e measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.|From enrollment to week 30 (end of self-administered dosing)|Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here|||Participants|||Count of Participants
2689368|NCT01327651|Secondary|A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm|Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product|From week 6 (randomization week) to week 30 (end of self-administered dosing)||||Participants|||Count of Participants
2689423|NCT01327339|Primary|Number of Participants With Any Adverse Event|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|one month|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments.|||participants|||Number
2689369|NCT01327651|Secondary|Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)|Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week|week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization|Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days|||Participants|||Count of Participants
2689370|NCT01327651|Primary|Self-reported Side Effect or Symptom Scores|The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||percent of visits between week 6 to 30|||Number
2689371|NCT01327651|Primary|The Total Pills Actually Used Over the Follow-up Period|The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||Number of pills actually used|||Number
2689372|NCT01327651|Primary|The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)|"Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are covered; Note: sex act is considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)"|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||Number of pills needed for 100% coverage|sexual exposure||Number
2689373|NCT01327651|Primary|Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing|"Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm."|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||percentage of sexual exposures|sexual exposures||Number
2689374|NCT01327599|Secondary|Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4|All subjects using Ganfort at baseline who received study medication and attended Week 4 visit.|||millimeters mercury (mmHg)||Standard Deviation|Mean
2689375|NCT01327599|Secondary|Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4, Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.|||percentage of participants|||Number
2689376|NCT01327599|Secondary|Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline|Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.|||units on a scale||Standard Deviation|Mean
2689433|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689377|NCT01327599|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.|||Units on a scale||Standard Deviation|Mean
2689378|NCT01327599|Primary|Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|All subjects using Ganfort at baseline who received study medication and attended Week 12 visit.|||millimeters mercury (mmHg)||Standard Deviation|Mean
2689379|NCT01327573|Primary|Group Difference Percentage Change in 6-month Estimated Glomerular Filtration Rate (eGFR)|"These data were calculated by mean 6-month eGFR minus baseline mean eGFR divided by baseline eGFR. Presented below are the between groups results. These results were derived from the results in the outcome Estimated Glomerular Filtration Rate (eGFR) at Months 2,3,4,5,6."|6 months|These are the between groups percent change that represents the difference between groups when controlling for baseline. Outcome measure #2 provides the data by treatment arm where these data are derived.|||percentage change||95% Confidence Interval|Least Squares Mean
2689380|NCT01327573|Primary|Estimated Glomerular Filtration Rate (eGFR) at Months 2,3,4,5,6|Primary statistical analysis of change from baseline was conducted with mixed effects modeling providing calculated estimates.|Months 2,3,4,5,6||||mL/min/1.73 m2||95% Confidence Interval|Least Squares Mean
2689381|NCT01327573|Primary|Baseline eGFR (Estimated Glomerular Filtration Rate)||Baseline||||mL/min/1.73 m2||95% Confidence Interval|Mean
2689382|NCT01327547|Secondary|Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48|The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.|Week 48|Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK and liver fibrosis biomarker data available.|||p-value|||Number
2689383|NCT01327547|Secondary|Summary of Estimated Maraviroc PK Parameters|Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.|Week 48|Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK data available.|||ng/mL||Full Range|Median
2689384|NCT01327547|Secondary|Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144|Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.|144 Weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
2689385|NCT01327547|Secondary|Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144|Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.|Week 144|Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.|||Numerical score||Full Range|Median
2689386|NCT01327547|Secondary|Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144|Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.|Baseline and Week 144|Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.|||Numerical score||Standard Deviation|Mean
2689434|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689387|NCT01327547|Secondary|Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144|Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||kPa||Standard Deviation|Mean
2689388|NCT01327547|Secondary|Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144|"The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1).~ELF score < 7.7: no to mild fibrosis; ≥ 7.7 — < 9.8: Moderate fibrosis; ≥ 9.8 — < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis."|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||ELF score||Standard Deviation|Mean
2689389|NCT01327547|Secondary|Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144|Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Log10 values||Standard Deviation|Mean
2689390|NCT01327547|Secondary|Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144|Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Log10 values||Standard Deviation|Mean
2689391|NCT01327547|Secondary|Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144|Plasma samples were used to determine markers of immune activation namely TGF beta.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||ng/L||Standard Deviation|Mean
2689392|NCT01327547|Secondary|Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144|Plasma samples were used to determine markers of immune activation namely D-Dimer.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||ng/dL||Standard Deviation|Mean
2689393|NCT01327547|Secondary|Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.|Plasma samples were used to determine markers of immune activation namely CRP.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||mg/dL||Standard Deviation|Mean
2689394|NCT01327547|Secondary|Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144|Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||cell/mm³||Standard Deviation|Mean
2689395|NCT01327547|Secondary|Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144|Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.|Week 48, 96 and 144|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Cells/µL||Standard Deviation|Mean
2689396|NCT01327547|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144|"The Food and Drug Administration (FDA's) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the virology-first principle and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF)."|Week 48, 96 and 144|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 144, LOCF was used if the value at that timepoint was missing.|||Percentage of participants|||Number
2689397|NCT01327547|Secondary|Number of Participants With Hy's Law Abnormalities Through Week 144|Hy's law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN|144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||participants|||Number
2689514|NCT01326780|Secondary|Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts|Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)|Baseline through Week 12||||Percent change||Standard Deviation|Mean
2689398|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L|Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144. The median time to development was not estimable due to too few events reported under each treatment group.|||Days||95% Confidence Interval|Median
2689399|NCT01327547|Secondary|Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L|Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
2689400|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities|Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.|144 weeks|Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144. The median time to development was not estimable due to too few events reported under each treatment group.|||Days||95% Confidence Interval|Median
2689401|NCT01327547|Secondary|Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144|Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.|Week 96 and 144|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
2689402|NCT01327547|Primary|Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48|Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the Full Analysis Set (FAS) which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
2689403|NCT01327508|Secondary|Distal Locking Time|Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.|Intraoperative||||minutes||Standard Deviation|Mean
2689404|NCT01327508|Primary|Radiation Exposure Measurement|"Radiation exposure measured in two ways:~Whole body badge TLD ring badge"|Intraoperative|Primary endpoint voided. Dosimeters did not capture radiation dose as expected.||||||
2689405|NCT01327495|Other Pre-specified|Progesterone||12 weeks||||ng/g||Inter-Quartile Range|Median
2689406|NCT01327495|Other Pre-specified|Pregnenolone||12 weeks||||ng/g||Inter-Quartile Range|Median
2689407|NCT01327495|Other Pre-specified|DHEA||12 weeks||||ng/g||Inter-Quartile Range|Median
2689408|NCT01327495|Other Pre-specified|Androsterone||12 weeks||||ng/g||Inter-Quartile Range|Median
2689409|NCT01327495|Other Pre-specified|Androstenedione||12 weeks||||ng/g||Inter-Quartile Range|Median
2689410|NCT01327495|Other Pre-specified|17-OHP||12 weeks||||ng/g||Inter-Quartile Range|Median
2689411|NCT01327495|Other Pre-specified|17-OHPreg||12 weeks||||ng/g||Inter-Quartile Range|Median
2689412|NCT01327495|Secondary|International Prostate Symptom Score (IPSS)|IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic|12 weeks||||units on a scale||Inter-Quartile Range|Median
2689413|NCT01327495|Secondary|Prostate Volume||12 weeks||||cm^3||Inter-Quartile Range|Median
2689414|NCT01327495|Secondary|Prostate Specific Antigen||12 weeks||||ng/dL||Inter-Quartile Range|Median
2689415|NCT01327495|Primary|Prostate Tissue Testosterone Concentrations After Treatment|To measure intraprostatic testosterone levels|12 weeks||||ng/g||Inter-Quartile Range|Median
2689416|NCT01327495|Primary|Dihydrotestosterone (DHT)||12 weeks||||ng/mL||Inter-Quartile Range|Median
2689417|NCT01327495|Primary|Serum Testosterone||12 weeks||||ng/mL||Inter-Quartile Range|Median
2689418|NCT01327495|Primary|Prostate Tissue DHT Concentrations After Treatment|To measure intraprostatic dihydrotestosterone [DHT] levels|12 weeks||||ng/g||Inter-Quartile Range|Median
2689419|NCT01327482|Secondary|Plasma Raltegravir Concentrations|Mean trough concentration from all 3 days|7, 14, 21 days||||ng/mL||Standard Deviation|Mean
2689420|NCT01327482|Primary|Tissue Raltegravir Concentrations|Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.|7, 14, 21 days||||ng/mL||Standard Deviation|Mean
2689421|NCT01327339|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|one month|ITT Population|||participants|||Number
2689422|NCT01327339|Secondary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|one month|ITT Population|||participants|||Number
2689424|NCT01327313|Secondary|Accumulation Ratio (Rac)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at 3rd infusion divided by area under the serum concentration-time curve within one complete dosing interval at 1st infusion.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 and Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2689425|NCT01327313|Secondary|Percentage Peak-Trough Fluctuation (PTF)|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [Cmax - Cmin] / Cav ) multiplied by 100.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
2689426|NCT01327313|Secondary|Mean Residence Time at Steady State (MRTss)|MRTss = (AUMCtau + tau(AUCinf - AUCtau))/ AUCtau) - T/2, where AUMCtau was the area under the first moment curve within one complete dosing interval and T was the infusion duration. Area under the serum concentration-time curve from time zero to infinity, calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
2689427|NCT01327313|Secondary|Mean Residency Time (MRT0-inf)|MRT0-inf of drug in the body was calculated by dividing the area under the first moment curve from time zero to infinity with area under the first moment curve from time zero to infinity minus half of infusion of duration (MRT0-inf = AUMC0-inf/AUMC0-inf - T/2).|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour||Geometric Coefficient of Variation|Geometric Mean
2689428|NCT01327313|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2689429|NCT01327313|Primary|Apparent Volume of Distribution: After Multiple Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/(Area under the serum concentration-time curve within one complete dosing interval [AUCtau]* λz) following multiple dose.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2689430|NCT01327313|Primary|Pharmacokinetics of EMD 525797 - Trough Values|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689431|NCT01327313|Primary|Apparent Volume of Distribution (Vz): After Single Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the serum concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. A minimum of three points is required to calculate λz.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||liter||Geometric Coefficient of Variation|Geometric Mean
2689432|NCT01327313|Primary|Total Body Clearance at Steady State (CLss) of EMD 525797|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL of drug in serum was calculated as : CL= Dose/ AUC0-inf. Area under the serum concentration-time curve from time zero to infinity (AUC0-inf), calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2689515|NCT01326780|Secondary|Change From Baseline in the Inflammatory Acne Lesion Counts|Change in sum of papules and pustules|Baseline through Week 12||||Lesions||Standard Deviation|Mean
2689435|NCT01327313|Secondary|Average Serum Concentration at Steady State (Cav)|The Cav was calculated by dividing the area under the serum concentration-time curve within one complete dosing interval (AUCtau) by the dosing interval (2 weeks or 336 hoursi.e. Cav =AUCtau/tau).|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689436|NCT01327313|Secondary|Observed Serum Concentration Immediately Before Next Dosing (Cpre)|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration)|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689437|NCT01327313|Secondary|Minimum Observed Serum Concentration (Cmin) After Multiple Doses|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689438|NCT01327313|Secondary|Elimination Rate Constant ( λ z): After Multiple Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||per hour||Geometric Coefficient of Variation|Geometric Mean
2689439|NCT01327313|Secondary|Elimination Rate Constant (λz): After Single Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||per hour||Geometric Coefficient of Variation|Geometric Mean
2689440|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour||Full Range|Median
2689441|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour||Full Range|Median
2689442|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour||Full Range|Median
2689443|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour||Full Range|Median
2689444|NCT01327313|Secondary|Progression-free Survival (PFS)|PFS time was defined as the time (in months) from the first dosing date to the date of first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST version 1.0) or death for any cause within 12 weeks after last tumor assessment. Subjects without event are censored on the date of last tumor assessment.|From first dosing date until disease progression or death, maximum up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.|||months||Full Range|Median
2689445|NCT01327313|Secondary|Number of Subjects With Clinical Benefit|Clinical benefit was defined as presence of at least one confirmed CR, PR, or stable disease (SD) lasting at least 12 weeks according to RECIST v1.0. Per RECIST v1.0: CR was defined as disappearance of all target and non-target lesions and normalization of serum levels of tumor markers . PR was defined as >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.|||subjects|||Number
2689446|NCT01327313|Secondary|Number of Subjects With Overall Tumor Response|Overall tumor response was defined as the presence of at least one confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Complete response was defined as the disappearance of all target and non-target lesions and normalization of serum levels of tumor markers. PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.|||subjects|||Number
2689516|NCT01326780|Secondary|Change From Baseline in the Non-inflammatory Acne Lesion Counts|Change in sum of open and closed comedones.|Baseline through Week 12||||Lesions||Standard Deviation|Mean
2689448|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Multiple Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above LLQ.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689449|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Single Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above Lower limit of quantification (LLQ).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689450|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax) of EMD 525797:After Multiple Dose||Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2689451|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax): After Single Dose||Pre-dose, hour 1(end of infusion [EOI]), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The pharmacokinetic (PK) analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2689452|NCT01327313|Primary|Number of Subjects With Dose-limiting Toxicities (DLTs)|DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring at any dose level until the end of Week 4, and suspected to be reasonably related to the investigational medicinal product by the Investigator and/or Sponsor. Toxicities not considered to be DLTs are as follows- Allergic reactions or anaphylaxis; any Grade 3 or 4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days, unless the Investigator decided this event is clinically significant. For this reason Grade 3 or 4 out-of-range laboratory values must be re-assessed within 7 days. In case the Investigator provides the subject any treatment(s) due to the out-of-range laboratory values, the event was regarded as a DLT.|Baseline up to Week 4|Dose escalation analysis set/DLT analysis set included all subjects who experienced a DLT or subjects who did not experience a DLT and had a relative dose intensity of >= 75 percent (%) during the DLT observation period.|||subjects|||Number
2689453|NCT01327300|Secondary|Intestinal Permeability Testing|"Ability of test substances to permeate the intestinal mucosa. The Lactulose/Mannitol test (Genova Diagnostics®, Ashville, NC) directly measures the ability of mannitol and lactulose to permeate the intestinal mucosa. Patient ingests 5 grams of lactulose and 2 grams of mannitol dissolved in a 100 ml of water. Urine is then collected for 24 hours and the ratio of the urinary excretion of lactulose to mannitol is measured. This testing is performed only after completion of each treatment period , after 12 weeks of mesalamine and after 12 weeks of placebo.~Normal ratio of lactulose/mannitol is any value <0.7. An abnormal ratio is defined as >0.7 ratio. The lactulose is measured in the urine as g/kg and the urinary excretion of mannitol is also measures as g/kg."|At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)||||ratio||Full Range|Mean
2689454|NCT01327300|Secondary|Hospital Anxiety and Depression Scale (HADS)|"A questionnaire is given to each patient with scoring done on a Likert scale ranking from 0-42 which combines anxiety and depression scales. Each of these are scored from 0-21 depending on anxiety versus the depression parameters. Comparison of change in HADs after 12 weeks of intervention with either mesalamine or placebo is provided here with only the total value provided-range is from 0-42.~Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 3 with zero being none at all or occasional and 3 as most of the time. The scale used is a Likert scale and therefore the data returned from the HADS is ordinal.~The best score for the HADS therefore is a 0 with the worst score a 42 for combined anxiety and depression scores.~For the subscales of depression and anxiety, the best score is a 0 and the worst is a 21. This data is not provided here.~Data below includes the change from baseline in the HADS scores."|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)||||units on a scale||Standard Deviation|Mean
2689455|NCT01327300|Secondary|IBS - Quality of Life (IBS-QOL)Score.|A questionnaire is given to each patient and was completed at baseline then after 12 weeks of intervention with mesalamine and then placebo in the cross-over study. The IBS-QOL comprises 34 items with 5-point response scales (0 to 4) that cover eight dimensions of HRQL: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items),food avoidance (3 items), social reaction (4 items), sexual concerns (2 items) and relationships (3 items). Higher values indicate better HRQL after converting the raw score on the IBS-QOL into 0 to 100 points.|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|Data are the mean change in IBS-QOL between baseline and intervention|||units on a scale||Standard Deviation|Mean
2689456|NCT01327300|Secondary|Functional Bowel Disorder Severity Index (FBDSI)|Subjects rate pain on a standardized scale. This is a standardized test used to evaluate patients with IBS. Baseline values are compared to 12 weeks after mesalamine and 12 weeks after placebo treatments. The FBDSI is score is interpreted as such: Severity of IBS is rated as none (0 points), mild (1-36 points), moderate as 37-110 points and severe as >110 points. Therefore patients can have a score higher than 110.|An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period.|Change in Functional Bowel Disorder Severity Index (FBDSI)after 12 weeks of intervention.|||units on a scale||Standard Deviation|Mean
2689517|NCT01326780|Primary|Change in Total Acne Lesion Counts|Change in lesion counts between baseline and end of study|Baseline to Week 12||||Lesions||Standard Deviation|Mean
2689457|NCT01327300|Secondary|Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline.|"Colonoscopy/flexible sigmoidoscopy will be performed and mucosal biopsies will be obtained. Each biopsy was stained for activated t lymphocytes, mast cells and eosinophils .~CD117 staining was done for Mast cells. H and E staining was used to identify lymphocytes and eosinophils. Each path specimen was then noted to have increased versus normal number of these inflammatory cells."|For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years)||||participants|||Number
2689458|NCT01327300|Primary|Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo|Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value provided.|Baseline and at 12 weeks post-intervention|The first part of the analysis compares the differences between baseline and mesalamine to baseline and placebo. The P value provided below list the comparison of baseline-placebo to baseline-mesalamine using the Mann-Whitney statistical analysis.|||units on a scale||Standard Deviation|Mean
2689459|NCT01327274|Secondary|Patient Satisfaction During the Treatment|. Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant|One month and one year after explant.|14 Participants offered recommendations at 2 time intervals|||Participants|||Count of Participants
2689460|NCT01327274|Secondary|Chest Wall Correction, by Pectus Severity Index|Though not powered to determine efficacy, preliminary efficacy data, as measured by pre and post treatment Pectus Severity Index (Haller Index), was also collected. Pre-treatment Haller Index was assessed based on computed tomography (CT) of the chest. One month after implant removal, patients underwent repeat chest CT to evaluate chest wall correction.|24 months|All patients who have received post-treatment chest wall imaging.|||Participants|||Count of Participants
2689461|NCT01327274|Secondary|Comfort and Brace Wear During Treatment|Comfort of the external brace directly affects compliance (i.e., bracewear) and compliance were be measured throughout treatment. In addition, the satisfaction of the patient and family will be measured using a standard Quality of Life (QOL) questionnaire administered 1 month after implanting the device and 1 month after removing the device.|During treatment, 24 months||||Participants|||Count of Participants
2689462|NCT01327274|Primary|Number of Participants With Adverse Reactions|All adverse reactions were recorded and reported, including complications from implantation of the device, complications from application of the external device over time (e.g., changes in skin; infection; changes in cardiac electrical function).|During treatment, 24 months||||Participants|||Count of Participants
2689463|NCT01327157|Other Pre-specified|Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale Whithout the Outlier.|"The correlation between the increase of the number of the dental contacts and VAS evaluation final result from chronic peripheral facial paralysis patients.~On this measure was excluded one outlier patient whose facial paralysis appeared in her childhood.~Observing the outlier patient, it was carried out a new scatterplot, ignoring her."|Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||correlation coefficient|||Number
2689464|NCT01327157|Other Pre-specified|Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale .|The correlation between the increase of the number of the dental contacts and the VAS evaluation final result from chronic peripheral facial paralysis patients, according to control and treated groups by the neuro occlusal rehabilitation technic.|Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||correlation coefficient|||Number
2689465|NCT01327157|Secondary|Visual Analog Scale|"It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002).~Patients were asked to fill the VAS with the following questions. Do you chew well? How would you classify your chewing at the moment? If you have no trouble chewing, the rating is zero. If you have any discomfort when you chew, your reference level is five. If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale."|After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||units on a scale||Standard Deviation|Mean
2689466|NCT01327157|Primary|Brand Carbon Count on Gnathostats Models|Only in the treatment group were done gnatostatic models.The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between the upper and lower mandibles), and used carbon to count the the number of dental contacts, through the brand carbon made on the model, The dental contacts were counted in the models before and after treatment. The models are made in the first and last query.|Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||number of dental contacts||Standard Deviation|Mean
2689467|NCT01327157|Primary|The Visual Analog Scale for Pain Was Used to Grade Discomfort in Chewing After the Installation of Facial Paralysis. Level Zero is the Lack of Discomfort and 10 is the Maximum Degree of Discomfort.|"It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002).~Patients were asked to fill the VAS with the following questions.~Do you chew well?~How would you classify your chewing at the moment?~If you have no trouble chewing, the rating is zero.~If you have any discomfort when you chew, your reference level is five.~If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale."|Day 1 (Day 91 for Treatment participants first receiving Placebo)|All participants were treated by intention to treat.|||units on a scale||Standard Deviation|Mean
2689631|NCT01325311|Secondary|Serum Calcium Levels at Baseline and Pre-Surgery|This is a measurement of calcium in the Blood serum at baseline and at the end of the study.|Baseline and Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.|||ng/mL (absolute change)||Standard Deviation|Mean
2689468|NCT01327053|Secondary|Overall Survival (OS)|OS is defined as the time from date of randomization to date of death due to any cause or the last date that a patient was known to be alive (censored observation) as of the data cut-off.|42 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Months||95% Confidence Interval|Median
2689469|NCT01327053|Secondary|Plasma Concentration of Sonidegib (LDE225)|Blood PK samples were collected either by direct venipuncture or an indwelling cannula inserted in a forearm vein for the determination of trough (Cmin) plasma concentrations of sonidegib and its main circulating metabolite, LGE899, from all patients who enrolled in the study. Blood was collected in Weeks 1, 3, 5, 9 (pre-dose), and subsequently pre-dose every 4 weeks up to Week 21, and every 12 weeks thereafter up to week 69.|Weeks 1, 3, 5, 9, 13, 17, 21, 33, 45, 57, 69|The PK analysis set (PAS) consisted of all patients with at least one evaluable plasma concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2689470|NCT01327053|Secondary|Time to Tumor Response (TTR) Per Site Investigator Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)|Time to tumor response (TTR) is defined as the time from date of enrollment to the date of first documented tumor response (CR or PR). PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Months||95% Confidence Interval|Median
2689471|NCT01327053|Secondary|Progression-free Survival (PFS) Per Site Investigator Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Months||95% Confidence Interval|Median
2689472|NCT01327053|Secondary|Duration of Response (DoR) Per Site Investigator Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (FAS)|Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason. Duration of response was for participants with ORR. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|42 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Months||95% Confidence Interval|Median
2689473|NCT01327053|Secondary|Duration of Response (DoR) Per Site Investigator Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Duration of response was for participants with ORR. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.~Progressive disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2."|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Months||95% Confidence Interval|Median
2689474|NCT01327053|Secondary|Objective Response Rate (ORR) Based on Site Investigator Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS)|ORR is the percentage of patient's objective response (ORR) by 6 months after starting LDE225 treatment. A responder was defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 42 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|42 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).|||Percentage of participants||95% Confidence Interval|Number
2689492|NCT01326962|Primary|Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, ‘n’ = number of participants analyzed at particular point of time.|||Units on a scale|||Number
2700355|NCT01243320|Primary|Change In Glucose Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
2689475|NCT01327053|Secondary|Objective Response Rate (ORR) Based on Site Investigator Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS)|ORR is the percentage of patient's objective response (ORR) by 42 months after starting LDE225 treatment. A responder was defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 42 months after starting LDE225 treatment. Treatment with sonidegib was considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Percentage of participants||95% Confidence Interval|Number
2689476|NCT01327053|Secondary|Time to Tumor Response (TTR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (FAS)|Time to tumor response (TTR) is defined as the time from date of enrollment to the date of first documented tumor response (CR or PR). PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|42 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).|||Months||95% Confidence Interval|Median
2689477|NCT01327053|Secondary|Time to Tumor Response (TTR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)|Time to tumor response (TTR) is defined as the time from date of enrollment to the date of first documented tumor response (CR or PR). PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Months||95% Confidence Interval|Median
2689478|NCT01327053|Secondary|Progression-free Survival (PFS) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (FAS)|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.|42 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).|||Months||95% Confidence Interval|Median
2689479|NCT01327053|Secondary|Progression-free Survival (PFS) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Months||95% Confidence Interval|Median
2689480|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review (FAS)|"Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of 'Unknown will be treated as non responders"|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Percentage of participants||95% Confidence Interval|Number
2689481|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review (pEAS)|"Rate of complete response is the percentage of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR was determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of 'Unknown were treated as non responders. Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm."|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Percentage of participants||95% Confidence Interval|Number
2689482|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (FAS)|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Median DoR for patients with laBCC was non-estimable for both treatment arms. Duration of response was for participants with ORR. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm."|42 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Months||95% Confidence Interval|Median
2689504|NCT01326845|Secondary|Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups||3 months, 6 months|||||||
2689505|NCT01326845|Secondary|the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months|||||||
2689483|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Duration of response was for participants with ORR. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.~Progressive disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2."|42 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Months||95% Confidence Interval|Median
2689484|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS)|ORR is the percentage of patient's objective response (ORR) by 6 months after starting LDE225 treatment. A responder was defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).|||Percentage of participants||95% Confidence Interval|Number
2689485|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS)|ORR is the percentage of patient's objective response (ORR) by 6 months after starting LDE225 treatment. A responder was defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.|6 months|The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, & including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.|||Percentage of participants||95% Confidence Interval|Number
2689486|NCT01326962|Secondary|Number of Participants With Erythrocyte Sedimentation Rate Abnormality|ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
2689487|NCT01326962|Secondary|Number of Participants With C-Reactive Protein Abnormality|CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||mg/L|||Number
2689488|NCT01326962|Secondary|Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
2689489|NCT01326962|Secondary|Number of Participants With AE or SAE Related Discontinuation of Tocilizumab|It included participants who discontinued from the study due to occurrence of AE or SAE.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.|||participants|||Number
2689490|NCT01326962|Secondary|Number of Participants With Any Adverse Event and Serious Adverse Event|An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.|||participants|||Number
2689491|NCT01326962|Primary|Change in Fatigue as Measured Using the Fatigue Visual Analog Scale|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||units on a scale|||Number
2689493|NCT01326962|Primary|Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response|Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
2689494|NCT01326962|Primary|Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)|DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
2689495|NCT01326962|Primary|Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
2689496|NCT01326962|Primary|Time to Das28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.|||Day||Standard Error|Mean
2689497|NCT01326962|Primary|Number of Participants Who Achieved Remission (DAS28 < 2.6)|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
2689498|NCT01326962|Primary|Disease Activity as Measured by Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.|||units on a scale||Inter-Quartile Range|Median
2689499|NCT01326910|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA)|An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.|through Week 3|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2689500|NCT01326910|Secondary|Assessment of Itch|Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable|through Week 3|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2689501|NCT01326910|Secondary|Interim Eczema Area and Severity Index (EASI)|Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.|Week 2|Intention to Treat|||participants|||Number
2689502|NCT01326910|Primary|Eczema Area and Severity Index (EASI)|A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72|3 weeks|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2689503|NCT01326845|Secondary|Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months|||||||
2689518|NCT01326728|Other Pre-specified|Recovery of Clinical Immunity After Allotransplant|Improved serologic responses after allotransplant.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689519|NCT01326728|Other Pre-specified|Relapse After Day 100 or Following Treatment of Graft Versus Host Disease (GVHD)|Participants who were initially in remission.|After Day 100 or Following Treatment of GVHD|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689520|NCT01326728|Other Pre-specified|Tumor Immune Response Graft-Versus-Leukemia (GVL)|GVL is a donor anti-tumor response following transplant.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689521|NCT01326728|Other Pre-specified|Regimen-Specific Sensitivity After Allotransplant|Regimen-specific sensitivity are new or renewed sensitivity to therapies following allotransplant.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689522|NCT01326728|Other Pre-specified|Count of Participants With Clinical Blood Markers of Inflammation|Count of participants with clinical blood markers of inflammation. Normal to low blood markers indicate relapse. Falling blood marker levels indicate possible imminent relapse.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689523|NCT01326728|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|5 years||||Participants|||Count of Participants
2689524|NCT01326728|Primary|Count of Participants With Infection After Allotransplant|Count of Participants with Infection After Allotransplant.|up to 100 days or more post allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689525|NCT01326728|Primary|Count of Participants With Chronic Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant|Mild chronic GVHD involves only 1 or 2 organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites). Moderate GVHD involves at least 1 organ or site with clinically significant but no major disability (max. score of 2 in any affected organ or site), or 3 or more organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites), and a lung score of 1 will also be considered moderate chronic GVHD. Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site). A lung score of 2 or greater will also be considered severe chronic GVHD.|100 days post allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689526|NCT01326728|Primary|Count of Participants With Acute Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant|Acute GVHD is defined as GVHD that presents with signs and symptoms typical of acute GVHD but presenting after day 100 post allotransplant. Clinical Staging Grade 2 ((+) to (+++) Skin; (+) Liver; and (+) Gut) involvement, Grade 3 ((++) to (+++) Skin; (++ to +++) Liver; and (++ to +++) Gut) involvement, and Grade 4 ((++) to (++++) Skin; (++ to ++++) Liver; and (++ to ++++) Gut) involvement.|100 days or more post allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689527|NCT01326728|Primary|Days to Engraftment|Number of days for a participant to reach engraftment.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689528|NCT01326728|Primary|Overall Survival|Overall Survival is the time between the first day of treatment to the day of death.|first day of treatment to the day of death|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2700356|NCT01243320|Primary|Change In CreatinineBlood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
2689529|NCT01326728|Primary|Time to Progression After Allotransplant|Time to Progression is the time between the first day of treatment to day 100 after allotransplant.|first day of treatment to day 100 after allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689530|NCT01326728|Primary|Immune Suppression|Biological response to agents and or treatments that can lead to bone marrow suppression/ cytopenias and sometimes death.|up to 100 days or more following transplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
2689531|NCT01326702|Secondary|Participants With Dose Limiting Toxicities||28 days||||participants|||Number
2689532|NCT01326702|Secondary|Progression-free Survival Using RECIST Version 1.1 (Phase IIa)|Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.|2 years|Participants treated on Dose Level 7 make up the cohort expansion of VBR in participants with CD20+ B-cell lymphoma.|||Months||Full Range|Median
2689533|NCT01326702|Secondary|Pharmacokinetic Parameters of Veliparib (Phase Ib)|Area Under the Curve from time zero to 12 hours following Veliparib administration|From time zero to 12 hours on day 2 of course 1||||μg*h/mL||Standard Deviation|Geometric Mean
2689534|NCT01326702|Secondary|Overall Survival (Phase IIa)|Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed.|Up to 30 days post-treatment|Data were not collected||||||
2689535|NCT01326702|Secondary|Duration of Remission (Phase IIa)||From the first documented response to the first documented progression or death, assessed up to 30 days post-treatment|Data were not collected||||||
2689536|NCT01326702|Secondary|Complete Response (CR) to Study Treatment (Phase IIa)|Summary statistics will be used for CR. Responses will be evaluated by the International Uniform Response Criteria for Multiple Myeloma.|2 years|Dose Level 7; Bendamustine 90mg/m2, ABT-888 400mg BID Participants treated on Dose Level 7 make up the cohort expansion of VBR in participants with CD20+ B-cell lymphoma.|||Participants|||Count of Participants
2689537|NCT01326702|Primary|Number of Participants With Adverse Events|Adverse events assessed by NCI CTCAE version 4.0 (Phase Ib) See adverse events section.|2 years||||participants|||Number
2689538|NCT01326702|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|2 years||||Participants|||Count of Participants
2689539|NCT01326702|Primary|Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride|Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.|28 days|The MTD was established at Dose Level 6 Veliparib 300mg PO BID plus Bendamustine 90 mg/m2|||mg|||Number
2689540|NCT01326546|Secondary|Histological Response|Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.|72 weeks|||||||
2689541|NCT01326546|Secondary|Biochemistry Response|Biochemistry response at every observation time, mean the ALT level reduce to normal.|96 weeks|||||||
2689542|NCT01326546|Secondary|Virological Response|Virological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level <1.72×104 IU/ml.|96 weeks|||||||
2689543|NCT01326546|Secondary|Serological Response|Serological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg.|96 weeks|||||||
2689544|NCT01326546|Primary|Percentage of Participants With HBeAg Seroconversion at Week 48|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|48 weeks|Intention-To-Treat Population|||Participants|||Count of Participants
2689545|NCT01326533|Secondary|Beta Cell Function|Change from baseline in the disposition index (DI)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data|||arbitrary units||Standard Error|Mean
2689546|NCT01326533|Primary|Insulin Sensitivity|Change from baseline in the insulin sensitivity index (Si)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data|||10^-4/pmol*l/min||Standard Error|Mean
2689547|NCT01326481|Secondary|Number of Patients With Objective Response According to RECIST 1.1|The best response according to RECIST 1.1 for each patient with measurable disease who received at least one dose of study drug will be listed by cohort and tumor type|1.5 years|Patients who had measurable disease at baseline and received at least one follow up scan were evaluable for the primary efficacy outcome of ORR by RECIST 1.1|||Participants|||Count of Participants
2689548|NCT01326481|Secondary|Number of Patients With Positive Immune Response to TRC105|Serial blood samples will be tested for anti-drug antibody (ADA) immune response to TRC105. Patients who are positive at baseline (prior to receiving TRC105) are excluded from analysis.|1.5 years|All patients who received at least a portion of a dose of TRC105|||Participants|||Count of Participants
2689549|NCT01326481|Secondary|TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D|Mean trough concentration for patients dosed at 10 mg/kg at cycle 2 day 1|Cycle 2 day 1 (3 weeks)|All patients who received full TRC105 doses of 10 mg/kg in cycle 1.|||ng/mL||Full Range|Mean
2689550|NCT01326481|Primary|Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine|Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.|1.5 years|All patients who received at least a portion of a dose of TRC105 enrolled in the dose escalation portion of the study|||Participants|||Count of Participants
2689551|NCT01326026|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
2689552|NCT01326026|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
2689553|NCT01326026|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Events/100 years of patient exposure|||Number
2689554|NCT01326026|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
2689555|NCT01326026|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2689556|NCT01325870|Secondary|Mean Intrathoracic Pressure (Airway Pressure)|Intrathoracic pressures are reported relative to atmospheric pressure|during CPR (day 1)||||mmHg||Standard Deviation|Mean
2689557|NCT01325870|Primary|Serious Adverse Events|Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR|during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up||||events|||Number
2689558|NCT01325870|Primary|Mean Systolic and Diastolic Blood Pressures||during CPR (day 1)||||mmHg||Standard Deviation|Mean
2689559|NCT01325792|Secondary|Early and Long-term Complication Rates|Surgical site abdominal wound event rate|after surgery (day 1) to 24 months||||% of subjects with events|||Number
2689560|NCT01325792|Primary|Hernia Recurrence Rate|Investigator confirmed hernia recurrence by physical examination|at about 24 months||||% of subjects with recurrent hernia||95% Confidence Interval|Number
2689561|NCT01325714|Secondary|Caregiver-perceived Mutuality|"Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale.~Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal.~responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported mutuality.|||units on a scale||Standard Deviation|Mean
2689562|NCT01325714|Secondary|Caregiver Burden|"Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always.~Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver burden.|||units on a scale||Standard Deviation|Mean
2689563|NCT01325714|Secondary|Pleasant Events - Short Form - Alzheimer's Disease|"The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease.~For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no).~For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together.~The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events."|Baseline, 0, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events.|||units on a scale||Standard Deviation|Mean
2689564|NCT01325714|Secondary|Depression|"Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item.~Total GDS scores range from 0 to 30, with greater scores indicating greater depression."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
2689632|NCT01325311|Secondary|Total PSA in Serum|This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.|at Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Median
2689565|NCT01325714|Secondary|Patient-reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
2689566|NCT01325714|Secondary|Caregiver Reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months.|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
2689567|NCT01325714|Secondary|Patient-reported Worst Pain.|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in patient-reported worst pain.|||units on a scale||Standard Deviation|Mean
2689568|NCT01325714|Secondary|Caregiver-Reported Worst Pain|"This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity"|Baseline, 3 months, 6 months, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
2689569|NCT01325714|Primary|Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)|"The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred less than once a week or more often) and disruptiveness (i.e., it was a little disruptive or more), he/she was considered aggressive.~Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors.~One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors.~One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors."|Three Months, Six Months, Twelve Months Post Intervention|203 community-dwelling Veterans with pain and dementia and their caregivers|||participants|||Number
2689570|NCT01325701|Secondary|Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|"Treatment Group 1 PK collection schedule:~Cycle 1 Day 1: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 8: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose~Treatment Group 2 PK collection schedule:~Cycle 1 Day 8: Pre-dose, 1, 2, 4 and 7 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose Cycle 3 Day 1: Pre-dose, 1, 2, and 4 hours post-dose"|Performed during the first month of receiving study drug.|PK samples were collected in all participants (n=70 and 8 in PCI-32765: 560 mg and 840 mg, respectively). Of these, 59 participants in PCI-32765: 560 mg and 7 in PCI-32765: 840 mg on Cycle 1 Day 8 were evaluable for PK.|||ng*h/mL||Standard Deviation|Mean
2689571|NCT01325701|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Participants will be followed until progression of the disease or start of another anticancer treatment. The clinical database captured all AEs from baseline through end of treatment. Treatment Emergent AEs were collected pre-dose, at the beginning of each cycle and 30 days post last dose of study drug, unless related to study drug.|Adverse events determined to be related to study drug are collected from first dose until study exit (approximately 3 years).||||participants|||Number
2689572|NCT01325701|Primary|Percentage of Patients With an Overall Response to Study Drug|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator.|The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months)||||percentage of participants|||Number
2689573|NCT01325623|Secondary|Post-stimulation Heart Rate Changes|During a 1 hour period during the EMU stay, the VNS Therapy device was programmed to normal mode stimulation ON time 30 seconds, OFF time 5 minutes. AutoStim and Magnet Mode were programmed OFF. In this hour, 10 to 11 normal mode stimulations can be expected. Around each of these stimulations, ECG data were collected to assess potential stimulation related heart rate changes (during stimulation, after stimulation and after black-out time). A black-out time is a period after stimulation during which no seizure detections can occur, to ensure that potential stimulation related heart rate changes were not seen as ictal tachycardia that would trigger false positive detection. During the trial, the black-out time was programmed to 30 seconds. The heart rate changes for all stimulations and all patients were averaged.|EMU stay|ITT population|||percentage change||Standard Deviation|Mean
2689574|NCT01325623|Secondary|Overall Summary of Seizure Intensity by Subgroup|Quantitative evaluation of EEG was used to characterize the seizures that were treated with Automatic Stimulation. Intensity was evaluated by surveying the average power level from the 10-20 system EEG channel of maximum output during the course of the seizure. Intensity was only reported for seizures with intensity annotated and >= 20% Heart Rate Rise. The relative intensity was calculated by normalizing the power calculations to the pre-seizure state, and thus the reported changes are dimensionless. n= number of seizures|Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay|Patients from the ITT population who had at least one seizure during EMU stay and who had at least one historical seizure recorded. n=total number of seizures|||unitless||Standard Deviation|Mean
2689633|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP27B1|This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.|Up to Day 35||||Ratio to Baseline||Standard Deviation|Geometric Mean
2689575|NCT01325623|Secondary|Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)|Quality of life data was collected using patient‐completed QOLIE‐31‐P surveys and compared between baseline and follow‐up visits. The MIC score for each subscale defines the threshold for Minimally Important Change. If a score exceeds the MIC Score, the improvement from baseline is considered clinically significant. The range for QOLIE-31-P (all sub-scores) is 0-100 with higher scores reflecting greater well-being.Subscale scores were averaged to compute the QOLIE Total Score.|up to 24 Months Visit|ITT Population|||units on a scale||Standard Deviation|Mean
2689576|NCT01325623|Secondary|Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Post-ictal duration was quantified by identifying the time at which the number of EEG channels within the 95% confidence interval of relative power reaches a number that is consistent with that during the pre-seizure period. This measure represents the amount of time required following a seizure until the EEG recovers to the pre-seizure state. It is used to objectively estimate patient recovery time. Historical seizures were baseline EEG recordings measured during monitoring prior to implantation. Post-ictal duration is only reported for seizures with Post Ictal Duration (seconds) annotated and >= 20% Heart Rate Rise|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures|||Seconds||Standard Deviation|Mean
2689577|NCT01325623|Secondary|Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Seizure duration was calculated using historical EEG data from patients enrolled in the trial and compared to the duration of seizures that occurred during the study EMU stay. The seizure start and end times were determined via clinical observation and/or through an adjudication process with qualified EEG reviewers.|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures|||Seconds||Standard Deviation|Mean
2689578|NCT01325623|Secondary|Proportion of Seizures Ending During Stimulation by Type|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population; All Treated Seizures n=total number of seizures|||Percentage of Seizures Ending|||Number
2689579|NCT01325623|Secondary|Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 and 24 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.~Mean SSQ scores at 3, 6, 12, 18 and 24 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire. Subscale scores were averaged to compute the SSQ Total Score"|Up to 24 Month visit|ITT Population|||Units on a scale||Standard Deviation|Mean
2689580|NCT01325623|Secondary|Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.~Negative median value means improvement."|up to 24 Months Visit|ITT Population|||Units on a scale||Full Range|Median
2689581|NCT01325623|Secondary|Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6, 12, 18 and 24 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 24 Month visit|ITT population|||Percentage of participants||95% Confidence Interval|Number
2689582|NCT01325623|Secondary|Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from Extremely Difficult (5) to Extremely Easy (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery and the end of EMU.~Usability was calculated as percentage of the users who found the usability of system to be easy-2 or extremely easy-1."|At implant/recovery up to EMU Discharge (2 to 4 weeks)|ITT Population|||Percentage of participants rated 1 or 2|||Number
2689583|NCT01325623|Secondary|Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting|Latency is defined as the time difference between SDA detection time and the annotated seizure onset time. The earliest SDA detection was considered for each seizure. Seizure onset times were compared with M106 device detections at the randomized SDA setting. Negative latencies indicate that the SDA detection preceded the seizure onset time. The median latency is presented for seizures which met the definition of ictal tachycardia as well as all seizure types and indicate the observed latency range.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population n=total number of seizures in each category|||seconds||Full Range|Median
2689584|NCT01325623|Secondary|Validation of Cardiac R-Wave Detection|Cardiac R‐wave detection was evaluated against concurrent ECG data (i.e. detailed R‐wave test) collected during implant, the first titration visit, at the beginning of the EMU stay, and at the 12 month visit. R‐R intervals were calculated using detected R‐waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre‐specified time interval. A time series 10 seconds was recorded using the IPG SyncPulse feature. Simultaneously, a corresponding time series over the same interval was recorded using a standard ECG monitor. The total number of beats accurately detected in the entire study population is reported.|At Implant, First Titration Visit, Day 1 EMU and 12 Months|ITT population|||percentage of beats accurately detected|||Number
2689585|NCT01325623|Primary|Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Potential false positive rate is defined as the sum across all patients of the total number of potential false positive detections divided by the sum across all patients of the appropriate monitoring time during the EMU stay. Data used to support the potential false positive rate analyses included digital ECG/EEG files retrieved from the EMU evaluation, corresponding M106 device downloads, and triple review results of EEG recordings.~The evaluated EMU monitoring time includes a daily 3 minutes stepping exercise during which patients stepped up and down on a step stool at a submaximal effort leve."|Epilepsy Monitoring Unit (EMU) Stay|"ITT Population: all patients implanted with Model 106 VNS Therapy System Version 2 and who have any EMU record.~10 participants analyzed for >=60% setting, 12 participants analyzed for >=40% setting, 8 participants analyzed for >=20% setting."|||Potential False Positive per Hour||95% Confidence Interval|Number
2689586|NCT01325623|Primary|Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).|||percentage of True Positive Detections||95% Confidence Interval|Mean
2689587|NCT01325623|Primary|Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Sensitivity is the total number of seizures detected divided by the total number of seizures during EMU stay.Data used to support sensitivity analyses included digital ECG/EEG files,corresponding M106 device downloads,and CRF data.Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define EEG seizure onset times.Seizure onset times were then compared with observed M106 device detections at the detection threshold setting for AutoStim that the patient was randomized to(SDA 2;60%,SDA 4;40%,SDA 6;20%).Sensitivity is only reported if the heart rate surpassed the programmed detection threshold.Number of participants is total number of subjects who had seizures during the EMU stay.~An Ictal tachycardia Seizure is a seizure with Ictal Heart rate >= 100 bpm & at least 55% increase, or 35 bpm increase from baseline) Bootstrap confidence intervals using 3000 bootstrap samples. n=total number of seizures; N= number of participants"|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).|||percentage of True Positive Detections||95% Confidence Interval|Mean
2689588|NCT01325623|Primary|Summary of Seizures Reported by Investigators and Triple Review|"Subjects were admitted to the EMU and underwent standard continuous data collection of vEEG and ECG for 3 to 5 days. If a seizure occurred during the EMU stay, clinical investigators annotated the start and stop times, the type of seizure, the presumed seizure onset location, and the lobe of origin as applicable.~Following the EMU data collection phase of the trial, the de-identified, continuous electronic records (per patient) from the EMU period were provided to an independent and blinded triple review panel. This panel evaluated the EEG data and annotated seizure onset, seizure offset, and a description of seizure type. In the absence of video, seizure types could only be specified as: partial (particular type not denoted), generalized (non-absence), absence, or partial with secondary generalization."|Epilepsy Monitoring Unit Stay|ITT Population: consists of all patients implanted with the AspireSR VNS Therapy System version 2 and who have any EMU record.|||Seizures|||Number
2689589|NCT01325584|Primary|Average Improvement in ALT|Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||U/L||Full Range|Mean
2689590|NCT01325584|Primary|Average Improvement in AST|Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||U/L||Full Range|Mean
2689591|NCT01325584|Primary|Number of Patients Experiencing Adverse Events|The number of patients reporting or experiencing adverse effects will be reported.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||Participants|||Count of Participants
2689592|NCT01325584|Primary|Average Change in Alkaline Phosphatase|lab values will be summarized at baseline and as change from baseline to worst follow-up value.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.|Average Improvement in Alkaline Phosphatase|||U/L||Full Range|Mean
2689593|NCT01325584|Primary|Maximum Conjugated Bilirubin|Highest detected lab values will be summarized between baseline and end of study participation.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||mg/dl||Standard Deviation|Mean
2689594|NCT01325532|Secondary|Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.|The Pittsburgh Sleep Quality Index (PSQI) is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study. Scoring is based on 7 individual components. Each component is scored from 0-3. Higher scores indicate worse sleep. Total global sleep score ranges from zero (0) to 21. We report here the overall change in global sleep score for each treatment arm, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of sleep disturbance (improvement), whereas a score of less than zero indicates an increase in sleep disturbance (worsening).|Baseline-Week 3|This is an intent to treat (ITT) analysis of all patients randomized.|||units on a scale||Standard Deviation|Mean
2689595|NCT01325532|Primary|Reported Side Effects Based on PRISE AE Scores|This measures the emergence of different adverse (side) effects from treatment during the study. This section will describe the most commonly reported adverse effects. The section on adverse events will describe and detail the full range of AEs reported.|Baseline-Week 3|Intent to treat sample with all subjects randomized.|||number of subjects reporting|||Number
2689596|NCT01325532|Primary|Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3|The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. This section reports the improvement in depressive symptoms during the course of treatment, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of depressive symptoms (improvement), whereas a score of less than zero indicates an increase in depressive symptoms (worsening).|Baseline-Week 3|Intent to treat sample with last observation carried forward for all randomized subject.|||units on a scale||Standard Deviation|Mean
2689597|NCT01325493|Secondary|Pain Score During Cough.|Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively||||pain score at cough||Standard Deviation|Mean
2689598|NCT01325493|Secondary|Pain Score at Rest|Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively||||pain score at rest||Standard Deviation|Mean
2689599|NCT01325493|Secondary|Sedation Score|"Sedation scores 0 = completely awake~= sleepy but responds appropriately~= somnolent but arouses to light stimuli~= asleep but responsive to deeper physical stimuli~= asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery."|24, 48, 72, 96 hours post operatively||||Sedation Score||Standard Deviation|Mean
2689600|NCT01325493|Primary|Morphine Equivalent Consumption (mg/kg)|Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.|at 24, 48, 72, 96 hours post operatively||||mg/kg||Standard Deviation|Mean
2689601|NCT01325428|Secondary|Progression Free Survival Over the Whole Sudy.|PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.|From first drug administration until end of study, up to 700 days.|"TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.~TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B."|||Days||95% Confidence Interval|Median
2689602|NCT01325428|Secondary|Part B: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.|From first drug administration until end of Part B, up to 230 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Days||95% Confidence Interval|Median
2689603|NCT01325428|Secondary|Part A: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.|From first drug administration until end of Part A, up to 713 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Days||95% Confidence Interval|Median
2689604|NCT01325428|Secondary|Part B: Duration of Unconfirmed Objective Response.|Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).|From first drug administration until end of Part B, up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Days||95% Confidence Interval|Median
2689605|NCT01325428|Secondary|Part A: Duration of Unconfirmed Objective Response.|Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).|From first drug administration until end of Part A, up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Days||95% Confidence Interval|Median
2689606|NCT01325428|Secondary|Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Percentage of participants||95% Confidence Interval|Number
2689607|NCT01325428|Secondary|Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Percentage of participants||95% Confidence Interval|Number
2689608|NCT01325428|Secondary|Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Percentage of participants||95% Confidence Interval|Number
2690360|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2689609|NCT01325428|Secondary|Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Percentage of participants||95% Confidence Interval|Number
2689610|NCT01325428|Primary|Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Percentage of participants||95% Confidence Interval|Number
2689611|NCT01325428|Primary|Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Percentage of participants||95% Confidence Interval|Number
2689612|NCT01325350|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Intensity units||Standard Deviation|Mean
2689613|NCT01325350|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||mm/cm^2||Standard Deviation|Mean
2689614|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
2689615|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
2689616|NCT01325350|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
2689617|NCT01325350|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||terminal hairs/cm^2||Standard Deviation|Mean
2689634|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP24|This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.|Baseline and Up to Day 35|Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome.|||Ratio to Baseline||Standard Deviation|Geometric Mean
2689618|NCT01325337|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Intensity units||Standard Deviation|Mean
2689619|NCT01325337|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||mm/cm^2||Standard Deviation|Mean
2689620|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
2689621|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
2689622|NCT01325337|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
2689623|NCT01325337|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||terminal hairs/cm^2||Standard Deviation|Mean
2689624|NCT01325311|Secondary|Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)||up to Day 35||||percentage of participants|||Number
2689625|NCT01325311|Secondary|Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized case data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence."|Up to day Day 35|Due to sample in Arm II one participants data was not analyzed.|||Normalized Optical Density||Standard Deviation|Mean
2689626|NCT01325311|Secondary|Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized control data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence."|Up to Day 35||||Normalized Optical Density||Standard Deviation|Mean
2689627|NCT01325311|Secondary|Total PTH in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm I was not analyzed.|||ng/mL||Standard Deviation|Mean
2689628|NCT01325311|Secondary|Total IGFBP-3 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.|Baseline and Up to Day 35|Due to sample one participant from Arm 1 was not analyzed.|||ng/mL||Standard Deviation|Mean
2689629|NCT01325311|Secondary|Total IGF-2 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed.|||ng/mL||Standard Deviation|Mean
2689630|NCT01325311|Secondary|Total IGF-1 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.|Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Mean
2700357|NCT01243320|Primary|Change in Urea Nitrogen Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
2689635|NCT01325311|Secondary|Levels of Calcitriol in Participants Serum|This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.|baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Mean
2689636|NCT01325311|Primary|Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms|To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein|up to 35 days||||participants|||Number
2689637|NCT01325311|Secondary|Levels of Calcidiol in the Participants Serum|This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study|Baseline and up to day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Mean
2689638|NCT01325311|Primary|Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms|This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein|up to Day 35||||ng/mL||Standard Deviation|Mean
2689639|NCT01325207|Post-Hoc|Median Overall Survival (OS) in Treatment With Intrathecal Trastuzumab for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.|Overall Survival (OS) will be measured from start of treatment until death from any cause. To estimate OS, Kaplan-Meier curves will be calculated and median OS will be determined from the progression-free survival curve.|From start of treatment until death from any cause for up to 60 months.|Cohort results for this outcome measure were analyzed both combined and for patients treated at the MTD dose of 80mg IT as the objective was to determine preliminary data on OS of patients with this drug combination|||percentage of patients||95% Confidence Interval|Median
2689640|NCT01325207|Post-Hoc|Median Progression Free Survival (PFS) in Treatment With Intrathecal Trastuzumab for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.|Progression Free Survival (PFS) will be measured from the time of treatment initiation until the first documentation of progression. To estimate PFS, Kaplan-Meier curves will be calculated and the median PFS will be determined from the progression-free survival curve. Progression will be defined as worsening clinical signs or development of new clinical symptoms that the Investigator feels can be attributed to Leptomeningeal disease.|From start of treatment, and during treatment until progressive disease for up to 30 months.|Cohort results for this outcome measure were analyzed both combined and for patients treated at the MTD dose of 80mg IT as the objective was to determine preliminary data on PFS of patients with this drug combination|||Months||95% Confidence Interval|Median
2689641|NCT01325207|Post-Hoc|Overall Survival (OS) at 6 and 12 Months in Treatment With Intrathecal Trastuzumab for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.|Overall Survival (OS) will be measured from the time of treatment initiation until death from any cause. To estimate OS probability at 6 and 12 months, Kaplan-Meier curves will be calculated and OS at 612 months will be determined from the overall survival curve.|At 6 and 12 months from start of treatment|Cohort results for this outcome measure were analyzed both combined and for patients treated at the MTD dose of 80mg IT as the objective was to determine preliminary data on OS of patients with this drug combination.|||Probability of Survival|||Number
2689642|NCT01325207|Post-Hoc|Progression Free Survival (PRS) at 6 Months and at 12 Months in Treatment With Intrathecal Trastuzumab for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.|Progression Free Survival (PFS) will be measured from the time of treatment initiation until the first documentation of progression. To estimate the probability of PFS at 6 months and 12 months, Kaplan-Meier curves will be calculated and PFS at 6 months and 12 months will be determined from the progression-free survival curve. Progression will be defined as worsening clinical signs or development of new clinical symptoms that the Investigator feels can be attributed to Leptomeningeal disease.|At 6 and 12 months from start of treatment|Cohort results for this outcome measure were analyzed both combined and for patients treated at the MTD dose of 80mg IT as the objective was to determine preliminary data on PFS of patients with this drug combination.|||Probability of Survival|||Number
2689643|NCT01325207|Other Pre-specified|Define the CSF PK of IT Trastuzumab.|Patients may need a CSF flow study at the discretion of the treating principal investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed.|CSF analysis for cytology will be done every 2 weeks when CSF is obtained for PK and then every 4 weeks|||||||
2689644|NCT01325207|Primary|Best Response to IT Trastuzumab: Radiological, Cytological and Clinical in Treatment With Intrathecal Trastuzumab for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.|Best response will be assessed using a combination CSF cytology assessment, radiographic assessment and clinical function assessments. Best response will be defined as the best response seen during treatment as compared to baseline that is confirmed on subsequent response assessment.|Baseline then at 4 weeks, 8 weeks and then every 8 weeks +/- 3 days, until disease progression or toxicity,range of cycles completed 1-22 cycles where 1 cycle = 28 days.|All patients were assessed for response. Patients unable to be assessed were determined to have progressive disease and counted. Cohort results for this outcome measure were analysed combined and at the MTD of 80mg IT (Cohort 5 + phase II). The objective was to determine preliminary response data for this treatment combination.|||Participants|||Count of Participants
2689645|NCT01325207|Primary|Number of Dose Limiting Toxicities (DLT) of IT Trastuzumab in Sequential Cohorts of Escalating Doses for Patients With Leptomeningeal Metastases in HER2+ Breast Cancer.|"Patients will be treated using a standard 3+3 dose-escalation design for cohorts 1 and 2. This will be followed by an accelerated phase I for cohorts 3 and 4, and then a standard 3 + 3 for the 5th cohort. In the accelerated phase (cohorts 3 and 4), 1 patient will be enrolled per cohort; if a toxicity is seen in that patient then the cohort would be expanded to 6 patients to allow for 1/6 patients per cohort to have a dose limiting toxicity (DLT) before dose escalation. Cohort 5 will enroll a total of 6 patients regardless of the toxicity experienced in patient one. However, if 2 or more DLTs are observed in cohort 5, cohort 4 will be reopened to enroll of a total of 6 patients. Whatever dose is ultimately declared the MTD should have 6 patients total. If 1/6 DLTs are seen in cohort 5 that will be considered the MTD.~Dosing is as follows:~Cohort 1-10 mg IT Cohort 2-20 mg IT Cohort 3-40 mg IT Cohort 4-60 mg IT Cohort 5-80 mg IT"|From treatment initiation through the first 4 weeks of treatment.||||DLTs|||Number
2689646|NCT01325181|Secondary|Number of Participants With Adverse Event|number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events|12 months|||||||
2689651|NCT01325181|Primary|Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment|number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study|12 months|All study eyes were analyzed using intention to treat principle and the last observation forward method|||participants|||Number
2689652|NCT01325181|Secondary|Change From Baseline in logMAR BCVA|the changes from baseline in logMAR BCVA throughout the follow-up period|12 months|||||||
2689653|NCT01324999|Secondary|Number of Participants With Change in WHO Functional Class (WHO FC)|The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment.|Baseline, Week 24||||participants|||Number
2689654|NCT01324999|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline, Week 8, Week 16, Week 24||||units on a scale||Standard Deviation|Mean
2689655|NCT01324999|Secondary|Short Form-36 Global Score|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best).|Baseline, Week 8, Week 16, Week 24||||units on a scale||Standard Deviation|Mean
2689656|NCT01324999|Secondary|Brain Natriuretic Peptide Level||Baseline, Week 8, Week 16, Week 24||||pg/mL||Standard Deviation|Mean
2689657|NCT01324999|Secondary|Maximum Borg Dyspnea Score During 6 Minute Walk Test|The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea.|Baseline, Week 8, Week 16, Week 24|Only 6 of the 7 study completers performed 6 minute walk test through the end of the study.|||units on a scale||Standard Deviation|Mean
2689658|NCT01324999|Secondary|Oxygen Desaturation During 6 Minute Walk Test|Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test|Baseline, Week 24|Only 6 of the 7 study completers performed the 6 minute walk test through week 24|||oxygen saturation percentage points||Standard Deviation|Mean
2689659|NCT01324999|Secondary|Resting Oxygen Saturation|Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.|Baseline, Week 24|only 6 of the 7 study completers performed the 6 minute walk test through week 24.|||percent||Standard Deviation|Mean
2689660|NCT01324999|Primary|6 Minute Walk Distance||Baseline, Week 8, Week 16, Week 24|Only 6 of the 7 study completers performed 6 minute walk test through week 24|||meters||Standard Deviation|Mean
2689661|NCT01324947|Secondary|Time to Response Based on IMWG and Assessed by the Investigator|Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks|Includes those who had at least a partial response or better; Intent to Treat|||weeks||Full Range|Median
2689662|NCT01324947|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.|Intent to Treat population included all participants enrolled into the study|||weeks||95% Confidence Interval|Median
2689663|NCT01324947|Secondary|Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria|Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.|Includes those who had a partial response or better.|||weeks||95% Confidence Interval|Median
2689664|NCT01324947|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria|"Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG).~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.|Intent to Treat includes all participants enrolled|||weeks||95% Confidence Interval|Median
2689665|NCT01324947|Secondary|Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas."|From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.|Intent to Treat included all participants enrolled.|||weeks||95% Confidence Interval|Median
2700358|NCT01243320|Primary|Change in Carbon Dioxide Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
2689666|NCT01324947|Secondary|Number of Participants With Adverse Events and Type of Adverse Events|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:~Results in death;~Is life-threatening;~Requires or prolongs existing inpatient hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Constitutes an important medical event.~The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):~Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death"|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
2689667|NCT01324947|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following:~Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.~<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.~No increase in size or number of lytic bone lesions.~Disappearance of soft tissue plasmacytomas.~PR requires all of the following:~≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.~Reduction in 24-hour urinary light chain extraction by ≥90% or to <200 mg, maintained at least 42 days.~For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to treat population includes all participants enrolled.|||percentage of participants|||Number
2689668|NCT01324947|Primary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to Treat Population was defined as all enrolled participants.|||percentage of participants|||Number
2689669|NCT01324882|Primary|Intubation of Cecum|The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.|(day 1) Within time for performance of colonoscopy||||Participants|||Count of Participants
2689670|NCT01324882|Primary|Time to Intubate the Cecum|The time in seconds that it required to intubate the cecum as defined in our protocol.|The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over.||||seconds||Standard Deviation|Mean
2689671|NCT01324830|Secondary|Disease Control|Disease control was a best overall response of complete response, partial response or stable disease, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment. Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients.|From the start of treatment to the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013.|TS|||Participants|||Number
2689672|NCT01324830|Secondary|Objective Response|"Objective response was a best overall response of complete or partial response, recorded between the start of treatment and the earliest of disease progression, death, or the end of treatment.~Some patients excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients."|From the start of treatment and the earliest of disease progression, death, or the end of treatment. The data cut-off date is 29-Nov-2013.|TS|||Participants|||Number
2689673|NCT01324830|Secondary|Best Overall Response|Best overall response was the best response a patient experienced during their time on study from the start of treatment until: disease progression, the last evaluable assessment in the absence of progression, or the start of subsequent anti-cancer therapy. Death was not considered as progressive disease when determining best overall response; patients who died prior to an evaluable imaging assessment were reported as not evaluable. Some patients were excluded from TS as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients.|From the start of treatment until the last evaluable assessment. The data cut-off date is 29-Nov-2013|TS|||Participants|||Number
2689674|NCT01324830|Primary|Percentage of Patients With Dose Limiting Toxicity During the First Treatment Cycle in Phase Ia Part of the Study|"Occurrence of dose limiting toxicity (DLT) during the first treatment cycle for the treatment Schedules A and B.~Some patients excluded from Treated Set (TS) as they were not evaluable for determination of maximum tolerated dose. Thus the number of evaluable TS patients are not the same as the number of original TS patients."|3 weeks|Treated Set (TS)|||Percentage of participants|||Number
2689704|NCT01324453|Primary|Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)|Infarct size was quantified by delayed, contrast-enhanced MRI|Day 3-5 post-PCI|There were 12 patients whose MRI data were not usable, including 6 in the post conditioning + PCI group and 6 in the standard PCI group.|||ml||Inter-Quartile Range|Median
2689675|NCT01324700|Secondary|Hamilton Rating Scale for Depression (HRSD)|The patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52.|12 weeks||||units on a scale||Standard Deviation|Mean
2689676|NCT01324700|Primary|Asthma Control Questionnaire (ACQ)|The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|12 weeks||||units on a scale||Standard Deviation|Mean
2689677|NCT01324687|Secondary|Cost of Care|Comparison of cost of care between intervention and control groups.|Up to 36 months|The cost data was not available from the Finance Office from Rochester General Hospital or Thompson Hospital so this analysis was not performed.||||||
2689678|NCT01324687|Primary|Emergency Department Use|Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.|Up to 42 months||||Emergency dept use rate per person-month|||Number
2689679|NCT01324622|Secondary|Extent of Spinal Canal/Cord Decompression||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689680|NCT01324622|Secondary|Sagittal Canal Diameter||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689681|NCT01324622|Secondary|Range of Motion||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689682|NCT01324622|Secondary|Sensory Deficit||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689683|NCT01324622|Secondary|Reflex Evaluation||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689684|NCT01324622|Secondary|Motor Deficit||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689685|NCT01324622|Secondary|Quality of Life Improvement Using the SF-12 Scale||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689686|NCT01324622|Secondary|Functional Improvement Using the Neck Disability Index (NDI)||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689687|NCT01324622|Secondary|Pain Scores on the Visual Analog Scale||Up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
2689688|NCT01324622|Primary|Incidence of Surgical Interventions|Success defined as a lack of revision, removal or addition of supplemental fixation.|up to 24 months||||participants w/o surgical intervention|||Number
2689689|NCT01324622|Primary|Sagittal Angle Success|Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph|12 months|Number of participants with radiographic data available at 12 month visit|||participants with ≤15° sagittal angle|||Number
2689690|NCT01324622|Primary|Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate|Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))*100|12 months|Number of participants with 12-month follow-up data.|||participants with mJOA Recovery Rate ≥0|||Number
2689691|NCT01324570|Primary|Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)|The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.|Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit|The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.|||Liters||95% Confidence Interval|Mean
2689692|NCT01324570|Secondary|Parent/Caregiver-assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The PGIC score was summarized using the number and percent of patients in each of the 7 possible response categories overall and by age group. PGIC was assessed by the parent/caregiver at the end of treatment visit or early discontinuation visit.|End of treatment (week 24) or early discontinuation visit|The full analysis population (FAP) (N=40) was the group of patients who received at least 1 dose of the study drug during the study; however data was provided for only 38 patients for this outcome measure.|||Participants|||Count of Participants
2689740|NCT01324271|Secondary|Number of Retained (TTDS-placed) Tubes|Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.|14 days|Total in-office (IO) subjects.|||tubes|Participants||Number
2694956|NCT01283282|Secondary|Inflammatory Marker CD40 Ligand|CD40 ligand levels were measured. The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B.|Week 12||||pg/mL||Standard Error|Mean
2689693|NCT01324570|Secondary|Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive|"Pain right now was assessed using a 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked as no pain and the other marked as pain as bad as it could be. The patient was asked to make a mark on that line indicating his or her level of pain. Pain right now score was defined as the distance (in mm) from the no pain end to the patient's mark; 0=no pain and bigger numbers indicate more pain. For screening to week 4, pain right now was assessed 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.~For weeks 6-24, pain right now was measured once a week at approximately 8 PM."|Up to 24 weeks|The FAP was the group of patients who received at least 1 dose of the study drug during the study.|||units on a scale||Standard Error|Mean
2689694|NCT01324570|Secondary|Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive|"Pain right now was assessed using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with no hurt at the far left and hurts worst at the far right; the intensities are scored as 0, 2, 4, 6, 8, or 10. A score of 0=no pain, and 10=very much pain. For screening to week 4, pain right now was assessed at 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline score was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.~The study measured pain right now for weeks 6-24 once a week at approximately 8 PM while on treatment; however, no patients in this age group were treated beyond week 12."|Up to 24 weeks|The full analysis population (FAP) was the group of patients who received at least 1 dose of the study drug during the study.|||units on a scale||Standard Error|Mean
2689695|NCT01324570|Primary|Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)|The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.|Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit|The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.|||Liters/hour||95% Confidence Interval|Mean
2689696|NCT01324570|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale [UMSS]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.|Up to 28 weeks|The safety population (N=41) was the group of patients who received at least 1 dose of study drug during the study.|||Participants|||Count of Participants
2689697|NCT01324453|Secondary|Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl|LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.|baseline|There were 4 patients who did not have an LVESV measurement done, including 2 in the post conditioning + PCI group and 2 in the standard PCI group.|||mL||Inter-Quartile Range|Median
2689698|NCT01324453|Secondary|Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl|LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole.|baseline|There were 4 patients who did not have an LVEDV measurement done, including 2 in the post conditioning + PCI group and 2 in the standard PCI group.|||mL||Inter-Quartile Range|Median
2689699|NCT01324453|Secondary|Infarct Size by Peak Creatine Kinase (CK)||over first 72 hours post PCI|There was 1 patient who did not have a CK lab test done in the standard PCI group.|||IU/L||Inter-Quartile Range|Median
2689700|NCT01324453|Secondary|Infarct Size by Peak Troponin||over first 72 hour post PCI|There were 31 patients who did not have a troponin drawn within the specified study protocol window, including 10 in the post conditioning + PCI group and 21 in the standard PCI group.|||ng/ml||Inter-Quartile Range|Median
2689701|NCT01324453|Secondary|Global Left Ventricular Ejection Fraction||baseline||||Percent||Standard Deviation|Mean
2689702|NCT01324453|Primary|Micro Vascular Obstruction (MVO) on Baseline cMRI|High T1 imaging was utilized for the determination of the presence or absence of MVO.|Day 3-5 post-PCI|There were 8 patients in which were unable to determine the presence or absence of MVO, including 4 in the post conditioning + PCI group and 4 in the standard PCI group.|||Participants|||Count of Participants
2689703|NCT01324453|Primary|Myocardial Salvage Index (MSI) on Baseline cMRI|The myocardial salvage index (MSI) was calculated using the formula: MSI = (AAR — Infarct size) / AAR X 100 % where quantitative estimation of myocardium at risk (AAR) was measured as the hyperintense region on T2- weighted imaging. Measurements were performed using the QMass software package (Medis mc, Raleigh NC) by a single investigator who was blinded to treatment. The endocardial and epicardial borders were manually identified and the regions of interest (edema or scar) were automated as 2 standard deviations above the mean density of the myocardium.|Day 3-5 post-PCI|There were 18 patients we were unable to obtain myocardial salvage indexes for, including 10 in the post conditioning + PCI group and 8 in the standard PCI group.|||(%)||Inter-Quartile Range|Median
2689705|NCT01324440|Primary|Number of Vaccine-related Serious Adverse Experiences|"Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol:~A serious adverse event (SAE) is any AE that:~results in death,~is life threatening,~results in a persistent or significant disability/incapacity,~results in or prolongs an existing inpatient hospitalization,~is a congenital anomaly/birth defect,~is a cancer,~is an overdose,~or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above."|Up to Day 360 postvaccination|Any subject who received clinical material and had at least 1 day of safety follow-up was included in the safety summary.|||participants|||Number
2689706|NCT01324440|Primary|Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)|"Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.~The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline."|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.|||ratio of IgG titer at Day 14 to baseline||95% Confidence Interval|Geometric Mean
2689707|NCT01324440|Primary|Geometric Mean Antibody Concentrations (GMC)|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.|||mcg/mL||95% Confidence Interval|Geometric Mean
2689708|NCT01324440|Primary|Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.|||participants|||Number
2689709|NCT01324401|Secondary|Desensitization|The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment|at least 36 months||||Participants|||Count of Participants
2689710|NCT01324401|Primary|Tolerance or Sustained Unresponsiveness|The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance|at least 36 months||||Participants|||Count of Participants
2689711|NCT01324388|Primary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM blood pressure data.|||millimeter of mercury (mm Hg)||Standard Deviation|Mean
2689712|NCT01324388|Primary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM heart rate data.|||beats per minute (bpm)||Standard Deviation|Mean
2689713|NCT01324388|Primary|Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril||Day -1, Day 3, Day 24 in Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril Cmax data.|||(nanograms per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
2689714|NCT01324388|Secondary|Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2689715|NCT01324388|Secondary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol AUC data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2689716|NCT01324388|Secondary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM blood pressure data.|||millimeter of mercury (mm Hg)||Standard Deviation|Mean
2689717|NCT01324388|Secondary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM heart rate data.|||beats per minute (bpm)||Standard Deviation|Mean
2689718|NCT01324388|Primary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril AUC data.|||(nanograms*hours/milliliter)/milligram||Geometric Coefficient of Variation|Geometric Mean
2689719|NCT01324349|Secondary|Number of Subjects With Treatment-emergent Adverse Events||Up to 30 days post surgery.|All treated subjects are included in the Safety population.|||Participants|||Number
2689720|NCT01324349|Secondary|Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil).|||Participants|||Number
2689721|NCT01324349|Primary|Median Time to Achieve Hemostasis Following Application of Study Treatment.|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®).|||Minutes||Full Range|Median
2689722|NCT01324323|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after the last treatment)|The safety population included all subjects who received at least 1 dose of study drug.|||participants|||Number
2689723|NCT01324323|Primary|Apparent Total Volume of Distribution (Vz).|Apparent total volume of distribution (Vz) was calculated as [(CL)/λz] for Romidepsin and co-administered with Rifampin.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population was to consist of all participants who received at least 1 dose of study drug and had evaluable PK profiles.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2689724|NCT01324323|Primary|Clearance (CL): Apparent Total Plasma Clearance.|The apparent total plasma clearance (CL) was calculated as [Dose/AUC0-∞] for Romidepsin alone and co-administered with rifampin plasma concentrations.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2689725|NCT01324323|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|The terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]. This was only calculated when a reliable estimate for λz could be obtained.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||hours||Geometric Coefficient of Variation|Geometric Mean
2689726|NCT01324323|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Time to maximum observed plasma concentration (Tmax) was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||hours||Full Range|Median
2689727|NCT01324323|Primary|Maximum Observed Plasma Concentration (Cmax)of Romidepsin|Maximum observed plasma concentration (Cmax)was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2689728|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞).|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz]. λz is the apparent terminal rate constant. No AUC extrapolation was performed with unreliable λz. If the percentage of AUC extrapolated is ≥ 25%, AUC0-∞ will not be reported.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2689729|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin|Individual and mean romidepsin plasma concentrations by treatment and scheduled time data were collected. AUC0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 and Day 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2689730|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2689750|NCT01323972|Secondary|Number of Subjects With Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 8 months post-dose 1|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2689731|NCT01324310|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|All 15 subjects in the safety population received at least 1 dose of romidepsin. AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after last treatment)|The safety population consisted of all participants who received at least 1 dose of study drug. The Day 8 analysis population included 13 participants because two participants discontinued from the study prior to Day 8 (one due to an AE, the other due to disease progression).|||participants|||Number
2689732|NCT01324310|Primary|Apparent Total Volume of Distribution (Vz)|Vz: apparent total volume of distribution, calculated as [(CL)/λz].|Days 1 and 8, At 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2689733|NCT01324310|Primary|Apparent Total Plasma Clearance (CL)|Apparent total plasma clearance, (CL) calculated as [Dose/AUC 0-∞].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2689734|NCT01324310|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|Terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]|Days 1 and 8; at 0 (pre-dose),1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||hours||Geometric Coefficient of Variation|Geometric Mean
2689735|NCT01324310|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Tmax: time to maximum observed Tmax, obtained directly from the observed concentration versus time data|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||hours||90% Confidence Interval|Median
2689736|NCT01324310|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: maximum observed plasma concentration, obtained directly from the observed concentration versus time data; for Cmax, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2689737|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2689738|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC 0-24)|AUC 0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing; for AUC 0-24 an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion|Assess the influence of multiple doses of ketoconazole on the pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2689739|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. For AUC0-t, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% CI between romidepsin alone and romidepsin in the presence to ketoconazole.|Days 1 and 8; at 0 (pre-dose) 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assessment on the influence of multiple doses of ketoconazole on the Pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2689741|NCT01324271|Primary|Percentage of Tubes Successfully Placed Using a TTDS Device|"Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.~A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with tube. Tube is the outcome of the device use."|Day 0|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting|||percentage of devices|Participants|95% Confidence Interval|Number
2689742|NCT01324271|Primary|Percentage of Subjects With In-office Tube Placement Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.|Day 0||||Percentage of Subjects||95% Confidence Interval|Number
2689743|NCT01324128|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12|Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.|Week 12 post Baseline|For the Secondary Outcome, data from the Per Protocol Set (PPS) was used. The PPS consists of all subjects who had completed the analysis dose titration period (baseline to Week 12), had at least 1 evaluable serum phosphorus result at or after Week 12, and had no major protocol deviations.|||mg/dL||Standard Error|Least Squares Mean
2689744|NCT01324128|Primary|Change in Serum Phosphorus Levels From Week 24 to Week 27|Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27|Week 24, Week 27|For the Primary Outcome, data from the Primary Efficacy Set (PES) was used. The PES consists of subjects who were randomized to Stage 2 and received at least 1 dose of study medication during Stage 2 and had at least 1 post-baseline (Stage 2) efficacy assessment in Stage 2.|||mg/dL||Standard Deviation|Least Squares Mean
2689745|NCT01324102|Primary|Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.|The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).|Primary outcome is measured at baseline and after the 8 week yoga intervention.|This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment.|||units on a scale||Full Range|Mean
2689746|NCT01324024|Secondary|NYU Paragraph Recall Task|Subjects hear 2 brief narratives, each containing 19-21 informational bits, and are asked to recall as many details as possible immediately after hearing each paragraph (A and B) and again following a 30 minute delay. Subjects receive credit for each informational bit recalled verbatim. Different paragraphs were read at each assessment. The maximum number of correct responses for paragraph A is 19 and the maximum number of correct responses for paragraph B is 21.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.|||units on a scale||Standard Deviation|Mean
2689747|NCT01324024|Secondary|Penn Continuous Performance Test|The Penn Continuous Performance Test is a measure of visual attention and vigilance. In this task, a series of red vertical and horizontal lines flash in a digital numeric frame. The participant must press the spacebar whenever the lines form complete numbers or complete letters. The minimum to maximum score range for this task is 0-60 correct responses, with 60 being a perfect score. This data presented in the outcome measure table reflects the total number of correct responses.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.|||units on a scale||Standard Deviation|Mean
2689748|NCT01324024|Primary|Brown Attention Deficit Disorder Scale (BADDS)|The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|Of the 55 participants who were consented for screening, 20 were excluded. Of the remaining 35 subjects, 32 completed both active and placebo treatment trials. The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms. 35 total participant data was analyzed for the baseline arm.|||units on a scale||Standard Deviation|Mean
2689749|NCT01323998|Primary|Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis|The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.|4 years|Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.|||participants|||Number
2700359|NCT01243320|Primary|Change in Chloride Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
2689751|NCT01323972|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2689752|NCT01323972|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
2689753|NCT01323972|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
2689754|NCT01323972|Secondary|Anti-hepatitis B (Anti-HB) Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|One month post-dose 3 (Month 3)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2689755|NCT01323972|Primary|Anti-Circumsporozoite (Anti-CS) Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.|One month post-dose 3 (Month 3)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2689756|NCT01323959|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 0 - Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.|||Subjects|||Number
2689757|NCT01323959|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.|||Subjects|||Number
2689758|NCT01323959|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-Day 3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.|||Subjects|||Number
2689759|NCT01323959|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-Day 3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.|||Subjects|||Number
2689760|NCT01323959|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2689761|NCT01323959|Secondary|Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2689762|NCT01323959|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2689763|NCT01323959|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off|Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2689764|NCT01323959|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2689765|NCT01323959|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2689766|NCT01323959|Primary|Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2689767|NCT01323959|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2689768|NCT01323959|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies|Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2689769|NCT01323959|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2689770|NCT01323959|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2689771|NCT01323959|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2689772|NCT01323959|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2700360|NCT01243320|Primary|Change in Potassium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
2689773|NCT01323946|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|During the entire study period (from Day 0 to 364)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689774|NCT01323946|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Grade 3 was defined as an AE which prevented normal, everyday activities. Related was defined as an AE assessed by the investigator as causally related to the study vaccination."|During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689775|NCT01323946|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Grade 3 was defined as an AE which prevented normal, everyday activities. Related was defined as an AE assessed by the investigator as causally related to the study vaccination."|During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689776|NCT01323946|Secondary|Number of Subjects With Potential Immune-mediated Disease (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from day 0 to Day 364)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689777|NCT01323946|Secondary|Number of Subjects With Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (from Day 0 to Day 364)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689778|NCT01323946|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689779|NCT01323946|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.|During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689780|NCT01323946|Secondary|Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)|At Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689781|NCT01323946|Secondary|Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)|At Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689836|NCT01323647|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (Day 0 to Month 1).|The Total Cohort included all subjects enrolled in the study.|||Participants|||Count of Participants
2689782|NCT01323946|Secondary|Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain|Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)|At Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689783|NCT01323946|Secondary|Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|Titers were presented as geometric mean titers (GMTs).|Day 0, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689784|NCT01323946|Secondary|Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain|Titers were presented as geometric mean titers (GMTs).|Day 0, Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689785|NCT01323946|Secondary|Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.|Day 0, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689786|NCT01323946|Secondary|Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain|A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28|Day 0, Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689787|NCT01323946|Secondary|Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.|At Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689788|NCT01323946|Secondary|Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.|At Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689789|NCT01323946|Secondary|Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain|Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.|Day 182 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689790|NCT01323946|Secondary|Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain|Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).|At Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689791|NCT01323946|Secondary|Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.|Day 0, Day 182 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0 and Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689792|NCT01323946|Secondary|Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain|A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.|At Day 0, Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689793|NCT01323946|Secondary|Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.|At Day 182 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689794|NCT01323946|Secondary|Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain|A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689795|NCT01323946|Secondary|Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.|At Day 0, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689796|NCT01323946|Secondary|Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005|A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.|At Day 0, Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689797|NCT01323946|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.|At Day 0, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689798|NCT01323946|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.|At Day 0, Day 42, Day 182, Day 192 and Day 364|The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.|||Titer||95% Confidence Interval|Geometric Mean
2689799|NCT01323946|Primary|Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain|A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.|At Day 192|The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689800|NCT01323946|Primary|Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain|Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).|At Day 192|The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.|||Titers||95% Confidence Interval|Geometric Mean
2689801|NCT01323946|Primary|Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain|A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.|At Day 192|The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.|||Participants|||Count of Participants
2689802|NCT01323920|Secondary|The Cumulative Incidence of Chronic GVHD Requiring Systemic Immune Suppression up to 1 Year After Stem Cell Infusion||1 year|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percentage of participants|||Number
2689803|NCT01323920|Secondary|The Non-relapse Mortality, Progression-free and Overall Survival up to 1 Year After Stem Cell Infusion|Progression free and overall survival by 1 year after stem cell infusion will be assessed using the method of Kaplan and Meier. Progression-free survival will be defined as the time from stem cell infusion to the time of disease progression or death from any cause. Overall survival will be defined as the time from stem cell infusion to the time to death from any cause. Patients will be censored at the time last documented alive. Cumulative incidence and Kaplan-Meier curves will be constructed as appropriate. Progression is defined per clinical presentation, not protocol specified, and vary per disease, e.g. blasts in bone marrow or peripheral blood for AML/MDS; lymphoma + on PET/CT re-staging etc.|1 year|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percent of participants|||Number
2689804|NCT01323920|Secondary|The Percentage Donor Engraftment up to Day 30 Post Stem Cell Infusion|To assess the percentage donor engraftment up to day 30 post stem cell infusion, defined as the first of 3 consecutive days tested of documented absolute netrophil count (ANC) >/= 500 cells/u/L|Day 30|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percentage of participants|||Number
2689805|NCT01323920|Primary|The Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion|The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 100 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.|Day 100|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percentage of participants|||Number
2689806|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure|||ng.hr/mL||95% Confidence Interval|Geometric Mean
2689807|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure|||ng.hr/mL||95% Confidence Interval|Geometric Mean
2689808|NCT01323855|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure|||ng.hr/mL||95% Confidence Interval|Geometric Mean
2689809|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2689810|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2689811|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue - First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||hours||95% Confidence Interval|Median
2689812|NCT01323790|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of SBMs/week||Standard Error|Least Squares Mean
2689813|NCT01323790|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|"A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: Did you feel like your bowels were completely empty after the bowel movement? Patients provided a yes or a no response. A positive change from baseline indicates improvement."|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Percent days/week||Standard Error|Least Squares Mean
2689814|NCT01323790|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
2689815|NCT01323790|Secondary|Change From Baseline in Degree of Straining|"A single-item straining question was asked via the eDiary: How much did you strain during your bowel movement? Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement."|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
2689816|NCT01323790|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of Days||Standard Error|Least Squares Mean
2689817|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Hours||95% Confidence Interval|Median
2689818|NCT01323790|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.|||Number of patients|||Number
2689819|NCT01323790|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of patients|||Number
2689820|NCT01323777|Primary|Monocular Uncorrected Near Decimal VA|VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2689821|NCT01323777|Primary|Monocular Uncorrected Distance Decimal Visual Acuity|Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2689822|NCT01323673|Secondary|Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15|On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Percent change in scores on a scale||Standard Deviation|Mean
2689823|NCT01323673|Secondary|Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689858|NCT01323517|Secondary|To Define the Immunologic Events and Signatures at the Tumor Site and in the Periphery That Corresponds to Response to Ipilimumab.|Summaries of antibody response, comparison of pretreatment with post-ipilimumab and end of treatment will be assessed for percent of CD4, CD8, and CD68 positive cells|2 years||||percent of positive cells||Full Range|Mean
2700361|NCT01243320|Primary|Change in Sodium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
2689824|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689825|NCT01323673|Secondary|Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689826|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689827|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689828|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689829|NCT01323673|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
2689830|NCT01323660|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689861|NCT01323517|Primary|Progression Free Survival at One Year.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year||||percentage of participants PFS at 1 year|||Number
2689831|NCT01323660|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 1.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689832|NCT01323660|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689833|NCT01323660|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689834|NCT01323660|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689835|NCT01323660|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Seconds||Standard Error|Least Squares Mean
2690107|NCT01319851|Secondary|Number of Participants That Expressed Successful Neutrophil Engraftment|Neutrophil engraftment was assessed with absolute neutrophils >500*10^8/kg by 100 days post transplant. Neutrophils were counted by performing a complete blood cell count (CBC).|Day 100 post-transplant||||participants|||Number
2689837|NCT01323647|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.|Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.|The Total Vaccinated cohort included all subjects, with booster dose administration documented and for whom data were available.|||Participants|||Count of Participants
2689838|NCT01323647|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) >39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort included all subjects, with booster dose administration documented, for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2689839|NCT01323647|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort included all subjects, with booster dose administration documented, for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2689840|NCT01323647|Primary|Antibody Titers Against Poliovirus Type 1, 2 and 3.|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.|Before booster vaccination.|The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint|||Titers||95% Confidence Interval|Geometric Mean
2689841|NCT01323647|Primary|Antibody Titers Against Poliovirus Type 1, 2 and 3|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
2689842|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.|Before booster vaccination.|The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint|||Participants|||Count of Participants
2689843|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2689844|NCT01323634|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
2689845|NCT01323634|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2689846|NCT01323621|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Baseline and Day 1|ITT Population|||Minutes||Full Range|Median
2689859|NCT01323517|Secondary|To Determine Response Rates of Combination Therapy. Tumor Assessment Will be Measured by the Immune Related Response Criteria (irRC).|"Progression free survival, from time of ILI, will be determined by measuring the index lesions, non-index lesions, and new lesions as described below. Patients with deep lesions will have repeat CT Scan evaluation to quantitate the lesions.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|2 years||||Participants|||Count of Participants
2689847|NCT01323621|Primary|Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
2689848|NCT01323595|Secondary|Number of Participants With Bleeding Complications|We will record whether there are any bleeding complications associated with treatment after surgery.|7 days after surgery||||Participants|||Count of Participants
2689849|NCT01323595|Primary|Level of Pain|Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale, ranging from 0 to 10, in which 0= no pain, 10=worst pain ever. Patients are asked to rate their pain up to four times a day during the post-operative period. Pain scores from each post-operative day each day will be averaged and reported as the pain score for that day.|1 week after surgery||||Analog pain scale||Standard Deviation|Mean
2689850|NCT01323582|Secondary|Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references.~This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change."|Baseline and end of treatment period||||units on a scale||Standard Deviation|Median
2689851|NCT01323582|Secondary|Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.~Negative value reflects this change."|Baseline and end of treatment period|One subject did not complete this part of analysis.|||units on a scale||Standard Deviation|Mean
2689852|NCT01323582|Secondary|Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|at baseline before initiation of the treatment and after completion of each treatment period.||||minutes||Standard Deviation|Mean
2689853|NCT01323582|Secondary|Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|Baseline and end of treatment period||||Minutes||Standard Deviation|Mean
2689854|NCT01323582|Secondary|TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)|This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)||||Minutes||Standard Deviation|Mean
2689855|NCT01323582|Secondary|NDI Score|"Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).~For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.~Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)||||units on a scale||Standard Deviation|Median
2689856|NCT01323582|Primary|Gastroparesis Cardinal Symptom Index (GCSI) Score|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms.~Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)|One subject did not complete this part of analysis.|||units on a scale||Standard Deviation|Mean
2689857|NCT01323582|Primary|Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)||||Minutes||Standard Deviation|Mean
2689862|NCT01323478|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.|Up to 52 weeks|Suicidal Ideation and Behaviour Based on C-SSRS Scores by Columbia Classification Algorithm for Suicide Assessment (C-CASA) - APTS|||participants|||Number
2689863|NCT01323478|Secondary|ASEX Total Score After 52 Weeks of Treatment|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Week 52|APTS, OC|||units on a scale||Standard Error|Mean
2689864|NCT01323478|Secondary|SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 52|FAS, OC|||units on a scale||Standard Deviation|Mean
2689865|NCT01323478|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Baseline and Week 52|FAS, OC|||percentage of patients|||Number
2689866|NCT01323478|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Baseline from lead-in study 13267A (NCT01140906) and Week 52|FAS, OC|||percentage of patients|||Number
2689867|NCT01323478|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS, OC|||units on a scale||Standard Deviation|Mean
2689868|NCT01323478|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS, OC|||units on a scale||Standard Deviation|Mean
2689869|NCT01323478|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|full-analysis set (FAS), observed cases (OC)|||units on a scale||Standard Deviation|Mean
2689870|NCT01323478|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
2689871|NCT01323478|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|all-patients-treated set (APTS)|||participants|||Number
2689872|NCT01323387|Secondary|Oswestry Disability Index (ODI) Summary|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible|Baseline and 24 Months||||Units on a scale||Standard Deviation|Mean
2689873|NCT01323387|Secondary|SF-12 Mental Composite Score (MCS) Summary|The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months||||Units on a scale||Standard Deviation|Mean
2689874|NCT01323387|Secondary|SF-12 Physical Composite Score (PCS) Summary|The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months||||Units on a scale||Standard Deviation|Mean
2689875|NCT01323387|Secondary|Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline|The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months||||Participants|||Count of Participants
2689876|NCT01323387|Secondary|Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline|The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible|24 Months||||Participants|||Count of Participants
2689877|NCT01323387|Secondary|Pain Scores on the Numeric Rating Scale (NRS)|The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)|Baseline and 24 Months||||units on a scale||Standard Deviation|Mean
2690285|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 7 (Maintenance Period Month 3)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
2689878|NCT01323387|Secondary|Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.|Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.|24 Months||||Participants|||Count of Participants
2689879|NCT01323387|Primary|Number of Subjects With Successful Radiographic Fusion|CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.|24 Months||||Participants|||Count of Participants
2689880|NCT01323270|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|Summary was performed for participants as per vaccine administration.|||percentage of participants|||Number
2689881|NCT01323270|Other Pre-specified|Geometric Mean Fold-Rise (GMFR) for IgG||Before Vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.||||||
2689882|NCT01323270|Other Pre-specified|Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)||Before vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.||||||
2689883|NCT01323270|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level||1 month after Vaccination 3||||percentage of participants|||Number
2689884|NCT01323270|Secondary|Geometric Mean Titer (GMT) for Poliomyelitis Antigens||1 month after Vaccination 1||||titer||95% Confidence Interval|Geometric Mean
2689885|NCT01323270|Secondary|GMC for Acellular Pertussis Antigens|Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)|1 month after Vaccination 1||||EU/mL||95% Confidence Interval|Geometric Mean
2689886|NCT01323270|Secondary|Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens||1 month after Vaccination 1||||International Units per milliliter||95% Confidence Interval|Geometric Mean
2689887|NCT01323270|Primary|Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen||1 month after Vaccination 1||||percentage of participants|||Number
2689888|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores|"Q-LES-Q-SF is a 16-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 16 items. The raw total score is transformed into a percentage maximum possible score using the following formula:(raw total score −minimum score) / (maximum possible raw score −minimum score). The minimum raw score on the Q-LES-Q-SF is 16 (worst), and the maximum score is 80 (best). A higher score indicates a better quality of life."|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Standard Deviation|Mean
2689889|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales-Self Report: Screening Version (CAARS-S:SV) Score|CAARS-S:SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-S:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Standard Deviation|Mean
2689890|NCT01323192|Secondary|Clinical Global Impression of Change (CGI-C) Scores|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Full Range|Median
2689891|NCT01323192|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Full Range|Median
2689892|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O: SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment.|||Scores on a scale||Standard Deviation|Mean
2689995|NCT01321710|Primary|Maternal Sleep Quantity (Objective)|Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.|1-month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.|||hours||Standard Deviation|Mean
2689893|NCT01323192|Primary|Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Standard Deviation|Mean
2689894|NCT01323153|Secondary|Safety: Incidence of Adverse Events||24 weeks|||||||
2689895|NCT01323153|Secondary|Percent Change From Baseline in Apolipoprotein Levels||20 weeks|||||||
2689896|NCT01323153|Secondary|Percent Change From Baseline in Lipoprotein Levels||20 weeks|||||||
2689897|NCT01323153|Secondary|Percent Change From Baseline in Blood Lipid Levels||20 weeks|||||||
2689898|NCT01323153|Secondary|Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment||20 weeks|||||||
2689899|NCT01323153|Secondary|Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971||4 weeks|||||||
2689900|NCT01323153|Primary|Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment||4 weeks||||Percentage raise in HDL-C Levels||Standard Error|Least Squares Mean
2689901|NCT01323140|Primary|Percent of Subjects With Testosterone Levels in the Normal Range.|Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (>= 300 ng/dL to <= 1030 ng/dL), at least 85% of subjects with Cmax <= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax >= 2500 ng/dL.|Day 29/30||||percentage of participants||95% Confidence Interval|Number
2689902|NCT01323010|Secondary|Admission Rates in Patients With the Arg16Gly Polymorphisms|Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes).|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|The sequencing of the beta-2 adrenergic receptor gene was performed in a subset of 60 patients, in the other samples these analysis were not feasible due to hemolysis.|||participants|||Number
2689903|NCT01323010|Secondary|Admission Rates in Patients With and Without Rhinovirus Detect|Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.|||percentage of participants|||Number
2689904|NCT01323010|Secondary|Admission Rates in Patients With and Without Any Virus Detected|Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.|||percentage of participants|||Number
2689905|NCT01323010|Secondary|Lengths of Stay in the Emergency Room|lengths of stay in the emergency room for discharged patients|one to four hours||||hours||Inter-Quartile Range|Median
2689906|NCT01323010|Secondary|Electrocardiogram at Discharge or Hospital Admission|Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|No electrocardiographic abnormalities were detected in both groups.|||participants with ECG abnormalities|||Number
2689907|NCT01323010|Secondary|Electrocardiogram One Hour Post-treatment.|Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.|One hour post-treatment|No electrocardiographic abnormalities were detected im both groups|||participants with ECG abnormalities|||Number
2689908|NCT01323010|Secondary|Changes in Heart Rate at Discharge or Hospital Admission|Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)||||beats per minute||Standard Error|Mean
2689909|NCT01323010|Secondary|Changes in Heart Rate After One Hour|Change in heart rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline||||beats per minute||Standard Error|Mean
2689910|NCT01323010|Secondary|Changes in Pulse Oximetry at Discharge or Hospital Admission.|Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.||||percentage of oxygen saturation||Standard Deviation|Mean
2689911|NCT01323010|Secondary|Change in Pulse Oximetry One Hour Post-treatment|Change in pulse oximetry one hour post-treatment in comparison with baseline|One hour post-treatment in comparison with baseline||||percentage of oxygen saturation||Standard Error|Mean
2689912|NCT01323010|Secondary|Changes in Respiratory Rate at at Discharge or Hospital Admission.|Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.||||breaths per minute||Standard Error|Mean
2689996|NCT01321697|Primary|Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.||at time of surgery|Data were not collected/analyzed due to study termination.||||||
2690361|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2689913|NCT01323010|Secondary|Changes in Bicarbonate Serum Levels|Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain bicarbonate serum levels from 42 patients in the study group and 37 in the control group (in the other samples, this analysis was not feasible due to the long time to transport the samples to the laboratory in one of our centers).|||mmol/L||Standard Error|Mean
2689914|NCT01323010|Secondary|Changes in Potassium Serum Levels|Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain potassium serum levels from 54 patients in the study group and 56 in the control group (in the other samples, this analysis was not feasible due to hemolysis).|||mEq/L||Standard Error|Mean
2689915|NCT01323010|Secondary|Changes in PRAM Score at Discharge or Hospital Admission|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.~The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.~We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline).~The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).~minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0~minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1"|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.||||units on a scale||Inter-Quartile Range|Median
2689916|NCT01323010|Secondary|Need for Additional Therapies|The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|no patients received magnesium sulphate or intravenous albuterol in both groups|||participants|||Number
2689917|NCT01323010|Secondary|Changes in Respiratory Rate After One Hour|Change in respiratory rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline||||breaths per minute||Standard Error|Mean
2689918|NCT01323010|Secondary|Electrocardiogram at Baseline|Electrocardiogram performed at baseline|at baseline|no electrocardiopraphic abnormalities were detected in both groups|||participants with ECG abnormalities|||Number
2689919|NCT01323010|Secondary|Changes in Glucose Serum Levels|Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain glucose serum levels from 57 patients in the study group and 55 in the control group (in the other samples, this analysis was not feasible due to hemolysis).|||mg/dL||Standard Error|Mean
2689920|NCT01323010|Secondary|Albuterol Determination in the Plasma|Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|It was possible to obtain albuterol plasma levels from 52 patients in the study group and 51 in the control group (in the other samples, this analysis was not feasible due to hemolysis).|||ng/ml||Inter-Quartile Range|Median
2689921|NCT01323010|Secondary|Change in PRAM Score After One Hour|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline.~The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.~We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline).~The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).~minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0~minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0"|One hour post-treatment||||units on a scale||Inter-Quartile Range|Mean
2689922|NCT01323010|Secondary|Forced Expiratory Volume in the First Second|Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly.|One hour post-treatment in comparison with baseline||||percentage of predicted||Standard Deviation|Mean
2689923|NCT01323010|Primary|Hospital Admission|Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)|Starting at 4 hours post-treatment||||participants|||Number
2689924|NCT01322971|Secondary|Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)||up to 2 years|No data were collected for this outcome||||||
2689925|NCT01322971|Secondary|Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)||up to 2 years|No data were collected for this outcome||||||
2689926|NCT01322971|Secondary|Pregnancy Rate (Pregnancy Visible on Ultrasound)||up to 2 years|No data were collected for this outcome||||||
2689927|NCT01322971|Primary|Biochemical Pregnancy Rate (Positive Pregnancy Test)|Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test|up to 2 years|No data were collected for this outcome||||||
2689928|NCT01322945|Secondary|Test-retest Reliability of the ASK Nasal Inventory|First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.|90 days and 120 days post surgery||||Correlation Coefficient|||Number
2700362|NCT01243320|Secondary|Mean Change in Heart Rate|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||bpm||95% Confidence Interval|Mean
2689929|NCT01322945|Primary|Change in Mean Survey Response From Baseline to 90 Days Post Surgery|Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.|Baseline, 90 days post surgery|Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.|||units on a scale||Standard Deviation|Mean
2689930|NCT01322841|Secondary|Percentage of Patients Diagnosed With One of the Disorders||six months||||percentage of participants|||Number
2689931|NCT01322841|Primary|Percentage of Patients Screened Positive for One of the Disorders||six months||||percentage of participants|||Number
2689932|NCT01322815|Primary|Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)|Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.|4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients|Patients with RAS mutant positive metastatic colorectal cancer (CRC), either newly diagnosed, or having completed first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen.|||participants|||Number
2689933|NCT01322633|Secondary|Incidence Rate of Overall Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.|||incidence per 100000 person-years||95% Confidence Interval|Number
2689934|NCT01322633|Secondary|Incidence Rate of Composite Gastrointestinal Cancers|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.|||incidence per 100000 person-years||95% Confidence Interval|Number
2689935|NCT01322633|Primary|Incidence Rate of Gastric Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.|||incidence per 100000 person-years||95% Confidence Interval|Number
2689936|NCT01322607|Secondary|Balance|Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).|3 months||||units on a scale||Standard Deviation|Mean
2689937|NCT01322607|Secondary|Muscular Endurance|Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.|3 months||||seconds||Standard Deviation|Mean
2689938|NCT01322607|Secondary|Muscular Strength|Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.|3 months||||newtons (N)||Standard Deviation|Mean
2690286|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 6 (Maintenance Period Month 2)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
2689939|NCT01322607|Primary|Economy of Gait|Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.|3 months||||ml/kg/min||Standard Deviation|Mean
2689940|NCT01322594|Secondary|Clearance (CL)|CL of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||L/Days||Standard Deviation|Mean
2689941|NCT01322594|Secondary|Apparent Terminal Elimination Phase Half-life (t1/2)|t1/2 of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||Days||Standard Deviation|Mean
2689942|NCT01322594|Secondary|Observed Maximum Concentration (Cmax)|Cmax of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||ng/mL||Standard Deviation|Mean
2689943|NCT01322594|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI2338|Number of participants with ADA to MEDI2338|Days 1, 57, and 92|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA|||Participants|||Number
2689944|NCT01322594|Secondary|Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point|Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||ng x day/mL||Standard Deviation|Mean
2689945|NCT01322594|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity|Area under the serum concentration-time curve from time zerio to infinity of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||ng x day/mL||Standard Deviation|Mean
2689946|NCT01322594|Primary|Incidence of Clinically Significant Serum Chemistry Laboratory Results|Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
2689947|NCT01322594|Primary|Incidence of Clinically Significant Vital Signs Results|Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
2689948|NCT01322594|Primary|Incidence of Clinically Significant Electrocardiogram Results|Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
2689949|NCT01322594|Primary|Incidence of Clinically Significant Hematology Laboratory Results|Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
2689950|NCT01322594|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
2689951|NCT01322594|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
2689952|NCT01322490|Secondary|Number of Subjects Alive Without Event at 6 Months|"A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.~Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death."|Randomization through Week 25/End of Treatment visit.|Intent to treat, including all randomized subjects.|||Participants|||Count of Participants
2689953|NCT01322490|Primary|Overall Survival|"The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of definite loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1."|Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.|Intent to treat, including all randomized subjects.|||Months||95% Confidence Interval|Median
2689954|NCT01322386|Primary|Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia|Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia through improvement of Liver function tests (LFTs) within 3 months of initiating therapy. In addition for PSC, we looked at 25% reduction of abnormal ALT & GGT, reduction in biliary strictures and beading, and reduction of inflammation in liver biopsies and colon biopsies.|Within 3 months of therapy|Ten BA participants had surgery (Kasai portoenterostomyprocedure) at 1 week before starting the Vancomycin so we could not determine if they benefited from the therapy. On oral vancomycin, 9 PSC patients had improvement of LFTs, 8 had improvement of liver biopsies and/or MRI, and colon biopsies,and 1 pt. refused to have these additional studies.|||participants|||Number
2689955|NCT01322360|Secondary|Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade|Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade|Up to 21 days||||participants|||Number
2689956|NCT01322360|Primary|Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation|"The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade.~Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator."|Up to 21 days|75 subjects were screened and 50 subjects took at least one dose of oral morphine sulfate.|||participants|||Number
2689957|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.|||grams per liter||Standard Deviation|Mean
2689958|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
2689959|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.|||grams per liter per week||Standard Deviation|Mean
2689960|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||percentage||Standard Deviation|Mean
2689961|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
2689962|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||micrograms per liter||Standard Deviation|Mean
2689963|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||picograms||Standard Deviation|Mean
2689964|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
2690009|NCT01320943|Secondary|Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm||Weeks 48, 96, and 144|Full Analysis Set (FAS): participants who were randomized to Stop TDF group and had a baseline visit or who were randomized to Continue TDF group and received at least 1 dose of study drug. Proportions are based on the Kaplan-Meier estimate.|||Proportion of participants||95% Confidence Interval|Number
2689965|NCT01322347|Secondary|Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percentage of change from baseline||Standard Deviation|Mean
2689966|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects|||units of red blood cells or whole blood|||Number
2689967|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects|||participants|||Number
2689968|NCT01322347|Secondary|Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromole per liter||Standard Deviation|Mean
2689969|NCT01322347|Secondary|Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percent||Standard Deviation|Mean
2689970|NCT01322347|Secondary|Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
2689971|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.|||grams per liter||Standard Error|Least Squares Mean
2689972|NCT01322048|Secondary|Plasma Norepinephrine Levels||Post-treatment (t=Day 8)|Of those surviving treatment period|||pg/mL||Inter-Quartile Range|Median
2689973|NCT01322048|Primary|Ventilator-free Days||Baseline to day 28||||days||Inter-Quartile Range|Median
2689974|NCT01322022|Primary|Actigraphy - Sleep Latency|Measure of sleep latency defined by the time from lights off to sleep onset.|Baseline, Week 4, Week 8||||minutes||Standard Deviation|Mean
2689975|NCT01322022|Primary|Actigraphy - Sleep Efficiency|Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off|Baseline, Week 4, Week 8||||Percentage of Time Sleeping||Standard Deviation|Mean
2689976|NCT01322022|Secondary|Actigraphy - Total Sleep Time|Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.|Baseline, Week 4, Week 8||||minutes||Standard Deviation|Mean
2689977|NCT01322022|Primary|Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index|The MSPSQ used by Wiggs and colleagues (Wiggs & Stores, 1996 ; Wiggs & Stores, 1999 : Wiggs & Stores, 2004) was used to assess the child's sleep quality. It was completed by the primary caregiver for both groups at baseline and at weeks 4 and 8. Using Wiggs & Stores earlier-described conventions for determining the Composite Sleep Index (CSI) score, the CSI was calculated by assigning a score to the frequency of the targeted sleep problems: bedtime resistance, night awakening, early awakening, and sleeping in places other than bed. In addition, scores were assigned for the duration of sleep latency and night awakenings. The total CSI score ranged from 0 to 12, with higher scores indicating more severe bedtime and sleep patterns.|Baseline, Week 4, and Week 8||||units on a scale||Standard Deviation|Mean
2689978|NCT01322009|Secondary|Antioxidant Reserve|Antioxidant reserves in CSF and serum will be calculated in both treatment arms and compared.|Within 5 days of injury||||reactive oxygen species scavenged||Standard Error|Mean
2690290|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 2|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
2689979|NCT01322009|Primary|Number of Participants Who Experienced Adverse Events|"The number of patients experiencing one or more of the following adverse events:~Acute renal failure Anaphylaxis Acute respiratory distress syndrome Intracranial infection/abscess Arrhythmia, atrial Arrhythmia, ventricular Bradycardia Cardiac arrest Catheter positive culture Cerebrospinal fluid leak Decubitis Deep vein thrombosis Diabetes Insipidus Emesis Extraaxial hematoma Gastrointestinal bleed Gastritis Hematuria Hemorrhage, other Hemoperitonium Hemothorax Hepatitis Hydrocephalus Hypotension Hypoxemia Infection, other Intraparenchymal hemorrhage Intraventricular hemorrhage Meningitis/ventriculitis Multiorgan dysfunction syndrome Myocardial ischemia Pancreatitis Pericarditis Peritonitis Pneumothorax Pulmonary edema Pulmonary embolism Respiratory arrest Seizures Sepsis Syndrome of inappropriate antidiuretic hormone Transtentorial herniation Withdrawal of Life Support Other SAE causing re-hospitalization Other SAE"|14 days after drug administration||||participants|||Number
2689980|NCT01321879|Primary|Patient Clinical Response to Telavancin|Clinical response assessed: Cure (No fever/chills or symptoms + eradication causing organism); Improvement (Resolution local/systemic symptoms + no new systemic antibacterial treatment); Failure (IF one or more following: Persistence 1+ symptoms [fever/chills] + new systemic anti gram positive treatment, > 72 hours after initiation study drug; or Relapse within 1 month completing antibiotic therapy; or Development of deep-seated infection not previously assessed); Indeterminate (clinical signs and symptoms cannot be assessed).|From baseline up to 6 weeks, assessed every 7 days|Three patients received <72 hours of Telavancin treatment and therefore were excluded from the efficacy analysis.|||Participants|||Count of Participants
2689981|NCT01321749|Secondary|Brain Perfusion Improvement Are Evaluated With SPECT and TCD|Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.|300-day after treatment|||||||
2689982|NCT01321749|Secondary|The Time Point Until the First Stroke Recurrence,|These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.|At the 300-day after the initial treatment|||||||
2689983|NCT01321749|Primary|Number of Patients Who Got New Brain Lesions|We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)|300 days after treatment||||participants|||Number
2689984|NCT01321749|Primary|Plasma Biomarkers of Coagulation and Fibrinolysis|blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer|the time points of baseline and 1, 15 and 30 days after BLIPC treatment|||||||
2689985|NCT01321749|Primary|Blood Pressure and Heart Rates;||at the time points of baseline and 1, 15 and 30 days after BLIPC treatment|||||||
2689986|NCT01321723|Secondary|% Change From Baseline in Bone Formation Marker (P1NP) at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.|||percentage of change||Standard Deviation|Mean
2689987|NCT01321723|Secondary|Systemic Absorption of PTH at Week 24|AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)|24 weeks||||pg* hr/mL||Standard Deviation|Mean
2689988|NCT01321723|Secondary|% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24|Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.|24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.|||percentage of change||Standard Deviation|Mean
2689989|NCT01321723|Post-Hoc|Number of Participants With AEs as a Measure of Safety and Tolerability||24 weeks|Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events.|||participants|||Number
2689990|NCT01321723|Primary|% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.|||percentage of change||Standard Deviation|Mean
2689991|NCT01321710|Primary|Change in Infant Sleep Quantity (Objective)|Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.|24 hours before and 24 hours after immunizations at approximately 2 months of age|ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.|||minutes||Standard Deviation|Mean
2689992|NCT01321710|Secondary|Maternal Well-being|Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.|1 month postpartum (approximately)|ITT analysis.|||Scores on a scale||Standard Deviation|Mean
2689993|NCT01321710|Secondary|Maternal Sleep Disturbance (Subjective)|Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.|1 month postpartum (approximately)|ITT analysis.|||Scores on a scale||Standard Deviation|Mean
2689994|NCT01321710|Primary|Maternal Sleep Quality (Objective)|Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.|1 month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.|||percentage of sleep per time in bed||Standard Deviation|Mean
2689997|NCT01321606|Secondary|Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells|This outcome is the mean difference in the % of monocytes that phagocytized E. coli, from blood samples taken at the beginning and end of the trial. Percent of monocytes phagocytizing E. coli at baseline is subtracted by percent of monocytes phagocytizing E. coli at the end of the trial. The mean and standard error are calculated and reported for each study arm.|4 weeks|Some participants were excluded from this analysis due to lack of sample collection, or unusable results because tests did not meet acceptability criteria.|||Difference in % POS of Monocytes||Standard Error|Mean
2689998|NCT01321606|Secondary|Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells|This outcome is the mean difference in the % of granulocytes that phagocytized E. coli, from blood samples taken at the beginning and end of the trial. Percent of granulocytes phagocytizing E. coli at baseline is subtracted by percent of granulocytes phagocytizing E. coli at the end of the trial. The mean and standard error are calculated and reported for each study arm. This result|4 weeks|Some participants were excluded from this analysis due to lack of sample collection, or unusable results because tests did not meet acceptability criteria.|||Difference in % POS of Granulocytes||Standard Error|Mean
2689999|NCT01321606|Primary|Oral L. Rhamnosus HN001 Therapy Compared to Placebo on Gastrointestinal and Extra-gastrointestinal Colonization of S. Aureus.|Participants in the final outcome may be colonized at both GI and Extra-GI sites, thus the total numbers from the outcome cells can be greater than the overall number of participants analyzed.|4 weeks||||Participants|||Count of Participants
2690000|NCT01321554|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve||Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose|The PK analysis set included all the participants who received at least one dose of study drug and had evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||Full Range|Median
2690001|NCT01321554|Secondary|Overall Survival (OS)|Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.|Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.|||months||95% Confidence Interval|Median
2690002|NCT01321554|Secondary|Overall Response Rate (ORR)|ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2690003|NCT01321554|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded IIR using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.|||months||95% Confidence Interval|Median
2690004|NCT01321073|Primary|Rate of Catheter-related Complications Per 1000 Patient Days|A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.|Implant to 2 years|All days of follow-up for implanted patients|||complications per 1000 patient-days|Patient days||Number
2690005|NCT01321008|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.|Day 1 to disease progression or death (up to 5+ years)|Study terminated early, no analysis available.||||||
2690006|NCT01320943|Secondary|Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms|HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.|Week 96|HBsAg Loss and Seroconversion Full Analysis Set|||Proportion of participants||95% Confidence Interval|Number
2690007|NCT01320943|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)||Baseline to Week 144|Participants in the Full Analysis Set with available data were analyzed. Percentages are based on the number of participants with non-missing laboratory test results at each visit. One participant restarted TDF during Weeks 72 and 120 and thus was reported in both the Stop TDF and Re-Start TDF groups based on the date of TDF restart.|||Percentage of participants|||Number
2690008|NCT01320943|Secondary|Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)|Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.|Baseline to Week 144|Participants in the FAS with available data were analyzed. When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. 1 participant restarted TDF during Wk 72, thus was reported in both Stop TDF and Restart TDF arms based on the TDF restart date.|||Percentage of participants|||Number
2690287|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 1|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 5 (Maintenance Period Month 1)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
2690010|NCT01320943|Secondary|Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms|"The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF~When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF."|Baseline to Week 144|Participants in the Full Analysis Set ( participants who were randomized to Stop TDF arm and had a baseline visit or who were randomized to Continue TDF arm and received at least 1 dose of study drug) with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2690011|NCT01320943|Secondary|Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144|HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.|Weeks 96 and 144|HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least 1 post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.|||Proportion of participants||95% Confidence Interval|Number
2690012|NCT01320943|Primary|Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms|HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.|Week 144|HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least one post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.|||Proportion of participants||95% Confidence Interval|Number
2690013|NCT01320826|Primary|Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."|[When pathology from colonoscopy available (on average 2-3 weeks after procedure)]|For this outcome, we only examined females ≥ 50 years old having their first colonoscopy|||percentage of females||95% Confidence Interval|Mean
2690014|NCT01320826|Secondary|Percentage of Patients Referred to a Specialist.|The percentage of patients who are anticipated to be referred to specialists, for the gastrointestinal complaint for which the colonoscopy was performed will be determined and the reason for referral will be tabulated. The referral percentage will be determined both from the time of colonoscopy (physician reported) and from the patient satisfaction phone survey (patient reported).|Within four (4) weeks of colonoscopy||||percentage of patients|||Number
2690015|NCT01320826|Secondary|Colonoscopy Procedure Time|Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.|At time of colonoscopy (DAY 1 of study)||||minutes||95% Confidence Interval|Mean
2690016|NCT01320826|Secondary|Patient Satisfaction With Hospital Experience for Colonoscopy|"Patient satisfaction with their hospital experience during their colonoscopy will be recorded by using a 7 point Likert scale at the time of the patient satisfaction phone survey.~7 = extremely satisfied~1 = extremely dissatisfied~Minimum score = 1 Maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients consented to and completed the post procedural satisfaction survey.|||units on a scale||Inter-Quartile Range|Median
2690017|NCT01320826|Secondary|Patient Satisfaction With Endoscopy Wait Time|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients completed the post procedural satisfaction survey.|||units on a scale||Inter-Quartile Range|Median
2690018|NCT01320826|Secondary|Patient Comfort During Colonoscopy|"To determine the patients' comfort level during the colonoscopy, a five-item question used by the Joint Advisory Group on Gastrointestinal Endoscopy in the United Kingdom will be used.~Patient discomfort on the 5 point scale:~0 is no discomfort;~is one or two episodes of discomfort, well tolerated;~is more than two episodes of discomfort adequately tolerated;~is significant discomfort experienced several times during the procedure;~is extreme discomfort experienced frequency throughout the procedure.~Minimum value = 0, maximum value = 4 with 4 being worse."|At time of colonoscopy (DAY 1 of study)||||units on the scale||Standard Deviation|Mean
2690019|NCT01320826|Secondary|Colonoscopy Withdraw Time in Cases Where no Lesions Found|Withdrawal time will be defined as the time from leaving the cecum until the colonoscope exits the anus. This will be calculated for cases in which no lesions were found.|At time of colonoscopy (DAY 1 of study)|Only examined patients in which no lesions were detected.|||minutes||95% Confidence Interval|Mean
2690020|NCT01320826|Secondary|Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."|Within four (4) weeks of colonoscopy||||patients undergoing colonoscopy|||Number
2690021|NCT01320826|Primary|Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|We only examined this outcome for males 50 years and older having their first colonoscopy|||percentage of males||95% Confidence Interval|Mean
2690022|NCT01320826|Primary|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|Number of patients who underwent colonoscopy|||adenomas / colonoscopy||95% Confidence Interval|Number
2690288|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 4|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
2690023|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Adjusted)|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)|At time of colonoscopy (DAY 1 of study)||||percentage of colonoscopies attempted||95% Confidence Interval|Number
2690024|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100|At time of colonoscopy (DAY 1 of study)|Prospective, observational study, all study participants were analyzed|||percentage of colonoscopies performed||95% Confidence Interval|Number
2690025|NCT01320735|Secondary|Median Percentage of Time Off-treatment During 2 Years IAD Regimen|The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.|||Percentage of time off-treatment||Full Range|Median
2690026|NCT01320735|Primary|Number of Participants Who Switched to IAD Regimen by Visit|The data are reported as number of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Participants|||Number
2690027|NCT01320735|Secondary|Mean Duration of Treatment-off Time in IAD Regimen|Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin [cycle N+1] minus last dose date [cycle N] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.|||Months||Standard Deviation|Mean
2690028|NCT01320735|Primary|Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen|The data are reported as percentage of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Percentage of participants|||Number
2690029|NCT01320735|Other Pre-specified|Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.|||Participants|||Number
2690030|NCT01320735|Other Pre-specified|Number of Participants Who Received IAD Regimen During the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.|||Participants|||Number
2690031|NCT01320735|Secondary|Median Survival Time|Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Participants who died while on study were used for analysis.|||Months||Full Range|Median
2690032|NCT01320735|Secondary|Median Time to Progression of HRPC in Participants Not Started on IAD Regimen|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements of participants who did not start on IAD regimen.|||Months||95% Confidence Interval|Median
2690033|NCT01320735|Secondary|Median Time to Progression of HRPC|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.|||Months||Full Range|Median
2690034|NCT01320735|Primary|Median Number of Leuprorelin Cycles|The Participants were on IAD regimen and the data are reported as number of cycles with full range.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. However, one participant started continuous hormone therapy and was not included in the analysis.|||Cycles||Full Range|Median
2690035|NCT01320735|Secondary|Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)|Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.|||Participants|||Number
2690036|NCT01320735|Primary|Mean Duration of Each Leuprorelin Cycle|Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Months||Standard Deviation|Mean
2690049|NCT01320683|Primary|Progression-free Survival|"Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 24 months|||||||
2690037|NCT01320735|Primary|Mean Duration of Leuprorelin Exposure|Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Months||Standard Deviation|Mean
2690038|NCT01320735|Other Pre-specified|Duration of IAD Regimen Induction Phase|Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.|At least 6-9 months after Baseline (enrollment)|Data are of measurements collected from participants who started IAD.|||Months||Standard Deviation|Mean
2690039|NCT01320722|Secondary|Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping|A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values.|Baseline and Week 8|All randomized enrolled participants with complete 24-hour ABP data available for analysis.|||percent change||Standard Deviation|Mean
2690040|NCT01320722|Secondary|Mean 24-Hour Ambulatory Blood Pressure (ABP)|A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours.|Baseline and Week 8|All randomized enrolled participants with complete 24-hour ABP data available for analysis.|||mmHg||Standard Deviation|Mean
2690041|NCT01320722|Secondary|Change in Endothelium-Dependent Vasodilation (EDV)|Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter * 100.|Baseline and Week 8 (pre and post ischaemic stimulus)|All randomized enrolled participants.|||percent of brachial luminal diameter||Standard Deviation|Mean
2690042|NCT01320722|Primary|Angiotensin II (ATII) Concentration [Uric Acid]|ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants with data available for analysis.|||pg/mL||Inter-Quartile Range|Median
2690043|NCT01320722|Primary|Plasma Renin Activity (PRA) [Uric Acid]|PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants with data available for analysis.|||ng/mL per hour||Inter-Quartile Range|Median
2690044|NCT01320722|Primary|Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]|RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.|Week 8 (pre and post captopril)|All randomized enrolled participants with data available for analysis.|||mL/min per 1.73 m^2||Inter-Quartile Range|Median
2690045|NCT01320722|Primary|Angiotensin II (ATII) Concentration [Vitamin D]|ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants included in the analysis.|||pg/mL||Standard Deviation|Mean
2690046|NCT01320722|Primary|Plasma Renin Activity (PRA) [Vitamin D]|PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants included in the analysis.|||ng/mL per hour||Standard Deviation|Mean
2690047|NCT01320722|Primary|Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]|Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.|Week 8 (pre and post captopril)|All randomized enrolled participants included in the analysis.|||mL/min per 1.73 m^2||Standard Deviation|Mean
2690048|NCT01320683|Secondary|Overall Survival|Overall Survival is calculated for all patients from the date of initial treatment to date of death due to any cause. Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method, and 95% confidence limits calculated for these estimates.|Up to 5 years|||||||
2690050|NCT01320553|Secondary|Ciliary Redness Evaluated by the Investigator|Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed.|Up to 4 weeks||||units on a scale||Standard Deviation|Mean
2690051|NCT01320553|Primary|Ocular Itching|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.|Up to 28 days|"Of the 122 subjects enrolled in the study, a total of 8 subjects did not complete the study: 1 in the 1334H 0.15% group, 4 in the 1334H 0.3% group, 2 in the 1334H 0.45% group and 1 in the vehicle treated group.~The Per Protocol population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects."|||units on a scale||Standard Deviation|Mean
2690052|NCT01320293|Secondary|Changes in Adiponectin Profile Compared to Baseline|Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.|24 weeks|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.|||pg/ml||95% Confidence Interval|Mean
2690053|NCT01320293|Secondary|Changes in IL-6 Profile Compared to Baseline|IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.|||pg/ml||95% Confidence Interval|Mean
2690054|NCT01320293|Primary|Percentage Change in Endothelial Function Compared to Baseline.|Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.|||percent change||95% Confidence Interval|Mean
2690055|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized patients who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
2690056|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
2690057|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||grams per liter per week||Standard Deviation|Mean
2690058|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percentage of saturation||Standard Deviation|Mean
2690059|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
2690060|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micrograms per liter||Standard Deviation|Mean
2690061|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||picograms||Standard Deviation|Mean
2690062|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
2690085|NCT01319994|Secondary|HOMA2-IR|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). HOMA2-IR is calculated using the HOMA model: www.dtu.ox.ac.uk/homacalculator/|3 months minus baseline||||HOMA score||Standard Deviation|Mean
2690063|NCT01320202|Secondary|Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percentage of change||Standard Deviation|Mean
2690064|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.|||units of red blood cells or whole blood|||Number
2690065|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.|||participants|||Number
2690066|NCT01320202|Secondary|Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromole per liter||Standard Deviation|Mean
2690067|NCT01320202|Secondary|Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to treat: all randomized subjects who had at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percent||Standard Deviation|Mean
2690068|NCT01320202|Secondary|Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat population: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
2690069|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.|||grams per liter||Standard Error|Least Squares Mean
2690070|NCT01320150|Primary|Number of Subjects With Post-Operative Persistent Pain (PPP)|"PPP for this study will be defined as pain in the operated knee at six months after Total Knee Replacement surgery, with other causes of pain excluded, and a reported intensity on 0-10 Numerical Response Scale (NRS) of ≥4 where higher pain scores indicate higher levels of pain. NRS scores range from 0 {No Pain} to 10 {Worst Imaginable Pain}."|6 months postoperatively||||Participants|||Count of Participants
2690071|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition|Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
2690072|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)|Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
2690086|NCT01319994|Primary|CT Abdomen|change in visceral/subcutaneous fat|3 months minus baseline||||ratio||Standard Deviation|Mean
2690087|NCT01319877|Secondary|Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.|Up to 36 Months|Evaluable participants.|||score on a scale||Standard Deviation|Mean
2690073|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition|"Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays.~Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation."|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
2690074|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines|"Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays.~Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation"|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
2690075|NCT01320072|Secondary|Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients|We will assess FEV1% change from baseline at 12 months in AERD patients who have been on aspirin treatment for 12 months (current standard of care)|12 months|AERD patients will continue aspirin treatment for 12 months and the change from baseline in their FEV1% predicted will be monitored during this time|||change in percent predicted FEV1||Standard Error|Mean
2690076|NCT01320072|Secondary|Treatment-Related Adverse Events|Adverse reactions defined as bronchospasm requiring endotracheal intubation. The adverse reactions will be assessed through a post challenge follow-up with the patient at baseline and 24 hours after the challenge|24 hours after the challenge||||participants|||Number
2690077|NCT01320072|Primary|Eicosanoid Metabolites Concentration|eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge|2 hours||||log-pg/mg creatinine||Standard Error|Mean
2690078|NCT01320033|Secondary|Number of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported.|From Baseline up to Week 16|Safety Population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2690079|NCT01320033|Secondary|Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16|Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions.|Baseline, Week 12, and Week 16|ITT population consisted of all participants who were randomized and to whom study drug was dispensed.|||Units on a scale||Standard Deviation|Mean
2690080|NCT01320033|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])|The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported|From Baseline up to Week 16 (LOCF)|ITT population consisted of all participants who were randomized and to whom study drug was dispensed.|||lesion count||Standard Deviation|Mean
2690081|NCT01320033|Secondary|Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])|Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported.|From Baseline up to Week 16 (LOCF)|ITT population consisted of all participants who were randomized and to whom study drug was dispensed.|||percent change||Standard Deviation|Mean
2690082|NCT01320033|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])|The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.|From Baseline up to Week 16 (LOCF)|ITT population consisted of all participants who were randomized and to whom study drug was dispensed.|||percent change||Standard Deviation|Mean
2690083|NCT01320033|Secondary|Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])|IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules [inflammatory lesions]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions [papules/pustules only; no nodulo-cystic lesions]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF).|Week 16 (LOCF)|ITT Population consisted of all participants who were randomized and to whom study drug was dispensed.|||Percentage of participants|||Number
2690084|NCT01320033|Primary|Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])|The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.|From Baseline up to Week 16 (LOCF)|Intent To Treat (ITT) population consisted of all participants who were randomized and to whom study drug was dispensed.|||lesion count||Standard Deviation|Mean
2690089|NCT01319877|Secondary|One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.|1 year|Participants with known prior chemotherapy regimens were evaluated.|||percentage of participants||95% Confidence Interval|Number
2690090|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.|Up to 36 Months|Participants with known prior chemotherapy regimens were evaluated|||percentage of participants||95% Confidence Interval|Number
2690091|NCT01319877|Secondary|One-year Survival Rate by the KRAS Subgroup||1 year|Participants with known KRAS status were evaluated|||percentage of participants||95% Confidence Interval|Number
2690092|NCT01319877|Secondary|One-year Progression-free Survival Rate Per KRAS Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|1 year|Participants with known KRAS status were evaluated.|||percentage of participants||95% Confidence Interval|Number
2690093|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|36 months|Participants with known KRAS status were evaluated.|||percentage of participants||95% Confidence Interval|Number
2690094|NCT01319877|Secondary|One-year Survival Rate||1 year||||percentage of participants||95% Confidence Interval|Number
2690095|NCT01319877|Secondary|One-year Progression-free Survival Rate|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.|1 year||||percentage of participants||95% Confidence Interval|Number
2690096|NCT01319877|Secondary|Progression-free Survival|Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.|36 months||||months||95% Confidence Interval|Median
2690097|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.|36 months||||percentage of participants||95% Confidence Interval|Number
2690098|NCT01319877|Primary|Percentage of Participants With Bevacizumab-related Serious Adverse Events||36 months||||percentage of participants|||Number
2690099|NCT01319877|Primary|Percentage of Participants With Bevacizumab-Related Adverse Events||36 months||||percentage of participants|||Number
2690100|NCT01319877|Primary|Percentage of Participants With Adverse Events of Special Interest||36 months||||percentage of participants|||Number
2690101|NCT01319877|Primary|Percentage of Participants With Serious Adverse Events|A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.|36 months||||percentage of participants|||Number
2690102|NCT01319877|Primary|Percentage of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|36 months||||percentage of participants|||Number
2690103|NCT01319851|Secondary|Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)|The severity criteria of chronic graft-versus-host disease (cGVHD) recommended by the NIH Criteria Consensus (NCC) was employed. The number of organs involved and the severity of the disease in these organs dictated the global summary score used to define the disease as mild, moderate, or severe. Mild disease indicates one or two organs involved each with a maximal score of 1. Moderate disease indicates three or more organs involved with a score of 2 in any individual organ, or lung involvement with a score of 1. Severe global GVHD is defined by a score of 3 in any organ, or a lung score of 2.|Day 100 post-transplant||||participants|||Number
2690104|NCT01319851|Secondary|Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV|Cumulative Incidence of Grade II-IV aGVHD Score at 30 Days. The NIH Consensus grading and severity criteria includes physical assessments of skin, oral cavity, eyes, gynecological and laboratory data and patient reports. Each domain is scored from Grade 0 (no involvement) to Grade IV (severe involvement).|Day 30 post-transplant||||participants|||Number
2690105|NCT01319851|Secondary|Incidence of 100% CD33 Donor Chimerism|CD33 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant||||participants|||Number
2690106|NCT01319851|Secondary|Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism|CD3 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant||||participants|||Number
2690435|NCT01317641|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state||Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||ng/mL||Standard Deviation|Mean
2690108|NCT01319851|Secondary|Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity|Regimen-related toxicity was measured using the Bearman criteria. The Bearman criteria grades toxicity levels at Grade 1, Grade 2, Grade 3, and Grade 4. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. All regimen-related toxicities were determined to be unlikely attributable to the study drug.|Day 42 post-transplant||||participants|||Number
2690109|NCT01319851|Primary|Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment|All subjects received alefacept prior to hematopoietic stem cell transplantation and were followed up to at least two years after transplantation to ensure successful engraftment.|Two years post-transplant||||participants|||Number
2690110|NCT01319812|Secondary|Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).|Summary of serious adverse event rates at 36 months. Refer to SAE section.|36 months|Pulsar Stent Group Post Market Analysis.|||Participants|||Count of Participants
2690111|NCT01319812|Secondary|Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).||36 Months|Evaluable participants for stent fracture at 36 months. Pulsar Stent Group Post Market Analysis.|||Participants|||Count of Participants
2690112|NCT01319812|Secondary|Number of Participants With Stent Fracture at 24 Months (Post Approval).||24 Months|Evaluable participants for stent fracture at 24 months. Pulsar Stent Group Post Market Analysis.|||Participants|||Count of Participants
2690113|NCT01319812|Secondary|Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)||36 Months|Evaluable participants for TLR at 36 months. Pulsar Stent Group Post Market Analysis.|||percentage of participants||95% Confidence Interval|Number
2690114|NCT01319812|Secondary|Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)||24 Months|Evaluable participants for TLR at 24 months.|||percentage of Participants||95% Confidence Interval|Number
2690115|NCT01319812|Secondary|Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).|Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent.|36 Months|Evaluable participants at 36 months.|||percentage of participants||95% Confidence Interval|Number
2690116|NCT01319812|Secondary|Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)|Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.|24 Months|Evaluable participants at 24 months.|||percentage of participants||95% Confidence Interval|Number
2690117|NCT01319812|Secondary|Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)|Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent.|24 Months|Evaluable participants for TLR at 24 months.|||Participants|||Count of Participants
2690118|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success|Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|30 days|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690119|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success|Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|Acute / Date of Procedure|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690120|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months|Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690121|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months|Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690122|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months|Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690123|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months|Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690289|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 3|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
2690124|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate|Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690125|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success|Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|30 days|Includes all participants who underwent implantation.|||Percentage of participants|||Number
2690126|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success|Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|Acute / Date of Procedure|Includes all participants who underwent implantation.|||Percentage of participants|||Number
2690127|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months|Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690128|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months|Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690129|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months|Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.|||Percentage of participants|||Number
2690130|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate|Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|30 days|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
2690131|NCT01319812|Secondary|Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates|Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details.|12 month|Includes all participants who underwent implantation.|||Participants with event|||Number
2690132|NCT01319812|Secondary|Clinical Success|Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure.|30 days|The Astron stent group includes all participants who underwent implantation. The Pulsar stent group includes all participants who underwent implantation except for one, due to subject death occurring in the first 30 days.|||Percentage of participants||95% Confidence Interval|Number
2690133|NCT01319812|Secondary|Acute Procedural Success for Astron and Pulsar Stent|Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge.|30 days|Includes all participants who underwent implantation.|||Percentage of participants||95% Confidence Interval|Number
2690134|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ stair climbing scores were available for 142 participants from both baseline and the 12-month visit for the Astron stent group. WIQ stair climbing scores were available for 255 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
2690155|NCT01319773|Primary|Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)|Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.|Day 1|Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.|||Nanogram/milliliter (ng/mL)|||Number
2690156|NCT01319760|Secondary|Infarct Size|Assessment of infarct size and remodeling characteristics at 90 days post-infarct.|90 Days|No data for primary or secondary endpoints were collected in this study||||||
2690135|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ walking speed scores were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking speed scores were available for 263 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
2690136|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ walking distance scores were available for 144 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking distance scores were available for 264 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
2690137|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ PAD responses were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ PAD responses were available for 265 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
2690138|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test|The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure.|12 months|Analysis conducted on paired data. Six-minute walk test results were available for 131 participants from both baseline and the 12-month visit for the Astron stent group. Six-minute walk test results were available for 247 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Feet||Standard Deviation|Mean
2690139|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement|The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm.|12 months|Analysis conducted on paired data. ABI measurements were available for 141 participants from both baseline and the 12-month visit for the Astron stent group. ABI measurements were available for 266 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Ratio (ABI score)||Standard Deviation|Mean
2690140|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency|Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants||95% Confidence Interval|Number
2690141|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency|Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants||95% Confidence Interval|Number
2690142|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate|Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.|12 months|Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.|||Percentage of participants||95% Confidence Interval|Number
2690143|NCT01319812|Secondary|Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate|Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.|12 months|Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.|||Percentage of participants||95% Confidence Interval|Number
2690157|NCT01319760|Primary|No Data for Primary or Secondary Enpoints Were Collected||No data for primary or secondary enpoints were collected|No data from primary or secondary endpoints were collected in this study||||||
2690158|NCT01319760|Primary|Infarct Size|Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).|3-5 Days post infarct|No data for primary or secondary endpoints were collected in this study||||||
2690144|NCT01319812|Secondary|Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate|Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V.|12 months|Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation.|||Participants|||Count of Participants
2690145|NCT01319812|Secondary|Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate|Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.|12 months|Participants who reached at least 395 calendar days post procedure.|||Percentage of participants||95% Confidence Interval|Number
2690146|NCT01319812|Secondary|Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation|Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.|30 days|All participants implanted with an Astron Pulsar or Pulsar-18 stent.|||Percentage of participants||95% Confidence Interval|Number
2690147|NCT01319812|Primary|Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)|Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.|36 Months||||percentage of participants||95% Confidence Interval|Number
2690148|NCT01319812|Primary|Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)|The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.|12 months|Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.|||Percentage of participants||95% Confidence Interval|Number
2690149|NCT01319812|Primary|Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events|The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.|30 days|All participants implanted with an Astron Pulsar or Pulsar-18 stent.|||Percentage of participants||95% Confidence Interval|Number
2690150|NCT01319812|Primary|Effectiveness Endpoint for the Pulsar Stent: Primary Patency|The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.|12 months|Participants for whom patency could be confirmed at 12 months.|||Percentage of participants||95% Confidence Interval|Number
2690151|NCT01319799|Secondary|Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter)|"Differences in preoperative vs postoperative CSF levels of S-100B in microgram/Liter~The assumption is that a cardiac open heart surgical procedure with cardiopulmonary bypass will influence the postoperative level of marker of neuronal cell damage in the central nerve system. An increase in the levels, compared to the preoperative values, indicates neuronal cell damage detectable in the CSF, namely the brains own extracellular fluid."|24 Hours after Surgery||||microgram/Liter||Standard Error|Mean
2690152|NCT01319799|Primary|Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery|Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery. Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted. The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted. The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure. A high value is negative for the patient.|(day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance||||units on a scale||Standard Error|Mean
2690153|NCT01319773|Secondary|Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1|Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).|Day 1|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.|||Number of Eyes|Participants||Number
2690154|NCT01319773|Secondary|Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)|Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).|3 Days|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.|||Number of Subjects|||Number
2690159|NCT01319721|Secondary|Postoperative Conjunctival Inflammation|The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe).|One month||||eyes|Participants||Number
2690163|NCT01319721|Primary|Recurrence|Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea.|One Year||||eyes|Participants||Number
2690164|NCT01319617|Primary|Ocular Discomfort|Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.|After 24 hours of device wear||||mm||Standard Deviation|Mean
2690165|NCT01319552|Primary|Measure of Non-transferrin-bound Iron|"Comparison of increase in non-transferrin-bound iron for each participant between his or her fresh and old blood transfusion four hours after transfusion."|four hours after transfusion||||μM||Standard Deviation|Mean
2690166|NCT01319539|Secondary|Change in Ki-67 Expression|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.|||percentage of cells||Standard Deviation|Mean
2690167|NCT01319539|Secondary|Change in pS6 Levels|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.|||percentage of cells||Standard Deviation|Mean
2690168|NCT01319539|Primary|Change in pAKT Levels|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.|||percentage of cells||Standard Deviation|Mean
2690169|NCT01319500|Primary|Reasons for OC Prescriptions by Gynecologists and Dermatologists||February 2009 - March 2009||||number of participants|||Number
2690170|NCT01319500|Primary|Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)|"Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category non-contraceptive reasons only"|February 2009 - March 2009||||number of participants|||Number
2690171|NCT01319500|Primary|"Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons"|"Non-contraceptive reasons for OC prescriptions (including both categories: contraception plus non-contraceptive reasons and non-contraceptive reasons only"|February 2009 - March 2009||||number of participants|||Number
2690172|NCT01319500|Primary|Reasons for OC Prescriptions|The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.|February 2009 - March 2009||||percentage of participants||95% Confidence Interval|Number
2690173|NCT01319500|Primary|OC Prescriptions by Treatment Group and Prescribing Medical Specialists|Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)|February 2009 - March 2009||||Prescribing physicians|||Number
2690174|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin With Cytokine Profile.|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|The actin polymerization assay that was to be used for this outcome was not reproducible; hence, the cytokine profile of actin polymerized cells could not be pursued. Data were not analyzed.||||||
2690175|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin Polymerization With Adverse Effects and Clinical Responses.|Research bone marrow aspirate is obtained to assess response (optional, but recommended), and to document complete remission, if applicable. Correlation to be determined upon completion of study treatment|Research bone marrow aspirate is obtained at baseline and after completion of 2 cycles of therapy (approximately 56 days)|The actin polymerization assay that was to be used for this outcome was not reproducible and data were not analyzed.||||||
2690176|NCT01319422|Secondary|To Compare the Effect of Continuous Versus Intermittent Regimens on F Actin Polymerization in Peripheral Blood Mononuclear Cells and Activation of Tumor Antigen-specific T Cells, as Well as Innate Lymphocytes (Natural Killer or Natural Killer T Cells).|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|N/A: data were not collected on this outcome; initial F actin polymerization assay was unreliable and not reproducible; hence, this outcome could not be pursued.||||||
2690177|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).||||percentage of participants|||Number
2690178|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days)||||percentage of participants|||Number
2690179|NCT01319396|Primary|Accuracy of Breathing Rate Measurement|accuracy of breathing rate indicated by the BiancaMed BM07 device, compared to that indicated by Somnoscreen to be +/- 5 breaths per minute (95% confidence)|2 minutes|Each participant gives 8 test points, thus with 22+ participants, there are >160 test points, which is sufficient to give a standard deviation.|||breaths per minute||Standard Deviation|Mean
2690436|NCT01317641|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state|AUC(0-8h)|Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||h*ng/mL||Standard Deviation|Mean
2690180|NCT01319383|Other Pre-specified|Number of Participants Developing Cancer Within 5 Years Following >/= 8 Vorinostat Dose Exposures|Development of a new cancer within the 5 years of taking their last dose of VOR 400 mg PO.All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study. Pre-specified to be reported as one group.|From last dose Vorinostat to 5 years afterwards|At end of study, participants receiving >/= 8 doses of Vorinostat are enrolled in a 5-year cancer incidence database to be monitored for the occurrence of cancer.|||Participants|||Count of Participants
2690181|NCT01319383|Secondary|Number of Participants With Confirmed Hematologic Toxicity >/= Grade 2 and Related to VOR Per Division of AIDS (DAIDS) Grading Table|DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.|24 hrs following single dose and 1 week after last of multiple dose sequence|All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.|||Participants|||Count of Participants
2690182|NCT01319383|Secondary|Number of Participants With Confirmed Non-hematologic Toxicity >/= Grade 3 and Related to VOR Per Division of AIDS (DAIDS) Grading Table|DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.|24 hrs following single dose and 1 week after last of multiple dose sequence|All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.|||Participants|||Count of Participants
2690183|NCT01319383|Secondary|Number of Participants With Measurable Changes in Plasma HIV-1 RNA|Assess for detectible HIV-1 RNA > 150 copies/mL, confirmed by repeat evaluation, following VOR dose. By standard assay and single copy assay. Pre specified to combine all participants into one arm.|1 week after last VOR dose|All participants receiving one or more doses of VOR in any and all Arms of the study.|||Participants|||Count of Participants
2690184|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Multiple (n = 10) Interval Doses|Participants in Arm 2, Step 4 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after administration of 10 doses of VOR 400 mg PO, given 72 hours apart.|Baseline, Visit 9|Participants who demonstrated a significant in vivo response after taking 2 doses of VOR 400 mg PO, each dose taken 72 hours apart were administered 10 doses of VOR based on the optimal dosing of 72 hours.|||Participants|||Count of Participants
2690185|NCT01319383|Primary|Number of Participants With a Significant in Vivo Response in Resting Cell Infection (RCI) and HIV RNA After Paired Doses|Induction of significant in vivo RCI and RCLV response after 2 doses of VOR 400 mg PO administered 48 hours apart or 72 hours apart|Baseline, Visit 6|Participants showing an in vivo response in resting CD4+ T cell- associated HIV RNA (RCVL) after a single dose of VOR were administered 2 doses of VOR 400 mg separated by either 48 or 72 hours to determine the optimal interval/spacing to observe a significant in vivo response in the RCVL after the paired doses.|||Participants|||Count of Participants
2690186|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Each of Two Multiple Dose Cycles (11 Doses/Cycle)|Participants in Arm 1, Step 3 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after 11 doses of VOR 400 mg PO. This cycle was repeated after a 5 - 8 week rest period for a 2nd series and measurement.|Baseline, Visit 18, Visit 29|Participants with resting CD4+ T-cell-associated HIV RNA (rc-RNA) increases after receiving daily VOR Monday through Wednesday for 8 weekly cycles were enrolled.|||Participants|||Count of Participants
2690187|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T Cell- Associated HIV RNA (RCVL) Increase After Receiving a Single Dose of VOR 400 mg PO|Participants in Arm 1 and 2 were analyzed in Step 2 for an in vivo increase in resting CD4+ T cell- associated HIV RNA (RCVL) after administration of a single dose of VOR 400 mg PO|Arm1: Baseline, Visit 5 and Arm 2: Baseline and Visit 3||||Participants|||Count of Participants
2690188|NCT01319318|Primary|Percentage of Participants With Vitreous Cell Count of 0|The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (>50 cells) worst.|Week 4|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
2690189|NCT01319110|Secondary|Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo|The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.|1 year|This data was not collected when the study was performed||||||
2690190|NCT01319110|Primary|Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients|The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.|Baseline||||ug/mL||Standard Deviation|Mean
2690191|NCT01319045|Secondary|Quality of Life|Change in quality of life as assessed by SF-36 QOL|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained||||||
2690192|NCT01319045|Secondary|Serum Brain Natriuretic Peptide (BNP)|Change in serum BNP level|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained||||||
2690193|NCT01319045|Secondary|Exercise Capacity|Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained||||||
2690194|NCT01319045|Primary|Safety and Tolerability|Number of Participants with adverse events, specifically mortality and heart failure.|3 months|Number of adverse events.|||participants|||Number
2690195|NCT01318993|Secondary|Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks|IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.|Baseline (Week 0) and up to 112 weeks|ITT population was planned to be analyzed for this study. However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.||||||
2690196|NCT01318993|Secondary|Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.|Baseline (Week 0) and up to 112 weeks|ITT population was planned to be analyzed for this study.However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.||||||
2690197|NCT01318993|Secondary|Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.|Baseline (Week 0) and up to 108 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants||95% Confidence Interval|Number
2690198|NCT01318993|Secondary|Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline (Week 0) and up to 108 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Scores on a scale||Standard Deviation|Mean
2690199|NCT01318993|Secondary|Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value|QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)|Safety Population. Only participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2690200|NCT01318993|Secondary|Change From Baseline (Week 0) in Albumin|Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||Grams/Liter (G/L)||Standard Deviation|Mean
2690201|NCT01318993|Secondary|Change From Baseline (Week 0) in Total Bilirubin|Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||micromole/Liter||Standard Deviation|Mean
2690202|NCT01318993|Secondary|Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)|Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||International Unit per Liter (IU/L)||Standard Deviation|Mean
2690214|NCT01318915|Secondary|Participant Renal Function as Measured by GFR Using CKD-EPI|Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. A value less than 15 indicates kidney failure, 15 to 29 indicates severe loss of kidney function, 30 to 44 indicates moderate to severe loss of kidney function, 45 to 59 mild to moderate loss of kidney function, 60 to 89 indicates mild loss of kidney function, and 90 or higher indicates normal kidney function. The equation developed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) is used to estimate GFR from serum creatinine. The value closest to and within 6 weeks of the day expected was selected.|26, 52, 104, 156, and 208 Weeks Post-Transplant|Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.|||mL/min/1.73m^2||Inter-Quartile Range|Median
2690203|NCT01318993|Secondary|Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2690204|NCT01318993|Secondary|Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters|Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.|Baseline (Week 0) and up to Week 112|Safety Population. Only the participants available at the time of analysis were included.|||Participants|||Count of Participants
2690205|NCT01318993|Secondary|Change From Baseline (Week 0) in Heart Rate (HR) Over Period|The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
2690206|NCT01318993|Secondary|Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period|The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2690207|NCT01318993|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product.|Up to Week 112|Safety Population|||Participants|||Count of Participants
2690208|NCT01318967|Secondary|Measurement of Regional Blood Oxygenation by MRI|Estimate of renal blood flow by using MRI scans before and after the administration of furosemide|One measure after furosemide (day 1)||||ml/min||Full Range|Mean
2690209|NCT01318967|Primary|Measurement of Renal Blood Flow of the Kidney by the PAH Method|Renal blood flow is estimated by the PAH method.|Renal blood flow is estimated over 1 hour by PAH||||ml/min||Full Range|Mean
2690210|NCT01318915|Secondary|Participant Glucose Level Over Time|This is a measure of glucose found in the blood. Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. Fasting levels for glucose should be around 70-99 mg/dL and less than 140 mg/dL within 2 hours after a meal. The value closest to and within 6 weeks of the day expected was selected.|26, 52, 104, 156, and 208 Weeks Post-Transplant|Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.|||mg/dL||Inter-Quartile Range|Median
2690211|NCT01318915|Secondary|Participant Total Cholesterol Over Time|Total cholesterol measures the amount of cholesterol found in the blood. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. A value less than 200 mg/dL is considered good. The value closest to and within 12 weeks of the day expected was selected.|26, 52, 104, 156, and 208 Weeks Post-Transplant|Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.|||mg/dL||Inter-Quartile Range|Median
2690212|NCT01318915|Secondary|Participant Diastolic Blood Pressure Over Time|Diastolic blood pressure measures the pressure in the arteries when the heart is at rest and is thus filled with blood. A normal diastolic blood pressure is lower than 80 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. The value closest to and within 6 weeks of the day expected was selected.|26, 52, 104, 156, and 208 Weeks Post-Transplant|Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.|||mmHg||Inter-Quartile Range|Median
2690213|NCT01318915|Secondary|Participant Systolic Blood Pressure Over Time|Systolic blood pressure measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. A normal systolic blood pressure is lower than 120 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. The value closest to and within 6 weeks of the day expected was selected.|26, 52, 104, 156, and 208 Weeks Post-Transplant|Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.|||mmHg||Inter-Quartile Range|Median
2690215|NCT01318915|Secondary|Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies|Adverse events that are reported as being a post-transplant infection, wound complication, lymphocoele (a collection of fluid in the lymphatic system), post-transplant diabetes mellitus or malignancy.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study|||Events|||Number
2690216|NCT01318915|Secondary|Percent of Participants Requiring Anti-lymphocyte Therapy (OKT3, ATG) for an Acute Rejection Event|Anti-lymphocyte therapy is a drug that targets specific cells in the immune system called lymphocytes (white blood cells). This therapy helps stop the participant's immune system from attacking the donor kidney. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study.|||Percent of participants||95% Confidence Interval|Number
2690217|NCT01318915|Secondary|Time From Transplant to the First Episode of Acute Rejection Requiring Treatment|Time (in days) from transplant to the start date of the first dose of treatment for acute rejection. This includes acute rejection episodes requiring treatment that are not biopsy proven.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study that had acute rejection requiring treatment.|||Days||Inter-Quartile Range|Median
2690218|NCT01318915|Secondary|Percent of Participants With Chronic T Cell-mediated or Antibody-mediated Rejection|This assessment included participants who experienced chronic T cell-mediated rejection or chronic antibody mediated rejection as well as progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy without an alternative, non-rejection-related cause.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study.|||Percent of participants||95% Confidence Interval|Number
2690219|NCT01318915|Secondary|Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade|"Biopsy-confirmed 1.) acute cellular rejection and 2.) acute antibody-mediated rejection was classified according to Banff 2007 criteria of renal allograft pathology for renal allograft rejection. A Banff result of indeterminate was not classified as rejection.~Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection is defined as a grade ≥ IA. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe.~Acute antibody-mediated rejection-or humoral rejection-is defined as a grade ≥1. Severity is graded as I, II, or III, with I being the mildest form of antibody-mediated rejection and III being the most severe."|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study.|||Biopsies|||Number
2690220|NCT01318915|Secondary|Percent of Transplanted Participants With Acute Rejection or Presumed Acute Rejection|Participants with either biopsy proven acute rejection per Banff guidelines or participants that were treated for acute rejection in the absence of a biopsy. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study.|||Percent of participants||95% Confidence Interval|Geometric Least Squares Mean
2690221|NCT01318915|Secondary|Percent of Transplant Participants Who Died|Death after receiving a kidney transplant. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study|||Percent of participants||95% Confidence Interval|Number
2690222|NCT01318915|Secondary|Percent of Transplanted Participants With Graft Loss|A participant is considered to have graft loss when the donated kidney needs to be removed, the participant is retransplanted with another donor kidney, or chronic dialysis is instituted. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study.|||Percent of participants||95% Confidence Interval|Number
2690223|NCT01318915|Secondary|Time From Completion of Immunosuppression Withdrawal to First Diagnosis of Chronic T Cell Mediated or Antibody-mediated Rejection|Time (in days) from the time the participant is off all immunosuppression to the first episode of chronic T cell mediated or chronic antibody-mediated rejection. This assessment also includes progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy without an alternative, non-rejection related cause.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs and were diagnosed with chronic rejection.||||||
2690224|NCT01318915|Secondary|Time From Completion of Immunosuppression Withdrawal to First Episode of Acute Rejection or Presumed Acute Rejection|Time (in days) from when the participant is off all immunosuppression to the first episode of biopsy proven or presumed acute rejection.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs and had acute rejection or presumed acute rejection.|||Days||Inter-Quartile Range|Median
2690225|NCT01318915|Secondary|Immunosuppression-free Duration in Days, Defined as Time From Completion of Immunosuppression Withdrawal to End of Trial Participation or to Time of Restarting Immunosuppression|Time (in days) from when the participant is off all immunosuppression to the end of trial participation or re-initiation of immunosuppression, whichever is earliest.|Transplantation through end of trial participation (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs|||Days||Inter-Quartile Range|Median
2690282|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 6|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 10 (Maintenance Period Month 6)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
2690226|NCT01318915|Secondary|Percent of Transplanted Participants Who Achieve Either Sirolimus Monotherapy or Monotherapy on a Mycophenolic Compound Within 52 Weeks Post-transplant|Participants that were treated with only sirolimus or treated with only mycophenolate mofetil (MMF) or mycophenolic acid within 52 weeks after transplantation. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks post-transplantation|Participants that received induction (Rituximab and ATG) and were transplanted on study|||Percent of participants||95% Confidence Interval|Number
2690227|NCT01318915|Secondary|Percent of Transplanted Participants Who Achieve MMF or Mycophenolic Acid Monotherapy Within 52 Weeks Post-transplant in Those Participants Intolerant of Sirolimus|Participants that were treated with only mycophenolate mofetil (MMF) or mycophenolic acid within 52 weeks after transplantation in those who could not tolerate sirolimus. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks post-transplantation|Participants that received induction (Rituximab and ATG) and were transplanted on study that could not tolerate sirolimus|||Percent of participants||95% Confidence Interval|Number
2690228|NCT01318915|Secondary|Percent of Transplanted Participants Who Achieve Sirolimus Monotherapy Within 52 Weeks Post-transplant|Participants that were treated with only sirolimus within 52 weeks after transplantation in those who could tolerant sirolimus. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks post-transplantation|Participants that received induction (Rituximab and ATG) and were transplanted on study that tolerated sirolimus|||Percent of participants||95% Confidence Interval|Number
2690229|NCT01318915|Secondary|Percent of Transplanted Participants Who Remain Off Immunosuppression for the Duration of the Study as Defined as Completion of All Schedules of Events/Followed Through August 25, 2017|Participants that remained off all immunosuppression through the completion of study participation. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through study completion (up to 4.4 years post-transplant)|Participants that received induction (Rituximab and ATG) and were transplanted on study|||Percent of participants||95% Confidence Interval|Number
2690230|NCT01318915|Secondary|Percent of Transplanted Participants Who Remain Off Immunosuppression for at Least 52 Weeks Including Those in Whom the 52 Week Biopsy Was Not Performed|Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection. A biopsy performed 52 weeks after completion of immunosuppression withdrawal confirmed that there was no sub-clinical evidence of rejection. This result considers a participant off all immunosuppression for at least 52 weeks with or without the confirmatory week 52 biopsy as a success. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks after discontinuation of all immunosuppression|Participants that received induction (Rituximab and ATG) and were transplanted on study|||Percent of participants||95% Confidence Interval|Number
2690231|NCT01318915|Primary|Percent of Participants Successfully Withdrawn From Immunosuppression and Remained Off Immunosuppression for at Least 52 Weeks|Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who failed to complete immunosuppression withdrawal, regardless of reason, or failed to have a biopsy 52 weeks after completion of immunosuppression withdrawal, were considered to have failed. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks after discontinuation of all immunosuppression|Participants that received induction (Rituximab and ATG) and were transplanted on study|||Percent of participants||95% Confidence Interval|Number
2690232|NCT01318902|Secondary|Percentage of Participants With One Year Hematologic Disease PFS|One-year survival, defined as the patient survival probability at 1 year after the date of first dose of ixazomib.|From the date of the first dose of ixazomib to the date of hematologic disease progression or death (Up to 1 year)|Safety population included all participants who received at least 1 dose of ixazomib.|||percentage of participants|||Number
2690233|NCT01318902|Secondary|Organ Disease Progression-Free Survival (PFS)|Organ disease PFS, measured as the time from the date of the first dose of ixazomib to the date of organ disease progression or death.|From the date of the first dose of ixazomib to the date of organ disease progression or death (Up to approximately 12 months)|Organ Response-Evaluable population included participants who received at least 1 cycle of ixazomib, who had amyloid involvement of at least kidney or heart at baseline, and who had at least 1 postbaseline organ response assessment.|||months||Full Range|Median
2690234|NCT01318902|Secondary|Hematologic Disease Progression-Free Survival (PFS)|Hematologic disease PFS, measured as the time from the date of the first dose of ixazomib to the date of hematologic disease progression or death.|From the date of the first dose of ixazomib to the date of hematologic disease progression or death (Up to approximately 12 months)|Safety population included all participants who received at least 1 dose of ixazomib. Data is reported for participants evaluable for this outcome measure.|||months||Full Range|Median
2690235|NCT01318902|Secondary|Time to Organ Disease Progression|Time to organ disease progression, measured as the time from the date of the first dose of ixazomib to the date of first documented organ disease progression.|From the date of the first dose of ixazomib to the date of first documented organ disease progression (Up to approximately 12 months)|Organ Response-Evaluable population included participants who received at least 1 cycle of ixazomib, who had amyloid involvement of at least kidney or heart at baseline, and who had at least 1 postbaseline organ response assessment.|||months||Full Range|Median
2690236|NCT01318902|Secondary|Time to Hematologic Disease Progression|Time to hematologic progression, measured as the time from the date of the first dose of ixazomib to the date of first documented hematologic disease progression.|From the date of the first dose of ixazomib to the date of first documented hematologic disease progression (Up to approximately 12 months)|Safety population included all participants who received at least 1 dose of ixazomib. Data is reported for participants evaluable for this outcome measure.|||months||Full Range|Median
2690283|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 5|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 9 (Maintenance Period Month 5)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
2690237|NCT01318902|Secondary|Duration of Organ Response|Duration of organ response, measured as the time from the date of first documentation of a organ response to the date of organ disease progression.|From the date of first documentation of a organ response to the date of organ disease progression (Up to approximately 12 months)|Organ Response-Evaluable population included participants who received at least 1 cycle of ixazomib, who had amyloid involvement of at least kidney or heart at baseline, and who had at least 1 postbaseline organ response assessment. Number of participants analyzed is the number of participants with data available for analyses.|||months||Full Range|Median
2690238|NCT01318902|Secondary|Duration of Hematologic Response|Duration of hematologic response, measured as the time from the date of first documentation of a hematologic response to the date of hematologic disease progression.|From the date of first documentation of a hematologic response to the date of hematologic disease progression (Up to approximately 12 months)|Hematologic response-evaluable population: all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, had >=1 postbaseline hematologic response. No participants had hematologic response for ixazomib 5.5 mg arm group thus were not analyzed. Data is reported for participants evaluable for this outcome measure.|||months||Full Range|Median
2690239|NCT01318902|Secondary|Time to First Organ Response|Time to first organ response, measured as the time from the first dose of ixazomib to the date of first documentation of a organ response.|From the date of the first dose of ixazomib to the date of first documentation of a organ response (Up to approximately 12 months)|Organ Response-Evaluable population included participants who received at least 1 cycle of ixazomib, who had amyloid involvement of at least kidney or heart at baseline, and who had at least 1 postbaseline organ response assessment.|||months||Full Range|Median
2690240|NCT01318902|Secondary|Time to First Hematologic Response|Time to first hematologic response, measured as the time from the first dose of ixazomib to the date of first documentation of a hematologic response.|From the date of the first dose of ixazomib to the date of first documentation of a hematologic response (Up to approximately 12 months)|Hematologic response-evaluable population: all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, had >=1 postbaseline hematologic response. No participants had hematologic response for ixazomib 5.5 mg arm group thus were not analyzed. Data is reported for participants evaluable for this outcome measure.|||months||Full Range|Median
2690241|NCT01318902|Secondary|Number of Participants With Best Hematologic Response to Treatment Based on Investigators Assessment|The overall hematologic response rate is defined as number of participants with complete response (CR) or partial response (PR) or very good partial response (VGPR) as assessed by the investigator. Response is determined according to standardized criteria using a central laboratory. CR=serum and urine negative for monoclonal protein by immunofixation; or free light chain ratio normal; < 5% plasma cells in bone marrow without clonal dominance. PR=reduction in dFLC > 50%. VGPR= dFLC < 40 mg/L.|Day 22 to 28 in each cycle and end of treatment visit; then every 6 weeks thereafter until disease progression or initiation of subsequent antineoplastic therapy (Up to approximately 12 months)|Hematologic response-evaluable population included all participants who received at least 1 cycle of ixazomib, had measureable disease at baseline, and had at least 1 postbaseline hematologic response assessment.|||Participants|||Count of Participants
2690242|NCT01318902|Secondary|Number of Participants With Best Organ Response to Treatment Based on Investigators Assessment|Organ response rate was estimated as the number of participants with documented organ response (ie. Heart or kidney ). Treatment response of amyloid-related organs were identified based on national cancer institute, common terminology criteria for adverse events (NCI CTCAE) Version 4.02 criteria.|At Cycles 3, 6, 9, and 12; every 6 months thereafter until disease progression or the initiation of subsequent antineoplastic therapy and at end of treatment (EOT) visit (Up to approximately 12 months)|Organ response-evaluable population included all participants who received at least 1 cycle of ixazomib, had amyloid involvement of at least kidney or heart at baseline, and had at least 1 postbaseline organ response assessment.|||Participants|||Count of Participants
2690243|NCT01318902|Secondary|AUE0-168: Area Under Effect Curve of Whole Blood 20S Proteasome Inhibition From Zero to Concentration at 168 Hours for Ixazomib||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|PD analysis population: all participants who received at least 1 dose of ixazomib and had whole blood 20S proteasome inhibition-time data and dosing data to permit calculation of PD parameters. Data was only collected for ixazomib 4.0 mg arm group. Number analyzed is number of participants with evaluable data at given time-point.|||hr*percentage of inhibition||Standard Deviation|Mean
2690244|NCT01318902|Secondary|TEmax: Time to Maximum Observed Effect (Emax) of Whole Blood 20S Proteasome Inhibition for Ixazomib||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|PD analysis population: all participants who received at least 1 dose of ixazomib and had whole blood 20S proteasome inhibition-time data and dosing data to permit calculation of PD parameters. Data was only collected for ixazomib 4.0 mg arm group. Number analyzed is number of participants with evaluable data at given time-point.|||hours||Full Range|Median
2690245|NCT01318902|Secondary|Emax: Maximum Observed Percent Inhibition of Whole Blood 20S Proteasome||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|Pharmacodynamic (PD) analysis population: all participants who received at least 1 dose of ixazomib and had whole blood 20S proteasome inhibition-time data and dosing data to permit calculation of PD parameters. Data was only collected for ixazomib 4.0 mg arm group. Number analyzed is number of participants with evaluable data at given time-point.|||percentage of inhibition||Standard Deviation|Mean
2690246|NCT01318902|Secondary|AUC0-168: Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Post-dose for Ixazomib||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|PK analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||hr*ng/mL||Full Range|Mean
2690247|NCT01318902|Secondary|Ctrough: Plasma Concentration Immediately Prior to Dosing for Ixazomib||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|PK analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng/mL||Full Range|Mean
2690248|NCT01318902|Secondary|Tmax: Time of First Occurrence of Cmax for Ixazomib||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|PK analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||hours||Full Range|Median
2690249|NCT01318902|Secondary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr|Pharmacokinetic (PK) analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng/mL||Full Range|Mean
2690250|NCT01318902|Primary|Recommended Phase 2 Dose (RP2D) of Ixazomib|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1). The RP2D of Ixazomib was determined in dose escalation group on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) data observed in Cycle 1.|Cycle 1 (28 days)|DLT-evaluable population included all participants who received all Cycle 1 doses of ixazomib or experienced a DLT in Cycle 1.|||mg|||Number
2690251|NCT01318902|Primary|Maximum Tolerated Dose (MTD) of Ixazomib|MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT). DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events, v 4.03 as: Grade 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >7 days;Grade 3 neutropenia with fever or infection;Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding;platelet count <10,000/mm^3;Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy;Grade 3 QTc prolongation (QTc >500 msec);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia;or <1 week Grade 3 fatigue;delay in initiation of the subsequent therapy cycle by >2 weeks;other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation, considered possibly related to therapy as assessed by Investigator.|Cycle 1 (28 days)|DLT-evaluable population included all participants who received all Cycle 1 doses of ixazomib or experienced a DLT in Cycle 1.|||mg|||Number
2690252|NCT01318902|Primary|Number of Participants With Peripheral Neuropathy Reported as a TEAE|Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.|From the first dose of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2690253|NCT01318902|Primary|Number of Participants With Clinically Significant Abnormal Laboratory Values Reported as TEAE|The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis. Abnormal laboratory values were assessed as an AE if that value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline.|From the first dose of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2690254|NCT01318902|Primary|Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.|From the first dose of study drug plus 30 days after last dose of study drug or until the initiation of subsequent antineoplastic therapy (Up to approximately 13 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2690255|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8 and 29||||participants|||Number
2690256|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation||at day 8 and 29||||participants|||Number
2690257|NCT01318811|Secondary|Number of Major Bleeding Complications|Information on major bleeding complications, and need for blood product transfusions will be collected.|72 hours|includes all that started study|||clinical active major bleeding episodes|||Number
2690258|NCT01318811|Primary|Filter Life|The primary endpoint for this study will be the difference in filter life in hours between the group receiving dilute heparin and the group receiving standard concentrated heparin.|72 hours|analysis does not include those that had dialysis stopped before end of filter life|||hours||Standard Deviation|Mean
2690259|NCT01318733|Primary|Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.|"Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema~/ Almost clear; slight redness~/ Mild erythema; definite redness~/ Moderate erythema; marked redness~/ Severe erythema; fiery redness~Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1."|Over 1 year||||scores on a scale||Standard Deviation|Mean
2690260|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data|||percentage of participants|||Number
2690261|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data|||percentage of participants|||Number
2690262|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks|"Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).~Participants with multiple abnormalities were counted only once in the worst category."|within 48 weeks|Participants in the Safety Set with available data|||percentage of participants|||Number
2690263|NCT01318694|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks|"ALT abnormalities were summarized as participants who had either:~ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline~ALT > 3 x ULN during the study and > 2 x ULN at baseline"|within 48 weeks|Participants in the Safety Set, defined as having received at least one dose of study medication, with available data|||percentage of participants|||Number
2690264|NCT01318694|Secondary|Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks|ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).|at treatment end within 48 weeks|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690265|NCT01318694|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment|eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.|from 4 to 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690266|NCT01318694|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment|cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690267|NCT01318694|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment|pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690268|NCT01318694|Secondary|Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment|EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690269|NCT01318694|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)|RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.|after 4 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690270|NCT01318694|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks after the end of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
2690271|NCT01318694|Primary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
2690272|NCT01318538|Secondary|Change in Mean Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day. Drinks per drinking day was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drinks per drinking day. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||change in mean drinks per drinking day||95% Confidence Interval|Mean
2690273|NCT01318538|Secondary|Percent Change in Mean Heavy Drinking Days for Women|This represents the percent change from baseline in the mean number of heavy drinking days for women. Number of heavy drinking days was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean heavy drinking days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||% change in mean heavy drinking days||95% Confidence Interval|Mean
2690284|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 8 (Maintenance Period Month 4)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
2690274|NCT01318538|Secondary|Percent Change in Mean Drug Use Days for Women|This represents the percent change from baseline in the mean number of drug use days (excluding alcohol) for women. Days of drug use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drug use days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||% change in mean drug use days||95% Confidence Interval|Mean
2690275|NCT01318538|Other Pre-specified|Group Stability|Treatment group stability was calculated using the Percentage of Group Change Index which captures change in group membership composition from session to session separately for each individual within each group (specific to the calendar period that each person was in the group). The value can range from 0 (i.e., the exact same membership from one session to the next) to 1 (i.e., complete turnover in membership). The average values across all sessions were taken to get an overall sense of the amount of turnover each person experienced in the group during the period in calendar time they were in treatment.|In treatment (weeks 1-12)|Only women were included in this analysis.|||units on a scale||Standard Deviation|Mean
2690276|NCT01318538|Other Pre-specified|Group Attendance|Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12.|In treatment (weeks 1-12)|Only women were included in this analysis.|||sessions attended||Standard Deviation|Mean
2690277|NCT01318538|Other Pre-specified|Therapist Adherence|All therapists were female to eliminate any therapist-patient gender matching effects. There were eight therapists in total: 4 who led WRG groups and 4 who led GDC groups. All group sessions were videotaped each week so that we could measure therapist adherence to the treatment they were assigned to. Two independent raters completed adherence scales for a random selection of 20% of WRG and 10%of GDC sessions. For both groups, the extensiveness to which the therapist engaged in a behavior during the session was rated with a 5-point Likert scale (0 = not at all; 4 = extensively). Adherence scores were calculated by averaging all scores for each question (25 questions for WRG; 18 for GDC) on the measure. The scores reported here represent the average of all WRG therapists scores from all session, and all GDC therapist scores from all sessions. Scores range from 0 to 4.|In treatment (weeks 1-12)||||units on a 0-4 adherence scale|Sessions|Standard Deviation|Mean
2690278|NCT01318538|Primary|Change in Mean ASI Drug Composite Score for Women|"This represents the change from baseline in mean ASI Drug composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.~The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems."|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||change in ASI Drug composite score||95% Confidence Interval|Mean
2690279|NCT01318538|Primary|Change in Mean ASI Alcohol Composite Score for Women|"This represents the change from baseline in mean ASI Alcohol composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.~The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems."|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||change in ASI Alcohol composite score||95% Confidence Interval|Mean
2690280|NCT01318538|Secondary|Percent Change in Mean Alcohol Use Days for Women|This represents the percent change from baseline in the mean number of alcohol use days. Days of alcohol use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline alcohol use data. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Some participants did not complete this measure at the specified time points. Only women were included in this analysis.|||percent change in Alcohol Use Days||95% Confidence Interval|Mean
2690281|NCT01318538|Primary|Percent Change in Mean Days of Any Substance Use for Women|This represents the percent change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol) for women. Days of substance use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean days of any substance use. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||% change in mean substance use days||95% Confidence Interval|Mean
2690291|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 1|The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.|Month 1|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
2690292|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Maintenance Period|The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA|Month 5, 6, 7, 8, 9, 10|All participants who received at least one dose of MIRCERA during maintenance period.|||g/L||Standard Deviation|Mean
2690293|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Titration Period|The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.|Baseline, Month 1, 2, 3, 4|All participants who received at least one dose of MIRCERA during titration period.|||g/L||Standard Deviation|Mean
2690294|NCT01318512|Primary|Average Dose of MIRCERA at Entry Level|The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.|Baseline|All participants who received at least one dose of MIRCERA during the titration period.|||microgram (µg)||Standard Deviation|Mean
2690295|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Pain Free by Visit|Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
2690296|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Cured by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
2690297|NCT01318499|Post-Hoc|Cumulative Percent Clinical Success by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one post-operative assessment (intent-to-treat).|||Percentage of patients|||Number
2690298|NCT01318499|Secondary|Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 7 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
2690299|NCT01318499|Primary|Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 14 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
2690300|NCT01318408|Other Pre-specified|Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated|Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Were Planned to be Examined.|12 weeks|||||||
2690301|NCT01318408|Primary|ADAS-cog at Baseline and at 3 Months.|"ADAScog (Alzheimer's Disease Assessment Scale-cognitive subscale) consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Score ranges from 0 - 70.~Lower scores (negative change) indicate improvements on the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog)."|Baseline and Three (3) months||||units on a scale||Standard Deviation|Mean
2690302|NCT01318408|Primary|MMSE at Baseline and at Three (3) Months.|The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Baseline and Three months||||units on a scale||Standard Deviation|Mean
2690339|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690303|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.|||percentage of participants||95% Confidence Interval|Number
2690304|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 1 minute prior to tracheal extubation|The Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.|||percentage of participants||95% Confidence Interval|Number
2690305|NCT01318382|Secondary|Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.|||percentage of participants||95% Confidence Interval|Number
2690306|NCT01318382|Primary|Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 1 minute prior to tracheal extubation|Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.|||percentage of participants||95% Confidence Interval|Number
2690307|NCT01318278|Secondary|All Cause Mortality||admission to hospital discharge, up to 15 months||||participants|||Number
2690308|NCT01318278|Secondary|Presence of Bronchopulmonary Dysplasia (BPD)|Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD|36 weeks postmenstrual age||||participants|||Number
2690309|NCT01318278|Secondary|Retinopathy of Prematurity Stage 3 or Higher|"All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis.~Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages."|Until hospital discharge, up to 15 months||||participants|||Number
2690310|NCT01318278|Secondary|Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound||Until hospital discharge, up to 15 months||||participants|||Number
2690311|NCT01318278|Secondary|Presence of Patent Ductus Arteriosus (PDA)||until hospital discharge, up to 12 weeks||||participants|||Number
2690312|NCT01318278|Secondary|Ventilator Days||Until hospital discharge, up to 15 months||||days||Inter-Quartile Range|Median
2690313|NCT01318278|Secondary|Necrotizing Enterocolitis||until hospital discharge, up to 12 weeks||||participants|||Number
2690314|NCT01318278|Secondary|Evidence of Ischemic Changes|Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.|96 hours or until medication completely stopped||||participants|||Number
2690315|NCT01318278|Secondary|Urine Output||96 hours or until hypotension resolved and medication completely stopped||||ml/kg/hr||Standard Deviation|Mean
2690316|NCT01318278|Secondary|Hyponatremia||96 hours or until medication completely stopped||||participants|||Number
2690317|NCT01318278|Secondary|Acid-base Status||96 hours or until hypotension resolved and medication completely stopped|Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases|||pH||Standard Deviation|Mean
2690318|NCT01318278|Secondary|Heart Rate Change From Baseline|Heart rate change from baseline during study drug administration|96 hours or until hypotension completely resolved and medications stopped|This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.|||beats per minute||Standard Deviation|Mean
2690340|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690319|NCT01318278|Primary|Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life|Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP|24 hours of life|This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.|||participants|||Number
2690320|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690321|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690322|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690323|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690324|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690325|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690326|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690327|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690328|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690329|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690330|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690331|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690332|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690333|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690334|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690335|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690336|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690337|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to 52).|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690338|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690341|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690342|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690343|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690344|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690345|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690346|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690347|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690348|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690349|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690350|NCT01318135|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.|||participants|||Number
2690351|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690352|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690353|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690354|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690355|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690362|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690363|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690364|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690365|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690366|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690367|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690368|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690369|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690370|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690371|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690372|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690373|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690374|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690375|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690376|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690377|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690378|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690379|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690380|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690381|NCT01318122|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.|||participants|||Number
2690382|NCT01318109|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690383|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690384|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690385|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690386|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690387|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690388|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690389|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690390|NCT01318109|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690391|NCT01318083|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690392|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690437|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable post-CYP17i patients with bone metastasis at baseline|||participants|||Number
2690393|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690394|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690395|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690396|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690397|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690398|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690399|NCT01318083|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690400|NCT01318070|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690401|NCT01318070|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690402|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690403|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690404|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690405|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2690406|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690407|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690408|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2690409|NCT01318018|Primary|Recovery Time|recovery time from seizure induction to eye opening / restoration of breathing|same day||||minutes||Standard Deviation|Mean
2690410|NCT01317901|Primary|Response|Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 15 and Day 28 of even-numbered cycles|All treated subjects|||participants|||Number
2690411|NCT01317797|Secondary|Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)|Ritchie articular index (RAI); a joint count that grades the tenderness of 26 joints on a scale of 0-3); the number of swollen joints from 44 joints (swollen44); ESR in mm/hour after 1 hour and the patient's global disease activity on a Visual Analogue Scale (VAS) of 100 mm (0=no disease activity to right end of the line 100=maximum disease activity) were used to calculate DAS44-ESR using the following formula: DAS44-ESR = 0.54*sqrt(RAI) + 0.065*(swollen44) + 0.33*ln(ESR) + 0.0072*VAS. Lower numbers were better. A negative change from Baseline indicated improvement.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.|||score on a scale||Standard Deviation|Mean
2690412|NCT01317797|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.|||percentage of participants|||Number
2690413|NCT01317797|Secondary|Number of Participants With Anti-MT203 Antibodies|Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690414|NCT01317797|Secondary|Change From Baseline in MT203/GM-CSF Complexes in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118|All randomized participants with data available for analysis.|||pg/mL||Standard Deviation|Mean
2690415|NCT01317797|Secondary|Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118|All randomized participants with data available for analysis.|||pg/mL||Standard Deviation|Mean
2690416|NCT01317797|Secondary|Ctrough: Maximum Observed Plasma Concentration Pre-Dose||Days 1, 15 and 29 Pre-dose|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||μg/mL||Full Range|Geometric Mean
2690417|NCT01317797|Secondary|Terminal Phase Elimination Half-life (T1/2) for MT203|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated.|||days||Full Range|Mean
2690418|NCT01317797|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||day*μg/mL||Full Range|Geometric Mean
2690419|NCT01317797|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||day*μg/mL||Full Range|Geometric Mean
2690420|NCT01317797|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||day*μg/mL||Full Range|Geometric Mean
2690421|NCT01317797|Secondary|Cmax: Maximum Observed Plasma Concentration for MT203|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||μg/mL||Full Range|Geometric Mean
2690422|NCT01317797|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)||||days||Full Range|Median
2690423|NCT01317797|Primary|Number of Participants Reporting One or More Treatment Emergent Adverse Events|An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690424|NCT01317797|Primary|Number of Participants With Clinically Significant Physical Examination Findings|The physical examination included body system assessments: eyes, head and neck (including thyroid), ears, nose and throat, lymph nodes, cardiovascular, lungs, mammae, abdomen (liver, spleen), genitals, limbs, central and peripheral nervous system, musculoskeletal system, skin & nails, mucosae. The Investigator classified abnormal findings as either clinically significant or not clinically significant.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690425|NCT01317797|Primary|Number of Participants With Clinically Significant Pulmonary Function Tests|Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690426|NCT01317797|Primary|Number of Participants With Clinically Significant Vital Signs|Vital signs included Systolic Blood Pressure (BP), Diastolic BP, body temperature, heart rate. Alert values were: BP systolic > 170 mmHg or < 85 mmHg, BP diastolic > 105 mmHg, Difference BP systolic vs. Baseline (pre-treatment) > 40 mmHg or Pulse rate < 35 bpm or > 120 beats per minute (bpm).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690427|NCT01317797|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Alert values for ECG were: Heart rate < 35 bpm or > 120 bpm, QTc acc. to Bazett (absolute value)> 500 ms or QTc acc. to Bazett (increase versus Baseline (pre-treatment).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690428|NCT01317797|Primary|Number of Participants With Clinically Significant Clinical Laboratory Results|Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): > 3 times upper limit of normal (ULN). Creatinine and Glucose: > 2 times ULN. Potassium > 6.0 or < 3.0 mmol/L. Haemoglobin: Male < 8.0 ;Female < 7.0 g/dL. Erythrocytes :Male < 3.5 x 10^12/L or > 7 x 10^12/L;Female < 3.0 x 10^12/L or > 6.5 x 10^12/L. White Blood Cells (WBC): < 2.8 x10^9/L or > 16.0 x 10^9/L. Eosinophils > 20 % of cells in the WBC differential. Platelet Count < 75 x 10^9/L or 600 x 10^9/L. No alert values were identified for Coagulation or Urinalysis.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
2690429|NCT01317667|Secondary|Over Response Rates and Comparisons for ELISA and TNA Titers|Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion.|Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12|Per-protocol population. Only observations or specimens collected according to the protocol were included in the immunogenicity analyses.|||participants|||Number
2690430|NCT01317667|Primary|Number of Vaccinated Subjects Any Averse Events and by Location and Severity||Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months|Safety population: any subject receiving a vaccination|||participants|||Number
2690431|NCT01317641|Secondary|Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1||1 day|PK population (Day 1)|||h||Standard Deviation|Median
2690432|NCT01317641|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state||Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||ng/mL||Standard Deviation|Mean
2690433|NCT01317641|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state|AUC(0-8h)|Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||h*ng/mL||Standard Deviation|Mean
2690434|NCT01317641|Secondary|Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1||1 day|PK population (Day 1)|||h||Standard Deviation|Median
2690438|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline|||participants|||Number
2690439|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline|||participants|||Number
2690440|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Post-CYP17i patients|||participants|||Number
2690441|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Post-chemotherapy and CYP17i-naïve patients|||participants|||Number
2690442|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Chemotherapy-naïve and CYP17i-naïve patients|||participants|||Number
2690443|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor|3 months|Evaluable post-CYP17 inhibitor patients|||participants|||Number
2690444|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor|3 months|Evaluable post-chemotherapy and CYP17i-naïve patients|||participants|||Number
2690445|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor|3 months|Evaluable chemotherapy-naïve and CYP17i-naïve patients|||participants|||Number
2690446|NCT01317641|Primary|Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose|The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)|Up to 28 days for each cohort|Safety population included all participants in Phase 1 who received any study drug.|||DLTs|||Number
2690447|NCT01317641|Primary|Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)|A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.|Up to 28 days for each cohort|Safety population included all participants in Phase 1 who received any study drug.|||events|||Number
2690448|NCT01317615|Secondary|Overall Survival (OS)|OS was defined as the time from date of start of treatment to date of death due to any cause.|12 months|All participants were included in the analysis.|||Days||95% Confidence Interval|Median
2690449|NCT01317615|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.|6 months|All participants were included in the analysis.|||Days||95% Confidence Interval|Median
2690450|NCT01317615|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.|||Percentage of participants|||Number
2690451|NCT01317615|Secondary|Percentage of Participants With Overall Response Rate (ORR)|ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.|3 months|All participants were included in the analysis.|||Percentage of participants|||Number
2690466|NCT01317160|Secondary|Venous Thromboembolic Events (VTE)|"At 6 weeks postoperatively the number of participants with VTE events will be assessed by:~1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|6 weeks||||participants|||Number
2690467|NCT01317160|Secondary|Functional Outcome - Muscular Endurance Tests (Heel-rise)|The functional outcome will be assessed at 52 weeks post-operatively by validated muscular endurance test, i.e. heel rise test.|one year|||||||
2690452|NCT01317615|Secondary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|All participants were included in the analysis.|||Percentage of participants|||Number
2690453|NCT01317615|Primary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.|||Percentage of participants|||Number
2690454|NCT01317550|Primary|Primary Outcome Variable: Combined AUC of Selected Symptoms Fatigue, Pain, Disturbed Sleep, Lack of Appetite and Drowsiness|Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.|During 10 weeks of CXRT|Of the 14 randomized patients, 12 (85% were evaluable for the primary efficacy analysis).|||Units on a scale week||Standard Deviation|Mean
2690455|NCT01317472|Primary|Change in Reflux Symptom Index (RSI)|The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of >13 is considered to be abnormal.|Baseline to 2 months||||units on a scale||Standard Deviation|Mean
2690456|NCT01317199|Secondary|(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline|Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL|At month 12 post-intervention|Patients counted in the analysis were evaluable if they completed at least six cycles of treatment prior to discontinuation|||Participants|||Count of Participants
2690457|NCT01317199|Secondary|(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%||At month 12 post-intervention|Data was not collected for this secondary outcome measure.||||||
2690458|NCT01317199|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events reported verbally by patient and documented in study notes.|At month 12 post-intervention||||Participants|||Count of Participants
2690459|NCT01317199|Primary|(Phase II) Prostate Specific Antigen Doubling Time (PSADT)|To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.|Change from baseline to month 12||||months||Full Range|Median
2690460|NCT01317199|Primary|(Phase I) Maximum Tolerated Dose|To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.|Up to 7 months post-intervention||||mg|||Number
2690461|NCT01317160|Other Pre-specified|Surgeon Experience|Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. The experienced group of surgeons will consist of specialists accredited with a specialist licence issued by The Swedish National Board of Health and Welfare. The less experienced group of surgeons will consist of residents.|Surgery will be performed within 10 days of injury||2020-06-30|06/2020||||
2690462|NCT01317160|Other Pre-specified|Surgeon Sex|Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. Unknown sex of the operating surgeon will be included as an additional exclusion criterion in the study.|Surgery will be performed within 10 days of injury||2020-06-30|06/2020||||
2690463|NCT01317160|Secondary|Time From Injury to Surgery|"Prognostic factor:~Time to surgery , i.e. the time from ATR injury to start of the surgical procedure, will be calculated by using the time-point at which the patient sustained the injury as described in the patient journal, as well as the starting time point of the surgery as registered in the computerized operation report."|1 year||2020-06-30|06/2020||||
2690464|NCT01317160|Secondary|Microdialysis|At 2 weeks postoperatively in-vivo microdialysis will be performed on as described by Greve et al 2012 (DOI: 10.1111/j.1600-0838.2012.01475.x). In the microdialysate different substances will be assessed, eg. markers of tendon callus production, procollagen type I (PINP) and type III (PIIINP) N-Terminal propeptide by enzymatic quantification.|2 weeks|||||||
2690465|NCT01317160|Secondary|Patient-reported Outcome and Physical Activity|The patients' symptoms and physical activity levels will be assessed using four reliable and valid scores; the Achilles tendon Total Rupture Score (0-100, 100=best), Physical Activity scale (1-6, 6=best), Foot and Ankle Outcome Score (0-100, 100=best) and EuroQol Group's questionnaire (0-100, 100=best).|One year||2019-12-31|12/2019||||
2690468|NCT01317160|Primary|Venous Thromboembolic Events (VTE)|"At 2 weeks postoperatively the number of participants with VTE events will be assessed by:~1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|2 weeks|Non-compliance was defined by exposure to less than ten hours of IPC. Therefore, two patients were withdrawn on this basis and the treatment group comprised 67 patients at final analysis.|||participants|||Number
2690469|NCT01317095|Secondary|Postop Length of Hospital Stay.|Postoperative length of hospital stay.|Until hospital discharge|Postoperative length of hospital stay.|||days||Standard Deviation|Mean
2690470|NCT01317095|Secondary|Length of ICU Stay|Length of postoperative intensive care unit stay.|ICU stay|Postoperative average intensive care unit stay (hours)|||hours||Standard Deviation|Mean
2690471|NCT01317095|Secondary|Pain Scores.|One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.|5 days after surgery|Likert Pain Scale from 0-10 (0: no pain; 10:worst possible pain)|||score on a scale||Standard Deviation|Mean
2690472|NCT01317095|Primary|Intubation Time|The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure|48 hours after surgery|Intubation time|||hours||Standard Deviation|Mean
2690473|NCT01317030|Primary|Hyaluronan Levels|Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers.|7 days following lens insertion|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||ng/mL||Standard Error|Mean
2690474|NCT01317004|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.|6 months|Participants from the safety set, who had values at month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2690475|NCT01317004|Secondary|Change From Baseline in Patient-reported Health Related Quality of Life (QOL)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2690476|NCT01317004|Secondary|Change From Baseline in Patient-reported Depression|The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2690477|NCT01317004|Secondary|Change From Baseline in Patient-Reported Effectiveness and Convenience|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2690478|NCT01317004|Secondary|Change From Baseline in Patient-reported Fatigue|The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2690479|NCT01317004|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL)|The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2690480|NCT01317004|Primary|Change From Baseline in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2690481|NCT01316939|Secondary|Change From Baseline in Faecal Calprotectin at Weeks 28 and 52|Stool sample for faecal calprotectin were to be collected at Weeks 28 and 52 visit if applicable. Data for Change from baseline in faecal calprotectin at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in faecal calprotectin at Weeks 28 and 52 was not collected.||||||
2690482|NCT01316939|Secondary|Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52|C-reactive protein (CRP) at was to be assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 visit if applicable. Data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0 and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected.||||||
2690483|NCT01316939|Secondary|Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52|Healthcare related resource utilization was to include: Hospitalizations (all cause and Crohn's disease related), Length of stay, Surgical procedures (all cause and Crohn's disease related), Outpatient visits (all cause and Crohn's disease related ). The frequency of hospitalizations, surgical procedures and hospital out-patient visits were to be recorded at Weeks 28 and 52. The number and percentage of participants reporting all cause and Crohn's disease -related hospitalizations, surgeries, and hospital out-patient visits were to be summarized and compared between each GSK1605786A dose group and placebo using Fisher's exact test. Data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected.||||||
2690484|NCT01316939|Secondary|Receipt of Disability Benefits at Weeks 28 and 52|Receipt of disability benefits (Yes/No) was to be recorded at Weeks 0, 28 and 52 and Early Withdrawal visit if applicable. Change from baseline in receipt of disability benefits was to be compared between participants in remission versus participants not in remission using a Wilcoxon rank sum test. Data for Receipt of disability benefits at Weeks 28 and 52 was not collected following early termination of this study.|Weeks 28 and 52|ITT population. Following early termination of study CCX114157 data for Receipt of disability benefits at Weeks 28 and 52 was not collected.||||||
2690485|NCT01316939|Secondary|Change From Baseline in Work Productivity & Activity Impairment - Crohn's Disease (WPAI-CD) at Weeks 28 and 52|WPAI measures the effect of your CD on your ability to work and perform regular activities. 6-items assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID). Data for change from Baseline in WPAI-CD at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in Work productivity & activity impairment – Crohn’s disease (WPAI-CD) at Weeks 28 and 52 was not collected.||||||
2690486|NCT01316939|Secondary|Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52|EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). Data for Change from Baseline in EuroQol five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in European Quality of Life (EuroQol ) five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected.||||||
2690543|NCT01316770|Secondary|Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) to Study Day 14|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2694957|NCT01283282|Secondary|Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)|High-sensitivity C-reactive protein (hsCRP) was measured. The hsCRP levels were measured by Dade Behring nephelometry.|Week 12||||mg/L||Standard Error|Mean
2690487|NCT01316939|Secondary|Change From Baseline in Short Form - 36 Version 2 (SF-36 v2) at Weeks 28 and 52|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 v2 items are scored such that a higher score indicates a better health state and better functioning. Data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected.||||||
2690488|NCT01316939|Secondary|Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52|A 12 lead ECG was collected at Weeks 28 and 52. ECG abnormalities were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). A-NCS data for Week 28 and 52 have been presented.|Week 28 and 52|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2690489|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Alanine Amino Transferase, Aspartate Amino Transferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Liver function test parameters included alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.|||units per liter||Standard Deviation|Mean
2690490|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Liver function test parameter included albumin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
2690491|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Total Bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.|Liver function test parameter included total bilirubin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.|Safety Population. Only those participants available at the specified time points were analyzed|||micromoles per liter||Standard Deviation|Mean
2690492|NCT01316939|Secondary|Number of Participants With Shift From Baseline in Clinical Chemistry Parameters|Clinical chemistry parameters included total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma glutamyl transferase, total bilirubin, direct bilirubin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, blood urea nitrogen (BUN)/Urea, creatinine, uric acid, lactate dehydrogenase, bicarbonate, cholesterol and creatinine kinase. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in clinical chemistry parameters characterized as high and low have been presented.|Upto Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2690493|NCT01316939|Secondary|Number of Participants With Shift From Baseline in Hematology Parameters|Hematology parameters included platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hematocrit, red blood cell count, hemoglobin, white blood cell count and segmented neutrophils . Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44 and 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in hematology parameters characterized as high and low have been presented.|Upto Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2690494|NCT01316939|Secondary|Change From Baseline in Vital Sign Heart Rate Upto Week 56|Vital sign assessment included heart rate collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
2690495|NCT01316939|Secondary|Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56|Vital sign assessments included SBP and DBP collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and Week 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2690544|NCT01316770|Secondary|Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale|Possible response on nominal scale: Inactive; Low; Moderate; High SDAI.|Baseline (Study Day 0) to Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690496|NCT01316939|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Upto 56 weeks|The Safety Population comprised of all participants in the ITT population except those who did not take at least one dose of investigational product.|||Participants|||Count of Participants
2690497|NCT01316939|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52|The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The IBDQ questionnaire was to be completed by each participant at baseline and at Weeks 28, and 52. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Week 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52 was not collected.||||||
2690498|NCT01316939|Secondary|Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52|The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores and changes in CDAI scores during the 52-week treatment period were to be summarized by treatment group at Weeks 4, 8, 12, 20, 28, 36, 44, and 52. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52 was not collected.||||||
2690499|NCT01316939|Secondary|Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline|The duration of time participants maintained clinical remission during the 52-week treatment period was to be defined as the time between Week 0 and the first visit where remission was not observed in those participants in remission at baseline. These time periods were to be summarized by treatment group using quartiles and their corresponding confidence intervals. Comparisons between each GSK1605786A dose group and placebo were to be made using log-rank tests. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.|Upto Week 52|ITT Population. Following early termination of study CCX114157 data for Time to induction of clinical remission in participants who had achieved clinical response during induction therapy but were not in clinical remission at Baseline was not collected.||||||
2690500|NCT01316939|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical response is defined as a reduction from the induction study baseline CDAI score of >=100 points. The percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-week maintenance treatment period in the ITT population using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher's exact test. Participants with missing CDAI scores were to be considered non-responders according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.|Week 28 and 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants with a clinical response (CDAI decrease >=100 points) at both Weeks 28 and 52 of the 52-week treatment period was not collected.||||||
2690501|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at Week 52|The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.|Week 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at Week 52 was not collected.||||||
2690502|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at All Visits (Continuous Clinical Remission) During the 52-week Treatment Period Among Participants in Clinical Remission at Baseline|The percentage of participants with clinical remission at all visits during the 52-week treatment period were to be summarized by treatment group for the subset of participants in remission at baseline, using the no effect imputation for missing data. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. Comparisons between each GSK1605786A dose group and placebo were to be made using Fisher's exact test.The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.|Upto Week 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-week treatment period among participants in clinical remission at Baseline was not collected.||||||
2690503|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at Both Weeks 28 and 52 of the 52-week Treatment Period Among Those Participants Who Were in Clinical Remission at Baseline|Clinical remission is defined as a CDAI score <150 points. Among participants in remission at baseline, the percentage of participants with clinical remission at both Weeks 28 and 52 of the treatment period using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher's exact test. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn's disease.|Week 28 and 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-week treatment period among those participants who were in clinical remission at Baseline was not collected.||||||
2690504|NCT01316939|Secondary|Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical remission is defined as a CDAI score <150 points. A participant was considered to be not taking corticosteroids at Weeks 28 and 52 if the participant had not taken a corticosteroid for the 8 days prior to and the day of the CDAI assessment for each of Weeks 28 and 52. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period have been presented.|Week 28 and 52|ITT Population.|||Percentage of Participants|||Number
2690505|NCT01316939|Primary|Percentage of Participants in Clinical Remission (Crohn's Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical remission is defined as a CDAI score <150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.|Week 28 and 52|The Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment who achieved a clinical response (CDAI decrease from baseline of >=100 points) or achieved clinical remission (CDAI <150 points).|||Percentage of Participants|||Number
2690506|NCT01316926|Primary|Cmax_steady-state|"Cmax_steady-state (ss) is defined as the maximum or peak concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed."|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
2690507|NCT01316926|Primary|Cmin_steady-state|Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
2690508|NCT01316926|Primary|Area Under the Curve_steady-state|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_steady-state (ss) is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study|||ng/h/ml||Standard Deviation|Mean
2690509|NCT01316913|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
2690510|NCT01316913|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690545|NCT01316770|Secondary|Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690511|NCT01316913|Primary|Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.|Baseline and Day 169|ITT Population: all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690512|NCT01316900|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population excluding participants from Investigator 040688. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2690513|NCT01316900|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population excluding participants from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690514|NCT01316900|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants. .|Baseline and Day 169|ITT Population excluding par. from Investigator 040688: all randomized par. who received >=1 dose of study drug, except for those from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690515|NCT01316887|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning's dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions.|Baseline; Months 1, 3, 6, 9, and 12|ITT Population. The overall number of participants reflects all participants who provided at least one post-treatment assessment. Participants who provided data the specified time points are represented by n=X, X, X in the category titles.|||Liters||Standard Error|Least Squares Mean
2690516|NCT01316887|Secondary|Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period|Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline.|From the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the summary.|||Percentage of rescue-free days||Standard Deviation|Mean
2690517|NCT01316887|Secondary|Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period|Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group.|Baseline; from the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the analysis.|||Number of puffs per day||Standard Error|Least Squares Mean
2690518|NCT01316887|Secondary|Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation|"Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An any time post-Baseline Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists."|Screening; from the start of study drug up to 52 weeks|ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized.|||Participants|||Number
2690519|NCT01316887|Secondary|Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline|Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists.|From the start of study drug up to 52 weeks|ITT Population|||participants|||Number
2690520|NCT01316887|Secondary|Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Beats per minute||Standard Deviation|Mean
2690521|NCT01316887|Secondary|Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Milliseconds||Standard Deviation|Mean
2690522|NCT01316887|Secondary|Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Beats per minute||Standard Deviation|Mean
2690523|NCT01316887|Secondary|Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2690524|NCT01316887|Secondary|Change From Baseline in Hematocrit at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2690525|NCT01316887|Secondary|Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2700363|NCT01243320|Secondary|Mean Change in Diastolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmhg||95% Confidence Interval|Mean
2690526|NCT01316887|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Percentage in blood||Standard Deviation|Mean
2690527|NCT01316887|Secondary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2690528|NCT01316887|Secondary|Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2690529|NCT01316887|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2690530|NCT01316887|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2690531|NCT01316887|Secondary|Time to the First On-treatment COPD Exacerbation|An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants.|From the start of study drug up to 52 weeks|ITT Population|||Days||Full Range|Median
2690532|NCT01316887|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period|A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.|From the start of study drug up to 52 weeks|ITT Population|||Participants|||Number
2690546|NCT01316770|Secondary|Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) through Study Day 42|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690533|NCT01316887|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of study drug up to 52 weeks|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug|||Participants|||Number
2690534|NCT01316770|Secondary|Shift Table of Focus Scores From Stage II Screening to Study Day 56|Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Table data are the shift in focus score from Stage II Screening to Study Day 56. Only shift table cells with more than 0 participants were included in the Outcome Measure Data Table below.|Stage II Screening (within 6 wks before baseline) through 56 days post-baseline|Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.|||Participants|||Count of Participants
2690535|NCT01316770|Secondary|Summary Statistics of Focus Score|Focus score is the number of mononuclear cell infiltrates containing at least 50 inflammatory cells in a 4 mm² glandular section. Focus scores ≥1 are key criteria used in the diagnosis of inflammation in the oral component of Sjögren's Syndrome. Higher numbers are associated with more inflammation. (Range 0-12).|Stage II screening (within 6 wks before baseline) through 56 days post-baseline|Secondary Efficacy Population (SEP). Since only the right parotid was biopsied, 9 parotids were biopsied (5 dexamethasone and 4 placebo randomized parotids). At Screening only 4/5 dexamethasone and 4/4 placebo randomized parotids were biopsied. At Study Day 56 only 3/5 dexamethasone and 4/4 placebo randomized parotids were biopsied.|||score on a scale|Parotid gland on right side of mouth|Full Range|Median
2690536|NCT01316770|Secondary|Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit|Change in the evaluations of the parotid technetium scans at Study Day 56 from Stage II Screening Visit. Possible technetium scan evaluations at both Baseline and Study Day 56 include: Normal; Abnormal.|Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690537|NCT01316770|Secondary|Summary Statistics of Technetium Scans|Medical evaluations of Technetium Scans. Possible evaluations include: i) Normal; and ii) Abnormal.|Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690538|NCT01316770|Secondary|Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit|Change in the evaluations of the parotid MRI scans at Study Day 56 from Stage II Screening Visit. Possible MRI evaluations at both Baseline and Study Day 56 include: i)Normal; ii) Abnormal, not clinically significant (Abnormal ncs); and iii) Abnormal, clinically significant (Abnormal cs).|Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690539|NCT01316770|Secondary|Summary Statistics of MRI Scans|Medical evaluations of MRI Scans. Possible evaluations include: i) Normal; ii) Abnormal, not clinically significant; iii) Abnormal, clinically significant.|Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690540|NCT01316770|Secondary|Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) to Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690541|NCT01316770|Secondary|Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) to Study Day 42|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690542|NCT01316770|Secondary|Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) to Study Day 28|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690593|NCT01316575|Secondary|Length of Stay in Hospital||Up to 2 weeks||||days||Standard Deviation|Mean
2690594|NCT01316575|Secondary|Number of Participants Requiring Admission to ICU||Up to 2 weeks||||participants|||Number
2690595|NCT01316575|Secondary|Number of Participants Requiring Reintubation||Up to 2 weeks||||participants|||Number
2690547|NCT01316770|Secondary|Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) through Study Day 28|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690548|NCT01316770|Secondary|Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores|Ordinal Scale 0: least to 10: greatest level of disease activity. Only cells in the shift table with participant counts greater than 0 are listed.|Baseline (Study Day 0) through Study Day 14|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690549|NCT01316770|Secondary|"Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days."|Possible Response: Yes or No|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690550|NCT01316770|Secondary|Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome):|Response: Yes; No|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690551|NCT01316770|Secondary|Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now:|Nominal Scale: Much better; Better; The same; Worse; Much worse|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||Participants|||Count of Participants
2690552|NCT01316770|Secondary|Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores|Ordinal Scale 0: least to 10: greatest level of disease activity.|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||score on a scale||Full Range|Median
2690553|NCT01316770|Secondary|Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?|Response: Yes or No|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||Participants|||Count of Participants
2690554|NCT01316770|Secondary|Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)|Nominal scale values: Inactive; Low; Moderate; High|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||Participants|||Count of Participants
2690555|NCT01316770|Secondary|Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)|Ordinal Scale 0:least to 10:greatest level of disease activity|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||units on a scale||Full Range|Median
2690556|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||Participants|||Count of Participants
2690557|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||Participants|||Count of Participants
2690558|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.|Baseline (Study Day 0) through Study Day 56|"Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0. The shift tables were limited to binary outcomes; participants that answered not sure were excluded from the shift tables."|||Participants|||Count of Participants
2690559|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690560|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690561|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on Study Days 42 and 56.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690562|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56. The shift table data were not sufficiently distributed to permit analysis with McNemar's test on any of the study days.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690563|NCT01316770|Secondary|Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?|Shift table with respect to the change from the Stage II Screening Visit (used as Baseline) for Study Days: 14, 28, 42, and 56|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690564|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690565|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: To little; to much; Do not notice it.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690566|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690567|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes; No; Not sure.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690568|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690569|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690570|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify:|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690676|NCT01316276|Primary|Systolic BP: Change From Baseline at Day 672|Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.|From Study Initiation up to Day 672|Safety Population Patients with missing data were excluded.|||mmHg||Standard Deviation|Mean
2690571|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690572|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690573|NCT01316770|Secondary|Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690574|NCT01316770|Secondary|Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690575|NCT01316770|Secondary|Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690576|NCT01316770|Secondary|Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?|The questionnaire's question is on the whole participant level rather than on the individual parotid level; thus, no treatment group comparisons are possible. Possible responses: Yes or No.|Baseline (Study Day 0) through Study Day 56|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||Participants|||Count of Participants
2690577|NCT01316770|Secondary|Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.|Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 42 and not the flow at any particular time.|Baseline to 42 days post-baseline|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||g/min|Parotid galnd on one side of the mouth|Standard Deviation|Mean
2690578|NCT01316770|Secondary|Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.|Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 28 and not the flow at any particular time.|Baseline to 28 days post-baseline|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||g/min|Parotid gland on one side of the mouth|Standard Error|Mean
2690579|NCT01316770|Secondary|Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.|Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and hel in place by slight negative pressure. Collection time was 1 minute. The outcome measure is looking at change from baseline at Study Day 14 and not the flow at any particular time.|Baseline to 14 days post-baseline|Secondary Efficacy Population (SEP): all enrolled participants who receive at least one on-treatment set of parotid irrigations and have at least one salivary flow assessment after study Day 0.|||g/min|Parotid gland from one side of the mouth|Standard Error|Mean
2690580|NCT01316770|Primary|Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.|Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.|Baseline (Study Day 0) to Study Day 56|Primary Efficacy Population (PEP): all enrolled participants who receive all parotid irrigations on study Days 0 and 28, have the same treatment applied to the same parotid (regardless of random assignment) at both visits, and have values for the primary endpoint (i.e., change in salivary flow from Day 0 to Day 56).|||g/min||Standard Error|Mean
2690677|NCT01316276|Primary|Heart Rate: Change From Baseline From Day 672|Pulse rate (after at least 5-minute rest) was recorded at every visit as per standard practice at each investigational site.|From Study Initiation up to Day 672|Safety Population Patients with missing data were excluded.|||beats/min||Standard Deviation|Mean
2690581|NCT01316692|Other Pre-specified|Correlation Between MLN8237-induced Selective Aurora Kinase A Inhibition in Post-treatment Tumor Sites and Clinical Benefit of MLN8237|In stage 2 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Post-treatment tumor tissue will be assayed for MLN8237-induced selective Aurora Kinase A inhibition and compared to pre-treatment tumor tissue and the results will be compared and contrasted with patients' objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|unable to collected the required number of tumor samples||||||
2690582|NCT01316692|Other Pre-specified|Characterize the de Novo Molecular Mutation Profile of the Melanomas for Association Between Objective Responses to MLN8237 in Patients With Pre-treatment Melanoma Tissue.|In stage 1 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Tissue will be assayed for mutations that are neither parent-possessed, nor able to be transmitted, in pre- and in post-treatment tissue and the results will be compared and contrasted with patients' objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|Collected samples of tumors were very limited. It did not allow us to perform the described assays||||||
2690583|NCT01316692|Secondary|Number of Grade 3 and 4 Study-related Toxicities|Event are graded using National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. toxicities measured on day 1 of each 21-day cycle. Treatment continues to disease progression, toxicity, or withdrawal for other reasons.|at 18 weeks|total numbers of adverse events, patients experiencing grade 3 and 4 related to study treatment|||toxicities|||Number
2690584|NCT01316692|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details) Evaluated every 3 months for 12 months, then every 6 months|On treatment date to last follow-up or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2690585|NCT01316692|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the duration in time from start of therapy to last follow-up, disease progression, or death for any reason.measured every 6 weeks for 24 weeks, and then every 12 weeks or to last date known alive or death, determined every 6 months for up to 5 years. For those who are alive and without progression, they are censored at the last date known alive.|On treatment date to last follow-up, disease progression or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2690586|NCT01316692|Primary|Overall Response Rate|If 2 or more of 23 pts show CR/PR in stage 1, then an additional 33 pts will be enrolled in stage 2. If 6 or more of the total 56 pts show CR/PR at 18 weeks, then further clinical trials will be warranted. Per Response Evaluation Criteria in Solid Tumor (RECIST)1.1: Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|At 18 weeks|All patients with Objective Response, defined as a complete or partial response.|||participants||95% Confidence Interval|Number
2690587|NCT01316614|Secondary|Amount of Blood||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
2690588|NCT01316614|Secondary|Contamination|Percentage of area of slide that represents GI contamination|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
2690589|NCT01316614|Secondary|Adequacy of Specimen||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
2690590|NCT01316614|Secondary|Degree of Cellularity|Number of cells per slide|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
2690591|NCT01316614|Secondary|Degree of Cellularity|Percentage of area of slide that contains cells of the representative lesion|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
2690592|NCT01316614|Primary|Compare Adequacy of Diagnoses in Passes With and Without a Stylet|"The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet.~There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes."|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 overall passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
2690596|NCT01316575|Primary|Alveolar - Arterial Gradient|The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen|1 hour following admission to PACU|From the literature, a sample size of 19 subjects per group is required for a power >0.9 and alpha <0.05 assuming a normalised difference in A-a gradient between groups of 0.33 and a Standard Deviation (SD) of 0.33|||torr||Standard Deviation|Mean
2690597|NCT01316510|Secondary|Length of Hospital Stay|Number of days from surgery until discharge|Initial discharge from the hospital||||days||Standard Deviation|Mean
2690598|NCT01316510|Primary|Composition of the Fecal Microbiota|"Stools will be collected from messy diapers.~Percentage bifidobacteria = total bifidobacteria per Group divided by the total bacteria per Group multiplied by 100% Percentage clostridia = total clostridia per Group divided by the total bacteria per Group multiplied by 100%"|Final stool sample at 6 weeks|Final stool sample|||percentage of total bacteria|||Number
2690599|NCT01316419|Secondary|Incidence and Severity of Reported Adverse Events.|Incidence as per the severity of reported adverse events is presented.|24±2 weeks|Patients having received at least one dose of Twynsta tablets|||participants|||Number
2690600|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.|||percentage of participants|||Number
2690601|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|12±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.|||percentage of participants|||Number
2690602|NCT01316419|Secondary|Percentage of Patients Achieving Normal Body Mass Index (BMI)|Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.|||percentage of participants|||Number
2690603|NCT01316419|Secondary|Mean Blood Lipid Change - Total Cholesterol|Mean blood lipid change - Total Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
2690604|NCT01316419|Secondary|Mean Blood Lipid Change - Triglyceride|Mean blood lipid change - Triglyceride|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
2690605|NCT01316419|Secondary|Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol|Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
2690606|NCT01316419|Secondary|Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol|Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
2690607|NCT01316419|Secondary|Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease|Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease|24±2 weeks|All patients with diabetes, kidney disease or both (diabetes + kidney disease)|||percentage of participants|||Number
2690608|NCT01316419|Secondary|EuroQol (EQ) Visual Analogue Scale (VAS)|The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'best imaginable health state' and 'worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health.|baseline and 24±2 weeks|Patients with a baseline and an endpoint EQ VAS response|||scores on a scale||Standard Deviation|Mean
2690609|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
2690610|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
2690624|NCT01316380|Secondary|Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment|For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5).|12 weeks|All patients from FAS.|||Number of patients|||Number
2690611|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
2690612|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||scores on a scale||Standard Deviation|Mean
2690613|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
2690614|NCT01316419|Secondary|Percentage of Patients Achieving SBP Response|Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||percentage of participants|||Number
2690615|NCT01316419|Primary|Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||mmHg||Standard Deviation|Mean
2690616|NCT01316419|Secondary|Percentage of Patients Achieving DBP Response|Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||percentage of participants|||Number
2690617|NCT01316419|Secondary|Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.|Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||percentage of participants|||Number
2690618|NCT01316419|Primary|Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||mmHg||Standard Deviation|Mean
2690619|NCT01316380|Secondary|Use of Rescue Medication During Nighttime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.|||puffs of rescue medication||Standard Error|Mean
2690620|NCT01316380|Secondary|Use of Rescue Medication During Daytime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.|||puffs of rescue medication||Standard Error|Mean
2690621|NCT01316380|Secondary|Use of Rescue Medication During 24h Period|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.|||puffs of rescue medication||Standard Error|Mean
2690622|NCT01316380|Secondary|Time to First Asthma Exacerbation During the 12-week Treatment.|An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms.|12 weeks|All patients from FAS.|||Days||Inter-Quartile Range|Median
2690623|NCT01316380|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment.|Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.|12 weeks|All patients from FAS.|||Days||Inter-Quartile Range|Median
2694958|NCT01283282|Secondary|Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels.|Week 12||||µM||Standard Error|Mean
2690625|NCT01316380|Secondary|FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
2690626|NCT01316380|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
2690627|NCT01316380|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
2690628|NCT01316380|Secondary|Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
2690629|NCT01316380|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who received at least one dose of randomized trial medication.|||Liter||Standard Error|Least Squares Mean
2690630|NCT01316341|Primary|Fasting Plasma Glucose (FPG) Change From Baseline|Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.|||mg/dL||Standard Deviation|Mean
2690631|NCT01316341|Primary|Urinary Glucose Excretion (UGE) Change From Baseline|Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.|||mg||Standard Deviation|Mean
2690632|NCT01316341|Secondary|Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference|"Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference.~Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint."|Drug administration until end of trial, up to 21 days|Treated set (TS) includes all patients who were documented to have taken at least one dose of investigational treatment.|||participants|||Number
2690633|NCT01316341|Primary|Predose Plasma Concentration Before Planned Dose x (Cpre,x)|"Predose plasma concentration of empagliflozin (empa) before planned dose by day.~This endpoint in steady state is identical to Cmin,ss."|5 minutes before drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2690634|NCT01316341|Primary|Accumulation Ratio Based on Cmax (R A,Cmax)|Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2690635|NCT01316341|Primary|Accumulation Ratio Based on AUC (R A,AUC)|Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2690636|NCT01316341|Primary|Renal Clearance at Steady State (CL R,ss)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2690637|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)|Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
2690638|NCT01316341|Primary|Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)|Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol||Geometric Coefficient of Variation|Geometric Mean
2690639|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)|Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||L||Geometric Coefficient of Variation|Geometric Mean
2690640|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)|Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2690641|NCT01316341|Primary|Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2690642|NCT01316341|Primary|Terminal Half-life in Plasma at Steady State (t1/2,ss)|Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2690643|NCT01316341|Primary|Terminal Rate Constant in Plasma at Steady State (λz,ss)|Terminal rate constant in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2690644|NCT01316341|Primary|Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2690645|NCT01316341|Primary|Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)|Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2690646|NCT01316341|Primary|Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)|Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2690647|NCT01316341|Primary|Renal Clearance After Extravascular Administration (CL R,0-48)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2700364|NCT01243320|Secondary|Change Systolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmhg||95% Confidence Interval|Mean
2690648|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).|Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
2690649|NCT01316341|Primary|Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)|Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol||Geometric Coefficient of Variation|Geometric Mean
2690650|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)|Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||L||Geometric Coefficient of Variation|Geometric Mean
2690651|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)|Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2690652|NCT01316341|Primary|Mean Residence Time (MRTpo)|Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2690653|NCT01316341|Primary|Terminal Half-life (t1/2)|Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2690654|NCT01316341|Primary|Terminal Rate Constant (λz)|Terminal Rate Constant in Plasma (λz), after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2690655|NCT01316341|Primary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2690656|NCT01316341|Primary|Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2690657|NCT01316341|Primary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2690658|NCT01316341|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2690659|NCT01316315|Other Pre-specified|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing||7 Days|Any patient that received a dose of N6022 or Placebo|||mg/mL||Standard Error|Mean
2690660|NCT01316315|Secondary|To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.|Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed.|10 Weeks|Any patient that received a dose of N6022 or placebo|||Adverse Events|||Number
2690661|NCT01316315|Secondary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|8 hours|Any patient that received a dose of N6022 or Placebo|||mg/mL||Standard Error|Mean
2690662|NCT01316315|Primary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|24 hours|Any patient that received a dose of N6022 or placebo.|||mg/mL||Standard Error|Mean
2690663|NCT01316302|Secondary|Patient Global Impression of Change|Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.|Baseline to study endpoint (Week 12)||||percentage of self-rated responders|||Number
2690664|NCT01316302|Secondary|Clinical Global Impression of Improvement Scale (CGI-I)|CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.|Baseline to Week 12||||% of subjects who were CGI-I responders|||Number
2690665|NCT01316302|Primary|Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score|Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.|Baseline to study endpoint (Week 12)|The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).|||Scores on a scale||Standard Deviation|Mean
2690666|NCT01316276|Secondary|Number of Participants Who Received Antipseudomonal Antibiotic Treatment for Protocol Defined Pulmonary Exacerbation||From Study Initiation up to Day 700|mITT Population|||Participants|||Count of Participants
2690667|NCT01316276|Secondary|Number of Subjects Initiating Treatment.|"The number of subjects initiating antipseudomonal therapy for protocol-defined pulmonary exacerbation confirmed by the investigator, and for investigator-defined pulmonary exacerbation were summarized.~The data presented below is the Frequency of Systemic or Inhaled Antipseudomonal Therapy for Protocol-defined Pulmonary Exacerbations Confirmed by Investigator~- Time to First Use of Any New Antibiotic Treatment, Censoring at Date of Last Contact"|From Study Initiation up to Day 672|mITT|||Participants|||Count of Participants
2690668|NCT01316276|Secondary|Number of Subjects Experiencing a Protocol Defined Pulmonary Exacerbation|For number of subjects to first protocol-defined pulmonary exacerbation, follow-up time began at the first dose of study drug (Day 1) and ended no later than Day 700 (28-day follow up).|From Study Initiation up to Day 700|mITT|||participants|||Number
2690669|NCT01316276|Secondary|Percent Change in FEV1 Throughout the Study|Percent Change From Baseline in Predose FEV1|Baseline, Day 337 and Day 672|modified intention to treat (mITT) population|||Percent (%) change||Standard Deviation|Mean
2690670|NCT01316276|Primary|Change in Serum Creatinine Throughout the Study|"Common Terminology Criteria for Adverse Events (CTCAE) Grade 1: > ULN-1.5 × ULN~CTCAE Grade 2: > 1.5 × ULN to 3.0 x ULN"|Baseline, Day 337 and Day 672|Safety Population|||Participants|||Count of Participants
2690671|NCT01316276|Primary|Evaluation of Audiology|Hearing was evaluated using air conduction [AC]. Bone conduction was required if the AC testing demonstrated a decrease of >20 decibels [dB]. Hearing loss was categorized using Common Terminology Criteria for Adverse Events as follows: GRADE 1 (best): Adults [A] on a Monitoring Program [MP]: Threshold shift of 15-25 dB; Pediatric [P]: Threshold shift >20 dB at 8 kilohertz (kHz). GRADE 2: [A] on a MP: Threshold shift of >25 dB; [A] not enrolled in MP: hearing loss; hearing aid/intervention not indicated; [P]: Threshold shift >20 dB at 4 kHz and above. GRADE 3: [A] enrolled in MP: Threshold shift of >25 dB; therapeutic intervention indicated; [A]: Not enrolled in MP: hearing aid/intervention; [P]: therapeutic intervention, including hearing aids: Threshold shift >20 dB at 3 kHz and above; additional speech-language related services. GRADE 4 (worst): [A]: Profound bilateral hearing loss; non-serviceable hearing; [P]: cochlear implant & additional speech-language related services.|Day 337 and Day 672|Safety Population|||Participants|||Count of Participants
2690672|NCT01316276|Primary|Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672|"Sputum was cultured for quantitative microbiological evaluation of Pa and Burkholderia species in designated regional central microbiology laboratories. A standard microbiology protocol was used for Pa culture and identification for each morphologically distinct Pa phenotype.~Although planned in the Statistical Analysis Plan (SAP), MICs of amikacin Burkholderia species were not determined due to the small number of isolates with Burkholderia. In addition, susceptibility testing of isolates of Pa and Burkholderia species against a panel of commonly used antipseudomonal antibiotics was planned but was not performed.~The results of the following analyses for Pa isolates are presented.~Frequency of MIC of Amikacin~Frequency of MIC of Tobramycin~MIC50: lowest concentration of the antibiotic at which 50 % of the isolates were inhibited."|Day 1, Day 169, Day 337, Day 505 and Day 672|"Safety Population~Patients with missing data were excluded."|||µg/mL||Full Range|Median
2690673|NCT01316276|Primary|Oxygen Saturation: Change From Baseline at Day 672|Change in oxygen saturation as measured with pulse oximetry was performed via finger probes placed on the extremity opposite arterial lines and noninvasive blood pressure monitoring devices so that pulsatile flow was not interrupted.|From Study Initiation up to Day 672|Safety Population Patients with missing data were excluded.|||Percent of Hemoglobin||Standard Deviation|Mean
2690674|NCT01316276|Primary|Body Temperature: Change From Baseline at Day 672|Body temperature was recorded at every visit as per standard practice at each investigational site.|From Study Initiation up to Day 672|Safety Population Patients with missing data were excluded.|||Degrees Celcius||Standard Deviation|Mean
2690675|NCT01316276|Primary|Diastolic BP: Change From Baseline at Day 672|Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.|From Study Initiation up to Day 672|Safety Population Patients with missing data were excluded.|||mmHg||Standard Deviation|Mean
2690678|NCT01316276|Primary|Respiratory Rate: Change From Baseline to Day 672|Respiratory rate was recorded at every visit as per standard practice at each investigational site.|From Study Initiation up to Day 672|Safety Population Patients with missing data were excluded.|||breaths per minute||Standard Deviation|Mean
2690679|NCT01316276|Primary|Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose|Number of Subjects with a >15% in Decline in Forced Expiratory Volume in 1 Second (FEV1) From Predose to Postdose|Day 1, Day 84, Day 196, Day 281, Day 337, Day 449, Day 532 and Day 644|"Safety Population~Patients with missing values were excluded."|||Participants|||Count of Participants
2690680|NCT01316276|Primary|Laboratory Abnormalities up to Day 672|"Number of Subjects with Grade 3 or Higher Abnormalities in Clinical Laboratory Values~Number of Subjects with Grade 3 or Higher Hematology Laboratory Value Abnormalities~Number of Subjects with Grade 3 or Higher Chemistry Laboratory Value Abnormalities"|Baseline, Day 377 and Day 672|Safety Population|||Participants|||Count of Participants
2690681|NCT01316276|Primary|Treatment Emergent Adverse Events (TEAEs) up to Day 672|Treatment emergent adverse events including serious adverse events (SAE) and adverse events (AE) leading to permanent discontinuation of study drug|From Study Initiation up to Day 672|Safety Population|||Participants|||Count of Participants
2690682|NCT01316263|Secondary|Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results|Participants with Treatment Emergent (TE) anti-olaratumab (IMC-3G3) antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.|||percentage of participants|||Number
2690683|NCT01316263|Secondary|Volume of Distribution at Steady State (Vss)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
2690684|NCT01316263|Secondary|Clearance (CL)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
2690685|NCT01316263|Secondary|Half Life (t½)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
2690686|NCT01316263|Secondary|Area Under the Curve (AUC)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
2690687|NCT01316263|Secondary|Maximum Concentration (Cmax)||Day 1 of Cycles 1 and 3 (14-day cycles)|All participants who had evaluable pharmacokinetic (PK) Cmax results at the specific time point. Due to the limited data, Cmax is not representative of the study population.|||nanograms per milliliter (ng/mL)||Full Range|Mean
2690688|NCT01316263|Secondary|Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]|DCR defined as CR, PR or SD using RECIST v1.1 criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify PD, taking as reference the smallest sum diameter since the treatment started. PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. Percentage of participants=(number of participants with CR+PR+SD/number of participants in group) * 100.|Baseline up to 35.9 weeks|All participants who received any study drug.|||percentage of participants||90% Confidence Interval|Number
2690689|NCT01316263|Secondary|Number of Participants With Adverse Events (AE) and Participants Who Died|Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. The number of participants who died due to an AE or disease progression are also reported.|Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up|All participants who received any study drug.|||participants|||Number
2690690|NCT01316263|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose of study drug to the date of death from any cause. Participants who were alive at the end of the post-study follow-up or were lost to follow-up were censored on the last date the participant was known to be alive.|Date of first dose of study drug to the date of death from any cause up to 57.3 weeks|All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4.|||weeks||90% Confidence Interval|Median
2690691|NCT01316263|Secondary|Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]|The ORR was the best overall response of CR and PR using RECIST, v1.1 criteria. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator that calculated the response rate. Percentage of participants = (number of participants achieving a response/total of participants treated) * 100.|Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up|All participants who received any study drug.|||percentage of participants||90% Confidence Interval|Number
2690702|NCT01316224|Secondary|Mean Change in Quality of Life (QoL)|The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|ITT population|||Score on scale||Standard Deviation|Mean
2690703|NCT01316224|Secondary|Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA|Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.|||Percentage of participants|||Number
2690692|NCT01316263|Secondary|Progression-Free Survival (PFS)|PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.|Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks|All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0.|||weeks||90% Confidence Interval|Median
2690693|NCT01316263|Primary|Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks|Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) *100.|12 weeks|All participants who received any study drug.|||percentage of participants||90% Confidence Interval|Number
2690694|NCT01316224|Secondary|Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%|This outcome measure was not calculated.|At Baseline, Week 24, and Week 48|||||||
2690695|NCT01316224|Secondary|Incidence Rate of PsA Since Psoriasis Diagnosis|"The number of new PsA cases were determined by:~PsA defined by a rheumatologist; or~A participant with inflamed joints >0 and CASPAR score >=3; or~Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA)."|Baseline up to Visit 4 (month 12)|ITT population|||new PsA cases per 100 person years||95% Confidence Interval|Number
2690696|NCT01316224|Primary|Percentage of Participants Who Developed Signs or Symptoms of PsA|Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
2690697|NCT01316224|Primary|Percentage of Participants Who Developed Psoriatic Arthritis (PsA)|"A participant is said to have PsA if they meet the following criteria:~PsA defined by a rheumatologist; or~A participant with inflamed joints >0 and CASPAR score >=3; or~Participant meeting at least one of the two previous definitions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
2690698|NCT01316224|Secondary|Percentage of Participants With Joint Symptoms|Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
2690699|NCT01316224|Secondary|Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero|"Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
2690700|NCT01316224|Secondary|Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point).|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
2690701|NCT01316224|Secondary|Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||CASPAR score||Standard Deviation|Mean
2690704|NCT01316224|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).|At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)|ITT population|||PASI score||Standard Deviation|Mean
2690705|NCT01316224|Secondary|Mean Time to First Occurrence of PsA Signs or Symptoms|The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.|||Years||95% Confidence Interval|Mean
2690706|NCT01316055|Secondary|The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT|||liter/hour||90% Confidence Interval|Geometric Mean
2690707|NCT01316055|Secondary|The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT|||nanogram/milliliter||90% Confidence Interval|Geometric Mean
2690708|NCT01316055|Primary|The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).|AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.|0 and 1,2,3,4,5,6,8, and 12 hours after the last dose|Intention to treat (ITT)|||hour*nanogram/milliliter||90% Confidence Interval|Geometric Mean
2690709|NCT01316042|Primary|Change in Serum DHEAS Levels|Change in DHEAS level was constructed per subject as the 1-year measurement minus the baseline measurement. Only descriptive statistics are provided, statistical tests were not conducted given the extremely small sample size per group.|1 year||||ug/dL||Full Range|Mean
2690710|NCT01315873|Secondary|Duration of Response of This Regimen.|Time from response to relapse. Response would have been assessed using European Group for Blood and Marrow Transplantation (EBMT) criteria modified to include near complete remission (nCR) and very good partial remission (VGPR|from initial response to relapse, up to 100 weeks.|Participant data was not analyzed because PI left institution||||||
2690711|NCT01315873|Secondary|Toxicity of This Regimen.|Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.|Every 4 weeks.|Participant data was not analyzed because PI left institution. Data were not available for analysis.||||||
2690712|NCT01315873|Primary|Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine|These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)|8 weeks|Participant data was not analyzed because PI left institution||||||
2690713|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During Period When Migraine is Absent (Interictal Phase)(Part III, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 2 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO||||||
2690714|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During a Migraine Attack (Ictal Phase)(Part III, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 1 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO||||||
2690715|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|In Part I, Period 2 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 1, 2, 3 and 4 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part 1, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol|||μM||Standard Deviation|Mean
2690716|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 miniutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol|||percent CGRP RO|||Number
2690717|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|In Part I, Period 1 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 2, 3, 4 and 5 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol|||μM||Standard Deviation|Mean
2690718|NCT01315847|Primary|Brain Calcitonin Gene-related Peptide (CGRP) Receptor Occupancy (RO) Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, regions of interest (ROIs) were drawn throughout cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue time-activity curves (TACs). Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. Total volume of distribution (VT), an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. Change in VT between baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol|||percent CGRP RO|||Number
2690719|NCT01315847|Primary|Number of Participants With AEs (Part III)|Any AEs occurring among participants (all were migraine patients) in Part III of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part III of study (Up to approximately 6 months)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part III of study.|||participants|||Number
2690720|NCT01315847|Primary|Number of Participants With Adverse Events (AEs) (Part I)|Any AEs occurring among participants (all were healthy subjects) in Part I of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part I of study (Up to approximately 14 weeks)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part I of study.|||participants|||Number
2690721|NCT01315678|Secondary|Relative Percent (%) Change in Respiratory Symptoms as Measured by the CFQ-R|Quality of Life was measured by the absolute change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory scale. Disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms in patients with a diagnosis of cystic fibrosis. Scores range from 0 to 100, with higher scores indicating better health. Scores for each Health Related Quality of Life (HRQoL) domain; after recoding, each item is summed to generate a domain score and standardized.|Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168|Modified intent-to-treat (mITT; received at least 1 dose of study drug)|||Percent (%) change||Standard Error|Least Squares Mean
2690722|NCT01315678|Secondary|Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum|Change in density (Log CFU) from baseline in Pseudomonas aeruginosa in sputum|Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168|Modified intent-to-treat (mITT; received at least 1 dose of study drug)|||Log 10 CFU||Standard Deviation|Mean
2690723|NCT01315678|Secondary|Number of Subjects to First All Cause Hospitalization|Number of Subjects to first all cause hospitalization measured by number with event and number censored|168 days|Modified intent-to-treat (mITT; received at least 1 dose of study drug)|||participants|||Number
2690724|NCT01315678|Secondary|Number of Subjects to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation|Number of Subjects to first antipseudomonal antibiotic treatment for pulmonary exacerbation measured by number with event and number censored|168 days|Modified intent-to-treat (mITT; received at least 1 dose of study drug)|||Participants|||Count of Participants
2690725|NCT01315678|Secondary|Number of Subjects Experiencing a Pulmonary Exacerbation|Number of Subjects experiencing a pulmonary exacerbation measured by number with event and number censored|168 days|Modified intent-to-treat (mITT; received at least 1 dose of study drug)|||participants|||Number
2690726|NCT01315678|Secondary|Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)|Relative changes (%) from baseline to Study Days 14, 28, 57, 84, 113, 140, 168 in FEV1|Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168.|Modified intent-to-treat (mITT; received at least 1 dose of study drug)|||percentage (%) change||Standard Deviation|Mean
2690727|NCT01315678|Primary|Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)|Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)|Baseline to168 days|The PP is the primary analysis population for the primary efficacy analysis|||Percent (%) change||Standard Deviation|Mean
2690728|NCT01315665|Secondary|Measure of Neutrophil Migration Into the Gingival Crevices|Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.|Baseline and end of 5 day treatment period||||Neutrophils/mL (Log10)||Standard Deviation|Mean
2690729|NCT01315665|Secondary|Measures of Oxidative Stress in Urine|Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period||||ng/mg creatinine (Log10)||Standard Deviation|Mean
2690730|NCT01315665|Secondary|Measures of Glutathione From Blood Lymphocytes|Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period|Not enough blood could be obtained from one of the healthy volunteers. Therefore, glutathione from blood lymphocytes could not be evaluated from that healthy volunteer. With respect to this outcome measure, only results from 9 healthy volunteers are reported.|||Micro Molar||Standard Deviation|Mean
2690731|NCT01315665|Secondary|Measures of Lipid Peroxidation in Nasal Epithelial Cells|Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)|End of 5 day treatment period|Data not collected and will not be analyzed.||||||
2690732|NCT01315665|Primary|Nrf2 Activation in Nasal Epithelial Cells|Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)|Baseline and of end of 5 day treatment period||||participants|||Number
2690733|NCT01315574|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.|||Seconds||Standard Deviation|Mean
2690734|NCT01315574|Secondary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.|||units on a scale (1-4)||Standard Deviation|Mean
2690735|NCT01315574|Primary|Effectiveness in Lowering Intraocular Pressure|Applanation tonometry will be used to measure patients' intraocular pressure|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.|||mmHg||Standard Deviation|Mean
2690736|NCT01315353|Secondary|Percentage of Participants With Targeted AEs Reported Post LEEP.|LEEP was performed on participants who had CIN2+. For Arm A participants, LEEP was available starting at week 26; for Arms B and C, LEEP was available starting at study entry. Targeted AEs four weeks after LEEP is provided in the data table below. The AE categories are not mutually exclusive. A participant may have experienced AEs and may be counted in more than one category.|4 weeks post LEEP|Participants in each arm who had LEEP were included in the analysis.|||percentage of participants|||Number
2690737|NCT01315353|Secondary|Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A.|Cryotherapy was performed in Arm A within 7 days of study entry. Targeted AEs four weeks after cryotherapy is provided in the data table below. The AE categories are not mutually exclusive. A participant may have experienced AEs and may be counted in more than one category.|4 weeks post cryotherapy|Included Arm A participants who had cryotherapy.|||percentage of participants|||Number
2690738|NCT01315353|Secondary|Number of Participants With High Risk (hr)-HPV by the Roche Linear Array HPV Genotyping Test at Study Visits.|Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Roche Linear Array HPV Genotyping test. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.|Weeks 26, 52, 78, 104 and 130 post randomization|Includes participants with results for the Roche Linear Array HPV Genotyping test.|||Participants|||Count of Participants
2690739|NCT01315353|Secondary|Number of Participants With High Risk (hr)-HPV by the Xpert HPV Assay at Study Visits.|Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Xpert HPV assay. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.|Weeks 26, 52, 78, 104 and 130 post randomization|Includes participants with results for Xpert HPV assay|||Participants|||Count of Participants
2690740|NCT01315353|Secondary|Number of Participants With High Risk (hr)-HPV by the Abbott Real Time High-risk HPV Assay (aHPV) at Study Visits.|Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Abbott Real Time high-risk HPV assay. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.|Weeks 26, 52, 78, 104 and 130 post randomization|Includes participants with results for Abbott Real Time high-risk HPV assay|||Participants|||Count of Participants
2690761|NCT01315236|Secondary|Ordinal, 3-level Response From Baseline on the SQS for Mycobacterial Culture for the LAI Arm at Day 84 Compared to the Placebo Arm at Day 84|The ordinal, 3-level response are (1) improvement (2) no change (3) worsening or death|Baseline and end of double-blind phase of 84 days|mITT|||Participants|||Count of Participants
2690741|NCT01315353|Secondary|Number of Participants With Abnormal Cytology Results at Study Visits.|Number of participants with abnormal (ASCUS: atypical squamous cells; undetermined significance, ASC-H: atypical squamous cells; favor high-grade squamous intra-epithelial lesion, LSIL: low-grade squamous intraepithelial lesion/mild dysplasia/HPV, HSIL: high-grade squamous intraepithelial lesion/moderate or severe dysplasia/carcinoma in situ/features of invasion; squamous cell carcinoma) cytology results.|Weeks 26, 52, 78, 104 and 130 post randomization|Included participants with available cytology results.|||Participants|||Count of Participants
2690742|NCT01315353|Secondary|Number of Participants Who Discontinued Study Early.|The number of participants who did not complete the study.|0 to 130 weeks post randomization|Intent to treat: All eligible participants were included in the analysis. Analysis was limited to the two randomized study arms (Arms A and B).|||Participants|||Count of Participants
2690743|NCT01315353|Secondary|Cumulative Rate of CIN3+ (CIN3 or Invasive Cancer) by Week 130.|"The Kaplan-Meier estimate of the cumulative rate of CIN3+ (CIN3 or invasive cancer) by week 130.~Time to CIN3+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN3+ was first detected. For those who did not develop CIN3+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN3+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory."|Weeks 26, 52, 78, 104 and 130 post randomization|Intent-to-treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Analysis was limited to the two randomized study arms (Arms A and B).|||Cumulative rate of events/100 persons||95% Confidence Interval|Number
2690744|NCT01315353|Secondary|Time to CIN2+ Diagnosis by Biopsy, as Determined by Local Review at a DAIDS-assessed Laboratory.|Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. The 10th percentile of the time to CIN2+ (the number of weeks at which 10% of participants had had CIN2+ diagnosis) is presented in the data table below.|Weeks 26, 52, 78, 104 and 130 post randomization|Intent to treat: All eligible participants were included in the analysis. Analysis was limited to the two randomized study arms (Arms A and B).|||weeks||95% Confidence Interval|Number
2690745|NCT01315353|Primary|Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130|"The Kaplan-Meier estimate of the cumulative rate of CIN2+ (CIN2, CIN3 or invasive cancer) by week 130.~Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN2+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory."|Weeks 26, 52, 78, 104 and 130 post randomization|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Analysis was limited to the two randomized study arms (Arms A and B).|||Events per 100 persons||95% Confidence Interval|Number
2690746|NCT01315249|Secondary|Number of Participants With Adverse Events|The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.|26 weeks|Safety set includes all participants who received at least one dose of study drug.|||participants|||Number
2690747|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (26 Weeks)|After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|26 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.~flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."|||Liters||Standard Error|Least Squares Mean
2690748|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (12 Weeks)|After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|12 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.~flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."|||Liters||Standard Error|Least Squares Mean
2690749|NCT01315249|Secondary|Change From Baseline in Symptom Scores Reported Using the Ediary|"Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.~Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.~0 is the minimum score = none or No symptoms or never or No~= mild, a little~= moderate~= severe For the scale range provided, high values represent a worse outcome."|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||units on a scale||Standard Error|Least Squares Mean
2690750|NCT01315249|Secondary|Mean Change From Baseline in Daily Number of Puffs of Rescue Medication|Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.|Baseline, 12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||puffs||Standard Error|Least Squares Mean
2690762|NCT01315236|Secondary|Time to Negative NTM Culture….During the 84-day Double-blind Treatment Phase|Sputum specimens were cultured in liquid media in addition to solid media (agar). If results were negative on agar, the liquid media was held for 6 weeks before reporting as culture negative. Culture was negative when confirmed with no growth in liquid medium.|84 days double-blind phase|mITT|||days||Inter-Quartile Range|Median
2690751|NCT01315249|Secondary|Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)|The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||units on a scale||Standard Error|Least Squares Mean
2690752|NCT01315249|Secondary|Focal Score of the Transitional Dyspnea Index (TDI)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||units on a scale||Standard Error|Least Squares Mean
2690753|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 26)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2690754|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 12)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2690755|NCT01315249|Secondary|Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours|Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2690756|NCT01315249|Primary|Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.|Week 26|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2690757|NCT01315236|Secondary|"Number of Subject for Rescue Anti-mycobacterial or Other Rescue Drugs During the 84-day Double-blind Phase"|"Per the study protocol, study subjects were on a stable, multi-drug, anti-mycobacterial regimen based on the 2007 ATS/IDSA Guidelines; the regimen should not have changed during the study period except for safety concerns. The need for changes to the concurrent anti-mycobacterial regimen or rescue therapy was at the discretion of the Investigator and was tracked as a study outcome."|84 days double-blind phase|mITT|||participants|||Number
2690758|NCT01315236|Secondary|"Number of Participants Requiring Rescue Anti-mycobacterial or Other Rescue Drugs During the 84-day Double-blind Phase"|"Per the study protocol, study subjects were on a stable, multi-drug, anti-mycobacterial regimen based on the 2007 ATS/IDSA Guidelines; the regimen should not have changed during the study period except for safety concerns. The need for changes to the concurrent anti-mycobacterial regimen or rescue therapy was at the discretion of the Investigator and was tracked as a study outcome."|84 days double-blind phase|mITT|||participants|||Number
2690759|NCT01315236|Secondary|Change From Baseline in Global Rating of Health (GRH) at Day 84 for the LAI Arm Compared to the Placebo Arm|"The assessing physician asked the subject to rate his/her assessment of health according to the GRH. Subject responses to, How would you rate your health at the present time? included: Excellent, Good, Fair, or Poor."|Baseline and end of double-blind phase of 84 days|"mITT~Subjects with missing data were excluded"|||Participants|||Count of Participants
2690760|NCT01315236|Secondary|Change From Baseline in Respiratory and Systemic Symptoms Questionnaire (RSSQ) Score at Day 84 for the LAI Arm Compared to the Placebo Arm|The RSSQ was administered to gather information from the subject about the types of symptoms that the subject has experienced since the last contact. A reduction in score indicates improvement. The range of values for the scores are -2 (best) to +2 (worst) in whole numbers. The composite score was calculated by averaging the scores of the subscales.|Baseline to day 84.|mITT|||units on a score||Standard Deviation|Mean
2691609|NCT01308918|Secondary|Number of Complications Associated to the GlideRite DLT Stylet® Utilization|Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.|1 hour (Post intubation)||||Participants|||Number
2690763|NCT01315236|Secondary|Number of Subjects With Negative NTM Culture for the LAI Arm at Day 84 Compared to the Placebo Arm at Day 84|Sputum specimens were cultured in liquid media in addition to solid media (agar). If results were negative on agar, the liquid media was held for 6 weeks before reporting as culture negative. Culture was negative when confirmed with no growth in liquid medium.|84 days double-blind phase|mITT|||Participants|||Count of Participants
2690764|NCT01315236|Primary|Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84.|The endpoint used the 7-step semi-quantitative scale (SQS) for mycobacterial culture reporting in both solid and liquid growth media, with step 1 = culture negative in both solid and liquid media, step 2 = growth in liquid medium only, 3 = solid medium positive, 4 = 50 to 100 colonies in solid medium & growth in liquid, 5 = >100 to 200 colonies in solid medium & growth in liquid, 6 = >200 to 500 colonies in solid medium & growth in liquid, 7 = >500 colonies in solid medium & growth in liquid. Full scale range is 1 (best score) to 7 (worst score). The change in step measures the growth at Day 84 compared to the growth at Baseline. The negative values represent reduction in colony growth.|Baseline and end of double-blind phase of 84 days|mITT|||Participants|||Count of Participants
2690765|NCT01315158|Secondary|Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups|The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.|24-48 hours||||participants|||Number
2690766|NCT01315158|Secondary|Patient Tolerance as Assessed by Endoscopists|The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.|24-48 hours|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.||||||
2690767|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication||One year||||incidences|||Number
2690768|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)||One year||||incidences|||Number
2690769|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)||One year||||incidences|||Number
2690770|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)||One year||||participants|||Number
2690771|NCT01315158|Secondary|Compare Propofol Doses Between the Two Groups|The dose of propofol used between the two groups will be compared|One day (during procedure)|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.||||||
2690772|NCT01315158|Secondary|Number of Participants Who Experience Other Sedation Related Complications|Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups|One day (during procedure)||||participants|||Number
2690773|NCT01315158|Primary|Number of Participants Who Experience Airway Maneuvers|In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.|One day (during procedure)||||participants|||Number
2690774|NCT01315145|Primary|Percentage of Participants With a 2-point Improvement in Visual Analogue Scale|The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.|16 weeks|All participants who reported 16 week outcomes are included in this analysis.|||percentage of responders|||Number
2690775|NCT01315132|Secondary|Graft Versus Host Disease (GVHD)||1 Year after transplant||||Participants|||Count of Participants
2690776|NCT01315132|Primary|Number of Patients With Overall Survival|The primary objective of this prospective, phase II trial was to obtain an OS rate of >60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The >60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.|1 Year after transplant||||Participants|||Count of Participants
2690777|NCT01315028|Secondary|Global Assessment of Functioning (GAF)|Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.|monthly until October 2011||||units on a scale||Standard Deviation|Mean
2690778|NCT01315028|Secondary|The Internal State Scale (ISS) (Bauer et al, 1991)|"The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200).~The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows:~Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania >155 >125 Mixed State >155 <125 Euthymia <155 >125 Depression <155"|monthly until October 2011||||units on a scale||Standard Deviation|Mean
2690779|NCT01315028|Primary|Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]|"The Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are:~0 to 15 - normal /symptom absent 15 to 20 - mild 21 to 28 - moderate >34 - severe"|Baseline to End of Study||||units on a scale||Standard Deviation|Mean
2690780|NCT01315028|Primary|Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)|"The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are:~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|Baseline to End of Study.||||units on a scale||Standard Deviation|Mean
2690781|NCT01315002|Primary|Error Percentage in Antisaccade Task|Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.|Three hours after patch application||||Error Percentage in Antisaccade Task||Standard Deviation|Mean
2690782|NCT01314963|Primary|Relative Node Detection Sensitivity|Relative node detection sensitivity (S) was defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N). The outcome result is expressed as the percentage for each device with 95% confidence intervals.|1 day|Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods.|||Percentage (%) of SLNs detected|Sentinel lymph nodes (SLNs)|95% Confidence Interval|Number
2690783|NCT01314911|Secondary|Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples|This AUC was calculated using the trapezoidal rule and the units of measurement are (days*log10 copies/mL) with the fact that it was the level of virus above the LLOQ being considered. The calculation of AUC was undertaken using measurements from Day 0 to Day 3 which were collected under all versions of the protocol (i.e. evening measurements on Days 0, 1 and 2 were not used as these were collected for only about 20% of subjects). Missing values during follow-up were ignored. This is equivalent to imputing a missing value using linear interpolation between the preceding and succeeding available values. For the five subjects with missing values following a last available measurement which was above the LLOQ, the remaining values were assumed to be the mean of preceding value and LLOQ in calculating the AUC.|From Day 0 to Day 3|The population analyzed is the Primary Efficacy Population (PEP). The two subjects with missing values at Day 0 (one in each randomized arm) were excluded from this analysis.|||days*log10 copies/mL||Inter-Quartile Range|Median
2690784|NCT01314911|Secondary|qPCR Viral Shedding -- Self Collected Samples|Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.). Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.|At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||log10 copies/mL||Inter-Quartile Range|Median
2690785|NCT01314911|Secondary|Number of Participants by Virus Detection Status --Self Collected Samples|Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ. Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.|At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
2690786|NCT01314911|Secondary|Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples|For participants with a positive influenza test result at Day 0 from qualitative PCR testing on the team collected sample, the laboratory then performed qPCR testing of self-collected samples to quantify viral shedding.|At Day 3|The population analyzed was restricted to the 455 participants who had a confirmed positive test (from team collected sample) for influenza in the central laboratory testing and were not in the pilot study for IRC004. 9 participants (4 in the Oseltamivir arm and 5 in the Placebo arm) had missing endpoint samples so were excluded from the analysis.|||Participants|||Count of Participants
2690787|NCT01314911|Secondary|28-day Mortality|Number of deaths|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Participants|||Count of Participants
2690817|NCT01314716|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.|||units on a scale||Standard Deviation|Mean
2690788|NCT01314911|Secondary|Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, After Day 0.|Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.|||percentage of participants|||Number
2690789|NCT01314911|Secondary|Percentage of Participants Who Required Hospitalization.|The percentage of participants hospitalized by 28 days was constructed by inverting an exact binomial test of the actual percentages (ignoring loss to follow-up).|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2690790|NCT01314911|Secondary|Number of Participants With Treatment Compliance Status|For each of the 5 days of treatment, participants were asked whether they took all study drug for that day. All participants were assumed to have taken at least some study drug even if they had zero days with all study drug reported as taken. Missing reports for some or all days were imputed as not having taken all study drug for the days concerned.|From treatment initiation to Day 5|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Participants|||Count of Participants
2690791|NCT01314911|Secondary|Time to Return of Physical Function to Pre-illness Level|Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment). For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||days||95% Confidence Interval|Median
2690792|NCT01314911|Secondary|Time to Return to Pre-influenza Function|Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||days||95% Confidence Interval|Median
2690793|NCT01314911|Secondary|Time to Feeling as Good as Before the Onset of the Influenza Illness|Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||days||95% Confidence Interval|Median
2690794|NCT01314911|Secondary|Time to Resolution of All Symptoms AND Fever|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.|||days||95% Confidence Interval|Median
2690795|NCT01314911|Secondary|Time to Absence of Fever|Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||days||95% Confidence Interval|Median
2690804|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Micturitions at Week 52|Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Micturitions||95% Confidence Interval|Least Squares Mean
2690796|NCT01314911|Secondary|Time to Alleviation of Influenza Clinical Symptoms|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms was defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms were grade 0 (absent) or 1 (mild). A measurement was considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements were obtained per day) and then the daily assessment thereafter. Time was calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfied this criterion, then the duration was set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||days||95% Confidence Interval|Median
2690797|NCT01314911|Secondary|Number Of Participants Shedding Virus -- Team Collected Samples|Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).|At day 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
2690798|NCT01314911|Secondary|qPCR Viral Shedding -- Team Collected Samples|Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)|At Day 0, 3 and 7|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed (from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||log10 copies/mL||Inter-Quartile Range|Median
2690799|NCT01314911|Secondary|Number of Participants by Virus Detection Status--Team Collected Samples|Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ|At Day 0, 3 and 7|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed(from team collected sample) in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
2690800|NCT01314911|Primary|Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples|The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.|At Day 3|The population analyzed was restricted to the 455 participants who had a confirmed positive test (from team collected sample) for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC004. 6 participants (3 in each arm) had missing endpoint samples so were excluded from the analysis.|||Participants|||Count of Participants
2690801|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Strong urge episodes||95% Confidence Interval|Least Squares Mean
2690802|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Incontinence episodes||95% Confidence Interval|Least Squares Mean
2690803|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
2690816|NCT01314716|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.|||units on a scale||Standard Deviation|Mean
2690848|NCT01314313|Secondary|Effective Orifice Area (EOA)||2 years|Effective Orifice Area is listed for only the patients who had echo available at the follow-up visit.|||cm^2||Standard Deviation|Mean
2690805|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Strong urge episodes||95% Confidence Interval|Least Squares Mean
2690806|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Incontinence episodes||95% Confidence Interval|Least Squares Mean
2690807|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
2690808|NCT01314872|Primary|Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 52 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2690809|NCT01314872|Primary|Extension Study: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 54 weeks (including 2-week follow-up)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2690810|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2690811|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2690812|NCT01314872|Primary|Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Micturitions||95% Confidence Interval|Least Squares Mean
2690813|NCT01314742|Primary|Duration of Mechanical Ventilation|Time on invasive mechanical ventilation will be measured in days|3 days||||ventilator-days||Standard Deviation|Mean
2690814|NCT01314742|Primary|Feasibility|percentage of participants with retention|duration of study, for up to 30 months||||percentage of participants retained|||Number
2690815|NCT01314716|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.~Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough~Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set|||days||95% Confidence Interval|Median
2690818|NCT01314703|Primary|Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.|the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.|10 minutes after single application of test material|27 subjects were treated with ChloraPrep on the abdomen and groin treatment sites. 26 of the 27 abdomen sites met the qualifying bacterial baseline count and were included in the analysis. 25 of the groin sites met the qualifying bacterial baseline count and were included in the analysis.|||log 10 colony forming units||95% Confidence Interval|Mean
2690819|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.|Plasma measurements of malondialdehyde, a marker of lipid peroxidation was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation|Day 0 and 7 of intervention||||microM||Standard Error|Mean
2690820|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.|Plasma measurements of gamma-tocopherol was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation.|Day 0 and 7 of intervention||||microM||Standard Error|Mean
2690821|NCT01314443|Primary|Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0|Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = [(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion]*100.|Day 0 and 7 of intervention|Analysis was performed on all participants completing the 7 d intervention|||% of preocclusion diameter||Standard Error|Mean
2690822|NCT01314417|Secondary|Cytokine Analysis on Aqueous Samples to Assess Whether Intravitreal Injection of Methotrexate Affects Aqueous Inflammatory Cytokine Levels|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and Week 74|As this study terminated early due to lack of recruitment, data were not collected for this outcome.||||||
2690823|NCT01314417|Secondary|Observation of Dose Reduction of Systemic Immunosuppression or Steroids Over the Course of the Study Period|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and Week 74|As this study terminated early due to lack of recruitment, data were not collected for this outcome.||||||
2690824|NCT01314417|Secondary|Number of Participants Experiencing a Complete Resolution of Fluid as Seen on OCT at Any Time During the Study Period||Baseline and Week 74||||participants|||Number
2690825|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 24 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||participants|||Number
2690826|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 12 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||participants|||Number
2690827|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 24 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||participants|||Number
2690828|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 12 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||participants|||Number
2690829|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 20 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20||||ETDRS Letters|Eyes|Standard Deviation|Mean
2691610|NCT01308918|Secondary|Correlation Between the Difficult Intubation Score and a Successful Intubation||1 hour (Post intubation)|||||||
2690830|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||ETDRS Letters||Standard Deviation|Mean
2690831|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 16 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16||||ETDRS Letters|Eyes|Standard Deviation|Mean
2690832|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||ETDRS Letters|Eyes|Standard Deviation|Mean
2690833|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 8 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8||||ETDRS Letters|Eyes|Standard Deviation|Mean
2690834|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 4 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4||||ETDRS Letters|Eyes|Standard Deviation|Mean
2690835|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 24 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||µm|Eyes|Standard Deviation|Mean
2690836|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 20 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20||||µm|Eyes|Standard Deviation|Mean
2690837|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 16 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16||||µm|Eyes|Standard Deviation|Mean
2690838|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 12 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||µm|Eyes|Standard Deviation|Mean
2690839|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 8 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8||||µm|Eyes|Standard Deviation|Mean
2690840|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 4 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4||||µm|Eyes|Standard Deviation|Mean
2690841|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 24 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||percentage of change from baseline||Standard Deviation|Mean
2690842|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 20 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20||||percentage of change from baseline||Standard Deviation|Mean
2690843|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 16 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16||||percentage of change from baseline||Standard Deviation|Mean
2690844|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 12 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||percentage of change from baseline||Standard Deviation|Mean
2690845|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 8 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8||||percentage of change from baseline||Standard Deviation|Mean
2690846|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 4 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4||||percentage of change from baseline||Standard Deviation|Mean
2690847|NCT01314417|Primary|Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.|"Treatment success is defined as achieving at least a 1-step decrease in the LogScore scale for central macular thickness.~A decrease of at least 1-step on the logOCT scale, where Change in logOCT=log(follow-up thickness/200) - log(baseline thickness/200) is considered clinically significant. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness and represents greater than twice the variability of retinal thickness measurements (approximately 25-30 µ).~Examples of OCT measurements with their corresponding LogScore, where LogScore=10xlogOCT are as follows:~LogScore 0 = OCT 200 µm, LogScore 1 = OCT 250 µm, LogScore 2 = OCT 320 µm, LogScore 3 = OCT 400 µm, LogScore 4 = OCT 500 µm, LogScore 5 = OCT 640 µm, LogScore 6 = OCT 800 µm, LogScore 7 = OCT 1000 µm"|12 weeks||||Participants|||Number
2691611|NCT01308918|Secondary|Number of Attempt to Obtain a Successful Intubation||1 hour (Post intubation)||||Attempts|||Number
2690849|NCT01314313|Secondary|NYHA Classification at 2 Years|New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.|2 years||||units on a scale||Standard Deviation|Mean
2690850|NCT01314313|Secondary|6MWT Change From Baseline|Six Minute Walk Test change from baseline to 2 years|Baseline and 2 years||||meters||Standard Deviation|Mean
2690851|NCT01314313|Secondary|Total Aortic Regurgitation (AR) at 2 Years|"Total aortic regurgitation was assessed by the core lab as Grade 0 = None, Grade 1+ = Trace, Grade 2+ = Mild, Grade 3+ = Moderate and Grade 4+ = Severe. Total regurgitation at two year was analyzed in the valve implant population."|2 years|All randomized patients who received the valve were analyzed. Note: Echos were not available for all the patients who made the follow-up visit.|||Grade||Standard Deviation|Mean
2690852|NCT01314313|Secondary|Adjusted Days Alive and Out of Hospital (DAOH) to Two Years|The number of days the patients are alive and out of the hospital.|2 years|Intent to Treat Population: All randomized patients with the exception of Total Aortic Regurgitation and Effective Orifice Area which was analyzed with the Valve Implant Population: All randomized patients receiving the valve.|||days||Standard Deviation|Mean
2690853|NCT01314313|Primary|All-cause Death or Disabling Stroke to Two Years|All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)|2 Years|Participants include all patients who were randomized.|||Participants|||Count of Participants
2690854|NCT01314261|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.|Week 4 through Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
2690855|NCT01314261|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Full Range|Median
2690856|NCT01314261|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Full Range|Median
2690857|NCT01314261|Secondary|Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days.|Approximately 12 weeks|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||Days||95% Confidence Interval|Median
2690858|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.|24 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
2690859|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.|12 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
2690860|NCT01314261|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.|||percentage of participants|||Number
2690871|NCT01314105|Secondary|Incidence and Intensity of Adverse Events|"Safety of nintedanib as indicated by intensity and incidence of adverse events, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.~The CTCAE grades are the worst grade per patient. The CTCAE grades are Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as lifethreatening or disabling AE, and Grade 5 as death related to AE."|From the first drug administration until 28 days after the last drug administration, up to 31 months|Treated Set|||participants|||Number
2690861|NCT01314261|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng*hr/mL||Standard Deviation|Mean
2690862|NCT01314261|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||Hours||Standard Deviation|Mean
2690863|NCT01314261|Primary|Maximum Plasma Concentration (Cmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2690864|NCT01314261|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.|Baseline and Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
2690865|NCT01314261|Primary|Percentage of Participants With 4-week Rapid Virologic Response (RVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.|Week 4|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.|||percentage of participants|||Number
2690866|NCT01314118|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.|End of Cycle 3 (Approximately Month 3)|Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.|||Percentage of Participants||95% Confidence Interval|Number
2690867|NCT01314118|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
2690868|NCT01314118|Secondary|Time to Radiographic Evidence of Disease Progression (TTRP)|Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
2690869|NCT01314118|Primary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.|End of core study visit (Approximately at Month 6)|Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.|||Percentage of participants||95% Confidence Interval|Number
2690870|NCT01314105|Secondary|Change From Baseline in Safety Laboratory Parameters|Change from baseline in safety laboratory parameters.|From the first drug administration until 28 days after the last drug administration, up to 31 months|Treated Set|||percentage of participants|||Number
2698570|NCT01255137|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module.|3/2/11 - 8/2/12||||Participants|||Number
2690872|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of PLD (Determined as Plasma Doxorubicinol)|"The maximum measured plasma concentration (Cmax) of pegylated liposomal doxorubicin (PLD) (determined as plasma doxorubicinol).~Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.||||||
2690873|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of PLD (Determined as Plasma Doxorubicinol)|"Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of pegylated liposomal doxorubicin (PLD) (determined as plasma doxorubicinol).~Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.||||||
2690874|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of PLD (Determined as Plasma Doxorubicinol)|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of pegylated liposomal doxorubicin (PLD) (determined as plasma doxorubicinol).~Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.||||||
2690875|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of PLD (Determined as Total Plasma Doxorubicin) During Treatment Course 1 and Course 2|"The maximum measured plasma concentration (Cmax) of pegylated liposomal doxorubicin (PLD) (determined as total plasma doxorubicin) during treatment course 1 and course 2.~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 1 as for only 2 patients evaluable concentrations were available."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2690876|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of PLD (Determined as Total Plasma Doxorubicin) During Treatment Course 1 and Course 2|"Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of pegylated liposomal doxorubicin (PLD) (determined as total plasma doxorubicin) during treatment course 1 and course 2.~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 1 as for only 2 patients evaluable concentrations were available."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2690877|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of PLD (Determined as Total Plasma Doxorubicin) During Treatment Course 1 and Course 2|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of pegylated liposomal doxorubicin (PLD) (determined as total plasma doxorubicin) during treatment course 1 and course 2.~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 1 as for only 2 patients evaluable concentrations were available."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2690886|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of nintedanib during course 1 and course 2|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of nintedanib and who had at least one valid pharmacokinetic parameter concentration available|||nanogram*hour/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2690878|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of Carboplatin During Course 1 and Course 2 (Determined as Ultrafilterable Platinum)|Maximum measured plasma concentration (Cmax) of carboplatin during course 1 and course 2 (determined as ultrafilterable platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2690879|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of Carboplatin (Total Platinum)|Maximum measured plasma concentration (Cmax) of carboplatin during course 1 and course 2 (determined as total platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2690880|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Ultrafilterable Platinum)|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of carboplatin during course 1 and course 2 (determined as ultrafilterable platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2690881|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Total Platinum)|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of carboplatin during course 1 and course 2 (determined as total platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2690882|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of Carboplatin During Treatment Course 1 and Course 2 (Determined as Ultrafilterable Platinum)|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of carboplatin during treatment course 1 and course 2 (determined as ultrafilterable platinum).~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 2 as 2/3 of patients had quantifiable values."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2690883|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carboplatin (Determined as Total Platinum)|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of carboplatin (determined as total platinum) during treatment course 1 and course 2.|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2690884|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of Nintedanib|Maximum measured plasma concentration (Cmax) of nintedanib during course 1 and course 2|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2690885|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Nintedanib|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of nintedanib during course 1 and course 2.|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2690896|NCT01314001|Primary|7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)|The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 11|Intent-to-treat population (all subjects who received at least one dose of intervention).|||percentage of ITT subjects|||Number
2690887|NCT01314105|Primary|Dose Limiting Toxicities During Treatment Course 1|"Number of patients with dose limiting toxicity (DLT) occurring during treatment course 1~The following AEs were to be reported as DLT events if their occurrence was considered to be drug-related:~Haematological toxicity:~Any CTCAE grade 4 haematological toxicity~CTCAE grade 4 neutropenia that was not associated with fever ≥38.5°C, if persisting for >7 days despite adequate supportive treatment~CTCAE grade ≥3 neutropenia of any duration if associated with fever ≥38.5°C~Any CTCAE grade 4 thrombocytopenia~CTCAE grade ≥3 thrombocytopenia if associated with bleeding of CTCAE grade ≥2~Non-haematological toxicity:~CTCAE grade ≥3 diarrhoea despite optimal medical management~CTCAE grade 2 diarrhoea persisting for more than 7 days despite optimal medical management~CTCAE grade ≥2 vomiting despite optimal medical management~ALT and/or AST elevation of CTCAE grade ≥3~ALT and/or AST elevation of >3x ULN in conjunction with bilirubin increase >2x ULN"|First 28-day treatment cycle|MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period|||participants|||Number
2690888|NCT01314105|Primary|Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1|Maximum Tolerated Dose (MTD) of nintedanib in combination with carboplatin and pegylated liposomal doxorubicin based on the occurrence of dose limiting toxicities (DLTs) during treatment course 1. MTD will be determined among the first 6 evaluable patients in each dose level. MTD is the highest dose at which the incidence of DLT is less than 2/6.|First 28-day treatment cycle|MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period|||mg|||Number
2690889|NCT01314014|Secondary|Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas|Measured from start of treatment until disease progression or death from any cause.|up to 25 months|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.|||months||Full Range|Median
2690890|NCT01314014|Primary|Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas|CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if >= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) [18F]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|One year|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.|||percentage of participants||95% Confidence Interval|Number
2690891|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 4|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 4|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
2690892|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 1|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 1|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
2690893|NCT01314001|Secondary|Total Side-Effect Severity Index at Target Quit Date|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Target Quit Date (Week 0)|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
2690894|NCT01314001|Secondary|Total Side-Effect Severity Index at Pre-Quit|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Pre-Quit (Week -1/Baseline)|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
2690895|NCT01314001|Secondary|7-day Point Prevalence Quit Rate at 6-month Follow up Survey|The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 24|Intent-to-treat population (all subjects who received at least one dose of intervention).|||percentage of ITT subjects|||Number
2690897|NCT01313936|Secondary|Changes in Standardized Uptake Values on FDG-PET Scans|To describe changes in standardized uptake values (SUVs) obtained by 18FDG-PET scan at study entry and in response to one cycle of protocol therapy.|One year|No PET scans were performed during this trial.||||||
2690898|NCT01313936|Secondary|Changes in Diarrhea|Rate of protocol associated diarrhea according to UGT1A1 genotype.|One year||||Participants|||Count of Participants
2690899|NCT01313936|Secondary|Therapeutic Response Rate|Therapeutic response rate to regimen according to the NANT modified-version of the International Neuroblastoma Response Criteria.|6 weeks||||Participants|||Count of Participants
2690900|NCT01313936|Primary|Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability|To determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a 5-day schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.|6 weeks||||participants with DLT|||Number
2690901|NCT01313923|Secondary|Statistical Measures|"The statistical goal is to observe success, an improvement in disease control while up-titrating sirolimus dosage. As there will be no control group, the subject or progress at the end of the study will be compared to their baseline at the beginning of the study. The subject and disease severity at the beginning of the study will be compared to the disease severity at each visit and be correlated with the dosage of sirolimus and corticosteroid. However, since no patient completed the study, the outcome and any data collected was not assessed."|Study early termination by investigator - no participant completed any visits of the study - no measurements taken|||||||
2690902|NCT01313923|Primary|Improvement of ABSIS Score While Reducing Steroid Dosage|"Measurement of disease severity will be quantified using ABSIS (Autoimmune Bullous Skin Disorder Intensity Score). Improvement in disease control is quantified by the maintenance or improvement of ABSIS score while reducing steroid dosage.~No results as study has been terminated early by the investigator."|Expected time line 24 months|This outcome was not assessed because no participant completed any visits of the study||||||
2690903|NCT01313910|Secondary|Duodenal Immune Reconstitution|changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry|8 weeks||||CD3+/CD4+ per mm^2 lamina propria||Inter-Quartile Range|Median
2690904|NCT01313910|Secondary|Systemic Immune Activation|CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)|8 weeks||||% CD8/HLA-DR/CD38+||Inter-Quartile Range|Median
2690905|NCT01313910|Secondary|Measures of Gut Permeability|five-hour disaccharide absorption test|8 weeks||||percentage absorption||Inter-Quartile Range|Mean
2690906|NCT01313910|Secondary|Frequency of Pro-inflammatory Bacterial Orders|16S rDNA sequencing for Bacteroidetes/Firmicutes ratio|8 weeks||||ratio of Bacteroidetes/Firmicutes %||Inter-Quartile Range|Median
2690907|NCT01313910|Primary|Number of Bowel Movements Per Day|self-reported bowel movement in diary|8 weeks (56 days)||||bowel movements/day||Inter-Quartile Range|Median
2690908|NCT01313897|Primary|Therapeutic Efficacy|Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: >= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND >= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if >= 30% plasma cells at baseline); AND >=50% reduction in serum M protein and reduction in urine M protein >= 90% or to 200 mg/24hr OR >= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein < 1 g/dL, urine < 200 mg/24 hrs, and an involved serum free light chain level >= 10 mg/dL at baseline).|180 days||||Participants|||Count of Participants
2690909|NCT01313884|Secondary|Progression-free Survival (PFS)|The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.|24 months|All study participants were lost to follow-up after completion of active treatment and collection of response rate, ie, within 2 years of the treatment conclusion but before documented progression. No data.||||||
2690910|NCT01313884|Primary|Overall Response Rate (Partial and Complete Response)|"Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.~Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters."|Up to 24 months||||Participants|||Count of Participants
2690911|NCT01313858|Primary|Number of Participants Who Experienced at Least One Serious Adverse Event|A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.|||Participants|||Number
2690912|NCT01313858|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.|||Participants|||Number
2690925|NCT01313767|Secondary|DAS(Disability Assessment Scale) of Pain|"Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Pain.~The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability)."|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 4 subjects receiving Meditoxin and 2 Botox.|||Scores on a DAS Scale||Standard Deviation|Mean
2690913|NCT01313858|Primary|Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement."|Baseline and Months 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
2690914|NCT01313858|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.|Baseline and Months 3, 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
2690915|NCT01313858|Primary|Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score|The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH[%] = (Attained score*100)/(2*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.|Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
2690916|NCT01313858|Primary|Clinical Global Impression (CGI) Disease Status|"The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from 0 (free of complaints) to 10 (strong discomfort). The closer the score to 0, the better the health status."|Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
2690917|NCT01313780|Secondary|Change in Bowel Habits.|The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as 'improved', 'unchanged', and 'worsened'.|4 weeks|FAS analysis, but Oxycodone/naloxone group was missed 15 patients data and Oxycodone group was missed 23 patients data.|||participants|||Number
2690918|NCT01313780|Primary|Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)|Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .|4weeks|Analysis of FAS: 117.|||units on a scale||Standard Deviation|Mean
2690919|NCT01313767|Secondary|Carer Burden Scale of Cleaning the Armpit|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.|||Scores on a Carer Burden Scale||Standard Deviation|Mean
2690920|NCT01313767|Secondary|Carer Burden Scale of Putting Shirts on|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.|||Scores on a Carer Burden Scale||Standard Deviation|Mean
2690921|NCT01313767|Secondary|Carer Burden Scale of Cutting the Finger-nails|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.|||Scores on a Carer Burden Scale||Standard Deviation|Mean
2690922|NCT01313767|Secondary|Carer Burden Scale of Cleaning the Palm|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.|||Score on a Carer Burden Scale||Standard Deviation|Mean
2690923|NCT01313767|Secondary|Global Assessment by Patient or Caregiver|Global assessment evaluated by patient or caregiver at week 12 after injection|week 12|The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.|||participants|||Number
2690924|NCT01313767|Secondary|Global Assessment by Investigator|Global assessment evaluated by investigator at week 12 after injection|week 12|The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.|||participants|||Number
2690988|NCT01313559|Secondary|Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria|Progression free survival (PFS) based on primary outcome criteria for disease progression. Patients without radiographic disease progression who permanently discontinue the study drugs will be censored|Assessed up to 30 days after completion of study treatment||||participants|||Number
2690989|NCT01313559|Secondary|Number of Participants Without New Bone Lesions After 12 Weeks of Treatment||After 12 weeks of treatment||||participants|||Number
2690926|NCT01313767|Secondary|DAS(Disability Assessment Scale) of Limb Position|"Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Limb Position.~The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability)."|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 40 subjects receiving Meditoxin and 47 Botox.|||Scores on a DAS Scale||Standard Deviation|Mean
2690927|NCT01313767|Secondary|DAS(Disability Assessment Scale) of Dressing|Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 11 subjects receiving Meditoxin and 15 Botox.|||Scores on a DAS Scale||Standard Deviation|Mean
2690928|NCT01313767|Secondary|DAS(Disability Assessment Scale) of Hygiene|"Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Hygiene.~The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability)."|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 39 subjects receiving Meditoxin and 34 Botox.|||Scores on a DAS Scale||Standard Deviation|Mean
2690929|NCT01313767|Secondary|Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor|"Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor.~* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site."|week 4, week 8, week 12|The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox.|||Subjects who improved 1-point on MAS|||Number
2690930|NCT01313767|Secondary|Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor|"Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor.~* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site."|week 4, week 8, week 12|The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox.|||Subjects who improved 1-point on MAS|||Number
2690931|NCT01313767|Secondary|Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor|"Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor.~* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site"|week 4, week 8, week 12|The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox.|||Subjects who improved 1-point on MAS|||Number
2690932|NCT01313767|Secondary|Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor|"Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor.~* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site."|week 4, week 8, week 12|The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.|||Subjects who improved 1-point on MAS|||Number
2690933|NCT01313767|Secondary|MAS(Modified Ashworth Score) of Thumb Flexor|"Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS.~The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 54 subjects receiving Meditoxin and 58 Botox.|||Scores on a MAS Scale||Standard Deviation|Mean
2690934|NCT01313767|Secondary|MAS(Modified Ashworth Score) of Finger Flexor|"Change from baseline at week 4, week 8 and 12 for finger flexor muscle tone as measured on the MAS(Modified Ashworth Scale).~The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 82 subjects receiving Meditoxin and 83 Botox.|||Score on a MAS Scale||Standard Deviation|Mean
2690935|NCT01313767|Secondary|MAS(Modified Ashworth Score) of Elbow Flexor|"Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale).~The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Baseline, week 4, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 87 subjects receiving Meditoxin and 94 Botox.|||Scores on a MAS Scale||Standard Deviation|Mean
2690936|NCT01313767|Secondary|MAS(Modified Ashworth Scale) of Wrist Flexor|"Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale).~The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Baseline, week 8 and week 12|The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.|||Scores on a MAS scale||Standard Deviation|Mean
2690990|NCT01313559|Secondary|Number of Participants With > 50% Decline From Baseline PSA Level||After 12 weeks of treatment||||participants|||Number
2690937|NCT01313767|Primary|MAS(Modified Ashworth Scale) of Wrist Flexor|Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Baseline and 4 weeks|The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 subjects for Botox.|||Scores on a MAS Scale||Standard Deviation|Mean
2690938|NCT01313728|Secondary|Facial Tolerance|All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).|Baseline to 2 Weeks||||Scores on a Scale|||Number
2690939|NCT01313728|Secondary|Subject Assessment - Tightness|Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
2690940|NCT01313728|Secondary|Subject Assessment - Itching|Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
2690941|NCT01313728|Secondary|Subject Assessment - Burning/Stinging|Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
2690942|NCT01313728|Primary|Expert Grader Assessment - Dryness|Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
2690943|NCT01313728|Primary|Expert Grader Assessment - Erythema|Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
2690944|NCT01313689|Secondary|Mean Health Change Questionnaire (HCQ) Score|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..|From the randomization date up to 60 months post the randomization date.|"Population Description:~Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation."|||Unit on a scale||Standard Deviation|Mean
2690945|NCT01313689|Secondary|Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.|||unit on a scale||Standard Deviation|Mean
2690946|NCT01313689|Secondary|Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.|From the randomization date up to 60 months post the randomization date.|Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.|||Participants|||Number
2699755|NCT01247363|Secondary|Number of Hypoglycemic Events|Number of hypoglycemia events with blood glucose concentration <70 milligram/deciliter (mg/dL).|Day 1 through Day 29|Participants who were administered study drug.|||events|||Number
2690947|NCT01313689|Secondary|Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time|Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU). A cycle is defined as the time between one round of treatment until the start of the next round.|Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.|||Gram per liter||Standard Deviation|Mean
2690948|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE) of Special Interest|AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.|||Participants|||Number
2690949|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.|||Participants|||Number
2690950|NCT01313689|Secondary|Duration of Response as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.|||Months||95% Confidence Interval|Median
2690951|NCT01313689|Secondary|Time to Response as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only responders (CR, CRi, PR, nPR) were included in the analysis. Response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Months||95% Confidence Interval|Median
2690952|NCT01313689|Secondary|Time to Next Anti-cancer Therapy by Investigator|Time to next therapy is defined as the time from randomization until the start of the next line of treatment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.|||Months||95% Confidence Interval|Median
2690953|NCT01313689|Secondary|Time to Progression as Assessed by IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.|||Months||95% Confidence Interval|Median
2690954|NCT01313689|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.|||Months||95% Confidence Interval|Median
2690955|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the Investigator|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.|||Participants|||Number
2690956|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.|||Participants|||Number
2690957|NCT01313689|Secondary|Progression-free Survival (PFS) as Assessed by Investigator|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.|||Months||95% Confidence Interval|Median
2690958|NCT01313689|Primary|Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.|||Months||95% Confidence Interval|Median
2690959|NCT01313676|Secondary|Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date|On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.|From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)|ITT-E Population|||Participants|||Number
2690960|NCT01313676|Secondary|Decline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.|From start date of IP until IP stop date + 1 (assessed up to 4 years)|ITT-E Population|||milliliter/year||Standard Error|Least Squares Mean
2690991|NCT01313559|Primary|Number of Participants Alive and Progression Free After 12 Weeks of Treatment|Progression of disease is defined as disease progression by RECIST 1.1 criteria on CT scan (X-ray computed tomography), or appearance of > 2 new bone lesions on bone scan, or prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria or death from any cause.|12 weeks after treatment||||participants|||Number
2691436|NCT01309893|Primary|Distance High Contrast logMAR Visual Acuity at 1 Week|Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week|Baseline & 1 week|All eligible, dispensed eyes|||logMAR|Participants|Standard Deviation|Least Squares Mean
2690961|NCT01313676|Primary|Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date|Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.|From the date of randomization until date of death due to any cause (average of 2 study years)|ITT-E Population|||Participants|||Number
2690962|NCT01313663|Secondary|Number of Participants With the Indicated Changes From Baseline Value in Lactate Dehydrogenase (LDH)|"Change from Baseline in the laboratory parameter LDH was assessed as decrease to low, change to normal of no change, and increase to high. Participants with missing Baseline values were assumed to have a normal Baseline value. There is no standard normal range for LDH."|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
2690963|NCT01313663|Secondary|Number of Participants With the Indicated Grade Changes From Baseline Grade in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos.), and Total Bilirubin (TB)|The laboratory parameters AST, ALT, Alk. Phos., and TB were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for any grade increase, increase to Grade 3, and increase to Grade 4. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. AST/ALT: Grade 1, >upper limit of normal (ULN) - 3.0x ULN; Grade 2, >3.0 to 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, not available (NA). Alk. Phos.: Grade 1, >ULN - 2.5x ULN; Grade 2, >2.5 - 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, NA. TB: Grade 1, >ULN - >1.5x ULN; Grade 2, >1.5 - 3.0x ULN; Grade 3, >3.0 - 10.0x ULN; Grade 4, >10.0x ULN; Grade 5, NA.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
2690964|NCT01313663|Secondary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Laboratory Parameters|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Lymphocyte count increased: Grade 3, <500 - 200/millimeters cubed (mm^3); <0.5 - 0.2x 10e9/Liters (L); Grade 4, <200/mm^3; <0.2x 10e9/L. Lymphocyte count decreased: Grade 3, >20000/mm^3; Grade 4, NA. Hyperglycemia; Grade 3, >250 - 500 milligrams per deciliter (mg/dL); >13.9 - 27.8 millimoles per Liter (mmol/L); hospitalization indicated; Grade 4, >500 mg/dL; >27.8 mmol/L; life-threatening consequences. Hypophosphatemia (inorganic phosphorus): Grade 3, <2.0 - 1.0 mg/dL, <0.6 - 0.3 mmol/L; Grade 4, <1.0 mg/dL, <0.3 mmol/L, life-threatening consequences.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
2690965|NCT01313663|Secondary|Number of Participants With a Increase From Baseline in Bazett's QTc at the Indicated Time Points|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In clinical studies with pazopanib, events of QT prolongation have occurred.|Baseline; Week 6; Week 15; every 9 weeks in the first 6 months; every 12 weeks in the next 6 months; and, after 1 year, every 6 months (up to Study Week 55)|Safety Population|||participants|||Number
2690966|NCT01313663|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure (BP) were measured. Categories correspond to the following Common Terminology Criteria for Adverse Events (CTCAE) grades: normal, <120/80 millimeters of mercury (mmHg); prehypertension, 120-139/80-89 mmHg, warranting intervention in participants with high risk; stage I hypertension, 140-159/90-99 mmHg, warranting intervention; and stage II hypertension >/=160/100, warranting immediate attentive intervention to prevent acute symptoms. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Participants with a missing Baseline value were assumed to have a Baseline value of <120 for systolic BP (SBP) and <80 for diastolic BP (DBP).|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
2690967|NCT01313663|Secondary|Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Management of AEs may require DRs/interruptions in study treatment. If necessary, the pazopanib dose should be reduced stepwise by 200 mg at each step. DRs for pemetrexed were 50-75% of prior dose based on the toxicity leading to DR.|From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55)|Safety Population|||participants|||Number
2691013|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percent FEV1/FVC||Full Range|Median
2690968|NCT01313663|Secondary|Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. A participant cold have been withdrawn fom study treatment due to an SAE or AE.|From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55)|Safety Population|||participants|||Number
2690969|NCT01313663|Secondary|Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure|"The average dose of pemetrexed for all cycles, as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The average dose was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population|||milligrams per meters squared (m^2)||Standard Deviation|Mean
2690970|NCT01313663|Secondary|Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure|"Duration of therapy/time on study treatment, measured as the mean number of pemetrexed dosing cycles as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The mean number of dosing cycles was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population|||number of cycles||Standard Deviation|Mean
2690971|NCT01313663|Secondary|Mean Daily Dose, as a Measure of Extent of Exposure|"Mean daily dose, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Mean daily dose was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population|||milligrams||Standard Deviation|Mean
2690972|NCT01313663|Secondary|Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure|"Time on study treatment, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Time on study treatment was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population|||months||Standard Deviation|Mean
2690973|NCT01313663|Secondary|Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.|||participants|||Number
2690974|NCT01313663|Secondary|Number of Participants (Par.) With the Indicated Best Overall Response|A par. was defined as a responder if s/he sustained a CR (The disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters) that was confirmed after >=28 days. Response was evaluated by an investigator per RECIST, version 1.1. A par. without a post-Baseline assessment was considered a non-responder. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started). To qualify as a best response of SD, a response of SD had to be observed >=12 weeks after randomization. A par. who was not evaluable had no scans at all or did not have a confirmatory scan.|From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks)|ITT Population|||participants|||Number
2690975|NCT01313663|Secondary|Overall Survival|Overall survival is defined as the interval between the date of randomization and the date of death from any cause.|From randomization until disease progression or death (up to Study Week 78)|The study size (20 participants) and follow up were not adequate to assess overall survival. Participants who had not died at the time of the cut-off for the analysis were to be censored at the date the particpant was last known to be alive.||||||
2699756|NCT01247363|Secondary|Time to Maximum Drug Concentration (Tmax)||Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose|Participants who were administered study drug.|||hour||Full Range|Median
2690976|NCT01313663|Primary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the first documented sign of investigator-assessed (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) disease progression (PD) or death, whichever occurs first. The date of documented PD is the date of lesion evaluation in the case of radiological PD and the date of symptomatic cancer progression in the case of symptomatic progression (radiological confirmation is required). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was to be censored at the last adequate assessment (LAA) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of progression or death, PFS was to be censored at the date of the LAA.|From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered|||weeks||90% Confidence Interval|Median
2690977|NCT01313650|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2690978|NCT01313650|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690979|NCT01313650|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2690980|NCT01313650|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2691014|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percent FEV1/FVC||Full Range|Median
2690981|NCT01313637|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2690982|NCT01313637|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690983|NCT01313637|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2690984|NCT01313637|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2690985|NCT01313624|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.~Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough~Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set|||days||95% Confidence Interval|Median
2690986|NCT01313624|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.|||units on a scale||Standard Deviation|Mean
2690987|NCT01313624|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.|||units on a scale||Standard Deviation|Mean
2691437|NCT01309880|Secondary|Comfort|At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.|1 Weeks||||units on a scale|Participants|Standard Deviation|Least Squares Mean
2690992|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.|"DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual~endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic."|Baseline and Week 14|Participants treated with Infliximab or placebo|||Z-score||95% Confidence Interval|Least Squares Mean
2690993|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.|Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.|Baseline and Week 14|Participants treated with Infliximab or placebo|||Z-score||95% Confidence Interval|Least Squares Mean
2690994|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Osteitis.|RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo. One participant in the placebo group missing a baseline value was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2690995|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Synovitis.|RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo|||units on a scale||Standard Deviation|Mean
2690996|NCT01313520|Other Pre-specified|Change From Baseline in DAS28 CRP.|DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo|||units on a scale||95% Confidence Interval|Least Squares Mean
2690997|NCT01313520|Secondary|Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).|ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP.|Baseline and week 14|Participants treated with Infliximab or placebo|||percentage of responders||90% Confidence Interval|Number
2690998|NCT01313520|Secondary|Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).|ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP).|Baseline and week 14|Participants treated with Infliximab or Placebo|||percentage of responders||90% Confidence Interval|Number
2690999|NCT01313520|Primary|Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)|Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).|Baseline and week 14|Participants treated with infliximab or placebo|||min ^-1||95% Confidence Interval|Least Squares Mean
2691000|NCT01313507|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug|An adverse event was considered to be temporally related to the study drug if it started during an infusion or within 72 hours after the end of an infusion.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.|||Percentage of participants|||Number
2691001|NCT01313507|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug|An adverse event was considered to be causally related to the administration of the study drug if it judged to be probably or possibly related to the study drug, as assessed by the investigator.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.|||Percentage of participants|||Number
2691002|NCT01313507|Secondary|Change From Baseline in the Quality of Life (QoL) at the End of the Study|QoL was assessed with the Child Health Questionnaire-Parent Form (CHQ-PF50), completed by a parent or guardian, in participants < 14 years of age at the start of the previous study NGAM-01 and with the Short Form-36 Health Survey (SF-36-HS) in participants ≥ 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated scores were transformed so that each scale had a range of 0-100. A higher score indicates better health. The SF-36-HS is composed of 36 items. Responses to the 36 items were combined to create 8 scales. The 8 scales could be further combined into 2 scores: Physical component summary and mental component summary. The item and scale scores were transformed to a range of 0-100 with a mean of 50 and a standard deviation of 10 in the general US population. A higher score indicates better health. For both instruments, a positive change indicates improvement.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.|||Units on a scale||Standard Deviation|Mean
2692227|NCT01303380|Secondary|Participants Who Received Rescue Treatment|Participants who experienced flares were treated with corticosteroids and NSAIDs as rescue medication.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.|||Percentage of participants|||Number
2691003|NCT01313494|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above. Each AE was assessed by the Investigator as either 'related' or 'not related' to study drug.|24 weeks|Safety population, all randomized patients who took at least 1 dose of the trial treatment after randomization.|||participants|||Number
2691004|NCT01313494|Secondary|Time to Onset of Second Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation - date of first intake of study drug + 1 day. At least 10 days between the stop date of an exacerbation and the start date of the following exacerbation was required for these to be be considered as two separate COPD exacerbations. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population who experienced a second moderate to severe COPD exacerbation.|||days||Full Range|Median
2691005|NCT01313494|Secondary|Time to Onset of First Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation - date of first intake of study drug + 1 day. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population with at least one moderate or severe exacerbation|||days||Full Range|Median
2691006|NCT01313494|Secondary|Mean Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|The mean rate of COPD exacerbations per patient per year rate = (number of exacerbations per treatment group/time to study withdrawal per treatment group) * 365. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat|||exacerbations per patient per year|||Number
2691007|NCT01313494|Secondary|Percentage of Participants With Moderate or Severe COPD Exacerbations|A COPD exacerbation is an event characterised by a worsening in the patient's baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat|||percentage of participants|||Number
2691008|NCT01313494|Secondary|Transition Dyspnoea Index (TDI) Total Score at Week 24|"The TDI is a recognized questionnaire to measure dyspnoea (shortness of breath) in patients with COPD. Questions from the TDI were used to assess the 3 components: change in functional impairment, change in magnitude of task and change in magnitude of effort. Transitions or changes from baseline are rated from -3 (major deterioration) to +3 (major improvement), and summed to give a total score ranging from -9 to +9. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables."|Baseline to Week 24|Intent-to-treat population with available data.|||units on a scale||Standard Error|Least Squares Mean
2691009|NCT01313494|Secondary|Change From Baseline in Use of Rescue Medication|Salbutamol (given by metered dose inhaler and spacer) was used as rescue medication according to the individual needs of a patient. Each use was documented in the patient's paper diary. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||puffs/day||Standard Error|Least Squares Mean
2691010|NCT01313494|Secondary|Change From Baseline in COPD Symptom Scores|Symptoms of chronic bronchitis with respect to cough and sputum production were assessed daily by the patient and recorded in a diary. Symptoms were assessed on a 4-point scale as follows: Cough: 0: no cough; 1: mild cough (at some time during the day); 2: moderate cough (regularly during the day); 3: severe cough (never free of cough or feeling free of need to cough). Sputum production: 0: no sputum production (unnoticeable); 1: mild sputum production (noticeable as a problem); 2: moderate sputum production (frequent inconvenience); 3: severe sputum production (constant problem). Change from Baseline is reported for cough and sputum separately, and for the sum of the 2 scores (range 0 - 6). Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||units on a scale||Standard Error|Least Squares Mean
2691011|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percentage of FEV1/FEV6||Full Range|Mean
2691012|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percentage of FEV1/FEV6||Full Range|Median
2691063|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)|Blood samples for MCH were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||picograms (pg)||Full Range|Mean
2691015|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/minute||Standard Error|Least Squares Mean
2691016|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/minute||Standard Error|Least Squares Mean
2691017|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691018|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691019|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691020|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691021|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/second||Standard Error|Least Squares Mean
2691022|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/second||Standard Error|Least Squares Mean
2691023|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691024|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691075|NCT01313273|Secondary|Reduction in Chromogranin A Serum Levels||Baseline, Week 96|Study early terminated due to poor enrollment||||||
2691076|NCT01313273|Secondary|Median Time to PSA Response||Week 96|Study early terminated due to poor enrollment||||||
2691025|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator FEV1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
2691026|NCT01313494|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population included all randomly assigned patients who took at least 1 dose of trial treatment after randomization. Patients were assigned to the treatment group based on the treatment to which they were randomly assigned. Only patients with available data at Baseline and with at least 1 post-baseline measurement are included.|||liters||Standard Error|Least Squares Mean
2691027|NCT01313416|Secondary|Disease Response: Evaluated Using the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (v1.1)|"Patients who have received at least one cycle of therapy will be evaluated for response every 8 weeks (every other cycle). Confirmatory scans will be obtained 4 weeks following initial documentation of objective or non-target disease response.~Response will be evaluated on target and non-target lesions. The same method of assessment and same technique will be used to characterize each identified and reported lesion at baseline and during follow-up. Response will be reported as:~Complete Response (CR); Disappearance of all target lesions~Partial Response (PR); At least 30% decrease in the sum of the diameters of target lesions~Progressive Disease (PD): At least 20% increase in the sum of the diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|2 years|Study discontinued due to drug supply issues prior to analysis; no meaningful data derived.||||||
2691028|NCT01313416|Primary|Toxicity Evaluation: From Time of First Treatment With CT-011 (Pidilizumab, MDV9300)|"Patients presenting with symptoms possibly related to autoimmune reaction will be evaluated for organ specific autoimmune involvement, i.e:~Acute abdominal symptoms should be evaluated for pancreatitis, including lipase and amylase levels;~Persistent diarrhea should be evaluated for infection (c. diff). Any suspicion of colitis should be evaluated by a colonoscopy with biopsy.~Visual symptoms should be immediately evaluated by an ophthalmologist.~Generalized rash should be biopsied prior to local skin care, antihistamines or corticosteroids.~Pulmonary symptoms will be evaluated immediately, including repeated PFTs (pulmonary function tests)."|2 years|Study discontinued due to drug supply issues prior to analysis; no meaningful data derived.||||||
2691029|NCT01313312|Secondary|Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit|Subjects were asked to complete the EQ-5D-5L QoL questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression and scored their general health state. Each dimension has 5 levels of severity (no problems, slight problems,moderate problems, severe problems and extreme problems). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean values for each dimension and the VAS scores at baseline and at the end of-study /early withdrawal are reported.|Up to Week 52|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691030|NCT01313312|Secondary|Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit|Subjects were asked to complete the SF-36 questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The SF-36 is a generic non-preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0-100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. Baseline results and the change from baseline to end of study/early withdrawal for the PCS and MCS are reported.|Up to Week 52|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691043|NCT01313312|Secondary|Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4|At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least 1 grade reduction from baseline in DAS for PTT at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Percentage of Subjects|||Number
2691031|NCT01313312|Secondary|Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4|The MFS was used to measure upper limb active function. Each subject was video taped while performing specific tasks. The videos were sent to a central provider and were read and scored by two independent readers blinded to the timing of the video and to treatment. These central assessments were used for the analysis of efficacy endpoints. The MFS consists of 10 tasks asking the subject to reach, grasp, carry and release different objects of different sizes which subjects are likely to use in their daily life. Each of these tasks was rated on a 10 point scale ranging from no movement to normal movement; for each task, the score 5 is used to rate a task barely accomplished. Mean change in MFS from baseline to Week 4 was reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691032|NCT01313312|Secondary|Mean Change From Baseline at Week 4 in Ease of Applying a Splint|The ease of applying a splint was evaluated on a 6-point scale (0= no splint needed, -1= splint needed and applied with no difficulty, -2= splint needed and applied with mild difficulty, -3= splint needed and applied with moderate difficulty, -4= splint needed and applied with severe difficulty, -5= splint needed,but unable to apply). Mean change in ease of applying a splint from baseline to Week 4 was reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691033|NCT01313312|Secondary|Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs|The AROM was assessed by the range of extension achieved by the subject moving each joint in the PTMGs (extrinsic finger flexors, elbow flexors and wrist flexors) without assistance. A goniometer was used for measurements in the elbow and wrist flexors but not for measurements in the extrinsic finger flexors. Mean changes in AROM in the 3 possible PTMGs from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691034|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors|The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691035|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors|The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
2691036|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG|The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691052|NCT01313312|Secondary|Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the extrinsic finger flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691077|NCT01313273|Secondary|Prostate Specific Antigen (PSA) Response||Week 96|Study early terminated due to poor enrollment||||||
2691037|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG|The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
2691038|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG|The TS was used to measure spasticity in elbow flexors.The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691039|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG|The TS was used to measure spasticity in elbow flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
2691040|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG|The TS was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691041|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG|The Tardieu Scale (TS) was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
2691042|NCT01313312|Secondary|Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4|The DAS is a 4-point scale. The extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least one grade reduction in DAS for each of the individual domains at Week 4 is reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
2691078|NCT01313273|Primary|Progression-free Survival||Week 96|Study early terminated due to poor enrollment.||||||
2692587|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the nondominant hand before the procedure|Before the procedure (Baseline)||||participants|||Number
2691044|NCT01313312|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4|At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The mean changes in DAS at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691045|NCT01313312|Secondary|Physician's Global Assessment (PGA) of Treatment Response at Week 4|The PGA is a 9-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. An assessment of overall treatment response was conducted by the investigator and the mean PGA scores during long-term open label treatment with Dysport were reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691046|NCT01313312|Secondary|Mean Change From Baseline MAS in the Shoulder Extensors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the shoulder extensors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691047|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the elbow flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
2691048|NCT01313312|Secondary|Mean Change From Baseline MAS in the Elbow Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the elbow flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691049|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction in mean MAS in the wrist flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
2691050|NCT01313312|Secondary|Mean Change From Baseline MAS in the Wrist Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the wrist flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691051|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the extrinsic finger flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
2691205|NCT01312779|Other Pre-specified|Subject's Average White Blood Cell Count|Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection.|Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||10^3 cells /microliter||Standard Deviation|Mean
2691053|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the overall PTMG at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of participants|||Number
2691054|NCT01313312|Secondary|Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the overall PTMG (finger, wrist or elbow flexors) are reported.|At Week 4|The Intent-to-Treat (ITT) population was all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
2691055|NCT01313312|Primary|Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies|Blood samples were collected at baseline, Week 4 of each cycle, and at the end of study/early withdrawal to test for the presence of Botulinum Toxin A Binding antibodies. Samples positive for the presence of binding antibodies were then analysed for the presence of neutralising putative antibodies. The number of subjects who were either positive (+ve) or negative (-ve) at baseline and then positive post baseline for binding or neutralising antibodies were reported.|Up to Week 52|Binding and neutralising antibodies were evaluated at baseline for all 258 subjects (rollover and de novo) enrolled in Study 148. Only subjects with data available for analysis at the point of testing are reported.|||Participants|||Number
2691056|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR|HR was measured by 12-lead ECG tracing, performed at baseline, at post treatment follow up visit Week 4, and at the end of study or early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest.|Up to Week 52|The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.|||bpm||Standard Deviation|Mean
2691057|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose|Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||millimoles(mmol)/L||Full Range|Mean
2691058|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine|Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Micromole/L (μmol/L)||Full Range|Mean
2691059|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)|Blood samples for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||International Unit/L (IU/L)||Full Range|Mean
2691060|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)|12-lead ECG tracing was performed at baseline, post treatment at Week 4 and at the end of study/early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest. The ECG parameters reported were QRS duration, PR duration, QT duration, QTcB (QT interval corrected for HR according to Bazett), and QTcF (QT interval corrected for HR according to Fridericia) at baseline and the change to end of study/early withdrawal visit (EOS).|Up to Week 52|The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.|||milliseconds (ms)||Standard Deviation|Mean
2691061|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets|Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at post treatment follow up visit Week 4, and at end of study or early withdrawal.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Giga cells/L||Full Range|Mean
2691062|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)|Blood samples for MCV were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||femtoliters (fL)||Full Range|Mean
2691064|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit|Blood samples for haematocrit were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||percentage of RBC in blood||Full Range|Mean
2691065|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)|Blood samples for haemoglobin and MCHC were taken at baseline, at post treatment follow up visit Week 4, and at the end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||grams(g)/L||Full Range|Mean
2691066|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count|Blood samples for RBC count were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Tera cells/Litre (L)||Full Range|Mean
2691067|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)|HR was recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Beats per minute (bpm)||Full Range|Mean
2691068|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)|Systolic and diastolic BP were recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Millimeters of Mercury (mm Hg)||Full Range|Mean
2691069|NCT01313312|Primary|Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)|A TEAE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any adverse event (AE) that was assessed as a hypersensitivity reaction. TEAEs, AESIs, severe TEAEs, serious adverse events (SAEs), treatment related TEAEs, TEAEs leading to withdrawal and fatal SAEs are summarised by treatment cycle.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Participants|||Number
2691070|NCT01313299|Primary|Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)|MAS scale is used to assess muscle tone using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.|From Baseline (Day 1) to Week 4|Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.|||units on a scale||Standard Deviation|Mean
2691071|NCT01313299|Secondary|Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)|"DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited).~If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3."|From Baseline (Day 1) to Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4.|||units on a scale||Standard Deviation|Mean
2691072|NCT01313299|Secondary|Physician's Global Assessment (PGA) of Treatment Response|PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).|At Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4|||units on a scale||Standard Deviation|Mean
2691073|NCT01313286|Primary|Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.|Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours|All randomized participants who took at least one dose of study drug.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2691074|NCT01313286|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])|Area under the concentration versus time curve from zero to infinity [AUC(0-∞)] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.|Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours|All randomized participants who took at least one dose of study drug.|||nanogram.hour per milliliter (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
2691079|NCT01313221|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.|32 weeks|Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.|||participants|||Number
2691080|NCT01313221|Secondary|Health Resource Utilization: Ability to Perform Daily Activities|Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores? Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.|||participants|||Number
2691081|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Missed Hours From Work|Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis? The number of participants with one or more missed hours of work per week is reported.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data; LOCF was used.|||participants|||Number
2691082|NCT01313221|Secondary|Health Resource Utilization: Productivity While Working|Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working? Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data at each time point; LOCF was used. For the Etanercept 50 mg BIW group there were 106 and 100 participants with available data at Baseline and Week 24 respectively. For the Etanercept + Topical group there were 93 and 85 participants respectively.|||participants|||Number
2691083|NCT01313221|Secondary|Health Resource Utilization: Employment Status|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants were asked their employment status at Baseline and at Week 24.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.|||participants|||Number
2691084|NCT01313221|Secondary|Health Resource Utilization: Out of Pocket Expenses|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e. costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||Canadian dollars||Inter-Quartile Range|Median
2691085|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Who Needed Friend or Family Care|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation? The number of participants who had paid or non-paid help for one or more hours is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
2691086|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Requiring Paid Help With Chores|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? The number of participants who paid for help one or more times is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
2691087|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Home Healthcare Visits|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
2691088|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician's office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
2691089|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24|The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.|Baseline and Weeks 12 and 24|Full analysis set; LOCF was used; n indicates the number of patients with available data for each scale at each time point.|||units on a scale||Standard Deviation|Mean
2691159|NCT01312961|Secondary|Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||number of awakenings/day||Standard Deviation|Mean
2691090|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24|TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable with available data; n indicates the number of patients with available data for each scale.|||units on a scale||Standard Error|Least Squares Mean
2691091|NCT01313221|Secondary|Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.|Baseline and Week 12 and Week 24|Full analysis set with available data; LOCF was used|||units on a scale||Standard Deviation|Mean
2691092|NCT01313221|Secondary|Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set with available data|||units on a scale||Standard Error|Least Squares Mean
2691093|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments.~Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement."|Baseline and Weeks 12, 16, 20, and 24|Full analysis set with available data; LOCF was used|||percent change||Standard Deviation|Mean
2691094|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.~Change was adjusted for treatment using a mixed model."|Weeks 12, 16, 20, and 24|Efficacy analysis set with available data|||percent change||Standard Error|Least Squares Mean
2691095|NCT01313221|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Weeks 12, 16, 20, and 24|Full Analysis Set, LOCF was used.|||percentage of participants||95% Confidence Interval|Number
2691096|NCT01313221|Secondary|Percentage of Participants With a PASI 90 Response|The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
2691097|NCT01313221|Secondary|Percentage of Participants With a PASI 75 Response|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
2691098|NCT01313221|Secondary|Percentage of Participants With a PASI 50 Response|The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
2691099|NCT01313221|Secondary|Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.|Baseline and Weeks 12, 16, 20, and 24|Full analysis set, (all enrolled participants who had taken at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation) and with available data. Last Observation Carried Forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2691100|NCT01313221|Secondary|Percent Change in PASI From Week 12 to Weeks 16 and 20|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12, Week 16 and Week 20|Efficacy Evaluable set with available data at each time point (indicated by n)|||percent change||Standard Error|Least Squares Mean
2691101|NCT01313221|Primary|Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set, which included all randomized participants who had taken at least 1 dose of study drug and had at least 1 post-randomization efficacy evaluation, and with available data at Week 12 and Week 24.|||percent change||Standard Error|Least Squares Mean
2691102|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691103|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691104|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691105|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691132|NCT01313208|Secondary|Clinical Disease Activity Index (CDAI) Score at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest).~The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
2691106|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691107|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691108|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691109|NCT01313208|Secondary|Participant Assessment of Fatigue at Each Time Point|The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with '0' and 'no fatigue' on the left end of the line and '100' and 'extreme fatigue' on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691110|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."|||percent overall work impairment||Standard Error|Least Squares Mean
2691111|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient's assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||percent activity impairment||Standard Error|Least Squares Mean
2691112|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."|||percent impairment while working||Standard Error|Least Squares Mean
2691158|NCT01312961|Secondary|Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12|Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||number of inhalations/day||Standard Deviation|Mean
2691113|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."|||percent work time missed||Standard Error|Least Squares Mean
2691114|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691115|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691116|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691117|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691118|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691119|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691120|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691121|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2691122|NCT01313208|Secondary|C-reactive Protein Levels at Each Time Point|C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||mg/L||Standard Deviation|Mean
2691123|NCT01313208|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point|The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
2691124|NCT01313208|Secondary|Physician Global Assessment of Disease Activity at Each Time Point|"The global assessment of the participant's arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from No Activity at All (score = 0) to Worst Activity Imaginable (score = 10)."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
2691125|NCT01313208|Secondary|Patient's Global Assessment of Disease Activity at Each Time Point|"The participant's global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from No Activity at All (score = 0) to Worst Activity Imaginable (score = 10)."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
2691126|NCT01313208|Secondary|Patient Global Assessment of Joint Pain at Each Time Point|"The severity of the participant's joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing today, from '0' (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
2691127|NCT01313208|Secondary|Swollen 28-Joint Count (SJC28) at Each Time Point|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||swollen joints||Standard Deviation|Mean
2691128|NCT01313208|Secondary|Tender 28-Joint Count (TJC28) at Each Time Point|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||tender joints||Standard Deviation|Mean
2691129|NCT01313208|Secondary|Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:~28 tender joint counts,~28 swollen joint counts,~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and~C-reactive protein (CRP) in mg/dL.~The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
2691130|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point|The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2691131|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Remission at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:~28 tender joint counts,~28 swollen joint counts,~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and~C-reactive protein (CRP) in mg/dL.~The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2691133|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2691134|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Remission at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2691135|NCT01313208|Secondary|Percentage of Participants Achieving Count Remission at Each Time Point|"Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from no activity at all to worst activity imaginable)."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2691136|NCT01313208|Secondary|Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point|"The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do) and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity > 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3."|Baseline and Weeks 4, 12, and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2691137|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2691138|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2691139|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2691140|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at All Other Timepoints|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP)~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero to ten. A DAS28 above 5.1 indicates high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
2700875|NCT01238848|Secondary|Length of Oxygen Use|Length of oxygen use (days)|Participants will be followed for the duration of hospitalization, an expected average of 4 days||||days||Standard Deviation|Median
2691141|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-Reactive Protein (CRP) level~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analysis at each time point."|||percentage of participants|||Number
2691142|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at Week 12|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP)~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity."|Week 12|Primary analysis set; LOCF was used|||percentage of participants|||Number
2691143|NCT01313208|Primary|Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Week 12|Primary analysis set (all randomized participants); last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
2691144|NCT01313182|Secondary|Re-admission Rates in the Mupirocin and Povidone-iodine Groups.|Re-admission rates in the Mupirocin and Povidone-iodine Groups.|12 months|Data was not collected for this assessment.||||||
2691145|NCT01313182|Secondary|Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.|Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op.|Isolates collected and frozen immediately post-surgery.||||Participants|||Count of Participants
2691146|NCT01313182|Secondary|Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.|The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups.|Post-surgery|Data was not collected for this assessment.||||||
2691147|NCT01313182|Primary|Surgical Site Infections Occurring Within 12 Months of Surgical Procedure|Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.|12 months||||participants|||Number
2691148|NCT01313117|Secondary|Total Neuropathy Score (TNS)|The Total Neuropathy score (TNS) is a validated score that combines signs, symptoms, and very limited nerve conduction studies (NCS). It was designed to assess peripheral nerve function and has been used as an endpoint in clinical trials of toxic neuropathy. The TNS is a composite scale with a range of values from 0 (normal) to 28 (severely affected). It includes data from 7 different categories. Patients are asked to assess the severity of sensory symptoms on a scale of 0 (no symptoms) to 4 (symptoms above knees or elbows, or functionally disabling). Next, 4 examination categories are assessed. These include pin sensation, vibration sensation, deep tendon reflexes, and strength. Signs are scored from 0 to 4 depending on severity. The nerve conduction portion of the scale consists of measurements of a motor (peroneal) and sensory (sural) nerve. Motor and sensory responses are graded on a scale of 0 to 4 depending on the severity of an abnormality.|4 months|Failure to reach the MTD precluded our ability to perform any meaningful analysis of the TNS.||||||
2691149|NCT01313117|Secondary|Cumulative Rate of Adverse Events||4 months||||participants|||Number
2691150|NCT01313117|Secondary|Proportion of Patients Who Complete the Proposed Regimen of Daily ALA||4 months||||participants|||Number
2691151|NCT01313117|Primary|Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile|Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.|4 months|Although our dose finding analysis suggested a maximum tolerated dose of 500mg daily, it should be noted that we failed to fully complete the Continual Reassessment Method (CRM) dose finding portion of the study. As such, we can not make confident dose finding statements on the basis of this trial.|||mg|||Number
2691152|NCT01313078|Primary|Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|11 months, 25 days||||Participants|||Number
2691153|NCT01313078|Primary|6 Month Progression Free Survival|Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.|6 months||||Participants|||Number
2691154|NCT01313039|Secondary|In Vitro Tamoxifen Response in Tumors|To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.|2 years|||||||
2691155|NCT01313039|Secondary|Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer|To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.|2 years|||||||
2691156|NCT01313039|Secondary|Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer|To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.|2 Years|||||||
2691157|NCT01313039|Primary|Increase of ER Protein Expression in ER-Negative/Low Breast Cancer|"To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the ER response rate by both standard immunohistochemistry and Allred Score."|2 years|Only 1 subject had evaluable study data|||participants|||Number
2691160|NCT01312961|Secondary|Change From Baseline in Evening Asthma Symptom Scores to Week 12|PM (post meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2691161|NCT01312961|Secondary|Change From Baseline in Morning Asthma Symptom Scores to Week 12|AM (ante meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2691162|NCT01312961|Secondary|Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12|The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2691163|NCT01312961|Secondary|Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12|ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2691164|NCT01312961|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) to Week 12|The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.|Baseline, Week 12|mITT population. Number analyzed = participants with at least one post-baseline assessment for each category.|||liters/minute||Standard Deviation|Mean
2691165|NCT01312961|Secondary|Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||Liters||Standard Deviation|Mean
2691166|NCT01312961|Secondary|Percentage of Participants With Composite Asthma Events|Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.|Baseline up to Week 12|mITT population.|||percentage of participants|||Number
2691167|NCT01312961|Secondary|Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12|The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.|Baseline up to Week 12|mITT population.|||Probability of asthma exacerbation||95% Confidence Interval|Number
2691168|NCT01312961|Primary|Percentage of Participants With Asthma Exacerbation|An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.|Baseline up to Week 12|Modified intent-to-treat (mITT) population that included all randomized participants who received at least one dose of study drug. Participants were analysed in the treatment group to which they were randomized.|||percentage of participants|||Number
2691169|NCT01312948|Secondary|Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask|Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the patients usual mask|>4 hours monitored sleep study|Analysis was as per protocol|||apnea hypopnoea index||Standard Deviation|Mean
2691170|NCT01312948|Primary|Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask|"Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask.~Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability."|8 nights use|Analysis was as per protocol|||units on a scale||Standard Deviation|Mean
2692690|NCT01300572|Secondary|Disease-free Survival|Number of study participants who are alive and remains in complete remission after transplant.|100 days after transplant|Study participants who completed study regimen and in CR after transplant.|||participants|||Number
2691171|NCT01312909|Other Pre-specified|Change From Baseline in Pulse Rate at Week 12|Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.|Baseline, Week 12|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number of participants analyzed’ signifies participants evaluable for this outcome measure.|||beats per minute (bpm)||Full Range|Median
2691172|NCT01312909|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Week 12|Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.|Baseline, Week 12|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number of participants analyzed’ signifies participants evaluable for this outcome measure.|||millimeters of mercury (mmHg)||Full Range|Median
2691173|NCT01312909|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.|Baseline up to Week 12|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number of Participants Analyzed= participants evaluable for this outcome measure.|||Participants|||Count of Participants
2691174|NCT01312909|Other Pre-specified|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points|Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number analyzed’ signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2691175|NCT01312909|Other Pre-specified|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points|The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number analyzed’ signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2691176|NCT01312909|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of Yes on actual attempt);preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior,aborted attempt or interrupted attempt),suicidal ideation (Yes on wish to be dead,non-specific active suicidal thoughts,active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent (Yes on Has participant engaged in non-suicidal self-injurious behavior).Here,number of participants with positive response (response of yes) to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported."|Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
2691177|NCT01312909|Other Pre-specified|Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.|First dose up to last dose (up-to Week 12) plus 30 days|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
2691190|NCT01312844|Secondary|Number of ECT Treatments Withheld Due to Cognitive Impairment|The number of ECT treatments withheld during the course of the study due to cognitive impairment. In these cases, the participant would still be enrolled in the study but have a reduced # of ECTs. This outcome measure does not include patients who withdrew from the study.|Duration of ECT treatment (usually 2 weeks)||||ECT Treatments withheld||Standard Deviation|Mean
2691204|NCT01312779|Other Pre-specified|Subject's Average Hematocrit Percentage|Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).|Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||percentage of red blood cells||Standard Deviation|Mean
2691178|NCT01312909|Other Pre-specified|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.|First dose up to last dose (up-to Week 12) plus 30 days|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
2691179|NCT01312909|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.|First dose up to last dose (up-to Week 12) plus 30 days|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
2691180|NCT01312909|Secondary|Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52|The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.|Week 9 through Week 24; Week 9 through Week 52|The full analysis set included all randomized participants.|||percentage of participants|||Number
2691181|NCT01312909|Secondary|Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52|The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.|Baseline, Weeks 12, 24, and 52|The full analysis set included all randomized participants. The longitudinal model included all participants regardless of observed visits.|||cigarettes smoked per day||Standard Error|Least Squares Mean
2691182|NCT01312909|Secondary|Daily Number of Cigarettes Smoked at Baseline|The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.|Baseline|The full analysis set included all randomized participants.|||cigarettes smoked per day||Standard Error|Mean
2691183|NCT01312909|Secondary|Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52|The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.|Weeks 12, 24 and 52|The full analysis set included all randomized participants.|||percentage of participants|||Number
2691184|NCT01312909|Primary|4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12|The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).|Week 9 through Week 12|The full analysis set included all randomized participants.|||percentage of participants|||Number
2691185|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Energy Needed)|Mean energy needed to induce the seizure for each participant at each ECT administration they received. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||joules||Standard Deviation|Mean
2691186|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Seizure Duration)|Mean duration in seconds of the seizure induced by ECT for each participant at each ECT administration they received.The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||seconds||Standard Deviation|Mean
2691187|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Heart Rate)|Heart rate was taken immediately post ECT administration at each ECT visit. We averaged heart rate for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||Beats per minute||Standard Deviation|Mean
2691188|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Blood Pressure)|Blood pressure was taken immediately post ECT administration at each ECT visit. We averaged Blood pressure for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||mmHg||Standard Deviation|Mean
2691189|NCT01312844|Secondary|The Mean Number of Moderate to Severe Side Effects|The mean number of adverse events classified as moderate to severe.|Duration of ECT treatment (usually 2 weeks)||||number of side effects||Standard Deviation|Mean
2691225|NCT01312766|Secondary|Implantation Rate|defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;|10-11 weeks after embryo transfer||||percentage of embryos transferred||Standard Deviation|Mean
2691191|NCT01312844|Primary|Number of ECT Treatments Received to Achieve Response/Remission|The number of ECT treatments needed to achieve response (defined as a HAM D score less than half of baseline) and remission (defined as a HAM D score of less than 8). If patients HAM D score rose above these markers at any point in the study, they were not considered as responding or remitting.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression.|Duration of ECTtreatment (usually 2 weeks)|Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response and remission.|||# of ECT administrations||Standard Deviation|Mean
2691192|NCT01312844|Primary|Time to Response for Patients Receiving ECT|The number of days between baseline HAM D score and HAM D score showing response (defined as a HAM D score less than half of baseline). If patients HAM D score rose above this marker at any point in the study, they were not considered as responding.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. .|Duration of ECT treatment (usually 2 weeks)|Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response|||days||Standard Deviation|Mean
2691193|NCT01312844|Primary|Change in Ham D 17 Scores|Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.|At the time of ECT completion (about 2 weeks)||||units on a scale||Standard Deviation|Mean
2691194|NCT01312818|Secondary|Number of Subjects With Activated Caspases and Other Regulators of Apoptosis|Activation of caspases and other regulators of apoptosis in treated blast cells will be determined by Western analysis (correlative lab analysis).|From Day 1 to 30 Days After Last Dose|The trial was terminated early with only 2 patients so caspase samples were not sent for analysis.||||||
2691195|NCT01312818|Secondary|Number of Subjects Experiencing Drug Related Adverse Events|To characterize the toxicities of bortezomib, vorinostat and dexamethasone when used in combination. Toxicity will be graded using the NCI's Common Terminology Criteria for Adverse Events (CTCAE 4.0).|Day 1 of Treatment to 30 Days Post Treatment||||participants|||Number
2691196|NCT01312818|Primary|Number of Subjects Who Achieved Complete Remission of Their Disease|Complete Remission (CR): A CR requires that the following be recorded concurrently: an absolute neutrophil count (segs and bands) > 1000/μL, no circulating blasts, platelets > 100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and < 5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent. If patients continue on with treatment, there can be no evidence of recurrence of ALL for at least 4 weeks.|Day 30||||participants|||Number
2691197|NCT01312805|Primary|Diagnosis Rate of Asthma||one year|We excluded those participants who had a previous diagnosis of asthma in the 14 months before the start of the study. This left the numbers seen above.|||Participants|||Count of Participants
2691198|NCT01312779|Other Pre-specified|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|6 Months and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||units on a scale||Standard Deviation|Mean
2691199|NCT01312779|Other Pre-specified|Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||Participants|||Count of Participants
2691200|NCT01312779|Other Pre-specified|Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post‐Implant.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath)."|Baseline and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||Participants|||Count of Participants
2691201|NCT01312779|Other Pre-specified|Subject's Average Platelet Count|Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.|Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||10^3 platelets per microliter||Standard Deviation|Mean
2691202|NCT01312779|Other Pre-specified|Subject's Average Hemoglobin Count|Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.|Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||g/dl||Standard Deviation|Mean
2691203|NCT01312779|Other Pre-specified|Subject's Average Plasma Free Hemoglobin|Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).|Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||mg/dl||Standard Deviation|Mean
2691226|NCT01312766|Secondary|17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;||up to 23 days after treatment start||||pg/ml||Standard Deviation|Mean
2691206|NCT01312779|Other Pre-specified|Subject's Average Red Blood Cells Count|Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.|Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
2691207|NCT01312779|Other Pre-specified|Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant.|Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||Participants|||Count of Participants
2691208|NCT01312779|Other Pre-specified|Subject's Average Left Ventricular Mass Regression|Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.|Pre-procedure and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||grams||Standard Deviation|Mean
2691209|NCT01312779|Other Pre-specified|Subject's Average Cardiac Index|Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.|Pre-procedure and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||L/min/m2||Standard Deviation|Mean
2691210|NCT01312779|Other Pre-specified|Subject's Average Cardiac Output|The amount of blood the heart pumps through the circulatory system in a minute.|Pre-procedure and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||Liters/minute||Standard Deviation|Mean
2691211|NCT01312779|Other Pre-specified|Subject's Average Performance Index Measurement|Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.|Pre-procedure and 1 Year post-Implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||cm^2/cm^2||Standard Deviation|Mean
2691212|NCT01312779|Other Pre-specified|Subject's Average Effective Orifice Area Index (EOAI) Measurement|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|Pre-procedure and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||cm^2/m^2||Standard Deviation|Mean
2691213|NCT01312779|Other Pre-specified|Subject's Average Peak Gradient Measurement|Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|Pre-procedure and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||mmHg||Standard Deviation|Mean
2691214|NCT01312779|Other Pre-specified|Subject's Average Mean Gradient Measurement|Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Pre-procedure and 1 Year post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||mmHg||Standard Deviation|Mean
2691215|NCT01312779|Primary|Subject's Average Effective Orifice Area (EOA) Measurement|Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.|Pre-procedure and 1 Year post-Implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||Centimeters Squared||Standard Deviation|Mean
2691216|NCT01312779|Primary|Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days|Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.|>30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||percentage of subjects|||Number
2691217|NCT01312779|Primary|Percent of Late Adverse Events|Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occurring >= 31 days and up through 5 years post-implant|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||percentage of events/late patient years|||Number
2691218|NCT01312779|Primary|Percent of Early Adverse Events Divided|Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.|Events occuring within 30 days of procedure|The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.|||percentage of subjects|||Number
2691219|NCT01312766|Secondary|Live Birth Rate||9 months after treatment||||percentage of participants|||Number
2691220|NCT01312766|Secondary|Number of Cleaved Embryos||two days after insemination||||embryos||Standard Deviation|Mean
2691221|NCT01312766|Secondary|Total Number of Inseminated Oocytes (IVF and ICSI)|number of oocytes that were inseminated via IVF or injected via ICSI technique.|on the day of oocyte retrieval||||oocytes||Standard Deviation|Mean
2691222|NCT01312766|Secondary|Ratio Mature/Total Number of Oocytes Retrieved.|Percentage of retrieved oocytes considered to be mature.|at the end of the stimulation.||||percentage of total oocytes retrieved|||Number
2691223|NCT01312766|Secondary|Number of Mature (Grade III Metaphase II) Oocytes Retrieved.||at the end of the stimulation.||||oocytes||Standard Deviation|Mean
2691224|NCT01312766|Secondary|Clinical Pregnancy Rate,|defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;|10 - 11 weeks after embryo transfer||||percentage of participants|||Number
2691229|NCT01312766|Secondary|Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)|Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.|up to 28 days after treatment start|The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.|||percentage of participants|||Number
2691230|NCT01312766|Secondary|Mean hMG Dose (Total);||up to 22 days after treatment start||||Internationa Units (IU)||Standard Deviation|Mean
2691231|NCT01312766|Primary|Total Number of Oocytes Retrieved||up to 24 days after treatment start||||number of oocytes||Standard Deviation|Mean
2691232|NCT01312675|Primary|Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)|"The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8.~The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function).~Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition."|Baseline through Day 8|Intent to Treat (ITT)|||scores on a scale||Standard Deviation|Mean
2691233|NCT01312519|Secondary|Time Necessary to Perform the Bone Marrow Procedure|The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.|Day 1 needle insertion through needle removal|Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.|||seconds||Standard Deviation|Mean
2691234|NCT01312519|Primary|Subject Reported Level of Pain During Procedure|Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.|Day 1 during the needle insertion|as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.|||units on a scale||Standard Deviation|Mean
2691235|NCT01312467|Secondary|Safety and Tolerability of Metformin Hydrochloride Treatment|All participants will be evaluable for toxicity from the time of their first dose of metformin. Since toxicities in this study are measured as categorical data, primary analysis shall be by tests of binomial proportions (e.g., Mantel-Haenszel chi-squared statistic). This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting.|Up to 16 weeks|45 participants were enrolled and 45 participants were analyzed for toxicity.|||adverse events|||Number
2691236|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Serum (Fasting and 2 Hour Postprandial Insulin and Glucose, Fasting IGF-1, IGFBP-1, IGFBP-3, Leptin, Adiponectin and Metformin Levels)|Data not collected.|Up to 16 weeks|Funding was not secured to complete the secondary and tertiary endpoints.||||||
2691237|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Colorectal Mucosa Proliferation (Ki-67, Phosphorylated IGF-1 Receptor, Phosphorylated Insulin Receptor, Phosphorylated AKT, Phosphorylated mTOR, and Phosphorylated AMP Kinase)|Data not collected.|Up to 16 weeks|Funding was not secured to complete the secondary and tertiary endpoints.||||||
2691238|NCT01312467|Primary|Change in Activated S6serine235 (i.e., the Ratio of pS6serine235/S6serine235)|Tissue S6Ser235 immunostaining was analyzed by the study pathologist using Histo Score (HScore) analysis at baseline and post- metformin (Week 12). The Hscore is determined by estimation of the percentage of cells positively stained with mild, moderate, or strong staining intensity. The final score is determined by weighted estimate, as follows: Hscore = (# cell stained with High intensity/total # cells)x3 + (# cells stained with median intensity/total # cells)x2 + (# cells stained with low intensity/total # cells)x1. Mean and standard deviation of the change in the histo score (H score) of pS6serine235 from baseline were calcuated.|From baseline to 12 weeks|The analysis is based on 32 participants who have evaluable data.|||weighted ratio of staining cells||Standard Deviation|Mean
2691239|NCT01312428|Secondary|To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up|The study was terminated early, therefore, primary or secondary measures were not assessed.||||||
2691240|NCT01312428|Primary|To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up|The study was terminated early, therefore, primary or secondary measures were not assessed.||||||
2691241|NCT01312272|Secondary|Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score|"This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups.~The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112).~Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5)."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||change in units on scale||Standard Deviation|Mean
2691256|NCT01311895|Secondary|Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes||60 minutes|"The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"|||Participants|||Count of Participants
2691242|NCT01312272|Secondary|Facial Affect Recognition (Low Level Social Cognition)|Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
2691243|NCT01312272|Secondary|Social Perception Assessment (Low Level Social Cognition)|We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
2691244|NCT01312272|Secondary|Empathy|Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
2691245|NCT01312272|Secondary|Theory of Mind Assessment (High Level Social Cognition)|The Awareness of Social Inference Test (TASIT Part III: Social Inference - Enriched) will be administered to assess theory of mind.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
2691246|NCT01312272|Primary|Social Cognition Composite Measure|"Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two high-level measures and two low-level measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
2691247|NCT01312233|Secondary|Patient Satisfaction With Care|Percent of participants reporting levels of satisfaction for the information received regarding the cause of low back pain [LBP] (A), prognosis of LBP (B) and activities that hasten recovery (C), concern of MDs and Doctor of Chiropractic (DCs) during treatments (D), the quality of the treatment recommendations(E) and the overall care for LBP (F)|3 months|9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.|||Participants|||Count of Participants
2691248|NCT01312233|Secondary|Change From Baseline in Bothersomeness of Low Back Pain Symptoms|Adjusted mean changes in patient-reported LBP bothersomeness on a 5 point scale index (1, not at all bothered; 5, extremely bothered) from baseline to week 12 were assessed.|Baseline to 3 months|9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.|||units on a scale||95% Confidence Interval|Mean
2691249|NCT01312233|Secondary|Veterans-RAND 36-item Short-Form Health Survey (VR-36)|Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome.|Baseline and 3 months|9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.|||units on a scale (0-100)||Standard Deviation|Mean
2691250|NCT01312233|Primary|Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ)|Adjusted mean changes in patient-rated disability from baseline to week 12 were assessed using the 24-item RMDQ where 0 indicated no disability and 24 indicated severe disability.|Baseline and 3 months|9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.|||units on a scale||95% Confidence Interval|Mean
2691251|NCT01312233|Primary|Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS)|Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible)|Baseline and 3 months|9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up.|||units on a scale||95% Confidence Interval|Mean
2691252|NCT01312181|Primary|Total Dollar Value of Primary Drug Used in the Prior 30 Days|One primary study outcome was quantity of drug used in the prior 30 days, represented by the total dollar amount of primary drug used (QuantU) in the prior 30 days, as derived from the Time Line Follow Back (TLFB).|Assessed at end of treatment (60 days)||||Dollars||Standard Deviation|Mean
2691253|NCT01312181|Primary|Total Number of Days of Primary Drug Used in the Prior 30 Days|One primary study outcome was frequency of drug use, represented by the total number of days of primary drug used in the prior 30 days (NumDU) as derived from the Time Line Follow Back (TLFB).|Assessed at end of treatment (60 days)||||Days||Standard Deviation|Mean
2691254|NCT01312129|Primary|% BOLD Response Increase Above Baseline|Test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). BOLD response refers to brain activation in response to the presence of oxygen in a particular part of the brain. To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment. During the fMRI scan session, participants will be presented with the alcohol cue task. We will compare the difference in BOLD response during the presence of alcohol vs. a novel substance during the alcohol cue task. Outcome data collected during the alcohol cue task will provide us with BOLD response data for each intervention period. We will analyze the outcome data using FSL (Oxford Centre for Functional MRI of the Brain (FMRIB) Software - a collection of functional and structural brain image analysis tools).|Over two weeks||||% BOLD Response increase above baseline||Standard Deviation|Mean
2691255|NCT01312038|Primary|Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)|The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow|After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment|ears pre-treatment/ears post-treatment|||ratio|Participants|Standard Deviation|Mean
2691257|NCT01311895|Secondary|Mean Change in Pain Intensity From Baseline to 60 Minutes|"Pain intensity is measured in numerical rating scale (NRS) units from 0 (no pain) to 10 (worst pain imaginable). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department."|60 minutes|"The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"|||units on a scale||Standard Deviation|Mean
2691258|NCT01311895|Primary|Number of Patients With Satisfactory Pain Management at 60 Minutes|The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.|60 minutes|"The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"|||Participants|||Count of Participants
2691259|NCT01311687|Secondary|Time to First Worsening of Quality of Life (QOL) Domains|Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following: For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM. For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM. See previous outcome measures for definitions of each scale.|Assessed on Day 1 of the first 6 treatment cycles.|PRO population|||days||95% Confidence Interval|Median
2691260|NCT01311687|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score|"EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals perfect health, a score of 0 equals death and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL"|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point.|||units on a scale||Standard Deviation|Mean
2691261|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain|The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom).|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point.|||units on a scale||Standard Deviation|Mean
2691262|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms|The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms.|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point.|||units on a scale||Standard Deviation|Mean
2691263|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom).|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point|||units on a scale||Standard Deviation|Mean
2691272|NCT01311687|Secondary|Duration of Response|Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population|||weeks||95% Confidence Interval|Median
2692935|NCT01298778|Secondary|Incidence of Persistent Pain|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.|2 months||||percentage of participants|||Number
2691264|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point.|||units on a scale||Standard Deviation|Mean
2691265|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point.|||units on a scale||Standard Deviation|Mean
2691266|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|PRO population with available data at Baseline and each time point.|||units on a scale||Standard Deviation|Mean
2691267|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point are included.|||units on a scale||Standard Deviation|Mean
2691268|NCT01311687|Secondary|Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score. The categories of the ECOG Performance Status Scale are as follows: -0: Fully active, able to carry on all pre-disease performance without restriction; -1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work; -2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Patients with a score of 3, 4 or 5 were excluded from participating in the study.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in ECOG performance status during the study|||weeks||Full Range|Median
2691269|NCT01311687|Secondary|Time to Improvement in Renal Function|Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function. Renal Function was categorized as (from best to worst): - Normal: creatinine clearance ≥80 mL/min; - Grade 1: creatinine clearance ≥60 to <80 mL/min; - Grade 2 : creatinine clearance ≥45 to < 60 mL/min. Participants with creatinine clearance < 45 mL/min at baseline were excluded from the study.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in renal function|||weeks||Full Range|Median
2691270|NCT01311687|Secondary|Time to Improvement in Bone Pain|"Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category. Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, Have you had bone aches or pain?: 1) Not at all, 2) A little, 3) Quite a bit, or 4) Very much."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in bone pain|||weeks||Full Range|Median
2691271|NCT01311687|Secondary|Time to the First Hemoglobin Improvement|Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are: 1) Normal; 2) CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL; 3) CTCAE Grade 2: < 10.0 to <8.0 g/dL. Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in hemoglobin during the study|||weeks||Full Range|Median
2691273|NCT01311687|Secondary|Time to Response|Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population|||weeks||Full Range|Median
2691274|NCT01311687|Secondary|Time to Progression|Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population|||weeks||95% Confidence Interval|Median
2691275|NCT01311687|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria|Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee: CR requires all of the following: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population|||percentage of participants|||Number
2691276|NCT01311687|Secondary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria|Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee: SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population|||percentage of participants|||Number
2691277|NCT01311687|Secondary|Overall Survival Based on the Final Dataset|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 29 August 2017. Maximum time on follow-up for survival was 324 weeks.|Intent-to-treat|||weeks||95% Confidence Interval|Median
2691278|NCT01311687|Secondary|Overall Survival With a Later Cut-off Date|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.|Intent-to-treat|||weeks||95% Confidence Interval|Median
2691279|NCT01311687|Secondary|Overall Survival - Primary Analysis|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks.|Intent-to-treat|||weeks||95% Confidence Interval|Median
2691280|NCT01311687|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.|From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.|Safety population (all randomized participants who received at least one dose of study drug (either pomalidomide or dexamethasone)).|||Participants|||Count of Participants
2691281|NCT01311687|Primary|Progression-free Survival (PFS) With a Later Cut-off Date|Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.|From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks.|Intent-to-treat population|||weeks||95% Confidence Interval|Median
2691282|NCT01311687|Primary|Progression-free Survival (PFS) - Primary Analysis|Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.|From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.|Intent-to-treat population|||weeks||95% Confidence Interval|Median
2691283|NCT01311661|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event reporting includes 12 days into the subsequent washout or post-treatment period.|3 weeks + 12 days|Treated set|||Participants|||Number
2691284|NCT01311661|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 3-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|3 weeks|FAS|||Units on a scale||Standard Error|Mean
2691285|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS|||Number of patients|||Number
2691286|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment .|0-3 weeks|FAS|||Number of patients|||Number
2691287|NCT01311661|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS|||Number of patients|||Number
2691288|NCT01311661|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM3 device.|0-3 weeks|FAS|||Percentage of asthma symptom free days||Standard Error|Mean
2691289|NCT01311661|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM3 device (overall mean number obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Puffs||Standard Error|Mean
2691290|NCT01311661|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||mL||Standard Error|Mean
2691291|NCT01311661|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||mL||Standard Error|Mean
2691292|NCT01311661|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Percentage||Standard Error|Mean
2691293|NCT01311661|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Liter/min||Standard Error|Mean
2691294|NCT01311661|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Liter/min||Standard Error|Mean
2691295|NCT01311661|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 PEF values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
2691296|NCT01311661|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
2691297|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
2691298|NCT01311661|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
2691299|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
2691300|NCT01311661|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FVC values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691301|NCT01311661|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post-dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691302|NCT01311661|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691303|NCT01311661|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691304|NCT01311661|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691305|NCT01311661|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691306|NCT01311661|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2700982|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2691307|NCT01311661|Secondary|FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691308|NCT01311661|Secondary|FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
2691309|NCT01311661|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.|||Liter||Standard Error|Mean
2691310|NCT01311557|Secondary|Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2691311|NCT01311557|Secondary|Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2691312|NCT01311557|Secondary|Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine|Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.|Day 0 (pre-vaccination) and 30 days post-vaccination|Seroprotection rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2691313|NCT01311557|Primary|Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.|30 days post-vaccination|Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
2691314|NCT01311557|Primary|Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.|30 days post-vaccination|Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
2691315|NCT01311557|Primary|Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2691316|NCT01311505|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.|||participants|||Number
2691317|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Respiratory Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since respiratory rate remained within normal limits throughout the study and there were no significant deviations from baseline.|||respirations/minute||Standard Deviation|Mean
2691338|NCT01311024|Secondary|Carriage Due to Haemophilus Influenzae|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age|||||||
2691318|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Oral Temperature|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since oral temperature remained within normal limits throughout the study and there were no significant deviations from baseline.|||Degrees Celsius||Standard Deviation|Mean
2691319|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Pulse Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since pulse rate remained within normal limits throughout the study and there were no significant deviations from baseline.|||beats per minute||Standard Deviation|Mean
2691320|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Supine Blood Pressure (BP)|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since supine systolic and diastolic BP remained within normal limits throughout the study and there were no significant deviations from baseline.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2691321|NCT01311505|Other Pre-specified|Number of Participants With Abnormal Safety Laboratory Test Values|Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.|Screening and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.|||participants|||Number
2691322|NCT01311505|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Percent AUC||Geometric Coefficient of Variation|Geometric Mean
2691323|NCT01311505|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hrs||Standard Deviation|Mean
2691324|NCT01311505|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691325|NCT01311505|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hrs||Full Range|Median
2691326|NCT01311505|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2691327|NCT01311505|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||microgram*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2691328|NCT01311362|Primary|Cmax of Ambrisentan||after first dose, at steady-state and during St John's wort||||ng/ml||95% Confidence Interval|Geometric Mean
2691329|NCT01311362|Primary|AUC of Ambrisentan||after first dose, at steady-state, during St John's wort||||h*ng/ml||95% Confidence Interval|Geometric Mean
2691330|NCT01311102|Primary|Pain During IUD Placement|"IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Immediately after IUD placement||||units on a scale of 0-9||Standard Deviation|Mean
2691331|NCT01311102|Primary|Pain Measurement During Liquid Infusion/Sounding|"After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Recorded at the end of the infusion||||units on a scale of 0-9||Standard Deviation|Mean
2691332|NCT01311102|Primary|Pain During Tenaculum Placement|"Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being no pain and 9 being worst pain in life. Taken to adjust for different pain thresholds among subjects"|Immediately following tenaculum placement||||units on a scale of 0-9||Standard Deviation|Mean
2691333|NCT01311102|Primary|Pain Scores During Overall IUD Placement|"Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being no pain and 9 being worst pain in life."|Before patient left the examination room at conclusion of procedure||||units on a scale of 0-9||Standard Deviation|Mean
2691334|NCT01311024|Secondary|Outpatient Antibiotic Treatment|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
2691335|NCT01311024|Secondary|Tympanostomy Tube Surgery|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
2691336|NCT01311024|Secondary|Hospital-diagnosed Pneumonia|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
2691337|NCT01311024|Secondary|Invasive Pneumococcal Disease|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
2691340|NCT01311024|Primary|Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules|Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age||||percentage of subjects|||Number
2691341|NCT01310868|Secondary|Survival at 24 Months||from the date of surgery to 24 months|Patients receiving 5-ala and carmustine wafers during surgical resection for glioblastoma multiforme that was confirmed peri/post-operatively|||months||95% Confidence Interval|Median
2691342|NCT01310868|Secondary|Time to Clinical Progression||from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported|Patients receiving 5-ala and carmustine wafers during surgical resection for glioblastoma multiforme that was confirmed peri/post-operatively|||months||95% Confidence Interval|Median
2691343|NCT01310868|Primary|Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide|"Procedure compliance: Proportion of 5-ALA resected patients who received Carmustine wafer implants (e.g to take into account rates of patients who did not receive Carmustine wafer implants due to 1) ventricular breach, 2) inaccurate peri-operative diagnosis, 3) intra-operative surgical decision)~Post-operative complication rate: Proportion of patients with a new post-operative deficit or surgical complication (wound infection, CSF leakage, intracranial hypertension)~No. of patients with chemoRT delay (i.e number who do not begin chemoRT 6 weeks after surgery) due to surgical complications*~No. of patients failing to start chemoRT due to surgical complications rather than tumour progression~No. of patients failing to complete chemoRT without interruption (RT with concomitant chemotherapy, and RT with concomitant plus adjuvant chemotherapy)~Proportion of patients with a lower WHO performance status after surgery with Carmustine wafers (at first post-operative clinic visit)"|Date of surgery to end of temozolomide and radiotherapy treatment (up to 34 weeks)|of 72 patients recruited, 62 received 5-ALA and carmustine wafers. Of these 62 patients, 59 were found to be eligible and included in the final analysis|||Participants|||Count of Participants
2691344|NCT01310855|Secondary|Safety and Tolerability||from date of randomisation to death|||||||
2691345|NCT01310855|Secondary|Time to Deterioration of Neurological Status||from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.|||||||
2691346|NCT01310855|Secondary|Steroid Use||from randomization to first increase in dexamethasone dose|||||||
2691347|NCT01310855|Secondary|Progression-free Survival Rate at 6 Months||from the date of randomisation to 6 months|||||||
2691348|NCT01310855|Secondary|Radiographic Response Rate||from baseline scan to six week and 12 week scans|||||||
2691349|NCT01310855|Secondary|Overall Survival||from date of randomization to date of Death due to any cause.|||||||
2691350|NCT01310855|Primary|Progression-free Survival|"Progression free survival (PFS) defined as the time from the date of randomisation to the date of first progression or death due to any cause, whichever one comes first.~The progression definition will be based on modified RANO criteria (Wen 2010), such that progression will be defined as the earliest time that at least one of the following occurs:~Clinical deterioration~Failure to return for evaluation as a result of death or deteriorating condition~Or, by retrospective radiographic central review:~Any new lesion~Increase in ≥25% of sum of the products of perpendicular diameters of enhancing lesions compared with baseline scan, on stable or increasing doses of steroids (dexamethasone) compared to baseline (T1 post-contrast scan)~Clear progression of non-measureable disease~Significant increase in T2/FLAIR non-enhancing lesion - on stable or increasing steroids (dexamethasone) compared with baseline or best response not caused by co-morbid events."|from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken)||||months||90% Confidence Interval|Median
2691351|NCT01310803|Secondary|To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder|The occurrence of serious adverse events (SAEs), occurrence of local adverse reactions (LARs), results of vital signs, physical exams and laboratory test, and study discontinuation due to inability to complete valrubicin instillations|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.||||||
2691352|NCT01310803|Primary|To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.|time interval from randomization to an event. An event is defined as tumor recurrence (any stage or grade), tumor progression to muscle-invasive bladder cancer (MIBC), metastatic bladder cancer or death from any cause, whichever occurs first. Tumor recurrence or progression must be documented by biopsy/transurethral resection of bladder tumor (TURBT).|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.||||||
2691353|NCT01310777|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|The intent-to-treat (ITT) analysis set included all subjects who received study drug and completed at least 1 scheduled on-therapy study visit.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2691354|NCT01310699|Secondary|Percentage of Nonpolypoid (Flat) Missed Lesions|Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)|Adenoma by shape (i.e. Flat)|||percentage of adenomas|||Number
2691355|NCT01310699|Secondary|Percentage of Missed Lesions on Index Colonoscopy.|Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)||||percentage of adenomas|||Number
2691356|NCT01310699|Primary|Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm|Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)||||Participants|||Count of Participants
2691357|NCT01310582|Secondary|Time to Discharge From PACU||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU||||Minutes||Standard Deviation|Mean
2691358|NCT01310582|Primary|Time to Opening of Eyes||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery||||seconds||Standard Deviation|Mean
2691359|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691360|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available."|During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691361|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination."|During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691362|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination."|During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691363|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691364|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination."|During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691365|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination."|During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2700983|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2691366|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination."|During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691367|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691368|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691369|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691370|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691371|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691372|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691373|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691374|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691375|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691376|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691377|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject."|From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691378|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject."|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691379|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691380|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691381|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|"Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. Any was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C."|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691382|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|"Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. Any was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C."|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691383|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|"Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. Any was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C."|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691384|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|"Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. Any was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C."|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691385|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|"Solicited local symptoms assessed were pain and swelling. Any was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
2691386|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, solely on subjects with results available/accessible.|||Subject|||Number
2691387|NCT01310413|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.|At Day 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.|||Subject|||Number
2691388|NCT01310413|Secondary|Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.||At Days 0 and 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.|||Subject|||Number
2693463|NCT01294748|Primary|In-Stent Late Lumen Loss|Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up|9 months||||mm||Standard Deviation|Mean
2691389|NCT01310413|Secondary|Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.|At Days 0, 42, 182 and 385|Analysis was done on the Day 42, 182 and 385 ATP cohorts for immunogenicity, that is, 50 percent of the evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0, 42, 182 and 385 time points.|||Titer||95% Confidence Interval|Geometric Mean
2691390|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 385.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available|||Fold increase||95% Confidence Interval|Geometric Mean
2691391|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 385|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available|||Subjects|||Number
2691392|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.~As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Subjects|||Number
2691393|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Titer||95% Confidence Interval|Geometric Mean
2691394|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available|||Ratio||95% Confidence Interval|Geometric Mean
2691395|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available|||Subject|||Number
2691403|NCT01310413|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Subject|||Number
2700984|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2691396|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Titer||95% Confidence Interval|Geometric Mean
2691397|NCT01310413|Secondary|Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.~As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 182|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Subject|||Number
2691398|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385."|At Day 0 and Day 182.|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Titre||95% Confidence Interval|Geometric Mean
2691399|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Days 21 and 42|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Ratio||95% Confidence Interval|Geometric Mean
2691400|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|"A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.~As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Days 21 and 42|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Subject|||Number
2691401|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Subject|||Number
2691402|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Titer||95% Confidence Interval|Geometric Mean
2693546|NCT01294397|Secondary|Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations||Baseline (Day 8) and Days 22, 29, 85, and 176|Participants with available data at baseline (19) and each time point (indicated by n)|||percent change||Inter-Quartile Range|Median
2691404|NCT01310400|Secondary|Safety: Incidence of Solicited and Unsolicited Adverse Events|Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.|Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end||||percentage of subjects with AEs|||Number
2691405|NCT01310400|Secondary|Seroprotection|Seroprotection rate, defined as a post-vaccination HI titer of 1:40.|3 weeks after the 2nd vaccination||||percentage seroprotected subjects||95% Confidence Interval|Number
2691406|NCT01310400|Secondary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value|3 weeks after the 2nd vaccination||||Fold (ratio)|||Number
2691407|NCT01310400|Primary|Immunogenicity, Assessed by the Haemagglutination (HI) Test|Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.|3 weeks after the 2nd vaccination|According-to-protocol population: subjects who received both doses of influenza vaccine, with available pre- and post-vaccination titers and without major protocol violations|||percentage of participants||95% Confidence Interval|Number
2691408|NCT01310179|Secondary|Treatment Outcome and Percent Change in Tumor Volume|Measurement of tumor response to study drug, as measured by the percentage of change in tumor volume as measured by a physicial measurement using a ruler|Entry through Study Day 56||||participants|||Number
2691409|NCT01310179|Primary|Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|Entry through Study Day 56||||participants|||Number
2691410|NCT01310127|Primary|Macular Volume|Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength|6 weeks||||mm cubed||Standard Deviation|Mean
2691411|NCT01310127|Primary|OCT Retinal Thickness|Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.|Week 6||||micrometers cubed||Standard Deviation|Mean
2691412|NCT01310127|Primary|Summed Ocular Inflammation Score (SOIS)|An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).|Week 6||||units on a scale||Standard Deviation|Mean
2691413|NCT01310127|Primary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities|ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.|Week 6||||letters||Standard Deviation|Mean
2691414|NCT01310075|Primary|Number of Participants With Complications After Tissue Expander Replacement With Implant||through study completion, an average of 1 year|Of the 90 randomized participants, 66 (74%) were evaluable for the primary measure|||participants|||Number
2691415|NCT01310036|Secondary|Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)|This outcome measure was not assessed.|Approximately 68 months|Data were not collected.||||||
2691416|NCT01310036|Secondary|Number of Participants With Adverse Events|An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Approximately 68 months|The safety population included all participants who received at least one dose study medication and had at least one post baseline safety assessment.|||participants|||Number
2691417|NCT01310036|Secondary|Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R|OS was defined as the time from baseline to the date of death from any cause.|Approximately 68 months|The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.|||months||95% Confidence Interval|Median
2691418|NCT01310036|Secondary|Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)|PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.|Approximately 68 months|The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.|||months||95% Confidence Interval|Median
2691435|NCT01309893|Secondary|Slit Lamp Findings ≥ Grade 2|Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.|1 week|All dispensed eyes|||eyes|Participants||Number
2691419|NCT01310036|Secondary|Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R|DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.|Approximately 68 months|The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2691420|NCT01310036|Secondary|Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R|ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Approximately 68 months|The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2691421|NCT01310036|Secondary|Progression-free Survival Per Investigator (PFS2)|PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.|Approximately 68 months|The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory. Data are reported for evaluable participants.|||months||95% Confidence Interval|Median
2691422|NCT01310036|Primary|Progression-free Survival Per RECIST, v. 1.1 (PFS1)|PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.|Approximately 68 months|The per protocol population included participants who had EGFR mutations confirmed by a study-designated central laboratory.|||months||95% Confidence Interval|Median
2691423|NCT01309997|Secondary|Percentage of CD27+ B Cells in Responders (SCR) and Non-responders|%CD27+ B cells|6 months||||percentage of CD27+ B cells||Full Range|Mean
2691424|NCT01309997|Secondary|Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale|Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.|6 months|Only patients who were evaluable at 6mo are included.|||participants|||Number
2691425|NCT01309997|Secondary|Baseline Histopathologic Score in the Two Treatment Arms|"Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis.~Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96."|Enrollment|Only patients with skin biopsies at enrollment are included.|||units on a scale||Full Range|Median
2691426|NCT01309997|Secondary|Number of Patients Achieving Improvement in Cutaneous Sclerosis|Assessed by decrease of >= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).|6 months|Only patients evaluable at 6 mo are included.|||participants|||Number
2691427|NCT01309997|Secondary|Cumulative Incidence of Treatment Failure|Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.|6 months|Only patients who were evaluable for SCR are included.|||participants|||Number
2691428|NCT01309997|Secondary|Patients Who Were Able to Taper Corticosteroids|Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline|6 months|Patients with no corticosteroid dose data missing from baseline or 6mo.|||participants|||Number
2691429|NCT01309997|Primary|Significant Clinical Response|Assessed by decline in an affected area's skin score as measured with the Vienna Skin Scale (from 4 [worst] to 2, 3 to 1, or 2 to 0 [best]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.|6 months|Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.|||participants|||Number
2691430|NCT01309919|Secondary|Insertion Time|Time of insertion of the IUD|immediate||||minutes||Standard Deviation|Mean
2691431|NCT01309919|Secondary|Satisfaction|Participant satisfaction with the IUD at 12 weeks post-insertion|12 weeks post-partum|We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call|||% of participants who received an IUD|||Number
2691432|NCT01309919|Secondary|Expulsions|Incidence of spontaneous IUD expulsion in the six months after insertion|6 months|We assessed the number of expelled IUDs for all participants who had an IUD placed|||participants|||Number
2691433|NCT01309919|Primary|Bleeding Patterns|Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum|12 weeks post-partum|We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)|||days||Full Range|Median
2691434|NCT01309893|Secondary|Overall Comfort|Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.|1 week|All eligible dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
2700985|NCT01237613|Secondary|Return to Work and Previous Physical Activities||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2691438|NCT01309880|Secondary|Slit Lamp Findings|Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.|1 week|All Dispensed Eyes|||eyes|Participants||Number
2691439|NCT01309880|Primary|Visual Acuity|Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.|Dispensing & 1-week follow up|All Eligible, Dispensed Eyes|||logMAR|Participants|Standard Deviation|Least Squares Mean
2691440|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2691441|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2691442|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue - First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||hours||95% Confidence Interval|Median
2691443|NCT01309841|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of SBMs/week||Standard Error|Least Squares Mean
2691444|NCT01309841|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|"A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: Did you feel like your bowels were completely empty after the bowel movement? Patients provided a yes or a no response. A positive change from baseline indicates improvement."|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Percent days/week||Standard Error|Least Squares Mean
2691445|NCT01309841|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
2691446|NCT01309841|Secondary|Change From Baseline in Degree of Straining|"A single-item straining question was asked via the eDiary: How much did you strain during your bowel movement? Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement."|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
2691447|NCT01309841|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of Days||Standard Error|Least Squares Mean
2691448|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Hours||95% Confidence Interval|Median
2691449|NCT01309841|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.|||Number of patients|||Number
2691450|NCT01309841|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of patients|||Number
2691451|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Both a Clinic Systolic and Diastolic Blood Pressure Response|Systolic/diastolic blood pressure is the arithmetic mean of the 3 serial sitting systolic/diastolic blood pressure measurements. Percentage of participants who achieved both a sitting clinic systolic and diastolic blood pressure response, defined as systolic blood pressure less than 130 mm Hg and diastolic blood pressure less than 80 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants||95% Confidence Interval|Number
2691452|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Target Diastolic Blood Pressure <80 mm Hg|Diastolic blood pressure is the arithmetic mean of the 3 serial sitting diastolic blood pressure measurements. Percentage of participants at Week 52 who achieved a sitting clinic diastolic blood pressure response, defined as less than 80 mm Hg.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants||95% Confidence Interval|Number
2691453|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieve Target Systolic Blood Pressure <130 mm Hg|Systolic blood pressure is the arithmetic mean of the 3 serial sitting systolic blood pressure measurements. Percentage of participants who achieve a sitting clinic systolic blood pressure response defined as less than 130 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants||95% Confidence Interval|Number
2691454|NCT01309828|Primary|Number of Participants With at Least 1 Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open- label study drug (up to 56 weeks).|Safety analysis set - All participants who received at least 1 dose of open-label study drug.|||participants|||Number
2691455|NCT01309802|Secondary|EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal|A combined reported score measuring 5 dimensions; mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels; no problems, some problems, extreme problems|baseline to 28 days|not were not collected||||||
2691456|NCT01309802|Secondary|Tissue Perfusion|Doppler perfusion imager and Periscan image analysis software|baseline to 28 days|Data were not collected||||||
2691457|NCT01309802|Secondary|Patient Satisfaction|The Optum SF-12v2® Health Survey - A Short Patient Reported Survey Measuring Health Using Excellent, Very Good, Good, Fair and Poor Indicators. On a scale from Excellent to Poor, Excellent being the maximum outcome. Good is scored as average. Patient satisfaction assessed as the percentage of participants who responded; Excellent, Very Good and Good on the health survey on average feeling between baseline and 28 days.|baseline to 28 days||||percentage of participants|||Number
2691458|NCT01309802|Secondary|Hand Function|Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure|baseline to 28 days|Data were not collected||||||
2691459|NCT01309802|Secondary|Pain Related Quality of Life|SF-12v2® Health Survey - Pain Enhanced|change from baseline to 28 days|Data were not collected,||||||
2691460|NCT01309802|Primary|Percentage of Patient Reported Pain-free Days|Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]. Subjects reporting total number of pain free days within the time period of 0-28 days.|baseline to 28 days||||percentage of pain free days|||Number
2691461|NCT01309737|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2693547|NCT01294397|Secondary|Serum Denosumab Concentration||Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29|Participants with available data|||μg/mL||Standard Deviation|Mean
2691462|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means ability to work was not affected by psoriasis, and 10 means ability to work was completely affected by psoriasis. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2691463|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable for specified timepoint for each arm, respectively.|||percentage of scheduled hours||Standard Deviation|Mean
2691464|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure for specified parameter for each arm, respectively.|||hours||Standard Deviation|Mean
2691465|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.|||percentage of participants|||Number
2691466|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed [Emp]) answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants (unemployed [UEmp]) answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||participants|||Number
2691467|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from a site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively.|||events|||Number
2691468|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline,Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||mm||Standard Deviation|Mean
2691469|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691470|NCT01309737|Secondary|Joint Pain Assessment (JPA) Score|"The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain."|Baseline, Week 8,16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691471|NCT01309737|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of Participants|||Number
2691472|NCT01309737|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of participants|||Number
2691473|NCT01309737|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691474|NCT01309737|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691475|NCT01309737|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691542|NCT01309646|Secondary|Concentrations of Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2691476|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."|||units on a scale||Standard Error|Least Squares Mean
2691477|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691478|NCT01309737|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."|||units on a scale||Standard Error|Least Squares Mean
2691479|NCT01309737|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691480|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."|||percentage of participants||95% Confidence Interval|Number
2691481|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
2691482|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.|Baseline,Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."|||percent change||Standard Error|Least Squares Mean
2691483|NCT01309737|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. 'n' signifies participants evaluable at specified time point for each arm."|||nails||Standard Deviation|Mean
2691484|NCT01309737|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'n' signifies participants evaluable at specified time point for each arm.|Baseline,Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2691485|NCT01309737|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.'n' signifies participants evaluable at specified time point for each arm.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2691486|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked)."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of participants||95% Confidence Interval|Number
2691487|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
2691488|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
2691543|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691489|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N'(number of participants analyzed) signifies the unique participants in the longitudinal model."|||percent change||Standard Error|Least Squares Mean
2691490|NCT01309737|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of BSA||Standard Deviation|Mean
2691491|NCT01309737|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."|||percent change||Standard Error|Least Squares Mean
2691492|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691493|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691494|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. N (number of participants analyzed) signifies the unique participants in the longitudinal model."|||units on a scale||Standard Error|Least Squares Mean
2691544|NCT01309646|Secondary|Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||titers||95% Confidence Interval|Geometric Mean
2691495|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2691496|NCT01309737|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
2691497|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of participants|||Number
2691498|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
2691499|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
2691500|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
2700986|NCT01237613|Secondary|Subjective Evaluation of Treatment||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2691501|NCT01309737|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
2691502|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
2691503|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
2691504|NCT01309737|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
2691505|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included participants who were randomized to study, received at least 1 dose investigational drug. Participants from 1 site were excluded due to GCP compliance issues. 'N' (number of participants analyzed) were participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.|||percent change||Standard Error|Least Squares Mean
2691583|NCT01309282|Secondary|Mean Change From Baseline in ESR at Month 24|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Millimeter (mm)/hour||Standard Deviation|Mean
2691506|NCT01309737|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
2691507|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline."|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
2691508|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
2691509|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 4,16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2691510|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2691511|NCT01309737|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
2691512|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP non-compliance. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
2691513|NCT01309737|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS): participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to good clinical practices(GCP) compliance issues. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
2691514|NCT01309672|Secondary|Number of Patients With Toxicity of Abiraterone Acetate|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|All participants receiving at least some protocol treatment|||Participants|||Number
2691515|NCT01309672|Secondary|Overall Survival||3 years||||months||95% Confidence Interval|Median
2691516|NCT01309672|Secondary|Objective Progression-free Survival|Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.|3 years||||months||95% Confidence Interval|Median
2691517|NCT01309672|Secondary|Number of Patients With PSA Partial Response|PSA reduction to < 4 ng/ml, but >0.2 ng/ml|12 months||||Participants|||Count of Participants
2691518|NCT01309672|Primary|Number of Patients With Undetectable PSA|undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.|12 months|All patients who received at least 1 dose of protocol treatment|||Participants|||Count of Participants
2691519|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.|||correlation coefficient|||Number
2691520|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance|Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses in the immediate intervention group and one subject was missing responses in the wait list control group.|||correlation coefficient|||Number
2691521|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses from the wait list control group.|||correlation coefficient|||Number
2691522|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses from both the immediate intervention group and the wait list control group.|||correlation coefficient|||Number
2691523|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks|Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject in both the immediate intervention and the wait list control groups were missing responses.|||correlation coefficient|||Number
2691524|NCT01309659|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Five subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.|||participants|||Number
2691545|NCT01309646|Secondary|Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2693548|NCT01294397|Secondary|Time to Maximum Serum Concentration (Tmax) of Etanercept||Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available Tmax data|||days||Full Range|Median
2691525|NCT01309659|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Three subjects in both the immediate intervention group and the wait list control groups were missing responses.|||participants|||Number
2691526|NCT01309659|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12."|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Two subjects in the immediate intervention group and 5 subjects in the wait list group did not respond.|||participants|||Number
2691527|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as for each of the groups there was missing responses for subjects.|||change in the total score||Standard Deviation|Mean
2691528|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 2 subjects for each of the groups did not have a response for this data.|||change in Z-score||Standard Deviation|Mean
2691529|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Wait List Control did not respond to this during their clinic visit.|||change in Z-score||Standard Deviation|Mean
2691530|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.|Baseline, 12 Week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Immediate Intervention Group did not respond to this during their clinic visit.|||change in Z-Score||Standard Deviation|Mean
2691546|NCT01309646|Secondary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2691531|NCT01309659|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~In the past month, on average, have you been feeling unusually tired during the day? is answered yes and indicated as all of the time or most of the time.~In the past month, on average, have you felt unusually weak? is answered yes and indicated as all of the time or most of the time.~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject."|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Results reported by number of participants reporting change from their baseline exhaustion, and low energy.|||participants|||Number
2691532|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.|||correlation coefficient|||Number
2691533|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Number of participants analyzed is correct- 2 subjects for Waitlist Group did not respond.|||t score||Standard Deviation|Mean
2691534|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. The number of participants analyzed is correct as 4 subjects for the wait list control group did not respond to this during their clinic visit.|||change in seconds per completed circle||Standard Deviation|Mean
2691535|NCT01309659|Secondary|Number of Participants Who Had a Hemoglobin Increase >= 1g/dL|To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12.|baseline, 12 weeks||||participants|||Number
2691536|NCT01309659|Primary|Change in 6 Minute Walk Test Results|Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.|||meters||Standard Deviation|Mean
2691537|NCT01309646|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2691538|NCT01309646|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2691539|NCT01309646|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
2691540|NCT01309646|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
2691541|NCT01309646|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.|Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691547|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691548|NCT01309646|Secondary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2691549|NCT01309646|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).|A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691550|NCT01309646|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2691551|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691552|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691553|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
2691554|NCT01309581|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)|The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).|Change from beginning of ECT treatment to end; on average 3 weeks|||||||
2691555|NCT01309581|Primary|Hamilton Rating Scale for Depression-24 (HRSD24)|"The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the gold standard clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability."|Change from beginning of ECT treatment to end; on average 3 weeks|||||||
2691556|NCT01309451|Primary|OCT CST|change in optical coherence tomography central subfield thickness|change in OCT CST from baseline to twelve months||||microns||Standard Deviation|Mean
2691557|NCT01309451|Primary|Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline|Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 12 month|The unit of measure is EYES rather than actual number of participants|||letters||Standard Deviation|Mean
2691558|NCT01309386|Secondary|Average Change From Baseline in Amount of Rescue Medication Over Time|Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Milligram (mg)||Standard Deviation|Mean
2691596|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.|||cells/μL||Standard Deviation|Mean
2691559|NCT01309386|Secondary|Number of Doses of Rescue Medication Over Time|Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Morphine-equivalent doses||Standard Deviation|Mean
2691560|NCT01309386|Secondary|Total Number of Days of Rescue Medication Over Time|Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Days||Standard Deviation|Mean
2691561|NCT01309386|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved."|Week 1, 4 and 8|Full analysis set (FAS) population; here ‘N’ signifies those participants evaluable for this outcome measure and ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Participants|||Number
2691562|NCT01309386|Secondary|Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy|Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Participants|||Number
2691563|NCT01309386|Secondary|Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8|Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Unit on scale||Standard Deviation|Mean
2691564|NCT01309386|Primary|Percentage of Participants Who Achieved Pain Control|Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.|Week 1|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Percentage of Participants||95% Confidence Interval|Number
2691565|NCT01309360|Secondary|Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.|In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level.|Outpatients were followed for the duration of hospital stay, an average of six hours.||||participants|||Number
2691566|NCT01309360|Primary|Onset Time.|Time from beginning of administration of the local anesthetic until complete sensoric block.|within 60 minutes after administration of the local anesthetic|In some cases the investigators were not able to exactly determine an onset time, so in cases of block failure (supplementation needed) or emergency situations outside this study (onset time not examined). Therefore the number of participants analyzed concerning onset time is lower then the total number of outpatients in each group.|||minutes||Standard Deviation|Mean
2691567|NCT01309360|Primary|Number of Participants With Complete Motor Blocks|To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.|Within 60 minutes after administration of the local anesthetic|The analysis was per protocol.|||participants|||Number
2691568|NCT01309360|Secondary|Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability|In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis.|Outpatients were followed for the duration of hospital stay, an average of six hours.||||participants|||Number
2691569|NCT01309360|Secondary|Maximum Concentrations of Methemoglobin|Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic.|0,1,2,3,4 hours post-dose|Methemoglobin (Met-Hb) levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent.The mean maximum Met-Hb was estimated in each group.|||percentage of methemoglobin||Standard Deviation|Mean
2691570|NCT01309360|Primary|Number of Participants With Complete Sensory Block|The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.|60 minutes after administration of the local anesthetic|The analysis was per protocol.|||participants|||Number
2691571|NCT01309308|Secondary|The Duration of Latency Until Labor|The period (in days) from the last cervical measurement to the start of second phase of labor.|15 days||||days||Standard Deviation|Mean
2691572|NCT01309308|Primary|Cervical Shortening|Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.|2days|analysis was per person who delivered|||millimeters||Standard Deviation|Mean
2691573|NCT01309282|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An Adverse Events (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Month 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.|||Participants|||Number
2691574|NCT01309282|Secondary|Number of Participants With Incidence of Infectious Events|Follow-up of the infectious events was done after Month 6 visit, Month 12 visit and Month 24 visit.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.|||Participants|||Number
2691575|NCT01309282|Secondary|Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions|An infusion reaction or injection site reaction is an event that occurs after infusion or injection which may include hypersensitivity reactions or anaphylactic reactions.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.|||Participants|||Number
2691576|NCT01309282|Secondary|Number of Participants on Each Pattern of Re-treatment|"There are two patterns of re-treatment, namely treat-to-target and according to the clinic.~Treat-to-target: a new cycle every 6 months if not in remission, with the participant receiving no new course of treatment as long as he is in remission.~On demand (according to clinic): a new cycle when, in an assessment performed at least 16 weeks after the last treatment cycle, the participant shows moderate or high disease activity [DAS28 > 3.2 or difference in DAS28 (ΔDAS28) > 0.6]"|Up to Month 24|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.|||Participants|||Number
2691577|NCT01309282|Secondary|Reason for Change From First TNF-inhibitor Therapy to Rituximab|Adverse event, primary and secondary insufficient responses and monoclonal gammopathy were the reasons for starting rituximab therapy.|At Screening|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.|||Participants|||Number
2691578|NCT01309282|Secondary|Mean Change Form Baseline in Functional Capacity at Month 24|The functional capacity was analyzed using Health Assessment Questionnaire-Disability Index (HAQ-DI). It is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each domain are scored from 0 to 3 (0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do). Overall score was computed as sum of domain scores and divided by the number of domains. A total possible score ranged from 0 (best) to 3 (worst).|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, the results are presented only for the participants with available data and who completed Month 24 visit (n=7).|||Scores on a scale||Standard Deviation|Mean
2691579|NCT01309282|Secondary|Mean Change From Baseline in Severity of Pain at Month 24|The patient's assessment of pain was performed using a 100 mm VAS ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
2691580|NCT01309282|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24|"The Patient's Global Assessment of disease activity was assessed using VAS. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
2691581|NCT01309282|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24|"The Physician's Global Assessment of disease activity was assessed using a Visual Analogue Scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
2691582|NCT01309282|Secondary|Mean Change From Baseline in C-reactive Protein at Month 24|The C-reactive protein is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Milligrams/liter||Standard Deviation|Mean
2691584|NCT01309282|Secondary|Mean Change From Baseline in SJC at Month 24|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Swollen joints||Standard Deviation|Mean
2691585|NCT01309282|Secondary|Mean Change From Baseline in TJC at Month 24|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Tender joints||Standard Deviation|Mean
2691586|NCT01309282|Primary|Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24|The disease-activity score 28 (DAS28) score is a measure of validated instrument for the assessment of the overall severity of RA disease activity calculated using the tender joint count (TJC), swollen joint count (SJC), patient's global assessment of disease activity, and erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
2691587|NCT01309269|Primary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.|||microgram (mcg)||Standard Deviation|Mean
2691588|NCT01309269|Primary|Percentage of Participants Within Pre-defined Range of Hemoglobin Values|Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.|||percentage of participants|||Number
2691589|NCT01309269|Primary|Hemoglobin Levels at Monthly Intervals|Hemoglobin levels were measured as grams/deciliter (g/dL).|Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.|||g/dL||Standard Deviation|Mean
2691590|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance|Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Resistance Analysis Set|||participants|||Number
2691591|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, All Participants|Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Full Analysis Set|||percentage of participants|||Number
2691592|NCT01309243|Secondary|Change From Baseline in Fasting Triglycerides at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
2691593|NCT01309243|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
2691594|NCT01309243|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
2691595|NCT01309243|Secondary|Change From Baseline in Fasting Total Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
2691597|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.|||cells/μL||Standard Deviation|Mean
2691598|NCT01309243|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.|Baseline to Week 96|Full Analysis Set|||percentage of participants|||Number
2691599|NCT01309243|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm.~The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time."|Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2691600|NCT01309204|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2691601|NCT01309165|Secondary|Change From Baseline in Activity Card Sort (ACS)|"The Activity Card Sort (ACS) is a client-centred interview based instrument that identifies participation in instrumental, social, and high- and low- demand physical leisure activities. A sorting methodology is used to identify whether or not the person performed the activity before their stroke and the person identifies the activities that are most important to them. The properties of ACS have been tested in various populations and there is evidence for internal consistency, construct, concurrent, and discriminant validity.~Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1."|A) Time 2- post-intervention (approx. 6 weeks from baseline), B) Time 3- 3 month follow-up (approx. 17 weeks from baseline)||||units on a scale||Standard Deviation|Mean
2691602|NCT01309165|Secondary|Change From Baseline in Stroke Impact Scale (SIS) Participation Domain|"The Stroke Impact Scale (SIS) is a stroke-specific health status measure. The scale is comprised of nine domains, of which we are using one, the Participation Domain.~Scores range from 0-100 (higher is better)."|A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)||||units on a scale||Standard Deviation|Mean
2691603|NCT01309165|Secondary|Change From Baseline in Canadian Occupational Performance Measure (COPM)|"The Canadian Occupational Performance Measure (COPM) is a standardized instrument for eliciting performance issues from the client perspective, and for capturing perceived changes in performance over time.The COPM will be used to elicit participant-selected goals. It will also be used to rate self-perceived performance and performance satisfaction for each goal. Scores range from 1 to 10 (higher is better).~Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1.~Therapist logs and institutional patient records were reviewed to establish which self-selected activities were trained during the occupational rehabilitation program. A self-selected activity was considered trained if there was any indication of practicing all or part of it or any and indication of discussions or education concerning the activity. If no evidence of training was found it was considered untrained."|A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)||||units on a scale||Standard Deviation|Mean
2691604|NCT01309165|Primary|Change From Baseline in Performance Quality Rating Scale (PQRS)|"The Performance Quality Rating Scale (PQRS) rates performance on a 10-point scale, with a score of 1 indicating can't do the skill at all and 10 indicating does the skill very well. Inter-rater reliability in the stroke population has been estimated at 0.71 (ICC). An independent observer rates performances from video recorded trials of each skill at all assessment points.~Data reported are the average of participants' trained and untrained change scores e.g. Time 2 minus Time 1 and Time 3 minus Time 1.~Therapist logs and institutional patient records were reviewed to establish which self-selected activities were trained during the occupational rehabilitation program. A self-selected activity was considered trained if there was any indication of practicing all or part of it or any and indication of discussions or education concerning the activity. If no evidence of training was found it was considered untrained."|A) Time 1- Baseline, B) Time 2- post-intervention (approx. 6 weeks from baseline), C) Time 3- 3 month follow-up (approx. 17 weeks from baseline)||||units on a scale||Standard Deviation|Mean
2691605|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)|The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|All eligible, dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
2691606|NCT01309100|Primary|Visual Acuity (Investigational vs Acuvue Oasys Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.|1 week|All eligible, dispensed eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
2691607|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)|The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|1-Week Follow-up, All Eligible, Dispensed Eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
2691608|NCT01309100|Primary|Visual Acuity (Investigational vs Air Optix Aqua Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.|1 week|All eligible, dispensed eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
2691612|NCT01308918|Secondary|Duration of the Intubating Process|The timer was started when the GLS blade was inserted between the lips and stopped when the proximal part of the tracheal cuff was passed through the vocal cords. When a patient had teeth at the superior jaw, the DLT was first inserted into the mouth prior to the insertion of the GLS blade in order to avoid rupturing the tracheal cuff. For these cases, the timer was started when the DLT was inserted between the lips.|1 hour (Post intubation)||||Seconds||Standard Deviation|Mean
2691613|NCT01308918|Primary|Number of Successfull Primary Placement of the Double Lumen Tube.|To evaluate the number of participants where GlideRite DLT Stylet® associated to the video laryngoscopy (GlideScope®)allowed the primary placement of the double lumen tube into their trachea.|1 hour (Post intubation)||||Participants|||Number
2691614|NCT01308853|Secondary|Percentage of Breasts With Improvement as Assessed by the Investigator|"Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS).~The scale has five grades ranging from worse to very much improved. Subjects defined as at least improved are assessed as improved, much improved or very much improved."|6 weeks|Intention to treat. Data from 1 participant not available.|||percentage of breasts|breasts||Number
2691615|NCT01308853|Primary|Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment|Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.|6 weeks|All included participants (Intention To Treat)|||Breasts|Breasts||Number
2691616|NCT01308840|Secondary|The Number of Participants Who Experience an Adverse Event|Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event|baseline to study completion||||participants|||Number
2691617|NCT01308840|Secondary|Median Overall Survival|Death from any cause was used.|enrollment until date of death||||months||Full Range|Median
2691618|NCT01308840|Secondary|Median Progression Free Survival|Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|time to cancer progression or death||||months||Full Range|Median
2691619|NCT01308840|Primary|The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.|end of cycle 2 of treatment||||participants|||Number
2691620|NCT01308814|Secondary|Change in Baroreceptor Sensitivity|"A finometer noninvasive blood pressure devise (FMS) was used to collect a 10 minute recording of beat-to-beat blood pressure and pulse rate during spontaneous breathing under quiet recumbent conditions. baroreflex sensitivity was computed from the most stable 5-minute segment of this 10-minute period. Cross-spectral analysis was used to estimate the average transfer function modulus (i.e., gain) between systemic blood pressure oscillations and R-R interval oscillations in the frequency range of 0.07-0.14 Hz, also known as the low frequency band. The units of this baroreflex sensitivity (BRS) were msec/mmHg.~The outcome presented here is the 12 month BRS minus baseline BRS."|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||msec/mmHg||Standard Deviation|Mean
2691621|NCT01308814|Secondary|Change in Percentage of Brachial Artery Diameter|Change (from Baseline-to-12 Month) in flow mediated dilatation (FMD) test of the brachial artery, dilatation occurs following an acute increase in blood flow, induced by via circulatory arrest in the arm for a period of time. Measured using high resolution ultrasound, yielding a measure of endothelial-dependent vasodilatation. The increase in brachial arterial diameter as a consequence of reactive hyperemia is compared to the baseline diameter of the artery and expressed as a percentage of the baseline diameter (% FMD). Flow-mediated vasodilatation at each time point was calculated as diameter of the brachial artery under reactive hyperemia minus baseline diameter of the brachial artery. The change presented here is calculated as 12 month %FMD minus baseline month %FMD.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||percent flow mediated dilatation||Standard Deviation|Mean
2691622|NCT01308814|Secondary|Percentage Meeting Criteria for Metabolic Risk [Baseline and Month 12]|Subjects will be classified as having metabolic risk if they either meet standard criteria for the metabolic syndrome (based on 3 of 5 risk factors: elevated blood pressure, fasting triglycerides, fasting glucose, waist circumference and low HDL-cholesterol) or they exhibit insulin resistance based on the homeostatic model assessment (HOMA) to derive HOMA-IR based on fasting insulin and glucose levels using the equation: HOMA-IR = fasting glucose (mmol/L) × fasting insulin (μU/mL)/22.5|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||Participants|||Count of Participants
2691623|NCT01308814|Secondary|Change in Functional Well-being as Assessed by the Medical Outcomes Study 36-item Short Form (SF-36)|The Medical Outcomes Study 36-item Short Form (SF-36) is a measure of functional well-being, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional health problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of this scale is 0-100, where higher scores indicates a more favorable health state.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||units on a scale||Standard Deviation|Mean
2693549|NCT01294397|Primary|Maximum Observed Serum Concentration (Cmax) of Etanercept||Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available Cmax data|||μg/mL||Standard Deviation|Mean
2691624|NCT01308814|Primary|Change in Stress Reactivity During Laboratory Session Including Trier Social Stress Test|Primary measures reflecting stress reactivity will consist of mean arterial pressure (MAP), vascular resistance index (VRI), plasma cortisol, and plasma IL-6. For each of these four measures, a delta score (change from rest to stress) will be calculated and then standardized as Z scores. The individual Z scores will then be averaged to yield a single Stress Reactivity profile measure (average z score) - a composite Z score reflecting magnitude of activation in the four primary stress-responsive pathways. This composite z score at baseline will be subtracted from the composite z score at 12 months to yield this outcome measure.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||composite Z score||Standard Deviation|Mean
2691625|NCT01308814|Primary|Change in Psychiatric Diagnosis as Assessed by the Structured Clinical Interview for DSM Disorders I/NP||Baseline and when prompted by CES-D score|These data were not collected because this measure is no longer the preferred method for characterizing change in depression risk. The preferred method is now to measure depressive symptoms continuously, which was done. These continuous results can be found for the CESD score in this record.||||||
2691626|NCT01308814|Primary|Change in Depressive Symptoms as Indicated by The Center for Epidemiologic Studies Depression Scale (CES-D)|Change from pre-trial (baseline) to post-trial (month 12) in the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D has a Range from 0-60, with higher scores indicating the presence of more symptomatology. A score of 16 or greater is indicative of clinically significant symptoms of depression.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||units on a scale||Standard Deviation|Mean
2691627|NCT01308788|Primary|2-year Change in OPP||Baseline and 24 month visits||||mm Hg||Standard Error|Mean
2691628|NCT01308788|Primary|2-year Change in CRA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||unitless||Standard Error|Mean
2691629|NCT01308788|Primary|2-year Change in CRA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
2691630|NCT01308788|Primary|2-year Change in CRA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
2691631|NCT01308788|Primary|2-year Change in OA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||unitless||Standard Error|Mean
2691632|NCT01308788|Primary|2-year Change in OA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
2691633|NCT01308788|Primary|2-year Change in OA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
2691634|NCT01308788|Primary|6-month Change in Ocular Perfusion Pressures (OPP)||Baseline and 6 month visits||||mm Hg||Standard Error|Mean
2691635|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)||Baseline and 6 month visits||||unitless||Standard Error|Mean
2691636|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2691637|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2691638|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)||Baseline and 6 month visits||||unitless||Standard Error|Mean
2691639|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2691640|NCT01308788|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2691641|NCT01308762|Secondary|Administration Site Reactions|Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.|Day -3 to Day 56|Safety population|||Participants|||Number
2691642|NCT01308762|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"Safety and tolerability were measured with respect to:~Safety measurements~Local tolerability at the site of intradermal injection~Incidence of adverse events."|56 days|All analyses were based on the safety population, which comprised of all patients who received at least one dose of IMP. Safety measurements and nature and incidence of adverse events were reported for the Safety population|||Participants|||Number
2691643|NCT01308749|Secondary|Mean Change in Temperature During Period 1|Temperature was collected on each participant via oral or temporal thermometer. The mean change in each group was assessed.|Week 0 to 8||||degrees fahrenheit||Standard Error|Mean
2691644|NCT01308749|Secondary|Mean Change in Prolactin Levels Over Period 1|Serum prolactin levels were collected and analyzed in participants|Week 0 to 8||||nanograms per milliliter (ng/mL)||Standard Error|Mean
2691645|NCT01308749|Secondary|Change in Mean Systolic Blood Pressure During Period 1|Change in mean systolic blood pressure during double blind phase|Week 0 to 8|The one subject who discontinued at week 1 did not have follow up data to include in the analysis.|||millimeters of mercury (mmHg)||Standard Error|Mean
2691646|NCT01308749|Secondary|Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods|The PDDBI-SV examines both adaptive and maladaptive behaviors related to autism. It has normative scores for children between 2-11 years. For children 12 years and older, the norms (11 years, 11 months) will be used. Each item is scored on a scale from 0-3. For the first 9 items, the total of individual items is summed. For items 10-18, the scores are reversed and then summed (i.e.: 0=3, 1 =2, 2=2, 3 = 0). Then the total of 0-9 and then the reversed scored items 10-18 are summed for a final total score. Higher scores indicate more impairment. The range of total scores is 0-54. ASD/Social deficits unlikely: 0-6, More information needed/borderline: 7-10, autism spectrum disorder (ASD)/social deficits likely (mild):11-14, ASD/social deficits likely (moderate): 15-29, ASD/social deficits likely (severe): 30-37, ASD/social deficits likely (extreme): 38 or higher.|Baseline to 16 Weeks|used only subjects with all data points no data carried forward|||scores on a scale||Standard Error|Mean
2691647|NCT01308749|Secondary|Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods|Efficacy measures included the Aberrant Behavior Checklist -Social Withdrawal subscale scor. The ABC which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and lethargy. A modified version of the lethargy subscale was used. Typically the Lethargy subscale includes 16 items, however, for our purposes 3 items that were specifically related to lethargy (i.e.: listlessness) were removed so that the focus could primarily be on aberrant social behavior. Differences in only the Social Withdrawal domain were assessed.The is the sum of items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC- Social Withdrawal total score ranges from 0 to 39. Higher values represent greater severity of illness.|Baseline to 16 Weeks|population of participants with all data available for mixed models analysis no data carried forward|||scores on a scale||Standard Error|Mean
2691648|NCT01308749|Secondary|Change in Mean Autism Diagnostic Observation Schedule (ADOS) Total Score|The ADOS is a semi-structured assessment used to assess and diagnose individuals suspected of having autism of varying ages, developmental levels, and language skills (from no speech to verbally fluent). The ADOS includes four modules, each requiring just 35-40 minutes to administer. The individual being evaluated is given just one of 4 modules, depending on his or her expressive language level and chronological age. The rater will observe social and communication behaviors during various activities in the appropriate module. A rater then uses a 0-3 scale to rate each type of behavior. A select number of individual items will be summed for a total score representing communication and reciprocal social interaction. In scoring all 3's are collapsed to a 2. A higher score indicates more severe impairment. Ranges of scores are as follows: Module 1: 0-24, Module 2: 0-24, Module 3: 0-22, Module 4: 0-22.|Baseline to 16 Weeks|1 patient without post baseline measures is not included|||scores on a scale||Standard Error|Mean
2691649|NCT01308749|Secondary|Change in Mean Total Social Social Responsiveness Scale (SRS) T-score|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The raw score of each individual item is summed to create a total raw score. The total raw score is then translated into a total T-scores (which are the equivalent of standard scores). Total T-scores results are as follows: 59 and below: within normal limits, 60-65: Mild range of impairment 66-75: Moderate range of impairment 76 or higher: Severe range of impairment.|0-8 weeks, blinded treatment, period 1|All participants with at least one post baseline assessment, 1 person from sequence 1 discontinued due to no post baseline measures|||T-scores||Standard Error|Mean
2691650|NCT01308749|Secondary|Change in Mean Weight|changes during period 1|between weeks 0 and 8|The subject who discontinued after 2 days did not have repeat assessments and is excluded from these analyses|||pounds||Standard Error|Mean
2691651|NCT01308749|Secondary|Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase|Blood samples will be collected to obtain proof of concept data regarding changes in afternoon plasma oxytocin levels|Week 0 to week 8|participants with oxytocin plasma levels at baseline and week 8|||picograms/mL (pg/mL)||Standard Deviation|Mean
2691652|NCT01308749|Primary|Number of Participants Who Could Tolerate Twice Daily Oxytocin|This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin.|Week 0 to week 16|all participants who recieved oxytocin at any time|||Participants|||Count of Participants
2691653|NCT01308749|Primary|Number of Participants Who Could Tolerate Twice Daily Oxytocin|This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin.|Week 0 to week 8|This is over period 1, the double blind phase (week 0 to week 8) only|||Participants|||Count of Participants
2691654|NCT01308736|Primary|Cigarette Reduction|50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.|At 6-month follow-up||||participants|||Number
2691655|NCT01308619|Secondary|Change From Baseline in Clinician's Erythema Assessment (CEA) Scores|Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst.|baseline to week 12||||units on a scale||Standard Deviation|Mean
2691656|NCT01308619|Secondary|Investigator's Global Assessment (IGA) Scores at Week 12|Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|Week 12||||participants|||Number
2691657|NCT01308619|Secondary|Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12|Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 [LL-37] peptide.|baseline to week 12|Treatment success was defined as all subjects from either treatment group with a score of clear or near clear on the Investigator’s Global Assessment (IGA) scale. Treatment failure was defined as all subjects from either treatment group with a score of mild, moderate, or severe on the IGA scale.|||micr grams protein||Standard Deviation|Mean
2691658|NCT01308619|Primary|Change From Baseline in Inflammatory Lesion Counts|Mean change in inflammatory lesion counts from baseline to week 12|baseline to week 12||||inflammatory lesions||Standard Deviation|Mean
2691659|NCT01308580|Secondary|Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel|Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points.|||litre||Standard Deviation|Mean
2691771|NCT01307462|Primary|Number of Subjects Who Failed Treatment|Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement.|Within 3 months after initiation of study medications||||Participants|||Count of Participants
2691660|NCT01308580|Secondary|Plasma Clearance (CL) for Cabazitaxel|Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points.|||Litre/hour||Standard Deviation|Mean
2691661|NCT01308580|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs.|From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)|Safety population included all randomized participants who received at least one dose of the study drug during study treatment period.|||percentage of participants|||Number
2691662|NCT01308580|Secondary|Time to First Definitive Consumption of Narcotic Medication|Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691663|NCT01308580|Secondary|Time to Definitive Weight Loss by 5% and 10% From Baseline|Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691664|NCT01308580|Secondary|Time to Definitive Deterioration of ECOG PS Score From Baseline|The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691665|NCT01308580|Secondary|Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales|The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population.|||months||95% Confidence Interval|Median
2691666|NCT01308580|Secondary|Percentage of Participants With FACT-P Total Score Response|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
2691667|NCT01308580|Secondary|Change From Baseline in FACT-P:Total Score as a Measure of HRQoL|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.|Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)|Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||95% Confidence Interval|Least Squares Mean
2691668|NCT01308580|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.|Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)|FACT-P population included randomized participants who completed FACT-P questionnaire at baseline & in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||95% Confidence Interval|Least Squares Mean
2691669|NCT01308580|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value.|||percentage of participants||95% Confidence Interval|Number
2691670|NCT01308580|Secondary|Time to Pain Progression|Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691671|NCT01308580|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value.|||percentage of participants||95% Confidence Interval|Number
2691672|NCT01308580|Secondary|Time to PSA Progression|Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691673|NCT01308580|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value.|||percentage of participants||95% Confidence Interval|Number
2691674|NCT01308580|Secondary|Time to Tumor Progression|Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691675|NCT01308580|Secondary|Progression Free Survival (PFS)|PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2691676|NCT01308580|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.|From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.|||months||95% Confidence Interval|Median
2700987|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2691677|NCT01308567|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL|FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)|Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = participants with available data for each specified category.|||units on a scale||95% Confidence Interval|Least Squares Mean
2691678|NCT01308567|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)|FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.|Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)|Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, ‘number analyzed’ = participants with available data for each specified category.|||units on a scale||95% Confidence Interval|Least Squares Mean
2691679|NCT01308567|Secondary|Skeletal Related Events (SRE) Free Survival|SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.|Baseline until occurrence of first SRE or death (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.|||months||95% Confidence Interval|Median
2691680|NCT01308567|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.|Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI >= 2 and/or mean analgesic score >= 10 points at baseline and at least one valid post-baseline value for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
2691681|NCT01308567|Secondary|Time to Pain Progression Free Survival (Pain PFS)|Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.|||months||95% Confidence Interval|Median
2691682|NCT01308567|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
2691695|NCT01308476|Primary|Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24|"Full Analysis Set (FAS) is defined as all treated patients who additionally met the study diagnosis (Chronic Obstructive Pulmonary Disease (COPD) requiring long-acting anticholinergics) and who had evaluable data in at least one effectiveness endpoint.~Only subjects who responded to the SMS/ IVR system were considered in this analysis."|||Percentage of applications||Standard Deviation|Mean
2693630|NCT01293682|Primary|Mean Change in Bone Formation: BAP (Bone-specific Alkaline Phosphatase)|Scale score for BAP (Bone-specific alkaline phosphatase) minimum value = 7 mcg/L; maximum value = 329 mcg/L Higher scale score for BAP indicates worse outcome.|baseline to 12 weeks||||mcg/L||Standard Deviation|Mean
2691683|NCT01308567|Secondary|Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)|Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.|Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.|||months||95% Confidence Interval|Median
2691684|NCT01308567|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
2691685|NCT01308567|Secondary|Time to Tumor Progression Free Survival|Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.|Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
2691686|NCT01308567|Secondary|Progression Free Survival (PFS)|PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.|Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
2691687|NCT01308567|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
2691688|NCT01308476|Secondary|Patients Satisfaction With SMS System|Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percantage of participants|||Number
2691689|NCT01308476|Secondary|Physicians Recommendation of the SMS System|Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percentage of participants|||Number
2691690|NCT01308476|Secondary|Physicians Assessment of Usefulness of the SMS System|Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percentage of participants|||Number
2691691|NCT01308476|Secondary|Patients Assessment of Usefulness of the SMS System|Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percentage of participants|||Number
2691692|NCT01308476|Secondary|Patients Compliance With SMS System|Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications.|24 weeks|FAS|||Percentage of participants answers||Standard Deviation|Mean
2691693|NCT01308476|Secondary|Response Rate Regarding Adherence|Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence.|24 weeks|FAS|||Percentage of participants|||Number
2691694|NCT01308476|Secondary|Change From Baseline in Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Week 8, Week 12, Week 16, Week 20 and Week 24|FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.|||Percent change||Standard Deviation|Mean
2691696|NCT01308463|Secondary|Survivorship Will be Measured by the Incidence of Revision or Removals|The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed|10 years Post-op|This analysis cannot be conducted due to the low number of cases available with 10 year data. There is not sufficient data to calculate survivorship. This study is being terminated since the product has been sold to another company.||||Elbows||
2691697|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction|"This is the patient's perception of satisfaction with the elbow replacement surgery.~Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction."|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.|||units on a scale|Elbows|Standard Deviation|Mean
2691698|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Function|This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.|||units on a scale|Elbows|Standard Deviation|Mean
2691699|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Pain Score|This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.|||units on a scale|Elbows|Standard Deviation|Median
2691700|NCT01308450|Primary|Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test.|"To increase the number of normal Adolescent and Adult tests to the existing Quotient System Database. To assure subjects are normal, participants will complete a standard battery of self assessment questionnaires to screen for the presence of mental health issues including: ADHD, Anxiety Disorder, Depressive Disorder or Bipolar Disorder using the following well established scales and their scoring guidelines:~ADHD Self Rating Scale (ASRS)~Zung Self-Rated Anxiety Scale (SAS)~Zung Self-Rated Depression Scale (SDS)~Mood Disorder Questionnaire (MDQ)~Quotient® ADHD System Test, Adolescent and version Each subject and their individual assessment scores will be evaluated by a physician. Those participants evaluated as normal(without ADHD) will have the results of their Quotient test added to the existing Quotient normative database of Non ADHD subjects."|12 to 18 weeks||||participants|||Number
2691701|NCT01308424|Primary|Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).|Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.|7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)|As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome.|||percentage of Participants|||Number
2691702|NCT01308294|Secondary|Tumor Response|"The assessment of the baseline disease status was performed, using CT (Computed Tomography) scan or PET (Positron Emission Tomography)/ CT scan, at screening visit or within 8 weeks preceding the screening visit. Imagery examinations occurred after the end of each vaccination cycle. The tumor response was assessed according to the classification World Health Organization (WHO) 1979 and defined as:~No evidence of disease (NED),~Stable disease (SD): change in size of all measurable lesions (the sum of the products of the greatest and perpendicular parameters), of less than a 25% increase or 25% decrease from baseline for at least 4 weeks, without appearance of new lesions or progression of any lesion.~Progressive disease (PD): appearance of new tumors, or increase in size of any measurable tumor by at least 25% of the sum of the product of the greatest and perpendicular diameter."|Change from baseline in tumor response at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25) and end of Cycle 3 (Week 40)|No patients were included in the group 3|||Participants|||Count of Participants
2691703|NCT01308294|Primary|In Vitro Frequency of NY-ESO-1-specific CD8+ T Cells|After 12 days of in vitro stimulation with NY-ESO-1 peptide, CD8+ T cells were analyzed by flow cytometry using tetramer staining.|In vitro stimulated NY-EYO-1 specific CD8+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).|No patients were included in the group 3|||Fold increase of % NY-ESO-1 CD8+T cells||Standard Deviation|Median
2691704|NCT01308294|Primary|In Vitro Frequency of Melan-A-specific CD8+T Cells After Stimulation|After 12 days of in vitro stimulation with Melan-A peptides, CD8+ T cells were analyzed by flow cytometry using tetramer staining.|In vitro stimulated Melan-A specific CD8+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40) and Follow-up (6 to 18 months after the end of Cycle 3).|No patients were included in group 3|||Fold increase of % Melan-A CD8+T cells||Standard Deviation|Median
2691705|NCT01308294|Primary|In Vitro Frequency of MAGE A3.DP4-specific CD4+ T Cells|Frequencies of specific MAGE-A3.DP4-specific CD4+ T cells were quantified by flow cytometry using class II tetramers after 10 days of in vitro stimulation.|MAGE A3.DP4 specific CD4+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40) and Follow-up (6 to 18 months after the end of Cycle 3).|No patients were included in group 3|||Fold increase of % MageA3.DP4 CD4+T||Standard Deviation|Median
2691730|NCT01307748|Primary|Percent of Baseline Level of Salivary Cortisol|Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress)|assessed at baseline (60 min prior to aroma exposure and stress), stress battery (30 min after aroma exposure and during stress), post-stress (60 min after completing stress battery)||||percentage of baseline cortisol level||Standard Error|Mean
2691731|NCT01307631|Other Pre-specified|Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0 [Time Frame: Up to 3 Years] [Designated as Safety Issue: Yes]|Data is reported in the Adverse Event table.|3 years|||||||
2691706|NCT01308294|Primary|In Vitro Frequency of MAGE A3.DP4-specific CD4+ T Cells Producing Tumor Necrosis Factor-alpha (TNF-α)|"The activation of peptide-specific CD4+ T cells was analyzed in vitro before and after vaccination by ICS.~From each patient, total CD4+ T-cells were stimulated in the presence of peptide MAGE-A3.DP4 LP (MAGE-A3243-258 peptide presented by autologous cells).~After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged.~Specific CD4+ T cells responses were identified via detection of TNF-α producing cells."|MAGE A3.DP4 specific CD4+ T-cells producing TNF-α were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).|No patients were included in the group 3|||% MAGE A3.DP4 specific CD4+T TNFα||Standard Deviation|Mean
2691707|NCT01308294|Primary|In Vitro Frequency of MAGE A3.DP4-specific CD4+ T Cells Producing Interferon-gamma (IFN-γ)|"The activation of peptide-specific CD4+ T cells was analyzed in vitro before and after vaccination by Intracellular Cytokine Staining (ICS).~From each patient, total CD4+ T-cells were stimulated in the presence of peptide MAGE-A3.DP4 LP (MAGE-A3243-258 peptide presented by autologous cells).~After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged.~Specific CD4+ T cells responses were identified via detection of IFN-γ producing cells."|MAGE A3.DP4 specific CD4+ T cells producing IFN-γ were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).|No patients were included in the group 3|||% MAGE-A3.DP4 specific CD4+T IFN-γ||Standard Deviation|Median
2691708|NCT01308294|Primary|Ex Vivo Frequency of Melan-A Specific CD8+T Cells|Cellular immunity was evaluated through the activation and the expansion of Melan-A-specific CD8+ cytotoxic T lymphocytes. Their frequency was measured in the peripheral blood mononuclear cells (PBMC) directly ex vivo (i.e. without prior in vitro expansion) by multicolor flow cytometry with Melan-A ELA tetramers. Significant T cell response is defined by at least 2-fold expansion of Melan-A-specific CD8+ T cells as compared to pre-immunotherapy.|Melan-A specific CD8+ T cells were measured in PBMC collected at the end of Cycle 1 (Week 7), end of Cycle 2 (Week 25), end of Cycle 3 (Week 40), and Follow-up (6 to 18 months after the end of Cycle 3).|No patients were included in the group 3|||Fold increase of % Melan-A CD8+T ex vivo||Standard Deviation|Median
2691709|NCT01308008|Secondary|Physical Activity|Average physical activity counts per waking minute|one year||||counts per minute||Standard Deviation|Mean
2691710|NCT01308008|Primary|Six Minute Walk Distance|Walk distance covered in feet over 6 minutes|one year||||feet||Standard Deviation|Mean
2691711|NCT01308008|Primary|Comfortable Gait Speed|Gait velocity over 6 meters|1 year||||meters per second||Standard Deviation|Mean
2691712|NCT01307956|Other Pre-specified|Overall Survival|Descriptively summarized using the method of Kaplan-Meier.|From the first date of therapy until the date the patient dies, assessed up to 100 months||||days||Full Range|Median
2691713|NCT01307956|Other Pre-specified|Progression-free Survival|Descriptively summarized using the method of Kaplan-Meier. Response and disease progression were assessed using RECIST criteria version 1.1|Patients were followed from time of consent until the date of first documented progession or date of death from any cause, whichever came first, assessed up to 100 months.||||days||Full Range|Median
2691714|NCT01307956|Secondary|Number of Patients Who Can Undergo Resection|Restaging with repeat imaging studies will be performed. If no contraindication for surgical resection is identified, resection will be performed. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.|4 weeks after completion of the radiation||||Participants|||Count of Participants
2691715|NCT01307956|Primary|Complete Pathological Response (pCR) Rate|Based on the proportion who achieve pCR based on the first 4 courses of protocol treatment. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.|Up to 8 weeks||||Participants|||Count of Participants
2691716|NCT01307930|Primary|Serum Clearance of Anidulafungin|How quickly the body eliminates anidulafungin after a single dose|0-72 hours|Noncompartmental analysis of anidulafungin clearance|||L/hr||Full Range|Median
2691717|NCT01307891|Secondary|Progression-free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Baseline through 24 months||||months||95% Confidence Interval|Median
2691718|NCT01307891|Secondary|Number of Participants With Serious Adverse Events|Patients will be assessed throughout the study for Grade 4 or 5 toxicities utilizing the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.|Baseline to 6 months||||Participants|||Count of Participants
2691719|NCT01307891|Primary|Objective Response Rate|Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.|Baseline to 6 months||||percentage of patients||95% Confidence Interval|Number
2691720|NCT01307787|Secondary|Change in Health Status: Social Interaction|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
2691732|NCT01307631|Other Pre-specified|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 Such as Progression-free Survival and Objective Tumor Response, Assessed by Immunohistochemistry (IHC)||Up to 3 years|||||||
2691733|NCT01307631|Secondary|Duration of Progression-free Survival|Estimated by using Kaplan-Meier analysis.|Up to 3 years||||months||90% Confidence Interval|Median
2691721|NCT01307787|Secondary|Change in Health Status: Psychological Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|analysis per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
2691722|NCT01307787|Secondary|Change in Health Status: Physical Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
2691723|NCT01307787|Secondary|Change in Muscle Strength of the Lower Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol,Lower extremity(LE) muscle strength data for one participant(n=1) in the WLC group is missing because knee problems prevented testing.|||newton||Standard Deviation|Mean
2691724|NCT01307787|Secondary|Change in Muscle Strength of the Upper Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol, one subject (n=1) in the intervention fitprogram withdrew from the study.|||newton||Standard Deviation|Mean
2691725|NCT01307787|Secondary|Change in Self-efficacy Function|Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|analysis per protocol, 2 subjects(n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
2691726|NCT01307787|Secondary|Change in Self-efficacy Pain and Other Symptoms|Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from 'totally disagree' (1) to 'totally agree' (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|per protocol 2 subjects( n=2) in the intervention fitprogram withdrew from the study|||units on a scale||Standard Deviation|Mean
2691727|NCT01307787|Primary|Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness|maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants'weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from < 21( sedentary with disease) to > 57 ( very good physical condition).|baseline, postintervention at 9 weeks|Some VO2 max data (n=4 in the intervention group and n=2 in the WLC group)could not be collected because of specific participant conditions at different testing time points. 4 subjects did not reach the necessary heart rate to estimate the VO2 max. One subject had hypertension and one subject had knee problems.|||ml/min/kg||Standard Deviation|Mean
2691728|NCT01307748|Secondary|Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score|Percent change from baseline in cognitive performance score on the Digit Span Backward (DSB) task. DSB scores range from 0 to 16, with greater scores indicative of better cognitive function. Positive change from baseline indicates better functioning.|Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)||||Percent change from baseline in DSB task||Standard Deviation|Mean
2691729|NCT01307748|Secondary|Electroencephalography (EEG) Frontal Asymmetry|EEG frontal asymmetry (FA) is used to assess emotional state. EEG FA processing was completed by averaging local reference EEG filtered offline from 0.1 to 70 Hz (with 60 Hz notch filter). 5-min data periods during each time were segmented into 2 seconds epochs, and the semi-automatic artifact rejection was applied. The remaining artifact-free epochs were subjected to Fast Fourier Transform (FFT) . The power spectra for individual epochs were averaged, and the measures of EEG spectral density were obtained for alpha band (8 -12.99 Hz). Square root values of power were used, and frontal hemispheric asymmetry was calculated as ((L-R)/(L+R))*100, where L and R are square root values at the homologous left and right hemisphere sites (using local average reference values at F3 and F4). With this calculation, FA negative values reflect lower alpha power (higher activation) in the left hemisphere linked to a more positive mood. This is a unit-free measure.|assessed at baseline (60 min prior to aroma exposure and stress), at the onset of aromatherapy exposure, stress battery (30 min after aroma exposure and during stress), post-stress (60 min after completing stress battery)|All participants had EEG recordings during their visit. However, some EEG data were lost due to electrode malfunction or unusable due to presence of too much noise. The data loss was similar in all study groups.|||unitless||Standard Error|Mean
2691735|NCT01307631|Primary|Progression-free Survival According to RECIST|Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From start of treatment to time of objective disease progression, assessed up to 6 months|Number of patients who had a PFS > 6 months.|||Participants|||Count of Participants
2691736|NCT01307631|Primary|Objective Tumor Response According to RECIST|Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 months|Number of patients who had an objective response.|||Participants|||Count of Participants
2691737|NCT01307618|Secondary|Gene Expression Profiles|Gene cluster analysis will be performed using deoxyribonucleic acid (DNA)-Chip Analyzer (dCHIP) software and comparisons will be made before and after treatment in each individual patient, and between responders and non-responders. Attempts will be made to identify gene expression profiles that correlate with clinical outcome.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and gene expression profiles was not measured.||||||
2691738|NCT01307618|Secondary|Overall Survival Assessed by Modified WHO Criteria|Median overall survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.|Up to 4 years||||days||95% Confidence Interval|Median
2691739|NCT01307618|Secondary|Progression-free Survival Assessed by Modified World Health Organization (WHO) Criteria|"Median progression-free survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.~The criteria for progressive disease are 1) appearance of new lesions, 2) 25% increase in the sum of the product of the largest perpendicular diameters of the indicator lesions, or 3) reappearance of any tumor."|Up to 4 years||||days||95% Confidence Interval|Median
2691740|NCT01307618|Primary|Type and Grade of Toxicity Incidents Assessed by Common Toxicity Criteria Version 4.0 (CTCAE v4.0)||Up to 4 years|Patients who experienced any adverse event were counted.|||participants|||Number
2691741|NCT01307618|Primary|Absolute Number of CD4+CD25+FoxP3+ Regulatory T Cells From Peripheral Blood|Descriptive statistics and paired t-tests will be generated to describe the frequency and absolute number of CD4+CD25+FoxP3+ cells before and after daclizumab, and also at subsequent time points. Repeated measures of analysis of variance and mixed effects models will be used to further evaluate change in numbers over time, and to compare these changes between cohorts.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and absolute number of CD4+CD25+FoxP3+Regulatory T Cells from peripheral blood was not measured.||||||
2691742|NCT01307618|Primary|Frequency of Vaccine-induced CD8+ T Cells Assessed by Enzyme-linked Immunospot (ELISPOT)|Data before treatment and after 3 vaccines will be assessed using paired t-tests within each cohort as well as a two-sample t-test of the mean post-treatment levels between cohorts. Repeated measures analysis of variance or mixed effects models will be utilized to further characterize changes in the levels of circulating T cells over time.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and frequency of vaccine-induced CD8+T cells was not measured.||||||
2691743|NCT01307579|Other Pre-specified|Genotyping Assays for Single Nucleotide Polymorphism Analysis|Descriptive statistics will be used to summarize the prevalence of single nucleotide polymorphisms.|Up to 2 years post enrollment|||||||
2691744|NCT01307579|Other Pre-specified|Negative Predictive Value of Galactomannan and Beta-D Glucan Assays for the Diagnosis of Proven or Probable IFI|Negative predictive value of galactomannan and beta-D glucan assays for the diagnosis of proven or probable IFI. Negative predictive value will be estimated for the two fungal biomarkers together.|Up to 5 months since enrollment|||||||
2691745|NCT01307579|Other Pre-specified|Positive Predictive Value of Galactomannan and Beta-D Glucan Assays for the Diagnosis of Proven or Probable IFI|Positive predictive value of galactomannan and beta-D glucan assays for the diagnosis of proven or probable IFI. Positive predictive value will be estimated for the two fungal biomarkers together.|Up to 5 months since enrollment|||||||
2691746|NCT01307579|Other Pre-specified|Specificity of Galactomannan and Beta-D Glucan Assays for the Diagnosis of Proven or Probable IFI|Specificity of galactomannan and beta-D glucan assays for the diagnosis of proven or probable IFI. Specificity will be estimated for the two fungal biomarkers together.|Up to 5 months since enrollment|||||||
2691747|NCT01307579|Other Pre-specified|Sensitivity of Galactomannan and Beta-D Glucan Assays for the Diagnosis of Proven or Probable IFI|Sensitivity for the diagnosis of proven or probable IFI will be determined for the fungal biomarkers galactomannan and beta-D glucan assays. Sensitivity will be estimated for the combination of the two fungal biomarkers.|Up to 5 months since enrollment|||||||
2691748|NCT01307579|Secondary|Percentage of Participants That Need Empiric Antifungal Therapy|The percentage of participants requiring empiric antifungal therapy will be determined based on the presence of prolonged fever and neutropenia during each neutropenia course.|Up to 5 months since enrollment|Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)|||Percentage of participants||95% Confidence Interval|Number
2691749|NCT01307579|Secondary|Overall Survival|Kaplan Meier method will be used to estimate overall survival. Time to event is from enrollment to date of death (by any cause). Participants are censored at last contact or 2 years anniversary of enrollment into this study, whichever occurred first.|Up to 2 years post enrollment|Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)|||Percentage of participants||95% Confidence Interval|Number
2691967|NCT01306305|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject lost to follow up and one subject who withdrew consent|||Number of subjects|||Number
2691750|NCT01307579|Secondary|Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)|Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.|Up to 5 months since enrollment|Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)|||Percentage of participants||95% Confidence Interval|Number
2691751|NCT01307579|Primary|Percentage of Participants With Proven or Probable Invasive Fungal Infections (IFI)|Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).|Up to 5 months since enrollment|Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)|||Percentage of participants||95% Confidence Interval|Number
2691752|NCT01307501|Secondary|Metastatic Disease Spread as Measured by Imaging|Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.|Months 3, 6, 12, 24, 36, 48, and 60|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||Participants|||Count of Participants
2691753|NCT01307501|Secondary|Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)|An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to 30 days post-cryoablation|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).|||Participants|||Count of Participants
2691754|NCT01307501|Secondary|Cryoablation Technical Success of the Study Cryoablation Procedure|A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin).|Up to 60 months|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).|||percentage of tumors|Tumors||Number
2691755|NCT01307501|Secondary|Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60|The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.|Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||score on a scale||Standard Deviation|Mean
2691756|NCT01307501|Secondary|Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60|The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function.|Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||score on a scale||Standard Deviation|Mean
2691757|NCT01307501|Secondary|Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60|ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.|Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||score on a scale||Standard Deviation|Mean
2691758|NCT01307501|Secondary|Time in Days to Disease Recurrence or Progression Following Study Cryoablation|Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a >20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented.|Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days)|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||percentage of participants|||Number
2699757|NCT01247363|Secondary|Maximum Drug Concentration (Cmax)||Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose|Participants who were administered study drug.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2691759|NCT01307501|Secondary|Overall Disease-Specific Participant Survival Post-Cryoablation|Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death.|Up to Month 60|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||percentage of participants|||Number
2691760|NCT01307501|Secondary|Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48|Local tumor control was achieved if the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of the greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.|Baseline and Months 3, 6, 12, 24, 36, and 48|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||percentage of tumors|Tumors|95% Confidence Interval|Number
2691761|NCT01307501|Primary|Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60|Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.|Baseline and Month 60|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.|||percentage of tumors|Tumors|95% Confidence Interval|Number
2691762|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale|Lee symptom scale (LSS) has subscales with min=0, max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a negative change is correlated with improvement in clinical outcome.|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
2691763|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)|"HAP subscales have min=0 and max=94; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.~Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.~Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.~Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78."|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
2691764|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)|"FACT-BMT subscales have various min/max, see below; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.~FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)"|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
2691765|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)|SF-36 subscales have min=0 and max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
2691766|NCT01307462|Secondary|Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%||Baseline to 6 months|24 out of 36 subjects were evaluable at 6mo due to missing data.|||Participants|||Count of Participants
2691767|NCT01307462|Secondary|Number of Subjects With Improvements in Other Chronic GVHD Characteristics|Only includes subjects who had complete or partial response according to the National Institute of Health (NIH) consensus criteria.|Baseline and 3 months|33 of 36 participants were evaluable at 3 months due to missing provider survey data|||Participants|||Count of Participants
2691768|NCT01307462|Secondary|Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone)||Baseline to 6 months|Data were not collected||||||
2691769|NCT01307462|Secondary|Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO||Baseline and 6 months||||Participants|||Count of Participants
2691770|NCT01307462|Secondary|Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result|National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0)|From baseline to 6 months||||Participants|||Count of Participants
2691772|NCT01307449|Secondary|Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.1|Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR < 0.05) positive enrichment of B cell module M156.1 is reported.|Day 7|One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can’t be used for the analysis in the absence of baseline.|||Participants|||Count of Participants
2691773|NCT01307449|Secondary|Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.0|Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR < 0.05) positive enrichment of B cell module M156.0 is reported.|Day 7|One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can’t be used for the analysis in the absence of baseline.|||Participants|||Count of Participants
2691774|NCT01307449|Secondary|Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module S3|Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR < 0.05) positive enrichment of B cell module S3 is reported.|Day 7|One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can’t be used for the analysis in the absence of baseline.|||Participants|||Count of Participants
2691775|NCT01307449|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M73|Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M73 is reported.|Day 7|One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can’t be used for the analysis in the absence of baseline.|||Participants|||Count of Participants
2691776|NCT01307449|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M11|Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M11 is reported.|Day 7|One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can’t be used for the analysis in the absence of baseline.|||Participants|||Count of Participants
2691777|NCT01307449|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15|Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M4.15 is reported.|Day 7|One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can’t be used for the analysis in the absence of baseline.|||Participants|||Count of Participants
2691778|NCT01307423|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.|Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 168.93 weeks and 229.36 weeks for apremilast 30 mg BID|Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||Participants|||Count of Participants
2691779|NCT01307423|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Placebo Controlled Phase|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.|Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population included participants who were randomized and received at least one dose of IP.|||Participants|||Count of Participants
2691780|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 20. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2691781|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval was based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2691782|NCT01307423|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 70% improvement in 78 tender joint count; ≥ 70% improvement in 76 swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2691783|NCT01307423|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 50% improvement in 78 tender joint count; ≥ 50% improvement in 76 swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2691784|NCT01307423|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease. A Good response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants|||Number
2691785|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by ≥ 1 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2691794|NCT01307423|Secondary|Change From Baseline in the SF-36v2 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691786|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2691787|NCT01307423|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691788|NCT01307423|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691789|NCT01307423|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691790|NCT01307423|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691791|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691792|NCT01307423|Secondary|Change From Baseline in the Participants Assessment of Pain Using the Visual Analog Scale at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
2691793|NCT01307423|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Measure Description: Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2692044|NCT01305564|Secondary|Filter Migration|Rate of filter indwell complications of: migration >2cm.|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of migration.|||percentage of participants||95% Confidence Interval|Number
2691795|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2691796|NCT01307423|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in 78 tender joint count; ≥ 20% improvement in 76 swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||Percentage of Participants||95% Confidence Interval|Number
2691797|NCT01307423|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691798|NCT01307423|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691799|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691800|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691801|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691802|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691803|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691804|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||Percentage of participants|||Number
2691805|NCT01307423|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|The EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on th DAS-28. Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2 A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691806|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691807|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691808|NCT01307423|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2699957|NCT01245439|Secondary|Percentage of Participants With All-Cause Discontinuation|Participants who discontinued treatment due to any reason were included in this measure.|24 weeks|Safety population|||percentage of participants|||Number
2691809|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691810|NCT01307423|Secondary|Percentage of Participants With ≥ 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691811|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2691812|NCT01307423|Secondary|Change From Baseline in Disease Activity Score (DAS 28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2691813|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16|||units on a scale||Standard Error|Least Squares Mean
2691814|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2691815|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2691824|NCT01307423|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
2691816|NCT01307423|Secondary|Change From Baseline in Participants Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
2691817|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16, or who did not have sufficient data for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691818|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2691819|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2691820|NCT01307423|Secondary|Change From Baseline in the Disease Activity Score (DAS28) After 16 Weeks of Treatment|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2691821|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2691822|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline to Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2691823|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2691825|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691826|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2691827|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16|||units on a scale||Standard Error|Least Squares Mean
2691828|NCT01307423|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2691829|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2691830|NCT01307423|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: -Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); -Patient's global assessment of disease activity (measured on a 100 mm VAS); -Physician's global assessment of disease activity (measured on a 100 mm VAS); -Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); -C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; one participant randomized in error and not receiving any dose of investigational product was excluded. Participants who withdrew early or did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2691831|NCT01307397|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|Baseline until death (maximum up to 46 months)|Safety population|||Months||95% Confidence Interval|Median
2691832|NCT01307397|Secondary|Percentage of Participants Who Died||Baseline until death (maximum up to 46 months)|Safety population|||Percentage of participants|||Number
2691873|NCT01307267|Secondary|Overall Survival in Portion A|Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.|||months||95% Confidence Interval|Median
2691833|NCT01307397|Secondary|Progression Free Survival (PFS)|PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.|Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population|||Months||95% Confidence Interval|Median
2691834|NCT01307397|Secondary|Percentage of Participants With PD Assessed According to RECIST v1.1 or Death|PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.|Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population|||Percentage of Participants|||Number
2691835|NCT01307397|Secondary|Time to Response|Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response.|Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population. Number of participants analyzed = participants with measurable disease at baseline.|||Months||Full Range|Median
2691836|NCT01307397|Secondary|Duration of Response|The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.|From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months])|Safety population. Number of participants analysed=participants who achieved CR or PR.|||Months||95% Confidence Interval|Median
2691837|NCT01307397|Secondary|Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|"BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions.~Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response."|Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population. Number of participants analyzed = participants with measurable disease at baseline.|||Percentage of Participants||95% Confidence Interval|Number
2691838|NCT01307397|Secondary|Percentage of Participants Who Received Any Concomitant Medications|Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.|Baseline up to 46 months|Safety population|||Percentage of Participants|||Number
2691839|NCT01307397|Secondary|Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status|ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.|Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)|Safety population|||Percentage of Participants|||Number
2691840|NCT01307397|Primary|Dose Intensity of Vemurafenib|Dose intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.|Baseline up to end of treatment or death (maximum upto 46 months)|Safety Population|||Percentage of planned dose||Standard Deviation|Mean
2691841|NCT01307397|Primary|Mean Total Vemurafenib Dose Per Day|"Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.~Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment."|Baseline up to end of treatment or death (maximum up to 46 months)|Safety population|||Grams||Standard Deviation|Mean
2691842|NCT01307397|Primary|Duration of Vemurafenib Treatment|"Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.~Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation."|Baseline up to end of treatment or death (maximum upto 46 months)|Safety population|||Months||Standard Deviation|Mean
2691843|NCT01307397|Primary|Mean Cumulative Dose of Vemurafenib||Baseline up to end of treatment or death (maximum up to 46 months)|Safety population|||Grams||Standard Deviation|Mean
2691844|NCT01307397|Primary|Percentage of Participants With AEs of Special Interest|AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).|Baseline up to 28 days post end of treatment (maximum up to 46 months)|Safety population|||Percentage of participants|||Number
2691845|NCT01307397|Primary|Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation|An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.|Baseline up to 28 days post end of treatment (maximum up to 46 months)|Safety population|||Percentage of participants|||Number
2691846|NCT01307397|Primary|Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0|"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: Grade 3 means Severe; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means Life-threatening, Disabling; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable."|Baseline up to 28 days post end of treatment (maximum up to 46 months)|Safety population. Number of participants analyzed = participants with measurable disease at baseline|||Percentage of participants|||Number
2691847|NCT01307319|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2691848|NCT01307319|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2691849|NCT01307267|Other Pre-specified|Patient-Reported Outcomes of PF-05082566 and Rituximab When Given in Combination in Follicular Lymphoma Participants|This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.|Up to 2 years|This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.||||||
2691850|NCT01307267|Other Pre-specified|Exploratory Pharmacodynamic Biomarkers|This was an exploratory endpoint and no data were collected.|Days 1 and 21|This was an exploratory endpoint and no data were collected.||||||
2691851|NCT01307267|Other Pre-specified|Biomarkers Linked With Immunomodulation and Cytokine Release|This was an exploratory endpoint and no data were collected.|Days 1, 14, 29 and 57|This was an exploratory endpoint and no data were collected.||||||
2692045|NCT01305564|Secondary|Filter Fracture|Rate of filter fracture|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of fracture.|||percentage of participants||95% Confidence Interval|Number
2691852|NCT01307267|Secondary|Overall Survival in Portion B|Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.|||months||95% Confidence Interval|Median
2691853|NCT01307267|Secondary|Progression-Free Survival in Portion B|Progression-free survival in Portion B was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective PD (per Cheson 2007) or death due to any cause, whichever occurred first. Objective PD per Cheson 2007 was defined as: PD of index lesions (>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.|||months||95% Confidence Interval|Median
2691854|NCT01307267|Secondary|Time to Response in Portion B|Time to response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from Cycle 1 Day 1 to the first documentation of objective response. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or >=50% decrease in the SPD of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B, had tumor assessments for lymphoma, and achieved an objective response.|||months||Full Range|Median
2691855|NCT01307267|Secondary|Duration of Response in Portion B|Duration of Response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from first documentation of objective response to the date of first documentation of objective PD or death due to any cause. Objective PD per Cheson 2007 was defined as: PD of index lesions (>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion >=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B, had tumor assessments for lymphoma, and achieved an objective response.|||months||95% Confidence Interval|Median
2691856|NCT01307267|Secondary|Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B|Objective Response in Portion B was defined as BOR of CR or PR according to Cheson 2007 criteria. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or >=50% decrease in the sum of the product diameters [SPD] of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion >=15 mm in greatest transverse diameter [GTD], unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.|||percentage of participants||95% Confidence Interval|Number
2691857|NCT01307267|Secondary|Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B|Categorical summarization criteria for QTc interval: 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.|Up to approximately 2 years|"All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had post-baseline QTc data. Number Analyzed represents those participants who had data for each specified category."|||Participants|||Count of Participants
2691858|NCT01307267|Secondary|Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B|ADA for PF-05082566 and rituximab was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23. Positive ADA for rituximab: titer>=1.88.|Up to approximately 2 years|"All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and was tested for ADA. Number Analyzed represents those participants who had data for each specified category."|||Participants|||Count of Participants
2691859|NCT01307267|Secondary|Rituximab Cmax and Ctrough in Portion B|Cmax and Ctrough of rituximab were observed directly from data.|Day 1 pre-dose of Cycle 2|All participants who received at least 1 dose of rituximab in Portion B and had Cmax or Ctrough data for rituximab. No data were collected for this Outcome Measure.||||||
2691860|NCT01307267|Secondary|PF-05082566 Vss in Portion B|Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2691861|NCT01307267|Secondary|PF-05082566 CL in Portion B|CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2691862|NCT01307267|Secondary|PF-05082566 AUCtau in Portion B|AUCtau of PF-05082566 was determined using linear/log trapezoidal method.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691863|NCT01307267|Secondary|PF-05082566 AUCinf in Portion B|AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose.|All participants who received at least 1 dose of PF-05082566 in Portion B and had AUCinf data.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691864|NCT01307267|Secondary|PF-05082566 AUClast in Portion B|AUClast of PF-05082566 was determined by linear/log trapezoidal method.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691865|NCT01307267|Secondary|PF-05082566 Tmax in Portion B|Tmax of PF-05082566 was observed directly from data as time of Cmax.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||hr||Full Range|Median
2691866|NCT01307267|Secondary|PF-05082566 Ctrough in Portion B|Ctrough of PF-05082566 was observed directly from data.|Day 1 pre-dose of Cycle 2|All participants who received at least 1 dose of PF-05082566 in Portion B and had data for Ctrough.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2691867|NCT01307267|Secondary|PF-05082566 Cmax in Portion B|Cmax of PF-05082566 was observed directly from data.|Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2691868|NCT01307267|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B|For vital signs in Portion B, blood pressure, pulse rate, and body temperature were measured. Clinical significance was determined by the investigator.|Up to approximately 2 years|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.|||Participants|||Count of Participants
2691869|NCT01307267|Secondary|Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B|Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.|Up to approximately 2 years|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had chemistries laboratory test data.|||Participants|||Count of Participants
2691870|NCT01307267|Secondary|Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B|Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.|Up to approximately 2 years|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had hematology laboratory test data.|||Participants|||Count of Participants
2691871|NCT01307267|Secondary|Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).|Up to approximately 4 years|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.|||Participants|||Count of Participants
2691872|NCT01307267|Secondary|Number of Participants With Treatment-Emergent AEs and SAEs in Portion B|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.|Up to approximately 4 years|All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.|||Participants|||Count of Participants
2693631|NCT01293682|Primary|Mean Change in Bone Resorption: NTX (N-terminal Telopeptide)|Scale score for NTX (N-terminal telopeptide) minimum value = 4.2 nmol BCE; maximum value = 3688 nmol BCE Higher scale score for NTX indicates worse outcome.|baseline to 12 weeks||||nmol||Standard Deviation|Mean
2691874|NCT01307267|Secondary|Progression-Free Survival in Portion A|Progression-free survival: the time from Cycle 1 Day 1 to the date of the first documentation of objective PD or death due to any cause, whichever occurred first. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm; or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.|||months||95% Confidence Interval|Median
2691875|NCT01307267|Secondary|Time to Response in Portion A|Time to response: the time from Cycle 1 Day 1 to the first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1). BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-PD, indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes decreased to normal size); PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of PF-05082566 in Portion A and and achieved an objective response.|||months||Full Range|Median
2691876|NCT01307267|Secondary|Duration of Response in Portion A|Duration of response: the time from first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1) to the date of first documentation of objective progression of disease (PD) or death due to any cause. Objective PD per RECIST version 1.1: >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 millimeters (mm); or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions. This outcome measure reports the individual values for evaluable participants (instead of medians etc) due to the limited number of events.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|"All participants who received at least 1 dose of PF-05082566 in Portion A and achieved an objective response. Number analyzed represents the number of such participants for each specified category."|||months|||Number
2691877|NCT01307267|Secondary|Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A|Objective response: confirmed best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-progression of disease (non-PD), indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.|Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)|All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.|||percentage of participants||95% Confidence Interval|Number
2691878|NCT01307267|Secondary|Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A|Categorical summarization criteria for QTc interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate): 1) absolute value of >450 to <=480 milliseconds (msec), >480 to <=500 msec, >500 msec; 2) a maximum change from baseline of >30 to <=60 msec or >60 msec.|Up to approximately 2 years|"All participants who received at least 1 dose of PF-05082566 in Portion A and had post-baseline QTc data. Number Analyzed represents those participants who had data for each specified category."|||Participants|||Count of Participants
2691879|NCT01307267|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A|ADA for PF-05082566 was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer>=6.23.|Up to approximately 2 years|All participants who received at least 1 dose of PF-05082566 in Portion A and was tested for ADA.|||Participants|||Count of Participants
2691880|NCT01307267|Secondary|PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A|Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||milliliter per kilogram (mL/kg)||Geometric Coefficient of Variation|Geometric Mean
2691881|NCT01307267|Secondary|PF-05082566 Clearance (CL) in Portion A|CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2. It was reported in units of milliliter per hour per kilogram (mL/hr/kg).|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||milliliter/hour/kilogram (mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
2691882|NCT01307267|Secondary|PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A|AUCtau of PF-05082566 was determined using linear/log trapezoidal method.|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691883|NCT01307267|Secondary|PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A|AUCinf = AUClast + (Clast*/kel), where Clast* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691884|NCT01307267|Secondary|PF-05082566 Area Under the Serum Concentration-Time Profile (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) in Portion A|AUClast of PF-05082566 was determined by linear/log trapezoidal method.|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||microgram*hour per milliliter (μg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2691885|NCT01307267|Secondary|PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A|Tmax of PF-05082566 was observed directly from data as time of Cmax.|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||hours (hr)||Full Range|Median
2691886|NCT01307267|Secondary|PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A|Ctrough of PF-05082566 was observed directly from data.|Day 1 pre-dose of Cycle 2|All participants who received at least 1 dose of PF-05082566 in Portion A and had data for Ctrough.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2691887|NCT01307267|Secondary|PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A|Cmax of PF-05082566 was observed directly from data.|Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose|"All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category."|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2691888|NCT01307267|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A|For vital signs in Portion A, blood pressure and pulse rate were measured. Clinical significance was determined by the investigator.|Up to approximately 2 years|All participants who received at least 1 dose of PF-05082566 in Portion A.|||Participants|||Count of Participants
2691889|NCT01307267|Secondary|Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A|Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.|Up to approximately 2 years|"Number of Participants Analyzed represents all participants who received at least 1 dose of PF-05082566 in Portion A and had chemistries laboratory test data. Number Analyzed represents all participants who received at least 1 dose of PF-05082566 in Portion A and had data for the specified category."|||Participants|||Count of Participants
2691890|NCT01307267|Secondary|Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A|Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.|Up to approximately 2 years|All participants who received at least 1 dose of PF-05082566 in Portion A and had hematology laboratory test data.|||Participants|||Count of Participants
2691891|NCT01307267|Secondary|Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).|Up to approximately 2 years|All participants who received at least 1 dose of PF-05082566 in Portion A.|||Participants|||Count of Participants
2691892|NCT01307267|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.|Up to approximately 2 years|All participants who received at least 1 dose of PF-05082566 in Portion A.|||Participants|||Count of Participants
2691903|NCT01307033|Secondary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
2691893|NCT01307267|Primary|Number of Participants With DLTs in First 2 Cycles of Portion B|DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.|Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)|All participants who received at least 1 dose of PF-05082566 and 1 dose of rituximab in the first 2 cycles of Portion B.|||Participants|||Count of Participants
2691894|NCT01307267|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A|DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.|Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)|All participants who received at least 1 dose of PF-05082566 in the first 2 cycles of Portion A.|||Participants|||Count of Participants
2691895|NCT01307111|Primary|Patient Perceived Pain on a 100-point Visual Analogue Scale.|Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.|Prior to insertion, immediately after insertion, and prior to clinic discharge.||||units on a scale||Standard Deviation|Mean
2691896|NCT01307111|Secondary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.|Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).|Immediately post IUD insertion||||units on a scale||Standard Deviation|Mean
2691897|NCT01307098|Primary|Number Of Participants Reporting TEAEs And Infusion-Related Reactions (IRRs)|Safety and tolerability of sebelipase alfa was primarily assessed by monitoring the number of participants reporting treatment-emergent adverse events (TEAEs), including serious adverse events, and infusion-related reactions (IRRs). The number of participants who discontinued from the study due to a TEAE is also presented. An IRR was defined as any adverse event that occurred between the start of the infusion and 4 hours after completion of the infusion and was assessed by the Investigator as at least possibly related to study drug. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Screening up to Day 52|Safety Analysis Set: All participants who received any full or partial dose of sebelipase alfa in this study.|||participants|||Number
2691898|NCT01307046|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)||8 weeks|All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2691899|NCT01307046|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"|||mmHg||95% Confidence Interval|Least Squares Mean
2691900|NCT01307046|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"|||mmHg||95% Confidence Interval|Least Squares Mean
2691901|NCT01307033|Primary|Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)||Up to 52 weeks|All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks).|||Percentage of Participants|||Number
2691902|NCT01307033|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
2691904|NCT01307020|Secondary|Percentage of Patients Using Rescue Medication at 6 Hours|Percentage of patients using rescue medication at 6 hours post-dosing.|Baseline to 6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment|||percentage of patients|||Number
2691905|NCT01307020|Secondary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %|4, 8 and 12 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment|||percentage of patient|||Number
2691906|NCT01307020|Primary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %|6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment|||percentage of patients|||Number
2691907|NCT01307007|Primary|Changes in Blood Markers|Changes in blood markers of phosphate|Day 35||||mg/dL||Standard Deviation|Mean
2691908|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.|||units on a scale||Standard Deviation|Mean
2691909|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.|||units on a scale||Standard Deviation|Mean
2691910|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat|Means for the change from baseline to follow-up visit 2|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
2691911|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis.|||units on a scale||Standard Deviation|Mean
2691912|NCT01306942|Secondary|Number of Participants With Correlation Between Lymphocytosis and Efficacy.|Efficacy (ORR, CBR, TTP, RD and PFS) was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria, and were correlated Lymphocytes, that were measured in the weekly hematology analyses performed within the first cycle.|Cycle 1||||Participants|||Count of Participants
2691913|NCT01306942|Secondary|Phosphorylation Status of Phosphorylated ERK (p-ERK) in Skin After Treatment (Phase II)|"Phosphorylated extracellular signal-regulated kinases (p-ERK) 1 and 2 expression were analyzed in the skin biopsies taken at the cycle 1 day 1 at 0 hours and 8 hours, only in patients accepting to participate.~A semi-quantitative H-score (or histo score) determined by the estimation of the percentage of tumour cells positively stained with low, medium, or high staining intensity. The final score is determined after applying a weighting factor to each estimate. The formula used is H-score = (low %) × 1 + (medium %) × 2 + (high %) × 3, and the results ranged from minimum 0 to maximum 300.~Aim: to confirm the mechanism of action identified in preclinical models where the combination of dasatinib and trastuzumab show a statistically significant reduction in the phosphorylated levels of ERK"|Cycle 1 day 1 at 0 hours and at 8 hours|Skin biopsies could only be obtained in 6 participants at cycle 1 day 1 at 0 hours and 8 hours.|||score on a scale||95% Confidence Interval|Mean
2691914|NCT01306942|Secondary|Phosphorylation Status of Phosphorylated ERK (p-ERK) in Skin After Treatment (Phase I)|"p-ERK was analyzed in the skin biopsies taken at cycle 1 day 1 at 0 hours and 8 hours, cycle 1 day 4 at 8 hours, and cycle 2 day 1 at 8 hours, only in patients accepting to participate.~A semi-quantitative H-score (or histo score) determined by the estimation of the percentage of tumour cells positively stained with low, medium, or high staining intensity. The final score is determined after applying a weighting factor to each estimate. The formula used is H-score = (low %) × 1 + (medium %) × 2 + (high %) × 3, and the results ranged from minimum 0 to maximum 300.~Aim: to confirm the mechanism of action identified in preclinical models where the combination of dasatinib and trastuzumab show a statistically significant reduction in the phosphorylated levels of ERK"|Cycle 1 day 1 at 0 hours and at 8 hours, cycle 1 day 4 at 8 hours and cycle 2 day 1 at 8 hours|Skin biopsies could only be obtained in 5 participants at cycle 1 day 1 at 0 hours and 8 hours, cycle 1 day 4 at 8 hours and cycle 2 day 1 at 8 hours.|||score on a scale||95% Confidence Interval|Mean
2691915|NCT01306942|Secondary|Phosphorylation Status of Phosphorylated AKT (p-AKT) in Skin After Treatment (Phase II)|"p-AKT was analyzed in the skin biopsies taken at cycle 1, day 1 at 0 hours and 8 hours, only in patients accepting to participate.~A semi-quantitative H-score (or histo score) determined by the estimation of the percentage of tumour cells positively stained with low, medium, or high staining intensity. The final score is determined after applying a weighting factor to each estimate. The formula used is H-score = (low %) × 1 + (medium %) × 2 + (high %) × 3, and the results ranged from minimum 0 to maximum 300.~Aim: to confirm the mechanism of action identified in preclinical models where the combination of dasatinib and trastuzumab show a statistically significant reduction in the phosphorylated levels of AKT"|Cycle 1 day 1 at 0 hours and at 8 hours|Skin biopsies could only be obtained in 6 participants at cycle 1 day 1 at 0 hours and 8 hours.|||score on a scale||95% Confidence Interval|Mean
2691916|NCT01306942|Secondary|Phosphorylation Status of Phosphorylated AKT (p-AKT) in Skin After Treatment (Phase I)|"p-AKT was analyzed in the skin biopsies taken at cycle 1, day 1 at 0 hours and 8 hours, and cycle 2 day 1, only in patients accepting to participate.~A semi-quantitative H-score (or histo score) determined by the estimation of the percentage of tumour cells positively stained with low, medium, or high staining intensity. The final score is determined after applying a weighting factor to each estimate. The formula used is H-score = (low %) × 1 + (medium %) × 2 + (high %) × 3, and the results ranged from minimum 0 to maximum 300.~Aim: to confirm the mechanism of action identified in preclinical models where the combination of dasatinib and trastuzumab show a statistically significant reduction in the phosphorylated levels of AKT"|Cycle 1 day 1 at 0 hours and at 8 hours and cycle 2 day 1|Skin biopsies could only be obtained in 5 participants at cycle 1 day 1 at 0 hours and 8 hours and cycle 2 day 1.|||score on a scale||95% Confidence Interval|Mean
2691917|NCT01306942|Secondary|Phosphorylation Status of Phosphorylated SRC (p-SRC) in Skin After Treatment (Phase II)|"p-SRC was analyzed in the skin biopsies taken at cycle 1 day 1 at 0 hours and 8 hours, only in patients accepting to participate.~A semi-quantitative H-score (or histo score) determined by the estimation of the percentage of tumour cells positively stained with low, medium, or high staining intensity. The final score is determined after applying a weighting factor to each estimate. The formula used is H-score = (low %) × 1 + (medium %) × 2 + (high %) × 3, and the results ranged from minimum 0 to maximum 300.~Aim: to confirm the mechanism of action identified in preclinical models where the combination of dasatinib and trastuzumab show a statistically significant reduction in the phosphorylated levels of SRC."|Cycle 1 day 1 at 0 hours and at 8 hours|Skin biopsies could only be obtained in 6 participants at cycle 1 day 1 at 0 hours and 8 hours.|||score on a scale||95% Confidence Interval|Mean
2691918|NCT01306942|Secondary|Phosphorylation Status of Phosphorylated SRC (p-SRC) in Skin After Treatment (Phase I)|"p-SRC was analyzed in the skin biopsies taken at cycle 1 day 1 at 0 hours and 8 hours, cycle 1 day 4 and cycle 2 day 1, only in patients accepting to participate.~A semi-quantitative H-score (or histo score) determined by the estimation of the percentage of tumour cells positively stained with low, medium, or high staining intensity. The final score is determined after applying a weighting factor to each estimate. The formula used is H-score = (low %) × 1 + (medium %) × 2 + (high %) × 3, and the results ranged from minimum 0 to maximum 300.~Aim: to confirm the mechanism of action identified in preclinical models where the combination of dasatinib and trastuzumab show a statistically significant reduction in the phosphorylated levels of SRC."|Cycle 1 day 1 at 0 hours and at 8 hours, cycle 1 day 4 and cycle 2 day 1|Skin biopsies could only be obtained in 5 participants at cycle 1 day 1 at 0 hours and 8 hours, cycle 1 day 4 and cycle 2 day 1.|||score on a scale||95% Confidence Interval|Mean
2691919|NCT01306942|Secondary|Phosphorylated AKT (p-AKT) Protein Expression Change in Peripheral Blood Mononuclear Cells After 8 Hours of Treatment (Phase II)|Sequential peripheral blood mononuclear cells (PBMCs) on Cycle 1 Day 1 before treatment and 8 hours (h) after treatment (0h and 8h) were assessed to explore changes in the expression of p-AKT proteins measured by enzyme-linked immunosorbent assay (ELISA). For ELISA analyses, a duplicate of 100 µg of the extract was used to detect p-AKT (Ser473). ELISA is a plate-based assay technique designed for detecting and quantifying proteins. The instrumentation used for protein signal-detection is an absorbance spectrophotometer (AS), which measures Absorbance (A). A is the quantity of light absorbed by a sample. As different compounds absorb light at different wavelengths, an AS can be used to distinguish compounds by analyzing the pattern of wavelengths absorbed by a given sample. Additionally, the amount of light absorbed is directly proportional to the concentration of absorbing compounds in that sample, so an AS can also be used to determine concentrations of compounds in the sample.|Cycle 1 day 1 at 0 hours and at 8 hours||||Absorbance 450 nm||Standard Deviation|Mean
2691920|NCT01306942|Secondary|Phosphorylated SRC (p-SRC) Protein Expression Change in Peripheral Blood Mononuclear Cells After 8 Hours of Treatment (Phase II)|Sequential peripheral blood mononuclear cells (PBMCs) on Cycle 1 Day 1 before treatment and 8 hours (h) after treatment (0h and 8h) were assessed to explore changes in the expression of p-SRC proteins measured by enzyme-linked immunosorbent assay (ELISA). For ELISA analyses, a duplicate of 100 µg of the extract was used to detect p-SRC (Tyr416). ELISA is a plate-based assay technique designed for detecting and quantifying proteins. The instrumentation used for protein signal-detection is an absorbance spectrophotometer (AS), which measures Absorbance (A). A is the quantity of light absorbed by a sample. As different compounds absorb light at different wavelengths, an AS can be used to distinguish compounds by analyzing the pattern of wavelengths absorbed by a given sample. Additionally, the amount of light absorbed is directly proportional to the concentration of absorbing compounds in that sample, so an AS can also be used to determine concentrations of compounds in the sample.|Cycle 1 day 1 at 0 hours and at 8 hours||||Absorbance 450 nm||Standard Deviation|Mean
2691921|NCT01306942|Secondary|Dasatinib Area Under the Plasma Concentration-time Curve (AUC) Value (Pharmacokinetics (PK) Phase I)|"To assess the influence of the concomitant administration of paclitaxel and trastuzumab on dasatinib PKs, we compared dasatinib exposures alone (first PK occasion: day 2 of cycle 1) or combined (second PK occasion: day 18 on cycle 1).~The area under the plasma concentration-time curve from time zero to 8 hours post dose (AUC0-8) were calculated in all treated patients, as the dasatinib plasmatic half-life is very short and concentrations at 24 hours post dose could only be quantified in some patients."|Cycle 1 day 2 and day 18|Two participant samples for cycle 1 day 18 could not be obtained.|||ng·h/mL||Standard Deviation|Mean
2693648|NCT01293123|Secondary|Neuropsychological Performance|Change in neuropsychological performance over 180 days|180 days|Insufficient enrollment for data analysis||||||
2691922|NCT01306942|Secondary|Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I)|"To assess the influence of the concomitant administration of paclitaxel and trastuzumab on dasatinib PKs, we compared dasatinib exposures alone (first PK occasion: day 2 of cycle 1) or combined (second PK occasion: day 18 on cycle 1).~The mean profiles of dasatinib plasma concentrations were determined by dose and PK occasion."|Cycle 1 day 2 and day 18|Two participant samples for cycle 1 day 18 could not be obtained.|||ng/mL||Standard Deviation|Mean
2691923|NCT01306942|Secondary|Response Duration (RD)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. RD is defined as the time from the date when the measurement criteria are met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the date of first observation of disease progression or death occurred. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an >=30% decrease in the sum of the longest diameter of target lesions. For responding patients not known to have died as of the data cut-off date and who do not have progression, RD will be censored at the date of last visit with adequate assessment. For responding patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to progression, RD will be censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.|Through study treatment, an average of 24 months||||months||95% Confidence Interval|Median
2691924|NCT01306942|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of the first dose to the first date of objectively determined progressive disease or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objectively-determined progressive disease, PFS will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS will be censored at the date of last objective progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy.|Through study treatment, an average of 24 months||||months||95% Confidence Interval|Median
2691925|NCT01306942|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy.|Through study treatment, an average of 24 months||||months||95% Confidence Interval|Median
2691926|NCT01306942|Secondary|To Evaluate the Clinical Benefit Rate (CBR)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CBR is defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) plus stable disease lasting at least 6 months out of the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Through study treatment, an average of 24 months||||Participants|||Count of Participants
2691927|NCT01306942|Secondary|The Number of Participants Who Experienced Adverse Events (AE)|Safety was assessed by standard clinical (blood pressure, pulse and body temperature, electrocardiogram (ECG), left ventricular ejection fraction (LVEF)) and laboratory tests (hematology: hemoglobin, platelet count, red blood cells (RBC), white blood cells (WBC) with differential (neutrophils) and absolute lymphocyte count, and serum chemistry: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, sodium, potassium, magnesium, phosphate and calcium). Adverse events grade were defined by the NCI CTCAE v 4.03.|Through study treatment, an average of 24 months||||Participants|||Count of Participants
2691928|NCT01306942|Primary|Objective Response Rate (ORR)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. ORR is defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) out of the patients who had measurable disease at baseline. Per RECIST, Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as an >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Through study treatment, an average of 24 months||||Participants|||Count of Participants
2691929|NCT01306942|Primary|Recommended Phase II Dose (RP2D) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I).|The RP2D was decided by the investigators taken into consideration the information obtained in the study and based on the MTD. To define the RP2D, information about toxicity observed during the full treatment were taken into consideration (relative dose intensity and toxicity observed).|Up to cycle 1||||mg|||Number
2691930|NCT01306942|Primary|Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I)|MTD is determined by testing increasing doses of dasatinib on dose escalation cohorts 3 to 6 patients per dose level. MTD reflects the highest dose tested in which a DLT is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels|Up to cycle 1||||mg|||Number
2691931|NCT01306942|Primary|Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I)|DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03), assessed as possibly, probably or definitively related to study drugs, occurring within the first cycle of study treatment: Need of any dose modification within the first cycle due to toxicity, grade 3 or 4 neutropenia complicated with fever ≥38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment related toxicity.|Up to cycle 1||||Participants|||Count of Participants
2691932|NCT01306890|Secondary|Survival|To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.|Every 3 months for a minimum of 3 years||||months||95% Confidence Interval|Median
2691933|NCT01306890|Primary|To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects|The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.|Every 3 months for a minimum of 3 years||||events per 100 patient years|||Number
2691934|NCT01306877|Secondary|Operative Room (OR) Time|Time of insertion of anoscope to time of anoscope removal after stapleline evaluation|Day 0||||minutes||Standard Deviation|Mean
2691935|NCT01306877|Secondary|Length of Stay|Length of hospital stay is defined as time of anoscope insertion until discharge|Day 0 time of discharge minus time of admission||||Hours||Standard Deviation|Mean
2691936|NCT01306877|Secondary|Location of the Staple Line|Distance of staple line to dentate line as measure by surgical ruler|Day 0||||mm||Standard Deviation|Mean
2691937|NCT01306877|Secondary|Overall Quality of Life - General Health Score|Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health|Day 0 minus 60, 1 week, 1 month, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
2691938|NCT01306877|Secondary|Post-Operative Pain (Analgesic Intake)|post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.|Day 0, 1 week, 2 week, 1 month, 3 month, 6 month||||participants|||Number
2691939|NCT01306877|Secondary|Post Operative Pain - (PI-NIRS)|"Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.~The data represented is the change in baseline score at the different timepoints."|Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180||||units on a scale||Standard Deviation|Mean
2691940|NCT01306877|Primary|Intraoperative Bleeding|Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.|Day 0 - time of surgery||||participants|||Number
2691941|NCT01306656|Secondary|Change in Urinary Calcium Level|This is designed to measure how the study treatment will affect urinary calcium level over time.|1 month, 3 months, 6 months|Data is provided for 6 out of the 7 participants in Group 1 due to that 1 participant became lost to follow-up and did not complete lab testing at Month 3 and 6.|||mg/day||Full Range|Mean
2691942|NCT01306656|Secondary|Trabecular Bone Density at the Forearm|Measured by high resolution peripheral quantitative computed tomography|6 months|Study enrollment did not reach the required number of subjects; the analysis results are not reliable nor have enough statistical power.|||percentage of change||Standard Deviation|Mean
2691943|NCT01306656|Secondary|Areal Bone Mineral Density of the Lumbar Spine|Measured by dual-energy x-ray absorptiometry (DEXA) scan|6 months|Study enrollment did not reach the required number of subjects; the analysis results are not reliable or have enough statistical power.|||percentage of change||Standard Deviation|Mean
2691944|NCT01306656|Primary|Serum Parathyroid Hormone (PTH) Level|This is designed to measure how many participants will achieve PTH > 65 pg/mL.|6 months|Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not available for analysis.||||||
2691945|NCT01306643|Secondary|Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
2691946|NCT01306643|Secondary|Changes in Concentration of Peripheral Blood Chemokines and Cytokines||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
2691947|NCT01306643|Secondary|Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
2691948|NCT01306643|Secondary|Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
2691949|NCT01306643|Primary|Clinical Response: Overall Response Rate|"Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.~Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.~CR was defined as the disappearance of all evidence of disease.~PR was defined the regression of measurable disease and no new sites."|Up to twelve 28-day cycles (maximum of 12 months)|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
2691950|NCT01306643|Primary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|30 days post last study treatment (up to 12 months)|Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.|||percentage of participants|||Number
2691951|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
2692048|NCT01305564|Primary|Clinical Success of Retrieval|Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.|24 months||||percentage of participants||95% Confidence Interval|Number
2691952|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
2691953|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
2691954|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
2691955|NCT01306617|Secondary|Resistance-Associated Variants and Phenotypic Resistance|Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented.|Day 1 to post-treatment week 48|Resistance analyses included all participants who receive at least one dose of study drug (intent-to-treat [ITT] population).|||participants|||Number
2691956|NCT01306617|Secondary|Time to Virologic Relapse Post-treatment|Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to post-treatment week 48|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||days||Standard Error|Mean
2691957|NCT01306617|Secondary|Time to Failure to Suppress or Rebound During Treatment|Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||days||Standard Error|Mean
2691958|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2691959|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2691960|NCT01306617|Secondary|Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2691961|NCT01306617|Secondary|Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2691962|NCT01306617|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2691963|NCT01306305|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population|||Subjects|||Number
2691964|NCT01306305|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP|||Fold (ratio)|||Number
2691965|NCT01306305|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP|||Number of subjects|||Number
2691966|NCT01306305|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population includes all subjects who received study vaccine|||Subjects|||Number
2691968|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline|All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (Qp [litres per minute]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: [(mean PAP-PCWP) divided by Qp] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.|Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).|||dyne*sec/cm^5||Standard Deviation|Mean
2691969|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).|||mmHg||Standard Deviation|Mean
2691970|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) >=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP <25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).|||mmHg||Standard Deviation|Mean
2691971|NCT01306253|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population|||Subjects|||Number
2691972|NCT01306253|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP|||Fold (ratio)|||Number
2691973|NCT01306253|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP|||Number of subjects|||Number
2691974|NCT01306253|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine|||Subjects|||Number
2691975|NCT01306253|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject per group lost to follow up|||Number of subjects|||Number
2691976|NCT01306214|Secondary|Change From Baseline in HbA1c After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)|||percentage of HbA1c||Standard Error|Least Squares Mean
2691977|NCT01306214|Secondary|Change From Baseline in Body Weight After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)|||kg||Standard Error|Least Squares Mean
2691978|NCT01306214|Secondary|Change From Baseline in Insulin Dose After 52 Weeks of Treatment|The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set-patients in FAS without important protocol violations leading to exclusion, completed minimum treatment of 357 days and did not prematurely discontinue. Values after start of antidiabetic rescue therapy (week 52 definition) were set to missing and last observation carried forward (LOCF-52) was used for imputation of missing values.|||IU/day||Standard Error|Least Squares Mean
2691979|NCT01306214|Primary|Change From Baseline in HbA1c After 18 Weeks of Treatment|The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.|Baseline and 18 weeks|The analysis was conducted on the full analysis set (FAS) of patients. Values after start of antidiabetic rescue therapy (week 18 definition) were set to missing and last observation carried forward (LOCF-18) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Least Squares Mean
2691980|NCT01306201|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation.||Overall average||||Breaths Per Minute (BrPM)||Standard Deviation|Mean
2693649|NCT01293123|Primary|Cerebrospinal Fluid HIV RNA Levels|Slope of decline of HIV RNA levels in CSF over time|180 days|Insufficient enrollment for data analysis||||||
2691981|NCT01306201|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.~The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average for 30 minutes||||Breaths Per Minute (BrPM)|||Number
2691982|NCT01306201|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.|Participants were monitored for average of 30 minutes|10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed|||BrPM (Breaths Per Minute)||Standard Deviation|Mean
2691983|NCT01306175|Secondary|Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2691984|NCT01306175|Primary|Digoxin: Maximum Measured Concentration (Cmax)|Maximum measured concentration of digoxin, per period.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2691985|NCT01306175|Primary|Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.|||ng-h/mL||Geometric Coefficient of Variation|Geometric Mean
2691986|NCT01306162|Secondary|Free Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of free dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2691987|NCT01306162|Secondary|Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691988|NCT01306162|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2691989|NCT01306162|Primary|Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|Pharmacokinetic (PK) set defined as all subjects randomised, treated and who provided evaluable data for at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691990|NCT01306058|Secondary|Percentage Signal Change in Response on Magnetic Resonance Imaging (MRI)|The perfusion of tumors was evaluated and analysis of normalized signal intensity in unenhanced and enhanced MRIs at each time point with calculation of measured percentage of signal change to reflect tumor vascularity. Signal change and signal intensity is defined as the Initial Area Under the Gd Curve measured over 60 seconds (IAUC60) and the Transport Constant (Ktrans) and the difference in these values relative to baseline.|Baseline and Cycle 1 Day 2 and Cycle 2 Day 1, an average of 12 weeks|This analysis was not done as magnetic resonance imaging (MRI) scans not performed as planned.||||||
2691991|NCT01306058|Secondary|Changes in Biomarker Cluster of Differentiation 105 (CD105)|Blood samples were collected and analyzed by the enzyme-linked immunosorbent assay (ELISA). Serum samples were measured using a validated ELISA with a lower limit of quantification (LLOQ) of 200 ng/ml. Soluble endoglin was only assessed in patient samples without detectable TRC105 concentrations.|Cycle 1 day 1, cycle 1 day 15, cycle 2 day 1, or end of study (eos), an average of 12 weeks|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||ng/ml||Inter-Quartile Range|Median
2692049|NCT01305564|Primary|Technical Success of Retrieval|Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.|24 months|The denominator of 124 is equal to the number of subjects that had a filter retrieval procedure (successful and unsuccessful retrievals). Subjects were not required to have a retrieval procedure.|||percentage of participants||95% Confidence Interval|Number
2691992|NCT01306058|Secondary|Changes in Biomarkers Vascular Endothelial Growth Factor (VEGF) and Placenta Growth Factor (PIGF)|Plasma biomarker tests were performed for VEGF and PIGF using assay plates from Meso-Scale Discovery according to the product manual. The concentrations of the cytokines were determined with recombinant standards. Changes in biomarkers were determined by a Wilcoxon signed rank test.|Cycle 1 day 1, cycle 1 day 15, cycle 2 day 1, or end of study, an average of 12 weeks|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||pg/ml||Inter-Quartile Range|Median
2691993|NCT01306058|Secondary|Area Under the Plasma Concentration|Mean peak TRC105 serum trough concentrations were plotted over time by dose level to assess accumulation. (e.g. drug absorption). The lower limit of quantification (LLOQ) is 200 ng/mL.|Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, and prior to start of TRC105 infusion|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Hr*ng/mL||Full Range|Mean
2691994|NCT01306058|Secondary|Number of Participants With Stable Disease, Partial Response, and Progressive Disease on Phase I and Phase II of the Clinical Trial|Response is defined as per the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. To be assigned a confirmed PR, changes in tumor measurements must be confirmed by repeat assessments that should be performed at least 4 weeks after the criteria for response are first met. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|Every 8 weeks, up to 180 days|7/27 participants were not evaluable (1 was not evaluable, 1 patient had dose limiting toxicity myocardial infarction, 1 could not tolerate sorafenib, 1 infusion reaction to TRC105 during first dose, 1 early progressive disease, 1 side effects, and 1 off due to severe skin toxicity).|||Participants|||Count of Participants
2691995|NCT01306058|Secondary|Percentage of Participants With Overall Survival (OS) at 6 and 12 Months|Percentage of participants last known to be alive at 6 and 12 months.|6 and 12 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
2691996|NCT01306058|Secondary|Median Overall Survival (OS)|OS was calculated from the on-study date until the date of death or the date the patient was last known to be alive. Probabilities were determined using the Kaplan-Meier method.|up to 2 years|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Months||95% Confidence Interval|Median
2691997|NCT01306058|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 3 and 6 Months|Percentage of participants who were progression free at 3 and 6 months. Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|3 and 6 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
2691998|NCT01306058|Secondary|Median Progression-free Survival (PFS)|PFS was calculated from the on-study date until date of progression, death, or an event that would render the patient inevaluable for further follow-up (liver dysfunction), or end of study. Probabilities were determined using the Kaplan-Meier method. Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|up to 6 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Months||95% Confidence Interval|Median
2691999|NCT01306058|Secondary|Treatment-emergent Adverse Events|Here are the number of treatment-emergent adverse events categorized by Any grade, Grade 3, Grade 4 and Grade 5 adverse events. Adverse events was assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. Grade 1 is mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 is moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (e.g. preparing meals, shopping for groceries or clothes). Grade 3 is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL (e.g. bathing, dressing and undressing). Grade 4 is life-threatening consequences; urgent intervention indicated. Grade 5 is death related to adverse event.|4 years and 10.5 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||treatment-emergent adverse events|||Number
2692000|NCT01306058|Secondary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT was assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. DLT criteria included treatment-related grade 3 non-hematological toxicities or grade 4 hematological toxicities occurring within the first 28 days of treatment. Grade 3 electrolyte toxicities to be corrected to Grade 1 or less within 24 hours will be considered dose limiting (proteinuria >3.5g/24 hour will be defined as a DLT). Drug-related Grade 4 hematological toxicity will be considered dose limiting. Toxicity requiring a dose reduction or a delay in treatment for >7 days will be considered dose limiting. Other Grade 3 or higher toxicity related to TRC105 will be considered dose limiting.|First 28 days of treatment (cycle 1)||||Participants|||Count of Participants
2693650|NCT01293084|Secondary|Percent Mucociliary Clearance at 90 Minutes||90 minutes|Data for participants that completed and received both 7% saline and 0.12% saline.|||percentage mucociliary clearance||Inter-Quartile Range|Median
2692001|NCT01306058|Secondary|Number of Participants With Serious and Non-serious Adverse Events by Common Terminology Criteria in Adverse Events (CTCAE)v4.0|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 years and 10.5 months||||Participants|||Count of Participants
2692002|NCT01306058|Secondary|Immunogenicity of TRC105 as Measured by Human Anti-mouse Antibody (HAMA) Formation|A 5mL blood sample will be collected to assess immunogenicity. Immunogenicity will be measured by the enzyme-linked immunosorbent assay (ELISA) and expressed in titres. The higher the titre, the higher the formation of HAMA antibody in the blood. A higher concentration of HAMA (higher titre result) is a negative finding. A higher level means the drug elimination is faster and the TRC 105 is then less effective. Lower level is 0-2 titre. Any value above 2 titre would be a positive HAMA result. The HAMA ( Human anti-mouse antibody) measurement at 28 days post treatment levels provides information as to the rate of drug elimination and effectiveness. Patients with 0 to < 2.0 titre. eliminates the TRC 105 slower and the drug may be more effective than patients who have a low(>2.0 titres) or high level of HAMA. Higher levels of HAMA reflect the TRC 105 elimination from the body faster and the drug potentially not as effective as negative HAMA titres.|Baseline and then 28 days following the end of the study treatment, approximately two years|9/20, 8/20, and 3/20 participants were evaluable for the noted time periods below.|||titres||95% Confidence Interval|Geometric Mean
2692003|NCT01306058|Secondary|Patients Who Developed Antidrug Antibodies|Patients who develop antidrug antibodies is measured by human anti-chimeric antibody (HACA) formation (e.g. immunogenicity of TRC105).|Cycle 1 Day 1, 28 days post end of study (up to 2 years)|11/27 were analyzed because only 11 patients were evaluable at the highest dose level given to patients.|||Participants|||Count of Participants
2692004|NCT01306058|Secondary|Overall Response Rate (ORR) as Determined by the European Association for the Study of the Liver (EASL)-Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall response (Complete Response (CR) + Partial Response (PR) was assessed by the European Association for the Study of the Liver (EASL)-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for target lesions and assessed by magnetic resonance imaging (MRI). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of target lesions.|2 years|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
2692005|NCT01306058|Secondary|Overall Response Rate (ORR) as Determined by the Standard Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall response (Complete Response (CR) + Partial Response (PR) was assessed by the Standard Response Evaluation Criteria in Solid Tumors (RECIST) criteria for target lesions and assessed by magnetic resonance imaging (MRI). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of target lesions.|2 years|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
2692006|NCT01306058|Primary|Phase II: Time to Progression (TTP) for the Combination of TR105 With Sorafenib in Hepatocellular Cancer (HCC)|TTP is the time between the first day of treatment to the day of disease progression. Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|2 years|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Months||95% Confidence Interval|Median
2692007|NCT01306058|Primary|Phase I: Maximum Tolerated Dose (MTD) of TRC105 When Given With Standard-dose Sorafenib for Hepatocellular Cancer (HCC)|MTD is the highest dose studied for which the incidence of DLT was less than 33%. DLT criteria included treatment-related grade 3 non-hematological toxicities or grade 4 hematological toxicities occurring within the first 28 days of treatment. Grade 3 electrolyte toxicities to be corrected to Grade 1 or less within 24 hours will be considered dose limiting (proteinuria >3.5g/24 hour will be defined as a DLT). Drug-related Grade 4 hematological toxicity will be considered dose limiting. Toxicity requiring a dose reduction or a delay in treatment for >7 days will be considered dose limiting. Other Grade 3 or higher toxicity related to TRC105 will be considered dose limiting.|Completed in the first 28 days of treatment (cycle 1)|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||mg/kg|||Number
2692008|NCT01306032|Secondary|Number of Participants With Deleterious Mutations in DNA Repair Genes|Gene expression profiling was performed in archival tumor tissue for a panel of 211 genes using deoxyribonucleic acid (DNA) array to determine deleterious mutations (i.e. nonsynonymous mutations at coding regions) of genes. Sequences were mapped to human genome reference hg19. Variants were identified with VarScan, annotated with AVIA, and masked to the exonic or exonic:splicing regions of the 211 interrogated DNA repair genes, with nonsynonymous/frameshift/stop-gain/stop-loss variants that have a population frequency of 1% or less in either 1000G (2014_04) or the ExomeSequencingProject (ESP6500si_all) with a minimum variant frequency of 10% and at least 20 reads. Lastly, variants were manually inspected for known platform and mapping errors.|Optional tumor biopsies were performed prior to start of treatment (baseline) and 6 months|Patients with sufficient tumor content in archival tissue (defined as ≥70% tumor after macrodissection) were analyzed for genetic alterations in DNA repair genes by whole-exome sequencing.|||Participants|||Count of Participants
2692009|NCT01306032|Secondary|Change in ϓH2AX- Positive Circulating Tumor Cells (CTCs) in Whole Blood|Number of CTCs (evaluable defined as ≥ 6 CTCs) were measured in whole blood during the course of treatment to determine drug-induced deoxyribonucleic acid damage in tumor cells.|At baseline (t=0h) and 24h post drug administration (t=24h)|Patients with sufficient CTC counts (defined as ≥6 total CTCs) pre- and post-drug administration were analyzed.|||ϓH2AX- Positive CTCs||Full Range|Mean
2692010|NCT01306032|Secondary|Change in Poly-ADP Ribose (PAR) Concentration Levels From Baseline|PAR levels (in pg/μg protein) were assessed in peripheral blood mononuclear cells (PBMCs) by immunoassay to assess poly (ADP-ribose) polymerase (PARP) activity. Significant inhibition of PARP activity is associated with 50% or greater reduction in PAR levels.|At baseline (t=0h) and 4h post drug administration (t=4h)|Patients with PBMCs data pre- and post-drug administration, and with PAR levels above the lower limit of quantitation (LLOQ) of 23 pg/μg protein were analyzed.|||pg/μg protein||Full Range|Mean
2692011|NCT01306032|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 30 days following the last dose of study drug.||||Participants|||Count of Participants
2692012|NCT01306032|Primary|Progression Free Survival|Time to progression for each participant for the initial intervention.|Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.|Participants evaluable for response.|||Cycles of therapy||Full Range|Median
2692013|NCT01306032|Primary|Percentage of Participants With an Overall Response Rate|Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.|Participants evaluable for response.|||percentage of participants|||Number
2692014|NCT01305941|Secondary|Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life|The FACT-B is a 10-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with breast cancer. Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-B subscale range from 0 to 40 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.|9 weeks|Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint|||units on a scale||Inter-Quartile Range|Median
2692015|NCT01305941|Secondary|Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life|The FACT-Br is a 23-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with brain tumors . Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-Br subscale range from 0 to 92 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.|9 weeks|Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint|||units on a scale||Inter-Quartile Range|Median
2692016|NCT01305941|Secondary|Overall Survival|Overall survival (OS) after administration of everolimus in combination with trastuzumab and vinorelbine|3 years||||years||95% Confidence Interval|Median
2692017|NCT01305941|Secondary|Extracranial Time to Progression|"To evaluate the extracranial time to progression as determined by RECIST 1.1 criteria after administration of everolimus in combination with trastuzumab and vinorelbine.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Seven subjects were not evaluable for extra-cranial response due to no follow-up disease assessments due to poor clinical status; 12 subjects were excluded since they did not have extra-cranial disease at baseline; 1 subject was non compliant for follow-up scans; and 1 subject was excluded due to intracranial progression prior to extracranial.|||months||Full Range|Median
2692018|NCT01305941|Secondary|Extracranial Response|"Extracranial response was measured using RECIST 1.1 criteria and defined as the number of subjects achieving CR or PR.~Complete Response (CR) - Disappearance of all target and nontarget lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.~Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Seven subjects were not evaluable for extra-cranial response because there was no follow-up disease assessment done due to poor clinical status of subjects. An additional 12 subjects were excluded since they did not have extra-cranial disease at baseline and one additional subject was non compliant for follow-up scans.|||Participants|||Count of Participants
2692019|NCT01305941|Secondary|Time to Intracranial Progression.|"Time to intracranial progression after administration of everolimus in combination with trastuzumab and vinorelbine as defined via modified RECIST criteria.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years||||months||95% Confidence Interval|Median
2692020|NCT01305941|Secondary|Toxicity|"Grade 3 or higher toxicities of interest are reported. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.~The NCI CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|24 weeks||||Participants|||Count of Participants
2692021|NCT01305941|Secondary|Intracranial Response Rate- MacDonald Criteria|"Intracranial tumor lesions were evaluated via gadolinium-enhanced brain MRI using the MacDonald criteria. Measurable disease is defined as at least 1 measurable brain lesion accurately measured in at least 2 dimensions (longest diameter) as ≥5.0 mm. Tumor size is the product of the 2 longest bi-dimensional lines.~Complete Response (CR)- Disappearance of all tumor on consecutive CT or MRI scans at least 1 month apart, off steroids for treatment of neurological symptoms, and neurologically stable or improved.~Partial Response (PR)- ≥50% reduction in size of tumor on consecutive CT or MRI scans at least 1 month part, steroids stable or reduced, and neurologically stable or improved.~Progressive Disease (PD)- ≥25% increase in size of tumor or any new tumor on CT or MRI scans, or neurologically worse, and steroids stable or increased due to neurologic symptoms.~Stable Disease (SD)- all other situations Overall Response Rate (ORR) is the sum of partial responses (PRs) and CRs."|3 years|Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects|||Participants|||Count of Participants
2692022|NCT01305941|Primary|Intracranial Objective Response Rate- Modified RECIST Criteria|"response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria.~Complete Response (CR) - Disappearance of all target and nontarget lesions~Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.~Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects|||Participants|||Count of Participants
2692023|NCT01305811|Other Pre-specified|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|2 months||||units on a scale||Standard Deviation|Mean
2692024|NCT01305811|Primary|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|6 months||||units on a scale||95% Confidence Interval|Mean
2692025|NCT01305772|Secondary|Nine (9) Month Overall Survival (OS)|Overall survival (OS) was defined as from the time of enrollment to the date of death resulting from any cause. Time as censored at the date of the last follow-up visit for subjects who were still alive. The 9-month OS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are alive.|9 months||||percentage of treated patients surviving||95% Confidence Interval|Number
2692026|NCT01305772|Secondary|Nine (9) Month Progression Free Survival (PFS)|"Nine month progression-free survival (PFS) was defined from the time from enrollment to the first date of disease progression or death as a result of any cause. Progression was defined in the same manner as in RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5mm (the appearance of one or more new lesions is also considered progression).~Time was censored at the date of the last follow-up visit for subjects who were still alive and have not progressed. The 9 month PFS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are disease free or alive."|9 months||||percentage of treated patients||95% Confidence Interval|Number
2692027|NCT01305772|Primary|Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy|"The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined in the same manner as in RECIST 1.1.~No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants."|Baseline to 2 years|No results will be reported for the primary outcome measure as only 2 of the 6 subjects had tissue collected after the first dose of panitumumab due to safety risk to the subject.||||||
2692046|NCT01305564|Secondary|Rate of New or Worsening Deep Vein Thrombosis|Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit.|6 months|The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.|||percentage of participants||95% Confidence Interval|Number
2692028|NCT01305655|Primary|Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.|"Glucarpidase was used in case of predefined toxic MTX values at defined time points and/or in combination with decreased renal function.~A total of 47 patients of the 1286 ALL-patients included in the protocol (3.7 %) were treated with Glucarpidase."|6 years 6 months||||participants|||Number
2692029|NCT01305577|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
2692030|NCT01305577|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
2692031|NCT01305577|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:~How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
2692032|NCT01305577|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
2692033|NCT01305577|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||percentage of participants|||Number
2692034|NCT01305577|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||mm||Standard Deviation|Mean
2692035|NCT01305577|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
2692036|NCT01305577|Secondary|Change From Baseline in CR-SMFRS Scores|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
2692037|NCT01305577|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.~The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
2692038|NCT01305577|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
2692039|NCT01305577|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population, which consisted of all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants|||Number
2692040|NCT01305564|Secondary|Filter Penetration >3mm at Retrieval||Pre-retrieval|The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.|||percentage of participants||95% Confidence Interval|Number
2692041|NCT01305564|Secondary|Filter Penetration >3mm at Placement||Post-placement|Penetration at Placement was measured immediately post-placement but prior to retrieval.|||percentage of participants||95% Confidence Interval|Number
2692042|NCT01305564|Secondary|Filter Tilt at Retrieval|Rate of filter indwell complications of: tilt >15°|Pre-retrieval imaging|All patients undergoing a retrieval procedure.|||percentage of participants||95% Confidence Interval|Number
2692043|NCT01305564|Secondary|Filter Tilt at Placement|Rate of filter indwell complications of: tilt >15°|Post-placement imaging|Tilt was measured post-placement with vena cavagram.|||percentage of participants||95% Confidence Interval|Number
2692050|NCT01305564|Primary|Clinical Success of Placement|Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.|6 months|The denominator of 189 is equal to all of the subjects that completed the 6 month visit, had their filter retrieved, or experienced a component of the clinical success of placement endpoint regardless of follow-up duration.|||percentage of participants||95% Confidence Interval|Number
2692051|NCT01305564|Primary|Technical Success of Placement|Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.|6 months||||percentage of participants||95% Confidence Interval|Number
2692052|NCT01305473|Post-Hoc|Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias|A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater|This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure.|||participants|||Number
2692053|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh.|A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure.|||participants|||Number
2692054|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh.|A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure.|||participants|||Number
2692055|NCT01305473|Secondary|Recovery Time Associated With Hernias Repaired With Sepramesh.|Recovery time will be defined as the time it took for the subject to return to work.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed.||||||
2692056|NCT01305473|Secondary|Procedural Time for Sepramesh Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|Day 0|All enrolled subjects were included in the analysis.|||minutes||Standard Deviation|Mean
2692057|NCT01305473|Secondary|Complications in Subjects With Hernias Repaired With Sepramesh.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.|||participants|||Number
2692058|NCT01305473|Primary|Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.|A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.|||participants|||Number
2692059|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692060|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692083|NCT01305356|Secondary|Fusion Site Pain|Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).|Baseline, 9, 12, 16, 24, 36, and 52 weeks|Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.|||units on a scale||Standard Error|Mean
2692102|NCT01305213|Secondary|Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0|Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.|Up to 5 years|All eligible and treated patients|||Participants|||Count of Participants
2692061|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692062|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692063|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692064|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692065|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692066|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692067|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2693651|NCT01293084|Primary|Percent Mucociliary Clearance at 60 Minutes||60 minutes|Participants that completed received both 7% saline and 0.12% saline over the duration of the study|||percentage mucociliary clearance||Inter-Quartile Range|Median
2692068|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692069|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692070|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2692071|NCT01305408|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2692072|NCT01305408|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2692073|NCT01305408|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2692074|NCT01305408|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.|||participants|||Number
2692084|NCT01305356|Secondary|AOFAS Hindfoot and Ankle Score|Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.|Baseline, 9, 12, 16, 24, 36, and 52 weeks|Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.|||units on a scale||Standard Error|Mean
2693688|NCT01292629|Secondary|Complications and Adverse Events|Number of Participants with Complications or Adverse Events|4 to 6 months||||participants|||Number
2692075|NCT01305408|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2692076|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2692077|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2692078|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2692079|NCT01305408|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
2692080|NCT01305408|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
2692081|NCT01305408|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2692082|NCT01305356|Secondary|SF-12 Physical Component Score|The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.|Baseline, 9, 12, 16, 24, 36, and 52 weeks|Analysis conducted on patients at Baseline, 12, 16, 24, 36, and 52 weeks time points.|||units on a scale||Standard Error|Mean
2692085|NCT01305356|Secondary|Foot Function Index (FFI)|The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.|Baseline, 9, 12, 16, 24, 36, and 52 weeks|Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.|||units on a scale||Standard Error|Mean
2692086|NCT01305356|Primary|Pain on Weight Bearing|Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).|Baseline, 9, 12, 16, 24, 36, and 52 weeks|Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.|||units on a scale||Standard Error|Mean
2692087|NCT01305265|Primary|Incidence of Tracheopharyngeal Symptoms||within 2 hours after extubation||||participants|||Number
2692088|NCT01305252|Secondary|B-type Natriuretic Peptide (BNP)|B-type Natriuretic peptide measures the percent change from baseline.|Baseline and 24 weeks||||percent change||Standard Deviation|Mean
2692089|NCT01305252|Secondary|Change in NYHA/WHO Class|"At 48 week,WHO/NYHA functional class was assessed for change in WHO/NYHA functional class.Change NYHA is measured as decrease or increase in NYHA class in the subjects compared with baseline.~NYHA /WHO functional class is described below:~NYHA functional class I:no symptoms and no limitation in ordinary physical activity NYHA functional class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA functional class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity NYHA functional class IV:Severe limitations. Experiences symptoms even while at rest A higher functional class represent worse symptoms."|Baseline and 48 week||||participants|||Number
2692090|NCT01305252|Secondary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|Change from baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|Baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
2692091|NCT01305252|Secondary|6 Minute Walk Distance|Change in 6MWD during 24 week period compared between Tada and Tada+iTre.|Baseline and 24 weeks||||meters||Inter-Quartile Range|Mean
2692092|NCT01305252|Primary|Change in Right Ventricular Ejection Fraction|Effect of dual-upfront therapies versus mono-therapy on percent change of right ventricular function assesed by cardiac MRI (cMRI) at 24 weeks compared with the baseline.|Basline and 24 weeks||||percent change||Inter-Quartile Range|Mean
2692093|NCT01305239|Secondary|Event-free Survival|Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 * 12.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|ITT population = all participants who received at least 1 dose of study drug and had at least 1 follow-up questionnaire completed. N = number of participants with analyzable (non-missing) data.|||months||95% Confidence Interval|Mean
2692094|NCT01305239|Secondary|Duration of Treatment|Total duration of adjuvant hormonal therapy with exemestane.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set; N = number of participants with analyzable (non-missing) data. For 2 participants lost to follow-up, the duration of exemestane was calculated until the date of lost to follow-up.|||months||Standard Deviation|Mean
2692095|NCT01305239|Secondary|Percentage of Participants Who Were Compliant With Treatment|Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. Information on compliance was not available for subjects who did not have a follow-up visit. N = number of participants with analyzable data.|||percentage of participants||95% Confidence Interval|Number
2692096|NCT01305239|Secondary|Reasons for Discontinuation of Aromasin Therapy||Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane.|||participants|||Number
2692097|NCT01305239|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set: all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2692098|NCT01305213|Secondary|Response by CA-125|The effects of treatment on the proportion responding by CA125 will be examined.|Up to 5 years||||Percentage of Participants||95% Confidence Interval|Number
2692099|NCT01305213|Secondary|Overall Survival (OS)|Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.|Up to 5 years||||months||90% Confidence Interval|Median
2692100|NCT01305213|Secondary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.0|for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years|Patients with measurable disease|||percentage of participants||90% Confidence Interval|Number
2692101|NCT01305213|Secondary|Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS)|Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.|Up to 5 years||||months||95% Confidence Interval|Median
2693723|NCT01292304|Primary|Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)|This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)|12 weeks of study drug||||participants|||Number
2692103|NCT01305213|Primary|Progression-free Survival (PFS)|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years|All intent to treat patients|||months||95% Confidence Interval|Median
2692104|NCT01305200|Other Pre-specified|Ancillary Validation Study of ChIMES||Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Analysis is not performed at this time due to no available funding and no human resource allocated to this study.||||||
2692105|NCT01305200|Secondary|Severity of Mucositis|Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation|Evaluable patients defined as patients with ≥11 daily WHO assessments.|||units on a scale * day||Standard Deviation|Mean
2692106|NCT01305200|Secondary|Incidence of Invasive Bacterial Infections|Invasive Bacterial Infection = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||percentage of participants|||Number
2692107|NCT01305200|Secondary|Incidence of Febrile Neutropenia|Fever and Neutropenia = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||percentage of participants|||Number
2692108|NCT01305200|Secondary|Duration of Total Parenteral Nutrition (TPN) Administration.|Mean days of total parenteral nutrition (TPN) administration.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||Number of days||Standard Deviation|Mean
2692109|NCT01305200|Secondary|Incidence of Total Parenteral Nutrition (TPN) Administration.|Total Parenteral Nutrition = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||percentage of participants|||Number
2692110|NCT01305200|Secondary|Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).|Morphine equivalent dose in mg/kg/day|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||mg/kg/day of opioid analgesics||Full Range|Median
2692111|NCT01305200|Secondary|Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).|Mean days of parenteral opioid analgesic use.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||Days||Standard Deviation|Mean
2692112|NCT01305200|Secondary|Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).|Opioid Administration = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II)|||percentage of participants|||Number
2692113|NCT01305200|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation|Evaluable patients defined as patients with ≥11 daily WHO assessments.|||units on a scale * day||Standard Deviation|Mean
2692114|NCT01305200|Secondary|Incidence of Severe Oral Mucositis|Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Evaluable patients defined as patients with >= 11 daily WHO assessments.|||percent of patients|||Number
2692115|NCT01305200|Primary|Duration of Severe Oral Mucositis (WHO Grade 3 or 4)|Mean days of severe (WHO Grade 3 or 4) Mucositis.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Evaluable patients defined as patients with >= 11 daily WHO assessments.|||Number of days||Standard Deviation|Mean
2692116|NCT01305044|Primary|Satisfaction With the Randomized Controlled Trial|The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.|||units on a scale||Inter-Quartile Range|Median
2692117|NCT01305044|Secondary|Inflammatory Cytokines|Fasting blood samples were collected in the morning for inflammatory cytokines. Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw. The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.|13-weeks||||pg/ml||Inter-Quartile Range|Median
2692118|NCT01305044|Secondary|Cortisol Area-Under-Curve (AUC)|Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion. Cortisol was measured in nmol/L. Cortisol AUC was calculated using the five timepoints with the trapezoid rule. The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means. Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.|13-weeks||||nmol*hr/L||Standard Error|Mean
2692119|NCT01305044|Secondary|Blood Pressure|Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.|13-weeks|Please refer to power calculation detailed in Primary Outcome Measure.|||mm Hg||Standard Error|Mean
2692120|NCT01305044|Secondary|Five-Facet Mindfulness Questionnaire|The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity). These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35). Higher scores indicate more mindfulness. The Total Score ranges from 39-195, with higher scores indicating more mindfulness.|13-weeks||||units on a scale||Inter-Quartile Range|Median
2692121|NCT01305044|Secondary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.|13-weeks||||units on a scale||Inter-Quartile Range|Median
2692122|NCT01305044|Secondary|Impact of Events Scale|The Impact of Event Scale assesses cancer-specific distress. Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact. It has a total score and two subscales (avoidance & intrusion). The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales. The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40. The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.|13-weeks||||units on a scale||Inter-Quartile Range|Median
2692123|NCT01305044|Secondary|Perceived Stress Scale|The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.|13 weeks||||units on a scale||Inter-Quartile Range|Median
2692124|NCT01305044|Secondary|Health-Related Quality of Life (Short Form (SF)-36v1)|SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100. Higher scores indicate better quality of life.|13 weeks|Please refer to power calculation detailed in Primary Outcome Measure.|||units on a scale||Standard Error|Mean
2692125|NCT01305044|Primary|Retention Rates and Class Attendance|The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.|||percentage of participants|||Number
2692126|NCT01304966|Secondary|Cotreta-Derkay Score|"We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes~Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.~Coltera-Derkay method of staging :~Clinical score:~Voice: Normal - 0, Abnormal - 1, Aphonia - 2~Stridor: Absent - 0, Present on activity - 1, Present at rest - 2~Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.~Anatomical score:~For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.~Total score = Anatomical score + Total clinical score"|12 months||||score||Standard Deviation|Mean
2692127|NCT01304966|Primary|Human Papillomavirus Genotypes|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy|12 months|We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.|||participants|||Number
2692128|NCT01304940|Primary|Prepulse Inhibition|"To calculate prepulse inhibition (PPI), first an O-EMG response score (O-EMG-R) for each trial was calculated. O-EMGR was measured in microvolts and each value was subjected to a square root transformation. For each participant, the mean O-EMG-R scores were calculated for both startle alone and prepulse + startle trials across the entire session. PPI is a ratio and was calculated by the formula below:~PPI=(mean OEMG-R score on prepulse+startle trials-mean OEMG-R on Startle alone trials)/mean OEMG-R on startle alone trials.~A negative value on this PPI ratio is indicative of greater prepulse inhibition.~Means and SEs below reflect estimated means and SEs for the PTSD group and trauma control group from the ANOVA conducted with menstrual phase and the PTSD group X menstrual phase interaction included in the model."|This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.|all participants with valid psychophys data analyzed|||proportion of change in OEMGR response||Standard Error|Mean
2692129|NCT01304706|Primary|Number of Participants With Adverse Events|This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.|12 months||||participants|||Number
2692130|NCT01304693|Secondary|Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria|Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.|Time to event, up to Month 6|ITT: All patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit.|||Days||Inter-Quartile Range|Median
2692131|NCT01304693|Primary|Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)|CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.|Baseline, Month 1|This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT). Efficacy data from visits occurring after standard of care (SoC) were censored and replaced based on LOCF,i.e. by the data observed at the time of the SoC decision.|||microns||Standard Deviation|Mean
2692132|NCT01304641|Secondary|Percentage of Participants Who Adhered to Index Therapy|Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Percentage of participants|||Number
2692133|NCT01304641|Secondary|Length of Post-index Period|Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009).|Index date (baseline) up to end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Days||Standard Deviation|Mean
2692134|NCT01304641|Secondary|Number of Participants Per Dose|Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg).|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Participants|||Number
2700988|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2692135|NCT01304641|Secondary|Mean Dose|The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||mg||Standard Deviation|Mean
2692136|NCT01304641|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)||At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2692137|NCT01304641|Primary|Hazard Ratio for First Cardiovascular (CV) Event|Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Participants|||Number
2692138|NCT01304641|Primary|Number of Participants With Post-index Cardiovascular (CV) Events|CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Participants|||Number
2692139|NCT01304589|Secondary|24-hour Vulvar Pain|"0 equals no vulvar pain within the last 24 hours to 10 equals worse imaginable vulvar pain within the last 24 hours. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were randomized to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes all 18 eligible subjects who completed all of the study visits.|||units on a scale||Standard Deviation|Mean
2692140|NCT01304589|Secondary|Coital Pain|"0 equals no pain with intercourse to 10 equals worse imaginable pain with intercourse. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were assigned to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes the 18 eligible subjects who completed all of the study visits.|||units on a scale||Standard Deviation|Mean
2692141|NCT01304589|Secondary|Tampon Pain|"0 equals no pain with tampon insertion to 10 equals worse pain imaginable with tampon insertion. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were eligible and received study medication. Analysis population includes all 22 eligible subjects.|||units on a scale||Standard Deviation|Mean
2692142|NCT01304589|Primary|Pain Rating Index|"The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. 0 equals no pain to 45 equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were eligible and received study medication. Analysis population included all 22 eligible subjects.|||units on a scale||Standard Deviation|Mean
2692143|NCT01304498|Secondary|Percentage of Participants With One or More Serious Adverse Events|A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2692144|NCT01304498|Secondary|Percentage of Participants With Maximum Oral Temperature ≥37.8°C|The percentage of participants with maximum oral temperature ≥37.8°C was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2692145|NCT01304498|Secondary|Percentage of Participants With One or More Systemic Adverse Events|The percentage of participants with one or more systemic adverse events was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2692146|NCT01304498|Secondary|Percentage of Participants With One or More Injection-site Adverse Reactions|The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.|Up to 5 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2692147|NCT01304498|Secondary|Percentage of Participants With One or More Adverse Events|An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2692148|NCT01304498|Secondary|Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||Percentage of participants||95% Confidence Interval|Number
2692163|NCT01304316|Primary|Half Life of Oxymetazoline|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 7 subjects in the 0.3 mg dose group and 0.6 mg dose group had sufficient concentration levels to calculate the half life.|||h||Standard Deviation|Mean
2692149|NCT01304498|Secondary|GMTs to HPV Types 6 and 11|Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
2692150|NCT01304498|Primary|Geometric Mean Titers (GMTs) to HPV Types 16 and 18|Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
2692151|NCT01304329|Secondary|Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2692152|NCT01304329|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2692153|NCT01304329|Primary|Simvastatin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2692154|NCT01304329|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values"|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2692155|NCT01304329|Primary|Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin.~The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2692156|NCT01304329|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2692157|NCT01304316|Secondary|Pulse Rate Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||bpm||Standard Deviation|Mean
2692158|NCT01304316|Secondary|Systolic BP Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||mmHg||Standard Deviation|Mean
2692159|NCT01304316|Secondary|Diastolic BP Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||mmHg||Standard Deviation|Mean
2692160|NCT01304316|Secondary|Pulse Oximetry Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||% oxygen||Standard Deviation|Mean
2692161|NCT01304316|Primary|Half Life of PBBA|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 8 subjects in the standard dose group and 11 subjects in the high dose group had sufficient concentration levels to calculate Cmax.|||h||Standard Deviation|Mean
2692162|NCT01304316|Primary|Half Life of Tetracaine|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|An insufficient number of tetracaine plasma concentrations existed in each subject to determine a half life for tetracaine||||||
2692164|NCT01304316|Primary|Cmax of PBBA|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||ng/mL||Standard Deviation|Mean
2692165|NCT01304316|Primary|Cmax of Tetracaine|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 4 subjects in the 18 mg dose group and 7 subjects in the 36 mg dose group had sufficient concentration levels to calculate Cmax.|||ng/mL||Standard Deviation|Mean
2692166|NCT01304316|Primary|Cmax of Oxymetazoline|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 11 subjects in the 0.3 mg dose group had sufficient concentration levels to calculate Cmax.|||ng/mL||Standard Deviation|Mean
2692167|NCT01304277|Secondary|Overall Summary of TEAEs by Treatment (Replagal RB and Replagal AF)|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status, concomitant medication, vital signs and ECG.|Week 2 to EOS||||participants|||Number
2692168|NCT01304277|Secondary|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status (in Serum) at End of Study||EOS||||participants|||Number
2692169|NCT01304277|Secondary|Dose-normalized Maximum Serum Concentration (Cmax/Dose)||Week 0 to Week 14||||Ratio||90% Confidence Interval|Geometric Mean
2692170|NCT01304277|Secondary|Dose-normalized AUC Extrapolated to Infinity (AUC∞/Dose)||Week 0 to Week 14||||Ratio||90% Confidence Interval|Geometric Mean
2692171|NCT01304277|Secondary|Dose-normalized Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast/Dose)||Week 0 to Week 14||||Ratio||90% Confidence Interval|Geometric Mean
2692172|NCT01304277|Secondary|Change From Baseline to Week 16 (EOS) in Plasma Gb3 Levels||Baseline to EOS||||(nmol/mL)||Standard Deviation|Mean
2692173|NCT01304277|Primary|Change From Baseline to Week 16 (EOS) in Urine Gb3 Levels||Baseline to EOS||||(nmol/g creatinine)||Standard Deviation|Mean
2692174|NCT01304238|Secondary|Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II|Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
2692175|NCT01304238|Secondary|Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II|Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
2692176|NCT01304238|Secondary|Number of Participants Who Underwent Amputation After the Occurrence of HIT II|Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
2692177|NCT01304238|Secondary|Number of Participants With Fatal Complications After the Occurrence of HIT II|Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
2692178|NCT01304238|Secondary|Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II|Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
2692179|NCT01304238|Primary|Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II|Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
2692180|NCT01304147|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.|2 weeks|Number of events, more detailed in adverse event section|||events|||Number
2692194|NCT01303939|Secondary|Relative Volumes|Relative volume is calculated by dividing the absolute volume of inferior occipital gyrus L (a location in the brain structure) by that individual's total brain volume.|2 hours||||cubic millimeters (mm3)||Standard Deviation|Mean
2692181|NCT01304147|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration~10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points."|24 hours|20 patients randomized and 18 completed both treatment periods|||participants|||Number
2692182|NCT01304082|Secondary|Rank-transformed Pain Score Upon Needle Stick.|"Pain score upon needle stick:~The pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable)."|1 minute after each injection||||rank||95% Confidence Interval|Least Squares Mean
2692183|NCT01304082|Secondary|Rank-transformed Time (Seconds) Until Anesthesia|Rank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus.|0-180 seconds after each injection||||rank||95% Confidence Interval|Least Squares Mean
2692184|NCT01304082|Secondary|Rank-transformed Time (Seconds) Until Hypoesthesia|Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus|0-180 seconds after each injection.||||rank||95% Confidence Interval|Least Squares Mean
2692185|NCT01304082|Primary|Rank-transformed Pain Score|"Pain score upon injection of local anesthetic:~the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable)."|immediate, upon injection of each solution||||rank||95% Confidence Interval|Least Squares Mean
2692186|NCT01303965|Secondary|Phase II - Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of three consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) through 1 year post-transplant|All patients who received treatment and who achieved platelet recovery/engraftment of platelets|||days||95% Confidence Interval|Median
2692187|NCT01303965|Secondary|Phase II - Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) through 1 year post transplant|All patients who received treatment and survived at least 14 days after transplant|||days||95% Confidence Interval|Median
2692188|NCT01303965|Secondary|Phase II - Percent of Patients With Treatment-related Deaths at 1 Year|Percent of patients and the 95% Binomial Confidence interval who had treatment-related deaths by 1 year for patients in Phase II.|Transplant (Day 0) through 1 year post-transplant|All patients who received treatment and were followed after transplant|||percentage of participants||95% Confidence Interval|Number
2692189|NCT01303965|Secondary|Phase II - Percent of Patients With Treatment-related Deaths at 100 Days|Percent of patients and the 95% Binomial Confidence interval who had treatment-related deaths by 100 days for patients in Phase II.|100 days post transplant|All patients who received treatment and were followed after transplant|||percentage of participants||95% Confidence Interval|Number
2692190|NCT01303965|Secondary|Phase II - Percent of Patients With Chronic Graft Versus Host Disease (GvHD)|Percent of patients and the 95% Binomial Confidence interval who had any chronic GvHD reported based on Filipovich et al. consensus document (BB&MT 2005) and Akpek et al. chronic GvHD grading system (Blood 2003) for patients in Phase II.|Transplant (Day 0) through 1 year post-transplant|All patients who received treatment and were followed after transplant|||percentage of participants||95% Confidence Interval|Number
2692191|NCT01303965|Secondary|Phase II - Percent of Patients With Acute Graft Versus Host Disease (GvHD)|"Percent of patients and the 95% Binomial Confidence interval who had any stage I-IV acute GvHD based on the modified Keystone Grading Scale for skin, liver and gastrointestinal symptoms for patients in Phase II. Zero means no acute GvHD was reported, and higher stages are worse outcomes (range of 0-4).~For skin: 0=no rash; 1=erthematous macular rash over <25% body surface; 2=over 25-50% of body surface; 4=bullae, exfoliation ulcerative dermatitis.~For liver (bilirubin (mg/dL)): 0= <2.0; 1= 2-<2.9; 3= 3-<5.9; 4= >=15 . For gut changes (diarrhea[ml/day]): 0=none; 1= >500-1000; 2= >1000-1500; 3= >1500; 4=severe abdominal pain with or without ileus.~Overall grade 0: Skin=0; liver=0; gut changes=0. Overall grade 1: Skin with 1 or 2; liver=0; gut changes=0. Overall grade 2: Skin with 1, 2, or 3; liver=1; gut changes=1. Overall grade 3: Skin with 2 or 3; liver with 2 or 3; gut changes with 2 or 3. Overall grade 4: Patients with grade 4 toxicity in any organ system."|Day 0 through 1 year post transplantation|All patients who received treatment and were followed after transplant|||percentage of participants||95% Confidence Interval|Number
2692192|NCT01303965|Primary|Phase II: Percent of Patients Alive and Free of Progression at 12 Months Following Transplant|Percent of patients and the 95% Binomial Confidence interval who were alive and free of progression at 12 months following transplant for the patients in Phase II. Progression will be based on International Myeloma Working Group criteria where patients may meet any one of the following criteria - increase of 25% or more in serum or urine M-protein from baseline, Serum M-protein and/or the absolute increase must be >=0.5 g/dl, Urine M-protein and/or absolute increase must be >=200 mg/24 hours, development of new bone lesions or soft tissue plasmacyomas or definite increase in the size of existing bone lesions or soft tissue plasmacyomas, or development of hypercalcemia (corrected serum Ca++>11.5 mg/dl) that can be attributed solely to plasma cell proliferative disease.|Transplant (Day 0) through 1 year post-transplant|All patients who received treatment and were followed after transplant.|||percentage of participants||95% Confidence Interval|Number
2692193|NCT01303965|Primary|Phase I: Number of Participants With Dose Limiting Toxicity|The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sirolimus, tacrolimus and lenalidomid. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.|28 days|All patients assigned to Phase I and received treatment medication.|||Participants|||Count of Participants
2692196|NCT01303861|Secondary|Continuous Cigarette Abstinence From Quit Date|Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).|From Quit date to end of treatment (week 11)|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.|||participants||95% Confidence Interval|Number
2692197|NCT01303861|Secondary|Seven Day Point Abstinence From Cigarette Smoking|Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.|Six months post quit date|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.|||participants||95% Confidence Interval|Number
2692198|NCT01303861|Primary|Four-week Continuous Abstinence From Cigarette Smoking|The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.|Study week 8 thru week 11|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.|||percentage of participants||95% Confidence Interval|Number
2692199|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline|Patients completed neurocognitive testing at each QoL measurement assessment. Neurocognitive function was measured via a computerized neurocognitive test battery called CNS Vital Signs. The battery consists of 7 tests that assess verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and continuous performance. The battery provides scores over 9 domains with higher scores indicating better performance. Scores were normalized to a standard score mean of 100 and standard deviation of 15 using a normative sample. The mean difference in score in each domain between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in mean score, while a difference less than 0 indicates a decrease in mean score.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial CNS Vital Signs assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.|||Scores on a Scale||Standard Deviation|Mean
2692200|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline|Patients completed the 6-minute walk test (6MWT) at each QoL measurement assessment. The 6 minute walk test is a measure of functional capacity in which the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes is measured. The mean difference in distance traveled (in meters) between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in distance traveled, while a difference less than 0 indicates a decrease.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial 6MWT assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.|||Meters||Standard Deviation|Mean
2692201|NCT01303835|Primary|Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline|"The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated.~Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132)~Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients' usual daily activities (range 0-52)~Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24)~Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain)~Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference"|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial QOL assessments and the 16 week QoL assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.|||Scores on a Scale||Standard Deviation|Mean
2692202|NCT01303744|Secondary|Changes in Plasma ΔTNFα Concentrations||29 days|ITT|||pg/ml||Standard Error|Mean
2692203|NCT01303744|Secondary|Measurement of Trough CHF 5074 Plasma Levels|evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.|Days 85||||ng/ml||Standard Deviation|Mean
2692204|NCT01303744|Primary|Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point|To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo|up to 12 weeks|ITT|||pg/ml||Standard Error|Mean
2692205|NCT01303627|Primary|Smooth cLMA Removal Condition (Score 1)|cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)|At the end of the surgery||||percentage of participants|||Number
2692206|NCT01303510|Secondary|Incidence of Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population|||Subjects|||Number
2692207|NCT01303510|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP|||Fold (ratio)|||Number
2692208|NCT01303510|Primary|Seroprotection|Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP|||Subjects|||Number
2692209|NCT01303510|Primary|Seroconversion|Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations exclude one subject lost to follow up|||Subjects|||Number
2700989|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2692210|NCT01303510|Secondary|Safety: Incidence of Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine|||Subjects|||Number
2692211|NCT01303445|Secondary|Percentage Peak-to-trough Fluctuation (%PTF)|PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||percent of average hourly plasma conc.||Standard Deviation|Mean
2692212|NCT01303445|Secondary|Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)|IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.|||percent of baseline platelet aggregation||Standard Deviation|Mean
2692213|NCT01303445|Secondary|Plasma Dipyridamole Minimum Concentration (Cmin)|Minimum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2692214|NCT01303445|Primary|Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)|IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.|||percent of baseline platelet aggregation||Standard Deviation|Mean
2692215|NCT01303445|Primary|Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)|Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||(nanogram/milliliter)*hours||Geometric Coefficient of Variation|Geometric Mean
2692216|NCT01303445|Primary|Plasma Dipyridamole Maximum Concentration (Cmax)|Maximum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2692217|NCT01303419|Primary|Multi-reader Evaluation of Images|Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.|This outcome did not occur due to premature study stop.|Study was prematurely stopped.||||||
2692218|NCT01303419|Primary|Average Maximum Lesion Size by Histology Outcome|Average maximum lesion size as described in histology report.|Approximately 1 week; upon completion of histology report|Subjects who underwent CE-BMRI and DE-CEDM|||millimeters (mm)||Full Range|Mean
2692219|NCT01303419|Primary|Average Maximum Lesion Size by DE-CEDM|Average maximum lesion size when scanned using DE-CEDM|Within 1 week of DE-CEDM scan|All subjects who completed both CE-BMRI and DE-CEDM examinations|||millimeters (mm)||Full Range|Mean
2692220|NCT01303419|Primary|Average Maximum Lesion Size by CE-BMRI Scan|Average maximum lesion size when scanned using CE-BMRI|Within 1 week of CE-BMRI scan|All subjects who completed both CE-BMRI and DE-CEDM examinations|||millimeters (mm)||Full Range|Mean
2692221|NCT01303419|Primary|Completion of CE-BMRI and DE-CEDM|Subjects have completed both CE-BMRI and DE-CEDM scan types|Approximately 8 weeks|Total number of participants enrolled in the study|||Participants|||Count of Participants
2692222|NCT01303406|Secondary|Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms|There was no Withdrawal due to recurrence or worsening of FRDA symptoms|Within 2 months (i.e. Early withdrawal visit)||||percentage of patients|||Number
2692223|NCT01303406|Primary|Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone|The primary efficacy endpoint was the comparison of the number of patients randomized to idebenone and placebo, who assessed that they received idebenone treatment.|At 2 months after study start||||participants|||Number
2692224|NCT01303380|Secondary|Number of Participants Exhibiting Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using bridging ECLIA assay.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.|||Number of participants|||Number
2692225|NCT01303380|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of sandwich ELISA assay with limit of detection at 0.1 picogram/millilitre.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.|||picogram(s)/milliliter||Standard Deviation|Mean
2692226|NCT01303380|Secondary|Serum Concentration-time Profile of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics (PK) of the drug.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.|||microgram(s)/milliliter||Standard Deviation|Mean
2700990|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2692228|NCT01303380|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (Start of study treatment) up to Month 36 (End of study)|The analysis was performed on Safety Set (SAF) population defined as all participants who received at least one application of study treatment and had at least one post-baseline safety assessment.|||Number of participants|||Number
2692229|NCT01303380|Secondary|Time to Flare After the Last Dose of Canakinumab During the Follow-up Period|The median time to flare by the participants after administration of the last dose of canakinumab during the follow-up period was analysed using Kaplan-Meier method.|Last dose of canakinumab treatment in follow-up period to end of follow-up period (Day 337)|"The analysis was performed on the FAS population. Here Number of participants analysed signifies the participants assessed for time to flare after the last dose of canakinumab during follow-up period."|||days||Full Range|Median
2692230|NCT01303380|Secondary|Duration of Flares Experienced During the Study|Flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L. The change in post canakinumab treatment flare duration during the study were assessed as compared to historical period.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.|||Days||Full Range|Median
2692231|NCT01303380|Secondary|Percentage of Participants Who Received Dose Up-titration During 6-month Treatment Period|Participants who experienced a new HIDS flare between baseline and Week 4 and received an escalated dose of 450 mg of canakinumab every 6 weeks thereafter starting at Week 6 were determined.|Day 1 up to Month 6 (End of follow up)|The analysis was performed in the FAS population.|||Percentage of participants|||Number
2692232|NCT01303380|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Global Score in Children Over Time|Participants or their parents (participants aged 6 to 17 years) were assessed for HRQoL based on Childhood Health Assessment Questionnaire (CHAQ). CHAQ was an eight domain questionnaire representing functional capacity and independence, evaluated for previous week. Each domain was rated on a 4-point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do.The total score is the mean from the 8 scores, and ranges from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for CHAQ during study."|||Score on a scale||Full Range|Median
2692233|NCT01303380|Secondary|Health Assessment Questionnaire (HAQ) Global Score in Adults Over Time|Participants were assessed for health-related quality of life (HRQoL) based on Health Assessment Questionnaire (HAQ). HAQ was an eight 8 categories questionnaire representing all activities related to physical function. Each category has various sub-categories, which were rated by the participants on a 4- point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The total score was the mean of the 8 scores, and ranged from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for HAQ during study."|||Score on a scale||Full Range|Median
2692234|NCT01303380|Secondary|Change From Baseline in Inflammation Markers Over Time up to Month 24|The C-reactive Protein (CRP) and/or Serum amyloid A protein (SAA) were used as inflammatory markers. The normal range of CRP was 0-10 mg/L.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.|||milligram(s)/liter||Full Range|Median
2692235|NCT01303380|Secondary|Time to Resolution of the Initial Flare After First Canakinumab Treatment|Time to resolution of the initial flare after first dose of canakinumab was determined.|Day 1 (Baseline), Day 28|The analysis was performed in the FAS population.|||Days||Full Range|Median
2692236|NCT01303380|Secondary|Percentage of Participants Experiencing Abdominal Pain as Assessed by Physician's Global Assessment|Abdominal pain was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2692237|NCT01303380|Secondary|Percentage of Participants Experiencing Lymphadenopathy as Assessed by Physician's Global Assessment|Lymphadenopathy severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2692588|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure|The evaluations using the soft brush were performed 2-3 cm from the incision in the periumbilical region (where the large trocar was placed) 24 h after the procedure|24 h after the procedure||||participants|||Number
2692238|NCT01303380|Secondary|Percentage of Participants Experiencing Apthus Ulcers as Assessed by Physician's Global Assessment|Apthus ulcers were assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2692239|NCT01303380|Secondary|Percentage of Participants Experiencing Fever as Assessed by Physician's Global Assessment|Fever severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2692240|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Physician Assessed Symptom Control|Participants were assessed by physician for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2692241|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Participants Assessed Symptom Control|Participants were assessed by participants/parent (participants aged 6-18 years) for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2692242|NCT01303380|Secondary|Number of Participants With Flare Events Based on Participant Assessed HIDS Flare Severity Score|Participant's global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5-point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe. Same investigator assessed the same participant throughout the study to ensure consistency between assessments. Investigators reviewed every participant's diary at each visit after their own clinical assessment.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.|||Number of participants|||Number
2692243|NCT01303380|Secondary|Number of Participants With Flare Events Based on Physician Assessed HIDS Flare Severity Score|Physician global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5- point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe.|Any flare event [Baseline up to Month 36 (End of long term treatment period 2)]|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Number of participants|||Number
2692244|NCT01303380|Secondary|Number of Participants Who Flared at Month 6, Month 24 and Month 36|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Baseline, Month 6 (End of treatment period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.|||Number of participants|||Number
2692245|NCT01303380|Secondary|Number of Flares Per Participant at During Treatment Period and 24 Month Extension Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Month 6 (End of treatment period), Month 36 (End of Long term treatment Period 2)|The analysis was performed in the FAS population.|||Number of flares||Full Range|Median
2692246|NCT01303380|Primary|Number of Flares Per Participant During Historical Period and Treatment Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a C-reactive protein (CRP) value > 10 mg/L. Flares during a historical period were defined as most recent 6-months in which the participant has not received treatment for their HIDS other than symptomatic treatment with NSAIDs and/or corticosteroids.|Historical period, Month 6 (End of treatment period)|The primary analysis was performed in the Full Analysis set (FAS) population defined as all participants who received at least one dose of study treatment and had at least one post baseline assessment.|||Number of flares||Full Range|Median
2692247|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the male population (226)|||participants|||Number
2692248|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the female population (333)|||participants|||Number
2692589|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure|The evaluations using the soft brush were performed 2-3 cm from the incision in the periumbilical region (where the large trocar was placed) before the procedure|Before the procedure (Baseline)||||participants|||Number
2692249|NCT01303224|Secondary|Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)|"Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from 0= worst imaginable health state to 100=best imaginable health state."|Eight weeks|Intention-to-treat; i.e. all ITT patients who provided EQ-5D data at Visit 2 (start of treatment) and Visit 4 (end of treatment).|||units on a scale||Standard Deviation|Mean
2692250|NCT01303224|Secondary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)"|Eight weeks|Intention-to-Treat (559)|||participants|||Number
2692251|NCT01303224|Primary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).|"Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat (559)|||participants|||Number
2692252|NCT01303159|Secondary|Number of Participants With Adverse Events|To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer|2 years|Preliminary analyses because study was terminated before follow up data could be collected.|||participants|||Number
2692253|NCT01303159|Primary|Change From Baseline in Bile Duct Stricture Diameter|To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer|2 years|Participants not analyzed has study was terminated before follow up data could be collected.||||||
2692254|NCT01303003|Secondary|Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct.||24 hours post-op|No data are available for this study, due to the fact that the PI and study staff have left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.||||||
2692255|NCT01303003|Primary|Time to First Request of Additional Analgesia|Documenting the time required by patients to the first request of additional analgesia.|24 hours post-op|No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.||||||
2692256|NCT01302964|Primary|Proportion of Participants Who Responded to Treatment at 10 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2)|The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). In this study the CGI was focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 were classified as responders. The CGI-I was administered biweekly for 6 weeks and again at 10 weeks during the study. The participant who withdrew from the study before 10 weeks was not included in the calculations.|Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)|All randomized study participants with a 10 week CGI-I rating|||Proportion of participants|||Number
2692257|NCT01302964|Primary|Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase|The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories), and their interaction as covariates, and assuming a common mean between treatment groups at baseline. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.|Weeks Baseline, 2, 4, 6, and 10|All randomized study participants|||score on a scale||95% Confidence Interval|Mean
2692258|NCT01302938|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (<) 0.8 lower limit of normal(LLN); platelet <0.5 LLN, >1.75 upper LN (ULN);white blood cell <0.6 LLN, >1.5 ULN; lymphocyte, total neutrophil(absolute[AL]),Total protein, albumin, phosphate <0.8 LLN, >1.2 ULN; basophil, eosinophil, monocyte >1.2ULN; Total bilirubin >1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase >3ULN; Blood urea nitrogen, creatinine >1.3ULN; sodium <0.95LLN, >1.05ULN; potassium, chloride, bicarbonate, calcium <0.9LLN, >1.1ULN.|Week 12|Safety set included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2692259|NCT01302938|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.|||participants|||Number
2692647|NCT01300767|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692260|NCT01302938|Other Pre-specified|Number of Participants With Adverse Events (AEs) by Relatedness and Severity|AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.|||participants|||Number
2692261|NCT01302938|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.|||participants|||Number
2692262|NCT01302938|Secondary|Participant Perception Regarding Recommending a Friend to Enter Similar Study|"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 6, How likely would you be to recommend a friend to enter a similar study? are reported."|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2692263|NCT01302938|Secondary|Participant Perception Regarding Received Treatment in the Study|"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 5, What treatment did you think you were on? are reported."|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2692264|NCT01302938|Secondary|Participant Perception Regarding Cell Phone Diary|"PEQ:self-administered, assesses participants perception of trial method. Question4, How satisfied were you with items? on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened."|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2692265|NCT01302938|Secondary|Participant Perception Regarding Satisfaction Related to Study|"PEQ:self-administered, to assess perception of trial method. Question3, How satisfied were you with items? on scale 1(very satisfied) to 5(very dissatisfied)- recruitment; questionnaires,surveys(Ques,Sur); identification verification(IV); informed consent(IC) process; website experience; phone call; laboratory(lab) kit delivery; lab location; lab staff service(Ser); physical exam(PE) scheduling,location (sch,loc); PE visit; medication(med) first batch delivery; med second batch delivery; cell phone(CP) received; CP use; call center(CC) ser; medical support(supp); technical supp; overall."|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2692266|NCT01302938|Secondary|Number of Participants With Reason for Participation in the Study|"PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 2, What led you to participate given the study drug is already available? are reported."|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2692267|NCT01302938|Secondary|Number of Participants With Response Regarding Source of First Information About Study|"Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant's perception of trial method. Number of participants who responded to question 1, Where did you hear first about the study? are reported."|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2692268|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Full Range|Median
2692289|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692648|NCT01300767|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692269|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2692270|NCT01302938|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2692271|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12|PPUS: a self-administered, single-item, validated questionnaire that measures the participant's perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet [without leaking]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC).|Baseline (Bl), Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||participants|||Number
2692272|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12|PPBC: self-administered,single-item questionnaire to describe participant's perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC).|Baseline, Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||participants|||Number
2692273|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||episodes per 24 hours||Standard Deviation|Mean
2692274|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related nocturnal urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 that occurred between time participant went to bed and time participant arose to start next day divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.||||||
2692275|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.||||||
2692290|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692649|NCT01300767|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692276|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||micturitions per 24 hours||Standard Deviation|Mean
2692277|NCT01302938|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||episodes per 24 hours||Full Range|Median
2692278|NCT01302938|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||milliliter (mL)||Standard Deviation|Mean
2692279|NCT01302938|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using Last observation carried forward (LOCF) method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||micturitions per 24 hours||Standard Deviation|Mean
2692280|NCT01302899|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril||26 weeks|The safety analysis set consisted of all patients who received at least one study drug and had no major protocol deviations that could have impacted safety data.|||Participants|||Number
2692281|NCT01302899|Secondary|Plasma Rennin Concentration (PRC)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692282|NCT01302899|Secondary|Plasma Rennin Activity (PRA)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692283|NCT01302899|Secondary|Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692284|NCT01302899|Secondary|Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692285|NCT01302899|Secondary|Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692286|NCT01302899|Secondary|Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function|All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692287|NCT01302899|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692288|NCT01302899|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2692291|NCT01302860|Secondary|Number of Participants With Anti-canakinumab Antibodies at Week 56|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|Week 56 (End of study)|The analysis was performed in the safety set population. Here, ‘Number of participants analysed’ signifies participants who had immunogenicity samples taken and analyzed during the study.|||participants|||Number
2692292|NCT01302860|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|Day -14 (prior-vaccination), Day 0 (vaccination), Day 28, Day 57 (post-vaccination)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies evaluable participants who received a total of 31 vaccinations during the study."|||vaccination cases|||Number
2692293|NCT01302860|Secondary|Percentage of Participants Receiving a Concomitant Vaccination During the Study|Participants received any one of the following inactivated vaccines as per the immunization program: Corynebacterium diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, Influenza type A, Influenza type B, Haemophilus influenza B, Streptococcus pneumoniae, or Hepatitis B were determined.|Day 1 (start of study treatment) to Week 56 (end of study)|The analysis was performed in the FAS population.|||Percentage of participants|||Number
2692294|NCT01302860|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (start of study treatment) up to Week 56 (end of study)|The analysis was performed in the safety set population defined as participants who received at least one dose of study drug. Here, ‘n’ signifies participants evaluable for this measure at specified time points for each group, respectively.|||participants|||Number
2692295|NCT01302860|Secondary|Change From Baseline in C--Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations at Week 56|The CRP and SAA were used as inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Baseline, Week 56|The analysis was performed in FAS population. Here ‘n’ signifies those participants with evaluable measurements at both baseline and the post-baseline visit.|||mg/L||Standard Deviation|Mean
2692296|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician Assessment of Skin Disease at Week 56|Participants were assessed by physician for skin disease (urticarial skin rash) measured on a 5--point scale as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.|||Percentage of participants|||Number
2692297|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician's Global Assessment Score at Week 56|Participants were assessed based by physician on Physician's Global Assessment measured on a 5--point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.|||Percentage of participants|||Number
2692298|NCT01302860|Secondary|Percentage of Participants Aged 2 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as CRP or SAA to be <15 mg/L and <10 mg/L respectively.|Week 56|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants aged 2 years or younger."|||Percentage of participants|||Number
2692299|NCT01302860|Primary|Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as C reactive protein (CRP) or Serum amyloid A protein (SAA) to be less than (<) 15 milligram per liter (mg/L) and <10 mg/L respectively.|Week 56|The analysis was performed in Full analysis set (FAS), defined as all participants who received at least one dose of study drug under this study protocol.|||Percentage of participants|||Number
2692300|NCT01302834|Secondary|Translational Research Analysis||From randomization to date of death or last follow-up.||2021-03-31|03/2021||||
2692301|NCT01302834|Secondary|Behavioral Risk Assessment Survey (BRASS) at Baseline.||Prior to randomization.||2021-03-31|03/2021||||
2692302|NCT01302834|Secondary|Hearing Quality of Life Outcomes as Measured by the Hearing Handicap Inventory for Adults (HHIA-S) at Baseline, End of Treatment and at 3, 6, and 12 Months From End of Treatment.||From randomization to 1 year after end of treatment.||2021-03-31|03/2021||||
2692303|NCT01302834|Secondary|Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment|"his study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = Normal: Edentulous, with no gingival disease;~1 = Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."|10 years after end of treatment (approximately 121.5 months)||2025-08-31|08/2025||||
2692337|NCT01302548|Secondary|Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.|"The Abscess Measurement Scale was measured using a centimeter ruler.~Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild"|48 hours|Only participants that were MRSA-positive, were analyzed.|||units on a scale||Standard Deviation|Mean
2692304|NCT01302834|Secondary|Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment|"This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = Normal: Edentulous, with no gingival disease; 1 = Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."|5 years after end of treatment (approximately 61.5 months)|Eligible patients who started study treatment and had dental status assessment at 5 years after treatment end|||percentage of participants||95% Confidence Interval|Number
2692305|NCT01302834|Secondary|Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment|"This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = Normal: Edentulous, with no gingival disease; 1 = Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."|2 years after end of treatment (approximately 25.5 months)|Eligible patients who started study treatment and had dental status assessment at 2 years after treatment end|||percentage of participants||95% Confidence Interval|Number
2692306|NCT01302834|Secondary|Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment|"This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = Normal: Edentulous, with no gingival disease;~1 = Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated."|1 year after end of treatment (approximately 13.5 months)|Eligible patients who started study treatment and had dental status assessment at 1 year after treatment end|||percentage of participants||95% Confidence Interval|Number
2692307|NCT01302834|Secondary|Percentage of Patients With Normal/Good Dental Health: Pretreatment|"This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = Normal: Edentulous, with no gingival disease;~1 = Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; < 5 restorations indicated; no extractions indicated. Ten year data is not yet available."|Before treatment|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2692308|NCT01302834|Secondary|Work Status Questionnaire at Baseline, End of Treatment, 3, 6, and 12 Months.||From randomization to 1 year after end of treatment.||2021-03-31|03/2021||||
2692309|NCT01302834|Secondary|EuroQol Five Dimension Scale (EQ-5D) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.||From randomization to 1 year after end of treatment.||2021-03-31|03/2021||||
2692310|NCT01302834|Secondary|Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.||From randomization to 1 year after end of treatment.||2021-03-31|03/2021||||
2692311|NCT01302834|Secondary|EORTC QLQ-H&N35 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.||From randomization to 1 year after end of treatment.||2021-03-31|03/2021||||
2692312|NCT01302834|Secondary|EORTC QLQ-C30 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.||From randomization to 1 year after end of treatment.||2021-03-31|03/2021||||
2692313|NCT01302834|Secondary|Percentage of Participants With a Feeding Tube at 1 Year||From randomization to 1 year.|Eligible patients who started study treatment and had feeding tube assessment at 1 year|||percentage of participants||95% Confidence Interval|Number
2692314|NCT01302834|Secondary|Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment|"Late adverse events (AE) are defined as > 180 days from end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From start of treatment to approximately 61.5 months (five years after the end of treatment)|Eligible patients who started study treatment and had adverse events assessment at 5 years after treatment end|||percentage of participants||95% Confidence Interval|Number
2692315|NCT01302834|Secondary|Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment|"Late adverse events (AE) are defined as > 180 days from end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From 180 days after end of treatment to two years after end of treatment.|.Eligible patients who started study treatment and had adverse events assessment at 2 years after treatment end|||percentage of participants||95% Confidence Interval|Number
2692316|NCT01302834|Secondary|Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment|"Late adverse events (AE) are defined as > 180 days from end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From start of treatment to approximately 13.5 months (one year after the end of treatment)|Eligible patients who started study treatment and had adverse events assessment at 1 year after treatment end|||percentage of participants||95% Confidence Interval|Number
2692336|NCT01302691|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
2692317|NCT01302834|Secondary|Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment|"Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From start of treatment to approximately 7.5 months (6 months after the end of treatment)|Eligible patients who started study treatment and had adverse events assessment at 6 months year after treatment end|||percentage of participants||95% Confidence Interval|Number
2692318|NCT01302834|Secondary|Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment|"Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From start of treatment to approximately 4.5 months (3 months after the end of treatment)|Eligible patients who started study treatment and had adverse events assessment at 3 months after treatment end|||percentage of participants||95% Confidence Interval|Number
2692319|NCT01302834|Secondary|Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment|"Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From start of treatment to approximately 2.5 months (1 month after the end of treatment)|Eligible patients who started study treatment and had adverse events assessment at 1 month after treatment end|||percentage of participants||95% Confidence Interval|Number
2692320|NCT01302834|Secondary|Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment|"Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. Treatment-related means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE"|From start of treatment to end of treatment, approximately 6 weeks|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2692321|NCT01302834|Secondary|Percentage of Participants Experiencing Early Death|Early death is defined as death due to adverse event or within 30 days of treatment completion.|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2692322|NCT01302834|Secondary|Distribution of First Progression Events|"The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as Pattern of failure."|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible participants with progression-free survival failure|||Participants|||Count of Participants
2692323|NCT01302834|Secondary|Time to Secondary Primary Cancer|Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2692324|NCT01302834|Secondary|Time to Distant Metastasis|Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2692335|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2692325|NCT01302834|Secondary|Time to Local-regional Failure|Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2692326|NCT01302834|Secondary|Progression-free Survival|An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2692327|NCT01302834|Primary|Overall Survival|An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.|From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2692328|NCT01302743|Primary|Decrease in LDL Cholesterol|Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.|90 days|no data was analyzed as study was stopped early due to low recruitment||||||
2692329|NCT01302743|Primary|Decrease in HbA1c|Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.|90 days|no data was analyzed as study was stopped early due to low recruitment||||||
2692330|NCT01302691|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
2692331|NCT01302691|Primary|Percentage of Participants Who Had Study Drug Stopped Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm|up to 8 weeks|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2692332|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related SAE|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2692333|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2692334|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2692339|NCT01302548|Primary|Abscess Healing Based on Abscess Measurement Scale|"The abscess healing process will use two methods: 1) usual method includes saline irrigation and/or incision & drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler.~Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild"|48 hours||||units on a scale||Standard Deviation|Mean
2692340|NCT01302483|Secondary|Maximum Change in Pulse Oximetry From Baseline|Maximum change from Baseline at any time point|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intent to Treat|||SpO2||Standard Deviation|Mean
2692341|NCT01302483|Secondary|Maximum Change in Blood Pressure From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40 50, 60, 120 minutes|Intention to treat|||mmHG||Standard Deviation|Mean
2692342|NCT01302483|Secondary|Maximum Change in Pulse From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intention to treat|||beats per minute||Standard Deviation|Mean
2692343|NCT01302483|Secondary|Soft Tissue Anesthesia Duration|"Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were:~Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule~Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule~Site 3: Incisive papilla~Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)"|Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes|Intention to treat|||Minutes||Standard Deviation|Mean
2692344|NCT01302483|Primary|Pulpal Anesthesia|Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.|Continuous throughout dental treatment period (up to 60 minutes)|Intention to treat|||participants|||Number
2692345|NCT01302444|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP)as Assessed by Transthoracic Echocardiography Using Doppler Ultrasound||16 weeks|data not reported for one participant for anonymity||||||
2692346|NCT01302444|Secondary|Plasma BNP (Brain Natriuretic Peptide)Level Change||16 weeks of therapy|data not reported for one participant for anonymity||||||
2692347|NCT01302444|Secondary|Tei Index Change by Transthoracic Echocardiography||16 weeks of therapy|data not reported for one participant for anonymity||||||
2692348|NCT01302444|Secondary|6 Minute Walking Distance Change Will Improve||16 weeks of therapy|data not reported for one participant for anonymity||||||
2692349|NCT01302444|Primary|Hospitalizations||16 weeks|data not reported for one participant for anonymity||||||
2692350|NCT01302444|Primary|WHO Functional Class Will Improve or Remain Stable||16 weeks|data not reported for one participant for anonymity||||||
2692351|NCT01302444|Primary|Adverse Events Are no Greater Than With Treprostinil Infusion Alone||16 weeks|data not reported for one participant for anonymity||||||
2692352|NCT01302444|Primary|All Cause Mortality||16 weeks|data not reported for one participant for anonymity||||||
2692353|NCT01302418|Primary|Detection of Respiratory Viruses|The presence of Influenza A or Influenza B virus.|Specimens will be taken within 5 days of the appearance of symptoms.|All subjects meeting inclusion/ exclusion criteria and who had sufficient specimen volume.|||participants|||Number
2692354|NCT01302392|Secondary|Duration of Disease Control|Duration of Disease Control was calculated for subjects who achieved disease control. Duration of Disease Control was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving disease control through the final analysis data cutoff with longest follow-up time of approximately 31 months.|The intent to treat (ITT) population comprised randomized participants who achieved disease control.|||months||95% Confidence Interval|Median
2692355|NCT01302392|Secondary|Disease Control|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||participants|||Number
2692356|NCT01302392|Secondary|Duration of Clinical Benefit|Duration of Clinical Benefit was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) or minimal response (MR). Duration of Clinical Benefit was defined as the time in months from the initial start of response (MR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving clinical benefit through the final analysis data cutoff with longest follow-up time of approximately 30 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of MR or better only.|||months||95% Confidence Interval|Median
2692357|NCT01302392|Secondary|Clinical Benefit Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||participants|||Number
2695947|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2692358|NCT01302392|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of PR or better only.|||months||95% Confidence Interval|Median
2692359|NCT01302392|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||participants|||Number
2692360|NCT01302392|Secondary|Progression-free Survival|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||months||95% Confidence Interval|Median
2692361|NCT01302392|Primary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at date when the subject is last known alive or the data cutoff date, whichever occurs earlier.|From randomization through the final analysis data cutoff with longest follow-up time of approximately 45 months. Median follow up times were 27.8 months and 29.8 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||months||95% Confidence Interval|Median
2692362|NCT01302366|Primary|Duration of Response (Excluding Patient Choice and Non-compliance)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years|All patients or the patients excluding personal choice or non-compliance|||months||Full Range|Median
2692363|NCT01302366|Secondary|Percentage of Patients Who Have Responded to TBL12|Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)|2 months|all patients|||percentage of participants|||Number
2692364|NCT01302366|Primary|Duration of Response (All Treated Patients)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years||||months||Full Range|Median
2692365|NCT01302119|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2692366|NCT01302119|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2692367|NCT01302119|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2692368|NCT01302119|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2692369|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 12.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 12.|||Percentage of participants|||Number
2692370|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 4.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI >0 per 24 hours and non-missing change from baseline to Week 4.|||Percentage of participants|||Number
2692371|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
2692372|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
2692373|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
2692374|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
2692375|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
2692376|NCT01302067|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
2692377|NCT01302067|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.|"UPS: single-item, self-administered validated questionnaire. Participant answered: Which of the following would typically describe your experience when you have a desire to urinate? on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change)."|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.|||Participants|||Number
2692378|NCT01302067|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.|||Participants|||Number
2692379|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.|||Participant||Full Range|Median
2692380|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 4.|||Participant||Full Range|Median
2692381|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Standard Error|Least Squares Mean
2692382|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Standard Error|Least Squares Mean
2692383|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Full Range|Median
2692384|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Full Range|Median
2692385|NCT01302067|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Standard Error|Least Squares Mean
2692386|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Full Range|Median
2692387|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Full Range|Median
2695948|NCT01274559|Primary|Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2692388|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Standard Error|Least Squares Mean
2692389|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Standard Error|Least Squares Mean
2692390|NCT01302067|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI >0 per 24 hours & non-missing change from BL to Week 12 were included.|||Episodes per 24 hours||Standard Error|Least Squares Mean
2692391|NCT01302054|Secondary|Percentage of Participants With No UUI Episodes (Diary Dry Rate)|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).|||percentage of participants|||Number
2692392|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||percentage of participants|||Number
2692393|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week -2, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||percentage of participants|||Number
2692394|NCT01302054|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2692395|NCT01302054|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2692396|NCT01302054|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12|"UPS: single-item, self-administered validated questionnaire. Participant answered: Which of the following would typically describe your experience when you have a desire to urinate? on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change)."|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||participants|||Number
2692476|NCT01301625|Secondary|Six Minute Walking Distance|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.|Baseline|Six-minuted walk test (6MWT) distance is available for 76 patients at baseline because 2 patients did not complete the 6MWT at baseline.|||Meters||Standard Deviation|Mean
2692397|NCT01302054|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12|"PPBC: single-item, self-administered validated questionnaire. Participant answered: Which of the following statements describes your bladder condition best at the moment? on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2)."|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||participants|||Number
2692398|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline urgency episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2692399|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline micturitions >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||micturitions per 24 hours||Standard Deviation|Mean
2692400|NCT01302054|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2692401|NCT01302054|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12(LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2692402|NCT01302041|Secondary|PSA Doubling Time|PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.|From Baseline to Week 25|Safety Analysis Set with a positive PSA versus time slope||||||
2692403|NCT01302041|Secondary|Time to PSA Progression|Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
2692404|NCT01302041|Secondary|Time to PSA ≤ 0.1 ng/ml|"Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded.~Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method."|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
2692405|NCT01302041|Secondary|Time to PSA ≤ 4 ng/ml|Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
2692406|NCT01302041|Secondary|Time to PSA Decline ≥ 90%|Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
2692407|NCT01302041|Secondary|Time to PSA Response|Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
2692650|NCT01300767|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692408|NCT01302041|Secondary|Maximum Decline From Baseline in PSA|The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.|Baseline to Week 25 and from Baseline up to the EOS date of 27 Apr 2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692409|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 0.1 ng/ml|Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, 97 or 169 were considered non-responders.|Weeks 25, 49, 97 and 169|Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point|||Percentage of Participants|||Number
2692410|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 4 ng/ml|Participants with unknown or missing PSA results at week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25. Participants with unknown or missing PSA results at week 49, 97 and 169 were considered non-responders.|Weeks 25, 49, 97 and 169|Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point|||Percentage of Participants|||Number
2692411|NCT01302041|Secondary|Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level|Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, week 97 or week 169 were considered non-responders.|Baseline and Weeks 25, 49, 97 and 169|Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point|||Percentage of Participants|||Number
2692412|NCT01302041|Secondary|Percentage of Participants With a PSA Response at Weeks 49, 97 and 169|A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 49, week 97 or week 169 for any reason were treated as non-responders.|Baseline and Weeks 49, 97 and 169|Safety Analysis Set|||Percentage of Participants||95% Confidence Interval|Number
2692413|NCT01302041|Secondary|Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|Pharmacokinetic Analysis Set with available data at each time point|||μg/mL||Standard Deviation|Mean
2692414|NCT01302041|Secondary|Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|Pharmacokinetic Analysis Set (PKAS) (participants who had taken at least 1 dose of study drug and who had at least 1 pharmacokinetic concentration value) with available data at each time point|||μg/mL||Standard Deviation|Mean
2692415|NCT01302041|Secondary|Percent Change From Baseline in Free Testosterone||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692416|NCT01302041|Secondary|Percent Change From Baseline in Total Testosterone||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692417|NCT01302041|Secondary|Percent Change From Baseline in Prolactin||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692418|NCT01302041|Secondary|Percent Change From Baseline in Luteinizing Hormone (LH)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692419|NCT01302041|Secondary|Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692420|NCT01302041|Secondary|Percent Change From Baseline in Estradiol||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692421|NCT01302041|Secondary|Percent Change From Baseline in Dihydrotestosterone (DHT)||Baseline and Week 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692422|NCT01302041|Secondary|Percent Change From Baseline in Dehydroepiandrosterone (DHEA)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692423|NCT01302041|Secondary|Percent Change From Baseline in Androstenedione||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692424|NCT01302041|Secondary|Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692425|NCT01302041|Secondary|Percent Change From Baseline in PSA||Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
2692426|NCT01302041|Secondary|Number of Participants With Adverse Events|"Each adverse event (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs).~A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening~Resulted in persistent or significant disability/incapacity~Resulted in congenital anomaly or birth defect~Required inpatient hospitalization or led to prolongation of hospitalization~Other medically important events."|From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Participants|||Count of Participants
2692427|NCT01302041|Primary|Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25|A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.|Baseline and Week 25|The analysis population was safety analysis set (SAF), which consisted of participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2692428|NCT01301963|Secondary|Compare Need for Remobilization Between Mobilization Groups|Using the Chi-square test or Fisher's exact test, as appropriate.|Day 1|||||||
2692431|NCT01301963|Secondary|Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other|Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.|By day 1|||||||
2692432|NCT01301963|Secondary|Percentage of Patients Achieving Target Goal CD34+ Cells Dose||In =< 5 days of leukaphereses|Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study||||||
2692433|NCT01301963|Primary|Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg||In =< 2 days of leukaphereses|due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study||||||
2692434|NCT01301950|Secondary|To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location||Intraoperative|No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.||||||
2692435|NCT01301950|Secondary|Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures|Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .|Intraoperative (Total duration of procedure)|No cost data were collected, resulting in a sample size of 0.||||||
2692436|NCT01301950|Secondary|Turnover Time (Time to Clean Operating Room After Surgery is Completed)|Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].|Intraoperative (Time to clean Operating Room after surgery is completed)|1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection.|||minutes||Standard Deviation|Mean
2692437|NCT01301950|Secondary|Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete|Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]|Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)||||minutes||Standard Deviation|Mean
2692438|NCT01301950|Primary|Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements|Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).|Intraoperative (Time from first incision to first stitch)||||minutes||Standard Deviation|Mean
2692439|NCT01301833|Secondary|Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||μU / mL||Standard Deviation|Mean
2692440|NCT01301833|Secondary|Change From Baseline in Fasting Glucagon at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||pg / mL||Standard Deviation|Mean
2692441|NCT01301833|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||mg / dL||Standard Deviation|Mean
2692442|NCT01301833|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||Percent||Standard Deviation|Mean
2692443|NCT01301833|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 Weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.|||participants|||Number
2692444|NCT01301742|Secondary|Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.~The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2692445|NCT01301742|Primary|Total Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.~The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2692531|NCT01301456|Secondary|Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2||Baseline, Day 8, 15, 22, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
2692446|NCT01301742|Primary|Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.~The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2692447|NCT01301729|Secondary|Time to Progression|Time to progression was defined as the time from the date of enrollment until the date of progressive disease.|From the date of enrollment until the date of progressive disease (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||months||95% Confidence Interval|Median
2692448|NCT01301729|Secondary|Clinical Benefit Rate|Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||percentage of participants||95% Confidence Interval|Number
2692449|NCT01301729|Secondary|Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)||up to 28 months|Biomarker analysis was not performed as the eligible biomarker sample quantity was too limited for testing.||||||
2692450|NCT01301729|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 28 days after last infusion of the study drug (28 months)|Safety population is defined as all enrolled participants and have taken at least one dose of study drug.|||percentage of participants|||Number
2692451|NCT01301729|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.|Time from enrollment to the date of death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||months||95% Confidence Interval|Median
2692452|NCT01301729|Secondary|Duration of Response|Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions.|From the time of PR or CR until the date of PD or death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study. Here, number of participants are the participants who had response.|||months||95% Confidence Interval|Median
2692453|NCT01301729|Secondary|Overall Response Rate|Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||percentage of participants||95% Confidence Interval|Number
2692454|NCT01301729|Primary|Progression-Free Survival (PFS)|PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.|From the date of informed consent to the date of death or progressive disease (up to 28 months)|Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study.|||months||95% Confidence Interval|Median
2692455|NCT01301625|Secondary|Post-procedure Hospital Stay|This is the Economic data reported to support the MitraClip System economic analysis. It is defined as the mean duration of time that patients spent in hospital following the MitraClip procedure.|Post index procedure within 30 days|Duration of post-procedure hospital stay was not available for 3 patients.|||Days||Standard Deviation|Mean
2692456|NCT01301625|Secondary|Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration|ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure.|Post index procedure within 30 days|Post-Procedure ICU/CCU/PACU duration was not available for 4 patients.|||Hours||Standard Deviation|Mean
2692457|NCT01301625|Secondary|Number of Participants at Discharge Facility|This is the economic data reported to support the MitraClip System economic analysis.|< or = 12 days||||Participants|||Count of Participants
2692458|NCT01301625|Secondary|Duration of Rehospitalization||30 days||||Days||Standard Deviation|Mean
2692459|NCT01301625|Secondary|Rate of Patients Rehospitalized|Defined as re-admission of patients to the hospital following discharge from the Clip procedure.|30 days||||Participants|||Count of Participants
2692460|NCT01301625|Secondary|Number of Participants With Second Intervention to Place an Additional MitraClip Device|Second MitraClip device interventions are reported by Abbott Vascular personnel on Procedural Observation Forms. A second MitraClip device intervention is a good option for patients with MR following placement of the original MitraClip device.|Through 12 months||||Participants|||Count of Participants
2692461|NCT01301625|Secondary|Number of Participants With Mitral Valve Surgery|Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair.|30 days of Post-MitraClip Procedure||||Participants|||Count of Participants
2692462|NCT01301625|Secondary|Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)|"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary."|12 months|"At 12 months, 31 patients were considered at risk because 38 had been censored and 9 patients experienced an event (i.e. death or CHF event)."|||percentage of participants|||Number
2692463|NCT01301625|Secondary|Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)|"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary."|6 months|"At 6 months, 55 patients were considered at risk because 17 had been censored, and 6 patients experienced an event (i.e. death or CHF event)."|||percentage of participants|||Number
2692464|NCT01301625|Secondary|Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)|"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary."|30 days|"Two patient were lost to follow-up at the 30-day time point and 1 had been censored at Baseline. Therefore, 73 patients were included in the at risk population in the Kaplan-Meier freedom from death and congestive heart failure analysis at 30 days."|||percentage of participants|||Number
2692465|NCT01301625|Secondary|Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)|"Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.~Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary."|Baseline||||percentage of participants|||Number
2692466|NCT01301625|Secondary|Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months|"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)."|12 months|Paired MLHFQ quality of life data was available for 40 patients at Baseline and 12 months.Five patients died prior to the 12-month visit,1 patient missed the 12-month visit,3 patients did not complete the MLHFQ assessment. Finally, 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||scores on a scale||Standard Deviation|Mean
2692467|NCT01301625|Secondary|Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months|"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)."|6 months|Paired Minnesota Living with Heart Failure Questionnaire (MLHFQ) quality of life data was available for 61 patients at Baseline and 6 months. Four patients died prior to the 6-month visit,1 patient missed the 6-month visit and 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.|||scores on a scale||Standard Deviation|Mean
2696961|NCT01265550|Secondary|Number of Enrolled Participants With Functional Vomiting||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional vomiting|||Participants|||Count of Participants
2692468|NCT01301625|Secondary|Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days|"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)."|30 days|Paired Minnesota Living with Heart Failure Questionnaire (MLHFQ) quality of life data was available for 70 patients at Baseline and 30 days. Six patients missed their 30-day visit and 2 patients did not complete the MLHFQ at either baseline, 30 days, or both time points.|||scores on a scale||Standard Deviation|Mean
2692469|NCT01301625|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class|"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|NYHA functional class assessment is available for 40 patients at 12 months.Five patients died prior to the 12-month visit,1 patient missed the 12-month visit, 3 patients did not have a NYHA functional class assessment and finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||percentage of participants|||Number
2692470|NCT01301625|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class|"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|NYHA functional class assessment is available for 60 patients at 6 months. Four patients died prior to the 6-month visit, 1 patient missed the 6-month visit, 1 patient did not have a NYHA functional class assessment at 6-months, and finally 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.|||percentage of participants|||Number
2692471|NCT01301625|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class|"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|A total of 69 patients were included in analysis population because 6 patients had lost-to-follow up at 30 days and 3 patients did not have a NYHA functional class assessment.|||percentage of participants|||Number
2692472|NCT01301625|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class|"Class I Patients with cardiac disease but without resulting limitations of physical activity;~Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;~Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;~Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline||||percentage of participants|||Number
2692473|NCT01301625|Secondary|Six Minute Walking Distance|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.|12 months|Six-minuted walk test (6MWT) distance is available for 39 patients at 12 months. Five patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 4 patients did not complete the 6MWT at 12 months, and finally 29 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.|||Meters||Standard Deviation|Mean
2692474|NCT01301625|Secondary|Six Minute Walking Distance|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.|6 months|Six-minuted walk test (6MWT) distance is available for 60 patients at 6 months. Four patients died prior to the 6-month visit, 1 patient missed the 6-month visit, 1 patient did not complete the 6MWT at 6-months, and finally, 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.|||Meters||Standard Deviation|Mean
2692475|NCT01301625|Secondary|Six Minute Walking Distance|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.|30 days|Six-minuted walk test (6MWT) distance is available for 68 patients at 30 days. Six patients missed the 30-day visit and 4 patients did not complete the 6MWT at 30-days.|||Meters||Standard Deviation|Mean
2692477|NCT01301625|Secondary|Left Atrial Volume|Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.|At Baseline and 12 Months|A total of 39 patients had paired LA volume measurements because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 4 patients have missing LA volume data at either baseline, 12 months, or both time points and 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||ml||Standard Deviation|Mean
2692478|NCT01301625|Secondary|Left Atrial Volume|Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.|At Baseline and 30 Days|A total of 62 patients had paired left atrial (LA) volume measurements at both baseline and 30 days. Six patients missed the 30-day visit, Where as LA volume data at either baseline, 30 days, or both time points are missing for 10 patients.|||ml||Standard Deviation|Mean
2692479|NCT01301625|Secondary|Left Atrial Volume|Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.|At Baseline and Discharge (≤7 days of index procedure)|A total of 67 patients had paired left atrial (LA) volume measurements at both baseline and discharge. LA volume data at either baseline, discharge, or both time points are missing for 11 patients.|||ml||Standard Deviation|Mean
2692480|NCT01301625|Secondary|Mitral Valve Mean Gradient|Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|At Baseline and 12 Months|A total of 34 patients had paired MVG measurements because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 9 patients have missing MVG data at either baseline, 12 months, or both time points. Finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||mmHg||Standard Deviation|Mean
2692481|NCT01301625|Secondary|Mitral Valve Mean Gradient|Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|At Baseline and 30 Days|A total of 59 patients had paired mitral valve mean gradient (MVG) measurements at both baseline and 30 days. Six patients missed the 30-day visit. MVG data at either baseline, 30 days, or both time points are missing for 13 patients.|||mmHg||Standard Deviation|Mean
2692482|NCT01301625|Secondary|Mitral Valve Mean Gradient|Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|At Baseline and Discharge (≤7 days of index procedure)|A total of 65 patients had paired mitral valve mean gradient (MVG) measurements at both baseline and discharge. MVG data at either baseline, discharge, or both time points is missing for 13 patients.|||mmHg||Standard Deviation|Mean
2692483|NCT01301625|Secondary|Mitral Valve Area (MVA) by Pressure Half-time (PHT)|Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.|At Baseline and 12 Months|A total of 29 patients were analyzed because 5 patients died prior to the 12-month visit,1 patient missed the 12-month visit, 14 patients have missing MVA data at either baseline, 12 months, or both time points. Finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||cm^2||Standard Deviation|Mean
2692484|NCT01301625|Secondary|Mitral Valve Area (MVA) by Pressure Half-time (PHT)|Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.|At Baseline and 30 Days|A total of 50 patients had paired mitral valve area (MVA) by pressure half-time measurements at both baseline and 30 days. Six patients missed the 30-day visit. Where as, regurgitant fraction data at either baseline, 30 days, or both time points is missing for 22 patients.|||cm^2||Standard Deviation|Mean
2692485|NCT01301625|Secondary|Mitral Valve Area (MVA) by Pressure Half-time (PHT)|Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.|At Baseline and Discharge (≤7 days of index procedure)|A total of 54 patients had paired mitral valve area (MVA) by pressure half-time measurements at both baseline and discharge. MVA data at either baseline, discharge, or both time points is missing for 24 patients.|||cm^2||Standard Deviation|Mean
2692486|NCT01301625|Secondary|Regurgitant Fraction|Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|At Baseline and 12 Months|Few patients excluded from analysis population because 5 patients died prior to the 12-month visit,1 patient missed the 12-month visit, 38 patients have missing regurgitant fraction data at either baseline, 12 months, or both time points and 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||Percentage||Standard Deviation|Mean
2692487|NCT01301625|Secondary|Regurgitant Fraction|Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|At Baseline and 30 Days|A total of 16 patients had paired regurgitant fraction measurements at both baseline and 30 days. Six patients missed the 30-day visit. Whereas, regurgitant fraction data at either baseline, 30 days, or both time points is missing for 56 patients.|||Percentage||Standard Deviation|Mean
2692488|NCT01301625|Secondary|Regurgitant Fraction|Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|At Baseline and Discharge (≤7 days of index procedure)|A total of 18 patients had paired regurgitant fraction measurements at both baseline and discharge. Regurgitant fraction data at either baseline, discharge, or both time points is missing for 60 patients.|||Percentage||Standard Deviation|Mean
2692532|NCT01301456|Secondary|Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1||Baseline, Day 8, 15 and 29|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2692489|NCT01301625|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|At Baseline and 12 Months|A total of 20 patients were included in analysis because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 23 patients have missing regurgitant volume data at either baseline, 12 months, or both time points & 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||ml||Standard Deviation|Mean
2692490|NCT01301625|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|At Baseline and 30 Days|A total of 36 patients had paired regurgitant volume measurements at both baseline and 30 days. Six patients missed the 30-day visit and regurgitant volume data at either baseline, 30 days, or both time points is missing for 36 patients.|||ml||Standard Deviation|Mean
2692491|NCT01301625|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|At Baseline and Discharge (≤7 days of index procedure)|A total of 45 patients had paired regurgitant volume measurements at both baseline and discharge. Regurgitant volume data at either baseline, discharge, or both time points is missing for 33 patients.|||ml||Standard Deviation|Mean
2692492|NCT01301625|Secondary|Left Ventricular Internal Diameter End Systole (LVIDs)|LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.|At Baseline and 12 Months|A total of 36 patients had paired LVIDs measurements Because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 7 patients had missing LVIDs at either baseline, the 12-month visit, or both time points and 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||cm||Standard Deviation|Mean
2692493|NCT01301625|Secondary|Left Ventricular Internal Diameter End Systole (LVIDs)|LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.|At Baseline and 30 Days|A total of 61 patients had paired left ventricular internal diameter in systole (LVIDs) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 11 patients had missing LVIDs at either baseline, the 30-day visit, or both time points.|||cm||Standard Deviation|Mean
2692494|NCT01301625|Secondary|Left Ventricular Internal Diameter End Systole (LVIDs)|LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.|At Baseline and Discharge (≤7 days of index procedure)|A total of 71 patients had paired left ventricular internal diameter in systole (LVIDs) measurements at both baseline and discharge. Seven patients had missing LVIDs at either baseline, discharge, or both time points.|||cm||Standard Deviation|Mean
2692495|NCT01301625|Secondary|Left Ventricular Internal Diameter End Diastole (LVIDd)|LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.|At Baseline and 12 Months|A total of 40 patients were included in analysis because 5 patients died prior to the 12-month visit,1 patient missed the 12-month visit,3 patients had missing LVIDd at either baseline,the 12-month visit,or both time points & 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||cm||Standard Deviation|Mean
2692496|NCT01301625|Secondary|Left Ventricular Internal Diameter End Diastole (LVIDd)|LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.|At Baseline and 30 Days|A total of 67 patients had paired left ventricular internal diameter in diastole (LVIDd) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 5 patients had missing LVIDd at either baseline, the 30-day visit, or both time points.|||cm||Standard Deviation|Mean
2692497|NCT01301625|Secondary|Left Ventricular Internal Diameter End Diastole (LVIDd)|LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.|At Baseline and Discharge (≤7 days of index procedure)|A total of 72 patients had paired left ventricular internal diameter in diastole (LVIDd) measurements at both baseline and discharge. Six patients had missing LVIDd at either baseline, discharge, or both time points.|||cm||Standard Deviation|Mean
2692498|NCT01301625|Secondary|Number of Participants With MR Severity|"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe."|12 months|Mitral regurgitation severity is available for 42 patients at 12 months. Five patients died prior the 12-month visit, 1 patient missed the 12-month visit, 1 patient had missing MR severity at 12 months, and finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||Participants|||Count of Participants
2692651|NCT01300767|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692499|NCT01301625|Secondary|Number of Participants With MR Severity|"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe."|6 months|Mitral regurgitation severity is available for 60 patients at 6 months. Four patients died prior the 6-month visit, 1 patient missed the 6-month visit, 1 patient had missing MR severity at 6 months, and finally 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.|||Participants|||Count of Participants
2692500|NCT01301625|Secondary|Number of Participants With MR Severity|"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe."|30 days|Mitral regurgitation severity is available for 69 patients at 30 days. Six patients missed the 30-day visit and 3 patients had not evaluated for MR severity at 30 days.|||Participants|||Count of Participants
2692501|NCT01301625|Secondary|Number of Participants With MR Severity|"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe."|At discharge (≤7 days of index procedure)|Mitral regurgitation severity is missing in 4 patient at Discharge.|||Participants|||Count of Participants
2692502|NCT01301625|Secondary|Number of Participants With MR Severity|"Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.~MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe."|Baseline|Mitral regurgitation severity is missing in 1 patient at Baseline.|||Participants|||Count of Participants
2692503|NCT01301625|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).|At Baseline and 12 months|A total of 40 patients included in analysis population because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 3 patients had missing LVEF at either baseline, the 12-month visit, or both time points and 29 patients 12-month visits were either expected/not due at the time that the ANZ trial was terminated.|||percent||Standard Deviation|Mean
2692504|NCT01301625|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).|At Baseline and 30 Days|A total of 67 patients had paired left ventricular ejection fraction (LVEF) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 5 patients had missing LVEF at either baseline, the 30-day visit, or both time points.|||percent||Standard Deviation|Mean
2692505|NCT01301625|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).|At Baseline and Discharge (≤7 days of index procedure)|A total of 73 patients had paired left ventricular ejection fraction (LVEF) measurements at both baseline and discharge. Five patients had missing LVEF at either baseline, discharge, or both time points.|||percent||Standard Deviation|Mean
2692506|NCT01301625|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|At Baseline and 12 months|Of total 78 subjects, 37 patients were analyzed because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 6 patients had missing LVESV at either baseline, the 12-month visit, or both time points, and finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||ml||Standard Deviation|Mean
2692507|NCT01301625|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|At Baseline and 30 Days|A total of 61 patients had paired left ventricular end systolic volume (LVESV) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 11 patients had missing LVESV at either baseline, the 30-day visit, or both time points.|||ml||Standard Deviation|Mean
2692508|NCT01301625|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|At Baseline and Discharge (≤7 days of index procedure)|A total of 65 patients had paired left ventricular end systolic volume (LVESV) measurements at both baseline and discharge. Thirteen patients had missing LVESV at either baseline, discharge, or both time points.|||Milliliter||Standard Deviation|Mean
2692652|NCT01300767|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692509|NCT01301625|Secondary|Left Ventricle End Diastolic Volume (LVEDV)|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|At Baseline and 12 months|A total of 41 patients were excluded from total analysis population as 5 patients died, 1 patient missed the 12-month visit, 6 patients had missing LVEDV at either baseline, the 12-month visit, or both time points, and finally 29 subjects 12-month visits were either expected or not due at the time that the ANZ trial was terminated.|||ml||Standard Deviation|Mean
2692510|NCT01301625|Secondary|Left Ventricle End Diastolic Volume (LVEDV)|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|At Baseline and 30 Days|A total of 61 patients had paired left ventricular end diastolic volume (LVEDV) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 11 patients had missing LVEDV at either baseline, the 30-day visit, or both time points.|||ml||Standard Deviation|Mean
2692511|NCT01301625|Secondary|Left Ventricle End Diastolic Volume (LVEDV)|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|At Baseline and Discharge (≤7 days of index procedure)|A total of 65 patients had paired left ventricular end diastolic volume (LVEDV) measurements at both baseline and discharge. Thirteen patients had missing LVEDV at either baseline, discharge, or both time points.|||Milliliters||Standard Deviation|Mean
2692512|NCT01301625|Secondary|Total Contrast Volume|This is one of the Device and Procedure-Related Endpoints.|At day 0 (on the day of index procedure)|Total volume of contrast was not available for 5 patients.|||Milliliters||Standard Deviation|Mean
2692513|NCT01301625|Secondary|Fluoroscopy Duration|This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure.|At day 0 (on the day of index procedure)|Fluoroscopy duration was not available for 3 patient.|||Minutes||Standard Deviation|Mean
2692514|NCT01301625|Secondary|Device Time|This is one of the Device and Procedure-Related Endpoints. Device Time is defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter. Device Time is shorter in duration than Procedure Time because it does not include the time required to perform transseptal access into the left atrium.|At day 0 (on the day of index procedure)|Device time was not available for 1 patient.|||Minutes||Standard Deviation|Mean
2692515|NCT01301625|Secondary|Procedure Time|This is one of the Device and Procedure-Related Endpoints. Procedure Time is defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.|At day 0 (on the day of index procedure)|Procedure time was not available for 1 patient.|||Minutes||Standard Deviation|Mean
2692516|NCT01301625|Secondary|Number of Participants With Acute Procedural Success Rate|Defined as successful MitraClip implantation with resulting MR of 2+ or less.|At day 0 (on the day of index procedure)||||Participants|||Count of Participants
2692517|NCT01301625|Secondary|Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted|This is one of the Device and Procedure-Related Endpoints. Implant Rate is defined as the rate of successful delivery and deployment of MitraClip device implant(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.|Day 0 (On the day of procedure)||||Participants|||Count of Participants
2692518|NCT01301625|Primary|Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)|"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|12 months|A total of 32 patients were analyzed because 41 subjects had been censored and 5 had died at 12 months time frame.|||percentage of participants|||Number
2692519|NCT01301625|Primary|Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)|"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|6 months|"At the 6-month time point, 17 subjects had been censored and 4 had died, leaving 57 subjects at risk in the Kaplan-Meier freedom from mortality analysis at 6 months."|||percentage of participants|||Number
2692520|NCT01301625|Primary|Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)|"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|30 days|"Two patient were lost to follow-up at the 30-day time point and were not included in the at risk population in the Kaplan-Meier freedom from mortality analysis."|||percentage of participants|||Number
2692533|NCT01301456|Secondary|Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2||Baseline, Day 8, 15, 22, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mcmol/L||Standard Deviation|Mean
2692521|NCT01301625|Primary|Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)|"Clinical Endpoint.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|Baseline||||percentage of participants|||Number
2692522|NCT01301508|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of study medication and up to the end of study treatment (Day 42) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 42|Safety analysis population included all randomized participants with confirmed usage of the study medication.|||participants|||Number
2692523|NCT01301508|Other Pre-specified|Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42|ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Days 14, 42 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Days 14, 42 as compared to active lesion (ointment treated) were reported in this outcome measure.|Baseline (Day 1), Day 14, Day 42|ITT population included all randomized participants who received study medication.|||percentage of participants|||Number
2692524|NCT01301508|Primary|Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28|ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.|Baseline (Day 1), Day 28|ITT population included all randomized participants who received study medication.|||percentage of participants|||Number
2692525|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 42|ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 42|ITT population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
2692526|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 28|ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 28|ITT population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
2692527|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 14|ADSI score was used to measure the severity of participant's AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 14|ITT population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
2692528|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)|ADSI score was used to measure the severity of participant's atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Baseline (Day 1)|The intent-to-treat (ITT) population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
2692529|NCT01301456|Secondary|Number of Participant With Anti-Drug Antibodies (ADA): Stage 2||Day 1, 29 and 50|Safety population included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||participants|||Number
2692530|NCT01301456|Secondary|Number of Participants With Anti-Drug Antibodies (ADA): Stage 1||Day 1 and 29|Safety population included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||participants|||Number
2700991|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2692534|NCT01301456|Secondary|Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1||Baseline, Day 8, 15 and 29|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||micromole per liter (mcmol/L)||Standard Deviation|Mean
2692535|NCT01301456|Secondary|Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2|HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.|Baseline, Day 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent||Standard Deviation|Mean
2692536|NCT01301456|Secondary|Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2|A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.|Baseline, Day 30|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2692537|NCT01301456|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2||Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2692538|NCT01301456|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1||Baseline, Day 2, 4, 6, 15, 22 and 29|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2692539|NCT01301456|Secondary|Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3, 15, 24, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng*hr/mL||Standard Deviation|Mean
2692540|NCT01301456|Secondary|Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3 and 8|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng*hr/mL||Standard Deviation|Mean
2692541|NCT01301456|Secondary|Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3, 15, 24, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mU*hr/L||Standard Deviation|Mean
2692542|NCT01301456|Secondary|Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3 and 8|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milliUnit*hour per liter (mU*hr/L)||Standard Deviation|Mean
2692543|NCT01301456|Secondary|Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3, 15, 24, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg*hr/dL||Standard Deviation|Mean
2692544|NCT01301456|Secondary|Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC|Baseline, Day 3 and 8|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram*hour per deciliter (mg*hr/dL)||Standard Deviation|Mean
2692545|NCT01301456|Secondary|Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2||predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2692546|NCT01301456|Secondary|Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2692547|NCT01301456|Secondary|Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2||predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||mL||Geometric Coefficient of Variation|Geometric Mean
2692548|NCT01301456|Secondary|Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2692549|NCT01301456|Secondary|Apparent Clearance (CL/F) of PF-04856883: Stage 2|It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.|predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2692550|NCT01301456|Secondary|Apparent Clearance (CL/F) of PF-04856883: Stage 1|It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.|predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||milliliter per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
2692551|NCT01301456|Secondary|Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2|Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.|predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2692552|NCT01301456|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2692553|NCT01301456|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||hour||Full Range|Median
2692554|NCT01301456|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2692555|NCT01301456|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2692556|NCT01301456|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2692584|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
2692585|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)||||picogram/milliliter||Standard Deviation|Mean
2692557|NCT01301456|Primary|Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements|Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2692558|NCT01301456|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.|Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2692559|NCT01301456|Primary|Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)|ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2692560|NCT01301456|Primary|Number of Participants With Clinically Significant Physical Examination Findings|Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2692561|NCT01301456|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2692562|NCT01301391|Secondary|Progression-free Survival (PFS)|The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.|Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.|Evaluable patients|||Months||95% Confidence Interval|Median
2692563|NCT01301391|Secondary|Overall Survival|The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, and to the date in which the patients diagnosed with the disease are still alive. Kaplan-Meier estimates as percentage of patients alive.|Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.|Evaluable patients|||percentage of patients dead at 21 months|||Number
2692564|NCT01301391|Secondary|Duration of Response|Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.|Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.|Patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.|||Months|||Number
2692565|NCT01301391|Secondary|Disease Control Rate (ORR+SD Rate)|Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD > or = 6 weeks). The analysis was performed in the evaluable patient populations.|Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.|Evaluable patients|||Percentage of patients||95% Confidence Interval|Number
2692566|NCT01301391|Secondary|Objective Response Rate (ORR)|Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1). The analysis was performed in the evaluable population.|Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.|Evaluable population: the patient population consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and > or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.|||Percentage of patients||95% Confidence Interval|Number
2692586|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the non dominant hand 24 h after the procedure|24 h after the procedure||||participants|||Number
2692567|NCT01301391|Secondary|Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters|"The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment.~Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities were evaluated by considering the worst occurrence for each patient throughout the whole treatment period."|Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles.|All treated patients|||Participants|||Count of Participants
2692568|NCT01301391|Primary|Progression-free Survival Rate at 3 Months|The proportion of successes (i.e. patients alive and progression-free at 3 months since treatment start) out of the total number of evaluable patients.|3 months since treatment start|Evaluable patients, i.e., consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and > or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.|||Participants|||Count of Participants
2692569|NCT01301274|Secondary|ICU Length of Stay|ICU length of stay (in days)|180 days||||days||Standard Deviation|Mean
2692570|NCT01301274|Secondary|Mechanical Ventilation Free Days at 28 Day of Admission|mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.|first 28 day after starting mechanical ventilation||||days||Standard Deviation|Mean
2692571|NCT01301274|Secondary|Mortality at 28 Days|Mortality in both groups will be compared 28 days after admission|28 days after admission|The analysis was per intention to treat|||participants|||Number
2692572|NCT01301274|Primary|Serum Sodium Levels in Both Groups|Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion|first 48 hours||||mEq/L||Standard Deviation|Mean
2692573|NCT01301092|Secondary|)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.|||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2692574|NCT01301092|Secondary|Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.|||nanograms*hour/milliliter (ng*h/mL)||90% Confidence Interval|Geometric Mean
2692575|NCT01301092|Primary|Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.|||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2692576|NCT01301092|Primary|Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Geometric Mean
2692577|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
2692578|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 5h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-10 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5h after the procedure||||picogram/milliliter||Standard Deviation|Mean
2692579|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)||||picogram/milliliter||Standard Deviation|Mean
2692580|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
2692581|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
2692582|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)||||picogram/milliliter||Standard Deviation|Mean
2692583|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
2692590|NCT01301079|Secondary|Extension of Hyperalgesia|The 300-g filament was used 24 hours after the operation to induce a stimulus and delineate the extent of hyperalgesia from the periumbilical region. The stimulus was started outside the periumbilical region, where no pain sensation was reported, and continued every 0.5 cm until the 4 points of the periumbilical scar were reached (top, right side, left side, and bottom). The first point where the patient complained of pain was marked. If no pain sensation was reported, the stimulus was terminated 0.5 cm from the incision. The distance of each point from the surgical incision was measured, and the sum of the distances of the points was determined.|24 hours after the procedure||||centimeter||Standard Deviation|Mean
2692591|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure||||kilogram force/second||Standard Deviation|Mean
2692592|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the surgery)||||kilogram force/second||Standard Deviation|Mean
2692593|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure||||kilogram force/second||Standard Deviation|Mean
2692594|NCT01301079|Primary|Pain 24 Hours|The scale measure pain after 24 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|24 hours||||units on a scale||Standard Deviation|Mean
2692595|NCT01301079|Primary|Pain 18 Hours|The scale measure pain after 18 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|18 hours||||units on a scale||Standard Deviation|Mean
2692596|NCT01301079|Primary|Pain 12 Hours|The scale measure pain after 12 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|12 hours||||units on a scale||Standard Deviation|Mean
2692597|NCT01301079|Primary|Pain 6 Hours|The scale measure pain after 6 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|6 hours||||units on a scale||Standard Deviation|Mean
2692598|NCT01301079|Primary|Pain 240 Minutes|The scale measure pain after 240 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|240 minutes||||units on a scale||Standard Deviation|Mean
2692599|NCT01301079|Primary|Pain 210 Minutes|The scale measure pain after 210 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|210 minutes||||units on a scale||Standard Deviation|Mean
2692600|NCT01301079|Primary|Pain 180 Minutes|The scale measure pain after 180 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|180 minutes||||units on a scale||Standard Deviation|Mean
2692601|NCT01301079|Primary|Pain 150 Minutes|The scale measure pain after 150 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|150 minutes||||units on a scale||Standard Deviation|Mean
2692602|NCT01301079|Primary|Pain 120 Minutes|The scale measure pain after 120 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|120 minutes||||units on a scale||Standard Deviation|Mean
2692603|NCT01301079|Primary|Pain 90 Minutes|The scale measure pain after 90 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|90 minutes||||units on a scale||Standard Deviation|Mean
2692604|NCT01301079|Primary|Pain 60 Minutes|The scale measure pain after 60 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|60 minutes||||units on a scale||Standard Deviation|Mean
2692605|NCT01301079|Primary|Pain 30 Minutes|The scale measure pain after 30 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|30 minutes||||units on a scale||Standard Deviation|Mean
2692606|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the procedure)||||kilogram force/second||Standard Deviation|Mean
2692607|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the postoperative period (24h after the procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24h after the procedure||||gram||Standard Deviation|Mean
2692608|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)||||gram||Standard Deviation|Mean
2692653|NCT01300767|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692609|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the postoperative period (24 hours after procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24 hours after procedure||||gram||Standard Deviation|Mean
2692610|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)||||gram||Standard Deviation|Mean
2692611|NCT01301079|Secondary|Morphine Consumption Within 24 h||24 hours||||milligram||Standard Deviation|Mean
2692612|NCT01301079|Secondary|Time to First Morphine Supplementation||24 hours||||minutes||Full Range|Median
2692613|NCT01301066|Primary|Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks||12 weeks minus baseline|modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment|||mg/dL||Standard Deviation|Mean
2692614|NCT01301027|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months|The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2692615|NCT01301027|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months|The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2692616|NCT01301027|Primary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months|The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2692617|NCT01301027|Primary|Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months|The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2692618|NCT01301001|Secondary|Vulvodynia Pain|Overall vulvodynia pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). Pain was assessed daily during the last week of treatment. Daily scores were averaged.|Week 6 for each treatment arm||||units on a scale||95% Confidence Interval|Mean
2692619|NCT01301001|Secondary|Coital Pain|Coital pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever), assessed after each sexual intercourse event. The number of sexual intercourse events was averaged during final week of each treatment arm.|Week 6 of each treatment arm|Intent to treat|||units on a scale||95% Confidence Interval|Mean
2692620|NCT01301001|Primary|Tampon Test Pain Intensity|Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days).|Week 6 for each treatment arm|Intention to Treat|||units on a scale||95% Confidence Interval|Mean
2692621|NCT01300949|Primary|Contrast Sensitivity, Another Means of Testing Vision|Contrast Sensitivity, a vision measurement, is performed with the Spaeth Richmond Contrast Sensitivity (SPARCS) test. This is a computerized measurement of vision in the central and peripheral fields using black and white stripes. Black stripes decrease in contrast becoming fainter and harder to see until they blend with the white background. Measurements are assessed in five areas of the visual field . Test results are reported for each area ranging from 0 to 20 (0 means can't see stripes; 20 means sees all stripes). Results from all 5 areas are added making the total SPARCS score range 0 - 100 where 0 means poor vision and 100 means best vision. The test takes an average of 3 minutes per eye. The eye not being tested is covered with a patch.|duration of 1 eye exam, approximately 1 hour||||units on a scale||Standard Deviation|Mean
2692622|NCT01300923|Secondary|Brain-derived Neurotrophic Factor (BDNF)|BDNF is a protein that supports the survival of existing neurons and growth and differentiation of new neurons and synapses.|Screen and Week 10||||pg/mL||Standard Deviation|Mean
2692623|NCT01300923|Secondary|Peabody Picture Vocabulary|The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank.|Week 10||||units on a scale||Standard Deviation|Mean
2700992|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2692624|NCT01300923|Secondary|Vineland Adaptive Behavior Scales-II (VABS-II) Communication Domain|The VABS-II is a semi-structured interview designed to assess adaptive functioning in communication, daily living, socialization and motor skills. Recognizing that language is a major area of impairment in the study population, the Communication Domain (99 Items from 0-198), in particular the Expressive Subdomain (54 Items from 0-108) are of interest in this study. Items arranged in a developmental sequence are rated on a 3-point scale. Each item is scored from 0 (never performs the behavior) to 3 (usually performs the behavior independently). Higher scores indicate higher adaptive functioning. Differences between Baseline and Week 10 are used as an indicator of change.|Week 10||||units on a scale||Standard Deviation|Mean
2692625|NCT01300923|Secondary|ADHD Rating Scale 4th Edition|The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 10||||units on a scale||Standard Deviation|Mean
2692626|NCT01300923|Secondary|Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD|The Children's Yale-Brown Obsessive Compulsive Scales-Modified (CY-BOCS) is a 5-item, semi-structured clinician rating scale modified designed to rate the current severity of repetitive behavior in children and adolescents with PDD. Once the current repetitive behaviors are identified, they are separately rated on 5 items: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored on a 5-point scale form 0 (least symptomatic) to 4 (most symptomatic). The CY-BOCS yields a Total Score from 0 to 20 and is sensitive to change.|Week 10||||units on a scale||Standard Deviation|Mean
2692627|NCT01300923|Secondary|Social Responsiveness Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment|Week 10||||units on a scale||Standard Deviation|Mean
2692628|NCT01300923|Secondary|The Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist (ABC) is a 58-item rating scale used to assess maladaptive behaviors across five original subscales: Irritability (15 items from 0-45), Social Withdrawal (16 items from 0-48), Stereotypy (7 items from 0-21), Hyperactivity (16 items from 0-48), Inappropriate Speech (4 items from 0-12). Additionally, Social Avoidance, a newly developed four-item subscale (from 0-12) of the ABC that captures core social avoidance aspects of Fragile X Syndrome is reported. All items on the ABC are rated from 0 (not at all a problem) to 3 (the problem is severe in degree). Higher scores indicate greater maladaptive behaviors. Differences between Baseline and Week 10 are used as an indicator of change.|Week 10||||units on a scale||Standard Deviation|Mean
2692629|NCT01300923|Primary|Clinical Global Impression- Severity Scale (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Week 10||||units on a scale||Standard Deviation|Mean
2692630|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Miscellaneous (4 questions): range 0 - 48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692631|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Sexual function (2 questions): range 0 - 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692654|NCT01300741|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Percent likely to purchase|||Number
2692632|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Urinary (3 questions): range 0 - 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692633|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Gastrointestinal tract (3 questions): range 0 - 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692634|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Attention/Memory (3 questions): range 0 - 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692635|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Perception/Hallucinations (3 questions): range 0 - 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692636|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Mood/Cognition (6 questions): range 0 - 72"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692655|NCT01300741|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692656|NCT01300741|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692637|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Sleep/Fatigue (4 questions): range 0-48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692638|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:~Subdomain Cardiovascular (2 questions): range 0 - 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692639|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)|Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692640|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692641|NCT01300819|Primary|Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score|The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
2692642|NCT01300767|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks||||Percent likely to purchase|||Number
2692643|NCT01300767|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692644|NCT01300767|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692645|NCT01300767|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692646|NCT01300767|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks||||Units on a Scale||Standard Deviation|Mean
2692657|NCT01300741|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692658|NCT01300741|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692659|NCT01300741|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692660|NCT01300741|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692661|NCT01300741|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692662|NCT01300741|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692663|NCT01300741|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692664|NCT01300741|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2692665|NCT01300741|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses|||Units on a Scale||Standard Deviation|Mean
2692666|NCT01300728|Secondary|Mean Cognitive Performance at 24 Months|"24 month cognitive performance in treatment (IVIG/placebo) is measured by:~Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)~Scale from 0 to 85 (0 is best cognitive performance)~Score is the sum of 12 sub-scales.~Mini Mental State Exam (MMSE)~Scale from 0 to 30 (30 is best cognitive performance)~Score is the sum of 11 sub-scales.~Clinical Dementia Rating - Sum of Boxes (CDR-SB)~Scale is 0 to 18 (0 is best cognitive performance)~Score is the sum of 6 sub-scales"|24 month||||units on a scale||Standard Deviation|Mean
2692667|NCT01300728|Secondary|Mean Cognitive Performance at 12 Months|"12 month cognitive performance in treatment (IVIG/placebo) is measured by:~Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)~Scale from 0 to 85 (0 is best cognitive performance)~Score is the sum of 12 sub-scales.~Mini Mental State Exam (MMSE)~Scale from 0 to 30 (30 is best cognitive performance)~Score is the sum of 11 sub-scales.~Clinical Dementia Rating - Sum of Boxes (CDR-SB)~Scale is 0 to 18 (0 is best cognitive performance)~Score is the sum of 6 sub-scales"|12 months||||units on a scale||Standard Deviation|Mean
2692668|NCT01300728|Secondary|Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature|Mean ventricular volume (cubic centimeters) in patients with positive cerebrospinal fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer signature at 24 months following infusion|Baseline to 24 months following infusion||||cubic centimeters (cc)||Standard Deviation|Mean
2692669|NCT01300728|Secondary|Number of Participants Who Converted From Amnestic Mild Cognitive Impairment (a-MCI) to Alzheimer Disease (AD)|The National Institute of Neurological and Communicative Disorders and Stroke - Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria were proposed in 1984 by NINCDS-ADRDA criteria for diagnosing Alzheimer Disease and Clinical Dementia Rating (CDR) will be used to determine conversion from a-MCI to AD.|Baseline to 24 months||||participants|||Number
2692670|NCT01300728|Primary|Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI|"Change in ventricular volumetric as measured by MRI at baseline, 12, and 24 months following the first infusion of either 0.4 g/kg NewGam or 0.9% saline solution(placebo) every 14 days x 5.~Participants will also be classified as early MCI (EMCI) if baseline CDR-SB is less than 1.5, and late MCI (LMCI) if CDR-SB is greater than or equal to 1.5."|Baseline, 12, and 24 month MRI evaluation|"Annualized Percent Change in ventricular volume (APCV) at 12 and 24 months was computed as:~((12 or 24 month volume) - (Baseline volume))/(Baseline volume)/(Time (years) between Baseline and 12 or 24 month visit)"|||percent change per participant year||Standard Deviation|Mean
2692671|NCT01300650|Other Pre-specified|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||14 days|||||||
2692673|NCT01300650|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)|The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.|14 days||||units on a scale||Inter-Quartile Range|Median
2692674|NCT01300650|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|"The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.~Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope [day 14] - VE/VCO2 slope [baseline])"|14 days||||(unitless)||Inter-Quartile Range|Median
2692675|NCT01300650|Primary|Median Interval Change From Baseline in Peak VO2|"Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.~The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 [day 14] - Peak VO2 [baseline])"|14 days||||mL/kg/min||Inter-Quartile Range|Median
2692676|NCT01300624|Secondary|Communicative Effectiveness Ratings|"This questionnaire (Lomas et al, 1989) was provided to persons who communicated with the treatment participant regularly (e.g., a spouse). They rated how well the participant was able to perform on 16 common communication tasks (e.g., participating in a conversation over coffee). They rated each scenario along a line that spanned between the two extremes of ability, from not at all able to as able as before the stroke. The line was 100 mm. To score responses, the place where they bisected the line was measured. An average of their responses across the 16 questions was calculated."|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||units on a scale||Standard Deviation|Mean
2692677|NCT01300624|Secondary|Western Aphasia Battery|Standardized measure of aphasia severity|pre-treatment and post-treatment||||units on a scale||Standard Deviation|Mean
2692678|NCT01300624|Primary|Complete Utterances in Discourse|Sentence in discourse that were relevant to topic and syntactically correct|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||percentage of complete utterances||Standard Deviation|Mean
2692679|NCT01300624|Secondary|Verb Naming|Confrontation of 100 action pictures|pre-treatment and post-treatment||||percentage of correct naming||Standard Deviation|Mean
2692680|NCT01300624|Secondary|Noun Naming|Confrontation naming of 162 objects|pre-treatment and post-treatment||||percentage of correct naming||Standard Deviation|Mean
2692681|NCT01300624|Primary|Untrained Sentence Probes|Picture description with sentences containing untrained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||percentage of correct sentences||Standard Deviation|Mean
2692682|NCT01300624|Primary|Trained Sentence Probe|Picture description task that include trained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||percentage of correct sentences||Standard Deviation|Mean
2692683|NCT01300572|Secondary|Rates of Non-relapse Mortality|Transplant-related deaths within 100 days after transplant|Within the first 100 days following transplant||||Participants|||Count of Participants
2692684|NCT01300572|Secondary|Rates of Engraftment|Average number of days to ANC >= 500 after transplant|Up to 84 days post-transplant|Study participants with an ANC <= to 500 after transplant|||days||Standard Deviation|Mean
2692685|NCT01300572|Secondary|Rates of Donor Chimerism|Number of participants who has 100% donor chimerism within 100 days after transplant|Up to 100 days post-transplant|Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant.|||Participants|||Count of Participants
2692686|NCT01300572|Secondary|Rates of Acute GvHD|"Number of participants who developed acute GVHD post-transplant, aGVHD stages:~Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Up to 84 days post-transplant|Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant.|||Participants|||Count of Participants
2692687|NCT01300572|Secondary|Overall Survival|Number of participants who are still alive after transplant with or without disease.|Up to 5 years||||Participants|||Count of Participants
2692688|NCT01300572|Secondary|Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor|The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight.|Approximately day -20 to day -12 prior to transplant|All study participants who completed the study regimen.|||Gy||Standard Deviation|Mean
2692689|NCT01300572|Secondary|Duration of Remission|"Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, > 15% erythropoiesis and > 25% granulocytopoiesis~Normalization of blood counts (no blasts, platelets > 100000/mm3, granulocytes >1500/mm3)~No extramedullary disease.~Relapse Criteria:~After CR: >5% blasts in the bone marrow and/or peripheral blood~After partial remission (PR): increase of blasts cells in the marrow to >50% of those during PR~Extramedullary disease confirmed cytologically or histologically."|1 year|Study participants who relapsed after achieving complete remission after transplant.|||days||Full Range|Median
2692691|NCT01300572|Secondary|Achievement of Remission|"Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, > 15% erythropoiesis and > 25% granulocytopoiesis~Normalization of blood counts (no blasts, platelets > 100000/mm3, granulocytes >1500/mm3)~No extramedullary disease."|4 weeks after transplant|Study participants who completed the study regimen|||Participants|||Count of Participants
2692692|NCT01300572|Primary|The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.|The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.|Within the first 30 days following transplant|Study participants who completed the study regimen.|||Gy|||Number
2692693|NCT01300559|Primary|Hemoglobin Measurement g/dl|The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.|At the end of surgery|Based on pilot data, it was estimated that 29 patients per group would provide 90% power with = 0.01 to distinguish such a difference between groups. Therefore, the randomized study was planned for 60 patients.|||hemoglobin g/dl||95% Confidence Interval|Mean
2692694|NCT01300546|Secondary|Percent Change in Headache Days All Treatment Periods Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine headache days||Standard Deviation|Mean
2692695|NCT01300546|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Day 121||||scores on a scale||Standard Deviation|Mean
2692696|NCT01300546|Secondary|Migraine Disability Assessment Test (MIDAS)|"Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.||||scores on a scale||Standard Deviation|Mean
2692697|NCT01300546|Secondary|Percent Change of Doses of Study Medication|% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|12 Subjects did not take any triptans (Group A) or NSAIDs (Group B) during Baseline Period and were not included in Matched Pairs analysis of study medication taken.|||percent change of study medication||Standard Deviation|Mean
2692698|NCT01300546|Secondary|Doses of Study Medication|Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||doses of study medication||Standard Deviation|Mean
2692699|NCT01300546|Secondary|Migraine Attacks With 50% Reduction|Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||participants|||Number
2692700|NCT01300546|Secondary|Headache Days With Greater Than 50% Reduction|Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||participants|||Number
2692701|NCT01300546|Secondary|Migraine Duration From Time of Treatment to Pain Free|"% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine duration||Standard Deviation|Mean
2692702|NCT01300546|Secondary|Migraine Duration From Onset to Pain Free|Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine duration||Standard Deviation|Mean
2692703|NCT01300546|Secondary|Migraine Severity|Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine severity||Standard Deviation|Mean
2692704|NCT01300546|Secondary|Migraine Attacks|Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine attacks||Standard Deviation|Mean
2692705|NCT01300546|Primary|Percent Change of Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)||||percent change of headache days||Standard Deviation|Mean
2692706|NCT01300455|Secondary|Mean AHI|"Evaluation of the effect of multiple dose administration of suvorexant on~AHI as measured by polysomnography. The AHI is an overall index of OSA severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 1|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction.|||Events per hour||95% Confidence Interval|Least Squares Mean
2692707|NCT01300455|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Sleep stages were determined by polysomnography.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
2692708|NCT01300455|Secondary|Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%|"Evaluation of the percentage of the night in which SaO2 is less than 90%, less~than 85% and less than 80% following multiple dose administration of~suvorexant and placebo. Total sleep time is the total of all REM and non-REM sleep in a sleep episode."|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Percentage of Total Sleep Time||95% Confidence Interval|Mean
2692709|NCT01300455|Secondary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multidose dose suvorexant on mean SaO2 during total sleep time as measured by pulse oximetry. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
2692710|NCT01300455|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 13 days|All participants were included in the Safety Population.|||participants|||Number
2692711|NCT01300455|Primary|Number of Participants With an Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.|||participants|||Number
2692712|NCT01300455|Primary|Mean Apnea-Hypopnea Index (AHI)|"Evaluation of the effect of multiple dose administration of suvorexant on~AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 4|Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Events per hour||95% Confidence Interval|Least Squares Mean
2692713|NCT01300351|Secondary|Duration of Clinical Benefit|"Duration of clinical benefit (DoCB) will be evaluated only for patients who have CB, and is defined as the time from the date of randomisation until the date of disease progression or death from any cause, whichever is earlier.~Any patient who has not progressed or died by the date of DCO or who has been lost to follow up will be right censored at the date of their last evaluable disease assessment."|36 months|FAS|||months||Inter-Quartile Range|Median
2692803|NCT01299610|Secondary|Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086|Tmax was planned to be determined directly from the raw concentration-time data. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher.|Day 7, 14 and 21|Pharmacokinetics population. Tmax was not analysed because the plasma concentrations were not quantifiable.||||||
2702282|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.|Week 96|ITT-E Population|||Participants|||Number
2692714|NCT01300351|Secondary|Duration of Response|"Duration of response (DoR) will be evaluated only for patients who have an objective response, and is defined as the time from the date of first documentation of objective response (i.e., the initial visit at which CR or PR was recorded) until the date of disease progression or death due to any cause (whichever is earlier). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.~Any patient who has not progressed or died by the date of DCO, or who has been lost to follow up, will be right-censored at the date of their last disease assessment."|36 months|Evaluable for Response Set|||months||Inter-Quartile Range|Median
2692715|NCT01300351|Secondary|Clinical Benefit Rate|A clinical benefit (CB) responder is defined as a patient having a best overall response of either CR, PR or SD for at least 24 weeks per RECIST v1.1. As tumour assessments can occur ± 2 weeks of the specified time point, the CBR is defined as the proportion of patients in the FAS who have CB ≥ 22 weeks (or 154 days).|36 months|FAS|||patients|||Number
2692716|NCT01300351|Secondary|Objective Response Rate|The ORR is defined as the proportion of all randomized patients with measurable disease at baseline who have a best objective tumour response of either CR or PR per RECIST v1.1.|36 months|Evaluable for Response Set, included all patients in the FAS with measurable disease at baseline.|||patients|||Number
2692717|NCT01300351|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions, or death (by any cause in the absence of progression). The primary analysis for PFS was the log rank test stratified by last endocrine therapy received prior to fulvestrant (AO vs. AI). The treatment effect was estimated using the HR of 500 mg fulvestrant to 250 mg fulvestrant together with the corresponding 95% CI and p value.|36 months|FAS: all randomised patients and compared the treatment groups on the basis of randomised treatment, regardless of treatment actually received.|||months||Inter-Quartile Range|Median
2692718|NCT01300338|Primary|Mean Change in Diastolic Blood Pressure|Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months||||Millimeters of Mercury||95% Confidence Interval|Mean
2692719|NCT01300338|Primary|Mean Change in Systolic Blood Pressure|Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months||||Millimeters of Mercury||95% Confidence Interval|Mean
2692720|NCT01300286|Secondary|Cryoprecipitate Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||mL||Standard Deviation|Mean
2692721|NCT01300286|Secondary|Platelet Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||mL||Inter-Quartile Range|Median
2692722|NCT01300286|Secondary|Fresh Frozen Plasma Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||mL||Inter-Quartile Range|Median
2692723|NCT01300286|Secondary|Packed Red Blood Cell Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||units||Inter-Quartile Range|Median
2692724|NCT01300286|Primary|Fibrinogen Level Change|Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.|Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)||||mg/dl||Standard Deviation|Mean
2692725|NCT01300260|Other Pre-specified|Area Under the Insulin Concentration-time Curve (AUC)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUCG data.|||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
2692726|NCT01300260|Secondary|Insulin Maximum Concentration (Cmax)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.|||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
2692727|NCT01300260|Primary|Insulin Area Under the Curve (AUC) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 post dose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.|||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
2692804|NCT01299610|Secondary|Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X|Cmax was planned to be determined directly from the raw concentration-time data. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher.|Day 7, 14 and 21|Pharmacokinetic population was defined as participants in the All Subjects population for whom a pharmacokinetic sample was obtained and analyzed. Cmax was not analysed because the plasma concentrations were not quantifiable.||||||
2692728|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.|||picomole per liter (pmol/L)]||95% Confidence Interval|Geometric Mean
2692729|NCT01300260|Primary|Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.|||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
2692730|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.|||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
2692731|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Recovery|B-cell recovery was defined as CD19 >=0.07×10^9/L, where participants' CD19 were previously depleted. B-cell recovery was only considered possible when the participant had received the last dose of study treatment.|Follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population|||percentage of participants|||Number
2692732|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Depletion|B-cell depletion was defined as cluster of differentiation 19 (CD19) <0.07×10^9/L and could occur only after at least one dose of study drug had been administered.|Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population|||percentage of participants|||Number
2692733|NCT01300247|Secondary|Percentage of Participants Who Were Alive||Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.|||percentage of participants|||Number
2692734|NCT01300247|Secondary|Percentage of Participants Who Were Alive and Progression Free|Progressive disease assessed using IWCLL: >=50% increase in the absolute number of circulating lymphocytes to at least 5x10^9/L; Appearance of new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology.|Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.|||percentage of participants|||Number
2692735|NCT01300247|Secondary|Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines|DOR for participants with OR: time from first CR, CRi or PR to disease progression (DP), relapse, or death, assessed by the investigator. DP: >=50% increase in lymphocytes to at least 5x10^9/L;new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. CR:peripheral blood lymphocytes (PBL) <4x10^9/L; no lymphadenopathy; no hepatomegaly or splenomegaly (below relevant costal margin); no symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR: >=50% decrease in PBL, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi: met CR criteria, lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery.|From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 6 months)|Safety evaluable population.|||percentage of participants||95% Confidence Interval|Number
2692805|NCT01299610|Secondary|Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI|The PCI ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of PCI was reported are summarized. There were no values of PCI in vital signs parameters over the course of the study.|Up to Day 21|All subject population|||Participants|||Count of Participants
2692736|NCT01300247|Secondary|Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines|Objective response was defined as a complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR), as determined by investigator. CR:required peripheral blood lymphocytes <4x10^9/L; absence of lymphadenopathy; no hepatomegaly or splenomegaly by physical examination as determined by measurement below relevant costal margin; absence of disease/constitutional symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR:Greater than equal to (>=) 50% decrease in peripheral blood lymphocyte count, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi:met all CR criteria including confirmed lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. The 95% confidence interval (CI) was estimated by Clopper-Pearson method. The end of treatment response visit occurred 2-3 months after end of treatment.|Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months)|Safety evaluable population|||percentage of participants||95% Confidence Interval|Number
2692737|NCT01300247|Secondary|Half-Life of Obinutuzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
2692738|NCT01300247|Secondary|Volume of Distribution of Obinutuzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
2692739|NCT01300247|Secondary|Clearance of Obinutuzumab|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on C1D1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
2692740|NCT01300247|Secondary|Trough Plasma Concentration (Ctrough) of Obinutuzumab||Pre-dose on C1D1, C1D3, 8, 15, C2D1, C4D1, C6D1|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
2692741|NCT01300247|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab||Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
2692742|NCT01300247|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The pharmacokinetic (PK) variables could not be calculated as the PK samples were not collected accurately.||||||
2692743|NCT01300247|Primary|Number of Participants With Human Anti-Human Antibodies (HAHAs)||Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)|Safety evaluable population|||participants|||Number
2692744|NCT01300234|Secondary|Number of Participants in the Indicated Category for Renal Laboratory Abnormalities|"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade."|Up to Week 240|Safety Analysis Population|||Participants|||Number
2692745|NCT01300234|Secondary|Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus|The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, > 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point.|Up to Week 240|Safety Analysis Population|||Participants|||Number
2692746|NCT01300234|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)|TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase.|Up to Week 240|Safety Analysis Population|||participants|||Number
2692806|NCT01299610|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) of PCI|12-lead ECG was obtained. The standard ECG criteria of PCI were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) increase from Baseline in QTc > 60 msec 3) absolute PR Interval, <110 and >220 msec, 4) absolute QRS Interval, < 75 and >110 msec. The number of participants with PCI ECG findings at any visit during the treatment and follow-up were reported.|Up to Day 21|All subject population|||Participants|||Count of Participants
2692747|NCT01300234|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported.|Up to Week 240 treatment period and 24 weeks follow-up visit off treatment|Safety Analysis Population: All participants who received at least one dose of study medication and had at least one post-Baseline safety assessment|||Participants|||Number
2692748|NCT01300234|Secondary|Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240|"The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by >= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population."|Weeks 48, 96, 144, 192 and 240|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
2692749|NCT01300234|Secondary|Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240|"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population."|Week 96 to Week 240|ITT Population.|||Participants|||Number
2692750|NCT01300234|Secondary|Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48|"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population."|Week 24 to Week 48|ITT Population. Only those participants available at the indicated time points were assessed.|||Participants|||Number
2692751|NCT01300234|Secondary|Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240|HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240.|Weeks 24, 48, 96, 144, 192 and 240|ITT Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Number
2692752|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240|HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240.|Weeks 24, 48, 96, 144, 192 and 240|ITT Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Number
2692753|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240.|HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240.|Weeks 24, 48, 96, 144, 192 and 240|ITT Population. Only those participants with data available at specific time point were analyzed|||Participants|||Number
2692754|NCT01300234|Secondary|Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2.|Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS >=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 [best] to 14 [worst]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation.|Baseline; Week 48 and Week 240|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
2692755|NCT01300234|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline|"Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Baseline; Weeks 48, 96, 144, 192 and 240|ITT Population.|||Participants|||Number
2692775|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng/mL||Standard Deviation|Mean
2692756|NCT01300234|Secondary|Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240|"Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Baseline, Weeks 48, 96, 144, 192 and 240|ITT Population.|||log10 copies/mL||Standard Deviation|Mean
2692757|NCT01300234|Secondary|Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240|"The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Weeks 96, 144, 192, and 240|ITT Population|||Participants|||Number
2692758|NCT01300234|Primary|Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48|"The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Week 48|Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.|||Participants|||Number
2692759|NCT01300052|Secondary|Number of Participants With Local Tolerability Symptoms: Pruritus|Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2692760|NCT01300052|Secondary|Number of Participants With Local Tolerability Symptoms: Burning/Stinging|Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2692761|NCT01300052|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant's usual function b) moderate =AEs interfered to some extent with participant's usual function c) severe =AEs interfered significantly with participant's usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication.|||adverse events|||Number
2692762|NCT01300052|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication.|||participants|||Number
2692763|NCT01300052|Secondary|Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84|Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported.|Baseline (Day 1), Day 84|ITT population included all randomized participants who received the study medication. Missing data was imputed using LOCF method.|||percentage of body surface area||Standard Deviation|Mean
2692764|NCT01300052|Secondary|Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70|PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70.|Day 14, Day 28, Day 42, Day 56, Day 70|ITT population included all randomized participants who received the study medication.|||percentage of participants||95% Confidence Interval|Number
2692765|NCT01300052|Primary|Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84|PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.|Day 84|ITT population included all randomized participants who received the study medication. Missing data was imputed using last observation carried forward (LOCF) method.|||percentage of participants||95% Confidence Interval|Number
2692766|NCT01299961|Secondary|12 Month Change in Gray-scale Ultrasound (GSUS)|There were seven different joints in the hands and wrists evaluated to score the GSUS.|baseline, 12 months||||units on a scale||Standard Deviation|Mean
2692767|NCT01299961|Secondary|12 Month Change in Power Doppler Ultrasound (PDUS) Scores|There were seven different joints in the hands and wrists evaluated to score the PDUS.|baseline, 12 months|As stated previously|||units on a scale||Standard Deviation|Mean
2692768|NCT01299961|Primary|12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score|The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.|baseline, 12 months|Total of 19 patients completed 12 mos|||units on a scale||Standard Deviation|Mean
2692769|NCT01299909|Secondary|Perceived Stress Scale (PSS)|"The Perceived Stress Scale (PSS) is a self-report measure of perceived stress; the version used is a 10-item version. Each item is rated on a 0 to 4 scale with 0=Never and 4=Very Often. The minimum score is 0 and the maximum score is 40. Higher scores on the PSS reflect higher levels of perceived stress (a worse outcome).~More information on the PSS can be found in the following article:~Leung, D. Y., Lam, T. H., & Chan, S. S. (2010). Three versions of Perceived Stress Scale: Validation in a sample of Chinese cardiac patients who smoke. BMC Public Health, 10, 513-519"|24 weeks post-quit|Data are derived only from participants who completed all three study assessment visits|||units on a scale||Standard Deviation|Mean
2692770|NCT01299909|Secondary|Acceptance and Action Questionnaire (AAQ)|"The Acceptance and Action Questionnaire (AAQ) is a 9-item self-report measure of experiential avoidance. Each item is rated on a 1 to 7 scale with 1=Never true and 7=Always true; responses are summed and then divided by 9 (the number of items). The minimum score is 1 and the maximum score is 7. Higher scores equal greater levels of experiential avoidance or psychological inflexibility (a worse outcome).~More information on the AAQ can be found in the following two articles:~Hayes, S. C., Strosahl, K., Wilson, K. G., Bissett, R. T., Pistorello, J., Toarmino, D., et al. (2004). Measuring experiential avoidance: A preliminary test of a working model. The Psychological Record, 54(4), 553-578.~Boelen, P. A., & Reijntjes, A. (2008). Measuring experiential avoidance: Reliability and validity of the Dutch 9-item Acceptance and Action Questionnaire (AAQ). Journal of Psychopathology and Behavioral Assessment, 30, 241-251."|24 weeks post-quit|Data are derived only from participants who completed all three study assessment visits|||units on a scale||Standard Deviation|Mean
2692771|NCT01299909|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|"The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report questionnaire that assesses various components of mindfulness. Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). Higher scores on the FFMQ reflects a higher level of mindfulness (a better outcome).~More information on the FFMQ is available in the following two articles:~Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2006). Using self-report assessment methods to explore facets of mindfulness. Assessment, 13(1), 27-45, http://dx.doi.org/10.1177/1073191105283504.~Baer,R. A., Smith,G. T., Lykins, E., Button,D., Krietemeyer, J., Sauer, S., et al. (2008). Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment, 15(3), 329-342, http://dx.doi.org/10.1177/1073191107313003."|24 weeks post-quit|Data are derived only from participants who completed all three study assessment visits|||units on a scale||Standard Deviation|Mean
2692772|NCT01299909|Primary|Smoking Abstinence|Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.|24 weeks post quit day|analysis was conducted on all randomized participants|||participants|||Number
2692773|NCT01299896|Primary|Effectiveness of CTQ vs UC|We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.|Two (2) year period||||percentage of participants per arm|||Number
2692774|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
2692776|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng*hr/mL||Standard Deviation|Mean
2692777|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
2692778|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1|Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng/mL||Standard Deviation|Mean
2692779|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma|Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng*hr/mL||Standard Deviation|Mean
2692780|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
2692781|NCT01299805|Primary|Maximum Concentration of 5-HT in Cerobrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg/mL||Standard Deviation|Mean
2692782|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg*hr/mL||Standard Deviation|Mean
2692783|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
2692784|NCT01299805|Primary|Maximum Concentration of 5-HT in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg/mL||Standard Deviation|Mean
2692785|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg*hr/mL||Standard Deviation|Mean
2692786|NCT01299766|Secondary|Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year|The University of California Performance-based Skills Assessment (UPSA) was used as an objective test of accuracy with writing checks, making change, using a telephone, and scheduling a physician appointment (higher scores indicate better function). Possible scores range from 0 to 100.|24 months|The analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit.|||units per year||95% Confidence Interval|Mean
2692787|NCT01299766|Primary|Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)|A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory.|24 months|The primary analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit.|||Participants|||Count of Participants
2692788|NCT01299727|Secondary|Change From Baseline in Brain Magnetic Resonance Imaging (MRI) at Month 103|Brain MRI parameters include grey matter volume (GMV), white matter volume (WMV) and Intracranial cerebrospinal fluid Volume (ICSFV). Change from baseline in brain MRI at Month 103 was reported.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727). Here, the number of participants analyzed refer to the participants evaluable for this outcome measure at the specific categories.|||milliliter (mL)||Standard Deviation|Mean
2692789|NCT01299727|Secondary|Change From Baseline in Urine Glycosaminoglycan (GAG) Levels at Month 103|Change from baseline in Urine GAG at month 103 was recorded.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study. Data was not collected for this outcome as the trial was early terminated due to pre-specified efficacy criteria were not met.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2692790|NCT01299727|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Total Heparan Sulfate Levels at Month 103|Change from baseline in CSF total heparan sulfate at month 103 was recorded.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727). Here, the number of participants analyzed refer to the participants evaluable for this outcome measure at the specific categories.|||micromoles (μmol)||Standard Deviation|Mean
2692791|NCT01299727|Secondary|Change From Baseline in Vineland Adaptive Behavioral Scales Second Edition (VABS-II) at Month 103|VABS-II measured adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It was an instrument that supports the diagnosis of intellectual and developmental disabilities in participants. This test measured 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other four domains). Scoring is 'Usually' = 2, 'Sometimes'/Partially' = 1 or 'Never' = 0. The standard scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in adaptive functioning, communication, daily living skills, socialization and motor skills domains were reported here. The range for individual standard scores is 20-160.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727). Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.|||Score on a scale||Standard Deviation|Mean
2692792|NCT01299727|Secondary|Change From Baseline in Developmental Quotient (DQ) Using Bayley Scales of Infant Development Third Edition (BSID-III) and Kaufman Assessment Battery for Children Second Edition (KABC-II) at Month 103|BSID-III was used to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers aged 0-42 months and consisted of a series of developmental play tasks. KABC-II was an individually administered measure of the processing and reasoning abilities of children and adolescents between the ages of 3 and 18 years and an alternative to BSID-III. Raw scores of successfully completed items are converted to scale scores and to composite scores. The mean composite score is 100 and the standard deviation (SD) is 15. The DQ was a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0-100). A positive value indicates improvement in health and cognition.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727). Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.|||Score on a scale||Standard Deviation|Mean
2692802|NCT01299610|Secondary|Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086|The area under the plasma concentration-time curve to the last quantifiable concentration (AUC[0-t]) and area under the plasma concentration-time curve over the dosing interval (AUC[0-tou]) was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher.|Day 7, 14 and 21|Pharmacokinetics population. AUC was not analyzed because the plasma concentrations were not quantifiable.||||||
2692936|NCT01298778|Primary|Severity of Acute Pain|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.|24 hour||||mm||Standard Deviation|Mean
2692793|NCT01299727|Secondary|Change From Baseline in Bayley Scales of Infant Development Third Edition (BSID-III)/Kaufman Assessment Battery for Children Second Edition (KABC-II) Age-Equivalent Scores at Month 103|BSID-III was used to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers aged 0-42 months and consisted of a series of developmental play tasks. KABC-II was an individually administered measure of the processing and reasoning abilities of children and adolescents between the ages of 3 and 18 years and an alternative to BSID-III. Raw scores were converted to age--equivalent scores to measure ability, skill, and knowledge, expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound ). A positive value indicates improvement. The BSID--III and KABC--II age--equivalent scores were based on the cognitive domain and average non-verbal age-equivalent score, respectively.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727). Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.|||Score on a scale||Standard Deviation|Mean
2692794|NCT01299727|Secondary|Change From Baseline in Bayley Scales of Infant Development Third Edition (BSID-III) at Month 103|BSID-III was used to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers aged 0-42 months and consisted of a series of developmental play tasks. Score ranges: Cognitive scale 0-91, Receptive communication 0-49, Expressive communication 0-48, Fine motor 0-66 and Gross motor 0-72. Higher values denote stronger skills and abilities in the domain, indicating better outcomes.|Baseline, Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727). Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.|||Score on a scale||Standard Deviation|Mean
2692795|NCT01299727|Primary|Number of Participants With Positive Anti-rhHNS Antibody Status in Cerebrospinal Fluid (CSF) by Recombinant Human Heparan N-Sulfatase (rhHNS)|Antibody titers were determined for the samples that tested positive for anti-rhHNS antibodies. Participants with positive anti-rhHNS antibody in CSF were reported|Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727).|||Participants|||Count of Participants
2692796|NCT01299727|Primary|Number of Participants With Postive Anti-rhHNS Antibody Status in Serum by Recombinant Human Heparan N-Sulfatase (rhHNS)|Antibody titers were determined for the samples that tested positive for anti-rhHNS antibodies. Participants with positive Anti-rhHNS antibody status in serum were reported.|Month 103|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727).|||Participants|||Count of Participants
2692797|NCT01299727|Primary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)|Any change in ECG assessments which were deemed to be clinically significant findings and abnormalities were recorded as TEAEs.|From start of study drug administration up to follow-up (Month 103)|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727).|||Participants|||Count of Participants
2692798|NCT01299727|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|Clinical laboratory assessments include hematology, serum chemistry including liver function tests, coagulation urinalysis and cerebrospinal fluid (CSF) were reported.|From start of study drug administration up to follow-up (Month 103)|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727).|||Participants|||Count of Participants
2692799|NCT01299727|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. TEAEs were defined as all AEs from the time of the surgery for first IDDD implantation or first dose of HGT-1410 in study HGT-SAN-055 (NCT01155778) to the data cutoff date, or 30 days after the date of the last dose or 2 weeks after the date of device explant if early termination occurred. Severity of an AE is determined by following definitions: Mild: No limitation of usual activities; Moderate: Some limitation of usual activities; Severe: Inability to carry out usual activities.|From start of study drug administration up to follow-up (Month 103)|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727).|||Participants|||Count of Participants
2692800|NCT01299727|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) And Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. Treatment-emergent Adverse events (TEAEs) were defined as all adverse events (AEs) from the time of the surgery for first IDDD implantation or first dose of HGT-1410 in study HGT-SAN-055 (NCT01155778) to the data cutoff date, or 30 days after the date of the last dose or 2 weeks after the date of device explant if early termination occurred. TEAEs included participants with any AE, any drug-related AE, any surgery-related AE, any IDDD-related AE, and any IT administration process-related AE, any SAE, any serious drug-related AE.|From start of study drug administration up to follow-up (Month 103)|Safety population consisted of all eligible participants from Study HGT-SAN-055 (NCT01155778) who agreed to participate in this extension study, HGT-SAN-067 (NCT01299727).|||Participants|||Count of Participants
2692801|NCT01299610|Secondary|Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis|A 4 millimeter (mm) punch skin biopsy was taken pre- and post-treatment (Day 1 and Day 21) from each of the 3 index lesions. The results were not analyzed for this outcome measure.|Day 1 and Day 22|Efficacy Population||||||
2692937|NCT01298765|Secondary|Investigator's Overall Satisfaction With Study Drug|Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.|Baseline to Week 52||||units on a scale||Standard Deviation|Mean
2692807|NCT01299610|Secondary|Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI)|Laboratory ranges of PCI represented as multiplier of lower limit of normal [LLN]; Multipliers of upper limit of normal (ULN). Laboratory ranges of PCI for white blood cell count (0.67×LLN; 1.82×ULN), neutrophil count (0.83×ULN), hemoglobin for male (1.03×ULN) and for female (1.13×ULN), hematocrit for male (1.02×ULN) for female (1.17×ULN), platelet count (0.67×LLN; 1.57), lymphocytes (0.81×LLN), albumin (0.86 ×LLN), calcium (0.91×LLN; 1.06×ULN), glucose (0.71×LLN; 1.41×ULN), potassium (0.86×LLN; 1.10×ULN), sodium (0.96×LLN; 1.03×ULN), aspartate amino transferase (>= 2x ULN), alanine transaminase (>=2x ULN), alkaline Phosphatase (>=2x ULN), total bilirubin (>=1.5x ULN). Only those parameters for which at least one value of PCI was reported are summarized. The number of participants with PCI hematology and clinical chemistry findings at any visit during the treatment and follow-up were reported.|Up to Day 21|All subject population|||Participants|||Count of Participants
2692808|NCT01299610|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Number of participants with AEs and SAEs were reported.|Upto Day 21|All Subjects Population was defined as all participants who had at least one application of placebo, GW870086X 0.2%, GW 870086X 2% or FP 0.05% cream.|||Participants|||Count of Participants
2692809|NCT01299610|Secondary|Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22|Three target lesions were selected and each of the 3 target lesions were assessed separately using the IGA. The IGA was carried out by a trained dermatologist and score ranged from 0 to 5. The detailed IGA scale is as: 0-Clear: No inflammatory signs of atopic dermatitis, 1- Almost clear: Just perceptible erythema and just perceptible apulation/infiltration, 2-Mild: Mild erythema and mild papulation/infiltration, 3-Moderate: Moderate erythema, and moderate papulation/infiltration, 4-Severe: Severe erythema and severe papulation/infiltration, 5-Very Severe: Very severe erythema, and very severe papulation/infiltration with oozing/crusting. The participant was considered as responder if each lesion at timepoint, IGA score reduced by 1 grade and improved from Baseline by 2 grades.|Days 2, 3, 7, 14 and 22|Efficacy population|||Participants|||Count of Participants
2692810|NCT01299610|Secondary|Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14|Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=> 1square centimeter in size) with a sum score of =>4 and =< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. may range from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 values TIS score.|Days 2, 3, 7, and 14|Efficacy Population|||Score on scale||Standard Error|Least Squares Mean
2692811|NCT01299610|Primary|Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22|Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=> 1square centimeter in size) with a sum score of =>4 and =< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. ranging from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 TIS score.|Baseline (Day 1) and Day 22|The Efficacy Population was defined as participants in the ‘All Subjects’ population with at least one post dose TIS assessment.|||Score on scale||Standard Error|Least Squares Mean
2692812|NCT01299584|Secondary|Number of Participants With the Indicated Unexpected Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.|24 hours|ITT Population|||participants|||Number
2692813|NCT01299584|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population|||participants|||Number
2692814|NCT01299584|Secondary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population|||participants|||Number
2692831|NCT01299454|Secondary|CLr for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2692815|NCT01299584|Primary|Number of Participants With an Unexpected Serious Adverse Event|A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.|24 hours|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments|||participants|||Number
2692816|NCT01299571|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|6 months|ITT Population|||participants|||Number
2692817|NCT01299571|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|6 months|ITT Population|||participants|||Number
2692818|NCT01299571|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|6 months|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments|||participants|||Number
2692819|NCT01299480|Other Pre-specified|Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer||1 month after Injection 2, 3, 4|Results were not reported because a decision was made a priori that, although the fold rise outcome measure will still be performed, it will not be performed as a secondary outcome measure. Therefore it was moved from a secondary outcome measure in an earlier protocol version to an exploratory outcome measure in the final protocol.||||||
2692820|NCT01299480|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Injection 1, 1 Month after Injection 2, 3, 4||||percentage of participants|||Number
2692821|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ||Before Injection 1, 1 Month after Injection 2, 3, 4||||percentage of participants|||Number
2692822|NCT01299480|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)||Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4||||titer||95% Confidence Interval|Geometric Mean
2692823|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants||1 month after Injection 4||||percentage of participants|||Number
2692824|NCT01299480|Primary|Percentage of Participants Reporting At Least 1 Adverse Event (AE)||Injection 1 up to 1 month after Injection 4|Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.|||percentage of participants|||Number
2692825|NCT01299480|Primary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants||1 month after Injection 4||||percentage of participants|||Number
2692826|NCT01299454|Secondary|Incidence of Suicidality, Suicidal Behaviour or Suicidal Ideation as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The Baseline version of the C-SSRS was administered at Screening. The Since Last Visit version of the C-SSRS was administered on Day 1 at predose and on Days 4 and 7.|Day 1, Day 4, Day 7|Suicidality, suicidal behaviour or suicidal ideation are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participants|||Number
2692827|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Serum Chemistry, Hematology and Urinalysis Parameters.|Hematology, serum chemistry, and urinalysis, including prothrombin time, international normalized ratio, partial thromboplastin time, and activated partial thromboplastin time, were completed at Screening, Day -1, Day 3 (48 hours postdose), and Day 8 (168 hours postdose)/ET.|Day -1 to Day 8|The abnormal values of laboratory values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participant|||Number
2692828|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Parameters.|Electrocardiograms were performed at Screening, Day -1, and Day 1 at predose (in triplicate; within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Standard 12-lead ECGs were performed after the subject was supine and at rest for ≥ 10 minutes prior to the ECG.|Day-1 to Day 8|The abnormal values of ECG values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participants|||Number
2692829|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Vital Signs Parameters.|Vital signs (including blood pressure, heart rate, temperature, and respiratory rate) were assessed at Screening, Day -1, Day 1 at predose (within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Blood pressure and heart rate were taken with the subject in the supine (performed first), sitting, and standing|Day -1 to Day 8|The abnormal values of vital signs values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participants|||Number
2692830|NCT01299454|Secondary|Number of Adverse Events (AEs) Reported|AEs were captured for all participants from the time the ICF was signed until the end of the study|From the time the Informed Consent Form was signed, throughout the 8 day study up to 30 days after study drug administration.|Participants who received at least one dose of study drug were included in the safety analysis.|||Events|||Number
2692832|NCT01299454|Secondary|fe,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||% metabolite excreted in urine||Standard Deviation|Mean
2692833|NCT01299454|Secondary|Ae,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng||Standard Deviation|Mean
2692834|NCT01299454|Secondary|t1/2,z for DM-3411 Metabolite|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The t1/2,z was determined as (ln2)/λz."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Standard Deviation|Mean
2692835|NCT01299454|Secondary|Tmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Tmax is the time taken to reach highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Full Range|Median
2692836|NCT01299454|Secondary|Cmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Cmax is the highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
2692837|NCT01299454|Secondary|AUC∞ for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The AUC∞ were estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2692838|NCT01299454|Secondary|AUCt for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)~The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2692839|NCT01299454|Secondary|Fraction of Systemically Available Brexpiprazole Excreted Into the Urine (fe,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose..~The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||% of drug in urine||Standard Deviation|Mean
2692840|NCT01299454|Secondary|Cumulative Amount of Brexpiprazole Excreted Into the Urine (Ae,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng||Standard Deviation|Mean
2692841|NCT01299454|Secondary|Renal Clearance (CLr) of Brexipiprazole|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2692842|NCT01299454|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The t1/2,z was determined as (ln2)/λz.~Terminal-phase elimination half-life is the time measured for the plasma concentration to decrease by one half."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Standard Deviation|Mean
2692843|NCT01299454|Secondary|Apparent Unbound Clearance of Brexpiprazole From Plasma After Extravascular Administration (CLu/F)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The value of CLu/F (brexpiprazole only) was determined as dose normalized unbound area under the concentration-time curve from time zero to infinity (Dose/AUC∞,u)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2692844|NCT01299454|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu)|Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||% unbound drug in the urine||Standard Deviation|Mean
2692845|NCT01299454|Secondary|Apparent Clearance of Brexpiprazole From Plasma After Extravascular Administration (CL/F)|"The value of CL/F (brexpiprazole only) was determined as Dose/AUC∞.~Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2692880|NCT01299285|Primary|Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces||Baseline up to 120 hours|Participants who took study drug.|||percentage of total radioactivity||Standard Deviation|Mean
2692846|NCT01299454|Secondary|Time to Cmax of Brexiprazole (Tmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.~Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Full Range|Median
2692847|NCT01299454|Secondary|Maximum Plasma Concentration of Brexpiprazole (Cmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Cmax is the highest measured concentration of the drug during the dosing interval.~Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
2692848|NCT01299454|Secondary|Area Under the Concentration Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).~The AUC∞ was estimated using the linear trapezoidal rule"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2692849|NCT01299454|Secondary|Area Under the Curve of Brexpiprazole Calculated to the Last Observable Concentration at Time t (AUCt)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2692850|NCT01299454|Primary|Unbound Maximum Plasma Concentration of Brexpiprazole (Cmax,u)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Cmax,u is the highest measured unbound plasma concentration during the dosing interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
2692851|NCT01299454|Primary|Unbound Brexpiprazole AUC Calculated From Time Zero to Infinity (AUC∞,u)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2692852|NCT01299454|Primary|Unbound Brexpiprazole Area Under the Concentration Time Curve (AUC) Calculated to the Last Observable Concentration at Time t (AUCt,u)|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/Early termination (ET).|Day 1 to Day 8|Pharmacokinetics (PK) set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||nanograms.hours/mL (ng*h/mL)||Standard Deviation|Mean
2692853|NCT01299389|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2692854|NCT01299389|Secondary|Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2692855|NCT01299389|Secondary|Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2692856|NCT01299389|Secondary|Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28, higher score indicates greater severity.|Baseline and Week 13 or early discontinuation (ED)|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2692881|NCT01299272|Secondary|Change From Baseline in Pulse Rate up to Week 20 (Open-label Period)|Pulse measurements were collected when the participant was in a sitting position.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||beats per minute (bpm)||Standard Deviation|Mean
2692857|NCT01299389|Secondary|Participants With Response to the Treatment as Per PANSS Total Score.|Participants with response were defined as those participants who shows 30 percent or more and 20 percent or more reduction in PANSS total score.|up to Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||participants|||Number
2692858|NCT01299389|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Full Range|Median
2692859|NCT01299389|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|Full Analysis Set (FAS) population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Deviation|Mean
2692860|NCT01299376|Secondary|Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
2692861|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during extension period.|||Percentage of Participants|||Number
2692862|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
2692863|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
2692864|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
2692865|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
2692938|NCT01298765|Secondary|Subjects Overall Satisfaction With Study Drug|Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.|Baseline to Week 52||||units on a scale||Standard Deviation|Mean
2692866|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
2692867|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
2692868|NCT01299376|Primary|Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
2692869|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
2692870|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
2692871|NCT01299376|Primary|Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
2692872|NCT01299285|Secondary|Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma||Baseline up to 24 hours|Participants who took study drug.|||percentage of total radioactivity|||Number
2692873|NCT01299285|Secondary|Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces|Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report.|Baseline up to 72 hours|Participants who took study drug.|||percentage of dose|||Number
2692874|NCT01299285|Secondary|Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine|Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report.|Baseline up to 48 hours|Participants who took study drug.|||percentage of dose|||Number
2692875|NCT01299285|Secondary|Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)||Baseline up to 48 hours|Participants who took study drug.|||hour||Full Range|Median
2692876|NCT01299285|Secondary|Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)||Baseline up to 48 hours|Participants who took study drug.|||nanomole-equivalents/milliliter||Geometric Coefficient of Variation|Geometric Mean
2692877|NCT01299285|Secondary|Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)||Baseline up to 48 hours|Participants who took study drug.|||nanomoles/liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2692878|NCT01299285|Secondary|Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]||Baseline up to 48 hours|Participants who took study drug.|||hour*nanomole-equivalents/kilogram||Geometric Coefficient of Variation|Geometric Mean
2692879|NCT01299285|Secondary|Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]||Baseline up to 48 hours|Participants who took study drug.|||hour*nanomoles/liter(h*nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2692882|NCT01299272|Secondary|Change From Randomization in Pulse Rate at Week 44 (Double-blind Randomized Withdrawal Period)|Pulse rate measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline and baseline-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2692883|NCT01299272|Secondary|Change From Baseline in Blood Pressure up to Week 20 (Open-label Period)|Blood pressure measurements were taken 3 times at each visit in a sitting position. The average of the 3 values was used for analysis.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2692884|NCT01299272|Secondary|Change From Randomization in Blood Pressure at Week 44 (Double-blind Randomized Withdrawal Period)|Blood pressure measurements were taken 3 times at each visit in a sitting position. The average of the 3 values was used for analysis. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline and baseline-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2692885|NCT01299272|Secondary|Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score at Week 20 (Open-label Period)|Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score is reported and ranges from 7 to 42, with higher scores indicating greater impairment.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692886|NCT01299272|Secondary|Change From Baseline in the Arizona Sexual Experiences (ASEX) Questionnaire up to Week 20 (Open-label Period)|Arizona Sexual Experiences (ASEX) Questionnaire is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each item is rated from 1 (extremely) to 6 (no/never). Possible total scores ranged from 5 to 30, with the higher scores indicating more sexual dysfunction.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692887|NCT01299272|Secondary|Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Open-label Period)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Baseline through Week 20|All participants who have non-missing values at baseline and at least one post-baseline value.|||participants|||Number
2692888|NCT01299272|Secondary|Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) Index Scores, Visual Analog Scale up to Week 20 (Open-label Period)|The EQ-5D, a health-related, quality-of-life instrument, contains 2 parts: a health status profile and a visual analog scale (VAS). The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These dimensions are converted into weighted health-state index scores according to United States (US) and United Kingdom (UK) population-based algorithms. The US and UK based index scores range from -0.11 to 1.0 (where a score of 1.0 indicates perfect health) and from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), respectively. The VAS consists of participants rating their current health state from 0 (worst imaginable health state) to 100 (best imaginable health).|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692889|NCT01299272|Secondary|Change From Week 8 in the Sheehan Disability Scale (SDS) Items up to Week 20 (Stabilization Open-label Period)|The Sheehan Disability Scale (SDS) is completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692890|NCT01299272|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Items up to Week 8 (Acute Open-label Period)|The Sheehan Disability Scale (SDS) is completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692891|NCT01299272|Secondary|Change From Week 8 in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score up to Week 20 (Stabilization Open-label Period)|The Fatigue Associated with Depression (FAsD) is a 13-item participant-rated scale. Items 1-6 ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Items 7-13 ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score is derived by taking the mean of Items 1-6. The impact subscale score is derived by taking the mean of applicable Items 7-13. The average score is the mean of applicable Items 1-13. Item 12 applies only to participants with a spouse or significant other and Item 13 applies to participants who had a job or who went to school.|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692892|NCT01299272|Secondary|Change From Baseline in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score up to Week 8 (Acute Open-label Period)|The Fatigue Associated With Depression (FAsD) is a 13-item participant-rated scale. Items 1-6 ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Items 7-13 ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score is derived by taking the mean of Items 1-6. The impact subscale score is derived by taking the mean of applicable Items 7-13. The average score is the mean of applicable Items 1-13. Item 12 applies only to participants with a spouse or significant other and Item 13 applies to participants who had a job or who went to school.|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692893|NCT01299272|Secondary|Change From Week 8 in the Clinical Global Impression of Severity (CGI-S) Scores up to Week 20 (Stabilization Open-label Period)|The Clinical Global Impression of Severity (CGI-S) instrument is used to record the severity of mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692894|NCT01299272|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Scores up to Week 8 (Acute Open-label Period)|The Clinical Global Impression of Severity (CGI-S) instrument is used to record the severity of mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692895|NCT01299272|Secondary|Change From Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores up to Week 20 (Stabilization Open-label Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'.|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692896|NCT01299272|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores up to Week 8 (Acute Open-label Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'.|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692897|NCT01299272|Secondary|Change From Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores up to Week 20 (Stabilization Open-label Period)|Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692898|NCT01299272|Secondary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores up to Week 8 (Acute Open-label Period)|Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2692916|NCT01299090|Primary|Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment|"Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study.~The measurement is for percentage of patients who showed improvement"|90 days post treatment||||percentage of participants|||Number
2693724|NCT01292304|Secondary|Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)|Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L|12 weeks||||participants|||Number
2692899|NCT01299272|Secondary|Change From Randomization in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score at Week 44 (Double-blind Randomized Withdrawal Period)|Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score is reported and ranges from 7 to 42, with higher scores indicating greater impairment. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline CPFQ total score and baseline CPFQ total score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692900|NCT01299272|Secondary|Change From Randomization in the Arizona Sexual Experiences (ASEX) Questionnaire at Week 44 (Double-blind Randomized Withdrawal Period)|Arizona Sexual Experiences (ASEX) Questionnaire is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each item is rated from 1 (extremely) to 6 (no/never). Possible total scores ranged from 5 to 30, with the higher scores indicating more sexual dysfunction. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline ASEX total score and baseline ASEX total score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692901|NCT01299272|Secondary|Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Double-blind Randomized Withdrawal Period)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions, which includes a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present during the period up through randomization. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Randomization through Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||participants|||Number
2692902|NCT01299272|Secondary|Change From Randomization in the EuroQol Questionnaire-5 Dimension (EQ-5D) Index Scores, Visual Analog Scale up to Week 44 (Double-blind Randomized Withdrawal Period)|The EQ-5D, a health-related, quality-of-life instrument, contains 2 parts: a health status profile and a visual analog scale (VAS). The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These dimensions are converted into weighted health-state index scores according to United States (US) and United Kingdom (UK) population-based algorithms. The US and UK based index scores range from -0.11 to 1.0 (where a score of 1.0 indicates perfect health) and from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), respectively. The VAS consists of participants rating their current health state from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) model with main effects of treatment, country, and baseline score.|Randomization, up to Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
2692903|NCT01299272|Secondary|Change From Randomization in the Sheehan Disability Scale (SDS) Items at Week 44 (Double-blind Randomized Withdrawal Period)|The Sheehan Disability Scale (SDS) is completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692904|NCT01299272|Secondary|Change From Randomization in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score at Week 44 (Double-blind Randomized Withdrawal Period)|The FAsD is a 13-item participant-rated scale. Items 1-6 ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Items 7-13 ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score is derived by taking the mean of Items 1-6. The impact subscale score is derived by taking the mean of applicable Items 7-13. The average score is the mean of applicable Items 1-13. Item 12 applies only to participants with a spouse or significant other and Item 13 applies to participants who had a job or who went to school. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692932|NCT01298778|Secondary|Incidence of Depression|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.|2 months||||Participants|||Count of Participants
2692905|NCT01299272|Secondary|Change From Randomization in the Clinical Global Impression of Severity (CGI-S) Scores at Week 44 (Double-blind Randomized Withdrawal Period)|The Clinical Global Impression of Severity (CGI-S) instrument is used to record the severity of mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline CGI-S score and baseline CGI-S score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692906|NCT01299272|Secondary|Change From Randomization in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores at Week 44 (Double-blind Randomized Withdrawal Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline subscale score and baseline subscale score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692907|NCT01299272|Secondary|Change From Randomization in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores at Week 44 (Double-blind Randomized Withdrawal Period)|Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which includes terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline MADRS total score (individual item score) and baseline MADRS total score (individual item score)-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2692908|NCT01299272|Secondary|Percentage of Participants With Re-emergence of Depressive Symptoms (Double-blind Randomized Withdrawal Period)|Participants meeting any of the following criteria were determined as having major depressive disorder symptom re-emergence: 1) a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater ≥14 or a Clinical Global Impressions of Severity (CGI-S) increase of 2 or more points from Week 18 at 2 consecutive visits or 2) discontinuation due to lack of efficacy/worsening of depression/suicidality. The percentage of participants with re-emergence of depressive symptoms was calculated by dividing the number of participants who meet any of the criteria by the total number of participants analyzed, multiplied by 100. The MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity) to 60 (high severity). CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|Week 44|All randomized participants.|||percentage of participants|||Number
2692909|NCT01299272|Primary|Percentage of Participants Who Meet Criteria for Re-emergence of Depressive Symptoms Estimated by Kaplan-Meier Product Limit Method (Double-blind Randomized Withdrawal Period)|Participants meeting any of the following criteria were determined as having major depressive disorder symptom re-emergence: 1) a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater ≥14 or a Clinical Global Impressions of Severity (CGI-S) increase of 2 or more points from Week 18 at 2 consecutive visits or 2) discontinuation due to lack of efficacy/worsening of depression/suicidality. Time from randomization to the first visit at which the participant met the reemergence criteria was calculated. The percentage of participants who meet criteria was estimated using the Kaplan-Meier product limit method. The MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity) to 60 (high severity). CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|Randomization up to 44 weeks|All randomized participants.|||percentage of participants|||Number
2692910|NCT01299116|Secondary|Participant Attitudes to LARC vs SARC|Level of happiness with initial method (% distribution)|24 months||||Participants|||Count of Participants
2692911|NCT01299116|Secondary|Unintended Pregnancy|Intent-to-treat principles applied.|24 months||||Participants|||Count of Participants
2692912|NCT01299116|Primary|Contraceptive Method Discontinuation||24 months||||Participants|||Count of Participants
2692913|NCT01299103|Primary|Adverse Events|The rate of adverse events occurring in treatment subjects will be assessed.|90 days post treatment||||number of adverse events reported|||Number
2692914|NCT01299103|Primary|Fitzpatrick Wrinkle Assessment|Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease|change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.||||units on a scale, change in Fitzpatrick||Standard Deviation|Mean
2692915|NCT01299090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The rate of adverse events will be assessed throughout the duration of the study|90 days post treatment||||participants|||Number
2692933|NCT01298778|Secondary|Analgesic Consumption|total amount of analgesic consumption|24 hour||||mg||Inter-Quartile Range|Median
2692934|NCT01298778|Secondary|Pain|resting pain, worst pain|24 hour||||units on a scale, 0 -none, 100-worst||Inter-Quartile Range|Median
2692917|NCT01299077|Secondary|Visual Analogue Scale (VAS) Score|Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain.|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Scores on VAS||Standard Deviation|Mean
2692918|NCT01299077|Secondary|Japanese Orthopedic Association (JOA) Score|"Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item's scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition.~All of these items scores are combined for a total overall JOA score, which is range from 0 to 27."|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Scores on JOA||Standard Deviation|Mean
2692919|NCT01299077|Secondary|Safety Data During Triple Therapy.|Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Percentage of participants|||Number
2692920|NCT01299077|Secondary|Onset Time of Symptom Relief.|Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Average Days of Onset Time||Standard Deviation|Mean
2692921|NCT01299077|Primary|Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).|The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||percentage of participants|||Number
2692922|NCT01299038|Primary|Mean Change of Tissue Factor Bearing Microparticles|Comparison of plasma microparticle concentration between baseline and week 4|4 weeks||||microparticles per microliter||Standard Deviation|Mean
2692923|NCT01299025|Secondary|Change in the 12 Item Walking Scale From Day 1 to Day 42|The 12 item walking scale is a self-rating scale of walking limitations. The scale includes 12 items that each are scores from 1 to 5, where 5 is extremely limited. Scores are added and transformed to a scale from 0-100. 0 indicates no limitation and 100 extremely limited.|Measured at day 1 and day 42, before and after the training||||Scores on a scale||Standard Deviation|Mean
2692924|NCT01299025|Secondary|Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42|The ABC scale is a self-rating scale of balance activities in everyday Life. It includes 16 items. The patient rates his/her performance from 0-100. Score on each item are summed an divided by 16. Minimum score is 0 and maximum score 100. A higher score indicate higher confidence in ones balance and walking capacity.|Measured at day 1 (before training) and day 42 (after training)||||Scores on a scale||Standard Deviation|Mean
2692925|NCT01299025|Secondary|Change in Score on the Dynamic Gait Index From Day 1 to Day 42|The Dynamic Gait index consists of 8 items. Performance on each item is rated from 0 (severe impairment) to 3 (nomal performance). Minimum total score is 0 and maximum 24. Higher scores indicate better walking and balance performance.|Measured at day 1 (before training) and day 42 (after training)||||Scores on a scale||Standard Deviation|Mean
2692926|NCT01299025|Primary|Change in Timed Up and Go Test From Day 1 to Day 42|Change in seconds on the Timed Up and Go test (TUG). In the TUG test time is taken from rising from a chair, walking 3 meters, turning,walking back and sitting down.|Measured at day 1 (before the training period) and at day 42 (after the training period)||||seconds||Standard Deviation|Mean
2692927|NCT01298921|Secondary|Headache Relief and Pain Free|"Percentage of patients with no pain after 30 minutes of treatment~Headache relief and pain free at other time points (5 to 60 minutes)~Reduction of autonomic symptoms at 30 minutes~Any difference in treatment response between episodic and chronic cluster headache patients (if patient #'s allow)~Rescue medication use~Cluster headache recurrence by 24 hours post oxygen treatments~Patient satisfaction with treatment response compared with prior oxygen treatment if have utilized8.Likelihood of choosing this technique again to treat a cluster headache attack"|5 to 60 minutes|Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).||||||
2692928|NCT01298921|Primary|Reduction in Headache Pain|Headache response after 30 minutes of oxygen treatment. Headache response is defined as a reduction in headache pain intensity from moderate, severe, or very severe pain to mild or no pain.|30 minutes|Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).||||||
2692929|NCT01298778|Other Pre-specified|Emetic Symptoms|side effect potential with the increased dose of duramorph-percentage experiencing such symptoms|24hours|percentage of patients reporting emetic symptoms requiring treatment|||Participants|||Count of Participants
2692930|NCT01298778|Other Pre-specified|Pruritus|side effects-percentage of subjects requiring treatment|24 hours|percentage of patients with pruritis requiring treatment.|||Participants|||Count of Participants
2692931|NCT01298778|Secondary|Average Pain Over 24 Hours||24 hours|VAS pain score of 0=no pain at all up to 100 being worst pain imaginable.|||units on a scale||Standard Deviation|Mean
2702548|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 24 Months Follow-up|Incontinence- involuntary leakage of urine|Baseline and 24 months||||number of occurences||Standard Deviation|Mean
2692939|NCT01298765|Secondary|Treatment Satisfaction Questionnaire for Medication/Global Satisfaction|Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items|Baseline to Week 28||||units on a scale||Standard Deviation|Mean
2692940|NCT01298765|Secondary|Patient Global Impression of Change in Pain Intensity|Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'.|Baseline to Week 28||||units on a scale||Standard Deviation|Mean
2692941|NCT01298765|Primary|Change From Baseline in NRS Pain Intensity|The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.|Baseline up to approximately Week 52||||units on a scale||Standard Deviation|Mean
2692942|NCT01298700|Secondary|"Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding Conjunctival Hyperemia"|An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.|24 Months|Safety population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2692943|NCT01298700|Primary|Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.|24 Months|Safety population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2692944|NCT01298661|Secondary|"Third Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||bpm||Standard Deviation|Mean
2692945|NCT01298661|Secondary|"Second Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
2692946|NCT01298661|Secondary|"First Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
2692947|NCT01298661|Secondary|"Third Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||bpm||Standard Deviation|Mean
2692948|NCT01298661|Secondary|"Second Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
2692949|NCT01298661|Secondary|"First Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
2693263|NCT01296360|Primary|SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose||1 month post booster|Intent-to-treat Population: primary analysis population for the immunogenicity analyses; defined as all subjects randomized|||percentage of subjects||95% Confidence Interval|Number
2692950|NCT01298661|Secondary|"Third Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||% of hemoglobin||Standard Deviation|Mean
2692951|NCT01298661|Secondary|"Second Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter ."|First day or second day of the protocol (random) ,30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
2692952|NCT01298661|Secondary|"First Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
2692953|NCT01298661|Secondary|"Third Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||% of hemoglobin||Standard Deviation|Mean
2692954|NCT01298661|Secondary|"Second Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|,First day or second day of the protocol (random) 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
2692955|NCT01298661|Secondary|"First Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
2692956|NCT01298661|Secondary|"Third Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 2, the patient will step up down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||units on a scale||Full Range|Median
2692957|NCT01298661|Secondary|"Second Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute.The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
2692958|NCT01298661|Secondary|"First Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
2692959|NCT01298661|Secondary|"Third Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||units on a scale||Full Range|Median
2693093|NCT01298141|Primary|Number of Participants Who Reported Positive to Immunoglobulin E (IgE)|The IgE status was measured using ELISA. Number of participants who reported positive to IgE was reported.|Baseline (within 6 months prior to first dose) up to Week 129|Safety population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2692960|NCT01298661|Secondary|"Second Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
2692961|NCT01298661|Secondary|"First Six Minute Walk Test Exertion Perception"|"This test was conducted by the Rater 1, the subject walked as far as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
2692962|NCT01298661|Secondary|"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index)"|"It was evaluated only in the COPD patients. BODE index is a prognostic index used in COPD patients, it is a 0-10 scale, where lower values means better prognostic. It is composed by other commonly used evaluations tools in COPD, Forced Expiratory Volume in the First second (from spirometry); classification in the scale ranging from 0-3, Body-mass index, classification in the scale ranging from 0-1; Six-minute walk test distance, classification in the scale ranging from 0-3 and referred dyspnea, classification in the scale ranging from 0-3.~It was only used the total score (0-10)"|Second day|2 COPD were excluded since they did not appeared in the second day of evaluation. The other two populations were not verified, since the measure is specific for COPD patients|||units on a scale||Inter-Quartile Range|Median
2692963|NCT01298661|Secondary|"Third Six Minute Walk Test Distance"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||meter||Standard Deviation|Mean
2692964|NCT01298661|Secondary|"Second Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the first or second day of evaluation (random), 30 minutes after the first 6MWT.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||meter||Standard Deviation|Mean
2692965|NCT01298661|Secondary|"First Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||meter||Standard Deviation|Mean
2692966|NCT01298661|Primary|"Third Six Minute Step Test Performance"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||steps||Standard Deviation|Mean
2692967|NCT01298661|Primary|"Second Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the first or second day of evaluation (random), 30 minutes after the first 6MST.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||steps||Standard Deviation|Mean
2692968|NCT01298661|Primary|"First Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. The performance will be evaluated by the number of the steps."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||steps||Standard Deviation|Mean
2692969|NCT01298648|Secondary|Remission Rate at Week 4, Week 8, and Week 24|The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.|Baseline, Week 4, Week 8, and Week 24|Participants with available data at each time point.|||percentage of participants|||Number
2692970|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 24|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 24|Participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
2693094|NCT01298141|Primary|Number of Participants Who Reported Positive to Immunoglobulin A (IgA)|The IgA status was measured using enzyme-linked immunosorbent assay (ELISA). Number of participants who reported positive to IgA was reported.|Baseline (within 6 months prior to first dose) up to Week 129|Safety population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2692971|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 8|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 8|Participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
2692972|NCT01298648|Secondary|Improvement Rating by Investigator at Week 24|Overall response rating, according to investigator's subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.|Week 24||||percentage of participants|||Number
2692973|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 4|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 4|Participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
2692974|NCT01298648|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|24 weeks|Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.|||participants|||Number
2692975|NCT01298596|Secondary|Shedding of HIV-1 From the Cervix Between HIV-positive Women|Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up|3 weeks||||change in log10 cps HIV RNA per swab||95% Confidence Interval|Mean
2692976|NCT01298596|Primary|Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women|Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up|2 years||||Participants|||Count of Participants
2692977|NCT01298570|Secondary|Percentage of Patients With Severe Adverse Events|Toxicity Assessments were made according to NCI CTCAE v. 4.0 . Severe events (grades 3-4) that occurred in a higher percentage of regorafenib treated participants as compared to placebo are reported below.|3 years|All patients who received treatment|||percentage of participants|||Number
2692978|NCT01298570|Secondary|Drug Metabolism|To compare the pharmacokinetic (PK) profile of FOLFIRI between a subset of patients receiving regorafenib (ARM A) and patients receiving placebo (Arm B). The Area Under the Curve (AUC) levels of the irinotecan metabolite SN-38 were compared.|28 days|This objective was designed to only look at a small subset of participants (11 on each arm)|||AUC/dose=(ng/mL*h)/(mg/m^2)||Inter-Quartile Range|Median
2692979|NCT01298570|Secondary|Overall Survival (OS)|To compare overall survival (OS) between ARM A and ARM B. OS is defined as the time from randomization until death as a result of any cause.|5.5 years||||Months||Full Range|Median
2692980|NCT01298570|Secondary|Disease Control (DC) Rate|To compare Disease Control (DC) Rate (DC= CR + PR + SD) between ARM A and ARM B as defined via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and Stable Disease (SD) ), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years|Only evaluable participants (those who had RECIST measurements after baseline) were included in this analysis|||Participants|||Count of Participants
2692981|NCT01298570|Secondary|Overall Response(OR)Rate|To compare overall response (OR) rates (OR= CR + PR) between ARM A and ARM B as defined via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 years|Only evaluable participants (those who had RECIST measurements after baseline) were included in this analysis|||Participants|||Count of Participants
2692982|NCT01298570|Primary|Progression Free Survival (PFS)|To compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients failing one prior oxaliplatin-containing regimen for metastatic colorectal cancer. PFS is defined as the time from randomization until metastatic colorectal cancer (mCRC) progression or death as a result of any cause. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5.5 years||||Months||95% Confidence Interval|Median
2693264|NCT01296347|Secondary|Incidence of Side Effect, Vivid Dreams|The presence of vivid dreams recorded at the above time points|108 hours||||Participants|||Count of Participants
2692983|NCT01298544|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population|||Percentage of participants||95% Confidence Interval|Number
2692984|NCT01298544|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2692985|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Weeks 12 and 16|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||cm||Standard Deviation|Mean
2692986|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 8|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||cm||Standard Error|Least Squares Mean
2692987|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 4|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||cm||Standard Error|Least Squares Mean
2692988|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 16|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2692989|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 12|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2692990|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693009|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 4|The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2692991|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2692992|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Weeks 12 and 16|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2692993|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2692994|NCT01298531|Other Pre-specified|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2692995|NCT01298531|Other Pre-specified|Number of Participants With PASS at Weeks 4, 12 and 16|PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2692996|NCT01298531|Other Pre-specified|Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8|PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2692997|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16|MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2692998|NCT01298531|Other Pre-specified|Number of Participants With MCII at Weeks 4, 12 and 16|MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2693265|NCT01296347|Secondary|Incidence of Side Effect, Lightheaded|The presence of lightheaded recorded at the above time points|108 hours||||Participants|||Count of Participants
2692999|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8|MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2693000|NCT01298531|Other Pre-specified|Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693001|NCT01298531|Other Pre-specified|Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16|Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Tender joints||Standard Deviation|Mean
2693002|NCT01298531|Other Pre-specified|Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16|Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Swollen joints||Standard Deviation|Mean
2693003|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 16|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693004|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 12|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693005|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 8|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693006|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 4|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693007|NCT01298531|Other Pre-specified|Change From Baseline in PGA at Weeks 12 and 16|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693008|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 8|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693071|NCT01298362|Secondary|Percentage Change in Lumbar Spine Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
2693010|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693011|NCT01298531|Secondary|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693012|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693013|NCT01298531|Other Pre-specified|Change From Baseline in BASFI at Week 8|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693014|NCT01298531|Other Pre-specified|Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693015|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693016|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 8|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693017|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 4|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693018|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693019|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 8|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693020|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 4|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693021|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Weeks 12 and 16.|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693022|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Week 8|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693023|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693024|NCT01298531|Secondary|Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.|||Scores on a scale||Standard Error|Least Squares Mean
2693025|NCT01298531|Secondary|Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.|||Scores on a scale||Standard Error|Least Squares Mean
2693026|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693072|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.||Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
2693266|NCT01296347|Secondary|Incidence of Side Effect, Vomiting|The presence of vomiting recorded at the above time points|108 hours||||Participants|||Count of Participants
2693027|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Week 8.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693028|NCT01298531|Secondary|Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693029|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on scale||Standard Deviation|Mean
2693030|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Week 8.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693031|NCT01298531|Secondary|Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693032|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
2693033|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2693034|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
2693035|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2693036|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
2693037|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2693038|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.|Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
2693039|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Week 8.|Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
2693040|NCT01298531|Secondary|Change From Baseline in Mini BASDAI at Week 8 (AUC).|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.|||Unit on a scale * days||Standard Error|Least Squares Mean
2693041|NCT01298531|Secondary|Number of Participants Using NSAIDs at Week 8.|Participants who received NSAIDs at Week 8 were reported.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.|||Participants|||Number
2693042|NCT01298531|Secondary|Change From Baseline in BASDAI Score at Weeks 12 and 16.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.|||Units on a scale||Standard Deviation|Mean
2693043|NCT01298531|Secondary|Change From Baseline in BASDAI at Week 8|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693044|NCT01298531|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
2693045|NCT01298531|Secondary|Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.|The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Unit on a scale * days||Standard Error|Least Squares Mean
2693046|NCT01298531|Primary|Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 8|The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).|||Scores on a scale||Standard Error|Least Squares Mean
2693047|NCT01298518|Secondary|Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110|"Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.~AUC (0-24) was computed using the linear trapezoidal method."|24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value.|||ng*hr/mL||Standard Deviation|Geometric Mean
2693048|NCT01298518|Secondary|Time to Cmax (Tmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value.|||hr||Full Range|Median
2693049|NCT01298518|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value.|||ng/mL||Standard Deviation|Geometric Mean
2693050|NCT01298518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value.|||ng/mL||Standard Deviation|Geometric Mean
2693051|NCT01298518|Secondary|Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28|Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 12 to 16 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
2693052|NCT01298518|Secondary|Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28|Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 6 to 10 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
2693053|NCT01298518|Secondary|Change From Baseline in Fasting Net Triglycerides at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group.|||mg/dL||Standard Deviation|Mean
2693054|NCT01298518|Secondary|Change From Baseline in Fasting Insulin at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group.|||micro-IU/mL||Standard Deviation|Mean
2693055|NCT01298518|Secondary|Change From Baseline in Fasting Glucose at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group.|||mg/dL||Standard Deviation|Mean
2693056|NCT01298518|Secondary|Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||pg*hr/mL||Standard Deviation|Mean
2693057|NCT01298518|Secondary|Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||pg*hr/mL||Standard Deviation|Mean
2693267|NCT01296347|Secondary|Incidence of Side-effects, Nausea|The presence of nausea recorded at the above time points|108 hours||||Participants|||Count of Participants
2693058|NCT01298518|Secondary|Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||pmol*hr/L||Standard Deviation|Mean
2693059|NCT01298518|Secondary|Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
2693060|NCT01298518|Secondary|Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||ng*hr/mL||Standard Deviation|Mean
2693061|NCT01298518|Secondary|Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||micro-IU*hr/mL||Standard Deviation|Mean
2693062|NCT01298518|Secondary|Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28|APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.|Baseline (Day -1); 24 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group.|||mg/dL||Standard Deviation|Mean
2693063|NCT01298518|Primary|Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
2693064|NCT01298492|Secondary|Serum Trough Concentrations of PF-00547659 Versus Time|Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.|Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96|PK population included all enrolled participants who received at least 1 dose of investigational product and had data on at least 1 PK concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2693065|NCT01298492|Secondary|Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies|Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.|Baseline up to Week 96|The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2693066|NCT01298492|Primary|Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)|AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.|From start of study treatment up to Week 72 (Treatment Period)|The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2693067|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.||Month 1-6 (depending on duration of chemotherapy) and month 13-18|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
2693068|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion||Baseline and month 1-6 (depending on duration of chemotherapy)|Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion|||percentage of change||95% Confidence Interval|Mean
2693069|NCT01298362|Secondary|Bone Fracture Rate||During the 12 months of AI Therapy|All patients with available 12 month follow-up during AI treatment|||participants|||Number
2693070|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
2702549|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 12 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline and 12 months||||number of occurences||Standard Deviation|Mean
2693073|NCT01298362|Primary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy|"BMD was evaluated at lumbar spine (LS) and hip (HIP) with measurements taken before CT, before AI therapy and at the end of the 12 month followup period while on AI treatment. Dual Energy X-Ray Absorptiometry (DEXA scan) was used with all measurements performed with the Explorer absorptiometer produced by Hologic, Bedford, MA, USA in the same referral site in Athens, apart from two centres in other cities which used however the same absorptiometer model with identical software.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group."|Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with LS BMd measurements both at baseline and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
2693074|NCT01298323|Primary|Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.|The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.|12 months|Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.|||Percentage of days|months|Standard Deviation|Mean
2693075|NCT01298219|Secondary|Number of SBMs Per Week Overall|Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.|within 14 weeks|Intention to treat with data at Week 14|||SBMs/week||Standard Deviation|Mean
2693076|NCT01298219|Secondary|Number of SBMs Per Week at Week 12||at Week 12|Intention to treat with data at Week 12|||SBMs/week||Standard Deviation|Mean
2693077|NCT01298219|Secondary|Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation||within 48 hours post-dose|Intention to treat|||Participants|||Count of Participants
2693078|NCT01298219|Secondary|Number of SBMs Per Week at Week 8||at Week 8|Intention to treat with data at Week 8|||SBMs/week||Standard Deviation|Mean
2693079|NCT01298219|Primary|Number of Participants Classified as Treatment Responders Within 12 Weeks|Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.|12 weeks|Intention to treat|||Participants|||Count of Participants
2693080|NCT01298193|Secondary|Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2|"To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).~The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9)."|Up to day 6|During cycle 2, only 23 patients completed the FLIE questionnaire.|||score on a scale||95% Confidence Interval|Mean
2693081|NCT01298193|Secondary|Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2|"To determine the incidence of Nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).~The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Nausea on daily life. There are 9 items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9)."|Up to day 6|During cycle 2, only 23 patients completed the FLIE questionnaire.|||score on a scale||95% Confidence Interval|Mean
2693082|NCT01298193|Secondary|Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2|"To determine the total incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).~The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18)."|Up to day 6|During cycle 2, only 23 patients completed the FLIE questionnaire.|||score on a scale||95% Confidence Interval|Mean
2693083|NCT01298193|Secondary|Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1|"To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).~The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 vomiting-related items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9)."|Up to day 6|From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.|||score on a scale||95% Confidence Interval|Mean
2693084|NCT01298193|Secondary|Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1|"To determine the incidence of nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).~The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and vomiting on daily life. There are 9 nausea-related items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9)."|Up to day 6|From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.|||score on a scale||95% Confidence Interval|Mean
2693085|NCT01298193|Secondary|Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1|"To determine the incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).~The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18)."|Up to day 6|From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.|||score on a scale||95% Confidence Interval|Mean
2693086|NCT01298193|Secondary|Number of Participants With Treatment Related Adverse Events (AE) at Cycle 2|Events are related to the primary end point, they were collected only in the diary during the period of diary data collection (Day 1 to the morning of Day 6) for the cycle 2, unless they meet the definition of a serious adverse event.|Cycle 2, and average of 3 weeks|Of the 185 evaluable patients, 161 achieved CR, so who participated in this outcome were 24 patients who experienced non-complete response (NCR).|||Participants|||Count of Participants
2693087|NCT01298193|Secondary|Number of Participants With Complete Response (CR) in Cycle 2 for Patient Without Complete Response in Cycle 1|To evaluate in cycle 2 the efficacy of aprepitant (days 1, 2 and 3) as secondary prevention in patients without complete response in cycle 1. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.|Up to cycle 2, and average of 6 weeks|Of the 185 evaluable patients, 161 achieved CR, so who participated in this outcome were 24 patients who experienced non-complete response (NCR).|||Participants|||Count of Participants
2693088|NCT01298193|Primary|Number of Participants With Complete Response (CR)|Complete response is defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.|Up to 21 days after cycle 1 of chemotherapy treatment|27 patients were excluded from the main analysis: 16 received docetaxel and cyclophosphamide (TC) at a different dose from that in the protocol, 9 had received previous emetogenic chemotherapy and 2 withdrew study consent before receiving TC.|||Participants|||Count of Participants
2693089|NCT01298167|Primary|Visual Analog Scale (VAS)|"The Visual Analog or Analogue Scale (VAS)* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style.~The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound.~Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993~Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102~Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99"|3 months|Individuals' wounds were divided in half and then treated with both Cyanoacrylate and Fast Absorbing Gut Suture. Individuals were randomized as to which half of the wound (superior or inferior) would be treated by each of the methods.|||units on a scale||Standard Deviation|Mean
2693090|NCT01298141|Primary|Number of Participants Who Reported Positive to Neutralizing Antibody (NAb)|The NAb status was measured using enzyme activity inhibition assay. Number of participants who reported positive to NAb was reported.|Baseline (within 6 months prior to first dose) up to Week 285|Safety population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2693091|NCT01298141|Primary|Number of Participants Who Reported Positive to Anti-drug Antibody (ADA)|The ADA status was measured using ELISA and electrochemiluminescent (ECL) immunoassay. Number of participants who reported positive to ADA was reported.|Baseline (within 6 months prior to first dose) up to Week 285|Safety population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2693092|NCT01298141|Primary|Number of Participants Who Reported Positive to Immunoglobulin M (IgM)|The IgM status was measured using ELISA. Number of participants who reported positive to IgM was reported.|Baseline (within 6 months prior to first dose) up to Week 129|Safety population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2693095|NCT01298141|Primary|Number of Participants With Infusion-Related Reactions (IRR)|An IRR (also referred to as infusion-related adverse event [IRAE]) was defined as an AE that began either during the infusion or within 12 hours after the start of the infusion and was judged as possibly or probably related to study drug. The IRRs were classified based on the severity as Mild=No limitation of usual activities, Moderate=Some limitation of usual activities, Severe=Inability to carry out usual activities and Life-threatening=Immediate risk of death. The number of participants with infusion-related reactions was reported.|From the start of study treatment up to 30 days after the last dose of study drug administration (up to 320 weeks)|Safety Population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2693096|NCT01298141|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related.Treatment-emergent adverse events (TEAEs) were defined as those events which occurred or worsened in severity after first treatment with Replagal AF until 30 days after the last dose. A serious AE (SAE) was any AE occurred at any dose that resulted in death, life-threatening, hospitalization, prolongation of existing hospitalization, persistent or significant disability or incapacity and congenital anomaly or birth defect.|From the start of study treatment up to 30 days after the last dose of study drug administration (up to 320 weeks)|Safety Population included all participants who received at least one full or partial infusion of Replagal AF.|||Participants|||Count of Participants
2693097|NCT01298128|Primary|Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)|abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain|patients were followed for the duration of an in-vitro fertilization cycle- 2 months|70 patients were recruited and randomized. 53 patients completed the study. 11 patients did not then undergo an ivf cycle after recruitment. 6 patients withdrew from the study after recruitment.|||participants|||Number
2693098|NCT01298063|Secondary|Clinical Relevant Abnormalitites for Physical Examination, Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Adverse Event, Investigator's Global Tolerability|Clinical relevant abnormalitites for physical examination, vital signs, 12-lead electrocardiogramm (ECG), clinical laboratory test (including hematology, clinical chemistry, coagulation, urinalysis), adverse event, investigator's global tolerability. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 28 days after last administration of trial medication|Treated set|||participants|||Number
2693099|NCT01298063|Secondary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2693100|NCT01298063|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of the analyte in plasma|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2693101|NCT01298063|Primary|Area Under Curve From 0 to Infinity (AUC0-infinity)|AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|Pharmacokinetic (PK) analysis set includes all evaluable matched subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations. Group B1 was not included in the primary analysis set for comparison.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2693102|NCT01297985|Secondary|Coping Style|"Coping is measured via patient self-report using The Brief COPE Inventory (Carver, 1997), a 28-item instrument with 4-point Likert responses ranging from 1-I haven't been doing this at all to 4-I have been doing this a lot. This measure includes two subscales that assess participants' adaptive coping skills (e.g., planning and using emotional support to deal with problems) and maladaptive coping skills (e.g., self-blame and denial). Scoring involves computing the means for each subscale, with a minimum value of 1 and a maximum value of 4. Higher adaptive coping scores indicate a greater use of positive coping styles; higher maladaptive coping scores indicate a greater use of negative coping styles (in other words, lower maladative coping scores indicate a better outcome)."|Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)|"The Overall Number of Participants Analyzed reflects the number of participants at Time 1. Results are provided for the Maladaptive Coping Subcale."|||units on a scale||Standard Deviation|Mean
2693103|NCT01297985|Secondary|Patient Self-advocacy|"The ability to advocate for oneself with medical care providers is assessed via self-report using The Patient Self-Advocacy Scale (Brashers et al., 1999), an 18-item scale with a 5-point Likert response set ranging from strongly disagree to strongly agree. Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Scoring involves computing the mean scale score, so therefore values range from a minimum of 1 to a maximum of 5, with higher scores indicating a better outcome. Reported below are findings for the assertiveness sub-scale."|Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)|The Overall Number of Participants Analyzed reflects the number of participants at Time 1|||average score on a scale||Standard Deviation|Mean
2693140|NCT01297465|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."|||participants|||Number
2693104|NCT01297985|Secondary|Hopefulness|"Hopefulness is measured by the State Hope Scale (Snyder et al., 1991). Hopefulness as a cross-situational long-term trait is assessed via patient self-report using a 12-item scale assessed on a 4-point Likert response scale with options ranging from definitely false to definitely true and summed to produce a total score and sub-scale scores. The minimum value for this scale is 12 and the maximum value is 48. Higher scores indicate a better income."|Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)|"The Overall Number of Participants Analyzed reflects the number of participants at Time 1"|||score on a scale||Standard Deviation|Mean
2693105|NCT01297985|Primary|Personal Empowerment|Personal psychological empowerment is measured via the Boston University Empowerment Scale (Rogers et al.,1997). This 28-item instrument designed to measure subjective feelings of empowerment via self-report in which respondents answer questions on a four-point scale ranging from Strongly Agree to Strongly Disagree. The minimum score is 28 and the maximum is 112, with higher scores indicating a better outcome.|Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)|"The Overall Number of Participants Analyzed reflects the number of participants at Time 1"|||score on a scale||Standard Deviation|Mean
2693106|NCT01297985|Primary|Recovery From Mental Illness|"Recovery from mental illness is measured by the Recovery Assessment Scale (RAS) (Giffort et al., 1995). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-response format ranging from strongly disagree to strongly agree. The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no being dominated by one's residual psychiatric symptoms."|Study entry (Pre-intervention/T1), 8-weeks later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)|"The Overall Number of Participants Analyzed reflects the number of participants at Time 1"|||score on a scale||Standard Deviation|Mean
2693107|NCT01297920|Primary|Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3|The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.|||millimeters mercury (mm HG)||Standard Error|Least Squares Mean
2693108|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0- ∞) [MRAUC (0- ∞)].|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.|||Ratio||Standard Deviation|Geometric Mean
2693109|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2693110|NCT01297595|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite (PF-06260182) to parent (crizotinib) molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2693111|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2693112|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2693113|NCT01297595|Secondary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2693114|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2693217|NCT01296698|Secondary|Highest Rating of Increased Appetite on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Increased Appetite on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693115|NCT01297595|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Liter||Standard Deviation|Geometric Mean
2693116|NCT01297595|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the plasma. Clearance obtained after oral dose (apparent oral clearance [CL/F]) is influenced by the fraction of the dose absorbed (F).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Liter/hour (L/hr)||Standard Deviation|Geometric Mean
2693117|NCT01297595|Secondary|Plasma Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2693118|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2693119|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2693120|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2693121|NCT01297595|Primary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2693122|NCT01297517|Primary|Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)|At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-treat (ITT): All patients who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.|||millimeters mercury (mm Hg)||Standard Error|Least Squares Mean
2693123|NCT01297504|Secondary|Mean Number of Doses of Palivizumab Administered||12 months||||doses||Standard Deviation|Mean
2693124|NCT01297504|Primary|Distribution of Comorbidities in Study Participants|The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.|Baseline||||percentage of participants|||Number
2693125|NCT01297504|Secondary|Compliance to Prescribed Palivizumab|Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.|12 months||||Percentage of expected dose||95% Confidence Interval|Number
2693126|NCT01297504|Secondary|Risk Factors for Hospitalization|Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.|Baseline and 12 months||||rate ratio||95% Confidence Interval|Number
2693127|NCT01297504|Secondary|Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV||12 months|Participants with hospitalization due to LTRI and hospitalization due to LTRI and RSV.|||hospitalization episodes|Participants||Number
2693128|NCT01297504|Secondary|Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV|The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.|12 months||||participants|||Number
2693129|NCT01297504|Primary|Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection|Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).|Baseline||||participants|||Number
2693130|NCT01297491|Secondary|Duration of Response (DoR)|DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.|||Days|||Number
2693131|NCT01297491|Secondary|Time to Response (TTR)|TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.|||Days|||Number
2693132|NCT01297491|Secondary|Disease Control Rate (DCR)|"DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.~Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline."|Every 6 weeks up tp 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Percentage of participants|||Number
2693133|NCT01297491|Secondary|Overall Response Rate (ORR) Based on Investigator Assessment|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Percentage of participants|||Number
2693134|NCT01297491|Secondary|Overall Survival (OS) Using Kaplan-Meier Estimates|OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.|Every 8 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2693135|NCT01297491|Primary|Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12|"PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a success for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed.~No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group."|Week 12|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2693136|NCT01297465|Secondary|Heart Rate Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||beats per minute (bpm)||Standard Deviation|Mean
2693137|NCT01297465|Secondary|Systolic and Diastolic Arterial Blood Pressure Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||millimeter of mercury ( mm Hg)||Standard Deviation|Mean
2693138|NCT01297465|Secondary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||participants|||Number
2693139|NCT01297465|Secondary|Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||participants|||Number
2693218|NCT01296698|Secondary|Highest Rating of Insomnia on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Insomnia on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693141|NCT01297465|Secondary|Biochemical Pregnancies Rate|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. . N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."|||participants|||Number
2693142|NCT01297465|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment|An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment.|S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||participants|||Number
2693143|NCT01297465|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer [ET]).|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and had completed the primary efficacy assessment. N signifies those participants who had their ET in study treatment cycle. n signifies those participants who were evaluated for this measure in specified categories."|||percentage of participants|||Number
2693144|NCT01297465|Secondary|Number of Fetal Hearts With Activity|Number of fetal hearts with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||fetal hearts||Standard Deviation|Mean
2693145|NCT01297465|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||fetal sacs||Standard Deviation|Mean
2693146|NCT01297465|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.|||percent sacs per embryo||Standard Deviation|Mean
2693147|NCT01297465|Secondary|Total Number of Stimulation Treatment Days||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||days||Standard Deviation|Mean
2693148|NCT01297465|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||IU||Standard Deviation|Mean
2693149|NCT01297465|Primary|Total Number of Oocytes Retrieved|The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])|Modified intention-to-treat (Mod-ITT) population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.|||oocytes||Standard Deviation|Mean
2693150|NCT01297348|Primary|Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls|Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.|||participants|||Number
2693151|NCT01297348|Primary|Incidence Rate of Idiopathic Venous Thromboembolism (VTE)|Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.|||incidence rate per 100000 person-years|||Number
2693164|NCT01297309|Secondary|Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months)|Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Nanogram per liter (ng/L)||Standard Deviation|Mean
2693152|NCT01297335|Secondary|Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection|Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.|Before clonidine injection (Baseline), and at 1 hour after clonidine injection.|All qualified subjects were given intrathecal clonidine and were asked to rate level of sedation and sensation of dry mouth before clonidine injection (baseline) and 1 hour post injection on VAS scale.|||cm||Standard Deviation|Mean
2693153|NCT01297335|Secondary|Likert Scale Pain Rating|Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.|Pre-dose and 1 hour post injection.|All subjects met inclusion and exclusionary criteria, and received intrathecal injection of clonidine. Subjects were asked to rate their baseline pain on Likert scale prior to receiving intrathecal clonidine injection, and 1 hour post intrathecal clonidine injection.|||units on a scale||Standard Deviation|Mean
2693154|NCT01297335|Primary|Change in Blood Pressure After Intrathecal Injection of Clonidine.|"Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.~Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline."|Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection|All subjects met inclusion and exclusionary criteria, and was given an intrathecal injection of clonidine. They were followed for changes in blood pressure for 4 hours.|||mm Hg||Standard Deviation|Mean
2693155|NCT01297322|Secondary|Rate of Combined Minor Access Site Complications|"Secondary safety endpoint~Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis;~Access site-related hematoma > 6 cm;~Late access site-related bleeding (following hospital discharge);~Ipsilateral lower extremity arterial emboli;~Ipsilateral deep vein thrombosis;~Access site-related vessel laceration;~Access site wound dehiscence;~Localized access site infection treated with intramuscular or oral antibiotics;~Arteriovenous fistula not requiring treatment;~Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection;~Pseudoaneurysm not requiring treatment;~New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair;~Ipsilateral pedal pulse diminished by two grades or transiently lost."|30 days +/- 7 days||||participants|||Number
2693156|NCT01297322|Secondary|Procedure Success|Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days|30 days +/- 7 days||||participants|||Number
2693157|NCT01297322|Secondary|Device Success|Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression|Up to 1 day||||participants|||Number
2693158|NCT01297322|Secondary|Time to Hospital Discharge (TTHD)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital|Up to 2 days||||hours||Standard Deviation|Mean
2693159|NCT01297322|Secondary|Time to Discharge Eligibility (TTDE)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team|Up to 2 days||||hours||Standard Deviation|Mean
2693160|NCT01297322|Secondary|Time to Ambulation (TTA)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding|Up to 1 day||||hours||Standard Deviation|Mean
2693161|NCT01297322|Primary|Rate of Combined Access Site-related Major Complications|"Primary safety endpoint~Access site-related bleeding requiring transfusion;~Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft);~New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.;~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization;~New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair;~Permanent access site-related nerve injury. (> 30 days)"|30 days +/- 7 days||||participants|||Number
2693162|NCT01297322|Primary|Time to Hemostasis (TTH)|Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.|Up to 1 hour||||minutes||Standard Deviation|Mean
2693163|NCT01297309|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months)|Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry [DXA] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, Week 52 and EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||gram per square centimeter (g/cm^2)||Standard Deviation|Mean
2693219|NCT01296698|Secondary|Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Dysphoric or Depressed Mood on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693165|NCT01297309|Secondary|Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months)|Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Microgram per liter (μg/L)||Standard Deviation|Mean
2693166|NCT01297309|Secondary|Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months)|The normal range of calcium phosphate product is defined as <= 4.441 millimoles square per liter square (mmol^2/L^2).|EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.|||Count of participants|||Number
2693167|NCT01297309|Secondary|Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months)|Change of serum phosphate from baseline were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, Month 72, EOT (upto 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Millimoles per day (mmol/day)||Standard Deviation|Mean
2693168|NCT01297309|Secondary|Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months)|Change in serum calcium concentration of the number of participants who used at least one calcium-sparing diuretics and not used calcium sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, EOT (upto 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2693169|NCT01297309|Secondary|Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months)|Change from baseline in urinary calcium concentration in participants who used at least one calcium-sparing diuretics and participants who not used calcium-sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Millimoles per day (mmol/day)||Standard Deviation|Mean
2693170|NCT01297309|Secondary|Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months)|Change in 24 hour urine calcium excretion was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.|||Millimoles per day (mmol/day)||Standard Deviation|Mean
2693171|NCT01297309|Secondary|Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months)|Percent change in ACSC was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.|||Percent change in ACSC||Standard Deviation|Mean
2693172|NCT01297309|Secondary|Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months)|Percent change from baseline of oral calcitriol supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, Week 52 and EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.|||%changeoforal calcitriol supplementation||Standard Deviation|Mean
2693173|NCT01297309|Secondary|Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months)|Percent change from baseline of oral calcium supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.|Baseline, Week 52 and EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.|||% change of oral calcium supplementation||Standard Deviation|Mean
2693174|NCT01297309|Primary|Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months)|A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (>) 50% reduction from baseline or less than (<) 500 milligram (mg) of daily calcium supplementation. (2) a >50% reduction from baseline or <0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at EOT was reported here.|EOT (up to 82 months)|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2693184|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693220|NCT01296698|Secondary|Highest Rating of Anxiety on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Anxiety on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693175|NCT01297309|Primary|Number of Responders With Calcium Source at Week 52|A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (>) 50% reduction from baseline or less than (<) 500 milligram (mg) of daily calcium supplementation. (2) a >50% reduction from baseline or <0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at week 52 was reported here.|Week 52|ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2693176|NCT01297309|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)|SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical or medicinal product. Treatment emergent adverse events (TEAEs) were defined as AEs whose onset occurs, severity worsens or intensity increases after receiving the study medication of this study and <= 30 days after last dose of study drug.|From start of study drug administration up to follow-up (82 months)|Safety population included all enrolled participants who received at least 1 dose of study drug and had post baseline safety data.|||Participants|||Count of Participants
2693177|NCT01297283|Secondary|Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.|"The following factors will be evaluated to investigate whether they influence the LECG quality:~device position (subcutaneous, submuscular, etc)~device rotation~device fixation~device side facing the skin~position of lead loops in the pocket~use of antibiotics in the pocket~skin type (loose, normal, firm)~body mass index (BMI)~The endpoints will be:~describe R wave amplitude values~describe proportion of patients with P wave visible on intrinsic LECG strips recorded at 1-Month FU."|30 to 120 days|||||||
2693178|NCT01297283|Secondary|Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.|"The intrinsic R wave amplitude and P waves visibility will be taken to evaluate the effect of posture changes and artifact-inducing maneuvers on the quality of LECG at the 1-Month Follow-Up visit (LECG vector with best combination of the highest R wave and most visible P wave).~The endpoints will be R wave amplitude and P wave visibility in different positions (meaning visible or not visible in both positions).~R wave changes and proportion of patients with stable P waves visibility at lying position versus other positions will be calculated by an independent reviewer."|30 to 120 days|||||||
2693179|NCT01297283|Secondary|Quality of LECG in New Devices Versus Device Replacements.|"The two following parameters will be used to compare the quality of LECG in new implants versus device replacements at PHD and 1-Month on the same LECG vector:~Intrinsic R wave amplitude~P waves visibility The LECG vector at PHD with best combination of the highest R wave and most visible P wave will be selected.~R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.~The endpoints will be:~comparison of mean R wave values at PHD and 1-month~comparison of proportion of patients with P wave visible at PHD and 1-month."|30 to 120 days|||||||
2693180|NCT01297283|Secondary|Evaluation of the Stability of LECG Performance Over Time.|"Two parameters will be used to evaluate LECG changes between PHD and 1-Month on the same LECG vector: intrinsic R wave amplitude and P waves visibility (selection the LECG vector at PHD with best combination of the highest R wave and most visible P wave).~R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.~The endpoints evaluated are:~mean R wave changes from PHD to 1-month~proportion of patients with stable P wave visibility at PHD and 1-Month (meaning both visits visible or both visits not visible)."|30 to 120 days|||||||
2693181|NCT01297283|Secondary|Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.|"The investigator will simulate loss of capture (LOC) at 1-Month Follow-Up visit by printing strips of LOC in both ventricular leads, LOC in LV lead only, LOC in RV lead only, no LOC. One strip randomly selected among them by the study manager will be submitted to an independent reviewer. With help of the PHD template LECG strips (intrinsic, RV paced, LV paced, BiV paced) of this patient, he/she will determine which lead is capturing.~The endpoint is the proportion of correct classifications of ventricular capture done by then independent reviewer of LECG."|30 to 120 days|Proportion of Patients Correctly Classified|||proportion||95% Confidence Interval|Number
2693182|NCT01297283|Primary|Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.|During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.|30 to 120 days||||proportion||95% Confidence Interval|Number
2693183|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693201|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
2693185|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693186|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693187|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693188|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693189|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693190|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2693191|NCT01297270|Secondary|Early Treatment Success (ETS)|Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|Week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants|||Number
2693192|NCT01297270|Secondary|Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|"Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.~Hepatitis C virus Ribonucleic acid (HCV RNA)"|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.|||percentage of participants||95% Confidence Interval|Number
2693193|NCT01297270|Primary|Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2693194|NCT01297257|Secondary|In-hospital MACE (Major Adverse Cardiac Event)||stent implantation until hospital discharge (average 1-3 days)||||Participants|||Number
2693195|NCT01297257|Primary|Delivery Success|The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.|stent implantation until hospital discharge (average 1-3 days)||||stents|Participants||Number
2693196|NCT01297062|Secondary|Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3|The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed.|Baseline, Day 1, 2, and 3|Evaluable Population. No imputation for missing value was used. Day 1, 2, and 3 exenatide concentration < LLOQ was set to missing.|||pg/mL||Standard Error|Geometric Mean
2693197|NCT01297062|Secondary|Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with increase of QTcP interval from baseline >30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Baseline, Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.|||particpants|||Number
2693198|NCT01297062|Secondary|Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.|||participants|||Number
2693199|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
2693200|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
2693202|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 3|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
2693203|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
2693204|NCT01297062|Primary|Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.|Baseline, Day 1|Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.|||msec||90% Confidence Interval|Least Squares Mean
2693205|NCT01296841|Secondary|Clinic Appointment Wait Time|The investigators recorded clinic appointment wait time duration in minutes|Clinic Visit||||minutes||Standard Deviation|Mean
2693206|NCT01296841|Secondary|Clinic Appointment Duration|The investigators recorded appointment duration in minutes.|Clinic Visit|Pilot.|||Minutes||Standard Deviation|Mean
2693207|NCT01296841|Primary|Patient Clinical Experience|We used a validated Ware Specific Visit Questionnaire to assess patients' satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor-patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.|Clinic Visit|per protocol|||units on a scale||Standard Deviation|Mean
2693208|NCT01296815|Secondary|Safety|Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.|12 months|||||||
2693209|NCT01296815|Primary|Number of Participants With Complete Response|Complete response will be assessed according to RECIST criteria|12 months||||participants|||Number
2693210|NCT01296763|Secondary|Number of Years From Cycle 1, Day 1 On-Study to Date of Death|The overall survival of subjects with locally advanced and/or metastatic pancreatic cancer treated with Irinotecan, Cisplatin, Olaparib, with escalation to the addition of Mitomycin-C. Survival from cycle 1, day 1 on-study to date of death was assessed.|5 years||||years (survival) from C1D1 to death||Full Range|Mean
2693211|NCT01296763|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)|"1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1:~Thrombocytopenia with platelets <25,000 x106/l > 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation.~Delay of >2 weeks for next scheduled IC/ICM for reasons of toxicity."|2 years|Number of subjects who experienced a dose limiting toxicity, as defined in the protocol.|||participants|||Number
2693212|NCT01296698|Secondary|Participant Score for Product Convenience|Participants are asked to rate how convenient the product is to use, on a scale of 1-5, where 1=not at all convenient and 5=extremely convenient.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
2693213|NCT01296698|Secondary|Participant Score for Change in Perception|Participants are asked to rate how their opinion has changed since the first time they used it, on a score of 1-5, where 1=I like it much less now and 5=I like it much more now.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
2693214|NCT01296698|Secondary|Participant Score for Speed of Action|Participants are asked to rate the product for speed of action, on a scale of 1-9, where 1=extremely slow and 9=extremely fast.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
2693215|NCT01296698|Secondary|Participant Score for Product Effectiveness in Dealing With Cravings|Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
2693216|NCT01296698|Secondary|Participant Score for General Perception of the Product|Participants are asked to rate their general perception of the investigational product on a scale of 1-10, where 1=very poor and 10=excellent.|through Week 12|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
2693725|NCT01292304|Secondary|Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)|Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing|12 weeks||||participants|||Number
2693221|NCT01296698|Secondary|Highest Rating of Difficulty Concentrating on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Difficulty Concentrating on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and completed the questionnaire.|||Percentage of Participants|||Number
2693222|NCT01296698|Secondary|Highest Rating of Restlessness on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Restlessness on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693223|NCT01296698|Secondary|Highest Rating of Irritability/Frustration/Anger on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Irritability/Frustration/Anger on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693224|NCT01296698|Secondary|Highest Rating of Desire/Urge to Smoke on a Categorical Scale|Participants are asked if during the last 24 hours they experienced the Desire/Urge to Smoke on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
2693225|NCT01296698|Secondary|Percentage of Participants With High Usage|Percentage of participants who used more than four doses in any one-hour period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.|||Percentage of Participants|||Number
2693226|NCT01296698|Secondary|Percentage of Participants With High Dosage|Percentage of participants who used more than 64 doses in any one-day period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.|||Percentage of Participants|||Number
2693227|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 6|Analysis was limited to data collected from participants at Week 6. Analysis of data for the remainder of the study weeks was not possible because the trial terminated prematurely due to a technical issue (randomization error).|||Daily Doses||Standard Deviation|Mean
2693228|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 5|Analysis was limited to data collected from participants at Week 5.|||Daily Doses||Standard Deviation|Mean
2693229|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 4|Analysis was limited to data collected from participants at Week 4.|||Daily Doses||Standard Deviation|Mean
2693230|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 3|Analysis was limited to data collected from participants at Week 3.|||Daily Doses||Standard Deviation|Mean
2693231|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 2|Analysis was limited to data collected from participants at Week 2.|||Daily Doses||Standard Deviation|Mean
2693232|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 1|Analysis was limited to data collected from participants at Week 1.|||Daily Doses||Standard Deviation|Mean
2693233|NCT01296698|Secondary|Number of Participants With 7-day Point Prevalence Abstinence|Number of participants with carbon monoxide (CO)-verified self-reported 7-day point prevalence abstinence from smoking at Weeks 2, 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error).|||Participants|||Number
2693234|NCT01296698|Secondary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self report of continuous abstinence from smoking from Week 2 to Weeks 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Participants|||Number
2693235|NCT01296698|Primary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.|through Week 6|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Participants|||Number
2693236|NCT01296672|Secondary|T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer|Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days|Receiving biopsy|||Ratio||95% Confidence Interval|Number
2693237|NCT01296672|Secondary|PCA3 (Prostate Cancer Antigen 3)Score AUC|Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)|Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day|Receiving biopsy|||ratio||95% Confidence Interval|Number
2693238|NCT01296672|Primary|Pre/Post Ratio PSA Area Under the Curve (AUC)|Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.|Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months|Patients with biopsy|||Ratio||95% Confidence Interval|Number
2693239|NCT01296646|Secondary|Percent Days Abstinent|Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.|12 weeks||||percentage of days||Standard Deviation|Mean
2693240|NCT01296646|Primary|Percent Heavy Drinking Days|Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.|12 weeks||||percentage of days||Standard Deviation|Mean
2693259|NCT01296360|Secondary|Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and||36 months|||||||
2693788|NCT01292005|Primary|Change in Interleukin (IL) IL-6|Normal value range for IL-6 = 0 - 5 pg/ml.|baseline, Day 1, Day 3||||pg/ml||Full Range|Median
2693241|NCT01296568|Secondary|The Number of Participants With a Tumor Response|Tumor responses were followed and measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete response was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. Partial response was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable disease was defined as small changes that did not meet above criteria.|Baseline through study completion [Cycle 5 (28 days/cycle) and 21-day safety follow-up]|All enrolled participants who had radiological tumor assessment.|||Participants|||Count of Participants
2693242|NCT01296568|Secondary|Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Feces|Relative abundance was expressed as the percentage of the dose of study drug administered and calculated as %=[amount of LY2603618 or its metabolites excreted/amount of radioactive dose administered]*100.|Day 1 through 7 days postdose|All enrolled participants.|||percentage of [^14C]LY2603618||Full Range|Mean
2693243|NCT01296568|Secondary|Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Urine|Relative abundance was expressed as the percentage of the dose of study drug administered and calculated as %=[amount of LY2603618 or its metabolites excreted/amount of radioactive dose administered]*100.|Day 1 through 7 days postdose|All enrolled participants.|||percentage of [^14C]LY2603618||Full Range|Mean
2693244|NCT01296568|Secondary|Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)]|Plasma radioactivity AUC(0-tlast) [nanogram equivalents*hours per milliliter (ng Eq*h/mL)] where tlast is the last time point with a measurable concentration following a single dose on Day 1.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|All enrolled participants.|||ng Eq*h/mL||Geometric Coefficient of Variation|Geometric Mean
2693245|NCT01296568|Secondary|Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)]|Plasma LY2603618 AUC(0-tlast) where tlast is the last time point with a measurable concentration following a single dose on Day 1.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|All enrolled participants.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2693246|NCT01296568|Secondary|Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)]|Plasma radioactivity AUC(0-infinity) [nanogram equivalents*hours per milliliter (ng Eq*h/mL)] following a single dose on Day 1.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|All enrolled participants.|||ng Eq*h/mL||Geometric Coefficient of Variation|Geometric Mean
2693247|NCT01296568|Secondary|Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)]|Plasma LY2603618 AUC(0-infinity) following a single dose on Day 1.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|All enrolled participants.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2693248|NCT01296568|Secondary|Plasma Pharmacokinetics of Radioactivity: Maximum Observed Drug Concentration (Cmax)|Plasma radioactivity Cmax [nanogram equivalents per milliliter (ng Eq/mL)] following a single dose on Day 1.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|All enrolled participants.|||ng Eq/mL||Geometric Coefficient of Variation|Geometric Mean
2693249|NCT01296568|Secondary|Plasma Pharmacokinetics of LY2603618: Maximum Observed Drug Concentration (Cmax)|Plasma LY2603618 Cmax following a single dose on Day 1.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|All enrolled participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2693250|NCT01296568|Primary|Urinary and Fecal Excretion of LY2603618 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered|Urinary and fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine and fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.|0 to 6 hours, 6 to 12, 12 to 24, 24 to 48, 48 to 72 and 72 to 96 hours post-dose|All enrolled participants.|||percentage of total dose||Standard Deviation|Mean
2693251|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <6.5%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||percentage of participants|||Number
2693252|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <7.0%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||percentage of participants|||Number
2693253|NCT01296412|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline at Week 26 is defined as Week 26 minus Week 0.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
2693254|NCT01296412|Primary|Change From Baseline in Hemoglobin A1c (A1C)|A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||percent||95% Confidence Interval|Least Squares Mean
2693255|NCT01296360|Secondary|Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration.||7 days|||||||
2693256|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month|||||||
2693257|NCT01296360|Secondary|Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month|||||||
2693258|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.||36 months|||||||
2693268|NCT01296347|Secondary|Sensory Testing|"Hypoaesthesia: light touch of the blunt end of a paintbrush was felt less precisely, than in healthy tissue.~Hyperalgesia: the pain induced by a sterile neurotip, applied perpendicular to the skin is felt abnormally strongly, in comparison to the contralateral side.~Static allodynia: the application of a Von Frey hair number 14. (8g) was unpleasant, in comparison to the contralateral side.~Dynamic allodynia: three successive gentle strokes of an 8 mm-wide paintbrush over a 40 mm distance, is unpleasant, in comparison to the contralateral side."|6 weeks, 6 months, 12 months|||||||
2693269|NCT01296347|Secondary|Analgesic Consumption (Opioid)|Analgesia consumption will be measured post-operatively and at 6 weeks|6 weeks, 3 month, 6 month|Participant who experienced pain.|||mg||Inter-Quartile Range|Median
2693270|NCT01296347|Primary|Pain Score on Moving at 6 Weeks|"Measures in pain include:~Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'"|6 weeks after surgery|Ketamine group one participant did not have data|||units on a scale||Inter-Quartile Range|Median
2693271|NCT01296191|Primary|Pharmacokinetics in Aqueous Humor Samples.|Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.|Measured after 3 days of drug instillation||||ng/ml||Standard Deviation|Mean
2693272|NCT01296152|Secondary|Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.|This evaluates the effect of MPA on Tregs at baseline (Day 0), week 4 and week 12 using flow cytometry in freshly thawed PBMCs. A summary of CD4+ and cluster of differentiation 8 (CD8+) anchored T-cell subsets by study week, in percent that express the marker of interest, is presented here together to provide all results pertaining to this objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 21 participants with available data were analyzed.|||Percent CD4/CD8 cells expressing marker||Inter-Quartile Range|Median
2693273|NCT01296152|Secondary|CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).|This evaluates the effect of MPA on CMI to HIV and VZV. This outcome was measured at Baseline Before DMPA (Day 0) and After DMPA (Weeks 4 and 12) using the Lymphocyte Proliferation Assay (LPA). The data table shows a summary of LPA assay results by study week with stimuli HIV and VZV. Proliferation results are reported as a stimulation index (SI) which represents the ratio of the stimulated counts per minute to unstimulated control counts per minute.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.|||SI Ratio||Inter-Quartile Range|Median
2693274|NCT01296152|Secondary|Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.|This evaluates the effect of MPA on CMI to HIV and VZV at baseline before DMPA (day 0) and after DMPA (weeks 4 and 12) . Cytokines are interferon-gamma (IFN-gamma) and interleukin 2 (IL-2), and Stimuli are HIV and VZV. Summary of adjusted ELISPOT assay results is in spot forming cells (SFC)/10^6 peripheral blood mononuclear cells (PBMC) by study weeks 0, 4 and 12. The outcome measures of IFN-gamma and IL-2 measured for HIV and VZV are presented here together to provide all results pertaining to the same objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.|||SFC/10^6 PBMC||Inter-Quartile Range|Median
2693275|NCT01296152|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.|This evaluates the short-term impact of MPA on virologic suppression in participants taking LPV/r who have received a dose of DMPA by measuring percentage of participants with HIV-1 RNA levels <400 copies/mL at day 0 (prior to DMPA injection) and at weeks 2, 4, 8 and 12 (after DMPA injection). An FDA-approved HIV-1 RNA assay with a lower limit of detection of 75 copies/mL or less was required and the same HIV-1 RNA assay was required to be performed for each participant across all study visits. The Roche COBAS AmpliPrep/TaqMan HIV-1 and Abbott RealTime HIV-1 tests were used.|Day 0, Weeks 2, 4, 8, and 12|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the HIV-1 RNA draw (see N for each week in table below).|||Percent of Participants|||Number
2693276|NCT01296152|Secondary|Percentage of Participants With Menstrual Irregularities of Grade 1 and Higher Deemed Possibly, Probably or Definitely Related to Study Treatment.|This evaluates toxicity and safety of concomitant medication of DMPA and LPV/r, focusing specifically on the adverse event (AE) menstrual irregularities with abnormal vaginal bleeding. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study's co-chairs.|From day 0 to week 12|This analysis focuses on the 24 participants eligible for the PK analyses.|||Percent of Participants|||Number
2693277|NCT01296152|Secondary|RTV PK Parameter T1/2.|This evaluates the effect of MPA on the PK parameter T1/2 of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC. For one participant at day 0, T1/2 results were not estimated.|||hour||Full Range|Median
2693278|NCT01296152|Secondary|RTV PK Parameter CL/F.|This evaluates the effect of MPA on the PK parameter CL/F of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||L/hour||Full Range|Median
2693279|NCT01296152|Secondary|RTV PK Parameter Tmax.|This evaluates the effect of MPA on the PK parameter Tmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||hour||Full Range|Median
2693280|NCT01296152|Secondary|RTV PK Parameter Cmax.|This evaluates the effect of MPA on the PK parameter Cmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
2693281|NCT01296152|Secondary|RTV PK Parameter Cmin.|This evaluates the effect of MPA on the PK parameter Cmin of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
2693282|NCT01296152|Secondary|Ritonavir (RTV) PK Parameter AUC0-12h.|This evaluates the effect of MPA on the PK parameter AUC0-12h of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. Blood samples were drawn for RTV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||ng*h/mL||Full Range|Median
2693283|NCT01296152|Secondary|LPV PK Parameter T1/2.|This evaluates the effect of MPA on the secondary LPV PK parameter T1/2 obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||hour||Full Range|Median
2693284|NCT01296152|Secondary|LPV PK Parameter CL/F.|This evaluates the effect of MPA on the secondary LPV PK parameter CL/F obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||L/hour||Full Range|Median
2693285|NCT01296152|Secondary|LPV PK Parameter Tmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Tmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||hour||Full Range|Median
2693286|NCT01296152|Secondary|LPV PK Parameter Cmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
2693287|NCT01296152|Secondary|LPV PK Parameter Cmin.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmin obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
2693288|NCT01296152|Secondary|MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter T1/2 based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC. A minimum of three observations in the elimination phase was required to determine T1/2 and therefore results are presented for 22 participants.|||week||Full Range|Median
2693289|NCT01296152|Secondary|MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter CL/F based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||L/week||Full Range|Median
2693290|NCT01296152|Secondary|MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Tmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||week||Full Range|Median
2693291|NCT01296152|Secondary|MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||ng/mL||Full Range|Median
2693292|NCT01296152|Secondary|MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmin based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||ng/mL||Full Range|Median
2693293|NCT01296152|Secondary|Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).|This evaluates the suppression of ovulation due to the potential PK interaction between DMPA and LPV/r. The LLQ of progesterone is 0.5ng/mL. The threshold for suppression of ovulation is 5ng/mL.|0, 2, 4, 6, 8, 10, and 12 weeks|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the progesterone draw (see N for each week in table below).|||Percent of Participants|||Number
2693294|NCT01296152|Primary|AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)|This evaluates the effect of DMPA on LPV PK parameter AUC by comparing PK AUCs of LPV from 0 to 12 hours obtained at study Day 0 (before DMPA was administered) with PK AUCs of LPV from 0 to 12 hours at study Week 4 (4 weeks after DMPA was administered). Blood samples were drawn for LPV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|All participants eligible for the first primary PK outcome measure (MPA AUC0-12weeks) were included in this second primary outcome measure looking at LPV AUC0-12hours at Day 0 and week 4.|||ng*h/mL||Full Range|Median
2693376|NCT01295710|Secondary|Number of Participants With Chronic GVHD Severe|Participants with the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks|Time from first study drug administration until the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693295|NCT01296152|Primary|Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)|This evaluates the effect of lopinavir/ritonavir (LPV/r) on pharmacokinetic parameter AUC of MPA by looking at the MPA AUC from day 0 to week 12. AUC0-12weeks was calculated using single MPA concentrations sampled immediately prior to DMPA administration on day 0, and at 2, 4, 6, 8, 10 and 12 weeks after administration of the single DMPA dose.|Day 0, Weeks 2, 4, 6, 8, 10 and 12|One participant was excluded from all PK analyses for taking a prohibited medication with potential to interfere with PK assessments. For another participant who missed week 10 and 12 visits, a modelling approach was used to estimate the week 12 MPA level.|||ng*wk/mL||Full Range|Median
2693296|NCT01296035|Secondary|Adverse Events, Measured by Active Version of the NCI Common Toxicity Criteria|Adverse events (AEs) will be recorded during the duration of the trial, whether or not the events are considered related to medication. All AEs considered to be related to trial therapy will be followed for resolution, including into the post-treatment period.|Every 4 weeks while on-study, up to 24 weeks|Please see results section. In short, there were 3 serious adverse events (1 thromboembolic, 1 hypomagnesemia, 1 bowel obstruction). Additional adverse events included (in decreasing order) rash, fatigue, anemia, edema, thrombocytopenia, abdominal pain, epistaxis, hypocalcemia, and calciphylaxis|||participants|Participants||Number
2693297|NCT01296035|Primary|Overall Response Rate, Measured by RECIST Criteria|Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.|Every 8 weeks while on-study|Due to the small number of participants, data were not collected as planned||||||
2693298|NCT01295905|Secondary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.|||Units on a scale||Standard Deviation|Mean
2693299|NCT01295905|Secondary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.|||Units on a scale||Standard Deviation|Mean
2693300|NCT01295905|Secondary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.|||Units on a scale||Standard Deviation|Mean
2693301|NCT01295905|Primary|Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity|Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.|3 months of wear, lenses replaced daily|Per protocol.|||eyes|Participants||Number
2693302|NCT01295879|Secondary|Recurrence of Kidney Stones||8 weeks||||# of stone recurrences|||Number
2693303|NCT01295879|Secondary|Change in 24 Hour Urine Supersaturation of Calcium Oxalate|Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones|8 weeks||||(unitless)||Standard Deviation|Mean
2693304|NCT01295879|Primary|Change in 24 Hour Urine Calcium|Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones|8 weeks||||mg/day||Standard Deviation|Mean
2693305|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At 6 months||||participants|||Number
2693306|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At 6 months||||participants|||Number
2693307|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At enrollment||||participants|||Number
2693308|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At enrollment||||participants|||Number
2693309|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|At 6 months||||number of vectors|Number of vectors||Number
2693310|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)||||number of vectors|Number of total vectors||Number
2693311|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|6 months post-implant||||volts||Standard Deviation|Mean
2693312|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)||||volts||Standard Deviation|Mean
2693313|NCT01295840|Secondary|Cardiac Output (CO) With Different Configurations at Enrollment|Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.|Enrollment visit (in the seven days after implantation of the device)||||L/min||Standard Deviation|Mean
2693314|NCT01295840|Secondary|Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors|"In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.~The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC."|At enrollment||||percentage of difference of CO||Standard Deviation|Mean
2693315|NCT01295840|Primary|Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.||Enrollment visit (in the seven days after implantation of the device)||||participants|||Number
2693316|NCT01295827|Secondary|PFS According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)|PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. According to irRC, PD was defined as at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented. PFS according to irRC as assessed by the investigator was reported for each NSCLC dose arm (Parts C plus F).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Months||95% Confidence Interval|Median
2693317|NCT01295827|Secondary|DOR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)|For participants who demonstrated a confirmed irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or irPR (decrease in SPD of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC, DOR was defined as the time from first documented evidence of an irCR or irPR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. According to irRC, PD was defined as at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented. The DOR according to irRC as assessed by the investigator for all participants who experienced a confirmed irCR or irPR was reported for each NSCLC dose arm (Parts C plus F).|From time of first documented evidence of iCR or iPR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment and who demonstrated a confirmed response (CR or PR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B and D) participants were analyzed and presented separately and are not included in this analysis.|||Months||Full Range|Median
2693318|NCT01295827|Secondary|DCR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)|DCR according to irRC was defined as the percentage of participants who had a irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions), irPR (decrease in SPD of ≥50% by a consecutive assessment ≥4 weeks after first documentation), or SD (neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for PD [at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented]). The percentage of participants who experienced a confirmed CR, PR, or SD according to irRC as assessed by the investigator was reported as the DCR for each NSCLC dose arm (Parts C plus F).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693319|NCT01295827|Secondary|OS in NSCLC Participants (Parts C Plus F)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. OS was reported for each NSCLC dose arm (Parts C plus F).|Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Months||95% Confidence Interval|Median
2693320|NCT01295827|Secondary|PFS According to RECIST 1.1 as Assessed by IRC in NSCLC Participants (Parts C Plus F)|PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS according to RECIST 1.1 as assessed by IRC was reported for each NSCLC dose arm (Parts C plus F).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Months||95% Confidence Interval|Median
2693327|NCT01295827|Secondary|Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B Plus D)|PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS according to RECIST 1.1 as assessed by IRO was reported for each melanoma dose arm (Parts B plus D).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Months||Full Range|Median
2693321|NCT01295827|Secondary|DOR According to RECIST 1.1 as Assessed by IRC in NSCLC Participants (Parts C Plus F)|For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on IRC with confirmation. The DOR according to RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported for each NSCLC dose arm (Parts C plus F).|From time of first documented evidence of CR or PR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment and who demonstrated a confirmed response (CR or PR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B and D) participants were analyzed and presented separately and are not included in this analysis.|||Months||Full Range|Median
2693322|NCT01295827|Secondary|DCR According to RECIST 1.1 as Assessed by IRC in NSCLC Participants (Parts C Plus F)|DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by IRC was reported as the DCR for each NSCLC dose arm (Parts C plus F).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693323|NCT01295827|Secondary|PFS According to irRC as Assessed by Investigator in Melanoma Participants (Parts B Plus D)|PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. According to irRC, PD was defined as at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented. PFS according to irRC as assessed by the investigator was reported for each melanoma dose arm (Parts B plus D).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Months||95% Confidence Interval|Median
2693324|NCT01295827|Secondary|DOR According to irRC as Assessed by Investigator in Melanoma Participants (Parts B Plus D)|For participants who demonstrated a confirmed irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or irPR (decrease in SPD of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC, DOR was defined as the time from first documented evidence of an irCR or irPR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. According to irRC, PD was defined as at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented. The DOR according to irRC as assessed by the investigator for all participants who experienced a confirmed irCR or irPR was reported for each melanoma dose arm (Parts B plus D).|From time of first documented evidence of iCR or iPR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment and who demonstrated a confirmed irRC response (irCR or irPR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Months||Full Range|Median
2693325|NCT01295827|Secondary|DCR According to irRC as Assessed by Investigator in Melanoma Participants (Parts B Plus D)|DCR according to irRC was defined as the percentage of participants who had a irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions), irPR (decrease in SPD of ≥50% by a consecutive assessment ≥4 weeks after first documentation), or SD (neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for PD [at least a 25% increase in SPD relative to nadir (minimum recorded tumor burden) with confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented]). The percentage of participants who experienced a confirmed CR, PR, or SD according to irRC as assessed by the investigator was reported as the DCR for each melanoma dose arm (Parts B plus D).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693326|NCT01295827|Secondary|Overall Survival (OS) in Melanoma Participants (Parts B Plus D)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. OS was reported for each melanoma dose arm (Parts B plus D).|Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Months||95% Confidence Interval|Median
2693377|NCT01295710|Secondary|Number of Participants With Chronic GVHD Moderate to Severe|Participants with the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks|Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693328|NCT01295827|Secondary|Duration of Response (DOR) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B and D)|For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on IRO with confirmation. The DOR according to RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported for each melanoma dose arm (Parts B plus D).|From time of first documented evidence of CR or PR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment and who demonstrated a confirmed response (CR or PR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Weeks||Full Range|Median
2693329|NCT01295827|Secondary|Disease Control Rate (DCR) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B and D)|DCR was defined as the percentage of participants who had a CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD]). The percentage of participants who experienced a confirmed CR, PR, or SD according to RECIST 1.1 as assessed by IRO was reported as the DCR for each melanoma dose arm (Parts B plus D).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693330|NCT01295827|Secondary|Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to PD-L1 IHC Expression Status in Prior Treatment (TRT)-Naïve and Previously-Treated NSCLC Participants (Parts C Plus F)|"Percent CFB in tumor size based on IRC per RECIST 1.1 was reported according to PD-L1 status in prior treatment-naïve and previously-treated NSCLC participants. Tumor PD-L1 status was measured by TPS, which was the percentage of tumor cells identified using IHC analysis that expressed PD-L1, as follows: TPS ≥50% =tumor strongly positive, TPS of 1%-49% =tumor weakly positive, TPS <1% =tumor considered negative, or TPS unknown. Maximum tumor change for a participant was defined as the percent change of the participant's smallest post-baseline tumor size from baseline. The number of participants in a percent CFB range was reported categorically according to PD-L1 status (TPS ≥50%, TPS = 1-49%, TPS <1%, TPS Unknown). Negative percent CFB values indicate tumor size reduction, with the greatest reduction possible indicated as ≤ -30%. As specified by the protocol, analysis of NSCLC participants was performed according to prior treatment exposure (Treatment Naive and Previously Treated)."|Baseline, last available tumor assessment (up to approximately 53 months through Interim Database cut-off date of 18-Sep-2015)|NSCLC participants that received ≥1 dose of study treatment, had a valid PD-L1 expression measurement, and had both baseline and post-baseline tumor assessments. Per protocol, Part A was not analyzed for biomarker analysis. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Participants|||Count of Participants
2693331|NCT01295827|Secondary|Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to Programmed Death-Ligand 1 (PD-L1) Immunohistochemical (IHC) Expression Status in Ipilimumab (Ipi)-Exposed and Ipi-Naive Melanoma Participants (Parts B Plus D)|"The percent change from baseline in tumor size based on IRC per RECIST 1.1 was reported according to PD-L1 status in Ipi-Exposed and Ipi-Naïve melanoma participants. Tumor PD-L1 status was measured by the tumor proportion score (TPS), which was the percentage of tumor cells identified using IHC analysis that expressed PD-L1. Tumors with ≥1% positive staining for PD-L1 were considered positive. Maximum tumor change was defined as the percent change of the participant's smallest post-baseline tumor size from the baseline. The number of participants in a percent change from baseline range was reported categorically according to PD-L1 status (PD-L1-Positive, PD-L1 Negative, PD-L1 Status Unknown). Negative percent change from baseline values indicate tumor size reduction, with the greatest reduction possible indicated as ≤ -30%. As specified by the protocol, this analysis of melanoma participants was performed according to ipilimumab exposure (Ipi-Exposed and Ipi-Naïve)."|Baseline, last available tumor assessment (up to approximately 53 months through Interim Database cut-off date of 18-Sep-2015)|Melanoma participants that received ≥1 dose of study treatment, had a valid PD-L1 expression measurement, and had both baseline and post-baseline tumor assessments. Per protocol, Part A was not analyzed for biomarker analysis. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Participants|||Count of Participants
2693332|NCT01295827|Secondary|Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F)|Pre-dose samples were collected 24 hours before infusion of pembrolizumab at specified intervals for the determination of Ctrough. Ctrough was defined as the lowest concentration reached by pembrolizumab before the next dose was administered. For the purposes of the Ctrough analysis, samples were collected and analyzed separately for each Part C and F enrolment cohort, and Ctrough was reported for each cohort according to cycle and nominal time after first dose (Day). Results for each cycle reported for arms with N>1 at that timepoint. Ctrough data for solid tumor (Part A) and melanoma (Parts B and D) participants are presented separately and are not included here.|Part C: pre-dose at Cycles 2,5,9,13,17,21 (cycle=21 days); Part F treated every 3 weeks: pre-dose at Cycles 2,3,6,8,12,14,16,24,32 (cycle=21 days); Part F treated every 2 weeks: pre-dose at Cycles 2,3,6,7,8,9,12,16,18,24,32,36,40,48 (cycle=14 days)|All NSCLC participants receiving ≥1 dose of drug and having available samples collected pre-dose before each cycle. Per protocol, Ctrough analyzed separately by Part, dose, and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms (indicated by zero participants analyzed entered in the table).|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2693333|NCT01295827|Secondary|Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D)|Pre-dose samples were collected 24 hours before infusion of pembrolizumab at specified intervals for the determination of Ctrough. Ctrough was defined as the lowest concentration of pembrolizumab reached before the next dose was administered. For the purposes of the Ctrough analysis, samples were collected and analyzed separately for each Part B and D enrolment cohort, and Ctrough was reported for each cohort according to cycle and nominal time after first dose (Day). Results for each cycle reported for arms with N>1 at that timepoint. Ctrough data for solid tumor (Part A) and NSCLC (Parts C and F) participants are presented separately and are not included here.|Part B arms treated every 3 weeks: pre-dose at Cycles 2,5,9,13,17,25,33 (cycle=21 days); Part B treated every 2 weeks: pre-dose at Cycles 2,3,7,13,19,25,31,37 (cycle=14 days); Part D: pre-dose at Cycles 2,3,6,8,12,16,24,32 (cycle=21 days)|All melanoma participants receiving ≥1 dose of drug and having available samples collected pre-dose before each cycle. Per protocol, Ctrough analyzed separately by Part, dose, and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms (indicated by zero participants analyzed entered in the table).|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2693334|NCT01295827|Secondary|Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2)|Pre-dose samples were collected 24 hours before infusion of pembrolizumab at specified intervals for the determination of Ctrough. Ctrough was defined as the lowest concentration of pembrolizumab reached before the next dose was administered. Ctrough was reported for each Part A arm according to cycle and nominal time after first dose (Day). Results for each cycle reported for arms with N>1 at that timepoint. Ctrough data for melanoma (Parts B and D) and NSCLC (Parts C and F) participants are presented separately and are not included here.|Parts A and A1: pre-dose at Cycles 2, 4, 6, 8, 10, 12, 14 (cycle=14 days); A2 Cohorts: pre-dose at Cycles 2, 3, 5, 7, 9, 11 (cycle=21 days)|All Part A participants receiving ≥1 dose of drug and having available Ctrough samples collected pre-dose before each cycle. Due to differing dosing schedules or N<1, some time points were not applicable for certain arms if data were not collected or analyzed (indicated by zero participants analyzed entered in the table).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2693335|NCT01295827|Secondary|Area Under the Concentration-Time Curve of Pembrolizumab From Day 21 to Day 42 (AUC21-42) in Solid Tumor Participants (Part A2)|Blood samples were collected at specified intervals for the determination of AUC21-42. AUC21-42 was defined as the area under the concentration-time curve of pembrolizumab from Study Day 21 (end of Cycle 1) through Study Day 42 (end of Cycle 2). AUC21-42 was based on noncompartmental analysis and reported for participants in Part A2.|Cycle 1: Day 21; Cycle 2: Day 1: Pre-dose, post-dose at 0.5 and 24 hours, Day 3, Day 8, Day 15 (Cycle = 21 days)|All participants in Part A2 receiving escalating doses of drug during Cycle 1 and having available AUC21-42 data during Cycle 2. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A, A1, B, C, D, C, and F were not included in the escalating dose PK analysis.|||μg•day/mL||Geometric Coefficient of Variation|Geometric Mean
2693336|NCT01295827|Secondary|Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Day 21 (AUC 0-21) in Solid Tumor Participants (Part A2)|Blood samples were collected at specified intervals for the determination of AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of pembrolizumab from time zero to Study Day 21. AUC0-21 was based on noncompartmental analysis and reported for participants in Part A2.|Cycle 1: Day 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours; Day 5, Day 8: pre- and post-dose; Day 15 (Cycle = 21 days)|All participants in Part A2 receiving escalating doses of drug during Cycle 1 (21 days) and having available AUC0-21 data. One participant was excluded from analysis due to discontinuation. Per protocol, participants in Parts A, A1, B, C, D, C, and F were not included in the escalating dose PK analysis.|||μg•day/mL||Geometric Coefficient of Variation|Geometric Mean
2693337|NCT01295827|Secondary|Terminal Half-Life (t ½) of Pembrolizumab in Solid Tumor Participants (Parts A and A1)|Blood samples were collected at specified intervals for the determination of t½. t½ was defined as the time required to divide the pembrolizumab plasma concentration by two after reaching pseudo-equilibrium, following a single dose of pembrolizumab. t½ was based on noncompartmental analysis and reported for participants in Parts A and A1.|Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)|All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available t½ data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
2693338|NCT01295827|Secondary|Time to Maximum Concentration (Tmax) of Pembrolizumab in Solid Tumor Participants (Parts A and A1)|Blood samples were collected at specified intervals for the determination of Tmax. Tmax was defined as time to the maximum concentration of pembrolizumab reached. Tmax was based on noncompartmental analysis and reported for participants in Parts A and A1.|Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)|All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available Tmax data. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.|||days||Full Range|Median
2693339|NCT01295827|Secondary|Maximum Concentration (Cmax) of Pembrolizumab in Solid Tumor Participants (Parts A and A1)|Blood samples were collected at specified intervals for the determination of Cmax. Cmax was defined as the maximum concentration of pembrolizumab reached. Cmax was based on noncompartmental analysis and reported for participants in Parts A and A1.|Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)|All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available Cmax data. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2693361|NCT01295710|Post-Hoc|Chronic GVHD Mild to Severe by Conditioning Regimen|Participants with the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693340|NCT01295827|Secondary|Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Infinity (AUC 0-inf) in Solid Tumor Participants (Parts A and A1)|Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of pembrolizumab from time zero to infinity. AUC0-inf was based on noncompartmental analysis and reported for participants in Parts A and A1.|Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)|All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC0-inf data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis.|||μg•day/mL||Geometric Coefficient of Variation|Geometric Mean
2693341|NCT01295827|Secondary|Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Day 28 (AUC 0-28) in Solid Tumor Participants (Parts A and A1)|Blood samples were collected at specified intervals for the determination of AUC0-28. AUC0-28 was defined as the area under the concentration-time curve of pembrolizumab from time zero to Day 28. AUC0-28 was based on noncompartmental analysis and reported for participants in Parts A and A1.|Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days)|All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC0-28 data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose pharmacokinetic (PK) analysis.|||μg•day/mL||Geometric Coefficient of Variation|Geometric Mean
2693342|NCT01295827|Secondary|ORR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F)|ORR was defined as the percentage of participants in the analysis population who had a confirmed irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or irPR (decrease in sum of the products of the two largest perpendicular diameters (SPD) of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC. The percentage of participants who experienced a confirmed irCR or irPR according to irRC as assessed by the investigator was reported as the ORR for each NSCLC dose arm (Parts C plus F).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693343|NCT01295827|Secondary|ORR According to Immune-related Response Criteria (irRC) as Assessed by Investigator in Melanoma Participants (Parts B Plus D)|ORR was defined as the percentage of participants in the analysis population who had a confirmed immune-related Complete Response (irCR: complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or immune-related Partial Response (irPR: decrease in sum of the products of the two largest perpendicular diameters (SPD) of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC. The percentage of participants who experienced a confirmed irCR or irPR according to irRC as assessed by the investigator was reported as the ORR for each melanoma dose arm (Parts B plus D).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693344|NCT01295827|Primary|ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F)|ORR was defined as the percentage of participants in the analysis population who had a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRC was reported as the ORR for each NSCLC dose arm (Parts C plus F).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693345|NCT01295827|Primary|Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D)|ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRO was reported as the ORR for each melanoma dose arm (Parts B plus D).|Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)|All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2693346|NCT01295827|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced an AE was reported for each arm.|Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)|All participants who received at least 1 dose of study treatment.|||Participants|||Number
2693362|NCT01295710|Post-Hoc|Overall Survival by Conditioning Regimen|Incidence of death from any cause. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693347|NCT01295827|Primary|Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1)|DLTs were assessed according to NCI-CTCAE v.4.0 during the first cycle (28 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥14 days; Gr 3 nonhematologic toxicity lasting >3 days despite optimal supportive care; any Grade 3 non-hematologic laboratory value if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for >1 week; Gr 3 or 4 febrile neutropenia; thrombocytopenia <25,000 cells/mm^3 (if associated with a bleeding event requiring an elective platelet transfusion, or a life-threatening bleeding event which resulted in urgent intervention and admission to an Intensive Care Unit); or Gr 5 toxicity. The number of participants in Part A and Part A1 with a DLT were reported by pembrolizumab dose received.|Up to 28 days in Cycle 1|All participants in Parts A and A1 who received ≥1 dose of study treatment and either 1) had a DLT in Cycle 1 or 2) received ≥90% of the prescribed dose of pembrolizumab in Cycle 1 and completed all safety evaluations ≥28 days after the first administration of pembrolizumab without experiencing DLT. Per protocol, Parts A2 and B-F were not analyzed.|||Participants|||Number
2693348|NCT01295814|Secondary|Global Response Assessment (GRA)|"Percent(%) of patients who reported 50% or greater overall improvement in their condition.~Score on a scale range (improvement 0%-100%)"|Measured at12 Weeks||||percentage of participants|||Number
2693349|NCT01295814|Secondary|Pelvic Pain Urgency/Frequency (PUF) Score|Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)|Baseline12 Weeks||||units on a scale||Standard Deviation|Mean
2693350|NCT01295814|Secondary|Interstitial Cystitis Problem Index (ICPI)|Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)|Baseline/12 Weeks||||units on a scale||Standard Deviation|Mean
2693351|NCT01295814|Secondary|Interstitial Cystitis Symptom Index (ICSI)|Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)|Baseline/ 12 weeks||||units on a scale||Standard Deviation|Mean
2693352|NCT01295814|Primary|O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score|Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)|Baseline/12 Weeks||||units on a scale||Standard Deviation|Mean
2693353|NCT01295710|Post-Hoc|Transplant-related Mortality by Conditioning Regimen|Participants with transplant related mortality. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693354|NCT01295710|Post-Hoc|Disease-free Survival by Conditioning Regimen|Incidence of relapse or death. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693355|NCT01295710|Post-Hoc|Relapse by Conditioning Regimen|Participants with relapse or disease recurrence, with death as competing risk. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the occurrence of relapse with death as competing risk, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693356|NCT01295710|Post-Hoc|Acute GVHD Grade III-IV by Conditioning Regimen|Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of acute GVHD grade III-IV, with death and re transplantation as competing risks, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693357|NCT01295710|Post-Hoc|Acute GVHD Grade II-IV by Conditioning Regimen|Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of acute GVHD grade II-IV, with death and re transplantation as competing risks, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693358|NCT01295710|Post-Hoc|Acute GVHD Grade I-IV by Conditioning Regimen|Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of acute GVHD grade I-IV, with death and re transplantation as competing risks, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693359|NCT01295710|Post-Hoc|Chronic GVHD Severe by Conditioning Regimen|Participants with the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693360|NCT01295710|Post-Hoc|Chronic GVHD Moderate to Severe by Conditioning Regimen|Participants with the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693363|NCT01295710|Post-Hoc|Grade III-IV Acute GVHD-free GRFS by Conditioning Regimen|Participants with grade III-IV acute GVHD as determined by the Investigator, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the occurrence of grade III-IV acute GVHD, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693364|NCT01295710|Post-Hoc|Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS) by Conditioning Regimen|Participants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693365|NCT01295710|Post-Hoc|Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD or Death From Any Cause by Conditioning Regimen|Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause. Analysis was conducted by conditioning regimen.|Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, or death from any cause, assessed up to 48 months|Analysis of patients who received a specific conditioning regimen|||Participants|||Count of Participants
2693366|NCT01295710|Post-Hoc|Grade III-IV Acute GVHD-free, GRFS|Participants with grade III-IV acute GVHD as determined by the Investigator, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause|Time from first study drug administration until the occurrence of grade III-IV acute GVHD, moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death, assessed up to 48 months||||Participants|||Count of Participants
2693367|NCT01295710|Post-Hoc|Moderate to Severe Chronic GVHD-free, Relapse-free Survival (GRFS)|Participants with moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause|Time from first study drug administration until the occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, relapse or death from any cause, assessed up to 48 months||||Participants|||Count of Participants
2693368|NCT01295710|Post-Hoc|Number of Participants With First Occurrence of Moderate or Severe Chronic GVHD According to 2005 NIH Criteria as Determined by Principal Investigator or Death From Any Cause After Allogeneic Stem Cell Transplantation|Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD or death|Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators or death from any cause, assessed up to 48 months||||Participants|||Count of Participants
2693369|NCT01295710|Secondary|Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD|Participants who started on systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks|Time from first study drug administration until start of systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693370|NCT01295710|Secondary|Number of Participants With Transplant Related Mortality|Participants with transplant related mortality|Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months||||Participants|||Count of Participants
2693371|NCT01295710|Secondary|Disease-free Survival|Incidence of relapse or death|Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months||||Participants|||Count of Participants
2693372|NCT01295710|Secondary|Number of Participants With Relapse|Participants with relapse or disease recurrence, with death as competing risk|Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months||||Participants|||Count of Participants
2693373|NCT01295710|Secondary|Number of Participants With Acute GVHD Grade III-IV|Participants with the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks|Time from first study drug administration until the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693374|NCT01295710|Secondary|Number of Participants With Acute GVHD Grade II-IV|Participants with the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks|Time from first study drug administration until the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693375|NCT01295710|Secondary|Number of Participants With Acute GVHD Grade I-IV|Participants with the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks|Time from first study drug administration until the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693400|NCT01295320|Secondary|Number of Subjects With Any Fatal SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 48 to Month 72||||Participants|||Count of Participants
2693378|NCT01295710|Secondary|Number of Participants With Chronic GVHD Mild to Severe|Participants with the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks|Time from first study drug administration until the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months||||Participants|||Count of Participants
2693379|NCT01295710|Secondary|Overall Survival|Incidence of death from any cause|Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months||||Participants|||Count of Participants
2693380|NCT01295710|Primary|Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD According to 2005 NIH Criteria as Determined by the Independent Endpoint Committee or Death From Any Cause After Allogeneic Stem Cell Transplantation|Participants with first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee or death from any cause after allogeneic stem cell transplantation, with a target of 124 total events of moderate or severe chronic GVHD, or death from any cause|Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Independent Endpoint Committee, or death from any cause, assessed up to 48 months||||Participants|||Count of Participants
2693381|NCT01295671|Secondary|Preference for Sweet Taste|We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite.|12 Month|Data missing for 1 subject in SSB group.|||Sample number||Inter-Quartile Range|Median
2693382|NCT01295671|Secondary|Diet Quality: Sugar-Sweetened Beverage Consumption|Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day|12 Month|Data missing for 1 subject in USB group.|||Servings per day||Standard Deviation|Mean
2693383|NCT01295671|Secondary|Body Weight|Body Weight|12 Month|Data missing for 1 subject in ASB group.|||kg||Standard Deviation|Mean
2693384|NCT01295671|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|12 Month||||mmHg||Standard Deviation|Mean
2693385|NCT01295671|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|12 Month||||mmHg||Standard Deviation|Mean
2693386|NCT01295671|Secondary|ALT|ALT|12 Month||||U/L||Inter-Quartile Range|Median
2693387|NCT01295671|Secondary|Uric Acid|Uric Acid|12 Month||||mg/dL||Standard Deviation|Mean
2693388|NCT01295671|Secondary|Fibrinogen|Fibrinogen|12 Month||||mg/dL||Standard Deviation|Mean
2693389|NCT01295671|Secondary|hsCRP|hsCRP|12 Month||||mg/L||Inter-Quartile Range|Median
2693390|NCT01295671|Secondary|LDL-C|LDL-C|12 Month||||mg/dL||Standard Deviation|Mean
2693391|NCT01295671|Primary|Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)||12 Month||||ratio of Triglycerides-to-HDL||Inter-Quartile Range|Median
2693392|NCT01295515|Primary|Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)|Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects C-C chemokine receptor type 5 (CCR5) DNA.|week 4 (post) compared to week 0 (pre)|A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.|||# of copies of DNA/million cells|||Number
2693393|NCT01295515|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events.|Here is the count of participants with serious and non-serious adverse events assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events for severity (mild/moderate/severe), expectedness (expected/unexpected), and relatedness to study drug (definitely, probably, possibly, unlikely, or unrelated).|Date consent signed to date off study, approximately 66 months and 2 days.||||Participants|||Count of Participants
2693394|NCT01295515|Secondary|Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals|The outcome measure is copies of HIV RNA per ml of plasma. HIV RNA levels are measured using a polymerase chain reaction method.|week 4 (post) compared to week 0 (pre)|Median and standard deviation were calculated using multiple samples from each participant. On patient #5 there was an error with the machine when the samples were ran and they did not have any other samples to rerun it. Patient #5 will not be analyzed since there is no more samples.|||copies/ml||Standard Deviation|Median
2693395|NCT01295515|Secondary|Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy|The outcome measure is the fold change in the ratio of HIV RNA to HIV DNA. For the pre and post interferon time point, the level of HIV RNA is divided by the level of HIV DNA and this ratio of the HIV RNA/DNA pre and post interferon is calculated to yield the fold change in HIV RNA/DNA levels. Fold change does not have units.|week 4 (post) and week 0 (pre)|A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.|||fold change|||Number
2693396|NCT01295515|Primary|Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)|Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects RNA.|week 4 (post) compared to week 0 (pre)|A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.|||# of copies of HIV RNA/million cells|||Number
2693397|NCT01295320|Secondary|Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented||Month 48 to Month 72||||Participants|||Count of Participants
2693398|NCT01295320|Secondary|Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented||Month 48 to Month 72||||Participants|||Count of Participants
2693399|NCT01295320|Secondary|Number of Subjects With Any Suspected Cases of HZ Episodes||Month 48 to Month 72||||Participants|||Count of Participants
2693789|NCT01292005|Primary|Change in Tumor Necrosis Factor (TNF)-Alpha|Normal value range for TNF alpha = 0 - 22 pg/ml.|baseline, Day 1, Day 3||||pg/ml||Full Range|Median
2693401|NCT01295320|Secondary|Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 0 to Month 72||||Participants|||Count of Participants
2693402|NCT01295320|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 48 to Month 72||||Participants|||Count of Participants
2693403|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 72|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||mIU/ml||95% Confidence Interval|Geometric Mean
2693404|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 60|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||mIU/ml||95% Confidence Interval|Geometric Mean
2693405|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 48|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||mIU/ml||95% Confidence Interval|Geometric Mean
2693406|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 72|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||cells/million T-cells||Standard Deviation|Mean
2693407|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 60|The analysis was base don the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||cells/million T-cells||Standard Deviation|Mean
2693408|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|-Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 48|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||cells/million T-cells||Standard Deviation|Mean
2693409|NCT01295281|Secondary|Perception of Discomfort Due to Other Causes|To compare subject's tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively|||||||
2693410|NCT01295281|Secondary|Perception of Resistance|To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693411|NCT01295281|Secondary|Perception of Smoothness|To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693412|NCT01295281|Secondary|Perception of Slipperiness|To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693413|NCT01295281|Secondary|Perception of Catheter Tip|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2701398|NCT01235338|Primary|Cmax of d-Amphetamine|d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
2693414|NCT01295281|Secondary|Perception of Catheter Adherence|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693415|NCT01295281|Secondary|Perception of Catheter Eyes|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693416|NCT01295281|Secondary|Perception of Stiffness/ Rigidity|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693417|NCT01295281|Secondary|"Perception of Other Discomfort"|"To compare subject's tolerability with regards to perceived other discomfort, when using two different urinary catheters; PVC vs. POBE 2.0. Frequency of other discomfort (yes/ no) will be assessed in patient questionnaire. The frequency of other discomfort will be compared between the treatments. Other discomfort will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject)."|At 7 and 14 days after randomization, respectively|||||||
2693418|NCT01295281|Secondary|Presence of Bleeding|To compare subject's tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693419|NCT01295281|Secondary|Perception of Burning Sensation|To compare subject's tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693420|NCT01295281|Secondary|Perception of Pain|To compare subject's tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
2693421|NCT01295281|Primary|Number of Participants With Discomfort|The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.|At 7 and 14 days after randomization, respectively|"Since the study is cross-over, all (104) subjects evaluated both LoFric POBE 2.0 and LoFric PVC. To be able to group and describe the results the Arm/Group Titles are renamed in this section to LoFric POBE 2.0 and LoFric PVC respectively. Each Arm/Group describing the outcome for all 104 subjects (ITT analysis set)."|||participants|||Number
2693422|NCT01295216|Secondary|Change From Baseline in Physical Activity at 12 Months||Baseline and 12 months||||MET/min/week||95% Confidence Interval|Mean
2693423|NCT01295216|Secondary|Change From Baseline in Waist Circumference at 12 Months||Baseline and 12 months||||cm||95% Confidence Interval|Mean
2693424|NCT01295216|Secondary|Change From Baseline in Body Mass Index at 12 Months||Baseline and 12 months||||kg/m2||95% Confidence Interval|Mean
2693425|NCT01295216|Secondary|Change From Baseline in Body Weight at 12 Months||Baseline and 12 months||||kg||95% Confidence Interval|Mean
2693426|NCT01295216|Secondary|Change From Baseline in Food Intake at 12 Months||Baseline and 12 months||||Servings/day||95% Confidence Interval|Mean
2693427|NCT01295216|Primary|Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months|A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time|Baseline, 6, 12, and 18 months||||mmHg||95% Confidence Interval|Mean
2693428|NCT01295112|Secondary|The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24|Change in BCVA at Week 24 from baseline|24 weeks||||letters||Standard Deviation|Mean
2693429|NCT01295112|Primary|The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks||24 weeks||||Participants|||Count of Participants
2693430|NCT01295034|Secondary|CD4+T Cell Count|The change in the CD4+T cell count between the two arms.|baseline and 12 months|Analysis only for participants who completed the study.|||cell/μL||Inter-Quartile Range|Median
2693431|NCT01295034|Primary|25(OH)D Levels|The difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms.|baseline and 12 months||||Participants|||Count of Participants
2693432|NCT01294917|Secondary|Dryness|This will be assessed by the tear break-up time on the lens surface, measured in seconds.|4 weeks|||||||
2693433|NCT01294917|Secondary|Subjective Lens Wearing Comfort|This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.|4 weeks|||||||
2693434|NCT01294917|Primary|Corneal Staining|Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.|4 weeks|Only subjects that completed all three arms were included in analysis.|||units on a scale||Standard Deviation|Mean
2693435|NCT01294800|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 12 Weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug|||Participants|||Number
2693436|NCT01294800|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 14 weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug|||Participants|||Number
2693437|NCT01294800|Secondary|"Change From Baseline in Mean On Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12"|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|FAS population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.|||Hours/Day||Standard Deviation|Mean
2693438|NCT01294800|Secondary|"Percentage of Participants With ≥30% Reduction in Off Time at Week 12"|"The proportion of responders (≥30% Reduction in Off Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval."|Up to 12 Weeks|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.|||Percentage of participants|||Number
2693439|NCT01294800|Primary|"Change From Baseline in Mean Off Time (Hours Per Day) at Week 12"|"The on state is defined as the period of time during which a participant's symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.|||Hours/Day||Standard Deviation|Mean
2693440|NCT01294787|Secondary|Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo|The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).|Day 1|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Seconds||Standard Error|Least Squares Mean
2693441|NCT01294787|Secondary|Exercise Endurance Comparison Between QVA149 and Tiotropium Groups|Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Seconds||Standard Error|Least Squares Mean
2693442|NCT01294787|Secondary|Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Error|Least Squares Mean
2693443|NCT01294787|Secondary|Exertional Dyspnea Comparison Between QVA149 and Placebo Groups|"The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement."|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Error|Least Squares Mean
2693459|NCT01294748|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, MI or repeat revascularization of the target lesion pre-hospital discharge.|8 hours||||percentage of participants|||Number
2693444|NCT01294787|Secondary|Spirometry After Three Weeks of Treatment on Patients Not Exercising|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693445|NCT01294787|Secondary|Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693446|NCT01294787|Secondary|Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Kilo Pascal per second||Standard Error|Least Squares Mean
2693447|NCT01294787|Secondary|Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693448|NCT01294787|Secondary|Pulmonary Function Test Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693449|NCT01294787|Secondary|Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693450|NCT01294787|Secondary|Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693451|NCT01294787|Secondary|Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2693452|NCT01294787|Primary|Exercise Tolerance Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Seconds||Standard Error|Least Squares Mean
2693453|NCT01294748|Secondary|Stent Thrombosis (Definite/Probable)|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|9-months||||percentage of patients|||Number
2693454|NCT01294748|Secondary|Target Lesion Failure (TLF)|Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization|9-months||||percentage of patients|||Number
2693455|NCT01294748|Secondary|Target Vessel Failure (TVF)|Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization|9-months||||percentage of patients|||Number
2693456|NCT01294748|Secondary|Clinically-driven Target Lesion Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.|9-months||||percentage of patients|||Number
2693457|NCT01294748|Secondary|Total Myocardial Infarct (MI)|"Q-wave MI (QWMI): requires one of the following criteria: development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x ULN elevation of CK levels; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.~Non-Q-wave MI (NQWMI):the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels (≥3 times ULN) in the absence of new pathologic Q waves.~Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post -PCI, with a normal CK-MB at baseline."|9-months||||percentage of patients|||Number
2693458|NCT01294748|Secondary|Total Mortality||9-months||||percentage of patients|||Number
2693460|NCT01294748|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.|8 hours||||percentage of participants|||Number
2693464|NCT01294709|Secondary|Time to 1 mm ST Segment Depression|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant's ECG, symptoms, and arm blood pressure were continuously monitored. The ECG was reviewed and the time to the first ST segment depression of 1 mm was recorded.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of time to 1 mm ST segment depression available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.|||seconds||95% Confidence Interval|Least Squares Mean
2693465|NCT01294709|Secondary|ST Segment Depression at Peak Exercise|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant's ECG, symptoms, and arm blood pressure were continuously monitored. The time of peak exercise was considered the time at which the participant reached at least one of the criteria for stopping the treadmill test (evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia). The ECG for that timepoint (time of peak exercise) was evaluated and the amount of ST segment depression was determined.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of ST segment depression at peak exercise available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.|||mm||95% Confidence Interval|Least Squares Mean
2693466|NCT01294709|Primary|Total Exercise Duration on the Treadmill Test|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant's electrocardiogram (ECG), symptoms, and arm blood pressure were continuously monitored. Regardless of whether the participant believed he or she could continue, the test was discontinued upon evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable treadmill exercise duration data available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.|||Seconds||95% Confidence Interval|Least Squares Mean
2693467|NCT01294709|Primary|Number of Participants With Laboratory Adverse Events|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.|||Participants|||Number
2693468|NCT01294709|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.|||Participants|||Number
2693469|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 12|The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12.|||Percentage of Participants|||Number
2693470|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 9|The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9.|||Percentage of Participants|||Number
2693498|NCT01294644|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
2693471|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 6|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6.|||Percentage of Participants|||Number
2693472|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 3|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3.|||Percentage of Participants|||Number
2693473|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1|Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 1|The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1.|||Percentage of Participants|||Number
2693474|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Baseline (Day 1)|The population consisted of all participants for which WOMAC VA 3.0 data for joint stiffness and limiation in physical function were available at Baseline.|||Percentage of Participants|||Number
2693475|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Month 12|The population consisted of all participants for which a BPI value was avaialble at Month 12.|||Percentage of Participants|||Number
2693476|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Baseline (Day 1)|The population consisted of all participants for which a BPI value was available at baseline.|||Percentage of Participants|||Number
2693477|NCT01294683|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who were discontinued from the study due to an AE were recorded.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2693513|NCT01294579|Secondary|Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS)|Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates.|Baseline up to approximately 30 months||||months||95% Confidence Interval|Median
2693478|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2693479|NCT01294683|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2693480|NCT01294683|Secondary|Percentage of Participants With New Onset of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an AE related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2693481|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2693482|NCT01294683|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
2693483|NCT01294683|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
2693484|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
2693485|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
2693486|NCT01294683|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) and throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|Up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
2693487|NCT01294683|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.~Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
2693488|NCT01294683|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.~Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
2693489|NCT01294644|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
2693490|NCT01294644|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
2693491|NCT01294644|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:~How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
2693492|NCT01294644|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
2693493|NCT01294644|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||percentage of participants|||Number
2693494|NCT01294644|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||mm||Standard Deviation|Mean
2693495|NCT01294644|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
2693496|NCT01294644|Secondary|Change From Baseline in CR-SMFRS Score|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
2693497|NCT01294644|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.~The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
2702300|NCT01227785|Primary|Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported at 1-month post-implant|1-month|73 CRT-D patients had data available at 1-month visit|||Ohms||Standard Deviation|Mean
2693499|NCT01294644|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population which included all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants|||Number
2693500|NCT01294592|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization|A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs.|Up to 2 years|ITT Population|||Participants|||Number
2693501|NCT01294592|Secondary|Exposure to Study Drug|Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.|Up to 2 years|Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date|||days||Standard Deviation|Mean
2693502|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Participants|||Number
2693503|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Participants|||Number
2693504|NCT01294592|Secondary|Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries|BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate [TURP], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.|Up to Month 24|ITT Population|||Participants|||Number
2693505|NCT01294592|Secondary|Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH|"CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group."|Up to Month 24|ITT Population|||Participants|||Number
2693514|NCT01294579|Secondary|Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)|Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to >2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to >2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to >2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis >1.5 cm.|Baseline up to approximately 30 months||||percentage of participants|||Number
2693506|NCT01294592|Secondary|Number of Events of Clinical Progression (CP) of BPH|The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.|Up to 2 years|ITT Population. Only those participants at risk for CP at the specified visit were analyzed.|||Events|||Number
2693507|NCT01294592|Secondary|Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"Each participant was asked the following question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. This response was rated from 0 (delighted) to 6 (terrible). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Scores on a scale||Standard Error|Least Squares Mean
2693508|NCT01294592|Secondary|Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Scores on a scale||Standard Error|Least Squares Mean
2693509|NCT01294592|Secondary|Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.|||Participants|||Number
2693510|NCT01294592|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach|"The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Scores on a scale||Standard Error|Least Squares Mean
2693511|NCT01294579|Secondary|All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months|Deaths were collected and were considered to be an on treatment death up to 60 days post treatment.|Baseline up to approximately 30 months||||participants|||Number
2693512|NCT01294579|Secondary|Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell|Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done.|up to 30 months|||||||
2693545|NCT01294423|Primary|Adjusted Mean Change in HbA1c Levels|To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
2693515|NCT01294579|Secondary|Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS)|Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine|Partial response in induction phase up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
2693516|NCT01294579|Secondary|Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS)|The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: > or = to 50% decrease from baseline in target nodules; > or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease.|Baseline up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
2693517|NCT01294579|Primary|Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS)|Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and >1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.|Baseline up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
2693518|NCT01294553|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion.|41.4 weeks|ITT Population|||participants|||Number
2693519|NCT01294553|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|41.4 weeks|ITT Population|||participants|||Number
2693520|NCT01294553|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|41.4 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments|||participants|||Number
2693521|NCT01294514|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation|The Covidien Nellcor Respiration Rate Software shall calculate respiration rate as mean error of +/- standard deviation.|Overall average|One participant was excluded from the data analysis based on cardiac arrhythmia|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
2693522|NCT01294514|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.~The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average of 30 minute periods|One participant was excluded from the data analysis based on cardiac arrhythmia|||Breaths Per Minute (BrPM)|||Number
2693523|NCT01294514|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.|Participants were monitorerd on average of 30 minute period|One participant was excluded from the analysis based on cardiac arrhythmia|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
2693524|NCT01294462|Secondary|Composite of All-cause Mortality, MI or Stroke|Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data|||Percent probability|||Number
2693525|NCT01294462|Secondary|Major and Minor Bleeding|Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data|||Percent probability|||Number
2693526|NCT01294462|Primary|Major Adverse Cardiac Events (MACE)|Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data|||Percent probability|||Number
2693527|NCT01294462|Primary|Major Bleeding|Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data|||Percent probability|||Number
2693528|NCT01294449|Primary|All-Cause Mortality|Outcome measured for total population. Not broken down by indication received.|5 years||||participants|||Number
2693529|NCT01294436|Other Pre-specified|Mean Change in Body Weight|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value|||kg||95% Confidence Interval|Mean
2693530|NCT01294436|Other Pre-specified|Mean Change in HbA1c Levels|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value|||Percent||95% Confidence Interval|Mean
2693531|NCT01294436|Primary|Mean Change in Seated Systolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mmHg||Standard Deviation|Mean
2693532|NCT01294436|Primary|Mean Change in Seated Diastolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mmHg||Standard Deviation|Mean
2693533|NCT01294436|Primary|Mean Change in Seated Heart Rate|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||beats per minute (bpm)||Standard Deviation|Mean
2693534|NCT01294436|Primary|Mean Change in Serum Uric Acid|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mg/dL||Standard Error|Mean
2693535|NCT01294436|Primary|Mean Change in Magnesium|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mEq/L||Standard Error|Mean
2693536|NCT01294436|Primary|Mean Change in Blood Urea Nitrogen (BUN)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mg/dL||Standard Error|Mean
2693537|NCT01294436|Primary|Mean Change in Aspartate Aminotransferase (AST)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||U/L||Standard Error|Mean
2693538|NCT01294436|Primary|Mean Change in Alanine Aminotransferase (ALT)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||U/L||Standard Error|Mean
2693539|NCT01294436|Primary|Mean Change in Hematocrit|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||Percent||Standard Error|Mean
2693540|NCT01294436|Primary|Proportion of Participants With At Least One Episode of Hypoglycemia|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia|Long-term treatment up to 52 weeks|Safety Analysis Set|||Percentage of participants|||Number
2693541|NCT01294436|Primary|Proportion of Participants With Serious Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set|||Percentage of participants|||Number
2693542|NCT01294436|Primary|Proportion of Participants With Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set|||Percentage of participants|||Number
2693543|NCT01294423|Secondary|Adjusted Mean Change in Body Weight|To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2693544|NCT01294423|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2693550|NCT01294397|Primary|Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept|The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained).|Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available AUC data|||day*μg/mL||Standard Deviation|Mean
2693551|NCT01294384|Secondary|Change From Baseline in Schirmer Test|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||mm||Standard Deviation|Mean
2693552|NCT01294384|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2693553|NCT01294384|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2693554|NCT01294384|Secondary|Change From Baseline in Tear Break-Up Time (TBUT)|TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Seconds||Standard Deviation|Mean
2693555|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Percentage of participants|||Number
2693556|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Percentage of participants|||Number
2693557|NCT01294384|Secondary|Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness|The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||millimeters||Standard Deviation|Mean
2693558|NCT01294384|Primary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2693559|NCT01294371|Secondary|Participants With Estrogen Deficiency Symptoms|"Estrogen deficiency symptoms include:~hot flashes,~headaches,~palpitations at rest,~insomnia,~fluctuation of mood."|6 months|Full Analysis Set|||participants|||Number
2693560|NCT01294371|Secondary|Percent Compliance to Treatment With Leuprorelin|Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.|6 months|Participants who received at least one dose of leuprorelin.|||percent compliance||Standard Deviation|Mean
2693561|NCT01294371|Primary|Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment|The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.|6 months|Full Analysis Set included all all patients who had signed the personal authorization form and who administered at least one dose of leuprorelin and who had attended at least one post-baseline visit.|||percentage of participants|||Number
2693572|NCT01294358|Primary|Number of Participants With Dose Limiting Toxicity (DLT )|Here is the number of participants with DLT. DLT is defined as follows: All grade 3 or greater toxicities with the exception of Grade 3 constitutional symptoms that persist for less than 72 hours, Grade 3 and 4 myelosuppression (neutrophils and thrombocytopenia) of less than 5 days duration. Grade 3 metabolic/laboratory events that are correctable within 24 hours. Events that are assessed by the principal investigator as clearly unrelated to the agent will not be considered DLTs (e.g., events directly related to catheter insertion, pain related to underlying disease).|Cycle 1 (4 weeks), for up to 6 cycles||||Participants|||Count of Participants
2693562|NCT01294358|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned|Date treatment consent signed to date off study, approximately 2 years and 2 months and 21 days||||Participants|||Count of Participants
2693563|NCT01294358|Secondary|Number of Potential Selection Criteria to Be Used in Future Studies for Patients With Marginally Unresectable Or Unresectable Locally-Advanced Pancreatic Cancer|Number of selection criteria that can be used for unresectable pancreatic cancer.|up to 2.5 years|Data was not collected and this outcome measure was not done due to an insufficient number of participants enrolled in this study.||||||
2693564|NCT01294358|Secondary|Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer|Resectability is defined by the MD Anderson Resectability criteria: Resectable is no extension; normal fat plane between the tumor and the artery (superior mesenteric artery (SMA)). No extension (celiac axis/hepatic artery). Patent (superior mesenteric vein/portal vein (SMV/PV)). Borderline resectable is tumor abutment ≤180◦ (one half or less) of the circumference of the artery; periarterial stranding and tumor points of contact forming a convexity against the vessel improve chances of resection (SMA). Short-segment encasement/abutment of the common hepatic artery (typically at the gastroduodenal origin) (celiac axis/hepatic artery). Short-segment occlusion with suitable vessel above and below (SMV/PV). Locally advanced is encased (>180◦) (SMA). Encased and no technical option for reconstruction usually because of extension to the celiac axis/splenic/left gastric junction or the celiac origin (celiac axis/hepatic artery). Occluded and no technical option for reconstruction (SMV/PV).|4 months||||Participants|||Count of Participants
2693565|NCT01294358|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time between the first day of treatment to the day of death.|Overall survival was assessed through study completion, an average of 3 years.||||Months||Full Range|Median
2693566|NCT01294358|Secondary|Median Time to Progression|Time to progression is the time between the first day of treatment to the day of disease progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions.|From first day of treatment to the day of progression, assessed up to 221 months||||Months||Full Range|Median
2693567|NCT01294358|Secondary|Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)|Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|Every 2 cycles (8 weeks), up to 18 weeks||||Participants|||Count of Participants
2693568|NCT01294358|Secondary|Response Rate Using Magnetic Resonance Imaging (MRI)|Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|Every 2 cycles (8 weeks), up to 18 weeks|This outcome measure was not done. No MRI data were collected. All patients had contrast-enhanced computed tomography (CTs,) and thus were followed for consistency reasons with CT and not MRI.||||||
2693569|NCT01294358|Secondary|Response Rate Using Positron Emission Tomography (PET)|Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|Every 2 cycles (8 weeks), up to 18 weeks|Data was collected for this outcome measure but not analyzed because PET scans were inconsistently obtained. There was lack of scans pre-onstudy or while patient was on treatment. Without being able to make a pre-versus-on treatment comparison, this outcome measure was not done.||||||
2693570|NCT01294358|Secondary|Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|Every 2 cycles (8 weeks), up to 18 weeks||||Participants|||Count of Participants
2693571|NCT01294358|Primary|MTD (Maximum Tolerated Dose)|The MTD is the highest dose that induces dose limiting toxicity (DLT) in no more than 2 patients among a cohort of 6 patients. If 1 or fewer patients experience dose limiting toxicity than the dose level will define the MTD. Only DLT's that occurred during cycle 1 of each dose level were used to determine the MTD.|Cycle 1 (4 weeks), for up to 6 cycles||||mg/ml/24h|||Number
2693574|NCT01294319|Primary|Proportion of Suppressors After Dexamethasone|"All subjects will take 0.25mg dexamethasone as an outpatient between 2300 and 2400h and will then report to the clinic by 0800h next day for the final visit.~At the final visit, cortisol response to dexamethasone suppression was assessed. The cortisol response was dichotomized (suppression vs. non-suppression, using 1.8 ug/dL as the cutoff point) and compared between the two groups,Sedentary Young Adults and Endurance-trained Young Athletes."|cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight||||Participants|||Count of Participants
2693575|NCT01294306|Secondary|Median Overall Survival|Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.|Up to 2 Years||||Months||95% Confidence Interval|Median
2693576|NCT01294306|Secondary|Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride|Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Time Frame: Up to 2 years||||participants|||Number
2693577|NCT01294306|Secondary|Median Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||Months||95% Confidence Interval|Median
2693578|NCT01294306|Primary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR|Up to 2 years||||percentage of subjects|||Number
2693579|NCT01294306|Primary|Disease-control Rate|Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|At 12 weeks||||percentage of subjects|||Number
2693580|NCT01294267|Other Pre-specified|Safety Outcomes|"Acute Kidney Injury Network stage 1 kidney injury (ie, an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%-200% from baseline.~A decline in neurocognitive function, as defined by a decrease in MMSE ≥2 points from the baseline score, after the procedure."|30 day||||Participants|||Count of Participants
2693581|NCT01294267|Secondary|Clinical Outcomes|Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month [30 days] follow up telephone interview to assess symptoms, side effects and medication use.|1 Month post ablation Follow up||||Participants|||Count of Participants
2693582|NCT01294267|Primary|Number of Participants With Procedural Success|Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System|Inpatient Admission||||Participants|||Count of Participants
2693583|NCT01294241|Secondary|Percentage of Wound Epithelialization at Day 14±1|The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 14±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.|Day 14±1|As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.|||Percentage of wound epithelialization|Wounds/wound halves|Full Range|Median
2693584|NCT01294241|Secondary|Percentage of Wound Epithelialization at Day 7±1|The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 7±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.|Day 7±1|As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.|||Percentage of wound epithelialization|Wounds/wound halves|Full Range|Median
2693585|NCT01294241|Primary|Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'|The primary end point was the progress of reepithelialization from baseline to either Day 14 ('recent wounds') or Day 28 ('chronic wounds') of the EB wound (half) treated with Oleogel-S10 and non-adhesive wound dressing (Mepilex®) intra-individually compared to the other wound (half) covered with non-adhesive wound dressing only (intra-individual comparison). Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28. They evaluated each series and decided whether 1 wound (half) reepithelialized faster than the other ('winner'), or whether there was no difference in reepithelialization.|14 days for 'recent wounds', 28 days for 'chronic wounds'|12 wounds in 10 participants (intra-individual comparison, 2 cycles of treatment in 2 participants) were evaluated by assessors that were blind to treatment. 'Undecided' wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|||Wounds|Wounds||Count of Units
2693586|NCT01294228|Primary|The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.|The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.|Prior to or within 72 hours.|Study participants who had both an adjudicated AKI diagnosis and an evaluable T=0 (study enrollment) blood collection and associated test results.|||Probability||95% Confidence Interval|Number
2693587|NCT01294163|Primary|Log-transformed Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set.|||ng/mL||95% Confidence Interval|Least Squares Mean
2693588|NCT01294163|Secondary|Presence of Absence of Adverse Events, Including Myocardial Infarction||7 days|||||||
2693596|NCT01294163|Primary|Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study.|||ng/mL||95% Confidence Interval|Least Squares Mean
2693597|NCT01294150|Secondary|Sexual Function|Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.|12 Months||||% of Subjects|||Number
2693598|NCT01294150|Primary|Mean UroLift Improvement in IPSS at 12 Months|The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.|12 months||||% IPSS Score Improvement||97.5% Confidence Interval|Number
2693599|NCT01294150|Primary|Comparison of IPSS for Efficacy|"The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.~The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).~SCORING:~0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|3 month||||IPSS total score||Standard Deviation|Mean
2693600|NCT01294150|Primary|Collection of Post-treatment Catheterization for Safety|The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.|Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days||||participants|||Number
2693601|NCT01294098|Secondary|Femur Fracture Healing|we will following patients to look at fracture healing post-operatively|first year||||weeks|||Number
2693602|NCT01294098|Primary|Post-operative Narcotic Use|We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use|within first 24 horus||||mg|||Number
2693603|NCT01294098|Primary|Post-operative Pain Scores|"We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores.~Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain.~0: No Hurt~Hurts a little bit~Hurts a little more~Hurts even more~Hurts a whole lot~Hurts worst"|with in the first 24 hours||||units on a scale||Full Range|Mean
2693604|NCT01294046|Secondary|Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia|Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693605|NCT01294046|Secondary|Implantation and Stimulation Related Adverse Events|As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693606|NCT01294046|Secondary|Average Per Subject Reduction in Migraine Days/Month|During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693607|NCT01294046|Secondary|Stimulation Related Adverse Events|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693608|NCT01294046|Secondary|Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline|The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693609|NCT01294046|Secondary|Headache Impact Test (HIT-6) Compared With Baseline|The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693610|NCT01294046|Secondary|Acute Migraine Medication Use|During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693611|NCT01294046|Secondary|Pain Free at 2 Hours Post Stimulation|As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
2693612|NCT01294046|Secondary|Migraine Free at 2 Hours|Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.|8.5 Months|No data were collected from this entire study, so no data were analyzed.||||||
2693613|NCT01294046|Primary|Migraine Relief at 2 Hours Post Stimulation|Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.|8.5 Months|No data were collected from this entire study, so no data were analyzed.||||||
2693614|NCT01293968|Secondary|The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed|4 days after the solution consumption|||||||
2693615|NCT01293968|Primary|Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution|four days after the start of the study|The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS|||scores in Visual Analogue Scale||95% Confidence Interval|Mean
2693616|NCT01293825|Secondary|Quality of Life Score as Measured by 12-item Short Form Health Survey|Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693617|NCT01293825|Secondary|Body Weight||Week 16||||lbs||Standard Deviation|Mean
2693618|NCT01293825|Secondary|Young Mania Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693619|NCT01293825|Secondary|Montgomery Asberg Depression Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693620|NCT01293825|Secondary|Social and Occupational Functioning Scale|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693621|NCT01293825|Secondary|Global Psychopathology Score as Measured by Clinical Global Impressions|Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693622|NCT01293825|Secondary|Attitude Toward Medication Score as Measured by the Drug Attitude Inventory|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693623|NCT01293825|Secondary|Treatment Adherence Score as Measured by the Morisky Rating Scale|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
2693624|NCT01293825|Primary|Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)|Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.|Week 16||||Percentage of doses||Standard Deviation|Mean
2693625|NCT01293695|Primary|Hot Flash Related Daily Interference Scale (HFRDIS)|This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.|6 Weeks and 12 Weeks||||units on a scale||Standard Deviation|Mean
2693626|NCT01293695|Secondary|Pittsburg Sleep Quality Index (PSQI)|The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.|6 Weeks and 12 Weeks||||units on a scale||Standard Deviation|Mean
2693627|NCT01293695|Secondary|Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture|As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.|6 Weeks and 12 Weeks|Analysis was conducted on all available physiological data to determine hot flash frequency. Data was missing for 29 participants in the hypnosis group and 17 participants in the structured attention group.|||Micro Siemens||Standard Deviation|Mean
2693628|NCT01293695|Primary|Hot Flash Score|"Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).~Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).~The values presented represent the average of daily hot flash scores."|6 Weeks and 12 Weeks||||units on a scale||Standard Deviation|Mean
2693629|NCT01293695|Primary|Hot Flash Frequency|The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).|6 Weeks and 12 Weeks||||hot flashes per week||Standard Deviation|Mean
2693632|NCT01293539|Primary|Number of Patients Who Complete Therapy Without the Need for Additional Treatment Including Systemic Chemotherapy, External Beam Radiation, or Enucleation.|The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.|Within the first six months after the initial treatment.||||Participants|||Count of Participants
2693633|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||logMAR|Participants|Standard Deviation|Mean
2693634|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||logMAR|Participants|Standard Deviation|Mean
2693635|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale|Participants|Standard Deviation|Mean
2693636|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale|Participants|Standard Deviation|Mean
2693637|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693638|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693639|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693640|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693641|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693642|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693643|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693644|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2693645|NCT01293123|Secondary|Measure of Quality of Life|Change in self-report quality of life over 180 days|180 days|Insufficient enrollment for data analysis||||||
2693646|NCT01293123|Secondary|Measure of Sleep|Change in self-reported sleep performance over 180 days.|180 days|Insufficient enrollment for data analysis||||||
2693647|NCT01293123|Secondary|Measure of Mood|Change in mood over 180 days|180 days|Insufficient enrollment for data analysis||||||
2693652|NCT01293032|Primary|The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment|The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.|Up to 2 years|Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis.|||proportion of participants||95% Confidence Interval|Number
2693653|NCT01293006|Secondary|Mean Arterial SaO2 During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant on mean oxygen saturation (SaO2) during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
2693654|NCT01293006|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment. Sleep stages were determined by polysomnography.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
2693655|NCT01293006|Secondary|Mean Apnea/Hypopnea Index (AHI)|Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Events per hour||95% Confidence Interval|Least Squares Mean
2693656|NCT01293006|Secondary|Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%|Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Percentage of Total Sleep Time||95% Confidence Interval|Least Squares Mean
2693657|NCT01293006|Primary|Number of Participants Discontinued From Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 15 days|All participants were included in the Safety Population.|||participants|||Number
2693658|NCT01293006|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.|||participants|||Number
2693659|NCT01293006|Primary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
2693660|NCT01292928|Other Pre-specified|Quality of Life|Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects|||units on a scale||Standard Deviation|Mean
2693661|NCT01292928|Other Pre-specified|Walking Improvement (Distance) Assessed by 6 Minute Hall Walk|Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects|||meters||Standard Deviation|Mean
2693662|NCT01292928|Other Pre-specified|Walking Improvement (Time) Assessed by 6 Minute Hall Walk|Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects|||minutes||Standard Deviation|Mean
2693689|NCT01292629|Primary|Visual Acuity|BEST Spectacle-Correction (ETDRS) Distance Visual Acuity|4 to 6 months|125 subjects enrolled in the study, 121 were examined at the Form 4 and the remaining four (3.2%) subjects missed the Form 4 visit but were examined later. 121 subjects were evaluated for primary and secondary effectiveness and safety outcomes.|||subjects|||Number
2693663|NCT01292928|Other Pre-specified|Walking Improvement Assessed by the Walking Impairment Questionnaire|The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects|||units on a scale||Standard Deviation|Mean
2693664|NCT01292928|Other Pre-specified|Rate of Hemodynamic Improvement|"The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.~Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.~Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR."|12 months|278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)|||percentage of limbs|limbs||Number
2693665|NCT01292928|Other Pre-specified|Rutherford Classification|"Class 0: Asymptomatic~Class 1: Mild claudication~Class 2: Moderate claudication~Class 3: Severe claudication~Class 4: Ischemic rest pain~Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema~Class 6: Major tissue loss - extending above metatarsal (MT) level~Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.~Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.~Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure"|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects|||percentage of participants|||Number
2693666|NCT01292928|Other Pre-specified|Stent Fracture Rate|"Vascular InterVentional Advances (VIVA) definitions:~Grade 0: No strut fractures~Grade I: single strut fracture~Grade II: multiple strut fractures~Grade III: stent fracture(s) with preserved alignment of the components~Grade IV: stent fracture(s) with mal-alignment of the components~Grade V: stent fracture(s) in a trans-axial spiral configuration"|12 months|From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 250 subjects|||percentage of stents|stents||Number
2693667|NCT01292928|Other Pre-specified|Assisted Primary Patency|Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 256 subjects|||percentage of lesions||95% Confidence Interval|Number
2693668|NCT01292928|Other Pre-specified|Primary Patency|Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 268 subjects/lesions|||percentage of lesions|Lesions|95% Confidence Interval|Number
2693669|NCT01292928|Other Pre-specified|Technical and Procedural Success|"Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%~Procedural success: technical success with no MAEs within 24 hours of the procedure"|Up to 24 hours after the procedure||||percentage of participants||95% Confidence Interval|Number
2693670|NCT01292928|Secondary|Secondary Safety Endpoint and Components|The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month|1 month|From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects|||percentage of participants||95% Confidence Interval|Number
2693671|NCT01292928|Primary|Co-Primary Efficacy Endpoints|"The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.~The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).~The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm)."|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 268 subjects|||percentage of participants||95% Confidence Interval|Number
2693672|NCT01292928|Primary|Primary Safety Endpoint and Components|The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months|1 month for death, 12 months for target limb major amputation , and target lesion revascularization|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.|||percentage of participants||95% Confidence Interval|Number
2693673|NCT01292876|Secondary|Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative|The secondary objective is to examine the cellular properties of the biopsy tissue material in each subject for future correlation with clinical outcomes. Seven biopsy samples were collected and stained with Hematoxylin and eosin (H&E) and Masson's trichrome stain. Tissue was stained with antibodies against the progenitor cell markers CD146 and NG2 to show evidence of progenitor cell migration into the remodeling injury site.|Approximately 6 months post-operative|Demonstrated remodeling response; discrepancy from from those completed in the study (12 of 13) is result of 1 subject not undergoing pathological examination.|||percentage of participants remodeling|||Number
2693674|NCT01292876|Primary|Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative|The physical therapy program was designed to promote activation of the dorsiflexor muscles on the operated side, through manual feedback during volitional contractions.|approximately 24 weeks post-operative||||% change||95% Confidence Interval|Mean
2693790|NCT01292005|Primary|Change in C-Reactive Protein (CRP)|C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.|baseline, Day 1, Day 3||||mg/L||Full Range|Median
2693675|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.|Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period."|||participants|||Number
2693676|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Treatment Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.|Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.|||participants|||Number
2693677|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period|The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period."|||percentage of participants|||Number
2693678|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.|||percentage of participants|||Number
2693679|NCT01292837|Secondary|The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period|"The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - E)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with combined Baseline Period and post-Baseline generalized tonic-clonic seizure counts. 12 of the 13 subjects in the FAS were included in the analysis excluding 1 subject discontinued before the Evaluation Period.|||percent change||Standard Deviation|Mean
2693680|NCT01292837|Primary|The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)|"The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - T)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.|||percent change||Standard Deviation|Mean
2693681|NCT01292798|Secondary|Qualitative Assessment of Diabetic Macular Edema (DME)|To compare the percentage of subjects with compete or partial/no resolution of diabetic macular edema in response to the ranibizumab 0.5 and 2.0 mg doses.|Baeline and 6 months|At 6 months, 18 out of the 43 subjects (42%) showed complete resolution of DME. 25 out of the 43 subjects (58%) showed partial or no resolution of DME at 6 months.|||percentage of participants|||Number
2693682|NCT01292798|Secondary|Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline|To determine the mean change in central 1-mm subfield thickness as measured by spectral-domain OCT from baseline to 6 months .|baseline and 6 months||||microns||Standard Deviation|Mean
2693683|NCT01292798|Primary|Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline|To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months.|baseline and 6 months||||letters||Standard Deviation|Mean
2693684|NCT01292746|Primary|Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area|Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.|Baseline and 13 Weeks||||hairs/cm2||Standard Deviation|Mean
2693685|NCT01292642|Secondary|Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks|The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction.|10 weeks||||Scores on a scale||Standard Deviation|Mean
2693686|NCT01292642|Primary|Cannabis Use|cannabis inhalations per day|Baseline and 10 weeks||||cannabis inhalations/day||Standard Deviation|Mean
2693687|NCT01292642|Primary|Cigarette Use|cigarettes per day|Baseline and 10 weeks||||cigarettes/day||Standard Deviation|Mean
2693690|NCT01292603|Secondary|Part 2: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n= number of participants analyzed at the specified visit.|||percentage of participants|||Number
2693691|NCT01292603|Secondary|Part 2: Total CD19+ B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n = number of participants analyzed at the specified visit.|||cells/μL||Full Range|Median
2693692|NCT01292603|Secondary|Part 1: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.|||percentage of participants|||Number
2693693|NCT01292603|Secondary|Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.|||cells per microliter (cells/μL)||Full Range|Median
2693694|NCT01292603|Secondary|Part 2: Percentage of Participants With Anti-Rituximab Antibodies|In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.|Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.|SAP; n = number of participants analyzed for the specific parameter.|||percentage of participants|||Number
2693695|NCT01292603|Secondary|Part 1: Percentage of Participants With Anti-Rituximab Antibodies|Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.|Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose|Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.|||percentage of participants|||Number
2693696|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question: Which formulation of rituximab (SC or IV) do you think is more convenient? with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively."|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis.|||percentage of participants in the survey|||Number
2693697|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question:  If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones). The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively."|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis.|||percentage of participants in the survey|||Number
2693698|NCT01292603|Secondary|Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration|In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC|Days 4 to 5 in Cycle 6|All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.|||percentage of participants or nurses|||Number
2693699|NCT01292603|Secondary|Part 2: Terminal Half-Life of Rituximab at Cycle 6|The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
2693700|NCT01292603|Secondary|Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6|Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
2693701|NCT01292603|Secondary|Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6|Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2693722|NCT01292304|Secondary|Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)|This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.|12 weeks of study drug||||Days||Full Range|Median
2693702|NCT01292603|Secondary|Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6|AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||μg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2693703|NCT01292603|Primary|Part 2: Rituximab C Trough Levels at Cycle 5|Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.|+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration|Only participants who entered Part 2 of the study and had pharmacokinetic (PK) data available were included in the analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2693704|NCT01292603|Primary|Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab|Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.|Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose|Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.|||mg|||Number
2693705|NCT01292538|Primary|Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs|Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.|2 weeks||||inches||Standard Deviation|Mean
2693706|NCT01292486|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands.|7 days|Data to calculate the percent of product WBCs that were segmented granulocytes or bands was available for 38 MNC collections on 25 of the 26 per protocol patients.|||percentage of product WBCs|Participants|Full Range|Median
2693707|NCT01292486|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.|7 days|Data was available from 38 MNC collections from 25 of the 26 per protocol patients.|||hematocrit %|Participants|Full Range|Median
2693708|NCT01292486|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|up to 7 days|Data to calculate platelet collection efficiency was available for 38 MNC collections on 24 of the 26 per protocol patients.|||% of processed platelets collected|Participants|Full Range|Median
2693709|NCT01292486|Secondary|Mononuclear Cel (MNC) Collection Efficiency|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.~Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%."|up to 7 days|Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients.|||% of processed MNCs that were collected|Participants|Full Range|Median
2693710|NCT01292486|Secondary|CD34+ Cell Collection Efficiency.|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.~CD34+ is a cell surface marker found on pluripotent hematopoeitic stem cells."|up to 7 days|Data to calculate CD34+ cell collection efficiency was available for 39 collections on 24 of 26 per protocol patients.|||% of processed CD34+ cells collected|Participants|Full Range|Median
2693711|NCT01292486|Secondary|Days Until Platelet Recovery|The time to platelet recovery is defined as the day following stem-cell transplant (Day 0) on which the platelet count exceeds 20,000/μL, for the first of three consecutive measurements obtained on different days, without platelet transfusion support within the preceding 7 days.|up to 28 days following transplant|All per protocol patients for whom platelet recovery data was available.|||days||Full Range|Median
2693712|NCT01292486|Primary|Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.|"Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease.~As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > |2|, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery."|up to 28 days following transplant|Twenty-six patients were evaluable per protocol.|||Days||Full Range|Median
2693713|NCT01292473|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.|||Percentage of days||Standard Deviation|Mean
2693714|NCT01292473|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12|The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug and who had a DLQI score at Week 12.|||Units on a scale||Standard Deviation|Mean
2693715|NCT01292473|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
2693716|NCT01292473|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.~The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline."|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Percentage of participants|||Number
2693717|NCT01292473|Secondary|Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Percentage of participants|||Number
2693718|NCT01292473|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.~The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved."|by Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Weeks||95% Confidence Interval|Median
2693719|NCT01292473|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
2693720|NCT01292473|Secondary|Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
2693721|NCT01292473|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
2693726|NCT01292304|Primary|Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)|Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing|Week 12||||participants|||Number
2693727|NCT01292265|Secondary|Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
2693728|NCT01292265|Secondary|Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
2693729|NCT01292265|Secondary|Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
2693730|NCT01292265|Primary|Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
2693731|NCT01292239|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|"The table below shows the median (range) AUC24h values for TMC435 for all participants in the TMC435 treatment group who received TMC435 for up to 12 weeks. The time frame of Overall (up to Week 12) represents the median exposure estimate using all available data for each participant in the study."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng.h/mL||Full Range|Median
2693732|NCT01292239|Secondary|Plasma Concentrations of TMC435|"The table below shows median (range) predose plasma concentration (C0h) values and median (range) maximum plasma concentration (Cmax) values for TMC435 for all participants in the TMC435 treatment group. The time frame of Overall (up to Week 12) represents the median exposure estimate using all available data for each participant in the study."|Overall (ie, Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
2693733|NCT01292239|Secondary|The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in the TMC435 treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with pegIFN alpha 2a and RBV at Week 24. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group continued treatment with PegIFN alpha 2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693734|NCT01292239|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline (Day 1) who achieved normal ALT levels at the EOT (up to Week 24 or 48). At Baseline, 61/123 participants in the TMC435 treatment group and 25/60 participants in the Placebo treatment group had abnormal ALT levels. At the EOT, 47 (77.0%) participants in the TMC435 treatment group and 18 (72.0%) participants in the Placebo treatment group had ALT levels that returned to normal (or normalization of ALT levels defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT.).|Baseline (Day 1) to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2693735|NCT01292239|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) at the End of Treatment (EOT) (up to Week 24 or 48) and detectable HCV RNA during follow-up or detectable plasma levels of HCV RNA at the time points of sustained virologic response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable plasma levels of HCV RNA at the EOT and with at least one follow-up HCV RNA. measurement.|Up to Week 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2693736|NCT01292239|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of > 1 log10 IU/mL in plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA)l from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period (up to the end of treatment [EOT]).|Up to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2693737|NCT01292239|Secondary|The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable plasma levels of HCV RNA <1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at the EOT (up to Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693738|NCT01292239|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in plasma levels of HCV RNA at each time point during treatment and post-treatment follow-up (FU).|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693739|NCT01292239|Secondary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT, defined as up to Week 24 or 48) and at 24 weeks after the last dose of treatment (up to Week 48 or 72).|EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693740|NCT01292239|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693741|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples|||correlation coefficient|Participants||Number
2693742|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples|||correlation coefficient|Participants||Number
2693743|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples|||correlation coefficient|Participants||Number
2693744|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population|||correlation coefficient|Participants||Number
2693745|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population|||correlation coefficient|Participants||Number
2693746|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
2693747|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
2693748|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
2693749|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
2693750|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
2693751|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed|||correlation coefficient|Participants||Number
2693752|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
2693753|NCT01292226|Secondary|Percentage of Participants With Hematologic Toxicity|Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate).|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population|||percentage of participants|||Number
2693754|NCT01292226|Secondary|Percentage of Participants With Gastrointestinal Toxicities|Gastrointestinal adverse events (AEs) according to WHO worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)|Safety population|||percentage of participants|||Number
2693755|NCT01292226|Secondary|Percentage of Participants With Infection|Infections were graded according to the World Health Organization (WHO) worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population: all enrolled participants|||percentage of participants|||Number
2693756|NCT01292226|Secondary|Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint|TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
2693757|NCT01292226|Secondary|Interleukin 8 (IL-8) Expression by Visit and Timepoint|IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
2693758|NCT01292226|Secondary|IMPDH Expression II by Visit and Timepoint|IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
2693759|NCT01292226|Secondary|IMPDH Expression I by Visit and Timepoint|IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell).|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
2693760|NCT01292226|Secondary|Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint|"IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is U. One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH)."|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||enzyme units|Participants|Standard Deviation|Mean
2693761|NCT01292226|Secondary|MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit|The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2).|Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mcg*hr/mL||Standard Deviation|Mean
2693762|NCT01292226|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)|BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population|||percentage of participants|||Number
2693763|NCT01292226|Secondary|Free MPA (mcg/mL) by Visit|Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins.|Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits|ITT population; n=number of samples analyzed.|||mcg/mL|Participants|Standard Deviation|Mean
2693764|NCT01292226|Secondary|Total Mycophenolate Acid (MPA) by Visit and Timepoint|Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins.|Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits|ITT population; n=number of samples analyzed.|||mcg/mL|Participants|Standard Deviation|Mean
2693765|NCT01292226|Secondary|Percentage of Participants Surviving||Day 1, Weeks 2, 4, 12, 24, and 28|ITT population|||percentage of participants|||Number
2693766|NCT01292226|Secondary|Percentage of Participants With Graft Loss|An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population|||percentage of participants|||Number
2693857|NCT01290822|Secondary|Interventricular Synchrony||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
2693767|NCT01292226|Primary|Time to Rejection|The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population; only participants with acute or biopsy-proven rejection were included in the analysis.|||days||Standard Deviation|Mean
2693768|NCT01292226|Primary|Percentage of Participants With Acute Rejection|Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.|Day 1, Weeks 2, 4, 12, 24, and 28|Intent-to-treat (ITT) population: all eligible participants who had at least baseline (BL) and 1 assessment of pharmacokinetics (PK) and pharmacodynamics (PD). Acute rejection was analyzed in any participant with an increase in serum creatinine of 25%.|||percentage of participants|||Number
2693769|NCT01292187|Secondary|Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.||Baseline, Week 54|MITT population|||percent change||95% Confidence Interval|Least Squares Mean
2693770|NCT01292187|Primary|Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.||Baseline, Week 54|MITT population|||percent change||95% Confidence Interval|Least Squares Mean
2693771|NCT01292135|Secondary|Progression Free Survival Rate at 12 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.||||Percentage of Participants||95% Confidence Interval|Number
2693772|NCT01292135|Secondary|Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline||From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.|No participants in the FCR group had neutropenia, anemia or thrombocytopenia at baseline.|||Percentage of Participants||95% Confidence Interval|Number
2693773|NCT01292135|Secondary|Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.|From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants||95% Confidence Interval|Number
2693774|NCT01292135|Secondary|Overall Incidence of Serious Adverse Events (SAEs)||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants|||Number
2693775|NCT01292135|Secondary|Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants|||Number
2693776|NCT01292135|Secondary|Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants|||Number
2693777|NCT01292135|Primary|Incidence of Prolonged Hematologic Toxicity Started in Cycle 1||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|The FCR arm was discontinued due to very limited use of this chemo regimen in this setting, statistical analysis were limited due to the small numbers of subjects in this treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
2693778|NCT01292070|Primary|Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema|Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.|up to 3 hours after the last injection of GFD|The experimental protein (human Fcgamma1-Fel d1 fusion protein (GFD)) and the control protein (standardized cat hair allergenic extract (CAT)) elicited comparable reactivity in the first four participants dosed; thus, the trial was discontinued for futility and the primary endpoint was not evaluated||||||
2693779|NCT01292057|Primary|Total Number of Drinks Consumed in Bar Lab|"This measure refers to a bar lab paradigm in which individuals received an initial priming drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8."|2 hours during the bar lab paradigm||||bar lab drinks||Standard Error|Mean
2693780|NCT01292057|Primary|Total Number of Drinks Per Day During Natural (Usual Environment) Conditions|"Natural alcohol consumption period -- drinks per day consumed during the 6-day observation period"|6-day observation period||||standard drinks||Standard Error|Mean
2693781|NCT01292005|Secondary|Number of Subjects Who Needed an Intensive Care Unit Stay||30 days, or until dismissal, whichever came first||||participants|||Number
2693782|NCT01292005|Secondary|Length of Intensive Care Unit (ICU) Stay||30 days or until dismissal date, whichever occurs earlier||||Days||Full Range|Median
2693783|NCT01292005|Secondary|Length of Hospital Stay||30 days or until dismissal date, whichever occurs earlier||||days||Full Range|Median
2693784|NCT01292005|Secondary|Number of Patients With Lengthy Hospital Stays|"Lengthy was defined as either greater than 4 days or greater than 10 days."|30 days or until dismissal date, whichever occurs earlier||||participants|||Number
2693785|NCT01292005|Secondary|Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization||1 week or until dismissal date whichever occurs earlier||||participants|||Number
2693786|NCT01292005|Secondary|Number Of Subjects With New Onset Organ Failure During Hospitalization||1 week or until dismissal date whichever occurs earlier.||||participants|||Number
2693787|NCT01292005|Primary|Changes in Interleukin (IL) IL-8|Normal value range for IL-8 = 0 - 5 pg/ml.|baseline, Day 1, Day 3||||pg/ml||Full Range|Median
2693791|NCT01291836|Primary|Evaluating the Efficacy of the Triage NGAL Test as an Aid in Predicting Poorer Outcomes in Patients Admitted to the Hospital With Admitted With Symptoms of Acute Heart Failure.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|~30 days|Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.|||Probability classifying AKI from non-AKI||95% Confidence Interval|Number
2693792|NCT01291836|Primary|Evaluating the Efficacy of the Triage NGAL Test as an Aid to Diagnosis of Acute Kidney Injury (AKI) in Patients Admitted to the Hospital With Symptoms of Acute Heart Failure.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|First week of hospitalization.|Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.|||Probability classifying AKI from non-AKI||95% Confidence Interval|Number
2693793|NCT01291784|Secondary|JAK2V617F Allele Burden|Investigate exploratory markers, hematopoietic cells, for their ability to predict responsiveness to treatment with GC1008. Analysis of percentage of mutant alleles in hematopoietic stem cells.|6 months||||percentage of mutant alleles|||Number
2693794|NCT01291784|Secondary|Peripheral Blood CD34+|Investigate exploratory markers for their ability to predict responsiveness to treatment with GC1008.|6 months||||percentage of hematopoietic stem cells|||Number
2693795|NCT01291784|Secondary|European Consensus Fibrosis Grade|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by European consensus grading system.~This scheme consists of a qualitative (reticulin or collagen) and quantitative evaluation of bone marrow fibrosis and distinguishes four increasing categories, ranging from MF-0, which corresponds to normal bone marrow, to MF-3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis."|6 months||||units on a scale|||Number
2693796|NCT01291784|Secondary|Bauermeister Scale|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by Bauermeister scale.~Bauermeister scale: 0, no demonstrable reticulin fibers; 1, occasional fine individual fibers and foci of a fine-fiber network; 2, fine fiber network throughout most of the section, but no coarse fibers; 3, diffuse fiber network with scattered thick coarse fibers, but no mature collagen; and 4, diffuse, often coarse fiber network with areas of collagen."|6 months||||units on a scale|||Number
2693797|NCT01291784|Primary|Safety and Tolerability|"To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).~A total of 9 AEs determined by the investigator to be at least possibly related to GC1008 occurred during the study."|28 days||||events|||Number
2693798|NCT01291498|Secondary|Voice Morbidity|Voice Handicap Index. 30 questions rated on a five point scale from 'never' to 'always' and an overall score from 1 'normal' to 10 'severely impaired'|Up to one year post-treatment||||units on a scale|||Number
2693799|NCT01291498|Secondary|Eucalcaemia|Ca in plasma|Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.|Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.|||mmol/L|||Number
2693800|NCT01291498|Primary|Eucalcaemia|Calcium in the blood is measured from venepuncture|12 months post-treatment|The primary endpoint was not analysed because only one subject was entered and this subject was withdrawn from the study before 12 months after treatment.||||||
2693801|NCT01291277|Primary|Proportion of Patients With Eradication of Esophageal Varices||At 4 weeks||||Participants|||Count of Participants
2693802|NCT01291264|Primary|Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.|This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.|1 day - (At clinic visit)|per protocol|||Positive test result|||Number
2693803|NCT01291225|Secondary|Playground and Farm Safety Knowledge, Attitudes and Practices Composite Scores|The investigators hypothesize that the improvement in the playground safety Knowledge, Attitudes, and Practices (KAP) survey composite scores and farm audits from the baseline in year 1 to the follow-up in year 3 will be significantly greater for parents residing in Ross County than for parents in the non-intervention counties (Morrow and Pickaway).The playground safety KAP survey consisted of 7 items and individuals could receive a summed score of 0-7, with a score of 7 indicating mastery of the material.|Year 1 baseline to Year 3 follow-up||||composite score||Standard Deviation|Mean
2693804|NCT01291225|Primary|Change in Playground Hazards|The investigators hypothesize that the decrease in the number of identified playground hazards (comparing each playground to itself from the year 1 baseline survey to the year 3 follow-up survey utilizing a playground hazards checklist) will be significantly greater for the intervention playgrounds compared with non-intervention playgrounds in Circleville, Pickaway Co. The percentage increase in the number of playgrounds with adequate safety surfacing will be used as a proxy for playground hazardousness.|Year 1 baseline to year 3 follow-up||||% increase playgrounds w/surfacing|||Number
2693805|NCT01291173|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693806|NCT01291173|Secondary|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11|The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693807|NCT01291173|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 11|The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693808|NCT01291173|Secondary|Change From Baseline in Eating Inventory Score at Week 11|The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693809|NCT01291173|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11|The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693810|NCT01291173|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693811|NCT01291173|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11|The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2693812|NCT01291173|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)|||Percentage of participants|||Number
2693813|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)|||Percentage of participants|||Number
2693814|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)|||Percentage of participants|||Number
2693815|NCT01291173|Secondary|4-Week Binge Response|Subjects are free from binge episodes for 4 weeks.|Last 28 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Participants|||Number
2693816|NCT01291173|Secondary|1-Week Binge Response, Last Observation Carried Forward (LOCF)|The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.|Last 7 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Participants|||Number
2693817|NCT01291173|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks|The number of binge episodes per week as assessed by clinical interview based on subject diary.|Baseline and up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Binge Episodes||Standard Deviation|Mean
2693818|NCT01291173|Primary|Change From Baseline in Log Transformed Binge Days Per Week at Week 11|Binge day is defined as a day during which at least 1 binge episode occurs.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Log days||Standard Error|Least Squares Mean
2693819|NCT01291160|Primary|Number of 100% Wound Closure||before or at week 12|Analyzed the per-protocol population|||percentage of patients|||Number
2693820|NCT01291108|Secondary|Change From Baseline in Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2693821|NCT01291108|Primary|Change From Baseline in Average Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2693822|NCT01291056|Primary|Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Physical symptoms were calculated to give the total score. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
2693823|NCT01291056|Primary|Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
2693824|NCT01291056|Primary|Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 Year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
2693825|NCT01291056|Primary|Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
2693826|NCT01291017|Secondary|Grade of Study Drug Toxicity|The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.|24 months||||Events|||Number
2693827|NCT01291017|Secondary|Plasma Levels|Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.|6 months|4 of the 16 samples were tested by protein immunoblot (Western blot), and due to the test not being sensitive enough to detect p16, phosphorylated RB or cyclin D1 protein bands in any of the samples, the decision was made not to purse this testing any further.|||Arbitrary Units|||Number
2693828|NCT01291017|Secondary|Progression-free Survival|Median progression-free survival.|12 months||||Weeks||Standard Error|Median
2693829|NCT01291017|Secondary|Overall Survival|Median overall survival|14 months||||weeks||Standard Error|Median
2693830|NCT01291017|Primary|Tumor Response by Direct RECIST Measurement|Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.|6 months||||participants|||Number
2693831|NCT01290978|Secondary|Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively|Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)|30 minutes|The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons|||units on a scale||Standard Deviation|Mean
2693832|NCT01290978|Primary|Drape Adhesion|The peel force to remove the sample|30 minutes|Data analysis per protocol|||grams-force||95% Confidence Interval|Mean
2693833|NCT01290952|Secondary|Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one of more of the following:~Post-operative Atrial Fibrillation~IAPB (Intra-Aortic Balloon Pump) insertion and low cardiac output syndrome~Ventilation > 24h~Sternal wound infection or dehiscence"|30 days||||participants|||Number
2693834|NCT01290952|Primary|Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one or more of the following:~Operative Mortality~Myocardial Infarction~Postoperative neurological complications~Renal failure~ARDS (Acute Respiratory Distress Syndrome)~Bleeding"|30 days||||participants|||Number
2693835|NCT01290913|Secondary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour.|To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.|after 7-8 wks of desensitization||||participants|||Number
2693858|NCT01290822|Secondary|Peak RV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
2693836|NCT01290913|Primary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg)|To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.|First day of desensitization||||participants|||Number
2693837|NCT01290887|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|"Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.~Predose samples for the reslizumab-experienced participants came from the previous studies."|Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|Safety analysis set of participants with assessments at stated timeframes|||participants|||Number
2693838|NCT01290887|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits."|Weeks 24, 48, 72, 96, End of Study and Endpoint|Safety analysis set of participants with assessments at stated timeframes|||units on a scale||Standard Deviation|Mean
2693839|NCT01290887|Secondary|Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||units on a scale||Standard Deviation|Mean
2693840|NCT01290887|Secondary|Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.~."|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||units on a scale||Standard Deviation|Mean
2693841|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.~Significance criteria~Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)~Sitting heart rate-low: <50 and decrease of >=30 beats/min~Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)~Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)~Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)~Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)~Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)~Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)~Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)~Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)~Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)~Body temperature-low: <96.5° Fahrenheit (all ages)~Body temp-high: >100.5° F (all ages)"|Week 4 to Week 65|Safety analysis set, including participants who contributed to the analysis|||participants|||Number
2693842|NCT01290887|Secondary|Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~."|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||# puffs/day||Standard Deviation|Mean
2693843|NCT01290887|Secondary|Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|"The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second~."|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||liters/second||Standard Deviation|Mean
2693844|NCT01290887|Secondary|Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|"The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.~."|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||liters||Standard Deviation|Mean
2693845|NCT01290887|Secondary|Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||percentage of predicted FEV1||Standard Deviation|Mean
2693846|NCT01290887|Secondary|Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||liters||Standard Deviation|Mean
2693847|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.~Total bilirubin: >=34.2 μmol/L~White blood cells- low: <=3.0*10^9/L~White blood cells-high: >=20*10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Platelets: >=700*10^9/L~Absolute neutrophil count: <=1.0*10^9/L~Eosinophils: >=10~Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline"|Weeks 4, 8, 24 and 48|Safety analysis set, including participants who contributed to the analysis|||participants|||Number
2693848|NCT01290887|Primary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set|||participants|||Number
2693849|NCT01290874|Secondary|Change in Moderate Asthma Deterioration|Average Change in Moderate Asthma Deterioration Per Participant Over 12 Months. The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization.|from baseline to 12 months|Inadequate baseline data was collected so that the change in this variable could not be assessed.||||||
2693850|NCT01290874|Secondary|Change in Rescue Medication Use|Average Change in Rescue Medication Use Per Participant Over 12 Months. Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average, measured in puffs per day.|from baseline to 12 months|335 and 328 participants are missing data on rescue medication use in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
2693851|NCT01290874|Secondary|Change in Symptom-Free Day Questionnaire (SFDQ)|"Average Change in Symptom-Free Days Per Participant Over 12 Months Using the Symptom-Free Day Questionnaire (SFDQ).~The asthma symptom free day questionnaire (SFDQ) quantifies the number of days with neither daytime nor nighttime asthma symptoms, nor awakenings due to asthma symptoms."|from baseline to 12 months|The instrument used to collect data proved to be unreliable. The statistic for internal consistency demonstrated less than 30% internal consistency.||||||
2693852|NCT01290874|Secondary|Change in Asthma Symptom Utility Index (ASUI)|"Average Change in Asthma Symptom Utility Score Per Participant Over 12 Months Using the Asthma Symptom Utility Index (ASUI).~The ASUI is an 11-item preference-based outcome measure used in clinical trials and cost-effectiveness studies for asthma and is designed to assess the frequency and severity of cough, wheeze, dyspnea, nighttime awakenings, and side effects, weighted according to patient preferences.~4-point Likert scale to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe); scores range from 0 (worst possible symptoms) to 1 (no symptoms)."|from baseline to 12 months|257 and 265 participants are missing data on ASUI in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
2693853|NCT01290874|Secondary|Change in Asthma Quality of Life (AQLQ)|"Average Change in Asthma Quality of Life Score Per Participant Over 12 Months Using the Asthma Quality of Life Questionnaire (AQLQ).~The AQLQ has 32 questions in four domains (symptoms, activity limitation, emotional function, and environmental stimuli) and measures the functional problems that are troublesome to individuals with asthma. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items); 7-point Likert scale (7 = not impaired at all - 1 = severely impaired); scores range 1-7, with higher scores indicating better quality of life."|from baseline to 12 months|242 and 239 participants are missing data on AQLQ in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
2693854|NCT01290874|Secondary|Change in Asthma Control Questionnaire (ACQ)|"Average Change in Asthma Control Score Per Participant Over 12 Months Using the Asthma Control Questionnaire (ACQ).~The ACQ has six questions regarding symptoms, rescue short-acting β-agonist use and one about FEV1 % predicted. A 7-point scale (0 = no impairment, 6 = maximum impairment) is used for each question and the ACQ score is the mean value of these questions - hence between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to 12 months|334 and 326 participants are missing data on ACQ in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
2693855|NCT01290874|Secondary|Change in FEV1|Average change in lung function (FEV1) evaluated by spirometry per participant over 12 months|from baseline to 12 months|255 and 253 participants are missing data on change in FEV1 in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||liters||95% Confidence Interval|Mean
2693856|NCT01290874|Primary|Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year)|We summarize the survival experience using mean number of exacerbations/person-year and compare it using the log-rank test comparing kaplan-meier survival curve.|evaluated monthly (on average) via questionnaire for 12 months|intention-to-treat|||event per person-year||95% Confidence Interval|Mean
2693862|NCT01290822|Primary|Cardiac Output|The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.|13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
2693863|NCT01290796|Secondary|Percentage of Patients With Impression of Improvement With Procedure at 36 Months|"Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be satisfied if they felt that their urinary tract conditio0n was very much better or much better than how it felt before the surgery."|0-36 Months|Patients who completed 36 month evaulations|||percentage of participants|||Number
2693864|NCT01290796|Secondary|Percentage of Patients With Impression of Improvement With Procedure at 12 Months|"Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be satisfied if they felt that their urinary tract condition was very much better or much better than how it felt before the surgery."|0-12 Months|Patients who completed 12 month evaulations|||percentage of participants|||Number
2693865|NCT01290796|Secondary|Change in Incontinent Impact Questionnaire at 36 Months|Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 36-months post-surgery.|0-36 months||||units on a scale||Standard Deviation|Mean
2693866|NCT01290796|Secondary|Change in Incontinent Impact Questionnaire at 12 Months|Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 12-months post-surgery.|0-12 months||||units on a scale||Standard Deviation|Mean
2693867|NCT01290796|Secondary|Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|0-36 Months||||percentage of participants||95% Confidence Interval|Number
2693868|NCT01290796|Secondary|Change in Post-operative Pain|"Mean change in Overall McCarthy Surgical Pain Scale from Day 0 to Day 7. McCarthy Pain Scale is a 50 millimeter line with No Pain Sensation noted at the 0 mm mark and Most Intense Pain Imaginable noted at the 50 mm mark. Each day, subjects are asked to mark their level of pain somewhere along the line. Change in pain level is reported in millimeters."|0-7 days||||millimeters||Standard Deviation|Mean
2693869|NCT01290796|Secondary|Operative, Perioperative and Long-term Complications Through 36 Months|Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months|Day 15 through 36-months post procedure||||percentage of participants||95% Confidence Interval|Number
2693870|NCT01290796|Secondary|Operative, Perioperative and Long-Term Complications Perioperatively|Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively|1-15 days||||percentage of participants||95% Confidence Interval|Number
2693871|NCT01290796|Secondary|Operative, Perioperative and Long-Term Complications During Operative Procedure|Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure|1 day||||percentage of participants||95% Confidence Interval|Number
2693872|NCT01290796|Primary|Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|12-months post procedure||||percentage of participants||95% Confidence Interval|Number
2693873|NCT01290796|Primary|Percentage of Patients Free of Stress Urinary Incontinence|Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.|12-months post surgical procedure||||percentage of participants||95% Confidence Interval|Number
2693874|NCT01290757|Secondary|AUC0-∞ of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2693875|NCT01290757|Secondary|Cmax of Free Dabigatran in Plasma.|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2693876|NCT01290757|Secondary|AUC0-tz of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2693877|NCT01290757|Secondary|Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2693878|NCT01290757|Primary|Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2693879|NCT01290757|Primary|Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran|Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|This subject set, the pharmacokinetic set (PKS), includes all subjects of the treated set who provide at least one evaluable observation for at least one of the three PK endpoints of total dabigatran, which is obtained in a period without important protocol violations relevant to the evaluation of bioequivalence.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2693880|NCT01290731|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels (defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT). At baseline, 15/49 participants had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2693881|NCT01290731|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435|"The table below shows the median (range) AUC24h values for TMC435 for all participants who received TMC435 for up to 12 weeks. Overall is the median exposure estimate using all available data for each participant in the study. Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)."|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng.h/mL||Full Range|Median
2693882|NCT01290731|Secondary|Plasma Concentrations of TMC435|"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and the TMC435 maximum plasma concentration (Cmax) values for all participants who received TMC435 for up to 12 weeks. Overall is the median exposure estimate using all available data for each participant in the study.Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)."|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
2693883|NCT01290731|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at end of treatment (EOT) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of sustained virologic response (SVR) assessment . The incidence of viral relapse was calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2693884|NCT01290731|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in particpants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The table below shows that no viral breakthrough was noted in any participants during the treatment period of the study.|Day 1 until end of treatment (EOT [Week 24 or 48])|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2693885|NCT01290731|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (defined as less than 1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT [Week 24 or 48]).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693886|NCT01290731|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than or equal to 2 log10 IU/mL drop from baseline in plasma HCV RNA at each time point during treatment, at the end of treatment (Week 24 or 48), and post-treatment follow-up.|Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693887|NCT01290731|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|The table below shows the percentage of participants with a SVR24 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|Week 48 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693888|NCT01290731|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|The table below shows the percentage of participants with an SVR12 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) 12 weeks after the last dose of treatment (Week 36 or 60).|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2693889|NCT01290718|Secondary|Progression-Free Survival|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
2693890|NCT01290718|Secondary|Overall Survival|Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
2693891|NCT01290718|Secondary|Time to Disease Progression|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
2693892|NCT01290718|Primary|Percentage of Participants With Overall Response|The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
2693893|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2693894|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2693895|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2693896|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2693897|NCT01290679|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.|At protocol-specified time points at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||L/h||Standard Deviation|Mean
2694537|NCT01286272|Other Pre-specified|Immunohistochemical (IHC) Markers|The IHC markers will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data. No multiple testing adjustment will be applied because of the small sample size.|Up to 10 years|||||||
2693898|NCT01290679|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).|Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng/mL||Standard Deviation|Mean
2693899|NCT01290679|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.|At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng*h/mL||Standard Deviation|Mean
2693900|NCT01290679|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Weeks||95% Confidence Interval|Median
2693901|NCT01290679|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693902|NCT01290679|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||Standard Error|Mean
2693903|NCT01290679|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693904|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2693905|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2693906|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2693907|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2693908|NCT01290679|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693909|NCT01290679|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693910|NCT01290679|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693911|NCT01290679|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693912|NCT01290679|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693913|NCT01290679|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693914|NCT01290679|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693915|NCT01290679|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693916|NCT01290679|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Weeks 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693917|NCT01290679|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693918|NCT01290679|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693919|NCT01290679|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693920|NCT01290679|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693921|NCT01290679|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2693922|NCT01290679|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows changes from baseline in log10 HCV RNA.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2693923|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693988|NCT01290029|Secondary|Percent Change From Baseline in Albumin Corrected Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Standard Deviation|Mean
2693924|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693925|NCT01290679|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693926|NCT01290679|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2693927|NCT01290666|Secondary|Duration of Drainage Post Procedure||Follow up out to 12 months post procedure|||||||
2693928|NCT01290666|Primary|Fistula Closure||12 months post procedure||||participants|||Number
2693929|NCT01290640|Primary|In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|"Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation~The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative."|March 2013||||degrees|Implants|Standard Deviation|Mean
2693930|NCT01290640|Primary|In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|March 2013|Per protocol.|||mm|Implants|Standard Deviation|Mean
2693931|NCT01290627|Primary|Normalized Lateral Patella Contact Point Translation|"full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.|||ratio of patella height|Implants/Knees|Standard Deviation|Mean
2693932|NCT01290627|Primary|Normalized Medial Patella Contact Point Translation|"full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal"|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.|||ratio of patella height|Implants/Knees|Standard Deviation|Mean
2693933|NCT01290627|Primary|Patella Tilt With Respect to Femur|full extension to maximum flexion for participants with and without implants.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.|||degrees|Implants/Knees|Standard Deviation|Mean
2693934|NCT01290627|Primary|Patella Rotation With Respect to Femur|Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.|||degrees|Implants/Knees|Standard Deviation|Mean
2694960|NCT01283282|Primary|Endothelial Progenitor Cells (EPCs)|The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+|Week 12||||cells/µL||Standard Error|Mean
2693935|NCT01290627|Primary|Patella Flexion With Respect to Femur|Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.|||degrees|Implants/Knees|Standard Deviation|Mean
2693936|NCT01290614|Secondary|Number of Participants With PTH Measurement During the Study Period|The primary process outcome was measurement of PTH during the study period.|one year||||participants|||Number
2693937|NCT01290614|Primary|Systolic Blood Pressure (SBP)|Average SBP for those with a baseline BP > 130/80|one year|Baseline blood pressure >130/80 mmHg|||mmHg||Standard Deviation|Mean
2693938|NCT01290601|Other Pre-specified|Fever Clearance Time (FCT)|Measure of body temperature every 12 hours through day 7 was used to determine the time (to nearest 12 hours) from initiation of treatment until subjects temperature decreased to 37.2C and remained at or below that level for a minimum of 24 hours.|through day 7|Intent to treat population|||Hours||Standard Deviation|Mean
2693939|NCT01290601|Secondary|Parasite and Gametocyte Clearance Time (PCT and GCT)|Serial blood smears to detect the presence of P. vivax parasites and gametocytes, conducted every 12 hours up to and including day 7, until blood smear became negative were utilized to determine the time to clearance. PCT and GCT were considered cleared if 2 consecutive blood smears were negative.|up to day 7 after baseline smear|Intent to treat population|||Hours||Standard Deviation|Mean
2693940|NCT01290601|Secondary|Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)|To evaluate the safety and tolerability of the tafenoquine dosing regimens as defined by the most common AE's overall, occurring in >10% of subjects in either treatment group|90 Days||||AEs|||Number
2693941|NCT01290601|Secondary|Number of Subjects Without Relapse of P. Vivax|"Number of subjects without relapse of P. vivax at 2, 3 and 4 months~- Blood smears were obtained at Days 28, 60, 90 and 120 to confirm the continued absence of P. vivax parasitemia"|Day 28, Months 2, 3 and 4|Intent to treat population|||participants|||Number
2693942|NCT01290601|Primary|Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate|A subject will be considered a success (cure) if they have an Adequate Clinical Response (ACR). Tafenoquine was efficacious if the lower bound of the two-sided 90% confidence interval for the day 28 cure rate was not less than 85%|28 Days|Intent to treat population|||Participants|||Count of Participants
2693943|NCT01290536|Secondary|Radiographic Response|Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.|6 months after treatment|Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC.|||participants|||Number
2693944|NCT01290536|Primary|Number of Participants With Adverse Events|Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.|6 months||||participants|||Number
2693945|NCT01290523|Secondary|Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|"Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT:~up to 5 lesions at baseline and sum longest diameters (SLD).~Complete Response (CR), -Target Lesions: Disappearance of all target lesions.~-Non-target Lesions: disappearance of all non-target lesions and normalization of tumor marker level.~Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;~Stable Disease (SD) < %30 decrease in the sum of the longest diameter of target lesions.~Progressive Disease (PD) -Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir~non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy"|6 months||||Participants|||Count of Participants
2693946|NCT01290523|Primary|Number of Participants With Adverse Events|Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain|6 months||||participants|||Number
2693947|NCT01290484|Primary|Change in Volume of Lymphatic Malformation|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).|Baseline, 20 weeks||||percentage of volume change|||Number
2693948|NCT01290445|Secondary|Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)|Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age.|For 12 months after birth|Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. Here, ‘Number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||infants|||Number
2693949|NCT01290445|Secondary|Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes||At the time of birth|Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.|||infants|||Number
2693950|NCT01290445|Secondary|Number of Infants Born Preterm|Preterm birth was defined as birth before the gestational age of 37 weeks.|At the time of birth|Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.|||infants|||Number
2693951|NCT01290445|Secondary|Number of Infants Born Small for Gestational Age (SGA)|An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period.|At the time of birth|Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.|||infants|||Number
2693952|NCT01290445|Secondary|Number of Infants With Stillbirths|Stillbirth was defined as death at a gestational age of greater than or equal to (>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of >=28 weeks.|At the time of birth|Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.|||infants|||Number
2693953|NCT01290445|Primary|Number of Infants With Major Congenital Malformations|Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies.|For 12 months after birth|Analysis population included all live born infants in Denmark and Sweden from May 1, 2007 through December 31, 2012.|||infants|||Number
2693954|NCT01290341|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).~Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6|Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population.|||percentage of subjects|||Number
2693955|NCT01290341|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.~Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.|||percentage of subjects|||Number
2693956|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from baseline to Day 7 post end IV infusion|Only subjects with both a baseline and at least one post baseline value are included.|||mg||Standard Deviation|Mean
2693957|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from baseline to 24 hours post end IV infusion|Only subjects with both a baseline and at least one post baseline value are included.|||mg||Standard Deviation|Mean
2693958|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from baseline to 2 hours post end IV infusion|Only subjects with both a baseline and at least one post baseline value are included.|||mg||Standard Deviation|Mean
2693959|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from Baseline to Day 30|Only subjects with both a Baseline and at least one post-Baseline value are included.|||mg||Standard Deviation|Mean
2693960|NCT01290263|Primary|AMG 386 Dose Limiting Toxicity (DLT) [Cohort B Phase I]|A DLT is defined as an adverse event that (a) is related to the AMG 386 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 28 days of the study treatment, and (c) meets any of the following criteria: >= grade 3 thrombocytopenia; grade 4 neutropenia lasting > 7 days; grade 4 anemia lasting > 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5x10^9/L; clinically significant grade 3 non-hematologic toxicity despite maximal medical therapy lasting > 7 days, with the exception of grade 3 proteinuria which was considered a DLT if lasting > 14 days; grade 3 non-hematologic toxicity resulting in study drug discontinuation; grade 4 non-hematologic toxicity; >= grade 1 new CNS hemorrhage; >= grade 2 non-CNS hemorrhage.|Participants were assessed weekly while on study; the observation period for DLT evaluation was the first 28 days of study treatment.|All phase I Cohort B participants who completed 28 days on study treatment were evaluable. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.|||participants|||Number
2693961|NCT01290263|Secondary|Progression-Free Survival (PFS) [Cohort A and Cohort B]|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks. On Cohort A and B participants were followed for progression up to 36 days and 166 days.|All participants who received at least one dose of the study drug were evaluable for PFS.|||days||Full Range|Median
2693962|NCT01290263|Secondary|Overall Survival (OS) [Cohort A and Cohort B]|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 to 4 months from the end of treatment until death or lost to follow-up. On Cohort A and B participants were followed up to 554 days and 442 days.|All participants who received at least one dose of the study drug were followed for OS.|||days||Full Range|Median
2693963|NCT01290263|Secondary|Best Radiographic Response [Cohort A and Cohort B]|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD, stable non-enhancing lesions, and stable clinically.|Disease was assessed radiographically for response every 8 weeks.|All participants who received at least one dose of the study drug were evaluable for response.|||participants|||Number
2693989|NCT01290029|Secondary|Percent Change From Baseline in Total Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Standard Deviation|Mean
2694985|NCT01282866|Secondary|Level of Comfort Associated With Treatment||Each treatment|||||||
2693964|NCT01290263|Primary|AMG 386 Maximum Tolerated Dose (MTD) [Cohort B Phase I]|The MTD of weekly AMG 386 intravenously (IV) in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).|Participants were assessed weekly while on study; the observation period for MTD evaluation was the first 28 days of study treatment.|All phase I Cohort B participants who received at least one dose of the study drug were evaluable for MTD. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.|||mg/kg intravenously on days 1 and 15|||Number
2693965|NCT01290263|Primary|6-Month Progression-Free Survival (PFS6) [Cohort A and Cohort B]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: d|6 months||||proportion of participants||95% Confidence Interval|Number
2693966|NCT01290237|Secondary|AUC/MIC for Vancomycin in the Study Population|AUC/MIC using hypothetical MIC = 1 mg/L|within 48 hours after receiving the first dose of vancomycin|Number of measurements reflects the number of participants with blood samples available for testing|||AUC/MIC ratio||Standard Deviation|Mean
2693967|NCT01290237|Primary|Count of Participants With Vancomycin Trough Between 15 and 20|proportion of participants whose vancomycin trough was between 15 and 20 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group|8 hours after the first dose of vancomycin|Loading dose - trough at 8 hours was not collected for 11 participants: vancomycin was discontinued prior to second dose (7), participant changed their mind (1), other reason (3) Among participants allocated to conventional treatment, trough at 8 hours was not collected for 2: vancomycin discontinued prior to second dose (1), changed mind (1)|||Participants|||Count of Participants
2693968|NCT01290224|Secondary|Analgesic Use Over Time||On days 1-11 and for 10 weeks after therapy||||participants|||Number
2693969|NCT01290224|Secondary|Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Day 1 to Day 10||||participants|||Number
2693970|NCT01290224|Secondary|Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions|The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.|Day 1 and Week 10||||percentage of a scale||Standard Deviation|Mean
2693971|NCT01290224|Secondary|Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question|The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.|Week 1 and Week 10||||percentage of reduction in symptom||Standard Deviation|Mean
2693972|NCT01290224|Secondary|Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).|Day 1 and Day 10||||percentage of reduction in symptom||Standard Deviation|Mean
2693973|NCT01290224|Secondary|Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.|On days 1 and 2||||units on a scale||Standard Deviation|Mean
2693974|NCT01290224|Primary|Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire|CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.|On days 1 and 2||||Percentage of Participants|||Number
2693975|NCT01290094|Secondary|Correlation Coefficient of Participant's Profile With Compliance|Participant's profile included age, year since menopause, fracture history, and BMD at baseline.|Baseline up to Month 12|ITT population.|||correlation coefficient|||Number
2693976|NCT01290094|Secondary|Percentage of Participants Who Received All Planned Study Medication (Compliance)||Baseline up to Month 12|ITT population.|||percentage of participants|||Number
2693990|NCT01290029|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone||Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Inter-Quartile Range|Median
2694885|NCT01283555|Secondary|Number of Participants Reporting That the Instructions for Use Were Helpful|"For each applicator type, participants were asked if the instructions were helpful to you.~Response categories were yes and no."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2693977|NCT01290094|Secondary|Percent Change From Baseline in Total Hip T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.|||percent change||Standard Deviation|Mean
2693978|NCT01290094|Secondary|Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.|||percent change||Standard Deviation|Mean
2693979|NCT01290094|Primary|Percent Change From Baseline in Mean Hip BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2693980|NCT01290094|Primary|Percent Change From Baseline in Mean Hip Bone BMD at Month 12|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.|||percent change||Standard Deviation|Mean
2693981|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2693982|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|"Percent change was calculated as [(measure at time t minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.|||percent change||Standard Deviation|Mean
2693983|NCT01290068|Secondary|Median Total Spectacle Cost Prior to Any Reimbursement|Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.|Month 6 after second eye implantation|This analysis population includes all randomized and implanted participants. If total cost was missing for a spectacle independent subject, €0 was imputed. If total cost was missing for a spectacle-dependent subject, mean cost for all spectacle dependent-subjects in that group with a known total cost for the same type of spectacles was imputed.|||euros||Inter-Quartile Range|Median
2693984|NCT01290068|Primary|Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)|Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized.|||units on a scale||Standard Error|Least Squares Mean
2693985|NCT01290068|Primary|Proportion of Participants Reporting Spectacle Independence at All Distances|Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.|||percentage of participants|||Number
2693986|NCT01290068|Primary|Percentage of Participants Classified as Responders|Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.|||percentage of participants|||Number
2693987|NCT01290029|Secondary|Percent Change From Baseline in Ionized Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Standard Deviation|Mean
2694951|NCT01283321|Secondary|Median Blood Loss (mL) at 12 Hours After Surgery||From end of surgery to 12 hours after surgery||||ml||Inter-Quartile Range|Median
2693991|NCT01290029|Secondary|Terminal Half-life of Cinacalcet|The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.|Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.|||hours||Standard Deviation|Mean
2693992|NCT01290029|Secondary|Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set|||hours||Full Range|Median
2693993|NCT01290029|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set|||ng/mL||Standard Deviation|Mean
2693994|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.|||hr*ng/mL||Standard Deviation|Mean
2693995|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set|||hr*ng/mL||Standard Deviation|Mean
2693996|NCT01290029|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.|Day 1 to day 30|All participants who received at least 1 dose of cinacalcet.|||participants|||Number
2693997|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment|Fasting plasma glucose - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF|||mg/dL||Standard Error|Least Squares Mean
2693998|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment|Fasting plasma glucose - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF|||mg/dL||Standard Error|Least Squares Mean
2693999|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment|Waist circumference (cm) - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF|||cm||Standard Error|Least Squares Mean
2694000|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment|Waist circumference (cm) - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF|||cm||Standard Error|Least Squares Mean
2694001|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 76 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF|||kg||Standard Error|Least Squares Mean
2694002|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 52 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF|||kg||Standard Error|Least Squares Mean
2694003|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Diastolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF|||mmHg||Standard Error|Least Squares Mean
2694004|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Diastolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF|||mmHg||Standard Error|Least Squares Mean
2694005|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Systolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF|||mmHg||Standard Error|Least Squares Mean
2694006|NCT01289990|Primary|Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment|Change from baseline in HbA1c after 76 weeks|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF)|||% of HbA1c||Standard Deviation|Least Squares Mean
2694952|NCT01283321|Secondary|Volume (mL) of Platelets Transfused- During Surgery and up to 24 Hours After Surgery||Operative period up to 60 minutes and up to 24 hours after surgery||||ml||Inter-Quartile Range|Median
2694007|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Systolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)|||mmHg||Standard Error|Least Squares Mean
2694008|NCT01289990|Secondary|HbA1c (%) Changes From Baseline After 76 Weeks of Treatment|Change from baseline in HbA1c (%) after 76 weeks using MMRM approach|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)|||% of HbA1c||Standard Error|Least Squares Mean
2694009|NCT01289990|Primary|Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks|Baseline and 52 weeks|"Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.~(LOCF:Last observation carried forward)"|||% of HbA1c||Standard Error|Least Squares Mean
2694010|NCT01289912|Secondary|Comparison of Behavioral Problems Between Patients Taking RAD001 vs Placebo|"Scores for Baseline and 6 Month Timepoints are reported for the following secondary outcome measures:~Behavior Rating Inventory of Executive Function (BRIEF) (Measure of executive functions) T-scores are reported, with a mean of 50 and a standard deviation of 10. The range is 30-100 with higher scores indicating a worse outcome.~Behavioral Assessment System for Children (BASC) (Measure of emotional and behavioral problems) T-scores are reported (mean of 50, SD of 10). The range is 30-100 with higher scores indicating a worse outcome. Conversely, on the Adaptive Skills subscale of the BASC, lower scores indicate a poorer outcome.~Strengths and Difficulties Questionnaire (SDQ). Includes questions related to emotional symptoms, conduct problems, inattention/hyperactivity, peer relationship problems and prosocial behavior. Responses to these items are summed to comprise a Total Difficulties Score, which ranges from 0-40, with lower scores indicating a better outcome"|6 months||||units on a scale||Standard Deviation|Mean
2694011|NCT01289912|Secondary|Comparison of Academic Skills Between Patients Taking RAD001 vs. Placebo|Scores are reported for Baseline and 6 Month Timepoints. The secondary outcome measure was the Wide Range Achievement Test 4 (WRAT4), which was used to assess academic skills. The Reading and Math subtests were used. Standard scores are reported which have a mean of 100 and a standard deviation of 15 (range=40-160 where higher is better).|6 months||||units on a scale||Standard Deviation|Mean
2694012|NCT01289912|Secondary|Comparison of Autism Spectrum Disorders Features Between Patients Taking RAD001 vs. Placebo|Scores for the Baseline and 6 Month Timepoints are reported. The secondary outcome measure was the Social Responsiveness Scale (SRS). Standard scores are reported with a mean of 100 and standard deviation of 15. The range is 40-160 with higher scores indicating a better outcome.|6 months||||units on a scale (SRS)||Standard Deviation|Mean
2694013|NCT01289912|Secondary|Comparison of Sleep Disturbances Between Patients Taking RAD001 vs. Placebo|Comparison of sleep disturbances between patients taking RAD001 vs. placebo, measured by the Pediatric Sleep Questionnaire (PSQ) and sleep logs|6 months|Data was not collected reliably and therefore was not analyzed.||||||
2694014|NCT01289912|Secondary|Comparison of Absolute Change From Baseline in Frequency of Epileptiform Events Between Patients Taking RAD001 vs. Placebo|Comparison of absolute change from baseline in frequency of epileptiform events as recorded on seizure diaries between patients taking RAD001 vs. placebo|6 months|Data was not collected reliably and therefore was not analyzed.||||||
2694015|NCT01289912|Primary|Evaluation of the Efficacy of RAD001 on Neurocognition (Cambridge Neuropsychological Test Automated Battery) in Patients With TSC Compared With Placebo.|"Scores are reported for baseline and 6 month timepoints on the Cambridge Neuropsychological Test Automated Battery (CANTAB) subscales below. For all subscales, scores are reported as the mean difference between the study subjects and a normative population matched for age, gender and IQ (e.g., subject subscale score - mean of matched normative group = reported score). Higher scores represent a better outcome.~Spatial Span (SSP) (spatial memory span) Range: -3 to 3~Spatial Working Memory (working memory) Range: -3 to 3~Pattern Recognition Memory (PRM) (visual pattern recognition memory) Range: -3 to 3~Spatial Recognition Memory (SRM) (spatial recognition memory) Range: -4 to 4~Rapid Visual Information Processing (RVIP) (sustained attention) Range: -4 to 4~Stockings of Cambridge (SOC) (spatial planning) Range: -4 to 4~Intra-Extra Dimensional Set Shift (IDED) (cognitive flexibility) Range: -5 to 5~Reaction Time (processing speed) Range: -5 to 5"|6 months||||units on a scale||Standard Deviation|Mean
2694016|NCT01289912|Primary|Evaluation of the Efficacy of RAD001 on Neurocognition in Patients With TSC Compared With Placebo.|"Baseline and 6 month Timepoint scores are reported for the following primary outcome measures:~Peabody Picture Vocabulary Test 4 (PPVT-4; Receptive Language Measure). Scores reported as (mean, SD). Range=40-160, higher scores are better.~Expressive Vocabulary Test 2 (EVT-2; Expressive Language Measure). Scores reported as (mean, SD). Range=40-160, higher scores are better.~Wide Range Assessment of Memory and Learning 2 (WRAML2; Measure of Verbal Memory and Attention ). Scores reported as (mean, SD). Range=1-19, higher scores are better.~Vineland Adaptive Behavior Scales-II (VABS-II; Measure of Adaptive Behavior). Scores reported as (mean, SD). Range = 40-160, higher scores are better.~Purdue Pegboard Test (Measure of Fine Motor Speed and Coordination). Scores reported as (mean, SD). Range = 40-160, higher scores are better."|6 months||||units on a scale||Standard Deviation|Mean
2694017|NCT01289912|Primary|Evaluation of the Safety of RAD001 on Neurocognition in Patients With TSC Compared With Placebo in Patients With TSC.|Evaluation of the safety of RAD001 compared with placebo in patients with TSC focusing on NCI CTCAE Grade 3 and 4 adverse events, serious adverse events, and Grade 3 and 4 laboratory toxicities.|6 months||||Adverse Events|||Number
2694018|NCT01289847|Secondary|Therapeutic Efficacy|Number of days on therapeutic antibiotics|12 months||||days||Standard Deviation|Mean
2694019|NCT01289847|Secondary|Therapeutic Efficacy|Visits to physicians and/or emergency room|12 months||||visits||Standard Deviation|Mean
2694020|NCT01289847|Secondary|Therapeutic Efficacy|Number of days in hospital|12 months||||days||Standard Deviation|Mean
2694021|NCT01289847|Secondary|Therapeutic Efficacy|Number of days off school|12 months||||days||Standard Deviation|Mean
2702550|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 9 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 9 months||||number of occurences||Standard Deviation|Mean
2694022|NCT01289847|Secondary|Therapeutic Efficacy|Number and proportion of subjects who maintain trough IgG levels at least as high as the average of the 2 previous trough levels before the first Gammaplex infusion|From week 15 onwards|Seven subjects (28.0%) maintained trough IgG levels at all visits that were at least as high as the average of the two previous levels before the first infusion|||participants|||Number
2694023|NCT01289847|Primary|Adverse Events|Number of subjects with serious, acute, bacterial infections as a measure of efficacy|12 months|Intent to Treat (ITT)|||participants|||Number
2694024|NCT01289821|Secondary|Duration of Stable Disease (DOSD)|DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Per protocol set (PPS)|||Days||95% Confidence Interval|Median
2694025|NCT01289821|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Per protocol set (PPS)|||Days||95% Confidence Interval|Median
2694026|NCT01289821|Secondary|Disease Control (DC)|DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|PAS|||Proportion of participants|||Number
2694027|NCT01289821|Secondary|Progression-free Survival (PFS)|PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. PD = At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2694028|NCT01289821|Secondary|Overall Survival (OS)|OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Full analysis set (FAS, N=54) included all subjects who received treatment.|||Days||95% Confidence Interval|Median
2694029|NCT01289821|Primary|Objective Response (OR)|OR was defined as the best tumor response (confirmed complete response [CR] or partial response [PR]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions.|From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.|Primary analysis set (PAS, N=41) was a subset of the PPS and included the first 41 subjects, who were assigned to treatment|||Proportion of participants|||Number
2694030|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Time missed from work in hours because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work, question #2). The number of hours missed from work because of HCV was divided by the total number of hours supposed to work, and expressed as a percentage. An area under the curve (AUC) analysis compared the WPAI absenteeism scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms WPAI absenteeism scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI absenteeism scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|Analysis Population Description: The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2694039|NCT01289782|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||Standard Error|Mean
2694953|NCT01283321|Secondary|Volume (mL) of Fresh-frozen Plasma (FFP) Transfused-during Surgery and up to 24 Hours After Surgery||Operative period up to 60 minutes and up to 24 hours after surgery||||ml||Inter-Quartile Range|Median
2694031|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. Scores ranged from 0 (no effect on activities) to 10 (completely prevented me from doing my daily activities). An area under the curve (AUC) analysis compared the impairment in daily activity scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in impairment in daily activity scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in the impairment in daily activity scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2694032|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants during study visits throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). An area under the curve (AUC) analysis compared the overall WPAI Overall Work Productivity Scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the WPAI Overall Work Productivity Scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI Work Productivity Scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2694033|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment began and throughout treatment and follow-up to rate the severity and impact of fatigue they experienced in the preceding 2 weeks on their daily lives. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst possible fatigue]. An area under the curve (AUC) analysis compared the overall severity of fatigue in each treatment group from baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the amount of fatigue participants experienced throughout the study resulting in equal AUC from baseline to Week 72 (AUC72) for FSS total scores. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
2694034|NCT01289782|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) values for the CL of TMC435.To calculate the mean CL for all participants in the study, CL values were first derived for each participant at each visit and then a median CL value calculated across visits for each participant. The median CL value for each participant was used to calculate the mean CL for all participants in the study.|Across Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||L/h||Standard Deviation|Mean
2694035|NCT01289782|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) values for the C0h of TMC435.To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then a median C0H value calculated across visits for each participant. The median COh value for each participant across all visits was used to calculate the mean C0h for the study.|Before administration of TMC435 at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng/mL||Standard Deviation|Mean
2694036|NCT01289782|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 for all participants. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then a median AUC value calcuated across all visits for each participant. The median AUC value across all visits for each participant was used to calculate the mean AUC 24 hr all participants in the study.|Fom the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng*h/mL||Standard Deviation|Mean
2694037|NCT01289782|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Weeks||95% Confidence Interval|Median
2694038|NCT01289782|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 158 of 264 participants in the TMC435 treatment group and 89 of 130 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication).|||Percentage of participants|||Number
2694650|NCT01285427|Primary|SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694040|NCT01289782|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694041|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2694042|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2694043|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2694044|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2694045|NCT01289782|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694046|NCT01289782|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694047|NCT01289782|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694048|NCT01289782|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694049|NCT01289782|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as greater than or equal to 2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694050|NCT01289782|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694051|NCT01289782|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694052|NCT01289782|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694651|NCT01285427|Primary|SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694053|NCT01289782|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694054|NCT01289782|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694055|NCT01289782|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694056|NCT01289782|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694057|NCT01289782|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, < 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694058|NCT01289782|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2694059|NCT01289782|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows the change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2694060|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694061|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694062|NCT01289782|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694063|NCT01289782|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2694064|NCT01289678|Primary|Event-free Survival|Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death|3 years||||Participants|||Count of Participants
2694065|NCT01289639|Secondary|Change in Hepatic Insulin Sensitivity|Hepatic insulin sensitivity was determined using stable glucose isotope measurements during the low dose hyperinsulinemic euglycemic clamp to determine the rate of endogenous glucose production in the fasting state and in response to a low dose glucose infusion. The ability of insulin to suppress glucose, which is mainly produced by the liver, thus provides a measure of hepatic insulin sensitivity and is expressed as a percentage of the basal state. Change in the ability of low dose insulin to suppress endogenous glucose production during a labeled hyperinsulinemic euglycemic clamp.|0-6 months||||% change from baseline||Standard Error|Mean
2694066|NCT01289639|Secondary|Change in Intra-abdominal Fat Area by CT Scan||0-6 months||||mm2||Standard Error|Mean
2694954|NCT01283321|Secondary|Number of Participants in Whom Transfusion of Platelet Concentrate is Required During or After Surgery.||Operative period up to 60 minutes||||Participants|||Count of Participants
2694067|NCT01289639|Secondary|Change in Peripheral Insulin Sensitivity|Change in the rate of glucose disposal (Rd) during the low dose clamp. During a clamp procedure, insulin is infused at a dose based on body size and a glucose solution is infused and the rate adjusted every 5 minutes based on a blood glucose reading to maintain the blood glucose stable at 90 mg/dl (normal level). Using glucose isotopes and the rate of the glucose infusion, we are then able to calculate how much glucose the liver is producing and how much glucose is being taken up into tissues. This provides a measure of insulin sensitivity.|0-6 months||||mg/minute/kg lean mass||Standard Error|Mean
2694068|NCT01289639|Secondary|Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT||0-6 months||||ratio||Standard Error|Mean
2694069|NCT01289639|Secondary|Change in Alanine Aminotransferase (ALT) Levels||0-6 months||||U/L||Standard Error|Mean
2694070|NCT01289639|Primary|Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan||6 months||||ratio||Standard Error|Mean
2694071|NCT01289574|Secondary|Percent Change in Noninflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized subjects|||Percentage change from baseline||Standard Deviation|Mean
2694072|NCT01289574|Secondary|Success on Investigator Global Assessment (IGA) at Week 12|"Overall acne rated as clear, almost clear, mild, moderate, severe, very severe.~Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline"|12 weeks|All randomized subjects|||Percentage of subjects|||Number
2694073|NCT01289574|Primary|Percent Change in Inflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized patients|||Percentage change from baseline||Standard Deviation|Mean
2694074|NCT01289548|Secondary|Plasma Concentration of MDA in the Recipients|Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the operation|All patients completed the trial and no dropout occured.|||nmol/ml||Inter-Quartile Range|Median
2694075|NCT01289548|Secondary|Plasma Concentration of SOD in the Recipients|Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within 24hours after the operation|All patients completed the trial and no dropout occured.|||U/ml||Inter-Quartile Range|Median
2694076|NCT01289548|Secondary|Urine Concentration of RBP Postoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.|||mg/L||Inter-Quartile Range|Median
2694077|NCT01289548|Secondary|Urine Concentration of RBP Preoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) before the operation in the recipients|before the operation|No urine could be obtained from the other 46 patients because of anuria.|||mg/L||Standard Deviation|Mean
2694078|NCT01289548|Secondary|Urine Concentration of NAG Postoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.|||U/L||Inter-Quartile Range|Median
2694079|NCT01289548|Secondary|Urine Concentration of NAG Preoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation|before operation|Urine could not be obtained from the other 46 patients because of anuria.|||U/L||Standard Deviation|Mean
2694080|NCT01289548|Secondary|Total Costs During the Hospitalization|Total costs from the admission to the discharge of the recipients|from the admission to the discharge of the patients|All the patients completed the study and no dropout occured.|||RMB yuan||Inter-Quartile Range|Median
2694081|NCT01289548|Primary|Plasma Concentration of NGAL in the Recipients|Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping|within the first 24hours after the operation|All patients completed the trial and no dropout occured.|||ng/ml||Inter-Quartile Range|Median
2694082|NCT01289548|Primary|Urinary Output of the Recipients Postoperatively|Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation|within the first 3days after the operation|All patients completed the trial and no dropout occured.|||ml||Inter-Quartile Range|Median
2694083|NCT01289548|Secondary|Length of Postoperative Hospital Stay|time from the day of operation to the day of discharge for the recipients|before discharge|All the patients completed the study and no dropout occured.|||day||Inter-Quartile Range|Median
2694084|NCT01289548|Secondary|Delayed Graft Function|Delayed Graft Function according to the clinical symptoms|before discharge|All the patients completed the study and no dropout occured.|||participants|||Number
2694085|NCT01289548|Secondary|Acute Rejection of Transplanted Kidney|biopsy-confirmed, clinically symptomatic|before discharge|All the patients completed the study and no dropout occured.|||participants|||Number
2694086|NCT01289548|Primary|Plasma Creatine Concentration of the Recipients|Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping|within the first 3days after the operation|All patients completed the trial and no dropout occured.|||μmol/l||Inter-Quartile Range|Median
2694087|NCT01289522|Secondary|Biomarkers||two years|||||||
2694088|NCT01289522|Secondary|Overall Survival||1 year|||||||
2694089|NCT01289522|Secondary|Progression-free Survival||1 year|||||||
2694090|NCT01289522|Secondary|Best Overall Response|Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.|12 weeks|2 patients not assessable for response at 12 weeks|||percentage of Best overall ORR||95% Confidence Interval|Number
2694091|NCT01289522|Secondary|Grade 1 to 5 Toxicity|All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.|24 weeks (average)||||percentage of events|||Number
2694986|NCT01282866|Secondary|Treatment Time|The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.|Each treatment||||minutes||Standard Deviation|Mean
2694092|NCT01289522|Primary|Objective Tumor Response Rate|"The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR."|12 weeks (after completion of the 4th cycle of chemotherapy)||||percentage of participants||95% Confidence Interval|Number
2694093|NCT01289457|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last Follow-up.|up to 2 years|The outcome measure for the Phase I portion of this study was to determine MTD only. Data Was not collected for Overall Survival for the Phase I arm of this study.|||Months||Full Range|Median
2694094|NCT01289457|Secondary|Event-Free Survival (EFS) at 2 Years|Comparison of the event-free survival (EFS) between treatment CIA and FLAI, where an event is defined to be resistance to treatment, relapse (after response) or death, whichever occurred first.|Up to 2 years or until relapse/death|The outcome measure for for the Phase I portion of this study was to determine MTD only. Data Was not collected for EFS for the Phase I arm of this study.|||Months||Full Range|Median
2694095|NCT01289457|Secondary|Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI)|NCI & Myelodysplastic syndromes (MDS) International Working Group (IWG) Definitions: Complete Response (CR): Neutrophil count ≥1.0 ×10^9/L, Platelet count ≥100 ×10^9/L, Bone marrow aspirate </=5% blasts, No extramedullary leukemia; CRi: Response as in CR but platelets <100 ×10^9/L; Partial response (PR): Neutrophil count ≥ 1.0 ×10^9/L, Platelet count ≥100 ×10^9/L, ≥ 50% reduction in bone marrow blasts over baseline; Clinical benefit: In addition to IWG criteria, in AML, a decrease in bone marrow blasts to <5% is also considered clinical benefit; Stable Disease: In addition to IWG criteria and in absence any of above response criteria, stable disease considered if the bone marrow blast percent does not increase compared to pretreatment level; Relapse: Increase of bone marrow blasts to >10% after initial response. Response assessed Day 28 of every 2-3 cycles during treatment.|12 months|The outcome measure for for the Phase I portion of this study was to determine MTD only. Data Was not collected for Response Rate for the Phase I arm of this study.|||Participants|||Count of Participants
2694096|NCT01289457|Primary|Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine|MTD is highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicities (DLT). Toxicity defined as any treatment-related grade 3 or greater non-hematological toxicities.|28 days|Maximum Tolerated Dose (MTD) is only reported for the Phase I portion of the study. MTD was not done on the Phase II portion of the study and therefore, PhII Groups 1 and 2 do not have results for MTD.|||mg/m^2|||Number
2694097|NCT01289418|Primary|the Occurrence of Serious Adverse Events (SAE)||6 months||||participants|||Number
2694098|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8, 15 and 29||||participants|||Number
2694099|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.||at day 8, 15 and 29||||participants|||Number
2694100|NCT01289392|Primary|Sleep Apnea|Number of events per hour of sleep|6 months||||number of events||Standard Deviation|Mean
2694101|NCT01289392|Secondary|Inflammatory Markers|Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8|6 months after the basal evaluation|||||||
2694102|NCT01289392|Primary|Objective Sleep Parameters|Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation|6 months after the basal evaluation|||||||
2694103|NCT01289275|Secondary|30-day Abstinence|All participants will receive an assessment Interview 2-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone.|2-months post enrollment|all randomized subjects|||percentage of participants||95% Confidence Interval|Number
2694104|NCT01289275|Secondary|Self-reported Re-hospitalization||6-months post enrollment||||Participants|||Count of Participants
2694105|NCT01289275|Secondary|Percentage of Smokers Making a 24-hour Quit Attempt||6-months post enrollment|all randomized subjects|||percentage of participants||95% Confidence Interval|Number
2694106|NCT01289275|Primary|Percentage of Participants With 30-day Abstinence|All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.|6-months post enrollment|all randomized subjects|||percentage of participants||95% Confidence Interval|Number
2694107|NCT01289210|Secondary|Assess the Safety and Feasibility of the Combination Regimen.||Safety assessed throughout study period.|||||||
2694108|NCT01289210|Primary|Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.|Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.|Tumor assessment conducted at 12 weeks and every 3-6 months thereafter|Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint).|||participants|||Number
2694109|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥2.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2702551|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 6 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 6 month||||number of episodes||Standard Deviation|Mean
2694110|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2694111|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2694112|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥ 0.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2694113|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2694114|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.0% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2694115|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤6.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
2694116|NCT01289119|Secondary|Change From Baseline in Body Weight|The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.|Baseline and Weeks 8 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline weight assessment. Last observation carried forward was utilized.|||kg||Standard Error|Least Squares Mean
2694117|NCT01289119|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).|Randomization to Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline assessment.|||percentage of participants|||Number
2694118|NCT01289119|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8, 12 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline FPG assessment. Last observation carried forward was utilized.|||mmol/L||Standard Error|Least Squares Mean
2694119|NCT01289119|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8 and 12.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2694120|NCT01289119|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2694121|NCT01289080|Secondary|The Abnormalities Found in Vital Signs, ECGs, and Clinical Laboratory Tests Are Reported as AEs Upon Study Physicians Discretion.|An adverse event (AE) was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.|AEs were recorded from Screening (ICF was signed) to Follow-up 31 (+ 2) days.|The dataset for all safety analyses consisted of the data from all enrolled participants who received at least 1 dose of study medication, regardless of any protocol deviation. All observed data for these subjects were included.|||participants|||Number
2694122|NCT01289080|Secondary|Fraction of the Systemically Available Brexpiprazole Metabolite (DM-3411) Excreted Into the Urine (fe,u).|Urine samples were collected at Predose and at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||% of unbound brexpiprazole in urine.||Standard Deviation|Mean
2694123|NCT01289080|Secondary|Renal Clearance (CLr) of Brexipiprazole Metabolite (DM-3411).|Urine samples were collected at Predose at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2694124|NCT01289080|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. The terminal phase elimination half-life was not determined for DM-3411 metabolite.|||h||Standard Deviation|Mean
2694125|NCT01289080|Secondary|Apparent Unbound Clearance From Plasma After Extravascular Administration of Brexpiprazole (CLu/F).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2694126|NCT01289080|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||% of unbound brexpiprazole in plasma||Standard Deviation|Mean
2694127|NCT01289080|Secondary|Apparent Clearance From Plasma After Extravascular Administration of Brexpiprazole (CL/F).|The value of CL/F was determined as Dose/AUC∞. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
2694128|NCT01289080|Secondary|Time to Cmax of Brexiprazole Metabolite (DM-3411) (Tmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||h||Full Range|Median
2694129|NCT01289080|Secondary|Maximum Plasma Concentration of Brexpiprazole Metabolite (DM-3411) (Cmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
2694130|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUC∞ was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. AUC-time curve from zero to infinity (AUC∞) was not determined for DM-3411 metabolite.|||ng*h/mL||Standard Deviation|Mean
2694131|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole Metabolite (DM-3411) Calculated to the Last Observable Concentration at Time t (AUCt).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUCt was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2694132|NCT01289080|Primary|Unbound Maximum (Peak) Plasma Concentration of Brexpiprazole (Cmax,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
2694133|NCT01289080|Primary|Unbound Area Under AUC- Time Curve From Time Zero to Infinity (AUC∞,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
2694134|NCT01289080|Primary|Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u).|Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for pharmacokinetics (PK) analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||nanograms*hours/mL (ng*h/mL)||Standard Deviation|Mean
2694135|NCT01289067|Secondary|Overall Survival|Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.|24 months||||days||Full Range|Median
2694136|NCT01289067|Secondary|Progression Free Survival (PFS)|Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression.|up to 2 years||||days||Full Range|Median
2694137|NCT01289067|Secondary|Number of Days to Maximum Decline in PSA|Response rate - Maximum decline in PSA that occurs during treatment.|baseline and 3 months|Only responders included|||days||Full Range|Median
2694138|NCT01289067|Primary|Efficacy of Satraplatin as Second Line Therapy in Men With CRCP|Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.|3 months||||participants|||Number
2694139|NCT01289041|Secondary|Overall Survival (OS) According to PI3K Activation Pathway Status|Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months|Full analysis set includes all patients who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2694140|NCT01289041|Secondary|Progression Free Survival (PFS) According to PI3K Activation Pathway Status|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|24 months|Full analysis set includes all patients who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2694141|NCT01289041|Primary|Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status|BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|24 months|Full analysis set includes all patients who received at least one dose of study drug.|||number of participants|||Number
2694142|NCT01289028|Secondary|Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.|Progression-free survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.|during 12 months||||days||95% Confidence Interval|Median
2694143|NCT01289028|Secondary|Overall Survival, Number of Events Related to Progression of the Disease|The OS rate could not be calculated due to the high number of censored cases. Number of censored, n (%) 108 (86.4). Only available data is number of events. OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died, survival was censored at date of last contact.|during 12 months||||events|||Number
2694144|NCT01289028|Secondary|Duration of Overall Response|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence|during 12 months||||days||95% Confidence Interval|Median
2694145|NCT01289028|Secondary|Time to Tumor Progression|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated as stated in section 9.8.3 of the clinical study report.|during the first 4 months|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated||||||
2694146|NCT01289028|Secondary|Time to Overall Response (CR or PR): Per Protocol Population|Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks||||percentage of participants|||Number
2694147|NCT01289028|Secondary|Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population|Complete Response (CR): Disappearance of all target lesions. and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks|ITT population|||percentage of participants|||Number
2694148|NCT01289028|Primary|Percent of Patients Achieving Complete Response (CR)|Complete response (CR) is the Disappearance of all target lesions.|during the first 4 months||||percentage of participants|||Number
2694149|NCT01289028|Primary|Percent of Patients Achieving Partial Response (PR)|The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|during the first 4 months|ITT set, N=125|||percentage of participants|||Number
2694150|NCT01289028|Primary|Percent of Patients Achieving Stable Disease (SD)|Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.|During the first 4 months||||% participants|||Number
2694151|NCT01289015|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).~Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6.|Full Analysis Set (FAS) using a Modified Intent to Treat population.|||percentage of subjects|||Number
2694152|NCT01289015|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.~Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because culture results were not available before the start of treatment.|||percentage of subjects|||Number
2694153|NCT01288989|Secondary|Anti-IMC-3C5 Antibody Assessment||Predose: First and fourth infusions (Cycle 1), ninth infusion (Cycle 3), 15th infusion (Cycle 4), 21st infusion (Cycle 6), 27th infusion (Cycle 7). (Cycle 1 = 4 - 6 weeks. Subsequent cycles = 4 weeks.)|Zero participants were analyzed. No assay was available to assess serum anti-IMC-3C5 antibodies.||||||
2694154|NCT01288989|Secondary|Minimum Concentration (Cmin) of IMC-3C5 - Fourth Infusion|Trough concentration (Ctrough) prior to fourth infusion of Cycle 1.|Prior to 4th infusion (approximately Day 22) of Cycle 1 for cohorts 1-5. (Cycle 1 = 4 - 6 weeks.)|All participants who received study drug and had sufficient evaluable Ctrough values.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2694155|NCT01288989|Secondary|Clearance (Cl) of IMC-3C5 at Steady State - Fourth Infusion||Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)|Cl was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable Cl values.|||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2694156|NCT01288989|Secondary|Volume of Distribution of IMC-3C5 at Steady State (Vss) - Fourth Infusion||Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)|Cohorts 1 - 3: Data not presented because extrapolated AUC was more than 30% and estimated Vss values may not be reliable. Cohort 4: All participants who received study drug and had sufficient evaluable Vss values.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2694157|NCT01288989|Secondary|Terminal Half-life (t1/2) of IMC-3C5 - Fourth Infusion||Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)|t1/2 was estimated in participants in cohorts 1-4 who received study drug and had sufficient evaluable t1/2 values.|||days||Full Range|Geometric Mean
2694158|NCT01288989|Secondary|Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion||Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)|AUCtau was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable AUCtau values.|||microgram*hour/milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2694159|NCT01288989|Secondary|Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion||Prior to 4th infusion (approximately Day 22, Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. Prior to 4th infusion, 1 hour post infusion for cohort 5. (Cycle 1 = 4-6 weeks.)|All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2694160|NCT01288989|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion||Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)|AUC 0-tlast was only measured in participants in cohorts 1-4, who received study drug and had sufficient evaluable AUC 0-tlast values.|||microgram*hour/milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2694161|NCT01288989|Secondary|Maximum Concentration (Cmax) of IMC-3C5 - First Infusion||Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. Prior to 1st infusion and 1 hour post infusion for cohort 5. (Cycle 1 = 4 - 6 weeks.)|All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2694162|NCT01288989|Secondary|Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir. Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline up to 46 Months|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2694163|NCT01288989|Primary|Number of Participants Reporting Dose-Limiting Toxicity (DLT)|"A DLT was defined as any adverse event (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0) considered by the investigator to be definitely, probably, or possibly related to IMC-3C5, that occurred during the DLT Assessment Period (weeks 1 through 6) as follows:~Any Grade 3 or 4 hematologic toxicity~Any Grade 3 or 4 nonhematologic toxicity (excluding fatigue or anorexia lasting <7 days, or Grade 3 nausea and/or vomiting that persisted for <2 days following appropriate supportive care intervention)"|Baseline up to 16 Months|All participants who received at least one dose of study drug. DLT was assessed in cohorts 1-4, only.|||Participants|||Count of Participants
2694164|NCT01288989|Primary|Number of Participants With Adverse Events (AEs)|AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.|Baseline up to 46 months|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2694165|NCT01288976|Secondary|Six Minute Walk Test Distance (6MWT)|The 6-minute walk distance test will be used to measure the patient's exercise capacity.|12 months|"The 6-MWT was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test at the12 month visit.~."|||meters||Standard Deviation|Mean
2694166|NCT01288976|Secondary|Six Minute Walk Test Distance (6MWT)|The 6-minute walk distance test will be used to measure the patient's exercise capacity.|Baseline|"The 6-minute walk test was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test at baseline.~."|||meters||Standard Deviation|Mean
2694167|NCT01288976|Secondary|Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months|"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)."|12 months|The MLWHF Questionnaire was not consistently administered to patients in the Medical Management&Mitral Valve Surgery groups.Thus MLWHF will not be reported for these comparator arms.Of the 567 MitraClip device patients,264 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&125 patients did not complete MLWHF Questionnaire.|||Quality of Life Score||Standard Deviation|Mean
2694168|NCT01288976|Secondary|The Change in 6 Minute Walk Test Distance From Baseline to 12 Months|The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline.|Baseline and 12 months|"The 6-minute walk test was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test.~."|||meters||Standard Deviation|Mean
2694169|NCT01288976|Secondary|NYHA Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity.Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea/anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea/anginal pain Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken,discomfort is increased."|At 12 month|NYHA Functional Class was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.Of total 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 .|||percentage of participants|||Number
2694170|NCT01288976|Secondary|NYHA Functional Class|"New York Heart Association (NYHA) Functional Classification.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.Less than ordinary physical activity causes fatigue, palpitation dyspnea or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased."|At baseline|NYHA Functional Class was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.A total of 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 .|||percentage of participants|||Number
2694171|NCT01288976|Secondary|Need for Mitral Valve Surgery|This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure.|Through 12 months|This outcome measure is reported only for the MitraClip device group. The need for mitral valve surgery was not captured in the Medical Management or the Mitral Valve Surgery groups.|||percentage of participants|||Number
2694172|NCT01288976|Secondary|1-Day Post-Procedure Safety Outcomes|This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported.|On day 1 post procedure|1-Day Post-Procedure Safety Outcomes are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups|||percentage of participants|||Number
2694173|NCT01288976|Secondary|Device Embolization and Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements."|Through 12 months|Device Embolization and Single Leaflet Device Attachment are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.|||participants|||Number
2694174|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 12 months|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants||95% Confidence Interval|Number
2694175|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 6 months|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants||95% Confidence Interval|Number
2694176|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 30 days|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants||95% Confidence Interval|Number
2694177|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 0 day|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants|||Number
2694178|NCT01288976|Secondary|Discharge MR Severity||At discharge, an average of 7.7 days following the MitraClip procedure|"MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups.MR severity will not be reported for these comparator arms.~A total of 521 MitraClip patients analyzed.Missing data is due to death(n=11),patient withdrawal(n=13),data unavailable(n=3),discharge echocardiogram not done/missing(n=19)."|||percentage of participants|||Number
2694179|NCT01288976|Secondary|Discharge Status and Facility||At discharge, an average of 7.7 days following the MitraClip procedure|Discharge Status and Facility is reported only for patients who underwent the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.Discharge Status and Facility outcomes data is available for 563 patients.|||percentage of participants|||Number
2694180|NCT01288976|Secondary|ICU and Hospital Stay|ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.|From the day of procedure throughout 12 months of study period|ICU and Hospital Stay is reported only for patients who underwent the MitraClip procedure.The Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||Days||Standard Deviation|Mean
2694181|NCT01288976|Secondary|Number of MitraClip Devices Implanted|Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis.|Day 0 (On the day of procedure)|Number of MitraClip Devices Implanted is reported only for patients who underwent the MitraClip procedure.The Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants|||Number
2694182|NCT01288976|Secondary|Fluoroscopy Duration||Day 0 (On the day of procedure)|"Fluoroscopy duration is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups~Fluoroscopy duration was not recorded for 99 of 567 patients. Therefore, Fluoroscopy duration is available for 468 patients"|||Minutes||Standard Deviation|Mean
2694183|NCT01288976|Secondary|Contrast Volume||Day 0 (On the day of procedure)|"Contrast volume is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.~Contrast volume was not recorded for 9 of 567 patients. Therefore, Contrast volume is available for 558 subjects."|||milliliter||Standard Deviation|Mean
2694184|NCT01288976|Secondary|Procedure Time|Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed.|Day 0 (On the day of procedure)|"Procedure time is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.~Procedure Time was not recorded for 196 of 567 patients.Therefore, the data is available for 371 patients."|||Minutes||Standard Deviation|Mean
2694185|NCT01288976|Primary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.~MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|At 12 months|MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at 12 months.|||percentage of participants|||Number
2694186|NCT01288976|Primary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.~MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|At baseline|MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at baseline.|||percentage of participants|||Number
2694187|NCT01288911|Secondary|Percentage of Participants With Adverse Events|"A serious adverse event was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life threatening~Resulted in persistent or significant disability/incapacity~Resulted in congenital anomaly or birth defect~Required inpatient hospitalization or led to prolongation of hospitalization~Other medically important events.~Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment. Treatment emergent adverse events (TEAEs) were defined as adverse events (AEs) that started or worsened after starting administration of study drug through end of the study (i.e., the treatment-emergent period)."|From initiation of study drug up to 30 days after last dose of study drug or the 30-day safety follow-up visit, whichever was last (Median duration of treatment was 11.6 months in enzalutamide arm and 5.8 in bicalutamide arm, 12.6 in the total arm).|Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)|||percentage of participants|||Number
2694188|NCT01288911|Secondary|Percentage of Participants With an Objective Response|Response assessments were reported by ICR for target lesions in soft tissues and non-target lesions in soft tissues based on CT and/or MRI according to RECIST version 1.1. Objective response was defined as the number of participants achieving either a complete response (CR) or a partial response (PR) based on participant's best overall response assessed at the end of the treatment.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||percentage of participants|||Number
2694189|NCT01288911|Secondary|Radiographic PFS Based on ICR Assessment|"Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression.~Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694190|NCT01288911|Secondary|Time to ≥ 90% PSA Decline From Baseline|The time to ≥ 90% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 90% was recorded. In participants without ≥ 90% PSA decline from Baseline, the time to ≥ 90% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694191|NCT01288911|Secondary|Time to ≥ 50% PSA Decline From Baseline|The time to ≥ 50% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 50% was recorded. In participants without ≥ 50% PSA decline from Baseline, the time to ≥ 50% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694192|NCT01288911|Secondary|Time to ≥ 30% PSA Decline From Baseline|The time to ≥ 30% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 30% was recorded. In participants without ≥ 30% PSA decline from Baseline, the time to ≥ 30% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694326|NCT01287416|Secondary|Gatekeeper Behaviours - Did Not Ask Person at Risk|Number of participants who did not ask someone about their suicidal thoughts even though they thought they were at risk, measured at 6 month follow-up assessment based on time since training.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||participants|||Number
2694193|NCT01288911|Secondary|Time to PSA ≤ 4 ng/mL|Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694194|NCT01288911|Secondary|Time to PSA Progression|Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for participants who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694195|NCT01288911|Secondary|Best PSA Response|The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.|Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set with available PSA data|||percent change||Full Range|Median
2694196|NCT01288911|Secondary|Prostate-specific Antigen (PSA) Response by Week 13|The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.|Baseline to Week 13|Full analysis set with available PSA data|||percent change||Full Range|Median
2694197|NCT01288911|Secondary|PFS Based on Investigator Assessment|"PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.~Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.~A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.~The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
2694198|NCT01288911|Primary|Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment|"PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.~Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.~A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.~The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set (all randomized participants)|||months||95% Confidence Interval|Median
2694199|NCT01288859|Primary|Amount of Total Fecal Polyphenols|Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.|0 and 24 hours post‐dose.||||nmol||Standard Error|Mean
2694200|NCT01288859|Primary|Urinary Excretion of Total Polyphenols|Area Under the Curve (AUC) from 0 to 24h of total polyphenols (sum of parent polyphenols and metabolites)was calculated using a trapezoidal rule applied to the urinary concentration-time curves of compounds.|Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post‐dose.|Basing on power analysis calculation on a previous work|||nmol•h/L||Standard Error|Mean
2694201|NCT01288859|Primary|Serum Polyphenol Concentrations Over 24h From Food Consumption|Area Under the Curves (AUC) from 0 to 24h of parent polyphenols was calculated using a trapezoidal rule applied to the concentration-time curves of compounds.|0, 0.5, 1, 2, 4, 6, and 24 hours post‐dose|The number of subjects was based on power calculations derived from our previous study. We calculated that, at α = 0.05 with a power of 80%, 8 subjects would allow us to detect a 20% difference in serum and urinary concentrations of parental compounds, glucuronides and phenolic acids.|||nmol*h/L||Standard Error|Mean
2694202|NCT01288833|Post-Hoc|Surveillance Colonoscopy Advanced Pathology Findings|Compare the advanced pathology and colon cancer incidence at surveillance colonoscopy of the groups who underwent high definition narrow band imaging colonoscopy with and without close focus features, and more specifically who underwent macroscopic versus microscopic polyp management. This applies if we bring the patient back after 5 years, we have not collected the data yet.|5 to 10 years after colonoscopy|||||||
2694203|NCT01288833|Secondary|Learning Curve|"Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist's first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps."|At time of procedure.|975 total polyps were found and we were able to make high confidence predictions on 774 of them.|||percentage of high confidence prediction|Diminutive polyps|95% Confidence Interval|Number
2694204|NCT01288833|Secondary|Accuracy of Predicted Versus Actual Surveillance Intervals|Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation.|At the time of procedure||||Participants|||Count of Participants
2694205|NCT01288833|Secondary|Diagnostic Characteristics|"Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.~Accuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps"|At time of procedure|975 total polyps were found with high confidence predictions made on 774 of them.We assessed diagnostic performance of the high confidence predictions. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology.|||percentage of high confidence prediction|Polyps analyzed|95% Confidence Interval|Number
2694206|NCT01288833|Secondary|Cost|"Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis.~A reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured)."|At the time of procedure||||Specimen bottles that could be omitted|||Number
2694207|NCT01288833|Primary|Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.|Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.|At the time of procedure|We analyzed all diminutive sized polyps to assess the number of polyps that endoscopists were able to make an accurate high confidence optical diagnosis. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (non-neoplasia) in the NICE classification and no features associated with the other histology.|||Percent of accurate HC predictions|Polyps analyzed|95% Confidence Interval|Number
2694208|NCT01288807|Secondary|Measure Concentrations of Serotonin and Norepinephrine Cerebrospinal Fluid and Plasma|"The investigators will measure cerebrospinal fluid and plasma concentrations of serotonin and norepinephrine in CSF and plasma before and after twelve (12) weeks of treatment with milnacipran.~Assays for these outcomes were not performed."|12 weeks|Assays for Norepinephrine and Serotonin were not performed.||||||
2694209|NCT01288807|Secondary|Measure Pain Ratings and Fibromyalgia Symptoms|"Fibromyalgia patients will be asked to keep a pain diary which assess spontaneous pain ratings daily, a subjective weekly assessment, as well as degree of improvement weekly during treatment period on a numeric rating scale.~The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 corresponding to 'No Pain' and 10 corresponding to 'Worst Pain imaginable'."|12 weeks|8 patients with fibromyalgia syndrom were recruited.|||score on a scale||Standard Deviation|Mean
2694210|NCT01288807|Secondary|Measure Sensory Thresholds for Pressure Pain|Investigator will utilize sensory testing to assess changes in sensory thresholds among patients with fibromyalgia before and after a twelve (12) week course of milnacipran.|12 weeks|8 patients with fibromyalgia syndrom were recruited|||lb/in(2)||Standard Deviation|Mean
2694211|NCT01288807|Secondary|Measure Sensory Threshold for Temperature Pain|Investigators will utilize quantitative sensory testing to assess changes in sensory thresholds among patients with fibromyalgia before and after a twelve (12) week course of milnacipran.|12 weeks|8 patients with fibromyalgia syndrom were recruited.|||Degree Celcius||Standard Deviation|Mean
2694212|NCT01288807|Primary|Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment.|"Measure levels of Substance P present in serial samples of CSF and plasma collected over the course of 4 hours in response to application of a painful thermal stimulus at baseline (before) and the end of 12 weeks of treatment with milnacipran 200mg daily (after).~Substance P levels are presented. Presented data show the 10 minute and 40 minute timepoint for Substance P after pain challenge. Additional time points were not analyzed."|12 weeks|8 patients with fibromyalgia were recruited for the study.|||pg/mL||Standard Deviation|Mean
2694213|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurements. 36 hours is defined at the 36 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 36 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
2694214|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 12 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
2694215|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 3 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
2694216|NCT01288781|Secondary|Change in Fluid Balance|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Urine output was recorded by 24 hour urine collection and fluid intake by 24 hour food diaries. Fluid balance was calculated as:~(urine output (L) / fluid intake (L) ) * 100."|Fluid Balance: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||% of fluid intake||Standard Deviation|Mean
2694217|NCT01288781|Secondary|Change in Blood Oxygen Saturation|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement.|Blood Oxygen Saturation: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||% oxygen saturation||Standard Deviation|Mean
2694218|NCT01288781|Secondary|Change in High Altitude Headache by Visual Analogue Scale|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache.|High Altitude Headache: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
2694219|NCT01288781|Primary|Change in Optic Nerve Sheath Diameter by Ultrasonography|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement.~24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure."|Optic Nerve Sheath Diameter: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
2694220|NCT01288729|Primary|Length of Wear of Infusion Site|Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).|5 weeks|Participants with available data were analyzed.|||hours||Inter-Quartile Range|Median
2694221|NCT01288612|Secondary|Acceptability|Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||percentage of participants|||Number
2694222|NCT01288612|Secondary|Mean Tolerability Scores|Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||units on a scale||Standard Deviation|Mean
2694223|NCT01288612|Secondary|Mean Time From Extubation to Discharge|This outcome measures the recovery time after the procedure.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||minutes||Standard Deviation|Mean
2694224|NCT01288612|Secondary|Mean Duration of Procedure|Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||minutes||Standard Deviation|Mean
2694225|NCT01288612|Secondary|Rate of Acquisition of Biopsies From the Esophagus||Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||percentage of participants|||Number
2694226|NCT01288612|Secondary|Rate of Complete Evaluation|The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||procedures|||Number
2694227|NCT01288612|Secondary|Rate of Successful Intubation|The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||percentage of participants|||Number
2694228|NCT01288612|Primary|Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment|This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.|Approximately 2 weeks after invitation letter was sent|The analysis population for this outcome measure was the number of subjects per group who were eligible to contact.|||percentage of participants|||Number
2694229|NCT01288534|Secondary|Frequency of Required Interventions.|To assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions.|5 years||||percentage of participants|||Number
2694230|NCT01288534|Secondary|Relation Between Reconstructed Delivered Dose Distributions.|To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.|5 years|Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed||||||
2694231|NCT01288534|Secondary|Relation Between Dose Distribution and Toxicities.|To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.|5 years|Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed.||||||
2694232|NCT01288534|Secondary|Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months|To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.|1 Year||||percentage of patients|||Number
2694233|NCT01288534|Primary|Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)|"To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.~Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months."|24 months||||percentage of patients|||Number
2694234|NCT01288521|Primary|Tacrolimus Bioavailability (F)|Tac bioavailability alone vs. Tac bioavailability with Keto. To determine F we took the ratio of area under the curve of the oral dose divided by the area under the curve of the IV dose. F was determined by fitting a model that considered the plasma concentration of tac with IV vs. oral dosing.|baseline and 2 weeks|Stable kidney transplant recipients|||ratio of oral to IV||Standard Deviation|Mean
2694235|NCT01288469|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameter analyzed|||ratio||Inter-Quartile Range|Median
2694236|NCT01288469|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment HDL-C value.|||percent change||Standard Error|Least Squares Mean
2694237|NCT01288469|Secondary|Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).|From baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.|||percent change||Inter-Quartile Range|Median
2694238|NCT01288469|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis||Week 8 (LOCF)|mITT population.|||percentage of participants|||Number
2694239|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.|||mg/dL||Standard Error|Least Squares Mean
2694240|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.|||mmol/L||Standard Error|Least Squares Mean
2694241|NCT01288469|Primary|Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 8 (LOCF)|Modified Intent-To-Treat (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2694242|NCT01288443|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for ApoB/ApoA-1 ratio analyzed.|||ratio||Standard Error|Least Squares Mean
2694243|NCT01288443|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.|||percent change||Inter-Quartile Range|Median
2694244|NCT01288443|Secondary|Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies the number of participants analysed for each lipid parameter.|||percent change||Standard Error|Least Squares Mean
2694245|NCT01288443|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.|||percentage of participants|||Number
2694246|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mg/dL||Standard Error|Least Squares Mean
2694247|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mmol/L||Standard Error|Least Squares Mean
2694327|NCT01287416|Secondary|Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts|Number of participants who have asked someone that they thought was at risk about suicidal thoughts since the training, measured at 6 month follow-up assessment.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||participants|||Number
2694248|NCT01288443|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first study drug injection up to 21 days after last study drug injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2694249|NCT01288287|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks|HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks.|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||units on a scale||Standard Deviation|Mean
2694250|NCT01288287|Secondary|Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks|"RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.~A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||units on a scale||Standard Deviation|Mean
2694251|NCT01288287|Secondary|Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline|"Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(ESR) ≤ 3.2 and decrease from baseline > 0.6 and ≤ 1.2,~DAS28(ESR) > 3.2 and ≤ 5.1 and decrease from baseline > 0.6,~DAS28(ESR) > 5.1 and decrease from baseline > 1.2 Patients without a good or moderate response are considered to be non-responders."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||percentage of patients|||Number
2694252|NCT01288287|Secondary|Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:~DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.~DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||units on a scale||Standard Deviation|Mean
2694253|NCT01288287|Primary|Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:~DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.~DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||percentage of patients||95% Confidence Interval|Number
2694254|NCT01288209|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|"The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of Overall represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng.h/mL||Full Range|Median
2694255|NCT01288209|Secondary|Plasma Concentrations of TMC435|"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of Overall representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
2694328|NCT01287416|Secondary|Attempted Suicide Since Training at 6 mo Follow-up|Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.|||participants|||Number
2702355|NCT01227629|Secondary|D-dimer: Difference From Baseline|Difference in D-dimer from baseline to last available value|baseline and 12 weeks|All randomised patients, only per-protocol data included.|||ng/ml||Standard Deviation|Mean
2694256|NCT01288209|Secondary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2694257|NCT01288209|Secondary|The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2694258|NCT01288209|Secondary|The Number of Participants Demonstrating Viral Relapse During the Study|The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2694259|NCT01288209|Secondary|The Number of Participants With Viral Breakthrough During the Study|The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable.|Up to EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2694260|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12|"The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the Number of Participants Analyzed. Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points."|Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2694261|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2694262|NCT01288209|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up.|Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2694329|NCT01287416|Secondary|Suicidal Ideation Since Training at 6 mo Follow-up|Number of people who endorsed having thought about suicide since the training as measured at 6 month follow-up (not at all vs a little to a lot)|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.|||participants|||Number
2694652|NCT01285427|Primary|All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)|All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694263|NCT01288209|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|EOT (Week 24 or 48) and Week 48 or 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2694264|NCT01288209|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (Week 24 or 48) and Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2694265|NCT01288079|Primary|Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment|A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2694266|NCT01288053|Primary|Survival|The number of participants who survived treatment|Up to five years|The number of participants who survived treatment|||participants|||Number
2694267|NCT01288027|Secondary|Percent Change From Baseline in Disease Activity Using T2 Magnetic Resonance Imaging (MRI) at Week 26|Disease activity (inflammation and/or water content within muscles) was quantitatively assessed by T2 MRI values in a subset of participants. A T2 MRI value of greater than (>) 39 millisecond (ms) was defined as abnormal. T2 estimation normally requires an additional acquisition for computing the B1 spatial deviation however, can still be estimated if this acquisition is missing.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here Number of participants analyzed = number of participants with both baseline and Week 26 assessment of disease activity.|||percent change||Standard Deviation|Mean
2694268|NCT01288027|Secondary|Percent Change From Baseline in Degree of Fatty Infiltration Using 3-Point 3-Dimensional (3D) Dixon at Week 26|Degree of Fatty Infiltration was assessed by 3-point 3D Dixon acquisition using skeletal muscle MRI in a subset of participants.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, number of participants analyzed = number of participants with both Baseline and Week 26 assessment of degree of fatty infiltration.|||percent change||Standard Deviation|Mean
2694269|NCT01288027|Secondary|Percent Change From Baseline in Muscle Involvement Using Mercuri Scoring at Week 26|Muscle involvement was assessed by T1-weighted magnetic resonance imaging (MRI). T1-weighted MRI data was analyzed using the Mercuri scoring in both legs (Total score = 1-4; where 1=Normal appearance, 2=Mild involvement, 3=Moderate involvement, and 4=Severe involvement). For each participants, the average for each the upper (thigh) and lower leg was computed for Mercuri grading.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, Number of participants analyzed= participants with both Baseline and Week 26 assessment of muscle involvement, n= number of participants with both Baseline and Week 26 assessment of muscle involvement for specified category.|||percent change||Standard Deviation|Mean
2694270|NCT01288027|Secondary|Lysosomal Inclusions||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.||||||
2694271|NCT01288027|Secondary|Muscle Fiber Morphology||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.||||||
2694272|NCT01288027|Secondary|Glycogen Distribution||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.||||||
2694273|NCT01288027|Primary|Change From Baseline in Tissue Glycogen Content in Quadriceps Muscle Biopsy Samples at Week 26|Tissue glycogen content was measured by quadriceps biopsies as 'percent area of tissue occupied by glycogen'.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, n = number of participants with both Baseline and Week 26 assessment of tissue glycogen content.|||percent area occupied by glycogen||Standard Deviation|Mean
2694274|NCT01287897|Secondary|Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."|||participants|||Number
2694275|NCT01287897|Secondary|Serum PF-04236921 Concentration Over Time||Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40|"The pharmacokinetic (PK) analysis set was the subset of participants from the SAS who provided at least 1 PK concentration (2 participants [10 mg arm] excluded due to a quality issue). n is the number of participants with PK data at the visit. From Weeks 16 to 40, only participants who remained in the follow-up period of this study were analyzed."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2694276|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)|The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."|||percentage of participants|||Number
2694277|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)|The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."|||percentage of participants|||Number
2694278|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||points on a scale||90% Confidence Interval|Least Squares Mean
2694279|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||points on a scale||90% Confidence Interval|Least Squares Mean
2694280|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694281|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694282|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694283|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694284|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694285|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694286|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.|Baseline and Week 12|The analysis was performed on FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694287|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 12|Primary analysis: FAS excluding 200 mg arm (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694298|NCT01287741|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores|The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.|Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)|The intent-to-treat (ITT) population included all randomized participants. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||score on a scale||Standard Deviation|Mean
2694988|NCT01282814|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2694288|NCT01287897|Primary|The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.|Baseline and Week 8|The analysis was performed on FAS participants of the 200 mg and placebo arms, referred to as FAS 200 mg versus (vs) placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694289|NCT01287897|Primary|The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 8|Primary analysis: full analysis set (FAS, defined as all randomized participants who received at least 1 dose of study treatment; 2 participants [10 mg arm] excluded due to a quality issue) excluding 200 mg (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).|||Percentage of participants||90% Confidence Interval|Least Squares Mean
2694290|NCT01287832|Secondary|Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity||30-42 days post-treatment|||||||
2694291|NCT01287832|Primary|Number of Participants With Clinical Success at Test of Cure Visit.|Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.|30-42 days post-treatment||||participants|||Number
2694292|NCT01287754|Secondary|Percentage of Participants With EGFR Mutation at Screening|Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.|Screening|All Participants Enrolled|||percentage of participants||95% Confidence Interval|Number
2694293|NCT01287754|Secondary|Percentage of Participants Alive at 6 and 12 Months|Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.|At 6 and 12 months|All Participants Enrolled|||percentage of participants|||Number
2694294|NCT01287754|Secondary|Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants|OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Enrolled: All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated participants, were included in the analysis.|||months||95% Confidence Interval|Median
2694295|NCT01287754|Secondary|Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1|Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated|||participants|||Number
2694296|NCT01287754|Primary|Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation|PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated: All participants who received at least one dose of erlotinib were included in the analysis.|||months||95% Confidence Interval|Median
2694297|NCT01287741|Secondary|Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)|Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.|C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)|The Pharmacokinetic assessment was done on a subset of 39 Japanese participants in the Obinutuzumab+Chemotherapy arm only.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2696135|NCT01272245|Secondary|Evaluation of CR Duration|The date of Complete Response to the date of loss of response or last follow-up.|Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.||||Months||Full Range|Median
2694299|NCT01287741|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score|The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.|Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)|The intent-to-treat (ITT) population included all randomized participants. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||score on a scale||Standard Deviation|Mean
2694300|NCT01287741|Secondary|Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab|The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.|Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)|The safety analysis population included all participants who received at least one dose of study drug. Because of serious Good Clinical Practice non- compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||percentage of participants|||Number
2694301|NCT01287741|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to approximately 6.5 years (up to 31 January 2018)|The safety analysis population included all participants who received at least one dose of study drug. Because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||percentage of participants|||Number
2694302|NCT01287741|Secondary|Time to Next Anti-Lymphoma Treatment (TTNALT)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.|Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||months||95% Confidence Interval|Median
2694303|NCT01287741|Secondary|Duration of Response (DOR), Investigator-Assessed|DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%.|Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||months||95% Confidence Interval|Median
2694304|NCT01287741|Secondary|Median Time to Disease-Free Survival (DFS), Investigator-Assessed|Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||months||95% Confidence Interval|Median
2694323|NCT01287520|Secondary|PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)|AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb.|Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle|All participants who received at least 1 dose LY2090314 coadministered with Pem and Carb and had enough samples to allow estimation of AUC0-∞ parameters excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.|||nanograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2694324|NCT01287520|Secondary|Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314|AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone.|Cycle 1 Day 1 of a 28 day cycle|All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the wrong dose of LY2090314.|||nanograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2694305|NCT01287741|Secondary|Median Time to Event-Free Survival (EFS), Investigator-Assessed|Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||months||95% Confidence Interval|Mean
2694306|NCT01287741|Secondary|Complete Response (CR) at the End of Treatment, IRC-Assessed|Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants.|Baseline up to approximately 4 years and 9 months (up to 29 April 2016)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2694307|NCT01287741|Secondary|Complete Response (CR) at the End of Treatment, Investigator-Assessed|Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.|Baseline up to approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||percentage of participants|||Number
2694308|NCT01287741|Secondary|Overall Response Rate (ORR), IRC-Assessed|Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants.|Baseline up to approximately 4 years and 9 months (up to 29 April 2016)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2694309|NCT01287741|Secondary|Overall Response Rate (ORR), Investigator-Assessed|Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.|Baseline up to approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||percentage of participants|||Number
2694310|NCT01287741|Secondary|Median Time to Overall Survival (OS)|Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause.|Baseline up to approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||months||95% Confidence Interval|Median
2694311|NCT01287741|Secondary|Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed|Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants.|Baseline up to approximately 4 years and 9 months (up to 29 April 2016)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2694325|NCT01287520|Primary|Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD])|Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of >5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval.|Baseline up to Day 28 (Cycle 1)|Safety population: all participants who have received at least 1 dose of the study drug.|||milligrams (mg)|||Number
2694312|NCT01287741|Primary|Median Time to Progression-Free Survival (PFS), Investigator-Assessed|Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to approximately 6.5 years (up to 31 January 2018)|The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis.|||months||95% Confidence Interval|Median
2694313|NCT01287611|Secondary|Length of Uterine Incision After Suturing|Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.|6 weeks after C/S||||cm||Standard Deviation|Mean
2694314|NCT01287611|Primary|Cesarean Scar Defect in the Uterine Incisional Line|A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.|6 weeks after C/S||||participants|||Number
2694315|NCT01287520|Secondary|Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin)|PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data.|Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles|There was insufficient data from participants who received at least 1 dose of LY2090314 to perform β-catenin modeling, thus zero participants were analyzed.||||||
2694316|NCT01287520|Secondary|PK Parameter: Cmax of Free Carboplatin|Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).|Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle|All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Carb Cmax data.|||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2694317|NCT01287520|Secondary|PK Parameter: AUC0-∞ of Free Carboplatin (Carb)|AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy).|Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle|All participants who were treated with Pem and Carb (doublet therapy) or Pem, Carb and LY2090314 (triplet therapy) and who had evaluable Carb AUC0-∞ data.|||hours*nanograms per milliliter per mg||Geometric Coefficient of Variation|Geometric Mean
2694318|NCT01287520|Secondary|PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)|Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy).|Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle|All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable Cmax Pem data.|||nanogram per milliliter per milligram||Geometric Coefficient of Variation|Geometric Mean
2694319|NCT01287520|Secondary|Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)|AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy).|Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle|All participants who were treated with Pem and Carb (doublet therapy) or who were treated with Pem, Carb and LY2090314 (triplet therapy) and had evaluable AUC0-∞ Pem data.|||hours*nanograms/milliliter/ milligram||Geometric Coefficient of Variation|Geometric Mean
2694320|NCT01287520|Secondary|Number of Participants With Best Overall Tumor Response|Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)|Analysis population: all participants who received at least 1 dose of study drug and had tumor response assessment.|||participants|||Number
2694321|NCT01287520|Secondary|PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)||Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle|All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2694322|NCT01287520|Secondary|PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314||Cycle 1 Day 1 of a 28-day cycle|All participants who received at least 1 dose of LY2090314 and had evaluable AUC0-∞ data, excluding 2 participants (1 in dose groups LY80 and 1 in dose group LY120) who received the incorrect dose of LY2090314.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2694330|NCT01287416|Secondary|Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training|Number of people who endorsed having thought about suicide in the past 2 days as measured immediately post training (not at all vs a little to a lot)|July 22-23, 2010|The smaller number of participants per group reflects the number of individuals who responded to the post-training questionnaire.|||participants|||Number
2694334|NCT01287416|Secondary|Self-reported Resiliency Score|Assesses resiliency in the participant according to the Connor-Davidson Resilience Scale, 10-item. The CD-RISC 10 is comprised of ten questions scored from 0 (Not at all true) to 4 (True nearly all of the time). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (low resiliency) to 40 (highly resilient).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||Scores on scale||Standard Error|Mean
2694335|NCT01287416|Secondary|Self-reported Alcohol Use|Details participants' level of alcohol consumption and if it may be harmful according to the AUDIT. The AUDIT scale is comprised of ten questions with most questions being scored from 0 (never) to 4 (4 or more times per week). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (no risk related to alcohol) to 40 (high risk related to alcohol). Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||Scores on a scale||Standard Error|Mean
2694336|NCT01287416|Secondary|Self-reported Distress|Measures the level of distress in the participant using the K6 distress scale. The scale is comprised of six questions which are scored from 0 (none of the time) to 4 (all of the time). The sum of the scores from all six questions was used to determine a total scale score which ranges from 0 (not at all distressed) to 24 (very distressed).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||Scores on a scale||Standard Error|Mean
2694337|NCT01287416|Secondary|Self-perceived Preparedness|Measures the level of preparedness of the individual to help someone who is suicidal based on a 4 point Likert scale ranging from 1 (not at all prepared) to 4 (very prepared).|pre-training, post-training and 6 month follow-up||||Scores on a scale||Standard Deviation|Mean
2694338|NCT01287416|Secondary|Self-perceived Knowledge About Suicide|Measures the level of knowledge about suicide that the individual believes they have based on a 4 point Likert scale ranging from 1 (not at all knowledgeable) to 4 (very knowledgeable).|pre-training, post-training and 6 month follow-up||||Scores on a scale||Standard Deviation|Mean
2694339|NCT01287416|Secondary|Self-perceived Skill in Helping a Suicidal Individual|Measures the level of ability that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all skilled) to 4 (very skilled).|pre-training, post-training and 6 month follow-up||||scores on a scale||Standard Deviation|Mean
2694340|NCT01287416|Secondary|Self-perceived Confidence in Helping a Suicidal Individual|Meaures the level of confidence that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all confident) to 4 (very confident).|pre-training, post-training and 6 month follow-up||||scores on a scale||Standard Deviation|Mean
2694341|NCT01287416|Primary|SIRI Questionnaire Score|The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.|pre-training, post-training and 6 mo follow up||||number of items correct||Standard Deviation|Mean
2694342|NCT01287403|Secondary|Phenolic Acids|Phenolic acids in plasma and urine|0-48 h post dose|||||||
2694343|NCT01287403|Secondary|Plasma and Urinary Betaine||From 0 to 48 hours post dose|||||||
2694344|NCT01287403|Primary|Plasma Alkylresorcinol Compounds|Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.|From 0 to 48 h post dose.||||nmol/L*h||Standard Deviation|Mean
2694345|NCT01287377|Secondary|Number of Participants With Serious Quit Attempts|A serious quit attempt is considered is a quit attempt that last more than 24 hours|2-months post enrollment|The number of participants analyzed is the number of participants the quitline was able to reach at 2-months post enrollment, not the number randomized into that condition|||Participants|||Count of Participants
2694346|NCT01287377|Primary|Number of Participants Who Have Not Used Tobacco in the Past 30 Days|At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.|2-months post enrollment|The number of participants analyzed is the number of participants the quitline was able to reach at 2-months post enrollment, not the number randomized into that condition|||Participants|||Count of Participants
2694347|NCT01287364|Primary|Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales|"Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables correlates with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors."|Day 1 (Pre-treatment) through Day 29|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.|||factor loadings|||Number
2694368|NCT01287195|Primary|Cytokine Production by PBMCs in Cell Culture|Cytokine production was assessed in cell cultures of PBMCs obtained from participants at baseline, Weeks 1, 3 and 5. The following cytokines were detected and are reported here: interferon gamma (IFN-gamma), interleukin (IL)-17A, IL-6, IL-1 beta, tumor necrosis factor (TNF) and IL-10.|Baseline, Weeks 1, 3 and 5|All participants enrolled in the study for whom data were available at each time point.|||picograms/milliliter (pg/mL)||Standard Deviation|Mean
2702552|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 3 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 3 month||||number of occurences||Standard Deviation|Mean
2694348|NCT01287364|Primary|Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)|"Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are small(0.2), medium (0.5), and large (0.8).~Between group SES indicates the magnitude of treatment differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)."|Day 1 (Pre-treatment) through Day 29|Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups.|||standard effect sizes|||Number
2694349|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|"Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)."|Day 1 (pre-treatment) through Day 7 Treatment Period 2|The rTNSS total period 2 change scores were partitioned into tertile ranges to form three groups: Low Change (-0.70 – -1.85; n = 55), Medium Change (-2.08 – -1.74; n = 56), or High Change (-6.57 – -2.14; n = 55).|||scores on a scale||Standard Error|Mean
2694350|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|"Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)."|Day 1 (pre-treatment) through Day 7 Treatment Period 1|The rTNSS total period 1 change scores were partitioned into tertile ranges to form three groups: Low Change (-1.04 – -4.93; n = 60), Medium Change (-2.49 – -1.05; n = 62), and High Change (-7.57 – -2.50; n = 61).|||scores on a scale||Standard Error|Mean
2694351|NCT01287364|Primary|Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)|Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62), Medium Symptoms (7.25 - 9.25; n = 61), or High Symptoms (9.33 - 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (Pre-treatment) through Day 7 Treatment Period 1|Baseline rTNSS was partitioned into tertile ranges and patients were assigned to Low (3.00 – 7.17; n = 62), Medium (7.25 – 9.25; n = 61), or High (9.33 – 12.00; n = 62) symptom groups.|||scores on a scale||Standard Error|Mean
2694352|NCT01287364|Primary|Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics|Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses [Cronbach's alpha (raw and standardized) coefficients were calculated]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.|Day 1 (Pre-treatment) through Day 7 Treatment Period 2|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.|||ratio of variance|||Number
2694353|NCT01287221|Secondary|Change in the COMPASS-Select-Change Scale From Baseline to 12 Months|"The change in COMPASS is a derivative of COMPASS and evaluates the change in symptoms over time on selected domains of symptoms as a function of natural history or intervention therapy. The focus is on 7 selected domains. The version of the COMPASS-Change -Select Scale used (06-09-2009 Ver. 1) has 16 questions, with multiple parts, scores ranging from much worse to no such symptoms. The score could range from 0 (no such symptoms) to 94 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
2694354|NCT01287221|Secondary|Change From Baseline to 12 Months in the COMPASS-Select Scale|"The composite autonomic symptoms score (COMPASS) provides a score of autonomic symptom severity with appropriate weighting. In the COMPASS_select, symptoms are confined to 6 select domains of symptoms. The version of the COMPASS-Select used (06-09-2009 v1) has 46 questions, with multiple parts, scores ranging from much worse to no such symptoms. Scores could range from 0 (no such symptoms) to 85 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
2694369|NCT01287195|Primary|T Cell Proliferation of PBMCs in Cell Culture|PBMCs isolated from whole blood obtained from participants at baseline, Weeks 1, 3, and 5 were assessed for proliferation in cell culture using a radioactive thymidine incorporation assay. A higher number indicates a higher level of proliferation.|Baseline, Weeks 1, 3 and 5|All participants enrolled in the study for whom data were available at each time point.|||radioactive counts of cells per minute||Standard Error|Mean
2694355|NCT01287221|Secondary|Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).~Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their total UMSARS scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale per month||Standard Deviation|Mean
2694356|NCT01287221|Secondary|Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II)|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
2694357|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part II|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part II could range from 0 (normal) to 56 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
2694358|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11)|UMSARS is a scale measuring disease progression that comprises 4 parts, only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
2694359|NCT01287221|Primary|Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11)|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).~Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles and no imputations were done for any missing values or slope estimates. All randomized participants who took at least two doses of the study drug were included in the principal efficacy analysis. One subject on the Rifampicin arm did not return after the baseline visit.|||units on a scale per month||Standard Deviation|Mean
2694360|NCT01287208|Secondary|Hours of Sleep Per Night|"Number of hours slept per night as recorded on activity device.~This secondary outcome was not measured in the trial."|12 weeks|This outcome was not collected because of logistical issues with obtaining this data without using an API.||||||
2694361|NCT01287208|Secondary|Weight||6 months||||Pounds||Standard Deviation|Mean
2694362|NCT01287208|Secondary|Calories Burned Per Day|Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.|12 weeks|This outcome was not collected because of logistical issues with obtaining this data without using an API.||||||
2694363|NCT01287208|Secondary|Distance Per Day|Distance in miles recorded on activity device.|12 weeks|This outcome was not collected because of logistical issues with obtaining this data without using an API.||||||
2694364|NCT01287208|Primary|Steps Per Day|Steps will be recorded on the activity device|12 weeks|We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization.|||steps per day||Inter-Quartile Range|Median
2694365|NCT01287195|Secondary|Score in Histologic Evaluation of Flexible Sigmoidoscopy|Mucosal biopsies were obtained from the most inflamed area seen during flexible sigmoidoscopy and blindly scored by a single pathologist with scores ranging 0-3 with a higher score indicating a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.|||score on a scale||Standard Error|Mean
2694366|NCT01287195|Secondary|Simple Clinical Colitis Activity Index (SCCAI) Score|SCCAI is a symptom based questionnaire addressing five assessments, including bowel frequency day, bowel frequency night, urgency of defecation, blood in stool and general well-being. Score ranges from 0-15 with one additional point added for each manifestation of extracolonic features. A higher score indicates a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.|||score on a scale||Standard Error|Mean
2694367|NCT01287195|Secondary|Mayo Score|The Mayo Score is determined by the investigator by assigning a score to the following four assessments: stool frequency, rectal bleeding, physician's global assessment and endoscopy. Total range for Mayo score is 0-12 with a higher score indicating a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.|||score on a scale||Standard Error|Mean
2696273|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population.Here, number of participants analyzed = participants who were BRAFi-naïve participants.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2694370|NCT01287195|Primary|Percentage of Biomarker-positive Immune Cells|Peripheral blood mononuclear cells were (PBMCs) were isolated from blood samples taken from each participant at baseline and Week 5. PBMCs were stained with a panel of fluorochrome-conjugated antibodies against multiple surface and intracellular biomarkers, including Cluster of Differentiation (CD) 3, CD4, CD8, Forkhead box P3 protein (FOXP3) and latency-associated peptide (LAP). The percentage of T cells positive for each of these biomarkers was determined by fluorescence activated cell sorting (FACS) and the mean percentage of positive T cells for each biomarker for all analyzed participants is reported.|Baseline, Week 5|All participants enrolled in the study for whom data were available at both time points.|||percentage of biomarker-positive T cells||Standard Deviation|Mean
2694371|NCT01287195|Primary|Number of Participants With Anti-Drug Antibodies|Serum samples were obtained to measure anti-drug antibodies during the study.|From baseline to Week 10|All participants enrolled in the study.|||Participants|||Count of Participants
2694372|NCT01287195|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From baseline to Week 10|All participants enrolled in the study.|||Participants|||Count of Participants
2694373|NCT01287117|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
2694374|NCT01287117|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|"The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded No to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit."|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage||Standard Deviation|Mean
2694375|NCT01287117|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2694376|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2694377|NCT01287117|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
2694378|NCT01287117|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
2694379|NCT01287117|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Weeks||95% Confidence Interval|Median
2694380|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2694390|NCT01287104|Primary|Number of Patients Who Received the Highest Dose Level of NK Cells (1x10^6 NK Cells/kg for Patients With Related Donors and 1 x10^5 NK Cells/kg for Patients With Unrelated Donors) With Sustained Donor Lymphoid Engraftment|Donor engraftment is defined as >95% donor lymphoid chimerism (cluster of differentiation 3+T-cells on peripheral blood).|100 days|This outcome measure does not apply to donors as they did not receive the treatment intervention. Three patients in SG2 where not included because they did not receive any NK cell infusions. Four patients in SG3 were not included because they did not receive any NK cell infusions.|||Participants|||Count of Participants
2694381|NCT01287117|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2694382|NCT01287117|Primary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2694383|NCT01287104|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned|Date treatment consent signed to date off study, approximately 65 months and 2 days.||||Participants|||Count of Participants
2694384|NCT01287104|Secondary|Number of Participants With Presence of Killer-cell Immunoglobulin-like Receptors (KIR) Gene Mismatch|Blood samples and/or buccal swabs were obtained and the presence of Killer-cell immunoglobulin-like receptors (KIR) genes was determined by locus specific polymerase chain reaction (PCR) amplification followed by gel electrophoresis. KIR receptors were examined for a mismatch in the human leukocyte antigen (HLA) ligand. A mismatch in the HLA ligand can signal increased anti-tumor activity, enhanced engraftment, and/or less infectious complications for patients.|Prior to stem cell transplant (Day 0)|This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.|||Participants|||Count of Participants
2694385|NCT01287104|Secondary|Number of Participants With a Decline in Interleukin 7 (IL-7) and Interleukin 15 (IL-15) Cell Numbers Post-Transplant|Cytokine levels are checked in a multiplex format according to manufacturer's instructions (Meso Scale Discovery, Gaithersburg, Maryland, United States of America (USA).|3 years|This outcome measure was not performed.The data was not collected for this outcome measure because the original Principal Investigator departed the institution. The protocol was transferred to a new Principal Investigator who elected not to pursue this outcome.||||||
2694386|NCT01287104|Secondary|Number of Occurrences of Viral Infection and/or Reactivation in Allogeneic Peripheral Blood Stem Cell Transplant (PBSCT) Followed by Natural Killer-donor Lymphocyte Infusion (NK-DLI)|One or more occurrences of a new infection, reactivation or both (e.g. cytomegalovirus + flu, for example). Viral infections increase a patient's risk for a worse outcome and viral reactivation is a marker for T-cell immune dysregulation (i.e., inflammation).|Within 1-year post-transplant|This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.|||viral infections/reactivations|||Number
2694387|NCT01287104|Secondary|Overall Survival Since Date of Transplant|Overall survival is defined as the time from date of transplant until date of death or date last known alive.|Up to 36 months post-transplant|This outcome measure does not apply to donors as they did not undergo transplant. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.|||Months||95% Confidence Interval|Median
2694388|NCT01287104|Secondary|Disease-free Survival|Disease free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions.|12 months post-transplant|This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.|||Months||95% Confidence Interval|Median
2694389|NCT01287104|Secondary|Number of Participants With Mild, Moderate and/or Severe Chronic Graft Versus Host Disease (cGVHD)|Chronic graft versus host disease was assessed by the National Institutes of Health Consensus Criteria. Severity is rated mild moderate or severe on a scale of 0 (no symptoms) -3 (severe symptoms) . Mild is signs and symptoms that do not interfere substantially with function and do not progress once appropriately treated with local therapy. Moderate is signs and symptoms interfere somewhat with function despite appropriate therapy. Severe is signs and symptoms limit function substantially despite appropriate therapy. Low grade is best outcome and high grade is worse outcome.|up to 3 years post-transplant|This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.|||Participants|||Count of Participants
2694391|NCT01287104|Primary|Number of Patients Who Received 2 Doses of Natural Killer (NK) Cell Infusions|Participants received 2 doses of natural killer infusions within 56 days of hematopoietic stem cell transplant (HSCT).|within 56 days of hematopoietic stem cell transplant (HSCT)|This outcome measure does not apply to donors as they did not receive the treatment intervention. Two participants in SG2 and three participants in SG3 were not analyzed because they did not receive a transplant.|||Participants|||Count of Participants
2694392|NCT01287065|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN) and total bilirubin >=2 x ULN or international normalised ratio >1.5. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)|All Subjects Population: all participants who received at least one dose of the study medication.|||Participants|||Number
2694393|NCT01287065|Secondary|AM and PM Pre-treatment Trough FEV1 on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Trough FEV1 is defined as pre-dose (AM and PM) FEV1 measurement taken on Day 14. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant baseline, period baseline, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=23).|Day 14|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2694394|NCT01287065|Secondary|Pre-treatment PEF (AM and PM) on Days 1-12.|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 2 to 12 was analyzed. The analysis was performed using a mixed effect analysis of covariance model with fixed effect terms for treatment and period; baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=26). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=24).|From Day 2 up to Day 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||95% Confidence Interval|Least Squares Mean
2694395|NCT01287065|Primary|Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0-24 Hours Post-dose on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).|Pre-dose on Day 14 to 24 hours post-dose|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication and provided at least one post-dose peak expiratory flow (PEF) or FEV1 measurement. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2694396|NCT01287039|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|The immunogenicity of reslizumab was assessed by measuring for the presence of anti-reslizumab antibodies at baseline, weeks 16, 32, 48, and 52 or early withdrawal. Blood samples for anti-reslizumab antibodies assessment were also obtained from all patients (inside or outside of the US) experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.|Weeks 16, 32, 48 and 52|Safety analysis set. Immunogenicity for anti-reslizumab antibodies not reported for the placebo treatment arm.|||participants|||Number
2694397|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse - high 12-17 yr: >100 and increase of >= 30 beats/minute (bpm)~Sitting pulse - low >=18 yr: <50 and decrease of >=30 bpm~Sitting pulse - high >=18 yr: >100 and increase of >=30 bpm~Sitting systolic blood pressure - low >=18 yr: <90 and decrease of >=30 mmHg~Sitting systolic blood pressure - high >=18 yr: >160 and increase of >=30 mmHg~Sitting diastolic blood pressure - low 12-17 yr: <55 and decrease of >=12 mmHg~Sitting diastolic blood pressure - low >=18 yr: <50 and decrease of >=12 mmHg~Sitting diastolic blood pressure - high >=18 yr: >100 and increase of >=12 mmHg~Respiratory rate >=18 yr: >24 and increase of >=10 breaths/minute~Body temperature - low 12-17 yr: <96.5° Fahrenheit or <35.8° Celsius~Body temp - low >=18 yr: <96.5° F or <35.8° C~Body temp - high >=18 yr: >100.5° Fahrenheit"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set|||participants|||Number
2694398|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 5-49 U/L.~Bilirubin: >=34.2 μmol/L~White blood cells: <=3.0 or >20 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Neutrophils: <=1.0 10^9/L~Eosinophils: >10.0 %~Platelets: <75 or >=700 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set|||participants|||Number
2696962|NCT01265550|Secondary|Number of Enrolled Participants With Chronic Idiopathic Nausea||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for chronic idiopathic nausea|||Participants|||Count of Participants
2694399|NCT01287039|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Week 52|Randomized set|||CAEs in 52 weeks||95% Confidence Interval|Mean
2694400|NCT01287039|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set|||participants|||Number
2694401|NCT01287039|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.~The during treatment average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set of participants with assessments within timeframe|||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
2694402|NCT01287039|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (Weeks 4, 8, 12 and 16) SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set of participants with assessments within the timeframe|||puffs/day||Standard Error|Least Squares Mean
2694403|NCT01287039|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.~The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2694404|NCT01287039|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 478 (longest treatment time plus 2 weeks)|Randomized set|||weeks||95% Confidence Interval|Median
2694405|NCT01287039|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2694406|NCT01287039|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of patients with assessments at both timepoints|||units on a scale||Standard Error|Least Squares Mean
2694407|NCT01287039|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Positive change from baseline scores indicate improvement in asthma control.~The during treatment (Weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set, including participants who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
2694408|NCT01287039|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.~Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Week 52|Randomized set|||CAEs in 52 weeks||95% Confidence Interval|Mean
2694409|NCT01287013|Secondary|Rates of Definitive Pathologic Diagnosis|Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||percent of accuracy|||Number
2694410|NCT01287013|Secondary|Compare the Number of Repositioning Maneuvers|To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||number of repositioning maneuvers||Standard Deviation|Mean
2694411|NCT01287013|Primary|Radiation Doses Between Xperguide and Conventional CT|Comparing radiation doses to determine if there is a change in the dose between the two interventions|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||mGy||Standard Deviation|Mean
2694412|NCT01287013|Primary|Accuracy of Final Device Path (Vector)|Comparing the accuracy of the path the biopsy needle took to get to the site|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||mm||Standard Deviation|Mean
2694413|NCT01287013|Primary|Comparing the Accuracy of Final Device Tip Position|To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||mm||Standard Deviation|Mean
2694414|NCT01286987|Other Pre-specified|Part 1: Apparent Volume of Distribution (Vz/F) of Talazoparib|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was influenced by the fraction absorbed.|Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.|||liter||Standard Deviation|Mean
2694415|NCT01286987|Other Pre-specified|Part 1: Apparent Oral Clearance (CL/F) of Talazoparib|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.|Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.|||liter/hour||Standard Deviation|Mean
2694502|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
2694416|NCT01286987|Other Pre-specified|Part 1: Terminal Half-Life (t1/2) of Talazoparib|T1/2 is the time measured for the plasma concentration of talazoparib to decrease by one half.|Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.|||Hours||Standard Deviation|Mean
2694417|NCT01286987|Other Pre-specified|Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of Talazoparib|AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.|Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.|||pg*hr/mL||Standard Deviation|Mean
2694418|NCT01286987|Other Pre-specified|Part 1: Minimum Observed Plasma Concentration (Cmin) of Talazoparib||Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 35|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. Data for this outcome measure was not planned to be analyzed for Part 2, as pre-specified in protocol.|||pg/mL||Standard Deviation|Mean
2694419|NCT01286987|Other Pre-specified|Part 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib|Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).|Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.|||pg*hr/mL||Standard Deviation|Mean
2694420|NCT01286987|Other Pre-specified|Part 1: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUC0-last) of Talazoparib|Area under the plasma concentration time-curve from zero to the time of last measured concentration (AUC0-last).|Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.|||picograms*hour per mililiter (pg*hr/mL)||Standard Deviation|Mean
2694421|NCT01286987|Other Pre-specified|Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib||Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.|||hours||Full Range|Median
2694422|NCT01286987|Other Pre-specified|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib||Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.|||hours||Full Range|Median
2694423|NCT01286987|Other Pre-specified|Part 2: Maximum Observed Plasma Concentration (Cmax) of Talazoparib||Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1|The PK evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints. PK data was planned to be reported for the overall participants in Part 2, as pre-specified in protocol.|||pg/mL||Standard Deviation|Mean
2694424|NCT01286987|Other Pre-specified|Part 1: Maximum Observed Plasma Concentration (Cmax) of Talazoparib||Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35|The pharmacokinetic (PK) evaluable population included all participants who received at least 1 dose of talazoparib with adequate PK results to perform PK calculations and was used for analysis of PK endpoints.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2694425|NCT01286987|Other Pre-specified|Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to 1071 days for Part 1 and up to 834 days for Part 2) that were absent before treatment or that worsened relative to pre-treatment state.|Part 1: Baseline up to 1071 days; Part 2: Baseline up to 834 days|Safety analyses set included all enrolled participants who received at least 1 dose of talazoparib.|||participants|||Number
2694426|NCT01286987|Primary|Part 1: Recommended Part 2 Dose of Talazoparib|The Recommended dose of talazoparib for use in Part 2 was determined in Part 1 (dose escalation) on the basis of the totality of safety, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.|Baseline up to Cycle 50 (each cycle 28 days)|Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.|||mcg/day|||Number
2694450|NCT01286805|Secondary|Readiness to Discharge From Post-Anesthesia Care Unit (PACU)|Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.|Day of surgery prior to discharge||||minutes||Standard Deviation|Mean
2694451|NCT01286805|Primary|Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge|The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.|Day of surgery prior to discharge||||units on a scale||Standard Deviation|Mean
2694427|NCT01286987|Primary|Part 1: Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose Limiting Toxicity (DLT). DLT defined as any of the following occurring during cycle 1 of part 1 of study, Hematologic toxicity: Any grade 4 or higher hematologic adverse event, Grade 3 thrombocytopenia associated with grade 2 or higher haemorrhage, Grade 3 thrombocytopenia or neutropenia that led to interruption of dosing for 5 or more days. Nonhematologic toxicity: grade 3 or higher laboratory AE which was asymptomatic and rapidly reversible adverse events (returned to baseline or to grade 1 or lower within 7 days), Grade 3 nausea, vomiting, or diarrhea that could be medically managed to grade 2 or lower with anti-emetics and/or anti-diarrheals within 24 hours, Grade 3 fatigue that improved to grade 2 or lower in 5 days or less, Alopecia. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.|Cycle 1 (Day 1 up to Day 42)|Safety analysis set included all enrolled participants who received at least 1 dose of talazoparib.|||mcg/day|||Number
2694428|NCT01286987|Primary|Number of Participants With Stable Disease|SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).|Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)|Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for “Part 1: Colorectal Cancer” arm, as pre-specified in protocol.|||participants|||Number
2694429|NCT01286987|Primary|Duration of Response|Duration of response was defined as the time (in weeks) from the date of the first documented objective response confirmed at least 28 days later to the date of the first documented PD or date of death, whichever occurred first. PD as per RECIST version 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).|Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)|Analysis performed on subset of response analysis population which included participants who had objective response. Data for outcome measure was planned to be analyzed combined for Part 1 and Part 2. “Overall number of participants analyzed” is zero (0) for arms of ewing, prostate, CLC cancer, since none of the participants had objective response.|||weeks||95% Confidence Interval|Median
2694430|NCT01286987|Primary|Progression-Free Survival (PFS)|PFS was defined as the time (in weeks) from the date of first dose of study drug to the earlier date of the documented PD or death due to any cause. PD as per RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).|Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of talazoparib. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for “Part 1: Colorectal Cancer” arm, as pre-specified in protocol.|||weeks||95% Confidence Interval|Median
2694431|NCT01286987|Primary|Number of Participants With Best Overall Response|Best overall response: best response (in the order of confirmed CR, confirmed PR, stable disease [SD] and progressive disease [PD]) among all overall response as RECIST 1.1, recorded from date of first dose of talazoparib until participant withdrew from study/data cut-off date, whichever earlier. CR defined as disappearance of all non-nodal target lesions (where all target lesions recorded with a length of 0 mm on the CRF) and the reduction of the shortest diameter of all nodal lesions to < 10 mm. PR defined as at least a 30% decrease in sum of the diameters of target lesions, reference to baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).|From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)|Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type and was not planned to be analyzed for “Part 1: Colorectal Cancer” arm, as pre-specified in protocol.|||participants|||Number
2694432|NCT01286987|Primary|Number of Participants With Objective Response|Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter [mm] on the case report form [CRF]) and the reduction of the shortest diameter of all nodal lesions to less than [<] 10 mm. PR was defined by a 30% or more decrease in the sum of the longest diameters (SLD) + sum of shortest diameters (SSD) of target lesions, taking as reference the baseline SLD+SSD.|From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)|Response analysis population: all enrolled participants who had at least 1 dose of talazoparib, and measurable disease at baseline. Data for this outcome measure was planned to be analyzed combined for Part 1 and Part 2 on the basis of cancer type.|||participants|||Number
2694433|NCT01286870|Primary|Safety by Method of Resolution of Adverse Events||4 Years|"The study was prematurely discontinued. The sample size was not large enough for statistical significance.~Because only 11 subjects were enrolled in the Becker CA Study, demographic information and key safety information were listed by subject only and no formal summary tables were prepared."|||Procedures|||Number
2694434|NCT01286870|Primary|Safety by Incidence, Severity, and Duration of Adverse Events||4 Years|"The study was prematurely discontinued. The sample size was not large enough for statistical significance.~Because only 11 subjects were enrolled in the Becker CA Study, demographic information and key safety information were listed by subject only and no formal summary tables were prepared."|||Events|||Number
2694534|NCT01286311|Secondary|Frequency of Clinical Encounters|This will measure the difference in frequency of clinical encounters in the electronic medical record.|9 months||||% of patients with any office visit|||Number
2694435|NCT01286818|Secondary|Best Overall Response [Anti-Tumor Activity of FOLFIRI Plus Ramucirumab (IMC-1121B)]|Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Every 8 weeks until PD (up to 49 weeks)|Safety population: Participants who received any quantity of study medication.|||participants|||Number
2694436|NCT01286818|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab|Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Vss data at the specified time points.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2694437|NCT01286818|Secondary|Clearance (CL) of Ramucirumab|The total body CL of ramucirumab on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered CL at steady state (CLss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable CL data at the specified time points.|||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
2694438|NCT01286818|Secondary|Half Life (t1/2) of Ramucirumab|t1/2 is the time required for the plasma/serum concentration to decrease 50%.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable t1/2 data at the specified time points.|||days||Geometric Coefficient of Variation|Geometric Mean
2694439|NCT01286818|Secondary|Area Under the Curve (AUC) of Ramucirumab|Reported for Day 1, Cycle 1 is AUC from time 0 extrapolated to infinity [AUC(0-inf)] and for Day 1, Cycle 5 is AUC over the dosing interval at steady state AUC(tau,ss).|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable AUC data at the specified time points.|||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2694440|NCT01286818|Secondary|Maximum Concentration (Cmax) of Ramucirumab|The Cmax of ramucirumab in serum on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered Cmax at steady state (Cmax,ss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Cmax data at the specified time points.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2694441|NCT01286818|Secondary|Number of Participants With Serum Anti-IMC-1121B Antibodies (Immunogenicity)||Day 1 of Cycle 5 (Week 9), Cycle 6 (Week 11), Cycle 7 (Week 13), and Cycle 9 (Week 17) [(1 cycle=14 days)]|Participants who received any quantity of study medication and had evaluable immunogenicity data at the specified time points.|||participants|||Number
2694442|NCT01286818|Primary|Number of Participants With Ramucirumab Drug-Related Adverse Events or Serious Adverse Events|Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. Events related to Irinotecan, Levofolinate, and 5-fluorouracil (5-FU) were reported separately. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline to end of study (up to 49.3 weeks) plus 37 day follow-up|Safety population: Participants who received any quantity of study medication.|||participants|||Number
2694443|NCT01286818|Primary|Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period|DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count <1.0x10^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein >3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT.|Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days)|DLT population: All enrolled participants who either completed the first 3 administrations of study medication or discontinued study medication due to a DLT during the DLT assessment period (Day 1, Cycle 1 through Day 1, Cycle 3).|||participants|||Number
2694444|NCT01286805|Secondary|Quality of Recovery (QoR-40) Physical Comfort Dimension|Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome|First 24 hours after surgery||||QoR-40 Physical Comfort score||Standard Deviation|Mean
2694445|NCT01286805|Secondary|Patient Satisfaction|Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)|First 24 hours after surgery||||units on a scale||Standard Deviation|Mean
2694446|NCT01286805|Secondary|Requirement of Antiemetic Rescue|The number of participants who needed medication to treat their nausea and vomiting.|Day of surgery prior to discharge||||participants|||Number
2694447|NCT01286805|Secondary|Incidence of Vomiting|The number of participants who vomited.|Day of surgery prior to discharge||||participants|||Number
2694448|NCT01286805|Secondary|Incidence of Nausea|The number of participants with nausea.|Day of surgery prior to discharge||||participants|||Number
2694449|NCT01286805|Secondary|Narcotic Pain Medication Needed||Day of surgery prior to discharge||||equivalents milligrams oral morphine||Standard Deviation|Mean
2694535|NCT01286311|Primary|Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction|Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline|9 months||||% of patients with major LDL reduction|||Number
2694452|NCT01286779|Secondary|Changes in Health Related Quality of Life (HR QoL) Based on Questionnaire EQ-5D and Pain Score.|"The EQ-5D captures overall HR QoL (phyiscal, mental and social functioning). A health utility score can be calculated from this measure, adult and proxy versions available.~EQ-5D Visual Analog Scale (EQ-5D VAS):Respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints (scale range from 0 to 100). Score 0 corresponds to the worst health you can imagine and score 100 corresponds to the best health you can imagine (collected scores ranged from 10-100).~EQ-5D Total Index is based on general population valuation surveys. Responses to 5 questions are converted to an Index value and score range from 0 to 1, with higher scores indicating better quality of life. Total Index was derived on US population (collected scores ranged from 0.4-1).~General pain assessment (Pain score) is done through a visual analog scale (VAS), scores ranging from 0 to 100 with higher scores indicating more pain (collected scores ranged 0-87)."|Baseline at exposure day 1 and at study completion/termination.|Only newly recruited participants are included as baseline values were not reported for transitioning participants. Only subjects how received prophylaxis treatment are included.|||Score on a scale||Standard Deviation|Mean
2694453|NCT01286779|Secondary|Changes in Health Related Quality of Life (HR QoL) Based on Questionnaire Haemo-QoL and Haem-A-QoL|"The Hemophilia Quality of Life Questionnaire (Haemo-QoL) and the Hemophilia Quality of Life Questionnaire for Adults (Haem-A-Qol) instruments have been developed and used in hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: physical health, sports/leisure, school/work, dealing with hemophilia, and outlook for the future.~Haemo-QoL is used for participants aged 8 to 16 years and total scores range from 0 to 100 with higher scores indicating low quality of life (collected scores ranged from 0.0 to 44.3) Haem-A-QoL is used for participants aged 17 years and older and total scores range from 0 to 100 with higher scores indicating low quality of life (collected scores ranged from 4.9 to 76.8)."|Baseline at exposure day 1 and at study completion/termination.|Only newly recruited participants are included as baseline values were not reported for transitioning participants. Only subjects how received prophylaxis treatment are included.|||Score on a scale||Standard Deviation|Mean
2694454|NCT01286779|Secondary|Changes in Health Related Quality of Life Using the Peds QL|"The Pediatric Quality of Life Inventory (Peds QL) is a generic health related quality of life instrument designed specifically for a pediatric population and captures following domains: physical functioning, emotional functioning, social functioning and school functioning.~The Peds-QL total score consist of all 23 items of all domains. Score range from 0-100 and higher scores indicate better quality of life (collected scores ranged from 44.6 to 98.9).~The Peds-QL Physical Health Summary score consists of 8 items from the physical functioning domain. Score range from 0-100 and higher scores indicate better quality of life (collected scores ranged from 40.6 to 100.0) The Psychosocial Health Summary score consists of 15 items from the emotional, social and school functioning domains. Score range from 0 to 100 and higher scores indicate better quality of life (collected scores ranged from 46.7 to 100.0)."|Baseline at exposure day 1 and at study completion/termination.|Only newly recruited participants are included as baseline values were not reported for transitioning participants. Only subjects how received prophylaxis treatment are included.|||Score on a scale||Standard Deviation|Mean
2694455|NCT01286779|Secondary|Changes in Health Related Quality of Life (HR QoL) Based on Questionnaire SF-36|The Short Form (36) Health Survey (SF-36) is a 36-item validated, generic HR QoL instrument suitable for participants of 17 years of age or older. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health, mental health, physical role functioning, emotional role functioning, social role functioning) which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The mental health component summary score ranged from 19.5 to 64.2 with higher scores indicating less disability. The physical health component summary scores ranged from 18.6 to 59.6 with higher scores indicating less disability.|Baseline at exposure day 1 and at study completion/termination.|Only newly recruited participants are included as baseline values were not reported for transitioning participants. Only subjects how received prophylaxis treatment are included.|||Score on a scale||Standard Deviation|Mean
2694456|NCT01286779|Secondary|Pharmacokinetics: Incremental Recovery (IR)|PK infusion with investigational product was administered after a wash out period of at least 5 days. Incremental recovery is calculated as IR30min = (C30min [IU/dL] - Cpre-infusion [IU/dL]) / dose per kg body weight [IU/kg] where C30min and Cpre-infusion relate to the unadjusted concentration values.|PK assessments were done within 30 minutes pre-infusion and post-infusion at 30 (± 5) minutes, 9 hours (± 30 minutes), 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The pharmacokinetic analysis set comprises all participants who underwent an abbreviated PK study.|||(IU/dL):(IU/kg)||Standard Deviation|Mean
2694457|NCT01286779|Secondary|Pharmacokinetics: Volume of Distribution at Steady State (Vss)|PK infusion with investigational product was administered after a wash out period of at least 5 days. Apparent steady state volume of distribution is calculated as Vss = CL * MRT CL=Systemic Clearance and MRT=Mean residence time|PK assessments were done within 30 minutes pre-infusion and post-infusion at 30 (± 5) minutes, 9 hours (± 30 minutes), 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours|The pharmacokinetic analysis set comprises all participants who underwent an abbreviated PK study.|||dL/kg||Standard Deviation|Mean
2694458|NCT01286779|Secondary|Pharmacokinetics: Systemic Clearance (CL)|PK infusion with investigational product was administered after a wash out period of at least 5 days. Systemic clearance is balculated as the dose in IU/kg divided by the total AUC. CL= Dose[IU/kg] / AUC0-∞[h*IU/dL]|PK assessments were done within 30 minutes pre-infusion and post-infusion at 30 (± 5) minutes, 9 hours (± 30 minutes), 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours|The pharmacokinetic analysis set comprises all participants who underwent an abbreviated PK study.|||dL/kg/hours||Standard Deviation|Mean
2694501|NCT01286558|Secondary|Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Deviation|Mean
2694459|NCT01286779|Secondary|Pharmacokinetics: Mean Residence Time (MRT)|PK infusion with investigational product was administered after a wash out period of at least 5 days. Mean residence time is calculated as total area under the moment curve divided by the total area under the curve. MRT=(AUMC0-∞[h2*IU/dL])/(AUC0-∞[h*IU/dL]) - TI/2 where AUMC0-∞ is determined in a similar manner as AUC0-∞ and TI represents infusion duration in hours.|PK assessments were done within 30 minutes pre-infusion and post-infusion at 30 (± 5) minutes, 9 hours (± 30 minutes), 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours|The pharmacokinetic analysis set comprises all participants who underwent an abbreviated PK study.|||hours||Standard Deviation|Mean
2694460|NCT01286779|Secondary|Pharmacokinetics: Elimination Phase Half-life (T1/2)|PK infusion with investigational product was administered after a wash out period of at least 5 days. Elimination phase half-life is calculated as T1/2=log e (2) / lambda z where the elimination rate constant (lambda z) will be obtained by log e - linear fitting using least squares deviation to at least the last 3 quantifiable concentrations above pre-infusion level.|PK assessments were done within 30 minutes pre-infusion and post-infusion at 30 (± 5) minutes, 9 hours (± 30 minutes), 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours|The pharmacokinetic analysis set comprises all participants who underwent an abbreviated PK study.|||hours||Standard Deviation|Mean
2694461|NCT01286779|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC 0-∞)|After a wash out period of at least 5 days PK infusion with investigational product was administered. AUC 0-∞ is defined as AUC 0-t + Ct/lambda z, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration.|PK assessments were done within 30 minutes pre-infusion and post-infusion at 30 (± 5) minutes, 9 hours (± 30 minutes), 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours|The pharmacokinetic analysis set comprises all participants who underwent an abbreviated PK study.|||IU*hr/dL||Standard Deviation|Mean
2694462|NCT01286779|Secondary|Pharmacokinetics: Incremental Recovery (IR) Over Time|PK infusion with investigational product was administered after a wash out period of at least 5 days. Incremental recovery is calculated as IR30min = (C30min [IU/dL] - Cpre-infusion [IU/dL]) / dose per kg body weight [IU/kg] where C30min and Cpre-infusion relate to the unadjusted concentration values.|IR over time was measured as Baseline and at Completion/Termination visit within 30 minutes pre-infusion and at 30 (± 5) minutes post-infusion.|Analysis was done on all participants who received investigational product. All cases with a dosage higher than 120 IU/kg were excluded from the analysis.|||(IU/dL):(IU/kg)||Standard Deviation|Mean
2694463|NCT01286779|Secondary|Clinical Significant Changes in Routine Laboratory Parameters and Vital Signs|"Hematology panel consists of complete blood count (hemoglobin, hematocrit, erythrocytes, leukocytes) with differential (ie, basophils, eosinophils, lymphocytes, monocytes, neutrophils), mean corpuscular volume, mean corpuscular hemoglobin concentration and platelet count.~Clinical chemistry panel consists of sodium, potassium, chloride, bicarbonate, total protein, albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine and glucose.~Vital signs include body temperature, respiratory rate, pulse rate, supine systolic and diastolic blood pressure. CS=clinically significant, NCS=not clinically significant. Change from Screening to End of Study is reported."|Measurements at screening and at study completion/termination are included in the analysis.||||Participants|||Count of Participants
2694464|NCT01286779|Secondary|Occurrence of Severe Allergic Reactions and Thrombotic Events|The occurrence of severe allergic reactions and thrombotic events was assessed.|Throughout the study from screening to study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).||||Participants|||Count of Participants
2694465|NCT01286779|Secondary|Development of Antibodies to Chinese Hamster Ovary Proteins (CHO Proteins) and rFurin|"Testing for antibodies to CHO proteins and rFurin. Development during study means negative at screening and positive at any subsequent visit.~Treatment emergent means more than 2-dilution increase as compared to the pre-study titer at screening."|Laboratory assessment for immunology were done at screening, at exposure day 1, at week 4 (± 1 week), at month 3 (±1 week), thereafter, every 3 months (± 1 week) and at study completion/termination.||||Participants|||Count of Participants
2694466|NCT01286779|Secondary|Development of Inhibitory and Total Binding Antibodies to Factor IX|"Testing for inhibitory and total binding antibodies to Factor IX (FIX). Development during study means negative at screening and positive at any subsequent visit.~Treatment emergent means more than 2-dilution increase as compared to the pre-study titer at screening."|Laboratory assessment for immunology were done at screening, at exposure day 1, at week 4 (± 1 week), at month 3 (±1 week), thereafter, every 3 months (± 1 week) and at study completion/termination.||||Participants|||Count of Participants
2694467|NCT01286779|Secondary|Consumption of BAX326: Weight Adjusted Consumption Per Bleeding Episode|The weight adjusted consumption of BAX 326 per bleeding episode for the prophylactic and on-demand treatment regimens. Only infusions required until the resolution of bleed are considered.|Throughout the study from screening to study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).||||IU/kg|Bleeding episodes|Standard Deviation|Mean
2694468|NCT01286779|Secondary|Consumption of BAX 326: Weight Adjusted Consumption Per Month and Per Year|The weight adjusted consumption of BAX 326 per month and per year for the prophylactic and on-demand treatment regimens.|Throughout the study from screening to study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).||||IU/kg||Standard Deviation|Mean
2694469|NCT01286779|Secondary|Consumption of BAX 326: Number of Infusions Per Month and Per Year|The number of infusions consumed per month and per year for the prophylactic and on-demand treatment regimens.|Throughout the study from screening to study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).||||Number of infusions||Standard Deviation|Mean
2694470|NCT01286779|Secondary|Annualized Bleed Rate During Prophylaxis Treatment|Annualized bleed rate (ABR) was calculated as (number of bleeding episodes/observed treatment period in days)*365.25|For prophylactic treatment the period from first to last prophylactic infusion is considered.|Only participants with an observation period of at least 3 months with BAX326 on prophylactic treatment were included in the analysis.|||Bleeds per year||Full Range|Median
2694471|NCT01286779|Secondary|Treatment of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Resolution of Bleed|"Overall clinical efficacy rating of bleeding episodes was done at resolution of bleed according these rating scale:~Excellent=Full relief of pain and cessation of objective signs of bleeding after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusion would not affect the scoring.~Good=Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair=Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution.~None=No improvement or condition worsens."|Throughout the study from screening to study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).|Only bleeding episodes that were exclusively treated with BAX 326 are considered.|||Number of infusions|Bleeding Episodes||Number
2694472|NCT01286779|Secondary|Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode Required Until Bleed Resolution|Number of Infusions of BAX326 that were required until bleed resolution.|Throughout the study from screening to study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).|Only bleeding episodes that were exclusively treated with BAX 326 are considered.|||Number of infusions|Bleeding episodes|Standard Deviation|Mean
2694473|NCT01286779|Primary|Adverse Events Possibly or Probably Related to the Investigational Product|Possibly or probably related adverse events that occurred during or after first BAX326 infusion.|Assessed (based on patient diary) every 3 months until study completion (when BAX326 is licensed in the respective country or the participant has accumulated approximately 100 exposure days to BAX 326, whichever is last).||||Adverse Events|||Number
2694474|NCT01286753|Secondary|Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the drug or biologic concentration in the body following administration.|Up to approximately 4 years|Data were not collected for this outcome.||||||
2694475|NCT01286753|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)|Safety population, defined as enrolled participants who received at least one dose of study treatment.|||percentage of participants|||Number
2694476|NCT01286753|Secondary|Overall Survival|Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment.|From the date of first treatment to the date of death for any cause (up to approximately 4 years)|Intent-to-Treat population, defined as all enrolled participants.|||months||95% Confidence Interval|Median
2694477|NCT01286753|Secondary|Progression-Free Survival|Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the day of first treatment until the first documented PD or death (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||months||95% Confidence Interval|Median
2694478|NCT01286753|Secondary|Duration of Response|Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||months||95% Confidence Interval|Median
2694479|NCT01286753|Secondary|Clinical Benefit Rate|Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||percentage of participants||95% Confidence Interval|Number
2694480|NCT01286753|Secondary|Best Overall Response Rate in TKI-Experienced Participants|Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||percentage of participants||95% Confidence Interval|Number
2694481|NCT01286753|Primary|Best Overall Response Rate in TKI-Naive Participants|Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||percentage of participants||95% Confidence Interval|Number
2694482|NCT01286740|Secondary|Plasma Concentration of RPV at Week 48|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.|Week 48|Participants with evaluable measurements for plasma concentration of RPV at Week 48 were analyzed.|||ng/mL||Standard Deviation|Mean
2694483|NCT01286740|Secondary|Plasma Concentration of RPV at Week 36|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.|Week 36|Participants with evaluable measurements for plasma concentration of RPV at Week 36 were analyzed.|||ng/mL||Standard Deviation|Mean
2694484|NCT01286740|Secondary|Plasma Concentration of RPV at Week 24|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.|Week 24|Participants with evaluable measurements for plasma concentration of RPV at Week 24 were analyzed.|||ng/mL||Standard Deviation|Mean
2694485|NCT01286740|Secondary|Plasma Concentration of EFV at Week 12|The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12|Week 12|Participants with evaluable measurements for plasma concentration of EFV at Week 12 were analyzed.|||ng/mL||Inter-Quartile Range|Mean
2694486|NCT01286740|Secondary|Plasma Concentration of RPV at Week 12|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.|Week 12|Participants with measurements for plasma concentration of RPV at Week 12 were analyzed.|||ng/mL||Standard Deviation|Mean
2694487|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 8|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.|Week 8|Participants with evaluable measurements for plasma concentration of RPV and EFV at Week 8 were analyzed.|||ng/mL||Standard Deviation|Mean
2694488|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 6|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.|Week 6|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 6 were analyzed.|||ng/mL||Standard Deviation|Mean
2694489|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 4|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.|Week 4|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 4 were analyzed.|||ng/mL||Standard Deviation|Mean
2694490|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 2|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.|Week 2|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 2 were analyzed.|||ng/mL||Standard Deviation|Mean
2694491|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 1|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.|Week 1|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 1 were analyzed.|||ng/mL||Standard Deviation|Mean
2694492|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.|Week 48|Full Analysis Set|||percentage of participants|||Number
2694493|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set|||percentage of participants|||Number
2694494|NCT01286740|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.|Week 12|Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation|||percentage of participants|||Number
2694495|NCT01286558|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||participants|||Number
2694496|NCT01286558|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||percentage of participants|||Number
2694497|NCT01286558|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||percentage of participants|||Number
2694498|NCT01286558|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP >=140 mmHg at reference baseline|||percentage of participants|||Number
2694499|NCT01286558|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated DBP >=90 mmHg at reference baseline|||percentage of participants|||Number
2694500|NCT01286558|Secondary|Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Deviation|Mean
2694503|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
2694504|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
2694505|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
2694506|NCT01286558|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|FAS|||mm Hg||Standard Error|Least Squares Mean
2694507|NCT01286558|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|Full analysis set (FAS)|||mm Hg||Standard Error|Least Squares Mean
2694508|NCT01286493|Primary|Rabies Neutralizing Antibody Titers|"Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.~for 7 times in 1 year."|Day 360|As preliminary study, the number of participants was estimated to be above 15 - 20 cases.|||IU/ml||Full Range|Geometric Mean
2694509|NCT01286480|Secondary|MyHeart Score|Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD|Baseline, 1 month and 6 months||||percentage of score||Standard Deviation|Mean
2694510|NCT01286480|Primary|Transition Readiness Assessment Questionnaire (TRAQ) Score|"The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of No, I do not know how and a score of 5 assigned for responses of Yes, I always do this when I need to. The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy."|Baseline, 1 month and 6 months|The intervention involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.|||units on a scale||Standard Deviation|Mean
2694511|NCT01286454|Secondary|Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.|||hr||Standard Deviation|Mean
2694512|NCT01286454|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2694513|NCT01286454|Primary|Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2694514|NCT01286454|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2694536|NCT01286272|Other Pre-specified|Predictive Value of Fludeoxyglucose-positron-emission Tomography|The ratio will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data.|Up to 36-38 weeks (6-8 weeks after course 6, day 1 after last course of induction chemotherapy)|||||||
2694515|NCT01286454|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2694516|NCT01286441|Secondary|Number of Subjects Achieving Partial Resolution of Treated Warts|Partial Resolution is defined as >/= 75% Reduction of treated wart|12 weeks|FAS population used for this outcome measure.|||Participants|||Count of Participants
2694517|NCT01286441|Primary|Complete Resolution of All Treated Warts by or at Week 12|During the Treatment Period, subjects will apply study medication to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. Clinical evaluations, including wart counts, wart measurements and recording of adverse events and concomitant medications will be performed. Photographs of the treatment area will be taken at all study visits|12 weeks|FAS population was used for this outcome measure|||Participants|||Count of Participants
2694518|NCT01286402|Secondary|Perinatal/Neonatal Outcomes||at neonatal discharge from hospital following delivery|||||||
2694519|NCT01286402|Secondary|Maternal Side Effects||during treatment, end of treatment and at 2 week postpartum visit|||||||
2694520|NCT01286402|Secondary|Self-reported Reduction in Number of Cigarettes Smoked Per Day||at 1 week post treatment and at 2 week postpartum visit|||||||
2694521|NCT01286402|Secondary|Continuous Abstinence From Birth to 2nd Week Postpartum Followup||at 2nd week postpartum followup visit|||||||
2694522|NCT01286402|Secondary|Continuous Abstinence From End of Treatment Through the 2 Week Followup||at two week followup visit|||||||
2694523|NCT01286402|Secondary|Enrollment, Retention and Compliance Rates||1 year (estimated)|||||||
2694524|NCT01286402|Primary|7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment||1 week post treatment||||participants|||Number
2694525|NCT01286324|Secondary|Changes From Baseline in the Safety and Tolerability of Chamomile|Changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo were measured by counting all participants who reported a serious or non-serious adverse event at the weekly check-ins that were established.|once per week during study and day 28||||Participants|||Count of Participants
2694526|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]|the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})|Baseline and 28 days|Before first participants completed the study, the decision was made not to gather this data for reasons of cost.||||||
2694527|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale|"Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale (FSS) Range: 9 to 63. The 9-item scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.~The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity."|Baseline and 28 days||||units on a scale||Standard Deviation|Mean
2694528|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures: STAI|Change From Baseline of Chamomile on Daytime Functioning Measures, depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI). STAI scores range for each subtest from 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale|Baseline and 28 days||||units on a scale||Standard Deviation|Mean
2694529|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures: BDI|"Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:~the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II), which is scored on a scale of 0 to 63 where a total score of 0-13 is considered minimal range (minimal depression), 14-19 is mild, 20-28 is moderate, and 29-63 is severe."|baseline and day 28||||units on a scale||Standard Deviation|Mean
2694530|NCT01286324|Primary|Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.|"Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:~the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals The total sleep time divided by time-in-bed, multiplied by 100. This measure is our primary aim (SE)."|baseline and day 28||||percentage of time asleep||Standard Deviation|Least Squares Mean
2694531|NCT01286311|Secondary|Presence of an Aspirin Prescription|This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.|9 months|38 patients in the intervention arm and 50 patients in the control arm had aspirin listed in their medication list in the electronic medical record as the start of the study therefore they were excluded from this analysis.|||% patients w/aspirin now on med list|||Number
2694532|NCT01286311|Secondary|Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed|This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months.|9 months|Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included.|||percentage of participants|||Number
2694533|NCT01286311|Secondary|Medication Prescriptions for Dyslipidemia|This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.|9 months||||% of patients with New Rx for LLM|||Number
2694538|NCT01286272|Other Pre-specified|Pre-treatment Single Nucleotide Polymorphisms (SNP)|The PFS will be compared among the three genotype groups of each SNP using the log-rank tests. A maxtype test will be used by taking the maximum value of the log-rank tests under dominant, recessive, and proportional hazard model. The critical value (or p-value) of the max test will be obtained by a permutation method. No multiple testing adjustment may be applied because of the small sample size.|Up to 10 years|||||||
2694539|NCT01286272|Secondary|The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment|The number of patients who experienced grade 3+ hematologic and non-hematologic adverse events at least possibly related to treatment assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization||||Participants|||Count of Participants
2694540|NCT01286272|Secondary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS rates (percentages) at 1, 2, ,3 and 4 years are defined as the percentage of patients who are alive and progression-free at the respective time points. The p-values of the log-rank test will be calculated to compare PFS between the two arms.|Up to 4 years||||percentage of patients||95% Confidence Interval|Number
2694541|NCT01286272|Primary|Complete Response Rate|"A complete response was defined using International Harmonization Project Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~The complete response (CR) rate was calculated in newly diagnosed untreated follicular lymphoma patients receiving 6 cycles of ofatumumab-bendamustine (ARM A) and 6 cycles of ofatumumab, bortezomib, and bendamustine (ARM B).~The complete response rate was calculated as the number of patients with a complete response divided by the number of patients eligible for evaluation."|From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization|All patients that were eligible for response assessment were included in this analysis.|||proportion of patients|||Number
2694542|NCT01286207|Primary|Number of Participants With Drug-related Lab Adverse Experiences|"Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE).~A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product."|Up to 12 weeks|All patients who took study medication and had lab test(s)were included in the analysis.|||participants|||Number
2694543|NCT01286207|Primary|Number of Participants Who Discontinued Due to Clinical Adverse Experiences||Up to 12 months|All patients who took study medication were included in the analysis.|||participants|||Number
2694544|NCT01286207|Primary|Number of Participants With Drug-related Clinical Adverse Experiences|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Up to 12 months|All patients who took study medication were included in the analysis.|||participants|||Number
2694545|NCT01286207|Primary|Number of Participants With Serious Clinical Adverse Experiences|Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Up to 12 months|All patients who took study medication were included in the analysis.|||participants|||Number
2694546|NCT01286207|Primary|Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug|Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.|2 hours after initial dose of test drug|All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.|||percent of headaches||Inter-Quartile Range|Median
2694547|NCT01286168|Secondary|Per Drain Analysis: Drain Bulb Fluid Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.|||drains|Participants||Number
2694548|NCT01286168|Secondary|Per Drain Analysis: Drain Tubing Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.|||drains|Participants||Number
2694549|NCT01286168|Primary|Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week||Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.|||drains|Participants||Number
2694550|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 1 Year||Approximately one year after surgery||||participants|||Number
2694551|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 30 Days||Approximately 30 days after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.|||participants|||Number
2694552|NCT01286168|Secondary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.|Approximately 2 weeks after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.|||participants|||Number
2696963|NCT01265550|Secondary|Number of Enrolled Participants With Belching Disorders||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for belching disorders|||Participants|||Count of Participants
2694553|NCT01286168|Secondary|Number of Subjects With Drain Tubing Colonization at Removal|Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.|Approximately two weeks after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.|||participants|||Number
2694554|NCT01286168|Primary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.|Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.|||participants|||Number
2694555|NCT01286129|Secondary|Change in Nasal Lavage Eosinophils After Allergen Challenge|Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge|At 7 hours post first and last challenge compared to baseline||||percentage of nasal lavage eosinophils||Standard Error|Mean
2694556|NCT01286129|Primary|Change in Sputum Eosinophils Following Allergen Challenge|Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.|At 7 hours post first and last challenge compared to baseline||||percentage of sputum eosinophils||Standard Error|Mean
2694557|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as PR based on IMWG response criteria as >=50% reduction of serum and reduction in 24-h urinary M protein by >=90% or to <200 mg/24 h; or serum/urine M protein unmeasurable:>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: >=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was >=30%; or plus if present at baseline: >=50% reduction in size of soft tissue plasmocytomas.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Percentage of participants|||Number
2694558|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of >=25% from lowest response level in any one or more of the following: serum M protein (absolute increase >=0.5 g/dl)c or urine M protein (absolute increase >=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase >10 mg/dL; or % bone marrow plasma cells: absolute value >=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Percentage of participants|||Number
2694559|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as VGPR based on IMWG response criteria if, a) serum/urine M protein detectable by immunofixation but not on electrophoresis or; b) greater than or equal to 90% reduction in serum M protein plus urine M protein level less than 100 milligram/24 hour. CR=normal free light chain (FLC) ratio and absence of phenotypically aberrant plasma cells (PC) in bone marrow with a minimum of 3000 total PC analyzed by multiparametric flow cytometry; Complete response (CR) negative immunofixation on the serum and urine and, disappearance of any soft tissue plasmocytomas and <5% plasma cells in bone marrow.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Percentage of participants|||Number
2694560|NCT01286077|Secondary|Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)|Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter [mm]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.|Baseline up to end of study (approximately 4 years 7 months)|FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.|||millimeter (mm)||Standard Deviation|Mean
2694561|NCT01286077|Secondary|Overall Survival|Overall survival defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY to date of death|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Months||Standard Error|Median
2694562|NCT01286077|Secondary|Karnofsky Performance Status|"The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is perfect health and 0 is death."|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."|||Units on a scale||Standard Deviation|Mean
2694563|NCT01286077|Secondary|Change From Baseline in Spine T-score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."|||T score||Standard Deviation|Mean
2694564|NCT01286077|Secondary|Appearance of New Bone Lesions Compared to Baseline|Appearance of new bone lesions assessed by skeletal survey compared to baseline|Baseline up to end of study (approximately 4 years 7 months)|Data could not be summarised statistically due to insufficient data at End of treatment.|||subjects|||Number
2694565|NCT01286077|Secondary|Number of Patients With Skeletal Events|Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||patients|||Number
2694566|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)|Bone markers Dickkopf homolog 1 (DKK-1) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."|||Picomole per liter||Standard Deviation|Mean
2694567|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)|Change from Baseline in Biochemical Bone Markers: CTX-I was assessed|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."|||Nanogram per liter||Standard Deviation|Mean
2694568|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)|Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."|||Microgram per liter||Standard Deviation|Mean
2694569|NCT01286077|Secondary|Progression Free Survival|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to end of study (approximately 4 years 7 months)|Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.|||Months||Standard Error|Mean
2694570|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:8 patients in the bortezomib group and 8 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter|||g/mm2||Standard Deviation|Mean
2694571|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter|||g/mm2||Standard Deviation|Mean
2694572|NCT01286012|Secondary|Comparison of Iron Delivery to the Erythron From Baseline to End of Treatment Between the Treatment Groups.|Iron delivery to the erythron was estimated by Hgb generation in response to erythropoietin (ERI, calculated as ESA dose/Hgb). In addition, ERI was also divided by body weight in kilograms to obtain a modified ERI (ERI/kg).|36 weeks||||Units/kilogram/week/gram/liter||Standard Deviation|Mean
2694573|NCT01286012|Secondary|The Amount of Supplemental Intravenous (IV) Iron Needed During Study Participation.|The absolute amount of IV iron administered to subjects in each treatment group was divided by the number of weeks on study and the number of subjects per treatment group such that the mean dose of IV iron (mg) per week per subject (for the entire treatment group) was calculated.|36 weeks||||mg per week per subject||Standard Deviation|Mean
2694574|NCT01286012|Secondary|Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL.|The number of patients in each treatment group who had maintained their hemoglobin between 95 and 115 grams/liter at the end of treatment was quantified.|36 weeks||||Participants|||Count of Participants
2694575|NCT01286012|Secondary|The Distribution of Changes From Baseline in the Prescribed ESA Dose Between the Two Treatment Arms|The change from baseline in prescribed ESA dose at end-of-treatment was categorized as being greater than or equal to 25%, 10 to less than 25%, -10 to 10%, greater than -25 to -10% and less than or equal to -25%. The number of subjects in each treatment group that fit each category was compared.|ESA dose is monitored and recorded at each dialysis session for 36 weeks.||||Participants|||Count of Participants
2694576|NCT01286012|Primary|The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.|The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.|Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.|MITT population: Randomized subjects who received at least one dose of study drug and also received ESA during the treatment period.|||Percent change||Standard Error|Least Squares Mean
2694577|NCT01285960|Primary|Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment|The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%|From treatment to 1-month post-treatment|Per protocol 2 subjects receiving < 10 sonications were excluded from the safety sample size of 108 for an primary safety analysis sample size of 106.|||Percentage of participants||95% Confidence Interval|Number
2694578|NCT01285947|Primary|Pain Rated by Subjects|"The mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments.~Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score."|3 hours for all treatments in one visit||||Units on a scale||Standard Deviation|Mean
2694579|NCT01285908|Secondary|Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)|Plasma levels of dihydroxyphenylglycol are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||nmol/L||Standard Deviation|Mean
2694580|NCT01285908|Secondary|Arterial Plasma Levels of Norepinephrine|Plasma levels of norepinephrine are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||nmol/L||Standard Deviation|Mean
2694581|NCT01285908|Secondary|Total Peripheral Resistance|The extent to which norepinephrine infusion affected total peripheral resistance, by comparison of total peripheral resistance at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mmHg/(min/L)||Standard Deviation|Mean
2694582|NCT01285908|Secondary|Cardiac Output|The extent to which norepinephrine infusion affects cardiac output, by comparison of cardiac output at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||L/min||Standard Deviation|Mean
2694583|NCT01285908|Primary|Blood Pressure (Mean)|The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mm Hg||Standard Deviation|Mean
2694584|NCT01285908|Secondary|Cardiac Stroke Volume|The extent to which norepinephrine infusion affects cardiac stroke volume, by comparison of cardiac stroke volume at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mL||Standard Deviation|Mean
2694585|NCT01285908|Secondary|Heart Rate|The extent to which norepinephrine infusion affects heart rate, by comparison of beat-to-beat heart rate at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||bpm||Standard Deviation|Mean
2694586|NCT01285908|Primary|Blood Pressure (Diastolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mm Hg||Standard Deviation|Mean
2694587|NCT01285908|Primary|Blood Pressure (Systolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mm Hg||Standard Deviation|Mean
2694588|NCT01285843|Secondary|Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.|Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.|6 months, 1 year||||participants|||Number
2702553|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 6 Week Follow-up|Incontinence- involuntary leakage of urine|Baseline to 6 weeks||||number of episodes||Standard Deviation|Mean
2694589|NCT01285843|Secondary|Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.|The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.|6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HAAS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).|||units on a scale (0-18)||Standard Deviation|Mean
2694590|NCT01285843|Secondary|Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score|"The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity.~The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative."|6 weeks, 6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HHS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).|||units on a scale (0-100)||Standard Deviation|Mean
2694591|NCT01285843|Primary|Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.||0-12 months||||g/cm2||Standard Deviation|Mean
2694592|NCT01285791|Secondary|Change in Glucose and Triglyceride Blood Level|finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.|18 months|||||||
2694593|NCT01285791|Primary|Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.|morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .|18 months||||visceral fat reduction in centimeters||Standard Error|Mean
2694594|NCT01285713|Primary|Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis|Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.|4 hours||||mmol/L||Standard Deviation|Mean
2694595|NCT01285635|Secondary|Median Progression Free Survival in Months|Progression is defined, by RECIST (Response Evaluation Criteria in Solid Tumors), as at least a 20% increase in the sum of the longest diameter of target lesions.|3 Years||||months||95% Confidence Interval|Median
2694596|NCT01285635|Secondary|Median Overall Survival in Months||3 Years||||months||95% Confidence Interval|Median
2694597|NCT01285635|Secondary|Incidence of Grade 3 and 4 Toxicities by Arm|Measure the grade III/IV toxicities experienced by patients with advanced, locally recurrent, or metastatic SCCHN|3 years||||participants|||Number
2694598|NCT01285635|Secondary|Median Duration of Response For All Groups Combined||3 years|All patients on study|||months||Full Range|Median
2694599|NCT01285635|Primary|Number of Patients With a Complete Response (CR) and Partial Response (PR)|The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.|12 months||||Patients|||Number
2694600|NCT01285609|Secondary|Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy|||months||95% Confidence Interval|Median
2694601|NCT01285609|Secondary|Overall Survival (OS) in All Randomized Participants at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)|All randomized participants|||months||95% Confidence Interval|Median
2694653|NCT01285401|Post-Hoc|Percentage of Subjects With Disease Activity Free Status (Alternate Definition) at Week 48|Disease activity free (DAF) status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no confirmed expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions. Confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694602|NCT01285609|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy|||months||95% Confidence Interval|Median
2694603|NCT01285518|Secondary|Volume of Distribution at Steady State (Vss) of PF-05231023|Vss was calculated by dividing the area under the first moment curve from time zero to infinity [AUMC(0-∞)] with the product of area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||L||Standard Deviation|Geometric Mean
2694604|NCT01285518|Secondary|Back-extrapolated Concentration at Time Zero (C0) of PF-05231023|C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than [<] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.|0.25 H post-dose to Bo on Day 1|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. C0 was calculated for cohort 1 (group: PF-05231023 0.5 mg) and 2 (group: PF-05231023 1.5 mg) only as per planned analysis, hence results for the same reported.|||ng/mL||Standard Deviation|Geometric Mean
2694605|NCT01285518|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||ng*hr/ml||Standard Deviation|Geometric Mean
2694606|NCT01285518|Secondary|Apparent Volume of Distribution (Vz) of PF-05231023|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||Liter||Standard Deviation|Geometric Mean
2694607|NCT01285518|Secondary|Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.|Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||liter per hour||Standard Deviation|Geometric Mean
2694608|NCT01285518|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||hour||Standard Deviation|Mean
2694609|NCT01285518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ng/mL||Standard Deviation|Geometric Mean
2694610|NCT01285518|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
2694611|NCT01285518|Secondary|Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023|"Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).~Participants who received PF-05231023 with C-terminal and N-terminal AUClast were reported."|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ng*hour[H]/mL||Standard Deviation|Geometric Mean
2694612|NCT01285518|Primary|Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry|Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned.|From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.||||||
2694613|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2694614|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
2694615|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
2694616|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
2694617|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
2694618|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2694619|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2694620|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. Here,'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2694621|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||nanogram per millileter (ng/mL)||Standard Deviation|Mean
2694622|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||nanogram per millileter (ng/mL)||Standard Deviation|Mean
2694623|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||ng/mL||Standard Deviation|Mean
2694624|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2694625|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 34|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 34|Safety population. No participant was involved in groups: PF-05231023 0.5,1.5,5,15,50,100 mg and placebo for this time point of outcome measure, hence results were not reported for the same.'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
2694626|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 22|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 22|Safety population included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
2694627|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 15|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 15|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
2694628|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 8|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 8|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.|||participants|||Number
2694629|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 1|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 1|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.|||participants|||Number
2694630|NCT01285518|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2694631|NCT01285518|Primary|Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels|Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).|Day 0 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2694632|NCT01285518|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).|Screening up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2694633|NCT01285518|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Day 1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2694634|NCT01285518|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2694654|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48||Baseline, 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||millimeter^3 (mm^3)||Standard Deviation|Mean
2694635|NCT01285518|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2694636|NCT01285518|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.|Day -1 up to Day 22|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.||||||
2694637|NCT01285492|Secondary|Change in Pre-dose Forced Vital Capacity (FVC) From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.|||Litres||Standard Deviation|Mean
2694638|NCT01285492|Secondary|Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.|||Litres||Standard Deviation|Mean
2694639|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period|Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
2694640|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
2694641|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
2694642|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
2694643|NCT01285492|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death|An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
2694644|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694645|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694646|NCT01285427|Primary|SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694647|NCT01285427|Primary|SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694648|NCT01285427|Primary|SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2694649|NCT01285427|Primary|SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
2702648|NCT01225835|Secondary|Estradiol (E2) Levels on Day of hCG Administration||approximately day 10|Per protocol set. Five participants from each treatment arm were missing blood samples.|||ng/ml||Standard Deviation|Mean
2694655|NCT01285401|Secondary|Percentage of Subjects Treated With Glucocorticoids Due to Relapses|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694656|NCT01285401|Secondary|Total Number of Reported Relapses at All Time Points up to 48 Weeks|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||number of relapse per subject||Standard Deviation|Mean
2694657|NCT01285401|Secondary|Annualized Relapse Rate at Week 48|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||relapse per year||Standard Deviation|Mean
2694658|NCT01285401|Secondary|Number of Subjects With Relapse|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||subjects|||Number
2694659|NCT01285401|Secondary|Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here “N” signifies number of subjects analyzed for respective outcome measure (here in the subgroup of subjects having new or enlarging T2 lesions).|||percentage of new T1 hypointense lesions||Standard Deviation|Mean
2694660|NCT01285401|Secondary|Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694661|NCT01285401|Secondary|Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694662|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)||Baseline, 48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subjects analyzed for respective outcome measure."|||millimeter^3 (mm^3)||Standard Deviation|Mean
2694663|NCT01285401|Secondary|Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||lesions per subject per scan||Standard Deviation|Mean
2694664|NCT01285401|Secondary|Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||lesions per subject per scan||Standard Deviation|Mean
2694665|NCT01285401|Secondary|Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48||48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subject analyzed for respective outcome measure."|||lesions per subject per scan||Standard Deviation|Mean
2694666|NCT01285401|Secondary|Number od Subjects With Confirmed EDSS Progression|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Baseline upto 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||subjects|||Number
2694764|NCT01285076|Secondary|Number of Adherence Days on the Self-reported Adherence Questionnaire|The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence).|7 days (during the 7-day period prior to the encounter visit)|All enrolled participants.|||Days||Standard Deviation|Mean
2694667|NCT01285401|Secondary|Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694668|NCT01285401|Secondary|Percentage of Relapse-free Subjects at Week 48|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694669|NCT01285401|Primary|Percentage of Subjects With Disease Activity Free Status up to Week 48|Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.|Up to Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
2694670|NCT01285349|Secondary|Number of Participants With Biologically Confirmed STIs (i.e., Chlamydia, Gonorrhea, and Trichomoniasis)||past 12 months||||participants|||Number
2694671|NCT01285349|Primary|Number of Unprotected Acts of Intercourse||90 days||||# of unprotected sex acts at 12 months||Standard Deviation|Mean
2694672|NCT01285323|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion.|Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52|Safety analysis set|||participants|||Number
2694673|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse (high): >100 and increase of >= 30 beats/minute~Sitting systolic blood pressure (low): <90 and decrease of >= 30 mmHg~Sitting systolic blood pressure (high): >160 and increase of >= 30 mmHg~Sitting diastolic blood pressure (low): <50 and decrease of >=12 mmHg (if 12-17 years old: <55 and decrease of >=12 mmHg 0~Sitting diastolic blood pressure (high): >100 and increase of >=12 mmHg~Respiratory rate (low): <6 breaths/minute~Respiratory rate (high): >24 and increase of >=10 breaths/minute~Body temperature (low): <35.8° Celsius~Body temperature (high): >=38.1 and increase of >=1.1° Celsius"|Week 4 to Week 52|Safety analysis set including participants who contributed data to the analysis|||participants|||Number
2694674|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Urate: M>=625, F>=506 μmol/L~Aspartate aminotransferase (AST): >=3*upper limit of normal (ULN)~Alanine aminotransferase (ALT): >=3*ULN~GGT = gamma-glutamyl transpeptidase: >= 3*ULN~Total bilirubin: >=34.2 μmol/L~White blood cells (low): <=3.0*10^9/L~White blood cells (high): >=20*10^9/L~Hemoglobin (age >=18 years): M<=115, F<=95 g/dL~Hematocrit (age >=18 years): M<0.37, F<0.32 L/L~Eosinophils/leukocytes: >=10.0%~Platelets: <=75*10^9/L~Neutrophils: <=1.0*10^9/L~Urinalysis: blood, ketones, glucose, and protein: >=2 unit increase from baseline"|Week 4 to Week 52|Safety analysis set, including participants who contributed to the analysis|||participants|||Number
2694675|NCT01285323|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.~Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.|||CAEs in 52 weeks||95% Confidence Interval|Mean
2694676|NCT01285323|Secondary|Participants With Treatment-Emergent Adverse Events TEAE)|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set|||participants|||Number
2694765|NCT01285076|Secondary|Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life.|1 day (the day of the encounter visit)|All enrolled participants.|||Score on a scale||Standard Deviation|Mean
2694677|NCT01285323|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded.~The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set including patients who contributed at least once to the analysis.|||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
2694678|NCT01285323|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set including patients who contributed at least once to the analysis.|||SABA puffs per day||Standard Error|Least Squares Mean
2694679|NCT01285323|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.~The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2694680|NCT01285323|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 526 (longest treatment time plus 2 weeks)|Randomized set|||weeks||95% Confidence Interval|Median
2694681|NCT01285323|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2694682|NCT01285323|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of participants with assessments at each timepoint.|||units on a scale||Standard Error|Least Squares Mean
2694690|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694683|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well.~Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Includes participants who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
2694684|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.~Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Week 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Number analyzed reflects participants with both baseline and Week 16 assessments.|||liters||Standard Error|Least Squares Mean
2694685|NCT01285323|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.|||CAEs in 52 weeks||95% Confidence Interval|Mean
2694686|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Year 2|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694687|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694688|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Year 2|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694689|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Year 2|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694691|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694831|NCT01284114|Primary|The Change of BNP|Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6month|We analyzed all patients who completed study.|||pg/ml||Standard Deviation|Mean
2694692|NCT01285310|Secondary|Percentage Change From Baseline in the Individual American College of Rheumatology Components at Year 2|"The Individual ACR Components were defined as follows:~Tender Joint Count (out of 68 joints)~Swollen Joint Count (out of 66 joints)~Subject Assessment of Pain (0 to 100 mm VAS)~Subject Global Assessment of Disease Activity (0 to 100 mm VAS)~Physician Global Assessment of Disease Activity (0 to 100 mm VAS)~HAQ-DI Score~Acute Phase Reactant High Sensitivity C-Reactive Protein (hsCRP, mg/dL) Erythrocyte Sedimentation Rate (ESR)~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694693|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Year 2|"The DAS 28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's global assessment of disease activity (SGA ). A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694694|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694695|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694696|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Year 2|"The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694697|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694698|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Year 2|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein.~The study was terminated before the 2-year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
2694722|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2694699|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 52|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2694700|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
2694701|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 52|Apremilast participants as randomized/transitioned (AAR Population); population consists of all participants who were randomized or transitioned to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2694702|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 52|Apremilast participants as randomized during the apremilast exposure period.|||percentage of participants||95% Confidence Interval|Number
2694703|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
2694704|NCT01285310|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2694705|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2694706|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 52|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2696459|NCT01270503|Secondary|Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.|||Participants|||Number
2694707|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2694708|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 52|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2694709|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 52|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2694710|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 52|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2694711|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 52|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included..|||percent change||Standard Deviation|Mean
2694712|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 52|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
2694713|NCT01285310|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's global assessment of disease activity (SGA).~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2694714|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS),, where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
2694760|NCT01285076|Secondary|Fear of Weight Gain Questionnaire|Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt).|1 year (during the 12-month period prior to the encounter visit)|The population analyzed only includes participants with available data.|||Percentage of participants|||Number
2696460|NCT01270503|Primary|Safety Overview Within 30 Days in Participants Vaccinated With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.|||Participants|||Number
2694715|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2694716|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2694717|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2694718|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 52|"The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.~Reporting Groups"|||percentage of participants||95% Confidence Interval|Number
2694719|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 24|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 24|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2694720|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percentage of participants|||Number
2694721|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2694832|NCT01284114|Primary|The Change of Heart Function Confirmed by Echocardiograph|Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month. Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6 month|We analyzed participants who copmleted this study|||% of stroke vulume/enddiastolic volume||Standard Deviation|Mean
2694723|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694724|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 24|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694725|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694726|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 24|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694727|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 24|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694728|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 24|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694729|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 24|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694730|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 24|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
2694761|NCT01285076|Secondary|Experience of Weight Gain Questionnaire|Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded.|1 year (during the 12-month period prior to the encounter visit)|The population analyzed includes only participants with available data.|||Percentage of participants|||Number
2694731|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) Using CRP at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's Global Assessment of Disease Activity.~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2694732|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percentage of participants|||Number
2694733|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2694734|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2694735|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.|||percentage of participants|||Number
2694736|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.|||percentage of participants|||Number
2694762|NCT01285076|Secondary|Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II|This questionnaire measures a diabetic participant's fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most).|6 months (during the 6-month period prior to the encounter visit)|The population analyzed includes only participants with available data.|||Score on a scale||Standard Deviation|Mean
2694833|NCT01284114|Primary|The Change of Blood Pressure|The change of systolic blood pressure and diastolic blood pressure|baseline and 6 month|We analyzed all patients who completed study.|||mmHg||Standard Deviation|Mean
2694737|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 16|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 16.|||percent of participants|||Number
2694738|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2694739|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 16|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2694740|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percentage of participants|||Number
2694741|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
2694742|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2694743|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 16|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2694744|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 16|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2706411|NCT01196442|Primary|Change in Pain Score From Day 1 to Day 10|"Change in Brief Pain Inventory (Now)Scale~1 (none) to 5 (complete interference)"|From day 1 to day 10||||units on a scale||Standard Deviation|Mean
2694745|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2694746|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 16|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Error|Least Squares Mean
2694747|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 16|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2694748|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 16|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2694749|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 16|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2694750|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 16|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2694751|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's global assessment of disease activity (SGA )~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2694752|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||percentage of participants|||Number
2694763|NCT01285076|Secondary|Experience of Low Blood Sugar (Hypoglycemia) Questionnaire|The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale.|6 months (during the 6-month period prior to the encounter visit)|All enrolled participants.|||Participants|||Number
2706449|NCT01196104|Secondary|Baseline Forced Expiratory Volume in 1 Second (FEV1)|Baseline FEV1|Baseline|Safety Population|||L||Standard Deviation|Mean
2694753|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2694754|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2694755|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Deviation|Mean
2694756|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2694757|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2694758|NCT01285310|Primary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2694759|NCT01285076|Secondary|Self-reported Barrier Questionnaire|The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month.|30 days (during the 30-day period prior to the encounter visit)|All enrolled participants.|||Participants|||Number
2694883|NCT01283555|Secondary|Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator|"Participants were asked if the cost of the applicator would influence their choice of applicator.~Response categories were yes, no, and maybe."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694766|NCT01285076|Secondary|Score on the Quality of Life (EQ-5D) Questionnaire|The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best).|1 day (the day of the encounter visit)|The population analyzed includes only participants with available data.|||Score on a scale||Standard Deviation|Mean
2694767|NCT01285076|Primary|Number of Participants With Hypoglycemic Episodes|Participants self-reported hypoglycemic (low blood sugar) episodes.|6 months|All enrolled participants.|||participants|||Number
2694768|NCT01285076|Primary|Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%|HbA1c is measured as a percent.|6 months|The population analyzed includes only participants with available data.|||participants|||Number
2694769|NCT01285050|Primary|HCV RNA|HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.|48 hours after interferon administration||||log IU/ml||Inter-Quartile Range|Median
2694770|NCT01285024|Secondary|Total Hemoglobin Level Change|Total hemoglobin level change from preop to postoperative discharge.|day of surgery - 1 week postoperative||||g/dL||Standard Deviation|Mean
2694771|NCT01285024|Primary|Transfusion Requirement|Measure Title: Units of transfusion required|intraoperative - 1 week postoperative||||units||Standard Deviation|Mean
2694772|NCT01284959|Secondary|Assessment of Cognitive Functioning-3|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included Wisconsin Card-Sorting Test (WCST). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.~Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Trials to complete first category trials is 0, Maximum is 128 and minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after th"|baseline and 50hr after third medication||||trials||Standard Deviation|Mean
2694773|NCT01284959|Secondary|Assessment of Cognitive Functioning-2|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included the Stroop test, Trail-Making Test B (TMT B). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications Minimum of Stroop test is 0, no maximum limit, the higher number is worse outcome.~Minimum of Trail making test B is 0 and no maximum limit, the higher number is worse outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication||||milliseconds||Standard Deviation|Mean
2694774|NCT01284959|Secondary|Symptoms Assessment by Objective Rating Scales|SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) Minimum of NIDSS is -3, maximum of NIDSS is +3. '+' is better outcome, '-' is worse outcome. Minimum of SNAS-Global score is 0, Maximum of SNAS-Global score is 5 The higher number is worse outcome. The zeros are measured and Calcuated value. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication||||units on a scale||Standard Deviation|Mean
2694775|NCT01284959|Secondary|Assessment of Cognitive Functioning-1|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included a word fluency test. All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.~Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.~Minimum of Word-fluency test is 0 and no maximum value, the higher number is better outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication||||scores on a scale||Standard Deviation|Mean
2694776|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS is 0, Maximum is 10 Minimum of DIEPSS is 0, Maximum is 4 The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication||||units on a scale||Standard Deviation|Mean
2694777|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|"DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10.~VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication||||units on a scale||Standard Deviation|Mean
2694884|NCT01283555|Secondary|Number of Participants Reporting That Both Applicators Were Acceptable|"Participants were asked if both applicators were acceptable to them. Responses were either yes or no."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694778|NCT01284959|Primary|Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales|"SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total.~Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication||||units on a scale||Standard Deviation|Mean
2694779|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum Triglyceride Levels|A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||mmol/l||Standard Deviation|Mean
2694780|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio|A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||change in ratio||Standard Deviation|Mean
2694781|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels|A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||mmol/l||Standard Deviation|Mean
2694782|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels|A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||mmol/l||Standard Deviation|Mean
2694783|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels|A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||millimole (mmol)/l||Standard Deviation|Mean
2694784|NCT01284634|Primary|Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels|Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.|Baseline to EOT (Day 57) or Early Termination (ET)|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||percentage change||Standard Deviation|Mean
2694785|NCT01284621|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Tolerability|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From drug administration until end of washout period (36 days)|Treated set which included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
2694786|NCT01284621|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/Fss)|Apparent volume of distribution at steady-state during the terminal phase λz following an extravascular dose.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
2694787|NCT01284621|Secondary|Apparent Clearance After Extravascular Administration (CL/Fss)|Apparent clearance of the analyte in plasma after extravascular administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2694788|NCT01284621|Secondary|Mean Residence Time (MRTpo,ss)|Mean residence time of the analyte in the body after oral administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Geometric Coefficient of Variation|Geometric Mean
2694789|NCT01284621|Secondary|Terminal Half-life (T 1/2,ss)|Terminal half-life of the analyte in plasma at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Geometric Coefficient of Variation|Geometric Mean
2694790|NCT01284621|Secondary|Terminal Rate Constant (λz,ss)|Terminal rate constant in plasma at steady-state|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2694791|NCT01284621|Secondary|Time From Last Dosing to the Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Full Range|Median
2694792|NCT01284621|Secondary|Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|"Predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramiprilat.~Note, predose concentrations for ramipril were all below the limit of quantification (BLQ) and therefore the predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramipril was not analysed."|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2694793|NCT01284621|Secondary|Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|Predose concentration of the analyte in plasma prior to administration of the Nth dose, of empagliflozin.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2694794|NCT01284621|Primary|Total Ramiprilat: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramiprilat.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2694795|NCT01284621|Primary|Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramiprilat (active metabolite of ramipril).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2694796|NCT01284621|Primary|Total Ramipril: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2694797|NCT01284621|Primary|Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2694798|NCT01284621|Primary|Total Empa: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2706450|NCT01196104|Secondary|Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation||Baseline to Week 16|Safety Population|||Cough episodes|||Number
2694799|NCT01284621|Primary|Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2694800|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
2694801|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
2694802|NCT01284517|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
2694803|NCT01284504|Secondary|Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.||30 days|One patient was accrued and withdrawn after signing consent; none were treated.||||||
2694804|NCT01284504|Primary|Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.||30 days|One patient was accrued and withdrawn after signing consent; none were treated.||||||
2694805|NCT01284504|Primary|Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling||2 years|One patient was accrued and withdrawn after signing consent; none were treated.||||||
2694806|NCT01284491|Primary|Scar Quality|The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.|0-18 months following breast reduction surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2694807|NCT01284426|Primary|Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.|"Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria.~Description in details:~Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported."|6 years|Children 4-15 years old with chronic urticaria|||percentage of participants|||Number
2694808|NCT01284361|Secondary|Assessment of Ease of Use Characteristics|"Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the top two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree."|1 week|82 self-catheterizing wheelchair-using men|||percentage of participants|||Number
2694809|NCT01284361|Primary|Percentage of Participants|Percentage of participants that preferred the 40 cm catheter|1 week||||percentage of participants|||Number
2694810|NCT01284335|Secondary|PK: Area Under the Curve Albumin (AUCalb)|Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.|Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.|All participants who received at least one dose of study drug Tasisulam and had evaluable PK data.|||micrograms*hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2694811|NCT01284335|Secondary|Number of Participants With a Clinically Significant Effects|Clinically significant effects are reported if a Grade 3 or higher treatment emergent adverse event (TEAE) and observed in ≥10% of participants or a toxicity possibly related to study drug based on Common Terminology Criteria for Adverse Events (CTCAE). A summary of other nonserious AEs and all SAEs, regardless of causality is located in the Reported Adverse Event section.|Baseline to Study Completion (Up to 2 years)|All participants who received at least one dose of study drug Tasisulam and experienced a Grade 3 or higher TEAE or drug toxicity possibly related to study drug.|||Participants|||Count of Participants
2694812|NCT01284335|Secondary|Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)|Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Baseline to Study Completion (Up to 2 years)|All participants who received study drug Tasisulam and had CR or PR tumor response at dose confirmation phase.|||percentage of participants||90% Confidence Interval|Number
2694813|NCT01284335|Secondary|Pharmacokinetic (PK): Concentration Maximum (Cmax)|Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.|Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.|All participants who received at least one dose of study drug Tasisulam and had evaluable PK data|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2694814|NCT01284335|Primary|Number of Participants With Dose-Limiting Toxicities Cycle 1|A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.|Baseline to Cycle 1 (Up to Day 28)|All participants who received at least one dose of study drug Tasisulam in dose escalation phase and experienced a dose-limiting toxicity.|||Participants|||Count of Participants
2694815|NCT01284296|Primary|Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.||A minimum of 2-4 differences recorded approximately hourly during surgery||||percentage of hemoglobin readings|Participants||Number
2694816|NCT01284244|Primary|A 50% Reduction in Pad Test Weight|"A pad test is an objective measure of urine loss. With a full bladder, while wearing a pad, the participant completes five repetitions of the following physical activities: coughing, step climbing, heel bounce, standing from a sitting position and walking 50 yards. The weight of the pad is then determined.~The primary outcome variable will be the achievement of a 50% reduction in the pad weight before and after device placement. This figure is obtained from the study by Farrell et al, where pad weight decreased from 20 grams to 9 grams with the use of the Uresta device."|Immediately after device placement (short term).||||Participants|||Count of Participants
2694817|NCT01284140|Secondary|Delirium|The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups.|Day 3|Subjects still on study in the ICU on Day 3.|||Participants|||Count of Participants
2694818|NCT01284140|Secondary|Spectral Edge Frequency 95%|The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups.|Day 2|Polysomnography was not conducted on any participants due to logistical constraints.||||||
2694819|NCT01284140|Secondary|Circadian Amplitude|The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.|Day 3|Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.|||percent of 24-hour mean 6-sulfatoxymelat||Standard Deviation|Mean
2694820|NCT01284140|Secondary|Normal Circadian Timing|The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups.|Day 3|Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.|||Participants|||Count of Participants
2694821|NCT01284140|Primary|Circadian Timing|The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1).|Day 1 to Day 3|Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.|||hours|||Number
2694822|NCT01284127|Secondary|Number of Participants With MRI of the Brain and Spinal Cord Showing Changes in Hemosiderin Deposition|MRI of the brain and spinal cord without contrast to monitor for changes in hemosiderin deposition in terms of worsening or improvement.|Baseline, At the end of the 2-year period|All participants with follow up MRIs (16) were evaluated.|||Participants|||Count of Participants
2694823|NCT01284127|Primary|Number of Participants Who Show Stability, Improvement or Decline in Self Reported Bowel/Bladder Function|Number of participants who show stability, improvement or decline in self reported bowel/bladder function.|At the end of the 2-year period||||Participants|||Count of Participants
2694824|NCT01284127|Primary|Number of Participants Who Show Stability, Improvement or Decline in Self Reported Fine Motor Function|Number of participants who show stability, improvement or decline in self reported fine motor function.|At the end of the 2-year period||||Participants|||Count of Participants
2694825|NCT01284127|Primary|Number of Participants Who Show Stability, Improvement or Decline in Self Reported Walking|Number of participants who show stability, improvement or decline in self reported walking.|At the end of the 2-year period||||Participants|||Count of Participants
2694826|NCT01284127|Primary|Number of Participants Who Show Stability, Improvement or Decline in Self Reported Coordination|Number of participants who show stability, improvement or decline in self reported coordination.|At the end of the 2-year period||||Participants|||Count of Participants
2694827|NCT01284127|Primary|Number of Participants Who Show Stability, Improvement or Decline in Self Reported Hearing|Number of participants who show stability, improvement or decline in self reported hearing.|At the end of the 2-year period||||Participants|||Count of Participants
2694828|NCT01284114|Primary|The Change of Urine Albumin/ Creatinine Ratio (UACR).|The UACR was measured at baseline, Week12 and Week24|baseline and 6 months|We analyzed all patients who completed this study.|||mg/g||Standard Deviation|Mean
2694829|NCT01284114|Primary|The Change of eGFR|eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73 m2) = 194 × age-0.287 × serum creatinine-1.094 (multiplied by 0.739 for females).|baseline and 6 month|We analyzed all patients who completed study.|||mL/min/1.73m2||Standard Deviation|Mean
2694830|NCT01284114|Secondary|The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM||6 months|||||||
2706451|NCT01196104|Secondary|Number of Single Coughing Episodes|Total number of times patients coughed only once|Baseline to Week 16|Safety Population|||Cough episodes|||Number
2694834|NCT01284062|Secondary|Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||participants|||Number
2694835|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Rectal Bleeding at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||participants|||Number
2694836|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Stool Frequency at Week 14|Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||participants|||Number
2694837|NCT01284062|Other Pre-specified|Change From Baseline in Total Mayo Score at Week 14|The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||unit on a scale||95% Confidence Interval|Least Squares Mean
2694838|NCT01284062|Other Pre-specified|Clinical Remission Rate at Week 14|Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||percentage of participants||95% Confidence Interval|Number
2694839|NCT01284062|Other Pre-specified|Clinical Response Rate at Week 14|Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||percentage of participants||95% Confidence Interval|Number
2694840|NCT01284062|Secondary|Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody|Neutralizing antibody was not analyzed as no participant had positive ADA samples.|Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.|||participants|||Number
2694841|NCT01284062|Secondary|Number of Participants Who Discontinued From the Study Due to Adverse Events||Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2694842|NCT01284062|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.|Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2694843|NCT01284062|Secondary|Total Interleukin-13 (IL-13) Level||Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.|||picogram/milliliter||Standard Deviation|Mean
2694844|NCT01284062|Secondary|Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12|The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.|Baseline, Week 2, 4, 8, 12|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.|||fold change||95% Confidence Interval|Least Squares Mean
2694845|NCT01284062|Secondary|Volume of Distribution (Vz) for Anrukinzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||liters||Standard Deviation|Mean
2694846|NCT01284062|Secondary|Systemic Clearance (CL) for Anrukinzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||liters/day||Standard Deviation|Mean
2694847|NCT01284062|Secondary|Plasma Decay Half-Life (t1/2) for Anrukinzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||hours||Standard Deviation|Mean
2694848|NCT01284062|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab|Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.|Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2694849|NCT01284062|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab|Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” signifies participants in PK population; n signifies evaluable participants at specified time point."|||ng/mL||Standard Deviation|Mean
2694850|NCT01284062|Secondary|Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab|Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable pharmacokinetic (PK) results were included in PK population. PK samples with time deviation greater than (>) 20 percent (%) from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” = participants in PK population; n = evaluable participants at specified time point."|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2694851|NCT01284062|Primary|Fold Change From Baseline in Fecal Calprotectin at Week 14|The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.|Baseline, Week 14|Modified Intent to Treat (mITT: all randomized participants who received greater than or equal to [>=] 1 dose study drug); Data as Observed (DAO: all mITT participants with all data needed for calculation of specified endpoint). “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||fold change||95% Confidence Interval|Least Squares Mean
2694852|NCT01283971|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Discontinuation Due to AEs and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|32 weeks|Safety Population included all participants who received study drug and who had at least 1 post-dose safety assessment.|||Participants|||Number
2694853|NCT01283971|Secondary|Change From Baseline in Hemoglobin at Week 24|Blood was collected at Baseline and Week 24. The samples were sent to a central laboratory for Hemoglobin analysis reported in gram/deciliter (g/dL). A positive number change from Baseline (a higher hemoglobin level compared to Baseline) indicated improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with hemoglobin data available at Baseline and Week 24.|||g/dL||Standard Deviation|Mean
2694862|NCT01283971|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 24|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
2694854|NCT01283971|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 24|RAPID3 is a patient self reported assessment that combines the HAQ-DI [20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions answered on a 4-point scale where 0=without any difficulty to 3=unable to do} converted to a score of 0-10, the Patients Assessment of Pain [Over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain] converted to a score of 0-10 and the Patient's Global Assessment of Disease Activity [over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity] converted to a score of 0-10. The 3 individual scales are summed for a raw score of 0-30 which is divided by 3 to achieve a total possible adjusted score of 0-10. A negative change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2694855|NCT01283971|Secondary|Change From Baseline in Quality of Life Short Form (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2694856|NCT01283971|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
2694857|NCT01283971|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
2694858|NCT01283971|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeter/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||mm/hr||Standard Deviation|Mean
2694859|NCT01283971|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 24|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The concentration of CRP was measured in milligram/liter (mg/L). A reduction in the level is considered an improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||mg/L||Standard Deviation|Mean
2694860|NCT01283971|Secondary|Change From Baseline in the Physician Global Assessment of Disease Activity VAS at Week 24|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
2694861|NCT01283971|Secondary|Change From Baseline in the Patient Global Assessment of Disease Activity VAS at Week 24|"The patient's global assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
2696964|NCT01265550|Secondary|Number of Enrolled Participants With Globus||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for globus|||Participants|||Count of Participants
2694863|NCT01283971|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation carried forward was used to impute missing tender joint counts.|||Joint count||Standard Deviation|Mean
2694864|NCT01283971|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation was used to impute missing swollen joint counts.|||Joint count||Standard Deviation|Mean
2694865|NCT01283971|Secondary|Change From Baseline in DAS28 Score at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.|||Score on a scale||Standard Deviation|Mean
2694866|NCT01283971|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. LDAS is defined as DAS28 ≤3.2.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.|||Percentage of participants|||Number
2694867|NCT01283971|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) DAS28 Responses at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total score ranges from 0 (best) to 10 (worst). A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other EULAR components were used as observed.|||Percentage of participants|||Number
2694868|NCT01283971|Secondary|Percentage of Participants With ACR70 Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
2694869|NCT01283971|Secondary|Percentage of Participants With ACR50 Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
2694881|NCT01283555|Secondary|Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694882|NCT01283555|Primary|Number of Colposcopic Findings (Baseline and After One Week of Product Use)|Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator|7 days|The number of participants for analysis was determined by counting the number of participants with colposcopic findings and baseline and after one week of product use.|||colposcopic findings|Participants||Number
2694870|NCT01283971|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
2694871|NCT01283971|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. DAS28 Remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
2694872|NCT01283581|Secondary|Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population|The success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.|Follow-up (Day 14 ± 1)|Microbiological ITT Population (MITT)|||Participants|||Count of Participants
2694873|NCT01283581|Secondary|Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population|Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.|Follow-up (Day 14 ± 1)|Microbiologically Evaluable (ME) Population - MRSA Subjects|||Participants|||Count of Participants
2694874|NCT01283581|Secondary|Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)|Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.|Follow-up (Day 14 ± 1)|Microbiologically Evaluable (ME) Population - All Subjects|||Participants|||Count of Participants
2694875|NCT01283581|Secondary|The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)|CRP Levels (g/m3) were analyzed from blood samples collected from subjects at Baseline and various time points throughout the study. Change in baseline values were analyzed using an analysis of covariance (ANCOVA) model with treatment, infection category, and prior antimicrobial therapy as fixed effects and the baseline measure as the covariate.|Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)|Only subjects from ITT population with CRP levels evaluated were included in outcome measure analysis.|||g/m3||Standard Deviation|Mean
2694876|NCT01283581|Secondary|Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid|Blood samples for pharmacokinetic analyses were drawn from all subjects on Day 3 (± 1 day) of treatment within 2 hours before the first study drug infusion and at 1, 2, 3, 5, and 12 hours (ie, immediately before the second dose) after the start of the first study drug infusion. An analytical, validated method was used to analyze samples and determine human plasma concentrations. The primary pharmacokinetic parameter calculated was area under the plasma concentration - time curve from time 0 extrapolated to infinity (AUCinf, ug*h/mL).|Through Day 3 (± 1 day)|AUCinf (ug*h/mL) for delafloxacin, linezolid, and vancomycin are presented only for those subjects with PK samples collected.|||ug*h/mL||Standard Deviation|Mean
2694877|NCT01283581|Secondary|Erythema Clinical Success|The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.|48 - 72 hours|ITT (intent-to-treat) population, defined as all subjects who were randomized.|||Participants|||Number
2694878|NCT01283581|Primary|Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up|The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.|Follow-up (Day 14 ± 1)|ITT (intent-to-treat) population, defined as all subjects who were randomized.|||Participants|||Number
2694879|NCT01283555|Secondary|Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention|"Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694880|NCT01283555|Secondary|Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694886|NCT01283555|Secondary|Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort|"Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were yes and no. If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694887|NCT01283555|Secondary|Number of Participants Reporting That Applicator Was Comfortable to Use|"Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).~Response categories included comfortable, neutral, and uncomfortable."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694888|NCT01283555|Secondary|Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors|"Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.~Response categories included user-filled, prefilled, and same."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||responses|||Number
2694889|NCT01283555|Secondary|Number of Participants Reporting That the Gel Was Easy to Dispense|"Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694890|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Insert|"Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694891|NCT01283555|Secondary|Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly|"Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.~Response categories included plunger automatically stopped, the 'FULL' line was reached, and other.~Note: this question does not apply to the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis. Each participant could identify multiple reasons. As a result, the number of units analyzed is greater than the number of participants.|||participants|Participants||Number
2694892|NCT01283555|Secondary|Number of Respondents Reporting Confidence With Filling the User-filled Applicator|"Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.~Response categories included very confident, confident, and not confident.~(Note: this question does not apply to the prefilled applicator.)"|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694893|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Fill|"Participants were asked to describe the process of filling the user-filled applicator.~Response categories included easy, moderately difficult, and difficult.~Since ease of filling only applies to the user-filled applicator, this question was not applicable for the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
2694894|NCT01283555|Secondary|Dosing Accuracy (% of Target Dose Delivered)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||percent of target dose delivered|Participants||Number
2694895|NCT01283555|Secondary|Dosing Precision, 10% (Expressed Volume)|A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
2694896|NCT01283555|Secondary|Dosing Precision, 5% (Expressed Volume)|A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
2694897|NCT01283555|Secondary|Dosing Volume (Expressed Volume)|At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density.|3 dose delivery measurements during 1 week of product use|Per protocol, all participants were included in the analysis.|||ml|Participants|Standard Deviation|Mean
2694898|NCT01283555|Secondary|Filling Accuracy (% of Target Dose)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||% of target dose filled into applicator|Participants||Number
2694899|NCT01283555|Secondary|Filling Precision (10% Range)|A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
2694900|NCT01283555|Secondary|Filling Precision (5% Range)|A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
2694959|NCT01283282|Secondary|Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Week 12||||m/s||Standard Error|Mean
2694901|NCT01283555|Secondary|Filled Volume|At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||ml|Participants|Standard Deviation|Mean
2694902|NCT01283542|Secondary|Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)|Alpha subunit levels were determined at a central laboratory.|Baseline up to approximately Week 96|Evaluable participants had to have 50% reduction|||percentage of participants|||Number
2694903|NCT01283542|Secondary|Mean Alpha Subunit Levels in Main and Extension Phases (FAS)||Baseline and at weeks 12,24,48,72, 96||||ng/mL||Standard Deviation|Mean
2694904|NCT01283542|Secondary|Mean TSH Hormone Levels During Main and Extension Phases (FAS)|Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab|Baseline and at weeks 24, 48, 96|participants with evaluable data varied across visits|||µUI/mL||Standard Deviation|Mean
2694905|NCT01283542|Secondary|Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)|Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab|Baseline and at weeks 24, 48, 96|participants with evaluable data varied across visits|||ng/dL||Standard Deviation|Mean
2694906|NCT01283542|Secondary|Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)|Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab|Baseline and at weeks 24, 48, 96|participants with evaluable data varied across visits|||mUI/mL||Standard Deviation|Mean
2694907|NCT01283542|Secondary|Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)|Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab|Baseline and at weeks 24, 48, 96|number participants with evaluable data varied across visits|||µg/dL||Standard Deviation|Mean
2694908|NCT01283542|Secondary|Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)|Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab|Baseline and at weeks 24, 48, 96|participants with evaluable data varied across visits|||pg/mL||Standard Deviation|Mean
2694909|NCT01283542|Secondary|Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)|Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab|Baseline and at weeks 24, 48, 96|number of participants with evaluable data varied across visits|||ng/mL||Standard Deviation|Mean
2694910|NCT01283542|Secondary|Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)|The absence and presence of disease-related symptoms were reported by patients and recorded by the medical staff. Patients classified the symptoms according to a 5-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe|Baseline and at weeks 4, 12,24,48,72, 96|number of participants varied across visits|||percentage of participants|||Number
2694911|NCT01283542|Secondary|Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 48, 72, 96|number of participants with evaluable data varied across visits|||percentage of patients|||Number
2694912|NCT01283542|Secondary|Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 48, 72, 96|number of participants with evaluable data varied across visits|||percentage of patients|||Number
2694913|NCT01283542|Secondary|Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 4, 12, 24|number of participants with evaluable data varied across visits|||percentage of patients||95% Confidence Interval|Number
2694914|NCT01283542|Secondary|Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 4, 12, 24|number of participants with evaluable data varied across visits|||percentage of patients|||Number
2694915|NCT01283542|Secondary|Tumor Volume Percent Change From Baseline in Extension Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 48, 72, 96|number of participants with evaluable data varied across visits|||percent change||Standard Deviation|Mean
2694916|NCT01283542|Secondary|Tumor Volume Percent Change From Baseline in Main Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 4, 12, 24|number of participants with evaluable data varied across visits|||percent change||95% Confidence Interval|Mean
2694917|NCT01283542|Secondary|Tumor Volume Change From Baseline in Extension Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 48, 72, 96|number of participants with evaluable data varied across visits|||cm^3||Standard Deviation|Mean
2694918|NCT01283542|Secondary|Tumor Volume Change From Baseline in Main Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 4, 12, 24|number of participants with evaluable data varied across visits|||cm^3||95% Confidence Interval|Mean
2694919|NCT01283542|Secondary|Tumor Volume in Extension Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 48, 72, 96|number of participants with evaluable data varied across visits|||cm^3||Standard Deviation|Mean
2694920|NCT01283542|Secondary|Tumor Volume Main Phase (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.|baseline to week 4, 12, 24|number of participants with evaluable data varied across visits|||cm^3||Standard Deviation|Mean
2694921|NCT01283542|Primary|Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)|Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.|Baseline up to 24 weeks|Evaluable participants required tumor volume assessment at baseline and at week 24|||percentage of participants||95% Confidence Interval|Number
2694922|NCT01283516|Secondary|Secondary Pharmacokinetics (PK) Parameter: Racc|Racc is the accumulation ratio calculated using AUCtau values obtained from a dosing interval at steady-state divided by AUCtau at day 1 or PK run-in phase. AUCtau is the AUC calculated to the end of the dosing interval, tau. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Racc.|Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||unitless||Geometric Coefficient of Variation|Geometric Mean
2694923|NCT01283516|Secondary|Secondary Pharmacokinetics (PK) Parameter: CLss/F|CLss/F is the apparent total body clearance of drug from the plasma. There was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter CLss/F.|Cycle 1 Day 8 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||Litres/hour||Geometric Coefficient of Variation|Geometric Mean
2694924|NCT01283516|Secondary|Secondary Pharmacokinetics (PK) Parameter: Vz/F|Vz/F is the apparent volume of distribution during terminal phase (associated with Lambda_z)|PK Run-in dose escalation phase|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||Litre||Geometric Coefficient of Variation|Geometric Mean
2694925|NCT01283516|Secondary|Secondary Pharmacokinetics (PK) Parameter: CL/F|CL/F is the apparent total body clearance of drug from the plasma|PK Run-in dose escalation phase|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||Litres/hour||Geometric Coefficient of Variation|Geometric Mean
2694926|NCT01283516|Secondary|Secondary Pharmacokinetics (PK) Parameter: T1/2|T1/2 is the elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.|PK Run-in dose escalation phase|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||hour||Geometric Coefficient of Variation|Geometric Mean
2694927|NCT01283516|Secondary|Primary Pharmacokinetics (PK) Parameter: Cmax|Cmax is the maximum observed concentration. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Cmax.|PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation ion phase, Cycle 2 Day 1 of dose escalation & expansion phases|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2703604|NCT01217840|Secondary|C-reactive Protein (CRP) at Baseline and Week 24|Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.|Baseline; Week 24|Patients who completed the study were analyzed.|||mg/L||Standard Error|Mean
2694928|NCT01283516|Secondary|Primary Pharmacokinetics (PK) Parameter: Tmax|Tmax is the time to reach Cmax. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter Tmax.|PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||hour||Full Range|Median
2694929|NCT01283516|Secondary|Primary Pharmacokinetics (PK) Parameter: AUC0-24h|Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378. AUC0 - 24 is the AUC calculated to 24 hour. Cycle 1 Day 1 = C1D1; Cycle 1 Day 8 = C1D8; Cycle 2 Day 1 = C2D1. However, there was no PK sampling during C1D1 and C2D1 except for 750 mg dose to compute PK parameter AUC0-24.|PK run-in of dose escalation phase, Cycle 1 Day 8 of dose escalation phase, Cycle 1, Day 1 of dose escalation phase, Cycle 2 Day 1 of dose escalation & dose expansion phases|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2694930|NCT01283516|Secondary|Primary Pharmacokinetics (PK) Parameter: AUC0-last|The AUC from time zero to the last quantifiable concentration point (Tlast). Blood samples for PK analysis of LDK378 were collected during the study from patients receiving LDK378.|PK run-in of Dose Escalation phase|Pharmacokinetic Analysis Set (PAS) consisted of all patients (including NSCLC and non-NSCLC) who received at least 1 dose of LDK378 & had at least 1 evaluable PK sample|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2694931|NCT01283516|Secondary|Progression-free Survival Based on BIRC Assessment|Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.|275 weeks|Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.|||months||95% Confidence Interval|Median
2694932|NCT01283516|Secondary|Progression-free Survival Based on Investigator Assessment|Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.0. or death due to any cause.|275 weeks|Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.|||months||95% Confidence Interval|Median
2694933|NCT01283516|Secondary|Duration of Response (DOR) Based on BIRC|Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.|275 weeks|Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.|||months||95% Confidence Interval|Median
2694934|NCT01283516|Secondary|Duration of Response (DOR) Based on Investigator Assessment|Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.|275 weeks|Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.|||months||95% Confidence Interval|Median
2694935|NCT01283516|Secondary|Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment|Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).|275 weeks|Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.|||Percentage of participants||95% Confidence Interval|Number
2694936|NCT01283516|Secondary|Overall Response Rate (ORR) Based on Investigator Assessment|Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).|275 weeks|Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.|||Percentage of Participants||95% Confidence Interval|Number
2694955|NCT01283321|Primary|Bleeding Scores|Bleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.|intra-operatively and up to 24 hours postoperatively||||units on a scale||Standard Deviation|Mean
2694937|NCT01283516|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.|33 months|Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.|||Participants|||Number
2694938|NCT01283464|Primary|Global Photodamage Severity|A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage.|Week 24||||units on a scale||Standard Deviation|Mean
2694939|NCT01283386|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs|An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.|Up to approximately 5 years|All enrolled participants.|||percentage of participants|||Number
2694940|NCT01283386|Primary|Percentage of Participants With Phenotypic Remission|Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.|Up to approximately 5 years|Enrolled participants who were evaluable for this assessment.|||percentage of participants|||Number
2694941|NCT01283386|Primary|Overall Survival|Overall survival was defined as the time period from the first day of study treatment to participant death.|Up to approximately 5 years|Enrolled participants who died.|||days||95% Confidence Interval|Median
2694942|NCT01283386|Primary|Event-free Survival|Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|Enrolled participants who had an event of disease progression, relapse, or death.|||days||95% Confidence Interval|Median
2694943|NCT01283386|Primary|Progression-free Survival|Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.|Up to approximately 5 years|Enrolled participants who had disease progression at the end of the study.|||days||95% Confidence Interval|Median
2694944|NCT01283386|Primary|Duration of Response|Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|Enrolled participants who had disease progression after response to therapy.|||days||95% Confidence Interval|Median
2694945|NCT01283386|Primary|Percentage of Participants With Partial Remission|Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure at the end of therapy.|||percentage of participants|||Number
2694946|NCT01283386|Primary|Percentage of Participants With Stable Disease|Stable disease was defined as not meeting the criteria for partial remission or disease progression|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure at the end of therapy.|||percentage of participants|||Number
2694947|NCT01283386|Primary|Percentage of Participants With Disease Progression|Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure at the end of therapy.|||percentage of participants|||Number
2694948|NCT01283386|Primary|Percentage of Participants With Complete Remission|Complete remission was defined as the disappearance of all signs of disease.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure at the end of therapy.|||percentage of participants|||Number
2694949|NCT01283334|Secondary|Progression-free Survival (PFS)|Objective tumor responses were assessed every 2 cycles of chemotherapy with computed tomography or positron emission tomography/ computed tomography scans in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|The time of PFS was calculated as the time from study enrollment to the disease progression date, death date, or last contact, whichever came first, up to 25 months||||months||Full Range|Median
2694950|NCT01283334|Primary|To Measure the Safety and Clinical Effectiveness of the Combination of Carboplatin, Cetuximab and RAD001 in Patients With Advanced (Recurrent or Metastatic) Head and Neck Cancer|This phase 1 clinical trial used a standard 3 + 3 design. Four dose levels of everolimus were planned to be evaluated, and the standard 3 + 3 design with dose de-escalation was used in the trial. Namely, 3 patients were assigned to starting dose level 1. If no dose-limiting toxicity (DLT) was observed, the trial proceeded to the next dose level, and another cohort of 3 patients was enrolled. If at least 2 of the 3 patients experienced at least 1 DLT, then the dose level decreased; otherwise, if only 1 patient experienced DLT, then 3 more patients were enrolled at the same dose level. If none of the 3 additional patients experienced DLT, the dose was escalated; otherwise, the dose level decreased. Dose reduction continued until a dose level was reached at which 6 patients had been treated and at most 1 DLT was observed.|Within the first 21 days of therapy||||participants|||Number
2694961|NCT01283282|Primary|Nitroglycerin-mediated Vasodilation|Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually. Brachial artery images were obtained via ultrasound after three minutes of NTG administration. Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12||||percent change in diameter||Standard Error|Mean
2694962|NCT01283282|Primary|Flow-mediated Dilation (FMD)|Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12||||percent change in diameter||Standard Error|Mean
2694963|NCT01283152|Primary|Change in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study|||participants|||Number
2694964|NCT01283152|Secondary|Hospital Duration/Length of Stay||From time of admission to time of discharge or death||||days||Standard Deviation|Mean
2694965|NCT01283152|Primary|Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study|||participants|||Number
2694966|NCT01283139|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.|Day 1 up to Week 56|The safety population included all participants who received any investigational product.|||participants|||Number
2694967|NCT01283139|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.|||participants|||Number
2694968|NCT01283139|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.|||participants|||Number
2694969|NCT01283139|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.|Day 1 up to Week 74|The safety population included all participants who received any investigational product.|||participants|||Number
2694970|NCT01283139|Secondary|Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a FACIT-fatigue score <49 at baseline."|||percentage of participants|||Number
2694971|NCT01283139|Secondary|Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction|The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a CLASI activity score >=10 at baseline."|||percentage of participants|||Number
2694972|NCT01283139|Secondary|Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day|Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants on >=10 mg/day oral prednisone (or equivalent) at baseline."|||percentage of participants|||Number
2694987|NCT01282866|Primary|Hair Count|"The hair at the treatment area is counted at Baseline and 6 months following the last treatment.~Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline."|6 month following last treatment||||percentage of hair clearance||Standard Deviation|Mean
2694973|NCT01283139|Primary|Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants|SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with positive diagnostic test."|||percentage of participants|||Number
2694974|NCT01283139|Primary|Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])|SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).|Day 365|The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.|||percentage of participants|||Number
2694975|NCT01283035|Secondary|Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)||Up to 3 years|Number of participants experiencing toxicities.|||participants|||Number
2694976|NCT01283035|Secondary|Duration of Progression-free Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
2694977|NCT01283035|Secondary|Duration of Overall Survival Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
2694978|NCT01283035|Secondary|Development of Feedback Loop Activation and Target Inhibition With Akt Inhibitor MK2206 Via Analysis of Pre-treatment and Post-treatment Biopsies in Select Patients Enrolled in the Trial||Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
2694979|NCT01283035|Secondary|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 (as Assessed by Objective Tumor Response, Progression-free Survival, and Overall Survival)|The frequency of mutations in the PI3K/AKT and RAS pathways, copy number alterations, and PTEN loss and AKT expression as assessed by IHC will be tabulated. Associations between these markers with clinical outcome such as response rate and duration of PFS will be assessed.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
2694980|NCT01283035|Primary|Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|"If 4 or more of the final set of 29 patients demonstrate a response, then the null hypothesis H0: =< 5% can be rejected in favor of the alternative hypothesis H1: >= 20% with an alpha of 0.05 and beta of 0.20 (i.e., 80% power).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Up to 3 years|Five patients started study treatment.|||participants|||Number
2694981|NCT01283022|Primary|Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.|||pg/mL||Standard Deviation|Median
2694982|NCT01283022|Secondary|Rate of Adverse Events.|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48-72 hours).|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.|||percentage of participants|||Number
2694983|NCT01283022|Primary|Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal.|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.|||hours||Standard Deviation|Median
2694984|NCT01282866|Secondary|Hair Count|"The hair at the treatment area is counted at Baseline and 15 months following the last treatment.~Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline."|15 month following last treatment|The number of participants who completed 15 months follow up was 23 out of 35.|||percentage of hair clearance||Standard Deviation|Mean
2694989|NCT01282814|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2694990|NCT01282814|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2694991|NCT01282801|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2694992|NCT01282801|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2694993|NCT01282801|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2694994|NCT01282801|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2694995|NCT01282801|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2694996|NCT01282801|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2694997|NCT01282723|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers|The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.|9 - 42 Minutes||||Odds Ratio||95% Confidence Interval|Number
2694998|NCT01282710|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC|Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.|9 - 42 Minutes||||Seconds||Standard Deviation|Mean
2694999|NCT01282476|Secondary|Toxicities|Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening|1 year||||Participants|||Count of Participants
2695000|NCT01282476|Secondary|Progression-free Survival Rate|Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).|6 months||||percentage of participants||90% Confidence Interval|Number
2695001|NCT01282476|Primary|Overall Response Rate|"Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).~Overall response (OR) = Complete response (CR) + Partial response (PR)"|1 year||||percentage of participants||90% Confidence Interval|Number
2695002|NCT01282463|Secondary|PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2)||40 months|Zero participants analyzed. Data not collected.||||||
2695003|NCT01282463|Secondary|PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1)||40 months|Zero participants analyzed. Data not collected.||||||
2695004|NCT01282463|Secondary|PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B)||40 months|Zero participants analyzed. Data not collected.||||||
2695005|NCT01282463|Secondary|PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A)||40 months|Zero participants analyzed. Data not collected.||||||
2695006|NCT01282463|Secondary|Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF)||40 months|Zero participants analyzed. Data not collected.||||||
2695007|NCT01282463|Secondary|Number of Participants With Serum Anti-Icrucumab Antibody Assessment|A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.|Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose|Zero participants analyzed. Data not collected.||||||
2695008|NCT01282463|Secondary|Number of Participants With Serum Anti-Ramucirumab Antibody Assessment|Number of participants with at least one positive titer treatment emergent antibody positive neutralizing antibody detecting. A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.|Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOI|All randomized participants who received at least one dose of study drug and had baseline and post baseline anti-ramucirumab antibodies.|||Participants|||Count of Participants
2695009|NCT01282463|Secondary|PK: Cmin Icrucumab||Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI|All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2695010|NCT01282463|Secondary|PK: Cmax Icrucumab||Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI|All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2695011|NCT01282463|Secondary|PK: Minimum Concentration (Cmin) Ramucirumab||Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI|All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2695012|NCT01282463|Secondary|Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab||Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI|All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2695013|NCT01282463|Secondary|Number of Participants With Adverse Events (AEs)|A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Up To 41.7 Months|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2695014|NCT01282463|Secondary|Duration of Response|The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.|First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)|All randomized participants received one dose of study drug and had CR or PR.|||months||95% Confidence Interval|Median
2695015|NCT01282463|Secondary|Percentage of Participants Achieving Objective Response Rate (ORR)|Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.|Randomization to Measured PD (Up to 40 Months)|All randomized participants who received one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2695016|NCT01282463|Primary|Progression-Free Survival (PFS)|PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Randomization to Measured PD or Death From Any Cause (Up To 40 Months)|All randomized participants who received at least one dose of study drug. Participants censored: docetaxel arm = 40; docetaxel and ramucirumab arm = 34; docetaxel and Icrucumab arm = 41.|||months||95% Confidence Interval|Median
2695017|NCT01282424|Secondary|PK Parameter: AUClast|AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|Participants in the PK Analysis Set with available data were analyzed.|||hours x ng/mL||Standard Deviation|Mean
2695018|NCT01282424|Secondary|PK Parameter: Tmax|Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|Participants in the PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Mean
2695019|NCT01282424|Secondary|PK Parameter: Cmax|Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|Participants in the PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2695020|NCT01282424|Secondary|Idelalisib Plasma Concentration||Predose and at 1.5 hours (± 5 minutes) postdose on Day 29|Pharmacokinetic (PK) Analysis Set included participants in the ITT Analysis Set who had the necessary baseline and on-study measurements.|||ng/mL||Standard Deviation|Mean
2695021|NCT01282424|Secondary|Study Drug Exposure|The average idelalisib exposure was summarized.|Start of Treatment to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set were analyzed.|||months||Standard Deviation|Mean
2695022|NCT01282424|Secondary|Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms|"This composite endpoint measured the safety and tolerability profile of idelalisib. Clinically meaningful abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator."|Start of Treatment to End of Treatment (up to 81 months) plus 30 days|Participants in the ITT Analysis Set were analyzed.|||Participants|||Count of Participants
2695023|NCT01282424|Secondary|Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines|Analysis of the cytokine/chemokine was planned to be performed on a subset of samples from this study along with a subset of samples from other studies. Therefore, data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Enrollment to End of Treatment (up to 81 months)|||||||
2703605|NCT01217840|Secondary|Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
2695024|NCT01282424|Secondary|Change in Karnofsky Performance Status|The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|Baseline to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2695025|NCT01282424|Secondary|Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)|"Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.~The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications."|Baseline to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2695026|NCT01282424|Secondary|Overall Survival|Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause. OS was analyzed using KM estimates.|Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)|Participants in the ITT Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2695027|NCT01282424|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. PFS was analyzed using KM estimates.|Start of Treatment to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2695028|NCT01282424|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.|Start of Treatment to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.|||months||Inter-Quartile Range|Median
2695029|NCT01282424|Secondary|Lymph Node Response Rate|Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.|Start of Treatment to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2695030|NCT01282424|Secondary|Duration of Response|Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.|Start of Treatment to End of Treatment (up to 81 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.|||months||Inter-Quartile Range|Median
2695031|NCT01282424|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response [MR] for participants with WM) as assessed by the study independent review committee (IRC).~CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.~PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.~For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)"|Start of Treatment to End of Treatment (up to 81 months)|ITT Analysis Set included enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2695032|NCT01282372|Secondary|Mean Sleep Disturbance Subscale Score|The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab.|||Scores on a scale||Standard Deviation|Mean
2695033|NCT01282372|Secondary|Mean Visual Analogue Scale (VAS) Score|The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available VAS score at the study time points.|||Scores on a scale||Standard Deviation|Mean
2695034|NCT01282372|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.|||mg/L||Standard Deviation|Mean
2695073|NCT01282216|Primary|T-cell Immunity Augmentation|Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor.|up to 6 months|Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure.||||||
2695035|NCT01282372|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.|||mm/hr||Standard Deviation|Mean
2695036|NCT01282372|Secondary|Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero|"Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC."|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.|||Percentage of participants|||Number
2695037|NCT01282372|Secondary|Mean Psoriatic Arthritis Response Criteria (PsARC) Score|As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The PsARC score was not assessed in this study.||||||
2695038|NCT01282372|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available BASDAI score at the study time points.|||Scores on a scale||Standard Deviation|Mean
2695039|NCT01282372|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available HAQ-DI score at the study time points.|||Scores on a scale||Standard Deviation|Mean
2695040|NCT01282372|Secondary|Mean Disease Activity Score 28 (DAS28)|The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available DAS28 score at the study time points.|||Scores on a scale||Standard Deviation|Mean
2695041|NCT01282372|Primary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695042|NCT01282372|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695043|NCT01282372|Primary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695044|NCT01282372|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695045|NCT01282372|Primary|Mean Change From Baseline in Impairment While Working Due to Health Problem|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695046|NCT01282372|Secondary|Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695047|NCT01282372|Primary|Mean Change From Baseline in Work Time Missed Due to Health Problem|The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695048|NCT01282372|Secondary|Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups|The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
2695049|NCT01282294|Secondary|Time to Full Weight Bearing|The time from surgery to full weight bearing was assessed in days.|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). 3 patients never reached full weight bearing, and 1 dropped out before 6 weeks.|||days||Full Range|Median
2695074|NCT01282203|Secondary|Anesthesiologists' Duration of Clinical Experience With Anesthesia|Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.)|Baseline|Number of anesthesiologists participating in study.|||years||Standard Deviation|Mean
2695050|NCT01282294|Secondary|Patient's Perceived Satisfaction|Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|6 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~Patient satisfaction was completed by 84 patients."|||scores on a scale||Standard Deviation|Mean
2695051|NCT01282294|Secondary|Pain by Visual Analog Scale (VAS)|Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.|6 weeks, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695052|NCT01282294|Secondary|Likelihood to Develop a Non-union Assessed by Surgeon|The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695053|NCT01282294|Secondary|Likelihood to Develop Wound Infection Assessed by Surgeon|The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695054|NCT01282294|Primary|Infection Adverse Events|"Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:~superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue~deep incisional SSI, affecting deep soft tissue~organ/ space SSI (Osteomyelitis), affecting joint or bursa"|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||number of events|||Number
2695055|NCT01282294|Primary|Functional Outcome: WOMAC|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee.~Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695056|NCT01282294|Primary|Functional Outcome: IOWA Ankle Score|The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.|Baseline, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695057|NCT01282294|Secondary|Surgeon's Perceived Satisfaction|Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695058|NCT01282294|Secondary|Evidence of Functional Bone Union According to Johnson Classification|"Functional bone union was assessed according to Johnson et al.*:~F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."|||participants|||Number
2695059|NCT01282294|Secondary|Evidence of Economic Bone Union According to Johnson Classification|"Economic bone union was assessed according to Johnson et al.*:~E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."|||participants|||Number
2695226|NCT01280955|Secondary|B Cell Count at Day 90|B cell count at Day 90; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|90 days|the population includes subjects for which we have data at Day 90.|||number of B cells||Full Range|Median
2695060|NCT01282294|Secondary|Evidence of Anatomic Bone Union According to Johnson Classification|"Anatomic bone union was assessed according to Johnson et al.*:~A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."|||participants|||Number
2695061|NCT01282294|Primary|Quality of Life: EQ-5D|The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695062|NCT01282294|Primary|Quality of Life: SF-12 Mental Component Summary (MCS)|"The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.~It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695063|NCT01282294|Primary|Quality of Life: SF-12 Physical Component Summary (PCS)|"The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.~It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
2695064|NCT01282242|Secondary|Number of Subjects With Symptomatic Cerebral Edema|Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration.|Within 96 hours of tPA administration||||Participants|||Count of Participants
2695065|NCT01282242|Primary|Number of Subjects With Symptomatic Intracerebral Hemorrhage|Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS .|Within 7 days from tPA administration.||||Participants|||Count of Participants
2695066|NCT01282229|Secondary|Discomfort|Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70.|1-7 days|Subjects with missing data (e.g., missing diary entries) are not included in the analysis.|||sum of units on a scale|Participants|Full Range|Median
2695067|NCT01282229|Secondary|Change in Gingival Index|The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome.|Baseline, 6, 12 months||||units on a scale from 0-4|Participants|Standard Deviation|Mean
2695068|NCT01282229|Secondary|Change in Bleeding on Probing (BOP)|"Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement.~Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants."|Baseline, 6, 12 months||||percentage of pockets that bled|Participants|Standard Deviation|Mean
2695069|NCT01282229|Secondary|Change in Probing Depth (PD)|Positive numbers indicate average decrease in probing depth (improvement).|Baseline, 6, 12 months||||mm|Participants|Standard Deviation|Mean
2695070|NCT01282229|Primary|Gain in Clinical Attachment Level of Periodontal Tissues|Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.|Baseline, 6, 12 months|5-6 mm baseline PD partition had a different sample size than the 7+mm partition.|||mm|Participants|Standard Deviation|Mean
2695071|NCT01282216|Secondary|Recipient Vaccine-specific T-cell Response After Post-transplantation Vaccine|Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, and after receiving post-transplant vaccination.|up to 6 months|Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure.||||||
2695072|NCT01282216|Secondary|Recipient Vaccine-specific T-cell Response Post-transplant, Before Vaccination|Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, before receiving post-transplant vaccination.|up to 6 months|Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure.||||||
2695075|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command|All participants with available data at each time point were included in the analysis.|||Spearman's correlation coefficient|||Number
2695076|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the surgery|All participants with available data at each time point were included in the analysis.|||Spearman's correlation coefficient|||Number
2695077|NCT01282203|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the creatine kinase myocardial isoenzyme outcome measure.||||||
2695078|NCT01282203|Secondary|Cardiac Troponin (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.||||||
2695079|NCT01282203|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia|All participants with valid data were included in the analysis.|||Participants|||Number
2695080|NCT01282203|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||beats per minute||Standard Deviation|Mean
2695081|NCT01282203|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||mm Hg||Standard Deviation|Mean
2695082|NCT01282203|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||mm Hg||Standard Deviation|Mean
2695083|NCT01282203|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||mm Hg||Standard Deviation|Mean
2695084|NCT01282203|Primary|Patients' Overall Impression of Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.|||Participants|||Number
2695085|NCT01282203|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2695086|NCT01282203|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.|||Minutes||Standard Deviation|Mean
2695087|NCT01282203|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command.|All participants with available data were included in the analysis.|||Minutes||Standard Deviation|Mean
2695088|NCT01282203|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 10 minutes|All participants with available data were included in the analysis.|||Minutes||Standard Deviation|Mean
2695089|NCT01282164|Primary|Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test|The peak cortisol level during ACTH stimulation test in 3 patients with adult onset hypothalamic-pituitary disease who were older than 65 years of age and could not under go insulin tolerance test (ITT).|one year|Peak cortisol level during ACTH stimulation test in three patients with hypothalamic-pituitary disorders who were older than 65 and could not undergo ITT based on the study protocol|||ug/dL||Full Range|Median
2695102|NCT01282086|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia on Day 1|All participants with valid data were included in the analysis.|||participants|||Number
2695090|NCT01282164|Primary|Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).|The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak cortisol level during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders with three or more pituitary hormone deficiency other than GH deficiency. Two patients older than 65 years of age underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.|||ug/dL||Full Range|Median
2695091|NCT01282164|Primary|Peak Cortisol Level in Healthy Volunteers.|The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers.|one year|Peak cortisol levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in healthy volunteers|||ug/dL||Full Range|Median
2695092|NCT01282164|Primary|Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).|The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak cortisol levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency other than GH deficiency. One patient older than 65 years of age underwent ACTH stimulation test instead of ITT|||ug/dL||Full Range|Median
2695093|NCT01282164|Primary|Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease with three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak GH levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders with three or more pituitary hormone deficiency other than GH deficiency. Two patients older than 65 years underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.|||ng/mL||Full Range|Median
2695094|NCT01282164|Primary|Peak Growth Hormone (GH) Level in Healthy Volunteers|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers|one year||||ng/mL||Full Range|Median
2695095|NCT01282164|Primary|Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak GH levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency other than GH deficiency. One patient older than 65 years underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.|||ng/mL||Full Range|Median
2695096|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours|As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants|||Units on a scale|Participants|Standard Error|Mean
2695097|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours|As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants|||Units on a scale|Participants|Standard Error|Mean
2695098|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected. The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience (exp) with inhalation (inh) anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.|All participants with available data at each time point were included in the analysis.|||Spearman's correlation coefficient|||Number
2695099|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected. The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 (1 hour after the operation), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||Spearman's correlation coefficient|||Number
2695100|NCT01282086|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|All participants with available data were included in the analysis.|||U/L||Standard Deviation|Mean
2695101|NCT01282086|Secondary|Cardiac Troponin (Troponin T) (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available. No data were reported for this outcome measure during the study.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.||||||
2695227|NCT01280955|Secondary|NK Cell Count at Day 90|NK cell count at Day 90;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|90 days|the population includes subjects for which we have data at Day 90.|||number of NK cells||Full Range|Median
2695103|NCT01282086|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||beats per minute||Standard Deviation|Mean
2695104|NCT01282086|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||mm Hg||Standard Deviation|Mean
2695105|NCT01282086|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||mm Hg||Standard Deviation|Mean
2695106|NCT01282086|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n= the number of participants with available data at given time point.|||mm Hg||Standard Deviation|Mean
2695107|NCT01282086|Primary|Patients' Overall Impression of the Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.|||participants|||Number
2695108|NCT01282086|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2695109|NCT01282086|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.|||minutes||Standard Deviation|Mean
2695110|NCT01282086|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command|All participants with available data were included in the analysis.|||minutes||Standard Deviation|Mean
2695111|NCT01282086|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 16 minutes|All participants with available data were included in the analysis.|||minutes||Standard Deviation|Mean
2695112|NCT01281969|Secondary|The Degree of Treatment Response is Also Expected to Correlate With Decreased Inflammation in Specific Regions of the Brain, as Demonstrated by Changes on MRI||3 Months|||||||
2695113|NCT01281969|Secondary|The Degree of Treatment Response is Expected to Correlate With the Percentage Reduction in Antinuclear Antibody Titers Following IVIG Administration.|"Non-zero values of antinuclear antibodies are considered positive and reflective of an ongoing immune response in the individual. First, the number of participants who were classified at baseline as having positive antinuclear antibodies was calculated (see outcome measure data table, which states the number (AKA count) of participants who had positive antinuclear antibodies at baseline). We hypothesized that improvement in the ongoing immune response, and therefore a reduction in antinuclear antibody titers, would mediate the effect of IVIG on OCD symptom improvement. However, because very few participants were classified as positive at baseline, it was not appropriate to pursue the original question of whether a decline in antinuclear antibodies (i.e., from positive to negative) was related to symptom improvement."|Baseline||||Participants|||Count of Participants
2695114|NCT01281969|Secondary|Clinical Responder to Treatment|"Defined as a CGI-I score of 1 or 2 (much or very much improved) and a decrease in CY-BOCS of at least 30%"|6 weeks||||participants|||Number
2695115|NCT01281969|Secondary|Clinical Global Impressions Improvement|1=very much improved, 2=much improved, 3=slightly improved, 4=no change, 5=slightly worse, 6=much worse, 7=very much worse|6 weeks||||units on a scale||Standard Deviation|Mean
2695116|NCT01281969|Primary|Children's Yale-Brown Obsessive Compulsive Scale Total Score|Active IVIG will be significantly superior to sham IVIG in reducing OC symptoms and providing global relief of neuropsychiatric symptomatology. Total score is reported as the sum of all items and has a range of 0-40. Higher scores indicate more severe symptoms.|6 weeks||||units on a scale||Standard Deviation|Mean
2695117|NCT01281956|Secondary|Number of Subjects With an Abnormal ECG Result at the End of the Active and Placebo Periods|An electrocardiogram was administered to participants at the end of each treatment period, i.e., at the end of the PRX-0023 and Placebo treatment periods. The number of abnormal ECG readings was noted in this measure.|Three months|Missing data|||Participants|||Count of Participants
2695118|NCT01281956|Secondary|Number of Subjects With Abnormal Clinical Chemistry Labs at the End of the Active and Placebo Periods|The number of subjects with abnormal clinical chemistry labs which is defined as a value outside of the NIH Clinical Center normal range.|Three months||||Participants|||Count of Participants
2695143|NCT01281839|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 156 of 260 participants in the TMC435 treatment group and 84 of 133 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to treat population (defined as all participants who were randomized and received at least one dose of study medication).|||Percentage of Participants|||Number
2695119|NCT01281956|Secondary|Number of Subjects With an Abnormal CBC Result at the End of the Active and Placebo Periods|A Complete Blood Count (CBC) was administered at the end of each three month treatment period. A complete blood count test measures several components and features of your blood, including: Red blood cells (which carry oxygen), White blood cells (which fight infection), Hemoglobin (the oxygen-carrying protein in red blood cells), Hematocrit (the proportion of red blood cells to the fluid component (plasma) in your blood), Platelets, (which help with blood clotting). Abnormal increases or decreases in cell counts as revealed in a complete blood count may indicate an underlying medical condition, i.e., anemia (abnormal red blood cells, hemoglobin, and/or hematocrit), leucopenia (a decrease in white blood cells), leucocytosis (an increase in white blood cells), and thrombocytosis (an increase in platelets). Results were classified as either normal or abnormal.|Three months||||Participants|||Count of Participants
2695120|NCT01281956|Secondary|Results of Clinical Examination of the Musculoskeletal System at the End of the Active and Placebo Treatment Periods|A clinical examination of the musculoskeletal system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.|Three months||||Participants|||Count of Participants
2695121|NCT01281956|Secondary|Results of Clinical Examination of the Cardiovascular System at the End of the Active and Placebo Treatment Periods|A clinical examination of the cardiovascular system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.|Three months||||Participants|||Count of Participants
2695122|NCT01281956|Secondary|Results of Clinical Examination of the Respiratory System at the End of the Active and Placebo Treatment Periods|A clinical examination of the respiratory system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.|Three months||||Participants|||Count of Participants
2695123|NCT01281956|Secondary|Results of Clinical Examination of the Nervous System at the End of the Active and Placebo Treatment Periods|A clinical examination of the nervous system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.|Three months||||Participants|||Count of Participants
2695124|NCT01281956|Secondary|Mean Score on the Columbia Suicide Severity Rating Scale at the End of the Active and Placebo Periods|The Columbia Suicide Severity Rating Scale (C-SSRS) was administered to subjects at the end of each treatment period. The C-SSRS, is a suicidal ideation and behavior rating scale which evaluates suicide risk. The assessment rates an individual's degree of suicidal ideation on a scale, ranging from 0 to 6 as follows: 0 = No suicide ideation; 1 = Wish to be dead; 2 = Non-Specific Active Suicidal Thoughts; 3 = Active Suicidal Ideation with any methods (No Plan) without intent to act; 4 = Active Suicidal Ideation with some intent to act, without specific plan; 5 = Active Suicidal Ideation with specific plan and intent; and 6 = Actual Suicide Attempt|Three months|Missing data for one participant in the Placebo group|||Participants|||Count of Participants
2695125|NCT01281956|Secondary|The Mean Score on the Brief Visuospatial Memory Test-Revised (BVMT-R), at the End of the Active and Placebo Period.|The BVMT-R is a test of memory for visual information. Participants are shown a page with several geometric designs arranged in a 2x3 matrix and asked to study the designs. After the page is shown for a brief period the participant is asked to draw each figure.The same page is shown three times with recall requested after each presentation (immediate recall) and after a delay (delayed recall). Individual test results are compared to other people the same age (+/- 5 years).Test results are presented as T-scores which are conventionally used in neuropsychology. The participant's raw scores are compared to a population expected raw score, for a particular age group.That score is converted to a T-score.The interpretation of these T-scores is such that 50 is representative of the normal score in that age group in the general population.The standard deviation of these distributions are 10 units. A score of 30-40 is considered mildly impaired, 20-30 is indicative of severe problems|Three months|Unable to complete the delayed recall in one subject in the placebo arm|||psychometric T-score||Standard Deviation|Mean
2695126|NCT01281956|Secondary|Mean Score on the Hopkins Verbal Learning Test-Revised (HVLT-R) at the End of the Active and Placebo Periods|The HVLT-R is a word-list learning and memory test.The participant is read a list of words and asked to recall as many as possible, without regard to the order in which they were read.The list is read three times with recall requested after each presentation (immediate recall) and after a delay (delayed recall). Individual test results are compared to others of the same age (+/-5 years).Test results are presented as T-scores which are conventionally used in neuropsychology. The participant's raw scores are compared to a population expected raw score, for a particular age group. That score is converted to a T-score.The interpretation of these T-scores is such that 50 is representative of the normal score in that age group in the general population. The standard deviation of these distributions are 10 units. Therefore, a score between 30-40 is considered mildly impaired, 20-30 is indicative of severe problems with learning and memory and a score of 60-70 indicates a very good memory.|Three months|Unable to complete the delayed recall in one participant in the placebo arm.|||psychometric T-score||Standard Deviation|Mean
2703606|NCT01217840|Secondary|Interleukin-10 (IL-10) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
2695127|NCT01281956|Secondary|Mean Score on the Hamilton Depression Rating Scale at the End of the Active and Placebo Periods|The Hamilton Depression Rating Scale (HAM-D) was administered to participants at the end of each treatment period. The HAM-D is a multiple item questionnaire used to provide an indication of depression. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Although the HAM-D form lists 21 items, the scoring is based on the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2 with 0 = absent and 2 = frequent or severe. Scores range from 0 to 50 with a score of 0-7 representing normal and a score >/= 23 representing very severe depression.|Three months||||score on a scale||Standard Deviation|Mean
2695128|NCT01281956|Secondary|Mean Score on the Hamilton Anxiety Rating Scale at the End of the Active and Placebo Periods.|Participants were administered the Hamilton Anxiety Rating Scale (HAM-A) at the end of each three month treatment period, i.e., while participants were either on PRX-0023 or Placebo. The HAM-A measures an individual's severity of anxiety symptoms. The scale consists of 14 parameters, each defined by a series of symptoms. Each group of symptoms is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where </=17 indicates mild anxiety, 18-24 mild to moderate anxiety and 25-30 moderate to severe anxiety and >30 severe anxiety.|Three months||||score on a scale||Standard Deviation|Mean
2695129|NCT01281956|Secondary|Number of Participants With > 50% Lower Seizure Rate on PRX-0023.|Participants used a seizure calendar to record the number of seizures that occurred during each three month treatment period, i.e., while participants were either on PRX-0023 or Placebo. Seizure rate was calculated as the total number of seizures occurring during the three month period. The number of participants with >50% lower seizure frequency during the active compared with the placebo period was determined.|Three months||||Participants|||Count of Participants
2695130|NCT01281956|Primary|Seizure Frequency in the Active and Placebo Periods|Participants used a seizure calendar to record the number of seizures that occurred during the three month treatment period, i.e., while participants were either on PRX-0023 or Placebo. Seizure frequency was calculated as the total number of seizures occurring during each three month period. For each period a mean was calculated across subjects.|Three months||||number of seizures||Standard Deviation|Mean
2695131|NCT01281917|Secondary|Overall Survival|Length of time from enrollment until death.|Up to 60 months||||Months||95% Confidence Interval|Median
2695132|NCT01281917|Secondary|Duration of Response|Duration of Response is how long a response to therapy is held before a subject has progressive disease.|Up to 60 months||||months||95% Confidence Interval|Median
2695133|NCT01281917|Secondary|Tolerability of the Regimen|Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.|Up to 36 months||||Participants|||Count of Participants
2695134|NCT01281917|Secondary|Complete Response Rate|The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.|Up to 60 months||||Participants|||Count of Participants
2695135|NCT01281917|Secondary|Safety of This Regimen|Safety of the regimen will be measured by frequency and severity of adverse events.|Up to 36 months||||Participants|||Count of Participants
2695136|NCT01281917|Primary|Progression Free Survival|The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).|Up to 60 months||||Months||95% Confidence Interval|Median
2695137|NCT01281917|Primary|Overall Response Rate|The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 60 months||||Percentage of participants||95% Confidence Interval|Median
2695138|NCT01281865|Primary|Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)||At 8 weeks||||participants|||Number
2695139|NCT01281839|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows mean (standard deviation) of CL values of TMC435. To calculate the mean CL for the study, CL values were derived for each participant at each visit and then the median of CL values across visits for each participant was used to calculate the mean CL for the study.|From the time of administration through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||L/h||Standard Deviation|Mean
2695140|NCT01281839|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows mean (standard deviation) of C0h values of TMC435. To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then the median of C0h values across visits for each participant was used to calculate the mean C0h for the study.|Before administration of TMC435 through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng/mL||Standard Deviation|Mean
2695141|NCT01281839|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours (AUC 24hr) after dosing for TMC435. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then the median of AUC value across visits for each participant was used to calculate the mean AUC 24 hr for the study.|From the time of administration up to 24 hours after dosing through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng*h/mL||Standard Deviation|Mean
2695142|NCT01281839|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Weeks||95% Confidence Interval|Median
2695144|NCT01281839|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||Standard Error|Mean
2695145|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695146|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows mean time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2695147|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows mean time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2695148|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2695149|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
2695150|NCT01281839|Secondary|The Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695151|NCT01281839|Secondary|The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695152|NCT01281839|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695153|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695154|NCT01281839|Secondary|The Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695155|NCT01281839|Secondary|The Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695156|NCT01281839|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695203|NCT01280981|Secondary|Mean Blood Pressure Measurements at Week 36|Mean systolic and diastolic blood pressure measurements taken at week 36|approximately week 36|Intent to treat population of participants with week 36 blood pressure data.|||mmHg||Standard Deviation|Mean
2695157|NCT01281839|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695158|NCT01281839|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695159|NCT01281839|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695160|NCT01281839|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695161|NCT01281839|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695162|NCT01281839|Secondary|The Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with HCV ribonucleic acid (RNA plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695163|NCT01281839|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels. From Week 4 onwards, most participants in TMC 435 150mg 12Wks PR24/48 group had plasma HCV RNA levels below the limit of detection of the HCV RNA assay.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2695164|NCT01281839|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2695165|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695166|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695167|NCT01281839|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
2695168|NCT01281839|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
2695169|NCT01281644|Secondary|Patient Self-rated Severity|This outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the patient at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks||||units on a scale|Participants|Inter-Quartile Range|Median
2695170|NCT01281644|Primary|Difference in Disease Severity Scores|The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks||||units on a scale|Participants|Inter-Quartile Range|Median
2695171|NCT01281501|Secondary|Number of Participants That Have Overall Satisfaction on the Treatment|The satisfaction will be assessed by a simple, self-reported yes/no question.|1 hour after treatment||||participants|||Number
2695172|NCT01281501|Secondary|Number of Participants With Adverse Effect|The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.|1 hour after treatment|||||||
2695173|NCT01281501|Secondary|"Number of Participants in the Predefined Non-responders"|"Non-responders defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study."|pretreatment and 1 hour after treatment||||participants|||Number
2695174|NCT01281501|Secondary|"Number of Participants in the Predefined Responders"|"Responders define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study."|pretreatment and 1 hour after treatment||||participants|||Number
2695175|NCT01281501|Primary|Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment|"Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as Non-responders(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as Responders (good outcome)."|1 hour after treatment|All enrolled patients were analyzed with the intention-to-treat principles.|||millimeter||Standard Deviation|Mean
2695176|NCT01281475|Secondary|Presence of Tremors||1 year||||Participants|||Count of Participants
2695177|NCT01281475|Primary|Bayley Cognitive Age Equivalent at 1 Year||12 months||||months||Standard Deviation|Mean
2695178|NCT01281306|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set: The safety analysis set included all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
2695179|NCT01281306|Secondary|Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline.|8 weeks|Only participants of the full analysuis set (FAS), who had week 8 measurements, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||Number of participants|||Number
2695180|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were >= 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695181|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were leass than 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695182|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were >= 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
2695183|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were < 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
2695184|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Non-dippers|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695224|NCT01280955|Secondary|TNF-alpha at Day 30|TNF-alpha at day 30; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|30 days|the population includes subject for which we have data at Day 30.|||pg/mL||Full Range|Median
2695185|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Dippers|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695186|NCT01281306|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695187|NCT01281306|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
2695188|NCT01281306|Secondary|Change From Baseline in Nighttime maSBP and maDBP|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline and 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695189|NCT01281306|Secondary|Change From Baseline in Daytime maSBP and maDBP|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695190|NCT01281306|Secondary|Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2695191|NCT01281306|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
2695192|NCT01281306|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
2695193|NCT01281202|Secondary|Number of Participants With Cocaine Use||Week 3 - 9||||participants|||Number
2695194|NCT01281202|Primary|Abstinence|The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).|Weeks 8-9||||participants|||Number
2695195|NCT01281124|Secondary|Progression-free Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.||||||
2695196|NCT01281124|Secondary|Overall Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.||||||
2695197|NCT01281124|Primary|DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29|The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test. Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline.|Up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.||||||
2695198|NCT01281007|Secondary|Safety Will be Evaluated by the Adverse Events Occurence|Adverse events will be collected and followed in order to evaluate safety and tolerability|Day 5|||||||
2695199|NCT01281007|Primary|Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation|Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.|Day 5||||subjects|||Number
2695200|NCT01280981|Secondary|Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9|The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization|Month 9|Intent to treat participants who had an electrocardiogram (ECG) at month 9|||milliseconds||Standard Deviation|Mean
2695201|NCT01280981|Secondary|Mean Intraocular Pressure at Month 9|Mean intraocular pressure at month 9 or the early termination visit.|Day 1 up to Month 9|Intent to treat participants who had ophthalmic exams.|||mmHg||Standard Deviation|Mean
2695202|NCT01280981|Secondary|Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment|Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.|Day 1 to up to Month 9|Intent to treat population|||participants|||Number
2695204|NCT01280981|Secondary|Participants With Abnormal Gynecological Examinations|Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.|Day 1 to up to Month 9|Intent to treat population|||participants|||Number
2695205|NCT01280981|Primary|Participants With Treatment-Emergent Adverse Events (AEs)|Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.|Day 1 to up to Month 9|Intent to treat population (ITT)|||participants|||Number
2695206|NCT01280968|Primary|Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff||measured at week 1 and week 16||||percentage of change||Standard Error|Mean
2695207|NCT01280968|Primary|Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16||||percentage of change||Standard Error|Mean
2695208|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16||||percentage of change||Standard Error|Mean
2695209|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16||||percentage of change||Standard Error|Mean
2695210|NCT01280955|Secondary|TNF-alpha at Day 14|TNF-alpha at day 14; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|14 days|the population includes subject for which we have data at Day 14.|||pg/mL||Full Range|Median
2695211|NCT01280955|Secondary|TNF-alpha at Day 7|TNF-alpha at day 7; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|7 days|the population includes subject for which we have data at Day 7.|||pg/mL||Full Range|Median
2695212|NCT01280955|Secondary|IFN Gamma at Day 14|IFN gamma at day 14; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|14 days|the population includes subject for which we have data at Day 14.|||pg/mL||Full Range|Median
2695213|NCT01280955|Secondary|IFN Gamma at Day 7|IFN gamma at day 7; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|7 days|the population includes subject for which we have data at Day 7.|||pg/mL||Full Range|Median
2695214|NCT01280955|Secondary|IL-12 at Day 14|IL-12 at day 14; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|14 days|the population includes all participants for which we have data at day 14|||pg/mL||Full Range|Median
2695215|NCT01280955|Secondary|IL-12 at Day 7|IL-12 at day 7; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|7 days|the population includes all participants for which we have data at day 7|||pg/mL||Full Range|Median
2695216|NCT01280955|Secondary|B Cell Count at Day 60|B cell count at Day 60; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|60 days|the population includes subjects for which we have data at Day 60.|||number of B cells||Full Range|Median
2695217|NCT01280955|Secondary|B Cell Count at Day 30|B cell count at Day 30; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|30 days|the population includes subjects for which we have data at Day 30.|||number of B cells||Full Range|Median
2695218|NCT01280955|Secondary|NK Cell Count at Day 60|NK cell count at Day 60;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|60 days|the population includes subjects for which we have data at Day 60.|||number of NK cells||Full Range|Median
2695219|NCT01280955|Secondary|NK Cell Count at Day 30|NK cell count at Day 30;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|30 days|the population includes subjects for which we have data at Day 30.|||number of NK cells||Full Range|Median
2695220|NCT01280955|Secondary|CD8 Cell Count at Day 60|CD8 cell count at Day 60; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|60 days|the population includes subjects for which we have data at day 60|||number of CD8 cells||Full Range|Median
2695221|NCT01280955|Secondary|CD8 Cell Count at Day 30|CD8 cell count at Day 30; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|30 days|the population includes subjects for which we have data at day 30|||number of CD8 cells||Full Range|Median
2695222|NCT01280955|Secondary|CD4 Cell Count at Day 60|CD4 cell count at Day 60; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|60 days|The population includes subjects for which we have data at day 30.|||number of CD4 cells||Full Range|Median
2695223|NCT01280955|Secondary|CD4 Cell Count at Day 30|CD4 cell count at Day 30; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|30 days|The population includes subjects for which we have data at day 30.|||number of CD4 cells||Full Range|Median
2695225|NCT01280955|Secondary|IFN Gamma at Day 30|IFN gamma at day 30; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|30 days|the population includes subject for which we have data at Day 30.|||pg/mL||Full Range|Median
2695228|NCT01280955|Secondary|CD8 Cell Count at Day 90|CD8 cell count at Day 90; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|90 days|the population includes subjects for which we have data at day 90|||number of CD8 cells||Full Range|Median
2695229|NCT01280955|Secondary|CD4 Cell Count at Day 90|CD4 cell count at Day 90; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|90 days|The population includes subjects for which we have data at day 90.|||number of CD4 cells||Full Range|Median
2695230|NCT01280955|Secondary|CD3+ Cell Count at Day 90|Cell reconstitution - CD3+ cell count at day 90 post transplant. This is a marker for the function of your immune system.|90 Days|the population includes all participants for which we have data at day 90|||number of CD3+ cells||Full Range|Median
2695231|NCT01280955|Secondary|Participants Experiencing Grade II-IV Acute Graft Versus Host Disease|We are reporting on the number of participants experiencing a grade II-IV acute graft versus host disease will be assessed weekly through Day 100 post transplant. Staging and grading of Acute GvHD is graded by pattern of organ involvement and clinical performance status using the Grading Index of Acute GvHD (Gluckman) and the Grading Index of Acute GVHD by the CIBMTR (Centers for International Blood and Marrow Transplant Research)|100 days||||participants|||Number
2695232|NCT01280955|Secondary|IL-12 at Day 30|IL-12 at day 30; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|30 days|the population includes all participants for which we have data at day 30|||pg/mL||Full Range|Median
2695233|NCT01280955|Secondary|Absolute Lymphocyte Count at Day 90|Cell reconstitution - absolute lymphocyte count at day 90 post transplant.|90 days|the population includes all participants for which we have data at day 90|||number of lymphocytes||Full Range|Median
2695234|NCT01280955|Secondary|Transplant-related Mortality||100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||participants|||Number
2695235|NCT01280955|Primary|Plerixafor-associated Adverse Events||100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||number of adverse events|||Number
2695236|NCT01280955|Primary|Time to Platelet Recovery|platelet > 20,000/ul on 2 consecutive days|100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||days||95% Confidence Interval|Median
2695237|NCT01280955|Primary|Time to Neutrophil Recovery|leukocytes > 500/ul on 2 consecutive days|100 Days post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||days||95% Confidence Interval|Median
2695238|NCT01280942|Secondary|Clinical Outcomes and Process Measures|length of stay|Hospital discharge||||days||Inter-Quartile Range|Median
2695239|NCT01280942|Primary|Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm|The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.|Within 24 hrs of an EWS alert||||participants|||Number
2695240|NCT01280903|Secondary|Outcome Expectancy at 52 Weeks|"Measured by the Perceived Therapeutic Efficacy Scale in terms of the following:~Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695241|NCT01280903|Secondary|Arthritis Self-Efficacy at 52 Weeks|"Measured by the Arthritis Self-Efficacy Scale in terms of the following:~Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695242|NCT01280903|Secondary|Self-Efficacy at 52 Weeks|"Measured by the Self-Efficacy Scale in terms of the following:~Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695243|NCT01280903|Secondary|Health-Related Quality of Life at 52 Weeks|"Measured by the Short Form-36v2 in terms of the following:~Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695244|NCT01280903|Secondary|Fatigue at 52 Weeks|Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695245|NCT01280903|Secondary|Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks|Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695246|NCT01280903|Secondary|Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks|Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695247|NCT01280903|Secondary|Quadriceps Strength at 52 Weeks|Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.|6 months after the intervention period ends (week 52)||||pounds||Standard Error|Mean
2695248|NCT01280903|Secondary|Subjective Functional Status at 52 Weeks|Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2703607|NCT01217840|Secondary|Interleukin-6 (IL-6) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
2695249|NCT01280903|Secondary|Outcome Expectancy at 25 Weeks|"Measured by the Perceived Therapeutic Efficacy Scale in terms of the following:~Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695250|NCT01280903|Secondary|Arthritis Self-Efficacy at 25 Weeks|"Measured by the Arthritis Self-Efficacy Scale in terms of the following:~Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695251|NCT01280903|Secondary|Self-Efficacy at 25 Weeks|"Measured by the Self-Efficacy Scale in terms of the following:~Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695252|NCT01280903|Secondary|Health-Related Quality of Life at 25 Weeks|"Measured by the Short Form-36v2 in terms of the following:~Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695253|NCT01280903|Secondary|Fatigue at 25 Weeks|Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695254|NCT01280903|Secondary|Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks|Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695255|NCT01280903|Secondary|Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks|Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695256|NCT01280903|Secondary|Quadriceps Strength at 25 Weeks|Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.|At the end of the 6-month intervention period (week 25)||||pounds||Standard Error|Mean
2695257|NCT01280903|Secondary|Subjective Functional Status at 25 Weeks|Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695258|NCT01280903|Primary|Diastolic Blood Pressure at 52 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|6 months after the intervention period ends (week 52)||||mm Hg||Standard Error|Mean
2695259|NCT01280903|Primary|Systolic Blood Pressure at 52 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|6 months after the intervention period ends (week 52)||||mm Hg||Standard Error|Mean
2695260|NCT01280903|Primary|Objective Functional Status by the Short Physical Performance Battery at 52 Weeks|Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
2695261|NCT01280903|Primary|Objective Functional Status by the 6-minute Walk at 52 Weeks|Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.|6 months after the intervention period ends (week 52)||||yards||Standard Error|Mean
2695262|NCT01280903|Primary|Participation in Fitness Walking at 52 Weeks|Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.|6 months after the intervention period ends (week 52)||||minutes||Standard Error|Mean
2695263|NCT01280903|Primary|Performance of Lower Extremity Exercise at 52 Weeks|Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the subject reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period).|6 months after the intervention period ends (week 52)||||repetitions x sets/week||Standard Error|Mean
2695264|NCT01280903|Primary|Diastolic Blood Pressure at 25 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|At the end of the 6-month intervention period (week 25)||||mm Hg||Standard Error|Mean
2695265|NCT01280903|Primary|Systolic Blood Pressure at 25 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|At the end of the 6-month intervention period (week 25)||||mm Hg||Standard Error|Mean
2695266|NCT01280903|Primary|Objective Functional Status by the Short Physical Performance Battery at 25 Weeks|Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
2695267|NCT01280903|Primary|Objective Functional Status by the 6-minute Walk at 25 Weeks|Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.|At the end of the 6-month intervention period (week 25)||||yards||Standard Error|Mean
2695268|NCT01280903|Primary|Participation in Fitness Walking at 25 Weeks|Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.|At the end of the 6-month intervention period (week 25)||||minutes||Standard Error|Mean
2695269|NCT01280903|Primary|Performance of Lower Extremity Exercise at 25 Weeks|Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the participant reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period).|At the end of the 6-month intervention period (week 25)||||repetitions x sets/week||Standard Error|Mean
2695270|NCT01280721|Primary|Renal Function Test (Cys-C)|Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.|Baseline, Month 12, Month 24, and Month 36||||mg/L||Standard Deviation|Mean
2695271|NCT01280721|Primary|Renal Function Test (eGFR)|"Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period.~Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded."|Baseline, Month12, Month24, and Month36||||mL/min/1.73 m2||Standard Deviation|Mean
2695272|NCT01280721|Primary|Total Kidney Volume|"Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period.~Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg.~Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded."|Baseline, Month12, Month24, and Month36||||mL||Standard Deviation|Mean
2695273|NCT01280695|Secondary|Change From Baseline in High Molecular Weight Adiponectin|To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||ng/mL||Standard Error|Least Squares Mean
2695274|NCT01280695|Secondary|Change in Fasting Plasma Insulin|To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days|Baseline and 28 days|The Per-Protocol population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||µIU/mL||Standard Deviation|Least Squares Mean
2695275|NCT01280695|Secondary|Change From Baseline in Hematocrit|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||Change from baseline||Standard Error|Least Squares Mean
2695276|NCT01280695|Secondary|Change From Baseline in Body Weight|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||kg||Standard Error|Least Squares Mean
2695277|NCT01280695|Secondary|Change From Baseline in HbA1c|To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2695278|NCT01280695|Primary|Change From Baseline in Fasting Plasma Glucose|To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.|||mg/dL||Inter-Quartile Range|Median
2695279|NCT01280656|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||participants|||Number
2695280|NCT01280656|Secondary|Percentage of Participants Who Discontinued Treatment Due to Adverse Events|The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
2695281|NCT01280656|Secondary|Percentage of Participants With Null Response or No Responder at End of Treatment|Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
2695294|NCT01280604|Secondary|Alanine Aminotransferase(ALT)|ALT levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||international units/liter||Standard Deviation|Mean
2695295|NCT01280604|Secondary|High-density Lipoprotein,(HDL)|HDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
2695282|NCT01280656|Secondary|Percentage of Participants With Virologic Relapse up to Week 72|Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).|||percentage of participants|||Number
2695283|NCT01280656|Secondary|Percentage of Participants With Virologic Response at End of Treatment|Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
2695284|NCT01280656|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.|At Week 4|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
2695285|NCT01280656|Secondary|Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders|The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.|||mean percentage reduction of hemoglobin||Standard Deviation|Mean
2695286|NCT01280656|Secondary|Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment|The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)|||percentage of participants|||Number
2695287|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home|The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.|At Week 60 (SVR 12) and Week 72 (SVR 24)|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).|||percentage of participants|||Number
2695288|NCT01280656|Secondary|Percentage of Participants With Early Virologic Response at Week 12|An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.|At Week 12|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
2695289|NCT01280656|Secondary|Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used|The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported|At Week 24|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).|||participants|||Number
2695290|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment|SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).|||percentage of participants|||Number
2695291|NCT01280656|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment|Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 60|The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).|||percentage of participants|||Number
2695292|NCT01280604|Secondary|Serum Creatinine(SCr)|SCr levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
2695293|NCT01280604|Secondary|Aspartate Aminotransferase (AST)|AST levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||international units/liter||Standard Deviation|Mean
2695298|NCT01280591|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695299|NCT01280591|Secondary|Cumulative Proportion of Subjects Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population|||participants|||Number
2695300|NCT01280591|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
2695301|NCT01280591|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695302|NCT01280591|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
2695303|NCT01280591|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
2695304|NCT01280591|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
2695305|NCT01280591|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
2695306|NCT01280591|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
2695307|NCT01280591|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695308|NCT01280591|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695309|NCT01280591|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695310|NCT01280591|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695311|NCT01280591|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695312|NCT01280591|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695313|NCT01280591|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695314|NCT01280591|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2695315|NCT01280591|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
2695316|NCT01280591|Secondary|Total Sleep Time Measured by Actigraphy|Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2695317|NCT01280591|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
2695318|NCT01280591|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2695319|NCT01280552|Secondary|Progression Free Survival in HLA- A2 Patients|"Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype.~Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed"|2-3 yers|HLA-A2 patients|||months of progression free survival||95% Confidence Interval|Median
2695320|NCT01280552|Primary|Overall Survival in HLA-A2 Patients|Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.|2-3 years|Patients with HLA-A2 haplotype|||months of survival||95% Confidence Interval|Median
2695321|NCT01280552|Secondary|PFS|"Secondary Endpoints~PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed.~Population is all randomized patients ITT."|2-3 years|Intent to treat includes all randomized patients|||months of progression free survival||95% Confidence Interval|Median
2695322|NCT01280552|Primary|Overall Survival (OS)|The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis|2 -3 years|Intent to treat include all randomized patients|||months of survival||95% Confidence Interval|Median
2695323|NCT01280409|Secondary|Satisfaction With Medication as Assessed by a 5-point Likert Scale||At 6 weeks postpartum||||Participants|||Count of Participants
2695324|NCT01280409|Secondary|Satisfaction With Exercise as Assessed by a 5-point Likert Scale||At 6 weeks postpartum||||Participants|||Count of Participants
2695325|NCT01280409|Secondary|Satisfaction With Diet as Assessed by a 5-point Likert Scale||At 6 weeks postpartum||||Participants|||Count of Participants
2695326|NCT01280409|Secondary|Difficulty With Medication as Assessed by a 5-point Likert Scale||At 6 weeks postpartum||||Participants|||Count of Participants
2695327|NCT01280409|Secondary|Difficulty With Exercise as Assessed by a 5-point Likert Scale||At 6 weeks postpartum||||Participants|||Count of Participants
2695328|NCT01280409|Secondary|Difficulty With Diet as Assessed by a 5-point Likert Scale||At 6 weeks postpartum||||Participants|||Count of Participants
2695329|NCT01280409|Secondary|Self-reported Compliance With Medications||6 weeks postpartum||||Participants|||Count of Participants
2695330|NCT01280409|Secondary|Self-reported Compliance With Medications||3 weeks postpartum|46 in the placebo group and 53 in the metformin group were available by phone at 3 weeks postpartum to indicate medication compliance.|||Participants|||Count of Participants
2695331|NCT01280409|Secondary|HDL, LDL, Triglyceride|We will calculate the change in LDL, HDL, and triglyceride levels.|At 6 weeks postpartum|This data is not reported because blood samples were not analyzed for HDL, LDL, and triglyceride.||||||
2695332|NCT01280409|Secondary|Hemoglobin a1c|We will calculate the change in hemoglobin a1c.|At 6 weeks postpartum|This data is not reported because blood samples were not analyzed for Hemoglobin a1c.||||||
2695333|NCT01280409|Secondary|Number of Participants Who Achieved Their Ideal Body Weight||At 6 weeks postpartum||||Participants|||Count of Participants
2695334|NCT01280409|Secondary|Number of Participants Who Achieved Pre-pregnancy Weight||At 6 weeks postpartum||||Participants|||Count of Participants
2695335|NCT01280409|Primary|Weight Change|"The weight change in kilograms defined as:~weight change = Weight(pp) - Weight(6wk)"|within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)||||kg||Full Range|Median
2695336|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, maternal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"|||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
2695337|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, fetal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"|||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
2695372|NCT01279850|Secondary|Physician's Impression (CGIC) at Week 104|The physician's impression (clinical global impression of change [CGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.|At Week 104|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available and who satisfied the inclusion criteria among the baseline analysis population.|||Participants|||Number
2695338|NCT01280357|Secondary|The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM|During labor and delivery uterine contractions were measured between the Monica AN24 & the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement|between 35 mins & 15hrs during first & second stage labor|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in FDA 6 way trial for Fetal Heart Rate (FHR) and Uterine Activity (UA) 2 participants were used in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"|||Positive Percentage Agreement (PPA)||95% Confidence Interval|Mean
2695339|NCT01280266|Secondary|Dorsal-digital-difference.|The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.|baseline and 4 weeks||||degree celcius.||Standard Deviation|Mean
2695340|NCT01280266|Secondary|Time-averaged Peak Velocity (cm/Sec)|changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.|baseline and 4 weeks||||cm/sec||Standard Deviation|Mean
2695341|NCT01280266|Secondary|Change in Peak Systolic Flow (cm/Sec)|"Change in digital artery flow velocity in proper palmar digital artery in cm/sec.~0-unlimited"|baseline and 4 weeks||||cm/sec||Standard Deviation|Mean
2695342|NCT01280266|Secondary|Change in Digital Ulcer Number|0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.|baseline and 4 weeks||||Digital ulcers||Standard Deviation|Mean
2695343|NCT01280266|Secondary|Change in Physician's Global Assessment on Visual Analogue Scale (VAS)|"Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.~negative value (decrease in value) means improvement."|at 0 (baseline) and 4 weeks (after treatment)||||units on a scale||Standard Deviation|Mean
2695344|NCT01280266|Secondary|Change in Health Assessment Questionnaire (HAQ)|Ordinal scale 0-10 0 good 10 bad|0 and 4 weeks||||units on a scale||Standard Deviation|Mean
2695345|NCT01280266|Secondary|Change in the RP Duration|Change in the average RP duration in minutes (min) per attack. 0 -- unlimited|baseline and 4 weeks||||min per attack||Standard Deviation|Mean
2695346|NCT01280266|Secondary|Change in Raynaud's Condition Score (RCS)|"change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).~Range 0-10 ordinal scale 0..good 10.. bad"|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2695347|NCT01280266|Primary|RP Attacks Per Day|Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.|baselin and 4 weeks|14 patients in UA arm + 12 patients in AU arm|||attacks per day||Standard Deviation|Mean
2695348|NCT01280201|Secondary|Predictive Value of Baseline CTC (Count of 0) for Response to Treatma|Predictive value of the differente biomarkers included in the study was evaluated using multivariate analysis.|3 years||||Odds ratio||95% Confidence Interval|Number
2695349|NCT01280201|Secondary|Safety Assessment Criteria|Security and tolerance to the study medication will be determined evaluating the type, incidence, severity, timing, seriousness and connections with the treatment of the reported adverse events, physical examinations and laboratory tests. Toxicity will be classified according to NCI-CTCAE v 4.0.|3 years|Number of participantes with grade 3 or 4 AEs|||Participants|||Count of Participants
2695350|NCT01280201|Secondary|Duration of Response (DoR)|Defined, for the subset of patients with a confirmed CR o PR, as the time from first documented evidence of CR or PR until first documented disease progression or death due to any cause. The DR data will be censored the day after the last evaluation in those patients who did not present an objective tumoral progression and did not died during their participation in the trial. The DR will be assessed only in the subset of patients presenting objective response.|3 years||||months||95% Confidence Interval|Median
2695351|NCT01280201|Secondary|Radiological Objective Complete Response Rate|Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI, considered as the proportion of patients whose target lessions have dissaperead after treatment.|3 years||||Participants|||Count of Participants
2695352|NCT01280201|Secondary|Number of Patients Who Had an Event (Disease Progression or Death)|Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI, considered as the proportion of patietnts whose target lesions have been reported with a >=30% increase in the sum of the longest diameter of target lesions.|3 years||||Participants|||Count of Participants
2695353|NCT01280201|Primary|Clinical Benefit Rate|Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI: complete response (CR) considered as dissapereance of all target lesions: partial response (PR), considered as >=30% decrease in the sum of the longest diameter of target lesions, or stable disease (SD) considered as a decrease <30%, after pazopanib was started. Clinical benefit rate (CBR) was defined as the percentage of patients achieving CR, PR or SD.|6 months||||Participants|||Count of Participants
2695354|NCT01280123|Secondary|Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks|The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression.|44 weeks||||units on a scale||95% Confidence Interval|Mean
2695355|NCT01280123|Secondary|Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks|The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better.|44 weeks||||units on a scale||95% Confidence Interval|Mean
2695356|NCT01280123|Secondary|Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks|"The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort.~The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life."|44 weeks||||units on a scale||95% Confidence Interval|Mean
2695357|NCT01280123|Secondary|Change in Schwab and England Scale From Baseline to 44 Weeks|The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative).|44 weeks||||units on a scale||95% Confidence Interval|Mean
2695358|NCT01280123|Secondary|Change in Ambulatory Capacity From Baseline to 44 Weeks|"This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability.~Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline."|44 weeks||||units on a scale||95% Confidence Interval|Mean
2695359|NCT01280123|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks|"Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day).~The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.~The change is 44 weeks - baseline."|44 weeks||||units on a scale||Standard Error|Mean
2695360|NCT01280110|Secondary|Macular Thickness|Macular thickness will be measured with an Optical coherence tomography (OCT). Measures 5% under the normal population according to the OCT software will be considered break in the blood-retina barrier.|Baseline, 15 days and 30 days.|Statiscal power of 80%|||μm||Standard Deviation|Mean
2695361|NCT01280110|Primary|Aqueous Humor Flare|Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.|Baseline, 15 days and 30 days.|Statiscal power of 80%.|||photons/msec||Standard Deviation|Mean
2695362|NCT01280058|Other Pre-specified|Percentage of Patients With Ras Pathway Activation|The 95% confidence interval will be assessed. Cochran-Mantel-Haenszel test will be used to assess differences in the relationships between response and Ras pathway activation and the association of treatment groups on these relationships.|Baseline||||percentage of patients|||Number
2695363|NCT01280058|Other Pre-specified|Immunologic Correlative Markers|The inflammatory cytokine profile, immune effector cell phenotype and function, and NARA titers will be assessed and compared. Patterns of change in the longitudinal data on these markers will be evaluated for each of the correlative outcomes of interest.|Up to day 1 of course 12|data was not collected||||||
2695364|NCT01280058|Secondary|Overall Survival|Evaluated and compared between the two treatment groups using log-rank statistics and graphically using the methods of Kaplan and Meier.|From study entry to the time of death due to any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
2695365|NCT01280058|Secondary|Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1|95% confidence intervals will be calculated. Differences in objective response rates between the treatment arms will be assessed using Fisher's exact test.|Up to 4 years||||Participants|||Count of Participants
2695366|NCT01280058|Secondary|Incidence of Severe (Grade 3+) Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment, as Assessed by NCI CTCAE Version 4.0|Toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.|Up to 4 years||||percentage of patients|||Number
2695367|NCT01280058|Primary|Progression-free Survival Using RECIST v. 1.1|The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.|From study entry to the date of documented progression and/or death, assessed up to 4 years||||months||95% Confidence Interval|Median
2695368|NCT01279954|Secondary|Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods|Reduction of AC cellular activity and/or vitreous haze by 2 grades. Reduction of chorioretinal infiltrates or reduction of retinal vasculitis. Reduction of cystoid macular edema and/or retinal inflammation. With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.|Week 24|With the outcome measure being at 24 weeks, only one group is analyzed. All 10 subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.|||Participants|||Count of Participants
2695369|NCT01279954|Secondary|Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%|Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.|Week 24|With the outcome measure being at 24 weeks, only one group is analyzed. All 10 subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.|||Participants|||Count of Participants
2695370|NCT01279954|Secondary|Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity|improvement by 2 or more lines of best-corrected visual acuity With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.|Week 24|All subjects started the trial on open label abatacept, so only one group is being analyzed for this 24 week outcome.|||Participants|||Count of Participants
2695371|NCT01279954|Primary|Adverse Events|number of participants with adverse events|2 years|2 subjects were randomized to the 5 mg/kg abatacept group but one of these subjects only received 1 treatment before being removed from the study due to worsening. Only 1 of the 2 subjects randomized to this group completed the study. This explains the discrepancy between this table and the participant flow.|||Participants|||Count of Participants
2695373|NCT01279850|Secondary|Patient's Impression (PGIC) at Week 104|The patient's impression (patient global impression of change [PGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.|At Week 104|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available and who satisfied the inclusion criteria among the baseline analysis population.|||Participants|||Number
2695374|NCT01279850|Secondary|Change From Baseline in Participant-rated Sleep Interference Score at Week 104|The sleep interference (inability to sleep because of pain) experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 104 was presented along with standard deviation.|Baseline and at Week 104|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated sleep interference score was available and who satisfied the inclusion criteria among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2695375|NCT01279850|Secondary|Change From Baseline in Participant-rated Pain Score at Week 104|The pain experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 104 was presented along with standard deviation.|Baseline and at Week 104|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated pain score was available and who satisfied the inclusion criteria among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2695376|NCT01279850|Secondary|Clinical Effectiveness Rate|Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 104 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI.|At Week 104|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of clinical effectiveness was available and who satisfied the inclusion criteria among the baseline analysis population. Of these, participants evaluated as “impossible to judge” were excluded from the analysis population.|||Percentage of Participants||95% Confidence Interval|Number
2695377|NCT01279850|Secondary|Number of Participants With Adverse Drug Reactions Related to Vision-related Events|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.|From Week 1 to Week 104 at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2695378|NCT01279850|Secondary|Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.|From Week 1 to Week 104 at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2695379|NCT01279850|Secondary|Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.|From Week 1 to Week 104 at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2695380|NCT01279850|Secondary|Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.|From Week 1 to Week 104 at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2695381|NCT01279850|Secondary|Percentage of Participants With Serious Adverse Drug Reaction|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.|From Week 1 to Week 104 at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2695382|NCT01279850|Primary|Percentage of Participants With Adverse Drug Reaction|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.|From Week 1 to Week 104 at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2696772|NCT01266447|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2695383|NCT01279681|Other Pre-specified|Prognostic Single-nucleotide Polymorphisms (SNPs) for Grade 3+ Hypertension|Logistic regression models and conditional inference trees (or more generally conditional random forests) will be used to construct multi-variable models based on the SNPs identified as interesting.|Up to 42 days after treatment discontinuation|||||||
2695384|NCT01279681|Other Pre-specified|Overall Incidence of Grade >= 3 Toxicity in Elderly Patients|A logistic regression model will be used to determine the odd ratios for the occurrence of grade 3 + toxicity with a 95% confidence interval, and the overall association will be assessed by a likelihood ratio test with a two-sided alpha level of 0.05. As a secondary analysis, a multivariate logistic model will be applied including covariates for treatment arm and the stratification factors: age, PS and metastatic sites.|Up to 42 days after discontinuation of treatment|||||||
2695385|NCT01279681|Other Pre-specified|Proportion of Patients Reporting Satisfaction Using the Was It Worth IT (WIWI) Questionnaire|WIWI will be summarized descriptively to identify the number of patients who were satisfied with each treatment and indications for improvements therein. Proportion of patients' satisfaction will be compared between treatments by a Fisher's exact test. The impact of the clinical trial on patient QOL will be summarized via means and standard deviations and compared between treatment arms via a Wilcoxon rank sum test.|Baseline to up to 42 days after termination of study treatment|||||||
2695386|NCT01279681|Other Pre-specified|Change in QOL Using the Fatigue/Uniscale Assessment, Linear Analog Self-Assessment (LASA), and the European Quality of Live Five Dimensions Questionnaire (EQ-5D)|A cut-point of 5 or lower on the overall QoL question will be defined to be the primary cut-off for analysis as that has been demonstrated to represent clinically deficient QoL.|Baseline to up to 42 days after termination of study treatment|||||||
2695387|NCT01279681|Other Pre-specified|Change in Geriatric/Frailty Using the North Central Cancer Treatment Group (NCCTG) Brief Frailty Inventory and the Rockwood Frailty Index Physician and Patient-reported Items|The various measures of geriatric/frailty (Canadian Geriatric Society [CGSA], Rockwood, and NCCTG measures) will be compared head to head using Bland-Altman methods to assess the differences between clinician and patient reported frailty and the relative information obtained from the various assessments. This will be the first head to head comparison of its type to assess geriatric/frailty measures.|Baseline to 42 days after termination of study treatment|||||||
2695388|NCT01279681|Secondary|Number of Participants With Grade 3 Adverse Events At Least Possibly Related to Treatment|Adverse events were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 42 days after treatment discontinuation|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||Participants|||Count of Participants
2695389|NCT01279681|Secondary|Response Rate, Defined as the Percentage of Patients in Each Arm Who Have an Objective Status of Complete Response or Partial Response, Confirmed by a Second Assessment Measured at Least 6 Weeks From the Initial Assessment|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved Complete Response or Partial Response."|Up to 5 years|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2695390|NCT01279681|Secondary|Overall Survival|Overall survival was defined as the time (in months) from randomization to death.|Up to 5 years|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||months||Full Range|Median
2695391|NCT01279681|Primary|Progression-Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the time (in months) from the date of randomization to the date of documented disease progression or death, whichever occurs first. Patients were followed until progression (and progression was declared) regardless of whether the patient was on the first line treatment or not. Patients who progress following a missed scan will have their date of progression back-dated to the date of missing scan. Patients without a progression who are still alive at the time of analysis will be censored at the date of last follow-up.|Up to 5 years|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||months||Full Range|Median
2695392|NCT01279616|Primary|Event-free Survival|Event-free survival|1 year|The study was terminated and the PI has left the institution. Efforts were made to contact the PI but unsuccessful. No outcome measure data is available for the study.||||||
2695393|NCT01279564|Primary|Duration of Endotracheal Intubation|Time between introducing the laryngoscope and inflation of tube's cuff|The induction of general anesthesia, on the operating day (first day)||||seconds||Standard Deviation|Mean
2695394|NCT01279564|Primary|In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube||1 year|||||||
2695395|NCT01279486|Primary|Consumer Agreement|The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample.|During testing approximately 15 minutes|2 volunteers were not included due to insufficient sample. Another volunteer had a error result and there was insufficient sample to repeat.|||percentage of agreement|||Number
2695396|NCT01279447|Primary|Post op Pain Score|immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.|0 hours||||units on a scale||Standard Deviation|Mean
2695397|NCT01279343|Secondary|Admission to NICU or Special Care Nursery||birth to 96 hours of age||||Participants|||Count of Participants
2695398|NCT01279343|Secondary|Delivery Within 24 Hours||Delivery within 24 hours of induction||||Participants|||Count of Participants
2695399|NCT01279343|Secondary|Time to Complete Cervical Dilation|We will record the start time of induction until the patient's cervix is 10cm dilated|72 hours||||hour||Standard Deviation|Mean
2695400|NCT01279343|Secondary|NICU Admission||96 hours||||Participants|||Count of Participants
2706452|NCT01196104|Secondary|Number of Subjects Reporting Intermittent Coughing Episodes|Number of subjects reporting Intermittent Coughing Episodes|Baseline to Week 16|Safety Population|||Number of participants|||Number
2695401|NCT01279343|Secondary|Neonatal APGAR Scores|"APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score:~Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)"|5 minutes||||score on a scale||Full Range|Median
2695402|NCT01279343|Secondary|Chorioamnionitis||96 hours||||Participants|||Count of Participants
2695403|NCT01279343|Secondary|Number of Participants With Post-partum Hemorrhage||96 hours||||Participants|||Count of Participants
2695404|NCT01279343|Secondary|Number of Participants Experiencing Tachysystole With Deceleration||72 hours||||Participants|||Count of Participants
2695405|NCT01279343|Secondary|Successful Number of Vaginal and Cesarean Deliveries|To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.|72 hours||||Participants|||Count of Participants
2695406|NCT01279343|Primary|Time From Start of Labor Induction to Vaginal Delivery||72 hours||||hour||Standard Deviation|Mean
2695407|NCT01279317|Primary|Postprandial Glycemic Incremental Area Under the Curve|area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages|2 hr|all subjects completed study and are included in analysis|||mmol/L / 2hr||Standard Error|Mean
2695408|NCT01279265|Secondary|Fecal Calprotectin|Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.|90 days||||µg/g (feces)||95% Confidence Interval|Mean
2695409|NCT01279265|Secondary|Fecal Microbiota|Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.|90 days||||Shannon's diversity index value||Standard Deviation|Mean
2695410|NCT01279265|Primary|Daily Average Crying and Fussing Duration According to Barr Diary Records|The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.|90 days||||minutes||95% Confidence Interval|Mean
2695411|NCT01279200|Primary|Pregnancy Success Rate|Percentage of women in each arm who became pregnant within the study time frame.|3 menstrual/treatment cycles (approximately 28-33 days each)||||percentage of participants|||Number
2695412|NCT01279200|Secondary|Time to Conception, Measured in Cycles|Cycles means treatment/menstrual cycles, approximately 28-33 days.|3 menstrual/treatment cycles, or upon conception, whichever comes first|Numbers of participants analyzed changes from 8 with kits and 4 with ultrasound (enrolled) because time to conception can be measured only for those who conceived, so the 6 and 1 participants analyzed here are those who were successful in getting pregnant.|||menstrual cycles||Full Range|Mean
2695413|NCT01279187|Secondary|Bone Turnover: Bone Percentages|"Oc.S/BS cancellous: Osteoclast suface divided by bone surface. Osteoclastic surface as percent of total bone surface in cancellous bone. Percent cancellous bone perimeter with osteoclasts (large, multinuclear, TRAP positive cells).~OS/BS cancellous: Osteoid surface divided by bone surface. Percentage of cancellous bone perimeter covered with osteoid.~Oc.S/BS endocortical: Osteoclastic surface as percent of total bone surface in endocortical bone.~OS/BS endocortical: Percentage of endocortical bone perimeter covered with osteoid.~Oc.S/BS Periosteal: Osteoclastic surface as percent of total bone surface in periosteal bone.~Ob.S/BS Periosteal: Percent periosteal bone perimeter with osteoid and adjacent osteoblasts, identified as plump cells with a single, eccentric nucleus and a pale-staining golgi apparatus. Osteoblast Surface divided by bone surface in periosteal bone.~OS/BS Periosteal: Percentage of periosteal bone perimeter covered with osteoid."|10 weeks||||percentage (%)||Standard Deviation|Mean
2695414|NCT01279187|Secondary|Bone Turnover: Bone Perimeter Length|"Bone histomorphometry was used to assess bone perimeter length in mm as follows:~Cn.Pm cancellous: Cancellous Bone Perimeter Ec.Pm: endocortical bone perimeter Ps.Pm: Periosteal Periosteal bone perimeter"|10 weeks||||mm||Standard Deviation|Mean
2695415|NCT01279187|Secondary|Bone Turnover: Cortical Tissue Area|"Bone turnover was assessed indirectly by evaluating cellular parameters of PTH action (i.e. numbers of osteoblasts, osteoclasts, apoptotic osteoblasts). The methods used to obtain the outcomes described below were bone histomorphometry using the following abbreviation:~Ct.T.Ar: Ct Cort(ex)(ical) Tissue Area (2D)b First set refers to baseline pre-drug data and second set was taken at the end of the drug administration phase."|10 weeks||||mm2/week||Standard Deviation|Mean
2695416|NCT01279187|Secondary|Bone Turnover (Mineral Apposition Rates)|"Bone turnover was assessed indirectly by bone histomorphometry using the following abbreviations: Mineral Apposition Rate (MAR): Distance between 2 fluorochrome markers that comprise a double label on the surfaces of cancellous bone measured at an average of 4 equally-spaced sites per double label. These measurements will be performed on 20 double fluorochrome labels per bone and the average divided by the time between the midpoints of the two labeling periods. MAR serves as an index of osteoblast activity. Reported for cancellous (Cn), endocortical (Ec) at baseline (pre-drug intervention, listed as first set) and at the end of drug intervention (second set). First set refers to baseline information (pre-drug), and second set refers to data evaluated at the end of the drug administration phase. Periosteal (Ps) data and Ec.Mar Endocortical MAR second set was reviewed but no analyzable labeling was noted and so this data is not reported."|10 weeks||||um/day||Standard Deviation|Mean
2695417|NCT01279187|Primary|Bone Formation Rate|To determine the impact of PTH on bone quality and bone turnover in the oral cavity. The primary outcome variable will be bone formation rate.|10 weeks||||mm2/week||Standard Deviation|Median
2695418|NCT01279109|Secondary|Social Network|Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors.|2 times over 12 weeks (Week 6, Week 12)|59 participants in the intervention group completed at least one wave of social network data collection. Control group participants did not have protocol-specified group sessions to evaluate.|||number of discussion partner ties||Standard Deviation|Mean
2706453|NCT01196104|Secondary|Number of Subjects Reporting Cough Episodes|Number of Subjects Reporting Cough Episodes|Baseline to Week 16|Safety Population|||Number of participants|||Number
2695419|NCT01279109|Primary|Gestational Weight Gain|"Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy.~(Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.)"|Duration of pregnancy|Analysis is presented within baseline BMI categories and overall. The Overall Number of Participants Analyzed represents those study participants for whom medical records could be abstracted in the trial (87/135).|||Participants|||Count of Participants
2695420|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 40 weeks||||units on a scale||Standard Deviation|Mean
2695421|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 16 weeks||||units on a scale||Standard Deviation|Mean
2695422|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result.~The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
2695423|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result.~The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 16 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
2695424|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.~12-max. 129). A higher score indicates better performance."|Change from baseline in executive functioning at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
2695425|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.~12-max. 129). A higher score indicates better performance."|Change from baseline in executive function at 16 weeks (post-treatment)|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
2695426|NCT01279044|Secondary|Number of Condom-protected Anal Intercourse Events|"The outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.~Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months||||Self reported behavior in past 3 months|||Number
2695427|NCT01279044|Secondary|Number of Receptive UAI Events|"The outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Self reported behavior in past 3 months|||Number
2695428|NCT01279044|Secondary|Number of Instertive UAI Events|"The outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Self reported behavior in past 3 months|||Number
2695429|NCT01279044|Secondary|Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events|"The outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.~Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months||||Events in past 3 months|||Number
2695430|NCT01279044|Primary|Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Episodes in past 3 months|||Number
2695431|NCT01279044|Primary|Total Unprotected Anal Intercourse Partners|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Partners in past 3 months|||Number
2695432|NCT01279044|Primary|Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)|"The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Self reported events in past 3 months|||Number
2695433|NCT01278953|Primary|Incidence of Device-related Early-onset Primary Serious Adverse Events|Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.|12 months|The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. (n=3 excluded from TactiCath; n=2 excluded from the Control group)|||participants|||Number
2695434|NCT01278953|Primary|Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter|Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.|12 months|Primary effectiveness was calculated using the Per Protocol (PP) population (n=280). 10 subjects who had PVI attempted were excluded from the PP population.due to insufficient data. A medical panel (DSMB) blinded to treatment, adjudicated the exclusion of subjects from the analysis (n=3 from TactiCath; n=7 from Control)|||participants|||Number
2695435|NCT01278927|Secondary|Survival|Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.|6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
2695436|NCT01278927|Secondary|SF-36 Late Outcomes|The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|6 months||||units on a scale||Standard Deviation|Mean
2695437|NCT01278927|Secondary|Days of Hospitalization|The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.|100 days||||days||Standard Deviation|Mean
2695438|NCT01278927|Secondary|Nausea|Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.|100 days||||units on a scale||Standard Deviation|Mean
2695439|NCT01278927|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.|100 days||||units on a scale||Standard Deviation|Mean
2695440|NCT01278927|Secondary|Cancer and Treatment Distress (CTXD)|Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.|100 days||||units on a scale||Standard Deviation|Mean
2695441|NCT01278927|Primary|Functional Status|To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days||||units on a scale||Standard Deviation|Mean
2695442|NCT01278927|Secondary|Symptoms|Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days||||units on a scale||Standard Deviation|Mean
2707428|NCT01191190|Secondary|Detectable Minimal Residual Disease (MRD)|The patient who achieved a CR did not have detectable MRD in the bone marrow by four-color flow cytometry (<0.1% of cells).|2 years||||participants|||Number
2695443|NCT01278862|Primary|Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.|Performance reported as the # of crowns exhibiting 0, 1, 2 and 3 index score. Gingival Index (0=normal, 1=mild inflammation, 2=moderate inflammation, 3=severe inflammation. Plaque Index (0= none, 1= observed only via probe at on tooth surface at gingival crest, 2=moderate accumulation along gingival margin and adjacent tooth, 3= abundant plaque along gingival margin and adjacent tooth.|1 year|Number of crowns evaluated within each group after 1 year in vivo|||Crowns|Crowns||Number
2695444|NCT01278862|Primary|Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria|Performance reported as the % of teeth with perfect (alpha/A) scores. USPHS criteria: Color Match ( A=Ideal, B=perceptible mismatch but acceptable, C=obvious mismatch and unacceptable); Margin Adaptation (A=no visible crevice, B=crevice along <50% margin>1mm depth, C=crevice along>50% margin >1mm depth); Margin discoloration (A=none, B=Surface stain non penetrating, C=Penetrating; Surface Finish (A=smooth, B=moderately uniformly rough, C=significant pitts/voids; Crown Fracture (A=none, B=small but repairable, C= coping exposed/complete delamination; Proximal Contact (A=firm resistance to floss/ideal contact, B=light resistance/variable breadth, C=open; Sensitivity (A=none, B= slight but not uncomfortable, C=severe; Caries (A=no evidence, B= evident but repairable, C=evident/not repairable.|1 year|Number of crowns evaluated within each group after 1 year in vivo|||Crowns|Crowns||Count of Units
2695445|NCT01278797|Secondary|Time of Maximum Concentration of Amlodipine (TMAX)|Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial|||hours||Standard Deviation|Mean
2695446|NCT01278797|Primary|Maximum Observed Plasma Concentration (Cmax) of Amlodipine||Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial|||nanograms/milliliter||Standard Deviation|Mean
2695447|NCT01278797|Primary|Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)|Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial|||nanograms*hour/milliliter||Standard Deviation|Mean
2695448|NCT01278745|Secondary|Post-transplant Safety Outcomes Among Participants: Safety and Tolerability of Rituximab|Defined as participants that experienced at least one adverse event that was possibly, probably, or definitely related to the study drug (i.e., Rituximab or Placebo). Serious adverse events were used to evaluate this endpoint and the attribution was based on the DAIT Medical Monitor's assessment.|Transplantation through end of study, up to 1 year post transplantation|Randomized participants|||Participants|||Count of Participants
2695449|NCT01278745|Secondary|Number of Participants With Post-transplant Incidence of PTLD|The number of participants experiencing at least one post-transplant lymphoproliferative disorder (PTLD) occurrence during this trial. Post-transplant lymphoproliferative disorder is an uncontrolled proliferation of B cell lymphocytes latently infected with Epstein-Barr virus.|Transplantation through end of study, up to 1 year post transplantation.|Randomized participants|||Participants|||Count of Participants
2695450|NCT01278745|Secondary|Number of Participants With Post-transplant Serious Infections Requiring Intravenous Antimicrobial Therapy|Number of participants experiencing at least one serious infection requiring intravenous antimicrobial therapy which is used to kill the growth of microorganisms such as bacteria, fungi, or protozoans.|Transplantation through end of study, up to 1 year post transplantation.|Randomized participants|||Participants|||Count of Participants
2695451|NCT01278745|Secondary|Number of Participants With Development of Angiographically Evident Cardiac Allograft Vasculopathy|Cardiac allograft vasculopathy is an aggressive form of atherosclerosis that is characterized by the development of fibrosis affecting cardiac arteries that result in concentric narrowing of the arteries and, ultimately allograft failure. Development of cardiac allograft vasculopathy can be diagnosed via an angiograph which is an X-ray of the cardiac arteries by injecting a radiopaque substance such as iodine.|1 year|Randomized participants|||Participants|||Count of Participants
2695452|NCT01278745|Secondary|Number of Participants With Episodes of Rejection Associated With Hemodynamic Compromise (HDC)|The number of participants that experienced at least one episode of rejection associated with hemodynamic compromise (HDC). Rejection associated with HDC is when there is insufficient blood flow to the transplanted heart in association with acute rejection found in a biopsy. Local biopsies were used for this outcome measure.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
2695453|NCT01278745|Secondary|Incidence of Any Treated Rejection|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection (AMR) of the transplanted heart regardless of the presence of a biopsy.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
2695454|NCT01278745|Secondary|Incidence of Cellular Rejection|Cellular Rejection refers to the organ recipient's immune system recognizing a transplanted organ as foreign and mounting a response to it via cellular mechanisms. Cellular rejection was defined as a biopsy which met The International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory|6 to 12 months|Randomized participants with at least one centrally read heart biopsy|||Participants|||Count of Participants
2695455|NCT01278745|Secondary|Incidence of AMR|The number of participants who experienced antibody- mediated rejection (AMR). Antibody-mediated rejection (AMR) occurs when the subject develops antibodies directed against the transplanted heart. This was assessed based on local pathology biopsy reads.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
2695456|NCT01278745|Secondary|Incidence of BPAR (Any Grade)|The number of subjects who experienced any grade of biopsy proven acute rejection (BPAR) within the clinical trial. Biopsy proven acute rejection is when an examination of tissue removed from the transplanted organ indicates that the subject's immune system is trying to reject the graft. BPAR was defined as a biopsy which met The International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory.|6 to 12 months|Randomized participants with at least one centrally read heart biopsy|||Participants|||Count of Participants
2696062|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
2695457|NCT01278745|Secondary|Number of Episodes of Biopsy Proven Acute Rejection (BPAR) of Any Grade Per Participant|The number of times a participant experienced biopsy proven acute rejection (BPAR). Biopsy proven acute rejection is when an examination of tissue removed from the transplanted organ indicates that the subject's immune system is trying to reject the graft. BPAR was defined as a biopsy that met the International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory.|6 to 12 months|Randomized participants with at least one centrally read heart biopsy|||Participants|||Count of Participants
2695458|NCT01278745|Secondary|Re-transplantation or Re-listed for Transplantation|Re-transplantation is defined as the receipt of a subsequent heart transplant and re-listed for transplantation is being listed back on the heart transplant list to be re-transplanted.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
2695459|NCT01278745|Secondary|Death|Participants who died within 12 months post-transplant|12 months|Randomized subjects|||Participants|||Count of Participants
2695460|NCT01278745|Primary|Change in Percent Atheroma Volume (PAV)|Nominal or noticeable change, bad or good, from baseline to 1 year in percent atheroma volume (PAV) which is a measure of the degree of coronary arterial obstruction due to host alloimmune processes measured by intravascular ultrasound (IVUS) in a target coronary artery. Thus a decrease in PAV would be an indicator of less obstruction and a better outcome.|Baseline, 1 year|Randomized participants with available data at year one|||percent||Standard Deviation|Mean
2695461|NCT01278615|Primary|Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib|"Estimates of the disease control rate with the exact two-sided 95% confidence intervals. Response was measured utilizing Non-Hodgkins Lymphoma Response Criteria. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586. Using these criteria, 'disease control rate' encompassed patients who had either a CR, PR, and SD."|Up to 3 years||||percentage of disease control||95% Confidence Interval|Number
2695462|NCT01278615|Secondary|Time to Treatment Failure|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from study entry to treatment failure, defined as lymphoma progression or withdrawal from treatment due to adverse events, assessed up to 3 years. Patients who die without progression while still on therapy will be censored as of the time of death.||||days||95% Confidence Interval|Mean
2695463|NCT01278615|Secondary|Progression-free Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years||||days||95% Confidence Interval|Median
2695464|NCT01278615|Secondary|Overall Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-death and the corresponding two-sided 95% confidence intervals will be provided.|Date of study entry to the date of death, assessed up to 3 years||||days||95% Confidence Interval|Median
2695465|NCT01278615|Secondary|Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Percentage of patients experiencing any grade 3 or higher adverse event at least possibly attributed to the study drug. (Additional adverse event reporting will appear in the AE outcomes module.)|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
2695466|NCT01278615|Secondary|Duration of Response|The Kaplan-Meier procedure will be used to characterize the duration of response. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years|Zero participants were analyzed due to no response.||||||
2695467|NCT01278615|Primary|Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib|"Estimates of the response rate based on best response (CR and PR) with the exact two-sided 95% confidence intervals. Response for this lymphoma clinical study was measured utilizing Non-Hodgkins Lymphoma Response Criteria. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586."|Up to 3 years||||percentage of response||95% Confidence Interval|Number
2695468|NCT01278485|Secondary|Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment|On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.|Up to 12 Months Prior to Enrollment|All enrolled participants that completed the fear of weight gain questionnaire.|||Score on a Scale||Standard Deviation|Mean
2695469|NCT01278485|Secondary|Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment|Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.|Up to 12 Months Prior to Enrollment|All enrolled participants|||Participants|||Number
2695470|NCT01278485|Secondary|Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment|Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.|Day of Enrollment|All enrolled participants that completed the worry scale of the HFS II.|||Score on a Scale||Standard Deviation|Mean
2695471|NCT01278485|Primary|Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment|Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Day of Enrollment|All enrolled participants with a hemoglobin A1c measurement collected on the day of enrollment.|||Participants|||Number
2695472|NCT01278485|Secondary|Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment|The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.|Day of Enrollment|All enrolled participants that completed a questionnaire on the day of enrollment.|||Score on a Scale||Standard Deviation|Mean
2695473|NCT01278485|Secondary|Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment|The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.|Day of Enrollment|All enrolled participants that completed the TSQM on the day of enrollment.|||Score on a Scale||Standard Deviation|Mean
2695474|NCT01278485|Secondary|Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment|Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).|Day of Enrollment|All enrolled participants with a completed EQ-VAS questionnaire.|||Score on a Scale||Standard Deviation|Mean
2695475|NCT01278485|Secondary|Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment|The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Day of Enrollment|All enrolled participants with a completed EQ-5D questionnaire.|||Score on a Scale||Standard Deviation|Mean
2695476|NCT01278485|Primary|Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment|At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.|Up to 6 Months Prior to Enrollment|All enrolled participants that experienced hypoglycemia in the prior 6 months.|||Participants|||Number
2695477|NCT01278485|Primary|Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment|The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.|Up to 6 Months Prior to Enrollment|All enrolled participants.|||Participants|||Number
2695478|NCT01278407|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score|The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation [reported as cognitive fluctuation inventory]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.|||Units on a scale||Standard Deviation|Mean
2695479|NCT01278407|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.|||Units on a scale||Standard Deviation|Mean
2695480|NCT01278394|Secondary|Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG|Length of time to clinical evaluation of clear or at least 5 mm of CNG.|Baseline to 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||days||95% Confidence Interval|Mean
2695481|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
2695482|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 270|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
2703741|NCT01216410|Secondary|Satisfaction|1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.|24 h||||participants|||Number
2695483|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 180|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
2695484|NCT01278394|Secondary|Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 90|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
2695485|NCT01278394|Secondary|Clear Nail Growth of the Targeted Toenail|Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||millimeters||95% Confidence Interval|Mean
2695486|NCT01278394|Primary|Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360|Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the last observation was carried forward (LOCF) to impute missing observations.|||participants|||Number
2695487|NCT01278342|Secondary|The Percentage of Participants With Partial Response (PR) at 8 Months|"Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.~Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.~Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR|||percent||95% Confidence Interval|Number
2695488|NCT01278342|Secondary|The Percentage of Participants With Complete Response (CR) At 3 Months|"A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:~Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and~IGF-I within the Central Laboratory Normal Range (for age and gender)"|From Baseline to 3 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR|||percent||95% Confidence Interval|Number
2695489|NCT01278342|Primary|The Percentage of Participants With Complete Response (CR) at 8 Months|"A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:~Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and~IGF-I within the Central Laboratory Normal Range (for age and gender)."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR|||percent||95% Confidence Interval|Number
2695490|NCT01278303|Secondary|Secondary Safety Outcomes - Adverse Events|"Secondary Safety Outcomes~The proportion of patients experiencing any serious or somewhat serious adverse event related to the stent or implant procedure by 24 months follow up, such as: new aortic wall injury within the region of covered CP Stent implantation, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, arterial access site injury, bleeding, etc."|2 years||||percentage of participants|||Number
2695491|NCT01278303|Secondary|Secondary Efficacy Outcomes - 1 Year|"Secondary Efficacy Outcomes~At One Year: (A) Number of participants with arm-leg systolic blood pressure (SBP) differences <15 mmHg and (B) Number of participants with normal or only mildly elevated SBP, no more than mild arm-leg SBP, no clinically significant residual aortic wall injury AND no worsening in any of these three categories"|1 years||||participants|||Number
2695492|NCT01278303|Primary|Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening|"Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up~SIS is divided into 3 conditions & 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- > 159 mmHg or any hpn on >2 medications 3- 140-159 mmHg or elevated SBP on >2 medications 4- 130-139 mmHg or normal SBP on >2 medications 5- <130 mmHg on 0-2 meds~C2 Upper Extremity to Lower Extremity SBP difference 2- >59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- <15 mmHg~C3~Aortic Wall Injury severity levels:~Uncontained rupture or large aneurysm~Contained rupture or stable large aneurysm~Small contained rupture or moderate aneurysm~Acute, but stable AWI or small aneurysm~No injury or minor aortic wall irregularity not in need of treatment.~Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy"|Baseline and 12 months|Participants available for analysis at one year|||participants|||Number
2695493|NCT01278173|Primary|Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)|Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of IMP and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).|||µm||Standard Deviation|Mean
2695509|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 4|Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||Percentage of Participants|||Number
2696846|NCT01265875|Primary|VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.|10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.|Baseline, Days 1, 2, 3, 4, 7, 30.||||units on a scale||Standard Deviation|Mean
2695494|NCT01278173|Primary|Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)|Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of investigational medicinal product and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).|||dB||Standard Deviation|Mean
2695495|NCT01278160|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).|Weeks 0-16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||episodes|||Number
2695496|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage of subjects|||Number
2695497|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage of subjects|||Number
2695498|NCT01278160|Secondary|9-point SMPG (Self Measured Plasma Glucose) Profile|A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||mmol/L||Standard Error|Least Squares Mean
2695499|NCT01278160|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline||Week 0, week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements.|||percentage of glycosylated haemoglobin||Standard Deviation|Least Squares Mean
2695500|NCT01278030|Primary|Responder Rate|The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.|At 6 month follow-up|Patients who completed the 6 month follow-up with implant 3D echo data.|||percentage of participants|||Number
2695501|NCT01277887|Secondary|Sleep Efficiency|Self-reported sleep efficiency subscale of the Pittsburgh Sleep Quality Index. This is calculated as the percentage of total time spent asleep in a night compared to the total time spent in bed, multiplied by 100.|Change from Baseline at 4 weeks||||percentage of time asleep in bed||Standard Deviation|Mean
2695502|NCT01277887|Secondary|Self-Control to Resist Smoking Cues|To develop an effect size estimate for changes in self-control to resist smoking cues from baseline to the day before quitting smoking comparing smokers in the two counseling conditions.|4 Weeks|These data were not collected.||||||
2695503|NCT01277887|Primary|Smoking Abstinence|"Smoking abstinence is operationally defined as no smoking on the last 7 days of the last week of treatment. And no smoking within the last 7 days at the first follow-up visit 4 weeks after completing treatment."|1 Week||||participants|||Number
2695504|NCT01277861|Secondary|Coughing|Data include patients who coughed irrespective of the degree of coughing.|Intraoperative period|Per protocol|||Participants, number|||Number
2695505|NCT01277861|Secondary|Apnea|Apnea defined as no breathing for at least 30 s.|Induction of Anesthesia|Per protocol|||Participants, number|||Number
2695506|NCT01277861|Primary|Movement|The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).|Induction of Anesthesia|Per protocol|||Participants, number|||Number
2695507|NCT01277822|Secondary|Change From Baseline in Ankle Circumference at Week 8|Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.|Baseline and Week 8|All participants who received at least 1 dose of study drug and had available data for ankle circumference.|||mm||Standard Deviation|Mean
2695508|NCT01277822|Secondary|Percentage of Participants Who Had Peripheral Edema During the Study|A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.|up to 8 weeks|Safety Set defined as all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2695524|NCT01277783|Secondary|Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months|Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit.|12 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 5 had a missing R-wave amplitude measurement|||Bipolar Sensing Amplitude in milliVolts||Standard Deviation|Mean
2703742|NCT01216410|Secondary|Pruritus||0-24 hrs||||participants|||Number
2695510|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 8|Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||Percentage of Participants|||Number
2695511|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4|Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
2695512|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
2695513|NCT01277822|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4|Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
2695514|NCT01277822|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
2695515|NCT01277783|Secondary|Change in (NT-pro)BNP Levels From Baseline to 6 Months|Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months|baseline and 6 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 22 patients had a missing (NTpro)BNP measurement at baseline and/or 6 months.|||change in picograms per milliliter||Standard Deviation|Mean
2695516|NCT01277783|Secondary|Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months|Reported is the number of patients with at least one class improvement from baseline to 6 months|baseline and 6 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 16 patients had a missing MR measurement at baseline and/or 6 months.|||Participants|||Count of Participants
2695517|NCT01277783|Secondary|Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months|Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months|baseline and 6 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 17 patients had a missing LVEDD measurement at baseline and/or 6 months.|||millimeters change in LVEDD||Standard Deviation|Mean
2695518|NCT01277783|Secondary|Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months|Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months|6 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 27 patients had a missing LVESV measurement at baseline and/or 6 months.|||LVESV change in milliliters||Standard Deviation|Mean
2695519|NCT01277783|Secondary|Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months|Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months|baseline and 6 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 18 patients had a missing LVEF measurement at baseline and/or 6 months.|||Percent change in LVEF||Standard Deviation|Mean
2695520|NCT01277783|Secondary|Distance Walked at 6 Minute Hall Walk at the 12 Month Visit|Distance walked at the 6 minute hall walk test at the 12 month visit|12 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit, and 18 did not complete the test.|||Distance walked in meters||Standard Deviation|Mean
2695521|NCT01277783|Secondary|Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months|NYHA Class change was evaluated between baseline and the 6 months visit. Reported are the subjects with at least 1 class improvement from baseline to 6 months|baseline and 6 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 13 patients had a missing 6-months follow-up visit.|||Participants|||Count of Participants
2695522|NCT01277783|Secondary|Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months|Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit|12 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 3 had a missing impedance measurement|||Bipolar LV Pacing Impedance in Ohms||Standard Deviation|Mean
2695523|NCT01277783|Secondary|Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months|Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit|12 months|Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 4 had a missing bipolar pacing threshold measurement|||Bipolar LV pacing threshold in Volts||Standard Deviation|Mean
2696847|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 16|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 16|Participants with available data at given time points.|||pg/mL||Standard Deviation|Mean
2695525|NCT01277783|Secondary|Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor|Questionaires were collected for each LV lead implant attempt, reattempt, and LV lead modification. To evaluate the ease of positioning of the Model 3830 lead and the Models 6227ATS and 6248HS, JS, JL catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent was used for each of the ten questions on the questionnaire. Outcome reports the number of questionnaires where no single question was answered with Poor.|Implant|Participants analyzed are those in the Analysis cohort as described before (132). The unit of analysis is a questionnaire for each attempted Model 3820 lead implant (139). In 7 cases their was a repeat procedure (reported as repeat implant attempt or system modification).|||questionnaire|questionnaire||Count of Units
2695526|NCT01277783|Secondary|Implant Success|Number of participants with a successful implant of Model 3830 lead.|Implant|The Analysis cohort (132) includes the Baseline cohort (136) (Enrolled patients (138), excluding patients exited for eligibility violation without implant attempt and patients removed for major eligibility violation (2)), excluding patients that did not have implant attempt (4).|||Participants|||Count of Participants
2695527|NCT01277783|Primary|Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.|Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval.|6 months|The Analysis cohort (132) includes the Baseline cohort (136) (Enrolled patients (138), excluding patients exited for eligibility violation without implant attempt and patients removed for major eligibility violation (2)), excluding patients that did not have implant attempt (4).|||percentage of patients||95% Confidence Interval|Number
2695528|NCT01277757|Other Pre-specified|Cell Proliferation as Measured by the Change in Percent Ki-67 Positive Cells|Ki-67 will be scored as % positive cells to determine whether there is a change % Ki-67+ cells before treatment versus after 2 weeks of treatment. Initially, the goal was to look at predictors of response, but the number of responses was not enough to make a determination.|Baseline to 2 weeks|||||||
2695529|NCT01277757|Other Pre-specified|Apoptosis Assessed by Cleaved Caspase-3|Assessment of apoptosis by immunohistochemistry to active caspase-3. Initially, the goal was to look at predictors of response, but the number of responses was not enough to make a determination.|Up to 30 days after completion of study treatment, up to 1 year|||||||
2695530|NCT01277757|Secondary|Median Response Duration|"The duration of the response is from the time response is achieved until disease progression is detected. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.~Response re-evaluated every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response."|Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year|Two participants were not treated, and one was inevaluable.|||months||Full Range|Median
2695531|NCT01277757|Secondary|6 Month Progression-free Survival (PFS)|Number of participants progression free at 6 months. PFS is defined as the duration of time from start of treatment, or time of progression or death, whichever occurs first. The PFS for this outcome was assessed at 6 months post treatment.|From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months||||participants|||Number
2695532|NCT01277757|Primary|Number of Participants With Objective Response|Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of therapy will also be considered evaluable.) In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response, and then revert to scheduled repeat imaging.|4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.|||participants|||Number
2695533|NCT01277757|Primary|Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)|Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 weeks after completion of study treatment, for up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.|||participants|||Number
2695534|NCT01277744|Secondary|Overall Survival|From the date of diagnosis to the date of death or last follow up date for patient alive.|From the date of diagnosis to the date of death or last follow up date for patient alive up to 81 months||||months||95% Confidence Interval|Median
2695535|NCT01277744|Primary|Recurrence Free Survival|Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence|36 months after the last participant enrolled||||months||95% Confidence Interval|Median
2703743|NCT01216410|Secondary|Postoperative Nausea and Vomiting (PONV)||0-2h, 2-6h, 6-24h||||participants|||Number
2695536|NCT01277718|Primary|Maximum Observed Concentration of Cobimetinib||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2695537|NCT01277718|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2695538|NCT01277666|Secondary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 12|The Safety population comprised of all participants in the intent to treat population except those who did not take at least one dose of investigational product.|||Participants|||Number
2695539|NCT01277666|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12|The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. Each item response was graded from 1 to 7 for each area evaluated. A higher score indicated better function in that area. Total IBDQ score was obtained by summing up scores for all 32 questions. Total IBDQ score ranged from 32 to 224. A higher score indicated better quality of life and lower score indicated worse quality of life. Day 1 assessment was considered as Baseline. Change from Baseline was calculated by subtracting value at Baseline from value at Weeks 8 and 12.|Baseline (Week 0), Week 8 and Week 12|Intent to treat population. Only those participants available at specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2695540|NCT01277666|Secondary|Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8|Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI <150 points at Week 8 was presented.|Week 8|Intent to treat population.|||Percentage of participants||95% Confidence Interval|Number
2695541|NCT01277666|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8|CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of Participants with a clinical response CDAI decrease from baseline of >=100 points at Week 8 was presented.|Week 8|Intent to treat population.|||Percentage of Participants||95% Confidence Interval|Number
2695542|NCT01277666|Secondary|Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12|Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission defined as a CDAI score of less than 150 points at other time points was presented.|Week 8 and 12|Intent to treat population.|||Percentage of participants||95% Confidence Interval|Number
2695543|NCT01277666|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12|Responders were defined as participants with CDAI decrease from baseline of >= 100 points. CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI decrease from baseline of >=100 points was presented.|At Week 8 and 12|Intent to treat population|||Percentage of participants||95% Confidence Interval|Number
2695544|NCT01277666|Secondary|Percentage of Participants With CDAI Remission at Week 12|CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. Participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission at Week 12 was presented.|Week 12|Intent to treat population.|||Percentage of participants||95% Confidence Interval|Number
2695567|NCT01277523|Secondary|Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.|Time in days to first asthma exacerbation during the 12 week treatment period. The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.|||participants|||Number
2695545|NCT01277666|Primary|Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12|CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.|Week 12|The intent to treat population comprised of all participants randomized to double-blind treatment for 12 weeks.|||Percentage of participants||95% Confidence Interval|Number
2695546|NCT01277601|Secondary|Percentage of Participants Who Required Retreatment|Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.|Up to 120 weeks|Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.|||percentage of participants|||Number
2695547|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 120|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2695548|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 96|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2695549|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 72|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2695550|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2695551|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2695552|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2695553|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 120|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Baseline; Week 120|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.|||percentage of participants|||Number
2695628|NCT01276756|Secondary|Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)|The occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug.|throughout the period of treatment and up to 90 days after end of triple therapy||||participants|||Number
2703744|NCT01216410|Primary|Intraoperative Nausea and Vomiting|Comparison of intraoperative nausea and vomiting between the 3 groups.|Intraoperatively||||participants|||Number
2695554|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 96|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Baseline; Week 96|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.|||percentage of participants|||Number
2695555|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 72|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Baseline; Week 72|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.|||percentage of participants|||Number
2695556|NCT01277601|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120|"HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120."|Baseline; Weeks 72, 96, and 120|Full Analysis Set|||percentage of participants|||Number
2695557|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Weeks 96 and 120|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis."|Baseline; Weeks 96 and 120|Full Analysis Set|||percentage of participants|||Number
2695558|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.|||percentage of participants|||Number
2695559|NCT01277601|Primary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.|||percentage of participants|||Number
2695560|NCT01277549|Primary|CD34+ Cell Collection Efficiency|The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.|one day|Results are given for all per protocol subjects.|||% of processed CD34+ cells collected||Full Range|Median
2695561|NCT01277549|Secondary|Viability of the Collected MNC Product|The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.|One day|Per Protocol|||percentage of total WBCs collected||Full Range|Median
2695562|NCT01277549|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.|One day|Results given for all per protocol subjects.|||percentage of WBCs collected||Full Range|Median
2695563|NCT01277549|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.|One Day|Per protocol|||RBC % of product volume||Full Range|Median
2695564|NCT01277549|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|One Day|Per protocol|||% of processed platelets collected||Full Range|Median
2695565|NCT01277549|Primary|Mononuclear Cell Collection Efficiency|The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|One day|Results are given for all per protocol subjects.|||% of processed MNCs that were collected||Full Range|Median
2695566|NCT01277523|Secondary|Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests|Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From first drug administration until 30 days after last drug intake, up to 142 days|Treated set which included all randomised patients who were dispensed and received, at least one documented dose of trial medication.|||percentage of participants|||Number
2696848|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 16|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 16|Participants with available data at given time points.|||nmol/L||Standard Deviation|Mean
2695568|NCT01277523|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.|"Time in days to first severe asthma exacerbation during the 12 week treatment period. The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values.~A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days."|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.|||participants|||Number
2695569|NCT01277523|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.~Measured values presented are actually adjusted means"|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2695570|NCT01277523|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2695571|NCT01277523|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 12.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2695572|NCT01277523|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ total score responders.~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data for patients not withdrawn from the study were either categorised as no change or based on available data. Withdrawn patients were imputed based upon discontinuation reason.|||percentage of participants|||Number
2695573|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.~The ACQ is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||units on a scale||Standard Error|Mean
2695574|NCT01277523|Secondary|ACQ6 Score Responders|"Responder rates based on the ACQ6 score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline <= -0.5), no change (-0.5 < change from trial baseline <0.5) and worsening (change from trial baseline >= 0.5).~The ACQ is a scale containing 7 questions, each question has a 7- point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.~No statistical testing was performed on ACQ6 responders."|12 weeks|"Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.~Missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason."|||percentage of participants|||Number
2695575|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ6 Score.|"Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12~The ACQ is a scale containing 7 questions, each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||units on a scale||Standard Error|Mean
2695576|NCT01277523|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||litres||Standard Error|Mean
2695577|NCT01277523|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC 0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2695578|NCT01277523|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak0-3h) after 12 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2695579|NCT01277523|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||litres||Standard Error|Mean
2695580|NCT01277523|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||litres||Standard Error|Mean
2695581|NCT01277510|Secondary|Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; only participants with available data were included in the analysis.|||percent change||95% Confidence Interval|Least Squares Mean
2695582|NCT01277510|Secondary|Growth Velocity From End of Double-blind Phase to End of Open-label Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.|End of double-blind phase (Week 30) until end of the open-label phase (Week 60)|Full analysis set. Only participants with available data were included in the anaysis.|||cm/year||Standard Deviation|Mean
2695583|NCT01277510|Secondary|Growth Velocity From Baseline to End of Double-blind Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.|From Baseline to end of Efficacy Assessment at Week 30|Full analysis set; the last assessment in the double-blind phase was used due to the early termination of the study. Only participants with available data are included in the analysis.|||cm/year||95% Confidence Interval|Least Squares Mean
2695584|NCT01277510|Secondary|Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks|Full analysis set|||percent change||95% Confidence Interval|Least Squares Mean
2695585|NCT01277510|Secondary|Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; data for one participant in the Placebo group were not available.|||percent change||95% Confidence Interval|Least Squares Mean
2695586|NCT01277510|Secondary|Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period|"Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set|||percent change||95% Confidence Interval|Least Squares Mean
2695629|NCT01276756|Secondary|End-of-treatment Response|An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin|48 weeks +- 7 days after starting pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.|||participants|||Number
2696849|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 16|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 16|Participants with available data at given time point.|||ng/mL||Standard Deviation|Mean
2695587|NCT01277510|Secondary|Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30|Full analysis set|||pecentage of participants|||Number
2695588|NCT01277510|Primary|Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30|Full analysis set, which includes all randomized participants with at least 1 post-baseline assessment.|||percentage of participants|||Number
2695589|NCT01277354|Primary|CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6|The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.|6 weeks|Please note that there were only a total of 2 participants involved in this study. Funding was lost to continue and the study was terminated.|||Participants|||Count of Participants
2695590|NCT01277302|Secondary|Percentage of Participants With Intraretinal Edema|The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
2695591|NCT01277302|Secondary|Mean Change From Baseline in Central Foveal Thickness|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||µm||Standard Deviation|Mean
2695592|NCT01277302|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
2695593|NCT01277302|Secondary|Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
2695594|NCT01277302|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Letters||Standard Deviation|Mean
2695595|NCT01277302|Secondary|Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better|VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
2695596|NCT01277302|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
2695631|NCT01276756|Secondary|Rapid Virological Response|A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment|28 - 33 days after start of Pegylated interferon and ribavirin|"Only 1 patient in standard of care arm and 3 patients in the triple therapy arm missed doing the PCR test at week 4. These patients were thus not included in this particular analysis."|||participants|||Number
2695597|NCT01277302|Secondary|Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.|Month 7 through Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.|||Letters||Standard Deviation|Mean
2695598|NCT01277302|Primary|Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.|Baseline to Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the Monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.|||Letters||Standard Deviation|Mean
2695599|NCT01277211|Secondary|Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle|Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.|||Percentage of participants|||Number
2695600|NCT01277211|Secondary|Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle|"Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING."|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.|||Percentage of participants|||Number
2695601|NCT01277211|Primary|Pearl Index, by Treatment Group|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).|Up to 1 year|Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).|||Pregnancies per 100 woman-years||95% Confidence Interval|Mean
2695602|NCT01277159|Primary|Time it Takes for Nerve Block to Wear Off|Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?|up to 72 hours||||hours||Standard Deviation|Mean
2695603|NCT01277081|Secondary|Overall Cold Symptoms Score|"Overall cold symptom score was assessed by asking the question my cold symptoms are improved only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'."|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Error|Mean
2695604|NCT01277081|Secondary|Soothing Attribute Scores|"Soothing attribute of test treatment was assessed by asking the question if the hot drink is soothing at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'."|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Deviation|Mean
2695605|NCT01277081|Secondary|Cold Symptoms Score Post 60 Minutes|"A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered."|Baseline to 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||95% Confidence Interval|Mean
2695606|NCT01277081|Secondary|Cold Symptoms Score Post 15 Minutes|"A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered."|Baseline to 15 minutes|ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||95% Confidence Interval|Mean
2695630|NCT01276756|Secondary|Early Virological Response|"A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon.~A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon"|90 ± 7 days from the start of pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.|||participants|||Number
2695607|NCT01277081|Secondary|Breathing Score Post 60 Minutes|"A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered."|Baseline to 60 minutes|ITT population: All randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||95% Confidence Interval|Mean
2695608|NCT01277081|Primary|Breathing Scores Post 15 Minutes|"A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered."|Baseline to 15 minutes|Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a Scale||95% Confidence Interval|Mean
2695609|NCT01277042|Secondary|Number of Subjects With Outcome of Pregnancies|The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies.|||Participants|||Count of Participants
2695610|NCT01277042|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)|MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2695611|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 - 29) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2695612|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2695613|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.|During the 7 days (Days 0 - 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2695614|NCT01277042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.|During the 7 days (Days 0 - 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2695615|NCT01277042|Secondary|Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies|Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2696850|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 4|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 4|Participants with available data at given time points.|||pg/mL||Standard Deviation|Mean
2695616|NCT01277042|Secondary|Number of Subjects Seropositive Against HPV-16 and HPV-18|A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2695617|NCT01277042|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18|A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2695618|NCT01276847|Secondary|Change From Baseline in Gene Expression Score for Interleukin 17 (IL-17) in Psoriatic Lesions of Participants Treated With Etanercept|Participants had skin biopsies performed at baseline and after treatment with etanercept for 1,2,4 and 16 weeks. The expression of IL-17 mRNA was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Etanercept.|||Gene expression score||90% Confidence Interval|Median
2695619|NCT01276847|Secondary|Change From Baseline in Composite Gene Expression Score Based on Interleukin 23 (IL-23) Pathway Related Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The mRNA expression of eight pre-defined IL-23 pathway related genes, namely beta 4 defensin (DEFB4), CXC motif chemokine 8 (CXCL8), Interleukins 17A, 17F, 20, 22, 23A (IL-17, IL-17F, IL-20, IL-22, IL-23A) and cyclic AMP dependent protein kinase (CAMP) was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a reduction from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.|||Gene expression score||90% Confidence Interval|Median
2695620|NCT01276847|Primary|Change From Baseline in Composite Gene Expression Score Based on IL-12 Pathway Related Interferon Gamma (IFN-γ)-Modulated Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The expression of messenger RNA (mRNA) from three pre-defined IL-12 pathway related genes, modulated by interferon gamma (IFN-γ), namely IFN-γ, inducible nitric oxide synthase(iNOS) and CXC motif chemokine 10(CXCL10) was quantitated by real-time polymerase chain reaction (qPCR), with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a decrease from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.|||Gene expression score||90% Confidence Interval|Median
2695621|NCT01276821|Other Pre-specified|Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.|The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.|2 hours||||Minutes||Standard Deviation|Mean
2695622|NCT01276821|Secondary|Persistence of Cough at the End of 1 Week|Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.|7 days||||participants|||Number
2695623|NCT01276821|Secondary|Missed Days of Work of Caregivers|Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.|7 days||||participants|||Number
2695624|NCT01276821|Secondary|Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week||7 days||||participants|||Number
2695625|NCT01276821|Secondary|Relapse Rate|To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit|24 hours||||Participants|||Number
2695626|NCT01276821|Secondary|Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation||At the end of 2 hours||||participants|||Number
2695627|NCT01276821|Primary|Mean Change in Clinical Severity Score|"Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.~Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.~The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.~The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).~This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale."|2 hours||||units on a scale||Standard Deviation|Mean
2695632|NCT01276756|Primary|Sustained Virologic Response|sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)|180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).|All was intention-to-treat (ITT) analysis. Any patient who received at least one dose of interferon was included in the analyses.The only 2 dropouts (lost to follow-up) were calculated as failures.|||participants|||Number
2695633|NCT01276652|Post-Hoc|Presence of Normal Spectral Edge Frequency 95% (SEF95) Activity|SEF95 is normally higher during wakefulness during sleep. The normal sleep SEF95 profile is rhythmic with an approximately 90 minute periodicity. We analyzed the number of subjects who exhibited this normal profile.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.|||Participants|||Count of Participants
2695634|NCT01276652|Post-Hoc|Presence of Normal Slow Wave Activity|Slow wave activity in health exhibits diurnal and ultradian periodicity and a homeostatic decline at night. The number of subjects exhibiting these characteristics was calculated for each group.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.|||Participants|||Count of Participants
2695635|NCT01276652|Other Pre-specified|Normal Timing of 6-sulfatoxymelatonin Excretion|The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.|Average 4 days (patients followed to hospital discharge)|24-hour 6-sulfatoxymelatonin profiles were successfully collected in 16 subjects total. In one subject in the usual care (observational) group, there were insufficient data to determine melatonin timing.|||Participants|||Count of Participants
2695636|NCT01276652|Other Pre-specified|Occurrence of REM Sleep|Occurrence of identifiable rapid eye movement (REM) sleep in each subject.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.|||Participants|||Count of Participants
2695637|NCT01276652|Secondary|Subject Tolerance of the Environmental Modification Protocol|This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.|Average 4 days (patients followed to hospital discharge)|Only subjects who received the intervention were assessed.|||Subjects who tolerated the protocol|||Number
2695638|NCT01276652|Primary|Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.|This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.|Average 4 days (patients followed to hospital discharge)||||Participants|||Count of Participants
2695639|NCT01276639|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.|Baseline, Week 16, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695640|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means ability to work was not affected by psoriasis, and 10 means ability to work was completely affected by psoriasis. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695656|NCT01276639|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2695641|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||percentage of scheduled hours||Standard Deviation|Mean
2695642|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for specified parameter for each arm, respectively.|||hours||Standard Deviation|Mean
2695643|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.|||percentage of participants|||Number
2695644|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants unemployed (UEmp) at the time of assessment answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||participants|||Number
2695645|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||events|||Number
2695646|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||mm||Standard Deviation|Mean
2695714|NCT01276327|Secondary|Tmax for Pioglitazone|Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||hours||Full Range|Median
2695647|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695648|NCT01276639|Secondary|Joint Pain Assessment (JPA) Score|"The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain."|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695649|NCT01276639|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants|||Number
2695650|NCT01276639|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants|||Number
2695651|NCT01276639|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695652|NCT01276639|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695653|NCT01276639|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695654|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2695655|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695657|NCT01276639|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695658|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2695659|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2695660|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
2695661|NCT01276639|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||nails||Standard Deviation|Mean
2695662|NCT01276639|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695685|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2695663|NCT01276639|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695664|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2695665|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2695666|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2695667|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
2695668|NCT01276639|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of BSA||Standard Deviation|Mean
2696851|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 4|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 4|Participants with available data at given time points.|||nmol/L||Standard Deviation|Mean
2695669|NCT01276639|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
2695670|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695671|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695672|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2695673|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2695674|NCT01276639|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2695686|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Week 4, 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2695675|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants|||Number
2695676|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2695677|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
2695678|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
2695679|NCT01276639|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
2695687|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2695715|NCT01276327|Secondary|Tmax for Linagliptin|Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||hours||Full Range|Median
2695680|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
2695681|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
2695682|NCT01276639|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
2695683|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.|||percent change||Standard Error|Least Squares Mean
2695684|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2695698|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2695806|NCT01275339|Secondary|Change in RV Function|TAPSE, s' tissue Doppler, and Tei index|12 weeks and 6 months|||||||
2695688|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2695689|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
2695690|NCT01276639|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2695691|NCT01276639|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS) included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2695692|NCT01276535|Secondary|Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks|The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.|Baseline and 6 weeks||||lesions||Standard Deviation|Mean
2695693|NCT01276535|Secondary|Change From Baseline in Inflammatory Lesion Count at 6 Weeks|The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.|Baseline and 6 weeks||||lesions||Standard Deviation|Mean
2695694|NCT01276535|Primary|Grade on the Burton et al. Acne Severity Grade Scale|The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.|baseline and 6 weeks||||participants|||Number
2695695|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2695696|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||Day||Standard Deviation|Mean
2695697|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||Hours||Full Range|Median
2695699|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)|Day 1, 14, and 28|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2695700|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2695701|NCT01276509|Secondary|Immunogenicity Assessment of Anti-drug Antibodies (ADAs)|Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659|Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36|The safety analysis set included all participants who receive at least 1 dose of PF-00547659. Participants in placebo arm were not included in this analysis.|||events|||Number
2695702|NCT01276509|Secondary|Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer|Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.|Week 2, 4, 6, 8, 10 and 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants||90% Confidence Interval|Number
2695703|NCT01276509|Secondary|Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time|Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.|Week 2, 4, 6, 8, 10 and 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants||90% Confidence Interval|Number
2695704|NCT01276509|Secondary|Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission|Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).|Weeks 8 and week 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants|||Number
2695705|NCT01276509|Secondary|Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo|Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.|Week 0-12|The safety analysis set included all participants who received at least 1 dose of study medication.|||events|||Number
2695706|NCT01276509|Secondary|Safety and Tolerability of PF‑00547659 Dose Levels Versus Placebo|Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.|Week 0-12|The safety analysis set included all participants who received at least 1 dose of study medication.|||Number of participants|||Number
2695707|NCT01276509|Primary|Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate|Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.|Week 8 and week 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants|||Number
2695708|NCT01276457|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.|||Partcipants|||Number
2695709|NCT01276457|Secondary|Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft|A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.|||Participants|||Number
2695710|NCT01276457|Primary|Renal Function Assessed by Creatinine Clearance|Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.|Month 12, Month 18, and Month 24|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.|||mL/min||Standard Deviation|Mean
2695711|NCT01276457|Primary|Number of Participants With Biopsy-proven Acute Rejection|A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.|||Participants|||Number
2695712|NCT01276353|Primary|Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3||Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma|||ng/mL||Standard Deviation|Mean
2695713|NCT01276353|Secondary|Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status|All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i|Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2695716|NCT01276327|Secondary|AUC0-∞ of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2695717|NCT01276327|Secondary|AUC0-∞ of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2695718|NCT01276327|Secondary|AUC0-tz for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2695719|NCT01276327|Primary|Cmax of Pioglitazone|Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2695720|NCT01276327|Primary|AUC0-tz of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2695721|NCT01276327|Primary|Cmax of Linagliptin|Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2695722|NCT01276327|Primary|AUC0-72 of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2695723|NCT01276314|Primary|Skin Healing Time|Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.|One to two months for SJS/TEN cases, and one to six months for DRESS cases.|We determined if the enrolled participants had SJS/TEN and DRESS using the criteria and histopathological examinations.|||days||Full Range|Median
2695724|NCT01276301|Secondary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.|Within Day 15 to Day 25|Treated set|||percentage of participants|||Number
2695725|NCT01276301|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).|Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.|Day1 to Day 11|Treated set (TS) included all subjects who had taken at least one dose of trial medication.|||participants|||Number
2695726|NCT01276301|Other Pre-specified|Verapamil Plasma Concentration|"Verapamil plasma concentration were measured in order to confirm exposure.~Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ)."|Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration|Treated set (TS) included all subjects who had taken at least one dose of trial medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2695727|NCT01276301|Secondary|Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)|"Apparent volume of distribution during the terminal phase following an extravascular dose.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation|||L||Geometric Coefficient of Variation|Geometric Mean
2695728|NCT01276301|Secondary|Apparent Clearance in Plasma After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2695807|NCT01275339|Secondary|Change in Systemic Blood Pressure||6 and 12 weeks and 6 months|||||||
2695808|NCT01275339|Secondary|Change in Pulmonary Artery Pressure and Pulmonary Vascular Resistance as Assessed by Echo||12 weeks and 6 months|||||||
2695729|NCT01276301|Secondary|Mean Residence Time in the Body After Administration (MRTpo)|"Mean residence time of empagliflozin (empa) in the body after oral administration.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2695730|NCT01276301|Secondary|Terminal Half-life in Plasma (t1/2)|"Terminal half-life of empagliflozin in plasma.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2695731|NCT01276301|Secondary|Terminal Elimination Rate Constant (λz)|"Terminal elimination rate constant in plasma.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2695732|NCT01276301|Secondary|Time From 0 to Maximum Plasma Concentration (Tmax)|Time from last dosing to the maximum plasma concentration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
2695733|NCT01276301|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2695734|NCT01276301|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of empagliflozin (empa) in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol||Geometric Coefficient of Variation|Geometric Mean
2695735|NCT01276301|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2695736|NCT01276288|Secondary|Number of Subjects With Clinical Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests, 12-lead Resting Electrocardiogram (ECG), Physical Examination and Assessment of Tolerability by the Investigator|"Number of subjects with clinical relevant abnormalities in vital signs (blood pressure, pulse rate), 12-lead resting electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis, and monitoring of fasting plasma glucose), physical examination and assessment of tolerability by the investigator.~New abnormal findings were reported as Adverse Events (AE). Only Alanine aminotransferase normal under system organ class investigations was determined as an existing AE."|From first drug administration until up to 14 days after the last drug administration, up to 35 days|Treated set|||participants|||Number
2695737|NCT01276288|Primary|Urinary Sodium Excretion Over 24-hour run-in Periods|Urinary sodium excretion over 24-hour run-in periods to assess the harmonisation of electrolytes after intake of a standardised diet|Day 3, 2 and 1 before the first drug administration|PD analysis set completers|||mmol/day||Standard Error|Mean
2695738|NCT01276288|Secondary|Maximum Measured Concentration of TOR in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2695739|NCT01276288|Secondary|Area Under the Concentration-time Curve of TOR in Plasma (AUCτ,ss)|Area under the concentration-time curve of TOR in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2695740|NCT01276288|Secondary|Maximum Measured Concentration of HCT in Plasma (Cmax, ss)|Maximum measured concentration of HCT in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2695741|NCT01276288|Secondary|Area Under the Concentration-time Curve of HCT in Plasma (AUCτ,ss)|Area under the concentration-time curve of HCT in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2695742|NCT01276288|Secondary|Maximum Measured Concentration of Empa in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2695743|NCT01276288|Secondary|Area Under the Concentration-time Curve of Empa in Plasma (AUCτ,ss)|Area under the concentration-time curve of Empa in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|Pharmacokinetic (PK) set, including all patients of the treated set who provide at least one observation for at least one secondary PK endpoint of AUC τ,ss or C max,ss for any analyte under any treatment without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2695744|NCT01276288|Primary|The Change in Total Muscle Sympathetic Nerve Activity (MSNA) From Off- Treatment|The change in total Muscle sympathetic nerve activity (MSNA) that represents an area under the curve of all C-fiber action potentials per minute. This endpoint was evaluated only for Empa. For this endpoint a baseline value was not defined. However, the parameters obtained at 2 measurements time points during the trial were compared.|One day before the drug administration, then day 4 after the first drug administration|PD analysis set completers|||action potentials per min||Standard Error|Mean
2695745|NCT01276288|Primary|The Change in Micturition Frequency From the Baseline|For this endpoint the change in total micturition frequency from the baseline was only examined for EMPA where baseline was defined as the day before the first drug administration.|Baseline and day 5|PD analysis set completers|||voids per day||Standard Error|Mean
2695746|NCT01276288|Primary|Change in Urinary Weight From Baseline|"Change from baseline in urinary weight in a 24 hour (h)- collection period, where baseline is the last 24-h collection period before first trial drug administration in each treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||g/day||Standard Error|Mean
2695747|NCT01276288|Primary|Change in Body Weight From Baseline|"Change in body weight from baseline , where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||kg||Standard Error|Mean
2695748|NCT01276288|Primary|Change in pH in Capillary or Arterialised Blood From Baseline|"Change in pH in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||pH||Standard Error|Mean
2695749|NCT01276288|Primary|Changes in Bicarbonate Concentrations of Calcium, Bicarbonate Ions and Base Excess in Capillary or Arterialised Blood From Baseline|"Changes in bicarbonate concentrations of calcium, bicarbonate ions and base excess in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/ L||Standard Error|Mean
2695750|NCT01276288|Primary|Change in Urine Osmolality From Baseline|"Change in urine osmolality from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mOsm/kg||Standard Error|Mean
2695751|NCT01276288|Primary|Change in Urine pH From Baseline|"Change in urine pH from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||pH||Standard Error|Mean
2695752|NCT01276288|Primary|Change in Urea Concentration in Urine|"Change in urea concentration in urine from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/L||Standard Error|Mean
2695753|NCT01276288|Primary|Change in Serum Concentration of Fibroblast Growth Factor-23 (FGF- 23) From Baseline|"Change in serum concentration of fibroblast growth factor-23 (FGF- 23) from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline, The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||RU/mL||Standard Error|Mean
2695754|NCT01276288|Primary|Change in Serum Concentration of Aldosterone From Baseline|"Change in serum concentration of Aldosterone from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||nmol/L||Standard Error|Mean
2695755|NCT01276288|Primary|Change in Serum Concentration of Renin, Intact Parathyroid Hormone (iPTH) and 1,25-dihydroxyvitamin D From Baseline|"Change in serum concentration of Renin, intact parathyroid hormone (iPTH) and 1,25-dihydroxyvitamin D from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||pg/mL||Standard Error|Mean
2695756|NCT01276288|Primary|Change in Serum Concentration of Alkaline Phosphatase (ALP) From Baseline|"Change in serum concentration of ALP from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||U/L||Standard Error|Mean
2695757|NCT01276288|Primary|Change in Serum Concentration of Creatinine and Uric Acid From Baseline|"Change in serum concentration of Creatinine and Uric acid from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||umol/L||Standard Error|Mean
2695758|NCT01276288|Primary|Change in Serum Concentration of Sodium, Potassium, Magnesium, Calcium, Chloride, Phosphate, Glucose and Urea From Baseline|"Change in serum concentration of sodium, potassium, magnesium, calcium, chloride, phosphate, glucose and urea from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/L||Standard Error|Mean
2695759|NCT01276288|Primary|Change in Serum Osmolality From Baseline|"Changes in serum osmolality from baseline based on a blood sample.~Baseline was defined as the measurement obtained before the first drug administration in the first period.~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mOsm/Kg||Standard Error|Mean
2695760|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of N-terminal Telopeptide (NTx) From Baseline|"Change in urinary excretion in a 24-hour period of N-terminal telopeptide (NTx) from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||nM BCE/ mMC||Standard Error|Mean
2695761|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of Sodium, Potassium, Magnesium, Chloride, Calcium, Phosphate, Creatinine, Uric Acid, Glucose From Baseline|"Change in urinary excretion in a 24-hour period of sodium, potassium, magnesium, chloride, calcium, phosphate, creatinine, uric acid, glucose from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period. This applies also to sodium excretion in urine, which is additionally obtained one day before the drug administration before the second period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/day||Standard Error|Mean
2695762|NCT01276288|Primary|Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline|"Change in clearance of sodium, potassium, creatinine, magnesium, chloride,calcium, phosphate and uric acid from baseline, where baseline is defined as the value obtained from the last 24-h collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|Pharmacodynamic (PD) analysis set completers includes all evaluable patients of the treated set who provide a baseline and at least one on-treatment observation for at least one primary (PD) endpoint under any treatment without important protocol violations relevant to the evaluation of PD and who continued the trial as planned|||ml/min||Standard Error|Mean
2695763|NCT01276223|Primary|Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks|A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).|Baseline, up to 4 weeks|All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.|||units on a scale||Standard Deviation|Mean
2695764|NCT01276197|Primary|Diastolic BP Measurement at Follow-up|Participants BP measurement at 6-month follow-up|6-month following intervention||||mmHg||Standard Deviation|Mean
2695765|NCT01276197|Primary|Systolic BP at Follow-up|Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.|6 months after intervention|Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.|||mmHg||Standard Deviation|Mean
2695766|NCT01276171|Secondary|Total Success Rate||5 min|chi-squre test|||Participants|||Count of Participants
2695767|NCT01276171|Secondary|Time to Successful Cannulation||5 minutes||||min||Inter-Quartile Range|Median
2695768|NCT01276171|Primary|First Attempt Success Rate With 3 Different Technique|The primary objective of this study is to compare the first attempt success rate for radial artery cannulation between the palpation, Doppler and U/S guided technique when applied by anesthesia trainees. Secondary outcomes include: success rate within 5 minutes, time to successful cannulation compared with three different techniques.|5 minutes||||participants|||Number
2695769|NCT01276106|Primary|Change in HbA1c From Baseline|For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.|24 weeks|The Full Analysis Set included all randomized patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline HbA1c assessment.|||percentage points||Standard Error|Least Squares Mean
2695770|NCT01276054|Primary|Whether or Not a Patient Has Developed Grade 1+ LE|LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.|During the first year post-operatively|Unable to analyze due to early termination of the study||||||
2695771|NCT01275833|Primary|Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.|Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.|6 months|The study was terminated early: long PR intervals are relatively rare in this population, and it would take an inordinately long time to enroll sufficient patients. Because of the early termination of the study, no data was analyzed since the primary objective is underpowered.||||||
2695772|NCT01275755|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Treatment Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.|||Number of SBMs/week||Standard Error|Mean
2695773|NCT01275664|Secondary|Percentages of Patients With NIDL Based on FLIE||Up to day 6|Data not collected. Funding withdrawn.||||||
2695774|NCT01275664|Secondary|Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores||Baseline|Data not collected. Funding withdrawn||||||
2695775|NCT01275664|Secondary|Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0|Adverse events at least possibly related to treatment|Up to day 6|All eligible and evaluable subjects|||Participants|||Count of Participants
2695776|NCT01275664|Secondary|Change in Vomiting, Nausea and Total FLIE Scores||Baseline to day 6|Data was not collected. Funding withdrawn.||||||
2695777|NCT01275664|Primary|Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)|Number of participants who had complete control defined by no vomiting|During the 6 days following chemotherapy||||Participants|||Count of Participants
2695778|NCT01275625|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.|Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.|||Participants|||Number
2695779|NCT01275625|Secondary|Number of Participants With Genotypic Resistance.|The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.|||Participants|||Number
2695780|NCT01275625|Secondary|Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Ratio||Standard Deviation|Mean
2695781|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percent||Standard Deviation|Mean
2695782|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||cells/mcL||Standard Deviation|Mean
2695783|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percent||Standard Deviation|Mean
2695784|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||cells/microliter (cells/mcL)||Standard Deviation|Mean
2695785|NCT01275625|Secondary|Virologic Response: Rate of Virologic Failure at Week 48.|Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.|48 weeks|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Participants|||Number
2695786|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.|Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percentage of participants|||Number
2695787|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.|Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percentage of participants|||Number
2695788|NCT01275625|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.|Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|48 weeks|Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2695789|NCT01275586|Primary|Disease Response|To estimate the disease control rate (PD,SD, PR, CR) with Tasigna® in patients with neurofibromas (NF1) using standard RECIST criteria. Complete Response (CR) is defined as; disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Disease Progression (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|6 months||||Participants|||Count of Participants
2695790|NCT01275430|Secondary|Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side.|"Mean distance (mm) of PICC tip movement when the subject's arm is adducted from a 90° position to the subject's side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side .~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||mm||Standard Deviation|Mean
2695791|NCT01275430|Secondary|Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject's Side.|"Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°).~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||mm||Standard Deviation|Mean
2695809|NCT01275339|Secondary|Change in Quality of Life|Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)|6 and 12 weeks and 6 months|||||||
2695792|NCT01275430|Secondary|Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement|"Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed.~Note - this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location.~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||participants|||Number
2695793|NCT01275430|Secondary|Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.|"Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||mm||Standard Deviation|Mean
2695794|NCT01275430|Primary|Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.|"Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG.~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Time of PICC placement (Day 0)||||mm||Standard Deviation|Mean
2695795|NCT01275365|Secondary|Change of Derogatis Affective Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||units on a scale||Standard Error|Mean
2695796|NCT01275365|Secondary|Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale|The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||units on a scale||Standard Error|Mean
2695797|NCT01275365|Secondary|Change of Psychological Well Being Index (PGWBI)|The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||units on a scale||Standard Error|Mean
2695798|NCT01275365|Secondary|Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)|36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||units on a scale||Standard Error|Mean
2695799|NCT01275365|Secondary|Change of 50-meter Loaded Walking Test|Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. The test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags. Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||meters per second||Standard Error|Mean
2695800|NCT01275365|Secondary|Change of Stair Climbing Tests|Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||watts||Standard Error|Mean
2695801|NCT01275365|Secondary|Change of 6-minute Walking Distance|Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||meters||Standard Error|Mean
2695802|NCT01275365|Secondary|Change of Leg Press Power|Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||watts||Standard Error|Mean
2695803|NCT01275365|Secondary|Change of Maximal Voluntary Strength|Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||newton||Standard Error|Mean
2695804|NCT01275365|Primary|Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)|Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)|6 months from baseline|All randomized and treated participants with data available at the given time-point.|||kg||Standard Error|Mean
2695805|NCT01275339|Secondary|Change in AS Severity|Aortic valve area, transvalvular pressure gradients|12 weeks and 6 months|||||||
2695815|NCT01275339|Secondary|Safety and Tolerability|The following with be reported - frequency of the following: hypotension (SBP < 90 mmHg), symptomatic hypotension (symptoms of presyncope or syncope associated with SBP <90), syncope, hospitalization for a cardiac reason, myocardial infarction, new onset or worsening heart failure, and new sustained arrhythmia requiring intervention|6 and 12 weeks and 6 months|||||||
2695816|NCT01275339|Secondary|Change in Other Echocardiographic Indices of Diastolic Function|E/e' and deceleration time|12 weeks and 6 months|||||||
2695817|NCT01275339|Secondary|Change in Myocardial Fibrosis (ECV) on MRI||6 months|||||||
2695818|NCT01275339|Primary|Diastolic Function as Measured by Tissue Doppler e'|Measurement of e' (average of septal and lateral) on echo at each of the time points specified.|Baseline, 12 weeks, and 6 months|There were 0 enrolled that were randomized to placebo in the diabetic cohort; the total number enrolled in the study was small, so this happened randomly.|||cm/sec||Full Range|Mean
2695819|NCT01275313|Primary|Incidence of a Sitting-induced Pressure Ulcer|Skin assessments for incidence of sitting-induced pressure ulcer will occur once per week until occurrence of a pressure ulcer or 180 days|182 days||||Participants|||Count of Participants
2695820|NCT01275196|Secondary|Summary Statistics of Trough Imatinib and Major Metabolite CGP74588 of Imatinib and Nilotinib PK Concentration by Time Point|Pharmacokinetic Analysis Set|12 Months|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2695821|NCT01275196|Secondary|Actual Dose Intensity|Total dose/time on treatment (periods of zero dose were included).|End of Study (up to 40 months)|Safety set consisted of all randomized patients who received at least one dose of study medication.|||mg/day||Standard Deviation|Mean
2695822|NCT01275196|Secondary|Modified ELN2009 Criteria|"Patients satisfying criteria for several modified ELN 2009 categories are presented once under the worst category (Optimal> Suboptimal > Treatment failure). Patients in the Discontinued category are those who discontinued before the time point considered without satisfying any of the ELN 2009 criteria. Patients in the Missing category are those ongoing in the trial at the time point considered but with only missing or non evaluable data for ELN 2009 criteria."|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants|||Number
2695823|NCT01275196|Secondary|Best Complete Hematologic Response (CHR)|CHR was defined as having all of the following criteria present at any assessment, which was confirmed by another assessment at least after 4 weeks: • WBC count < 10 x 10E9 /L • Platelet count < 450 x 10E9 /L • Basophils < 5% • No blasts and promyelocytes in peripheral blood • Myelocytes + metamyelocytes < 5 % in peripheral blood • No evidence of extramedullary involvement. The assessment was not considered CHR, if there were any values indicative of CML in AP or BC (i.e. by blasts in bone marrow). For confirmation of CHR, both the initial CHR as well as the confirming assessment (at least 4 weeks after the initial assessment) had to satisfy all criteria mentioned above, without any assessment in between which indicated 'No response'.|Months 1, 3, 4, 5, 6, 9,12, 15,18, 21, 24, 30, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of participants||95% Confidence Interval|Number
2695824|NCT01275196|Secondary|Kaplan-Meier Estimates of Overall Survival (OS) on Treatment|Patients who discontinued study treatment early or completed the study protocol and did not enter into the extension protocol were to be followed for survival every 3 months for up to 2 calendar years from the date the last patient randomized received the first dose of study drug and every 6 months until Last Patient Last Visit. Overall survival (all deaths) was defined as the time between date of randomization and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment, i.e. overall survival on-study. The time was censored at the date of last assessment in the study for patients who are still being treated and at the date of last contact for patients who discontinued treatment.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
2695825|NCT01275196|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS) on Treatment|"Progression-free survival was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of death from any cause, whichever is earlier. This variable was analyzed in 2 ways:~On-treatment: included progressions to AP/BC or deaths occurring only on-treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease or cytogenetic evaluation) in the study before the cut-off date of the analysis for patients without event.~On-study: included progressions to AP/BC or deaths occurring in the study or during the follow-up period after discontinuation of study treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment."|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
2695826|NCT01275196|Secondary|Kaplan-Meier Estimates of Event-free Survival (EFS) on Treatment|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following:-Death due to any cause, - Progression to AP or BC, Loss of partial cytogenetic response (PCyR), - Loss of CCyR, - Loss of CHR|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
2695848|NCT01275170|Secondary|Part 1: VZpred of Cilastin in Combination With MK-7655|Cilastin is 1 of the 2 constituents of PRIMAXIN®. VZpred is the predicted volume of distribution during the terminal phase.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||liters (L)||95% Confidence Interval|Geometric Mean
2695827|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to Progression to Accelerated Phase/Blast Crisis (AP/BC) on Treatment|"Time to progression to AP/BC was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of CML-related death, whichever is earlier. This variable was analyzed in 2 ways:~On-treatment: included progressions to AP/BC or CML-related deaths occurring on treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease, or cytogenetic evaluation) in the study for patients without event.~On-study: included progressions to AP/BC or CML-related deaths occurring in the study or during the follow-up period after discontinuation of treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment"|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization|||Months||95% Confidence Interval|Median
2695828|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First CCyR Among Patients Who Achieved CCyR|Duration of CCyR (months) = (date of CCyR loss or censoring-date of first CCyR + 1)/30.4375|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization|||Months||95% Confidence Interval|Median
2695829|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First CCYR|Time to first CCyR (months) = (date of first CCyR - date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||months||95% Confidence Interval|Median
2695830|NCT01275196|Secondary|Best Complete Cytogenic Response (CCyR) Rate by Each Time Point|CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.|Months 6, 12, 18, 30, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
2695831|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First MMR Among Patients Who Achieved MMR|Duration of first MMR (months) = (date of loss of MMR or censoring-date of first MMR + 1)/30.4375.|End of Study (Up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
2695832|NCT01275196|Secondary|Durable MMR Rate at 24 Months|The rate of durable MMR at 24 months, defined as the proportion of patients who have achieved MMR at 12 months, and also maintain continuous MMR until the 24 month time point (1 month = 28 days) without intervening loss of MMR in between 12 and 24 months|24 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Perentage of Participants||95% Confidence Interval|Number
2695833|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First MMR|Time to first MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||months||95% Confidence Interval|Median
2695834|NCT01275196|Secondary|Best MMR by Each Timepoint|Best MMR rates by scheduled time point are cumulative response rates up to that time point. In this analysis, patients who had achieved MMR at or before the time point were counted as responders, no matter if they lost the response/discontinued or not. Therefore, this response rate represented the best observed response rate up to that specific time point.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
2695835|NCT01275196|Secondary|MMR Rate at Each Time Point|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as 'responders' and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as 'non-responders'. These time points including the 12 month data were calculated based on the final analysis after the end of the study.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
2695836|NCT01275196|Primary|Major Molecular Response (MMR) at 12 Months - With Imputation.|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as 'responders' and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as 'non-responders'. This endpoint was calculated based on the 12 month analysis.|12 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
2695849|NCT01275170|Secondary|Part 1: CLpred of Cilastin in Combination With MK-7655|Cilastin is 1 of the 2 constituents of PRIMAXIN®. CLpred is the predicted apparent total body clearance of drug.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||mL/min||95% Confidence Interval|Geometric Mean
2695837|NCT01275170|Primary|Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD)|The extraction coefficient of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating extraction coefficient was: Extraction Coefficient = ABS[100*(post-dialyzer concentration - pre-dialyzer concentration) / pre-dialyzer concentration].|1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, only Panel G is included in the analysis.|||Extraction coefficient||Geometric Coefficient of Variation|Geometric Mean
2695838|NCT01275170|Primary|Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD)|The CLD of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating CLD was: CLd = (1-Hct)*QB*[(pre-dialyzer concentration - post-dialyzer concentration) / (pre-dialyzer concentration)] where QB=350 mL/min and Hct=hematocrit.|1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, only Panel G participants requiring HD were included in the analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2695839|NCT01275170|Secondary|Parts 1 and 2: Percentage of Participants With ≥1 Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks)|All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis.|||Percentage of Participants|||Number
2695840|NCT01275170|Secondary|Part 2: Plasma AUC0-∞ of Omeprazole as a Probe Substrate of Cytochrome P450 Enzyme (CYP)2C19|Omeprazole was selected as a substrate of CYP2C19. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants.|Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose|Treated participants with severe renal deficiency or ESRD and their matched controls (Panels E-H) who complied with the protocol enough to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panels A-D were not included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Mean
2695841|NCT01275170|Secondary|Part 2: Plasma AUC0-∞ of Midazolam as a Probe Substrate of Cytochrome P450 Enzyme (CYP)3A4|Midazolam was selected as a substrate of CYP3A4. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants.|Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose|Treated participants with severe renal deficiency or ESRD and their matched controls (Panels E-H) who complied with the protocol enough to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panels A-D were not included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Mean
2695842|NCT01275170|Secondary|Part 2: Plasma AUC0-∞ of Caffeine as a Probe Substrate of Cytochrome P450 Enzyme (CYP)1A2|Caffeine was selected as a substrate of CYP1A2. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants.|Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose|Treated participants with severe renal deficiency or ESRD and their matched controls (Panels E-H) who complied with the protocol enough to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panels A-D were not included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Mean
2695843|NCT01275170|Secondary|Part 1: CLR of Cilastin in Urine|CLR represents renal clearance in urine. Urine was collected for 24 hours postdose.|Predose to 24 hours postdose|Treated participants with urine samples who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panel G was not sampled due to limitations in producing urine and was thus not included in the analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2695844|NCT01275170|Secondary|Part 1: CLR of Imipenem in Urine|CLR represents renal clearance in urine. Urine was collected for 24 hours postdose.|Predose to 24 hours postdose|Treated participants with urine samples who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panel G was not sampled due to limitations in producing urine and was thus not included in the analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2695845|NCT01275170|Secondary|Part 1: Renal Clearance (CLR) of MK-7655 in Urine|CLR represents renal clearance in urine. Urine was collected for 24 hours postdose.|Predose to 24 hours postdose|Treated participants with urine samples who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panel G was not sampled due to limitations in producing urine and was thus not included in the analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2695846|NCT01275170|Secondary|Part 1: Apparent t½ of Cilastin in Combination With MK-7655|Cilastin is 1 of the 2 constituents of PRIMAXIN®. Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2695847|NCT01275170|Secondary|Part 1: Tmax of Cilastin in Combination With MK-7655|Tmax is the time at which the highest plasma drug concentration was observed.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||hours||Full Range|Median
2695907|NCT01275066|Primary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.|||meters||Standard Deviation|Mean
2695850|NCT01275170|Secondary|Part 1: Ceoi of Cilastin in Combination With MK-7655|Cilastin is 1 of the 2 constituents of PRIMAXIN®. Ceoi is the observed plasma drug concentration at the end of IV infusion.|At 0.5 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||µM||95% Confidence Interval|Geometric Mean
2695851|NCT01275170|Secondary|Part 1: AUC0-inf of Cilastin in Combination With MK-7655|Cilastin is 1 of the 2 constituents of PRIMAXIN®. AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||µM*hr||95% Confidence Interval|Geometric Mean
2695852|NCT01275170|Secondary|Part 1: Apparent t½ of Imipenem in Combination With MK-7655|Imipenem is 1 of the 2 constituents of PRIMAXIN®. Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2695853|NCT01275170|Secondary|Part 1: Tmax of Imipenem in Combination With MK-7655|Tmax is the time at which the highest plasma drug concentration was observed.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||hours||Full Range|Median
2695854|NCT01275170|Secondary|Part 1: VZpred of Imipenem in Combination With MK-7655|Imipenem is 1 of the 2 constituents of PRIMAXIN®. VZpred is the predicted volume of distribution during the terminal phase.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||liters (L)||95% Confidence Interval|Geometric Mean
2695855|NCT01275170|Secondary|Part 1: CLpred of Imipenem in Combination With MK-7655|Imipenem is 1 of the 2 constituents of PRIMAXIN®. CLpred is the predicted apparent total body clearance of drug.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||mL/min||95% Confidence Interval|Geometric Mean
2695856|NCT01275170|Secondary|Part 1: Ceoi of Imipenem in Combination With MK-7655|Imipenem is 1 of the 2 constituents of PRIMAXIN®. Ceoi is the observed plasma drug concentration at the end of IV infusion.|At 0.5 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||µM||95% Confidence Interval|Geometric Mean
2695857|NCT01275170|Secondary|Part 1: AUC0-inf of Imipenem in Combination With MK-7655|Imipenem is 1 of the 2 constituents of PRIMAXIN®. AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||µM*hr||95% Confidence Interval|Geometric Mean
2695858|NCT01275170|Secondary|Part 1: Apparent Plasma Half-life (t½) of MK-7655 in Combination With PRIMAXIN®|Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2695859|NCT01275170|Secondary|Part 1: Time of Maximum Plasma Concentration (Tmax) of MK-7655 in Combination With PRIMAXIN®|Tmax is the time at which the highest plasma drug concentration was observed.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||hours||Full Range|Median
2695860|NCT01275170|Secondary|Part 1: Predicted Volume of Distribution During the Terminal Phase (VZpred) of MK-7655 in Combination With PRIMAXIN®|VZpred is the predicted volume of distribution during the terminal phase.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||liters (L)||95% Confidence Interval|Geometric Mean
2695861|NCT01275170|Secondary|Part 1: Predicted Clearance (CLpred) of MK-7655 in Combination With PRIMAXIN®|CLpred is the predicted apparent total body clearance of drug.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||mL/min||95% Confidence Interval|Geometric Mean
2695862|NCT01275170|Secondary|Part 1: Concentration at End of Infusion (Ceoi) of MK-7655 in Combination With PRIMAXIN®|Ceoi is the observed plasma drug concentration at the end of IV infusion.|At 0.5 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||µM||95% Confidence Interval|Geometric Mean
2695863|NCT01275170|Primary|Part 1: Area Under the Plasma Concentration-time Curve From Dosing to Infinity (AUC0-inf) of MK-7655 in Combination With PRIMAXIN®|AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.|Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose|Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.|||µM*hr||95% Confidence Interval|Geometric Mean
2695864|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Self-rated Calmness|"The participant was required to rate how they felt at this moment on sixteen 10 centimeter visual analogue scales. The scale endpoints were anchored using polar word pairs such as 'drowsy-alert', 'clumsy-well coordinated', 'mentally slow-quick witted' and 'incompetent-proficient'. Responses from the 16 scales were scored to yield 3 main factors: Self-rated Alertness, Self-rated Contentment, and Self-rated Calmness. The possible range of scores are 0 to 100 for each factor and are represented in millimeters on the 10 centimeter line with higher numbers indicating greater calmness. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||millimeters (mm)|observations|Standard Error|Least Squares Mean
2695865|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Self-rated Contentment|"The participant was required to rate how they felt at this moment on sixteen 10 centimeter visual analogue scales. The scale endpoints were anchored using polar word pairs such as 'drowsy-alert', 'clumsy-well coordinated', 'mentally slow-quick witted' and 'incompetent-proficient'. Responses from the 16 scales were scored to yield 3 main factors: Self-rated Alertness, Self-rated Contentment, and Self-rated Calmness. The possible range of scores are 0 to 100 for each factor and are represented in millimeters on the 10 centimeter line with higher numbers indicating greater contentment. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3||||millimeters (mm)|observations|Standard Error|Least Squares Mean
2695866|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Self-rated Alertness|"The participant was required to rate how they felt at this moment on sixteen 10 centimeter visual analogue scales. The scale endpoints were anchored using polar word pairs such as 'drowsy-alert', 'clumsy-well coordinated', 'mentally slow-quick witted' and 'incompetent-proficient'. Responses from the 16 scales were scored to yield 3 main factors: Self-rated Alertness, Self-rated Contentment, and Self-rated Calmness. The possible range of scores are 0 to 100 for each factor and are represented in millimeters on the 10 centimeter line with higher numbers indicating greater alertness. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||millimeters (mm)|observations|Standard Error|Least Squares Mean
2695867|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Postural Stability|"The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway.~The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||1/3 degree of angle of sway|observations|Standard Error|Least Squares Mean
2695868|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Tracking Average Distance From Target|The participant used a joystick to track a randomly moving target on the computer screen. The distance from the target was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||millimeters (mm)|observations|Standard Error|Least Squares Mean
2695869|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Picture Recognition Speed|The original pictures from Picture Presentation plus 20 distractor pictures were presented one at a time. For each picture, the participant was required to indicate whether they recognized it from the original series of pictures by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following the response, there was a delay of 1 second before the next pictures was presented. The time required to press the corresponding 'Yes' or 'No' response button in response to the picture was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||milliseconds (msec)|observations|Standard Error|Least Squares Mean
2695870|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Picture Recognition Sensitivity Index (SI)|"Picture Recognition SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). Higher SI indicates better cognitive function. A negative change from baseline reflects impairment compared to baseline.~The original pictures from Picture Presentation plus 20 distractor pictures were presented one at a time. For each picture, the participant was required to indicate whether they recognized it from the original series of pictures by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following the response, there was a delay of 1 second before the next pictures was presented. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||Sensitivity Index|observations|Standard Error|Least Squares Mean
2695942|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695871|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Word Recognition Speed|The original words from Word Presentation plus 15 distractor words were presented one at a time in a randomized order. For each word, the participant was required to indicate whether they recognized it from the original list of words by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following each response, there was a delay of 1 second before the next word was presented. The time required to press the corresponding 'Yes' or 'No' response button in response to the word was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||milliseconds (msec)|observations|Standard Error|Least Squares Mean
2695872|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Word Recognition Sensitivity Index (SI)|"Word Recognition SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). Higher SI indicates better cognitive function. A negative change from baseline reflects impairment compared to baseline.~The original words from Word Presentation plus 15 distractor words were presented one at a time in a randomized order. For each word, the participant was required to indicate whether they recognized it from the original list of words by pressing the corresponding 'Yes' or 'No' button as quickly as possible. Following each response, there was a delay of 1 second before the next word was presented. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||Sensitivity Index (SI)|observations|Standard Error|Least Squares Mean
2695873|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Delayed Word Recall Errors|The participant was given a series of words to commit to memory. After a delay, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The number of incorrect words was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||number of words incorrectly recalled|observations|Standard Error|Least Squares Mean
2695874|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Delayed Word Recall Accuracy|The participant was given a series of words to commit to memory. After a delay of approximately 15-20 minutes, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The percentage of words correctly recalled (present on the original list of words) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||percentage of words correctly recalled|observations|Standard Error|Least Squares Mean
2695875|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Immediate Word Recall Errors|The participant was given a series of words to commit to memory. Immediately after the last word was presented, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The number of words incorrectly recalled (not on the original list of words) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||number of words incorrectly recalled|observations|Standard Error|Least Squares Mean
2695876|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Immediate Word Recall Accuracy|The participant was given a series of words to commit to memory. Immediately after the last word was presented, the participant was given 1 minute to write as many of the words as possible in any order on a sheet of paper. The percentage of words correctly recalled (present on the original list of words) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||percentage of words correctly recalled|observations|Standard Error|Least Squares Mean
2695877|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Numeric Working Memory Speed|A series of 5 digits were presented on a computer screen, one every 1.15 seconds, for the participant to hold in memory. This was followed by a series of 30 probe digits for each of which the participant had to decide whether it had appeared in the original series of digits and press the corresponding 'Yes' or 'No' response button as quickly as possible. This procedure was repeated a further 2 times using 2 different series and probes. The time required to press the corresponding 'Yes' or 'No' response button in response to the probe digit is presented. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||milliseconds (msec)|observations|Standard Error|Least Squares Mean
2695878|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Numeric Working Memory Sensitivity Index (SI)|"Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks (sensitivity index [SI]). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline.~A series of 5 digits were presented on a computer screen, one every 1.15 seconds, for the participant to hold in memory. This was followed by a series of 30 probe digits for each of which the participant had to decide whether it had appeared in the original series of digits and press the corresponding 'Yes' or 'No' response button as quickly as possible. This procedure was repeated 2 times using 2 different series and probes. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time."|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||Sensitivity Index (SI)|observations|Standard Error|Least Squares Mean
2695879|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Choice Reaction Time Accuracy|Participants were required to respond to the words 'Yes' and 'No' as they appeared on the computer screen by pressing the corresponding button as quickly as possible. There were 50 trials during which each stimulus word was chosen randomly with equal probability; there was a varying inter-stimulus interval of between 1 and 3.5 seconds. The percentage of correct responses was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||percentage of correct responses|observations|Standard Error|Least Squares Mean
2695880|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Choice Reaction Time|Participants were required to respond to the words 'Yes' and 'No' as they appeared on the computer screen by pressing the corresponding button as quickly as possible. There were 50 trials during which each stimulus word was chosen randomly with equal probability; there was a varying inter-stimulus interval of between 1 and 3.5 seconds. The time required to respond was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||millisecond (msec)|observations|Standard Error|Least Squares Mean
2695881|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Digit False Alarms|A target digit was pseudo-randomly selected and constantly displayed to the right of the computer screen. A series of digits were then presented in the center of the computer screen at the rate of 150 per minute. The participant was required to press the 'Yes' button as quickly as possible every time a digit in the series matched the target digit. There were 45 targets. The number of false alarms (incorrect 'Yes' responses) was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||Number of false alarms|observations|Standard Error|Least Squares Mean
2695882|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Digit Vigilance Speed|A target digit was pseudo-randomly selected and constantly displayed to the right of the computer screen. A series of 450 digits was then presented in the center of the computer screen at the rate of 150 per minute. The participant was required to press the 'Yes' button as quickly as possible every time a digit in the series matched the target digit. There were 45 targets. Speed at which a participant detected target digits was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||millisecond (msec)|Observations|Standard Error|Least Squares Mean
2695883|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Digit Vigilance Targets Detected|A target digit was pseudo-randomly selected and constantly displayed to the right of the computer screen. A series of 450 digits was then presented in the center of the computer screen at the rate of 150 per minute. The participant was required to press the 'Yes' button as quickly as possible every time a digit in the series matched the target digit. There were 45 targets. Percentage of target digits correctly detected was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||percentage of digits correctly detected|Obsevations|Standard Error|Least Squares Mean
2695884|NCT01275144|Secondary|Change From Baseline in Cognitive Function-Simple Reaction Time|Participants were instructed to press the 'Yes' response button as quickly as possible every time the word 'Yes' was presented on the computer screen. Fifty stimuli were presented with a varying inter-stimulus interval of between 1 and 3.5 seconds. Participant's reaction time to the stimulus was measured. Participant's response was measured twice. Least squares means were adjusted for baseline, period, sequence, time, treatment and treatment*time.|Baseline, 2, 4, 8 hours on Day 3|All enrolled participants|||millisecond (msec)|observations|Standard Error|Least Squares Mean
2695885|NCT01275144|Primary|Pharmacokinetics of Lorazepam, Area Under the Plasma Concentration Curve (AUC) From Time 0 to Infinity (∞)|The geometric least squares mean and 90% Confidence Interval are presented. Geometric least squares mean corrected for participant, treatment and random error.|Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post lorazepam dose|All enrolled participants|||nanograms*hour per milliliter (ng*h/mL)||90% Confidence Interval|Least Squares Mean
2695886|NCT01275144|Primary|Pharmacokinetics of Lorazepam, Time to Maximum Plasma Concentration (Tmax)||Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post lorazepam dose|All enrolled participants|||hours||90% Confidence Interval|Median
2695887|NCT01275144|Primary|Pharmacokinetics of Lorazepam, Maximum Plasma Concentration (Cmax)|The geometric least squares mean and 90% Confidence Interval are presented. Geometric least squares mean corrected for participant, treatment and random error.|Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post lorazepam dose|All enrolled participants.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
2695888|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.|||ratio||Standard Deviation|Mean
2695889|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.|||Ratio||Standard Deviation|Mean
2695890|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.|||Picomoles*minutes/liter||Standard Deviation|Mean
2695891|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1|Area under the glucose concentration curve for 0 to 360 minutes (AUC[0-360]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.|||Picomoles*minutes/liter||Standard Deviation|Mean
2695892|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 3|Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.|||Minutes||Standard Deviation|Mean
2695893|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 1|Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.|||Minutes||Standard Deviation|Mean
2695894|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3|Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable early and late tGIR50%max data.|||Minutes||Standard Deviation|Mean
2695895|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1|Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable early or late tGIR50%max data.|||Minutes||Standard Deviation|Mean
2695896|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.|||Minutes||Standard Deviation|Mean
2695897|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.|||Minutes||Standard Deviation|Mean
2695898|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 3|Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable GIRmax data.|||Milligrams/kilogram/minute||Standard Deviation|Mean
2695899|NCT01275131|Primary|Early Exposure to Insulin (%AUC[0-60]), Stage 3|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable %AUC(0-60) data.|||Percentage of AUC(0-360)||Standard Deviation|Mean
2695900|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 1|Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable GIRmax data.|||Milligrams/kilogram/minute||Standard Deviation|Mean
2695901|NCT01275131|Primary|Early Insulin Exposure (%AUC[0-60]), Stage 1|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose|Participants who completed all study periods within a given stage with evaluable early insulin exposure (%AUC[0-60]) data.|||Percentage of AUC(0-360)||Standard Deviation|Mean
2695902|NCT01275092|Secondary|The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table|Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.|1 day||||ratio||Inter-Quartile Range|Median
2695903|NCT01275092|Primary|Percentage of Patients With Device Technical Success|Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.|1 day||||percentage of participants||95% Confidence Interval|Number
2695904|NCT01275092|Primary|Percentage of Participants With Clinical Procedural Success|Defined as <30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.|48-hrs or hospital discharge, whichever occurs first||||percentage of participants||95% Confidence Interval|Number
2695905|NCT01275066|Secondary|Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Nine missing outcomes at Week 24 were imputed using method of multiple imputation.|||percent change||Standard Deviation|Mean
2695906|NCT01275066|Secondary|Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.|||stairs/minute||Standard Deviation|Mean
2695908|NCT01275053|Primary|Leptin Signaling|"Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration.~The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration.~The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration."|Baseline and 30 minutes|All subjects received biopsies before and 30 min after leptin administration.|||fold change||Full Range|Mean
2695909|NCT01274897|Secondary|Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination||during 7 days of vaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.|||Subjects|||Number
2695910|NCT01274897|Secondary|Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.|||Percentages of subjects||95% Confidence Interval|Number
2695911|NCT01274897|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.|||Titers||95% Confidence Interval|Geometric Mean
2695912|NCT01274897|Primary|Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).~Seroresponse is defined as:~for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.~for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer."|day 29|Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.|||Percentages of subjects||95% Confidence Interval|Number
2695913|NCT01274715|Primary|Change in Hemoglobin A1C|Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|baseline, 3 months, and 6 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
2695914|NCT01274715|Primary|Change in PHQ-9 (Patient Health Questionnaire-9)Scores|The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|Baseline, 3 months, and 6 months||||scores on a scale||Standard Deviation|Mean
2695915|NCT01274637|Secondary|Heparin Induced Thrombocytopenia|All subjects who develop thrombocytopenia (platelets less than 80 x 109/L and/or with >50% decrease from baseline) will be investigated for Heparin Induced Thrombocytopenia (HIT) by having ELISA and serotonin release assays to confirm or refute a diagnosis of HIT. HIT will be diagnosed with a positive PF4 (platelet factor 4) HIT ELISA assay.|From Randomization to Day 90||||Participants|||Count of Participants
2695916|NCT01274637|Secondary|Major Bleeding or Clinically Relevant Non-major Bleeding|"Major bleeding meets at least one of the following: Fatal bleeding; Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, retroperitoneal, etc.); Bleeding causing a fall in hemoglobin level of 20 g L−1 (1.24 mmol L−1) or more, or leading to transfusion of two or more units of whole blood or red cells .~Clinically Relevant Non-major Bleeding does not meet the criteria for major bleeding but meets at least one of the following: Hospitalization; Medical intervention; Unscheduled contact with a physician; Discomfort (pain, or impairment of activities of daily life)."|From Randomization to Day 90||||Participants|||Count of Participants
2695917|NCT01274637|Secondary|Death From Venous Thromboembolism|"If a subject dies between randomization and late postpartum follow up (Day 90 +/- 7 days) the death will be adjudicated as certain, highly probable, probable, or unlikely due to Pulmonary Embolism (PE) using the following criteria.~Certain: hypotension, hypoxia, cardiac arrest with no other explanation other than PE and autopsy or radiographic confirmation Highly probable: criteria for certain but another disease could have caused the death Probable: other cause suspected based on clinical evidence but 100% certainty not available Unlikely: all other cases."|From Randomization to Day 90||||Participants|||Count of Participants
2695918|NCT01274637|Secondary|Late Symptomatic Venous Thromboembolism|This includes symptomatic Deep Vein Thrombosis or Pulmonary Embolism. Suspected outcomes will be adjudicated by a blinded adjudication committee.|From Day 10 to Day 90||||Participants|||Count of Participants
2695919|NCT01274637|Secondary|Venous Thromboembolism in the Early Postpartum Period.|This includes symptomatic Deep Vein Thrombosis (DVT) or pulmonary embolism (PE) in the interval between randomization and the last dose of study drug (10 days +/- 3 days) OR asymptomatic proximal DVT detected by compression ultrasound of both legs done within 24hrs of the last dose of study drug (10 days (+/- 3 days) postpartum). Compressed and non-compressed images will be obtained from the calf trifurcation to the inguinal ligament. All suspected outcomes will be adjudicated by a blinded expert adjudication committee.|From randomization to Day 10||||Participants|||Count of Participants
2695920|NCT01274637|Primary|Feasibility of Recruitment and Trial Operations.|The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site.|4 months||||participants per site per month|||Number
2695943|NCT01274559|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695921|NCT01274611|Primary|Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months|"The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment.~This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes.~Percentage sweat rate was calculated as [(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline]*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate."|baseline and 3 months||||Percentage Change|Participants|Full Range|Mean
2695922|NCT01274611|Secondary|The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment|"Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment.~The HDSS iquestionnaire assigns a point value to the patient's view:~My sweating is...~never noticeable and never interferes with my daily activities~tolerable but sometimes interferes with my daily activities~barely tolerable and frequently interferes with my daily activities~intolerable and always interferes with my daily activities~Lower point values are considered better and higher point values are considered worse.~A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment."|Baseline and 3 months||||Scores on a scale|Participants|Standard Deviation|Mean
2695923|NCT01274585|Secondary|Change in Fecal Incontinence Quality of Life (FIQoL) Score|The Fecal incontinence Quality of Life (FIQoL) score evaluates how fecal incontinence impacts the subjects quality of life. The scale ranges from 37 to 159 where the higher the score, the better the quality of life associated with symptoms.|12 weeks|Only 4 of the 5 subjects completed questionnaires at the completion of the trial. Therefore, these were the only subjects included in analysis.|||mean score||Full Range|Mean
2695924|NCT01274585|Secondary|Change in Fecal Incontinence Severity Index (FISI) Score|Fecal Incontinence Severity Index (FISI) is a tool used to stratify severity of fecal incontinence in the subjects. The range of score is from 0 to 61 where the higher score correlates with more severe symptoms of incontinence.|12 weeks|Only 4 of the 5 subjects completed questionnaires at the completion of the trial. Therefore, these were the only subjects included in analysis.|||mean score||Full Range|Mean
2695925|NCT01274585|Primary|Frequency of Fecal Incontinence|Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.|Diary kept for 14 days following treatment||||number of accidents||Full Range|Mean
2695926|NCT01274559|Secondary|Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment|assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines|Baseline and 12 weeks|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695927|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695928|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695929|NCT01274559|Secondary|Percent Change From Baseline in Lp(a) at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695930|NCT01274559|Secondary|Percent Change From Baseline in TC:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695931|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695932|NCT01274559|Secondary|Percent Change From Baseline in Apo B at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695933|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695934|NCT01274559|Secondary|Percent Change From Baseline in TG at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695935|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695936|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695937|NCT01274559|Secondary|Percent Change From Baseline in LDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695938|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695939|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695940|NCT01274559|Secondary|Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695941|NCT01274559|Secondary|Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2695949|NCT01274533|Secondary|Safety of Lenalidomide Monotherapy||28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.||||||
2695950|NCT01274533|Primary|Response Rate (CR + Cru + PR)|Peripheral blood, CT or MRI|28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.||||||
2695951|NCT01274429|Secondary|Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.|Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells|2-3 years|No subjects reached the end of study prior to closure of the study and therefore no end of treatment mechanistic data was collected in order to compare against the baseline.||||||
2695952|NCT01274429|Primary|Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.|Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance|2-3 years|No subjects reached the end of study food challenge prior to closure of the study and therefore no data was collected towards this endpoint.||||||
2695953|NCT01274182|Other Pre-specified|Number of Patients With at Least One Anti-Drug-Antibody (ADA) Positive Serum Sample|Number of patients with at least one post-baseline Anti-Drug-Antibody (ADA) positive serum sample until the last study visit. Sampling was at Day 1, 29, 113, 169, 267, 365, optional visit 1 (could be at any time between day 169 - week 24 and day 365 - week 52 for patients, who received a 2nd treatment course) and optional visit 2 (only applicable for patients, who received a 2nd treatment course, 26 weeks thereafter, if this was after day 365 - week 52).|through study completion, an average of 1 year|Patients with positive ADA results at randomization were excluded from analysis|||participants|||Number
2695954|NCT01274182|Secondary|Participant Response as Assessed by EULAR Response Criteria|"Present DAS28 ≤ 3.2 (low): good response (if improvement > 1.2), moderate response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).~Present DAS28 > 3.2 to ≤ 5.1 (moderate): moderate response (if improvement > 1.2), moderate response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).~Present DAS28 > 5.1 (high): moderate response (if improvement > 1.2), no response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6)."|At week 24|PP analysis set|||Participants|||Count of Participants
2695955|NCT01274182|Secondary|Summary of Disease Activity According to SDAI|"In order to calculate the Simplified Disease Activity Index (SDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient's global assessment of disease activity and the physician's global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst).~SDAI = CDAI + CRP (in mg/dL)~(CDAI = tender28 + swollen28 + patient's global assessment (in cm) + physician's global assessment (in cm))"|At week 24|PP analysis set|||Participants|||Count of Participants
2695956|NCT01274182|Secondary|Summary of Disease Activity According to CDAI|"In order to calculate the Clinical Disease Activity Index (CDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient's global assessment of disease activity and the physician's global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst).~CDAI = tender28 + swollen28 + patient's global assessment (in cm) + physician's global assessment (in cm)"|At week 24|PP analysis set|||Participants|||Count of Participants
2695957|NCT01274182|Secondary|Number of Patients With ACR20 (CRP) Response|"A patient will be considered as improved according the ACR20 criteria~at least 20 % improvement from baseline in tender joint count, using the 68-joint count~at least 20 % improvement from baseline in swollen joint count, using the 66-joint count~and at least 20% improvement from baseline in a least 3 of the following 5 measures:~Patient's assessment of RA pain (VAS 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire disability index)~Acute phase reactant (C-reactive protein or erythrocyte sedimentation rate)"|24 weeks|PP analysis set|||Participants|||Count of Participants
2695958|NCT01274182|Secondary|Change From Baseline in DAS28(CRP) at Week 24|"Change from baseline in Disease Activity Score 28 joint count - C-reactive proteine DAS28(CRP) at Week 24.~In order to calculate the DAS28(CRP) the number of tender joints and swollen joints were assessed using 28-joint count (tender28 and swollen28).The patient's global assessment of disease activity (GH) measured on a Visual Analogue Scale (VAS from 0mm - best to 100mm - worst) was obtained.~DAS28(CRP) = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GH + 0.96 The DAS28(CRP) provides a number on a scale from 0 to 10 indicating the current activity of the RA, while lower values correspond with less disease activity. A decrease in DAS28 signifies a clinical improvement."|24 weeks|PP analysis set|||units on a scale||Standard Error|Least Squares Mean
2695959|NCT01274182|Secondary|Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA|Area under the effect curve of percent change of peripheral B-cell count from baseline to Day 14 (AUEC(0-14d)) of GP2013, MabThera and Rituxan in patients with RA|14 days|PK analysis set|||% * day||Geometric Coefficient of Variation|Geometric Mean
2695960|NCT01274182|Secondary|Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA|Maximum serum concentration (Cmax) after the first infusion of GP2013, MabThera and Rituxan in patients with RA. Samples collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169.|From baseline to week 24|PK Analysis Set|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2695961|NCT01274182|Primary|AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA|Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169|From baseline to 24 weeks|PK Analysis Set|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2696852|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 4|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 4|Participants with available data at given time points.|||ng/mL||Standard Deviation|Mean
2695962|NCT01273896|Primary|Overall Response Rate|To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response|Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle||||participants|||Number
2695963|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all the female subjects completed the THI questionnaire.|||units on a scale||Standard Deviation|Mean
2695964|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all male subjects completed the THI questionnaire.|||units on a scale||Standard Deviation|Mean
2695965|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the THI questionnaire.|||units on a scale||Standard Deviation|Mean
2695966|NCT01273883|Primary|Tinnitus Distress Rating|This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the distress rating scale.|||units on a scale||Standard Deviation|Mean
2695967|NCT01273857|Secondary|Serious Adverse Events|The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.|3 months to 1 year after cell transplantation||||participants|||Number
2695968|NCT01273857|Primary|Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells|"Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.~The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards."|3 months to 1 year after cell transplantation||||participants|||Number
2695969|NCT01273818|Primary|Number of Infections in Each Study Arm|Patients were examined on postoperative 30 days for the presence of surgical site infection.|within the 30 days after surgery||||infections|||Number
2695970|NCT01273818|Primary|Rate of Post-operative Infection||within the first 30 days after surgery|||||||
2695971|NCT01273805|Secondary|Grade 4-5 Treatment-Related Toxicity|All grade 4-5 adverse events with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms.|Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2695972|NCT01273805|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to time of objective progression on CT scan or the time of death for patients with clinical deterioration resulting in withdrawal from the trial. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients without an event were censored at date of last disease evaluation.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61).|The analysis dataset is comprised of all enrolled patients.|||days||95% Confidence Interval|Median
2695973|NCT01273805|Secondary|Overall Survival|Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death or date last known alive.|All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184).|The analysis dataset is comprised of all enrolled patients.|||days||95% Confidence Interval|Median
2695974|NCT01273805|Secondary|Tumor Response Rate|Tumor response rate is the percentage of patients achieving complete or partial response on treatment based on RECIST 1.0 criteria. For target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR for the evaluation of non-target lesions is the disappearance of non-target lesions and normalization of tumor marker level. Appearance of one or more new lesions is classified as progression of non-target lesions. CR or PR confirmation is required >/= 4 weeks.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.|The analysis dataset is comprised of all enrolled patients.|||percentage of patients|||Number
2695975|NCT01273805|Secondary|Biochemical Response Rate|Biochemical response rate was defined as the percentage of patients achieving on treatment a decrease in serum CA 19-9 by > 30% from baseline.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.|Biochemical response could not be estimated due to insufficient longitudinal CA 19-9 measurements. This was directly related to the observed lack of activity of the study drug and corresponding short duration of therapy.||||||
2707703|NCT01189604|Secondary|Blood Concentrations of Propofol|Blood concentration of ICI35,868 (propofol)|At the end of the initiation period and every 2 minutes during the maintenance period||||µg/mL||Standard Deviation|Mean
2695976|NCT01273805|Primary|2-month Progression-Free Survival Rate|2-month progression-free survival rate was defined as the percentage of patients absent progression (PD) or death before 2 months. Patients were considered to have experienced PD if they demonstrated either clinical deterioration resulting in withdrawal or PD per RECIST 1.0 criteria: At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and at the first restaging at 2 months.|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||95% Confidence Interval|Number
2695977|NCT01273766|Secondary|Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months||||Participants|||Count of Participants
2695978|NCT01273766|Secondary|Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months|Number analyzed in rows differs from overall because data was not collected on all participants.|||Participants|||Count of Participants
2695979|NCT01273766|Primary|Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)|Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)|Baseline, up to 6 months||||10^9 Neutrophils per Liter||Standard Deviation|Mean
2695980|NCT01273623|Secondary|Residual Diameter Stenosis|lumen diameter stenosis change post-atherectomy|Day 0||||percentage change||Standard Deviation|Mean
2695981|NCT01273623|Secondary|Adjunctive Therapy Use||Day 0||||percentage of participants|||Number
2695982|NCT01273623|Primary|Luminal Area Change|lumen area change as measured by intravascular ultrasound (IVUS)|Day 0||||mm^2||Standard Deviation|Mean
2695983|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.|||participants|||Number
2695984|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy|Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data|||participants|||Number
2695985|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.|||participants|||Number
2695986|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy|Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data|||participants|||Number
2695987|NCT01273597|Secondary|Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism|If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.||||||
2695988|NCT01273597|Secondary|Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance|If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.||||||
2695989|NCT01273597|Secondary|Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance|If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.||||||
2695990|NCT01273597|Secondary|Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6|Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|All participants|||participants|||Number
2695991|NCT01273597|Primary|Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)|Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|Participants who achieved maintenance dose of Zemplar (paricalcitol injection)|||weeks||Standard Deviation|Mean
2695992|NCT01273519|Primary|Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.|Baseline, Month 12|All participants with an assessment.|||participants|||Number
2695993|NCT01273519|Secondary|Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12|The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||mg/dL||Standard Deviation|Mean
2695994|NCT01273519|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12|The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||mm/h||Standard Deviation|Mean
2695995|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12|The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2695996|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12|"The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible) is used to answer the questions on the test."|Baseline, Months 3, 6, 9, 12|Participants with AS or PsA and an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2695997|NCT01273519|Secondary|Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12|The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2695998|NCT01273519|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2695999|NCT01273519|Secondary|Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2696000|NCT01273519|Primary|Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12|Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.|Baseline, Month 12|All participants with an assessment.|||participants|||Number
2696001|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.|||participants|||Number
2696002|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.|||participants|||Number
2696003|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12|"Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question How intensive was your pain on average in the past 3 months? on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain."|Baseline, Month 12|All participants with an assessment.|||participants|||Number
2696004|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2696005|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12|"Participants measured their present pain intensity by specifying their level of pain in response to the question How intensive is your pain at present? on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain."|Baseline, Month 12|All participants with an assessment at time point.|||participants|||Number
2696006|NCT01273519|Primary|Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2696007|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2696008|NCT01273181|Primary|Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer|Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years||||Participants|||Number
2696009|NCT01273181|Primary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|2 years||||Participants|||Number
2696010|NCT01273155|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0).|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|From Cycle 1 Day -7 up to 12 (21-day) cycles.||||Participants|||Count of Participants
2696011|NCT01273155|Secondary|Best Response|Radiologic response assessments by computed tomography (CT) scans were performed at baseline and every two cycles of treatment based on the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Per RECIST v1.1 Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD), neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for Progression of Disease (PD), taking as reference the smallest sum diameters while on study; PD, >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and an absolute increase of at least 5mm or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.|at baseline and every two 21-day cycles of treatment, up to 12 cycles|Patients were considered evaluable for response if they received at least one cycle of therapy and had their disease re-evaluated with a restaging scan, or exhibited objective disease progression prior ot the end of Cycle 1 but after receiving all Cycle 1 doses.|||Participants|||Count of Participants
2696012|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Metabolic Ratios of Area Under the Plasma Concentration Time Curve Extrapolated to Infinity (AUC0-inf) for the Belinostat Metabolic Pathway|Metabolic ratios of Area Under the Plasma Concentration Time Curve Extrapolated to Infinity (AUC0-inf), reported as geometric mean (geometric standard deviation), for the belinostat metabolic pathway on Cycle 1 Day-7 as a function of degree of liver dysfunction.|Cycle 1 Day-7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinistat on Cycle 1 Day-7 and had blood samples successfully collected at the specified timepoints for PK analysis. One patient with Mild Liver Dysfunction was not evaluable for Belinostat AUC0-inf.|||ratio||Standard Deviation|Geometric Mean
2696013|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Metabolic Ratios of Maximum Plasma Concentrations (Cmax) for the Belinostat Metabolic Pathway|Metabolic ratios of Maximum Plasma Concentrations (Cmax), reported as a geometric mean (geometric standard deviation), for the belinostat metabolic pathway on Cycle 1 Day-7 as a function of degree of liver dysfunction.|Cycle 1 Day-7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinistat on Cycle 1 Day-7 and had blood samples successfully collected at the specified timepoints for PK analysis. There were 3 patients with Mild Liver Dysfunction who were not evaluable for Belinostat Cmax.|||ratio||Standard Deviation|Geometric Mean
2696014|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Volume of Distribution at Steady State (Vss)|Belinostat Apparent volume of distribution at steady state (Vss) on Cycle 1 Day-7 as a function of degree of liver dysfunction.|Cycle 1 Day-7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinistat on Cycle 1 Day-7 and had blood samples successfully collected at the specified timepoints for PK analysis.|||L/m^2||Standard Deviation|Mean
2696015|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Clearance (CL)|Clearance (CL) of Belinostat on Cycle 1 Day-7 as a function of degree of liver dysfunction|Cycle 1 Day-7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinistat on Cycle 1 Day-7 and had blood samples successfully collected at the specified timepoints for PK analysis.|||mL/min/m^2||Standard Deviation|Mean
2696016|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Half-Life (t1/2)|Half-life Period (t1/2) of belinostat and five metabolites on Cycle 1 Day -7 as a function of degree of liver function.|Cycle 1 Day -7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinostat on Cycle 1 Day -7 and had blood samples successfully collected at the specified timepoints for PK analysis.|||min||Standard Deviation|Mean
2696017|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Area Under the Plasma Concentration Time Curve Extrapolated to Infinity(AUC0-inf) of Belinostat|Area Under the Plasma Concentration Time Curve Extrapolated to Infinity(AUC0-inf) for Belinostat glucuronide, a Belinostat Metabolite on Cycle 1 Day-7 as a function of degree of liver dysfunction.|Cycle 1 Day -7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinostat on Cycle 1 Day -7 and had blood samples successfully collected at the specified timepoints for PK analysis.|||mg*min/mL||Standard Deviation|Mean
2696018|NCT01273155|Primary|Pharmacokinetics (PK) of Single-dose Belinostat (400 mg/m^2) According to Degree of Liver Dysfunction: Area Under the Plasma Concentration Time Curve Extrapolated to Infinity(AUC0-inf)|Area Under the Plasma Concentration Time Curve Extrapolated to Infinity (AUC0-inf) for belinostat and four metabolites on Cycle 1 Day -7 as a function of degree of liver dysfunction.|Cycle 1 Day-7 prior to infusion; 15 and 25 minutes after start of infusion; and 5, 10, 15, 60, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinostat on Cycle 1 day -7 and had blood samples successfully collected at the specified timepoints for PK analysis. One patient with Mild Liver Dysfunction was not evaluated for Belinostat AUC0-inf.|||µg*min/mL||Standard Deviation|Mean
2696019|NCT01273155|Primary|Pharmacokinetics (PK) of a Single-dose Belinostat (400 mg/m^2)) According to Degree of Liver Dysfunction: Maximum Plasma Concentrations (Cmax)|Maximum plasma concentrations (Cmax) for belinostat and five metabolites on Cycle 1 Day -7 as a function of degree of liver dysfunction.|Cycle 1 Day -7 prior to infusion; 15 and 25 minutes after the start of infusion; and 5, 10, 15, 30, 60, and 90 minutes, and 2, 4, 6, 8, and 24 hours after the end of infusion.|The number of patients in a given cohort that received Belinistat on Cycle 1 Day-7 and had blood samples successfully collected at the specified timepoints for PK analysis. There were 3 patients with Mild Liver Dysfunction who were not evaluable for Belinostat Cmax.|||µg/mL||Standard Deviation|Mean
2696020|NCT01273155|Primary|Number of Participants Experiencing Adverse Events Considered to be at Least Possibly Related to the Study Drug|The number of participants experiencing each adverse event by liver function cohort at each dose level. The grade refers to the severity of the Adverse Event. Grade 1 Mild; Grade 2 Moderate; Grade 3 Severe or medically significant but not immediately life-threatening; Grade 4 Life-threatening consequences; Grade 5 Death related to adverse event.|From Cycle 1 Day -7 up to 12 (21-day) cycles|Total number of evaluable patients per cohort on the indicated dose level; only patients who received study drug were evaluable for assessment of toxicity (some patients were assigned to a dose level but did not receive study drug and are therefore not included).|||Participants|||Count of Participants
2696021|NCT01273155|Primary|Maximum Tolerated Dose (MTD) of Belinostat According to Degree of Liver Dysfunction|In order to maintain consistent dosing across the hepatic dysfunction groups, the dose recommended for cohorts with greater liver dysfunction could be no greater than the dose for cohorts of lesser dysfunction. In other words, it was assumed that a particular group would not tolerate a dose not tolerated by a group with lesser dysfunction and conversely, will tolerate a dose tolerated by a group with greater dysfunction. If a higher dose was tolerated in a group of greater dysfunction, but not in the group of lesser dysfunction, the lower dose would be recommended for both groups. The highest dose to be explored was no greater than the recommended dose for patients with normal liver function.|First cycle of therapy, 28 days|Normal liver function patients were not eligible for dose escalation. Twenty-eight patients were evaluable for MTD; others came off study prior to the end of Cycle 1 and were not evaluable.|||mg/m(2)|||Number
2696022|NCT01273155|Primary|Dose Limiting Toxicity (DLTs)|A DLT was defined as an adverse event deemed possibly, probably, or definitely related to administration of study drugs and met the following criteria: grade≥3 non-hematological toxicity (except grade ≥3 diarrhea, nausea, vomiting responsive to supportive therapy);grade≥3 rise in creatinine (except grade 3 able to be corrected to grade 1 or baseline with intravenous fluids within 24hrs); grade≥3 electrolyte toxicities (except those able to be corrected to grade 1 or baseline within 48hrs); grade 4 thrombocytopenia; grade 4 neutropenia for >5 days or febrile neutropenia; any neurotoxicity grade≥2 not reversible to grade 1 or baseline within 2wks; or any delay in treatment by ≥2wks due to treatment-related toxicity. Worsening liver function, as defined by a rise in serum bilirubin not related to tumor progression, was considered a DLT if a patient with mild dysfunction became severe for 1wk, or if a patient in either the moderate/severe groups had a >1.5x increase in bilirubin for 1 wk.|First cycle of therapy, 28 days.|Forty patients were evaluable for dose-limiting toxicity; others came off study prior to the end of Cycle 1 and were not evaluable.|||Toxicities|||Number
2696023|NCT01273064|Secondary|Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48|"Percent of patients experiencing a drop in Hepatitis C virus ribonucleic acid (HCV-RNA, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 12, 24, and 48 weeks of treatment."|Baseline, and Study Weeks 12, 24, and 48|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.|||Percent of participants|||Number
2696024|NCT01273064|Primary|Sustained Virologic Response|Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.|Baseline and 24 weeks after the end of treatment (Week 72)|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.|||Percent of participants|||Number
2696025|NCT01273038|Primary|Frequency of Ballooning in the Morfeus and SenSura Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|ITT|||percentage of bags|Participants||Number
2696026|NCT01272960|Secondary|Intrauterine Infection|The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)|6 months||||participants|||Number
2696027|NCT01272960|Secondary|Uterine Perforation|The proportion of patients in each arm who experience a uterine perforation|6 months||||participants|||Number
2696028|NCT01272960|Secondary|Mirena Expulsion|The percentage of patients with post-placental placement of Mirena who experience an expulsion|6 weeks||||participants|||Number
2696029|NCT01272960|Primary|Mirena in Place|Proportion of women in each arm with Mirena in place at 6 months|6 months||||participants|||Number
2696030|NCT01272947|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|From randomization to end of day 1||||Hours||Inter-Quartile Range|Median
2696031|NCT01272947|Primary|Pain on Movement|"Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain"|VAS Score at 24 hours||||mm||Standard Deviation|Mean
2696032|NCT01272934|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|On day 1||||Hours||Inter-Quartile Range|Median
2696033|NCT01272934|Primary|Pain on Movement|"Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|72 hours||||mm||Standard Deviation|Mean
2696034|NCT01272921|Primary|Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL|Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL).|3 days||||Hours||95% Confidence Interval|Median
2696035|NCT01272921|Secondary|Cumulative Probabilities for Needle Positioning Above and Below CIEL.|The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.|1 Day||||Amplitude (mA)||95% Confidence Interval|Mean
2696036|NCT01272908|Secondary|Change From Baseline in FACIT-F Total Score During the Re-Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2696037|NCT01272908|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2696038|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
2696039|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
2696040|NCT01272908|Secondary|Change From Baseline CRP During the Re-Treatment Period|CRP levels were measured in mg/L and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
2696041|NCT01272908|Secondary|Change From Baseline in CRP During the Initial Treatment Period|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
2696042|NCT01272908|Secondary|Change From Baseline in ESR During the Re-Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2696043|NCT01272908|Secondary|Change From Baseline in ESR During the Initial Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2696044|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Re-Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determines the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if >2 categories were missing.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2696045|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Initial Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determined the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if > 2 categories were missing.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2696046|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2696047|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2696048|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2696049|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2696050|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2696077|NCT01272804|Secondary|Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15||Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696051|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm visual analog scale (VAS) where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2696052|NCT01272908|Secondary|Change From Baseline in TJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
2696053|NCT01272908|Secondary|Change From Baseline in TJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specific parameter at a given visit.|||tender joints||Standard Deviation|Mean
2696054|NCT01272908|Secondary|Change From Baseline in SJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given vist.|||swollen joints||Standard Deviation|Mean
2696055|NCT01272908|Secondary|Change From Baseline in SJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
2696056|NCT01272908|Secondary|Change From Baseline in DAS28 During the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2696057|NCT01272908|Secondary|Change From Baseline in DAS28 During the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2696058|NCT01272908|Secondary|Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
2696059|NCT01272908|Secondary|Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score less than or equal to [≤]3.2), moderate (DAS28 score greater than [>]3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
2696060|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
2696061|NCT01272908|Secondary|Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period|ACR20/50/70, defined as ≥20%, 50%, or 70% improvement, respectively, compared to baseline in TJC and SJC, and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; HAQ-DI; and an acute phase reactant (ESR or CRP). If CRP was missing or not done, then ESR was used.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
2703745|NCT01216397|Secondary|Assessment of Tolerability by the Investigator|Qualitative variable assessing the tolerability by the investigator|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
2696063|NCT01272908|Secondary|Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period|ACR20/50/70, defined as ≥20 percent (%), 50%, or 70% improvement, respectively, compared to baseline in tender joint count (TJC) and swollen joint count (SJC), and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and an acute phase reactant (erythrocyte sedimentation rate [ESR] or C-Reactive Protein [CRP]). If CRP was missing or not done, then ESR was used.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
2696064|NCT01272908|Secondary|Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary|Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Re-treatment period|ITT Population|||percentage of participants|||Number
2696065|NCT01272908|Primary|Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary|Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
2696066|NCT01272882|Primary|Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients|Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.|At the start of monitoring once the patient was consented and enrolled.||||Patients successfully monitored with EIT|||Number
2696067|NCT01272869|Primary|Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|Intention to treat (ITT)|||percentage bags with ballooning|Participants||Number
2696068|NCT01272830|Secondary|Deoxypyridinoline Levels|"The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrlinks-D enzyme-linked immunosorbent assay kits from R&D Systems(minneapolis, MN) and Metra Biosystems (Mountain View, CA) respectively.~Lower DPD concentrations represent a better outcome"|Baseline and 13 Weeks||||nmol/L||Standard Deviation|Mean
2696069|NCT01272830|Secondary|TGFBeta Levels|"The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrilinks-D enzyme-linked immunosorbent assay kits from R&D Systems (Minneapolis, MN) and Metra Biosystems (Mountain View, CA), respectively.~Lower TGFBeta concentrations represent a better outcome."|Baseline and 13 Weeks||||pg/mL||Standard Deviation|Mean
2696070|NCT01272830|Secondary|Surrogate Endpoint Markers (SEBs)|"HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.~Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor~Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (**this is an element of the HSS total)~Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor"|13 weeks||||units on a scale||Standard Deviation|Mean
2696071|NCT01272830|Primary|Pain Visual Analog Scale (VAS)|"Pain Visual Analog Scale (VAS)~Scale range (0-100) A higher VAS score indicate worse knee pain"|13-weeks||||units on a scale||Standard Deviation|Mean
2696072|NCT01272804|Secondary|Change From Baseline in Lactate Level at Day 6 and 14|Baseline value was collected at 0 hour on Day 1 for lactate.|Baseline (Day 1), Day 6 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696073|NCT01272804|Secondary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696074|NCT01272804|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696075|NCT01272804|Secondary|Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696076|NCT01272804|Secondary|Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696078|NCT01272804|Secondary|Change From Baseline in Average Plasma Glucose at Day 1, 6, 14|Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
2696079|NCT01272804|Secondary|Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||percent change||Standard Deviation|Mean
2696080|NCT01272804|Secondary|Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||percent change||Standard Deviation|Mean
2696081|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2696082|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)|Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.|||percent change||Standard Deviation|Mean
2696083|NCT01272804|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax)|Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2696084|NCT01272804|Primary|Observed Accumulation Ratio for AUCtau (Rac)|Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2696085|NCT01272804|Primary|Apparent Volume of Distribution (Vz/F) on Day 14|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2696086|NCT01272804|Primary|Apparent Oral Clearance (CL/F) on Day 14|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2696087|NCT01272804|Primary|Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14|Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.|0 hour (pre-dose) through 24 hours post-dose on Day 14|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of dose||Standard Deviation|Mean
2703885|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
2696088|NCT01272804|Primary|Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2696089|NCT01272804|Primary|Plasma Decay Half-Life (t1/2) on Day 14|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Standard Deviation|Mean
2696090|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14|AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2696091|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Full Range|Median
2696092|NCT01272804|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2696093|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1|AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2696094|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Full Range|Median
2696095|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2696096|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2696097|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)|Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2696098|NCT01272804|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2696099|NCT01272661|Secondary|Breastfeeding Rate at 6 Months Postpartum|Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum|ITT analysis conducted on participants with available data|||participants|||Number
2696100|NCT01272661|Secondary|Breastfeeding Rate at 3 Months Postpartum|Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum|ITT analysis conducted on participants with available data|||participants|||Number
2696101|NCT01272661|Secondary|Breastfeeding Rate at One Month Postpartum|Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.|Any and exclusive breastfeeding at one month, between 21-38 days postpartum|ITT analysis conducted on participants with available data|||participants|||Number
2696134|NCT01272245|Secondary|Disease-free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.||||Months||Full Range|Median
2696102|NCT01272661|Secondary|Breastfeeding Rate|Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.|Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours|ITT analysis was conducted on participants with available data|||participants|||Number
2696103|NCT01272661|Primary|Program Feasibility - Curriculum Modules|Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11|by 24 months from program start||||modules presented||Inter-Quartile Range|Mean
2696104|NCT01272661|Primary|Program Feasibility- Feeding Outcome Collected|Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome|by 24 months|Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period|||participants|||Number
2696105|NCT01272635|Secondary|Drug Related Side Effects|Parent-reported gastrointestinal symptoms during treated RTI.|14 days after initiation of therapy||||events|||Number
2696106|NCT01272635|Secondary|Urgent Care Visits, ED Visits and Hospitalizations|Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.|14 days after initiation of therapy|All participants who initiated APRIL therapy|||participants|||Number
2696107|NCT01272635|Secondary|Absence From School, Daycare, and/or Parental Work||14 days after initiation of therapy|Data were of insufficient quality to be analyzed.||||||
2696108|NCT01272635|Secondary|Asthma Related Symptoms Among RTI Progressing to Severe LRTI|Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.|14 days after initiation of therapy|Respiratory Tract Infections (RTI) progressing to Severe Lower RTI|||PAD score||Standard Deviation|Mean
2696109|NCT01272635|Primary|OCELOT: Pediatric Respiratory Assessment Measure|The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.|36-72 hours after initiation of OCELOT therapy|Participants who developed severe lower respiratory tract infections and initiate blinded OCELOT therapy.|||PRAM score||Standard Deviation|Mean
2696110|NCT01272635|Primary|Progression to Clinically Significant Lower Respiratory Tract Symptoms|Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.|14 days after initiation of APRIL therapy|All participants who initiated APRIL therapy|||participants|||Number
2696111|NCT01272583|Secondary|Symptomatic Hormone Responses to Acute Hypoglycaemia.|The symptomatic responses to hypoglycaemia were assessed using a standard validated symptom questionnaire adapted for experimental hypoglycaemia (McCrimmon et al (2003) Diabet.Med. 20: 507-509). A 7-point Likert scale (1=symptom absent; 7=symptom experienced with great intensity) was used to score presence and intensity of autonomic and neuroglycopenic symptoms of hypoglycaemia. Symptom scores were obtained during the initialisation phase, at occurrence of autonomic reaction and again 30 minutes later. For analyses the scale was considered as a continuous variable.|Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia||||units on a scale||Inter-Quartile Range|Median
2696112|NCT01272583|Secondary|Cortisol Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||mU*minutes/L||Inter-Quartile Range|Median
2696113|NCT01272583|Secondary|Growth Hormone Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||mU*minutes/L||Inter-Quartile Range|Median
2696114|NCT01272583|Secondary|Norepinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||nmol*minutes/L||Inter-Quartile Range|Median
2696115|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20 and 40 minutes||||pmol*minutes/L||Inter-Quartile Range|Median
2696116|NCT01272583|Secondary|Epinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||nmol*minutes/L||Inter-Quartile Range|Median
2696117|NCT01272583|Secondary|Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||pmol*minutes/L||Inter-Quartile Range|Median
2696118|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia|Change from initialisation phase to 40 minutes after onset of hypoglycaemia||||pmol/L||Inter-Quartile Range|Median
2696119|NCT01272388|Secondary|6 Minute Walk Distance|How far the subject walked in 6 minutes.|Baseline and 4 weeks|We designed a different pilot trial based on data obtained after this study started - the 2 studies were too overlapping to continue both. We only enrolled one participant (assigned to tadalafil) into the study before stopping the study.|||feet|||Number
2696120|NCT01272388|Primary|Quality of Life as Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)|KCCQ overall summary score is reported. Scale is 0-100 (higher value is better).|Baseline and 4 weeks|We designed a different pilot trial based on data obtained after this study started - the 2 studies were too overlapping to continue both. We stopped this study after only 1 patient (assigned to tadalafil) was enrolled.|||units on a scale|||Number
2696121|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 12 Months"|"Success defined as a response of Very Much Better or Much Better at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|12 months|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the PGI-I.|||percentage of participants|||Number
2696122|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the IIQ-7.|||percentage of participants|||Number
2696123|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the UDI-6.|||percentage of participants|||Number
2696124|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 12 Months|"Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).~The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the cough stress test.|||percentage of participants|||Number
2696125|NCT01272284|Secondary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months|Success defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months.|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the pad weight test.|||percentage of participants|||Number
2696126|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 6 Months"|"Success defined as a response of Very Much Better or Much Better at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|6 months|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the PGI-I.|||percentage of participants|||Number
2696127|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 5 subjects either missed the visit or did not complete the Incontinence Impact Questionnaire.|||percentage of participants|||Number
2696128|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the Urinary Distress Inventory.|||percentage of participants|||Number
2696129|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months|"Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.~Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced."|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 17 subjects either missed the visit or did not complete the 3-Day Voiding Diary.|||percentage of participants|||Number
2696130|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 6 Months|"Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.~The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|6 months|109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test.|||percentage of participants|||Number
2696131|NCT01272284|Primary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months|Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.|6 months (compared to baseline)|Analysis was per protocol. 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the pad weight test.|||percentage of participants|||Number
2696132|NCT01272245|Secondary|Induction Mortality|Death within 8 weeks from the start of treatment.|Up to 1 year||||Participants|||Count of Participants
2696133|NCT01272245|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause|Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.||||Months||Full Range|Median
2696136|NCT01272245|Primary|Percentage of Participants With Complete Remission (CR)|Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia|Up to 4 months||||percentage of participants|||Number
2696137|NCT01272232|Secondary|Incidence of Hypoglycaemic Episodes|Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).|Weeks 0-56|Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.|||Episodes/100 years of patient exposure|||Number
2696138|NCT01272232|Secondary|Change From Week 56 to 68 in Waist Circumference||Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||cm||Standard Deviation|Mean
2696139|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||cm||Standard Deviation|Mean
2696140|NCT01272232|Secondary|Change (%) From Week 56 to 68 in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percent change||Standard Deviation|Mean
2696141|NCT01272232|Secondary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percent change||Standard Deviation|Mean
2696142|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||cm||Standard Deviation|Mean
2696143|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
2696144|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below 7%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
2696145|NCT01272232|Secondary|Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)|Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage point change of HbA1c||Standard Deviation|Mean
2696146|NCT01272232|Primary|Proportion of Subjects Losing More Than 10% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
2696147|NCT01272232|Primary|Proportion of Subjects Losing at Least 5% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
2696148|NCT01272232|Primary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percent change||Standard Deviation|Mean
2696149|NCT01272219|Secondary|Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).|Week 0, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percent change||Standard Deviation|Mean
2696150|NCT01272219|Secondary|Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).|Week 56, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percent change||Standard Deviation|Mean
2707957|NCT01188369|Secondary|N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)|blood sample reflecting stretch of the atrium/ventricle|4 hours after operation until 21 hours after operation|||||||
2696151|NCT01272219|Secondary|Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||percentage of subjects|||Number
2696152|NCT01272219|Secondary|Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||percent change||Standard Deviation|Mean
2696153|NCT01272219|Secondary|Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment|Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||percentage of subjects|||Number
2696154|NCT01272219|Secondary|Pre-diabetes Status After 56 Weeks of Treatment|Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percentage of subjects|||Number
2696155|NCT01272219|Secondary|Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||cm||Standard Deviation|Mean
2696156|NCT01272219|Secondary|Change From Baseline in Waist Circumference (cm)|The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||cm||Standard Deviation|Mean
2696157|NCT01272219|Primary|Proportion of Subjects With Onset of Type 2 Diabetes|Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||Subject|||Number
2696158|NCT01272219|Primary|Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight|Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At 56 weeks|The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percentage of subjects|||Number
2696159|NCT01272219|Primary|Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.|Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percentage of subjects|||Number
2696160|NCT01272219|Primary|Change From Baseline in Fasting Body Weight|The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).|||percent change||Standard Deviation|Mean
2696161|NCT01272193|Secondary|Change in Body Weight|Observed change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
2696162|NCT01272193|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2696163|NCT01272193|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2696164|NCT01272193|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2696165|NCT01272193|Secondary|Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal|Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal|Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||mmol/L||Standard Deviation|Mean
2696166|NCT01272193|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Observed change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2696167|NCT01272180|Primary|Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.|The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.|One month after the second vaccination (Day 91)|"Analysis was done on the Per Protocol Set - desirability, ie, all subjects who :~correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding."|||Desirability index|||Number
2696168|NCT01272180|Secondary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.|Throughout the study ( Day 1 to Day 241)|Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data.|||Participants|||Number
2696169|NCT01272180|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.|Day 1 through day 7 after any vaccination|Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination.|||Participants|||Number
2696170|NCT01272180|Secondary|The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|One month after the second vaccination/prevaccination (Day 91/day 1)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2696171|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.|||Titers||95% Confidence Interval|Geometric Mean
2696172|NCT01272180|Secondary|Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|"The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.~4-fold increase is defined as follows;~for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase."|One month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.|||Percentages of subjects||95% Confidence Interval|Number
2696173|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity|||Percentages of subjects||95% Confidence Interval|Number
2696174|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.|||Titers||95% Confidence Interval|Geometric Mean
2696175|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.|Day 1 and one month after second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.|||Percentages of subjects||95% Confidence Interval|Number
2696176|NCT01272180|Primary|Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.|"Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y.~Seroresponse is defined as:~For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8;~For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer.~Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA)."|One month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations.|||Percentages of subjects||95% Confidence Interval|Number
2696177|NCT01272141|Primary|The Safety and Toxicity of the Combination Therapy of Lapatinib and Everolimus Will be Monitored Using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 3.0. The Incidence of Any Grade 3 or 4 Toxicities Will be Analyzed.||Safety assessments will be performed every four weeks while the patient remains on study.|No data were collected due to early termination.||||||
2696178|NCT01272141|Primary|Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan.||Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.|No data were collected due to early termination.||||||
2696179|NCT01272076|Primary|Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).|In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.|August 2011|Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability.|||mm^2||Standard Deviation|Mean
2696180|NCT01272011|Secondary|Ventilatory Loading - Phase 3|Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.|Pre- versus Post-treatment|Data were collected from 3 participants. However, clinical observations revealed results of interest from only 1/3 of the participants. Therefore, data from only this 1 individual were analyzed for presentation as a case study. The data from the other 2 participants were not analyzed.|||unitless||Standard Error|Mean
2696181|NCT01272011|Primary|Minute Ventilation - Phase 2|Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.|Pre- versus Post-treatment||||percentage of baseline||Standard Error|Mean
2696182|NCT01271946|Secondary|Time to Ambulation|Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per Protocol-Diagnostic Cohort.|||Hours||Standard Deviation|Mean
2696183|NCT01271946|Secondary|Time to Hemostasis|Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.|Hemostasis was evaluated immediately following procedural sheath removal.|Per protocol-Diagnostic Cohort.|||Minutes||Standard Deviation|Mean
2696184|NCT01271946|Primary|Percentage of Participants With Bed Elevation Within 15 Minutes.|Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.|Post procedure|Per protocol.|||Percentage of participants|||Number
2696185|NCT01271946|Primary|Time to Ambulation|Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per protocol.|||Hours||Standard Deviation|Mean
2696186|NCT01271946|Primary|Time to Actual Discharge|The time from sheath removal to actual hospital discharge.|Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.|Per protocol.|||Hours||Standard Deviation|Mean
2696187|NCT01271946|Primary|Time to Discharge Eligibility|The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.|Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.|Per Protocol.|||Hours||Standard Deviation|Mean
2696188|NCT01271946|Primary|Time to Hemostasis|The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.|Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.|Per protocol.|||Minutes||Standard Deviation|Mean
2696189|NCT01271946|Primary|Minor Adverse Events|Observation of any minor access site-related complications.|Procedure through 30 day follow-up.||||Percentage of participants|||Number
2696190|NCT01271946|Primary|Device Success|Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.|Procedure|Intent to treat.|||Percentage of participants|||Number
2696191|NCT01271946|Primary|Major Adverse Events Reported as Percentage of Participants With Adverse Events.|Observation of any major access site-related complication (percentage of participants).|Procedure through 30 day follow-up.||||Percentage of participants|||Number
2696192|NCT01271946|Primary|Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.||Procedure through 30 days follow-up.|||||||
2696193|NCT01271933|Other Pre-specified|Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)|C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm.|Week 1 to Week 7 and Week 11 to Week 20|The population in the single and double blind phase consisted of all paticipants who received at least 1 dose of study medication and who received at least 1 dose of study medication.|||Participants|||Number
2696194|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.|Baseline, Double blind end point visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Percent of daytime||95% Confidence Interval|Least Squares Mean
2696195|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)|"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day."|Baseline, Double blind end point visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Counts of total daytime activity||95% Confidence Interval|Least Squares Mean
2696196|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.|Baseline, Double blind end point visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Percentage of immobile bouts||95% Confidence Interval|Least Squares Mean
2696197|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).|Baseline, Double blind end point visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Minutes||95% Confidence Interval|Least Squares Mean
2696198|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.|Baseline, Double blind end point visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Hours||95% Confidence Interval|Least Squares Mean
2696199|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.|Baseline, Weeks 11, 12, 13, 14 and 15|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Percent of daytime||Standard Deviation|Mean
2696200|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15|"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day."|Baseline, Weeks 11, 12, 13, 14 and 15|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Counts of total daytime activity||Standard Deviation|Mean
2696201|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.|Baseline, Weeks 11, 12, 13, 14 and 15|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Percentage of immobile bouts||Standard Deviation|Mean
2696202|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).|Baseline, Weeks 11, 12, 13, 14 and 15|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Minutes||Standard Deviation|Mean
2696203|NCT01271933|Other Pre-specified|Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.|Baseline, Weeks 11, 12, 13, 14 and 15|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Hours||Standard Deviation|Mean
2696204|NCT01271933|Other Pre-specified|Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.|Baseline, Weeks 3, 4, 5, 6 and 7|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Percent of daytime||Standard Deviation|Mean
2696205|NCT01271933|Other Pre-specified|Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7|"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day."|Baseline, Weeks 3, 4, 5, 6 and 7|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Counts of total daytime activity||Standard Deviation|Mean
2696206|NCT01271933|Other Pre-specified|Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.|Baseline, Weeks 3, 4, 5, 6 and 7|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Percentage of immobile bouts||Standard Deviation|Mean
2696258|NCT01271868|Secondary|Area Under the Curve (0-inf)|"Factor IX levels were assessed at the following time points:~Pre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours"|Pre-infusion to 72 hours following infusion|9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.|||IU*hr/dL||Standard Deviation|Mean
2696207|NCT01271933|Other Pre-specified|Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).|Baseline, Weeks 3, 4, 5, 6 and 7|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Minutes||Standard Deviation|Mean
2696208|NCT01271933|Other Pre-specified|Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7|Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.|Baseline, Weeks 3, 4, 5, 6 and 7|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Hours||Standard Deviation|Mean
2696209|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19|WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696210|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6|WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696211|NCT01271933|Secondary|Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19|The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.|Week 19|"FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed= participants evaluable for specified categories."|||Participants|||Number
2696212|NCT01271933|Secondary|Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6|The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.|Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Participants|||Number
2696213|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in MFI Score at Week 19|The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696214|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6|The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696215|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in FIQ Score at Week 19|The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696216|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6|The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696259|NCT01271868|Primary|Number of Infusions Required for Bleed Control||Treatment Study: at least 50 ED (approximately 6 months); actual mean subject duration: 39.7 ± 12.4 months||||Number of Infusions|Number of Infusions||Count of Units
2696217|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in HADS Score at Week 19|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696218|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696219|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696220|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696221|NCT01271933|Secondary|Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Participants|||Number
2696222|NCT01271933|Secondary|Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Number
2696223|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep|The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||hours||95% Confidence Interval|Least Squares Mean
2696224|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II|The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696241|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit|The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).|Baseline, Double blind endpoint visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696225|NCT01271933|Secondary|Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep|The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||hours||Standard Deviation|Mean
2696226|NCT01271933|Secondary|Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II|The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696227|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)|Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).|Baseline, Week 19|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696228|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)|Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).|Baseline, Week 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2696229|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent).|Baseline, Double blind endpoint visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696230|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Double blind endpoint visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Hours||95% Confidence Interval|Least Squares Mean
2696231|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Double blind endpoint visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Number of times the participant awakened||95% Confidence Interval|Least Squares Mean
2696232|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Double blind endpoint visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Minutes||95% Confidence Interval|Least Squares Mean
2707958|NCT01188369|Secondary|Troponin T (ug/l)|Blood sample expressing damage to the myocytes|21 hours after operation until 96 hours after operation|||||||
2696233|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.|Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||Standard Deviation|Mean
2696234|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.|Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Hours||Standard Deviation|Mean
2696235|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Number of times the participant awakened||Standard Deviation|Mean
2696236|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Minutes||Standard Deviation|Mean
2696237|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.|Baseline, Weeks 1, 2, 3, 4, 5, 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2696238|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Weeks 1, 2, 3, 4, 5, 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Hours||Standard Deviation|Mean
2696239|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Weeks 1, 2, 3, 4, 5, 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants who awakened after sleep.|||Number of times the participant awakened||Standard Deviation|Mean
2696240|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6|The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.|Baseline, Weeks 1, 2, 3, 4, 5, 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Minutes||Standard Deviation|Mean
2696242|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).|Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||Standard Deviation|Mean
2696243|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6|The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).|Baseline, Weeks 1, 2, 3, 4, 5, 6|SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696244|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).|Baseline, Double blind endpoint visit (Week 19)|FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2696245|NCT01271933|Secondary|Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).|Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20|Full analysis set (FAS) consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.|||Units on a scale||Standard Deviation|Mean
2696246|NCT01271933|Secondary|Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Weeks 1, 2, 3, 4, 5, 6|Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2696247|NCT01271933|Primary|Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event|Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.|Randomization to Week 19|FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.|||Participants|||Count of Participants
2696248|NCT01271933|Primary|Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)|The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).|Randomization to Week 19|Full analysis set (FAS) included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.|||Days||95% Confidence Interval|Median
2696249|NCT01271907|Secondary|Investigate Low-dose Systemic Aldesleukin to Cell Efficacy|Low-dose systemic aldesleukin will be evaluated to determine cell activity in metastatic melanoma.|7 months|Zero participants were analyzed for this outcome measure. Greater than 10 participants were needed to evaluate this outcome measure. These were not explored in the small number of patients studied.||||||
2696250|NCT01271907|Primary|Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.|||Participants|||Count of Participants
2696251|NCT01271907|Primary|Clinical Response|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.|||Participants|||Count of Participants
2696252|NCT01271868|Secondary|Annualized Bleed Rate|Measure was assessed during the Treatment Study|Treatment Study: at least 50 ED (approximately 6 months); actual mean subject duration: 41.7+/- 11.7 Months||||bleeds/year||Full Range|Median
2696253|NCT01271868|Secondary|Volume of Distribution (Steady State)|"Factor IX levels were assessed at the following time points:~Pre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours"|Pre-infusion to 72 hours following infusion|9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.|||mL/kg||Standard Deviation|Mean
2696254|NCT01271868|Secondary|Clearance|"Factor IX levels were assessed at the following time points:~Pre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours"|Pre-infusion to 72 hours following infusion|9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.|||mL/(kg*hr)||Standard Deviation|Mean
2696255|NCT01271868|Secondary|Incremental Recovery|"Factor IX levels were assessed at the following time points:~Pre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours"|Pre-infusion to 72 hours following infusion|9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.|||IU/dL per IU/kg||Standard Deviation|Mean
2696256|NCT01271868|Secondary|Concentration (Max)|"Factor IX levels were assessed at the following time points:~Pre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours"|Pre-infusion to 72 hours following infusion|9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.|||IU/dL||Standard Deviation|Mean
2696257|NCT01271868|Secondary|Terminal Half-life|"Factor IX levels were assessed at the following time points:~Pre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours"|Pre-infusion to 72 hours following infusion|9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.|||hours||Standard Deviation|Mean
2703886|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
2696260|NCT01271855|Secondary|Patient Satisfaction|Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).|Discharge|The pain satisfaction at discharge score is unknown for eight participants in the Belladonna and opioid suppository group, and the pain satisfaction at discharge score is unknown for six participants in the Glycerin suppository group.|||units on a scale||Inter-Quartile Range|Median
2696261|NCT01271855|Secondary|Number of Patients Taking Additional Pain Medications|Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.|Twenty-four hours||||Participants|||Count of Participants
2696262|NCT01271855|Primary|Pain Level Twenty Four Hours After Delivery|The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).|Twenty-four hours|The 24-hour visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the 24-hour visual analogue pain score for one participant in the Glycerin suppository group is unknown|||units on a scale||Inter-Quartile Range|Median
2696263|NCT01271803|Secondary|Pharmacodynamics: Number of Participants With Mitogen-Activated Protein Kinase (MAPK) Inhibition, as Assessed by Immunohistochemistry (IHC)|Changes in effector molecules of the MAPK pathway that are directly or indirectly affected by BRAF and MEK inhibition (including but not limited to ERK and phosphorylated ERK and MEK) by IHC using biopsies at baseline, between Days 10−14 of Cycle 1, and at disease progression. IHC is a staining process performed on fresh/frozen tumor tissue samples.|At baseline; Cycle 1: Day 14; at disease progression (Up to 32 months)|Number of participants analyzed=number of participants available for analysis of this outcome measure.|||participants|||Number
2696264|NCT01271803|Secondary|Average Percent Change From Baseline in Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) at Cycle 1 and Cycle 2|The pharmacodynamic effect of cobimetinib in combination with vemurafenib was assessed by measuring changes in FDG uptake as characterized by the lean body mass corrected (LBM) maximum standardized uptake value (SUV max) measurement using FDG-PET. Post-baseline timepoint Cycle 1 was averaged between Days 10 to 14 and Cycle 2 for Days 14+7.|Cycle 1 (Days 10 to 14), Cycle 2 (Days 14+7)|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Percent change in FDG-PET||Standard Deviation|Mean
2696265|NCT01271803|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. OS analyzed using Kaplan-Meier estimate.|Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression or death (up to 82 months)|Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome.|||months||Full Range|Median
2696266|NCT01271803|Secondary|Median Duration of Response (DOR)|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST v 1.1, or death from any cause during the study (that is within 30 days after the last dose of study treatment).|Time from first occurrence of objective response until the time of disease progression or death from any cause (up to 82 months)|Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome. Number of participants analysed who were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
2696267|NCT01271803|Secondary|Percentage of Participants With Disease Progression According to RECIST V 1.1|Progressive disease (PD) according to RECIST V 1.1: at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (nadir), including baseline; in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of 1 or more lesions is also considered as progression.|Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression or death (up to 82 months)|Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome.|||percentage of participants|||Number
2696268|NCT01271803|Secondary|Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1|Tumor response of CR or PR is considered as objective response. CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression (up to 82 months)|Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome.|||percentage of participants||95% Confidence Interval|Number
2696269|NCT01271803|Primary|Tmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2696270|NCT01271803|Primary|Cmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2696271|NCT01271803|Primary|Tmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.|||hours||Full Range|Median
2696272|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in Cohort 1A in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.|||mcg/mL||Standard Deviation|Mean
2696274|NCT01271803|Primary|Tmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.|||hours||Full Range|Median
2696275|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 of Cohorts 1C and 2A in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.|||mcg/mL||Standard Deviation|Mean
2696276|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Days -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2696277|NCT01271803|Primary|Clearance (CL) of Cobimetinib on Day 14 (Steady State), Cycle 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2696278|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 14, Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2696279|NCT01271803|Primary|Tmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2696280|NCT01271803|Primary|Cmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2696281|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 1, Cycle 1 of Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Standard Deviation|Mean
2696282|NCT01271803|Primary|Area Under Concentration Versus Time Curve (AUC) Over a Period of 24 Hours (AUC0-24) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2696283|NCT01271803|Primary|Time Taken to Reach Maximum Plasma Concentration (Tmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2696284|NCT01271803|Primary|Cmax of Cobimetinib on Day 1, Cycle 1 in Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Mean
2696285|NCT01271803|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hours [hr]) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population included all participants who received study treatment and had at least one vemurafenib and cobimetinib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2696286|NCT01271803|Primary|Maximum Tolerated Doses (MTD) of Vemurafenib and Cobimetinib When Administered in Combination in DES|The highest dose level(s) at which fewer than one-third of participants experienced a DLT was declared the MTD. DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade ≤1 within 7 days, b) Grade 3 rash/photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cuSCC that was subsequently resected, d) Grade ≥3 fatigue/hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum CPK levels, which is asymptomatic, deemed to be clinically insignificant and returns to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (ANC <500/ μL), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mg|||Number
2696287|NCT01271803|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During DES in Combination Cohorts|DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum creatine phosphokinase (CPK) levels, which is asymptomatic, deemed by the investigator to be clinically insignificant and that returned to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (absolute neutrophil count [ANC] less than <500/microliter [μL]), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population (SEP) included all participants who received at least one dose of study drug. SEP participants who received combination study treatment (cobimetinib + Vemurafenib) were included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
2696350|NCT01270958|Primary|Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion|AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||U/L||Standard Deviation|Mean
2696288|NCT01271725|Secondary|Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values|Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT−INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)|From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Number Analyzed are the patients with no possible clinically significant abnormality at baseline. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel, or of afatinib and vinorelbine.|||Participants|||Number
2696289|NCT01271725|Secondary|Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)|Change from baseline to end of treatment in diastolic blood pressure (DBP).|Baseline and End of treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. The treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel, or of afatinib and vinorelbine.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2696290|NCT01271725|Secondary|Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)|Change from baseline to end of treatment in systolic blood pressure (SBP).|Baseline and End of treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. The treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel, or of afatinib and vinorelbine.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2696291|NCT01271725|Secondary|Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher|Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.|From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. The treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel, or of afatinib and vinorelbine.|||Percentage of participants|||Number
2696292|NCT01271725|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|From the first objective response to the time of progression or death, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel or of afatinib and vinorelbine. It was not planned to compare between the two types of combination therapies hence arm is combined|||Days||95% Confidence Interval|Median
2696293|NCT01271725|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan−Meier curve.|From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel or of afatinib and vinorelbine. It was not planned to compare between the two types of combination therapies hence arm is combined|||Days||95% Confidence Interval|Median
2696294|NCT01271725|Secondary|Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)|Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel or of afatinib and vinorelbine. It was not planned to compare between the two types of combination therapies hence arm is combined|||Percentage of participants||95% Confidence Interval|Number
2696301|NCT01271712|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST [Response Evaluation Criteria in Solid Tumors] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
2696954|NCT01265550|Secondary|Number of Successful Participants With Anxiety and/or Depression.|Association between anxiety and/or depression (GAD-7 and PHQ-9) and the outcome of medical and surgical treatments (success or failure) will be evaluated.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696295|NCT01271725|Secondary|Best Overall Response According to RECIST v1.1 (With Confirmation)|Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel or of afatinib and vinorelbine. It was not planned to compare between the two types of combination therapies hence arm is combined|||Percentage of participants||95% Confidence Interval|Number
2696296|NCT01271725|Primary|Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1|Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.|From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days|The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel or of afatinib and vinorelbine. It was not planned to compare between the two types of combination therapies hence arm is combined|||Percentage of participants||95% Confidence Interval|Number
2696297|NCT01271712|Secondary|Duration of Response (DOR)|Duration of Response was defined as the time from date of first response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).] or Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set with response participants|||Days||95% Confidence Interval|Median
2696298|NCT01271712|Secondary|Disease Control Rate (DCR)|Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)|||Percentage of Participants||95% Confidence Interval|Number
2696299|NCT01271712|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.|Full Analysis Set (FAS)|||Percentage of Participants||95% Confidence Interval|Number
2696300|NCT01271712|Secondary|Tumor Response|Tumor Response of a subject was defined as the best tumor response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).], Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], Stable Disease [SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], or Progressive Disease [PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)|||Percentage of Participants||95% Confidence Interval|Number
2696348|NCT01270958|Primary|Glucose Value at Baseline and After Treatment Completion|Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
2707959|NCT01188369|Secondary|Troponin T (ug/l)|Blood sample expressing damage to the myocytes|4 hours after operation until 21 hours after operation|||||||
2696302|NCT01271712|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.|From randomization of the first subject until date of database cutoff (08 Jun 2015)|Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015|||Percentage of patients with death|||Number
2696303|NCT01271712|Primary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)|Full Analysis Set (FAS) - defined as all randomized participants.|||Days||95% Confidence Interval|Median
2696304|NCT01271686|Primary|Nocturnal Intraocular Pressure (IOP) Change|Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.|4 weeks||||mmHg||Standard Deviation|Mean
2696305|NCT01271543|Secondary|Time to Complete Laryngoscopy and Successful Intubation||Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.||||seconds||Standard Deviation|Mean
2696306|NCT01271543|Primary|Heart Rate and Blood Pressure Double Product|The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.|Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.|double product (DP) of systolic blood pressure multiplied by heart rate|||(beats/minute)*mmHg||Standard Deviation|Mean
2696307|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.|||Number of Subjects|||Number
2696308|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.|||Number of Subjects|||Number
2696309|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.|||Number of Subjects|||Number
2696310|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 28 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|ITT: all randomized subjects.|||Number of Subjects|||Number
2696311|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.|||Number of Subjects|||Number
2696312|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.|||Number of Subjects|||Number
2696313|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.|||Number of Subjects|||Number
2707960|NCT01188369|Secondary|Lactate (mmol/l)|Arterial sampling of blood lactate|4 hours after operation until 21 hours after operation|||||||
2696314|NCT01271452|Primary|Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)|Number of subjects with a treatment response at Day 28 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|Intent-to-treat (ITT): all randomized subjects.|||Number of Subjects|||Number
2696315|NCT01271413|Secondary|Digit Symbol Substitution Test||baseline, 7 weeks|||||||
2696316|NCT01271413|Secondary|Delay Discounting||baseline, 7 weeks|||||||
2696317|NCT01271413|Secondary|Addiction Severity Index||baseline, 7 weeks|||||||
2696318|NCT01271413|Secondary|go/No-go||baseline, 7 weeks|||||||
2696319|NCT01271413|Secondary|Trail-making||baseline, 7 weeks|||||||
2696320|NCT01271413|Secondary|Episodic Memory||baseline, 7 weeks|||||||
2696321|NCT01271413|Primary|Working Memory|Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks|baseline, 7 weeks||||digits recalled||Standard Deviation|Mean
2696322|NCT01271244|Primary|QT Interval Variability|QT variability index (QTvi) is a measure of QT variability normalized to heart rate variability. Increased QTvi has been associated with increased sympathetic activity. QTvi was calculated using Berger's formula as the log ratio of QT variability normalized by the squared mean QT interval divided by heart rate variability normalized by the squared mean heart rate. QTvi is normally expressed as a negative value, and a less negative QTvi may reflect increased QT variability or reduced heart rate variability.|12 weeks|Due to the small number of subjects in the major depression group, results were not analyzed for this group.|||log ratio||Standard Deviation|Mean
2696323|NCT01271244|Primary|High Frequency Heart Rate Variability|Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure.|12 Weeks|Due to the small number of subjects in the major depression group, results were not analyzed for this group.|||ln(msec)||Standard Deviation|Mean
2696324|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
2696325|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
2696326|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
2696327|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
2696328|NCT01271036|Primary|Number of Participants With Physical Irritation Scores|Severity of physical irritation scored by the Investigator on a scale from 0 (no irritation) to 6 (presence of lesions). Since a score of 0 is required at baseline for inclusion in the study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).|One week|Full Analysis Set|||Participants|||Number
2696329|NCT01271010|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs|An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.|Up to approximately 5 years|All enrolled participants.|||percentage of participants|||Number
2696330|NCT01271010|Primary|Percentage of Participants With Phenotypic Remission|Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2696331|NCT01271010|Primary|Overall Survival|Overall survival was defined as the time period from the first day of study treatment to participant death.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2696349|NCT01270958|Primary|Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion|ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||U/L||Standard Deviation|Mean
2696955|NCT01265550|Secondary|Number of Enrolled Participants With Functional Gallbladder Disorder||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional gallbladder disorder|||Participants|||Count of Participants
2696332|NCT01271010|Primary|Event-free Survival|Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2696333|NCT01271010|Primary|Progression-free Survival|Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2696334|NCT01271010|Primary|Duration of Response|Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2696335|NCT01271010|Primary|Percentage of Participants With Partial Remission|Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2696336|NCT01271010|Primary|Percentage of Participants With Stable Disease|Stable disease was defined as not meeting the criteria for partial remission or disease progression|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2696337|NCT01271010|Primary|Percentage of Participants With Disease Progression|Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2696338|NCT01271010|Primary|Percentage of Participants With Complete Remission|Complete remission was defined as the disappearance of all signs of disease.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2696339|NCT01270971|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2696340|NCT01270971|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2696341|NCT01270971|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2696342|NCT01270971|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.|||participants|||Number
2696343|NCT01270958|Primary|Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion|Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.|Baseline and treatment completion (up to Week 6)|ITT Population|||percentage of participants|||Number
2696344|NCT01270958|Primary|Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion|The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.|Baseline and treatment completion (up to Week 6)|ITT Population|||participants|||Number
2696345|NCT01270958|Primary|Albumin Value at Baseline and After Treatment Completion|Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||g/L||Standard Deviation|Mean
2696346|NCT01270958|Primary|Total Protein Value at Baseline and After Treatment Completion|A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||g/L||Standard Deviation|Mean
2696347|NCT01270958|Primary|Urea Nitrogen Value at Baseline and After Treatment Completion|The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
2696351|NCT01270958|Primary|Alkaline Phosphatase Value at Baseline and After Treatment Completion|Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||U/L||Standard Deviation|Mean
2696352|NCT01270958|Primary|Creatinine Value at Baseline and After Treatment Completion|Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).|Baseline and treatment completion (up to Week 6)|ITT Population|||umol/L||Standard Deviation|Mean
2696353|NCT01270958|Primary|Total Bilirubin Value at Baseline and After Treatment Completion|Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||umol/L||Standard Deviation|Mean
2696354|NCT01270958|Primary|Potassium Count at Baseline and After Treatment Completion|Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
2696355|NCT01270958|Primary|Sodium Count at Baseline and After Treatment Completion|Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
2696356|NCT01270958|Primary|Platelet Count at Baseline and After Treatment Completion|Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||Giga/L||Standard Deviation|Mean
2696357|NCT01270958|Primary|White Blood Cell Count at Baseline and After Treatment Completion|White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||Giga/L||Standard Deviation|Mean
2696358|NCT01270958|Primary|Red Blood Cell Count at Baseline and After Treatment Completion|Red blood cells are cells in the blood that are used to transport oxygen throughout the body. Normal range: 3.9-5.8 10^12 cells per liter (Tetra/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||Tetra/L||Standard Deviation|Mean
2696359|NCT01270958|Primary|Hematocrit Values at Baseline and After Treatment Completion|Hematocrit is the proportion of blood volume that is occupied by red blood cells. The hematocrit (Hct) is expressed as liter of red blood cells in liters of blood. Normal range: 0.35-0.50 Liter/Liter.|Baseline and treatment completion (up to Week 6)|ITT Population|||Liter/Liter||Standard Deviation|Mean
2696360|NCT01270958|Primary|Hemoglobin Values at Baseline and After Treatment Completion|Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||g/L||Standard Deviation|Mean
2696361|NCT01270958|Primary|Heart Rate at Screening/Visit 1, Visit 2, and Visit 3|Heart rate is measured as the number of heart beats per unit time.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population|||beats per minute (bpm)||Standard Deviation|Mean
2696362|NCT01270958|Primary|Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population: Some participants were lost to follow-up and may not have been dosed with study drug.|||mmHg||Standard Deviation|Mean
2696363|NCT01270958|Primary|Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug. Some participants were lost to follow-up and may not have been dosed with study drug.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2696364|NCT01270919|Secondary|To Evaluate the Change in Outcomes From the Preoperative Time Point to Postoperative Time Points in Cases Implanted With the BioDuct® Meniscal Repair Device Using the SF-12, VAS Pain, WOMET and IKDC Subjective Knee Evaluation.||Postoperative compared to preoperative|||||||
2696365|NCT01270919|Primary|To Demonstrate Repair of the Meniscus 6 Months Post-implantation of the BioDuct® Meniscal Repair Device, Utilizing MRI. To Evaluate Clinical Success Using Postoperative Qualitative Criteria, as Compared to Preoperative Findings.||2 years|||||||
2696366|NCT01270880|Secondary|Potential Markers for Predicting Drug Response or Efficacy|Potential markers for predicting drug response or efficacy : This is not a measurable outcome, but a possible entity for further study.|At baseline, day 1 of course 3, and end of treatment|No data was collected for this outcome.||||||
2696367|NCT01270880|Secondary|Association of PFS With PSA|Association of PFS with PSA using Cox PH regression model|At 6 months||||Hazard Ratio||95% Confidence Interval|Number
2696368|NCT01270880|Secondary|OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy|Overall Survival (OS) in metastatic Castrate Resistant Prostate Cancer (CRPC) who have received prior docetaxel therapy using Kaplan-Meier method|From first dose to death or the date last known alive||||months||90% Confidence Interval|Median
2696369|NCT01270880|Secondary|Overall Safety and Tolerability of STA-9090|Overall safety and tolerability of STA-9090 by total number of grade 3 adverse events|Day 1, 8, and 15 of each course and at end of treatment||||events of grade 3+ toxicity|||Number
2696370|NCT01270880|Secondary|Percentage Change in PSA|Percentage change in PSA from baseline.|From baseline to 12 weeks||||percentage change from baseline PSA||Full Range|Median
2696371|NCT01270880|Primary|PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy|Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.|At 6 months||||proportion with 6+ months PFS||90% Confidence Interval|Number
2696372|NCT01270867|Secondary|Secondary Endpoint|Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure|24 hours||||participants|||Number
2696373|NCT01270867|Secondary|Secondary Endpoint|All cause mortality at 90 days|procedure through 90 days||||participants|||Number
2696374|NCT01270867|Secondary|Secondary Endpoint|"Good clinical outcomes at 90 days, as assessed by mRS (a good clinical outcome is defined as mRS </= 2)~mRS 0-2 indicates functional independence 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca"|90 days||||participants|||Number
2696375|NCT01270867|Primary|Primary Safety Endpoint|Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).|within 24 hours of procedure||||participants|||Number
2696376|NCT01270867|Primary|Primary Efficacy Endpoint|"Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device.~Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.~Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...~Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|acute/procedural|Intent to treat analysis was performed. The non-inferiority hypothesis was tested with Blackwelder's method, assuming a one-sided alpha=0.025 and a clinically relevant non-inferiority margin of 10%.|||participants|||Number
2696377|NCT01270841|Secondary|Reproductive Safety|Change from baseline in sperm concentration|3 months|Subjects with end of study assessments|||millions/mL||Standard Deviation|Mean
2696378|NCT01270841|Secondary|Change in FSH After 3 Months of Treatment||3 months|ITT population|||mIU/mL||Standard Deviation|Mean
2696379|NCT01270841|Secondary|Change in Luteinizing Hormone Levels|Changes in values from baseline in LH at month 3|3 months|ITT population|||mIU/mL||Standard Deviation|Mean
2696380|NCT01270841|Primary|Change in Total Morning Testosterone|Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim|3 months|Intent to treat subjects with an assessment after baseline|||ng/dL||Standard Deviation|Mean
2696381|NCT01270828|Secondary|Percentage of Participants With Suicidal Behaviour/Ideation|Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.|Baseline, Weeks 6, 11, 15, 19 and 20|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
2696382|NCT01270828|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective severe to those AEs that interfere significantly with participant's usual function."|Baseline to Week 20|"The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.~Both SBAS and FAS were included in this analysis."|||Participants|||Number
2696383|NCT01270828|Secondary|Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)|The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
2696384|NCT01270828|Secondary|Change in the Brief Pain Inventory (BPI-sf)|The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
2696395|NCT01270828|Secondary|Percentage of Participants With 30% Reduction in the Mean Pain Score.|The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
2707429|NCT01191190|Secondary|Safety and Tolerability Measured Via Adverse Events|Please see Adverse Event module for additional details.|2 years|Total number of participants who had at least 1 adverse event|||participants|||Number
2696385|NCT01270828|Secondary|Change in Hospital Anxiety and Depression Scales (HADS)|The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
2696386|NCT01270828|Secondary|Change in Mean Daily Sleep Interference Scores|The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
2696387|NCT01270828|Secondary|Change in the Short Form 36 Health Survey (SF-36)|The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.|||Units on a scale||Standard Error|Least Squares Mean
2696388|NCT01270828|Secondary|Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score|The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
2696389|NCT01270828|Secondary|The MOS-SS-Optimal Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The percentage of participants with optimal sleep is presented here."|Week 6 and Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
2696390|NCT01270828|Secondary|Change in the MOS-SS-Quantity of Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The item Quantity of sleep of MOS-SS is presented here."|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Hours||Standard Error|Least Squares Mean
2696391|NCT01270828|Secondary|Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).|The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.|||Units on a scale||Standard Error|Least Squares Mean
2696392|NCT01270828|Secondary|Change in the Weekly NRS-Pain (1-Week Recall).|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
2696393|NCT01270828|Secondary|Change From Baseline to Endpoint in Weekly Mean Pain Score.|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
2696394|NCT01270828|Secondary|Percentage of Participants With 50% Reduction in the Mean Pain Score.|The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
2696396|NCT01270828|Secondary|Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results|"A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:~At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score~A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR."|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase|||Participants|||Number
2696397|NCT01270828|Primary|Number of Participants With Loss of Therapeutic Response.|Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.|13 Weeks|The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Participants|||Number
2696398|NCT01270802|Secondary|Change in Serum Levels of Vitamin D|Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body|Baseline and 24 weeks||||ng/mL||Standard Deviation|Mean
2696399|NCT01270802|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Change in FMD is a measure of change in endothelial function|Baseline and 24 weeks|In the Switch to tenofovir/emtricitabine plus raltegravir arm, two FMD measurements at 24 weeks were removed from the analysis due to poor quality imaging.|||% change from baseline||Standard Deviation|Mean
2696400|NCT01270711|Primary|Prevalence of Valvular Fibrosis|Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.|||percentage of participants|||Number
2696401|NCT01270711|Primary|Incidence of Valvular Fibrosis|Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during study period.|||percentage of participants|||Number
2696402|NCT01270711|Primary|Total Number of Echocardiography Examinations in Cabergoline Users|The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.|||echocardiography examinations|||Number
2696403|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
2696404|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
2696405|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
2696406|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
2707430|NCT01191190|Secondary|Treatment-Free Survival||2 years||||months||Full Range|Median
2696407|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
2696408|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
2696409|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6|Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 6 (Year 2011)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
2696410|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 5 (Year 2010)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
2696411|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 4 (Year 2009)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
2696412|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 3 (Year 2008)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
2696413|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 2 (Year 2007)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
2696428|NCT01270620|Primary|Trail Making Part B|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
2707431|NCT01191190|Secondary|Progression-free Survival (PFS)||2 years||||months||Full Range|Median
2696414|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 1 (Year 2006)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
2696415|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 6|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
2696416|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 5|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
2696417|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 4|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
2696418|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 3|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
2696419|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 2|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
2696420|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 1|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
2696421|NCT01270659|Secondary|Number of Participants Experiencing Any Adverse Events|Occurrence of any adverse event.|Full 2 hours of the study period||||Participants|||Count of Participants
2696422|NCT01270659|Secondary|Nausea Level|"Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.~Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).~At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132)."|every 5 minutes for the first 60 minutes||||Participants|||Count of Participants
2696423|NCT01270659|Primary|Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)|Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).|60 minutes||||minutes||95% Confidence Interval|Median
2696424|NCT01270620|Secondary|Amount of Intraoperative Fentanyl||From the anesthesia induction until extubation||||micrograms||Inter-Quartile Range|Median
2696425|NCT01270620|Secondary|Duration of Anesthesia||Time from induction to extubation||||minutes||Inter-Quartile Range|Median
2696426|NCT01270620|Secondary|Duration of Surgery||Time from Incision to closure of surgery||||minutes||Inter-Quartile Range|Median
2696427|NCT01270620|Primary|Trail Making Part B|Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
2696429|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
2696430|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
2696431|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
2696432|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
2696433|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
2696434|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
2696435|NCT01270620|Secondary|ProBNP||Change from baseline to post-operative day 2||||ng/L||Inter-Quartile Range|Median
2696436|NCT01270620|Secondary|BNP||Change form baseline to post-operative day 2||||ng/L||Inter-Quartile Range|Median
2696437|NCT01270620|Secondary|Troponin I|Patients who had troponin level > 0.2 ng/mL|2 days||||participants|||Number
2696438|NCT01270620|Secondary|N-terminal proBNP||Change from baseline to day one||||ng/L||Inter-Quartile Range|Median
2696439|NCT01270620|Secondary|B-type Natriuretic Peptide||Change from Baseline to day one||||ng/L||Inter-Quartile Range|Median
2696440|NCT01270620|Secondary|Recovery Room Time||first day||||minutes||Inter-Quartile Range|Median
2696441|NCT01270620|Secondary|Nausea and Vomiting||48 hours||||participants|||Number
2696442|NCT01270620|Secondary|- Time to Following Command After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
2696443|NCT01270620|Secondary|- Time to Tracheal Extubation After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
2696444|NCT01270620|Secondary|- Time to Eye Opening After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
2696445|NCT01270620|Secondary|- Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
2696446|NCT01270620|Primary|Assessment of Delirium|The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).|48 hours||||participants|||Number
2696447|NCT01270581|Primary|Duration of Respiratory Support|Data not collected due to insufficient enrollment for any data analysis.|average of 7 days|||||||
2696448|NCT01270555|Secondary|Beck Depression Inventory (BDI)|minimum score (least severe depression) = 0, maximum score (most severe) = 63|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
2696449|NCT01270555|Secondary|Hamilton Depression Scale (HAM-D)|minimum score (least severe depression) = 0, maximum score (most severe) = 84|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
2696450|NCT01270555|Secondary|Hamilton Anxiety Scale (HAM-A)|minimum score (least severe anxiety) = 0, maximum (most severe) = 56|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
2696451|NCT01270555|Primary|Self-reported Weekly Substance Use|Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.|baseline and six weeks||||Participants|||Number
2696452|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of ADHD Severity|Global Severity (CGI-S) 1=not ill, 7=extremely ill|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
2696453|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity|CGI-S 1=not ill, 7=extremely ill|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
2696454|NCT01270555|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score|Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
2696455|NCT01270542|Secondary|Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.|Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3)|3 months from last surgery||||logMAR|Eyes|Full Range|Median
2696456|NCT01270542|Secondary|Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.||3 months after last surgery.||||Eyes|Eyes||Count of Units
2696457|NCT01270542|Primary|The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR|Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.|3 months after last surgery||||pg/mL|Eyes|Full Range|Median
2696461|NCT01270464|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Week 8, Week 16, Endpoint, and Overall|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the two experimental treatment arms. Blood samples were collected for determination of ADAs before study drug infusion at baseline, visit 4 (week 8), and at visit 6 (week 16: EOT or early withdrawal) from patients in all 3 treatment groups (ie, placebo, 0.3 mg/kg reslizumab, and 3.0 mg/kg reslizumab); however, only the blood samples drawn from patients treated with either 0.3 mg/kg reslizumab or 3.0 mg/kg reslizumab were analyzed. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).~Endpoint =week 16 or early withdrawal."|Day 1 (pre-dose), week 8, 16 and endpoint|Pharmacokinetic analysis set. Anti-Reslizumab antibody status was not analyzed for patients in the Placebo treatment arm.|||participants|||Number
2696462|NCT01270464|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram Findings|Participant counts in each category of shift from baseline to endpoint of ECG finding. Findings summarized as normal or abnormal.|Weeks -4 to -2 (Screening Visit), Week 16|Safety analysis set of participants with both baseline and endpoint values.|||participants|||Number
2696463|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse - high: >100 and increase of >= 30 beats/minute~Sitting pulse - low: <50 and decrease of >=30 beats/minute~Sitting diastolic blood pressure: >100 and increase of >=12 mmHg~Respiration rate: >24 and increase of >=10 breaths/minute~Body temperature: <96.5° Fahrenheit or <35.8° Celsius~The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set|||participants|||Number
2696464|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.~Total bilirubin: >=34.2 μmol/L~White blood cells: <=3.0 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 %~Platelets: >=700 10^9/L~Absolute neutrophil count: <=1.0 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline~The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set|||participants|||Number
2696465|NCT01270464|Secondary|Participants With Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29).|Day 1 (post-dose) to Week 29|Safety analysis set|||participants|||Number
2696466|NCT01270464|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms. The during treatment (weeks 4, 8, 12 and 16) average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.|||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
2696467|NCT01270464|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.|||SABA puffs per day||Standard Error|Least Squares Mean
2696468|NCT01270464|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control. The during treatment (weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2707961|NCT01188369|Secondary|Mixed Venous Oxygenation (Per Cent)|Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery|4 hours after operation until 21 hours after operation|||||||
2696469|NCT01270464|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 16 or at Last Observed Value|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life. The AQLQ score was only assessed once during the study at week 16 or at early withdrawal, i.e. last postbaseline assessment if within 3 to 5 weeks of the last dose of study drug."|Day 1 (baseline, pre-dose), Week 16 or last observed value|Full analysis set of participants with assessments at stated timeframes.|||units on a scale||Standard Error|Least Squares Mean
2696470|NCT01270464|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2696471|NCT01270464|Secondary|Change From Baseline in % Predicted Expiratory Volume In 1 Second (FEV1) at Week 16 and at Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Endpoint =week 16 or early withdrawal.|Day 1 (baseline, pre-dose), Week 16, endpoint|Full analysis set of participants with assessments at stated timeframes.|||percentage of predicted FEV1||Standard Deviation|Mean
2696472|NCT01270464|Secondary|Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC). The during treatment (weeks 4, 8, 12 and 16) average FEF 25%-75% was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.|||liters/second||Standard Error|Least Squares Mean
2696473|NCT01270464|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. The during treatment (weeks 4, 8, 12 and 16) average FVC was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
2696474|NCT01270464|Primary|Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. The during treatment (weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline scores indicate improvement in asthma control."|Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Full analysis set-all patients randomly assigned to treatment and treated with at least 1 dose of study drug. Number of participants analyzed includes those who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
2696475|NCT01270256|Primary|Change in Nasal Peak Inspiratory Flow (NPIF)|NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated|Baseline and 26 days||||liters/min||Standard Error|Median
2696476|NCT01270139|Secondary|Mean Number of Membrane Defects on Membrane of Red Blood Cells|Mean number of membrane defects on membrane of red blood cells calculated with atomic force microscopy (AFM) in random patients. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The analysis was undergone in eligible random evaluable patients. Only one random patient with exposure of gold nanoparticles was selected for a trial-balloon analysis of cytotoxicity. The blood was collected and split blindly into two ex-vivo experiments with AFM microscopy (see description).|||Mean number of membrane defects per cell|Area of blood sample per patient||Number
2696477|NCT01270139|Secondary|TVR (Target Vessel Revascularization)|TVR (target vessel revascularization) reflects per cent of patients with TVR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.|||Participants|||Count of Participants
2707962|NCT01188369|Secondary|Left Ventricular Rotation (Degrees)|TTE: Index of both systolic and diastolic function|96 hour after operation until 6 months after operation|||||||
2696478|NCT01270139|Secondary|TLR (Target Lesion Revascularization)|TLR (target lesion revascularization) reflects per cent of patients with TLR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.|||Participants|||Count of Participants
2696479|NCT01270139|Secondary|Cardiac Death|Cardiac death includes per cent of patients passed away due to any cardiac death. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.|||Participants|||Count of Participants
2696480|NCT01270139|Secondary|MACE|MACE includes per cent of patients with cardiac death. STEMI (ST-elevation myocardial infarction), non-STEMI, and TLR (target lesion revascularization). An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The intention-to-treat analysis was performed at 60 months.|||Percentage of participants with MACE|||Number
2696481|NCT01270139|Secondary|Minimal Lumen Diameter|Minimal lumen diameter (MLD, mm)|at 12-month follow-up|The intention-to-treat analysis|||mm||Standard Deviation|Mean
2696482|NCT01270139|Secondary|Per Cent of Calcium|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
2696483|NCT01270139|Secondary|Per Cent of Necrotic Core|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
2696484|NCT01270139|Secondary|Per Cent of Fibrous Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
2696485|NCT01270139|Secondary|Target Lesion Revascularization|Target lesion revascularization, per cent|at 12-month follow-up|The intention-to-treat analysis|||Percentage of participants|||Number
2696486|NCT01270139|Secondary|Per Cent Atheroma Volume|Per cent atheroma volume (PAV, plaque burden, %). Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
2696487|NCT01270139|Secondary|Coronary Vasomotion - Mean Lumen Diameter After Infusion of Acetylcholine 10-6 M|Coronary vasomotion was assessed with QCA. End-diastolic images of coronary arteries were evaluated at baseline, after intravascular infusion of acetylcholine (through a microcatheter at increasing doses up to 10-8, 10-7, 10-6 M with a washout period of at least five minutes between each dose), and after nitroglycerine application following acetylcholine (100 µg orally). In all patients, measurements were performed in two segments on site of intervention while 960 seconds. The artery diameter was calibrated against the contrast-filled tip of the catheter. Vasoconstriction to acetylcholine was defined as a 3% change of the mean lumen diameter after infusion of the maximal dose of acetylcholine. An investigator blinded to treatment group performed all measurements.|at 12-month follow-up|The intention-to-treat analysis|||mm||Standard Deviation|Mean
2696488|NCT01270139|Secondary|Late Definite Thrombosis|Late definite thrombosis rate|at 12-month follow-up|The intention-to-treat analysis|||Percentage of participants|||Number
2696489|NCT01270139|Secondary|Restenosis Rate|Restenosis (stenosis>50%) rate|at 12-month follow-up|The intention-to-treat analysis|||Percentage of patients|||Number
2696490|NCT01270139|Secondary|Event Free Survival|The Kaplan-Meier analysis of the cardiac event-free survival (failure-free survival). The end point in this study was cardiac event-free survival during follow-up, starting at randomization. Cardiac events included cardiac death, myocardial infarction and unintended revascularization. Cardiac death was defined as sudden death, death after the onset of symptoms suggestive of cardiac ischemia and death due to heart failure. Noncardiac death was defined as death due to all other causes. Myocardial infarction was defined as an increase in cardiac enzymes or new pathologic Q-waves on the ECG, or both. Unintended revascularization was defined as PTCA or CABG performed due to worsening of the patient's clinical condition, rather than the PTCA or CABG assigned by the revascularization team when patient management was determined.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of survived patients|||Number
2696616|NCT01267422|Secondary|Computerized Visual Field(MD: Mean Deviation, the Value Close to 0 Regarded Normal)|MD: mean deviation, the value Close to 0 regarded normal.VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are MD outcome measure of 8 patients.|||dB||Standard Deviation|Mean
2696491|NCT01270139|Secondary|Per Cent of Fibro-fatty Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
2696492|NCT01270139|Primary|MACE (Major Adverse Cardiovascular Events)-Free Survival|MACE (major adverse cardiovascular events)-free survival reflects per cent of survived patients without MACE. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|Some patients were lost to follow-up at 5 years and were not included to the final analysis. The intention-to-treat analysis was performed at 60 months.|||Percentage of survivors without MACE|||Number
2696493|NCT01270139|Primary|Total Atheroma Volume|Total atheroma volume (TAV, plaque-media volume, mm3) at 12 months. Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat-population analysis|||mm3||Standard Deviation|Mean
2696494|NCT01270126|Secondary|Other Visual and EEG Parameters|Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.|Nov 2006 - Dec 2010|||||||
2696495|NCT01270126|Primary|Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors|Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.|Initial diagnostics (baseline), Post diagnostics||||percent change||Standard Deviation|Mean
2696496|NCT01269918|Secondary|Postoperative Shivering|Indicator of whether patients had postoperative shivering.|Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.||||participants|||Number
2696497|NCT01269918|Secondary|Postoperative Vomitting|Indicator of whether patients had postoperative vomiting.|Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.||||participants|||Number
2696498|NCT01269918|Secondary|Postoperative Nausea|Indicator of whether patients had nausea or not|Whether patients had nausea or not, from anesthesia stop time until hospital discharge.||||participants|||Number
2696499|NCT01269918|Secondary|End Case to Post Anesthesia Care Unit (PACU) Discharge|Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.|End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.||||minutes||Inter-Quartile Range|Median
2696500|NCT01269918|Secondary|Drug Stop Time to Fitness to Discharge||Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.||||minutes||Inter-Quartile Range|Median
2696501|NCT01269918|Secondary|Drug Stop Time to Recall|Time between extubation until patients could say their names.|Time between extubation until patients could say their names.||||minutes||Inter-Quartile Range|Median
2696502|NCT01269918|Secondary|Drug Stop Time to Open Eyes|time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery|Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.||||minutes||Inter-Quartile Range|Median
2696503|NCT01269918|Secondary|Nursing Workload Comparison|To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).|90 minutes after extubation||||units on a scale||Inter-Quartile Range|Median
2696504|NCT01269918|Secondary|Aldrete Score|The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.||||units on a scale||Standard Deviation|Mean
2696505|NCT01269918|Secondary|Modified Short Orientation Memory Concentration Test (SOMCT)|The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.||||units on a scale||Standard Deviation|Mean
2696506|NCT01269918|Secondary|Heart Rate|Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.||||beats per minute||Standard Deviation|Mean
2696507|NCT01269918|Primary|Total Opioid Consumption|Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.|Initial 90 minutes of recover after surgery||||mg morphine equivalents||Inter-Quartile Range|Median
2696617|NCT01267422|Secondary|Average RNFL Thickness Througth Optical Coherence Tomography(OCT) Test|Average RNFL thickness of 8 patients througth Optical coherence tomography(OCT) test before and after treatment|Up to 3 years|RNFL thickness of 8 patients except Patient 1 because he once accepted the other eye's treatment|||Micrometer||Standard Deviation|Mean
2696508|NCT01269918|Primary|Postoperative Pain|Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.||||units on a scale||Standard Deviation|Mean
2696509|NCT01269918|Primary|Hemodynamics|Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.||||mmHg||Standard Deviation|Mean
2696510|NCT01269801|Primary|Efficacy|"Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include:~-Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved.~Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7.~-Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement."|Week 4, 8, 12, 24|Analysis is based on the randomization group to account for the order in which the products were administered.|||participantes rated improved and higher|||Number
2696511|NCT01269749|Secondary|Cancer Risk Assessment|Secondary Aims. (i) As a follow-up to the first primary aim, we will calculate potential cancer risk from the radiation exposure data; and (ii) within the analyses for the second primary aim, we will evaluate chromosomal translocation in children treated with 131I vs. not, as related to age and dose of 131I.|4 years|Data was not collected||||||
2696512|NCT01269749|Primary|Dosimetry Studies|Primary Aims. We propose to (1) perform dosimetry to assess whole body radiation exposure following 131II therapy in children treated for GD; and (2) assess the effects of 131I treatment of GD (treated with medication or surgery) on chromosome translocations.|4 years|Data was not collected||||||
2696513|NCT01269736|Secondary|Patient Outcomes|Mortality, in-hospital MI, and not surviving a cardiac arrest were obtained using administrative data and laboratory data (eg, troponin, CK-MB) for all patients. Mortality was defined as death that occurred on one of the participating units. To identify the occurrence of in-hospital MI, laboratory data, timing of procedures, and location of patient at the time of the first blood draw indicating the event were used. Cardiac arrest was defined as an event initiated by an arrhythmia that required immediate intervention and was initiated on a PULSE participating unit. For each qualifying cardiac arrest, it was determined whether the patient survived the event.|Baseline, 15 months, 30 months|The overall number of unique patients reviewed at any timepoint. The numbers presented at each time point reflect the number of people reviewed at that time point for that outcome.|||Participants|||Count of Participants
2696514|NCT01269736|Secondary|Quality of Patient Care Related to ECG Monitoring|Percentage of patients with accurate electrode placement, accurate rhythm interpretation, cardiac arrest, cardiac arrest initiated by arrhythmia, appropriate monitoring, telemetry units only, ST-segment monitoring when indicated, and QTc measurement when indicated|Baseline, 15 months, 30 months|The overall number of unique patients assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point.|||Participants|||Count of Participants
2696515|NCT01269736|Primary|Nurses' Knowledge and Skills Related to ECG Monitoring|Participants took a 20-item online test on essentials of ECG monitoring, and arrhythmia, ischemia, and QT interval monitoring. Scores represent the percentage of correct answers. (Test scores range from 0 to 100 with higher scores representing more correct answers)|Baseline, 15 months, 30 months|The overall number of unique nurses assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point.|||percentage of items correctly answered||Standard Deviation|Mean
2696516|NCT01269710|Secondary|Change in LDL (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
2696517|NCT01269710|Secondary|Change in Triglycerides (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
2696518|NCT01269710|Secondary|Change in Total Cholesterol (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
2696519|NCT01269710|Secondary|Change in Glucose Levels (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
2696618|NCT01267422|Secondary|Neutralizing Antibody Assay|The mean of Neutralizing antibody assay of 8 patients before and after treatment|up to 3 years|Neutralizing antibody assay of 8 patients except Patient 1 because he once accepted the other eye's treatment|||titer||Standard Deviation|Mean
2696520|NCT01269710|Primary|Change in Weight (in Lbs.)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||lbs.||Standard Deviation|Mean
2696521|NCT01269346|Secondary|Duration of Stable Disease (SD)|Defined as the period from treatment start date to the date of PD or death, whichever occurred first. Participants who were alive without having PD as of the data cutoff date were censored as of their last tumor assessment. Calculated for participants who best response was SD.|Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2696522|NCT01269346|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment.|Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2696523|NCT01269346|Secondary|Duration of Response (DOR)|Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.|Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug. Analyzed for responders only (n = 37).|||Months||95% Confidence Interval|Median
2696524|NCT01269346|Secondary|Time to First Response|Time to first response was defined for participants whose best overall response was a CR or PR.|From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug. Analyzed for responders (CR or PR) only.|||Months||95% Confidence Interval|Median
2696525|NCT01269346|Primary|Objective Response Rate|The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.|Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR|FAS included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2696526|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|4 weeks after a positive pregnancy test|In order to handle the problem of small sample size bootstrap techniques are used. Ader et al recommend bootstrap procedures(a) distribution is complicated or unknown, (b) a small sample is available. Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.|||Percentage||95% Confidence Interval|Mean
2696527|NCT01269125|Secondary|Follicular Fluid's TNF-a Concentration.|TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.|June 2004-August 2010||||pg/ml||Standard Deviation|Mean
2696528|NCT01269125|Primary|Fertilization Rate (Percentage of Fertilized Oocytes).|The fertilization rate was estimated for every woman 24 hours after oocyte retrieval|June 2004-August 2010||||percentage||95% Confidence Interval|Mean
2696529|NCT01269125|Primary|Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).|Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with < 10%, < 10-20%, < 20-30% and >30% fragments were estimated as grade 1,2,3 and 4, respectively.|June 2004-August 2010||||Percentage of grade 1 embryos||95% Confidence Interval|Mean
2696530|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|June 2004-August 2010|The study period was seven years. Practical issues such as, no more funds for measuring cytokines, my transportation to different University stopped this study before reaching adequate power. The flow of the participants in our Department was low.|||percentage||95% Confidence Interval|Mean
2696531|NCT01269047|Secondary|Difference in HbA1C Between the Treatment and the Control Groups||6 months||||percentage of HbA1C values||Standard Deviation|Mean
2696532|NCT01269047|Primary|Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus.|We measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus|6 months||||mmol/L||Standard Deviation|Mean
2696619|NCT01267422|Secondary|Intraocular Pressure;||Up to 3 years||||mmHg||Full Range|Mean
2696620|NCT01267422|Primary|Results of CD3/CD4/CD8 Test|The mean percentage of CD3+/CD4+/CD8+ test before and after treatment|up to 6 months||||Percentage of total cells||Full Range|Mean
2696533|NCT01268943|Primary|Dose Related Toxicity|dose related toxicity is defined as follows:1. WBC damage >= grade 3; granular cell decrease >= grade 3; hemoglobin >= grade 2; platelet >= grade 2;SGPT/SGOT elevation >= grade 2; ALP >= grade 2; GGT >= grade 2; Tbil >= grade 2;renal function damage: BUN/Cr elevation >= grade 2;Non-gradular cell decreased fever >= grade 2;nausea/vomiting >= grade 2; fatigue >= grade 3; weight loss >= grade 3;gastritis >= grade 3; dairrea >= grade 3; abdominal pain >= grade 3; pancreatitis >= grade 2; upper gastrointestinal bleeding >= grade 2;other toxic reaction >= grade 3;KPS < 50 during the treatment|up to 9 weeks||||event|||Number
2696534|NCT01268891|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF|||units on a scale||Standard Error|Mean
2696535|NCT01268891|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF|||units on a scale||Standard Error|Mean
2696536|NCT01268891|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 18|FAS; last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
2696537|NCT01268891|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary|"Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.~The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time."|Baseline and Weeks 6, 10, 14, and 18|Full-analysis set (FAS); observed cases (OC)|||hours||Standard Error|Mean
2696538|NCT01268683|Secondary|Clinical and MRI Outcome Data|The proportion of subjects with mRS <=4 expressed as a % (total number of patients with mRS <=4 divided by total number of patients enrolled).|90 days||||percentage of participants|||Number
2696539|NCT01268683|Secondary|Pharmacokinetics/Pharmacodynamics|The number of patients with unanticipated PK or PD responses was assessed. An unanticipated PK or PD response would have been, for instance, a peak concentration inconsistent with prior PK assessments, or an unexpectedly low blood glucose level (< 40 mg/dL)|3 days||||participants|||Number
2696540|NCT01268683|Secondary|Safety and Tolerability|"AE's of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all SAE's will be followed for 90 days.~SAE's and AE's were reviewed, and the number of subjects with unanticipated adverse events, or drug-related SAE's were assessed."|90 days||||participants|||Number
2696541|NCT01268683|Primary|Rate of Recruitment|The number of months it took to enroll the 10 patients|11 months||||months|||Number
2696542|NCT01268644|Secondary|Change in HbA1c From Baseline to Week 20 on Leptin Therapy|Change in Hba1c after 20 weeks on Leptin Therapy compared to Baseline value. With ongoing metreleptin therapy, the concomitant basal insulin dose was actively reduced by 50% after week 12.|Baseline to Week 20 (On leptin)||||% of Hemoglobin||95% Confidence Interval|Mean
2696543|NCT01268644|Secondary|Insulin Dose|Change in Insulin dose after 12 weeks on Leptin Therapy compared to Baseline value|Baseline to 12 weeks|One subject withdrew after 12 weeks.|||units/day||95% Confidence Interval|Mean
2696544|NCT01268644|Secondary|Weight|Change in Body Weight after 12 weeks on Leptin Therapy compared to Baseline value|Baseline to 12 weeks|One subject withdrew after 12 weeks.|||kg||95% Confidence Interval|Mean
2696545|NCT01268644|Primary|HbA1c|Change in Hba1c after 12 weeks on Leptin Therapy compared to Baseline value|Baseline and 12 weeks||||% of hemoglobin||95% Confidence Interval|Mean
2696546|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Vital Sign Parameters|Vital sign assessments were conducted throughout the study and included body temperature, blood pressure (seated), pulse rate and respiratory rate. The TEAEs related to vital signs in participants were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
2696547|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time period) and analyzed. Number of participants with TEAEs related to ECG after the start of study drug administration were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
2696556|NCT01268566|Secondary|Duration of Response|Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. Duration of response was estimated using Kaplan-Meier method and evaluated only for the participants of subgroup with an objective response.||ITT population with an objective response (ie, confirmed CR or PR) were assessed. Duration of response was not estimable as there were no participants with an objective response.||||||
2696965|NCT01265550|Secondary|Number of Enrolled Participants With Functional Dysphagia||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional dysphagia|||Participants|||Count of Participants
2696548|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count with differential); serum chemistry (calcium, chloride, magnesium, potassium, sodium, aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma glutamyl transferase, lactic dehydrogenase, carbon dioxide/bicarbonate, blood urea nitrogen, uric acid, creatinine, total bilirubin, glucose, albumin, total protein, triglycerides, cholesterol, phosphorous); urinalysis (pH, protein, blood, glucose, ketones, bilirubin); and coagulation parameters. Abnormal laboratory finding that required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation, was reported as an AE. Number of participants with TEAEs related to laboratory evaluations were reported.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
2696549|NCT01268566|Secondary|Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study|Eastern Cooperative Oncology Group (ECOG) performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (fully active ie, best) to 5 (dead ie, worst). Following are ECOG grades: 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
2696550|NCT01268566|Secondary|Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are AEs occurring or worsening after the administration of study drug until 90 days after the last dose of study drug or until the participant began another anticancer therapy, which ever came first. A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. The TEAEs and SAEs were summarized using MedDRA version 15.1. Participants were counted only once for each event, regardless of number of events the participant had.|Baseline to last record on study, up to 21 months|Safety population included all participants who received at least 1 dose of MEDI-575.|||Participants|||Number
2696551|NCT01268566|Secondary|Percentage of Participants With Expression of PDGFR Alpha in the Tumor Samples|MEDI-575 (study drug) blocks platelet-derived growth factor (PDGF) binding to PDGF receptor (PDGFR) alpha and inhibits signaling. The tissue samples which were collected prior to the study entry (archived tumor samples) were evaluated by immunohistochemistry staining for expression of PDGFR alpha signaling protein that are targets of MEDI-575. Expression of PDGFR alpha in tumor cells and tumor-associated stromal cells were evaluated for intensity and distribution of staining. The percentage of participants with positive PDGFR alpha staining in the tumor cells and tumor-associated stromal cells were reported.|Screening (Day-28 to Day -1)|ITT population with archived tumor samples were assessed.|||Percentage of participants|||Number
2696552|NCT01268566|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, Overall survival was censored on the last date when participants were known to be alive. The Overall survival was estimated using the Kaplan-Meier method.|Study entry to death, up to 16 months|ITT population. N= number of participants analyzed for this outcome measure|||Months||90% Confidence Interval|Median
2696553|NCT01268566|Secondary|Progression-free Survival|PFS was measured from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Time to PFS was estimated using Kaplan-Meier method.|9 months|ITT population. N= number of participants analyzed for this outcome measure|||Months||90% Confidence Interval|Median
2696554|NCT01268566|Secondary|Progression-free Survival Rate at 3 Months and 9 Months|PFS rate at 3 and 9 months is defined as proportion of participants who neither progressed nor died due to any cause, whichever occurred first after first dose at 3 months and 9 months, respectively. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. Proportion of participants with PFS at 3 and 9 months were estimated using Kaplan-Meier method.|3 months and 9 months|ITT population|||Percentage of participants||90% Confidence Interval|Number
2696555|NCT01268566|Secondary|Time to Progression|Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression was defined by at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. TTP was estimated using Kaplan-Meier method.|Study entry until the first documented disease progression, up to 16 months|ITT population. N= number of participants analyzed for this outcome measure|||Months||90% Confidence Interval|Median
2708141|NCT01187381|Secondary|Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer||Baseline up to 5 years|All enrolled participants|||percentage of participants|||Number
2696557|NCT01268566|Secondary|Time to Response|Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was estimated using Kaplan-Meier method.||ITT population with an objective response (ie, confirmed CR or PR) were assessed. TTR was not estimable as there were no participants with an objective response.||||||
2696558|NCT01268566|Secondary|Percentage of Participants With Objective Response|Objective response rate (ORR) is defined as the proportion of participants with confirmed CR or confirmed PR using RANO criteria. Confirmed CR and PR are those that persist on repeat imaging study for at least 4 weeks after the initial documentation of the response. CR is defined as complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, patient is off corticosteroids and stable or improved clinically. PR is defined as 50% decrease compared with baseline in the measurement of all measurable enhancing lesions sustained for at least 4 weeks, no progression of nonmeasurable disease, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, no increase in the corticosteroid dose and stable or improved clinically.|Study entry through the end of the study, up to 21 months|ITT population|||Percentage of participants||90% Confidence Interval|Number
2696559|NCT01268566|Secondary|Percentage of Participants With Best Overall Response|Best overall response rate is calculated based upon the disease assessments recorded during the study visits using RANO criteria. Best overall response includes complete response (CR), CR with confirmation, partial response (PR), PR with confirmation, stable disease and progressive disease. Confirmed responses are those that persist on repeat imaging studies at least 4 weeks after the initial documentation of response.|Study entry through the end of the study, up to 21 months|ITT population|||Percentage of participants|||Number
2696560|NCT01268566|Primary|Progression-free Survival Rate at 6 Months|Progression-free survival (PFS) rate at 6 months is defined as the proportion of participants who neither progressed nor died before 6 months after the first dose. Progression was determined using Updated Response Assessment Criteria of High Grade Gliomas: Response Assessment in Neuro-Oncology Working Group (RANO criteria). Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/fluid attenuated inversion recovery (FLAIR) nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS-6 was estimated using Kaplan-Meier method.|6 months|Intent-to treat (ITT) population: All participants who entered into the study (ie, participants for whom investigator notified the interactive web response system [IWRS] that the participant met eligibility criteria and the IWRS assigned unblinded study drug to the participant).|||Percentage of participants||90% Confidence Interval|Number
2696561|NCT01268553|Secondary|N-terminal Pro BNP Level|N-terminal pro BNP level|12 weeks||||pg/mL||Standard Deviation|Mean
2696562|NCT01268553|Secondary|CAMPHOR: Cambridge Pulmonary Hypertension Outcome Review; Construct = Quality of Life|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a disease specific patient-reported outcome measure which assesses quality of life of patients with pulmonary hypertension (PH). QoL scores (total) range from 0-25, with higher scores indicating worse quality of life|12 q=weeks||||units on a scale||Standard Deviation|Mean
2696563|NCT01268553|Secondary|VE/VCO|Ventilatory efficiency measured with cardiopulmonary exercise testing|12 weeks||||ratio||Standard Deviation|Mean
2696564|NCT01268553|Secondary|Change in 6-minute Walk Distance|Change in 6-minute walk distance from baseline to 12 weeks.|12 weeks|Mean change in 6-minute walk distance|||meters||Standard Deviation|Mean
2696565|NCT01268553|Secondary|Number of Participants Without Clinical Worsening|"Clinical worsening is defined as any of the following:~All-cause mortality~Nonelective hospital stay for PAH (with predefined criteria, usually for initiation of intravenous prostanoids, lung transplantation, or septostomy)~Disease progression defined as a reduction from baseline in the 6MW test by 15%, confirmed by 2 studies done within 2 weeks plus worsening functional class"|12 weeks|Patients weaned off of their parenteral prostanoids without Clinical Worsening|||Participants|||Count of Participants
2696566|NCT01268553|Primary|Number of Participants Without Adverse Events|The number of adverse events will be recorded at transition, 4 weeks, and 12 weeks.|12 Weeks|Number of patients weaned off of their parenteral prostanoids without adverse events|||Participants|||Count of Participants
2696567|NCT01268514|Secondary|Number of Participants With Post-op Complications|Subject incidence of post-operative complications, specifically: wound infection, seroma, hematoma, wound dehiscence, and fistula. Unscheduled surgery is any surgery that is performed outside of the primary study procedure.|6, 12, 24 and 36 months post-surgery|The overall number analyzed is the total number of patients for the study. The number analyzed in each row relates to the number of patients at each visit who had one of these adverse events.|||Participants|||Count of Participants
2696568|NCT01268514|Secondary|Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome|"Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.~Question: How satisfied are you with the outcome of the operation?"|6, 12, 24 and 36 months post-surgery|This was the number of patients included in this study assessment.|||Participants|||Count of Participants
2696569|NCT01268514|Secondary|Patient Satisfaction Questionnaire - Right Choice to Have Surgery|"Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.~Question: Was it the right choice to have the surgery?"|6, 12, 24 and 36 months post-surgery|This is the number of patients whom were included in this study assessment.|||Participants|||Count of Participants
2696570|NCT01268514|Secondary|QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.|"Quality of Life by Carolina's Comfort Scale at 6 months, 12 months, 24 months, and 36 months. The areas of assessment were: Sensation of Mesh, Pain, and Movement Limitations at each of the follow-up time points. Unscheduled surgery is any surgery that is performed outside of the primary study procedure.~The scale measurements: 0 = no symptoms; 1 = mild but not bothersome symptoms; 2 = mild and bothersome symptoms; 3 = moderate and/or daily symptoms,;4 = severe symptoms; 5 = disabling symptoms"|6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.|We excluded patients who were not included in this assessment at the 6 - 36 month post-surgery follow-up time points.|||Scores on a scale||Standard Deviation|Mean
2696571|NCT01268514|Secondary|Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence|Characterize short-term and mid-term outcomes within 24 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.|24 months post-surgery|Proportion of subjects who underwent reoperation for hernia or hernia recurrence at 24 month post-surgery follow-up.|||Participants|||Count of Participants
2696572|NCT01268514|Primary|Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery|Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.|36 months post-surgery|This was the number of respondents at the 36-month follow up visit for this assessment.|||Participants|||Count of Participants
2696573|NCT01268501|Primary|Overall Convenience With Contact Lenses|"Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied."|3 weeks of wear|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.|||Percentage of participants||95% Confidence Interval|Number
2696574|NCT01268488|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|158 BG results-78 subjects tested 2 strip lots;2 subjects tested 1 strip lot. 7 subjects-Low BG results disallowed forearm testing per protocol. 1 subject-Missing data. Remainder same as 'palm' analysis population description.|||Number of BG Test Results|Participants||Number
2696575|NCT01268488|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|97 participants analyzed: one subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated. For palm and forearm testing tasks, 2 additional subjects (with nonevaluable BG data) were not included. Only 95 participants were rated for those particular tasks.|||participants|||Number
2696576|NCT01268488|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|161 BG results-80 subjects tested 2 strip lots;1 subject had 1 reading. Withdrawn by PI- 3 subject Adverse Events before performance testing;1 subject did not meet inclusion/exclusion. 6 subjects- Data not evaluable:exceeded time between meter testing and reference method. 7 subjects-Low bg results disallowed palm testing per protocol.|||Number of BG Test Results|Participants||Number
2696577|NCT01268488|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|178 BG results possible-88 subjects tested 2 strip lots(88x2)/2 subjects had 1 reading(2x1). Withdrawn by Principal Investigator(PI)-3 subjects experienced Adverse Events before performance testing / one subject did not meet inclusion/exclusion. Data from 4 subjects were not evaluable since exceeded time between meter testing and reference method.|||Number of BG Test Results|Participants||Number
2696578|NCT01268306|Primary|Number of Participants Wiith Corneal Staining|The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.|2-4 hours after contact lens insertion|Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination|||participants|||Number
2696579|NCT01268293|Primary|Number of Participants With Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).|Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).|The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Number
2696580|NCT01268293|Primary|Number of Participants With Dose Limiting Toxicity (DLT)||Up to 4 weeks|Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.|||Participants|||Number
2709604|NCT01176058|Secondary|Number of Participants Who Died||Baseline to Day 52|Safety population: All participants who have received at least one dose of study medication.|||participants|||Number
2696581|NCT01268267|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.|||Number of BG test results|Participants||Number
2696582|NCT01268267|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.|||participants|||Number
2696583|NCT01268267|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.|||Number of BG test results|Participants||Number
2696584|NCT01268267|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.|||Number of BG test results|Participants||Number
2696585|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 12||||units on a scale||Standard Deviation|Mean
2696586|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 10||||units on a scale||Standard Deviation|Mean
2696587|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 8||||units on a scale||Standard Deviation|Mean
2696588|NCT01268189|Secondary|Pain Perceived by Patient|Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.|Post-Operative Day 4||||units on a scale||Standard Deviation|Mean
2696589|NCT01268189|Primary|Healing Time for Donor Site Wounds|Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.|number of days to healing||||days||Standard Deviation|Mean
2696590|NCT01268150|Other Pre-specified|To Assess the Incidence of Adverse Events (AEs) of Eribulin Mesylate|Treatment-emergent adverse events (TEAEs) were defined as AEs that emerged during treatment, having been absent at pretreatment, and occurring within 30 days of the last dose of study treatment, or if they were present prior to the first dose administration and increased in severity during the study. For each AE a participant with two or more TEAEs in that category were counted only once. TEAEs were considered related if the relationship of the event to study drug was possibly or probably related. Serious adverse events (SAEs) were defined as any untoward medical experience that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. Safety information will be summarized with adverse events. AEs were graded on a five-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline until End of Treatment (within 21 days of last dose), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Safety Analysis Set population included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment.|||Percentage of participants|||Number
2696591|NCT01268150|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.|Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.|||Months||95% Confidence Interval|Median
2696592|NCT01268150|Secondary|Duration of Response|Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.|First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.|||Months||95% Confidence Interval|Median
2696593|NCT01268150|Secondary|Time to First Response (CR or PR)|Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.|Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.|||Months||95% Confidence Interval|Median
2696594|NCT01268150|Primary|Objective Response Rate (ORR)|The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR|Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.|||Percentage of participants|||Number
2696595|NCT01268111|Primary|M Value (Insulin Stimulated Glucose Uptake)|Insulin stimulated glucose uptake will be measured by glucose clamp studies|Baseline and at 8 weeks||||mg/kg.min||Standard Deviation|Mean
2696596|NCT01268098|Secondary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2696597|NCT01268098|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.|The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2696598|NCT01268046|Primary|Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC)|Change in extracted beta coefficients of the blood oxygen level dependent (BOLD) signal response to a cognitive task (N-back) in the DLPFC (x,y,z coordinates = -34 44 16) from baseline to 1 month as a function of aging and estrogen (young vs older and estrogen vs placebo). A positive change indicates an increase in oxygen utilization (inferring increased neuronal functioning) between baseline and treatment during the cognitive task, while a negative change indicates a decrease in oxygen utilization between baseline and treatment during the cognitive task.|baseline to 1 month|all young and older postmenopausal women who completed one month of placebo or estrogen and in whom structural and functional MRI data were of significant quality for analysis.|||linear beta extractions||Standard Error|Mean
2696599|NCT01267994|Secondary|Number of Serious Adverse Events Reported|To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra|84 days|Any subject enrolled in this study who received at least 1 injection dose of anakinra|||reported SAEs|||Number
2696600|NCT01267994|Primary|To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease|The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.|180 days||||responders|||Number
2696601|NCT01267955|Secondary|Expression Pattern of Hedgehog Signaling Molecules by Using Quantitative Reverse Transcription-polymerase Chain Reaction and Immunohistochemistry|The 6-months clinical benefit rate will be correlated with the expression score of hedgehog signaling molecules in order to identify predictive factors of clinical benefit from vismodegib.|Baseline|||||||
2696602|NCT01267955|Secondary|Mutational Status of Patched 1 and Smoothened|The 6-months clinical benefit rate will be correlated with the mutational status of patched and smoothened in order to identify predictive factors of clinical benefit from vismodegib.|Baseline|||||||
2696660|NCT01267136|Secondary|Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.|Parent-reported side effects entered in 10-day diary.|Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.||||participants|||Number
2696603|NCT01267955|Secondary|Duration of Response|Will be described in responding subjects using descriptive statistics (median, extreme values, etc.).|From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|||||||
2696604|NCT01267955|Secondary|Overall Survival Per Response Evaluation Criteria in Solid Tumors Criteria 2009|Overall survival will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|Time from start of treatment to the time of death, assessed up to 3 years|||||||
2696605|NCT01267955|Secondary|Progression-free Survival|Will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years|||||||
2696606|NCT01267955|Primary|Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1|CBR was defined as the percentage of participants with complete or partial responses (CR, PR) or stable disease (SD) per RECIST 1.1. CR was defined as disappearance of all non-nodal target lesions. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analysis of response was performed based on radiological centralized review. A 2-stage optimal Simon's design with 37 participants (first stage: 17 participants) was used. If 3 or less non-progressions (CR + PR + SD) at 6 months were observed during stage 1 (out of 17 participants), the trial would stopped early. Otherwise, 20 additional patients would be accrued for stage 2. If 11 or more non-progressions (out of 37 participants) were observed at the end of recruitment, further investigation of this therapy would be warranted.|At 6 months after inclusion|Eligible participants with at least one complete or two incomplete cycles of treatment and for whom at least one disease measurement has been recorded not less than 8 weeks after treatment onset.|||percentage of participants||95% Confidence Interval|Number
2696607|NCT01267929|Primary|The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.|The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates < 10% of activity,2=partially completes 10% to < 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.|Base line, two months and six months|A total of 30 children with cerebral palsy was followed and completed the study.|||Scores on a scale||Standard Deviation|Mean
2696608|NCT01267864|Secondary|Adverse Event|% who report any adverse event after administration of investigational medication|24 hours|Any adverse event reported at any assessment throughout the study period.|||Participants|||Count of Participants
2696609|NCT01267864|Secondary|Satisfaction With Medication|% who answer the following question affirmatively at 24 hours: Do you want to receive the same medication the next time you present to an ER with an acute migraine|24 hours|Study participants were telephoned 24 hours after medication administration. 3 patients in the metoclopramide arm, 4 in the ketorolac arm, and 3 in the valproate arm were lost to follow-up and did not provide these data. Additionally, 1 patient in the ketorolac arm did not provide an answer to this question|||Participants|||Count of Participants
2696610|NCT01267864|Secondary|Participants Who Achieve Sustained Headache Freedom for 24 Hours|Number of participants achieving a pain free state within two hours and maintaining the pain free state for 24 hours after receipt of medication|2- 24 hours after receipt of medication|Please note that 1 patient in the metoclopramide arm and 1 patient in the ketorolac arm were lost-to-follow-up and did not provide data for this outcome|||Participants|||Count of Participants
2696611|NCT01267864|Primary|Headache Pain Level on a 0-10 Verbal Scale|Verbal Numerical Rating scale for pain. Absolute change from baseline. This is a 0-10 scale on which 0= no pain and 10= the worst pain imaginable.|60 minutes after receipt of medication||||units on a scale||95% Confidence Interval|Mean
2696612|NCT01267825|Secondary|Adverse Events|Any adverse events since randomization. %s will be compared between groups|1 week after discharge from emergency department|Study terminated due to low enrollment. No patient data was collected.||||||
2696613|NCT01267825|Secondary|Functional Disability Assessed Using Roland-Morris Scale|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, increasing functional disability."|1 month|Study terminated due to low enrollment. No patient data was collected.||||||
2696614|NCT01267825|Primary|Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians."|Baseline and one week after emergency department discharge|Study terminated due to low enrollment. No patient data was collected.||||||
2696615|NCT01267422|Secondary|Computerized Visual Field(VFI: Visual Field Index ,the Value Close to 100% Regarded Normal)|VFI: visual field index ,the value Close to 100% regarded normal. VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are VFI outcome measure of 8 patients.|||Percentage of normal||Standard Deviation|Mean
2696956|NCT01265550|Secondary|Number of Enrolled Participants With Unspecified Functional Bowel Disorder||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for unspecified functional bowel disorder|||Participants|||Count of Participants
2696621|NCT01267422|Primary|The Best Corrected Visual Acuity(BCVA)||Up to 3 years|The data are expressed as mean±standard error. Comparisons before and after treatment of the BCVA were analyzed using the paired t-test.A probability (P) value of less than 0.05 was considered statistically significant.Lower logMAR represents a better outcome.|||logMAR|logMAR|Standard Error|Mean
2696622|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|Monday of week 4||||number of perseverative errors||Standard Deviation|Mean
2696623|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|Thursday of week 1||||number of perseverative errors||Standard Deviation|Mean
2696624|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|baseline||||number of perseverative errors||Standard Deviation|Mean
2696625|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|Monday of week 4||||a-prime||Standard Deviation|Mean
2696626|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|Thursday of week 1||||a-prime||Standard Deviation|Mean
2696627|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|baseline||||a-prime||Standard Deviation|Mean
2696628|NCT01267292|Secondary|Diastolic Blood Pressure|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Diastolic blood pressure is the blood pressure when the heart muscle is between beats."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||mmHg||Standard Deviation|Mean
2711595|NCT01161862|Secondary|Percentage of Time Spent With Blood Glucose 70-180 mg/dl||48 hours|Overall number of participants=24 (12 in each arm)|||percentage of total time||Standard Deviation|Mean
2696629|NCT01267292|Secondary|Systolic Blood Pressure|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||mmHg||Standard Deviation|Mean
2696630|NCT01267292|Secondary|Heart Rate|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Heart rate is the measure of heart beats per minute."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||beats per minute||Standard Deviation|Mean
2696631|NCT01267292|Secondary|"Subjective Effects as Assessed by the Elated Subscale of the Visual Analogue Scale (VAS)"|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The VAS presents 100-mm horizontal lines labeled with an adjective: stimulated, high, anxious, elated, hungry, and nauseated. The elated subscale is reported, and this sub scale is anchored by not at all (0) on the left and extremely (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
2696632|NCT01267292|Secondary|"Subjective Effects as Assessed by Score on the Feel High Subscale of the Drug Effects Questionnaire (DEQ)"|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. The Feel High subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
2696633|NCT01267292|Secondary|Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS)|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. The six subscales are: depression, vigor, confusion, tension, anxiety, and fatigue. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
2696634|NCT01267292|Secondary|Subjective Effects as Assessed by the Addiction Research Center Inventory (ARCI)|The ARCI short form will be used. It is a 49-item true / false questionnaire that has been empirically-derived to assess five different factors, including euphoria, sedation, and dysphoria. The PCAG scale has proven to be a sensitive measure of subjective effects in many studies administering stimulant drugs.|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|ARCI data were not collected.||||||
2696635|NCT01267292|Primary|Risky Decision Making as Assessed by Score on the Risky Decision Making Task|"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.~The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk."|1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
2696636|NCT01267292|Primary|Attentional Bias as Assessed by Score on the Stroop Task|"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.~The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words."|1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3||||milliseconds||Standard Deviation|Mean
2696637|NCT01267279|Primary|Bone Mineral Density (BMD)|Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.|2 years post-operative||||Percent change||Standard Deviation|Mean
2696638|NCT01267266|Secondary|Correlation of Molecular Profile With Clinical Outcomes|Study terminated after randomization of only 8 subjects. Correlative data not analyzed.|Up to 2 years|||||||
2696639|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events.|Percentage of patients who discontinued therapy due to toxicity.|Up to 6 months.||||percentage of participants||95% Confidence Interval|Number
2696640|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events|Percentage of patients with grade 4 toxicity.|Up to 6 months.||||percentage of participants||95% Confidence Interval|Number
2696641|NCT01267266|Primary|Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)|Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.|Up to 6 months.|Two patients in the placebo arm censored at 12 and 17 weeks, respectively.|||weeks||Full Range|Median
2696642|NCT01267253|Other Pre-specified|Serum Expression Levels of Surrogate Markers of Brivanib Alaninate Effects Including Angiogenic Factors (VEGF and bFGF) and Markers of Endothelial Damage (E-selectin, VCAM-1, and ICAM-1)|Surrogate markers will be associated with response, PFS, and OS.|Up to 5 years|||||||
2696643|NCT01267253|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact..|From study entry to time of death or the date of last contact, up to 5 years of follow-up.|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
2696644|NCT01267253|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up|Eligible and Treated Participants|||Months||95% Confidence Interval|Median
2696645|NCT01267253|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0|During treatment period and up to 30 days after stopping the study treatment.|Eligible and Treated Participants|||Participants|||Number
2696646|NCT01267253|Primary|PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry.|Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and treated participants|||proportion||90% Confidence Interval|Number
2696647|NCT01267253|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated participants|||proportion||90% Confidence Interval|Number
2696648|NCT01267240|Secondary|Progression-free Survival|"PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions."|From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.|16 of 25 patients were evaluable for response.|||months||95% Confidence Interval|Median
2696649|NCT01267240|Secondary|Survival|Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.|Up to 1 year|16 patients of the 25 were eligible for response assessment.|||months||95% Confidence Interval|Median
2696650|NCT01267240|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.|Up to 1 year||||participants|||Number
2696651|NCT01267227|Secondary|Subjective Adverse Effects|Number of participants with adverse effects as a measure of safety|Baseline and 6-8 weeks||||participants|||Number
2696652|NCT01267227|Secondary|Blood Pressure|Reduction in systolic blood pressure versus placebo|6-8 weeks||||mmHg||95% Confidence Interval|Mean
2696653|NCT01267227|Primary|LDL|Increase in low density lipoprotein (LDL)|Baseline and 6-8 weeks||||mg/dL||95% Confidence Interval|Mean
2696654|NCT01267201|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2696655|NCT01267201|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hr||Full Range|Median
2696656|NCT01267201|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2696657|NCT01267201|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2696658|NCT01267175|Secondary|Usability of the Training Material Meets Expectations|Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly.|5 weeks||||Scores on a scale||Standard Deviation|Mean
2696659|NCT01267175|Primary|Usability of the X54 Insulin Pump Meets Expectations|Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.|5 weeks||||Scores on a scale||Standard Deviation|Mean
2711596|NCT01161862|Secondary|Percentage of Time Spent With Blood Glucose <70 mg/dl||48 hours|Overall number of participants=24 (12 in each arm)|||percentage of total time||Standard Deviation|Mean
2696661|NCT01267136|Primary|Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.|Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).|Efficacy was assessed daily during the 10-day postoperative recovery period.||||days||Full Range|Median
2696662|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|"The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. I disapprove of myself when I have irrational ideas) by indicating how often they agree with the statement on a scale of 1 (never or very rarely true) to 5 (very often or always true). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness."|8 months||||units on a scale||Standard Deviation|Mean
2696663|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|"The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. I disapprove of myself when I have irrational ideas) by indicating how often they agree with the statement on a scale of 1 (never or very rarely true) to 5 (very often or always true). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness."|2 months||||units on a scale||Standard Deviation|Mean
2696664|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. How often did you feel tired?) with the following scale:~= never~= rarely~= sometimes~= often~= always~Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|8 months||||T-score||Standard Deviation|Mean
2696665|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. How often did you feel tired?) with the following scale:~= never~= rarely~= sometimes~= often~= always~Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|2 months||||T-score||Standard Deviation|Mean
2696666|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|"The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?) by indicating how often per week he or she experiences that symptom. For each item, not at all is scored as 0; once per week or less/a little is scored as 1; 2 to 4 times per week/somewhat is scored as 2; and 5 or more times per week/very much is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome."|8 months||||units on a scale||Standard Deviation|Mean
2696667|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|"The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?) by indicating how often per week he or she experiences that symptom. For each item, not at all is scored as 0; once per week or less/a little is scored as 1; 2 to 4 times per week/somewhat is scored as 2; and 5 or more times per week/very much is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome."|2 months||||units on a scale||Standard Deviation|Mean
2696668|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|"The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. feeling tired or having little energy), from not at all (0), to nearly every day (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome."|8 months||||units on a scale||Standard Deviation|Mean
2696669|NCT01267045|Primary|Cognitive Failures Questionnaire|"The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. Do you find you forget why you went from one part of the house to another?), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome."|8 months||||units on a scale||Standard Deviation|Mean
2696670|NCT01267045|Primary|Cognitive Failures Questionnaire|"The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. Do you find you forget why you went from one part of the house to another?), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome."|2 months||||units on a scale||Standard Deviation|Mean
2696671|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|8 months||||units on a scale||Standard Deviation|Mean
2696672|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|2 months||||units on a scale||Standard Deviation|Mean
2696673|NCT01267045|Primary|The Short-Form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|8 months||||units on a scale||Standard Deviation|Mean
2696674|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|"The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. feeling tired or having little energy), from not at all (0), to nearly every day (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome."|2 months||||units on a scale||Standard Deviation|Mean
2696675|NCT01267045|Primary|The Short-form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|2 months||||units on a scale||Standard Deviation|Mean
2696676|NCT01267019|Secondary|Profile of Nonverbal Sensitivity (PONS)|"A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110.~Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.||||units on a scale||Standard Deviation|Mean
2696677|NCT01267019|Secondary|The Awareness of Social Inference Test (TASIT)|"A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64.~Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.||||units on a scale||Standard Deviation|Mean
2696678|NCT01267019|Primary|Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)|"A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better.~Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.||||units on a scale||Standard Deviation|Mean
2696679|NCT01266993|Secondary|Number of Subjects With Serious Adverse Events SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|Up to Month 32, 44, 56 and 68|The analysis was performed on the Total Vaccinated cohort at Months 32, 44, 56 annd 68, which included all vaccinated subjects in the primary 111414 study (NCT00674583) who came back for persistence visit at Months 32, 44, 56 and 68, respectively.|||Participants|||Count of Participants
2696680|NCT01266993|Secondary|Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs)|New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies.|During the 31-day (Days 0-30) period following the booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.|||Participants|||Count of Participants
2696681|NCT01266993|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the 31-day (Days 0-30) period following the booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.|||Participants|||Count of Participants
2696682|NCT01266993|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) period following the booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.|||Participants|||Count of Participants
2696683|NCT01266993|Secondary|Number of Subjects With Any, Grade 3 and Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = Fatigue that prevented normal activity. Grade 3 Gastrointestinal symptoms = Gastrointestinal symptoms that prevented normal everyday activities. Grade 3 Headache = Headache that prevented normal acitivity. Grade 3 Fever = Rectal temperature higher than (>) 39.5°C.|During the 4-day (Days 0-3) period following the booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2696684|NCT01266993|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 50 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity."|During the 4-day (Days 0-3) period following the booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2696957|NCT01265550|Secondary|Number of Enrolled Participants With Functional Diarrhea||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional diarrhea|||Participants|||Count of Participants
2696685|NCT01266993|Secondary|Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY was defined as hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titers <1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titers ≥1:4).|At Month 69, one month post-booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2696686|NCT01266993|Secondary|Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers <1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥1:8).|At Month 69, one month post-booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2696687|NCT01266993|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 69, one month post-booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2696688|NCT01266993|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values|The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 69, one month post-booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2696689|NCT01266993|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 69, one month post-booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2696690|NCT01266993|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Values|The pre-defined cut-off values of the assay for the rSBA titers were greater than or equal to (≥) 1:128 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 69, one month post-booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2696691|NCT01266993|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 68, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.|||Titers||95% Confidence Interval|Geometric Mean
2696692|NCT01266993|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.|At Month 56, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.|||Titers||95% Confidence Interval|Geometric Mean
2696693|NCT01266993|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.|At Month 44, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.|||Titers||95% Confidence Interval|Geometric Mean
2696694|NCT01266993|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.|At Month 32, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.|||Titers||95% Confidence Interval|Geometric Mean
2696744|NCT01266876|Secondary|Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.|||mg/dL||Standard Error|Least Squares Mean
2696695|NCT01266993|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values|The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed in all subjects, by the Health Protection Agency (HPA) laboratory.|At Month 68, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.|||Participants|||Count of Participants
2696696|NCT01266993|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values|The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.|At Month 56, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.|||Participants|||Count of Participants
2696697|NCT01266993|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values|The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.|At Month 44, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.|||Participants|||Count of Participants
2696698|NCT01266993|Secondary|Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values|The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.|At Month 32, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.|||Participants|||Count of Participants
2696699|NCT01266993|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 68, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.|||Titers||95% Confidence Interval|Geometric Mean
2696700|NCT01266993|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 56, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.|||Titers||95% Confidence Interval|Geometric Mean
2696701|NCT01266993|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 44, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.|||Titers||95% Confidence Interval|Geometric Mean
2696702|NCT01266993|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.|At Month 32, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.|||Titers||95% Confidence Interval|Geometric Mean
2696703|NCT01266993|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 68, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.|||Participants|||Count of Participants
2696704|NCT01266993|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 56, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.|||Participants|||Count of Participants
2696705|NCT01266993|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 44, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.|||Participants|||Count of Participants
2696706|NCT01266993|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 32, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.|||Participants|||Count of Participants
2696707|NCT01266993|Primary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 68, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.|||Participants|||Count of Participants
2696708|NCT01266993|Primary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 56, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.|||Participants|||Count of Participants
2696709|NCT01266993|Primary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 44, post-primary vaccination|The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.|||Participants|||Count of Participants
2696710|NCT01266993|Primary|Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Above the Cut-off Value|The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.|At Month 32, post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.|||Participants|||Count of Participants
2696711|NCT01266967|Secondary|Number of Response Genetics Incorporated (RGI) Investigational Use Only (IUO) Assay Mutation Positive Participants and THxID BRAF Assay Mutation Positive Participants With the Indicated Best Intracranial Response|The BRAF screening assay determines the specific BRAF mutational status (V600 E and K) in participants with metastatic melanoma who may benefit from treatment with GSK2118436. Per RECIST, version 1.1, CR is defined as the disappearance of all lesions. PR is defined as a >=30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline (BL) sum of the diameters (e.g., percent change from BL). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a >=20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir [smallest sum of diameters recorded since treatment start]). In addition, the sum must have an absolute increase from nadir of 5 millimeters. Not evaluable: cannot be classified by a preceding definition.|Screening|V600EK and THIDEK Population: all enrolled participants who were V600E or V600K mutation positive by the RGI IUO assay|||participants|||Number
2696712|NCT01266967|Secondary|Composite of Pharmacokinetic Parameters of GSK2118436 in a Subset of Participants Receiving Dexamethasone|This outcome measure could not be analyzed because too few participants participated in the dexamethasone study.|Day 15|||||||
2696713|NCT01266967|Secondary|Median Concentrations of GSK2118436 and Its Metabolites Including GSK2285403, GSK2298683, and GSK2167542|Summary statistics were calculated for each time point by cohort. The population pharmacokinetics were determined using a non-linear mixed effects modeling approach after pooling the data with other studies. These results are reported separately.|Week 4 (pre-dose and 1-3 hours post-dose) and Weeks 8, 16, 24, and 32 (either pre-dose in the morning or in the afternoon at 4-8 hours post-dose)|PK Population: participants in the ATS population for whom a PK sample was obtained and analyzed. Only those participants whose samples were available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Full Range|Median
2696714|NCT01266967|Secondary|Number of Participants With Abnormal Echocardiograms (ECHO) at Weeks 4 and 12|Echocardiograms (ECHO) were measured for all treated participants. An echocardiogram test gives information about the structure and function of the heart. LLN=lower limit of normal (determined by the institution).|Weeks (W) 4 and 12|ATS Population|||participants|||Number
2696715|NCT01266967|Secondary|Number of Participants With a Worst-case On-therapy Increase From Baseline in Bazett's QTc Reading in the 12-lead Electrocardiogram (ECG)|An increase in the QTc interval corrected using Bazett's formula (Bazett's QTc) was recorded for all treated participants. Grade 1 (450-480 milliseconds [msec]), Grade 2 (481-500 msec), Grade 3/4 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade.|Baseline; Weeks 4, 12, 20, 28, 40, 52, and 64|ATS Population. Only those participants with data available at the indicated time points were analyzed.|||participants|||Number
2696716|NCT01266967|Secondary|Mean Blood Pressure at Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|Systolic and diastolic blood pressure were measured for all treated participants.|Baseline; Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|ATS Population. Only those participants with data available at the indicated time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2711597|NCT01161862|Secondary|Percentage of Time Spent With Blood Glucose < 60 mg/dl||48 hours|Overall number of participants=24 (12 in each arm)|||percentage of total time||Standard Deviation|Mean
2696717|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Hematology Parameters|Hematology data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe, Grade 4, life threatening, Grade 5, death related to toxicity. Blood sample was collected for the assessment of hemoglobin, white blood cells, and platelet count.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.|||participants|||Number
2696718|NCT01266967|Secondary|Number of Participants With the Indicated Hepatobiliary Laboratory Abnormalities|Blood samples were collected for the assessment of hepatobiliary parameters. ALT=alanine aminotranserase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; BIL=total bilirubin; INR=international normalized ratio; ULN=upper limit of normal. Hepato-cellular injury is defined as (ALT/ULN)/(ALP/ULN) >=5.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population|||participants|||Number
2696719|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Clinical Chemistry Parameters|Clinical chemistry data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade (G) 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death related to toxicity. Blood sample was collected for the assessment of glucose, potassium, magnesium, sodium, phosphorus, potassium. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatinine, total bilirubin, albumin, amylase, cholesterol, creatine kinase, gamma glutamyl transferase (GGT), lipase, blood pH, and triglycerides.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.|||participants|||Number
2696720|NCT01266967|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From Screening until the conclusion of the study (up to 103 weeks)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment|||participants|||Number
2696721|NCT01266967|Secondary|Overall Survival in V600K Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 26 weeks)|V600K Population|||months||95% Confidence Interval|Median
2696722|NCT01266967|Secondary|Overall Survival of V600E Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 35 weeks)|V600E Population|||months||95% Confidence Interval|Median
2696723|NCT01266967|Secondary|Progression-free Survival in V600K Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 17 weeks)|V600K Population|||weeks||95% Confidence Interval|Median
2696724|NCT01266967|Secondary|Progression-free Survival in V600E Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 23 weeks)|V600E Population|||weeks||95% Confidence Interval|Median
2696745|NCT01266876|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.|||percent change||Standard Error|Least Squares Mean
2696725|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600K Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial response was included in this analysis.|||weeks||95% Confidence Interval|Median
2696726|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600E Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 28 weeks)|V600E Population. Only the subset of participants who had a complete or partial response was included in this analysis.|||weeks||95% Confidence Interval|Median
2696727|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600K Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.|||weeks||95% Confidence Interval|Median
2696728|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600E Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 27 weeks)|V600E Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.|||weeks||95% Confidence Interval|Median
2696729|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With OIR, as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PF) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 16 weeks)|V600K Population|||participants|||Number
2696730|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 17 weeks)|V600K Population: all participants with BRAF V600K mutation-positive melanoma who received at least one dose of study treatment|||participants|||Number
2696746|NCT01266876|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.|||mg/dL||Standard Error|Least Squares Mean
2696731|NCT01266967|Secondary|Number of Participants With V600E Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 24 weeks)|V600E Population|||participants|||Number
2696732|NCT01266967|Primary|Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks)|V600E Population: all participants with BRAF V600E mutation-positive melanoma who received at least one dose of study treatment|||participants|||Number
2696733|NCT01266876|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.|||mg/dL||Inter-Quartile Range|Median
2696734|NCT01266876|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.|||percent change||Inter-Quartile Range|Median
2696735|NCT01266876|Secondary|Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.|||ratio||Standard Error|Least Squares Mean
2696736|NCT01266876|Secondary|Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.|||mg/dL||Standard Error|Least Squares Mean
2696737|NCT01266876|Secondary|Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.|||percent change||Standard Error|Least Squares Mean
2696738|NCT01266876|Secondary|Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.|||mg/dL||Standard Error|Least Squares Mean
2696739|NCT01266876|Secondary|Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.|||percent change||Standard Error|Least Squares Mean
2696740|NCT01266876|Secondary|Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.|||mg/dL||Standard Error|Least Squares Mean
2696741|NCT01266876|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.|||percent change||Standard Error|Least Squares Mean
2696742|NCT01266876|Secondary|Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.|||mg/dL||Inter-Quartile Range|Median
2696743|NCT01266876|Secondary|Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.|||percent change||Inter-Quartile Range|Median
2711598|NCT01161862|Primary|Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)||48 hours|Overall number of participants was 24, 12 in each arm|||mg/dl||Standard Deviation|Mean
2696747|NCT01266876|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.|||percent change||Standard Error|Least Squares Mean
2696748|NCT01266876|Secondary|Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.|||percentage of participants|||Number
2696749|NCT01266876|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.|||percentage of participants|||Number
2696750|NCT01266876|Secondary|Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.|||mg/dL||Standard Error|Least Squares Mean
2696751|NCT01266876|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2696752|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2696753|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3|Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2696754|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2696755|NCT01266850|Primary|Geometric Mean Serum Anti-rotavirus IgA Titer|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Mean
2696756|NCT01266850|Secondary|Number of Participants Experiencing Hematochezia at Any Time During the Study|Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia.|Day 1 through 6 months after the last vaccination|All participants who were vaccinated are included in the analysis population.|||participants|||Number
2696757|NCT01266850|Secondary|Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination|The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day.|Days 1-8 after each vaccination|All participants who were vaccinated and had reactogenicity data reported are included in the analysis population.|||participants|||Number
2696758|NCT01266850|Secondary|GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9)|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Mean
2696759|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2696760|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2696761|NCT01266824|Secondary|PIPP Score|PIPP score measure immediately following mydriatic drop administration|within 5 minutes after Mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
2696762|NCT01266824|Secondary|Bradycardia/Desaturation|Number of episodes of bradycardia (HR 90) and significant desaturation (event requiring stimulation, per Neonatal Intensive Care Unit (NICU) protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops|Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
2696763|NCT01266824|Secondary|PIPP Score|PIPP scores measure immediately after Proparacaine administration|within 5 minutes after Proparacaine administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
2696764|NCT01266824|Primary|Change in PIPP Score|Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score >7 typically indicates a pain response while a score >12 indicates more severe pain.|Change from baseline to time immediately following mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
2696765|NCT01266603|Secondary|Progression-free Survival|To evaluate the rate of stable disease, progression-free survival and the overall survival of patients with MAGE-A3- positive, unresectable or metastatic melanoma who received the combination of HDIL-2 and recMAGE-A3 + AS15 ASCI.|Until treatment completed or up to 3 years & 9 months.||||Months||95% Confidence Interval|Median
2696766|NCT01266603|Secondary|Rate of SAEs|To evaluate the safety and toxicity profile of HDIL-2 in combination with recMAGE-A3 + AS15 ASCI in participants with MAGE-A3-positive, unresectable or metastatic melanoma|Until treatment completed or up to 3 years & 9 months||||participants|||Number
2696767|NCT01266603|Primary|Objective Response Rate|To evaluate the objective response rate induced by the concurrent administration of HDIL-2 and recMAGE-A3 + AS15 ASCI in patients with MAGE-A3-positive, unresectable or metastatic melanoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Until disease progression or up to 3 years & 9 months||||percentage of participants|||Number
2696768|NCT01266590|Primary|Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt)|AUCt at steady state of digoxin when administered alone and when co-administered with LY2216684.|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14|All participants who received at least 1 dose of study drug and evaluable AUCt values.|||hours*nanograms/milliliter (h*ng/mL)||90% Confidence Interval|Geometric Mean
2696769|NCT01266590|Primary|Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax)|Tmax of digoxin when administered alone and when co-administered with LY2216684.|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14|All participants who received at least 1 dose of study drug and had evaluable Tmax values.|||hours||Full Range|Median
2696770|NCT01266590|Primary|Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax)|Cmax of digoxin when administered alone and when co-administered with LY2216684.|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14|All participants who received at least 1 dose of study drug and had evaluable Cmax values.|||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2696771|NCT01266447|Secondary|Duration of Objective Response|Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months.|Eligible and Treated Patients with objective response|||Months||Full Range|Median
2696773|NCT01266447|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2696774|NCT01266447|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months.|Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period.|||Participants|||Number
2696775|NCT01266447|Primary|Number of Patients With Dose-limiting Toxicities (in Safety lead-in)|A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting >7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea & vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for >48 hours despite maximum medical management, electrolyte imbalance of > or equal to grade 3 that can be replaced within 48 hours; any drug related death|Up to 21 days|The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment|||participants|||Number
2696776|NCT01266447|Primary|Tumor Response|Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2696777|NCT01266317|Secondary|Number of Participants Survived to 60 Days or to Transplantation|The secondary outcome measures a composite outcome defined as survival to 60 days or survival to transplantation at any time post therapy.|60 days||||Participants|||Count of Participants
2696778|NCT01266317|Primary|Number of Participants With Respiratory and/or Hemodynamic Deteriorations|To assess the feasibility and safety of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function during the treatment interval. Respiratory deterioration was defined by a compilations of respiratory deteriorations (deteriorating gas exchange) and hemodynamic deteriorations (defined as a need for medical intervention).|28 days||||Participants|||Count of Participants
2696779|NCT01266291|Secondary|Number of Patients Who Become Seizure Free While Taking Sabril|"Seizure freedom~Responder rate (complex partial seizures only)"|Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5)|One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.|||Participants|||Count of Participants
2696780|NCT01266291|Primary|Number of Participants Safely Tolerating Sabril|"Antiepileptic Drug (AED) levels in blood~Comprehensive panel (blood test)~Complete Blood Count with differential (blood test)~Visual field tests testing~Ophthalmology exam assessment~Frequency and severity of adverse events reported by subjects throughout their involvement with the study"|Outcome measures will be assessed at the initiation of Sabril (titration), and at three and five months after starting Sabril. After this time, the subjects will have completed the study.|One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.|||Participants|||Count of Participants
2696781|NCT01266265|Primary|Prevalence of Respiratory Tract-Related Adverse Events of Interest|Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.|Follow-up every 3 months||||percentage of participants|||Number
2696782|NCT01266161|Secondary|Participant Global Evaluation Score|"Participants responded, on a 6-point categorical scale, to the following question: How would you rate this medication as a pain-reliever? Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|24 and 48 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696783|NCT01266161|Secondary|Time to Meaningful Relief|Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.|Baseline to 12 hours|ITT population. Here, “Number of participants analysed signifies those participants who were evaluable for this outcome measures”.|||minutes||95% Confidence Interval|Median
2696841|NCT01265953|Primary|Change of Total Urine SFN (Sulforaphane) Metabolites|Collection of blood and urine specimens occurred at pre-intervention and post-intervention. Change = post-intervention level minus pre-intervention level|Baseline and 4-8 weeks following intervention|Not all subjects had urine samples for analysis, therefore, the total number of subjects in this urine analysis is different from total number of enrolled subjects.|||micromolar (µM) concentrations of urina||Standard Error|Mean
2696784|NCT01266161|Secondary|Time to Confirmed First Perceptible Relief|The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.|Baseline to 12 hours|ITT population. Here, “Number of participants analysed signifies those participants who were evaluable for this outcome measures”.|||minutes||95% Confidence Interval|Median
2696785|NCT01266161|Secondary|Number of Doses of Rescue Medication Used||0-12, 12-24, 24-36, 36-48, 0-48 hours|ITT population|||doses||Standard Deviation|Mean
2696786|NCT01266161|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR)|"TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best)."|0-12 hours, 8-12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696787|NCT01266161|Secondary|Pain Relief Combined With Pain Intensity (PRID) Scores|"PRID score=PR plus PID. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: How much pain do you have at this time? (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity."|0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696788|NCT01266161|Secondary|Pain Intensity Difference (PID) Scores|"For pain intensity, How much pain do you have at this time? answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity)."|0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696789|NCT01266161|Secondary|Pain Relief (PR) Scores|"A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: How much relief do you have from your starting pain? Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief."|0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696790|NCT01266161|Secondary|Percentage of Participants Taking Rescue Medication|Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.|Baseline to 48 hours|ITT population|||percentage of participants|||Number
2696791|NCT01266161|Secondary|Time to First Dose of Rescue Medication After First Dose of Study Drug|During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.|Baseline to 12 hours|ITT population. Here, “Number of participants analysed signifies those participants who were evaluable for this outcome measures”.|||hours||95% Confidence Interval|Median
2696792|NCT01266161|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) Scores|"SPID is a derived endpoint from PID scores. For pain intensity, How much pain do you have at this time? answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity."|0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696793|NCT01266161|Primary|Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose|"SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: How much pain do you have at this time? (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy."|8 to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2696794|NCT01266161|Primary|Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)|"SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0 equals [=] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: How much pain do you have at this time? (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy."|Baseline to 12 hours|Intent-to-treat (ITT) population: Randomized participants with at least moderate baseline pain (score 2 on the pain severity rating [PSR] scale) confirmed by a score of at least 50 millimeter (mm) on the 100-mm visual analog scale (VAS)-PSR, within approximately 5 hours after surgery, provided a baseline assessment, and received study medication.|||units on a scale||Standard Deviation|Mean
2696842|NCT01265875|Secondary|VAS Score at Each Administered Dose.|10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.|Days 1, 2, and 3.||||units on a scale||Standard Deviation|Mean
2696795|NCT01266148|Secondary|Change in Quality of Life - Euro Quality of Life 5D (EQ-5D)|Change in Quality of Life was assessed via the EQ-5D questionnaire which consists of: EQ-5D-5L descriptive system and EQ Visual Analogue scale (EQ VAS). The EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The patient indicates his/her health state by checking the most appropriate statement. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions are combined in a 5-digit number describing the respondent's health state. The possible score is 1 to 5 where a lower number indicates improvement. The EQ VAS records the patient's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The score is 0 to 100 where a higher score represents improvement.|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2696796|NCT01266148|Secondary|Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment|Change in Quality of Life was assessed via the SF-36 (Minnesota Living with Heart Failure questionnaire ([MLHF)]) before transplant surgery and at week 52 of treatment. The SF-36 is a validated, self-administered questionnaire. The questionnaire, which includes 36 questions measures 8 dimensions of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. Scores can be summarized in 2 summary components assessing physical and mental health. Items in each dimension are coded, aggregated, summed, and transformed into a scale ranging from 0 (worse health) to 100 (best health).|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2696797|NCT01266148|Secondary|Lipid Profile at 12 Months|Total Cholesterol, LDL-Chol, HDL-Chol and TG at week 52. Measurements were taken via participants blood samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and had blood samples taken at week 52.|||mmol/L||Standard Deviation|Mean
2696798|NCT01266148|Secondary|Average Level of Protenuria at Week 52|Proteinuria is measured as the ratio of albumin/creatinine mg/mmol. Measurements were taken from participants urine samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and were able to provide urine samples at week 52.|||mg/mmol||Standard Deviation|Mean
2696799|NCT01266148|Secondary|Occurrence of Treatment Failures up to 12 Months After Transplant|Treatment failure was defined as the number of participants who died or lost their graft at any timepoint througout the duration of the study.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||participants|||Number
2696800|NCT01266148|Secondary|Number of Rejections Leading to Hemodynamic Compromise|Number of all rejections were recorded through the duration of the study with the intent to identify rejections leading to hemodynamic compromise.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||rejections|||Number
2696801|NCT01266148|Secondary|Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52|Calculated Glomerular Filtration Rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end of week 52.|Day 1, weeks 7 to 11 and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mGFR mL/min||Standard Deviation|Mean
2696802|NCT01266148|Secondary|Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52|Change in calculated glomerular filtration rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end week 52.|Day 1, weeks 7 to 11(baseline) and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mGFR mL/min||Standard Deviation|Mean
2696803|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52|the progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examinations, measured the incidence of CAV (in percent of patients) at baseline and at week 52. Incidence of CAV represents percent of patients having a MIT (maximal intima thickness) > 0.5 mm.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||Percentage of patients|||Number
2696804|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52|The progression of chronic allograft vasculopathy (CAV) was assessed by intravascular ultrasound (IVUS) examinations and measured Maximal Intimal Thickness (MIT)(in mm). A major coronary epicardial artery (preferentially the left-anterior descending coronary artery) was imaged, and the MIT parameters were recorded at baseline and at week 52.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mm||Standard Deviation|Mean
2696805|NCT01266148|Primary|Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation|Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants' urine was used for this assessment at week 52 after heart transplant.|Week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mGFR ml/min||Standard Deviation|Mean
2696806|NCT01266122|Secondary|Changes in Psychosocial Mediators|We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.|up to 6 months|||||||
2696807|NCT01266122|Secondary|Acquisition of STIs - Number of Participants That Acquired STIs|We will test for locally relevant STIs at baseline and 6 months.|6 months||||participants|||Number
2696808|NCT01266122|Primary|Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant|We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.|up to 6 months||||number of unprotected sex acts||Standard Deviation|Mean
2696809|NCT01266070|Secondary|Number of VHL Participants With Response at 6 Months|Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.|Every 2 cycles (approximately 8 weeks) for 6 months||||Participants|||Count of Participants
2696810|NCT01266070|Primary|Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months|Most frequent & Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.|Every 2 cycles (approximately 8 weeks) for 6 months||||Participants|||Count of Participants
2696811|NCT01266031|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle.||||Participants|||Count of Participants
2696812|NCT01266031|Secondary|Radiological Response|Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).|End of therapy, approximately|This outcome measure was not done. We collected radiological response data provided by the local physician at time points per protocol. At the end of the study, the plan was to send all MRI discs to one radiologist for central review to confirm responses. With only limited funding, and negative findings, the PI decided to not pursue this outcome.||||||
2696813|NCT01266031|Secondary|Mean Symptom Interference at the Time of Clinical Evaluation|"Overall mean interference severity of 6 interference items. Interference is rated 0-10, zero is did not interfere and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses."|Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)|Overall analysis was done but not done by treatment arm/group.|||score on a scale||Standard Deviation|Mean
2696814|NCT01266031|Secondary|Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool|"Overall mean severity of 22 symptoms. Symptoms are rated 0-10, zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses."|Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)|Overall analysis was done but not done by treatment arm/group.|||score on a scale||Standard Deviation|Mean
2696815|NCT01266031|Secondary|Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool|"Percentage of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12)|Reason outcome measure #7 is not done per arm/group is it was intentionally not completed due to negative findings of the study’s primary outcomes.|||percentage of of participants|||Number
2696816|NCT01266031|Secondary|Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Stromal Cell-derived Factor α (SDF1α), and Angiopoietin 1 (Ang 1) and 2 (Ang 2) by Enzyme-linked Immunosorbent Assay (ELISA)|About 5cc of blood was collected to measure plasma angiogenic proteins stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA).|Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)|This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.||||||
2696817|NCT01266031|Secondary|Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Vascular Endothelial Growth Factor (VEGF), Placental Growth Factor (PIGF), and Basic Fibroblast Growth Factor (bFGF)|About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), and basic fibroblast growth factor (bFGF) by enzyme-linked immunosorbent assay (ELISA).|Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)|This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.||||||
2696818|NCT01266031|Secondary|Overall Survival (OS)|OS was computed using the number of months from the date of randomization to the date of death, up to 30 months. Participants still alive were censored at the last follow-up date.|up to 30 months.||||Months||95% Confidence Interval|Median
2696819|NCT01266031|Secondary|Time to Progression (TTP)|Progression defined by the Modified MacDonald criteria is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).|3, 6, and 12 months from patient registration||||Months||95% Confidence Interval|Median
2696820|NCT01266031|Primary|Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab|MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0.|28 day, cycle 1||||mg/day|||Number
2696821|NCT01266031|Primary|Progression Free Survival (PFS) at 6 Months|"PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year.~Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.~Study outcome measure period ended June 2015."|Baseline until disease progression or death due to any cause, up to six months||||Months||95% Confidence Interval|Median
2696822|NCT01266018|Secondary|Assessment of Overall Survival|Overall survival was measured from the initial date of treatment to the recorded date of death. Because the study was terminated prematurely, no statistical analyses of overall survival data were performed.|Every 4 weeks for up to 16 months|Subjects who had survival status recorded during post-study follow-up.|||Participants|||Count of Participants
2696823|NCT01266018|Secondary|Assessment of Immunogenicity of ADI-PEG 20|Blood samples were collected for all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in ADI-PEG 20 antibody titer in peripheral blood over time. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.|Every 1 to 4 weeks for up to 16 weeks|The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.|||log 10 IU/mL||Full Range|Mean
2696824|NCT01266018|Secondary|Assessment of Pharmacodynamics of ADI-PEG 20|Blood samples were collected from all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in plasma arginine and citrulline levels following administration of ADI-PEG 20. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.|Every 1 to 4 weeks for up to 16 weeks|The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.|||uM||Full Range|Mean
2696825|NCT01266018|Secondary|Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.|Every 1 to 4 weeks for up to 16 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
2696826|NCT01266018|Primary|Best Overall Response|"Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI:~Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria."|Every 4 to 8 weeks for up to 16 weeks|Includes all patients who were evaluable for tumor response allocation.|||participants|||Number
2696827|NCT01265992|Secondary|Number of Participants Using Concomitant Medications at Baseline||Baseline|Full analysis set|||participants|||Number
2696828|NCT01265992|Secondary|Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism|"Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days.~Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment.~Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature."|6 months|Participants who were working for pay and with available data at both time points.|||Swedish krona per participant||Standard Deviation|Mean
2696829|NCT01265992|Secondary|Total Direct Costs of Care Associated With Secondary Hyperparathyroidism|Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.|6 months|||||||
2696830|NCT01265992|Secondary|Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)|"The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 (worst possible health) to 10 (best possible health).~Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life."|Baseline and 6 months|Per-protocol analysis set with available data at both time points.|||units on a scale||Standard Deviation|Mean
2696831|NCT01265992|Secondary|Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline||Baseline and 6 months|Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set.|||percentage of participants|||Number
2696832|NCT01265992|Secondary|Change From Baseline in Proteinuria|Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.|Baseline and Month 6|Per-protocol analysis set with available data at both time points.|||g/L||Standard Deviation|Mean
2696833|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months|Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.|Baseline and 6 months|Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).|||percentage of participants|||Number
2696834|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months|"Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as:~Stage 3 CKD: ≥ 1.49 mmol/L;~Stage 4 CKD: ≥ 1.49 mmol/L;~Stage 5 CKD: > 1.78 mmol/L."|Baseline and 6 months|Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).|||percentage of participants|||Number
2696835|NCT01265992|Primary|Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months|"Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are:~Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 - 59 mL/min): 3.85 - 7.7 pmol/L;~Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L;~Stage 5 CKD (eGFR < 15 mL/min): 16.5 - 33 pmol/L.~*Calculated using the Modification of Diet in Renal Disease formula."|Baseline and 6 months|Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).|||percentage of participants|||Number
2696836|NCT01265992|Primary|Change From Baseline in Intact Parathyroid Hormone at 6 Months||Baseline and 6 months|Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.|||pmol/L||Standard Deviation|Mean
2696837|NCT01265966|Primary|Change From Baseline to Peak Salivary Cortisol Level|Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.|Baseline, then every 30 minutes, and at end of procedure|All patients with adequate samples for analysis.|||Number (ratio of peak to baseline)||Standard Error|Mean
2696838|NCT01265953|Primary|Expression of Histone Deacetylase 6 (HDAC6)|Immunohistochemical (IHC) analysis of HDAC6 expression using research-only prostate biopsy tissue collected post-intervention at the time of the clinically-indicated prostate biopsy. A modified Histo-score (H-score) was calculated, which involved semiquantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate, and 3 strong) and percentage of positive cells. H-score ranged from 0 to 300 with 300 the strongest expression.|Baseline and 4-8 weeks following intervention; prostate biopsy were collected post-intervention when clinically-indicated|Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.|||H-score||Standard Error|Mean
2696839|NCT01265953|Primary|Percentage of Ki67 Positive Cells up to 8 Weeks Post-randomization|Ki67 is a biomarker of disease progression. Immunohistochemical (IHC) analysis of Ki67 was performed using research only prostate biopsy specimens collected post-intervention at the time of the clinically-indicated prostate biopsy.|Baseline and 4-8 weeks following intervention; prostate biopsy were collected post-intervention when clinically-indicated|Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.|||percent positive||Standard Error|Mean
2696840|NCT01265953|Primary|Change of Total Plasma SFN (Sulforaphane) Metabolites Level|In subjects at risk for prostate cancer, presence of SFN was analyzed in plasma. Collection of blood specimens occurred at pre-intervention and post-intervention. The Change = post-intervention level minus pre-intervention level|Baseline and 4-8 weeks following intervention|We missed blood samples from some subjects, therefore, total number of subjects analyzed for the plasma-based analysis is different from the number of total enrolled subjects.|||micromolar (µM)||Standard Error|Mean
2696843|NCT01265875|Primary|Quality of Life at Baseline, Day 4 and Day 30.|Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.|Baseline, Day 4, Day 30.||||units on a scale||Standard Deviation|Mean
2696853|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT population|||percentage of participants|||Number
2696854|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT Population|||percentage of participants|||Number
2696855|NCT01265823|Secondary|Mean Homocysteine Levels at Baseline and Week 16|Normal values for homocysteine were 5-13.9 µmol/L.|Baseline, Week 16|Participants with available data at given time points.|||µmol/L||Standard Deviation|Mean
2696856|NCT01265823|Secondary|Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16|Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.|Baseline, Week 16|Participants with available data at given time points.|||mg/dL||Standard Deviation|Mean
2696857|NCT01265823|Secondary|Physician's Global Assessment (PGA) at Week 16|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.|Week 16|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
2696858|NCT01265823|Secondary|Physician's Global Assessment (PGA) at Week 4|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).|Week 4|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
2696859|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 16|ITT population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
2696860|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 4|ITT population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
2696861|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 16|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
2696862|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 4|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
2696958|NCT01265550|Secondary|Number of Enrolled Participants With Functional Bloating||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional bloating|||Participants|||Count of Participants
2696863|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 16|Participants with evaluable data at given time points.|||units on a scale||Standard Deviation|Mean
2696864|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 4|Participants with evaluable data at given time points.|||units on a scale||Standard Deviation|Mean
2696865|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
2696866|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
2696867|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
2696868|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
2696869|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|Score recorded at the end of run-in and open label month||||score on a scale||95% Confidence Interval|Mean
2696870|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|recorded at the end of run-in month and blinded month||||score on a scale||95% Confidence Interval|Mean
2696871|NCT01265797|Secondary|Somatic Symptom Score (Patient Health Questionnaire-15)|"Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms."|28 day period in run-in month and open label month||||score on a scale||95% Confidence Interval|Mean
2696872|NCT01265797|Secondary|Somatic Symptom Severity (Patient Health Questionnaire 15)|"Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms"|28 days recall; measured at end of run-in month and blinded month||||score on a scale||95% Confidence Interval|Mean
2696873|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 day recall, recorded at the end of run-in and open label months||||score on a scale||95% Confidence Interval|Mean
2696874|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 days recall; measured at end of run-in month and blinded month||||score on a scale||95% Confidence Interval|Mean
2696875|NCT01265797|Secondary|Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)|Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|28 day period in run-in month and open label month||||score on a scale||95% Confidence Interval|Mean
2696876|NCT01265797|Secondary|Headache Impact Test-6|Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|after run-in month, after blinded month||||score on a scale||95% Confidence Interval|Mean
2696877|NCT01265797|Primary|Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)|Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 days recall; measured at end of run-in month and blinded month|The number of participants included the individuals who have completed the run-in period and the blinded period. The data was analyzed 'per protocol' based on the number of participants completing the blinded period.|||depression score/14 day recall||95% Confidence Interval|Mean
2696878|NCT01265797|Secondary|Depression Score (Patient Health Questionnaire-9)|Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 day recall, recorded at the end of run-in and open label months||||score on a scale||95% Confidence Interval|Mean
2696879|NCT01265797|Secondary|Headache Days|Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period in run-in month and open label month||||headache days/ 28 day period||95% Confidence Interval|Mean
2696880|NCT01265797|Primary|Mean Headache Days|Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period during run-in month and blinded month||||headache days/ 28 day period||95% Confidence Interval|Mean
2696881|NCT01265784|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable AUC(0-12) data.|||nanogram*hours per milliliter (ng*h/mL)||Standard Deviation|Mean
2696882|NCT01265784|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2696883|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
2696884|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
2696885|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
2696886|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit|Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).|EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
2696959|NCT01265550|Secondary|Number of Enrolled Participants With Irritable Bowel Syndrome||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for irritable bowel syndrome|||Participants|||Count of Participants
2696887|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
2696888|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
2696889|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.|||participants|||Number
2696890|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.|||participants|||Number
2696891|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.|||participants|||Number
2696892|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit||Follow-Up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
2696893|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
2696894|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
2696895|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.|||participants|||Number
2696896|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.|||participants|||Number
2696897|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of intra-abdominal infection (IAI). The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.|||participants|||Number
2696898|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2696899|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2696900|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2696901|NCT01265784|Primary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure [TOC] assessment was not available, death unrelated to cIAI, or some other reason).|TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
2696902|NCT01265719|Secondary|Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline|"Fundoscopy was performed after dilation of the pupils (eg, 1 % tropicamide or cyclopentolate and 2 ½ % phenylephrine, or a clinically- appropriate dose according to the clinician's standard care of each particular patient). The examination included an evaluation of the vitreous body, retina (including the macula), and optic nerve head.~The fundoscopy e-CRF was completed only at baseline because the investigators were required to perform slit lamp, direct or indirect ophthalmoscopy at each visit and report any AEs observed which included the vitreous, retina and optic nerve."|Evaluated at Baseline|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696903|NCT01265719|Secondary|Number of Participants With a Change in Anterior Segment Biomicroscopy|Slit-lamp biomicroscopy (mounted or hand-held) without fluorescein and without dilation of the pupil was performed. When slit-lamp examination was not possible, a fixation light and 20-diopter lens (for magnification) was used. At each scheduled visit, deposition of pigment on the corneal endothelial layer or the lens capsule or any abnormalities of the lids, conjunctivae, cornea, anterior chamber, iris, or lens was examined.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696904|NCT01265719|Secondary|Conjunctival/Ocular Hyperemia|"Conjunctiva hyperemia was assessed by slit-lamp examination. When slit-lamp examination is not possible due to subject cooperation, a fixation light and 20-diopter lens (for magnification) was used to assess this parameter. Conjunctival hyperemia was assessed and graded by ophthalmologist at baseline and follow-up visits from grades 0-3 and is as follows:~0 = None, Normal: few vessels of palpebral or bulbar conjunctiva easily observed~= Mild, Reddening of the palpebral or bulbar conjunctiva~= Moderate, Bright reddening of the palpebral or bulbar conjunctiva~= Severe, Deep, bright, and diffuse reddening of the palpebral or bulbar conjunctiva"|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696905|NCT01265719|Secondary|Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)|Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Micrometer||Standard Error|Least Squares Mean
2696906|NCT01265719|Secondary|Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)|The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||mm||Standard Error|Least Squares Mean
2696907|NCT01265719|Secondary|Eyelash Darkening/Thickening|Changes from baseline in eyelash darkening/thickening/lengthening were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696908|NCT01265719|Secondary|Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid|Changes from baseline in localized pigmentation (nevi and freckles) of the conjunctiva, iris and choroid were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696909|NCT01265719|Secondary|Iris Color Darkening|Changes from baseline in iris color were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696910|NCT01265719|Secondary|Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.|A visual field examination was performed for those patients who can cooperate automated perimetry utilizing a threshold program. All visual fields was conducted utilizing the standard white background with a Goldmann size III white stimulus. For those patients who can not perform formal visual field testing, then field to confrontation test was used for younger, non-verbal children, central, steady and maintains fixation was used.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696911|NCT01265719|Secondary|Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios|The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696912|NCT01265719|Secondary|Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)|IOP was preferably measured using 1 of 3 applanation-contact methods: Goldmann applanation tonometry, Perkins tonometry, or TonoPen® (tonometry). iCare® rebound tonometer was also allowed if it was used consistently throughout the study.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||mmHg||Standard Error|Least Squares Mean
2696913|NCT01265719|Secondary|Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)|The horizontal corneal diameter was measured along the horizontal meridians. Diameter was measured using either a series of transparent plates with holes of different diameters in quarter-millimeter increments or with calibrated calipers compared against a ruler. When using calipers, the corneal diameter measurement was taken from limbus to a similar point 180° away at the opposite limbus. When not examining the children with anesthesia, it was recommended to use a tape measure across the head while measuring horizontal corneal diameter by photographic method.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||mm||Standard Error|Least Squares Mean
2696914|NCT01265719|Secondary|Number of Participants With Clinically Meaningful Change in Refractive Error|The refractive error [cycloplegic where appropriate (eg, those unable to cooperate with manifest refraction)] were determined at the baseline visit and assessed at the following visits.|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||Participants|||Number
2696915|NCT01265719|Primary|Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)|Patients familiar with the letters of the alphabet were evaluated using Snellen visual acuity. Patients who were unable or unfamiliar with the letters of the alphabet were evaluated using charts made up of numbers, pictures (eg, Schering's Children's Eye Chart or Allen Cards), E's, or Landolt's broken rings, and other methods which were equivalent to Snellen acuity eg, HOTV testing).|Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months|The Full Analysis population included all enrolled subjects.|||logMar||Standard Error|Least Squares Mean
2696916|NCT01265667|Secondary|Nature and Frequency of Adverse Events|Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data|32 weeks||||Participants|||Count of Participants
2696917|NCT01265667|Secondary|Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75|Achievement of PASI 50 or 75 indicates a 50% and 75% reduction respectively in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)|16 weeks|Analysis performed of the ITT population|||participants|||Number
2696918|NCT01265667|Secondary|Number of Subjects Achieving PGA of 0 or 1|PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe)|16 weeks|Analysis was performed on the ITT population|||participants|||Number
2696919|NCT01265667|Primary|Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks|Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)|12 weeks|Analysis was performed on the Intent-to-treat (ITT) Population|||Participants|||Count of Participants
2696920|NCT01265615|Secondary|Coronary Calcium Score|Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) of the whole body, lumbar spine and hip was performed using Hologic scanners (QDR 1000W or QDR 2000). The total Agatston coronary calcium score (CCS) was measured as the sum of calcified plaque scores of all the coronary arteries. The amount of calcium present in the coronary arteries is scored according to the Agatson scale, as follows: 0 - no identifiable disease; 1 to 99 - mild disease; 100 to 399 - moderate disease; 400 or higher - severe disease.|on day 180||||units on a scale||Standard Deviation|Mean
2696921|NCT01265615|Secondary|Systolic Blood Pressure|SBP measured by routine method|on day 180||||mmHg||Standard Deviation|Mean
2696922|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Kidney|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180||||fmol VDR/ mg protein||Standard Deviation|Mean
2696923|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Myocardium|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180||||fmol VDR/ mg protein||Standard Deviation|Mean
2696924|NCT01265615|Secondary|Number of Circulating SP (Side Population) Stem-Progenitor Cells|Renal cells and solid tissue were obtained from the normal portion of cortex obtained from surgically removed kidneys or by standart biopsy on day 180. Cytofluorimetric analysis and immunofluorescence were performed as described by Oliver J.A. (2004). Sorting and analysis of different cells was done on a FACS (fluorescent activated cell sorting) and by flow cytometry. Cells were analyzed with EPICS systems (Beckman Coulter). Quantification of mRNA expression was achieved using Assays-on-Demand gene expression kits and the ABI PRISM 7000 Sequence Detection System (Applied Biosystem).|on day 180||||per cent of SP cells||Standard Deviation|Mean
2696925|NCT01265615|Secondary|Serum Creatinine|After an overnight fast, plasma concentrations of hemoglobin, creatinine, cholesterol, glucose, total calcium, and phosphate were measured using an autoanalyzer as described by Adorini L. (2005)|on day 180 after Tx||||mg/dL||Standard Deviation|Mean
2696926|NCT01265615|Secondary|CAD (Chronic Allograft Dysfunction) Degree|"CAD degree measured by Banff score after routine renal biopsy (revised 2005/2007 criteria). We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26-50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|on day 90||||Scores on a Banff scale||Standard Deviation|Mean
2696927|NCT01265615|Secondary|GFR (Glomerular Filtration Rate)|Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated form of the Modification of Diet in Renal Disease (MDRD) study equation: eGFR = exp (5.228 − 1.154 × ln (serum creatinine) − 0.203 × ln (age). Concerning of GFR with Tc99m DTPA renography was used for the complex analysis of renal function. Camera based GFR estimated from Tc99m DTPA renography was named Gates GFR.|on day 180||||ml/min/1.73 m^2||Standard Deviation|Mean
2696928|NCT01265615|Secondary|Heart Failure (HF)|"NYHA (New York Heart Association) functional class verified with veloergometry probe and by NYHA clinical classification NYHA Class Symptoms I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.~II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).~Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|on day 180 after Tx (transplantation)|A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 40 nmol/l) were assigned. Analysis was per protocol.|||NYHA functional class of HF||Standard Deviation|Mean
2696929|NCT01265615|Primary|CAD (Chronic Allograft Dysfunction) Degree|"Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26-50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|day 180 after Tx (transplantation)||||Scores on a Banff scale||Standard Deviation|Mean
2696960|NCT01265550|Secondary|Number of Enrolled Participants With Cyclic Vomiting Syndrome||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for cyclic vomiting syndrome|||Participants|||Count of Participants
2696930|NCT01265563|Secondary|Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines|Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analyzed.|Baseline and 3 months|The secondary outcome measures: Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines could not be measured due to lack of research personnel support and change in the PI who didn't have sufficient expertise to assess these measures.||||||
2696931|NCT01265563|Secondary|Change From Baseline in Hemoglobin-A1c|Hemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods|Baseline and 3 months||||percentage||Standard Deviation|Mean
2696932|NCT01265563|Primary|Change From Baseline in Urinary Albumin Excretion|Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.|Baseline and 3 months||||mg/g||Standard Deviation|Mean
2696933|NCT01265550|Secondary|Number of Successful Surgery Participants With Fundoplication Floppiness Demonstrated by Passing a Grasper Between Fundoplication and Dilator-filled Esophagus Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696934|NCT01265550|Secondary|Number of Successful Surgery Participants With Fundoplication Secured to Esophagus With at Least Two Sutures Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696935|NCT01265550|Secondary|Number of Successful Surgery Participants With Fundoplication Placed Above the Epiphrenic Fat Pad, Using 3 Sutures Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696936|NCT01265550|Secondary|Number of Successful Surgery Participants With Fundoplication Between 1.5 and 2.5cm in Length Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696937|NCT01265550|Secondary|Number of Successful Surgery Participants With Passage of an Esophageal Dilator of at Least 56 French Diameter Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696938|NCT01265550|Secondary|Number of Successful Surgery Participants With Closure of the Crura With Non-absorbable Suture to be Snug With a Dilator of at Least 56 French Diameter Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696939|NCT01265550|Secondary|Number of Successful Surgery Participants With Complete Mobilization of the Fundus, to Include All Short Gastric and Posterior Gastric Vessels to the Base of the Left Crus Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696940|NCT01265550|Secondary|Number of Successful Surgery Participants With Dissection of Distal Esophagus to Obtain at Least 2.5cm of Tension-free, Intra-abdominal Esophagus Performed.||12 months|Surgical participants with at least 50% improvement in the baseline GERD-HRQL score at 12 months.|||Participants|||Count of Participants
2696941|NCT01265550|Secondary|Number of Successful Participants With Functional Gallbladder Disorder|Presence of functional gallbladder disorder as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes|||Participants|||Count of Participants
2696942|NCT01265550|Secondary|Number of Successful Participants With Unspecified Functional Bowel Disorder|Presence of unspecified functional bowel disorder as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696943|NCT01265550|Secondary|Number of Successful Participants With Functional Diarrhea|Presence of functional diarrhea as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes|||Participants|||Count of Participants
2696944|NCT01265550|Secondary|Number of Successful Participants With Functional Bloating|Presence of functional bloating as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696945|NCT01265550|Secondary|Number of Successful Participants With Irritable Bowel Syndrome|Presence of irritable bowel syndrome as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes|||Participants|||Count of Participants
2696946|NCT01265550|Secondary|Number of Successful Participants With Cyclic Vomiting Syndrome|Presence of cyclic vomiting syndrome as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696947|NCT01265550|Secondary|Number of Successful Participants With Functional Vomiting|Presence of functional vomiting as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696948|NCT01265550|Secondary|Number of Successful Participants With Chronic Idiopathic Nausea|Presence of chronic idiopathic nausea as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696949|NCT01265550|Secondary|Number of Successful Participants With Belching Disorders|Presence of belching disorders as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696950|NCT01265550|Secondary|Number of Successful Participants With Globus|Presence of globus as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696951|NCT01265550|Secondary|Number of Successful Participants With Functional Dysphagia|Presence of functional dysphagia as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696952|NCT01265550|Secondary|Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin|Presence of functional chest pain of presumed esophageal origin as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696953|NCT01265550|Secondary|Number of Successful Participants With Functional Heartburn|Presence of functional heartburn as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
2696966|NCT01265550|Secondary|Number of Enrolled Participants With Functional Chest Pain of Presumed Esophageal Origin||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional chest pain of presumed esophageal origin|||Participants|||Count of Participants
2696967|NCT01265550|Secondary|Number of Enrolled Participants With Functional Heartburn||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for functional heartburn|||Participants|||Count of Participants
2696968|NCT01265550|Secondary|Number of Enrolled Participants With Anxiety and/or Depression||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for anxiety and/or depression|||Participants|||Count of Participants
2696969|NCT01265550|Secondary|Number of Enrolled Participants With Weak Peristalsis II||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis II|||Participants|||Count of Participants
2696970|NCT01265550|Secondary|Number of Enrolled Participants With Weak Peristalsis I||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for weak peristalsis I|||Participants|||Count of Participants
2696971|NCT01265550|Secondary|Number of Enrolled Participants With Jackhammer Esophagus||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for jackhammer esophagus|||Participants|||Count of Participants
2696972|NCT01265550|Secondary|Number of Enrolled Participants With Hypertensive Peristalsis||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for hypertensive peristalsis|||Participants|||Count of Participants
2696973|NCT01265550|Secondary|Number of Enrolled Participants With Rapid Contraction||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for rapid contraction|||Participants|||Count of Participants
2696974|NCT01265550|Secondary|Number of Enrolled Participants With Ineffective Esophageal Motility||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for ineffective esophageal motility|||Participants|||Count of Participants
2696975|NCT01265550|Secondary|Number of Enrolled Participants With Nutcracker Esophagus||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for nutcracker esophagus|||Participants|||Count of Participants
2696976|NCT01265550|Secondary|Number of Enrolled Participants With Distal Esophageal Spasm||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for distal esophageal spasm|||Participants|||Count of Participants
2696977|NCT01265550|Secondary|Number of Enrolled Participants With Aperistalsis||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for aperistalsis|||Participants|||Count of Participants
2696978|NCT01265550|Secondary|Number of Enrolled Participants With Achalasia||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for achalasia|||Participants|||Count of Participants
2696979|NCT01265550|Secondary|Number of Enrolled Participants With Gastric Outlet Obstruction||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for gastric outlet obstruction|||Participants|||Count of Participants
2696980|NCT01265550|Secondary|Number of Enrolled Participants With Candida Esophagitis.||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for candida esophagitis|||Participants|||Count of Participants
2696981|NCT01265550|Secondary|Number of Enrolled Participants With Neoplasm of the Esophagus, Stomach or Duodenum||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for neoplasm of the esophagus, stomach or duodenum|||Participants|||Count of Participants
2696982|NCT01265550|Secondary|Number of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum.||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for active ulcerations of the stomach and/or duodenum|||Participants|||Count of Participants
2696983|NCT01265550|Secondary|Number of Enrolled Participants With Eosinophilic Esophagitis||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for eosinophilic esophagitis|||Participants|||Count of Participants
2696984|NCT01265550|Secondary|Number of Enrolled Participants With Reflux Esophagus.||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for reflux esophagus.|||Participants|||Count of Participants
2696985|NCT01265550|Secondary|Number of Enrolled Participants With Esophageal Ulceration.||Screening|The Overall number of participants analyzed represents those Enrolled Participants who were evaluated for esophageal ulceration.|||Participants|||Count of Participants
2696986|NCT01265550|Primary|Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months|"Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months.~Failure; <50% improvement in the baseline GERD-HRQL score at 12 months or:~For patients randomized to Surgical Treatment: a.<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit.~For patients randomized to Active Medical or Placebo Medical Treatment:~a.inability to tolerate both study medications or b.For patients treated with desipramine, i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit."|12 months||||Participants|||Count of Participants
2696987|NCT01265537|Secondary|eGFR at 6 Months|Participant eGFR value by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||mL/min/1.73^2||Inter-Quartile Range|Median
2713718|NCT01147471|Other Pre-specified|Still on Narcotics at Post-discharge Follow-up|Number of people still on narcotics at time of routine care post-discharge follow-up|approx 2 weeks post discharge||||participants|||Number
2696988|NCT01265537|Secondary|Change From Baseline in Weight|Any changes in weight by end of study.|baseline to 6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||kg||Inter-Quartile Range|Median
2696989|NCT01265537|Secondary|Number of Leukopenia Events on ≥2 Occasions|Any leukopenia on ≥2 occasions by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||events|||Number
2696990|NCT01265537|Secondary|Number of Any Leukopenia Events|Any leukopenia by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||events|||Number
2696991|NCT01265537|Secondary|Number of Participants With Cardiovascular Event|Any cardiovascular events by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696992|NCT01265537|Secondary|Number of Participants With Malignancy Events|Any malignancy (including post-transplant lymphoproliferative disease) by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696993|NCT01265537|Secondary|Number of Participants With Hospitalization Events|Any hospitalization by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696994|NCT01265537|Secondary|Number of Participants With Infection Events|Any infection (CMV, opportunistic infections including urinary tract infections requiring treatment, pneumonia) by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696995|NCT01265537|Secondary|Number of Participants With Dialysis Events|Any dialysis required by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696996|NCT01265537|Secondary|Number of Participants With Graft Failure|Any graft failure by the end of the study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696997|NCT01265537|Secondary|Number of Participant Deaths|Death of any participant by end of study.|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696998|NCT01265537|Primary|Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection|Composite endpoint of biopsy proven acute rejection and NODAT at 6 months post transplantation. NODAT will be defined as either FPG >7.0mmol/L OR symptoms of hyperglycemia and a random plasma glucose of >11.1 OR 2-h plasma glucose >11.1 during an oral glucose tolerance test(OGTT).|6 months post transplant|The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.|||Participants|||Count of Participants
2696999|NCT01265524|Secondary|6MWT Distance at Week 8|Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||m||Standard Deviation|Mean
2697000|NCT01265524|Secondary|Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8||Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||participants|||Number
2697001|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.|8 weeks||||participants|||Number
2697002|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.|4 weeks||||participants|||Number
2697003|NCT01265524|Secondary|Weight Loss at Week 2||Baseline and 2 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||kg||Standard Deviation|Mean
2697004|NCT01265524|Secondary|Weight Loss at Week 1||Baseline and 1 week|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||kg||Standard Deviation|Mean
2697024|NCT01265498|Secondary|Change in Total Protein||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||gl/L||Standard Deviation|Mean
2697005|NCT01265524|Primary|Change in Serum Potassium|Change in serum potassium from baseline to Week 8.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||mg/dl||Standard Deviation|Mean
2697006|NCT01265511|Secondary|Undetectable HCV RNA||Week 24|Week 24 analysis does not include the 2 placebo subjects because they were discontinued for lack of efficacy before week 24.|||participants|||Number
2697007|NCT01265511|Secondary|Partial Early Virologic Response|Proportion of subjects with detectable HCV RNA that achieve a > or = 2 log reduction in HCV RNA from baseline to Week 12|Week 12||||participants|||Number
2697008|NCT01265511|Secondary|Undetectable HCV RNA||Week 12||||participants|||Number
2697009|NCT01265511|Primary|Undetectable HCV RNA||Week 4||||participants|||Number
2697010|NCT01265498|Secondary|Change in SF-36 Quality of Life Mental Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||units on a scale||Standard Deviation|Mean
2697011|NCT01265498|Secondary|Change in SF-36 Quality of Life Physical Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||units on a scale||Standard Deviation|Mean
2697012|NCT01265498|Secondary|Change in Diastolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mm Hg||Standard Deviation|Mean
2697013|NCT01265498|Secondary|Change in Systolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mm Hg||Standard Deviation|Mean
2697014|NCT01265498|Secondary|Change in Waist-to-hip Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||ratio||Standard Deviation|Mean
2697015|NCT01265498|Secondary|Change in Waist Circumference||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||cm||Standard Deviation|Mean
2697016|NCT01265498|Secondary|Change in Body-mass Index||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||kg/m²||Standard Deviation|Mean
2697017|NCT01265498|Secondary|Change in Weight||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||kg||Standard Deviation|Mean
2697018|NCT01265498|Secondary|Change in Glycated Haemoglobin A1c||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/mol||Standard Deviation|Mean
2697019|NCT01265498|Secondary|Change in HOMA-IR||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||glucose[mmol/L]× insulin[pmol/L] / 22.5||Standard Deviation|Mean
2697020|NCT01265498|Secondary|Change in Insulin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||pmol/L||Standard Deviation|Mean
2697021|NCT01265498|Secondary|Change in Fasting Serum Glucose||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697022|NCT01265498|Secondary|Change in International Normalised Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||ratio||Standard Deviation|Mean
2697023|NCT01265498|Secondary|Change in Prothrombin Time||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||s||Standard Deviation|Mean
2697085|NCT01264887|Primary|Time Dependence of Adverse Events|The onset and duration of TEAEs was not evaluated for this trial.|Day 1; 144 weeks|No evaluation was performed.||||||
2697025|NCT01265498|Secondary|Change in Albumin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||gl/L||Standard Deviation|Mean
2697026|NCT01265498|Secondary|Change in Uric Acid||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||μmol/L||Standard Deviation|Mean
2697027|NCT01265498|Secondary|Change in Creatinine||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||μmol/L||Standard Deviation|Mean
2697028|NCT01265498|Secondary|Change in Phosphate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697029|NCT01265498|Secondary|Change in Calcium||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697030|NCT01265498|Secondary|Change in Bicarbonate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697031|NCT01265498|Secondary|Change in Platelet Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||platelets *10^9 per L||Standard Deviation|Mean
2697032|NCT01265498|Secondary|Change in White Blood Cell Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||white blood cells *10^9 per L||Standard Deviation|Mean
2697033|NCT01265498|Secondary|Change in Mean Corpuscular Volume||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||fL||Standard Deviation|Mean
2697034|NCT01265498|Secondary|Change in Haematocrit||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||proportion of 1.0||Standard Deviation|Mean
2697035|NCT01265498|Secondary|Change in Haemoglobin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||g/L||Standard Deviation|Mean
2697036|NCT01265498|Secondary|Change in Triglycerides||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697037|NCT01265498|Secondary|Change in LDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697038|NCT01265498|Secondary|Change in HDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697039|NCT01265498|Secondary|Change in Total Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
2697040|NCT01265498|Secondary|Change in Total Bilirubin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||μmol/L||Standard Deviation|Mean
2697041|NCT01265498|Secondary|Change in γ-glutamyl Transpeptidase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
2697042|NCT01265498|Secondary|Change in Alkaline Phosphatase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
2697043|NCT01265498|Secondary|Change in Asparate Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
2697044|NCT01265498|Secondary|Change in Alanine Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
2697045|NCT01265498|Secondary|Portal Inflammation: Change in Score|Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
2697046|NCT01265498|Secondary|Portal Inflammation: Patients With Improvement|Patients with improvement in portal inflammation score. Portal inflammation was assessed on a scale of 0-2, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
2697047|NCT01265498|Secondary|Lobular Inflammation: Change in Score|Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
2697048|NCT01265498|Secondary|Lobular Inflammation: Patients With Improvement|Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
2697049|NCT01265498|Secondary|Steatosis: Change in Score|Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
2697050|NCT01265498|Secondary|Steatosis: Patients With Improvement|Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
2697051|NCT01265498|Secondary|Hepatocellular Ballooning: Change in Score|Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
2697052|NCT01265498|Secondary|Hepatocellular Ballooning: Patients With Improvement|Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
2697053|NCT01265498|Secondary|Total NAFLD Activity Score: Change in Score|NAFLD activity score was assessed on a scale of 0-8, with higher scores showing more severe disease (the components of this measure are steatosis [assessed on a scale of 0-3], lobular inflammation [assessed on a scale of 0-3], and hepatocellular ballooning [assessed on a scale of 0-2]).|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
2697054|NCT01265498|Secondary|Fibrosis: Change in Score|Change in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis.|baseline to 72 weeks||||units on a scale||Standard Deviation|Mean
2697055|NCT01265498|Secondary|Fibrosis: Patient With Improvement|Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
2697056|NCT01265498|Secondary|Resolution of NASH Diagnosis|Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
2697057|NCT01265498|Primary|Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|"Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:~No worsening in fibrosis; and~A decrease in NAFLD Activity Score (NAS) of at least 2 points"|baseline to 72 weeks|Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement.|||participants|||Number
2697058|NCT01265459|Secondary|Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)|"The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from very poor=0 to excellent=10."|26 weeks after treatment compared to baseline||||units on a scale||Standard Deviation|Mean
2697059|NCT01265459|Secondary|WOMAC Physical Function Score (Change From Baseline)|"The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline||||units on a scale||Standard Deviation|Mean
2697060|NCT01265459|Secondary|WOMAC Stiffness Score (Change From Baseline)|"The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline||||units on a scale||Standard Deviation|Mean
2697061|NCT01265459|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.|"Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, Since your last clinical visit have you had any health problems?."|From baseline to 26 weeks after treatment||||participants|||Number
2697062|NCT01265459|Primary|Change of Pain Over 26 Weeks (Change From Baseline)|"The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|"The primary population for all efficacy evaluations was the ITT population (all subjects randomized and treated with study product).~No imputation of missing data was done. Analyses presented were based on observed cases."|||units on a scale||Standard Deviation|Mean
2697063|NCT01265446|Secondary|Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.|Baseline and 240 mn post-dose|intent to treat|||mm||95% Confidence Interval|Mean
2697064|NCT01265446|Primary|Change From Baseline Sore Throat Pain Intensity|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)|Baseline and 2 hours post-dose|Intent to treat|||mm||95% Confidence Interval|Mean
2697065|NCT01265420|Primary|Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)||30 days after last injection||||participants|||Number
2697066|NCT01265394|Secondary|Measurement of Amyloid Content in Different Parts of the Brain|"Is the computerized measurement of amyloid content in different parts of the brain.~The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.~The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.~The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements."|PET scans performed on patients 90 minutes post Flutemetmol Administration|The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.|||Standard Uptake Value Ratio ( SUVR)||Standard Deviation|Mean
2697067|NCT01265394|Primary|Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid|"The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.~The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading)."|PET scans performed on patients 90 minutes post Flutemetmol Administration|Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative|||Brain Scans Read|||Number
2697068|NCT01265056|Secondary|Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)|The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function.|First Clinic Follow Up After Discharge||||units on a scale||Standard Deviation|Mean
2697069|NCT01265056|Secondary|Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups|The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse.|First Clinic Follow Up After Discharge||||units on a scale||Standard Deviation|Mean
2697070|NCT01265056|Primary|Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)||From time of enrollment to 2 weeks after being discharged|This was an intention to treate analysis. We measured the oral morphine equivalents both groups were administered.|||morphine equivalents||Standard Deviation|Mean
2697071|NCT01264952|Primary|Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)||After operation on day 7||||Toxicity, symptoms|||Number
2697072|NCT01264952|Secondary|Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology||After operation or 1st day after operation, 7th day, 30th day, monthly||||complete response (CR)|Participants||Number
2697073|NCT01264952|Secondary|Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment)||After operation on tha days 2, 7, 30, monthly||||patients with non-severe adverse events|||Number
2697074|NCT01264939|Primary|Percentage of Participants With Adverse Events|The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.|Baseline to the end of study (up to 40 weeks)|Safety population: All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2697075|NCT01264939|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12. The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
2697086|NCT01264887|Secondary|Tapentadol Prolonged Release Exposure|The number of days that participants took tapentadol prolonged release. The extent of exposure was categorized into 2 periods, less than 90 days and more than 90 days (up to 144 weeks).|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
2697076|NCT01264939|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|"The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded No to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit."|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.|||Percentage of days||Standard Deviation|Mean
2697077|NCT01264939|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug and who had a DLQI score at Week 12.|||Units on a scale||Standard Deviation|Mean
2697078|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2697079|NCT01264939|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
2697080|NCT01264939|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
2697081|NCT01264939|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Only patients with a MID response were included in the analysis.|||Weeks||95% Confidence Interval|Median
2697082|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2697083|NCT01264939|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2697084|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
2697087|NCT01264887|Other Pre-specified|Average Daily Total Tapentadol Prolonged Release Dose|The Total Daily Dose (TDD) on any given day is the sum of the morning and evening intake amounts. The average TDD is an individuals average over the trial period.|Day 1; up to 144 weeks|Safety Set.|||mg per day||Standard Deviation|Mean
2697088|NCT01264887|Other Pre-specified|Average Pain Intensity (Over a Twelve-week Period)|"The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.~Average pain intensity score is the average of pain experienced for previous 24 hours as rated on an 11-point NRS at each visit. Calculations are based on 3 consecutive planned (at 4-weekly intervals) visits.~All available data of a participant was used; if a participant dropped-out or had incomplete data during a 12-week period no imputations were performed for the missing values."|Day 1; up to Week 144|Safety Set.|||units on a scale||Standard Deviation|Mean
2697089|NCT01264887|Primary|Countermeasures Taken Due to Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
2697090|NCT01264887|Primary|Relatedness Assessment of Treatment Emergent Adverse Events|"Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included possible, probable/likely, and certain; whilst unrelated treatment emergent adverse events include those rated by the investigator as unlikely, conditional/unclassified, un-assessable/unclassifiable, and not related."|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
2697091|NCT01264887|Secondary|Assess Consumption of Tapentadol During Long Term Use|Summary of the modal total daily dose during the treatment period. The modal dose was based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.|Day 1; up to 144 weeks|"The modal dose is based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.~No participant received more than 500 mg per day."|||participants|||Number
2697092|NCT01264887|Primary|Severity of Adverse Events|"The severity of treatment emergent adverse events was any untoward medical occurrence in a patient administered tapentadol. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the (investigational) medicinal product whether or not related to the use of tapentadol.~The clinical intensity of adverse event were classified as:~Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted.~Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration.~Severe: symptoms affected the usual daily activity."|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
2697093|NCT01264835|Primary|Procedure Duration (Surgery Time)|Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.|Time of surgery|No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.|||minutes||Standard Deviation|Mean
2697094|NCT01264770|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
2697095|NCT01264770|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
2697140|NCT01263938|Primary|Change From Baseline in Levels of Plasma Inflammatory Marker MCP-1 of Chronic HIV+/ HAART+ Subjects.|Monocyte specific inflammatory soluble factor MCP-1 was measured by ELISA in plasma of HIV+/HAART+ subjects at baseline and at 12 weeks following atorvastatin treatment.|Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)|Plasma MCP-1 levels|||pg/ml (Change from T0 to T12)||Standard Deviation|Mean
2697096|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
2697097|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Units on a scale||Standard Deviation|Mean
2697098|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Percentage improvement from baseline||Standard Deviation|Mean
2697099|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 6|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Percentage improvement from baseline||Standard Deviation|Mean
2697100|NCT01264770|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
2697101|NCT01264770|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
2697161|NCT01263717|Secondary|Hemostatic Markers|Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.|6 months|Please note that we do not have data for these markers (neither PAI1 or tPA) because we did not have adequate funds to assess these.||||||
2697162|NCT01263717|Secondary|Adiponectin|adiponectin.|6 months|All available data were used. Data were not available for 1 subject.|||Change in ng/mL||Inter-Quartile Range|Median
2697102|NCT01264770|Secondary|Proportion of Patients Achieving ACR20 up to Week 24|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
2697103|NCT01264770|Secondary|DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
2697104|NCT01264770|Secondary|DAS28 EULAR Response at Week 6|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Percentage of responders|||Number
2697105|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
2697106|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Units on a scale||Standard Deviation|Mean
2697107|NCT01264718|Secondary|Intervention Cost-Effectiveness Ratio (ICER)|The difference in total costs between the intervention group and controls|One year after enrollment|237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)|||Dollars|||Number
2697108|NCT01264718|Secondary|Parental Satisfaction With the Process of Obtaining Coverage for Child|Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions|One year after enrollment|121 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, 9 withdrew prior to one-year follow-up, 2 did not answer); and 113 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, 15 withdrew prior to one-year follow-up, and 1 did not answer).|||Participants|||Count of Participants
2697109|NCT01264718|Secondary|Number of Days From Study Enrollment to Obtaining Coverage|Zero time (the point at which the maneuver is imposed) is the data and time of study enrollment. Occurrence of the main outcome event is the date and time of official notification that the child is insured.|One year after enrollment|237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)|||Days||Inter-Quartile Range|Median
2697110|NCT01264718|Primary|Number of Children With Health Insurance|A study child is considered insured once official written notification of insurance is confirmed, either through an electronic or hard copy of the state coverage letter, or via verification from the Texas Health and Human Services Center.|One year after enrollment|237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)|||Participants|||Count of Participants
2697111|NCT01264679|Secondary|Mean Change In TSAT From Baseline To Week 5 And To Week 7|Mean changes in TSAT following the first course of ferumoxytol from Baseline to Week 5 and to Week 7 were to be presented. However, despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5 and Week 7|ITT Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2697112|NCT01264679|Secondary|Proportion Of Participants With An Increase In Hemoglobin From Baseline To Week 5 And To Week 7|The proportion of participants with an increase hemoglobin to ≥1.0 g/dL or to ≥12.0 g/dL during the period from Baseline to Week 5 and to Week 7 following each course of ferumoxytol was to be presented. However, despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5 and Week 7|ITT Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2697113|NCT01264679|Primary|Mean Change In Hemoglobin From Baseline To Week 5|Mean changes in hemoglobin following the first course of ferumoxytol from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5|ITT Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2697114|NCT01264614|Primary|Neurophysiological Function Pre- & Post- Intervention|Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention|Baseline and 3 months|||||||
2697115|NCT01264614|Primary|Figure Copy & Delayed Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Points||Standard Deviation|Mean
2697116|NCT01264614|Primary|Fuld Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Points||Standard Deviation|Mean
2697117|NCT01264614|Primary|Color Trails Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Time to complete (seconds)||Standard Deviation|Mean
2697118|NCT01264614|Primary|Digits Backwards Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Points||Standard Deviation|Mean
2697119|NCT01264614|Primary|Stroop Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Time to complete (seconds)||Standard Deviation|Mean
2697120|NCT01264601|Secondary|Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered|"Rates of co-morbid allergic disease, size and magnitude of egg skin and ImmunoCAP tests, presence of other food allergy, and tolerance of baked egg will be assessed through a screening questionnaire and chart review, and compared between the groups to assess for any significant differences that may predict TIV tolerance."|6 months|Because no participants had systemic/severe reactivity, there were no participants who were TIV intolerant, and therefore no meaningful analysis of correlation of baseline characteristics to intolerance could be performed. All Baseline Characteristics collected for the original purpose of such correlation are reported in Baseline Characteristics.||||||
2697121|NCT01264601|Primary|Categorical Reactivity to Vaccine as it Was Administered|"After randomization, group 1 will receive a 10%/90% (or 20%/80% for 0.25ml) graded challenge of the age appropriate TIV dose, separated by 30 minutes for observation. Group 2 will receive a first dose consisting of normal saline at a volume equal to 10% of their age appropriate dose, and the second dose will consist of their full age appropriate dose as the 90% equivalent, also separated by 30 minutes of observation. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose. All parties will report any adverse reactions occurring in the next 48 hours after vaccination that were not observed at the time of in office observation."|48 hours||||Participants|||Count of Participants
2697122|NCT01264419|Secondary|Number of Participants Demonstrating Acute Device Success, Procedural Success, and Tolerance to Reverse Flow|"Acute Device Success is calculated by tabulating the number of subjects in whom reverse flow could be established AND who received at least 1 stent; Procedural Success is the freedom from MAEs at 30 days post-procedure, where MAEs are defined in the protocol as A composite rate of death, major stroke, and myocardial infarction (Q wave and non-Q wave); Tolerance to Reverse flow is measured as the absence of any temporary occurrence of procedure related neurological symptoms following the establishment of the cerebral reverse flow circuit that resolves within 20 minutes of flow manipulation. The number of subjects included in Tolerance to Reverse Flow were those subjects for whom reverse flow could be both established and measured."|peri-operative to 30 days post-procedure|Per protocol, all enrolled subjects who had a study device placed in their vasculature and completed the 30-day post-procedure period were included in the final analysis data set|||Participants|||Count of Participants
2697123|NCT01264419|Primary|Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death|Safety will be evaluated as a composite of major stroke, myocardial infarction and death during the 30-day post procedural period.|0 days post-procedure to 30 days post-procedure|Per protocol, all enrolled subjects who had a study device placed in their vasculature and completed the 30-day post-procedure period were included in the final analysis data set.|||Occurences|||Number
2697124|NCT01264380|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until death (Up to Week 124)|Data for OS was not collected as there was a change in planned analysis, not to collect the data.||||||
2697125|NCT01264380|Secondary|Percentage of Participants With Best Objective Response (BOR) as Complete Response (CR) or Partial Response (PR)|BOR was defined as the best objective response assessed by investigator during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation. It is defined as the number of participants whose best objective response was complete response (CR) or partial response (PR) divided by the total number of efficacy evaluable participants. CR: disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) were non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until disease progression or death (Up to Week 124)|Intent-to-treat (ITT) population included participants with measurable disease who received at least 1 dose of vemurafenib. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2697126|NCT01264380|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel) in the Fasted and Fed States|Apparent first-order terminal elimination rate constant (kel), was calculated as the negative slope of the linear regression of the terminal phase in plasma vemurafenib concentration-time profile using specific appropriate time points. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|"PK analysis population. Here number of participants analyzed=participants who were evaluable for this outcome measure."|||1/h||Standard Deviation|Mean
2697127|NCT01264380|Primary|Terminal Elimination Half-Life (t1/2) in the Fasted and Fed States|T1/2 is the time required for the concentration of the drug to reach half of its original value. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2697128|NCT01264380|Primary|Time to Reach Maximal Plasma Concentration (Tmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.|||hour||Full Range|Median
2697129|NCT01264380|Primary|Minimum Observed (Trough) Plasma Concentration (Cmin) in the Fasted and Fed States|Single dose Pre-dose concentration is referred as Cmin here. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Pre-dose on Periods A and B|PK analysis population.|||µg/mL||Standard Deviation|Mean
2697130|NCT01264380|Primary|Maximal Observed Plasma Concentration (Cmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.|||µg/mL||Standard Deviation|Mean
2697163|NCT01263717|Secondary|Glucose Tolerance|Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.|6 months|All available data were used; data were not available for some subjects.|||Change in 2-hour glucose, mg/dL||95% Confidence Interval|Mean
2697131|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Sample With Last Measurable Concentration (AUC[0-last]) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||µg*h/mL||Standard Deviation|Mean
2697132|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0-inf]) in the Fasted and Fed States|Pharmacokinetic (PK) analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 hours (h) post-dose (pd) on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population included participants who received both single doses of vemurafenib in Periods A and B without protocol violation and provided adequate PK assessments to calculate important PK parameters. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||micrograms*hour per milliliter (µg*h/mL)||Standard Deviation|Mean
2697133|NCT01264081|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately, 3 years|Three study participants were affected by the adverse events: 2 - who completed the study and 1 who did not complete cycle 1 due to death of progressive disease. The participant who withdrew from study didn't take Lapatinib and experience any adverse events.|||Participants|||Count of Participants
2697134|NCT01264081|Primary|Count of Participants With a Partial Response (PR) and Complete Response (CR) to Lapatinib Who Have Metastatic Melanoma Harboring ERBB4 Mutations.|The count of participants with a partial response and complete response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.|3 years|Only two participants could be evaluated for response and they had SD (none with a PR or CR). Other participants did not reach the evaluation point (i.e. discontinued Lapatinib)as per study protocol, therefore not evaluable.|||Participants|||Count of Participants
2697135|NCT01264016|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing five tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|Per protocol|||participants|||Number
2697136|NCT01264016|Primary|Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject's hematocrit measurement was missing, so this subject's blood test data was not evaluable. Since study staff tested each subject's venous blood using 2 lots of test strips, 2x93(or 186) test results were possible.|||percentage of venous bg results|Participants||Number
2697137|NCT01264016|Primary|Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject did not complete capillary blood testing (low blood sugar) and one subject hematocrit measurement was missing. These subjects' blood test data was not evaluable. Since the remaining 92 subjects tested 2 test strip lots on the BGM system, 2x92(184) tests results were possible.|||percentage of BG Results|Participants||Number
2697138|NCT01263938|Primary|Change From Baseline in Levels of Plasma Inflammatory Marker sCD163 of Chronic HIV+/ HAART+ Subjects.|Monocyte specific inflammatory soluble factor sCD163 was measured by ELISA in plasma of HIV+/HAART+ subjects at baseline and at 12 weeks following atorvastatin treatment.|Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)|Plasma sCD163 levels|||ng/ml (Change fromT=0 to T=12wk)||Standard Deviation|Mean
2697139|NCT01263938|Primary|Change From Baseline in Levels of Plasma Inflammatory Marker sCD14 of Chronic HIV+/ HAART+ Subjects.|Monocyte specific inflammatory soluble factor sCD14 was measured by ELISA in plasma of HIV+/HAART+ subjects at baseline and at 12 weeks following atorvastatin treatment.|Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)|Plasma sCD14 levels|||ug/ml (Change fromT=0 to T=12wk)||Standard Deviation|Mean
2697141|NCT01263938|Primary|Change in Monocyte Surface Markers Expression (Expressed as Percentage), Following Treatment of Chronic HIV+/ HAART+ Subjects With Atorvastatin (T=12wks Versus T=0wk).|Effects of Atorvastatin on immune activation associated surface markers (CD16, CD163 and CCR2) of monocytes were assessed in chronic HIV+/HAART+ subjects following 12 weeks of treatment. Whole blood drawn from these subjects were stained with fluorochrome tagged antibodies to the surface markers. Stained whole blood cells were then acquired on a flow cytometer and analyzed using the Flowjo software to determine the percentage of cells (monocytes) expressing the specific marker. This was done before starting and after completing drug treatment to assess the effect of drug.|Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)|1) Percentage of peripheral blood monocyte surface markers: CD16, CD163, CCR2|||Change T=0 to T=12 (percentage change)||Standard Deviation|Mean
2697142|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).~Negative changes show a decrease from Baseline."|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2697143|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).~Negative changes show a decrease from Baseline."|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2697144|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697145|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697146|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697147|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697148|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697149|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697150|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697151|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697152|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697153|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697154|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697155|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
2697156|NCT01263873|Primary|Ease of Intubation, as Measured by an Ease of ETT Insertion Score.|To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.|Participants were followed for the duration of intubation, an average of 10 minutes||||Visual Analog Score in millimeters||Standard Deviation|Mean
2697157|NCT01263873|Primary|Ease of Intubation, as Measured by Number of ETT Redirections|To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.|Participants were followed for the duration of intubation, an average of 10 minutes||||Number of redirections to place ETT||Standard Deviation|Mean
2697158|NCT01263873|Primary|Ease of Intubation, as Measured by Time in Seconds for ETT Insertion|To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).|Participants were followed for the duration of intubation, an average of 10 minutes||||Seconds||Standard Deviation|Mean
2697159|NCT01263782|Secondary|Overall Response Rate|Tumor response was assessed every two cycles of completed therapy. Responses will be based on a comparison to the pretreatment tumor evaluation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From treatment start to every two cycles of completed therapy.|Patients who were evaluable for response|||Participants|||Count of Participants
2697160|NCT01263782|Primary|Progression Free Survival|It is defined as from treatment start to the time of progression or death, whichever occurred first, or to the time of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From treatment start to the time of progression or death, whichever occurred first, or to the time of last contact, assessed up to 5 years|Patients who had treatment|||month||95% Confidence Interval|Median
2697168|NCT01263717|Secondary|Insulin Sensitivity|In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.|6 months|All available data were used; data were not available for some subjects.|||Change in mg/kg/min||95% Confidence Interval|Mean
2697169|NCT01263717|Secondary|Endogenous Growth Hormone Secretion|Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.|6 months|All available data were used; data were not available for some subjects.|||Change in ng/mL||Inter-Quartile Range|Median
2697170|NCT01263717|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.|||Change in ratio of IMCL/Cr||Inter-Quartile Range|Median
2697171|NCT01263717|Primary|Visceral Adipose Tissue|Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.|6 months|Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.|||change in cm^2 after 6 months||95% Confidence Interval|Mean
2697172|NCT01263717|Primary|Liver Fat|Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.|||Change in hepatic lipid-to-water %||Inter-Quartile Range|Median
2697173|NCT01263704|Secondary|Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire|The FACIT-F questionnaire consists of 13 questions with a total score range of 0 to 52 with 0 indicating a better outcome and 52 indicating a worse outcome.|[Visit 1 (Screening, Week 0), at Visits 11 (Week 45) and 14 (Week 80) and at the end of the study (Month 42)]|Efficacy analysis population included all participants who received rituximab during the study. Participants from the efficacy analysis population, who completed the FACIT-F questionnaire at any time point during the study, were analyzed as indicated at each time point.|||score on a scale||Standard Deviation|Mean
2697174|NCT01263704|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval from the first study drug treatment day to the first sign of disease progression according to NCI-WG guidelines. Progressive disease (PD): Any new lesion, any disease symptoms, >/=50% increase in lymphadenopathy, splenomegaly, hepatomegaly, >/= 50% increase in the number of circulating clonal B lymphocytes, decrease of hemoglobin levels by > 2.0 g/dL, >/= 50% decrease of platelet counts, increase of lymphocytes in bone marrow to more than 30% from normal.|Up to 53 months|Efficacy analysis population included all participants who received rituximab during the study.|||months||95% Confidence Interval|Median
2697175|NCT01263704|Secondary|Hospitalization Days||Up to 53 months|The safety population included all enrolled participants.|||days||Full Range|Median
2697176|NCT01263704|Secondary|Percentage of Participants With Neutropenic Fever, Infection, >/= Grade 3 Drug-Related Neutropenia, >/= Grade 3 Drug-Related Thrombocytopenia, Hospitalizations||Up to 53 months|The safety population included all enrolled participants.|||percentage of participants|||Number
2697177|NCT01263704|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as adverse events. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution, and fulfills any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|Up to 53 months|The safety population included all enrolled participants.|||percentage of participants|||Number
2697178|NCT01263704|Primary|Overall Response Rate|Overall response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to National Cancer Institute - Working Group [NCI-WG] guidelines. CR: no clonal B lymphocytes in peripheral blood, no significant lymphadenopathy, liver and spleen normal size, no disease symptoms, blood counts: absolute neutrophil count (ANC) >1,500/microliter (mcL), platelets > 100,000/mcL, hemoglobin > 11.0 grams/deciliter (g/dL), normocellular bone marrow. PR: >/= 50% decrease in clonal B lymphocyte count, >/= 50% reduction in lymphadenopathy, >/= 50% reduction of liver or spleen enlargement and ANC >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 11.0 g/dL OR >/= 50% increase in ANC, platelets or hemoglobin.|Up to 42 months|Efficacy analysis population included all participants who received rituximab during the study.|||percentage of participants||95% Confidence Interval|Number
2697179|NCT01263691|Secondary|TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).|||geometric mean titer||95% Confidence Interval|Geometric Mean
2697234|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697180|NCT01263691|Secondary|Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).|||days||Full Range|Median
2697181|NCT01263691|Primary|Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.~Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56||||percentage of participants|||Number
2697182|NCT01263691|Primary|Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.~Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56||||participants|||Number
2697183|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||percentage of participants|||Number
2697184|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||participants|||Number
2697185|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||percentage of participants|||Number
2697186|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||Participants|||Number
2697187|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||Percentage of Participants|||Number
2697188|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||Participants|||Number
2697189|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||Percentage of Participants|||Number
2697190|NCT01263691|Secondary|Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).|||geometric mean titer||95% Confidence Interval|Geometric Mean
2697191|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||Participants|||Number
2697192|NCT01263665|Primary|Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure||30 Days post-procedure||||participants|||Number
2697193|NCT01263665|Primary|Successful Completion of the Assigned Treatment|Successful completion of the assigned treatment and postdeployment > stent length (of the first deployed 25 cm GORE > VIABAHN Endoprosthesis with PROPATEN Bioactive Surface) > being within 10% of pre-deployment stent length.|Evaluated immediately after the index procedure||||percentage of subjects|||Number
2697194|NCT01263639|Primary|"Patient Satisfaction as Measured by Giving an Excellent Score on a 5-point Rating"|Within 2 weeks of discharge from the hospital, but before the patient's first clinic visit, each group will be called by the Professional Resource Group as part of regular quality improvement by the Vanderbilt Medical Center Department of Strategic Development. The patients will be asked a series of questions aimed at determining overall patient satisfaction based on interactions with the attending orthopaedic trauma surgeon.|within 2 weeks of discharge and before first clinic appointment||||participants|||Number
2697195|NCT01263561|Secondary|Complications|Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.|1 year post surgery||||participants|||Number
2697198|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
2697199|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
2697200|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
2697201|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
2697202|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
2697203|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
2697204|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
2697205|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
2697206|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
2697207|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
2697208|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
2697209|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
2697210|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
2697211|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
2697212|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
2697213|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
2697214|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697215|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697216|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697217|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697218|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697219|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697220|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697221|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697222|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697223|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697224|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697225|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697226|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697227|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697228|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697229|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697230|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697231|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697232|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697233|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2715732|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8||56 Days|Participants with available data at Week 8.|||percentage of participants|||Number
2697235|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697236|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697237|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697238|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697239|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697240|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697241|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697242|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697243|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697244|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697245|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697246|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697247|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697248|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697249|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697250|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697251|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697252|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697253|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697288|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697254|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697255|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697256|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697257|NCT01263509|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set|||participants|||Number
2697258|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
2697259|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
2697260|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
2697261|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
2697262|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
2697263|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
2697264|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
2697265|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
2697266|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
2697267|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
2697268|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
2697269|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
2697270|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
2697271|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
2697272|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
2697273|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
2697274|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697275|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697276|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697277|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697278|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697279|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697280|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697281|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697282|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697283|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697284|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697285|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697286|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697287|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697289|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
2697290|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697291|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697292|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697293|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697294|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697295|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697296|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697297|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697298|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697299|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697300|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697301|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
2697302|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697303|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697304|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697305|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697306|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697307|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697308|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697807|NCT01260688|Secondary|Treatment Discontinuation|Discontinuation of treatment in cycle 1 (average of 28 days)|Cycle 1 (average of 28 days)|Analysis was performed on study participants enrolled on the trial assessing number of patients who discontinued treatment in cycle 1.|||Participants|||Count of Participants
2697309|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697310|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697311|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697312|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697313|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697314|NCT01263496|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set|||participants|||Number
2697315|NCT01263483|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.|||pg·hr/mL||Standard Deviation|Mean
2697316|NCT01263483|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||ng·hr/mL||Standard Deviation|Mean
2697317|NCT01263483|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.|||μU·hr/mL||Standard Deviation|Mean
2697318|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg·hr/dL||Standard Deviation|Mean
2697319|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697320|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697321|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697322|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697323|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697324|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697325|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697326|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697327|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697328|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697329|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697330|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697331|NCT01263483|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697332|NCT01263470|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||pg·hr/mL||Standard Deviation|Mean
2697333|NCT01263470|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng·hr/mL||Standard Deviation|Mean
2697334|NCT01263470|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||μU·hr/mL||Standard Deviation|Mean
2697335|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg·hr/dL||Standard Deviation|Mean
2697336|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697337|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697338|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697339|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697340|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
2697341|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697342|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697343|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697344|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2697345|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697346|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697347|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697348|NCT01263470|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2697808|NCT01260688|Secondary|Number Who Experienced Study Medication Dose Intensity|Number of patients who experienced study medication dose of over 80% during Cycle 1 was assessed.|Cycle 1 (an average of 28 days)||||participant|||Number
2697349|NCT01263444|Secondary|Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.|Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||percentage of participants|||Number
2697350|NCT01263444|Secondary|Mean Change From Baseline in IOP at Week 4|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 4|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||mmHg||Standard Deviation|Mean
2697351|NCT01263444|Secondary|Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||mmHg||Standard Deviation|Mean
2697352|NCT01263444|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||mmHg||Standard Deviation|Mean
2697353|NCT01263314|Secondary|The Time Weighted Average Systolic Blood Pressure (SBP) Evaluated Over 8 Hours Post Dose (TWA[0-8hrs]) Following a Single Oral Dose of MK-8266.|Participants rested for at least 10 minutes prior to having vital sign measurements obtained. Single dose effects on central SBP were estimated as a time-weighted average over the 8-hour post single dose observation period.|Up to 8 hours post dose in each dosing period (Up to 8 hours)|The analysis population was all participants who received at least 1 dose of the investigational drug.|||millimeters of mercury||Standard Deviation|Least Squares Mean
2697354|NCT01263314|Secondary|MK-8266 PK Parameter Apparent Half-Life (t1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. Results are presented for the Harmonic Mean ± Pseudo standard deviation.|Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.|The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. t1/2 was not estimated for participants receiving placebo and for MK-8266 doses below 0.6 mg due to the lack of measureable concentrations.|||Hours||Standard Deviation|Mean
2697355|NCT01263314|Secondary|MK-8266 PK Parameter Observed Time to Reach Cmax (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. Nominal instead of actual times are presented.|Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.|The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Tmax was not estimated for participants receiving placebo.|||Hours||Full Range|Median
2697356|NCT01263314|Secondary|MK-8266 PK Parameter Observed Maximum (Peak) Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.|The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Cmax was not estimated for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2697357|NCT01263314|Secondary|MK-8266 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (AUC[0-inf]) is a measure of the mean concentration levels of drug in the plasma after the dose.|Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.|The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. AUC[0-inf] was not estimated for participants receiving placebo and for MK-8266 doses below 0.6 mg due to the lack of measureable concentrations.|||nM•hr||Standard Deviation|Mean
2697358|NCT01263314|Primary|Number of Participants With Abnormal Electrocardiograms (ECG) Reported as an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An abnormal ECG value was any AE reported under the System Organ Classes of Investigations or Cardiac that was related to an abnormal ECG value.|Up to 48 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2697359|NCT01263314|Primary|Change From Baseline in Heart Rate|Participants rested for at least 10 minutes prior to having vital sign measurements obtained. Heart rate measurements were obtained in the semirecumbent position and 3 sets of measurements were obtained approximately 1 minute apart.|Baseline and 0 to 8 hours postdose|All participants who received at least one dose of the investigational drug.|||Beats per minute||Standard Deviation|Least Squares Mean
2697360|NCT01263314|Primary|Change From Baseline in Systolic Blood Pressure (SBP)|Participants rested for at least 10 minutes prior to having vital sign measurements obtained.|Baseline and 0 to 8 hours postdose|All participants who received at least one dose of the investigational drug.|||Millimeters of mercury||Standard Deviation|Least Squares Mean
2697361|NCT01263314|Primary|Number of Participants With Abnormal Laboratory Urinalysis Values Reported as an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory urinalysis value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory urinalysis value.|Up to 37 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2697362|NCT01263314|Primary|Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.|Up to 48 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2697363|NCT01263314|Primary|Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.|Up to 48 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2697364|NCT01263314|Primary|Number of Participants With Adverse Events (AEs)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 48 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2697365|NCT01263301|Primary|no Change of Vertebral Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|2 years|as above explained|||participants|||Number
2697366|NCT01263301|Primary|Change of Vertebral Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|two year|determined as above explained|||participants|||Number
2697367|NCT01263301|Primary|no Change of Subclavian Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|one year|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.|||participants|||Number
2697368|NCT01263301|Primary|Change of Subclavian Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|two years|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.|||participants|||Number
2697369|NCT01263223|Secondary|Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4|BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 4|All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses.|||millimeter of mercury (mm Hg)||90% Confidence Interval|Least Squares Mean
2697370|NCT01263223|Primary|Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4|Heart rate was determined during ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from 24 hour continuous ABPM monitoring for Day 4 (0 to 24 hours). LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 4|All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 were made in Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.|||beats per minute (bpm)|Observations|90% Confidence Interval|Least Squares Mean
2697919|NCT01259596|Primary|Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13|self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
2697371|NCT01263223|Secondary|Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4|Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 4|All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses.|||beats per minute (bpm)||90% Confidence Interval|Least Squares Mean
2697372|NCT01263223|Secondary|Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4|BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 4|All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 36-mg LY2216684 included Period 3. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.|||millimeter of mercury (mm Hg)|Observations|90% Confidence Interval|Least Squares Mean
2697373|NCT01263223|Secondary|Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4|Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 4|All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 36-mg LY2216684 included Period 3. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.|||beats per minute (bpm)|Observations|90% Confidence Interval|Least Squares Mean
2697374|NCT01263223|Secondary|Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4|BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 4|All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.|||millimeter of mercury (mm Hg)|Observations|90% Confidence Interval|Least Squares Mean
2697375|NCT01263223|Secondary|Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1|Blood pressure (BP) was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 1. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 1|All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.|||millimeter of mercury (mm Hg)|Observations|90% Confidence Interval|Least Squares Mean
2697376|NCT01263223|Primary|Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1|Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.|Baseline through the 24-hour interval on Day 1|All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.|||beats per minute (bpm)|Observations|90% Confidence Interval|Least Squares Mean
2697377|NCT01263197|Secondary|Maximum, Minimum and Average Changes in Diastolic Blood Pressure|Diastolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline diastolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose diastolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose diastolic blood pressure for a day was the average diastolic blood pressure for 24 hours. The least squares (LS) mean change from baseline diastolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.|Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours)|Randomized participants with at least 1 postdose diastolic blood pressure measurement.|||millimeters of mercury (mm Hg)||90% Confidence Interval|Least Squares Mean
2699002|NCT01252277|Secondary|Modulation of Ki-67 Expression|Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67|6 month value compared to baseline value||||Change in percent Ki-67 expression||Inter-Quartile Range|Median
2697378|NCT01263197|Secondary|Maximum, Minimum and Average Changes in Systolic Blood Pressure|Systolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline systolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose systolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose systolic blood pressure for a day was the average systolic blood pressure for 24 hours. The least squares (LS) mean change from baseline systolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.|Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours)|Randomized participants with at least 1 postdose systolic blood pressure measurement.|||millimeters of mercury (mm Hg)||90% Confidence Interval|Least Squares Mean
2697379|NCT01263197|Primary|Maximum, Minimum and Average Changes in Heart Rate|Using a Holter monitor, heart rate was recorded every 10 minutes through 24 hours postdose on Days 1, 3, and 5 of each period. Baseline heart rate was the average of 10-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose heart rate was summarized over 1-hour increments using the average of the 10-minute readings within these intervals. The postdose heart rate for a day was the average heart rate for 24 hours. The least squares (LS) mean change from baseline heart rate is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.|Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 10 minutes through 24 hours postdose)|Randomized participants with at least 1 postdose heart rate measurement.|||beats per minute (bpm)||90% Confidence Interval|Least Squares Mean
2697380|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 6 (Week 4)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
2697381|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 5 (Week 3)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 5 (Week 3)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
2697382|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 4 (Week 2)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 4 (Week 2)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
2697383|NCT01263132|Secondary|Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire|SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.|Visit 2 (Baseline) to Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included.|||Units on a Scale||Standard Deviation|Mean
2697384|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 3 (Week 1)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 3 (Week 1)|Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
2697385|NCT01263119|Secondary|Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax)|INR is the ratio of a participant's prothrombin time to a normal (control) sample. INRmax was calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.|Predose, 6, 12, 24, 48, 72, 96, 120, 144 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.|||ratio||90% Confidence Interval|Number
2697386|NCT01263119|Secondary|Pharmacodynamics: Area Under the Curve of the International Normalized Ratio (AUCINR) of Warfarin|The INR is the ratio of a participant's prothrombin time to a normal (control) sample. AUCINR was calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.|Predose, 6, 12, 24, 48, 72, 96, 120, 144 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.|||ratio||90% Confidence Interval|Number
2697785|NCT01260883|Primary|Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants|population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery|24 hours after surgery|of 52 enrolled infants aged 6-18 months, 37 completed the study. Of these, 25 received drug, 12 placebo.Doses of 0.5 or 1 mg/kg showed no difference in handling so reported together.|||ml||Standard Error|Mean
2697387|NCT01263119|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-Warfarin|This outcome was measured based on Tmax of R-warfarin on Day 1 of Period 1 when warfarin was administered alone (reference) and on Day 3 of Period 2 when coadministered with LY2216684 (test).|Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.|||h||Full Range|Median
2697388|NCT01263119|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of R-Warfarin|Least Squares (LS) geometric mean was based on Cmax of R-warfarin; calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.|Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.|||ng/mL||90% Confidence Interval|Geometric Mean
2697389|NCT01263119|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of R-Warfarin|Least Squares (LS) geometric mean was based on AUC0-∞ of R-warfarin; calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.|Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.|||ng*h/mL||90% Confidence Interval|Geometric Mean
2697390|NCT01263119|Primary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of S-Warfarin|This outcome was measured based on Tmax of S-warfarin on Day 1 of Period 1 when warfarin was administered alone (reference) and on Day 3 of Period 2 when coadministered with LY2216684 (test).|Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who had at least 1 dose of warfarin and had evaluable concentration data.|||hour (h)||Full Range|Median
2697391|NCT01263119|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of S-Warfarin|Least Squares (LS) geometric mean was based on Cmax of S-warfarin; calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.|Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who received at least 1 dose of warfarin and had evaluable concentration data.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2697392|NCT01263119|Primary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of S-Warfarin|Least Squares (LS) geometric mean was based on AUC0-∞ of S-warfarin; calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.|Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3|The analysis population included participants who received at least 1 dose of warfarin and had evaluable concentration data.|||nanogram*hour per milliliter (ng*hr/mL)||90% Confidence Interval|Geometric Mean
2697393|NCT01263106|Secondary|Mean Change From Baseline in Heart Rate: 18 mg LY221684 + 200 mg Theophylline||Baseline, Day 1, Day 3|The safety population included participants who were randomized, received study drug, and had at least 1 post-dose safety assessment.|||beats per minute (bpm)||Standard Deviation|Mean
2697394|NCT01263106|Secondary|Mean Change From Baseline in Heart Rate: 200 mg Theophylline||Baseline, Day 1|The safety population included participants who were randomized, received study drug, and had at least 1 post-dose safety assessment.|||beats per minute (bpm)||Standard Deviation|Mean
2697395|NCT01263106|Primary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Theophylline|This outcome was measured based on Tmax for theophylline on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.|Predose 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-administration of theophylline on Days 1 and 3|The safety population included participants who were randomized, received study drug, and had at least 1 post-dose safety assessment.|||hour (h)||Full Range|Median
2697396|NCT01263106|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Theophylline|The Least Squares (LS) geometric mean was based on Cmax for theophylline on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.|Predose 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-administration of theophylline on Days 1 and 3|The safety population included participants who were randomized, received study drug, and had at least 1 post-dose safety assessment.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2697397|NCT01263106|Primary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Theophylline|The Least Squares (LS) geometric mean was based on AUC0-∞. The AUC for theophylline was calculated on Day 1 of a given period when theophylline was administered alone and on Day 3 of another period when theophylline was coadministered with LY2216684.|Predose 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-administration of theophylline on Days 1 and 3|The safety population included participants who were randomized, received study drug, and had at least 1 post-dose safety assessment.|||nanogram*hour per milliliter (ng*h/mL)||90% Confidence Interval|Geometric Mean
2697398|NCT01263093|Primary|Pharmacokinetics of R-130964, Time to Maximum Observed Drug Concentrations (Tmax)|R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684.|predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose|Participants with the CYP2C19*1/*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data.|||hours||Full Range|Median
2697399|NCT01263093|Secondary|Percentage Inhibition of Platelet Aggregation|Blood samples for the measurement of platelet aggregation using a point-of-care device, Accumetrics VerifyNow™ P2Y12 (VN-P2Y12), were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Device-reported percent inhibition of VN-P2Y12 (IPRU) is presented.|predose and 2, 4, and 24 hours postdose|Participants with the CYP2C19*1/*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable IPRU data.|||IPRU||Standard Deviation|Mean
2697400|NCT01263093|Primary|Pharmacokinetics of R-130964, Maximum Observed Drug Concentrations (Cmax)|R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed Cmax was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect.|predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose|Participants with the CYP2C19*1/*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2697401|NCT01263093|Primary|Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-tlast)|R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684. Log-transformed AUC0-tlast was analyzed using a linear mixed effects model with sequence, period, and treatment as fixed effects and participant as a random effect.|predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose|Participants with the CYP2C19*1/*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data.|||hours*nanograms/milliliters (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2697402|NCT01263093|Primary|Pharmacokinetics of R-130964, Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|R-130964 is the active metabolite of clopidogrel. Blood samples were collected prior to and through 24 hours after administration of clopidogrel alone and in combination with LY2216684.|predose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 hours postdose|Participants with the CYP2C19*1/*1 genotype, who received at least 1 dose of clopidogrel, and had evaluable R-130964 plasma concentration data, including sufficient data in the terminal elimination phase for R-130964.|||hours*nanograms/milliliters (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2697403|NCT01263054|Secondary|Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit|"ODI - score range = 0 - 100. 0 corresponds to no disability and 100 indicates the maximum disability possible. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 Months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
2697404|NCT01263054|Secondary|Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit|"PGIC - score range = 1 - 7. 1 corresponds to very much improved and 7 indicates very much worse pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Error|Mean
2697405|NCT01263054|Secondary|Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit|"BDI - score range = 0 - 63. 0 corresponds to minimal depression and 63 indicates severe depression. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
2697406|NCT01263054|Secondary|Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit|"EQ-5d VAS - score range = 0 - 100. 0 corresponds to the worst imaginable health state and 100 indicates the best imaginable health state. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
2697407|NCT01263054|Secondary|Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit|"Short Form 36-PF - score range = 0 - 100. 0 corresponds to greatest disability and 100 indicates no disability. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
2697408|NCT01263054|Secondary|Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months||||percentage of study group|||Number
2697409|NCT01263054|Primary|Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
2697410|NCT01263028|Secondary|Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders||24 Weeks|||||||
2697411|NCT01263028|Secondary|Change in Iron Supplementation||24 Weeks|||||||
2697412|NCT01263028|Secondary|Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels||24 Weeks|||||||
2697413|NCT01263028|Secondary|Change in Inflammatory Markers||24 Weeks|||||||
2697414|NCT01263028|Primary|Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements||24 Weeks|||||||
2697441|NCT01262976|Secondary|Frequency of M72-cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Immune Markers|Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). This endpoint presents results for CD4-all doubles.|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697415|NCT01263015|Secondary|Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48|"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, I do not have this symptom; 1, It doesn't bother me; 2, It bothers me a little; 3, It bothers me; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS."|Baseline and Week 4 through 48|ITT-E Population. Participants with missing bother item scores at Week 4 had their last observation carried forward (LOCF). Only those participants contributing to the model (i.e., without missing response variables after LOCF or covariates) were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2697416|NCT01263015|Secondary|Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144|Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG.|Through Week 144|PDVF Genotypic Population: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF|||Participants|||Number
2697417|NCT01263015|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.|From Baseline until Week 144|Safety Population: all participants who received at least one dose of investigational product|||Participants|||Number
2697418|NCT01263015|Secondary|Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline until Week 144|ITT-E Population|||Participants|||Number
2697419|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population|||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
2697420|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Week 144|Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured.|Baseline and Week 144|ITT-E Population|||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Least Squares Mean
2697421|NCT01263015|Secondary|Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144|Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population|||log10 copies/mL||Standard Deviation|Mean
2699354|NCT01250730|Primary|Dose Normalized AUClast of Crizotinib|Dose normalized (to 150 mg dose) AUClast is obtained from AUClast / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
2697422|NCT01263015|Secondary|Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24|Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population|||Participants|||Number
2697423|NCT01263015|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 96 and Week 144|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2697424|NCT01263015|Secondary|Time to Viral Suppression (<50 c/mL)|Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population|||Days||95% Confidence Interval|Median
2697425|NCT01263015|Primary|Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2697426|NCT01262989|Primary|Cmax|"Cmax is defined as the maximum or peak concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed."|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
2697427|NCT01262989|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study|||ng/h/ml||Standard Deviation|Mean
2697428|NCT01262989|Primary|AUC0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study|||ng per hour per ml (ng/h/ml)||Standard Deviation|Mean
2697429|NCT01262976|Secondary|Number of Subjects Presenting Different Grades of Haematological and Biochemical Values|Biochemical and haematological parameters included haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. Levels assessed were - normal, grade 1, grade 2 and missing grade. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.|At Days 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697430|NCT01262976|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From one month post Dose 2 up to study end (Year 3)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2715733|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4||28 Days|Participants with available data at Week 4.|||percentage of participants|||Number
2697431|NCT01262976|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697432|NCT01262976|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (Gastro), headache, malaise, myalgia and temperature. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in their symptom sheets.|||Participants|||Count of Participants
2697433|NCT01262976|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms assessed were pain and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in their symptom sheets.|||Participants|||Count of Participants
2697434|NCT01262976|Secondary|M72-CD8+ T-cells Frequency Expressing Any Combination of Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD8.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+), CD8.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697435|NCT01262976|Secondary|M72-cluster of Differentiation 8 (CD8+) T Frequency Cells Expressing Any Combination of Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-).|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697436|NCT01262976|Secondary|Frequency of M72-CD8+ T-cells Expressing Any Combination of Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L) interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD8.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD8.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697437|NCT01262976|Secondary|Frequency of M72-cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers|Among immune markers expressed after background reduction were interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for CD8-all doubles.|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697438|NCT01262976|Secondary|M72-CD4+ T-cells Frequency Expressing Any Combination of Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(+), CD4.CD40L(-)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(-)+IL2(-)+TNFa(-)+IFNg(+).|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697439|NCT01262976|Secondary|M72-cluster of Differentiation 4 (CD4+) T-cells Frequency Expressing Any Combination of Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combination: CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(-), CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(-)+TNFa(-)+IFNg(-),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(+),CD4.CD40L(-)+IL2(+)+TNFa(+)+IFNg(-)|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697440|NCT01262976|Secondary|Frequency of M72-CD4+ T-cells Expressing Any Combination of Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). This endpoint presents results for the following cytokine combinations: CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(+), CD4.CD40L(+)+IL2(+)+TNFa(+)+IFNg(-),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(+),CD4.CD40L(+)+IL2(+)+TNFa(-)+IFNg(-),CD4.CD40L(+)+IL2(-)+TNFa(+)+IFNg(+).|At Days 0, 7, 30, 37, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2697442|NCT01262976|Secondary|Number of Seroconverted Subjects for M72-specific Antibodies|A seroconverted subject for M72 antibodies was defined as a seronegative subject at baseline, with the appearance of M72 antibody concentration higher than or equal to (≥) the cut-off value of 2.8 EL.U/mL post vaccination. Antibody concentrations below the cut-off value of the assay were given an arbitrary value of half the cut-off value for the purpose of GMC calculation.|At Days 0, 30, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2697443|NCT01262976|Secondary|Anti-Mycobacterium Tuberculosis Fusion Protein (M72) Specific Antibody Concentrations|Concentration of M72-specific antibodies, as measured by the enzyme-linked immunosorbent assay (ELISA), were given in ELISA units per milliliter (EU/mL) and expressed as geometric mean concentrations (GMCs).|At Days 0, 30, 60, 210 and at Years 1, 2 and 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2697444|NCT01262976|Primary|Number of Subjects With Grade 3-4 Haematological/Biochemical Levels|Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697445|NCT01262976|Primary|Number of Subjects With Grade 3-4 Haematological and Biochemical Levels|Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697446|NCT01262976|Primary|Number of Subjects With Grade 3 and Grade 4 Haematological/Biochemical Levels|Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697447|NCT01262976|Primary|Number of Subjects With Grade 3 and 4 Haematological and Biochemical Levels|Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697448|NCT01262976|Primary|Number of Subjects With Grade 3 and Grade 4 Haematological and Biochemical Levels|Haematological and biochemical parameters assessed were haemoglobin [Hgb], white blood cells [WBC], platelets [PLA], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CREA]. The haematology and biochemistry toxicity grading scale was based on the Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697449|NCT01262976|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening up to one month post Dose 2|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697450|NCT01262976|Primary|Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2697451|NCT01262976|Primary|Number of Subjects With Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fatigue, temperature [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Participants|||Count of Participants
2697452|NCT01262976|Primary|Number of Subjects With Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Participants|||Count of Participants
2714383|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Placebo to Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
2697453|NCT01262898|Secondary|Change From Baseline in Whole Bowel Transit Time, 100 % Gastric Emptying Time (Truncated at 240 Minutes), Small Bowel Transit Time, Colonic Transit Time as Determined by Wireless Motility Capsule (WMC)|WMC is an ingestible telemetric capsule which measures pH, pressure and temperature to assess total gastric emptying time, small and large bowel transit time, colonic transit time, and whole gut transit time. The WMC was ingested immediately following the standard test meal for the oral breath test. Data was collected on a data logger, which was worn on a belt clip. The WMC passed naturally in the participant's stools between 2 and 5 days after ingestion. The parameters Whole bowel transit time, 100 % gastric emptying time (truncated at 240 minutes), small bowel transit time, colonic transit time were analyzed. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline(Screening i.e., Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||minutes||Standard Deviation|Mean
2697454|NCT01262898|Secondary|Change From Baseline in Upper Gastrointestinal (GI) Symptoms as Assessed by Total Gastrointestinal Cardinal Symptom Index - Daily Diary (GCSI-DD)|"GCSI-DD was measured on a 6-point scale. The Total GCSI-DD score was the mean of the following three subscales: Nausea/Vomiting Subscale = mean (nausea, retching, vomiting), Fullness/Early Satiety Subscale = mean (feeling excessively full after meals, not able to finish a normal-sized meal, stomach fullness, loss of appetite), Bloating Subscale = mean (bloating, stomach or belly visibly larger). Each subscale was scored on a severity scale of 0 (none) to 5 (very severe), with lower scores representing less symptom severity. The change from Baseline to each study week in average score was derived and if it improved by 1 point or more, that participant was defined as responder for that symptom and on that particular week. Baseline was Screening2/Baseline values (Day -30 to -1). Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value."|Up to 14 days post last dose (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2697455|NCT01262898|Secondary|Daily Average Stool Consistency|Stool consistency was determined on a scale of 1 to 5 (1 = Very hard, 2 = Hard, 3 = Formed, 4 = Loose, 5 = Watery). Following dosing with study medication, stool monitoring was performed up to Day 28. Participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.|Up to Week 4 (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.|||Bowel Movements/ 24 hours||Standard Deviation|Mean
2697456|NCT01262898|Secondary|Daily Bowel Movement Frequency|Daily bowel movement frequency analyzed number of times passed stools in 24 hours of duration. Following dosing with study medication, stool monitoring was performed up to Day 28. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.|Up to Week 4 (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.|||Bowel movements/24 hours||Standard Deviation|Mean
2697457|NCT01262898|Secondary|Time to First Bowel Movement After First Dose|The time to first bowel movement was calculated as the time of the first bowel movement after the first dose in hours (floored) for each participant. If a participant had fewer than 5 days worth of data then the daily mean for that week was set to missing for the following two parameters: Bowel Movement Count and Stool Consistency. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics of time to first bowel movement.|Up to Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||hours||Standard Deviation|Mean
2697458|NCT01262898|Secondary|Apparent Terminal Elimination Half-life (t1/2) at Specified Time Points|This outcome measure was not analyzed in results.|The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however, the data for this outcome measure was not collected.|PK Population. The data for this outcome measure was not collected.||||||
2697459|NCT01262898|Secondary|Apparent Volume of Distribution (V/F) at Specified Time Points|The apparent volume of distribution V/F = CL/F × MRT, where MRT is the mean residence time. The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however, the data for this outcome measure was not collected.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK Population. The data for this outcome measure was not collected.||||||
2697460|NCT01262898|Secondary|Apparent Clearance Following Oral Dosing (CL/F) at Specified Time Points|CL/F was calculated as dose/AUC. The parameter was planned to be analyzed from samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however the data for this outcome measure was not collected.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK Population. The data for this outcome measure was not collected.||||||
2697461|NCT01262898|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ct) at Specified Time Points|Analysis of pre-dose (trough) concentration at the end of the dosing interval (Ct) was planned to be performed from the samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population.|||Liters||Standard Deviation|Mean
2697462|NCT01262898|Secondary|Time of Occurrence of Cmax (Tmax) at Specified Time Points|Tmax is defined as the time to reach the observed maximum concentration. Samples were collected at the following times: Tmax was determined directly from the raw concentration-time data. Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population. Only those participants available at specified time points were analyzed.|||Hour||Standard Deviation|Mean
2697463|NCT01262898|Secondary|Maximum Observed Concentration (Cmax) at Specified Time Points|Cmax is defined as the maximum observed drug concentration after administration. Cmax was determined directly from the raw concentration-time data. Samples were collected at the following times: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population. Only those participants available at specified time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2699071|NCT01251757|Secondary|Percentage With Good (>80%) Statin Adherence|Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking statins at the time of randomization.|||percent with good adherence|||Number
2697464|NCT01262898|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration AUC(0-t) at Specified Time Points|AUC(0-t) was derived from GSK962040 plasma concentration-time data. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.Only participants who received GSK962040 drug were analyzed.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|The ‘Pharmacokinetic (PK) Population' was defined as participants in the ‘All subjects’ population for whom a PK sample was obtained and analyzed. Only those participants available at specified time points were analyzed.|||Nanograms.hour/milliliter (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
2697465|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Red Blood Cell Count, Reticulocytes|Red Blood Cell count, Reticulocytes measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Tera (10^12) cells per liter (TI/L)||Standard Deviation|Mean
2697466|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Volume|Mean Corpuscle Volume measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
2697467|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Hemoglobin, Mean Corpuscle Hemoglobin Concentration|Hemoglobin, Mean Corpuscle Hemoglobin concentration measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||g/L||Standard Deviation|Mean
2697468|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Hemoglobin|Mean Corpuscle Hemoglobin measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Picograms (Pg)||Standard Deviation|Mean
2697469|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Hematocrit|Hematocrit measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2697470|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet Count, White Blood Cell Count|Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet count, White Blood cell count measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
2697471|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry : Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon Dioxide Content/Bicarbonate|Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon dioxide content/Bicarbonate measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
2697472|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry : Albumin, Total Protein|Albumin, Total Protein measurements were taken at Baseline (Day 1 pre-dose), and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2697473|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid|Direct Bilirubin, Total Bilirubin, Creatinine, Uric acid measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Unit moles per litre (UMOL/L)||Standard Deviation|Mean
2697474|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase|Alkaline phosphatase, alanine amino transferase, aspartate amino transferase, gamma glutamyl transferase, creatine kinase, lactate dehydrogenase measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2697494|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697475|NCT01262898|Secondary|Number of Participants Outside the Normal Range for 12-lead ECG|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The CCR for ECG parameters were: PR interval (<110 and >220), QRS interval (<75 and >110), Absolute QTc interval (>450 to =< 480) respectively. Baseline was the pre-dose reading for Day 1. Data for abnormal- clinically significant (ACS) and abnormal- not clinically significant (ANCS) has been presented.|Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Participants|||Number
2697476|NCT01262898|Secondary|Number of Participants Outside the Normal Range for Heart Rate|Heart rate measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The CCR for heart rate was Increase or decrease by less than or equal to (>=) 15 and >= 30. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.|Screening2/Baseline (Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Participants|||Number
2697477|NCT01262898|Secondary|Number of Participants Outside the Normal Range for SBP and DBP|Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The clinical concern range (CCR) for SBP was greater than (<) 85 and less than (>) 160 and for DBP the range was <45 and >100. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.|Screening2/Baseline (Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Participants|||Number
2697478|NCT01262898|Secondary|Change From Baseline in Electrocardiography Parameters (12-lead ECG)|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The Baseline value was the Day 1 pre-dose value. ECG parameters included PR interval, QRS duration, QT interval, QTcB, QTcF and RR interval.|Baseline, Day 1 and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
2697479|NCT01262898|Secondary|Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position|Heart rate measurements were taken at pre-dose and 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values . Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population. Only those participants available at specified time points were analyzed.|||Beats per minute (BPM)||Standard Deviation|Mean
2697480|NCT01262898|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position|Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population. Only those participants available at specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2697481|NCT01262898|Secondary|Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Data for on-treatment adverse events is reported.|Up to follow-up (5-10 days post last dose)|All Subjects population.|||Participants|||Number
2697482|NCT01262898|Primary|Gastric Half Emptying Time (GEt1/2)|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 28, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes(min) later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28|The ‘All Subjects Population’ compromised of all participants who received at least one dose of study medication. Only those participants available at specified time points were analyzed.|||Minutes||Standard Deviation|Mean
2697483|NCT01262872|Other Pre-specified|Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2|Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Percentage of protein identity|||Number
2697484|NCT01262872|Other Pre-specified|Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2|Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed. PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix). The samples without gene detected were considered as negative for PhtD (PhtD negative).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
2715734|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8||56 Days|Participants with available data at Week 8.|||percentage of participants|||Number
2697485|NCT01262872|Other Pre-specified|Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2|Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Percentage of protein identity|||Number
2697486|NCT01262872|Other Pre-specified|Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2|Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant. The samples without gene detected were considered as negative for Ply (Ply negative).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
2697487|NCT01262872|Other Pre-specified|Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2|Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
2697488|NCT01262872|Other Pre-specified|Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2|Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
2697489|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697490|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697491|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697492|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697493|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697495|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697496|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697497|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697498|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697499|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697500|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697501|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697502|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697503|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697504|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697968|NCT01259245|Primary|SGRQ HKC-Activity|SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
2697505|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697506|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697507|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697508|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697509|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697510|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697511|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697512|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2698769|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)|Clinical laboratory assessments for ALAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||IU/L||Standard Deviation|Mean
2697513|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697514|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697515|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697516|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697517|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697518|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697519|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697520|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697521|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697522|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2697523|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2697524|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697525|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697526|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2697527|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2697528|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697529|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697635|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) during open-label treatment period|||participants|||Number
2697530|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2697531|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2697532|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2697533|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2697534|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697535|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697536|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697537|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697538|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697539|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697540|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697541|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697542|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697543|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697544|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697545|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697546|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697547|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697548|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697549|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697550|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697551|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697552|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2697553|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2697554|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2697555|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2697636|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)|||participants|||Number
2697556|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects|Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697557|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697558|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697559|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2697560|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
2697561|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697562|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2697563|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects|Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||LU/mL||95% Confidence Interval|Geometric Mean
2697564|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects|Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||LU/mL||95% Confidence Interval|Geometric Mean
2697786|NCT01260883|Primary|Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants|stereo-specific ketorolac clearance by population-based analysis (NONMEM)|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded for abnormal laboratory results or intravenous sampling catheters that did not allow sampling. 25 infants aged 6-18 months received ketorolac, 12 received placebo. Doses of 0.5 or 1 mg/kg reported together since no difference found in handling.|||ml/min||Standard Error|Mean
2697565|NCT01262872|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697566|NCT01262872|Secondary|Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects|Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697567|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697568|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697569|NCT01262872|Primary|Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697570|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697571|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2714384|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Nexium Alone.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
2697572|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2697573|NCT01262846|Primary|Immunogenicity|To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.|Baseline to 21 days|All participants except 5 participants with missing data at day 21|||Geometric Mean antibody titer||95% Confidence Interval|Geometric Mean
2697574|NCT01262820|Secondary|Overall Survival|Overall survival is defined as the time of enrollment until death|Eight (8) months w additional time for response date to mature (up to 2 years per participant)||||weeks||95% Confidence Interval|Median
2697575|NCT01262820|Secondary|Progression Free Survival|Progression free survival is defined as time of enrollment until disease progression or death Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Progression is defined as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Target lesions are representative of all involved organs and measurable by radiographic imaging.|Eight (8) months w additional time for response data to mature (up to 2 years per participant)||||weeks||95% Confidence Interval|Median
2697576|NCT01262820|Secondary|Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1|Estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions.Target lesions are representative of all involved organs and measurable by radiographic imaging.|8 months with additional time for response to mature (up to 2 years per participant)||||participants|||Number
2697577|NCT01262820|Primary|Disease Control Rate|Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging.|Eight (8) months w additional time for response date to mature (up to 2 years per participant)||||% of participants with disease control||95% Confidence Interval|Number
2697578|NCT01262755|Primary|Epidemiologic Factors Associated With Prevalent Reflux Disease.|Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 450 African Americans living in North Philadelphia.|Two years|Patients successfully identified from targeted area.|||percentage of participants with GERD||95% Confidence Interval|Number
2697579|NCT01262677|Secondary|Percentage of Participants With Laboratory Test Abnormalities During the Study|Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697580|NCT01262677|Secondary|Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase|The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.|Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697581|NCT01262677|Secondary|Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms|The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.|Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697637|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) for open label-treatment period|||participants|||Number
2714421|NCT01141647|Secondary|Employment Rate|Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.|24 Months||||percentage of participants with CE|||Number
2697582|NCT01262677|Secondary|Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase|Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697583|NCT01262677|Secondary|Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)|C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.|Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697584|NCT01262677|Secondary|Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase|Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697585|NCT01262677|Secondary|Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase|Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
2697586|NCT01262677|Secondary|BSW: Willingness to Continue Question|The BSW consisted of 3 single-item measures designed to capture the participant`s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
2697587|NCT01262677|Secondary|BSW: Satisfaction From Treatment Question|The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
2697588|NCT01262677|Secondary|Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question|The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
2697589|NCT01262677|Secondary|Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale|Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
2697638|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|From Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)|||participants|||Number
2699355|NCT01250730|Primary|Dose Normalized AUC(0-inf) of Crizotinib|Dose normalized (to 150 mg dose) AUC(0-inf) is obtained from AUC(0-inf) / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
2697590|NCT01262677|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697591|NCT01262677|Secondary|Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697592|NCT01262677|Secondary|Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697593|NCT01262677|Secondary|Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697594|NCT01262677|Secondary|Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||hours||Standard Deviation|Mean
2697595|NCT01262677|Secondary|Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697596|NCT01262677|Secondary|Change From Baseline in MOS-SS - Snoring Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2698770|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Urea|Clinical laboratory assessments for urea at week 24 to end ot trial visit.|Every 6th month, week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmol/L||Standard Deviation|Mean
2697597|NCT01262677|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697598|NCT01262677|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697599|NCT01262677|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
2697600|NCT01262677|Secondary|Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 2 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln(28-day seizure rate)||Standard Error|Least Squares Mean
2697601|NCT01262677|Secondary|Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
2697602|NCT01262677|Secondary|Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 2 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln (seizures per 28 days)||Standard Error|Least Squares Mean
2697603|NCT01262677|Secondary|Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||seizures per 28 days||Standard Deviation|Mean
2697604|NCT01262677|Secondary|Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln (seizures per 28 days)||Standard Error|Least Squares Mean
2697605|NCT01262677|Secondary|Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
2697606|NCT01262677|Primary|Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 0 to Week 14|The intent-to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln (seizures per 28 days)||Standard Deviation|Mean
2697607|NCT01262651|Secondary|Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was no constipation, and 10 was constipation as bad as you can imagine. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.~A negative value indicates improvement in condition from Baseline."|Baseline, Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2697608|NCT01262651|Secondary|Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment|"Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalents dose usages for each break-through opioid was calculated for the summary.~Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Baseline daily break-through opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2697609|NCT01262651|Secondary|Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment|"The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: Have you used your maintenance dose painkiller today as prescribed? If the participant answered No to the question, the daily opioid maintenance dose usage on that day was set to 0.~Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Baseline daily maintenance opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2697610|NCT01262651|Secondary|Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment|"The total daily opioid use (in morphine equivalence) was the sum of morphine equivalents of daily maintenance dose and break-through dose.~Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Baseline daily total opioid use.~A negative value indicates a decrease in use from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2697611|NCT01262651|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)|"The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers Extremely satisfied, Very satisfied, Slightly satisfied, Neutral, Slightly dissatisfied, Very dissatisfied, Extremely dissatisfied. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36."|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2697612|NCT01262651|Secondary|Physician Global Impression Of Change At Last Visit (Up To Day 36)|"The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: Very much worse, Much worse, Slightly worse, No change, Slightly improved, Much improved, Very much improved. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36."|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2697787|NCT01260883|Secondary|Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants|continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo|12 hours after ketorolac or placebo infusion|25 infants aged 2-6 months enrolled; 11 excluded. 8 received ketorolac, 6 placebo|||percentage of time in 12 h after drug||Full Range|Median
2697613|NCT01262651|Secondary|Subject Global Impression Of Change At Last Visit (Up To Day 36)|"The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse. The SGIC was assessed at Day 36 or at which a participant's last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36."|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2697614|NCT01262651|Secondary|Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated did not disrupt sleep and a score of 10 indicated completely disrupted (unable to sleep at all). Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Baseline sleep disruption NRS score.~A negative value indicates an improvement in sleep disruption score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2697615|NCT01262651|Secondary|Change From Baseline In Mean NRS Worst Pain At End Of Treatment|"Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Baseline NRS worst pain score.~A negative value indicates an improvement in worst pain score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2697616|NCT01262651|Secondary|Change From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Baseline NRS average pain score.~A negative value indicates an improvement in average pain score from Baseline."|Baseline, End Of Treatment (Day 36)|ITT Population included all participants who receive at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2697617|NCT01262651|Primary|Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was no pain and 10 was pain as bad as you can imagine. Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated).~Percentage improvement from baseline (Imp%) was calculated as:~Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean * 100.~For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew unrelated to disease progression before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||percent improvement||Inter-Quartile Range|Median
2697618|NCT01262599|Secondary|Levels of Cytokines|Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.|24 hours|data reported at 24 hours postop|||pg/ml||Standard Deviation|Mean
2697619|NCT01262599|Secondary|Number of Narcotic Pain Medications|We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis|24 hours|data reported at 24 hours postop|||pills||Standard Deviation|Mean
2697620|NCT01262599|Primary|Pain Score Measured by Visual Analog Scale|We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.|12 hours||||units on a scale||Standard Deviation|Mean
2697621|NCT01262573|Secondary|Dyspareunia|Assessed preoperatively and up to 3 months postop|Postoperative||||participants|||Number
2697622|NCT01262573|Primary|Vaginal Cuff Closure Time|Average time (measured in minutes)|During the surgical procedure||||minutes||Standard Deviation|Mean
2697639|NCT01262456|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
2697788|NCT01260883|Secondary|Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery|total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo|first day after surgery|25 infants enrolled but 11 excluded. 8 received ketorolac, 6 placebo. total morphine given over 12 hours following infusion collected|||mg/kg||Standard Deviation|Mean
2697623|NCT01262560|Secondary|Patient Reported Difficulty in Swallowing Associated With Manuka Honey Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)|Change from baseline to four weeks in patient-reported difficulty in swallowing via the PRO-CTCAE. PRO-CTCAE is an item bank consisting of individual items to assess adverse symptom events from the patient perspective. There are 78 symptoms included in the survey but the primary item of interest assesses difficulty swallowing. For each AE in the PRO-CTCAE, between 1 and 3 items are included to assess the frequency, severity, and/or interference with activities related to that AE. Frequency questions have responses ranging from never, which is scored as a 0, to almost constantly, which is scored as a 4. Severity questions have responses ranging from none, which is scored as a 0, to very severe, which is scored as a 4. Interference questions have responses ranging from not at all, which is scored as a 0, to very much, which is scored as a 4. Difficulty in swallowing only has a severity question.|Baseline and 4 weeks from the start of treatment|Randomized eligible patients who started treatment with measure at both baseline and 4 weeks.|||units on a scale||Inter-Quartile Range|Median
2697624|NCT01262560|Secondary|Adverse Events Associated With Manuka Honey Using CTCAE v4.0|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Until 12 weeks from the start of treatment|Randomized eligible patients who started protocol treatment.|||percentage of patients|||Number
2697625|NCT01262560|Secondary|Percentage of Patients Using Opioids|The percentage of patients using opioid analgesics is reported. Use of opioid analgesics was assessed for a 24-hour period before completing the assessment. Patients with at least one reported administration of opioid analgesic were considered to have received opioid analgesics.|Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment|Randomized eligible patients with opioid use information at at least one time point.|||percentage of participants|||Number
2697626|NCT01262560|Secondary|Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)||Baseline and 4 weeks from the start of treatment|Randomized eligible patients with serum prealbumin at baseline and 4 weeks.|||mg/dl||95% Confidence Interval|Mean
2697627|NCT01262560|Secondary|Percent Change in Weight From Baseline to 4 Weeks||Baseline and 4 weeks from the start of treatment|Randomized eligible patients with weight at both baseline and 4 weeks.|||percentage of baseline value||95% Confidence Interval|Mean
2697628|NCT01262560|Secondary|Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For esophagitis specifically, Grade 3 criteria includes severely altered eating/swallowing, tube feeding, total parenteral nutrition (TPN) or hospitalization indicated. Grade 4 criteria include life-threatening consequences, urgent operative intervention indicated.|Up to 12 weeks from the start of treatment|Randomized eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
2697629|NCT01262560|Secondary|Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks|The pain symptom subscale (2 items) evaluated pain and the global score (30 items) evaluated quality of life. Each ranges from 0-100 with lower scores indicating lesser burden and improved symptoms or quality of life.|Baseline, 4 and 12 weeks from the start of treatment|Randomized eligible patients who received protocol treatment with at least 1 EORTC score completed across all time points.|||units on a scale||Inter-Quartile Range|Median
2697630|NCT01262560|Secondary|Dysphagia Via Daily Patient Log|"Dysphagia, as reported by the patient, was measured by the patient swallowing diary. Swallowing score has increasing severity 1-5, where 1 = none and 5 = cannot swallow liquids."|Weekly during treatment and 12 weeks from the start of treatment|Randomized eligible patients who received protocol treatment with at least one dysphagia score completed across all time points.|||units on a scale||Inter-Quartile Range|Median
2697631|NCT01262560|Secondary|Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS)|Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from values at the later time points. The experimental arms (honey) were compared to the standard arm (supportive care).|Baseline, weekly during treatment, and 12 weeks from the start of treatment|Eligible patients who started protocol treatment with at least 1 NRPS score completed across all time points|||units on a scale||Inter-Quartile Range|Median
2697632|NCT01262560|Primary|Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)|Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care).|Baseline and 4 weeks from the start of treatment|Randomized eligible patients with NRPS score at both baseline and 4 weeks.|||units on a scale||Inter-Quartile Range|Median
2697633|NCT01262547|Secondary|Incidence of Adverse Effects, Including Increased Activity of Vitiligo||24 weeks||||participants reporting redness|||Number
2697634|NCT01262547|Primary|Change in Target VASI Score From Baseline to Week 24.|Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).|24 weeks||||units on a scale||Full Range|Mean
2697658|NCT01262287|Primary|Change Number of Standard Drinks Per Week.|Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history|Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)||||standard drinks per week||Standard Error|Mean
2697640|NCT01262456|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
2697641|NCT01262456|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||minutes||Standard Deviation|Mean
2697642|NCT01262456|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||probability|||Number
2697643|NCT01262456|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||nocturnal voids||Standard Deviation|Mean
2697644|NCT01262456|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).|||probability|||Number
2697645|NCT01262456|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).|||nocturnal voids||Standard Deviation|Mean
2697646|NCT01262365|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 48|Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
2697647|NCT01262365|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 24|Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
2697659|NCT01262131|Primary|Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.|"Minimum scale value is '0' which represents 'no pain at all' and is the best outcome.~Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome."|2 weeks (baseline to end of treatment)|Analysis was by intention to treat which included all enrolled subjects in this case to study completion.|||Scores on a scale||Standard Deviation|Mean
2697804|NCT01260688|Secondary|Overall Response Rate|Best overall response rate of each evaluable patient|Duration of Study (median duration on study = 4 cycles)||||months||95% Confidence Interval|Median
2697648|NCT01262365|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 36|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
2697649|NCT01262365|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 12|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
2697650|NCT01262365|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
2697651|NCT01262365|Primary|The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
2697652|NCT01262352|Secondary|Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID). The primary analytical focus was the respiratory health domain, which was analyzed by combining all self-response questionnaire versions from different age groups (e.g., Adult/Adolescent and Child versions).|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||score on a scale||Standard Error|Least Squares Mean
2697653|NCT01262352|Secondary|Change From Baseline in Sweat Chloride|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||millimoles per liter||Standard Error|Least Squares Mean
2697654|NCT01262352|Secondary|Absolute Change From Baseline in Percent Predicted FEV1|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||percent||Standard Error|Least Squares Mean
2697655|NCT01262352|Primary|Absolute Change From Baseline in Lung Clearance Index (LCI)|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal SF6 concentration to 1/40th of the starting value.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||ratio||Standard Error|Least Squares Mean
2697656|NCT01262339|Primary|Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.||26 weeks|Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.||||||
2697657|NCT01262287|Secondary|Change in Standard Drinks Per Week - Moderation by Genetic Variation|Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)|Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)||||standard drinks per week||Standard Error|Mean
2697660|NCT01262118|Secondary|Cholesterol Efflux Rate|Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg/kg)/hr||Standard Deviation|Mean
2697661|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate|Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||%/hr||Standard Deviation|Mean
2697662|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate|HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/kg/hr||Standard Deviation|Mean
2697663|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate|Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS).|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||%/hr||Standard Deviation|Mean
2697664|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate|LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg/kg)/hr||Standard Deviation|Mean
2697665|NCT01262118|Secondary|Cholesterol Ester Fractional Catabolic Rate|Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage ester per hour (%/hr)||Standard Deviation|Mean
2697666|NCT01262118|Secondary|Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration|Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.|||mg/dL||Standard Deviation|Mean
2697667|NCT01262118|Primary|Cholesterol Ester Production Rate at Week 6|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg/kg)/hr||Standard Deviation|Mean
2697668|NCT01262118|Primary|Cholesterol Ester Production Rate at Baseline|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg per kilogram) per hour ([mg/kg]/hr)||Standard Deviation|Mean
2697669|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6|Blood level of HDL-C was measured following a 12-hours fasting.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.|||mg/dL||Standard Deviation|Mean
2697670|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline|Blood level of HDL-C was measured following a 12-hours fasting.|Baseline|Full analysis set (FAS) included all enrolled participants who had any measurement of cholesterol ester production rate available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2697671|NCT01262105|Primary|Surgery Site CFU Density|CFU culture counts for samples taken in surgery.|Ten-minute intervals throughout procedure||||CFU/m3||95% Confidence Interval|Mean
2697672|NCT01262092|Primary|Illicit Opioid Use as Determine by Urine Dipsticks|urine data are from those obtained during the buprenorphine taper|3x weekly during wks 3 and 4|Those who started the bup detox (N=24) excluding 1 subjects' data in the gabapentin group due to evidence of noncompliance with medication procedures and diversion (N=1).|||% of urines positive for opioids|Participants|Standard Error|Mean
2697673|NCT01262027|Secondary|Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)|Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section.|6 months||||Participants|||Count of Participants
2697687|NCT01261793|Primary|The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
2697674|NCT01262027|Primary|Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants|Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid|6 months|Three participants were not evaluable for response due to early departure from study.|||participants|||Number
2697675|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism presented in dioptres at each visit.|Visits 4-8|Surgically Induced Astigmatism—FAS Population|||Dioptres|Participants|Standard Deviation|Mean
2697676|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism was presented in dioptres at each visit.|Visits 1-3|Surgically Induced Astigmatism, FAS Population|||Dioptres|Participants|Standard Deviation|Mean
2697677|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|visit 5, visit 6, visit 7, visit 8|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
2697678|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|Visit 1, visit 2, visit 3, visit 4|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
2697679|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.|visit 5, visit 6, visit 7, visit 8|Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
2697680|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity|Visit 1, visit 2, visit 3, visit 4|Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
2697681|NCT01261975|Primary|Refractive Stability|Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.|12 weeks|Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)— Full analysis Set (FAS) Population|||Eyes|Participants||Number
2697682|NCT01261793|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 48|Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of participants|||Number
2697683|NCT01261793|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 24|Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of subjects|||Number
2697684|NCT01261793|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 36|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
2697685|NCT01261793|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 12|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
2697686|NCT01261793|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
2697688|NCT01261780|Secondary|Adverse Events|The number of participants experiencing adverse events, as defined by CTCAE|Up to 3 months||||participants|||Number
2697805|NCT01260688|Secondary|Non-AE Related Treatment Discontinuation|Non-Adverse Event related Treatment Discontinuation|Through study completion (median duration on study = 4 cycles)||||participants|||Number
2697689|NCT01261780|Primary|Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)|"Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points.~mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation.~Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline."|Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)|The number analyzed differs per row as some participants dropped out or did not receive all 10 treatments. For example, on the Sham Device arm, only 4 participants were treated on day 10 but 5 returned for the final visit. Because this was a pilot study, all participant data was analyzed and is included here.|||Millimeters||Standard Deviation|Mean
2697690|NCT01261624|Secondary|ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12|ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0- 100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 50, 70, 90 and 100 of response, defined as a 50%, 70%, 90% and 100% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|at week12||||participants|||Number
2697691|NCT01261624|Primary|ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment|ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0-100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 30 of response, defined as a 30% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|12 weeks of treatment||||participants|||Number
2697692|NCT01261611|Secondary|Percentage of Treatment Responders for Treatment Cycles 2 to 5|"A treatment responder was defined as a patient with >30% improvement in TWSTRS Total score compared to baseline.~TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms."|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Percentage of participants|||Number
2697693|NCT01261611|Secondary|Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5|The assessment was made on a continuous 100-mm horizontal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Mean
2697694|NCT01261611|Secondary|Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5|The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain).|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Mean
2697695|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5|TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms.|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Mean
2697713|NCT01261390|Secondary|Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month|12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
2697696|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5|TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms.|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Mean
2697697|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5|TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms.|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Mean
2697698|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5|TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.|Treatment cycle Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Mean
2697699|NCT01261611|Secondary|Percentage of Treatment Responders Following First Treatment Cycle|"A treatment responder was defined as a patient with >30% improvement in TWSTRS Total score compared to baseline.~TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms."|Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Percentage of participants|||Number
2697700|NCT01261611|Secondary|Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle|The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no symptoms) to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2697701|NCT01261611|Secondary|Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle|The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain).|Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2697702|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle|TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms.|Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2697703|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle|TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms.|Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2697714|NCT01261390|Secondary|E/Em Lateral Ratio (4 Arm) - 12 Month|Endpoint E/Em Lateral Ratio measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mitral velocity ratio (absolute units)||Standard Deviation|Mean
2697704|NCT01261611|Secondary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle|TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms.|Baseline and Week 4|Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2697705|NCT01261611|Primary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle|TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.|Baseline and Week 4|Analysis based on number (n) of subjects in the Intent to Treat (ITT) population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2697706|NCT01261559|Secondary|Number of Participants With Presence of Artifacts Based on CT Image Quality|"CT images acquired will be reviewed for the presence of artifacts that might be attributed to the displacement device or to the presence of the breast tissue.~To evaluate for artifacts, the exam will be qualitatively reviewed by a board certified radiologist for imaging artifacts, such as streak artifact. It will be noted on a per participant basis whether any imaging artifacts are identified."|two months||||Participants|||Count of Participants
2697707|NCT01261559|Secondary|CT Image Noise|"To evaluate image noise, mean of the Standard deviation (SD) of the pixel values, measured in Hounsfield units (HU), will be measured in Picture Archiving and Communication System (PACS) using a region of interest (ROI) measuring 90-110 mm^2 in size drawn over each of these body regions: hepatic dome, spleen, renal cortex, retroperitoneal fat, subcutaneous fat, paraspinal muscles, and if present, breast tissue, avoiding vascular structures in each case. SD for ROI measuring 90-110 mm^2 in size will also be drawn over the aorta and inferior vena cava (IVC), remote from contrast mixing artifact, and over medullary bone of the spine.~HU is the linear scale by which digital image data are displayed in PACS and reflect relative attenuation compared to distilled water at a standard temperature and pressure (STP) (defined as 0 HU) and of pure air at STP (defined as -1000HU). Within a drawn ROI, the PACS will give the mean attenuation (in HU) and the standard deviation of HU (reflecting"|two months|In some cases, a reliable measurement of noise could not be measured on the location. For example, if the breast was not included on the CT, breast noise could not be measured (12 controls and 21 Chrysalis). Too little retroperitoneal or subcutaneous fat was present to draw the relevant ROI in 1 control and 1 Chrysalis subject, respectively.|||Hounsfield units||Standard Deviation|Mean
2697708|NCT01261559|Primary|Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)|Relative skin entrance dose at the breast (group mean of patient's average skin entrance dose at TLDs 2-4) divided by skin entrance dose at the inframammary TLD (TLD 1) in %. For each patient, doses at TLDs 2-4 were averaged, and then the group mean of this was divided by the group mean at the inframammary TLD, then multiplied by 100 to get % dose. A relative dose of 20% means that the skin entrance dose at the breast was 20% of the skin entrance dose at the inframammary fold.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour||||percentage of dose||Standard Deviation|Mean
2697709|NCT01261559|Primary|Skin Entrance Radiation Dose During Computed Tomography (CT)|Skin entrance radiation doses will be measured with Thermoluminescent dosimeters (TLDs) affixed to the subject's chest and breast during CT of the abdomen. TLD #1 is at the inframammary fold, serving as internal control for each subject. Three additional TLDs (#2-4) are affixed to the subject's breast at 3 pre-ascribed locations. The same is done for the right and left breasts (8 TLDs total). TLDs will then be submitted to Landaeur for measurement.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour||||mrad||Standard Deviation|Mean
2697710|NCT01261507|Secondary|False Positive Decisions of Radiologists|This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level.|1 day||||percentage of marks not on cancers||Standard Error|Mean
2697711|NCT01261507|Secondary|Sensitivity and Specificity|Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected.|1 day||||Percentage of cases||Standard Error|Mean
2697712|NCT01261507|Primary|Localized Receiver Operating Characteristic (LROC) Comparison|"The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as noise cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement."|1 day|All participants were included for calculation of A-LROC and Sensitivity-Specificity. All radiographs were interpreted both without and with software assistance|||unitless|Participants|Standard Error|Mean
2697715|NCT01261390|Secondary|Pulmonary Vascular Resistance (4 Arm) - 12 Month|Endpoint Pulmonary Vascular Resistance measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||Wood units||Standard Deviation|Mean
2697716|NCT01261390|Secondary|Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month|Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
2697717|NCT01261390|Secondary|Right Ventricular Fractional Area Change (4 Arm) - 12 Month|Endpoint Right Ventricular Fractional Area Change measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage change in RV area||Standard Deviation|Mean
2697718|NCT01261390|Secondary|Ejection Fraction (4 Arm) - 12 Month|Endpoint Ejection Fraction measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage ejection fraction||Standard Deviation|Mean
2697719|NCT01261390|Secondary|End-Diastolic Volume (4 Arm) - 12 Month|Endpoint End-Diastolic Volume measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm||Standard Deviation|Mean
2697720|NCT01261390|Secondary|Left Atrial Volume Index (4 Arm) - 12 Month|Endpoint Left Atrial Volume Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||m/m2||Standard Deviation|Mean
2697721|NCT01261390|Secondary|Left Ventricular Mass Index (4 Arm) - 12 Month|Endpoint Left Ventricular Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||g/m2||Standard Deviation|Mean
2697722|NCT01261390|Secondary|Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline|Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
2697723|NCT01261390|Secondary|E/Em Lateral Ratio (4 Arm) - Baseline|Baseline E/Em Lateral Ratio measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mitral velocity ratio (absolute units)||Standard Deviation|Mean
2697724|NCT01261390|Secondary|Pulmonary Vascular Resistance (4 Arm) - Baseline|Baseline Pulmonary Vascular Resistance measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||Wood units||Standard Deviation|Mean
2697725|NCT01261390|Secondary|Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline|Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
2697726|NCT01261390|Secondary|Right Ventricular Fractional Area Change (4 Arm) - Baseline|Baseline RV Fractional Area Change measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage change in RV area||Standard Deviation|Mean
2697727|NCT01261390|Secondary|Ejection Fraction (4 Arm) - Baseline|Baseline Ejection Fraction measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percent ejection fraction||Standard Deviation|Mean
2697782|NCT01260883|Secondary|Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery|total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac and 12 received placebo infusion after surgery|||mg/kg||Standard Deviation|Mean
2697728|NCT01261390|Secondary|End-Diastolic Volume (4 Arm) - Baseline|Baseline End-Diastolic Volume measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm||Standard Deviation|Mean
2697729|NCT01261390|Secondary|Left Atrial (LA) Volume Index (4 Arm) - Baseline|Baseline Left Atrial Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||m/m2||Standard Deviation|Mean
2697730|NCT01261390|Secondary|Left Ventricular (LV) Mass Index (4 Arm) - Baseline|Baseline Left Ventricular Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||g/m2||Standard Deviation|Mean
2697731|NCT01261390|Secondary|Change in Augmentation Index at Months 6 and 12 (4 Arms)|Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percent of central pulse pressure||Standard Deviation|Mean
2697732|NCT01261390|Secondary|Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms)|Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||m/s||Standard Deviation|Mean
2697733|NCT01261390|Secondary|Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm)|Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||AU/mL||Standard Deviation|Mean
2697734|NCT01261390|Secondary|Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm)|Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||ug/mg||Standard Deviation|Mean
2697735|NCT01261390|Secondary|Change in Urine Microalbumin at Months 6 and 12 (4 Arm)|Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||ug/mL||Standard Deviation|Mean
2697736|NCT01261390|Secondary|Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm)|Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mL/min/1.73m^2||Standard Deviation|Mean
2697737|NCT01261390|Secondary|Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm)|Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||pg/dL||Standard Deviation|Mean
2697738|NCT01261390|Secondary|Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm)|Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||uIU/mL||Standard Deviation|Mean
2697739|NCT01261390|Secondary|Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm)|Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage glycosylated hemoglobin||Standard Deviation|Mean
2697740|NCT01261390|Secondary|Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm)|Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mg/dL||Standard Deviation|Mean
2697741|NCT01261390|Secondary|Change in Lipid Panel at 6 and 12 Months (4 Arm)|Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Lipid measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mg/dL||Standard Deviation|Mean
2697742|NCT01261390|Secondary|Change in C-Reactive Protein at Months 6 and 12 (4 Arm)|C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mg/L||Standard Deviation|Mean
2697743|NCT01261390|Secondary|Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm)|The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
2697744|NCT01261390|Secondary|Change in Patient Health Questionnaire (PHQ8) (4 Arm)|The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
2697745|NCT01261390|Secondary|Change in Epworth Sleepiness Scale (ESS) (4 Arm)|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
2697746|NCT01261390|Secondary|Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm)|The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
2697747|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months.|6-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
2697748|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
2697749|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis.|6-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
2697783|NCT01260883|Primary|Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery|noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants|24 hours after surgery|52 infants of the 77 total were aged 6-18 months. 15 were excluded for abnormal laboratory values at screening or for lack of access to draw blood samples. 25 received drug, 12 placebo.Doses 0.5 or 1 mg/kg reported together since no difference in analysis.|||min||Standard Deviation|Mean
2697750|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
2697751|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
2697752|NCT01261390|Primary|Difference in CPAP Adherence by Active Treatment Arm|Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization.|6-months|Intent to treat population for those assigned to Active PAP (all individuals who were randomized to one of the two PAP arms).|||hours/night||Standard Deviation|Mean
2697753|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint.|||mmHg||Standard Deviation|Mean
2697754|NCT01261325|Secondary|Time to the Tenth Type I Seizure During the Treatment Period||12 week Treatment Period||||days||95% Confidence Interval|Median
2697755|NCT01261325|Secondary|Time to the Fifth Type I Seizure During the Treatment Period||12 week Treatment Period||||days||95% Confidence Interval|Median
2697756|NCT01261325|Secondary|Time to the First Type I Seizure During the Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||days||95% Confidence Interval|Median
2697757|NCT01261325|Secondary|All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||number of seizures/ 28-day||Inter-Quartile Range|Median
2697758|NCT01261325|Secondary|Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||percentage of subjects|||Number
2697759|NCT01261325|Secondary|Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||percentage of subjects|||Number
2697760|NCT01261325|Secondary|Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||percentage of change||Inter-Quartile Range|Median
2697761|NCT01261325|Primary|50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.|Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||Percentage of subjects|||Number
2697762|NCT01261325|Primary|Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary endpoint: United States of America (FDA)|12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||Percentage of reduction|||Number
2697763|NCT01261247|Other Pre-specified|Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)||At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years|||||||
2697764|NCT01261247|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).|Every 6 months for up to 2 years|Patients who achieved a confirmed response were included in this analysis.|||months||95% Confidence Interval|Median
2697784|NCT01260883|Primary|Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants|population-based analysis of ketorolac stereo-isomers|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo. Drug handling not different at doses of 0.5 or 1 mg/kg so reported together.|||ml||Standard Error|Mean
2697765|NCT01261247|Secondary|Median Progression-free Survival Time|The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) > 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, > 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.|Every 6 months for up to 2 years||||months||95% Confidence Interval|Median
2697766|NCT01261247|Secondary|Median Overall Survival Time|The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Every 6 months for up to 2 years||||months||95% Confidence Interval|Median
2697767|NCT01261247|Primary|Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status|"The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with success for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients."|Every 28 days for up to 2 years|Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|||proportion of CR or PR patients||95% Confidence Interval|Number
2697768|NCT01261052|Secondary|Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.|Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment|||mg/dl||Standard Deviation|Mean
2697769|NCT01261052|Primary|Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity|The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment|||mg/dl||Standard Deviation|Mean
2697770|NCT01261000|Primary|Effect of Pegvisomant on Colon Tissue p53 Expression|Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant|8 weeks||||ng/mL||Standard Deviation|Mean
2697771|NCT01260948|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2697772|NCT01260948|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2697773|NCT01260922|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2697774|NCT01260922|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2697775|NCT01260896|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2697776|NCT01260896|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2697777|NCT01260896|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2697778|NCT01260896|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2697779|NCT01260896|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2697780|NCT01260896|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2697781|NCT01260883|Secondary|Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants|continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo|||per cent time of 12 hours||Standard Deviation|Mean
2697806|NCT01260688|Secondary|Treatment Discontinuation Due to Adverse Events (AEs)|Treatment discontinuation due to Adverse Events|Through study completion (median duration on study = 4 cycles)||||participants|||Number
2697789|NCT01260883|Primary|Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants|half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery|24 hours after surgery|total infants enrolled was 77; 26 were excluded before study procedures began. Of 51 infants completing the study, 8 infants aged 2-6 months received drug.No difference in analysis at doses of 0.5 or 1 mg/kg so reported together.|||min||Standard Error|Mean
2697790|NCT01260883|Primary|Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)|24 hours post surgery|25 infants aged 2-6 months enrolled; 11 excluded for no sampling intravenous access. 8 infants received drug, 6 received placebo. No difference in analysis of doses of 0.5 or 1 mg/kg so reported together.|||ml||Standard Deviation|Mean
2697791|NCT01260883|Primary|Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants|24 hours after surgery|infants enrolled but did not complete protocol if abnormal laboratory studies or intravenous catheters were not functioning prior to study drug infusion. Of 77 enrolled, 51 completed study; of the 33 given ketorolac,8 were aged 2-6 months. Doses of 0.5 or 1 mg/kg were handled similarly so reported together.|||ml||Standard Error|Mean
2697792|NCT01260883|Primary|Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery|stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)|24 hours following surgery|of 25 infants aged 2-6 months enrolled, 11 were excluded. 8 received drug, 6 received placebo; this is a subset of the 77 enrolled infants (aged 2-18 months) of whom 51 completed the study. Infants receiving drug at 0.5 or 1 mg/kg were reported together, since no difference in drug handling was seen.|||ml/min||Standard Error|Mean
2697793|NCT01260701|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
2697794|NCT01260701|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to < 1.0 cm. Partial response (PR) is >= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years|Eligible patients who began protocol therapy and were assessed for response.|||percentage of participants||95% Confidence Interval|Number
2697795|NCT01260701|Primary|Overall Survival (OS)|Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who began protocol therapy.|||months||95% Confidence Interval|Median
2697796|NCT01260701|Secondary|Progression Free Survival (PFS)|PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|Eligible patients who began protocol therapy|||months||95% Confidence Interval|Median
2697797|NCT01260688|Secondary|Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire|Scale is measured on a range from 0 (worst quality of life) to 156 (best quality of life).|Up to 16 weeks|Some participants (overall and post-baseline) did not complete the questionnaire or failed to answer more than 7 questions and could not be included in the analysis (a summary score could not be calculated).|||units on a scale||Full Range|Median
2697798|NCT01260688|Secondary|Overall Response Rate|Response Rate of Stable Disease and Progressive Disease|Duration of Study (median duration on study = 4 cycles)|Analysis of number of participants who experienced response rates of SD and PD.|||percentage of participants|||Number
2697799|NCT01260688|Secondary|Dose Reductions|The number of participants with dose reductions in each arm|Duration of Study (median duration on study = 4 cycles)|Analysis conducted on the number of participants with dose reductions in each arm of the study.|||Participants|||Count of Participants
2697800|NCT01260688|Secondary|Dose Interruption Due to AEs|The number of participants with dose-interruptions in each arm due to adverse events|Through study completion (median duration on study = 4 cycles)|Analysis was performed on study participants assessing the number of participants with dose-interruptions due to adverse events.|||Participants|||Count of Participants
2697801|NCT01260688|Secondary|Number of Participants With Increased Alkaline Phosphatase BAP|Number of participants with increased alkaline phosphatase BAP|Through study completion (median duration on study = 4 cycles)||||participants|||Number
2697802|NCT01260688|Secondary|Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced|Participants for which beta-C telopeptide was reduced|Through study completion (median duration on study = 4 cycles)|Analysis was done on study participatns for which beta-C telopeptide was reduced.|||Participants|||Count of Participants
2697803|NCT01260688|Secondary|Treatment Related Deaths|Number of treatment related deaths|Through study completion (median duration on study = 4 cycles)|In Arm II (Cediranib alone), 1 patient presented retroperitoneal hemorrhage (Grade 5).|||participants|||Number
2697809|NCT01260688|Secondary|Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale|Present Pain Intensity (PPI) scale. Scale is measured 0-5, where 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain and 5=excruciating pain Participants who were up to completing the assessment (did not decline) and who reported a score >=2 at the end of any cycle are reported.|After every cycle (median duration on study = 4 cycles)|Analysis was performed patients receiving single agent cediranib or combination of cediranib plus dasatinib.|||Participants|||Count of Participants
2697810|NCT01260688|Secondary|Number of Participants With Toxicities|Incidence of toxicities graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0|Up to 30 days after last dose of study drugs||||participants|||Number
2697811|NCT01260688|Primary|12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2)|Progression is defined using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, which includes a compilation of prostate-specific antigen (PSA), bone scan, and CT-scan assessments (Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 months|All patients were included in the analysis for 12-week PFS.|||participants|||Number
2697812|NCT01260662|Secondary|Procedural Recall|After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.|Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||percentage report recall of procedure|||Number
2697813|NCT01260662|Secondary|Respiratory Depression|Continuous capnographic monitoring|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||number of respiratory depression events|||Number
2697814|NCT01260662|Primary|Hypoxia|Pulse oximetry|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||Patients which experienced hypoxia|||Number
2697815|NCT01260662|Primary|Clinical Interventions During Sedation|Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||Clinical interventions performed|||Number
2697816|NCT01260649|Secondary|Number of Participants With Cognitive Side Effects|will compare the incidence of participants with memory deficits between groups, as determined by incidents of clinician reported cognitive adverse events|3 months||||Participants|||Count of Participants
2697817|NCT01260649|Primary|Change in Hamilton Depression Rating Scale - 28|"HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms.~The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms."|baseline, one month||||units on a scale||Standard Deviation|Mean
2697818|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers||After dose on Day 10 of Active Treatment Periods 1 and 2|1 clopidogrel smoker was not evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2697819|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers|Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose.|After dose on Day 10 of Active Treatment Periods 1 and 2|1 Clopidogrel smoker participant was not evaluable for this measure.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2697820|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%|"Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of responders and poor responders following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose."|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.|||% participants with PRI <=50%|||Number
2697821|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235||Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.|||% participants with PRU <=235|||Number
2697822|NCT01260584|Secondary|Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status|"Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of responders and poor responders following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose."|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.|||% vasodilator stimulated phosphoprotein||Standard Error|Least Squares Mean
2698771|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Creatinine|Clinical laboratory assessments for creatinine at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmol/L||Standard Deviation|Mean
2697823|NCT01260584|Secondary|Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status|"Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders~Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of responders and poor responders following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose."|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.|||P2Y12 reaction unit||Standard Error|Least Squares Mean
2697824|NCT01260584|Primary|Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.|IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).|Baseline to day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.|||percentage of device derived inhibition||Standard Error|Least Squares Mean
2697825|NCT01260493|Primary|Satisfaction With Health and Social Care||1 year|||||||
2697826|NCT01260493|Primary|Dependence in Activities of Daily Living|Changes in number of person dependent in one or more daily activity from baseline to follow-up.|1 year||||participants|||Number
2697827|NCT01260493|Primary|Health Care Consumption|Number of hospital days and admission will be analysed|1 year|||||||
2697828|NCT01260467|Secondary|Number of Participants With Adverse Events|This study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.|24 months||||participants|||Number
2697829|NCT01260467|Primary|6 Month Progression-free Survival||24 months|not evaluated due to poor patient accrual||||||
2697830|NCT01260467|Primary|Overall Survival||30 months|not evaluated due to poor patient accrual||||||
2697831|NCT01260454|Secondary|Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change|We counted the number of participants who used any amount of narcotic during the 14 day diary period.|14 days|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.|||participants|||Number
2697832|NCT01260454|Secondary|Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score|Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10.|60 minute period of patch application and subsequent 3 days||||participants|||Number
2697833|NCT01260454|Primary|Pain Score on a Visual Analogue Scale|"Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded 0 for two consecutive days.~The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10)."|14 days after a new infusion site|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.|||Visual Analogue Scale||Standard Deviation|Mean
2697834|NCT01260350|Secondary|Percentage of Participants With Virologic Failure|"The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.~On-treatment virologic failure was defined as:~Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),~Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or~Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)~Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit."|Up to Posttreatment Week 24|Safety Analysis Set|||percentage of participants|||Number
2697835|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.|Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2697836|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Baseline to Week 8|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2697837|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline to Week 6|Safety Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2697838|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.|Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2697839|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Week 8|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2697840|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 6||Week 6|Safety Analysis Set|||percentage of participants|||Number
2697841|NCT01260350|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.|Posttreatment Week 12|Safety Analysis Set|||percentage of participants|||Number
2697842|NCT01260350|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to 12 weeks plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study medication.|||Percentage of participants|||Number
2715735|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4||28 Days|Participants with available data at Week 4.|||percentage of participants|||Number
2697843|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].|||incidence rate ratio||95% Confidence Interval|Number
2697844|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].|||incidence rate ratio||95% Confidence Interval|Number
2697845|NCT01260324|Primary|Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)||01-January-2003 up to 31-December-2007|Participants from the NAION cases population adjudicated by medical record review.|||participants|||Number
2697846|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use|Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697847|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697848|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors|Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.|01-January-2003 up to 31-December-2007|Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697849|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697850|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697851|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697940|NCT01259427|Primary|Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~3 1/2 months (post-treatment)||||units on a scale||Standard Deviation|Mean
2697852|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
2697853|NCT01260311|Other Pre-specified|Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
2697854|NCT01260311|Other Pre-specified|Number of UUI Episodes Per 24 Hours at Week 4 and Week 8|UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
2697855|NCT01260311|Other Pre-specified|Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8|Urgency episodes were defined as micturitions with USS rating of greater than or equal to (>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
2697856|NCT01260311|Other Pre-specified|Number of Micturitions Per 24 Hours at Week 4 and Week 8|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
2697857|NCT01260311|Primary|Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment|Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).|Baseline up to 28 days after last dose|Safety population defined as all participants who received at least one dose of study medication.|||participants|||Number
2697858|NCT01260272|Secondary|Change in High Density Lipoprotein Cholesterol Levels|Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
2697859|NCT01260272|Secondary|Change in Waist Circumference|Raisin versus snacks: change in waist circumference from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||cm||Standard Error|Mean
2697860|NCT01260272|Primary|Percent Change in Body Weight|Raisin versus snacks: percent change in body weight from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
2697861|NCT01260272|Primary|Percent Change in Fasting Glucose Levels|Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||95% Confidence Interval|Median
2697862|NCT01260272|Secondary|Change in Hemoglobin A1c|Raisin versus snacks: change in hemoglobin A1c from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
2697863|NCT01260272|Secondary|Change in Diastolic Blood Pressure|Raisin versus snacks: change in diastolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||mmHg||Standard Error|Mean
2697864|NCT01260272|Secondary|Change in Systolic Blood Pressure|Raisin versus snacks: change in systolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||mmHg||Standard Error|Mean
2697865|NCT01260272|Primary|Percent Change in Postprandial Glucose Levels|Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
2697866|NCT01260194|Secondary|Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer|The HER2 status was determination by using immunohistochemistry (IHC) and confirmatory Fluorescent In Situ Hybridization (FISH) techniques. Only participants with HER2 positivity were allowed to receive study medication.|Baseline|Safety population.|||participants|||Number
2697867|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|The LVEF was measured using Multi Gated Acquisition (MUGA) or echocardiography (echocardiography was preferred), using the same technique throughout for consistency in an individual participant. Baseline LVEF assessments were done within 21 days prior to the start of treatment. Participants with clinically significant change from baseline (that is, absolute drop in LVEF of >=15%, and drop to a value <50%) have been reported.|Baseline, thereafter every 12 weeks (maximum up to 22 months)|Safety population.|||participants|||Number
2697868|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Lab parameters assessed during the study were serum chemistry, biochemistry - serum electrolytes, hematology, 12 lead electrocardiogram, and urinalysis - protein, glucose, blood and other lab tests. Laboratory tests were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 3.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population.|||participants|||Number
2697869|NCT01260194|Secondary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population included all participants who had received at least 1 dose of study drug.|||participants|||Number
2697870|NCT01260194|Secondary|Duration of Response (DR)|"DR was based on RECIST criteria v1.1 and was defined as time from date the CR or PR was first recorded to the date on which PD was first noted. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions and/or appearance of 1 or more new lesions. For the participants with no documented progression after CR or PR, the censored date (the date of death, the last tumor measurement, last date in drug log, or last follow-up) was taken into consideration. The median duration of response with 95% CI was estimated using Kaplan Meier method."|Baseline up to PD or death (maximum up to 22 months)|ITT population. The number of participants analyzed signifies the number of participants analyzed for this outcome measure.|||days||95% Confidence Interval|Median
2697871|NCT01260194|Secondary|Percentage of Participants With Clinical Benefit Response (CBR)|CBR was defined as any response among stable disease (SD) for 6 weeks or longer, CR, or PR as determined by the RECIST v 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to PD or death (maximum up to 22 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2697872|NCT01260194|Secondary|Percentage of Participants With Overall Tumor Response|Overall tumor response was defined as the occurrence of either a confirmed complete response (CR) or a partial response (PR) as best overall response as determined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1 from confirmed radio-graphic evaluations of target and non-target lesions. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<]10 mm); no new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions.|Baseline up to PD or death (maximum up to 22 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2697873|NCT01260194|Secondary|Overall Survival (OS)|"OS was defined as the time from the date of enrollment to the date of the death (from any cause). If no death was observed, censored observations were taken into account in the analysis. The censoring date was the last date of last tumor measurement, last date in drug log, or last follow-up. The median overall survival time with 95% CI was estimated using Kaplan Meier method."|Baseline up to death (maximum up to 22 months)|ITT population.|||days||95% Confidence Interval|Median
2697941|NCT01259427|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|~3 months (post-treatment)||||units on a scale||Standard Deviation|Mean
2697942|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy.|4-month follow-up|Two SIP subjects had missing data for this variable.|||percentage of time in bed asleep||95% Confidence Interval|Mean
2697874|NCT01260194|Primary|Median Progression Free Survival (PFS)|"The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of last tumor measurement, last date of study drug treatment, or last follow-up. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method."|Baseline up to PD or death (maximum up to 22 months)|ITT population.|||days||95% Confidence Interval|Median
2697875|NCT01260181|Secondary|Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator|The response duration was defined as the time of initial response (complete response (CR) /partial response (PR) whichever is first recorded) until documented disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])|The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment.|||weeks||95% Confidence Interval|Median
2697876|NCT01260181|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population|Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.|Screening (21 days prior to Day 1)|The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment.|||percentage of participants|||Number
2697877|NCT01260181|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to 5 years|The safety population was identical to the ITT population, which included all participants enrolled in the study.|||percentage of participants|||Number
2697878|NCT01260181|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Baseline up to 5 years|The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment.|||weeks||95% Confidence Interval|Median
2697879|NCT01260181|Secondary|Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1|Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.|Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])|The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment.|||weeks||95% Confidence Interval|Median
2697880|NCT01260181|Primary|Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1|Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])|The ITT population was defined as all subjects who are enrolled to the treatment phase of the study, regardless if they completed treatment.|||percentage of participants||95% Confidence Interval|Number
2697881|NCT01260142|Secondary|Relative Bioavailability of Fospropofol and Propofol|The PK parameters for propofol from propofol injectable emulsion were used as the reference formulation. Because propofol is a metabolite of fospropofol, all calculations were conducted after correcting for the different molecular weights of these formulations. Molecular weights of 332.24 (288.24 for free base) and 178.27 were used for fospropofol disodium and propofol injectable emulsion, respectively. The propofol parameters were adjusted as appropriate as discussed above and natural log transformed prior to comparison. Relative bioavailability of propofol from fospropofol disodium (E2083) to propofol from propofol injectable emulsion is calculated as (AUC(FP) x Total Dose of Propofol/AUC(P) x Total Dose of E2083) x Molecular fraction, where AUC(FP) is AUC(0-t) or AUC(0-inf) of propofol from E2083, AUC(P) is AUC(0-t) or AUC(0-inf) of propofol from propofol injectable emulsion and molecular fraction is molecular weight of propofol (178.27)/E2083 (332.24).|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ng x hr/mL||Standard Deviation|Mean
2697943|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy|End of 4-week intervention|Two SIP subjects had missing data for this variable.|||percentage of time in bed spent asleep||95% Confidence Interval|Mean
2715736|NCT01130597|Primary|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment||56 days||||percentage of participants|||Number
2697882|NCT01260142|Secondary|Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale|PD effects were determined from continuous BIS score recordings and from clinical assessment of sedation using the MOAA/S scale. The MOAA/S scale was used to rate the level of alertness/sedation from a score of 0 (does not respond to painful stimulus) to 5 (alert) in the category of responsiveness, with 5 being the MOAA/S value for a fully awake adult. Time to sedation was defined as the time from the first dose of study medication to the first two consecutive MOAA/S scores less than or equal to 4. Fully awake status was reached at the first of 3 consecutive MOAA/S scores of 5 measured every 2 minutes after study drug administration. The MOAA/S scale was described by the Emax model.|Days 1, and 7-14 (2 minutes prior to study drug administration and every 2 minutes thereafter for 20 minutes or until the subject reached Fully Alert status, whichever was later).|PD Analysis Set|||Scores on a scale||Standard Deviation|Mean
2697883|NCT01260142|Secondary|Maximal Sedative Effect Using the Bispectral Index (BIS) Score|Pharmacodynamic (PD) effects were obtained from continuous BIS score recordings obtained throughout the study and from clinical assessment of sedation using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The BIS measurements continued until the participant was fully recovered in the opinion of the investigator or until the PD effect measure returned to baseline. The BIS score varied between 100 (associated with being fully awake) and 0 (associated with a flat line on the electroencephalogram (EEG)). The BIS Index was described by the maximal effect (Emax) model.|Days 1, and 7-14 (BIS measurements were to continue until the subject was fully recovered in the opinion of the investigator or until the PD effect measures returned to baseline measures)|PD analysis set included all participants who had sufficient PD data to derive at least one PD assessment.|||Scores on a scale||Standard Deviation|Mean
2697884|NCT01260142|Primary|Maximum Drug Plasma Concentration of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug/mL||Standard Deviation|Mean
2697885|NCT01260142|Primary|Maximum Drug Plasma Concentration (Cmax) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug/mL||Standard Deviation|Mean
2697886|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to Cmax, log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug.h/L||Standard Deviation|Mean
2697887|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to maximum observed plasma concentration (Cmax), log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug.h/L||Standard Deviation|Mean
2697888|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol|An A-line and V-line were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of propofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC(0-t) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug.h/L||Standard Deviation|Mean
2697920|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment|"The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often). The total score ranges from 0 to 72."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a scale||Standard Deviation|Mean
2700662|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:~- Effective Orifice Area (EOA)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||cm^2||Standard Deviation|Mean
2697889|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))|AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC from time 0 to time t (AUC(0-t)) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|Pharmacokinetic (PK) Analysis Set is the group of participants who have sufficient pharmacokinetic data to derive at least one PK parameter.|||ug.h/L||Standard Deviation|Mean
2697890|NCT01259856|Secondary|Number of Participants With Major Cardiovascular Events After Therapy||4 years||||Participants|||Count of Participants
2697891|NCT01259856|Secondary|Number of Participants With Progression of Disease or Death|"Survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy~To estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) by capturing the rate of progression to a more advanced myeloid malignancy."|4 years||||Participants|||Count of Participants
2697892|NCT01259856|Secondary|Allele Burden|The impact of PEGASYS on JAK2 will be measured by the allele burden; hematopoietic cell clonality will be measured by whether patients with clonal disease return to polyclonal; bone marrow histopathology will be measured by going from abnormal to normal; cytogenetic abnormalities will be measured by seeing if the cytogenetics go from abnormal to normal.To compare the impact of therapy on JAK2-V617F (JAK2), CALR, hematopoietic cell clonality in platelets and granulocytes in females, bone marrow histopathology, and cytogenetic abnormalities.|4 years|data not collected||||||
2697893|NCT01259856|Secondary|JAK2 Allele Burden|To compare the impact of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) on key biomarkers of the disease(s) by measuring the JAK2 allele burden.|4 years|data not collected||||||
2697894|NCT01259856|Secondary|Change in the Total Symptom Score (TSS)|Change in the Total Symptom Score which assessed improvement in disease symptoms measured by the change in TSS from the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) instrument being used in this study from baseline to 12 months. This 19 item instrument includes the previously validated 9 item brief fatigue inventory (BFI), symptoms related to splenomegaly, inactivity, cough, night sweats, pruritus, bone pains, fevers, weight loss, and an overall quality of life assessment. Each item is scored from 0-10 with full scale from 0-190, with higher scores mean worse symptoms.|baseline and 12 months||||score on a scale||Full Range|Mean
2697895|NCT01259856|Secondary|Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events|Number of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).|4 years||||Participants|||Count of Participants
2697896|NCT01259856|Primary|Number of Participants With Partial Remission (PR)|Number of participants with Partial Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Partial Remission means decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.|12 months|there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV|||Participants|||Count of Participants
2697897|NCT01259856|Primary|Number of Participants With Complete Remission (CR)|Number of participants with Complete Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Complete remission means no evidence of disease.|12 months|there were 82 participants in PEGASYS arm 39 with ET and 43 with PV, 86 in Hydroxyurea arm 42 with ET and 44 with PV|||Participants|||Count of Participants
2697898|NCT01259726|Secondary|Time to First CDI Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.|Baseline (Day 1) up to Week 6|ITT-S population|||days||Full Range|Median
2697899|NCT01259726|Secondary|Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools|Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.|Baseline (Day 1) up to Week 6|ITT-S population.|||Participants|||Number
2697900|NCT01259726|Secondary|Number of Participants With Use of Antibacterial Treatment for CDI|"Any antibacterial medication used after Day 1 for which the investigator selected the indication antibacterial for C. difficile infection."|Baseline (Day 1) up to Week 6|ITT-S population.|||Participants|||Number
2697901|NCT01259726|Secondary|Number of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.|Baseline (Day 1) up to Week 6|ITT-S population.|||Participants|||Number
2697902|NCT01259726|Primary|Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3||After study drug administration period (14 days) through Week 6|ITT-S population.|||Participants|||Number
2697903|NCT01259726|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.|Baseline up to 7 days after the last dose of study drug (up to Week 3)|Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Number
2697904|NCT01259713|Secondary|Percentage of Participants With Complete Remission at the End of Remission Induction|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
2697905|NCT01259713|Secondary|Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||days||Inter-Quartile Range|Median
2697906|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
2697907|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
2697908|NCT01259713|Secondary|Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
2697909|NCT01259713|Secondary|Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB.|Time to diagnosis of proven or probable IFIs is presented as the median (Q1,Q3) days to diagnosis of those participants who experienced a proven or probable IFI. Median was not reached if < 50% of participants had an event; Q1 was not reached if < 25% of participants had an event; Q3 was not reached if < 75% of participants had an event.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||days||Inter-Quartile Range|Median
2697910|NCT01259713|Secondary|Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
2697911|NCT01259713|Secondary|Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
2697912|NCT01259713|Primary|Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)|"Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment.~The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy."|During remission-induction chemotherapy (average 7 weeks)|Intent-to-Treat (ITT) Analysis Set: participants in the safety analysis set who had no major violations of entrance criteria.|||percentage of participants|||Number
2697913|NCT01259596|Secondary|Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13|Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
2697914|NCT01259596|Secondary|Insomnia Severity Index (ISI)|self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes|week 13||||units on a scale||95% Confidence Interval|Mean
2697915|NCT01259596|Secondary|Short Form (36) Health Survey (SF-36) to Week 13|physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.|week 13||||units on a scale||95% Confidence Interval|Mean
2697916|NCT01259596|Secondary|Pepper Center Tool for Disability (PCT-D)|self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.|week 13||||units on a scale||95% Confidence Interval|Mean
2697917|NCT01259596|Secondary|Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks|self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
2697918|NCT01259596|Primary|Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13|interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
2700702|NCT01240785|Secondary|Neonate Transfer to Intensive Care Unit Per Arm||0-5 days after delivery||||participants|||Number
2697921|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment|"CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3. The total score combined from all the 26 items ranges from 0 to 88."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a scale||Standard Deviation|Mean
2697922|NCT01259492|Secondary|Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|"CGI-S assesses the patient's current illness state. CGI-S consists of 7 ratings that range from 1 = normal, not at all ill , 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients"|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.|||Participants|||Number
2697923|NCT01259492|Secondary|Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|"On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is no change, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = Very much improved to 7 =Very much worse. Improvement on the CGI-I scale is defined as a visit rating of 1 very much improved or 2 much improved on the CGI-I scale."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.|||participants|||Number
2697924|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment|"The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient's work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more impaired a patient's work, social life, family life is."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a Scale||Standard Deviation|Mean
2697925|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment|The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a Scale||Standard Deviation|Mean
2697926|NCT01259492|Secondary|Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)|"CGI-S assesses the patient's current illness state. CGI-S consists of 7 ratings that range from 1 = normal, not at all ill , 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients"|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2; Patients with CGI-S assessment both at Baseline 1 and Period 2 was included.|||number of participants|||Number
2697927|NCT01259492|Secondary|Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)|"CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change from baseline, 5 = minimally worse, 6 = much worse 7 = very much worse"|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2 Patients with CGI-I assessment both at Baseline 1 and Period 2 was included.|||number of participants|||Number
2697938|NCT01259427|Primary|Sense of Belonging Instrument (Belonging)|The Sense of Belonging Instrument was used to measure perceived belongingness. The measure includes two subscales: the psychological experience of belonging (SOBI-P) and antecedents that foster belonging (SOBI-A). An average of the sum of the items in each subscale were used to calculate the total score for that subscale. The total score of the SOBI-P ranges from 18 to 72, with higher scores indicating less experienced belonging. The total score of the SOBI-A ranges from 14-56 with higher score indicating greater antecedents that foster belonging.|~3 1/2 months (post-treatment)||||units on a scale||Standard Deviation|Mean
2697939|NCT01259427|Primary|General Self-Efficacy Scale|The General Self-efficacy measure was used to measure of self-efficacy. A total score was calculated by averaging the responses on the items (range=1 to 5), with higher scores indicating greater self-efficacy.|~3 1/2 months (post-treatment)||||unit on a scale||Standard Deviation|Mean
2697928|NCT01259492|Secondary|Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)|"DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often)."|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2|||Score on Scale||Standard Deviation|Mean
2697929|NCT01259492|Secondary|Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1|"On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is no change, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = Very much improved to 7 =Very much worse. Improvement on the CGI-I scale is defined as a visit rating of 1 very much improved or 2 much improved on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N * 100."|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Evaluable patients with both baseline and post-baseline (end of week 9) assessments were included.|||Percentage of Patients|||Number
2697930|NCT01259492|Primary|Percentage of Participants With Treatment Failures During Period 3|Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) >= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) > - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54|Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. One patient in Ritalin LA 80mg did not have post baseline 2 measurements and was not included in the categories under without imputation.|||Percentage of participants|||Number
2697931|NCT01259492|Primary|Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment|SDS, a 5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores >5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.|||Units on a Scale||Standard Deviation|Mean
2697932|NCT01259492|Primary|Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (Never) to 4 (Very often). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 - DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) <= - 30%."|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.|||Units on a Scale||Standard Deviation|Mean
2697933|NCT01259466|Secondary|Percent Weight Change|% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100|Post-treatment (12 weeks)||||Percent weight change||Standard Deviation|Mean
2697934|NCT01259466|Primary|Number of Participants With Verified Smoking Cessation (Abstinence)|Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)|Post-treatment (12-weeks)||||participants|||Number
2697935|NCT01259440|Primary|Treatment Adherence|Nightly CPAP adherence measured over the two-month period .|2 months||||hours/night||Standard Deviation|Mean
2697936|NCT01259427|Secondary|Social Engagement/Withdrawal|The total score of the Social Engagement/Withdrawal subscale of the Social Functioning Scale was used to measure social engagement. The total score ranges from 0 to 15 with higher scores indicating greater social engagement.|~3 1/2 months (post-treatment)||||unit on a scale||Standard Deviation|Mean
2697937|NCT01259427|Secondary|Quality of Life|The Satisfaction with Life in General item from the Brief Quality of Life Scale was used to assess self-reported life satisfaction. The item is rated on a 7-point scale that ranges from terrible to delighted (range=1 to 7), with greater scores indicating more satisfaction.|~3 1/2 months (post-treatment)||||units on a scale||Standard Deviation|Mean
2697944|NCT01259388|Secondary|Change in Expanded Disability Status Scale Score|The Expanded Disability Status Scale (EDSS) is an ordinal scale ranging from 0 to 10 used to assess disability in multiple sclerosis (MS). A score of 0 denotes no neurological impairments and no neurological exam abnormalities, while a score of 10 denotes death due to MS. The EDSS is derived from subscales called Functional System Scales at the lower range of the EDSS, and from ambulatory impairments and overall functional impairment at higher ranges of the scale. The Functional System scores (Vision, Brainstem, Pyramidal, Sensory, Cerebellar, Cognitive, Bladder and Bowel) are used to generate the EDSS based on pre-specified rules that determine the overall EDSS score.|2 years|Due to this being a crossover study design, each participant's data was evaluated for each phase of the trial (Li treatment and observation). Only subjects who completed both years (and thus both phases) of the study were included.|||Units on a scale||Inter-Quartile Range|Median
2697945|NCT01259388|Secondary|Total Relapses|Total number of relapses which occurred during the Li-treatment and observation study phases.|2 years|Due to this being a crossover study design, each participant's data was evaluated for each phase of the trial (Li treatment and observation). Only subjects who completed both years (and thus both phases) of the study were included.|||relapses|||Number
2697946|NCT01259388|Primary|Rate of Change in Brain Parenchymal Fraction|Paired comparison of change in brain parenchymal fraction during Lithium treatment and during observation period|2 years|Due to this being a crossover study design, each participant's data was evaluated for each phase of the trial (Li treatment and observation). Only subjects who completed both years (and thus both phases) of the study were included.|||percentage of change in brain volume||Standard Error|Mean
2697947|NCT01259375|Secondary|Differential Response to Amurbicin Among Certain Histologic Subtypes of Sarcoma.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|48 months||||participants|||Number
2697948|NCT01259375|Secondary|Quality of Response With Radiographic Evaluation Using Both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi Criteria.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Exploratory CT evaluations according to Choi response criteria will be also performed and correlated with RECIST response.|48 months|This exploratory objective was not assessed.||||||
2697949|NCT01259375|Secondary|Overall Survival|This variable reviews the percentage of Overall Survival at 24 months and presents the percentage of participants who survived at 2 years.|two years||||percentage of participants||95% Confidence Interval|Number
2697950|NCT01259375|Secondary|Number of Participants With Serious Adverse Events||4 months|One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response, but was evaluable for safety and toxicity.|||participants who experienced an SAE|||Number
2697951|NCT01259375|Primary|Progression Free Survival|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1) for target lesions and assessed by CT; time elapsed between treatment initiation and tumor progression or death. In target lesions, progression is defined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In non-target lesions, progression is defined via RECIST v 1.1 as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|six months||||percentage of pt with 6 mnth PFS||95% Confidence Interval|Number
2697952|NCT01259375|Primary|Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|48 months|One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response.|||percentage of pt with a partial response||95% Confidence Interval|Number
2697953|NCT01259297|Secondary|Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen|The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date.|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||Participants|||Number
2697954|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Mean sitting diastolic blood pressure (msDBP) is the average of 2 sitting DBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.|||mmHg||Standard Error|Least Squares Mean
2697955|NCT01259297|Secondary|Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|"The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following:~End-stage renal disease [ESRD] requiring dialysis or transplantation~Doubling of serum creatinine and reaching an eGFR < 45 ml/min/1.73 m^2."|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||participants|||Number
2699356|NCT01250730|Primary|Apparent Volume of Distribution (Vz/F) of Crizotinib|"Vz/F of crizotinib is obtained from a Dose / (AUCinf *kel).~Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||Liter||Standard Deviation|Geometric Mean
2697956|NCT01259297|Secondary|Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)).~Part II of SAGE included 2 dimensions:~Normal if the scores of all SAGE questions is 0 (i.e., No difficulty)~Mobility Only if scores of both SAGE questions 11 and 12 are 0"|End of study (209 days [median])|Full Analysis Set. Number of patients with all SAGE questions non-missing for the specific visit are included in this population. Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn.|||percentage of participants|||Number
2697957|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||participants|||Number
2697958|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Mean sitting systolic blood pressure (msSBP) is the average of 2 sitting SBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.|||mmHg||Standard Error|Least Squares Mean
2697959|NCT01259297|Secondary|Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions:~Community Cognition (maximum of scores of questions 1 to 6);~Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10);~Mobility (maximum of scores of questions 11 and 12);.~Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension's total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities."|Baseline, End of study (209 days [median])|Full Analysis Set: Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn. Patients who completed both baseline and post-baseline SAGE questionnaires (Part II) were included in this analysis.|||units on a scale||Standard Deviation|Mean
2697960|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||participants|||Number
2697961|NCT01259284|Primary|Incidences of Atrial Fibrillation During First 4 Days After Lung Resection|New onset of sustained (15 min or >) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium.|Baseline to 4 days post surgery|Analysis was to be per protocol. There is no analysis due to an inadequate number of enrolled participants in study which resulted in early termination.||||||
2697962|NCT01259245|Secondary|FEV1% Pred|Pred FEV1 percent predicted normal values;measured using spirometry|6 months post-intervention|Intention to treat|||percentage of FEV1 predicted||Standard Deviation|Mean
2697963|NCT01259245|Secondary|FEV1|Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry|6 months post-intervention|Intention to treat analysis|||liters||Standard Deviation|Mean
2697964|NCT01259245|Secondary|FVC|Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry|6 months post intervention|Intention to treat analysis|||liters||Standard Deviation|Mean
2697965|NCT01259245|Secondary|6 MWT in Meters|The 6 minute walking test ( 6MWT) was conducted according to protocol recommended by American Thoracic Society (ATS) guidelines to measure functional exercise capacity.This test measured the self paced distance in meters that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.|6 months post-intervention|Intention to treat analysis|||meters||Standard Deviation|Mean
2697966|NCT01259245|Primary|SGRQ HKC Total|SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
2697967|NCT01259245|Primary|SGRQ HKC-Impact|SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|intention to treat|||units on a scale||Standard Deviation|Mean
2697969|NCT01259245|Primary|SGRQ HKC-Symptoms|SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
2697970|NCT01259245|Primary|Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)|The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients' overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.|Change in SEMSOB at 6 months post-intervention|Intention to treat|||units on a scale||Standard Deviation|Mean
2697971|NCT01259245|Primary|Self Efficacy :COPD Self Efficacy Scale (CSES)|"34 item questionnaire consisting of likert scale with 5 responses ranging from 1 indicating  not at all confident to 5 indicating  very confident with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as not at all confident and 1 as very confident. The validated Chinese version of CSES was also used"|Change in CSES at 6 months post-intervention|Intention to treat was used in the analysis|||rating score of 0.2 to 1||Standard Deviation|Mean
2697972|NCT01259115|Secondary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments consisted of monitoring and recording medical history, physical examinations, vital signs (including temperature, heart rate, blood pressure and respiratory rate), reports of adverse experiences, and laboratory abnormalities (including electrocardiogram [ECG]).|The first day of study drug administration to 30 days after the last dose of study drug.|Safety Population: Safety analyses were performed on all subjects who received at least 1 dose of study drug and for whom at least 1 postdose safety observation was recorded.|||participants|||Number
2697973|NCT01259115|Primary|Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
2697974|NCT01259115|Primary|AUCinf of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||||||
2697975|NCT01259115|Primary|AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
2697976|NCT01259115|Primary|Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
2697977|NCT01259115|Primary|AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
2698815|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1|Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Vss values.|||liters (L)||Standard Error|Mean
2697978|NCT01259115|Primary|AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
2697979|NCT01259115|Primary|Cmax of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
2697980|NCT01259115|Primary|AUCinf of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
2697981|NCT01259115|Secondary|CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test.|As part of subject screening, Erythromycin Breath Tests (EBT) were done on all potential subjects (enrolled population). CYP 3A4 inhibition was calculated by taking the difference of the baseline 14C erythromycin metabolism, subtracting the 14C erythromycin metabolism during ketoconazole treatment, dividing this difference by the baseline 14C erythromycin metabolism, and multiplying by 100 to express results in the form of percent inhibition. CYP3A4 inhibition was only done when subjects were on ketoconazole.|One time at screening and one time during ketoconazole treatment|Enrolled Population: All subjects who participated in the study. CYP3A4 Inhibition was only done when subjects were on Ketoconazole.|||Percentage of participants||Standard Deviation|Mean
2697982|NCT01259115|Primary|AUCt of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
2697983|NCT01259115|Primary|Cmax of Buprenorphine With and Without Ketoconazole.|"Cmax (maximum observed plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral tablets twice daily,~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
2697984|NCT01259115|Primary|AUCinf of Buprenorphine With and Without Ketoconazole.|"AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.|||pg /mL•h||Standard Deviation|Mean
2697996|NCT01259089|Secondary|Overall Survival Among Patients With Acquired Resistance With T790M Mutations (Phase II)|Overall Survival (OS) will be measured from treatment initiation until death due to any cause for patients with acquired resistance with T790M mutations in the phase II portion of the study.|From the time of first treatment with AUY922 to death, followed for up to 2 years|No data was collected or analyzed for this outcome measure. There is no data to report. IND was withdrawn before the studies anticipated termination date.||||||
2699357|NCT01250730|Primary|Apparent Oral Clearance (CL/F) of Crizotinib|CL/F of crizotinib is obtained from a Dose per AUCinf.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||liter per hour||Standard Deviation|Geometric Mean
2697985|NCT01259115|Primary|AUCt of Buprenorphine With and Without Ketoconazole.|"AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or Ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.|||pg/mL*h||Standard Deviation|Mean
2697986|NCT01259102|Secondary|Period 2: Tmax0-7d.|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||hour||Standard Error|Mean
2697987|NCT01259102|Secondary|Period 1: Tmax0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||hour||Standard Error|Mean
2697988|NCT01259102|Secondary|Period 2: Cmax0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
2697989|NCT01259102|Secondary|Period 1: Cmax0-7|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
2697990|NCT01259102|Secondary|Period 2: AUC0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
2697991|NCT01259102|Secondary|Period 1: AUC0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
2697992|NCT01259102|Primary|Period 2: Cmax0-3d|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
2697993|NCT01259102|Primary|Period 1: Cmax0-3d|"Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
2697994|NCT01259102|Primary|Period 2: AUC0-3d.|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d.~AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
2697995|NCT01259102|Primary|Period 1: AUC0-3d|Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)].|0 to 3 days (72 hours)|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
2697997|NCT01259089|Secondary|Overall Survival (Phase II)|Overall survival (OS) is defined as the time from treatment initiation until death due to any cause.|From the time of first treatment with AUY922 to death, followed up to 2 years post treatment|25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal.|||Months||95% Confidence Interval|Median
2697998|NCT01259089|Secondary|Progression-free Survival (Phase II)|Median Progression Free Survival (PFS) will be calculated from time of treatment initiation until the first documentation of progressive disease. Patients will be considered to have progressive disease when CT scan or MRI show at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the time of first treatment with AUY922 to disease progression for up to 2 years post treatment|25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal.|||Months||95% Confidence Interval|Median
2697999|NCT01259089|Secondary|Incidence of Reported Adverse Events in Phase I|"Adverse events will be collected weekly for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment, for up to 2 years and half years|Most frequent adverse events for patients treated with 25 to 55mg/m2 dose of AUY9222.|||participants|||Number
2698000|NCT01259089|Secondary|Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)|"To characterize the toxicity profile for the combination of erlotinib and AUY922.~Toxicity data will be collected every week for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment for up to 2 years and half years|Toxicity collected from all patients treated at the MTD of 70mg/m2 AUY922. 6 patients in phase I and 19 patients in phase II were treated at this dose.|||participants|||Number
2698001|NCT01259089|Primary|Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922|"Overall response rate (ORR) will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI:~Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR), defined as >=30% decrease in the sum of the longest diameter of target lesions.~Stable Disease (SD) defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.~Progressive Disease (PD) defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions"|At 8 weeks from treatment initiation|All patients that were treated at the MTD dose of 70mg/m2 AUG922 IV were evaluable for this outcome measure (This includes patients treated in cohort 5 of phase I and all patients treated in phase II of the study)|||Participants|||Count of Participants
2698002|NCT01259089|Primary|Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I)|"To determine the maximally tolerated dose (MTD), and recommended phase II dose of AUY922 when given in combination with erlotinib for patients with acquired resistance to erlotinib. (Phase I)~Escalation of dose will be in a 3+3 design. If no dose limiting toxicities (DLTs) are seen in 3 patients enrolled at that dose level, then dose will be escalated to the next dose level and the next 3 patients will be enrolled at that dose. Alternatively, if 1 DLT is seen in 3 patients at that dose level, 3 more patients will be added at that same dose level. If 1 DLT is seen in 6 patients at that dose level, MTD will be determined to be at that dose. If more than 1 DLT is seen at that dose level, then the prior lower dose level will be the considered the MTD.~DLT is defined as any of the following related to the investigational agent: Death and grade 3 and 4 specific hematological and non-hematological toxicities defined in the protocol."|During the first 4 weeks of treatment for each patient.||||Number of DLTs seen|||Number
2698003|NCT01259063|Secondary|Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation|In all pre-treatment specimens and analysis of post treatment specimens when available.|1 year|Inability for sequencing due to inadequate amount of tissue||||||
2698004|NCT01259063|Secondary|Survival of Patients Treated|With Everolimus in combination with intravesical gemcitabine. Overall survival following start of therapy will be estimated using Kaplan-Meier methods.|1 year||||% of pts with CR who relapsed in a year||95% Confidence Interval|Number
2698005|NCT01259063|Secondary|Complete Response (CR) Rate|Complete Response (CR) is defined as no evidence of disease (by cytology and cystoscopy). Partial Response is defined as negative cystoscopy and positive cytology. Progression is defined as the development of invasion or metastasis. If the participant develops a recurrence, they will be considered having failed treatment. Participants will also be considered having failed treatment if there is no response to treatment after two cycles.|1 year||||Participants|||Count of Participants
2698006|NCT01259063|Primary|Phase I - Maximum Tolerated Dose (MTD)|of Everolimus given in conjunction with intravesical gemcitabine|8 weeks|14 participants enrolled in Phase I|||mg daily of everolimus|||Number
2698007|NCT01259063|Primary|Phase II - Patients Who Are Free of Disease at 1 Year|following start of therapy.|1 year|19 participants were evaluable for Phase II.|||percentage of pts disease free at 1 year||95% Confidence Interval|Number
2698008|NCT01259063|Primary|Phase I - Dose-limiting Toxicity (DLT)|Everolimus (mg) given in conjunction with intravesical gemcitabine|8 weeks|14 of the 33 participants were enrolled in the Phase I portion of the protocol|||DLT|||Number
2698009|NCT01259024|Secondary|To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|1 participant was enrolled, analyzed was 0.||||||
2698010|NCT01259024|Primary|Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|||||||
2698011|NCT01259024|Primary|Determine Efficacy (Based on Whether the Study is Positive or Negative) of the Embolization With the LC Bead in Treatment of HCC With Imaging Outcomes Using Modified RECIST and EASL Criteria.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|1 patient was enrolled in the study, but was withdrawn by the PI due to inability to obtain CMS reimbursement. The patient was treated off protocol and therefore there are no study results to be analyzed.||||||
2698012|NCT01259024|Primary|To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|One participant was enrolled on this IDE and was treated on protocol for 14 weeks. After being made aware that CMS would not provide reimbursement, the PI decided to withdraw the patient and continued to treat off protocol.||||||
2698013|NCT01259011|Secondary|Change Over Time: Post-traumatic Distress Symptom Score|The Post-Traumatic Symptoms Scale-10 (PTSS-10) was used to assess the presence and intensity of PTSD symptoms during the preceding 7 days. This self-report scale consists of 10 statements that specifically mention symptoms related to PTSD criteria (e.g., sleep problems, nightmares, tension in the body, irritation, startle, etc.) rated on a 7-point Likert scale from 1 (Never/Rare) to 7 (Very often/Always). A total score (range 10 - 70) of > 35 is associated with a high probability that the person meets the diagnostic criteria for PTSD.|2 weeks and 3 and 6 months after patient death||||units on a scale||Standard Deviation|Mean
2698014|NCT01259011|Secondary|Change Over Time: Hospital Anxiety and Depression Scale Scores|Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.|2 Weeks, and at 3 and 6 months post death||||units on a scale||Standard Deviation|Mean
2698015|NCT01259011|Primary|Dyad Congruence|patient and surrogate congruence on the goals of care|2, 6, 12 months|patients on dialysis and their surrogates|||percentage of congruent dyads|||Number
2698016|NCT01258998|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity data will be summarized by frequency tables. The association between both type and severity of toxicity and the treatment groups will be evaluated.|Up to 30 days|||||||
2698017|NCT01258998|Secondary|Change in Biomarker Levels of Interest (Akt, pAKT, and Apoptosis [Annexin-V])|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment|||||||
2698018|NCT01258998|Secondary|Change in Chemokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment|||||||
2698019|NCT01258998|Secondary|Change in Cytokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment|||||||
2698020|NCT01258998|Secondary|Overall Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 30 days|||||||
2698021|NCT01258998|Secondary|Duration of Response|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days|||||||
2698022|NCT01258998|Secondary|Progression-free Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days|||||||
2698023|NCT01258998|Primary|Objective Response Rate (ORR)|Objective response rate. Logistic regression utilized to assess the effect of patient demographic factors on OR.|4 months|Based on intent-to-treat analysis.|||participants|||Number
2698858|NCT01253304|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||hours||Full Range|Median
2698024|NCT01258985|Secondary|Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.|From Week 0, to week 24 or to week 52||||units on a scale||95% Confidence Interval|Mean
2698025|NCT01258985|Secondary|Outcome Expectation Scale|The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.|Week 0||||units on a scale||Standard Deviation|Mean
2698026|NCT01258985|Secondary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
2698027|NCT01258985|Secondary|Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
2698028|NCT01258985|Secondary|Change in Arthritis Self-Efficacy Scale|The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
2698029|NCT01258985|Secondary|Change in Beck II Depression Inventory|Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
2698030|NCT01258985|Secondary|Change in Patient Global VAS|Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
2698031|NCT01258985|Secondary|Change in 20 Meter Walk Test|the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability|From Week 0, to Week 12, or to week 24, or to week 52||||seconds||95% Confidence Interval|Mean
2698032|NCT01258985|Secondary|Change in 6 Minute Walk|The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.|From Week 0, to Week 12, or to week 24, or to week 52||||meters||95% Confidence Interval|Mean
2698033|NCT01258985|Secondary|Change in Medical Outcomes Short Form-36 PCS|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
2698034|NCT01258985|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks|The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.|From Week 0 to Week 12||||units on a scale||95% Confidence Interval|Mean
2698035|NCT01258855|Other Pre-specified|1-year Overall Survival Rate|Estimated using the product-limit method of Kaplan and Meier.|Until Death from any cause, up to 1 year||||percentage of participants||95% Confidence Interval|Number
2698036|NCT01258855|Secondary|Progression-free Survival for Patients With Low VEGF Levels|"Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median baseline measure for VEGF were used as the cut point for low vs high VEGF groups."|Up to 5 years||||months||95% Confidence Interval|Median
2698037|NCT01258855|Secondary|Progression-free Survival for Patients With High Vascular Endothelial Growth Factor (VEGF) Levels|"Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median baseline measure for VEGF were used as the cut point for low vs high VEGF groups."|Up to 5 years||||months||95% Confidence Interval|Median
2698038|NCT01258855|Secondary|Count of Participants With Adverse Events|Count of the number of participants with grade 3 & 4 adverse events attributed to treatment agents. Events are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 5 years||||participants|||Number
2698039|NCT01258855|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (RR) = CR + PR.|Up to 5 years||||percentage of participants|||Number
2698040|NCT01258855|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until Death from any cause, up to 5 years||||months||95% Confidence Interval|Median
2701460|NCT01234649|Secondary|Insulinogenic Index (IGI) /HOMA-IR|IGI/HOMA-IR, a measure of early insulin response corrected by fasting insulin resistance, in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||index||Standard Deviation|Mean
2698041|NCT01258855|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The time from the date of randomization until date of progression, death, or recurrence, assessed up to 5 years||||months||95% Confidence Interval|Median
2698042|NCT01258803|Secondary|Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698043|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698044|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698045|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698046|NCT01258803|Secondary|Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698047|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698048|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698237|NCT01257581|Secondary|Hand Held Dynamometry (HHD) Lower Z-score|The HHD lower z-scores are means of z-scores for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Z-score||95% Confidence Interval|Mean
2698049|NCT01258803|Primary|Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
2698050|NCT01258790|Primary|Yale Global Tic Severity Scale|The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.|1 week||||units on a scale (0 - 50)||Standard Deviation|Mean
2698051|NCT01258738|Secondary|Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points|PASS is defined as a symptom state that the participants consider acceptable.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698052|NCT01258738|Secondary|Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points|"The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are Improved - less pain, No change, and Worse - more pain. If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from Not at all important to Very important'."|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698053|NCT01258738|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104|The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698054|NCT01258738|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points|"The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, I tire easily) are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, I feel fit) a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by Yes, that is true (scored 1) to No, that is not true (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698055|NCT01258738|Secondary|Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent overall work impairment due to health problem:~Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698056|NCT01258738|Secondary|Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698057|NCT01258738|Secondary|Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698058|NCT01258738|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698059|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points|"The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual's ability levels given their AS and their job. Each question is assigned a score of 1 for a response of True and 0 for a response of Not True. All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698060|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698061|NCT01258738|Secondary|Change From Baseline in HADS Anxiety Score at Time Points|This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698062|NCT01258738|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points|This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698063|NCT01258738|Secondary|Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698064|NCT01258738|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698065|NCT01258738|Secondary|Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
2698066|NCT01258738|Secondary|Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||mm||Standard Error|Mean
2698067|NCT01258738|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||mm/hr||Standard Error|Mean
2698068|NCT01258738|Secondary|Change From Baseline in C-reactive Protein (CRP) Concentration Time Points|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||mg/L||Standard Error|Mean
2698069|NCT01258738|Secondary|Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698070|NCT01258738|Secondary|Mean Change From Baseline in Dactylitis Score at Time Points|Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698071|NCT01258738|Secondary|Mean Change From Baseline in Number of Tender Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Number of joints||Standard Error|Mean
2698072|NCT01258738|Secondary|Mean Change From Baseline in Number of Swollen Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Number of joints||Standard Error|Mean
2698073|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score|ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases|||Units on a scale||Standard Error|Mean
2698074|NCT01258738|Secondary|Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.|||units on a scale||Standard Error|Mean
2698075|NCT01258738|Secondary|Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points|The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.|||units on a scale||Standard Error|Mean
2698076|NCT01258738|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.|||units on a scale||Standard Error|Mean
2698077|NCT01258738|Secondary|Mean Change From Baseline in Occiput-to-wall Test at Time Points|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||cm||Standard Error|Mean
2698078|NCT01258738|Secondary|Change From Baseline in Chest Expansion at Time Points|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||cm||Standard Error|Mean
2698079|NCT01258738|Secondary|Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698080|NCT01258738|Secondary|Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698081|NCT01258738|Secondary|Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698082|NCT01258738|Secondary|Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2701461|NCT01234649|Secondary|Matsuda Insulin Sensitivity Index Derived From OGTT|OGTT- derived insulin sensitivity index in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||index||Standard Deviation|Mean
2698083|NCT01258738|Secondary|Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698084|NCT01258738|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698085|NCT01258738|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points|The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698086|NCT01258738|Secondary|Percentage of Participants With BASDAI 20 at Time Points|Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698087|NCT01258738|Secondary|Percentage of Participants With BASDAI 50 at Time Points|Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698088|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698089|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698090|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698109|NCT01258738|Secondary|Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points|The Investigator estimated the participant's overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
2698091|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Discomfort at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698092|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698093|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698094|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698095|NCT01258738|Secondary|Mean Change From Baseline in BASFI Putting on Socks at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698096|NCT01258738|Secondary|Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698097|NCT01258738|Secondary|Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698098|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698110|NCT01258738|Secondary|Time to ASAS Partial Remission|The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||percentage of participants||95% Confidence Interval|Number
2698099|NCT01258738|Secondary|Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698100|NCT01258738|Secondary|Mean Change From Baseline in BASFI Reaching up High at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698101|NCT01258738|Secondary|Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698102|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698103|NCT01258738|Secondary|Mean Change From Baseline in BASFI Bending Forward at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698104|NCT01258738|Secondary|Mean Change From Baseline in BASFI Full Day Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698105|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698106|NCT01258738|Secondary|Changes From Baseline in VAS Score for Total Back Pain at Time Points|"The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for No pain  to 100 mm for Most Severe Pain."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
2698107|NCT01258738|Secondary|Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points|"The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for No pain  to 100 mm for Most Severe Pain."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
2698108|NCT01258738|Secondary|Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points|Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
2698124|NCT01258660|Primary|Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)|The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment||||nmol·week/L||95% Confidence Interval|Geometric Mean
2698111|NCT01258738|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Time Points|Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698112|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points|ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
2698113|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 5/6 Response at Time Points|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698114|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 20 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698115|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 40 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
2698116|NCT01258738|Primary|Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 12|Modified intent-to-treat (mITT) population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for axial spondyloarthritis (AxSpA). Missing data were imputed through last observation carried forward (LOCF) approach.|||Percentage of participants|||Number
2698117|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid|baseline, and up to 24 weeks of treatment||||µmol/L||Standard Deviation|Mean
2698118|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin|baseline and week 24||||µmol/L||Standard Deviation|Mean
2698119|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 6|Folate metabolite pattern in plasma at cycle 6|week 24||||nmol/L||Standard Deviation|Mean
2698120|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 3|Folate metabolite pattern in plasma at cycle 3|week 12||||nmol/L||Standard Deviation|Mean
2698121|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Baseline|Folate metabolite pattern in plasma at baseline|pre-treatment|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||Standard Deviation|Mean
2698122|NCT01258660|Primary|Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)|Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)|from week 24 to week 44||||proportion of participants|||Number
2698123|NCT01258660|Primary|Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment||||nmol·week/L||95% Confidence Interval|Geometric Mean
2716046|NCT01128179|Secondary|Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)||12 weeks|PP|||percentage of excretion of phosphate||Standard Error|Least Squares Mean
2698125|NCT01258608|Secondary|Serum Concentration of Mapatumumab|Blood samples were collected for determination of serum mapatumumab concentration at the indicated time points. NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time points.|Day1 pre-dose(Cycle 1,2,4,5,6,8,9,10,12,14,16,17,18,20,22,24,26,28,30,32,34);end of infusion (Cycle 1);Day8 pre-dose(Cycle 1);Day15 pre-dose (Cycle 1,2);Day21(Cycle 2,4,6,8,9,12,14,16,18,20,22,24,26,28,30,32,34);Cycle 99(end of treatment) (21-day cycles)|As Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Nanograms per milliliter||Standard Deviation|Mean
2698126|NCT01258608|Secondary|Change From Baseline in Weight|Weight was obtained on Day 1 of each cycle. Baseline is the last assessment prior to first dose. Change from Baseline is the value at indicated time point minus the value at Baseline. NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline and Day 1 of Cycles 2 to 75 (each cycle of 21 days)|As Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Kilograms||Standard Deviation|Mean
2698127|NCT01258608|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was obtained on Day 1 of each cycle. Baseline is the last assessment prior to first dose.Change from Baseline is the value at indicated time point minus the value at Baseline. NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline and Day 1 of Cycles 2 to 75 (each cycle of 21 days)|As Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Breaths per minute||Standard Deviation|Mean
2698128|NCT01258608|Secondary|Change From Baseline in Temperature|Temperature was obtained on Day 1 of each cycle. Baseline is the last assessment prior to first dose. Change from Baseline is the value at indicated time point minus the value at Baseline. NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline and Day 1 of Cycles 2 to 75 (each cycle of 21 days)|As Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Celsius||Standard Deviation|Mean
2698129|NCT01258608|Secondary|Change From Baseline in Heart Rate|Heart rate was obtained on Day 1 of each cycle. Baseline is the last assessment prior to first dose. Change from Baseline is the value at indicated time point minus the value at Baseline. NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline and Day 1 of Cycles 2 to 75 (each cycle of 21 days)|As Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2698130|NCT01258608|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were obtained on Day 1 of each cycle. Baseline is the last assessment prior to first dose. Change from Baseline is the value at indicated time point minus the value at Baseline. NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline and Day 1 of Cycles 2 to 75 (each cycle of 21 days)|As Treated Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2698131|NCT01258608|Secondary|Number of Participants With Anti-mapatumumab Antibodies|Blood samples were collected for the assessment of serum antibodies. The presence of anti-mapatumumab antibodies was assessed using a validated electrochemiluminescent immunoassay. The assay incorporated a tiered testing approach which used screening and confirmation steps. The anti-drug antibody (ADA) confirmed positive participants were separated into transient or persistent antibody positives. Persistent positive refers to positive immunogenic response at 2 or more assessments or at the final assessment. Transient positive refers to positive immunogenic response at only 1 assessment and negative at the final assessment.|Randomization to maximum of 24.1 months|As-Treated Population. Only participants with an available immunogenicity assay were analyzed.|||Participants|||Count of Participants
2698132|NCT01258608|Secondary|Number of Participants With Worst Toxicity Grade-hematology Parameters|Blood samples were collected for assessment of the following hematology parameters: activated partial thromboplastin time (APTT), hemoglobin, international normalized ratio (INR), lymphocytes, neutrophils, platelets and white blood cells (WBC). Laboratory toxicities were graded based on the NCI-CTCAE version 4.0. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or non-invasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life -threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life -threatening consequences; urgent intervention indicated. Number of participants with worst toxicity grades for any abnormalities observed in any hematology parameters during the study is presented.|Enrolment to maximum of 52.9 months|As-Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2698133|NCT01258608|Secondary|Number of Participants With Worst Toxicity Grade-chemistry Parameters|Blood samples were collected for the evaluation of following chemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), amylase, bilirubin, gamma glutamyl transferase (GGT), calcium, potassium, magnesium, albumin, sodium and creatinine. Laboratory toxicities were graded based on the NCI-CTCAE version 4.0. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or non-invasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life -threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life -threatening consequences; urgent intervention indicated. Number of participants with worst toxicity grades for any abnormalities observed in any chemistry parameters during the study is presented.|Enrolment to maximum of 52.9 months|As-Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2698382|NCT01256567|Secondary|Clearance (Cl) of Ramucirumab|Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable clearance data at the specified time points.|||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
2698134|NCT01258608|Secondary|Number of Participants With Severe AEs|An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. Severity of AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or non-invasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life -threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life -threatening consequences; urgent intervention indicated. Grade 5 represents death related to AE. Severe AE is defined as AEs classified by investigator as severe (causing inability to carry out usual activities), life threatening or fatal using NCI-CTCAE Version 4.0 grading.|Start of study treatment to maximum of 52.9 months|As-Treated Population|||Participants|||Count of Participants
2698135|NCT01258608|Secondary|Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. An SAE is an adverse event resulting in any of the following outcomes: death, life-threatening, inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or other medically important events that may jeopardize the participant or may require intervention to prevent one of the other outcomes mentioned before. A treatment-emergent AE is an AE that emerged during treatment, having been absent pre-treatment, or worsened relative to the pre-treatment state. As-Treated Population comprised of participants who received at least part of 1 dose of study agent analyzed according to the treatment that they actually received.|Start of study treatment to maximum of 52.9 months|As-Treated Population|||Participants|||Count of Participants
2698136|NCT01258608|Secondary|Duration of Response-BICR Assessment|Duration of response is defined as time from first PR or CR to radiologic disease progression; in responders only. CR: Disappearance of intratumoral arterial enhancement in all target lesions. PR: At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the Baseline sum of the diameters of target lesions. Progressive disease (PD): An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started.|Randomization to maximum of 24.1 months|mITT Population. Only responders were included in the analysis.|||Days||Full Range|Median
2698137|NCT01258608|Secondary|Time to Response-BICR Assessment|Time to response is defined as time from randomization to first partial response or complete response in responders only. Complete Response (CR): Disappearance of intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions|Randomization to maximum of 24.1 months|mITT Population. Only responders were included in the analysis.|||Days||Full Range|Median
2698138|NCT01258608|Secondary|Percentage of Participants With Disease Control-Investigator Assessment|Disease control rate is the percentage of participants with complete response+partial response+stable disease according to mRECIST criteria for hepatocellular carcinoma to investigator assessments. The percentage of participants with disease control is presented along with 95% confidence interval.|Randomization to maximum of 52.9 months|mITT Population. Only those participants with available assessment for best response were analyzed|||Percentage of participants||95% Confidence Interval|Number
2698139|NCT01258608|Secondary|Percentage of Participants With Disease Control-BICR Assessment|Disease control rate is the percentage of participants with complete response+partial response+stable disease according to mRECIST criteria for hepatocellular carcinoma. The end point was based on BICR assessment of imaging scans. The percentage of participants with disease control is presented along with 95% confidence interval.|Randomization to maximum of 24.1 months|mITT Population. Only those participants who had their BICR scans read and having available assessment for best response were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2698140|NCT01258608|Secondary|Percentage of Participants With Objective Response-Investigator Assessment|Objective response rate is defined as the percentage of participants with complete response+partial response according to mRECIST criteria for hepatocellular carcinoma to investigator assessments. The percentage of participants with objective response is reported along with 95% confidence interval.|Randomization to maximum of 52.9 months|mITT Population. Only those participants with available assessment for best response were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2698141|NCT01258608|Secondary|Percentage of Participants With Objective Response-BICR Assessment|Objective response rate is defined as the percentage of participants with complete response+partial response according to mRECIST criteria for hepatocellular carcinoma using BICR assessment of imaging scans. The percentage of participants with objective response is reported along with 95% confidence interval.|Randomization to maximum of 24.1 months|mITT Population. Only those participants who had their BICR scans read and having available assessment for best response were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2698142|NCT01258608|Secondary|Progression Free Survival-Investigator Assessment|Progression free survival is defined as time from randomization to radiologic disease progression or death from any cause. The analysis was performed using Kaplan Meier methods based on application of mRECIST for hepatocellular carcinoma to investigator assessments. The median progression free survival is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.|Randomization to maximum of 52.9 months|mITT Population|||Months||90% Confidence Interval|Median
2698143|NCT01258608|Secondary|Progression Free Survival-BICR Assessment|Progression free survival is defined as time from randomization to radiologic disease progression or death from any cause. The analysis was performed using Kaplan Meier methods using BICR assessment of imaging scans. The median progression free survival is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.|Randomization to maximum of 24.1 months|mITT Population. Only those participants who had their BICR scans read were included in the analysis.|||Months||90% Confidence Interval|Median
2716047|NCT01128179|Secondary|Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)||12 weeks|PP|||pg/ml||Standard Error|Least Squares Mean
2698144|NCT01258608|Secondary|Median Overall Survival|Overall survival is defined as time from randomization to death from any cause. The analysis was performed using Kaplan Meier methods. The median overall survival is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.|Randomization to maximum of 52.9 months|mITT Population|||Months||90% Confidence Interval|Median
2698145|NCT01258608|Secondary|Time to Progression-Investigator Assessment|Time to progression is defined as the time from randomization to radiologic disease progression. The primary analysis was performed using Kaplan Meier methods based on application of mRECIST for hepatocellular carcinoma to investigator assessments. The median time to progression is reported with one-sided 90% confidence interval. NA indicates upper limit was not measurable as one-sided confidence interval is presented.|Randomization to maximum of 52.9 months|mITT Population|||Months||90% Confidence Interval|Median
2698146|NCT01258608|Primary|Time to Progression-Blinded Independent Central Review (BICR) Assessment|Time to progression is defined as the time from randomization to radiologic disease progression based on blinded independent review (BICR) of imaging scans using modified Response Evaluation Criteria in Solid Tumors assessment (mRECIST) for hepatocellular carcinoma. The primary analysis was performed using Kaplan Meier methods. The median time to progression is reported with one-sided 90% confidence interval. Analysis was performed on the modified Intent to Treat (mITT) Population which comprised of all randomized participants who received at least part of 1 dose of study agent (mapatumumab/placebo and/or sorafenib) with participants analyzed according to the groups to which they were randomized. NA indicates upper limit was not measurable as one-sided confidence interval is presented.|Randomization to maximum of 24.1 months|mITT Population. Only those participants who had their BICR scans read were included in the analysis.|||Months||90% Confidence Interval|Median
2698147|NCT01258595|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.|||Participants|||Number
2698148|NCT01258595|Primary|Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post vaccination|Seroprotection was assessed in the full analysis set population.|||Percentage of Participants|||Number
2698149|NCT01258595|Primary|Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|"Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.~Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method."|Day 0 and Day 28 post-vaccination|Seroconversion to the vaccine antigens was assessed in the full analysis set population.|||Percentage of Participants|||Number
2698150|NCT01258595|Primary|Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 Post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
2698151|NCT01258595|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
2698152|NCT01258582|Primary|Acceptability of the HIV Test|The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).|Assess on day subject enrolled into the study|Intent to treat analysis|||proportion of participants||95% Confidence Interval|Number
2698153|NCT01258504|Primary|Cmax of Bosentan||after first dose, at steady-state and during SJW||||ng/ml||95% Confidence Interval|Geometric Mean
2698154|NCT01258504|Primary|AUC of Bosentan||0-infinity; during dosing interval||||h*ng/ml||95% Confidence Interval|Geometric Mean
2698155|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)|"ESV is the volume of blood remaining in each ventricle at the end of systole.¹~¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population|||Milliliter(s)||Standard Deviation|Mean
2698156|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)|"EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹~¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population|||Milliliter(s)||Standard Deviation|Mean
2698157|NCT01258387|Secondary|Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)|"An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹~Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.²~¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/~²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population|||percent change||Standard Deviation|Mean
2698158|NCT01258387|Primary|Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)|"Safety/ tolerability of single dose; cumulative safety over 6 months~TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment."|6 months|Safety population|||participants|||Number
2698159|NCT01258374|Primary|Geometric Mean of t1/2, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy|Geometric mean of t1/2 of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of t1/2, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.|After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.|HIV-1–infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled|||h||Full Range|Geometric Mean
2698160|NCT01258374|Primary|Geometric Mean of C-max, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.|Geometric mean of C-max of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of C-max, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.|After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.|HIV-1–infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled|||ng/mL||Full Range|Geometric Mean
2698161|NCT01258374|Primary|Geometric Mean of AUC, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.|Geometric mean of AUC0 of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.|After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.|HIV-1–infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled|||ng.h/mL||Full Range|Geometric Mean
2698162|NCT01258374|Primary|Geometric Mean of C-Trough, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.|Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations.|After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.|HIV-1–infected patients, receiving a NRTI-based regimen, naive to RAL, with no evidence of PI mutations by genotype test, and signed informed consent forms. 15 patients ere screened and enrolled|||ng/ml||Full Range|Geometric Mean
2698163|NCT01258348|Secondary|The Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Events module.|Baseline to study completion up to 70 weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2698164|NCT01258348|Secondary|Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)|"LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.~Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.~Cycle 2: predose and end of infusion."|Days 1 to 42 in Cycles 1 and Cycle 2 (6 weeks per cycle)|Participants who received study drug and had sufficient pharmacokinetic (PK) data to calculate AUCalb at the specified time points.|||hour*micrograms per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2698165|NCT01258348|Secondary|Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC)|Time frame: Cycle 1 day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.|Days 1 to 42 in Cycle 1 (6 weeks per cycle)|Participants who received sunitinib and had sufficient pharmacokinetic (PK) data to calculate AUC.|||hour*nanograms per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2698383|NCT01256567|Secondary|Half Life (t 1/2) of Ramucirumab||Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable t1/2 data at the specified time points.|||days||Geometric Coefficient of Variation|Geometric Mean
2698166|NCT01258348|Secondary|Number of Participants With Tumor Responses|Tumor response was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Number of participants with tumor responses = number of participants with complete response (CR) + number of participants with partial response (PR). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Baseline to end of treatment up to 66 weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2698167|NCT01258348|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636|Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.|Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)|Participants who received study drug and had sufficient pharmacokinetic (PK) data to estimate Cmax at the specified time points.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2698168|NCT01258348|Primary|Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.|Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)|All participants who received at least one dose of study drug.|||micrograms per milliliter (μg/mL)|||Number
2698169|NCT01258153|Secondary|Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.|Safety and tolerability will be assessed for the Safety Population (all patients who received the study drug) in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination and lab test.|up to four weeks|All patients receiving the study drug (114)|||Adverse events|||Number
2698170|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|10 days|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment|||Score range 0-5|Participants|Standard Deviation|Mean
2698171|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|1 week|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment|||Score range 0-5|Participants|Standard Deviation|Mean
2698172|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|1 day|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment|||Score range 0-5|Participants|Standard Deviation|Mean
2698173|NCT01258153|Secondary|Percentage of 'Responder' Babies at the End of Treatment Period.|Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline.|baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured|||Responders Rate (% of responders babies)|||Number
2698174|NCT01258153|Primary|Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.|"Efficacy assessment to be measured through baby's day diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration)."|Baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured|||Minutes||Standard Deviation|Mean
2698175|NCT01258101|Secondary|Time to Viral Response|Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported.|Up to Week 48|Standard analysis population includes all randomized participants.|||Days||Standard Deviation|Mean
2698176|NCT01258101|Secondary|Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48|For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
2698191|NCT01258049|Primary|Parasitological Success (PP)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|The Per Protocol (PP) population included the subjects in the MITT population who had received at least 80% of doses up to the time of discharge from the hospital, had evaluable data up to and including Day 28 and had no major protocol violations.|||participants|||Number
2698177|NCT01258101|Secondary|Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48|"Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0."|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
2698178|NCT01258101|Secondary|Mean FSS Scores at Baseline and Weeks 16, 24 and 48|The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
2698179|NCT01258101|Secondary|Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48|Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
2698180|NCT01258101|Secondary|Median Hemoglobin Levels at End of Treatment|Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.|At Week 16 and Week 24|The Safety analysis population was defined to include only participant who received at least one dose of (either) study medication and had at least one post-baseline safety assessment.|||g/L||Inter-Quartile Range|Median
2698181|NCT01258101|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|The Safety analysis population was defined to include only participants who received at least one dose of (either) study medication and had at least one post-baseline assessment.|||Number of Participants|||Number
2698182|NCT01258101|Secondary|Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment|Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2698183|NCT01258101|Secondary|Percentage of Participants With Virological Response at the End of the Treatment|Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2698184|NCT01258101|Primary|Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48|Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.|At Week 24 and Week 48|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2698185|NCT01258101|Primary|Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment|Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.|Up to Week 48 (24 weeks post completion of the treatment)|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2698186|NCT01258049|Secondary|Number of Deaths or Neurological Sequelae at Day 28||28 days after start of treatment||||participants|||Number
2698187|NCT01258049|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities||28 days after start of treatment||||participants|||Number
2698188|NCT01258049|Secondary|Time to Return to Normal Per os Status|Time in hours to return to normal per os status. Normal per os was when the investigator considered the patient to be able to eat and drink normally.|28 days after start of treatment||||hours||Standard Deviation|Mean
2698189|NCT01258049|Secondary|Time to Return to Full Consciousness|"Time in hours to return to full consciousness (Blantyre Coma Scale = 5), if level of consciousness is reduced (Blantyre Coma Scale <5) prior to dosing or within 24hours of first dosing.~For the Blantyre Coma Scale~Total - maximum 5, eye movement - maximum 1, best motor response - maximum 2, best verbal response - maximum 2"|28 days after start of treatment||||hours||Standard Deviation|Mean
2698190|NCT01258049|Secondary|Late Parasitological Failure|o Parasitaemia on any day from Day 7 to Day 28 and tympanic temperature ≤ 38.0°C|28 days after the start of treatment||||participants|||Number
2716048|NCT01128179|Secondary|Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)||12 Weeks|PP|||pg/ml||Standard Error|Least Squares Mean
2698192|NCT01258049|Secondary|Late Clinical Failure|"Signs of severe malaria on any day between Day 4 and Day 28 in the presence of parasitaemia, without previously meeting any of the criteria of early treatment failure~Presence of parasitaemia and tympanic temperature ≥ 38.0°C (or history of fever), on any day between Day 4 and Day 28, without previously meeting any of the criteria of early treatment failure"|28 days after the start of treatment||||participants|||Number
2698193|NCT01258049|Secondary|Early Treatment Failure|"Early treatment failure is indicated by one or more of the following:~Parasite count on Day 2 > Day 0, irrespective of temperature~Parasite count on Day 3 > 0 with tympanic temperature ≥ 38.0°C~Parasite count on Day 3 ≥ 25% of baseline~Administration of rescue antimalarial treatment"|Three days after the start of treatment||||participants|||Number
2698194|NCT01258049|Secondary|Complete Cure Rate|The complete resolution of clinical signs and symptoms, malaria-related laboratory abnormalities, and elimination of asexual parasites by Day 7, with no recurrence up to Day 28 (+/- 2 days), and the 48h parasite count to be < 25% of baseline with no clinical deterioration|28 days after the start of treatment|For some subjects, this endpoint was not evaluable and/or not all data was received.|||participants|||Number
2698195|NCT01258049|Secondary|Fever Clearance Time (FCT)|Time in hours from the initiation of therapy until the disappearance of fever (tympanic temperature < 38.0) that lasted at least 24 hours.|28 days after start of treatment||||hours||Standard Deviation|Mean
2698196|NCT01258049|Secondary|PRR 12 [MITT Population]|The percentage reduction in parasite counts 12 hours after first dose|28 days after start of treatment||||percentage of baseline||Standard Deviation|Mean
2698197|NCT01258049|Secondary|PRR 24 [MITT Population]|The percentage reduction in parasite counts 24 hours after first dose|28 days after start of treatment||||percentage of baseline||Standard Deviation|Mean
2698198|NCT01258049|Secondary|PCT 50 [MITT Population]|Time for parasite counts to fall by 50%|28 days after start of treatment||||hours||Standard Deviation|Mean
2698199|NCT01258049|Secondary|PCT 90 [MITT Population]|Time for parasite counts to fall by 90%|28 days after start of treatment||||hours||Standard Deviation|Mean
2698200|NCT01258049|Secondary|Parasite Clearance Time (PCT) [MITT Population]|Parasite clearance time (PCT). Time in hours from the initiation of therapy until the first of two successive parasite negative smears (zero parasite counts) are obtained|28 days after start of treatment||||hours||Standard Deviation|Mean
2698201|NCT01258049|Primary|Parasitological Success (MITT)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|"The Modified Intention to Treat (MITT) population included all randomised subjects who received at least one dose of study medication and had evaluable parasite counts at 24 hours after first dosing.~7 subjects for ArTiMist and 3 subjects for quinine were excluded due to no baseline or 24 h parasite count"|||participants|||Number
2698202|NCT01257880|Secondary|White Matter Lesions|Presence and severity of white matter lesions on magnetic resonance imaging, taken within 5 years prior to study enrollment. Subjects will not have magnetic resonance imaging performed as part of this study. Films will be requested and an independent neuroradiologist will assess presence of white matter lesions.|Within 5 years prior to enrollment|||||||
2698203|NCT01257880|Secondary|Oxygen Desaturation Index|Measurement of number of times per hour blood oxygen saturation decreases by at least 4% during home sleep study.|Baseline|||||||
2698204|NCT01257880|Primary|Cognitive Function|Cognitive function will be assessed by a battery of performance-based neuropsychological tests.|Baseline|||||||
2698205|NCT01257880|Primary|Sleep Apnea, Number of Participants|An apnea-hypopnea index (AHI) >10 per hour during a home sleep study, defined as at least 5 hours of recorded data on the portable sleep monitor instrument for either the apnea-hypopnea index (AHI) or oxygen desaturation index (ODI) and at least 3 hours for the other index. The scale adopted for assessment of sleep apnea is as follows: AHI < 5, optimal; AHI 5-10, equivocal, participant may have sleep apnea; AHI >10, sleep apnea highly likely.|Following one night of a home sleep study|The analysis was based on per protocol.|||participants|||Number
2698206|NCT01257880|Primary|Platelet Activation|Platelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.|Baseline|||||||
2698207|NCT01257880|Primary|Cerebral Vasomotor Reactivity (VMR)|"The percentage change in basilar artery blood flow velocity from baseline between hypercapnia (increased blood CO2) and hypocapnia (decreased blood CO2), as measured by transcranial Doppler during a single testing period. This is calculated using the following equation:~VMR = 100 x (VelocityHYPERCAPNIA - VelocityHYPOCAPNIA) / VelocityBASELINE"|Baseline||||Percentage change||Standard Deviation|Mean
2698208|NCT01257880|Primary|Embolic Tracks|Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver|Baseline|||||||
2698209|NCT01257802|Secondary|Mean Ovarian Volume.|Mean ovarian volume reflects the preservation of ovarian tissue despite exposure to cyclophosphamide; reduced ovarian size is documented in cyclophosphamide treated patients|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone|||cubic centimeters||Standard Deviation|Mean
2698210|NCT01257802|Secondary|Mean Antral Follicle Count (AFC)|Mean antral follicle count (AFC) is the average number of follicles counted in each of 2 ovaries|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone|||# of ovarian follicles||Standard Deviation|Mean
2698211|NCT01257802|Secondary|Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.|An AMH level of >1 ng/ml and/or an antral follicle count of >4 in either ovary is a strong predictor of residual ovarian function|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone|||Participants|||Count of Participants
2698384|NCT01256567|Secondary|Area Under the Curve (AUC) of Ramucirumab|AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.|Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable AUC data at the specified time points.|||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2698212|NCT01257802|Secondary|Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,|AMH level ≤1.0 predicts onset of menopause within 5 years in normal women|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone|||Participants|||Count of Participants
2698213|NCT01257802|Primary|Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit|AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.|Day 0 to 6-month post-intervention visit|8 subjects are listed in the breakdown of baseline characteristics. Samples were missing from one subject enrolled in the Placebo arm - therefore analysis throughout the majority of the reporting will include only 7 samples instead of 8 in the Placebo arm|||ng/ml||Standard Deviation|Mean
2698214|NCT01257750|Secondary|Corneal Vessel Caliber|Corneal vessel caliber is the measurement of the diameter of the corneal blood vessels. The mean change in the corneal vessel caliber from baseline to 12 week time point is reported below.|12 Weeks||||millimeters||Standard Deviation|Mean
2698215|NCT01257750|Secondary|Corneal Vessel Length|Corneal vessel length is the measurement of the length of the extent of vessels from end to end. The mean change in corneal vessel length from Baseline to 12 Week Time Point is reported below.|12 Weeks||||millimeters||Standard Deviation|Mean
2698216|NCT01257750|Secondary|Corneal Invasion Area|Corneal Invasion area is the measurement of the fraction of the total corneal area that is invaded by blood vessels. The mean Change in Corneal invasion area from baseline to 12 Week Time Point is reported below.|12 Weeks||||millimeters squared||Standard Deviation|Mean
2698217|NCT01257750|Secondary|Corneal Neovascular Area|Corneal neovascular area is the measurement of the area of the cornea where new blood vessels are forming. The mean Change in Corneal Neovascular Area from Baseline to 12 Week Time Point is reported below.|Through 12 weeks of Follow-Up|Mean Change in Corneal Neovascular Area (measuring the area of the corneal vessels) from Baseline to 12 Week Time Point.|||millimeters squared||Standard Deviation|Mean
2698218|NCT01257750|Primary|Intaocular Pressure|Intaocular pressure is the measurement of pressure within the eye. Intaocular pressure was measured throughout the study to assess subjects for ocular adverse events.|12 Weeks||||mmHg||Standard Deviation|Mean
2698219|NCT01257750|Primary|Central Corneal Thickness|Pachymetry was used to measure the central corneal thickness of each study subject. Central corneal thickness was measured throughout the study to assess subjects for ocular adverse events.|12 Weeks|All enrolled patients were analyzed.|||Microns||Standard Deviation|Mean
2698220|NCT01257750|Primary|Mean Arterial Pressure|Mean arterial pressure was measured throughout the study to assess subjects for systemic adverse events..|12 Weeks||||mmHG||Standard Deviation|Mean
2698221|NCT01257750|Primary|Heart Rate|Heart rate through was measured throughout the study to assess subjects for systemic adverse events.|12 Weeks|All enrolled patients were analyzed.|||Beats per Minutes||Standard Deviation|Mean
2698222|NCT01257737|Secondary|Mean California Verbal Learning Test Scores: Short and Long Delay Free Recall, Short and Long Delay Cued Recall, CVLT-II-Learning Slope, and Total Word Recognition Discrimination|The California Verbal Learning Test - Second Edition (CVLT-II) assesses recall and recognition of word lists over several immediate- and delayed-memory trials. In the learning phase, adult participants were presented a list of 16 words (List A; 4 words each in 4 categories [e.g., fruit, toys, etc.]) for 5 trials, but words from the same category were never presented consecutively. An interference list (List B) of 16 different words was then presented for 1 trial. Short-and long-delay recalls for List A, yes/no recognition trials of List A, and a forced-choice recognition trial of List A was also administered. The scores for the learning slope, the short- and long-delay scores and total word recognition discrimination scores were converted to Z-scores by computer software. The CVLT-II Z-score has a mean of 0 and a standard deviation of 1. Negative scores indicate below-average performance.|Baseline, Month 12, Month 24, Month 36, Month 48, and study exit visit (up to 66 months)|Adult participants (age 19-61) with available data; data were not analyzed for the 4 ongoing adult participants in Canada after the cutoff for the clinical study report (29 Oct 2015).|||Z-Score||Standard Deviation|Mean
2698223|NCT01257737|Secondary|Mean California Verbal Learning Test Scores: List A Total 1-5 T-Scores|The California Verbal Learning Test - Second Edition (CVLT-II) assesses recall and recognition of word lists over several immediate- and delayed-memory trials. In the learning phase, adult participants were presented a list of 16 words (List A; 4 words each in 4 categories [e.g., fruit, toys, etc.]) for 5 trials, but words from the same category were never presented consecutively. An interference list (List B) of 16 different words was then presented for 1 trial. Short-and long-delay recalls for List A, yes/no recognition trials of List A, and a forced-choice recognition trial of List A was also administered. The total score for the 5 immediate-recall trials was converted to a T-score. Lower T-scores reflect worse performance.|Baseline, Month 12, Month 24, Month 36, Month 48, and study exit visit (up to 66 months)|Adult participants (age 19-61) with available data; data were not analyzed for the 4 ongoing adult participants in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-Score||Standard Deviation|Mean
2698224|NCT01257737|Secondary|Mean Behavior Rating Inventory of Executive Function (BRIEF) Scores|The Behavior Rating Inventory of Executive Function (BRIEF) is designed to assess executive functioning in children and adolescents ages 5 to 18 years of age. Parents/caregivers answered 86 questions on a 3-point scale (never, sometimes, often). Similar questions were grouped together into 8 scales; these scales were summed to produce 2 index measures and a global executive composite score. Raw scores for the indices/scales and composite score were converted to T-scores with corresponding 90% confidence intervals using computer software. Higher T-scores indicate a higher level of dysfunction.|Baseline, Month 12, Month 24, and study exit visit (up to 66 months)|Participants 5-18 years of age with available data; data were not analyzed for the 1 ongoing pediatric participant in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-Score||Standard Deviation|Mean
2698385|NCT01256567|Secondary|Maximum Concentration (Cmax) of Ramucirumab|Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable Cmax data at the specified time points.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2698225|NCT01257737|Secondary|Mean Child Behavior Checklist (CBCL) Problems Scores|The Child Behavior Checklist (CBCL) is a widely-used method of identifying problem behavior. Two versions of the CBCL were used in this study; the assessment for children 6-18 years of age was used for participants ≥6 years of age, and the assessment for children 1.5-5 years of age was used for those who were at least 5 years old but <6 years of age. Parents/caregivers answered questions (120 and 100 questions, respectively, for the older and younger populations) using a 3-point Likert scale (0= not true; 1= somewhat or sometimes true; 2 =very true or often true). Using a computer program, responses to similar questions were grouped together into 20 domains (e.g., activities, social, school, etc.), and domain response scores were converted to T-scores and percentiles. A mean score of 50 is average, with a standard deviation of 10 points. Higher scores indicate greater problems. The total problems score is the sum of all of the problem items.|Baseline, Month 12, Month 24, and study exit visit (up to 66 months)|Participants 5-18 years of age with available data; data were not analyzed for the 1 ongoing pediatric participant in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-Score||Standard Deviation|Mean
2698226|NCT01257737|Secondary|Mean Wechsler Abbreviated Scale of Intelligence (WASI) Scores|The Wechsler Abbreviated Scale of Intelligence (WASI) was administered to adults and pediatric participants who were at least 6 years of age. It was used to estimate general intellectual ability (IQ) based on the vocabulary and matrix reasoning subtests. The vocabulary subtest included 4 images and 38 verbal items. In the matrix reasoning subtest, the participant viewed 35 incomplete grid patterns and was asked to complete the pattern using responses from 5 possible choices. The number of correct responses for each of the subtests was converted to a T-score using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation (SD) of 10. Raw scores for the 2 subtests were summed, and converted to a standard score (mean of 100 with SD of 15) for the general IQ score for adults and to a T-score for children in accordance with the WASI manual. Higher scores indicate a higher level of intelligence.|Baseline, Month 12, Month 24, Month 36, Month 48, and study exit visit (up to 66 months)|Participants ≥ 6 years of age with available data; data were not analyzed for the 5 ongoing participants in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-score||Standard Deviation|Mean
2698227|NCT01257737|Secondary|Causes of Hyperammonemic Crises|An hyperammonemic crisis (HAC) was defined as clinical symptoms associated with a venous ammonia concentration of ≥100 μmol/L. Peak observed ammonia concentrations during an HAC, precipitating factors, and symptoms recorded as suggestive to hyperammonemia were documented. There can be multiple contributing factors to an hyperammonemic crisis; in some cases several causes were identified.|From the time of informed consent until 7 days after the last dose of study drug, up to 66 months|Participants who experienced hyperammonemic crises|||Number of crises|Hyperammonemic crises||Number
2698228|NCT01257737|Secondary|Number of Hyperammonemic Crises|An hyperammonemic crisis (HAC) was defined as clinical symptoms associated with a venous ammonia concentration of ≥100 μmol/L.|From the time of informed consent until 7 days after the last dose of study drug, up to 66 months|Safety Population: All participants who received any amount of study medication|||Number of crises|||Number
2698229|NCT01257737|Secondary|Mean Normalized Blood Ammonia Levels|Blood samples were collected for the assessment of plasma ammonia concentrations at baseline, at least every 6 months, at all unscheduled visits, and at the end of study participation. Ammonia level data were obtained from different local laboratories and each laboratory may have used a slightly different normal reference range. Therefore, the ammonia level data were normalized to a standard laboratory reference range before performing any analysis of ammonia data.|From baseline through the end of the study, up to 66 months|Participants with available data|||μmol/L||Standard Deviation|Mean
2698230|NCT01257737|Primary|Number of Participants With at Least One Adverse Event|Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). An AE/adverse experience was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. For additional information regarding adverse events, please see the safety section of the record.|From the time of informed consent until 7 days after the last dose of study drug, up to 66 months|Safety Population: All participants who received any amount of study medication|||Participants|||Count of Participants
2698231|NCT01257698|Primary|Duration of Intraocular Gas|Patients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.|Up to 4 weeks||||days||Standard Deviation|Mean
2698232|NCT01257581|Secondary|ATLIS Upper Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percentages of predicted normal strength||95% Confidence Interval|Mean
2698233|NCT01257581|Secondary|Accurate Test of Limb Isometric Strength (ATLIS) Lower Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percentages of predicted normal strength||95% Confidence Interval|Mean
2698234|NCT01257581|Secondary|HHD Upper % Baseline|The HHD % baseline measures are mean percent change for shoulder flexion, elbow extension, elbow flexion, wrist extension, and first dorsal interosseous muscles from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percent change||95% Confidence Interval|Mean
2698235|NCT01257581|Secondary|HHD Upper Z-score|The HHD upper z-scores are means of z-scores for right and left shoulder flexion, elbow extension, elbow flexion, write extension and first dorsal interosseous muscles with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Z-score||95% Confidence Interval|Mean
2698236|NCT01257581|Secondary|HHD Lower % Baseline|HHD % baseline measures are mean percent change for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percent change||95% Confidence Interval|Mean
2698386|NCT01256567|Secondary|Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)|The number of participants with a positive anti-IMC-1121B titer at any point during the study.|Baseline up to data cut off (approximately 48.3 weeks)|All participants with evaluable antibody assessment data.|||participants|||Number
2698238|NCT01257581|Secondary|Lab Abnormal Reports by Treatment Assignment|The safety data is summarized according to treatment arm. Total number of Adverse Events (AEs), AEs that cause study drug withdrawal and abnormal laboratory tests are compared among treatment arms. A lab abnormality was a result that was out of range and considered clinically significant by the site investigator.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Events|||Number
2698239|NCT01257581|Secondary|Dose Adjustments|These events were due to a double-blinded study design.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Number of Events due to Adverse Events|||Number
2698240|NCT01257581|Secondary|Tracheostomy-free Survival|Secondary efficacy will be assessed by analyzing rate of tracheostomy-free survival at nine months.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||proportion of participants||95% Confidence Interval|Number
2698241|NCT01257581|Secondary|Vital Capacity/Pulmonary Function Testing|Secondary efficacy will be assessed by analyzing the change in the Slow Vital Capacity score over nine months. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percentage of predicted normal.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Percentage of predicted max value||95% Confidence Interval|Mean
2698242|NCT01257581|Primary|Change in ALS Functional Rating Scale - Revised (ALSFRS-R)|Primary efficacy will be assessed by analyzing the mean rate of decline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score over nine months. The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||scores on a scale||95% Confidence Interval|Mean
2698243|NCT01257568|Secondary|Occurrence of Stem Migration, Subsidence and Unstable Fixation|Radiographic stability is defined as having the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of great than or equal to 5 mm. Only subsidence was measured at 6 weeks, migration and fixation are analyzed beginning at 1 year postoperative.|6 wks,1,2,3,4,5 yrs|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. The number of hips analyzed for stem subsidence equals the number of cases with a readable AP Femur or Pelvis x-ray.|||Hips|Hips||Number
2698244|NCT01257568|Secondary|Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-op, 6 wk, 1, 2, 3, 4, 5 year|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2698245|NCT01257568|Secondary|Mean SF-12 Scores at Each Visit|The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-op, 6 wk, 1, 2, 3, 4, 5 year|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2698246|NCT01257568|Secondary|Mean Harris Hip Score at Each Visit|"The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor.~90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor"|pre-op, 6 wk, 1, 2, 3, 4, 5 year|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2698247|NCT01257568|Secondary|Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation|Change from preoperative horizontal distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.|6 weeks|The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.|||mm||Inter-Quartile Range|Median
2698248|NCT01257568|Secondary|Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation|Change from preoperative vertical distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.|6 weeks|The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.|||mm||Inter-Quartile Range|Median
2698249|NCT01257568|Secondary|Biomechanical Measurement of Femoral Offset|Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.|6 weeks|The data presented on these 41 hips is likely inaccurate due to issues and variations in data collection.|||mm|Hips|Inter-Quartile Range|Median
2698250|NCT01257568|Primary|Survival Rate of the Rejuvenate Modular Stem/Neck|The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.|5 years postoperative||||Surviving Hips|Hips||Number
2698251|NCT01257542|Secondary|Participants' Global Assessment of Cough: Relief From Cough|"Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question From when you woke up this morning until now, how much better is your cough? where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better."|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
2698859|NCT01253304|Primary|Pharmacokinetics: Maximum Observed Concentration (Cmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2698252|NCT01257542|Secondary|Participants' Global Assessment of Cough: Cough Severity|"Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question  How much have you coughed in the past 6 hours? where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot."|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
2698253|NCT01257542|Secondary|Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|"Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question How much have you coughed in the last hour?, wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement."|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
2698254|NCT01257542|Secondary|Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period|"Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question How much have you coughed in the last hour?, where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement."|Baseline, 1, 2, 3, 4, 5, 6 hour post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
2698255|NCT01257542|Secondary|Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|"Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question How much have you coughed in the last hour?, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement."|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
2698256|NCT01257542|Secondary|Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period|"Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question How much have you coughed in the last hour?, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement."|Baseline, 1, 2, 3, 4, 5, 6 hours post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
2698257|NCT01257542|Primary|Total Cough Count|Total cough count was done by trained assessors using continuous digital video and audio recordings.|Up to 6 hours post-dose|Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Cough counts||Standard Deviation|Mean
2698258|NCT01257503|Secondary|Overall Symptom Severity|Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up|10 days|Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale||Standard Deviation|Mean
2698259|NCT01257503|Secondary|Health Status|Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up|10 days|Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale||Standard Deviation|Mean
2698260|NCT01257503|Secondary|Functional Status|Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.|10 days|Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale||Standard Deviation|Mean
2698261|NCT01257503|Secondary|Change in Non-specific Symptoms|Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale|Participants|Standard Deviation|Mean
2698262|NCT01257503|Primary|Change in Severity of Cold Symptoms|Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after a dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale|Participants|Standard Deviation|Mean
2698263|NCT01257438|Secondary|Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.|Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.|6 months||||% of subjects with successful PLP||95% Confidence Interval|Number
2698264|NCT01257438|Primary|Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.|Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.|30 days|Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.|||% of subjects free from safety events||95% Confidence Interval|Number
2698265|NCT01257438|Primary|Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.|Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.|6 months|Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).|||% of subjects with successful ACPP||95% Confidence Interval|Number
2698266|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||days||95% Confidence Interval|Median
2698267|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||days||95% Confidence Interval|Median
2698268|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||log(ng/mL)||Standard Deviation|Mean
2698269|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Raw Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||ng/mL||Standard Deviation|Mean
2698270|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|85, 87, 113, 141 and 169 days post-dose|95 patients (IM: 47 patients, SC: 48 patients) received a second injection of the study drug.|||log(ng*day/mL)||Standard Deviation|Mean
2698271|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose||||log(ng*day/mL)||Standard Deviation|Mean
2698272|NCT01257425|Primary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).|Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose|Analysed from ITT population.|||log(ng*day/mL)||Standard Deviation|Mean
2698399|NCT01256450|Secondary|Number of Participants With Response to Treatment as Assessed by an NRS Scale|Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||participants|||Number
2698273|NCT01257347|Secondary|Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period|This will be determined by abstracting data from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider simplified the regimen by switching from a short-acting, multi-day dosing medication to a long-acting, once per day medication or switched two medication to a single combination pill. All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.|1 month clinic visit|patient-provider visits|||percentage of patient-clinician visits|||Number
2698274|NCT01257347|Secondary|Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period|This will be determined based on interviewing patients immediately after the 1-month visit using a standardized questionnaire. A research assistant who is blinded to group assignment will ask patients questions that assess whether clinicians counseled them about taking their blood pressure medications during that most recent visit. These questions are adapted from a validated questionnaire that assesses provider communication about blood pressure medications.|1 month clinic visit||||percentage of patient-clinician visits|||Number
2698275|NCT01257347|Secondary|Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only|This will be determined based on abstracting information from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider intensified the blood pressure regimen (added or increased dose of medications). All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.|1 month clinic visit||||percentage of patient-clinician visits|||Number
2698276|NCT01257347|Primary|Percentage of Visits With Appropriate Hypertension Management|This is assessed using an algorithm in which patients are categorized as adherent or non-adherent based on electronic monitoring. If patients are adherent (summary measure of adherence to blood pressure medications in the week prior to visit is ≥ 80%), then hypertension management is appropriate if clinicians intensify the hypertension regimen or order testing for secondary hypertension. If patients are non-adherent (summary measure of adherence < 80%), then hypertension management is appropriate if clinicians take action to increase adherence through counseling or regimen simplification.|1 month clinic visit||||percentage of patient-clinician visits|||Number
2698277|NCT01257230|Secondary|Time to First Asthma Exacerbation During the 48 Week Treatment Period|The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|Week 48|FAS|||Participants|||Number
2698278|NCT01257230|Secondary|Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period|The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days.|48 weeks|FAS|||Participants|||Number
2698279|NCT01257230|Secondary|ACQ6 Responders|"Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)~The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS|||percentage of participants|||Number
2698280|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ6|"Change from baseline in AQC6 score at week 24.~The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||units on a scale||Standard Error|Mean
2698281|NCT01257230|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS|||percentage of participants|||Number
2698282|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24.~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||Units on a scale||Standard Error|Mean
2698283|NCT01257230|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||Number of puffs of rescue medication||Standard Error|Mean
2698284|NCT01257230|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||Number of puffs of rescue medication||Standard Error|Mean
2698285|NCT01257230|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and Week 24|FAS|||Number of puffs of rescue medication||Standard Error|Mean
2698431|NCT01256281|Primary|Pain Score in Legs (0-10)|"Pain score in legs at 2-4 hours after intervention will be the primary outcome.~Data analysis not done."|2-4 hours after intervention|||||||
2698286|NCT01257230|Secondary|FEF25-75 Change From Baseline|"Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres per second||Standard Error|Mean
2698287|NCT01257230|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
2698288|NCT01257230|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
2698289|NCT01257230|Secondary|Trough FVC Change From Baseline|"Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment.~The measured values presented are actually adjusted means.."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
2698290|NCT01257230|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0-3h) after 24 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
2698291|NCT01257230|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24.~The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
2698292|NCT01257230|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24.~Note, the measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set (FAS) was the same as the treated set which included all randomised patients who were dispensed trial medication and received at least one documents dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
2698293|NCT01257217|Secondary|Patient Reported Outcomes at Month 3|The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||units on a scale||Standard Deviation|Mean
2698294|NCT01257217|Secondary|Mean Radner Reading Speed|Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||wpm||Standard Deviation|Mean
2698295|NCT01257217|Secondary|Mean Refractive Spherical Equivalent at Month 3|A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||diopter||Standard Deviation|Mean
2698296|NCT01257217|Secondary|Uncorrected Visual Acuity Across a Range of Distances at Month 3|VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||logMAR||Standard Deviation|Mean
2698297|NCT01257217|Secondary|Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3|Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||logMAR||Standard Deviation|Mean
2698432|NCT01256190|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes||||participants|||Number
2698298|NCT01257217|Primary|Mean Binocular Defocus VA at Month 3|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||logMAR||Standard Deviation|Mean
2698299|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From end of treatment period up to Week 48 (follow-up period)|All follow-up participants.|||participants|||Number
2698300|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.|Baseline (Day 1) up to 24 weeks (treatment period)|All treated participants.|||participants|||Number
2698301|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
2698302|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 3. Here, n signifies the number of participants evaluable for the respective category."|||participants|||Number
2698303|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 2. Here, n signifies the number of participants evaluable for the respective category."|||participants|||Number
2698304|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
2698305|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 2.|||percentage of participants||80% Confidence Interval|Number
2698306|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
2698433|NCT01256190|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes||||participants|||Number
2698434|NCT01256190|Secondary|Incidence of Hemostasis at 5 Minutes|Number of subjects in each group that achieved hemostasis at pre-specified times after treatment|5 minutes||||participants|||Number
2698307|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 2.|||percentage of participants||80% Confidence Interval|Number
2698308|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
2698309|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 2.|||percentage of participants||80% Confidence Interval|Number
2698310|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with hepatitis C virus genotype 2.|||percentage of participants||80% Confidence Interval|Number
2698311|NCT01256983|Primary|Bedtime|"The mean bedtime assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group.~Bedtime is expressed in time (hours and minutes)"|Mean Bedtimes over 21 days for each period||||Hours||Standard Deviation|Mean
2698312|NCT01256944|Primary|Impaired Glucose Tolerance|Impaired glucose tolerance was defined as two hour glucose levels of 7.8-11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be <7 mmol/L.|1 years||||percentage of participants|||Number
2698313|NCT01256944|Primary|LDL|"Lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG).~Abnormal LDL was ≧4.14mmol/L."|1 year||||mmol/L||Standard Deviation|Mean
2698314|NCT01256944|Primary|HDL|"Metabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria:~abdominal obesity (waist circumference >80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L."|1 year||||mmol/L||Standard Deviation|Mean
2698315|NCT01256944|Primary|Triglycerides|Abnormal serum triglycerides defined as ≥ 1.7 mmol/L|1 year||||mmol/L||Standard Deviation|Mean
2698316|NCT01256944|Primary|Cholesterol|Hypercholesterolemia was defined as >6 mmol / L.|1 year||||mmol/L||Standard Deviation|Mean
2698317|NCT01256944|Primary|Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)|HOMA-IR = [fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)]/405.|1 year||||unitless||Standard Deviation|Mean
2698318|NCT01256944|Primary|Two Hour Glucose|"2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes.~World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year||||mmol/L||Standard Deviation|Mean
2698319|NCT01256944|Primary|Fasting Glucose|"Fasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes.~World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year||||mmol/L||Standard Deviation|Mean
2698320|NCT01256944|Primary|Fasting Insulin|A fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.|1 year||||μIU/ml||Standard Deviation|Mean
2698321|NCT01256944|Primary|BMI|BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).|1 year||||kg/m2||Standard Deviation|Mean
2698322|NCT01256944|Primary|Total Testosterone|Using serum total testosterone to represent the severity of hyperandrogenism.|1 year||||nmol/L||Standard Deviation|Mean
2698323|NCT01256918|Primary|Correlation Between Lens Thickness and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between~length thickness measurement using A scan biometer for each cataract and~penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery||||units on a scale||Standard Deviation|Mean
2698324|NCT01256918|Primary|Correlation Between Nuclear Opalescence and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between~nuclear opalescence as per LOCS III grading system for each cataract and~penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery||||units on a scale||Standard Deviation|Mean
2698325|NCT01256918|Primary|Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification|the nuclear colour grading as per LOCS III criteria for each case and the depth of penetration of phacotip required during a vertical chop was analysed to look for any correlation between the two.|day 0 of surgery||||units on a scale||Standard Deviation|Mean
2698435|NCT01256190|Secondary|Safety|Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)|28 days|All subjects treated were analyzed for safety. There were 39 subjects treated with Fibrocaps and 16 treated with gelatin sponge only, since 1 gel sponge subject was randomized but not treated.|||participants|||Number
2698326|NCT01256918|Secondary|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .|day 0 of surgery.|". In this observational study sample size was achieved by consecutive sampling of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria from Nov.2010 till March 2011 ,after a written informed consent.~Occurence of any posterior capsular rupture during vertical chop was noted as per protocol."|||participants|||Number
2698327|NCT01256918|Primary|Phacodepth Required to Achieve Full Thickness Nuclear Crack|phacodepth is the term used to describe the depth penetrated by the phacotip into the substance of lens.A note of depth penetrated by the tip to achieve full thickness nuclear crack shall be made.|day 0 of surgery|A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till Jan 2011 ,after a written informed consent.|||mm||Standard Deviation|Mean
2698328|NCT01256879|Primary|AUC|pharmacokinetic exposure (ng*hr/ml)|0-10 hours||||ng*hr/ml||Standard Error|Mean
2698329|NCT01256840|Primary|Telomere Length|This study is not a clinical trial, but the UCSF Committee on Human Research requires registration with clinicaltrials.gov. It is a ONE TIME POINT study, where we get a simple blood draw from people from three groups - calorie restricting, normal eating, and obese. Therefore, there IS NO FOLLOW UP/time frame. The outcome measure is assessed on the day of the study. Telomere length is a marker of cellular aging and is used to understand how the cells are aging. We will investigate whether long-term caloric restriction is associated cross-sectionally with longer telomere length (less aging).|One day||||ratio||Standard Deviation|Mean
2698330|NCT01256788|Primary|Tegner Activity Level Scale Score|The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function.|1 yr postop|Study ended earlier due to problematic recruitment issues related to a change in insurance payments. Each treatment groups experienced lost to follow up, therefore the number of participants analyzed is smaller than the number of participants enrolled for each group.|||score on a scale||Full Range|Mean
2698331|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2698332|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2698333|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2698334|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2698335|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who have self-identified moderate to severe vaginal dryness at Baseline.|||units on a scale||Standard Error|Mean
2698336|NCT01256684|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2698337|NCT01256684|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2698338|NCT01256684|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent-to-Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of superficial cells||Standard Error|Mean
2698339|NCT01256684|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of parabasal cells||Standard Error|Mean
2698340|NCT01256671|Primary|Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels|The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52.|||pg/mL||Standard Error|Mean
2698341|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching|The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS irritation/itching (being or not most bothersome (MBS)) (n=86); the analysis MBS/MS only includes subjects with MS irritation/itching being MBS (n=23)."|||units on a scale||Standard Error|Mean
2698342|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS dryness (being or not most bothersome (MBS)) (n=251); the analysis MBS/MS only includes subjects with MS dryness being MBS (n=81)."|||units on a scale||Standard Error|Mean
2698343|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS dyspareunia only includes subjects having MS dyspareunia (being or not most bothersome (MBS)) (n=240); the analysis MBS/MS only includes subjects with MS dyspareunia being MBS (n=183)."|||units on a scale||Standard Error|Mean
2698344|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal pH.|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."|||pH||Standard Error|Mean
2698345|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."|||percentage of superficial cells||Standard Error|Mean
2698436|NCT01256190|Primary|Time to Hemostasis|Time from application of treatment to cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis|||minutes||Standard Deviation|Mean
2698346|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."|||percentage of parabasal cells||Standard Error|Mean
2698347|NCT01256671|Primary|Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium|The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.|Baseline and Week 52 (or discontinuation)|Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis.|||Participants|||Count of Participants
2698348|NCT01256658|Secondary|Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50|"Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density > or = 5000/uL by microscopy.~Week (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1."|Week 1 to Week 50|Individual subject data from eligible randomized participants from Community Screening Campaign 1 (CSC1) for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and available form analysis and census data was obtained as per protocol.|||participants|||Number
2698349|NCT01256658|Secondary|Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined|Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and >3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.|12 months - period 1|Individual subject data from eligible clusters set defined as all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and census data was obtained as per protocol.|||participants|||Number
2698350|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy."|12 months - period 1|The number of units represents the number of clusters that include all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) were collected and census data were obtained as per protocol.|||percentage of participants|Participants|Standard Deviation|Mean
2698351|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data|"Data is presented per cluster. Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (>6 months and <5 years) was measured by Hemoglobin levels based on microscopy reading.~Mean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category."|Day 1 to day 28 - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Deviation|Mean
2698352|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data|Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (>6 months and <5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28.|Day 1 to Day 28- period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data was obtained as per protocol.|||participants|||Number
2698353|NCT01256658|Secondary|Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers|Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3).|Day 1, day 7 and day 28 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.|||percentage of participants|||Number
2698437|NCT01256177|Secondary|Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)|The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.|After 8 weeks of start of treatment|Full Analysis Set|||Participants|||Number
2698354|NCT01256658|Secondary|Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7|Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only.|Day 7 of CSC1, CSC2 and CSC3 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.|||percentage of participants|||Number
2698355|NCT01256658|Secondary|Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)|"Data is presented per cluster. Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all randomized participants (ages 5-9 years, 10-14 years, and ≥15 years) clusters for which CSC1 and CSC4 was conducted, data was available, and census data were obtained as per protocol.|||g/dL|Participants|Standard Deviation|Mean
2698356|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC4 was conducted, data was available, and census data was obtained as per protocol.|||participants|||Number
2698357|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 (CSC1/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.|||participants|||Number
2698358|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1|Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (>6 Months and <5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 and day 28 - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.|||g/dL||Standard Deviation|Mean
2698359|NCT01256658|Secondary|Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)|Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4.|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.|||participants|||Number
2698360|NCT01256658|Secondary|Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.~Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|Eligible clusters set consisted of all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Deviation|Mean
2698361|NCT01256658|Secondary|Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.~Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC 1, 2 3 and 4 was conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Deviation|Mean
2698362|NCT01256658|Secondary|Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (infants and children (> 6 months and < 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable carriers set consisted of all infants and children (> 6 months and < 5 years)) from intervention clusters confirmed positive for P. falciparum asexual forms at any CSC or when migrating into the cluster, who in the absence of clinical signs and symptoms received at least one dose of COA566 for the diagnosed asymptomatic infection.|||participants|||Number
2698363|NCT01256658|Secondary|Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable asymptomatic carriers set consisted of all consenting inhabitants from intervention clusters confirmed positive by RDT for P. falciparum asexual forms at any CSC or when migrating into the cluster, in the absence of clinical signs and symptoms who received at least one dose of COA566 to treat the diagnosed asymptomatic infection.|||participants|||Number
2698364|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)|"Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|12 months - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.|||SMRC5000 per person-year|||Number
2698365|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)|"Data is presented per cluster. Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (>6 months and <5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized participants for which CSCs 1 and 4 were conducted, data was available, and census data were obtained as per protocol.|||g/dL|Participants|Standard Deviation|Mean
2698366|NCT01256658|Secondary|Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.|||participants|Participants|Standard Error|Mean
2698367|NCT01256658|Secondary|Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Error|Mean
2698368|NCT01256658|Primary|Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)|"Data is presented per cluster. Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), > 6 months of age, at day 1 and at day 28."|Day 1 and day 28 of period 1|The number of units represents the number of clusters that include all randomized, > 6 months of age participants for which CSC1 was conducted, data was available and census data were obtained as per protocol.|||g/dL|Participants|Standard Deviation|Mean
2698369|NCT01256658|Primary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC.~Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|Month 12 of period 1|The number of units represents the number of clusters that include all randomized infants and children (<5 years) for which CSCs 1, 2, and 3 were conducted, data was available, and census data were obtained as per protocol.|||SMRC5000 per person-year|Participants|Standard Deviation|Mean
2698370|NCT01256593|Secondary|Physician's Impression (CGIC) at Week 13|The physician's impression (clinical global impression of change [CGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.|At Week 13|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available and who satisfied the inclusion criteria among the baseline analysis population.|||Participants|||Number
2698371|NCT01256593|Secondary|Patient's Impression (PGIC) at Week 13|The patient's impression (patient global impression of change [PGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.|At Week 13|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available and who satisfied the inclusion criteria among the baseline analysis population.|||Participants|||Number
2699470|NCT01249625|Secondary|Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Influenza-like Illnesses|Number of influenza-like illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.|60 weeks||||number of influenza-like illnesses|||Number
2698372|NCT01256593|Secondary|Change From Baseline in Participant-rated Sleep Interference Score at Week 13|The sleep interference (inability to sleep because of pain) experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.|Baseline and at Week 13|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated sleep interference score was available and who satisfied the inclusion criteria among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2698373|NCT01256593|Secondary|Change From Baseline in Participant-rated Pain Score at Week 13|The pain experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.|Baseline and at Week 13|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of participant-rated pain score was available and who satisfied the inclusion criteria among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2698374|NCT01256593|Secondary|Clinical Effectiveness Rate|Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 13 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis.|At Week 13|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of clinical effectiveness was available and who satisfied the inclusion criteria among the baseline analysis population. Of these, participants evaluated as “impossible to judge” were excluded from the analysis population.|||Percentage of Participants||95% Confidence Interval|Number
2698375|NCT01256593|Secondary|Number of Participants With Adverse Drug Reactions Related to Vision-related Events|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.|13 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2698376|NCT01256593|Secondary|Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.|13 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2698377|NCT01256593|Secondary|Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.|13 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2698378|NCT01256593|Secondary|The Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.|13 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2698379|NCT01256593|Secondary|Percentage of Participants With Serious Adverse Drug Reaction|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.|13 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2698380|NCT01256593|Primary|Percentage of Participants With Adverse Drug Reaction|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.|13 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2698381|NCT01256567|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab||Day 1 of Cycle 1 and 4 (cycle=21 days)|All participants with evaluable Vss data at the specified time points.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2698387|NCT01256567|Primary|Number of Participants With Adverse Events|Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.|Baseline up to data cut off (approximately 48.3 weeks)|All participants who received at least 1 dose of study drug.|||participants|||Number
2698388|NCT01256502|Secondary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points|Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|Stage 2 Surgery, Months 12, 18 and 24|Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.|||units on a scale||Standard Deviation|Mean
2698389|NCT01256502|Secondary|Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery|Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.|Immediately following Stage I surgery|Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.|||participants|||Number
2698390|NCT01256502|Primary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months|The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|6 months|Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.|||units on a scale||Standard Deviation|Mean
2698391|NCT01256476|Primary|Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12||Baseline and 12 weeks|All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.|||percent||Standard Error|Mean
2698392|NCT01256450|Secondary|Use of Rescue Medication|Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.|Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication|||Tablets per day||Standard Deviation|Mean
2698393|NCT01256450|Secondary|Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug|Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
2698394|NCT01256450|Secondary|Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug|Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
2698395|NCT01256450|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication|||units on a scale||Standard Deviation|Mean
2698396|NCT01256450|Secondary|Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
2698397|NCT01256450|Secondary|Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale|Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
2698398|NCT01256450|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2698400|NCT01256450|Secondary|Change From Baseline in Pain Intensity Over Time Using NRS Scale|Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
2698401|NCT01256450|Primary|Change in Pain Intensity From Baseline to Week 12|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
2698402|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 9 Months After First Treatment|Response was defined as absence of HSIL, and absence of oncogenic HPF if LSIL|9 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.|||percentage of participants|||Number
2698403|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment.|Response was defined as absence of HSIL, and absence of oncogenic HPV if LSIL.|6 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.|||percentage of participants|||Number
2698404|NCT01256424|Secondary|Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|HPV response was defined as clearance of baseline HPV infection, asssessed by genotype|3 months after treatment|Patients with CIN2 at baseline, based on central histology read, and HPV positive at baseline|||percentage of patients|||Number
2698405|NCT01256424|Primary|Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.|3 months after last treatment|Patients with CIN2 at baseline, based on central histology review|||percentage of patients|||Number
2698406|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||Participants|||Number
2698407|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||Participants|||Number
2698408|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||mmHg||Standard Deviation|Mean
2698409|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||mmHg||Standard Deviation|Mean
2698410|NCT01256411|Primary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)|Participants were monitored throughout the study for adverse events, serious adverse events and deaths.|Baseline to 12 months|Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group.|||Participants|||Number
2698411|NCT01256398|Secondary|Response||Up to 10 years|||||||
2698412|NCT01256398|Secondary|DFS|Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.|From the date of first induction CR to relapse, or death due to any cause, with patients last known to be alive and disease-free censored at the date of last contact, assessed up to 10 years|||||||
2698413|NCT01256398|Secondary|OS|Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.|Up to 10 years|||||||
2698414|NCT01256398|Secondary|Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR)|Proportions will be estimated based on the combined and individual cohorts.|Up to 10 years|||||||
2698415|NCT01256398|Secondary|Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)|Proportions will be estimated based on the combined and individual cohorts.|Up to 10 years|||||||
2698416|NCT01256398|Primary|Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause|Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.|At 3 years after CR|All patients that reached CR and chose to continue with the study.|||percentage of patients||95% Confidence Interval|Number
2698417|NCT01256385|Secondary|Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.|Assessed according to RECIST. This is includes complete and partial responses as well as stable disease, and is different from Outcome Measure 6 above, which includes only complete and partial responses.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2698418|NCT01256385|Secondary|PFS of Myofibroblast (+) Cohort||From start of treatment to time of progression or death of any cause, assessed up to 5 years|Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore.||||||
2698419|NCT01256385|Secondary|Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST|Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2698420|NCT01256385|Secondary|Grade 3 or Higher Hematological Toxicity|Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2698421|NCT01256385|Secondary|PFS vs. Historical Control Cohort|PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.|From start of treatment to time of progression or death of any cause, assessed at 4 months|Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.|||percentage of participants||90% Confidence Interval|Number
2698422|NCT01256385|Secondary|Overall Response Rates (OR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2698423|NCT01256385|Secondary|Overall Survival (OS)|Time from randomization until death from any cause|Up to 5 years||||days||95% Confidence Interval|Median
2698424|NCT01256385|Primary|Progression-free Survival (PFS)|Progression determined using RECIST criteria: >=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.|From start of treatment to time of progression or death from any cause, assessed up to 5 years||||days||95% Confidence Interval|Median
2698425|NCT01256294|Primary|Dose-normalized Maximum Plasma Drug Concentration (Cmax) at Steady State|Maximum (peak) plasma drug concentration after drug administration at steady state (after 14 days of treatment with each study drug). Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor.|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2698426|NCT01256294|Secondary|Number of Participants With Reported Biopsy Proven Acute Rejection Episodes||28 Days|Full analysis set.|||participants|||Number
2698427|NCT01256294|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. An SAE was an event which: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; required or prolonged inpatient hospitalization; was medically significant, i.e., an event that jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|28 Days|Safety set|||participants|||Number
2698428|NCT01256294|Secondary|Trough Plasma Drug Concentration (C0) at Steady State|Trough plasma drug concentration measured prior to drug administration at steady state (after 14 days of treatment with each study drug).|Days 14 and 28: predose|PK analysis set, where data were available.|||ng/mL||Standard Deviation|Mean
2698429|NCT01256294|Secondary|Intra-patient Variability of Tacrolimus Pharmacokinetic Parameters|The intra-patient variability of tacrolimus pharmacokinetics of each formulation was evaluated by comparing AUC0-12h, maximum drug concentration (Cmax) and trough drug concentration (C0) at Days 7 and 14, and Days 21 and 28. Intra-patient variability was assessed by a calculation of the coefficient of variation, by patient, using the repeated measurements within each Period, where the coefficient of variation (%) = standard deviation/mean*100.|Days 7 and 14, and Days 21 and 28.|PK Analysis set.|||percent coefficient of variation||Standard Error|Mean
2698430|NCT01256294|Primary|Dose-Normalized Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) at Steady State|"Dose-normalized area under the concentration-time curve from time 0 to 12 hours (AUC0-12h) at steady state after 14 days of treatment with each study drug.~Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor."|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.|||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
2698438|NCT01256177|Secondary|Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation|MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114)|||Scores on a scale||Standard Error|Least Squares Mean
2698439|NCT01256177|Secondary|"The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved"|"Clinical Global Impression - Bipolar - Change (CGI-BP-C) of much or Very much improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved."|After 8 weeks of start of treatment|Full Analysis Set|||Participants|||Number
2698440|NCT01256177|Secondary|Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)|CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease|Baseline to Week 8|Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112)|||Scores on a scale||Standard Error|Least Squares Mean
2698441|NCT01256177|Secondary|Change From Baseline to Week 8 in HAM-D Total Scores|HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114).|||Scores on a scale||Standard Error|Least Squares Mean
2698442|NCT01256177|Secondary|Change From Baseline to Each Assessment in MADRS Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe.|Baseline to Week 8|Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)).|||Scores on a scale||Standard Error|Least Squares Mean
2698443|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12|After 8 week of start of treatment|Full Analysis Set|||Participants|||Number
2698444|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline|8 weeks from baseline|Full Analysis set|||Participants|||Number
2698445|NCT01256177|Primary|Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114)|||Scores on a scale||Standard Error|Least Squares Mean
2698446|NCT01256164|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes||||participants|||Number
2698447|NCT01256164|Secondary|Number of Participants Achieving Hemostasis at 5 Minutes||5 minutes||||participants|||Number
2698448|NCT01256164|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes||||participants|||Number
2698449|NCT01256164|Secondary|Safety|Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS|28 Days|All subjects treated were analyzed for safety.|||participants|||Number
2698450|NCT01256164|Primary|Mean Time to Hemostasis (TTH)|Time to hemostasis recorded from the first application of study treatment until cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis|||minutes||Standard Deviation|Mean
2698451|NCT01256086|Primary|PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)|The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.|60 min after application of study medication|Per Protocol Population|||mg/ml||Geometric Coefficient of Variation|Geometric Mean
2698452|NCT01256060|Other Pre-specified|Measures of Social Function - The Clinical Global Impressions - Social Scale (Baseline to Week 12)|"Social Function~a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale)."|12 Weeks||||participants|||Number
2698453|NCT01256060|Other Pre-specified|Changes in Measures of Social Cognition, Social Function, Repetitive Behaviors, and Anxiety (Baseline to Week 12)|"Social Cognition (higher score=positive response)~Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100)~Eyes Test (0-28)~Strange Stories (0-16)~Irony and Empathy (0-24)~Social Function~Aberrant Behavior Checklist (0-48) (lower score=positive response)~Behavioral Assessment System for Children (higher score=positive response); i. Social: age 8 to 11 & 15 to 18 (18-69); age 12 to 14 (21-70); ii. Functional: age 8 to 14 (10-66); age 15 to 18 (10-64)~Social Responsiveness Scale (higher score=positive response); male (34-127); female (35-142)~Anxiety (lower score=positive response)~a. Child Symptom Inventory; i. Separation: male (44-106); female (44-101); ii. Generalized: male (40-101); female (41-96)~Repetitive Behaviors (lower score=positive response)~Child Yale-Brown Obsessive-Compulsive Scale (0-20)~Repetitive Behavior Scale (0-129)~Measures insensitive to change will be omitted from results."|12 Weeks||||units on a scale||95% Confidence Interval|Mean
2698454|NCT01256060|Secondary|Blood Levels of Oxytocin During the Trial in Relation to Safety or Treatment Response|Children and adolescents with minimal changes in plasma level of oxytocin after treatment will be less responsive to treatment. Children and adolescents with atypical patterns of increase in oxytocin may be more sensitive to dose-related tolerability.|12 Weeks||2016-12-31|12/2016||||
2701462|NCT01234649|Secondary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR, a measure of insulin resistance derived from fasting values, in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||index||Standard Deviation|Mean
2698455|NCT01256060|Secondary|Baseline Levels of Oxytocin in Relation to Either Safety or Treatment Response|Children and adolescents with lower plasma oxytocin levels at baseline will show treatment related changes in social cognition. Children and adolescents with higher oxytocin plasma levels will show diminished or less dramatic treatment responses and may have more difficulty tolerating the treatment.|12 Weeks||2016-12-31|12/2016||||
2698456|NCT01256060|Primary|Number of Participants With Serious Adverse Events|This will be reported as the number of participants who experienced a serious advert event throughout the study.|24 Weeks||||participants|||Number
2698457|NCT01256060|Primary|Maximum Tolerated Dose (MTD)|The hypothesis is that the maximum tolerated dose in a range of 0.2-0.4 IU/kg / dose will be 0.4 IU/kg / dose, as was the case in the adult study, given that oxytocin is not stored in body fat and does not depend on liver or renal clearance.|12 Weeks||||IU / kg|||Number
2698458|NCT01256034|Secondary|Plasma IL-6, CRP, Th1/Th2 Balance||14 days|||||||
2698459|NCT01256034|Primary|Postoperative Infectious Complication||30 days||||participants|||Number
2698460|NCT01256008|Secondary|Functional Assessment of Cancer Treatment (FACT-B)|"The scale is used to assess the life quality of patients.~The scale includes 5 subscales. The scores of each scale are summed to compute a total score.~The scale range is 0-144. Higher score indicates better life quality.~The scale was assessed at baseline,4 week,12 week,24 week."|baseline, 4w,12w,24w||||units on a scale||Standard Deviation|Mean
2698461|NCT01256008|Secondary|Athens Insomnia Scale(AIS)|"The scale is used to assess the sleep quality of patients.~The scale range of AIS is 0-21. Higher score indicates worse sleep quality.~The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline, 4w,8w,12w,24w||||units on a scale||Standard Deviation|Mean
2698462|NCT01256008|Primary|Hamilton Anxiety Scale (HAMA-14)|"The scale(HAMA-14) is used to assessed the anxiety symptoms of patients.~The scale range is 0-56.Higher value represents a worse outcome.~The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week."|baseline,2 w,4 w,8 w,12 w,16 w,24 w||||units on a scale||Standard Deviation|Mean
2698463|NCT01256008|Secondary|Visual Analogue Scale (VAS)|"The scale is used to assess the pain intensity of patients.~The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.~The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline,4 w,8 w,12 w,24 w||||units on a scale||Standard Deviation|Mean
2698464|NCT01256008|Primary|Hamilton Depression Rating Scale (HAMD-17)|"The scale(HAMD-17) is used to assessed the depression symptoms of patients.~The scale range is 0-53.Higher value represents a worse outcome.~The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week"|baseline,2 w,4 w,8 w,12 w,16 w,24 w||||units on a scale||Standard Deviation|Mean
2698465|NCT01255904|Primary|Time to Complete Study|Time from medication administration to study completion.|60-180 minutes||||Minutes||95% Confidence Interval|Median
2698466|NCT01255787|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2698467|NCT01255787|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2698468|NCT01255787|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||percentage of participants|||Number
2698469|NCT01255787|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||percentage of participants|||Number
2698470|NCT01255787|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
2699471|NCT01249625|Primary|Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events|Number of influenza A and B events in healthcare practitioners wearing N95 respirators compared to medical masks.|60 weeks||||number of influenza A and B events|||Number
2698471|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2698472|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with hired outside help||Standard Deviation|Mean
2698473|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Activity days missed||Standard Deviation|Mean
2698474|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with reduced household work||Standard Deviation|Mean
2698475|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with no household work||Standard Deviation|Mean
2698476|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2698477|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Work days with reduced work productivity||Standard Deviation|Mean
2698478|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Number of work days missed in last month||Standard Deviation|Mean
2698479|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity."|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2698480|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with hired outside help||Standard Deviation|Mean
2698481|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Activity days missed||Standard Deviation|Mean
2698482|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with reduced household work||Standard Deviation|Mean
2698483|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with no household work||Standard Deviation|Mean
2698484|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2698485|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Work days with reduced work productivity||Standard Deviation|Mean
2698486|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Number of work days missed in last month||Standard Deviation|Mean
2698487|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698488|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698489|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698490|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698491|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698492|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2699358|NCT01250730|Primary|Terminal Elimination Half-life (t1/2) of Crizotinib|"t1/2 of crizotinib is the time measured for the plasma concentration to decrease by one half. It is obtained from a Loge(2)/kel.~Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||hours||Standard Deviation|Mean
2698493|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698494|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698495|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698496|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698497|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698498|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
2698499|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
2698500|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
2698501|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
2698502|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
2698503|NCT01255761|Secondary|Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52|"The DAS28(ESR) score is a measure of the subject's disease activity.~DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
2698504|NCT01255761|Secondary|Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12|"The DAS28(ESR) score is a measure of the subject's disease activity.~DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
2698505|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
2698506|NCT01255761|Secondary|Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|"The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages.~The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis."|||percentage of participants|||Number
2698507|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
2698616|NCT01254604|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.|Up to Week 4|APaT population|||participants|||Number
2698508|NCT01255761|Primary|Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
2698509|NCT01255761|Primary|Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined.~RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status."|Baseline (Week 0) to Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
2698510|NCT01255722|Secondary|Average Contrast-to-noise Ratio (Average CNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU).~A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.~In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att - Baseline Att) / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.|||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
2698511|NCT01255722|Secondary|Average Signal-to-Noise Ratio (Average SNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories.~A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.~Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula:~SNR Territory = Post Attenuation / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.|||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
2698512|NCT01255722|Secondary|Average Signal Attenuation After IV Injection of Contrast|Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.|<1h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Hounsfield Units||Standard Deviation|Geometric Mean
2698513|NCT01255722|Secondary|Coronary Track Rate|A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.|<24h|Full Analysis Set population: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Number of tracked segments per patient||Standard Deviation|Mean
2698514|NCT01255722|Secondary|Average Image Quality According to Off-site Reading|For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).|<24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Image quality Score on a scale||Standard Deviation|Mean
2698515|NCT01255722|Primary|Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment|"Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic.~A patient's CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0."|< 24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Percentage of patients||Standard Error|Geometric Mean
2698516|NCT01255631|Secondary|Narcotic Pain Medications|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.|Post-Operative Period|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs.||||||
2698517|NCT01255631|Secondary|Lymphedema|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.||||||
2698518|NCT01255631|Secondary|Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables due to lack of post-clinical assessment data and poor patient compliance with the 14 day mark follow up.||||||
2698519|NCT01255631|Secondary|Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms.||||||
2698520|NCT01255631|Secondary|Jackson Pratt (JP) Drain Output|Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.|Post-Operative Day 1 & 2 (2 Days)|For the 7 patients who completed the study, the mean and standard deviations for the total JP drain output (in milliliters - mL) from post-operative days 1 & 2 (2 days total) were analyzed as a secondary outcome.|||milliliters (mL)||Standard Deviation|Mean
2698521|NCT01255631|Primary|Pain Level on Visual Analog Scale|Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).|2 weeks|Only 7 patients completed the study by quantifying the level of their pain post-operatively on a visual analog scale from 0-10. The medication logs and two week post-op analogs could not be utilized for the analysis since all 7 patients did not complete these logs.|||units on a scale||Standard Deviation|Mean
2698522|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698523|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698524|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698525|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698526|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2699359|NCT01250730|Primary|Time to Cmax (Tmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Full Range|Median
2699360|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Standard Deviation|Geometric Mean
2698527|NCT01255592|Secondary|Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698528|NCT01255592|Secondary|Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698529|NCT01255592|Secondary|Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698530|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698531|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698532|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698533|NCT01255592|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698534|NCT01255592|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698535|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698536|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698546|NCT01255592|Secondary|Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698537|NCT01255592|Secondary|Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)|"SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:~Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status)."|Baseline and end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
2698538|NCT01255592|Secondary|Change From Baseline for the Symptom Scores of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
2698539|NCT01255592|Secondary|Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||L/min||Standard Error|Least Squares Mean
2698540|NCT01255592|Secondary|Transition Dyspnea Index (TDI) at End of Treatment (Day 28)|TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
2698541|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters/second||Standard Error|Least Squares Mean
2698542|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2698543|NCT01255592|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2698544|NCT01255592|Secondary|Change From Baseline in Slow Vital Capacity (SVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2698545|NCT01255592|Secondary|Change From Baseline in Weight of 24-hour Sputum Collection|Patients collected all sputum produced during a 24-hour period at baseline and Day 28.|Baseline and end of treatment (Day 28)|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||grams||Standard Error|Least Squares Mean
2698547|NCT01255592|Primary|Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
2698548|NCT01255449|Secondary|Post-HSCT Changes in Lung Tissue Density|Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT|Before and 2 months after HSCT|CT scans, in a format suitable for software analysis, were available in 8 patients only|||g/mL||Standard Deviation|Mean
2698549|NCT01255449|Primary|Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)|2 weeks before and 2 months after HSCT||||1/cmH2O*s||Standard Deviation|Mean
2698550|NCT01255436|Secondary|Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks|The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.|||percentage of participants|||Number
2698551|NCT01255436|Secondary|Medication Adherence Rate|The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.|||percentage of participants|||Number
2698552|NCT01255436|Primary|Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks|Absolute change in diastolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only patients who completed follow up and had evaluable data were analyzed.|||mmHg||Standard Deviation|Mean
2698553|NCT01255436|Primary|Mean Absolute Change in Systolic Blood Pressure After 12 Weeks|Absolute change in systolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only participants who completed follow up and had evaluable data were analyzed.|||mmHg||Standard Deviation|Mean
2698554|NCT01255423|Secondary|Ankle Joint Function|"Ankle joint function score (Karlsson Scoring scale which ranges from 0 worst possible score to 90 best possible score)at 24 and 72 hours and 7 days."|24 and 72 hours, 7 days||||Total score||Standard Deviation|Mean
2698555|NCT01255423|Secondary|Tenderness|Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.|Change from baseline at 24 and 72 hours, 7 days||||N/cm^2||Standard Deviation|Mean
2698556|NCT01255423|Secondary|Onset of Pain Relief|Onset of perceptible pain relief|Day 1||||Hour||Inter-Quartile Range|Median
2698557|NCT01255423|Secondary|Pain on Movement|"Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|24 hours and 7 days||||mm||Standard Deviation|Mean
2698558|NCT01255423|Primary|Pain on Movement|"Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|72 hours||||mm||Standard Deviation|Mean
2698559|NCT01255306|Secondary|Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade|To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.|6 months|We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol.|||micrometer|Participants|Standard Deviation|Mean
2698560|NCT01255306|Primary|Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography|Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.|6 months|We included all patients that have completed necessary follow up visits and have had optical coherence tomography measurements at all visits in the final analysis.|||micrometer|Participants|Standard Deviation|Mean
2698561|NCT01255163|Secondary|Body Mass Index (BMI)|Body Mass Index defined as a person's weight in kilograms (kg) divided by his or her height in meters squared.|18 months||||kg/m^2||Standard Deviation|Mean
2698562|NCT01255163|Secondary|Cerebrospinal Fluid Amyloid-beta 42 (CSF Abeta42)|Abeta42 peptide measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio|18 months||||pg/dl||Standard Deviation|Mean
2698563|NCT01255163|Secondary|Cerebrospinal Fluid phospho181-tau (CSF p181-tau)|p-181-Tau measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio|18 months||||pg/dl||Standard Deviation|Mean
2698564|NCT01255163|Secondary|Cerebrospinal Fluid (CSF) Total Tau|Total Tau measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio|18 months||||pg/dl||Standard Deviation|Mean
2698565|NCT01255163|Secondary|Clinical Dementia Rating (CDR) Sum of Boxes|"Sum of the Clinical Dementia Rating boxes (memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care). Each box is rated as 0, 0.5, 1, 2 or 3. Range for the sum of boxes is 0 - 18. Higher scores reflect a greater severity of dementia."|18 months||||units on a scale||Standard Deviation|Mean
2698566|NCT01255163|Secondary|Clinical Dementia Rating (CDR) Global Score|Clinical Dementia Rating global score range: 0 (no dementia); 0.5 (Mild Cognitive Impairment); 1 (mild dementia); 2 (moderate dementia); 3 (severe dementia). Higher is worse.|18 months||||units on a scale||Standard Deviation|Mean
2698567|NCT01255163|Secondary|Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog70)|Alzheimer's dementia scale cognitive sub-scale range: 0 - 70 points (higher is worse)|18 months||||units on a scale||Standard Deviation|Mean
2698568|NCT01255163|Secondary|Mini Mental State Examination (MMSE)|Scale range: 0 - 30 points (higher is better)|18 months||||units on a scale||Standard Deviation|Mean
2698571|NCT01255137|Primary|Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameter. Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: the appearance of one or more new lesions is also considered progression). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum diameters while on study.|2 years||||Participants|||Number
2698572|NCT01254890|Secondary|Phase II: Number of Participants With Response|Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of <5% blasts in the bone marrow (BM), with >1 X 10^9/L neutrophils and >100 x 10^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of >/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.|90 days|Nine participants were not evaluable for response.|||participants|||Number
2698573|NCT01254890|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine|MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine|28 day cycle||||mg/twice daily|||Number
2698574|NCT01254877|Secondary|HIV Medication Adherence|The investigators will obtain patient self reports of the number of HIV medication doses taken as a function of the total number of doses prescribed. The adherence measure is expressed as the % of prescribed doses.|16 weeks||||percentage of prescribed doses||Standard Deviation|Mean
2698575|NCT01254877|Secondary|Alcohol-related Problems|"Alcohol-related problems were measured using the Short Inventory of Problems - revised (SIP-R), a self-report inventory of adverse consequences associated with alcohol and drug use. The SIP instructs participants to indicate how often each of 15 consequences has occurred during the past three months (never, once or a few times, once or twice a week, daily or almost daily; scored 0-3). Item responses are summed to produce a total score and five subscale scores. Total scores range from 0 - 45."|16 weeks||||units on a scale||Standard Deviation|Mean
2698576|NCT01254877|Secondary|Number of Subjects Who Discontinue Due to Side Effects|The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.|16 weeks||||Participants|||Count of Participants
2698577|NCT01254877|Secondary|Medication Safety|Medication side-effects and adverse events were measured using the Systematic Assessment for Treatment of Emergent Events (SAFTEE). The SAFTEE contains 25 detailed questions that systematically address 29 body systems. A trained interviewer elicits information about onset, duration, pattern, and judgment of attribution. For the present trial outcome, we report number of events.|16 weeks||||number of events||Standard Deviation|Mean
2698578|NCT01254877|Primary|Number of Days/Week Abstinent From Alcohol|The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7.|16 weeks||||days/week abstinent from alcohol||Standard Deviation|Mean
2698579|NCT01254877|Primary|Number of Alcoholic Containing Drinks Per Drinking Day|The Time-line Follow-back (TLFB; Sobell, Sobell, Leo & Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period|16 weeks||||Standard alcohol drinks per drinking day||Standard Deviation|Mean
2698580|NCT01254851|Primary|Number of Steps Taken in 24 Hours.|The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.|1 day|The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.|||Steps||Full Range|Median
2698581|NCT01254760|Secondary|Overall Fit|Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|Day 5, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale|Participants|Standard Deviation|Mean
2698582|NCT01254760|Primary|Overall Vision|Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2698583|NCT01254760|Primary|Handling at Removal|Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2698584|NCT01254760|Primary|End of Day Dryness|End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2698585|NCT01254760|Primary|End of Day Comfort|End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2698586|NCT01254747|Secondary|Overall Satisfaction|Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2698587|NCT01254747|Secondary|Corrected Visual Acuity|Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||logMAR|Participants|Standard Deviation|Mean
2698588|NCT01254747|Secondary|Lens Fit|Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale|Participants|Standard Deviation|Mean
2698589|NCT01254747|Primary|Average Daily Wear Time|Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Hours||Standard Deviation|Mean
2698590|NCT01254747|Primary|Dryness Throughout the Day|Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2698591|NCT01254747|Primary|Overall Handling|Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2698592|NCT01254747|Primary|Vision Quality During the Day|Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2698593|NCT01254747|Primary|Overall Comfort|Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2698594|NCT01254721|Primary|The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29|The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.|From Baseline to Day 29||||scores on the scale||Standard Deviation|Mean
2698595|NCT01254721|Secondary|The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)|"The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is Normal, not at all ill and a score of 7 indicates that a patient is Among the most extremely ill patients."|From Baseline to Day 29||||scores on the scale||Standard Deviation|Mean
2698596|NCT01254669|Secondary|The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.|post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)|1 hour after intervention|The number of participants for analysis was determined based on the total enrolled and who responded to knowledge questions|||units on a scale||Standard Deviation|Mean
2698597|NCT01254669|Primary|The Receipt of the First HPV Vaccination|Receipt of the first HPV vaccination among adolescent daughters of the participants|within 1 month of randomization|The number of participants for analysis was determined based on number of participants enrolled and who answered questions of interest.|||percentage of participants|||Number
2698598|NCT01254656|Secondary|Virology Analysis Participant Accountability From Week 96 Through Study Termination|"Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. protocol-defined treatment failure was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. Treatment failure: treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. NRTI or NNRTI resistance mutations: nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both."|Week 96 through study termination|The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA >500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.|||Participants|||Number
2698599|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.|||Percentage||Standard Deviation|Mean
2698600|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.|||cells/uL||Standard Deviation|Mean
2698601|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. LOCF was used to impute missing values.|||Percentage||Standard Deviation|Mean
2698602|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.|||cells/uL||Standard Deviation|Mean
2698603|NCT01254656|Secondary|Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.|Up to Week 208|Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels >=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.|||Participants|||Number
2698604|NCT01254656|Primary|Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV‑1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.|||Participants|||Number
2698605|NCT01254643|Secondary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.|||milli Merck units/mL||95% Confidence Interval|Geometric Mean
2698606|NCT01254643|Primary|Percentage of Participants With a Vaccine-related AE|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be definitely related, probably related, or possibly related to the study drug is defined as a vaccine-related AE."|up to 15 days after any vaccination|Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data.|||Percentage of Participants|||Number
2698607|NCT01254643|Primary|Percentage of Participants With a Non-Injection Site (Systemic) AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.|||Percentage of Participants|||Number
2698608|NCT01254643|Primary|Percentage of Participants With an Injection-site Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.|||Percentage of Participants|||Number
2698609|NCT01254643|Primary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.|||Percentage of Participants||95% Confidence Interval|Number
2698610|NCT01254630|Other Pre-specified|Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to approximately 118 days)|The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis|||percentage of participants|||Number
2698611|NCT01254630|Secondary|Incidence of Postherpetic Neuralgia|Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.|Up to 6 months after onset of HZ (up to approximately 5 years)|This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2698612|NCT01254630|Secondary|Incidence of Herpes-Zoster Complications|The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.|Up to 6 months after onset of HZ (up to approximately 5 years)|This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2698613|NCT01254630|Secondary|Incidence of Moderate to Severe Herpes-Zoster-Associated Pain|Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score of 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.|Up to 6 months after onset of HZ (up to approximately 5 years)|This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2698614|NCT01254630|Primary|Percentage of Participants With One or More Serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to approximately 118 days)|The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis|||percentage of participants||95% Confidence Interval|Number
2698615|NCT01254630|Primary|Incidence of Confirmed Herpes-Zoster|Clinical criteria for suspected HZ cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.|Up to approximately 5 years|This analysis was based on the Modified Intent-to-Treat (MITT) population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2698617|NCT01254604|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.|Up to 14 days after Week 4 visit|APaT population|||participants|||Number
2698618|NCT01254604|Secondary|Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye|"IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one study eye was identified for data summarization and analysis. The study eye was the eye with the higher (i.e., worse) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the study eye. Percent reduction in IOP at Week 4 = ([baseline IOP value − Week 4 IOP value]/Baseline IOP value)*100."|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint|||participants|||Number
2698619|NCT01254604|Primary|Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye|"IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one study eye was identified for data summarization and analysis for this primary efficacy outcome measure. The study eye was the eye with the higher (i.e., worse) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the study eye. Change from baseline in IOP at Week 4 = Week 4 IOP value − baseline IOP value."|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint|||mmHg||95% Confidence Interval|Least Squares Mean
2698620|NCT01254565|Secondary|Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase||Efficacy assessment phase|Modified intent to treat population|||percentage of participants|||Number
2698621|NCT01254565|Secondary|Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.|||percent change||Standard Deviation|Mean
2698622|NCT01254565|Secondary|Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.|||percent change||Standard Deviation|Mean
2698623|NCT01254565|Secondary|Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data|||percent change||Standard Deviation|Mean
2698624|NCT01254565|Secondary|Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population|||percentage of participants|||Number
2698625|NCT01254565|Secondary|Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population|||percentage of participants|||Number
2698626|NCT01254565|Primary|Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
2698627|NCT01254552|Secondary|Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis|"The degree of coronary artery stenosis on CCTA was assessed according to the following scale:~No stenosis: 0%~Non significant stenosis: 1-50%~Significant stenosis >50% and ≤99%~Occlusion: 100%"|From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)||||Participants|||Count of Participants
2698628|NCT01254552|Primary|Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus||From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)||||Participants|||Count of Participants
2698629|NCT01254422|Primary|GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.|Pre-Injection 1 and Post- Injections 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2698630|NCT01254422|Primary|GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.|Pre-Injection 1 and Post-Injections 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2698631|NCT01254422|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants|Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.|Pre-Injection 1 and Post-Injections 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2698632|NCT01254422|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants|Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.|Pre-Injection 1 and Post-Injections 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2698633|NCT01254422|Primary|Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT.|Pre-Injection 1 and Post-Injections 2 and 3|Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2698634|NCT01254422|Primary|Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT.|Pre-Injection 1 and Post-Injections 2 and 3|Analysis was performed on Full analysis set.|||Percentage of participants|||Number
2698635|NCT01254422|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Pre-Injection 1 and Post-Injections 2 and 3|Analysis was performed on Full analysis set which included participants who received at least one injection of CYD dengue vaccine or placebo and had at least one valid post-injection serology result. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2698636|NCT01254422|Primary|Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.|Day 0 up to Day 14 post-each vaccination|Analysis was performed on safety analysis set. Here, ''overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2699546|NCT01249118|Primary|Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973|Cmax(dn) is Cmax divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2698637|NCT01254422|Primary|Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample.|Day 0 up to Day 14 post-each vaccination|Analysis was performed on safety analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2698638|NCT01254422|Primary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity.|Day 0 up to Day 14 post-any and each vaccination|Analysis was performed on safety analysis set which included participants who received any dose of CYD dengue vaccine or placebo and were analyzed according to the treatment received at this injection. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2698639|NCT01254409|Secondary|SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline|St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.|Day 1 (Baseline) and Day 57||||units on a scale||Standard Deviation|Mean
2698640|NCT01254409|Secondary|6MWT (6 Minute Walk Test) Distance Walked Change From Baseline|Change from baseline (measured during screening period) in distance walked during a 6 minute walk test|Screening (between Day -35 and Day 1) and Day 57||||meters||Standard Deviation|Mean
2698641|NCT01254409|Secondary|FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline||Day 1 (Baseline) and Day 57||||Absolute change in FEV1 % predicted||Standard Deviation|Mean
2698642|NCT01254409|Secondary|DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline||Day 1 (Baseline) and Day 57||||Absolute change in % predicted DLCO||Standard Deviation|Mean
2698643|NCT01254409|Secondary|FVC (Forced Vital Capacity) % Predicted Change From Baseline||Day 1 (Baseline) and Day 57||||absolute change in % predicted FVC||Standard Deviation|Mean
2698644|NCT01254409|Secondary|FVC (Forced Vital Capacity) Change From Baseline to Day 57||Change from Day 1 (Baseline) to Day 57||||liters||Standard Deviation|Mean
2698645|NCT01254409|Secondary|Vss|Volume of Distribution at Steady State|Day 15||||mL/kg||Full Range|Mean
2698646|NCT01254409|Secondary|Total Body Clearance||Day 15||||ml/hr/kg||Full Range|Mean
2698647|NCT01254409|Secondary|Terminal Elimination Half Life||Day 15||||hour||Full Range|Mean
2698648|NCT01254409|Secondary|AUC48|Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.|Day 15||||µg*hr/mL||Standard Deviation|Mean
2698649|NCT01254409|Secondary|Tmax|Time of Maximum observed concentration|Day 15||||hours||Standard Deviation|Mean
2698650|NCT01254409|Secondary|Cmax|Maximum concentration|Day 15|Subjects who received all doses of study treatment|||µg/mL||Standard Deviation|Mean
2698651|NCT01254409|Primary|Safety and Tolerability|Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events|From first dose on Day 1 through Day 57|All subjects who received at least one dose of study treatment|||participants|||Number
2698652|NCT01254396|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||hrs||Standard Deviation|Mean
2698653|NCT01254396|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2698654|NCT01254396|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2698655|NCT01254396|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.|||hrs||Full Range|Median
2698656|NCT01254396|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2701463|NCT01234649|Secondary|Mean Glucose During OGTT (MBG)|MBG derived from average glucose measured during OGTT in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mg/dL||Standard Deviation|Mean
2698657|NCT01254344|Secondary|Percentage of Participants With Favorable Clinical Response|Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection|4 weeks posttreatment|Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection.|||percentage of participants||95% Confidence Interval|Number
2698658|NCT01254344|Primary|Percentage of Participants With Success of Prophylaxis|Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy|From study drug dose (day of surgery) up to 4 weeks post therapy|"Primary analysis results are for evaluable-patients-only, defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents."|||percentage of participants||95% Confidence Interval|Number
2698659|NCT01254331|Secondary|Number of Participants Who Discontinued Tocilizumab||Week 52|Safety population|||participants|||Number
2698660|NCT01254331|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death||Baseline, every 4 weeks through Week 52|Safety population|||percentage of participants|||Number
2698661|NCT01254331|Secondary|Percentage of Participants Experiencing Fatigue||Baseline and Weeks 4, 8, 12, 16, 20, and 24|Safety population; n=number of participants analyzed for the given parameter at the specified visit|||percentage of participants|||Number
2698662|NCT01254331|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Levels|ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm/hour||95% Confidence Interval|Mean
2698663|NCT01254331|Secondary|Mean C-Reactive Protein (CRP) Levels|CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L).|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mg/L||95% Confidence Interval|Mean
2698664|NCT01254331|Secondary|Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)|Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||units on a scale||95% Confidence Interval|Mean
2698665|NCT01254331|Secondary|Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm||95% Confidence Interval|Mean
2698666|NCT01254331|Secondary|Assessment of Global Disease by the Participant Using VAS|"The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm||95% Confidence Interval|Mean
2698667|NCT01254331|Secondary|Assessment of Pain by the Participant Using Visual Analog Scale (VAS)|"The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to their level of pain and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm||95% Confidence Interval|Mean
2698668|NCT01254331|Secondary|SJC and TJC|28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||joints||95% Confidence Interval|Mean
2698669|NCT01254331|Secondary|Time To Achieve ACR20/ACR50/ACR70|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population|||weeks||Inter-Quartile Range|Median
2698670|NCT01254331|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population|||percentage of participants|||Number
2698671|NCT01254331|Secondary|Percentage of Participants Achieving Remission Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit|||percentage of participants|||Number
2698672|NCT01254331|Secondary|Percentage of Participants Achieving LDA Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit|||percentage of participants|||Number
2698673|NCT01254331|Secondary|Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)|DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤) 3.2 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; number (n)= number of participants analyzed at a specific visit|||percentage of participants|||Number
2698674|NCT01254318|Secondary|Percentage of Participants With Invasive Fungal Infections in Canada|Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.||||||
2698675|NCT01254318|Secondary|Percentage of Participants With a Specific Fungal Pathogen at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.|365 days|All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.|||Percentage of participants|||Number
2698676|NCT01254318|Primary|Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.|||Percentage of participants||95% Confidence Interval|Number
2698677|NCT01254305|Primary|Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score|The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.~The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."|||units on a scale||Standard Deviation|Mean
2698678|NCT01254305|Secondary|Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward|The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems—with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).|From Baseline to Week 8|The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.|||units on a scale||Standard Deviation|Mean
2698679|NCT01254305|Primary|Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score|The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.~The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."|||units on a scale||Standard Deviation|Mean
2698680|NCT01254292|Secondary|User Satisfaction - Acceptability of the Administration of Study Treatment|The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.|At 12 months|Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)|||Participants|||Number
2698812|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 2|Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.|||hours (h)||Full Range|Median
2698681|NCT01254292|Secondary|User Satisfaction - Acceptability of the Administration of Study Treatment|The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.|At 6 months|Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)|||Participants|||Number
2698682|NCT01254292|Other Pre-specified|Participants' Evaluation of Pain During IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)|||Participants|||Number
2698683|NCT01254292|Other Pre-specified|Investigator's Evaluation of IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)|||Participants|||Number
2698684|NCT01254292|Other Pre-specified|Participants' Evaluation of Pain During Successful IUS Insertion Procedure||Up to 18 months|Full analysis set|||Participants|||Number
2698685|NCT01254292|Other Pre-specified|Investigator's Evaluation of Successful IUS Insertion Procedure||Up to 18 months|Full analysis set|||Participants|||Number
2698686|NCT01254292|Other Pre-specified|Cumulative Number of Participants With Partial or Total Expulsion|Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.|Up to 18, 24, 36 months|Full analysis set|||Participants|||Number
2698687|NCT01254292|Secondary|Compliance Rate for Yasmin Pill Intake||Up to 18 months|Full analysis set|||Percentage of participants|||Number
2698688|NCT01254292|Secondary|Pearl Index (PI)|The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.|Up to 18, 24, 36 months|Full analysis set|||Pregnancies per 100 women years||95% Confidence Interval|Mean
2698689|NCT01254292|Secondary|Cumulative Drop-out Rate|The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.|Up to 6, 12, 18, 24 and 36 months|Full analysis set|||Percentage of participants|||Number
2698690|NCT01254292|Secondary|EVAPIL-R Scores at 18 Months/EOS|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)|||Scores on a scale||Standard Deviation|Mean
2698691|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)|||Scores on a scale||Standard Deviation|Mean
2698692|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)|||Scores on a scale||Standard Deviation|Mean
2698693|NCT01254292|Secondary|EVAPIL-R Scores at 6 Months|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 6 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)|||Scores on a scale||Standard Deviation|Mean
2698694|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)|||Scores on a scale||Standard Deviation|Mean
2700287|NCT01243580|Primary|Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.|3 months|Primary PK population|||ng.h/ml||Standard Deviation|Mean
2698695|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)|||Scores on a scale||Standard Deviation|Mean
2698696|NCT01254292|Secondary|User Satisfaction - Rating of Usual Menstrual Pain Intensity|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698697|NCT01254292|Secondary|User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698698|NCT01254292|Secondary|User Satisfaction - Satisfaction With Menstrual Bleeding Absence|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698699|NCT01254292|Secondary|User Satisfaction - Frequency of Experiencing Unexpected Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698700|NCT01254292|Secondary|User Satisfaction - Satisfaction With Menstrual Bleeding Pattern|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698701|NCT01254292|Secondary|User Satisfaction - Amount of Menstrual Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698702|NCT01254292|Secondary|User Satisfaction - Choices Upon Completion of the Study|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698703|NCT01254292|Secondary|User Satisfaction - Acceptability of the Administration of Study Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
2698704|NCT01254292|Secondary|Overall Satisfaction Rate at 12 Months (LOCF)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question."|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)|||Percentage of participants|||Number
2698705|NCT01254292|Secondary|Overall Satisfaction Rate at 6 Months (LOCF)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question."|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)|||Percentage of participants|||Number
2698706|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question.~The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase."|At 18 months/EOS|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)|||Percentage of participants|||Number
2698707|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 18 Months|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question."|At 18 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)|||Percentage of participants|||Number
2698813|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2|AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC 0-τ values.|||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
2698708|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 12 Months|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question."|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)|||Percentage of participants|||Number
2698709|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 6 Months|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question."|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)|||Percentage of participants|||Number
2698710|NCT01254292|Primary|Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting 1. Very satisfied or 2. Satisfied for the above question."|At 18 months|Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)|||Percentage of participants|||Number
2698711|NCT01254214|Secondary|Center for Epidemiologic Studies Depression Scale (CESD)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|baseline, 8 weeks, 26 weeks||||units on a scale||Standard Deviation|Mean
2698712|NCT01254214|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|baseline, 8 weeks, 26 weeks||||units on a scale||Standard Deviation|Mean
2698713|NCT01254214|Secondary|SF-12 PCS|Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.|baseline, 8 weeks, 26 weeks||||T scores||Standard Deviation|Mean
2698714|NCT01254214|Secondary|Short Form -12 MCS|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|baseline, 8 and 26 weeks||||T-Scores||Standard Deviation|Mean
2698715|NCT01254214|Primary|State-Trait Anxiety Inventory|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|Baseline, 8 weeks, 26 weeks||||units on a scale||Standard Deviation|Mean
2698716|NCT01254188|Secondary|Kaplan-Meier Estimates of Failure-free Survival|Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.|3,6,9,12,15,18,21,and 24 months|FAS|||percentage probability||95% Confidence Interval|Number
2698717|NCT01254188|Secondary|Kaplan-Meier Estimates of Progression-free Survival|PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.|3,6,9,12,15,18,21,and 24 months|FAS|||percentage probability||95% Confidence Interval|Number
2698718|NCT01254188|Secondary|Overall Survival|OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|3, 6, 9, 12, 15, 18, 21, 24 Months||||percentage probability||95% Confidence Interval|Number
2698719|NCT01254188|Secondary|Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.|"* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.~Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375"|6,12,18 and 24 months||||percentage of participants||95% Confidence Interval|Number
2698720|NCT01254188|Secondary|Complete Cytogenetic Response|Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.|6 months||||percentage of participants||95% Confidence Interval|Number
2698721|NCT01254188|Secondary|Duration of Major Molecular Response|Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375|3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected|Full Analysis set, Number of events / censored 29/312.|||percentage of participants||95% Confidence Interval|Number
2698722|NCT01254188|Secondary|Time to Molecular Response at 24 Months|Estimated median time to first MMR by Kaplan-Meier method|24 months|Full analysis set|||Months||95% Confidence Interval|Median
2698723|NCT01254188|Primary|The Percentage of Patients Achieving MMR by 12 Months|MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method|12 months||||percentage of participants||95% Confidence Interval|Number
2698724|NCT01254045|Secondary|Salivary Cortisol|salivary cortisol level measured immediately before social challenge task and 20 minutes following social challenge task at each time point (i.e., baseline, week 2, and week 3)|baseline, week 2, and week 3||||nmol/L||Standard Error|Mean
2701464|NCT01234649|Secondary|Fasting Blood Glucose (FBG)|Fasting glucose levels in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mg/dL||Standard Deviation|Mean
2698725|NCT01254045|Primary|Eye Contact/Gaze During 10 Minute Social Challenge Task|Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits.|baseline, week 2, and week 3||||eye contact/gaze events per 10 minutes||Standard Error|Mean
2698726|NCT01254019|Secondary|Plasma Concentrations of GSK2402968 Following Subcutaneous Administration|Blood samples for pharmacokinetic assessment were taken at Week 0 (Randomization) at 0.5, 1, 3 hours post-dose and at Week 8,12, 24, 36 and 47 at pre-dose, and between 1 and 4 hours post-dose. Data has been presented for plasma concentrations of GSK2402968 following subcutaneous administration.|Randomization (Week 0 at 0.5, 1 and 3 hours), Week 8 (pre-dose, 1-4 hours), Week 12 (pre-dose, 1-4 hours), Week 24 (pre-dose, 1-4 hours), Week 36 (pre-dose, 1-4 hours), Week 47 (pre-dose, 1-4 hours)|The Pharmacokinetic Population comprised all participants who were randomized to the study and from whom at least one blood sample was obtained for assessment of GSK2402968 concentration. Only those participants available at the specified time points were analyzed.|||Nanograms per millimeter||Full Range|Median
2698727|NCT01254019|Secondary|Number of Participants With Urinalysis Data Outside the Reference Range (>Reference Range High) at Any Visit Post- Baseline|Urine samples were collected for analysis of abnormal urine parameters. Quantitative examination included the assessment for urine albumin excretion rate, urine alpha-1-microglobulin, urine creatinine excretion-24 hour and urine protein excretion-24 hour. Only those parameters for which a value of >reference range high was reported at any visit post-Baseline is presented.|Up to Week 48|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2698728|NCT01254019|Secondary|Number of Participants With Clinical Chemistry Parameters of PCC at Any Visit Post-Baseline|Laboratory samples were collected for analysis of chemistry parameters. The PCC values for chemistry parameters for alanine amino transferase (ALT) plus total bilirubin (TB) was >=1.5 x ULN for TB and >=2 x ULN for ALT, for albumin was 0.86 x LLN, for asparatate amino transferase (AST) was >=2 x ULN, for calcium was 0.91 x LLN and 1.06 x ULN, for glucose was 0.71 x LLN and 1.41 x ULN, for phosphorus was 0.80 x LLN and 1.14 x ULN, for sodium was 0.96 x LLN and 1.03 x ULN, for potassium was 0.86 x LLN and 1.10 x ULN and that for alkaline phosphatase was >=2x ULN. Only those parameters for which a value of PCC was reported at any visit post-Baseline is presented.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2698729|NCT01254019|Secondary|Number of Participants With Coagulation Parameters of PCC at Any Visit Post-Baseline|Laboratory samples were collected for analysis of coagulation parameters. The PCC values for coagulation parameters activated partial thromboplastin time (aPTT) was 1.5 x ULN and aPTT ratio also known as international normalized ration (INR) was 1.2 x ULN. Only those parameters for which a value of PCC was reported at any visit post-Baseline is presented.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2698730|NCT01254019|Secondary|Number of Participants With Hematology Parameters of PCC at Any Visit Post-Baseline|Laboratory samples were collected for analysis of hematology parameters. The PCC values for hematology parameters: hematocrit was 1.02 x Upper limit of normal (ULN), for hemoglobin was 1.03 x ULN, for lymphocytes was 0.81 x lower limit of normal (LLN), for platelet count was 0.67 x LLN and 1.57 x ULN, for total neutrophils was 0.83 x LLN, and that for white blood cell count was 0.67 x LLN and value of 1.82 x ULN. Only those parameters for which a value of PCC was reported at any visit post-Baseline have been presented.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2698731|NCT01254019|Secondary|Number of Participants With Abnormal-clinically Significant Electrocardiogram (ECG) Findings at Any Visit Post-Baseline|ECG measurements were carried out and the clinical interpretation of the ECG by the investigator was recorded as normal, abnormal but not clinically significant and abnormal clinically significant. The PCC ranges include, QT interval corrected for heart rate by Bazett's formula (QTcB) or QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds and any increase from Baseline of QTcB or QTcF. Participants were categorized as abnormal clinically significant based on the investigator's judgment and PCC ranges. Data has been presented for number of participants with abnormal clinically significant findings at any visit post-Baseline.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2698732|NCT01254019|Secondary|Number of Participants With Vital Sign Data for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) and Heart Rate (HR) of Potential Clinical Concern (PCC) at Any Visit Post-Baseline|Blood pressure SBP, DBP and HR were recorded after five minutes of rest in a semi-supine position. The following changes from Baseline (Day 0) in vital signs were considered to be of potential clinical concern: DBP was defined as high (increase from Baseline >=20 and >=40 millimeters of mercury [mmHg] and low (decrease from Baseline >=20 and >=40 mmHg), SBP high (increase from Baseline >=10 and >=20 mmHg and low (decrease from Baseline >=10 and >=20 mmHg) and for HR high (increase from Baseline >=20 and >=40 beats per minute [bpm] and low (decrease from Baseline >=20 and >=40 bpm). Only those parameters for which a value of PCC was reported at any visit post-Baseline is presented.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2698733|NCT01254019|Secondary|Number of Participants With Adverse Events (AE) and Severe Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect.|Up to Follow-up (Week 68)|The Safety Population comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2698752|NCT01253902|Secondary|Mean Corneal Staining With Fluorescein at Week 12|Corneal staining was analyzed using the average of the scores of both eyes. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (>20 puncta) and 3=Severe (too many puncta to count).|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.|||Score on a scale||Standard Deviation|Mean
2698734|NCT01254019|Secondary|Change From Baseline in Health Utilities Index (HUI) Scores at Week 48|A 15-item HUI questionnaire assessed Health-related quality of life (HRQoL). Responses from 15-item HUI were used to quantify HRQoL according to 2 health status classification systems, HUI Mark 2 (HUI2) and HUI Mark 3 (HUI3). HUI2 assessed 7 HRQoL dimensions: sensation, mobility, emotion, cognition, self care, pain and fertility. HUI3 assessed 8 HRQoL dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Both HUI2 (range from -0.03 to 1.0) and HUI3 (range from -0.36 to 1.0) utility scores were calculated using algorithms incorporating community-derived preference weights. A utility value of 1.0 represented perfect health and a utility value of 0.0 represented death. Lowest possible HUI2 score was -0.03 and for HUI3 score was -0.36, where scores less than 0 represented health states considered worse than death. Change from Baseline was calculated by subtracting Baseline value from Week 48 value. A positive change from Baseline indicated improvement.|Baseline (Randomization Visit, Day 0) and Week 48|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2698735|NCT01254019|Secondary|Number of Participants Who Showed Improvement on Clinician Global Impression of Improvement (CGI-I) Scale at Week 48|The CGI-I is scored based on the clinician's reflection of the participant's current overall clinical condition compared to the overall clinical condition just prior to the initiation of medication use (i.e., the period prior to Randomization). The CGI-I is rated without regard to the clinician's belief that any clinical changes are or are not due to medication and without consideration of the etiology of the symptoms. The CGI-I is measured on a 7-point Likert scale (where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). The score ranged from 1-7, where lower score indicated more improvement and higher score indicated less improvement.|Week 48|ITT Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2698736|NCT01254019|Secondary|Change From Baseline in Pulmonary Function Test Peak Cough Flow (PCF) and Peak Flow (PF) at Week 48|The PF also called peak expiratory flow rate (PEFR) is a participants maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a participants ability to breathe out air. PCF was measured for participants wearing a nose clip and performing a maximum cough into a pocket peak flow meter. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters per minute||Standard Deviation|Mean
2698737|NCT01254019|Secondary|Change From Baseline in Pediatric Quality of Life (PedsQL) Total Score at Week 48|PedsQL version 3.0 scale is used to measure pediatric quality of life in children with neuromuscular disorders. The 25-item PedsQL encompasses 3 scales About My/My Childs Neuromuscular Disease (17 items), Communication (3 items), About Our Family Resources (5 items). A 5-point response scale is utilized (where 0=never a problem; 4=almost always a problem). It was assessed both by child and parent. PedsQL total score was calculated by reverse scoring individual items and linearly transforming the score to a 0-100 scale, where higher scores indicated better health-related quality of life. To reverse score individual items, the 0-4 scale items were transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score was then calculated as sum of items divided by number of items answered. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48. A positive change from Baseline indicated improvement.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the specified time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2698738|NCT01254019|Secondary|Number of Participants With Identified Mutation: DMD Exon 51 Skip (Upon Muscle Biopsies) at Week 48|Biopsies were taken from their tibialis anterior muscle and few were taken from quadriceps. Total muscle ribonucleic acid (RNA) was isolated from muscle tissue sections and was analyzed by reverse transcriptase polymer chain reaction (RT-PCR). RT-PCR analysis focused on the area flanking the targeted exon 51 was performed to detect specific exon 51 skipping in muscle. Depending on the participants mutation different sets of DMD-gene specific RT and PCR primers were used. Sequence analysis was performed on isolated PCR products to confirm specific exon 51 skip band detection.|Week 48|ITT Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2698739|NCT01254019|Secondary|Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) at Week 48|The FEV1 is the volume of air forcefully exhaled in 1 second, whereas the FVC is the volume of air that can be maximally forcefully exhaled using non-invasive spirometry was conducted to determine actual and percentage values for FVC and FEV1. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters||Standard Deviation|Mean
2698740|NCT01254019|Secondary|Change From Baseline in Creatine Kinase Serum Concentrations at Week 48|Creatine kinase is a muscle-specific enzyme; its level in serum is considered to reflect the extent of muscle damage. In the blood samples drawn to this purpose, the serum level of creatine kinase were measured. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the indicated time point were analyzed.|||International units per liter||Standard Error|Least Squares Mean
2698741|NCT01254019|Secondary|Number of Participants Who Experienced Accidental Falls During 6MWD Assessments at Week 48|The number of accidental falls occurring during the 6MWD were counted. Data has been presented for the number of participants who experienced accidental falls (from 0 to 1) during the 6MWD assessment.|Week 48|ITT Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2698742|NCT01254019|Secondary|Kaplan-Meier Estimates for Time to Loss of Ambulation|All participants were ambulant when entered into the study; however they could have become non-ambulant at some time during the study. The date was recorded and the variable time to loss of ambulation was calculated as: time to loss of ambulation = date of loss of ambulation - date of first dose. Median and interquartile range i.e. 1st and 3rd quartile is presented.|Week 48|ITT Population.|||Days||Inter-Quartile Range|Median
2698743|NCT01254019|Secondary|Change From Baseline in Muscle Strength (Total Score) at Week 48|Muscle strength was recorded by handheld myometry using a micro force evaluation testing 2 (FET2) myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. The muscle strength total score (pounds) was the sum of the 12 individual muscle strength tests. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the indicated time point were analyzed.|||Pounds||Standard Error|Least Squares Mean
2698744|NCT01254019|Secondary|Change From Baseline in the 4 Stair Climb (Descent) Velocity at Week 48|The participant was asked to descend four steps. Time was recorded with a stopwatch from the initiation of movement until the participant stood on the fourth step. A flight of steps with handrail was used for this test. Number of stairs descended per second was calculated as 4 divided by the time to descend 4 complete stairs. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the indicated time point were analyzed.|||Stairs per second||Standard Error|Least Squares Mean
2698745|NCT01254019|Secondary|Change From Baseline in the Timed Function Test Rise From Floor at Week 48|The participant stood from a standardized supine position as quickly as possible when told to go. Time was recorded with a stopwatch from the initiation of movement until the assumption of upright standing. No aids or orthoses are allowed. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the indicated time point were analyzed.|||Seconds||Standard Error|Least Squares Mean
2698746|NCT01254019|Secondary|Change From Baseline in the 10-meter Walk/Run Velocity at Week 48|The participant was instructed to perform the test bare foot. No aids or orthoses were allowed. The participant was asked to traverse a marked 10-meter measured walkway as quickly as he safely could. Time was recorded to one tenth of a second with a stop watch from when his first foot crossed the start line until when the second foot crossed the finish line. If the wall was touched, it was noted how often. Care was taken to ensure that the participant was safe when completing this test. The assessor walked nearby to provide emergency help if needed, but did not support or provide manual assistance to the participant in any way. If the participant could not complete the 10-meter walk, the total distance was recorded. 10 minute walk/run speed was equal to 10 divided by time taken to complete 10 minute walk/run. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the indicated time point were analyzed.|||Meters per second||Standard Error|Least Squares Mean
2698747|NCT01254019|Secondary|Change From Baseline in the 4 Stair Climb (Ascent) Velocity at Week 48|The participant was asked to ascend four steps. Time was recorded with a stopwatch from the initiation of movement until the participant stood on the fourth step. A flight of steps with handrail was used for this test. Number of stairs ascended per second was calculated as 4 divided by the time to ascend 4 complete stairs. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|ITT population. Only those participants available at the indicated time point were analyzed.|||Stairs per second||Standard Error|Least Squares Mean
2698748|NCT01254019|Secondary|Change From Baseline in the Linearized North Star Ambulatory Assessment (NSAA) Total Score at Week 48|The NSAA is a functional scale devised from the Hammersmith Scale of Motor Ability specifically for use in ambulant children with Duchenne muscular dystrophy (DMD). It consists of 17 activities graded 0 (unable to perform), 1 (performs with modifications), 2 (normal movement). The scale assesses activities required to remain functionally ambulant (e.g. rise from the floor), activities that can be difficult even early in the disease (e.g. standing on heels) and activities that are known to progressively deteriorate over time (stand from a chair, walk). NSAA total score was achieved by adding the responses of all activities, ranging from 0 to 34, with a score of 34 implying normal function and lower score implying more severe symptoms. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48. A positive change from Baseline indicated improvement.|Baseline (Day 0) and Week 48|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2698749|NCT01254019|Primary|Change From Baseline in Muscle Function Using the 6 Minute Walking Distance (6MWD) Test Assessed at Week 48|During the 6MWD, participants were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told that they may stop earlier if they feel unable to continue. The total distance walked within 6 minutes (or until the participant stopped in case of early termination of the test), the 6MWD, was recorded in meters as well as any falls. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.|Baseline (Day 0) and Week 48|The Intent-to-Treat (ITT) Population comprised all participants who received at least one dose of study medication and for whom at least one post-Baseline efficacy assessment was available. Only those participants available at the specified time point were analyzed.|||Meters||Standard Error|Least Squares Mean
2698750|NCT01253980|Primary|Treatment Failure|A treatment failure was a patient who at any time deteriorated necessitating a change to the treatment regimen. This was determined by assessing reported symptoms (cough, shortness of breath, wheeze and fever) and comparing clinical signs (respiratory rate, oxygen saturation, wheeze, flaring, grunting, recessions, crepitations, temperature, mental status) to signs at presentation.|At routine follow-up 3 and 5 days post-ingestion or earlier if necessary|per protocol|||participants||95% Confidence Interval|Number
2698751|NCT01253902|Secondary|Mean Tear Break Up Time (TBUT) at Week 12|Tear Break Up Time was analyzed using the average of the readings of both eyes. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.|||Seconds||Standard Deviation|Mean
2698753|NCT01253902|Primary|Mean Conjunctival Hyperemia at Week 12|Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).|Week 12|Intent-to-treat population (ITT) included all participants who were randomized to study medication.|||Score on a scale||Standard Deviation|Mean
2698754|NCT01253824|Secondary|Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||mIU･day/mL||Standard Deviation|Mean
2698755|NCT01253824|Primary|Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||ng･day/mL||Standard Deviation|Mean
2698756|NCT01253824|Secondary|Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||mIU･day/mL||Standard Deviation|Mean
2698757|NCT01253824|Primary|Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||pg･day/mL,||Standard Deviation|Mean
2698758|NCT01253811|Secondary|Rate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII.|The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period.|Weeks 0 to end of trial visit (week 173).|There were no bleeding episodes requiring treatment with a haemostatic agent (rFXIII) during the trial, which included subjects from full analysis set who received at least one dose of the trial product.||||||
2698759|NCT01253811|Secondary|Vital Signs: Pulse|Values collected for pulse from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis included all subjects who received at least one dose of the trial product.|||beats/minute||Standard Deviation|Mean
2698760|NCT01253811|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values collected for diastolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set one dose of the trial product.|||mmHg||Standard Deviation|Mean
2698761|NCT01253811|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values collected for systolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmHg||Standard Deviation|Mean
2698762|NCT01253811|Secondary|Physical Examinations|Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product. Two abnormal physical examination findings related to skin and musculo-skeletal system were assessed as clinically significant by the investigator during the trial.|||percentage of subjects|||Number
2698763|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haematocrit|Clinical laboratory values for haematocrit collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||percentage of red blood cells||Standard Deviation|Mean
2698764|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Erythrocytes|Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||10^12 cells/L||Standard Deviation|Mean
2698765|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Thrombocytes|Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||10^9 cells/L||Standard Deviation|Mean
2698766|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Leucocytes|Clinical laboratory values for leucocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||10^9 cells/L||Standard Deviation|Mean
2698767|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haemoglobin|Clinical values for haemoglobin collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmol/L||Standard Deviation|Mean
2698768|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)|Clinical laboratory assessments for ASAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||IU/L||Standard Deviation|Mean
2701465|NCT01234649|Primary|Insulin Secretion-Sensitivity Index (IS-SI)|IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET)|84 weeks of treatment||||index||Standard Deviation|Mean
2698772|NCT01253811|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.|All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors.|Week 0 to end of trial visit (week 173).|The SAS included all subjects who received at least one dose of the trial product. There were no antibodies against rFXIII detected in any patient during the trial.|||percentage of subjects|||Number
2698773|NCT01253811|Primary|Number of Treatment Emergent (Serious and Non-serious) Adverse Events|An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject's participation in the trial.|Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks.|The safety analysis set included all subjects who received at least one dose of the trial product.|||number of events|||Number
2698774|NCT01253642|Secondary|Toxicity of the Regimen|Number of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section|Up to 6 years||||Participants|||Count of Participants
2698775|NCT01253642|Secondary|Time to Death From All Causes|Time to death is calculated from Day 1 of Combination therapy to death from any cause.|Up to 6 years||||days||Full Range|Median
2698776|NCT01253642|Secondary|Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria|Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).|Up to 6 years|3 subjects were excluded from this response rate calculation as they did not have additional scans beyond baseline.|||Participants|||Count of Participants
2698777|NCT01253642|Secondary|Maximum Change in PSA|Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).|12 weeks (or earlier in patients who discontinued early)|1 subject withdrew from the study before reaching 12 weeks and is not included in this progression free survival analysis.|||percentage of PSA change||Full Range|Median
2698778|NCT01253642|Secondary|MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression|A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.|Up to 6 years|Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.||||||
2698779|NCT01253642|Secondary|HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity||Up to 6 years|Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.||||||
2698780|NCT01253642|Secondary|Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel|Reported as Number of participants with MAOA expression greater than 5%.|Baseline|Subjects who had evaluable samples collected immediately prior to initiation of Combination Therapy. 3 subjects did not have evaluable samples and were not included in this analysis.|||Participants|||Count of Participants
2698781|NCT01253642|Secondary|Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy|Progression free survival is calculated as the time from Day 1 of Combination therapy to first evidence of progression (by PSA, Measureable Disease, or Clinical Progression). For subjects who did not meet progression criteria, date of new therapy or date of death was used. Outcome is reported as mean.|Up to 6 years|1 subject withdrew from the study before the first evidence of progression and is not included in this progression free survival analysis.|||days||Full Range|Mean
2698782|NCT01253642|Primary|Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%|PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).|Within 12 weeks||||Participants|||Count of Participants
2698783|NCT01253577|Secondary|Percentage of Sinuses That Developed Frank Polyposis|Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30 days|All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.|||percentage of sinuses||95% Confidence Interval|Mean
2698784|NCT01253577|Primary|Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure|clinically significant IOP elevation is a change from baseline of >10 mm Hg on sinus side with drug-coated implant but not on side with control implant|90 days|Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points.|||percentage of patients||95% Confidence Interval|Mean
2698785|NCT01253577|Primary|Percentage of Sinuses Requiring Post-operative Intervention|Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30-days|All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.|||percentage of sinuses||95% Confidence Interval|Mean
2698786|NCT01253564|Secondary|Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status|Physician's Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit.|Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)|Safety population.|||percentage of participants||95% Confidence Interval|Number
2698814|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2|Cmax after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.|||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
2698787|NCT01253564|Secondary|Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain|VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline.|Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)|Safety population. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2698788|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic|An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population|||percentage of participants|||Number
2698789|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids|An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2698790|NCT01253564|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates.|From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)|Safety population.|||months||95% Confidence Interval|Median
2698791|NCT01253564|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason are reported.|Baseline up to end of the study and every 3 months during follow-up (up to 16 months)|Safety Population.|||percentage of participants|||Number
2698792|NCT01253564|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.|||months||95% Confidence Interval|Median
2698793|NCT01253564|Secondary|Percentage of Participants With Disease Progression or Death by Disease Site|Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.|||percentage of participants|||Number
2698794|NCT01253564|Secondary|Time to New Lesion by Disease Site|Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, ‘n’ signifies number of participants with measurable disease at baseline for specified category.|||months||95% Confidence Interval|Median
2698795|NCT01253564|Secondary|Duration of Stable Disease (SD) by Disease Site|Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category.|||months||95% Confidence Interval|Median
2698796|NCT01253564|Secondary|Time to Response by Disease Site|Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies number of participants with measurable disease for specified category.|||months||95% Confidence Interval|Median
2700288|NCT01243580|Primary|Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3.|3 months|Primary PK population|||ng.h/ml||Standard Deviation|Mean
2698797|NCT01253564|Secondary|Duration of Response by Disease Site|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)|Safety population. Here, 'n' signifies number of participants with best overall response of CR or PR for specified category.|||months||95% Confidence Interval|Median
2698798|NCT01253564|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site|Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies the number of participants with measurable disease at baseline for specified category.|||percentage of participants||95% Confidence Interval|Number
2698799|NCT01253564|Primary|Percentage of Participants With Adverse Events (AEs)|AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.|From baseline up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.|||percentage of participants|||Number
2698800|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698801|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 4|Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698802|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 4|Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698803|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4|Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698804|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698805|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698806|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 3|Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698807|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698808|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3|Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698809|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
2698810|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2|Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|Zero participants were analyzed.||||||
2698811|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 2|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.|||liters/hour (L/h)||Standard Deviation|Mean
2700289|NCT01243580|Primary|Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2698816|NCT01253525|Secondary|Ramucirumab Clearance (CL) or Cycle 1|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.|||liters/hour (L/h)||Standard Deviation|Mean
2698817|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 1|Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.|||hours (h)||Full Range|Median
2698818|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1|AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC0-∞ values.|||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
2698819|NCT01253525|Secondary|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.|Cycle 1 through Cycle 5 (28-day cycles)|All enrolled participants who received at least 1 dose of study drug and were analyzed for anti-ramucirumab (IMC-1121B) antibodies.|||percentage of participants|||Number
2698820|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1|Cmax after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.|||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
2698821|NCT01253525|Primary|Number of Participants With Serious Adverse Events (SAEs)|The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.|||participants|||Number
2698822|NCT01253525|Primary|Number of Participants With Adverse Events (AEs)|The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.|||participants|||Number
2698823|NCT01253525|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1|DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.|Cycle 1 of 28-day cycle|All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.|||participants|||Number
2698824|NCT01253460|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 8.5 years||||Months||Full Range|Median
2698825|NCT01253460|Primary|Overall Response Rate (ORR)|Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia [IWCLL] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes.|84 days||||Participants|||Count of Participants
2698826|NCT01253447|Secondary|Maximum Percentage Change in Apoptosis|Peripheral blood Acute Myeloid Leukemia (AML) cells (total 2 x 10^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response.|Baseline to 12 courses|The Assay did not work so no comparison can be made.||||||
2698827|NCT01253447|Primary|Number of Participants With Treatment-related Non-hematological Toxicity|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)|Up to 30 days post-treatment||||Participants|||Count of Participants
2698828|NCT01253447|Primary|Number of Participants With a Response of CR, CRp, or PR|Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count >/= 1.0 x10^9/L, Platelet count >/= 100 x10^9/L; Bone marrow aspirate and biopsy: </= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count >/=1.0 x10^9/L, Platelet count >/= 100 x10^9/L, >/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts </= 5% if Auer rods are present. Morphologic CR with incomplete count recovery (CRp): All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L).|12 weeks of treatment|No participant was not evaluable for response.|||participants|||Number
2698829|NCT01253421|Secondary|Effect on NAcc-MCC Connectivity After Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between nucleus accumbens (NAcc) and mid-cingulate cortex (MCC) in response to reward outcomes.|During scan session|Data missing for 8 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2701515|NCT01234103|Secondary|Self-reported Behavioral Measures Related to STI/HIV Prevention||6 to 9 months|No data were collected from participants. Participants only attended intervention sessions.||||||
2698830|NCT01253421|Secondary|Effect on Caudate-dACC Connectivity After Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between caudate and dorsal anterior cingulate cortex (dACC) in response to reward outcomes|During scan session|Data missing for 8 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2698831|NCT01253421|Primary|Effect on Putamen Response to Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation (beta) after reward outcomes. Positive values indicate an increase in activation relative to baseline.|During scan session|Data are missing for 9 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2698832|NCT01253421|Primary|Effect on NAcc Response to Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after reward outcomes. Positive values indicate an increase in activation relative to baseline.|During scan session|Data are missing for 10 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2698833|NCT01253421|Primary|Effect on Caudate Response to Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after Reward outcomes. Positive values indicate an increase in activation relative to baseline.|During scan session|Data are missing for 9 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2698834|NCT01253421|Primary|Putamen Response to Cues|This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.|Scan session|Data are missing for 9 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2698835|NCT01253421|Primary|Effect on NAcc Response to Cues|This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.|Scan session|Data are missing for 8 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
2698836|NCT01253421|Primary|Effect on Caudate Response to Cues|This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.|Scan session|Data are missing for 8 subjects due to poor MRI quality.|||Effect size (Beta)||Standard Deviation|Mean
2698837|NCT01253421|Primary|Effect on PST Penalty Learning|This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from penalties during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from penalty trials.|administered after scan|Penalty-learning results are missing for 7 subjects|||Effect size (Beta)||Standard Deviation|Mean
2698838|NCT01253421|Primary|Effect on PST Reward Learning|This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from rewards during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from reward trials.|administered after scan|Reward-learning results are missing for 7 subjects|||Effect size (Beta)||Standard Deviation|Mean
2698839|NCT01253408|Primary|Colonic Transit Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours||||units on a scale||Standard Deviation|Mean
2698840|NCT01253408|Secondary|Gastric Emptying at 2 and 4 Hours|Proportion of stomach contents emptied at a 2 and 4 hours.|2, 4 hours||||proportion of stomach contents||Standard Deviation|Mean
2698841|NCT01253408|Secondary|Ascending Colon Emptying T 1/2|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours after radiolabeled meal was ingested||||hours||Standard Deviation|Mean
2698842|NCT01253408|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours after radiolabeled meal was ingested||||percentage of meal||Standard Deviation|Mean
2698843|NCT01253408|Secondary|Gastric Emptying Half-Time (t1/2)|The time for half of the ingested solids or liquids to leave the stomach.|Approximately 2 hours after radiolabel meal is ingested||||minutes||Standard Deviation|Mean
2698844|NCT01253408|Secondary|Colonic Transit Geometric Center|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|28, 32, and 48 hours||||units on a scale||Standard Deviation|Mean
2698845|NCT01253369|Secondary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better objective response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.|||proportion of patients||80% Confidence Interval|Number
2699684|NCT01248715|Primary|Number of Participants to Transfer to ICU After 24 h|Number of subjects that were transfered to an intensive care unit (ICU) after 24 hours of hospitalization. A patient transferred to ICU within 24 hours of admission was considered as a direct admission to ICU and not meeting criteria for clinical failure.|24 h||||Participants|||Count of Participants
2698846|NCT01253369|Primary|8-Week Progression-Free Rate|The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.|For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.|||proportion of patients||80% Confidence Interval|Number
2698847|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.|||pg/mL||Standard Deviation|Mean
2698848|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.|||ul/dL||Standard Deviation|Mean
2698849|NCT01253317|Secondary|Change in Social Avoidance Subscale Scores on the ADAMS From Pre-OLE to Post-OLE|The Anxiety Depression and Mood Scale (ADAMS) is completed by the parent/caregiver and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The Social Avoidance subscale [0 = best; 20 = worst] of the ADAMS is reported as a secondary outcome measure. A negative value indicates a decrease in the Social Avoidance subscale; which represents an improved outcome.|Pre-OLE (visit 1) and post-OLE (after 20 weeks of IGF-1 therapy)|The ADAMS was not completed during the MAD.|||units on a scale||Standard Error|Mean
2698850|NCT01253317|Secondary|Change From Pre-MAD Apnea Index at Post-OLE|Apnea indices were compared from pre-MAD (prior to initiating treatment) to post-OLE (after 20 weeks of IGF-1 therapy). A negative value indicates a reduction in apnea index; representing an improved outcome. Apnea Index is defined as the number of apneas (≥ 10 seconds in length) occuring within one hour. The Apnea Index is calculated by dividing the number of qualifying apneic events by the number of hours in which they occurred. An apnea index greater than or equal to 5 is considered clinically significant by the American Academy of Sleep Medicine (AASM).|pre-MAD (baseline) to post-OLE (after 20 weeks of IGF-1 treatment)|Two subjects enrolled in the MAD did not continue participation in the OLE and one subject was excluded from the analysis because, upon further medical record review, she did not meet diagnostic criteria for Rett syndrome.|||apneas per hour||Standard Error|Mean
2698851|NCT01253317|Primary|Pharmacokinetic (PK) Profile - Areas Under the Curve (AUCt)||60 minutes pre-dose and 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 8.0, and 12.0 hours post-dose on days 1, 8, 15 and 29.||||ng.h/mL||Standard Error|Mean
2698852|NCT01253317|Primary|Adverse Events||biweekly during the MAD and every five weeks during the OLE|Subjects that had the same adverse event more than once are counted only one time using the closest relationship to study medication.|||Adverse events|||Number
2698853|NCT01253304|Primary|Pharmacokinetics: Apparent Volume of Distribution (Vz/F)|The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2698854|NCT01253304|Primary|Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)|The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2698855|NCT01253304|Primary|Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)|The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||hours||Full Range|Geometric Mean
2698856|NCT01253304|Primary|Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.|||nanograms times hr/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2698857|NCT01253304|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||nanograms times hour/milliliter(ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2698860|NCT01253291|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants with an ESR assessment at 1 or more of the specific timepoints.|||Percent Change of ESR||Standard Deviation|Mean
2698861|NCT01253291|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants with a CRP assessment at 1 or more of the specified timepoints.|||Percent Change of CRP||Standard Deviation|Mean
2698862|NCT01253291|Secondary|Percent Change From Baseline in Peripheral B-cell Subsets|Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants with Mature Naive B-Cells and Switched Memory B-Cells assessment at 1 or more of the specified timepoints.|||Percent Change of Cells||Standard Deviation|Mean
2698863|NCT01253291|Secondary|Percent Change From Baseline in CD20+ B-cell Count|CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants with CD20+ B-Cell assessment at 1 or more of the specified timepoints.|||Percent Change of cells||Standard Deviation|Mean
2698864|NCT01253291|Secondary|Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]|IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants with IgG, IgM or IgA assessment at 1 or more of the specified timepoints.|||Percent Change of Ig||Standard Deviation|Mean
2698865|NCT01253291|Secondary|Percent Change From Baseline in Rheumatoid Factor (RF)|RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants who had 1 or more RF assessment at 1 or more of the specified timepoints.|||Percent Change of RF||Standard Deviation|Mean
2698866|NCT01253291|Secondary|Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody|Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.|Baseline and Weeks 12, 24, 36, 52, and 72|All enrolled participants with an anti-CCP antibody assessment at 1 or more of the specified timepoints.|||Percent Change of Anti-CCP||Standard Deviation|Mean
2698867|NCT01253291|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.|Baseline up to 72 weeks|All enrolled participants who received at least 1 dose of study drug during BCDL.|||Participants|||Count of Participants
2698868|NCT01253265|Secondary|Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)|tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.|||days||Full Range|Median
2698869|NCT01253265|Secondary|Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)|Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2698870|NCT01253265|Secondary|Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)|AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.|||micrograms•day per milliliter(μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
2698871|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Lymphocyte Counts||Baseline, 26 weeks|All randomized participants.|||10^9 cells per liter (GI/L)||Full Range|Median
2698872|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Neutrophil Counts||Baseline, 26 weeks|All randomized participants.|||10^9 cells per liter (GI/L)||Full Range|Median
2698873|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).|Baseline, 16 weeks|All randomized participants.|||percentage change in ESR||Full Range|Median
2698874|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein|C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.|Baseline, 16 weeks|All randomized participants.|||percentage change in C-Reactive Protein||Full Range|Median
2698875|NCT01253265|Primary|Number of Participants With Clinically Significant Effects|Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline up to 26 weeks|All randomized participants.|||participants|||Number
2698876|NCT01253226|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Reference ranges are gender-specific and can vary slightly among laboratories. The normal range is approximately ≤10 millimeters per hour (mm/h) for males and ≤20 mm/h for females. Higher scores indicate greater inflammation. The percent change from baseline in ESR=[(post-baseline ESR- baseline ESR)/(baseline ESR)]*100. A decrease in ESR indicates an improvement in the participant's condition.|Baseline, Weeks 4, 8, 16, and 24|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline ESR assessment.|||percent change||Standard Deviation|Mean
2699717|NCT01248065|Secondary|Exacerbations|Outcome defined as number of exacerbations per person-year.|Overall exacerbation rate during 28-week trial||||Exacerbations/person-year||95% Confidence Interval|Number
2698877|NCT01253226|Secondary|Percent Change From Baseline in CRP|CRP is an indicator of inflammation. The percent change from baseline in CRP=[(post-baseline CRP- baseline CRP)/(baseline CRP)]*100. A negative change indicates an improvement in the participant's condition.|Baseline, Weeks 4, 8, 16, and 24|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline CRP assessment.|||percent change||Standard Deviation|Mean
2698878|NCT01253226|Secondary|Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. A negative change indicates a decrease in immunoglobulin levels.|Baseline, Weeks 4, 16, 24, and 32|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline serum immunoglobulin assessment.|||grams per liter (g/L)||Standard Deviation|Mean
2698879|NCT01253226|Secondary|Change From Baseline in Rheumatoid Factor (RF)|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis (RA). Higher RF levels indicate an aggressive RA and a higher risk of joint damage. A decrease in RF levels indicate an improvement in the participant's condition.|Baseline, Week 24|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline RF level assessment.|||kilo units per liter (kU/L)||Standard Deviation|Mean
2698880|NCT01253226|Secondary|Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method)|During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No baseline samples from the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts were analyzed using the Roche Cobas 6000 method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition.|Baseline, Week 24|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline anti-CCP assessment using the Roche Cobas 6000 method. No participants were analyzed in the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts.|||units per milliliter (U/mL)||Full Range|Median
2698881|NCT01253226|Secondary|Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method]|During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No post-baseline samples from the 120 mg tabalumab Q4W and Q2W cohorts were analyzed using the Inova ELISA method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition.|Baseline, Week 24|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline anti-CCP assessment using the Inova ELISA method. No participants were analyzed in the 120 mg tabalumab Q4W and Q2W cohorts.|||units (U)||Standard Deviation|Mean
2698882|NCT01253226|Secondary|Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts|B-lymphocyte antigen, CD20+, is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Percent change from baseline in B cell counts=[(post-baseline CD20+ B cell count-baseline CD20+ B cell count)/(baseline CD20+ B cell count)]*100. A negative change indicates a decrease in cell count.|Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline B cell assessment.|||percent change||Standard Deviation|Mean
2698883|NCT01253226|Secondary|PK of Tabalumab: Maximum Observed Drug Concentration (Cmax)|Cmax for the first SC injection of tabalumab is reported.|Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose|Randomized participants who received at least 1 dose of tabalumab and had evaluable Cmax data.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2698884|NCT01253226|Secondary|Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)|The following parameters are reported for the first SC injection of tabalumab: AUC(0-tlast) defined as AUC from time 0 to time t, where t is the time at the end of the dosing interval; AUC(0-2W) defined as AUC from time 0 to Week 2; and AUC(0-tau) defined as AUC during 1 dosing interval at steady state.|Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose|Randomized participants who received at least 1 dose of tabalumab and had evaluable AUC data.|||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2698885|NCT01253226|Primary|Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]|Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)|Randomized participants who received at least 1 dose of study drug (tabalumab or placebo).|||Participants|||Count of Participants
2698886|NCT01253200|Secondary|Chronic Success Rate: Acute Success Patients|Chronic success is defined as demonstration of acute success and freedom from recurrence of type 1 atrial flutter at 3-months post-procedure. Only randomized patients with acute procedural success will be included in this endpoint.|3-months post-procedure|The secondary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation and classified as acute success; 194 of the total 302 subjects. All consistent with approved statistical analysis plan and information publicly available in the FDA SSED and BSC the Directions for Use.|||percentage of chronic success|||Number
2698887|NCT01253200|Secondary|Chronic Success Rate: All Treated Patients|Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.|3 months post-procedure|The secondary outcome analysis is for a subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.|||percentage of subjects|||Number
2698888|NCT01253200|Primary|Acute Success Rate|Acute success is defined as demonstration of bidirectional cavo-tricuspid isthmus block (ie, lack of electrophysiological conduction through the isthmus) 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus with the investigational or control catheter only.|30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus|The primary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.|||percentage of success|||Number
2698889|NCT01253200|Primary|Procedure-related Complication-free Rate|A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.|7 days post-procedure|The primary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.|||percentage of subjects|||Number
2698890|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hours||Full Range|Median
2698891|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hours||Full Range|Median
2698892|NCT01253187|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng·h/mL||95% Confidence Interval|Geometric Mean
2698893|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hours||Full Range|Median
2698894|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol·h/L||95% Confidence Interval|Geometric Mean
2698895|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
2698896|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol·h/L||95% Confidence Interval|Geometric Mean
2698897|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
2698898|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng·h/mL||95% Confidence Interval|Geometric Mean
2699718|NCT01248065|Secondary|Lung Function Change From Baseline|FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.|Change is measured as value at 28 weeks minus baseline value.||||Liters||95% Confidence Interval|Least Squares Mean
2698899|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng/mL||95% Confidence Interval|Geometric Mean
2698900|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg·h/mL||95% Confidence Interval|Geometric Mean
2698901|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg/mL||95% Confidence Interval|Geometric Mean
2698902|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hour||Full Range|Median
2698903|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hour||95% Confidence Interval|Median
2698904|NCT01253174|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng∙h/mL||95% Confidence Interval|Geometric Mean
2698905|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hour||Full Range|Median
2698906|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol∙h/L||95% Confidence Interval|Geometric Mean
2698907|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
2698908|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol∙h/L||95% Confidence Interval|Geometric Mean
2698909|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
2698910|NCT01253174|Primary|Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng∙h/mL||95% Confidence Interval|Geometric Mean
2699732|NCT01247571|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|Time from start of treatment to time of death or the date of last contact, assessed up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2698911|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng/mL||95% Confidence Interval|Geometric Mean
2698912|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg∙h/mL||95% Confidence Interval|Geometric Mean
2698913|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg/mL||95% Confidence Interval|Geometric Mean
2698914|NCT01253148|Secondary|Overall Response Rate (ORR)|Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.|End of post treatment follow-up period of up to 20 months|All participants|||percentage of participants|||Number
2698915|NCT01253148|Secondary|Median Overall Survival (OS)|OS is defined as the duration of time from enrollment to time of death from any cause.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
2698916|NCT01253148|Primary|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|End of post treatment follow-up period of 20 months|All participants|||months||95% Confidence Interval|Median
2698917|NCT01253135|Primary|Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed)|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. The primary efficacy endpoint was analyzed, using Kaplan-Meier survival analysis, to estimate the median time to wound closure over the 21-day treatment period. Any wound which did not heal by Day 21 was censored in the analysis.|||days to closure||95% Confidence Interval|Median
2698918|NCT01253135|Primary|Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed).|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. Inter-group comparison was done using a paired Prentice-Wilcoxon method, which is applicable to censored data.|||days to wound closure||Standard Deviation|Mean
2698919|NCT01253070|Secondary|Event-free Survival|Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death or relapse (up to 10 years)||||months||95% Confidence Interval|Median
2698920|NCT01253070|Secondary|OS|OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to death (up to 10 years)||||months||95% Confidence Interval|Median
2698921|NCT01253070|Primary|Overall Survival (OS) Rate|Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.|1 year|Three participants withdrew consent to protocol treatment and follow-up prior to 1 year post registration (2 ITD; 1 TKD). These participants have been excluded from the primary endpoint analysis.|||percentage of participants||95% Confidence Interval|Number
2698922|NCT01253044|Secondary|Sheehan Disability Inventory|To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.|Baseline and week 12||||units on a scale||Standard Deviation|Mean
2698923|NCT01253044|Primary|Brief Symptom Inventory 18 (BSI-18)|To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.|Baseline and week 12||||T-score||Standard Deviation|Mean
2698933|NCT01252953|Secondary|Number of Participants With Major Vascular Event|"Major vascular events (defined as coronary death, myocardial infarction, coronary revascularization or presumed ischaemic stroke).~Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period"|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
2698924|NCT01253018|Secondary|Stroke Impact Scale: Hand Subscale|The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.|Baseline, 12 week and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 12 and the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.|||units on a scale||Standard Deviation|Mean
2698925|NCT01253018|Secondary|Wolf Motor Function Test (WMFT)|The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.|||seconds||Standard Deviation|Mean
2698926|NCT01253018|Secondary|Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)||week 12|The severity of the patients enrolled in the study were such that TMS did not evoke the number of motor action potentials needed for analysis.||||||
2698927|NCT01253018|Primary|Fugl-Meyer Motor Upper Extremity Assessment|This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. 1 participant in each group did not return for retention and were not included in the retention analysis.|||units on a scale||Standard Deviation|Mean
2698928|NCT01252966|Secondary|Cognitive Performance (Attention)|Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at Baseline were excluded as outliers.|||Change in number of commission errors||Standard Deviation|Mean
2698929|NCT01252966|Secondary|Cognitive Performance (Response Inhibition)|"Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word PRESS in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change."|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.|||Change in number of commission errors||Standard Deviation|Mean
2698930|NCT01252966|Secondary|Cognitive Performance (Working Memory)|Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.|||Change in maximum recall span||Standard Deviation|Mean
2698931|NCT01252966|Secondary|Point-prevalence Abstinence at 6-month Follow-up|Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|6 month follow-up||||Percentage of participants|||Number
2698932|NCT01252966|Primary|Point-prevalence Abstinence at End of Treatment|Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|End of treatment (Week 12)||||Percentage of participants|||Number
2698934|NCT01252953|Secondary|Number of Participants With Presumed Ischaemic Stroke|"Presumed ischaemic stroke (i.e. not known to be haemorrhagic).~Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period."|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
2698935|NCT01252953|Secondary|Number of Participants With Major Atherosclerotic Event|"Major atherosclerotic events (defined as coronary death, myocardial infarction or presumed ischaemic stroke; the key secondary outcome).~Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period."|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
2698936|NCT01252953|Primary|Number of Participants With Major Coronary Event|"Primary assessment involves an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib versus placebo on major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period.~Data reported is for the first major coronary event."|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
2698937|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 48|"The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
2698938|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 24|The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
2698939|NCT01252940|Secondary|Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
2698940|NCT01252940|Secondary|Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
2698941|NCT01252940|Secondary|Change From Baseline in Fasting HDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
2698942|NCT01252940|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
2698943|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
2698944|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 24|The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
2698945|NCT01252940|Secondary|Change From Baseline in CD4 Count Through Week 48|"The mean (SD) change in CD4 count was analyzed from baseline through Week 48.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.|||cells/mm^3||Standard Deviation|Mean
2698946|NCT01252940|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24|The mean (SD) change in CD4 count was analyzed from baseline through Week 24.|Baseline to Week 24|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.|||cells/mm^3||Standard Deviation|Mean
2698947|NCT01252940|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Week 48|Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.|||percentage of participants|||Number
2698948|NCT01252940|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.|||percentage of participants|||Number
2699733|NCT01247571|Secondary|Progression-free Survival|Progression-free survival is the period from study entry until disease progression, death or date of last contact|From start of treatment to time of progression or death, assessed up to 5 years|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2698949|NCT01252810|Secondary|Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections|Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).|2, 6 and 24 hours post Ioforminol and Iopamidol adminstration|Summary of subjects with renal biomarker-based CI-AKI by time point (Per Protocol Population).|||Subjects|||Number
2698950|NCT01252810|Secondary|To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration|"To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.~To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.~Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects."|Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.|Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.|||Number of events|||Number
2698951|NCT01252810|Primary|Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.|Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.|After the imaging date for either Ioforminol or Iopamidol.|The measured values are looking at 1) Overall Image Quality and, 2) Diagnostic Usefulness.|||Number of subjects|||Number
2698952|NCT01252745|Primary|AUC0-t of Serum Testosterone||24 hours||||ng.h/dL||Standard Deviation|Mean
2698953|NCT01252745|Primary|Cavg of Serum Testosterone||24 hours||||ng/dL||Standard Deviation|Mean
2698954|NCT01252745|Primary|Cmax of Serum Testosterone||24 hours||||ng/dL||Standard Deviation|Mean
2698955|NCT01252667|Secondary|Pharmacokinetics (PK) of Clofarabine|Pharmacokinetic measurement of the volume of plasma from which clofarabine is completely removed per unit time. Clearance normalized to actual body weight. Pharmacokinetic analyses were performed on only a subset of patients and no aggregate calculations were made using the data.|Blood was drawn on day -6 before the first clofarabine dosing, at the end of the infusion, and at 3, 4, 5, 6 and 24 hours after the start of infusion. Only pre-dose samples were drawn on days -5, -4, and -3.|Pharmacokinetic analyses were performed on only a subset of patients.|||L/h/kg|||Number
2698956|NCT01252667|Secondary|Number of Participants With Minimal Residual/Recurring Disease (MRD) Post-transplant|Number of patients with MRD post-transplant, detected in the bone marrow as cytogenetic abnormalities or <5% monoclonal blasts by flow cytometry.|1 Year post-transplant|No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. One subject on Part 2 Dose 3 aborted transplant during conditioning and subsequently expired. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2698957|NCT01252667|Secondary|Prognostic Significance of Cytogenetic and Genetic Markers|Potential prognostic markers will be assessed by polymerase chain reaction (PCR) to determine their prognostic value.|1 Year post-transplant|The studies have not been carried out on the specimens to evaluate this outcome measure.||||||
2698958|NCT01252667|Secondary|Number of Participants Who Graft Rejected.|Number of patients who graft rejected post-transplant. Graft rejection is defined as <5% donor peripheral blood T cells (CD3+).|1 Year post-transplant.|No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1. One subject on Part 2 Dose 3 aborted transplant during conditioning and subsequently expired. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2698959|NCT01252667|Secondary|Number of Non-Relapse Mortalities (NRM)|Number of patients who expired without disease progression/relapse.|100 days post-transplant|No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.|||Participants|||Count of Participants
2698960|NCT01252667|Secondary|Number of Participants Surviving Overall|Number of patients surviving overall post-transplant.|1 Year post-transplant|No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.|||Participants|||Count of Participants
2698961|NCT01252667|Secondary|Number of Participants Surviving Progression-free.|Number of patients surviving without progressive disease post-transplant. Progression is defined as the presence of >5% aberrant blasts by morphology on a marrow aspirate or the presence of circulating blasts in the peripheral blood.|1 Year post-transplant|No subjects were treated with Dose 1 or 2 in Part 2 as no DLTs were observed in Part 1.|||Participants|||Count of Participants
2698962|NCT01252667|Primary|Part 2: Number of Participants With Relapsed Disease|Number of high risk patients with relapsed disease after receiving the maximum dose of clofarabine. Relapse is defined as the presence of >5% aberrant blasts by morphology on a marrow aspirate or the presence of circulating blasts in the peripheral blood.|6 months post-transplant|Analysis only applies to subjects accrued in Part 2 of the study. Two subjects in Low Risk status and not evaluable toward this outcome. One subject aborted transplant during conditioning and subsequently expired. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2698963|NCT01252667|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLT)|"The primary objective of part 1 is to determined the highest dose of clofarabine that can be tolerated safely in conjunction with nonmyeloablative transplant. If three patients successfully transplant without DLT, dose escalation occurs. If one of those three patients experiences DLT an additional three patients will be treated using the same dose. If a second DLT is observed in the first 3-6 patients, or if three patients are successfully transplanted without DLT at the highest dose the study will proceed to Part 2 using the maximum tolerated dose.~A Clofarabine related dose-limiting toxicity is defined as a grade 4 toxicity involving the lungs, heart, liver (not resolving in 48 hours), kidneys (not resolving in 48 hours), gastrointestinal tract, and/or central nervous system."|14 days post-transplant|Analysis only applies to subjects accrued in Part 1 of the study.|||Participants|||Count of Participants
2698976|NCT01252563|Secondary|Number of Participants With Treatment-Related Adverse Events: Male vs. Female|To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events.|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Participants|||Number
2698964|NCT01252563|Secondary|Changes in Home Diastolic Blood Pressure From Baseline|Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.|4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||mmHg||Standard Deviation|Mean
2698965|NCT01252563|Secondary|Changes in Home Systolic Blood Pressure From Baseline|Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.|4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||mmHg||Standard Deviation|Mean
2698966|NCT01252563|Secondary|The Achievement Rate to Home Blood Pressure Goal|The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.|4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Percentage of participants||95% Confidence Interval|Number
2698967|NCT01252563|Secondary|Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure|To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.|Last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Participants|||Number
2698968|NCT01252563|Secondary|Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)|To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.|Last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Participants|||Number
2698969|NCT01252563|Secondary|Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)|To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.|Last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Participants|||Number
2698970|NCT01252563|Secondary|Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)|To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.|Last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Participants|||Number
2698971|NCT01252563|Secondary|Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)|To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period.|Last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Participants|||Number
2698972|NCT01252563|Secondary|Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)|To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Participants|||Number
2698973|NCT01252563|Secondary|Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)|To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Participants|||Number
2698974|NCT01252563|Secondary|Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)|To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Participants|||Number
2698975|NCT01252563|Secondary|Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)|To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Participants|||Number
2698977|NCT01252563|Secondary|Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)|To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction.|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Participants|||Number
2698978|NCT01252563|Secondary|Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||Events|||Number
2698979|NCT01252563|Secondary|Number of Participants With Adverse Events Listed in Japanese Package Insert|Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values).|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||participants|||Number
2698980|NCT01252563|Primary|Changes in Ambulatory Diastolic Blood Pressure From Baseline|Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.|4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||mmHg||Standard Deviation|Mean
2698981|NCT01252563|Primary|Changes in Ambulatory Systolic Blood Pressure From Baseline|Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.|4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||mmHg||Standard Deviation|Mean
2698982|NCT01252563|Primary|The Achievement Rate to Ambulatory Blood Pressure Goal|The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.|4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)|The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.|||Percentage of participants||95% Confidence Interval|Number
2698983|NCT01252563|Primary|Number of Participants With Treatment Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).|Last day of observation period (average of 14.76 weeks)|The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.|||participants|||Number
2698984|NCT01252355|Other Pre-specified|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: Alanine Aminotransferase (ALT) >3, 5 or 10 Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) >3, 5 or 10 ULN; Alkaline Phosphatase >1.5 ULN; Total Bilirubin (TB) >1.5 ULN; and ALT >3 ULN and TB >2 ULN.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population as previously defined but including only participants who had post-baseline values.|||participants|||Number
2698985|NCT01252355|Secondary|Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population: all randomized and treated participants. Participants were included in the treatment group according to the drug actually received.The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group.|||participants|||Number
2698986|NCT01252355|Secondary|Resource Utilization When Relapse|Resource utilization each time a participant experiences an MS relapse, specifically the number of hospitalizations, the number of over night spent in the hospital and number of intensive care admissions if hospitalized were to be reported.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
2698987|NCT01252355|Secondary|Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24|SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
2698988|NCT01252355|Secondary|Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
2699001|NCT01252277|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.|baseline to end of intervention (~6 months)|Subjects completing intervention|||ratio||Inter-Quartile Range|Median
2699734|NCT01247571|Primary|Number of Patients With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTCAE v4.|Every cycle while on treatment|Eligible and Treated Patients|||participants|||Number
2698989|NCT01252355|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72|Probability of no relapse at 24, 48 and 72 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time <=t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined.|||percent probability of no relapse||95% Confidence Interval|Number
2698990|NCT01252355|Secondary|Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, region, IFN-beta dose stratum, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 24|ITT population as previously defined but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
2698991|NCT01252355|Secondary|Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.|||milliliters per scan|||Number
2698992|NCT01252355|Secondary|Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. Probability of disability progression was to be estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
2698993|NCT01252355|Secondary|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-beta dose stratum and baseline number of Gd-enhancing T1-lesions as covariates).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.|||lesions per scan||95% Confidence Interval|Number
2698994|NCT01252355|Primary|Annualized Relapse Rate (ARR) (Poisson Regression Estimates)|"ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-beta dose stratum, and number of relapses in the year prior to randomization as covariates)."|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||relapses per patient-year||95% Confidence Interval|Number
2698995|NCT01252290|Secondary|Change in Ki-67 Expression|Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.|6 month value compared to baseline value||||change in percent Ki-67 expression||Inter-Quartile Range|Median
2698996|NCT01252290|Secondary|Change in Quality of Life|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.|Change from Baseline to Month 6||||units on a scale||Full Range|Median
2698997|NCT01252290|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.|Change from Baseline to Month 6||||ratio||Inter-Quartile Range|Median
2698998|NCT01252290|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value||||units on a scale||Inter-Quartile Range|Median
2698999|NCT01252290|Primary|The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day|To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.|6 month visit||||proportion of enrolled participants|||Number
2699000|NCT01252277|Secondary|Change in Quality of Life.|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.|duration of intervention, baseline to ~ 6 months|Subjects completing intervention|||units on a scale||Inter-Quartile Range|Median
2699003|NCT01252277|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value||||change in units on a scale||Inter-Quartile Range|Median
2699004|NCT01252277|Primary|The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day|The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.|6 month visit||||proportion of enrolled participants|||Number
2699005|NCT01252251|Secondary|Median Overall Survival (OS)||Up to 3 years||||months||Full Range|Median
2699006|NCT01252251|Secondary|Safety and Toxicity in This Patient Population.|Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, the regular monitoring of hematology (including glycosylated hemoglobin and coagulation parameters), blood chemistry (including fasting glucose, thyroid function tests, GH, IGF-1 and prolactin), urinalysis, regular monitoring of vital signs, echocardiography, ECGs, and body weight. Toxicity will be assessed using the NCI-CTC for Adverse Events, version 4.0 (CTCAEv4.0,|16 weeks||||Participants|||Count of Participants
2699007|NCT01252251|Secondary|Median Progression Free Survival(PFS)||Up to 3 years||||weeks||Full Range|Median
2699008|NCT01252251|Primary|Number of Participants With Stable Disease (SD)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks||||Participants|||Count of Participants
2699009|NCT01252251|Primary|Number of Participants With Partial Response (PR)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks||||Participants|||Count of Participants
2699010|NCT01252251|Primary|Number of Participants With Complete Response (CR)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks||||Participants|||Count of Participants
2699011|NCT01252238|Other Pre-specified|Pulse Wave Velocity|Measure of pulsewave velocity cm/s|12 weeks|Comparison of baseline vs at 12 weeks on study drug|||cm/s||Standard Error|Mean
2699012|NCT01252238|Secondary|Aortic Compliance|Characteristic aortic imedeance, dynes x s/cm5|12 weeks|Comparison of Baseline vs. study drug at 12 week2|||dyne x sec/cm5||Standard Error|Mean
2699013|NCT01252238|Primary|Change in Insulin Sensitivity by HOMA at 12 Weeks|The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value|12 weeks||||HOMA Scale||Standard Deviation|Mean
2699014|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)||Baseline to Month 6|Per-protocol population with available data|||mIU/L||Standard Error|Least Squares Mean
2699015|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin||Baseline to Month 6|Per-protocol population with available data|||nmol/L||Standard Error|Least Squares Mean
2699016|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Cortisol||Baseline to Month 6|Per-protocol population|||nmol/L||Standard Error|Least Squares Mean
2699017|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)||Baseline top Month 6|Per-protocol population with available data|||mIU/L||Standard Error|Least Squares Mean
2699018|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)|Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.|Baseline to Month 6|Per-protocol population|||ng/mL||Standard Error|Least Squares Mean
2699019|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699020|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Free Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699021|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Antigen|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699022|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Activity|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699023|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Antithrombin|"Antithrombin is a protein in the blood that naturally blocks blood clots from forming.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699752|NCT01247428|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only|8 hours||||percentage of participants||95% Confidence Interval|Number
2699024|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VIII|"Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699025|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VII|"Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation.~Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699026|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor II|Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
2699027|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)|Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.|Baseline to Month 6|Per-protocol population|||µg/L||Standard Error|Least Squares Mean
2699028|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasminogen|Plasminogen is the precursor of plasmin, which lyses fibrin clots.|Baseline to Month 6|Per-protocol population|||g/L||Standard Error|Least Squares Mean
2699029|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Fibrinogen|Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.|Baseline to Month 6|Per-protocol population|||g/L||Standard Error|Least Squares Mean
2699030|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)|"This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway.~The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC.~APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition.~APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio."|Baseline to Month 6|Per-protocol population|||ratio||Standard Error|Least Squares Mean
2699031|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)|"The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition.~APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio."|Baseline to Month 6|Per-protocol population with available data|||ratio||Standard Error|Least Squares Mean
2699032|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex|The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population|||ng/mL||Standard Error|Least Squares Mean
2699033|NCT01252186|Secondary|Change From Baseline to End of Month 6 in D-dimer|D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population|||ng/mL||Standard Error|Least Squares Mean
2699034|NCT01252186|Primary|Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.|Baseline to Month 6|Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations.|||pmol/L||Standard Error|Least Squares Mean
2699035|NCT01252147|Primary|Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Intra-rater (within raters) agreement of the GEA-J scores (1=minimum, 2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 rater who evaluated 68 subjects using GEA-J scale with photonumeric guide, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.|||Kappa statistics||95% Confidence Interval|Number
2699036|NCT01252147|Primary|Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Inter-rater agreement (among raters) of the GEA-J scores (1=minimum,2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters who scored 68 subjects' eyelashes using GEA-J Scale with photonumeric guide at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.|||Kendall's W||95% Confidence Interval|Number
2699069|NCT01251757|Secondary|Systolic Blood Pressure (SBP)|Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.|12-months post randomization|The analysis sample was restricted to ACEI/ARB users with at least one post intervention SBP measurement recorded in the EMR. We did not impute any missing data.|||mm Hg||Standard Deviation|Mean
2699037|NCT01252134|Secondary|Corneal Staining Extent|Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.|||percentage of cornea||Standard Deviation|Mean
2699038|NCT01252134|Secondary|Corneal Staining Type|Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.|||Units on a scale||Standard Deviation|Mean
2699039|NCT01252134|Secondary|Subjective Comfort|Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.|8 hours|This reporting group includes all participants who completed the study.|||Units on a scale||Standard Deviation|Mean
2699040|NCT01252134|Primary|Ex Vivo Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.|8 hours|This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.|||degrees||Standard Deviation|Mean
2699041|NCT01252095|Primary|Maximum Tolerated Dose (MTD) Based on DLT|The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.|Following first 1 month cycle|Patients had to complete cycle 1 per protocol.|||DLTs|||Number
2699042|NCT01251978|Secondary|Visual Acuity (LogMar)||12 months||||LogMar|||Number
2699043|NCT01251978|Secondary|Tumor Thickness||baseline and 1 year||||millimeters (mm)||Full Range|Mean
2699044|NCT01251978|Primary|To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.||1 year|complications were only assessed in the high dose group|||participant|||Number
2699045|NCT01251965|Secondary|Participants With a Response|Response is defined as complete remission (CR) + complete remission with incomplete blood count (CRi) + Hematologic improvement (HI). Response was to be assessed for participants who were evaluated for the Phase II portion of this study. CR is absolute neutrophil count (ANC) >/= 1x109/L and platelet count >/= 100x109/L, absence of leukemia blast cells, normal marrow differential, and complete resolution of extramedullary disease. CRi is CR but platelets are < 100x109/L or ANC is <1x109/L. HI is described by the number of individual, positively affected cell lines without the use of growth factors and/or transfusions (lasting at least 4 weeks).|Up to 1 year|The study was stopped because of a lack of satisfactory clinical benefit, and did not go on to the Phase II portion. Therefore, data were not collected for this outcome measure.||||||
2699046|NCT01251965|Primary|Maximum Tolerated Dose (MTD) of Ruxolitinib|The MTD is defined as the highest dose level at which no more than one out of six subject experiences DLT during the first cycle (28 days) of therapy.|End of first 28 day cycle||||mg|||Number
2699047|NCT01251965|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|MTD defined as highest dose level at which no more than one out of six subject experiences dose limiting toxicity (DLT) during first cycle (28 days) of therapy. A non-hematologic DLT defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria) assessed as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during first 28 days on study. Participants who received at least 80% of the originally assigned doses in the first cycle were evaluable for DLT assessment of each cohort.|End of first 28 day cycle for toxicity||||Participants|||Count of Participants
2699048|NCT01251952|Secondary|To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.|During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.|days 0 and 21 post autologous stem cell transplantation|||||||
2699049|NCT01251952|Secondary|To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.||days 0 and 21 post autologous stem cell transplantation|||||||
2699050|NCT01251952|Secondary|To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.||days 0 and 21 post autologous stem cell transplantation|||||||
2699051|NCT01251952|Primary|Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.|After drug infusion, participants will be closely monitored for at least 4 hours for side effects|Up to 21 days post transplant|||||||
2699052|NCT01251861|Other Pre-specified|Samples of the Primary Tumor Specimen Will be Retrieved for Banking and Future Analysis of the Molecular Profile of the Primary PC Tissues With Emphasis on the AR and Akt Upstream and Downstream Signaling Pathways.|Biospecimen banking for future analysis; no data to be reported|Baseline|||||||
2699053|NCT01251861|Secondary|The Association Between Prior Hormonal Therapy and PSA Response|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|All randomized patients|||Participants|||Count of Participants
2699068|NCT01251757|Secondary|Percentage With Good (<140/90 mmHg) Blood Pressure Control|Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP <140 mmHg and a mean diastolic BP < 90 mmHg.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization and who had at least one post randomization BP recorded in the EMR. Missing data were not imputed.|||percentage of subjects with good control|||Number
2699054|NCT01251861|Secondary|The Association Between Gleason Score and PSA Response|"The association between PSA response (responder vs non-responder) and Gleason score (<7, 7 vs. >7) was evaluated by logistic regression with adjustment for treatment assignment.~Based on the biopsy sample, a Gleason grade is assigned to the most predominant pattern in the biopsy and a second Gleason grade is assigned to the second most predominant pattern. The two grades will then be added together to determine the Gleason score. Gleason scores range from 2-10. The higher the Gleason score, the more aggressive the cancer is likely to be."|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|All randomized patients|||Participants|||Count of Participants
2699055|NCT01251861|Secondary|PSA Slope After Starting Bicalutamide Treatment|PSA slopes were assessed by multiple PSA values after starting bicalutamide treatment. Linear regression was used to calculate PSA slope using natural log-transformed PSA values on the time of PSA measurements for each patient.|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|Patients with follow-up PSA measurement after starting bicalutamide.|||ln(PSA)/month||Standard Deviation|Mean
2699056|NCT01251861|Secondary|PSA Slope After Randomization and Before Starting Bicalutamide|PSA slopes were assessed by multiple PSA values from randomization to starting bicalutamide treatment. Linear regression was used to calculate PSA slope using natural log-transformed PSA values on the time of PSA measurements for each patient.|After randomization and prior to starting bicalutamide|Patients with follow-up PSA measurement before starting bicalutamide.|||ln(PSA)/month||Standard Deviation|Mean
2699057|NCT01251861|Secondary|PSA Slope Prior to Randomization|PSA slopes were assessed by multiple PSA values prior to randomization. Linear regression was used to calculate PSA slope using natural log-transformed PSA values on the time of PSA measurements for each patient.|Baseline (pre-randomization)|All randomized patients|||ln(PSA)/month||Standard Deviation|Mean
2699058|NCT01251861|Secondary|Duration of PSA Response|Duration of PSA response was defined as the time from the date PSA criteria were met for complete response (CR) or partial response (PR), whichever status was recorded first, to the date of PSA progression. Patients without documented PSA progression were censored at the date of last disease assessment. Duration of PSA response is analyzed among responders (PSA CR or PR).|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|Patients with PSA response (CR or PR)|||months||95% Confidence Interval|Median
2699059|NCT01251861|Secondary|Time to PSA Nadir|Time to PSA nadir was defined as the time from randomization to the date that PSA nadir, the lowest PSA value achieved after randomization, was documented. This analysis was performed among patients whose PSA level decreased after randomization compared to baseline.|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|Only patients who received protocol therapy and had follow-up PSA level lower than baseline PSA were included.|||months||Full Range|Median
2699060|NCT01251861|Secondary|Time to PSA Progression|"Time to PSA progression was defined as the time from randomization to PSA progression or date of last disease assessment showing progression-free. Development of clinical progression is also considered as an event.~For patients (pts) who achieved a ≥ 50% decline in PSA (confirmed on two consecutive determinations taken at least 4 weeks apart), progression is defined as an increase in PSA by 50% above baseline or nadir, whichever is lowest, confirmed by a 2nd PSA rise at least two weeks later. The PSA rise must be >= 5 ng/mL.~For pts with an undetectable PSA nadir (< 0.2 ng/mL confirmed on two consecutive determinations taken at least 4 weeks apart), progression is defined as PSA ≥ 0.2 ng/mL confirmed by a 2nd PSA rise at least 2 weeks later.~For pts whose PSA has not decreased by 50%, progression is defined as an increase in PSA of ≥ 50% of baseline or nadir PSA, whichever is lowest, confirmed by a repeat PSA at least 2 weeks later. The PSA must have risen by >= 5 ng/mL"|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|All randomized patients|||months||95% Confidence Interval|Median
2699061|NCT01251861|Secondary|Proportion of Patients With PSA Response|PSA complete response (CR) is defined as a PSA <0.2 ng/mL confirmed on two consecutive additional determinations taken at least 4 weeks apart. PSA partial response (PR) is defined as a reduction in PSA ≥ 50% from baseline without evidence of progression (confirmed on two consecutive additional determinations taken at least 4 weeks apart). Either CR or PR is considered as a PSA response.|Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2699062|NCT01251861|Secondary|Proportion of Patients With PSA Decline > 85% at 44 Weeks|Proportion of patients with PSA decline > 85% at 44 weeks from baseline, defined as number of patients with PSA decline > 85% at 44 weeks from baseline divided by number of patients randomized.|44 weeks|All randomized patients are included in the analysis.|||proportion of participants||95% Confidence Interval|Number
2699063|NCT01251861|Primary|The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks|The proportion of patients with undetectable PSA level (< 0.2 ng/mL) at 44 weeks, defined as number of patients with undetectable PSA level at 44 weeks divided by number of patients randomized.|44 weeks|All randomized patients are included in this analysis.|||proportion of participants||80% Confidence Interval|Number
2699064|NCT01251770|Secondary|IV Fluid Intake||12 hours from baseline||||ml||Standard Deviation|Mean
2699065|NCT01251770|Primary|Change in Sodium Levels||Change from baseline in sodium level after 12 hours||||mEq/L||Standard Deviation|Mean
2699066|NCT01251757|Secondary|Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control|Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level <= 100 mg/dL.|12 months post randomization|All randomized participants who were taking a statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.|||percentage with controlled LDL|||Number
2699067|NCT01251757|Secondary|Post Intervention Low Density Lipoprotein (LDL) Level|We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.|12 months post randomization|All randomized participants who were taking statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.|||mg/dL||Standard Deviation|Mean
2699070|NCT01251757|Secondary|Percentage With Good (>80%) ACEI/ARB Adherence|Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization|||Percent with good adherence|||Number
2699072|NCT01251757|Primary|Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)|We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization|||mMPR expressed as a fraction||Standard Deviation|Mean
2699073|NCT01251757|Primary|Adherence to Statins|"We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window.~We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications."|12 months post randomization|All randomized participants who were taking statins at the time of randomization|||mMPR as a fraction||Standard Deviation|Mean
2699074|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699075|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.|At Month 6|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699076|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.|At Month 4|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699077|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699078|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699079|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699080|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.|At Month 6|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699081|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.|At Month 4|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699082|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699083|NCT01251744|Primary|Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)|Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||titers||95% Confidence Interval|Geometric Mean
2699084|NCT01251744|Primary|Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status|Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699085|NCT01251744|Primary|Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status|Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At Month 6|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699086|NCT01251744|Primary|Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status|Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At Month 4|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699087|NCT01251744|Primary|Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status|Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699088|NCT01251744|Primary|Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status|Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At Day 0 = study entry|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699089|NCT01251744|Primary|Concentrations of Anti-CMV IgG Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||U/mL||95% Confidence Interval|Geometric Mean
2699090|NCT01251744|Primary|Anti-CMV Tegument Protein IgG Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.|At Month 6|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||U/mL||95% Confidence Interval|Geometric Mean
2699091|NCT01251744|Primary|Concentrations of Anti-CMV Tegument Protein IgG Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.|At Month 4|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||U/mL||95% Confidence Interval|Geometric Mean
2699092|NCT01251744|Primary|Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||U/mL||95% Confidence Interval|Geometric Mean
2699093|NCT01251744|Primary|Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.|At Day 0 = study entry|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||U/mL||95% Confidence Interval|Geometric Mean
2699094|NCT01251744|Primary|CMV-specific Proliferating CD4 T Cells Frequencies|"Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).~Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values."|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||CMV-specific CD4 T cells/million T-cells||Inter-Quartile Range|Median
2699172|NCT01251536|Secondary|Deaths Till 30 Days From Last Cetuximab Administration|Deaths of all causes occuring between the signature of consent and the date of last cetuximab administration + 30 days are listed per arm. None of these fatalities were deemed related to the investigational drug.|From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.||||participants|||Number
2699095|NCT01251744|Primary|CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies|Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||CMV-specific CD4 Tcells/million T-cells||Inter-Quartile Range|Median
2699096|NCT01251744|Primary|CMV-specific CD8 T-cell Frequencies|Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||CMV-specific CD8 T cells/million T-cells||Inter-Quartile Range|Median
2699097|NCT01251744|Primary|CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies|Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||CMV-specific CD8 T cells/million Tcells||Inter-Quartile Range|Median
2699098|NCT01251744|Primary|CMV-specific CD4 T-cell Frequencies|Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||CMV-specific CD4 T cells/million T-cells||Inter-Quartile Range|Median
2699099|NCT01251744|Primary|CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies|Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||CMV-specific CD4 T cells/million T-cells||Inter-Quartile Range|Median
2699100|NCT01251744|Primary|Descriptive Statistics of the Anti-gB IgG Avidity Index|The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699101|NCT01251744|Primary|Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index|The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Percentage (avidity index)||Inter-Quartile Range|Median
2699102|NCT01251744|Primary|Anti-gB IgG Antibody Concentrations|Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||EU/mL||95% Confidence Interval|Geometric Mean
2699103|NCT01251744|Primary|Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations|Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection, with available CMV infection status of the newborn, foetus or stillbirth and with available results.|||EU/mL||95% Confidence Interval|Geometric Mean
2699104|NCT01251744|Primary|Descriptive Statistics for the Anti-CMV IgM Status|Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Participants|||Count of Participants
2699105|NCT01251744|Primary|Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics|Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.|At Month 6|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Participants|||Count of Participants
2699106|NCT01251744|Primary|Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status|Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.|At Month 4|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Participants|||Count of Participants
2699107|NCT01251744|Primary|Descriptive Statistics of the Anti-CMV IgM Status|Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Participants|||Count of Participants
2699108|NCT01251744|Primary|Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status|Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||Participants|||Count of Participants
2699109|NCT01251744|Primary|Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions|The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine and blood every month from study entry to, and including, pregnancy conclusion.|At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)|The analysis was performed on the Total Enrolled cohort, which included all pregnant subjects enrolled in this study, with available CMV infection status for their infants.|||CMV DNA copies/sample||Inter-Quartile Range|Median
2699110|NCT01251744|Primary|Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions|The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine, blood and vaginal secretions every month from study entry to, and including, pregnancy conclusion.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort, which included all pregnant women with confirmed primary CMV infection and with available CMV infection status of the newborn, foetus or stillbirth.|||CMV DNA copies/sample||Inter-Quartile Range|Median
2699111|NCT01251744|Primary|Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus||Within 10 days post-delivery (Days 0-9)|The diagnosis of CMV in the newborn was done according to the local standard of care and samples were not collected for this analysis.||||||
2699112|NCT01251744|Primary|Number of Subjects With CMV Presence in the Amniotic Fluid|Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).|Within 10 days post-delivery (Days 0-9)|The analysis was performed on the Total Enrolled cohort of Infant subjects, which included the newborns sub-group diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years and foetus sub-group, referring to infants that were stillborn or with pregnancy termination.|||Participants|||Count of Participants
2699113|NCT01251744|Primary|Number of Subjects With CMV Presence in the Urine|Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).|Within 10 days post-delivery (Days 0-9)|The analysis was performed on the newborn sub-group in the Total Enrolled cohort of Infant subjects, which included the subjects diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years.|||Participants|||Count of Participants
2699114|NCT01251744|Primary|Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection|The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.|At Month 0|The analysis was performed on the Total Enrolled cohort of Infant subjects, which included the newborns' group diagnosed with CMV infection and who had their medical records reviewed 1 month after birth and every 6 months for 2 years and foetus group, referring to infants that were stillborn or with pregnancy termination.|||Participants|||Count of Participants
2699115|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Docetaxel|Apparent volume of distribution at steady state (Vss) of Docetaxel.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||L||Geometric Coefficient of Variation|Geometric Mean
2699116|NCT01251653|Secondary|Total Clearance (CL) of Docetaxel|Total Clearance (CL) of Docetaxel from plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2699117|NCT01251653|Secondary|Cmax of Docetaxel|Maximum concentration of docetaxel in plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2699118|NCT01251653|Secondary|AUC 0-24 of Docetaxel|Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2699753|NCT01247428|Secondary|Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)|240 days||||percentage of participants||95% Confidence Interval|Number
2699119|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Gemcitabine|Apparent volume of distribution at steady state (Vss) of Gemcitabine.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||L||Geometric Coefficient of Variation|Geometric Mean
2699120|NCT01251653|Secondary|Total Clearance (CL) of Gemcitabine|Total Clearance (CL) of Gemcitabine from plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2699121|NCT01251653|Secondary|Cmax of Gemcitabine|Maximum concentration of Gemcitabine in plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2699122|NCT01251653|Secondary|AUC 0-tz of Gemcitabine|Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2699123|NCT01251653|Secondary|Cmax,ss of Afatinib|Maximum concentration of Afatinib in plasma at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2699124|NCT01251653|Secondary|Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib|Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2699125|NCT01251653|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first administration of study medication to the time of death from any cause.|From the first administration of study medication to the time of death|TS, MTD cohort|||Weeks||Inter-Quartile Range|Median
2699126|NCT01251653|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first.|From the first administration of study medication to the time of disease progression or death|TS, MTD cohort|||Weeks||Inter-Quartile Range|Median
2699127|NCT01251653|Secondary|Duration of Disease Control According to RECIST v1.1|Duration of disease control according to RECIST v1.1.|From the first administration of study medication to the time of disease progression or death|TS for patients who experienced disease control.|||Days||Standard Deviation|Mean
2699128|NCT01251653|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was the time from the first documented complete response or partial response to disease progression or death.|From the first documented complete response or partial response to the time of disease progression or death|TS for patients who experienced objective response.|||Days||Standard Deviation|Mean
2699129|NCT01251653|Secondary|Time to Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease.|6 weeks, 12 weeks and 24 weeks|TS|||Participants|||Number
2699130|NCT01251653|Secondary|Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
2699131|NCT01251653|Secondary|Disease Control According to RECIST v1.1|Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non−CR/non−PD for non−measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
2699132|NCT01251653|Secondary|Best Overall Response According to RECIST v1.1 Criteria|Best overall response (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
2699133|NCT01251653|Secondary|The Incidence and Intensity of AEs With Grading According to CTCAE.|The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
2699134|NCT01251653|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).|DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0|3 weeks|Treated Set (TS)|||Participants|||Number
2699135|NCT01251614|Secondary|Change From Baseline in the Children's Depression Inventory: Short (CDI:S)|The CDI:S is a short 10-item self-rated symptom-oriented scale used to screen for depressive symptoms. CDI:S scores range from 0 to 100, with a lower score indicating fewer depressive symptoms.|Baseline, Period A, Weeks 4, 8, and 16|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.|||units on a scale||Standard Deviation|Mean
2699136|NCT01251614|Secondary|Change From Baseline in PedsQL Over Time|The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).|Baseline, Period A, Weeks 4 and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.|||units on a scale||Standard Deviation|Mean
2699137|NCT01251614|Secondary|Time to PASI 50/75/90/100 Response in Period A|Participants who did not have a response during Period A were censored.|Period A, 16 weeks|Analysis was conducted in the intent to-treat (ITT) population.|||days||Inter-Quartile Range|Median
2699138|NCT01251614|Secondary|Percentage of Participants With CDLQI = 0 Over Time|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired and a score of 0 indicates no impairment in quality of life.|Period A, Weeks 4, 8 and 16, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|Non-responder imputation was used, the analysis was conducted in the intent to-treat (ITT) population.|||percentage of participants|||Number
2699139|NCT01251614|Secondary|Change From Baseline in CDLQI Over Time|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline, Period A, Weeks 4, and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.|||units on a scale||Standard Deviation|Mean
2699140|NCT01251614|Secondary|Percent Change From Baseline in PASI Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percent change||Standard Deviation|Mean
2699141|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 100 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699142|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 90 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699143|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 75 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 75 response is at least a 75% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699144|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 50 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 50 response is at least a 50% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699145|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) Over Time"|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.~The percentage of participants achieving a score of clear (0) is reported."|Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699146|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) or Minimal (1) Over Time"|The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.|Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699147|NCT01251614|Secondary|Time to Loss of Disease Control for Participants Who Entered Period B|"Loss of disease control was defined as a worsening of PGA scores in comparison to Week 16 of Period A by at least 2 grades after treatment withdrawal. The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. Scores range from 0 (no evidence of scaling, erythema, or plaque elevation) to 5 (very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation).~Participants who did not lose disease control in period B continued off drug into period D and were observed off-drug until they finally lost disease control or until the end of the 52 weeks of period D."|Period B (36 weeks) and Period D (52 weeks)|This analysis was conducted in the ITT population who entered period B, no imputation was used.|||days||Inter-Quartile Range|Median
2699148|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) or Minimal (1) Upon Re-Treatment in Period C"|The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over < 5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.|Period C, Week 16|Non-responder imputation was used, the analysis was conducted in the ITT population who entered Period C.|||percentage of participants|||Number
2699149|NCT01251614|Secondary|Change From Baseline in the Pediatric Quality of Life Inventory (PedsQL) Score at Week 16|The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).|Baseline and Week 16|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population; only participants with Baseline and at least one post-baseline value are included.|||units on a scale||Standard Deviation|Mean
2699150|NCT01251614|Secondary|Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) Score at Week 16|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline and Week 16|Last observation carried forward (LOCF) imputation was used, the analysis was conducted in the intent-to-treat (ITT) population; only participants with Baseline and at least one post-baseline value are included.|||units on a scale||Standard Deviation|Mean
2699151|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 100 Response at Week 16|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score at Week 16."|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percentage of participants|||Number
2699152|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 90 Response at Week 16|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score at Week 16."|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percentage of participants|||Number
2699173|NCT01251536|Secondary|Laboratory Safety Assessments|Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set).|From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.||||participants|||Number
2699153|NCT01251614|Primary|"Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared (0) or Minimal (1) at Week 16"|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:~0 (Cleared): No evidence of scaling, erythema, or plaque elevation;~1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;~2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;~3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;~4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;~5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.~The percentage of participants achieving a score of clear (0) or minimal (1) is reported."|Week 16|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
2699154|NCT01251614|Primary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in PASI score at Week 16.|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percentage of participants|||Number
2699155|NCT01251588|Secondary|Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee||Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
2699156|NCT01251588|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs)||Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
2699157|NCT01251588|Secondary|Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)||Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
2699158|NCT01251588|Secondary|Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score|The EQ-5D is a standardized instrument for use as a measure of health outcome (see the EuroQOL Website for details: www.euroqol.org). Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ Visual Analogue Scale (VAS) was used to record the respondents' self-rated health status on a vertical graduated (0-100) VAS where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'.|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 58 of the 63 microfracture-treated patients enrolled in MACI00809 completed the EQ-5D VAS Score at Week 260.|||units on a scale||Full Range|Mean
2699159|NCT01251588|Secondary|Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores|"The SF-12 is a subset of the 36-Item Short-Form Health Survey (SF-36) and includes 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are used to calculate the physical (PCS) and mental (MCS) summary component scores.~MCS and PCS are summarized as Z-scores using standard SF-12 scoring and a US population means. The Z-score indicates how many standard deviations a score is from the population mean. Higher values reflect better health. Changes from Baseline are reported."|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 55 of the 63 microfracture-treated patients enrolled in MACI00809 completed the 12-Item Short-Form Health Survey at Week 260.|||Z-score||Full Range|Mean
2699160|NCT01251588|Secondary|Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System|The Modified Cincinnati Knee Rating System is a self-assessment of the intensity of sports participation, functional limitations, and the ability to participate in different types of sports. The Modified Cincinnati Knee Rating System overall knee condition score ranges from 1 (poor) to 10 (excellent).|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the Modified Cincinnati Knee Rating System at Week 260.|||units on a scale||Full Range|Mean
2699161|NCT01251588|Secondary|Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form|"The IKDC Subjective Knee Evaluation Form is a validated knee-specific measure of symptoms, function, and sports activity that is appropriate for patients with a wide variety of knee problems. The form consists of 18 items covering the domains of symptoms, functioning during activities of daily living and sports, and current function of the knee.~The IKDC Subjective Knee Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100. The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms."|MACI00206 Baseline and Week 260|64 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the IKDC form at Week 260.|||units on a scale||Full Range|Mean
2699162|NCT01251588|Secondary|Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline and Week 260|Analysis population includes all participants who completed each KOOS subscale at Week 260.|||units on a scale||Full Range|Mean
2699242|NCT01251354|Secondary|Determination of Overall Response Rate (ORR) in This Patient Population|Overall Response Rate (ORR): Defined as the sum of CR and PR.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
2699163|NCT01251588|Secondary|Average Time to Treatment Failure|"ANALYSIS NOT DONE: The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. The number of per protocol treatment failures in each treatment group are reported here.~Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient's global assessment of their knee joint compared to Baseline was the same or worse~Physician's global assessment of the patient's knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or ACI."|Up to 260 weeks||||Participants|||Count of Participants
2699164|NCT01251588|Secondary|The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures|"Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient's global assessment of their knee joint compared to Baseline was the same or worse~Physician's global assessment of the patient's knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or ACI."|Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
2699165|NCT01251588|Secondary|Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores|A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline scores.|Up to week 260||||Participants|||Count of Participants
2699166|NCT01251588|Secondary|Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill|MRI was assessed by the independent blinded evaluators by means of consensus. The number of participants with a degree of defect fill of >50% is reported.|Week 260|all participants with an MRI at Week 260|||Participants|||Count of Participants
2699167|NCT01251588|Secondary|Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline and Week 260|Analysis population includes all participants who completed each KOOS subscale at Week 260.|||units on a scale||Full Range|Mean
2699168|NCT01251588|Primary|Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores.|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline to Week 156|The analysis population (n=128) consists of a subpopulation of participants enrolled in the SUMMIT study (n=144). 65 of 65 MACI treated patients and 57 of 63 microfracture-treated patients completed the KOOS at Week 156.|||units on a scale||Full Range|Mean
2699169|NCT01251575|Secondary|Number of Patients With Grade III-IV Acute GVHD|"Number of patients with grades III-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|100 days post-transplant|One subject aborted transplant during conditioning and was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2699170|NCT01251575|Secondary|Number of Non-Relapse Mortalities|Number of patients expired without disease progression/relapse.|100 days post-transplant|One subject aborted transplant during conditioning and was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2699171|NCT01251575|Primary|Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)|"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|100 days post-transplant||||Participants|||Count of Participants
2699257|NCT01251146|Secondary|Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6|Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2699174|NCT01251536|Secondary|Skin Toxicity (Safety)|"Treatment-emergent adverse events identified by the investigator as skin reaction or events with description skin infection or nail infection. Grading of severity was per NCI CTCAE version 4.0. All events are summarized based on the timing of occurrence per Arm in the first two rows, and worst grade per patient events are presented (following 3 rows). Grade 0 is the absence of any skin reaction and grade 3 is worst severity. All patients treated (Safety set).~Note: There were 3 deviations from arm allocation rules based on the occurrence of skin toxicity. Detailed data is available upon request."|From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.||||participants|||Number
2699175|NCT01251536|Secondary|R0 Rate (Free of Tumor After Resection for Metastatic Lesions)|Rate of patients free of tumor after surgery. Subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment (600-01-006 and 600-04-006) or after progression (100-02-002, 200-03-001, and 600-01- 038) were not considered as 'resected for metastatic lesions on study'.|Treatment + follow-up (3 years from database lock)||||Participants|||Count of Participants
2699176|NCT01251536|Secondary|Resections for Metastatic Lesions|"All patients were deemed non-resectable at baseline but some became resectable during or posttreatment.~All patients (ITT). Only those patients in whom resection of secondary lesions with curative intent was performed were considered as 'resected'. Patients resected after they started subsequent anti-cancer treatment (600-01-006 and 600-04-006) or after progression (100-02-002, 200-03-001, and 600-01-038) were not considered as 'resected for metastatic lesions on study'."|Treatment + follow-up (3 years from database lock)||||Participants|||Count of Participants
2699177|NCT01251536|Secondary|Duration of Response in Liver-limited Disease Patients|The duration of response in responding patients is defined as the time interval from the time measurement criteria are first met for CR/PR during treatment to either the first time disease progression is documented or death. Subset of responders among patients with liver-limited disease.|Treatment + follow-up (3 years from database lock)||||Months||95% Confidence Interval|Median
2699178|NCT01251536|Secondary|Duration of Response|The duration of response in responding patients is defined as the time interval from the time measurement criteria are first met for CR/PR during treatment to either the first time disease progression is documented or death. Subset of responders.|Treatment + follow-up (3 years from database lock)||||Months||95% Confidence Interval|Median
2699179|NCT01251536|Secondary|Disease Control in Patients With Liver-limited Disease|Disease control is defined as a best response on treatment (e.g. till end of treatment evaluation) of either complete response (CR), partial response (PR), or stable disease (SD) (CR + PR + SD). RECIST criteria (CT/MRI). Subset of patients with liver-limited disease.|Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.||||Participants|||Count of Participants
2699180|NCT01251536|Secondary|Disease Control|Disease control is defined as a best response on treatment (e.g. till end of treatment evaluation) of either complete response (CR), partial response (PR), or stable disease (SD) (CR + PR + SD). RECIST criteria (CT/MRI). All patients (ITT).|Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.||||Participants|||Count of Participants
2699181|NCT01251536|Secondary|Overall Response in Patients With Liver-limited Disease|Overall response is defined as the best tumor response on treatment of either complete response (CR) or partial response (PR) (CR + PR). Tumor response is based on the imaging (CT/MRI) assessments of target and non-target lesions as well as considering the occurrence of new lesions as per RECIST criteria. Subset of patients with liver-limited disease.|Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.||||Participants|||Count of Participants
2699182|NCT01251536|Secondary|Overall Response|Overall response is defined as the best tumor response on treatment of either complete response (CR) or partial response (PR) (CR + PR). Tumor response is based on the CT/MRI assessments of target and non-target lesions as well as considering the occurrence of new lesions as per RECIST criteria. All patients (ITT).|Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.||||Participants|||Count of Participants
2699183|NCT01251536|Secondary|Overall Survival (OS) Median Time for Resected Patients|"Overall survival was considered from start of treatment to death. Subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment (600-01-006 and 600-04-006) or after progression (100-02-002,~End point description:~Clinical trial results 2009-009992-36 version 1 EU-CTR publication date: Page 15 of 38 200-03-001, and 600-01-038) were not considered as 'resected for metastatic lesions on study."|Treatment + follow-up (3 years from database lock)||||Months||95% Confidence Interval|Median
2699184|NCT01251536|Secondary|Overall Survival (OS) Median Time|Overall survival was considered from start of treatment to death. All patients (ITT).|Treatment + follow-up (3 years from database lock)||||months||95% Confidence Interval|Median
2699185|NCT01251536|Secondary|Death Rates by 3 Years Follow-up|Deaths by 3 years follow-up after last cetuximab administration + 30 days. All patients (ITT).|Treatment + follow-up (3 years from database lock)||||Participants|||Count of Participants
2699186|NCT01251536|Secondary|Progression Free Survival (PFS) Time for Resected Versus Non-resected Patients (Hazard Ratio)|Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. This is the subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment or after progression on treatment were not considered as 'resected for metastatic lesions on study'. Patients were not censored at time of surgery.|Treatment + follow-up (3 years from database lock)||||Hazard ratio||95% Confidence Interval|Number
2699187|NCT01251536|Secondary|Progression Free Survival (PFS) Median Time for Resected Patients|Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. This is the subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment or after progression on treatment were not considered as 'resected for metastatic lesions on study'. Patients were not censored at time of surgery.|Treatment + follow-up (3 years from database lock)||||Months||95% Confidence Interval|Median
2699188|NCT01251536|Secondary|Progression Free Survival (PFS) Median Time|Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT).|Treatment + follow-up (3 years from database lock)|All patients for whom there was evidence they were administered any dose of cetuximab or FOLFIRI on study. For this study, the safety set includes all patients and is identical to the intention-to-treat (ITT) set.|||Months||95% Confidence Interval|Median
2699189|NCT01251536|Primary|PFS Probability Rate at 9 Months in the Dose Escalation Arm|A precise estimate (+/- 10%) of the probability of not having progression at 9 months. This measure is an estimation derived from the Kaplan-Meier algorithm and does not represent a dimple percentage of participants.|9 months||||percent probability|||Number
2699190|NCT01251393|Primary|Compulsion|"The patients answered the Minnesota Cocaine Craving Scale (Halikas et al., 1991).~INTENSITY: Evaluation of crack strength by cocaine in the previous week:~0 ---------------------------- -----10~Ranges from 0 to 10 (zero = no craving; 10 intense craving). Using a rule starting from 0, we determine the number that corresponds to the compulsion. The farther from 0 the more intense the compulsion will be.~Frequency of craving onset: How many times a day 0 time/day - check: 0 point~time/day - check: 1 point~times/day - check: 2 points~to 5 times/day - check: 3 points~6 to 10 times/day - check: 4 points 11 to 20 times/day - check: 5 points more than 20 times/day - check: 6 points~Ranges from 0 to 6 points (zero = no craving; 1-2 points: Light; 3-4 points: moderate; 5- 6: intense craving).~The sum of the points of the subscales provides the final score."|3 months|A total sample of 166 patients was evaluated during the project. Of that number, 55 did not fulfil the inclusion criteria. The main reasons for exclusion were the presence of clinical comorbidities (active hepatitis, tuberculosis under treatment and epilepsy) or psychiatric comorbidities.|||score on a scale||Standard Deviation|Mean
2699191|NCT01251380|Secondary|Mean Change From DB Baseline in the PedsQL Score (Generic Core Scores) at Each Study Visit Except Week 4|"The PedsQL is a validated quality of life questionnaire, designed for children from 2 to 18 years of age. The Generic Core Scale covers four multidimensional scales including physical, emotional, social and school aspects, with three summary scales of total scale score, physical health summary score and psychosocial health summary score.~Each generic core scale was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems).~A scale score was only calculated if at least 50% of the associated items were non-missing."|Baseline and Week 12|ITT population where n represents number of subjects with data. For Treatment Cycle 4, Week 12 was not included in the study design. Subjects who completed the study or withdrew were counted as missing at subsequent visits. PHS = pyschosocial health summary; W12 = Week 12.|||units on a scale||Standard Deviation|Mean
2699192|NCT01251380|Secondary|Mean Change From DB Baseline in the PedsQL Score (CP Module Scores) at Each Study Visit Except Week 4|"The PedsQL has a disease specific CP module that is relevant to the study population and complements the core modules.~The 35-item questionnaire encompassed 7 scales including (1) daily activities (2) school activities (3) movement and balance (4) pain and hurt (5) fatigue (6) eating activities and (7) speech and communication. A 5-point scale was utilised for parent proxy-report: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem.~Each CP score was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems).~A scale score was only calculated if at least 50% of the associated items were non-missing."|Baseline and Week 12|ITT population where n represents number of subjects with data. For Treatment Cycle 4, Week 12 was not included in the study design. Subjects who completed the study or withdrew were counted as missing at subsequent visits.|||units on a scale||Standard Deviation|Mean
2699193|NCT01251380|Secondary|Mean Change From DB Baseline in the Observational Gait Scale (OGS) Total Score of the (Most) Affected Leg|"The OGS is a measurement tool used to objectively quantify positive and negative features (impairments) of the upper motor neurone syndrome. The OGS is useful when children are too young or insufficiently cooperative for instrumented gait analysis. It is based on the Physicians Rating Scale but has some modifications to improve its sensitivity to detect changes following administration of Botulinum Toxin Type A (BTX-A).~The OGS total score was calculated as the sum of the individual question scores for Questions 1 to 7, with the highest possible score being 20. The parameters collected were: knee position in midstance, initial foot contact, foot contact at midstance, timing of heel raise, hindfoot at midstance, base of support and gait assistive devices. Higher scores indicate better gait.~The mean change from baseline (in the DB study) in the OGS total score of the (most) affected leg was derived."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
2699199|NCT01251380|Secondary|Mean Change From DB Baseline in Spasticity Angle (X) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from DB baseline was calculated."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
2701516|NCT01234103|Primary|Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies||6 to 9 months|No data were collected from participants. Participants only attended intervention sessions.||||||
2699194|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in Y Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The mean change from baseline (prior to the first injection cycle in the hamstrings) in Y was derived from the TS.~Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome).~Catch without release was graded 0 if XV1=XV3, 'unratable' spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1.~Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
2699195|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in X Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from baseline (prior to the first injection cycle in the hamstrings) was calculated."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
2699196|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV3 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV3 at fast speed was derived."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
2699197|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV1 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV1 at slow speed was derived."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
2699198|NCT01251380|Secondary|Mean Change From DB Baseline in Spasticity Grade (Y) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The mean change from baseline (in the DB study) in Y was derived from the TS.~Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome).~Catch without release was graded 0 if XV1=XV3, 'unratable' spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1.~Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
2699213|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Cadence|All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of cadence were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||steps/s||Standard Deviation|Mean
2699200|NCT01251380|Secondary|Mean Change From DB Baseline in Angle of Catch (XV3) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from DB baseline in XV3 at fast speed was derived."|DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
2699201|NCT01251380|Secondary|Mean Change From DB Baseline in Angle of Arrest (XV1) Derived From the Tardieu Scale (TS), in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from DB baseline in XV1 at slow speed was derived."|DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
2699202|NCT01251380|Secondary|Mean Goal Attainment Scale (GAS) Score|Individual goals were defined prior to treatment in each treatment period. The GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals were defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. After treatment in each treatment cycle, the GAS for each goal was rated using a defined scale (-2: Much less than expected outcome, -1: Somewhat less than expected outcome, 0: Expected outcome, 1: Somewhat more than expected outcome, and 2: Much more than expected outcome).|Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
2699203|NCT01251380|Secondary|Mean Physician's Global Assessment (PGA) Score|"Global assessment of treatment response based on changes since the first injection in the DB study. PGA Scale of the Treatment Response: Global assessment of treatment response was assessed by asking the Investigator the following question: how would you rate the response to treatment in the subject's lower limb(s) since the first injection in the DB study? Answers were made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved)."|Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4.|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
2699204|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in Upper Limb Muscle Groups) in the Mean MAS Score for All Injected Upper Limb Muscle Groups From Treatment Cycle 2 Onwards|Baseline was defined as the value obtained prior to the first injection in the upper limb(s). The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). No subjects were treated in the upper limb in Treatment Cycle 4.|Baseline and Weeks 4 and 12 of Treatment Cycles 2 and 3.|ITT population where n represents number of subjects with data. Only data from subjects injected in the upper limb muscle groups are presented. TC = Treatment Cycle.|||units on a scale||Standard Deviation|Mean
2699205|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in the MAS Score in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|Baseline was defined as the value obtained prior to the first injection in the hamstrings. The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4.|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||units on a scale||Standard Deviation|Mean
2699206|NCT01251380|Secondary|Mean Change From Baseline (in the DB Study) in the MAS Score in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|Baseline for the 'change from DB baseline' was defined as the baseline of Study 141 for all treatment cycles. The Modified Ashworth Scale (MAS) is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|DB baseline; Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|Intent-to-treat (ITT) population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively, in the OL study. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
2700290|NCT01243580|Primary|Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2699207|NCT01251380|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.|Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.|From baseline (Day 1) until end of study (Week 40) of Cycle 1 and up to Week 28 of Cycles 2 to 4.|Safety Population - all enrolled subjects. One subject received placebo in the DB study and two treatment cycles of Dysport in the OL study. However, as both Dysport treatments were outside of the ranges specified (≤7.5 U/kg in Treatment Cycle 1 and Treatment Cycle 2), the subject was excluded from the analysis (no TEAEs reported for this subject).|||participants|||Number
2699208|NCT01251367|Secondary|Use of Walking Aids/Orthoses at Baseline and Week 4|Subjects were assessed on their use of walking aids and orthoses at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW visit. Outcome measure is reported per cycle at baseline and Week 4. Number of subjects with no walking aid/orthoses were included in the 'No Walking Aid' category and number of subjects with any kind of walking aid/orthosis (including single point cane, tripod cane, ankle foot orthosis or other type of walking aid/orthosis) were combined into the 'Walking Aid' category.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Participants|||Count of Participants
2699209|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)|Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699210|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed)|Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Degrees||Standard Deviation|Mean
2699211|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)|Spasticity in the treated limb was assessed using the TS for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699212|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended)|Spasticity in the treated limb was assessed using the Tardieu Scale (TS) for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Degrees||Standard Deviation|Mean
2699228|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose|Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at Week 4 and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||millimole/L (mmol/L)||Full Range|Mean
2699214|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Step Length|All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of step length were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||m/step||Standard Deviation|Mean
2699215|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Walking Speed (WS)|All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of WS were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||metres/second (m/s)||Standard Deviation|Mean
2699216|NCT01251367|Secondary|Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL|Subjects were asked to complete the EQ-5D-5L QoL questionnaire prior to the study treatment at baseline, at Week 4 and at EOS/EW visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/ depression and scored their general health state. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems and extreme problems, rated from 1 to 5 (best to worst). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean change in pain and discomfort and VAS scores from baseline to Week 4 are reported.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699217|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)|Subjects were asked to complete the SF-36 health surveys prior to the study treatment at baseline, at Week 4 and at the EOS/EW visit. The SF-36 is a generic non preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0-100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. The mean change in the PCS and MCS from baseline to Week 4 are reported.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699218|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Lower Limb Pain|The intensity of lower limb pain in the treated limb was evaluated by the subject using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: 'no pain' (circle with no red shading and scored as 0) and 'pain as bad as it could be' (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained at baseline, Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW. The mean changes from baseline in subjects with a baseline SPIN Score >0 at Week 4 was reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699219|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended|Range of active dorsiflexion of the ankle joint of the treated limb, measured using a goniometre, both with the knee flexed (90°) and extended, was used to assess treatment response. The measurements were obtained at the end of baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Degrees||Standard Deviation|Mean
2699220|NCT01251367|Secondary|Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4|An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a nine point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The percentage of responders with a PGA score of +1 or greater are reported at Week 4.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of participants|||Number
2699229|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine|Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Micromole/L (μmol/L)||Full Range|Mean
2699221|NCT01251367|Secondary|Physician's Global Assessment (PGA) of Treatment Response at Week 4|An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a nine-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores per cycle at Week 4 were reported.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699222|NCT01251367|Secondary|Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4|Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of participants|||Number
2699223|NCT01251367|Secondary|Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of participants|||Number
2699224|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)|Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699225|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
2699226|NCT01251367|Primary|Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)|12-lead ECG tracing was performed at baseline, at Week 4 of each cycle and at EOS/EW. The 12-lead ECG recordings were performed at a paper speed of 25 millimetres/second (mm/s), recorded with the subject in a supine position after 5 minutes rest. The ECG parameters; QT Duration, QT interval corrected with Fridericia's method (QTcF), QT interval corrected with Bazett's method (QTcB), QRS duration and PR duration were recorded and outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population.|||Milliseconds (ms)||Standard Deviation|Mean
2699227|NCT01251367|Primary|Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®|Blood samples were collected at baseline, Week 4 and at EOS/EW to test for the presence of BTX-A antibodies. The number of subjects who were either NAb positive at baseline or negative at baseline but then positive following injection of Dysport® were reported.|At Week 4|Subjects who received at least one open label injection of Dysport® were included in this analysis population. In addition, the antibody analysis included subjects who had an antibody assessment at baseline and at a post baseline visit (n=343).|||Participants|||Count of Participants
2701985|NCT01230021|Secondary|Terminal Half-life (t½)|Time point when half of the maximum plasma concentration is reached.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||hours||Full Range|Mean
2699230|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)|Blood samples were taken at baseline, at Week 4, and at the EOS/EW for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||IU/L||Full Range|Mean
2699231|NCT01251367|Primary|Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets|Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Giga cells/L||Full Range|Mean
2699232|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)|Blood samples for MCV were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Femtolitres (fL)||Full Range|Mean
2699233|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)|Blood samples for MCH were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||picograms (pg)||Full Range|Mean
2699234|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Haematocrit|Blood samples for haematocrit were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of RBC in blood||Full Range|Mean
2699235|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)|Blood samples for haemoglobin and MCHC were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||grams (g)/L||Full Range|Mean
2699236|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count|Blood samples for RBC count were taken at baseline, at Week 4, and at EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Tera cells/Litre (L)||Full Range|Mean
2699237|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Heart Rate (HR)|HR was recorded at baseline and at each subsequent study visit. HR was measured with the subject in a sitting position after resting for 3 minutes. Mean change in HR from baseline at Week 4 is reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Beats per minute (bpm)||Full Range|Mean
2699238|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)|Systolic and diastolic BP were recorded at baseline and at each subsequent study visit. BP was measured with the subject in a sitting position after resting for 3 minutes. Mean change in BP from baseline at Week 4 is reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Millimetres Mercury (mmHg)||Full Range|Mean
2699239|NCT01251367|Primary|Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)|Adverse events (AEs) were monitored from the time that the subject gave informed consent to the end of the study/early withdrawal (EOS/EW). An AE was reported as a TEAE if it was not present prior to study treatment administration in Study 140, or if it was present prior to study treatment in Study 140 but the intensity increased during the treatment phase of this study. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any AE that was assessed as a hypersensitivity reaction. TEAEs, treatment related TEAEs, severe TEAEs, TEAEs leading to death, TEAEs leading to withdrawal, treatment emergent AESIs, and serious adverse events (SAEs) are summarised by treatment cycle.|Up to EOS (maximum duration of 52 weeks).|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||participants|||Number
2699240|NCT01251354|Secondary|Determination of Overall Survival in This Patient Population|Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.|2 years after the last patient enrolled|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
2699241|NCT01251354|Secondary|Determination of Duration of Response in This Patient Population|Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
2700806|NCT01239381|Secondary|Median Follow-up Time|The median follow-up time among the 39 participants still alive at the time of analysis, measured from the start of treatment until the time of analysis.|1 year|the 39 participants still alive at the time of analysis|||Months||95% Confidence Interval|Median
2699243|NCT01251354|Secondary|Determination of Progression Free Survival (PFS) in This Patient Population|Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
2699244|NCT01251354|Secondary|Determination of Time to Progression (TTP) in This Patient Population|Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
2699245|NCT01251354|Secondary|Number of Participants With Adverse Events||Up to 28 days after last dose|All Screened Population|||participants|||Number
2699246|NCT01251354|Primary|Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)|"CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.~PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|12 weeks|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
2699247|NCT01251315|Primary|Intracellular Glutathione Level|Mean intracellular glutathione level every 2 hour|6 hours|Intention-to-treat|||µmol/L||Standard Deviation|Mean
2699248|NCT01251315|Secondary|Augmentation Index|"Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis."|Baseline and 6 hours||||percentage of the central pulse pressure||Standard Deviation|Mean
2699249|NCT01251276|Secondary|Percentage of Participants With One or More Serious Adverse Experiences|A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.|Up to Month 1 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
2699250|NCT01251276|Secondary|Percentage of Participants With One or More Systemic Adverse Experiences|The percentage of participants with one or more systemic adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
2699251|NCT01251276|Secondary|Percentage of Participants With One or More Injection-site Adverse Experiences|The percentage of participants with one or more injection-site adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
2699252|NCT01251276|Secondary|Percentage of Participants Who Discontinued the Study Due to an Adverse Experience|The percentage of participants who discontinued the study due to an adverse experience was assessed.|Up to Month 7|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
2699253|NCT01251276|Secondary|Percentage of Participants With One or More Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
2699254|NCT01251276|Primary|Percentage of Seroresponders Before and After the Challenge Vaccination|A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.|Predose (Day 1) and 1 month after challenge dose (Month 1)|Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation|||Percentage of participants||95% Confidence Interval|Number
2699255|NCT01251146|Secondary|Number of Participants Compliant With Study Treatment|Participants compliant with study treatment were the participants who have completed the study treatment regimen.|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|ITT population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2699256|NCT01251146|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|Safety population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2701517|NCT01233999|Primary|Mean Digital Temperature Difference From Baseline|Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.|6 weeks||||Celsius||95% Confidence Interval|Mean
2699258|NCT01251146|Secondary|Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment|Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2699259|NCT01251146|Secondary|Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."|||ratio||Standard Deviation|Mean
2699260|NCT01251146|Secondary|Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."|||millisecond square (ms^2)||Standard Deviation|Mean
2699261|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure."|||millisecond per millimeter of mercury||Standard Deviation|Mean
2699262|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).|Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)|"Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."|||millisecond per millimeter of mercury||Standard Deviation|Mean
2699263|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699264|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699265|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699266|NCT01251120|Secondary|Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)|The CDAI is a purely clinical index to measure disease activity. The index includes swollen and tender joint counts, participant global assessment of disease activity, and evaluator global assessment of disease activity (EGA).|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2716904|NCT01121913|Secondary|Time to the Maximum Concentration (Tmax)||72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||Hours||Full Range|Median
2699267|NCT01251120|Secondary|Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria|The ACR definition of response includes tender and swollen joint counts, VAS scales for pain, participant and investigator global assessment of disease activity, participant-assessed disability using Health Assessment Questionnaire (HAQ) and acute phase response.|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699268|NCT01251120|Secondary|Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28|"The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. For this study ESR was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:~DAS28 = 0.56 × √(TJC) + 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm VAS). DAS28 ≤ 2.6 defined remission."|Month 6|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699269|NCT01251120|Secondary|Number of Hours Absent From Work|Work productivity measures include absence from work (participant reported and registries), permanent work disability (pension, participant reported and registries), presenteeism (Quantity and Quality instrument, QQ).|Baseline and 6 and 12 months|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699270|NCT01251120|Primary|Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:~DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant's global assessment of disease activity (100-mm Visual Analog Scale [VAS]). DAS28 less than/equal to (≤) 2.6 defined remission."|Month 12|Because of the limited number (n) of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
2699271|NCT01251042|Secondary|Frequency of Allogenic Blood Transfusion||Up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||percentage of participants|||Number
2699272|NCT01251042|Secondary|Mean Blood Loss Volume|Estimated blood loss during and after surgery.|After surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||ml||Full Range|Mean
2699273|NCT01251042|Secondary|Interferon Gamma (IFN-γ) Concentration|Systemic IFN-γ concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
2699274|NCT01251042|Secondary|Tumor Necrosis Factor Alpha (TNF-α) Concentration|Systemic TNF-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
2699275|NCT01251042|Secondary|Interleukin-10 (IL-10) Concentration|Systemic IL-10 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
2699276|NCT01251042|Secondary|Interleukin-8 (IL-8) Concentration|Systemic IL-8 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
2699277|NCT01251042|Secondary|Interleukin-6 (IL-6) Concentration|Systemic IL-6 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
2699278|NCT01251042|Secondary|Interleukin-1-alpha (IL-1-α) Concentration|Systemic IL-1-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
2699279|NCT01251042|Primary|Difference in Plasma Free Hemoglobin (p-Hb) Concentration|Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery|At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||g/l||Standard Deviation|Mean
2699280|NCT01251042|Secondary|Creatinine Concentration|Systemic creatinine concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||μmol/l||Standard Deviation|Mean
2699281|NCT01251042|Secondary|Potassium Concentration|Systemic potassium concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||mmol/l||Standard Deviation|Mean
2699282|NCT01251042|Secondary|Hemoglobin Concentration|Systemic hemoglobin concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||g/dl||Standard Deviation|Mean
2699283|NCT01251042|Secondary|Plasma Free Hemoglobin (p-Hb) Concentration|Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||g/l||Standard Deviation|Mean
2699297|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699284|NCT01250990|Primary|Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin|Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.|Baseline and 12 weeks|Of the 22 subjects enrolled, only subjects who completed the baseline and 12 week reverse cholesterol transport studies were included in the final outcome analysis.|||%/mol/h||95% Confidence Interval|Mean
2699285|NCT01250977|Secondary|Summary Side Effect Score at Day 28 (i.e., Week 4)|A 38-item self-report measure of the side effects associated with Donepezil (e.g., nausea) was administered to all participants at observation and testing days through Day 28. For each item, side effect severity was rated on a 4-point scale (0 = not present, 1 = mild, 2 = moderate, 3 = severe). The side effect summary score from the measure collected at Day 28 was considered the dependent measure because Day 28 is when the medication reached steady state. The side effect summary score was calculated by taking the mean score (i.e., sum of all 38 items [each item rated on a scale 0-3] divided by 38) of the measure from each participant at Day 28, adding the means, and then dividing the sum of the means by the number of participants within each group. A higher summary score indicates a higher general incidence rate and severity of side effects.|Day 28||||score on a scale||Standard Error|Mean
2699286|NCT01250977|Secondary|Change From Baseline in Smoking Behavior (i.e., Cigarettes Per Day) at Day 28 (i.e., Week 4)|At each visit, smoking rate (i.e., cigarettes per day) was assessed using standard Timeline Followback methods. Weekly averages were computed to assess group differences in changes in smoking behavior from Baseline to Day 28.|Baseline and Day 28||||cigarettes per day||Standard Error|Mean
2699287|NCT01250977|Primary|Change From Baseline in Discriminability on the Penn Continuous Performance Neurocognitive Task at Day 28 (i.e., Week 4)|Sustained attention was assessed with the Penn Continuous Performance Task (P-CPT). The primary outcome measure was the change from Baseline in discriminability (score) on the P-CPT at Day 28. The discriminability score is the mathematical difference between the total correct (i.e., true positives and correct non-responses) and incorrect (i.e., errors of commission and omission) responses to a series of stimuli presented during the P-CPT. The unit of measure is number of correct responses less the number of incorrect responses. A higher discriminability score at a single time point indicates a better performance on the P-CPT. A positive change in discriminability score between Baseline and Day 28 indicates improved performance over time. In its purest mathematical sense, the discriminability measure is a difference of difference scores and therefore is without scale limits, that is, there are no minimum or maximum values one could theoretically obtain.|Baseline and Day 28||||correct minus incorrect responses||Standard Error|Mean
2699288|NCT01250977|Primary|Change From Baseline in True Positives on the 3-Back Level of the Letter-N-Back Neurocognitive Task at Day 28 (i.e., Week 4)|Neurocognitive task performance was assessed during baseline and each testing day (Day 7, 14, 21, and 28) using computerized tasks. Working memory was assessed with the Letter-N-back task.|Baseline and Day 28||||True positive responses||Standard Error|Mean
2699289|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699290|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699291|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699292|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699293|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699294|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699295|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699296|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699298|NCT01250925|Secondary|Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events|The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.|Six weeks|Participants who completed the study visits were analyzed.|||participants|eyes||Number
2699299|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
2699300|NCT01250899|Primary|Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.|Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.|12 weeks|After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls).|||percentage of participants||95% Confidence Interval|Number
2699301|NCT01250873|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Sertraline|Tmax of sertraline was determined using the median of paired differences between the 2 treatment groups when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The 90% confidence interval (CI) for the median of differences was calculated.|0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hours||90% Confidence Interval|Median
2699302|NCT01250873|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Sertraline|The Least Squares (LS) geometric mean Cmax of sertraline was determined when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The Day 13-to-Day 10 ratio of the sertraline LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.|0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Geometric Least Squares Mean
2699303|NCT01250873|Primary|Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of Sertraline|The Least Squares (LS) geometric mean AUCτ of sertraline was calculated based on the sertraline plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The Day 13-to-Day 10 ratio of the sertraline LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.|0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hour*nanogram per milliliter (h*ng/mL)||90% Confidence Interval|Geometric Least Squares Mean
2699304|NCT01250873|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684|Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The 90% confidence interval (CI) for the median of differences was calculated.|0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hours||90% Confidence Interval|Median
2699305|NCT01250873|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684|The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The Day 13-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.|0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Geometric Least Squares Mean
2699306|NCT01250873|Primary|Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684|The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when LY221684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The Day 13-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.|0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hour*nanogram per milliliter (h*ng/mL)||90% Confidence Interval|Geometric Least Squares Mean
2699307|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2699308|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2699309|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.|Pre-dose to 56 hours post-dose|No participants were analyzed for this outcome measure since the terminal elimination phase was not determinable.||||||
2699310|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2699311|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2699312|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2699313|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699314|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699315|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699316|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699317|NCT01250769|Secondary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||ug/mL||95% Confidence Interval|Least Squares Mean
2699318|NCT01250769|Primary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||ug/mL||95% Confidence Interval|Least Squares Mean
2699319|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.|||Percentage of participants|||Number
2699320|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.|||Percentage of participants|||Number
2699321|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.|||Percentage of participants|||Number
2699322|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
2699323|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
2699324|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
2699325|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
2699326|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.|||Percentage of participants|||Number
2699327|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.|||Percentage of participants|||Number
2699328|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.|||Percentage of participants|||Number
2699329|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
2699330|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
2699339|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2699331|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
2699332|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
2699333|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2699334|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2699335|NCT01250756|Secondary|Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose|Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Pre-toddler dose, 1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||Fold Rise||95% Confidence Interval|Geometric Mean
2699336|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2699337|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2699338|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
2699353|NCT01250730|Primary|Dose Normalized Cmax of Crizotinib|Dose normalized (to 150 mg dose) Cmax is obtained from Cmax / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Standard Deviation|Geometric Mean
2717845|NCT01116882|Secondary|All Cause Mortality at 30 Days||30 days|The denominator for MACE at 30 days is defined as patients who either died to 30d or had follow up of at least 23 days.|||participants|||Number
2699340|NCT01250756|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2699341|NCT01250756|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2699342|NCT01250756|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2699343|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
2699344|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series|Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2699345|NCT01250756|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2699346|NCT01250730|Primary|Metabolite to Parent Ratio Cmax|The metabolic ratio (MR) is calculated by first converting the Cmax for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ratio||Standard Deviation|Geometric Mean
2699347|NCT01250730|Primary|Metabolite to Parent Ratio AUClast|The metabolic ratio (MR) is calculated by first converting the AUClast for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ratio||Standard Deviation|Geometric Mean
2699348|NCT01250730|Primary|Metabolite to Parent Ratio AUC(0-inf)|The metabolic ratio (MR) is calculated by first converting the AUC(0-inf) for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ratio||Standard Deviation|Geometric Mean
2699349|NCT01250730|Primary|Time to Cmax (Tmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Full Range|Median
2699350|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Standard Deviation|Geometric Mean
2699351|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Plasma Active Metabolite (PF-06260182)|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
2699352|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUC0-inf) of Plasma Active Metabolite (PF-06260182)|"AUC(0-inf) of PF-06260182 is estimated from the PF-06260182 concentration. It is obtained from AUClast plus (Clast/kel).~AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.~Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
2699361|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Crizotinib|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
2699362|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib|"AUC(0-inf) of crizotinib is estimated from the crizotinib concentration. It is obtained from AUClast plus (Clast/kel).~AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.~Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
2699363|NCT01250717|Primary|Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists|One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.|status post prostectomy||||participants|||Number
2699364|NCT01250509|Secondary|Change in Psychological Stress (Baseline and 4 Months)|The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.|Change from Baseline in Psychological Stress|An intention-to-treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.|||units on a scale||Standard Deviation|Mean
2699365|NCT01250509|Secondary|Telomerase Activity|Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).|Change from Baseline in Telomerase Activity at 4 months|Intention-to-treat analysis was conducted.|||Standard arbitrary units, see above||Standard Deviation|Mean
2699366|NCT01250509|Secondary|Weight||Change in Weight (baseline and 4 months)|Intention to treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.|||kg||Standard Deviation|Mean
2699367|NCT01250509|Primary|Change in Abdominal Fat|Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.|Change from Baseline in Abdominal Fat (baseline and 4 months)|Intent-to-treat analyses were conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.|||grams||Standard Deviation|Mean
2699368|NCT01250418|Primary|TcCO2 Above 50|% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.|Intraoperative, an average of about 1 and 1/2 hours.||||Percent time intraoperatrive||Standard Deviation|Mean
2699369|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2699370|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 18|ITT population|||percentage of participants||95% Confidence Interval|Number
2699394|NCT01250379|Primary|Second-Line PFS|The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population|||months||95% Confidence Interval|Median
2699371|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 12|ITT population|||percentage of participants||95% Confidence Interval|Number
2699372|NCT01250379|Secondary|Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)|"The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.|||score on a scale||95% Confidence Interval|Mean
2699373|NCT01250379|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)|"The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.|||score on a scale||95% Confidence Interval|Mean
2699374|NCT01250379|Secondary|Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.|||mm||95% Confidence Interval|Mean
2699375|NCT01250379|Secondary|Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population; n=number of participants who completed the assessment at the specified timepoint.|||mm||95% Confidence Interval|Mean
2699376|NCT01250379|Secondary|Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)|"The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life."|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.|||score on a scale||95% Confidence Interval|Mean
2699377|NCT01250379|Secondary|Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)|"The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems)."|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint|||score on a scale||95% Confidence Interval|Mean
2717846|NCT01116882|Primary|12-month Composite Major Adverse Cardiac Event (MACE)||12 month||||participants|||Number
2699378|NCT01250379|Secondary|Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)|"The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility (M) (no problems=I have no problems in walking about to extreme problems=I am confined to bed), self-care (SC) (no problems=I have no problems with self-care to extreme problems=I am unable to wash or dress myself), usual activities (UA) (no problems=I have no problems performing my usual activities to extreme problems=I am unable to perform my usual activities), pain/discomfort (P/D) (no problems=I have no pain or discomfort to extreme problems=I have extreme pain or discomfort), and anxiety/depression (A/D) (no problems=I am not anxious or depressed to extreme problems='I am extremely anxious or depressed)."|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.|||percentage of participants|||Number
2699379|NCT01250379|Secondary|Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.|Months 6, 12, 18, and 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2699380|NCT01250379|Secondary|Overall Survival (OS)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.|Baseline until death (up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
2699381|NCT01250379|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason were reported.|Baseline until death (up to approximately 4 years)|ITT population|||percentage of participants|||Number
2699382|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 6|ITT population|||percentage of participants||95% Confidence Interval|Number
2699383|NCT01250379|Secondary|Time to Second- and Third-Line Tumor Progression|The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||months||95% Confidence Interval|Median
2699384|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line Tumor Progression|Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||percentage of participants|||Number
2699385|NCT01250379|Secondary|Second- and Third-Line PFS|The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||months||95% Confidence Interval|Median
2699386|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1|Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||percentage of participants|||Number
2699387|NCT01250379|Secondary|Third-Line PFS|The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)|Third line ITT population|||months||95% Confidence Interval|Median
2718451|NCT01112059|Primary|Number of Adverse Events|Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)|1 month from enrollment||||adverse events|||Number
2699388|NCT01250379|Secondary|Percentage of Participants With Third-Line PFS According to RECIST v1.1|Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)|Third line ITT population: all randomized participants who received third-line treatment.|||percentage of participants|||Number
2699389|NCT01250379|Secondary|Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)|Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Months 3, 6, and 9|ITT population; only randomized participants with a CR or PR were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2699390|NCT01250379|Secondary|Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)|The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with a CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2699391|NCT01250379|Secondary|Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2699392|NCT01250379|Secondary|Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)|BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2699393|NCT01250379|Secondary|Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)|The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (>) 1.5 ULN, < 65 years of age, ≥ 65 years of age, < 70 years of age, ≥ 70 years of age, < 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free > 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free > 24 months, D-free ≤ 12 months, and D-free > 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.|||months||95% Confidence Interval|Median
2701684|NCT01232504|Secondary|Hemorrhage Related Mortality|Hemorrhage related mortality after a median follow-up of 600 days|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
2699395|NCT01250379|Primary|Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)|Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|Intent-to-Treat (ITT) population - all randomized participants.|||percentage of participants|||Number
2699396|NCT01250210|Primary|Cycle Control|The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.|3 months|ITT population|||number of episodes||Standard Deviation|Mean
2699397|NCT01250210|Primary|Ovulation Suppression in Three Treatment Groups Over 3 Cycles|"Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are:~Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points.~Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points.~Perfect compliance: If no patch has been off >1 day and no more than 1 day has elapsed between patch changes.~Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit."|3 months|ITT, perfect compliance, complete progesterone, verifiable compliance|||%of cycles with possible ovulation|Total number of cycles||Number
2699398|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|12 weeks||||units on a scale||Standard Deviation|Mean
2699399|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|12 weeks||||units on a scale||Standard Deviation|Mean
2699400|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|12 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"|||units on a scale||Standard Deviation|Mean
2699401|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|4 weeks||||units on a scale||Standard Deviation|Mean
2699402|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|4 weeks||||units on a scale||Standard Deviation|Mean
2699403|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|4 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"|||units on a scale||Standard Deviation|Mean
2699412|NCT01250145|Secondary|Part B - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Days 1 - 19 and 34 - 37|All randomized participants who received a patch.|||patches with adhesive score|Participants||Number
2699404|NCT01250171|Secondary|Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were taken in a standing position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance specific to the test charts. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Standard Deviation|Mean
2699405|NCT01250171|Secondary|Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8|Patients were instructed to record each occurrence of a desire for topical lubricant use in a patient diary. The percentage of patients in each of 6 categories (0-5, 6-10, 11-15, 16-20, 21-25, > 25 times) indicating the number of times a patient records a desire for artificial tear use per day was calculated at each time point. The percentage was calculated using the number of patients with any reported data on that day in the respective treatment group as the denominator.|Day 1 and Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Percentage of patients|||Number
2699406|NCT01250171|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8|The OSDI is an instrument for measuring dry eye disease severity and effect on vision-related functions. Patients were asked a series of 12 questions; patients responded to the questions in regard to both eyes. Responses ranged from 0=None of the time to 4=All of the time. OSDI was calculated as the sum of the 12 question scores x 25/number of questions answered. The total score ranged from 0-100. A higher score indicates drier eyes. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Full Range|Mean
2699407|NCT01250171|Secondary|Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8|Conjunctival redness was measured in the study eye at each visit by a masked evaluator. The evaluator compared the patient's study eye with a set of 5 reference photos showing a normal eye and eyes with various degrees of redness. Redness was scored on a scale of 0-5 with a white normal eye = 0 and an eye with the most redness = 5. A higher score indicates more redness. A negative change score indicates improvement in redness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Full Range|Mean
2699408|NCT01250171|Secondary|Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8|Tear film breakup time was defined as the time of last blink to the appearance of the first growing micelle after instilling 5 μl of non-preserved 2% sodium fluorescein into the lower palpebral conjunctiva of the study eye. Measurement was repeated 3 times and a mean tear film breakup time calculated. A lower score indicates a drier eye. A positive change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Seconds||Full Range|Mean
2699409|NCT01250171|Secondary|Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8|The Schirmer test measures the production of tears. A small strip of filter paper is placed inside the lower eyelid (conjunctival sac) of each eye and the eyes are kept closed for 5 minutes. The paper is removed and the length of paper that is wet is measured as an index of tear production. The amount of tear production in the study eye was ranked on a 4 point scale: 0=Normal (≥ 15 mm wetting of the paper), 1=Mild (14-9 mm wetting of the paper), 2=Moderate (8-4 mm wetting of the paper), and 3=Severe (< 4 mm wetting of the paper). A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Full Range|Mean
2699410|NCT01250171|Secondary|Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of the study eye. Staining was assessed in 3 regions (inferior, superior, and central) of the cornea and rated on a scale of 0 (no staining) to 4 (confluent staining). A mean of the 3 zones was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Standard Deviation|Mean
2699411|NCT01250171|Primary|Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Week 4|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Standard Deviation|Mean
2699468|NCT01249625|Secondary|Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Detected Respiratory Infections|Number of lab detected respiratory infections in healthcare practitioners wearing N95 respirators compared to medical masks.|60 weeks||||number of respiratory infections|||Number
2699413|NCT01250145|Primary|Part B - Skin Irritation and Sensitization by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).|Days 1 - 19 and 34 - 37|All participants who entered the study and received patches are included in the analysis.|||patches with Draize scores|Participants||Number
2699414|NCT01250145|Secondary|Part A - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Day 1 through Day 22|All randomized participants who received a patch.|||patches with adhesive score|Participants||Number
2699415|NCT01250145|Primary|Part A - Cumulative Skin Irritation by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter [mm]).|Day 1 through Day 22|All participants who entered the study and received patches are included in the analysis.|||patches with Draize scores|Participants||Number
2699416|NCT01250119|Secondary|Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2699417|NCT01250119|Secondary|Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2699418|NCT01250119|Secondary|Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2699419|NCT01250119|Secondary|Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2699420|NCT01250119|Secondary|Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed at for the given parameter at the specified visit.|||percentage of participants|||Number
2699421|NCT01250119|Secondary|Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument|The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.|Screening, Baseline and Final or Withdrawal Visit up to 34 months|ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
2699422|NCT01250119|Secondary|Survival Time in Months|Duration of time in months from Screening until Death due to any cause.|Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population|||months||95% Confidence Interval|Median
2699423|NCT01250119|Secondary|Probability of Being Alive and Free of Progression by Timepoint|Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.|Months 0, 3, 6, 9, 12, 15, and 18|ITT population|||probability of being alive||95% Confidence Interval|Number
2699424|NCT01250119|Primary|Percentage of Participants With EGFR Mutations by Subgroup|Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.|14 Days|Only participants with a valid EGFR mutations test result were included in the analysis.|||percentage of participants|||Number
2699425|NCT01250119|Secondary|Percentage of Participants With a Response by Best Objective Tumor Response|"Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months|Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment.|||percentage of participants|||Number
2699426|NCT01250119|Primary|Percentage of Participants Who Tested Positive for EGFR Mutations|All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.|14 days|Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis.|||percentage of participants|||Number
2699427|NCT01250054|Primary|Overall Vision|Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.|One week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
2699428|NCT01250002|Secondary|Opioid Consumption (Morphine Equivalents)|opioid consumption (morphine equivalents)post operatively|24 hours||||mg||Full Range|Median
2699429|NCT01250002|Primary|Quality of Recovery 40 Score|Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).|24 hours post surgery|Intent to treat.|||units on a scale||Full Range|Median
2699430|NCT01249872|Secondary|Change From Baseline of Spirometric Values|Preoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.|up to 6th day postoperatively||||percentage of preoperative values||Standard Deviation|Mean
2699431|NCT01249872|Secondary|Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively|Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.|up to 48 hours postoperatively||||mg||Standard Deviation|Mean
2699432|NCT01249872|Secondary|Consumption of Levobupivacaine at 24h and 48 h Postoperatively|Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively|up to 48 hours postoperatively||||mg||Standard Deviation|Mean
2699433|NCT01249872|Secondary|Time to First Postoperative Ambulation|Time to being able to walk without assistance within the room or outside the room|up to 6 days||||hours||Standard Deviation|Mean
2699434|NCT01249872|Secondary|Time to Postoperative Bowel Recovery|Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient|up to 6 days||||hours||Standard Deviation|Mean
2699435|NCT01249872|Primary|Change From Baseline in Pain Scores (Visual Analogue Scale)|Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.|up to 48 h postoperatively|The sample size was chosen in order to detect a difference in the epidural levobupivacaine PCEA consumption at 48 hrs. We calculated that 14 patients per group would be adequate to detect statistical significance (α = 0.05, power = 90%), using data from a previous pilot study Then, we increased the sample size by 15%.|||units on a scale||Standard Deviation|Mean
2699436|NCT01249833|Other Pre-specified|Change in Mood Assessment|"Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales).~The range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm.~Each scale was anchored such that the lower the value, the better the mood."|Change from baseline at Day 4|All randomised subjects with data collected at both Baseline and Day 4. Baseline data was available for all randomized subjects in both groups; Day 4 data was available for 54 of 59 randomized subjects in the Oseltamivir Group (54 analysed) and for 58 of 63 randomized subjects in the Standard of Care Alone Group (58 analysed).|||millimeter||Standard Error|Least Squares Mean
2699437|NCT01249833|Secondary|Change in Processing Speed Assessment|"Processing speed assessed with the animal number decoding subtest~The lower the value, the better the processing speed"|Change from baseline at Day 4|All randomized subjects for whom data was collected at both Baseline and Day 4. Oseltamivr Group: Baseline data available for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline data available for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed).|||Millliseconds||Standard Error|Least Squares Mean
2699438|NCT01249833|Secondary|Change in Working Memory Assessment|"Working memory assessed with the Dot Memory Test.~The higher the value, the better the working memory."|Change from baseline at Day 4|All randomised subjects with data collected at both Baseline and Day 4. Oseltamivir Group: Baseline values collected for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline values collected for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed)|||Number of correct answers||Standard Error|Least Squares Mean
2699439|NCT01249833|Primary|Change in Attention Assessment|"Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:~Reaction Time Subtest~Cued Reaction Time Subtest~The lower the value, the better the attention."|Change from baseline at Day 4|All randomised subjects for whom data was collected at both baseline and Day 4. Oseltamivir group: baseline data available for 58 of 59 randomised subjects and Day 4 data for 53 subjects (53 subjects analysed). Standard of Care Alone group: baseline data available for 61 of 63 subjects and Day 4 data for 55 subjects (55 subjects analysed).|||milliseconds||Standard Error|Least Squares Mean
2699440|NCT01249664|Secondary|Mean Change in Area of Leakage From Baseline at Week 24 - LOCF|A negative change from baseline indicates improvement, ie, less leakage.|Baseline, Week 24||||Disc areas||Standard Deviation|Mean
2699441|NCT01249664|Secondary|Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks||Baseline, Week 24||||Percentage of participants|||Number
2699442|NCT01249664|Secondary|Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline, Week 24||||Scores on a scale||Standard Deviation|Mean
2699443|NCT01249664|Secondary|Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline, Week 24||||Scores on a scale||Standard Deviation|Mean
2699444|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 48||||Disc areas||Standard Deviation|Mean
2699445|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 24||||Disc areas||Standard Deviation|Mean
2699446|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 48||||microns||Standard Deviation|Mean
2699447|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 24||||microns||Standard Deviation|Mean
2699448|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
2699449|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
2699450|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
2699451|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
2699452|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
2699453|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
2699469|NCT01249625|Secondary|Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Confirmed Respiratory Illnesses|Number of lab confirmed respiratory illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.|60 weeks||||number of respiratory illnesses|||Number
2699454|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
2699455|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
2699456|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
2699457|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
2699458|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
2699459|NCT01249664|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases|Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24||||Letters correctly read||Standard Deviation|Mean
2699460|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
2699461|NCT01249664|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24||||Letters correctly read||Standard Deviation|Mean
2699462|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline to 8 weeks|Full analysis set (96 participants)|||Participants|||Number
2699463|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.|||Participants|||Number
2699464|NCT01249651|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn.|||Number of days||Standard Deviation|Mean
2699465|NCT01249651|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline to 8 weeks|Full analysis set (96 participants)|||Number of days||Standard Deviation|Mean
2699466|NCT01249625|Secondary|Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Laboratory Confirmed Illness|Number of laboratory confirmed influenza illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.|60 weeks||||Number of laboratory confirmed illnesses|||Number
2699467|NCT01249625|Secondary|Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Acute Respiratory Illnesses|Number of acute respiratory illnesses in healthcare practitioners wearing N95 respirators compared to medical masks.|60 weeks||||number of acute respiratory illnesses|||Number
2699472|NCT01249417|Secondary|Goal Attainment Scale (GAS) Score|GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699473|NCT01249417|Secondary|Physician's Global Assessment (PGA) of the Treatment Response.|"PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: how would you rate the response to treatment in the subject's lower limb(s) since the last injection? Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved)."|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699474|NCT01249417|Primary|Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb|The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Change from baseline to Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699475|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12|The intensity of lower limb pain was evaluated using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: 'no pain' (circle with no red shading and scored as 0) and 'pain as bad as it could be' (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699476|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)|Range of active dorsiflexion of the ankle joint, both with the knee flexed (90°) and extended (measured by goniometry) was used to assess treatment response. The measurements were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||Degrees||95% Confidence Interval|Least Squares Mean
2699477|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)|The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699478|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)|The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||Degrees||95% Confidence Interval|Least Squares Mean
2717847|NCT01116882|Primary|30-day Composite Major Adverse Cardiac Event (MACE)||30 days|The denominator for MACE at 30 days is defined as patients who either had MACE to 30d or had follow up of at least 23 days.|||participants|||Number
2699479|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)|The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699480|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)|The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||Degrees||95% Confidence Interval|Least Squares Mean
2699481|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
2699482|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
2699483|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
2699484|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
2699485|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
2699486|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
2699487|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
2699488|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
2699489|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
2699490|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
2699491|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
2699492|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1 and 12 are reported.|Baseline and Weeks 1 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
2699493|NCT01249404|Other Pre-specified|PGA of Treatment Response at Week 12|An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores at Week 12 are reported.|At Week 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 12 are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699514|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population|Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699494|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12|Muscle tone in the treated limb was assessed by MAS in the soleus (with the knee flexed) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699495|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1 and 12 are reported.|Baseline and Weeks 1 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699496|NCT01249404|Secondary|Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.|Baseline and Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at baseline and Week 4 are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
2699497|NCT01249404|Secondary|Physician's Global Assesment (PGA) of Treatment Response at Week 4|An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.|At Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 4 are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699498|NCT01249404|Primary|Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.|Baseline and Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
2699499|NCT01249365|Primary|Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies|Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.|Throughout the study (from Month 0 to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2699515|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699516|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population|Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2720332|NCT01096875|Secondary|Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively||Change between statin and placebo groups at 30 days postoperatively||||percentage of LVEF||Standard Deviation|Mean
2699500|NCT01249365|Primary|Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)|"Medically significant conditions (MSCs) are defined as:~AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.~Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.~Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination."|Throughout the study (from Month 0 to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.|||Participants|||Count of Participants
2699501|NCT01249365|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|Throughout the study (from Month 0 to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.|||Participants|||Count of Participants
2699502|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 3 months post 12-week trial period|intent-to-treat|||participants who relapsed to cocaine use|||Number
2699503|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 12 weeks|intent-to-treat|||participants who relapsed to cocaine use|||Number
2699504|NCT01249274|Secondary|Salivary Progesterone Concentrations|A comparison of salivary progesterone concentrations across all samples for all timepoints|week 2, week 6, week 10, week 12|intent-to-treat|||pg/ml of salivary progesterone||Standard Error|Mean
2699505|NCT01249274|Secondary|Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))|EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.|baseline to 12 weeks|intent-to-treat|||units on a scale||Standard Error|Mean
2699506|NCT01249274|Secondary|Cocaine Craving (Measured Weekly Using CCQ-Brief)|CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.|baseline to 12 weeks|intent-to-treat|||units on a scale||95% Confidence Interval|Mean
2699507|NCT01249274|Secondary|Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group|To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.|12 weeks postpartum|intent-to-treat|||adverse events|||Number
2699508|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|baseline, end of trial (week 12) and 3-month post-trial follow-up|intent-to-treat|||proportion of positive urines per week||95% Confidence Interval|Mean
2699509|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|weekly measurements, baseline to 12 weeks|intent-to-treat|||proportion of positive urines per week||95% Confidence Interval|Mean
2699510|NCT01249274|Primary|Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar|baseline, end of trial (week 12), 3-month post-trial follow-up|intent-to-treat|||days of cocaine use between visits||95% Confidence Interval|Mean
2699511|NCT01249274|Primary|Mean Number of Days Per Week of Cocaine Use|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.|Weekly measurements, Baseline to 12 weeks|intent-to-treat|||number of days per week of cocaine use||Standard Deviation|Mean
2699512|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699513|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population|Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699517|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population|Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699518|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699519|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699520|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699521|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699522|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699523|NCT01249261|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
2699524|NCT01249157|Primary|To Evaluate the Accuracy of Preoperative 18FDG PEM|using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.|2 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2699525|NCT01249131|Primary|Apparent Volume of Distribution (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2699526|NCT01249131|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2699527|NCT01249131|Primary|Minimum Observed Plasma Concentration (Cmin)||Day 1 at 0 hour (predose)|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2699528|NCT01249131|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2699529|NCT01249131|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2699530|NCT01249118|Primary|Percent of GDC-0973 Excreted in the Urine (% Excreted) for IV and Oral GDC-0973|% Excreted is the mean percentage of dose recovery in urine and calculated as: (Aeu divided by dose) multiplied by 100, where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose|Full analysis population.|||Percent dose excreted||Geometric Coefficient of Variation|Geometric Mean
2699545|NCT01249118|Primary|Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2699531|NCT01249118|Primary|Renal Clearance (CLR) of IV and Oral GDC-0973|CLR was calculated as Aeu divided by AUC (0 - ∞), where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose and AUC(0 - ∞) was area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity hrs post-dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 for plasma; 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose for urine|Full analysis population.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2699532|NCT01249118|Primary|Amount of Drug Excreted in the Urine (Aeu) of IV and Oral GDC-0973|The cumulative amount of drug excreted in urine over the entire collection interval of 96 hrs was calculated by adding the Aeu of the intervals 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 hrs where Aeu was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose on Day 1|Full analysis population.|||mg||Geometric Coefficient of Variation|Geometric Mean
2699533|NCT01249118|Primary|Mean Absorption Time (MAT)|MAT is mean time required for the drug to reach the central compartment. MAT was estimated from the mean resident time (MRT) from oral and IV administration. MAT was calculated as MRT last of oral dose minus MRT last of IV dose. MAT is analyzed when drug is administered orally (only for non-IV routes of administration).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|"Full analysis population who received oral dose of GDC-0973. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||hr||Geometric Coefficient of Variation|Geometric Mean
2699534|NCT01249118|Primary|Absolute Oral Bioavailability (F) of GDC-0973|Absolute oral bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. F = [AUC (0-∞), oral multiplied by Dose IV] divided by [AUC (0-∞), IV multiplied by Dose oral]. Absolute oral bioavailability is determined for drugs which are administered orally. IV dose is 100% in systemic circulation (dosed directly) and hence no estimation is required.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2699535|NCT01249118|Primary|Apparent Volume of Distribution (Vz/F) of Oral GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2699536|NCT01249118|Primary|Volume of Distribution at Steady State (Vss) of IV GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose of Day 1|Full analysis population who received IV dose of GDC-0973.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2699537|NCT01249118|Primary|Apparent Oral Clearance (CL/F) of Oral GDC-0973|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modelling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2699538|NCT01249118|Primary|Systemic Clearance (CL) of IV GDC-0973|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received IV dose of GDC-0973.|||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2699539|NCT01249118|Primary|Plasma Decay Half-Life (t1/2) of IV and Oral GDC-0973|t1/2 is the time measured for the plasma concentration of GDC-0973 to decrease by one half.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||hr||Geometric Coefficient of Variation|Geometric Mean
2699540|NCT01249118|Primary|Dose Normalized AUC (0 - ∞) [AUC (0 - ∞)dn] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞)dn is AUC(0 - ∞) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2699541|NCT01249118|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2699542|NCT01249118|Primary|Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2699543|NCT01249118|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2699544|NCT01249118|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||hr||Full Range|Median
2720333|NCT01096875|Primary|Endothelial Progenitor Cells (EPCs) Count (Cells/µl)||Postoperative 6th hours||||cells/µl||Standard Error|Mean
2699547|NCT01249118|Primary|Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973||Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population included participants who were randomized, received study drug, and had at least 1 valid PK parameter.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2699548|NCT01249092|Secondary|Safety of Therapy in the Pilot Study of PTX Therapy in Patients With PBC Will be Assessed|The number of participants that experienced any severe adverse events will be monitored and recorded.|6 months||||participants|||Number
2699549|NCT01249092|Secondary|Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy.|Serum concentration of tissue inhibitor metalloproteinase 1 (TIMP-1), a fibrosis biomarker of interest, will be measured and the change in serum levels between entry and end of study will be calculated.|6 months|Serum samples from both timepoints (entry and end of study) were available in only 16 of the 18 subjects who completed the study.|||ng/mL||Standard Error|Mean
2699550|NCT01249092|Primary|Change in Serum Alkaline Phosphatase Levels.|Serum alkaline phosphatase levels at entry and at 6 months of therapy with PTX will be measured and compared.|6 months||||U/L||Standard Deviation|Mean
2699551|NCT01249027|Secondary|Number of Participants With All Target Vessel Revascularization|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699552|NCT01249027|Secondary|Number of Participants With All Target Vessel Revascularization|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699553|NCT01249027|Secondary|Number of Participants With All Target Vessel Revascularization|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699554|NCT01249027|Secondary|Number of Participants With All Target Vessel Revascularization|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699555|NCT01249027|Secondary|Number of Participants With All Target Vessel Revascularization|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699556|NCT01249027|Secondary|Number of Participants With All Target Lesion Revascularization|Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699557|NCT01249027|Secondary|Number of Participants With All Target Lesion Revascularization|Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699558|NCT01249027|Secondary|Number of Participants With All Target Lesions Revascularization|Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699559|NCT01249027|Secondary|Number of Participants With All Target Lesion Revascularization|Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699560|NCT01249027|Secondary|Number of Participants With All Target Lesions Revascularization|Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699561|NCT01249027|Secondary|Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)|Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.|5 years|Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.|||Participants|||Count of Participants
2699562|NCT01249027|Secondary|Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)|Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.|4 years|Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.|||Participants|||Count of Participants
2699563|NCT01249027|Secondary|Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)|Dual Anti-platelet Therapy (DAPT) is Aspirin & Clopidogrel/Ticlopidine/Other.|3 years|Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.|||Participants|||Count of Participants
2699564|NCT01249027|Secondary|Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)|Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.|2 years|Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.|||Participants|||Count of Participants
2699565|NCT01249027|Secondary|Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)|Dual Anti-platelet Therapy (DAPT) is Aspirin and Clopidogrel/Ticlopidine/Other.|1 year|Analysis population for each visit is the number of patients completed each protocol-required follow-up. Visit window± 42days.|||Participants|||Count of Participants
2699566|NCT01249027|Secondary|Number of Participants With Major Bleeding Complications (According to GUSTO Classification)|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events:~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 1867 days|Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.|||Participants|||Count of Participants
2699567|NCT01249027|Secondary|Number of Participants With Major Bleeding Complications (According to GUSTO Classification)|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events:~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 1502 days|Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.|||Participants|||Count of Participants
2699568|NCT01249027|Secondary|Number of Participants With Major Bleeding Complications (According to GUSTO Classification)|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events:~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 1137 days|Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.|||Participants|||Count of Participants
2699569|NCT01249027|Secondary|Number of Participants With Major Bleeding Complications (According to GUSTO Classification)|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events:~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 772 days|Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.|||Participants|||Count of Participants
2699570|NCT01249027|Secondary|Number of Participants With Major Bleeding Complications (According to GUSTO Classification)|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events:~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention.~Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise.~Mild: Bleeding that does not meet criteria for either moderate or severe bleeding."|0 to 407 days|Major Bleeding Complication analysed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any major bleeding complication event.|||Participants|||Count of Participants
2699579|NCT01249027|Secondary|Number of Participants With Any MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699571|NCT01249027|Secondary|Number of Participants With Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699572|NCT01249027|Secondary|Number of Participants With Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699573|NCT01249027|Secondary|Number of Participants With Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699574|NCT01249027|Secondary|Number of Participants With Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699575|NCT01249027|Secondary|Number of Participants With Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699576|NCT01249027|Secondary|Number of Participants With Any MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699577|NCT01249027|Secondary|Number of Participants With Any MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699578|NCT01249027|Secondary|Number of Participants With Any MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699758|NCT01247363|Secondary|Area Under the Concentration Time Curve (AUC)|AUC for Day 1 is AUC from 0 to 24 hours. AUC for all other days is AUC at a dosing interval.|Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours Postdose|Participants who were administered study drug.|||nanogram.hour/milliliter (ng.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2699580|NCT01249027|Secondary|Number of Participants With Any MI|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699581|NCT01249027|Secondary|Number of Participants Experiencing Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~- Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699582|NCT01249027|Secondary|Number of Participants Experiencing Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~- Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699583|NCT01249027|Secondary|Number of Participants Experiencing Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~- Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699584|NCT01249027|Secondary|Number of Participants Experiencing Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~- Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699585|NCT01249027|Secondary|Number of Participants Experiencing Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~- Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699586|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death and Any MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699587|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death and Any MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699588|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death and Any MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699589|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death and Any MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699590|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death and Any MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699591|NCT01249027|Secondary|Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))|"Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699592|NCT01249027|Secondary|Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))|"Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699593|NCT01249027|Secondary|Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))|"Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699594|NCT01249027|Secondary|Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))|"Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699595|NCT01249027|Secondary|Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))|"Ischemia-Driven Target Vessel Failure (TVF) is the composite endpoint comprised of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target lesion revascularization by Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699596|NCT01249027|Secondary|Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699597|NCT01249027|Secondary|Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699598|NCT01249027|Secondary|Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699599|NCT01249027|Secondary|Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699600|NCT01249027|Secondary|Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699601|NCT01249027|Secondary|Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)|"Cardiac Death:Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699602|NCT01249027|Secondary|Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)|"Cardiac Death:Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699603|NCT01249027|Secondary|Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)|"Cardiac Death:Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699604|NCT01249027|Secondary|Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)|"Cardiac Death:Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699605|NCT01249027|Secondary|Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)|"Cardiac Death:Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699606|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699607|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699608|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699609|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699610|NCT01249027|Secondary|Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699799|NCT01247220|Secondary|Retinal Thickness|central foveal thickness on optical coherence tomography|6 and 12 months||||microns||Standard Deviation|Mean
2699611|NCT01249027|Secondary|Number of Participants With Stent Thrombosis|"Definite Stent Thrombosis (ST) occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Nonocclusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-followup, defined as subjects who are lost to followup through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699612|NCT01249027|Primary|Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1867 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699613|NCT01249027|Primary|Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1502 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699614|NCT01249027|Primary|Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1137 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699615|NCT01249027|Primary|Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 772 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699616|NCT01249027|Primary|Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 407 days|Analysis Population exclude subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given time point without any DMR event (all death, all MI, all revascularization) or stent thrombosis event.|||Participants|||Count of Participants
2699658|NCT01248884|Secondary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2699617|NCT01248962|Secondary|The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate|Perform exploratory analyses to correlate hypersensitivity rate to history of atopy, prior drug allergies, number of lifetime platinum cycles, duration since last platinum, and concomitant chemotherapy agent.|2 years|Among the evaluable 114 participants, 15 experienced a Hypersensitivity Reaction/HSR. 6 of the 56 participants in the extended-infusion group and 9 of the 58 participants in the standard-infusion group. These participants were analyzed as a group as the relationship of baseline variables to the rate of carboplatin HSRs were analyzed.|||Odds Ratio||95% Confidence Interval|Number
2699618|NCT01248962|Secondary|Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.||2 years|Data were not collected||||||
2699619|NCT01248962|Secondary|The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group||2 years||||Participants|||Count of Participants
2699620|NCT01248962|Primary|Number of Participants With and Without Hypersensitivity Reaction|The primary objective of this study is to determine if patients have lower rates of hypersensitivity reactions by comparing the number of participants with and without hypersensitivity reaction|2 years||||Participants|||Count of Participants
2699621|NCT01248949|Primary|Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline|KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.|From start of study drug administration up to 30 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617|||Participants|||Number
2699622|NCT01248949|Secondary|Circulating Levels of Angiopoietin 2 (Ang2)|Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations.|Prior to infusion on Cycle 4 and Cycle 5|All participants who received treatment with MEDI3617 and for whom PD blood samples were collected and evaluated.|||nanogram per millileter (ng/mL)||Standard Deviation|Mean
2699623|NCT01248949|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until death due to any cause|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
2699624|NCT01248949|Secondary|Progression-Free Survival (PFS)|PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
2699625|NCT01248949|Secondary|Time to Progression (TTP)|Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
2699626|NCT01248949|Secondary|Duration of Response (DOR)|Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
2699627|NCT01248949|Secondary|Time to Response (TTR)|"Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be 0 if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method."|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
2699628|NCT01248949|Secondary|Objective Response Rate (ORR)|"Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be 0 if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
2699629|NCT01248949|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.|Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617|All participants who received treatment with MEDI3617.|||participants|||Number
2699630|NCT01248949|Secondary|Terminal Elimination Half Life (t1/2) of MEDI3617|"The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||day||Standard Deviation|Mean
2699631|NCT01248949|Secondary|Systemic Clearance (CL) of MEDI3617|"Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||milliliter per day (mL/day)||Standard Deviation|Mean
2699632|NCT01248949|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617|"The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||day*mcg/mL||Standard Deviation|Mean
2699633|NCT01248949|Secondary|Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617|"AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||day*mcg/mL||Standard Deviation|Mean
2699634|NCT01248949|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI3617|"Cmax is the maximum observed serum concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
2699635|NCT01248949|Primary|Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617|||Participants|||Number
2699636|NCT01248949|Primary|Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
2699637|NCT01248949|Primary|Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)|Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
2699638|NCT01248949|Primary|Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)|Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
2699671|NCT01248780|Secondary|American College of Rheumatology 20 Response, Using CRP, at Week 24|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Number of participants|||Number
2699754|NCT01247428|Primary|Angiographic In-Stent Late Lumen Loss|In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.|8 months|Last observation used, such that patients (n=10) in the 8 month analysis is reported.|||mm||Standard Deviation|Mean
2699639|NCT01248949|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
2699640|NCT01248949|Primary|Maximum Tolerated Dose (MTD)|The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.|From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)|DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.|||milligram (mg)|||Number
2699641|NCT01248949|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.|From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)|DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.|||Participants|||Number
2699642|NCT01248936|Primary|Number of Participants With Any Serious Adverse Event, Death and Cause of Death|Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.|||participants|||Number
2699643|NCT01248936|Primary|Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.|||participants|||Number
2699644|NCT01248936|Secondary|Mean Time to Complete Response/Partial Response|Mean time to Complete Response (CR)/Partial Response(PR) (confirmed or unconfirmed was assessed). Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Months||Standard Deviation|Mean
2699645|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was confirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants were assessed for best overall response by investigator as per RECIST v1.1. The 'n' is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Participants|||Number
2699646|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed)|The best overall response (confirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was confirmed. Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Participants|||Number
2699659|NCT01248884|Primary|Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2699647|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. This endpoint was tumor response category according to investigator assessment per RECIST v1.1 for efficacy assessment. The 'n' is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated patients who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Participants|||Number
2699648|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed)|The best overall response (unconfirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed. Participants were assessed for best overall response by investigator as per 'Response Evaluation Criteria in Solid Tumors' (RECIST v1.1).|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||participants|||Number
2699649|NCT01248884|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
2699650|NCT01248884|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
2699651|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
2699652|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
2699653|NCT01248884|Secondary|Number of Subjects With a Vaccine Response to PT and PRN.|Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699654|NCT01248884|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||µg /mL||95% Confidence Interval|Geometric Mean
2699655|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699656|NCT01248884|Secondary|Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2699657|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699660|NCT01248884|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699661|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699662|NCT01248884|Primary|Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2699663|NCT01248884|Primary|Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2699664|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699665|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
2699666|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14|BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Score on a scale||Standard Deviation|Mean
2699667|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14|BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Score on a scale||Standard Deviation|Mean
2699668|NCT01248793|Secondary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 24|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Participants|||Number
2699669|NCT01248793|Primary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Participants|||Number
2699670|NCT01248780|Secondary|HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline|The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ.|Baseline to Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Scores on a scale||Standard Deviation|Mean
2699672|NCT01248780|Secondary|Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of Good or Moderate at Week 14. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A Moderate response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14."|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Number of participants|||Number
2699673|NCT01248780|Primary|American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Number of participants|||Number
2699674|NCT01248728|Secondary|Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language|"The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language.~Secondary outcome measure domain: Total language standard score~Total Language Standard Score Range:~Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities)~The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score.~Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
2699675|NCT01248728|Secondary|Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite|"The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning~Adaptive Behaviour Composite Standard Score Range:~Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning)~The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score.~Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
2699676|NCT01248728|Secondary|Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)|"The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention.~Change is rated as:~0- Not assessed~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse~Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7."|24 weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||participants classified as responders|||Number
2699677|NCT01248728|Primary|Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite|"The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours.~Primary Outcome domain: Externalizing Problems composite~Externalizing Problems Composite T-Score Range:~Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems)~The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score.~Mean change between baseline and week 24 is reported. A negative change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
2699678|NCT01248728|Primary|Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score|"The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity.~PDDBI Autism Composite Scale Range:~Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity)~The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score.~Mean change between baseline and week 24 is reported. A negative change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
2699679|NCT01248715|Secondary|Number of Participants With Hospital Mortality.|Number of subjects who died while hospitalized|through study completion, up to 30 days||||Participants|||Count of Participants
2699680|NCT01248715|Secondary|Length of Hospital Stay|Duration of hospitalization calculated as the day of discharge minus the day of admission.|through study completion, up to 30 days||||days||Inter-Quartile Range|Median
2699681|NCT01248715|Secondary|Days to Reach Clinical Stability|Time to clinical improvement. The criteria for clinical improvement were followed during the first week from the day of admission and defined as follows: a) improvement of signs and symptoms of LRTI reported by patient b) afebrile for at least 8 hours, c) decrease in white blood cell count to more than 10% from the prior day, and d) able to tolerate oral feeding. A patient was considered clinically improved on the day that these four criteria were all met.|30 days||||days||Inter-Quartile Range|Median
2699682|NCT01248715|Primary|Number of Participants That Had Short-term Mortality|Number of subjects who died within 30 days of enrollment|30 days||||Participants|||Count of Participants
2699683|NCT01248715|Primary|Number of Participants That Required Re-hospitalization|Participants that were re-hospitalized within 30 days after enrollment.|30 days||||Participants|||Count of Participants
2699685|NCT01248715|Primary|Number of Participants With Clinical Failure (Failure to Reach Clinical Stability)|Number of subject that showed lack of clinical improvement within 7 days. Criteria for clinical improvement include no fever; white blood cell count decreases, or increases in the case of leukopenia, to more than 10% from the prior day; the evaluation of signs and symptoms of CAP to define when the patient is subjectively better, and the patient is able to tolerate food by mouth.|7 days||||Participants|||Count of Participants
2699686|NCT01248468|Secondary|Percent of Subjects Who Are Free of Photophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours||||Percent of participants|||Number
2699687|NCT01248468|Secondary|Percent of Subjects Who Are Free of Phonophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.|||Percent of participants|||Number
2699688|NCT01248468|Secondary|Percent of Subjects Who Are Free of Nausea at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.|||percent of participants|||Number
2699689|NCT01248468|Primary|Percent of Subjects Who Are Pain Free at 2 Hours.|Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.|||Percent of participants|||Number
2699690|NCT01248455|Secondary|Count of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 3 years and 5 months||||Participants|||Count of Participants
2699691|NCT01248455|Primary|Response Rate|Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR >25% and <50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium >2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin <10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.|1 year|Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).|||percentage of participants|||Number
2699692|NCT01248416|Secondary|Change in Estrone||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 1 Subject, did not have Estrone results available for the 24 month visit (N=64).|||pg/mL||Standard Error|Mean
2699693|NCT01248416|Secondary|Change in Estradiol|Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole.|0 to 24 months|Of the 51 AI alone or AI/GH combined Subjects, 41 completed all procedures at 24 months, however, 1 Subject did not have Estrone results available for the 24 month visit (N=40).|||pg/mL||Standard Error|Mean
2699694|NCT01248416|Secondary|Change in Testosterone||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months.|||ng/dL||Standard Error|Mean
2699695|NCT01248416|Secondary|Change in IGF-I Concentrations||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 1 Subject, did not have IGF-1 results available for the 24 month visit (N=64).|||ng/mL||Standard Error|Mean
2699696|NCT01248416|Secondary|Change in Body Mass Index||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months.|||kg/m^2||Standard Error|Mean
2699697|NCT01248416|Secondary|Change in Lean Body Mass||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 2 Subjects had a screw/pin in their leg/hip at the 24 month visit, and therefore, could not have a DEXA scan performed (N=63).|||kg||Standard Error|Mean
2699698|NCT01248416|Secondary|Change in Bone Density z Score Adjusted for Height||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 2 Subjects had a screw/pin in their leg/hip at the 24 month visit, and therefore, could not have a DEXA scan performed (N=63).|||z-score||Standard Error|Least Squares Mean
2699699|NCT01248416|Primary|Change in Predicted Height|Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)|0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months.|||centimeters||Standard Error|Least Squares Mean
2699700|NCT01248416|Primary|Change in Height|Differences in height gains|0 to 24 months|Differences in height gains from 0 to 24 months; Of the 76 Subjects, 65 completed all procedures at 24 months.|||Centimeters||Standard Error|Mean
2699701|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||g||Standard Error|Least Squares Mean
2699702|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1|Treated set (OR)|||g||Standard Error|Least Squares Mean
2699703|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28|"Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||g||Standard Error|Least Squares Mean
2699704|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||g/dL/h||Standard Error|Least Squares Mean
2699705|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)|||g/dL/h||Standard Error|Least Squares Mean
2699706|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1|Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)|||g||Standard Error|Least Squares Mean
2699707|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28|"Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|Baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||umol/kgFFM/min||Standard Error|Least Squares Mean
2699708|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1|Change from baseline in rate of endogenous glucose production (EGP) fast after one dose|Baseline and day 1|Treated set (OR)|||umol/kgFFM/min||Standard Error|Least Squares Mean
2699709|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 28|"Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable"|Baseline and day 28|Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit|||mmol/L||Standard Error|Least Squares Mean
2699710|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 1|Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1|Baseline and day 1|Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))|||mmol/L||Standard Error|Least Squares Mean
2699711|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|A multiple linear regression model approach was used to estimate gastric emptying based on the breath test samples at each time point. Gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal||||proportion of tracer||Standard Deviation|Mean
2699712|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy|The scintigraphic gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal||||proportion of tracer||Standard Deviation|Mean
2699713|NCT01248221|Primary|Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.|4 hours after ingestion of standard meal||||minutes||Standard Deviation|Mean
2699714|NCT01248221|Primary|Gastric Emptying Half Time Measured by Scintigraphy|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.|4 hours after ingestion of standard meal||||minutes||Standard Deviation|Mean
2699715|NCT01248130|Primary|Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores|The CGI-PDD is a well-established, 3-item, clinician-rated measure of global symptom severity and treatment response, specifically for PDD. This scale allows the clinician to rate the severity of the participant's PDD relative to baseline.|weekly|||||||
2699716|NCT01248130|Primary|Change in Social Responsiveness Scale (SRS) Total Raw Score|Change in SRS Total Raw Score|pre-treatment, 6 weeks, post-treatment (12 weeks)|||||||
2699719|NCT01248065|Primary|Treatment Failure|Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.|Twenty-eight week intervention period from randomization until end of trial.||||Percentage of participants||95% Confidence Interval|Number
2699720|NCT01248013|Primary|Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.|The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater.|One year after termination of treatment||||percentage of participants|||Number
2699721|NCT01248013|Secondary|Outcome Predictors|to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result|one year|||||||
2699722|NCT01248013|Primary|Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome|assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months|one year|||||||
2699723|NCT01247974|Primary|Primary Effectiveness Endpoint|Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.|7 days postoperatively or hospital discharge, whichever is sooner|Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial.|||percentage of participants|||Number
2699724|NCT01247974|Primary|Primary Safety Endpoint|"A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:~Death~Myocardial Infarction (MI)~Stroke~Mediastinal Reoperation~Percutaneous Coronary Intervention (PCI)"|30 days postprocedure|Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment.|||percentage of participants|||Number
2699725|NCT01247922|Secondary|Median Treatment Duration||From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)|SAF|||days||Full Range|Median
2699726|NCT01247922|Secondary|Best Overall Response|Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.|End of treatment (The mean treatment duration was 170.5 days.)|SAF|||participants|||Number
2699727|NCT01247922|Primary|Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)|Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.|From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)|The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug.|||participants|||Number
2699728|NCT01247675|Secondary|Emax of IGF-I|"As part of the following endpoint:~Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group.~Emax (maximum observed response) values at Week 4"|Days 22 to 29|Pharmacokinetic and pharmacodynamic analysis was performed on all patients who had at least one measurement of the primary variable and who had attended the Day 28 study visit. Two patients in Cohort 2 (ACP-001, 0.04 mg hGH/kg/wk) were withdrawn from the study before Day 28 and were therefore excluded from the analysis.|||ng/mL||Standard Deviation|Mean
2699729|NCT01247675|Secondary|Cmax of hGH|"As part of the following endpoint:~Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group.~Cmax (maximum value of concentration) values at Week 4"|Days 22 to 29|Pharmacokinetic and pharmacodynamic analysis was performed on all patients who had at least one measurement of the primary variable and who had attended the Day 28 study visit. Two patients in Cohort 2 (ACP-001, 0.04 mg hGH/kg/wk) were withdrawn from the study before Day 28 and were therefore excluded from the analysis.|||ng/mL||Standard Deviation|Mean
2699730|NCT01247675|Primary|Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation|Number of subjects with treatment emergent anti-hGH binding antibodies|Start of study treatment through Day 42|All patients who were randomized and received at least one dose of test product were included in the Safety analysis.|||Participants|||Number
2699731|NCT01247675|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.|Start of study treatment through Week 4|All patients who were randomized and received at least one dose of test product were included in the Safety analysis.|||Number of subjects with any symptom|||Number
2699735|NCT01247571|Primary|Percentage of Participants With Progression-free Survival (PFS) at 6 Months|Progression-free survival is the period from study entry until disease progression, death or date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2699736|NCT01247571|Primary|Objective Tumor Response (Complete or Partial)|Complete and Partial Tumor Response by RECIST 1.0. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2699737|NCT01247428|Secondary|OCT Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|18 M|27 out of 30 patients analyzed|||percentage of struts uncovered||Full Range|Median
2699738|NCT01247428|Secondary|Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 9/30 patients had evaluable OCT at the 8 month timeframe.|||percentage of struts uncovered||Full Range|Median
2699739|NCT01247428|Secondary|IVUS Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|18 months|20 out of 30 participants analyzed|||percentage of volume obstruction||Standard Deviation|Mean
2699740|NCT01247428|Secondary|Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 25/30 patients had evaluable IVUS data.|||percentage of volume obstruction||Standard Deviation|Mean
2699741|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|18 months|Population includes participants from whom data was collected.|||participants|||Number
2699742|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|4 months, 6 months, 8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months.|||participants|||Number
2699743|NCT01247428|Secondary|Stent Thrombosis|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|240 days||||percentage of participants||95% Confidence Interval|Number
2699744|NCT01247428|Secondary|Target Lesion Failure (TLF)|"Target lesion failure (TLF) is defined as the composite endpoint of:~cardiac death,~target-lesion myocardial infarction (Q wave or non-Q wave), and~clinically indicated target lesion revascularization"|240 days||||percentage of participants||95% Confidence Interval|Number
2699745|NCT01247428|Secondary|Target Vessel Failure (TVF)|"Target vessel failure (TVF) is defined as the composite endpoint of:~cardiac death,~target-vessel myocardial infarction (Q wave or non-Q wave), and~clinically indicated target vessel revascularization"|240 days||||percentage of participants||95% Confidence Interval|Number
2699746|NCT01247428|Secondary|Clinically-driven Target Vessel Revascularization (TVR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:~A positive history of recurrent angina pectoris, presumably related to the target vessel;~Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;~Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);~A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days||||percentage of participants||95% Confidence Interval|Number
2699747|NCT01247428|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:~A positive history of recurrent angina pectoris, presumably related to the target vessel;~Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;~Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);~A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days||||percentage of participants||95% Confidence Interval|Number
2699748|NCT01247428|Secondary|Total Myocardial Infarction (MI)|"Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.~Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves."|240 days||||percentage of participants||95% Confidence Interval|Number
2699749|NCT01247428|Secondary|Total Mortality|Total mortality (cardiac and non-cardiac)|240 days||||percentage of participants||95% Confidence Interval|Number
2699750|NCT01247428|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge|8 hours||||percentage of participants||95% Confidence Interval|Number
2699751|NCT01247428|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method|8 hours||||percentage of participants||95% Confidence Interval|Number
2699759|NCT01247363|Primary|Number of Participants With Clinically Significant Adverse Effects|Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product.|Day 1 through Day 49|Participants who were administered study drug.|||Participants|||Count of Participants
2699760|NCT01247350|Secondary|Pharmacokinetics: Renal Excretion of LY3009104|Percentage of LY3009104 excreted in urine from zero to 24 hours.|Day 1: continuous for 24 hours|Participants who were administered study drug (10 mg and 14 mg LY3009104 per protocol) and had pharmacokinetics (PK) samples for the analyses.|||percentage of drug||Geometric Coefficient of Variation|Geometric Mean
2699761|NCT01247350|Secondary|Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)|Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||hour (h)||Full Range|Median
2699762|NCT01247350|Secondary|Pharmacokinetics: Apparent Total Body Clearance of LY3009104|Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2699763|NCT01247350|Secondary|Pharmacokinetics: Apparent Volume of Distribution of LY3009104|Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2699764|NCT01247350|Secondary|Pharmacokinetics: Half-Life(t1/2) of LY3009104|Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||hour (h)||Full Range|Geometric Mean
2699765|NCT01247350|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104|AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2699766|NCT01247350|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104|Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2699767|NCT01247350|Primary|Number of Participants With Clinically Significant Effects|Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.|Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses|Participants who were administered study drug.|||Participants|||Count of Participants
2699768|NCT01247324|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab|Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.|Baseline up to week 96|Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.|||Participants|||Number
2699769|NCT01247324|Secondary|Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)|AUC represents total drug exposure for one dosing interval after the 4th dose.|Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96|The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.|||micrograms per milliliter*day||Standard Deviation|Mean
2699770|NCT01247324|Secondary|Number of Participants With Adverse Events (AEs)|AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.|Baseline up to Week 96|The safety population included all participants who received any study drug.|||Participants|||Number
2699771|NCT01247324|Secondary|Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96|NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2699800|NCT01247220|Secondary|Number of Ranibizumab Injections|Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period|12 months||||injections||Full Range|Mean
2699801|NCT01247220|Primary|Visual Acuity|ETDRS visual acuity|6 and 12 months||||letters on ETDRS Visual Acuity Chart||Standard Deviation|Mean
2699772|NCT01247324|Secondary|Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline, Week 96|Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||t-score||Standard Error|Mean
2699773|NCT01247324|Secondary|Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96|"Brain volume was recorded as an absolute normalized value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week."|From Week 24 up to Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percent change||Standard Error|Mean
2699774|NCT01247324|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96|MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.|Baseline, Week 96|ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||Z-score||Standard Error|Mean
2699775|NCT01247324|Secondary|Number of T1 Hypointense Lesions During the Double-Blind Treatment|The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.|||lesions|||Number
2699776|NCT01247324|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 108|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
2699777|NCT01247324|Secondary|Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks|Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2699778|NCT01247324|Secondary|Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment|The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.|||lesions|||Number
2699779|NCT01247324|Secondary|Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment|The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.|||lesions|||Number
2699802|NCT01247090|Primary|Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period|This is designed to measure if the administration of intradialytic AVP will result in change in systolic blood pressure.|Baseline and Two Weeks||||mm Hg||Standard Deviation|Mean
2699803|NCT01247064|Secondary|Parental Perception of Improvement of Breathing After Study Medication||1 hour||||percentage of participants|||Number
2699804|NCT01247064|Secondary|Oxygen Saturation Change||Baseline and 1 hour||||percent||95% Confidence Interval|Mean
2699805|NCT01247064|Secondary|Respiratory Rate Change||Baseline and 1 hour||||breaths per minute||95% Confidence Interval|Mean
2699780|NCT01247324|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 108|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
2699781|NCT01247324|Primary|Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks|ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.|Week 96|Intent-to-treat (ITT) population included all randomized participants in the study.|||relapses/participant year of treatment||95% Confidence Interval|Number
2699782|NCT01247298|Secondary|Percentage of Participants With Local Failure Patterns|Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred|Baseline up to 2 years after treatment completed||||percentage of participants|||Number
2699783|NCT01247298|Secondary|Percentage of Participants With Overall Survival|Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.|up to 2 years after treatment completed|Survival analysis was performed for all patients.|||percentage of participants|||Number
2699784|NCT01247298|Primary|Local Recurrence Rate|Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.|Baseline to up to 2 years after treatment completed||||participants|||Number
2699785|NCT01247298|Primary|Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.|Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.|Baseline to up to 2 years after treatment completed||||months||95% Confidence Interval|Median
2699786|NCT01247298|Primary|Safety of a Combination Therapy|Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.|Baseline to 45 day after completing combination treatment.|All enrolled patients were analyzed.|||participants|||Number
2699787|NCT01247285|Secondary|AUC0-inf of Norfluoxetine.|Informational comparison of AUC0-inf values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699788|NCT01247285|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699789|NCT01247285|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2699790|NCT01247285|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699791|NCT01247285|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699792|NCT01247285|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2699793|NCT01247272|Secondary|AUC0-inf of Norfluoxetine.|Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699794|NCT01247272|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699795|NCT01247272|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2699796|NCT01247272|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699797|NCT01247272|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2699798|NCT01247272|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2699807|NCT01247064|Primary|Respiratory Assessment Change Score (RACS)|The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.|Baseline and 1 hour||||units on a scale||95% Confidence Interval|Mean
2699808|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Mean
2699809|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Mean
2699810|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Mean
2699811|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Log Mean
2699812|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Log Mean
2699813|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Log Mean
2699814|NCT01246999|Primary|Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR|Nasal washes were collected on days 2, 4 and 7 after vaccination. Nasal swab specimens were tested for the presence of vaccine viruses by quantitative viral culture in MDCK cells at 33º C and by real-time quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) amplification. The limit of detection of vaccine viruses was 10^0.6 tissue culture infectious doses (50%)/ml for virus culture and 10^0.4 tissue culture infectious doses (50%)/ml for qRT-PCR.|baseline to day 7|Outcome for shedding of live vaccine in all participants who received a live vaccine|||participants|||Number
2699815|NCT01246973|Secondary|Percentage of Subjects With Moist Desquamation|Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.|6 weeks||||percentage of participants|||Number
2699816|NCT01246973|Primary|Mean Radiation Dermatitis Severity Score|The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
2699817|NCT01246960|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion (up to Month 28.3)|Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo).|||participants|||Number
2699818|NCT01246960|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Months 1, 2, 4, 6, and 8|Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies.|||participants|||Number
2699819|NCT01246960|Secondary|Time to Disease Progression (TTP)|TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.|Randomization to measured PD (up to Month 25.0)|ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||Full Range|Median
2699820|NCT01246960|Secondary|Duration of Response|Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time of first response to measured PD (up to Month 23.0)|Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||95% Confidence Interval|Median
2699821|NCT01246960|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)*100.|Randomization to measured PD (up to Month 23.0)|ITT population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2699822|NCT01246960|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.|Randomization to date of death from any cause (up to Month 28.3)|ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||95% Confidence Interval|Median
2699823|NCT01246960|Primary|Progression-Free Survival (PFS)|PFS was defined using Response Evaluation Criteria in Solid Tumors [RECIST version (v.) 1.1] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.|Randomization to measured PD or date of death from any cause (up to Month 25.0)|ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||95% Confidence Interval|Median
2699824|NCT01246895|Other Pre-specified|Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.|SF-36 v2 includes 2 aggregate measures—Physical and Mental components—derived from 8 subscales. Least squares means are adjusted for baseline. Higher positive scores indicate better results. Scoring ranges from 0 to 100%.|1 and 5 years||||Percent change from baseline||Standard Deviation|Least Squares Mean
2699825|NCT01246895|Secondary|The Number of Participants With Adverse Events Until 5 Years|Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.|5 years|Participants who experienced adverse events|||participants|||Number
2699826|NCT01246895|Secondary|Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)|The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. A higher score indicates a better health state improvement.|5 years|1 datapoint not made available from 1 patient out of 34 patients in the Experimental group|||Percentage change||Standard Deviation|Least Squares Mean
2699827|NCT01246895|Primary|Repair Tissue Quality (T2 MRI)|Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.|5 years|5 aberrant imaging datapoint from 5 patients out of 34 patients were removed from the Experimental group and 4 aberrant imaging datapoint from 4 patients out of 34 patients were removed from the Control group|||T2 relaxation time (ms)||Standard Deviation|Least Squares Mean
2699828|NCT01246895|Primary|Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.|Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).|5 years|33 out of 34 BST-CarGel with percentage lesion filled measurement. 1 aberrant imaging datapoint from 1 patient out of 34 patients was removed from the Experimental group|||Percentage of lesion filled (%)||Standard Deviation|Least Squares Mean
2699829|NCT01246791|Primary|Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hr^-1||Standard Deviation|Mean
2699830|NCT01246791|Primary|Elimination Rate Constant (Kel) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hr^-1||Standard Deviation|Mean
2699831|NCT01246791|Primary|Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
2699832|NCT01246791|Primary|Mean Residence Time (MRT) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
2699833|NCT01246791|Primary|Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
2699834|NCT01246791|Primary|Plasma Half Life (t1/2) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
2699835|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
2699836|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
2699837|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||pg/mL||Standard Deviation|Mean
2699838|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||ng/mL||Standard Deviation|Mean
2699839|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||pg･hr/mL||Standard Deviation|Mean
2699840|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||ng･hr/mL||Standard Deviation|Mean
2699841|NCT01246713|Primary|Acetaminophen Metabolites|Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.|8 hours||||mcg.hr/ml||Standard Error|Mean
2699842|NCT01246479|Secondary|Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322).|Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322).|Months 12, 24 and 36|Safety Population|||Participants|||Count of Participants
2699843|NCT01246479|Secondary|Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)|Months 12, 24 and 36|Safety Population|||Participants|||Count of Participants
2699844|NCT01246479|Secondary|Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)|Month 24, 36|Intent to Treat Population|||percentage of participants|||Number
2699845|NCT01246479|Secondary|GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)|Month 12, 24 and 36|Intent to Treat Population|||Titer||95% Confidence Interval|Geometric Mean
2699846|NCT01246479|Primary|Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12|intention to treat population; assessment of seroprotection ~1 year post primary vaccination series in parent study IC51-322|||percentage of participants||95% Confidence Interval|Number
2699847|NCT01246401|Secondary|ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX|The arm/group number of the participants vary from the primary outcome because this is a treatment effect analysis. All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.|6 months|All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.|||Participants|||Count of Participants
2699848|NCT01246401|Secondary|Opioid Abstinence at 6 Months for Those With More Than 4 Injections|Based on self reported opioids (heroin) use. All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections were compared to those who receive 4 or more XR-NTX injection.|6 months|Collected via Time Line Fall Back (TLFB). Total N analyzed is 74. 12 of the clients had initial or some TLFB data indicating relapse but were counted as lost at 6 months for outcome 4. 19 Clients did not have TLFB data or if they did within 6 month it did not indicate any relapse. These were treated as missing and not included in analysis.|||Participants|||Count of Participants
2699849|NCT01246401|Secondary|Participants With Opiate Abstinence Via By Doing Urine Toxicology Test|Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive).|6 month||||Participants|||Count of Participants
2699850|NCT01246401|Secondary|Antiretroviral Therapy (ART) Adherence 100%|Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100%|6 months|56 participants with missing data were considered as failure - meaning - with adherence less than 100%, and included into the analysis.|||Participants|||Count of Participants
2699851|NCT01246401|Secondary|Craving for Opioids|Craving at baseline compared to 6 month. This is assessed through a self report scale rated 0 to 10; 0 meaning not craving and 10 meaning highest craving. Change in craving score was categorized as 1)no change between baseline and 6 month; 2)increased craving - baseline craving was reported lower than at 6 month; 3)decreased craving - baseline craving was reported higher than 6 month craving.|6 months|Data available at 6 month determined who was included into the analysis. In this case a total of 47 data points (those with both baseline and 6 month data points) were included into the analysis (32 Extended-Release Naltrexone and 15 Placebo).|||Participants|||Count of Participants
2699852|NCT01246401|Secondary|Addiction Severity|"The Addiction Severity Index (ASI) questionnaire will be used to assess addiction severity. The ASI composite scoreprovides reliable and valid measure of patient status in a particular module of interest which can then be usecompared at the beginning of treatment to the evaluation endpoint to note the improvement or lack thereof. In this assessment the drug composite score was calculated using algorithm by Treatment Research Institute. If the score increases then it shows increase in severity where as if it decreases then it shows decrease in severity for that measured module. The scale ranges from 0 to 1.~The mean composite scores for drug use from baseline to 6 months were compared using Nonparametric test."|baseline, and 6 months|An additional subject's data from the experimental group was not collected at baseline. For the 6 months data, the total number of participants with completed assessment used for the analysis was 46 (31 in XR-NTX group and 15 in Placebo group).|||units on a scale||Standard Deviation|Mean
2699853|NCT01246401|Secondary|Time to Opioid Relapse or End of Intervention|Measuring days to first relapse based on self reported opioids (heroin) use within the 6 month (180 days) intervention period. If participants had no follow-up visits, and thus no self reported opiate use, they were treated as missing. Those who did not relapse within the 6 month intervention period were treated as having 180 days until relapse.|6 months|Data collected via Time Line Fall Back (TLFB). 15 in XR-NTX group and 4 in Placebo did not have data because of attrition - treated as missing. An additional 19 people in the treatment arm and 9 in placebo filled out the TLFB at 9 or 12 months, and this data was used to fill in missing information.|||days||Full Range|Median
2699854|NCT01246401|Secondary|CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additional labs will be drawn every 3 months for 1 year to monitor changes in CD4 levels.|Baseline and 6 months|Data was collected via labs. At month 6, due to attrition, data was only available for a total of 46 subjects. These include, 14 in Placebo and 32 in Extended-Release Naltrexone. The mean and STD are presented below.|||cells/ml||Standard Deviation|Mean
2699855|NCT01246401|Secondary|Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.|6 months|A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.|||Participants|||Count of Participants
2699856|NCT01246401|Primary|Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.|6 months|A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.|||Participants|||Count of Participants
2699857|NCT01246349|Primary|Child Dietary Self-Efficacy Scale|"A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods.~The questionnaire is made up of 20 likert items with 3 response options, including not sure, a little sure, and very sure. Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, How sure are you that you could eat cereal instead of a donut? Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy."|Baseline, 6 month follow-up||||scores on a scale||Standard Deviation|Mean
2699858|NCT01246349|Secondary|Psychological Well-being|Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)|Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment|||||||
2699859|NCT01246349|Secondary|Physiological Outcomes: Waist Circumference|Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.|Baseline, 6 month follow-up||||cm||Standard Deviation|Mean
2699860|NCT01246349|Secondary|Physiological Outcomes: BMI|The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.|Baseline, 6 month follow-up||||z-score||Standard Deviation|Mean
2699881|NCT01246063|Primary|Phase 2 - Toxicity of Carfilzomib in Combination With PLD and Dexamethasone as Measured by Number of Participants Who Experience Grade 3/4 Toxicity||Through 30 days after completion of treatment (median number of cycles was 9.5 (range 1-34))|For this outcome measure the Phase I - Part 2 participants were combined with the Phase 2 participants as they received the same dosing regimen. Phase I - Part 1 participants were not evaluable for this outcome measure.|||Participants|||Count of Participants
2701951|NCT01230424|Secondary|Change in Time to Complete 5 Chair Stands.|Change in time (seconds) to complete 5 chair stands. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||seconds||95% Confidence Interval|Mean
2699861|NCT01246349|Primary|Weight Efficacy Life-style Questionnaire|"A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight.~The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident).~The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses.~The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined."|Baseline, 6 month follow-up||||scores on a scale||Standard Deviation|Mean
2699862|NCT01246258|Other Pre-specified|Utricular Centrifugation Test (UCF)|balance assessment|one day||||participants|||Number
2699863|NCT01246258|Primary|Vestibular Evoked Myogenic Potentials (VEMPs)|These are the balance tests that specifically assess the otolith organ.|one day||||participants|||Number
2699864|NCT01246206|Secondary|"Determine Time to Engraftment (PLT20)"|"The number of days until engraftment (PLT20)"|Followed for up to two years post transplant|All paarticipants|||days||Full Range|Median
2699865|NCT01246206|Secondary|"Determine Time to Engraftment (G500)"|"The number of days until engraftment (G500)"|Followed for up to two years post transplant|All paarticipants|||days||Full Range|Median
2699866|NCT01246206|Secondary|Overall Survival at Two Year,||Followed for up to two years post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2699867|NCT01246206|Secondary|Estimate Incidence of Chronic GVHD at Two Years|Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks|Followed for up to two years post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2699868|NCT01246206|Secondary|Determine Incidence of Opportunistic Infections||Followed for up to two years post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2699869|NCT01246206|Primary|Severity of Acute GVHD|Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks|Assessed first 6 months post transplant|Those participants who contracted Acute GVHD|||% of participants with sever aGVHD||95% Confidence Interval|Number
2699870|NCT01246206|Primary|Safety Defined by Serious Adverse Events|Counted the number of participants that experienced any type of grade 3 or higher toxicity.|Assessed first 6 months post transplant||||participants|||Number
2699871|NCT01246206|Primary|Incidence of Acute GVHD|Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks|Assessed first 6 months post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2699872|NCT01246076|Secondary|Time to Progression|The time to progression is defined as the time from registration to the date of progression or last follow-up. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)|Time to progression was not analyzed. This was a prespecified secondary outcome but due to the early termination of the study time to progression was not followed.||||||
2699873|NCT01246076|Secondary|Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4||30 days after end of treatment (up to 60 weeks)||||participants|||Number
2699874|NCT01246076|Secondary|Time to Discontinuation of Treatment||Up to 56 weeks (14 cycles)|16 out of 24 participants were evaluable for this outcome measure as these 16 participants completed at least the first cycle of treatment.|||cycles||Full Range|Median
2699875|NCT01246076|Secondary|Duration of Response||Until 6 months after end of treatment|8 participants had a response -- all had MCR.|||days||Full Range|Median
2699876|NCT01246076|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who were alive 6 months after end of treatment.|6 months after end of treatment (up to 82 weeks from start of treatment)||||percentage of participants|||Number
2699877|NCT01246076|Primary|Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria|"Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts.~Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematological improvement they will be noted in addition to marrow CR).~Partial remission (PR): previously had ≥5% myeloblasts and now have ≥5% myeloblasts but decreased by ≥50% compared to pre-treatment, bone marrow morphology not relevant, ≥11 g/dl peripheral blood hemoglobin, ≥100x109cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood ANC, and 0% peripheral blood blasts"|Up to 56 weeks (14 cycles of treatment)|8 participants were not evaluable for this outcome measure because they did not complete at least one cycle of therapy.|||participants|||Number
2699878|NCT01246063|Secondary|Median Duration of Overall Response|"For participants with confirmed tumor responses~A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria"|Through completion of follow-up (median follow-up was 23.3 months)||||months||95% Confidence Interval|Median
2699879|NCT01246063|Secondary|Progression-free Survival Time (Phase 2 Only)|-Progression per IMWG Criteria|Through completion of follow-up (median follow-up was 23.3 months)|This outcome measure is for Phase 2 (including Phase I Part 2) participants only. Phase I Part 2 and Phase 2 participants who began alternative anti-multiple myeloma treatment prior to progression were censored.|||months||95% Confidence Interval|Median
2699880|NCT01246063|Secondary|Median Overall Survival||Completion of follow-up (median of 23.3 months)||||months||95% Confidence Interval|Median
2699895|NCT01245764|Primary|Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)||Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had temperature data|||Participants|||Number
2699882|NCT01246063|Primary|Phase 2 - Efficacy of Carfilzomib in Combination With PLD and Dexamethasone as Measured by the Percentage of Participants With Confirmed Tumor Responses|-A confirmed response is defined to be a complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG Criteria.|Completion of treatment (median number of cycles was 9.5 (range 1-34))|For this outcome measure the Phase I - Part 1 Dose Level 3 and Phase I - Part 2 participants were combined with the Phase 2 participants as they received the same dosing of carfilzomib. The remaining Phase I - Part 1 participants were not evaluable for this outcome measure.|||Participants|||Count of Participants
2699883|NCT01246063|Primary|Maximum Tolerated Dose (MTD) of Dexamethasone (Phase I - Part 2).|-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.|28 days (completion of first cycle of all Phase I - Part 2 patients)|Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.|||mg|||Number
2699884|NCT01246063|Primary|Maximum Tolerated Dose (MTD) of Carfilzomib and PLD (Phase I - Part 2).|-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.|28 days (completion of first cycle of all Phase I - Part 2 patients)|Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.|||mg/m^2|||Number
2699885|NCT01246063|Primary|Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).|"MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.~Please note that the maximum tolerated dose of carfilzomib and pegylated liposomal doxorubicin was not reached. The data below is the recommended dosage for further studies."|28 days (completion of first cycle of all Phase I - Part 1 patients)|Participants enrolled in the Phase I - Part 1 portion of this study were the only evaluable participants for this outcome measure.|||mg/m^2|||Number
2699886|NCT01246050|Primary|Number of Superior Heart Failure Performance Outcome Quality Measures|"This was a pilot, qualitative study to assess the feasibility and preliminary outcomes of a program to train primary care providers in specialty care.~9 Heart Failure Performance Outcome Quality Measures were studied:~Patient weight measured at clinic visit; level of activity assessed; volume status assessed; Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker (ACEI/ARB) prescribed; ACEI/ARB at target dose; beta-blocker prescribed; beta-blocker at target dose; evidence-based beta-blocker used; coumadin prescribed in atrial fibrillation.~Healthcare provider performance with each of the Performance Outcome Quality Measures was assessed at each study visit. Superior performance was defined as a higher score for each Measure on the follow-up visit compared to the baseline visit.~The primary outcome of the study was considered to have been reached if 6 of the 9 outcome measures were superior to the baseline visit."|12 months|129 patients cared for by HF trained primary care providers in Intervention Arm. 129 patients in the Control group, cared for by non-HF trained primary care providers.|||number of outcome measures superior|||Number
2699887|NCT01246011|Secondary|Major Bleeding Events.|Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.|At 2weeks post CABG|No analysis will be done due to early study termination.||||||
2699888|NCT01246011|Primary|Coronary Artery Bypass Vein Graft Patency|Vein graft patency as measured by computed tomography|Approximately 30 Days post CABG|No analysis will be done due to early study termination||||||
2699889|NCT01245972|Primary|Tumor Clearance|Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).|21 to 36 days after the treatment||||Participants|||Count of Participants
2699890|NCT01245764|Secondary|GMT of Anti-HPV Type 18 Antibody|Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2699891|NCT01245764|Secondary|GMT of Anti-HPV Type 16 Antibody|Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2699892|NCT01245764|Secondary|GMT of Anti-HPV Type 11 Antibody|Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2699893|NCT01245764|Secondary|Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody|Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2699894|NCT01245764|Primary|Number of Participants With Serious Adverse Experiences|A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention|From the time of informed consent is signed through the last study visit (up to 19 months)|The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up|||Participants|||Number
2699896|NCT01245764|Primary|Number of Participants With Injection-site Adverse Experiences|Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences|Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up|||Participants|||Number
2699897|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 18|Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of >=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
2699898|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 16|Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
2699899|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 11|Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of >=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
2699900|NCT01245764|Primary|Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6|Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
2699901|NCT01245751|Secondary|Number of Participants Reporting One or More Adverse Experiences|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.|Up to 42 days postvaccination|Analysis included all vaccinated participants who had any safety follow-up|||Participants|||Number
2699902|NCT01245751|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 only.|||Fold Rise||95% Confidence Interval|Geometric Mean
2699903|NCT01245751|Primary|Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.|||gpELISA Units/mL||95% Confidence Interval|Geometric Mean
2699904|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
2699905|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
2699906|NCT01245738|Primary|Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
2699927|NCT01245647|Secondary|Risky Sexual Behaviors|Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.|4 months||||percentage of persons with risky sex|||Number
2699907|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
2699908|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
2699909|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements at Week 12.|||Percentage of Participants|||Number
2699910|NCT01245738|Primary|Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins|TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had TG measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
2699911|NCT01245738|Primary|Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins|HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had HDL-C measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
2699912|NCT01245738|Primary|Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins|LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had LDL-C measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
2699913|NCT01245738|Primary|Change From Baseline in TC Levels After Treatment|TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the Full Analysis Set (FAS) Population who had a TC measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
2699914|NCT01245738|Primary|Triglycerides (TG) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a TG measurement at baseline.|||mg/dL||Standard Deviation|Mean
2699915|NCT01245738|Primary|High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a HDL-C measurement at baseline.|||mg/dL||Standard Deviation|Mean
2699916|NCT01245738|Primary|Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a LDL-C measurement at baseline.|||mg/dL||Standard Deviation|Mean
2699917|NCT01245738|Primary|Total Cholesterol (TC) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a total cholesterol measurement at baseline.|||mg/dL||Standard Deviation|Mean
2699918|NCT01245699|Primary|CPR Quality- Pre-shock Pause|Pre-shock pause: time from cessation of CPR to shock delivery|During CPR||||sec||95% Confidence Interval|Median
2699919|NCT01245699|Primary|CPR Quality-Chest Compression Rate|Mean Chest Compression Rate|During CPR||||CCs/min||95% Confidence Interval|Mean
2699920|NCT01245699|Primary|CPR Quality-compression Fraction|Chest Compression Fraction indicating the percentage of time in which chest compressions are done by rescuers during a cardiac arrest|During CPR||||% of time chest compressions are done||95% Confidence Interval|Median
2699921|NCT01245699|Primary|CPR Quality|Chest Compression Release Velocity|during CPR||||mm/s||95% Confidence Interval|Mean
2699922|NCT01245699|Primary|CPR Quality-percent of >51mm Compressions|Percent of Chest Compressions greater than 51mm|during CPR||||percentage of chest compressions >51mm||95% Confidence Interval|Median
2699923|NCT01245699|Primary|CPR Quality-compression Depth|Measurement of chest compression depth|during CPR||||mm||95% Confidence Interval|Mean
2699924|NCT01245673|Primary|Primary Myeloma Endpoint|To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant.|Between day 100 and 180 post transplant|Subjects that reached D100 and D180|||Participants|||Count of Participants
2699925|NCT01245647|Secondary|CD4 Count (Mean)|Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.|4 months||||CD4 count (cells/ml)||Standard Deviation|Mean
2699926|NCT01245647|Secondary|HIV Viral Load Suppressed|Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)|4 months||||percentage of persons with suppressed VL|||Number
2699928|NCT01245647|Secondary|HIV Medication Adherence (95% or Better)|Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.|Month 4|Only persons who reported current HIV medication use (n=13) were considered for this outcome, and we included data from the 12 persons who completed the 4-month assessment.|||percentage of participants|||Number
2699929|NCT01245647|Primary|Number of Drinks Per Week|Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.|Month 4|All participants who provided data at the 4-month follow-up were included (n=15), which is 79% of persons who were randomized.|||standard alcohol drinks per week||Standard Deviation|Mean
2699930|NCT01245595|Primary|Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria|Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.|5 days||||participants|||Number
2699931|NCT01245439|Secondary|Health Assessment Questionnaire Score (General Score)|The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||units on a scale||Standard Deviation|Mean
2699932|NCT01245439|Secondary|Participant's Assessment of Pain|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||mm||Standard Deviation|Mean
2699933|NCT01245439|Secondary|Participant's (PT) and Investigator's (IN) Assessment of Disease Activity|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||mm||Standard Deviation|Mean
2699934|NCT01245439|Secondary|Mean Number of Tender and Swollen Joints|Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||joints||Standard Deviation|Mean
2699935|NCT01245439|Secondary|Erythrocyte Sedimentation Rate|ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr).|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category|||mm/hr||Standard Deviation|Mean
2699936|NCT01245439|Secondary|C-Reactive Protein Levels|CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.|||mg/dL||Standard Deviation|Mean
2699937|NCT01245439|Secondary|Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. .|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.|||Percentage of participants|||Number
2699938|NCT01245439|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
2699954|NCT01245439|Secondary|Percentage of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population|||percentage of participants|||Number
2699955|NCT01245439|Secondary|Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population|||percentage of participants|||Number
2699939|NCT01245439|Secondary|Disease Activity Score as Measured By DAS28 at Each Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. n = participants who were evaluable for specified category|||units on a scale||Standard Deviation|Mean
2699940|NCT01245439|Secondary|Percentage of Participants Achieving Their First Remission Status By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Percentage of participants|||Number
2699941|NCT01245439|Secondary|Percentage of Participants Who Achieved Remission (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.|||percentage of participants|||Number
2699942|NCT01245439|Secondary|Number of Participants Who Achieved Remission (DAS28) By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category|||participants|||Number
2699943|NCT01245439|Secondary|Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome|||Percentage of participants|||Number
2699944|NCT01245439|Secondary|Percentage of Participants Who Achieved LDA By Visit|"TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.|||percentage of participants|||Number
2699945|NCT01245439|Secondary|Number of Participants Who Achieved LDA By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.|||participants|||Number
2699946|NCT01245439|Secondary|Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: < 3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.|||percentage of participants|||Number
2699947|NCT01245439|Secondary|Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (<) 2.6 represents clinical remission, a score of: <3.2 represents low disease activity (LDA), and a score of > 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Intent- to- Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category|||participants|||Number
2699948|NCT01245439|Secondary|Percentage of Participants With Elevations in Lipids According to ATP III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL , Total cholesterol >240 mg/dL, HDL >60 mg/dL and TG >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; n = number of participants analyzed at the specified visit for the given parameter.|||percentage of participants|||Number
2699949|NCT01245439|Secondary|Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL, Total cholesterol >240 mg/dL, High Density Lipoprotein (HDL) >60 mg/dL and Triglycerides (TG) >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; Number (n) equals (=) number of participants analyzed at the specified visit for the given parameter.|||participants|||Number
2699950|NCT01245439|Secondary|Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)|ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL.|Baseline to Week 24|Safety population|||cells/µL||Standard Deviation|Mean
2699951|NCT01245439|Secondary|Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol|Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL).|Baseline to Week 24|Safety population; number of participants analyzed signifies participants who were evaluable for this outcome.|||mg/dL||Standard Deviation|Mean
2699952|NCT01245439|Secondary|Change From Baseline to Highest Values for ALT and AST|Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme.|Baseline to Week 24|Safety population|||IU/L||Standard Deviation|Mean
2699953|NCT01245439|Secondary|Number of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population|||participants|||Number
2699956|NCT01245439|Secondary|Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population|||participants|||Number
2699958|NCT01245439|Primary|Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.|24 weeks|The safety population consisted of all participants included in the study who received at least one dose of study medication and who had at least one post-baseline assessment of safety (that is post-baseline laboratory data, vital signs or adverse events).|||percentage of participants|||Number
2699959|NCT01245413|Primary|Visual Inspection of Baseplate Loosening|The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm^2|1 hour|ITT|||cm^2||Standard Deviation|Mean
2699960|NCT01245387|Other Pre-specified|IOP Mean Difference (Within a Participant)|Average predose minus postdose mean difference in IOP within a participant|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.|||mmHg||Standard Deviation|Mean
2699961|NCT01245387|Other Pre-specified|Change in IOP Between Predose and Postdose Assessment|IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||mmHg||Standard Deviation|Mean
2699962|NCT01245387|Other Pre-specified|Intraocular Pressure (IOP)|IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||mmHg||Standard Deviation|Mean
2699963|NCT01245387|Other Pre-specified|Treatment Tolerability|Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.|Month 24 or early termination|Safety Set; N=number of participants with evaluable data.|||Participants|||Number
2699964|NCT01245387|Other Pre-specified|Number of Participants With Complications Associated With Injection|Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.|Baseline up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.|||Participants|||Number
2699965|NCT01245387|Other Pre-specified|Time to First Adverse Event (AE)|Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.|Baseline up to Month 24 or early termination|Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.|||Days||95% Confidence Interval|Median
2699966|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Last Visit|Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699967|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 54|Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 54|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699968|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 48|Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 48|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699969|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 42|Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 42|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699970|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 36|Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 36|FAS; N=number of participants with evaluable data.|||Participants|||Number
2720369|NCT01096784|Secondary|Time to Discharge From Neonatal Intensive Care (TDNIC)||Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS with number of participants evaluable for this outcome.|||Days||Full Range|Median
2699971|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 30|Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 30|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699972|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 24|Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 24|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699973|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 18|Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 18|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699974|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 12|Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 12|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699975|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 6|Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 6|FAS;N=number of participants with evaluable data.|||Participants|||Number
2699976|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Baseline|Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Baseline|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699977|NCT01245387|Primary|Central Retinal Thickness|Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||Micrometers (Mcm)||Standard Deviation|Mean
2699978|NCT01245387|Primary|Number of Participants With PED at Last Visit|PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699979|NCT01245387|Primary|Number of Participants With PED at Week 54|PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 54|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699980|NCT01245387|Primary|Number of Participants With PED at Week 48|PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 48|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699981|NCT01245387|Primary|Number of Participants With PED at Week 42|PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 42|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699982|NCT01245387|Primary|Number of Participants With PED at Week 36|PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 36|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699983|NCT01245387|Primary|Number of Participants With PED at Week 30|PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 30|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699984|NCT01245387|Primary|Number of Participants With PED at Week 24|PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 24|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699985|NCT01245387|Primary|Number of Participants With PED at Week 18|PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 18|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699986|NCT01245387|Primary|Number of Participants With PED at Week 12|PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 12|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699987|NCT01245387|Primary|Number of Participants With PED at Week 6|PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 6|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699988|NCT01245387|Primary|Number of Participants With Pigment Epithelial Detachment (PED) at Baseline|PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Baseline|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699989|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit|Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699990|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 72|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 72|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699991|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 66|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 66|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699992|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 60|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 60|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699993|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 54|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 54|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699994|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 48|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 48|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699995|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 42|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 42|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699996|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 36|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 36|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699997|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 30|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 30|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699998|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 24|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 24|FAS; N=number of participants with evaluable data.|||Participants|||Number
2699999|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 18|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 18|FAS; N=number of participants with evaluable data.|||Participants|||Number
2700000|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 12|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 12|FAS; N=number of participants with evaluable data.|||Participants|||Number
2700001|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 6|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 6|FAS; N=number of participants with evaluable data.|||Participants|||Number
2700002|NCT01245387|Primary|Lesion Size (Number of Optic Disc Areas)|Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||number of optic disc areas||Standard Deviation|Mean
2700003|NCT01245387|Primary|Number of Participants With Investigator Assessments of Efficacy|Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.|Month 24 or early termination|FAS; N = number of participants with evaluable data.|||Participants|||Number
2700004|NCT01245387|Primary|Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score|Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, every 6 months up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||Scores on a scale||Standard Deviation|Mean
2700005|NCT01245387|Primary|Visual Acuity (VA)|VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.|||lines of VA||Standard Deviation|Mean
2700006|NCT01245374|Secondary|Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial||Weeks 0 - 6|The safety set consisted of all participants included in the trial and having taken at least one dose of trial treatment. The adverse events and technical complaints were collected during the treatment period (6 weeks after inclusion).|||participants|||Number
2700007|NCT01245374|Secondary|Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment|The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For two patients, no data available.|||percentage of participants|||Number
2700008|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
2700009|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
2700010|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
2700011|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Time Learning|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.|||percentage of participants|||Number
2700012|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Ease of Training|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
2700013|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.|||percentage of participants|||Number
2700014|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.|||percentage of participants|||Number
2700029|NCT01245283|Secondary|Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months|Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.|Baseline, 4 Months||||Seconds||Standard Deviation|Mean
2700015|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.|||percentage of participants|||Number
2700016|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|"Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.~For one patient, no data available."|||percentage of participants|||Number
2700017|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
2700018|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.|||percentage of participants|||Number
2700019|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For seven patients, no data available.|||percentage of participants|||Number
2700020|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
2700021|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Per protocol set (PP): All subjects in the ITT set using NordiFlex® and had completed the trial without any significant violation of the inclusion/exclusion criteria or any other aspect of the protocol considered to potentially affect the efficacy results.|||units on a scale||Standard Deviation|Mean
2700022|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||units on a scale||Standard Deviation|Mean
2700023|NCT01245283|Secondary|Seated Row Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
2700024|NCT01245283|Secondary|Shoulder Press Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
2700025|NCT01245283|Secondary|Chest Press; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
2700026|NCT01245283|Secondary|Leg Curl Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
2700027|NCT01245283|Secondary|Leg Extensions Test; Change From Baseline at 4 Months|Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
2700028|NCT01245283|Secondary|Leg Press Test; Change From Baseline at 4 Months|Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
2700030|NCT01245283|Secondary|Six Minute Walk Test; Change From Baseline at 4 Months|Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.|Baseline, 4 Months||||feet||Standard Deviation|Mean
2700031|NCT01245283|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months|"The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.~Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible).~0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)"|Baseline, 4 Months||||units on a scale||Standard Deviation|Mean
2700032|NCT01245270|Secondary|Bioavailability in Urine|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Urine will also be collected (if possible) 0, 1, 3 and 5 hours, with all urine collected within the 24 hour time period post intervention||2019-09-30|09/2019||||
2700033|NCT01245270|Secondary|Bioavailability in Plasma|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Plasma will also be collected -15,-10, -5, 15, 30, 45, 60, 90, 120, 150, and 300 minutes and 24 hours post intervention||2019-09-30|09/2019||||
2700034|NCT01245270|Primary|Plasma Insulin iAUC (Incremental Area Under the Curve; ng/ml*Min)|"Volunteers were fasted (10-12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61•9%; polysaccharide, 49•2~%; sugars, 12•2%; glucose, 0•6%; maltose, 11•6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.~For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after the capsule||||insulin iAUC (ng/ml*min)||Standard Error|Mean
2700035|NCT01245270|Primary|Plasma Glucose iAUC (Incremental Area Under the Curve; mM*Min)|"Volunteers were fasted (10-12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61·9%; polysaccharide, 49·2~%; sugars, 12·2%; glucose, 0·6%; maltose, 11·6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.~For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post capsule||||glucose iAUC (mM*min)||Standard Error|Mean
2700036|NCT01245140|Secondary|Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|Serum pregnancy tests were performed at each visit for females of childbearing potential.|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); safety follow-up (Week 29)|Safety population. Only female participants were analysed for serum pregnancy test.|||Participants|||Number
2700037|NCT01245140|Secondary|Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal|A physical examination for each participant was performed at Baseline and at EOT (Week 24). The primary investigator classified physical status as either normal or abnormal.|Baseline and EOT (Week 24)|Safety Population|||Participants|||Number
2700038|NCT01245140|Secondary|Change From Baseline in Weight at EOT (Week 24)|Change from Baseline is defined as the value at EOT minus the value at Baseline.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.|||kg||Standard Deviation|Mean
2700039|NCT01245140|Secondary|Change From Baseline in Heart Rate at EOT (Week 24)|HR is defined as the rate at which the heart beats. Change from Baseline is defined as the value at EOT minus the Baseline value.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
2700040|NCT01245140|Secondary|Change From Baseline in SBP and DBP at EOT (Week 24)|Change from Baseline is defined as the value at EOT minus the Baseline value.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2700041|NCT01245140|Secondary|Mean Body Weight at Screening, Baseline ,and EOT (Week 24)|Body weight was measured at Screening, Baseline, and EOT.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Kilograms (kg)||Standard Deviation|Mean
2700042|NCT01245140|Secondary|Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24)|HR is defined as the rate at which the heart beats.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Beats per minute (bpm)||Standard Deviation|Mean
2700043|NCT01245140|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24)|SBP and DBP were assessed at Screening, Baseline, and EOT.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2725215|NCT01059682|Secondary|Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography||Throughout Study, 24 months||||Percent Diameter Stenosis||Standard Deviation|Mean
2700044|NCT01245140|Secondary|Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24); and safety follow-up (Week 29). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700045|NCT01245140|Secondary|Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Screening; Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24);and safety follow-up (Week 29).|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24), and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700046|NCT01245140|Secondary|Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of >=20 were re-evaluated within 2 weeks. If a CES-D score of >=20 was confirmed on the second occasion, and if the score represents an increase over BL of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. Change from BL is defined as the post-BL value minus the BL value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700047|NCT01245140|Secondary|Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of 20 or higher were re-evaluated within 2 weeks. If a CES-D score of 20 or higher was confirmed on the second occasion, and if the score represents an increase over Baseline of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation.|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700048|NCT01245140|Secondary|Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24)|Laboratory parameters included triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, LDL/HDL ratio, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and amylase and lipase. The central laboratory classified a finding as either abnormal or normal.|From Baseline until EOT (Week 24)|Safety Population|||Participants|||Number
2700049|NCT01245140|Secondary|Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)|Change from Baseline is defined as the value at the safety follow up visit minus baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24) and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Ratio||Standard Deviation|Mean
2700050|NCT01245140|Secondary|Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)|Fasted lipid laboratory parameters included triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2700051|NCT01245140|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment|An AE was any adverse change from the participant's Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect.|From Baseline until safety follow up (Week 29)|Safety Population: all randomized participants who received at least one dose of study medication|||Participants|||Number
2700052|NCT01245140|Secondary|Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24)|The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline, Week 12, and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700053|NCT01245140|Secondary|Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24)|The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24).|Baseline, Week 12, and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700054|NCT01245140|Secondary|Number of Participants With mPASI 50 Response and mPASI 75 Response|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline.|From Baseline until EOT (Week 24)|Full analysis set. Participants with lesions in areas of the body other than the hands and feet were assessed.|||Participants|||Number
2700055|NCT01245140|Secondary|Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value.|Baseline and EOT (Week 24) or the last assessment|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2700056|NCT01245140|Secondary|Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
2700057|NCT01245140|Secondary|Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24)|The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Pustule count||Standard Deviation|Mean
2700058|NCT01245140|Secondary|Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24)|The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Pustule count||Standard Deviation|Mean
2700304|NCT01243424|Secondary|Change From Baseline to Final Visit in Creatinine|Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates, participants on treatment|||mg/dL||Standard Error|Least Squares Mean
2700059|NCT01245140|Primary|Number of Participants With PPPASI 50 Response and PPPASI 75 Response|The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.|From Baseline until EOT (Week 24) or the last assessment|Full Analysis Set|||Participants|||Number
2700060|NCT01245140|Primary|Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment|The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.|Baseline and EOT (Week 24) or the last assessment|Full Analysis Set : treated participants with >=1 efficacy result after receiving study medication.|||Scores on a scale||Standard Deviation|Mean
2700061|NCT01245101|Secondary|Markers of Immune Activation|Flow cytometry will be performed in whole blood for analysis of markers of immune activation by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD8+CD38+ cells will be determined as the main outcome measure.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.|||Percentage of activated CD8+CD38+ cells||Standard Deviation|Mean
2700062|NCT01245101|Primary|Episomal HIV cDNA Formation|These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.|||copies/million||Standard Deviation|Mean
2700063|NCT01245062|Secondary|PFS Following Cross-over to Trametinib as Assessed by the Investigator|PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)|Cross-over Population|||Months||95% Confidence Interval|Median
2700064|NCT01245062|Secondary|DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator|DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)|Cross-over Population|||Months||95% Confidence Interval|Median
2700065|NCT01245062|Secondary|DoR for All Confirmed Responders (CR or PR) as Assessed by the Independent Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INDA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
2700066|NCT01245062|Secondary|DoR for All Confirmed Responders (CR or PR) as Assessed by the Investigator Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INVA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
2700703|NCT01240785|Secondary|Apgar Score at 5 Min After Delivery Per Arm|Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome|5 minutes after delivery||||units on a scale||Standard Deviation|Mean
2700067|NCT01245062|Secondary|DoR for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Independent Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the independently-assessed (INDA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
2700068|NCT01245062|Secondary|Duration of Response (DoR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Investigator Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the investigator-assessed (INVA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
2700069|NCT01245062|Secondary|Number of Participants With OR Following Cross-over to Trametinib|OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1. Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)|Cross-over Population|||Participants|||Number
2700070|NCT01245062|Secondary|Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Participants|||Number
2700071|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Participants|||Number
2700072|NCT01245062|Secondary|Number of Participants With OR as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Participants|||Number
2700073|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Participants|||Number
2700074|NCT01245062|Secondary|Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases|Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.|Day 1 until death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
2700075|NCT01245062|Secondary|Overall Survival in All Participants|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Day 1 until death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
2700076|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
2700077|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
2700078|NCT01245062|Secondary|Progression-free Survival in All Participants|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
2700079|NCT01245062|Primary|Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
2700080|NCT01245049|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 to Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.|||Participants|||Count of Participants
2700081|NCT01245049|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.|||Participants|||Count of Participants
2700082|NCT01245049|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.|||Participants|||Count of Participants
2700083|NCT01245049|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.|||Participants|||Count of Participants
2700084|NCT01245049|Secondary|Number of Seroconverted Subjects for Anti-mumps|Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)].|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700085|NCT01245049|Secondary|Number of Seroconverted Subjects for Anti-measles|Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)].|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700086|NCT01245049|Secondary|Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens|Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700704|NCT01240785|Secondary|Neonatal Hyperbilirubinemia Per Arm||0-3 days after delivery||||participants|||Number
2700705|NCT01240785|Secondary|Neonatal Hypoglycemia Per Arm||0-24 h after delivery||||participants|||Number
2700087|NCT01245049|Secondary|Number of Subjects With a Booster Response to PT, FHA and PRN Antigens|Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700088|NCT01245049|Secondary|Anti-Polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 0, before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2700089|NCT01245049|Secondary|Anti-rubella Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2700090|NCT01245049|Secondary|Anti-measles Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2700091|NCT01245049|Secondary|Anti-mumps Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||U/mL||95% Confidence Interval|Geometric Mean
2700092|NCT01245049|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|At Month 0, before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2700093|NCT01245049|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2700094|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-rubella Antibody|A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700095|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-mumps Antibody|A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700096|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-measles Antibody|A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700097|NCT01245049|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700098|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700099|NCT01245049|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700100|NCT01245049|Primary|Anti-Polio Virus Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2700305|NCT01243424|Secondary|Change From Baseline to Final Visit in Triglycerides|Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates, participants on treatment|||mg/dL||Standard Error|Least Squares Mean
2700101|NCT01245049|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2700102|NCT01245049|Primary|Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens|Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 0.4 IU/ml]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.|At Month 1, one month after the booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2700103|NCT01244984|Secondary|Number of Rescue Medication Inhalations|Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening).|Baseline up to Week 52|ITT Population. The number of participants analyzed depends on the number of participants remaining in the indaicated time period.|||Number of inhalations||Standard Deviation|Mean
2700104|NCT01244984|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population|||Percentage of rescue free 24-hour period||Standard Deviation|Mean
2700105|NCT01244984|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment|Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population|||Percentage of symptom-free days||Standard Deviation|Mean
2700106|NCT01244984|Secondary|Change From Baseline in Asthma Symptom Score During the Study Treatment|The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping.|Baseline up to Week 52|ITT Population|||Scores on a scale||Standard Deviation|Mean
2700107|NCT01244984|Secondary|Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment|Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated.|Baseline up to Week 52|ITT Population|||Litres per Minute (L/min)||Standard Deviation|Mean
2700108|NCT01244984|Secondary|Number of Participants With Severe Asthma Exacerbation During the Study Treatment|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|Baseline up to Week 52|ITT Population|||Participants|||Number
2700109|NCT01244984|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS.|Week 12, Week 24, and Week 52/WD|"ITT Population. . Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2700110|NCT01244984|Secondary|Change From Baseline in Heart Rate (HR)|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Beats/Minute||Standard Deviation|Mean
2700111|NCT01244984|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2700706|NCT01240785|Secondary|Shoulder Dystocia Per Arm||delivery||||participants|||Number
2700707|NCT01240785|Secondary|Induction of Delivery Per Arm||delivery||||participants|||Number
2700112|NCT01244984|Secondary|Change From Baseline in the 24-hour Urinary Cortisol Excretion|Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline (Week 0), Week 24, and Week 52/WD|Urine cortisol (UC) Population: all participants in the ITT Population from whom urine specimens were collected and who were considered not to have any confounding factors that might affect the analysis of the results of the specimens. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
2700113|NCT01244984|Secondary|Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2700114|NCT01244984|Secondary|Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||ratio of urine density to water density||Standard Deviation|Mean
2700115|NCT01244984|Secondary|Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||pH||Standard Deviation|Mean
2700116|NCT01244984|Secondary|Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2700117|NCT01244984|Secondary|Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Micromoles per Liter (µmol/L)||Standard Deviation|Mean
2700118|NCT01244984|Secondary|Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||International unit per liter (IU/L)||Standard Deviation|Mean
2700119|NCT01244984|Secondary|Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||g/L||Standard Deviation|Mean
2700120|NCT01244984|Secondary|Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||10^12 per liter (Ti/L)||Standard Deviation|Mean
2700319|NCT01243411|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2700121|NCT01244984|Secondary|Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Proportions of I||Standard Deviation|Mean
2700122|NCT01244984|Secondary|Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Grams per liter (g/L)||Standard Deviation|Mean
2700123|NCT01244984|Secondary|Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||10^9 per liter (Gi/L)||Standard Deviation|Mean
2700124|NCT01244984|Secondary|Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Percentage||Standard Deviation|Mean
2700125|NCT01244984|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period|||Participants|||Number
2700126|NCT01244906|Secondary|Number of Patients With Overall Survival at 2 Years.||2 years||||participants|||Number
2700127|NCT01244906|Secondary|Number of Patients to Achieve Full Donor Chimerism|Characterize rate of achievement of full donor chimerism|1 year||||participants|||Number
2700128|NCT01244906|Secondary|Number of Patients With Disease Free Survival at 2 Years||2 years||||participants|||Number
2700129|NCT01244906|Secondary|Number of Participants With Non-Relapse Mortality||1 year||||participants|||Number
2700130|NCT01244906|Secondary|Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment|To estimate the incidence of neutrophil and platelet engraftment|Approximately Day 30||||participants|||Number
2700131|NCT01244906|Primary|Incidence of GVHD|To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.|1 year||||participants|||Number
2700132|NCT01244893|Secondary|Bulbar Redness|Scale of 0 increasing to 4. 0=None, 4=Severe Redness|6-8 days after lens wear|Population analyzed consisted of those who were enrolled, randomized, and completed the study.|||units on a scale||Standard Deviation|Mean
2700133|NCT01244893|Secondary|Limbal Redness|Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.|||units on a scale||Standard Deviation|Mean
2700134|NCT01244893|Secondary|Corneal Staining|Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.|||units on a scale|eyes|Standard Deviation|Mean
2700135|NCT01244893|Primary|Visual Acuity (VA)|Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.|||logMAR scale||Standard Deviation|Mean
2700153|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700136|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Final Assessment|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.|Baseline up to Week 52|Participants who received at least one dose of study drug and had a baseline and at least one post-baseline PANSS measurement.|||score on a scale||Standard Error|Mean
2700137|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Week 52|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 PANSS measurement.|||score on a scale||Standard Error|Mean
2700138|NCT01244828|Primary|Change From Baseline in Prolactin at Week 52|Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||µg/L||Standard Deviation|Mean
2700139|NCT01244828|Primary|Change From Baseline in Insulin at Week 52|Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||µIU/mL||Standard Deviation|Mean
2700140|NCT01244828|Primary|Change From Baseline in Fasting Glucose at Week 52|Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||mmol/L||Standard Deviation|Mean
2700141|NCT01244828|Primary|Change From Baseline in HbA1c at Week 52|Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||percent||Standard Deviation|Mean
2700142|NCT01244828|Primary|Number of Participants With Extrapyramidal Symptoms|"This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for extrapyramidal syndrome were treated as extrapyramidal symptoms."|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|Participants who received at least one dose of study drug.|||participants|||Number
2700143|NCT01244828|Primary|Change From Baseline in BMI at Week 52|For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||kg/m^2||Standard Deviation|Mean
2700144|NCT01244828|Primary|Change From Baseline in Weight at Week 52|For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||kg||Standard Deviation|Mean
2700145|NCT01244815|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q overall score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700180|NCT01244529|Primary|Fit Acceptability|Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||percentage of eyes|eyes||Number
2700708|NCT01240785|Secondary|Gestational Weeks at Delivery Per Arm||delivery||||weeks||Standard Deviation|Mean
2700146|NCT01244815|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700147|NCT01244815|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 21|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 21; improvement in functioning is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of CGAS score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700148|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 21|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CDRS-R total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700149|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 14|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CDRS-R total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700150|NCT01244815|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score at Day 7|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CDRS-R total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700151|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700152|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700709|NCT01240785|Secondary|Mode of Delivery Per Arm||delivery||||no of cesarean section|||Number
2700154|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700155|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700156|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700157|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700158|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700159|NCT01244815|Secondary|Total Y-MRS 50% Responders at Days 4, 7, 14 and 21|A total Y-MRS 50% responder was defined as a participant who had a reduction from baseline to the identified study visit of at least 50% in the Y-MRS total score. The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items, based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60 with higher scores indicating greater severity of symptoms. This analysis used a Last-Observation-Carried-Forward (LOCF) approach; if at a given visit no Y-MRS total score was available for determining whether a participant was a responder, the last available post-baseline on-treatment assessment prior to that visit was used.|Baseline and Days 4, 7, 14 and 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included for a visit, a Y-MRS total score must be available for that visit or a prior post-baseline on-treatment visit|||participants|||Number
2700160|NCT01244815|Secondary|Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21|Change from baseline in CGI-BP overall score at Day 21 is the Key Secondary Outcome Measure. The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the participant's overall bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP overall score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700181|NCT01244529|Primary|Primary Gaze Lens Movement|Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||percentage of eyes|eyes||Number
2700710|NCT01240785|Secondary|Pre-eclampsia Per Arm||up to on the average 40 weeks of gestation||||participants|||Number
2700161|NCT01244815|Primary|Change From Baseline in Y-MRS Total Score at Day 21|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 21 value of Y-MRS total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2700162|NCT01244724|Secondary|National Hospital Seizure Severity Scale|Seizure severity score for each seizure type.|12 Weeks|Due to early termination of this study, data were not collected.||||||
2700163|NCT01244724|Primary|Hamilton Depression Scale|Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)|12 weeks||||units on a scale||Standard Deviation|Mean
2700164|NCT01244711|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).|12 weeks|Change in total score on the MADRS from baseline to final visit|||units on a scale|||Number
2700165|NCT01244633|Secondary|Columbia Scale for Suicide Risk|This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.|Every 7 days|||||||
2700166|NCT01244633|Secondary|Safety Assessments|Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.|Every 7 days|||||||
2700167|NCT01244633|Secondary|Clinician Global Impression - Improvement and Severity Scales (CGI)|This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.|End of trial|||||||
2700168|NCT01244633|Secondary|Premonitory Urge for Tics Scale (PUTS-1)|This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.|Every 7 days|||||||
2700169|NCT01244633|Secondary|Hamilton Depression Scale|This is a measure of feelings of depression that the patient might have.|Every 7 days|||||||
2700170|NCT01244633|Secondary|Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)|This is a standard measure of ADHD severity that is typically used in these types of clinical trials.|Every 7 days|||||||
2700171|NCT01244633|Primary|Yale Global Tic Severity Score|The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.|8 weeks|Subjects completing the study|||units on a scale||Standard Deviation|Mean
2700172|NCT01244620|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||Liter (L)||Standard Deviation|Geometric Mean
2700173|NCT01244620|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||hours||Standard Deviation|Mean
2700174|NCT01244620|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||mL/minute||Standard Deviation|Geometric Mean
2700175|NCT01244620|Primary|Area Under the Curve of the 24 Hour Dosing Interval (AUC24)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2700176|NCT01244620|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
2700177|NCT01244620|Primary|Trough Plasma Concentrations (Ctrough)|"Minimum or troughconcentrations"|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Geometric Mean
2700178|NCT01244620|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||hours||Full Range|Median
2700179|NCT01244529|Secondary|New Lens Power Fit Match to Control Lenses|The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||percentage of eyes|eyes||Number
2700711|NCT01240785|Secondary|Maternal Weight Gain Per Arm||up to on the average 40 weeks of gestation||||kg||Standard Deviation|Mean
2700182|NCT01244529|Primary|Lens Centration Acceptance|Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||eyes|eyes||Number
2700183|NCT01244516|Secondary|Overall Subjective Lens Handling|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.|||CLUE score||Standard Error|Least Squares Mean
2700184|NCT01244516|Primary|Corneal Staining|Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).|||percentage of eyes|Eyes||Number
2700185|NCT01244516|Primary|Overall Subjective Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).|||CLUE score||Standard Error|Least Squares Mean
2700186|NCT01244503|Secondary|Histology -NAS Scoring of Liver Biopsy|"OBT will be compared to histology (including NAS score as described above)and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.~NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system includes the following components: steatosis, which is scaled from 0-3, lobular inflammation, which is scaled from 0-3 and hepatocellular ballooning, which is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The range of the NAS score is from 0-8."|Up to 6 months||||units on a scale||Standard Deviation|Mean
2700187|NCT01244503|Primary|The Peak Value of the PDR (Percentage Dose Recovery of 13C) of OBT (Octanoate Breath Test)|To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD (non alcoholic fatty liver disease) compared to NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system, where steatosis is scaled from 0-3, lobular inflammation is scaled from 0-3 and hepatocellular ballooning is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The higher the PDR peak, the better the liver health and function.PDR units are percent per hour of 13C dose recovery and describes rate of metabolism. The PDR peak is the highest rate of metabolism the liver reaches.The total range of NAS is 0-8.|1 hour||||PDR peak value (%/hour)||Standard Deviation|Mean
2700188|NCT01244490|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|SP|||participants|||Number
2700189|NCT01244490|Secondary|Structure Side-Effect Questionnaire|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' on the checklist for each of the events listed. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|Safety Population|||participants|||Number
2700190|NCT01244490|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Safety Population defined as of randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
2700191|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF|The WFIRS-P Risk Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700192|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF|The WFIRS-P Social Domain is the mean of 7 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700204|NCT01244477|Secondary|PTSD Checklist (PCL)|An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.|Administered each week at weekly group sessions or pre-post treatment as usual|Veterans under 50 years of age diagnosed with PTSD|||PCL Scores||Standard Deviation|Mean
2700193|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF|The WFIRS-P Child Self-Concept Domain is the mean of 3 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700194|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF|The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700195|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF|The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700196|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF|The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700197|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF|The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700198|NCT01244490|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.|||units on a scale||Standard Deviation|Mean
2700199|NCT01244490|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.|||percentage of participants|||Number
2700200|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF|The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700201|NCT01244490|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF|The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
2700202|NCT01244490|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.|||percentage of participants|||Number
2700203|NCT01244490|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of investigational product. If more than 20% of the items used for summing a score were missing, the score was set to missing.|||units on a scale||Standard Error|Least Squares Mean
2725216|NCT01059682|Secondary|Blood Lipids, Lipoproteins||Throughout study, 24 months|Data not collected||||||
2700205|NCT01244477|Secondary|Behavioral Expression of Trust on the Trust Game|The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.|Pre & post a 12 week treatment group|Veterans with PTSD under 50 years of age|||Ratio||Standard Deviation|Mean
2700206|NCT01244477|Primary|The Clinician Administered PTSD Scale (CAPS)|The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.|Pre & post a 12 week treatment group|We limited this arm to 18 subjects who completed 9+ out of 12 treatment sessions.|||CAPS Scores||Standard Deviation|Mean
2700207|NCT01244477|Primary|Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan||Pre & post a 12 week treatment group|Neural data is not analyzable - scanner technicians changed the parameters of the task fMRI on an unpredictable basis. Project staff and data no longer available.||||||
2700208|NCT01244451|Secondary|Overall Survival|Patients still alive will be censored at the moment of last follow-up.|At 44 months from treatment start.||||participants|||Number
2700209|NCT01244451|Secondary|Progression Free Survival|Patients still alive and known to be progression-free will be censored at the moment of last follow-up. Patients disease progression will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.|Up to 32 months: from the date of first BendOfa treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first.||||Participants|||Count of Participants
2700210|NCT01244451|Secondary|Toxicity According to CTCAE Version 4.0|Number of patients experiencing 3 or >3 AEs (both hematological and not hematological)|At 44 months from treatment start.|Number of patients experiencing 3 or >3 Adverse Events (AEs) (both hematological and not hematological)|||participants|||Number
2700211|NCT01244451|Primary|Number of Participants Contributing to the Overall Response Rate|Patients response to treatment will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.|After 8 months from therapy start (6 months of treatment plus 2 months from the last course to response evaluation)||||participants|||Number
2700212|NCT01244425|Secondary|Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery||Within 48 hours after surgery|"Full analysis (data) set~Participants who received a drain and for whom the volume for the first 48 hours after surgery is available"|||mL||Full Range|Median
2700213|NCT01244425|Secondary|Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward|Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.|Intra- and postoperative until discharged from surgical ward|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
2700214|NCT01244425|Secondary|Percentage of Participants With Postoperative Rebleeding|Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration|Postoperative until discharged from surgical ward|Full analysis (data) set|||Percentage of participants||95% Confidence Interval|Number
2700215|NCT01244425|Secondary|Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis|Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.|Intraoperative day 0|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
2700216|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|10 minutes after start of treatment application|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
2700217|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|8 minutes after start of treatment application|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
2700218|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|6 minutes after start of treatment application|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
2700229|NCT01244035|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)|The effect of MK-8266 and placebo on changes in diastolic blood pressure (DBP) were assessed, as measured by time weighted average change from baseline in DBP over 0-24 hours postdose (TWA^0-24 hr) on Day 3. Baseline values for DBP are shown in the Baseline Characteristics section.|Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3|All participants who received at least one dose of the investigational drug and had DBP measurements.|||mmHg||Standard Deviation|Least Squares Mean
2725217|NCT01059682|Secondary|Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography||24 months||||mm||Standard Deviation|Mean
2700219|NCT01244425|Primary|Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application|"Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.~The following were regarded as treatment failures:~No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the time to hemostasis was used; a time window of +5 seconds was acceptable for showing a success)~Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required~Reapplication of FS VH S/D 500 s-apr after 4 minutes~Intraoperative rebleeding after the first 4 minutes of the observation period"|4 minutes post start of treatment application|full analysis (data) set (FAS)|||percentage of participants||95% Confidence Interval|Number
2700220|NCT01244412|Primary|Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera|"Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher.~Scale Image scored as follows~Unacceptable: cannot see fundus detail~Unacceptable: fundus detail visualized, but inadequate for meaningful analysis~Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use~Good: fundus detail visualized, meaningful analysis possible, std photo superior~Excellent: fundus detail visualized as well as std photo~Superior: fundus detail of higher quality than std photo"|estimated 3 months||||participants|||Number
2700221|NCT01244243|Primary|Arm Motor Fugl-Meyer Test|The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.|change from baseline to 1 month post-end treatment, Intention To Treat||||units on a scale||95% Confidence Interval|Mean
2700222|NCT01244243|Primary|Action Research Arm Test|The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.|change from baseline to 1 month post-end treatment, Intention To Treat||||units on a scale||95% Confidence Interval|Mean
2700223|NCT01244126|Secondary|Maximum PAED Score|"Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium.~1. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20."|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data|||units on a scale||Standard Deviation|Mean
2700224|NCT01244126|Primary|Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.|FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|Analysis was performed on per protocol basis excluding patients with protocol violations|||units on a scale||Standard Deviation|Mean
2700225|NCT01244061|Secondary|7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52|"The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the last 7 days questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit."|Weeks 12, 24 and 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
2700226|NCT01244061|Secondary|CAR From Week 9 Through Week 24|The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 24|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
2700227|NCT01244061|Secondary|CAR From Week 9 Through Week 52|The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
2700228|NCT01244061|Primary|Continuous Abstinence Rate (CAR) From Week 9 Through Week 12|The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.|Week 9 through Week 12|The Full Analysis Set (FAS) included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
2700230|NCT01244035|Primary|Change From Baseline in Heart Rate (HR)|The effect of MK-8266 and placebo on changes in HR were assessed, as measured by time weighted average change from baseline in HR over 0-24 hours postdose (TWA^0-24 hr) on Day 3. Baseline values for HR are shown in the Baseline Characteristics section.|Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3|All participants who received at least one dose of the investigational drug and had HR measurements|||Beats per minute||Standard Deviation|Least Squares Mean
2700231|NCT01244035|Primary|Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4|The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 4.|Predose and 2, 4, and 8 hours after dosing on Day 4 of each period|All participants who received at least one dose of the investigational drug and had assessment for Tmax|||Hours||Full Range|Median
2700232|NCT01244035|Primary|Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3|The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 1 and Day 3.|Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3|All participants who received at least one dose of the investigational drug and had assessment for Tmax|||Hours||Full Range|Median
2700233|NCT01244035|Primary|Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4|The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.|Predose and 2, 4, and 8 hours after dosing on Day 4 of each period|All participants who received at least one dose of the investigational drug and had assessment for Cmax|||nM||Standard Deviation|Mean
2700234|NCT01244035|Primary|Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3|The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.|Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3|All participants who received at least one dose of the investigational drug and had assessment for Cmax|||mg/mL||Standard Deviation|Mean
2700235|NCT01244035|Primary|Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4|The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.|Predose and 2, 4, and 8 hours after dosing on Day 4 of each period|All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)|||nM*hr||Standard Deviation|Mean
2700236|NCT01244035|Primary|Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3|The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.|Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each period|All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)|||nM*hr||Standard Deviation|Mean
2700237|NCT01244035|Primary|Adverse Events (AEs)|The number of participants with one or more clinical or laboratory AEs was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.|MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo|All participants who received at least one dose of study treatment|||Participants|||Count of Participants
2700238|NCT01243957|Secondary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Fluoxetine and Norfluoxetine|Tmax of fluoxetine and norfluoxetine was determined using the median of paired differences between the 2 treatment groups when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.|Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hours||90% Confidence Interval|Median
2700239|NCT01243957|Secondary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Fluoxetine and Norfluoxetine|The Least Squares (LS) geometric means Cmax of fluoxetine and norfluoxetine were determined when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of Cmax and the associated 90% confidence interval (CI) of the ratios were calculated.|Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
2700240|NCT01243957|Secondary|Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time-Curve Over a 24-Hour Dosing Interval (AUCτ) of Fluoxetine and Norfluoxetine|The Least Squares (LS) geometric means AUCτ of fluoxetine and norfluoxetine were calculated based on the fluoxetine and norfluoxetine plasma concentration time curves from time 0 hour (hr) to time 24 hr (tau [τ]) when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY22166684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of AUCτ and the associated 90% confidence interval (CI) of the ratios were calculated.|Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hour*nanogram per milliliter (h*ng/mL)||90% Confidence Interval|Least Squares Mean
2700241|NCT01243957|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684|Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.|Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hours||90% Confidence Interval|Median
2700320|NCT01243411|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2700242|NCT01243957|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684|The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.|Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
2700243|NCT01243957|Primary|Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684|The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.|Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27|The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.|||hour*nanogram per milliliter (h*ng/mL)||90% Confidence Interval|Least Squares Mean
2700244|NCT01243944|Secondary|Duration of The Overall Clinicohematologic Response|Duration of the overall clinicohematologic response was defined as the time from the first occurrence of complete response (CR) or partial response (PR) until the date of the first documented disease progression.|256 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of the overall clinicohematologic response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
2700245|NCT01243944|Secondary|Duration of Reduction in Spleen Volume|Duration of spleen volume reduction is defined as the time from the first occurrence of a >=35% reduction from baseline in spleen volume until the date of the first documented progression.|256 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of the reduction in spleen volume was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
2700246|NCT01243944|Secondary|Duration of the Absence of Phlebotomy Eligibility|Duration of the absence of phlebotomy eligibility is defined as the time from the first occurrence of absence of phlebotomy eligibility until the date of the first documented progression.|256 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of the absence of phlebotomy eligibility was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
2700247|NCT01243944|Secondary|Estimated Duration of the Complete Hematological Remission|"Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response).~Kaplan-Meier estimates are provided for duration of complete hematological remission."|Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
2700248|NCT01243944|Secondary|The Percentage of Participants Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48|Durable Complete or Partial Clinicohematologic Response was defined as any participant who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants|||Number
2700249|NCT01243944|Secondary|The Percentage of Participants Who Achieved Overall Clinicohematologic Response at Week 32|Overall Clinicohematologic Response is defined as any participant who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.|32 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants|||Number
2700250|NCT01243944|Secondary|Estimated Duration of the Primary Response|"Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response).~Kaplan-Meier estimates are provided for duration of primary response."|Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
2700251|NCT01243944|Secondary|The Percentage of Participants Who Achieved Durable Spleen Volume Reduction at Week 48|Durable Spleen Volume Reduction was defined as a participant who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
2700321|NCT01243411|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.|||participants|||Number
2700252|NCT01243944|Secondary|The Percentage of Participants Who Achieved a Durable Hematocrit Control at Week 48|Durable Hematocrit Control was defined as any participant who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
2700253|NCT01243944|Secondary|The Percentage of Participants Who Achieved a Durable Complete Hematological Remission at Week 48|Durable Complete Hematological Remission was defined as any participant who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
2700254|NCT01243944|Secondary|The Percentage of Participants Achieving Complete Hematological Remission at Week 32|Complete Hematological Remission at Week 32 was defined as any participant who achieved hematocrit control with a platelet count less than or equal to 400 X 10^9/L and a white blood cell count less than or equal to 10 X 10^9/L.|32 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
2700255|NCT01243944|Secondary|The Percentage of Participants Achieving a Durable Primary Response at Week 48|Durable Primary Response was defined as any participant who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
2700256|NCT01243944|Primary|The Percentage of Participants Achieving a Primary Response at Week 32|Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32).|32 Weeks|Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
2700257|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy|The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.|Month 12 to Month 24 (Year 1 to Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.||||||
2700258|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment|The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.|Baseline up to Month 12 (Year 1)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.||||||
2700259|NCT01243892|Primary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment|The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.|Baseline up to Month 24 (Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.||||||
2700260|NCT01243775|Secondary|Neutropenia Grade 3-4|Toxicity (CECAE ver 4.0) and Safety|2 years||||participants|||Number
2700261|NCT01243775|Secondary|Overall Survival||2 years||||months||95% Confidence Interval|Median
2700262|NCT01243775|Secondary|Progression Free Survival||2 years||||months||95% Confidence Interval|Median
2700263|NCT01243775|Primary|Response Rate|RECIST version 1.1|6th week|Intention to treat population|||participants|||Number
2700264|NCT01243762|Secondary|Number of Participants Whose Best Response is a Partial Response (PR) or Complete Response (CR)|Best response was determined for the maximum tolerated dose from the start of treatment until disease progression, recurrence, or completion of 6 months of treatment. Lesions were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI). Partial response (PR), defined as a tumor burden decrease of 30%, or complete response (CR) was determined using Response Criteria in Solid Tumors (RECIST) 1.1 for participants with at least one measurable target lesion at baseline.|Up to 7 months|All participants who received at least one dose of study therapy and had baseline data for those analyses that required baseline data. The analysis was planned to be performed on the 3 arms in Part 2 only. The study was terminated prior to completion of this analysis.|||Participants|||Number
2700265|NCT01243762|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs were defined as follows: 1) non-hematological toxicity ≥Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except for Grade 3 nausea, vomiting, diarrhea, and/or dehydration; Grade 3 or 4 hyperglycemia; alopecia; inadequately treated hypersensitivity reactions; dalotuzumab infusion-related reactions; Grade 3 transaminases ≤1 week in duration; or clinically non-significant, treatable or reversible lab abnormalities; 2) Grade 4-5 hematologic toxicity, with the exception of Grade 4 neutropenia <6 days in duration; 3) Grade 3 or Grade 4 neutropenia with fever >38.5 degrees C; 4) Grade 4 thrombocytopenia ≤25.0 x 10^9/Liter; 5) drug-related adverse experience leading to a dose modification during Cycle 1; 6) unresolved drug-related toxicity that causes ≥3 week delay of the next scheduled dose of study medication; 7) persistent increases in QTc interval >60 milliseconds from baseline, or clinically significant bradycardia.|Cycle 1-28 Days|All participants who completed the first cycle of study therapy or discontinued from the study due to a DLT attributable to study therapy.|||Participants|||Number
2700266|NCT01243671|Secondary|Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52|C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.|||mg/dL||Standard Deviation|Mean
2700344|NCT01243320|Primary|Change In Hematocrit Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
2700267|NCT01243671|Secondary|Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.|||units on a scale||Standard Deviation|Mean
2700268|NCT01243671|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.|||units on a scale||Standard Deviation|Mean
2700269|NCT01243671|Secondary|Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52|Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared).|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700270|NCT01243671|Secondary|Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Improvement of ≥1 grade from baseline is also presented.|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700271|NCT01243671|Secondary|Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52|Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700272|NCT01243671|Secondary|Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Study participants completed a global assessment of their gastrointestinal symptoms (Behçet's disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700273|NCT01243671|Secondary|Number of Participants With Complete Remission at Week 24 and Week 52|Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700286|NCT01243580|Primary|Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700274|NCT01243671|Secondary|Number of Participants With Marked Improvement at Week 52|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700275|NCT01243671|Primary|Number of Participants With Marked Improvement at Week 24|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
2700276|NCT01243619|Other Pre-specified|Analyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment.|We will compare the findings of FDG and FLT PET scans at pre-treatment, mid-treatment and post-treatment time points to determine how closely they correlate with each other, and if there is a specific time point at which any observed differences between FDG and FLT PET scans are most pronounced. We will also determine which of the six PET scans may correlate most closely with the response to treatment as determined by pathologic findings at esophagectomy.|1 year|||||||
2700277|NCT01243619|Primary|Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis|Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.|1 year||||participants|||Number
2700278|NCT01243580|Primary|Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3|Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700279|NCT01243580|Primary|Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3|Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3.|3 months|Primary PK population|||ng.h/ml||Standard Deviation|Mean
2700280|NCT01243580|Primary|Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3|Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700281|NCT01243580|Primary|Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700282|NCT01243580|Primary|Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700283|NCT01243580|Primary|Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700284|NCT01243580|Primary|Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700285|NCT01243580|Primary|Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
2700291|NCT01243567|Secondary|Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2700292|NCT01243567|Secondary|Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2700293|NCT01243567|Secondary|Percentage of Patients Reaching a Predefined Target Pressure Threshold|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.|Baseline, Month 3|Intent to Treat: all randomized patients.|||Percentage of Patients|||Number
2700294|NCT01243567|Secondary|Change From Baseline IOP|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2700295|NCT01243567|Primary|Change From Baseline in Average Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2700296|NCT01243450|Primary|Acne Lesion Percent Reduction|Reduction in number of Acne lesions by counting over 12 weeks|12 week||||percent reduction of number of lesions||Standard Deviation|Mean
2700297|NCT01243424|Secondary|CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study|Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.|Baseline|The sub-study was stopped early and required target with an estimated time point of 432 weeks was not achieved for this endpoint. Thus the data were not unblinded and only the baseline data collected were reported overall and not by treatment arm for this endpoint.|||Millimoles/ Litre (mmol/L)||Standard Deviation|Mean
2700298|NCT01243424|Secondary|Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study|Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.|Baseline|The sub-study was stopped early and required target with an estimated time point of 432 weeks was not achieved for this endpoint. Thus the data were not unblinded and only the baseline data collected were reported overall and not by treatment arm for this endpoint.|||Milligrams/ deciliter (mg/ dL)||Standard Deviation|Mean
2700299|NCT01243424|Secondary|Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up|Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint.|433 weeks|Full analysis set cognition(FAS-COG): Randomised and treated patients with one dose of study drug, baseline assessment (the z-scores, A&E or Mini-mental state examination(MMSE) can be calculated), years of formal education with baseline MMSE≥24 and at least one on-treatment assessment (of which at least one of the RBI scores can be calculated).|||Percentage of participants (%)||95% Confidence Interval|Number
2700300|NCT01243424|Secondary|Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks|The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint.|Baseline and week 208|Meal tolerance test(MTT) last observation carried forward(LOCF) set: Randomised and treated patients with one dose of study drug and signed the sub-study Informed Consent with valid baseline and on-treatment MTT. If values taken after rescue medication intake will be set to missing, last observed on-treatment value was carry forwarded.|||Picomol/ minute/meter^2 (pmol/min/m²)||Standard Error|Mean
2700301|NCT01243424|Secondary|Percentage of Participants With Transition in Albuminuria Classes|Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented.|Baseline and week 432|TS w/o duplicates, participants on treatment|||Percentage of participants (%)|||Number
2700302|NCT01243424|Secondary|Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)|Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates, participants on treatment|||mg/ gcrea||Geometric Coefficient of Variation|Geometric Mean
2700303|NCT01243424|Secondary|Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)|Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates, participants on treatment|||mL/minute/1.73 meter^2||Standard Error|Least Squares Mean
2700306|NCT01243424|Secondary|Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol|Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates, participants on treatment|||mg/dL||Standard Error|Least Squares Mean
2700307|NCT01243424|Secondary|Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)|Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates considering all available data|||Milligram/ deciliter (mg/dL)||Standard Error|Least Squares Mean
2700308|NCT01243424|Secondary|Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)|Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.|Baseline and week 432|TS w/o duplicates considering all available data|||Percentage glycosylated hemoglobin (%)||Standard Error|Least Squares Mean
2700309|NCT01243424|Secondary|Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events|"Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:~CV death (including fatal stroke and fatal MI)~non-fatal MI~non-fatal stroke~hospitalisation for unstable angina pectoris~Transient ischaemic attack (TIA)~hospitalisation for heart failure~hospitalisation for coronary revascularisation procedures (CABG, PCI)"|From start of the treatment until 7 days after the end of treatment, up to 433 weeks|TS|||Events/ 1000 patients-years|||Number
2700310|NCT01243424|Secondary|Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events|"Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:~CV death (including fatal stroke and fatal MI)~non-fatal MI~non-fatal stroke~hospitalisation for unstable angina pectoris~TIA~hospitalisation for heart failure~hospitalisation for coronary revascularisation procedures (CABG, PCI)"|From start of the treatment until 7 days after the end of treatment, up to 433 weeks|TS|||Percentage of participants (%)||95% Confidence Interval|Number
2700311|NCT01243424|Secondary|Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE|Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint.|From randomization until individual day of trial completion, up to 432 weeks|TS|||Percentage of participants (%)||95% Confidence Interval|Number
2700312|NCT01243424|Secondary|Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE|Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint.|From randomization until individual day of trial completion, up to 432 weeks|TS|||Percentage of participants (%)||95% Confidence Interval|Number
2700313|NCT01243424|Secondary|Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase|The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase.|From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)|TS w/o duplicates (NCF)|||Percentage of participants (%)||95% Confidence Interval|Number
2700314|NCT01243424|Secondary|Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase|The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase.|From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)|TS without duplicates (TS w/o duplicates), patients who are off-drug or died prior to regular study stop were handled as non-completers considered failure (NCF).|||Percentage of participants (%)||95% Confidence Interval|Number
2700315|NCT01243424|Secondary|The First 4-point (4P)− MACE|The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris.|From randomization until individual day of trial completion, up to 432 weeks|TS|||Events/ 1000 patients-years|||Number
2700316|NCT01243424|Primary|The First 3-point Major Adverse Cardiovascular Events (3P−MACE)|The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.|From randomization until individual day of trial completion, up to 432 weeks|Treated set (TS): All patients treated with at least one dose of trial drug.|||Events/ 1000 patients-years|||Number
2700317|NCT01243411|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.|||centimeters||Standard Deviation|Mean
2700318|NCT01243411|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.|||participants|||Number
2700345|NCT01243320|Primary|Change In Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||gm/dL||95% Confidence Interval|Mean
2700322|NCT01243411|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
2700323|NCT01243411|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2700324|NCT01243411|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2700325|NCT01243411|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on the modified intent-to-treat (mITT) population.|||percentage of curvature change||Standard Deviation|Mean
2700326|NCT01243333|Primary|Standard Therapeutic Response|The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). Percent change in lesion measurements according to standard response criteria for the patient's tumor type were obtained. For brain tumors, Response Assessment in Neuro-Oncology (RANO) criteria were used. Partial Response (PR) was defined as 50% or greater reduction in lesion measurements, Progressive Disease (PD) was 25% or greater increase in measurements, and Stable Disease (SD) was neither PD or PR. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria were used for solid tumors, with PR defined as 30% or greater reduction in measurements, PD was 20% or greater increase in measurements, and SD was all other changes.|1-2 cycles of treatment - approximately one month||||Participants|||Count of Participants
2700327|NCT01243333|Primary|FLT Therapeutic Response|The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). The percent change in the SUVmax for FLT was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.|1-2 cycles of treatment - approximately one month||||Participants|||Count of Participants
2700328|NCT01243333|Primary|FDG Therapeutic Response|The patients underwent baseline and repeat PET/CT imaging (after one to two cycles of treatment) with [F-18]fluorodeoxyglucose (FDG) and [F-18]fluorothymidine (FLT). The percent change in the SUVmax for FDG was calculated and used to determine the response. Partial response (PR) was defined as 35% or greater reduction in SUVmax, Progressive Disease (PD) was defined as 35% or greater increase in SUVmax, and Stable Disease (SD) was defined as all other changes in SUVmax.|1-2 cycles of treatment - approximately one month||||Participants|||Count of Participants
2700329|NCT01243320|Primary|Change in Quinone Oxidoreductase 1 Gene|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
2700330|NCT01243320|Primary|Change in Monocyte Chemotactic Protein 1|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
2700331|NCT01243320|Primary|Change to Interleukin-1 Beta Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
2700332|NCT01243320|Primary|Change to Interleukin-1 Alpha Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
2700333|NCT01243320|Primary|Change to Interleukin-8 Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
2700334|NCT01243320|Primary|Sputum Reactive Oxygen Species Change|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||uM||95% Confidence Interval|Mean
2700335|NCT01243320|Primary|Change in Eosinophil Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
2700336|NCT01243320|Primary|Change in Basophils Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
2700337|NCT01243320|Primary|Change In Monocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
2700338|NCT01243320|Primary|Change In Lymphocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
2700339|NCT01243320|Primary|Change In Granulocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
2700340|NCT01243320|Primary|Change In Platelet Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||k/uL||95% Confidence Interval|Mean
2700341|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days||||gm/dL||95% Confidence Interval|Mean
2700342|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||pg||95% Confidence Interval|Mean
2700343|NCT01243320|Primary|Change In Mean Corpuscular Volume Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days||||fL||95% Confidence Interval|Mean
2700365|NCT01243294|Secondary|Wear Time (Registered by Subject When Applying and Removing a Product)|Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Hours|Participants|Standard Deviation|Mean
2700366|NCT01243294|Secondary|Comfort (Subjects Own Assessment)|"Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.~Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.~Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Percent of participants|||Number
2700367|NCT01243294|Secondary|Handling at Appliance (Subjects Own Assessment)|"Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.~Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.~Unit of measure is: Percentage of participants answering 'very easy' and 'easy'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Percent of participants|||Number
2700368|NCT01243294|Secondary|Security (Subjects Own Assessment)|"Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.~Unit of measure is: Percentage of participants answering 'very good'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Percent of participants|||Number
2700369|NCT01243294|Secondary|Adverse Events|Safety is evaluated by adverse events occuring continues while the subjects are testing the devices|During the investigation ~ 24 days per subject|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Adverse events|||Number
2700370|NCT01243294|Primary|Leakage (Percent of All Base Plates With Leakage)|Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device|||Percent of Base plates|Participants||Number
2700371|NCT01243268|Secondary|Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.|Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP < 130/80 mmHg is presented|8±2 weeks|An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)|||percentage of participants||95% Confidence Interval|Number
2700372|NCT01243268|Secondary|Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP ＜ 140 mmHg or a Reduction of Over 10 mmHg)|Percentage of subjects who achieved SBP response (defined as mean sitting SBP ＜ 140 mmHg or a reduction of over 10 mmHg) is presented|8±2 weeks|An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)|||percentage of participants||95% Confidence Interval|Number
2700373|NCT01243268|Secondary|Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP ＜ 90 mmHg or a Reduction of Over 10 mmHg)|Percentage of subjects who achieved DBP response (defined as mean sitting DBP ＜ 90 mmHg or a reduction of over 10 mmHg) is presented|8±2 weeks|An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)|||percentage of participants||95% Confidence Interval|Number
2700374|NCT01243268|Primary|Percentage of Subjects With Adverse Events|Percentage of subjects with adverse events is presented. Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)|Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)|Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016).|||percentage of participants||95% Confidence Interval|Number
2700375|NCT01243268|Secondary|Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) ＜ 140/90 mmHg)|Percentage of subjects who had achieved normal blood pressure (SBP/DBP ＜ 140/90 millimeters of mercury (mmHg))is presented|8±2 weeks|An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)|||percentage of participants||95% Confidence Interval|Number
2700376|NCT01243242|Secondary|Clinical Global Impression Scale (CGI-I)Score|"The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 ('very much improved') through to 7 ('very much worse').~During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."|6 weeks from visit 1 baseline to visit 6|"The ITT population included all randomized subjects who completed at least one post-randomization visit.~During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."|||units on a scale||Standard Deviation|Mean
2700377|NCT01243242|Secondary|Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6|The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from 'Not at all/Never' (1) to 'Extremely/Very Often' (5).|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit|||units on a scale||Standard Deviation|Mean
2700378|NCT01243242|Secondary|Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)|The TOVA is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.|6 weeks( visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.|||Z score||Standard Deviation|Mean
2700379|NCT01243242|Primary|Conners' Adult ADHD Rating Scales (CAARS™)|The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 ('Not at all', 'never') to 3 ('Very much', 'very frequently'). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.|||units on a scale||Standard Deviation|Mean
2700380|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)|"An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose."|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.|||Participants|||Number
2700381|NCT01243177|Secondary|Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.|12 consecutive months of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.|||percentage of subjects||95% Confidence Interval|Number
2700382|NCT01243177|Primary|Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.|||Participants|||Number
2700383|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.|||Participants|||Number
2700398|NCT01243151|Secondary|Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Baseline, Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700384|NCT01243177|Primary|Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment|The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.|||percentage of subjects||95% Confidence Interval|Number
2700385|NCT01243177|Primary|Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.|||percentage of subjects||95% Confidence Interval|Number
2700386|NCT01243151|Secondary|Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nm||Standard Deviation|Mean
2700387|NCT01243151|Secondary|High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nm||Standard Deviation|Mean
2700388|NCT01243151|Secondary|Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700389|NCT01243151|Secondary|Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700390|NCT01243151|Secondary|Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700391|NCT01243151|Secondary|Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700392|NCT01243151|Secondary|Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||umol/L||Standard Deviation|Mean
2700393|NCT01243151|Secondary|Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||umol/L||Standard Deviation|Mean
2700394|NCT01243151|Secondary|Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||umol/L||Standard Deviation|Mean
2700395|NCT01243151|Secondary|Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||micromole/liter (umol/L)||Standard Deviation|Mean
2700396|NCT01243151|Secondary|C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78||Day 8, 15, 21, 36, 57 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700397|NCT01243151|Secondary|Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78||Baseline, Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population was defined as all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter.|||ng/mL||Standard Deviation|Mean
2700505|NCT01241604|Secondary|Hypopnea Index|The hypopnea index is number hypopneas per hour.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||events per hour||Standard Deviation|Mean
2700399|NCT01243151|Secondary|Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Baseline, Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700400|NCT01243151|Secondary|Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Baseline, Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nmol/L||Standard Deviation|Mean
2700401|NCT01243151|Secondary|Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78||Baseline, Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2700402|NCT01243151|Secondary|Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78||Baseline, Day 8, 15, 22, 36, 50, 64 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nanometer (nm)||Standard Deviation|Mean
2700403|NCT01243151|Secondary|Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||percent change||Standard Deviation|Mean
2700404|NCT01243151|Secondary|Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||percent change||Standard Deviation|Mean
2700405|NCT01243151|Secondary|Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter.|||percent change||Standard Deviation|Mean
2700406|NCT01243151|Secondary|Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||percent change||Standard Deviation|Mean
2700407|NCT01243151|Secondary|Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||percent change||Standard Deviation|Mean
2700408|NCT01243151|Secondary|Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||percent change||Standard Deviation|Mean
2700409|NCT01243151|Secondary|Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700410|NCT01243151|Secondary|Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700411|NCT01243151|Secondary|Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700412|NCT01243151|Secondary|Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700413|NCT01243151|Secondary|Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700414|NCT01243151|Secondary|Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||mg/dL||Standard Deviation|Mean
2700415|NCT01243151|Secondary|Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline||Baseline, Day 15, 22, 29 and 36|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2700416|NCT01243151|Secondary|Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL)||Day 15, 22, 29 and 36|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||Participants|||Count of Participants
2700417|NCT01243151|Secondary|Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL)||Day 15, 22, 29 and 36|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||Participants|||Count of Participants
2700418|NCT01243151|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78||Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||percent change||Standard Deviation|Mean
2700419|NCT01243151|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78||Baseline, Day 8, 15, 22, 29 and 78|Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2700420|NCT01243151|Secondary|Accumulation Ratio (Rac) of PF-04950615|Rac was calculated as Day 22 AUCtau divided by Day 1 AUCtau, where AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours.|Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2700421|NCT01243151|Secondary|Volume of Distribution at Steady State (Vss) of PF-04950615|Vss was calculated as CL*MRT. CL was calculated as Dose/AUCtau, where AUCtau was area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau=168 hours. MRT was mean residence time (predicted) extrapolated to infinity.|Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2700422|NCT01243151|Secondary|Apparent Clearance (CL) of PF-04950615|CL was calculated as Dose/AUCtau. AUCtau is area under the concentration-time profile from time zero to time tau, the dosing interval, where tau=168 hours.|Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||milliliter per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
2700423|NCT01243151|Secondary|Plasma Decay Half-Life (t1/2) of PF-04950615|t1/2 was the time measured for the plasma concentration of PF-04950615 to decrease by one half. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||hour||Standard Deviation|Mean
2700424|NCT01243151|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04950615||Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2700425|NCT01243151|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615|Tmax is the time at which maximum plasma concentration (Cmax) occurred.|Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||hour||Full Range|Median
2700426|NCT01243151|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615|AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours.|Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.|||nanogram*hour/ milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2702105|NCT01229111|Secondary|Tabulation of the Toxicity Profile of the Combination Therapy|Number of patients that experienced >/= grade 3 treatment related toxicities (definite, probable, possible).|Up to 3 years|All patients that received treatment drug|||participants|||Number
2700427|NCT01243151|Primary|Number of Participants With Anti-drug Antibodies (ADA)|The number of participants with at least one positive ADA were summarized for each treatment arm. Participants with positive antibody titer of >4.32 milligram/milliliter (mg/mL) were considered as ADA positive.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug. Only the participants who received a dose of PF-04950615 0.25, 0.50, 1.0, and 1.50 mg/kg were planned to be analysed for this outcome measure.|||participants|||Number
2700428|NCT01243151|Primary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters|Criteria for clinically relevant ECG parameters: PR interval: maximum IFB of >=25 percent or 50 percent; QRS complex: maximum IFB of >=25 or 50 percent; QTcF interval (Fridericia's Correction): maximum IFB of >=30 millisecond (msec) to <60 msec and maximum IFB of >=60 msec.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2700429|NCT01243151|Primary|Number of Participants With Clinically Relevant Changes in Vital Signs|Criteria for clinically relevant vital signs: supine and standing systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg); supine and standing diastolic blood pressure (DBP): <50 mmHg. Maximum increase from baseline (IFB) or decrease from baseline (DFB) in supine and standing SBP: greater than or equal to (>=) 30 mmHg and maximum IFB or DFB in supine and standing DBP: >=20 mmHg. Supine pulse rate: <40 and greater than (>) 120 beats per minute (bpm); standing pulse rate: <40 and >140 bpm.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2700430|NCT01243151|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria: Haemoglobin(Hgb), hematocrit, RBC: <0.8*lower limit of normal(LLN),mean corpuscular volume, mean corpuscular Hgb concentration <0.9*LLN or>1.1*upper limit of normal(ULN), platelet<0.5*LLN or>1.75*ULN, WBC<0.6*LLN or>1.5*ULN, lymphocyte, neutrophil<0.8*LLN or>1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN; bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, lactate dehydrogenase>3.0*ULN,total protein,albumin<0.8*LLN or>1.2*ULN; blood urea nitrogen, creatinine>1.3*ULN,uric acid>1.2*ULN;sodium<0.95*LLNor>1.05*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN or>1.1*ULN; glucose<0.6*LLN or >1.5*ULN, urine specific gravity<1.003 or>1.030,urine pH<4.5or>8,urine glucose, ketones, urine protein,urine blood/Hgb,urobilinogen,bilirubin,nitrite, leukocyte esterase>=1; urine RBC,WBC>=20,urine epithelial cells>=6,urine granular casts,hyaline casts>1,urine bacteria>20,partial thromboplastin time,prothrombin:>1.1*ULN.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2700431|NCT01243151|Primary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug. AE was assessed according to common terminology criteria for adverse events (CTCAE) version 4.0 severity grades- Grade 1: mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2: moderate (minimal, local or non invasive intervention indicated); Grade 3: severe (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling); Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to AE.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2700432|NCT01243151|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 78 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2700433|NCT01243151|Primary|Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding.|Baseline up to Follow-up period (Day 78)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2700434|NCT01243112|Primary|Onset of Action|Time from infusion of local anesthetic to loss of sensation to sharp.|Up to 5 minutes||||second||Standard Deviation|Mean
2700435|NCT01243112|Primary|Length of Action|The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.|Up to 12 hours|A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.|||minutes||Standard Deviation|Mean
2700436|NCT01242813|Secondary|Number of Participants With Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.|||Number of participants|||Number
2700437|NCT01242813|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL).|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||pg/mL||Standard Deviation|Mean
2700712|NCT01240785|Secondary|Pregnancy Induced Hypertension Per Arm|Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg|up to on the average 40 weeks of gestation||||participants|||Number
2700438|NCT01242813|Secondary|Serum Concentration of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug.|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||microgram(s)/milliliter||Standard Deviation|Mean
2700439|NCT01242813|Secondary|Percentage of Participants Who Relapsed and Received Rescue Medication|Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication.|Day 85 to Day 953 (End of treatment period to End of study)|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
2700440|NCT01242813|Secondary|Time to Relapse After Last Dose of Canakinumab|Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 85 to Day 253 (End of treatment period to Follow-up period)|The analysis was performed on the FAS population.|||Days||95% Confidence Interval|Median
2700441|NCT01242813|Secondary|Percentage of Relapsed Participants|Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
2700442|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Participant's Global Assessment Score|Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 253 (End of follow-up period)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2700443|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Physician's Global Assessment Score|Participants were assessed based by physician on Physician's Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 953 (End of study)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2700444|NCT01242813|Secondary|Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain|TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician's global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 113 (end of treatment period) up to Day 925 (End of study)|The analysis was performed on the FAS population.|||Percentage of participants|||Number
2700445|NCT01242813|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.|||Percent change||Full Range|Median
2700446|NCT01242813|Secondary|Time to Participant's Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.|||Days||95% Confidence Interval|Median
2700447|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8|Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician's Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA < 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA).|Day 15|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2700448|NCT01242813|Secondary|Time to Physician's Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician's Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.|||Days||95% Confidence Interval|Median
2700449|NCT01242813|Secondary|Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L.|Day 8 and Day 15|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
2700450|NCT01242813|Secondary|Percentage of Participants With Complete Clinical Remission at Day 8 and 15|Complete clinical remission was defined as Physician's Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 8 and Day 15|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
2700451|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 8|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA < 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA).|Day 8|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
2700452|NCT01242813|Primary|Percentage of Participants With Complete or Almost Complete Response at Day 15|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than [≥] 70% reduction of baseline CRP and/or SAA).|Day 15|The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy.|||Percentage of participants||95% Confidence Interval|Number
2700453|NCT01242748|Secondary|Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin|Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||ng/mL||Full Range|Median
2700454|NCT01242748|Secondary|Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin|Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||ng/mL||Full Range|Median
2700455|NCT01242748|Secondary|Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin|The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of deaths||95% Confidence Interval|Number
2700456|NCT01242748|Secondary|Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin|Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no additional therapy||95% Confidence Interval|Number
2700457|NCT01242748|Secondary|Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin|Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no testosterone escape||95% Confidence Interval|Number
2700458|NCT01242748|Secondary|Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no PSA failure||95% Confidence Interval|Number
2700459|NCT01242748|Secondary|Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no PFS failure||95% Confidence Interval|Number
2700460|NCT01242748|Primary|Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin|PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no PSA-PFS||95% Confidence Interval|Number
2700461|NCT01242527|Primary|Fasting Serum Triglycerides|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups|12 weeks|The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented.|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
2700462|NCT01242514|Secondary|Mean HAQ-DI Score|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Units on a scale||Standard Deviation|Mean
2700463|NCT01242514|Secondary|Mean mTSS Score|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily|Weeks 0 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Units on a scale||Standard Deviation|Mean
2700464|NCT01242514|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study (variable duration; maximum 109 weeks)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Percentage of patients|||Number
2700465|NCT01242514|Secondary|Mean DAS28-CRP Score|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Units on a scale||Standard Deviation|Mean
2700466|NCT01242371|Secondary|Measurement of Gliadin and Casein Antibody Levels||16 weeks (baseline prior to placebo run in to week 14)|||||||
2700467|NCT01242371|Secondary|Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14|"Self report rating of difficulty moving bowels on a 4 point scale from no difficulty to severe difficulty"|14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)|||||||
2700468|NCT01242371|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.|14 weeks (week 0 to week 14)|Week 0 data is based on the number of participants in the probiotic supplement group (n=33) and the placebo group (n=32) who began the treatment phase. Week 14 data is based on the number of participants in the probiotics supplement group (n=31) and the placebo group (n=27) who completed the treatment phase.|||units on a scale||Standard Deviation|Mean
2700469|NCT01242176|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Standard Deviation|Mean
2700470|NCT01242176|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Standard Deviation|Mean
2700471|NCT01242176|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the coefficient of variation (CV (%))."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Standard Deviation|Mean
2700472|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Forced Vital Capacity.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage change||Standard Deviation|Mean
2700473|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage change||Standard Deviation|Mean
2700474|NCT01242111|Secondary|Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 168 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage change||Standard Deviation|Mean
2700475|NCT01242111|Secondary|Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in the 3-minute Stair Climb Test (3MSCT). Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.|||steps/min||Standard Deviation|Mean
2700476|NCT01242111|Secondary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.|||meters||Standard Deviation|Mean
2700477|NCT01242111|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).~The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 240 weeks|The primary outcome measure data is presented in more detail under the Adverse Events section.|||participants|||Number
2700478|NCT01242085|Primary|Alignment of Knee - Measured Mechanical Axis From CT Data|the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment|postoperatively - CT done within 1 week of surgery|all participants who completed the study|||degrees||95% Confidence Interval|Mean
2700479|NCT01242085|Secondary|Surgical Time|the difference between the average surgical time will be determined and compared with 95% CI|intraoperative surgical time|particpants who completed study|||delta between means in minutes||95% Confidence Interval|Mean
2700480|NCT01242020|Secondary|Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues||up to 30 days|Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal muscle microvascular flow were not be collected for this outcome measure.||||||
2700481|NCT01242020|Primary|Variability of Repeated Measures for Each Subject|The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow.|up to 30 days|Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal microvascular flow were not collected for the Outcome Measure.||||||
2700482|NCT01241916|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|12 months||||units on a scale||Full Range|Mean
2700483|NCT01241916|Primary|Change in Arc of Flexion and Extension|Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.|baseline and 6 months||||Degrees||Full Range|Mean
2700484|NCT01241903|Secondary|Biomarkers of Platelet Function and Myocardial Necrosis||up to 30 days|||||||
2700485|NCT01241903|Primary|Platelet - Leukocyte Aggregates|measured by flow cytometry|within first 24 hours||||% leukocytes with platelets attached||Standard Error|Mean
2700486|NCT01241760|Secondary|Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)|The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.|End of trial, 12 weeks after the last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
2700487|NCT01241760|Secondary|Percentage of Participants Who Relapsed During Follow-up Period|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug)|The analysis was performed on subjects with HCV RNA <25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.|||percentage of participants|||Number
2700488|NCT01241760|Secondary|Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs|The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.|Week 4, 12, 24, 32, 40|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants|||Number
2700489|NCT01241760|Secondary|Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.|Baseline, Week 4 and Week 4+12.|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
2700506|NCT01241604|Secondary|Mixed Apnea Index|The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||events per hour||Standard Deviation|Mean
2700490|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)|The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).|End of trial, 72 weeks after the start of study medication|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
2700491|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)|The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.|End of trial, 24 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
2700492|NCT01241760|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)|The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).|End of trial, 12 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
2700493|NCT01241604|Secondary|Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.|The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.|2 nights|The Apnea Hypopnea Index (AHI) was analyzed and results were provided. However the epochs were not separated out as this is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.||||||
2700494|NCT01241604|Secondary|Apnea Hypopnea Index Using Modified Hypopnea Rule.|The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.|2 nights|The Apnea Hyopnea Index(AHI) was analyzed and results were provided. The AHI using the modified hypopnea rule was not conducted. This is not part of the standard sleep scoring and therefore was not completed. The was an error in the endpoint analysis.||||||
2700495|NCT01241604|Secondary|Nocturnal Oxygenation Index|Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||oxygen saturation index||Standard Deviation|Mean
2700496|NCT01241604|Secondary|Stages N1,N2,N3 and REM (R) Sleep (in Minutes)|The average amount of time spent N1, N2, N3 and REM in minutes per night.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||minutes||Standard Deviation|Mean
2700497|NCT01241604|Secondary|Stages N1,N2,N3 and REM (R) Sleep (% TST)|The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||percentage of TST per night||Standard Deviation|Mean
2700498|NCT01241604|Secondary|Arousal Index|The arousal index is the number of arousals or awakenings per hour of sleep.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||arousals per hour||Standard Deviation|Mean
2700499|NCT01241604|Secondary|Periodic Limb Movement Index|The periodic limb movement is the number of periodic limb movements per hour of sleep.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||movements per hour||Standard Deviation|Mean
2700500|NCT01241604|Secondary|Sleep Efficiency|Sleep Efficiency is the percentage of time spent asleep while in bed.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||percentage of time asleep||Standard Deviation|Mean
2700501|NCT01241604|Secondary|Total Sleep Time|Total Sleep time is total amount of time a participant is asleep from lights off to lights on.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||minutes||Standard Deviation|Mean
2700502|NCT01241604|Secondary|Wake After Sleep Onset|Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||minutes||Standard Deviation|Mean
2700503|NCT01241604|Secondary|REM Onset Latency|REM Onset Latency is the time it takes to fall into REM sleep.|2 nights|This analysis was not done because this is not a standard measurement.||||||
2700504|NCT01241604|Secondary|Sleep Onset Latency|Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||minutes||Standard Deviation|Mean
2700507|NCT01241604|Secondary|Obstructive Apnea Index|The obstructive apnea index is the number of obstructive apneas per hour of sleep.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||events per hour||Standard Deviation|Mean
2700508|NCT01241604|Secondary|Central Apnea Index|The central apnea index is the number of central apneas divided by the number of hours of sleep.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||events per hour||Standard Deviation|Mean
2700509|NCT01241604|Secondary|Apnea Hypopnea Index- REM|The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||events per hour||Standard Deviation|Mean
2700510|NCT01241604|Primary|Apnea Hypopnea Index|The number of apneas and hypopneas per hour of sleep.|2 nights|"One subject was excluded from analysis due to the subject chewing during the treatments causing the data to be unreliable.~One subject had no pain related medical history and therefore was excluded from analysis."|||events per hour||Standard Deviation|Mean
2700511|NCT01241591|Secondary|Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Week 12|FAS; OC|||scores on a scale||Standard Error|Mean
2700512|NCT01241591|Secondary|Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
2700513|NCT01241591|Secondary|Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.|Week 12|FAS; OC|||percentage of participants|||Number
2700514|NCT01241591|Secondary|Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.|Baseline and Week 12|FAS; OC|||percentage of participants|||Number
2700515|NCT01241591|Secondary|Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment||Week 12|FAS; OC|||percentage of participants|||Number
2700516|NCT01241591|Secondary|Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.|Baseline (BL) and Week 12|FAS; OC|||percentage of participants|||Number
2700517|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Week 12|FAS; OC|||scores on a scale||Standard Error|Mean
2700518|NCT01241591|Secondary|Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 12|FAS; OC|||Units on a scale||Standard Error|Mean
2700519|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D VAS at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Week 12|FAS; OC|||mm||Standard Error|Mean
2700520|NCT01241591|Secondary|Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 12|FAS; OC|||mm||Standard Error|Mean
2700713|NCT01240785|Primary|Birth Weight Per Arm|birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies|delivery||||g||Standard Deviation|Mean
2700521|NCT01241591|Secondary|Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Week 12|FAS; OC|||scores on a scale||Standard Error|Least Squares Mean
2700522|NCT01241591|Secondary|Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
2700523|NCT01241591|Secondary|Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study medication."|Week 12|FAS; OC|||percentage of participants|||Number
2700524|NCT01241591|Secondary|Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study medication."|Week 12|FAS; OC|||percentage of participants|||Number
2700525|NCT01241591|Secondary|Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
2700526|NCT01241591|Secondary|Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline and Weeks 2, 4, and 8|FAS; OC|||percentage of participants|||Number
2700527|NCT01241591|Secondary|Mean Change From Baseline in SF-36 Domain Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Week 12|FAS; OC|||score on a scale||Standard Error|Mean
2700528|NCT01241591|Secondary|Mean Change From Baseline in SF-36 MCS and PCS Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Week 12|FAS; OC|||score on a scale||Standard Error|Mean
2700529|NCT01241591|Secondary|Mean SF-36 Domain Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
2700530|NCT01241591|Secondary|Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
2700531|NCT01241591|Secondary|Median Time to DLQI Response|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. DLQI Response was defined as a 5-point reduction in the total DLQI score.|Weeks 4 and 12|Data were not analyzed as the endpoint of proportion of participants achieving a 5-point reduction from baseline in DLQI provided similar information.||||||
2700532|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC|||percentage of participants|||Number
2700533|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC|||percentage of participants|||Number
2700534|NCT01241591|Secondary|Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC|||scores on a scale||Standard Error|Mean
2700535|NCT01241591|Secondary|Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4 and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700536|NCT01241591|Secondary|Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700537|NCT01241591|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4 and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700538|NCT01241591|Secondary|Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
2700539|NCT01241591|Secondary|Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700540|NCT01241591|Secondary|Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700541|NCT01241591|Secondary|Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment||Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
2700542|NCT01241591|Secondary|Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC|||weeks||95% Confidence Interval|Median
2700543|NCT01241591|Secondary|Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
2700544|NCT01241591|Secondary|Median Time to PASI50 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC|||weeks||95% Confidence Interval|Median
2700545|NCT01241591|Secondary|Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participatns|||Number
2700546|NCT01241591|Secondary|Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||percent change from baseline||Standard Error|Mean
2700547|NCT01241591|Secondary|Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||percent psoriatic BSA||Standard Error|Mean
2700548|NCT01241591|Secondary|Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||scores on a scale||Standard Error|Mean
2700549|NCT01241591|Secondary|Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700550|NCT01241591|Secondary|Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||scores on a scale||Standard Error|Mean
2700551|NCT01241591|Secondary|Mean PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
2700552|NCT01241591|Secondary|Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.|Weeks 2, 4, and 8|FAS; OC|||percentage of participants|||Number
2700553|NCT01241591|Secondary|Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
2700554|NCT01241591|Secondary|"Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response is defined as 0 (clear) or 1 (almost clear).|Weeks 2, 4, and 8|FAS; Observed Case (OC): no imputation|||percentage of participants|||Number
2702301|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported for pre-discharge visit|pre-discharge|75 CRT-D patients had data available at pre-discharge|||Ohms||Standard Deviation|Mean
2700555|NCT01241591|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.|Week 12|FAS; NRI|||percentage of participants|||Number
2700556|NCT01241591|Primary|"Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 12|Full Analysis Set (FAS): all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550, etanercept, or placebo); Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.|||percentage of participants|||Number
2700557|NCT01241565|Secondary|Incidence of Serosal Tearing||Day 30||||participants||95% Confidence Interval|Number
2700558|NCT01241565|Secondary|Duration of Chest Tube Following Surgery|Chest tube duration was calculated as removal date - placement date + 1|Approximately Day 5||||days||Standard Deviation|Mean
2700559|NCT01241565|Secondary|Length of Hospital Stay||Approximately Day 6||||days||Standard Deviation|Mean
2700560|NCT01241565|Secondary|Duration of Air Leak|Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.|Day 30||||days||Standard Deviation|Mean
2700561|NCT01241565|Secondary|Incidence of Air Leaks|As recorded on the air leak log.|Day 30||||number of patients with air leaks|||Number
2700562|NCT01241565|Primary|Incidence of Prolonged Air Leaks|Defined as > 5 days by the Society for Thoracic Surgery|Day 30||||participants|||Number
2700563|NCT01241552|Secondary|Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|Up to 12 weeks|Participants with compromised immunity at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700564|NCT01241552|Secondary|Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with an epidemic strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700565|NCT01241552|Secondary|Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with the B1/NAP1/027 strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700566|NCT01241552|Secondary|Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2)body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|Up to 12 weeks|Participants with clinically severe CDI at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700567|NCT01241552|Secondary|Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with a history of CDI in the 6 months prior to enrollment who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2702302|NCT01227785|Primary|Clinical Performance at Implant LV Pacing Impedance for CRT-D.|LV pacing impedance results at implant were measured in CRT-D.|implant|78 CRT-D patients had data available at implant|||Ohms||Standard Deviation|Mean
2700568|NCT01241552|Secondary|Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants ≥ 65 years of age at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700569|NCT01241552|Primary|Percentage of Participants With Infusion-specific AEs|Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.|Up to 24 hours|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
2700570|NCT01241552|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
2700571|NCT01241552|Primary|Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
2700572|NCT01241552|Primary|Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
2700573|NCT01241552|Primary|Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
2700574|NCT01241552|Primary|Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
2700590|NCT01241461|Secondary|Number of Participants With Tumor Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions.|Baseline to study completion up to Day 183|All participants who were enrolled in the study.|||Participants|||Count of Participants
2700830|NCT01239121|Secondary|Medication-related Symptoms|Patient's self-report of medication-related symptoms by telephone questionnaire|Up to 1 month after hospital discharge|"For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.~Outcome not ascertained in the third arm because those participants were not hospitalized."|||participants|||Number
2700575|NCT01241552|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; complied with Good Clinical Practice; and achieved clinical cure of the initial CDI episode.|||Percentage of participants|||Number
2700576|NCT01241552|Secondary|Percentage of Participants With Global Cure|Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700577|NCT01241552|Primary|Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
2700578|NCT01241539|Secondary|Additional Safety Parameters|By study design abnormalities could be due to dialysis or Dabigatran.|2 periods of 5 days each|TS|||Participants|||Number
2700579|NCT01241539|Secondary|Safety and Tolerability|Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.|2 periods of 5 days each|TS|||Participants|||Number
2700580|NCT01241539|Secondary|Coagulation Parameters|Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.|Day 3|TS|||sec||Standard Deviation|Mean
2700581|NCT01241539|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.|Day 3|PKS|||h||Geometric Coefficient of Variation|Geometric Mean
2700582|NCT01241539|Secondary|Maximum Plasma Concentrations of Dabigatran (Cmax)|Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.|Days 2 and 3|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2700583|NCT01241539|Secondary|Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)|Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.|Days 2 and 3|Pharmacokinetic set (PKS) includes all evaluable patients of the TS who received at least 1 dose of dabigatran etexilate, who provided at least 1 observation for at least 1 Pharmacokinetics (PK) endpoint, and who did not have important protocol violations relevant to the evaluation of PK|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2700584|NCT01241539|Primary|Plasma Concentration Extraction Ratio|Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).|4 hours|PKS|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2700585|NCT01241539|Primary|Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis|Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.|4 hours|PKS|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2700586|NCT01241539|Primary|Dialysis Clearance of Dabigatran|Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.|4 hours|Pharmacokinetic set (PKS) includes all evaluable patients of the treated set who received at least one dose of dabigatran etexilate and who provide at least one observation for at least one Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2700587|NCT01241513|Primary|Arterial Oxygen Saturation|Finger Pulse Oximetry to measure arterial oxygen saturation|Day 4 of treatment during acute altitude exposure||||percentage of oxygen saturation||Standard Deviation|Mean
2700588|NCT01241461|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702||Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose|All participants who were enrolled in the study.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2700589|NCT01241461|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702|AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state.|Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose|All participants who were enrolled in the study.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2700616|NCT01241318|Primary|All-cause Neonatal Mortality|All-cause neonatal mortality based on vital status at 28 days post-partum|28 days post-partum||||participants|||Number
2700591|NCT01241461|Primary|Number of Participants With Clinically Significant Effects|A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.|Baseline through 30 days|All participants who were enrolled in the study.|||Participants|||Count of Participants
2700592|NCT01241448|Secondary|The 30-Day Adjusted Rate of Hypoglycemic Episodes|A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)]. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Outcome measure was not analyzed due to the limited number of hypoglycemic events observed.|Baseline through 24 weeks|Outcome measure was not analyzed due to the limited number of hypoglycemic events observed; therefore zero participants were analyzed.||||||
2700593|NCT01241448|Secondary|The Percentage of Participants Experiencing a Hypoglycemic Episode|A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)].|Baseline through 24 weeks|All randomized participants who received at least 1 dose of study drug (excluding participant data from the excluded site).|||percentage of participants|||Number
2700594|NCT01241448|Secondary|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021|Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Baseline up to 26 weeks|All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2700595|NCT01241448|Secondary|Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021|Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Baseline up to 26 weeks|All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2700596|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Weight|Least squares means were adjusted for baseline weight, metformin use, visit, treatment and visit by treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline weight measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
2700597|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B|HOMA-B is a computer model (based on HOMA-2) that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Higher values indicate greater beta cell function. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 week|All randomized patients with at least 1 post-baseline HOMA-B measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||percent of normal reference population||95% Confidence Interval|Least Squares Mean
2700598|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is a computer model (based on HOMA2) which uses fasting plasma insulin and glucose concentrations to estimate insulin resistance (HOMA-IR) as a proportion reference population (normal young adults). The normal reference population with normal function was indexed to 1.0. Higher values indicate increased insulin resistance. Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline HOMA-IR measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||proportion of normal reference populatio||95% Confidence Interval|Least Squares Mean
2700599|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Free Fatty Acids|Least squares mean use an analysis of covariance model. The model included baseline free fatty acid, metformin use and treatment.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline free fatty acid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
2700600|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)|Subfraction included: Very Low Density Lipoprotein (VLDL) Total. Least squares mean use an analysis of covariance model. The model included baseline lipoprotein subfractions, metformin use and treatment.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline lipoprotein subfractions measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized, last observation carried forward (LOCF) principle was applied.|||nanomoles per liter (nmol/L)||Standard Error|Least Squares Mean
2700660|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||percentage of participants|||Number
2725218|NCT01059682|Primary|Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound||24 months||||mm/year||Standard Deviation|Mean
2700601|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile|Fasting Lipid Profile included: Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline fasting lipid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2700602|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total|GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. Total GLP-1 is the active GLP-1 and the Dipeptidyl Peptidase IV cleaved GLP-1 form. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline GLP-1 active and total measurements (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||picomoles per liter (pmol/L)||95% Confidence Interval|Least Squares Mean
2700603|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Insulin|Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline fasting insulin measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||picomoles per liter (pmol/L)||95% Confidence Interval|Least Squares Mean
2700604|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Plasma Glucose|Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline plasma glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2700605|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile|SMBG profiles consisted of blood glucose values collected before and 2 hours after the 3 main meals and at 0300 hours (3:00 AM). Values represent mean of values collected same time on 3 separate days within a week prior to visit. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline self-monitored glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2700606|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)|Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All participants randomly assigned to treatment with at least 1 post-baseline laboratory FBG measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomly assigned.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2700607|NCT01241448|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)|Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All participants randomly assigned to treatment with at least 1 post-baseline HbA1c measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the participants were randomly assigned.|||percentage of Hemoglobin A1c (HbA1c)||90% Confidence Interval|Least Squares Mean
2700608|NCT01241435|Primary|Pharmacokinetics: Time to Maximum Concentration (Tmax)||Up to 72 hours after administration of study drug|Participants who received at least one dose of study drug.|||hours||Full Range|Median
2700609|NCT01241435|Primary|Pharmacokinetics: Maximum Concentration (Cmax)||Up to 72 hours after administration of study drug|Participants who received at least one dose of study drug.|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2700610|NCT01241435|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC)|The area under the plasma concentration versus time curve from 0 hours to infinity (AUC [0-∞]) for LY2216684 is presented.|Up to 72 hours after administration of study drug|Participants who received at least one dose of study drug.|||hours times nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2700611|NCT01241318|Secondary|Health Facility Characteristics|Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).|12 months after study initiation|Health facilities|||Health facilities|Health facilities||Number
2700612|NCT01241318|Secondary|Factors Influencing Delivery Location|Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)|28 days postpartum||2019-12-31|12/2019||||
2700613|NCT01241318|Secondary|Place of Delivery|The location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.|28 days postpartum||2019-12-31|12/2019||||
2700614|NCT01241318|Secondary|Incidence of Omphalitis|"Omphalitis, or umbilical cord infection, defined as:~presence of umbilical cord pus and mild, moderate or severe redness~moderate or severe redness without the presence of umbilical cord pus"|28 days postpartum||||neonates|||Number
2700615|NCT01241318|Primary|All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life|All-cause mortality by day 28 of life among newborns who survive at least the first day of life|28 days post-partum|All liveborn neonates who survived the first 24 hours after delivery|||neonates who survived first 24 hours|||Number
2700617|NCT01241292|Secondary|Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants|The detection of anti-elotuzumab anti-drug antibodies (ADAs) in human serum was performed using a validated bridging electrochemiluminescence immunoassay (ECLA) on the Meso Scale Discovery (MSD) platform. Sample collection was performed prior to administration of elotuzumab at Day 1 of each cycle.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
2700618|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 - 155; Gr 3: >155 - 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN - 130; Gr 3: <130 - 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN - 5.5; Gr 2: >5.5 - 6.0; Gr 3: > 6.0 - 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: <LLN - 3.0; Gr 3: < 3.0 - 2.5; Gr 4: <2.5 mmol/L.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
2700619|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 - 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
2700620|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes (absolute) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils (absolute): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
2700621|NCT01241292|Secondary|Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmin was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate PK concentration profiles were summarized.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2700622|NCT01241292|Secondary|Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2700623|NCT01241292|Secondary|Number of Participants With Best Overall Response - Treated Participants|Complete response (CR) and Partial Response (PR) were based on the European Group for Blood and Bone Marrow Transplant (EBMT) Criteria. Very Good Partial response was derived from the International Myeloma Working Group (IMWG) criteria. Participants who had a reduction in M-protein or plasmacytoma but did not meet the EBMT criteria for PR were classified as minimal response (MR). Hematologic, radiologic and/or clinical assessments were done every cycle starting with cycle 2. Each cycle is 4 weeks in length (Day 1, Day 8, Day 15, Day 22). Cycle 2 began on study Day 29. CR=negative immunofixation 6 weeks, <5% plasma cells, no increase in size or number of lytic lesions, complete disappearance of extramedullary plasmacytoma. PR=≥50%reduction in M-protein for 6 weeks, ≥90% reduction of urinary light chain excretion or < 200 mg/24hours for 6 weeks, ≥50% reduction in size of extramedullary plasmacytoma present at baseline, no increase in size or number of lytic lesions.|Cycle 2 (Study Day 29) to last dose (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized (Treated Participants).|||participants|||Number
2700624|NCT01241292|Primary|Number of Participants With Clinically Relevant Vital Sign Findings|Vital signs (body temperature, seated blood pressure, heart rate, and respiration rate) were recorded at screening on Days 1, 8, 15, and 22 of Cycles 1 and 2, on Days 1 and 15 of Cycle 3, and at the end of treatment. Blood pressure (Diastolic and Systolic) and heart rate were recorded after the participant sat quietly for at least 5 minutes. Clinical relevance of vital sign data was determined by the investigator.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
2700661|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:~- Transvalvular Mean Gradient"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||mmHg||Standard Deviation|Mean
2700625|NCT01241292|Primary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized (Treated Participants).|||participants|||Number
2700626|NCT01241279|Secondary|Visual Acuity|Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.|All visits through visit 4 (day 160-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.||||||
2700627|NCT01241279|Primary|Amplitude of Accommodation|The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.|Visit 4 (postoperative day 120-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.||||||
2700628|NCT01241240|Secondary|Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.|Weeks 1, 2, 4, 8 and 12|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
2700629|NCT01241240|Secondary|Change From Baseline in Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.|Baseline, Weeks 1, 2, 4 and 8|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
2700630|NCT01241240|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
2700631|NCT01240915|Secondary|Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16|Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding [RB]), if any.|Baseline and Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
2700632|NCT01240915|Secondary|Change From Baseline in Biopsy Histology Scores at Week 8|A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
2700633|NCT01240915|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
2700634|NCT01240915|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment [PGA]), each graded from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
2700635|NCT01240915|Secondary|Percentage of Participants in Clinical Response at Week 8|Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
2700636|NCT01240915|Secondary|Percentage of Participants With Endoscopic Response at Week 8|Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
2700637|NCT01240915|Secondary|Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
2700638|NCT01240915|Secondary|Percentage of Participants in Clinical Remission at Week 8|Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
2700639|NCT01240915|Secondary|Percentage of Participants in Endoscopic Remission at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
2700640|NCT01240915|Secondary|Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).|Week 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
2700641|NCT01240915|Secondary|Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16|CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||fold change||Geometric Coefficient of Variation|Geometric Mean
2700642|NCT01240915|Secondary|Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16|Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||fold change||Geometric Coefficient of Variation|Geometric Mean
2700643|NCT01240915|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP <90 millimeters of mercury (mm Hg) and >=30 mm Hg increase/decrease from baseline, DBP <50 mm Hg and >=20 mm Hg increase/decrease from baseline, pulse rate <40 or >120 beats per minute (bpm),|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
2700644|NCT01240915|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.|Baseline up to Week 24|The safety analysis population consisted of all participants who received at least 1 dose of study medication; n=the number of participants analyzed at that time point in the respective arms.|||participants|||Number
2726278|NCT01050673|Secondary|Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure||28 days|Pre and post-excision values added, (cfu/g) tissue.|||cfu/g||Standard Deviation|Median
2700645|NCT01240915|Secondary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 12, Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
2700646|NCT01240915|Primary|Number of Treatment-Emergent AEs by Severity|The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||adverse events|||Number
2700647|NCT01240915|Primary|Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)||Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
2700648|NCT01240915|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
2700649|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||scores on a scale||Standard Deviation|Mean
2700650|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 4|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
2700651|NCT01240915|Primary|Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint. Baseline observation carried forward (BOCF) was used for treatment failures.|||scores on a scale||Standard Deviation|Mean
2700652|NCT01240902|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:~Peak velocity >4 m/s~Mean gradient >35 mmHg~EOA < 0.8 cm2~TVIV1 / TVIV2 < 0.25"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||percentage of participants|||Number
2700653|NCT01240902|Secondary|Procedural Success|"Medtronic CoreValve® System subjects only.~Defined as device success and absence of in-hospital MACCE."|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.|||percentage of participants|||Number
2700654|NCT01240902|Secondary|Device Success|"Medtronic CoreValve® System subjects only.~Defined as:~Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,~Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),~Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)~Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.|||percentage of participants|||Number
2700655|NCT01240902|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population= Consisted of all subjects with an attempted implant procedure.|||days||Standard Deviation|Mean
2700656|NCT01240902|Secondary|Index Procedure Related MAEs||Procedure|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants|||Number
2700657|NCT01240902|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700658|NCT01240902|Secondary|Cardiovascular Deaths and Valve Related Deaths||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700659|NCT01240902|Secondary|Aortic Valve Hospitalizations||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure|||percentage of participants, Kaplan-Meier|||Number
2700663|NCT01240902|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||units on a scale||Standard Deviation|Mean
2700664|NCT01240902|Secondary|Ratio of Days Alive Out of Hospital Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||ratio of days alive and out of hospital||Standard Deviation|Mean
2700665|NCT01240902|Secondary|Change in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|30 day, 1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||meters||Standard Deviation|Mean
2700666|NCT01240902|Secondary|Change in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.~New York Heart Association (NYHA) Classification:~Class I: Subjects with cardiac disease but without resulting limitations of physical activity.~Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||average classification level change||Standard Deviation|Mean
2700667|NCT01240902|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700668|NCT01240902|Secondary|Major Adverse Events (MAEs)|"MAEs Include:~MACCE~Acute Kidney Injury~Cardiac Tamponade~Prosthetic Valve Dysfunction~Cardiogenic Shock~Valve Endocarditis~Life-Threatening, Disabling or Major Bleeding~Major Vascular Complication~Cardiac Perforation~Device Migration/Valve Embolism"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700669|NCT01240902|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:~All Cause Mortality~MI~All stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700670|NCT01240902|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~All Cause Mortality~Myocardial infarction (MI)~All Stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700671|NCT01240902|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2700672|NCT01240863|Secondary|Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters|A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).|Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment period|FAS of participants contributing baseline and endpoint data.|||msec||Standard Deviation|Mean
2700673|NCT01240863|Secondary|Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods|"The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.~The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination."|Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700674|NCT01240863|Secondary|Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods|"The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen).~The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination."|Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700675|NCT01240863|Secondary|Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period|"The COWS was a clinician rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5.~A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows:~0 to 4=normal~5 to 12=mild~13 to 24=moderate~25 to 36=moderately severe~>36=severe"|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700676|NCT01240863|Secondary|Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period|The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.|Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700677|NCT01240863|Secondary|Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Uric acid: M>=625, F>=506 μmol/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 %~Urinalysis: blood (hemoglobin) and total protein: >=2 unit increase from baseline"|Day 1 up to Day 128 in Double-Blind Treatment period|Full analysis set including participants with laboratory assessments|||Participants|||Count of Participants
2700678|NCT01240863|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 up to Day 128 in Double-Blind Treatment period|FAS|||Participants|||Count of Participants
2700679|NCT01240863|Secondary|Participants With Adverse Events|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period|Safety analysis set (Open-Label Titration) and FAS (Double-Blind Treatment)|||Participants|||Count of Participants
2700680|NCT01240863|Secondary|Brief Pain Inventory - Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period|For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 [does not interfere] to 10 [completely interferes]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration.|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700681|NCT01240863|Secondary|Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700722|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.|||Titers||95% Confidence Interval|Geometric Mean
2700682|NCT01240863|Secondary|Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period|"The CGI-S is a clinician-rated scale that assesses the severity of the patient's pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories:~1 normal-shows no sign of illness,~2 borderline ill,~3 mildly (slightly) ill,~4 moderately ill,~5 markedly ill,~6 severely ill, and~7 among the most extremely ill (Guy 1976).~The clinician assesses the severity of the patient's condition, based on the clinician's total clinical experience with patients with this condition, in response to treatment.~Endpoint values are the last observed postbaseline data."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700683|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Endpoint|"The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life~Endpoint values are the last observed postbaseline data."|Endpoint of the Double-blind Treatment Period (up to week 12)|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
2700684|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 12|"The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life"|Week 12 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
2700685|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 8|"The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life"|Week 8 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
2700686|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 4|"The PAF is a self-administered questionnaire used to measure patients' assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life"|Week 4 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
2700687|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Endpoint|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.~Endpoint values are the last observed postbaseline data."|Endpoint of the Double-blind Treatment Period (up to week 12)|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
2700688|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 12|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 12 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
2700689|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 8|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 8 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
2700690|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 4|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 4 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
2700691|NCT01240863|Secondary|Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period|"The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2726279|NCT01050673|Secondary|Cost of Reference Wound-related Surgical Procedures to Achieve Closure||28 days||||Dollars ($)||Standard Deviation|Mean
2700692|NCT01240863|Secondary|Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
2700693|NCT01240863|Secondary|Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
2700694|NCT01240863|Secondary|Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
2700695|NCT01240863|Secondary|Kaplan-Meier Estimates for Time to Discontinuation From the Study|Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment.|Day 1 to Week 12 of the double-blind treatment period|Full analysis set|||days||Inter-Quartile Range|Median
2700696|NCT01240863|Secondary|Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason|Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.|Day 1 to Week 12 of the double-blind treatment period|Full analysis set|||percentage of participants|||Number
2700697|NCT01240863|Primary|Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)|"The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.~The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity."|Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period|Full analysis set (FAS). One placebo patient was withdrawn from the study prior to receiving drug in the Double-blind Treatment period and is not included in the FAS. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.|||units on a scale||Standard Error|Least Squares Mean
2700698|NCT01240811|Secondary|Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis|Changes in vaginal flora as assessed by qPCR quantitation of H2O2 producing Lactobacilli species and Gardnerella vaginalis. Quantitative PCR (qPCR) results are reported as log concentration of gene copies/swab specimen.|2 Months||||log gene copies/swab||Full Range|Median
2700699|NCT01240811|Secondary|Change in Vaginal Flora|Changes in vaginal flora as assessed by Nugent score The Nugent score is calculated by microscopically assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with bacterial vaginosis, 4-6 is consistent with intermediate vaginal flora, and 0-3 is normal vaginal flora.|2 Months||||units on a scale||Full Range|Median
2700700|NCT01240811|Primary|%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium|Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety|2 months|All 40 participants who completed the study were included in the analysis. There were no lost-to-follow up participants. One participant withdrew and one participant was excluded post-enrollment. Both of these participants were replaced to fill our goal enrollment of 40 participants in the study.|||% of T-cells expressing CCR5||Standard Deviation|Mean
2700701|NCT01240785|Secondary|Child Outcome at 2 Years Per Arm|neuropsychological and motor skills testing|2 years after birth|||||||
2700714|NCT01240746|Other Pre-specified|Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to <9 years with available data for the relevant endpoint.|||Participants|||Number
2700715|NCT01240746|Other Pre-specified|Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.|"Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.~Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable.~Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to <36 months with available data for the relevant endpoint.|||Participants|||Number
2700716|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post-vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.|||Titers||95% Confidence Interval|Geometric Mean
2700717|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
2700718|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
2700719|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.|||Participants|||Number
2700720|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.|||Participants|||Number
2700721|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.|||Participants|||Number
2700735|NCT01240551|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|date treatment consent signed to date off study, approximately 52.5 months||||Participants|||Count of Participants
2726280|NCT01050673|Secondary|Cost Per Operative Procedure||28 days||||Dollars $||Standard Deviation|Mean
2700723|NCT01240746|Other Pre-specified|Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
2700724|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)"|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
2700725|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.|||Titers||95% Confidence Interval|Geometric Mean
2700726|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.|||Titers||95% Confidence Interval|Geometric Mean
2700727|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination"|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
2700728|NCT01240746|Primary|Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.|||Titers||95% Confidence Interval|Geometric Mean
2700729|NCT01240590|Secondary|Tumor Growth Rate Constant|Difference in time (days) required for the treated tumors to reach a predetermined target size.|21 days|This outcome measure was not analyzed because few if any re-assessments were done, thus there was not enough data to assess the growth rate constant on the patients.||||||
2700730|NCT01240590|Secondary|Number of Participants Who Underwent Medically-Necessary Interventions|Enrolled participants who had surgical procedures deemed medically necessary for their clinical care.|4.5 years||||Participants|||Count of Participants
2700731|NCT01240590|Primary|Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)|Here is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module.|4 years, 6 months and 26 days||||participants|||Number
2700732|NCT01240590|Primary|Progression Free Survival (Phase II)|Progression free survival (PFS) is defined as the duration of time from start of study treatment to time of progression. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 weeks|The outcome was not met because the patients died and were not scanned before their death.||||||
2700733|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks||||mg/m^2|||Number
2700734|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks||||mg/m^2|||Number
2700736|NCT01240551|Primary|Number of Participants With Present or Not Present Bone Metastasis|Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.|Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.|Patient with known prostate cancer. One group with known metastatic bone disease, based on prior clinical imaging scan (Tc-99m bone scan or NaF-18 bone scan or CT, and a second group with clinical risk factors for obtaining bony metastatic disease (i.e. pelvic soft tissue mets, high PSA (prostate specific antigen) blood levels).|||Participants|||Count of Participants
2700737|NCT01240382|Primary|Mean Change in Rose Bengal Staining Score From Baseline|"Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.~The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.|||points||Standard Deviation|Mean
2700738|NCT01240382|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.~The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.|||points||Standard Deviation|Mean
2700739|NCT01240356|Primary|Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination|The neurological examinations comprised assessments of mental status and orientation, cranial nerve examination, muscle strength and tone, deep tendon reflexes, sensory testing, coordination, and gait.|2-3 hours after treatment||||participants|||Number
2700740|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)|A modified Rankin Scale (mRS) score of 0 or 1 indicates an excellent outcome. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS scale ranks patients from 0 to 6 (0 is the best score, 6 is the worst score).|at 3-months from enrollment|ITT with modified Ranking scores (mSR) at 90 days. % displayed is % with excellent outcome (mRS of 0-1).|||percentage of patients||95% Confidence Interval|Number
2700741|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale|The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. Each item on the NIHSS scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|within 90 days of enrollment||||percentage of patients||95% Confidence Interval|Number
2700742|NCT01240356|Secondary|Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems|Ischemic stroke patients: 2-hour rates of arterial complete and partial recanalization as measured using standard Transcranial Doppler Ultrasound systems.|2-3 hours after treatment|ITT - Percent of patients who had complete recanalization after treatment.|||percentage of patients||95% Confidence Interval|Number
2700743|NCT01240356|Secondary|Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD|Phase I - A group of healthy volunteers will be assessed to determine the feasibility and activity of hands-free (HF) transcranial Doppler (TCD). Adverse events include subject complaints regarding discomfort of the device and dermatological adverse events as evidenced by a detailed physical examination of skin integrity post-insonation.|2-3 hours after treatment|ITT|||participants|||Number
2700744|NCT01240356|Primary|Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage|Phase II: Determine if the Hands-Free TCD will not result in higher than 10% rate of symptomatic intracerebral hemorrhage (ICH) within 24 hours (defined as clinical worsening > 4 NIH Stroke Scale (NIHSS) points and presence of hemorrhage on CT scan that in the opinion of the treating physician is causatively related to ICH on CT) in 0-3 hours acute stroke patients treated with intravenous tissue-type plasminogen activator (IV-t-PA).|within 24 hours|Intention to Treat (ITT)|||percentage of patients||95% Confidence Interval|Number
2700745|NCT01240356|Primary|Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain|Phase I : Imaging of the brain via MRI scans was performed to determine if the Hands-Free transcranial Doppler (TCD) system results in any BBB-disruption or deterioration in permeability.|2-3 hours after treatment||||participants|||Number
2700746|NCT01240330|Secondary|Subject Comfort|Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.|10 min therapy||||Units on a Scale||Standard Deviation|Mean
2700747|NCT01240330|Secondary|PFV Percent Augmentation|Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.|3 measurements/10 minute therapy||||percentages||Standard Deviation|Mean
2700803|NCT01239381|Secondary|2-year Local Control Rate|The percentage of participants with local control 2 years after the start of study treatment.|2 years||||percentage of participants||95% Confidence Interval|Number
2700748|NCT01240330|Primary|Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline|The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.|3 measurements/10 min. therapy||||cm/s||95% Confidence Interval|Mean
2700749|NCT01240304|Primary|Margin-negative Resection Rate|This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.|An average of 6 years|Early termination. No subject completed study. No data collected. No data analysis was completed.||||||
2700750|NCT01240200|Secondary|Number of Hypoglycemic Events|The number of hypoglycemic events occurring during the 24-week study period is reported here. For the purposes of this study, hypoglycemia is defined as a capillary and/or laboratory blood glucose value of less than 70 mg/dL.|Week 24|All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2).|||hypoglycemic events|||Number
2700751|NCT01240200|Secondary|Percent of Participants With Dosing Errors|Percentage of participants who had dosing errors during the course of the study (both study periods). Participants were instructed on using each device and practiced preparing and injecting the insulin dose into a pillow to assess accuracy with each method of delivering insulin. Dosing errors were defined as inaccurate preparation or injection by less than or equal to 10% of the intended dose, independent of vision and dexterity function.|Week 24|All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2).|||percentage of participants|||Number
2700752|NCT01240200|Secondary|Fasting Blood Glucose|Blood sugar levels are influenced by the size and types of food consumed during the last meal and the production and response to insulin. Fasting blood glucose levels of less than 100 milligrams per deciliter (mg/dL) are considered normal. Values between 100 and 125 mg/dL indicate prediabetes and values of 126 mg/dL and higher indicate diabetes. Fasting blood glucose levels can lower depending on food consumed and medications.|Baseline, Week 12|Participants with fasting blood glucose measurements at baseline and week 12 are included in this analysis.|||mg/dL||Standard Deviation|Mean
2700753|NCT01240200|Secondary|Hemoglobin A1c (HbA1c)|Hemoglobin A1c (HbA1c) measures the average percentage of blood sugar over the past 2 to 3 months. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. HbA1c can reduce with management of diabetes through diet, exercise, and medication.|Baseline, Week 12|Participants with HbA1c measurements at baseline and week 12 are included in this analysis.|||percentage of Hemoglobin A1c||Standard Deviation|Mean
2700754|NCT01240200|Primary|Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score|Treatment satisfaction after crossover into the second treatment period was assessed using the Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc). The questionnaire contains eight items scored on a seven-point scale where -3 = much less satisfied now and 3 = much more satisfied now. The satisfaction score is obtained from summing responses to questions 1, and 4 through 8 (the remaining two items assess perceived blood sugar levels). The total score can range from -18 to 18. Higher scores indicate higher satisfaction with the new diabetes treatment, compared to prior treatment, while scores below 0 mean that satisfaction with the new delivery method of insulin in Period 2 is lower than satisfaction with the delivery method in Period 1.|Week 24|This analysis includes participants who completed the week 12 and week 24 assessments.|||units on a scale||Standard Deviation|Mean
2700755|NCT01240200|Primary|Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score|Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained from summing responses to questions 1, 4, 5, 6, 7, and 8 and the total score can range from 0 to 36. Higher scores indicate higher satisfaction with diabetes treatment.|Baseline, Week 12|This analysis includes participants who completed the baseline and week 12 assessments.|||units on a scale||Standard Deviation|Mean
2700756|NCT01240135|Secondary|Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score|The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.|||units on a scale||Standard Deviation|Mean
2700757|NCT01240135|Primary|Lens Fit|As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.|||percentage of acceptable fit|||Number
2700758|NCT01240122|Secondary|Overall Ocular Comfort|All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.|Day 4|All subjects who completed the study were included in the analysis per protocol.|||score on a scale||Standard Deviation|Mean
2700759|NCT01240122|Secondary|Subjective Solution Preference|All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.|Day 4|All subjects who completed the study were included in the analysis per protocol.|||Participants|||Count of Participants
2700804|NCT01239381|Secondary|Median Progression Free Survival|The median amount of time participants survived without cancer progression following the start of study treatment. Progression was assessed using RECIST v1.0. Progressive Disease (PD) is defined as at least a 20% increase in the Longest Diameter (LD) of the lesion, taken as the reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|1 years||||Months||95% Confidence Interval|Median
2700760|NCT01240122|Primary|Corneal Staining by Wear Time|All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.|1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4|Corneal Staining Severity at Scheduled Visits (Safety Population)|||participants|||Number
2700761|NCT01239992|Other Pre-specified|LDL-cholesterol|Percent change of LDL-cholesterol at 12 weeks compared to baseline|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
2700762|NCT01239992|Secondary|Fasting Triglycerides|Percent change of fasting triglycerides at 12 weeks compared to baseline|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
2700763|NCT01239992|Secondary|HDL Cholesterol|Percent change of HDL-cholesterol at 12 weeks compared to baseline.|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
2700764|NCT01239992|Primary|Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test|Percent change of incremental AUC at 12 weeks compared to baseline.|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
2700765|NCT01239797|Secondary|Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores|"Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 (No pain, No interference) to 10 (Pain as bad as you can imagine, Highest imaginable interference) numeric rating scale."|Baseline to Study Completion (up to 7 years)||2019-10-31|10/2019||||
2700766|NCT01239797|Secondary|Median Overall Survival (OS)|Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|Randomization to 427 deaths (approximately 7 years)||2019-10-31|10/2019||||
2700767|NCT01239797|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.|Randomization to end of treatment (approximately 2 years)|All participants randomized to any treatment group|||percentage of participants||95% Confidence Interval|Number
2700768|NCT01239797|Primary|Median Progression Free Survival (PFS)|Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.|Randomization until 326 events (approximately 2 years)|All participants randomized to any treatment group|||months||95% Confidence Interval|Median
2700769|NCT01239745|Secondary|Overall Survival|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to Month 36)|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2700770|NCT01239745|Secondary|Recurrence-free Survival|Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.|Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2700771|NCT01239745|Secondary|Time to Discontinuation||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2700772|NCT01239745|Secondary|Number of Participants With Reasons for Discontinuation From Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2700773|NCT01239745|Secondary|Percentage of Participants Who Discontinued the Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2700774|NCT01239745|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||participants|||Number
2700775|NCT01239745|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||participants|||Number
2700805|NCT01239381|Secondary|Median Overall Survival|The median overall survival (in months) of participants as measured from the start of treatment.|2 years||||Months||95% Confidence Interval|Median
2700776|NCT01239745|Primary|Number of Participants With Adverse Events (AEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||participants|||Number
2700777|NCT01239732|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).|3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee.||||||
2700778|NCT01239732|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.|First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years|ITT population|||months||95% Confidence Interval|Median
2700779|NCT01239732|Secondary|Duration of Objective Response (DOR)|DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population|||months||95% Confidence Interval|Median
2700780|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria|Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.|RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2700781|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria|CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).|3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2700782|NCT01239732|Secondary|Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2700783|NCT01239732|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|Intent to treat population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2700784|NCT01239732|Primary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)|Safety population|||percentage of participants|||Number
2700785|NCT01239680|Primary|Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).|Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .|Change from Baseline in Cytokine Levels at 24 hours|The number of participants who had an intervention and completed the study with all 3 required blood draws.||||||
2700786|NCT01239511|Secondary|Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.||6 weeks|||||||
2700787|NCT01239511|Secondary|Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits||6 weeks|||||||
2700788|NCT01239511|Secondary|Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits||6 weeks|||||||
2700789|NCT01239511|Secondary|Change in Consumption of Short-acting Nitrates From Baseline to All Visits||6 weeks|||||||
2700790|NCT01239511|Secondary|Changes in Angina Frequency in Subject's Diary From Baseline to All Visits||6 weeks|||||||
2700791|NCT01239511|Secondary|Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit||6 weeks|||||||
2700792|NCT01239511|Secondary|Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit||6 weeks|||||||
2700793|NCT01239511|Secondary|Change in Time to Onset of Angina From Baseline to the Final Visit||6 weeks|||||||
2700794|NCT01239511|Primary|Change in Total Exercise Time (Seconds)|the time difference of total exercise time from V2 to V5 compare to placebo|6 weeks after the first exercise tolerance testing is conducted|ITT (intend-to-treat) population will be used for analysis|||second||Standard Deviation|Least Squares Mean
2700795|NCT01239472|Secondary|Evaluation of Renal Function|Evaluation of renal function (serum creatinine) 90 days after transplant and 365 days after transplant.|90 days after transplant and 365 days after transplant||||mg/dL||Inter-Quartile Range|Median
2700796|NCT01239472|Primary|Cytokines Evaluation|Cd106(VCAM-1) , IP-10/CXCL10, MIG/CXCL9, MCP-1/CCL2, IL-1, RANTES, IL-8, IL12p70, TNF, IL-10, IL-6, IL-1, VEGF, FGF, CD54(ICAM-1) were analysed in urine 90 days after transplant (before randomization), and 365 days after transplant. Material were conserved at -80 Celsius, and analysed by ELISA at same time. Data was shown in MFI units|Urine and biopsy data are collected 90 days and 365 days after transplant.|"15 patients were enrolled in each group. However in tacrolimus group 5 patients didn’t want to be submitted to other biopsy and to collect urine 365 days after transplant. And in everolimus group 3 patients had adverse events and was switched back to tacrolimus."|||MFI||Inter-Quartile Range|Median
2700797|NCT01239394|Secondary|Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia|Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years||||Participants|||Count of Participants
2700798|NCT01239394|Secondary|Progression-free Survival (PFS)|Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse|12 months||||percentage of patients||95% Confidence Interval|Number
2700799|NCT01239394|Secondary|Overall Response Rate (ORR)|"Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).~Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT"|1-month post-treatment||||percentage of patients|||Number
2700800|NCT01239394|Primary|Efficacy: Complete Response Rate (CRR)|"Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).~Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5 cm in greatest diameter)"|1-month post-treatment||||percentage of patients|||Number
2700801|NCT01239381|Secondary|Median Survival Among Participants With Colorectal Cancer|The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.|2 years|The 35 participants with colorectal cancer as the primary cancer.|||Months||95% Confidence Interval|Median
2700802|NCT01239381|Secondary|1 Year Local Control Rate Among Participants With Colorectal Cancer|The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.|1 year|Participants with colorectal cancer|||percentage of participants|||Number
2700807|NCT01239381|Primary|Local Control Rate|"The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD).~(CR): Disappearance of entire lesion, with no additional evidence of disease.~(PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD.~(SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The 90 participants that started study treatment|||percentage of participants|||Number
2700808|NCT01239368|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to last date off study, 81 months and 6 days|For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.|||Participants|||Count of Participants
2700809|NCT01239368|Secondary|Immune Reconstitution in Recipients of Th1.(T Helper Cell) Rapa Cells.|Immune reconstitution in recipients of Th1.rapa cells was determined by flow cytometry.|Baseline, prior to chemotherapy, and 2 weeks, 1, 2, and 3 months after final T cell infusion|For the planned protocol cohort 7, no pts were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. # that could be manufactured due to limiting reagents for cell culture. Outcome measure not done; data not collected in real-time due to premature closure of study.||||||
2700810|NCT01239368|Primary|Number of Patients Who Developed a Partial Response (PR)+Complete Response (CR) in Cohort B at Any Time Point Post Therapy With PR/CR Being Maintained Until Study Completed|Patients whose tumors shrunk and were disease free after therapy in cohort B. Partial response and complete response were assessed by the Consensus of the International Myeloma Working Group criteria. Partial response is defined as 50% or greater reduction in serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200 mg per 24h), 50% or greater reduction in the size of soft tissue plasmacytomas, if present at baseline, no evidence of progressive or new bone lesions if radiographic studies were performed (X-rays not required in absence of clinical indication). Complete response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow and no evidence of progressive or new bone lesion if radiographic studies were performed. Progressive disease is increases of ≥25% in serum M-component/urine M-component, or size of bone lesions.|Study completion at 22 months||||Participants|||Count of Participants
2700811|NCT01239368|Primary|Number of Participants With Progression Free Survival in Cohort A Th1 (Type 1 T Helper Cells)/Tc1 (T Cytotoxic Cells, Type 1) Rapa Prevention of Relapse|Progressive disease is assessed by the Consensus of the International Myeloma Working Group criteria and is defined as one or more of the following: Increases of greater or equal to 25% in serum M-component (minimum absolute increase of 0.5 g/dl) or urine M-component (minimum absolute increase of 200mg/24h) or percentage of bone marrow plasma cells (minimum absolute percentage of 10%) or size of bone lesions or new plasmacytoma, or development of hypercalcemia solely attributable to the disease.|Study completion at 22 months|The PFS was only used in cohort A, which had just one patient.|||Participants|||Count of Participants
2700812|NCT01239368|Primary|Number of Patients With an Adverse Event Attributable to the Investigational Therapy|Participants were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|2 months|For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.|||Participants|||Count of Participants
2700813|NCT01239355|Secondary|Overall Survival|Survival will be estimated by the product-limit (Kaplan-Meier) estimator.|Until death, up to 26 months||||Months||95% Confidence Interval|Median
2700814|NCT01239355|Secondary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months||||participants|||Number
2700815|NCT01239355|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death, up to 26 months||||Months||95% Confidence Interval|Median
2700816|NCT01239342|Secondary|Time to Failure (TTF)|TTF defined as Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date.|Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date, assessed up to 5 years|No participants analyzed. Data not collected.||||||
2700817|NCT01239342|Secondary|Median Overall Survival (OS) in Months|Overall survival reported in months as time interval between the date of treatment and the date of death or last follow-up.|Time interval between the date of treatment and the date of death or last follow-up, assessed up to 5 years||||Months||Full Range|Median
2700831|NCT01239121|Secondary|Adverse Drug Events|Actual harm to patient from hospital medication discrepancies by record review|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.|||participants|||Number
2700818|NCT01239342|Secondary|Overall Response Rate (ORR) Defined as Complete Response (CR) + Partial Response (PR)|Response for CR + PR defined by RECIST version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.|Up to 5 years|One participant in each group left study before restaging therefore are excluded from response outcome analysis.|||percentage of participants|||Number
2700819|NCT01239342|Secondary|Summary of Selected Toxicities Grade 3 or Greater Toxicity Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Adverse Events (AEs) list of reported events with associated intervention agent in a uniform presentation of events. The method of Thall, Simon and Estey (1995, 1996) was used to collect study participants' safety data summarized by treatment arm, category, severity and relevance. Comprehensive listing of AEs collected on study can be found in Adverse Event section separated by severity, Serious and Other AEs and represented by treatment arm, organ system-category within defined severity.|Up to 5 years||||Toxicities|||Number
2700820|NCT01239342|Secondary|Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)|Clinical benefit defined as participants' with CR+PR+SD assessed using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.|Up to 5 years|One participant in each group left study before restaging therefore are excluded from outcome analysis.|||Participants|||Count of Participants
2700821|NCT01239342|Primary|Median Progression Free Survival (PFS) in Months|PFS defined as Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first. Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first, assessed up to 5 years|One participant in each group left study before restaging therefore are excluded from response outcome analysis.|||Months||95% Confidence Interval|Median
2700822|NCT01239316|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data|||penetration rate||Full Range|Median
2700823|NCT01239316|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patient with sustained objective response|||months|||Number
2700824|NCT01239316|Primary|Pharmacokinetics (Plasma) of GDC-0449|plasma GDC-0449 concentration of day 21 in first course|up to 12 month|Patients who have day 21 plasma GDC-0449 concentration data available|||uM||Full Range|Median
2700825|NCT01239316|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years||||months||95% Confidence Interval|Median
2700826|NCT01239316|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months||||participants|||Number
2700827|NCT01239212|Secondary|Number of Participants With Adverse Events|Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.|24 hours after dose|||||||
2700828|NCT01239212|Secondary|Change in Vital Sign Baseline|Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.|24 hours after loading dose|||||||
2700829|NCT01239212|Primary|Pharmacokinetic Profile|3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.|5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)|all participants had adequate levels drawn for analysis|||ml/min/kg||Full Range|Median
2702303|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Threshold|RA pacing threshold results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month visit|||volts (V)||Standard Deviation|Mean
2700832|NCT01239121|Primary|Transition Drug Risk|Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.|||units: risk-weighted discrepancies||Standard Deviation|Mean
2700833|NCT01239056|Secondary|Adverse Events||1 year||||participants|||Number
2700834|NCT01239056|Primary|Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen|"Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .~Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst."|baseline||||participants|||Number
2700835|NCT01239056|Secondary|Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).||6 to 12 weeks after baseline||||participants|||Number
2700836|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
2700837|NCT01239043|Other Pre-specified|Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
2700838|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2700839|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
2700840|NCT01239043|Other Pre-specified|Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
2700841|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2700842|NCT01239043|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.~Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF."|Day 0 to Day 7 post-vaccination|Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
2700843|NCT01238991|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.||||||
2700855|NCT01238900|Primary|Long-term Success Rate in Resolution of Biliary Strictures|Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.|at least 12 months after stent removal|Per-protocol analysis, the 18 participants available for long term success follow-up consisted of: 11 with CP, 3 with OLT, and 4 others. Intention to treat analysis of long-term success consisted of 22 overall patients, 12 CP patients, 3 OLT patients, and 7 other patients. This analysis included all patients lost to follow-up as long-term failures.|||participants|||Number
2726281|NCT01050673|Secondary|Time of Actual Excision Procedure||28 days||||Time (Minutes)||Standard Deviation|Median
2700844|NCT01238991|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.||||||
2700845|NCT01238991|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.||||||
2700846|NCT01238991|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.||||||
2700847|NCT01238991|Other Pre-specified|Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.||||||
2700848|NCT01238991|Other Pre-specified|Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.|||Units/mL||95% Confidence Interval|Geometric Mean
2700849|NCT01238991|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.|Baseline of the preceding studies through 24 months of this study|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.|||Participants|||Number
2700850|NCT01238991|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.||||||
2700851|NCT01238991|Primary|Number of Treatment Emergent Adverse Events (AEs) by Severity|Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.|||Events|||Number
2700852|NCT01238900|Secondary|Frequency and Severity of Adverse Events (Including Stent Migration)|Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria|up to 12 months|Stent migration was seen in 9/23 patients (5 downstream, 4 upstream). It was without clinical complications except in one case. Post-procedure pain experienced by 1 patient was effectively treated by downgrading the stent size to a smaller diameter.|||participants|||Number
2700853|NCT01238900|Secondary|Ease of Stent Removal|The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).|at time of procedure||||participants|||Number
2700854|NCT01238900|Secondary|Number of Endoscopic Treatments Per Patient|The average number of ERCPs performed per patient required for resolution of benign strictures.|At time of procedure||||endoscopic treatments||Full Range|Mean
2700874|NCT01238848|Primary|Hospitalization Days|hospitalization days|Participants will be followed for the duration of hospitalization, an expected average of 4 days||||days||Standard Deviation|Median
2700856|NCT01238900|Primary|Short Term Success Rate in the Resolution of Biliary Strictures|Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.|6 months|Of the 23 participants that entered the study, 22 saw short-term success. The population consisted of 14 Chronic pancreatitis patients, 4 postorthotopic liver transplant patients, and 5 others.|||participants|||Number
2700857|NCT01238861|Secondary|Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52|"Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||parts per billion||Standard Deviation|Mean
2700858|NCT01238861|Secondary|Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52|"Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percent nocturnal awakening-free nights||Standard Deviation|Mean
2700859|NCT01238861|Secondary|Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52|"The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2700860|NCT01238861|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52|"The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2700861|NCT01238861|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline >=0.5), no change (defined as change from baseline >= -0.5 to less than [<] 0.5), and worse (defined as change from baseline < -0.5). Data was summarized by each treatment group.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."|||units on a scale||Standard Deviation|Mean
2700862|NCT01238861|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) at Week 52|"The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters per minute||Standard Deviation|Mean
2700863|NCT01238861|Secondary|Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52|Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Deviation|Mean
2700864|NCT01238861|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|"FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Deviation|Mean
2700865|NCT01238861|Secondary|Change From Baseline in Rescue Medication Use at Week 51-52|Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."|||rescue medication per 2 weeks||Standard Deviation|Mean
2700866|NCT01238861|Secondary|Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52|"Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2700867|NCT01238861|Secondary|Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52|"Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms."|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2700868|NCT01238861|Secondary|Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2700869|NCT01238861|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants|Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study.|Baseline up to Week 92|The mITT population included all randomized participants who received any dose of investigational product.|||percentage of participants|||Number
2700870|NCT01238861|Secondary|Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.|||microgram per milliliter||Standard Deviation|Mean
2700871|NCT01238861|Secondary|Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.|||microgram per milliliter||Standard Deviation|Mean
2700872|NCT01238861|Secondary|Dose Response in EOS+ Participants||Baseline up to Week 66|Due to change in planned analysis after unblinding of study data, dose response was not performed.||||||
2700873|NCT01238861|Primary|Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants|The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.|Week 1 up to Week 52|The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.|||AER events/person-year|||Number
2700876|NCT01238822|Primary|Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items|"Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54~O - No ADHD symptoms 54 - Highest ADHD symptoms"|end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.|Intent to treat with imputation for missing data.|||Score||Standard Deviation|Mean
2700877|NCT01238640|Secondary|Product Dissolution Time|Product Dissolution Time is the time from administration until the investigational products were completely dissolved.|During 10 hours post-dose||||Minutes||Standard Deviation|Mean
2700878|NCT01238640|Primary|AUC(0-∞)|AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).|10 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
2700879|NCT01238640|Primary|Area Under the Curve [AUC(0-t)]|Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).|During 10 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
2700880|NCT01238640|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)|During 10 hours post-dose||||ng/mL||Standard Deviation|Mean
2700881|NCT01238588|Secondary|Hemodialysis Access Stenosis/Thrombosis||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).||||||
2700882|NCT01238588|Secondary|Rate of Cardiovascular Events||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).||||||
2700883|NCT01238588|Secondary|Hemoglobin Level||Baseline and 6 months|Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source)||||||
2700884|NCT01238588|Secondary|Erythropoiesis Stimulating Agent (ESA) Dose Requirement||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).||||||
2700885|NCT01238588|Secondary|Albumin Levels||Baseline and 6 months|Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source)||||||
2700886|NCT01238588|Primary|Changes in Interleukin-6 (IL-6) Level||Baseline and 6 months|Blood samples were collected but the measurements were not done due to early study termination (per funding source).||||||
2700887|NCT01238588|Primary|Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level||Baseline and 6 months|Blood samples were collected but the measurements were not done due to early study termination (per funding source).||||||
2700888|NCT01238588|Primary|Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score||Baseline and 6 months|Scans were done but not analyzed due to early study termination (per funding source).||||||
2700889|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700890|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700891|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700892|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700893|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700894|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700895|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45.|Baseline||||units on a scale||95% Confidence Interval|Mean
2700896|NCT01238575|Secondary|Aberrant Behavior Checklist Hyperactivity Subscale|"The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech.~The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48."|Baseline||||units on a scale||95% Confidence Interval|Mean
2700897|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2700898|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2700899|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2700900|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2700901|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2700902|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 - 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2700903|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 8||||units on a scale||95% Confidence Interval|Least Squares Mean
2702304|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Threshold|RA pacing threshold results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge|||volts (V)||Standard Deviation|Mean
2700904|NCT01238575|Primary|Aberrant Behavior Checklist Hyperactivity Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.|Week 8||||units on a scale||95% Confidence Interval|Least Squares Mean
2700905|NCT01238549|Other Pre-specified|SCI-QoL Grief Loss|Average score on SCI-QoL Grief Loss. The minimum score on the scale is 30.9 and the maximum is 76.1. A higher score represents more grief/loss (worse functioning). A lower score represents less grief/loss (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700906|NCT01238549|Secondary|SCI-QoL Trauma|Average score on SCI-QoL Trauma. The minimum score on the scale is 38.4 and the maximum is 85.2. A higher score represents more trauma (worse functioning). A lower score represents less trauma (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700907|NCT01238549|Secondary|SCI-QoL Stigma|Average score on SCI-QoL Stigma. The minimum score on the scale is 37.8 and the maximum is 77.3. A higher score represents more stigma (worse functioning). A lower score represents less stigma (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700908|NCT01238549|Secondary|SCI-QoL Satisfaction With Social Roles and Activities|Average score on SCI-QoL Satisfaction with Social Roles and Activities. The minimum score on the scale is 28.3 and the maximum is 60.5. A higher score represents more satisfaction with social roles and activities (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700909|NCT01238549|Secondary|SCI-QoL Resilience|Average score on SCI-QoL Resilience. The minimum score on the scale is 16.4 and the maximum is 66.4. A higher score represents more resilience (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700910|NCT01238549|Secondary|SCI-QoL Positive Affect and Well-being|Average score on SCI-QoL Positive Affect and Well-being. The minimum score on the scale is 26.7 and the maximum is 68.6. A higher score represents more positive affect and well-being (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700911|NCT01238549|Secondary|SCI-QoL Pain Interference|Average score on SCI-QoL Pain Interference. The minimum score on the scale is 40.2 and the maximum is 79.7. A higher score represents more pain interference (worse functioning). A lower score represents less anxiety (better functioning).|Baseline|One participant did not completed item bank or outcomes.|||units on a scale||Standard Deviation|Mean
2700912|NCT01238549|Secondary|SCI-QoL Pain Behavior|Average score on SCI-QoL Pain Behavior. The minimum score on the scale is 38.2 and the maximum is 76.1. A higher score represents more pain behavior (worse functioning). A lower score represents less pain behavior (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700913|NCT01238549|Secondary|SCI-QoL Depression|Average score on SCI-QoL Depression. The minimum score on the scale is 38.3 and the maximum is 81.9. A higher score represents more depression (worse functioning). A lower score represents less depression (better functioning).|Baseline|One participant did not completed item bank or outcomes.|||units on a scale||Standard Deviation|Mean
2700914|NCT01238549|Secondary|SCI-QoL Bladder Management Difficulties|Average score on SCI-QoL Bladder Management Difficulties. The minimum score on the scale is 39.7 and the maximum is 76.8. A higher score represents more bladder management difficulties (worse functioning). A lower score represents fewer bladder management difficulties (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700915|NCT01238549|Secondary|SCI-QoL Bowel Management Difficulties|Average score on SCI-QoL Bowel Management Difficulties. The minimum score on the scale is 39.2 and the maximum is 76.3. A higher score represents more bowel management difficulties (worse functioning). A lower score represents fewer bowel management difficulties (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700916|NCT01238549|Secondary|SCI-QoL Anxiety|Average score on SCI-QoL Anxiety. The minimum score on the scale is 36.3 and the maximum is 84.2. A higher score represents more anxiety (worse functioning). A lower score represents less anxiety (better functioning).|Baseline||||units on a scale||Standard Deviation|Mean
2700917|NCT01238549|Secondary|SCI-QoL Ability to Participate in Social Roles and Activities|Average score on a SCI-QoL Ability to Participate in Social Roles and Activities scale. The minimum score on the scale is 25.1 and the maximum is 61.1. A higher score represents better functioning (more ability to participate in social roles and activities).|Baseline|One participant did not completed item bank or outcomes.|||units on a scale||Standard Deviation|Mean
2700918|NCT01238549|Primary|SCI-QoL Independence|Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome.|Baseline|One participant did not completed item bank or outcomes.|||units on a scale||Standard Deviation|Mean
2700919|NCT01238536|Secondary|Leg Pain NRS|Leg Pain NRS 0-10 scale|12 months||||units on a scale||Standard Deviation|Mean
2700920|NCT01238536|Secondary|Roland Morris Disability Questionnaire (RDQ)|The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.|12 months||||units on a scale||Standard Deviation|Mean
2700921|NCT01238536|Secondary|Pain Numeric Rating Scale|Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week.|6 weeks||||units on a scale||Standard Deviation|Mean
2701381|NCT01235351|Primary|Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)|The outcome measurement was on-treatment PRI determined through flow cytometric assessment of phosphorylation status of VASP.|Approximately every 2 weeks for 8 weeks|Non-carriers did not receive clopidogrel 225 mg or 300 mg|||% of PRI||95% Confidence Interval|Mean
2700922|NCT01238536|Primary|Roland Morris|The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.|6 weeks|6 week follow up rate was 97% (n=193/200, n=193/200).|||units on a scale||Standard Deviation|Mean
2700923|NCT01238471|Secondary|Safety of Propranolol Therapy in Premature Infants|Close monitoring for possible side effects of propranolol in premature infants|4 weeks of propranolol therapy in premature infants|||||||
2700924|NCT01238471|Primary|Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy|"If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome.~Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina."|propranolol therapy for up 4 weeks||||cases|||Number
2700925|NCT01238341|Secondary|Total Procedure Time||During procedure, up to 3 hours||||minutes|Participants|Full Range|Mean
2700926|NCT01238341|Secondary|Successful Endoscopic Therapy||During procedure, up to 3 hours||||ERCPs|Participants||Number
2700927|NCT01238341|Secondary|Successful Cannulation of the Duct of Intent|Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.|During procedure, up to 3 hours||||ERCPs|Participants||Number
2700928|NCT01238341|Primary|Papilla or Duct-enterostomy Was Reached||During procedure, up to 3 hours||||ERCPs|Participants||Number
2700929|NCT01238211|Secondary|Overall Survival|Overall survival (OS) is defined as time from registration to death. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|||||||
2700930|NCT01238211|Secondary|Disease-free Survival|Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The median DFS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|||||||
2700931|NCT01238211|Secondary|Cumulative Incidence of Death||Up to 10 years|||||||
2700932|NCT01238211|Secondary|Cumulative Incidence of Relapse||Up to 10 years|||||||
2700933|NCT01238211|Secondary|Complete Response Rate|"Percentage of participants who achieve a CR.~CR is defined in the above outcome measure."|Up to 10 years|||||||
2700934|NCT01238211|Secondary|Event-free Survival|"Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,~Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts)."|Up to 10 years|||||||
2700935|NCT01238211|Primary|30 Day Survival Rate|Percentage of participants who were alive 30 days after starting induction treatment.|30 days||||percentage of participants||95% Confidence Interval|Number
2700936|NCT01238172|Secondary|Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall|At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables.|Up to 2 years|Participants with available data on the individual study measure at baseline and 24 months were included in the analysis|||servings per day||95% Confidence Interval|Mean
2700937|NCT01238172|Secondary|Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24|Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer [MAX-PC] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL|Up to 2 years|modified ITT population: Only participants with available data on the individual study measure at baseline and 24 months were included in the analysis.|||score on a scale||Full Range|Median
2700938|NCT01238172|Secondary|Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed|Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below.|Up to 2 years|The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.|||Participants|||Count of Participants
2700952|NCT01237821|Primary|Facial Lesion Counts: Papules|Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Papule Count||Full Range|Mean
2701382|NCT01235338|Secondary|Pulse Rate||Baseline and up to 39 days|SAS|||bpm||Standard Deviation|Mean
2700939|NCT01238172|Primary|Time to Progression|Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).|Up to 2 years|The primary analysis was based on the modified intention-to-treat (m-ITT) analysis population. The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.|||days||95% Confidence Interval|Median
2700940|NCT01237899|Secondary|Pharmacokinetics LY2623091: Area Under the Concentration-Time Curve (AUC) at Day 6|AUC from time 0, extrapolated to infinity, estimated for LY2623091.|Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose|All participants who received at least 1 dose of study drug and for whom the data are considered sufficient and interpretable.|||microgram*hour per milliliter (µg*h/mL)||Standard Deviation|Mean
2700941|NCT01237899|Secondary|Pharmacokinetics of LY2623091: Maximal Concentration (Cmax) at Day 6|Cmax estimated for LY2623091.|Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose|All participants who received at least 1 dose of study drug and for whom the data are considered sufficient and interpretable.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2700942|NCT01237899|Secondary|Pharmacodynamics: Serum to Urine Potassium Area Under the Concentration-Time Curve (AUC) Standardized for Urinary Excretion at Day 7|A measure of the renal clearance of the potassium ion (K+). The Least Squares (LS) Mean value was adjusted for pre-challenge renal K+ clearance.|Day 7: 24 Hour (hr), 48hr and 72hr Postdose|All participants who received at least 1 dose of study drug and for whom the data are considered sufficient and interpretable.|||liter per hour (L/h)||95% Confidence Interval|Least Squares Mean
2700943|NCT01237899|Primary|Number of Participants With Clinically Significant Effects (Adverse Events)|A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.|Baseline through 7 days for each treatment period|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2700944|NCT01237821|Primary|Subjective Tolerability of Irritation Assessment (Participant Assessed): Burning|Irritation burning was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700945|NCT01237821|Primary|Subjective Tolerability of Irritation Assessment (Participant Assessed): Itching|Irritation itching was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700946|NCT01237821|Primary|Subjective Tolerability of Irritation Assessment (Participant Assessed): Tingling|Irritation tingling was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700947|NCT01237821|Primary|Subjective Tolerability of Irritation Assessment (Participant Assessed): Stinging|Irritation stinging was subjectively reported by participants and captured on a 4 point ordinal scale (0= none; 1= mild; 2= moderate; 3= severe). Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700948|NCT01237821|Primary|Facial Lesion Counts: Total Lesion|Participants were assessed for all facial lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Total Lesion Count||Full Range|Mean
2700949|NCT01237821|Primary|Facial Lesion Counts: Inflammatory Lesions|Participants were assessed for facial inflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Inflammatory Lesion Count||Full Range|Mean
2700950|NCT01237821|Primary|Facial Lesion Counts: Noninflammatory Lesions|Participants were assessed for facial noninflammatory lesions and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Noninflammatory Lesion Count||Full Range|Mean
2700951|NCT01237821|Primary|Facial Lesion Counts: Pustules|Participants were assessed for facial pustules and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Pustules Count||Full Range|Mean
2700976|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700953|NCT01237821|Primary|Facial Lesion Counts: Closed Comedones|Participants were assessed for facial closed comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Closed Comedone Count||Full Range|Mean
2700954|NCT01237821|Primary|Facial Lesion Counts: Open Comedones|Participants were assessed for facial open comedomes and the total number present was recorded. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||Open Comedone Count||Full Range|Mean
2700955|NCT01237821|Primary|Facial Skin Assessment: Global Acne Assessment|The facial skin was assessed for global acne assessment on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700956|NCT01237821|Primary|Facial Skin Assessment: Overall Appearance|The facial skin was assessed for overall appearance on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700957|NCT01237821|Primary|Facial Skin Assessment: Appearance of Pores|The facial skin was assessed for the appearance of pores on a 10-point visual analog scale,with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700958|NCT01237821|Primary|Facial Skin Assessment: Skin Brightness|The facial skin was assessed for skin brightness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700959|NCT01237821|Primary|Facial Skin Assessment: Skin Smoothness|The facial skin was assessed for skin smoothness on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700960|NCT01237821|Primary|Facial Skin Assessment: Skin Tone (Clarity)|The facial skin was assessed for skin tone (clarity) on a 10-point visual analog scale with 0 indicating a favorable rating and 9 indicating an unfavorable rating. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700961|NCT01237821|Primary|Treatment Tolerability Assessment: Peeling|Participants were assessed for Peeling on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700962|NCT01237821|Primary|Treatment Tolerability Assessment: Dryness|Participants were assessed for Dryness on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700963|NCT01237821|Primary|Treatment Tolerability Assessment: Edema|Participants were assessed for Edema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700964|NCT01237821|Primary|Treatment Tolerability Assessment: Erythema|Participants were assessed for Erythema on a 4-point ordinal scale where 0= none; 1= mild; 2= moderate; and 3= severe. Assessments were made at baseline and weeks, 2, 4, 8, and 12, with the regression phase assessment at week 16.|16 weeks|Male and female 18-50 years old, mild to moderate acne vulgaris with >15 inflammatory lesions (papules/pustules) and >20 non-inflammatory lesions (black heads/white heads) on the face.|||score on a scale||Full Range|Mean
2700977|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700978|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700979|NCT01237613|Secondary|Return to Work and Previous Physical Activities||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700980|NCT01237613|Secondary|Subjective Evaluation of Treatment||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700981|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700965|NCT01237678|Secondary|Overall Survival (OS) Rate at 12 Months|OS was analyzed based on a binary definition of the number of patients dead or censored prior to 12 months and the number of patients alive at 12 months. The primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates. The control arm was primarily planned to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed. Further, the trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to OS and no determination of the OS rate at 12 months for the control arm was performed; therefore only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented.|12 months|A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.|||percentage of participants alive||95% Confidence Interval|Number
2700966|NCT01237678|Secondary|Median Overall Survival (OS) in Phase II|A secondary outcome measure for Phase II was to determine the overall survival of patients treated with IMGN901 in combination with carboplatin/etoposide chemotherapy versus carboplatin/etoposide chemotherapy alone as first-line treatment for patients with extensive stage small cell lung cancer.|From the time of enrollment until death on study due to any cause (up to post-treatment follow-up 28 days after last dose, up to 22 months)|A total of 121 patents were included in the analyses (82 in Arm1 and 39 in Arm 2) due to due to the lack of post-baseline evaluations for 20 participants.|||months||95% Confidence Interval|Median
2700967|NCT01237678|Secondary|Progression Free Survival (PFS) Rate at 6 Months|The trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to PFS. The activity of IMGN901 was assessed by comparing the PFS rate at 6 months in the IMGN901 experimental arm against the historical 6-month PFS rate of 0.44 (equivalently a median PFS = 5 months). Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the objective was to compare PFS at 6 months in the experimental arm (triplet combination) against the historical PFS rate of 0.44 (equivalently a median PFS = 5 months) for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.|6 months|A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.|||percentage of participants||95% Confidence Interval|Number
2700968|NCT01237678|Secondary|Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|To assess the type and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). An AE was defined as any noxious, pathologic, or unintended change un anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of the study, whether or not deemed study drug-related. An SAE was any AE resulting in death, life-threatening experience, initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, or congenital defect. All AEs were reported from the time of the first dose of study treatment until 28 days after the final dose of study drug. the severity of AEs were graded by the Investigator using National cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 4.0.|From the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment (up to 22 months)||||participants|||Number
2700969|NCT01237678|Primary|Maximum Tolerated Dose (MTD) of IMGN901|A primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. The MTD was determined based on DLTs that occurred during Cycle 1.|21 days (Cycle 1)|During escalation, carboplatin dosing was reduced from AUC 6 to AUC 5 due to poor tolerability; therefore the MTD for IMGN901 was determined in combination with carboplatin AUC5 and 100 mg/m^2 etoposide|||mg/m^2|||Number
2700970|NCT01237678|Primary|Progression Free Survival (PFS) in Phase II|The primary outcome measure for Phase II was to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer. PFS was defined as the time from enrollment until objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.|From randomization to objective tumor progression or death (up to post-treatment follow-up 28 days after last dose, up to 22 months)|A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.|||months||95% Confidence Interval|Median
2700971|NCT01237678|Primary|Occurrence of Dose Limiting Toxicities (DLT)|The primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) and characterize the dose limiting toxicities (DLT) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. For the purposes of dose escalation and determination of MTD, DLTs were defined as AEs or abnormal laboratory values related to study treatment which occurred in Cycle 1 of the Dose Escalation phase, including any AEs that resulted in failure to meet the criteria for re-treatment. The following events were considered DLTs (using the most current version of CTCAE): febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; ≥ Grade 3 peripheral neuropathy; ≥ Grade 3 vomiting, nausea, or diarrhea that persisted despite the use of optimal therapy; other ≥ grade 3 non-hematologic toxicity (with the exception of brief fatigue i.e. ≤ 72 hours and alopecia)|21 days (Cycle 1)|A total of 33 patients were analyzed as part of the Dose escalation phase.|||participants|||Number
2700972|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700973|NCT01237613|Secondary|Return to Work and Previous Physical Activities||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700974|NCT01237613|Secondary|Subjective Evaluation of Treatment||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700975|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
2700993|NCT01237587|Secondary|Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline MASC measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2700994|NCT01237587|Secondary|Change From Baseline in Children's Depression Inventory (CDI)|"Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CDI measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2700995|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)|"Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-parent measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2700996|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Child Form (FDI-child)|"Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-child measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2700997|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score|"Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI mental Illness measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2700998|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score|"Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI overall illness measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2700999|NCT01237587|Secondary|Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores|"Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for pain now, worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline PPQ measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2701050|NCT01237054|Primary|Count of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM.|18F-FDG PET CT and F18-NaF PET CT imaging results were compared in participants with MGUS, SMM, and MM. Lesions were considered positive if focal uptake corresponded to lesions identified on CT for NaF and negative if no uptake seen in lesions. Criteria to define FDG positivity included parameters published by Zamagni et al with focal abnormal uptake more intense than background.|60 days||||Participants|||Count of Participants
2701000|NCT01237587|Secondary|Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items|"The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline BPI severity & interferences items scores.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
2701001|NCT01237587|Secondary|Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.|Baseline, 13 weeks|"All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline MASC score.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|||units on a scale||Standard Error|Least Squares Mean
2701002|NCT01237587|Secondary|Change From Baseline in Children's Depression Inventory (CDI)|"Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CDI score.|||units on a scale||Standard Error|Least Squares Mean
2701003|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)|"Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI-parent scale score.|||units on a scale||Standard Error|Least Squares Mean
2701004|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)|"Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI child scale score.|||units on a scale||Standard Error|Least Squares Mean
2701005|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score|"Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S mental illness score.|||units on a scale||Standard Error|Least Squares Mean
2701006|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score|"Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S overall illness score.|||units on a scale||Standard Error|Least Squares Mean
2701383|NCT01235338|Primary|Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
2701384|NCT01235338|Primary|Tmax of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
2701007|NCT01237587|Secondary|Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores|"Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for pain now, worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline PPQ score.|||mm||Standard Error|Least Squares Mean
2701008|NCT01237587|Secondary|Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF)."|13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.|||Participants|||Count of Participants
2701009|NCT01237587|Secondary|Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF)."|13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.|||Participants|||Count of Participants
2701010|NCT01237587|Secondary|Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase."|Baseline (Extension Phase), 39 weeks|All randomized participants in duloxetine only arm with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.|||units on a scale||Standard Deviation|Mean
2701011|NCT01237587|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items|"The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.~MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI severity & interferences items score.|||units on a scale||Standard Error|Least Squares Mean
2701012|NCT01237587|Primary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.|||units on a scale||Standard Error|Least Squares Mean
2701013|NCT01237353|Secondary|Duration of Gastric pH Status|When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours|2 hours after dose of betaine HCl||||minutes||Standard Deviation|Mean
2701014|NCT01237353|Primary|Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)|Gastric pH levels monitored with a Heidelberg pH capsule (HC) which sends real-time signals to a computer system that visually plots intestinal pH on a minute-by-minute basis. When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours.|30 minutes||||units on a scale||Standard Deviation|Mean
2701015|NCT01237340|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection).|Day 1 up to 28 days after last dose of study treatment|Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment.|||participants|||Number
2701016|NCT01237340|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||nmol/L||Standard Deviation|Mean
2701017|NCT01237340|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)|Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.|Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."|||standard deviation score||Standard Deviation|Mean
2701018|NCT01237340|Secondary|Insulin-like Growth Factor-I (IGF-1) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."|||nanomole per liter (nmol/L)||Standard Deviation|Mean
2701019|NCT01237340|Secondary|Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®|Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.|Baseline up to Week 26|MITT population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.|||participants|||Number
2701020|NCT01237340|Primary|Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®|Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.|Baseline up to Week 26|Modified Intent-to-Treat (MITT) population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.|||participants|||Number
2701021|NCT01237327|Secondary|Time to Treatment Failure (TTF)|TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.|Every 12 weeks up to 6 years|ITT|||months||95% Confidence Interval|Median
2701022|NCT01237327|Secondary|Time to Tumor Progression (TTP)|TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.|Every 12 weeks up to 6 years|ITT|||months||95% Confidence Interval|Median
2701023|NCT01237327|Secondary|Duration of Response (DR)|Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.|Every 12 weeks up to 6 years|ITT.|||months||95% Confidence Interval|Median
2701024|NCT01237327|Secondary|Objective Response Rate (ORR)|Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group|Every 12 weeks up to 6 years|ITT|||percentage of participants|||Number
2701025|NCT01237327|Primary|Overall Survival|Overall survival in months measured from date of starting treatment in core study to date of death for any reason.|Every 12 weeks up to 6 years|Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.|||months||95% Confidence Interval|Median
2701026|NCT01237301|Secondary|Change From Baseline in CGM Glucose Variability|Glucose Variability - Interquartile Range used to determine incremental benefit of CGM for clinical decision making. IQR results reflect the change delta from baseline to 16 weeks. IQR is calculated for each subject at each visit. The change in IQR was calculated as final IQR minus baseline IQR. This measure represents an average of the individual subjects IQR delta (baseline to 16 weeks/final).|Baseline and 16 weeks||||mg/dL||Standard Deviation|Mean
2701027|NCT01237301|Secondary|Percent of Time in Hypoglycemia Range|"The secondary objective is to determine the incremental benefit of CGM for clinical decision-making using percent time in hypoglycemia range (< 50 mg/dL). Numerator: amount of time with a value of 49 mg/dL or less. Denominator: total amount of time of CGM measurement.~CGM used for this study produced measurements once every 15 minutes or 360 times per day."|16 weeks||||% of time in hypoglycemia||Standard Deviation|Mean
2701028|NCT01237301|Secondary|Glucose Exposure (Area Under the Diurnal Median Curve)|The secondary objective is to determine the incremental benefit of CGM for clinical decision-making by using (area under the diurnal median curve). Data was collected to create the curve at every hour of modal day. Example: hours 1-24 of each day. Modal day reflects 14 days worth of CGM data aggregated into a single 24 hour day graph.|16 weeks||||mcg*hr/mL||Standard Deviation|Mean
2701029|NCT01237301|Primary|Percentage Change in Hemoglobin A1c||2 week baseline to 16 week final|Per Protocol|||percentage of HbA1c||Standard Deviation|Mean
2701030|NCT01237223|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.|8 weeks|Safety set: All patients who received at least one dose of double-blind study medication.|||Participants|||Number
2701031|NCT01237223|Secondary|Percentage of Participants Achieving a Successful Response Rate|The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication|||percentage of participants|||Number
2701032|NCT01237223|Secondary|Percentage of Participants Achieving Blood Pressure Control at Endpoint|Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication|||percentage of participants|||Number
2701385|NCT01235338|Primary|Tmax of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
2701386|NCT01235338|Primary|Tmax of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
2701033|NCT01237223|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.|||mm Hg||Standard Error|Least Squares Mean
2701034|NCT01237223|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.|||mm Hg||Standard Error|Least Squares Mean
2701035|NCT01237197|Primary|Percent Change From Baseline in Body Mass Index at 3-months|As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.|Baseline and 3-months||||percentage of change in BMI||Standard Deviation|Mean
2701036|NCT01237080|Primary|Time to Intubate||From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.|The sample size was calculated to 40 in each group (50 patients were included in each group): minimum relevant difference in intubation time of 20 s and a standard deviation of 28 s. A significance level of 0.05 and an acceptable risk of Type 2 error of 0.1 were used.|||sec||95% Confidence Interval|Mean
2701037|NCT01237080|Secondary|Postoperative Throat Pain.||one hour postoperative|||||||
2701038|NCT01237080|Secondary|Postoperative Hoarseness.||one hour postoperative.|||||||
2701039|NCT01237080|Secondary|Intubation of the Esophagus.||detected immediately|||||||
2701040|NCT01237080|Secondary|Subjectively Intubation Difficulty||measured immediately on a visual analogue scale.|||||||
2701041|NCT01237080|Secondary|Mucosal Lesion||inspection during intubation and one hour postop.|||||||
2701042|NCT01237080|Secondary|Lowest Saturation During Intubation.||measured on the monitor|||||||
2701043|NCT01237080|Primary|Number of Patients Intubated in the First Attempt|The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).|please see description||||participants|||Number
2701044|NCT01237054|Secondary|Comparison of Microvessel Density (MVD) Between MGUS and SMM/MM Groups|Microvessel density was estimated by determining the average number of CD34-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification).|60 days|Serum was not available for three patients in the SMM group.|||microvessels/hpf||Standard Error|Mean
2701045|NCT01237054|Secondary|Comparison of Serum Angiogenic Marker Reverse Contrast Transfer Rate (Kep) Between MGUS and SMM/MM Groups|Pharmacokinetic parameter Kep was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).|60 days|Serum was not available for three patients in the SMM group.|||per min||Standard Error|Mean
2701046|NCT01237054|Secondary|Comparison of Reverse Contrast Transfer Rate (Kep) and Forward Contrast Transfer Rate (Ktrans) Among Patients With MGUS, SMM, and MM|Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).|60 days|Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.|||per min||Full Range|Median
2701047|NCT01237054|Secondary|Comparison of Microvessel Density (MVD) Among Patients With MGUS, SMM, and MM|Microvessel density was estimated by determining the average number of cluster of differentiation 34 (CD34)-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification). Large vessels and vessels in the periosteum on bone were excluded. Areas of staining with no discrete breaks were counted as a single vessel. The presence of a lumen was not required.|60 days|Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.|||microvessels/hpf||Full Range|Median
2701048|NCT01237054|Secondary|Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups|The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.|60 days|Serum was not available for three patients in the SMM group.|||pg/ml||Standard Error|Mean
2701049|NCT01237054|Primary|Count of Participants With Positive DCE-MRI Imaging Results|DCE-MRI, an FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA). The criteria was presence of early and diffuse hyper-enhancement compared to the surrounding bone marrow. The pattern of marrow involvement on MRI was characterized as: (1) normal when there was no evidence of abnormal signal intensity; (2) focal, which consisted of localized areas of abnormal marrow; the lesions are darker than yellow marrow and slightly darker than or isointense to red marrow on T1-weights images; (3) diffuse, in which normal bone marrow signal intensity is completely absent, the intervertebral disks appear brighter than or isointense to the diseased marrow; and finally (4) heterogeneous that consists of innumerable small foci of disease on a background of intact marrow, with small dark lesions on T1-weighted images, which become bright on T2-weighted image.|60 days|Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.|||Participants|||Count of Participants
2701387|NCT01235338|Primary|Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
2701388|NCT01235338|Primary|AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
2701051|NCT01237041|Secondary|Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours|Effect of niacin vs placebo on Somatostatin (SST) Area Under the Curve in response to Niacin and Placebo over 4 hours. For somatostatin, samples collected at 0, 60, 120, 180, and 240 minutes.|4 hours|Dose-establishing participants did not have placebo, so there are no data for those cells. Dose-establishing study 1 niacin 250mg participants did not have somatostatin measured, so those cells are also not completed|||min*pg/mL||Standard Deviation|Mean
2701052|NCT01237041|Secondary|Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours|Growth hormone-releasing hormone (GHRH) Area Under the Curve in response to Niacin and Placebo over 4 hours. For GHRH, samples collected at 0, 60, 120, 180, and 240 minutes.|4 hours|Dose-establishing participants did not have placebo, so there are no data for those cells.|||min*pg/mL||Standard Deviation|Mean
2701053|NCT01237041|Secondary|Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours|Effect of niacin vs placebo on Free Fatty Acids (FFA) Area Under the Curve in response to Niacin and Placebo over 4 hours. For FFA, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes|4 hours|Dose-establishing participants did not have placebo, so there are no data for those cells.|||Min*UEq/L||Standard Deviation|Mean
2701054|NCT01237041|Primary|Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time|Growth hormone Area Under the Curve in response to niacin versus placebo over 4 hours. For growth hormone, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.|4 hours|No placebo was given during the dose-establishing arms, so no data are reported for placebo.|||min*ng/mL||Standard Deviation|Mean
2701055|NCT01236768|Other Pre-specified|Adhesion at Application Site|"Measurement of adhesion of application site is defined as follows:~0: >=90% adhered (no lifting)~>=75% adhered but <90% (some edges showing lifting)~>=50% adhered but <75% (half of the patch lifts off)~<50% (> half of patch lifts off, but not detached)~patch completely detached"|6 months|Subjects that have documented adhesion scores.|||Score||Standard Deviation|Mean
2701056|NCT01236768|Other Pre-specified|Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)|Measurement of plasma levels of levonorgestrel and ethinyl estradiol.|3 months and 6 months|Number of subjects with available LNG data for cycle 3 or cycle 6|||pg/mL||95% Confidence Interval|Mean
2701057|NCT01236768|Other Pre-specified|Irritation and Itching at Application Site|"AG200-15 irritation and itching scores are defined as follows:~0=none~mild~moderate~severe"|6 months|Subject self-reported worse irritation score in a cycle.|||Score||Standard Deviation|Mean
2701058|NCT01236768|Other Pre-specified|Cycle Control|The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.|6 months|Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle.|||percent cycles with BTB or BTS|||Number
2701059|NCT01236768|Secondary|Safety|Adverse events|6 months|Any subject who applied a patch.|||Events|||Number
2701060|NCT01236768|Primary|Pregnancy Reported as Pearl Index|Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|6 months|Intent-to-treat population ages 18-35.|||Pearl Index||95% Confidence Interval|Number
2701061|NCT01236755|Secondary|Number of Participants With Serious Adverse Effects|Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva|14 months||||Participants|||Count of Participants
2701062|NCT01236755|Primary|Change in Axial Elongation in the Two Study Phases|Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology|14 months||||mm||Standard Deviation|Mean
2701063|NCT01236742|Secondary|Incidence of Adverse Effects|The observation of serious and non-serious adverse events in the 14 months of study period|14 months||||Participants|||Count of Participants
2701064|NCT01236742|Primary|Change in Axial Length|To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects|Baseline, 7 months, and 14 months after baseline||||mm||Standard Deviation|Mean
2701065|NCT01236534|Secondary|Number of Participants With Diarrheic Events.|To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.|21 days|per protocol|||participants|||Number
2701066|NCT01236534|Primary|Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.|Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.|21 days|per protocol|||spontaneous bowel movements||Standard Deviation|Mean
2701067|NCT01236391|Secondary|Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score|Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.|From Baseline to Cycle 5 (Week 20)||||scores on a scale||Standard Deviation|Mean
2701068|NCT01236391|Secondary|PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)|Performed During the First Month of Receiving PCI-32765|PK samples were collected in a subset of participants (n=48) in this trial (n=111). PK parameters reported here reflects those that were PK evaluable from the 48 participants.|||AUC0-24h (ng*h/mL)||Standard Deviation|Mean
2701069|NCT01236391|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure||||participants|||Number
2701389|NCT01235338|Primary|AUC of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
2701070|NCT01236391|Primary|Percentage of Participants Achieving Response|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.|The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population|||percentage of participants with response||95% Confidence Interval|Number
2701071|NCT01236365|Secondary|Descending Aortic Strain|Subclinical atherosclerosis and arterial stiffness of abdominal aortic MRI|Randomization|Project #3. Study Subjects were given the option to participate in the Project #3 MRI substudy; 11 Atorvastatin and 8 Placebo Subjects participated in Project #3.|||percent area change||Standard Deviation|Mean
2701072|NCT01236365|Secondary|RAGE|Receptor for Advanced Glycation End Products|Randomization and 6 months|Project #2. Study Subjects were given the option to participate in the Project #2 genetic substudy; 9 Atorvastatin and 12 Placebo Subjects participated in Project #2. 1 Atorvastatin and 1 Placebo Subject did not complete the 6 month genetic test.|||pg/mL||Standard Error|Mean
2701073|NCT01236365|Secondary|MAGE|Mean amplitude of glycemic excursion (MAGE) with continuous glucose monitoring (CGM - IPro®, Medtronic Minimed) worn blindly for 6d to assess glucose variability|Randomization and 6 months|Project #1. 4 Atorvastatin and 8 Placebo Subjects did not complete their CGM at 6months.|||mg/dL||Standard Error|Mean
2701074|NCT01236365|Primary|Hs-CRP Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.|Randomization and 6 months|Project #1|||mg/dL||Inter-Quartile Range|Median
2701075|NCT01236365|Primary|LDL-C Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C >100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.|Randomization and 6 months|Project #1. Adjusted for age, gender and ISS (Insulin sensitivity score)|||mg/dL||Standard Error|Mean
2701076|NCT01236339|Secondary|Liver Disease Complications (Adverse Events)|Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.|Through 24 months||||participants|||Number
2701077|NCT01236339|Secondary|Procedural Success|"Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein~*Note: Control (LVP) arm includes only subjects who crossed over to TIPS"|Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)||||participants|||Number
2701078|NCT01236339|Secondary|Frequency of Hepatic Encephalopathy|Number of episodes of West Haven grade 2 or greater|Through 24 months||||Number of episodes|||Number
2701079|NCT01236339|Secondary|Frequency of Paracentesis|Number of paracentesis post randomization|Through 24 months||||Number of episodes|||Number
2701080|NCT01236339|Secondary|Time to Transplant|"Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant.~*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination."|Through 24 months||||participants|||Number
2701081|NCT01236339|Secondary|Overall Survival|"Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. >~*Note: Outcome measure entered below is number of subjects alive at time of study termination."|Through 24 months||||participants|||Number
2701082|NCT01236339|Primary|Transplant-free Survival|"Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up.~Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination."|Through 24 months||||participants|||Number
2701083|NCT01235923|Primary|Reticulocyte Count|reticulocyte count at 4 weeks (end of study)|4 weeks|Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power.|||cells x 1000/microliter||Standard Error|Mean
2701084|NCT01235923|Primary|Baseline Retic Count|retic count measured at study entry|baseline|All study subjects had baseline retic count measured.|||x1000 cells/microliter||Standard Error|Mean
2701085|NCT01235793|Primary|Safest Dose of Temozolomide for the DRBEAT Regimen|Safety will be assessed using a dose escalation design for temozolomide's use to determine the target dose and also to evaluate any and all acute treatment related toxicities. During the course of patient follow up and therapy, toxicities will be evaluated, particularly as the investigators will be determining the target dose of temozolomide. One of the major criteria for dose limiting toxicity for the study will be any Grade 3 or 4 nonhematologic toxicity from a list of commonly expected toxicities associated with autologous transplantation and temozolomide.|One Year||||dose in mg/m^2||95% Confidence Interval|Number
2701086|NCT01235793|Primary|One-year Progression-free Survival and Overall Survival|"Efficacy of the DRBEAT Regimen will be assessed by analysis of~one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression*, or death, (*Progression is defined as meeting the response criteria listed in Table 4: Response Criteria for Primary Central Nervous System Lymphoma according to Abrey LE, Batchelor TT, Ferreri AJM et al.)~and~Overall survival, defined as the time interval between the date of transplant and the date of death from any cause."|(1) One Year (2) Until date of death from any cause, assessed up to 2 years||||Days||95% Confidence Interval|Median
2701087|NCT01236573|Primary|Response (Complete Response (CR) + Partial Response (PR)) to Therapy|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline um LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions.|4 years||||participants|||Number
2701088|NCT01236573|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|49 months and 20 days||||participants|||Number
2701089|NCT01236573|Primary|Maximum Tolerated Dose (MTD)|The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10^6, 3x10^6, 3x10^7, 1x10^7, 3x10^7, 1x10^8, 3x10^8, 1x10^9, and 3x10^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which </= 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)).|4 years||||Cells|||Number
2701090|NCT01236521|Secondary|SF-36 Social Functioning Scale|The SF-36 social functioning scale is a subscale that assesses the self-reported social functioning. It is scored on a 0 to 100 scale with higher scores representing better social functioning.|Baseline||||scores on a scale||Standard Deviation|Mean
2701091|NCT01236521|Secondary|SF-36 Vitality Scale|The SF-36 vital score is a subscale that assesses participants' vitality/energy. It is scored on a 0 to 100 scale with higher scores representing greater vitality/energy.|baseline||||scores on a scale||Standard Deviation|Mean
2701092|NCT01236521|Secondary|SF-36 General Health Perception|The SF-36 is a subscale that assesses the self-reported general health. It is scored on a 0 to 100 scale with higher scores representing greater perceived general health|baseline||||scores on a scale||Standard Deviation|Mean
2701093|NCT01236521|Secondary|Current Opioid Misuse Measure (COMM)|The COMM (Current Opioid Misuse Measure) is a 17-item instrument designed to monitor misuse and aberrant behaviors in patients prescribed opioids. The scale is scored from 0 (no evidence of opioid misuse or aberrant behaviors) to 64 (strong evidence for opioid misuse and aberrant behaviors)|baseline||||scores on a scale||Standard Deviation|Mean
2701094|NCT01236521|Secondary|AUDIT-C|The AUDIT-C is validated as an effective screening test and diagnostic tool for alcohol misuse in primary care samples. It is scored on 0 to 10 score with higher scores representing alcohol misuse|Baseline||||scores on a scale||Standard Deviation|Mean
2701095|NCT01236521|Secondary|Generalized Anxiety Disorder 7-item (GAD-7) Scale|The GAD-7 is a measure of anxiety. The GAD-7 consists of 7 items that are scored from 0 (no anxiety) to 21 (severe anxiety)|Baseline||||scores on a scale||Standard Deviation|Mean
2701096|NCT01236521|Secondary|Patient Health Questionnaire-9|The Patient Health Questionnaire-9 is used to assess depression severity. It's 9-items that are scored from 0 (no depression) to 27 (severe depression)|Baseline||||scores on a scale||Standard Deviation|Mean
2701097|NCT01236521|Secondary|Roland Morris Disability Scale|The Roland Morris Disability Scale is a 24-item pain-specific measure of physical disability. It provides a score from 0 (no disability) to 24 (high disability)|Baseline||||scores on a scale||Standard Deviation|Mean
2701098|NCT01236521|Secondary|Pain Catastrophizing Scale|The Pain Catastrophizing Scale a 13-item scale that assesses catastrophizing - a pain belief that have been found to be strong predictor of poor treatment response. It is scored from 0 (no catastrophizing) to 52 (severe catastrophizing)|baseline||||scores on a scale||Standard Deviation|Mean
2701099|NCT01236521|Primary|Brief Pain Inventory Pain Interference Scale Score|The Brief Pain Inventory Pain Interference Scale score assesses if pain interferes with 7 common activities. This scale is score 0 (no interference) to 10 (high interference). The 7-items are averaged to give a score.|Baseline and 3, 6, 9, and 12 months|We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.|||scores on a scale||Standard Deviation|Mean
2701100|NCT01236521|Primary|Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point|The Brief Pain Inventory pain intensity score is scored from 0 (no pain) to 10 (worst pain imaginable). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.|Baseline and 3, 6, 9, and 12 months|We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.|||units on a scale||Standard Deviation|Mean
2701101|NCT01236521|Primary|Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months|The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.|Baseline and 3, 6, 9, and 12 months|We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.|||units on a scale||Standard Deviation|Mean
2701102|NCT01236378|Secondary|Number of Participants With Estimated Glomerular Filtration Rate (GFR) Less Than (<) 60 mL/Min/1.73 m^2|GFR, an index of kidney function, describes flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using the Simplified Modification of Diet in Renal Dysfunction (MDRD) GFR equation. Normal GFR is >90 mL/min/1.73 m^2; children and older people usually have lower GFR. Often, kidney transplant recipients do not have normal GFRs. Lower values indicate poor kidney function. GFR <15 mL/min/1.73 m^2 is consistent with kidney failure. For this posting, the number of subjects with a GFR <60 mL/min/1.73 m^2 is listed.|From baseline up to Day 4|All participants.|||participants|||Number
2701390|NCT01235338|Primary|AUC of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
2701103|NCT01236378|Secondary|Number of Participants With Serum Creatinine Levels More Than (>) 1.3 Times the Upper Limit of Normal|Serum creatinine, an indicator of kidney function, formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue, is removed from blood by kidneys and excreted in urine. Increased creatinine in blood indicates decreased kidney function. Creatinine levels are age, gender and race dependent as they are related to an individual's muscle mass. Renal transplant recipients may have elevated serum creatinine. For this study an abnormal serum creatinine level is defined as 1.3 times the upper limit of normal (ULN) for the laboratory where the determination was performed.|From baseline up to Day 4|All participants.|||participants|||Number
2701104|NCT01236378|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||liter per hour (L/h)||Standard Deviation|Mean
2701105|NCT01236378|Primary|Degree of Fluctuation (DF)|DF, also known as peak to trough fluctuation (PTF) (calculated as [Cmax minus Ctrough] divided by Cave), is a unit-less ratio of the Cmax to Ctrough decrease expressed as a fraction of the average concentration during a dosing interval.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||ratio||Standard Deviation|Mean
2701106|NCT01236378|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2701107|NCT01236378|Primary|Average Blood Concentration at Steady State (Cave,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||ng/mL||Standard Deviation|Mean
2701108|NCT01236378|Primary|Observed Blood Trough Concentration at Steady State (Ctrough,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||ng/mL||Standard Deviation|Mean
2701109|NCT01236378|Primary|Time to Reach Maximum Observed Blood Concentration at Steady State (Tmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||hours||Full Range|Median
2701110|NCT01236378|Primary|Maximum Observed Blood Concentration at Steady State (Cmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK parameter analysis population: All treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2701111|NCT01236352|Secondary|Ratio of BMS-926796 AUC(INF) to BMS-911543 AUC(INF) After 1st Dose and BMS-926796 AUC(TAU) to BMS-911543 AUC(TAU) on Day 15 (AUC Ratio)|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC Ratio = Ratio of BMS-926796 AUC(INF) to BMS-911543 AUC(INF) after 1st dose and BMS-926796 AUC(TAU) to BMS-911543 AUC(TAU) on Day 15|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701112|NCT01236352|Secondary|Accumulation Index (AI): Ratio of AUC(TAU) on Day 15 to AUC(TAU) After the First Dose of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Accumulation index (AI) = ratio of AUC(TAU) on Day 15 to AUC(TAU) after the first dose of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701113|NCT01236352|Secondary|Apparent Volume of Distribution After First Dosing Based on the Terminal Phase (for Parent Compound Only) (Vz/F) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Vz/F = Apparent volume of distribution after first dosing based on the terminal phase (for parent compound only) of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701114|NCT01236352|Secondary|Apparent Total Clearance (for Parent Compound Only) (CLT/F) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: CLT/F = Apparent total clearance (for parent compound only) of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701115|NCT01236352|Secondary|The Terminal-phase Elimination Half-life in Plasma (T-HALF) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: T-HALF = The terminal-phase elimination half-life in plasma of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701116|NCT01236352|Secondary|Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC (TAU) = Area under the concentration-time curve in one dosing interval of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701376|NCT01235403|Secondary|Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period|"The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.~The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase."|End of Treatment Period (24-week)|Safety Set|||percentage of subjects|||Number
2701117|NCT01236352|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (for Single Dose Period Only) (AUC(0-T)) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC (0-T) = Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration (for single dose period only) of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701118|NCT01236352|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (for Single Dose Period Only) (AUC(INF)) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: AUC(INF) = Area under the plasma concentration-time curve from time zero extrapolated to infinite time (for single dose period only) (AUC(INF)) of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701119|NCT01236352|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Tmax = Time of maximum observed plasma concentration (Tmax) of BMS-911543 and it's metabolite Met4|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701120|NCT01236352|Secondary|Trough Observed (Pre-dose) Plasma Concentration (Cmin) of BMS-911543 and it's Metabolite Met4|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Cmin (Trough observed (pre-dose) plasma concentration)|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701121|NCT01236352|Secondary|Maximum Observed Plasma Concentration (Cmax) of BMS-911543 and it's Metabolite BMS-926796 (Met4)|Pharmacokinetic parameters of BMS-911543 and BMS-926796 (Met4) metabolite, will be derived from plasma concentration versus time. The pharmacokinetic parameters to be assessed include: Cmax Maximum observed plasma concentration|Day -1, Day 1, Day 8, Day 15, Day 21 and Day 28 or off-study|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701122|NCT01236352|Secondary|Changes in (Janus Kinase) JAK/Signal Transducers and Activators of Transcription (STATs) Pathway Activities, Circulating CD34+ Cells and Plasma Cytokine Levels|JAK/STAT pathway activity will be evaluated by: 1) pSTATs levels using immunoassay; 2) expression levels of several JAK/STATs pathway genes. Whole blood will be collected at specific time-points. Due to portfolio/business decisions by the sponsor, the compound is no longer being developed and the study was terminated. Analysis was not completed because the study was terminated. This decision was not based on any safety concerns associated with BMS-911543.|Up to 6 months|Data for this outcome measure was not collected for any participants because the study was terminated||||||
2701123|NCT01236352|Primary|Number of Participants With Best Overall Response|Participants were clinically assessed for IWG-(International Working Group consensus criteria for treatment response in myelofibrosis with myeloid metaplasia) defined response at each returning on-treatment visit and the first post-treatment visit. IWG-MRT criteria for best overall response are ordered high to low: CR>PR>CI>SD>PD>R where CR = Complete Remission, PR= Partial Remission, CI = Clinical Improvement, SD = Stable Disease, PD = Progressive Disease and R = Relapse. Best overall response is the best response of the subject during the treatment period or at the first post-treatment visit.|Day 1, at each returning on-treatment visit and the first post-treatment visit|All treated participants|||Participants|||Count of Participants
2701124|NCT01236352|Primary|Number of Participants With Adverse Events|Safety assessments were based on a medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests and were evaluated for all treated participants using National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v.4.0).|From the date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occured at a later time, assessed up to 4.5 years|All treated participants|||Participants|||Count of Participants
2701125|NCT01236326|Secondary|Recovered by 2 Months After Donation||2 months|The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).|||participants|||Number
2701126|NCT01236326|Secondary|Days to Normal Day-to-day Activities||2 months|The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).|||days||Standard Deviation|Mean
2701127|NCT01236326|Secondary|Days Before Going Back to Work||2 months|The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).|||days||Standard Deviation|Mean
2701128|NCT01236326|Secondary|Days on Oral Pain Medication After Discharge||2 months|The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).|||days||Standard Deviation|Mean
2701129|NCT01236326|Primary|The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.|"The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity."|1 year|The number of participants analyzed is lower than the number of baseline participants because overall, 25% of subjects did not return the 2-month questionnaire (26.5% of the LESS-DN group and 23.5% of the Conventional LDN group).|||days||Standard Deviation|Mean
2701391|NCT01235338|Primary|AUC of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
2701130|NCT01236300|Primary|NPV (Negative Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
2701131|NCT01236300|Primary|PPV (Positive Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
2701132|NCT01236300|Primary|Specificity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
2701133|NCT01236300|Secondary|Overall Complication Rate|Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure|August 2011||||percentage of participants||95% Confidence Interval|Number
2701134|NCT01236300|Primary|Sensitivity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
2701135|NCT01236196|Primary|Pain Intensity|Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2701136|NCT01236196|Primary|Pain Behavior|Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2701137|NCT01236196|Primary|Depressive Symptoms|Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2701138|NCT01236196|Primary|Level of Functioning|Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2701139|NCT01236170|Secondary|Wheelchair Activity||over a two week period following baseline|Access to data is no longer available.||||||
2701204|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.|3 months|Of the 192 subjects in the Safety Set (SS), 152 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.|||percentage of participants|||Number
2701140|NCT01236170|Secondary|Participation in Society|"We assessed participation in society with a modified version of the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF). The CHART was designed to provide a simple measure of involvement in life situations (In a typical week, how many days do you get out of your house and go somewhere?) with sub-scales measuring physical independence, cognitive independence, mobility, occupation, social integration and economic self-sufficiency. The CHART-SF produces scores ranging from 0 (severe handicap) to 100 (no handicap) for each of the sub-scales and a total score ranging from 0-600. The CHART-SF is the most widely used participation measure in rehabilitation research. It has been used in various ethnic groups, and has well-established psychometric properties (test-retest reliability = .93; inter-rater reliability = .83). We dichotomized into Disabled and Not Disabled where disabled are those with a CHART score <100, and not disabled are those with a CHART score >=100"|Measured at baseline|452/482 participants were included in this analysis because 30 participants had missing data.|||participants|||Number
2701141|NCT01236170|Secondary|Satisfaction With Prescribed Wheelchair|"We assessed Satisfaction with patients' prescribe wheelchair using the Quebec User Evaluation of Satisfaction with assistive Technology ( (QUEST). We used an 8-item subset of the QUEST to assess patients' satisfaction with their wheelchair. QUEST is the first and only standardized satisfaction assessment tool that was designed specifically for assistive technology devices. Its' development was based on major theoretical models of assistive technology. The QUEST has been widely cited and used in clinical and research settings, and demonstrates strong psychometric properties (Cronbach's alpha = .82). The 8 item subset focuses specifically on patients' satisfaction with different aspects of their wheelchair (e.g., How satisfied are you with the dimensions (size, height, length, width) of your assistive device?). Responses range from 1(not satisfied at all) to 5(very satisfied). Cronbach's alpha = .80 for the 8-item wheelchair subset. We chose to eliminate the other four items."|one time use, at baseline||||units on a scale||Standard Deviation|Mean
2701142|NCT01236170|Secondary|Satisfaction With Wheelchair Service Delivery|"The investigators assessed Satisfaction with Wheelchair Service Delivery using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily administered and scored measure of client satisfaction with services (e.g., How would you rate the quality of service you have received?). For the purpose of this study, the investigators asked patients to focus specifically on satisfaction with service at their SCI or AL wheelchair clinic. The scale is unidimensional, yielding a homogenous estimate of general satisfaction with services. It is scored by summing the individual items and produces a score ranging from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has been extensively used in a variety of healthcare settings, operates similarly across ethnic groups, and demonstrates excellent psychometric properties (Cronbach's alpha = .83-.93)."|one time use, at baseline||||units on a scale||Standard Deviation|Mean
2701143|NCT01236170|Primary|Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12)|The investigators will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12) and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach's alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. The investigators assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).|Measured at baseline|Only 468/482 participants were included in this analysis due to 14 participants having missing data.|||units on a scale||Standard Deviation|Mean
2701144|NCT01236118|Primary|Number of Participants With Adverse Events (AEs) [Clinically Significant Events]|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to Week 56)|All enrolled participants.|||participants|||Number
2701145|NCT01236105|Secondary|Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276|Tmax, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.|||hours (h)||Full Range|Median
2701146|NCT01236105|Primary|Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,|Cmax estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2701147|NCT01236105|Primary|Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276|AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2701148|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701392|NCT01235338|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
2701149|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701150|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701151|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701152|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701153|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701154|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701219|NCT01235975|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2701155|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701156|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701157|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701158|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701159|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701160|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701393|NCT01235338|Primary|Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
2701161|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was same as for case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701162|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was the same as case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701163|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701164|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701165|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701166|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2726542|NCT01048541|Primary|Mean Residual Urine Volume|Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation|3 catheterisations on 1 day||||mL||Standard Deviation|Mean
2701167|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701168|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701169|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701170|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701171|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR/95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701172|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701300|NCT01235689|Secondary|Time to Crohn's Disease-related Hospitalization Due to Emergency|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
2701173|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701174|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701175|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701176|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701177|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701178|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701301|NCT01235689|Secondary|Number of Crohn's Disease-related Surgical Procedures After Randomization|The total number of CD-related surgical procedures included major CD-related surgery, debridement, perineal related surgery - abscess drainage, seton placement, fistulotomy, and TPN.|From Randomization through 48 weeks after Randomization|All randomized participants|||surgical procedures|||Number
2701179|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701180|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701181|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701182|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701183|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701184|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701302|NCT01235689|Secondary|Total Length of Stay in Hospital for Crohn's Disease-related Hospitalizations||From Randomization through 48 weeks after Randomization|Randomized participants with Crohn's disease-related hospitalizations|||days||Standard Deviation|Mean
2726543|NCT01048502|Secondary|Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.||baseline and 6-8 weeks||||pg/mL||Standard Deviation|Median
2701185|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701186|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701187|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701188|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701189|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701190|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57 -105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701303|NCT01235689|Secondary|Total Length of Stay in Hospital for All-cause Hospitalizations||From Randomization through 48 weeks after Randomization|Randomized participants with all-cause hospitalizations|||days||Standard Deviation|Mean
2701191|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701192|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident Anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701193|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701194|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701195|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.3-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 m.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701196|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip]), T 2 (3-7 prescrip), T 3 (8-298 prescrip). Tertiles without 2 yr lag: T 1 (1-2 prescrip), T 2 (3-7 prescrip), and T 3 (8-388 prescrip). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701394|NCT01235338|Primary|Cmax of o-Desmethylvenlafaxine|Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.|Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
2701197|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701198|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701199|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701200|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701201|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701202|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
2701203|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason|6 months|Of the 192 subjects in the Safety Set (SS), 168 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.|||percentage of participants|||Number
2701205|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.~Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.|||percentage of participants|||Number
2701206|NCT01236001|Secondary|Treatment Persistence of VIMPAT® After 6 Months|Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (>=6 months).|>=6 months|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.|||percentage of participants|||Number
2701207|NCT01236001|Secondary|Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment|Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.|From baseline to study termination (6 months)|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.|||percentage of patients|||Number
2701208|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.|||participants|||Number
2701209|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.|||participants|||Number
2701210|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.~VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.|||participants|||Number
2701211|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 6 Months||6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.|||mg/day of Vimpat||Standard Deviation|Mean
2701212|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 3 Months||3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.|||mg/day of Vimpat||Standard Deviation|Mean
2701213|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at Baseline|Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.|||mg/day of Vimpat||Standard Deviation|Mean
2701214|NCT01235975|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2701215|NCT01235975|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2701216|NCT01235975|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated cohort (TVC), which cohort included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2701217|NCT01235975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|Within 4 days (Day 0 to 3) post-vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
2701218|NCT01235975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|Within 4 days (Day 0 to 3) post-vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
2701304|NCT01235689|Secondary|Number of All-cause Hospitalizations After Randomization|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic.|From Randomization through 48 weeks after Randomization|All randomized participants|||hospitalizations|||Number
2701220|NCT01235975|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2701221|NCT01235975|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).|At Day 0 and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.|||μg/mL||95% Confidence Interval|Geometric Mean
2701222|NCT01235975|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).|At Day 0 and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.|||Participants|||Count of Participants
2701223|NCT01235975|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|At Day 0 and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.|||Participants|||Count of Participants
2701224|NCT01235975|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2701225|NCT01235975|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2701226|NCT01235975|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2701227|NCT01235975|Primary|Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)|Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.|One month after vaccination (Month 1)|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2701228|NCT01235949|Secondary|Antibody Titers Against Poliovirus Type 1, 2 and 3|Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2701229|NCT01235949|Secondary|Antibody Titers Against Poliovirus Type 1, 2 and 3|Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.|One month after primary immunization (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2701230|NCT01235949|Secondary|Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)|Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2701305|NCT01235689|Secondary|Number of Crohn's Disease-related Hospitalizations After Randomization|Any hospitalization with an overnight stay in hospital/clinic related to Crohn's disease.|From Randomization through 48 weeks after Randomization|All randomized participants|||hospitalizations|||Number
2701395|NCT01235338|Secondary|Diastolic Blood Pressure||Baseline and up to 39 days|SAS|||mmHg||Standard Deviation|Mean
2701231|NCT01235949|Secondary|Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)|Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.|One month after primary immunization (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2701232|NCT01235949|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen|Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2701233|NCT01235949|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)|Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.|One month after primary immunization (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2701234|NCT01235949|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)|Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701235|NCT01235949|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)|Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.|One month after primary immunization (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701236|NCT01235949|Secondary|Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids|Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2701237|NCT01235949|Secondary|Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids|Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.|One month after primary immunization (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2701238|NCT01235949|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701239|NCT01235949|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|"OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value 99999.9 has been entered when value to be entered in the system was greater than (>) 1.0 E10."|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2701240|NCT01235949|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.|One month after primary immunization (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results or antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2701377|NCT01235403|Primary|Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study|Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study (up to 24 - 28 weeks)|Safety Set|||subjects|||Number
2701241|NCT01235949|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|Prior to (Month 9) and one month after booster vaccination (Month 10)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2701242|NCT01235949|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31-days (Day 0-30) following booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.|||Subjects|||Number
2701243|NCT01235949|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31-days (Day 0-30) following each primary vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.|||Participants|||Count of Participants
2701244|NCT01235949|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.|During the entire study period (Month 0 to 10)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one vaccine dose.|||Participants|||Count of Participants
2701245|NCT01235949|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 4-day (Days 0-3) period following booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.|||Participants|||Count of Participants
2701246|NCT01235949|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.|||Participants|||Count of Participants
2701247|NCT01235949|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).|Within the 4-day (Days 0-3) period following booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.|||Participants|||Count of Participants
2701248|NCT01235949|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).|Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.|||Participants|||Count of Participants
2701249|NCT01235949|Secondary|Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.|One month after primary immunization (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2701250|NCT01235949|Primary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.|One month after primary immunization (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701251|NCT01235949|Primary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.|One month after primary immunization (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2701252|NCT01235949|Primary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off|Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).|One month after primary immunization (At Month 3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2701253|NCT01235910|Secondary|Blood Pressure|The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any blood pressure for this study.|2 weeks||||mmHg|||Number
2701254|NCT01235910|Secondary|Aliskiren Plasma Concentrations|"Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance~The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any PK (e.g.(AUCs) for this study."|2 weeks||||ng*h/ml/mg|||Number
2701255|NCT01235910|Primary|Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)|The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.|7 days, 14 days, 30 days (End of Study)||||ng*h/ml/mg|||Number
2701256|NCT01235897|Secondary|Best Disease Response by Response Evaluation Criteria in Solid Tumor (RECIST), Version 1.1|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufﬁcient shrinkage to qualify for PR nor sufﬁcient increase to qualify for PD, taking as reference the smallest sum diameters while on study~Non-PR/Non-PD: clinical response of chest wall disease not evaluable by RECIST"|60 days after dose inititation|Analysis included all patients receiving at least 8 weeks of study therapy|||participants|||Number
2701257|NCT01235897|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of MK-2206 Administered Weekly in Combination With Weekly Paclitaxel 80 mg/m^2 and Trastuzumab 2 mg/m^2|The MTD was defined as the dose level resulting in 3 or fewer DLTs in 11 patients, per the modified toxicity probability interval (TPI) method (Ji Y, Li Y, Nebiyou Bekele B: Dose-ﬁnding in phase I clinical trials based on toxicity probability intervals. Clin Trials 4:235-244, 2007), and confirmed in 4 additional patients. Based on interim toxicity data from other studies, the dose was not escalated beyond 135 mg weekly.|30 days from initiation of dose|Sixteen participants completed at least one cycle of therapy and were evaluable for DLT per protocol. Patients were assessed for DLT during the first 4-week cycle.|||mg|||Number
2701258|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.|||mg/dL||Standard Deviation|Mean
2701259|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.|||mU/L||Standard Deviation|Mean
2701260|NCT01235741|Primary|Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).|Baseline to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.|||mg/dL||Standard Deviation|Mean
2701261|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement.|||beats/min||Standard Deviation|Mean
2701262|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).|Baseline to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up.|||mmHg||Standard Deviation|Mean
2701263|NCT01235741|Primary|Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L; bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.|||participants|||Number
2701264|NCT01235741|Primary|Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large.|Screening to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively.|||participants|||Number
2701265|NCT01235741|Primary|Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin|In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.|Baseline to Month 6 Follow-Up||||participants|||Number
2701266|NCT01235741|Primary|Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population|Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.|Week 1 to Month 6 Follow-Up|All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28.|||participants|||Number
2701267|NCT01235741|Primary|Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population|Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).|Baseline to Month 6 Follow Up|All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively.|||ng/mL||Standard Deviation|Mean
2701268|NCT01235741|Primary|Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population|Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.|Day 1 up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment.|||participants|||Number
2701269|NCT01235741|Secondary|Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively.|||percentage of change in weight||Standard Deviation|Mean
2701270|NCT01235728|Secondary|Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients|Plasma samples were collected at 12 hours post-dose on Days 8, 15, 22, and 28 to evaluate the mean maximum plasma concentration at trough of MK-0873.|Day 8, 15, 22, 29|The population consisted of all participants that received treatment, had no major protocol violations, and had MK-0873 plasma trough values available for the Day 8, 15, 22, and 28 treatment.|||nM||Standard Deviation|Mean
2701271|NCT01235728|Secondary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29|||Percent Change|Lesions|95% Confidence Interval|Least Squares Mean
2701272|NCT01235728|Primary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29.|||Percent Change|Lesions|95% Confidence Interval|Least Squares Mean
2701273|NCT01235715|Secondary|Visual Analog Pain Scale (At Night) At 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.|6 weeks postoperatively||||units on a scale||Standard Deviation|Mean
2701274|NCT01235715|Secondary|Visual Analog Pain Scale (During Therapy) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.|6 weeks postoperatively||||units on a scale||Standard Deviation|Mean
2701275|NCT01235715|Secondary|Visual Analog Pain Scale (During Activity) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.|||units on a scale||Standard Deviation|Mean
2701276|NCT01235715|Secondary|Visual Analog Pain Scale (at Rest) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.|||units on a scale||Standard Deviation|Mean
2701277|NCT01235715|Secondary|Range of Motion at 6 Weeks|A measurement of the degrees of motion of the operated knee six weeks after surgery.|6 weeks postoperatively|Patients whose range of motion at 6-week followup appointment was taken were included in analysis.|||degrees||Standard Deviation|Mean
2701278|NCT01235715|Primary|Units of Homologous Transfusion Over the Course of the Hospital Stay|Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|three days postoperatively|All patients who completed the study were included in analysis.|||units||Standard Deviation|Median
2701279|NCT01235715|Primary|Number of Autologous Transfusion Units Over the Course of the Hospital Stay|Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|perioperatively||||units||Standard Error|Mean
2701280|NCT01235715|Primary|Drain Output|A measurement of the amount of blood drained from the knee.|24 hours post-operatively|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||mL||Standard Error|Mean
2701281|NCT01235715|Primary|Change in Hematocrit on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||percentage of red blood cell||Standard Deviation|Mean
2701282|NCT01235715|Primary|Change in Hemoglobin on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
2701283|NCT01235715|Primary|Change in Hematocrit on Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||percentage of red blood cell||Standard Deviation|Mean
2701284|NCT01235715|Primary|Change in Hemoglobin On Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
2701285|NCT01235715|Primary|Change in Hematocrit on Day 0 Compared to Preoperatively||preoperatively and day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||percentage of red blood cell||Standard Error|Mean
2701286|NCT01235715|Secondary|Visual Analog Pain Scale on Day 3|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.|3 days postoperatively||||points on VAS scale||Standard Error|Mean
2701287|NCT01235715|Secondary|Range of Motion on Day 3|A measurement of the degrees of motion of the operated knee three days after surgery.|3 days postoperatively||||degrees||Standard Error|Mean
2701288|NCT01235715|Secondary|Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively|The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.|preoperatively and two days after surgery|All patients who completed the study were included in analysis.|||ratio||Standard Deviation|Mean
2701289|NCT01235715|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and on the day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
2701290|NCT01235689|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores|"The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component summary (PCS) score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. The mental component summary (MCS) score summarizes the subscales vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement."|Baseline and 48 weeks after Randomization|Randomized participants with Baseline and at least one post-baseline value; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
2701291|NCT01235689|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, from 0 (not at all) to 4 (very much). The FACIT-Fatigue score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from Baseline score indicates an improvement.~."|Baseline and 48 weeks after Randomization|Randomized participants with Baseline and at least 1 post-baseline value; last observation carried forward imputation was used|||units on a scale||Standard Deviation|Mean
2701292|NCT01235689|Secondary|Change From Baseline in Patient Health Questionnaire - 9 (PHQ9)|The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression. A negative change from Baseline score indicates improvement.|Baseline and 48 weeks after Randomization|Randomized participants with Baseline and at least one post-baseline value; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
2701293|NCT01235689|Secondary|Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD)|"The WPAI:CD questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions.~Work time missed was defined as the percentage of time absent from work due to Crohn's disease in the past week.~Impairment while working is the participant's assessment of the degree to which Crohn's disease affected productivity while working in the past 7 days.~Total work productivity impairment takes into account both hours missed due to Crohn's disease symptoms and the patient's assessment of the degree to which Crohn's disease affected their productivity while working.~Total activity impairment is the percent impairment of non-work related activities due to Crohn's disease.~WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement."|Baseline and 48 weeks after Randomization|Randomized participants with baseline and at least one post-baseline value; last observation carried forward imputation was used. The first 3 scores were only calculated for participants who were employed.|||percent impairment||Standard Deviation|Mean
2701294|NCT01235689|Secondary|Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score|The IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease, feeling in general, and mood. Each question is answered on a scale from 1 (all of the time) to 7 ( none of the time); the total score ranges from 7 (worst) to 224 (best). A positive change from baseline indicates improvement.|Baseline and 48 weeks after Randomization|Randomized participants with baseline and at least one post-baseline value; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
2701295|NCT01235689|Secondary|Total Dose of Prednisone|The total dose of prednisone each participant received during both the run-in phase and post-randomization treatment phase.|From Baseline through 48 weeks after Randomization|Participants who received prednisone|||mg||Standard Deviation|Mean
2701296|NCT01235689|Secondary|Change in Fecal Calprotectin From Baseline to 48 Weeks After Randomization|"Stool samples were analyzed by a central laboratory for fecal calprotectin qualitative measurement (< 250 or ≥ 250 μg/g). Results are reported for participants in each category at Baseline and 48 weeks after Randomization.~Participants with missing data 48 weeks after Randomization were counted as having fecal calprotectin ≥ 250µg/g."|Baseline and 48 weeks after Randomization|Randomized participants with Baseline data; non-responder imputation was used.|||Participants|||Count of Participants
2701297|NCT01235689|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time|High sensitivity C-reactive protein was analyzed by a central laboratory.|Baseline and 8 weeks during the prednisone run-in, and 11, 23, 35, and 48 weeks after Randomization.|Randomized participants; last observation carried forward imputation was used.|||mg/L||Standard Deviation|Mean
2701298|NCT01235689|Secondary|Change in Crohn's Disease Behavior According to Montreal Classification|"Participants' Crohn's Disease was classified according to the Montreal Classification which classifies CD according to its predominant phenotypic elements (age at diagnosis, location, and disease behavior) based on the results of clinical examination and endoscopy.~Disease behavior was classified according to the following:~B1 = non-stricturing, non-penetrating; B2 = structuring; B3 = penetrating; P = perianal disease modifier.~The change in Montreal Classification is presented in three categories: no change, deterioration, and improvement. Deterioration was defined as an increase in behavior index between 1 and 3, or development of perianal disease. Participants with missing data at Week 48 were classified as deterioration."|From Baseline to 48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||Participants|||Count of Participants
2701299|NCT01235689|Secondary|Number of Crohn's Disease-related Hospitalizations Due to Emergency|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department.|From Randomization through 48 weeks after Randomization|All randomized participants|||emergency hospitalizations|||Number
2701396|NCT01235338|Secondary|Systolic Blood Pressure||Baseline and up to 39 days|Safety Analysis Set (SAS) defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2701306|NCT01235689|Secondary|Number of Major Crohn's Disease-related Surgeries After Randomization|"Major Crohn's disease-related intra-abdominal surgery included:~bowel resection~ostomy~by-pass~strictureplasty~drainage of abdominal or pelvic abscess (surgical drainage or percutaneous drainage by interventional radiology).~The following were excluded:~debridement~exploration laparotomy~abdominal surgery for other reason~perineal related surgery~abscess drainage~placement of setons~fistulotomy~Total parental nutrition (TPN) use"|From Randomization through 48 weeks after Randomization|All randomized participants|||surgeries|||Number
2701307|NCT01235689|Secondary|Time to Crohn's Disease-related Hospitalization or Hospitalization Due to Adverse Event Relating to Study Medication|Crohn's disease-related hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic for reasons related to Crohn's disease (CD). Hospitalization for adverse events relating to study medication, i.e., prednisone, azathioprine or adalimumab, were according to Investigator's clinical judgment.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
2701308|NCT01235689|Secondary|Time to All-cause Hospitalization|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
2701309|NCT01235689|Secondary|Percentage of Participants in Steroid-free Remission Over Time|"Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders."|11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.|Randomized participants; non-responder imputation was used. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment.|||percentage of participants|||Number
2701310|NCT01235689|Secondary|Percentage of Participants in Clinical Remission Over Time|"Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders."|Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.|Randomized participants; non-responder imputation was used. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment.|||percentage of participants|||Number
2701311|NCT01235689|Secondary|Time to Steroid-free Remission|Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
2701312|NCT01235689|Secondary|Time to Clinical Remission|Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI scores generally range from 0 to 600 where higher scores indicate more severe disease.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
2701313|NCT01235689|Secondary|Time to Crohn's Disease Flare|Time to Crohn's disease flare, where flare is defined as an increase in CDAI ≥ 70 points compared to Week 8 or Early Randomization CDAI, and a CDAI > 220.|From Randomization to 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
2701314|NCT01235689|Secondary|Change From Baseline in CDAI Over Time|The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from Baseline indicates improvement.|Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.|Randomized participants with non-missing data at each time point. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment.|||units on a scale||Standard Deviation|Mean
2701315|NCT01235689|Secondary|Change From Baseline in CDEIS at 48 Weeks After Randomization|CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. A negative change from Baseline indicates improvement.|Baseline and 48 weeks after Randomization|Randomized participants with non-missing data at Baseline and 48 weeks after Randomization.|||units on a scale||Standard Deviation|Mean
2701378|NCT01235403|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study|Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study ( up to 24 - 28 weeks)|Safety Set|||subjects|||Number
2701316|NCT01235689|Secondary|Percentage of Participants With Endoscopic Response 48 Weeks After Randomization|"Endoscopic response was defined as a decrease CDEIS > 5 points. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
2701317|NCT01235689|Secondary|Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization|"Complete mucosal healing was defined as CDEIS = 0. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
2701318|NCT01235689|Secondary|Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization|"Percentage of participants with mucosal healing (defined as CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization. The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
2701319|NCT01235689|Secondary|Percentage of Participants With Mucosal Healing 48 Weeks After Randomization|"Percentage of participants with mucosal healing (defined as a CDEIS < 4) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
2701320|NCT01235689|Secondary|Percentage of Participants in Biologic Remission 48 Weeks After Randomization|"Biologic remission was defined as high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, fecal Calprotectin < 250 μg/g, and CDEIS < 4 at 48 weeks after randomization.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
2701321|NCT01235689|Secondary|Percentage of Participants in Deep Remission 48 Weeks After Randomization|"Deep remission was defined as CDAI < 150, discontinuation from steroids for at least 8 weeks, absence of draining fistula, CDEIS < 4 and no deep ulcerations.~CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
2701322|NCT01235689|Primary|Percentage of Participants With Mucosal Healing and No Deep Ulcerations|"Percentage of participants with mucosal healing (defined as Crohn's disease endoscopy Index of severity [CDEIS] < 4) and no deep ulcerations on ileocolonoscopy (defined as the absence of all deep ulcerations in all segments explored in CDEIS) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; Participants with missing CDEIS values from endoscopies performed 48 weeks after randomization were imputed as non-responders.|||percentage of participants|||Number
2701334|NCT01235598|Secondary|Change From Baseline to Week 16 in Tender Joint Count (TJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated Not tender; Yes indicated a positive tenderness response that was defined as a positive response to questioning (tender), spontaneous response elicited (tender and winced) or withdrawal by subject on examination (tender, winced, and withdrew). If there were missing observations in the TJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. TJC ranges from 0 to 28 with 0 indicating no tender joints and 28 indicating tenderness in all joints. A negative value in TJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2701323|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 2 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.~A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2701324|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 1 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.~A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2701325|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Changes in Hand Bone Mineral Density as Measured by Digital XRay (DXR) at Week 16|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with increases in bone mineral density at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
2701326|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Disease Activity Score-28 (DAS28 (CRP)) Response at Week 16|"The DAS28(CRP) was calculated using the tender joint count (TJC) and swollen joint count (SJC), C-Reactive Protein (CRP in mg/L) and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm).~A positive correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with reductions in DAS28(CRP) at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
2701327|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 70 % Criteria (ACR70) at Week 16|"Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR70 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
2701335|NCT01235598|Secondary|Change From Baseline to Week 16 in Bone Mineral Density as Measured by Digital XRay (DXR)|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.~A positive value in Bone Mineral Density change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||g/cm^2||Standard Deviation|Mean
2701379|NCT01235377|Secondary|Factors Associated With Prescribing Patterns|factors (barriers and facilitators) associated with prescribing according to the Cluster Designation|nine months|||||||
2701328|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 50 % Criteria (ACR50) at Week 16|"Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR50 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
2701329|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 20 % Criteria (ACR20) at Week 16|"Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR20 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
2701330|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.~Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28(CRP) > 5.1 and decrease from Baseline > 1.2~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with better EULAR responses."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
2701331|NCT01235598|Secondary|C-Reactive Protein (CRP) Ratio to Baseline at Week 16|"The C-Reactive Protein (CRP) is considered a marker of inflammation in subjects with Rheumatoid Arthritis.~A ratio to Baseline < 1 indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2701332|NCT01235598|Secondary|Change From Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject reported questionnaire that provides an assessment of the impact of the disease and its treatment on physical function. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question the level of difficulty is scored from 0 to 3 where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do. A total score is computed from the item scores using the scoring rules provided by the author (Fries, 1980). The total score ranges from 0 to 3 with lower scores meaning lower disability. A negative value in HAQ-DI change from Baseline indicates an improvement.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||scores on a scale||Standard Deviation|Mean
2701333|NCT01235598|Secondary|Change From Baseline to Week 16 in Swollen Joint Count (SJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated None swelling response and Yes indicated that there was a detectable synovial thickening with or without loss of bony contours, or bulging synovial proliferation with or without cystic characteristics. If there were missing observations in the SJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. SJC ranges from 0 to 28 with 0 indicating no swollen joints and 28 indicating swelling in all joints. A negative value in SJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2701362|NCT01235507|Secondary|CRP Levels|CRP is a marker of acute phase inflammation and is measured in mg/L. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mg/L||Standard Deviation|Mean
2701363|NCT01235507|Secondary|Participant's Global Assessment of Pain|Participant's global assessment of pain was performed using a 100 mm VAS ranging from no pain (0) at the left edge to unbearable pain (100) at the right edge. The distance in mm from the left edge of the scale was measured. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm||Standard Deviation|Mean
2701336|NCT01235598|Secondary|Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 16|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||percentage of subjects|||Number
2701337|NCT01235598|Secondary|Change From Baseline to Week 16 in the Disease Activity Score-28 (C-Reactive Protein) (DAS28 (CRP)) Response|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. A negative value in DAS28[CRP] change from Baseline indicates an improvement from Baseline.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2701338|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Criteria (ACR70) at Week 16|Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
2701339|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Criteria (ACR50) at Week 16|Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
2701340|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Criteria (ACR20) at Week 16|Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
2701341|NCT01235598|Secondary|Percentage of Subjects Achieving a Good European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.~Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28(CRP) > 5.1 and decrease from Baseline > 1.2"|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
2701342|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Number of Voxels (Nvox) With Plateau and Washout Pattern|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in Nvox change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||voxels||Standard Deviation|Mean
2701380|NCT01235377|Primary|Prescription Rates|rates of provider prescribing of the Cluster Designated drug|nine months|providers prescribing a thiazide at least once in the study period|||% new thiazide prescriptions||Inter-Quartile Range|Median
2701343|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Maximal Enhancement (ME)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in ME change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||percent change over pre-contrast||Standard Deviation|Mean
2701344|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Initiation Rate of Enhancement (IRE)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in IRE change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||percent per second||Standard Deviation|Mean
2701345|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
2701346|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
2701347|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 4|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
2701348|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 8|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
2701349|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
2701350|NCT01235546|Other Pre-specified|Infant Pyloric Stenosis|Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation|up to 3 months after birth||||Participants|||Count of Participants
2701351|NCT01235546|Other Pre-specified|Neonatal Serious Adverse Events|Composite for all neonatal serious adverse events|Up to 3 months after birth||||Participants|||Count of Participants
2701352|NCT01235546|Other Pre-specified|Maternal Serious Adverse Events|All maternal serious adverse events|Up to 6 weeks after delivery||||Participants|||Count of Participants
2701353|NCT01235546|Other Pre-specified|Maternal Postpartum Antibiotic Use|Maternal postpartum use of antibiotics|Up to 6 weeks after delivery||||Participants|||Count of Participants
2701354|NCT01235546|Other Pre-specified|Maternal Postpartum Readmission or Unscheduled Visit|Maternal postpartum unscheduled visit or readmission to the hospital|Up to 6 weeks after delivery||||Participants|||Count of Participants
2701355|NCT01235546|Other Pre-specified|Maternal Fever||Up to 6 weeks after delivery|Postpartum Fever|||Participants|||Count of Participants
2701356|NCT01235546|Other Pre-specified|Neonatal Readmission||Up to 3 months after birth|Hospitalization after discharge|||Participants|||Count of Participants
2701357|NCT01235546|Other Pre-specified|Neonatal Intensive Care Unit (NICU) Admission|Neonates who are admitted to the NICU due to morbidities diagnosed from birth and up to three months of life. Morbidities as defined in the Neonatal morbidities outcome measure.|Up to 3 months after birth||||Participants|||Count of Participants
2701358|NCT01235546|Other Pre-specified|Neonatal Morbidities (Listed Below)|morbidities include: death, Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Periventricular Leukomalacia (PVL) suspected or proven sepsis, Necrotizing Enterocolitis (NEC) Intraventricular Hemorrhage (IVH) and systemic inflammatory response syndrome|Up to 3 months after birth||||Participants|||Count of Participants
2701359|NCT01235546|Primary|Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)|Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C [100.4°F]), abdominal pain, uterine tenderness, or purulent drainage from the uterus. Wound infection was defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, or breakdown alone in the absence of the preceding signs did not constitute infection.|Up to 6 weeks after delivery|The specific characteristics related to the cesarean delivery, including indications for cesarean delivery, receipt of standard prophylaxis, timing of receipt of study medication, and type of surgical skin preparation, were similar in the two groups.|||Participants|||Count of Participants
2701360|NCT01235507|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.|Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24|Safety Analysis Population: All participants enrolled in the study who received at least 1 dose of study medication and had at least 1 post-baseline assessment of safety (such as laboratory data, vital signs, or AEs) were included.|||percentage of participants|||Number
2701361|NCT01235507|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour). A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm/hour||Standard Deviation|Mean
2701397|NCT01235338|Primary|Cmax of Venlafaxine Hydrochloride|Venlafaxine Hydrochloride is the active ingredient of Effexor XR|Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
2701364|NCT01235507|Secondary|Participant's Global Assessment of Disease Activity|Participant's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm||Standard Deviation|Mean
2701365|NCT01235507|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm||Standard Deviation|Mean
2701366|NCT01235507|Secondary|Swollen and Tender Joint Counts|66 and 68 joints were assessed by the physician for tenderness or swelling respectively. The joints were counted as tender/not tender (tender=1; not tender=0) and swollen/not swollen (swollen=1; not swollen=0) and scored. The scores ranged from 0 to 66 for TJC and 0 to 68 for SJC. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point|||Joints||Standard Deviation|Mean
2701367|NCT01235507|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28|"DAS28 was calculated using the 28 joints count, the CRP and PtGA of disease activity. The following formula was used to determine DAS28.~DAS28 = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100-mm VAS).~The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Participants were considered to have low disease activity when DAS28 was less than or equal to (≤) 3.2 and in clinical remission when DAS28 scores were less than (<) 2.6"|Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point|||percentage of participants|||Number
2701368|NCT01235507|Secondary|Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit|"DAS28 was calculated using the 28 joints count, the C-reactive protein levels (CRP) and participant's global assessment (PtGA) of disease activity. The following formula was used to determine DAS28.~DAS28 (equals) = 0.56 × (square root of) √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100- millimeter [mm] visual analog scale [ VAS]).~The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity."|Baseline, Weeks 8, 16 and 24|ITT Population; number (n) = number of participants analyzed for the given parameter at the specified time point|||units on a scale||Standard Deviation|Mean
2701369|NCT01235442|Secondary|sPGA (0,1) at Week 24|The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2701370|NCT01235442|Secondary|PASI 75 at Week 24|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2701371|NCT01235442|Secondary|Percent PASI Improvement From Baseline at Week 12|The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of Improvement in PASI score||Standard Deviation|Mean
2701372|NCT01235442|Secondary|Patient Satisfaction at Week 12|"Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from very satisfied to very dissatisfied."|Week 12|PRO analysis set, including all subjects randomized and also complete the baseline and at least 1 of the post-baseline PRO assessment with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2701373|NCT01235442|Secondary|PASI 90 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2701374|NCT01235442|Secondary|sPGA (0,1) at Week 12|The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2701375|NCT01235442|Primary|PASI 75 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2701399|NCT01235338|Primary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|Pharmacokinetic Analysis Set (PAS) defined as all subjects who took a t least 1 dose of investigational product and had at least 1 post-dose safety assessment and who had no major deviations related to investigational product intake (e.g. vomiting) and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/ml||Standard Deviation|Mean
2701400|NCT01235234|Secondary|Ocular Surface Disease Index|Change from Baseline in Ocular Surface Disease Indexat Week 24|24 weeks|||||||
2701401|NCT01235234|Secondary|Increase in Schirmer Test Tearing by >9mm Over Baseline|Proportion of subjects with ST wetting increase over Baseline of ≥10 mm with or without anesthesia in either eye at Week 24|24 weeks|||||||
2701402|NCT01235234|Primary|Nature and Frequency of Adverse Events|The primary efficacy comparison with respect to the rates of complete clearing of corneal staining at Week 24 was performed using a 2-sided test at level 0.025 to adjust for the comparison of 2 doses of CF101 to placebo. All between-treatment comparisons with respect to all secondary efficacy endpoints were performed using 2-sided tests at level 0.025. Between-treatment comparisons with respect to ancillary efficacy endpoints were performed using 2-sided tests at level 0.05. The primary comparison, as well as the comparisons with respect to the proportion of subjects with complete central corneal clearing (i.e., central corneal FS score=0) in the target eye and the proportion of subjects with ST ≥10 mm with or without anesthesia in either eye, was performed using the Cochran-Mantel-Haenszel test, stratified by duration of symptoms at Baseline (≤5 years or>5 years) and disease severity at Baseline (ST1-3or4-6 mm/5 minutes without anesthesia).|24 weeks|||||||
2701403|NCT01235234|Primary|Efficacy by Proportion of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24|Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale|24 weeks||||participants|||Number
2701404|NCT01235195|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||hours||Standard Deviation|Mean
2701405|NCT01235195|Secondary|Residual Area Under the Concentration Time Curve [AUC(Res%)]|AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2701406|NCT01235195|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||ng*h/mL||Standard Deviation|Mean
2701407|NCT01235195|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||hours||Full Range|Median
2701408|NCT01235195|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2701409|NCT01235195|Primary|Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]|AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.|||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2701410|NCT01234922|Secondary|Change in Ang II, VEGF, PlGF, and ACE Levels||1 week|Data were not analyzed due to insufficient accrual to the study and lack of statistical power.||||||
2701411|NCT01234922|Primary|Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter||7 days post-baseline||||Picogram/milliliter||Standard Deviation|Mean
2701412|NCT01234883|Primary|Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)|The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.|Day 1 (4 Hours after start of IV)|The mITT population is all subjects with Baseline bicarbonate value ≤ 22 mmol/L. The mITT population was used for efficacy evaluation. The AT analysis set was defined as all subjects who received at least 5 mL of study treatment and were classified according to actual treatment received. AT population was used for AE analysis.|||mmol/L||Standard Deviation|Mean
2701413|NCT01234870|Secondary|Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol|Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.|14 days||||occurances of adverse events|||Number
2701430|NCT01234714|Primary|Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)|"Liver fat content, measured by MRI, uses the in-phase/out-of-phase imaging calculated in terms of fat signal fraction (FSF).~The Clavien-Dindo Classification of Surgical Complications:~Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient"|December 2010|According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/|||Percentage of liver fat content||Inter-Quartile Range|Median
2701414|NCT01234870|Primary|Magnetic Resonance Image Quality Rating|The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality|Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.||||units on a likert scale||Standard Deviation|Mean
2701415|NCT01234831|Secondary|Rate of Recolonization or Documented Infection With MRSA|Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection. Subjects in the Intervention Arm of the study who had documented clearance of colonization and met criteria for discontinuation of contract precautions, and had CP discontinued by staff (N=69) were included. Subjects who had a visit at MGH through 12/31/2012 during which a microbiology sample was obtained and MRSA was recovered (clinical or surveillance) were included.|2 years|We reviewed the data on the 69 subjects who were enrolled in the intervention arm of the trial who were cleared of colonization based on the study intervention.|||Participants|||Count of Participants
2701416|NCT01234831|Secondary|Specificity of First PCR Assay.|Specificity of the first PCR assay for subjects enrolled in active arm of trial.|1 year||||percentage of true negatives||95% Confidence Interval|Number
2701417|NCT01234831|Secondary|Sensitivity of First PCR Assay|Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.|1 year||||percentage of true positives||95% Confidence Interval|Number
2701418|NCT01234831|Secondary|Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay|This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol.|1 year|Number of participants in the Active Screening arm who had completed the 3-swab protocol.|||participants|||Number
2701419|NCT01234831|Primary|Discontinuation of Contact Precautions in Both Trial Arms|"Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, Contact Precautions are discontinued refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use."|1 year|Analysis was performed on patients in both the Active Screening arm and Passive Screening arm who had completed the 3-swab protocol and all 3 swabs were negative.|||percentage of MRSA CP discontinued|||Number
2701420|NCT01234831|Primary|Completion of Screening Protocol in Both Trial Arms|Rate at which subjects in both trial arms complete the 3-swab protocol.|1 year|Participants in both the Active Screening arm and Passive Screening arm who completed the 3-swab protocol.|||percentage of subjects completed 3 swabs|||Number
2701421|NCT01234831|Primary|Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays|This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.|1 year|Only patients randomized to the Active Screening arm who had 3 pairs of completed nasal swabs could be analyzed for this outcome measure which is the negative predictive value of the first PCR sample compared to three culture samples for subjects with a history of prior MRSA infection or colonization.|||percentage of participants||95% Confidence Interval|Number
2701422|NCT01234766|Primary|Number of Participants With Complete Response at 3 Years|The primary endpoint is complete response (CR) rate. Historical complete response (CR) rate has been 35%. This rate will be considered as the null hypothesis.|3 years||||Participants|||Count of Participants
2701423|NCT01234714|Secondary|Type of Post-operative Complications|There are several different types of post-operative complications associated with liver surgery, such as liver failure, multi-organ failure, bleeding, bile leak, and sepsis.|December 2010|||||||
2701424|NCT01234714|Secondary|Cost|The total in-hospital costs were calculated for each patient in Euros.|December 2010|According to MRI|||Euros||Standard Deviation|Mean
2701425|NCT01234714|Secondary|Hospital Stay|The patient hospital stay was calculated according to the total number of days the patient was hospitalized.|December 2010|According to MRI|||days||Inter-Quartile Range|Median
2701426|NCT01234714|Secondary|Intensive Care Unit (ICU) Stay|The Intensive Care Unit (ICU) stay was calculated according to the total number of days the patients were managed in the ICU. This included also multiple ICU admissions.|December 2010|According to MRI|||days||Inter-Quartile Range|Median
2701427|NCT01234714|Secondary|Operative Time|The operation duration was measured according to the total minutes from the beginning of the operation until the end.|December 2010|According to MRI|||min||Inter-Quartile Range|Median
2701428|NCT01234714|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.|December 2010|According to MRI|||ml||Inter-Quartile Range|Median
2701429|NCT01234714|Secondary|Post-operative Alanine Transaminase (ALT) Levels|Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.|December 2010|According to the MRI liver fat content measurement.|||Units/liter||Inter-Quartile Range|Median
2701431|NCT01234675|Secondary|Brief Pain Inventory (BPI) Mean Interference Score|The score is derived from the BPI scale and measures the effect of pain on functioning in the past 24 hour. It is the average score of 7 items interfering with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Score ranges from 0-10 with higher scores reflecting greater interference.|4-Week treatment with milnacipran and placebo||||score on a scale||Standard Error|Mean
2701432|NCT01234675|Secondary|Brief Pain Inventory (BPI) Mean Severity Score|"The score is derived from the BPI scale and measures pain intensity in the past 24 hour. The pain severity score is derived as the average score of 4 pain items assessing pain at its worst, least, average and now and ranges from 0-10 with higher scores reflecting greater pain"|4-Week treatment with milnacipran and placebo||||score on a scale||Standard Error|Mean
2701433|NCT01234675|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score|The scale is composed of 10 items relating to fibromyalgia symptoms experienced in the past week. Score ranges from 0 to 100 with higher scores indicating a greater effect of fibromyalgia on a person's life.|4-Week treatment with milnacipran and placebo||||score on a scale||Standard Error|Mean
2701434|NCT01234675|Secondary|Fatigue Severity Scale (FSS) Total Score|The scale is a 9-item self-report of fatigue in the past week and scored on a 7-point scale with 1 = strongly disagree and 7 = strongly agree. Scores range from 9 to 63 with higher scores indicating higher fatigue severity. A total score greater or equal to 36 suggests fatigue.|4-Week treatment with milnacipran and placebo||||score on a scale||Standard Error|Mean
2701435|NCT01234675|Secondary|Sleep Quality Scale|"Sleep quality measure derived from daily sleep diary rating ranging from 0 (very poor) to 10 (excellent)"|4-Week treatment with milnacipran and placebo||||score on a scale||Standard Error|Mean
2701436|NCT01234675|Secondary|Sleep Problem Index 2, Medical Outcomes Study Sleep Scale (MOS-SS)|This is a subjective index derived from the medical outcomes study sleep scale (MOS-SS) scored on a 0-100 possible range with higher scores indicating more severe sleep disruption. The scale is a self-report instrument consisting of 12 items that assess perceived initiation and maintenance of sleep, respiratory problems during sleep, sleep duration, perceived adequacy of sleep and daytime somnolence.|4-Week treatment with milnacipran and placebo||||score on a scale||Standard Error|Mean
2701437|NCT01234675|Secondary|Slow Wave Sleep (SWS)|Time spent in stage 3 of non-rapid eye movement sleep and often referred to as deep sleep.|4-Week treatment with milnacipran and placebo||||percentage of total sleep time||Standard Error|Mean
2701438|NCT01234675|Secondary|Arousal Index (AI)|Number of arousals per hour of sleep|4-Week treatment with milnacipran and placebo||||arousals per hour||Standard Error|Mean
2701439|NCT01234675|Secondary|Total Sleep Time (TST)|Total sleep of all Rapid Eye Movement (REM) and Non- Rapid Eye Movement Sleep (NTREM) from lights out to lights on.|4-Week treatment with milnacipran and placebo||||minutes||Standard Error|Mean
2701440|NCT01234675|Secondary|Latency to Persistent Sleep Onset (LPS)|It is defined as time from lights out to the first consecutive 2 minutes of uninterrupted sleep.|4-Week treatment with milnacipran and placebo||||minutes||Standard Error|Mean
2701441|NCT01234675|Primary|Wake After Sleep Onset (WASO)|Wake time after defined sleep onset until lights on.|4-Week maintenance treatment with milnacipran and placebo||||minutes||Standard Error|Mean
2701442|NCT01234675|Primary|Sleep Efficiency (SE)|Percentage of time spent asleep while in bed|4-Week maintenance treatment with milnacipran and placebo||||percentage of total sleep time||Standard Error|Mean
2701443|NCT01234675|Primary|Number of Awakenings After Sleep Onset (NAASO)|Number of awakenings after defined sleep onset until lights on.|4-Week maintenance treatment with milnacipran and placebo|15 subjects completed the study|||Awakenings||Standard Error|Mean
2701444|NCT01234649|Secondary|Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio|ALT/AST ratio, used to assess liver function in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||ratio of ALT (U/L)/ AST (U/L)||Standard Deviation|Mean
2701445|NCT01234649|Secondary|Aspartate Aminotransferase (AST)|The hepatic marker, AST, associated with insulin resistance in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||U/L||Standard Deviation|Mean
2701446|NCT01234649|Secondary|Alanine Aminotransferase (ALT) Levels|Hepatic enzyme, ALT, associated with insulin resistance, in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||U/L||Standard Deviation|Mean
2701447|NCT01234649|Secondary|Diastolic Blood Pressure|DBP in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mmHg||Standard Deviation|Mean
2701448|NCT01234649|Secondary|Systolic Blood Pressure|SBP in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mmHg||Standard Deviation|Mean
2701449|NCT01234649|Secondary|Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)|TRG/HDL-Cholesterol levels in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||ratio of TRG (mg/dL)/HDL-C (mg/dl)||Standard Deviation|Mean
2701450|NCT01234649|Secondary|Triglyceride (TRG) Levels|TRG concentrations in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mg/dL||Standard Deviation|Mean
2701451|NCT01234649|Secondary|Low Density Lipoprotein Cholesterol (LDL-C) Levels|LDL-Cholesterol levels in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mg/dL||Standard Deviation|Mean
2701452|NCT01234649|Secondary|High Density Lipoprotein Cholesterol (HDL-C) Levels|HDL-C levels in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mg/dL||Standard Deviation|Mean
2701453|NCT01234649|Secondary|Total Cholesterol (CHOL) Levels|CHOL levels in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||mg/dL||Standard Deviation|Mean
2701454|NCT01234649|Secondary|Waist to Height Ratio (WHtR)|Waist circumference divided by height (measure of body fat distribution) in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||ratio of waist /height||Standard Deviation|Mean
2701455|NCT01234649|Secondary|Waist-to-Hip Ratio (WHR)|Waist circumference divided by hip circumference (a measure of central adiposity) in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||ratio of waist/hip circumference||Standard Deviation|Mean
2701456|NCT01234649|Secondary|Waist Circumference (WC)|Waist size (measure of truncal adiposity) with LIRA-MET compared to PL-MET|84 weeks of treatment||||centimeters||Standard Deviation|Mean
2701457|NCT01234649|Secondary|Body Mass Index (BMI)|BMI, a measure of total body adiposity, in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||weight (kg) /height (m) squared||Standard Deviation|Mean
2701458|NCT01234649|Secondary|Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)|Change in body weight from baseline to end o f study in LIRA-MET group compared with PL-MET group. The number was derived from final weight minus baseline and normalized to a percent.|Change from baseline (time 0) to study end (84 weeks)||||percent change in weight from baseline||Standard Error|Mean
2701466|NCT01234467|Secondary|Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab|The major grade 3 or higher adverse events were haematological toxicities. The results below include common haematological and non-haematological toxicities of grade 3 or higher. A complete record of all adverse events are reported in the adverse events section. National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 were used to assess toxicity.|Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of patients|||Number
2701467|NCT01234467|Secondary|Overall Survival|This represents the Kaplan-Meier estimates of median overall survival defined as the time from start of treatment until death as a result of any cause.|2 years with the median follow-up of 29 months|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||Months||95% Confidence Interval|Median
2701468|NCT01234467|Secondary|Estimate of Progression-Free Survival|Progression-free survival (PFS) will be summarized using the Kaplan-Meier method. PFS was defined as the time from the start of treatment until lymphoma progression or death as a result of any cause. Progression was defined by The International Harmonization Project for Response Criteria as any new lesion or increase by ≥50% of previously involved sites from nadir.|2 years with the median follow-up of 29 months|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||Months||95% Confidence Interval|Median
2701469|NCT01234467|Secondary|Partial Response Rate|The percentage of participants achieving a partial response (PR). PR is defined by The International Harmonization Project for Response Criteria as regression of measurable disease and no new sites.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of participants||95% Confidence Interval|Number
2701470|NCT01234467|Secondary|Overall Response Rate (ORR)|The ORR consists of the complete response rate + the partial response rate (percentage of participants achieving a complete or partial response). Complete response is defined by The International Harmonization Project for Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response is defined as regression of measurable disease and no new sites.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of participants|||Number
2701471|NCT01234467|Primary|Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria|Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of participants||95% Confidence Interval|Number
2701472|NCT01234402|Secondary|Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies||Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, Aall randomized participants who received at least one dose of study drug and had evaluable serum samples for antibody assessment.~For icrucumab, zero participants analyzed as antibody assessment data was not collected for Icrucumab."|||Participants|||Count of Participants
2701473|NCT01234402|Secondary|Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab|Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab.|Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples.~For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples."|||Liters||Geometric Coefficient of Variation|Geometric Mean
2701474|NCT01234402|Secondary|Clearance (Cl) of Ramucirumab or Icrucumab|Clearance (Cl) of Ramucirumab and Icrucumab.|Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples.~For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples."|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2701475|NCT01234402|Secondary|Terminal Half-life (t½) of Ramucirumab or Icrucumab|Terminal half-life (t½) of Ramucirumab and Icrucumab.|Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples.~For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples."|||Days||Full Range|Geometric Mean
2701476|NCT01234402|Secondary|Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab|Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab.|Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples.~For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples."|||microgram*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2701477|NCT01234402|Secondary|Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab|Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab.|Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples.~For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples."|||Micro gram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2701478|NCT01234402|Secondary|Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab||Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion|"For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples.~For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples."|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2701479|NCT01234402|Secondary|Number of Participants With Serious Adverse Events (SAEs)|"SAE was defined as any untoward medical occurrence that at any dose:~Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Up To 160 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2701480|NCT01234402|Secondary|Number of Participants With Adverse Events (AEs)|"Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Up To 160 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2701481|NCT01234402|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression.|From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks)|All randomized participants who received at least one dose of study drug and had CR/PR.|||weeks||95% Confidence Interval|Median
2701482|NCT01234402|Secondary|Percentage of Participants With Objective Response Rate (ORR)|The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression.|From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks)|All randomized participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2701483|NCT01234402|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.|From Date of Randomization until Death Due to Any Cause (Up To 160 weeks)|All randomized participants who received at least one dose of study drug; censored participants: Ramucirumab + Capecitabine = 21; Icrucumab + Capecitabine = 17; Capecitabine = 22 Participants were analyzed as per the randomization.|||Weeks||95% Confidence Interval|Median
2701484|NCT01234402|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.|From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)|All randomized participants who received at least one dose of study drug; Censored participants: Ramucirumab + Capecitabine = 12; Icrucumab + Capecitabine = 11; Capecitabine = 7|||Weeks||95% Confidence Interval|Median
2701485|NCT01234350|Secondary|All-cause of Mortality|A summary of IRs of all-cause mortality is presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||Events per 100 PYE|||Number
2701486|NCT01234350|Secondary|Changes in Testosterone Levels|Change from baseline in testosterone levels are presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||ng/mL||Full Range|Median
2701487|NCT01234350|Secondary|Long Term Evaluation of Clinical Evolution of Prostate Cancer|Change in prostate specific antigen (PSA) is presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||ng/mL||Full Range|Median
2701488|NCT01234350|Secondary|Number and Classification of New Adverse Drug Reactions (ADRs)|An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||New ADR|||Number
2701489|NCT01234350|Primary|Change in Serum Glucose|Change from baseline in serum glucose are presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||mmol/L||Full Range|Median
2701490|NCT01234350|Primary|Change in Hepatic Enzymes|Change from baseline in hepatic enzyme level (bilirubin) is presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||umol/L||Full Range|Median
2701491|NCT01234350|Primary|Change in Hepatic Enzymes|Change from baseline in hepatic enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase [ALP]) are presented.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||IU/L||Full Range|Median
2701492|NCT01234350|Primary|Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)|"IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE.~Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L"|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||Events per 100 PYE|||Number
2701493|NCT01234350|Primary|Incidence Rate of AESI: Decreased Bone Density|IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||Events per 100 PYE|||Number
2701494|NCT01234350|Primary|Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events|The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).|From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)|The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).|||Events per 100 PYE|||Number
2701495|NCT01234337|Other Pre-specified|Number of Participants With Treatment-emergent Grade 3 and 4 Laboratory Abnormalities|Hematological (anemia, hemoglobin, international normalized ratio [INR], lymphocyte, neutrophil, platelet, white blood cell [WBC]), biochemical (ALT [alanine aminotransferase], AST [aspartate aminotransferase], GGT [gamma-glutamyl-transferase], lipase, hypoalbuminemia, hypocalcemia, hyperglycemia, hyperuricemia) evaluations were done. Common terminology criteria for adverse events (CTCAE) version 4-Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization and CTCAE version 4-Grade 4: life-threatening consequences; urgent intervention were indicated.|From the start of study treatment up to 30 days after the last dose|Safety Analysis Set (SAF) was comprised of all randomized participants who received at least one dose of study medication (sorafenib, placebo or capecitabine). Participants were analyzed as treated.|||Participants|||Number
2701518|NCT01233921|Secondary|Changes in the Number of Naive CD4 T Cells in the Blood|Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin||||cells per microliter of blood||Standard Deviation|Mean
2701496|NCT01234337|Other Pre-specified|Area Under Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Capecitabine and 5-fluorouracil|AUC(0-tlast) is defined as AUC from time 0 to the last data point, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|PKS|||milligram*hour per liter||Geometric Coefficient of Variation|Geometric Mean
2701497|NCT01234337|Other Pre-specified|Maximum Observed Drug Concentration (Cmax) of Capecitabine and 5-fluorouracil|Maximum observed drug concentration, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|Pharmacokinetic Analysis Set (PKS) included all participants with a valid pharmacokinetic profile of capecitabine.|||milligram per liter||Geometric Coefficient of Variation|Geometric Mean
2701498|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D was a generic QoL preference based instrument and has been validated in the cancer populations. VAS was generated from 0 (worst imaginable health state) to 100 (best imaginable health state). This VAS score was referred to as the EQ-5D self-reported health status score. The results on ANCOVA of time-adjusted AUC were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2701499|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D was a generic Quality of life (QoL) based instrument validated in cancer populations. EQ-5D questionnaire contained a 5-item descriptive system of health states (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and visual analogue scale (VAS). A single HRQoL score ranging from -0.59 to 1 was generated from standard scoring algorithm developed by the EuroQoL was the EQ-5D index score, higher scores represent better health status. A change of at least 0.10 to 0.12 points was considered clinically meaningful. The results on the ANCOVA of time-adjusted AUC for the EQ-5D - Index Score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2701500|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy-Breast Symptom Index (8 Item) (FBSI-8)|The FBSI-8 was an 8-item questionnaire. Participants responded to each item using a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). A total scale score was calculated (range from 0 to 32), with higher scores indicating low symptomatology and reflecting a better Health-Related Quality of Life (HRQoL). The results on the analysis of covariance (ANCOVA) of time-adjusted area under curve (AUC) for the FBSI-8 score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, 31, 34, 37, and end of treatment (EOT, 21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2701501|NCT01234337|Secondary|Duration of Response (DOR) by Central Reader|DOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|Only responders in FAS were evaluated for this outcome measure.|||days||95% Confidence Interval|Median
2701502|NCT01234337|Secondary|Disease Control Rate (DCR) by Central Review|DCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS|||percentage (%) of participants||95% Confidence Interval|Number
2701503|NCT01234337|Secondary|Objective Response Rate (ORR) by Central Review|ORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS|||Percentage (%) of participants||95% Confidence Interval|Number
2701504|NCT01234337|Secondary|Time to Progression (TTP) by Central Review|TTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS|||days||95% Confidence Interval|Median
2701505|NCT01234337|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later|FAS|||days||95% Confidence Interval|Median
2701506|NCT01234337|Primary|Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1|PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years or until disease radiological progression|Full Analysis Set (FAS), also considered as Intent-to-treat (ITT) set, was defined as all randomized participants even if randomized but received no drug or if randomized and initially received incorrect drug prior to switching to correct study drug, these were included in FAS.|||days||95% Confidence Interval|Median
2701507|NCT01234207|Primary|Questionnaire Battery|Forced-choice Likert scale preference questionnaire|At study exit, after both Test and Control spectacles had been worn for 1 week each|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||percentage of participants|||Number
2701508|NCT01234207|Primary|Horizontal Extent of Undistorted Vision at Reading Distance|Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||cm||Standard Deviation|Mean
2701509|NCT01234207|Primary|30-degree Off-axis Distance Visual Acuity, Low Contrast Chart|Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
2701510|NCT01234207|Primary|30-degree Off-axis Distance Visual Acuity, High Contrast Chart|Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
2701511|NCT01234207|Primary|Visual Acuity, Low Contrast, Near Chart|Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
2701512|NCT01234207|Primary|Visual Acuity, High Contrast, Near Chart|Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
2701513|NCT01234207|Primary|Visual Acuity, Low Contrast, Distance Chart|Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
2701514|NCT01234207|Primary|Visual Acuity, High Contrast, Distance Chart|Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
2701519|NCT01233921|Primary|Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood|RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin||||cells per microliter of blood||Standard Deviation|Mean
2701520|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECGs were centrally evaluated. ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (≥)300 milliseconds (msec) or ≥25% increase when baseline is greater than (>)200 msec and ≥50% increase when baseline is less than or equal to (≤)200 msec; QRS interval ≥200 msec or ≥25%/50% increase from baseline; and QTcF ≥450 msec or ≥30 msec increase.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.|||participants|||Number
2701521|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.|||participants|||Number
2701522|NCT01233869|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2701523|NCT01233869|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2701524|NCT01233869|Secondary|Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25|The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.|Baseline and end of ITPV (Month 25)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout); n=the number of participants analyzed in the respective arms.|||units on a scale||Standard Deviation|Mean
2701525|NCT01233869|Secondary|Observed Accumulation Ratio (Rac) of Bosutinib|Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2701526|NCT01233869|Secondary|Terminal Elimination Half-Life (t1/2) of Bosutinib|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore t1/2 was not reported.||||||
2701527|NCT01233869|Secondary|Apparent Volume of Distribution (Vz/F) of Bosutinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore Vz/F was not reported.||||||
2701552|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 2|The variables recorded related to administered insulin in IU/day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||IU/day||Standard Deviation|Mean
2701528|NCT01233869|Secondary|Apparent Oral Clearance (CL/F) of Bosutinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2701529|NCT01233869|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib||Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2701530|NCT01233869|Secondary|Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib|Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2701531|NCT01233869|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.|||hours||Full Range|Median
2701532|NCT01233869|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2701533|NCT01233869|Secondary|Number of Participants With High Serum Creatinine (SCr) Levels|A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2701534|NCT01233869|Secondary|Number of Participants With High Blood Urea Nitrogen (BUN) Levels|A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2701535|NCT01233869|Secondary|Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days|ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
2701536|NCT01233869|Secondary|Time to First Occurrence of Proteinuria|Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
2701537|NCT01233869|Secondary|Time to First Occurrence of Gross Hematuria|Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
2701538|NCT01233869|Secondary|Time to First Occurrence or Worsening of Back and/or Flank Pain|The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
2701539|NCT01233869|Secondary|Time to First Occurrence or Worsening of Hypertension|The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
2701577|NCT01233284|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FVC was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
2701540|NCT01233869|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination|eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.|Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination|The mITT population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment; n=the number of participants analyzed at that time point in the respective arms.|||mL/min/1.73m^2||Standard Deviation|Mean
2701541|NCT01233869|Primary|Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25|TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).|Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])|The modified intent-to-treat (mITT) population included all participants who were randomized and received at least 2-weeks' worth of treatment and have at least 1 follow-up MRI assessment that was preceded by a 1-month washout of the study drug; n=the number of participants analyzed at that time point in the respective arms.|||centimeter cube (cm^3)||Standard Deviation|Mean
2701542|NCT01233817|Primary|Strength|Primary Outcome Measure was muscle strength. Strength was measured using a fixed myometry evaluation, quantitative muscle analysis (QMA). QMA utilizes a relative fixed point for the participant to exert effort. Each muscle of interest was tested using QMA.|12 weeks||||kilograms||95% Confidence Interval|Median
2701543|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 4|Number of participants with infectious complications is provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||participants|||Number
2701544|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 3|The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||number of new cases per 1000 days|||Number
2701545|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 2|Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||participants|||Number
2701546|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 1|Infectious complication incidence rate per 100 days of treatment are provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||percentage of patients with infection|||Number
2701547|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2|"This table shows the rates of:~Controls analysis on 80-150 mg/dL: optimal level of glycemia rate.~Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate.~Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||% of capillary glycemia measurements|||Number
2701548|NCT01233726|Primary|Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1|This table shows the number of capillary glycemia measurements|28 days post-admission||||number of capillary glycemia measurement|||Number
2701549|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 5|"The variables recorded related to Glycemic CV (%) are provided in this table:~Glycemic Coeficient of variation (%) after 28 days in ICU~Glycemic Coeficient of variation (%) after 7 days in ICU."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||percentage of Glycemic CV||Standard Deviation|Mean
2701550|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 4|The variables recorded related to the number of measurements per patient per day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||Measurements per patient/day||Standard Deviation|Mean
2701551|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 3|The variables recorded related to number of capillary glycemia measurements are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||Capillary glycemia measurements|||Number
2701952|NCT01230424|Secondary|Change in Time to Complete a Twenty-meter Walk.|Change in time (seconds) to complete a twenty-meter walk. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||seconds||95% Confidence Interval|Mean
2701553|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 1|The variables recorded related to glycemic control in mg/dL are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||mg/dL||Standard Deviation|Mean
2701554|NCT01233687|Secondary|Overall Survival (OS)|Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.|Up to 24 months (after the first evaluable patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||months||90% Confidence Interval|Median
2701555|NCT01233687|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Up to 24 months (after the first patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||months||90% Confidence Interval|Median
2701556|NCT01233687|Secondary|Objective Response Rate (ORR/Clinical Response)|Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Up to 6 months|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||percentage of patients||90% Confidence Interval|Number
2701557|NCT01233687|Primary|Disease Control Rate (DCR)|Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Six weeks from initiation of treatment with AMG 102 + Erlotinib|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||percentage of patients||90% Confidence Interval|Number
2701558|NCT01233687|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity|Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.|During first cycle of treatment (3 weeks)|In the absence of DLTs among the first 7 pts treated, AMG 102 + Erlotinib (150 mg) daily (3 weeks) was declared the RP2D.|||percentage of participants||90% Confidence Interval|Number
2701559|NCT01233609|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity|Mean change in best corrected visual acuity as assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) method from baseline to week 52|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||letters read correctly||Standard Deviation|Mean
2701560|NCT01233609|Secondary|Static Perimetry Volume--30 Degree Hill of Vision|Mean Change from baseline to week 52 for Static Perimetry Volume --30 Degree Hill of Vision. Full field static perimetry protocol was followed using the Octopus 900 (Haag-Streit) for a single session for each eye.|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||db-steridans|eyes|Standard Deviation|Mean
2701561|NCT01233609|Secondary|Static Perimetry by Treatment Arm--Full Field Hill of Vision|Mean change from baseline at week 52 for Full field Hill of Vision (Static perimetry)|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||db-steridians|eyes|Standard Deviation|Mean
2701562|NCT01233609|Secondary|Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter|Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the I4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||Visual field area (degrees squared)|eyes|Standard Deviation|Mean
2701563|NCT01233609|Primary|Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter|Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the III4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||Visual field area (degrees squared)|eyes|Standard Deviation|Mean
2701564|NCT01233284|Secondary|FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.|||Litres||Standard Error|Mean
2701565|NCT01233284|Secondary|FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-12, FEV1 AUC12-24 and FEV1 AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.|||Litres||Standard Error|Mean
2701566|NCT01233284|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for nighttime awakenings|||Night awakenings||Standard Error|Mean
2701567|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.|||Puffs||Standard Error|Mean
2701568|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.|||Puffs||Standard Error|Mean
2701569|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.|||Puffs||Standard Error|Mean
2701570|NCT01233284|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent . Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and 4 weeks|FAS reduced to patients with non-missing morning and evening PEF data.|||Percentage of the mean daily PEF||Standard Error|Mean
2701571|NCT01233284|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing evening PEF data.|||Litre/min||Standard Error|Mean
2701572|NCT01233284|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing morning PEF data.|||Litre/min||Standard Error|Mean
2701573|NCT01233284|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing PEF data.|||Litre/min||Standard Error|Mean
2701574|NCT01233284|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
2701575|NCT01233284|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Mean
2701576|NCT01233284|Secondary|FVC AUC0-3h Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
2701981|NCT01230021|Secondary|Percentage of Subjects With One or More Adverse Events (AEs) Recorded||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||percentage (%) of subjects|||Number
2701578|NCT01233284|Secondary|Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
2701579|NCT01233284|Secondary|FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Mean
2701580|NCT01233284|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Mean
2701581|NCT01233284|Primary|Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response|Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|Full analysis set (FAS) reduced to patients with non-missing FEV1 data. The FAS is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.|||Litre||Standard Error|Mean
2701582|NCT01233258|Other Pre-specified|Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of rFVIII (BAY81-8973)|3, 6, 9 and 12 months after baseline|Safety population|||Participants|||Number
2701583|NCT01233258|Other Pre-specified|Number of Bleeds During Treatment|The number of bleeds experienced by each participant|12 months|ITT|||Bleeds||Inter-Quartile Range|Median
2701584|NCT01233258|Secondary|Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)|The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT|||Percentage of bleeds||Full Range|Median
2701585|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/ADJ Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ|Up to 6 months (6 months on CS/ADJ potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.|||Bleeds per year per participant||Standard Deviation|Mean
2701586|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/EP Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP|Up to 6 months (6 months on CS/EP potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.|||Bleeds per year per participant||Standard Deviation|Mean
2701587|NCT01233258|Primary|Annualized Number of All Bleeds|The annualized number of bleeds experienced by participants|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT (Intent to Treat). Low and high dose prophylaxis arms and both potencies combined as planned for the statistical analysis to achieve intended sample size.|||Bleeds per year per participant||Standard Deviation|Mean
2701588|NCT01233232|Secondary|Maximum Reduction of Circulating Neutrophils in Blood, From Baseline|The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.|Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)||||10^9/L cells/L||Standard Deviation|Mean
2701589|NCT01233232|Secondary|Time to Maximum Plasma Concentration for AZD5069|Time (in relation to dosing) at which the maximum plasma concentration is observed.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing||||hours||Inter-Quartile Range|Median
2701590|NCT01233232|Secondary|Maximum Plasma Concentration for AZD5069|The maximum plasma concentration (Cmax) is the highest level of drug in plasma.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2701591|NCT01233232|Secondary|Area Under the Plasma Concentration Curve of AZD5069|The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2701592|NCT01233232|Secondary|Plasma Concentration of AZD5069 After 1 Hour of Dosing|At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.|End of Treatment (Day 28), 1 hour after dosing||||nmol/L||Standard Deviation|Mean
2701593|NCT01233232|Primary|Change From Baseline to End of Treatment for Total Protein (Urinalysis)|The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||g/L||Standard Deviation|Mean
2701594|NCT01233232|Primary|Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)|High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).|Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])||||Participants|||Number
2701595|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)|The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||L||Standard Deviation|Mean
2701596|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)|The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||L||Standard Deviation|Mean
2701597|NCT01233232|Primary|Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)|The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||beats/minute||Standard Deviation|Mean
2701598|NCT01233232|Primary|Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)|The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||mmHg||Standard Deviation|Mean
2701599|NCT01233232|Primary|Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)|The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||mmHg||Standard Deviation|Mean
2701600|NCT01233232|Primary|Change From Baseline to End of Treatment for Body Temperature|The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||degrees C||Standard Deviation|Mean
2701601|NCT01233232|Primary|Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)|The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||10^9/L cells/L||Standard Deviation|Mean
2701602|NCT01233232|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||Participants|||Number
2701603|NCT01233232|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Last Observation on Treatment (up to Day 28)||||Participants|||Number
2701604|NCT01233232|Primary|Patients Who Experienced at Least One Adverse Events(s)|Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|From start of treatment (Day 0) up to 28 days (End of Treatment)||||Participants|||Number
2701605|NCT01233076|Primary|Overall Vision Quality|Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
2701606|NCT01233050|Secondary|Length of Hospital Stay||within 35 days of randomization to treatment assignment||||days||Standard Deviation|Mean
2701607|NCT01233050|Secondary|Number and Percentage of Participants With Organ Space Infection||within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
2701608|NCT01233050|Secondary|Number and Percentage of Participants With Deep Wound Infection||within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
2701609|NCT01233050|Secondary|Bacterial Pathogens Present in Documented Surgical Site Infection||within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
2701610|NCT01233050|Secondary|Time to Develop Surgical Site Infection|average time from surgery to surgical site infection diagnosis|within 35 days of randomization to treatment assignment||||days||Standard Error|Mean
2701611|NCT01233050|Primary|The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.|The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.|within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
2701612|NCT01232946|Primary|Myocardial Fatty Acid Esterification Rate|PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir|3 months||||umol/g/min||Inter-Quartile Range|Median
2701613|NCT01232946|Primary|Myocardial Fatty Acid Oxidation Rate|PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir|3 months||||umol/g/min||Inter-Quartile Range|Median
2701614|NCT01232946|Primary|Myocardial Glucose Uptake|PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir|3 months||||umol/g/min||Inter-Quartile Range|Median
2701615|NCT01232920|Secondary|Number of Eyes With Resolution of Macular Edema||6 months||||Eyes|Participants||Number
2701616|NCT01232920|Secondary|Change in Best Spectacle-corrected Visual Acuity (BSCVA)|Change in best spectacle-corrected visual acuity (BSCVA) from baseline. Analysis on eye level|6 months||||LogMAR|Participants|Standard Deviation|Mean
2701617|NCT01232920|Secondary|Time to Control of Inflammation||6 months||||days||Inter-Quartile Range|Median
2701685|NCT01232504|Secondary|Graft Versus Host Disease (aGVHD) Related Mortality|Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
2701618|NCT01232920|Primary|Number of Participants Achieving Treatment Success|"TREATMENT SUCCESS is defined as controlled ocular inflammation in both eyes with less than or equal to 10 mg/day of prednisone and/or 2 topical steroid drops/day sustained for 2 visits separated by at least 28 days (control of inflammation and prednisone dose must be achieved by 5-month visit and sustained until 6-month visit).~Discontinuation of study medication at any time due to efficacy, tolerability, or safety may result in a declaration of TREATMENT FAILURE. Note that all patients will be classified as either a treatment success or failure."|6 months||||participants|||Number
2701619|NCT01232894|Primary|Change From Baseline on Clinical COPD Questionnaire (CCQ) Score|The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.|Baseline and 12 weeks|Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.|||units on a scale||Standard Deviation|Mean
2701620|NCT01232868|Secondary|Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures|The secondary outcomes will identify the number of participants with a positive B cell response to the flu shot particulary looking for antibody responses, presence of plasmablasts, antibody repertoire.|2 years||||participants|||Number
2701621|NCT01232868|Primary|Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures|The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.|Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)||||participants|||Number
2701622|NCT01232829|Secondary|Time to Disease Progression|Eighteen patients were evaluable for the time to disease progression endpoint.|From registration to documentation of disease progression, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the progression-free survival.|||months||95% Confidence Interval|Median
2701623|NCT01232829|Secondary|Survival|Survival was estimated using the Kaplan-Meier (1958) method.|From registration to death due to any cause, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the overall survival endpoint.|||months||95% Confidence Interval|Median
2701624|NCT01232829|Primary|Survival Rate|The primary endpoint of the study was 6-month survival. The proportion of successes was estimated by the number of successes divided by the total number of evaluable patients.|6 months|All patients meeting the eligibility criteria and who received treatment were considered evaluable for the primary endpoint. All patients treated per protocol (n=18) were evaluable for the 6-month survival endpoint.|||participants|||Number
2701625|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Change from PreScreening at End of Trial|Analyses only used matched cases and does not include participants with incomplete data.|||units on a scale||Standard Deviation|Mean
2701626|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|End of Trial|Per protocol|||units on a scale||Standard Deviation|Mean
2701627|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Pre Screening|Per protocol|||units on a scale||Standard Deviation|Mean
2701628|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Per protocol|||units on a scale||Standard Deviation|Mean
2701686|NCT01232504|Secondary|Relapse Related Mortality|Relapse related mortality after a median follow-up of 600 days.|3～1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
2702305|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Threshold|RA pacing threshold results were reported for implant|implant|56 CRT-D and 11 ICD patients had data available at implant|||volts (V)||Standard Deviation|Mean
2701629|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.|||units on a scale||Standard Deviation|Mean
2701630|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Per protocol|||units on a scale||Standard Deviation|Mean
2701631|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those dropped out from the study.|||units on a scale||Standard Deviation|Mean
2701632|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
2701633|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 1st Leg of Crossover|Per protocol|||units on a scale||Standard Deviation|Mean
2701634|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Change from Baseline at Follow Up (Baseline - Follow Up)|Subjects analyzed are those with complete data at all timepoints and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701635|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 1st Leg of Crossover (5 Days)|Per protocol|||units on a scale||Standard Deviation|Mean
2701636|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up in the crossover and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701687|NCT01232504|Secondary|IFD Related Mortality|IFD-related mortalities after a median follow-up of 600 days.|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants||95% Confidence Interval|Number
2701637|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).|||units on a scale||Standard Deviation|Mean
2701638|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at 2nd follow up in the crossover and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701639|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.|||units on a scale||Standard Deviation|Mean
2701640|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701641|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
2701642|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Change from Baseline at Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701643|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701644|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).|||units on a scale||Standard Deviation|Mean
2701645|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
2701759|NCT01231750|Primary|Symptom-limited Exercise Duration as an Indicator of Exercise Capacity|Subjects walked on the treadmill as long as they could tolerate, symptom-limited.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
2701646|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Change from Baseline at Follow Up (5 days)|Subjects analyzed are only those with complete data at baseline and 5 day follow up in the study.|||units on a scale||Standard Deviation|Mean
2701647|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
2701648|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
2701649|NCT01232738|Other Pre-specified|Change in ORAC Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Trolox equivalents||95% Confidence Interval|Mean
2701650|NCT01232738|Other Pre-specified|Change in ORAC Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||umol Trolox equivalents||95% Confidence Interval|Mean
2701651|NCT01232738|Other Pre-specified|Change in ORAC Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Trolox equivalents||95% Confidence Interval|Mean
2701652|NCT01232738|Other Pre-specified|Change in BCL2/BAX Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 10 subjects that completed the study were able to have this biomarker analyzed.|||Ratio||95% Confidence Interval|Mean
2701653|NCT01232738|Other Pre-specified|Change in Percent Annexin V Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Annexin V %||95% Confidence Interval|Mean
2701654|NCT01232738|Other Pre-specified|Change in Mitotracker Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Relative Fluorescent Intensity||95% Confidence Interval|Mean
2701655|NCT01232738|Other Pre-specified|Change in JC-1 Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 14 subjects that completed the study were able to have this biomarker analyzed.|||ratio||95% Confidence Interval|Mean
2701656|NCT01232738|Secondary|Difference in Time to Treatment Failure|This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more.|up to 12 months|Failure was defined as death, endotracheal intubation, tracheostomy-assisted ventilation, or use of noninvasive ventilation 23 hours/day for 14 days or more. It is defined in years.|||years||95% Confidence Interval|Median
2701657|NCT01232738|Primary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)|The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function)|up to 12 months|The placebo arm are from the randomized, controlled studies in ALS performed during 2004-2010, corrected for symptom duration.|||units on a scale||Standard Error|Mean
2701658|NCT01232569|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||g/L||Standard Deviation|Mean
2701659|NCT01232569|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2701660|NCT01232569|Secondary|Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2701661|NCT01232569|Secondary|Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients|||Number
2701662|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2701663|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2701664|NCT01232569|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2701675|NCT01232556|Primary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..|Up to 20 weeks after the first dose of study drug|Safety Population - included all participants who received at least 1 dose of test article (either inotuzumab ozogamicin administrated in combination with rituximab or investigator’s choice). This population only excluded participants who never received any test article.|||Percentage of Participants|||Number
2701665|NCT01232569|Secondary|Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2701666|NCT01232569|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2701667|NCT01232569|Secondary|Change From Baseline in the Patient's Pain Visual Analog Score|"Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented no pain and the extreme right end represented unbearable pain. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain."|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2701668|NCT01232569|Secondary|Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score|"Patients and physicians assessed the patient's disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented no disease activity (symptom-free and no arthritis symptoms) and the extreme right end represented maximum disease activity. Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity."|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2701669|NCT01232569|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||mm/hr||Standard Deviation|Mean
2701670|NCT01232569|Secondary|Change From Baseline in C-reactive Protein at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||mg/dL||Standard Deviation|Mean
2701671|NCT01232569|Secondary|Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24|Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Joint count||Standard Deviation|Mean
2701672|NCT01232569|Secondary|Time to Onset of ACR20, ACR50, and ACR70 Responses|Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Days||95% Confidence Interval|Median
2701673|NCT01232569|Secondary|Percentage of Patients With ACR50 and ACR70 Responses at Week 24|A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2701674|NCT01232569|Primary|Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2701676|NCT01232556|Secondary|Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire|FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.|Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported|ITT population|||Unit on a scale||95% Confidence Interval|Mean
2701677|NCT01232556|Secondary|Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire|EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.|Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported|ITT population|||Unit on a scale||95% Confidence Interval|Mean
2701678|NCT01232556|Secondary|Duration of Response|The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT population; only participants with a CR, unCR, PR, or unPR were included in the analysis|||Months||95% Confidence Interval|Median
2701679|NCT01232556|Secondary|Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL|"CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).~Partial Response (PR) requires the following:~≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.~No increase in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.~With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR).~The 95% CI was determined using the exact method based on binomial distribution."|Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
2701680|NCT01232556|Secondary|Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL|"CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).~Partial Response (PR) requires the following:~≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.~No increase in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.~With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution."|Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
2701681|NCT01232556|Secondary|Progression-Free Survival (PFS)|"PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.~PD requires the following:~Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT Population|||Months||95% Confidence Interval|Median
2701682|NCT01232556|Primary|Overall Survival|Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.|ITT Population.|||Months||95% Confidence Interval|Median
2701683|NCT01232504|Secondary|Infection Related Mortality|Infection related mortality after a median follow-up of 600 days.|3～1099 days)|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
2702306|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Threshold|RV pacing threshold results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit.|||volts (V)||Standard Deviation|Mean
2701688|NCT01232504|Primary|Incidences of Invasive Fungal Diseases (IFD)|The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation|100 day post transplant|The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients .|||percentage of partipants|||Number
2701689|NCT01232504|Secondary|Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)|Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).|100 days post transplant|The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients .|||percentage of partipants||95% Confidence Interval|Number
2701690|NCT01232504|Secondary|Transplant Related Mortality|Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).|100 days post transplant|The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients .|||percentage of participants||95% Confidence Interval|Number
2701691|NCT01232504|Secondary|Hematological Engraftment|The median time of neutrophil and platelet recovery .|100 days post transplant|The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients .|||days||Full Range|Median
2701692|NCT01232491|Secondary|Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.|||rate per year of patient exposure|||Number
2701693|NCT01232491|Secondary|Rate of All Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.|||rate per year of patient exposure|||Number
2701694|NCT01232491|Secondary|Rate of Treatment Emergent Adverse Events (TEAEs)|Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.|||rate per 100 years of patient exposure|||Number
2701695|NCT01232491|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
2701696|NCT01232491|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2701697|NCT01232491|Secondary|Change From Baseline in Body Mass Index (BMI)|Estimated mean change from baseline in BMI after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||kg/m^2||Standard Error|Least Squares Mean
2701698|NCT01232491|Primary|Change From Baseline in Body Weight|Estimated mean change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2701699|NCT01232465|Primary|Pregnancy|detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth|9 months||||participants|||Number
2701700|NCT01232452|Secondary|Immunogenicity of Cixutumumab||Preinfusion, Cycle1(C1): 1, 72, 168, 240, 336 hours(hrs); C2 and C3: 1, 168, 336 hrs; C4: 1, 24,72,120,168, 240, 336, 504 hrs, Postinfusion; 30 Day Follow Up|Zero participants were analyzed due to no immunogenicity analysis was done and the assay was never developed.||||||
2701701|NCT01232452|Secondary|Pharmacodynamics (PD) Markers: Free Insulin-like Growth Factor-I (IGF-I, Total IGF-I, and IGF Binding Proteins (IGFBP-3)|Blood samples for the determination of PD marker concentrations were collected at the specified time points for all participants. Analysis of the following markers include free IGF-I, total IGF-I, and IGFBP-3.|Preinfusion, Cycle 2, Cycle 4, Cycle 8, Postinfusion, 30-Day Follow-Up|Zero participants were analyzed for PD Biomarker IGF-I, total IGF-I, and IGFBP-3 due to blood samples were not collected in order to assess biomarker data.||||||
2701702|NCT01232452|Secondary|PK: Area Under the Concentration Time Curve During 1 Dosing Interval (i.e. 504 hr, AUC(0-tau) of Cixutumumab, Cycle 4 (i.e. Fourth Infusion)||Prior to Infusion (of Cycle 4), 1, 24, 72, 120, 168, 240, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)|Participants who were randomized to the cixutumumab arm and had evaluable PK data.|||(ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2701703|NCT01232452|Secondary|PK: Area Under the Concentration Time Curve (AUC[0-inf]) of Cixutumumab, Cycle 1 (i.e. First Infusion)||Prior to Infusion (of Cycle 1), 1, 72, 168, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 2)|Participants who were randomized to the cixutumumab arm and had evaluable PK data.|||microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2701704|NCT01232452|Secondary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Cixutumumab, Cycle 1 (First Infusion) and Cycle 4 (Fourth Infusion)||First Infusion: [Prior to Infusion (of Cycle1): 1, 72, 168, 336 hours(hrs) and 504 hrs (i.e. Prior to Infusion of Cycle 2)] and Fourth Infusion; [Prior to Infusion (of Cycle 4),1,24,72,120,168,240,336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)]|Participants who were randomized to the cixutumumab arm and had evaluable PK data.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2701705|NCT01232452|Secondary|Change in Tumor Size (CTS)|CTS was measured by percentage change of tumor size at the end of Cycle 2 comparing to baseline tumor size.|Change from baseline measurement to the end of Cycle 2, average of 42 days|All randomized participants.|||Percent Change||Standard Deviation|Mean
2701706|NCT01232452|Secondary|Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score|TTPS was defined as the time from the date of randomization until the date of worsening of symptoms as measured by Lung Cancer Symptom Scale (LCSS) score. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI) that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). For each participant, the maximum improvement over baseline score was calculated for each of the 9 LCSS items, ASBI and LCSS total score. Participants without event are censored at the date of the last LCSS assessment. TTPS was estimated using the Kaplan-Meier method.|Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months|All randomized participants. Participants censored in Cixutumumab arm = 38 and Pemetrexed + Cisplatin arm = 46.|||Months||95% Confidence Interval|Median
2701707|NCT01232452|Secondary|Time to Progressive Disease (TTPS)|TTPS was defined as the time from the date of randomization until the date of disease progression. Disease progression was assessed via RECIST version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing non-target lesions.TTPS was estimated using the Kaplan-Meier method.|Randomization Date to Disease Progression Up to 18.3 Months|All randomized participants. Participants censored in Cixutumumab arm = 39 and in the Pemetrexed + Cisplatin arm = 36.|||Months||95% Confidence Interval|Median
2701708|NCT01232452|Secondary|Duration of Response (DOR)|Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for PD is met, or death, is objectively documented. DOR was estimated using the Kaplan-Meier method. Disease progression was assessed via RECIST version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing non-target lesions|Time from Response to Disease Progression or Death from Any Cause Up to 20 Months|All randomized participants who had CR or PR. Participants censored in Cixutumumab arm = 10 and Pemetrexed + Cisplatin arm = 8.|||Months||95% Confidence Interval|Median
2701709|NCT01232452|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. OS was estimated using the Kaplan-Meier method.|Randomization Date to Death From Any Cause Up to 20 Months|All randomized participants. Participants censored cixutumumab arm = 47 and pemetrexed + cisplatin arm = 39.|||Months||95% Confidence Interval|Median
2701710|NCT01232452|Secondary|Percentage of Participants Achieving an Objective Response Rate (ORR)|The ORR is the percentage of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. ORR is confirmed best overall tumor response of CR and PR. CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.|Randomization to Disease Progression Up to 18.3 Months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2701711|NCT01232452|Primary|Progression-free Survival (PFS)|PFS was defined as the time from date of randomization until the date of disease progression, or death from any cause, whichever was first. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation for disease progression or death were censored at the date of last tumor assessment. The PFS was estimated following the Kaplan-Meier method.|Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months|All randomized participants. Participants censored in Cixutumumab arm = 20 and Pemetrexed + Cisplatin arm = 21.|||months||95% Confidence Interval|Median
2701712|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258|The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile|||(ng.h/mL)||Standard Deviation|Mean
2701713|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258|Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile|||hours||Full Range|Median
2701760|NCT01231646|Primary|Levels of Folate Receptor Autoantibodies|ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.|On the same day after informed consent was obtained||||ug/mL||Standard Deviation|Mean
2701714|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258|Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile|||(ng/mL)||Standard Deviation|Mean
2701715|NCT01232296|Secondary|Time to Definitive Deterioration in ECOG Performance Status (PS)|Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first|The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis|||Weeks||95% Confidence Interval|Median
2701716|NCT01232296|Secondary|Disease Control Rate (Tumor Assessment)|Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response [CR], partial response [PR] or stable disease [SD] according to RECIST 1.1.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.|||Participants|||Number
2701717|NCT01232296|Secondary|Time to Tumor Progression (Tumor Assessment)|Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.|||Weeks||95% Confidence Interval|Median
2701718|NCT01232296|Primary|Overall Survival - Overall Survival|The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.|||Weeks||95% Confidence Interval|Median
2701719|NCT01232283|Secondary|Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 260|The apremilast subjects as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||participants|||Number
2701720|NCT01232283|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260|The Apremilast-exposure Period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. Adverse events that started after 28 days of initiating placebo and before resuming apremilast treatment in the Randomized Treatment Withdrawal Phase (Weeks 32 to 52) were excluded in the Apremilast-exposure phase. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 260; The mean duration of exposure was 100.66 weeks.|Apremilast participants as treated, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||participants|||Number
2701761|NCT01231633|Secondary|Change in Central Mean Thickness Based on OCT|Change in Central Mean Thickness based on OCT from baseline to Month 6t|Baseline to 6 Months||||Microns on OCT||Full Range|Mean
2701721|NCT01232283|Secondary|Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 16|Safety population, included all participants who were randomized and received at least one dose of IP. Participants with a PASI ≥ 125% of Baseline score after last dose who did not have psoriasis rebound captured as a Treatment Emergent Adverse Event.|||participants|||Number
2701722|NCT01232283|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Baseline to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
2701723|NCT01232283|Secondary|Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment with loss of 50% PASI improvement (event), or the time between the re-randomization date and the date of the last PASI assessment in the randomized withdrawal phase prior to addition of topical/phototherapy or other effective psoriasis therapies, or resumption of apremilast 30 mg BID, or discontinuation, or Week 52 if no loss (censored), whichever was earlier|Weeks 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or Apremilast 30mg BID at Week 32.|||Weeks||95% Confidence Interval|Median
2701724|NCT01232283|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline|"PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome measure #1 for further description.~sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See Outcome Measure #2 for further description."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
2701725|NCT01232283|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|"The SF-36 was a 36-item general health instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).~Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
2701726|NCT01232283|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included|||units on a scale||Standard Error|Least Squares Mean
2701762|NCT01231633|Primary|The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm|Total Number of addiitonal Avastin injections during study- From baseline to Month 6|Baseline - Month 6||||Injections||Full Range|Mean
2701727|NCT01232283|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
2701728|NCT01232283|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||Percentage of Participants|||Number
2701729|NCT01232283|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|FAS consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||percent change||Standard Error|Least Squares Mean
2701730|NCT01232283|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area.~BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA - baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
2701731|NCT01232283|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator must have factored in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
2701732|NCT01232283|Primary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. .|||percentage of participants|||Number
2701763|NCT01231633|Primary|The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm|The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm|Baseline - Month 6||||Letters Gain/Loss||Full Range|Mean
2701733|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|9 months||||participants|||Number
2701734|NCT01232205|Secondary|Cell-free mRNA|Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))|40 weeks|||||||
2701735|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|40 weeks|||||||
2701736|NCT01232127|Secondary|Number of Participants With Abnormalities in Laboratory Test Results|PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN.|Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
2701737|NCT01232127|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities.|Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
2701738|NCT01232127|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2701739|NCT01232127|Primary|Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.|||Hours||Full Range|Median
2701740|NCT01232127|Primary|Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2701741|NCT01232127|Secondary|Number of Participants With Abnormalities in Vital Signs|Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.|Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
2701742|NCT01232127|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
2701743|NCT01231984|Secondary|Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia.~Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hyperglycemic events.|||Adverse Events|||Number
2701744|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)|"Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.~Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 12.7 primary analysis due to protocol deviations. The total population size evaluated for this analysis is therefore 113.|||HbA1c (%)||Standard Deviation|Mean
2701772|NCT01231620|Secondary|Number of Participants Who Were Permanently Discontinued From the Study Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.|Up to 42 days|Safety Population|||Participants|||Count of Participants
2701745|NCT01231984|Secondary|Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment.~Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously)."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hypoglycemic events.|||Adverse Events|||Number
2701746|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 12 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 12 mm study arm completed all main study visits. One of the subjects was excluded from all primary and secondary analyses due to protocol deviations.|||mm||Standard Error|Mean
2701747|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 8 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used in Period 1. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 8 mm study arm completed all main study visits. Two of the 115 subjects were excluded from all primary and secondary analyses due to protocol deviations. The total number of subjects analyzed for perceived pain for this study was therefore 113.|||mm||Standard Error|Mean
2701748|NCT01231984|Secondary|Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users|Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c.|Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.|Of the 226 subjects who were considered for the Primary analysis, 107 subjects had at least one dose of insulin that was at least 40 units. The glycemic control of this sub-group of subjects was analyzed as in the Primary Analysis.The same analysis was performed for the high insulin dose subjects, with the two longer PN study arms pooled together.|||HbA1C (%)||Standard Deviation|Mean
2701749|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)|"Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.~Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 8 primary analysis due to protocol deviations. The total population size evaluated for the primary objective (4 vs. 8) is therefore 113.|||HbA1c (%)||Standard Deviation|Mean
2701750|NCT01231841|Secondary|Reduction of VB Repertoire Associated With r-ATG/CsA Combination|"We will perform molecular analysis of the TCR repertoire to identify marker immunodominant clone specimens using VB typing."|Every 4 weeks|||||||
2701751|NCT01231841|Secondary|Comparison of the Level of IS as Assessed by Immuknow Assay in Responders and Non-responders||Every 2 weeks for 3 months beginning on day 1 of therapy and then monthly (for a total of 6 months)|||||||
2701752|NCT01231841|Primary|Patients Treated With Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) Achieving at Least a Partial Remission (PR) at 6 Months|Patients will be classified as responders if they have transfusion independence and meet two of the following three criteria: ANC greater than 500/mm3; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3. Transfusion independence is defined as no need for transfusions for one month prior to response assessment.|At 6 months||||participants|||Number
2701753|NCT01231750|Primary|Severity of Angina Was Measured.|Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.|Application was 45 minutes prior to exercise|||||||
2701754|NCT01231750|Primary|Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)|Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.|Phase 2 was not done.|||||||
2701755|NCT01231750|Primary|Maximal Estimated Workload (in METS)|Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
2701756|NCT01231750|Primary|Maximal ST Depression|Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
2701757|NCT01231750|Primary|Time-to-onset of Angina or Angina Equivalent Symptoms|Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
2701758|NCT01231750|Primary|Time-to-onset of 1mm ST Segment Depression|Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
2701764|NCT01231620|Secondary|Serum Concentration of IV Zanamivir|Pharmacokinetic samples were collected at four time points to characterize peak concentration (end of infusion; C[EOI]) after the first dose on Day 1 and on Day 4 to characterize the pre-dose concentration (C[0]), the peak concentration C(EOI), and the trough concentration at 11-12 hours post-dose (C[12]) of zanamavir. Data was summarized by Creatinine clearance (CL) Category. The dose on Day 1 is the initial dose (unadjusted) and the dose on Day 4 is the maintenance dose.|Day 1 and Day 4|Pharmacokinetic (PK) Population comprised of all participants who received IV zanamivir and underwent sparse PK sampling during the study from which one or more serum zanamivir concentrations was determined. This outcome was not analyzed for participants receiving oseltamivir 75 mg. Only the participants available at the time point were analyzed.|||microgram/Liter (mcg/L)||Standard Deviation|Mean
2701765|NCT01231620|Secondary|Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) and Day 4|On Baseline/Day 1, a 12-lead ECG was obtained within approximately 24 hours prior to dosing. The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. In the original protocol ECGs were also done on Day 4, however, amendment 2 removed this requirement and therefore not all participants had Day 4 ECGs.|Baseline (Day 1) and Day 4|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2701766|NCT01231620|Secondary|Median Quantity of Oxygen Delivery Measured at Baseline (Day 1) and During the Study|Oxygen delivery were assessed three times daily at Baseline (Day 1) and during the treatment period/hospitalization (ideally at least 6 hours apart) and once daily during inpatient/hospitalization and once at Post +5 days, +16 days, and +28 days clinic visits. The median quantity of oxygen delivery during the study was not summarized since the data was not collected in a way to accurately calculate values. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and during the study|This end point was not analyzed||||||
2701767|NCT01231620|Secondary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and up to 42 days|Safety Population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2701768|NCT01231620|Secondary|Number of Participants With the Indicated Treatment-emergent (TE) Grade (G) 3/4 Clinical Chemistry Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatine kinase, chloride, CO2/bicarbonate, creatinine, potassium, magnesium and sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and up to 42 days|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2701769|NCT01231620|Secondary|Number of Participants With the Indicated Hematology Values Shifts From Baseline (Day 1) and up to 42 Days|Blood samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), S/R Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and white blood cell (WBC) count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range for the indicated hematology parameters is summarized. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and up to 42 days|Safety Population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2701770|NCT01231620|Secondary|Number of Participants With the Indicated Chemistry Laboratory Values Shifts From Baseline (Day 1) and up to 42 Days|Samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), switch/rescue (S/R) Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino tranferase (AST), total bilirubin, calcium, creatine kinase, chloride, carbon dioxide content (CO2), creatinine, potassium, magnesium, sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range are summarized.|Baseline (Day 1) and up to 42 days|Safety Population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2701771|NCT01231620|Secondary|Number of Participants With Any Severe or Grade 3/4 Treatment-related AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assessed by the Investigator as related or not related to the study treatment.|Up to 42 days|Safety Population|||Participants|||Count of Participants
2701773|NCT01231620|Secondary|Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.|Up to 42 days|Safety Population|||Participants|||Count of Participants
2701774|NCT01231620|Secondary|Number of Participants With Any Severe or Grade 3/4 AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of AEs. Grade 3=severe; Grade 4=potentially life threatening.|Up to 42 days|Safety population|||Participants|||Count of Participants
2701775|NCT01231620|Secondary|Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. All AEs were assessed by the Investigator as related or not related to the study treatment.|Up to 42 days|The Safety Population comprised of all randomized participants who received at least one dose of investigational product and assessed according to their actual treatment received, regardless of the randomization assigned.|||Participants|||Count of Participants
2701776|NCT01231620|Secondary|Number of Participants With Resistance-associated Mutations Detected in the Neuraminidase (NA) and Hemagglutinin (HA) Gene of Influenza A and B Viruses in Nasopharyngeal Swabs and Endotracheal/BAL Samples|Nasopharyngeal swabs and endotracheal /BAL samples were collected for viral susceptibility analysis. Susceptibility analyses consisted of phenotyping and genotyping. Resistance mutations were detected by genotyping. Viral susceptibility to zanamivir and oral oseltamivir at Baseline and throughout treatment determined by NA and HA (gene of influenza A and B viruses) sequence analysis and NA enzyme inhibition. Number of participants with viral mutation events are summarized, this includes all resistance mutations (substitutions) i.e. those present at Baseline and those that emerged during treatment.|Baseline (Day 1) and up to 42 days|IPP Population|||Participants|||Count of Participants
2701777|NCT01231620|Secondary|Median Time to no Detectable Viral RNA and the Absence of Cultivable Virus in Any Obtained Sample (Upper and Lower Respiratory Samples)|Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples, where available) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment). Endotracheal aspirates were collected in participants who were intubated. If treatment was continued beyond Day 5, additional samples were taken on Treatment Day 6, Day 8, Day 10, and/or the day of the last dose of randomized treatment, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R treatment. If the participant was symptomatic and hospitalized, samples were taken on the Post-treatment+2, +5, +9, +16 assessment days, and at the Post-Treatment +28 Day. Assessment of samples was done by quantitative RT-PCR.|Baseline (Day 1) and up to 42 days|IPP Population. Only those participants available at the specified time points were analyzed. Data also presented for participants positive at Baseline.|||Days||Full Range|Median
2701778|NCT01231620|Secondary|Number of Participants With no Detectable Viral RNA and the Absence of Cultivable Virus in Lower Respiratory Samples (Bronchoalveolar Lavage Sample [BAL], Endotracheal Aspirate)|Lower respiratory samples included BAL and endotracheal aspirates. Endotracheal aspirates were requested in participants (par.) who were intubated. Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment [trt]). Endotracheal aspirates were collected in participants who were intubated. If trt was continued beyond Day 5, additional samples were taken on Trt Day 6, Day 8, Day 10, and/or the day of the last dose of randomized trt, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R trt. If the par. was symptomatic and hospitalized, samples were taken on the Post-Trt +2, +5, +9, +16 assessment days, and at the Post-Trt [PT]+28 Day assessment. Assessment of samples was done by quantitative RT-PCR and viral culture.|Baseline (Day 1) and up to 42 days|IPP Population. Data is presented for participants positive at Baseline. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2701779|NCT01231620|Secondary|Change From Baseline Viral Load (Influenza A or B) by qPCR From Nasopharyngeal Swabs Positive at Baseline|Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the post-treatment +2, +5, +9, +16 and +28 day assessment. Viral load as measured by PCR. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable|IPP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles)|||log10 vp/mL||Full Range|Median
2701986|NCT01230021|Secondary|Maximum Plasma Concentration (Cmax) for FXIII|Maximum plasma concentration of the drug reached.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||U/mL||Standard Deviation|Mean
2701780|NCT01231620|Secondary|Change From Baseline in Quantitative Virus Culture From Nasopharyngeal Swabs Positive at Baseline|Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day1, S/R Day3, S/R Day5, or S/R Day6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16 and +28Day assessment. Viral load was measured by Quantitative Virus Culture, log10 50% Tissue Culture Infectious Dose (TCID50)/milliliter (mL). Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus Baseline value .|Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable|IPP Population. Only those participants available at the specified time points were analyzed.|||log10 TCID50/mL||Full Range|Median
2701781|NCT01231620|Secondary|Median Time to Virologic Improvement|Virologic improvement is defined as a 2 log drop in viral load or sustained undetectable viral ribonucleic acid (RNA) (on two successive occasions) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples. Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Days 6, 8, 10 and on the last day of randomized treatment. For participants who utilized the Switch (S)/Rescue (R) option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Nasopharyngeal swabs were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16, and +28 day assessment.|Baseline (Day 1) and up to 42 days|IPP Population. Only those participants available at the specified time points were analyzed. Data presented is for participants positive at Baseline.|||Days||Full Range|Median
2701782|NCT01231620|Secondary|Median Time to the Absence of Fever and Improved Respiratory Status, Oxygen Saturation, Heart Rate, and Systolic Blood Pressure|The absence of fever is defined as a non-axillary temperature recording <=36.6 degrees Celsius axillary, <= 37.2 degrees Celsius oral or <= 37.7 degrees Celsius core. Respiratory Status (RS) response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), or the need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate =<24 breaths/minute (without supplemental oxygen). Oxygen saturation response criteria: >=95% (without supplemental oxygen). Heart rate response criteria: =<100 beats/minute. Systolic blood pressure response criteria: >=90 millimeters of mercury. Vital signs were assessed three times daily during the treatment period/hospitalization. Vital signs were assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit.|Baseline (Day 1) and up to 42 days|IPP Population|||Days||Full Range|Median
2701783|NCT01231620|Secondary|Median Time of Duration of Hospitalization and Intensive Care Unit (ICU) Stay|Hospital duration and ICU duration was assessed from the first day of dosing. Hospital duration was calculated as the discharge date minus the admission date + 1. Hospital duration while on study was the earlier of discharge, completion, or withdrawal minus the later of the admission date or the study start date + 1. ICU duration-Modified was calculated as the original ICU duration minus ICU days prior to Study Day 1.|Day 1 to the end of the study (assessed up to 42 days)|IPP population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2701784|NCT01231620|Secondary|Median Time of Duration of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation|Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitalization and once at each post-treatment clinic visit.|Baseline (Day 1) and up to 42 days|IPP Population. Only those participants available with the indicated ventilator support or oxygen supplementation were analyzed.|||Days||Full Range|Median
2701785|NCT01231620|Secondary|Number of Participants With the Indicated Ventilation Status: Modality of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation|"Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD), no supplemental oxygen (O2) or ventilation support, Respiratory support at any time (AT) on study and at Baseline (Day 1) are summarized. Data for the any time (AT) on study time point was reported."|Up to 42 days|IPP Population|||Participants|||Count of Participants
2701786|NCT01231620|Secondary|Number of Participants With Complications of Influenza and Associated Antibiotic Use|The number of participants with complications of influenza and associated antibiotic use were summarized|Up to 42 days|IPP Population|||Participants|||Count of Participants
2701787|NCT01231620|Secondary|Median Time of Duration of Clinical Symptoms of Influenza|Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient/hospitalization and once at each post-treatment assessment.|Up to 42 days|IPP Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2701788|NCT01231620|Secondary|Number of Participants With the Indicated Clinical Symptoms of Influenza|Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient hospitalization and once at each post-treatment assessment.|Up to 42 days|IPP Population|||Participants|||Count of Participants
2701789|NCT01231620|Secondary|Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale|Median time to return to pre-morbid level of activity was assessed once daily during treatment/hospitalization and once at each post-treatment assessment and was measured using the 3- point scale (bed rest, limited ambulation, or unrestricted).|Up to 42 days|IPP Population. Participants succeeded in pre-morbid functional status were analyzed.|||Days||Full Range|Median
2701987|NCT01230021|Secondary|Area Under the Concentration vs. Time Curve (AUC0-∞)|A measure of exposure.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||IU*h/mL||Standard Deviation|Mean
2701790|NCT01231620|Secondary|Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study|Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. The number of participants who returned to their pre-morbid functional status at the end of the study assessed per the Katz ADL score (bathing, dressing, toileting, transferring, continence and feeding activities) is summarized.|Up to 42 days|IPP Population|||Participants|||Count of Participants
2701791|NCT01231620|Secondary|Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score|Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. Median time to return to pre-morbid functional status was assessed via the Katz ADL score (bathing, dressing, toileting, transferring, continence, and feeding activities). For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent.|Up to 42 days|IPP population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2701792|NCT01231620|Secondary|Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score|The Katz ADL scores were collected for bathing, dressing, toileting, transferring, continence, and feeding activities and were assessed once daily during the treatment period/hospitalization and once at each post-treatment Clinic Visit. For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline is defined as the difference at each time point (Day 5/6, and Day 10/11, and last day S/R if treatment was extended beyond 5 days) and the end of the study (post-treatment [PT] +28 Days) compared to Baseline.|Baseline (Day 1) and up to 42 days|IPP population. Only those participants available at the specified time points were analyzed.|||Scores on the scale||Standard Deviation|Mean
2701793|NCT01231620|Secondary|Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit|The number of participants who died on or before Day 14, Day 28, and the End of Study Visit were summarized.|On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days)|IPP Population|||Participants|||Count of Participants
2701794|NCT01231620|Secondary|Percentage of Participants With Respiratory Improvement|Respiratory Status (RS) is a component of TTCR. Response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), a need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate of =<24 breaths/minute (without supplemental oxygen). Data are presented as the percentage of participants achieving respiratory improvement.|Up to 42 days|IPP Population|||Percentage of participants|||Number
2701795|NCT01231620|Primary|Time to Clinical Response (TTCR) in Participants With Confirmed Influenza|Clinical response is defined as the resolution of at least 4 of the 5 vital signs (temperature, oxygen saturation, respiratory status, heart rate, systolic blood pressure) within the respective resolution criteria, maintained for at least 24 hours, or hospital discharge, whichever occurred first. This analysis was performed for Influenza positive population, for those with symptom onset less than or equal to (<=) 4 days, and for those on mechanical (mech) ventilation or in intensive care unit (ICU). 99 days is censored time for the participants who did not achieve TTCR.|Up to 42 days|ITT-E population comprised of all randomized participants who received at least one dose of investigational product. The Influenza positive population (IPP) is comprised of all participants in the ITT-E population with proven influenza infection.|||Days||Full Range|Median
2701796|NCT01231607|Secondary|Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24|Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15).|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
2701797|NCT01231607|Secondary|Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24|"Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: Since the start of treatment, when I look at my thinning area, I can see..., Since the start of treatment, my hair now covers…, and Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is… -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9)."|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
2701798|NCT01231607|Secondary|Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2701799|NCT01231607|Secondary|Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2701800|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.|||participants|||Number
2701801|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.|||participants|||Number
2701802|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
2701803|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
2701804|NCT01231607|Secondary|Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
2701805|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
2701806|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
2701982|NCT01230021|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state (Vss) is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Steady state is achieved when all variables are constant in spite of ongoing processes.|At steady state|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||mL/kg||Standard Deviation|Mean
2701807|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||millimeters||Standard Error|Least Squares Mean
2701808|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||millimeters||Standard Error|Least Squares Mean
2701809|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.|||Hair count||Standard Error|Least Squares Mean
2701810|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.|||Hair count||Standard Error|Least Squares Mean
2701811|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
2701812|NCT01231607|Primary|Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
2701813|NCT01231581|Secondary|Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The CTCAE version 3.0 displays Grades 1 through 5, with unique clinical descriptions of the severity for each toxicity based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.|||participants|||Number
2702307|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Threshold|RV pacing threshold results were reported at pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge|||volts (V)||Standard Deviation|Mean
2701814|NCT01231581|Secondary|Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 displays Grades 1 through 5 based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.|||participants|||Number
2701815|NCT01231581|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Per protocol other events were considered SAEs like symptomatic left ventricular ejection fraction (LVEF) decreases or cases of central serous retinopathy (CSR) or retinal vein occlusion (RVO). AE and SAE data were collected from the start of the first dose of study treatment and continued until 28 days following discontinuation of the study treatment or death. Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.|||participants|||Number
2701816|NCT01231581|Secondary|Investigator-Assessed Duration of Response|Duration of response is defined, for the subset of participants with a CR or PR, as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).|From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months)|MD Population. Duration of response was assessed for only those participants with a CR or PR.|||Weeks||95% Confidence Interval|Median
2701817|NCT01231581|Secondary|Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)|CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). CR and PR were evaluated by the Investigator using standard criteria (RECIST version 1.1). Confirmation of response was not required.|From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|Measurable Disease (MD) Population: all randomized participants regardless of whether or not treatment was administered who had measurable disease at baseline|||participants|||Number
2701818|NCT01231581|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of radiological PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). PD was also based on unequivocal progression of existing non-target lesions. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, or did not have a documented date of progression or death, PFS was censored at the last adequate assessment.|From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|ITT Population|||weeks||95% Confidence Interval|Median
2701819|NCT01231581|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who were not dead at the time of analysis; such participants were considered censored.|From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered|||months||95% Confidence Interval|Median
2701820|NCT01231555|Secondary|Minimum and Maximum Plasma GSK2248761 Concentration at Week 2|"Maximum observed plasma concentration and minimum observed plasma concentration of GSK2248761 was recorded on Week 2. The PK parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Pro 4.1 or higher. Log transformed values have been presented.~All calculations of non-compartmental parameters were based on actual sampling times."|At Week 2|The PK Concentration Population included all participants who received GSK2248761, underwent intensive and/or limited PK sampling during the study, and provided evaluable GSK2248761 plasma concentration data. Only the participants available at the time of assessment were analyzed.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2702308|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Threshold|RV pacing threshold results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant.|||volts (V)||Standard Deviation|Mean
2701821|NCT01231555|Secondary|Number of Participants With Changes in Electrocardiogram (ECG) From Baseline (Day 1) Over 16 Weeks|The QTc interval was assessed by two methods Bazzette's method (QTc[b]) and Federica's method (QTc[f]). Baseline value was recorded at Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Change from Baseline values were categorized into <30 milliseconds (msec), >=30 but <60 msec, and >=60 msec. The data has been presented for QTcB and QTcF for participants prior to switching the therapy.|Baseline (Day 1) to 16 weeks|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination.|||Participants|||Count of Participants
2701822|NCT01231555|Secondary|Number of Participants Discontinuing the Study Drugs Due to AEs|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Number of participants quitting/ prematurely discontinuing the use of study drug(s) were recorded.|Up to 20 weeks|Safety population|||Participants|||Count of Participants
2701823|NCT01231555|Secondary|Number of Participants With HIV Disease Progression|Number of participants acquiring clinical disease progression or death during the treatment period were presented. Clinical disease progression was defined as the progression from Baseline (Day 1) HIV disease status in either of these categories; CDC Category A at baseline to CDC Category B event, CDC Category A at baseline to CDC Category C event, CDC Category B at baseline to CDC Category C event, CDC Category C at baseline to new CDC Category C event, CDC Category A, B or C at baseline to death. If no change occurs, it was termed as no disease progression.|Up to 20 Weeks|ITT-E population.|||Participants|||Count of Participants
2701824|NCT01231555|Secondary|Number of Participants With HIV Associated Conditions|HIV associated condition included recurrence of previous conditions. Centre for disease control (CDC) associated conditions and non-CDC associated conditions were planned to be monitored.|Up to 20 Weeks|ITT-E population.|||Participants|||Count of Participants
2701825|NCT01231555|Secondary|Change From Baseline (Day 1) in Plasma HIV-1 RNA Over Period|For summaries and analyses which use HIV-1 RNA level as a continuous measure, the logarithm to base 10 of the value was used. In cases where a sample was retested, the retest value was used. Baseline was defined as the value recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Data for participants prior to switch and after the switch has been presented.|Baseline (Day 1) up to Week 16|ITT-E population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination.|||log10 copies per milliliter||Standard Deviation|Mean
2701826|NCT01231555|Primary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 20 Weeks|Safety population included all randomized participants who were exposed to the study drug(s) with the exception of any participant with documented evidence of not having consumed any amount of the study drug.|||Participants|||Count of Participants
2701827|NCT01231555|Primary|Number of Participants With Plasma HIV-1 RNA Below 50 Copies/mL as a Function of Viral Load|"This analysis was based on the Missing, Switch or Discontinuation equals Failure (MSDF) algorithm (as codified by the FDA's snapshot algorithm) and was adjusted for stratification factors and stage of recruitment. Dose selection was based primarily on antiviral activity and tolerability in conjunction with immunologic, safety, virologic resistance and pharmacokinetic (PK) measures. The efficacy decision criteria was based on an observed difference of >=8% between the two GSK2248761 dosage arms."|Up to Week 16|Intent to treat exposed (ITT-E) population included all randomized participants who received at least one dose of study drug. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination. Only those participants available at indicated timepoints were analyzed.|||Participants|||Count of Participants
2701828|NCT01231516|Secondary|DTG PK Parameters Including AUC(0-tau)|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.|Week 4, Week 24, and Week 48|PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed.|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2701829|NCT01231516|Secondary|DTG PK Parameters Including Cmax, Cmin, C0, and C0_avg|The maximal concentration (Cmax), and the minimal concentration (Cmin) were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 as well as the average C0 (C0_avg) , Cmax and Cmin were estimated and reported here.|Week 4, Week 24, and Week 48|"PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X."|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2701830|NCT01231516|Secondary|Number of Participants With the Indicated Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. .|From Baseline until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study|Safety Population: all participants who received at least one dose of IP (i.e., DTG or RAL)|||Participants|||Number
2701831|NCT01231516|Secondary|Number of Participants With Indicated Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline (Day 1) until Week 48|mITT-E Population|||Participants|||Number
2701832|NCT01231516|Other Pre-specified|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value data for CD8+ cell count (cells per millimeters cubed [mm^3]) were only reported on a per-participant basis and were not summarized.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|mITT-E Population||||||
2701833|NCT01231516|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|"mITT-E Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each visit is indicated by n=X, X."|||cells/mm^3||Inter-Quartile Range|Median
2701834|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment."|Week 24, Week 48|mITT-E Population|||Participants|||Number
2701835|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis."|Week 24|mITT-E Population|||Participants|||Number
2701836|NCT01231516|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent INI Resistance at Time of Protocol Defined Virology Failure (PDVF)|For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|Baseline until PDVF up to Week 48|mITT-E Population|||Participants|||Number
2701846|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity."|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701837|NCT01231516|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study."|Week 48|Modified Intent-To-Treat Exposed (mITT-E) Population: all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.|||Percentage of participants|||Number
2701838|NCT01231503|Other Pre-specified|Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations|Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.|At Month 18 post vaccination|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||mIU/mL||95% Confidence Interval|Geometric Mean
2701839|NCT01231503|Other Pre-specified|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.|At Month 18 post vaccination|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701840|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|"Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination."|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701841|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|"Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive any vaccination at this time point"|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701842|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|"Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination."|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701843|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|"Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination."|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701844|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|"Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination."|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701845|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|"Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination."|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2702309|NCT01227785|Primary|Clinical Performance at1-month for LV Pacing Threshold|LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.|1-month|73 CRT-D patients had data available at 1-month visit.|||volts (V)||Standard Deviation|Mean
2701847|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive vaccination at this time point."|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701848|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity."|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701849|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity."|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701850|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity."|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701851|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity."|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701852|NCT01231503|Secondary|Concentrations of Antibodies Against Measles Antigens|"Concentrations of anti measles antibodies were determined by ELISA and expressed as GMCs in milli-international units per millilitre (mIU/mL).~The seropositivity cut-off value for the assay was ≥ 150 mIU/mL. Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups."|At Month 10|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||mIU/mL||95% Confidence Interval|Geometric Mean
2701853|NCT01231503|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was ≥ 15 EL.U/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701854|NCT01231503|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations|Anti-Polio 1, 2 and 3 antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in international units per mililiter (IU/mL) and tabulated. The seroprotection cut-off value for the assay was ≥ 8 IU/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals and did not take any immune modifying medication or had blood transfusions.|||IU/mL||95% Confidence Interval|Geometric Mean
2701855|NCT01231503|Secondary|Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off value for the assay was ≥ 0.15 µg/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||µg/mL||95% Confidence Interval|Geometric Mean
2701856|NCT01231503|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off value for the assay was ≥ 0.1 IU/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||IU/mL||95% Confidence Interval|Geometric Mean
2701864|NCT01231503|Secondary|Number of Subjects Reported With Serious Adverse Events (SAEs)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity."|From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.|||Participants|||Count of Participants
2701857|NCT01231503|Secondary|Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-off values for the assay were greater than or equal to (≥) 6.2 and 10 mIU/mL, respectively.|At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||mIU/mL||95% Confidence Interval|Geometric Mean
2701858|NCT01231503|Secondary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was greater than or equal to (≥) 0.5 EL.U/mL.|At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701859|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter|This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal WBC level was defined as > 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as < 1.0 Billions WBC/L.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701860|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter|This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G2, G3, G4 or Missing. Normal PLA level was defined as > 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as < 25 Billions PLA/L.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701861|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter|This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G 2, G 3, G 4 or Missing. Normal HAE level was defined as HAE > 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE < 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE < 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE < 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE < 7.0 g/dL.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701862|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter|This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701863|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter|This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal ALT level was defined as ALT< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as > 10.0 times the ULN.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2702310|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Threshold|LV pacing threshold results were reported at pre-discharge for CRT-D patients.|pre-discharge|75 patients had data available at pre-discharge|||volts (V)||Standard Deviation|Mean
2701865|NCT01231503|Secondary|Number of Subjects Reported With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group."|During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
2701866|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M10 for RTS,S 14-26-9M Group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701867|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701868|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2701869|NCT01231503|Primary|Number of Subjects Reported With Serious Adverse Events (SAEs)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity."|From study start at Month 0 up to Month 10.|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.|||Participants|||Count of Participants
2701870|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living|The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.|||Points on a scale||Standard Error|Least Squares Mean
2701871|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy|The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.|||Points on a scale||Standard Error|Least Squares Mean
2701872|NCT01231464|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)|The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.|Baseline through entire treatment period (Day 1 through Day 14)|Full Analysis Set (FAS): all participants who were randomized and received at least one dose of study medication. Only participants for whom both baseline and post-baseline data were available were included in this analysis.|||Points on a scale||Standard Error|Least Squares Mean
2702311|NCT01227785|Primary|Clinical Performance at Implant for LV Pacing Threshold|LV pacing threshold results were reported for CRT-D patients at implant.|implant|78 CRT-D patients had data available at implant.|||volts (V)||Standard Deviation|Mean
2701873|NCT01231412|Secondary|Number of Participants With Relapse/Progression|"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL, MDS >5% blasts by morphologic or flow cytometric evaluation of the BMA or appearance of extramedullary disease CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or numb"|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2701874|NCT01231412|Secondary|Number of of Participants Surviving Overall|Number of subjects surviving overall post-transplant.|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2701875|NCT01231412|Secondary|Number of Non-Relapse Mortalities|Number of subjects expired without disease progression/relapse.|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2701876|NCT01231412|Secondary|Number of Patients With Grades III-IV Acute GVHD|"Number of patients with grades III-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|Up to 100 days|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2701877|NCT01231412|Secondary|Number of Patients With Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2701878|NCT01231412|Primary|Number of Patients With Grades II-IV Acute GVHD|"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|At day 100 post-transplant|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2701879|NCT01231399|Primary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of death from any cause.|Up to 5 years.||||Months||95% Confidence Interval|Median
2701880|NCT01231399|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 5 years||||Months||95% Confidence Interval|Median
2701881|NCT01231399|Primary|Number of Subject With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years||||participants|||Number
2701882|NCT01231399|Primary|Maximum Tolerated Dose (MTD) of Everolimus|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Course 1 (first 28 days)|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg|||Number
2701908|NCT01230892|Primary|Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS|Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)|1 year|4 subjects either withdrew or were lost to follow-up and not included in analysis population. Additionally, one subject in the Atenolol arm was removed from analysis population due to IVUS occurring in the incorrect artery and one subject in the Nebivolol arm was removed due to the IVUS catheter malfunctioning.|||participants|||Number
2701883|NCT01231373|Secondary|Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance|The Independent Photography Review--Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians, evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (0-4, where 0=none and 4=very severe visible varicose veins).|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2701884|NCT01231373|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|"The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram fo the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4)."|8 weeks|patients with a baseline and week 8 visit.|||units on a scale||Standard Error|Mean
2701885|NCT01231373|Primary|Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)|The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.|8 weeks|Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit.|||units on a scale||Standard Error|Least Squares Mean
2701886|NCT01231334|Primary|Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percentage of participants|||Number
2701887|NCT01231334|Secondary|Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12|The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percentage of participants|||Number
2701888|NCT01231334|Secondary|Percent Change From Baseline in Total Lesion Count at Week 12|Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percent change||Full Range|Median
2701889|NCT01231334|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12|"Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percent change||Full Range|Median
2701890|NCT01231334|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12|Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percent change||Full Range|Median
2701891|NCT01231334|Secondary|Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity|The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percentage of participants|||Number
2726847|NCT01044745|Secondary|Event-free Survival|Estimated using Kaplan-Meier estimator.|From the date of transplant with relapse/progression or death as censored events, up to 2 years||||months||Full Range|Median
2701892|NCT01231334|Secondary|Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Score on a scale||Standard Deviation|Mean
2701893|NCT01231321|Secondary|Change in Disease Activity Score (DAS28) Compared With Baseline|The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).|Baseline and 24 weeks|All subjects with data available from both Baseline and Week 24 were included in this intent-to-treat (ITT) analysis.|||units on a scale||Standard Deviation|Mean
2701894|NCT01231321|Primary|Vital Sign Values|"Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory.~Note, in table, BP = blood pressure."|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis.|||participants|||Number
2701895|NCT01231321|Primary|Deviation From Normal Laboratory Ranges|"Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory.~Note abbreviations used in table:~Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate"|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.|||participants|||Number
2701896|NCT01231321|Primary|Changes of Physical Examination|Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.|Baseline and 24 weeks|All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.|||participants|||Number
2701897|NCT01231321|Primary|Frequency of Adverse Events|"Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported.~Note:~Severe events considerably interfered in patients' usual activities and may have been life-threatening.~Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness."|Up to 34 weeks (24 week study treatment plus 70-day follow-up period)|All enrolled subjects were included in this intent-to-treat (ITT) analysis.|||participants|||Number
2701898|NCT01231230|Primary|Maximum Change From Baseline in Airway Blood Flow (Qaw)||maximum change in Qaw within 240 minutes post drug inhalation||||change from baseline ( µl/min/ml)||Standard Error|Mean
2701899|NCT01230931|Secondary|Number of Participants With a Wound Complication|The number of wound complications (dehiscence, infection) or the need to return to the operating to address a wound complication will be recorded. Wound complications will be recorded from the day of surgery until an average of two weeks post-operatively (this study is an acute care study, so no data will be collected after the initial hospital stay).|at the time of discharge (about 2 weeks after surgery)||||Participants|||Count of Participants
2701900|NCT01230931|Secondary|Volume of Intra-operative Salvaged Blood Transfused|The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.|baseline through post-operative day 3||||milliliters||Standard Deviation|Mean
2701901|NCT01230931|Secondary|Units of Fresh Frozen Plasma (FFP) Transfused|The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.|baseline through post-operative day 3||||units||Standard Deviation|Mean
2701902|NCT01230931|Secondary|Units of Packed Red Blood Cells (pRBCs) Transfused|The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.|baseline through post-operative day 3||||units||Standard Deviation|Mean
2701903|NCT01230931|Secondary|Volume of Blood Products Transfused|The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.|baseline through post-operative day 3||||milliliters||Standard Deviation|Mean
2701904|NCT01230931|Secondary|Change in Hemoglobin Level|The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.|baseline, post-operative day 3||||grams per deciliter (g/dL)||Standard Deviation|Mean
2701905|NCT01230931|Secondary|Change in Hemoglobin Level|The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.|baseline, post-operative day 2||||grams per deciliter (g/dL)||Standard Deviation|Mean
2701906|NCT01230931|Secondary|Change in Hemoglobin Level|The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.|baseline, post-operative day 1||||grams per deciliter (g/dL)||Standard Deviation|Mean
2701907|NCT01230931|Primary|Intra-operative Rate of Blood Volume Loss|The amount of blood loss during the surgery as measured by cell saver and lap counts. The cell saver and lap count totals will be summed.|at the time of surgery||||milliliters per minute (mL/min)||Standard Deviation|Mean
2701909|NCT01230827|Secondary|Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48|Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
2701910|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48|Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
2701911|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48|Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
2701912|NCT01230827|Primary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48|Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
2701913|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel's Criteria).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
2701914|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
2701915|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent's criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
2701916|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud's agar.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
2701983|NCT01230021|Secondary|Total Plasma Clearance (CL)|The total plasma clearance is a measure of the elimination of a drug from the body. Drugs are excreted primarily by the kidneys into the urine. Clearance is calculated as 'CL=Dose / AUC0-30 days').|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||mL/h/kg||Standard Deviation|Mean
2701917|NCT01230801|Other Pre-specified|Change From Baseline in Upright Maximum Ventilatory Volume|Change from Baseline in Upright Maximum Ventilatory Volume. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point. No patient had baseline assessment in group of BMN 701 5 mg/kg.|||L/min||Standard Deviation|Mean
2701918|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Upright Maximum Inspiratory Pressure|Change from Baseline in Percent Predicted Upright Maximum Inspiratory Pressure. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point. No patient had baseline assessment in group of BMN 701 5 mg/kg.|||percentage of Predicted MIP||Standard Deviation|Mean
2701919|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Upright Maximum Expiratory Pressure|Change from Baseline in Percent Predicted Upright Maximum Expiratory Pressure. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point. No patient had baseline assessment in group of BMN 701 5 mg/kg.|||percentage of Predicted MEP||Standard Deviation|Mean
2701920|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Supine Forced Vital Capacity|Change from Baseline in Percent Predicted Supine Forced Vital Capacity. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point.|||percentage of Predicted Supine FVC||Standard Deviation|Mean
2701921|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Upright Forced Vital Capacity|Change from Baseline in Percent Predicted Upright Forced Vital Capacity. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 week|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point.|||percentage of Predicted Upright FVC||Standard Deviation|Mean
2701922|NCT01230801|Secondary|Change From Baseline in Six Minutes Walk Test|Change from Baseline in Six Minutes Walk Test. The 6MWT measured the maximum distance the subject could walk on a flat, hard surface in a period of 6 minutes|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point.|||meter||Standard Deviation|Mean
2701923|NCT01230801|Primary|Number of Participants With Adverse Events|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|24 weeks|Safety Population|||Participants|||Count of Participants
2701924|NCT01230788|Secondary|Prednisone Effect|To correlate the effect of prednisone on CD20 expression using serial measurements of CD20 expression in leukemic blasts.|one month after treatment|||||||
2701925|NCT01230788|Secondary|Minimal Residual Disease|To perform serial minimal residual disease (MRD) measurements to provide an objective determination of the effectiveness of this therapy.|one month after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
2701926|NCT01230788|Primary|Remission Induction Rate|To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one month|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
2701927|NCT01230788|Primary|Toxicities of Rituximab|To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.|two months after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
2701928|NCT01230788|Primary|4 Month Event Free Survival (EFS)|To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one year after enrollment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
2701929|NCT01230749|Secondary|Change From Baseline to Day 29 in Body Weight|Difference is calculated as the change in body weight in Least Square Mean (LSM) from baseline to Day 29 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 29|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||Kilograms||Standard Error|Least Squares Mean
2701930|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)|Difference is calculated as the geometric mean change in CRP from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. CRP was not measured for pioglitazone group.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||mg/dL||Standard Deviation|Geometric Mean
2702312|NCT01227785|Primary|Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1month|68 CRT-D and 43 ICD patients had data available at 1month visit.|||milli volt (mV)||Standard Deviation|Mean
2701931|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)|Difference is calculated as the geometric mean change in IL-18 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-18 was not measured for pioglitazone group. The unit of IL-18 is picograms per milliliter (pg/mL)|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||pg/mL||Standard Deviation|Geometric Mean
2701932|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)|Difference is calculated as the geometric mean change in IL-6 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-6 is a systemic inflammatory markers and is an independent predictors of insulin resistance and progression to type 2 diabetes mellitus. IL-6 was not measured for pioglitazone guoup. The unit of IL-6 is picograms per milliliter (pg/mL).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||pg/mL||Standard Deviation|Geometric Mean
2701933|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Resistance|Difference is calculated as the change in insulin resistance in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insuline sensitivity is measured by absolute change in Homeostasis Model Assessment of insulin resistance (HOMA-IR). Insulin sensitivity is HOMA-%S and HOMA-IR is the reciprocal of HOMA-%S. HOMA-IR calculated as: (Glucose [mg/dL]) multiplied by Insulin [pmol/L]) divided by (405 multiplied by 6.945). Lower value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-IR was not collected on Day 28.|||HOMA-IR score||Standard Error|Least Squares Mean
2701934|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Secretion|Difference is calculated as the change in insulin secretion in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insulin secretion is measured by the absolute change in Homeostasis Model Assessment of steady state islet beta cell (HOMA-%B). HOMA-%B calculated as: (360 multiplied by Insulin [pmol/L]) divided by ([Glucose {mg/dL} minus 63] multiplied by 6.945). Higher value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-%B was not collected on Day 28.|||HOMA-B score||Standard Error|Least Squares Mean
2701935|NCT01230749|Secondary|Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)|Difference is calculated as the change in FPG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for FPG was not collected on Day 28.|||mg/dL||Standard Error|Least Squares Mean
2701936|NCT01230749|Primary|Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)|Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.|From baseline (Day -1) to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||mg/dL||Standard Error|Least Squares Mean
2701937|NCT01230710|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.|||Percentage of participants|||Number
2701949|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.~Reference intervals include:~Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|6 months post enrollment/randomization||||mL/min/1.73 sqm||Standard Deviation|Mean
2726980|NCT01043094|Primary|Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))|Area under the curve from start to elimination for Pitavastatin.|48 hours||||nanogram hour per milliliter (ng•h/mL)||Standard Deviation|Mean
2701938|NCT01230710|Secondary|Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)|A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.|||Percentage of participants|||Number
2701939|NCT01230710|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrolment to the date of death from any cause.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.|||Days||Inter-Quartile Range|Median
2701940|NCT01230710|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.|||Days||95% Confidence Interval|Median
2701941|NCT01230710|Primary|Percentage of Participants With Progression-free Survival at Week 52|A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).|Full analysis set: All enrolled participants.|||Percentage of participants|||Number
2701942|NCT01230593|Secondary|Chalazion Size Difference Post-Treatment|Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment|baseline and 4-6 weeks|Intention to treat population|||millimeters||Standard Deviation|Mean
2701943|NCT01230593|Primary|Number of Participants With Complete Resolution|Defined as number of patients with chalazion size regression of 100%|4-6 weeks|Intention to treat population|||participants|||Number
2701944|NCT01230554|Secondary|Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).|For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters).|Over all study visits for 1 week|Eyes with VA results|||logMAR|eyes|Standard Error|Mean
2701945|NCT01230554|Secondary|Lens Evaluation - Movement|"To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with:~Primary gaze blink~Upgaze blink~Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence."|Over all study visits through 1 week|Eligible, dispense eyes with non-missing scores.|||eyes|eyes||Count of Units
2701946|NCT01230554|Secondary|Lens Evaluation - Centration|To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor.|Over all study visits through 1 week|Eligible, dispense eyes with non-missing scores.|||eyes|eyes||Count of Units
2701947|NCT01230554|Primary|Market Research Survey|Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.|1 week|Subjects who completed the survey.|||Participants|||Count of Participants
2701948|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.~Reference intervals include:~Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|12 months post enrollment/randomization||||mL/min/1.73 sqm||Standard Deviation|Mean
2701950|NCT01230489|Primary|Time From Catheter Implantation to First Exit Site Infection.|The outcome measure is the length of time from implantation until the patient has first exit site infection or two years which ever is shortest.|Two years|Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.||||||
2701953|NCT01230424|Secondary|Change in Patient's Global Assessment (Visual Analogue Scale).|"The response to the question, Considering all the ways your knee affects you, how much pain are you having today?, was measured and the change in the scoring was evaluated. The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters. Higher scores represent a higher level of disease activity or a worse global health. Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm||95% Confidence Interval|Mean
2701954|NCT01230424|Secondary|Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.|"Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness.~Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||units on a scale||95% Confidence Interval|Mean
2701955|NCT01230424|Secondary|Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.|"Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities.~Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||units on a scale||95% Confidence Interval|Mean
2701956|NCT01230424|Secondary|Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).|Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm^3||95% Confidence Interval|Mean
2701957|NCT01230424|Secondary|Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).|Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm^2||95% Confidence Interval|Mean
2701958|NCT01230424|Secondary|Change in Effusion Volume Measured on Knee MRI.|Change in effusion volume measured on knee MRI on the log scale. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||log mm^3||95% Confidence Interval|Mean
2701959|NCT01230424|Secondary|Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.|Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale. Missing data were imputed.|Baseline to 2 years.|All individuals were included in analysis, which was performed on multiply imputed data.|||log mm^3||95% Confidence Interval|Mean
2701960|NCT01230424|Primary|Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.|"Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain.~Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||units on a scale||95% Confidence Interval|Mean
2701961|NCT01230424|Primary|Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)|Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm||95% Confidence Interval|Mean
2701962|NCT01230307|Secondary|Vitamin D Genomics|Genotyped for the restricted fragment length polymorphism at the BsmI site. In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.|Baseline|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity, in addition there is significant time and costs associated with this measurement which would result in data that would lead to no conclusions, this outcome was not analyzed.||||||
2701963|NCT01230307|Secondary|Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire|Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.|6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.||||||
2701964|NCT01230307|Secondary|Exercise Capacity Measured by 6 Minute Walk Test||6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.||||||
2701965|NCT01230307|Primary|Biomarkers|Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).|6 months|Because enrollment was less than 30% of original goal (6 vs 4 subjects) and therefore would not have scientific validity and would be a waste of financial resources, this outcome was not analyzed.||||||
2701984|NCT01230021|Secondary|Mean Residence Time (MRT)|The mean residence time (MRT) of a drug in the body and related functions are derived for drugs which are intravenously administered.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||hours||Standard Deviation|Mean
2701966|NCT01230177|Primary|Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])|"DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.~DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission."|12 weeks||||percent change||Standard Deviation|Mean
2701967|NCT01230177|Secondary|Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values|"On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation."|12 weeks|The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).|||participants|||Number
2701968|NCT01230177|Secondary|Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values|"On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation."|12 weeks|The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).|||participants|||Number
2701969|NCT01230177|Primary|Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])|"DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.~DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission."|12 weeks||||Score||Standard Deviation|Mean
2701970|NCT01230177|Primary|Number of Participants With Treatment Related Adverse Events|Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.|12 weeks|The safety analysis population consisted of the participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.|||participants|||Number
2701971|NCT01230060|Primary|Visual Acuity|Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.|120-180 days (visit 4)|All non missing implanted eyes, consistent set|||Participants|||Number
2701972|NCT01230021|Secondary|Physical Examination (Evaluated as Normal/Abnormal)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||participants|||Number
2701973|NCT01230021|Secondary|Vital Signs - Blood Pressure (Systolic and Diastolic)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||mmHg||Standard Deviation|Mean
2701974|NCT01230021|Secondary|Vital Signs - Pulse||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||beats/minute||Standard Deviation|Mean
2701975|NCT01230021|Secondary|Clot Solubility Test (Evaluated as Normal/Abnormal)|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||participants|||Number
2701976|NCT01230021|Secondary|Coagulation Related Parameters - Prothrombin Time (PT) (Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||Sec||Standard Deviation|Mean
2701977|NCT01230021|Secondary|Coagulation Related Parameters - Activated Partial Thromboplastin Time (aPTT, Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||Sec||Standard Deviation|Mean
2701978|NCT01230021|Secondary|Coagulation Related Parameters - Fibrinogen||Day 0 and at day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||g/L||Standard Deviation|Mean
2701979|NCT01230021|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors (Neutralising Antibodies Against Factor XIII)||At screening and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||percentage of subjects|||Number
2701980|NCT01230021|Secondary|Percentage of Subjects With One or More Serious Adverse Events (SAEs)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||percentage of subjects|||Number
2701988|NCT01230021|Primary|Area Under the Concentration vs. Time Curve (AUC)|A measure of the exposure. Blood samples for the PK assessment were drawn pre-dose and up to 30 days after dosing. The PK of FXIII in children was assessed after a single i.v. dose of rFXIII 35 IU/kg.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||IU*h/mL||Standard Deviation|Mean
2701989|NCT01229943|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|From registration to time of death, assessed up to 3 years||||months||95% Confidence Interval|Median
2701990|NCT01229943|Secondary|Overall Response Rate|The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Up to 3 years||||percentage of participants|||Number
2701991|NCT01229943|Primary|Progression Free Survival|Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.|From study entry to the date of documented progression or death from any cause, up to 3 years||||months||95% Confidence Interval|Median
2701992|NCT01229891|Secondary|Serum High Density Lipoprotein (HDL)||12-week||||mg/dL||Standard Deviation|Mean
2701993|NCT01229891|Secondary|Serum Low Density Lipoprotein (LDL)||12-week||||mg/dL||Standard Deviation|Mean
2701994|NCT01229891|Secondary|Serum Total Cholesterol (Tchol)||12-week||||mg/dL||Standard Deviation|Mean
2701995|NCT01229891|Secondary|Serum Triglyceride (TG)||12-week||||mg/dL||Standard Deviation|Mean
2701996|NCT01229891|Secondary|Hemoglobin A1c (HbA1c)||12-week||||percent||Standard Deviation|Mean
2701997|NCT01229891|Secondary|Insulin|fasting serum insulin concentration|12-week||||mU/L||Standard Deviation|Mean
2701998|NCT01229891|Secondary|Fasting Serum Glucose (FSG)||12-week||||mg/dL||Standard Deviation|Mean
2701999|NCT01229891|Primary|Serum 25-hydroxyvitamin D||12-week||||nmol/L||Standard Deviation|Mean
2702000|NCT01229735|Secondary|Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52||From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.|||responders|||Number
2702001|NCT01229735|Secondary|Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52|Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.|From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.|||percent reduction||Inter-Quartile Range|Median
2702002|NCT01229735|Secondary|Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.|||month||Inter-Quartile Range|Median
2702003|NCT01229735|Secondary|Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.|||Participants|||Number
2702004|NCT01229735|Primary|Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate||From Baseline to Week 52|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.|||percentage of subjects|||Number
2702005|NCT01229722|Primary|Pill Count|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.|Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.|A total of 66 Boston Medical Center HIV-positive patients participated in this study. All patients in the study had stable ART prior to enrollment.|||proportion of pills taken as scheduled||Standard Deviation|Mean
2702006|NCT01229722|Primary|Self-Report|Participants were asked to recall what pills they took and what they missed. Adherence was measured by self report as well as Wise Pill and pill count.|Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.|A total of 66 Boston Medical Center HIV-positive patients participated in this study. All patients in the study had stable ART prior to enrollment.|||proportion of 7-day adherence||Standard Deviation|Mean
2702007|NCT01229722|Primary|Adherence to Anti-retroviral Therapy|MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.|Assessed at Baseline and 8 timepoints (every 3 weeks) over 24 weeks. T1 (Baseline), T2 (12 weeks), and T3 (24 weeks) reported here.|A total of 66 Boston Medical Center HIV-positive patients participated in this study. All patients in the study had stable ART prior to enrollment.|||proportion adherence||Standard Deviation|Mean
2702008|NCT01229527|Secondary|Patient's Satisfaction|The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.|After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone||||units on a scale||Standard Deviation|Mean
2702009|NCT01229527|Primary|Discharge Time, the Time to Reach a Modified Aldrete Score ≥18|Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.|> 0 minutes||||minutes||Inter-Quartile Range|Median
2702010|NCT01229462|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4|Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 4|Intent-to-treat population consisted of all randomized participants.|||mm Hg||Standard Deviation|Mean
2702011|NCT01229449|Secondary|Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication|"Subject's Overall Assessment measured by subject ticking the appropriate box in response to the question 'How effective do you think the study medication is as a treatment for pain?'~Subject's Overall Assessment rated on a five-point ordinal scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, and 5 = Excellent."|At 12 hours|Three subjects from ITT population were excluded from this analysis due to early/late diary assessments.|||Participants|||Count of Participants
2702012|NCT01229449|Secondary|Change From Baseline in Peak Pain Relief (PR)|"Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'~Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete."|0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose|ITT population|||units on a scale||Standard Deviation|Mean
2702013|NCT01229449|Secondary|Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)|"Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'~PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain."|0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose|ITT population|||units on a scale||Standard Deviation|Mean
2702014|NCT01229449|Secondary|Individual Pain Intensity Differences Visual Analogue Scale (VAS)|Pain Intensity (PI) VAS was measured using a horizontal 100-mm VAS ranging 0 mm = 'No Pain' as the left anchor and 100 mm = 'Worst Pain' as the right anchor, labelled by the subject marking the VAS line in the pain assessment questionnaire in response to the instruction 'Please indicate with a line on the scale below your pain at this time.'|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2702015|NCT01229449|Secondary|Individual Pain Intensity Differences (Ordinal)|"Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'~PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain."|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2702016|NCT01229449|Secondary|Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)|"SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.~Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'~Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'"|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2702017|NCT01229449|Secondary|Change From Baseline in AUC of Pain Relief Scores (TOTPAR)|"Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'~Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete."|0-4, 0-6, 0-8 and 0-12 hours|ITT population|||units on a scale*hour||Standard Deviation|Mean
2702018|NCT01229449|Secondary|Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)|Sum of Pain Intensity Difference (SPID) was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Score range: 0mm = No pain and 100mm = Worst pain. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'|0-4, 0-6, 0-8 and 0-12 hours|ITT population|||units on a scale*hour||Standard Deviation|Mean
2702019|NCT01229449|Secondary|Change From Baseline in AUC (0-8h) of SPRID|"SPRID 0-8h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0 mm = No pain and 100 mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.~Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'~Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'"|0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose|ITT population|||units on a scale*hour||Standard Deviation|Mean
2702064|NCT01229410|Primary|Highest Vitreous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.|60 Days|Per Protocol: all subjects with pharmacokinetic data available|||Nanogram/milliliter (ng/mL)|||Number
2702020|NCT01229449|Primary|Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)|"SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.~Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'~Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'"|0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose|Intention-to-treat (ITT) population includes all randomized subjects who took the study medication, completed the baseline efficacy assessments and had at least one post-baseline assessment. Any subjects with treatment administration errors were analyzed according to the treatment to which they were randomized.|||units on a scale*hour||Standard Deviation|Mean
2702021|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 180 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702022|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 90 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 90 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702023|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after fourth injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702024|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702025|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702026|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702027|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702028|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702029|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702030|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702031|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702032|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702033|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702065|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers|||Fold (ratio)||95% Confidence Interval|Number
2702034|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702035|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702036|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702037|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. ‘N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702038|NCT01229436|Secondary|Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. ‘Number of participants’ analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.|||days||Full Range|Median
2702039|NCT01229436|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.|||events||Full Range|Median
2702040|NCT01229436|Secondary|Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
2702066|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroconversion rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
2702041|NCT01229436|Secondary|Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score|URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.|Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||units on a scale||Full Range|Median
2702042|NCT01229436|Secondary|Time to Recovery|Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.|Up to Day 30 after first, second and third injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||days||95% Confidence Interval|Median
2702043|NCT01229436|Secondary|Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire|Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).|C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||days||Full Range|Median
2702044|NCT01229436|Secondary|Number of Days of Concomitant Pain Medication Usage|Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.|||days||Full Range|Median
2702045|NCT01229436|Other Pre-specified|Number of Participants With Anti-Drug Antibody (ADA)|Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).|Screening, Follow-up Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
2702046|NCT01229436|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]).|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.|||participants|||Number
2702047|NCT01229436|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.|||participants|||Number
2702048|NCT01229436|Secondary|Number of Participants With Type of Concomitant Pain Medication Used|Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.|||participants|||Number
2702049|NCT01229436|Secondary|Physician Global Assessment of Treatment Satisfaction and Disease Severity|Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician's rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.|Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
2702050|NCT01229436|Secondary|Participant Global Assessment of Treatment Satisfaction and Disease Severity|Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.|Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
2702051|NCT01229436|Secondary|Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702052|NCT01229436|Secondary|Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702053|NCT01229436|Secondary|Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection|TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection|FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.|||degrees|Participants|Full Range|Median
2702067|NCT01229397|Secondary|Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability||Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary|Safety population, all vaccinated subjects|||participants|||Number
2702068|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroprotection rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
2702131|NCT01228591|Secondary|Contact Lens Comfort Using Contact Lens User Experience (CLUE)|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
2702054|NCT01229436|Secondary|Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702055|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for First Injection|TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first injection|Full analysis set(FAS):participants who received at least (>=)1 injection of Xiapex,had >=1 post-injection efficacy assessment(goniometric/participant-reported). 'N’(number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
2702056|NCT01229423|Secondary|Percentage of Subjects Satisfied With Treatment at Week 20|"Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question Which best describes your satisfaction with LATISSE®? Responses were very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied. Satisfied is defined as responses of very satisfied and satisfied."|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Percentage of Subjects|||Number
2702057|NCT01229423|Secondary|Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20|"Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question Overall how satisfied are you with your eyelashes? Responses were based on a 5-point scale (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied). Improvement in subject satisfaction is defined as a 1-point increase from baseline."|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Percentage of Subjects|||Number
2702058|NCT01229423|Secondary|Change From Baseline in Eyelash Intensity (Darkness) at Week 20|Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Units on a Scale||Standard Deviation|Mean
2702059|NCT01229423|Secondary|Change From Baseline in Eyelash Thickness at Week 20|Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Millimeters Squared (mm^2)||Standard Deviation|Mean
2702060|NCT01229423|Secondary|Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20|Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Percentage of Subjects|||Number
2702061|NCT01229423|Primary|Change From Baseline in Eyelash Length at Week 20|Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Millimeter (mm)||Standard Deviation|Mean
2702062|NCT01229410|Secondary|Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)|Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.|60 Days|Per Protocol: all subjects with qualified pharmacokinetic samples|||Percentage of Patient Samples|Participants||Number
2702063|NCT01229410|Secondary|Highest Aqueous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.|60 Days|Per Protocol: all subjects with pharmacokinetic data available|||Nanogram/milliliter (ng/mL)|||Number
2702102|NCT01229111|Secondary|Identification of Factors That Predict Survival|Factors that predict survival will be identified by Cox model or extended Cox model.|Up to three years|Statistically, due to the small sample size, analysis could not be done||||||
2702069|NCT01229371|Primary|Immunogenicity - Seroconversion Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
2702070|NCT01229371|Primary|Immunogenicity - Seroprotection Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
2702071|NCT01229371|Secondary|Number of Participants With Local and Systemic Adverse Events|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects|||participants|||Number
2702072|NCT01229371|Primary|Immunogenicity - Geometric Mean Titer Fold Increase From Baseline|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase||95% Confidence Interval|Number
2702073|NCT01229267|Other Pre-specified|Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to 118 days)|The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.|||Percentage of participants|||Number
2702074|NCT01229267|Primary|Percentage of Participants With One or More Serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to 118 days)|The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.|||Percentage of participants|||Number
2702075|NCT01229267|Secondary|Incidence of Postherpetic Neuralgia|Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.|Up to 6 months after the onset of HZ rash (up to approximately 5 years)|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2702076|NCT01229267|Secondary|Incidence of Herpes-Zoster Complications|The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.|Up to 6 months after onset of HZ (up to approximately 5 years)|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2702077|NCT01229267|Secondary|Incidence of Moderate to Severe Herpes-Zoster-Associated Pain|Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.|Up to 6 months after onset of HZ (up to approximately 5 years)|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2702078|NCT01229267|Primary|Incidence of Confirmed Herpes-Zoster|Clinical criteria for suspected Herpes-Zoster (HZ) cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.|Up to approximately 5 years|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
2702079|NCT01229254|Secondary|Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing|Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in amiodarone, low and high weight groups|Days 14, 18, and 21 of the PK period|Full Analysis Set population, which includes all patients who received at least one dose of study treatment within 24 hours prior to steady-state (SS) blood sampling, were ≥ 90% compliant with treatment, and had at least one post SS sample. The endpoint was to summarize the SS C12 hr concentration across treatments and time points as a single arm.|||ng/mL||90% Confidence Interval|Geometric Least Squares Mean
2702080|NCT01229254|Primary|Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing|Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in low and high weight groups|Days 14, 18, and 21 of the PK period|Per protocol analysis set, which includes all allocated patients who received at least one dose of study treatment and who were ≥ 90% compliant with study treatment, took study treatment within 24 hours prior to steadystate blood sampling, had at least two post steady-state blood samples collected, and not on amiodarone.|||ng/mL||90% Confidence Interval|Geometric Least Squares Mean
2702081|NCT01229228|Primary|Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0|"Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|Over 0 to 12 Hours||||units on a scale||95% Confidence Interval|Least Squares Mean
2702082|NCT01229176|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|"Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.~Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.~Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants)."|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population.|||participants|||Number
2702083|NCT01229176|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2702084|NCT01229176|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2702085|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set|||percentage of subjects||95% Confidence Interval|Number
2702086|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.|||percentage of subjects||95% Confidence Interval|Number
2702087|NCT01229150|Other Pre-specified|Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1|Number of participants who underwent mutational analysis for EGFR, MEK 1, BRAF, and LKB1 was to be assessed by polymerase chain reaction (PCR).|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.||||||
2702088|NCT01229150|Other Pre-specified|Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET|Number of participants with over expression of EGFR and c-MET was to be assessed by fluoresense in situ hybridization (FISH).|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.||||||
2702089|NCT01229150|Other Pre-specified|Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing|p-ERK, p-AKt and PTEN protein expression testing was to be assessed by immunohistochemistry.|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.||||||
2702090|NCT01229150|Other Pre-specified|Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells|Fold change from cycle 1 day 1 was determined by programmed cell death-1 (PD-1) expression on CD8+ T cells measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
2702103|NCT01229111|Secondary|Estimation of Overall Survival|Time of overall response|Up to 3 years|Patients that received treatment.|||Months||95% Confidence Interval|Median
2702091|NCT01229150|Other Pre-specified|Change in Programmed Cell Death-1 (PD-1) Expression on Tregs|Fold change from cycle 1 day 1 was determined by the PD-1 expression level on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
2702092|NCT01229150|Other Pre-specified|Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs|The fold change from cycle 1 day 1 was determined by the level of CTLA-4 expression on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
2702093|NCT01229150|Other Pre-specified|Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs|Fold change from cycle 1 day 1 was determined by TIM-3 expression level on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
2702094|NCT01229150|Other Pre-specified|Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate|Changes in a tumor's MIB-1 (Ki-67) rate was to be assessed by immunohistochemistry.|At enrollment|Tumor MIB-1 (Ki-67) rate testing was not done because it was too costly.||||||
2702095|NCT01229150|Secondary|Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes|Level of p-ERK was measured by the median channel cumber of fluorescence intensity. Data are relative to the level before therapy begins(C1D1).Then we see what the level was after therapy & compare. Every value after therapy is compared to pre-therapy, & every patient is their own control. To do that, we make C1D1 equal to 1 for every patient & then compare the pERK level after therapy by looking at the fold change in pERK level.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|Re: number of participants analyzed: Samples were either not drawn or could not be located. WT KRAS 1/WT KRAS 2 are missing because the effect of treatment on the Ras-Raf-MEK-ERK pathway as measured by a reduction in phosphorylated extracellular signal-regulated kinases (p-ERK) in lymphocytes was evaluated in patients with KRAS-mutated tumors only.|||participants|||Number
2702096|NCT01229150|Secondary|Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response|First the number of T cells that are CD4+ is determined by staining with an antibody to CD4 and measured in a flow cytometer. Then the number of Th17+ cells is determined by staining with an antibody to IL-17 and measured in a flow cytometer. Then the percentage of CD4+ cells that are also Th17 cells is determined as a simple ratio, i.e. Th17cells/CD4 cells. This ratio is reported here for each category of KRAS mutation status for whom we had patients.|Pretreatment - Cycle 1 Day 1|No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. For all other cohorts, the numbers analyzed indicates some samples were either not drawn or could not be located.|||Percentage of Th17 in CD4+T Cells||Standard Deviation|Mean
2702097|NCT01229150|Secondary|Overall Survival|Time between the first day of treatment to the time of death.|Up to 26 months||||Months||95% Confidence Interval|Median
2702098|NCT01229150|Secondary|Percentage of Participants With Disease Control/Stabilization|Disease control/stabilization is the percentage of participants with partial response (PR) + complete response (CR) + stable disease (SD). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions.), taking as reference the smallest sum diameters.|3 cycles or up to 84 days||||percentage of participants||95% Confidence Interval|Number
2702099|NCT01229150|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|42 months|The combination of toxicities allows for a more robust understanding of the combined therapy toxicities. The dosage of the combination of erlotinib plus AZD6244 was the same whether the pt has a KRAS mutation versus KRAS wild type. KRAS is a molecular mutation and does not change whether or not a pt has toxicities to the combination of therapies.|||Participants|||Number
2702100|NCT01229150|Primary|Objective Response|Objective response is complete response + partial response. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 37 months|There were no partial or complete responses in the KRAS mut 1 arm.|||participants|||Number
2702101|NCT01229150|Primary|Progression Free Survival|Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that's the smallest on study). In addition to the relative increase of 20% of at least 5mm. (Note: the appearance of one or more lesions is also considered progression).|2.1 to 4 months||||Months||95% Confidence Interval|Median
2702104|NCT01229111|Secondary|Progression Free Survival|Time in months that evaluable subjects survived progression free|Up to 3 years|Patients that were evaluable for response|||Months||95% Confidence Interval|Median
2702106|NCT01229111|Primary|The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|The number of patients with a Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 years|Patients that were evaluable|||participants|||Number
2702107|NCT01228968|Secondary|Subcutaneous Fat Volume With Manual Segmentation|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with the older manual segmentation technique.|five minutes||||cubic centimeters||Standard Deviation|Mean
2702108|NCT01228968|Primary|Visceral Fat Volume With Manual Segmentation|This is the measure of visceral fat found with our older manual segmentation method|five minutes||||cm3||Standard Deviation|Mean
2702109|NCT01228968|Primary|Visceral Fat Volume With Automated Analysis|This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program.|five minutes||||cubic centimeters||Standard Deviation|Mean
2702110|NCT01228968|Secondary|Subcutaneous Fat Volume With Automated Analysis|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with new automated anatomical segmentation software.|five minutes||||cubic centimeters||Standard Deviation|Mean
2702111|NCT01228929|Primary|Change in Ocular Surface Temperature (OST)|Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.|baseline and 30 minutes||||degree celsius|Participants|Standard Deviation|Mean
2702112|NCT01228903|Other Pre-specified|Change in Serum Uric Acid Levels From Baseline to Week 12|Serum uric acid levels were measured both at baseline and after 12 weeks|Baseline and 12 weeks||||mg/dL||Standard Deviation|Mean
2702113|NCT01228903|Secondary|Change in Oxidized Low Density Lipoprotein From Baseline to Week 12||Baseline and 12 weeks||||u/L||Standard Deviation|Mean
2702114|NCT01228903|Secondary|Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12||Baseline and 12 weeks|-4.7|||pg/mL||Standard Deviation|Mean
2702115|NCT01228903|Secondary|Change in Serum Interleukin-6 From Baseline to Week 12||Baseline and 12 weeks||||pg/mL||Standard Deviation|Mean
2702116|NCT01228903|Secondary|Change in C-reactive Protein From Baseline to Week 12||Baseline and 12 weeks||||mg/L||Standard Deviation|Mean
2702117|NCT01228903|Primary|Change in Endothelial Dependent Dilation From Baseline to Week 12|Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12|Baseline and 12 weeks||||% change||Standard Deviation|Mean
2702118|NCT01228747|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.|Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.|||participants|||Number
2702119|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.|||participants|||Number
2702120|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.|||participants|||Number
2702121|NCT01228747|Secondary|The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline."|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure in Evaluation Period.|||Percentage Change||Standard Deviation|Mean
2702132|NCT01228591|Primary|Visual Acuity at Time of Initial Fit|Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.|After 10-15 minutes of lens wear|Analysis is conducted on those were enrolled and completed the trial.|||LogMAR|eyes|Standard Deviation|Mean
2702313|NCT01227785|Primary|Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|73 CRT-D and 44 ICD patients had data available at pre-discharge visit.|||milli volt (mV)||Standard Deviation|Mean
2702122|NCT01228747|Primary|Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.|||Percentage Change||Standard Deviation|Mean
2702123|NCT01228734|Secondary|Number of Subjects With Curative Surgery of Liver Metastases|The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.|Baseline up to 333 weeks|"MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized. Here Number Analyzed signifies those subjects who were evaluable for the specified categories."|||subjects|||Number
2702124|NCT01228734|Secondary|Time to Treatment Failure (TTF)|TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.|Baseline up to 333 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||months||95% Confidence Interval|Median
2702125|NCT01228734|Secondary|Best Overall Response Rate (ORR)|The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.|Baseline up to 333 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||percentage of subjects||95% Confidence Interval|Number
2702126|NCT01228734|Secondary|Overall Survival (OS) Time|OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.|Baseline up to 333 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||months||95% Confidence Interval|Median
2702127|NCT01228734|Primary|Progression Free Survival (PFS) Time|PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|Baseline up to 333 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||months||95% Confidence Interval|Median
2702128|NCT01228591|Secondary|Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)|Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|Baseline|Subjects analyzed included only those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
2702129|NCT01228591|Secondary|Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)|Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.|Baseline|Analysis was on those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
2702130|NCT01228591|Secondary|Subject Reported Vision Using Contact Lens User Experience (CLUE).|Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
2720782|NCT01093586|Primary|Overall Survival|Number of participants alive at 180 days post engraftment.|On day +180|All participants that went on study, whether completing engraftment or not.|||Participants|||Count of Participants
2702133|NCT01228591|Primary|Visual Acuity One Week After Lens Wear|Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.|1 week|Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.|||LogMAR|eyes|Standard Error|Least Squares Mean
2702134|NCT01228435|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDRA coding terms and separate tabulations will be produced for treatment-emergent adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity. A treatment-emergent adverse event is defined as an adverse event that was deemed to be related to the study intervention.|2 years||||participants|||Number
2702135|NCT01228435|Primary|Response Rate|The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated separately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.|2 years||||participants|||Number
2702136|NCT01228318|Post-Hoc|CD4 T Cell Count|Immunologic response measured by CD4 T cell count by treatment arm and weeks on study.|Baseline, Week 144|This analysis includes participants with a CD4 count measurement at the time points indicated.|||cells/uL||Standard Deviation|Mean
2702137|NCT01228318|Post-Hoc|Percentage of Participants With Virological Suppression by Week 144|The percentage of participants achieving viral load suppression by study week 144. Virologic suppression was defined as HIV RNA polymerase chain reaction (PCR) (viral loads) less than 50 copies per mL.|Week 144|All participants are included in this analysis, using all available measurements of viral load.|||percentage of participants|||Number
2702138|NCT01228318|Other Pre-specified|Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA)|Development of osteoporosis was assessed by examining bone mineral density (BMD) by DXA scan. Baseline-adjusted means of DXA scan Z-scores are presented for the lumbar spine (L1-L4), left hip, and femur neck. The baseline-adjusted BMD mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Bone density Z-scores tell how close to the average that a person is (adjusted for age, race, and gender). A Z-score of 0 means the value matches that of the average person. Z-score values below 0 indicate lower than average bone density while values above 0 indicate higher bone density than the average person.|Baseline, Week 144|This analysis includes participants who had a DXA scan performed at baseline and at least one additional study visit.|||Z score||95% Confidence Interval|Least Squares Mean
2702139|NCT01228318|Secondary|Baseline-Adjusted Means of Osteocalcin|Osteocalcin was evaluated to examine the inhibitory effect of single dose zoledronic acid on HAART associated changes in markers of bone turnover. Osteocalcin is released from bone during resorption and higher levels in the circulatory system indicate increased bone turnover. HIV-infected individuals are expected to have increased bone resorption. The baseline-adjusted osteocalcin mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Baseline-adjusted means of osteocalcin at week 144 are presented.|Baseline, Week 144|Participants with osteocalcin measurements at Week 144 are included in this analysis.|||ng/ml||95% Confidence Interval|Least Squares Mean
2702140|NCT01228318|Primary|Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels|Serum C-terminal telopeptide of collagen (CTx) levels through week 144 were examined by evaluating the baseline-adjusted means. The baseline-adjusted CTx mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at each scheduled clinical visit. The expected outcome is that HIV-infected individuals will display increased indices of bone resorption (CTx) as a result of diminished bone mineral density (BMD). Lower CTx values indicate that better maintenance of bone mineral density.|Baseline, Week 12 through Week 144|Participants with CTx measurements at the indicated week are included in this analysis.|||ng/ml||95% Confidence Interval|Least Squares Mean
2702141|NCT01228175|Primary|Cigarettes Per Smoking Day|"The number of cigarettes smoked were assessed only on a smoking day, i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks."|up to 36 weeks||||Cigarettes per smoking day||Standard Deviation|Mean
2702142|NCT01228149|Secondary|Number of Suture Lyses|Number of suture lyses at visit 5 (week 12 after surgery)|week 12|Intention-to- treat population|||Participants|||Count of Participants
2702143|NCT01228149|Secondary|Change in Conjunctival Redness|"Conjunctival redness (ORA Scale) evaluated from 16 up to 28 days (time window) prior surgery and 1 day prior surgery. The investigator compares patient's study eye with a set of reference photos showing various degrees of redness. Redness was scored on a scale of none, mild, moderate, severe and very severe. Absolute and relative frequencies of visit 1 and 2 were compared descriptively."|24 weeks|ITT population|||Participants|||Count of Participants
2702144|NCT01228149|Secondary|Change in Quality of Life|"Change in quality of life measure by a certified National Eye Institute Visual Functioning Questionnaire containing 25 questions (NEI VFQ-25).Patients tick a score at every question to present their visual functioning (usually from 1-5 or 1-6 in which 1 is best and 6 worse). Every single item/score is transformed to a scale between 0 and 100 (0 best, 100 worse). For the total score, the mean of all transformed scores/items is calculated.~NEI VFQ 25 Quality of Life Questionnaire composite score at V5 (week 12 after surgery).~Outcome shows mean of differences and 95% confidence intervall."|12 weeks|ITT Population|||scores on a scale||Standard Deviation|Mean
2702163|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 12|"The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline."|Baseline and Week 12|Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE|||Percentage of Participants|||Number
2720851|NCT01092832|Secondary|Time to Death||Baseline up to 1 month follow-up|No participants died within the safety reporting period, therefore time to death was not applicable.||||||
2702145|NCT01228149|Secondary|Filtration Bleb Classification|"Filtration bleb classification (Grehn) in both Groups 1 week, 4 weeks, 12 weeks and 24 week after surgery.~For classification the following criteria were evaluated and scored as described below:~vascularisation (0=None, 1=mild, 2=a few corkscrew vessels)~identifiability (0=no borders to sides; 1=demarcation nasally or temporally; 2= demarcation to both sides; 3= encapsulated)~Thickness (0= a least 3mm; 1=2mm; 2= 1mm; 3=flat)~Microcysts (0=no; 1= yes)~Transparency (0= highly transparent; 2=moderate; 2=not transparent)~Mobility (0= yes; 1= no)~Leakage (0=yes, 1=no)~For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only."|24 weeks|PP Population|||Participants|||Count of Participants
2702146|NCT01228149|Secondary|Change in IOP Between Visit 1 and 2|Change in IOP between Visit 1 (Screening visit 16 to 28 day prior trabeculectomy) and Visit 2 (1 day before trabeculectomy). Outcome shows mean of differences and 95% confidence intervall.|28 days|PP Population|||mmHg||95% Confidence Interval|Mean
2702147|NCT01228149|Secondary|Ocular Hypotension Rate|Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension|24 weeks|PP Population|||Participants|||Count of Participants
2702148|NCT01228149|Secondary|Number of Necessary 5-Fluorouracil (5FU) Injections|Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12|12 weeks|PP Population (n=58)|||number of injections||Standard Deviation|Mean
2702149|NCT01228149|Secondary|Number of Needling|number of patients requirering needling|12 weeks|Patients of the PP population|||Participants|||Count of Participants
2702150|NCT01228149|Primary|Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP|Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery|12 weeks|In total 62 patients were randomized, 30 to COSOPT-S®, 32 to DIAMOX+Dexa edo® (intention-to-treat (ITT) population. Per-protocol (PP) population (treated >8 days and did not take any medication that interfered with the study): n=58 patients: 27 p. in COSOPT-S®, 31 p. in DIAMOX+Dexa edo®. Analysis population: patients who completed the study n=53|||mmHg||95% Confidence Interval|Mean
2702151|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype||Day 1 of study treatment||||hours||Full Range|Median
2702152|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype||Day 1 of study treatment||||Hours||Full Range|Median
2702153|NCT01228084|Secondary|Half-life of Sulforaphane (SFN) in Blood||Day 1 of study treatment||||hours||Full Range|Median
2702154|NCT01228084|Secondary|Incidence of Grade 3 or Higher Treatment Related Toxicity|Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane|Continually through study and 14-30 days after last drug dose.||||participants|||Number
2702155|NCT01228084|Secondary|Proportion of Patients Whose PSA Levels Have Not Doubled||While on treatment with sulforaphane (less than or equal to 20 weeks.)||||percentage of participants|||Number
2702156|NCT01228084|Secondary|Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)||PSA measured every 28 days while on study treatment, an average of 5 months||||percent change||Full Range|Median
2702157|NCT01228084|Secondary|Percent Change in PSA From Baseline to Final Measured Value at End of Study|To determine the percentage change in PSA from baseline to the final measured value at the end of study.|Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)||||Percent change||Full Range|Median
2702158|NCT01228084|Primary|Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels|To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer.|Less than or equal to 20 weeks of sulforaphane treatment.||||percentage of participants|||Number
2702159|NCT01228071|Primary|Gel Drying Time|"Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3× 5 postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF."|1 day; drying time measured following gel application on Day 14|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.|||minutes||95% Confidence Interval|Median
2702160|NCT01228071|Primary|Time to Steady State (SS)|Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.|14 days|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.|||days||95% Confidence Interval|Median
2702161|NCT01228071|Primary|Time to Target Eugonadal Range|The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.|24 hours|Of the 31 subjects in the PK population, 7 subjects were not included in the analysis for time to eugonadal range. Five (5) subjects had total testosterone serum concentrations of ≥300 ng/dL at Visit 2 (baseline, time 0) and 2 subjects had total testosterone serum concentrations that never reached 300 ng/dL.|||hours||95% Confidence Interval|Median
2702162|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 24|"The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of Improved, Unchanged or Worsened when compared to baseline."|Baseline and Week 24|Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE|||Percentage of Participants|||Number
2702314|NCT01227785|Primary|Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients|implant|74 CRT-D and 45 ICD patients had data available at implant|||milli volt (mV)||Standard Deviation|Mean
2702164|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 24|Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
2702165|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24|Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
2702166|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24|Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
2702167|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 24|Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
2702168|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 12|Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels.|||mg/dL||Standard Deviation|Mean
2702169|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels.|||mg/dL||Standard Deviation|Mean
2702170|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.|||mg/dL||Standard Deviation|Mean
2702171|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 12|Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.|||mg/dL||Standard Deviation|Mean
2702172|NCT01228019|Primary|Percentage of Participants With Adverse Drug Reactions|An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data|||Percentage of Participants|||Number
2702173|NCT01228019|Primary|Percentage of Participants With Any Adverse Experience|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data|||Percentage of participants|||Number
2702174|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702175|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702176|NCT01227993|Secondary|Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702177|NCT01227993|Secondary|Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702178|NCT01227993|Secondary|Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702179|NCT01227993|Secondary|Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702180|NCT01227993|Secondary|Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702181|NCT01227993|Secondary|Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years|||||||
2702182|NCT01227993|Secondary|Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms.|Baseline and 2 years||||µg||Standard Deviation|Mean
2702183|NCT01227993|Secondary|Change in Serum DHT Levels at Two Years Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum.|Baseline and 2 years||||pg/mL||Standard Deviation|Mean
2702184|NCT01227993|Secondary|Change in Serum Testosterone Levels at Two Years Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum.|Baseline and 2 years||||ng/dL||Standard Deviation|Mean
2702185|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year||||ETDRS letters|Participants|Standard Deviation|Mean
2702186|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year||||ETDRS letters|Participants|Standard Deviation|Mean
2702187|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years||||ETDRS letters|Participants|Standard Deviation|Mean
2702188|NCT01227993|Primary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years||||ETDRS letters|Participants|Standard Deviation|Mean
2702189|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Mean
2702190|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702191|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702192|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702193|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702194|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702195|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702196|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702315|NCT01227785|Primary|Clinical Performance at1-month for RA Sensing Amplitude|RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1-month|53 CRT-D and 11 ICD patients had data available at 1-month visit.|||milli volt (mV)||Standard Deviation|Mean
2720852|NCT01092832|Secondary|All-Cause Mortality - Number of Participant Deaths||Day 28 and 1 Month Follow-up|Safety population|||participants|||Number
2702197|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702198|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702199|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702200|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702201|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702202|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Mean
2702203|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2702204|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Mean
2702205|NCT01227967|Secondary|28-day Mortality|Number of deaths|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||participants|||Number
2702206|NCT01227967|Secondary|Percentage of Participants Who Required Hospitalization.|The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants analyzed||95% Confidence Interval|Number
2702207|NCT01227967|Secondary|Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen|Percentage of participants who required new or increased use of supplemental oxygen|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants analyzed|||Number
2702208|NCT01227967|Secondary|Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.|Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.|||percentage of participants analyzed|||Number
2702209|NCT01227967|Secondary|Percentage of Participants With Clinical Failure at Day 5|Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants analyzed|||Number
2702210|NCT01227967|Secondary|Time to Return of Physical Function to Pre-illness Leve|Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2702211|NCT01227967|Secondary|Time to Return to Pre-influenza Function|Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2702212|NCT01227967|Secondary|Time to Feeling as Good as Before the Onset of the Influenza Illness|Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2702213|NCT01227967|Secondary|Time to Resolution of All Symptoms AND Fever|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2702214|NCT01227967|Secondary|Time to Absence of Fever|Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2702215|NCT01227967|Secondary|Time to Alleviation of Influenza Clinical Symptoms.|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2702216|NCT01227967|Secondary|Number of Participants Shedding Virus|Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).|At day 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
2702217|NCT01227967|Secondary|qPCR Viral Shedding|Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)|At Day 0, 3 and 7|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Log10 copies/mL||Inter-Quartile Range|Median
2702316|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Sensing Amplitude|RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|55 CRT-D and 11 ICD patients had data available at pre-discharge visit.|||milli volt (mV)||Standard Deviation|Mean
2702218|NCT01227967|Secondary|Number of Participants by Virus Detection Status|Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ|At Day 0, 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
2702219|NCT01227967|Primary|Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs|The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.|At Day 3|The population analyzed was restricted to the 407 participants who had a confirmed positive test for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC003. 13 participants (5 in the Combination Therapy and 8 in the Oseltamivir Monotherapy) had missing endpoint samples so were excluded from the analysis.|||percentage of participants analyzed|||Number
2702220|NCT01227954|Secondary|ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function|Per the protocol, the feasibility of the proposed translational studies were to be assessed following completion of accrual and sample collection. The decision was made not to pursue this outcome measure. No assays were performed and no data were collected for this Outcome Measure|Baseline and 4 months from start of treatment|||||||
2702221|NCT01227954|Secondary|The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment|For each patient the highest grade adverse event related to treatment was calculated. Those with their highest grade of 3 or higher were counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to 12 months from start of treatment|Eligible patients who started study treatment|||Participants|||Count of Participants
2702222|NCT01227954|Secondary|Progression-free Survival|Progression (radiographic) is defined as an increase in perpendicular bidimensional tumor area (at lease 50% for lesions < 1cm, at least 25% for lesions >=1cm) for any of the 1-3 tracked brain metastases, or the appearance of any new brain metastasis on a follow-up MRI. Progression-free survival was calculated instead of time to progression. Progression-free survival time was measured from registration to the date of progression, death, or last known follow-up (censored). The Kaplan-Meier method used to determine median time (along with 95% confidence intervals).|Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment|||months||95% Confidence Interval|Median
2702223|NCT01227954|Secondary|Overall Survival|Overall survival was measured from registration to the date of death or last known follow-up (censored). Kaplan-Meier estimator was used to median survival time and 95% confidence interval.|Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment|||months||95% Confidence Interval|Median
2702224|NCT01227954|Secondary|Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)|The Barthel Index of Activities of Daily Living (ADL) is a 10-item assessment. Patient scores on the ADL range from 0 to 20 with lower scores indicating declining functional status.|Baseline and 4 months from start of treatment|Eligible patients who started treatment and completed at least one ADL assessment|||units on a scale||Full Range|Median
2702225|NCT01227954|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|The FACT-Br is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, 0=Not a lot to 4=Very much. All subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range 0-108 for FACT-G total, 0-28 for physical, social, functional subscales, 0-24 for emotional subscale, 0-76 for brain subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale requires >= 50% of items to be completed while the overall response rate must be > 80%. If items are missing, the subscale scores can be prorated.|Baseline and 4 months from start of treatment|Eligible patients who started treatment and completed at least one FACT-Br assessment|||units on a scale||Full Range|Median
2702226|NCT01227954|Secondary|Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)|The score is the arcsine of the square root of the proportion of correct responses. A higher score indicates a better performance. Each patient served as her or his own control, and the percent change in OCLT score from baseline to 4 months was calculated as 100*[(baseline score - 4 month score)/ baseline score].|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data|||percent change||95% Confidence Interval|Mean
2702227|NCT01227954|Secondary|Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)|The score is the total number of correct responses made in remembering the list on three consecutive trials in a single session. A higher score indicates a better performance. Each patient served as her or his own control, and the percent change in ISLT score from baseline to 4 months was calculated as 100*[(baseline score - 4 month score)/ baseline score].|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data|||percent change||95% Confidence Interval|Mean
2702283|NCT01227824|Secondary|Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.|Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.|Week 48 and Week 96|ITT-E Population|||Participants|||Number
2702228|NCT01227954|Primary|Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)|Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100*[(baseline score - 4 month score)/ baseline score]|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data|||percent change||95% Confidence Interval|Mean
2702229|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. The cut off for these data was October 12, 2012.|||participants|||Number
2702230|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.|||participants|||Number
2702231|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.|||participants|||Number
2702232|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)|12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the faster the heart rate the shorter the QTc. If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012.|||participants|||Number
2702233|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline|Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014.|||participants|||Number
2702234|NCT01227928|Secondary|Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE|An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
2702235|NCT01227928|Secondary|Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
2702236|NCT01227928|Secondary|Number of Participants With the Indicated On-therapy Grade 3-5 AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
2702237|NCT01227928|Secondary|Number of Participants With Any Grade 3 or 4 AE|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
2702238|NCT01227928|Secondary|Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
2702239|NCT01227928|Secondary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
2702240|NCT01227928|Secondary|Number of Participants With Any Dose Reduction or Any Dose Interruption|Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.|||participants|||Number
2702299|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Impedance|RV pacing impedance results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant|||Ohms||Standard Deviation|Mean
2702241|NCT01227928|Secondary|PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria|"PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as Progressed per RECIST if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as Progressed per CA-125 if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment."|From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)|ITT Population. The cut off for these data was October 12, 2012.|||months||95% Confidence Interval|Median
2702242|NCT01227928|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.|From randomization until death due to any cause (average of 29.4 months)|ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.|||months||95% Confidence Interval|Median
2702243|NCT01227928|Primary|Progression-free Survival (PFS)|PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.|From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)|Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.|||months||95% Confidence Interval|Median
2702244|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2702245|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2702246|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2702247|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2702248|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Epilepsy-related Worry|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2702249|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2702257|NCT01227902|Secondary|Percent Change From Baseline in Partial-onset Seizure Frequency|Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population|||percent change||Standard Deviation|Mean
2702250|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2702251|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2702252|NCT01227902|Secondary|Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2702253|NCT01227902|Secondary|Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time|"Participants were asked the following question daily: Did you miss any time from work or school in the last 24 hours due to epilepsy? Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2702254|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I wanted to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2702255|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I needed to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2702256|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry|"Participants were asked the following question daily: How would you rate your epilepsy-related worry over the last 24 hours? The original possible responses were 0-10, with 0=No worry and 10=Worst worry imaginable. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average - Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2702258|NCT01227902|Secondary|Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline|The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population|||participants|||Number
2702259|NCT01227902|Secondary|Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency|Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population|||participants|||Number
2702260|NCT01227902|Primary|Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline|The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase.|From Baseline through Week 20 (Day 140)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants in the Safety Population (all participants who took at least one dose of investigational product) who provided at least one post-Baseline efficacy assessment|||participants|||Number
2702261|NCT01227889|Secondary|Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay|Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Clinical Trial Assay (CTA) to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. Multiple specimen per participant were analyzed.|Screening|V600E positive participants screened for BREAK-3 study|||Percent agreement||95% Confidence Interval|Number
2702262|NCT01227889|Secondary|Number of Participants With Non-melanoma Skin Lesions: Randomized Phase|Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.|From Screening until study completion or discontinuation from the study (up to 9.9 months)|Safety Population: all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized|||participants|||Number
2702263|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Crossover Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 6.4 months)|Crossover Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||Months||95% Confidence Interval|Median
2702264|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Crossover Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (up to 6.4 months)|Crossover Treatment Population. At the time data were analyzed for overall response, only 37 participants had crossed over from DTIC treatment to GSK25118436 treatment.|||participants|||Number
2702279|NCT01227824|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||log10 c/mL||Standard Deviation|Mean
2702280|NCT01227824|Secondary|Change From Baseline in Plasma HIV-1 RNA Over Time|Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||log10 c/mL||Standard Deviation|Mean
2702265|NCT01227889|Secondary|Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase|PFS2 is defined as the time from the first dose of GSK2118436, in participants randomized to DTIC who crossed over to GSK2118436 after initial progression, to the earliest date of radiographic or photographic disease progression or death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time from first dose of GSK2118436 in participants who crossover after initial progression to the earliest date of radiographical or photographical PD or death due to any cause (up to 6.4 months)|Crossover Treatment Population: the subset of participants who were randomized to the DTIC arm, and who elected at the point of disease progression to receive GSK2118436. Only participants who received at least one dose of GSK2118436 were included in the Crossover Treatment Population.|||Months||95% Confidence Interval|Median
2702266|NCT01227889|Secondary|Duration of Response as Assessed by an Independent Radiologist: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. NA indicates that data is not available.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 7.4 months)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||Months||95% Confidence Interval|Median
2702267|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 65.6 weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||Months||95% Confidence Interval|Median
2702268|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an independent radiologist per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 12.0 weeks)|ITT Population|||participants|||Number
2702269|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 6.6 weeks)|ITT Population|||participants|||Number
2702270|NCT01227889|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)|ITT Population|||Months||95% Confidence Interval|Median
2702271|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|ITT Population|||Months||95% Confidence Interval|Median
2702272|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered|||Months||95% Confidence Interval|Median
2702273|NCT01227824|Secondary|Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG|The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.|Week 4, Week 24, and Week 48|PK Concentration Population.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2702274|NCT01227824|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.|Week 4, Week 24, and Week 48|PK Concentration Population|||Micrograms*hour per milliliter(µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2702275|NCT01227824|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. Safety Population: all participants who received at least one dose of investigational product|From Baseline until Week 96|Safety Population.|||Participants|||Number
2702276|NCT01227824|Secondary|Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.|From Baseline until Week 96|ITT-E Population|||Participants|||Number
2702277|NCT01227824|Secondary|Absolute Values in CD4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||cells/mm^3||Standard Deviation|Mean
2702278|NCT01227824|Secondary|Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2702281|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.|Week 48 and Week 96|ITT-E Population|||Participants|||Number
2702284|NCT01227824|Primary|Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48|Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.|Baseline up to Week 48|ITT-E Population.|||Percentage of participants|||Number
2702285|NCT01227785|Primary|Wanded Telemetry Issues at Pre-discharge Follow-up|The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.|Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit|118 was the total number of questionnaires completed and available from the PI for analysis.|||issues|||Number
2702286|NCT01227785|Primary|Spontaneous Episode Conversion Success Rate at 3 Months|Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.|3-month|Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported.|||percentage of successful conversions|Participants||Number
2702287|NCT01227785|Primary|Induced Episode Detection Times at 3 Months|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|3-month|Of the 6 CRT-D and 3 ICD patients with available data that had succesful conversion after induced VT/VF episodes, the mean time was determined at 3 months|||seconds||Standard Deviation|Mean
2702288|NCT01227785|Primary|Induced Episode Detection Times at 1-month|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|1-month|Of the 1 CRT-D and 1 ICD patients that underwent induced VT/VF at 1month, the mean time for successful conversion was reported.|||seconds||Standard Deviation|Mean
2702289|NCT01227785|Primary|Induced Episode Detection Times at Implant|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|implant|Of the 30 CRT-D and 22 ICD patients with induced VT/VF episodes, the mean time required for conversion was reported for all available data|||seconds||Standard Deviation|Mean
2702290|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 3-months|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|3-month|Of the 6 CRTD and 3 ICD patients that had induced VT/VF episodes at 3-month follow-up, the number of those that were converted successfully was reported in %|||percentage of successful conversions|||Number
2702291|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 1-month|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|1-month|Of all patients that experienced an induced VT/VF episode at 1-month, the number that had successful conversions was reported for both CRT-D and ICD patients.|||percentage of successful conversions|||Number
2702292|NCT01227785|Primary|Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|implant|Of the 30 CRT-D and 22 ICD patients with induced episodes, the number with successful conversions was determined. The % of patients that had successful conversion was then reported.|||percentage of successful conversions|||Number
2702293|NCT01227785|Primary|Product Experiences Reported by the Site for All Patients for Study Duration|Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.|Overall study results|All patients from overall study population were considered. Of the total population, the number of product experiences was reported.|||experiences|||Number
2702294|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Impedance|RA pacing impedance results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month|||Ohms||Standard Deviation|Mean
2702295|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Impedance|RA pacing impedance results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge|||Ohms||Standard Deviation|Mean
2702296|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Impedance|RA pacing impedance results were reported at implant|implant|56 CRT-D and 11 ICD patients had data available at implant|||Ohms||Standard Deviation|Mean
2702297|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Impedance|RV pacing impedance results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit|||Ohms||Standard Deviation|Mean
2702298|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Impedance|RV pacing impedance results were reported for pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge|||Ohms||Standard Deviation|Mean
2702317|NCT01227785|Primary|Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude|RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients|implant|55 CRT-D patients and 11 ICD patients had available data at implant.|||milli volt (mV)||Standard Deviation|Mean
2702318|NCT01227785|Primary|Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients|LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.|1-month|68 patients in the CRT-D cohort had available data at 1month visit|||milli volt (mV)||Standard Deviation|Mean
2702319|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.|pre-discharge|69 patients in the CRT-D arm had available data at pre-discharge visit.|||milli volt (mV)||Standard Deviation|Mean
2702320|NCT01227785|Secondary|Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.|A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).|Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months|HF events were reported and adjudicated to classify patients into group 1 or 2. Group 1=17 HFEs in 13 patients. For patients with multiple HFEs,only the first with sufficient data was used. 8/13 with a HFE had data for the endpoint analysis.Group 2=95 patients with 9 month follow-up. 90/95 had data eligible for inclusion in the endpoint analysis.|||breaths/min||Inter-Quartile Range|Median
2702321|NCT01227785|Primary|Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.|implant|The number of CRT-D patients with available data at implant|||milli volt (mV)||Standard Deviation|Mean
2702322|NCT01227707|Secondary|TTP - Time to Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||months||Standard Deviation|Mean
2702323|NCT01227707|Secondary|Time to Disease Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||percentage of participants|||Number
2702324|NCT01227707|Secondary|OS - Time to Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||months||Standard Deviation|Mean
2702325|NCT01227707|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||percentage of participants|||Number
2702326|NCT01227707|Secondary|DFS - Time to Event|The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population|||months||Standard Deviation|Mean
2702327|NCT01227707|Secondary|Disease-Free Survival (DFS) - Percentage of Participants With an Event|DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population|||percentage of participants|||Number
2702328|NCT01227707|Secondary|Percentage of Participants With Relapse During Follow-Up|The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population; only participants who underwent radical surgery were included in the analysis|||percentage of participants|||Number
2702329|NCT01227707|Secondary|Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment|The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.|BL and within 6 weeks after the completion of study treatment|ITT population|||percentage of participants|||Number
2702330|NCT01227707|Secondary|Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment|Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population|||percentage of participants|||Number
2702331|NCT01227707|Secondary|Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment|Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population|||percentage of participants|||Number
2702332|NCT01227707|Secondary|Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure||6 to 8 weeks after completion of study treatment|ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)|||percentage of participants|||Number
2702333|NCT01227707|Secondary|Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)|The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.|Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)|ITT population|||percentage of participants|||Number
2702334|NCT01227707|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|6 to 8 weeks following completion of neoadjuvant treatment|ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2702335|NCT01227681|Primary|Motor Performance of Unified Parkinson's Disease Rating Scale|To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome.|2 years||||scores on a scale||Full Range|Mean
2702336|NCT01227668|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Weekly from Weeks 1 through 16 (end of treatment) of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2|||Participants|||Number
2702337|NCT01227668|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Weekly from Week 1 to Week 26 and continuously to end of treatment|All participants who took at least 1 dose of single-blind aripiprazole in Phase 1|||Participants|||Number
2702338|NCT01227668|Secondary|Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])|CG-I rating scale permits global evaluation of patient's improvement over time. At baseline (BL), CGI Severity of Illness assessment is performed, in which the clinician rates severity of patient's condition on a 7-point scale ranging from 1=no symptoms to 7=very severe symptoms. Higher total score=worse symptoms. At subsequent visits, clinician assesses patient's improvement relative to symptoms at baseline on CGI-I 7-point scale ranging from 1=very much improved to 7=very much worse. Since the drug targets irritability symptoms, the CGI focuses on severity of irritability secondary to autistic disorder. Lower score=more improved symptoms. LOCF data set includes data recorded at a given visit or, if nothing recorded, data areccarried forward from the prior visit. For secondary endpoints (endpt), hierarchical testing was used to keep overall experiment-wise type I error rate to <=0.05. diff=difference; IS=irritability scale; PA=primary analysis; signif=significance/significantly.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.|||Units on a scale||Standard Error|Mean
2702350|NCT01227629|Secondary|Trough Plasma Concentration of Dabigatran (BIBR 953)|The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.|12 weeks|All treated patients|||ng/ml||Standard Deviation|Mean
2702351|NCT01227629|Secondary|Activated Partial Thromboplastin Time (aPTT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability|||seconds||Standard Deviation|Mean
2702352|NCT01227629|Secondary|Ecarin Clotting Time (ECT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability|||seconds||Standard Deviation|Mean
2702353|NCT01227629|Secondary|11-dehydrothromboxane B2 (TXB2): Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability|||pg/mg Creatinine||Standard Deviation|Mean
2702354|NCT01227629|Secondary|Soluble Fibrin: Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All randomised patients, only per-protocol data included.|||µg/ml||Standard Deviation|Mean
2702339|NCT01227668|Secondary|Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])|ABC is an informant-based checklist used to assess and classify problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0=not at all a problem to 3=the problem is severe in degree), and resolve into 5 subscales: 1) irritability, agitation; 2) lethargy, social withdrawal; 3) stereotypic behavior; 4) hyperactivity, noncompliance; and 5) inappropriate speech. The ABC can be completed by parents, special educators, psychologists, direct caregivers, nurses, and others knowing the participant. Psychometric assessment of the ABC indicates that its subscales have high internal consistency, adequate reliability, and established validity. The ABC-I Subscale Score ranges from 0 to 45, with a negative change in score signifying improvement. LOCF data set includes data recorded at a given visit or, if no observation was recorded at that visit, data carried forward from the prior visit. chg=change; BL=baseline; APR=aripiprazole; vs=versus.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.|||Units on a scale||Standard Error|Mean
2702340|NCT01227668|Primary|Percentage of Patients Relapsing by Week 16|"Time of relapse=date when patient meets relapse criteria. There are 4 definitions for relapse: 1. Patient meets the following criteria for 2 consecutive visits: (a) Aberrant Behavior Checklist Irritability score ≥25% than score at end of Phase 1 AND (b) Clinical Global Impression Improvement scale rating of 'Much Worse' or 'Very Much Worse' relative to rating at end of Phase 1. If relapse criteria met at 1 visit, 2nd visit should occur in about 1 week to reevaluate whether relapse criteria are still met. 2. Patient discontinues for Lost to Follow-up after a visit in which he or she met Definition 1 criteria (a&b). 3. Patient begins a prohibited drug (whether a study investigator or outside source prescribed) to treat worsening symptoms of irritability of autistic disorder after a visit where patient met Definition 1 criteria (a&b). 4. Patient discontinues due to hospitalization for worsening symptoms of irritability or due to lack of efficacy based on investigator's assessment."|From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment|All participants who were randomized in Phase 2|||Percentage of participants|||Number
2702341|NCT01227655|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3~Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4~The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.~The NMSS total score is calculated by adding all domain scores (0-360), and lower scores mean less disability."|14-15 weeks||||units on a scale||Standard Deviation|Mean
2702342|NCT01227655|Secondary|Parkinson's Disease Sleep Scale (PDSS)|"The Parkinson's disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.~Subscale has 0-10 ratings, where 0 = severe and 10 = normal~The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14-15 weeks||||units on a scale||Standard Deviation|Mean
2702343|NCT01227655|Secondary|UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)|"Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint~UPDRS I evaluation of mentation, behavior, and mood~UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food~UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.~Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe~The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14-15 weeks||||units on a scale||Standard Deviation|Mean
2702344|NCT01227655|Primary|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.|14-15 weeks||||minutes||Standard Deviation|Mean
2702345|NCT01227629|Secondary|Severity of Adverse Events|Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.|12 weeks|Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)|||participants|||Number
2702346|NCT01227629|Secondary|Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline|Number of Participants with Increase of ALT to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
2702347|NCT01227629|Secondary|Number of Participants With Increase of Bilirubin to >2*Baseline|Increase of Bilirubin to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
2702348|NCT01227629|Secondary|Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline|Increase of AP to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
2702349|NCT01227629|Secondary|Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline|Increase of AST to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
2702356|NCT01227629|Secondary|Thromboembolic Events: Number of Participants Who Died|Occurence of death by all causes|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702357|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Other Major Cardiac Events|Occurence of other major adverse cardiac events|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702358|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Myocardial Infarction|Occurence of a myocardial infarction|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702359|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Systemic Thromboembolism|Occurence of a systemic thromboembolism|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702360|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Transient Ischemic Attack|Occurence of a transient ischemic attack|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702361|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Ischemic Stroke|Occurence of an ischemic stroke (fatal or non-fatal)|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702362|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Composite Endpoint|Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702363|NCT01227629|Primary|Number of Participants With Minor/Nuisance Bleeding Events|All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group|||Participants|||Number
2702364|NCT01227629|Primary|Number of Participants With Minor/Relevant Bleeding Events|Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group|||Participants|||Number
2702365|NCT01227629|Primary|Number of Participants With Fatal or Life-threatening Major Bleeding Events|Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more|12 weeks|All treated patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
2702366|NCT01227616|Secondary|Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP|Number of participants in each Treatment Period (TP)|Up to 6 treatment periods (5 weeks per treatment period)|ITT population|||participants|||Number
2702367|NCT01227616|Secondary|Changes in Transferrin Saturation (TSAT)|Mean change in TSAT from TP Baseline to Week 5 for each TP|Up to 6 treatment periods (5 weeks per treatment period)|Mean Change in TSAT at Week 5 – ITT Population|||Percent||Standard Deviation|Mean
2702368|NCT01227616|Primary|Hemoglobin Changes|Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.|Up to 6 treatment periods (5 weeks per treatment period)|Mean Change in Hemoglobin at Week 5 – ITT Population|||g/dL||Standard Deviation|Mean
2702369|NCT01227577|Secondary|Event-free Survival, Progression-free Survival and Overall Survival|Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2702370|NCT01227577|Secondary|Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Of the 128 participants analyzed, 3 participants received an escalated dose of 400 mg b.i.d.|||Participants|||Number
2702371|NCT01227577|Secondary|Number of Participants With Loss of CCyR, MMR and CMR|Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.|4 years|Numbers are based on the total number of participants who achieved and experienced loss of CMR (34 participants), CCyr (93 participants) and MMR (94 participants), respectively.|||Participants|||Number
2702372|NCT01227577|Secondary|Time to Progression of AP/BC|Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.|4 years|Of the 128 participants analyzed, 1 participant experienced progression to AP/BC.|||Months||95% Confidence Interval|Median
2702373|NCT01227577|Secondary|Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)|Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
2702374|NCT01227577|Secondary|Duration of CMR, CCyR and MMR|Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).|||Months||Standard Deviation|Mean
2702375|NCT01227577|Secondary|Time to CMR, CCyR and MMR|Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).|||Months||95% Confidence Interval|Median
2702376|NCT01227577|Secondary|Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)|"CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).~Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses."|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
2702377|NCT01227577|Primary|Number of Participants With Confirmed Complete Molecular Response (CMR)|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
2702378|NCT01227564|Other Pre-specified|Alzheimer's Disease Medication Administration Concerns Questionnaire (AD MACQ)|The AD MACQ was administered to the study partner to address preferences for medication administration by assessing: Question a: I would find it easy to give the study medication to the patient myself. Question b: The number of times the medication was given was convenient. Question c: I would prefer to have the study medication given at home by me instead of at the doctor's office by the doctor or nurse. Question d: I would prefer to have the study medication given at home by a nurse instead of at the doctor's office by the doctor or nurse. Question e: Overall, I am satisfied with the way the medication was given.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||percentage of participants|||Number
2702379|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R - Relative - Total Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 - 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702380|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R - Relative - Planning/Organization Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 - 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702381|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R - Relative - Prospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 - 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702382|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R - Relative - Retrospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 - 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702383|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R - Relative - Attention/Concentration Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13, and 17, with a range from 0 - 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702384|NCT01227564|Other Pre-specified|Change From Baseline in PDQ - Subject - Total Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 - 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702385|NCT01227564|Other Pre-specified|Change From Baseline in PDQ - Subject - Planning/Organization Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 - 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702386|NCT01227564|Other Pre-specified|Change From Baseline in PDQ - Subject - Prospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 - 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702387|NCT01227564|Other Pre-specified|Change From Baseline in PDQ - Subject - Retrospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 - 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702388|NCT01227564|Other Pre-specified|Change From Baseline in Perceived Deficits Questionnaire (PDQ) - Subject - Attention/Concentration Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13 and 17, with a range from 0 - 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702389|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgM ELISA Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The LLOQ determined for this assay was 50 U/mL. For any anti-Aβ IgM antibody level that was below the LLOQ (50 U/mL), the LLOD defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||U/ml||95% Confidence Interval|Geometric Mean
2702390|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The lower limit of quantification (LLOQ) determined for this assay was 100 U/mL. For any anti-Aβ IgG antibody level that was below the LLOQ (100 U/mL), the lower limit of detection (LLOD) defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||U/ml||95% Confidence Interval|Geometric Mean
2702391|NCT01227564|Other Pre-specified|Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time|CDR is a global clinical staging instrument that was administrated by a trained rater to assess a participant's level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. CDR global score was derived from the six domains according to a complex algorithm with emphasis on the Memory Domain score. Global CDR score = 0.5 with memory box score of 0.5. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3, with higher score indicating no significant function. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||percentage of participants|||Number
2702392|NCT01227564|Other Pre-specified|Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer's related-dementia was performed informally by the participant's friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the other caregivers providing support on ADL, IADL and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL and supervising; and: time per day during the past month on each of ADL, IADL, and supervising. The total Other Caregiver Time per month could range from 0 - 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||hours||95% Confidence Interval|Least Squares Mean
2702393|NCT01227564|Other Pre-specified|Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer's related-dementia was performed informally by the participant's friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the primary caregiver providing support on activities of daily living (ADL), instrumental activities of daily living (IADL) and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL, and supervising; and: time per day during the past month on each of ADL, IADL and supervising. The total Primary Caregiver Time per month could range from 0 - 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||hours||95% Confidence Interval|Least Squares Mean
2702394|NCT01227564|Other Pre-specified|Change From Baseline in Dependence Scale (DS) Score|An abbreviated administration (first 6 items) of the DS was used in this study. The DS is a brief study partner-completed measure which assesses the degree of support required by a subject with AD. Since the goal of treatment was to delay or arrest the processes leading to increased dependence, the DS represented a meaningful endpoint for clinical studies in AD. The dependence score was derived by summing the first 6 items of the DS. Item 1 and 2 ranged from 0 - 2 and item 3 - 6 ranged from 0 - 1. The total score was calculated by summing the score from each of the 6 items. So the total score could range from 0 - 8, with higher scores indicating greater dependence.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
2702395|NCT01227564|Other Pre-specified|Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score|The ADAS-Cog is a global cognitive measure. For the following 13 items, the participants were rated: Word Recall, Commands, Construction Praxis, Delayed Word Recall Task, Naming Task, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Instructions, Spoken Language Ability, Word-Finding Difficulty in Spontaneous Speech, Comprehension, and Number Cancellation. The ADAS-cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The total score was the sum of the scores from the 13 individual items. This study used a modified 85 point scale with a scoring range of 0 to 85 (13 items). Higher scores of the 13 individual items indicated greater cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
2702396|NCT01227564|Other Pre-specified|Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing. A positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
2702397|NCT01227564|Other Pre-specified|Change From Baseline in NPI Distress Score (NPI-D)|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. For each domain, the study partner also rated his/her own 'emotional or psychological' distress caused by the participant's behavior on a 6-point scale. The study partner NPI-D total score was calculated by summing the scores of the 12 sub-scale distress scores. A negative change indicated an improvement from baseline. The caregiver distress (NPI-D) total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
2702398|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. If a preliminary question for each domain was answered as 'Yes', each domain was rated on a 4-point frequency scale and on a 3-point severity scale. If the preliminary question was answered as 'No', the frequency, severity, and distress scales were set to zero. A negative change indicated an improvement from baseline. For each of the 12 domains, a sub-scale score is calculated as frequency*severity and ranges from 0 to 12. The NPI total score is then calculated by summing the scores of the 12 sub-scale scores. The NPI total scores ranges from 0 to 144 with higher scores indicating greater behavioral impairment. The caregiver distress score is not included in the NPI total score.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
2702399|NCT01227564|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)|Clinical Dementia Rating (CDR) is a global clinical staging instrument that was administrated by a trained rater to assess a participant's level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. A CDR-SOB score was derived based on individual scores from the six domains. A negative change indicated an improvement from baseline. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3. The CDR-SOB total score ranges from 0 to 18, with higher scores indicating greater dementia. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
2702400|NCT01227564|Other Pre-specified|Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from shopping, doing the laundry, simple financial transactions, comprehension of current events, some recreational or avocational activities, and reading. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
2702401|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychological Test Battery (NTB)|The NTB evaluated cognitive domains that are known to be affected early in the course of Alzheimer's disease (AD). The cognitive tests included in the NTB were: Rey Auditory Verbal Learning Test - Immediate recall, Detection, Identification, Go-No-Go Task, One Back Task, Controlled Oral Word Association Test, Category Fluency Test, and Rey Auditory Verbal Learning Test - delayed recall and recognition. For each of the eight NTB components, an individual z-score was derived based on the primary raw score of each test. Based on the individual z-scores, a composite z-score was derived using the formula: (z1-z2-z3-z4+z5+z6+z7+z8)/8. Positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||z-scores||95% Confidence Interval|Least Squares Mean
2702402|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right|Right HBSI measures the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
2702403|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left|Left HBSI measures the left hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
2702404|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total|Left HBSI and Right HBSI respectively measure the left hippocampal atrophy and the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans. HBSI (Total) is defined as the summation of the left HBSI and the right HBSI.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
2702405|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)|VBSI measures ventricular volume change from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
2702406|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)|BBSI measures whole brain atrophy from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans from the initial scan (baseline).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
2702407|NCT01227564|Other Pre-specified|Change From Baseline in Plasma Aβ x-40|Site personnel collecting the samples for plasma Aβ (x-40) concentrations and the results were blinded to the participant treatment group assignment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||pg/mL||95% Confidence Interval|Least Squares Mean
2702408|NCT01227564|Other Pre-specified|Change From Baseline in CSF Total Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
2702409|NCT01227564|Other Pre-specified|Change From Baseline in CSF p-Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
2702410|NCT01227564|Other Pre-specified|Change From Baseline in CSF Aβ x-42|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
2702411|NCT01227564|Other Pre-specified|Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at the Early termination (ET) visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
2703746|NCT01216397|Secondary|Participants Who Discontinued the Trial Because of an Adverse Event|Number of participants who discontinued the trial because of an adverse event|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
2702412|NCT01227564|Primary|Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)|Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.|104 weeks|The full analysis set (FAS) population included all randomized participants who had at least one dose of investigational product.|||ratio||95% Confidence Interval|Least Squares Mean
2702413|NCT01227551|Secondary|Durable Response Rate|Per Immune-Related Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI or calipers: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Durable Response Rate (DRR) = CR + PR.|6 months or more|ITT Population|||percentage of participants|||Number
2702414|NCT01227551|Primary|Percentage of Participants With Immune-related Progression-Free Survival (irPFS) at 6 Months|To assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months.|6 months|ITT Population|||percentage of participants||95% Confidence Interval|Number
2702415|NCT01227512|Secondary|Percentage of Participants Requiring Rescue Therapy for Hyponatremia|Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia.|7 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the placebo group.|||Percentage of participants|||Number
2702416|NCT01227512|Secondary|Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.|Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7.|48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 2 participants in the tolvaptan group and 3 participants in the placebo group.|||Percentage of participants|||Number
2702417|NCT01227512|Secondary|Time to First 2-point Improvement in CGI-S Score.|CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours.|Up to 72 hours|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 1 participant in the tolvaptan group and 3 participants in the placebo group.|||Hours||95% Confidence Interval|Median
2702418|NCT01227512|Secondary|Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).|"Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed.~A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose.~Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours."|0 to 72 hours|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for 3 participants in the tolvaptan group and 1 participant in the placebo group."|||mEq/L||Full Range|Least Squares Mean
2702419|NCT01227512|Secondary|Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.|"Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed.~The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse"|Baseline to 48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were not available for 2 participants in the tolvaptan group.|||Units on a scale||Full Range|Median
2702420|NCT01227512|Secondary|Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.|"Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed.~The CGI-S is a one-question rating scale which was as follows: Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time? 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 24 and 72 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group."|||Units on a scale||Full Range|Median
2702421|NCT01227512|Secondary|Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.|"Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed.~The CGI-S is a one-question rating scale which was as follows: Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time? 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 48 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group."|||Units on a scale||Full Range|Median
2702422|NCT01227512|Primary|Length of Hospital Stay (LoS)|LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.|45 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.|||Days||95% Confidence Interval|Median
2702423|NCT01227434|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants with protocol related toxicity described by CTCAE version 4.0|1-2 years||||participants|||Number
2702424|NCT01227434|Primary|Progression Free Survival|Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.|up to 142 weeks||||weeks||Full Range|Mean
2702425|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B|||Participants|||Number
2702426|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A H3N2|||Participants|||Number
2702427|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1|Proportion of patients seroprotected or seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1|||Participants|||Number
2702428|NCT01227421|Secondary|Influenza Antibody Response: Influenza B|Change in antibody titer for Influenza B|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B|||Fold change in antibody titer||Inter-Quartile Range|Median
2702429|NCT01227421|Secondary|Influenza Antibody Response: Influenza A H3N2|Change in antibody titer for Influenza A H3N2|28 days|Members of the intensive virologic follow up group with laboratory confirmed influenza A H3N2|||Fold change in antibody titer||Inter-Quartile Range|Median
2702430|NCT01227421|Secondary|Influenza Antibody Response Titer Change: Influenza A 2009 H1N1|change in influenza antibody titer for Influenza A 2009 H1N1|28 days|Member of the intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1|||Fold change in antibody titer||Inter-Quartile Range|Median
2702431|NCT01227421|Secondary|Complications of Influenza|Proportion of patients with a complication of influenza during the course of the study|28 days|All patients who received at least one dose of study medication|||Participants|||Number
2702432|NCT01227421|Secondary|Time Loss From Work|Time loss from work|28 days|Analysis conducted on 241 patients with laboratory confirmed influenza excluding those who are unemployed|||days||95% Confidence Interval|Mean
2702433|NCT01227421|Secondary|Symptom Severity Score Hours|Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms.|28 days|Analysis conducted for 257 patients with laboratory confirmed influenza|||symptom score *hour||Standard Deviation|Mean
2702434|NCT01227421|Secondary|Time to Return to Normal Daily Activities|Time in hours as reported by patient|28 days|Analysis conducted on 257 patients with laboratory confirmed influenza|||Hours||Inter-Quartile Range|Median
2702435|NCT01227421|Secondary|Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50)|Median time in hours|28 days|Analysis performed on 107 patients from the intensive virologic follow up population with laboratory confirmed influenza|||Hours||Inter-Quartile Range|Median
2702436|NCT01227421|Secondary|Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline|Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies|7 days|Analysis conducted on 113 patients from the intensive virologic follow up group with laboratory confirmed influenza|||LOG10 RNA copies||Standard Deviation|Mean
2702437|NCT01227421|Secondary|Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline|Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50)|7 days|Analysis conducted on 113 patients from intensive virologic follow up group with laboratory confirmed influenza|||LOG10 Titer||Standard Deviation|Mean
2702438|NCT01227421|Secondary|Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects|Time in hours (Median and Interquartile range)|at least 28 days|624 patients were enrolled based on inclusion/exclusion criteria. Secondary efficacy analyses were conducted on the 257 patients with laboratory confirmed influenza.|||Hours||Inter-Quartile Range|Median
2702439|NCT01227421|Primary|Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects|The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection|Up to 28 days|624 patients were enrolled based on inclusion/exclusion criteria. The primary efficacy analysis was conducted on the 257 patients with laboratory confirmed influenza.|||Hours||Inter-Quartile Range|Median
2702440|NCT01227395|Secondary|Number of Participants Prevented by Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2702488|NCT01227018|Other Pre-specified|Biomarker Evaluation|Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.|Pre-treatment and 1 week post-treatment|The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.||||||
2702441|NCT01227395|Secondary|Number of Participants That Responded to Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2702442|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702443|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702444|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702445|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702446|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702447|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702448|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.|||participants|||Number
2702449|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702450|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702451|NCT01227395|Primary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|9 years(MAX)|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.|||Events|||Number
2702452|NCT01227395|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.|9 years(MAX)|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
2702453|NCT01227382|Secondary|Adverse Events|Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.|24 hours|Percentage of participants with accurate diagnoses of cancer|||participants|||Number
2702454|NCT01227382|Secondary|Sampling Times for Each Device|The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).|15 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
2702455|NCT01227382|Secondary|Cholangioscopy Visualization Time|The portion of the total ERCP time spent on Cholangioscopy visualization.|30 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
2702456|NCT01227382|Secondary|Total Cholangioscopy Time|This is the total time it takes for the dye to be performed during the ERCP.|60 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
2702457|NCT01227382|Secondary|Total Procedure Time|The total time to perform ERCP|120 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
2702458|NCT01227382|Secondary|Procedure Technical Success|The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.|day 1|Percentage of participants with accurate diagnoses of cancer|||participants|||Number
2702459|NCT01227382|Primary|Percentage of Participants With Accurate Diagnoses of Cancer|The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.|up to 7 days after the procedure|Percentage of participants with accurate diagnoses of cancer|||percentage of accurate diagnoses|||Number
2702460|NCT01227278|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Deviation|Mean
2702461|NCT01227278|Secondary|Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of participants|||Number
2702462|NCT01227278|Secondary|Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Deviation|Mean
2702463|NCT01227278|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score|SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of participants|||Number
2702464|NCT01227278|Secondary|Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Deviation|Mean
2702465|NCT01227278|Secondary|Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||hospitalizations/person-year||95% Confidence Interval|Number
2702512|NCT01226719|Secondary|To Determine the Acute Toxicity Produced by This Regimen.|The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.|18 months|All patients on study|||participants|||Number
2702466|NCT01227278|Secondary|Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||percentage of participants|||Number
2702467|NCT01227278|Secondary|Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||participants|||Number
2702468|NCT01227278|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to 561|The safety population included all participants who received at least one dose of investigational drug.|||participants|||Number
2702469|NCT01227278|Primary|Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.|Day 1 up to 393|The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||AECOPD events/person-year||95% Confidence Interval|Number
2702470|NCT01227265|Primary|Change From Baseline in Total Epworth Sleepiness Scale (ESS) at Week 12|The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness. The mean change from baseline in total EES was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Score on a Scale||Standard Error|Mean
2702471|NCT01227265|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Percentage of participants|||Number
2702472|NCT01227265|Primary|Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase|The number of participants with Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Participants|||Number
2702473|NCT01227265|Primary|Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase|The number of participants with Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Participants|||Number
2702474|NCT01227265|Secondary|"Change From Baseline in Average On Time (Hours Per Day) Without Troublesome Dyskinesia at Week 12"|"On time is when a PD participant's symptoms are improved. Mean on time without troublesome dyskinesias is derived from the available diary data collected for 3 days immediately prior to a clinic visit. On time without troublesome dyskinesia is the sum of on time without dyskinesia plus on time with non-troublesome dyskinesia as recorded in the diary. The mean change from baseline in on time was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.|||hours per day||Standard Error|Mean
2702546|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up|Frequency of daily urination|Baseline to 3 month||||number of voids||Standard Deviation|Mean
2702547|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up|Frequency of daily urination|Baseline to 6 weeks||||number of voids||Standard Deviation|Mean
2702475|NCT01227265|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"A participant with at least a 30% reduction in mean off time from Baseline to End of Treatment (Week 12) is considered as responder. The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week 12 visit."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least one dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.|||Percentage of participants|||Number
2702476|NCT01227265|Primary|"Change From Baseline in Average Off Time (Hours Per Day) at Week 12"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week 12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis (cLDA) with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.|||hours per day||Standard Error|Mean
2702477|NCT01227252|Secondary|Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration|The Least Squares means were adjusted for baseline concentration.|Predose (Day 14), 24 Hours post-dose (Day 15)|All participants who received study drug on Day 14 and had evaluable pharmacodynamic data were included in the analysis.|||percent change (%)||95% Confidence Interval|Least Squares Mean
2702478|NCT01227252|Secondary|Cerebrospinal Fluid (CSF) Concentration of LY2886721||24 Hours post-dose (Day 15)|A subset of all participants who received study drug on Day 14 and had evaluable pharmacodynamic data was included in the analysis.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2702479|NCT01227252|Secondary|Plasma Amyloid Beta (Aβ) 1-40 Concentration|The minimum concentration (Cnadir) is being reported for this outcome measure.|Predose (Day 14) up to Day 19|All participants who received study drug on Day 14 and had evaluable pharmacodynamic data were included in the analysis.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2702480|NCT01227252|Secondary|Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721|Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure.|Predose (Day 14) to 24 Hours post-dose (Day 15)|All participants who received study drug on Day 14 and had evaluable pharmacokinetic data were included in the analysis.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2702481|NCT01227252|Secondary|Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721||Predose (Day 14) up to Day 19|All participants who received study drug on Day 14 and had evaluable pharmacokinetic data were included in the analysis.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2702482|NCT01227252|Primary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.|Predose up to Day 70|All randomized participants were included in the analysis.|||Participants|||Count of Participants
2702483|NCT01227057|Secondary|Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months|The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.|6 months||||units on a scale||Standard Deviation|Mean
2702484|NCT01227057|Secondary|The Activities of Daily Living in Hoarding (ADL-H)|The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment. Higher scores represent increased impairment. Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.|6 months||||units on a scale||Standard Deviation|Mean
2702485|NCT01227057|Primary|Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months|Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.|6 months||||units on a scale||Standard Deviation|Mean
2702486|NCT01227044|Secondary|Heavy Drinking Days|This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.|One year|data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.|||days||Standard Deviation|Mean
2702487|NCT01227044|Primary|HAART Adherence|The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.|One year|data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.|||Participants|||Count of Participants
2702489|NCT01227018|Secondary|Number of Patients With Each Worst Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy.|||participants|||Number
2702490|NCT01227018|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|study entry to date of death or last date known alive (assessed over 2.5 yrs)|All patients are included in the analysis on intention‐totreat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2702491|NCT01227018|Secondary|Best Response|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date, to date of disease progression (assessed up to 1 year)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non‐evaluable for best overall response.|||participants|||Number
2702492|NCT01227018|Primary|Disease Control Rate|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.|at 8 weeks from the start of therapy|Patients who received treatment and who were available for determination of response.|||percentage of participants|||Number
2702493|NCT01227005|Secondary|30-day Mortality|Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy|first 30 days after ED admission||||participants|||Number
2702494|NCT01227005|Secondary|24-hour Mortality|Mortality rate at 24 hours after arrival|First 24 hours after ED admission||||participants|||Number
2702495|NCT01227005|Primary|Units of Blood Products Required During the First 24 Hours After Emergency Department Admission|Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)|first 24 hours after ED admission||||units of blood||Inter-Quartile Range|Median
2702496|NCT01226914|Primary|To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).|First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs|90 days||||mL||Inter-Quartile Range|Median
2702497|NCT01226745|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 35 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
2702498|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination|A whole body examination, paying particular attention to identify precancerous or cancerous lesions was done by a dermatologist and based on the clinical judgment of the dermatologist the abnormalities were categorized as clinically significant or clinically not significant. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline up to end of the treatment, assessed up to Week 255|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
2702499|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination|Subjects underwent comprehensive ophthalmic examination (COE) including best corrected visual acuity (Snellen), manifest refractions, pupil examination, ocular motility, nystagmus, confrontation visual fields, Ishihara color plates, Amsler grid, and tonometry as well as a biomicroscopy slit lamp examination of the conjunctiva, cornea, anterior chamber, iris and lens; and a fundoscopic examination (with dilation) of the vitreous, optic nerve, retinal vessels, macula, and peripheral retina. Optical Coherence Tomography (OCT): Thicknesses of the macular retina and retinal nerve fiber layer at the optic nerve head in each eye was assessed by OCT using the fast macular thickness map scan and the fast retinal nerve fiber layer (RNFL) scan features, respectively. The abnormalities of the ophthalmologic examination was judged to be clinically significant or not as per the investigators discretion. The ophthalmologic examination was performed for both right eye (RE) and left eye (LE).|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.|||Subjects|||Number
2702500|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures|The 12-lead ECG was recorded after the subject was in supine position for 5 minutes. ECGs were acquired on digital cardiographs. Abnormal findings were analyzed as clinically significant or not clinically significant as per the discretion of the study investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
2702501|NCT01226745|Primary|Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)|"DLCO was one of the most clinically valuable tests of lung function. The DLCO measure the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject was early terminated from the study during the additional 2 year period with delay. The values for the DLCO % of predicted was defined as the mean value of 2 test results that were within a 10% variability of each other."|Baseline, Week 40, 52, early termination, Week 152, 200, 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.|||Percentage of predicted value||Standard Deviation|Mean
2702502|NCT01226745|Primary|Change From Baseline in Forced Vital Capacity (FVC)|FVC (% of predicted value) was the volume of air which was forcibly exhaled from the lungs after taking the deepest breath possible. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure|||Percentage of predicted value||Standard Deviation|Mean
2702503|NCT01226745|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)|FEV1 was defined as the maximal volume of air exhaled in the 1st second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.|||Percentage of predicted value||Standard Deviation|Mean
2702504|NCT01226745|Secondary|Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment|Brain volume was obtained by magnetic resonance imaging (MRI). Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. Brain volume changes very little over time. Hence, the PBVC at the end of treatment was calculated by adding up all the PBVC values from the scans performed during the extension treatment period.|Baseline and at end of treatment (Week 255)|FAS included all subjects who provided any post baseline efficacy data. One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.|||Percent brain volume||Standard Deviation|Mean
2702505|NCT01226745|Secondary|Change From Baseline in Lesion Volume at the End of the Treatment (EoT)|Brain lesion volume was obtained by magnetic resonance imaging (MRI). Extension study baseline was defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EOT) was defined as the last visit during the treatment period. Change from extension baseline to EOT = last treatment period value in extension study — extension baseline value.|Baseline, End of treatment (5 years)|FAS included all subjects who provided any post baseline efficacy data.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.|||Cubic centimeter (cc)||Standard Deviation|Mean
2702506|NCT01226745|Secondary|Number of Gadolinium (Gd)-Enhanced Lesions|Gd-enhanced lesions were obtained by magnetic resonance imaging (MRI) at each scheduled assessment visit over the study period. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EoT) lesion count is the average number of lesion counts per scan, calculated by dividing the sum of all lesion counts by number of scans during the extension treatment period. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study.Full Analysis Set (FAS) included all subjects who provided any post baseline efficacy data.|Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)|"FAS. n” signifies the number of subjects analyzed for individual time point in the outcome measure.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period."|||Lesions||Standard Deviation|Mean
2702507|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Vital Signs|Vital signs included oral temperature, pulse, respiration rate and blood pressure (BP) (taken after 5 minutes in the sitting position). The abnormalities in vital signs were decided as clinically significant or not based on the clinical judgment of the investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
2702508|NCT01226732|Secondary|Preliminary Efficacy Assessment: Response Rate (RR)|Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Includes all patients evaluable for response (4 patients were not evaluable)|||participants|||Number
2702509|NCT01226732|Secondary|Safety|To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen.|18 months||||participants|||Number
2702510|NCT01226732|Primary|Dose Determination|To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.|18 months||||mg/m^2|||Number
2702511|NCT01226719|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|All patients on study|||months||95% Confidence Interval|Median
2702513|NCT01226719|Secondary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study|||months||95% Confidence Interval|Median
2702514|NCT01226719|Secondary|R0 Resection Rate|To determine the rate of complete (R0) resection for patients treated with this regimen.|18 months|Includes patients who were surgical candidates and underwent surgery on study|||percentage of patients with surgery|||Number
2702515|NCT01226719|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients deemed to be evaluable for response who were evaluated for response|||percentage of evaluable participants|||Number
2702516|NCT01226706|Secondary|Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months|Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up|Baseline to 6 months||||Participants|||Count of Participants
2702517|NCT01226706|Secondary|Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up|Frequency of participants needing self-catheterization from baseline to 6 month follow-up.|Baseline to 6 months||||Participants|||Number
2702518|NCT01226706|Secondary|Frequency of Urinary Tract Infections From Baseline to 6 Months|Frequency of urinary tract infections from baseline to 6 month-follow-up|Baseline to 6 months||||number of occurences|||Number
2702519|NCT01226706|Secondary|24 Hour Pad Weight (gm) at 9 Months|weight of pad (in gm) worn for 24 hours to detect urine loss|9 months||||gm||Standard Deviation|Mean
2702520|NCT01226706|Secondary|24 Hour Pad Weight (gm) at 3 Months|weight of pad (in gm) worn for 24 hours to detect urine loss|3 months||||gm||Standard Deviation|Mean
2702521|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 6 Months|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.~Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 6 months||||summary score||Standard Deviation|Mean
2702522|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 3 Months|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.~Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 3 months||||summary score||Standard Deviation|Mean
2702523|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.~Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 6 weeks||||summary score||Standard Deviation|Mean
2702524|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 6 Months|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.~Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 no problems at all, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 many severe problems. A higher score indicates a more negative impression of current bladder problems."|Baseline to 6 months||||summary score||Standard Deviation|Mean
2702525|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 3 Months|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.~Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 no problems at all, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 many severe problems. A higher score indicates a more negative impression of current bladder problems."|Baseline to 3 months||||summary score||Standard Deviation|Mean
2702526|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.~Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 no problems at all, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 many severe problems. A higher score indicates a more negative impression of current bladder problems."|Baseline to 6 weeks||||summary score||Standard Deviation|Mean
2702527|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.~The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 months||||summary score||Standard Deviation|Mean
2702528|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.~The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 3 months||||summary score||Standard Deviation|Mean
2702529|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Urogenital Distress Inventory - 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 weeks||||summary score||Standard Deviation|Mean
2702530|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 months||||summary score||Standard Deviation|Mean
2702531|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 3 months||||summary score||Standard Deviation|Mean
2702532|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for not at all, 1 for slightly, 2 for moderately, and 3 for greatly. The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 weeks||||scores on a scale||Standard Deviation|Mean
2702533|NCT01226706|Secondary|Subjective Benefit Assessment at 6 Months|"Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:~dry (complete response),~improvement (> 50% reduction in incontinence),~partial response (≤ 50% reduction in incontinence),~no response to treatment."|Baseline to 6 months||||score on a 4-point rating scale||Standard Deviation|Mean
2702534|NCT01226706|Secondary|Subjective Benefit Assessment at 3 Months|"Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:~dry (complete response),~improvement (> 50% reduction in incontinence),~partial response (≤ 50% reduction in incontinence),~no response to treatment."|Baseline to 3 months||||score on a 4-point rating scale||Standard Deviation|Mean
2702535|NCT01226706|Secondary|Subjective Benefit Assessment at 6 Weeks|"Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:~dry (complete response),~improvement (> 50% reduction in incontinence),~partial response (≤ 50% reduction in incontinence),~no response to treatment."|Baseline to 6 weeks||||score on a 4-point rating scale||Standard Deviation|Mean
2702536|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 24 Months Follow-up|Frequency of night voiding|Baseline and 24 months||||number of voids||Standard Deviation|Mean
2702537|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 12 Month Follow-up|Frequency of night voiding|Baseline to 12 months||||number of voids||Standard Deviation|Mean
2702538|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 9 Month Follow-up|Frequency of night voiding|Baseline and 9 months||||Number of voids||Standard Deviation|Mean
2702539|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 6 Month Follow-up|Frequency of night voiding|Baseline to 6 months||||number of voids||Standard Deviation|Mean
2702540|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 3 Month Follow-up|Frequency of night voiding|Baseline to 3 months||||Number of voids||Standard Deviation|Mean
2702541|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 6 Week Follow-up|Frequency of night voiding|Baseline to 6 weeks||||number of voids||Standard Deviation|Mean
2702542|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up|Frequency of daily urination|Baseline to 24 months||||number of voids||Standard Deviation|Mean
2702543|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up|Frequency of daily urination|Baseline to 12 months||||number of voids||Standard Deviation|Mean
2702544|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up|Frequency of daily urination|Baseline to 9 months||||number of voids||Standard Deviation|Mean
2702545|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up|Frequency of daily urination|Baseline to 6 months||||number of voids||Standard Deviation|Mean
2702554|NCT01226706|Primary|Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up|"Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra.~Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate."|Baseline to 6 months||||mL||Standard Deviation|Mean
2702555|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal behavior score at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal behavior score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
2702556|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal ideation score <5 at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal ideation score during the extension treatment period. Nine (9) participants from 1 site with major quality issues were excluded.|||percentage of participants|||Number
2702557|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGAS score during the acute treatment period and at least 1 CGAS score during the extension treatment period [last observation carried forward (LOCF)], excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702558|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGI-S score during the acute treatment period and at least 1 CGI-S score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702559|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity total score during the acute treatment period and at least 1 PARS severity total score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702560|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity score for GAD during the acute treatment period and at least 1 PARS severity score for GAD during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702561|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal behavior score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
2702562|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal ideation score during the acute treatment period, whose baseline maximum C-SSRS suicidal ideation score was <5. Nine (9) participants from 1 site with major quality issues were excluded.|||percentage of participants|||Number
2702563|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline [last observation carried forward (LOCF)] CGAS score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702564|NCT01226511|Secondary|Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale|Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.|10 weeks|Randomized participants with at least 1 post-baseline CGI-S score [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
2702565|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline CGI-S score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702566|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity total score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702567|NCT01226511|Secondary|Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD|Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
2702568|NCT01226511|Primary|Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
2702569|NCT01226485|Secondary|Part C and D: Progression Free Survival (PFS)|For each participant in Part C and D who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, PFS was censored at the date of last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to Progressive Disease or Death from Any Cause (Up To 32 Months)|Part C and Part D participants who received at least one dose of study drug and had evaluable PFS data. Participants censored were Part C=8 and Part D=22. Per protocol, Part A data were not collected for PFS.|||months||95% Confidence Interval|Median
2702570|NCT01226485|Secondary|Number of Participants With Clinical Benefit Rate (Stable Disease [SD] + Partial Response [PR] + Complete Response [CR])|Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions.|Baseline to Disease Progression or Death Due to Any Cause (Up To 32 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2702571|NCT01226485|Secondary|PK: Time of Maximal Concentration (Tmax) of LSN3185556|PK: Time of Maximal Concentration (Tmax)|Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h|All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.|||hour (h)||Full Range|Median
2702572|NCT01226485|Secondary|PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556|PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556|Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h|All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2702573|NCT01226485|Secondary|PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of LSN3185556|PK: Area Under the Plasma Concentration-time Curve from time Zero to 24 Hours (AUC[0-24]) of LSN3185556|Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h|All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.|||microgram*hour/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2702574|NCT01226485|Secondary|PK: Time of Maximal Concentration (Tmax)|PK: Time of Maximal Concentration (Tmax)|Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h|All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.|||hour (h)||Full Range|Median
2702575|NCT01226485|Secondary|PK: Maximum Observed Drug Concentration (Cmax)|PK: Maximum Observed Drug Concentration (Cmax)|Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h|All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2702576|NCT01226485|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])|Pharmacokinetics (PK): 1.Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])|Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h|All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.|||nanogram*hour/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2702577|NCT01226485|Primary|Recommended Phase 2 Dose: Maximum Tolerated Dose|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had <33% probability of causing a DLT in Cycle 1 of Part A.|Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)|Part A participants who received at least one dose of study drug.|||milligrams (mg)|||Number
2702578|NCT01226459|Primary|Subject Assessment of Scalp Coverage|Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.|Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.|||scores on a scale||Standard Deviation|Mean
2702579|NCT01226459|Secondary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 12|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.|||hairs per centimeter squared||Standard Error|Mean
2702580|NCT01226459|Primary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.|||hairs per centimeter squared||Standard Deviation|Mean
2702581|NCT01226420|Secondary|Safety of Alefacept Infusions in Patients With Chronic GVHD.|Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.|2 years|All enrolled subjects were included in the Analysis of Safety Events|||Total adverse events|||Number
2702582|NCT01226420|Primary|Efficacy|Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.|2 years|All enrolled subjects|||participants|||Number
2702583|NCT01226121|Secondary|Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)||90 days||||percentage of patients|||Number
2702584|NCT01226121|Primary|Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)||30 days after injection||||percentage of participants|||Number
2703747|NCT01216397|Secondary|Participants With Treatment Emergent Adverse Events|Number of patients with treatment emergent AEs|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
2702585|NCT01226095|Secondary|Number of Participants Who Experienced Adverse Events and Serious Adverse Events|Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 4 weeks|The tolerability population included all enrolled participants.|||participants|||Number
2702586|NCT01226095|Secondary|Number of Participants With the Ability to Carry Out Normal Activities at Each Visit|The number of participants who were able or unable to carry out normal activities was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||participants|||Number
2702587|NCT01226095|Secondary|Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)|The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.|2 and 4 weeks|Data were analyzed for all participants for which data were available.|||participants|||Number
2702588|NCT01226095|Primary|Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).|Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.|4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||Participants|||Number
2702589|NCT01226095|Secondary|Duration of Morning Stiffness|The duration of morning stiffness in minutes was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, however, only participants with available morning stiffness data were included in the analysis for each visit.|||minutes||Standard Deviation|Mean
2702590|NCT01226095|Secondary|Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).|Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.|2 and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||Participants|||Number
2702591|NCT01226095|Secondary|Number of Participants With Joint Tenderness/Stiffness at Each Visit|Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||participants|||Number
2702592|NCT01226095|Secondary|Percent of Participant Compliance|The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).|2 and 4 weeks|Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.|||percentage of participant compliance|||Number
2702593|NCT01226095|Primary|Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.|Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.|Baseline and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||units on a scale||Standard Deviation|Mean
2702594|NCT01226043|Other Pre-specified|Number of Patients With Hypoglycemic Events|The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) <70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG <36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG >70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).|each study phase (crossover, re-randomization, observational) up to 40 weeks|The safety population for each phase (crossover, re-randomization, observational) was the total treated population defined as all the patients who were randomized and exposed to at least one dose of Lantus during that phase.|||participants having reported the event|||Number
2702595|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Observational Phase||From week 10 to week 40 (observational phase)|Re-randomized population at week 4 and included in the observational phase at week 10 and exposed to at least one dose of the IP|||percentage of patients|||Number
2702596|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase||From week 4 to week 10 (re-randomization phase)|Re-randomized population at week 4 exposed to at least one dose of the IP|||percentage of patients|||Number
2702597|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase||From baseline to week 4 (crossover phase)|Randomized population (crossover phase) exposed to at least one dose of the IP|||percentage of patients|||Number
2702598|NCT01226043|Secondary|Time to First Observation of HbA1c <7%||From week 10 to week 40 (observational phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of HbA1c.|||Days since Re-randomization (week 4)||95% Confidence Interval|Median
2702599|NCT01226043|Secondary|Percentage of Patients Achieving HbA1c Goal|Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)|measured at week 40 or at study discontinuation|Patients from the mITT population for Re-randomization and Observational Phases who had at least one post re-randomization assessment of HbA1c.|||percentage of patients|||Number
2702600|NCT01226043|Secondary|Change in Lantus Dose Injected Per Day||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG.|||U (insulin unit)||Standard Error|Least Squares Mean
2702601|NCT01226043|Secondary|Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL||At week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had a re-randomization baseline assessment FPG > or = 110 (week 4) and at least one post re-randomization assessment of FPG.|||percentage of patients|||Number
2702602|NCT01226043|Secondary|Change in Fasting Plasma Glucose (FPG)||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG measured during the on-treatment period.|||mg/dL||Standard Error|Least Squares Mean
2702603|NCT01226043|Secondary|Healthcare Professional's (HCP) Recommendation|"The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: Overall, how strongly would you recommend each of the insulin delivery systems for your patients?~5 points scale: from 1= Not Recommended to 5= Recommended"|At week 4 (end of crossover phase)|"The HCP Questionnaire analysis population consisted of HCPs:~who treated at least 1 randomized patient during the crossover phase and this(these) patient(s) received at least one dose of Lantus via both insulin delivery systems during the crossover phase~who completed the HCP Questionnaire."|||units on a scale||Full Range|Median
2702604|NCT01226043|Secondary|Patient Preference Composite Score|"The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire:~Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar?~Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin?~Question 14c: How strongly would you prefer each insulin delivery system for long-term use?~Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15."|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered to the 3 questions 14a, 14b and 14c.|||units on a scale||95% Confidence Interval|Least Squares Mean
2702605|NCT01226043|Primary|Patient Overall Preference|"The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d Overall, what is your level of preference for each of the insulin delivery systems?~5 points scale: from 1=Not preferred to 5= Always preferred"|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered question 14d.|||units on a scale||95% Confidence Interval|Least Squares Mean
2702606|NCT01225991|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|Resilience: the Connor-Davidson Resilience scale (CD-RISC) quantifies stress coping ability. The CD-RISC is a 25-item self-administered scale, although where necessary, a staff professional could read out each question to the subject and record the answer. The subject is directed to respond to each question with reference to the previous month, understanding that if a particular situation has not arisen in this time, then the response should be determined by how the person thinks they would have reacted. Scoring of the full 25 item scale is based on summing the total of each item, which is scored from 0-4. The full range is therefore from 0 to 100, with higher scores reflecting greater resilience. The outcome measure is a change score from Week 1 to Week 12.|Change Scores from Week 1 to Week 12||||units on a scale||Standard Deviation|Mean
2702607|NCT01225991|Secondary|Profile of Mood States (POMS)|Depressive symptoms: Repeated assessment of depressive symptoms severity will be made using the Profile of Mood States (POMS). The scale consisted of 65 adjectives rated on 5-point scale 0= not at all; 1=a little; 2=moderately; 3=quite a bit; 4=extremely. Five subscales were included in analysis: tension-anxiety (9 items, score range: 0-36), depression (15 items, range 0-60), friendliness (12 items, range 0-48), vigor-activity (8 items, range 0-32), and fatigue (7 items, range 0-28). Higher vigor-activity and friendliness scores reflect a good mood or emotion (high scores indicating better outcomes), and low scores in the other subscales (tension, depression, and fatigue) reflect a good mood or emotion (low scores indicating better outcomes).|Week 1 and 12||||units on a scale||Standard Deviation|Mean
2702608|NCT01225991|Secondary|(UKU) Side Effects Rating Scale Profile|The UKU assessment will rate the number of participants with emerging adverse events.|Weeks 1-4, 6, 8, 10, 12||||Participants|||Count of Participants
2702609|NCT01225991|Secondary|Visual Analogue Scale to Evaluate Fatigue (VAS-F)|The Visual Analogue Scale to Evaluate Fatigue (VAS-F) is an assessment of fatigue severity. The Visual Analogue Scale (VAS) measures a characteristic or attitude that ranges across a continuum of values from none (0) to an extreme amount of fatigue and energy (10). Scores fall between 0 and 10 anchored by word descriptors at each end and the patient marks on the line the point that they feel represents their perception of their current state. The scale consists of 18 items relating to the subjective experience of fatigue. Two subscales are summed separately and reported as follows: Items 1-5 and 11-18 represent fatigue from none (0) to extreme fatigue (10) and items 6-10 represent energy from none (0) to extreme energy (10). The outcome measures the change scores of energy and fatigue from Week 1 to Week 12. The VAS subscales for Fatigue Scale range: 0-130 and Energy Scale range: 0-50 with higher scores indicating greater energy and fatigue.|Change scores from Week 1 to Week 12 of energy and fatigue||||units on a scale||Standard Deviation|Mean
2702610|NCT01225991|Primary|Pain Rating Index|The Pain Rating Index ranked values associated with adjectives depicting the severity of pain from the McGill Pain Questionnaire (MPQ). The assessment is comprised of 15 adjectives, each of which is scored on a scale ranging from 0 (none) to 3 (severe) and summed to arrive at a score ranging from 0 (no pain) to 45 (worst possible pain), to measure the extent of pain/tenderness and swelling. The Pain Rating Index final scores were averaged to indicate an overall report of joint pain and stiffness.|Change score at baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2702611|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702612|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702613|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702614|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702615|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702616|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702617|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702618|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702619|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702620|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702649|NCT01225835|Secondary|Endometrial Thickness on Day of hCG Administration|Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration.|approximately day 10|Per protocol set of participants. One participant in the Follitrophin Alpha arm was missing a measurement.|||mm||Standard Deviation|Mean
2702621|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702622|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702623|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702624|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702625|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702626|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702627|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702628|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702629|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702630|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702631|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702650|NCT01225835|Secondary|Number of Frozen Oocytes at Pronuclear Stage|No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen.|approximately day 14|Per protocol set of participants who had embryos transferred|||oocytes||Standard Deviation|Mean
2702632|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702633|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702634|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
2702635|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702636|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2702637|NCT01225926|Primary|Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3|Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.|Month 3|Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.|||logMAR||Standard Deviation|Mean
2702638|NCT01225887|Secondary|Progression Free Survival|the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.|The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years|The time in months that a patient survived progression-free.|||months||90% Confidence Interval|Median
2702639|NCT01225887|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2702640|NCT01225887|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|for disease that can be evaluated by physical exam, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2702641|NCT01225887|Primary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1|For disease that can be evaluated by physical exam,response was assessed prior to each cycle CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2702642|NCT01225887|Primary|Number of Participants With Adverse Events|The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0|Up to 5 years|Patients on study who experienced adverse events (Grade 3 or higher)|||Participants|||Count of Participants
2702643|NCT01225835|Secondary|Summary of Pregnancy Outcome|Pregnancy outcomes were reported at the optional long-term follow up visit.|up to 10 months|Per protocol set of participants who reported information during the optional long-term follow up visit.|||participants|||Number
2702644|NCT01225835|Secondary|Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test|A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy.|approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test|Per protocol set|||percentage of participants|||Number
2702645|NCT01225835|Secondary|Number of Ampoules of Gonadotrophins Used|Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha.|Day 1 up to Day 12|Per protocol set|||ampoules||Standard Deviation|Mean
2702646|NCT01225835|Secondary|Number of Days Stimulated With Gonadotrophins|Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study.|Day 1 up to Day 12|Per protocol set|||days||Standard Deviation|Mean
2702647|NCT01225835|Secondary|Percentage of Participants With Successful Embryo Transfer||approximately day 18|Per protocol set|||percentage of participants|||Number
2702651|NCT01225835|Secondary|Best Quality of an Embryo Transferred|"Embryo quality was measured by the following grades:~Grade 1: Evenly sized cells, regular cleavage, no fragmentation~Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation~Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation~Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell~Grade 4: Extensive fragmentation, only 1 cell intact~Grade 5: Totally fragmented, no viable cells.~Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable."|approximately day 14|Per protocol set of participants who had embryos transferred|||participants|||Number
2702652|NCT01225835|Secondary|Number of Embryos Transferred|Mean number of embryos transferred 2-3 days following oocyte retrieval.|approximately day 14|The per-protocol (PP) set who had embryos transferred. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||embryos||Standard Deviation|Mean
2702653|NCT01225835|Secondary|Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade|"The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality.~Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once."|approximately day 13|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||participants|||Number
2702654|NCT01225835|Secondary|Number of Pronuclear Oocytes|Pronuclear oocytes are fertilized oocytes.|approximately day 13 after study start|The per-protocol (PP) set of participants with non-missing values.|||oocytes||Standard Deviation|Mean
2702655|NCT01225835|Secondary|Number of Cumulus-oocyte Complexes Retrieved|Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.|approximately day 12 after study start|The per-protocol (PP) set of participants with non-missing values.|||oocytes||Standard Deviation|Mean
2702656|NCT01225835|Secondary|Average Follicle Diameter at hCG Administration||approximately day 10|The per-protocol (PP) set of participants with non-missing values.|||mm||Standard Deviation|Mean
2702657|NCT01225835|Secondary|Number of Follicles at hCG Administration|Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration.|approximately day 10|The per-protocol (PP) set of participants with non-missing values. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||follicles||Standard Deviation|Mean
2702658|NCT01225835|Secondary|Percentage of Participants With Ongoing Pregnancy|Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test.|approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||percentage of participants|||Number
2702659|NCT01225835|Secondary|Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration|The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect.|Day 7, approximately Day 10 (hCG Administration)|Full analysis set|||Youden's index|||Number
2702660|NCT01225835|Primary|Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration|Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years).|approximately day 10|Full analysis set|||ng/ml||Standard Deviation|Mean
2702661|NCT01225822|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval|Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.|up to day 8+/-2 days visit||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2702662|NCT01225822|Secondary|Plasma Concentration (Cmax) of Dabigatran|"Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state.~Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state.~Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state"|Day 1 to end of treatment||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2702663|NCT01225822|Secondary|Laboratory Analyses|"Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Haematocrit [%]: (0.35-0.45) for women and (0.39−0.51) for men Haemoglobin [g/dL]: (11.6−15.4) for women and (13.2−17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9−10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72−1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men"|Screening to end of treatment|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||participants|||Number
2702690|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 6 ([post dose] 7 hours post allergen challenge)||||Percentage||Standard Deviation|Mean
2704549|NCT01211600|Secondary|Number of Participants That Received Anticoagulation Within 24 Hours|Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)|Within 24 hours postpartum.||||Participants|||Count of Participants
2702664|NCT01225822|Secondary|Number of Participants With Clinically Significant, Minor or Any Bleeding Events|"Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as~Spontaneous skin haematoma larger than >25 cm²~Wound haematoma >100 cm²~Spontaneous nose bleed >5 minutes~Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention~Spontaneous rectal bleeding (more than spot on toilet paper)~Gingival bleeding >5 minutes~Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events."|Treatment period (up to day 8+/-2 days visit)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||participants|||Number
2702665|NCT01225822|Secondary|Rate of Transfusions Due to Bleedings|Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||Percentage of patients|||Number
2702666|NCT01225822|Secondary|Volume of Blood Loss|Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||ml||Standard Deviation|Mean
2702667|NCT01225822|Primary|Number of Participants With Major Bleeding Events (MBE)||From approximately 14 days prior to surgery to 4-6 weeks post surgery|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||participants|||Number
2702668|NCT01225822|Secondary|Number of Participants With Proximal DVT|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
2702669|NCT01225822|Secondary|Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality|Treatment period (up to day 10)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
2702670|NCT01225822|Secondary|Number of Participants With VTE Events and All Cause Mortality|Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
2702671|NCT01225822|Primary|Number of Participants With Venous Thromboembolic (VTE) Events|Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
2702672|NCT01225731|Primary|Number of Particpants Discontinuing Study Treatment Due to Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.|Up to 52 weeks|All particpants receiving at least one dose of study drug during the treatment period.|||Participants|||Number
2702673|NCT01225731|Primary|Number of Participants Experiencing Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 72 weeks|All participants receiving at least one dose of study drug.|||Participants|||Number
2702674|NCT01225731|Secondary|Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.|||Percentage of participants|||Number
2702675|NCT01225731|Secondary|Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint, excluding all participants on the placebo arm.|||Percentage of participants|||Number
2702691|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 5 (post dose)|PD Analysis set|||Percentage||Standard Deviation|Mean
2704550|NCT01211600|Secondary|Length of Hospital Stay|Length of hospital stay (days)|Immediate postpartum.||||Days||Inter-Quartile Range|Median
2702676|NCT01225731|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.|||Score on a scale||95% Confidence Interval|Mean
2702677|NCT01225731|Secondary|Percentage of Participants With PASI 50 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
2702678|NCT01225731|Secondary|Mean Change From Baseline in PASI Score at Weeks 12 and 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).|Baseline and Weeks 12 and 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for Week 12 and Week 16.|||Score on a scale||95% Confidence Interval|Mean
2702679|NCT01225731|Secondary|PASI 75 Response Rate by Time|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score at Week 2, 4, 6, 8, 12, or 16.|Up to 16 Weeks|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. and data for the specific Week.|||Percentage of participants|||Number
2702680|NCT01225731|Secondary|Percentage of Participants With PASI 100 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data fior this endpoint|||Percentage of participants|||Number
2702681|NCT01225731|Secondary|Percentage of Participants With PASI 90 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint.|||Percentage of participants|||Number
2702692|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 7 ([post-dose] 24 hours post allergen challenge)||||mg/mL||Full Range|Geometric Mean
2702693|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 5 ([post-dose] pre allergen challenge)||||mg/mL||Full Range|Geometric Mean
2702682|NCT01225731|Secondary|"Percentage of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 16"|The PGA is used to determine the overall severity of a subject's psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PGA value was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
2702683|NCT01225731|Secondary|Percentage of Participants With a PASI 75 Response at Week 12|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 12|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
2702684|NCT01225731|Primary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
2702685|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients|A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug|First dosing up to 48 months|The safety analysis set defined as all patients who took at least one dose of study drug|||Percentage of Patients|||Number
2702686|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization|Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment|||Percentage of Patients|||Number
2702687|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization|Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment|||Percentage of Patients|||Number
2702688|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization|Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment|||Percentage of Patients|||Number
2702689|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 7 ([post dose] 24 hours post allergen challenge)||||Percentage||Standard Deviation|Mean
2702694|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 1 (pre-dose)|PD Analysis set|||mg/mL||Full Range|Geometric Mean
2702695|NCT01225549|Secondary|Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge|AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set|||Percentage||Full Range|Geometric Mean
2702696|NCT01225549|Secondary|Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge|Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set|||Percentage||Full Range|Geometric Mean
2702697|NCT01225549|Primary|Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1|LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1|From Randomization to end of treatment|PD Analysis set|||Percentage||Full Range|Geometric Mean
2702698|NCT01225354|Secondary|Aesthetic Improvement|Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo|Visit 2-4|||||||
2702699|NCT01225354|Secondary|Assessment of Malar Deficiency|Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale.|Visit 1-4|||||||
2702700|NCT01225354|Secondary|Subject First Impression|Each subject will complete the 10-point (1-Not at all to 10-Very Much) evaluating their own first impression at Baseline, Visit 2 (if applicable), Visit 3, and Visit 4.|baseline, Visit 2, Visit3, and Visit 4||2013-12-31|12/2013||||
2702701|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|2 weeks post optimal cosmetic result||||Participants with improved self-esteem|||Number
2702702|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|1 month post-optimal cosmetic result|All subjects completing indicated visit|||Participants with improved self-esteem|||Number
2702703|NCT01225354|Primary|Blinded Evaluations of First Impression|Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of each of the 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria.|After the 1-month post optimal correction visit for subject 20|||||||
2702704|NCT01225289|Secondary|Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)|difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation|first day and after 6 month||||absorbance units||Standard Error|Mean
2702705|NCT01225289|Secondary|Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation||first day and after 6 month||||ratio||Standard Error|Mean
2702706|NCT01225289|Secondary|Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation||first day and after 6 month||||pg/ml||Standard Error|Mean
2702707|NCT01225289|Primary|Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation||first day and after 6 month||||mg/L||Standard Error|Mean
2702708|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24||Weeks 13 to 24||||days||Inter-Quartile Range|Median
2702709|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12||Weeks 1 to 12||||days||Inter-Quartile Range|Median
2702710|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Weight at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||kg||Standard Error|Least Squares Mean
2702711|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||kg/m^2||Standard Error|Least Squares Mean
2702712|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56|CFQ-R respiratory domain is defined in Outcome Measure 17.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||units on a scale||Standard Error|Least Squares Mean
2702713|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||units on a scale||95% Confidence Interval|Least Squares Mean
2702714|NCT01225211|Secondary|Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||percent change||Standard Error|Least Squares Mean
2702738|NCT01225159|Secondary|Morbidities and All Causes Mortality|morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)|within the first 30 days after surgery||||participants|||Number
2702715|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.|||percent change||95% Confidence Interval|Least Squares Mean
2702716|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2702717|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||percent change||95% Confidence Interval|Least Squares Mean
2702718|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2702719|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2702720|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||liters||95% Confidence Interval|Least Squares Mean
2702721|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||Standard Error|Least Squares Mean
2702722|NCT01225211|Secondary|Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 2: Baseline, Day 14|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||95% Confidence Interval|Least Squares Mean
2702723|NCT01225211|Secondary|Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 1: Baseline, Day 14|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||95% Confidence Interval|Least Squares Mean
2702724|NCT01225211|Primary|Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Hankinson method.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2702725|NCT01225211|Primary|Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56||Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||95% Confidence Interval|Least Squares Mean
2702726|NCT01225211|Primary|Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21||Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2702727|NCT01225211|Primary|Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs|AEs and SAEs are defined in Outcome Measure 1.|Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 4 Safety Set included all participants who received at least 1 dose of study drug in Cohort 4.|||participants|||Number
2702728|NCT01225211|Primary|Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)|Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).|Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 2 and 3 Safety Set included all participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||participants|||Number
2702739|NCT01225159|Primary|Nosocomial Infection|Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.|within the first 30 day after surgery||||participants|||Number
2702740|NCT01225146|Secondary|Goldman Visual Field Changes|Goldman Visual Field changes at 6 and 12 months from baseline|12 months|Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)||||||
2702729|NCT01225211|Primary|Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).|Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)|Cohort 1 Safety Set included all participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||participants|||Number
2702730|NCT01225172|Secondary|Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment|Absolute copy numbers and relative expression of insulin receptor isoforms (IR-A, IR-B) in pre- and posttreatment fresh tumor tissues were to be measured. This outcome was not measured due to early termination of the study.|24 weeks after initiation of study|Data for this Outcome Measure was not collected for any participants because the study was terminated||||||
2702731|NCT01225172|Secondary|Treatment Failure Rate (TFR)|The TFR was to be calculated as the total number of subjects who discontinued the treatment for any reason (including disease progression, treatment toxicity, and death) at 24 weeks divided by the total number of subjects randomized/assigned to the arm and treated. In the monotherapy arm, the TFR was to be assessed while subjects were on monotherapy.|24 weeks after initiation of study treatment|TFR data was not collected for any participants because the study was terminated||||||
2702732|NCT01225172|Secondary|Number of On-study Laboratory Abnormalities: Grade 3-4|Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin > 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria|Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)|All treated participants|||Number of abnormalities|||Number
2702733|NCT01225172|Secondary|Number of On-study Laboratory Abnormalities: Grade 1-2|Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin > 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein. Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria|Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)|All treated participants|||Number of abnormalities|||Number
2702734|NCT01225172|Secondary|Duration of Response (DOR) in Participants With Measurable Disease|DOR was to be performed to further characterize the response rate at Week 24. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR could not be assessed due to early termination of the study.|24 weeks after initiation of study treatment|DOR data was not collected for any participants because the study was terminated early||||||
2702735|NCT01225172|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths|An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.|Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months|All treated participants|||Participants|||Count of Participants
2702736|NCT01225172|Secondary|The Objective Response Rate (ORR) in Participants With Measurable Disease|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were to be evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure was not met due to early termination of the study"|24 weeks after initiation of study treatment|ORR data was not collected for any participants because the study was terminated||||||
2702737|NCT01225172|Primary|Progression Free Survival Rate at 24 Weeks|Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study.|24 weeks after initiation of study treatment|PFS data was not collected for any participants because the study was terminated||||||
2702741|NCT01225146|Secondary|Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery|Changes, by disc areas, of capillary non-perfusion in the periphery (evaluated by wide-field fluorescein angiography) at 3, 6, 9 and 12 months from baseline.|12 months|Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)||||||
2702742|NCT01225146|Secondary|Mean Change in Central Foveal Volume|Mean change in Central Foveal Volume on High Resolution OCT|12 months|Patients in cohort 2 did not complete the study.|||mm^3||Full Range|Mean
2702743|NCT01225146|Secondary|Neovascularization Development|Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.|12 months|Patients in cohort 2 did not complete the study.|||Percentage of patients|||Number
2702744|NCT01225146|Secondary|Incidence and Severity of Adverse Events (Ocular and Non-ocular).|Incidence and severity of adverse events (ocular and non-ocular) from baseline through 12 months will be evaluated.|12 months||||incidents|||Number
2702745|NCT01225146|Primary|Mean Change in logMAR|Mean change from baseline in ETDRS NCVA.|12 months.|Patients in cohort 2 did not complete the study.|||logMAR||Full Range|Mean
2702746|NCT01225068|Primary|Effect Size of VAS Pain|"Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation.~This is the primary outcome measure."|6 weeks from baseline|per protocol|||units on a scale||Standard Deviation|Mean
2702747|NCT01225055|Secondary|Amino-terminal Propeptide of Type 1 Collagen|The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.|||ng/ml||Standard Deviation|Mean
2702748|NCT01225055|Secondary|Bone-specific Alkaline Phosphatase|The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy|Baseline to 12 Months|One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.|||ng/ml||Standard Deviation|Mean
2702749|NCT01225055|Secondary|C-terminal Telopeptide|The mean change in C-terminal telopeptide from baseline after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.|||ng/ml||Standard Deviation|Mean
2702750|NCT01225055|Secondary|Bone Mineral Density (BMD) by DXA at Femoral Neck|The mean change in BMD of the femoral neck after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. One additional subjects was not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 13 subjects that were not analyzed.|||g/cm^2||Standard Deviation|Mean
2702751|NCT01225055|Secondary|Bone Mineral Density (BMD) by DXA at the Lumbar Spine.|The mean change in BMD at the lumbar spine from baseline after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Five additional subjects were not analyzed due to metal artifacts that interfered with analysis. This accounts for the 17 subjects that were not analyzed.|||g/cm^2||Standard Deviation|Mean
2702752|NCT01225055|Primary|Bone Mineral Density BMD of the Total Hip as Assessed by DXA.|The mean change in BMD of the total hip after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Two additional subjects were not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 14 subjects that were not analyzed.|||g/cm^2||Standard Deviation|Mean
2702753|NCT01225029|Secondary|Time to First Enteral Feed||hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours||||hours||Inter-Quartile Range|Mean
2702754|NCT01225029|Secondary|Duration of ICU Admission||every day until discharge, an average of approximately 8 days and a maximum of 12 days||||calendar days||Inter-Quartile Range|Mean
2702755|NCT01225029|Primary|Duration of Respiratory Support||every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours||||hours||Inter-Quartile Range|Median
2702756|NCT01224925|Secondary|Postoperative Pain 1 Week After Treatment.|Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.|one week|Postoperative pain 1 week after treatment|||participants|||Number
2702757|NCT01224925|Primary|Survival of Capped Pulps|Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.|44 month|Three patients were lost from follow-up in Dycal group, two patients in WMTA group. Intention to treat principle (ITT) was applied; the analysis comprised all allocated cases|||Survival days|Tooth|95% Confidence Interval|Mean
2702758|NCT01224821|Secondary|Time to Disease Progression or Death for All Participants, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants with disease progression or those who died were analyzed.|||months||95% Confidence Interval|Median
2702790|NCT01224639|Primary|Number of Participants With Solicited Local and Systemic AEs||Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
2702759|NCT01224821|Secondary|Time to Disease Progression or Death for Responders, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed.|||months||95% Confidence Interval|Median
2702760|NCT01224821|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants who died during the study were analyzed.|||months||95% Confidence Interval|Median
2702761|NCT01224821|Secondary|Median Time to Treatment Failure for All Participants|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population|||months||95% Confidence Interval|Median
2702762|NCT01224821|Secondary|Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.|||months||95% Confidence Interval|Median
2702763|NCT01224821|Secondary|Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.|||months||95% Confidence Interval|Median
2702764|NCT01224821|Secondary|Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.|||months||95% Confidence Interval|Median
2702765|NCT01224821|Secondary|Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.|||months||95% Confidence Interval|Median
2702766|NCT01224821|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.|||months||95% Confidence Interval|Median
2702767|NCT01224821|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.|||months||95% Confidence Interval|Median
2702768|NCT01224821|Secondary|Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed.|||participants|||Number
2702769|NCT01224821|Secondary|Number of Participants With CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
2702770|NCT01224821|Secondary|Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2702771|NCT01224821|Secondary|Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
2702772|NCT01224821|Secondary|Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)|Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant's mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001-149999 cells/millimeter cubed (mm^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population|||participants|||Number
2702773|NCT01224821|Primary|Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites|The dosimetry methods were validated for seven different clinical research sites.|Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U|Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose.|||participants|||Number
2702774|NCT01224782|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.|Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .|||participants|||Number
2702775|NCT01224782|Secondary|Mean Weekly Dose of Zemplar (Paricalcitol)|Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).|From Baseline up to 12 months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.|||micrograms||Standard Deviation|Mean
2702776|NCT01224782|Secondary|Percentage of Participants With Hypercalcemia|The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.|From Baseline up to 12 months|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.|||percentage of participants|||Number
2702777|NCT01224782|Secondary|Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)|The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.|||percentage of participants|||Number
2702778|NCT01224782|Primary|Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2|The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.|||percentage of participants|||Number
2704551|NCT01211600|Secondary|Intraoperative Trial Details - Closure of Subcutaneous Tissue|Number of participants requiring subcutaneous tissue closure|Time of Cesarean||||Participants|||Count of Participants
2702779|NCT01224782|Primary|Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values|Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a > 30% decrease in iPTH compared with the initial values at baseline.|||months||Standard Deviation|Mean
2702780|NCT01224678|Primary|Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms|To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.|12 months|86 of the 300 patients were analyzed for the primary endpoint|||percent change||Standard Deviation|Mean
2702781|NCT01224639|Secondary|Titers of Vaccine Viremia||14 Days after each vaccination|Due to the low prevalence of vaccine viremia, estimates of average titer levels of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.||||||
2702782|NCT01224639|Secondary|Duration of Vaccine Viremia||14 Days after each vaccination|Due to the low prevalence of vaccine viremia, estimates of average titer duration of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.||||||
2702783|NCT01224639|Secondary|Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination|Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.|Baseline and at multiple time points up to Day 14 after each vaccination|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||participants|||Number
2702784|NCT01224639|Secondary|Percentage of Participants With Durability of Immune Response|Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer >=10 where pre-vaccination PRNT 50 titer <10, or post-vaccination PRNT(50) Titer >=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer >=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.|Days 180 and 270|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||percentage of participants||95% Confidence Interval|Number
2702785|NCT01224639|Secondary|Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination|Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).|Days 14 and 30 after second vaccination (Days 104 and 120 respectively)|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||percentage of participants||95% Confidence Interval|Number
2702786|NCT01224639|Secondary|Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination|Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.|Days 14, 30, 60 and 90 after first vaccination|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||percentage of participants||95% Confidence Interval|Number
2702787|NCT01224639|Secondary|GMTs of All Four Dengue Serotypes After Second Vaccination|GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.|Days 14 and 30 after second vaccination (Day 104 and 120 respectively)|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing MN Assay samples.|||titer||95% Confidence Interval|Geometric Mean
2702788|NCT01224639|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination|GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.|Days 14, 30, 60 and 90 after first vaccination|The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing microneutralization (MN) Assay samples.|||titer||95% Confidence Interval|Geometric Mean
2702789|NCT01224639|Primary|Number of Participants With Unsolicited Local and Systemic AEs||Baseline up to 30 days after second vaccination (Day 120)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
2702791|NCT01224639|Primary|Number of Participants With Systemic Adverse Events (AEs) by Severity|Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.|Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
2702792|NCT01224639|Primary|Number of Participants With Local Injection Site Reaction by Severity|Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than [>] 15 millimeter [mm]); Moderate as (15-30 mm); Severe (>30 mm), swelling was categorized as Mild (<15 mm); Moderate (15-30 mm); Severe (>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).|Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
2702793|NCT01224626|Primary|Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.|Baseline to 8 weeks|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.|||participants|||Number
2702794|NCT01224626|Secondary|Adverse Drug Reactions Unlisted in Japanese Package Insert.|The adverse drug reactions that have not been included in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702795|NCT01224626|Primary|Number of Participants With Adverse Drug Reactions.|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2702796|NCT01224444|Secondary|Incomplete Adenoma Resection of Small and Large Adenomas|Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).|1 year|||||||
2702797|NCT01224444|Primary|Percent of Incompletely Resected Adenomatous Polyps|Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.|1 year||||percentage of incomplete resection|Participants|95% Confidence Interval|Number
2702798|NCT01224431|Secondary|Length of Cry|cry video recorded and measured after needle stick until pt stopped crying|On average the first hour in the emergency department; from needle stick to end of lumbar puncture||||seconds||Standard Deviation|Mean
2702799|NCT01224431|Primary|Pain, Measured as Units on a Scale|Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible|on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.||||units on scale, 0-5||Standard Deviation|Mean
2702800|NCT01224236|Secondary|Transfusions|# of transfusions infants required after enrollment.|enrollment to 36 weeks postmenstrual age (PMA)||||transfusions||Inter-Quartile Range|Median
2702801|NCT01224236|Primary|Hematocrit (Hct)|For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.|36 weeks postmenstrual age (PMA)||||percentage of red blood cells in blood||Standard Deviation|Mean
2702802|NCT01224171|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).~Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?"|From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.|Overall Safety Population|||participants|||Number
2702843|NCT01223378|Primary|Change in Mean Diurnal IOP at Visit 6 (Day 28)|Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost|Baseline and Visit 6 (Day 28)|Intent-to-treat population, observed data (study eye)|||mm Hg||Standard Deviation|Mean
2702803|NCT01224171|Secondary|Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation|"Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percent deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|TNFα Antagonist Failure ITT Subpopulation|||percentage of participants||95% Confidence Interval|Number
2702804|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the Overall Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|Overall ITT population|||percentage of participants||95% Confidence Interval|Number
2702805|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|TNFα Antagonist Failure ITT Subpopulation|||percentage of participants||95% Confidence Interval|Number
2702806|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|Overall ITT population|||percentage of participants||95% Confidence Interval|Number
2702807|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation|||percentage of participants||95% Confidence Interval|Number
2702808|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 6 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
2702926|NCT01222533|Secondary|Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)|Total quantity of the analyte that is excreted in urine over the time interval 0 to 6 hours at steady state.|Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.|PK Set. All patients with analysable data.|||ng||Geometric Coefficient of Variation|Geometric Mean
2702809|NCT01224171|Primary|Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion.|||percentage of participants||95% Confidence Interval|Number
2702810|NCT01224158|Secondary|Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area|Hard-to-reach mean score is defined as mean of scores over following areas separately d; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across middle of tooth and I covers incisal area. Plaque on each area was assigned one of the following score: on a scale (0 indicates no dental plaque and 1 indicates plaque present in the measured segment of the tooth).|Day 28 and 42|FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.|||Units on a scale||Standard Deviation|Mean
2702811|NCT01224158|Secondary|Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42|Hard-to-reach mean score is defined as mean of scores over following areas combined; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across middle of tooth and I covers incisal area. Plaque was disclosed on a scale (0 indicates no dental plaque to 1 indicates dental plaque), Mean RPI overall was calculated for each participant as total score for all tooth sites assessed divided by total number of tooth sites assessed.|Day 28 and 42|FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.|||Units on a scale||Standard Deviation|Mean
2702812|NCT01224158|Secondary|Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28|Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the total score for all tooth sites assessed divided by the total number of tooth sites assessed.|Day 28|FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.|||Units on a scale||Standard Deviation|Mean
2702813|NCT01224158|Secondary|Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42|Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the total score for all tooth sites assessed divided by the total number of tooth sites assessed.|Day 42|FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.|||Units on a scale||Standard Deviation|Mean
2702814|NCT01224158|Secondary|Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28|Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale with score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.|Day 28|Full Analysis Set (FAS), included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.|||Unit on a scale||Standard Deviation|Mean
2702815|NCT01224158|Primary|Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42|Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.|Day 42|Full Analysis Set (FAS), included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.|||Unit on a scale||Standard Deviation|Mean
2702816|NCT01224015|Primary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines|The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.|||Percentage of participants|||Number
2702817|NCT01223963|Other Pre-specified|Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure|The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated.|up to 12 months post-procedure||||participants|||Number
2702818|NCT01223963|Primary|Number of Adverse Events|Number of Adverse events reported during the study period|01may2008 - 31dec2009||||number of AE|||Number
2702819|NCT01223937|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 3 months|Safety analysis set|||participants|||Number
2702820|NCT01223937|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug.|Day 1 up to 3 months|Safety analysis set|||participants|||Number
2702821|NCT01223937|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
2702822|NCT01223937|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
2702823|NCT01223937|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||minutes||Standard Deviation|Mean
2702824|NCT01223937|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||probability|||Number
2702825|NCT01223937|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||nocturnal voids||Standard Deviation|Mean
2702826|NCT01223937|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).|||probability|||Number
2702844|NCT01223365|Secondary|Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status|The COMM was a clinician-rated scale developed as a brief self-report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long-term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.|Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration Period. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52|Post titration Safety Analysis set|||units on a scale||Standard Deviation|Mean
2702827|NCT01223937|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).|||nocturnal voids||Standard Deviation|Mean
2702828|NCT01223703|Secondary|Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.|"NYHA class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs, etc...~NYHA class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~NYHA class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest NYHA class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|one year||||units on a scale||Standard Deviation|Mean
2702829|NCT01223703|Secondary|Functional Capacity (Change in Peak Oxygen Uptake, VO2)|Change in functional capacity expressed as a peak oxygen uptake (VO2), that was acquired breath-by-breath by pneumotachograph (with bidirectional differential pressure) during cardiopulmonary exercize testing.|one year||||ml/kg/min||Standard Deviation|Mean
2702830|NCT01223703|Secondary|LV Diastolic Function|Change in LV diastolic function assessed by echocardiography: mitral diastolic inflow velocities (peak velocity of early ventricular filling [E-wave], peak velocity of late ventricular filling [A-wave], E/A ratio, and E-wave deceleration time), diastolic function score (graded on a scale from 1 to 4) were used.|one year||||E/A ratio||Standard Deviation|Mean
2702831|NCT01223703|Primary|Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up|The primary end point of the study was the change in LV systolic function expressed as LVEF between baseline and 12-month follow-up. The following parameters were measured according to the professional standards defined by the American Society of Echocardiography and the European Association of Echocardiography|one year|A sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with p<0.05 (2-tailed) at the Student t test for unpaired data.|||ejection fraction (percentage)||Standard Deviation|Mean
2702832|NCT01223469|Primary|Number of Subjects With Operative and Post-operative Serious Adverse Events|"For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.~For AF patients 3 months (±2 weeks)following the index procedure."|3 months for AF arm; 7 days for the right SVT arm||||participants|||Number
2702833|NCT01223404|Secondary|Diastolic Blood Pressure|Diastolic blood pressure in mmHg.|Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application).|Healthy non-smokers (only study completers).|||mmHG||Standard Deviation|Mean
2702834|NCT01223404|Secondary|Systolic Blood Pressure|Systolic blood pressure (mmHg)|Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application)|Healthy non-smokers|||mmHG||Standard Deviation|Mean
2702835|NCT01223404|Secondary|Subjective State|"End-of-session subjective state is measured by the Profile of Mood States (POMS). We utilize Total Mood Disturbance (TMD) as a summary measure, derived by adding the total scores on the five negative mood scales (tension, depression, anger, fatigue, confusion) and subtracting the score on the one positive mood scale (vigor). The theoretical range of the TMD scale is -32 to 228, with negative values indicating less mood disturbance, i.e., a more positive emotional state."|1 day|Healthy non-smokers (only study completers).|||units on a scale||95% Confidence Interval|Mean
2702836|NCT01223404|Primary|Default Network Activity|Cognitive task-induced default network deactivation, measured by functional Magnetic Resonance Imaging. The default network was probed by five pre-defined ROIs per hemisphere. Task-induced deactivation was averaged across all ROIs.|1 day|Healthy non-smokers (only study completers).|||percentage of task-induced signal change||95% Confidence Interval|Mean
2702837|NCT01223404|Primary|Signal Detection Performance|Signal detection on cognitive tasks performed in the MR scanner. For the attention task, this represents the percentage of trials in which the participant responded when a signal was presented. In the working memory task (N-back task), this represents the percentage of all target sequences to which the participant responded.|1 day|Healthy adult non-smokers (only study completers).|||percentage of all targets||95% Confidence Interval|Mean
2702838|NCT01223404|Primary|Reaction Time|average reaction time on cognitive task performed in the MR scanner|1 day|18 healthy male and female adult non-smokers. Only study completers are included, due to the within-subject design.|||ms||95% Confidence Interval|Mean
2702839|NCT01223378|Secondary|Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)|The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (points 8 AM, 12 PM, and 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)|baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)|Intent-to-treat, observed data (study eye)|||mm Hg||Standard Deviation|Mean
2702840|NCT01223378|Secondary|Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)|The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)|baseline and Visit 6 (Day 28)|Intent to treat, data as observed (study eye)|||mm Hg||Standard Deviation|Mean
2702841|NCT01223378|Secondary|IOP </=18mm Hg|Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution|Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)|Intent-to-treat population, observed data (study eye)|||Participants|||Count of Participants
2702842|NCT01223378|Secondary|Change in Mean Diurnal IOP at Visits 4,5, and 7|Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost|Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)|Intent-to-treat population, observed data (study eye)|||mm Hg||Standard Deviation|Mean
2702845|NCT01223365|Secondary|Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status|The ABC was a clinician rated scale that consisted of a brief (21 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as 1 point, and points were added to calculate the total score. All but 1 of the 21 items (the provider's impression) was used in calculating the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). Participants with a total score of 3 or greater were classified as exhibiting inappropriate opioid use during the study.|Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52|Post-titration Safety Analysis set|||units on a scale||Standard Deviation|Mean
2702846|NCT01223365|Secondary|Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain - Revised (SOAPP-R)|"SOAPP-R is a clinician-rated scale used to assess each patient's risk of developing aberrant drug use behaviors while on long term opioid therapy. SOAPP-R consists of 24 questions that address 8 concepts: substance abuse history, medication related behaviors, antisocial behaviors/history, psychosocial problems, psychiatric history, physician patient relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues (Butler et al 2008). Each question is answered using a 5 point Likert-like scale, with 0=never, 1=seldom, 2=sometimes, 3=often, and 4=very often for a total range of 0-96. The higher the overall score, the greater the probability the patient is at risk for displaying aberrant behaviors consistent with drug use.~An overall score of 18 or higher is considered positive for predicting aberrant drug related behavior, therefore the reported risk categories are~<18 and~<=18. Results indicate timeframe followed by risk cat"|End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment Period|Safety analysis set|||Participants|||Count of Participants
2702847|NCT01223365|Secondary|Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status|The PGA of the method of pain control consisted of a asking patients a single question to assess their method of pain control during the previous 24 hours as either poor, fair, good, or excellent (Rothman et al 2009).|Baseline for new participants was Day 1, i.e. the first day of open-label titration. Baseline for rollover participants was the baseline in study 3079. Week 4 (end of titration, start of open-label treatment), Week 52, last visit up to Week 52|Full analysis set included all patients in the safety analysis set who had at least 1 postbaseline efficacy assessment. Participants contributing to each time point are listed in the time point label.|||Participants|||Count of Participants
2702848|NCT01223365|Primary|Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status|"Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient's hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to no response at 3 consecutive test frequencies."|Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods|Safety analysis set. The endpoint value is from the post-titration safety set (n=42, 92, 157, 291)|||Participants|||Count of Participants
2702849|NCT01223365|Primary|Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status|"A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event.~For overall results, the worst postbaseline finding for the participant was summarized.~Results below are formatted as Baseline ECG result - Overall ECG result."|Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period|Post-titration Safety analysis set. Only those participants with both baseline and visit electrocardiogram findings were summarized.|||Participants|||Count of Participants
2702850|NCT01223365|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 of open-label titration period - Week 52 of the open-label treatment period|Safety analysis set. One rollover participant did not have vital signs values.|||Participants|||Count of Participants
2702851|NCT01223365|Primary|Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status|"Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~alanine aminotransferase (ALT): >=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L~aspartate aminotransferase (AST): >=3 times ULN. Normal range is 9-36 U/L~blood urea nitrogen (BUN): >=10.71 mmol/L~creatinine: >=177 μmol/L~uric acid: M>=625, F>=506 μmol/L~white blood cell count: <=3.0*10^9/L~hemoglobin: M<=115, F<=95 g/dL~hematocrit: M<0.37, F<0.32 L/L~urine blood (hemoglobin): >=2 unit increase from baseline~urine glucose: >=2 unit increase from baseline"|Day 1 - Week 52 of the open-label treatment period|Posttitration Safety Analysis set. The posttitration safety analysis set included all patients who successfully completed the open label titration period and received 1 or more doses of study drug treatment in the open label treatment period.|||Participants|||Count of Participants
2702852|NCT01223365|Primary|Participants With Adverse Experiences|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of open-label titration period - Week 52 of the open-label treatment period|Safety analysis set|||Participants|||Count of Participants
2702853|NCT01223352|Other Pre-specified|Number of Patients With Treatment-emergent Hemoglobin Abnormalities|"Number of patients with marked hemoglobin decreases (absolute values below 10 g/dL). The worst post-baseline value was considered.~The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date."|Baseline, up to Week 24|All randomized patients who received at least one dose of study drug and with available data.|||Participants|||Number
2702854|NCT01223352|Other Pre-specified|Number of Patients With Treatment-emergent Liver Function Abnormalities|Number of patients with increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN). The worst post-baseline value was considered. The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date.|Baseline, up to Week 24|All randomized patients who received at least one dose of study drug and with available data.|||Participants|||Number
2702855|NCT01223352|Other Pre-specified|Change From Baseline in Global Clincial Impression Scale (GCIS) at End of Study|The GCIS is an assessment tool providing a single global assessment of the patient's current overall clinical condition: Very Good, Good, Neither Good or Bad, Bad and Very Bad. The assessment was performed both by the physician and the parents / legal representatives independently. Global clinical impression (GCI) at end of study was compared to GCI at baseline and the number of patients with clinical condition considered as worsened, improved or unchanged are determined.|Baseline, up to Week 24 on average|All-randomized set. Because all 64 randomized patients were treated with at least one dose of study drug, the All-randomized set was identical to the All-treated set.|||Participants|||Number
2702856|NCT01223352|Other Pre-specified|Change From Baseline in WHO Functional Class at End of Study|"The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension (PH):~Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class IIII (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms.~Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined."|Baseline, up to Week 24 on average|All-randomized set. Because all 64 randomized patients were treated with at least one dose of study drug, the All-randomized set was identical to the All-treated set.|||Participants|||Number
2702857|NCT01223352|Other Pre-specified|Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056)|Concentrations of the metabolites were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. Daily exposure to the metabolites corresponds to the area under the concentration-time curve [AUC(0-24)] of the corresponding metabolite over a period of 24 hours, and was calculated in the same manner as the primary endpoint. AUC(0-24c) was corrected to 2 mg/kg (target dose) [AUC(0-24c)].|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2702858|NCT01223352|Other Pre-specified|Time to Reach Cmax [Tmax] of Bosentan|"Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively.~tmax was obtained directly from the measured plasma concentrations."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||hours||Full Range|Median
2702859|NCT01223352|Other Pre-specified|Dose-corrected Maximum Plasma Concentration [Cmaxc] of Bosentan|"Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively.~The peak plasma concentration (Cmax) of bosentan was directly obtained from the measured plasma concentrations and was dose-corrected to the target dose of 2 mg/kg (Cmaxc)."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per-protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||ng/mL||95% Confidence Interval|Geometric Mean
2702873|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2702860|NCT01223352|Primary|Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan|"Daily exposure was measured by the area under the plasma concentration-time curve over a period of 24 hours [AUC(0-24)].~Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. AUC(0-24) was calculated as a multiple of AUCtau, which is the AUC over a dosing interval (AUCtau x 2 for the b.i.d. dosing regimen and AUCtau x 3 for the t.i.d. regimen). As the smallest dose unit was 8 mg (1/4 tablet), it was not possible to achieve the exact target dose of 2 mg/kg. Therefore, AUC(0-24) was corrected to 2 mg/kg (target dose) [AUC(0-24c)]."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per-protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2702861|NCT01223235|Secondary|Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers|Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5mm.|Up to 24 months||||months (Progression Free Survival)||95% Confidence Interval|Median
2702862|NCT01223235|Secondary|Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine|"when given in the presence of bevacizumab~Patients must have IgM titer >1:80, or a fourfold increase in prevailing antibody titer if present at baseline. Twenty-one patients would be accrued, and if >8 of 21 patients should meet these criteria for three or more antigens based on the immune response criteria, the study would be considered positive."|1 year||||% of participants|||Number
2702863|NCT01223235|Primary|Number of Participants With Adverse Events|Toxicities evaluated by CTCAE version 4.0|1 year||||Participants|||Count of Participants
2702864|NCT01223196|Other Pre-specified|Percentage (%) of Haemoglobin A1C|HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC).|6 months||||Percentage (%) of HbA1c||Standard Error|Mean
2702865|NCT01223196|Secondary|Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle.|The activity of TACE is measured by detecting the release of a fluorogenic synthetic substrate of TACE and measuring in a fluorometer. It is expressed in Fluorescence Units (F.U.)|6 months|These individuals completed both the baseline and all intermediate and the end of study visits.|||Tace Activity in F.U./mg prot||Standard Error|Mean
2702866|NCT01223196|Primary|Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp|"Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment.~The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)"|6 months|M/I|||Mg. of glucose/kg body w./mUxl ins.||Standard Error|Mean
2702867|NCT01223183|Primary|Mucociliary Clearance Rate After Hypertonic Saline Inhalation|The clearance rate of Tc-SC after the inhalation of hypertonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the hypertonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
2702868|NCT01223183|Primary|Mucociliary Clearance Rate After Isotonic Saline Inhalation|The clearance rate of Tc-SC after the inhalation of isotonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the isotonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
2702869|NCT01223183|Primary|Absorptive Clearance Rate After Hypertonic Saline Inhalation|The absorption rate of In-DTPA after the inhalation of hypertonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the hypertonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
2702870|NCT01223183|Primary|Absorptive Clearance Rate After Isotonic Saline Inhalation|The absorption rate of Indium 111 diethylenetriaminepentaacetic acid (In-DTPA) in the airways after the inhalation of isotonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the isotonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
2702871|NCT01223027|Secondary|Pre-dose Concentration in Plasma in Dovitinib|Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.|Week 2 Day 5, Week 4 Day 5, Week 6 Day 5|Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one dose of dovitinib and had at least one evaluable post-Baseline dovitinib concentration measurement.|||ng/ml||Standard Deviation|Mean
2702872|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2702886|NCT01222715|Other Pre-specified|Progression-free Survival|Progression-free survival data will be explored using Kaplan Meier analysis. Associations between this outcome and each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.|Up to 5 years|||||||
2702874|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores|The Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).|from date of randomization, at least 2 score units|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2702875|NCT01223027|Secondary|Time to Definitive Worsening of Karnofsky Performance Status (KPS)|Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.|from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier|Full Analysis Set (FAS) consited of all randomized patients.|||Months||95% Confidence Interval|Median
2702876|NCT01223027|Secondary|Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review|Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.|||Percentage of Participants|||Number
2702877|NCT01223027|Secondary|Progression Free Survival (PFS) Per Investigator's Radiology Review|PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2702878|NCT01223027|Secondary|Overall Survival (OS)|Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.|until at least 386 deaths are documented in the clinical database.|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2702879|NCT01223027|Primary|Progression Free Survival (PFS) Per Independent Central Radiology Review|Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.|Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2702880|NCT01223001|Secondary|Hopkins Verbal Learning Test|To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.|9 months|||||||
2702881|NCT01223001|Primary|Hamilton Rating Scale for Depression|To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.|9 months|Analysis was not conducted. Study was terminated before interim analysis. Raw data is stored in a secure location, but not able to be accessed.||||||
2702882|NCT01222884|Secondary|Change in Hemoglobin Concentration||6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
2702883|NCT01222884|Primary|Ability to Maintain Hemoglobin Level|The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.|Baseline to 6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.|||percentage of participants|||Number
2702884|NCT01222871|Primary|Nasal Endoscopic Exam Findings .|nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.|2 weeks, 6 weeks, 12 weeks were not collected from any participant.|No participant started because study was terminated.||||||
2702885|NCT01222832|Primary|Rate of Infection|Number of participants without infections on post-op visits 90 days.|90 days||||Participants|||Count of Participants
2702888|NCT01222715|Other Pre-specified|Clinical Response|The data reported in 2 groups will be summarized using numbers and percentages of patients in each stratum and at each time point (baseline, after course 2, at the time of best response and end of therapy or progressive disease, whichever comes first). A binomial generalized estimating equation (GEE) model will be fitted to the data. The variables in the model will be time, treatment group and a biomarker. The beta coefficient of the biomarker will quantify the strength of the association between clinical response and the biomarker, beyond the association of the outcome to the other variables.|Up to 5 years|||||||
2702889|NCT01222715|Other Pre-specified|Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site|These known risk factors will be compared to genomic features like gene and ribonucleic acid (RNA) expression values, as well as combinations of the two and splice variants of known genes, in order to identify those features most related to treatment resistance and poor outcome (overall survival and failure-free survival) using a Cox proportional hazards model of gene expression with cross validation.|Up to 5 years|||||||
2702890|NCT01222715|Other Pre-specified|Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment|First, the distributions of these markers will be compared at 'end of 2 cycles' between treatments using a 2-independent sample non-parametric test. The mean will also be modeled for each of these markers (or a transformation of the marker to near normality) as a function of time and treatment using GEEs which are designed to take into account the internal correlation of repeated measurements taken on the same subject. Associations between progression-free survival and changes in each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.|Baseline up to day 42|||||||
2702891|NCT01222715|Other Pre-specified|Biomarker Levels|Biomarker data will be summarized for each response category, at each time point using either means and standard deviations or medians and ranges.|Up to 36 weeks|||||||
2702892|NCT01222715|Secondary|Response Rate (CR + PR)|Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.|From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.|Only eligible participants with overall response evaluated were analyzed.|||Proportion of participants||95% Confidence Interval|Number
2702893|NCT01222715|Primary|Rate of Dose-Limiting Toxicities|The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays > 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis > 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP).|From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.|Only eligible participants were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2702894|NCT01222715|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 1 year in the study.|1 year|Only eligible participants were analyzed.|||Probability||95% Confidence Interval|Number
2702895|NCT01222689|Secondary|Number of Patients With Dose Modifications and Reason for Dose Modification.|Tabulation of the reasons for dose modification with number of patients|Up to final day of study treatment|Numbers in tabulation total to more than 18 because patients often had 2 or more reasons that prompted dose reduction. For example: Nausea/Vomiting + diarrhea (3), fatigue + diarrhea (2), rash + hypertension (1), rash + diarrhea (1), fatigue + Nausea/Vomiting (1)|||participants|||Number
2702896|NCT01222689|Primary|Survival at 24 Weeks|Percent survival at 24 weeks (6 months)|24 weeks||||percentage of participants|||Number
2702897|NCT01222689|Other Pre-specified|Plasma Biomarkers Potentially Predictive of Dual MEK/EGFR Inhibition|"The association between candidate plasma biomarkers of interest, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response.~Specifically, correlation of the relative change in allelic frequency of mutations present in both pre-treatment and on-treatment blood samples versus percent change in CA19-9."|Up to 2 years|Patients who had non-germline mutations (circulating cell-free DNA) represented in both their pre-treatment blood and on-treatment blood samples.|||R^2|||Number
2702898|NCT01222689|Other Pre-specified|Circulating Tumor Cell (CTC) Analysis|The association between baseline CTC numbers, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response will be evaluated. The association between expression level of protein markers in CTC with biopsy samples using Pearson's correlation and by unsupervised hierarchical clustering of samples using Pearson correlation as the distance metric will be assessed. Association of longitudinal protein markers in CTC with patient OS will be evaluated using the joint models of longitudinal observations.|Up to 2 years|Data was not collected.||||||
2702899|NCT01222689|Other Pre-specified|Protein Expression Levels in Pretherapeutic Core Biopsies|Logistic regression models will be used to associate baseline protein markers and best objective response. Cox models will be used to associate baseline protein markers with overall and progression-free survival. Each selected protein markers will be evaluated individually and ranked by the corresponding p-values. Combinations of markers will also be explored.|Up to 2 years|Data was not collected.||||||
2702900|NCT01222689|Secondary|Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Tabulation of type of adverse events (AE) and the incidence of grade 3 and 4 for each AE|Up to 30 days after completion of study treatment||||events|||Number
2703013|NCT01222104|Secondary|Impact of Guided Access on Use of Closure Device.|The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.|30 days|Percentage of procedures with devices deployed|||% of procedures using a closure device|Procedures||Number
2702901|NCT01222689|Secondary|Objective Radiographic Response by RECIST Criteria|"Patient's best overall response will be tabulated by level; proportions of complete response (CR) and of CR+partial response will be calculated along with 95% confidence intervals.~Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR, >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR."|Up to 2 years|There were no complete or patial responses by RECIST (stable disease, partial response, or complete response) amongst the 46 participants|||participants|||Number
2702902|NCT01222689|Secondary|CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement)|The proportion of patients with CA19-9 response.|Up to 2 years|Patients with baseline levels > 2 x ULN CA19-9 measurement|||percentage of participants|||Number
2702903|NCT01222689|Secondary|Progression-free Survival (PFS)|"Calculated according to the method of Kaplan and Meier. Actual and estimated probability of being alive and progression-free, along with a 95% confidence interval, will be calculated.~Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(Macdonald et al.):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used. Progressive Disease is defined as a 20% or higher increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)."|From first dose of study treatment to the date of objective progression, or death due to cancer or unknown cause, or to the date of withdrawal from the trial from unknown reasons, assessed up to 2 years||||months||95% Confidence Interval|Median
2702904|NCT01222689|Primary|Overall Survival (OS)|Survival will be calculated according to the method of Kaplan and Meier. Both actual and estimated probability of being alive (along with a 95% confidence interval) at 24 weeks (6 months) and for any multiple of 6 months will be calculated for which the number of uncensored subjects is not smaller than 10.|Up to 2 years||||months||95% Confidence Interval|Median
2702905|NCT01222585|Primary|Volume of Distribution|Volume of Distribution (L/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.|||L/kg||Full Range|Median
2702906|NCT01222585|Primary|Clearance|Clearance (L/h/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.|||L/h/kg||Full Range|Median
2702907|NCT01222585|Primary|Multiple Dose Minimum Concentration|Multiple Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.|||mg/L||Full Range|Median
2702908|NCT01222585|Primary|Multiple Dose Maximum Concentration|Multiple Dose Maximum Concentration (mg/L)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the multiple dose PK parameter.|||mg/L||Full Range|Median
2702909|NCT01222585|Primary|Loading Dose Minimum Concentration|Loading Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.|||mg/L||Full Range|Median
2702910|NCT01222585|Primary|Loading Dose Maximum Concentration|Loading Dose Maximum concentration (Cmax)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.|||mg/L||Full Range|Median
2702911|NCT01222585|Primary|Area Under the Curve at Steady State|Area under the curve at steady state (AUCss)|pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate this PK parameter.|||mg*hr/L||Full Range|Median
2702912|NCT01222572|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.~DLTs were defined as follows (CTCAE v4.0):~Grade 2 non-hematologic toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage~Grade 3 non-hematologic toxicities considered to be a direct result of therapy:~Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 4 non-hematologic toxicities: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophagitis (not due to mediastinal irradiation unrelated to the stereotactic boost), esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 5 non-hematologic toxicity: Any"|7-week chemoradiotherapy period and the subsequent 8-week recovery period|All treated participants who received at least one dose of the study drug and were evaluable for DLT.|||participants with DLT|||Number
2702913|NCT01222533|Other Pre-specified|VPB Singles|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702927|NCT01222533|Secondary|Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)|Tmax,ss is the time from dosing to the maximum concentration of tiotropium in plasma-venous blood at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.|||hours||Full Range|Median
2702914|NCT01222533|Other Pre-specified|VPB Pairs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702915|NCT01222533|Other Pre-specified|VPB Runs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702916|NCT01222533|Other Pre-specified|VPB Total|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702917|NCT01222533|Other Pre-specified|SVPB Singles|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702918|NCT01222533|Other Pre-specified|SVPB Pairs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702919|NCT01222533|Other Pre-specified|SVPB Runs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702920|NCT01222533|Other Pre-specified|SVPB Total|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
2702921|NCT01222533|Other Pre-specified|Mean Heart Rate (HR)|"Mean HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||bpm||Standard Deviation|Mean
2702922|NCT01222533|Other Pre-specified|Maximum Heart Rate (HR)|"Maximum HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded).|||bpm||Standard Deviation|Mean
2702923|NCT01222533|Secondary|Minimum Plasma Concentration at Steady-state (Cmin,ss)|Cmin,ss is the minimum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2702924|NCT01222533|Secondary|Renal Clearance at Steady-state (CL R,0-6h,ss)|Renal clearance of the drug over the time interval 0 to 6 hours at steady-state. CL R,0-6h,ss was calculated as the quotient of Ae0-6h,ss and AUC0-6h,ss.|Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.|PK Set. All patients with analysable data.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2702925|NCT01222533|Secondary|Pre-dose Plasma Concentration at Steady-state (Cpre,ss)|Cpre,ss is the measured concentration of tiotropium in plasma before dosing at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)|PK Set. All patients with analysable data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2704552|NCT01211600|Secondary|Intraoperative Trial Details - Duration of Operation and Skin Closure|Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure|Time of Cesarean||||Minutes||Inter-Quartile Range|Median
2702928|NCT01222533|Secondary|Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)|AUC0-1h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 1 hour post-dose at steady-state. AUC0-1h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2702929|NCT01222533|Secondary|FVC at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
2702930|NCT01222533|Secondary|FEV1 at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data.|||Liter||Standard Error|Mean
2702931|NCT01222533|Secondary|FVC AUC0-3h at the End of Each Treatment Period|FVC AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
2702932|NCT01222533|Secondary|FVC AUC0-6h at the End of Each Treatment Period|FVC AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
2702933|NCT01222533|Secondary|Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period|Defined as the pre-dose FVC measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
2702934|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period|FEV1 AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.|||Liter||Standard Error|Mean
2702935|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period|FEV1 AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.|||Liter||Standard Error|Mean
2702936|NCT01222533|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period|Defined as FEV1 measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|Full analysis set (FAS) with imputed data. FAS includes all patients in the treated set who have analysable data for at least one efficacy endpoint during the relevant crossover period.|||Liter||Standard Error|Mean
2702937|NCT01222533|Primary|Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)|AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. No PK data for Placebo. The low number of non-missing AUC0-6h,ss results for the Tio R 1.25 and Tio R 2.5 cohorts is due to the exclusion of results below the limit of quantification.|||pg*h/ml||Geometric Coefficient of Variation|Geometric Mean
2702938|NCT01222533|Primary|Maximum Plasma Concentration at Steady-state (Cmax,ss)|Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|Pharmacokinetic (PK) Set. This analysis set includes all patients in the treated set who had at least one blood sample drawn or one urine sample collected for PK analysis. Patients with an important protocol violation relevant to the PK population were excluded. No PK data for placebo. All patients with analysable data.|||pg/ml||Geometric Coefficient of Variation|Geometric Mean
2702939|NCT01222520|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Participants|||Number
2702940|NCT01222520|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Percentage of participants|||Number
2702941|NCT01222520|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Percentage of participants|||Number
2702942|NCT01222520|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP ≥140 mmHg at reference baseline|||Percentage of participants|||Number
2702943|NCT01222520|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Percentage of participants|||Number
2702960|NCT01222390|Secondary|Aesthetic Outcomes|Aesthetic outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years|||||||
2702944|NCT01222520|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
2702945|NCT01222520|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|Full analysis set (FAS)|||mmHg||Standard Error|Least Squares Mean
2702946|NCT01222507|Primary|Brain Speed Test|This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.|Initial study visit|The number of subjects who completed the study according to protocol.|||units on a scale||95% Confidence Interval|Median
2702947|NCT01222494|Other Pre-specified|Aberrant Behavior Checklist (ABC)|Change From Baseline in Aberrant Behavior Checklist - Irritability Subscale at 16 Weeks|Baseline and 16 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 16 data.|||units on a scale||Standard Deviation|Mean
2702948|NCT01222494|Primary|Carotid Artery Intima Media Thickness (CIMT)|9-13-MHZ B-mode Carotid Ultrasound will be used to assess intima media thickness at baseline and following 16 weeks of participation in a behavioral weight loss intervention.|Baseline and 16 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 16 data.|||millimeters||Standard Deviation|Mean
2702949|NCT01222494|Primary|Proton Density Fat Fraction (PDFF)|1H Magnetic Resonance Spectroscopy (MRS) of liver will be used to assess intracellular triglyceride content at baseline and following 16 weeks of participation in a behavioral weight loss intervention.|Baseline and 16 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 16 data.|||percent||Standard Deviation|Mean
2702950|NCT01222494|Primary|DEXA-measured Adiposity|Dual-Energy X-Ray Absorptiometry (DEXA) will be used to assess body fat at baseline and following 16 weeks of participation in a behavioral weight loss intervention.|Baseline and 16 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 16 data.|||kilograms||Standard Deviation|Mean
2702951|NCT01222416|Secondary|Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.||48 months|There were insufficient number of patients who had both MRI and PET performed to allow for meaningful statistical comparisons.||||||
2702952|NCT01222416|Primary|The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)|The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the|up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)|19 Patients had the scanned data at two time points: prior treatment and at the end of treatment.|||microcuries/g/(millicuries/kg)||95% Confidence Interval|Median
2702953|NCT01222403|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.|The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.|||participants|||Number
2702954|NCT01222403|Primary|Number of Subjects Reporting Unsolicited AEs After Vaccination.|The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.|||participants|||Number
2702955|NCT01222403|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.|The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 4 after vaccination|Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data.|||participants|||Number
2702956|NCT01222390|Primary|Breast Projection|The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).|1.5 years||||percentage loss of projection|Participants|Standard Deviation|Mean
2702957|NCT01222390|Secondary|Location of Volume Change|3-D photos will be taken to assess the location of volume and contour changes in the breast.|1.5 years|||||||
2702958|NCT01222390|Secondary|Emotional Outcomes|Emotional outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years|||||||
2702959|NCT01222390|Secondary|Complication Rate|Complications may include hematoma, seroma, infection, implant migration, inflammation or explantation.|1.5 years|||||||
2704553|NCT01211600|Secondary|Number of Participants With Primary Versus Repeat Cesarean|Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)|At randomization.||||Participants|||Count of Participants
2702961|NCT01222286|Secondary|Secondary Anti-tumor Activity|"any change of M-protein in serum occurring during the study (>25 percentage increase in level of serum M-protein)~progression to active Multiple Myeloma~Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder :~Development of new soft tissue plasmacytomas or bone lesions~Hypercalcemia (> 11mg/100ml)~Decrease in hemoglobin of > 2g/100ml~Rise in serum creatinine by 2 mg/100ml or more"|from start to end of study (14 months)||||Participant|||Number
2702962|NCT01222286|Secondary|Pharmacodynamics of IPH2101|biological activity of IPH2101 on KIR occupancy at End of Treatment|from start to end of study (14 months)|all subjects who received at least 1 dose of IPH2101|||% of occupancy of killer like receptor||Full Range|Mean
2702963|NCT01222286|Secondary|Safety Assessment|adverse events, physical examination and biological changes during the whole clinical trial.|Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months|The safety population included all subjects who received at least 1 dose of IPH2101|||Patients with any AE|||Number
2702964|NCT01222286|Primary|Rate of Patients Achieving an Objective Response|The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.|from start to end of study (14 months)|The ITT population included all randomized subjects.|||participants|||Number
2702965|NCT01222273|Secondary|Change in Patient Aspergillus Specific IgE Levels|To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce aspergillus specific IgE levels by the end of the 24-week period|6 months||||kUA/I||Standard Deviation|Mean
2702966|NCT01222273|Secondary|Change in Patient Total IgE Levels|To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce total IgE levels by the end of the 24-week period|6 months||||IU/mL||Standard Deviation|Mean
2702967|NCT01222273|Primary|Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells|To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce Aspergillus induced IL-13 responses in peripheral CD4+ T-cells. Response confirmed for each individual patient and recorded as number of participants with response.|6 months||||Participants|||Count of Participants
2702968|NCT01222260|Secondary|Median Overall Survival (OS)|Survival is assessed as time to death from first day of treatment The OS function for response-evaluable will be estimated using the product-limit (Kaplan-Meier) estimator, along with 95% confidence bounds. The median survival will be estimated from the survival function. The analysis will be repeated on all patients who receive any therapy.|Up to 2 years||||months||95% Confidence Interval|Median
2702969|NCT01222260|Secondary|Organ Response Rate (ORR)|The proportion of response-evaluable patients experiencing ORR will be estimated, with a 95% exact binomial confidence interval. Amyloid-related organ response will be evaluated on the basis of the accepted criteria described: Kidneys: 30% reduction or drop below 0.5 g in 24-hour urine protein excretion in the absence of progressive renal insufficiency. Heart: N-terminal pro b-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide response (>30% and >300 ng/L decrease in patients with baseline NT-proBNP ≥ 650 ng/L or New York Heart Association (NYHA) class response (≥ 2 class decrease in subjects with baseline NYHA class 3 or 4). Liver: 50% decrease of an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm. Neuropathy: improvement supported by clinical history, neurologic exam, orthostatic vital signs, resolution of severe constipation or reduction of diarrhea to less than 50% of previous movements/day.|Up to 2 years||||Participants|||Count of Participants
2702970|NCT01222260|Secondary|Overall Hematologic Response Rate (OHR)|The proportion of response-evaluable patients experiencing OHR will be estimated, with a 95% exact binomial confidence interval. Overall hematologic response rate as defined by normalization of the free light chain levels and ratio, negative serum and urine immunofixation OR reduction in the difference between involved and uninvolved free light chains (dFLC) to <4 mg/dL.|Up to 2 years||||Participants|||Count of Participants
2702971|NCT01222260|Primary|Partial Hematologic Response (PHR) Rate|Only patients who have received at least 2 cycles of therapy are eligible for response assessment. The proportion of patients with PHR two months post-treatment will be estimated, with a 95% exact binomial confidence interval. Partial response is defined as the reduction of the difference between involved and uninvolved free light chains (dFLC) of ≥ 50% OR a reduction of ≥ 50% of the M-protein if M-spike is ≥ 0.5 g/dL.|Up to 2 years||||Participants|||Count of Participants
2702972|NCT01222247|Secondary|Median Length of Maternal Hospital Stay|Median length of maternal hospital stay in days|Delivery through hospital discharge|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||days||Inter-Quartile Range|Median
2702973|NCT01222247|Secondary|Hours From Randomization to Delivery|Median interval of hours from randomization to delivery|Randomization through delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Hours||Inter-Quartile Range|Median
2702974|NCT01222247|Secondary|Maternal Outcomes (Participant-based)|Chorioamnionitis: clinical diagnosis and a body temperature of at least 100.4 degrees F., Endometritis: persistent postpartum temperature greater than 100.4 degrees F with uterine tenderness, cesarean delivery|Labor and delivery through 72 hours post partum||||Participants|||Count of Participants
2702975|NCT01222247|Secondary|Median Length of Hospital Stay|Median length of maternal hospital stay following delivery|Duration of hospital stay following delivery up to 2 weeks|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||days||Inter-Quartile Range|Median
2702976|NCT01222247|Secondary|Length of NICU or Nursery Stay|Includes need for NICU or intermediate care admission and length of stay if admitted. For analysis purposes, death before discharge is assigned maximum rank|Delivery through hospital discharge up to 3 weeks|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702977|NCT01222247|Secondary|Number of Neonates With Hypothermia|Rectal temperature < 36 C at any time|Delivery through discharge up to 3 weeks|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702978|NCT01222247|Secondary|Neonatal Hyperbilirubinemia|Peak total bilirubin of at least 15 mg% or the use of phototherapy.|Delivery||||Participants|||Count of Participants
2702979|NCT01222247|Secondary|Neonatal Feeding Difficulty|Inability of the neonate to take all feeds (po), i.e. requiring gavage feeds or IV supplementation.|Delivery to 36 hours post delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702980|NCT01222247|Secondary|Time Until First Neonatal Feeding|Median length of time from delivery until the first neonatal feeding|Delivery to 36 hours post delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||hours||Inter-Quartile Range|Median
2702981|NCT01222247|Secondary|Number of Neonates With Hypoglycemia|Glucose < 40 mg per deciliter (2.2 mmol per liter) at any time|Delivery through hospital discharge up to 3 weeks|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702982|NCT01222247|Secondary|Neonatal Morbidity Composite|A composite endpoint of morbidities known to be affected by steroid administration will also be evaluated. Specifically, this composite will include RDS, intraventricular hemorrhage (IVH), and NEC|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702983|NCT01222247|Secondary|Number of Neonates With Intraventricular Hemorrhage|Grade 3 or 4 Intraventricular Hemorrhage|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702984|NCT01222247|Secondary|Number of Infants With Neonatal Sepsis|Clinical suspicion of systemic infection with a positive blood, cerebral spinal fluid, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evience of cardiovascular collapse or an X-ray confirming infection.|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702985|NCT01222247|Secondary|Number of Neonates With Necrotizing Enterocolitic (NEC)|Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.|Delivery||||Participants|||Count of Participants
2702986|NCT01222247|Secondary|Gestational Age at Delivery|Number of neonates delivered at ≤ 34 weeks 6 days, between 35 weeks 0 days and 35 weeks 6 days, between 36 weeks 0 days and 36 weeks 6 days, between 37 weeks 0 days and 38 weeks 6 days, or on or after 39 weeks 0 days|Delivery||||Participants|||Count of Participants
2702987|NCT01222247|Secondary|Birth Weight Less Than 10th Percentile|Neonates whose birth weight is less than the 10th percentile at delivery|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702988|NCT01222247|Secondary|Birth Weight|Weight in grams at delivery|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||grams||Standard Deviation|Mean
2702989|NCT01222247|Secondary|Neonatal Death After 72 Hours of Delivery|Neonatal death after 72 hours of life but before hospital discharge.|72 hours after delivery through hospital discharge up to 3 weeks|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702990|NCT01222247|Secondary|Number of Neonates With Pulmonary Air Leak|Neonatal pulmonary air leak syndrome|72 hours post delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702991|NCT01222247|Secondary|Neonatal Outcome Composite|Transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and apnea|72 hours of life|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702992|NCT01222247|Secondary|Number of Neonates Needing Surfactant Administration|Administration of surfactant for neonatal respiratory treatment|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702993|NCT01222247|Secondary|Neonates With Pneumonia|Neonatal pneumonia|by 72 hours of life|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702994|NCT01222247|Secondary|Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen|Infants requiring supplemental oxygen of more than 0.21 for the first 28 days of life|28 days of life|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702995|NCT01222247|Secondary|Number of Infants With Neonatal Apnea|Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline.|72 hours of life|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2720921|NCT01091948|Secondary|Intubation Difficulty Score|Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);|from start of intubation to successfully intubated||||units on a scale||Inter-Quartile Range|Median
2702996|NCT01222247|Secondary|Number of Neonates With Transient Tachypnea of the Newborn|TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age. TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings|by 72 hours after delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702997|NCT01222247|Secondary|Number of Neonates With Respiratory Distress Syndrome|Respiratory distress defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis) with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates|Delivery|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2702998|NCT01222247|Secondary|Neonates Needing Immediate Resuscitation After Birth|Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen|Within the first 30 minutes of birth||||Participants|||Count of Participants
2702999|NCT01222247|Secondary|Number of Neonates With Severe Respiratory Complication,|A severe respiratory complication was defined as any of the following occurrences within 72 hours after birth: CPAP or high-flow nasal cannula for at least 12 hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 24 hours, mechanical ventilation, stillbirth or neonatal death, or the need for ECMO. Except for the duration of CPAP or high-flow nasal cannula and the duration of a fraction of inspired oxygen of 0.30 or more, the criteria for a severe respiratory complication overlap with those of the primary outcome.|72 hours of life|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2703000|NCT01222247|Primary|Neonatal Composite Outcome|Need for respiratory support: Continuous positive airway pressure (CPAP) or humidified high-flow nasal cannula (HHFNC) for greater than or equal to 2 hours or more in the first 72 hours, or fraction of inspired oxygen (FiO2) greater than or equal to 0.30 for 4 hours or more in the first 72 hours, or mechanical ventilation in the first 72 hours, or Extracorporeal membrane oxygenation (ECMO) Stillbirth, or neonatal death less than 72 hours of age|72 hours of life|The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).|||Participants|||Count of Participants
2703001|NCT01222234|Primary|Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol||8 weeks of therapy|The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.|||ng/ml||Standard Deviation|Mean
2703002|NCT01222234|Primary|Monocyte Protein Expression|Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression|8 weeks of therapy|The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.|||relative fluorescence units||Standard Deviation|Mean
2703003|NCT01222195|Primary|Number of Patients With a Transfusion Independence Response|Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.|Over six 28-day cycles (approximately 168 days)|Analysis was per protocol.|||participants|||Number
2703004|NCT01222117|Secondary|The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.|The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.|30 days|Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)|||percentage of participants|||Number
2703005|NCT01222117|Primary|The Proportion of Subjects With >50% Thrombolysis|The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.|5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)|In groups A-D, G and H, 8 subjects were excluded (EOT arteriogram missing or not read, did not receive >=90% of dose). In groups I and J, 11 subjects were excluded (BOC not inserted/appropriately inflated, missing an arteriogram). In group F, 1 subject was not dosed and 4 subjects were excluded (did not receive >=90% of dose).|||percentage of participants|||Number
2703006|NCT01222104|Secondary|Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.|30 days||||% of procedures with minor vasc comp.|Procedures||Number
2703007|NCT01222104|Secondary|Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).|30 days||||% of procedures with MVCs|Procedures||Number
2703008|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device|Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.|30 days||||% of procedures achieving hemostasis|Procedures||Number
2703009|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device|Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device|30 days||||% of procedures using closure device|Procedures||Number
2703010|NCT01222104|Secondary|Rate of Minor Vascular Complications by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.|30 days||||% of procedures with minor vasc comp.|Procedures||Number
2703011|NCT01222104|Secondary|Rate of Major Vascular Complications (MVCs) by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).|30 days||||% of procedures with MVCs|Procedures||Number
2703012|NCT01222104|Secondary|Impact of Guided Access on Achieving Target Puncture Location.|The influence of fluoroscopy and/or ultrasound guided access on puncture location.|30 days|Deployed subjects with readable angiograms|||% within target zone|||Number
2703014|NCT01222104|Secondary|Rate of Minor Vascular Complications|"The following are defined as a minor vascular complication:~Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;~Ipsilateral hematoma >10 cm;~Ipsilateral pseudoaneurysm without intervention;~Ipsilateral arteriovenous fistula;~Ipsilateral deep vein thrombosis;~Local access site infection without prolonged hospitalization"|30 days||||% of procedures with minor vasc comp.|Procedures||Number
2703015|NCT01222104|Secondary|Time to Hemostasis|Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.|Procedure||||% of procedures|Procedures||Number
2703016|NCT01222104|Primary|Rate of Major Vascular Complications|"Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.~The following are defined as a major vascular complication:~Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;~Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;~Access site related bleeding requiring transfusion;~New ipsilateral lower extremity ischemia requiring surgical intervention;~Retroperitoneal bleeding;~Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;~Access related complication that results in extended hospital stay;~Death"|30 days|5 subjects underwent vascular closure with Angio-Seal on right and left sides.|||Percentage of Procedures|Procedures||Number
2703017|NCT01222091|Secondary|Objective Opioid Withdrawal Scale (OOWS)|OOWS: Is a 13-item instrument of documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score = 13, minimum score = 0. Lower scores correspond to fewer symptoms.|Pretreatment [90 min prior to 60-min REM infusion]; 30 min prior to 60-min REM infusion; 15 and 40 min after start of 60-min REM infusion; 5, 15, and 75 minutes after finish of 60-min REM infusion)||||units on a scale||Standard Deviation|Mean
2703018|NCT01222091|Primary|Percent Change From Baseline in Size (Area) of Secondary Hyperalgesia After Cessation of Remifentanil Infusion, a Measure of Opioid-induced Hyperalgesia (OIH).|A slightly modified version of a previously described model of secondary hyperalgesia was used. Two copper wires contained in a microdialysis catheter were inserted in parallel over a length of 5 mm into the dermis of the right volar forearm. The wires were connected to a constant current stimulator controlled by a pulse generator to deliver rectangular and monophasic pulses with a duration of 0.5 mg at 2 Hz. Over a period of 15 min, the current was increased by targeting a pain rating of 5 on an 11-point numeric rating scale (0 = no pain and 10 = maximum tolerable pain) until the hyperalgesic area surrounding the stimulation site was fully established. Once the area was established, the current was held constant. Percent change from baseline in size (area) of secondary hyperalgesia after cessation of remifentanil infusion was calculated per group.|Baseline; 15 min post remifentanil (REM) infusion; 60 min post REM infusion||||percentage of change|||Number
2703019|NCT01222078|Secondary|Terminal Phase Half-life (Thalf) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||hours||Full Range|Median
2703020|NCT01222078|Secondary|Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||hours||Full Range|Median
2703021|NCT01222078|Secondary|Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||Hours times nanograms per milliliter||Standard Deviation|Mean
2703022|NCT01222078|Secondary|Time to Cmax (Tmax) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||hours||Full Range|Median
2703023|NCT01222078|Secondary|Maximum Observed Serum Concentration (Cmax) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||ng/mL||Standard Deviation|Mean
2703024|NCT01222078|Secondary|Mean Individual Serum Concentrations of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2703025|NCT01222078|Secondary|Mean Saturation of CD3 Antigen on Peripheral Blood T Cells|Assessment of CD3 antigen was planned to be done on Day 1, 4 and 8 of first treatment course. The data was planned to be presented with unit Molecules of Equivalent Soluble Fluorochrome (MESF). Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||MESF||Standard Deviation|Mean
2703026|NCT01222078|Secondary|Mean Circulating CD4+ and CD8+ Subset Counts|Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||Percent total lymphocytes||Standard Deviation|Mean
2703027|NCT01222078|Secondary|Mean Circulating Peripheral T Lymphocytes Count|Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Day 1, 4 and 8 of each treatment course|Safety Population|||GI/L||Standard Deviation|Mean
2703099|NCT01221441|Secondary|Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia|The number of participants that had a change in pain severity as measured by the incidence and dose of analgesic medications|2 Years|Patients taking at least one analgesia medication|||participants|||Number
2703028|NCT01222078|Primary|Proportion of Anti-otelixizumab Neutralizing Antibodies|Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.|Up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703029|NCT01222078|Primary|Mean Serum Levels of Anti-otelixizumab Binding Antibodies|Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.|Up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703030|NCT01222078|Primary|Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts|Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||Percent total lymphocytes||Standard Deviation|Mean
2703031|NCT01222078|Primary|Mean Change in Circulating Peripheral T Lymphocytes|Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||GI/L||Standard Deviation|Mean
2703032|NCT01222078|Primary|Mean Change in CD4+ and CD8+ T-cell Counts|CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||Percent total lymphocytes||Standard Deviation|Mean
2703033|NCT01222078|Primary|Mean Change in Total Lymphocyte Count|Total lymphocyte count was planned to be analyzed up to Month 24.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study this endpoint was not collected.||||||
2703034|NCT01222078|Primary|Mean Epstein-Barr Virus (EBV) Viral Load|Levels of EBV were assessed periodically using Quantitative Polymerase Chain Reaction. If a participant had an EBV viral load of >=10,000 copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs) at any visit, the test was repeated as soon as possible to confirm this result. If the result was confirmed, the test was repeated weekly for 2 weeks or until the count decreases to < 10,000 copies per 10^6 PBMCs, whichever was longer. The EBV Load remained zero throughout the study. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination. The viral load was to measure using unit copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs)|Up to Month 24|Safety Population|||Copies per 10^6 PBMCs||Standard Deviation|Mean
2703035|NCT01222078|Primary|Mean Change From Baseline in Red Blood Cell Count|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703036|NCT01222078|Primary|Mean Change From Baseline in Hemoglobin Value|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703037|NCT01222078|Primary|Mean Change From Baseline in Glycosylated Hemoglobin Value|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703038|NCT01222078|Primary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703039|NCT01222078|Primary|Mean Change From Baseline in Value of Estradiol|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703040|NCT01222078|Primary|Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703041|NCT01222078|Primary|Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703042|NCT01222078|Primary|Mean Change From Baseline in Value of Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Follicle Stimulating Hormone, Gamma Glutamyl Tranferase and Lactate Dehydrogenase|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703043|NCT01222078|Primary|Mean Change From Baseline in Value of Albumin and Total Protein|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703044|NCT01222078|Primary|Number of Participants With Values Outside the Normal Range for Vitals|Vital included assessment of SBP, DBP, respiration rate, heart rate and temperature were assessed at sitting position. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination.|Up to Month 24|Safety Population|||Participants|||Number
2703045|NCT01222078|Primary|Mean Change From Baseline in Heart Rate|Heart rate was recorded at sitting position at Baseline and post-treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703046|NCT01222078|Primary|Mean Change From Baseline in Temperature|Temperature was recorded at sitting position at Baseline and post treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703047|NCT01222078|Primary|Mean Change From Baseline in Respiration Rate|Respiration rate was assessed at sitting position at Baseline and post-treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703048|NCT01222078|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was assessed at sitting position at Baseline and 1 to 7 hours of post-infusion of first treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
2703049|NCT01222078|Primary|Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Study was early terminated and participant withdrew on study Day 164.|Up to Month 24|Safety Population consisted of participants who had received at least one dose of infusion.|||Participants|||Number
2703050|NCT01221948|Secondary|Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.|"Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: (very much improved to marked worsening). This assessment was completed by the neurologist."|52 weeks post first lead implantation||||percentage of participants|||Number
2703051|NCT01221948|Primary|Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.~Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|26 weeks post first lead implantation||||units on a scale||Standard Deviation|Mean
2703052|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on|The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients' ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).|12, 26 and 52 weeks post first lead implantation||||percentage change||Standard Deviation|Mean
2703053|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.|"The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions:~mobility~activities of daily living~emotional well-being~stigma~social support~cognitions~communication~bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure."|12, 26 and 52 weeks post first lead implantation||||percentage change||Standard Deviation|Mean
2703054|NCT01221948|Secondary|Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.|"Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record on, on with troublesome dyskinesia, off, and asleep times for three consecutive days."|12, 26 and 52 weeks post first lead implantation||||hours/day||Standard Deviation|Mean
2703055|NCT01221948|Secondary|Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation|All parkinsonian medications will be converted to Levodopa dose equivalents (LED) and baseline dose will be compared with dose taken at 12, 26 and 52 weeks post implantation|12, 26 and 52 weeks post first lead implantation|40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52|||mg||Standard Deviation|Mean
2703056|NCT01221948|Secondary|Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items.~Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52."|12, 26 and 52 weeks post first lead implantation||||units on a scale||Standard Deviation|Mean
2703057|NCT01221948|Secondary|Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.~Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|12 and 52 weeks post first lead implantation||||units on a scale||Standard Deviation|Mean
2703058|NCT01221857|Secondary|Non-relapse Mortality|Proportion of patients who had non-relapse mortality at 100 days.|100 days||||proportion of patients|||Number
2703059|NCT01221857|Secondary|Proportion of Patients Who Developed Acute GvHD Grade II-IV and III-IV|"Acute GvHD was assessed from transplantation (day 0) until day 99 post-transplant or more frequently as clinically indicated. GvHD was classified according to the Glucksberg Classification (Glucksberg, Storb et al. 1974).~The overall grade of GvHD, however, was determined by an assessment of skin disease, liver disease and gastrointestinal manifestations."|180 days||||proportion of patients|||Number
2703060|NCT01221857|Primary|Proportion of Patients With Neutrophil Engraftment|Neutrophil engraftment was defined as achieving an Absolute Neutrophil Count (ANC) of ≥500 mm3 for 3 consecutive measurements on different days by day 42 inclusive (the day of engraftment was defined as the first of these 3 days). The ANC recovery must be of donor origin documented by peripheral blood chimerism assays indicating less than or equal to 10% host cells in peripheral blood.|42 days|Patients transplanted with NiCord|||proportion of patients|||Number
2703061|NCT01221857|Primary|Acute Toxicity Associated With the Infusion of NiCord|Acute toxicity associated with the infusion of NiCord will be measured by adverse events within 24 hours post-infusion, defined as the acute toxicity period. Known adverse events associated with myeloablation and cord blood transplant were specifically monitored including fever, chills, allergic reaction/hypersensitivity, anaphylaxis, sinus bradycardia, sinus tachycardia, hypertension, hypotension, nausea, vomiting, diarrhea, dyspnea, hypoxia, hemoglobinuria, infection, flank pain and any other skin, CNS, cardiac, pulmonary or other toxicity manifestations.|180 days post-transplant|Patients transplanted with NiCord|||Participants|||Count of Participants
2703062|NCT01221753|Secondary|4-y Overall Survival Rate|4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.|Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).|The analysis dataset is comprised of all treated patients. Since all patients have not been followed for survival for 5 years the 4-year rate is provided. All data provided was based on chart review and not from case report forms.|||percentage of participants|||Number
2703063|NCT01221753|Primary|2-Year Local-Regional Control Rate|2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.|The study was terminated early due to weak accrual. Clinical outcome data were not accessible for results reporting due to the designation of study completed at the institution.||||||
2703064|NCT01221727|Secondary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
2703065|NCT01221727|Secondary|Summary of Percent Change From Baseline to Day 16 for Serum C-Telopeptide Concentration|This table summarizes percent change from baseline to day 16 for serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.|||percentage|percentage|Inter-Quartile Range|Median
2703066|NCT01221727|Primary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
2703067|NCT01221727|Secondary|Summary of Serum C-Telopeptide Concentration|This table summarizes serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.|||ng/mL|concentration|Inter-Quartile Range|Median
2703187|NCT01220557|Secondary|Diabetes Self-Efficacy Scale|A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.|6 Month Follow up|||||||
2703068|NCT01221727|Secondary|Summary of Serum Denosumab Concentration|This table summarizes serum Denosumab for Midazolam with Denosumab group. The Lower Limit Of Quantification (LLOQ) is 20 ng/mL. On Day 2 (pre-dose), the true value is below LLOQ, and is treated as 0 in the analysis.|Baseline (day 2 pre-dose) to day 16|Serum Denosumab will be collected for subjects in Midazolam with Denosumab group only. The analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum Denosumab concentrations are determinable when assessed.|||ng/mL|concentration|Standard Deviation|Median
2703069|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for PK Cmax Parameter for Midazolam Only Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng/mL|concentration|Standard Deviation|Mean
2703070|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam Only Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng*hr/mL|area|Standard Deviation|Mean
2703071|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for PK Maximum Observed Plasma Concentration (Cmax) Parameter for Midazolam With Denosumab Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng/mL|concentration|Standard Deviation|Mean
2703072|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam With Denosumab Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng*hr/mL|area|Standard Deviation|Mean
2703073|NCT01221727|Secondary|Ratio of PK AUC Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
2703074|NCT01221727|Primary|Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
2703075|NCT01221623|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 52|Composite responder analysis is based on the ITT population.|||participants|||Number
2703076|NCT01221623|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
2703077|NCT01221623|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy is based on the mITT population.|||centimeters||Standard Deviation|Mean
2703078|NCT01221623|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703079|NCT01221623|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703080|NCT01221623|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703081|NCT01221623|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicated a responder.|Week 52|Efficacy is based on the mITT population.|||participants|||Number
2703082|NCT01221623|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703083|NCT01221623|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat (mITT) population.|||percentage of curvature change||Standard Deviation|Mean
2703084|NCT01221597|Secondary|Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score|A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie's disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity.|Week 52|Efficacy analysis is based on the mITT population.|||Number of participants|||Number
2703085|NCT01221597|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population. This population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
2703086|NCT01221597|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||centimeters||Standard Deviation|Mean
2703087|NCT01221597|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703088|NCT01221597|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703089|NCT01221597|Secondary|Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703090|NCT01221597|Secondary|A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease|A responder was defined as a subject who recorded his Peyronie's disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question.|Week 52|Efficacy analysis was based on the mITT population.|||Number of particpants|||Number
2703091|NCT01221597|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2703092|NCT01221597|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat population (mITT).|||percentage of curvature change||Standard Deviation|Mean
2703093|NCT01221441|Secondary|Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years|Overall assessment of general health as determined by scoring use an SF-36 Questionnaire (Range 0-100 with higher scores better - indicating less disability)|2 Years|Patients with completed SF-36 questionnaire at 104 weeks|||scores on a scale||95% Confidence Interval|Least Squares Mean
2703094|NCT01221441|Secondary|Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests|The number of participants with changes in clinical hematology, chemistry, and urinalysis test results through 2 years that were considered Adverse Events|2 Years|All patients|||participants|||Number
2703095|NCT01221441|Secondary|The Incidence and Severity of Adverse Events in Treated Patients|The incidence and severity of adverse events assessed through 104 weeks (2 years) after dose administration|2 Years|All patients receiving treatment with either active or placebo|||participants|||Number
2703096|NCT01221441|Secondary|The Number of Patients Experiencing Injection Site Reactions Related to Treatment|The number of patients with observations of the administration site deemed related to treatment with either active or placebo, including arthralgia, swelling, irritation, pain, stiffness or abnormalities|2 Years|All participants receiving placebo or active treatment|||participants|||Number
2703097|NCT01221441|Secondary|The Incidence of Total Knee Arthroplasty|Quantification of the incidence of total knee arthroplasty of the treated knee subsequent to treatment with TissueGene-C|2 Years|All patients that participated in the study|||participants|||Number
2703098|NCT01221441|Secondary|Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years|Assessment of knee function as determined by the Lower Extremity Functional Scale (LEFS); change from baseline to 2 years (Range 0-80 with higher scores signifying lower difficulty in performing knee functions)|2 Years|Patients that completed 2-year follow-up|||scores on a scale||95% Confidence Interval|Least Squares Mean
2703188|NCT01220557|Secondary|CES-D Score|Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.|6 month follow up|||||||
2703100|NCT01221441|Secondary|Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire|Change in pain severity (on a scale from 1 to 4) from baseline to 2 years as measured by a questionnaire (lower scores better)|2 Years|Patients that completed 2 year follow-up|||scores on a scale||Standard Deviation|Mean
2703101|NCT01221441|Secondary|Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year|Comparison of pre-procedure 3T MRI scans to those obtained at months 12 following dose administration by an independent radiographic reviewer. Evaluations will be scored using Whole Organ Magnetic Resonance imaging Score (WORMS) Cartilage Morphology Subscore (Range 0-6, with higher scores being worse)|1 Year|Patients with available baseline and 1-year MRIs|||scores on a scale||95% Confidence Interval|Least Squares Mean
2703102|NCT01221441|Secondary|Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years|Measurement to assess outcomes of various chondral disorders of the knee determined by the Lysholm Knee Scale (Range 0-100 with higher scores better). Linear mixed model used for analysis.|2 Years||||scores on a scale||95% Confidence Interval|Least Squares Mean
2703103|NCT01221441|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years|Symptoms, pain and functionality of the knee joint as determined by Total Score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (Range 0-100 with higher scores indicating healthier outcomes). Linear mixed model used for analysis.|2 Years||||scores on a scale||95% Confidence Interval|Least Squares Mean
2703104|NCT01221441|Primary|Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year|Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.|1 Year|Patients with available baseline and 1 year VAS score|||units on a scale||95% Confidence Interval|Least Squares Mean
2703105|NCT01221441|Primary|Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year|Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.|1 Year|Patients with available baseline IKDC scores|||scores on a scale||95% Confidence Interval|Least Squares Mean
2703106|NCT01221363|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.|Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up|Change in measured HDL from baseline and 6 months follow-up||||mmol/Liter||Standard Deviation|Mean
2703107|NCT01221363|Primary|Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up|"Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time.~Change in sitting time from baseline to 6 months follow up was evaluated."|7 days of measurement / change in sitting time from baseline and 6 months follow-up|Within group difference|||Hours per day||Standard Deviation|Mean
2703108|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|60 days||||units on a scale||Standard Deviation|Mean
2703109|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|Baseline||||units on a scale||Standard Deviation|Mean
2703110|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|60 days||||units on a scale||Standard Deviation|Mean
2703111|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|Baseline||||units on a scale||Standard Deviation|Mean
2703112|NCT01221350|Secondary|Inflammatory IL-4 Sputum Levels at Endpoint|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of IgE in B cells. IL-4 was measured by ELISA.|60 days||||pg/mL||Standard Deviation|Mean
2703113|NCT01221350|Secondary|Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of immunoglobulin E (IgE) in B cells. IL-4 was measured by ELISA.|Baseline||||pg/mL||Standard Deviation|Mean
2703114|NCT01221350|Secondary|Induced Sputum Eosinophils at Endpoint|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|60 days||||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
2703115|NCT01221350|Secondary|Induced Sputum Eosinophils at Baseline|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|Baseline||||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
2703116|NCT01221350|Primary|Spirometric FEF Values at Endpoint|Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|60 days||||Liters/sec||Standard Deviation|Mean
2703117|NCT01221350|Primary|Spirometric FEF Values at Baseline|Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|Baseline||||Liters/sec||Standard Deviation|Mean
2703118|NCT01221350|Primary|Spirometric FEV1 Values at Endpoint|Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|60 days||||Liters||Standard Deviation|Mean
2703119|NCT01221350|Primary|Spirometric FEV1 Values at Baseline|Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|Baseline||||Liters||Standard Deviation|Mean
2703120|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Endpoint|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products.|60 days||||nmol/mg||Standard Deviation|Mean
2703121|NCT01221350|Primary|Spirometric FVC Values at Endpoint|Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|60 days|Per protocol|||Liters||Standard Deviation|Mean
2703122|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Baseline|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products|Baseline||||nmol/mg||Standard Deviation|Mean
2703123|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint|Change in the induced sputum of antioxidant parameters GSH and GSSG levels after 60 days of treatment. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|60 days||||ratio||95% Confidence Interval|Mean
2703124|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline|Induced sputum of GSH and GSSG levels at baseline. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|Baseline||||ratio||95% Confidence Interval|Mean
2703125|NCT01221350|Primary|Spirometric FVC Values at Baseline|Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|Baseline||||Liters||Standard Deviation|Mean
2703126|NCT01221311|Primary|Early Clinical Success|Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.|Post-stent removal (up to one year after enrollment)|The number of participants analyzed is lower than the number of patients randomized, due to patients who dropped out of the study before all stents were removed.|||Participants|||Count of Participants
2703127|NCT01221298|Secondary|Time to Virologic Relapse Through 24 Weeks Post-treatment|Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.|||Days||95% Confidence Interval|Mean
2703128|NCT01221298|Secondary|Time to Failure to Suppress or Rebound During Treatment|The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||Days||Standard Error|Mean
2703129|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2703130|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2703131|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2703132|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
2703133|NCT01221298|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4 through Week 12|For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.|||percentage of participants|||Number
2703134|NCT01221285|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Percent antibody binding||Standard Error|Mean
2703135|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Number
2703136|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Number
2703137|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Number
2703138|NCT01221285|Primary|Number of Reported Treatment-related Serious Adverse Events (SAEs)|Number of SAEs reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat|||Events|||Number
2703139|NCT01221285|Primary|Number of Reported Treatment-related Adverse Events (AEs)|Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat|||Events|||Number
2703140|NCT01221272|Secondary|Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible TPD was derived as the exercise TPD at baseline and at the end of Periods 1 and 2 minus the resting TPD at baseline. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set|||units on a scale||Standard Error|Mean
2703189|NCT01220557|Secondary|Diabetes Distress Scale (DDS)|Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.|6 month follow up|||||||
2703141|NCT01221272|Secondary|Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible PDS was derived as the exercise PDS at baseline and at the end of Periods 1 and 2 minus the resting PDS at baseline. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set|||percentage of myocardium||Standard Error|Mean
2703142|NCT01221272|Secondary|Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2|Perfusion defect severity was assessed for each participant as the percentage of the 17 myocardium segments with a relative perfusion defect score of 3 or 4 on a 0-4 scale. Segment scores are: 0 = normal perfusion; 1 = mild reduction in counts-not definitely abnormal; 2 = moderate reduction in counts-definitely abnormal; 3 = severe reduction in counts; 4 = absent uptake (lower scores correspond to less severity and higher scores correspond to increased severity). A lower percentage means fewer segments have severely reduced blood flow. Measurements were obtained by SPECT imaging following exercise at baseline and at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set|||percentage of segments||Standard Error|Mean
2703143|NCT01221272|Primary|Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment|TPD is a score that measures the overall impact of a region of decreased myocardial blood flow, incorporating both the amount and severity of the decreased flow. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2703144|NCT01221272|Primary|Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment|PDS is the amount (percent) of the myocardium with decreased blood flow. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by gated single photon emission computed tomography (SPECT) imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set: 61 randomized and treated participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software|||percentage of myocardium||Standard Error|Least Squares Mean
2703145|NCT01221233|Primary|Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms|Percent change (baseline-6 weeks)/baseline X100% was calculated for each participant in each intervention arm and then these differences were compared using a Mann-Whitney U test since data did not meet parametric assumptions.|Baseline and 6 Weeks|Analyses were only completed on participants who completed the randomized clinical trial.|||% change||Inter-Quartile Range|Median
2703146|NCT01221181|Primary|Number of Patients With Change in Proteinuria or Serum Creatinine Over Treatment Period|This is designed to measure response to eculizumab through clinical and histological data, including a reduction in serum creatinine or in proteinuria, or histopathologic improvement. Any reduction in serum creatinine and/or proteinuria was included in our descriptive analysis.|One year||||Participants|||Count of Participants
2703147|NCT01221090|Secondary|Quality of Life (QOL)|Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health.|12 months|Participants were included if they completed the 12-mo follow-up questionnaire. They also had to have answered questions pertaining to quality of life. Missing responses were not included.|||Number of days||Standard Deviation|Mean
2703148|NCT01221090|Secondary|Diabetes-related Behaviors|Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care.|12 months|Those who completed a questionnaire at baseline and at their 12-month visit were included. Also, they had to have answered questions regarding self-care activities on both surveys since the calculated mean was the average difference in days within the past 7 that individuals participated in self-care activities between 12-months and baseline.|||Days (e.g., Avg diff 12mo vs baseline)||Standard Deviation|Mean
2703149|NCT01221090|Secondary|Patient Self-reported Perceived Health Status||12 months|Perceived health status was collected using a questionnaire administered during the 12-month follow-up visit. Individuals who did not complete the questionnaire during the follow-up visit or who refused to answer the question were not included in the analysis.|||participants|||Number
2703150|NCT01221090|Secondary|BMI|Body mass index|12 months|BMI was computed from height & weight measurements from the 12-month follow-up (f/u) visit. Those unable to come in had height and weight abstracted from their EHRs. Measures recorded fell within the range of 10 days prior to and 45 days after participants’ f/u visit dates. Those missing this information was not included in the analysis.|||kg/m^2||Standard Deviation|Mean
2703151|NCT01221090|Primary|HbA1c|Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation.|12 months|A participant was included in the analysis if he/she had a HbA1c value collected. A longitudinal analysis was performed, with participants contributing one or more HbA1c values to the model. As such, all participants had at least one HbA1c value and were therefore included in the model.|||percentage of gycosylated HbA1c|Participants|Standard Deviation|Mean
2703190|NCT01220557|Secondary|Summary of Diabetes Self-Care Activities (SDSCA)|The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.|6 month|||||||
2703191|NCT01220557|Secondary|Diabetes Empowerment Score (DES)|Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.|6 month follow up|||||||
2703152|NCT01220999|Secondary|Number of Subjects With Best Overall Metabolic Response|Metabolic response to CS-1008 was assessed by fluorodeoxyglucose positron emission tomography (18^F-FDG PET) at Screening, Day 15, and at the End of Cycle 1/End of Study visit (Days 44-50). For each FDG-PET performed, the maximum standardized uptake value (SUVmax) corrected for body weight for all target lesions >2 cm identified on CT imaging was calculated using region of interest (ROI). The ROI was determined with the aid of the anatomical detail provided by the CT scan. Tumor metabolic response to CS-1008 was assessed by 18^F-FDG PET/CT calculated using the target lesion with the greatest baseline SUVmax, and was categorized according to the European Organization for Research and Treatment of Cancer (EORTC) guidelines (Young et al. Eur J Cancer 1999;35:1773-82).|Up to 50 days|The population comprises all subjects who received at least 1 dose of study treatment and had at least 1 applicable post-baseline response evaluation.|||Participants|||Count of Participants
2703153|NCT01220999|Secondary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using appropriate imaging and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, at Screening, at the end of every odd-numbered cycle (i.e., Cycles 1, 3, and 5, as applicable), and at the time of treatment discontinuation. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria (Eisenhauer et al. Eur J Cancer 2009;45:228-47).|Up to 7 months|The population comprises all subjects who received at least 1 dose of study treatment and had at least 1 applicable post-baseline response evaluation.|||Participants|||Count of Participants
2703154|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Maximum Concentration by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).|Up to 50 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.|||μg/mL||Standard Deviation|Mean
2703155|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Total Clearance by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).|Up to 50 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.|||mL/hr||Standard Deviation|Mean
2703156|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Area Under the Curve by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).|Up to 50 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.|||hr*μg/mL||Standard Deviation|Mean
2703157|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Volume of Central Compartment by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).|Up to 50 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.|||mL||Standard Deviation|Mean
2703158|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).|Up to 50 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.|||hours||Standard Deviation|Mean
2703159|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Maximum Concentration by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).|Up to 36 days|The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.|||μg/mL||Standard Deviation|Mean
2703160|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Total Clearance by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).|Up to 36 days|The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.|||mL/hr||Standard Deviation|Mean
2703161|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Area Under the Curve by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).|Up to 36 days|The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.|||hr*μg/mL||Standard Deviation|Mean
2703162|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Volume of Central Compartment by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).|Up to 36 days|The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.|||mL||Standard Deviation|Mean
2703163|NCT01220999|Primary|Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008|The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).|Up to 36 days|The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.|||hours||Standard Deviation|Mean
2703164|NCT01220999|Primary|Mean Tumor Uptake of 111^In-CS-1008 Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions|Tumor localization was assessed using gamma camera imaging performed on Days 7/8 and 42/43. Dosimetry calculations were performed to determine the tumor localization properties of 111^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111^In-CS-1008 were performed based on conjugate view images obtained from quantitative whole body images obtained at multiple time points. MIRD formalism was used in the calculation of doses.|Up to 43 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had tumor uptake.|||% of injected dose/g of organ||Standard Deviation|Mean
2703165|NCT01220999|Primary|Number of Subjects With Tumor Uptake of 111^In-CS-1008 in Target Lesions Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions|"Tumor localization was assessed using gamma camera imaging performed after the initial infusion of 111^In-CS-1008 on Day 1 and then on Days 2, 4/5, 7/8, and 11/12 (collectively, After Day 1 Infusion in the table) and after the second infusion of 111^In-CS-1008 on Day 36 and then on Days 37, 39/40, and 42/43 (collectively, After Day 36 Infusion in the table). Dosimetry calculations were performed to determine the tumor localization properties of 111^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111^In-CS-1008 were performed based on conjugate view images obtained from quantitative whole body images obtained at multiple time points. MIRD formalism was used in the calculation of doses."|Up to 43 days|The population comprises all subjects who completed study requirements through Cycle 1 (Day 43). One patient in Cohort 3 was prematurely withdrawn from the study on Day 36 due to symptomatic deterioration secondary to progressive disease (radiologically documented) and did not complete Cycle 1.|||participants|||Number
2703166|NCT01220973|Primary|PSA Response|PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.|6 months|A total of 27 patients were enrolled but only 26 were evaluable as one patient withdrew consent prior to starting therapy.|||Participants|||Count of Participants
2703167|NCT01220869|Secondary|Cumulative Probability of no PSA Failure|The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.|Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.|||Percentage of participants||95% Confidence Interval|Mean
2703168|NCT01220869|Other Pre-specified|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.|From Day 28 to Day 168|The PP analysis set included all participants from the FAS analysis set without major protocol violations.|||Percentage of participants||95% Confidence Interval|Mean
2703169|NCT01220869|Secondary|Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28|Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28|From Day 0 to Day 28|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset|||Percentage change of PSA||Inter-Quartile Range|Median
2703170|NCT01220869|Secondary|Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3|Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3|Day 3|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset|||Percentage of participants||95% Confidence Interval|Mean
2724827|NCT01062763|Primary|Change of of Systolic Blood Pressure|Change of systolic blood pressure from baseline to study end at four months.|4 months|Analysis by intention to treat using LOCF|||mm Hg||95% Confidence Interval|Mean
2703171|NCT01220869|Primary|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.|From Day 28 to Day 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.|||Percentage of participants||95% Confidence Interval|Mean
2703172|NCT01220739|Primary|Percentage of Participants With Modified Rankin Scale (0 - 1)|Measures the degree of disability or dependence in the daily activities. Minimum score = 0 (best outcome - No symptoms); Maximum Score = 6 (worse outcome - dead)|90 Days from Stroke Onset||||percentage of participants|||Number
2703173|NCT01220739|Primary|Symptomatic Intracranial Hemorrhages||36 hours from tPA initiation||||participants|||Number
2703174|NCT01220726|Primary|International Prostate Symptom Score (IPSS)|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic)|From Baseline to Day 270||||units on a scale||Inter-Quartile Range|Median
2703175|NCT01220726|Primary|Maximum Flow Rate (Qmax)|Qmax is the the maximum recorded flow rate|From Baseline to Day 270||||mL/s||Standard Deviation|Mean
2703176|NCT01220726|Primary|Postvoid Residual Volume (PVR)|Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.|From Baseline to Day 270||||mL||Standard Deviation|Mean
2703177|NCT01220726|Primary|International Consultation on Incontinence Questionnaire (ICIQ)|ICIQ is a brief validated instrument that is comprehensive for the assessment of incontinence and measures frequency, severity and impact on quality of life. There are a total of 23 items. The overall score ranges from 1-84 with greater values indicating increased symptom severity. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient.|From Baseline to Day 270||||units on a scale||Inter-Quartile Range|Median
2703178|NCT01220726|Primary|Quality of Life (QoL)|Quality of Life (QoL) is from the ICIQ-QAB (international Consultation of Incontinence Overactive Bladder) Questionnaire. It is scored 25-160 and those with higher scores have higher impact on quality of life.|From Baseline to Day 270||||scores on a scale||Inter-Quartile Range|Median
2703179|NCT01220726|Primary|Urgency|This measured the degree of urinary urgency using a 3-day voiding diary. Patients were assessed for the number of urgency episodes they had by answering yes or no.|From Baseline to Day 270||||episodes||Inter-Quartile Range|Median
2703180|NCT01220726|Primary|Urinary Frequency|This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270|From Baseline to Day 270||||urinations||Inter-Quartile Range|Median
2703181|NCT01220609|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients.|||months||95% Confidence Interval|Median
2703182|NCT01220609|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and treated patients|||months||95% Confidence Interval|Median
2703183|NCT01220609|Primary|Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0||Every cycle until completion of study treatment up to 30 days after stopping study treatment|Eligible and evaluable patients.|||Participants|||Count of Participants
2703184|NCT01220609|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2703185|NCT01220557|Secondary|Evaluation of the Diabetes Education Course|Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).|6 month Follow up|||||||
2703186|NCT01220557|Secondary|Treatment Satisfaction / Problem Areas in Dealing With Diabetes|Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.|6 Month Follow up|||||||
2703192|NCT01220557|Secondary|Hypoglycaemia Awareness Score|The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.|6 month|||||||
2703193|NCT01220557|Secondary|Diabetes Knowledge|To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.|6 month|||||||
2703194|NCT01220557|Primary|Changes in Glycemic Control Measured by A1c|Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.|6 month||||Changes in A1c in percentage points||Standard Deviation|Mean
2703195|NCT01220466|Other Pre-specified|Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction|Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.|6 Months|Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power|||percentage of eyes|Participants|95% Confidence Interval|Number
2703196|NCT01220466|Other Pre-specified|Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40||6 Months|Percentage of eyes with BSCVA worse than 20/40|||percentage of eyes|Participants|95% Confidence Interval|Number
2703197|NCT01220466|Other Pre-specified|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|Percent of eyes that lost more than 2 lines of BSCVA.|||percentage of eyes|Participants|95% Confidence Interval|Number
2703198|NCT01220466|Other Pre-specified|Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D||6 months|Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D|||percentage of eyes|Participants|95% Confidence Interval|Number
2703199|NCT01220466|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.||6 months|UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better|||percentage of eyes|Participants|95% Confidence Interval|Number
2703200|NCT01220414|Primary|Time for Subject to Reach Pain Threshold||Baseline||||seconds||Standard Deviation|Mean
2703201|NCT01220401|Primary|Past Week Nightmare Frequency|This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).|pre, one week, two months||||nightmares/week||Standard Deviation|Mean
2703202|NCT01220401|Secondary|Beck Depression Inventory|This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 - 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.|Baseline, 1 week, 2 months||||units on a scale||Standard Deviation|Mean
2703203|NCT01220401|Primary|Clinician Administered PTSD Scale|"This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 - 4). This study utilized the FI/I2 rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis.~Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD."|pre, one week, two months||||units on a scale||Standard Deviation|Mean
2703204|NCT01220401|Primary|Number of Nights With Nightmares|This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).|pre, one week, two months||||nights/week||Standard Deviation|Mean
2703205|NCT01220297|Secondary|Veno-occlusive Disease (VoD)|Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant.|100 days post-transplant||||Participants|||Count of Participants
2703206|NCT01220297|Secondary|Overall Survival|Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years.|2 years||||Days||Full Range|Median
2703207|NCT01220297|Secondary|Disease-free Survival (DFS)|Assessed as survival without recurrence of disease|2 years||||Participants|||Count of Participants
2703208|NCT01220297|Secondary|Acute GvHD (Grade 3 to 4)|"Assessed as the incidence of grade 3 to 4 acute GvHD at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage"|100 days post-transplant||||Participants|||Count of Participants
2703209|NCT01220297|Primary|Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)|"Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage"|100 days post-transplant||||Participants|||Count of Participants
2703210|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Participants|||Number
2703211|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Participants|||Number
2703212|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Participants|||Number
2703213|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Participants|||Number
2703214|NCT01220180|Secondary|Number of Participants With PGIC Scale for NeP in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Participants|||Number
2703215|NCT01220180|Secondary|Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Participants|||Number
2703216|NCT01220180|Secondary|Number of Participants With CGIC Scale for NeP in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Participants|||Number
2703217|NCT01220180|Secondary|Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Participants|||Number
2703218|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
2703219|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
2703220|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
2703221|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6|Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
2703222|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
2703223|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
2703224|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
2703225|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6|Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
2703226|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in PP Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.|||Percentage of participants|||Number
2703227|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in ITT Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.|||Percentage of participants|||Number
2703228|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.|||Percentage of participants||95% Confidence Interval|Number
2703229|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.|||Percentage of participants||95% Confidence Interval|Number
2703230|NCT01220128|Primary|Number of Subjects With Breast Cancer Pathological Response|The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present.|During Phase II of the study period, up to Year 3|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703231|NCT01220128|Primary|Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703232|NCT01220128|Primary|Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703233|NCT01220128|Primary|Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703234|NCT01220128|Primary|Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703235|NCT01220128|Primary|Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703236|NCT01220128|Primary|Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703237|NCT01220128|Primary|Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703238|NCT01220128|Primary|Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703239|NCT01220128|Primary|Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703240|NCT01220128|Primary|Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade||During the treatment period and post 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703241|NCT01220128|Primary|Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703242|NCT01220128|Primary|Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703243|NCT01220128|Primary|Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703244|NCT01220128|Primary|Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703245|NCT01220128|Primary|Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703246|NCT01220128|Primary|Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703247|NCT01220128|Primary|Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703248|NCT01220128|Primary|Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703249|NCT01220128|Primary|Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703250|NCT01220128|Primary|Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703251|NCT01220128|Primary|Number of Subjects With Anemia, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703252|NCT01220128|Primary|Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703253|NCT01220128|Primary|Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703254|NCT01220128|Primary|Number of Subjects With Serious Adverse Events SAE(s)|A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE.|From Week 0 to Week 26/32|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703255|NCT01220128|Primary|Number of Patients With Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|During the 31-day (Days 0-30) following vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703256|NCT01220128|Primary|Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response|At post-GSK2302024A/placebo Dose 4 (Week 13)|For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration. The main analysis for the Phase|According-to-Protocol (ATP) Population for immunogenicity included all eligible patients who did not report major protocol deviation, who had at least received the first 4 doses of study product and provided a valid result for immunogenicity measurement within the 4 weeks following Dose 4.|||Subjects|||Number
2703257|NCT01220128|Primary|Number of Subjects With Severe Toxicities|"Severe toxicity was defined as follows:~A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo~A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks.~A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo.~A Grade 2 or higher allergic reaction occurring within 24 hours following the administration.~A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration.~A decrease in renal function at the time of administration that was considered as related or possibly related."|During the whole study period, up to Year 3|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
2703258|NCT01219985|Secondary|Lesions Uptake Measurement (SUVmax)|For each detected uptake (in Ungated or CT-based PET images), observers have to report the corresponding maximum standardized uptake value (SUVmax). The SUVmax was obtained automatically in a volume of interest encompassing the entire lesion.|Day 1|The number of participant has been determined on the basis of the annual possible recruitment in the institution to keep the study feasible.|||g/L||Standard Deviation|Mean
2703259|NCT01219985|Primary|Number of Detected Uptakes on PET Images|Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).|day 1|Patients who underwent liver resection|||number of real metastatic lesions|||Number
2703260|NCT01219959|Secondary|Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6|Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent||Standard Deviation|Mean
2703261|NCT01219959|Secondary|Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6|Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||grams||Standard Deviation|Mean
2703262|NCT01219959|Secondary|Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6|Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate),however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mL||Standard Deviation|Mean
2703263|NCT01219959|Secondary|Change From Baseline of MRI Body Composition at Month 6|Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used in this analysis. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mL||Standard Deviation|Mean
2703264|NCT01219959|Secondary|Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6|"The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0."|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Scores on a scale||Standard Deviation|Mean
2703265|NCT01219959|Secondary|Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6|"Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0."|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Score on a Scale||Standard Deviation|Mean
2703266|NCT01219959|Secondary|Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6|European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent Change||Standard Deviation|Mean
2703267|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6|Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||grams||Standard Deviation|Mean
2703268|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6|Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||cm||Standard Deviation|Mean
2703269|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6|Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||kg/m2||Standard Deviation|Mean
2703270|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6|Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||kg||Standard Deviation|Mean
2703271|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6|Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mg/dL||Standard Deviation|Mean
2703272|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6|Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||g/kg/day||Standard Deviation|Mean
2703273|NCT01219959|Secondary|Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6|Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||g/L||Standard Deviation|Mean
2703274|NCT01219959|Secondary|Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6|Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished.|Baseline and Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||participants|||Number
2703275|NCT01219959|Secondary|Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6|Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||pmol/L||Standard Deviation|Mean
2703276|NCT01219959|Secondary|Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6|Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||pg/mL||Standard Deviation|Mean
2703277|NCT01219959|Secondary|Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6|Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mg/dL||Standard Deviation|Mean
2703278|NCT01219959|Secondary|Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6|Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mmol/L||Standard Deviation|Mean
2703279|NCT01219959|Secondary|Number of Severe Hypoglycemic Event Requiring Medical Intervention|Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.|Baseline through Month 6 (End of Study)|Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||events|||Number
2703280|NCT01219959|Secondary|Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6|This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Analysis used data from prescription information of concomitant medications reported. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent Change||Standard Deviation|Mean
2703281|NCT01219959|Primary|Change From the Baseline Value in HbA1c at Month 3 and 6|HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.|||Percent Change||Standard Deviation|Mean
2703282|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2703283|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2703284|NCT01219933|Secondary|CDAI Score During the Interventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703285|NCT01219933|Secondary|SF-36 Subscale Scores During the Interventional Phase|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined."|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|ITT Population; n=number of participants analyzed for the given parameter at the specified time point.|||units on a scale||Standard Deviation|Mean
2703286|NCT01219933|Secondary|Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase|"36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined."|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703287|NCT01219933|Primary|Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks|The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)|Intent-to-Treat (ITT) population: all participants included in the interventional GC reduction phase of the study.|||percentage of participants||95% Confidence Interval|Number
2703288|NCT01219933|Primary|Type of GC Taken at the End of the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint|||percentage of participants|||Number
2703289|NCT01219933|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703290|NCT01219933|Secondary|SJC and TJC During the Interventional Phase|TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||joints||Standard Deviation|Mean
2703291|NCT01219933|Secondary|VAS for Pain (VAS-Pain) During the Interventional Phase|Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.|||mm||Standard Deviation|Mean
2703292|NCT01219933|Secondary|VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase|Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.|||mm||Standard Deviation|Mean
2703293|NCT01219933|Secondary|HAQ-DI During the Interventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined.|Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703308|NCT01219933|Secondary|Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2703294|NCT01219933|Secondary|DAS28-CRP During the Interventional Phase|DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703295|NCT01219933|Secondary|Time-Averaged GC Dose Changes During the Interventional Phase|"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9."|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; only participants who completed the study were included in the analysis.|||mg||Standard Deviation|Mean
2703296|NCT01219933|Secondary|Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; pnly those participants who completed the study at V9 were included in analysis.|||percentage of participants||95% Confidence Interval|Number
2703297|NCT01219933|Secondary|Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; only those participants who completed the study at V9 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2703298|NCT01219933|Secondary|Percentage of Participants Able to Start the GC Reduction Phase at V3|All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC.|V3 (7 months)|Safety Int (intervention) run-in: all participants eligible to enter the interventional phase at V2 and who had taken at least 1 dose of MP.|||percentage of participants||95% Confidence Interval|Number
2703299|NCT01219933|Secondary|Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population|||percentage of participants|||Number
2703300|NCT01219933|Secondary|Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase|The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events.|V1 and V2 (up to 6 months after V1)|Safety Obs Population|||participants|||Number
2703301|NCT01219933|Secondary|Median Dose of Tocilizumab During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population|||mg/kg||Full Range|Median
2703302|NCT01219933|Secondary|Median Time Interval Between V1 and V2|The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months.|V1 and V2 (up to 6 months after V1)|Safety Obs Population|||months||Full Range|Median
2703303|NCT01219933|Secondary|Clinical Disease Activity Index (CDAI) During the Noninterventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703304|NCT01219933|Secondary|DAS28-ESR During the Noninterventional Phase|DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703305|NCT01219933|Secondary|DAS28-CRP During the Noninterventional Phase|DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703306|NCT01219933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2703307|NCT01219933|Secondary|Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase|Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2703608|NCT01217840|Secondary|Hemoglobin A1C (HgbA1c) at Baseline and Week 24|HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.|Baseline; Week 24|Patients who completed the study were analyzed.|||Percentage of glycosylated hemoglobin||Standard Error|Mean
2703309|NCT01219933|Secondary|Number of Erosions During the NonInterventional Phase|In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||erosions||Standard Deviation|Mean
2703310|NCT01219933|Secondary|Percentage of Participants With Erosions During the NonInterventional Phase|In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2703311|NCT01219933|Secondary|Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission.|V1 and V2 (up to 6 months after V1)|Safety Obs population|||percentage of participants|||Number
2703312|NCT01219933|Secondary|Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA.|V1 and V2 (up to 6 months after V1)|Safety Obs Population|||percentage of participants|||Number
2703313|NCT01219933|Primary|Number of Participants With GC Switches During the Noninterventional Phase|During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint|||participants|||Number
2703314|NCT01219933|Primary|Median GC Dose Taken During the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.|V1 and V2 (up to 6 months after V1)|Safety obs population; n (number) equals (=) number of participants analyzed for a given parameter at a specified timepoint|||mg||Full Range|Median
2703315|NCT01219881|Secondary|Incidence of Coughing at Extubation|Effect of desflurane versus sevoflurane on the incidence of coughing at extubation using a standardized coughing scale|At extubation|Determined if patient passed eligibility and completed study.|||Participants|||Count of Participants
2703316|NCT01219881|Secondary|Time to Extubation|Time from gas discontinuation to eye extubation after eye opening|14 days|Determined if patient passed eligibility and completed study.|||Minutes||Standard Deviation|Mean
2703317|NCT01219881|Secondary|Difference in Time to Orientation|Difference in time to orientation as measured by Short Orientation Memory Concentration Test (SOMCT) between the desflurane group and the sevoflurane group|14 Days|Determined if patient passed eligibility and completed study.|||Minutes||Inter-Quartile Range|Median
2703318|NCT01219881|Primary|Recovery Time|Recovery Time after exposure to desflurane or sevoflurane considering time of emergence from anesthesia|14 Days|Determined if patients passed all eligibility and completed study.|||Minutes||Inter-Quartile Range|Median
2703319|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6|Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population|||participants|||Number
2703320|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6|Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol|||participants|||Number
2703321|NCT01219855|Secondary|Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population|Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.|Baseline to End of Treatment (6 weeks)|Per protocol population|||percentage of change from baseline||Standard Deviation|Mean
2703322|NCT01219855|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D at Week 6|Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population|||ng/mL||Standard Deviation|Mean
2703323|NCT01219855|Primary|Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)|Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.|6 weeks|Per protocol|||percentage of change from baseline||Standard Deviation|Mean
2703324|NCT01219855|Primary|Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).|The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.|6 weeks|Per protocol|||percentage of participants|||Number
2703346|NCT01218646|Primary|Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 0 and Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2703325|NCT01219777|Secondary|Toxicity and Response Rates Based on Imaging and Surgical Outcomes|Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months||||patients|||Number
2703326|NCT01219777|Primary|Tolerated Dose|To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.|Up to 6 months||||mg/m^2|||Number
2703327|NCT01219738|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participant will be followed up to 6 hours after budesonide dose||||percentage of change from baseline||Standard Error|Mean
2703328|NCT01219738|Primary|Airway Blood Flow (Qaw)|Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participants will be followed for 6 hours after budesonide dose||||percentage of change from baseline||Standard Error|Mean
2703329|NCT01219673|Primary|Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)|Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|10 weeks|No analysis was completed. Study terminated with low enrollment.||||||
2703330|NCT01218997|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study|A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.|up to 1 year|All subjects who received at least 1 dose of study drug are included in the safety population.|||Participants|||Number
2703331|NCT01218984|Primary|Slope Change From Baseline for Pupil Size|Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.|4 weeks (Baseline to Day 28)|Placebo hydromorphone challenge sessions were excluded from the analysis. Results for subjects who discontinued prior to Day 28 were not imputed.|||cm(2)/hr||Standard Deviation|Mean
2703332|NCT01218971|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 48 weeks (13 injections), not including base study|All participants who received at least 1 dose of study drug are included in the safety population.|||Participants|||Number
2703333|NCT01218958|Secondary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|24 weeks (Baseline to Week 24)||||Participants|||Number
2703334|NCT01218958|Primary|Percentage of Heavy Drinking Days Over the Treatment Period|Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.|Baseline through Week 24 (168 days)|The last post-baseline observation carried forward (LOCF) of each participant in the intent-to-treat population (all randomized participants who received at least 1 injection of study drug) were utilized for the primary efficacy analysis.|||Percentage of days|Days|Inter-Quartile Range|Median
2703335|NCT01218867|Secondary|In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|6 years|This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.||||||
2703336|NCT01218867|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately, 33 months and 25 days||||Participants|||Count of Participants
2703337|NCT01218867|Primary|Number of Participants With a Response to Therapy|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|5 years||||Participants|||Count of Participants
2703338|NCT01218802|Primary|Carotid IMT|changes in carotid IMT is a good measure for cardiovascular disease progression|96 weeks|The number of participants who received a final CIMT is less than the number of participants enrolled, due in part to study drop outs and/or invalid data measures.|||percentage change||Standard Deviation|Mean
2703339|NCT01218802|Primary|Bone Mineral Density (BMD)|Measured by change in bone DEXA from baseline to week 96|96 weeks|The total number of participants who received this outcome who had valid data is less than the total number of enrolled participants, due to drop outs before week 96 and/or invalid testing data from DEXA results.|||percentage of change||Standard Deviation|Mean
2703340|NCT01218659|Secondary|Annualized Rate Of Change From Baseline To Month 18 In eGFR By The Modification Of Diet In Renal Disease Equation|"The GFR estimated by the Modification Of Diet In Renal Disease equation (eGFR-MDRD) was calculated using the following equation: eGFR-MDRD = 175 x (Serum Creatinine)^(-1.154) x (Age)^(-0.203) x 1.212 (if participant's race is black or African American) x 0.742 (if participant is female).~The eGFR-MDRD from Baseline to Month 18 was analyzed using an ANCOVA model with the following factors as covariates: treatment group, sex, age, Baseline GFR (eGFR-CKD-EPI), and Baseline 24-hr urine protein."|Baseline to Month 18|mITT Population: All randomized participants with an α Gal-A mutation that is amenable to migalastat, based on the GLP HEK assay, who received at least 1 dose of study drug, had Baseline and postbaseline mGFR-iohexol values, and postbaseline measure of the estimated GFR using the CKD-EPI equation.|||mL/min/1.73 m^2/year||95% Confidence Interval|Least Squares Mean
2703341|NCT01218659|Primary|Annualized Rate Of Change From Baseline To Month 18 In eGFR|"The eGFR assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was calculated using the following:~eGFR-CKD-EPI = 141 x min (Serum Creatinine/κ,1)^(α) x max(Serum Creatinine/κ,1)^(-1.209) x 0.993^(Age) x 1.1018 (if female) x 1.159 (if African American or black) where: κ is 0.7 for females and 0.9 for males; α is -0.329 for females and -0.411 for males; min indicates the minimum of Serum Creatinine/κ or 1; max indicates the maximum of Serum Creatinine/κ or 1.~The annualized rate of change in eGFR-CKD-EPI from Baseline to Month 18 was analyzed using an ANCOVA model with the following factors as covariates: treatment group, sex, age, Baseline GFR (eGFR-CKD-EPI), and Baseline 24-hr urine protein. A threshold of <2.2 mL/min/1.73m^2/year was established to compare migalastat to ERT. This difference of 2.2 mL/min/1.73 m2/year is based on the smallest expected rate of decline in eGFR for participants treated with agalsidase alfa for 18 months."|Baseline to Month 18|mITT Population: All randomized participants with an α Gal-A mutation that is amenable to migalastat, based on the GLP HEK assay, who received at least 1 dose of study drug, had Baseline and postbaseline mGFR-iohexol values, and postbaseline measure of the estimated GFR using the CKD-EPI equation.|||mL/min/1.73 m^2/year||95% Confidence Interval|Least Squares Mean
2703342|NCT01218659|Primary|Annualized Rate Of Change From Baseline To Month 18 In Measured Glomerular Filtration Rate|To assess renal function, measured glomerular filtration rate (GFR) was measured by the plasma clearance of unlabeled iohexol (mGFR-iohexol), a non-ionic contrast agent. The annualized rate of change in mGFR-iohexol from Baseline to Month 18 was analyzed using an analysis of covariance (ANCOVA) model with the following factors as covariates: treatment group, sex, age, Baseline GFR (mGFR-iohexol), and Baseline 24-hour (hr) urine protein. A threshold of <2.2 milliliter (mL)/minute (min)/1.73 meter squared (m^2)/year was established to compare migalastat to ERT. This difference of 2.2 mL/min/1.73 m2/year is based on the smallest expected rate of decline in estimated glomerular filtration rate (eGFR) for participants treated with agalsidase alfa for 18 months.|Baseline to Month 18|mITT Population: All randomized participants with an α Gal-A mutation that is amenable to migalastat, based on the GLP HEK assay, who received at least 1 dose of study drug, had Baseline and postbaseline mGFR-iohexol values, and postbaseline measure of the estimated GFR using the CKD-EPI equation.|||mL/min/1.73 m^2/year||95% Confidence Interval|Least Squares Mean
2703343|NCT01218646|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.|"Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm.~Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity."|Day 0 up to day 21 post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.|||Participants|||Number
2703344|NCT01218646|Other Pre-specified|Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.|||Participants|||Number
2703345|NCT01218646|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)"|Day 21 post-vaccination|Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
2703347|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers."|Day 21 post-vaccination|Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
2703348|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2703349|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population|||Participants|||Number
2703350|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (<LLOQ or >ULOQ).|||Titers||95% Confidence Interval|Geometric Mean
2703351|NCT01218594|Primary|Response Rate (RR)|Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).|4 weeks after CCRT|Response rate (RR)include complete response and partial response.|||percentage of participants|||Number
2703352|NCT01218477|Secondary|Number of Participants With Grade 3-4 Abnormalities on Laboratory Test Results|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria of the National Cancer Institute from 1 (least severe) to 4 (life threatening). ANC (*10^9): Grade 3, <1.0- 0.5; Grade 4, <0.5. Hemoglobin (mmol/L): Grade 3, <4.9-4.0; Grade 4, <4.0. Platelet count (*10^9/L): Grade 3, <50.0-25.0; Grade 4, <25. WBCs (*10^9): Grade 3, <2.0-1.0; Grade 4, <1.0. Hypocalcemia (mmol/L): Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L): Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L): Grade 3, <3.0-2.5; Grade 4, <2.5. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Hypermagnesemia (mg/dL): Grade 3, >1.23-3.30; Grade 4, >3.30. Phosphorus (mmol/L): Grade 3, <0.6-0.3; Grade 4, <0.3. Lipase (*ULN): Grade 3, >2.0-5.0; Grade 4, >5.0.|Day 1 to Week 80|All participants who received at least 1 dose of study drug.|||Participants|||Number
2703353|NCT01218477|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment and may or may not be related to treatment. SAE=an untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. The following drug-related AEs occurring during the first 28 days of treatment with both agents were considered to be dose-limiting toxicities (DLTs): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite adequate medical intervention; ≥Grade 2 AE not controlled by medical intervention and requiring treatment interruption for >7 days.|Day 1 to Week 80, continuously, with observation for dose-limiting toxicities (DLTs) in Weeks 5-8|All participants who received at least 1 dose of study drug|||Participants|||Number
2703354|NCT01218477|Secondary|Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|MHR was defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR for CML-Adv criteria: white blood cell count (WBC) ≤upper limit normal; absolute neutrophil count (ANC) ≥1,000/mm^3; platelets ≥100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); basophils <5% in PB; myelocytes + metamyelocytes < 5% in PB; no extramedullary involvement; blasts must be <5%, if bone marrow assessment (BMA) performed. NEL had same criteria, but with lower thresholds for reconstitution of PB counts, as follows: Platelets ≥ 20,000/mm^3 or ANC >500/mm^3. Confirmed MHR obtained if these criteria met and maintained for ≥28 days. CHR for CML-CP criteria WBC ≤10,000/mm^3; platelets <450,000/mm^3; basophils <5% in PB; no blasts or promyelocytes in PB; myelocytes + metamyelocytes <5% in PB; no extramedullary involvement; blasts must be <5% if BMA performed. Confirmed CHR obtained if these criteria met and maintained for ≥28 days. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|Patients without complete hematologic response at dosing start date who received at least 4 weeks of dasatinib and who had at least 1 on-treatment evaluation of both peripheral blood counts and bone marrow cytogenetic response after at least 4 weeks on treatment.|||Percentage of participants||95% Confidence Interval|Number
2703355|NCT01218477|Secondary|Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|Cytogenetic response (CyR) was based on the proportion of Philadelphia chromosome-positive (Ph+) cells in metaphase analysis of bone marrow. Complete cytogenetic response (CCyR)=0 Ph+ cells; Partial CyR (PCyR)=1 to 35 Ph+ cells; Minor CyCR= 36-65 Ph+ cells; Minimal CyCR= 66-95 Ph+ cells; No response= >96 Ph+ cells. MCyR=CCyR + PCyR. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|All patients without CCyR at dosing start date who received at least 4 weeks of dasatinib and had at least 1 on-treatment cytogenetic evaluation of the bone marrow data after at least 4 weeks on treatment|||Percentage of participants||95% Confidence Interval|Number
2703356|NCT01218477|Primary|Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase|The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for >7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If <3 patients were DLT-evaluable, up to 6 additional patients entered the same dose level. Accrual to a dose level closed if 6 patients were enrolled and <3 were DLT-evaluable. If ≥3 patients at a dose level had no DLTs when a new patient enrolled, the dose was escalated to next level. If 1 DLT was observed in <6 patients, ≥6 patients were required; if no additional DLT was observed, the dose was escalated to the next highest level. If ≥2 DLTs were observed in <6 patients, that level exceeded the RP2D, and the dose was deescalated to the next lowest level.|Day 1 to Week 80, with observation for DLT in Weeks 5-8|Participants who were dose-limiting toxicity (DLT)-evaluable (DLT-evaluable=received combination therapy on >21 of 28 days in Weeks 5 through 8 or interrupted treatment for drug-related AEs)|||mg|||Number
2703357|NCT01218438|Secondary|Life Quality Index - 13 Years and Older|"For the age group 13 years and older the respondent will be the participant.~Each of the four domains has a separate score, each has a different range as follows:~Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
2703358|NCT01218438|Secondary|Life Quality Index - 2 to 12 Years Old|"For the age group 2 to 12 years the respondent will be a parent.~Each of the four domains has a separate score, each has a different range as follows:~Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
2703359|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older|"TSQM; for the age group 13 years and older the observer will be the participant.~Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.~The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
2703360|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old|"TSQM; for the age group 2 to 12 years the observer will be a parent.~Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.~The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
2703361|NCT01218438|Secondary|Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 14 years and older with scores at each respective time point.|||Scores on a scale||95% Confidence Interval|Median
2703362|NCT01218438|Secondary|Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.|||Score on a scale||95% Confidence Interval|Median
2703382|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant|Number of all SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set|||Adverse events per participant|||Number
2703383|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion|Number of related SAEs and AEs divided by number of subjects and divided by number of infusions|Up to 20 months per subject (throughout entire study)|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
2703363|NCT01218438|Secondary|Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set (subset of participants aged 2 to 7 years)|||Score on a scale||95% Confidence Interval|Median
2703364|NCT01218438|Secondary|Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration|Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.|Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40|Safety Analysis Set|||Participants|||Number
2703365|NCT01218438|Secondary|Short Term Tolerance - Change in Body Temperature||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
2703366|NCT01218438|Secondary|Short Term Tolerance - Change in Respiratory Rate||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
2703367|NCT01218438|Secondary|Short Term Tolerance - Change in Heart Rate (Pulse)||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
2703368|NCT01218438|Secondary|Short Term Tolerance - Change in Blood Pressure||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
2703369|NCT01218438|Secondary|Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration|"An infusion will be deemed as tolerated unless one of the following occurs:~Any serious related AE(s)~Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion~Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion"|Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of infusions|Infusions||Number
2703370|NCT01218438|Secondary|Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of participants|||Number
2703371|NCT01218438|Secondary|Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set|||Infusions|Infusions||Number
2703372|NCT01218438|Secondary|Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)||Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of participants|||Number
2703373|NCT01218438|Secondary|Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)|The number of infusions associated with local non-SAEs divided by the total number of infusions.|Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of infusions|Infusions||Number
2703374|NCT01218438|Secondary|Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion|"The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion (temporally associated) plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug(related), divided by the total number of infusions"|Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
2703375|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions|Within 1 hour of completion of infusion|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
2703376|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants|Within 1 hour of completion of infusion|Safety Analysis Set|||Adverse events per participant|||Number
2703377|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions|Within 24 hours of completion of infusion|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
2703378|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants|Within 24 hours of completion of infusion|Safety Analysis Set|||Adverse events per participant|||Number
2703379|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions|Within 72 hours of completion of infusion|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
2703380|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants|Within 72 hours of completion of infusion|Safety Analysis Set|||Adverse events per participant|||Number
2703381|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion|Number of all SAEs and AEs divided by number of infusions|Up to 20 months per subject (throughout entire study)||2017-08-31|08/2017||||
2703384|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant|Number of related SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set|||Adverse events per participant|||Number
2703385|NCT01218438|Secondary|Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)|"There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals.~To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured.~The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4.~This was an interim study analysis."|29 weeks|Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4|||Correction factor|||Number
2703386|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mg/L||95% Confidence Interval|Median
2703387|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||Hours (s)||95% Confidence Interval|Geometric Mean
2703388|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mg/L||95% Confidence Interval|Geometric Mean
2703389|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mL/kg/days||95% Confidence Interval|Geometric Mean
2703390|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||(mg*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
2703391|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mg*days/L||95% Confidence Interval|Geometric Mean
2703392|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||g/L||95% Confidence Interval|Geometric Mean
2703393|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||hours (h)||95% Confidence Interval|Geometric Mean
2703394|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||g/L||95% Confidence Interval|Geometric Mean
2703395|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time point|||mL/kg/days||95% Confidence Interval|Geometric Mean
2703609|NCT01217840|Secondary|High-density Lipoprotein (HDL) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||mg/dL||Standard Error|Mean
2703396|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||(g*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
2703397|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||g*days/L||95% Confidence Interval|Geometric Mean
2703398|NCT01218438|Secondary|Trough Levels of Anti-Hepatitis B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||mIU/mL||95% Confidence Interval|Geometric Mean
2703399|NCT01218438|Secondary|Trough Levels of Anti-Haemophilus Influenza B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||mg/L||95% Confidence Interval|Geometric Mean
2703400|NCT01218438|Secondary|Trough Levels of Anti-Tetanus Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||IU/mL||95% Confidence Interval|Geometric Mean
2703401|NCT01218438|Secondary|Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals||"Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||g/L||95% Confidence Interval|Geometric Mean
2703402|NCT01218438|Secondary|Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)|"IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution;~AUCSC = area under the concentration-time curve following subcutaneous administration;~AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval"|Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18|Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1|||Ratio||90% Confidence Interval|Geometric Mean
2703403|NCT01218438|Secondary|Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated visits/participant||95% Confidence Interval|Number
2703404|NCT01218438|Secondary|Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated days/participant||95% Confidence Interval|Number
2703405|NCT01218438|Secondary|Annual Rate of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated hospitalizations/participant||95% Confidence Interval|Number
2703406|NCT01218438|Secondary|Annual Rate of Days on Antibiotics Per Participant||1 year|Safety Analysis Set|||Estimated days/particpant||95% Confidence Interval|Number
2703407|NCT01218438|Secondary|Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated days off/participant||95% Confidence Interval|Number
2703408|NCT01218438|Secondary|Annual Rate of Fever Episodes Per Participant||1 year|Safety Analysis Set|||Estimated episodes/year||95% Confidence Interval|Number
2703409|NCT01218438|Secondary|Annual Rate of Sinus Infections Per Participant||1 year|Safety Analysis Set|||Estimated infections/year||99% Confidence Interval|Number
2703410|NCT01218438|Secondary|Annual Rate of All Infections Per Participant||1 year|Safety Analysis Set|||Estimated infections/year||95% Confidence Interval|Number
2703411|NCT01218438|Primary|Rate of Acute Serious Bacterial Infections Per Year (ASBI)|"Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant.~The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit."|1 year|Safety Analysis Set|||Estimated infections/ year|||Number
2703412|NCT01218399|Secondary|Adverse Events|Number of adverse events as per MEDRA terms|1 week||||Number adverse events|||Number
2703413|NCT01218399|Primary|Percent Forced Expiratory Volume in One Second (FEV1)|"Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second~FEV1 is given which is a standard outcome in asthma studies and is validated by the NIH (NHLBI)~FEV1 of less than 80 is indicative of severe asthma, 80-90 is moderate asthma, over 90 is mild asthma~http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3_pocket_guide.pdf"|1 week||||% FEV1||Standard Deviation|Mean
2703610|NCT01217840|Secondary|Triglycerides at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||mg/dL||Standard Error|Mean
2703611|NCT01217840|Primary|25OH Vitamin D|Primary outcome is serum 25OH vitamin D concentrations|Baseline; Week 24|Patients who completed the study were analyzed.|||ng/mL||Standard Error|Mean
2703414|NCT01218308|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
2703415|NCT01218308|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
2703416|NCT01218308|Secondary|Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
2703417|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
2703418|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||subjects|||Number
2703419|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||subjects|||Number
2703420|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects < 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||subjects|||Number
2703421|NCT01218308|Secondary|Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2703422|NCT01218308|Secondary|Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2703612|NCT01217827|Primary|Referral for Implantable Cardioverter Defibrillator||6 months||||participants|||Number
2703613|NCT01217814|Secondary|Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab||Week 12|Analysis was performed in PK population of all participants with at least one non-missing serum concentration data.|||ng/mL||Standard Deviation|Mean
2703423|NCT01218308|Secondary|Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2703424|NCT01218308|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|On Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2703425|NCT01218308|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||fold increase||95% Confidence Interval|Mean
2703426|NCT01218308|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||subjects|||Number
2703427|NCT01218308|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||subjects|||Number
2703428|NCT01218308|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||titers||95% Confidence Interval|Geometric Mean
2703429|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.|To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
2703430|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.|To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
2706679|NCT01195090|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||mg/dl||Standard Error|Least Squares Mean
2703431|NCT01218308|Secondary|Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.|"To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with:~Fever >39°C, and/or at least one of the following manifestations,~Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,~Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis"|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
2703432|NCT01218308|Primary|Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.|To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
2703433|NCT01218243|Primary|Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.|baseline and the 6th week|The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis.|||units on a scale||Standard Deviation|Mean
2703434|NCT01218243|Secondary|Change of International Prostate Symptom Score (IPSS) at the 18th Week|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.|baseline and the 18th week|The data analysis of the secondary outcome was based on the ITT population.|||units on a scale||Standard Deviation|Mean
2703435|NCT01218243|Secondary|Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week|Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.|||ml/second||Standard Deviation|Mean
2703436|NCT01218243|Secondary|Change of Bladder Residual Urine at the 6th Week|Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.|||ml||Full Range|Median
2703437|NCT01218243|Primary|Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.|baseline and the 6th week|The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed).|||units on a scale||Standard Deviation|Mean
2703438|NCT01218204|Secondary|Trough Concentration of Atorvastatin Metabolite (2-Hydroxyatorvastatin)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were supposed to collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were supposed to collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were supposed to collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16). However no data was collected.|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|||||||
2703439|NCT01218204|Secondary|AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703440|NCT01218204|Secondary|AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A|Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703475|NCT01218204|Primary|Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Run-in)|Assessment of vital signs including SBP, DBP and heart rate was performed on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to day 28|All subjects Population.|||Participants|||Count of Participants
2703441|NCT01218204|Secondary|Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose and on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
2703442|NCT01218204|Secondary|Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A|Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||hours||Full Range|Median
2703443|NCT01218204|Secondary|Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703444|NCT01218204|Secondary|Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A|Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703445|NCT01218204|Primary|Weighted Mean Area Under Concentration Curve From 0 to 24 Hours (AUC [0-24]) Change From Baseline for Triglycerides at Day 14|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was Day -1 value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||millimoles per liter||Geometric Coefficient of Variation|Geometric Mean
2703446|NCT01218204|Primary|Percent Change From Baseline in Lipid Metabolism: LDL/HDL Ratio at Day 14 (24 Hours)|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2703447|NCT01218204|Primary|Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours)|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2703476|NCT01218204|Primary|Number of Participants With Vital Signs of PCI- Part B (Washout)|Assessment of vital signs including SBP, DBP heart rate was performed at Screening, on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to day 28|All subjects Population.|||Participants|||Count of Participants
2703448|NCT01218204|Primary|Percent Change From Baseline in Lipid Metabolism: Apolipoprotein E at Day 14 (24 Hours)|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Perecent change||Standard Deviation|Mean
2703449|NCT01218204|Primary|Percent Change From Baseline for Lipid Metabolism: Apolipoprotein A1 and Apolipoprotein B100 at Day 14|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2703450|NCT01218204|Primary|Trough Concentration of Atorvastatin|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were planned to be collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were planned to be collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were planned to be collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was planned to be collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Data was not collected for this outcome measure.||||||
2703451|NCT01218204|Primary|AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703452|NCT01218204|Primary|AUC (0-24) of Atorvastatin- Part A|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703453|NCT01218204|Primary|Tmax of Atorvastatin- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at specified time points were analyzed.|||hours||Full Range|Median
2703454|NCT01218204|Primary|Tmax of Atorvastatin- Part A|Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||hours||Full Range|Median
2703477|NCT01218204|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A|Assessment of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate was performed after admission on Day -1 and at Follow-up. On Days 1, 7 and 14, they were taken at pre-dose, 1, 3, 6, 8, 14 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
2706680|NCT01195090|Secondary|Change in Fasting Total-cholesterol|Total-cholesterol change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
2703455|NCT01218204|Primary|Cmax of Atorvastatin- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703456|NCT01218204|Primary|Cmax of Atorvastatin- Part A|Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703457|NCT01218204|Primary|Trough Concentration of GSK1292263|Trough samples for GSK1292263 PK (all treatment arms) were planned to be collected early in the morning on Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48h PK sample was collected on Day 16). (pre-dose for Days 13 and 14; trough Day 15 = 24h post last dose; trough Day 16 = 48h post last dose).|On Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK concentration Population. Data was not collected for this outcome measure.||||||
2703458|NCT01218204|Primary|AUC(0-24) of GSK1292263- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703459|NCT01218204|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours [AUC(0-24)] of GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).|On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703460|NCT01218204|Primary|Tlag of GSK1292263- Part B (Pooled Treatment Arm)|Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.|PK parameter Population. Only those participants with data available at the indicated time points were analyzed.|||hours||Full Range|Median
2703461|NCT01218204|Primary|Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
2703462|NCT01218204|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263 on Days 1 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48h sample on Day 1).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population|||hours||Full Range|Median
2703463|NCT01218204|Primary|Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).|On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
2703478|NCT01218204|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)|Single ECGs were taken after admission on Day -2, and pre-breakfast on Days -1, 4, 10, and at Follow-up. On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. The data was found to be abnormal clinically significant in treatment phase.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
2703464|NCT01218204|Primary|Cmax of GSK1292263- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703465|NCT01218204|Primary|Maximum Observed Concentration (Cmax) of GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263 on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).|On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|Pharmacokinetic (PK) Parameter Population was defined as participants in the ‘PK Concentration’ population for whom PK parameters were derived. The ‘PK Concentration Population' was defined as participants in the ‘All Subjects’ Population for whom a PK sample was obtained and analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2703466|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm)|Samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24 hours post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Glucose, Total bilirubin, Albumin, Magnesium, CO2/HCO3, Calcium, ALT, AST, Inorganic phosphorus, Potassium and Sodium) are presented for which findings are of PCI either high or low.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
2703467|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in)|Samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Glucose, Magnesium, ALT, AST, Calcium, Inorganic phosphorus and Total bilirubin) are presented for which findings are of PCI either high or low.|Days 14 and 28|All subjects Population.|||Participants|||Count of Participants
2703468|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout)|Samples were collected at screening, and on Days1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Inorganic phosphorus, Sodium, Alanine aminotransferase [ALT], Potassium, Creatinine, Calcium, magnesium, Glucose, Total Bilirubin, Carbon dioxide/bicarbonate [CO2/HCO3] and Aspartate aminotransferase [AST]) are presented for which findings are of PCI either high or low.|Up to Day 28|All subjects Population.|||Participants|||Count of Participants
2703469|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part A|Samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). No parameter was found to have any value of PCI.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
2703470|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm)|Blood samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24hrs post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24hrs post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Platelet count, Total neutrophils and Lymphocytes) are presented for which findings are of PCI either high or low.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
2703471|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part B (Run-in)|Blood samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Lymphocytes) are presented for which findings are of PCI either high or low.|Days 14 and 28|All subjects Population.|||Participants|||Count of Participants
2703472|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout)|Blood samples were collected at screening, and on Days 1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (White blood cells [WBC], Total neutrophils, Hematocrit and Lymphocytes) are presented for which findings are of PCI either high or low.|Up to Day 28|All subjects Population.|||Participants|||Count of Participants
2703473|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part A|Blood samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Data for only those parameters (Hematocrit, Hemoglobin and Total neutrophils) are presented for which findings are of PCI either high or low.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
2703474|NCT01218204|Primary|Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm)|Assessment of vital signs including SBP, DBP and heart rate was performed after admission on Day-2, and pre-breakfast on Days -1, 4, and 10 in a fasting state early in the morning (prior to dosing), and at Follow-up. On Days 1, 7 and 14, they were also be taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
2706681|NCT01195090|Secondary|Percentages of Patients With Total Adverse Events (AE)|percentages of total adverse events|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
2703479|NCT01218204|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)|ECGs were taken on Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No data found to be abnormal clinically significant in run-in phase.|Day 28|All subjects Population. Only those participants present during Run in/Day 28 were evaluated/included.|||Participants|||Count of Participants
2703480|NCT01218204|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout)|ECGs were taken at Screening, and on Day1 and Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings.|Up to Day 28|All subject Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2703481|NCT01218204|Primary|Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A|Single ECGs were taken after admission on Day -1 and at Follow-up (up to Day 26). On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No value found to be abnormal clinically significant in Part A of the study.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
2703482|NCT01218204|Primary|Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 26|All subject Population|||Participants|||Count of Participants
2703483|NCT01218204|Primary|Number of Participants With Any AEs and SAEs- Part B (Run-in)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 28|All subject Population|||Participants|||Count of Participants
2703484|NCT01218204|Primary|Number of Participants With Any AEs and SAEs- Part B (Washout)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 28|All subject Population consisted of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2703485|NCT01218204|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 26|Safety Population consisted of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2703486|NCT01218126|Secondary|Total Number of Exacerbations Over 24 Weeks|An exacerbation of COPD is defined as a worsening of COPD symptoms requiring changes to normal treatment (other than increased use of relief salbutamol/albuterol) including antimicrobial therapy, short courses of oral steroids, other bronchodilator therapy and/or emergency treatment or hospitalization.|Up to 24 weeks|ITT population.|||Number of exacerbations|||Number
2703487|NCT01218126|Secondary|Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks|Least square mean ratio to Baseline of HsCRP was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.|Baseline (Week 0) and Week 4, 8, 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Error|Geometric Mean
2703488|NCT01218126|Secondary|Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks|Least square mean ratio to Baseline of plasma fibrinogen was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.|Baseline (Week 0) and Week 4, 8, 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Error|Geometric Mean
2706682|NCT01195090|Secondary|Body Weight Change|body weight change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||kg||Standard Error|Least Squares Mean
2703489|NCT01218126|Secondary|Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24|A plethysmograph is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains). Plethysmography was used to assess IC, RV, TGV at FRC, SLV, and TLC. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).|Baseline(Week 0) and Week 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||mL||Standard Error|Least Squares Mean
2703490|NCT01218126|Secondary|Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24|The SGRQ-C questionnaire had 14 questions of COPD and participant had to rate each question. These 14 questions were separated to evaluate the three components of SGRQ-C. These three components were symptom component (question 1 to 7), activity component (question 9 and 12) and impact component (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Change from Baseline was calculated as the specified time point value minus the Baseline value. Baseline visit was Visit 2 (Week 0).|Baseline (Week 0) and Week 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2703491|NCT01218126|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24|FVC is the total amount of air exhaled during the lung function test. and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.. Baseline visit was Visit 2 (Week 0).|Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||mL||Standard Error|Least Squares Mean
2703492|NCT01218126|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Pre and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.Baseline visit was Visit 2 (Week 0).|Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Millilitre(mL)||Standard Error|Least Squares Mean
2703493|NCT01218126|Primary|Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24|Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the second six-minute walk test (6MWD2) being compared was defined as: Variability = [100 x (6MWD2 - 6MWD1)]/6MWD1. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).|Baseline (Week 0) and Week 4, 12, 24|Intent-to-treat (ITT) population consisted of all participants randomized to treatment and who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.|||Meter (m)||Standard Error|Least Squares Mean
2703494|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-F4co Antibodies|Seropositivity rates for antibodies against F4co antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 42 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2703495|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-RT Antibodies|Seropositivity rates for antibodies against RT antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 125 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2703496|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-Nef Antibodies|Seropositivity rates for antibodies against Nef antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 494 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2703614|NCT01217814|Secondary|Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2703497|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-P24 Antibodies|Seropositivity rates for antibodies against P24 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 119 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2703498|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-P17 Antibodies|Seropositivity rates for antibodies against P17 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 187 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2703499|NCT01218113|Secondary|Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||RT-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
2703500|NCT01218113|Secondary|Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of P24-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P24-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
2703501|NCT01218113|Secondary|Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of P17-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P17-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
2703502|NCT01218113|Secondary|Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of Nef-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Nef-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
2703503|NCT01218113|Secondary|Cytokine Expression Profile of F4co-Computed CD8+ T Cells|The cytokine co-expression profile was defined by the frequency of F4co-Computed CD8+ T-cells [Frequency of CD8+ T cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||F4co-Computed CD8+ T-cells/million cells||Inter-Quartile Range|Median
2703504|NCT01218113|Secondary|Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||RT-specific CD4+ T-cells/million cells||Inter-Quartile Range|Median
2703505|NCT01218113|Secondary|Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of P24-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P24-specific CD4+ T-cells/million cells||Inter-Quartile Range|Median
2703615|NCT01217814|Secondary|European League Against Rheumatism (EULAR) Response at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2703506|NCT01218113|Secondary|Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of P17-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P17-specific CD4+ T-cells/million T-cell||Inter-Quartile Range|Median
2703507|NCT01218113|Secondary|Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of Nef-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Nef-specific CD4+ T-cells/million cells||Inter-Quartile Range|Median
2703508|NCT01218113|Secondary|Cytokine Expression Profile of F4co-Computed CD4+ T Cells|The cytokine co-expression profile was defined by the frequency of F4co-Computed CD4+ T-cells [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||F4co-computed CD4+ T-cells/million cells||Inter-Quartile Range|Median
2703509|NCT01218113|Secondary|Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens|Breadth was assessed only for the CD4+ T-cells and was measured by evaluating response to at least 1, 2, 3 or all 4 antigens: proteins 17, 24, Nef, reverse transcriptase (RT).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2703510|NCT01218113|Secondary|Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD8+ T-cells and F4co-Computed [frequency of CD8+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD8+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2703511|NCT01218113|Secondary|Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2703512|NCT01218113|Secondary|Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L-CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L-CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD40L-CD4+ T-cells/million T-cells||Inter-Quartile Range|Median
2703541|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) period following Dose 3|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2703513|NCT01218113|Secondary|Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD40L+CD4+ T-cells/million T-cells||Inter-Quartile Range|Median
2703514|NCT01218113|Secondary|Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) - specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD40L+CD+ T-cells/million cells||Inter-Quartile Range|Median
2703515|NCT01218113|Secondary|Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events|"Only actual ART initiations were reported under the category ART initiation. HIV-related clinical events were defined as: clinical disease progression, or confirmed VL > 100.000 copies/mL, or confirmed CD4 cell count < 350 cells/ cubic millimeter (mm3)."|During the entire study period (up to Week 48)|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||Percentage of participants|||Number
2703516|NCT01218113|Secondary|Mean Change in CD4 Cell Count From Baseline|Baseline for CD4 cell count analysis was defined as the mean of values measured in blood taken at Screening and at pre vaccination (PRE). Result determination, using crude values, was done from week 1 to 28 for the HIV Group, weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from week 1 to week 48 for the Control Group.|At Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||CD4 cells/cubic millimeter||Standard Deviation|Mean
2703517|NCT01218113|Secondary|Cluster of Differentiation 4 (CD4) Absolute Cell Count|Result determination, using crude values, was done from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening (SCR) to Week (W) 48 for the Control Group.|At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||CD4 cells/cubic millimeter||Standard Deviation|Mean
2703518|NCT01218113|Secondary|Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1|The proportion of subjects with >1 decrease of HIV-1 VL, was determined using log10-transformed values.|At Week 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||Percentage of participants|||Number
2703519|NCT01218113|Secondary|Levels of HIV-1 VL|HIV-1 VL, using log10 transformed values, was expressed in log10-RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.|At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||log10 (RNA Copies/mL)||Inter-Quartile Range|Median
2703520|NCT01218113|Secondary|Levels of HIV-1 Viral Load (VL)|HIV-1 VL, using crude values, was expressed in RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.|At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||RNA Copies/mL||Inter-Quartile Range|Median
2703521|NCT01218113|Secondary|Geometric Mean Change in HIV-1 VL From Baseline|Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 29 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.|At Weeks 1, 4, 6, 16, 28, 30 and 38|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||log10(RNA copies/mL)||Standard Deviation|Geometric Mean
2703616|NCT01217814|Secondary|Disease Activity Score for 28 Joints (DAS28) at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2703522|NCT01218113|Secondary|Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline|Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.|At Weeks 1, 4, 6, 16, 28, 30 and 38|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||RNA copies/mL||Standard Deviation|Geometric Mean
2703523|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 48|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2703524|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 38|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2703525|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 30|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2703526|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 28|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
2703527|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 16|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
2703557|NCT01218048|Primary|Serum Cytokines Levels|Serum cytokines levels measured at pre-/post-cetuximab, exposure measured in picogram per milliliter of plasma (pg/ml)|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)|Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.|||pg/ml||Inter-Quartile Range|Median
2703617|NCT01217814|Secondary|Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2703528|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 6|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
2703529|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 4|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
2703530|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|Pre-vaccination, at Week 0|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.|||Participants|||Count of Participants
2703531|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Screening|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since the screening timepoint was identical for both groups.|||Participants|||Count of Participants
2703532|NCT01218113|Primary|Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs)|Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (up to Week 48)|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2703533|NCT01218113|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Week 48)|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2703534|NCT01218113|Primary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 3 and across doses.|During the 28-Day (Days 0-27) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2703602|NCT01217892|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||Percent||Standard Error|Least Squares Mean
2703535|NCT01218113|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.|During the 28-Day (Days 0-27) period following Dose 1 and Dose 2|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
2703536|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2703537|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) period following Dose 3|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2703538|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) period following Dose 2|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.|||Participants|||Count of Participants
2703539|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) period following Dose 1|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.|||Participants|||Count of Participants
2703540|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2703542|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) period following Dose 2|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.|||Participants|||Count of Participants
2703543|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) period following Dose 1|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.|||Participants|||Count of Participants
2703544|NCT01218113|Primary|Geometric Mean Change in HIV-1 VL From Baseline|Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.|At Week 48, post-Dose 3|The analysis was performed on the Modified Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||log10(RNA copies/mL)||Standard Deviation|Geometric Mean
2703545|NCT01218113|Primary|Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline|Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter [copies/mL]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.|At Week 48, post-Dose 3|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||RNA copies/mL||Standard Deviation|Geometric Mean
2703546|NCT01218100|Secondary|The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)||||mm HG||Standard Deviation|Mean
2703547|NCT01218100|Primary|The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)||||mm HG||Standard Deviation|Mean
2703548|NCT01218087|Secondary|Incidence of Cardiorespiratory|daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside|daily up to 120 days||||cardioresp. events/100hrs of device use|||Number
2703549|NCT01218087|Primary|Cranial Abnormalities Were Measured at Hospital Discharge|Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.|up to 120 days||||% participant cranial abnormalities|||Number
2703550|NCT01218048|Secondary|Change in Tumor Size|Largest percent change (decrease) in tumor size before and after neoadjuvant cetuximab.|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)||||percent|||Number
2703551|NCT01218048|Secondary|3-year Progression-free Survival (PFS)|Percentage of participants alive at 3 years that did not experience disease progression per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.|3 years||||percentage of participants||95% Confidence Interval|Number
2703552|NCT01218048|Secondary|Objective Response (Rate)|The percentage of participants that experienced a response to study treatment, per RECIST 1.0: Number of participant with (Complete Response (CR) + number of participants with Partial Response (PR) / Total number of participants evaluable for response.|Up to 2 years|Participant that where evaluable for response to treatment with cetuximab (400 mg/m2 then 250mg/m2/week) for 3-4 weeks preoperatively, followed by adjuvant chemoradiation with or without cetuximab.|||percentage of participants|||Number
2703553|NCT01218048|Secondary|Overall Survival (OS)|Number of patients remaining alive.|Up to 2 years|All patients enrolled in the study.|||participants|||Number
2703554|NCT01218048|Secondary|Progression-free Survival (PFS)|The length of time during and after study treatment that participants lived with disease that did not progress per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.|Up to 54 months||||months||Full Range|Median
2703555|NCT01218048|Secondary|Frequency of EGFR-specific T Cells (EGFR853-861 Peptide-specific Tetramer+ CD8+T Cells)|Difference in frequency of circulating EGFR-specific T cells between cetuximab-treated and cetuximab-naive patients|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)||||EGFR+ T cells/10^4 T cells||Full Range|Mean
2703556|NCT01218048|Primary|T Cell Activation|T cell activation measured at pre-/post-cetuximab exposure|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)|Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.|||percentage of T cell activation||Inter-Quartile Range|Median
2703558|NCT01218048|Primary|NK Cell Activation|Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)|Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.Patients defined as responders, demonstrated upregulation of CD137 on tumor infiltrating NK cells following cetuximab therapy compared with non-responders.|||percentage of activity||Inter-Quartile Range|Median
2703559|NCT01218009|Post-Hoc|Pulse at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population|||beats/minute||Standard Deviation|Mean
2703560|NCT01218009|Post-Hoc|Blood Pressure at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population|||mmHg||Standard Deviation|Mean
2703561|NCT01218009|Primary|Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator|Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
2703562|NCT01218009|Primary|Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator|A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
2703563|NCT01218009|Primary|Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator|Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
2703564|NCT01218009|Primary|Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator|A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
2703565|NCT01218009|Primary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 49 (study termination)|Safety population|||participants|||Number
2703566|NCT01217957|Secondary|Phase 2: 1 Year Survival Rate|1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.|1 year after first dose of study drug||||percentage of participants||95% Confidence Interval|Number
2703567|NCT01217957|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.|Up to 787 days|The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.|||months||95% Confidence Interval|Median
2703568|NCT01217957|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.|||months||95% Confidence Interval|Median
2703569|NCT01217957|Secondary|Phase 2: Time to Best Response|Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.|Up to 787 days|Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.|||months||Full Range|Median
2703570|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.|Cycles 3, 6, 9 and 12 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2703571|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|After Cycles 3, 6 and 9 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2703572|NCT01217957|Secondary|Phase 2: Overall Response Rate (ORR)|ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2703573|NCT01217957|Secondary|Phase 2: Overall Survival (OS)|OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.|From the first dose of study treatment to the date of death (up to 787 days)|Safety Population included al participants who received 1 of the 3 study drugs. Participants who did not die were censored at the last study visit.|||participants||95% Confidence Interval|Median
2703574|NCT01217957|Secondary|Phase 2: Time to Progression (TTP)|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).|From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)|The modified Intent-to-Treat (mITT) population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.|||months||95% Confidence Interval|Median
2703575|NCT01217957|Secondary|Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome|TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose|||||||
2703576|NCT01217957|Secondary|Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome|Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose|||||||
2703577|NCT01217957|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.|Cycle 1, Day 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.|||Ratio||Standard Deviation|Geometric Mean
2703578|NCT01217957|Secondary|Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.|||hr*ng/mL||Standard Deviation|Geometric Mean
2703579|NCT01217957|Secondary|Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with data available.|||hours||Full Range|Median
2703603|NCT01217840|Secondary|Adiponectin at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
2703580|NCT01217957|Secondary|Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib|Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.|||ng/mL||Standard Deviation|Geometric Mean
2703581|NCT01217957|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.|||percentage of participants|||Number
2703582|NCT01217957|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone|MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.|||mg/m^2|||Number
2703583|NCT01217957|Primary|Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone|RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.|||mg/m^2|||Number
2703584|NCT01217957|Primary|Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone|ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or; 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|Participants from the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.|||percentage of participants||95% Confidence Interval|Number
2703585|NCT01217957|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.|||participants|||Number
2703586|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period|Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.|Month 3 up to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment.|||injections||Standard Deviation|Mean
2703587|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period|Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period|Day 1 prior to month 6 and prior to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment|||injections||Standard Deviation|Mean
2703588|NCT01217944|Secondary|Number of Ranibizumab Injections Received Prior to Month 3|In order to describe exposure to the study drug the number of ejections was evaluated|Day 1 and prior to month 3|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment|||injections||Standard Deviation|Mean
2703589|NCT01217944|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye|CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.|Baseline and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
2703590|NCT01217944|Secondary|Change From Baseline in Central Retinal Thickness of the Study Eye Over Time|Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.|Baseline, Month 3, Month 6 and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Microns||Standard Deviation|Mean
2703591|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
2703592|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
2703593|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
2703594|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
2703595|NCT01217944|Secondary|Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12|Baseline and Month 1 through Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Letters||Standard Deviation|Mean
2703596|NCT01217944|Secondary|Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.|Baseline and Month 6|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Letters||Standard Deviation|Mean
2703597|NCT01217944|Primary|Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.|Baseline, Month 1 through Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Letters||Standard Deviation|Mean
2703598|NCT01217892|Secondary|Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.|To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2703599|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||mg/dL||Standard Error|Least Squares Mean
2703600|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.|Baseline to Week 1|Full Analysis Set, participants with non-missing baseline and Week 1 values|||mg/dL||Standard Error|Least Squares Mean
2703601|NCT01217892|Secondary|Adjusted Percent Change in Body Weight|To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||Percent||Standard Error|Least Squares Mean
2703618|NCT01217814|Secondary|Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2703619|NCT01217814|Primary|Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2703620|NCT01217801|Primary|Area Under Plasma Concentration|Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.|Day 1 and Day 7|All that completed a period|||ng*hr/ml||Standard Deviation|Mean
2703621|NCT01217749|Primary|Safety During Dose-Limiting Toxicity (DLT) Observation Period|Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2|56 days for Group 1 and 28 days for Group 2||||participants who experienced DLT|||Number
2703622|NCT01217749|Secondary|Progression Free Survival (PFS) at 12 Months|"Progressive disease for CLL (Hallek) is characterized by ≥1 of the following:~Appearance of any new lesion, eg lymph nodes (> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates~Increase of ≥50%~in longest diameter of any previous site~in hepatomegaly or splenomegaly~in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen~Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir:~Appearance of a new lesion(s) >1.5 cm in any axis, ≥ 50% increase in the SPD of >1 node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis~Lesions PET+ if FDG-avid lymphoma or PET+ before therapy~50% increase from nadir in the SPD of any liver or spleen lesions~New or recurrent BM involvement~Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen"|From first dose of study treatment until disease progression, death, or until 12 months||||percentage of event free participants||95% Confidence Interval|Mean
2703623|NCT01217749|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of study treatment to within 30 days of last dose or until study closure||||participants|||Number
2703624|NCT01217749|Primary|Percentage of Participants Achieving Response|The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.|The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months||||percentage of participants||95% Confidence Interval|Number
2703625|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by ANCOVA.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2703626|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by a mixed-effect model for repeated measure.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation and who have data at the noted time point (no missing imputation)|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2703627|NCT01217606|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test.|Baseline, Week 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2703628|NCT01217515|Secondary|Assessment of Adverse Events, Clinical Laboratory Results, Vital Signs and Sensitivity Reactions|Number of subjects with adverse events, abnormal clinical laboratory results, vital signs and occurrence of any local sensitivity reactions. Data are presented where the incidence is greater than or equal to 5%.|8 weeks||||percentage of participants|||Number
2703629|NCT01217515|Secondary|Patient's Global Impression of Improvement (PGI-I)|"Compared to the way you felt prior to starting the study treatment, how would you now describe your problems related to the anal fissure? Responses will be measured on a 7-point Likert scale where 1 = substantially worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = substantially improved. Percentage of subjects scoring 5,6 or 7 was assessed."|4 weeks||||percentage of participants|||Number
2703645|NCT01217307|Secondary|Cardiac MRI After 4 Months, Per Protocol Analysis|A per-protocol analysis, excluding patients diagnosed with new onset diabetes and treated with oral antihyperglycemic agents or insulin prior to cardiac MRI, will be performed as a secondary efficacy parameter|4 months|||||||
2703630|NCT01217515|Primary|Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation for Week 4 (for the 7 Treatment Days Immediately Preceding the Week 4 Visit).|Change from baseline in average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable.|4 weeks||||units on a scale||Standard Error|Mean
2703631|NCT01217476|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
2703632|NCT01217476|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Origin After a Maximum of 12 Weeks Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition to Best Local Cares|wound closure is defined as 100% reepithelialization of the target DFU, without exudates.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
2703633|NCT01217463|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
2703634|NCT01217463|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition|Wound closure is defined as 100% reepithelialization of the target DFU, without exudate.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
2703635|NCT01217437|Secondary|Event-free Survival|Percentage Probability of remaining event-free 5 years after enrollment estimated by the method of Kaplan and Meier|Up to 5 years after enrollment|Randomized eligible patients. 2 patients were excluded due to ineligibility.|||percent probability||95% Confidence Interval|Number
2703636|NCT01217437|Secondary|Response|Patient's best response during protocol therapy coded as complete response, partial response or no response.|Up to 12 cycles of therapy (11 months)|Eligible patients who were enrolled and had measurable disease according to the protocol definition at the time of enrollment.|||Participants|||Count of Participants
2703637|NCT01217437|Primary|Overall Survival|Percentage Probability of remaining alive 5 years after enrollment estimated by the method of Kaplan and Meier|Up to 5 years after enrollment|Randomized eligible patients. 2 patients were excluded due to ineligibility.|||percent probability||95% Confidence Interval|Number
2703638|NCT01217411|Primary|Response Rate (Complete or Partial Response)|Only participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): >25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or > new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions.|12 weeks||||Participants|||Count of Participants
2703639|NCT01217411|Primary|Phase 1 Arm II MTD of RO4929097 in Combination With Stereotactic Surgery (SRS)|MTD of RO4929097 in combination with SRS, determined according to incidence of DLT graded using the NCI CTCAE version 4.0 (phase I)|4 weeks|Analysis was not available due to small number of patients on the study.||||||
2703640|NCT01217411|Primary|Phase 1 Arm I Maximum-tolerated Dose (MTD) of RO4929097 in Combination With Whole-brain Radiotherapy (WBRT)|Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks|Analysis was not available due to small number of patients on the study.||||||
2703641|NCT01217385|Secondary|Estimate the Optimal Cutpoint for %Change in TOI From Baseline to Mid-therapy to Predict pCR|Determine the optimal cutpoint for %Change in TOI ratio (T/N) to maximize sensitivity and specificity in the predication of pCR , as calculated by maximizing the Youden-index.|baseline to mid-therapy|participants having TOI ratio (T/N) using tumor breast normal at baseline and mid-therapy and have pathologic response data.|||percentage change in TOI|||Number
2703642|NCT01217385|Secondary|Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Oxygen Saturation (St02)|"subset analysis, subjects were stratified using the median tumor StO2~%change TOI Between Baseline and Mid-therapy dichotomized at −40% stratified by the set evaluable subjects with baseline tumor StO2 dichotomized at 76.9%. (i.e. population median).~Accuracy will be determined using ROC analysis to determine the ROC Area Under the Curve (AUC)."|baseline to mid-therapy|evaluable subjects with baseline tumor StO2 dichotomized at 76.9%. (i.e. population median) and %change TOI dichotomized at −40%|||probability||95% Confidence Interval|Number
2703643|NCT01217385|Secondary|%Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Progesterone Receptor (PR) Status (Positive, Negative, Unknown )|"Pathologic Complete response vs Non-Complete response, by PR status Progesterone Receptor Status (positive, negative, unknown ) is determined at pathological assessment of the tumor sample.~%change in TOI is evaluated from baseline to mid-therapy."|baseline to mid-therapy|Analysis population consists of the 34 participants with both baseline and mid-therapy TOI measurements.|||percentage change||Standard Deviation|Mean
2703644|NCT01217385|Primary|Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)|This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).|From baseline to mid-therapy|Bedside DOSI images of the tissue concentrations of TOI (ctHHb x tH2O/lipid) acquired on both breasts at baseline and mid-therapy during neoadjuvant chemotherapy (NAC) treatment.|||probability||95% Confidence Interval|Number
2703648|NCT01217307|Secondary|Myocardial Infarct Size and Transmural Extent of Infarction as Measured With Cardiac Magnetic Resonance Imaging|myocardial infarct size and transmural extent of infarction will be measured using Late Gadolinium Enhancement cardiac magnetic imaging|4 months after hospitalization|||||||
2703649|NCT01217307|Secondary|Markers of Heart Failure and Glycometabolic State|markers of heart failure: neurohormones (e.g. NT-proBNP), renal function (e.g. MDRD); glycometabolic state: e.g. HbA1c.|4 months and longterm follow-up|||||||
2703650|NCT01217307|Secondary|the Incidence of a Cardiovascular Event|Cardiovascular events include major cardiac adverse events (MACE; death, recurrent MI, target lesion revascularization), stroke, non-elective hospitalizations for chest pain or heart failure, all recurrent coronary interventions, and internal cardiac defibrillator implantations. Mortality will be divided into cardiac and non-cardiac. Cardiac death will be divided into three categories: heart failure, sudden death and other. A cardiologist will confirm deaths from cardiovascular causes by examining medical records obtained from hospitals and attending physicians or from attending general practitioner if the patient died at home.|4 months and longterm follow-up|||||||
2703651|NCT01217307|Primary|Improvement in Left Ventricular Ejection Fraction|The primary efficacy parameter of the GIPS-III trial is LVEF measured by cardiac MRI 4 months after randomization, based on an intention-to-treat analysis. It is hypothesized that metformin therapy will result in a higher ejection fraction after 4 months.|4 months|patients undergoing primary percutaneous coronary intervention (PCI) for STEMI|||% of LVEF||95% Confidence Interval|Mean
2703652|NCT01217229|Primary|Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)|Grade 2 adverse events were defined as events that were moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).|Baseline to 1 year postdose|Adverse events were assessed in the Safety Analysis population.|||Participants|||Count of Participants
2703653|NCT01217229|Primary|Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)||Baseline to 1 year post-dose|Adverse events were assessed in the Safety Analysis population.|||Participants|||Count of Participants
2703654|NCT01217229|Primary|Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)|Subjects were monitored for response and disease progression with contrast Computed tomography (CT) /18Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria was reported via descriptive statistics. Target tumor response is Complete Response (CR) + Partial Response (PR) and target tumor disease control rate (CR + PR + Stable Disease (SD)) are reported. Per Cheson Criteria, CR is disappearance of all evidence of disease; Partial Response is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.|Baseline to 1 year postdose|Tumor response was assessed in the Modified Intent-to-Treat population.|||Participants|||Count of Participants
2703655|NCT01217229|Primary|Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)|Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first).|Baseline to 1 year postdose|Progression-free survival was assessed in the Modified Intent-to-Treat population.|||days||Inter-Quartile Range|Median
2703656|NCT01217112|Secondary|The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment|The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.|Baseline (Day 1) and the End of Treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2703657|NCT01217112|Secondary|Adverse Events as a Measure of Patient Safety|The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.|Day 1 - Day 92|All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received.|||participants|||Number
2703658|NCT01217112|Secondary|The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment|Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2703659|NCT01217112|Secondary|The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment|Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent liver fat||Standard Deviation|Mean
2707486|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|16 weeks after enrollment||||participants|||Number
2703660|NCT01217112|Secondary|The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment|Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703661|NCT01217112|Secondary|The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment|Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703662|NCT01217112|Secondary|The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment|Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703663|NCT01217112|Secondary|The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment|Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703664|NCT01217112|Secondary|The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703665|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703666|NCT01217112|Secondary|The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703667|NCT01217112|Secondary|The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703668|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703669|NCT01217112|Secondary|The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment|Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
2703670|NCT01217112|Secondary|The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment|Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||cm||Standard Deviation|Mean
2703671|NCT01217112|Secondary|The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment|Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||cm||Standard Deviation|Mean
2707487|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|10 weeks after enrollment||||participants|||Number
2703672|NCT01217112|Secondary|The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment|Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||kg||Standard Deviation|Mean
2703673|NCT01217112|Secondary|The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment|Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
2703674|NCT01217112|Secondary|The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment|Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||kg/m^2||Standard Deviation|Mean
2703675|NCT01217112|Secondary|The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent beta function||Standard Deviation|Mean
2703676|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent sensitivity||Standard Deviation|Mean
2703677|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||IR score||Standard Deviation|Mean
2703678|NCT01217112|Secondary|The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||nmol/l||Standard Deviation|Mean
2703679|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||pmol/l||Standard Deviation|Mean
2703680|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)|At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||pmol/l||Standard Deviation|Mean
2703681|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])|A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703739|NCT01216631|Primary|Ultrasound Synovitis Score|reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment|8 weeks|Only one patient was recruited for this study due to problems with recruitment. Therefore outcome measure data is not analysed as only one patient was recruited.||||||
2703682|NCT01217112|Secondary|The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent||Standard Deviation|Mean
2703683|NCT01217112|Secondary|The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||umol/l||Standard Deviation|Mean
2703684|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703685|NCT01217112|Secondary|The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703686|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment|A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
2703687|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||umol/l||Standard Deviation|Mean
2703688|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||umol/l||Standard Deviation|Mean
2703689|NCT01217112|Secondary|The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703690|NCT01217112|Secondary|The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703691|NCT01217112|Secondary|The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703692|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
2703693|NCT01217112|Secondary|The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
2703740|NCT01216410|Secondary|Maternal Hemodynamics|The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively|Intraoperatively||||participants with SBP< 20 % baseline|||Number
2703694|NCT01217112|Secondary|The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703695|NCT01217112|Secondary|The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703696|NCT01217112|Secondary|The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703697|NCT01217112|Secondary|The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703698|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703699|NCT01217112|Primary|The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
2703700|NCT01217073|Secondary|Change From Baseline in FPG Levels at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2703701|NCT01217073|Secondary|Mean FPG Level at Baseline of the Extension Period|Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available FPG baseline data.|||mg/dL||Standard Deviation|Mean
2703702|NCT01217073|Secondary|Change From Baseline in 2h-PMG at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2703703|NCT01217073|Secondary|Mean 2h-PMG Level at Baseline of the Extension Period|Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available 2h-PMG baseline data.|||mg/dL||Standard Deviation|Mean
2703704|NCT01217073|Secondary|Change From Baseline in Plasma A1C Levels at Week 78|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
2703705|NCT01217073|Secondary|Mean Plasma A1C Level at Baseline of the Extension Period|A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available A1C baseline data.|||Percent||Standard Deviation|Mean
2703706|NCT01217073|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2703707|NCT01217073|Secondary|Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2703708|NCT01217073|Primary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 66 weeks (Weeks 12 to 78)|Analysis population defined as all randomized participants who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.|||Percentage of participants|||Number
2703709|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)|Analysis population defined as all randomized participamts who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.|||Percentage of participants|||Number
2703710|NCT01217073|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 12 weeks|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.|||Percentage of participants|||Number
2703711|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 16 weeks (including 28 days following the last dose of study drug)|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.|||Percentage of participants|||Number
2703712|NCT01217073|Primary|Change From Baseline in Plasma A1C Levels at Week 12|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
2703713|NCT01216943|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2703714|NCT01216761|Primary|Blood Culture Contamination|A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.|5 days|Intention to treat analyses. Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.|||blood culture sets|Blood culture sets||Number
2703715|NCT01216748|Secondary|Exhaled Breath Condensate (EBC) pH Variation|"EBC samples were collected at each respiratory maneuver by directing the subject's exhaled breath into a pre-cooled (-10C) tube for 10 min.~pH was measured immediately after collection."|10 minutes after each respiratory manouver.||||pH||Standard Error|Mean
2703716|NCT01216748|Primary|Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline|Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.|15 minutes after albuterol inhalation||||changes from baseline in μl.min-1.ml-1||Standard Error|Mean
2703717|NCT01216735|Secondary|Flow-mediated Brachial Vasodilation (FMD% Peak Delta)|Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation|3 weeks of treatment||||% change||Standard Error|Mean
2703718|NCT01216735|Primary|Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo|Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).|3 weeks treatment period of ICS or placebo||||% change||Standard Error|Mean
2703719|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|26 weeks|||||||
2703748|NCT01216397|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
2703749|NCT01216397|Secondary|Metformin: Vz/F|Geometric mean of Vz/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||Liter||Geometric Coefficient of Variation|Geometric Mean
2703750|NCT01216397|Secondary|Metformin: CL/F|Geometric mean of CL/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2703751|NCT01216397|Secondary|Metformin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of MRTpo of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
2703752|NCT01216397|Secondary|Metformin: t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of t1/2 of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
2703753|NCT01216397|Secondary|Metformin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of λz of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2703754|NCT01216397|Secondary|Metformin: Tmax|Median of tmax of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Full Range|Median
2703755|NCT01216397|Secondary|Metformin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of the percentage of AUCtz-infinity of Metformin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||percentage||Geometric Coefficient of Variation|Geometric Mean
2703756|NCT01216397|Secondary|Metformin: AUC0-infinity|Geometric Mean of AUC0-infinity of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2703757|NCT01216397|Primary|Metformin: AUC0-tz|Geometric Mean of AUC0-tz of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2703758|NCT01216397|Primary|Metformin: Cmax|Geometric Mean of Cmax of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2703759|NCT01216397|Secondary|Linagliptin: Apparent Volume of Distribution During the Terminal Phase Following an Extravascular Dose (Vz/F)|Geometric mean of the Vz/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||Liter||Geometric Coefficient of Variation|Geometric Mean
2703760|NCT01216397|Secondary|Linagliptin: Apparent Clearance of the Analyte in Plasma After Extravascular Administration (CL/F)|Geometric mean of the CL/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2703761|NCT01216397|Secondary|Linagliptin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of the MRTpo of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
2703762|NCT01216397|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of the t1/2 of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
2703763|NCT01216397|Secondary|Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of the λ_z of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2703764|NCT01216397|Secondary|Linagliptin: Time to Maximum Measured Concentration of the Analyte in Plasma (Tmax)|Median of the t_max of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Full Range|Median
2703765|NCT01216397|Secondary|Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of percentage of AUCtz-∞ of linagliptin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||percentage||Geometric Coefficient of Variation|Geometric Mean
2703766|NCT01216397|Secondary|Linagliptin: AUC0-infinity|Geometric mean of AUC0-infinity of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
2703767|NCT01216397|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)|Geometric mean of AUC0-72 of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
2703768|NCT01216397|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|Geometric mean of Cmax of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2703769|NCT01216332|Secondary|Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants|Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)|About 6 months after last dose of vaccine.|Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data|||Titers||95% Confidence Interval|Geometric Mean
2703770|NCT01216332|Secondary|Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants|Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)|baseline|Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data|||Titers||95% Confidence Interval|Geometric Mean
2703771|NCT01216332|Secondary|Immunogenicity: Number of Participants With a Post-titer ≥1:40|Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)|About 6 months after last dose of vaccine.|Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data|||Participants|||Count of Participants
2703772|NCT01216332|Secondary|Immunogenicity:Number of Participants With a Pre-titer ≥1:40|Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)|About 6 months after last dose of vaccine.|Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data|||Participants|||Count of Participants
2703773|NCT01216332|Secondary|Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise|Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)|About 6 months after last dose of vaccine.|Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data|||Participants|||Count of Participants
2703774|NCT01216332|Primary|Systemic Reaction|Number of participants with systemic reactions after each vaccination|From baseline to 7 days after each vaccination||||Participants|||Count of Participants
2703775|NCT01216332|Primary|Local Reactions After Each Vaccination|Number of participants with local reactions after each vaccination|From baseline to 7 days after each vaccination||||Participants|||Count of Participants
2703776|NCT01216319|Secondary|Rate of Patient Satisfaction|Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.|12 months||||percentage of patients|||Number
2703777|NCT01216319|Primary|Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)||12 months|There were two patients (three nipples) without plastic surgery matrix in place at 12MO.|||percentage of projection vs baseline|Participants|Standard Deviation|Mean
2703778|NCT01216241|Primary|Percentage of Afebrile Neutropenic Subjects|To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.|5 days||||participants|||Number
2703779|NCT01216176|Secondary|Phase II - Cohort B: Treatment Emergent Adverse Events Associated With AZD0530 (Saracatinib) Given With Anastrozole and of Anastrozole Given With Placebo|Cinically significant AEs defined as clinically significant changes in the patient's symptoms, physical examination and clinical laboratory results are reported as toxicity for AZD0530 (saracatinib) given with anastrozole and for anastrozole given with placebo|From day 1 of treatment until a maximum of 6 months of treatment||||Participants|||Count of Participants
2703780|NCT01216176|Secondary|Phase II - Cohort B: To Report the Pharmacokinetics (Mean Blood Levels of Drug) of AZD0530 (Saracatinib) and Anastrozole|Blood draws at protocol-specified timepoints to determine mean blood levels of drug for each of AZD0530 and Anastrozole.|Day 28, 56, 84|PK assays of AZD0530 could not be completed for all participants due to technical problems with the assay protocol|||ng/ml||Standard Deviation|Mean
2703781|NCT01216176|Secondary|Phase II - Cohort B: The Number of Participants Achieving Clinical Benefit Defined as Complete Response (CR), or Partial Response (PR) or Stable Disease (SD)|Based on physician measurement of tumor size and by MRI measurements of tumor volume using RECIST criteria|At the end of neoadjuvant therapy|8 patients were removed from the study due to adverse events|||Participants|||Count of Participants
2703782|NCT01216176|Secondary|Phase II - Cohort B: Number of Participants With Pathologic Complete Response (pCR)|A pathologic complete response will be defined as the absence of viable tumor cells in the resected specimen, as determined by standard histologic examination. All specimens will be reviewed by a central pathologist to determine pathologic response.|At completion of 4-6 cycles of therapy or after disease progression||||Participants|||Count of Participants
2703783|NCT01216176|Secondary|Phase II Cohort B: Change in Tumor Size by Comparison of Serial MRI|MRI will be used to compare tumor size at baseline and at 10 weeks. MRI will also be used to compare tumor size at baseline and after completion of 6 months of study medication or disease progression.|Baseline to 10 weeks;and baseline to 6 months|Of 59 subjects, 1 was removed at MD discretion; 8 removed due to AEs. Of the remaining 50 (31 dual + 19 mono), all had MRI at 10 weeks. 3 dual and 1 mono had disease progression and no further MRIs. 7 out of 28 (dual) & 2 out 18 (mono) completing 4 months, had end of study MRI at wk 18; 21 ( dual) and 16 (mono) had a final MRI at 24 weeks .|||percentage of tumor volume change||Standard Deviation|Mean
2703784|NCT01216176|Secondary|Phase 1-Cohort A: Peak Concentration of Each Study Drug ( AZD0530 (Saracatinib) and Anastrozole)|Summarized as the geometric means and standard deviations for the corresponding for peak plasma concentration of each study drug ( AZD0530 (saracatinib) and anastrozole) after exposure|0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 7 days, 14 days, 21 days after first dose of AZD0530||||ng/ml||Standard Deviation|Geometric Mean
2703785|NCT01216176|Secondary|Phase I - Cohort A: Plasma Concentrations of AZD0530 (Saracatinib) and Anastrozole|Summarized as mean plasma concentrations (ng/ml) of each drug (AZD0530 (saracatinib) and Anastrozole) after exposure to dual therapy.|0 hrs, 6 hrs, 12 hrs, 24hrs, 48 hrs, 72 hrs, 8 days, 15 days, 22 days after first dose of AZD0530|Day 21 - 1 missing sample.|||ng/ml||Standard Deviation|Mean
2703786|NCT01216176|Primary|Phase II - Cohort B: Compare Treatment Groups (AZD0530 + Anastrozole Versus Anastrozole With Placebo) With Respect to Clinical Response|Clinical response is defined as percentage change in tumor size calculated from bi-dimensional clinical tumor measurement at diagnosis and on completion of neoadjuvant treatment. The mean reduction in tumor size ( +/-SD) will be derived form the change in largest tumor dimension ( RECIST) and by calculated tumor volume|Baseline, cycle 6|Of 59 subjects, 2 (one/arm)tumors were not palpable at baseline; 1 was removed at MD discretion; 8 removed due to AEs . 48 (30+18) completed 4 mo of therapy and were evaluable for clinical response. Subjects completing 4 months were permitted to go tor surgery. At 24 weeks 19 dual and 16 monotherapy remained evaluable for clinical tumor size.|||percentage of tumor volume change||Standard Deviation|Mean
2703787|NCT01216176|Primary|Phase I Cohort A: Maximum Tolerated AZD0530 Daily Dose Used in Combination With Daily Oral Anastrozole|To identify a well tolerated dose of AZD0530 (saracatinib) that can be used together with anastrozole in the Phase 2 trial with tolerable toxicity and PK, subjects were followed as AEs recorded and evaluated and drug concentrations were in the therapeutic range.|Cycle 1: Days 1 - 28|All participants enrolled to phase 1.|||mg/day oral dose|||Number
2703788|NCT01216163|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703789|NCT01216163|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2703790|NCT01216163|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2703791|NCT01216163|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||hours||95% Confidence Interval|Median
2703792|NCT01216163|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2703793|NCT01216163|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2703794|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703795|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703796|NCT01216163|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703797|NCT01216163|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703798|NCT01216163|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703799|NCT01216163|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703800|NCT01216163|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2703801|NCT01216163|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2703802|NCT01216163|Primary|Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2703803|NCT01216072|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.|Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with month 3 and month 6 assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2703804|NCT01216072|Secondary|Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
2703805|NCT01216072|Secondary|Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2703806|NCT01216072|Secondary|Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4|The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
2703807|NCT01216072|Secondary|Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4|The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
2703808|NCT01216072|Secondary|Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4|The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
2703819|NCT01215968|Primary|Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy|After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.|Days 3, 10,17, 24 and 31|All randomized participants who received study drug, a radiolabeled breakfast, and had scintigraphy images taken. Those who violated protocol were excluded.|||hours||90% Confidence Interval|Geometric Mean
2703809|NCT01216072|Secondary|Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)|The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
2703810|NCT01216072|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6|The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2703811|NCT01216072|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|9 months (6 month core + 3 month Extension)|Safety Set included all patients who received at least one dose of study drug.|||Participants|||Number
2703812|NCT01216072|Primary|Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6|The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
2703813|NCT01215981|Secondary|Number of Subjects With H3 Based Immune Response to Vaccine|The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.|||Patients|||Number
2703814|NCT01215981|Primary|Number of Subjects With T-Cell Based Immune Response to Vaccine|The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.|||Patients|||Number
2703815|NCT01215968|Secondary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.|Baseline through 5 weeks|All enrolled participants who received at least one dose of study drug.|||participants|||Number
2703816|NCT01215968|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.|||hour||Full Range|Median
2703817|NCT01215968|Secondary|Maximum Concentration (Cmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2703818|NCT01215968|Secondary|Area Under the Curve (AUC) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had PK data. Those who violated protocol were excluded.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2703820|NCT01215955|Secondary|Percentage of Participants With Severe Hypoglycemic Episodes|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose.|Randomization up to 24 weeks|All randomized participants except those from the excluded site.|||percentage of participants|||Number
2703821|NCT01215955|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30.|Randomization through 24 weeks overall|All randomized participants except those from the excluded site.|||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
2703822|NCT01215955|Secondary|The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence)|A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants ≥65 years old except those from the excluded site.|||participants|||Number
2703823|NCT01215955|Secondary|The Number of Participants With a Hypoglycemic Episode (Incidence)|A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants except from the excluded site.|||participants|||Number
2703824|NCT01215955|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.|||international units/kilogram (IU/kg)||Standard Error|Least Squares Mean
2703825|NCT01215955|Secondary|Daily Dose of Insulin: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.|||international units (IU)||Standard Error|Least Squares Mean
2703826|NCT01215955|Secondary|Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile|7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and had values at baseline and the specified timepoint, except participants from the excluded site.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2703827|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG)|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline 1,5-AG value, except participants from the excluded site.|||microgram/milliliter (mcg/mL)||Standard Error|Least Squares Mean
2703828|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, who are ≥65 years of age with baseline fasting glucose values, except participants from the excluded site.|||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
2703829|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline fasting glucose values, except participants from the excluded site.|||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
2703847|NCT01215942|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)||Baseline, 240 weeks|Zero participants analyzed. DAS28-CRP data was not collected for analysis due to early termination of the study.||||||
2703830|NCT01215955|Secondary|Time to Reach Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact.|Baseline through 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site. Censored participants: Study A: ≤6.5% Q1D=186 and Q3D=197; Study A ≤7.0% Q1D=120 and Q3D=134; Study B: ≤6.5% Q1D=206 and Q3D=212, Study B ≤7.0% Q1D=135 and Q3D=152.|||percentage of participants|||Number
2703831|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Body Weight|Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction .|Baseline, 24-weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized and received ≥1 dose of study insulin with a baseline body weight, except participants from the excluded site.|||kilograms (kg)||Standard Error|Least Squares Mean
2703832|NCT01215955|Secondary|Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration|Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%.|24-week endpoint|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and were ≥65 years of age, except participants from the excluded site. Last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2703833|NCT01215955|Secondary|Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%.|24-week endpoint|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site; last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2703834|NCT01215955|Primary|Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)|The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.|Baseline, 24 weeks|Full Analysis Set: All participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with a baseline value for HbA1C, except participants from the excluded site.|||percentage HbA1c||Standard Error|Least Squares Mean
2703835|NCT01215942|Primary|Change From Baseline in Serum Immunoglobulin (Ig) Levels|Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.|Baseline, Week 48|All participants from Studies BCDO and BCDV with an evaluable serum Ig data. LOCF was used to impute missing post-baseline values.|||grams/liter (g/L)||Standard Deviation|Mean
2703836|NCT01215942|Other Pre-specified|Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period||Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period|All enrolled participants.|||Participants|||Count of Participants
2703837|NCT01215942|Secondary|American College of Rheumatology Percent Improvement (ACR-N)||Baseline through 240 weeks|Zero participants analyzed. ACR-N data was not collected for analysis due to early termination of the study.||||||
2703838|NCT01215942|Secondary|Change From Baseline in CRP||Baseline, 240 weeks|Zero participants analyzed. CRP data was not collected for analysis due to early termination of the study.||||||
2703839|NCT01215942|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)||Baseline, 240 weeks|Zero participants analyzed. HAQ-DI data was not collected for analysis due to early termination of the study.||||||
2703840|NCT01215942|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)||Baseline, 240 weeks|Zero participants analyzed. Physicians global assessment data was not collected for analysis due to early termination of the study.||||||
2703841|NCT01215942|Secondary|Change From Baseline in Participants Global Assessment of Disease Activity (VAS)||Baseline, 240 weeks|Zero participants analyzed. Participants Global assessment data was not collected for analysis due to early termination of the study.||||||
2703842|NCT01215942|Secondary|Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]||Baseline, 240 weeks|Zero participants analyzed. VAS data was not collected for analysis due to early termination of the study.||||||
2703843|NCT01215942|Secondary|Change From Baseline in Swollen Joint Count (66 Joint Count)||Baseline, 240 weeks|Zero participants analyzed. Swollen joint count data was not collected for analysis due to early termination of the study.||||||
2703844|NCT01215942|Secondary|Change From Baseline in Tender Joint Count (68 Joint Count)||Baseline, 240 weeks|Zero participants analyzed. Tender joint count data was not collected for analysis due to early termination of the study.||||||
2703845|NCT01215942|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores||Baseline, 240 weeks|Zero participants analyzed. SF-36 data was not collected for analysis due to early termination of the study.||||||
2703846|NCT01215942|Secondary|Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response||Baseline through 240 weeks|Zero participants analyzed. EULAR-28 data was not collected for analysis due to early termination of the study.||||||
2703848|NCT01215942|Secondary|Percentage of Participants With American College of Rheumatology 20% Response (ACR20)|ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.|Baseline through Weeks 12, 24 and 48|All participants from Studies BCDO and BCDV with an evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR20 was missing after carrying forward CRP, last post-baseline ACR20 response was used.|||percentage of participants|||Number
2703849|NCT01215942|Primary|Change From Baseline in Absolute B Cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.|Baseline, Week 48|All participants from Studies BCDO and BCDV with an evaluable CD3-CD20+ B cell counts. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||cells/microliter (cells/µL)||Standard Deviation|Mean
2703850|NCT01215942|Primary|Percentage of Participants Developing Anti-LY2127399 Antibodies|Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.|Baseline through Weeks 4, 24, 48 and 72|All participants from Studies BCDO and BCDV with an evaluable baseline anti-LY2127399 antibodies result and a post-baseline anti-LY2127399 antibodies result. Participants missing an evaluable baseline result with a negative post-baseline results were included.|||percentage of participants|||Number
2703851|NCT01215942|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period|A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|up to 84.4 weeks during treatment period|All enrolled participants.|||Participants|||Count of Participants
2703852|NCT01215929|Primary|Measure of Methamphetamine Withdrawal|Total score on the Methamphetamine Withdrawal Assessment scale (MAWA) based on DSMIV criteria for amphetamine withdrawal. This questionnaire is comprised of 13 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score indicating no methamphetamine withdrawal symptoms is 0 and the maximum score is 4 indicating that a patient has the most severe withdrawal symptom related to that question. The subscales are the 13 questions and the total score is the sum of all the scores for the 13 items on the scale. The range minium and better outcome is a lower score. The range is from 0-52. The worse outcome is reflected in a higher score.|at the end of week 4||||units on a scale||Standard Error|Least Squares Mean
2703853|NCT01215916|Secondary|Pharmacokinetics, Area Under the Curve (AUC) of LY573636|Area under the concentration-time curve above the albumin corrected threshold (AUCalb) is provided for LY573636, which has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.|Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)|Participants who had at least 1 evaluable AUCalb pharmacokinetic sample.|||hour*micrograms per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2703854|NCT01215916|Secondary|Pharmacokinetics, Concentration Maximum (Cmax) of LY573636||Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)|Participants who had at least 1 evaluable Cmax pharmacokinetic sample.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2703855|NCT01215916|Secondary|Percentage of Participants With a Tumor Response|Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and confirmed by repeat assessment. Complete Response (CR) was defined as the disappearance of all target lesions and the normalization of tumor marker levels for non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. Percentage of participants with a tumor response = (number of participants with CR or PR/number of enrolled participants)*100.|Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up)|All enrolled participants: those who received 1 or more doses of LY573636 or pemetrexed.|||percentage of participants|||Number
2703856|NCT01215916|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and other non-serious adverse events (AEs) regardless of causality. A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.|Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)|All enrolled participants: those who received 1 or more doses of LY573636 or pemetrexed.|||Participants|||Count of Participants
2703857|NCT01215916|Primary|Recommended Phase 2 Dose|Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where <33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored.|Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]|Enrollment was stopped during the dose-escalation phase and it was too early to assess the recommended dose for Phase 2 or to estimate the MTD, therefore zero participants were analyzed.||||||
2703858|NCT01215851|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (TTP versus Day).|14 Days|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 81.|||time (h) to positive per day||Standard Deviation|Mean
2703859|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 7-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.|||log10CFU/ml/day||Standard Deviation|Mean
2703860|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 2-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 80.|||log10CFU/ml/day||Standard Deviation|Mean
2703861|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 0-2|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number patients analyzed for this measure was 84.|||log10CFU/ml/day||Standard Deviation|Mean
2703862|NCT01215851|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|14 consecutive days of treatment|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.|||log10CFU/ml/day||Standard Deviation|Mean
2703863|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 14|Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 14|The analysis population included all patients that started the study and were treated with AGN-207281.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
2703864|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 7|Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 7|The analysis population included all patients that started the study and were treated with AGN-207281.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
2703865|NCT01215786|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14|Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Day 14|Safety population, which consisted of all patients who started the study and received treatment.|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
2703866|NCT01215734|Secondary|Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses|Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus|Before TIV and 28-42 days after TIV|Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.|||participants|||Number
2703867|NCT01215734|Primary|Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients|Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.|Day of TIV to 7 days after TIV|Patients who received either the high-dose TIV or the standard dose TIV|||participants|||Number
2703868|NCT01215721|Primary|Time to Continence|Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.|12 months||||Days to Continence||Standard Deviation|Median
2703869|NCT01215695|Secondary|Ease of Intubation|After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.|2-4 hours after intubation||||units on a scale||Standard Deviation|Mean
2703870|NCT01215695|Secondary|Laryngeal View Grade of 1 or 2|The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).|30 minutes||||Participants|||Count of Participants
2703871|NCT01215695|Secondary|Neck Movement|One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.|30 minutes|Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.|||Participants|||Count of Participants
2703872|NCT01215695|Secondary|The Number of Intubation Attempts|counted as each approach of the ETT to the glottic entrance.|30 minutes||||Number of intubation attempts||Standard Deviation|Mean
2703873|NCT01215695|Primary|Intubation Time|divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.|120 seconds||||time in seconds||Inter-Quartile Range|Median
2703874|NCT01215643|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.|within 24 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
2703875|NCT01215643|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"Viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment"|within 24 weeks of treatment|Full Analysis Set|||percentage of participants|||Number
2703876|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
2703877|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
2703878|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)||24 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
2703879|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
2703880|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
2703881|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)|SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.|12 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
2703882|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
2703883|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
2703884|NCT01215643|Secondary|Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)|ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.|at end of treatment, within 24 weeks|Full Analysis Set|||percentage of participants|||Number
2703887|NCT01215643|Secondary|Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)|cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.|after 12 weeks of treatment|Full Analysis Set|||percentage of participants|||Number
2703888|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
2703889|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
2703890|NCT01215643|Secondary|Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)|RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set|||percentage of participants|||Number
2703891|NCT01215643|Primary|Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)|RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.|||percentage of participants|||Number
2703892|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in ECG Variables|This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).|||Participants|||Number
2703893|NCT01215513|Secondary|Serum Levels of Prostate Specific Antigen (PSA) Over Time|PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).|Day 0, day 196, day 280, and day 364|CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).|||ng/mL||Full Range|Median
2703894|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).|||Participants|||Number
2703895|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|"The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.~ULN=upper limit of normal"|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).|||Participants|||Number
2703896|NCT01215435|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.|Week 0 to Week 36|Safety analysis set includes all subjects who received at least one dose of the trial product.|||episodes|||Number
2703897|NCT01215435|Secondary|Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 weeks of treatment|Week 0, Week 36|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
2703898|NCT01215435|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11|Estimated mean change from baseline in HbA1c after 11 weeks of treatment|Week 0, Week 11|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)|||percentage of glycosylated haemoglobin||Standard Error|Mean
2703899|NCT01215422|Secondary|"Number of Intubation Attempts to Reach Best Obtainable Time to Intubation"|"For each anesthesiologist, the median time-to-intubation for patients #1-5, #6-10, #11-15, and #16-20 was determined. The anesthesiologist was considered to have reached Best Obtainable Time (BOT) to Intubation once the median time on any group of 5 consecutive patients was less than 3 seconds faster than the median time in the previous group of 5 consecutive patients, provided that there were no failed intubations or subsequent failed intubations using the same device."|less than 5 minutes per intubation||||participants|||Number
2703900|NCT01215422|Secondary|Mean Years Since Completion of Anesthesiology Residency|To investigate whether there was a correlation between the years since completion of anesthesiology residency to the mid-point of study (2008)and median time-to-intubation for all first attempt intubations for the study. Years since completion of anesthesiology residency reported in the data table, correlation reported in the statistical analysis below|Baseline (assessed as of 2008)||||years||Full Range|Mean
2703901|NCT01215422|Secondary|Time to Intubation, Stratified by Weight of Patients|To compare the time-to-intubation for these laryngoscopes in children of different weights.|4 years|Time to Intubation, Stratified by Weight of Patients|||seconds||Standard Deviation|Mean
2703902|NCT01215422|Secondary|Time to Intubation, Analyzed by Order of Laryngoscopes Used|To determine if the learning curve was altered by the order in which the two new laryngoscopes were learned by the anesthesiologist,mean and median times on intubations #16-20 were compared for the two videolaryngoscopes.|4 years|Only anesthesiologists who completed minimum 18 intubations with each scope were included. We report the mean of their mean times and the mean of their median times on intubations #16-20 when they should have attained a reasonable skill level.|||seconds|Participants|Standard Deviation|Mean
2703947|NCT01215253|Other Pre-specified|Number of Patients Whose First VT/VF Required ICD Shock|number of patients whose first VT or VF required ICD shock|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703903|NCT01215422|Secondary|Cormack & Lehane Score|This Outcome was designed to determine if the view of the airway as determined by the Cormack & Lehane grading system is improved by use of the GlideScope (GS) video laryngoscope and/or the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope as this would be a surrogate marker for utility in a difficult airway. Score is reported as a whole number from I to IV with I being an easy intubation and IV being one where the larynx cannot be visualized at all.|reported during intubation (up to 5 minutes)|Patients were excluded if the Cormack-Lehane score was not recorded.|||Percentage of participants|||Number
2703904|NCT01215422|Primary|Success in Learning to Use a Videolaryngoscope(VLS)|"Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. Rapid Success was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . Delayed Success was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having No Success."|Up to 5 minutes per intubation|Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome.|||percent of anesthesiologists|Participants||Number
2703905|NCT01215357|Secondary|Effects on the Clinical Global Impression|Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study|6 weeks|||||||
2703906|NCT01215357|Secondary|Statistically Significant Changes in the Gambling Symptom Assessment Scale|It is expected that there will be decreases in this scale|6 weeks|||||||
2703907|NCT01215357|Secondary|Type, Frequency and Severity of Side Effects|All side effects of the drug will be monitored and recorded|6 weeks|||||||
2703908|NCT01215357|Primary|Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling|This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.|Baseline and 6 weeks|Patients completing all visits|||YBOCS score||Standard Deviation|Mean
2703909|NCT01215344|Secondary|Progression Free Survival by MRD Status at Day 100.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 7 years|Patients with MRD status information at the EOI and day 100 (post-AHCT).|||years||95% Confidence Interval|Median
2703910|NCT01215344|Primary|The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).|Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.|6-months post ASCT|Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.|||percentage of participants||95% Confidence Interval|Number
2703911|NCT01215318|Secondary|Tampon Position Relative to the Pubococcygeal Line|measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination.|1 month||||mm|vaginal tampons|Standard Deviation|Mean
2703912|NCT01215318|Primary|Number of FDG Positive Tampoons|Number of FDG positive Tampoons with an SUV > 3|1 month||||FDG positive tampons|vaginal tampons||Number
2703913|NCT01215292|Primary|Intratesticular Androstenedione (ADD) Level||10 days||||ng/mL||Inter-Quartile Range|Median
2703914|NCT01215292|Primary|Intratesticular Dihydrotestosterone (DHT) Level||10 days||||ng/mL||Inter-Quartile Range|Median
2703915|NCT01215292|Primary|Intratesticular Testosterone (IT-T) Level||10 days||||ng/mL||Inter-Quartile Range|Median
2703916|NCT01215279|Secondary|Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||L||Full Range|Geometric Mean
2703917|NCT01215279|Secondary|Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||Hours||Full Range|Median
2703918|NCT01215279|Secondary|Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||nmol/L||Full Range|Geometric Mean
2703919|NCT01215279|Secondary|Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||nmol*h/L||Full Range|Geometric Mean
2703920|NCT01215279|Secondary|SAA Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4||||ng/mL||Full Range|Geometric Mean
2703921|NCT01215279|Secondary|Serum Amyloid-A (SAA) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1||||ng/mL||Full Range|Geometric Mean
2703922|NCT01215279|Secondary|CCL2 Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4||||pg/mL||Full Range|Geometric Mean
2703923|NCT01215279|Secondary|CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1||||pg/mL||Full Range|Geometric Mean
2703924|NCT01215279|Secondary|SGRQ Total Score at End of Treatment|Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference.|week 4||||Percent of maximum possible score||Standard Deviation|Mean
2705596|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2703925|NCT01215279|Secondary|St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline|The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1.|Day 1||||Percent of maximum possible score||Standard Deviation|Mean
2703926|NCT01215279|Secondary|Rescue Medication Use During the Last 7 Days of Treatment|Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.|Average of the last 7 days of treatment (week 4)||||Inhalations||Full Range|Mean
2703927|NCT01215279|Secondary|BCSS (Evening) Total Score During Last 7 Days of Treatment|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units.|Average of the last 7 days of treatment (week 4)||||Units on scale, 0-12||Standard Deviation|Mean
2703928|NCT01215279|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||Units on scale, 0-12||Standard Deviation|Mean
2703929|NCT01215279|Secondary|EXACT Total Score During Last 7 Days of Treatment|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation).|Average of the last 7 days of treatment (week 4)||||Units on scale, 0-100||Standard Deviation|Mean
2703930|NCT01215279|Secondary|Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation.|Average of 7 days of pre-treatment measurements (day -7 to -1)||||Units on scale, 0-100||Standard Deviation|Mean
2703931|NCT01215279|Secondary|Evening PEF During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)||||L/minute||Standard Deviation|Mean
2703932|NCT01215279|Secondary|Evening PEF at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L/minute||Standard Deviation|Mean
2703933|NCT01215279|Secondary|Morning PEF During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)||||L/minute||Standard Deviation|Mean
2703934|NCT01215279|Secondary|Morning Peak Expiratory Flow (PEF) at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L/minute||Standard Deviation|Mean
2703935|NCT01215279|Secondary|Evening FEV1 During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)||||L||Standard Deviation|Mean
2703936|NCT01215279|Secondary|Evening FEV1 at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L||Standard Deviation|Mean
2703937|NCT01215279|Secondary|Morning FEV1 During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)||||L||Standard Deviation|Mean
2703938|NCT01215279|Secondary|Morning FEV1 at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L||Standard Deviation|Mean
2703939|NCT01215279|Primary|Monocytes at Follow-up|Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)|week 5 (follow-up)||||10^9/L||Standard Deviation|Mean
2703940|NCT01215279|Primary|Monocytes at End of Treatment|Monocyte count in peripheral blood at end of treatment (4 weeks)|week 4||||10^9/L||Standard Deviation|Mean
2703941|NCT01215279|Primary|Monocytes at Baseline|Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)|Day 1||||10^9/L||Standard Deviation|Mean
2703942|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Physical Examination|Number of participants with clinically significant changes in physical examination assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
2703943|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in ECG Variables|Number of participants with clinically significant changes in ECG variables assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
2703944|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Number of participants with clinically significant changes in vital signs assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
2703945|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes|Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
2703946|NCT01215253|Secondary|Number of Recurrent Inappropriate ICD Shocks|Number of recurrent inappropriate ICD shocks in all patients combined.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||events|||Number
2703948|NCT01215253|Other Pre-specified|Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP)|Number of patients whose first VT or VF required antitachycardia pacing (ATP)|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703949|NCT01215253|Secondary|Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. The scale ranges from 0-100 with lower scores indicating worse outcomes.|1 year follow-up|Data was not collected in 42 patients in the placebo arm and 61 patients in the Ranolazine arm.|||units on a scale||Standard Deviation|Mean
2703950|NCT01215253|Secondary|Mean Meters Walked in 6 Minutes|Exercise capacity measured by the 6-minute walk test|1 year of follow-up|Data was not collected on 86 patients in the placebo arm and 99 patients in the Ranolazine arm.|||meters||Standard Deviation|Mean
2703951|NCT01215253|Secondary|Death|Death as a safety endpoint of the trial|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703952|NCT01215253|Secondary|Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First|Number of patients with a composite endpoint of heart failure hospitalization or death, whichever occurred first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703953|NCT01215253|Secondary|Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First.|Number of patients with a composite endpoint of cardiovascular hospitalization or death, whichever occurred first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703954|NCT01215253|Secondary|Number of Patients With First Inappropriate ICD Shock|Number of patients with first inappropriate ICD shock for other reasons than VT or VF|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703955|NCT01215253|Secondary|Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies|Total number of recurrent ICD therapies requiring antitachycardia pacing (ATP) or shock will be analyzed, not just first event|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||VT/VF events|VT/VF events||Count of Units
2703956|NCT01215253|Secondary|Number of Patients With VT or VF Requiring ICD Shock or Death|Implantable cardioverter-defibrillator (ICD) shock for VT or VF or death, whichever occurs first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703957|NCT01215253|Primary|Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death|Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
2703958|NCT01215240|Secondary|Hospital Length of Stay||Assessed up to 8 weeks||||days||Standard Deviation|Mean
2703959|NCT01215240|Secondary|Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5|The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes.|Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported||||score on a scale||Standard Deviation|Mean
2703960|NCT01215240|Secondary|Time to First Extubation||Up to 15 days||||days||Standard Deviation|Mean
2703961|NCT01215240|Secondary|Time to Lactate Less Than or Equal to 2mmol/L|Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs|From time of admission in PICU until assessment was reached, assessed up to 24 hours||||Hours||Standard Deviation|Mean
2703962|NCT01215240|Secondary|Time to Sternal Closure||Up to 200 hours||||days||Standard Deviation|Mean
2703963|NCT01215240|Primary|Time to First Post-operative Negative 24 Hour Fluid Balance|Time to first post-operative negative fluid balance which occurred in first 72 hrs|up to 72 hours||||Days||Standard Deviation|Mean
2703964|NCT01215227|Primary|Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40|The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness.|Baseline and Week 40|Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score|||Percentage change||95% Confidence Interval|Mean
2703965|NCT01215227|Primary|Percentage of Participants With Suicidality|The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2704030|NCT01214980|Secondary|Numeric Itching Score|Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure|5 weeks|Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported|||units on a scale||Standard Error|Mean
2703966|NCT01215227|Primary|Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2703967|NCT01215227|Primary|Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2703968|NCT01215227|Primary|Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg|The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2703969|NCT01215227|Primary|Percentage of Participants With Systolic Blood Pressure ≥180 mmHg|The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2703970|NCT01215188|Secondary|Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4|Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.|One month postvaccination 4|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703971|NCT01215188|Secondary|Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4|Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.|One month postvaccination 4|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703972|NCT01215188|Secondary|OPA GMTs as Measured by MOPA4 for Postvaccination 4|The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.|One month postvaccination 4|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||μg/mL||95% Confidence Interval|Geometric Mean
2703973|NCT01215188|Secondary|OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3|The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.|One month postvaccination 3|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||μg/mL||95% Confidence Interval|Geometric Mean
2703974|NCT01215188|Secondary|Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4|The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.|One month postvaccination 4|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703975|NCT01215188|Secondary|Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3|The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.|One month postvaccination 3|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703976|NCT01215188|Primary|Number of Participants Who Discontinued the Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.|Up to Day 14 postvaccination|The analysis population included all randomized participants who received at least one dose of study vaccination.|||Participants|||Count of Participants
2703977|NCT01215188|Primary|Number of Participants With a Serious Adverse Event (SAE)|An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.|Up to one month after last dose of study vaccine|The analysis population included all randomized participants who received at least one dose of study vaccination.|||Participants|||Count of Participants
2703978|NCT01215188|Primary|Number of Participants With a Systemic AE|Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed.|Up to Day 14 postvaccination||||Participants|||Count of Participants
2703979|NCT01215188|Primary|Number of Participants With an Injection-site AE|Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed.|Up to Day 14 postvaccination|The analysis population included all randomized participants who received at least one dose of study vaccination.|||Participants|||Count of Participants
2703980|NCT01215188|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.|Up to Day 14 postvaccination|The analysis population included all randomized participants who received at least one dose of study vaccination.|||Participants|||Count of Participants
2703981|NCT01215188|Primary|IgG GMCs for Postvaccination 4|The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.|One month postvaccination 4|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||µg/mL||95% Confidence Interval|Geometric Mean
2703982|NCT01215188|Primary|IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3|The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.|One month postvaccination 3|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||µg/mL||95% Confidence Interval|Geometric Mean
2703983|NCT01215188|Primary|Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3|Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence [Pn ECL] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay [WHO ELISA] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.|One month postvaccination 3|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703984|NCT01215175|Secondary|Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)|OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay|Day 30 after vaccination|The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Titer||95% Confidence Interval|Geometric Mean
2703985|NCT01215175|Secondary|Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)|OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay|Day 30 after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Titer||95% Confidence Interval|Geometric Mean
2703986|NCT01215175|Secondary|Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8|OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.|Day 30 after vaccination|The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703987|NCT01215175|Secondary|Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8|OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.|Day 30 after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703988|NCT01215175|Secondary|Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|Day 30 after vaccination|The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||µg/mL||95% Confidence Interval|Geometric Mean
2703989|NCT01215175|Secondary|Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|Day 30 after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||µg/mL||95% Confidence Interval|Geometric Mean
2703990|NCT01215175|Secondary|Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL|Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.|Day 30 after vaccination|The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703991|NCT01215175|Secondary|Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL|Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.|Day 30 after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.|||Percentage of Participants||95% Confidence Interval|Number
2703992|NCT01215175|Primary|Toddler: Percentage of Participants With Any Vaccine-related Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.|Up to Day 14 after vaccination|The analysis population included all randomized toddler participants who received study vaccination and who had available post-treatment safety data.|||Percentage of Participants|||Number
2703993|NCT01215175|Primary|Adult: Percentage of Participants With Any Vaccine-related Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.|Up to Day 14 after vaccination|The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.|||Percentage of Participants|||Number
2703994|NCT01215175|Primary|Toddler: Percentage of Participants With Any Serious Adverse Event|A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.|Up to Day 14 after vaccination|The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.|||Percentage of Participants|||Number
2703995|NCT01215175|Primary|Adult: Percentage of Participants With Any Serious Adverse Event|A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.|Up to Day 14 after vaccination|The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.|||Percentage of Participants|||Number
2703996|NCT01215175|Primary|Toddler: Percentage of Participants With Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Day 14 after vaccination|The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.|||Percentage of Participants|||Number
2703997|NCT01215175|Primary|Adult: Percentage of Participants With Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Day 14 after vaccination|The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.|||Percentage of Participants|||Number
2703998|NCT01215123|Secondary|Treatment Duration: Number of Bevacizumab Cycles|Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.|Up to a maximum of 36.4 months|All enrolled participants|||cycles||Full Range|Median
2703999|NCT01215123|Primary|Time to Disease Progression (TDP)|Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to a maximum of 36.4 months|All enrolled participants|||months||Full Range|Median
2704000|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Area Under the Concentration-time Curve Over the Dose Interval of 0 to 24 h (AUC(0-24)) on Day 1 and Day 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants|||ng*h/mL||Standard Deviation|Mean
2704001|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Time of Maximum Plasma Concentration (T(Max)) on Days 1 and 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants|||hour||Standard Deviation|Mean
2704002|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Maximum Plasma Concentration Following Dosing (C(Max)) on Days 1 and 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants|||ng/mL||Standard Deviation|Mean
2704003|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 7-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Days 7-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
2704004|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Days 2-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
2704005|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Two consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
2704006|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
2704007|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since this range (Days0-2) is before the node day, the rate of change for this outcome is equal to the slope at Day 0. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Two consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
2704008|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Days 2-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
2704009|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since Day 7 is later than the node day, the rate of change for this outcome is equal to the slope at Day 14. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Days 7-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
2704010|NCT01215110|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
2704011|NCT01215097|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
2704012|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
2704013|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
2704014|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
2704015|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
2704016|NCT01215097|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704017|NCT01215097|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704018|NCT01215097|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704019|NCT01215097|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704020|NCT01215097|Secondary|HbA1c Change From Baseline at Week 24(Chinese Only)|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at 24 weeks|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (Chinese only). Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2704021|NCT01215097|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2704022|NCT01215097|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2704023|NCT01215097|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2704024|NCT01215097|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2704025|NCT01215032|Secondary|Percent Maintaining Glycemic Control|To describe glycemic control as assessed by hemoglobin A1C. Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL. Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.|2 years|Participants were stratified based on baseline hemoglobin A1c. HbA1c < 6.0 is considered normal; HbA1c >/= 6.0 is considered abnormal.|||Participants|||Count of Participants
2704026|NCT01215032|Secondary|Relationship Between Baseline Metabolomic Profile and PSA Response|To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform. The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics. The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.|2 years|Data was not collected for this outcome measure because blood (plasma) samples were never run on the Metabolon platform, as the study was terminated early.||||||
2704027|NCT01215032|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.|12 weeks||||Participants|||Count of Participants
2704028|NCT01215032|Primary|PSA (Prostate Specific Antigen) Response|Percent change in PSA from baseline to 12 weeks.|Approximately 12 weeks||||percentage of baseline PSA||Full Range|Median
2704029|NCT01214980|Secondary|Donor Site Recidivism Rate|Number of donor sites that healed and then reopened during the study.|6 weeks|Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study.|||participants that healed and reopened|||Number
2705597|NCT01202253|Secondary|Percentage of Participants Who Received 100 mg Dose on Day 2||Day 2|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2704031|NCT01214980|Secondary|Numeric Pain Score|Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure|5 weeks|randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported|||units on a scale||Standard Error|Mean
2704032|NCT01214980|Secondary|Time to Full Epithelialization|Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.|Days to full epithelialization|randomized subjects that had a minimum of 4 out of 5 study treatments|||days||Standard Deviation|Mean
2704033|NCT01214980|Primary|Rate of Wound Healing|The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.|Days to absence of drainage from the initial donor site harvest procedure|randomized participants that had a minimum of 4 out of 5 treatments|||Days||Standard Deviation|Mean
2704034|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
2704035|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
2704036|NCT01214915|Secondary|Percentage of Subjects With Normalization in Platelet Count|Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
2704037|NCT01214915|Secondary|Percentage of Subjects With at Least 50% Reduction in Platelet Count|Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
2704038|NCT01214915|Primary|Percentage of Subjects Who Responded in Platelet Count|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
2704039|NCT01214850|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group|The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.|Day 1 through day 7 after any vaccination|Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.|||number of subjects|||Number
2704040|NCT01214850|Secondary|Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.|"The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.~Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Percentages of subjects||95% Confidence Interval|Number
2704041|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group|"The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.~Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Titers||95% Confidence Interval|Geometric Mean
2704042|NCT01214850|Secondary|Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.|"The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.~Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.~Analysis was not done for serogroups A and W."|61 days|Analysis was done on the MITT dataset (Immunogenicity subset)|||Percentages of subjects||95% Confidence Interval|Number
2704043|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.~Serogroups A and W were not analysed."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Titers||95% Confidence Interval|Geometric Mean
2704138|NCT01214616|Secondary|AUCτ,ss for Afatinib|area under the plasma concentration-time curve following dose at steady state over the dosing interval τ|"pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as with Vinorelbine) and 20th dose (as without Vinorelbine)"|Treated set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2704044|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.~As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Percentages of subjects||95% Confidence Interval|Number
2704045|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Titers||95% Confidence Interval|Geometric Mean
2704046|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group|The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.|||Percentages of subjects||95% Confidence Interval|Number
2704047|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers|The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.|Up to 12 months after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704048|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination|"The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.~The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).~H44/76, 5/99 and NZ98/254 are strains in serogroup B."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentage||95% Confidence Interval|Number
2704049|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
2704050|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
2704051|NCT01214850|Secondary|The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM|The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.|Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
2704052|NCT01214850|Secondary|The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV|The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
2704053|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704054|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704055|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2705598|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Loading Dose||Day 1|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2704056|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704057|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704058|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704059|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704060|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704061|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704062|NCT01214850|Secondary|Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704063|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704064|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MIIT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704065|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704066|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704067|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704068|NCT01214850|Secondary|Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2705599|NCT01202253|Secondary|Percentage of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2704069|NCT01214850|Secondary|Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704070|NCT01214850|Secondary|Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704071|NCT01214850|Secondary|Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination|The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704072|NCT01214850|Primary|Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination|The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|31 days after MenACWY-CRM injection|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
2704073|NCT01214850|Primary|Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination|"Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.~Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010."|61 days (31 days after receiving the second injection)|Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
2704074|NCT01214837|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.||13 months of age|Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.|||Subjects|||Number
2704075|NCT01214837|Secondary|Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.|Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.|Day 1 through Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data|||Subjects|||Number
2704076|NCT01214837|Secondary|Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.|Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.|Within 7 days|Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data|||Percentage of subjects|||Number
2704077|NCT01214837|Secondary|Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.|Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.|13 months of age.|Analysis was done on the Toddler PPS.|||µg/mL||95% Confidence Interval|Geometric Mean
2704078|NCT01214837|Secondary|Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.|Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.|7 months of age.|Analysis was done on the Infant PPS.|||Percentage of subjects||95% Confidence Interval|Number
2704079|NCT01214837|Secondary|Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.|The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.|||Percentage of subjects||95% Confidence Interval|Number
2704080|NCT01214837|Secondary|GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.|Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.|||Titers||95% Confidence Interval|Geometric Mean
2704081|NCT01214837|Secondary|Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.|The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age|Analysis was done on the Toddler PPS.|||Titers||95% Confidence Interval|Geometric Mean
2704082|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.|Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age.|Analysis was done on the Toddler PPS.|||Percentage of subjects||95% Confidence Interval|Number
2704083|NCT01214837|Secondary|Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.|Analysis was done on the Infant PPS.|||Titers||95% Confidence Interval|Geometric Mean
2704084|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.|Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age|Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.|||Percentages of subjects||95% Confidence Interval|Number
2704085|NCT01214837|Primary|Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.|13 months of age|Analysis was done on Toddler PPS.|||Percentage of subjects||95% Confidence Interval|Number
2704086|NCT01214837|Primary|Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.|13 months of age|Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.|||Percentage of subjects||95% Confidence Interval|Number
2704087|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked|Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase|2 weeks following baseline & 3 months|Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2|||Hours per day||Standard Deviation|Mean
2704088|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked|Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.|Baseline & 6 months|Analysis per protocol|||Hours per day||Standard Deviation|Mean
2704089|NCT01214824|Secondary|Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%|Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).|Baseline and 6 months|Intention to treat analysis|||participants|||Number
2704090|NCT01214824|Primary|Change in HbA1C From Baseline to 6 Months|HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months - baseline)|Baseline and 6 months|Intention to treat analysis|||HbA1c %||Standard Deviation|Mean
2704091|NCT01214811|Primary|Wound Area at Visit 2|At each visit the wound length and width is measured and calculated in cm2.|After one week||||cm2||Standard Deviation|Mean
2704092|NCT01214811|Primary|Wound Are at Baseline||Baseline|||||||
2704093|NCT01214759|Secondary|Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study||28 days|All who were enrolled|||participants|||Number
2704094|NCT01214759|Secondary|Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study|Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.|28 days|Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.||||||
2704095|NCT01214759|Primary|Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months|This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.|6 months|All who completed all study visits|||participants|||Number
2704096|NCT01214720|Secondary|Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib|Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment.|Weeks 1, 3, 5, 7, and 9|ITT Population. Number (n) = number of participants assessed at a specific visit.|||micrograms/milliliter||Standard Deviation|Geometric Mean
2704097|NCT01214720|Primary|Duration of Overall Survival - Time to Event|Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT Population.|||months||95% Confidence Interval|Median
2704139|NCT01214616|Primary|Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course|DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)|during 1st course|Treated set: all patients who received at least 1 dose of investigational medication (afatinib or vinorelbine)|||participants|||Number
2704098|NCT01214720|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment|Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits.|Baseline and Week 8|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2704099|NCT01214720|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT Population|||months||95% Confidence Interval|Median
2704100|NCT01214720|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT population.|||percentage of participants|||Number
2704101|NCT01214720|Secondary|Clinical Benefit Response (CBR)||Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|The analysis of the CBR was dependent on the calculation of analgesic therapy (AT); this calculation relies on established conversion factors for different morphine derivatives (MD). Many MD utilized by participants do not have well-established conversion factors, yielding uninterpretable results. Therefore, CBR was not analyzed in this study.||||||
2704102|NCT01214720|Primary|Duration of Overall Survival - Percentage of Participants With an Event|Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT population.|||percentage of participants|||Number
2704103|NCT01214668|Other Pre-specified|Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment||From date of randomization until up to 30 days post study treatment discontinuation, assessed up to 4.7 months|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2704104|NCT01214668|Secondary|Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)|LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.|Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3|Participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate AUCalb at the specified time points.|||hour*micrograms per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2704105|NCT01214668|Secondary|Number of Participants With Tumor Response|Number of participants with tumor response = number of participants with complete response (CR) + number of participants with partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in the sum of longest diameter of target lesions.|Baseline to measured progressive disease up to 4.7 months|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2704106|NCT01214668|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose, 30 minutes (min), 2 hours (h), 4 h, 166 h, 360 h and 698 h postdose in Cycle 1; Predose, 30 min, 2 h, 4 h, 166 h, 360 h and 698 h postdose in Cycle 2; Predose, 166h, 360h and 698 h postdose in Cycle 3|Participants who received the study drug and had sufficient pharmacokinetic (PK) data to estimate Cmax at the specified time points.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2704107|NCT01214668|Secondary|Number of Participants With Clinically Significant Events|Clinically significant events are defined as serious adverse events (SAEs), regardless of causality, during the study including the 30-day follow-up period. A summary of SAEs and other nonserious adverse events is located in the Reported Adverse Event section. Death due to progressive disease was not considered as an SAE.|Baseline to study completion up to 18.49 months|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2704140|NCT01214603|Secondary|Number of Participants Who Died|The number of participants who died while on study treatment and the number of participants who died during the 30-day follow-up (30 days post last dose) are reported.|Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)]|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2705600|NCT01202253|Secondary|Number of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
2704108|NCT01214668|Primary|Recommended Phase 2 Dose|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which is corrected for the participant's predose albumin to identify the albumin-corrected exposure range of LY 573636 when combined with liposomal doxorubicin. MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) in the first 28-day cycle of treatment. DLT is an adverse event (AE) that is likely related to the study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity; Gr 3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments. Those who enter the study with Gr 2 hepatic enzyme abnormalities, DLT for an isolated Gr 3 hepatic enzyme abnormality is determined by investigators; a DLT can be declared if a participant experiences increasing toxicity during treatment.|Predose up to 28 days postdose in Cycle 1|All participants who received at least one dose of the study drug.|||micrograms per milliliter (μg/mL)|||Number
2704109|NCT01214655|Other Pre-specified|Death of Participants on Study up to the Follow-up Period|"The number of participants who died through the follow-up period of the study. This does not include the outcomes for the two participants who died while on treatment through Cycle 2 as captured in the Participant Flow Table.~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline up to end of treatment follow-up (up to 213 days)|Participants who received at least one dose of study medication (LY2523355).|||Participants|||Count of Participants
2704110|NCT01214655|Secondary|Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria|Response rate for participants with acute lymphoblastic leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute lymphoblastic leukemia by early treatment assessment, morphologic leukemia-free state (less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells) and morphologic complete remission (and have an absolute neutrophil count of more than 1000 per microliter and platelets of 100,000 per microliter.|Baseline up to disease progression or discontinuation (up to 213 days)|Participants with acute lymphoblastic leukemia who received at least one dose of study medication (LY2523355).|||percentage of responders|||Number
2704111|NCT01214655|Secondary|Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase)|Response rate for participants with chronic myelogenous leukemia in blast crisis include the proportion of participants who achieved a complete hematologic response, had no evidence of leukemia, or had returned to chronic phase. The criteria outlined in Cohen 2005 (Cohen MH, Johnson JR, Pazdur R. 2005. U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res. 11(1):12-19.) was used to determine response rate for participants with chronic myelogenous leukemia in blast crisis.|Baseline up to disease progression or discontinuation (up to 213 days)|Participants with chronic myelogenous leukemia in blast crisis who received at least one dose of study medication (LY2523355).|||percentage of responders|||Number
2704112|NCT01214655|Secondary|Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria|Response rate for participants with acute myelogenous leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute myelogenous leukemia.|Baseline up to disease progression or discontinuation (up to 213 days)|Participants with acute myelogenous leukemia who received at least one dose of study medication (LY2523355).|||percentage of responders|||Number
2704113|NCT01214655|Secondary|Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose|"The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours.~The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity..~Multiple dose LY2523355 AUC values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day [mg/m^2/day], 12 mg/m^2/day, and 14 mg/m^2/day). Individual data will be presented."|Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdose|Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data on Cycle 1 Day 3 or Day 9, schedule dependent.|||nanograms hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2704114|NCT01214655|Secondary|Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose|"The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours.~The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity.~Single dose LY2523355 AUC values are shown for each dose level for Day 1 of Cycle 1 for both schedules of administration. When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day [mg/m^2/day], 14 mg/m^2/day, 12 mg/m^2/day and 16 mg/m^2/day). Individual data will be presented."|Day 1, Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose|Participants who received one dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC on Day 1 of Cycle 1.Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data.|||nanagram hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2704169|NCT01214239|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704115|NCT01214655|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose|The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355. Multiple dose LY2523355 plasma Cmax values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.|Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose|Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data, Schedules A,B,C.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704116|NCT01214655|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose|The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.|Cycle 1(Day 1),: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose|Participants who received one dose of LY2523355 on Day 1 of Cycle 1(Schedule A,B,C) with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1. Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704117|NCT01214655|Secondary|Number of Participants With Clinically Significant Effects|"Clinically significant effects were defined as serious and other non-serious adverse events (AEs).~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline up to study completion (up to 213 days)|Participants who received at least one dose of study medication (LY2523355).|||Participants|||Count of Participants
2704118|NCT01214655|Primary|Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia|The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis.|Baseline up to the end of Cycle 2 (Day 42)|Participants who received at least one dose of study medication (LY2523355).|||mg/m^2/day; Days 1, 2, and 3|||Number
2704119|NCT01214642|Secondary|Number of Participants With Tumor Response|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR.|Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles)|All participants who received 1 dose of LY2523355.|||participants||90% Confidence Interval|Number
2704120|NCT01214642|Secondary|Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose|Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 2 doses of study drug and had pharmacokinetic samples collected on Day 4, 5, 8, or 9 of Cycle 1 (based on schedule of administration) to enable calculation of AUC(0-∞) and AUC(0-24) after multiple dose administration of LY2523355.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2704121|NCT01214642|Secondary|Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose|Plasma AUC from time zero to infinity [AUC(0-∞)] and AUC from time zero to 24 hours post-dose [AUC(0-24)] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 1 dose of LY2523355 and had pharmacokinetic samples collected on Day 1 of Cycle 1 to enable calculation of AUC(0-∞) and AUC(0-24).|||nanograms*hour/milliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2704122|NCT01214642|Secondary|Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose|Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 2 doses of study drug and had a Cmax sample collected on Days 4, 5, 8 or 9 of Cycle 1 (based on schedule of administration) after multiple dose administration of LY2523355.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704123|NCT01214642|Secondary|Pharmacokinetics Maximum Concentration (Cmax), Single Dose|Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 1 dose of LY2523355 and had Cmax samples collected on Day 1 of Cycle 1.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704124|NCT01214642|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module.|Baseline to Cycle 38 (21-day cycles): daily for AEs|All participants who had at least 1 dose of LY2523355.|||Participants|||Count of Participants
2704170|NCT01214239|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704125|NCT01214642|Primary|Recommended Dose and Schedule for Phase 2 Studies|The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of >5 days duration, excluding thrombocytopenia; febrile neutropenia.|Cycle 1 (21 days): Day 1, 5 and 9, any AE reported|All participants who received at least 1 dose of LY2523355.|||mg/m^2/day|||Number
2704126|NCT01214629|Secondary|Number of Participants With Tumor Response|Data presented are the number of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions.|Baseline to measured disease progression or discontinuation up to 617 days|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2704127|NCT01214629|Secondary|Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses|AUC(0-∞) following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1, Day 3(21-day cycle): End of infusion|All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 3 of Cycle 1.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2704128|NCT01214629|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose|AUC(0-∞) following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime|All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 1 of Cycle 1.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2704129|NCT01214629|Secondary|Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses|Cmax following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1, Day 3(21-day cycle): End of infusion|All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable determination of the LY2523355 Cmax on Day 3 of Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704130|NCT01214629|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose|Cmax following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime|All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1 of Cycle 1.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704131|NCT01214629|Secondary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered clinically significant effects. Data presented are the number of participants who experienced serious AEs (SAEs), other non-serious AEs and deaths during the study, including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion including 30-day follow-up up to 647 days,any AE reported|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2704132|NCT01214629|Primary|Recommended Dose for Phase 2 Studies|Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused <1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of >5 days duration; any febrile neutropenia.|Baseline, daily up to 21 days in Cycle 1|All enrolled participants who received at least 1 dose of study drug.|||mg/m²/day|||Number
2704133|NCT01214616|Primary|Drug-related Adverse Events|Number of patients with drug-related adverse events|during the treatment period or up to 28 days after the completion of drug administration, up to 730 days|Treated set|||participants|||Number
2704134|NCT01214616|Secondary|Objective Tumour Response|"According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Pre-treatment, every 8 weeks after start of study treatment, end of treatment|Treated set|||participants|||Number
2704135|NCT01214616|Secondary|Cmax for Vinorelbine|maximum measured blood concentration|"predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as with afatinib) and 1st dose (as without afatinib)"|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704136|NCT01214616|Secondary|AUC0-∞ for Vinorelbine|area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity|"predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as with afatinib) and 1st dose (as without afatinib)"|Treated set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2704137|NCT01214616|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration at steady state|"pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as with Vinorelbine) and 20th dose (as without Vinorelbine)"|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704141|NCT01214603|Secondary|Percent Change From Predose Beta (β)-Catenin Levels|Percent change=[(β-catenin level postdose-predose level)/(predose β-catenin levels)]*100. Participants in Cohort 1 had β-catenin samples collected on Cycle 1: D1, D8, and D15, and Cycles 2 through 9: D1. Participants in Cohort 2 had β-catenin samples collected on Cycle 1: D1, D5, and D9 and Cycles 2 through 9: D1. Participants in Cohort 3 had β-catenin samples collected on Cycle 1: D1, D5, D9, and D12 and Cycles 2 through 9: D1.|Cycle 1: D1 and D9 (predose, 1 h, 2 h, 4 h, 8 h, and 24 h after infusion started); Cycle 1: D5, D8, and D12 and C2 through C9: D1 (predose, 2 h after infusion started); Cycle 1: D15 (predose, 1 h, 2 h, 4 h, and 8 h after infusion started)|Participants who received at least 1 dose of study drug and had a predose and at least 1 postdose β-catenin sample collected.|||percent change||Standard Deviation|Mean
2704142|NCT01214603|Secondary|PK: Maximum Concentration (Cmax)|Cmax is the maximum observed concentration estimated from the plasma drug concentration time profile.|Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)]|Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.|||nanograms per milliliter (ng/mL)|Profiles|Geometric Coefficient of Variation|Geometric Mean
2704143|NCT01214603|Secondary|PK: AUC From Time 0 to Infinity [AUC(0-inf)]|AUC(0-inf) was estimated from the plasma drug concentration time profile.|Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)]|Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.|||ng*h/mL|Profiles|Geometric Coefficient of Variation|Geometric Mean
2704144|NCT01214603|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)]|AUC(0-8) was estimated from the plasma drug concentration time profile.|Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)]|Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.|||nanograms*hours per milliliter (ng*h/mL)|Profiles|Geometric Coefficient of Variation|Geometric Mean
2704145|NCT01214603|Secondary|Percentage of Participants With Best Response of Complete Response or Partial Response|The Revised International Working Group criteria were used to determine the response for participants with AML. Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as <5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100*10^9/L and ANC ≥1*10^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Percentage of participants=[(number of participants with CR or PR)/(number of participants treated)]*100.|Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles)|Participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2704146|NCT01214603|Secondary|Number of Participants With Best Response of Complete Response or Partial Response|The Revised International Working Group criteria were used to determine the response for participants with acute myelogenous leukemia (AML). Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as <5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100*10^9/Liter (L) and absolute neutrophil count (ANC) ≥1*10^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.|Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles)|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2704147|NCT01214603|Primary|Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)|Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)]|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2704148|NCT01214434|Secondary|Percent Reduction From Baseline for Oiliness at End of Treatment.|Oiliness scored on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
2704149|NCT01214434|Secondary|Percent Reduction From Baseline for Erythema at End of Treatment.|Erythema scored on scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
2704150|NCT01214434|Secondary|Percent Reduction From Baseline for Crusting at End of Treatment.|Crusting scored on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
2705601|NCT01202253|Secondary|Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants|||Number
2704151|NCT01214434|Secondary|Precent Reduction From Baseline for Scaling at End of Treatment.|Scaling score on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
2704152|NCT01214434|Primary|Number of Participants With Excellent Overall Safety Score at End of Treatment.|The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).|End of treatment|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||participants|||Number
2704153|NCT01214434|Primary|Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).|IGA scored on scale of 0 (clear) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percentage of participants|||Number
2704154|NCT01214395|Secondary|The Number of Patients That Did Not Have a Staphylococcus Aureus Infection||6 months|counted|||participants|||Number
2704155|NCT01214395|Primary|Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.|"Catheter-related infections will be defined according to standard guidelines~Cases with definite and probable infections will be classified as infections."|6 months||||participants|||Number
2704156|NCT01214356|Secondary|Decrease in Estimated Glomerular Filtration Rate (eGFR)|Estimated Glomerular Filtration Rate (eGFR) will be evaluated every 6 months, since changes in eGFR and ACR may occur independently and represent different pathways to the development of renal insufficiency. eGFR will be calculated via the Modification of Diet in Renal Disease (MDRD) equation of 4 variables (Cr level, age, sex, race) per NKF recommendations, with serum creatinine (Cr) measured using the SYNCHRON® System by means of the Jaffe rate method. For the purposes of this study, a decrease in eGFR will serve as a secondary outcome measure.|6 months|||||||
2704157|NCT01214356|Primary|Change in Urinary Albumin:Creatinine Ratio (ACR)|Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).|baseline and 6 months||||ratio||Standard Deviation|Mean
2704158|NCT01214330|Secondary|Patient Attitudes|Results from SoloPap Patient Questionairre regarding patient attitudes.|6 months|||||||
2704159|NCT01214330|Primary|Concordance (Similarity Between Samples) of Pap Smears|Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?|1 year|102 females recruited from an outpatient clinic in a military treatment facility, age >18, without severe hand arthritis|||percentage of participants|||Number
2704160|NCT01214252|Secondary|Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed|Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed|Year 2 to Year 8||||participants|||Number
2704161|NCT01214252|Secondary|Total Unconfirmed Hernia or Hernia Recurrence|"Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage)~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review"|12 Months||||participants|||Number
2704162|NCT01214252|Primary|Confirmed Hernia Recurrence|Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review|12 months||||participants|||Number
2704163|NCT01214239|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
2704164|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
2704165|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
2704166|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
2704167|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
2704168|NCT01214239|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704171|NCT01214239|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2704172|NCT01214239|Secondary|HbA1c Change From Baseline at Week 24 in the Subset of Chinese Patients|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (in the subset of Chinese patients). Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
2704173|NCT01214239|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
2704174|NCT01214239|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
2704175|NCT01214239|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
2704176|NCT01214239|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
2704177|NCT01214200|Secondary|Efficiency of Sleep|Sleep efficiency will be measured by taking the total sleep time by the total time in bed. This is measured as a percentage and compared from baseline to 3 months|Before and after 3 months of therapy|Only 5 participants completed the overnight PSG for this trial.|||percentage of efficiency||Standard Deviation|Mean
2704178|NCT01214200|Secondary|Duration of Sleep|Duration of sleep will be measured using total sleep time. Total sleep time is the overall number of minutes of sleep, this will be compared from baseline to 3 months.|Before and after 3 months of therapy|Only 5 participants completed the overnight PSG for this trial.|||minutes per night||Standard Deviation|Mean
2704179|NCT01214200|Secondary|Sleepiness|Sleepiness will be evaluated by measuring the the baseline and 3 month Epworth Sleepiness Scale. The Epworth Sleepiness Scale is an 8 question survey regarding daytime sleepiness. The higher the score the higher the chance of dozing during the day. Each question is rated on a 0 to 3 scale of chance of dozing or sleeping. 0 would be no chance, 3 would be the highest chance.|Before and after 3 months of therapy|Only 5 participants completed the overnight polysomnography (PSG) for this trial.|||units on a scale||Standard Deviation|Mean
2704180|NCT01214200|Secondary|Dyspnea at Rest and With Exertion|The modifed Borg scale was used to measure dyspnea. The Dyspnea Borg scale measures patients perceived level of dyspnea. The scale ranges from 0 to 10, 0- nothing at all and 10 is maximal.|Before and after 3 months of therapy||||units on a scale||Standard Deviation|Mean
2704181|NCT01214200|Secondary|Exercise Capacity|Exercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months|Before and after 3 months of therapy||||meters||Standard Deviation|Mean
2704182|NCT01214200|Secondary|Maximal Inspiratory Pressure|The Maximal inspiratory pressure (MIP) is the maximum negative pressure that can be generated from one inspiratory effort starting from functional residual capacity (FRC) or residual volume (RV). This was assessed at baseline and after 3 months of therapy.|Before and after 3 months of therapy||||kPa||Inter-Quartile Range|Mean
2704183|NCT01214200|Secondary|Health Status|Health status was assessed by completing different surveys at baseline and after 3 months of therapy. The Calgary Sleep Apnea Quality of Life was administered at baseline and 3 months. It is a 35-item, interview-administered scale, the SAQLI evaluates four domains of quality of life associated with sleep apnea: daily functioning, social interactions, emotional functioning, and symptoms. The SAQLI use a 7-point Likert scale ranging from 1 (maximal impairment) to 7 (no impairment).|Before and after 3 months of therapy||||units on a scale||Inter-Quartile Range|Mean
2704184|NCT01214200|Primary|Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)|Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.|Before and after 3 months of therapy||||mmHg||Inter-Quartile Range|Mean
2704185|NCT01214187|Secondary|St George's Respiratory Questionnaire|St. George's Respiratory Questionnaire (SGRQ) is a validated self-reported instrument. In this instrument, scores range from 0 to 100, with higher scores reflective of worse quality of life.|Baseline to Week 12||||Total Score||Standard Error|Least Squares Mean
2704186|NCT01214187|Secondary|Six Minute Walk Distance|The six minute walk distance is commonly used both in research studies and in clinical practice as a measure of functional capabilities, and changes in six minute walk distance and oxygen use during testing over time often reflect clinically relevant disease progression. We will measure the distance travelled during six minutes (meters) in accordance with published guidelines|Baseline to Week 12||||meters||Standard Error|Least Squares Mean
2704187|NCT01214187|Secondary|Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values|Interstitial changes associated with IPF can worsen diffusing capabilities across the alveolar-capillary membrane. As a result, diffusing capacity of carbon monoxide is an important outcome to assess architectural distortion and resultant decrements in diffusing capabilities|Baseline to Week 12||||% predicted||Standard Error|Least Squares Mean
2704188|NCT01214187|Secondary|Total Lung Capacity % Predicted Values (TLC)|Total lung capacity % predicted values (TLC) is a major clinical determinant of restrictive lung disease in practice, with TLC measurement below the 5th percentile of the predicted value indicative of a restrictive ventilatory defect|Baseline to Week 12||||% Predicted||Standard Error|Least Squares Mean
2704189|NCT01214187|Primary|Serum MMP7 Level|The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression.|Baseline to Week 12|One subject randomized to placebo withdrew consent prior to the MMP7 blood draw at visit 2. This is missing data and the reason why we have n=28 for placebo group.|||ng/ml||Standard Error|Least Squares Mean
2704190|NCT01214174|Primary|Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.|8 days post-treatment||||percentage of patients with ACC clearing||95% Confidence Interval|Number
2704191|NCT01214161|Secondary|Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale|This secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.|during IUD insertion||||units on a 100 mm visual analogue scale||Standard Deviation|Mean
2704192|NCT01214161|Secondary|Adverse Events||During IUD insertion||||participants|||Number
2704193|NCT01214161|Primary|Pain During IUD Insertion at Various Time Points (See Description for Time Points)|Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.|During IUD insertion (see above description for which time points)||||units on a 100 mm visual analogue scale||Standard Deviation|Mean
2704194|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Vz/F,ss excluding subjects with reported emesis|||L||Geometric Coefficient of Variation|Geometric Mean
2704195|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population - Subjects with values for Vz/F,ss|||L||Geometric Coefficient of Variation|Geometric Mean
2704196|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for CL/F,ss excluding subjects with reported emesis|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2704197|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population - Subjects with values for CL/F,ss|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2704198|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cmin,ss excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704199|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cmin,ss|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704200|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for t1/2,ss excluding subjects with reported emesis|||h||Geometric Coefficient of Variation|Geometric Mean
2704201|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population - Subjects with values for t1/2,ss|||h||Geometric Coefficient of Variation|Geometric Mean
2704202|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cavg excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704203|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cavg|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704204|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cpre,ss excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2709280|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients Without Diabetic Disease|Ischemia-driven target lesion revascularization rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2704205|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population - Subjects with values for Cpre,ss|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704206|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population excluding subjects with reported emesis - Subjects with values for PTF excluding subjects with reported emesis|||percent||Geometric Coefficient of Variation|Geometric Mean
2704207|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population - Subjects with values for PTF|||percent||Geometric Coefficient of Variation|Geometric Mean
2704208|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)|tmax = time of maximum observed plasma concentration|27 days|PK population excluding subjects with reported emesis - Subjects with values for t_max excluding subjects with reported emesis|||hours||Full Range|Median
2704209|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)|tmax = time of maximum observed plasma concentration|27 days|PK population - Subjects with values for tmax|||hours||Full Range|Median
2704210|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmax,ss = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cmax,ss excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704211|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)|Cmax = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population - Subjects with values for Cmax,ss|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2704212|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER, excluding subjects with reported emesis|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2704213|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2704214|NCT01214083|Secondary|Liver Function Tests (ALT)||week 0 and week 13||||units/liter||Standard Error|Mean
2704215|NCT01214083|Secondary|Drinks Per Drinking Days||week 1 and week 13||||drinks/drinking day||Standard Error|Mean
2704216|NCT01214083|Secondary|Percentage of Drinking Days|"Percentage of drinking days was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days)."|week 1 and week 13||||percentage of drinking days||Standard Error|Mean
2704217|NCT01214083|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life).|week 1 and week 13||||units on a scale||Standard Error|Mean
2704218|NCT01214083|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness).|week 1 and week 13||||units on a scale||Standard Error|Mean
2704219|NCT01214083|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems).|week 1 and week 13||||units on a scale||Standard Error|Mean
2704220|NCT01214083|Secondary|Penn Alcohol Craving Scale (PACS)|The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving).|week 1 and week 13||||units on a scale||Standard Error|Mean
2704221|NCT01214083|Secondary|Liver Function Tests (AST)||week 0 and week 13||||units/liter||Standard Error|Mean
2704222|NCT01214083|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking)."|week 1 and week 13||||percentage of heavy drinking days||Standard Error|Mean
2704223|NCT01214044|Secondary|Change in Phase Angle Difference (PAD)|The PAD is the time interval (number of hours) between the Dim Light Melatonin Onset (DLMO) and the average midpoint of sleep during the prior week. Larger PADs indicate a longer time interval between the DLMO and midpoint of sleep. A negative change in PAD value indicates a shortening of the time interval from Study Visit 3 to Study Visit 11.|8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)|Of the 10 subjects who completed all study procedures, adequate PAD data from both study visits 3 and 11 (derived from dim light melatonin onset and sleep diary) were available for 7 subjects.|||hours||Standard Deviation|Mean
2704245|NCT01213576|Primary|Number of Participants Achieving Microfilarial Clearance|Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.|12 months|Number of participants with non detectable microfilaria at follow up|||participants|||Number
2704224|NCT01214044|Secondary|Change in Beck Depression Inventory II (BDI-II) Scores|The BDI-II is the total score on the 21-question Beck Depression Inventory II questionnaire. Scores range from 0 to 63 with higher scores indicating worse symptoms of depression.|8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)|Of the 10 subjects who completed all study procedures, Beck Depression Inventory-II data from both study visits 3 and 11 were available for 7 subjects.|||units on scale (scores)||Standard Deviation|Mean
2704225|NCT01214044|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|The HAM-D is the total score on the 21-question Hamilton Depression Rating Scale. Scores range from 0 to 53 with higher scores indicating worse symptoms of depression.|8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)|Of the 10 subjects who completed all study procedures, adequate Hamilton Depression Rating Scale data from both study visits 3 and 11 were available for 7 subjects.|||units on scale (scores)||Standard Deviation|Mean
2704226|NCT01214044|Primary|Change in Dim Light Melatonin Onset|"The Dim Light Melatonin Onset (DLMO) is the time of the onset of melatonin secretion under dim light conditions using the equivalent thresholds of 10 pg/ml in plasma and 3 pg/ml in saliva. It is a marker of biological time. Data are provided in decimal and military time (e.g., 9:30 pm equals 21.50).~This measure is used to determine if there was a change in the time of the dim light melatonin onset (DLMO) before treatment with escitalopram (at Study Visit 3) and after treatment with escitalopram (at Study Visit 11)."|8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)|Of the 10 subjects who completed all study procedures, adequate dim light melatonin data from both study visits 3 and 11 were available for 9 subjects.|||decimal military time (hours)||Standard Deviation|Mean
2704227|NCT01213966|Primary|Derived Parasite Reduction Rate at 24 Hours (PPR24)|"PRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point.~The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed."|24 hours after study drug administration||||Log10 parasites/24h||Full Range|Median
2704228|NCT01213836|Secondary|Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.|The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively.|End of Period 1, end of Period 2|21 patients for the FAS were analysed. This outcome measure was introduced as a protocol amendment after study start and plasma concentration was not measured in all patients. FAS is all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.|||Ratio||Standard Deviation|Mean
2704229|NCT01213836|Secondary|Number of Dropouts.|The number of patients who dropped out was counted.|Period 1 and Period 2|The Safety analysis set was used, that is all patients who received at least one dose of study medication and for whom any post-dose safety data are available were included in the safety set.|||participants|||Number
2704230|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label|"Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie).~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.|||units on a scale||Standard Deviation|Mean
2704231|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label|"The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres.~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.|||units on a scale||Standard Deviation|Mean
2704232|NCT01213836|Secondary|Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving|International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|Per Protocol (PPS), subset of the FAS consisting of patients who fulfilled all of inclusion but none of exclusion criteria, complied with study medication dosing, did not violate any of the restrictions and completed the study without protocol violation.|||Units on a scale||Standard Deviation|Mean
2704244|NCT01213576|Secondary|Number of Participants With Microfilarial Clearance at 24 Months of Follow up|Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample|24 months|Intention to treat, with last result carried forward in the case of missing visit|||participants|||Number
2704233|NCT01213836|Secondary|Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)|"TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction.~There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group."|Before taking study drug, end of Period 1 and end of Period 2|Full Analysis Set (FAS)used for efficacy analysis included all patients who in both study periods, received at least 1 dose of investigational product and for whom post-dose efficacy data was available.|||units on a scale||Standard Deviation|Mean
2704234|NCT01213836|Primary|Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)|Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The per protocol set (PPS) is a subset of the FAS consisting of patients who fulfilled all inclusion criteria but none of the exclusion criteria, complied with study medication dosing scheme, did not violate any of the study restrictions and completed the study without protocol violation.|||standardised units||Standard Deviation|Mean
2704235|NCT01213823|Primary|Number of Any Severe Hepatic Injury Cases and Matched Controls|Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.|01 June 2006 to 30 June 2008 (up to 25 Months)|Acute-care participants, with at least 1 dose of echinocandin antifungal therapy and a primary or secondary International Classification of Diseases 9 (ICD-9).|||Participants|||Number
2704236|NCT01213706|Primary|Airway Blood Flow Response to Albuterol|Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.|Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA|controls n =15, smokers N=15 , asthma N=15|||μl/min/ml||Standard Error|Mean
2704237|NCT01213589|Secondary|Clinical Success|"Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:~Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)"|through 36 months||||participants|||Number
2704238|NCT01213589|Secondary|Freedom From Disease-, Procedure-, or Device-related Severe Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.~Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications"|through 36 months||||Percentage Event Free|||Number
2704239|NCT01213589|Secondary|Freedom From Disease-, Procedure- or Device-related Major Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.~Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group."|through 36 months||||Percentage Event Free|||Number
2704240|NCT01213589|Secondary|Freedom of Re-intervention|Kaplan-Meier estimate of freedom from secondary procedures by clinical group.|30 days or at discharge, 3/6/12/24/36 months||||Percentage Event Free|||Number
2704241|NCT01213589|Secondary|Efficacy/Performance|- Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements|30 days or at discharge, 3/6/12/24/36 months||||participants|||Number
2704242|NCT01213589|Secondary|Safety|"All causes mortality~Disease-, procedure- or device-related mortality"|30 days or at discharge, 3/6/12/24/36 months||||participants|||Number
2704243|NCT01213589|Primary|Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure|Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.|12 months post-procedure||||participants|||Number
2709281|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients With Diabetic Disease.|Ischemia-driven target lesion revascularization rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2704246|NCT01213472|Secondary|Cell Mediated Immune Response for Anti-NY-ESO-1 Antibodies (T-cell)|Cellular (T-cell) response was not analysed as data only available for few patients.|Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)|As study development was stopped earlier, and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, Cellular (T-cell) response was not analysed as data only available for few patients.||||||
2704247|NCT01213472|Secondary|Humoral Response for Anti NY-ESO-1 Antibodies|Anti NY-ESO-1 antibody response was defined as: For initially seronegative patients: post-vaccination antibody concentration greater than or equal to (≥) 179 EU/mL and for intially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.|At 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704248|NCT01213472|Secondary|Anti NY-ESO-1 Antibody Concentrations|Anti-NY-ESO-1 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2704249|NCT01213472|Secondary|Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival|Summary of deaths included death, autopsy performed and cause of death. Progression of the tumor was recorded in the clinical assessments. Death due to progressive disease was to be recorded on a specific form in the case report form but not as a serious adverse event (SAE). However, if the investigator considered that there was a causal relationship between the administration of the treatment or protocol design/procedures and the disease progression, then this must be reported as an SAE.|During the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.]|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704250|NCT01213472|Secondary|Number of Patients With Progression-free Survival Events|Progression-free survival was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death (for whatever reason), whichever came first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. PFS events included progressive disease (PD), death in absence of PD and events (Any event which was part of the natural course of the disease under study, was captured as an efficacy measure. Therefore it did not need to be reported as an SAE).|From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704251|NCT01213472|Secondary|The Duration of Response for Patients With CR, PR or Stable Disease (SD) Status|The duration of response was measured from the time when the measurement criteria for CR/PR (whichever was recorded first) or SD evaluation were met until the first date that first PD or death was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum of LD of target lesions recorded previously but not necessarily at baseline (The minimal time interval required between two measurements for determination of SD was at least 16 weeks.). The analysis was not performed as initially planned.|From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)|As study development was stopped earlier and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, analyses on Duration of Response for Patients With CR, PR or SD Status, as required in this outcome, were not performed.||||||
2704252|NCT01213472|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from first treatment until death. Patients alive at the time of analysis were censored at the time of last visit/contact.|From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Months||95% Confidence Interval|Median
2704253|NCT01213472|Secondary|Progression-free Survival (PFS) Rate|Progression-free survival (PFS) was defined as the time from first treatment to either the date of first disease progression (PD) or the date of death (for whatever reason), whichever came first. Patients alive and without disease progression were censored at the date of the last visit/contact.|From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Months||95% Confidence Interval|Median
2704254|NCT01213472|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) was defined as the time from first treatment until the date of the last treatment administration, for patients who discontinued the treatment prematurely, regardless of the reason for study treatment discontinuation. Patients who completed their full treatment phase or who were still on treatment at the time of analysis were censored on their last study treatment administration date..|From first treatment administration (i.e. at Week 0) until the last treatment administration (i.e. at Month 48)|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Months||95% Confidence Interval|Median
2704255|NCT01213472|Secondary|Number of Patients With Serious Adverse Events (SAEs) That Are Causally Related to Treatment Administration by Maximum Grade|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs will be considered as medically significant and will therefore be notified as SAE. No serious adverse events were reported during the study period that are causally related to treatment administration by maximum grade.|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704256|NCT01213472|Secondary|Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs were considered as medically significant and were therefore notified as SAE.|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704257|NCT01213472|Secondary|Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade|An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medical product, whether or not considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack efficacy), abuse or misuse.|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704258|NCT01213472|Secondary|Number of Patients With Adverse Events (AEs) by Maximum Grade|An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medical product, whether or not considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack efficacy), abuse or misuse.|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704259|NCT01213472|Secondary|Number of Patients With Objective Clinical Response (CR or PR) in the Population of Patients Who Present the Predictive Melanoma Antigen A3 (MAGE-A3) Gene Signature|Following MAGE3-AS15-NSC-003 (ADJ) (NCT00480025) study (A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive Non-Small Cell Lung Cancer) showed the absence of treatment effect in any of the primary, secondary, or exploratory analyses, clinical activity was not reported within the population of patients who present the predictive MAGE-A3 gene signature, in that study.|After 12, 22, 31 and 54 weeks of treatment.|As study development was stopped earlier and decision was taken not to perform further testing on biological samples already collected, except if a scientific rationale remained relevant, analyses for patients who presented MAGE-A3 gene signature as required in this outcome, were not performed.||||||
2704260|NCT01213472|Secondary|Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria|"Patients with Slow Progressive Disease (SPD) status met the following criteria: patient's Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1, patient's lactate dehydrogenase (LDH) value was not greater than twice the normal upper limit, there was no appearance of visceral metastases other than in the lung, patients did not meet any of the criteria for permanent stopping of study treatment. Mixed response (MxR) criteria was defined as follows: at least 30% decrease in the longest diameter (LD) occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise stable disease (SD) or progressive disease (PD) status of LD of target lesions and without the appearance of one or more new lesions were classified as SD with target lesion regression or PD with target lesion regression. The appearance of new lesions in otherwise partial response (PR) status of the LD of target lesions were classified as PR with new lesion."|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704261|NCT01213472|Primary|Number of Patients With the Best Overall Response in the Overall Population|Best response was recorded from the start of treatment until disease progression. Response assessment was essentially based on a set of measurable lesions (target lesions [TL]), and any other lesions (non-target lesions [NTL]), both identified at baseline. Complete Response (CR)=disappearance of all TL or NTL; Partial Response (PR) = at least 30 percent (%) decrease in the sum of the longest diameter(LD) of TL compared to baseline, stable disease (SD) = neither sufficient shrinkage to qualify PR nor sufficient increase to qualify for Progressive disease (PD) compared with baseline; PD = at least 20% increase in the sum of LD of TL compared with baseline, or the appearance of one or more new lesions, or both of these, and/or unequivocal progression of existing NTL; NE =non-evaluable; Clinical response: any CR or PR best overall response; Disease control: any CR, PR, SD or SD/PR best overall response.|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704262|NCT01213472|Primary|Number of Patients With Severe Toxicities During the Follow-up Period|Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy in order to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.|During the one year follow-up period (i.e. from Month 49 until Month 61)|The analysis was to be performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the ASCI treatment. All active follow-up visits and procedures were stopped, hence this follow-up analysis was not performed as initially planned.||||||
2704263|NCT01213472|Primary|Number of Patients With Severe Toxicities During the Study Treatment Period|Severe toxicity was defined, according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0), as 1)an Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly related Grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) should persist for 48 hours despite therapy to be taken into account and as 2)an ASCI related or possibly related Grade 2 or higher allergic reaction occurring within 24 hours of the dose administration.|During the study treatment period (maximum duration = 49 months).|The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.|||Participants|||Count of Participants
2704264|NCT01213329|Secondary|Donor Specific Hypo-reactivity.|"Identify, by studying recipients for development of donor specific hypo-reactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized.~Unfortunately this secondary outcome was not studied because of lost samples that did not allowed us further analysis to identify patients with donor specific hypo reactivity."|Pre-transplant, 6mo & 12mo post-transplant|no one were analyzed due to loss of blood samples||||||
2704265|NCT01213329|Primary|The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.|Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months & 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells & NK cells, naive & memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). Unfortunately blood samples were lost due to malfunction of liquid nitrogen tank that stopped working during a power loss.|Pre-transplant, 6months & 12 months post-transplant|samples from 26 recipient/donor pairs were collected = 52 collected but no analysis was performed because samples were lost.||||||
2704266|NCT01213316|Secondary|Percentage of Aging Participants Taking Concomitant Medications at Baseline|The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Percentage of participants|||Number
2704267|NCT01213316|Secondary|Percentage of Aging Participants With Concomitant Diseases at Baseline|The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Percentage of participants|||Number
2704268|NCT01213316|Secondary|Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.|||Percentage risk||Standard Deviation|Mean
2704269|NCT01213316|Secondary|Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.|||Percentage risk||Standard Deviation|Mean
2704292|NCT01213173|Secondary|The Change From Baseline in Triglycerides|Difference of change from baseline in TG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.|||mmol/L||95% Confidence Interval|Least Squares Mean
2704270|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||CD4+ T-cells/µL||Standard Deviation|Mean
2704271|NCT01213316|Secondary|HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Log10 Copies/mL||Standard Deviation|Mean
2704272|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.|||CD4+ T-cells/µL||Standard Deviation|Mean
2704273|NCT01213316|Secondary|HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.|||Log10 Copies/mL||Standard Deviation|Mean
2704274|NCT01213316|Secondary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.|||Percentage of participants||95% Confidence Interval|Number
2704275|NCT01213316|Primary|Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Percentage of participants||95% Confidence Interval|Number
2704276|NCT01213316|Primary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included all participants who received at least one dose of raltegravir during the observation period.|||Percentage of participants||95% Confidence Interval|Number
2704277|NCT01213264|Primary|Type of NMB-reversal Agent Administered to Study Participants|For all participants who received an NMB-reversal agent, the specific agent administered was recorded.|At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)|All study participants who received an NMBA or NMB-reversal agent|||participants|||Number
2704278|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Recovery Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Recovery Room. The time of dismissal from the Recovery Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical and recovery period (up to approximately 170 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.|||minutes||Standard Deviation|Mean
2704279|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Operating Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Operating Room. The time of dismissal from the Operating Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical period (up to approximately 24 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.|||minutes||Standard Deviation|Mean
2704280|NCT01213264|Primary|Type of Surgical Procedure Performed in Study Participants|The type of surgical procedure performed in each study participant was recorded.|Day of surgery (Day 1)|All study participants who received a neuromuscular blocking agent (NMBA) or NMB-reversal agent|||participants|||Number
2704281|NCT01213264|Primary|Time From End of Surgery (End of Last Stitch) to Extubation|"This measure is the duration from the last surgical wound stitch to the post-surgical extubation of the participant. The time of extubation was to be recorded for each participant, irrespective of the criteria used to make the decision to extubate the participant. Data are presented by TOF-ratio <0.9 and ≥0.9 at extubation. The TOF-ratio is a measure of neuromuscular function ranging from 0.0 to 1.0. The greater the T4/T1 ratio the greater~the recovery from neuromuscular blockade. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications."|From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)|Evaluable participants with TOF-ratio measurement at time of extubation and available procedure duration data. Three sugammadex participants with duration from end of surgery to extubation >1 hour were excluded from analysis; delay of extubation was considered due to factors unrelated to administration of sugammadex.|||minutes||Standard Deviation|Mean
2704293|NCT01213173|Secondary|The Change From Baseline in Fasting Plasma Glucose|Difference of change from baseline in FPG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.|||mmol/L||95% Confidence Interval|Least Squares Mean
2704282|NCT01213264|Primary|Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation|Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.|At extubation (approximately <1 to 125 minutes after end of surgery)|Evaluable participants with TOF-ratio measurement at time of extubation|||participants|||Number
2704283|NCT01213251|Secondary|Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.|"Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.~Variables resulting in statistical significant (p<0.05) are reported."|Baseline - 18 Month Follow Up Visit|All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.|||regression coefficient||Standard Error|Mean
2704284|NCT01213251|Secondary|Incidence of Sudden Cardiac Death and Total Mortality|"Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.~Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control."|18 Months post-randomization|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.|||percentage of subjects at risk||95% Confidence Interval|Number
2704285|NCT01213251|Secondary|Change in Quality of Life|"Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.~Change is defined as month 18 minus baseline.~Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control."|Baseline - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.|||units on a scale||95% Confidence Interval|Mean
2704286|NCT01213251|Secondary|Change in 6-minute Walk Test Distance|"Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.~Change is defined as month 18 minus baseline.~Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control."|1 Month - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.|||meters||95% Confidence Interval|Mean
2704287|NCT01213251|Secondary|Change in New York Heart Association (NYHA) Functional Class|"The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.~NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as Improved. Similarly for Worsened (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as No Change.~Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.|||participants|||Number
2704288|NCT01213251|Secondary|Frequency of Hospitalization for Cardiovascular Events|Number of hospitalizations related to cardiovascular events.|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.|||participants|||Number
2704289|NCT01213251|Secondary|Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events|Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.|18 months post-implant|Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.|||survival probability||95% Confidence Interval|Number
2704290|NCT01213251|Primary|Change in Left Ventricular End Diastolic Volume (LVEDV)|"Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.~Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.|||mL||95% Confidence Interval|Mean
2704291|NCT01213199|Primary|Global Scarring Severity|"Grade Level:~Macular disease~Mild disease~Moderate disease~Severe disease"|Week 24|The analysis population includes 18 subjects whose data were available at this time frame (week 24).|||units on a scale||Standard Deviation|Mean
2704294|NCT01213173|Secondary|The Change From Baseline in Total Cholesterol|Difference of change from baseline in TC after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.|||mmol/L||95% Confidence Interval|Least Squares Mean
2704295|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Attacks per week||95% Confidence Interval|Least Squares Mean
2704296|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Attacks per week||95% Confidence Interval|Least Squares Mean
2704297|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 8 weeks treatment.~Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||mm*min||95% Confidence Interval|Least Squares Mean
2704298|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 2 weeks treatment.~Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||mm*min||95% Confidence Interval|Least Squares Mean
2704299|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Participants|||Number
2704300|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Participants|||Number
2704301|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||95% Confidence Interval|Least Squares Mean
2704302|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate Between Two Groups|Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||Standard Deviation|Mean
2704303|NCT01213173|Secondary|The Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||95% Confidence Interval|Least Squares Mean
2704304|NCT01213173|Primary|The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)|Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||Standard Deviation|Mean
2704305|NCT01213082|Secondary|Number of Anti-VEGF Injections Administered|efficacy measure|Month 24||||number of anti-VEGF injections per eye||Standard Deviation|Mean
2704306|NCT01213082|Primary|Percent of Eyes With Severe Ocular Adverse|vision loss of 3 or more lines associated with radiation retinopathy or papillopathy|Month 24||||percentage of participants|||Number
2704307|NCT01213043|Primary|Number of Treatment-Emergent Pulmonary Exacerbations|Total number of treatment-emergent pulmonary exacerbations.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||Events|||Number
2704308|NCT01213043|Primary|Number of Drug-related TEAEs|Total number of drug-related TEAEs reported|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||Events|||Number
2704309|NCT01213043|Primary|Number of TEAEs|Total number of TEAEs reported.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||Events|||Number
2704310|NCT01213043|Secondary|Mean Trough|The average trough concentration at steady-state, calculated as the mean value using the four Trough measurements obtained at Weeks 6, 7, 8 and at 7 days (168 hours) post infusion at Week 8 for the first treatment period or prior to the start of the infusions at Weeks 16, 17, 18, and at 7 days (168 hours) post infusion at Week 18 for the second treatment period.|Single measurment immediately prior to infusion at Weeks 6, 7, 8, 9 and Weeks 16, 17, 18, 19|PK Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.|||μM||Standard Deviation|Mean
2704311|NCT01213043|Primary|Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s)|Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
2704312|NCT01213043|Primary|Subjects With Treatment-Emergent Pulmonary Exacerbation(s)|Number of subjects with at least one treatment-emergent pulmonary exacerbation|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
2704313|NCT01213043|Primary|Subjects Withdrawn Due to an AE(s)|Number of subjects who were withdrawn from the study due to at least one AE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
2704314|NCT01213043|Primary|Subjects With Treatment-Emergent Serious Adverse Events (SAEs)|Number of subjects who experienced at least one treatment-emergent SAE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
2704315|NCT01213043|Primary|Subjects With Drug-Related TEAE(s)|"Number of subjects with at least one TEAE that was determined by the Investigator to be either possibly related or related to the investigational product (i.e., Prolastin-C)."|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
2704316|NCT01213043|Secondary|AUC0-7days|Area Under the Alpha-1 PI Concentration-Time Curve from Day 0 to Day 7|Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose|Pharmacokinetic (PK) Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.|||h*mg/mL||Standard Deviation|Mean
2704317|NCT01213043|Primary|Subjects With Treatment-Emergent Adverse Events (TEAEs)|Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
2704318|NCT01212991|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum duration of 6.5 years that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)|The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2704319|NCT01212991|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)|The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2704320|NCT01212991|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)|The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2704533|NCT01211730|Primary|Rejection of Liver Transplant|Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications|within 1 year of transplantation|Patients undergoing liver transplant|||participants|||Number
2704321|NCT01212991|Secondary|Best Overall Soft Tissue Response|The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.|During study period (up to 3 years)|Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.|||Percentage of participants|||Number
2704322|NCT01212991|Secondary|Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%|PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.|During study period (up to 3 years)|Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.|||Percentage of Participants||95% Confidence Interval|Number
2704323|NCT01212991|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomized.|||months||95% Confidence Interval|Median
2704324|NCT01212991|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.|||months||95% Confidence Interval|Median
2704325|NCT01212991|Secondary|Time to First Skeletal-related Event|Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.|||months||95% Confidence Interval|Median
2704326|NCT01212991|Primary|Radiographic Progression-free Survival (rPFS)|Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.|During study period (up to 20 months)|Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.|||months||95% Confidence Interval|Median
2704327|NCT01212991|Primary|Overall Survival|Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.|||months||95% Confidence Interval|Median
2704328|NCT01212952|Secondary|Number of Participants With Adverse Events|Reported in Adverse Events section of the results|2.5 years|All participants combined in this analysis due to small numbers in Phase I portion.|||Participants|||Count of Participants
2704329|NCT01212952|Secondary|Progression Free Survival|The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h)|2.5 years||||months||95% Confidence Interval|Median
2704534|NCT01211665|Primary|Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent||Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
2704330|NCT01212952|Primary|Number of Participants With a Hematologic Response (PR, VGPR, or CR)|The number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011). sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h. PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h. MR: NA. SD: Not meeting criteria for CR, VGPR, PR, or progressive disease. PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h)|2.5 years||||Participants|||Count of Participants
2704331|NCT01212952|Primary|Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.|MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).|2.5 years|The first 9 patients accrued(All Phase 1 patients) were evaluated for the MTD.|||Participants|||Count of Participants
2704332|NCT01212900|Primary|Change in Mean of Wall Volume of Internal Carotid Arteries|Wall volume of internal carotid arteries was measured using magnetic resonance imaging. Participants will undergo 2D and 3D carotid MRI using a 3 Tesla scanner and surface carotid coils. Participants with mild or no atherosclerosis, defined as the lowest tertile of wall volume, will have statin therapy adjusted to a target range of 100-130 mg/dL. Participants in the middle tertile will receive statin therapy adjusted to achieve a target LDL 70-100 mg/dL. Participants with the most severe atherosclerosis will receive statin therapy to an LDL target between 40 and 70 mg/dL. Participants in the Standard arm will have lipid sub-fraction targets determined according to estimated 10 year cardiovascular risk, as per standard NCEP guidelines.|24 months|The analyses included only those subjects who were assigned standardized statin doses based on imaging of carotids at baseline based on NCEP ATP IIIR guidelines.|||Other - mm^3 ( cubic millimeter )||95% Confidence Interval|Mean
2704333|NCT01212874|Secondary|Title: Systolic Hypertension|Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.|||mmHg*min / prebypass hour||95% Confidence Interval|Median
2704334|NCT01212874|Primary|Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour|Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.|||mmHg*min/prebypass hour||95% Confidence Interval|Median
2704335|NCT01212770|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.|Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg BID|Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||participants|||Number
2704336|NCT01212770|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.|Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population = participants who received at least one dose of IP;1 participant randomized to 30 mg APR who received PBO in error is counted in the PBO group;1 participant randomized to PBO who received 30 mg APR in error is counted in the 30 mg group;1 participant randomized to PBO who received 20 mg APR in error is counted in the 20 mg group|||participants|||Number
2704344|NCT01212770|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704337|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704338|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704339|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704340|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704341|NCT01212770|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants|||Number
2704342|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704343|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704345|NCT01212770|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: •28 tender joint count •28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; •C-reactive protein (CRP) •Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704346|NCT01212770|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: •28 tender joint count (TJC), •28 swollen joint count (SJC), •Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; •Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704347|NCT01212770|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704348|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704349|NCT01212770|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
2704350|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52|The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with Baseline Psoriasis Body Surface Area ≥ 3% and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
2704351|NCT01212770|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704352|NCT01212770|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704353|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704354|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704355|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704356|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704357|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704358|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704359|NCT01212770|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704360|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704361|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704362|NCT01212770|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704363|NCT01212770|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704364|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704365|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704366|NCT01212770|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704450|NCT01212744|Secondary|Plasma Concentrations of rAvPAL-PEG (BMN 165)|Measurements taken pre-dose|Baseline, Week 8, Week 13|The PK population will consist of all subjects who received any amount of study drug and have post-treatment plasma BMN 165 concentration measurements.|||ng/mL||Standard Deviation|Mean
2704367|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704368|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704369|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704370|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704371|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704372|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704373|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704374|NCT01212770|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
2704375|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24|The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 24|Full analysis set; participants with baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704376|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704377|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704378|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704379|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704380|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704381|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704451|NCT01212744|Secondary|Percentage of Participants With PAL IgG Antibody Percentage of Participants With Positive PAL IgG|Antibody against phenylalanine ammonia lyase (PAL)|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704382|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704383|NCT01212770|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
2704384|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16|The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 16|Full analysis set; participants with a baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704385|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704386|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704387|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704388|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704535|NCT01211665|Primary|Time Course Change in Clinical Laboratory Values|Clinical laboratory values included chemokines, cytokines, C-reactive protein (CRP), John Cunningham (JC) virus load, and cell count in cerebrospinal fluid.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
2704389|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2704390|NCT01212770|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704391|NCT01212757|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period|"A treatment emergent adverse event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Constituted an important medical event"|Week 0 to week 260; overall median duration of exposure to apremilast 20 mg and 30 mg BID was 198 weeks|Apremilast subjects as treated who received at least 1 dose of apremilast at any time during the study at week 0, week 16 or week 24.|||participants|||Number
2704392|NCT01212757|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Placebo-Controlled Phase|"A treatment emergent adverse event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Constituted an important medical event"|Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population included all participants who were randomized and received at least one dose of IP.|||Participants|||Number
2704393|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704394|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704395|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704396|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704397|NCT01212757|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants|||Number
2704398|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704399|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704400|NCT01212757|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704401|NCT01212757|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704402|NCT01212757|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704403|NCT01212757|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704404|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704405|NCT01212757|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
2704406|NCT01212757|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704407|NCT01212757|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704408|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2704409|NCT01212757|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2704410|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704452|NCT01212744|Secondary|Study Drug Related Adverse Events|Safety will be evaluated on the incidence of AEs and clinically significant changes in vital signs as well as clinical labs and ECG. Please refer to AE section below for comprehensive listing of all adverse events recorded during study.|Weekly|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Participants|||Count of Participants
2704411|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704412|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704413|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704414|NCT01212757|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704415|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704416|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704417|NCT01212757|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2725219|NCT01059682|Primary|Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.||24 months||||Percent Change Atheroma Volume||Standard Deviation|Mean
2704418|NCT01212757|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704419|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704420|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704421|NCT01212757|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704422|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704423|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704424|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704453|NCT01212744|Primary|Blood Phenylalanine Concentration|Plasma Phe|Baseline, Week 16|The efficacy population will consist of all subjects who received any amount of study drug and have post-treatment blood Phe concentration measurements.|||umol/L||Standard Deviation|Mean
2705602|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Colonization Index||Baseline|Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.||||||
2704425|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704426|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704427|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704428|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704429|NCT01212757|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
2704430|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704431|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704454|NCT01212627|Secondary|Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.|the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin|1 year|||||||
2709307|NCT01178268|Secondary|Procedure Time|This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.||||Minutes||Standard Deviation|Median
2704432|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704433|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: - 28 tender joint count - 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; - C-reactive protein (CRP) - Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704434|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: - 28 tender joint count (TJC), - 28 swollen joint count (SJC), - Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; - Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704435|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704436|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704437|NCT01212757|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
2704438|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: - 78 tender joint count, - 76 swollen joint count, - Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; - Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704439|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2704455|NCT01212627|Primary|Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab|"the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin~Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day"|1 year||||mg/day|||Number
2704440|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2704441|NCT01212757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2704442|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2704443|NCT01212757|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an ACR20 response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2704444|NCT01212744|Secondary|Percentage of Participants With PAL-PEG-IgE Antibody Positivity|Antibodies against phenylalanine ammonia lyase (PAL)-polyethylene glycol (PEG) of the IgE isotype|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704445|NCT01212744|Secondary|Percentage of Participants With PAL-IgE Antibody Positivity|Antibodies against phenylalanine ammonia lyase (PAL) of the IgE isotype|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704446|NCT01212744|Secondary|Percentage of Participants With Neutralizing Antibody Positivity|Antibody positivity over time|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704447|NCT01212744|Secondary|Percentage of Participants With PEG-IgM Antibody Positivity|Antibodies against polyethylene glycol (PEG) of the IgM isotype|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704448|NCT01212744|Secondary|Percentage of Participants With PAL-IgM Antibody Positivity|Antibodies against phenylalanine ammonia lyase (PAL) of the IgM isotype|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704449|NCT01212744|Secondary|Percentage of Participants With PEG-IgG Antibody Positivity|Antibodies against polyethylene glycol (PEG) of the IgG isotype|Baseline, Week 16|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, chest x-ray, antibodies, and physical examinations).|||Percentage|||Number
2704456|NCT01212588|Secondary|Symptom Change - SCL-90-R|The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.|21 days after discontinuation of study medication (Visit 6)||||Scores on a scale||Standard Deviation|Mean
2704457|NCT01212588|Secondary|Symptom Change - SCL-90-R|The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.|7 days of study medication (Visit 4)||||Scores on a scale||Standard Deviation|Mean
2704458|NCT01212588|Secondary|Symptom Change - BPDSI Subscales|Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.|21 days after discontinuation of study medication (Visit 6)||||Scores on a scale||Standard Deviation|Mean
2704459|NCT01212588|Secondary|Symptom Change - BPDSI Subscales|Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.|7 days of study medication (Visit 4)||||Scores on a scale||Standard Deviation|Mean
2704460|NCT01212588|Secondary|Symptom Change - CGI-I|The Clinical Global Impressions Improvement (CGI-I) scale is used to assess the clinical change as compared to symptoms at baseline using a 7-point Likert scale, ranging from very much improved (1) to very much worse (7), with a higher score indicating more severity.|7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)|The CGI-I is measured at visits after baseline, there was 1 subject taking Placebo who discontinued prior to Visit 4 and therefore was not included in analysis.|||Scores on a scale||Standard Deviation|Mean
2704461|NCT01212588|Secondary|Symptom Change - CGI-S|The Clinical Global Impressions Severity Scale (CGI-S) is used for repeated evaluations of global psychopathology. The CGI-S scale is widely used in schizophrenia research and is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill), with a higher score indicating more severity.|Baseline, 7 days of study medication (Visit 4), 21 days after discontinuation of study medication (Visit 6)||||Scores on a scale||Standard Deviation|Mean
2704462|NCT01212588|Secondary|Metacognitive Capacity|The Indiana Psychiatric Illness Interview (IPII) is a semi-structured interview developed to assess illness narratives. Responses are audio taped and later transcribed. It is scored using the Metacognition Assessment Scale- Abbreviated (MAS-A), which has four domains of metacognition: i) Self-Reflectivity ranging from 0-9; ii) Understanding the Mind of Other ranging from 0-7; iii) Decentration ranging from 0-3; and iv) Mastery ranging from 0-9. Lower scores indicate metacognitive deficits, higher scores indicate more integrated and nuanced metacognition. MAS-A total score is the sum of the scores on each of the domains of metacognition, ranging from 0-28, with a lower score indicating metacognitive deficits and a higher score indicating more integrated and nuanced metacognition.|Baseline, 21 days after discontinuation of study medication|The IPII assessment was added to the study midway through the study therefore, the first 10 subjects did not have this assessments.|||Scores on a scale||Standard Deviation|Mean
2704463|NCT01212588|Secondary|Symptom Change - SCL-90-R|The Symptom Checklist-90-Revised (SCL-90-R) instrument helps evaluate a broad range of psychological problems and symptoms of psychopathology. The instrument is also useful in measuring patient progress or treatment outcomes. The SCL-90-R contains 90 items on a 5-point rating scale, with a higher score indicating more severity. The items are categorized into 12 domains (9 scores along primary symptom dimensions and 3 scores among global distress indices). A t-score for each domain is then obtained by norming by sex and ranges between 19-81, with a higher score indicating more severity.|Baseline (Visit 2)||||Scores on a scale||Standard Deviation|Mean
2704464|NCT01212588|Secondary|Symptom Change - Borderline Checklist|The Borderline Personality Checklist (BPD Checklist) is a 47-item DSM-IV based self-report questionnaire, designed to assess the experienced burden of specific BPD symptoms during the previous week. The BPD Checklist measures symptoms with scores ranging from 1-5, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 47-235, with a higher score indicating more severity.|Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)||||Scores on a scale||Standard Deviation|Mean
2704465|NCT01212588|Secondary|Symptom Change - BPRS|The Brief Psychiatric Rating Scale (BPRS) is an 19-item scale measuring positive symptoms, general psychopathology and affective symptoms during the last 7 days. The BPRS measures symptoms with scores ranging from 0-7, with a higher score indicating more severity. A total score is then calculated by adding all the item scores, ranging from 0-133, with a higher score indicating more severity.|Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)||||Scores on a scale||Standard Deviation|Mean
2704526|NCT01211756|Secondary|Global Assessment of Functioning (GAF)|The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704466|NCT01212588|Secondary|Symptom Change - BPDSI Subscales|Borderline Personality Disorder Severity Index (BPDSI) symptom domain subscales scores. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms.|Baseline (Visit 2)||||Scores on a scale||Standard Deviation|Mean
2704467|NCT01212588|Primary|Levels of Cortisol|To assess cortisol levels as a potential biomarker of hypothalamic-pituitary-adrenal (HPA)-axis engagement|Baseline (Visit 2), 7 days of study medication (Visit 4), 7 days after discontinuation of study medication (Visit 5), 21 days after discontinuation of study medication (Visit 6)||||mcg/dL||Standard Deviation|Mean
2704468|NCT01212588|Primary|Number of Participants With Possibly and Probably Related Adverse Events|To determine the safety and tolerability of mifepristone according to subject report of possibly and probably related adverse events (AEs). AEs were evaluated by study physicians at each visit and each reported AE was evaluated for relatedness (unrelated, possibly related, or probably related) to the study drug/procedure.|Baseline to 21 days after discontinuation of study medication||||Participants|||Count of Participants
2704469|NCT01212588|Primary|Durable Symptom Change|To evaluate whether seven days of mifepristone treatment will result in a durable change in symptoms persisting after active treatment discontinuation, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.|7 days of study medication to 21 days after discontinuation of study medication||||Scores on a scale||Standard Deviation|Mean
2704470|NCT01212588|Primary|Rapid Symptom Change|To evaluate whether mifepristone will produce rapid symptom change after seven days of active treatment, as measured by Borderline Personality Disorder Severity Index (BPDSI) total score. The BPDSI is a semi-structured clinical interview assessing the frequency and severity of manifestations of Borderline Personality Disorder (BPD) during a circumscribed period of the previous 7 days. The BPDSI measures 9 symptoms associated with BPD on a Likert scale ranging from 0-7 (0 = never; 7 = daily). Each symptom measure produces a mean score ranging from 0-7, with a higher score indicating more prevalent symptoms. A total score is then calculated using the summed symptom mean scores, ranging from 0-63, with a higher score indicating more prevalent symptoms.|Baseline to 7 days of study medication||||Scores on a scale||Standard Deviation|Mean
2704471|NCT01212484|Primary|24 Hour Dopamine Levels|Assay of 24 hour dopamine level excretion in urine|4 weeks||||ug/gCR||Standard Deviation|Mean
2704472|NCT01212484|Secondary|Number of Episodes of Daily Nausea||4 weeks||||episodes of nausea||Standard Deviation|Mean
2704473|NCT01212484|Primary|Composite Daily Score|Daily scores were reported on a modified version of the Rhodes Index of Nausea, Vomiting and Retching, which included all 5 items relating to nausea and retching. Items addressing vomiting/throwing up were omitted, as all participants had antireflux surgery that prevented vomiting (Nissen fundoplication). Retching distress, nausea distress, number of nausea episodes per day, number of retching episodes per day, and the amount of time spent feeling nauseous were graded on a 5-point scale. Scores range from 0 (no nausea/distress) to 20 (most nausea/distress).|4 weeks||||units on a scale||Standard Deviation|Mean
2704474|NCT01212445|Secondary|Mean Participant Global Assessment of Treatment|At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|From time of study drug administration up to 2 Days|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.|||units on a scale||Standard Deviation|Mean
2704475|NCT01212445|Secondary|Mean VAS Rating for Abdominal Discomfort/Cramping|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
2704476|NCT01212445|Secondary|Mean VAS Rating for Bloating|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
2704536|NCT01211665|Primary|Time Course Change in Magnetoencephalography (MEG) Results|MEG was used to map brain activity.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; no data on this endpoint was collected.||||||
2704477|NCT01212445|Secondary|Mean VAS Rating for Gas|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
2704478|NCT01212445|Secondary|Mean Visual Analog Scale (VAS) Rating for BM Control|"The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group"|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
2704479|NCT01212445|Secondary|Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 12 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.|||percentage of participants|||Number
2704480|NCT01212445|Secondary|Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration|Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).|From time of study drug administration up to 3 Days|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had a successful bowel movement (no straining or hard/lumpy stools). Participants who reported no successful BMs were censored.|||participants|||Number
2704481|NCT01212445|Primary|Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 24 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.|||percentage of participants|||Number
2704482|NCT01212302|Primary|Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)|"In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.~The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section)."|2 years|Sample size calculation: With the assumption that the incidence of clopidogrel low response was at least 20% and ASA low response 10%. Choosing a power of 97.5% and a two-sided value of 0.05, an overall sample size was required of at least 400 patients. To compensate for a possible loss of follow-up, we aimed for inclusion of approx. 500 patients.|||participants||95% Confidence Interval|Number
2704483|NCT01212185|Secondary|CIWA-Ar Scores|Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.|days 1||||units on a scale||Standard Deviation|Mean
2704484|NCT01212185|Primary|Total Lorazepam Dosage (in Milligrams)|Total lorazepam (in milligrams) required per subject to complete detoxification|Days 1 to 5||||milligrams of lorazepam||Standard Deviation|Mean
2704485|NCT01212172|Secondary|Pain Rating Scale|Pain during each treatment was measured subjectively by patients on a 0-10 visual analogue scale (0=no pain, 10=unbearable pain).|12 months||||Units on a Scale||95% Confidence Interval|Median
2704486|NCT01212172|Primary|Change in Hair Growth|% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]|1 month, 6 month, 12 month||||% hair reduction||Standard Deviation|Mean
2704487|NCT01212159|Secondary|LDL Values at Two Week Interval|Participant in the self monitored arm reported LDL every two weeks. LDL goal for treatment was 100 mg/dl and subjects were followed every two weeks to observe mean LDL values.|6 weeks|No self monitoring group had LDL levels only at baseline and 6 months.|||mg/dl||Standard Deviation|Mean
2704488|NCT01212159|Secondary|Medication Compliance|Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.|6 months||||units on a scale||Standard Deviation|Mean
2704489|NCT01212159|Primary|LDL Level Change From Baseline|Comparison of serum LDL level between control and intervention subjects|baseline to 6 months||||mg/dl||Standard Deviation|Mean
2704527|NCT01211756|Primary|Total Score on Montgomery-Asberg Depression Rating Score (MADRS)|The MADRS is a clinician-rated assessment used to measure the severity of depressive episodes in patients with mood disorders. The measure contains 10 items and each item is scored in a range of 0 to 6 points, with higher score indicating increased depressive symptoms.|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704490|NCT01212107|Secondary|Pharmacokinetics (PK): Area Under the Concentration vs Time Curve 0 to Tau ( AUC[0-t]) of LY2874455|Area under the concentration-time curve from time 0 to the end of the dosing interval (e.g., BID) calculated by a combination of linear and logarithmic trapezoidal methods (linear-up/log-down method).|Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 H|All participants who received at least one dose of study drug and had evaluable PK data.|||Hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704491|NCT01212107|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY2874455|Maximum observed concentration during a dosing interval.|Part A and B: Cycle 1, Day 1, Pre-Dose, 0.5 Hr (H), 1 H, 2 H, 4H,8 H,12 H,24 H; Day 28, Pre-Dose, 0.5 H, 1 H, 2 H, 4 H, 8 H|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704492|NCT01212107|Secondary|Percentage of Participants With Best Overall Response Rate (BORR) and Objective Response Rate (ORR)|"BORR is evaluated using response evaluation criteria in solid tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.~Best overall response rate = (unconfirmed CR+ unconfirmed PR) / subjects in efficacy population.~Objective response rate = (confirmed CR+ confirmed PR) / subjects in efficacy population."|BORR: Baseline Up to 60 Weeks ; ORR: Baseline Up to 60 Weeks|All participants who received at least one dose of study drug and who had CT Scan and progressed.|||percentage of participants|||Number
2704493|NCT01212107|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 60 Weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2704494|NCT01212107|Primary|Recommended Dose for Phase 2 Studies : Maximum Tolerated Dose (MTD)|MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified.|Baseline Up to 32 Weeks|All participants who received at least one dose of study drug in Part A.|||mg|||Number
2704495|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||Z score||Inter-Quartile Range|Median
2704496|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
2704497|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
2704498|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.~trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||units on a scale||Inter-Quartile Range|Median
2704499|NCT01212094|Secondary|EDSS|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|0 months||||units on a scale||Inter-Quartile Range|Mean
2704500|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||Z score||Inter-Quartile Range|Median
2704528|NCT01211730|Secondary|Death Within 1 Year|Death following liver transplant between 1 day and 1 year|1 year||||participants|||Number
2704529|NCT01211730|Secondary|Overall Graft Survival at 1 Year||1 year following transplantation||||participants|||Number
2704530|NCT01211730|Secondary|Rehospitalization Rates||Within 1 year following transplantation|patients undergoing liver transplant|||participants|||Number
2704501|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
2704502|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
2704503|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.~trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||units on a scale||Inter-Quartile Range|Median
2704504|NCT01212094|Secondary|Expanded Disability Status Scale (EDSS)|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility|||units on a scale||Inter-Quartile Range|Median
2704505|NCT01212094|Primary|Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of B-cell activating factor (BAFF) before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. BAFF is consumed by B cells, therefore effective B cell depletion increases levels of BAFF. The protocol-stipulated threshold for trial continuation was at least 50% increase in CSF BAFF induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug.|||percentage of BAFF change||Inter-Quartile Range|Median
2704506|NCT01212094|Primary|Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of chemokine CXCL13 before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. CXCL13 is released by activated B cells, T cells and by follicular dendritic cells and has been linked previously with MS inflammation in the brain and spinal cord. The protocol-stipulated threshold for trial continuation was at least 25% decrease in CSF CXCL13 induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug|||percentage of b cell depletion||Inter-Quartile Range|Median
2704507|NCT01212094|Secondary|Analysis of Changes in CSF B Cell Numbers Between Rituximab and Placebo|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares absolute numbers of CSF B cells calculated as proportion of B cells (identified from flow cytometry data) in all immune cells measured in 50-fold concentrated CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing.|3 months|These patients were analyzed for the interim analysis for the efficacy of B cell depletion. Trial stipulated stopping criteria for futility.|||percentage of b cell depletion||Inter-Quartile Range|Median
2704508|NCT01211873|Secondary|Number of Lesions|The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient|up to 24 hours|The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants are included in this data set.|||Number of lesions||Standard Deviation|Mean
2704509|NCT01211873|Secondary|Diagnostic Confidence Score|Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5).|up to 24 hours|The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants are included in this data set.|||units on a scale||Standard Deviation|Mean
2704510|NCT01211873|Secondary|Image Quality Score|Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality.|up to 24 hours|The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants are included in this data set.|||units on a scale||Standard Deviation|Mean
2704531|NCT01211730|Secondary|Infection Rates||Within 1 year following transplantation|patients having had liver transplants|||participants|||Number
2704532|NCT01211730|Secondary|Hypoglycemia|Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation|Within first 3 days following transplantation|Patients having liver transplant|||participants|||Number
2704511|NCT01211873|Primary|"MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both Pre and Paired Evaluation"|"To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.~Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. Pre refers to unenhanced MRI. PAIRED refer to combined unenhanced and enhanced MRI.~The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0."|up to 24 hours|The primary analysis was performed at the patient level using off-site readings by 3 readers. The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants were included in this data set.|||units on a scale||Standard Deviation|Mean
2704512|NCT01211769|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|3 months||||Units on a Scale||Standard Deviation|Mean
2704513|NCT01211769|Secondary|Short Alcohol Dependence Data Questionnaire (SADD)|The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.|3 months||||Units on a Scale||Standard Deviation|Mean
2704514|NCT01211769|Primary|"Drinking Days in the Previous Month"|The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.|3 months||||Days||Standard Deviation|Mean
2704515|NCT01211756|Secondary|Continuous Performance Test (CPT)|"Patients are told that they will see a series of letters presented on a screen. They are told to click a computer mouse only when they see the target stimulus, for instance the letter X, and must refrain from clicking if they see any other letter presented."|Performed at the beginning and end of each treatment arm|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704516|NCT01211756|Secondary|Letter Number Sequencing Memory Test|The examinee is read a combination of numbers and letters and is asked to recall the numbers first in ascending order and then the letters in alphabetical order. Each item consists of three trials, and each trial is a different combination of numbers and letters.|Performed at the beginning and end of each treatment arm|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704517|NCT01211756|Secondary|California Verbal Learning Test|The subject is read a list of words and asked to repeat them back first after the list is read and again 20 minutes later.|Performed at the beginning and end of each treatment arm|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704518|NCT01211756|Secondary|Peabody Picture Vocabulary Test|The subject is read a series of words and is shown line drawings and is asked to match the word to the drawing.|Performed at the beginning of the study|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704519|NCT01211756|Secondary|Arizona Sexual Experience Scale (ASEX)|The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 (Extremely strong, easily, or satisfying) to 6 (Absent or never) based on how he/she feels at the time.|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704520|NCT01211756|Secondary|Profile of Mood States (POMS)|The POMS is a self-rated scale to assess current mood states. The POMS consists of 65 words that the subject will rate from 1 (not at all) to 5 (extremely) based on how he/she feels at the time.|Performed at the beginning and end of each treatment arm|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704521|NCT01211756|Secondary|Reading Trust in the Mind's Eye Test|The subject will view approximately 16 faces and asked to rate trustfulness of the person in the picture.|Performed at the beginning and end of each treatment arm.|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704522|NCT01211756|Secondary|Hamilton-Anxiety Scale (HAM-A)|The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. The HAM-A consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704523|NCT01211756|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is an 11-item assessment used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observed.|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704524|NCT01211756|Secondary|Clinical Global Impression-Global Improvement (CGI-I)|The CGI-I is a global assessment to evaluate the subjects' improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704525|NCT01211756|Secondary|Clinical Global Impression-Severity of Illness (CGI-S)|The CGI-S is used to evaluate changes in overall severity of illness. Scores on the CGI-S range from 1 (not at all) to 7(among the most extremely ill).|Performed at each visit (weekly)|The PI has left the institution and there was only one subject enrolled, the results will not be analyzed.||||||
2704548|NCT01211600|Secondary|Number of Participants Diagnosed With Endomyometritis|Number of participants diagnosed with endomyometritis requiring antibiotics|Immediate postpartum.||||Participants|||Count of Participants
2704537|NCT01211665|Primary|Time Course Changes in Brain Magnetic Resonance Imaging (MRI)|The brain MRI data collected included: progressive multifocal leukoencephalopathy (PML) lesion localization, T2 hyperintense lesion volume, and signs of cerebral edema.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
2704538|NCT01211665|Primary|Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
2704539|NCT01211665|Primary|Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale|The GCI-I scale is a 7-point scale that assesses how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rates it as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
2704540|NCT01211665|Primary|Severity of AEs and SAEs|AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period||||events|||Number
2704541|NCT01211665|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period||||participants|||Number
2704542|NCT01211665|Primary|Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)|Following the completion of rapid removal of natalizumab using PLEX or equivalent.|6 months||||participants|||Number
2704543|NCT01211665|Primary|Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)|The Karnofsky Performance Status Index (KPSI) is an assessment tool intended to assist clinicians and caretakers in gauging a patient's functional status and ability to carry out activities of daily living. A KPSI of 100=normal, no complaints, no evidence of disease; 90=able to carry on normal activity, minor signs or symptoms of disease; 80=normal activity with effort, some signs or symptoms of disease; 70=cares for self, unable to carry on normal activity or do active work; 60=requires occasional assistance but is able to care for most personal needs; 50=requires considerable assistance and frequent medical care; 40=disabled, requires special care and assistance; 30=severely disabled, hospitalization is indicated, although death is not imminent; 20=very sick, hospitalization is necessary, active support treatment is necessary; 10=moribund, fatal processes progressing rapidly; 0=dead.|Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
2704544|NCT01211613|Secondary|Numeric Pain Rating Score.|"Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating no pain and 10 indicating unbearable pain. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment)."|4 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2704545|NCT01211613|Primary|Oswestry Low Back Pain Disability Index|The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).|4 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2704546|NCT01211600|Secondary|Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.|Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.|Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.||||score on a scale||Inter-Quartile Range|Median
2704547|NCT01211600|Secondary|Change in Hemoglobin Pre-operatively to Post-operatively|Median change in hemoglobin from preoperative value (g/dL) to post-operatively.|Up to 72 hours before and 24 hours after cesarean.||||g/dL||Inter-Quartile Range|Median
2704554|NCT01211600|Secondary|Additional Provider Visits|Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).|Within 6 weeks postpartum|"The number analyzed in the Number of visits - diagnosed wound complication and Number of visits - no diagnosed wound complication rows indicates the breakdown of subjects within each arm that did and did not have a diagnosed wound complication."|||Number of Visits per participant||Full Range|Mean
2704555|NCT01211600|Secondary|Pain Perception|Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.|Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean||||score on a scale||Inter-Quartile Range|Median
2704556|NCT01211600|Secondary|Patient Satisfaction With Closure Method and Scar Appearance|Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.|Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.|Patient satisfaction data were available for 606 participants. Two participants in the Staples arm did not provide scores for scar appearance satisfaction. This is why we are representing 305 of the 307 subjects' responses to satisfaction of scar appearance.|||score on a scale||Inter-Quartile Range|Median
2704557|NCT01211600|Secondary|Patient Scar Assessment Scale Scores for Evaluation of Cosmesis|"Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures.~Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior."|Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.||||score on a scale||Inter-Quartile Range|Median
2704558|NCT01211600|Primary|Number of Participants With Wound Complications|"The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture.~Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication."|Within 6 weeks of postpartum||||Participants|||Count of Participants
2704559|NCT01211535|Primary|Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort."|Baseline (Day 0), Day 14|All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)|||Units on a scale||95% Confidence Interval|Least Squares Mean
2704560|NCT01211522|Secondary|Time to Hospital Discharge|"Days from randomization to successful hospital discharge, where successful indicates that discharge was followed by at least 48 hours alive."|90 days||||days||Inter-Quartile Range|Median
2704561|NCT01211522|Secondary|Time to ICU Readmission|Days from first ICU discharge to next ICU readmission.|90 days after first ICU discharge|Time to ICU readmission reported among those who were readmitted to the ICU|||days||Inter-Quartile Range|Median
2704562|NCT01211522|Secondary|Time to Final ICU Discharge|"Days from randomization to final, successful ICU discharge, where successful indicates that discharge was followed by at least 48 hours alive. ICU discharge is represented by readiness for ICU discharge indicated by a physician order for transfer to a lower level of care even if a bed availability problems prevent actual discharge from the ICU."|90 days||||days||Inter-Quartile Range|Median
2704563|NCT01211522|Secondary|Time to Liberation From Mechanical Ventilation|"Days from randomization to successful liberation from mechanical ventilation, where successful indicates that liberation was followed by at least 48 hours alive and without reinitiation of invasive or noninvasive ventilation."|30 days||||days||Inter-Quartile Range|Median
2704564|NCT01211522|Secondary|Number of Participants With Neuroleptic Malignant Syndrome||14 days plus 4-day post-study drug period (if longer than 14 days)||||Participants|||Count of Participants
2704565|NCT01211522|Secondary|Number of Participants With Extrapyramidal Symptoms||14 days plus 4-day post-study drug period (if longer than 14 days)||||Participants|||Count of Participants
2704566|NCT01211522|Secondary|Number of Participants With Torsades de Pointes||14 days plus 4-day post-study drug period (if longer than 14 days)||||Participants|||Count of Participants
2704567|NCT01211522|Secondary|Delirium Duration|Duration of delirium during the intervention period|14 days||||days||Inter-Quartile Range|Median
2704568|NCT01211522|Secondary|Mortality|Deaths within the specified timeframe|30-day and 90-day||||Participants|||Count of Participants
2704569|NCT01211522|Primary|Delirium/Coma-free Days (DCFDs)|Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma.|14 days||||days||Inter-Quartile Range|Median
2704570|NCT01211340|Secondary|Anxiety|This measure determines the level of anxiety experienced by a hospice caregiver. Total scores range from 0-21 with higher scores representing more anxiety. Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure||||units on a scale||Standard Deviation|Mean
2704571|NCT01211340|Secondary|Caregiver Quality of Life-Revised Subscale Emotional|This is one domain of a four domain instrument. It involves one question with a range of 0-10.Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure||||units on a scale||Standard Deviation|Mean
2704599|NCT01210807|Secondary|Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity||4-6 months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.|||participants|||Number
2704572|NCT01211340|Primary|Caregiver Perceptions of Pain Medicine Questionaire|This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications. Scores on items vary from 1-5 with the lower scores indicating more problematic perceptions of pain management. A Total score is computed between 16-80 Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure||||units on a scale||Standard Deviation|Mean
2704573|NCT01211197|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|Drug administration up to 7 days after last drug administration, up to 8 days|Treated set (TS) includes all subjects who took at least 1 dose of investigational medication and was used for safety analysis.|||participants|||Number
2704574|NCT01211197|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||Litres||Standard Deviation|Mean
2704575|NCT01211197|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of the analyte in the plasma after extravascular administration.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||mL/min||Standard Deviation|Mean
2704576|NCT01211197|Secondary|Mean Residence Time in the Body After Oral Administration (MRTpo)|"Mean residence time of the analyte in the body after oral administration.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||hours||Standard Deviation|Mean
2704577|NCT01211197|Secondary|Terminal Half-life in Plasma (T1/2)|"Terminal half-life of the analyte in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||hours||Standard Deviation|Mean
2704578|NCT01211197|Secondary|Terminal Elimination Rate Constant in Plasma (λz)|"Terminal elimination rate constant in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||1/h||Standard Deviation|Mean
2704579|NCT01211197|Secondary|Time to Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum concentration of the analyte in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||hours||Full Range|Median
2704580|NCT01211197|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of metformin in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2704581|NCT01211197|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||ng*h/mL||Standard Deviation|Mean
2704582|NCT01211197|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||ng*h/mL||Standard Deviation|Mean
2709323|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2704583|NCT01211197|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||nmol*h/L||Standard Deviation|Mean
2704584|NCT01211197|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||nmol/L||Standard Deviation|Mean
2704585|NCT01211197|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the coefficient of variation (CV)."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||nmol*h/L||Standard Deviation|Mean
2704586|NCT01211184|Secondary|Muscle Catabolism|Assessed by the ratio of 3-methylhistidine/creatinine in excreted urine (unit: mmol/mmol).This is an amino acid unique to muscle that does not undergo intermediary metabolism, meaning that its urinary excretion is an index of the degree of muscle catabolism.|From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)|Per protocol|||mmol/mmol||Standard Deviation|Mean
2704587|NCT01211184|Primary|Change in Insulin Sensitivity (Percent)|Insulin sensitivity (micro-mol per kg per minute glucose uptake) was calculated based on an intravenous glucose tolerance test (Theor Biol Med Model 2011, 8: 12) on the day before surgery. The percent change was taken as (day after - day before) / day before|Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).|Per protocol analysis. The study was powered to detect a difference in glucose clearance.|||percent change of insulin sensitivity||Inter-Quartile Range|Median
2704588|NCT01211145|Secondary|Use of Rescue Medication During the First 24 Hours After Treatment||24 hours post-treatment.|Full analysis set (observed cases)|||Participants|||Number
2704589|NCT01211145|Secondary|Sustained Headache Response at 2 Hours|Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.|Up to 2 hours post-treatment|Full analysis set (observed case)|||Participants|||Number
2704590|NCT01211145|Secondary|Headache Response at 24 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|24 hours post-treatment|Full analysis set (observed case)|||Participants|||Number
2704591|NCT01211145|Secondary|Headache Response at 2 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|2 hours post-treatment|Full analysis set (last observation carried forward)|||Participants|||Number
2704592|NCT01211145|Secondary|Pain-free Status at 24 Hours Post-treatment||24 hours post-treatment|Full analysis set (observed case)|||Participants|||Number
2704593|NCT01211145|Primary|Pain-free Status at 2 Hours Post-treatment||2 hours post-treatment.|Full analysis set (last observation carried forward)|||Participants|||Number
2704594|NCT01211106|Primary|Drinking Outcome|Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.|16 weeks|The number of subjects available for this measure are greater than the PTSD outcome as drinking outcomes can be obtained at anytime and thus some participants provided data at the post study evaluation.|||percent days ofheavy drinking||Standard Deviation|Mean
2704595|NCT01211106|Primary|PTSD Symptoms|PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.|16 weeks||||units on a scale||Standard Deviation|Mean
2704596|NCT01210820|Primary|Change in Keratometric Cylinder|Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.|6 Months||||Diopters of astigmatism change||Standard Deviation|Mean
2704597|NCT01210820|Primary|Change in Refractive Astigmatism|Change in mean cylinder (assessed by manifest refraction) compared to baseline.|6 months||||Diopter of cylinder change||Standard Deviation|Mean
2704598|NCT01210807|Primary|Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm|Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.|4-6 Months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.|||logMAR visual acuity||Standard Deviation|Mean
2704600|NCT01210716|Secondary|Safety Measured by Adverse Events During the TPE Procedure||Adverse events were collected during each TPE procedure.|Adverse events were summarized for enrolled subjects per protocol. 7 out of 37 enrolled subjects experienced adverse events during the study with a total of 12 adverse events reported.|||participants|||Number
2704601|NCT01210716|Primary|Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure|"The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure.~Plasma Efficiency = (plasma removed/plasma processed)*100"|After completion of the TPE procedure.|A total of 37 patients who consented and enrolled started the 1st procedure. Of these 37 patients, 33 patients completed the 1st procedure and started a 2nd procedure. Three patients did not complete the second procedure resulting in 30 patients with completed paired Test and Control procedures.|||percentage of plasma removal efficiency||Full Range|Mean
2704602|NCT01210690|Secondary|Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period|Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment.|||participants|||Number
2704603|NCT01210690|Secondary|Global Evaluation Scale of Epilepsy Severity (GES)|"Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options:~7=Marked improvement~6=Moderate improvement~5=Slight improvement~4=No Change~3=Slight worsening~2=Moderate worsening~1=Marked worsening~As a variant of this variable, a 3-class variable was derived as follows~Marked improvement, Moderate improvement, and Slight improvement were defined as Improved.~No change was defined as Stable.~Slight worsening, Moderate worsening, and Marked worsening were defined as Worsened."|From Baseline to the last Treatment Visit (maximum time frame is 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.|||participants|||Number
2704604|NCT01210690|Secondary|Global Evaluation Scale of the Psychomotor Development (GES)|"Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options:~7=Marked improvement~6=Moderate improvement~5=Slight improvement~4=No Change~3=Slight worsening~2=Moderate worsening~1=Marked worsening~As a variant of this variable, a 3-class variable was derived as follows~Marked improvement, Moderate improvement, and Slight improvement were defined as Improved.~No change was defined as Stable.~Slight worsening, Moderate worsening, and Marked worsening were defined as Worsened."|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.|||participants|||Number
2704605|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit|The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.|From Baseline to the last Treatment Visit (maximum 12 months)|||||||
2704606|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit|"Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).~The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs."|From Baseline to the last Treatment Visit (maximum 12 months)|||||||
2704607|NCT01210690|Secondary|Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit|For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||z-scores||Standard Deviation|Mean
2704608|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit|For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||z-scores||Standard Deviation|Mean
2704609|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit|For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.|From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||z-scores||Standard Deviation|Mean
2704832|NCT01209195|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 163 weeks, and a collection was made post-infusion in any case of infusion reaction|||||||Number
2704610|NCT01210690|Secondary|Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit|Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication. Presented is the number of subjects with non-missing data on psychomotor development at the corresponding visit.|||participants|||Number
2704611|NCT01210690|Secondary|Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||participants|||Number
2704612|NCT01210690|Secondary|Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up|Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||participants|||Number
2704613|NCT01210690|Primary|Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||participants|||Number
2704614|NCT01210664|Secondary|Hemoglobin A1c|Secondary diabetes-related outcome measure will include hemoglobin A1c|Up to 104 weeks|Population includes 14 participants treated|||% of HbA1c||Standard Deviation|Mean
2704615|NCT01210664|Secondary|Insulin Use|Secondary diabetes-related outcome measure will include insulin use|up to 104 weeks|Population includes 14 participants treated.|||U/day/kg||Standard Deviation|Mean
2704616|NCT01210664|Secondary|Percent Change From Baseline in C-peptide Area Under the Curve|Secondary diabetes-related outcome measure: C-peptide response during mixed meal tolerance test at 26 and 52 weeks, reported as the change from baseline in the area under the curve.|26 and 52 weeks from baseline|Population includes 14 participants treated.|||percentage change from baseline||Standard Deviation|Mean
2704617|NCT01210664|Primary|Number of Participants Experiencing Severe or Life Threatening Laboratory Abnormalities|"Laboratory measures tested include: hematology, blood chemistry, endocrine values, autoantibodies, and ophthalmologic exam results~Total number of participants experiencing severe or life-threatening laboratory abnormalities is reported for each cohort. Events reported include hyperglycemia and hypoglycemia."|Mean follow-up of 31 months|Safety analysis includes 14 treated participants who received one dose of PolyTregs at Day 0, two participants who underwent blood draw but did not receive PolyTregs were also included in the safety analysis.|||Participants|||Count of Participants
2704618|NCT01210664|Primary|Adverse Events (AEs) as a Measure of Safety and Tolerability|The number of AEs are reported by cohort and severity.|Mean follow-up of 31 months|Safety analysis includes 14 treated participants who received one dose of PolyTregs at Day 0, two participants who underwent blood draw but did not receive PolyTregs were also included in the safety analysis.|||adverse events|||Number
2704619|NCT01210651|Secondary|Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers|The Rosenberg Self-Esteem Scale (RSES) is a 10-item, self-administered, validated psychometric instrument to measure self-esteem, defined as having an overall feeling of self-worth and self-acceptance. Each item is scored from 0 to 3, and individual item scores are summed to yield a total possible RSES ranging from 0-30. RSES scores from 0-14 suggest low self-esteem, from 15-25 normal self-esteem, and from 26-30 high self-esteem. RSES scores of study completers were examined, and the total change score on RSES was calculated for each intervention group as the mean RSES score at 0 wks subtracted from the mean RSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.|||points on a scale||Standard Deviation|Mean
2704620|NCT01210651|Secondary|Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers|The General Self-Efficacy Scale (GSES) is a 10-item, self-administered, validated psychometric instrument to measure self-efficacy, defined as the belief that one's actions are responsible for successful outcomes in coping with difficult life demands. Each item is scored from 1 to 4, with a total GSES score derived by summing the individual item scores. Possible GSES scores range from 10 (no belief in one's self-efficacy) to 40 (strongest belief in one's self-efficacy). GSES scores of study completers were examined, and the total change score on GSES was calculated for each intervention group as the mean GSES score at 0 wks subtracted from the mean GSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.|||points on a scale||Standard Deviation|Mean
2704630|NCT01210560|Secondary|Change From Baseline in Number of Urine Voids During Sleep Periods.|Average number of daily urine voids during sleep periods for each dose group. Day 1 was defined as Day 1 of Period 1, Day 8 of Period 2, Day 15 of Period 3; Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3; Same rule applied to Day 2 to 6.|Days 1, 2, 3, 4, 5, 6 and 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Number of urine voids||Standard Deviation|Mean
2704621|NCT01210651|Primary|Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Analysis examined BDI scores of study completers and identified in each intervention group the number of participants with an 8-wk BDI score ≤ 9, defined as remitted depression.|8 Weeks|Population of study completers with remitted depression was comprised of participants in both intervention groups who provided study measures at 0 wks and 8 wks, and achieved an 8-wk BDI score ≤ 9.|||participants|||Number
2704622|NCT01210651|Primary|Total Change Scores on Beck Depression Inventory-II Among Study Completers|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. BDI scores of study completers were examined, and the total change score on BDI was calculated for each intervention group as the mean BDI score at 0 wks subtracted from the mean BDI score at 8 wks.|0 wks and 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention end at 8 wks.|||points on a scale||Standard Deviation|Mean
2704623|NCT01210651|Primary|Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Regression analysis software examined the BDI scores measured in study participants every 2 wks from intervention start at 0 wks until intervention end at 8 wks, using maximum likelihood estimations to derive an adjusted mean BDI score for each intervention group at each measurement point.|0 wks, 2 wks, 4 wks, 6 wks, 8 wks|Intent-to-Treat population was comprised of all randomized participants in both intervention groups, regardless of adherence to protocol or premature dropout. BDI scores of any participants missing at 0 wks were imputed by carrying forward their BDI scores from screening.|||points on a scale||95% Confidence Interval|Least Squares Mean
2704624|NCT01210560|Secondary|Ranking of Treatment Tolerability.|"Ranking of treatment tolerability was evaluated based on a questionnaire. At Day 22, participants were asked the following questions and their responses recorded on the eCRF: Which treatment period did you find most tolerable? and Which treatment period did you find the least tolerable?."|Day 22/Early Termination|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Participants|||Number
2704625|NCT01210560|Secondary|Change From Baseline in Urinary Frequency Questionnaire (Question 2 and Questions 3 to 10) at Day 6.|"Question 2 asked, During the last 5 days, how much has urinary frequency bothered you? In order to score the response, the written answers were assigned values from 0 to 4 as follows: 0) Not at all, 1) Somewhat, 2) Moderately, 3) Quite a bit, and 4) Constantly.~Question 3 to Question 10 were assigned scores of 0 to 4 with higher scores indicating worse cases in impact of urinary frequency on life; scores for these questions were pooled, with a maximum possible score of 32.~Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3."|Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Units on a scale||Standard Deviation|Mean
2704626|NCT01210560|Secondary|Number of Participants Experiencing Urinary Frequency Based on Urinary Frequency Questionnaire (Question 1) at Baseline and Day 6.|"The ADPKD Urinary Frequency Questionnaire: Question 1 (currently experiencing frequency) was assigned 'Yes' or 'No' to measure current urine frequency status.~Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3."|Baseline and Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Participants|||Number
2704627|NCT01210560|Secondary|Change From Baseline in Urinary Urgency Questionnaire (Questions 2 to 5 and Questions 7 to 14) at Day 6.|"Question 2 to Question 6 were assigned scores of 0 to 4 with higher scores indicating worse cases in experience of urinary urgency. Scores for Question 2 to Question 5 were pooled, with a maximum possible score of 16.~Question 6 was excluded from the analysis since it was only asked at screening. Question 7 to Question 14 were also assigned scores of 0 to 4 with higher scores indicating worse cases in impact of urinary urgency on life; scores for these questions were pooled, with a maximum possible score of 32.~Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3."|Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Units on a scale||Standard Deviation|Mean
2704628|NCT01210560|Secondary|Number of Participants Experiencing Urinary Urgency Based on Urinary Urgency Questionnaire (Question 1) at Baseline and Day 6.|For the ADPKD Urinary Urgency Questionnaire, Question 1 (currently experiencing urgency?) was assigned 'Yes' or 'No' to measure current urine urgency status. Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3.|Baseline and Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Participants|||Number
2704629|NCT01210560|Secondary|Change From Baseline in Symptom Burden by Autosomal Dominant Polycystic Kidney Disease (ADPKD) Nocturia Quality of Life Questionnaire at Day 6.|In ADPKD Nocturia Quality of Life Questionnaire, questions 1 to 11 (with possible scores ranging from 0 to 4 and higher scores indicating better quality of life) were pooled to provide a total score (maximum of 44 points). Response scores of Question 12 (with possible scores ranging from 1 to 10, with higher scores indicating more interference (worse quality of life) with everyday life due to urination at night) were pooled separately. Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3.|Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Units on a scale||Standard Deviation|Mean
2706683|NCT01195090|Secondary|Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||HOMA-IR score||Standard Error|Least Squares Mean
2704631|NCT01210560|Secondary|Change From Baseline in Number of Urine Voids During Awake Periods.|Average number of daily urine voids during awake periods for each dose group. Day 1 was defined as Day1 of Period 1, Day 8 of Period 2 adn Day 15 of Period 3; Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3; Same rule applied to Day 2 and Day 6.|Days 1, 2, 3, 4, 5, 6 and 7|All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included.|||Number of urine voids||Standard Deviation|Mean
2704632|NCT01210560|Secondary|Duration of Urine Osmolality Less Than 300 mOsm/kg at Baseline and Day 7.|Duration of urine osmolality remains below 300 mOsm/kg was the sum of the durations (nominal times) of all intervals where the urine concentration was < 300 mOsm/kg. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2, and Day 21 of Period 3.|Baseline and Day 7|The duration that urine osmolality remained < 300 mOsm/kg was not calculated. Instead was calculated as the sum where urine osmolality was < 300 mOsm/kg in the 24-hour postdose period. The change was made because low doses of the MR formulation frequently do not produce suppression of urine osmolality in the 0- to 4-hour period.|||Hours||Full Range|Median
2704633|NCT01210560|Secondary|Change From Baseline in Urine Volume by Interval at Day 7.|Urine volume collected was by interval (0-4, 4-8, 8-12, 12-16, 16-24 hours). Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3.|0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||mL||Standard Deviation|Mean
2704634|NCT01210560|Secondary|Change From Baseline in Urine Volume at 24 Hours at Day 7.|Urine volume was collected by 0 to 24-hour interval at Day 7. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3.|Day 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||mL||Standard Deviation|Mean
2704635|NCT01210560|Secondary|Change From Baseline in Urine Osmolality at Day 7.|To determine the tolerability and nighttime urinary suppression of osmolality. The urine osmolality was summarized by collection interval (0 to 4, 4 to 8, 8 to 12, 12 to 16, and 16 to 24 hours)|0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||mOsm/kg||Standard Deviation|Mean
2704636|NCT01210560|Secondary|Change From Baseline in Urine Osmolality Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24h) at Day 7.|The AUC0-24h for urine osmolality was determined by multiplying the concentration by the collection interval duration for each collection interval and summing all the intervals in the 24-hour period. If the urine volume for an interval is zero, the duration of that interval will be added to the next collection interval. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3.|Day 7|All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included.|||mOsm/kg*Hour||Standard Deviation|Mean
2704637|NCT01210560|Secondary|Number of Participants With Urine Osmolality < 300 mOsm/kg at 23.5 Hours Postdose.|For determination of duration of urine osmolality <300 mOsm/kg, the value was the end time of the last collection interval in which urine osmolality was <300 mOsm/kg. Day 8 in the table below was defined as Day 8 of Period 1, Day 15 of Period 2, and Day 22 of period 3.|23.5 hours post-dose|All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included.|||Participants|||Count of Participants
2704638|NCT01210560|Primary|Area Under the Concentration-time Curve During the Dosing Interval at Steady State and Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUCT & AUC0-24h) After Tolvaptan Treatment on Day 7.|Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Hence, both AUCT and AUC0-24h values were calculated.|Day 7|Participants having valid measurements (per clinical pharmacology) were included.|||ng·h/mL||Standard Deviation|Mean
2704639|NCT01210560|Primary|Time to Maximum (Peak) Plasma Concentration (Tmax) After Tolvaptan Treatment on Day 7.|Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Time to maximum plasma concentration was calculated.|Day 7|Participants having valid measurements (per clinical pharmacology) were included.|||Hours||Full Range|Median
2704640|NCT01210560|Primary|Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7.|Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Maximum and minimum plasma concentration of the drug was calculated.|Day 7|Participants having valid measurements (per clinical pharmacology) were included.|||ng/mL||Standard Deviation|Mean
2704641|NCT01210495|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) in Randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
2704642|NCT01210495|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) in Randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
2704643|NCT01210495|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) in Non-Randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
2704644|NCT01210495|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) in Non-Randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
2704645|NCT01210495|Secondary|Number of Participants With Dose-Limiting Toxicities (DLTs) in Non-Randomized Portion|Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.|Cycle 1 (4 weeks)|Participants with Child-Pugh Class B, score 7 are only included in this analysis.|||participants|||Number
2704646|NCT01210495|Secondary|EuroQoL Visual Analogue Scale (EQ-VAS) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D VAS in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704647|NCT01210495|Secondary|EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704648|NCT01210495|Secondary|Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|TTD analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.|From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2704649|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep -TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704650|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|This subscale consists of 18 items rated on a scale from '0' - not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better QoL or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2706684|NCT01195090|Secondary|Changes in High Sensitive C-reactive Protein|fasting high sensitive serum C-reactive protein change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||mg/dl||Standard Error|Least Squares Mean
2704651|NCT01210495|Secondary|Functional Assessment of Cancer Therapy-G (FACT-G) Subscales in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general HRQoL: PWB, SWB, EWB and FWB. Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704652|NCT01210495|Secondary|Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary Symptom Index-8 (FHSI-8) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|"The FACT-Hep includes the FACT-G and a hepatobiliary module. The hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where 0 is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used."|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704653|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): PWB, SWB, EWB and FWB; each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704654|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal (GI)-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
2704655|NCT01210495|Secondary|Percentage of Participants With Specific Micro-Ribonucleic Acid (miRNA) Transcript Present in Circulation in Randomized Portion|A 5 millilitres (mL) whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.|Baseline|The miRNA analysis set included all participants in the safety analysis set who had a baseline miRNA assessment. Safety analysis population included all randomized participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.|||percentage of participants|||Number
2704656|NCT01210495|Secondary|Concentration of Soluble Proteins at Baseline in Randomized Portion|Plasma soluble proteins interleukin-6 (IL-6), E-Selectin, interleukin-8 (IL-8), hepatocyte growth factor (HGF), matrix metalloproteinase-2 (MMP-2), stem cell factor (SCF), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-C (VEGF-C), soluble vascular endothelial growth factor receptor 2 (sVEGFR2), soluble vascular endothelial growth factor receptor 3 (sVEGFR3), stromal cell-derived factor-1 (SDF1), neutrophil gelatinase-associated lipocalin (NGAL), migration inhibitory factor (MIF), c-MET, regulated upon activation normal T cell expressed and presumably secreted (RANTES), and monocyte chemotactic protein-3 (MCP-3) were only measured in randomized participants.|Baseline|The soluble protein analysis set included all participants in the safety analysis set who had a Baseline soluble protein assessment. Safety analysis population included all randomized participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2706685|NCT01195090|Secondary|Changes in Fasting Plasma Glucose|fasting serum sugar change from baseline to 24 weeks|24 weeks|An intent-to-treat (ITT) analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
2704657|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||liters||95% Confidence Interval|Geometric Mean
2704658|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Terminal Plasma Elimination Half-Life (t1/2), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hours||Standard Deviation|Mean
2704659|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
2704660|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hours||Full Range|Median
2704661|NCT01210495|Secondary|Axitinib Steady-State PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 Hour (AUC0-24), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||nanograms*hour per milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
2704662|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2704663|NCT01210495|Secondary|Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion|CBR was defined as the percentage of participants with confirmed CR or confirmed PR or a best response of stable disease >=8 weeks according to RECIST 1.1 criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study >=4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.|From Baseline up to end of treatment|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||percentage of participants||95% Confidence Interval|Number
2704664|NCT01210495|Secondary|Duration of Response (DR) by Unstratified Analysis, Randomized Portion|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR − first CR or PR that was subsequently confirmed +1)/30.4.|From objective response to date of progression or death|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received. DR was calculated for the subgroup of FAS participants with objective response.|||months||95% Confidence Interval|Median
2704665|NCT01210495|Secondary|Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion|TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − first randomization date +1)/30.4.|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2706686|NCT01195090|Primary|Mean Change in Glycosylated Hemoglobin (A1C)|A1C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||percentage of Hb||Standard Error|Least Squares Mean
2704666|NCT01210495|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion|ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the RECIST 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 millimetres [mm]). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Every 8 weeks until at least two years after the last participant has been randomized|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||percentage of participants||95% Confidence Interval|Number
2704667|NCT01210495|Secondary|Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion|PFS was defined as time from randomization to first documented objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date − first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was death). As per response evaluation criteria in solid tumors (RECIST) 1.1, progression was defined as greater than or equal to (>=) 20% increase in sum of longest dimensions of target lesions or appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of PD were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment.|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2704668|NCT01210495|Primary|Overall Survival (OS) - Stratified Analysis, Randomized Portion|OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.|From randomization until at least two years after the last participant has been randomized (up to 6 years)|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2704669|NCT01210443|Secondary|Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||pg/mL||Standard Deviation|Mean
2704670|NCT01210443|Secondary|Percentage of Participants With Change From Baseline in WHO Functional Class|"The change from baseline in WHO functional class was classified into Improved, No change and Worsened. The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48)."|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||Parcentage of participants|||Number
2704671|NCT01210443|Secondary|Change From Baseline in 6-Minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||Meters||Standard Deviation|Mean
2704672|NCT01210443|Secondary|Percentage of Participants With Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||Percentage of participants|||Number
2704673|NCT01210443|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|Up to 22 days (last participant discontinuation)|The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study.|||Participants|||Number
2704674|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|t1/2: Terminal half-life, calculated as λn/(ln 2)|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2709324|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2704675|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704676|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704677|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||h*ng/mL||Standard Deviation|Mean
2704678|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Tlast: The time at which Clast was observed|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||h||Standard Deviation|Mean
2704679|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||ng/mL||Standard Deviation|Mean
2704680|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Tmax: The time at which Cmax was observed|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||h||Standard Deviation|Mean
2704681|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||ng/mL||Standard Deviation|Mean
2704682|NCT01210352|Secondary|Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.|||L/kg||Standard Deviation|Mean
2704683|NCT01210352|Secondary|Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.|||L/h/kg||Standard Deviation|Mean
2709325|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2704684|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|t1/2: Terminal half-life, calculated as λn/(ln 2)|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704685|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704686|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704687|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704688|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Tlast: The time at which Clast was observed|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704689|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng/mL||Standard Deviation|Mean
2704690|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Tmax: The time at which Cmax was observed|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704691|NCT01210352|Secondary|6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng/mL||Standard Deviation|Mean
2704692|NCT01210352|Secondary|Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|t1/2: Terminal half-life, calculated as λn/(ln 2)|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704693|NCT01210352|Secondary|Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704694|NCT01210352|Secondary|Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704704|NCT01210352|Secondary|Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704695|NCT01210352|Secondary|Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||h*ng/mL||Standard Deviation|Mean
2704696|NCT01210352|Secondary|Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Tlast: The time at which Clast was observed|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||h||Standard Deviation|Mean
2704697|NCT01210352|Secondary|Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||ng/mL||Standard Deviation|Mean
2704698|NCT01210352|Secondary|Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Tmax: The time at which Cmax was observed|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||h||Standard Deviation|Mean
2704699|NCT01210352|Secondary|Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval|Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7|Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.|||ng/mL||Standard Deviation|Mean
2704700|NCT01210352|Secondary|Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.|||L/kg||Standard Deviation|Mean
2704701|NCT01210352|Secondary|Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.|||L/h/kg||Standard Deviation|Mean
2704702|NCT01210352|Secondary|Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|t1/2: Terminal half-life, calculated as λn/(ln 2)|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704703|NCT01210352|Secondary|Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704741|NCT01209949|Secondary|Number of Participants With Tolerability Assessments Resulting in an Adverse Event|Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.|12 weeks|Safety|||participants|||Number
2704705|NCT01210352|Secondary|Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h*ng/mL||Standard Deviation|Mean
2704706|NCT01210352|Secondary|Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Tlast: The time at which Clast was observed|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704707|NCT01210352|Secondary|Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Clast: Minimum plasma concentration; the last concentration observed during a dosage interval|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng/mL||Standard Deviation|Mean
2704708|NCT01210352|Secondary|Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Tmax: The time at which Cmax was observed|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||h||Standard Deviation|Mean
2704709|NCT01210352|Secondary|Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval|Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng/mL||Standard Deviation|Mean
2704710|NCT01210352|Primary|Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase|Rescue Medication Use in Multiple Dose Phase|Rescue Medication Use|Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.|||Participants|||Count of Participants
2704711|NCT01210352|Primary|Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase|"Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain).~Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain).~PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point."|0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination|Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.|||score on a scale||Standard Deviation|Mean
2704712|NCT01210352|Primary|Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase|"Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain).~Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain)"|Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue|Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group.|||score on a scale||Standard Deviation|Mean
2704713|NCT01210352|Primary|Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase|"Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain).~Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain).~PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point."|Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue|"Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly."|||score on a scale||Standard Deviation|Mean
2704714|NCT01210352|Primary|Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase|"Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain).~Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain)."|Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue|"Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly."|||score on a scale||Standard Deviation|Mean
2706852|NCT01193842|Secondary|Change in CD8 Cell Counts (Phase I)|Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts.|Baseline up to 12 months|Eligible participants who returned for follow-up with evaluable data.|||cells/mm^3||Inter-Quartile Range|Median
2704715|NCT01210222|Secondary|Progression-free Survival|The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Patients whose disease can be evaluated by physical exam, progression was assessed prior to each cycle. CT or MRI if used to follow leasion for measurable disease, up to 5 years|Eligible and treated patients|||Months||90% Confidence Interval|Median
2704716|NCT01210222|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years|Eligible and treated patients|||Months||90% Confidence Interval|Median
2704717|NCT01210222|Primary|Adverse Events as Assessed by NCI CTCAE v 4.0||Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
2704718|NCT01210222|Primary|Objective Tumor Response (Complete or Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2704719|NCT01210222|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|At 6 months|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2704720|NCT01210170|Secondary|Albuterol Induced Percent Change in Qaw|Qaw will be measured before and 15 min after albuterol inhalation|change in Qaw 15 minutes after albuterol inhalation|As specified by the protocol, -60 minutes values were not to be analyzed if 200 mcg and 400 mcg of mometasone given 30 minutes before albuterol were determined to have no effect|||percent change in Qaw||Standard Error|Mean
2704721|NCT01210170|Primary|Albuterol-induced Change in FEV1|FEV1 will be measured before and after inhalation of 180 mcg albuterol.|15 minutes after albuterol inhalation|As specified by the protocol, -60 minutes values were not to be analyzed if 200 mcg and 400 mcg of mometasone given 30 minutes before albuterol were determined to have no effect|||liters||Standard Error|Mean
2704722|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data for histological pattern of the endometrium in participants with good or poor response to Gonal-f were not summarized because the number of participants in each group with respect to ovarian response were too low.||||||
2704723|NCT01210144|Secondary|Gene Expression in Participants With Good or Poor Response to Gonal-f®|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
2704724|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day 5 or 6 (window of implantation) after Oocyte Retrieval|"ITT population: participants who received at least one dose of study medication. N (number of participants analyzed) signifies participants who were evaluable for this measure. Data were not analyzed for Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) group because there were no participants without blastocyst transfer in this group."|||participants|||Number
2704725|NCT01210144|Secondary|Gene Expression in Participants Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day 5 or 6 (window of implantation) after Oocyte Retrieval|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
2704726|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"ITT population included those participants who received at least one dose of study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||participants|||Number
2704742|NCT01209949|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.|Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.|Week 12|Modified ITT (subjects with a baseline and week 12 visit)|||percent change from baseline||Standard Deviation|Mean
2704727|NCT01210144|Secondary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
2704728|NCT01210144|Secondary|Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
2704729|NCT01210144|Primary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"Intention-to-Treat (ITT) population: participants who received at least 1 dose of study drug. N (number of participants analyzed) signifies participants evaluable for this measure. Results for both agonist and antagonist protocol are presented as total since assessment of histological pattern for whole study population was the primary objective."|||participants|||Number
2704730|NCT01210144|Primary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®|A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed for both agonist and antagonist protocol as total, which was the primary objective, since gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
2704731|NCT01210118|Secondary|Days of Prematurity of Birth|Days of prematurity of birth were recorded|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.|||number of days||Standard Deviation|Mean
2704732|NCT01210118|Primary|The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.|The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.|At the baseline and at the 32nd week of gestation||||percentage of participants who quit|||Number
2704733|NCT01210118|Secondary|Birth Weight|Infants' birth weight was recorded.|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.|||birth weight in grams||Standard Deviation|Mean
2704734|NCT01210118|Primary|Participants' Smoking Status|participants' smoking status was validated by urine cotinine and urine nicotine|around the 32nd week of gestation.|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis|||ng/ml||Standard Deviation|Mean
2704735|NCT01210079|Primary|Change in Pain Threshold Time From Baseline to Week 5|Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.|baseline, 5 weeks||||seconds||Standard Error|Mean
2704736|NCT01210001|Other Pre-specified|Hypoglycaemic Events|Number of patients with hypoglycaemic events, as reported as adverse events.|From first drug administration until 7 days after last intake of study drug, up to 256 days|Treated set which included all patients treated with at least one dose of randomised study medication|||percentage of participants|||Number
2704737|NCT01210001|Primary|HbA1c Change From Baseline for Pio and Met Background Medication Patients|"Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value for patients on pioglitazone and metformin background medication. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
2704738|NCT01210001|Secondary|Body Weight Change From Baseline|"Change from baseline in body weight after 24 weeks.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||kg||Standard Error|Mean
2704739|NCT01210001|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|"Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mg/dL||Standard Error|Mean
2704740|NCT01210001|Primary|HbA1c Change From Baseline|"Change From Baseline in HbA1c after 24 weeks.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
2704743|NCT01209949|Primary|Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12|Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.|12 weeks|Modified ITT (subjects with a baseline and week 12 visit)|||participants|||Number
2704744|NCT01209832|Secondary|Tasisulam Pharmacokinetics: Area Under the Concentration-Time Curve Above the Albumin Corrected Threshold (AUCalb)|Tasisulam is highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) tasisulam.|Period 2: Predose, preinfusion start, 1, 1.75, 2 (post end of infusion), 2.5, 3, 4, 6, 8, 24, 48, 72, 120, 168, and 336 hours.|All participants who received tasisulam and had pharmacokinetics data.|||hour*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2704745|NCT01209832|Secondary|Tasisulam Pharmacokinetics: Maximum Concentration (Cmax)||Period 2: Predose, preinfusion start, 1, 1.75, 2 (post end of infusion), 2.5, 3, 4, 6, 8, 24, 48, 72, 120, 168, and 336 hours.|All participants who received tasisulam and had pharmacokinetics data.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2704746|NCT01209832|Secondary|Number of Participants With Tumor Response|Number of participants with tumor response = number of participants with complete response (CR) + number of participants with partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Baseline to Day 15 of Maintenance Period up to 3 months|All participants who received study drug.|||Participants|||Count of Participants
2704747|NCT01209832|Primary|Midazolam Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0-infinity)||Period 1 and 2: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 9, 11, 24, 48, and 72 hours post-dose.|All participants who received study drug and had sufficient pharmacokinetics data to calculate AUC0-infinity. Analysis used data according to the treatment the participants actually received.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2704748|NCT01209832|Primary|Midazolam Pharmacokinetics: Maximum Concentration (Cmax)||Period 1 and 2: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 9, 11, 24, 48, and 72 hours post-dose.|All participants who received study drug and had sufficient pharmacokinetics data to estimate Cmax. Analysis used data according to the treatment the participants actually received.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2704749|NCT01209832|Primary|Midazolam Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With Measurable Concentrations (AUC 0-tlast)||Period 1 and 2: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 9, 11, 24, 48, and 72 hours post-dose.|All participants who received study drug and had sufficient pharmacokinetics data to calculate AUC0-tlast. Analysis used data according to the treatment the participants actually received.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2704750|NCT01209780|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.|Day 1 to 180 (non-naive )/Day 1 to 209 (naive)|Analysis was done on the safety set population.|||Subjects|||Number
2704751|NCT01209780|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.|Day 1 to 7 after vaccination|Analysis was done on the safety set population i.e all subjects who received at least one study vaccine and provided post vaccination safety data.|||Subjects|||Number
2704752|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).~This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain."|Day 29 and Day 50|Analysis was done on the per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2704753|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.|"The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).~This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain."|Day 1, Day 29, and Day 50|Analysis was done on the per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2704754|NCT01209780|Secondary|Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.~This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40."|Day 22 for non-naive/Day 50 for naive|Analysis was performed on the per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2704755|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)|The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on the per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2704756|NCT01209780|Secondary|Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.|"The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.~This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%."|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2704757|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion|"The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.~Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer"|Day 22 for non-naive/Day 50 for naive subjects|Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.|||Percentages||95% Confidence Interval|Number
2704758|NCT01209767|Primary|Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.|"Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom Cryolipolysis or Subcision resulted in the best cosmetic appearance. It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better."|12 weeks||||Percentage of participants||90% Confidence Interval|Number
2704759|NCT01209702|Secondary|Part 1: The Number of Participants With Adverse Events|A serious adverse event (AE) is any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one or other of the outcomes listed above. The intensity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. A severe AE was any event of Grade 4 (life-threatening consequences; urgent intervention indicated) or 5 (death related to AE).|Up to 40 weeks|The safety analysis population included all patients who received at least one tocilizumab/placebo infusion and had at least one postdose safety assessment. Patients were assigned to treatment groups as treated for analysis.|||participants|||Number
2704760|NCT01209702|Secondary|Part 2: Percentage of Participants With a Reduction of Magnetic Resonance Imaging (MRI) Proven Spinal Inflammation|Magentic resonance imaging of the axial skeleton was to be performed at Baseline and Week 24. MRI scans will be evaluated using the ankylosing spondylitis spinal MRI activity (ASspiMRI-a) score, grading activity (0-6) per vertebral unit in 23 units.|Baseline and Week 24|Due to premature study termination this outcome measure was not analyzed.||||||
2704761|NCT01209702|Secondary|Part 2: Radiographic Change According to the Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)|"Radiographs were to be assessed using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where:~0 = No abnormality;~1 = Erosion, sclerosis, or squaring;~2 = Syndesmophyte;~3 = Total bony bridging at each site."|Baseline and Week 104|This outcome measure was not analyzed due to premature study termination.||||||
2704762|NCT01209702|Primary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.|||percentage of participants|||Number
2704763|NCT01209702|Secondary|Number of Participants With Anti-tocilizumab Antibodies|A positive anti-tocilizumab antibody result was defined as a negative assay result at Baseline and a positive post-baseline screening assay with positive confirmation or neutralizing assay at the same visit.|From Baseline until end of study (a maximum treatment duration of 40 weeks).|All patients treated with tocilizumab and screened for anti-tocilizumab antibodies at any timepoint.|||participants|||Number
2704764|NCT01209702|Secondary|Change From Baseline in Level of Soluble Interleukin-6 Receptor|"Soluble Interleukin-6 receptor levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.~The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic Population: All patients who received at least one tocilizumab infusion and had at least one pharmacokinetic and pharmacodynamic sample. Only those patients with available data at each time point are included in the analysis (indicated by N). Patients who did not receive their week 8 dose were excluded.|||ng/mL||Standard Deviation|Mean
2704933|NCT01208207|Primary|Number of Participants Discontinuing Study Treatment Due to an Adverse Event||Up to 26 weeks|All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.|||Participants|||Number
2704765|NCT01209702|Secondary|Change From Baseline in the Level of Interleukin-6|"Interleukin-6 levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.~The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic (PK) Population: All patients who received at least one tocilizumab infusion and had at least one PK and pharmacodynamic sample. Only patients with available data at each time point are included (indicated by N). Patients who did not receive their Week 8 dose were excluded.|||pg/mL||Standard Deviation|Mean
2704766|NCT01209702|Secondary|Part 2: Volume of Distribution of Tocilizumab|Volume of distribution of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
2704767|NCT01209702|Secondary|Part 2: Clearance of Tocilizumab|Clearance of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
2704768|NCT01209702|Secondary|Part 2: Elimination Half-life of Tocilizumab|Elimination half-life of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
2704769|NCT01209702|Secondary|Part 2: Peak Plasma Concentration of Tocilizumab|The peak plasma concentration (Cmax) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
2704770|NCT01209702|Secondary|Part 2: Area Under the Plasma Concentration Versus Time Curve of Tocilizumab|Area under the plasma concentration versus time curve (AUC) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
2704771|NCT01209702|Secondary|Change From Baseline in C-Reactive Protein|Levels of C-reactive protein (CRP) were measured from blood samples taken at Baseline and at Week 12.|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.|||mg/dL||Standard Deviation|Mean
2704772|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|"The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are:~Tragus-to-wall;~Modified Schober (lumbar flexion);~Cervical rotation;~Lateral spinal flexion;~Intermalleolar distance.~The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS."|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.|||scores on a scale||Standard Deviation|Mean
2704773|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The Bath Ankylosing Spondylitis Functional Index (BASFI) is an assessment of function in AS patients. The participant provides their assessment of their ability to perform 10 activities on a 100 mm horizontal visual analog scale (VAS) ranging from 0 (easy) to 100 (impossible). The BASFI score is the mean of these values and is tabulated on a 0 (best) to 10 (worst) cm scale.|Baseline and Week 12|Intent-to-treat population for whom data were available. The analysis was not performed for participants in Part 2.|||cm||Standard Deviation|Mean
2704774|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"The BASDAI is a patient-administered assessment of 6 parameters specific to AS. The following parameters were assessed on a 100-mm horizontal visual analogue: fatigue, spinal pain, peripheral arthritis, enthesitis, intensity of morning stiffness, and duration of morning stiffness. For questions 1 to 5, the left-hand extreme of the line (0) represents none (symptom-free) and the right-hand extreme (100) represents very severe (maximum severity). For question 6, a time axis was used, with the left-hand extreme of the line representing 0 hours and the right-hand extreme representing 2 or more hours. The BASDAI score was calculated as follows:~BASDAI = [Q1 + Q2 + Q3 + Q4 + (Q5 + Q6)/2]/5. The total score is tabulated on a scale from 0 (best) to 10 cm (worst)."|Baseline and Week 12|Intent-to-treat population where data were available.|||cm||Standard Deviation|Mean
2704775|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 24|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT), Part 2 study population. This analysis was not performed due to premature study termination.||||||
2704781|NCT01209624|Primary|Percentage of Participants With Progression of Visual Field|Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have had Visual Field Deterioration rated as progressive by the physician on at least 1 post-baseline visit, and at least one measure of increase in Aulhorn Stage by at least 1 stage, and decrease in Mean Defect by at least 2 dB (last visit minus baseline).|||Percentage of Participants|||Number
2704776|NCT01209702|Secondary|Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 12|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.|||percentage of participants|||Number
2704777|NCT01209702|Secondary|Percentage of Participants Who Achieved a Value <2 in Each of the 4 ASAS Parameters at Week 12|"Assessment in Ankylosing Spondylitis (ASAS) is composed of four domains.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), the mean of 10 self-assessment questions on a 100 mm VAS.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).~Each of the above 4 domains are measured on a scale from 0-100 mm, but reported on a 0-10 cm scale. A score of less than 2 units (20 mm) in each domain is defined as partial remission."|Week 12|Intent-to-treat. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.|||percentage of participants|||Number
2704778|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.|||percentage of participants|||Number
2704779|NCT01209702|Primary|Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|"Intent-to-treat (ITT) population included all patients who were randomized into the study and received at least one tocilizumab/placebo infusion.~If the response at the 12-week visit could not be determined due to early withdrawal or missing data then the patient was considered a non-responder."|||percentage of participants|||Number
2704780|NCT01209689|Primary|Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12|ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.|Baseline to Week 12|Intent-to-treat population: All randomized patients who received at least 1 dose of treatment. The analysis only included assessments while patients were receiving double-blind treatment and that occurred prior to withdrawal or the date when all patients were unblinded (15 Jul 2011). Patients who withdrew or escaped were considered non-responders.|||Percentage of patients|||Number
2704805|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 12|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.|||Participants|||Number
2704782|NCT01209624|Primary|Percentage of Participants With Progression of Optic Disc Excavation|Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of following events: increase in horizontal or vertical cup to disc ratio, or decrease in rim area, rim volume, or mean RNFL thickness. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Percentage of Participants|||Number
2704783|NCT01209624|Primary|Percentage of Participants With Overall Progression of Glaucoma Damage|Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels [dB])|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of the six individual progression of glaucoma damage measures. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Percentage of Participants|||Number
2704784|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect|Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value for mean defect at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
2704785|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage|Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.|Month 24 (or last visit)|PP; results based on participants with a value for Aulhorn Stage at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
2704786|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration|Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of change in visual field defect. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
2704787|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness|Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value of the variable in question at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
2704788|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage|Participants with at least one post-baseline optic disc hemorrhage.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of optic disc hemorrhage. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Particpants|||Number
2704789|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio|Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with both a Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
2704790|NCT01209624|Primary|Number of Participants With Investigator Assessments of Efficacy at Month 24|Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.|Month 24|PP; N = number of participants with a non-missing response at Month 24 visit.|||Participants|||Number
2704791|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Visual Field Defect|Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: < -2 dB and ≥ -3.3 dB; moderate damage: < -3.3 dB and ≥ -4.6 dB; and severe damage: < -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided a Mean Defect value at both Baseline and Month 24 visits.|||Participants|||Number
2704792|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages|Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided Aulhorn stage values of 1 to 5 at both baseline and month 24 visits.|||Participants|||Number
2704806|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 24|PP; N = number of participants with analyzable data at observation.|||Participants|||Number
2704793|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness|Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for RNFL thickness.|||mm||Standard Deviation|Mean
2704794|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure|Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for cup shape measure.|||Cup shape measure||Standard Deviation|Mean
2704795|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume|Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim volume.|||mm3||Standard Deviation|Mean
2704796|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area|Rim area (millimeter [mm]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim area.|||mm2||Standard Deviation|Mean
2704797|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 24|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 24|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
2704798|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 18|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 18|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
2704799|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 12|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 12|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
2704800|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 6|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 6|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
2704801|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP. N = number of participants with vertical cup to disc ratio at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in vertical cup to disc ratio in participants with a non-missing response at both baseline and at least one post-baseline visit.|||Ratio||Standard Deviation|Mean
2704802|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; N = number of participants with horizontal cup to disc ratio data at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in participants with a non-missing response at both baseline and at least one post-baseline visit.|||Ratio||Standard Deviation|Mean
2704803|NCT01209624|Primary|Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit|Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.|Month 24, (or last visit)|PP; n = number of subjects in the Per Protocol Analysis Set with a non-missing response at Last Visit. Last visit = last post-baseline visit at which participant provides a value of IOP.|||Percentage of Participants|||Number
2704804|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 24|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.|||Participants|||Number
2704807|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 12|PP; N = number of participants with analyzable data at observation.|||Participants|||Number
2704808|NCT01209624|Primary|Change From Baseline in Raw Intraocular Pressure (IOP) by Visit|Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|Per protocol (PP) analysis set: all participants in the Full Analysis Set (at least 1 dose of Xalatan® and 1 post-baseline IOP measurement) who were treated for ≥18 months; had at least BL and 1 post-BL non-missing efficacy assessments for IOP at least 18 months apart; without ametropy at BL; and without additional glaucoma medication during study.|||mmHg||Standard Deviation|Mean
2704809|NCT01209598|Secondary|Best Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||Participants|||Count of Participants
2704810|NCT01209598|Primary|Progression Free Survival at 12 Weeks|PFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib|12 weeks||||percentage of particpants||95% Confidence Interval|Median
2704811|NCT01209520|Primary|Degree of Demethylation in Patient Tumor Tissue and/or Serum Induced by 5-azacitidine on Specific Tumor Specific Genes (TSGs)|To measure the grade of demethylation induced by 5-azaciditine on specific TSGs by analyzing plasma DNA, and global demethylation by analyzing WBC DNA, and determine the duration of this effect.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.||||||
2704812|NCT01209520|Primary|Percentage of Patients Showing a Presence of Methylated Tumor Suppressor Genes in Their Tumor Tissue and/or Serum Achieving Partial or Complete Response to Protocol Therapy.|To determine the feasibility and efficacy of incorporating a demethylating agent (5-azacitidine; Vidaza®, Celgene, Summit, NJ, USA) as part of adjuvant therapy in patients diagnosed with NSCLC who harbor methylated tumor supressor genes (TSGs) in their tumor tissue and/or serum. Response to be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.0.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.||||||
2704813|NCT01209442|Secondary|Overall Survival, Measured From the Day of Initial Diagnosis (Biopsy or Surgery) to the Time of Death From Any Cause.||follow up for life||||months||95% Confidence Interval|Median
2704814|NCT01209442|Primary|6-month Progression-free Survival|To use 6-month progression-free survival to assess the efficacy of the combination of hypofractionated IMRT delivering 60 Gy over 2 weeks with concurrent bevacizumab and temozolomide followed by 6 cycles of adjuvant bevacizumab and temozolomide.|6 months||||months||95% Confidence Interval|Median
2704815|NCT01209286|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) is 125 pg/mL and the limit of detection (LOD) is 20 pg/mL.|Samples were collected prior to treatment start (baseline), and at 2, 6, 24, and 48 hours after drug infusion start, and at these same time points when dose is escalated in each treatment cycle.|Participants who received blinatumomab and who had evaluable pharmacodynamic data.|||pg/mL||Standard Deviation|Mean
2704816|NCT01209286|Secondary|Clearance of Blinatumomab|Clearance was calculated as R0/Css; where R0 is the infusion rate (μg/m^2/hr) and Css is the steady state concentration.|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.|||L/m^2/hr||Standard Deviation|Mean
2704817|NCT01209286|Secondary|Steady State Blinatumomab Concentration|"The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the intravenous infusion was started for cycle 1 and cycle 2, respectively. Actual doses administered were used in the analysis.~Concentrations below the limit of detection (3 pg/mL) were set to zero before data analysis and concentrations below the lower limit of quantitation (50 pg/mL) were excluded from analysis."|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.|||pg/mL||Standard Deviation|Mean
2704818|NCT01209286|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 and according to the following:~Grade I (mild); Grade 2 (moderate); Grade 3 (severe - significantly limits the patient's ability to perform routine activities despite symptomatic therapy; Grade 4 (life-threatening); Grade 5 (death).~The investigator used medical judgment to determine if there was a causal relationship (ie, certain, probable, possible, unlikely, not related) between an adverse event and blinatumomab.~A serious adverse event is any untoward medical occurrence or effect, that at any dose:~resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically important condition."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle; median treatment duration was 55.7 days.|Safety analysis set, defined as all participants who received any infusion of blinatumomab.|||participants|||Number
2704819|NCT01209286|Secondary|Overall Survival|Overall survival was measured for all participants from the date of first infusion of blinatumomab until the date of death due to any cause. Participants who did not die were censored on the last documented visit date. Overall survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 667 days.|Full analysis set|||days||95% Confidence Interval|Median
2704831|NCT01209260|Primary|Transseptal Access Procedure Time|Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.|Day of procedure||||minutes||Inter-Quartile Range|Median
2704820|NCT01209286|Secondary|Relapse-free Survival|Relapse-free survival was measured only for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse-free survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.|||days||95% Confidence Interval|Median
2704821|NCT01209286|Secondary|Time to Hematological Relapse|"Time to hematological relapse was measured for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their day of death.~Hematological Relapse was defined as:~Proportion of blasts in bone marrow > 5%~Extramedullary relapse.~Time to hematological relapse was analyzed by Kaplan-Meier methods."|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.|||days||95% Confidence Interval|Median
2704822|NCT01209286|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab|The percentage of participants who underwent immediate allogeneic HSCT (defined as those in remission who undergo HSCT without receiving any other treatments) after having discontinued or completed the core study.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days|Full analysis set|||percentage of participants|||Number
2704823|NCT01209286|Secondary|Percentage of Participants With a Minimal Residual Disease (MRD) Response During the Core Study|A minimal residual disease (MRD) response is defined as MRD < 10^-4 blasts/nucleated cells based on polymerase chain reaction (PCR) evaluation of individual rearrangements of immunoglobulin or T cell receptor genes.|During the core study treatment period (up to 30 weeks).|Full analysis set (FAS)|||percentage of participants||95% Confidence Interval|Number
2704824|NCT01209286|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Partial remission was defined by the following criteria:~• Bone marrow blasts ≤ 25%"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2704825|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete remission with only partial hematological recovery (CRh*) was defined by the following criteria:~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Partial recovery of peripheral blood counts:~Platelets > 50,000/μL~Hemoglobin ≥ 7 g/dL~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2704826|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete Response/Remission (CR) was defined by the following criteria:~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Full recovery of peripheral blood counts:~Platelets > 100,000/μL~Hemoglobin ≥ 11 g/dL~Absolute neutrophil count (ANC) > 1,500/μL"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2704827|NCT01209286|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Hematological remissions were defined by the following criteria:~Complete Response/Remission (CR):~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Full recovery of peripheral blood counts:~Platelets > 100,000/μL~Hemoglobin ≥ 11 g/dL~Absolute neutrophil count (ANC) > 1,500/μL~Complete Remission with only Partial Hematological Recovery (CRh*):~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Partial recovery of peripheral blood counts:~Platelets > 50,000/μL~Hemoglobin ≥ 7 g/dL~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set (FAS), defined as participants who received any infusion of the assigned study medication, who completed at least the first treatment cycle and for whom at least one response assessment was available after the start of treatment.|||percentage of participants||95% Confidence Interval|Number
2704828|NCT01209260|Secondary|Plastic Dilator Shavings|In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.|immediately prior to procedure|The assigned needle for each participant was analyzed prior to the procedure|||Needles|Participants||Number
2704829|NCT01209260|Secondary|Performance of the Assigned Needle Type|Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.|at time of procedure||||participants|||Number
2704830|NCT01209260|Secondary|Number of Participants With Adverse Events as a Measure of Safety||During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.||||participants|||Number
2704833|NCT01209195|Secondary|Pharmacokinetic Parameters (AUClast)|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).~Immunogenicity data is not available."|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
2704834|NCT01209195|Secondary|To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2704835|NCT01209195|Secondary|To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 163 weeks||||participants with objective response|||Number
2704836|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.~Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|note: MTD of MM-121 when administered in combination with paclitaxel provided in separate endpoint entry|||mg/m2|||Number
2704837|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.~Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|NOTE: MTD of paclitaxel when administered with MM-121 provided in separate endpoint entry|||mg/kg|||Number
2704838|NCT01209195|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)|To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 163 weeks||||participants reporting DLTs|||Number
2704839|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of Cmax of ethinyl estradiol and norethindrone were defined as the ratios of Cmax of ethinyl estradiol and norethindrone on Day 8 divided by Cmax of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL||90% Confidence Interval|Number
2705073|NCT01206816|Secondary|Number of Patients With Drug-related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Criteria v 3.0|Number of patients with investigator defined drug-related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria v 3.0|After the first drug administration until 28 days after the last drug administration, up to 413 days.|Treated Set (TS)|||participants|||Number
2704840|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of AUC(0-inf) of ethinyl estradiol and norethindrone were defined as the ratios of AUC(0-inf) of ethinyl estradiol and norethindrone on Day 8 divided by AUC(0-inf) of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL*hr||90% Confidence Interval|Number
2704841|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of Cmax of rosiglitazone was defined as the Cmax of rosiglitazone on Day 8/ Cmax of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL||90% Confidence Interval|Number
2704842|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of AUC(0-inf) of rosiglitazone was defined as the AUC(0-inf) of rosiglitazone on Day 8/AUC(0-inf) of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL*hr||90% Confidence Interval|Number
2704843|NCT01209078|Secondary|Population Pharmacokinetic Parameters of Apparent Total Clearance of GSK1322322 From Plasma After Oral Administration (CL/F)|Blood samples were planned to be collected on Day 1, 0.25-1.5 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and 1.5-3 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and Day 4, 4-12 hours post-morning dose (corresponding to the safety laboratory and ECG timepoint), and Day 8, pre-morning dose (corresponding to safety laboratory and ECG timepoint) during the outpatient visit. The data for this outcome measure was not collected and assessed.|Day 1 (0.25-1.5 hours post-initial dose, 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose) and Day 8 (pre-morning dose)|Pharmacokinetic (PK) Concentration Population defined all Participants in the “Safety Population” who underwent plasma PK sampling during the study and from whom a measurable plasma concentration above the assay’s limit of quantification were obtained for one of the treatment regimens. No participants were analyzed for this outcome measure.||||||
2704844|NCT01209078|Secondary|Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline|Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0. The pathogens isolated at Baseline included staphylococcus aureus (methicillin-resistant staphylococcus aureus [MRSA] and methicillin-susceptible staphylococcus aureus [MSSA] as defined by susceptibility to cefoxitin or oxacilin), streptococcus pyogenes, other streptococcus species, other Gram-positive pathogens and Gram-negative pathogens. Data is categorized for the percentage of participants with clinical success for each of the pathogens, all pathogens and no pathogens.|Up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2704845|NCT01209078|Secondary|Mean Change From Baseline in Wound Area at Indicated Time Points|The area of the infected lesion size was calculated as the product between the length (L) and width (W) of the lesion size. The wound was measured by the investigator in centimeters (cm), using a standard metric ruler. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||cm^2||Standard Deviation|Mean
2704846|NCT01209078|Secondary|Mean Change From Baseline in Total SIS at Indicated Time Points|The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline ) up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2704847|NCT01209078|Secondary|Mean Total SIS at Indicated Time Points|The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.|Up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2704848|NCT01209078|Secondary|Mean Exudate or Pus Sub-score of SIS at Indicated Time Points|The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The exudate or pus sub-score of SIS was rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.|Up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2704849|NCT01209078|Secondary|Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points|SF-MPQ-2 is composed of 22 items that describes different quantities of pain and related symptoms. Sub-score of continuous pain represents mean of throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain and tender (mean of items 1, 5, 6, 8, 9 and 10). Sub-score of intermittent pain represents mean of shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain and piercing (mean of items 2, 3, 4, 11, 16 and 18). Sub-score of neuropathic pain represents mean of hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles, numbness (mean of items 7, 17, 19, 20, 21 and 22). Sub-score of affective descriptors represents mean of tiring-exhaustive, sickening, fearful, punishing-cruel (mean of items 12, 13, 14 and 15). Scores ranged from 0 to 10, where 0 indicated absence of symptom and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up.|Up to Follow-up (7 Day Follow up, Day 19)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2704850|NCT01209078|Secondary|Percentage of Participants With Therapeutic Success of Therapeutic Outcome|Therapeutic outcome was combined clinical and microbiological outcome. Therapeutic outcome was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic outcome. Therapeutic outcome was determined programmatically, obtained at 7 day Follow-up.|Follow-up (7 day Follow-up, Day 19)|Per Protocol Bacteriology (PPB) Population was defined as ITTB participants who adhered to protocol-specific criteria (i.e., no protocol violation ): taking 80% of medications and/or not missing more than 48 h in a row of study drug, and have both end of therapy and 7 day Follow-up to be evaluable and a documented pathogen cultured at Baseline.|||Percentage of participants||95% Confidence Interval|Number
2704851|NCT01209078|Secondary|Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up|The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to culture results at Follow-up (Day 16-19), and corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: Baseline pathogen was eradicated or presumed eradicated at end of therapy, or Baseline pathogens were present at end of therapy and is absent at Follow-up (microbiological eradication in microbiological response); Baseline pathogen was eradicated or presumed eradicated at end of therapy, or the Baseline pathogens were present at end of therapy and, participant was a 'clinical success', such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the eCRF (microbiological eradication); a new pathogen, not previously identified at Baseline, was identified at Follow-up in a participant who was a 'clinical success' (colonization)|Follow-up (7 Day Follow-up, Day 19)|ITTB Population.|||Percentage of participants|||Number
2704852|NCT01209078|Secondary|Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy|The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to the culture results at the end of therapy (visit window of Day 12-14), and the corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: elimination of Baseline pathogens (defined as microbiological eradication in microbiological response); clinical outcome was success such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the electronic case report form (eCRF) (defined as presumed microbiological eradication in microbiological response); new pathogen not previously identified, was identified at end of therapy in a participant who was a 'clinical success' (defined as colonization in microbiological response).|Day 11 (end of therapy)|Intent-to-Treat Bacteriology (ITTB) Population was defined as all randomized participants who received at least one dose of study medication and who had a pathogen isolated at Baseline.|||Percentage of participants|||Number
2704853|NCT01209078|Secondary|Percentage of Participants With Clinical Success of Clinical Outcome|The clinical response was determined by the investigator after clinical evaluation of reviewing clinical signs and symptoms at end of therapy (within 3 days post therapy; visit window of Day 12-14) and 7 day Follow-up ( visit window of Day 16 to 19), and the resulting clinical outcome was assigned, for each participant. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0.|Day 11 (end of therapy) and Follow-up (7 Day Follow-up, Day 19)|ITTC Population.|||Percentage of participants|||Number
2704871|NCT01209078|Primary|Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points|Blood samples were obtained for analysis of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC and platelet count at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Giga cells/Liter||Standard Deviation|Mean
2704854|NCT01209078|Secondary|Number of Participants With Clinical Success of Clinical Response|The clinical response was evaluated by the investigator at end of therapy (within 3 days post therapy; Day 12-14) and Follow-up (7 day Follow-up; Day 16 to 19 and 28 day Follow-up; Day 37 to 40). Clinical response was determined after clinical evaluation of reviewing clinical signs and symptoms. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudate skin infection score (SIS) of 0.|Up to Follow-up (28 Day Follow-up, Day 40)|Intent-to-Treat Clinical (ITTC) Population was defined as all randomized participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2704855|NCT01209078|Primary|Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range|The parameters of clinical chemistry included basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC count, platelet count, MCV, hemoglobin, MCHC, MCH, RBC count and reticulocyte count. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.|Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2704856|NCT01209078|Primary|Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range|The parameters of clinical chemistry included albumin, total protein, ALT, ALP, AST, GGT, LDH and creatine kinase, creatinine, uric acid, direct bilirubin, total bilirubin, glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN and high sensitivity C-Reactive protein. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.|Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2704857|NCT01209078|Primary|Mean Change From Baseline in ECG Rhythms at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The value recorded pre-dose on Day 1 was the Baseline. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.|Day 1 (pre-dose, Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2704858|NCT01209078|Primary|Mean ECG Rhythms at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour).|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2704859|NCT01209078|Primary|Mean Change From Baseline in ECG Values at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). Mean value recorded pre-dose on Day 1 was classified as Baseline. Change from Baseline was calculated by subtracting the Baseline value from individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.|Day 1 (pre-dose, Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
2704860|NCT01209078|Primary|Mean Electrocardiogram (ECG) Values at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The mean value recorded pre-dose on Day 1 was classified as Baseline.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
2704872|NCT01209078|Primary|Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points|Blood samples were obtained for analysis of high sensitivity C-Reactive protein at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (7 Day Follow-up, Day 19)|Safety Population. Only those participants available at the specified time points were analyzed.|||mg/Liter||Standard Deviation|Mean
2704861|NCT01209078|Primary|Mean Change From Baseline in RR at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2704862|NCT01209078|Primary|Mean Change From Baseline in HR at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2704863|NCT01209078|Primary|Mean Change From Baseline in SBP and DBP at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2704864|NCT01209078|Primary|Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2704865|NCT01209078|Primary|Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2704866|NCT01209078|Primary|Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2704867|NCT01209078|Primary|Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points|Blood samples were obtained for analysis of RBC count and reticulocyte at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Trillion cells (TI)/Liter||Standard Deviation|Mean
2704868|NCT01209078|Primary|Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points|Blood samples were obtained for analysis of MCH at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Picogram||Standard Deviation|Mean
2704869|NCT01209078|Primary|Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points|Blood samples were obtained for analysis of MCHC at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram/Liter||Standard Deviation|Mean
2704870|NCT01209078|Primary|Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points|Blood samples were obtained for analysis of MCV at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
2704873|NCT01209078|Primary|Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point|Blood samples were obtained for analysis of estradiol at Day 1.|Day 1|Safety Population. Only those participants available at the specified time points were analyzed.|||Picomole (pmol)/Liter||Standard Deviation|Mean
2704874|NCT01209078|Primary|Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points|Blood samples were obtained for analysis of glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole (mmol)/Liter||Standard Deviation|Mean
2704875|NCT01209078|Primary|Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points|Blood samples were obtained for analysis of creatinine, uric acid, direct bilirubin and total bilirubin at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromoles (µmol)/liter||Standard Deviation|Mean
2704876|NCT01209078|Primary|Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points|Blood samples were obtained for analysis of ALT, ALP, AST, FSH, GGT, LDH and creatine kinase at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||International units (IU)/Liter||Standard Deviation|Mean
2704877|NCT01209078|Primary|Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points|Blood samples were obtained for analysis of albumin and total protein at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram/Liter||Standard Deviation|Mean
2704878|NCT01209078|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population was defined as all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2704879|NCT01208961|Primary|C(Max): Maximum Plasma Concentration|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.||||nmol/mL||Full Range|Geometric Mean
2704880|NCT01208961|Primary|AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.||||nmol.h/mL||Full Range|Geometric Mean
2704881|NCT01208961|Primary|AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.||||nmol.h/mL||Full Range|Geometric Mean
2704882|NCT01208922|Secondary|Number of Patients With Clinical Cure|Clinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without symptoms of enteric infection.|5 days||||Participants|||Count of Participants
2704883|NCT01208922|Primary|Time to Last Unformed Stool (TLUS)|Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.|5 days|Efficacy results were reported for Full Analysis Set, which all randomised patients (as randomised) who received at least one dose of study medication. Patients with uncertainty as to whether they had received study medication or not (e.g., due to lost to follow-up) were included.|||hours||95% Confidence Interval|Median
2704884|NCT01208870|Secondary|Changes in Variety Measures|Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density. Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly. Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low. These foods contribute little nutrients to the diet and compete for consumption of healthier foods. Green foods are high in nutrient density and low in energy density. Most Green foods come from the fruit and vegetable groups. Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes. Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.|Baseline to 6 months|Parents and children were measured, three families did not complete the dietary measures.|||food items||Standard Deviation|Mean
2705089|NCT01206608|Secondary|Number of Participants With Adverse Events|Adverse events were monitored through Day 8 and serious adverse events through Day 30.|Through 30 days postdose|||||||
2704885|NCT01208870|Secondary|Change in Child Delay Discounting|Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).|Baseline to 6 months|Children that completed this measure at pre and post time points. Eleven children did not complete the post measure.|||k value||Standard Deviation|Mean
2704886|NCT01208870|Secondary|Change in Parent Delay Discounting|Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values. (0.25 impulsive to 0.00016 not impulsive)|Baseline to 6 months|Parents that completed this measure pre and post. Ten parents did not complete this post measure.|||k value||Standard Deviation|Mean
2704887|NCT01208870|Primary|Change Parent Body Composition|Parent Body Mass Index (kg/m^2) difference from baseline to 6 months|Baseline to 6 months|Parents|||kg/m^2||Standard Deviation|Mean
2704888|NCT01208870|Secondary|Change in Dietary Intake of Calories|Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed. The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.|Baseline to 6 months|Parents and children, three families did not complete the dietary measures.|||calories||Standard Deviation|Mean
2704889|NCT01208870|Primary|Change of Child Body Composition|Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.|Baseline to 6 months|Children that completed the reported measures. Two children did not complete the body composition measures from the experimental groups and four children from the control group did not complete this measure.|||percentage of weight||Standard Error|Mean
2704890|NCT01208415|Primary|Patients That Are Free From Patency-related Intervention|Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.|6 Months|Of the 37 patients available for analysis at 6 months, data was available for 34 patients.|||participants|||Number
2704891|NCT01208402|Secondary|Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg|Duration of postoperative hours 4 to 12 patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting BB group and in 16 cases in the Esmolol group.|||percentage of 8 hour interval||Inter-Quartile Range|Median
2704892|NCT01208402|Primary|Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.|Duration of postoperative hours 4 to 12 spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 9 hours. Vital signs are measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting beta blocker group and in 16 cases in the Esmolol group.|||percentage of 8 hour interval||Inter-Quartile Range|Median
2704893|NCT01208402|Secondary|Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg|Duration of postoperative first three hours patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter.|end of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.|||percentage of 3 hour interval||Inter-Quartile Range|Median
2704894|NCT01208402|Primary|Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm|Duration of postoperative first three hours spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 3 hours. Vital signs are measured from end of surgery to 3 hours postoperatively at 5 minute intervals for the first hour and every 15 minutes thereafter.|End of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.|||percentage of 3 hour interval||Inter-Quartile Range|Median
2704895|NCT01208402|Secondary|Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg|Duration of intraoperative case time patient was not in the target window of SBP > 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.|||percentage of surgery minutes||Inter-Quartile Range|Median
2705253|NCT01205581|Secondary|Comparison of Geometric Mean Titer (GMT) by HAI|Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||Titers||Full Range|Geometric Mean
2704896|NCT01208402|Primary|Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm|Duration of intraoperative excursion (ie, time spent) outside Target HR range defined as 60 to 80 bpm during surgery, expressed as percent of case minutes. Vital signs are measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.|||percentage of case minutes||Inter-Quartile Range|Median
2704897|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|5 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.|||participants|||Number
2704898|NCT01208337|Secondary|Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.|Tacrolimus whole blood concentrations less than 10 ng/ml|1 year|It is believed that patients whom received Alemtuzumab at the time of transplant and continue post-transplant with functioning grafts will have Tacrolimus whole blood concentrations less than 10ng/ml.|||participants|||Number
2704899|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|1 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.|||participants|||Number
2704900|NCT01208337|Secondary|Incidence of Biopsy-proven Acute Cellular Rejection|Biopsy-proven incidence of acute cellular rejection|1 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).|||participants|||Number
2704901|NCT01208337|Primary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)|Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.|5 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).|||participants|||Number
2704902|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.|||blocks moved per minute||Standard Error|Least Squares Mean
2704903|NCT01208233|Other Pre-specified|Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
2704904|NCT01208233|Other Pre-specified|Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)||Day 1 (Baseline) up to Day 14|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
2704905|NCT01208233|Other Pre-specified|Number of Participants With Neuro-worsening (Part 2)|NIHSS change of 4 points or greater.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
2704906|NCT01208233|Other Pre-specified|Mortality Directly Related to Stroke (Part 2)|Deaths caused by stroke were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
2704907|NCT01208233|Other Pre-specified|All-cause Mortality (Part 2)|Deaths regardless causality were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
2704908|NCT01208233|Secondary|Plasma Concentrations of PF-03049423 (Part 1 and 2)||Days 1, 2, 7, 14, 30, 60 and 90|PK concentration population included all participants who were treated with PF-03049423 who had at least 1 measurable concentration. n=participants with concentration above lower limit of quantification at the corresponding sampling time.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2709326|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2704909|NCT01208233|Secondary|Gait Velocity Test at Day 90 (Part 2)|"The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk at a comfortable pace at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant's limb crossed the first marker and stopping the stopwatch as soon as the participant's limb crossed the second marker."|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||meters/second (m/s)||Standard Error|Least Squares Mean
2704910|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)|This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||pictures correctly identified||Standard Error|Least Squares Mean
2704911|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated participants included for comparison between active drug and placebo for this outcome measure.|||change in ratio||Standard Error|Least Squares Mean
2704912|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo for this outcome measure.|||change in percentage of lines crossed||Standard Error|Least Squares Mean
2704913|NCT01208233|Secondary|Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)|This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||objects named correctly||Standard Error|Least Squares Mean
2704914|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)|The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||correct responses||Standard Error|Least Squares Mean
2704915|NCT01208233|Secondary|BI at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||unit on a scale||Standard Error|Least Squares Mean
2705254|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After Second Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination||||Events|||Number
2704916|NCT01208233|Secondary|Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).|||percentage of participants|||Number
2704917|NCT01208233|Secondary|Change From Baseline in NIHSS at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||unit on a scale||Standard Error|Least Squares Mean
2704918|NCT01208233|Secondary|Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).|||percentage of participants|||Number
2704919|NCT01208233|Secondary|Percentage of Participants With mRS (0-1) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).|||percentage of participants|||Number
2704920|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated those participants included for comparison between active drug and placebo.|||percentage change||Standard Error|Least Squares Mean
2704921|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.|||pounds||Standard Error|Least Squares Mean
2704922|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.|||percentage change||Standard Error|Least Squares Mean
2704930|NCT01208233|Primary|Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated number of participants evaluated.|||participants|||Number
2704931|NCT01208220|Primary|Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)||2 weeks into study||||Percentage of red granulation tissue|||Number
2704932|NCT01208220|Secondary|Removal of Harmful Fluids in the Wound Tissue||2 weeks into study||||percentage of cytotoxins removed|||Number
2704923|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.|||blocks moved per minute||Standard Error|Least Squares Mean
2704924|NCT01208233|Primary|Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The Inferential Full Analysis Set (I-FAS) consisted of participants within the FAS who were randomized to PF-03049423 maximum tolerated dose (MTD) or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.|||percentage of participants|||Number
2704925|NCT01208233|Primary|Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)|"Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for any of above mentioned categories was assessed. *This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together."|Day 7 (Baseline) up to follow up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of participants who had C-SSRS assessed at that visit.|||participants|||Number
2704926|NCT01208233|Primary|Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)|The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had neurological examinations done at both baseline and last visit.|||participants|||Number
2704927|NCT01208233|Primary|Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)|The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had physical examinations done at both baseline and last visit.|||participants|||Number
2704928|NCT01208233|Primary|Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QT interval: >=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; absolute change 30 - <60, >=60 msec. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.|||participants|||Number
2704929|NCT01208233|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from grand baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine, sitting and standing): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.|||participants|||Number
2707267|NCT01192152|Secondary|Metformin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2704934|NCT01208207|Secondary|Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.|Week 6 to Week 10 and Week 12|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.|||mm VAS||95% Confidence Interval|Least Squares Mean
2704935|NCT01208207|Secondary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.|||mm VAS||95% Confidence Interval|Least Squares Mean
2704936|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.|||mm VAS||95% Confidence Interval|Least Squares Mean
2704937|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.|||mm VAS||95% Confidence Interval|Least Squares Mean
2704938|NCT01208181|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 12|ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of participants|||Number
2704939|NCT01208181|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 112 days|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of participants|||Number
2704940|NCT01208181|Secondary|Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed."|Week 6 and Week 10 to Week 12|This population (a subpopulation of the mITT population) was composed of pain inadequate responder (PIRs) in Part 1. PIRs were defined as participants with <50% improvement from baseline in Patient Global Assessment of Pain (VAS) at Week 6 and received at least one dose of study medication in Part 2.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2704941|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2705255|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After First Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination||||Events|||Number
2704942|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2704943|NCT01208181|Primary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2704944|NCT01208181|Primary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.|Baseline and Week 6|The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2704945|NCT01208103|Secondary|Number of Participants With Adverse Events|Toxicity was graded according to the NCI Common terminology Criteria for Adverse Events (CTCAE) 4.0 except for neurosensory and skin toxicity. Neurosensory toxicity was graded according to the Neurologic Toxicity Scale for Oxaliplatin Dose Adjustments.|39 months||||participants|||Number
2704946|NCT01208103|Secondary|To Determine the Overall Survival (OS) for CAPOX and Bevacizumab|The length of time interval in months from date of first treatment until the date of death or lost follow-up|39 months||||months||95% Confidence Interval|Median
2704947|NCT01208103|Secondary|To Determine the Overall PFS for CAPOX and Bevacizumab|Time interval in months from date of first treatment until the date of first documented progression|39 months||||months||95% Confidence Interval|Median
2704948|NCT01208103|Secondary|To Determine the Response Rate (RR) for CAPOX and Bevacizumab|Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)|39 months||||Participants|||Count of Participants
2704949|NCT01208103|Primary|Number of Participants With Progression-free Survival (PFS) at Six Months|A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.|6 months||||percentage of participants||95% Confidence Interval|Number
2704950|NCT01208038|Secondary|Libido - B-PFSF Score|Libido was assessed at each visit using the Brief profile of female sexual function (BPFSF), a validated self-administered questionnaire for identifying Hypoactive Sexual Desire Disorder (HSDD). The BPFSF is based on 7 questions. Each question is scored on a 6-point scale from 'always' to 'never'. A total score is total score ranging from 0 to 35. Previous studies have identified a score of less than 20 as suggestive of HSDD.|12 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2704951|NCT01208038|Secondary|Insulin Resistance - HOMA-IR|Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.|12 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2704952|NCT01208038|Primary|Endothelial Function|Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm. Official reference values do not exist however a lower RHI (<2.0) is usually considered indicative of endothelial dysfunction.|12 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2704953|NCT01208038|Primary|Arterial Compliance - Augmentation Index|Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0). The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function. The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure.|12 weeks from baseline||||percentage of Arterial stiffness||95% Confidence Interval|Mean
2704954|NCT01207934|Secondary|Post-treatment Plasma Leptin Levels|plasma leptin levels after fourteen days ingestion of either leptin or placebo.|fourteen days||||Micrograms/Liter||Standard Error|Mean
2704955|NCT01207934|Primary|Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.|This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|fourteen days||||mmol/kg body weight/minute||Standard Error|Mean
2704956|NCT01207934|Secondary|Baseline Plasma Leptin Concentrations|Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.|baseline||||Micrograms/Liter||Standard Error|Mean
2704957|NCT01207934|Primary|Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.|pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|baseline||||mmol/kg body weight/minute||Standard Error|Mean
2704958|NCT01207765|Secondary|Degree of CD20 Expression on Plasma Cells and/or Targeting of Post-germinal Center B Cells Correlation With Toxicity, Response and Biodistribution|CD20 immunohistochemical staining of plasma cells on baseline bone marrow biopsy specimen, graded on qualitative scale (0 to +++)|2 weeks prior - 2 weeks post transplant|Immunohistochemical analysis showed inconsistent / insufficient CD20 staining on surface of plasma cells; comparisons could not be made||||||
2704959|NCT01207765|Secondary|Time to Engraftment in Patients Who Proceed to Myeloablative Chemotherapy After Receiving 90Y Zevalin® (Ibritumomab Tiuxetan).|Number of days from stem cell infusion (day +0) to day of neutrophil engraftment (first of three consecutive days with absolute neutrophil count > 500)|Transplant through day 42|Analyzed on intent-to-treat basis|||Days||Full Range|Median
2704960|NCT01207765|Primary|Safety and Efficacy|Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.|Through day +104 following immunotherapy|6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety|||participants|||Number
2704961|NCT01207726|Secondary|Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0|Simple descriptive statistics will be utilized to display the data.|Up to 5 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704962|NCT01207726|Secondary|Presence of Methylation Patterns|McNemar's test will be used to compare the change in methylation after treatment in sputum.|Up to 2 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704963|NCT01207726|Secondary|Overall Survival|Determined by the method determined by Kaplan and Meier. Estimated with 95% confidence intervals. Cox proportional hazard modeling will be used for multivariate analysis.|Up to 5 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704964|NCT01207726|Secondary|Number of Relapses and Deaths Per Total Time of Follow-up Comparing Patients With N2 Lymph Nodes in Terms of Methylated and Unmethylated|Kaplan Meier curves will be used.|Up to 5 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704965|NCT01207726|Secondary|Median Disease-free Survival|Determined by the method determined by Kaplan and Meier. Estimated with 95% confidence intervals. Cox proportional hazard modeling will be used for multivariate analysis.|Up to 5 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704966|NCT01207726|Secondary|Factors That Predict Clinical Outcome in Patients Treated With Combination Epigenetic Therapy in Terms of Epigenomic Data Generated From the Illumina Platform|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. For this reason, 13 pts were enrolled and data was not analyzed, for which we are unable to make any conclusions or report results.|Up to 2 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704967|NCT01207726|Primary|Disease-free Survival (DFS)|The DFS hazard rate and 95% confidence interval will be reported. At this time, event time distributions for disease-free survival in the two arms will be estimated with the method of Kaplan and Meier and compared using a stratified Cox-proportional hazards model (stratified for stage IA vs IB) with a two-sided alpha of 10%.|3 years|The study was terminated early due to poor accrual since the requirement of clinic administration of the 5AZA daily and post-operative patients not wanting 6 months of treatment. Data was not collected to assess this outcome measure.||||||
2704968|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.|18 months|At this time point, one participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2705256|NCT01205581|Secondary|Number of Local Reactogenicity Events After Second Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination||||Events|||Number
2704969|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.|12 months|At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704970|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.|6 months|At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. One participant did not complete this questionnaire at this time point. Hence, data from 12 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704971|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.|baseline||||units on a scale||Full Range|Median
2704972|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|18 months|One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704973|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|12 months|At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704974|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|6 months|At this time point, one participant was off study due to adverse events and did not complete the questionnaire. Three participants did not complete the questionnaire at this time point. Hence, data from 10 participants were available for analysis.|||units on a scale||Full Range|Median
2704975|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Each response is recorded on an 11 point scale (0 - 10), with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score is reported for each subscale. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|baseline||||units on a scale||Full Range|Median
2704976|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|18 months|One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||T-score||Full Range|Median
2704977|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|18 months|One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704978|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|12 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||T-score||Full Range|Median
2705257|NCT01205581|Secondary|Number of Local Reactogenicity Events After First Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination||||Events|||Number
2704979|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|12 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704980|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|6 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||T-score||Full Range|Median
2704981|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 1 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|6 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
2704982|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|Baseline||||T-score||Full Range|Median
2704983|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|Baseline||||units on a scale||Full Range|Median
2704984|NCT01207687|Secondary|Percent Change in Median Vascular Permeability (Ktrans)|Correlation assessment were planned for imaging parameters and hearing response based on the estimated changes in Ktrans: a MRI measure of vascular permeability. Only 1/14 participants had complete Ktrans data that was amenable to analysis at baseline and week 72. Hence, these statistical analyses were not possible.|Baseline to week 72||||percent change in median Ktrans|||Number
2704985|NCT01207687|Secondary|Number of Participants With Changes in Function of the Auditory System|The primary distortion product optoacoustic emissions (DPOAE) measurement will be treated non-parametrically (present or absent across time) DPOAE's will be considered present at the frequency of F2 when the distortion product is 6dB above the noise floor. Variables will be analyzed for differences using t-tests if the effects and sample sizes warrant, but this may not be advisable given the small numbers to be accrued.|Baseline to 6 months post-treatment|Distortion product optoacoustic emissions (DPOEs) were only obtained for participants at the NCI site; thus, data from 5 participants were analyzed.|||Participants|||Count of Participants
2704986|NCT01207687|Secondary|Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI|The median percent change in the volume of the target vestibular schwannoma using volumetric MRI|Baseline to 12 months||||percentage of change in tumor volume||Full Range|Median
2704987|NCT01207687|Secondary|Radiographic Response|The proportion of participants with radiographic response as measured by a >/= 20% reduction in tumor volume from baseline on MRI imaging will be estimated using a binomial distribution.|Baseline to 6 months post-treatment||||participants||95% Confidence Interval|Number
2704988|NCT01207687|Secondary|Incidence of Serious or Life Threatening Toxicities|The number of patients with serious or life threatening toxicities (CTCAE grade 3 or above)|Up to 6 months post-treatment|Participants evaluated for serious or life threatening toxicities|||Participants|||Count of Participants
2704989|NCT01207687|Primary|Proportion of Patients With Hearing Response|A hearing response was defined as increased word recognition score above the 95% critical threshold that is maintained across two sequential evaluation time points. The word recognition score (WRS) is the percentage of phonetically-balanced, monosyllabic words that a patient can accurately repeat presented at either most comfortable level or most intelligible level.The proportion of patients with hearing response in the target ear was estimated using a binomial distribution along with 95% confidence intervals.|Baseline to 12 months|All people who underwent treatment were analyzed. Two patients stopped treatment early. One due to toxicity at week 25 and one due to need for medical care not permitted while on treatment at week 49.|||Proportion with hearing response||95% Confidence Interval|Number
2704990|NCT01207648|Secondary|Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Months||95% Confidence Interval|Median
2705274|NCT01205451|Secondary|Mean Change From Baseline in Pulse Rate at the Exit Visit|The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Screening) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||beats per minute||Standard Deviation|Mean
2704991|NCT01207648|Secondary|Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness. Annualized relapse rate was defined as number of attacks per year.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Attacks per year|||Number
2704992|NCT01207648|Primary|Number of Participants With Abnormal Laboratory Parameters|Laboratory parameters assessed for abnormality were: total white blood cell count (Neutrophils, Lymphocytes, Leukocytes, Monocytes, Eosinophils and Basophils), differential hematogram (Hematocrit, Erythrocytes, Hemoglobin, and Platelet), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and thyroid tests (including Triiodothyronine, Thyroxine, Thyroperoxidase Antibody and Thyroid-Stimulating Hormone). Due to the retrospective nature of the study, laboratory data should be interpreted with caution as data were not collected according to a specific time schedule and the time on study per participant was not standardized.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study. 'n' signifies number of participants who were evaluable for the specified categories.|||Participants|||Number
2704993|NCT01207648|Primary|Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®)|Medical events in the retrospective study are equivalent to adverse events in a prospective clinical study. A medical event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious medical event: A medical event that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants may be represented in more than one category as participant who had experienced serious medical event may also had experienced non-serious medical event reported by the Investigator as related to Rebif®, so in that case it will be counted in both the categories.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.|||Participants|||Number
2704994|NCT01207648|Primary|Number of Participants With Pre-specified Medical Events|These pre-specified medical events categories were evaluated: injections site reactions, flu-like symptoms, hepatic disorders, blood cell disorders, allergic reactions, epilepsy and convulsive disorders, thyroid dysfunction, autoimmune diseases, bone/epiphyseal and cartilage disorders, serious infections, malignancies. Each category defined by group of events which best fit the medical concept either using a standard medical dictionary for regulatory activities (MedDRA) Query (SMQ) e.g., Malignancies was defined by the SMQ Malignancies (narrow scope) containing more than 1800 different preferred terms (PTs) (including procedures and lab tests) or using a customized query, e.g., Serious infections was defined by all PTs assessed as serious in System Organ Class (SOC) Infections and Infestation. Participants may be represented in more than once in a category (Participants could have reported several medicals events pertaining to a specific category) as well as in more than one category.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.|||Participants|||Number
2704995|NCT01207596|Secondary|Global Assessment of Treatment Satisfaction|"Patients were asked to rate their global assessment of treatment satisfaction, ranging from very dissatisfied to very satisfied. Adverse events were monitored throughout the study"|Baseline visit to Week 12 or last visit|LOCF|||percentage of patients|||Number
2704996|NCT01207596|Secondary|Pain Quality Assessment Scale (PQAS)|The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain|Baseline visit to 12 weeks visit|LOCF|||units on a scale||Standard Error|Mean
2704997|NCT01207596|Secondary|Sleep Quality Assessment (SQA)|Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes)|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Deviation|Mean
2704998|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now|"Change from baseline to end of study on question #4 (current pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that tells how much pain you have right now, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Error|Mean
2704999|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours|"Change from baseline to end of study on question #4 (least pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Deviation|Mean
2705622|NCT01202253|Secondary|Percentage of Participants With Documented Eradication of Infecting Species|Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.|Baseline|Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants’ medical notes.||||||
2705000|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours|"Change from baseline to end of study on question #3 (worst pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Deviation|Mean
2705001|NCT01207596|Primary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale|"The primary efficacy measure was the change from baseline to end of study on question #5 (average pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain on the average, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Error|Mean
2705002|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 4|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.|||Percentage of participants|||Number
2705003|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 3|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.|||Percentage of participants|||Number
2705004|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 2|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.|||Percentage of participants|||Number
2705005|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 1|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.|||Percentage of participants|||Number
2705006|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 4|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.|||Percentage of participants|||Number
2705007|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 3|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.|||Percentage of participants|||Number
2705008|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.|||Percentage of participants|||Number
2705009|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.|||Percentage of participants|||Number
2705010|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 4|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.|||Percentage of participants||95% Confidence Interval|Number
2705011|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 3|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.|||Percentage of participants||95% Confidence Interval|Number
2705012|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 2|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.|||Percentage of participants||95% Confidence Interval|Number
2705013|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 1|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.|||Percentage of participants||95% Confidence Interval|Number
2705014|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion on day 4 after the crossover treatment|Day 4 after treatment||||degree||Standard Deviation|Mean
2705015|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle dorsiflexion passive range of motion|Day 1 after treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.|||degree||Standard Deviation|Mean
2705016|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion at day 4 before the crossover treatment|day 4 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.|||degree||Standard Deviation|Mean
2705017|NCT01207570|Primary|Ankle Passive Range of Motion|The ankle passive range of motion will be measured by a Myrin goniometer.|day 1 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.|||degree||Standard Deviation|Mean
2705018|NCT01207492|Secondary|Clinical Benefit Rate|To determine the clinical benefit rate [% CR + % PR + % stable disease by RECIST 1.1] at 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|6 months||||percentage of participants||95% Confidence Interval|Number
2705019|NCT01207492|Secondary|Overall Tumor Response Rate (OR)|To determine overall tumor response rate [% complete response (CR) + % partial response (PR) by RECIST 1.1]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|2 years||||percentage of participants||95% Confidence Interval|Number
2705020|NCT01207492|Primary|Percentage of Participants With Progression Free Survival|To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months||||percentage of participants with PFS||95% Confidence Interval|Number
2705021|NCT01207466|Primary|Quality of Vision (Crisp and Clear)|Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale|Participants|Standard Deviation|Mean
2705022|NCT01207453|Secondary|Knee Pain Threshold|A measure of the change in knee pain threshold from baseline to 6 weeks. Knee pain threshold was determined by applying pressure to a subject's knee until the subject felt pain. The difference between the average knee pain threshold (an average for the right and left knees) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
2705023|NCT01207453|Secondary|Wrist Pain Threshold|A measure of the change in wrist pain threshold from baseline to 6 weeks. Wrist pain threshold was determined by applying pressure to a subject's wrist until the subject felt pain. The difference between the average wrist pain threshold (an average for the right and left wrists) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
2705024|NCT01207453|Secondary|Trapezius Pain Threshold|A measure of the change in trapezius pain threshold from baseline to 6 weeks. Trapezius pain threshold was determined by applying pressure to a subject's trapezius muscle until the subject felt pain. The difference between the average trapezius pain threshold (an average for the right and left trapezii) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
2705603|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Species|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705025|NCT01207453|Secondary|Thumbnail Pain Threshold|A measure of the change in thumbnail pain threshold from baseline to 6 weeks. Thumbnail pain threshold was determined by applying pressure to a subjectt's thumbnail until the subject felt pain. The difference between the average thumbnail pain threshold (an average for the right and left thumbs) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
2705026|NCT01207453|Secondary|Symptom Intensity Scale (SIS)|A measure of the change in SIS score from baseline to 6 weeks. The SIS score ranges from 0-9.75, with high scores being worse indicating more widespread pain and fatigue.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2705027|NCT01207453|Secondary|Change in Conditioned Pain Modulation (CPM)|CPM is defined as the difference between pain threshold A (measured after a conditioning stimulus activates pathways that inhibit pain) and pain threshold B (measured before the conditioning stimulus is applied). The conditioning stimulus was immersion of the hand in a cold water bath. Pressure pain threshold was assessed at the trapezius muscle initially. Subjects were then instructed to immerse their hand in a water bath for 30 seconds. At 20 seconds, pressure pain threshold at the trapezius was assessed again. We defined the magnitude of subjects' CPM as the difference in pressure pain threshold between baseline and 20 seconds after cold water immersion. This difference was compared to that measured at 6 weeks. The scale for the difference in CPM ranged from 0-11 kg/cm^2, with 0 indicating no change in CPM between 6 weeks and baseline and 11 indicating the maximum possible change. A greater change in CPM between baseline and 6 weeks is indicative of improvements in CPM.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
2705028|NCT01207453|Primary|Brief Pain Inventory (BPI) Change|"A measure of change in scores on the BPI short form, a 24-hr average pain item, from baseline to 6 weeks, The BPI short form scores ranges from 0-10, with 10 being the worst pain."|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2705029|NCT01207440|Secondary|Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Serious AE (SAE)|An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.|From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months)|The safety population included all participants who received at least 1 dose of ponatinib.|||Participants|||Count of Participants
2705030|NCT01207440|Secondary|Overall Survival (OS)|OS is defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive.|From the first dose of study treatment until death (Up to 96 months post last dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib.|||days||95% Confidence Interval|Median
2705031|NCT01207440|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval from the first dose of study treatment until the criteria for progression or death are met, censored at the last response assessment. Progression from CP is reported as death, development of AP or BP, loss of CHR (in the absence of cytogenetic response), confirmed by development in complete blood counts (CBCs) at least 4 weeks apart, loss of MCyR, increasing WBC in participant without CHR defined by doubling of WBC to >20K on 2 occasions at least 4 weeks apart; Progression from AP is reported as death, development of confirmed BP, loss of previous major or minor hematologic response over a 2-week period, no decrease from baseline levels in percentage blasts in peripheral blood or BM on all assessments over a 4-week period; Progression from BP or Ph+ ALL is reported as death, increasing blasts in peripheral blood or BM over a 4 week period.|Every 12 weeks ± 2 weeks from last dose of study drug or the investigator/participant decision to discontinue treatment, whichever occurred later (Up to approximately 96 months after last dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib.|||days||95% Confidence Interval|Median
2705032|NCT01207440|Secondary|Duration of Response|Duration of Response is defined as the interval between the first assessment at which the criteria for response are met until the criteria for progression are met, censored at the last date at which the criteria for response are met. Duration of response was estimated by the Kaplan-Meier method as the probability of remaining in response.|Up to approximately 48 months after first dose|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Number analyzed is number of participants with data available for analysis at given time-point|||days||Full Range|Median
2705033|NCT01207440|Secondary|Time to Response|Time to response is defined as the interval from the first dose of study treatment until the criteria for response are first met, censored at the last assessment of response. Median time to response was estimated using the Kaplan-Meier method.|Up to approximately 48 months after first dose|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Median time to response was reported for responders only. Participants who did not achieve the specified response were censored at the last response assessment. Number analyzed: participants with data available at given time-point.|||days||Full Range|Median
2705034|NCT01207440|Secondary|Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MMR|MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).|Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.|||percentage of participants||95% Confidence Interval|Number
2705604|NCT01202253|Secondary|Infecting Organisms by Species||Baseline up to Day 14 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
2705035|NCT01207440|Secondary|Percentage of AP-CML or BP-CML/Ph+ ALL Participants With Confirmed MCyR|Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart.|Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.|||percentage of participants||95% Confidence Interval|Number
2705036|NCT01207440|Secondary|Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MCyR|MCyR is defined as percentage of participants with CCyR or PCyR. Cytogenetic response is the percentage of Ph+ metaphases in BM. Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.|Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.|||percentage of participants||95% Confidence Interval|Number
2705037|NCT01207440|Secondary|Percentage of CP-CML Participants With Major Molecular Response (MMR)|MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).|Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.|||percentage of participants||95% Confidence Interval|Number
2705038|NCT01207440|Secondary|Percentage of CP-CML Participants With Confirmed MCyR|Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart. For CP participants entering the trial in PCyR, confirmed MCyR is defined as 2 assessments of CCyR at least 28 days apart.|Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.|||percentage of participants||95% Confidence Interval|Number
2705039|NCT01207440|Secondary|Percentage of CP-CML Participants With CHR|Response criteria for CHR is reported as WBC≤institutional upper limit of normal, platelets<450,000/mm^3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).|Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.|||percentage of participants||95% Confidence Interval|Number
2705040|NCT01207440|Primary|Percentage of BP-CML/Ph+ ALL Participants With MaHR|MaHR is defined as percentage of participants with CHR or NEL. Response criteria for CHR is reported as WBC≤institutional upper limit of normal, ANC≥1000/mm^3, platelets ≥100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL is reported as WBC≤ institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3 ≤platelets<100,000/mm^3; (ii) 500/mm^3≤ANC<1000/mm^3.|Up to 6 months after initiation of study treatment|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts E and F only.|||percentage of participants||95% Confidence Interval|Number
2705041|NCT01207440|Primary|Percentage of AP-CML Participants With Major Hematologic Response (MaHR)|MaHR is defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). Response criteria for CHR is reported as white blood cells (WBC)≤institutional upper limit of normal, absolute neutrophil count (ANC)≥1000/mm^3, platelets≥100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL is reported as WBC≤institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3≤platelets<100,000/mm^3; (ii) 500/mm^3≤ANC<1000/mm^3.|Up to 6 months after initiation of study treatment|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C and D only.|||percentage of participants||95% Confidence Interval|Number
2705042|NCT01207440|Primary|Percentage of CP-CML Participants With Major Cytogenetic Response (MCyR)|MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.|Up to 12 months after initiation of study treatment|Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.|||percentage of participants||95% Confidence Interval|Number
2705043|NCT01207427|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.|||Number of SBMs/week||Standard Error|Mean
2705605|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan||Baseline|Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.||||||
2705044|NCT01207414|Secondary|Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12|I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement.|Baseline, Week 12||||Score on a scale||Standard Deviation|Mean
2705045|NCT01207414|Secondary|Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12|Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2705046|NCT01207414|Secondary|Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12|Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2705047|NCT01207414|Secondary|Number of Participants With Adverse Events, Serious Adverse Events or Death|"Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen.~Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.~Additional information about adverse events can be found in the Adverse Event section."|12 Weeks|Participants from the Safety Analysis Set- all randomized participants who received study drug (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.|||Participants|||Number
2705048|NCT01207414|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12|The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2705049|NCT01207414|Primary|Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12|The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.|Week 12|Participants from the Full Analysis Set (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2705050|NCT01207401|Primary|Median Visual Analogue Score Measuring Pain|"We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:~Speculum placement~Tenaculum placement~Paracervical block administration(if subject is in this arm)~IUD insertion~Five minutes post procedure"|1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure||||units on a scale||Full Range|Median
2705051|NCT01207388|Secondary|Resource Utilization: Duration of Hospitalization||From first dose of study drug through the end of follow-up; median (minimum, maximum) time on study was 33.8 (1, 62) months.|Full analysis set|||days||Full Range|Median
2705052|NCT01207388|Secondary|Resource Utilization: Number of Participants Reporting Use of Transfusion of Blood Products||From first dose of study drug through the end of follow-up; median (minimum, maximum) time on study was 33.8 (1, 62) months|Full analysis set|||Participants|||Count of Participants
2705071|NCT01206816|Secondary|Number of Patients With Best Overall Response.|"Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response, partial response, stable disease, progressive disease or not evaluable.~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment).|Treated Set (TS)|||participants|||Number
2705053|NCT01207388|Secondary|Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales|The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of the core study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of the core study are reported for each dimension.|Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).|FAS with available data at relevant time points. For maximum change, the change from baseline was calculated using subset of FAS with available data (baseline and post-baseline) at the end of each cycle. The number analyzed are the number of subjects with available data at the time point at which maximum change from baseline was observed.|||units on a scale||Standard Error|Mean
2705054|NCT01207388|Secondary|Change From Baseline in EORTC-QLQ-C30 Scales|"The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).~For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.~The maximum changes from baseline to cycles 1 through 4 and the change from baseline to the end of the core study are reported."|Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).|FAS with available data at relevant time points. For maximum change, the change from baseline was calculated using subset of FAS with available data (baseline and post-baseline) at the end of each cycle. The number analyzed are the number of subjects with available data at the time point at which maximum change from baseline was observed.|||units on a scale||Standard Error|Mean
2705055|NCT01207388|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows:~Grade 1 - Mild AE;~Grade 2 - Moderate AE;~Grade 3 - Severe AE;~Grade 4 - Life-threatening or disabling AE;~Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~An AE was considered serious if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition."|From the first dose of blinatumomab until 30 days after last dose; the median treatment duration was 55 days.|All participants who received any infusion of blinatumomab.|||participants|||Number
2705056|NCT01207388|Secondary|Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders|MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.|Baseline and end of cycle 1 (6 weeks)|Full analysis set participants who were in hematological complete remission at treatment start, with no MRD Response in the first treatment cycle, excluding Philadelphia-positive participants.|||Participants|||Count of Participants
2705057|NCT01207388|Secondary|Duration of Complete MRD Response|"The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively.~MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4. Hematological relapse is defined as the unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia."|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants, who had an MRD complete response at cycle 1|||months||95% Confidence Interval|Median
2705058|NCT01207388|Secondary|Time to Hematological Relapse|Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.|||months||95% Confidence Interval|Median
2705059|NCT01207388|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.|100 days after HSCT, as of the data cut-off date of 05 August 2015|Full analysis set participants who underwent HSCT prior to relapse (hematological or extramedullary) excluding Philadelphia-positive participants|||percentage of participants||95% Confidence Interval|Number
2705060|NCT01207388|Secondary|Overall Survival|Overall survival was measured from the first treatment with blinatumomab until death due to any cause. Participants who did not die were censored at their last contact date.|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set|||months||95% Confidence Interval|Median
2705606|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Microbiological Analysis|Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
2705061|NCT01207388|Secondary|Hematological Relapse-free Survival (RFS)|"Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively.~Hematological relapse was defined as unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first).~The 18-month Kaplan-Meier estimate of hematological RFS is reported."|18 months, up to the data cut-off date of 05 August 2015|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.|||percentage of participants||95% Confidence Interval|Number
2705062|NCT01207388|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle|"At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.~Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle."|During the first cycle (6 weeks)|Primary endpoint full analysis set (Prim EP FAS) included all participants with an Ig TCR PCR MRD assay with the minimum required sensitivity of 1 x 10^-4 at central lab established at Baseline.|||percentage of participants||95% Confidence Interval|Number
2705063|NCT01207219|Secondary|Severity of Symptoms|PANSS total score is computed by summing the scores of positive, negative and general symptom subscores. The range of PANSS total score is from 30 to 210, range of PANSS positive and negative subscores is from 7 to 49, range of PANSS general symptoms subscore is from 16 to 112, with higher values representing worse outcome. CDS total score is computed by summing the scores of nine items of the scale. The range of CDS total score is from 0 to 27, with higher values representing worse outcome.|Baseline and 12 weeks|One subject in the waitlist control group has not completed all measures both at the baseline and 12 weeks. Measure of clinical severity has been missing in the data set. So that there are 37 subjects' data of clinical severity has been included for analysis.|||units on a scale||Standard Deviation|Mean
2705064|NCT01207219|Primary|Attention and Concentration|"measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter C and E as quickly as possible. The time to completion, number of error and omission items were recorded. A quality of search index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome)."|baseline and 12 weeks||||Correct number per second||Standard Deviation|Mean
2705065|NCT01207219|Primary|Working Memory|measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.|baseline and 12 weeks||||Scores on a scale||Standard Deviation|Mean
2705066|NCT01207219|Primary|Verbal Retention|The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.|baseline and 12 weeks||||correctly recorded words||Standard Deviation|Mean
2705067|NCT01207219|Primary|Verbal Acquisition|Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.|baseline and 12 weeks||||correctly encoded words||Standard Deviation|Mean
2705068|NCT01207102|Secondary|"To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With Triple Negative Stage IV Metastatic Breast Cancer"|The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.|2 years|Due to insufficient accrual, data analysis was not performed.||||||
2705069|NCT01207102|Primary|PFS|The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.|PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first|Due to insufficient accrual, data analysis was not performed.||||||
2705070|NCT01206816|Secondary|Number of Patients With Disease Control|"Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control.~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment).|Treated Set (TS)|||participants|||Number
2705072|NCT01206816|Secondary|Number of Patients With Objective Response (OR)|"Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).~As Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions."|Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment).|Treated Set (TS)|||participants|||Number
2705623|NCT01202253|Secondary|Percentage of Participants With Oral Antifungal Started to Complete Therapy||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705074|NCT01206816|Primary|Maximum Tolerable Dose (MTD) of Two Combination Therapy of Volasertib and Afatinib.|"Maximum Tolerable Dose (MTD) was determined by dose escalation for volasertib and afatinib. The 3 + 3 design with de-escalation for both the Schedules A and B. Patients were sequentially allocated to the dose cohorts. Apart from allocation to the treatment schedules, escalation and/or de-escalation to determine the MTD occurred independently within the 2 dose schedules. Cohorts of 3 patients were to be treated at the starting dose levels according to the treatment schedule. Before entering patients at a higher dose level, all patients at the previous dose level combination had to complete at least the initial cycle of 21 days."|MTD was assessed during the first cycle of combination of Volasertib and Afatinib therapy (22 days)|Treated Set (TS)|||mg|||Number
2705075|NCT01206816|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|MTD was defined on the basis of DLTs occuring during Cycle 1 of the dose escalation part in each of the 2 treatment schedules. DLTs were defined as drug related based on Common Terminology Criteria for AE's (CTCAE) Grade(G) :1) G4 neutropenia (ANC, including bands, <500/mm³) for more than 7 days, 2) G3 or 4 neutropenia associated with fever >38.5° C (febrile neutropenia),3) Neutropenic infection G ≥3, 4) G4 thrombocytopenia or G3 thrombocytopenia associated with bleeding requiring whole blood transfusion.5) Non-haematological G ≥3 toxicity excluding: (a) untreated G3 diarrhoea, (b) untreated G3 nausea and/or vomiting, (c) untreated G3 rash. 6) G2 increase in AST and/or ALT in conjunction with an elevated bilirubin level of G ≥2, 7) G2 nausea and/or vomiting despite optimal supportive/antiemetic treatment for at least 7consecutive days. 8) G2 diarrhoea for 2 or more consecutive days despite antidiarrhoeal medication/hydration, 9) Decrease in left ventricular function G ≥2.|22 Days|Treated Set (TS)|||participants|||Number
2705076|NCT01206777|Secondary|Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice|Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice.|6 months, as a before and after infusion survey|Post infusion surveys were collected and de-identified by assignment of an individual nurse identification number|||percentage of nurses satisfied|||Number
2705077|NCT01206777|Secondary|Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule||Determined from difference in expected time by package insert administration and actual time on day of treatment||||minutes for rapid R infusion||95% Confidence Interval|Mean
2705078|NCT01206777|Primary|Incidence of Grade III and IV Hypersensitivity Reactions||Every 15 minutes from start of infusion until completion, for up to 1 hour||||percentage of patients|||Number
2705079|NCT01206764|Secondary|Overall Survival|Overall survival is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.|Approximately 4 years|The Intent-to-Treat population (ITT population) consisted of all patients treated with RAD001.|||Weeks||95% Confidence Interval|Median
2705080|NCT01206764|Secondary|Duration of Response (DOR)|The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause|Approximately 4 years|The Intent-to-Treat population (ITT population) consisted of all patients treated with RAD001.|||Weeks||95% Confidence Interval|Median
2705081|NCT01206764|Secondary|Objective Response Rate (ORR; Where ORR = CR + PR)|The overall tumor response was based on the data as per local radiological review, following RECIST criteria. The ORR is defined as the proportion of patients with CR or PR and was summarized in terms of percentage with 95% exact Clopper-Pearson CIs|Approximately 4 years|The Intent-to-Treat population (ITT population) consisted of all patients treated with RAD001.|||Percentage of participants||95% Confidence Interval|Number
2705082|NCT01206764|Secondary|Disease Control Rate (Stable Disease [SD] + Partial Response [PR] + Complete Response [CR]);|The disease control rate was based on the data as per local radiological review following the RECIST criteria. The disease control rate is defined as the proportion of patients with CR, PR, or SD and was summarized in terms of percentage with 95% exact Clopper-Pearson CIs|Approximately 4 years|The Intent-to-Treat population (ITT population) consisted of all patients treated with RAD001.|||Percentage of Participants||95% Confidence Interval|Number
2705083|NCT01206764|Primary|PFS (Progression-Free Survival)|the time from the date of the start of RAD001 treatment to the date of the first documented disease progression or death due to any cause|Approximately 4 years|The Intent-to-Treat population (ITT population) consisted of all patients treated with RAD001.|||Weeks||95% Confidence Interval|Median
2705084|NCT01206738|Primary|Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire|GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire|27/1/20111 - 15/5/2011|880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively.|||participants|||Number
2705085|NCT01206738|Primary|Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed|Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.|Immediately after completion of questionnaire||||scenarios||Standard Deviation|Mean
2705086|NCT01206660|Secondary|Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Day 28|ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||units on a scale||Standard Deviation|Mean
2705087|NCT01206660|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each the three signs and symptoms (erythema, scaling and plaque elevation).|Day 28||||participants|||Number
2705088|NCT01206660|Primary|Clinical Success ITT|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Analysis was conducted using Intent-to-Treat (ITT)|||participants|||Number
2705090|NCT01206608|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores|Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.|Through 96 hours postdose||||Units on a scale*hours||Standard Deviation|Mean
2705091|NCT01206595|Secondary|Number of Patients With Adverse Events|All adverse events were to be recorded from the time of dosing through Day 8. Serious adverse events (SAEs) were to be recorded through Day 30.|Through 30 days postdose|||||||
2705092|NCT01206595|Primary|Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.|Through 96 hours postdose||||hours||Inter-Quartile Range|Median
2705093|NCT01206582|Secondary|Leukocyte and Platelet Counts|Measured by complete blood count|baseline, Day 4, Day 7, Day 56||||number x 10^9 cells/L||Standard Error|Mean
2705094|NCT01206582|Secondary|Erythrocyte Count|Measured by complete blood count|baseline, Day 4, Day 7, Day 56||||number x 10^12 erythrocytes/L||Standard Error|Mean
2705095|NCT01206582|Secondary|Hemoglobin|Measured by complete blood count|baseline, Day 4, Day 7, Day 56||||g/dL||Standard Error|Mean
2705096|NCT01206582|Secondary|Activated Partial Thromboplastin Time (APTT)||baseline, Day 4, Day 7, Day 56||||Seconds||Standard Error|Mean
2705097|NCT01206582|Secondary|Prothrombin Time||baseline, Day 4, Day 7, Day 56||||International Normalized Ratio (INR)||Standard Error|Mean
2705098|NCT01206582|Secondary|Serum Creatinine||baseline, Day 4, Day 7, Day 56||||mg/dL||Standard Error|Mean
2705099|NCT01206582|Secondary|Autonomic Functions|Subjects completed a standardized autonomic symptom questionnaire, the Composite Autonomic Severity Score (CASS) which consists of 2 subscores: cardiovagal (CASS-vag; 0-3) and adrenergic (CASS-adr;0-3), where 0, 1, 2, 3 represent non, mild, moderate, and severe dysfunction, respectively.|baseline, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||units on a scale||Standard Error|Mean
2705100|NCT01206582|Secondary|Gastrointestinal Symptoms|Subjects recorded their GI symptoms every day in the validated Gastroparesis Cardinal Symptom Index (GCSI) - Daily Diary. For each subject, the daily GCSI data were averaged per week. Components coded 0 (no symptoms) to 5 (very severe). GCSI total score is the average of 9 components from the nausea/vomiting, fullness/early satiety, and bloating subscores. These individual subscores are averages of 3,4, and 2 components, respectively. Subscores for upper and lower abdominal pain, heartburn/regurgitation and FDA nausea, vomiting, fullness, and pain (NVFP) composite are averages of 2, 2, 7, and 4 components, respectively.|baseline, 8 weeks|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||units on a scale||Standard Error|Mean
2705101|NCT01206582|Primary|Gastric Emptying Half-time|The time for half of the ingested solids or liquids to leave the stomach. Gastric emptying was assessed with ^13C Spirulina Breath Test. After an overnight fast, subjects consumed the test meal containing ^13C Spirulina. Breath samples were collected in duplicate glass tube using a straw to blow into the bottom of the tube to displace contained air. The ^13CO_2 content of the breath was determined by AB Diagnostics. The provide of ^13CO_2 excretion is used to estimate the half-time of gastric emptying.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||minutes||Standard Error|Mean
2705102|NCT01206582|Primary|Venous Monocyte HO1 Activity|HO1 activity in white blood cells was measured by an assay that measures bilirubin production as a marker of HO1 activity.|baseline, Day 3, Day 7, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||pmol bilirubin/mg/h||Standard Error|Mean
2705103|NCT01206582|Primary|Venous Plasma Heme-oxygenase 1 (HO1) Protein Concentration|HO1 protein concentration levels in plasma were assessed with a HO1 (human) enzyme-linked immunosorbent assay (ELISA) kit.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||ng/mL||Standard Error|Mean
2705104|NCT01206517|Primary|Terminal Phase (Elimination) Half-life (t1/2) of Asenapine|Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||hr||Standard Deviation|Mean
2705105|NCT01206517|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine|AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||hr*ng/mL||Standard Deviation|Mean
2705106|NCT01206517|Primary|Time to Maximum Plasma Concentration (Tmax) of Asenapine|tmax is the time from dosing to maximum plasma drug concentration levels.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||hr||Full Range|Median
2705107|NCT01206517|Primary|Maximum Plasma Concentration (Cmax) of Asenapine|Cmax is the peak plasma concentration following a dose of the study drug.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2705108|NCT01206478|Secondary|Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores|Non-communicating Children's Pain Checklist - Revised (NCCPC-R) used to measure outcome. The NCCPC-R is a 30 item measure intended to assess pain in children who are unable to speak because of cognitive or physical impairments. There are 7 sub-scales including vocal, social, facial, activity, body/limbs, physiological, and eating/sleeping. Each question has a potential score of 0 to 3. Scores are totaled for each sub-scale. Sub-scale scores are then added together for the Total Score. Total Scores can range from 0 to 90. The higher the score, the higher level of pain indicated by the child. This measure was completed by parents at week 0, week 10, and week 24.|baseline, 24 weeks||||units on a scale||Standard Deviation|Mean
2705109|NCT01206478|Primary|% Calories Taken Orally|Percent Kilocalories (kcal) Obtained Orally. This measure was obtained using the 24 hour food recall, a standardized five-pass method developed by the US Department of Agriculture for use in national dietary surveillance. This measure has been widely used in several large trials and data suggest it is the most valid and reliable method of dietary assessment for children (20). The data were collected at week 0, week 10, and week 24 using standardized probes by highly trained research staff, and parents were presented with paper food models and measuring devices prior to interviews to reference during the recall. Recalls were analyzed with the Nutritional Data System for Research, version 2005; University of Minnesota, Minneapolis, MN.|baseline, 24 weeks||||change in percent kcal obtained orally||Standard Deviation|Mean
2705110|NCT01206465|Secondary|Time to Disease Progression in All Participants||restaging imaging done after each two 4-week course until time of progression (longest time to progression = 588 days)||||days||Full Range|Median
2705111|NCT01206465|Secondary|Pharmacokinetics of 5-FU - Cmax Plasma Levels|5-FU plasma levels|22, 23, 45 & 46 hours during the 48 hour infusion||||mg/m^2||Standard Deviation|Mean
2705112|NCT01206465|Secondary|Number of Participants With Polymorphisms in Methylenetetrahydrofolate Reductase and Thymidylate Synthase||Prior to the first dose of protocol therapy||||percentage of patients|||Number
2705113|NCT01206465|Secondary|Pharmacokinetics of PDX- AUClast||Pre-treatment, end of infusion, at 15, 30, and 60 min, and then at 2, 4, 6, 8, 12, 22, 23, 24, 45, and 46 hours for PDX.|AUClast|||ng/ml *hr||Standard Deviation|Mean
2705114|NCT01206465|Secondary|Number of Patients Experiencing Grade 3-4 Toxicity While Receiving the Combination of PDX and 5-FU|patients remained on study as long as they did not progress, and wished to continue on study (no limit on number of cycles)|"., From the time the subject signs the consent form and ending 4 weeks following the final chemotherapy, an average of 3 years"||||participants|||Number
2705115|NCT01206465|Secondary|Number of Participants With Response to Therapy in Subjects With Measurable Disease||restaging imaging done after each two 4-week course until time of progression (the maximum duration of PFS = 588 days)||||Participants|||Count of Participants
2705116|NCT01206465|Primary|Recommended Dose of PDX Given in Combination With a Fixed Dose of 5-FU Administered as a 48-hour Infusion Given Every Other Week|Maximum tolerated dose will have been exceeded when 2 patients entered at a given dose level experience specified dose-limiting toxicities in the initial cycle|During the initial course (day 1 & 15 of a 4 week schedule)||||mg per meter square|||Number
2705117|NCT01206452|Secondary|Inflammatory Cytokine Response to Ablation Procedure|Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.|24 Hours after Ablation Procedure||||pg/ml||Standard Deviation|Mean
2705118|NCT01206452|Secondary|Inflammatory Cytokine Response to Ablation Procedure|Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.|Immediately Post-Ablation Procedure||||pg/ml||Standard Deviation|Mean
2705119|NCT01206452|Secondary|Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months|Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 3 months up to 6 months post-procedure||||Participants with AF recurrence|||Number
2705120|NCT01206452|Secondary|Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months|Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 0 months up to 3 months post procedure||||Participants with AF recurrence|||Number
2705121|NCT01206452|Primary|Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months|Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 6 months up to 12 months post-procedure||||Participants with AF recurrence|||Number
2705122|NCT01206439|Secondary|Exercise Tolerance|Changes in exercise tolerance and time from baseline to 180 days.|Baseline to day 180.|||||||
2705123|NCT01206439|Primary|Change in Systolic and Diastolic Myocardial Function|Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.|Baseline to day 180|Insufficient data to analyze.||||||
2705169|NCT01205776|Secondary|Number of Participants With Requirement for Blood Product Transfusion|"All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows:~Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units];~Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3]."|4 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705124|NCT01206387|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28|"Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis~The Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~For the %Body Surface Area Affected the Rule of Nine was be used.~Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline]."|Baseline and day 28|Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28|||percentage of body surface area affected||Standard Deviation|Mean
2705125|NCT01206387|Secondary|Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)|"Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT)~TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation~The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance."|Baseline and day 28|Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28|||units on a scale||Standard Deviation|Mean
2705126|NCT01206387|Secondary|Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.|"In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges).~The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined."|Baseline and day 28|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed|||units on a scale||Standard Deviation|Mean
2705127|NCT01206387|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).|28 days||||participants|||Number
2705128|NCT01206387|Primary|Clinical Success|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Primary Efficacy Analysis at Day 28 Clinical Success (ITT)|||participants|||Number
2705129|NCT01206322|Primary|Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg)."|Acute changes within 2 hours||||ml/100g/min/mmHg||Standard Deviation|Mean
2705130|NCT01206322|Primary|Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).~Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order.~Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo."|Acute changes within 2 hours||||T-score||Standard Deviation|Mean
2705131|NCT01206140|Secondary|4 -Month Progression-free Survival Rate.|Progression-free survival rate was calculated using the survival distribution function, and 95% confidence limits were calculated using the log-log transformation. Progression was defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Four months||||percent of participants||95% Confidence Interval|Number
2705132|NCT01206140|Secondary|Number of Participants With Objective Response|Response evaluated using the Choi criteria. CR - disappearance of all lesions and no new lesions; PR - a decrease in size (the sum of longest diameters of target lesions as defined in RECIST) of 10% or more or a decrease in tumor density (HU) of 15% or more on CT and no new lesions and no obvious progression of nonmeasurable disease; SD - does not meet the criteria for CR, PR, or PD and no symptomatic deterioration attributed to tumor progression; PD - an increase in tumor size of 10% or more and does not meet criteria of PR by tumor density (HU) on CT or new lesions or new intratumoral nodules or increase in the size of the existing intratumoral nodules. Objective response = CR+PR.|Evaluated for response after every two cycles, up to 4.5 years.||||participants|||Number
2705133|NCT01206140|Primary|Progression-free Survival|Progression-free survival was estimated using the product-limit method of Kaplan and Meier. Progression wasl evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Until disease progression or death, up to 4.5 years||||months||95% Confidence Interval|Median
2705258|NCT01205581|Secondary|Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.|||percentage of participants|||Number
2705134|NCT01206101|Secondary|Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)|Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
2705135|NCT01206101|Secondary|Change in Islet Cell Yield During Culture|Change in islet cell yield from pre-culture to post-culture|From 0 hours pre-culture to 24 hours to 72 hours|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
2705136|NCT01206101|Secondary|Proportion of Insulin-Independent Subjects|Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation|At 52 weeks after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
2705137|NCT01206101|Secondary|Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events|Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events|From week 0 to week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
2705138|NCT01206101|Secondary|Number of Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself).|During week 0 to week 52|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
2705139|NCT01206101|Primary|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.|At week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
2705140|NCT01206062|Secondary|Small Vessel Cerebral Ischemic Disease|Additional data are being collected over the next year.|6 years||2018-11-30|11/2018||||
2705141|NCT01206062|Secondary|Decline in Cognitive Function|Additional data are being collected over the next year.|6 years||2018-11-30|11/2018||||
2705142|NCT01206062|Secondary|Dementia|Additional data are being collected over the next year.|6 years||2018-11-30|11/2018||||
2705143|NCT01206062|Secondary|Participants Who Developed End Stage Renal Disease||6 years||||Participants|||Count of Participants
2705144|NCT01206062|Secondary|Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR||6 years|Participants with CKD at baseline|||Participants|||Count of Participants
2705145|NCT01206062|Secondary|Number of Participants With All-cause Mortality||6 years||||Participants|||Count of Participants
2705146|NCT01206062|Primary|Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death||6 years||||Participants|||Count of Participants
2705147|NCT01205828|Secondary|Biomarker Analysis|To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.|6 months|Since the treatment showed no significant efficacy against HCC, therefore study of biomarker that predict responsiveness of the treatment was not carried out.||||||
2705148|NCT01205828|Secondary|Number of Participants Who Had Grade 3 or 4 Adverse Events|Record of all toxicities graded according to the NCI CTCAE version 3.0|6 months|grade 3 or 4 adverse events|||participants|||Number
2705149|NCT01205828|Secondary|Progression Free Survival|The number of months between a patient's enrollment and his/her disease progression|2 years||||months||95% Confidence Interval|Median
2705150|NCT01205828|Secondary|Overall Survival|the number of months between a patient's enrollment and his/her date of death|2 years||||months||95% Confidence Interval|Median
2705151|NCT01205828|Primary|Clinical Benefit Rate|complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria|8 weeks||||participants|||Number
2705152|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|5 years||||Participants|||Count of Participants
2705339|NCT01205165|Secondary|Number of Participants Achieving Alanine Aminotransferase (ALT) Normalization at Week 52|ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Only those set of participants with a baseline ALT value above the upper limit of the normal range was included in this analysis. The normal range for ALT is 7 to 43 Units/Liter.|At week 52|ITT population|||Participants|||Count of Participants
2705153|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|4 years||||Participants|||Count of Participants
2705154|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|3 years||||Participants|||Count of Participants
2705155|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|2 years||||Participants|||Count of Participants
2705156|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|1 year||||Participants|||Count of Participants
2705157|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|In-hospital (≤ 7 days of post index procedure)||||Participants|||Count of Participants
2705158|NCT01205776|Secondary|Number of Participants With Complete Revascularization (Residual = 0)|"Complete anatomic revascularization requires revascularization of all vessels ≥2.0 mm reference vessel diameter with a DS ≥60% (both as measured by core angiographic laboratory analysis).~-While this will be the pre-specified criteria for anatomically significant lesions, sensitivity analysis will be performed using different criteria (e.g. ≥2.5 mm vessels, DS ≥70%, etc.)~From the baseline angiogram, the angiographic core lab will identify and designate those lesions and vessels requiring revascularization in all subjects according to this definition, prior to knowledge of the extent of actual revascularization.~Following PCI, the angiographic core lab will determine the extent of revascularization (vessels with TIMI 2or3 flow post procedure with a core laboratory DS <50% considered successfully revascularized).~Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization."|At Baseline|Not all PCI patients have Baseline and Post-PCI Syntax score assessment.|||Participants|||Count of Participants
2705159|NCT01205776|Secondary|Number of Participants With Major Adverse Events (MAE)|"death~myocardial infarction~stroke~Transfusion of ≥2 units of blood~TIMI major or minor bleeding~major arrhythmia~unplanned coronary revascularization for ischemia~any unplanned surgery or therapeutic radiologic procedure~renal failure~sternal wound dehiscence~infection requiring antibiotics for treatment~intubation for > 48 hours~post-pericardiotomy syndrome"|30 days|ITT Population.|||Participants|||Count of Participants
2705160|NCT01205776|Secondary|Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding|"Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation.~Type 3 Type 3a~Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL~Any transfusion with overt bleeding Type 3b~Overt bleeding plus hemoglobin drop ≥5 g/dL*~Cardiac tamponade~Bleeding requiring surgical intervention for control~Bleeding requiring intravenous vasoactive agents Type 3c~Intracranial hemorrhage~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding"|5 years|ITT Population.|||Participants|||Count of Participants
2705259|NCT01205581|Primary|Number of Participants Achieving Seroprotection After Second Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|21 to 42 days after second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||number of participants|||Number
2705161|NCT01205776|Secondary|Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding|"Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation.~Type 3 Type 3a~Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL~Any transfusion with overt bleeding Type 3b~Overt bleeding plus hemoglobin drop ≥5 g/dL*~Cardiac tamponade~Bleeding requiring surgical intervention for control~Bleeding requiring intravenous vasoactive agents Type 3c~Intracranial hemorrhage~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding"|4 years|ITT Population.|||Participants|||Count of Participants
2705162|NCT01205776|Secondary|Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding|"Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation.~Type 3 Type 3a~Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL~Any transfusion with overt bleeding Type 3b~Overt bleeding plus hemoglobin drop ≥5 g/dL*~Cardiac tamponade~Bleeding requiring surgical intervention for control~Bleeding requiring intravenous vasoactive agents Type 3c~Intracranial hemorrhage~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding"|3 years|ITT Population.|||Participants|||Count of Participants
2705163|NCT01205776|Secondary|Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding|"Type 0: No bleeding Type 1: Bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: Any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation.~Type 3 Type 3a~Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL~Any transfusion with overt bleeding Type 3b~Overt bleeding plus hemoglobin drop ≥5 g/dL*~Cardiac tamponade~Bleeding requiring surgical intervention for control~Bleeding requiring intravenous vasoactive agents Type 3c~Intracranial hemorrhage~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: Fatal bleeding"|30 days|ITT Population.|||Participants|||Count of Participants
2705164|NCT01205776|Secondary|Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding|"Bleeding will be classified by the TIMI hemorrhage classification~Severity:~Major:~Intracranial hemorrhage~A ≥5 g/dL decrease in the hemoglobin concentration~A ≥15% absolute decrease in the hematocrit~Minor:~Observed blood loss:~A ≥ 3 g/dL decrease in the hemoglobin concentration~A ≥ 10% absolute decrease in the hematocrit~No observed blood loss:~A ≥ 4 g/dL decrease in the hemoglobin concentration~A ≥ 12% absolute decrease in the hematocrit~Minimal:~• Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit."|5 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705165|NCT01205776|Secondary|Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding|"Bleeding will be classified by the TIMI hemorrhage classification~Severity:~Major:~Intracranial hemorrhage~A ≥5 g/dL decrease in the hemoglobin concentration~A ≥15% absolute decrease in the hematocrit~Minor:~Observed blood loss:~A ≥ 3 g/dL decrease in the hemoglobin concentration~A ≥ 10% absolute decrease in the hematocrit~No observed blood loss:~A ≥ 4 g/dL decrease in the hemoglobin concentration~A ≥ 12% absolute decrease in the hematocrit~Minimal:~• Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit."|4 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705166|NCT01205776|Secondary|Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding|"Bleeding will be classified by the TIMI hemorrhage classification~Severity:~Major:~Intracranial hemorrhage~A ≥5 g/dL decrease in the hemoglobin concentration~A ≥15% absolute decrease in the hematocrit~Minor:~Observed blood loss:~A ≥ 3 g/dL decrease in the hemoglobin concentration~A ≥ 10% absolute decrease in the hematocrit~No observed blood loss:~A ≥ 4 g/dL decrease in the hemoglobin concentration~A ≥ 12% absolute decrease in the hematocrit~Minimal:~• Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit."|3 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705167|NCT01205776|Secondary|Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding|"Bleeding will be classified by the TIMI hemorrhage classification~Severity:~Major:~Intracranial hemorrhage~A ≥5 g/dL decrease in the hemoglobin concentration~A ≥15% absolute decrease in the hematocrit~Minor:~Observed blood loss:~A ≥ 3 g/dL decrease in the hemoglobin concentration~A ≥ 10% absolute decrease in the hematocrit~No observed blood loss:~A ≥ 4 g/dL decrease in the hemoglobin concentration~A ≥ 12% absolute decrease in the hematocrit~Minimal:~• Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit."|30 days|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705168|NCT01205776|Secondary|Number of Participants With Requirement for Blood Product Transfusion|"All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows:~Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units];~Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3]."|5 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705170|NCT01205776|Secondary|Number of Participants With Requirement for Blood Product Transfusion|"All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows:~Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units];~Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3]."|3 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705171|NCT01205776|Secondary|Number of Participants With Requirement for Blood Product Transfusion|"All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows:~Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units];~Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3]."|30 days|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705172|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 5 years|ITT population.|||Participants|||Count of Participants
2705173|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 4 years|ITT population.|||Participants|||Count of Participants
2705174|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705175|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705176|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705177|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705178|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 30 days|ITT population.|||Participants|||Count of Participants
2705179|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705180|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Very late (>1 year)|ITT population.|||Participants|||Count of Participants
2705181|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Late (>30 days - 1 year)|ITT population.|||Participants|||Count of Participants
2705182|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Subacute (1-30 days)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705183|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Acute (<= 24 hours)|ITT population.|||Participants|||Count of Participants
2705184|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Early (0-30 days)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705185|NCT01205776|Secondary|Percentage of Participants With Major Adverse Events (MAE)|Composite of death, myocardial infarction, stroke, transfusion of ≥ 2 units of blood, major arrhythmia, unplanned coronary revascularization for ischemia, any unplanned surgery or radiologic procedure, renal failure, sternal wound dehiscence, infection requiring antibiotics for treatment, intubation for > 48 hours, or post-pericardiotomy syndrome.|In-hospital|ITT Population.|||Percentage of participants|||Number
2705186|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2705187|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2705188|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705189|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2709327|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705190|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705191|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705192|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 30 days|ITT population.|||Participants|||Count of Participants
2705193|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705194|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 5 years|ITT population.|||Participants|||Count of Participants
2705195|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 4 years|ITT population|||Participants|||Count of Participants
2705196|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705197|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705198|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705199|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705200|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 30 days|ITT population.|||Participants|||Count of Participants
2705201|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705202|NCT01205776|Secondary|Number of Participants With Disability Following Stroke Event|"In case of an event of stroke disability at 90-days±2 weeks will be an overall measurement of severity of stroke as assessed by modified Rankin Scale (mRS) scale.~Stroke disability will be classified using an adaptation of the modified Rankin Scale as follows, the assessment of which will be based on the Modified Rankin Disability Questionnaire.~Scale 0; No stroke symptoms at all. (May have other complaints) Scale 1; No significant disability; symptoms present but no physical or other limitations.~Scale 2; Slight disability; limitations in participation in usual social roles, but independent for activities of daily living (ADL) Scale 3; Some need for assistance but able to walk without assistance Scale 4; Moderately severe disability; need for assistance with some basic ADL, but not requiring constant care Scale 5; Severe disability; requiring constant nursing care and attention."|90 days ± 2 weeks|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
2705203|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2705272|NCT01205503|Secondary|Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
2705204|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2705205|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705206|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705207|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705208|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705209|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 30 days|ITT population.|||Participants|||Count of Participants
2705238|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705210|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705211|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 5 years|ITT population|||Participants|||Count of Participants
2705212|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2705213|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705214|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705215|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705216|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705217|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 30 days|ITT population.|||Participants|||Count of Participants
2705218|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|In-hospital (≤ 7 days of post index procedure)|ITT population.|||Participants|||Count of Participants
2705219|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2705220|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2705221|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705222|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705223|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705224|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705225|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 30 days|ITT population.|||Participants|||Count of Participants
2705226|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705227|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"Death:~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2705228|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"Death:~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2705229|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"Death:~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2705230|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2705231|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705232|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705233|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 30 days|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705234|NCT01205776|Secondary|Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705235|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 5 years|ITT population|||Participants|||Count of Participants
2705236|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 4 years|ITT population|||Participants|||Count of Participants
2705237|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2709328|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705239|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2705240|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 6 months|ITT population.|||Participants|||Count of Participants
2705241|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|30 days||||Participants|||Count of Participants
2705242|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|In-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2705243|NCT01205776|Primary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|5 years||||Participants|||Count of Participants
2705244|NCT01205685|Secondary|Correlative Studies|Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin|< or = to 2 weeks before initiation of Phase II study treatment period|No correlative studies were performed because the study did not move to the Phase II portion||||||
2705245|NCT01205685|Secondary|Number of Participants With Tumor Response Per RECIST|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|Every 12 weeks to tumor progression|Patients who were available for measurement of tumor response.|||participants|||Number
2705246|NCT01205685|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.|Every 4 weeks up to 24 weeks|Patients who received treatment and experienced an adverse event.|||participants|||Number
2705247|NCT01205685|Primary|Anti-tumor Activity of OSI-906|Time to progression measured in months from study entry to date of disease progression|From study entry to 6 months|Patients who received treatment and who were available for determination of disease progression. One patient withdrew after beginning of treatment and was not available for determination of the duration of disease progression.|||months||Full Range|Median
2705248|NCT01205646|Secondary|Changes in Bone Turnover Markers|Changes in bone turnover markers using per cent change of BSAP and NTx|Four weeks after initiating zoledronte therapy|Patients who had both pre-treatment and post-treatment measures of BSAP and NTx.|||percentage of change in bio-marker||Full Range|Median
2705249|NCT01205646|Secondary|Change in Bone Scans|Change in bone scans using per cent change in SUVmax.|Four weeks after initiating zoledronate therapy|Sample population|||percentage of change of SUVmax||Full Range|Median
2705250|NCT01205646|Secondary|The Change in PSA After Zoledronate Therapy|The change in PSA after zoledronate therapy using per cent change.|Four weeks after initiating Zoledronate therapy|All patients who had their PSA measured both before and after therapy.|||percentage of change in PSA||Full Range|Median
2705251|NCT01205646|Primary|PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.|"PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a PET response. Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean."|Within 3 weeks||||Proportion of participants with response||90% Confidence Interval|Number
2705252|NCT01205581|Secondary|Comparison of Geometric Mean Ratios (GMR) by HAI|"GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later.~GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later."|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||Ratio|||Number
2705260|NCT01205581|Primary|Rate of Seroprotection After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||Percentage of participants|||Number
2705261|NCT01205581|Secondary|Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.|||percentagae of participants|||Number
2705262|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.~The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine||||percentrage of participants|||Number
2705263|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.~The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||percentage of participants|||Number
2705264|NCT01205581|Secondary|Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD|Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.|From initial vaccine administration through up to 8 months|Adverse events of Fluzone HD and Fluzone are provided as combined data from cancer and HIV patients, since there is no reason to believe one group is more susceptible to adverse events than the other.|||participants|||Number
2705265|NCT01205581|Primary|Rate of Seroconversion After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||percentage of participants|||Number
2705266|NCT01205568|Secondary|Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention|Late percent change in minimum lumen diameter from pre-intervention to follow-up angiography.|3 months post-intervention|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.|||percent change|vessels|Standard Deviation|Mean
2705267|NCT01205568|Primary|Acute Change in Minimum Lumen Diameter Immediately Post-intervention|The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.|Pre-intervention to immediate post-intervention (approximately 10 minutes)|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation. Patients had variable number of eligible vessels. Each eligible vessel was randomized at the time of procedure.|||percentage change|vessels|Standard Deviation|Mean
2705268|NCT01205529|Primary|ST Segment Elevation ≥ 1.5 mm in the Right Precordial Leads (V1-V3), Either at Baseline or Manifested After Sodium Channel Block With Intravenous Procainamide|Number of participants who demonstrated ST-segment elevation >1.5mm in the right precordial leads (V1-V3) either at baseline or after sodium channel block with intravenous procainamide infusion.|During (5, 10, 15, 20, 25, 30 minutes after initiating) or up to 15 minutes after completion of intravenous procainamide infusion|Number of subject who had >/= 1.5mm right precordial ST-segment elevation at baseline or with procainamide administration|||Participants|||Count of Participants
2705269|NCT01205503|Secondary|B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||pg/ml||95% Confidence Interval|Geometric Mean
2705270|NCT01205503|Secondary|Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||ng/ml||95% Confidence Interval|Geometric Mean
2705271|NCT01205503|Secondary|Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
2705273|NCT01205503|Primary|TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||log(pg/ml)||95% Confidence Interval|Geometric Mean
2705275|NCT01205451|Secondary|Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit|Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2705276|NCT01205451|Secondary|Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits|Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator's clinical judgment; no specific criteria were used.|Screening visit (-Week 1) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed.|||participants|||Number
2705277|NCT01205451|Secondary|Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit|Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2705278|NCT01205451|Secondary|Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Micromoles per Liter (μmol/L)||Standard Deviation|Mean
2705279|NCT01205451|Secondary|Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit|Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||International Units per Liter (IU/L)||Standard Deviation|Mean
2705280|NCT01205451|Secondary|Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||grams/L||Standard Deviation|Mean
2705281|NCT01205451|Secondary|Mean Change From Baseline in Hematocrit Value at the Exit Visit|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||percentage||Standard Deviation|Mean
2705282|NCT01205451|Secondary|Mean Change From Baseline in Hemoglobin Content at the Exit Visit|Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Grams per Liter (grams/L)||Standard Deviation|Mean
2705283|NCT01205451|Secondary|Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit|Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Percentage of the total WBC||Standard Deviation|Mean
2705284|NCT01205451|Secondary|Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit|Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||10^9 cells per Liter||Standard Deviation|Mean
2705285|NCT01205451|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit|Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and exit visit (Week 12 or earlier)|Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||10^12 cells per Liter||Standard Deviation|Mean
2705648|NCT01202188|Secondary|Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization||26 Weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2705286|NCT01205451|Secondary|GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12|The care giver or participant used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2705287|NCT01205451|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2705288|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2705289|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2705290|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2705291|NCT01205451|Secondary|Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12|Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||participants|||Number
2705292|NCT01205451|Primary|Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.|||scores on a scale||Standard Deviation|Mean
2705293|NCT01205438|Secondary|Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug. Non-responder imputation (NRI) included.|||percentage of participants|||Number
2705294|NCT01205438|Secondary|Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline|The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.|Baseline through 52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2705295|NCT01205438|Secondary|Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score|Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2705296|NCT01205438|Secondary|Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks|An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.|52 weeks|Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 2.5 mg/day at baseline are included.|||percentage of participants|||Number
2705297|NCT01205438|Secondary|Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares|"The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.~Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit."|Baseline through 52 weeks|Zero participants analyzed. Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE flare data was not collected for analysis.||||||
2705298|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores|A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2705299|NCT01205438|Secondary|Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks|Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.|52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.|||percentage of participants|||Number
2705300|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores|The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.|Baseline, 52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.|||units on a scale||Standard Deviation|Mean
2705301|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)|PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening defined as increase of ≤ 0.30 points from Baseline.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2705302|NCT01205438|Secondary|Time to First Severe SLE Flare (SFI)|"The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.~Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1)."|Baseline through 52 weeks|Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis.||||||
2705303|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score|SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2705304|NCT01205438|Secondary|Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||International Units (IU)||Standard Deviation|Mean
2705305|NCT01205438|Secondary|Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52|A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit.|52 weeks|Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.|||percentage of participants|||Number
2705340|NCT01205165|Primary|Mean Log 10 Reduction in Serum Hepatitis B Virus (HBV), Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, where the lower limit of detection was 300 copies/milliliter (mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to week 12 was calculated as the week 12 value minus the baseline value. Baseline was the Day 1 for the study, when participant received study drug. Log 10 reduction implied reduced viral load.|Baseline (Day 1) and Week 12|Intent to treat (ITT). All participants regardless of whether or not the participant completed the planned duration of the study were analyzed with no data exclusions.|||Log10 (copies/mL)||Standard Deviation|Mean
2705306|NCT01205438|Primary|Percentage of Participants Achieving an SLE Responder Index Response at Week 52|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.|||percentage of participants|||Number
2705307|NCT01205399|Secondary|Procedural Time for AlloMax Surgical Graft Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|0 Days|All enrolled subjects that could be verified through historical medical record review.|||minutes||Standard Deviation|Mean
2705308|NCT01205399|Secondary|Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit.|9+ Months|All enrolled subjects that could be verified through historical medical record review.|||complication events|||Number
2705309|NCT01205399|Primary|Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft|A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|9 + Months|All enrolled subjects that could be verified through historical medical record review.|||participants|||Number
2705310|NCT01205269|Secondary|Plasma AZD8683 AUC0-24|Area under the AZD8683 plasma concentration curve from 0 to 24 hours|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.|||nmol*h/L||Full Range|Geometric Mean
2705311|NCT01205269|Secondary|Plasma AZD8683 Cmax|Maximum plasma concentration of AZD8683|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.|||nmol/L||Full Range|Geometric Mean
2705312|NCT01205269|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||ms||Standard Deviation|Mean
2705313|NCT01205269|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||bpm||Standard Deviation|Mean
2705314|NCT01205269|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||bpm||Standard Deviation|Mean
2705315|NCT01205269|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||mmHg||Standard Deviation|Mean
2705316|NCT01205269|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||mmHg||Standard Deviation|Mean
2705317|NCT01205269|Secondary|Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose|Maximum FVC value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
2705318|NCT01205269|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose|Average FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
2705319|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
2705320|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
2705341|NCT01205152|Secondary|Effect of SC Asfotase Alfa on Respiratory Function|Outcome measure is the shift in the proportion of patients requiring respiratory support at their last assessment in Study ENB-003-08 compared with Baseline. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Participants|||Count of Participants
2709329|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705321|NCT01205230|Secondary|Number of Participants With the Indicated Event of Dose Limiting Toxicity (DLT)|The following were considered DLTs only while participants were receiving pazopanib co-administered with either ketoconazole or esomeprazole: Grade 4 hematologic toxicities, excluding lymphopenia; and Grade 3/4 non-hematologic toxicities, excluding alopecia and nausea/vomiting/diarrhea for which adequate supportive therapy had not been instituted. Toxicities observed once co-administration of pazopanib with ketoconazole or esomeprazole was complete (after Day 5 of Period 2) could also be considered DLTs if judged to be relevant by the investigator and the GlaxoSmithKline Medical Monitor.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population. Per protocol, a DLT could not occur during single-agent pazopanib administration in Period 1; thus, data were only collected and analyzed for those participants receiving pazopanib co-administered with either ketoconazole or esomeprazole in Period 2.|||participants|||Number
2705322|NCT01205230|Secondary|Number of Participants With the Indicated Grade 3 or 4 Adverse Events (AEs)|AEs were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). A Grade 3 AE is severe; defined as considerable interference with the participant's daily activities, medical intervention/therapy required, and hospitalization possible. A Grade 4 AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, and hospitalization probable.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population: all participants who were enrolled into the study and received at least one dose of study drug|||participants|||Number
2705323|NCT01205230|Secondary|Plasma Ketoconazole Concentration at the Indicated Time Points|Blood samples for the determination of plasma ketoconazole concentrations were collected before (pre-dose [within 60 minutes prior to pazopanib administration]) and after the final pazopanib and ketoconazole dose (fifth dose) during Period 2 at the indicated time points, relative to pazopanib administration (at 1 and 2 hours after pazopanib administration). Blood samples were obtained via peripheral intravenous cannula or central line. Concentrations of ketoconazole were determined in plasma samples using the currently approved analytical methodology.|Day 5 of Period 2 (combination therapy). Blood samples were collected within 60 minutes prior to pazopanib administration and 1 and 2 hours after pazopanib administration.|PK Population|||mcg/mL||Full Range|Mean
2705324|NCT01205230|Secondary|Tmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||hr||Full Range|Median
2705325|NCT01205230|Secondary|Plasma Cmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||mcg/mL||95% Confidence Interval|Geometric Mean
2705326|NCT01205230|Secondary|Plasma AUC(0-24) for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population. One participant from the Pazopanib + Ketoconazole treatment arm was not analyzed for GSK1071306 due to mishandling of PK samples during shipping. Only those participants providing samples were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
2705327|NCT01205230|Secondary|Plasma Concentration at 24 Hours After Administration (C24) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Pazopanib plasma concentration-time data were analyzed by non-compartmental methods with WinNonlin. Calculations were based on the actual sampling times. From the plasma concentration-time data, the PK parameter C24 was determined.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained 24 hours after administration of pazopanib.|PK Population|||mcg/mL||95% Confidence Interval|Geometric Mean
2705328|NCT01205230|Primary|Time of Occurrence of Cmax (Tmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||hours (hr)||Full Range|Median
2705329|NCT01205230|Primary|Plasma Maximum Observed Concentration (Cmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||mcg/mL||95% Confidence Interval|Geometric Mean
2705330|NCT01205230|Primary|Plasma Pazopanib Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC[0-24]) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for pharmacokinetic (PK) analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|Pharmacokinetic (PK) Population: all participants who underwent plasma PK sampling and had evaluable PK assay results from at least one analyte|||Hour*micrograms/milliliters (hr*mcg/mL)||95% Confidence Interval|Geometric Mean
2705331|NCT01205165|Secondary|Mean Log 10 Reduction in Serum HBV DNA Level From Baseline to Week 52|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to Week 52 was calculated as the Week 52 value minus the baseline value. Baseline was the Day 1 for the study when participant received study drug. Log 10 reduction implied reduced viral load|Baseline (Day 1) and Week 52|ITT population|||Log10 (copies/mL)||Standard Deviation|Mean
2705332|NCT01205165|Secondary|Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52|The data for clinical chemical parameters namely sodium, potassium, calcium, phosphorus, total protein, albumin, amylase, creatinine phospho kinase, creatinine, blood urea nitrogen, total bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase, and prothrombin time as per the scheduled assessments and also according to maximum CTC toxicity grade was reported. The data for number of participants with shift in grade for clinical chemistry parameters at Week 12 and Week 52 were reported.|Baseline (Day 1), Week 12 and Week 52|ITT population. Only those participants available at the specified time points were analyzed|||Participants|||Count of Participants
2705333|NCT01205165|Secondary|Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52|The data for hematology parameters was summarized for Hemoglobin, Red blood cells (RBC), Platelets, Neutrophils, Lymphocytes, Monocytes, and Eosinophil as per the scheduled assessments and also according to maximum grade common terminology criteria (CTC) toxicity grade. The data for number of participants with shift in grade for hematology parameters at Week 12 and Week 52 were reported.|Baseline (Day 1), Week 12 and Week 52|ITT population.|||Participants|||Count of Participants
2705334|NCT01205165|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)|AE is defined as, any untoward medical occurrence in a participant or clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose, results in death; is life threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity, is a congenital anomaly/birth defect or requires medical intervention.|From treatment initiation (Week 0) to follow-up (up to 52 weeks)|ITT population.|||Participants|||Count of Participants
2705335|NCT01205165|Secondary|Number of Participants Achieving ALT Normalization at Week 12|ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. The normal range for ALT is 7-43 Units/Liter. Only those set of participants with a baseline ALT value above the upper limit of the normal range were included in this analysis, done at week 12.|at Week 12|ITT population|||Participants|||Count of Participants
2705336|NCT01205165|Secondary|Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52|The HBeAg loss, defined as the number of participants with an undetectable level of serum HBeAg. The percentage of participants with a HBeAg seroconversion, defined as an undetectable level of serum HBeAg and a detectable level of serum hepatitis B e antibody (HBeAb) at Week 52. The number of participants with HBsAg loss was defined as an undetectable level of serum HBsAg; and those participants with HBsAg seroconversion were defined as an undetectable level of serum HBsAg and a detectable level of serum HBsAb. All these participant were reported at week 52. Only the subset of participants, with above parameters detectable at baseline were included and for participants with post-baseline values missing were considered as non-responders.|Week 52|ITT population. Only the subset of participants with HBeAg and HBsAg positive at baseline (Day 1) was included in the analysis.|||Participants|||Count of Participants
2705337|NCT01205165|Secondary|HBV DNA Levels at Each Collection Timepoint Through Week 52|Serum HBV DNA at different timepoints namely Baseline, Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 were reported. The HBV DNA copies in the serum were reported in multiples of log 10 copies per mL, detected using Roche COBAS AMPLICOR HBV monitor.|Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52|ITT population. Only those participants available at the specified timepoints were analyzed|||log 10 copies/mL||Standard Deviation|Mean
2705338|NCT01205165|Secondary|Number of Participants Achieving Virological Response at Week 52|Virological response was defined as HBV DNA level < 300 copies/ml in serum. The number of participants achieving these DNA levels were reported.|At Week 52|ITT population.|||Participants|||Count of Participants
2705649|NCT01202188|Secondary|Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period||26 Weeks|Full Analysis Set includes all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2705342|NCT01205152|Secondary|Effect of SC Asfotase Alfa on Growth: Height/Length Z-scores|Outcome measure is the change from Baseline in Z-scores for height/length. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Z-score||Full Range|Median
2705343|NCT01205152|Secondary|Effect of SC Asfotase Alfa on Growth: Weight Z-scores|Outcome measure is the change from Baseline in Z-scores for weight. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Z-score||Full Range|Median
2705344|NCT01205152|Secondary|Long-term Pharmacodynamics (PD) of SC Asfotase Alfa: Pyridoxal-5-phosphate (PLP) Levels|Outcome measure is the change from Baseline in pyridoxal-5-phosphate (PLP) levels. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08). Change from Baseline could not be calculated for 2 patients because of non-evaluable samples at Baseline.|||ng/mL||Full Range|Median
2705345|NCT01205152|Secondary|Long-term Pharmacodynamics (PD) of SC Asfotase Alfa: Plasma Inorganic Pyrophosphate (PPi) Levels|Outcome measure is the change from Baseline in plasma inorganic pyrophosphate (PPi) levels. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08). Change from Baseline could not be calculated for 3 patients due to non-evaluable samples at Baseline.|||uM||Full Range|Median
2705346|NCT01205152|Primary|Long-term Efficacy of Asfotase Alfa in Treating Rickets in Infants and Young Children With Hypophosphatasia (HPP).|"Outcome measure is the evaluation of radiographic change in rickets severity using a qualitative Radiographic Global Impression of Change (RGI-C) Scale. Skeletal radiographs obtained at the patient's last assessment were compared with skeletal radiographs obtained before initiation of treatment (Baseline in Study ENB-002-08 [NCT00744042]). The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete healing of HPP-associated rickets).~The time period is pre-dose (Baseline from ENB-002-08 study) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies."|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||scores on a scale||Full Range|Median
2705347|NCT01205152|Primary|Long-term Tolerability of Subcutaneous (SC) Asfotase Alfa|Outcome measure is the number of patients with 1 or more treatment-emergent adverse event. The time period is from Baseline in the ENB-003-08 study to the end of the ENB-003-08 study.|84 months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Participants|||Count of Participants
2705348|NCT01205126|Secondary|Breakthrough Pain Medication (Rescue Medication) Doses Taken|Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain.|Baseline up to Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure.|||Doses||Standard Deviation|Mean
2705349|NCT01205126|Secondary|Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
2705350|NCT01205126|Secondary|Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
2705351|NCT01205126|Secondary|Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
2705352|NCT01205126|Secondary|Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
2705353|NCT01205126|Primary|Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication.|||Units on a scale||Standard Deviation|Mean
2705354|NCT01205035|Secondary|Angiographic Leakage From Baseline to Month 6 and 12|"Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 6. Also any decreases of angiographic leakage was counted between baseline and 6 month. The same was done between baseline and 12 month.~Any increase of angiographic leakage was counted as a +1. Likewise, any decrease of angiographic leakage was counted as a -1. The sum was calculated based on the number of participants in each arm and the total shown in the outcome. For example: if across the three injected participants for their 6 month visit, two of them showed an increase of angiographic leakage and one showed a decrease, then the outcome would be, (+1) + (+1) + (-1)= +1. Likewise, if the same three participant's 12 month visit showed two with a decrease in leakage and one with no changes in leakage, the outcome would be, (-1) + (-1) + (0)= -2"|Baseline to 6 and baseline to 12 months||||Sum of increases (+1) and decreases (-1)|||Number
2705355|NCT01205035|Secondary|Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg||Baseline to 6 month, baseline to 9 month and baseline to 12 months||||Number of Adverse Events|||Number
2705356|NCT01205035|Secondary|Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months|A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.|Baseline to 6, 9, and 12 months||||Micrometer||Full Range|Mean
2705357|NCT01205035|Secondary|Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months||Baseline to 6 months and baseline to 9 months||||LogMAR Unit||Full Range|Mean
2705358|NCT01205035|Primary|Visual Acuity Change From Baseline to Month 12 of the Study||Baseline to 12 months||||LogMAR Unit||Full Range|Mean
2705359|NCT01204918|Secondary|Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)|A commonly used instrument originally developed by NIMH and adapted into a self-report instrument. The version of the scale that we plan to use examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. Presented below are counts of people that had experienced the event by 8 weeks.|8 weeks|All subjects are included in the analysis- with the exception of sex specific conditions.|||participants|||Number
2705360|NCT01204918|Secondary|Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline|Responders having at least a 50% improvement in MADRS compared to the baseline in the sequential parallel design|8 weeks therapy||||Participants|||Count of Participants
2705361|NCT01204918|Primary|Change in Montgomery and Asberg Depression Rating Scale (MADRS)|"This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|4 weeks of therapy (week 4 to week 8)||||units on a scale||Standard Deviation|Mean
2705362|NCT01204918|Primary|Change in Montgomery and Asberg Depression Rating Scale (MADRS)|"This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|4 weeks of therapy (baseline to week 4)||||units on a scale||Standard Deviation|Mean
2705363|NCT01204905|Secondary|Viral Suppression|Time to attainment of virologic suppression|48 weeks||||weeks|||Number
2705364|NCT01204905|Primary|Viral Load|Percentage of subjects with HIV-1 viral load < 50 copies/ml|48 weeks||||Participants|||Count of Participants
2705365|NCT01204853|Secondary|Number of Participants With Pharmacokinetic (PK) Parameters at Steady State|The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.|pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination|"The PK concentration set was defined as all participants who have at least 1 concentration.~The PK parameter analysis set was defined as all participants who have at least 1 of PK parameters of interest.~Descriptive statistics for PK parameters were not calculated due to a small number of participants."|||Participants|||Number
2705366|NCT01204853|Secondary|Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for clinical worsening were not calculated due to a small number of participants."|||Participants|||Number
2705367|NCT01204853|Secondary|Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in NT-pro BNP were not calculated due to a small number of participants."|||pg/mL||Standard Deviation|Mean
2705368|NCT01204853|Secondary|Number of Participants With Haemodynamics Parameters|"The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate.~Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline."|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in haemodynamics parameters were not calculated due to a small number of participants."|||Participants|||Number
2705369|NCT01204853|Secondary|Change From Baseline in WHO Functional Class|"The change from baseline in WHO functional class was classified into Improved, No change and Worsened. The change from baseline in WHO functional class at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12."|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in WHO functional class were not calculated due to a small number of participants."|||Percentage of participants|||Number
2705370|NCT01204853|Primary|Change From Baseline in 6-minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in 6-minute walk distance were not calculated due to a small number of participants."|||Meters||Standard Deviation|Mean
2705371|NCT01204853|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|12 weeks|"Safety analysis set is defined as all participants who receive at least one dose of the study drug.~Descriptive statistics for adverse events were not calculated due to a small number of subjects."|||Participant|||Number
2705372|NCT01204788|Primary|Number of Participants With Infection|Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.|Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.|Outcomes inevaluable due to low recruitment.||||||
2705373|NCT01204775|Primary|Mean Change in HbA1c From Baseline to Week 16||16 week short term treatment period||||percentage||Standard Deviation|Mean
2705374|NCT01204736|Primary|Elbow Extension Strength|Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.|At least one year post surgery||||Newton-Meters|Participants|Standard Deviation|Mean
2705375|NCT01204710|Secondary|Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3||Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle)|Zero participants were analyzed. An insufficient amount of samples were collected to obtain this measure.||||||
2705376|NCT01204710|Secondary|Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|From Start of Treatment up to 9 Months|All randomized participants who received ≥1 dose of study drug and had evaluable baseline and evaluable post-baseline antibody data. The participants analyzed under Mitoxantrone are those in control arm receiving subsequent optional olaratumab monotherapy.|||percent of participants|||Number
2705377|NCT01204710|Other Pre-specified|Number of Participants Who Died During Study||From Start of Treatment through Study Completion up to 36 Months|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2705378|NCT01204710|Secondary|Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)|"PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with positive and negative expression. Positive corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. Negative corresponds to staining that does not meet these requirements."|Baseline|All randomized participants who received at least 1 dose of study drug and provided tissue specimens from the initial diagnosis for PDGFRα protein expression analysis.|||participants|||Number
2705379|NCT01204710|Secondary|OS Based on Baseline CTC Counts|HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause.|Randomization to Death Due to Any Cause Up to 36 Months|All randomized participants who had evaluable data for CTC counts at baseline. The CTC counts assessment across both arms, high and low expression, was pre-specified in the statistical analysis plan.|||months||95% Confidence Interval|Median
2705400|NCT01204671|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Participants|||Count of Participants
2705380|NCT01204710|Secondary|PFS Based on Baseline Circulating Tumor Cells (CTC) Counts|High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause.|Randomization to Measured PD or Death Due to Any Cause Up to 23 Months|All randomized participants who had evaluable data for CTC counts at baseline. The CTC counts assessment across both arms, high and low expression, was pre-specified in the statistical analysis plan.|||months||95% Confidence Interval|Median
2705381|NCT01204710|Secondary|Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)|Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|From Start of Treatment Through Study Completion Up to 36 months|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2705382|NCT01204710|Secondary|Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12|Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100.|Pretreatment through Week 12|All randomized participants who received ≥1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2705383|NCT01204710|Secondary|Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time|Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100.|Pretreatment to PD Up to 23 Months|All randomized participants who received ≥1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2705384|NCT01204710|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100.|Randomization to Objective PD or Death Up to 23 Months|All randomized participants who received at least ≥1 dose of study drug and had measurable disease.|||percentage of participants||95% Confidence Interval|Number
2705385|NCT01204710|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive.|Randomization to Death Due to Any Cause Up to 36 Months|All randomized participants who received ≥1 dose of study drug. The number of participants censored was 12 for olaratumab + mitoxantrone group and 13 for mitoxantrone group.|||months||95% Confidence Interval|Median
2705386|NCT01204710|Primary|Progression-Free Survival (PFS)|PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment.|Randomization to Measured PD or Death Due to Any Cause Up to 23 Months|All randomized participants who received ≥1 dose of study drug. The number of participants censored was 10 for olaratumab + mitoxantrone group and 5 for mitoxantrone group.|||months||95% Confidence Interval|Median
2705387|NCT01204697|Secondary|Duration of Response (DoR)|Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death ‐ Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan‐Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population. Here, number of participants analyzed signifies those participants who had a best overall response of CR or PR.|||months||95% Confidence Interval|Median
2705388|NCT01204697|Secondary|Percentage of Participants With Disease Control|Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non‐responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2705398|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Participants|||Count of Participants
2705389|NCT01204697|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization until progressive disease or death, assessed up to 18 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2705390|NCT01204697|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan‐Meier method.|From randomization until death, assessed up to 18 months|FAS population|||months||95% Confidence Interval|Median
2705391|NCT01204697|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression‐free. Participants without post‐baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event ‐ Date of Randomization) + 1. PFS was assessed using the Kaplan‐Meier method. Detailed definition of PD is provided in Outcome Measure 1.|From randomization until progressive disease or death, assessed up to 18 months|FAS population|||months||95% Confidence Interval|Median
2705392|NCT01204697|Primary|Percentage of Participants Free From Disease Progression or Death at 6 Months|According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).|Month 6|FAS population|||percentage of participants||95% Confidence Interval|Number
2705393|NCT01204671|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2705394|NCT01204671|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2705395|NCT01204671|Secondary|Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2705396|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2705397|NCT01204671|Secondary|Number of Days With Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)].|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Day||Inter-Quartile Range|Median
2705399|NCT01204671|Secondary|Number of Days With Solicited Local Symptoms|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Day||Inter-Quartile Range|Median
2705650|NCT01202188|Secondary|Rate of Moderate or Severe COPD Exacerbation|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26 Weeks||||Exacerbations per year|||Number
2705401|NCT01204671|Secondary|Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease|"Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using fold increase as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure."|At Day 21 (D 21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||fold change||95% Confidence Interval|Geometric Mean
2705402|NCT01204671|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D 0), and at Day 21 (D 21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2705403|NCT01204671|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease|A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D 0), and at Day 21 (D 21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2705404|NCT01204671|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D 21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2705405|NCT01204671|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D 0), and at Day 21 (D 21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2705406|NCT01204658|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|During the entire study period (Months 0-11)|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.|||Participants|||Count of Participants
2705407|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.|||Participants|||Count of Participants
2705422|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|This analysis could not be performed as no validated assay was available.||||||
2709330|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705408|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.|||Participants|||Count of Participants
2705409|NCT01204658|Secondary|Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C.|Within the 7-day (Days 0-6) period post vaccination after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Participants|||Count of Participants
2705410|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Participants|||Count of Participants
2705411|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Participants|||Count of Participants
2705412|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
2705413|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
2705414|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
2705423|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|This analysis could not be performed as no validated assay was available.||||||
2705415|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
2705416|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. * A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||mIU/mL||95% Confidence Interval|Geometric Mean
2705417|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||mIU/mL||95% Confidence Interval|Geometric Mean
2705418|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2705419|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2705420|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||IU/mL||95% Confidence Interval|Geometric Mean
2705421|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||IU/mL||95% Confidence Interval|Geometric Mean
2707268|NCT01192152|Secondary|Metformin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2705424|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
2705425|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
2705426|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
2705427|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
2705428|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2705429|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2705441|NCT01204398|Primary|DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean|ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.|8 weeks|Full analysis set (FAS) defined as all patients with at least one dose of T80/A5, and for whom baseline and post-baseline ABPM are available.|||mmHg||Standard Deviation|Mean
2705442|NCT01204294|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.|Baseline and 52 weeks|The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available|||Percentage||Standard Deviation|Mean
2705430|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2705431|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2705432|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Percentage of participants|||Number
2705433|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Percentage of participants|||Number
2705434|NCT01204658|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Participants|||Count of Participants
2705435|NCT01204398|Secondary|Change From Baseline to End of Study in In-clinic Pulse Rate||8 weeks|TS with non-missing data|||beats per minute (bpm)||Standard Deviation|Mean
2705436|NCT01204398|Secondary|Treatment Emergent Adverse Events|Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events|8 weeks|Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5.|||Participants|||Number
2705437|NCT01204398|Secondary|ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing|DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment|0 and 8 weeks|FAS|||mmHg||Standard Deviation|Mean
2705438|NCT01204398|Secondary|Change From Baseline to End of Study in DBP and SBP|Manually measured in-clinic DBP and SBP|8 weeks|FAS|||mmHg||Standard Deviation|Mean
2705439|NCT01204398|Secondary|Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment|Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.|8 weeks|FAS|||Ratio||Full Range|Median
2705440|NCT01204398|Secondary|Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing|Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5|8 weeks|FAS|||mmHg||Standard Deviation|Mean
2705443|NCT01204294|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events|The first drug administration through 7 days after the last drug administration, up to 382 days|The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period|||Patients|||Number
2705444|NCT01204255|Secondary|Side Effects||3 months||||Total number of side effects|||Number
2705445|NCT01204255|Primary|Lorazepam, Diphenyhydramine, Haloperidol Absorption|Level of lorazepam absorption measured by the serum concentration of the drug|4 hours||||ng/ml||Standard Deviation|Mean
2705446|NCT01204203|Secondary|Overall Survival (OS)|Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.|Baseline up to 28 months|Participants with advanced malignant pleural mesothelioma.|||months||Full Range|Median
2705447|NCT01204203|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.|Baseline up to 28 months|Participants with advanced malignant pleural mesothelioma.|||Months||Full Range|Median
2705448|NCT01204203|Primary|Tumor Response Rate Following Zoledronic Acid (Zometa)|The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.|Baseline up to 28 months or until progressive disease or death|Participants with advanced malignant pleural mesothelioma.|||percentage of responders|||Number
2705449|NCT01203956|Secondary|Key Measures That Will be Used to Evaluate the Intervention(s)|The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device|2 weeks|||||||
2705450|NCT01203956|Primary|Apnea-hypopnea Index (AHI)|Number of apnea/hypopnea events per hour, measured by SmartLink component of device.|4 weeks||||events / hour||Standard Deviation|Mean
2705451|NCT01203930|Secondary|Overall Survival|Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause.|Up to 28 Months|Overall survival analysis was not performed because the follow-up period was insufficient to capture enough events.||||||
2705452|NCT01203930|Secondary|Changes in Potential Pharmacodynamic Markers of Drug Activity in Plasma and Whole Blood|"Changes in potential pharmacodynamic markers of drug activity will include assessments of chemokine and cytokine concentrations, effects on the activity of PI3K and related pathways, and effect on cell migration and other functional outcomes. This endpoint will be assessed at the following time points:~Idelalisib+Rituximab (Cohort 1): Predose and 1.5 hour postdose on Day 1 and predose on Days 15, 29, 57, 113, and 169~Idelalisib (Cohort 2): Predose on Days 1, 29, 57, 141"|Up to 169 days|The collection of plasma samples for pharmacodynamic (PD) analysis in this study was planned prior to the availability of results from an identical PD analysis in another idelalisib study with a larger sample size (n = 176 unique subjects with 2085 longitudinal plasma samples). Therefore, PD analysis was not performed in this study (n = 41).||||||
2705453|NCT01203930|Secondary|Idelalisib Plasma Concentrations (Cohort 2)||Predose and 1.5 hours postdose at Weeks 0 and 4 and predose at Weeks 8 and 20|PK Analysis Set: participants in the ITT Analysis Set from Cohort 2 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.|||ng/mL||Inter-Quartile Range|Median
2705454|NCT01203930|Secondary|Idelalisib Plasma Concentrations (Cohort 1)||Predose and 1.5 hours postdose at Weeks 0, 4, and 24|Pharmacokinetic (PK) Analysis Set: participants in the ITT Analysis Set from Cohort 1 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.|||ng/mL||Inter-Quartile Range|Median
2705455|NCT01203930|Secondary|Progression-Free Survival|"Progression-free survival (PFS) was defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause.~Progression was defined using the Standardized IWCLL criteria as specifically modified for this study to consider the mechanism of action of idelalisib and similar drugs. The occurrence of any of the following events indicated progression:~Evidence of any new disease~Evidence of worsening of index lesions, spleen or liver, or non-index disease~Decrease in platelet count or hemoglobin that is attributable to CLL and is confirmed by bone marrow biopsy"|Up to 28 Months|ITT Analysis Set|||months||95% Confidence Interval|Median
2705456|NCT01203930|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.|Up to 28 Months|Participants in the ITT Analysis Set who achieved complete or partial response.|||months||95% Confidence Interval|Median
2705457|NCT01203930|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of All Measurable Lesions||Baseline; Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96, 108, and 120|Participants in the ITT Analysis Set with available data were analyzed.|||percent change||Full Range|Median
2705458|NCT01203930|Secondary|Lymphadenopathy Response Rate|Lymphadenopathy response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in the sum of the perpendicular diameters of all measurable lesions while receiving study therapy.|Baseline and up to 28 Months|Participants in the ITT Analysis Set with baseline measurable lymph nodes were analyzed.|||percentage of participants||95% Confidence Interval|Number
2705459|NCT01203930|Secondary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|Up to 28 Months|ITT Analysis Set|||percentage of participants|||Number
2705488|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination|one month after the second vaccination|Accroding to Protocol set|||participants|||Number
2705460|NCT01203930|Primary|Overall Response Rate (ORR)|"ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymphadenopathy, liver and/or spleen size, constitutional symptoms, polymorphonuclear leukocytes, circulating clonal B-lymphocytes, platelet count, hemoglobin, and marrow were assessed.~CR: meeting all defined criteria~PR: meeting at least 2 of the criteria of circulating lymphocytes, lymphadenopathy, liver, spleen, or bone marrow (or only lymphadenopathy if liver and spleen normal at baseline) and at least 1 of the criteria for polymorphonuclear leukocytes, platelet count, or hemoglobin."|Up to 28 Months|Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib.|||percentage of participants||95% Confidence Interval|Number
2705461|NCT01203917|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Months||95% Confidence Interval|Median
2705462|NCT01203917|Other Pre-specified|Progression - Free Survival (PFS) (Independent Central Review)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Months||95% Confidence Interval|Median
2705463|NCT01203917|Secondary|Progression - Free Survival (PFS) (Investigator)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Months||95% Confidence Interval|Median
2705464|NCT01203917|Other Pre-specified|Objective Response Rate (ORR) (Independent Central Review))|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
2705465|NCT01203917|Other Pre-specified|Disease Control Rate (DCR) (Independent Central Review)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
2705466|NCT01203917|Secondary|Disease Control Rate (DCR) (Investigator)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
2705467|NCT01203917|Primary|Objective Response Rate (ORR) (Investigator)|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
2705489|NCT01203189|Secondary|Number of Participants Who Are Very Satisfied|"Patient satisfaction will be measured using a five point satisfaction scale.~very dissatisfied~dissatisfied~Neutral~satisfied~very satisfied."|data were collected at end of each treatment period (4 weeks and 8 weeks)|Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group.|||Participants|||Count of Participants
2705468|NCT01203878|Secondary|Cosmetic Appearance|"Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:~INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation~1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity"|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 investigator cosmetic appearance score. One imiquimod/observation patient did not have an end of study investigator cosmetic appearance score.|||units on a scale||Standard Deviation|Mean
2705469|NCT01203878|Secondary|Complete Clearance|The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).|Week 18 (4 weeks after randomization visit)|Randomized patients with a week 18 actinic keratosis count.|||participants|||Number
2705470|NCT01203878|Primary|Actinic Keratosis Count|The percent change in actinic keratosis count as compared to the baseline lesion count|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 actinic keratosis count. One patient in imiquimod/observation group did not have a baseline count and therefore was not included in the analysis.|||percent reduction in baseline count||Standard Deviation|Mean
2705471|NCT01203852|Secondary|Adverse Metabolic Effects|Change in glucose after treatment with study medication|after 6-8 weeks treatment|All patients with change in glucose data|||mg/dL||Standard Deviation|Mean
2705472|NCT01203852|Primary|Change in Blood Pressure From Baseline to Treatment|Response to blood pressure medication will be assessed by measuring blood pressure before and after treatment|after 6-8 weeks of treatment|All patients with antihypertensive response data. 282 patients completed all 3 study periods. 369 patients completed only period 1. 328 patients completed only period 3.|||mmHg||Standard Deviation|Mean
2705473|NCT01203826|Primary|Skeletal Radiograph Evaluation Using a Qualitative Radiographic Global Impression of Change (RGI-C) Scale Compared to Baseline (Pre-treatment) in Study ENB-006-09.|"Evaluation of radiographic change in rickets severity (as assessed by skeletal radiographs of the hands/wrists and knees) from the Baseline of Study ENB-006-09 (NCT00952484) to the End of Study (EOS) visit in Study ENB-008-10 using an ordinal RGI-C scale score. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP associated rickets) to +3 (indicative of complete or near complete healing of HPP associated rickets).~The time points will be pre-treatment (Baseline from Study ENB-006-09) to the last radiographic assessment in Study ENB-008-10, which represents at least 72 months of treatment."|At least 72 months of treatment with asfotase alfa|Each visit in Study ENB-008-10 was calculated relative to the start of exposure to asfotase alfa in Study ENB-006-09 (NCT00952484); 24 weeks are added to each visit in Study ENB-008-10. Results shown are for the last assessment in Study ENB-008-10 and represent at least 72 months of treatment with asfotase alfa.|||units on a scale||Full Range|Median
2705474|NCT01203787|Secondary|Number of Subjects With Dose Reductions||11/22/2010-3/10/2014||||participants|||Number
2705475|NCT01203787|Secondary|Number of Subjects With Dose Interruptions||Baseline-End of Treatment (11/22/2010-3/10/2014)||||participants|||Number
2705476|NCT01203787|Primary|Cumulative Dose of Sorafenib|Table below shows mean cumulative dose of sorafenib for each of the dosing regimens.|11/22/2010-1/27/14||||mg||Standard Deviation|Mean
2705477|NCT01203787|Secondary|Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 5 adverse events was collected for each dosing regimen beginning at baseline through 6 months of treatment.|11/22/2010-3/10/2014||||Grade 5 Adverse Events|||Number
2705478|NCT01203787|Secondary|Safety of Dosing Regimens as Assessed by the Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 4 adverse events was collected for each dosing regimen beginning at baseline until Week 24/Early Termination Visit.|11/22/2010-3/10/2014||||Grade 4 adverse events|||Number
2705479|NCT01203787|Secondary|Safety and Efficacy of Sorafenib Dosing Regimens|Safety of Sorafenib was assessed by the frequency and severity of adverse events according to NCI-CTCAE grading|Baseline-End of Treatment (11/22/2010-3/10/2014)|The total number of CTCAE (Common Terminology Criteria) grade 3 adverse events was collected for each dosing regimen|||Grade 3 adverse events|||Number
2705480|NCT01203787|Primary|Total (Cumulative) Dose Delivery of Sorafenib|This outcome measure table shows the median cumulative dose delivered to the subjects randomized to the standard dosing regimen (N=63) and ramp-up regimen (N=57) at 4 months of treatment.|4 months-1/12/2010-1/27/14||||mg||Full Range|Median
2705481|NCT01203644|Secondary|Adverse Events|Safety assessments included monitoring of treatment-emergent adverse events|Through 30 days postdose|||||||
2705482|NCT01203644|Primary|Time to First Use of Supplemental Pain Medication|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain|Through 96 hours postdose||||hours||Inter-Quartile Range|Median
2705483|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after third vaccination|within the first 30 days after third vaccination|||||||
2705484|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after second vaccination|within the first 30 days after second vaccination|||||||
2705485|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after first vaccination|within the first 30 days after first vaccination|||||||
2705486|NCT01203319|Secondary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination|one month after the first vaccination||||participants|||Number
2705487|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination|one month after the third vaccination||||participants|||Number
2705490|NCT01203189|Secondary|Number of Participants Who Are Always Compliant.|"Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit.~a patient is classified as always indicates that they use their medicine as directed on their diary on every visit."|at end of each treatment period (4 weeks and 8 weeks)|Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group.|||Participants|||Count of Participants
2705491|NCT01203189|Primary|Total Dandruff Severity Score (TDSS)|"The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score.~Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome"|up to 8 weeks|Data were not collected for the Shampoo only group and Foam Only group at 8 weeks. Only 3 participants completed the 8 weeks of cross over treatment.|||units on a scale||Standard Deviation|Mean
2705492|NCT01203098|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment|||percentage of subjects with bleeds||95% Confidence Interval|Number
2705493|NCT01203098|Primary|Percentage of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.|||percent of participants with VTE event||95% Confidence Interval|Number
2705494|NCT01203072|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug|2 weeks|Safety Analysis Set is defined as subjects secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any doses of study drug, or had no safety data after start of study treatment. Subjects with significant GCP violations, but received at least one dose of study drug, safety data were assessed individually|||percentage of subjects with bleeds||95% Confidence Interval|Number
2705495|NCT01203072|Primary|Proportion of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.|||percentage of participants||95% Confidence Interval|Number
2705496|NCT01203046|Primary|Other Complications|Patients with complications different to surgical site infection.|10 days|Patients who presented any complication different of surgical site infection after surgery|||participants|||Number
2705497|NCT01203046|Primary|Surgical Site Infection|The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.|10 days|All patients with inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption observed at surgical site were included.|||participants|||Number
2705498|NCT01202994|Secondary|Change in Participant Z-score|This z-scores is based on a test of visual learning and memory, which was administered to subjects twice across one week. The amount of change that individuals show across one week is the baseline measure assessed with this variable. We focused on the amount of change observed on the Delayed Recall trial of this test between baseline and one week (i.e., practice effect). The practice effect score on this test is represented as a z-score (M = 0, SD = 1), with higher scores indicating more improvement across one week, which is better result than lower scores.|baseline, one week||||z-score||Standard Deviation|Mean
2705499|NCT01202994|Primary|Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan.|Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.|Imaging occurred during a single session with each subject.||||ratio of flutemetamol absorbed||Standard Deviation|Mean
2705500|NCT01202955|Secondary|Correct Reaction Time During Attention Task Performance After Overnight Abstinence.|We wanted to examine the effects of Tolcapone on the Continuous Performance Task (attention task) after overnight abstinence as compared to placebo.|30 days|Only participants who completed both study phases were analyzed.|||Milliseconds||Standard Deviation|Mean
2705501|NCT01202955|Secondary|N-back (Working Memory) Correct Reaction Time After Overnight Abstinence.|To obtain preliminary data on the effects of Tolcapone on abstinence-induced neurocognitive deficits in abstinent smokers with differing COMT genotypes. We examined reaction time differences on the n-back task between tolcapone and placebo treatment.|30 days|Only participants who completed both sessions were analysed|||Milliseconds||Standard Deviation|Mean
2705502|NCT01202955|Primary|Number of Eligible Participants Enrolled Who Completed the Study.|Number of enrolled participants who complete the final study visit|30 days|Number of Participants who completed the study.|||Participants|||Number
2705503|NCT01202903|Secondary|Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment|Analysis of rescue medication use followed a similar method to that employed for total asthma symptom score. The mean number of puffs across the 28 days prior to the Week 24 assessment visit was used to calculate a change from baseline. LS Mean of change from baseline in mean number of puffs of asthma rescue medication is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean number of puffs of asthma rescue medication as covariates.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Number of puffs||Standard Error|Least Squares Mean
2705504|NCT01202903|Secondary|Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24|The global evaluation of treatment effectiveness (GETE) is an assessment of asthma symptom control and overall response to asthma treatment. The evaluation was performed by both investigator and patient, each using the same 5 point scale. The GETE scale ranges were as follows: excellent, good, moderate, poor and worsening. A good or excellent response on the 5 point scale indicated that a patient had responded to treatment. 1=excellent 2=good 3=moderate 4=poor 5= worsening. Responder is defined as the patient who achieved an excellent or good response. Non-responder isdefined as the patient who achieved a moderate or poor or worsening response.|16 and 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Percent|||Number
2705505|NCT01202903|Secondary|Change From Baseline in Asthma Symptom Scores Following 24-week Treatment|Total asthma symptom score was derived for each day as the total of the morning (scale 0-1), daytime (scale 0-4) and nocturnal (scale 0-4) scores with a max score of 9. The mean score across the 28 days prior to the week 24 assessment visit was used to calculate a change from baseline. Analysis of total asthma symptom score was performed using ANCOVA model and Van-Elteren test. LS Mean of change from baseline in mean asthma symptom score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean asthma symptom scores as covariates. Decrease of score on change from baseline means improvement of asthma symptom control.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Units on a scale||Standard Error|Least Squares Mean
2705506|NCT01202903|Secondary|Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator's site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. Only patients with no more than 1 item missing are included, and the missing item was imputed by interpolation|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Percent|||Number
2705507|NCT01202903|Secondary|Change From Baseline in ACQ Score Following 24-week Treatment|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator's site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. LS Mean of change from baseline in ACQ score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, center grouping, smoking status, and baseline ACQ score as covariates. Score 0= totally controlled, 6= extremely poorly controlled|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Units on a scale||Standard Error|Least Squares Mean
2705508|NCT01202903|Secondary|Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients' asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Percent|||Number
2705509|NCT01202903|Secondary|Change From Baseline in AQLQ Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients' asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Units on a scale||Standard Error|Least Squares Mean
2705510|NCT01202903|Secondary|Change From Baseline in % Predicted FEV1 Following 24-week Treatment|Spirometry was used at defined time points throughout the study to assess the clinical status of patients and to capture the following variables: forced expiratory volume in one second (FEV1), FEV1 percent predicted, forced vital capacity (FVC) and the FEV1/FVC ratio. During the Screening assessment, spirometry was performed pre- and post-bronchodilator administration to assess reversibility. During the treatment period (including prerandomization assessments on Day 1), spirometry was performed after withholding bronchodilators. The results of spirometry were required to meet the ATS/ERS criteria for acceptability and repeatability. Acceptability criteria were applied before repeatability was determined. LS Mean of change from baseline in % predicted FEV1 is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline % predicted FEV1 as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||L/min||Standard Error|Least Squares Mean
2705511|NCT01202903|Secondary|Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||L/min||Standard Error|Least Squares Mean
2705512|NCT01202903|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||L/min||Standard Error|Least Squares Mean
2705513|NCT01202877|Primary|Overall Response (OR) Within 6 Months|Overall response defined as number of participants with response as follows: (OR = CR [complete response (CR) rate] + CRi [complete remission with incomplete count recovery] + PR [partial remission] + HI [hematologic improvement]) within 6 months of treatment initiation. complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: <5% bone marrow blasts, neutrophil count>1.0 X10⁹/L, & platelet count>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (<1.0 X10⁹/L) or thrombocytopenia (<100 X10⁹/L). MLFS: <5% blasts in bone marrow regardless of neutrophil & platelet count in peripheral blood. PR: all CR criteria, except reduction> 50% in bone marrow blasts, but still >5%.|6 Months||||participants|||Number
2705514|NCT01202877|Primary|Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|Criteria for response per international working group for Myelodysplastic Syndrome (MDS) & acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: <5% bone marrow blasts, neutrophil count>1.0 X10⁹/L, & platelet count>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (<1.0 X10⁹/L) or thrombocytopenia (<100 X10⁹/L). MLFS: <5% blasts in bone marrow regardless of neutrophil & platelet count in peripheral blood. PR: all CR criteria, except reduction> 50% in bone marrow blasts, but still >5%. Clinical responses evaluated using RECIST version 1.1 criteria after every two cycles, with confirmation of clinical response at 4 weeks after achieving response.|6 months||||participants|||Number
2705515|NCT01202773|Secondary|Change From Baseline to Week 24 in CRP|CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||milligrams/liter (mg/L)||Standard Error|Least Squares Mean
2705516|NCT01202773|Secondary|Percentage of Participants Developing Anti-LY2127399 Antibodies|Participants with treatment-emergent anti-drug antibody (ADA) were participants who had any sample from baseline up to and through Week 52 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA = (number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.|Baseline through Week 24|All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2705517|NCT01202773|Secondary|Population Pharmacokinetics (PK): Constant Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|Baseline through Week 24|All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliters/hour (mL/h)||Standard Error|Mean
2705518|NCT01202773|Secondary|Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels|Immunoglobulin (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||grams/liter (g/L)||Standard Error|Least Squares Mean
2705519|NCT01202773|Secondary|Change From Baseline to Week 24 in Absolute B Cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||cells/microliter (cells/µL)||Standard Error|Least Squares Mean
2705520|NCT01202773|Secondary|Time to ACR20 Response||Baseline through Week 24|Zero participants analyzed. Time to ACR20 data not collected for analysis.||||||
2705521|NCT01202773|Secondary|Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)|The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||minutes||Standard Error|Least Squares Mean
2705522|NCT01202773|Secondary|Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores|The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24 hours and pain based on the pain right now, with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in the past 24 hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2705523|NCT01202773|Secondary|Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores|The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, the first item is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2705524|NCT01202773|Secondary|Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. If < 50% of the questions within a domain were answered, the raw score were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher score indicating better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2705540|NCT01202760|Secondary|Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint|CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||milligrams per liter (mg/L)||Standard Error|Least Squares Mean
2705525|NCT01202773|Secondary|Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response|EULAR Responder index categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP=0.56*sqrt(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response = ( number of participants with specific response) / (number of participants analyzed in the group) * 100.|Baseline through Week 24|All randomized participants with evaluable EULAR response data. Modified Last Observation Carried Forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2705526|NCT01202773|Secondary|Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter), and participant's global assessment of disease activity using VAS (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2705527|NCT01202773|Secondary|Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2705528|NCT01202773|Secondary|Change From Baseline to Week 24 in Physician's Global Assessment of Disease Activity (VAS)|Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
2705529|NCT01202773|Secondary|Change From Baseline to Week 24 in Participant's Global Assessment of Disease Activity (VAS)|Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
2705530|NCT01202773|Secondary|Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]|Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
2705531|NCT01202773|Secondary|Change From Baseline to Week 24 in Swollen Joint Count (66 Joint Count)|Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
2705532|NCT01202773|Secondary|Change From Baseline to Week 24 in Tender Joint Count (68 Joint Count)|Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
2705566|NCT01202578|Primary|Safety of Tympanostomy Tube (TT) Delivery System|Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.|7 days|Subjects in whom TTDS was attempted.|||percentage of ears|Participants|95% Confidence Interval|Number
2705533|NCT01202773|Secondary|American College of Rheumatology Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJC, b) % change in SJC, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline Disease Activity Score based on 28 joint counts -CRP (DAS28-CRP) as a covariate.|Baseline through Week 24|All randomized participants with evaluable ACR-N data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of improvement||Standard Error|Least Squares Mean
2705534|NCT01202773|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|ACR Responder Index: composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had a ≥50% improvement from baseline in both 68 TJC and 66 SJC and a ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response = [number (No.) of ACR50 responders / No. of Pts treated]*100. ACR70 Responder: had a ≥70% improvement from baseline in both TJC and SJC and a ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response = (No. of ACR70 responders / No. of Pts treated)*100. All NR at Week 16, as well as all Pts who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.|Baseline through Week 24|All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2705535|NCT01202773|Primary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response = (number of ACR20 responders / number of participants treated) * 100. All NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.|Baseline through Week 24|All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2705536|NCT01202760|Secondary|Percentage of Participants Developing Anti-LY2127399 Antibodies|LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Baseline through 24 weeks|All randomized participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2705537|NCT01202760|Secondary|Population Pharmacokinetics (PK)|Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.|Baseline through 24 weeks|Participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliter per hour (mL/h)||95% Confidence Interval|Mean
2705538|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants who received at least 1 dose of study treatment with evaluable serum immunoglobulin (Ig) data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values.|||grams per liter (g/L)||Standard Error|Least Squares Mean
2705539|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants who received at least 1 dose of study treatment with evaluable absolute B-cell data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||cells per microliter||Standard Error|Least Squares Mean
2705592|NCT01202253|Secondary|Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants|||Number
2705541|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical health [PCS]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable SF-36 domain and summary scores. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
2705542|NCT01202760|Secondary|Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response|EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP <=5.1 and DAS28-CRP change <-0.6; or DAS28-CRP >5.1 and DAS28-CRP change <-1.2. EULAR28 responder index is defined as good response: DAS28-CRP <=3.2 and DAS28-CRP change <-1.2; moderate response: DAS28-CRP change <-1.2 except cases defined in good response; or DAS28-CRP <=5.1 and DAS28-CRP change <-0.6 and >-1.2. EULAR Remission is defined as a DAS28-CRP score of <2.6.|Up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||percentage of participants|||Number
2705543|NCT01202760|Secondary|Probability of an ACR20 Response by 24 Weeks|"ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:~(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7."|Baseline through 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.|||probability of response|||Number
2705544|NCT01202760|Secondary|Time to American College of Rheumatology 20% (ACR20) Response|"ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:~(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7."|Baseline through 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.|||weeks||95% Confidence Interval|Median
2705545|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable HAQ-DI data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
2705559|NCT01202656|Primary|Embryo Implantation and Clinical Pregnancy Rates|"Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred~Clinical pregnancy:~Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer"|26 to 30 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.|||Gestational sacs|Participants||Number
2705560|NCT01202643|Secondary|Implantation Rate|Number of gestational sacs per number of embryos transferred in each treatment group|28 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.|||Gestational sacs|embryos transferred||Number
2705561|NCT01202643|Primary|Endometrial Thickness|Thickness of the endometrium on the day of embryo transfer|Day of embryo transfer||||mm||Standard Deviation|Mean
2705546|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants, even if participant did not take assigned treatment, did not receive correct treatment, or otherwise did not follow protocol, with evaluable DAS28-CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
2705547|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)|Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable physician’s global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||millimeters||Standard Error|Least Squares Mean
2705548|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)|Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant’s global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||millimeters||Standard Error|Least Squares Mean
2705549|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)|Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant’s assessment of pain data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||millimeters||Standard Error|Least Squares Mean
2705550|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)|Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable swollen joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||joint count||Standard Error|Least Squares Mean
2705551|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)|Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable tender joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||joint count||Standard Error|Least Squares Mean
2705562|NCT01202591|Primary|Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)||3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).|All patients who receive at least one dose of study treatment (AZD4547 or exemestane)|||Participants|||Number
2705563|NCT01202578|Secondary|Tube Retention|Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.|7 days|Tube retention was assessed for all TT successfully placed by the TTDS|||percentage of tubes retained|Participants|95% Confidence Interval|Number
2705564|NCT01202578|Secondary|Proportion of Subjects With Procedure Success|Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.|0 days||||percentage of participants||95% Confidence Interval|Number
2705552|NCT01202760|Secondary|Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If >=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.|Up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR-N data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
2705553|NCT01202760|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had >=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and >=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)*100. ACR70 Responder: had >=70% improvement from baseline in both TJ and SJ counts and >=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.|Up to 24 weeks|All randomized participants with at least 5/68 TJ and 5/66 SJ at baseline and with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included.|||percentage of participants|||Number
2705554|NCT01202760|Primary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >=20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.|Up to 24 weeks|All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable ACR20 data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included.|||percentage of participants|||Number
2705555|NCT01202747|Primary|Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)|"Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.~Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction."|Baseline and 4 Weeks|Results presented are for the Intent to Treat population.|||Correlation coefficient|||Number
2705556|NCT01202721|Secondary|Rate of Change in Ascending Aorta Size Evaluated by Transthoracic Echocardiography (TEE)|Rate of change in ascending aorta size evaluated by transthoracic echocardiography (ECHO) at 3 years. Change is measured in centimeters squared (final measurement - baseline measurement). Time frame was scheduled for 5 years, however due to poor study participant and site recruitment study was closed early and final outcome measures taken at approximately 3 years.|The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)|Discrepancy exists between participant flow numbers and patients analyzed for the following reasons: patients completed final visit over the phone where aortic root size cannot be measured; patients refused a final visit, patient's information was received through a third party. Pt's not removed as they are still included in other analyses|||centimetres squared||Standard Deviation|Mean
2705557|NCT01202721|Primary|Change From Baseline in Ascending Aorta Size, as Evaluated by MRI|The primary analyses include the evaluation of the effects of monotherapy (atenolol vs. placebo, telmisartan vs. placebo) on the change in aortic root size measured at 3 years. Change is measured in centimeters squared (final measurement - baseline measurement). Original outcome measure time frame was scheduled for 5 years, however due to poor study participant and site recruitment study was closed early and final outcome measures taken at approximately 3 years.|The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)|Intention to treat analysis method followed: patients completed final visit over the phone where aortic root size cannot be measured; patients refused a final visit, or patient's information was received through a third party. Patients missing primary outcome measures still followed for other analyses.|||centimeters squared||Standard Deviation|Mean
2705558|NCT01202656|Secondary|Live Birth Rates|Live birth rates among normal infertile couples undergoing IVF|Within nine months of embryo transfer||||Live Birth|||Number
2705565|NCT01202578|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.|0 days|Device Success is evaluated on a per device basis.|||percentage of devices|Participants|95% Confidence Interval|Number
2705567|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Quality of Life|Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.|||correlation coefficient|||Number
2705568|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.|||correlation coefficient|||Number
2705569|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.|||correlation coefficient|||Number
2705570|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.|||correlation coefficient|||Number
2705571|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.|||correlation coefficient|||Number
2705572|NCT01202565|Secondary|Change From Baseline in DLQI Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline DLQI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
2705573|NCT01202565|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.|||percent change||Standard Deviation|Mean
2705574|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 50 Response|"The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705593|NCT01202253|Secondary|Number of Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||events|||Number
2705575|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 75 Response|"The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705576|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 90 Response|"The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705577|NCT01202565|Secondary|Change From Baseline in PASI Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
2705578|NCT01202565|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.|||percent change||Standard Deviation|Mean
2705579|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Scalp|Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.|Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705580|NCT01202565|Secondary|Percentage of Participants Achieving Good Clinical Response on Scalp|"Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score.~The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area."|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705581|NCT01202565|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
2705594|NCT01202253|Secondary|Duration of Anidulafungin Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||days||Standard Deviation|Mean
2705595|NCT01202253|Secondary|Number of Participants With Other Dosing Patterns|The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
2705582|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Nails|"Complete clearing of nails is defined as a total NAPSI score of zero.~The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705583|NCT01202565|Secondary|Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis|"Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score.~The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
2705584|NCT01202565|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).~A negative change from Baseline indicates improvement."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
2705585|NCT01202565|Primary|Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12|"The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.~Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2705586|NCT01202565|Primary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).~Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Nail Psoriasis set, which includes participants with a Baseline NAPSI score ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2705587|NCT01202409|Secondary|Overall Progression-free Survival (PFS) for CAPOX and Panitumumab|Time interval in months from date of first treatment until the date of first documented progression of participants.|7.6 months||||months||Full Range|Median
2705588|NCT01202409|Primary|Response Rate (RR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 100 weeks||||Participants|||Count of Participants
2705589|NCT01202279|Primary|Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).|WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.|Baseline and 7 Days||||units on a scale||Standard Deviation|Mean
2705590|NCT01202279|Primary|Antibiotic Sparing|Number of patients who received an antibiotic|Day 7|Per Protocol Population using Fishers Exact Test.|||Participants|||Number
2705591|NCT01202253|Secondary|Number of Participants With Different Types of Drug-related Serious Adverse Events||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
2705607|NCT01202253|Secondary|Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705608|NCT01202253|Secondary|Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705609|NCT01202253|Secondary|Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705610|NCT01202253|Secondary|Dose Changes for Immunosuppressant Drugs||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.||||||
2705611|NCT01202253|Secondary|Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705612|NCT01202253|Secondary|Percentage of Participants With Concomitant Bacterial or Viral Infection|Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705613|NCT01202253|Secondary|Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705614|NCT01202253|Secondary|Duration of Stay at Liver Intensive Therapy Unit (LITU)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Inter-Quartile Range|Mean
2705615|NCT01202253|Secondary|Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705616|NCT01202253|Secondary|Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.||||||
2705617|NCT01202253|Secondary|Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy|Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705618|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705619|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705620|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results|A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705621|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results|An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705624|NCT01202253|Secondary|Percentage of Participants Requiring Change or Additional Antifungal Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705625|NCT01202253|Secondary|Percentage of Participants With Lack of Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2705626|NCT01202253|Secondary|Percentage of Participants With Favorable Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2705627|NCT01202253|Secondary|Percentage of Participants With Death Unrelated to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705628|NCT01202253|Secondary|Percentage of Participants With Death Attributable to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants|||Number
2705629|NCT01202253|Secondary|Percentage of Participants Who Died Due to All Causes|Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2705630|NCT01202253|Secondary|Percentage of Participants With Unfavorable Outcome|Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2705631|NCT01202253|Primary|Percentage of Participants With Favorable Outcome|Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2705632|NCT01202227|Secondary|Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score|"The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.~Change = observation mean at Week 52 minus baseline mean."|Baseline, Week 52|"The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available.~The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101)."|||Score on a scale||95% Confidence Interval|Mean
2705633|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).|||Score on a scale||95% Confidence Interval|Mean
2705634|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).|||Score on a scale||95% Confidence Interval|Mean
2705635|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).|||Score on a scale||95% Confidence Interval|Mean
2705636|NCT01202227|Primary|Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)|The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705637|NCT01202227|Primary|Number of Participants With Deterioration in Neurological Examination Findings|Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705638|NCT01202227|Primary|Number of Participants With Visual Field Deteriorated|Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705639|NCT01202227|Primary|Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705640|NCT01202227|Primary|Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705641|NCT01202227|Primary|Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705642|NCT01202227|Primary|Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705643|NCT01202227|Primary|Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705644|NCT01202227|Primary|Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705645|NCT01202227|Primary|Number of Participants With Generalized or Abdominal Edema|Number of participants who had generalized or abdominal edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705646|NCT01202227|Primary|Number of Participants With Facial/Periorbital Edema|Number of participants who had facial or periorbital edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705647|NCT01202227|Primary|Number of Participants With Peripheral Edema|Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
2705651|NCT01202188|Secondary|24 Hour Holter Monitoring in a Subset of Patients|"24-hourly mean heart rate was performed using a Holter Monitor at Weeks 12 and 26 in a subgroup of patients. Mixed model: heart rate = treatment + baseline heart rate + baseline smoking status + baseline ICS use + region + center (region) + error. Center was included as a random effect nested within region.~The 24-hourly mean heart rate is the mean heart rate over the 24 hour period, derived using hourly mean heart rate beats per minute."|Week 12, Week 26|Safety Set Holter Group-a subset of the Safety participants that included all randomized participants who received at least one dose of study drug and participated in the 24 hour Holter monitoring with evaluable data available for analysis. No participants in the Titotropium arm participated in the Holter Monitoring.|||beats per minute||Standard Error|Least Squares Mean
2705652|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12, 23 hours 15 minutes and 23 hours 45 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 23 hours 45 minutes post-dose Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
2705653|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 12 hours post-dose Day 1 and Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
2705654|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 4 hours post-dose Day 1 and Week 26|Participants from full analysis set, all randomized participants who received study drug, with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from analysis.|||Liters||Standard Error|Least Squares Mean
2705655|NCT01202188|Secondary|"Percentage of Days With no Rescue Medication Use Over 26 Weeks"|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the full analysis set (all randomized participants who received at least one dose of study drug) with evaluable data (at least 40 days of diary data) available for analysis.|||Percentage of days||Standard Error|Least Squares Mean
2705656|NCT01202188|Secondary|Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs in the morning and evening were calculated and divided by the number of days with data to determine the mean daily number of daytime and nighttime puffs. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline (BL) ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.|||Puffs||Standard Error|Least Squares Mean
2705691|NCT01201967|Secondary|Change in Physical Function From Baseline to 24 Weeks|Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
2705703|NCT01201811|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|Timeframe: Day 7 pre-dose at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
2705657|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 12, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis at Week 12 and Week 26.|||Puffs per day||Standard Error|Least Squares Mean
2705658|NCT01202188|Secondary|"Percentage of Days Able to Perform Usual Daily Activities Over 26 Weeks"|"Patients answered the question Did your respiratory symptoms stop you performing your usual activities today?-Not at all in their daily diary. The percentage of days is calculated by the number of days patient is able to perform daily activities/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of Days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect."|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.|||Percentage of days||Standard Error|Least Squares Mean
2705659|NCT01202188|Secondary|"Percentage of Days With No Daytime Symptoms Over 26 Weeks"|A day with no day time symptoms is defined from the diary data as any day where the patient recorded no coughing, no wheezing, no sputum production and no breathlessness during the previous 12 hours (approximately 8AM to 8PM). The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.|||Percentage of days||Standard Error|Least Squares Mean
2705660|NCT01202188|Secondary|"Percentage of Nights With No Night Time Awakenings Over 26 Weeks"|A day with no night time awakenings is defined from the diary data as any day where the patient did not wake up due to COPD symptoms. The percentage of nights is calculated by the number of days with no nighttime awakenings/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.|||Percentage of nights||Standard Error|Least Squares Mean
2705661|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status.|Baseline, Week 26|Participants from the Full Analysis Set, that included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Percentage of participants|||Number
2705662|NCT01202188|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Score on a scale||Standard Error|Least Squares Mean
2705663|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing) at Week 12 and Week 26. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. The BDI (baseline) was measured at Day 1. The TDI captures changes from baseline. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9.|Baseline, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.|||Percentage of participants|||Number
2707237|NCT01192282|Primary|Number of HPV Genotypes Isolated by HIV Status|Number of HPV Genotypes isolated according to HIV Status|Up to 18 months|119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.|||participants|||Number
2705664|NCT01202188|Secondary|Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26|"A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.~A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators as covariates and included baseline smoking status, baseline inhaled corticosteroids and region as fixed effects with center nested within region as a random effect."|Baseline, Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Score on a scale||Standard Error|Least Squares Mean
2705665|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Per-protocol Set, randomized participants who received at least one dose of study drug without major protocol deviations. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
2705666|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
2705667|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.|||Puffs per day||Standard Error|Least Squares Mean
2705668|NCT01202188|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 weeks|Participants from the Full Analysis Set,included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Score on a scale||Standard Error|Least Squares Mean
2705669|NCT01202188|Secondary|Transitional Dyspnea Index (TDI) Focal Score at Week 26|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.|||Score on a scale||Standard Error|Least Squares Mean
2705702|NCT01201811|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|Timeframe: Days 5 and 6 at predose and Day 7 (pre-dose) at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2705670|NCT01202188|Primary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
2705671|NCT01202175|Secondary|Plasma Interleukin Levels||Basline (visit 1) and 8 weeks (visit 2)||||pg/ mL||Standard Deviation|Mean
2705672|NCT01202175|Secondary|Urinary Hydrogen Peroxide Excretion||Baseline (visit 1) and 8 Weeks (visit 2)||||umol/ mg Cr||Standard Error|Mean
2705673|NCT01202175|Secondary|Urinary Isoprostane Excretion||Basline (visit 1) and 8 weeks (visit 2)||||pg/ mg Cr||Standard Deviation|Mean
2705674|NCT01202175|Secondary|Urinary Nitric Oxide Excretion||Basline (visit 1) and 8 weeks (visit 2)||||umol/ mg Cr||Standard Deviation|Mean
2705675|NCT01202175|Primary|Heart Rate, Beats Per a Minute||Basline (visit 1) and 8 weeks (visit 2)||||beats per a minute||Standard Deviation|Mean
2705676|NCT01202175|Primary|Pulse Wave Velocity||Basline (visit 1) and 8 weeks (visit 2)||||m/s||Standard Deviation|Mean
2705677|NCT01202175|Primary|Aortic Augmentation Index for Heart Rate||Basline (visit 1) and 8 weeks (visit 2)||||percentage||Standard Deviation|Mean
2705678|NCT01202175|Primary|Aortic Augmentation Pressure||Basline (visit 1) and 8 weeks (visit 2)||||mm Hg||Standard Deviation|Mean
2705679|NCT01202175|Primary|Aortic Pulse Pressure||Basline (visit 1) and 8 weeks (visit 2)||||mm Hg||Standard Deviation|Mean
2705680|NCT01202175|Primary|Aortic Mean Arterial Pressure (MAP)||Basline (visit 1) and 8 weeks (visit 2)||||mm Hg||Standard Deviation|Mean
2705681|NCT01202175|Primary|Aortic Diastolic Blood Pressure (DBP)||Basline (visit 1) and 8 weeks (visit 2)||||mm Hg||Standard Deviation|Mean
2705682|NCT01202175|Primary|Aortic Systolic Blood Pressure (SBP)||Basline (visit 1) and 8 weeks (visit 2)||||mm Hg||Standard Deviation|Mean
2705683|NCT01202162|Secondary|Quality of Recovery 40|Survey completion at 24 hours post surgery of the Quality of Recovery 40 questionnaire.This questionnaire asks 40 questions in 5 categories of recovery. The scores are combined from each group and are used as a composite score. The scores range from a low of 40 to a high of 200. A score of 40 would indicate a poor quality of recovery where as a score of 200 would be a good quality of recovery at 24 hours postoperative.|1 day|In the Desflurane group 35 completed the survey 24 hours postoperative where as 33 in the Sevoflurane completed the survey during the postoperative period.|||score (between 40 low-200 high)||Inter-Quartile Range|Median
2705684|NCT01202162|Secondary|Number of Participants Who Coughed||Perioperative||||participants|||Number
2705685|NCT01202162|Primary|Time to Awakening||Time inhalational agent is turned off to time of patient awakening||||Elapsed time in minutes||Inter-Quartile Range|Median
2705686|NCT01202110|Primary|Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.|The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment.|24 months|Terminated prior to enrolling||||||
2705687|NCT01202071|Secondary|Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])|"Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).~Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)||||ng*h/mL||Standard Deviation|Mean
2705688|NCT01202071|Secondary|Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)|"Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).~Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV||||ng/mL||Standard Deviation|Mean
2705689|NCT01202071|Primary|Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration|The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.|Day 5 of administration during Period I-IV||||Percentage of Time in a 24 Hour Period||Standard Deviation|Mean
2705690|NCT01201967|Secondary|Change in Physical Health-related Quality of Life From Baseline to 24 Weeks|Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.|Baseline, 24 weeks||||units on a scale||95% Confidence Interval|Mean
2705692|NCT01201967|Secondary|Change in Health Status From Baseline to 24 Weeks|Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
2705693|NCT01201967|Secondary|Number of Rehospitalizations From Baseline to 24 Weeks|The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call.|24 weeks||||readmissions|||Number
2705694|NCT01201967|Secondary|Change in Adherence to Health Behaviors From Baseline to 24 Weeks|Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
2705695|NCT01201967|Secondary|Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment|"Adequate treatment was defined as:~(1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study).~Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as:~(1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm).~Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||participants|||Number
2705696|NCT01201967|Secondary|Change in Anxiety Symptoms From Baseline to 24 Weeks|Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
2705697|NCT01201967|Secondary|Change in Depression Symptoms From Baseline to 24 Weeks|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
2705698|NCT01201967|Primary|Change in Mental Health-related Quality of Life From Baseline to 24 Weeks|Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
2705699|NCT01201915|Secondary|Time to Complete Clinical Clearance|Time to complete clinical clearance was defined as the time from the first treatment with vismodegib until complete clinical clearance as determined by the investigator.|Baseline to the end of the study (up to 12 weeks for Cohort 1; up to 36 weeks for Cohort 2, up to 20 weeks for Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug. Only participants who achieved complete clinical clearance were included in the analysis.|||Days||95% Confidence Interval|Median
2705700|NCT01201915|Primary|Percentage of Participants With Complete Histologic Clearance|Complete histologic clearance was defined as the absence of histological evidence of basal cell carcinoma at the target tumor site. Histological examination was performed by an independent pathologist on specimens collected within 2 weeks of the end of treatment period, ie, at 12 weeks after Baseline in Cohort 1, at 36 weeks after Baseline in Cohort 2, and at 20 weeks after Baseline in Cohort 3.|Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2705701|NCT01201811|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2707238|NCT01192282|Primary|HPV DNA and Pap Smear Results|Relationship between HPV DNA Positivity and Pap Smear Results|18 Months|Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.|||Participants|||Number
2705704|NCT01201811|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
2705705|NCT01201811|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2705706|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2705707|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ was not reported.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2705708|NCT01201811|Secondary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Treatment Emergent AEs (TEAE) were defined as AEs with an onset date on or after the first dose of study drug and within 28 days after the date of the last dose. In addition, any AE that occurred beyond this timeframe and that was assessed by the investigator as possibly related to study drug was considered a TEAE."|From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study drug 244 days)|Safety Population included enrolled participants who received at least one dose of investigational product and had at least one postdose assessment|||participants|||Number
2705709|NCT01201811|Secondary|Number of Infections (Post-baseline Average) Requiring Intravenous Antibiotics, Anti-fungals, or Antivirals Per 28 Days|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle. For each participant the overall post-baseline average was calculated as the average of # of infections requiring IV antibiotics or IV antiviral per 28 days per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.|||Infections per cycle||Standard Deviation|Mean
2705710|NCT01201811|Secondary|Number of Platelet Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of platelet transfusions per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.|||Transfusions||Standard Deviation|Mean
2705711|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered platelet transfusion independent at baseline if the participant had no platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) participants who were transfusion independent|||percentage of particpants||95% Confidence Interval|Number
2705712|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered platelet transfusion dependent at baseline if the participant had one or more platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population who were transfusion dependent|||percentage of participants||95% Confidence Interval|Number
2709331|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non-Q-wave)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705713|NCT01201811|Secondary|Number of Red Blood Cell (RBC) Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study were standardized per 28 days and summarized by cycle for RBCs. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of RBC transfusions per cycle.|Up to week 24;The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|ITT Population- The intent-to-treat (ITT) population was defined as all enrolled participants.|||Transfusions||Standard Deviation|Mean
2705714|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered RBC transfusion-independent at baseline if the participant had no RBC transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no RBC transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The Intent to Treat (ITT) participants who were transfusion independent|||percentage of participants||95% Confidence Interval|Number
2705715|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered transfusion dependent at baseline if the participant had one or more Red Blood Cell transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no transfusions during any 56 consecutive days or more (e.g., Day 1 through 56, Day 2 through 57, etc). Otherwise, they were considered transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit|The intent-to-treat (ITT) participants who were transfusion dependent|||percentage of participants||95% Confidence Interval|Number
2705716|NCT01201811|Primary|Percentage of Participants Showing Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Sponsor|"Hematologic improvements (HI) have 4 categories:~Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor- 10-20g/L increase or ≥50% decrease in transfusion requirements.~Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor-≥50% increase.~Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor-≥100% increase and absolute increase of <0.5x10^9/L~Progression or relapse after HI~Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data.~Denominator for progression/relapse after HI included participants who had achieved HI."|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2705717|NCT01201811|Primary|Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator|"Hematologic Response according to the 2000 International Working Group (IWG) response criteria for MDS was based on the Investigators determination and defined as:~Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia~Partial Response (PR): same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment~Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months.~Failure: death during treatment or disease progression~Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence~Disease Progression: change in blast levels~Disease Transformation to AML"|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2705718|NCT01201798|Secondary|Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits|The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
2705719|NCT01201798|Secondary|Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points|The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
2705720|NCT01201798|Secondary|Proportion of Subjects Who Discontinued Due to Lack of Efficacy|Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.|Time to Event|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications.|||Percentage of subjects|||Number
2705721|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade ≤1|As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
2705722|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
2705723|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
2705724|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
2705725|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points|Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
2705726|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
2705727|NCT01201798|Primary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 14|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
2705728|NCT01201785|Primary|Collagen Induced Aggregation|Collagen induced aggregation using light transmittance aggregometry|after 1 -week of treatment|A 20% SD for the difference between collagen-induced platelet aggregation in patients on aspirin 81 mg od versus 81 mg bid was assumed, and based on a power of 80% and a significance level of 0.05. Based on these values, we determined that a sample population of 20 patients would be needed.|||percentage of platelet aggregation||Standard Deviation|Mean
2705729|NCT01201772|Primary|PRI Levels at 4 Hours||4 hours after treatment|A total of 65 patients were randomized. One patient assigned to the 10mg prasugrel group was withdrawn after randomization due to anemia identified after baseline blood sampling. Finally, 64 patients [10 mg (n=22), 30 mg (n=21) and 60 mg (n=21)] completed all time periods of the study.|||percentage of platelet reactivity||Standard Error|Mean
2705730|NCT01201759|Secondary|Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5|"The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting).~For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject's factors."|Study visit at min -30 (fasting)|All enrolled participants who completed the study.|||mg/dL||Standard Deviation|Mean
2705731|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min.~For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors."|Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.|||mg*min/dL||Standard Deviation|Mean
2705732|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min.~For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors."|Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All participants who completed treatment.|||mg*min/dL||Standard Deviation|Mean
2705733|NCT01201759|Primary|Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min.~For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors."|Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.|||mg*min/dL||Standard Deviation|Mean
2705734|NCT01201629|Secondary|Discharge Disposition|Patient discharged home or to sub-acute facility|after 4 weeks of intervention||||Participants|||Count of Participants
2705735|NCT01201629|Secondary|Action Research Arm Test (ARAT) Change Scores|The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal|baseline to after 4-weeks of therapy||||units on a scale||Standard Deviation|Mean
2705736|NCT01201629|Primary|Total Functional Independence Measure (TFIM) Change Scores|"The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as complete independence, while a score of one is total assist (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence."|from baseline to 4-weeks of therapy||||units on a scale||Standard Deviation|Mean
2705737|NCT01201486|Primary|Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy|The number of *fetuses with* heart defects detected by color Doppler in the second trimester was compared to the number of *fetuses with* major heart defects detected at birth.|2nd trimester||||fetuses|||Number
2705738|NCT01201356|Secondary|Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)|The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed.|Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||EDSS Overall score||Standard Deviation|Mean
2705739|NCT01201356|Secondary|Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score|"The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration.~If baseline EDSS score is <=5, improvement is indicated by an EDSS score change of <= -1, stable is indicated by an EDSS score change of > -1 and <= 0.5, deterioration is indicated by an EDSS score change of > 0.5; if baseline EDSS score is > 5, improvement is indicated by an EDSS score change of <= -0.5, stable is indicated by an EDSS score change of > -0.5 and <= 0, deterioration is indicated by an EDSS score change of > 0. Only descriptive analysis performed."|Month 3 to Month 6 Follow-up|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||Participants|||Count of Participants
2705740|NCT01201356|Secondary|Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod|Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of >=1 and <=5.5, and by 0.5 points for patients with an FDF baseline EDSS>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.|Month 12 to Month 156|Fingolimod full analysis set|||Participants|||Number
2705759|NCT01201317|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥30% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)|||Participants|||Number
2705741|NCT01201356|Secondary|Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod|"The annualized rate of brain volume change is an averaged annual percentage change in brain volume. ARBA was calculated as: ARBA = [(SIENA/100+1) ^ (365.25/#days)-1]*100 where SIENA=(Vk/V0-1)*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed."|Month 3 to Month 156|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||Ratio||Standard Deviation|Mean
2705742|NCT01201356|Secondary|Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod|Descriptive statistics on normalized brain volume at core baseline and percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.|Month 0 (Core Baseline) to End of Study (an average of Month 156)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||cc||Standard Deviation|Mean
2705743|NCT01201356|Secondary|Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume|T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.|Month 3 to End of Study (Study Completion Visit)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||mm^3||Standard Deviation|Mean
2705744|NCT01201356|Secondary|Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume|Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.|Month 3 to End of Study (Study Completion Visit)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||mm^3||Standard Deviation|Mean
2705745|NCT01201356|Secondary|Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod|Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.|Month 0 (Core Baseline) to End of Study (an average of Month 156)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||Annual number of T2 lesions per patient|||Number
2705746|NCT01201356|Secondary|Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod|"A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.~In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed."|Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||Participants|||Number
2705747|NCT01201356|Secondary|Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod|Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.|Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)|Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.|||Annual number of relapses per patient|||Number
2705748|NCT01201356|Primary|Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death|Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.|Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years|Safety Set|||Participants|||Count of Participants
2705749|NCT01201343|Secondary|Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24|Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)|Baseline, Months 1, 2, 3, 6, 12, and 24|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
2705750|NCT01201343|Secondary|Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
2705751|NCT01201343|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
2705752|NCT01201343|Secondary|Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
2705753|NCT01201343|Secondary|Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
2705754|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.|||units on a scale||Standard Deviation|Mean
2705755|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 18|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.|||units on a scale||Standard Deviation|Mean
2705756|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 12|Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
2705757|NCT01201317|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.|Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.|Baseline (Day 1) to Day 29 (Visit 7)|Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data|||Scores on a scale||Standard Deviation|Mean
2705758|NCT01201317|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)|||Participants|||Number
2705827|NCT01200589|Secondary|Number of Participants With Infusion Related Adverse Events Due to Study Drug|The number of participants with infusion related adverse events due to study drug was assessed.|36 weeks + 60 days|The safety set, comprised of all participants who received one dose of study drug, was analyzed.|||Participants|||Number
2705760|NCT01201317|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)|||Scores on a scale||Standard Deviation|Mean
2705761|NCT01201317|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)|||Scores on a scale||Standard Deviation|Mean
2705762|NCT01201265|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.|||mmHg||Standard Deviation|Mean
2705763|NCT01201265|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.|||millimetre of mercury (mmHg)||Standard Deviation|Mean
2705764|NCT01201265|Secondary|Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)|The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms.|Baseline, cycle 6|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. Here, n signifies the number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2705765|NCT01201265|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 28 days after termination of study treatment (approximately 1569 days)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
2705766|NCT01201265|Secondary|Overall Survival (OS)|Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||days||95% Confidence Interval|Median
2705767|NCT01201265|Secondary|Time to Progression (TTP)|Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression.|From the date of registration until the disease progression (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||days||95% Confidence Interval|Median
2705768|NCT01201265|Secondary|Percentage of Participants Achieving a Clinical Benefit Response (CBR)|Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2705769|NCT01201265|Secondary|Percentage of Participants Achieving an Overall Response|The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2705770|NCT01201265|Primary|Progression-free Survival (PFS)|Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From the date of registration until the disease progression or death (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment|||days||95% Confidence Interval|Median
2705771|NCT01201057|Secondary|Incidence of Genital Adverse Events Potentially Related to Treatment|Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.|For the duration of the study (up to Visit Day 21-30)|This outcome measure is adverse events, which are required to be reported separately under Adverse Events section.|||Participants|||Count of Participants
2705772|NCT01201057|Secondary|Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)|Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.|Day 9-30|The analysis population is the mITT.|||Participants|||Count of Participants
2705773|NCT01201057|Secondary|Number of Women With Nugent Cure as a Measure of Efficacy|Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.|Day 9-30|The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.|||Participants|||Count of Participants
2705774|NCT01201057|Secondary|Number of Women With Clinical Cure as a Measure of Efficacy|Number of women with clinical cure as determined by absence of BV by the Amsel's criteria|Day 9-12|The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.|||Participants|||Count of Participants
2705775|NCT01201057|Primary|Number of Women With Clinical Cure as a Measure of Efficacy|Number of women with clinical cure as determined by absence of BV by the Amsel's criteria|Day 21-30|The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.|||Participants|||Count of Participants
2705776|NCT01200992|Secondary|Comparison of Safety of EN3348 With Mitomycin C [Adverse Events (Other Than Serious Adverse Events) With Frequency Threshold of 5% or Greater].|Safety endpoint displayed includes adverse events (other than serious adverse events) with a frequency threshold of 5% or greater, for each treatment arm. No statistical comparisons have been performed between the 2 treatment arms.|Through study early termination, approximately 23 months from first subject enrolled.|Relevant safety data are presented in the Adverse Events and Serious Adverse Events Modules. Any clinically significant findings pertaining to other secondary outcomes such as vital signs, physical exams and laboratory test results would appear in these Modules as well. No statistical comparisons have been performed between the 2 treatment arms.|||participants|||Number
2705777|NCT01200992|Primary|Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.|Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.|1 year|The study was discontinued early. The number of subjects randomized at time of closure represented 18.7% of the planned enrollment of 450 subjects. Thus, the planned analysis as stated in the protocol was not performed. Only 2 subjects (5.1%) in the EN3348 arm and 4 subjects (8.9%) in the mitomycin C arm completed all planned doses.||||||
2705778|NCT01200875|Primary|Blood Growth Factor Concentrations||5 days following PRP injection||||IGF-1 fold-change from baseline @ 24h||95% Confidence Interval|Mean
2705779|NCT01200810|Secondary|Safety and Tolerability Assessed Using NCI CTCAE Version 4.0|Number of participants randomized to RO4929097 arm who experienced serious adverse events .|Up to 12 months||||participants|||Number
2705780|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Observation Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.||||||
2705781|NCT01200810|Secondary|Time to PSA Progression During the Observation Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.||||||
2705782|NCT01200810|Secondary|Time to PSA Progression During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug.||||||
2705783|NCT01200810|Secondary|Time to PSA Nadir During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug.||||||
2705784|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.||||||
2705785|NCT01200810|Secondary|Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.||||||
2705786|NCT01200810|Primary|Time to PSA Progression|Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.|Up to 12 months|Data were not collected as the protocol was terminated early due to lack of study drug. Only three patients progressed during randomization phase.||||||
2705787|NCT01200797|Primary|Time to Progression (TTP)|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to date of progression (assessed up to 12 months)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.|||days||95% Confidence Interval|Median
2705788|NCT01200797|Primary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details).|On‐study date to date of death from any cause (assessed up to 12 months)|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||daya||95% Confidence Interval|Median
2709332|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non-Q-wave)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705789|NCT01200797|Primary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of (assessed up to 12 months)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2705790|NCT01200797|Primary|Number of Patients With Each Worst-grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death.|On‐study date to 30 days following final dose of study|Total number of patients reported with any toxicity. Not all participants may have an adverse event, thus not every patient on-treatment may be accounted for in worst-grade toxicities.|||participants|||Number
2705791|NCT01200797|Primary|Overall Response (OR)|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. Confirmation of CR or PR is required to deem either one the best overall response.|On‐treatment date to date of disease progression (assessed up to 12 months)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is nonevaluable for best overall response|||participants|||Number
2705792|NCT01200758|Secondary|Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion|"All investigator physicians and nurses involved in this study were asked to complete question i.e. Which formulation of rituximab (SC or IV) do you think is more convenient? based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient."|After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of responses|||Number
2705793|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20|All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.|After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of responses|||Number
2705794|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab|Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)|"Safety Analysis Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
2705795|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab|Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)|"Safety Analysis Population: included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
2705796|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase|Depletion is defined as a CD19 value <80 cells/mm^3.|Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
2705828|NCT01200589|Secondary|Number of Participants With Infection Related Adverse Events|The number of participants with infection related adverse events was assessed.|200 weeks|The safety set, comprised of all participants who received one dose of study drug, was analyzed.|||Participants|||Number
2705797|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase|Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3).|Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
2705798|NCT01200758|Secondary|Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration||12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])|"Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||mcg/mL||Full Range|Median
2705799|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle|Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2705800|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle|Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months])|Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2705801|NCT01200758|Secondary|Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab|Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])|Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)|Stage 1 PK Evaluable Population. Here, number of participants analyzed = participants evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2705802|NCT01200758|Secondary|Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])|Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)|Stage I PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2705803|NCT01200758|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.|Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])|ITT population.|||days||95% Confidence Interval|Median
2705804|NCT01200758|Secondary|Percentage of Participants Who Died||Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])|ITT population.|||percentage of participants|||Number
2705805|NCT01200758|Secondary|Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL|Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT population.|||days||95% Confidence Interval|Median
2705806|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL|Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT population.|||percentage of participants|||Number
2705829|NCT01200589|Secondary|Number of Deaths|The number of deaths were assessed.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
2706007|NCT01199471|Secondary|Time to Loss of Consciousness of Patients Administered Anesthesia|The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).|Up to 10 minutes|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
2705807|NCT01200758|Secondary|Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL|PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT Population.|||days||95% Confidence Interval|Median
2705808|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death|Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT Population.|||percentage of participants|||Number
2705809|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)|ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2705810|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)|ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2705811|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2705812|NCT01200758|Secondary|Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage II ITT Population.|||percentage of participants||95% Confidence Interval|Number
2705830|NCT01200589|Secondary|Number of Participants With Overall Response (OR)|The overall response rate (ORR) was defined as the number of participants achieving a CR or partial response (PR). from start of randomization until disease progression, or the start of a new anti-cancer therapy. Disease response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML). Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation. Bone marrow examination to confirm a suspected complete response (CR) was performed within 8 weeks following the onset of a CT scan confirmed CR.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
2705813|NCT01200758|Secondary|Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage I ITT Population.|||percentage of participants||95% Confidence Interval|Number
2705814|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2705815|NCT01200758|Secondary|Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not.|||percentage of participants||95% Confidence Interval|Number
2705816|NCT01200758|Primary|Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)|Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage II ITT Population included all participants who were randomized in Stage II irrespective whether they received study drug or not.|||percentage of participants||95% Confidence Interval|Number
2705817|NCT01200758|Primary|Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab||Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)|Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2705818|NCT01200602|Secondary|Toxicity Profile|Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2705819|NCT01200602|Secondary|Weight Maintenance Over Time||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2705820|NCT01200602|Secondary|Caloric Intake||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2705821|NCT01200602|Secondary|BMI Trends||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2705822|NCT01200602|Primary|Proportion of Patients Who Maintain Weight or Experience Weight Gain|"A patient will be defined as success if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry."|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2705823|NCT01200589|Secondary|Pharmacokinetics||70 weeks|The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.||||||
2705824|NCT01200589|Secondary|Time to Next Treatment||200 weeks|The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.||||||
2705825|NCT01200589|Secondary|Duration of Response (DOR)||200 weeks|The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.||||||
2705826|NCT01200589|Secondary|Number of Participants With Myelosuppression Adverse Events|The number of participants with myelosuppression adverse events was assessed.|200 weeks|The safety set, comprised of all participants who received one dose of study drug, was analyzed.|||Participants|||Number
2705831|NCT01200589|Secondary|Number of Participants With Complete Response (CR)|Complete response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) and defined as follows: 1) complete disappearance of all detectable clinical evidence of disease (all target nodes regressing to <=1.5cm in the long axis and all non-target lesions being normal in size by imaging) and disease-related symptoms if present before therapy; 2) the spleen/liver, if considered enlarged due to lymphoma based on CT scan prior to therapy, would be normal and nodules should disappear; and 3) if bone marrow was involved before treatment, the infiltrate must clear on repeat bone marrow biopsy. Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
2705832|NCT01200589|Primary|Progression-free Survival (PFS) - Number of Participants With PFS Events|Disease response assessed by modified 2007 Revised Response Criteria for Malignant Lymphoma. Nodal disease, PD: 1)prev. normal node (<=1.5cm x <=1.0cm) that incr. to >2.0 x ≥1.5cm; 2)≥50% incr. from nadir product of perpendicular diameter (PPD) of any prev. involved node with long axis >1.5cm at baseline (BL) (must incr. by ≥0.5mm & to >2.0cm) OR ≥50% incr. from nadir in long axis of any prev. inv. node with long axis of >1.5cm at BL (long axis must incr. by ≥0.5mm & to >2.0cm); or 3)≥50% incr. from nadir in the sums of prod. of diameters (SPD) of target nodes & ≥1 node with long axis >1.5cm. Extranodal, PD 1)any new lesion >2.0 x ≥1.5cm not attributed to non-lymphoma causes; 2)≥50% incr. from nadir PPD of any targ. les. & >5mm incr. in either axis & les. must measure >1.5cm x ≥1.5cm OR ≥50% incr. from nadir in long axis of any targ. les. & >5mm incr. in either axis & les. must measure >1.5cm x ≥1.5cm; or 3)≥50% incr. from nadir in SPD of targ. nodes & ≥1 node with long axis >1.5cm.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
2705833|NCT01200524|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.|LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.|Baseline (Day 1) to Day 29 (Visit 7)|mITT analysis set including only those that had adequate NPSI data at baseline and Day 29|||Scores on a scale||Standard Deviation|Mean
2705834|NCT01200524|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set|||Participants|||Number
2705835|NCT01200524|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set|||Participants|||Number
2705836|NCT01200524|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28|||Scores on a scale||Standard Deviation|Mean
2705837|NCT01200524|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28|||Scores on a scale||Standard Deviation|Mean
2705838|NCT01200511|Secondary|Patient Reported Outcomes at Month 6|The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.|||units on a scale||Standard Deviation|Mean
2705839|NCT01200511|Primary|Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6|Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.|||percentage of participants|||Number
2705840|NCT01200511|Primary|Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6|VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.|||logMAR||Standard Deviation|Mean
2706454|NCT01196104|Secondary|Mild or Moderate Hypoglycemic Event Rate|"Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Nonsevere hypoglycemia is defined as a subject:~SMBG levels < 70 mg/dL AND/OR~Symptoms that are relieved by the self-administration of carbohydrates"|Baseline to Week 16|Safety Population|||Events / subject-month|||Number
2705841|NCT01200511|Primary|Uncorrected Visual Acuity Across a Range of Distances at Month 6|Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.|||logMAR||Standard Deviation|Mean
2705842|NCT01200498|Primary|Participants With an Objective Response|Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion & growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count & absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) & ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast|Baseline to 3 Cycles (84 days)||||Participants|||Number
2705843|NCT01200485|Primary|Number of Cycle 2 Participants Normalizing Uric Acid Levels (UAL) Within 24 Hours of Treatment|Number of participants with normalized UAL as determined by a uric acid blood test at either 24 hours. A uric acid blood test, also known as a serum uric acid measurement, determines how much uric acid is present in the blood where normal levels are 2.4-6.0 mg/dL (female) and 3.4-7.0 mg/dL (male).|Up to 24 hours of cycle 2 dose delivery|One participant in Arm A missed one UA level assessment.|||Participants|||Count of Participants
2705844|NCT01200485|Primary|Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome)|"Number of participants (incidence) of LTLS in the two arms, as defined by the Cairo-Bishop criteria , during cycle 2.~Cairo-Bishop criteria:~Uric acid x ≥ 476 μmol/l or 25% increase from baseline Potassium x ≥ 6·0 mmol/l or 25% increase from baseline Phosphorous x ≥ 2·1 mmol/l (children), x ≥1·45 mmol/l (adults) or 25% increase from baseline Calcium x ≤ 1·75 mmol/l or 25% decrease from baseline Laboratory tumour lysis syndrome (LTLS) is defined as either a 25% change or level above or below normal, as defined above, for any two or more serum values of uric acid, potassium, phosphate, and calcium within 3d before or 7d after the initiation of chemotherapy."|Up to two 3-week cycles, 6 weeks|All 46 participants treated in randomized cycle 2 of study were included in analysis.|||Participants|||Count of Participants
2705845|NCT01200433|Secondary|Number of Apneic Episodes.|The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.|during DBS surgery||||number of episodes||Inter-Quartile Range|Median
2705846|NCT01200433|Secondary|Number of Hypertensive Episodes|The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.|During DBS surgery||||number of episodes||Standard Deviation|Mean
2705847|NCT01200433|Secondary|Cerebral Perfusion Pressure||at the first peak during DBS surgery||||mmHg||Inter-Quartile Range|Median
2705848|NCT01200433|Secondary|Pulsatility Index|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.|at the first peak during DBS surgery||||units on a scale||Inter-Quartile Range|Median
2705849|NCT01200433|Secondary|Alertness/Sedation|Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)|at the first peak during DBS surgery||||units on a scale||Inter-Quartile Range|Median
2705850|NCT01200433|Secondary|Cerebral Blood Flow|The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.|after procedure, in post anesthesia care unit (PACU)|The cerebral flow at PACU was not planned as a primary outcome. The primary outcome was cerebral flow at the first peak of study drug. The data was collect for information purpose only. No test was done for cerebral blood flow at PACU.|||cm/sec||Standard Deviation|Mean
2705851|NCT01200433|Primary|Brain Oxygen|Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.|during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods||||% oxygenation||Inter-Quartile Range|Median
2705852|NCT01200433|Primary|Cerebral Blood Flow|Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.|For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.||||cm/sec||Inter-Quartile Range|Median
2705853|NCT01200394|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs)|Baseline up to Week 16 (follow-up)|Safety analysis set consists of all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2705880|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2705854|NCT01200394|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory test abnormalities: Hematology (hemoglobin [<0.8*lower limit of normal{LLN}], hematocrit [<0.8*LLN], red blood cells [<0.8*LLN], platelet [<0.5*LLN/>1.75*upper limit of normal{ULN}], white blood cells [<0.6*LLN/>1.5*ULN], lymphocytes [<0.8*LLN/>1.2*ULN], neutrophils [<0.8*LLN/>1.2*ULN], basophils [>1.2*ULN], eosinophils [>1.2*ULN], monocytes [>1.2*ULN]); Liver Function (total/direct/indirect bilirubin [>1.5*ULN], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase [>3.0*ULN]); Renal Function (blood urea nitrogen/ creatinine [>1.3*ULN], uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/>1.05*ULN], potassium, chloride, calcium, bicarbonate [<0.9*LLN/>1.1*ULN]); Clinical Chemistry (glucose [<0.6*LLN/>1.5*ULN], glycosylated hemoglobin [>1.3*ULN], Creatine Kinase [>2.0*ULN], Amylase, Lipase[>1.5*ULN]).|Baseline up to Week 16 (follow-up)|Safety analysis set consists of all participants who received at least 1 dose of study medication. Here 'N' (Overall Number of Participants Analyzed) signifies participants evaluable for this measure.|||Participants|||Count of Participants
2705855|NCT01200394|Other Pre-specified|Number of Participants With Increased Use of Diuretics||Baseline up to Week 16 (follow-up)|Safety analysis set consists of all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2705856|NCT01200394|Other Pre-specified|Number of Participants With Edema and Fluid Overload|Participants were assessed for signs of edema and fluid overload.|Week 0, 3, 6, 12, 16 (follow-up)|Safety analysis set consists of all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2705857|NCT01200394|Other Pre-specified|Number of Participants With Vital Signs Abnormalities|Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than [<] 90 mmHg and increase or decrease of greater than or equal to [>=] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (<50 mmHg and increase or decrease of >=20 mmHg compared to baseline value), supine pulse rate (>120 beats per minute [bpm] or <40 bpm), standing pulse rate (>140 bpm or <40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported.|Baseline up to Week 16 (follow-up)|Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||Participants|||Count of Participants
2705858|NCT01200394|Other Pre-specified|Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16|Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1).|Baseline, Week 12, 16 (follow-up)|Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2705859|NCT01200394|Secondary|Plasma Concentration Versus Time Summary of PF-00489791||Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6|"Pharmacokinetic analysis set included all randomized and treated participants with at least 1 measured PF-00489791 concentration. Here, Number analyzed signifies number of participants evaluable for specified categories. This outcome measure was planned not to be analyzed for Placebo reporting arm."|||microgram per millilitre (microgram/mL)||Standard Deviation|Mean
2705860|NCT01200394|Secondary|Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16|Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).|Baseline, Week 12, 16 (follow-up)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||mg/L||Standard Deviation|Mean
2705861|NCT01200394|Secondary|Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16|The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).|Baseline, Week 12, 16 (follow-up)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||milligram per liter (mg/L)||Standard Deviation|Mean
2705862|NCT01200394|Secondary|Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16|TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).|Baseline, Week 3, 6, 12, 16 (follow-up)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2705863|NCT01200394|Secondary|Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16|Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).|Baseline, Week 3, 6, 12, 16 (follow-up)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||micromole per liter (mcmol/L)||Standard Deviation|Mean
2705881|NCT01200368|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.|||percentage of participants||95% Confidence Interval|Number
2705864|NCT01200394|Secondary|Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16|Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.|Week 0, 3, 6, 12, 16 (follow-up)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement.|||millimeter of mercury (mmHg)||95% Confidence Interval|Least Squares Mean
2705865|NCT01200394|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16|The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).|Baseline, Week 3, 6, 12, 16 (follow-up)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||mL/min/1.73 m^2||Standard Deviation|Mean
2705866|NCT01200394|Secondary|Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16|UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.|Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||mg/mmol||Standard Deviation|Mean
2705867|NCT01200394|Secondary|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16|UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.|Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||mg/mmol||Standard Deviation|Mean
2705868|NCT01200394|Primary|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12|UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.|Baseline, Week 12 (Day 5, 6, 7)|Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, ‘Number analyzed’ = Participants evaluable at specified time points for each arm, respectively.|||mg/mmol||Standard Deviation|Mean
2705869|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
2705870|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
2705892|NCT01200355|Primary|Time to Failure|Clinical failure is defined as: 1) need for systemic antifungal therapy (AmBisome) for > 3 consecutive days for presumptive fungal infection, toxicity or intolerance of study medication or 2) death.|2 years|Analysis based on a modified intention-to-treat (mITT) approach, with the use of data from patients who underwent randomization and received 2 or more doses of prophylaxis. Trial designed w/ power to detect absolute differences of ~25% of prophylaxis failure in the two groups with ~ 80% power and a significance level of 5% using a two-tail test.|||Days||Inter-Quartile Range|Median
2705871|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
2705872|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
2705873|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2705874|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2705875|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2705876|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2705877|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.|||EU/mL||95% Confidence Interval|Geometric Mean
2705878|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.|||IU/mL||95% Confidence Interval|Geometric Mean
2705879|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
2705956|NCT01199822|Secondary|Terminal Elimination Half-Life (t1/2) of Olaratumab|t1/2 is the time it takes for the drug concentration in serum to decrease to half the value observed at the beginning of the time period.|Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate t1/2. Due to limited data and the relatively short duration of sample collection, t1/2 is not representative of the study population.|||days||Full Range|Geometric Mean
2705882|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2705883|NCT01200368|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.|||percentage of participants||95% Confidence Interval|Number
2705884|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series|Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2705885|NCT01200368|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2705886|NCT01200368|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2705887|NCT01200368|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2705888|NCT01200355|Secondary|To Compare Overall Survival Rates at 6 Weeks||6 weeks from randomization between the two treatment arms.||||Participants|||Count of Participants
2705889|NCT01200355|Secondary|Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.||2 years||||Participants|||Count of Participants
2705890|NCT01200355|Secondary|To Compare the Incidence of Possible, Probable or Proven Invasive Fungal Infections Between Patients Who Receive Posaconazole and Those Who Receive Micafungin During Treatment Phase||2 years||||Participants|||Count of Participants
2705891|NCT01200355|Secondary|To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.||2 years|Results reflect patients who discontinued prophylaxis for suspected IFI (invasive fungal infection)|||days||Inter-Quartile Range|Median
2707239|NCT01192282|Primary|HPV DNA and HIV Status|HPV DNA Positivity and HIV Status|18 Months|Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.|||participants|||Number
2705893|NCT01200342|Primary|Number of Participants With Response|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions.|||Participants|||Number
2705894|NCT01200342|Primary|Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. Due to inadequate enrollment of study participants, no statistical analyses were able to be performed.|||Percentage of Participants|||Number
2705895|NCT01200329|Secondary|Overall Survival (OS) of These Patients.|The overall survival is the length of time from the start of treatment (Auto SCT) for the cancer, that patients are diagnosed with are still alive until date of first documented progression or date of death from any cause. It is measured in months and assessed up to 84 months.|Beyond 100 days post transplant up to 84 months.||||Months||Full Range|Median
2705896|NCT01200329|Primary|Event-free Survival (EFS) of Patients|The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 30 days post transplant, and this rate will be compared with the 5% maximum rate. For EFS analysis, patients who experience the tumor relapse, disease progression, or death will be considered to be an event.|Enrollment up to 2 years post transplant|Patients with relapsed/refractory Hodgkin's disease (ie, extranodal relapse or within 1 year of frontline therapy).|||Participants|||Count of Participants
2705897|NCT01200290|Primary|Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up||Baseline through Weeks 24, 52 and 76|All enrolled participants who received at least 1 dose of study drug and had single antigen reactivity assessed at baseline, during treatment and during follow-up.|||Participants|||Count of Participants
2705898|NCT01200290|Secondary|Population Pharmacokinetics (PK): Constant Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|Baseline through Week 24|All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliters/hour (mL/h)||Standard Error|Mean
2705899|NCT01200290|Secondary|Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood|B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).|Baseline, Weeks1, 4, 8, 16, 24, 36 and 52|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.|||percent change in absolute counts||Standard Deviation|Mean
2705900|NCT01200290|Secondary|Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood|B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).|Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.|||relative percent of Lymphocytes||Standard Deviation|Mean
2705901|NCT01200290|Secondary|Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil|B cell population counts are: Total B cells [cluster designation (CD)19+], mature naïve B cells [CD19+CD27-immunoglobulin D (IgD)+CD10-], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).|Baseline, Weeks 1 and 24|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline tonsil B cell populations value and at least 1 non-missing post-baseline B cell populations value.|||relative percent of Lymphocytes||Standard Deviation|Mean
2709333|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non-Q-wave)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2705902|NCT01200290|Secondary|Change From Baseline in Serum Immunoglobulin Levels|Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels.|Baseline, Weeks 8, 16, 24, 36 and 52|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline Ig value and at least 1 non-missing post-baseline Ig value.|||grams/liter (g/L)||Standard Deviation|Mean
2705903|NCT01200290|Primary|Change From Baseline in Arcsine Transformed PRA Scores|The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population.|Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.|||units on a scale||Standard Deviation|Mean
2705904|NCT01200290|Primary|Change From Baseline in PRA|The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population.|Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.|||percentage of population||Standard Deviation|Mean
2705905|NCT01200238|Secondary|Grade 3-4 Treatment-Related Toxicity Rate|All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.|AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)). Thus, AEs on treatment were followed up to 31.7 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
2705906|NCT01200238|Secondary|Overall Survival (OS)|OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.|Survival follow-up occurred every 4 weeks long-term; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months).Thus, follow-up was up to 36.4m.|The analysis dataset is comprised of all enrolled participants.|||months||90% Confidence Interval|Median
2705907|NCT01200238|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not experience progression were censored at date of last disease evaluation.|Dz was evaluated every 8 weeks on treatment; Imaging was obtained as clinically indicated until off-study; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months). Thus, follow-up was up to 36.4m.|The analysis dataset is comprised of all enrolled participants.|||months||90% Confidence Interval|Median
2705908|NCT01200238|Secondary|Disease Control Rate (DCR)|DCR is defined as achieving stable disease (SD), partial response (P R) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. PR or better response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)].Thus, response on treatment was evaluated up to 31.7 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
2705909|NCT01200238|Secondary|Objective Response Rate (ORR)|ORR is defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)]. Thus, response on treatment was evaluated up to 31.7 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
2705910|NCT01200238|Primary|Expression of cMET|To estimate the proportion of patients with greater than 50% decrease in expression of HSP90 client protein c-MET 18-24 hours after administration of STA-9090|Estimated up to 24 hours after administration of STA-9090|There was a problem with the assay and therefore this endpoint was not measured.||||||
2705911|NCT01200238|Primary|4-month Progression Free Survival (PFS) Rate|4-month PFS rate was defined as the proportion of participants alive, absent progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) and on treatment at 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Relevant for this endpoint was status at 4 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
2705912|NCT01200160|Secondary|Overall Safety and Tolerability of Niaspan|Evaluate overall safety of Niaspan through evaluation of adverse events|every 4 weeks for 24 weeks|||||||
2705913|NCT01200160|Secondary|Frequency of Flushing Events|evaluate occurrence of such events over time|every 4 weeks for 24 weeks|||||||
2705914|NCT01200160|Secondary|Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values|Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score|every 4 to 8 weeks for 24 weeks|||||||
2705915|NCT01200160|Primary|Effectiveness of Niaspan|"Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.~Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:~percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables."|24 weeks regarding baseline visit (visit1)||||mg/dL||Standard Deviation|Mean
2705916|NCT01200069|Secondary|Incidence of Headache & Severity Headache After ECT Treatment #3|Subject self reported numerical rating of incidence and severity of post ECT headache after treatment #3, 0=no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9 very serious pain, 10=unbearable pain.|1 hour after treatment, 6 hours, 24 hours and 48 hours||||units on a scale||Full Range|Mean
2705917|NCT01200069|Secondary|Incidence and Severity of Headache After ECT Treatment 2|Subject self reported numerical rating of incidence and severity of post ECT headache 0=no pain, 2-4=moderate pain, 5-7= distressing severe pain, 8-9= very severe pain, 10=unbearable pain.|1 hour, 6 hour, 24 hour and 48 hours||||units on a scale||Full Range|Mean
2705918|NCT01200069|Secondary|Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1|Subject self reported numerical rating of incidence and severity of Post ECT pain score for headache at 1, 6, 24 and 48 hours post procedure. Pain Rating 0= no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9=intense very severe pain, 10=unbearable pain|1 hour, 6 hours, 24 hours & 48 hours following procedure||||units on a scale||Full Range|Mean
2705919|NCT01200069|Primary|Myalgia Reported After Treatment #3|Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities)|1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment||||units on a scale||Full Range|Median
2705920|NCT01200069|Primary|Myalgia Reported on Treatment Day 2|Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities)|1 hour, 6 hours, 24 hours & 48 hours following procedure||||units on a scale||Full Range|Median
2705921|NCT01200069|Primary|Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1|subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL|Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours|subjects report at one hour following treatment|||units on a scale||Full Range|Median
2705922|NCT01200030|Secondary|Forward Sitting Functional Reach Test|Sitting Functional Reach was used to assess the limits of stability in reaching activities. The sitting functional reach test measures how far forward, from a sitting position, a subject can bend forward to reach without losing his/her balance. A longer reaching distance indicated a better trunk control.|baseline, 6 weeks||||cm||Standard Deviation|Mean
2705923|NCT01200030|Primary|Trunk Impairment Scale|The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk.|baseline, 6 weeks||||units on a scale||Standard Deviation|Mean
2705924|NCT01199965|Primary|AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg*h/ml||Standard Deviation|Geometric Mean
2705925|NCT01199965|Primary|Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Geometric Mean
2706573|NCT01195779|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2705926|NCT01199952|Secondary|Reasons for Discontinuation of Contraception|"To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.~To describe the concerns that lead to discontinuation or method change.~To assess feasibility of conducting a follow-up telephone call in this population"|6 weeks after abortion procedure|number who responded to 6 week follow-up contact responses to outcome measures were not mutually exclusive, and therefore will not add up to the total number of participants who responded to the six week survey/contact.|||Participants|||Count of Participants
2705927|NCT01199952|Primary|Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion|To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.|6 weeks after abortion procedure|study sample is female only since study is birth control selected following surgical abortion|||Participants|||Count of Participants
2705928|NCT01199939|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48||Baseline (Day 1) and Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications|||cells/uL||Standard Deviation|Mean
2705929|NCT01199939|Secondary|Number of Participants With Virologic Failure|Virologic Failure is defined as participant who is a rebounder or a non-responder. Rebounder participant is defined as a participant who is still in the study at Week 12 and first achieves 2 consecutive virologic responses (<50 copies/mL) followed by 2 consecutive non-responses or a discontinued participant (any reason) for which the last observed time point shows a non-response. Non responder participant is defined as a participant who is still in the study at Week 12 and never achieves 2 consecutive responses.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications|||Participants|||Number
2705930|NCT01199939|Secondary|Time to Reach First Confirmed Virologic Response|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus - type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications|||Days||Standard Error|Mean
2705931|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 48||Baseline (Day 1) and Week 48|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 48|||log10 Copies/mL||Full Range|Median
2705932|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 42||Baseline (Day 1) and Week 42|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 42|||log10 Copies/mL||Full Range|Median
2705933|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 36||Baseline (Day 1) and Week 36|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 36|||log10 Copies/mL||Full Range|Median
2705934|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 30||Baseline (Day 1) and Week 30|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 30|||log10 Copies/mL||Full Range|Median
2705935|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 24||Baseline (Day 1) and Week 24|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 24|||log10 Copies/mL||Full Range|Median
2705936|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 20||Baseline (Day 1) and Week 20|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 20|||log10 Copies/mL||Full Range|Median
2705937|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 16||Baseline (Day 1) and Week 16|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 16|||log10 Copies/mL||Full Range|Median
2705938|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 12||Baseline (Day 1) and Week 12|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 12|||log10 Copies/mL||Full Range|Median
2705939|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 8||Baseline (Day 1) and Week 8|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 8|||log10 Copies/mL||Full Range|Median
2705940|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 4||Baseline (Day 1) and Week 4|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 4|||log10 Copies/mL||Full Range|Median
2705941|NCT01199939|Primary|Number of Participants With Confirmed Virologic Response (CVR) at Week 48|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus - type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Week 48|Intent-To-Treat Non-Virologic failure (VF) censored: Participants who took at least one dose of any of the study medications and did not withdraw for reasons other than VF or experienced VF prior to discontinuation. Participants with evaluable data at Week 48|||Participants|||Number
2705942|NCT01199926|Primary|Inflammation|The primary endpoint is the change in C reactive protein after the three month intervention|three months||||mg/L||Standard Deviation|Mean
2705943|NCT01199926|Primary|Glucose Tolerance|The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.|||mmol/L/120 min||Standard Deviation|Mean
2705944|NCT01199926|Primary|Muscle Function|The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.|||kilograms||Standard Deviation|Mean
2706623|NCT01195584|Secondary|Blood Loss|Loss of blood during surgical procedure in milliliters.|after surgery|analysis per protocol|||ml||Standard Deviation|Mean
2705945|NCT01199861|Secondary|Number of Participants With Adverse Events (AEs)|"Relationship to study drug was determined by the investigator (suspected/not suspected).~A serious AE is defined as an event which fulfills one of the following criteria:~is fatal or life-threatening;~results in persistent or significant disability/incapacity;~constitutes a congenital anomaly/birth defect;~requires inpatient hospitalization or prolongation of existing hospitalization;~is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above."|From first dose of study drug until 45 days after the last dose of study drug (130 days).|Safety set - all patients who received at least 1 dose of study drug.|||participants|||Number
2705946|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).|Full analysis set for whom data were available.|||ratio|||Number
2705947|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).|Full analysis set for whom data were available.|||ratio|||Number
2705948|NCT01199861|Secondary|Immune Response 6 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:~Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.~Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)|Full analysis set for whom data were available.|||percentage of participants|||Number
2705949|NCT01199861|Secondary|Immune Response 3 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:~Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.~Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)|Full analysis set for whom data were available.|||percentage of participants|||Number
2705950|NCT01199861|Secondary|Immune Response 6 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:~Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.~Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).|Full analysis set for whom data were available.|||percentage of participants|||Number
2705951|NCT01199861|Primary|Immune Response 3 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:~Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.~Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)|The full analysis set which includes all patients who were randomized and received at least 1 dose of study drug, and for whom data were available.|||percentage of participants|||Number
2705952|NCT01199822|Secondary|Number of Participants With Treatment Related AEs|Data presented are the number of participants who experienced a treatment related AE of any grade.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2705953|NCT01199822|Secondary|Number of Participants With Serum Anti-Olaratumab Antibody Assessment (Immunogenicity)|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|First dose to study completion up to 5.6 months|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.|||participants|||Number
2705954|NCT01199822|Secondary|Volume of Distribution at Steady State (Vss)||Cycle 2: Pre-dose and up to 336 hours post-dose|Zero participants were analyzed because of insufficient amount of samples collected.||||||
2705955|NCT01199822|Secondary|Clearance of Olaratumab at Steady State (CLss)|CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.|Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate CLss. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to limited data, CLss is not representative of the study population.|||milliliters/hour/kilogram (mL/h/kg)||Geometric Coefficient of Variation|Geometric Mean
2706624|NCT01195584|Secondary|Operation Duration|Duration of the operation in minutes.|after surgery|analysis per protocol|||Minutes||Standard Deviation|Mean
2705957|NCT01199822|Secondary|Area Under the Concentration of Olaratumab Versus Time Curve During One Dosing Interval (AUCτ) Following Multiple Doses||Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate AUCτ. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to the limited data, AUCτ is not representative of the study population.|||micrograms*hours/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2705958|NCT01199822|Primary|Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses||Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had pharmacokinetic (PK) data available to calculate Cmax. Due to the limited data, Cmax is not representative of the study population.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2705959|NCT01199822|Primary|Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1|A DLT is defined as 1 of the following events, if considered by the investigator to be definitely, probably, or possibly related to olaratumab: NCI-CTCAE v4.02 Grade 4 neutropenia lasting >7 days; NCI-CTCAE v4.02 Grade ≥3 thrombocytopenia with signs of bleeding or requiring platelet transfusions; NCI-CTCAE v4.02 Grade ≥3 neutropenia associated with fever; NCI-CTCAE v4.02 Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality; NCI-CTCAE v4.02 Grade ≥3 skin toxicity despite best preemptive and supportive care; and/or NCI-CTCAE v4.02 Grade ≥3 diarrhea, nausea, or vomiting despite best preemptive and supportive care.|First dose through Cycle 1 (6 weeks/cycle)|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2705960|NCT01199822|Primary|Number of Participants With SAEs|A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2705961|NCT01199822|Primary|Number of Participants With Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.02. A summary of serious adverse events (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2705962|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications|Concomitant medications are defined as drugs used during the administration of Relenza.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705963|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705964|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories|Participants with only hypertension were excluded from the cardiocirculatory disease category. Participants in high-risk categories are at risk for the aggravation of both infection and symptoms.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705965|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors|Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705966|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications|A complication is defined as asthma.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705967|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza|The dose given for treatment of influenza is 10 mg twice daily for 5days. Prophylaxis is defined as a measure taken for the prevention of a disease or condition. The prophylactic dose of Relenza is 10 mg once daily for 10 days.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705968|NCT01199744|Secondary|Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705969|NCT01199744|Secondary|Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705988|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)~SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.|||SBIs per subject year|Participants||Number
2705970|NCT01199744|Secondary|Number of Participants With Any Serious Adverse Drug Reaction (ADR)|"A serious ADR is defined as a serious adverse drug event (ADE) that a physician has determined to be related to the use of Relenza. Serious ADE: death caused by an ADR; an event that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in severe symptoms requiring treatment so that symptoms do not lead to previously mentioned outcomes, and a congenital anomaly/birth defect. For a complete list of all serious ADRs recorded during the study, see Serious Adverse Events section."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705971|NCT01199744|Primary|Number of Participants With Any Adverse Drug Reaction|"An adverse drug reaction is defined as a drug adverse event that a physician has determined to be related to the use of Relenza. A drug adverse event is defined as any unfavorable or unintended sign (including laboratory test abnormalities), symptom, or disease that occurs when a drug is administered, regardless of the relationship to the drug. For a complete list of all adverse drug reactions recorded during the study, see the section entitled Other (Non-serious) Adverse Events."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
2705972|NCT01199731|Secondary|Number of Participants With Electrocardiograph (ECG) With Values of Potential Critical Concern (PCI)|Number of participants with ECG of PCI above 480 has been presented. ECG was be performed twice on Day 1 at least 5 minutes apart and following 5 minutes of rest in a semi supine position at ∼1 hour prior to first dose. ECG evaluations at other visits was obtained after dosing, preferably at 2 hours post dosing. An ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals was used.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
2705973|NCT01199731|Secondary|Number of Participants Who Discontinued Treatment Due to AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
2705974|NCT01199731|Secondary|Change From Baseline in CD4+ Cell Counts After Switch of GSK2248761|CD4 is a receptor for the HIV virus. Most of the damage to an AIDS patient's immune system is done by the virus' destruction of CD4+ lymphocytes. Change from Baseline was calculated as (observed value - Baseline value). Baseline was Day 1 value.|Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and Follow-up Week 4, 8, 12|ITT-E. Only those participants available at the specified time points were analyzed.|||Cells/mm^3||Standard Deviation|Mean
2705975|NCT01199731|Secondary|Change From Baseline in CD4+ Cell Counts Prior to Switch of GSK2248761|CD4 is a receptor for the HIV virus. Most of the damage to an AIDS patient's immune system is done by the virus' destruction of CD4+ lymphocytes. Change from Baseline was calculated as (observed value - Baseline value). Baseline was Day 1 value.|Baseline (Day 1) and Week 2, 4, 8, 12 and 16|ITT-E. Only those participants available at the specified time points were analyzed.|||Cells/mm^3||Standard Deviation|Mean
2705976|NCT01199731|Secondary|Absolute Values of CD4+ Cell Counts After Switch of GSK2248761|CD4 is a receptor for the HIV virus. Most of the damage to an AIDS participant's immune system was done by the virus' destruction of CD4+ lymphocytes. Absolute values of CD4+ cell counts after Switch of GSK2248761 has been presented.|Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and Follow-up Week 4, 8, 12|ITT-E. Only those participants with data available at the specified time points were analyzed.|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2705977|NCT01199731|Secondary|Number of Participants Who Experienced Disease Progression (HIV-associated Conditions, AIDS and Death)|Clinical DP was defined as progression from Baseline HIV disease status:Category A at Baseline to Centers for Disease Control and Prevention(CDC) category B event, category A at Baseline to CDC category C event, category B at Baseline to CDC category C event, category C at Baseline to new CDC category C event or category A, B or C at Baseline to death. Category A consisted of one or more of the conditions like asymptomatic HIV infection, persistent generalized lymphadenopathy and acute (primary) HIV infection with accompanying illness in an adolescent or adult(>13 years) with documented HIV infection. Category B consisted like Bacillary angiomatosis, Candidiasis, oropharyngeal (thrush), Candidiasis, vulvovaginal; persistent, frequent, oral, Herpes zoster etc. Category C included clinical conditions listed like Candidiasis of bronchi, trachea, or lungs, Candidiasis, esophageal, Cervical cancer, Coccidioidomycosis, disseminated or extrapulmonary etc in AIDS surveillance case definition.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|ITT-E population.|||Participants|||Count of Participants
2705978|NCT01199731|Secondary|Change From Baseline in Plasma HIV-1 RNA After Switch of GSK2248761|A switch was defined as any ART substitution or addition in the participant's ART regimen. Any ART switch permitted per protocol that was determined necessary and documented prior to the first on-treatment visit where HIV-1 RNA was assessed could occur without penalty. However, any participants with an ART switch not permitted per protocol or ART switch permitted per protocol with a viral load >=50 copies/mL at the time of the decision to switch was made was counted as a non-responder from that point onward for all assessment windows without a viral load measurement collected prior to the switch. Change from Baseline was calculated as (observed value - Baseline value ). Baseline was Day 1.|Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and follow-up Week 4, 8, 12|ITT-E. Only those participants available at the specified time points were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2705989|NCT01199705|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks||||Days||Full Range|Median
2705979|NCT01199731|Secondary|Change From Baseline in Plasma HIV-1 RNA Prior to Switch of GSK2248761|A switch was defined as any ART substitution or addition in the participant's ART regimen. Any ART switch permitted per protocol that was determined necessary and documented prior to the first on-treatment visit where HIV-1 RNA was assessed could occur without penalty. However, any participants with an ART switch not permitted per protocol or ART switch permitted per protocol with a viral load >=50 copies/mL at the time of the decision to switch was made was counted as a non-responder from that point onward for all assessment windows without a viral load measurement collected prior to the switch. Change from Baseline was calculated as (observed value - Baseline value). Baseline was Day 1. The unit is log10 copies per milliliter (log10 copies/mL).|Baseline (Day 1) and Week 2, 4, 8, 12 and 16|ITT-E population. Only those participants available at the specified time points were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2705980|NCT01199731|Secondary|Number of Participants With Abnormal Hematology Laboratory Data With Grade 3 or 4 TE Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of IP). The hematology parameters included hemoglobin, total neutrophils, and white blood cells (WBC) count. Categories with values has been presented. Grade 3=severe and Grade 4=potentially life threatening. No toxicity-related dose reductions of IP was allowed. IP and background ART was restarted as soon as medically appropriate; in general, this was no longer than 14] days after discontinuation (unless Grade 3 or 4 toxicities persisted).|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
2705981|NCT01199731|Secondary|Number of Participants With Abnormal Clinical Chemistry Laboratory Data With Grade 3 or 4 Treatment-Emergent (TE) Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of IP). Division of acquired immunodeficiency syndrome (AIDS) toxicity scale for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0 was used for grading i.e. Grade 3=severe and Grade 4=potentially life threatening. Categories with values have been presented. No toxicity-related dose reductions of IP was allowed. IP and background antiretroviral therapy (ART) was restarted as soon as medically appropriate; in general, this was no longer than 14] days after discontinuation (unless Grade 3 or 4 toxicities persisted).|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
2705982|NCT01199731|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population consisted of all randomized participants who were exposed to IPs with the exception of any participant with documented evidence of not having consumed any amount of IP.|||Participants|||Count of Participants
2705983|NCT01199731|Primary|Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies Per Milliliter (/mL) at Week 16|Plasma for quantitative HIV-1 RNA was collected. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 16 has been presented. A 2 ml plasma was assayed with the real-time NucliSens EasyQ HIV-1 assay (bioMerieux) capable of quantifying as low as 2.5 c/mL by using three modifications to the standard assay: 15 microliters (µl) of extracted eluate, 20 µl of primer, and 5 µl of 2X enzyme in place of standard kit volumes. The validated assay incorporated molecular beacons for detection.|At Week 16|Intent-to-Treat-Exposed (ITT-E) consisted of all randomized participants who received at least one dose of investigational product (IP). Only those participants with data available at the indicated time point were analyzed.|||Percentage of participants|||Number
2705984|NCT01199705|Secondary|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.~Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 36 weeks|The SDS comprised all subjects treated with the study drug.|||AEs per infusion|Participants||Number
2705985|NCT01199705|Secondary|Rate of All Adverse Events by Relatedness and Seriousness|The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 36 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.|||AEs per infusion|Participants||Number
2705986|NCT01199705|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks||||Days||Full Range|Median
2705987|NCT01199705|Secondary|Number of Days of Hospitalization Due to Infections by Study Period|Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks||||Days||Full Range|Median
2706006|NCT01199471|Secondary|Time to Intubation of Patients|The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.|Up to 10 minutes|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
2705990|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)~SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.|||SBIs per subject year|Participants||Number
2705991|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)~SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.|||Infections per subject year|Participants||Number
2705992|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)~SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.|||Infections per subject year|Participants||Number
2705993|NCT01199705|Secondary|Number of Infection Episodes (Serious and Non-serious) by Study Period|"Number of infection episodes (serious and non-serious) presented by study period:~IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).~SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.~SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy."|Up to 36 weeks||||Number of infection episodes|||Number
2705994|NCT01199705|Primary|IgG Trough Level|Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.|During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.|||Ratio of Geometric Means||90% Confidence Interval|Number
2705995|NCT01199601|Secondary|Completion of 9 Month Measles-mumps-rubella Vaccination on Time.|Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months||||participants|||Number
2705996|NCT01199601|Secondary|Correct Breastfeeding Practices to 1 Year|Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months||||participants|||Number
2705997|NCT01199601|Primary|Utilization of Postpartum Contraception|Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.|12 months|Participants included in analysis were those completing the 6 and 12 month follow-up visits.|||participants|||Number
2705998|NCT01199575|Secondary|Treatment Free Survival.||2 years|||||||
2705999|NCT01199575|Secondary|Overall Survival||4 years|||||||
2706000|NCT01199575|Secondary|Conversion of MRD-positive Complete Response or Partial Response (PR) to a MRD-negative Complete Response (CR) or Complete Response (CR) Respectively Following an Additional 6 Cycles of Revlimid Consolidation||13 cycles|||||||
2706001|NCT01199575|Secondary|Progression Free Survival.||2 years|||||||
2706002|NCT01199575|Secondary|Adverse Events to Study Treatment||one year||||Participants|||Count of Participants
2706003|NCT01199575|Primary|Overall Response Rate (ORR)||nine months||||Participants|||Count of Participants
2706004|NCT01199471|Secondary|Time to Extubation of Patients|The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.|Every minute after cessation of anesthesia until the patient was extubated|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
2706005|NCT01199471|Secondary|Time to Eye Opening of Patients|Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.|Every minute after cessation of anesthesia until the patient opened his/her eyes|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
2709334|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non-Q-wave)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2706008|NCT01199471|Primary|Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2706009|NCT01199471|Primary|Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.|||units on a scale||Standard Deviation|Mean
2706010|NCT01199263|Secondary|Tumor Response by CA125|Percentage of participants with Complete and Partial Tumor Response by CA125.|Before every cycle, approximately 4.5 years.|All enrolled patients.|||percentage of participants||95% Confidence Interval|Number
2706011|NCT01199263|Secondary|Median Overall Survival (OS) by Treatment Group|Time from patient randomization to death or date last seen.|After patient stops protocol therapy, she is followed quarterly for 2 years, semi-annually for 3 more years, approximately 4.5 years.|Enrolled patients.|||Months||95% Confidence Interval|Median
2706012|NCT01199263|Secondary|Percentage of Participants withTumor Response by RECIST|Participants with Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|approximately 4.5 years|All enrolled patients|||percentage of participants||95% Confidence Interval|Number
2706013|NCT01199263|Primary|Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0|The frequency and severity of Grade 3 and above toxicities are tabulated.|approximately 4.5 years|Eligible and treated participants|||Participants|||Count of Participants
2706014|NCT01199263|Primary|Progression-free Survival (PFS)|Time from patient entry until progression, death, or date last seen. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Approximately 4.5 years.|Enrolled patients|||Months||95% Confidence Interval|Median
2706015|NCT01199237|Secondary|Time From Anesthetic Discontinuation to First Ability to Swallow|At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.|up to 60 minutes after T1||||Seconds||Full Range|Mean
2706016|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|60 minutes after T1|Only patients able to respond at time of assessment|||units on a scale||Full Range|Mean
2706017|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|30 minutes after T1|Only participants able to respond at time of assessment|||units on a scale||Full Range|Mean
2706018|NCT01199237|Secondary|Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)|"At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands open your eyes and squeeze my hand were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1."|Up to 1 hour post-operative||||seconds||Full Range|Mean
2706019|NCT01199237|Primary|Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.|The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.|At 2 minutes after response to command (T1).|Only participants judged by the clinician as able to take the test (n=57)|||participants|||Number
2706020|NCT01199146|Secondary|Proportion of Patients With PSA Decline of > 50%||12 weeks from beginning of therapy||||Participants|||Count of Participants
2706021|NCT01199146|Secondary|Time To Progression (TTP)||beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria||||weeks||Full Range|Median
2706022|NCT01199146|Primary|Preliminary Evidence of Efficacy of Abiraterone Acetate|number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment|12 weeks from beginning of abiraterone treatment||||Participants|||Count of Participants
2706023|NCT01199042|Secondary|Average Therapy Pressure Values|"To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.~This analysis compares the average pressure support of the first week compared to the average pressure support to the final week."|3 months|26 participants completed the 3-month home follow-up.|||cm/H2O||Standard Deviation|Mean
2706024|NCT01199042|Secondary|Breathing Event Indexes|"To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.~Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment."|from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment|26 participants completed the 3-month home follow-up.|||Apnea-Hypopnea events per hour||Standard Deviation|Mean
2706625|NCT01195584|Primary|Postoperative Complications in the BMI Groups During Post Operative Hospitalization.|Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.|at hospital discharge|Analysis per protocol|||Events during hospitalization|||Number
2706025|NCT01199042|Secondary|Epworth Sleepiness Scale|"To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24.~Interpretation:~Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention.~Score 16-24: Excessive sleepiness and patient should consider seeking medical attention~A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness."|3 months|26 participants completed the 3-month home follow-up.|||units on a scale||Standard Deviation|Mean
2706026|NCT01199042|Primary|Apnea/Hypopnea Index (AHI)|To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.|During a single night of polysomnography lasting up to 8 hours.||||Apnea-Hypopnea events per hour||Standard Deviation|Mean
2706027|NCT01199016|Other Pre-specified|Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Healthy Participants|Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.|Baseline up to Month 36|NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.|||percentage of NP/OP samples|NP/OP Samples||Number
2706028|NCT01199016|Other Pre-specified|Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)|MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.|Baseline up to Month 36|MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.|||percentage of MEF samples|MEF Samples||Number
2706029|NCT01199016|Other Pre-specified|Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants|Total percentage of NP/OP samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.|Baseline up to Month 36|NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.|||percentage of NP/OP samples|NP/OP Samples||Number
2706030|NCT01199016|Primary|Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)|MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.|Baseline up to Month 36|MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.|||percentage of MEF samples|MEF Samples||Number
2706031|NCT01198977|Other Pre-specified|Physical Activity (Behavioral Target)|First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.|||units on a scale||Standard Error|Mean
2706032|NCT01198977|Secondary|Depression|"Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).~Total Score for 9 items = 27."|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.|||units on a scale||Standard Error|Mean
2706033|NCT01198977|Primary|Fatigue|Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.|||units on a scale||Standard Error|Mean
2706034|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Function|"left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)||||centimeters/second||Standard Deviation|Mean
2706075|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 15|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706035|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)|"Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined|||percentage of blood pumped out||Standard Deviation|Mean
2706036|NCT01198873|Secondary|Changes From Baseline in Left Atrial Dimension|"Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined|||centimeters||Standard Deviation|Mean
2706037|NCT01198873|Secondary|Changes From Baseline in Left Atrial Function|"left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined|||mililiters||Standard Deviation|Mean
2706038|NCT01198873|Primary|Change From Baseline in Left Atrial Volume Index (LAVi)|"Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|"The analysis included all randomized and treated participants with at least one post-baseline echocardiographic assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).~The quality of the post-baseline echocardiography was inadequate for determining LAVi in one participant."|||mililiters/m2||Standard Deviation|Mean
2706039|NCT01198795|Primary|Patients With Any Treatment Emergent Adverse Events (TEAEs)|The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,|From Baseline (Week 0) to Week 26||||participants|||Number
2706040|NCT01198769|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (from Dose 1 at Day 0 up to Month 4)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2706041|NCT01198769|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) follow-up period after vaccination|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2706042|NCT01198769|Secondary|Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.|"RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.~GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA)."|From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2706043|NCT01198769|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.|During the 8-day (Days 0-7) post-vaccination period|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2706044|NCT01198769|Secondary|Serum Anti-rotavirus IgA Antibody Concentrations.|Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.|||U/mL||95% Confidence Interval|Geometric Mean
2706045|NCT01198769|Primary|Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.|||Subjects|||Number
2706073|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 15|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706046|NCT01198756|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2706047|NCT01198756|Secondary|Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2706048|NCT01198756|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination|"Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination."|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2706049|NCT01198756|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.|During the 28-day follow-up period (Day 0-27) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2706050|NCT01198756|Secondary|Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination|Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Days||Inter-Quartile Range|Median
2706051|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Days||Inter-Quartile Range|Median
2706052|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Days||Inter-Quartile Range|Median
2706053|NCT01198756|Secondary|Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Participants|||Count of Participants
2706054|NCT01198756|Secondary|Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Participants|||Count of Participants
2706104|NCT01198327|Primary|Incidence of Serious Adverse Events.|Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.|24 mos||||number of serious adverse events|||Number
2706055|NCT01198756|Secondary|Number of Days With Solicited Local Symptoms After Vaccination|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Inter-Quartile Range|Median
2706056|NCT01198756|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Participants|||Count of Participants
2706057|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||fold change||95% Confidence Interval|Geometric Mean
2706058|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706059|NCT01198756|Secondary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||Participants|||Count of Participants
2706060|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2706061|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||fold change||95% Confidence Interval|Geometric Mean
2706074|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 15|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706062|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706063|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2706064|NCT01198756|Primary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||Participants|||Count of Participants
2706065|NCT01198756|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2706066|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|Patient satisfaction will be assessed 6 weeks later at their post-op visit||||participants|||Number
2706067|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|This will be assessed 3 day after the patient's C-section before they are discharged from the hospital||||participants|||Number
2706068|NCT01198691|Primary|Post Operative Pain (3 Days Post-op)|Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year||||units on a scale||Standard Deviation|Mean
2706069|NCT01198691|Primary|Post Operative Pain|Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year||||units on a scale||Standard Error|Mean
2706070|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 43|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706071|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 43|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706072|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 43|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2709335|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non-Q-wave)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2706076|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 1|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706077|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 1|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706078|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1|"Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.)"|Day 1|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
2706079|NCT01198587|Secondary|Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.|Kappa inter-rater reliability measurement was done to analyze the agreement between the phone call data with parents reporting the number of episodes of diarrhea per day were compared to the written symptom charts where parents recorded the number of episodes of diarrhea per day. The inter-rater reliability ranges from 0 to 1 with scores of 0-0.2 = poor agreement, 0.2-0.4 = fair agreement, 0.4-0.6 = moderate agreement, 0.6-0.8 = good agreement and 0.8-1 = very good agreement|agreement over the 14 day follow up period|All patients enrolled in the study|||kappa statistic|||Number
2706080|NCT01198587|Secondary|Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents||over the 14 day symptom monitoring period||||Hours||Standard Deviation|Mean
2706081|NCT01198587|Primary|Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.|Patients symptoms will be assessed to identify the duration of diarrhea between zinc and placebo groups before it becomes chronic diarrhea which by definition lasts longer than 14 days. Outcome of all patients in study will be assessed at study conclusion.|14 days|The study failed to enroll sufficient inpatients due to the low hospitalization rate in the US for children who are otherwise healthy with diarrhea All patients were analyzed separately by arm and then again together for overall severity of diarrhea|||Hours||Standard Deviation|Mean
2706082|NCT01198574|Primary|Status of Cellular Iron Deficiency|Cellular Iron deficiency status is also measured by serum transferrin receptor|at week 0, week 6 and week12|Per Protocol analysis|||mg/L||Standard Deviation|Geometric Mean
2706083|NCT01198574|Primary|Status of Tissue Iron Store|Tissue iron store was measured by serum ferritin|at week 0, week 6 and week12|Per Protocol analysis|||µg/L||Standard Deviation|Geometric Mean
2706084|NCT01198574|Primary|Haemoglobin Level|Haemoglobin level (g/L) measured by cyanmethaemoglobin method|at week 0, week 6 and week12|Per Protocol|||g/L||Standard Deviation|Mean
2706085|NCT01198548|Secondary|PFS of Patients Receiving Study Treatment|"The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method.~3 Year Survival Rate"|Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2706086|NCT01198548|Secondary|OS of Patients Receiving Study Treatment|The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.|Up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2706087|NCT01198548|Secondary|Toxicity Rates as Assessed by NCI CTCAE Version 4||Up to 30 days post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2706088|NCT01198548|Secondary|RR of Patients Receiving Study Treatment||Up to 3 years|Trial terminated early. Too few patients to analyze.||||||
2706089|NCT01198548|Primary|Rate of Sufficient Cholecalciferol||By week 16|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2706090|NCT01198548|Primary|Median PFS|The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.|Up to 12 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2706091|NCT01198509|Secondary|Mean Units Change in DAS28 From Baseline to 6 Months|"DAS28 (disease activity score with 28 joint count). Possible score range: 0 to 10. This is a composite index calculated from 4 measures: two from a physician (28 tender joint count, 28 swollen joint count), one from the patient (patient global estimate of disease activity), and one laboratory biomarker (erythrocyte sedimentation rate or ESR). A score of 0 represents best possible health status (no apparent disease activity) and 10 represents worst possible.~The outcome is reported as mean change in DAS28 score from baseline to 6 months. The mean changes reported are negative values for downward change in score (i.e., improvement in health status)."|6 months|Please note that only the first 3 groups (RA doxycycline, RA vancomycin, and RA randomized to no treatment) were analyzed for change from baseline to six months (outcomes). Groups 4, 5 and 6 (RA cross-sectional, Psoriatic Arthritis, and Healthy Volunteers) were analyzed for baseline measures only in a cross-sectional comparison.|||units on a scale||Full Range|Mean
2706105|NCT01198275|Primary|Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)|Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.|one year||||partecipants|||Number
2706106|NCT01198275|Secondary|The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence|The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.|1, 3 and 6 months||2011-07-31|07/2011||||
2706092|NCT01198509|Primary|Alteration of Microbiota, Alteration of T Cell Function/Activation|"Oral and intestinal microbiota, and T cell function and activation, will be assessed at baseline, and at 1, 2, 3, 4 and 5 months after baseline, to determine whether changes are associated with vancomycin treatment versus doxycycline treatment versus no treatment.~Results are reported as number of participants who experienced changes in oral/intestinal microbiota, T cell function/activation.~Methods/criteria to assess change in microbiota: change in relative abundance of microorganisms at genus and species level (as assessed high-throughput 16S rDNA sequencing).~Methods/criteria to assess change in T cell function/activation: change in percentage of inhibition of regulatory T cells as measured by interferon gamma levels in in-vitro assays."|6 months|Primary outcome only evaluated in first three groups of RA patients: 4 randomized to treatment with doxycycline; 10 randomized to treatment with vancomycin; 19 randomized to no treatment.|||participants|||Number
2706093|NCT01198470|Primary|Number of Participants Determined to Have a Normal Neurological Status|"Neurological status was assessed using a neurological status scale, which is based on four types of measurement parameters: motor, sensory, reflexes, and straight leg raise. The method for summarizing neurological status is described below. Each parameter (i.e. motor, sensory, reflexes, straight leg raise) is coded as follows:~Motor 0 Total Paralysis~Palpable or Visible Contraction~Active Movement, Gravity Eliminated~Active Movement, Against Gravity~Active Movement, Against Some Resistance~Active Movement, Against Full Resistance~Sensory 0 Absent~Impaired~Normal~Reflexes 0 Absent or Trace~Hyper-reflexive~Normal or hypo-reflexive~Straight Leg Raise 0 0° - 70° (Abnormal)~1 > 70°-90° (Normal)~If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status."|24 months||||Participants|||Count of Participants
2706094|NCT01198470|Primary|Number of Participants With Major Complications Defined as Major Vessel Injury or Neurological Damage|Major vessel injury is defined as injury of the aorta or vena cava or other major vessels (e.g. iliac arteries, superior rectal artery, iliac veins, and their branches), caused by the surgery or device, resulting in significant blood loss or requiring additional surgery to correct. Neurological damage is defined as damage to the spinal cord or a nerve root caused by the surgery or device, resulting in neurologic deficit that persists for more than 3 months and is without improvement, is progressive, or involves motor loss. Major complications are reported on adverse event case report forms.|24 months||||Participants|||Count of Participants
2706095|NCT01198470|Primary|Number of Participants With No Device Failures|Any device requiring surgical revision, reoperation, removal or supplemental fixation will be considered a device failure|24 months||||Participants|||Count of Participants
2706096|NCT01198470|Primary|Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline|The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|24 months||||Participants|||Count of Participants
2706097|NCT01198366|Secondary|Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination|To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on >= 0.35IU/mL was considered positive for this study.|up to 24 months post vaccination|Subjects who received at least one vaccination and had results at baseline and end of study.|||% converting from QFT neg to pos|||Number
2706098|NCT01198366|Secondary|Antigen-specific Antibody Response - Mean Optical Density (Mean OD)|To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).|28 day post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4).~Assays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized."|||Optical Density||95% Confidence Interval|Median
2706099|NCT01198366|Secondary|Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay|To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.|28 days post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3).~Group 5: Subjects who received all three study vaccinations as randomized."|||SFU/10^6 PBMC||95% Confidence Interval|Median
2706100|NCT01198366|Secondary|Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects|To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.|28 days post last vaccination|Groups 1–4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.|||percentage of Tcell response||95% Confidence Interval|Median
2706101|NCT01198366|Primary|Adverse Events Collected Per Subject|Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile|Up to 24 months post vaccination|Subjects who received at least one vaccination.|||percentage of subjects with an AE|||Number
2706102|NCT01198327|Secondary|Mean Change in Retinal Thickness|Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).|24 mos from study baseline||||microns||Standard Deviation|Mean
2706103|NCT01198327|Secondary|Mean Changes in Visual Acuity|Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.|24 mos from study baseline||||ETDRS letters||Standard Deviation|Mean
2706107|NCT01198158|Secondary|Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.|Up to 30 days after completion of study treatment|All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.|||Participants|||Count of Participants
2706108|NCT01198158|Secondary|Objective Response Rate (CR + PR)|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|Up to 5.5 years||||percentage of participants||95% Confidence Interval|Number
2706109|NCT01198158|Secondary|Progression-free Survival (PFS)|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|The time from randomization to disease progression or death from any cause, assessed up to 5.5 years||||months||95% Confidence Interval|Median
2706110|NCT01198158|Primary|Overall Survival (OS)|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|The time from date of randomization to date of death due to any cause, assessed up to 5.5 years||||months||95% Confidence Interval|Median
2706111|NCT01198145|Secondary|Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue|For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.|Up to 6 weeks post radiotherapy|All completed QOL questionnaires were included in the analysis. Questionnaires used were completed during the first week during RT and 6 weeks after RT. From Arm I, 41 patients completed questionnaires, 39 during and 26 after RT. For Arm II, 42 patients completed the questions, 40 during and 29 after RT.|||percentage of participants|||Number
2706112|NCT01198145|Secondary|Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.|The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.|Up to 24 months post radiotherapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations.|||percentage of participants|||Number
2706113|NCT01198145|Secondary|"Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire"|"Questions that were used in this analysis:~2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?"|Up to 6 weeks post radiation therapy|All patients that completed the questionnaire were included in the analysis. Questionnaires used were completed during the last week during RT and 6 weeks after RT.|||percentage of participants|||Number
2706114|NCT01198145|Secondary|Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT|The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||percentage of participants|||Number
2706115|NCT01198145|Secondary|Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0|Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||Average Grade of Event||Standard Deviation|Mean
2706124|NCT01198132|Secondary|Cumulative Probability of Progression of Disability (Kaplan-Meier Curves)|Disability progression was assessed using Expanded disability status scale (EDSS). EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A one-point increase on the EDSS scale was considered as a progression in disability. The time to disability progression was summarized using Kaplan-Meier survival methods. The cumulative probability of confirmed disease progression at each visit was obtained by applying a Kaplan-Meier method to the time to confirmed disease progression.|Baseline up to week 96|"ITT set included all randomized subjects. Here Number of participant analyzed signifies those subjects who were evaluable for this outcome measure."|||percentage of subjects|||Number
2706116|NCT01198145|Secondary|Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT|For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||grade*week||Standard Deviation|Mean
2706117|NCT01198145|Secondary|Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT|"The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type.~Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type."|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used for the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||Participants|||Count of Participants
2706118|NCT01198145|Primary|Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)|"The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient.~A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms."|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations.|||Participants|||Count of Participants
2706119|NCT01198132|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Abnormal Clinical Laboratory|A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and TEAE was defined as newly occurring or worsening after first dose. Clinical laboratory abnormalities are expected to be reported as adverse events if they met any criterion for seriousness, led to treatment discontinuation, required a medical intervention or were considered clinically significant by the investigator.|Baseline up to end of treatment (week 96)|Safety set included all subjects who receive at least one administration of trial medication.|||subjects|||Number
2706120|NCT01198132|Secondary|Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L)|The EQ-5D health questionnaire is a generic self-reported health-related quality of life instrument that includes a 100 mm Visual Analog Scale (VAS) to measure the general health state, as well as 5 items corresponding to one dimension each: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the VAS scale is not collected and the version 3L of the scale was used: Each dimension had 3 possible levels: 1 = no problem, 2 = some problems and 3 = extreme problems. EQ-5D-3L weighted health state index exists that combines the score of the 5 dimensions and ranges from 0 to 1 (full health). The variables for the 5 dimensions of the EQ-5D descriptive system was named 'mobility','selfcare', 'activity', 'pain', and 'anxiety'. The 5 variables contained the values for the different dimensions in the EQ-5D health profile (i.e. 1, 2, or 3).|2 years post treatment (IMP) administration|ITT set included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2706121|NCT01198132|Secondary|Change From Baseline in Measurement and Evaluation of Cognitive Ability by Paced Auditory Serial Addition Task (PASAT) Total Score At Week 96|The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The total score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score indicates higher auditory processing speed) for each trial. Change from baseline in PASAT total score at Week 96 was summarized.|Baseline, Week 96|ITT set included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2706122|NCT01198132|Secondary|Changes From Baseline in Measured Lesion Load (T2)|Baseline defined as last value recorded prior to first intake of study drug.|Baseline, Week 96|ITT set included all randomized subjects. Here “n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||cubic millimeter (mm^3)||Standard Deviation|Mean
2706123|NCT01198132|Secondary|Number of New or Extended Lesions by T1- and T2-Weighted Magnetic Resonance Imaging (MRI)||2 years post treatment (IMP) administration|"ITT set included all randomized subjects. Here Number of participant analyzed signifies those subjects who were evaluable for this outcome measure."|||lesions||Standard Deviation|Mean
2706125|NCT01198132|Secondary|Number of Relapse-Free (Documented) Subjects|The relapse-free patients after 2 years of treatment was calculated using Cochran-Mantel-Haenszel test using the site as control variable.|2 years post treatment (IMP) administration|"ITT set included all randomized subjects. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||subjects|||Number
2707270|NCT01192152|Secondary|Metformin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng*hr/mL||Standard Deviation|Mean
2706126|NCT01198132|Secondary|Mean Number of Relapses Per Subject|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Mean and standard deviation were reported.|2 years post treatment (IMP) administration|ITT set included all randomized subjects.|||relapses||Standard Deviation|Mean
2706127|NCT01198132|Secondary|Time to First Documented Relapse|Time to First Documented Relapse was calculated using Kaplan-Meier survival methods.|2 years post treatment (IMP) administration|"ITT set included all randomized subjects. Here Number of participant analyzed signifies those subjects who were evaluable for this outcome measure."|||weeks||95% Confidence Interval|Median
2706128|NCT01198132|Primary|Annualized Relapse Rate|The annualized relapse rate was calculated for each treatment group as follows: the number of relapses observed during the study period divided by the time spent in the study (in years).|2 years post treatment (IMP) administration|ITT set included all randomized subjects.|||Relapse per year||95% Confidence Interval|Mean
2706129|NCT01198002|Other Pre-specified|Number of Participants Who Died During Post-Treatment Follow-Up Period||Discontinuation from study treatment up to 48 weeks during follow-up period|All randomized participants who received at least 1 dose of study drug and entered post-treatment follow-up period.|||Participants|||Count of Participants
2706130|NCT01198002|Secondary|Change From Baseline in CRP|CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||milligrams/liter (mg/L)||Standard Error|Least Squares Mean
2706131|NCT01198002|Secondary|Time to ACR20 Response|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.|Baseline through 52 weeks|All randomized participants with evaluable ACR20 responder data. The number of participants censored are 128 (120 mg LY2127399), 123 (90 mg LY2127399) and 162 (placebo).|||weeks||95% Confidence Interval|Median
2706132|NCT01198002|Secondary|Percentage of Participants With ACR20 at Week 52|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint.|Baseline through 52 weeks|All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2706133|NCT01198002|Secondary|Change From Baseline to Week 52 in Absolute B Cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||cells/microliter (cells/µL)||Standard Error|Least Squares Mean
2706134|NCT01198002|Secondary|Change From Baseline to Week 52 in HAQ-DI|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706135|NCT01198002|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)|Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
2706224|NCT01197560|Secondary|Stage 2: Duration of Response (DoR)|Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).|Approximately 3.5 years|DoR not analyzed; the Stage 1 results as assessed by the independent response adjudication committee (IRAC), demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706136|NCT01198002|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)|Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
2706137|NCT01198002|Secondary|Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]|Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706138|NCT01198002|Secondary|Change From Baseline in Swollen Joint Count (66 Joint Count)|Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
2706139|NCT01198002|Secondary|Change From Baseline in Tender Joint Count (68 Joint Count)|Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
2706140|NCT01198002|Secondary|American College of Rheumatology Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.|Baseline through 24 weeks and 52 weeks|All randomized participants with evaluable ACR-N data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of improvement||Standard Error|Least Squares Mean
2706141|NCT01198002|Secondary|Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||units on a scale||Standard Error|Least Squares Mean
2706142|NCT01198002|Secondary|Change From Baseline in Serum Immunoglobulin (Ig) Levels|Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||grams/liter (g/L)||Standard Error|Least Squares Mean
2706143|NCT01198002|Secondary|Change From Baseline to Week 24 in mTSS|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||units on a scale||Standard Error|Least Squares Mean
2706220|NCT01197560|Secondary|Stage 2: Overall Response Rate for With a Duration of Response Lasting ≥ 16 Weeks|Complete Response + Complete Response unconfirmed + Partial Response for participants with a duration of response lasting ≥ 16 weeks based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).|Approximately 3.5 years|Overall Response Rate for with a Duration of Response Lasting ≥ 16 weeks was not analyzed: the Stage 1 results as assessed by the IRAC, demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706144|NCT01198002|Secondary|Percentage of Participants With No Structural Progression at Week 52|No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.|Baseline through 52 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||percentage of participants|||Number
2706145|NCT01198002|Secondary|Percentage of Participants Developing Anti-LY2127399 Antibodies|Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.|Baseline through 52 weeks|All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2706146|NCT01198002|Secondary|Population Pharmacokinetics (PK): Constant Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|Baseline through 52 weeks|All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliter per hour (mL/h)||95% Confidence Interval|Mean
2706147|NCT01198002|Secondary|Change From Baseline to Week 52 in B Cell Subset Counts|B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable B cell subset counts data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||cells/microliter (cells/µL)||Standard Error|Least Squares Mean
2706148|NCT01198002|Secondary|Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.|Baseline through 24 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||percentage of participants|||Number
2706149|NCT01198002|Secondary|Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks||Baseline through 52 weeks|Zero participants analyzed. Per protocol and statistical analysis plan (SAP) amendments, the major clinical response classification was not collected for analysis.||||||
2706150|NCT01198002|Secondary|Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores|The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706151|NCT01198002|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes)|The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||minutes||Standard Error|Least Squares Mean
2706158|NCT01198002|Primary|Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 Weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||units on a scale||Standard Error|Least Squares Mean
2706152|NCT01198002|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score|The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706153|NCT01198002|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If < 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706154|NCT01198002|Secondary|Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response|EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.|Baseline through 24 weeks and 52 weeks|All randomized participants with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2706155|NCT01198002|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706156|NCT01198002|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No.) of ACR50 responders) / (No. of Pts treated) * 100. ACR70 Responder: had ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.|Baseline through 24 weeks and 52 weeks|All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2706157|NCT01198002|Primary|Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks|All randomized participants with evaluable HAQ-DI data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
2706159|NCT01198002|Primary|Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.|Baseline through 24 weeks|All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
2706160|NCT01197911|Secondary|Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters|Laboratory parameters included hematology, coagulation, biochemistry, and urinalysis. A marked abnormality was defined as a test result which was outside of the marked abnormality range. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
2706161|NCT01197911|Secondary|Number of Participants With Low and High Vital Signs Values|Vital signs were assessed after participants had rested in a supine position for no less than 5 minutes. Vital signs included systolic blood pressure, diastolic blood pressure, pulse rate, and oral body temperature. The normal ranges of vital signs were: systolic blood pressure as 90-140 millimeter of Hg (mm Hg), diastolic blood pressure as 50-90 mm Hg, pulse rate as 45-100 beats per minute, and oral body temperature as 36.3-37.5 degree Celsius. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Days -28 to -2, Day -1, Days 1 to 5, and Day 10 for blood pressure and pulse rate; and Days -28 to -2, Day -1, and Day 10 for oral body temperature|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
2706162|NCT01197911|Secondary|Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values|The ECG evaluations were performed after participants were at rest and in supine position for at least 5 minutes before recording and remain resting and supine during the recordings. ECGs parameters included heart rate (HR), RR interval, PR interval, QRS duration, QT interval, QTcB, and QTcF intervals. The normal ranges of ECG parameter values were: HR as 40-100 beats per minute, RR as 600-1500 milliseconds (msec), PR as 120-200 msec, QRS as 80-120 msec, QT as 200-500 msec, QTcB as 350-450 msec, and QTcF as 350-450 msec. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Screening (Days -28 to -2), baseline (Day -1), Days 1 to 5, and follow-up visit (Day 10)|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
2706163|NCT01197911|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
2706164|NCT01197911|Secondary|Apparent Unbound Total Body Clearance (CL/Fu) of Aleglitazar|CL/F is an apparent total clearance of the drug from plasma after oral administration. It was calculated as dose/AUCinf. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific study drug/metabolite were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2706165|NCT01197911|Secondary|Apparent Unbound Volume of Distribution (Vz/Fu) of Aleglitazar|VzF/u is an apparent volume of Unbound distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||L||Geometric Coefficient of Variation|Geometric Mean
2706166|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to 48 Hours Post-dose (AUCu,0-48)|AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706167|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From 0 to the Last Quantifiable Time-point Post-dose (AUCu,Last)|Plasma samples were collected for this PK parameter. AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero 0 to the last quantifiable time-point post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. AUClast was extrapolated to AUCinf by adding the ratio of Clast/kel to the AUClast, where Clast was the last observed concentration and kel was elimination rate constant.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706168|NCT01197911|Secondary|Maximum Unbound Plasma Concentration (Cmax,u) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706169|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to Infinity (AUCu,Inf)|AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. It was assessed using an analysis of variance model on the log-transformed values of AUCinf of aleglitazar with hepatic impairment group as factor.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706170|NCT01197911|Secondary|Mean of Fraction of Unbound Aleglitazar (fu)|fu was calculated using the mean of the 2-hour (reflecting Cmax) and 24-hour (reflecting Ctrough) values for each participant or, if the result of only one time-point was available, fu was the result of the available time-point. Ctrough) is a measured concentration at the end of a dosing interval at steady state.|2 and 24 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2706171|NCT01197911|Secondary|Fraction of Drug Excreted in Urine From Time 0 to 48 Hours Post-dose (fe0-48) of Aleglitazar|fe0-48 was calculated as Ae0-48/dose. The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours. Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||mcg||Geometric Coefficient of Variation|Geometric Mean
2706172|NCT01197911|Secondary|Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6|The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours, where Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||mcg||Geometric Coefficient of Variation|Geometric Mean
2706173|NCT01197911|Secondary|Apparent Volume of Distribution (Vz/F) of Aleglitazar|Vz/F is the apparent volume of distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||L||Geometric Coefficient of Variation|Geometric Mean
2706174|NCT01197911|Secondary|Elimination Rate Constant (Kel) of Aleglitazar|The kel is fraction of a substance that is removed per unit time measured at any particular instant. It was calculated using at least 3 concentration-time points and ideally covered more than 2 half-lives.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2706175|NCT01197911|Secondary|Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h||Geometric Coefficient of Variation|Geometric Mean
2706176|NCT01197911|Secondary|Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Tmax was measured as time to reach the maximum concentration in the plasma after post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||h||Full Range|Mean
2707908|NCT01188460|Primary|Insomnia Severity Index (ISI)|Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes|Timepoint 2 (week 7 of study participation)||||units on a scale||Standard Deviation|Mean
2706177|NCT01197911|Secondary|Apparent Non-renal Clearance (CLNR/F) of Aleglitazar|Plasma and urine samples were collected for this PK parameter. CLNR/F was estimated as CL/F, based on the approximated formula of CLNR/F = (CL-CLR)/F with CLR of aleglitazar being equal to zero. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time zero to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2706178|NCT01197911|Secondary|Renal Clearance (CLR) of Aleglitazar, M1, and M6|CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time 0 to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72, and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2706179|NCT01197911|Secondary|Apparent Total Body Clearance (CL/F) of Aleglitazar|CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2706180|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6|AUClast was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706181|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUC0-48 was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706182|NCT01197911|Secondary|Cmax of M1 and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706183|NCT01197911|Primary|Maximum Plasma Concentration (Cmax) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706184|NCT01197911|Secondary|AUCinf of M1 (RO4408754) and M6 (RO4583746)|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706185|NCT01197911|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar|AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.|||hours (h)*nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2706186|NCT01197898|Primary|Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.|The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.|28 Days|Goal was to complete 10 subjects in an allocation ratio of 1:1 for Santyl vs. placebo. Since this was an exploratory study, the sample size was arbitrary.|||participants|||Number
2706187|NCT01197833|Primary|Absolute Change From Baseline in PA-V3 Score|"The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4)"|PA-V3 measured at baseline and then at 8 weeks||||score||Standard Error|Least Squares Mean
2707934|NCT01188369|Secondary|E/A-ratio (Unitless)|Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.|1 hour before operation until 21 hours after operation|||||||
2706188|NCT01197833|Primary|Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)|The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.|IPR-V3 measured at baseline and then at 8 weeks||||score||Standard Error|Least Squares Mean
2706189|NCT01197794|Secondary|Total Reliever Medication Use|Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Number of inhalations||95% Confidence Interval|Least Squares Mean
2706190|NCT01197794|Secondary|Asthma Symptom Score|Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Score on scale||95% Confidence Interval|Least Squares Mean
2706191|NCT01197794|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S))|The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Score on scale||95% Confidence Interval|Least Squares Mean
2706192|NCT01197794|Secondary|Number of Participants With Well-controlled Asthma (ACQ5<=0.75)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Participants|||Number
2706193|NCT01197794|Secondary|Number of Participants With at Least One Treatment Failure|Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Participants|||Number
2706194|NCT01197794|Secondary|Number of Participants With at Least One Severe Asthma Exacerbation|Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Participants|||Number
2706195|NCT01197794|Secondary|Adverse Events|Number of participants who had at least one adverse event during the randomized treatment period|Twelve week treatment period|All randomized participants who received at least one dose of study medication and from whom any data after randomization was available|||Participants|||Number
2706196|NCT01197794|Secondary|Asthma Control Questionnaire 5-item (ACQ5)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Scores on scale||95% Confidence Interval|Least Squares Mean
2706197|NCT01197794|Secondary|Morning and Evening PEF|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Liters/minute||95% Confidence Interval|Least Squares Mean
2706198|NCT01197794|Primary|Pre-bronchodilator FEV1 at the Clinic|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Liters||95% Confidence Interval|Least Squares Mean
2706221|NCT01197560|Secondary|Stage 2: Duration of Complete Response|Length of time of complete response (Complete Response + Complete Response unconfirmed) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).|Approximately 3.5 years|Duration of CR was not analyzed; the Stage 1 results as assessed by the independent response adjudication committee (IRAC), demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706199|NCT01197755|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. The SF-36 scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in score at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2706200|NCT01197755|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2706201|NCT01197755|Secondary|Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for eroisions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = Analysis of covariance, BID = twice daily, IP = investigational product, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.|||Units on a scale||Standard Deviation|Mean
2706202|NCT01197755|Secondary|Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706203|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 24 was categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706204|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706205|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706222|NCT01197560|Other Pre-specified|Stage 2: Progression-Free Survival|Number of participants who survive without progressing based on the International Working Group Response Criteria [IWG].|Approximately 3.5 years|PFS not analyzed; the Stage 1 results as assessed by the independent response adjudication committee (IRAC), demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706206|NCT01197755|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 24. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
2706207|NCT01197755|Secondary|Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706208|NCT01197755|Secondary|Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706209|NCT01197755|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706210|NCT01197755|Primary|Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706211|NCT01197612|Secondary|Sinonasal Health|Assessed with Perioperative Sinus Endoscopy (POSE) score|24 weeks post operation|Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants|||units on a scale||Full Range|Mean
2706212|NCT01197612|Secondary|Olfaction|Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification|24 weeks post operation|Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5|||units on a scale||Full Range|Mean
2706213|NCT01197612|Secondary|Sinonasal Health|will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.|3 weeks post operation|unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed|||units on a scale||Full Range|Mean
2706214|NCT01197612|Primary|Olfaction|will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification|3 weeks post-operation|Of sixteen participants at the three week mark, one participant's data was unable to be unblinded accurately, and one participant had no UPSIT scores taken, leaving an analysis population of 14,|||units on a scale||Full Range|Mean
2706215|NCT01197573|Secondary|Number of Participants With Liver Ischemic-Type Biliary Strictures||1 year||||Participants|||Count of Participants
2706216|NCT01197573|Primary|Number of Participants With Primary Liver Graft Nonfunction||1 month||||Participants|||Count of Participants
2706217|NCT01197573|Primary|Delayed Kidney Graft Function||3 months||||Participants|||Count of Participants
2706218|NCT01197560|Secondary|Stage 2: Health Related Quality of Life Questionnaires|Quality of Life based on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D assessments|Approximately 3.5 years|Health Related Quality of Life Instruments were not analyzed; the Stage 1 results as assessed by the IRAC, demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706219|NCT01197560|Secondary|Stage 2: Time to Progression|Length of time until disease progression occurs|Approximately 3.5 years|Time to progression was not analyzed; the Stage 1 results as assessed by the IRAC, demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706223|NCT01197560|Secondary|Stage 2: Overall Survival (OS)|Overall survival was defined as time from randomization until death of any cause.|Approximately 3.5 years|OS not analyzed; the Stage 1 results as assessed by the independent response adjudication committee (IRAC), demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706225|NCT01197560|Secondary|Stage 2: Overall Response Rate (ORR)|ORR is defined as: Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).|Approximately 3.5 years|ORR not analyzed; the Stage 1 results as assessed by the independent response adjudication committee (IRAC), demonstrated that neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
2706226|NCT01197560|Secondary|Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment|"A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death"|From first dose of study drug to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|Safety Population included all participants who received at least one dose of lenalidomide or IC regimen.|||Participants|||Count of Participants
2706227|NCT01197560|Other Pre-specified|Stage 1: Kaplan Meier Estimates of Overall Survival As Assessed by the Investigators at the Final Data Cut During The Core Treatment Phase|Overall survival was defined as time from randomization until death of any cause.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|mITT was defined as all participants randomized who had a DLBCL diagnosis confirmed by central pathology, had either GCB or non-GCB subtype and received at least one dose of study drug or investigators choice regimen.|||Weeks||95% Confidence Interval|Median
2706228|NCT01197560|Other Pre-specified|Stage 1: Kaplan Meier Estimates of Progression-Free Survival As Assessed By The Investigators At The Final Data Cut During The Core Treatment Phase|Progression-free survival was defined as the time from randomization to the first documented disease progression or death due to any cause.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|mITT was defined as all participants randomized who had a DLBCL diagnosis confirmed by central pathology, had either GCB or non-GCB subtype and received at least one dose of study drug or investigators choice regimen.|||Weeks||95% Confidence Interval|Median
2706229|NCT01197560|Other Pre-specified|Stage 1: Kaplan Meier Estimates of Duration of Complete Response (DoCR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase|Duration of complete response was defined as the time from the first documented complete response (CR + CRu) until the first disease progression or death for participants who had a CR.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|For DoCR, the population included participants who had a CR.|||Weeks||95% Confidence Interval|Median
2706230|NCT01197560|Other Pre-specified|Stage 1: Kaplan Meier Estimates of Duration of Overall Response (DoR) as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase|Duration of overall response was calculated as the time of initial response (CR+CRu+PR) until documented disease progression determinted by computerized scan CT scan or MRI or death due to lymphoma, whichever occurred earlier, for participants who responded.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|For DoR, the population included participants who had an overall response.|||Weeks||95% Confidence Interval|Median
2706231|NCT01197560|Other Pre-specified|Stage 1: Percentage of Participants With a Complete Response According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase|A complete response was defined as participants with a complete response (CR), or unconfirmed complete response (CRu) based on IWG 1999 Response Criteria for NHL as assessed by the investigator. A CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRu) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|mITT was defined as all participants randomized who had a DLBCL diagnosis confirmed by central pathology, had either GCB or non-GCB subtype and received at least one dose of study drug or investigators choice regimen.|||percentage of participants||95% Confidence Interval|Number
2706232|NCT01197560|Other Pre-specified|Stage 1: Percentage of Participants With a Durable Overall Response (dORR) According to the IWG Response Criteria as Assessed by the Investigators at the Final Data Cut During the Core Treatment Phase|Durable overall response rate was defined as the percentage of participants who maintained a response for at least 16 weeks after initial response.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|mITT was defined as all participants randomized who had a DLBCL diagnosis confirmed by central pathology, had either GCB or non-GCB subtype and received at least one dose of study drug or investigators choice regimen.|||percentage of participants||95% Confidence Interval|Median
2706248|NCT01197534|Secondary|Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2707935|NCT01188369|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)|Transthoracic echocardiographic measure of systolic function|96 hours after operation until 6 months after operation|||||||
2706233|NCT01197560|Primary|Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase|Response was defined as having a CR, CRu or PR, based on IWG 1999 Response Criteria for NHL as evaluated by the investigators. CR = complete disappearance of disease and disease related symptoms. All lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical exam, normal size by imaging, and absence of nodules related to lymphoma. If BM was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new disease.|From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.|mITT was defined as all participants randomized who had a DLBCL diagnosis confirmed by central pathology, had either GCB or non-GCB subtype and received at least one dose of study drug or investigators choice regimen.|||Percentage of participants||95% Confidence Interval|Number
2706234|NCT01197560|Primary|Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC)|An overall response is a complete response (CR), unconfirmed complete response (CRu) or partial response (PR) and was evaluated by the IRAC. A CR = complete disappearance of disease and related symptoms. Lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on exam, normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter;no new disease.|From the date of randomization to the data cut-off of 4 July 2013; when all patients reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment); the median study duration was 27.0 and 19.7 weeks, respectively.|The Modified Intent to Treat (mITT) population was defined as all participants randomized who had a diffuse large B-cell lymphoma (DLBCL) diagnosis and either germinal center B-cell subtype (GCB) or non-GCB subtype confirmed by central pathology, and who received at least one dose of study drug (lenalidomide or investigator’s choice).|||percentage of participants||95% Confidence Interval|Number
2706235|NCT01197547|Secondary|Serious Adverse Device Effect (SADE)|A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune.|Day 1|992 - Intent-To-Treat (ITT) population|||number of participants|participants||Number
2706236|NCT01197547|Secondary|Technical Malfunctions|A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit.|Day 1|992 patients = ITT population|||percent of participants||95% Confidence Interval|Number
2706237|NCT01197547|Primary|Burn Rate||Day 1||||participants|||Number
2706238|NCT01197534|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2706239|NCT01197534|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2706274|NCT01197508|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2706240|NCT01197534|Secondary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.|||Units on a scale||Standard Deviation|Mean
2706241|NCT01197534|Secondary|HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706242|NCT01197534|Secondary|Proportion of Patients Achieving DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706243|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706244|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706245|NCT01197534|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
2706246|NCT01197534|Secondary|Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706247|NCT01197534|Secondary|Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706318|NCT01196988|Secondary|Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results|||Participants|||Count of Participants
2706249|NCT01197534|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706250|NCT01197521|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle|||Units on a scale||Standard Deviation|Mean
2706251|NCT01197521|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle|||Units on a scale||Standard Deviation|Mean
2706252|NCT01197521|Secondary|HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706253|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706254|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706255|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706256|NCT01197521|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
2706257|NCT01197521|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706258|NCT01197521|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706259|NCT01197521|Secondary|ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706260|NCT01197521|Primary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.|mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of IP. Patients were analysed by randomised treatment. Measurements at 2 timepoints are required in order for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.|||Units on a scale||Standard Deviation|Mean
2706261|NCT01197521|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2706262|NCT01197508|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706263|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706264|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706299|NCT01197378|Secondary|Trough Plasma Cysteamine Concentration|Plasma cysteamine concentration was determined using methods employing Hydrophilic Interaction Liquid Chromatography (HILC) high pressure liquid chromatography (HPLC) tandem mass spectrometry (HPLC-MS/MS).|Day 1 (predose) and Month 6, Years 1, 1.5, 2, 3, 4 and 5 at 0.5 hours post-dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Population includes all participants who had at least one PK/PD measurement. Day 1 results only include participants who did not complete Study RP103-03.|||mg/L||Standard Deviation|Mean
2706265|NCT01197508|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706266|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706267|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706268|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706269|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706270|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706271|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706272|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706273|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706388|NCT01196819|Secondary|Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)||5 years after index PCI|6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted.|||Participants|||Count of Participants
2706275|NCT01197508|Secondary|"Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of Very Much Improved or Much Improved From Randomization (Week 8) to End of Treatment (Week 16)"|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2706276|NCT01197508|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706277|NCT01197508|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706278|NCT01197508|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2706279|NCT01197508|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
2706280|NCT01197508|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2706281|NCT01197508|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2706282|NCT01197508|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2706389|NCT01196819|Secondary|Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)||3 years after index PCI|3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted.|||Participants|||Count of Participants
2706283|NCT01197508|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2706284|NCT01197495|Secondary|Duration Effect of Treatment on Lip Fullness|Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.|Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12|Modified Intent-to-Treat: all treated subjects with data at the designated time point|||% of Pts Retaining ≥1-point Improvement||95% Confidence Interval|Number
2706285|NCT01197495|Secondary|Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness|Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'|Baseline, Month 3|Treated subjects in the Treatment group|||Percentage of Subjects|||Number
2706286|NCT01197495|Secondary|Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale|Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).|Baseline, Month 3|Subjects treated for OCS at the designated time points|||Percentage of Oral Commissures|Oral Commissures||Number
2706287|NCT01197495|Secondary|Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale|Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).|Baseline, Month 3|Subjects treated for POL at the designated time points|||Percentage of Subjects|||Number
2706288|NCT01197495|Primary|Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)|Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.|Baseline, Month 3|Modified Intent-to-Treat: all treated subjects with data at the designated time point|||Percentage of Subjects||95% Confidence Interval|Number
2706289|NCT01197456|Secondary|Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea|Number of participants who experience return of menses after 3 months of amenorrhea|Years 1-5|We did not undertake this analysis for participants who did not undergo chemotherapy (unexposed) or were censored for recurrence, death, hysterectomy or bilateral salpingo-oophorectomy (n=108) as this measure is not applicable|||Participants|||Count of Participants
2706290|NCT01197456|Primary|Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis|Number of participant without of menses for 12 months after breast cancer diagnosis|Years 1-5|"25 participants could not be evaluated for this outcome due to censoring for cancer recurrence, death, bilateral salpingo-oophorectomy, or hysterectomy.~38 additional participants could not be evaluated for this outcome due to loss to follow up."|||Participants|||Number
2706291|NCT01197417|Secondary|Hospital Length of Stay||Start of first study drug infusion to actual hospital discharge||||Hours||Inter-Quartile Range|Median
2706292|NCT01197417|Secondary|Development of Acute Chest Syndrome (ACS)||Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment||||Paricipants|||Number
2706293|NCT01197417|Secondary|Rehospitalization||Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)|All participants who received at least one dose of study drug who had known rehospitalization status within 7 days|||Participant|||Number
2706294|NCT01197417|Secondary|Warm Sensation Associated With Study Drug Infusion|Patient spontaneously reported feelings of warmth during any study drug infusion.|Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug.|||Participant|||Number
2706295|NCT01197417|Secondary|Hypotension Associated With Infusion|For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.|Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug|||Participant|||Number
2706296|NCT01197417|Secondary|Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization||Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to either hospital discharge or 12 hours after last intravenous opioid.|||mg Morphine/kg||Inter-Quartile Range|Median
2706297|NCT01197417|Primary|Hospital Length of Stay (Hours)||From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to outcome|||hours||Inter-Quartile Range|Median
2706298|NCT01197378|Secondary|White Blood Cell Cystine Concentration|White blood cell (WBC) cystine concentration was determined using high performance liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS).|Day 1 (predose) and Month 6, Years 1, 1.5, 2, 3, 4 and 5 at 0.5 hours post-dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Population includes all participants who had at least one PK/PD measurement. Day 1 results only include participants who did not complete Study RP103-03.|||nmol 1/2 Cystine/mg protein||Standard Deviation|Mean
2706390|NCT01196819|Secondary|Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)||1 years after index PCI||||Participants|||Count of Participants
2706300|NCT01197378|Primary|Number of Participants With Treatment-emergent Adverse Events|"Drug-related adverse events (AEs) are AEs the investigator assessed as having relation to drug of 'possibly', 'probably' or 'definitely'.~The severity of AEs was categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 as follows:~Mild (Grade 1): experience is minor and does not cause significant discomfort to subject or change in activities of daily living (ADL); subject is aware of symptoms but symptoms are easily tolerated;~Moderate (Grade 2): experience is an inconvenience or concern to the subject and causes interference with ADL, but the subject is able to continue with ADL.~Severe (Grade 3): experience significantly interferes with ADL and the subject is incapacitated and/or unable to continue with ADL~Life-threatening (Grade 4): experience that, in the view of the Investigator, places the subject at immediate risk of death from the event as it occurred."|From first dose of study drug to 7 days after the last dose; median duration of treatment was 1461 days.|All participants who received at least 1 dose of cysteamine bitartrate.|||Participants|||Count of Participants
2706301|NCT01197326|Secondary|Respiration Rate Impact on RRT Calls|Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.|6 months||||percentage of calls|||Number
2706302|NCT01197326|Primary|Survival|Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)|6 months||||percentage of participants|||Number
2706303|NCT01197300|Secondary|Mean Change From Baseline (Core and Extension) in 2nd Metacarpal Cortical Width at Month 24 by Core Treatment Group.|Left postero-anterior (PA) hand/wrist X-ray were taken at the final visit of Core study and at Visit 15/EOS (Month 24) to assess bone age. The change in 2nd metacarpal cortical width at Month 24 relative to the respective Baseline was calculated. If a fracture of the left upper extremity precluded radiographic imaging, (or precluded this X-ray in the Core study) then the right hand was evaluated for this purpose. In this case, an image of the right hand was carried out at both Visit 8 and at Visit 15/EOS (Month 24). The information was used in the assessment of bone density.|Baseline 1 (Visit 1 of the Core Study) and Baseline 2 (Visit 9 of the Extension Study) through Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||millimeter (mm)||Standard Error|Least Squares Mean
2706304|NCT01197300|Secondary|Percentage of Patients With Reduction in Pain From Baseline 1 (Visit 1 of the Core Study) at Month 15, 18, 21 and 24 by Core Treatment Group.|Pain was evaluated at each visit (at office and telephone visit) at the final visit of the Core study and first visit of the Extension study (Visit 9), Visits 11 (Month 15), 12 (Month 18), 14 (Month 21) and 15 (Month 24) using the Faces Pain Scale-Revised (FPS-R). Children were selecting the face that best fits their pain. The pain score ranged from 0 (No Pain) to 10 (Very Much Pain). The reduction in pain from Core baseline by visit was evaluated based on whether or not patients had a decrease in their FPS-R from baseline. If pain remained the same or worsened from baseline a patient was classified as '0' and if the pain scale decreased then the patient was classified as '1'.|Month 15, Month 18, Month 21, Month 24|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||Percentage of Patients|||Number
2706305|NCT01197300|Secondary|Number of Participants With New Morphometric Vertebral Fractures During the 12 Month Extension Period by Core Treatment Group.|Vertebral morphometry (or concave index) was calculated using the average ratio between mid-height and posterior height from L1 to L4 and performed by a central reader. A new morphometric vertebral fractures during the 12 month Extension Period was defined as a morphometric vertebral fracture present at Month 24 X-ray which was not present at the Extension Baseline (Baseline 2).|Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||Participants|||Count of Participants
2706306|NCT01197300|Secondary|Number of Participants With New Vertebral Fractures During the 12 Month Extension Period by Core Treatment Group.|New vertebral fractures are defined as fractures of Genant grade 1 or higher that occur at lumbar or thoracic spine from first extension dose infusion to the end of the study in a previously normal vertebra.|Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||Participants|||Count of Participants
2706307|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in Serum TRAP-5b at Month 18 and 24 by Core Treatment Group.|Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) were collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||U/L||Standard Error|Least Squares Mean
2706308|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in Serum NTX at Month 18 and 24 by Core Treatment Group.|Serum Cross linked N-telopeptide (NTX) was collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||nmol BCE/L||Standard Error|Least Squares Mean
2706391|NCT01196819|Secondary|TLF(Target Lumen Failure)|percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.|5 years after index PCI|6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted.|||percentage|||Number
2706309|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in BSAP at Month 18 and 24 by Core Treatment Group.|Bone specific alkaline phosphatase (BSAP) was collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||nanogram per milliliter (ng/mL)||Standard Error|Least Squares Mean
2706310|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in Serum P1NP at Month 18 and 24 by Core Treatment Group.|Serum Procollagen type 1 amino-terminal propeptide (P1NP) was collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||nanogram per milliliter (ng/mL)||Standard Error|Least Squares Mean
2706311|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in Total Body BMC at Month 18 and 24 by Core Treatment Group.|Total body BMC were determined by the central imaging vendor at the final visit of Core study (Visit 8) or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension Study visit/EOS) of Extension study. The methods to be used to measure BMC were described in the respective DXA Manuals. Positive changes from Core baseline indicated an improvement in condition.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||gram||Standard Error|Least Squares Mean
2706312|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in Lumbar Spine Bone Mineral Content (BMC) at Month 18 and 24 by Core Treatment Group.|Lumbar Spine Bone Mineral Content (BMC) was determined by the central imaging vendor at the final visit of Core study (Visit 8) or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension Study visit/EOS) of Extension study. The methods to be used to measure BMC were described in the respective DXA Manuals. Positive changes from Core baseline indicated an improvement in condition.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||gram||Standard Error|Least Squares Mean
2706313|NCT01197300|Secondary|Mean Change From Baseline 1 (Visit 1 of the Core Study) in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 18 and 24 by Core Treatment Group.|Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor at the final visit of Core study (Visit 8) or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension Study visit/EOS) of Extension study. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from Core baseline indicated an improvement in condition.|Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)|The Full Analysis population, which consisted of all randomized patients who had both Core Baseline and at least one post-baseline lumbar spine BMD Z-score in the Extension study, was considered.|||Z-score||Standard Error|Least Squares Mean
2706314|NCT01197300|Primary|Long-term Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids.|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that zoledronic acid given long-term, over an additional 12 months from the Core study (CZOL446H2337), is safe for the treatment of osteoporotic children treated with glucocorticoids through the monitoring of relevant clinical and laboratory safety parameters.|Baseline 1 (Visit 1 of the Core Study) through Month 24 (Visit 15/Final Extension Visit)|The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug, was considered.|||Participants|||Count of Participants
2706315|NCT01196988|Secondary|Number of Days With Solicited General Symptoms|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)].|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||days||Inter-Quartile Range|Median
2706316|NCT01196988|Secondary|Number of Days With Solicited Local Symptoms.|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||days||Inter-Quartile Range|Median
2706317|NCT01196988|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.|||Participants|||Count of Participants
2707936|NCT01188369|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)|Transthoracic echocardiographic measure of systolic function|21 hours after operation until 96 hours after operation|||||||
2706319|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.|||Participants|||Count of Participants
2706320|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 28-day (Days 0-27) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.|||Participants|||Count of Participants
2706321|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||Participants|||Count of Participants
2706322|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||Participants|||Count of Participants
2706323|NCT01196988|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child <6 years) or pain that prevented normal activity (Child >6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.|||Participants|||Count of Participants
2706324|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold change||95% Confidence Interval|Geometric Mean
2706325|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold change||95% Confidence Interval|Geometric Mean
2706326|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold change||95% Confidence Interval|Geometric Mean
2706392|NCT01196819|Secondary|TLF(Target Lumen Failure) Rate|percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.|3 years after index PCI (Percutaneous Coronary Intervention)|3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted.|||percentage|||Number
2706327|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706328|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706329|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706330|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706331|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706332|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706333|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706334|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706393|NCT01196819|Secondary|Target Lesion Failure(TLF) Rate|Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|1 years after index PCI||||percentage|||Number
2706335|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706336|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706337|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706338|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).~Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2706339|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).~Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2706340|NCT01196988|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706341|NCT01196988|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2706342|NCT01196975|Secondary|Number of Days With Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.|Within the 21-day (Days 0-20) follow-up period post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||||||
2706394|NCT01196819|Secondary|9 Months In-stent Diameter Stenosis|the in-stent diameter stenosis 9 months post-procedure|9 months|Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.|||percentage of diameter stenosis||Standard Deviation|Mean
2706343|NCT01196975|Secondary|Number of Days With Solicited General Symptoms After Vaccination|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||||||
2706344|NCT01196975|Secondary|Number of Days With Solicited Local Symptoms After Vaccination.|Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||||||
2706345|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2706346|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature - oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||Participants|||Count of Participants
2706347|NCT01196975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||Participants|||Count of Participants
2706348|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2706349|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2706350|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706351|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2707937|NCT01188369|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)|Transthoracic echocardiographic measure of systolic function|1 hour before operation until 21 hours after operation|||||||
2706352|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.|||Titer||95% Confidence Interval|Geometric Mean
2706353|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2706354|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2706355|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706356|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706357|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706358|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2706359|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.|||Titer||95% Confidence Interval|Geometric Mean
2706395|NCT01196819|Primary|9 Months In-stent Late Lumen Loss|To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure|9 months|Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.|||mm||Standard Deviation|Mean
2706360|NCT01196975|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2706361|NCT01196975|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.|||Participants|||Count of Participants
2706362|NCT01196975|Secondary|Number of Subjects With Related Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.||||||
2706363|NCT01196975|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.|||Participants|||Count of Participants
2706364|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples.|||titer||95% Confidence Interval|Geometric Mean
2706365|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2706366|NCT01196975|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2706367|NCT01196936|Secondary|Biomarker Levels - Urine N-telopeptide|Urine n-telopeptide measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.|Up to 2 years||||nM Bone Collagen Equiv. / nM Creatinine||Standard Error|Least Squares Mean
2706368|NCT01196936|Secondary|Biomarker Levels - Alkaline Phosphatase|Serum bone-specific alkaline phosphatase measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.|Up to 2 years||||ug/L||Standard Error|Least Squares Mean
2706369|NCT01196936|Secondary|Insulin Growth Factor Levels (IGF3 )|IGF3 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed.|Up to 2 years||||ng/mL||Standard Error|Least Squares Mean
2706370|NCT01196936|Secondary|Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire|The outcomes will be scored as a 5-point Likert-type scale (0-4) in response to questions on how much the patients are bothered by certain symptoms. The questionnaire will be administered every 6 months. The responses will be treated as normally distributed, as ordinal or dichotomized variable, and the linear mixed effects of general linear mixed model (GLMM) methods will be applied to compare changes between treatment groups. Piecewise models will also be fitted with join point at 6 months, considering linear and curvilinear trajectories between 6 and 24 month time points.|Up to 2 years|Symptoms with >10% prevalence are reported; patients were dichotomized into 2 groups: those that rated the symptom as moderately or extremely bothersome vs. slightly or quite a bit bothersome|||participants|||Number
2706371|NCT01196936|Secondary|Percentage of Pills Taken Out of the Total Prescribed|The number of pills taken out of the total prescribed in a 3-month period will be modeled as a random effects binomial regression model. The binomial rates from 8 time points (month 3-24) will be modeled as unstructured mean model with 7 indicator variables as well as polynomial models over time. The random-intercept and the random intercept and slope models will be considered. The significance of the time indicators or parameters by treatment interaction will be evaluated for treatment difference in compliance.|Up to 2 years||||percentage of pills taken||Full Range|Median
2706372|NCT01196936|Secondary|Biomarker Levels|Total cholesterol, low and high density lipoprotein, triglycerides, and anti-thrombin III enzymatic assay measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time.|Up to 2 years||||mg/dL||Standard Error|Least Squares Mean
2706373|NCT01196936|Secondary|Number of Grade 2-4 Toxicities|Will be tabulated by treatment arm. Differences by treatment arm will be evaluated using Fisher exact tests.|Up to 2 years||||Adverse Events|||Number
2706374|NCT01196936|Secondary|Insulin Growth Factor Levels (IGF1)|IGF1 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed.|Up to 2 years||||ng/mL||Standard Error|Least Squares Mean
2706375|NCT01196936|Primary|Mammographic Breast Density|Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data.|At year two post treatment||||percentage of fibrogladular tissue||Standard Error|Least Squares Mean
2706376|NCT01196923|Primary|Acute Isolation of Pulmonary Veins.|99% of pulmonary veins were isolated (72/73)|Acute PVI measured on the day of treatment|All treated participants with reported data.|||percent isolated pulmonary veins|||Number
2706377|NCT01196871|Secondary|Change From Baseline To Day 7 In Active α-Gal A In Skin Following Treatment With Agalsidase Alone And Co-administration With Migalastat|This measure characterized the effects of agalsidase and migalastat on α-Gal A activity in the skin using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. Baseline was defined as Day 1/Period 1 pre-infusion level. α-Gal A activity is reported in picomoles/mg/hr (pmol/mg/hr). Biopsy samples were obtained: on Day -1/Period 1; 24 hr after initiation of the infusion during Period 1 and Period 2; on Day 7 of Period 1 and Period 2.|Baseline, Day 7|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||pmol/mg/hr||Full Range|Mean
2706378|NCT01196871|Primary|Change In Tmax And T1/2 For Migalastat After Administration Of Agalsidase|This measure characterized the effects of agalsidase on the plasma PK of migalastat using a validated LC-MS assay. The migalastat plasma PK parameter values for tmax and t1/2 are reported in hr. In Period 2 of Stages 1 and 2, blood samples were collected: just before dosing with migalastat (2 hr prior to the agalsidase infusion) and at 1 hr after migalastat dosing; immediately before the agalsidase infusion and over a 24-hr period after infusion. In Period 3 (Stage 1 only), blood samples were collected before dosing and over the 24-hr period after administration of migalastat.|0 hr, 1 day post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||hr||Standard Deviation|Mean
2706379|NCT01196871|Primary|Change In Cmax For Migalastat After Administration Of Agalsidase|This measure characterized the effects of agalsidase on the plasma PK of migalastat using a validated liquid LC-MS assay. The migalastat plasma PK parameter values for Cmax are reported in nmol/hr/mL. In Period 2 of Stages 1 and 2, blood samples were collected: just before dosing with migalastat (2 hr prior to the agalsidase infusion) and at 1 hr after migalastat dosing; immediately before the agalsidase infusion and over a 24-hr period after infusion. In Period 3 (Stage 1 only), blood samples were collected before dosing and over the 24-hr period after administration of migalastat.|0 hr, 1 day post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||nmol/hr/mL||Standard Deviation|Mean
2706380|NCT01196871|Primary|Change In AUC For Migalastat After Administration Of Agalsidase|This measure characterized the effects of agalsidase on the plasma PK of migalastat using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay. The migalastat plasma PK parameter values for AUCinfinity and AUC0-t are reported in hr*[ng/hr/mL]. In Period 2 of Stages 1 and 2, blood samples were collected: just before dosing with migalastat (2 hr prior to the agalsidase infusion) and at 1 hr after migalastat dosing; immediately before the agalsidase infusion and over a 24-hr period after infusion. In Period 3 (Stage 1 only), blood samples were collected before dosing and over the 24-hr period after administration of migalastat.|0 hr, 1 day post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||hr*[ng/hr/mL]||Standard Deviation|Mean
2706381|NCT01196871|Primary|Change In Tmax And T1/2 For Total α-Gal A Protein Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the total α-Gal A protein level in plasma by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter values for tmax and t1/2 are reported in hr. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||hr||Standard Deviation|Mean
2706396|NCT01196793|Primary|Number of Participants With Admission to Hospital Due to Parental High Levels of Worry|Interview with the patient family to evaluation of the reasons for admission to emergency department|7-10 days||||Participants|||Count of Participants
2706382|NCT01196871|Primary|Change In Cmax For Total α-Gal A Protein Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the α-Gal A protein level in plasma by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter values for Cmax is reported in nmol/hr/mL. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||nmol/hr/mL||Standard Deviation|Mean
2706383|NCT01196871|Primary|Change In Percentage Of AUCinfinity Extrapolated From The Last Time Point At Which Concentration Is Quantified To Infinity (AUCextrapolated %) For Total α-Gal A Protein Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the α-Gal A protein level by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter values for AUCextrapolated % are reported. AUCextrapolated % is reported instead of AUCinfinity because small but quantifiable concentrations of α-Gal A protein past 24 hr post-dose extrapolated to infinity comprised >50% of total AUC in most participants and were unevaluable. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hour after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||percentage of AUC||Standard Deviation|Mean
2706384|NCT01196871|Primary|Change In AUC For Total α-Gal A Protein Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the α-Gal A protein level in plasma by Western blot using anti-human Gal A antibody. The agalsidase plasma PK parameter value for AUC0-t is reported in hr*[nanogram (ng)/hr/mL]. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||hr*[ng/hr/mL]||Standard Deviation|Mean
2706385|NCT01196871|Primary|Change In Time To Maximum Observed Plasma Concentration (Tmax) And Terminal Elimination Half-life (T1/2) For Active α-Gal A Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter values for tmax and t1/2 are reported in hr. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||hr||Standard Deviation|Mean
2706386|NCT01196871|Primary|Change In Maximum Observed Plasma Concentration (Cmax) For Active α-Gal A Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter value for Cmax is reported in nmol/hr/mL. In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||nmol/hr/mL||Standard Deviation|Mean
2706387|NCT01196871|Primary|Change In Area Under The Plasma Concentration Versus Time Curve (AUC) For Active α-Galactosidase A (α-Gal A) Levels After Administration Of Migalastat|This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter values for AUC extrapolated from time 0 to infinity (AUCinfinity) and AUC to the last time point at which concentration is quantified (AUC0-t) are reported in hr*[nanomoles/hr/milliliter] (hr*[nmol/hr/mL]). In Period 1 of Stages 1 and 2, blood samples were collected: immediately before the agalsidase infusion and over a 24-hr period after infusion; on Days 2, 7, and 14. In Period 2 of Stages 1 and 2, blood samples were collected: prior to dosing with migalastat (2 hr prior to the agalsidase infusion) and 1 hr after migalastat dosing; immediately before initiation of the agalsidase infusion and over a 24-hr period after initiation of the agalsidase infusion; on Days 2, 7, and 14.|0 hr, 2 hr, 2 days, 7 days, 14 days post dose|PK Population: all participants with evaluable PK parameter data who had successfully completed at least Period 1 and Period 2 in any stage. All PK analyses were performed using the PK population.|||hr*[nmol/hr/mL]||Standard Deviation|Mean
2706398|NCT01196741|Secondary|Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~Time To Progression will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||||||
2706399|NCT01196741|Secondary|Quality of Life: Trial Outcome Index (TOI) Based on FACT-O|"The TOI value for each patient is derived at each timepoint by calculating the sum of 3 subscales: Physical Well-Being (PWB), Functional Well-Being (FWB), Additional Concerns. Each subscale score is derived from questions with 4 answers (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). In each subscale reversals are performed and the individual question scores added together. This value is then multiplied by the number of questions within the subscale, and divided by the number of questions answered to derive a subscale score. The higher each subscale score, the better the QoL.~PWB 7 questions, lower values=better QoL.~FWB 7 questions, higher values=better QoL.~Additional concerns 11 questions (higher values in 6 questions=better QoL; higher values in 5 questions=worse QoL)~The TOI is reported for each arm based on the average TOI score of each patient calculated across the outcome measure time frame. The higher the TOI, the better the QoL."|Patients will fill in FACT-O questionnaires at the following timepoints: baseline; Weeks 1, 3 and 6 of every chemotherapy cycle; at every follow up visit||||units on a scale||Standard Error|Mean
2706400|NCT01196741|Secondary|Median Duration of Response|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~Duration of Response will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||||||
2706401|NCT01196741|Secondary|Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria|Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||percentage of participants|||Number
2706402|NCT01196741|Secondary|Overall Survival||First saracatinib/placebo dose until death, assessed up to 36 months||||months||Full Range|Median
2706403|NCT01196741|Primary|6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria)|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||percentage of participants||90% Confidence Interval|Number
2706404|NCT01196533|Primary|Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.|"To validate the parameters with similar measures obtained with standard invasive techniques in hospitalized patients.~Methodology:~Eligible real time color signal obtained by the TensorTip shall be recorded simultaneously during the monitoring performed.~An algorithm shall be designed according to the blood color distribution to each parameter and a final test shall be recorded signals.~Statistical analysis for each parameter shall perform on the entire eligible recorded signals.~Determination of Accuracy:~Err = √(1/N ∑N (Ref(k)-NewDevice(k)) ^2 ) (k=1)~For each parameter a satisfactory result is considered when Err satisfies the industry requirement.~Results viewing Each parameter comparative study shall be presented on a (X,Y) plan versus a regression line where X - represents the results measured by TensorTip and Y - the reference results."|one year||||percentage of error|||Number
2706405|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Month 3||||units on a scale||Standard Error|Least Squares Mean
2706406|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 2||||units on a scale||Standard Error|Least Squares Mean
2706407|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 1||||units on a scale||Standard Error|Least Squares Mean
2706408|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 10||||units on a scale||Standard Error|Least Squares Mean
2706409|NCT01196442|Secondary|Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics|Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most|From day 1 to day 30||||doses||Standard Deviation|Mean
2706410|NCT01196442|Secondary|Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 1|Participants at Day 1|||units on a scale||Standard Error|Least Squares Mean
2706412|NCT01196429|Secondary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST1.1 is a multi-page paper, and response is defined in the protocol across multiple pages, so it is not practical to define response here.|Every other cycle for first 6 months; then every 3 months for two years; then every six months for the next three years; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tu|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2706413|NCT01196429|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and Treated Patients|||months||90% Confidence Interval|Median
2706414|NCT01196429|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 mths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising tumor mark|Eligible and Treated Patients|||months||90% Confidence Interval|Median
2706415|NCT01196429|Primary|Frequency and Severity of Toxicity|Grade 3 or higher adverse events were graded by CTC AE v4|Each cycle while on treatment|Eligible and Treated Patients|||participants|||Number
2706416|NCT01196429|Primary|Compare Progression-free Survival in Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer Patients in Patients in the U.S. and Worldwide (Outside of Japan) Versus Patients in Japan.|"Progression-free survival (PFS) was defined s the period from study entry until disease progression, death, or the last date of contact. Progression was based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Outcome measure data not reported because protocol stated If the combination is declared active (i.e. HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status. The combination was not declared active in either population."|Tumor scans were done every other cycle for the first 6 months;then every 3 mnths x2;then every 6 mnths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggesting progressive dx or rising serum tumor marker le|"The protocol stated if the combination is declared active (i.e., HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status. The combination was not declared active in either population."||||||
2706417|NCT01196429|Primary|Proportion of Patients Who Are Alive and Progression-free for at Least 12 Months After Study Entry in Patients With Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer in the Following Populations: Patients in the U.S./Worldwide and Japan|Progression of target lesions (TL) was a >=20% increase in the sum of the diameters of TL, taking as reference the smallest sum on study (including the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must demonstrate an absolute increase >=5 mm. Progression of non-target lesions (NTL) as defined as appearance of >=1 new lesions or unequivocal progression of existing NTL. Unequivocal progression should not normally trump target lesion status; it must be representative of overall disease status change, not a single lesion increase. Clear progression of only NTL is exceptional, but the opinion of the treating physician should prevail in such circumstances, and the progression status should be later confirmed by a review panel (or Principal Investigator). Progression of TL, unequivocal progression of NTL, or new lesions constitutes progression. This description is abbreviated; see the RECIST 1.1 manuscript for further details.|Tumor scans were done every other cycle for the first 6 months; then every 3 months x2; then every 6 months thereafter; and at any other time if clinically indicated or signs suggestive of progressive disease or rising levels; for up to 5 years.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2706418|NCT01196416|Secondary|Participants Evaluated for Toxicity|Number of patients with AE's as assessed by NCI CTCAE v. 4.0 Please see Adverse Events section for specifics.|Up to 30 days post-treatment||||Participants|||Count of Participants
2706419|NCT01196416|Secondary|Progression-free Survival (Phase II)|Progression-free survival curves will be generated using Kaplan-Meier methodology.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years||||months||Full Range|Median
2706420|NCT01196416|Secondary|Number of Participants With Presence or Absence of Markers of Notch Signalling Pathway Inhibition in Patient Tumors (Phase Ib)|The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test.|2 weeks||||Participants|||Count of Participants
2706421|NCT01196416|Secondary|Cycle 1 Mean Day 2 Trough/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)||At Day 2 of Cycle 1||||ng/mL||Standard Deviation|Mean
2706422|NCT01196416|Secondary|Cycle 1 C Max/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)||At Cycle 1||||ng/mL||Standard Deviation|Mean
2706423|NCT01196416|Secondary|Cycle 1 AUC/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)||Days 4 and 5||||hr·ng/mL||Standard Deviation|Mean
2706424|NCT01196416|Secondary|Participants' Change in Protein Levels|Participants' pre and post-treatment protein levels will be compared|Baseline up to 2 weeks||||Participants|||Count of Participants
2706425|NCT01196416|Primary|Maximum Tolerated Dose for RO4929097|based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)|21 days||||mg/day|||Number
2706426|NCT01196416|Primary|Overall Survival (Phase II)|Overall response rate (complete [CR] or partial response [PR]) according to RECIST version 1.1|Up to 2 years||||participants|||Number
2706427|NCT01196416|Primary|Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ|"based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)~Data is not yet available, as it's currently being analyzed."|21 days||||mg/m2|||Number
2707938|NCT01188369|Secondary|Peak Systolic Velocity (m/s)|Tissue Doppler measure of systolic function|96 hours after operation until 6 months after operation|||||||
2706428|NCT01196416|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years||||Participants|||Count of Participants
2706429|NCT01196377|Primary|%FEV1|% predicted forced expiratory volume in 1-second as a measure of airway obstruction|2 hours||||%-predicted||Full Range|Mean
2706430|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 14, 11pm|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Median
2706431|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 14, 7am|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Median
2706432|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 7, 11pm||||nmol/l||95% Confidence Interval|Median
2706433|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 7, 7am|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Mean
2706434|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 1, 11pm|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Median
2706435|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 1, 7am|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Median
2706436|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 0, 11pm|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Median
2706437|NCT01196117|Secondary|Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.|Day 0, 7am|A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night|||nmol/l||95% Confidence Interval|Median
2706438|NCT01196117|Primary|Epworth Sleepiness Score (ESS)|Epworth Sleepiness Score (ESS) is a scale to assess sleepiness during waking hours. The scale ranges from 0-24 with higher scores indicative of greater sleepiness.|Difference between Baseline(Day 0) and Average of Day 1,7,14.||||units on a scale||95% Confidence Interval|Median
2706439|NCT01196117|Primary|Salivary Cortisol Level|Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. Samples were collected at ~7am and ~11pm on each Day: 0, 1, 7 and 14 through a salivary swab.|Difference between Baseline(Day 0) and Average of Day 1,7,14.|We have made a best faith effort from a manuscript to determine the primary outcome measure; Salivary Cortisol Level; but access to the primary data has been lost and it additionally cannot be found in the manuscript. Despite all efforts to contact the PI/study team members, the statisticians and date are gone.||||||
2706440|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC|Baseline to Week 20|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
2706441|NCT01196104|Secondary|Week 20 (Follow-up) Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC|Week 20|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
2706442|NCT01196104|Secondary|Week 16 Change From Baseline Forced Vital Capacity|Week 16 Change from Baseline FVC|Baseline to Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
2706443|NCT01196104|Secondary|Week 16 Forced Vital Capacity|Week 16 FVC|Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
2706444|NCT01196104|Secondary|Baseline Forced Vital Capacity (FVC)|Baseline FVC|Baseline|Safety Population|||L||Standard Deviation|Mean
2706445|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1|Baseline to Week 20|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
2706446|NCT01196104|Secondary|Week 20 (Follow-up) Forced Expiratory Volume in 1 Second|Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment|Week 20 (Follow-up)|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
2706447|NCT01196104|Secondary|Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second|Week 16 Change from Baseline in FEV1|Baseline to Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
2706448|NCT01196104|Secondary|Week 16 Forced Expiratory Volume in 1 Second|Week 16 FEV1|Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
2706455|NCT01196104|Secondary|Severe Hypoglycemic Event Rate|"Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:~SMBG levels ≤ 36 mg/dL OR~There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures"|Baseline to Week 16|Safety Population|||Events / subject-month|||Number
2706456|NCT01196104|Secondary|Total Number of Cough Episodes|Total number of times patients coughed once, intermittently or continuously (inclusive)|Baseline to Week 16|Safety Population|||Cough episodes|||Number
2706457|NCT01196104|Secondary|Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706458|NCT01196104|Secondary|Changes in Body Weight at 16 Weeks|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706459|NCT01196104|Secondary|Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706460|NCT01196104|Secondary|Seven-point Glucose at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706461|NCT01196104|Secondary|Glycomark and Fructosamine Levels Measured Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706462|NCT01196104|Secondary|Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706463|NCT01196104|Secondary|Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706464|NCT01196104|Secondary|To Evaluate the Effect of Each Treatment on HbA1c|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
2706465|NCT01196104|Primary|Change in HbA1c (%) From Baseline to Week 16|Change from Baseline in glycated hemoglobin at Week 16|Baseline to Week 16|Safety Population, participants with data available at Baseline and Week 16|||Percentage of total hemoglobin||Standard Deviation|Least Squares Mean
2706466|NCT01196091|Secondary|Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline|"The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks.~The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology."|Baseline through 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.|||Participants|||Count of Participants
2706467|NCT01196091|Secondary|Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of participants|||Number
2706468|NCT01196091|Secondary|Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score|Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2706469|NCT01196091|Secondary|Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks|An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.|52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of participants|||Number
2706470|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint in PGA|Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||millimeters||Standard Deviation|Mean
2706488|NCT01196078|Secondary|Percentage of Participants With Disease Progression|Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population|||percentage of participants|||Number
2706471|NCT01196091|Secondary|Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares|"The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.~Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit."|Baseline through 52 weeks|Zero participants analyzed. Time first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares data was not collected for analysis.||||||
2706472|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores|The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and a non-missing result.|||units on a scale||Standard Deviation|Mean
2706473|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores|A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2706474|NCT01196091|Secondary|Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks|Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points.|52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues|||percentage of participants|||Number
2706475|NCT01196091|Secondary|Time to First Severe SLE Flare (SFI)|"The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.~Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1)."|Baseline through 52 weeks|Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis.||||||
2706476|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score|SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
2706477|NCT01196091|Secondary|Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues and a non-missing result at Week 52.|||international units||Standard Deviation|Mean
2706478|NCT01196091|Secondary|Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52|A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.|52 weeks|All randomized participants who received at least 1 dose of study drug, a baseline use of prednisone or equivalent >7.5 mg/day, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of partipants|||Number
2706479|NCT01196091|Primary|Percentage of Participants Achieving an SLE Responder Index Response at Week 52|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug and evaluable SLE scores, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of participants|||Number
2706500|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
2706480|NCT01196078|Secondary|Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2706481|NCT01196078|Secondary|Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2706482|NCT01196078|Secondary|Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change|The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2706483|NCT01196078|Secondary|Changes in Quality of Life as Measured by the FACT Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2706484|NCT01196078|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2706485|NCT01196078|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population|||months||95% Confidence Interval|Median
2706486|NCT01196078|Secondary|Overall Survival: Percentage of Participants With an Progressive Disease or Death|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population|||percentage of participants|||Number
2706487|NCT01196078|Secondary|Time to Disease Progression|Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population|||months||95% Confidence Interval|Median
2706569|NCT01195779|Secondary|Serum HI Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706489|NCT01196078|Secondary|Duration of Response Among Participants Who Achieved Either a CR or PR|Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.|Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up|ITT population; only participants with a response (CR or PR) were included in the analysis.|||months||95% Confidence Interval|Median
2706490|NCT01196078|Secondary|Percentage of Participants Achieving Disease Control|Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT Population|||percentage of participants|||Number
2706491|NCT01196078|Primary|Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)|CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT population|||percentage of participants|||Number
2706492|NCT01196052|Secondary|Disease-free Survival at Month 12|Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.|From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later|"Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.~Due to too few events, the analysis of disease-free survival was not performed."||||||
2706493|NCT01196052|Secondary|Percentage of Participants With a Pathological Complete Response|Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.|Day of surgery|Efficacy analysis population: All participants who enrolled in the neoadjuvant setting and received surgery, after completing 4 cycles of trastuzumab emtansine treatment.|||Percentage of participants||95% Confidence Interval|Number
2706494|NCT01196052|Secondary|Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay||From the start to the end of radiotherapy treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy and who had radiotherapy dose information reported were included in the analysis.|||Percentage of participants|||Number
2706495|NCT01196052|Secondary|Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment|Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.|||Percentage of participants|||Number
2706496|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent hormonal therapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent hormonal therapy were included in the analysis.|||Percentage of participants|||Number
2706497|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent radiotherapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy were included in the analysis.|||Percentage of participants|||Number
2706498|NCT01196052|Primary|Adverse Events, LVEF Function, and Deaths|The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF < 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.|||Percentage of participants|||Number
2706499|NCT01196052|Primary|Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment|A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of < 50%.|Baseline to 12 weeks after the start of trastuzumab emtansine treatment|Cardiac-safety evaluable population: All participants who received at least 1 dose of T-DM1 and met either of the following 2 criteria: (1) Had an echocardiogram/multiple-gated acquisition assessment by 12 weeks after the first dose of T-DM1 or (2) discontinued study treatment because of cardiac toxicity prior to completion of 4 cycles of T-DM1.|||Percentage of participants||95% Confidence Interval|Number
2706570|NCT01195779|Primary|Number of Subjects Reporting Fever of at Least Grade 2 or Higher|Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.|Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706501|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Day 28|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
2706502|NCT01196026|Secondary|Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest|"MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.~AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis."|During the entire study period (up to Month 6)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
2706503|NCT01196026|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Day 0-27) after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
2706504|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.|||days||Inter-Quartile Range|Median
2706505|NCT01196026|Secondary|Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.|||Participants|||Count of Participants
2706506|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.|||days||Inter-Quartile Range|Median
2706507|NCT01196026|Secondary|Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.|||Participants|||Count of Participants
2706508|NCT01196026|Secondary|Duration of Any Solicited Local Symptom|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.|During the 7 days (Days 0 - 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.|||days||Inter-Quartile Range|Median
2706509|NCT01196026|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.|During the 7 days (Day 0 - 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.|||Participants|||Count of Participants
2706510|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||Participants|||Count of Participants
2706511|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix|Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||Participants|||Count of Participants
2706571|NCT01195779|Primary|Geometric Mean Number of All-CD4 Cytokine Positive Cells|Geometric mean of the number of CD4 cytokine positive T cells per million T cells.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706512|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||Participants|||Count of Participants
2706513|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:28.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||Participants|||Count of Participants
2706514|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||titer||95% Confidence Interval|Geometric Mean
2706515|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as Geometric Mean Titers (GMTs).|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||titer||90% Confidence Interval|Geometric Mean
2706516|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||ratio||95% Confidence Interval|Geometric Mean
2706517|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||ratio||95% Confidence Interval|Geometric Mean
2706518|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||Participants|||Count of Participants
2706519|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.|||Participants|||Count of Participants
2706520|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||Participants|||Count of Participants
2706521|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains."|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||Participants|||Count of Participants
2706522|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||Participants|||Count of Participants
2706523|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.|||Participants|||Count of Participants
2706524|NCT01196026|Secondary|HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||titer||95% Confidence Interval|Geometric Mean
2706525|NCT01196026|Secondary|HI Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.|||titer||95% Confidence Interval|Mean
2706526|NCT01196026|Primary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||ratio||95% Confidence Interval|Geometric Mean
2706527|NCT01196026|Primary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||Participants|||Count of Participants
2706528|NCT01196026|Primary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||Participants|||Count of Participants
2706529|NCT01196026|Primary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||Participants|||Count of Participants
2706530|NCT01196026|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs).|Day 0 and 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||titer||95% Confidence Interval|Geometric Mean
2706531|NCT01195948|Secondary|Changes in High-speed Indocyanine Green Angiography (HS-ICG)||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
2706532|NCT01195948|Secondary|Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.|This outcome was not analyzed as no data was collected at Week 24.|Week 24|This outcome was not analyzed as no data was collected at Week 24.||||||
2706533|NCT01195948|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
2706534|NCT01195948|Secondary|Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
2706535|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||ETDRS letters||Full Range|Mean
2706536|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||ETDRS letters||Full Range|Mean
2706537|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 52|Twenty-five (25) participants completed Week 52. Three completed prior to Week 52 as a result of early study closure (1/group), two placebo participants and one 4 mg participant were lost to follow-up at Weeks 10, 44 and 28, respectively.|||participants|||Number
2706538|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
2706539|NCT01195948|Primary|The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.|"Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system.~The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation."|Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks||||weeks||Inter-Quartile Range|Median
2706540|NCT01195922|Primary|Percent (%) Change in Clinical and Laboratory Evaluations for Safety||Percent (%) change from Pre to Post treatement (~21 days)|Same sample loss during processing for phosphor and magnesium|||percentage change from baseline||Standard Deviation|Mean
2706541|NCT01195922|Primary|Percent (%) Changes in Tumor Size, Blood Flow, and Standardized Uptake Value||21 days post treatment with rapamycin|It was not possible to obtain appropriate CT scans or SUV measurement from all participants|||percentage change from baseline||Standard Deviation|Mean
2706542|NCT01195922|Primary|Percent (%) Change in Levels of pS6, pAKt473, and Ki-67||21 days post treatment with rapamycin|paraffin embedded formalin fixed tissues including head and neck cancer lesion were not available for 2 participants|||percentage of change from baseline||Standard Deviation|Mean
2706543|NCT01195883|Secondary|Number of Participants With Postoperative Acute Kidney Injury|Preoperative-to-postoperative change in AKIN stage|Hospitalization||||Participants|||Count of Participants
2706544|NCT01195883|Secondary|Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death|A composite of the primary outcome, and readmission and death.|Postoperative 30 days||||Participants|||Count of Participants
2706545|NCT01195883|Secondary|Number of Participants With Postoperative Morbidity (Minor Complications)|Any of the following minor complications: (1) unplanned ICU admission; (2) unplanned operation; (3) cardiac (ischemia/non-ventricular arrhythmia/hemodynamic disturbances); (4) pulmonary effusion; (5) deep venous thrombosis; (6) gastrointestinal (effusion/gut paralysis); (7) progressive renal insufficiency; (8) infection (superficial/fever/cystitis or urinary tract infection); and (9) transient neurological injury.|Postoperative 30-days||||Participants|||Count of Participants
2706546|NCT01195883|Primary|Number of Participants With Postoperative Morbidity (Major Complications)|Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding).|Postoperative 30-days||||Participants|||Count of Participants
2706547|NCT01195844|Primary|The Number of Deaths in Hospitalized Participants Enrolled in the Study|The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|Participants were not followed-up in the study; thus the number of deaths was not known.||||||
2706548|NCT01195844|Primary|The Duration of Hospitalization for Participants Enrolled in the Study|The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|From hospital admission to discharge|The population analyzed was all enrolled participants whether or not a fecal sample was obtained.|||days||Standard Deviation|Mean
2706549|NCT01195844|Primary|The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained|||Participants|||Number
2706550|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group.|1 year|The population analyzed was the 27 of 190 participants who had a fecal sample positive for rotavirus.|||participants|||Number
2706551|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers.|1 year|Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers|||percentage of participants||95% Confidence Interval|Number
2706572|NCT01195779|Primary|Serum Neutralizing Antibody Titers||at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706552|NCT01195844|Primary|The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported.|1 year|The population analyzed was children up to 5 years of age hospitalized for diarrhea. A total of 190 of the 230 participants had fecal samples analyzed; 27 of these had stool samples positive for rotavirus.|||Participants|||Number
2706553|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|"The population to be analyzed was all hospitalizations for any reason for children up to 5 years of age in the 4 hospital research centers~The number of total hospitalizations for children up to 5 years of age was not known; thus this outcome measure was not evaluated"||||||
2706554|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained|||participants|||Number
2706555|NCT01195831|Secondary|Evaluation of the Quality of Life||Baseline to weeks 2 and 4|||||||
2706556|NCT01195831|Secondary|Patients With Success (Patient's Itching Score=None) at Week 4||4 weeks|||||||
2706557|NCT01195831|Secondary|For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4||4 weeks|||||||
2706558|NCT01195831|Secondary|Patients With Success (Total Sign Score ≤1) at Week 4|"Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved Success."|4 weeks||||percentage of participants|||Number
2706559|NCT01195831|Secondary|"Patients With Controlled Disease in Term of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 4."|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|4 weeks||||percentage of participants|||Number
2706560|NCT01195831|Secondary|"Patients With Controlled Disease in Terms of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 2."|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|2 weeks||||percentage of participants|||Number
2706561|NCT01195831|Secondary|"Patients With Controlled Disease in Terms of Clear or Minimal According to Investigator's Global Assessment of Disease Severity at Week 2"|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease.|2 weeks||||percentage of participants|||Number
2706562|NCT01195831|Primary|"Patients With Controlled Disease in Terms of Clear or Minimal According to Investigator's Global Assessment of Disease Severity at Week 4."|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.|4 weeks||||percentage of parcipitants|||Number
2706563|NCT01195779|Secondary|Number of Subjects Reporting Serious Adverse Events|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 179||||Subjects|||Number
2706564|NCT01195779|Secondary|Number of Subjects Reporting Potential Immune-mediated Diseases|Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706565|NCT01195779|Secondary|Number of Subjects Reporting Adverse Events With Medically Attended Visits|A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706566|NCT01195779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 28 days (Day 0 to Day 27) after any vaccination||||Subjects|||Number
2706567|NCT01195779|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.|during a 7 day follow-up period (Day 0 to 6) after any vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2706568|NCT01195779|Secondary|Serum Neutralising Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2707939|NCT01188369|Secondary|Peak Systolic Velocity (m/s)|Tissue Doppler measure of systolic function|21 hours after operation until 96 hours after operation|||||||
2706574|NCT01195701|Secondary|FSFI Pain|The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
2706575|NCT01195701|Secondary|FSFI Satisfaction|The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
2706576|NCT01195701|Secondary|FSFI Orgasm|The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
2706577|NCT01195701|Secondary|FSFI Lubrication|The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
2706578|NCT01195701|Secondary|FSFI Arousal|The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
2706579|NCT01195701|Secondary|FSFI Desire|The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
2706580|NCT01195701|Secondary|Female Sexual Function Index (FSFI) Total Score|The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction.|baseline visit||||units on a scale||Standard Deviation|Mean
2706581|NCT01195701|Secondary|Free Androgen Index|Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)|Between day 1-14 (follicular phase) of menstrual cycle||||ratio||95% Confidence Interval|Number
2706582|NCT01195701|Secondary|Total Testosterone|Free & total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle||||ng/dL||Inter-Quartile Range|Median
2706583|NCT01195701|Secondary|Free Testosterone|Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle||||pg/mL||Inter-Quartile Range|Median
2706584|NCT01195701|Primary|Clitoral Measurements Using Pelvic MRI|All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.|Between day 1-14 (follicular phase) of menstrual cycle||||millimeters (mm)||Standard Deviation|Mean
2706585|NCT01195675|Other Pre-specified|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Drug administration until beginning of next sequence/end of trial, up to 48 days|Treated set (TS): All subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
2706586|NCT01195675|Other Pre-specified|Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings.|"The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.~Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms||Standard Deviation|Mean
2707940|NCT01188369|Secondary|Peak Systolic Velocity (m/s)|Tissue Doppler measure of systolic function|1 hour before operation until 21 hours after operation|||||||
2706587|NCT01195675|Other Pre-specified|Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing.|"The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.~Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms||Standard Deviation|Mean
2706588|NCT01195675|Primary|Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg.~Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Deviation|Mean
2706589|NCT01195675|Secondary|Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.~For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen.~Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
2706590|NCT01195675|Secondary|Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.~For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen.~Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
2706591|NCT01195675|Secondary|Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings~Note, the means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
2706592|NCT01195675|Secondary|Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg.~Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Deviation|Mean
2706593|NCT01195675|Secondary|Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg.~Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
2706594|NCT01195675|Primary|Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg.~Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
2706595|NCT01195662|Secondary|Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue|Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.|Baseline (Day 1), Week 12|N= All randomized participants who received double-blind medication and had non-missing Week (t) values. Week 12 includes participants with orthostatic hypotension during Week 12 visit window. Data after rescue included.|||Percent of Participants|||Number
2706596|NCT01195662|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue|12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.|Baseline, Week 12|N= All randomized participants who received double-blind medication. Data after rescue included.|||participants|||Number
2706597|NCT01195662|Secondary|Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue|Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.|Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days|N=All randomized participants who received at least 1 dose of study medication. n=number of participants treated with double blind study medication with at least one non-missing post-baseline value. Data after rescue included.|||participants|||Number
2706598|NCT01195662|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue|Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.|Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days|N=All randomized participants who received at least one dose of double-blind medication. n=all treated participants who had non-missing Baseline and on-study measurement. Data after rescue included.|||participants|||Number
2706599|NCT01195662|Secondary|Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue|Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.|Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event|Randomized participants who received double-blind study medication in the double-blind period.|||participants|||Number
2706600|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue was included.|||mg/dL||Standard Error|Mean
2706601|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)|Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement (Week 12 LOCF). Data after rescue excluded from analyses.|||mmHg||Standard Error|Mean
2706602|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants|Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses|||mmHg||Standard Error|Mean
2706642|NCT01195415|Primary|Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS|The median percentage of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated.|3 weeks|Of the 25 patients enrolled, only 22 were evaluable for the primary endpoint.|||percentage of CD44+/ CD24+/ ESA+ cells||Full Range|Median
2706603|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)|Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and Week 12 (LOCF) values. Data after rescue excluded from analyses.|||mmHg||Standard Error|Mean
2706604|NCT01195662|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue included.|||Percent of Hemoglobin||Standard Error|Mean
2706605|NCT01195662|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants|Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses|||mmHg||Standard Error|Mean
2706606|NCT01195636|Secondary|Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF)|"Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated.~This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF).~The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."|||units on a scale||95% Confidence Interval|Least Squares Mean
2706607|NCT01195636|Secondary|Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)|"Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed.~This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)).~The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."|||units on a scale||Standard Deviation|Mean
2706608|NCT01195636|Secondary|Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment||3 Weeks||||participants|||Number
2706609|NCT01195636|Secondary|Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||participants|||Number
2706610|NCT01195636|Secondary|Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||participants|||Number
2706678|NCT01195090|Secondary|Change in Fasting Triglycerides(TG)|TG change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
2706611|NCT01195636|Secondary|Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo|Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||participants|||Number
2706612|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 3|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||units on a scale||95% Confidence Interval|Least Squares Mean
2706613|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 2|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|2 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||units on a scale||95% Confidence Interval|Least Squares Mean
2706614|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 1|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|1 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||units on a scale||95% Confidence Interval|Least Squares Mean
2706615|NCT01195636|Primary|Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF).~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."|||units on a scale||95% Confidence Interval|Least Squares Mean
2706616|NCT01195623|Secondary|Recurrence Rate|number of recurrences in treatment arms but also nature of recurrences|7 years|The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ)|||legs|Participants||Number
2706617|NCT01195623|Primary|Rate of Re-do Surgery|number of reoperations (legs) in the two treatment arms|7 years mean|The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group|||legs|||Number
2706618|NCT01195597|Secondary|Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)|Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)|||number of participants|||Number
2706619|NCT01195597|Primary|Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)|Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)|||number of participants|||Number
2706620|NCT01195584|Secondary|Days of Hospitalization|Total time of hospitalization.|at hospital discharge|analysis per protocol|||Days||Standard Deviation|Mean
2706621|NCT01195584|Secondary|Drainage|Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.|at hospital discharge|analysis per protocol|||ml||Standard Deviation|Mean
2706622|NCT01195584|Secondary|Number of Spine Segments|Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.|peri operative|analysis per protocol|||spine segments||Standard Deviation|Mean
2706626|NCT01195545|Secondary|Pre and Post-operative Symptoms|"Dysphagia frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Dysphagia. The Dysphagia frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Dysphagia.~The Dysphagia VAS score was measured pre-operative and post-operative. The comparison of Dysphagia VAS score pre-operative and post-operative indicated that some participants experienced Improvement and others worsen."|Pre-surgery and 6 month follow up|Pre-surgery and a median of 6 month follow up (3-6months)|||Participants|||Count of Participants
2706627|NCT01195545|Secondary|Pre and Post-operative Symptoms|"Regurgitation frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Regurgitation. The Regurgitation frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Regurgitation.~The Regurgitation VAS score was measured pre-operative and post-operative. The comparison of Regurgitation VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement."|Pre-surgery and 6 month follow up|Pre-surgery an at median follow up of 6 month (3-6 month)|||Participants|||Count of Participants
2706628|NCT01195545|Secondary|Pre and Post-operative Symptoms|"Heartburn frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Heartburn. The Heartburn frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Heartburn.~The Heartburn VAS score was measured pre-operative and post-operative. The comparison of Heartburn VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement."|Pre-surgery and 6 month follow up|Pre-surgery and at a median follow up 6 months month (range 3 – 10 months)|||Participants|||Count of Participants
2706629|NCT01195545|Primary|Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series|Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.|6 months post procedure|6 months post-op follow up|||Participants|||Count of Participants
2706630|NCT01195467|Secondary|Change From Baseline of CNS Toxicity as Measured by Hospital Anxiety and Depression (HADS) Score (Baseline vs Week 12)|To assess the change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12)|baseline to week 12|||||||
2706631|NCT01195467|Secondary|Change From Baseline in Adherence From Baseline After 12 Weeks of Raltegravir as Measured by the Adherence Questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|To assess the change from baseline in adherence from baseline after 12 weeks of raltegravir as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|baseline to week 12|||||||
2706632|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Non-CNS Adverse Events After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 non-CNS adverse events after 12 weeks of raltegravir compared with baseline|baseline to week 12|||||||
2706633|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Laboratory Parameters (Excluding Lipids) After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 12 weeks of raltegravir compared with baseline|baseline to week 12|||||||
2706634|NCT01195467|Secondary|Change in Fasting Lipids (Total Cholesterol and Subfractions and Triglycerides) After 4 and 12 Weeks of Raltegravir|To assess the change in fasting lipids (total cholesterol and subfractions and triglycerides) after 4 and 12 weeks of raltegravir|week 4 to week 12|||||||
2706635|NCT01195467|Secondary|Proportion of Patients With Viral Load < 50 Copies/mL and <400 Copies/ml at Weeks 4 and 12 After Switching to Raltegravir|To assess the proportion of patients with viral load < 50 copies/mL and <400 copies/ml at weeks 4 and 12 after switching to raltegravir|week 4 to week 12|||||||
2706636|NCT01195467|Secondary|Change From Baseline to Week 12 in CD4+ Count After 12 Weeks of Raltegravir|Change from baseline to week 12 in CD4+ count after 12 weeks of raltegravir having switched from efavirenz-containing therapy|baseline to week 12|||||||
2706637|NCT01195467|Secondary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment|"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)"|baseline to week 12||||percentage of improvement in sleep score|||Number
2706638|NCT01195467|Primary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment|To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)|4 weeks||||percentage improvement in CNS score|||Number
2706639|NCT01195415|Secondary|Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0||Up to 4 weeks||||percentage of patients|||Number
2706640|NCT01195415|Secondary|Median Progression Free Survival|Median progression free survival was calculated for all treated patients. Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood's formula.|Up to 24 months||||months||95% Confidence Interval|Median
2706641|NCT01195415|Secondary|The Number of Participants With an Objective Best Response (CR + PR)|The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions.|Up to 4 weeks|All treated patients were evaluable.|||participants|||Number
2707941|NCT01188369|Secondary|Central Venous Pressure (mmHg)|Invasive measurement of pressure in the vena cava|4 hours after operation until 21 hours after operation|||||||
2706643|NCT01195363|Primary|Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.|The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.|Baseline visit to week 24|Per Protocol|||participants|||Number
2706644|NCT01195272|Secondary|Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments|Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant|Weeks 12, 24, and 36|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
2706645|NCT01195272|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||score on a scale||Standard Deviation|Mean
2706646|NCT01195272|Primary|Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation|Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of positive neutrophils||Standard Deviation|Mean
2706647|NCT01195272|Primary|Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake|S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of positive neutrophils||Standard Deviation|Mean
2706648|NCT01195272|Primary|Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||chemiluminescence units * hours||Standard Deviation|Mean
2706649|NCT01195272|Primary|Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||chemiluminescence units*hours||Standard Deviation|Mean
2706650|NCT01195272|Primary|Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
2706651|NCT01195272|Primary|Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
2706652|NCT01195272|Primary|Mean Fluorescence Intensity of CD63 on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
2706653|NCT01195272|Primary|Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls.|Visits 2, 3 and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
2706654|NCT01195272|Primary|Mean Fluorescence Intensity of CD18 on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed at each visit|||fluorescence intensity unit||Standard Deviation|Mean
2706655|NCT01195272|Primary|Mean Fluorescence Intensity of CD11b on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
2706656|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of cells staining positive||Standard Deviation|Mean
2706657|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|Intent-to-treat (ITT) Population: all participants in the Safety Population who provided follow-up data for neutrophils or at least 1 efficacy variable. n (number) equals (=) number of participants analyzed for the specified parameter at a given visit.|||percentage of cells staining positive||Standard Deviation|Mean
2706658|NCT01195116|Primary|Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU|It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.|Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average||||units on a scale||Standard Deviation|Mean
2706659|NCT01195103|Primary|Percentage of Participants Achieving Sedation Within 4 Minutes|"Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals lethargic response to name spoken in normal tone."|approximately 4 minutes after administration of first bolus of study drug||||percentage of participants|||Number
2706660|NCT01195090|Secondary|Baseline High-density Lipoprotein Cholesterol (HDL-C)|Baseline HDL-C|Baseline|Baseline HDL-C|||mg/dl||Standard Deviation|Mean
2706661|NCT01195090|Secondary|Baseline Low-density Lipoprotein Cholesterol (LDL-C)|Baseline LDL-C|Baseline|Baseline LDL-C|||mg/dl||Standard Deviation|Mean
2706662|NCT01195090|Secondary|Baseline Triglyceride (TG)|Baseline TG|Baseline|Baseline TG|||mg/dl||Standard Deviation|Mean
2706663|NCT01195090|Secondary|Baseline Total Cholesterol|Baseline Total cholesterol|Baseline|Baseline Total cholesterol|||mg/dl||Standard Deviation|Mean
2706664|NCT01195090|Secondary|Baseline Body Weight|Baseline body weight|Baseline|Baseline body weight|||kg||Standard Deviation|Mean
2706665|NCT01195090|Secondary|Baseline Alanine-aminotransferase (ALT)|Baseline alanine-aminotransferase|Baseline|Baseline alanine-aminotransferase|||IU/L||Standard Deviation|Mean
2706666|NCT01195090|Secondary|Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Baseline HOMA-IR|Baseline HOMA-IR|Baseline HOMA-IR|||HOMA-IR score||Standard Deviation|Mean
2706667|NCT01195090|Secondary|Baseline High Sensitive C-reactive Protein|Baseline high sensitive C-reactive Protein|baseline|Baseline high sensitive C-reactive Protein|||mg/dl||Standard Deviation|Mean
2706668|NCT01195090|Secondary|Baseline Fasting Plasma Glucose|Baseline fasting plasma glucose|baseline|Baseline fasting plasma glucose|||mg/dl||Standard Deviation|Mean
2706669|NCT01195090|Secondary|Percentages of Patients With Severe Hypoglycemia|Proportion of severe hypoglycemia after treatment|24 weeks|Proportion of severe ypoglycemia after treatment|||percentage|||Number
2706670|NCT01195090|Primary|The Percentages of Patient Achieving an A1C <7%|The percentages of patient achieving an A1C <7% at endpoint|24 weeks|The percentages of patient achieving an A1C <7% at endpoint|||percentage|||Number
2706671|NCT01195090|Primary|Baseline A1C|baseline A1C|Baseline|baseline Laboratory measurements|||percentage of Hb||Standard Deviation|Mean
2706672|NCT01195090|Secondary|Percentages of Patients With Nasopharyngitis|Proportion of Nasopharyngitis after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
2706673|NCT01195090|Secondary|Percentages of Patients With Gastrointestinal Adverse Events|Proportion of Gastrointestinal adverse events after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentge|||Number
2706674|NCT01195090|Secondary|Percentages of Patients With Edema|proportion of edema after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
2706675|NCT01195090|Secondary|Percentages of Patients With Mild to Moderate Hypoglycemia|Incidence of mild to moderate hypoglycemia after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
2706676|NCT01195090|Secondary|Change in Fasting Plasma Alanine-aminotransferase (ALT)|ALT change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||IU/L||Standard Error|Least Squares Mean
2706677|NCT01195090|Secondary|Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)|HDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
2706687|NCT01195025|Primary|Elimination Half Life for Different Fluids Alone or When Combined|Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.|420 minutes|All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers. Each experiment generated one elimination half-life (In experiment C one for acetated Ringer's and one for starch (HES 6%)).|||Minutes|Participants|Inter-Quartile Range|Median
2706688|NCT01195025|Secondary|Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.|The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) as well as Cystatin C, serum albumine and hemoglobin and how the concentration of these vary with the different dilutions of blood during and after infusion of a colloid and/or a crystalloid solution.|420 minutes||2015-05-31|05/2015||||
2706689|NCT01195025|Secondary|Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)|"Difference between true hemoglobin B-Hb and measured hemoglobin with pulseoximeter (SpHb)at the end of an infusion in relation to the initial measured values SpHb and B-Hb at the start of the infusion.~Relative difference (%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"|30 min|Only the pure experiments were included in this analysis. The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant.|||percentage of relative difference|Participants|Inter-Quartile Range|Median
2706690|NCT01195025|Secondary|Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids|"Pulse-oximeter based measurements compared with invasive hemoglobin measurements. All paired in the study.~Accuracy depending on which infusion is selected (Ringer's, Hydroxyethyl starch or a combination of both)."|420 min|The study was analysed per protocol and missing values were not replaced. All pairs of all collected data in one series of experiments. The number of analysed data points for each subject was in experiment A: 26, in experiment B: 32 and in experiment C: 42.|||percentage of relative difference|Participants|Inter-Quartile Range|Median
2706691|NCT01195025|Primary|Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.|"volume kinetics: mathematical calculation from hemoglobin variations during and after an infusion.~Degree of plasma dilution depending on which solution(s) and how much solution is/are given."|420 minutes|"All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers.~Each experiment generated one distribution volume. (In experiment C one for acetated Ringer's and one for Starch (HES 6%))."|||Litre||Inter-Quartile Range|Median
2706692|NCT01194999|Primary|Change in OAB Symptoms Post Pubovaginal Sling Operation|Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.|Baseline to final follow-up.|All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.|||participants|||Number
2706693|NCT01194973|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2706694|NCT01194973|Secondary|Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline sustained for at least two consecutive measurements obtained at least four weeks apart|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized for each parameter.|||Percentage of Participants||95% Confidence Interval|Number
2706695|NCT01194973|Secondary|Percentage of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706696|NCT01194973|Secondary|Percentage of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706697|NCT01194973|Secondary|Percentage of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
2706711|NCT01194856|Secondary|Compare Changes in Levels of Hs-CRP Between the Two Arms|To examine the effect of switching from EFV to ATV/r on highly sensitive C-reactive protein (hs-CRP) in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in hs (highly sensitive) - CRP levels between the EFV arm and the ATV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706698|NCT01194973|Secondary|Percentage of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
2706699|NCT01194973|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures Analysis of variance (ANOVA) model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2706700|NCT01194973|Secondary|Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706701|NCT01194973|Secondary|Percentage of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706702|NCT01194973|Secondary|Percentage of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706703|NCT01194973|Primary|Percentage of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
2706704|NCT01194973|Primary|Percentage of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
2706705|NCT01194908|Secondary|To Determine the Safety of Tamoxifen in Combination With Decitabine and LBH589||Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study.|No data were analyzed due to trial termination.||||||
2706706|NCT01194908|Primary|To Determine the Maximum Tolerated Dose of Decitabine and LBH589 Given in Combination in Patients With Metastatic or Locally Advanced Metastatic Breast Cancers||Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.|No data were analyzed due to trial termination.||||||
2706707|NCT01194869|Secondary|Clinical Response Rate (Complete Pathologic Response Rate After Surgery)|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|Up to 2 years after definitive surgery||||participants|||Number
2706708|NCT01194869|Secondary|Clinical Response Rate During Follow-up (Disease Recurrence)|Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.|Up to 2 years after definitive surgery||||participants|||Number
2706709|NCT01194869|Primary|Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|At the time of surgery, after 24 weeks of preoperative treatment||||participants|||Number
2706710|NCT01194856|Secondary|Correlate the Changes in DEXA-measured Fat Limb With Fat mtDNA, mtRNA and Fat Apoptosis|A secondary objective of this trial will be to correlate the changes in DEXA-measured limb fat with those of fat mtDNA, mtRNA levels and fat apoptosis|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706745|NCT01194570|Secondary|Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120||Baseline, Week 120|ITT population included all randomized participants in the study. Here, number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.|||percent change||95% Confidence Interval|Least Squares Mean
2706712|NCT01194856|Secondary|Comparing Glucose Metabolism (Fasting Insulin, QUIKI and HOMA-IR) Between the Two Arms|To examine the effect of switching from EFV to ATV/r on glucose metabolism in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting insulin, QUIKI and HOMA-IR between the EFV arm and the ATV/r arm|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706713|NCT01194856|Secondary|Comparing Fasting Lipid Levels Between the Two Arms|To examine the effect of switching from EFV to ATV/r on lipids in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting lipid levels between the EFV arm and ATV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706714|NCT01194856|Secondary|Compare Changes in Fat mtDNA, mtRNA and Fat Apoptosis Between the Two Arms|To examine the effect of switching from EFV to ATV/r on fat mtDNA, mtRNA, and fat apoptosis in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fat mtDNA, mt RNA levels and fat apoptosis between the EFV arm and ARV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706715|NCT01194856|Secondary|Compare Changes in CD4, HIV-1 RNA Levels and Adverse Events in Two Arms|To examine the effect of switching from EFV to ATV/r on safety in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in CD4 cell count, HIV-1 RNA levels, and adverse events between the EFV arm and the ATV/r arm|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706716|NCT01194856|Secondary|Compare Changes for DEXA-measured Limb Fat Between EFV and ATV/r Arms|To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, a secondary objective of this trial will be to compare changes over 96 weeks in DEXA-measured limb fat between the EFV arm and ARV/r.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706717|NCT01194856|Primary|Change in DEXA-measured Limb Fat Between the EFV and ATV/r Arms|To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, the primary objective of this trial will be to compare changes over 48 weeks in DEXA-measured limb fat between the EFV arm and ATV/r.|48 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
2706718|NCT01194830|Secondary|Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks||baseline, 24 weeks|Meal Tolerance Test, observed cases data set (MTT-OC) includes all randomized patients who participated in the MTT sub-study. Patients required to have both baseline and on-treatment results.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
2706719|NCT01194830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks||baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
2706720|NCT01194830|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.|||Participants|||Number
2706721|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.|||Participants|||Number
2706722|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.|||Participants|||Number
2706723|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2706724|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2706725|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2706726|NCT01194830|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2706727|NCT01194804|Secondary|Change From Baseline in Plasma Free Hemoglobin||52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)||||mg/dL||Standard Error|Mean
2706728|NCT01194804|Secondary|Change From Baseline in Number of Units of Packed RBCs Transfused|Baseline is defined as the number of units transfused in 3 months prior to baseline|52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)||||units||Standard Error|Mean
2706729|NCT01194804|Secondary|Change From Baseline in PNH Red Blood Cell (RBC) Count||52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)||||cellsx10^12/L||Standard Error|Mean
2706986|NCT01193283|Primary|Blood Counts and Adverse Event Profile After 6 Months of Treatment.|The safety endpoint will be toxicity profile after 6 months of treatment. The efficacy endpoint is complete response rate at 6 months, with complete response defined as blood counts no longer meeting the standard criteria for severe pancytopenia in severe aplastic anemia.|6 months||||participants|||Number
2706730|NCT01194804|Secondary|Change From Baseline in FACIT-Fatigue Scale Total Score|The FACIT-Fatigue scale, Version 4.0, is a collection of quality of life questionnaires pertaining to the management of fatigue symptoms due to a chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Patients score each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher score indicating better quality of life.|52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)||||units on a scale||Standard Error|Mean
2706731|NCT01194804|Primary|Change From Baseline in Lactate Dehydrogenase||52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)||||Units/Liter||Standard Error|Mean
2706732|NCT01194674|Secondary|Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline|"Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data."|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
2706733|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 12 Weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
2706734|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
2706735|NCT01194674|Secondary|Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
2706736|NCT01194674|Secondary|Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
2706737|NCT01194674|Primary|Number of Non-ocular Adverse Events|The number of adverse events that were not eye-related was calculated.|24 weeks||||Adverse Events|||Number
2706738|NCT01194674|Primary|Number of Ocular Adverse Events|The number of eye-related adverse events was calculated.|24 weeks||||Adverse Events|||Number
2706739|NCT01194674|Primary|Number of Severe Adverse Events||24 weeks||||Adverse Events|||Number
2706740|NCT01194674|Primary|Number of Adverse Events||24 weeks||||Adverse Events|||Number
2706741|NCT01194570|Secondary|Percentage of Participants With at Least One Adverse Event (AE)|AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.|From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks)|The safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
2706742|NCT01194570|Secondary|Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120|The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0−100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|From Baseline to Week 120|ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.|||units on a scale||95% Confidence Interval|Least Squares Mean
2706743|NCT01194570|Secondary|Percent Change in Total Brain Volume From Week 24 to Week 120||From Week 24 to Week 120|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint. Here, least square mean is indicating adjusted mean.|||percent change||95% Confidence Interval|Least Squares Mean
2706744|NCT01194570|Secondary|Percent Change From Baseline in Total Volume of T2 Lesions at Week 120||From Baseline to Week 120|ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.|||percent change||95% Confidence Interval|Least Squares Mean
2707942|NCT01188369|Secondary|Central Venous Pressure (mmHg)|Invasive measurement of pressure in the vena cava|End of operation until approx 4 hours after operation|||||||
2706746|NCT01194570|Secondary|Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period|The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.|Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint.|||weeks||Full Range|Median
2706747|NCT01194570|Primary|Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period|The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.|Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||weeks||Full Range|Median
2706748|NCT01194531|Primary|Implantation Rate|Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.|Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.|Patients who reached embryo transfer were included in this analysis.|||percentage of implantation per group|||Number
2706749|NCT01194479|Primary|Norepinephrine (pg/mL)|Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.|||pg/mL||Standard Error|Mean
2706750|NCT01194479|Primary|Epinephrine (pg/mL)|Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.|||pg/mL||Standard Error|Mean
2706751|NCT01194479|Secondary|Blood Glucose Levels (Average)|Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range. Presented is the average of the collected values.|Up to 120 minutes|Subjects are pooled across randomized conditions in their respective study arms and reported overall.|||mg/dL||Standard Deviation|Mean
2706752|NCT01194479|Primary|Glucagon (pg/mL)|Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages.|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.|||pg/mL||Standard Error|Mean
2706753|NCT01194466|Primary|Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)|"Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 no pain to 10 worst possible pain. Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure."|The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions|The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.|||change units on a VAS scale||Standard Deviation|Mean
2706754|NCT01194453|Secondary|Response Rate||6 weeks||||percentage|||Number
2706755|NCT01194453|Primary|Progression Free Survival (PFS)||36months||||day||95% Confidence Interval|Median
2706756|NCT01194440|Secondary|Number of Participants Who Discontinue or Change Aromatase Inhibitor (AI) Therapy||12 months||||Participants|||Count of Participants
2706757|NCT01194440|Secondary|AIMSS as Determined by Visual Analog Scale (VAS) Score|VAS is a visual measurement tool to assess AIMSS. It is a visual scale that ranges from 0 centimeters (cm) to 10cm. The VAS score ranges from zero (0cm) to 10 (10cm), with a higher score reflecting a greater frequency of AIMSS.|Baseline, 1 month, 3 months, 6 months, 12 months|Data was only collected for 58 participants at baseline, 52 participants at 1 month, 55 participants at 3 months, 50 participants at 6 months, and 45 participants at 12 months|||score on a scale||Full Range|Median
2706758|NCT01194440|Secondary|AIMSS as Determined by Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI score ranges from 0-3 with a higher score reflective of greater disability or increased incidence of AIMSS.|Baseline, 1 month, 3 months, 6 months, 12 months|Data was only collected in 58 participants at baseline, 52 participants at 1 month, 56 participants at 3 months, 51 participants at 6 months, and 45 participants at 12 months|||score on a scale||Full Range|Median
2706759|NCT01194440|Primary|Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)||12 months||||Participants|||Count of Participants
2707943|NCT01188369|Secondary|Central Venous Pressure (mmHg)|Invasive measurement of pressure in the vena cava|Start of operation until end of operation, approximately 3 hours|||||||
2706760|NCT01194427|Primary|Changes in Markers of Proliferation Prior to and After Study Drug Administration|To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.|Baseline and 14 days|Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.||||||
2706761|NCT01194414|Secondary|Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97||Week 97|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Here, 'n' indicates number of subjects in the safety population tested by screening assay at any time point.|||percentage of participants|||Number
2706762|NCT01194414|Secondary|Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97||Baseline, Week 97|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2706763|NCT01194414|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25||Baseline, Week 25|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2706764|NCT01194414|Secondary|Time to Maximum Serum Concentration (Tmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||hour (hr)||Full Range|Median
2706765|NCT01194414|Secondary|Maximum Serum Concentration (Cmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||mcg/mL||Standard Deviation|Mean
2706766|NCT01194414|Secondary|Minimum Serum Concentration (Cmin) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||micrgram/milliliter (mcg/mL)||Standard Deviation|Mean
2706767|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment||Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.|||μg*hr/mL||Standard Deviation|Mean
2706768|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion||Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
2706769|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug.|||percentage of participants|||Number
2706770|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.|Baseline, Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.|||percentage of participants|||Number
2706771|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28 score. Here, number of participants analyzed is the participants for whom parameter was collected.|||percentage of participants|||Number
2706772|NCT01194414|Secondary|Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97|ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.|Week 97|Re-Randomized Intent-to-Treat Population (ITT Population) included all participants who completed double blind period and were re-randomized at Week 24, received at least 1 dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.|||percentage of participants|||Number
2706773|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|24 Weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations.|||Percentage of participants|||Number
2706774|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.|Baseline, 24 Weeks|Participants from the Per Protocol Population (all randomized participants who received study drug and had no major protocol violations) with data available for analysis. No imputation of missing scores will be made other than for missing baseline scores, for which last score prior to defined protocol baseline time window will be carried forward.|||Percentage of participants|||Number
2706775|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.|Week 24|Participants from the Per Protocol Population (randomized participants who received study drug and had no major protocol violations) with data available for analysis. Missing SJC and TJC will be imputed using the last post-baseline value for the patient (LOCF). No imputation for missing ESR or patient’s global assessment of disease activity.|||Percentage of participants|||Number
2706776|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.|||Percentage of participants|||Number
2706777|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.|||Percentage of participants|||Number
2706778|NCT01194414|Primary|Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments||Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.|||percentage of participants|||Number
2706998|NCT01193257|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel||Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2706779|NCT01194414|Primary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.|||Percentage of participants||95% Confidence Interval|Number
2706780|NCT01194297|Secondary|Medically-attended Wheezing|Wheezing that triggers a visit for medical care|42 days|Total N|||participants|||Number
2706781|NCT01194297|Primary|Humoral Immunogenicity|Hemagglutinin specific antibody, as measured by hemagglutination inhibition|28-42 days|||||||
2706782|NCT01194258|Secondary|Mean Daily PPG Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (insulin lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Period 1 and Period 2 with evaluable PPG excursion data.|||mg/dL||Standard Deviation|Mean
2706783|NCT01194258|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both cohorts).|Baseline, Week 12 and Week 24|All participants who completed both Period 1 and Period 2 with evaluable body weight data.|||pounds||Standard Deviation|Mean
2706784|NCT01194258|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2.|||Events per participant per month|||Number
2706785|NCT01194258|Secondary|Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants in Treatment Period 1 or Treatment Period 2 who received at least 1 dose of study drug and had evaluable postprandial blood glucose data.|||Percentage of participants|||Number
2706786|NCT01194258|Secondary|Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring|Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable insulin dosing data.|||units of Insulin||Standard Deviation|Mean
2706787|NCT01194258|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period|Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable HbA1C data.|||percentage of HbA1C||Standard Deviation|Mean
2706809|NCT01194154|Secondary|Change From Baseline in Serum Cystatin C Concentration at Month 24|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.|||mg/L||Standard Deviation|Mean
2706788|NCT01194245|Secondary|Mean Daily Postprandial Glucose (PPG) Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2706789|NCT01194245|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data.|||pounds (lbs)||Standard Deviation|Mean
2706790|NCT01194245|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period|Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data.|||percentage of hemoglobin A1C||Standard Deviation|Mean
2706791|NCT01194245|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2.|||events per participant per month|||Number
2706792|NCT01194245|Secondary|Percentage of Participants Meeting Glucose Targets|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data.|||percentage of participants|||Number
2706793|NCT01194245|Secondary|Mean Daily Insulin Dose|Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data.|||units (U)||Standard Deviation|Mean
2706794|NCT01194219|Secondary|Number of Participants With a Psoriasis Flare or Rebound During the During the Apremilast-exposure Period Through Week 260|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 260|Safety population consisted of all participants who were randomized and received at least one dose of IP; apremilast participants as treated|||participants|||Number
2706795|NCT01194219|Secondary|Number of Participants With a Psoriasis Flare or Rebound During the Placebo-Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Weeks 0 to Week 16|Included all participants who were randomized and received at least one dose of Investigational Product (IP).|||participants|||Number
2706810|NCT01194154|Secondary|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24|UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Number of Participants Analyzed (N) = number of participants evaluable and available with valid data for this outcome measure. Here, n=number of participants evaluable for each category.|||mg/g||Standard Deviation|Mean
2706796|NCT01194219|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260|The Apremilast-exposure Period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. Adverse events that started after 28 days of initiating placebo and before resuming apremilast treatment in the Randomized Treatment Withdrawal Phase (Weeks 32 to 52) were excluded in the Apremilast-exposure Period. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 260; mean exposure to apremilast 30 mg BID during the Apremilast-exposure Period up to Week 260 was 97.83 weeks|The apremilast subjects as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||participants|||Number
2706797|NCT01194219|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; mean duration of exposure was 14.8 weeks and 15.0 weeks for subjects randomized to placebo and apremilast respectively.|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
2706798|NCT01194219|Secondary|Kaplan Meier Estimate of Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment where loss of PASI-75 was observed (event); or the time between the re-randomization date and the date of the last PASI assessment in the Weeks 32-52 interval prior to addition of protocol-prohibited medication/therapy, or resumption of APR 30 BID, or discontinuation, or Week 52 if no loss (censored).|Week 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or apremilast 30mg BID at Week 32.|||Weeks||95% Confidence Interval|Median
2706799|NCT01194219|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline|PASI-75 response was the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome Measure #1 for further description. sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See OCM #2 for further description.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
2706800|NCT01194219|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
2706801|NCT01194219|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included|||units on a scale||Standard Error|Least Squares Mean
2706802|NCT01194219|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
2706803|NCT01194219|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|A participant was classified as having at least a 50% improvement in PASI score from baseline, which was equivalent to a percent change from baseline ranging from −100% to −50%. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||Percentage of Participants|||Number
2706804|NCT01194219|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing. PASI score percent change from baseline was calculated as 100* (visit score - baseline score)/baseline score (%).|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included .|||percent change||Standard Error|Least Squares Mean
2706805|NCT01194219|Secondary|Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA - baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
2706806|NCT01194219|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator factored in areas that have already been cleared (ie, have scores of 0) and did not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
2706807|NCT01194219|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
2706808|NCT01194154|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|24 months|The Safety Analysis Set (SAF) included all participants who received at least one dose of study medication. Analysis for SAF was performed according to the study medication actually received (as treated population). Number of participants analyzed=participants evaluable for this measure.|||percentage of participants|||Number
2706811|NCT01194154|Secondary|Change From Baseline in Serum Creatinine Concentration at Month 24|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.|||mcmol/L||Standard Deviation|Mean
2706812|NCT01194154|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24|Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.|||mL/min||Standard Deviation|Mean
2706813|NCT01194154|Secondary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)|The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 141 x min (SerumCr/k; 1)^a x max(SerumCr/k; 1)^(-1.209) x 0.993^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m^2 / Year) is defined as -365.25 x Beta, where Beta is the slope parameter derived for each participant separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.|||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
2706814|NCT01194154|Primary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)|The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m^2) = 175 x Serum Cr^-1.154 x age^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m^2 / Year) is defined as -365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.|||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
2706815|NCT01194089|Secondary|Numeric Pain Score|Upon arrival in the PACU and at least every 30 minutes thereafter while in the PACU, the subject was asked to report pain using a numerical pain score for current pain at rest from 0 (representing no pain) to 10 (representing the worst imaginable pain).|on admission, 30 minutes, 60 minutes, at discharge|Not all participants completed the pain scale at every time point. The participants analyzed per arm (nicotine, normal) at each time point were: on admission (40, 45); 30 minutes (40, 47); 60 minutes (34, 40); at discharge (39, 44),|||units on a scale||Inter-Quartile Range|Median
2706816|NCT01194089|Secondary|Number of Participants Who Needed to Use Antiemetic Medication in the PACU|Rescue antiemetic therapy was 0.625 mg droperidol. Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.|24 hours postoperatively.||||participants|||Number
2706817|NCT01194089|Primary|Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively|Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.|During PACU stay (approximately 94 minutes after operation), 24 hours after operation||||mg||Inter-Quartile Range|Median
2706818|NCT01193920|Secondary|Number of Infants Reporting Serious Adverse Events|Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events|one year after birth||||Number of subjects|||Number
2706819|NCT01193920|Secondary|Antibody GMC Per Serotype at Different Time Points in Infants|Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.|Day 4, day 43 and day 91 after birth|Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames|||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
2706820|NCT01193920|Secondary|Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events|Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.|From day 1 to one year after delivery|Safety set, solicited and unsolicited reactogenicity, maternal subjects|||participants|||Number
2706821|NCT01193920|Secondary|Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events|Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.|Day 61|Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects|||participants|||Number
2706822|NCT01193920|Secondary|Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination|Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects|||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
2706850|NCT01193842|Secondary|Changes in Epstein-Barr Virus (EBV) Viral Load|Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.|Baseline up to 12 months|||||||
2706823|NCT01193920|Secondary|The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.|The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.|||percentage of subjects||95% Confidence Interval|Number
2706824|NCT01193920|Secondary|Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination|Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.|day 31|FAS, secondary, maternal subjects, day 31|||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
2706825|NCT01193920|Primary|Antibody GMC in Maternal Subjects at Day of Delivery|Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.|Day of delivery|FAS primary, maternal subjects|||Concentration (μg/mL)||95% Confidence Interval|Geometric Mean
2706826|NCT01193920|Primary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day of delivery|FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery|||percentage of subjects||95% Confidence Interval|Number
2706827|NCT01193920|Secondary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 31, one month after vaccination|FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31|||percentage of subjects||95% Confidence Interval|Number
2706828|NCT01193920|Primary|Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.|Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .|Day 61, one month after the second vaccination|FAS - primary, non-pregnant subjects|||concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
2706829|NCT01193920|Primary|The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.|The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 61, one month after the second vaccination|Full Analysis Set (FAS) – primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61|||percentage of subjects||95% Confidence Interval|Number
2706830|NCT01193907|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 28 days after vaccination||||percentage of subjects||95% Confidence Interval|Number
2706831|NCT01193907|Primary|Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)||At 28 days after vaccination||||GMC||95% Confidence Interval|Mean
2706832|NCT01193907|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination||||participants|||Number
2706833|NCT01193907|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue|During the 7-day period after vaccination||||participants|||Number
2706834|NCT01193868|Secondary|Progression-free Survival|Time from initiation of study drug until death, progression of tumor, or for worsening of tumor that did not meet RECIST 1.1 criteria but that did require discontinuation of therapy, assessed up to 5 years|Baseline up to 5 years|Study terminated early. Analysis not performed due to small numbers.||||||
2706835|NCT01193868|Secondary|Correlation of Tumor Shrinkage/Response With Biomarker Expression|Correlate percent change in tumor size at 6 weeks (or at time off study, if therapy is stopped earlier due to tumor progression) with tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers; Tumor % shrinkage with RO4929097 will correlate with pre-therapy tumor expression of Notch pathway members, with expression of stem cell markers, and with changes in these over the first cycle of therapy.|6 weeks|Study terminated early. Analysis not performed due to small numbers.||||||
2706836|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Tumor Progression|Tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers used in comparison to tumor progression; and progression evaluated in using international criteria proposed by revised RECIST guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests.|Up to 3 months|Study terminated early with low accrual leading to insufficient data for analysis.||||||
2706837|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Response by RECIST Criteria|Wilcoxon rank sum tests will be used.|Up to day 3|Study terminated early. Analysis not performed due to small numbers.||||||
2706851|NCT01193842|Secondary|Changes in Absolute CD4 Cell Counts (Phase I)|Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.|Baseline up to 12 months|Eligible participants who completed at least 1 cycle of treatment with evaluable data.|||cell/mm^3||Inter-Quartile Range|Median
2707944|NCT01188369|Secondary|Central Venous Pressure (mmHg)|Invasive measurement of pressure in the vena cava|1 hour before operation until start of operation|||||||
2706838|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Epidermal Growth Factor Receptor (EGFR) Activating Mutations|Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Sum Test). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.||||||
2706839|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With Versus Without a Particular Host Genotype Polymorphism|Wilcoxon rank sum tests will be used. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests).|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.||||||
2706840|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in This Population vs Tumor Bank Population|For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.||||||
2706841|NCT01193868|Primary|Percentage of Tumor Shrinkage as a Continuous Variable|Response is reported as a continuous variable, as % change in tumor size from baseline. Pearson and Spearman correlation coefficients will be used. Reported with 95% two-sided confidence intervals.|6 weeks|Study terminated early with low accrual leading to insufficient data for analysis.||||||
2706842|NCT01193868|Primary|Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with response per RECIST version 1.1: Complete Response (CR):Disappearance all target lesions. Any pathological lymph nodes with reduction in short axis to <10 mm. Partial Response (PR): At least 30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): At least 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must demonstrate an absolute increase of at least 5 mm. (Note: appearance of 1 or more new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Best response recorded from treatment start until disease progression/recurrence (reference for progressive disease the smallest measurements recorded since treatment started).|Response evaluation every 6 weeks (in addition to baseline scan, confirmatory scans approximately 6-7 (not less than 4) weeks following initial documentation of objective response). Expected follow up to 5 years, actual study period 9/2010 to 4/2014.|Only those participants who have measurable disease present at baseline and received at least one dose of study medication considered evaluable for response with their response classified according to the RECIST definitions stated. Participants who exhibit objective disease progression prior to the end of cycle 1 also considered evaluable.|||percentage of participants|||Number
2706843|NCT01193842|Secondary|Tumor Response (Phase I)|The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease|Up to 2 years post treatment|Eligible participants who completed at least 1 cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
2706844|NCT01193842|Secondary|Pharmacokinetic Clearance (Phase I)|Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.|24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion|Phase I participants with evaluable pharmacokinetic data|||Liter/hour||Standard Deviation|Mean
2706845|NCT01193842|Secondary|Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)|Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.|Baseline up to 12 months|Eligible participants who returned for follow-up with evaluable data.|||copies per milliliter||Inter-Quartile Range|Median
2706846|NCT01193842|Secondary|Overall Survival (OS) (Phase II)|The percentage of participants surviving one year after starting treatment.|1 year|Eligible randomized participants.|||percentage of participants||95% Confidence Interval|Number
2706847|NCT01193842|Secondary|Event-free Survival (EFS) (Phase II)|The percentage of participants surviving without events (relapse or death) one year after starting treatment.|1 year|Eligible randomized participants.|||percentage of participants||95% Confidence Interval|Number
2706848|NCT01193842|Secondary|Changes in Human Immunodeficiency Virus (HIV) Viral Load|Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.|Baseline up to 12 months|Phase II participants who returned for follow-up with evaluable data.|||copies per milliliter||Inter-Quartile Range|Median
2706849|NCT01193842|Secondary|Changes in Human Herpes Virus (HHV)-8 Viral Load|Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.|Baseline up to 12 months|||||||
2706853|NCT01193842|Primary|Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)|Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.|21 days|Eligible Phase I Arm A (VR-DA-EPOCH) participants who completed at least 1 cycle of treatment. This arm includes participants treated at 300 mg once a day (n=6) or 400 mg once a day (n=6) of Vorinostat for days 1-5.|||Mg per day of Vorinostat|||Number
2706854|NCT01193842|Primary|Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)|The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.|Up to 5 years|Eligible randomized participants|||percentage of participants|||Number
2706855|NCT01193842|Primary|Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)|Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.|Up to 6 months|Reviewed responses from participants who completed at least one cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
2706856|NCT01193686|Secondary|General Anger Level|5-item scale developed for this study. Assesses level of perceived experienced anger in the past month. Possible scores range from 5-35 with higher scores indicating greater levels of anger.|Post- Participation|This measure was only administered to Recipients of Peer Visits.|||units on a scale||Full Range|Mean
2706857|NCT01193686|Secondary|Patient Activation Measure|Measures participante self-efficacy, knowledge of and engagement in health care. Possible scores range from 13-52 with higher scores indicating greater efficacy/knowledge/engagement.|Post- Participation|This measure was only administered to Recipients of Peer Visitation.|||units on a scale||Full Range|Mean
2706858|NCT01193686|Secondary|Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)|Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.|Upon study completion.||||units on a scale||Full Range|Mean
2706859|NCT01193686|Secondary|Patient Health Questionnaire-9 (Depression Screen)|9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.|Upon completion of visits.||||units on a scale||Full Range|Mean
2706860|NCT01193686|Primary|Post Traumatic Growth Inventory|Administered only to Peer Visitors, possible range 0-105, with higher scores indicating greater post-traumatic growth. Post-traumatic growth includes emotional changes such as noticing a stronger sense of self, deepened relationships, increased sense of gratitude or appreciation for life, increased spirituality.|Upon completion of study requirements (i.e., visits)|This measure was only administered to Veteran Peer Visitors.|||units on a scale||Full Range|Mean
2706861|NCT01193660|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant|The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.|6 months||||participants|||Number
2706862|NCT01193660|Secondary|Changes in Hand Function|QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706863|NCT01193660|Secondary|Changes in Muscle Strength|Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706864|NCT01193660|Secondary|Changes in Functional Independence in Daily Activities|WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706903|NCT01193608|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706865|NCT01193660|Primary|Changes in Standardized Gross Motor Function|GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706866|NCT01193660|Secondary|Changes in Functional Performance in Daily Activities|Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.|Baseline -1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706867|NCT01193660|Secondary|Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism|"18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE."|Baseline - 2 weeks|Intention to treat|||units on a scale|||Number
2706868|NCT01193660|Secondary|Changes in Brain MRI|Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.|Baseline - 6 months||||units on a scale||Standard Error|Mean
2706869|NCT01193660|Secondary|Changes in Motor Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706870|NCT01193660|Secondary|Changes in Cognitive Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706871|NCT01193660|Primary|Changes in Motor Performance|GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
2706872|NCT01193608|Other Pre-specified|Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for t1/2. No participants had available data for t1/2 in AAB-003 8 mg/kg and Placebo Groups.|||Day||Standard Deviation|Mean
2706873|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706874|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUCinf. No participants had available data for AUCinf in AAB-003 8 mg/kg and Placebo Groups.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706875|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUClast.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706876|NCT01193608|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.|||Hours||Full Range|Median
2706877|NCT01193608|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication and have at least one postdose pharmacodynamic (PD) parameter assessment. n = number of evaluable participants at the corresponding timeframe.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2706878|NCT01193608|Other Pre-specified|CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
2706879|NCT01193608|Other Pre-specified|Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
2706880|NCT01193608|Other Pre-specified|CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
2706881|NCT01193608|Other Pre-specified|Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
2706882|NCT01193608|Other Pre-specified|CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
2706883|NCT01193608|Other Pre-specified|Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
2706884|NCT01193608|Other Pre-specified|CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2706885|NCT01193608|Other Pre-specified|Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2706886|NCT01193608|Other Pre-specified|Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32|Participants enrolled in the 2, 4 and 8 mg/kg cohorts participated in an optional CSF collection. Participants enrolled in the maximum tolerated dose (MTD) cohort were mandatorily collected for CSF.|Week 32 or Early Withdrawal|All randomized and treated participants in the 2, 4 and 8 mg/kg cohorts who consented to the collection of CSF samples.|||nanogram/millliter (ng/mL)||Standard Deviation|Mean
2706887|NCT01193608|Other Pre-specified|Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39|The MMSE is a brief 30-point questionnaire test that is used to assess cognition. It is commonly used to screen for dementia. In the time span of about 10 min, it samples various functions, including arithmetic, memory and orientation. Scores range from 0 to 30 (higher scores indicate less impairment) and participants with scores of 16 to 26 were eligible.|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
2706888|NCT01193608|Other Pre-specified|Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39|The CDR scale is a clinician-rated dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories - memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is based on discussions between the clinician with the participant and caregiver using a structured format. A global CDR score is established by clinical scoring rules with values of 0 (no dementia), 0.5 (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). A more quantitative version of the CDR scale is obtained by summing up the ratings in each of the 6 categories to provide the (CDR-SB). The CDR-SB scale ranges from 0 to 18 where higher score indicates severe dementia.|Baseline, Weeks 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
2706889|NCT01193608|Other Pre-specified|Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39|The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in participants with Alzheimer's disease (AD) and other dementias. Twelve (12) behavioral areas are assessed in the NPI - delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories as reported by the caregiver. A separate caregiver distress score may also be included. The NPI ranges from 0 to 144 (higher scores indicate greater psychopathology).|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
2706890|NCT01193608|Other Pre-specified|Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39|The DAD is a functional assessment based on an interview with the caregiver that takes approximately 20 min to administer and it is comprised of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. The DAD is scored from 0 to 100 (higher scores indicate better functioning).|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
2706891|NCT01193608|Other Pre-specified|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39|The ADAS-cog 70 Point is a structured scale (approximately 40 min to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis. This study used the 11-item cognitive subscale of the ADAS-Cog with scores ranging from 0 to 70 points; higher scores indicated greater cognitive impairment.|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
2706892|NCT01193608|Other Pre-specified|Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum|Human serum anti-drug antibodies (ADA) samples were analyzed for the presence or absence of anti-AAB-003 antibodies by enzyme-linked immunosorbent assay (ELISA) method|Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal|All participants who received an infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Participants|||Number
2706893|NCT01193608|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria|Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.|Baseline, Weeks 1,13,16,26,39 or Early Withdrawal|Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).|||Participants|||Number
2706894|NCT01193608|Primary|Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit|VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.|Day 1, Week 13, and Week 26|Safety Analysis Set included all participants who received an infusion of study medication, including partial infusions. n = number of evaluable participants at the corresponding timeframe.|||Participants|||Number
2706895|NCT01193608|Primary|Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding|Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.|Baseline up to Week 32.|Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).|||Participants|||Number
2706896|NCT01193608|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Baseline up to Week 39 or Early Withdrawal|Safety Analysis Set included all participants who received at least one infusion of study medication (including partial infusions).|||Participants|||Number
2706897|NCT01193608|Primary|Serum Decay Half-Life (t1/2) for AAB-003 at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||Days||Standard Deviation|Mean
2706898|NCT01193608|Primary|Serum Decay Half-Life (t1/2) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||Days||Standard Deviation|Mean
2706899|NCT01193608|Primary|Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2706900|NCT01193608|Primary|Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2706901|NCT01193608|Primary|Systemic Clearance (CL) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2706902|NCT01193608|Primary|Systemic Clearance (CL) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||milliliter/hour/kilogram (mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
2706904|NCT01193608|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706905|NCT01193608|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706906|NCT01193608|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2706907|NCT01193608|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||Hours (hr)||Full Range|Median
2706908|NCT01193608|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.|||Hours (hr)||Full Range|Median
2706909|NCT01193608|Primary|Average Concentration (Cavg) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2706910|NCT01193608|Primary|Average Concentration (Cavg) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2706911|NCT01193608|Primary|Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2706912|NCT01193608|Primary|Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Pharmacokinetic (PK) Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2706913|NCT01193608|Primary|Number of Participants With Abnormal Neurological Examination Findings|The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.|Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). n = number of evaluable participants at the corresponding time point.|||Participants|||Number
2706914|NCT01193608|Primary|Number of Participants With Abnormal Physical Examination Findings||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A full physical examination consisted of abdomen, genitourinary, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal, general, skin, extremities, head, ears, eyes, nose, throat and thyroid.|||Participants|||Number
2706915|NCT01193608|Primary|Number of Participants With Vital Signs of Potential Clinical Concern|Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.|Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions).|||Participants|||Number
2706916|NCT01193608|Primary|Number of Participants With Laboratory Abnormalities||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).|||Participants|||Number
2706917|NCT01193608|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A TEAE was defined as an untoward medical occurrence reported by the participant or investigator following administration of at least one dose of AAB-003.|||Participants|||Number
2706938|NCT01193348|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2706918|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
2706919|NCT01193582|Secondary|Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.|Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2706920|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
2706921|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3|Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2706922|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
2706923|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2|Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2706924|NCT01193582|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
2706925|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1|Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2706999|NCT01193257|Secondary|Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings||Cycle 59 Day 58|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2706926|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group|Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|Baseline|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2706927|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar|Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after last dose in each group|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2706928|NCT01193556|Secondary|Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level||1-2 weeks post-operatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2706929|NCT01193556|Primary|Post-operative Pain|The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.|10 days immediately following surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2706930|NCT01193530|Primary|Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center|"Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks. The PSQI is a validated tool for insomnia, an effective instrument for measuring the quality and patterns of sleep using a 19-item questionnaire. It differentiates poor from good sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The addition of all scores permits the analysis of the participant's overall sleep experience. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance."|Baseline and Day 14|Due to low enrollment and participation data was not collected for analysis.||||||
2706931|NCT01193517|Secondary|Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)|Per Response Evaluation Criteria in solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by CT or MRI: Partial Response (PR), >= 30%decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither PD nor PR, the sum of the longest diameters no change or increase by <20% from baseline or from nadir (smallest sum on treatment); Progressive Disease (PD), the sum of the longest diameters increases by>= 20% from nadir (smallest sum on treatment). For non-target lesions assessed by CT or MRI: Stable Disease (SD), Persistence of >=1 non-target lesion; Progressive Disease (PD), Enlargement of non-target lesions and/or appearance of new lesions.|After 9 weeks (three, 21 day cycles)||||Participants|||Count of Participants
2706932|NCT01193517|Primary|Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)|Dose just below the one at which ≥ 1/3 of subjects experience a dose limiting toxicity (DLT) considered the MTD.|Up to 3 weeks from the first dose||||mg/m^2|||Number
2706933|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort ≥40kg) N=5||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.|||micrograms/mL||Standard Deviation|Mean
2706934|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 30 - <40kg) N=1||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. N=0 in the maintenance phase because the patient changed to ≥40kg body weight category|||micrograms/mL||Standard Deviation|Mean
2706935|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 20 - <30kg)||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mL||Standard Deviation|Mean
2706936|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 10 - <20kg) N=7||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mL||Standard Deviation|Mean
2706937|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 5 - <10kg) N=3||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mL||Standard Deviation|Mean
2706939|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with eGFR Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706940|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706941|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706942|NCT01193348|Secondary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
2706943|NCT01193348|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2706944|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706945|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706946|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through 26 weeks of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
2706947|NCT01193348|Primary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
2706948|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2707012|NCT01193244|Secondary|Time to Docetaxel Chemotherapy|Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events.|Baseline until start of docetaxel chemotherapy (up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2706949|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2706950|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2706951|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
2706952|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
2706953|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||titer||95% Confidence Interval|Geometric Mean
2706954|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||titer||95% Confidence Interval|Geometric Mean
2706955|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
2706956|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|Before the toddler dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
2707052|NCT01193127|Secondary|Ocular Pain VAS Score After Day 0|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.|43 days|Subjects with data at time point.|||mm||Standard Deviation|Mean
2706957|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
2706958|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706959|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706960|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706961|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706962|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706963|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2707053|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 30|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|30 days|Subjects with data at time point.|||cells||Standard Deviation|Mean
2706964|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706965|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706966|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706967|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2706968|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2706969|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2706970|NCT01193335|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose|GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.|Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
2707054|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 14|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|14 days|Subjects with data at time point.|||cells||Standard Deviation|Mean
2706971|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1-year follow-up after toddler dose to 2-year follow-up after toddler dose|Safety population for 2-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.|||percentage of participants|||Number
2706972|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 month after toddler dose up to 1-year follow-up|Safety population for 1-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.|||percentage of participants|||Number
2706973|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Toddler dose up to 1 Month after toddler dose|Safety population for toddler dose included all participants who received 13vPnC toddler dose.|||percentage of participants|||Number
2706974|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 Month after Dose 3 of the infant series up to toddler dose|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.|||percentage of participants|||Number
2706975|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Dose 1 up to 1 month after Dose 3 (infant series)|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.|||percentage of participants|||Number
2706976|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
2706977|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
2706985|NCT01193335|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2706978|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
2706979|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received 13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
2706980|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2706981|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2706982|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2706983|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
2706984|NCT01193335|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after the infant series|Evaluable infant immunogenicity population. Here ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2706987|NCT01193257|Secondary|Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12|The global health status or quality of life (QOL) was measured as the HRQOL response rate at 12 weeks using the 2-item global health status index of the european organization for research and treatment of cancer-quality of life questionnaire-C30 (EORTC QLQ-C30) instrument. HRQOL response was defined as a 17-point increase from the baseline assessment on the QOL index, after the score had been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional, and social), 1 global health status, 3 symptom scales (fatigue, pain, nausea/vomiting) and 6 single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score representing better level of functioning or greater degree of symptoms.|Week 12|ITT population included all participants who were randomized.|||percentage of participants|||Number
2706988|NCT01193257|Secondary|Number of Participants With Best Pain Response|Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a >=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)|ITT population included all participants who were randomized.|||participants|||Number
2706989|NCT01193257|Secondary|Time to Pain Response|Time to pain response was defined as the time from randomization until first pain response. Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A >= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2706990|NCT01193257|Secondary|Time to Pain Progression|Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >= 4 with a >= 2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >= 4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <= 3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use.|Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2706991|NCT01193257|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (CR) was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)|Response per RECIST-evaluable population was defined as a subset of participants who had measurable disease by RECIST 1.1 at baseline.|||percentage of participants|||Number
2706992|NCT01193257|Secondary|Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)|A favorable CTC count was defined as less than (<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as >=5 counts/7.5 mL in whole blood.|Baseline and EOT (Cycle 59 Day 58)|ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.|||participants|||Number
2706993|NCT01193257|Secondary|Time to PSA Progression|Time to PSA progression was defined as time from randomization to a PSA increase of 25% and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, above the baseline PSA.|Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2706994|NCT01193257|Secondary|Best PSA Response at Any Time During the Study|The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, and 25|Best PSA response was not evaluated due to change in planned analysis.||||||
2706995|NCT01193257|Secondary|Percentage of Participants Achieving PSA90 Response at Any Time During the Study|The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.|Cycle: 7, 10, 13, 16, 19, 22, and 25|ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.|||percentage of participants|||Number
2706996|NCT01193257|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12|The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.|Week 12|ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.|||percentage of participants|||Number
2706997|NCT01193257|Secondary|Percentage of Participants Achieving PSA50 Response at Any Time During the Study|The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, and 25|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.|||participants|||Number
2707000|NCT01193257|Secondary|Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status|ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.|Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707001|NCT01193257|Secondary|Number of Participants With TEAEs Related to Weight||Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707002|NCT01193257|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707003|NCT01193257|Secondary|Number of Participants With Abnormal Physical Examination Findings||Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707004|NCT01193257|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707005|NCT01193257|Secondary|Percentage of Participants With Pain Response at Week 12|Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.|Week 12|ITT population included all participants who were randomized.|||percentage of participants|||Number
2707006|NCT01193257|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12|The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.|Week 12|ITT population included all participants who were randomized.|||percentage of participants|||Number
2707007|NCT01193257|Secondary|Radiographic Progression-free Survival (rPFS)|rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707008|NCT01193257|Primary|Overall Survival|Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.|Baseline until death (approximately up to 4.5 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707009|NCT01193244|Secondary|Time to Deterioration in Global Health Status|Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties).|Baseline until EOT (approximately up to 4.7 years)|The ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707010|NCT01193244|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)|The Response Evaluation Criteria in Solid Tumors (RECIST) evaluable population included all participants who had measurable disease by RECIST 1.1 at the baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2707011|NCT01193244|Secondary|Time to Subsequent Antineoplastic Therapy|Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier.|Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)|The ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707013|NCT01193244|Secondary|Time to PSA Progression|Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA.|Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707014|NCT01193244|Secondary|Percentage of Participants Achieving PSA90 Response at Any Time During the Study|The PSA90 is defined as a decline of PSA by 90 percent from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2707015|NCT01193244|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12|The PSA90 is defined as a decline of PSA by 90 percent from baseline.|Week 12|ITT population included all participants who were randomized.|||percentage of participants|||Number
2707016|NCT01193244|Secondary|Percentage of Participants Achieving PSA50 Response at Any Time During the Study|The PSA50 is defined as a decline of PSA by 50 percent from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2707017|NCT01193244|Secondary|Time to SRE|Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.|Baseline up to EOT (Cycle 61 Day 58)|The ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707018|NCT01193244|Secondary|Percentage of Participants With Skeletal Related Events (SRE)|Skeletal related (SRE) event is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.|Baseline up to EOT (approximately up to 4.7 years)|The ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2707019|NCT01193244|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation||Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707020|NCT01193244|Secondary|Worst Change From Baseline Over Time in Cardiac Ejection Fraction|Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.|Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.|||percent ejection fraction||Standard Deviation|Mean
2707021|NCT01193244|Secondary|Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings||Baseline up to EOT (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707022|NCT01193244|Secondary|Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status|ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50 percent of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.|Baseline until EOT (approximately up to 4.7 years)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707023|NCT01193244|Secondary|Number of Participants With TEAEs Related to Weight||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707024|NCT01193244|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707025|NCT01193244|Secondary|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3|Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE.|Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707026|NCT01193244|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2707055|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 7|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Seven days|Subjects with data at time point.|||cells||Standard Deviation|Mean
2707056|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 2|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two days|Subjects with data at time point.|||cells||Standard Deviation|Mean
2707027|NCT01193244|Secondary|Time to Pain Progression|Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference.|Baseline until End of treatment (EOT) (approximately up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707028|NCT01193244|Secondary|Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12|A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood.|Week 12|ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2707029|NCT01193244|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12|The PSA50 is defined as a decline of at least 50 percent (%) from baseline.|Week 12|ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2707030|NCT01193244|Primary|Overall Survival|Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.|Baseline until death (up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707031|NCT01193244|Primary|Radiographic Progression-free Survival (rPFS)|rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.|Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2707032|NCT01193218|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days|Treated patients|||participants|||Number
2707033|NCT01193218|Secondary|Change From Baseline in FPG|Change from baseline in FPG after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)|||mg/dL||Standard Error|Least Squares Mean
2707034|NCT01193218|Secondary|Occurrence of Treat to Target Efficacy Response|Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)|||percentage of participants||95% Confidence Interval|Number
2707035|NCT01193218|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment.|The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.|baseline and 12 weeks|Full analysis set (FAS)|||percentage of HbA1c||Standard Error|Least Squares Mean
2707036|NCT01193153|Secondary|Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2707037|NCT01193153|Secondary|Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
2707057|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 1|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|One day|Subjects with data at time point.|||cells||Standard Deviation|Mean
2707058|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two hours|Subjects with data at time point.|||cells||Standard Deviation|Mean
2707038|NCT01193153|Secondary|Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2707039|NCT01193153|Secondary|Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
2707040|NCT01193153|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2707041|NCT01193153|Secondary|Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
2707042|NCT01193153|Secondary|Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2707043|NCT01193153|Secondary|Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
2707084|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
2707945|NCT01188369|Secondary|Regional Longitudinal Strain (Unitless)|Index of systolic function derived from single transthoracic echocardiographic (TTE) projection|96 hours after operation until 6 months after operation|||||||
2707044|NCT01193153|Secondary|Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.|Baseline and Endpoint (Week 64/LOCF) in DB period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values.'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||participants|||Number
2707045|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a Scale||Standard Error|Least Squares Mean
2707046|NCT01193153|Secondary|Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a Scale||Standard Deviation|Mean
2707047|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Week 64 of double blind relapse prevention period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Error|Least Squares Mean
2707048|NCT01193153|Primary|Double-blind: Percentage of Participants Who Experienced Relapse|Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.|Day 1 up to Month 15 of double blind relapse prevention period|Double-blind(DB) Intent-to-Treat(ITT) analysis set included all randomly assigned participants who received at least 1 injection of DB study medication.‘n’ signifies participants who were evaluable for each specified category,for each arm.|||percentage of participants|||Number
2707049|NCT01193127|Secondary|Use of Pain Medications After Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects|||participants|||Number
2707050|NCT01193127|Secondary|Use of Pain Medications at Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|All randomized subjects|||participants|||Number
2707051|NCT01193127|Secondary|Postoperative Use of Ophthalmic Anti-inflammatory Medications|Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects|||participants|||Number
2707059|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.|||participants|||Number
2707060|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.|||participants|||Number
2707061|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.|||participants|||Number
2707062|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.|||participants|||Number
2707063|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.|||participants|||Number
2707064|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.|||participants|||Number
2707065|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.|||participants|||Number
2707066|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707067|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707068|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707069|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707070|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707071|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery|"TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707085|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
2707072|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2707073|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 30|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|30 days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
2707074|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 14|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|14 days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
2707075|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 7|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Seven days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
2707076|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 2|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Two days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
2707077|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 1|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|One day|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
2707078|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Baseline|Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Baseline|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
2707079|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
2707080|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
2707081|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
2707082|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
2707083|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
2707086|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
2707087|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
2707088|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
2707089|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
2707090|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
2707091|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
2707092|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
2707093|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
2707094|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
2707095|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
2707096|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
2707097|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
2707098|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
2707099|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
2707100|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
2707101|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
2707102|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
2707103|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
2707104|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
2707105|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
2707106|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
2707107|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
2707108|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
2707109|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
2707110|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
2707111|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
2707112|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
2707113|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
2707114|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|Subjects with scores at time point.|||participants|||Number
2707115|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
2707116|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
2707117|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
2707118|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
2707119|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
2707120|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
2707121|NCT01193127|Primary|Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively|For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.|through 12 hours post-surgery|Subjects with postoperative VAS scores.|||units on a scale||Standard Deviation|Mean
2707122|NCT01193127|Primary|Pupil Diameter (mm) During Surgery|Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.|During surgery (immediately prior to surgical incision to wound closure)|Subjects with interpretable video recordings obtained during surgery.|||mm||Standard Deviation|Mean
2707123|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||units on a scale||Standard Deviation|Mean
2707946|NCT01188369|Secondary|Regional Longitudinal Strain (Unitless)|Index of systolic function derived from single transthoracic echocardiographic (TTE) projection|21 hours after operation until 96 hours after operation|||||||
2707124|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||units on a scale||Standard Deviation|Mean
2707125|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||units on a scale||Standard Deviation|Mean
2707126|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||percent days of substance use||Standard Deviation|Mean
2707127|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||percent days of substance use||Standard Deviation|Mean
2707128|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||percent days of substance use||Standard Deviation|Mean
2707129|NCT01193101|Secondary|Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8|From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.|8 weeks, 9 weeks|Only participants from the full analysis, who had values at both week 8 and week 9, were included in the analysis. The FAS included all randomized participants.|||mmHg||Standard Deviation|Mean
2707130|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS) The FAS included all randomized participants.|||ratio|||Number
2707131|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS): The FAS included all randomized participants.|||ratio|||Number
2707132|NCT01193101|Secondary|Number of Participants Who Achieved Successful BP Control|BP control is defined as BP < 140/90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.|||Participants|||Number
2707133|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.|||Participants|||Number
2707134|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.|||Participants|||Number
2707135|NCT01193101|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707136|NCT01193101|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707137|NCT01193101|Secondary|Change From Baseline in Nighttime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707138|NCT01193101|Secondary|Change From Baseline in Daytime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707139|NCT01193101|Secondary|Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707947|NCT01188369|Secondary|Regional Longitudinal Strain (Unitless)|Index of systolic function derived from single transthoracic echocardiographic (TTE) projection|1 hour before start of operation until 21 hours after operation|||||||
2707140|NCT01193101|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707141|NCT01193101|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
2707142|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then prostaglandin and leukotriene concentrations were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As this same approach in a parallel study was unfruitful, these data were not pursued, and results are not presented.||||||
2707143|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 23 hours had elapsed, BALf were collected, then the concentrations of IL-5, IL-13, and TARC were determined from BALf collected after 23 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 23 hours post-allergen challenge|As concentrations of cytokines were below the lower limit of quantitation this analysis was not performed, and results are not presented.||||||
2707144|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-23 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was plan to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As IL-23 levels were too low to detect, this analysis was not performed and results are not presented.||||||
2707145|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TSLP were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As TSLP levels were too low to detect, this analysis was not performed and results are not presented.||||||
2707146|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707147|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707148|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707149|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707178|NCT01192776|Secondary|Bayley Cognitive Score|Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||scores on a scale||Inter-Quartile Range|Median
2707179|NCT01192776|Secondary|Clinical Neonatal Seizures|Documented seizures during hospital course|Through death, discharge, or transfer||||Participants|||Count of Participants
2707150|NCT01193049|Secondary|Change in Vibration Response Imaging (VRI) After Metacholine Exposure|One hour before treatment with prednisone/placebo, participants inhaled for 2 minutes a nebulised solution of metacholine (0.13 ml/min); then one hour after prednisone/placebo treatment were challenged with allergens. From 1 to 7 hours after allergen challenge, ventilatory heterogeneity was assessed by Vibration Response Imaging (VRI) by monitoring the following: inspiration/expiration (I/E) amplitude ratio, I/E duration ratio, synchrony duration, and quantitative lung data.|From 1 to 7 hours post-allergen challenge|As all VRI results showed no allergen or treatment-related signals these results are not presented.||||||
2707151|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707152|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707153|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707154|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
2707155|NCT01193010|Secondary|Numerical Rating Scale for Satisfaction|Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied|0, 3, 6, 12 months||||Units on a scale||Standard Deviation|Mean
2707156|NCT01193010|Secondary|Numerical Rating Scale for Pain|Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain|0, 3, 6, 12 months||||Units on a scale||Standard Deviation|Mean
2707157|NCT01193010|Secondary|Patient-Rated Wrist Evaluation (PWRE_|PRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function.|0, 3, 6, 12 months||||Units on a scale||Standard Deviation|Mean
2707158|NCT01193010|Primary|Disability of the Shoulder and Hand Score|DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.|0, 3, 6, 12 months||||Units on a scale||Standard Deviation|Mean
2707159|NCT01192828|Other Pre-specified|Difference in Diastolic Blood Pressure in Individuals With CBSDH Receiving Both Low Dose and Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment).||Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who were treated with taurine, this being both low dose and targeted dose of medication.|||mmHg||Standard Deviation|Mean
2707160|NCT01192828|Other Pre-specified|Difference in Systolic Blood Pressure in Individuals With CBSDH Receiving Both Low Dose and Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment).||Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who were treated with taurine, this being both low dose and targeted dose of medication.|||mmHg||Standard Deviation|Mean
2707161|NCT01192828|Other Pre-specified|Difference in Triglycerides in Individuals With CBSDH Receiving Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment)|Triglycerides were measured in a CLIA approved clinical laboratory. Triglycerides are a natural occurring fat, High levels over a long period of time can increase the chances for heart disease. Levels greater that 1000 mg/dl over a short period of time can increase chances of pancreatitis.|Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mg/dL||Standard Error|Mean
2707162|NCT01192828|Other Pre-specified|Difference in Triglycerides in Individuals With CBSDH Receiving Both Low Dose and Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment)|Triglycerides were measured in a CLIA approved clinical laboratory.Triglycerides are a natural occurring fat. High levels over a long period of time can increase the chances for heart disease. Levels greater that 1000 mg/dl over a short period of time can increase chances of pancreatitis.|Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who were treated with taurine, this being both low dose and targeted dose of medication.|||mg/dL||Standard Error|Mean
2707163|NCT01192828|Other Pre-specified|Determination of Baseline Taurine Level, Peak Taurine Level on Day One, Trough Level on Day One and Trough Level on Day Four of Taurine Treatment.|Taurine was measured in plasma via liquid chromatogram(LC)-MS/MS.|Taurine levels were obtained prior to taurine adminstration and at , t=0.5, t=1, t=2, t=3, t=4, t=6, t=8, t=12 and 96 hours.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||microM||Standard Deviation|Mean
2707164|NCT01192828|Other Pre-specified|Thiobarbituric Acid Reactive Substances (TBARS) in Individuals With CBSDH Compare to Homocysteine Level.|TBARS were measured in plasma via colorimetric absorbance. Homocysteine was measured in serum by gas chromatography/mass spectrometry (GC/MS) in a Clinical Laboratory Improvements Amendments (CLIA) approved clinical laboratory. TBARS are a marker of oxidative stress. TBARS are formed as a by-product of lipid (fat) oxidation. TBARS predominantly reflect the level of malondialdehyde (MDA) a substance that is formed from the breakdown of polyunsaturated fatty acids.|Baseline|Analyzable data from all subjects with CBSDH who completed day one of active study and normal homocysteine values provided by assaying laboratory were used for the calculations.|||micromol/l||Standard Error|Mean
2707165|NCT01192828|Secondary|Percent of Individuals With Decreased Bone Mineral Density.|Bone mineral density was assessed via whole body dual energy X-ray absorptiometry (DEXA) with bone density corrected for age. The absolute DEXA value was not used for analysis, rather values below 2 standard deviations of normal were taken as evidence of osteoporosis.|Baseline|Analysis was on all analyzable data from subjects with CBSDH who participated in the active study and data from control population as provided by DEXA report.|||Participants|||Count of Participants
2707166|NCT01192828|Secondary|Difference in Endothelial Function (Blood Vessel Function) in Individuals With CBSDH and Pre Taurine Exposure FMD Values Less Than 10 mm Pre and Post Taurine Treatment.|Endothelial function was measured by doppler brachial artery flow-mediated dilation (FMD) studies.|Baseline and after 4.5 days of therapy.|Analyzable data from all individuals with CBSDH studied with baseline flow mediated dilation values of less than 10 mm and who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mm||Standard Error|Mean
2707167|NCT01192828|Secondary|Difference in Endothelial Function (Blood Vessel Function) in Individuals With CBSDH and Homocysteine Levels Greater Than 125 Micromole/L Pre and Post Taurine Treatment.|Endothelial function was measured by doppler brachial artery flow-mediated dilation (FMD) studies.|Baseline and after 4.5 days of therapy.|Analyzable data from all individuals with CBSDH having baseline homocysteine levels greater than 125 micromole/L who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mm||Standard Error|Mean
2707168|NCT01192828|Secondary|Difference in Endothelial Function (Blood Vessel Function) in Individuals With CBSDH Pre and Post Taurine Treatment|Endothelial function was measured by doppler brachial artery flow-mediated dilation (FMD) studies.|Baseline and after 4.5 days of taurine treatment|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mm||Standard Error|Mean
2707169|NCT01192828|Primary|Difference in Tumor Necrosis Factor Alpha (TNF-alpha) in Individuals With CBSDH Pre and Post Taurine Treatment.|TNF-alpha was measured in plasma via Luminex high sensitivity assay. TNF-alpha is a signaling protein, or cytokine that promotes an inflammatory response.|Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||pg/ml||Standard Error|Mean
2707170|NCT01192828|Primary|Difference in Thiobarbituric Acid Reactive Substances (TBARS) in Individuals With Cystathionine Beta Synthase Deficient Homocystinuria (CBSDH) Pre and Post Taurine Treatment.|TBARS were measured in plasma via colorimetric absorbance. TBARS are a marker of oxidative stress. They are formed as a by-product of lipid (fat) oxidation. TBARS predominantly reflect the level of malondialdehyde (MDA) a substance that is formed from the breakdown of polyunsaturated fatty acids.|Baseline and after 4 days of therapy.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from he analysis.|||nmol/ml||Standard Error|Mean
2707171|NCT01192776|Other Pre-specified|Severe Neonatal Brain Abnormalities|"The data for this analysis have not yet been collected.~MRIs taken between 7-14 days will be examined."|7-14 days of life||2020-07-31|07/2020||||
2707172|NCT01192776|Secondary|Multiorgan Dysfunction|The data needed for this analysis are not collected directly, and will not be analyzed as the study was terminated early and no funds available to complete this complex analysis. The data for this study will be stored at the NICHD-DASH for investigators.|Until death, discharge, or transfer|No patients were analyzed for this outcome as the study was terminated early and no additional funds available to complete this complex analysis.||||||
2707173|NCT01192776|Secondary|Multiple Disabilities|Multiple disabilities is defined as two or more of the following 5 components: disabling CP, GMFCS level 3-5, Bayley cognitive score < 70, blindness, or deafness.|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
2707174|NCT01192776|Secondary|Hearing Impairment|Hearing impairment is defined as hearing impairment despite amplification|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
2707175|NCT01192776|Secondary|Visual Impairment|Visual impairment is defined as bilateral blindness with some/no useful vision|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
2707176|NCT01192776|Secondary|Level of Disability Among Survivors, by Level of HIE|Among survivors, number of normal infants and infants with mild, moderate and severe disability Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge.|Follow up at 18-22 months corrected age|Includes all infants followed at 18-22 months, except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths.|||Participants|||Count of Participants
2707177|NCT01192776|Secondary|Cerebral Palsy||Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
2707181|NCT01192776|Secondary|Level of Disability Among Survivors|"Among survivors number of normal infants and infants with mild, moderate, and severe disability~Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge."|Follow up at 18-22 months corrected age|Includes all infants followed at 18-22 months except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths|||Participants|||Count of Participants
2707182|NCT01192776|Secondary|Death|Death includes any mortality prior to follow up at 18-22 months.|Birth to 22 months corrected age|Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.|||Participants|||Count of Participants
2707183|NCT01192776|Primary|Death or Moderate to Severe Disability|Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands.|Birth to 22 months corrected age|Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.|||Participants|||Count of Participants
2707184|NCT01192698|Primary|HCV RNA Result|Will measure mean HCV RNA levels 4 weeks after liver transplant|4 weeks after liver transplant||||IU/ml||Standard Deviation|Mean
2707185|NCT01192542|Primary|Binocular Visual Acuity|Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results|Post lens insertion (baseline)|Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.|||LogMAR||Standard Error|Least Squares Mean
2707186|NCT01192542|Secondary|Bulbar Redness of Grade 3 or Above|Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.|||Subject Eyes|Eyes||Number
2707187|NCT01192542|Secondary|Limbal Redness of Grade 3 or Above|Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.|||Subject Eyes|Eyes||Number
2707188|NCT01192542|Primary|Monocular Visual Acuity Assessment|Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.|Post lens insertion (baseline)|Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.|||logMAR|eyes|Standard Error|Least Squares Mean
2707189|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance people walk in feet over 6 minutes|6 months post baseline|Numbers may differ due to missing data|||feet||Standard Deviation|Mean
2707190|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance in feet that people walk over 6 minutes.|10 weeks post-baseline|Numbers may differ due to missing data|||feet||Standard Deviation|Mean
2707191|NCT01192516|Secondary|Physical Function- Six Minute Walk|Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes|Baseline|Numbers may vary due to missing data|||feet||Standard Deviation|Mean
2707192|NCT01192516|Primary|Pain- WOMAC|This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.|6 months post baseline|Numbers may vary due to missing data|||units on a scale||Standard Deviation|Mean
2707193|NCT01192516|Primary|Pain- WOMAC|This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.|10 weeks post-baseline|Sample numbers may differ due to missing data|||units on a scale||Standard Deviation|Mean
2707194|NCT01192516|Primary|Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.|Baseline||||units on a scale||Standard Deviation|Mean
2707195|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.|6 months post-baseline|Sample numbers may vary due to missing data|||units on a scale||Standard Deviation|Mean
2707196|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|10 weeks post-baseline|Sample numbers may differ due to missing data|||units on a scale||Standard Deviation|Mean
2707197|NCT01192516|Primary|Fatigue- Brief Fatigue Inventory (BFI)|This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|Baseline||||units on a scale||Standard Deviation|Mean
2707198|NCT01192412|Secondary|Serious Maternal Complications Measured up to 6 Weeks Postpartum|"Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:~Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or~End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion)"|6 weeks||||participants|||Number
2707240|NCT01192204|Secondary|Treatment Changes in Loss of Heterozygosity Events|Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes.|Before and after the 3 month treatment duration||||LOH events||Standard Error|Mean
2707199|NCT01192412|Primary|Pregnancy Loss or NICU Admission for Greater Than 48 Hours|Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records.|6 weeks||||participants|||Number
2707200|NCT01192399|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Score (Global Health Status)|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. For global health status, a high score represents a high quality of life.|Baseline, Week 12||||units on a scale||Standard Error|Least Squares Mean
2707201|NCT01192399|Secondary|Change From Baseline in Plasma Free Hemoglobin||Baseline, Week 12||||mg/dL||Standard Error|Mean
2707202|NCT01192399|Secondary|Change From Baseline in Lactate Dehydrogenase (LDH) Area Under the Curve (AUC)||Baseline to Week 12||||U/L x Day||Standard Error|Mean
2707203|NCT01192399|Secondary|Number of Units of Packed Red Blood Cells (pRBCs) Transfused|Comparison of number of units of pRBCs transfused in the 12 weeks prior to the first dose of eculizumab, and between baseline and 12 weeks after the first dose of eculizumab|12 weeks pre-treatment, baseline, 12 weeks post-treatment||||Units||Standard Error|Mean
2707204|NCT01192399|Secondary|Change From Baseline in Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Count||Baseline, Week 12||||cells x 10^12/L||Standard Error|Mean
2707205|NCT01192399|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Total Score|The FACIT-Fatigue scale, Version 4.0, is a collection of quality of life questionnaires pertaining to the management of fatigue symptoms due to a chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Patients score each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher score indicating better quality of life.|Baseline, Week 12||||units on a scale||Standard Error|Mean
2707206|NCT01192399|Primary|Change From Baseline in Lactate Dehydrogenase||Baseline, Week 12||||Units/Liter||Standard Error|Mean
2707207|NCT01192347|Secondary|Maximum Daily Dose of Anagrelide Hydrochloride||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||mg/day||Standard Deviation|Mean
2707208|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
2707209|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
2707210|NCT01192347|Secondary|Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
2707211|NCT01192347|Secondary|Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
2707269|NCT01192152|Primary|Metformin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707212|NCT01192347|Secondary|Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
2707213|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707214|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707215|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707216|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707217|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707265|NCT01192152|Secondary|Metformin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707948|NCT01188369|Secondary|Pulmonary Artery Pressures (mmHg)|Invasive measurement of mean pressure in the pulmonary artery|4 hours after operation until 21 hours after operation|||||||
2707218|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707219|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707220|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707221|NCT01192347|Secondary|Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||participants|||Number
2707222|NCT01192347|Secondary|Percentage of Subjects With Anagrelide Hydrochloride Starting Doses||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
2707223|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707224|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
2707225|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio|A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau).|Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]|Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.|||Ratio||90% Confidence Interval|Median
2707226|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)|A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose.|Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]|Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.|||Hours||90% Confidence Interval|Median
2707227|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss|"A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours.~The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state)."|Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]|Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.|||ng*hour/mL||90% Confidence Interval|Median
2707228|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets|"A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio.~The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state)."|Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]|Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration.|||ng/mL||90% Confidence Interval|Median
2707229|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
2707230|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
2707231|NCT01192295|Secondary|Parent/ Caregiver-Assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.|Baseline to week 4 or early discontinuation|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||participants|||Number
2707232|NCT01192295|Secondary|Use of Supplemental Pain Medication|Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||participants|||Number
2707233|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years|"Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked no pain and the opposite end marked as pain as bad as it could be. The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the no pain end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment."|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
2707234|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged 6 to < 12 Years|"Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with no hurt at the far left and hurts worst at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment."|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
2707235|NCT01192295|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.|Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||participants|||Number
2707241|NCT01192204|Secondary|Changes in Lesional Sizes|The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number.|pretreatment and posttreatment (3 months treatment duration)||||mm^2||Standard Deviation|Mean
2707242|NCT01192204|Primary|Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment|A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).|Before and after the 3 month treatment.|The population evaluated were as previously described i.e. 22 participants in the BRB gel cohort and 18 participants in the placebo gel cohort.|||unit on histologic grade scale||Standard Error|Mean
2707243|NCT01192191|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.|Baseline (Week -2), Week 12, Week 24, and Week 52|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2707244|NCT01192191|Secondary|Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Beats/Minute||Standard Deviation|Mean
2707245|NCT01192191|Secondary|Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2707246|NCT01192191|Secondary|Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)|24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)|The Urine Cortisol Population: all participants in the ITT Population for whom a urine sample was obtained and whose urine sample was not considered to have confounding factors that could affect the interpretation of the results. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
2707247|NCT01192191|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2707248|NCT01192191|Secondary|Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2707249|NCT01192191|Secondary|Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2707250|NCT01192191|Secondary|Number of Participants With Pneumonia During the Treatment Period|Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population|||Participants|||Number
2707251|NCT01192191|Primary|Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population|||Participants|||Number
2707252|NCT01192191|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period|||Participants|||Number
2707253|NCT01192178|Secondary|Mean Percentage of Rescue-free Days|A rescue-free day was defined as a day during the Peak Viral Period on which no puffs of rescue medication were recorded. Percentage of rescue-free days was defined as the number of days during the Peak Viral Period on which no puffs of rescue medication were recorded, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.|||Percentage of days||Standard Deviation|Mean
2707254|NCT01192178|Secondary|Mean Percentage of Symptom-free Days|A symptom-free day was defined as a day during the Peak Viral Period on which the asthma symptom score was zero. The daily asthma symptom score (measured during the day and the previous night) was reported on a 6-point scale (ranging from 0=no symptoms to 5=severe symptoms). Percentage of symptom-free days was defined as the number of days during the Peak Viral Period on which the asthma symptom score=0, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.|||Percentage of days||Standard Deviation|Mean
2707255|NCT01192178|Secondary|Mean Percentage of Episode-free (EF) Days|An EF day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, school absenteeism due to asthma, or morning peak expiratory flow (measure of maximum airflow) <80% of baseline. Percentage of EF days=No. of EF days divided by No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.|||Percentage of days||Standard Error|Mean
2707266|NCT01192152|Secondary|Metformin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||percentage of fluctuation||Standard Deviation|Mean
2707256|NCT01192178|Secondary|Mean Percentage of Asthma-control Days|An asthma-control day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than double-blind study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, or school absenteeism due to asthma. The percentage of asthma-control days = the number (No.) of asthma-control days divided by the No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.|||Percentage of days||Standard Error|Mean
2707257|NCT01192178|Secondary|Number of Asthma Exacerbations Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection During the Peak Viral Period|Each participant (with assistance from the parent/legal guardian as needed) was instructed to keep an electronic diary (eDiary) with record of daily URTS symptoms that included: runny nose, sneezing, nasal congestion, and sore throat. Based on the best-described aggregate URTS during the previous 24 hours, participants rated symptoms as: 0 = Not present; 1 = Mild, clearly present; 2 = Moderately severe, uncomfortable; and 3 = Severe, interfering with sleep or activity. Mucus samples were collected and analyzed for RVwhen the eDiary alerted for moderate/severe URTS.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who reported >=1 exacerbation were analyzed. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.|||Number of asthma exacerbations|||Number
2707258|NCT01192178|Secondary|Mean Duration of Worsening Asthma Symptoms Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection|A worsening asthma day is one on which any of the following occurred: rescue albuterol use above baseline, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study medication, asthma symptom scores >=3, nighttime awakenings, unscheduled health care visits, or missed school due to asthma. The duration of worsening asthma is the number of consecutive worsening asthma days after the date of a URTS score of 2 (moderate) or 3 (severe) or collection of a mucus sample containing RV (whichever occurred first). Each span of consecutive days is a participant interval.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants with relevant data defining a worsening asthma day during the peak viral period and with moderate or severe URTS or a confirmed RV infection were analyzed.|||Days per participant interval||Standard Error|Mean
2707259|NCT01192178|Secondary|Mean Asthma Symptom Scores, as an Indicator of Severity, Associated With the Presence of Moderate or Severe Upper Respiratory Tract Symptoms (URTS) or a Confirmed Rhinovirus (RV) Infection at Baseline and During the Peak Viral Period|Participants recorded their asthma symptom score over the previous 24 hours (during the day and the previous night) using the following 6-point scale: 0=No symptoms; 1=Symptoms for 1 short period; 2=Symptoms for >=2 short periods; 3=Symptoms for most of the day/previous night that did not affect normal daily activities; 4=Symptoms for most of the day/previous night that affected normal daily activities; 5=Symptoms so severe that participant could not perform normal daily activities. The Baseline mean asthma symptom score was calculated as the average score over 7 days prior to Week 1, Visit 2.|Baseline (Week 1) and Peak Viral Period ([period during which the greatest number of viral infections is expected] from 30 August 2010 through the end of the treatment period [up to Week 16])|ITT Population. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.|||Scores on a scale||Standard Deviation|Mean
2707260|NCT01192178|Primary|Total Number of Asthma Exacerbations Reported During the Treatment Period|An asthma exacerbation was defined as deterioration of asthma that required the use of outpatient oral/parenteral corticosteroids (tablets, suspensions, or injection) or an urgent care, hospitalization, or emergency room (ER) visit due to asthma that required oral/parenteral corticosteroids. Two exacerbations (out of a total of 51) were excluded: (1) one exacerbation occurred within 7 days of the resolution of an earlier one, and, per protocol, was combined with the previous exacerbation; and (2) one exacerbation occurred post treatment.|From Baseline (Week 1) until the end of treatment (up to Week 16)|Intent-to-Treat (ITT) Population: all participants randomized to treatment. Only those participants who reported >=1 exacerbation were analyzed.|||Number of asthma exacerbations|||Number
2707261|NCT01192152|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities considered clinically significant and/or reported as an AE by the investigator.|From Day 1 of Period 1 to Day 3 of Period 2 for participants in Treatment Sequence BA and Day 5 of Period 3 for participants in Treatment Sequence ABC|All subjects who received at least one dose of study medication.|||participants|||Number
2707262|NCT01192152|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on morning of Day 1/Period 1 through study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|All subjects who received at least one dose of study medication.|||participants|||Number
2707263|NCT01192152|Secondary|Metformin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||hour||Standard Deviation|Mean
2707264|NCT01192152|Secondary|Metformin AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C was administered only during Period 3, & this measure was analyzed for Periods 1 and 2.|||ratio||Standard Deviation|Mean
2707271|NCT01192152|Secondary|Metformin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707272|NCT01192152|Primary|Metformin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded due to the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707273|NCT01192152|Secondary|5-hydroxy Saxagliptin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||hour||Standard Deviation|Mean
2707274|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)/AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ratio||Standard Deviation|Mean
2707275|NCT01192152|Secondary|5-hydroxy Saxagliptin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707276|NCT01192152|Secondary|5-hydroxy Saxagliptin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||percentage of fluctuation||Standard Deviation|Mean
2707277|NCT01192152|Secondary|5-hydroxy Saxagliptin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707278|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707279|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707280|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng*hr/mL||Standard Deviation|Mean
2707281|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707282|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707283|NCT01192152|Secondary|Saxagliptin Time to Achieve the Observed Maximum Plasma Concentration (Tmax)||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||hour||Standard Deviation|Mean
2707284|NCT01192152|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ratio||Standard Deviation|Mean
2707285|NCT01192152|Secondary|Saxagliptin Terminal Half-life (T1/2)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707286|NCT01192152|Secondary|Saxagliptin Degree of Fluctuation Over the Dosing Interval (Fluctuation %)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||percentage of fluctuation||Standard Deviation|Mean
2707949|NCT01188369|Secondary|Pulmonary Artery Pressures (mmHg)|Invasive measurement of mean pressure in the pulmonary artery|End of operation until approx 4 hours after operation|||||||
2707287|NCT01192152|Secondary|Saxagliptin Average Plasma Concentration Over the Dosing Period (Cavg)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707288|NCT01192152|Secondary|Saxagliptin Trough (Predose) Plasma Concentration (Cmin)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707289|NCT01192152|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1 & 2: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 & 48 hrs post-dosing. Period 3: predosing on Days 2 & 3; predosing, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hrs postdosing on Day 4|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
2707290|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC[0-tau])|Dosing interval = 24 hours.|Period 3: pre-dosing on Days 2 and 3; pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours post-dosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng*hr/mL||Standard Deviation|Mean
2707291|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707292|NCT01192152|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2707293|NCT01192139|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and Electrocardiogram (ECG) Abnormalities|Abnormalities considered by the investigator to be clinically significant and/or reported as an AE.|From Day 1 of Period 1 through Day 3 of Period 3 (study discharge)|Safety Population|||Participants|||Number
2707294|NCT01192139|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on Day 1/Period 1 through study discharge Day 3/Period 3. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|Safety Population = all participants who received any study drug.|||Participants|||Number
2707295|NCT01192139|Secondary|Metformin Fraction of AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC(0-inf) was due to the inability to estimate Kel for some of the subjects).|||ratio||Standard Deviation|Mean
2707296|NCT01192139|Secondary|Metformin Tmax||Periods 1, 2, and 3 (before dosing, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
2707297|NCT01192139|Secondary|Metformin T1/2|terminal half life; calculated as ln(2)/Kel|Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for T1/2 was due to the inability to estimate Kel for some of the subjects).|||hours||Standard Deviation|Mean
2707298|NCT01192139|Primary|Metformin Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng/mL||Standard Deviation|Mean
2707299|NCT01192139|Secondary|Metformin AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
2707300|NCT01192139|Primary|Metformin AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC[0-inf] was due to the inability to estimate potassium chloride for some participants)|||ng*hr/mL||Standard Deviation|Mean
2707301|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)/AUC(0-inf)||Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants|||ratio||Standard Deviation|Mean
2707302|NCT01192139|Secondary|Active Metabolite BMS-510849 Tmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
2707303|NCT01192139|Secondary|Active Metabolite BMS-510849 T1/2|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
2707304|NCT01192139|Secondary|Active Metabolite BMS-510849 Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng/mL||Standard Deviation|Mean
2707305|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
2707306|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
2707307|NCT01192139|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ratio||Standard Deviation|Mean
2707308|NCT01192139|Secondary|Time to Achieve the Observed Maximum Saxagliptin Plasma Concentration (Tmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
2707309|NCT01192139|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng/mL||Standard Deviation|Mean
2707310|NCT01192139|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
2707311|NCT01192139|Secondary|Saxagliptin Terminal Half-life (T1/2)|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
2707312|NCT01192139|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
2707313|NCT01192126|Primary|Slit Lamp Examination > Grade 2|Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.|All study visits from screening through 2 week follow-up|All Dispensed Eyes|||Eyes|Participants||Number
2707314|NCT01192126|Primary|Visual Acuity|Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.|Dispensing Visit and 1 week follow-up|All Eligible Dispensed Eyes|||LogMAR|Participants|Standard Deviation|Mean
2707315|NCT01192100|Secondary|Daily Energy Intake|Energy intake during breakfast, lunch, dinner, and evening snacks of each testing day will be measured.|5 weeks||||kilocalories||Standard Error|Mean
2707316|NCT01192100|Primary|Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans|Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of breakfast/no breakfast on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing]. To identify significant activations in a priori regions, a cluster level statistical threshold was applied to correct for multiple comparisons. By using this approach, significance was set at P = 0.01, with a cluster-level false-positive rate of a = 0.05|5 weeks|Coordinates were only determined for regions considered significant by analysis using Brain Voyager.|||Talairach Coordinates|||Number
2707317|NCT01192100|Primary|Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY)|The samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored in microcentrifuge tubes at -80°C for future analysis. Plasma total ghrelin and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies. AUC was calculated by computing the summation of the average change from baseline score (pg/ml) for each time point and the subsequent time point multiplied by the difference in time (min) between the two time instances for a total of 20 blood samples (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min).|5 weeks||||(pg*min)/ml||Standard Error|Mean
2707340|NCT01191944|Secondary|Change From Baseline in Percentage Off-time During Waking Hours at Week 18|Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced Parkinsons Disease (PD). Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage off-time||Standard Error|Least Squares Mean
2707318|NCT01192100|Primary|Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption|"Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days beginning at baseline and about every 30 minutes for a total of 20 questionnaires (- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min). The questions are worded as how strong is your feeling of with anchors of not at all to extremely. Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated by computing the summation of the average change from baseline score (mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as feeling more hungry throughout the day. This can be applied to the three other perceived sensations."|5 weeks||||mm*min||Standard Error|Mean
2707319|NCT01192022|Secondary|Time to Intraoperative Hemostasis at Target Bleeding Site|The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.|10 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.|||minutes||Full Range|Median
2707320|NCT01192022|Secondary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes|3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 5 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.|||percentage of participants||95% Confidence Interval|Number
2707321|NCT01192022|Primary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes|3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 3 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.|||percentage of participants||95% Confidence Interval|Number
2707322|NCT01191944|Secondary|Levodopa (L-Dopa) Dose Change During the Study|Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented.|18 weeks|FAS. Only patients with concomitant L-Dopa treatment at baseline.|||mg||Standard Deviation|Mean
2707323|NCT01191944|Secondary|Levodopa (L-Dopa) Introduction During the Study|Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study.|18 weeks|FAS. Only patients without concomitant L-Dopa treatment at baseline.|||Participants|||Number
2707324|NCT01191944|Secondary|Change From Baseline in UPDRS III Score Separately at Week 18|UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)|||Units on a scale||Standard Error|Least Squares Mean
2707325|NCT01191944|Other Pre-specified|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks|ESS is a patient-report scale with 8 items rating how likely one is to fall asleep during passive and inconsequential situations such as watching television, more active situations such as sitting and talking to someone, or consequential situations such as sitting in a car, while stopped for a few minutes in traffic. The likelihood of dozing off is rated from 0 points (no chance) to 3 points (high chance). The overall rating scale is scored from 0 (no daytime sleep) to 24 (worst daytime sleep).|Baseline and week 18|Observed cases (OC). Only patients with ESS assessment at baseline and at 18 weeks were analyzed.|||Units on a scale||Standard Deviation|Mean
2707326|NCT01191944|Secondary|Change From Baseline in UPDRS II Score Separately at Week 18|UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)|||Units on a scale||Standard Error|Least Squares Mean
2707327|NCT01191944|Secondary|Responder in UPDRS Parts II+III Score at Week 18|Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108).|Baseline and week 18|FAS (LOCF)|||Participants|||Number
2707328|NCT01191944|Secondary|Patient Global Impressions of Improvement (PGI-I) Responder at Week 18|The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF)|||Participants|||Number
2707329|NCT01191944|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder at Week 18|CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF). Only patients with on-treatment CGI-I evaluation were analyzed.|||Participants|||Number
2707330|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18|Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
2707382|NCT01191268|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 4 weeks after last dose|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
2707331|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18|Duration of on-time without Dyskinesia or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
2707332|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18|Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
2707333|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without Dyskinesia at Week 18|Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
2707334|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
2707335|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18|Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
2707336|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
2707337|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
2707338|NCT01191944|Secondary|Responder in Percentage Off-time During Waking Hours at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Participants|||Number
2707339|NCT01191944|Secondary|Change From Baseline in Duration of Off-time During Waking Hours at Week 18|Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
2707341|NCT01191944|Primary|Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|Full analysis set (FAS) with last observation carried forward (LOCF). FAS is defined as all randomised patients which received at least one dose of study drug and provided any post baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
2707342|NCT01191840|Secondary|Antibiotic Days by Treatment Group|This will be analyzed by evaluating the difference in antibiotic days by treatment group and calculating 95% confidence intervals around the difference in antibiotic days among study patients randomized to algorithm-based treatment vs. among study patients randomized to standard treatment.|Test of cure 2 (up to approximately 42 days)|PP (per protocol) population and PPE Population: Patients from the PP population who did not have complicated staphylococcal infection.|||Days||Standard Deviation|Mean
2707343|NCT01191840|Primary|Number of Participants That Changed From Vancomycin to Another Study Antibiotic Due to an Adverse Event|Patient changes from vancomycin or a protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE associated with study drug|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
2707344|NCT01191840|Primary|Number of Participants With Adverse Events Leading to Study Drug Withdrawal|Number of Participants with an Adverse Event leading to study drug withdrawal|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
2707345|NCT01191840|Primary|Number of Participants With Serious Adverse Events|Number of Participants that reported a Serious Adverse Event|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
2707346|NCT01191840|Primary|Cure Rate|To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy.|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
2707347|NCT01191827|Primary|Neuronal Response During Sensory Gating|Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.|Immediate||||% BOLD signal||Standard Deviation|Mean
2707348|NCT01191801|Other Pre-specified|Leukemia-Free Survival (LFS)|Durability of remission (CR) assessed by LFS|Up to 5 years or the duration of the study|Subset of Intent to Treat patients that have a Measured CR|||Months||95% Confidence Interval|Median
2707349|NCT01191801|Other Pre-specified|Event Free Survival (EFS)||Up to 5 years or duration of study|Intent to Treat Population|||months||95% Confidence Interval|Median
2707350|NCT01191801|Other Pre-specified|Overall Remission (OR) Rate Based on the IWG Response Criteria|"Group A patient OR compared to Group B patient OR~Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent."|Up to 5 years or the duration of the study|Intent to Treat Population|||percentage of participants||95% Confidence Interval|Number
2707351|NCT01191801|Secondary|All Cause Mortality|Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality|60 Days|Safety Population (705)|||percentage of Participants||95% Confidence Interval|Number
2707352|NCT01191801|Secondary|All Cause Mortality|Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality|30 Days|Safety Population (705)|||percentage of Participants in the Group||95% Confidence Interval|Number
2707353|NCT01191801|Secondary|Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.|Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts.|Up to 5 years or duration of study|The percentage of patients who achieved CR was adjudicated by the CPARR (Central Pathology and Response Review) panel using modified IWG response criteria. The outcome measure reflects the Intent to Treat Population.|||percentage of particpants||95% Confidence Interval|Number
2707354|NCT01191801|Primary|Overall Survival|Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival|Up to 5 years or duration of study|The intent-to-treat (ITT) population which consists of all patients enrolled (randomly assigned to treatment group).|||Months||95% Confidence Interval|Median
2707355|NCT01191788|Secondary|Mental Health Functioning as Measured by SF-12 MCS.|The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.|3 Months Post Treatment||||SF-12 score||Standard Deviation|Mean
2707356|NCT01191788|Primary|Depressive Symptoms as Measured by the Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.|3 Months Post Treatment||||BDI-II score||Standard Deviation|Mean
2707357|NCT01191762|Primary|Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate|This outcome measure documented the effect of intestinal phosphate-binding on [PTH]. Fractional change was calculated as ([PTH]post - [PTH]pre)/[PTH]pre, where 'pre' and 'post' referred respectively to baseline [PTH] (before treatment) and [PTH] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.|4 weeks||||percentage of baseline [PTH]||Standard Error|Mean
2707394|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||picogram per milliliter (pcg/mL)||Inter-Quartile Range|Median
2707358|NCT01191749|Primary|Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria|Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count <100 x 10^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10^9/L.|Up to 6 months following treatment; response assessed every 2 months|One subject’s response was indeterminate due to the absence of end of therapy assessments.|||participants|||Number
2707359|NCT01191736|Secondary|The Proportion of Subjects Who Assessed the Responsiveness of the Victim (Manikin) as Judged by Expert Raters|The proportion of the subjects who assessed the responsiveness of the victim (manikin) as judged by expert raters|60 minutes after intervention and two months after intervention||||Proportion of Participants||95% Confidence Interval|Mean
2707360|NCT01191736|Primary|Median Compression Depth (mm)|Assessment of resuscitation skills using a Laerdal Resusci Annie recording manikin and Laerdal PC Skill Reporting software|60 minutes after intervention or two months after intervention|Per protocol|||millimeters||Inter-Quartile Range|Median
2707361|NCT01191723|Secondary|Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours|The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.|baseline, 30 minutes, and 2 hours|Patients with data available at required time point were included in the analysis population.|||beats per minute (bpm)||Standard Deviation|Mean
2707362|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
2707363|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
2707364|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
2707365|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
2707366|NCT01191476|Secondary|Time to Orientation|Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).|Every minute after anesthesia was stopped until orientation occurred||||Minutes||Standard Deviation|Mean
2707367|NCT01191476|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.|Every minute after anesthesia was stopped until extubation occurred|Measurement|||Minutes||Standard Deviation|Mean
2707368|NCT01191476|Secondary|Time to Eye Opening|Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.|Every minute after anesthesia was stopped until the subjects' eyes opened||||Minutes||Standard Deviation|Mean
2707369|NCT01191476|Secondary|Time to Loss of Consciousness|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.|Up to 10 minutes||||seconds||Standard Deviation|Mean
2707370|NCT01191476|Primary|Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane|"[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];~[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];~[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].~The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused."|Anesthetic Duration between 1 to 3 Hours|The full analysis set was used for the determination of cost of anesthesia.|||Yuan||Standard Deviation|Mean
2707371|NCT01191411|Primary|Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.|To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.|1 year|Overall, out of 1593 patients assigned to FIT outreach, 648 were screened; out of 479 assigned to colonoscopy outreach, 118 were screened; and out of 3898 assigned to usual care, 471 were screened.|||percentage of participants|||Number
2707372|NCT01191398|Secondary|Monitoring of Adverse Events During Study Administration|Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.|1 hour||||adverse events|||Number
2707373|NCT01191398|Primary|Difference in Salivary Flow Rate (ml/Min) Between Study Groups|Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)|30 minutes||||ml/min||Standard Deviation|Mean
2707374|NCT01191333|Secondary|Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS)|As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
2707375|NCT01191333|Secondary|Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS)|The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
2707376|NCT01191333|Secondary|Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS)|The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
2707377|NCT01191333|Secondary|Mean Depression Score as Assessed by Beck Depression Inventory (BDI)|This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.|Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
2707378|NCT01191333|Secondary|Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS)|To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
2707379|NCT01191333|Primary|The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression|The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.|End of acute treatment 4-6 weeks|ITT|||Participants|||Count of Participants
2707380|NCT01191320|Primary|Change in HbA1C|The change in HbA1c from Baseline to 3 Months for each treatment arm|3 months|ITT population|||Ratio||Standard Deviation|Mean
2707381|NCT01191268|Secondary|Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
2707395|NCT01191268|Secondary|Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data.|||units per liter (U/L)||Standard Deviation|Mean
2707383|NCT01191268|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
2707384|NCT01191268|Secondary|Rate of Self-reported Hypoglycemic Events up to 52 Weeks|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
2707385|NCT01191268|Secondary|Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.|||participants|||Number
2707386|NCT01191268|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||events|||Number
2707387|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2707388|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
2707389|NCT01191268|Secondary|Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated pulse rate was measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Deviation|Mean
2707390|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2707391|NCT01191268|Secondary|Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.|||milliliters of mercury (mmHg)||Standard Deviation|Mean
2707392|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.|||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
2707393|NCT01191268|Secondary|Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data.|||picomole per liter||Standard Deviation|Mean
2707396|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter (U/L)||Inter-Quartile Range|Median
2707397|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2707398|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2707399|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)|"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate."|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2707400|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2707401|NCT01191268|Secondary|Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
2707402|NCT01191268|Secondary|Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data.|||kilograms (kg)||Standard Deviation|Mean
2707417|NCT01191242|Primary|(R)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2707418|NCT01191242|Primary|(S)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2707419|NCT01191242|Primary|(S)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2707420|NCT01191242|Primary|Total EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2707403|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
2707404|NCT01191268|Secondary|Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)|Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.|Baseline and 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||units||Standard Deviation|Mean
2707405|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose|Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2707406|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMPG data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)]||Standard Error|Least Squares Mean
2707407|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia|The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2707408|NCT01191268|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2707409|NCT01191268|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2707410|NCT01191268|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2707411|NCT01191255|Secondary|ESA Analysis|Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)|52 weeks||||Units/Day||Full Range|Median
2707412|NCT01191255|Secondary|IV Iron Analysis|Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)|52 weeks||||mg/day||Full Range|Median
2707413|NCT01191255|Secondary|Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)||52 weeks|Full Analysis Population (LOCF)|||% Saturation||Standard Deviation|Mean
2707414|NCT01191255|Secondary|Change in Mean Serum Ferritin From Baseline to Week 52||52 weeks|Full Analysis Population (LOCF)|||ng/mL||Standard Deviation|Mean
2707415|NCT01191255|Primary|Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)|Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.|4 weeks|Full Analysis Population (LOCF)|||mg/dL||Standard Deviation|Mean
2707416|NCT01191242|Primary|(R)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2707432|NCT01191190|Secondary|IwCLL-WG Defined Progressive Disease (PD)|"Responses were assessed two months after completion of therapy~Progressive Disease is defined as:~Greater than or equal to 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be ≥ 2 cm; or the appearance of a new palpable lymph node; OR~Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margins; or appearance of palpable hepatomegaly or splenomegaly, which was not previously present; OR~Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5,000μl; OR~Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with ≥ 56% prolymphocytes);"|2 months||||participants|||Number
2707433|NCT01191190|Secondary|IwCLL-WG Defined Stable Disease (SD)|"Responses were assessed two months after completion of therapy.~Subjects who do not fulfill the criteria for complete or partial response as defined above but do not exhibit progressive disease will be considered as having stable disease."|2 months||||participants|||Number
2707434|NCT01191190|Secondary|IwCLL-WG Defined Partial Response (PR)|Responses were assessed two months after completion of therapy|2 months||||participants|||Number
2707435|NCT01191190|Secondary|IwCLL-WG Defined Nodular Partial Response (PR)|"Responses were assessed two months after completion of therapy.~Partial Response is defined as:~Greater than or equal to 50% decrease in blood absolute lymphocyte count from pre-treatment value; AND~Greater than or equal to 50% reduction in lymphadenopathy from pre-treatment value; AND~Greater than or equal to 50% reduction in splenomegaly/hepatomegaly from pre-treatment value.~In addition, patients need to have at least ONE of the following:~Neutrophils ≥ 1,500/μl or ≥ 50% improvement from pre-treatment value; AND / OR~Platelets > 100,000/μl or 50% improvement from pre-treatment value; AND / OR~Hemoglobin > 11.0 gm/dl (non-transfused) or 50% improvement from pre-treatment value."|2 months||||participants|||Number
2707436|NCT01191190|Secondary|IwCLL-WG Defined Overall Response Rate (ORR)|Responses were assessed two months after completion of therapy. Overall Response Rate (ORR) = CR + PR|2 months||||participants|||Number
2707437|NCT01191190|Primary|IwCLL-WG Defined Complete Response (CR)|"Responses were assessed two months after completion of therapy.~Criteria for complete remission is assessed with: a bone marrow biopsy and repeat CT scan (abdominal, chest and pelvis if initial was abnormal) to confirm iwCLL-WG defined CR.~iwCLL-WG Complete Response is defined as:~Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 x 109/L (4000/L).~Absence of lymphadenopathy (>1.5 cm)of physical exam; AND~No hepatomegaly and splenomegaly on physical exam; AND~Absence of constitutional symptoms; AND~Normal complete blood count as exhibited by neutrophils ≥ 1,500/μl, platelets > 100,000/μl, hemoglobin > 11.0g/dL (non-transfused), and lymphocyte count < 5,000/μl; AND~Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent"|2 months||||participants|||Number
2707438|NCT01191086|Primary|Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations||Open label treatment of up to 62 weeks|The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.|||participants|||Number
2707439|NCT01191008|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator.|Max 104 weeks|The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.|||Participants|||Number
2707440|NCT01191008|Primary|Clinical Effectiveness Rate|Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).|Max 104 weeks|The effectiveness analysis set comprised of participants that were excluded off-label uses or blank evaluation from safety analysis set.|||Percentage of participants||95% Confidence Interval|Number
2707441|NCT01191008|Primary|Number of Participants WithTreatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.|Max 104 weeks|The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.|||Participants|||Number
2707442|NCT01190891|Secondary|Global Rating of Change|The GROC questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GROC is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in other pain populations. A change in score of three rating points has been established as a clinically significant in the patients perception of quality of life. The GROC has 15 possible choices, with 0 being equal to no change and -1 to -7 indicating a negative change and +1 to +7 indicating a positive change.|1 year||||units on a scale||95% Confidence Interval|Mean
2707443|NCT01190891|Primary|Shoulder Pain and Disability Index|The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater pain and disability. It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.|1 year||||units on a scale||95% Confidence Interval|Mean
2707444|NCT01190878|Primary|Ocular Inflammation|"Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells."|15 days|Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.|||participants|||Number
2707445|NCT01190865|Secondary|Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.|"The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM).~Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, > 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT"|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|The analysis population consisted of the 8 cohorts of 3 subjects biopsied at weekly intervals over the 8-week duration of the study. It should be note that the cohort for Week 8 (Day 57) was composed of 4 subjects|||Days||95% Confidence Interval|Number
2707446|NCT01190865|Primary|Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.|The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|3 subjects were withdrawn; 2 for non-compliance and one at the subject's request. One subject, who was available to replace a subject assigned to a weekly cohort if the subject was unavailable, was assayed on Day 57 with the subjects assigned to the Week 8 cohort.|||Participants|||Count of Participants
2707447|NCT01190839|Secondary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.|Baseline up to Week 104|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.|||percentage of participants|||Number
2707448|NCT01190839|Secondary|Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76|Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned one of the treatment.|||percentage of participants|||Number
2707449|NCT01190839|Primary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD] before or at Week 76 were considered to have clinical recurrence.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.|||percentage of participants|||Number
2707450|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment||||letters||Standard Deviation|Mean
2707451|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.|||participants|||Number
2707452|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.|||letters||Standard Deviation|Mean
2707488|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|4 weeks after enrollment||||participants|||Number
2707950|NCT01188369|Secondary|Pulmonary Artery Pressures (mmHg)|Invasive measurement of mean pressure in the pulmonary artery|Start of operation until end of operation, approximately 3 hours|||||||
2707453|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 26 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.|||participants|||Number
2707454|NCT01190813|Secondary|Mean Systemic Adverse Events||Enrollment through 26 weeks||||events||Standard Deviation|Mean
2707455|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707456|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707457|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707458|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707459|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707460|NCT01190813|Secondary|Mean Parent Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment||||units on a scale||Standard Deviation|Mean
2707461|NCT01190813|Secondary|Mean Child Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707462|NCT01190813|Secondary|Mean Child Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707463|NCT01190813|Secondary|Mean Child Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707464|NCT01190813|Secondary|Mean Child Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707465|NCT01190813|Secondary|Mean Child Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2707466|NCT01190813|Secondary|Mean Child Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment||||units on a scale||Standard Deviation|Mean
2707467|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||letters||Standard Deviation|Mean
2707489|NCT01190813|Secondary|Mean Amblyopic Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||letters||Standard Deviation|Mean
2707490|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity at 18 Weeks||18 weeks after enrollment||||participants|||Number
2707951|NCT01188369|Secondary|Pulmonary Artery Pressures (mmHg)|Invasive measurement of mean pressure in the pulmonary artery|1 hour before operation until start of operation|||||||
2707468|NCT01190813|Primary|Mean Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.~Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.|||letters||Standard Deviation|Mean
2707469|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||participants|||Number
2707470|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||letters||Standard Deviation|Mean
2707471|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 18 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 18 weeks after enrollment, adjusted for baseline acuity.|18 weeks after enrollment||||participants|||Number
2707472|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 26 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment||||letters||Standard Deviation|Mean
2707473|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment||||participants|||Number
2707474|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 16 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment||||letters||Standard Deviation|Mean
2707475|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 16 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment||||participants|||Number
2707476|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment||||letters||Standard Deviation|Mean
2707477|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment||||participants|||Number
2707478|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.|4 weeks after enrollment||||letters||Standard Deviation|Mean
2707479|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|4 weeks after enrollment||||participants|||Number
2707480|NCT01190813|Secondary|Amblyopia Resolution at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|26 weeks after enrollment||||participants|||Number
2707481|NCT01190813|Secondary|Amblyopia Resolution at 18 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|18 weeks after enrollment||||participants|||Number
2707482|NCT01190813|Secondary|Amblyopia Resolution at 16 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|16 weeks after enrollment||||participants|||Number
2707483|NCT01190813|Secondary|Amblyopia Resolution at 10 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|10 weeks after enrollment||||participants|||Number
2707484|NCT01190813|Secondary|Amblyopia Resolutionat 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|4 weeks after enrollment||||participants|||Number
2707485|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|26 weeks after enrollment||||participants|||Number
2707491|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|18 weeks after enrollment|The analysis followed the intent-to-treat principle. For missing primary outcome visits (±1 wk), data from a visit 14-27 wks after randomization were used, if available.Multiple imputation(Monte Carlo Markov Chain method) was used for missing 18-wk VA outcomes based on treatment group, baseline VA, and VA scores from completed follow-up visits|||participants|||Number
2707492|NCT01190813|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.~Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.|||participants|||Number
2707493|NCT01190566|Secondary|Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography||Baseline, post-1st chemotherapy||||unitless||Standard Deviation|Mean
2707494|NCT01190566|Secondary|Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy|Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.|Baseline, post-1st chemotherapy|Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants.|||unitless||Standard Deviation|Mean
2707495|NCT01190566|Secondary|Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)||Baseline, post-1st chemotherapy||||unitless||Standard Deviation|Mean
2707496|NCT01190566|Secondary|Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)||Baseline, post-1st chemotherapy||||min-1||Standard Deviation|Mean
2707497|NCT01190566|Secondary|Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)||Baseline, post-1st chemotherapy||||min-1||Standard Deviation|Mean
2707498|NCT01190566|Secondary|Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)|Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.|Baseline, post-1st chemotherapy||||% of voxels||Standard Deviation|Mean
2707499|NCT01190566|Secondary|Tumor Volume|Tumor volume measured on 3-dimensional magnetic resonance imaging|Baseline, post-1st chemotherapy||||cm3||Standard Deviation|Mean
2707500|NCT01190566|Secondary|Tumor Size|Maximal tumor diameter measured on magnetic resonance imaging|baseline, completion of 1st cycle of chemotherapy||||cm||Standard Deviation|Mean
2707501|NCT01190566|Primary|Patholocial Response to Chemotherapy|Pathological complete response (pCR) or non-pCR|Post-operation||||participants|||Number
2707502|NCT01190527|Secondary|The Number of Participants That Experience Lung Toxicity and Esophagitis|The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.|2 years||||participants|||Number
2707503|NCT01190527|Secondary|Percentage of Patients Alive at 2 Years|Overall survival of all patients will be estimated|2 years||||percentage of patients||95% Confidence Interval|Number
2707504|NCT01190527|Secondary|Number of Patients That Were Able to Receive Dose Escalation|The number of patients for which dose escalation was possible will be reported.|2 Years||||participants|||Number
2707505|NCT01190527|Primary|2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)|Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.|2 years||||percentage of patients||95% Confidence Interval|Number
2707506|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Mean
2707507|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Mean
2707508|NCT01190514|Secondary|Terminal Elimination Half-life (t 1/2)|Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.|||hours||Standard Deviation|Mean
2707509|NCT01190514|Primary|Maximum Plasma Concentration (Cmax)|Cmax measured as nanograms divided by milliliters (ng/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Mean
2707510|NCT01190514|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.|||hours||Full Range|Median
2707511|NCT01190514|Primary|Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Mean
2707512|NCT01190475|Secondary|Measure: To Evaluate the Pharmacokinetic Profile of BGS649 Following Multiple Dosing at Two Dose Levels Over 3 Months in Pre-menopausal Women With Moderate to Severe Endometriosis.||8 months (Assess PK profile from first dosing through end of study and compare PK on Day 1 of first dose to that of third month)|||||||
2707513|NCT01190475|Primary|Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger|Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.|8 months|Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger|||Participants|||Count of Participants
2707514|NCT01190449|Secondary|Median Progression-free Survival Time|The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis.|From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years|Patients who completed the study and were not ineligible were included in this analysis.|||years||95% Confidence Interval|Median
2707515|NCT01190449|Primary|Overall Response Rate (Complete or Partial Response) by Month 12|The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.|From baseline to month 12|Patients who completed the study and were not ineligible were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2707516|NCT01190436|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.|Baseline up to Week 12|ITT population included all participants who received at least 1 dose of study drug.|||participants|||Number
2707517|NCT01190436|Secondary|Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12|The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||mg/dL||Standard Deviation|Mean
2707518|NCT01190436|Primary|Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12||Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2707519|NCT01190436|Secondary|Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12|The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||mg/dL||Standard Deviation|Mean
2707520|NCT01190436|Secondary|Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12|Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2707521|NCT01190436|Primary|Mean Change From Baseline in Heart Rate at Week 12|The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||beats per minute (bpm)||Standard Deviation|Mean
2707522|NCT01190436|Primary|Percentage of Participants With Response to Study Drug|Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2707523|NCT01190436|Primary|Percentage of Participants With Controlled BP|Controlled BP was defined as BP less than 130/80 mmHg.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2707524|NCT01190436|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12|The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.|Baseline, Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.|||mmHg||Standard Deviation|Mean
2707525|NCT01190436|Secondary|Mean Change From Baseline in HbA1c at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||Percent HbA1c||Standard Deviation|Mean
2707526|NCT01190436|Secondary|Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2707527|NCT01190410|Secondary|Percentage of Subjects in Clinical Remission|Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)|At the time of completion or termination visit (up to 298 weeks)|The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of study treatment in this study and who had at least 1 efficacy measurement after the first injection of this study.|||Percentage of particpiants|||Number
2707528|NCT01190410|Secondary|Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study|Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.|At the time of completion or termination visit (up to 298 weeks)|The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.|||Participants|||Count of Participants
2707529|NCT01190410|Secondary|Number of Subjects Who Develop Anti-nuclear Antibodies During the Study|Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.|At the time of completion or termination visit (up to 298 weeks)|The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.|||Participants|||Count of Participants
2707530|NCT01190410|Secondary|Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)|Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.|During study treatment (up to 303 weeks)|The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.|||Participants|||Count of Participants
2707531|NCT01190410|Primary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)|Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.|During study treatment (up to 303 weeks)|The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.|||Participants|||Count of Participants
2707532|NCT01190306|Primary|Change in Corneal Curvature.||6 Months|The CXL-001 study was completed but data analysis was not done. Prior to data analysis, the sponsor, Topcon, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.||||||
2707533|NCT01190306|Primary|Changes in Corneal Curvature||6MO|||||||
2707534|NCT01190267|Primary|Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 26 weeks|All participants who received at least one dose of extension study medication|||participants|||Number
2707535|NCT01190267|Primary|Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study|"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a treatment-emergent AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period."|Up to 30 weeks|All participants who received at least one dose of extension study medication|||participants|||Number
2707536|NCT01190254|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q overall score score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707559|NCT01190228|Primary|Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus <10 (1/dilution) and titers against the 4 dengue serotypes <10 (1/dilution).|Day 0 (pre-vaccination)|Serological flavivirus status at baseline was assessed in the Full Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Number of participants|||Number
2707537|NCT01190254|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707538|NCT01190254|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGAS score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707539|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study|CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58.|Baseline up to approximately Day 58|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||cumulative % of participants w/ Response|||Number
2707540|NCT01190254|Secondary|CGI-I Responders|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at the last available assessment of the study for that participant (i.e., endpoint). CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||participants|||Number
2707541|NCT01190254|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Day 56|CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included an on-treatment Day 56 value of the CGI-I score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707542|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study|A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59.|Baseline up to approximately Day 59|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||cumulative % of participants w/ Response|||Number
2707543|NCT01190254|Secondary|Total PANSS 30% Responders|A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||participants|||Number
2707544|NCT01190254|Secondary|Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder anxiety/depression factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707545|NCT01190254|Secondary|Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder hostility/excitement factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707546|NCT01190254|Secondary|Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder disorganized thoughts factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707547|NCT01190254|Secondary|Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder negative symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder negative symptoms factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707548|NCT01190254|Secondary|Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56|This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder positive symptoms factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707549|NCT01190254|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS general psychopathology subscale score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707550|NCT01190254|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56|This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive/negative subscale scores combined must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707551|NCT01190254|Secondary|Change From Baseline in PANSS Negative Subscale Score at Day 56|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS negative subscale score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707552|NCT01190254|Secondary|Change From Baseline in PANSS Positive Subscale Score at Day 56|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive subscale score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707553|NCT01190254|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56|Change from baseline in CGI-S score at Day 56 is the Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGI-S score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707554|NCT01190254|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 56 value of PANSS Total Score must be available for a participant.|||score on a scale||Standard Deviation|Mean
2707555|NCT01190228|Primary|Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine|Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.|Day 0 up to Day 14 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2707556|NCT01190228|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Year 1, 2, 3, 4, and 5 post-vaccination|Geometric mean titer ratios of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titer ratios (1/dilution)||95% Confidence Interval|Geometric Mean
2707557|NCT01190228|Primary|Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccination|Geometric mean titers of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2707558|NCT01190228|Primary|Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).|Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination|Seroprotection was assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.|||Percentage of participants|||Number
2707574|NCT01190215|Secondary|Number of Days With Any Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 - Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2707560|NCT01190228|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titer ratios (1/dilution)||95% Confidence Interval|Geometric Mean
2707561|NCT01190228|Primary|Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2707562|NCT01190228|Primary|Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Seroconversion was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Percentage of participants|||Number
2707563|NCT01190228|Primary|Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Seroprotection against JE-CV vaccine was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Percentage of participants|||Number
2707564|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707565|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707566|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Special Interest.|Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707567|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).|Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707568|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707569|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707570|NCT01190215|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination."|Within 28 days (Day 0 - Day 27) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707571|NCT01190215|Secondary|Number of Days With Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.~Grade 3 symptom = general symptom that prevented normal activity.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 - Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2707572|NCT01190215|Secondary|Number of Days With Any Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 - Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2707573|NCT01190215|Secondary|Number of Days With Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain and swelling.~Grade 3 redness/swelling = redness/swelling above 50 millimetres.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 - Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2707575|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).~Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius."|Within 7 days (Day 0 - Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707576|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.|Within 7 days (Day 0 - Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2707577|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.~Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
2707578|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.~Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707579|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||titre||95% Confidence Interval|Geometric Mean
2707580|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||titre||95% Confidence Interval|Geometric Mean
2707581|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Ratio||95% Confidence Interval|Geometric Mean
2707582|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Ratio||95% Confidence Interval|Geometric Mean
2707583|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
2707584|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707649|NCT01190098|Secondary|Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.|Range 0-20 where lower scores indicate more impairment (sleep related QOL).|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
2707585|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
2707586|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707587|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
2707588|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707589|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Titres||95% Confidence Interval|Geometric Mean
2707590|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Titres||95% Confidence Interval|Geometric Mean
2707591|NCT01190215|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Ratio||95% Confidence Interval|Geometric Mean
2707592|NCT01190215|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707593|NCT01190215|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707704|NCT01189604|Secondary|Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire|The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).|24 - 48 hours after completion of the procedure||||Units on a scale||Standard Deviation|Mean
2707594|NCT01190215|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.~Day 28 data was presented only for the Fluarix Group."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
2707595|NCT01190215|Primary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~Day 28 data were presented only for the Fluarix Group.~Titres were expressed as geometric mean antibody titre."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Titres||95% Confidence Interval|Geometric Mean
2707596|NCT01190189|Primary|Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies|Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2707597|NCT01190189|Primary|Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)|pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2707598|NCT01190189|Primary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2707599|NCT01190189|Primary|Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)|Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2707600|NCT01190176|Primary|Number of Subjects With Referral to Treatment at Month 48|If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.|At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.|||Participants|||Count of Participants
2707601|NCT01190176|Primary|Number of Subjects With Referral to Treatment at Month 36|If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.|At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.|||Participants|||Count of Participants
2707602|NCT01190176|Primary|Number of Subjects With Referral to Treatment at Month 24|If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.|At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.|||Participants|||Count of Participants
2707952|NCT01188369|Secondary|Systemic Arterial Pressure (mmHg)|Invasive measurements of arterial mean pressure|4 hours after operation until 21 hours after operation|||||||
2707603|NCT01190176|Primary|Number of Subjects With Referral to Treatment at Month 12|If a high-grade lesion was observed, the subject was referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was handled according to local medical practice within the local health care system. After treatment, the subject's participation in the study ended.|At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.|||Participants|||Count of Participants
2707604|NCT01190176|Primary|Number of Subjects With Referral to Colposcopy at Month 48|Detection was done on all subjects irrespective of their baseline HPV DNA status.|At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.|||Participants|||Count of Participants
2707605|NCT01190176|Primary|Number of Subjects With Referral to Colposcopy at Month 36|Detection was done on all subjects irrespective of their baseline HPV DNA status.|At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.|||Participants|||Count of Participants
2707606|NCT01190176|Primary|Number of Subjects With Referral to Colposcopy at Month 24|Detection was done on all subjects irrespective of their baseline HPV DNA status.|At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.|||Participants|||Count of Participants
2707607|NCT01190176|Primary|Number of Subjects With Referral to Colposcopy at Month 12|Detection was done on all subjects irrespective of their baseline HPV DNA status.|At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.|||Participants|||Count of Participants
2707608|NCT01190176|Primary|Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium."|At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.|||Participants|||Count of Participants
2707609|NCT01190176|Primary|Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium."|At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.|||Participants|||Count of Participants
2707610|NCT01190176|Primary|Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium."|At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.|||Participants|||Count of Participants
2707611|NCT01190176|Primary|Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Cervical cytology was performed using the ThinPrep PapTest by Quest Diagnostics, or another GSK designated laboratory. Cervical cells for ThinPrep cytology were collected using the sampling device provided and rinsed into a collection vial containing PreservCyt medium."|At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.|||Participants|||Count of Participants
2707650|NCT01190098|Secondary|Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4|Range 0-21, where higher scores more impairment (in terms of sleep quality).|Baseline to Visit 4 (approximately 1 - 2 months)|7 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
2707612|NCT01190176|Primary|Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48|Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.|At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 48.|||Participants|||Count of Participants
2707613|NCT01190176|Primary|Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36|Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.|At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 36.|||Participants|||Count of Participants
2707614|NCT01190176|Primary|Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24|Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.|At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 24.|||Participants|||Count of Participants
2707615|NCT01190176|Primary|Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12|Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.|At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]|The analysis was performed on the Total HPV-062 cohort, which included subjects from HPV-015 study who displayed normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 study visit, or who were pregnant at their concluding study visit, and for whom data were available at Month 12.|||Participants|||Count of Participants
2707616|NCT01190150|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Treatment-emergent AEs are summarized by total participants with TEAEs, participants with serious TEAEs, participants with TEAEs deemed by the investigator to be related to treatment, and participants who experienced TEAEs that caused permanent discontinuation from the study.|Day 1 up to week 4|The Safety Population consisted of all randomized participants who received at least one dose of tranexamic acid.|||participants|||Number
2707617|NCT01190150|Primary|Elimination Half-life (t ½)|Apparent first-order terminal elimination half life|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||hours||Standard Deviation|Mean
2707618|NCT01190150|Primary|The Ratio of AUC0-t to AUCinf|Comparison of AUC0-t to AUCinf by creating a ratio.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.|||ratio of AUC0-t / AUCinf||Standard Deviation|Mean
2707619|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.|||μg*h/mL||Standard Deviation|Mean
2707620|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.|||μg*h/mL||Standard Deviation|Mean
2707621|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg*h/mL||Standard Deviation|Mean
2707648|NCT01190098|Secondary|Change in Adverse Event Profile (AEP) From Baseline to Visit 4.|Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.|Baseline to visit 4 (approximately 1 - 2 months)|3 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
2707622|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg*h/mL||Standard Deviation|Mean
2707623|NCT01190150|Primary|Time to Maximum Concentration Level (Tmax)|Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||hours||Standard Deviation|Mean
2707624|NCT01190150|Primary|Dose-normalized Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg/mL||Standard Deviation|Mean
2707625|NCT01190150|Primary|Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg/mL||Standard Deviation|Mean
2707626|NCT01190124|Secondary|Adverse Drug Reactions|Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.|Week 48||||participants|||Number
2707627|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 48.|week 48||||cells/mm^3||Full Range|Median
2707628|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 24.|week 24||||cells/mm^3||Full Range|Median
2707629|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48||||participants|||Number
2707630|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24||||participants|||Number
2707631|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline||||participants|||Number
2707632|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 48.|Week 48||||cells/mm^3||Full Range|Median
2707633|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 24.|Week 24||||cells/mm^3||Full Range|Median
2707634|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at baseline.|Baseline||||cells/mm^3||Full Range|Median
2707635|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.|Week 48||||cells/mm^3||Full Range|Median
2707636|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.|Week 24||||cells/mm^3||Full Range|Median
2707637|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.|Baseline||||cells/mm^3||Full Range|Median
2707638|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48||||participants|||Number
2707639|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24||||participants|||Number
2707640|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline||||participants|||Number
2707641|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at baseline.|Baseline||||cells/mm^3||Full Range|Median
2707642|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|week 48||||participants|||Number
2707643|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|week 24||||participants|||Number
2707644|NCT01190124|Primary|HIV-RNA Levels|Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline||||participants|||Number
2707645|NCT01190098|Secondary|Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4|Range 0 -10 where higher scores reflect better quality of life.|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
2707646|NCT01190098|Secondary|Change in Daily Seizure Frequency From Baseline to Visit 4|Number of seizures per day.|Baseline to visit 4 (approximately 1 - 2 months)|2 subjects did not complete seizure diary at both time points.|||number of seizures per day||Inter-Quartile Range|Median
2707647|NCT01190098|Secondary|Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.|Range 0-27, where higher scores indicate more impairment (depressive symptoms)|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
2707753|NCT01189292|Secondary|Length of Hospital Stay|Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group|Difference between day of admission and day of discharge|intention to treat|||hour||Standard Deviation|Mean
2707651|NCT01190098|Secondary|Change in the Fatigue Severity Scale From Baseline to Visit 4.|Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.|Baseline to Visit 4 (approximately 1 - 2 months)|6 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
2707652|NCT01190098|Primary|Change in Epworth Sleepiness Scale Score From Baseline to Visit 4|Scale 0 - 24 Higher scores indicate more severe symptoms|Baseline and Visit 4 (approximately 1 - 2 months)||||Units on a scale||95% Confidence Interval|Mean
2707653|NCT01190085|Primary|Salivation|Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of psychophysiological responses, namely salivation changes.|approximately 30 minutes after drug administration||||gram||Standard Deviation|Mean
2707654|NCT01190085|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability.|Whether ghrelin intravenous (i.v.), as compared to saline i.v., does not significantly increase Adverse Events (AEs).|participants will be followed after the cue-reactivity experiment, an expected average of 7 days||||participants|||Number
2707655|NCT01190085|Primary|Alcohol Visual Analogue Scale (A-VAS)|"Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Visual Analogue Scale (A-VAS)].~The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in craving intensity."|approximately 30 minutes after drug administration||||units on a scale||Standard Deviation|Mean
2707656|NCT01190020|Secondary|Peak Methane Value|The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test|Baseline and 1 month||||parts per million||Standard Error|Mean
2707657|NCT01190020|Secondary|Percentage Change in the Colonic Transit Time|Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study|Baseline and 1 month|subjects who completed the study|||percent||Standard Error|Mean
2707658|NCT01190020|Secondary|Stool Frequency (Complete Spontaneous Bowel Movements)|change in mean stool frequency (delta) between baseline week and final week of study|Baseline and 1 month|subjects who completed the study|||bowel movements per week||Standard Error|Mean
2707659|NCT01190020|Primary|Change in Methane Production|Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study.|Baseline and 1 month|patients who completed the study were analyzed|||parts per million*minutes||Standard Error|Mean
2707660|NCT01190007|Secondary|Percent Change From Baseline in Apolipoprotein B at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of Apolipoprotein B||Standard Deviation|Mean
2707661|NCT01190007|Secondary|Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Ratio||Standard Deviation|Mean
2707662|NCT01190007|Secondary|Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Ratio||Standard Deviation|Mean
2707663|NCT01190007|Secondary|Percent Change From Baseline in Triglyceride (TG) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of TG||Standard Deviation|Mean
2707664|NCT01190007|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of HDL-C||Standard Deviation|Mean
2707665|NCT01190007|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of TC||Standard Deviation|Mean
2707666|NCT01190007|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of LDL-C||Standard Deviation|Mean
2707667|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment.~Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia."|||mmHg||Standard Deviation|Mean
2707668|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||mmHg||Standard Deviation|Mean
2707669|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.|||mmHg||Standard Deviation|Mean
2707670|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||mmHg||Standard Deviation|Mean
2707671|NCT01190007|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|52 weeks|The safety analysis set included all participants who took at least one dose of study drug.|||Participants|||Number
2707672|NCT01189890|Secondary|LS Mean Change From Baseline in Participant Body Weight at Week 30|Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30.|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had body weight measurements at baseline and at Week 30.|||kg||95% Confidence Interval|Least Squares Mean
2707673|NCT01189890|Secondary|Percentage of Participants With HbA1c <6.5% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||Percentage of Participants|||Number
2707674|NCT01189890|Secondary|Percentage of Participants With HbA1c <7.0% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||Percentage of Participants|||Number
2707675|NCT01189890|Secondary|LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG.|Baseline and Week 30|The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
2707676|NCT01189890|Primary|Number of Participants Discontinuing Study Treatment Due to An AE|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.|||Participants|||Number
2707677|NCT01189890|Primary|Number of Participants Experiencing An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.|||Participants|||Number
2707678|NCT01189890|Primary|Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30|Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.|Up to Week 30|All randomized participants who received at least one dose of study treatment.|||Participants|||Number
2707679|NCT01189890|Primary|Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30|Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Baseline and Week 30|The population included all randomized participants who had a baseline HbA1c, had a HbA1c at Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||Percentage of HbA1c||95% Confidence Interval|Least Squares Mean
2707953|NCT01188369|Secondary|Systemic Arterial Pressure (mmHg)|Invasive measurements of arterial mean pressure|End of operation until approx 4 hours after operation|||||||
2707680|NCT01189812|Secondary|Beck Scale for Suicide Ideation (BSS)|"The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny.~Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4"|4 weeks|||||||
2707681|NCT01189812|Secondary|Beck Hopelessness Scale (BHS)|"The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts.~Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4"|4 weeks|||||||
2707682|NCT01189812|Primary|Sheehan-Suicidality Tracking Scale (S-STS)|"The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide.~Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4."|4 weeks; from Baseline to Week 4|The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).|||Scores on a Scale (S-STSS)|Participants|Standard Deviation|Mean
2707683|NCT01189760|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|"The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: My facial lines make me look tired. The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much)."|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 3 are included.|||Percentage of participants|||Number
2707684|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|"The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: My facial lines make me look less attractive than I want to look. The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much)."|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.|||Percentage of participants|||Number
2707685|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|"The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: When I look in the mirror, my facial lines make me look older than I want to look. The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much)."|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.|||Percentage of participants|||Number
2707686|NCT01189760|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."|||Percentage of participants|||Number
2707687|NCT01189760|Secondary|Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2707688|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only those participants who were rated at least mild at Baseline are included in the analyses.|||Percentage of participants|||Number
2707689|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2707690|NCT01189760|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2707702|NCT01189604|Secondary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)||||Participants|||Number
2707691|NCT01189760|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.|||Percentage of participants|||Number
2707692|NCT01189747|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|"The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: My facial lines make me look tired The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much)."|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 3 were included.|||Percentage of participants|||Number
2707693|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|"The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: My facial lines make me look less attractive than I want to look. The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much)."|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.|||Percentage of participants|||Number
2707694|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|"The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: When I look in the mirror, my facial lines make me look older than I want to look. The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much)."|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.|||Percentage of participants|||Number
2707695|NCT01189747|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."|||Percentage of participants|||Number
2707696|NCT01189747|Secondary|Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2707697|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat participants included all randomized participants. Only participants who were rated at least mild at Baseline are included in the analyses.|||Percentage of participants|||Number
2707698|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2707699|NCT01189747|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator's Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2707700|NCT01189747|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.|||Percentage of participants|||Number
2707701|NCT01189617|Primary|"Number of Subjects With Irritation Score of 0 at Baseline and One Week"|Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.|Baseline and One Week|Full Analysis Set|||Participants|||Number
2707954|NCT01188369|Secondary|Systemic Arterial Pressure (mmHg)|Invasive measurements of arterial mean pressure|Start of operation until the end of operation, approximately 3 hours|||||||
2707705|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|4 minutes from the beginning of the maintenance period||||Participants|||Number
2707706|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|2 minutes from the beginning of the maintenance period||||Participants|||Number
2707707|NCT01189500|Secondary|Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
2707708|NCT01189500|Secondary|Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
2707709|NCT01189500|Secondary|Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
2707710|NCT01189500|Secondary|Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population: all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
2707711|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
2707712|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
2707713|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Error|Mean
2707714|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
2707715|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2707955|NCT01188369|Secondary|Systemic Arterial Pressure (mmHg)|Invasive measurements of arterial mean pressure|1 hour before operation until start of operation|||||||
2707716|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|4-hydroxy-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2707717|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
2707718|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
2707719|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Error|Mean
2707720|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
2707721|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2707722|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|N-desmethyl-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2707723|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
2707724|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
2707725|NCT01189500|Secondary|Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Deviation|Mean
2707726|NCT01189500|Secondary|Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
2707727|NCT01189500|Secondary|Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2707728|NCT01189500|Secondary|Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||liters||Standard Deviation|Geometric Mean
2707729|NCT01189500|Secondary|Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||mL/min||Standard Deviation|Geometric Mean
2707730|NCT01189500|Secondary|Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Deviation|Mean
2707731|NCT01189500|Secondary|Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
2707732|NCT01189500|Secondary|Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2707733|NCT01189500|Primary|Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR|Endoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2707734|NCT01189500|Primary|Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|Pharmacokinetic (PK) parameter analysis population: all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2707735|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."|||percentageof participants||95% Confidence Interval|Number
2707736|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2707737|NCT01189487|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.|Day 4|Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.|||percentage of participants|||Number
2707738|NCT01189487|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2707739|NCT01189487|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2707740|NCT01189461|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)|VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).|Baseline, Week 48 (End of treatment)|Full analysis set included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies participants who had BVCA score greater than 0 at baseline and 'n' signifies those who were evaluable at each specified time point.|||units on a scale||Standard Deviation|Mean
2707741|NCT01189461|Primary|Mean Total Number of Injections|Mean number of injections per participant was calculated as (number of injection administered per participant - 1)/duration of treatment. Mean number of injections administered for total participants was summarized.|Baseline up to Week 48 (End of treatment)|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||injections||Standard Deviation|Mean
2707742|NCT01189461|Secondary|Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2707743|NCT01189461|Primary|Incidence of Ocular and Non-Ocular Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Same participant may be represented in more than 1 category.|||participants|||Number
2707744|NCT01189435|Primary|To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib|in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib|2 years|||||||
2707745|NCT01189409|Secondary|Rectal Measures|The patients were asked to indicate any experience of rectal bleeding or rectal pain while on study treatment|Last 18 days of each 21 day study period|Patients who reported incidence of rectal pain or rectal bleeding at least once.|||Participants|||Count of Participants
2707746|NCT01189409|Secondary|Incidence of Cramps|The patients were asked to indicate any experience of cramps while on study treatment|Last 18 days of each 21 day study period|Patients who reported incidence of cramps at least once.|||Participants|||Count of Participants
2707747|NCT01189409|Secondary|Time (in Days) to Attain an Ideal BPS Score of Goal|"Proportion of patients in the study population estimated to reach a BPS at goal in the first period as a function of the time (in days) from day 1, presuming they were followed for 21 days and contributed a BPS score on each of those days.~Constipation was graded using the Victoria Bowel Performance Scale (BPS), a nine-point scale from -4 (constipation) to +4 (diarrhea) which has been validated for use in patients receiving palliative care."|3 weeks (ascertained at the end of period 1)|Patients with a minimum of 7 days of treatment in the first period were included in the modeling.|||Days||95% Confidence Interval|Median
2707748|NCT01189409|Secondary|Patient Preference|The patients will be asked to state which treatment period they prefer. Only assessed using patients who completed both arms of the study (n=28).|end of study (6 weeks)||||Participants|||Count of Participants
2707749|NCT01189409|Primary|Bowel Performance Scale (BPS)|Mean values of Number of Days with Satisfactory Bowel Movements Per Days of Treatment across time by treatment, derived from the mixed effects Poisson regression model. If the BPS rating on a day was -1, 0 or +1, the patient's bowel movement on that day was deemed to be satisfactory.|Last 18 days of each 21 day study period||||Ratio||Full Range|Mean
2707750|NCT01189370|Secondary|Overall Number of Participants That Had Disease Progression on Study|Disease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|26 months||||Participants|||Count of Participants
2707751|NCT01189370|Primary|Number of Participants Who Could Tolerate Each Dose Level|Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.|12 weeks||||Participants|||Count of Participants
2707752|NCT01189292|Secondary|Necessary Anesthesiological Medication|Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group|measured from beginning of anaesthesia to end of anaesthesia||||milligram||Standard Deviation|Mean
2707754|NCT01189292|Secondary|Postoperative Pain After Physical Stress|"Compare grade of pain between the treatment (dexamethasone) and the control (saline) group~Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1~before obtaining the pain rating, patients were asked to turn their heads (physical stress)"|4 and 8 hours after surgery|intention to treat analysis|||units on a scale||Standard Deviation|Mean
2707755|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug~severe nausea: repeated administration of antiemetic drugs~vomiting:...........at least one vomiting event"|8 hours after surgery|intention to treat|||participants|||Number
2707756|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug~severe nausea: repeated administration of antiemetic drugs~vomiting:...........at least one vomiting event"|4 hours after surgery|intention to treat|||participants|||Number
2707757|NCT01189292|Secondary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)~any PONV event within 48 hours after surgery~PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery (PP)|per protocol analysis|||percentage of participants||95% Confidence Interval|Number
2707758|NCT01189292|Primary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)~any PONV event within 48 hours after surgery~PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery|intention to treat analysis|||percentage of participants||95% Confidence Interval|Number
2707759|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment|Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication|||Patients|||Number
2707760|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment|Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication|||Patients|||Number
2707761|NCT01189279|Secondary|Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings|An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm.|17 Days|Safety Population: all subjects who received at least 1 dose of study medication|||Percentage of Patients|||Number
2707762|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost|Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|17 Days|Per Protocol: all subjects with no major protocol deviations|||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
2707763|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost|Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|Day 1|Per Protocol: all subjects with no major protocol deviations|||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
2707764|NCT01189266|Secondary|Levels of DNA Repair Proteins in Paraffin-embedded Blocks, Measured Via Immunohistochemistry or Western Analysis|For immunohistochemistry from tumor blocks, the intensity will be graded from 1 to 3; for Western analysis, a percentage of the intensity relative to the tumor with the highest level will be measured.|Baseline|||||||
2707765|NCT01189266|Secondary|Change in NHEJ Activity in PBMCs|Descriptive statistics will be used to summarize the biological/laboratory measures and the changes in these measures across time-points.|Baseline to up to 7 weeks|||||||
2707766|NCT01189266|Secondary|Change in H3 and H4 Acetylation Levels in PBMCs|Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.|Baseline to up to 7 weeks|||||||
2707767|NCT01189266|Secondary|Overall Survival|Time from enrollment to death or last follow-up, whichever occurs first.|2 years after study enrollment|One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.|||percent probability||95% Confidence Interval|Number
2707768|NCT01189266|Primary|Incidence of Toxicity During Maintenance Therapy|Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience|Planned 12 months of maintenance with Vorinostat|All patients enrolled on arm 1 and 2 received at least one dose of maintenance therapy. Seven patients enrolled on arm 3 did not receive maintenance therapy prior to date of removal from protocol therapy.|||Participants|||Count of Participants
2707769|NCT01189266|Primary|Incidence of Toxicity During Chemoradiation Therapy|Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience|Planned 7 weeks during chemoradiotherapy|All patients enrolled on Arm 1 and 2 received at least one dose of chemoradiation therapy. Two patients enrolled on arm 3 did not receive protocol therapy prior to date of removal from protocol therapy.|||Participants|||Count of Participants
2707770|NCT01189266|Primary|Event-Free Survival|Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.|2 years after study enrollment|One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.|||percent probability||95% Confidence Interval|Number
2707956|NCT01188369|Secondary|N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)|blood sample reflecting stretch of the atrium/ventricle|21 hours after operation until 96 hours after operation|||||||
2707771|NCT01189266|Primary|Maximum Tolerated Dose (MTD) of Vorinostat|The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy|Planned 7 weeks during chemoradiotherapy|All patients enrolled on arm 1 and 2 who received at least 85% of the planned doses of radiation therapy and chemotherapy in the chemoradiotherapy portion of the study or who experienced DLT after after receiving at least one dose of chemoradio therapy and completing 7 weeks fo follow-up.|||mg/m^2|||Number
2707772|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15. Only 4 pts samples were evaluable for AUC 24 at the10mg dose.|||ng*h/mL||Standard Deviation|Mean
2707773|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.|24hrs|Day 1|||ng*h/mL||Standard Deviation|Mean
2707774|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15 only. Level 2 10mg only had 5pts with evaluable PKs at day 15|||ng/mL||Standard Deviation|Geometric Mean
2707775|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|"all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected"|24 hrs|Day One only|||ng/mL||Standard Deviation|Geometric Mean
2707776|NCT01189240|Secondary|Toxicity Description (Dose Limiting Toxicity-DLT) of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort. Pts must receive one dose of treatment to be evaluated for toxicity. Toxcity description associated with combination of RO4929097 and Bevacizumab|28 days - 1 cycle|DLT Defintion, must be related to RO and/or Bev: ANC </= 500/μL or second time ANC <1,000/μL; PLTs </= 25,000/μL or second time platelets <50,000/μL; Febrile neutropenia;Thrombocytopenic bleeding (platelets <50,000/μL and with clinically significant bleeding); Delay of treatment > 14 days ;grade 3 or 4 non-hematological toxicity (some exceptions)|||participants|||Number
2707777|NCT01189240|Primary|Maximum-tolerated Dose and the Recommended Phase II Dose of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab Determined by Dose-limiting Toxicity Rate (Phase I)|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used|28 days|RO4929097 Days 1-3 weekly (doses 5,10, 20 mg) + Bev 10mg/kg IV q2 wks - cycle 28 days. 3+3 dose escalation method will be used. Target DLT is > or equal to 33%|||mg|||Number
2707778|NCT01189227|Secondary|Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0||From study entry through 3 months after the last treatment dose.|||||||
2707779|NCT01189227|Secondary|Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery||Assessed within 30 days from the time of surgery|||||||
2707780|NCT01189227|Secondary|The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.||Assessed at the time of surgery|||||||
2707781|NCT01189227|Secondary|Overall Survival||From study entry until the time of death or for a maximum of 5 years.|||||||
2707782|NCT01189227|Secondary|RFS of Patients Event-free||From study entry until the date of recurrence or for a maximum of 6 months.|||||||
2707783|NCT01189227|Primary|Recurrence-free Survival (RFS)|Time to recurrence or death|From study entry until the date of recurrence or death or for a maximum of 5 years.|||||||
2707784|NCT01189201|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.|Drug administration until next treatment period/end-of-study examination, up to 36 days|Treated set (TS) included all subjects who were documented to have taken at least one dose of investigational treatment.|||participants|||Number
2707785|NCT01189201|Primary|Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707786|NCT01189201|Primary|Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2707787|NCT01189201|Secondary|Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707788|NCT01189201|Primary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707789|NCT01189201|Primary|Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2707790|NCT01189201|Secondary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707791|NCT01189201|Primary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707792|NCT01189201|Primary|Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2707793|NCT01189201|Secondary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707794|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707818|NCT01188967|Primary|4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)|Week 8 of the study|9 participants completed this visit|||Participants|||Count of Participants
2707795|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2707796|NCT01189201|Secondary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707797|NCT01189201|Secondary|Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707798|NCT01189201|Secondary|Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707799|NCT01189201|Secondary|Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of linagliptin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Full Range|Median
2707800|NCT01189201|Secondary|Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Full Range|Median
2707801|NCT01189201|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2707802|NCT01189201|Primary|Empagliflozin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2707803|NCT01189201|Primary|Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707850|NCT01188681|Secondary|Response Per NCI Criteria|Overall response rate per National Cancer Institute (NCI) Working group criteria.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Safety data for all patients who received any study drug and efficacy data for randomized patients who received some study treatment and have some post baseline data are presented here.|||percentage of patients|||Number
2707804|NCT01189201|Primary|Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2707805|NCT01189136|Other Pre-specified|Pain From Treatment|Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)|30 minutes||||units on a scale||Standard Deviation|Mean
2707806|NCT01189136|Other Pre-specified|Questionnaire Data - Impression of Allocation|"Participants were asked to guess to which treatment arm they had been allocated (PTNS Sham or I Don't Know). Outcome was measured as the number of patients in each arm accurately determining their allocation."|30 minutes|Number|||number of participants|||Number
2707807|NCT01189136|Secondary|Amount of Improvement in Voiding Efficiency|Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm.|30 minutes||||percentage of voided vol/total volume||Standard Deviation|Mean
2707808|NCT01189136|Primary|Persistent Retention|Number of participants with persistent unsuccessful trial of void after the intervention|30 minutes||||participants|||Number
2707809|NCT01189123|Secondary|Antibody Responses|Hemagglutination inhibition antibody titers measured for standard vs high dose|2 years||||GMT||95% Confidence Interval|Geometric Mean
2707810|NCT01189123|Primary|Cellular Immune Response|comparison of CMI in high vs standard dose|3 years|A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled.|||percentage of Stimulated cells||Inter-Quartile Range|Median
2707811|NCT01189110|Primary|Percentage of Self-reported Abstinence at 6 Weeks.|Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).|6 weeks|A middle-aged, US military veteran population not free of smoking (at least 10 cigarettes per day) and not currently in reciept of any other form of smoking cessation intervention.|||percentage of participants||95% Confidence Interval|Number
2707812|NCT01189071|Secondary|Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.|"Decreased use of narcotic and anticholinergic medication use postoperatively, compared to the standard of care patient"|end of study with 30 patients recruited|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.||||||
2707813|NCT01189071|Primary|Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty|"Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the standard of care patient with no preop Darifenacin"|24 months|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.||||||
2707814|NCT01189032|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.~The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued(LOCF))|"Efficacy analysis was performed per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).~The reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data."|||points||Standard Deviation|Mean
2707815|NCT01188967|Secondary|Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications|"The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo two weeks after discontinuation of double blind study medications.~7-day, Point-prevalence tobacco abstinence was defined as not smoking for the 7 consecutive days before this visit after discontinuation of double blind study medications"|Week 10 of the study|7 participants completed this visit.|||Participants|||Count of Participants
2707816|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of 6 weeks exposure to GSK598809/placebo.|Week 8 of the study|7 participants completed week 6 weeks exposure to GSK598809/placebo.|||Participants|||Count of Participants
2707817|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of the first week of exposure to GSK598809/placebo.|Week 3 of the study|13 participants completed week 1 visit|||Participants|||Count of Participants
2707819|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 8|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 8 weeks||||percentage of change in PASI||Standard Deviation|Mean
2707820|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 4|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 4 weeks||||percentage of change in PASI||Standard Deviation|Mean
2707821|NCT01188928|Primary|Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|week 8||||participants|||Number
2707822|NCT01188928|Primary|Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|4 weeks||||participants|||Number
2707823|NCT01188876|Secondary|Area Under the Plasma Drug Concentration-Time Curve (AUC)|Area under the plasma drug concentration-time curve (AUC) for phase 1 participants that were dosed at 105 mg/m2. AUC represents the actual body exposure to drug after administration of a dose of the drug and is expressed in micrograms * hour per milliliter (ug*h/mL).|Day 1 and Day 15|Participants that required a dose reduction due to an adverse event were excluded from the day 15 evaluation|||ug*h/mL||95% Confidence Interval|Mean
2707824|NCT01188876|Secondary|Maximum Concentration of Drug in Plasma (Cmax)|The maximum concentration of Pralatrexate at day 1 and 15 among phase 1 participants dosed at 105 milligrams per square meter of body surface area (mg/m2). The concentration is given in micrograms per milliliter.|Day 1 and Day 15|Participants that required a dose reduction due to an adverse event were excluded from the day 15 evaluation|||ug/ml||95% Confidence Interval|Mean
2707825|NCT01188876|Secondary|Treatment Related Adverse Events|Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4). Adverse events were assessed from the start of treatment until 30 days after the last dose of study drug.|1 Year||||Participants|||Count of Participants
2707826|NCT01188876|Secondary|Progression Free Survival|The number of participants alive and without disease progression at the given time-points. Time is measured from the start of treatment. Progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3 months, 6 months||||Participants|||Count of Participants
2707827|NCT01188876|Secondary|Overall Survival|The number of participants still alive at the given time points. The duration of time is measured from the start of treatment until death due to any cause, participants are censored at the date of the last evaluation. The number participants surviving at 6, 12, 18, and 24 months is shown.|6, 12, 18, and 24 months||||Participants|||Count of Participants
2707828|NCT01188876|Primary|Best Overall Response|"Summary of the best overall responses to treatment as assessed by RECIST (Response Evaluation Criteria In Solid Tumors).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|1 Year||||Participants|||Count of Participants
2707829|NCT01188876|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose of Pralatrexate in combination with Carboplatin in this patient population. The unit is given in milligrams per square meter of body surface area. MTD was determined using a standard 3 + 3 dose escalation cohort, where 3 participants were enrolled on the starting dose of 30 mg/m2 and if no dose limiting toxicities (DLT) were experienced after a full cycle, 3 additional participants were enrolled at the next highest dose level. Each increase in dose level escalated the dose of Pralatrexate by 15 mg/m2. If during any dose level, 1 patient out of 3 develops a DLT, then 3 additional patients will be added to that dose level. If 2 out of the 3 patients placed on any dose level experience a DLT, the preceding dose is considered MTD. If 1/6 has a DLT, the next higher dose level will commence accrual (unless at level +5 and then accrual to the Phase I portion will stop). If ≥ 2 of 6 patients have a DLT, then the preceding dose will be considered MTD.|1 year|The participants that participated in the phase 1 dose escalation portion of the study|||mg/m^2|||Number
2707830|NCT01188811|Secondary|Safety Measure: Adverse Events||adverse events recorded from baseline to year 2|Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group.|||occurences|||Number
2707831|NCT01188811|Secondary|Disability Measures: Mobility||Change in Timed 25 Foot Walk from baseline to year 2|Outliers were removed and intention-to-treat analysis was performed on data from 21 participants in the lipoic acid group and 17 in the placebo group.|||seconds||Standard Deviation|Mean
2707832|NCT01188811|Primary|Brain Atrophy by MRI||% change brain volume from baseline to year 2|22 subjects in the lipoic acid group and 24 in the placebo group completed the MRI outcome. Two outliers in the lipoic acid group were not included in analysis.|||whole brain percent volume change||Standard Deviation|Mean
2707833|NCT01188798|Secondary|Assess Overall Survival, Relapse, Engraftment, and Regimen-related Morbidity and Estimating Cumulative Incidence of Pulmonary Adverse Events and Mucositis.|To characterize the pharmacokinetic-pharmacodynamic relationships of pentostatin in this patient population and to assess the relationship between pre-transplant minimal residual disease (MRD) and transplant outcomes.|42 days post- transplant|Insufficient data was available to answer objectives.||||||
2707904|NCT01188460|Primary|Sleep Diary- Sleep Efficiency|"Measures:~Sleep Efficiency (percentage)- higher scores indicate better outcomes"|Timepoint 2 (week 7 of study participation).||||Percentage of efficiency||Standard Deviation|Mean
2707834|NCT01188798|Primary|Determining Whether the Hepatic Adverse Event-free (NCI Grades II-IV) Survival at Day 42 After an HLA-matched Transplant for Hematologic Malignancy Can be Improved by Using a GVHD Prophylaxis Regimen That Includes Pentostatin Rather Than MTX.|The hypothesis was that individuals receiving the drug pentostatin as GVHD prophylaxis would experience less severe hepatic toxicity than those receiving methotrexate as GVHD prophylaxis. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 grade 2 or above hepatic toxicity-free survival in pentostatin recipients|42 days post-transplant|Insufficient data was available to answer objectives||||||
2707835|NCT01188772|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir|Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.|Baseline to Week 12|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.|||percentage of participants|||Number
2707836|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.|||ng•h/mL||Standard Deviation|Mean
2707837|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.|||ng•h/mL||Standard Deviation|Mean
2707838|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.|||ng•h/mL||Standard Deviation|Mean
2707839|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.|||ng/mL||Standard Deviation|Mean
2707840|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.|||ng/mL||Standard Deviation|Mean
2707841|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.|||ng/mL||Standard Deviation|Mean
2707842|NCT01188772|Secondary|Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)|SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively.|Post-treatment Weeks 12 and 24|Safety Analysis Set|||percentage of participants|||Number
2707843|NCT01188772|Secondary|Percentage of Participants With Virologic Response at the End of Treatment|End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit.|Week 48 (genotype 1) or Week 12 (genotype 2/3)|Participants in the Safety Analysis Set with available data were analyzed. One participant in the Sofosbuvir 400 mg (Genotype 2/3) Group was lost to follow up before the end of treatment and is not included in this analysis.|||percentage of participants|||Number
2707844|NCT01188772|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12.|Week 4 to Week 12|Safety Analysis Set|||percentage of participants|||Number
2707845|NCT01188772|Secondary|Percentage of Participants With Complete Early Virologic Response at Week 12|Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12|Week 12|Safety Analysis Set|||percentage of participants|||Number
2707846|NCT01188772|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29)|Week 4|Safety Analysis Set|||percentage of participants|||Number
2707847|NCT01188772|Secondary|Change in HCV RNA From Baseline to Week 12||Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2707848|NCT01188772|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 12 plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study drug|||percentage of participants|||Number
2707849|NCT01188694|Primary|PTSD Symptom Severity-Interview (PSS-I)|PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)|Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)|Intent to Treat|||units on a scale||Standard Deviation|Mean
2707851|NCT01188681|Primary|Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria|Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Treated patients|||percentage of patients|||Number
2707852|NCT01188668|Secondary|Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.|||ng/mL||Full Range|Median
2707853|NCT01188668|Secondary|Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.|||ng/mL||Full Range|Median
2707854|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
2707855|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
2707856|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||hours||Standard Deviation|Mean
2707857|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Full Range|Median
2707858|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2707859|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2707860|NCT01188668|Secondary|Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||liters||Standard Deviation|Geometric Mean
2707861|NCT01188668|Secondary|Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||mL/min||Standard Deviation|Geometric Mean
2707862|NCT01188668|Secondary|Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||hours||Standard Deviation|Mean
2707863|NCT01188668|Secondary|Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the median.|||hours||Full Range|Median
2707864|NCT01188668|Secondary|Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2707865|NCT01188668|Primary|Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2707866|NCT01188655|Secondary|Spine Agility Function by Ott Test|The Ott index determines the agility of the thoracic spine.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||cm||Standard Deviation|Mean
2707867|NCT01188655|Secondary|Spine Agility Function by Schober Test|Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||cm||Standard Deviation|Mean
2707868|NCT01188655|Secondary|Mean Occiput-to-wall Distance at Week 12 and Week 24||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||cm||Standard Deviation|Mean
2707869|NCT01188655|Secondary|Percentage of Participants Without Peripheral Arthritis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Percentage of Participants|||Number
2707870|NCT01188655|Secondary|Percentage of Participants Without Enthesitis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Percentage of Participants|||Number
2707871|NCT01188655|Secondary|Change From Baseline in ASQoL at Week 12 and Week 24|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Units on a scale||Standard Deviation|Mean
2707872|NCT01188655|Secondary|Mean Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||minutes||Standard Deviation|Mean
2707873|NCT01188655|Secondary|Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||mm||Standard Deviation|Mean
2707874|NCT01188655|Secondary|Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24|Measured using a 100mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Units on a scale||Standard Deviation|Mean
2707905|NCT01188460|Primary|Sleep Diary- Number of Nocturnal Awakenings|"Measures:~Number of Nocturnal Awakenings, higher scores indicate worse outcomes"|Timepoint 2 (week 7 of study participation).||||Number of nocturnal awakenings||Standard Deviation|Mean
2707906|NCT01188460|Primary|Sleep Diary- Time to Fall Asleep|"Measures:~Time to Fall Asleep in minutes, higher scores indicate worse outcomes"|Timepoint 2 (week 7 of study participation).||||minutes||Standard Deviation|Mean
2707875|NCT01188655|Secondary|Change From Baseline in the BASFI at Weeks 12 and 24|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Units on a scale||Standard Deviation|Mean
2707876|NCT01188655|Secondary|Change From Baseline in BASDAI at Week 12 and 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||units on a scale||Standard Deviation|Mean
2707877|NCT01188655|Primary|Percentage of Participants Achieving BASDAI 40 Response at Week 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.|Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||Percentage of participants|||Number
2707878|NCT01188603|Primary|Flibanserin: Tmax,ss|Median of the tmax,ss of Flibanserin|8 days|All patients with values for the time from dosing to the maximum measured concentration of flibanserin in plasma after single dose at steady state (tmax,ss)|||h||Full Range|Median
2707879|NCT01188603|Primary|Flibanserin: Cmax,ss|Geometric mean of the Cmax,ss of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2707880|NCT01188603|Primary|Flibanserin: Cmax (Peak Concentration)|Geometric mean of the Cmax of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2707881|NCT01188603|Primary|Flibanserin: AUC τ,ss|Geometric mean of the AUC τ,ss of Flibanserin|8 days|All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2707882|NCT01188603|Primary|Flibanserin: Area Under the Curve; AUC_0-∞|Geometric mean of the AUC_0-∞ of Flibanserin|8 days||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2707883|NCT01188577|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
2707884|NCT01188577|Primary|Half-life (t1/2) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Full Range|Mean
2707885|NCT01188577|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Standard Deviation|Mean
2707886|NCT01188577|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg*min/mL||Standard Deviation|Mean
2707907|NCT01188460|Primary|Sleep Diary- Total Sleep Time|"Measures:~Total Sleep Time in hours, higher scores indicate better outcomes"|Timepoint 2 (week 7 of study participation).||||hours||Standard Deviation|Mean
2707887|NCT01188577|Primary|Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
2707888|NCT01188577|Primary|Baseline Concentration (C0) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurement btwn 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
2707889|NCT01188564|Secondary|Time to Minimal Symptoms|"The key secondary efficacy endpoint was the time to minimal symptoms at all locations. The time to achieving minimal symptoms was defined as an answer of Yes to TEQ question 3."|24 hours||||minutes||Full Range|Median
2707890|NCT01188564|Primary|Time to Beginning of Relief of Symptoms|"Time to beginning of relief is the time lapsed from the beginning of the infusion of study medication to the beginning of a beneficial effect based on patient's responses to the Treatmetn Effect Questionnaire (TEQ) for the primary attack location. The beginning of relief is defined as the first timepoint at which~The patient reports any of the following answers for TEQ question 1: A little better, Better or Much better; and;~The patient reports the following answer for TEQ question 2: Yes; and,~There is persistence in improvement at the next assessment time, i.e.either the same or a better response to Question 1 and Yes to Question 2."|Patients observed for 24 hours||||minutes||95% Confidence Interval|Median
2707891|NCT01188551|Secondary|Recovery From General Anesthesia|Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.|30 mins. post-op||||units on a scale||Standard Deviation|Mean
2707892|NCT01188551|Primary|FLACC Behavioral Pain Assessment Scale Scores|"FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.~0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both"|30 mins. post-op||||units on a scale||Standard Deviation|Mean
2707893|NCT01188538|Secondary|Percent Change (%) in Inflammatory Lesion Counts|Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.|Week 12|ITT (LOCF)|||Percent change (%)||Full Range|Median
2707894|NCT01188538|Primary|Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes|"Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.~Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study."|Week 12|Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)|||Log10 cfu/cm²||Standard Deviation|Mean
2707895|NCT01188499|Secondary|Evaluation of Pharmacokinetics and Translational Biomarkers|Measurement of TL32711 pharmacokinetics: Maximum plasma concentration (Cmax), area under the curve (AUC), half-life (t1/2) and assessment of translational biomarkers in plasma, PBMC's and tumor biopsies. Gene expression profiling of tumor tissue.|Cycle 1 and Cycle 2|||||||
2707896|NCT01188499|Secondary|Evaluation of Anti-tumor Efficacy|Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST) and time to progression|Every 2 cycles|Intent-to-treat (ITT)|||participants|||Number
2707897|NCT01188499|Primary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability|Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters|1 Cycle (3-4 weeks)||||participants|||Number
2707898|NCT01188460|Secondary|Fatigue Severity Scale (FSS)|Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
2707899|NCT01188460|Secondary|Pre-Sleep Arousal Scale (PSAS)|Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
2707900|NCT01188460|Secondary|Hospital Anxiety and Depression Scale (HADS)|Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
2707901|NCT01188460|Secondary|Pain Disability Index (PDI)|Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
2707902|NCT01188460|Secondary|Pain Severity Rating|Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
2707903|NCT01188460|Primary|Sleep Diary- Sleep Quality|"Measures:~Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes"|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
2707909|NCT01188447|Secondary|Average Contact Time|Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)|immediately following evaluation|In order to be included in this analysis, and to have Contact Time calculated, both the paramedic arrival time and transfer of care time were required. Any case missing this information could not be included in the calculation.|||minutes||Full Range|Mean
2707910|NCT01188447|Secondary|Scene Time|Time spent at scene (difference between Paramedic scene departure and arrival at patient side)|immediately following evaluation|In order to be included in this analysis, a valid time for paramedic arrival and paramedic scene departure were required. Any patient refusing transport or missing time information was not included in the analysis.|||Minutes||Full Range|Mean
2707911|NCT01188447|Secondary|Performance of the Canadian C-Spine Rule|"Measurements of the performance of the rule will include:~rule accuracy~paramedic accuracy of interpretation~paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule"|Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.||||percentage of injuries identified||95% Confidence Interval|Number
2707912|NCT01188447|Secondary|Clearance Rate|Proportion of eligible low-risk patients transported without immobilization|Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit||||Participants|||Count of Participants
2707913|NCT01188447|Primary|Adverse Events|"Measures of safety will include:~number of missed cervical spine injuries~number of serious adverse outcomes"|within 30 days of enrollment||||Adverse event|||Number
2707914|NCT01188421|Primary|Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.|Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.|14 days total|Repeated measures ANOVA|||units on a scale||Standard Error|Mean
2707915|NCT01188369|Secondary|Urine Clearance|Urine analysis. Measure of kidney function.|from start of operation until 24 hours after operation|||||||
2707916|NCT01188369|Secondary|E/A-ratio (Transoesophageal)|Transoesophageal echocardiographic measure of diastolic heart function|from end of operation until approximately 4 hours after operation|||||||
2707917|NCT01188369|Secondary|E/A-ratio (Transoesophageal)|Transoesophageal echocardiographic measure of diastolic heart function|from start of operation until end of operation, approximately 3 hours|||||||
2707918|NCT01188369|Secondary|Inflammatory Parameters|Blood sample values of pro- and antiinflammatory mediators|21 hours after operation until 96 hours after operation|||||||
2707919|NCT01188369|Secondary|Inflammatory Parameters|Blood sample values of pro- and antiinflammatory mediators|4 hours before operation until 21 hours after operation|||||||
2707920|NCT01188369|Secondary|Cardiac Index (l/Min/m2)|Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)|4 hours after operation until 21 hours after operation|||||||
2707921|NCT01188369|Secondary|Cardiac Index (l/Min/m2)|Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)|End of operation operation until approx. 4 hours after operation|||||||
2707922|NCT01188369|Secondary|Cardiac Index (l/Min/m2)|Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)|Start of operation until end of operation, approximately 3 hours|||||||
2707923|NCT01188369|Secondary|Cardiac Index (l/Min/m2)|Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)|1 hour before operation until start of operation|||||||
2707924|NCT01188369|Secondary|Isovolumetric Relaxation Time (IVRT) (s)|Transeosophageal echocardiography: Time from closure of aortic valve to opening of mitral valve. Measure of diastolic function.|End of operation until approx. 4 hours after operation|||||||
2707925|NCT01188369|Secondary|Ejection Fraction (Per Cent)|Transeosophageal echocardiography: Measure of systolic function|End of operation until approx. 4 hours after operation|||||||
2707926|NCT01188369|Secondary|Isovolumetric Relaxation Time (IVRT) (s)|Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function|96 hours after operation until 6 months after operation|||||||
2707927|NCT01188369|Secondary|Isovolumetric Relaxation Time (IVRT) (s)|Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function|21 hours after operation until 96 hours after operation|||||||
2707928|NCT01188369|Secondary|Isovolumetric Relaxation Time (IVRT) (s)|Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function|1 hour before operation until 21 hours after operation|||||||
2707929|NCT01188369|Secondary|E'/A'-Ratio (Unitless)|Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.|96 hours after operation until 6 months after operation|||||||
2707930|NCT01188369|Secondary|E'/A'-Ratio (Unitless)|Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.|21 hours after operation until 96 hours after operation|||||||
2707931|NCT01188369|Secondary|E'/A'-Ratio (Unitless)|Tissue Doppler transthoracic echocardiography: Ratio between tissue velocities at the mitral plan during early (E) diastole and late (A) diastole. Index of diastolic function.|1 hour before operation until 21 hours after roperation|||||||
2707932|NCT01188369|Secondary|E/A-ratio (Unitless)|Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.|96 hours after operation until 6 months after operation|||||||
2707933|NCT01188369|Secondary|E/A-ratio (Unitless)|Transthoracic echocardiographic ratio between early (E) and late (A) transmitral blood velocities. Index of diastolic function.|21 hours after operation until 96 hours after operation|||||||
2707963|NCT01188369|Secondary|E/A Ratio (Unitless)|TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus|At the end of operationon until approx 4 hours after operation|||||||
2707964|NCT01188369|Secondary|Regional Longitudinal Strain (Unitless)|Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.|Froml the end of operation until approx 4 hours after operation|||||||
2707965|NCT01188369|Secondary|Ejection Fraction (Per Cent)|TTE: Index of systolic function|96 hours after operation until 6 months after operation|||||||
2707966|NCT01188369|Secondary|Ejection Fraction (Per Cent)|TTE: Index of systolic function|21 hours after operation until 96 hours after start of operation|||||||
2707967|NCT01188369|Secondary|Ejection Fraction (Per Cent)|TTE: Index of systolic function|1 hour before until 21 hour after start of operation|||||||
2707968|NCT01188369|Secondary|Regional Longitudinal Strain (Unitless)|Index of systolic function derived from single transthoracic echocardiographic (TTE) projection|4 hours before until 1 hour before start of operation|||||||
2707969|NCT01188369|Secondary|No. of Patients With Adverse Event|Occurence of headache|4 hours before operation until approximately 1 hour before operation|||||||
2707970|NCT01188369|Secondary|No. of Patients With Adverse Event.|Occurence of nausea|4 hours before operation until 1 hour before operation|||||||
2707971|NCT01188369|Secondary|No. of Patients With Adverse Event|Need for norepinephrine as an antagonist to the vasodilatatory effect of levosimendan|4 hours before operaton until 1 hour before operaton|||||||
2707972|NCT01188369|Secondary|No. of Patients With Adverse Event|Development of atrial flutter/fibrillation|-4 hours until + 96 hours with respect to start of operation|||||||
2707973|NCT01188369|Secondary|No. of Patients With Adverse Events|Development of Ventricular tachycardia|-4 hours until + 96 hours with respect to start of operation|||||||
2707974|NCT01188369|Secondary|Postoperative Admission Time at Intensive Care Unit (Hours)|Total admission time in the intensive care after operation|From admission to the intensive care unit until discharge from intensive care unit, approximately 24 hours|||||||
2707975|NCT01188369|Secondary|Intubation Time (Minutes)|Total time intubated including time of operation and in the intensive care ward|From intubation until extubation, approximately 6 hours|||||||
2707976|NCT01188369|Secondary|Time on Heart-lung Machine (Minutes)||From time of cardioplegia until selfsufficient cardiac action, approximately 1 hour|||||||
2707977|NCT01188369|Secondary|Operation Time (Minutes)||"From knife start until knife end, approximately 3 hours"|||||||
2707978|NCT01188369|Secondary|Intravenous Fluid Requirement (l)|Total volume of intravenous fluid required including blood products.|Within 24 hours from start of operation|||||||
2707979|NCT01188369|Secondary|Need for Conventional Inotropical Agents|Conventional inotropics are comprised of all inotropics acting primarily through alfa- or beta- stimulation.|From start of operation until 5 days after operation|||||||
2707980|NCT01188369|Secondary|Regional Longitudinal Strain (Unitless)|Transoesophageal echocardiographic (TEE) measure of systolic function. At this time not validated properly against acknowledged indices of systolic function.|At the start of operation until the end of operation, approximately 3 hours|||||||
2707981|NCT01188369|Secondary|E/A Ratio (Unitless)|TEE ratio between early (E) transmitral flow and late (A) transmitral flow. An index of diastolic function althought not validated properly yet when measured from the oesophagus|At the start of operation until the end of operationon, approximately 3 hours|||||||
2707982|NCT01188369|Secondary|Mixed Venous Oxygenation (Per Cent)|Oxygen content (per cent of hemoglobin saturated) of venous blood in pulmonary artery|4 hours before operation until 4 hour after operation|||||||
2707983|NCT01188369|Secondary|Lactate (mmol/l)|Arterial sampling of blood lactate|4 hours before operation until 4 hour after operation|||||||
2707984|NCT01188369|Secondary|Troponin T (ug/l)|Blood sample expressing damage to the myocytes|4 hours before operation until 4 hours after operation|||||||
2707985|NCT01188369|Secondary|N-terminal Pro Brain Natriuretic Peptide (NT proBNP)(pg/ml)|blood sample reflecting stretch of the atrium/ventricle|4 hours before operation until 4 hours after operation|||||||
2707986|NCT01188369|Secondary|Systemic Arterial Pressure (mmHg)|Invasive measurements of arterial mean pressure|4 hours before operation until 1 hour before operation|||||||
2707987|NCT01188369|Secondary|Pulmonary Artery Pressures (mmHg)|Invasive measurement of mean pressure in the pulmonary artery|4 hours before operation until 1 hour before operation|||||||
2707988|NCT01188369|Secondary|Central Venous Pressure (mmHg)|Invasive measurement of pressure in the vena cava|4 hours before operation until 1 hours before operation|||||||
2707989|NCT01188369|Secondary|Cardiac Index (l/Min/m2)|Invasive measurement measuring the cardiac output divided by calculated body surface area (DuBois formula)|4 hours before operation until 1 hour before operation|||||||
2707990|NCT01188369|Secondary|Ejection Fraction (Per Cent)|Transeosophageal echocardiography: Measure of systolic function|At start of operation until end of operation, approximately 3 hours|||||||
2707991|NCT01188369|Secondary|Isovolumetric Relaxation Time (IVRT) (s)|Transthoracic measure of the time from aortic valve closure until mitral valve opening. A measure of diastolic function|4 hours before surgery until 1 hour before operation|||||||
2707992|NCT01188369|Primary|E/E'(Unitless)|Ration between early transmitral flow (E) and mitral annular tissue velocity(E'). This ratio is an echocardiographic index of diastolic function|4 hours before operation until 21 hour after operation||||Unitless||Full Range|Median
2708001|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2707993|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.|||Participants|||Number
2707994|NCT01188343|Other Pre-specified|Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil).|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Full Analysis Set.|||Participants|||Number
2707995|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.|||Participants|||Number
2707996|NCT01188343|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).|Pre-vaccination and Day 42 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.|||Titers||95% Confidence Interval|Geometric Mean
2707997|NCT01188343|Secondary|Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m|Pre-vaccination and up to Month 12 post-vaccination|Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.|||Participants|||Number
2707998|NCT01188343|Secondary|Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m|Pre-vaccination and Day 42 post-vaccination|Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).|||Percentage of Participants|||Number
2707999|NCT01188343|Primary|Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.|Day 0 (pre-vaccination) and Day 42 post-vaccination|Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.|||Percentage of Participants|||Number
2708000|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708032|NCT01187771|Secondary|Mean 24-hour Systolic Blood Pressure||9 months||||mmHg||Standard Deviation|Mean
2708002|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708003|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708004|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708005|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708006|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|24 months after denture completion|For study participants who completed the 24-month follow-up.|||participants|||Number
2708007|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|18 months after denture completion|For study participants who completed the 18-month follow-up.|||participants|||Number
2708008|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)|12 months after denture completion|For study participants who completed the 12-month follow-up.|||participants|||Number
2708009|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708010|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708011|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|6 months after denture completion||||participants|||Number
2708012|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|24 months after denture completion|For study participants who completed the 24-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 24-month lower-denture assessment|||participants|||Number
2708013|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|18 months after denture completion|For study participants who completed the 18-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 18-month lower-denture assessment|||participants|||Number
2708014|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|12 months after denture completion|For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.|||participants|||Number
2708015|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal).|6 months after denture completion|For study participants who completed the 6-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
2708033|NCT01187771|Primary|Epworth Sleepiness Score|The Epworth Sleepiness Scale results in scores ranging from 0-24, where scores of 0-10 indicate normal levels of sleepiness while 11-24 indicate excessive daytime sleepiness.|9 months||||Units on Epworth Sleepiness scale||Standard Deviation|Mean
2708034|NCT01187771|Primary|Effective Apnea Hypopnea Index|The Effective Apnea Hypopnea Index (AHI) is the actual frequency of apneas and hypopneas per hour that the patient is exposed to. It is calculated as the AHI while on CPAP times the proportion of sleep time that CPAP was used plus the AHI off CPAP times the proportion of sleep time that CPAP is not used.|9 months||||Events per hour||Standard Deviation|Mean
2708016|NCT01188109|Secondary|Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression|To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1-10%; 2 = 11-50%; 3 = 51-100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression.|At the time of resection|Twenty patients had tissue available for ERCC1 analysis.|||patients|||Number
2708017|NCT01188109|Primary|Recurrence-free Survival as Measured by CT Scan|Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.|Every 3 months and then every 6 months for 2 more years after resection||||months||95% Confidence Interval|Median
2708018|NCT01187953|Secondary|For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period (day 1 to day 734): death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|734 days|All 543 randomized patients were included in the analysis population.|||participants|||Number
2708019|NCT01187953|Primary|The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|360 days|All 543 randomized patients were included in the analysis population.|||participants|||Number
2708020|NCT01187914|Primary|Left Atrial (LA) Remodeling Pre-ablation|Utah staging for fibrosis (I - <=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - >=35.01%)|Once pre-ablation||||participants|||Number
2708021|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.|||polyps||Inter-Quartile Range|Median
2708022|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Classic FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both|||polyps||Inter-Quartile Range|Median
2708023|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count).|Baseline and 6 months||||polyps||Inter-Quartile Range|Median
2708024|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.|||mm||Inter-Quartile Range|Median
2708025|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both.|||mm||Inter-Quartile Range|Median
2708026|NCT01187901|Primary|Change in Duodenal Polyp Burden From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months||||mm||Inter-Quartile Range|Median
2708027|NCT01187771|Secondary|Mean 24-hour Diastolic Blood Pressure||9 months||||mmHg||Standard Deviation|Mean
2708028|NCT01187771|Secondary|Direct Health Care Costs||9 months|Data not collected.||||||
2708029|NCT01187771|Secondary|Depression (Patient Health Questionnaire-9)|The PHQ-9 is scored from 0-27 with higher scores indicating more severe depression.|9 months||||PHQ-9 scale||Standard Deviation|Mean
2708030|NCT01187771|Secondary|Calgary Sleep Apnea Quality of Life Index|The Calgary Sleep Apnea Quality of Life Index results in scores ranging from 1-7, with higher scores indicating a higher quality of life.|9 months||||Units on Quality of Life Index||Standard Deviation|Mean
2708031|NCT01187771|Secondary|Insulin Resistance (HOMA Index)||9 months|Data were not collected.||||||
2708035|NCT01187550|Secondary|Change From Baseline in Lipid Profile at Week 4|Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||mmol/L||Standard Deviation|Mean
2708036|NCT01187550|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4|HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||pmol/L*mmol/L||Standard Deviation|Mean
2708037|NCT01187550|Secondary|Change From Baseline in Fasting Insulin at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||picomole/L (pmol/L)||Standard Deviation|Mean
2708038|NCT01187550|Secondary|Change From Baseline in Fasting Glucose at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||millimole/liter (mmol/L)||Standard Deviation|Mean
2708039|NCT01187550|Secondary|Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication.|||microgram/mL (mcg/mL)||Standard Deviation|Mean
2708040|NCT01187550|Primary|Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4|Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.|Baseline and Week 4|The intent-to-treat (ITT) population set included all the participants who received at least 1 dose of study medication.|||nanogram/millilter (ng/mL)||Standard Deviation|Mean
2708041|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708042|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708043|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708044|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708045|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708046|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708047|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708048|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708049|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708050|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708051|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708052|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708053|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708054|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708055|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708056|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708057|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708058|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708059|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708060|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708061|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708062|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708063|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708064|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708065|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708066|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708148|NCT01187355|Primary|Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.|||Units on a scale||Standard Deviation|Mean
2708067|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708068|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708069|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708070|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2708071|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
2708072|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
2708073|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
2708074|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
2708075|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
2708076|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708142|NCT01187381|Secondary|Percentage of Participants Who Had Surgical Procedure for Breast Cancer|Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).|Baseline up to 5 years|Number of participants analyzed=participants who were evaluable for this outcome measure|||percentage of participants|||Number
2708077|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708078|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708079|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708080|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708081|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708082|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708083|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708084|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708085|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708086|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708087|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708143|NCT01187381|Secondary|Percentage of Participants Who Received Previous Neoadjuvant Therapy|As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.|Baseline up to 5 years|Number of participants analyzed=participant with data available for this outcome|||percentage of participants|||Number
2708088|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708089|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708090|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708091|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2708092|NCT01187498|Secondary|Patient Desire for Alternate Treatment|"Patient response to Do you wish to receive another form of treatment? (yes)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
2708093|NCT01187498|Secondary|Patient Global Rating of Bothersomeness of Side Effects|"Patient global rating of how bothersome their side effects were (no side effects to extremely bothersome)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
2708094|NCT01187498|Secondary|Patient Report of Symptom Distress|"Patient report of how disturbed they were by symptoms (not at all to extremely)"|post-treatment (week 8)|Completers minos one missing value|||participants|||Number
2708095|NCT01187498|Secondary|Patient Global Rating of Activity Restriction|"Patient global rating of activity restriction (not at all to all the time)"|post-treatment (week 8)|Com0leters minus one missing value|||participants|||Number
2708096|NCT01187498|Secondary|Patient Satisfaction|"Patient global rating of satisfaction with progress in treatment (completely satisfied to very dissatisfied)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
2708097|NCT01187498|Secondary|Patient Global Perception of Improvement (GPI)|"Patient global perception of improvement (much better to much worse)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
2708098|NCT01187498|Secondary|Change on American Urological Association (AUA) Symptom Index|Change in score on American Urological Association (AUA) Symptom Index (baseline to week 8). The index measures lower urinary tract symptoms. Scores range from 0 to 35, with higher scores indicating worse symptoms.|baseline to post-treatment (week 8)|Completers|||Scores on the scale||Standard Deviation|Mean
2708099|NCT01187498|Secondary|Percent Change in Frequency of Urge Incontinence|Percent change in frequency of urge incontinence episodes based on 7-day bladder diary. Percent change was calculated as ([frequency at baseline] - [frequency at 8 weeks]) / (frequency at baseline).|baseline to post-treatment (week 8)|Included participants who experienced incontinence at baseline only|||Percent change in episodes per week||Standard Deviation|Mean
2708100|NCT01187498|Secondary|Change in Urgency Severity|"Indevus Urgency Severity Scale incorporated into the 7-day bladder diary. Scores for urgency severity ranged from 0 to 3:~0: None—no urgency~Mild—awareness of urgency, but is easily tolerated.~Moderate—enough urgency discomfort that it interferes with or shortens usual activity~Severe—extreme urgency discomfort that abruptly stops all activities or tasks."|baseline to post-treatment (week 8)|Participants who completed treatment and returned bladder diary with useable urgency scores|||Score on scale||Standard Deviation|Mean
2708101|NCT01187498|Secondary|Change in Nocturia Frequency|Change in frequency of nocturia episodes based on 7-day bladder diary|baseline to post-treatment (week 8)||||nocturia episodes per night||Standard Deviation|Mean
2708102|NCT01187498|Primary|24-hour Voiding Frequency|Mean voiding frequency per 24 hours derived from 7-day bladder dairy|post-treatment (week 8)|Treatment completers|||voids per 24-hour day||Standard Deviation|Mean
2708103|NCT01187446|Secondary|Duration of Clinical Benefit (Supplemental Follow-up)|Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment or until progressive disease, as measured by the mSWAT skin assessment.|140 weeks|The data are reported for the full period for which participant data are available.|||weeks||Full Range|Median
2708104|NCT01187446|Secondary|Duration of Clinical Benefit (Per Protocol Follow-up)|Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment until progressive disease, as measured by the mSWAT skin assessment, and censored at the final per-protocol assessment (48 weeks)|48 weeks after completion of treatment|The data are reported for the per-protocol period of follow-up (48 weeks).|||Weeks||Full Range|Median
2708144|NCT01187381|Secondary|Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation||Baseline up to 5 years|All enrolled participants|||percentage of participants|||Number
2708145|NCT01187381|Primary|Treatment Duration With Trastuzumab in the Routine Clinical Practice||Baseline up to 5 years|Number of participant analyzed=participants with data available for this outcome measure.|||Days||Standard Deviation|Mean
2708105|NCT01187446|Secondary|Clinical Response Rate (CRR)|"Clinical Response Rate (CRR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0, consisting of complete response (CR) rate; partial response (PR) rate; stable disease (SD) rate; or progressive disease (PD) rate.~CR = 100% clearance of skin disease (mSWAT score = 0) PR = 50%to <100% clearance of skin disease as measured by > 50% decrease of mSWAT score compared with baseline SD = Not CR, PR, or PD~PD = Whichever is met first of:~> 25% increase in skin disease from baseline as measured by > 25% increase of mSWAT score compared with baseline~New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or~In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of > [nadir + > 50% of baseline]~Relapse applies to any new disease after confirmed CR"|Week 8||||Participants|||Count of Participants
2708106|NCT01187446|Secondary|Safety and Tolerability as Measured by Severity and Frequency of Adverse Events|Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.|Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.||||Number of patients|||Number
2708107|NCT01187446|Primary|Complete Clinical Response (CCR)|Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response.|Week 8||||Participants|||Count of Participants
2708108|NCT01187433|Primary|Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo|Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2708109|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2708110|NCT01187433|Primary|Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2708111|NCT01187433|Primary|Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2708112|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2708113|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
2708114|NCT01187433|Primary|Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
2708115|NCT01187433|Primary|Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
2708146|NCT01187355|Secondary|Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.|||Units on a scale||Standard Deviation|Mean
2708116|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 Days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
2708117|NCT01187433|Primary|Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
2708118|NCT01187433|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
2708119|NCT01187407|Secondary|Pharmacokinetics: Plasma Concentrations of LY2216684|A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.|Pre-randomization, 1 week, 4 weeks, and 8 weeks|Participants exposed to LY2216684 with evaluable plasma concentration values. Samples with concentrations below the lower quantification limit (BQL) of the assay were treated as missing values for the analysis and samples with incomplete dosing information were not included in the pharmacokinetic assessment.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2708120|NCT01187407|Secondary|Change From Randomization to Week 8 in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2708121|NCT01187407|Secondary|Change From Randomization to Week 8 in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2708122|NCT01187407|Secondary|Change From Randomization to Week 8 in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708123|NCT01187407|Secondary|Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale|The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708124|NCT01187407|Secondary|Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Event module."|Randomization through 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2708147|NCT01187355|Secondary|Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.|||Units on a scale||Standard Deviation|Mean
2708125|NCT01187407|Secondary|Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708126|NCT01187407|Secondary|Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of maximum possible score||Standard Error|Least Squares Mean
2708127|NCT01187407|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708128|NCT01187407|Secondary|Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708129|NCT01187407|Secondary|Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)|CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708130|NCT01187407|Secondary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708131|NCT01187407|Secondary|Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708138|NCT01187407|Primary|Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708132|NCT01187407|Secondary|Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8|A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value. Last observation carried forward (LOCF) methodology was used.|||percentage of participants|||Number
2708133|NCT01187407|Secondary|Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708134|NCT01187407|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement|A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2708135|NCT01187407|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8|A MADRS total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value. Last observation carried forward (LOCF) methodology was used.|||percentage of participants|||Number
2708136|NCT01187407|Secondary|Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708137|NCT01187407|Secondary|Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708139|NCT01187381|Secondary|Percentage of Participants by the Site of First Disease Progression||Baseline up to 5 years|Number of participants analyzed=participants who presented disease progression|||percentage of participants|||Number
2708140|NCT01187381|Secondary|Progression Free Survival|Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.|Baseline uo tp 5 years|Number of participants analyzed=participants who presented progression of disease|||days||Full Range|Median
2708149|NCT01187329|Secondary|Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate|"Right ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values mean a worse outcome"|end of surgery (closure) an average of 5 minutes|some patient's echocardiography were low quality and can not be used|||Percent / sec||Standard Deviation|Mean
2708150|NCT01187329|Secondary|Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain|"Right ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values mean a worse outcome."|end of surgery (closure) an average of 5 minutes|some patient's echocardiography were low quality and can not be used|||percentage of myocardial shortening||Standard Deviation|Mean
2708151|NCT01187329|Primary|Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate|"Left ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values mean a worse outcome"|end of surgery (closure) an average of 5 minutes|some patient's echocardiography were low quality and can not be used|||Percent / sec||Standard Deviation|Mean
2708152|NCT01187329|Primary|Myocardial Function: Left Ventricular Global Longitudinal Strain (%)|"Left ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values (%) mean a worse outcome."|end of surgery (closure), an average of 5 minutes|some patient's echocardiography were low quality and can not be used|||percentage of myocardial shortening||Standard Deviation|Mean
2708153|NCT01187043|Primary|Induction Amenorrhea|Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.|10 weeks|Per protocol: subjects who exhibited trough levels of proellex on at least 7 of the 10 weekly visits during the dosing period|||participants|||Number
2708154|NCT01187017|Secondary|Secondary Endpoints Will Evaluated for the Study to Include: (a) Hematologic Response at 3 and 12 Months and Yearly Thereafter; (b) Relapse (c) Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH), Myelodysplasia or Acute Leukemia; (e) Survival.||12 months|||||||
2708155|NCT01187017|Primary|Response Rate at 6 Months|The primary objective is to assess the Flu/Cy hematological response in SAA.The primary endpoint will be response at six months.|6 months||||participants|||Number
2708156|NCT01187004|Secondary|Intensive Care Unit (ICU) Length of Stay|If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.|at 28 days|The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value|||days||Inter-Quartile Range|Median
2708157|NCT01187004|Primary|Acute Lung Injury After Cardiac Surgery|to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 <300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.|at seven days after intervention|Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of acute lung injury after cardiac surgery.|||participants|||Number
2708158|NCT01186939|Primary|Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period|Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.|43- 68 months|Safety population includes all 40 participants in the extension study.|||participants|||Number
2708159|NCT01186848|Primary|Live-rater by Two Blinded Dermatologists|"The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom 1550-nm Erbium-doped Fractionated Laser or Micro-focused Ultrasound and 1550nm-fractionated Laser resulted in the best cosmetic appearance."|week 10||||Percentage of participants||95% Confidence Interval|Number
2708160|NCT01186809|Secondary|Efficacy Measures|The proportion of patients achieving a complete, a partial or a hematologic improvement in responses to the experimental infusion of cytokine induced killer (CIK)cells|The clinical response will be registered at day +100 after the last Cytokine Induced Killer (CIK) cell infusion|||||||
2708161|NCT01186809|Primary|Safety Measures|The occurrence of a grade 4 acute graft versus host disease (GVHD), judged to be related to the study medication. Grading and staging will be performed using the Glucksberg scale|Clinical response was measured at 100 days after the completion of the cell therapy program.||||participants|||Number
2708162|NCT01186796|Secondary|Mean GH Half-Life in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||min||Standard Error|Mean
2708163|NCT01186796|Secondary|Mean Duration of GH Bursts (Mode) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||min||Standard Error|Mean
2708164|NCT01186796|Secondary|Mean Mass of GH Released Per Burst in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||ug/L||Standard Error|Mean
2708165|NCT01186796|Secondary|Mean GH Concentration (Pulsatile) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated by averaging values over the 6 hour collection timeframe.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||ug/L/6h||Standard Error|Mean
2708166|NCT01186796|Primary|Mean Baseline GH Concentration|Averaged over 90-min baseline on the saline day.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||ug/L||Standard Error|Mean
2708167|NCT01186770|Secondary|Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing|Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.|Baseline, Weeks 1 to 4|ITT population included all randomized participants who received at least 1 dose of study drug. Missing data was imputed using LOCF method.|||RFBMs||Standard Deviation|Mean
2708168|NCT01186770|Secondary|Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4|A responder was defined as at least 3 RFBMs/week, with an increase of at least 1 RFBM/week over baseline, for at least 3 out of the first 4 weeks of the treatment period. Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.|Weeks 1 to 4|ITT population included all randomized participants who received at least 1 dose of study drug. Missing data was imputed using last observation carried forward (LOCF) method.|||percentage of participants|||Number
2708169|NCT01186770|Primary|Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4|RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.|Weeks 1 to 4|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of days||Standard Deviation|Mean
2708170|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)||Weeks 4, 8, and 16 (Period C)|Safety-C|||percentage of participants|||Number
2708171|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)||Weeks 4, 8, 12, and 16 (Period B)|Safety-B|||percentage of participants|||Number
2708172|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)||Weeks 4, 8, 16, and 24 (Period A)|Safety-A|||percentage of participants|||Number
2708173|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
2708174|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation|||scores on a scale||Standard Error|Mean
2708175|NCT01186744|Secondary|Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708176|NCT01186744|Secondary|Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation.|||score on a scale||Standard Error|Mean
2708187|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-C defined as the last observation up to first dosing date in Period C.|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
2708177|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
2708178|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation|||scores on a scale||Standard Error|Mean
2708179|NCT01186744|Secondary|Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708180|NCT01186744|Secondary|Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n=number of participants with an observation.|||score on a scale||Standard Error|Mean
2708181|NCT01186744|Secondary|Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
2708182|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
2708183|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708184|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants|||Number
2708185|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percentage of participants|||Number
2708186|NCT01186744|Secondary|Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe|Baseline and Weeks 4, 8, 16 and 24 (Period A)|FAS-A|||percentage of participants|||Number
2726544|NCT01048502|Primary|The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).||randomization and 8 weeks post||||pg/mL||Inter-Quartile Range|Median
2708188|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-A defined as the last observation up to first dosing date in Period A.|Week 24 (Period A)|FAS-A; n=number of participants with an observation|||scores on a scale||Standard Error|Mean
2708189|NCT01186744|Secondary|Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708190|NCT01186744|Secondary|Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation|||score on a scale||Standard Error|Mean
2708191|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
2708192|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
2708193|NCT01186744|Secondary|Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708194|NCT01186744|Secondary|Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation|||score on a scale||Standard Error|Mean
2708195|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.|||weeks||95% Confidence Interval|Median
2708196|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708197|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||weeks||95% Confidence Interval|Median
2708198|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708199|NCT01186744|Secondary|Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants|||Number
2708200|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C DLQI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708201|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI >1 where Baseline-B defined as last observation up to first dosing date in Period B.|||percentage of participants|||Number
2708202|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≤1, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708203|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5|||percentage of participants||95% Confidence Interval|Number
2708204|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI ≥5.|||percentage of participants|||Number
2708205|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≥5, where Baseline-A is defined as the last observation up to first dosing date in Period A. n=participants with an observation.|||percentage of participants||95% Confidence Interval|Number
2708206|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||scores on a scale||Standard Error|Mean
2708207|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||scores on a scale||Standard Error|Mean
2708208|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
2708209|NCT01186744|Secondary|Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708210|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
2708211|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
2708222|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.|||weeks||95% Confidence Interval|Median
2708212|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||scores on a scale||Standard Error|Mean
2708213|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||scores on a scale||Standard Error|Mean
2708214|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
2708215|NCT01186744|Secondary|Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
2708216|NCT01186744|Secondary|Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708217|NCT01186744|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
2708218|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.|||weeks||95% Confidence Interval|Median
2708219|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI ≥2, where Baseline-C defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708220|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||weeks||95% Confidence Interval|Median
2708221|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708261|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||percent change in psoriatic BSA||Standard Error|Mean
2708223|NCT01186744|Secondary|ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708224|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||weeks||95% Confidence Interval|Median
2708225|NCT01186744|Secondary|ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708226|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI ≥2, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708227|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI ≥2, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708228|NCT01186744|Secondary|Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708229|NCT01186744|Secondary|Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI >1, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708230|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI greater than (>) 0, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
2708231|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI greater than (>) 0, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
2708232|NCT01186744|Secondary|Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. Baseline-C defined as the last observation up to first dosing date in Period C."|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2708233|NCT01186744|Secondary|Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. Baseline-B defined as the last observation up to first dosing date in Period B."|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
2708234|NCT01186744|Secondary|Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. Baseline-A defined as the last observation up to first dosing date in Period A."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
2708235|NCT01186744|Secondary|Mean ISI Score During the CP-690,550 Re-Treatment (Period C)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708236|NCT01186744|Secondary|Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
2708237|NCT01186744|Secondary|Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
2708238|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
2708239|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percentage of participants|||Number
2708240|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)|PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708241|NCT01186744|Secondary|Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
2708242|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
2708243|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
2708244|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708245|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708246|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; NRI|||percentage of participants||95% Confidence Interval|Number
2708247|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2708248|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2708249|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2708250|NCT01186744|Secondary|Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2708251|NCT01186744|Secondary|Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2726934|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|6 months||||percentage of donor cells||Standard Deviation|Mean
2708252|NCT01186744|Secondary|Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
2708253|NCT01186744|Secondary|Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||scores on a scale||Standard Error|Mean
2708254|NCT01186744|Secondary|Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||scores on a scale||Standard Error|Mean
2708255|NCT01186744|Secondary|Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
2708256|NCT01186744|Secondary|Mean PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
2708257|NCT01186744|Secondary|Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
2708258|NCT01186744|Secondary|Mean PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
2708259|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Baseline defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
2708260|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent psoriatic BSA||Standard Error|Mean
2708262|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
2708263|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent psoriatic BSA||Standard Error|Mean
2708264|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
2708265|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Baseline was defined as the last observation until first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||percent change in psoriatic BSA||Standard Error|Mean
2708266|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent change in psoriatic BSA||Standard Error|Mean
2708267|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||percent change in psoriatic BSA||Standard Error|Mean
2708268|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
2708269|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent psoriatic BSA||Standard Error|Mean
2708270|NCT01186744|Secondary|Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals the number of participants with an observation.|||percent psoriatic BSA||Standard Error|Mean
2708271|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
2708272|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants|||Number
2708273|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708274|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
2708275|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants|||Number
2708276|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708277|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C||Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||weeks||95% Confidence Interval|Median
2708278|NCT01186744|Secondary|Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||weeks||95% Confidence Interval|Median
2708279|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
2708280|NCT01186744|Secondary|Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C|||weeks||95% Confidence Interval|Median
2708281|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
2708282|NCT01186744|Secondary|Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)||Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||weeks||95% Confidence Interval|Median
2708283|NCT01186744|Secondary|Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)|Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.|Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
2708284|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 16 of Period B.|||percentage of participants|||Number
2708285|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4 and 8 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 8 of Period B.|||percentage of participants||95% Confidence Interval|Number
2708286|NCT01186744|Secondary|Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||weeks||95% Confidence Interval|Median
2708287|NCT01186744|Secondary|Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
2708381|NCT01185600|Primary|Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD235a+ red cell microparticles between at 1 hour post-surgery and at pre-surgery, i.e. levels at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery||||counts / uL||Standard Deviation|Mean
2708288|NCT01186744|Secondary|Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)|PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
2708289|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||weeks||95% Confidence Interval|Median
2708290|NCT01186744|Secondary|Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.|Weeks 4, 8, 16, and 24 (Period A)|The Period A-Full Analysis Set (FAS-A) included all participants who were randomized at baseline and received at least 1 dose of the randomized investigational drug (CP-690,550 5mg BID or 10 mg BID) during Period A.|||weeks||95% Confidence Interval|Median
2708291|NCT01186744|Primary|Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 4, 8, and 16 (Period C)|The Period C-Full Analysis Set (FAS-C) included all FAS-B participants who were advanced to the re-treatment period (Period C) during the 16 weeks of Period B and had received at least one dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period C.|||percentage of participants||95% Confidence Interval|Number
2708292|NCT01186744|Primary|Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
2708293|NCT01186744|Primary|Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
2708294|NCT01186744|Primary|Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.|Weeks 4, 8 12, and 16 (Period B)|The Period B-Full Analysis Set (FAS-B) included all participants who were re-randomized at the end of Period A and received at least 1dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) or placebo at the beginning of Period B.|||percentage of participants||95% Confidence Interval|Number
2708295|NCT01186705|Primary|Overall Objective Response Rate (ORR)|in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)|1 year||||participants|||Number
2708296|NCT01186692|Secondary|Changes in NYHA Functional Classification|Change in NYHA functional class from pre-implant to 6 month post-implant|6 Months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable paired NYHA data were included in the analysis.|||participants|||Number
2708297|NCT01186692|Secondary|Serious Device-related Adverse Events|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|6 months|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.|||percentage of patients|||Number
2708298|NCT01186692|Secondary|Serious Procedural Adverse Events|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|6 Months|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of patients|||Number
2708299|NCT01186692|Secondary|Procedural Success|"Procedural success is defined as a composite of the following:~The TPV is fixated within the desired location, and~The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and~There is no more than trivial pulmonary regurgitation by angiography~The subject is free from explantation of the TPV at 24 hours post-implant"|6 Months|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).|||percentage of patients|||Number
2708300|NCT01186692|Primary|Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation|"Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:~Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and~Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.~The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation."|6 months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis.|||percentage of patients||95% Confidence Interval|Number
2708301|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)|18 months|This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.|||min*ng/dL||Standard Error|Mean
2708302|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)|12 months|This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.|||min*ng/dL||Standard Error|Mean
2708303|NCT01186562|Secondary|AUC C-peptide|AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)|18 months|Patients with vomiting, NPO (Nothing by Mouth) restrictions (due to chronic GI illness) were not able to complete MMTT. (Mixed meal Tolerance Test) The N for each group reflects the number of patients who successfully completed this assessment.|||min*ng/dL||Standard Deviation|Mean
2708304|NCT01186562|Secondary|Area Under the Curve (AUC) C-peptide (ng/dL*Min)|AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)|12 months|Patients with vomiting, NPO restrictions (due to chronic GI illness) were not able to complete MMTT. The N for each group reflects the number of patients who successfully completed this assessment.|||ng*min/dL||Standard Error|Mean
2708305|NCT01186562|Secondary|Insulin Independence|percentage of patients insulin independent|18 months||||percentage of participants|||Number
2708306|NCT01186562|Primary|Insulin Independence|percentage of patients insulin independent|12 months|N's reflect patients that returned for study follow up.|||percentage of participants|||Number
2708307|NCT01186458|Secondary|Biologic Interaction|To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.||||||
2708308|NCT01186458|Secondary|Toxicity|To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.|6 months||||number of adverse events|||Number
2708309|NCT01186458|Secondary|Survival|To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.||||||
2708310|NCT01186458|Primary|Overall Response Rate|To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.|6 months|Data for this primary objective was not collected or analyzed due to the termination of the study.||||||
2708311|NCT01186419|Secondary|Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|92 weeks|PK Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.|||ng*hr/ml||Standard Deviation|Mean
2708312|NCT01186419|Secondary|Maximum Plasma Concentration (Cmax) of SPD602|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|92 weeks|Pharmacokinetic (PK) Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.|||ng/ml||Standard Deviation|Mean
2708313|NCT01186419|Primary|Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks|LIC was determined by R2 Magnetic Resonance Imaging (MRI).|Baseline and 96 weeks|Full Analysis Set, defined as all subjects in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all subjects who received any amount of investigational product.|||mg/g||Standard Deviation|Mean
2708314|NCT01186406|Secondary|Unacceptable Toxicity Related to the Treatment Regimen|The number of patients experiencing unacceptable toxicity defined as the occurrence of ≥ grade 2 CNS hemorrhage or treatment-related grade 4 or 5 non-hematologic toxicity.|27 months||||Participants|||Count of Participants
2708859|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708315|NCT01186406|Secondary|Median Progression-free Survival|Progression-free survival was defined as the time in months from the date study treatment started until the date of progression or the date of death if death occurred before progression, or until the date of last follow-up if alive without progression. Kaplan-Meier methods were used to estimate progression-free survival.|21 months|Intent-to-treat|||months||95% Confidence Interval|Median
2708316|NCT01186406|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat|||months||95% Confidence Interval|Median
2708317|NCT01186406|Primary|21-month Overall Survival|The percentage of participants alive at 21 months after the start of study treatment. Overall survival was calculated from the date study treatment started until the date of death or the date of last follow-up if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2708318|NCT01186328|Secondary|Disease Response|"Possible outcomes are:~Complete Remission (CR) defined as M1 bone marrow with no evidence of circulating blasts and with recovery of peripheral counts (ANC > 750 ul and PLT count > 75,000 uL) Complete Remission without Platelet Recovery (CRp) defined as attainment o M1 bone marrow with ANC > 750 uL, but with insufficient recovery of platelets (< 75,000 uL) Partial Remission (PR) defined as complete disappearance of circulating blasts and achievement of M2 marrow, without new sites of extramedullary disease and ANC > 750/uL) Stable Disease (SD) defined as recovery of ANC >750/uL but fails to qualify for CR, CRp, or PR Progressive Disease (PD) defined as an increase of at least 25% in absolute number of circulating leukemic cells, development of new sites of extramedullary disease, or other evidence of PD Induction Death defined as any patient who dies prior to receiving subsequent therapy"|Day 36||||Participants|||Count of Participants
2708319|NCT01186328|Primary|Maximum Tolerated Dose of EZN-3042|To determine the recommended dose of EZN-3042 administered weekly in combination with re-induction chemotherapy. Based on disease response at Day 36 and toxicity profile assessed until 30 days after discontinuation of study drug.|2 months|6 patients were enrolled at Dose Level 1. Dose level deescalated to Dose level 0 after 2 patients in Dose Level 1 experienced dose limiting toxicities. No patients were accrued on Dose level 0 prior to study closure.|||Participants|||Count of Participants
2708320|NCT01186250|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year|measure of low levels of C-reactive protein to identify low but persistent levels of inflammation|Baseline and 1 year|participant drop put|||mg/L||Standard Deviation|Mean
2708321|NCT01186250|Secondary|Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.|Competitive ELISA assay in Stanford laboratory.|Baseline and 1 year|One participant in one arm did not have Baseline or one year data.|||umol/L||Standard Deviation|Mean
2708322|NCT01186250|Secondary|Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)|The change in maximal intimal thickness (MIT) from baseline to one year was recorded for several matched sites in the same coronary artery, the cross sections, predominantly in the left anterior descending coronary artery, from baseline to one-year follow-up, were studied. The IVUS cross sections were matched by using identifiable landmarks in the images, such as bifurcations or arterial calcification, or external landmarks, such as coronary veins or pericardium. In addition, the one-year IVUS studies were obtained with an angiographic roadmap of where the initial IVUS study was performed along the length of the vessel. The IVUS system auto pullback was performed at .5 mm/s from the mid-distal portion of the study vessel, where an easily identifiable landmark was visible (i.e., branchpoint). The following items were measured for each patient: maximal intimal thickness (MIT), intimal area (IA), and vessel area.|Baseline and 1 year|number participants analyzed contained drops out due to clinical reasons|||mm||Standard Deviation|Mean
2708323|NCT01186250|Secondary|Change From Baseline in TG/HDL Ratio at One Year|Triglyceride ratio to High Density Lipoprotien|Baseline and 1 year|One drop out|||ratio||Standard Deviation|Mean
2708324|NCT01186250|Secondary|Change in Levels of Fasting Glucose at Baseline and 1 Year|Oral Glucose Tolerance Test : blood was drawn for fasting plasma glucose and insulin levels, followed by ingestion of a solution containing 75grams of glucose. Repeat blood samples were collected for glucose and insulin levels at 30, 90, and 120 minutes after glucose ingestion. All glucose measurements were performed by the Clinical Translational Research Unit (CTRU) Stanford University.|Baseline and 1 year|One participant in each group did not complete the OGTT.|||mg/dL||Standard Deviation|Mean
2708325|NCT01186250|Secondary|Change in Intimal Volume|Intimal volume is defined as external elastic membrane volume minus lumen (luminal) volume measured at the heart Catheterization and intravascular Ultrasound( IVUS)|baseline and 1 year|The number of participants enrolled were not all included in the intimal volume analysis because the Angiographic diagnostic evaluation needed for intimal volume measurement was clinically inappropriate for 3 in the pioglitazone arm and 5 in the Placebo arm at 12 months post transplant.|||mm^3||Standard Deviation|Mean
2708326|NCT01186250|Primary|Insulin Levels Area Under Curve(AUC)|Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.|Baseline and 1 year||||h*pmol/L||95% Confidence Interval|Mean
2708327|NCT01185964|Secondary|Percentage of Participants With Anti-Olaratumab Antibody Assessment|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline, Up to 30 Months|All participants who had baseline and post baseline anti-olaratumab antibodies.|||percentage of participants|||Number
2708328|NCT01185964|Secondary|PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab||Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||Days||Full Range|Geometric Mean
2708329|NCT01185964|Secondary|PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab|AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration.|Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||microgram•hour/milliliter (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2708330|NCT01185964|Secondary|PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab||Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2708331|NCT01185964|Secondary|Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab||Cycle 1 Day 1: Preinfusion, End of Infusion,1hr,48hr,72hr,168 hr Post infusion; Cycle 3 Day 1:Preinfusion, End of Infusion,1hr,24hr,48hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||nanogram/milliliter (μg/mL )||Geometric Coefficient of Variation|Geometric Mean
2708332|NCT01185964|Secondary|Percentage of Participants Who Are Progression-Free (PFS) at 3 Months|(PFS) rate is defined as the percentage of participants that are alive and progression-free 3 months after randomization. PFS is measured from randomization until the first radiographic progressive disease as defined by RECIST (version 1.1) or death from any cause. Participants who died without PD were considered to have progressed on the day of death. Censoring applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization or the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit. If participant started new treatment before PD, participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.|Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.|||percentage of participants||95% Confidence Interval|Number
2708333|NCT01185964|Secondary|Percentage of Participants With Objective Response (Objective Response Rate)|Objective Response Rate (ORR) is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Randomization Until Progressive Disease (Up to 30 Months)|All randomized participants in Phase 2 and optional Olaratumab monotherapy.|||percentage of participants||95% Confidence Interval|Number
2708334|NCT01185964|Secondary|Overall Survival (OS)|OS was defined as the date of randomization to the date of death from any cause. Reasons for censoring OS were that participant was known to be alive, participant was lost to follow up during the study or participant withdrew consent to follow up.|Randomization to the Date of Death From Any Cause (Up To 47 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored participants = Phase 2 Olaratumab + Doxorubicin = 27 and Doxorubicin = 15.|||Months||95% Confidence Interval|Median
2708335|NCT01185964|Secondary|Number of Participants With AEs and SAEs for Phase 2 Portion|A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline, Up to 30 Months|All randomized participants who received at least 1 dose of study drug in Phase 2 and optional Olaratumab monotherapy.|||participants|||Number
2708336|NCT01185964|Primary|Number of Participants With Treatment Related Adverse Events (TEAE), Adverse Events (AE) or Serious Adverse Events (SAE) for Safety for the Phase 1b Portion of the Study|All Phase 1b participants who experienced at least 1 TEAE in the Phase 1b portion of the study. Adverse Event with missing relationship to study is counted as related. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline Up to 30 Months|All participants in Phase 1b.|||participants|||Number
2708337|NCT01185964|Primary|Progression-free Survival (PFS)|PFS is measured from randomization until the first radiographic documentation of progression of disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause. Participants who died without PD was considered to have progressed on the day of death. The following censoring rules applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization. Participants were censored at the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last adequate radiographic visit. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.|Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.|||Month||95% Confidence Interval|Median
2708338|NCT01185834|Secondary|Overall Lens Fit|As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale|Participants|Standard Deviation|Mean
2708339|NCT01185834|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
2708340|NCT01185821|Secondary|Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set)|Six-month disability progression was defined relative to extension baseline EDSS score: 1.5 point increase in patients with baseline EDSS score of 0, 1.0 increase in patients with baseline EDSS score of between 0.5 to 5.0, inclusive and 0.5 increase in patients with baseline EDSS score of ≥ 5.5. The criteria for 6-month disability progression included detection of onset of progression and confirmation of progression for a period of at least 6 months.|Baseline Extension up to approximately 5 years||||percentage of participants||95% Confidence Interval|Number
2708341|NCT01185821|Secondary|Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set)|"Free of MRI disease activity is defined as free of Gadolinium enhanced T1 lesions at any scan; free of new or enlarging T2 lesions at any scan: free of both gadolinium enhanced T1 lesions and new or enlarging T2 lesions at any scan. Number of patients analyzed = patients with at least one MRI scan during the specified time period. New lesions at a specific visit are assessed relative to the previous scheduled visit scan.~No imputation of missing scans is performed. As a result missing scans can lead to an overestimation of the proportion of patients free of a specific MRI activity."|Baseline Extension up to approximately 5 years||||percentage of participants|||Number
2708342|NCT01185821|Secondary|Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set)|"Group level ARR (raw) is calculated as the total number of relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.~Model estimates are based on a negative binomial regression model, adjusted for treatment group, age, baseline EDSS, baseline number of Gd-enhanced T1 lesions and number of relapses in previous 2 years as covariates, with log(time on study in years) as the offset variable, using the log link."|Baseline extension up to approximately 5 years||||Group level ARR||95% Confidence Interval|Mean
2708343|NCT01185821|Primary|Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)||Baseline Extension up to approximately 5 years||||participants|||Number
2708344|NCT01185821|Primary|Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set)|"Most infections were clinical diagnoses and were not confirmed by microbiology / virologic investigations. A patient with multiple occurrences of an infection for a preferred term is counted only once in each specific category.~Events identified as infections by the Investigator and defined as an AE with onset on or after the first dose of Extension Study drug up to and including 30 days after the date of the last dose"|Baseline Extension up to approximately 5 years||||participants|||Number
2708345|NCT01185821|Primary|Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set)|Sitting blood pressure was measured in triplicate. The categories of notably low and high values and changes are presented for systolic (SBP) and diastolic (DBP). Multiple occurrences for a patient are counted as one occurrence in this table.|Baseline Extension up to approximately 5 years||||participants|||Number
2708346|NCT01185821|Primary|Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)|Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for >7 days. Abbreviations: washout = WO, Con=conduction|Baseline Extension up to day 10||||participants|||Number
2708347|NCT01185821|Primary|Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)|Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for >7 days. Abbreviation: Con=conduction, IVCD=intraventricular conduction defect , WPW=Wolff-Parkinson-White syndrome|Baseline Extension up to day 10||||participants|||Number
2708348|NCT01185821|Primary|Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study.|Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.|Baseline up to approximately 5 years||||events|||Number
2708349|NCT01185782|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment period to post-treatment assessment period (Day 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.|||participants|||Number
2708350|NCT01185782|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.|Pretrial observation period to post-treatment assessment period (Days 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.|||participants|||Number
2708351|NCT01185782|Secondary|Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy|For this secondary endpoint, participants were considered to have ovulated if serum P4 level was more than or equal to 10 ng/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 during post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent ovulation|||Number
2709005|NCT01181011|Secondary|Terminal Rate Constant in Plasma (λz) of Telmisartan|reflect the speed of drug elimination in vivo|3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Telmisartan|||1/h||Standard Deviation|Mean
2708352|NCT01185782|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Day 35-42 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent clinical pregnancy|||Number
2708353|NCT01185782|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period|Day 28-31 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent biochemical pregnancy|||Number
2708354|NCT01185782|Secondary|Single Follicle Maturation Rate|Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent single follicle maturation|||Number
2708355|NCT01185782|Secondary|Human Chorionic Gonadotropin (hCG) Cancellation Rate|hCG cancellation criterion was defined as the presence of 4 or more ovarian follicles with a mean diameter greater than or equal to 16 mm. If the hCG cancellation criterion was met, the administration of hCG was withheld. Otherwise, a single intramuscular dose of hCG 5000 IU (Japanese Pharmacopoeia- JP) was administered within 24 hours of the last ultrasound examination.|Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent hCG cancellation|||Number
2708356|NCT01185782|Secondary|Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter|Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.|||IU||Standard Deviation|Mean
2708357|NCT01185782|Secondary|Time for Dominant Follicle to Achieve 18 mm in Mean Diameter|Dosing time length was calculated as number of days from the first administration of the IMP until the mean diameter of the dominant follicle was confirmed to have reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis.|||days||Standard Deviation|Mean
2708358|NCT01185782|Secondary|Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter||Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||participants|||Number
2708359|NCT01185782|Primary|Percentage of Participants With Ovulation|Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]|Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.|||percentage of participants|||Number
2708360|NCT01185704|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.|Day 1 up to end of study (15 days post last administration of study drug)||||participants|||Number
2708361|NCT01185704|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||percentage of participants|||Number
2708362|NCT01185704|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent sacs per embryo|||Number
2708363|NCT01185704|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus.|Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||transferred embryos||Standard Deviation|Mean
2708364|NCT01185704|Secondary|Number of Blastocysts|Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.|Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||blastocysts||Standard Deviation|Mean
2708365|NCT01185704|Secondary|Number of Embryos|Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.|Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||embryos||Standard Deviation|Mean
2708366|NCT01185704|Secondary|Percentage of Fertilized Oocytes Retrieved|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent fertilized oocytes||Standard Deviation|Mean
2708367|NCT01185704|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||international unit (IU)||Standard Deviation|Mean
2708368|NCT01185704|Secondary|Number and Quality of Oocytes Retrieved|Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||oocytes||Standard Deviation|Mean
2708369|NCT01185704|Secondary|Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||follicles||Standard Deviation|Mean
2708370|NCT01185704|Secondary|Anti Mullerian Hormone (AMH) Levels||Day 0|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2708371|NCT01185704|Secondary|Serum Progesterone (P4) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanomolar/liter (nmol/L)||Standard Deviation|Mean
2708372|NCT01185704|Secondary|Serum Estradiol (E2) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2708373|NCT01185704|Secondary|Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels||Day 1|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Here n signifies those participants who were evaluated for specified category."|||International unit/liter (IU/L)||Standard Deviation|Mean
2708374|NCT01185704|Primary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|"Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2708375|NCT01185639|Secondary|Impact of Treatment on Quality of Life (FACT-L)|Using the Functional Assessment of Cancer Therapy - Lung (FACT-L) a 36-item self-administered questionnaire evaluating physical, social/family, emotional, and functional well-being; subscales (symptoms, cognitive function, regret of smoking) on a five-point scale from 0 (not at all) to 4 (very much). Maximum score 136. Subscale scores added to obtain total score. The higher the score the greater the impact on the quality of life.|up to 3 months after treatment||||score on a scale||Standard Deviation|Mean
2708376|NCT01185639|Secondary|Overall Survival|Overall survival will be reported with an exact 95% confidence interval.|up to 4 years||||months||95% Confidence Interval|Median
2708377|NCT01185639|Secondary|Number of Participants With Local Control|Local control (LC) of SBRT-treated lesions will only be assessed in patients with at least 4-months of radiographic follow-up.|up to 2 years||||Participants|||Count of Participants
2708378|NCT01185639|Secondary|To Assess Physical Function for This Cohort of Patients|Using the Vulnerable Elders Survey (VES-13) A 13-item self-reporting questionnaire includes age, self-rated health, limitations in physical function and disability to assess for deterioration of physical function/health. Scoring for the VES-13 is as follows: Total scores are summed together based on self-rated health (0-1), physical function (0-2), functional disability (0-4), (range from 0 to 7). A total score of 3 or more identifies participants as vulnerable to the risk of decline of physical function.|up to 3 months after treatment||||Score on a scale||Standard Deviation|Mean
2708379|NCT01185639|Primary|Progression-free Survival|Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or <25%or original size; partial >30% decrease of target lesion; stable <30% decreased of target lesion and; local failure increase >20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.|up to 2 years||||months||95% Confidence Interval|Median
2708380|NCT01185600|Secondary|Each Participant's Number of Non-serious Adverse Events|All clinical non-serious adverse events reported in the clinical chart were recorded in the study's data files. This type of events, defined as Non-Serious Adverse Events or just Adverse Events (AEs) were categorized into 5 groups: (1) Cardiovascular / respiratory; (2) renal; (3) neurologic (CNS); (4) infections; and (5) other. For each participant, the outcome measure was defined as the number of AE's he or she experienced during his/her hospital stay.|Within 30 days after CABG surgery||||Adverse events||Standard Deviation|Mean
2708382|NCT01185600|Primary|Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD62E+ endothelial microparticles between 1 hour post-surgery and at pre-surgery, i.e. level at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."|||counts / uL||Standard Deviation|Mean
2708383|NCT01185600|Primary|Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery|Difference in levels of circulating Annexin V+ microparticles between at pre-surgery and 1 hour post-surgery, i.e. level of Annexin V+ microparticles at 1 hour post-surgery - level of Annexin V+ microparticles at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."|||counts / uL||Standard Deviation|Mean
2708384|NCT01185600|Primary|Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD41+ platelet microparticles between at pre-surgery and at 1hour post-surgery, i.e. level at 1hour post-surgery - level at pre-surgery|interval between presurgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."|||counts / uL||Standard Deviation|Mean
2708385|NCT01185600|Primary|Occurrence of at Least One Serious Adverse Event (SAE)|Comparison of the two groups with respect to occurrence or not of at least one SAE including sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest.|within 30 days after CABG surgery||||participants|||Number
2708386|NCT01185600|Primary|One-year Mortality|Number participants who expired within one year after CABG surgery|Within one year after CABG surgery|During the 12 months after hospital discharge, one participant in the group of transfusion with washed RBC and 3 participants in the group of transfusion with unwashed RBC were lost to follow up.|||participants|||Number
2708387|NCT01185600|Primary|In Hospital Mortality|The number of participants who expired during hospital stay after CABG surgery|Within 30 days after CABG surgery||||participants|||Number
2708388|NCT01185561|Secondary|State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score|Scores on the The State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
2708389|NCT01185561|Secondary|State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score|Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
2708390|NCT01185561|Secondary|State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score|Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
2708391|NCT01185561|Primary|Center for Epidemiologic Studies Depression (CES-D) Score|The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
2708392|NCT01185548|Secondary|Pharmacokinetics of Tolbutamide, Observed Time at Maximal Concentration (Tmax)||Period 1, 2, and 3 Predose; and 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 6, 8, 24, 48, 72, 96, 120, 168, 264, 336 hours post tolbutamide dose|All enrolled participants who started Periods 1, 2, or 3.|||hours||Full Range|Median
2708393|NCT01185548|Secondary|Pharmacokinetics of Tolbutamide, Maximum Concentration (Cmax)||Period 1, 2, and 3 Predose; and 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 6, 8, 24, 48, 72, 96, 120, 168, 264, 336 hours post tolbutamide dose|All enrolled participants who started Periods 1, 2, or 3.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2708394|NCT01185548|Secondary|Pharmacokinetics of Tolbutamide, Staggered Dosing in Period 3, Area Under the Curve (AUC 0-∞)|AUC0-∞ is defined as the area under the concentration time curve from time 0 to infinity.|Period 3 Predose; and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 24, 48, 96, and 264 hours post tolbutamide dose|All enrolled participants who started period 3 (tasisulam then tolbutamide).|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2708395|NCT01185548|Primary|Pharmacokinetics of Tolbutamide, Concurrent Dosing, Area Under the Curve (AUC 0-∞)|AUC0-∞ is defined as the area under the concentration time curve from time 0 to infinity.|Period 2 Predose; and 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 6, 8, 24, 48, 72, 120, 168, 336 hours post tolbutamide dose|All enrolled participants who started Period 2 (tasisulam and tolbutamide).|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2708522|NCT01184872|Secondary|Duration of Treatment (Intravenous and Oral)|Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis set (FAS) comprised all patients to whom study treatment had been assigned at randomization.|||Days||Standard Deviation|Mean
2708396|NCT01185522|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 4 months|Safety population consisted of all participants included in the study, who respected the inclusion and non-inclusion criteria and who at least one tocilizumab infusion.|||Number of Participants|||Number
2708397|NCT01185522|Secondary|Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4|Participants with tocilizumab treatment were managed according to number of tocilizumab treatment received according to Summary of Product Characteristics recommendations, as 8 mg/kg, dose duration of 1-hour, correct infusion progress; and received DMARD, methotrexate, and corticosteroids concomitantly with tocilizumab during Months 1 to 4.|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Number of Participants|||Number
2708398|NCT01185522|Secondary|Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4|Fatigue was assessed by FACIT-Fatigue scale (ranging from 0 [worse score] to 52 [better score]) and VAS fatigue (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]). Other participant reported outcomes (PROs) were VAS for pain and quality of sleep (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]), SF36 vitality score (ranging from 0 [worst] to 100 [best]) and HAD score (calculated using the 14 items and each item was scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales were summed; each resulting in a total score of 0-21). Correlation between fatigue as assessed by FACIT-Fatigue score or VAS fatigue was evaluated for all participants using a linear regression and were reported for D0 and M4.|Day 0 and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Coefficient of correlation|||Number
2708399|NCT01185522|Secondary|Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4|FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), VAS (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]) and SF36 vitality score (ranging from 0 [worst] to 100 [best]) were calculated at Baseline and Month 4.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Percentage of participants|||Number
2708400|NCT01185522|Secondary|Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4|A PASS score at Day 0 and Month 4 calculated on participants with acceptable symptom state. PASS is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Number of participants|||Number
2708401|NCT01185522|Secondary|Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and CRP value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. CRP values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in CRP level up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.|||Percent change||Full Range|Median
2708402|NCT01185522|Secondary|Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and ESR value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. ESR values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in ESR values up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.|||Percent change||Full Range|Median
2708403|NCT01185522|Secondary|Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4|"Relative change (RC) from Baseline (BL) in disease activity included TJC and SJC was evaluated as continuous variables for all participants at each evaluation time points.~For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in TJC and SJC up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.|||Percent change||Full Range|Median
2708404|NCT01185522|Secondary|Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4|Relative change from Baseline (BL) in DAS 28 was evaluated for all participants at each evaluation time (on raw data at inclusion; at Month 1, Month 2, Month 3, and Month 4 using a linear regression. DAS-28 and VAS patient's global assessment (PGA) were described as continuous variables for all participants at each evaluation time points (Baseline to M4). DAS 28 ranging from 0 (no disease activity) to 10 (worsening in disease activity) and VAS PGA ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening of symptoms and arthritis disease activity),|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in DAS 28 up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.|||Percent change||Full Range|Median
2708405|NCT01185522|Secondary|Median Time to Onset of an Improvement of the FACIT-Fatigue Score|The time of onset of a clinically significant improvement of fatigue was defined as the time between the date of the first tocilizumab infusion and the date of the first increase of at least 4 points of the FACIT-Fatigue score (date of questionnaire completion) during 4 months of tocilizumab treatment. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score).|Up to Month 4|Patient analysis population was considered. Participants with increase of at least 4 points of the FACIT-Fatigue score were analyzed for this outcome measure.|||Months||95% Confidence Interval|Median
2708406|NCT01185522|Secondary|Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment|Correlation between FACIT-Fatigue score and VAS fatigue was evaluated for all participants at inclusion and after 4 months of tocilizumab treatment (relative change from baseline) using a linear regression. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity)|From Baseline (D0) to Month (M) 4|Patient analysis population was considered. Participants with Changes in FACIT-Fatigue Score and VAS Fatigue at Month 4 were analyzed for this outcome measure.|||Correlation Coefficient|||Number
2708407|NCT01185522|Primary|Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment|"Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen.~For tender joint count (TJC), a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.~For swollen joint count (SJC), a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.|||Number of joints||Standard Deviation|Mean
2708408|NCT01185522|Primary|Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment|Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. C-reactive protein (CRP) is one of the biomarkers for the diagnosis and assessment of disease activity in RA.|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.|||milligram per liter||Inter-Quartile Range|Median
2708409|NCT01185522|Primary|Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors|Predictive factors of fatigue were taken into account included gender, age, time since initial diagnosis, Erosive RA, disease activity score (DAS, ranging from 0 [no disease activity] to 10 [worsening in disease activity]), erythrocyte sedimentation rate (ESR), anemia, treatment with corticosteroids, doses of corticosteroids, health assessment questionnaire (HAQ, ranging from 0 [without any difficulty] to 60 [worsening or unable to do physical activities]), FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), visual analogue score (VAS) for fatigue, pain, quality of sleep, and global assessment (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]), Short Form 36 (SF36) vitality score (ranging from 0 [worst] to 100 [best]), Hospital Anxiety and Depression Scale (HADS; represented as score </= 7 [no case], 7 to 10 [doubtful case], and > 10 [certain case of HAD]).|At Month 4|Patient analysis population was considered. Participants whom baseline characteristics were available at inclusion and who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.|||Number of participants|||Number
2708523|NCT01184872|Secondary|Duration of Treatment (Intravenous)|Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned at randomization.|||Days||Standard Deviation|Mean
2709006|NCT01181011|Secondary|Time to Attain Cmax (Tmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Telmisartan|||h||Standard Deviation|Mean
2708410|NCT01185522|Secondary|Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score|FACIT-fatigue score and VAS fatigue score were fatigue assessment parameters. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranges from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Clinically relevant improvement is defined as >/= 4-point change from Baseline.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular time fatigue scores.|||Scores on a scale||Standard Deviation|Mean
2708411|NCT01185522|Secondary|Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue|High Erythrocyte Sedimentation Rate (ESR) was defined as (1) for participants aged up to 50 years: > 15 mm/h for men and > 20 mm/h for women, and (2) for participants aged over 50 years: > 20 mm/h for men and > 25 mm/h for women. Anemia was defined as plasma hemoglobin level <12 gram per deciliter (g/dL) for women and <13 g/dL for men. The CRP test is evaluated for an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Patient-Acceptable Symptom State (PASS) that is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.|||Number of participants|||Number
2708412|NCT01185522|Secondary|Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters|DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/h), and patient's global assessment of disease activity (measured on a 100-mm visual analog scale, where 0 is no disease activity and 100 is maximum disease activity). The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening disease activity. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain. HAQ indicates how the disease affected participant's activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.|||Scores on a scale||Standard Deviation|Mean
2708413|NCT01185522|Secondary|Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count|"For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.~For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Tender joint count and swollen joint count were assessed at baseline and were used as baseline disease characteristics for assessment of rheumatoid arthritis."|Baseline (D0)|Patient analysis population was considered. n = number of participants available for particular parameters.|||Number of joints||Standard Deviation|Mean
2708414|NCT01185522|Secondary|Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies|Blood was collected for Rheumatoid Factor (RF) at Baseline and was analyzed. RF level was reported in international units/milliliter (IU/mL). All participants were assessed for anti-cyclic citrullinated protein (anti-CCP) antibodies at baseline. Number of participants with a positive RF and/or anti-CCP antibodies were reported as baseline disease characteristics.|Baseline (D0)|Patient analysis population was considered. Participants with positive RF and/or anti-CCP antibodies at baseline were analyzed for this outcome measure.|||Number of Participants|||Number
2708415|NCT01185522|Secondary|Baseline Disease Characteristics: Mean Disease Duration|Mean disease (rheumatoid arthritis) duration at inclusion was recorded for all participants as baseline disease characteristics.|Baseline (Day [D] 0)|Patient analysis population was considered. Participants for whom data of disease duration was available at baseline were analyzed for this outcome measure.|||years||Standard Deviation|Mean
2708426|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains (physical functioning, bodily pain, role limitations due to physical problems and also emotional problems, general health, mental health, social functioning and vitality) and 2 component scores (PCS and MCS). The PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. The MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.|Baseline, Week 12|All randomized participants who received study drug in Part A and had SF-36 evaluated at analysis time point. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708416|NCT01185522|Primary|Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment|"Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses resulted a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Clinically relevant improvement is defined as a >= 4-point change from Baseline.~This was performed using the last observation carried forward (LOCF) method and for participants who completed a FACIT-Fatigue score at Month 4 (completers)."|At Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment.|||Percentage of participants||95% Confidence Interval|Number
2708417|NCT01185509|Secondary|Baseline Level of Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed at baseline|The CTCs in cohort A were analyzed using a non-CLIA approved assay and thus it was felt that the outcome data for this cohort were not evaluable. A new CLIA approved assay was used for the main cohort.|||cells per 7.5 ml blood||Full Range|Median
2708418|NCT01185509|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks and within 2 wks off-study; Median follow-up was 2.7 months.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2708419|NCT01185509|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).|The analysis dataset is comprised of all treated patients.|||percentage of patients||95% Confidence Interval|Number
2708420|NCT01185509|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).|The analysis dataset is comprised of all treated patients.|||percentage of patients||95% Confidence Interval|Number
2708421|NCT01185353|Secondary|Mean Change From Baseline Through Week 12 in the ENSEMBLE Minimum Data Set 1.0||Baseline, 12 weeks|Zero participants were analyzed. Assessment of ENSEMBLE Minimum Data Set 1.0 was not collected at Week 12 and therefore results are not reported for outcome measure.||||||
2708422|NCT01185353|Secondary|Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104||Baseline through 24 weeks|All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.|||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2708423|NCT01185353|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Baseline through 24 weeks|All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.|||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2708424|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score|"The FACIT-F Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12|All randomized participants who received study drug in Part A and had FACIT-F evaluated at Week 12. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708425|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Brief Pain Inventory Modified Short Form (BPI-sf Modified) Worst-Pain-in-the Past-24-hours Item Score|"The BPI-sf modified is a self-administered questionnaire developed for the rapid assessment of pain. The BPI-sf modified provides information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The questionnaire asks questions about pain relief, pain quality, and the participant's perception of the cause of pain. The BPI-sf modified uses a numeric rating scale from 0 (No pain) to 10 (Pain as bad as you can imagine). Since pain can be quite variable over a day, the BPI-sf modified asked participants to rate their pain at the time of responding to the questionnaire (right now), and also at its worst, least and average over the last 24 hours."|Baseline, Week 12|All randomized participants who received study drug and had BPI-sf worst-pain-in-the past-24-hours item evaluated at Week 12. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708427|NCT01185353|Secondary|Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness|The Investigator asked participants about the duration of their morning stiffness (in minutes) in and around the joints and recorded the duration. The Investigator asked the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.|Baseline, Weeks 4, 8, 12|All randomized participants who received study drug in Part A and had morning stiffness evaluated at analysis time points. LOCF was used to impute missing post-baseline values for Week 12 analysis.|||minutes||Standard Deviation|Mean
2708428|NCT01185353|Secondary|Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores <2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points.|||percentage of participants|||Number
2708429|NCT01185353|Secondary|Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24|Disease Activity Score (DAS) modified to include 28-joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores <2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.|Baseline through Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had DAS28-CRP evaluated at analysis time points.|||percentage of participants|||Number
2708430|NCT01185353|Secondary|Percentage of Responders According to EULAR28 Baseline Through Weeks 76 and 128|EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score >5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by >0.6 units but ≤1.2 units or post-baseline DAS28 score >3.2 with improvement by >1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by >1.2 units).|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had EULAR28 evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||percentage of participants|||Number
2708431|NCT01185353|Secondary|Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24|EULAR28 categorizes clinical response based upon improvement since baseline in DAS modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: TJC28, SJC28, CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score >5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by >0.6 units but ≤1.2 units or post-baseline DAS28 score >3.2 with improvement by >1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by >1.2 units).|Baseline through Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had EULAR28 evaluated at analysis time points.|||percentage of participants|||Number
2708432|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708433|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had DAS28-CRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708434|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain|Physician's and Patient's assessments of DA assessed using a VAS that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had physician's and participant’s assessments of disease activity and pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708435|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain|Physician's and Patient's Assessments of Disease Activity (DA) assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeters (mm), where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis was also assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had physician's and participant’s assessments of disease activity and participant’s pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708436|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in ESR|ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had ESR evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||mm/hr||Standard Deviation|Mean
2708437|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had ESR evaluated at analysis time points.|||mm/hr||Standard Deviation|Mean
2708438|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in hsCRP|hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||mg/L||Standard Deviation|Mean
2708439|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)|hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||mg/L||Standard Deviation|Mean
2708440|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708441|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708442|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2708443|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values|||number of joints||Standard Deviation|Mean
2708444|NCT01185353|Secondary|ACR Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of a) % of improvement in TJC, b) % of improvement in SJC, and c) third highest percentage of improvement of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to a range of -100 to 100 to minimize impact of outliers (greater scores indicate greater % improvement) and negative scores indicate a decline. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR-N at Week 12 had these components imputed by LOCF.|||percentage of improvement||95% Confidence Interval|Number
2708445|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR50 index at analysis time point had these components imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2708446|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
2708447|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
2708448|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR50 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
2708449|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR50 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
2708450|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
2708451|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
2708585|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Secondary goals include evaluating effects of this medication on severity of obstructive sleep disordered breathing (SDB) (validated by Sleep Disorders Questionnaire (SA-SDQ)). Subjects were divided into 3 subgroups: improved (less negative SA-SDQ score), unchanged, or worsened (more negative SA-SDQ score).|16 weeks||||participants|||Number
2708452|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2708453|NCT01185353|Primary|Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Baseline through Week 12|All randomized participants who received placebo, 4 mg or 8 mg LY3009104 in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by last observation carried forward (LOCF).|||percentage of participants|||Number
2708454|NCT01185340|Secondary|Change From Randomization to Week 8 in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2708455|NCT01185340|Secondary|Change From Randomization to Week 8 in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2708456|NCT01185340|Secondary|Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708457|NCT01185340|Secondary|Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale|The Arizona Sexual Experiences (ASEX) scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708458|NCT01185340|Secondary|Percentage of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2708459|NCT01185340|Secondary|Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708460|NCT01185340|Secondary|Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a self-administered, 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of the maximum possible score||Standard Error|Least Squares Mean
2708461|NCT01185340|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items|The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708462|NCT01185340|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score|The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708463|NCT01185340|Secondary|Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)|Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708464|NCT01185340|Secondary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708465|NCT01185340|Secondary|Change From Randomization to Week 8 in The Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708466|NCT01185340|Secondary|Probability of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8|A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). A categorical repeated measures analysis modeled the probability of response at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.|8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||probability||Standard Error|Least Squares Mean
2708482|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26|"Response, as defined by ACR 50 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708467|NCT01185340|Secondary|Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708468|NCT01185340|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement|A Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2708469|NCT01185340|Secondary|Probability of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 at Week 8|A Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). A categorical repeated measures analysis modeled the probability of remission at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.|8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||probability||Standard Error|Least Squares Mean
2708470|NCT01185340|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score|The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708471|NCT01185340|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Score|The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708472|NCT01185340|Primary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2708473|NCT01185301|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26|CDAI is a measure of disease activity derived as follows: CDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]). CDAI total score = 0 to 76. CDAI ≤ 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, > 10 to 22 = moderate disease activity, and > 22 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708518|NCT01184885|Secondary|Complete Response|"To describe response rates to hyper-CVAD and sirolimus in adults with ALL and other aggressive lymphoid malignancies.~Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)."|Every 21 days or as count recovery allows (at least 14 days apart) up to 24 weeks||||participants|||Number
2708474|NCT01185301|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26|SDAI is a measure of disease activity derived as follows: SDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) + CRP (mg/dL), where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]), and CRP is C-reactive protein measured in mg/dL. SDAI total score = 0 to 86. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708475|NCT01185301|Secondary|Percentage of Participants With No Radiographic Progression at Week 26|"No radiographic progression was defined as a change from Baseline in modified Total Sharp Score (mTSS) at Week 26 of ≤ 0.5. mTSS is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708476|NCT01185301|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26|The modified Total Sharp Score (mTSS) is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population with available data at time point (observed cases).|||score on a scale||Standard Deviation|Mean
2708477|NCT01185301|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ -0.22 at Week 26|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from Baseline of ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708478|NCT01185301|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population with non-missing baseline and at least 1 non-missing post-baseline value (baseline is defined as the last non-missing value prior to the first dose of study drug); last observation carried forward.|||units on a scale||Standard Deviation|Mean
2708479|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26|"Response, as defined by ACR 100 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 100% improvement in tender joint count; ≥ 100% improvement in swollen joint count; and ≥ 100% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708480|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26|"Response, as defined by ACR 90 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708481|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26|"Response, as defined by ACR 70 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708483|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26|"Response, as defined by ACR 20 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708484|NCT01185301|Secondary|Percentage of Participants With DAS28(CRP) Remission at Week 26|Disease remission was defined as a disease activity score, based on CRP, for 28 joints that was < 2.6 (DAS28[CRP] < 2.6). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708485|NCT01185301|Primary|Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26|Percentage of participants achieving low disease activity as defined by a clinical response (DAS28[CRP] < 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
2708486|NCT01185288|Other Pre-specified|Serum Adalimumab Trough Concentrations at Week 24|Serum trough concentrations of adalimumab assessed at week 24 (24 weeks after the 1st dose).|Week 24|All participants with available pharmacokinetics at week 24: For Adalimumab + Low Dose Methotrexate, n = 134; for Adalimumab + High Dose Methotrexate, n = 140.|||µg/mL||Standard Deviation|Mean
2708487|NCT01185288|Secondary|Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24|The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
2708488|NCT01185288|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
2708489|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24|Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
2708490|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24|Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
2708519|NCT01184885|Secondary|Induction Mortality|Induction mortality. Hyper-CVAD/ Rapamycin will be considered acceptable if induction mortality does not exceed 31% in patients older than 60, or 15% in those younger than 60|18 months|||||||
2708586|NCT01184118|Primary|Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Upper airway (UAW) collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes. Subjects were divided into 3 subgroups: improved (more negative Pcrit), unchanged, or worsened (less negative Pcrit).|16 weeks||||participants|||Number
2708491|NCT01185288|Secondary|Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24|PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
2708492|NCT01185288|Primary|Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24|The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.|Week 24|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed using last observation carried forward (LOCF).|||scores on a scale||95% Confidence Interval|Least Squares Mean
2708493|NCT01185249|Primary|The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients||Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3.|Patients with three consecutive days of morning and evening weights.|||kilograms||Standard Deviation|Mean
2708494|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.~Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15."|Baseline to 1st day of visit 15||||ratio||95% Confidence Interval|Least Squares Mean
2708495|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.~Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15."|Baseline to 1st day of visit 15||||ratio||95% Confidence Interval|Geometric Mean
2708496|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)||||L/min||Standard Deviation|Mean
2708497|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)||||L/min||Standard Deviation|Mean
2708498|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)||||Scores on a scale||Standard Deviation|Mean
2708499|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)||||Scores on a scale||Standard Deviation|Mean
2708520|NCT01184885|Primary|Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival|"This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of > 0.5 x 10^9/L and platelet count > 50 x 10^9/L.~Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects."|18 months||||participants|||Number
2708500|NCT01185080|Primary|of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
2708501|NCT01185080|Primary|Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
2708502|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
2708503|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
2708504|NCT01185080|Primary|Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
2708505|NCT01185080|Primary|Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
2708506|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
2708521|NCT01184872|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||Continuously from baseline up to 28 days after end of antibiotic treatment.|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.|||participants|||Number
2708587|NCT01184079|Secondary|Safety Profile|Total proportion of side effects reported after any dose, compared by arm.|1 week after vaccination|Intention-to-treat|||percentage of doses with side effects|||Number
2708507|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
2708508|NCT01185028|Primary|Number of Participants With Adverse Events|Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.|2 years||||adverse events|||Number
2708509|NCT01185028|Secondary|Tolerability|Proportion of individuals that discontinued study drug|2 years|||||||
2708510|NCT01185028|Secondary|Sustained Viral Response Rate|Proportion of participants that are HCV negative 6 months after treatment completion|72 weeks||||participants|||Number
2708511|NCT01184989|Primary|Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS|Dabigatran Concentration in Plasma, measured with HPLC-MS/MS - Most relevant timepoints are reported here, ie timepoints of day 6|At day 6 before drug intake (di), at 1h, 2h, 4h, 8h and 24h after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2708512|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured centrally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting|||measurements estimated as above LLOQ|Measurements||Number
2708513|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured locally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting|||measurements estimated as above LLOQ|Measurements||Number
2708514|NCT01184898|Secondary|Partial Response|"Partial response is defined as:~Requires that all of the criteria for complete remission be satisfied except that the bone marrow may contain ≥ 5% blasts but < 25% blasts.~A marrow with <5% blasts that contain Auer rods will also be considered a PR"|Within one week of peripheral count recovery but no later than day 42||||participants|||Number
2708515|NCT01184898|Secondary|Complete Response in the Absence of Platelet Recovery|"Complete response in the absence of platelet recovery is defined as:~- Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)"|Within one week of peripheral count recovery but no later than day 42||||participants|||Number
2708516|NCT01184898|Secondary|Complete Response|"Complete response is defined as:~Peripheral Blood Counts -Neutrophil count >1 x 109/L.~Platelet count ≥ 100 x 109/L.~Reduced hemoglobin concentration or hematocrit has no bearing on remission status.~Leukemic blasts must not be present in the peripheral blood.~Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines with < 5% blasts and no Auer rods.~Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present"|Within one week of peripheral count recovery but no later than day 42||||participants|||Number
2708517|NCT01184898|Primary|Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC|"Percent change compared between response groups (responder vs nonresponder).~This outcome measure only includes patients who survived to outcome assessment."|From pre- to post-treatment||||percentage change in leukemic blasts||Full Range|Mean
2708588|NCT01184079|Secondary|Compliance With 3rd Dose|Determine the compliance of the men for the timing of the third dose.|at 3rd dose (i.e., at month 6 or month 12, depending on arm)||||participants|||Number
2708524|NCT01184872|Secondary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.|Baseline and 7 to 14 days after end of therapy|Population analyzed consisted of patients from the clinically evaluable population who had independent microbiological assessments.|||participants|||Number
2708525|NCT01184872|Primary|Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit|Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.|Baseline and 7 to 14 days after end of therapy|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for complicated skin and soft tissue, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.|||participants|||Number
2708526|NCT01184859|Secondary|Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)|Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.|Days 4- 32|Safety population which included all randomised and exposed participants. Participants were analysed according to the actual treatment received.|||participants|||Number
2708527|NCT01184859|Secondary|Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32|The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||units on a scale||Standard Deviation|Mean
2708528|NCT01184859|Secondary|Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32|N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||units on a scale||Standard Deviation|Mean
2708529|NCT01184859|Secondary|Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32|Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||nocturnal urine volume / 24-hour urine||Standard Deviation|Mean
2708530|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||ml/kg||Standard Deviation|Mean
2708531|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Volume at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||ml||Standard Deviation|Mean
2708589|NCT01184079|Primary|Immunogenicity After Dose 3|Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.|1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)|Intention-to-treat|||mM units/ml||95% Confidence Interval|Geometric Mean
2708532|NCT01184859|Secondary|Change From Baseline in Nocturnal Urine Volume at Approximately Day 32|Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||ml||Standard Deviation|Mean
2708533|NCT01184859|Secondary|Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32|Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||voids||Standard Deviation|Mean
2708534|NCT01184859|Secondary|Change From Baseline in Number of Daytime Voids at Approximately Day 32|Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||voids||Standard Deviation|Mean
2708535|NCT01184859|Secondary|Change From Baseline in Total Sleep Time at Approximately Day 32|"Total sleep time is defined as the time spent asleep from initial sleep to final awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||minutes||Standard Deviation|Mean
2708536|NCT01184859|Secondary|Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2|"Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||minutes||Standard Deviation|Mean
2708537|NCT01184859|Secondary|Time When Urine Production <0.12 ml/kg/Min|Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||hours||Standard Deviation|Mean
2708538|NCT01184859|Secondary|Area Under the Urine Production Curve (AUCurine Prod)|Area under the urine production curve, from dose administration to end of action (AUCurine prod)|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||h*mL||Standard Deviation|Mean
2708539|NCT01184859|Secondary|Area Under the Urine Osmolality Curve (AUCosm)|Area under the urine osmolality curve, from dose administration to end of action (AUCosm).|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||h*mOsm/kg||Standard Deviation|Mean
2708540|NCT01184859|Primary|Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2|Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||nocturnal voids||95% Confidence Interval|Least Squares Mean
2708541|NCT01184859|Primary|Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1|Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||hours||Standard Deviation|Mean
2708692|NCT01183143|Secondary|Number of Subjects With Live Birth|Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported.|End of Gestation period, assessed up to a maximum of 1 year|Per Protocol (PP) population was defined as the group of subjects who completed the study, having returned their completed questionnaire and who did not present any major protocol deviations.|||subjects|||Number
2708542|NCT01184846|Secondary|Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.|Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.|At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)|The SDS comprised all subjects treated with the study drug.|||participants|||Number
2708543|NCT01184846|Secondary|Mean Change in Body Temperature During Infusion|Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.|||°C||Standard Deviation|Mean
2708544|NCT01184846|Secondary|Mean Change in Pulse Rate During Infusion|Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug|||beats per minute||Standard Deviation|Mean
2708545|NCT01184846|Secondary|Mean Change in Systolic and Diastolic Blood Pressure During Infusion|Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.|||mm Hg||Standard Deviation|Mean
2708546|NCT01184846|Secondary|Relatedness of AEs Per Subject|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.|||percentage of subjects|||Number
2708547|NCT01184846|Secondary|Relatedness of AEs Per Infusion|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.|||AE rate per infusion|Participants||Number
2708548|NCT01184846|Secondary|Severity of AEs Per Subject|"The severity of each AE was to be graded by the investigator as follows:~Mild: Symptoms were easily tolerated and there was no interference with daily activities.~Moderate: Discomfort enough to cause some interference with daily activities.~Severe: Incapacitating with inability to work or do usual activity."|34 weeks|The SDS comprised all subjects treated with the study drug.|||percentage of subjects|||Number
2708549|NCT01184846|Secondary|Severity of AEs Per Infusion|"The severity of each AE was to be graded by the investigator as follows:~Mild: Symptoms were easily tolerated and there was no interference with daily activities.~Moderate: Discomfort enough to cause some interference with daily activities.~Severe: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.|||AE rate per infusion|Participants||Number
2708550|NCT01184846|Secondary|Frequency of Adverse Events (AEs)|Overall rate of AEs per infusion.|For the duration of the study, up to 34 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.|||AE rate per infusion|Participants||Number
2708551|NCT01184846|Secondary|Immunoglobulin G (IgG) Level||At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement.|||mg/dL||Standard Deviation|Mean
2708552|NCT01184846|Secondary|Change in Medical Research Council Sum Scale (MRC)|"The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.~The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.|||score on a scale||95% Confidence Interval|Mean
2708553|NCT01184846|Secondary|Change in Maximum Grip Strength|Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.|||kPa||95% Confidence Interval|Mean
2708562|NCT01184508|Secondary|Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)|The PGI-I was a 1-item scale that measured the participant's perception of improvement in migraine symptoms compared with the start of treatment. Scores ranged from 1 (very much improved) to 7 (very much worse). A score of 4 indicated no change.|Baseline (Day 28) and Week 12 (Day 84)|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||units on a scale||Full Range|Median
2708554|NCT01184846|Secondary|Change in Adjusted INCAT Score|"The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.~The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help'). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.|||score on a scale||95% Confidence Interval|Mean
2708555|NCT01184846|Primary|Responder Rate|"Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score.~Responders were defined as those subjects who: 1) demonstrated a clinically meaningful improvement between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with clinically meaningful improvement at the last study visit.~Clinically meaningful improvement was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0."|25 weeks|The full analysis set (FAS) includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. The valid cases set (VCS) consists of all FAS subjects without any major protocol deviation (ie, the subjects who participated in the study as intended).|||percentage of responders||95% Confidence Interval|Number
2708556|NCT01184755|Primary|Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)|The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.|8 weeks|These were patients who completed both the baseline and 8-week Ambulatory BP measures.|||mm Hg||Standard Deviation|Mean
2708557|NCT01184508|Other Pre-specified|Change From Baseline to 12 Week Endpoint in Breakthrough Treatment Therapy for Acute Migraine Attacks|Participants were allowed to use a pre-approved list of medications for the treatment of breakthrough migraines during the study, as long as the treatments were the same as those used and reported during the baseline period. Any medications or procedures to prevent migraines were not allowed. The mean number was calculated by the breakthrough (BH) medications (meds) per migraine used by each participant per month. Each month was normalized to a 28-day month.|Baseline, Week 12|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||BH meds/migraine by participants/month||Standard Deviation|Mean
2708558|NCT01184508|Secondary|Percentage of Participants Using Breakthrough Medications|Participants were allowed to use a pre-approved list of medications for the treatment of breakthrough migraines during the study, as long as the treatments were the same as those used and reported during the baseline period. Any medications or procedures to prevent migraines were not allowed. Percentage of participants = (number of participants using breakthrough medication/total number of participants)*100. Each month was normalized to a 28-day month.|Month 3|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||percentage of participants|||Number
2708559|NCT01184508|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve at the Steady State (AUCtau,ss) of LY2300559||Baseline and Week 8 (1 to 3 hours postdose), Weeks 2 and 4 (predose and 1 to 3 hours postdose), Week 12 (predose, 1 to 3 hours postdose, and 5 hours postdose)|Participants who received at least 1 dose of study drug and had at least 1 evaluable pharmacokinetic sample.|||nanogram*hours per milliliter (ng*h/mL)||95% Confidence Interval|Median
2708560|NCT01184508|Secondary|Change From Baseline to 12 Week Endpoint in Migraine Interictal Burden Scale (MIBS-4) Overall Weighted Score|MIBS-4 was a 4-item self-administered scale that assessed the impact of headaches on the participant's life between headache attacks. Each item measured a specific domain (impairment in work or school, impairment in family and social life, difficulty making plans or commitments, or emotional/affective and cognitive distress). For each item and domain, scores were weighted as follows: Don't know (0), Never (0), Rarely (1), Some of the time (2), Much of the time (3), and All of the time (4). The overall weighted score was the sum of the domain scores and ranged from 0 to 16. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.|Baseline and Week 12|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||units on a scale||Standard Deviation|Mean
2708561|NCT01184508|Secondary|Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score|The MSQ was a 14-item self-administered scale that assessed the participant's perception of quality of life for 3 dimensions [role restriction or restrictive function (Items 1-7), role prevention or preventive function (Items 8-11), and emotional function (Items 12-14)]. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recoded before item scores were calculated. Then, dimension scores were calculated as the sum of the recoded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain.|Baseline and Week 12|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||units on a scale||Standard Deviation|Mean
2708563|NCT01184508|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)|The CGI-I was a 1-item scale that measured the clinician's perception of the improvement in migraine symptoms compared with the start of treatment. Scores ranged from 1 (very much improved) to 7 (very much worse). A score of 4 indicated no change.|Baseline(Day 28) and Week 12 (Day 84)|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug and, for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||units on a scale||Full Range|Median
2708564|NCT01184508|Secondary|Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days|A migraine day was any day with a migraine attack (a headache lasting 4 to 72 hours). The number of migraine days per month was normalized to a 28-day month and calculated as the (number of migraine days*28)/number of days in the specified month.|Baseline and Month 3|Randomized participants (pts) who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||migraine days||Standard Deviation|Mean
2708565|NCT01184508|Secondary|Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms|The duration of migraine symptoms was the amount of time from the beginning of each individual migraine attack to the end of each migraine attack. Two attacks separated by <24 hours were considered part of the same migraine and duration was calculated as such. Migraine symptoms included photophobia, phonophobia, nausea, and vomiting. No data collected for aura and vomiting's migraine symptoms.|Baseline and Month 3|Randomized participants (pts) who had at least 4 migraines/probable migraines during the baseline period, who received at least 1 dose of study drug, and had at least 1 post-randomization efficacy data for the specified endpoint.No data collected for aura and vomiting’s migraine symptoms.|||hours||Standard Deviation|Mean
2708566|NCT01184508|Secondary|Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)|The participant-reported severity of migraines was rated on a 3-point categorical scale (Mild, Moderate, or Severe). Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication. If a participant had multiple migraines during Month 3 (normalized to 28 days), the most severe migraine was analyzed.|Baseline and Month 3|Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.|||participants|||Number
2708567|NCT01184508|Primary|Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks|The definition of a migraine (a headache lasting 4 to 72 hours) was based on the International Headache Society (IHS) diagnostic criteria. The number of migraine attacks per month was normalized to a 28-day month and calculated as the (number of migraine attacks*28 days)/number of days in the specified month.|Baseline and Month 3|Randomized participants (pts) who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom had at least 1 post-randomization efficacy data for the specified endpoint was available.|||migraine attacks||Standard Deviation|Mean
2708568|NCT01184456|Primary|Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues|"The primary endpoint measurement of safety is measured based on the number of adverse events reported relative to the expected number adverse events prior to the start of the study based on a risk analysis.~The primary endpoint measurement of immune function is measured based on biological markers including CRP, IL-8 and TNF-alpha between the two groups.~The primary endpoint measurement of gastro-intestinal issues is measured based on the number of reported symptoms relative to the expected number of gastro-intestinal issues prior to the start of the study based on a risk analysis."|30, 60, and 90 days.|PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.||||||
2708569|NCT01184417|Secondary|Number of Study Patients With Mortality as a Measure of Safety and Tolerability|mortality in study patients|1 year||||participants|||Number
2708570|NCT01184417|Secondary|Number of Study Patients With Seizure as a Measure of Safety and Tolerability|Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).|1 year||||participants|||Number
2708571|NCT01184417|Secondary|Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability|"Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a bedside sitter to observe the patient and provide additional safety supervision during any portion of their hospitalization."|1 year||||percentage of participants|||Number
2708572|NCT01184417|Secondary|Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability|"The outome answeres the question Did the study patient require endotracheal intubation, or not. This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation."|1 year||||participants|||Number
2708573|NCT01184417|Secondary|Length of Stay|hospital LOS, per patient, in hours from admission to discharge|1 year||||hours||Inter-Quartile Range|Median
2708574|NCT01184417|Primary|Total Lorazepam Required Per Patient Per Admission|How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.|1 year||||milligrams||Standard Deviation|Mean
2708575|NCT01184417|Primary|Percentage of Patients Requiring ICU Admission|admission to intensive care unit|1 year||||percentage of participants|||Number
2708576|NCT01184417|Primary|Number of Patients Requiring Continuous Lorazepam Infusion|"All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or lorazepam drip). Thus, continuous lorazepam infusion is a yes or no variable (i.e. continuous infusion, or not)."|1 year||||participants|||Number
2709007|NCT01181011|Primary|Cmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs|All patients with values for Cmax of Amlodipine|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2708577|NCT01184326|Secondary|Grade 4 Treatment-Related Toxicity Rate [Expansion]|Grade 4 treatment-related toxicity rate is the percentage of participants experiencing at least one treatment-related grade 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.|Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; Treatment duration was up to 10 cycles in the expansion cohort (1 cycle=28 days).|All phase I expansion participants who received at least one dose of the study drug were evaluable for toxicity.|||percentage of participants||95% Confidence Interval|Number
2708578|NCT01184326|Secondary|Mean Duration of Response [Expansion]|Duration of response was calculated as the time from achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment until disease progression. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; PFS follow-up was up to 9.2 months in the expansion cohort.|The duration of response is only estimated in the phase 1 expansion participants who achieved objective response on treatment.|||months||Full Range|Mean
2708579|NCT01184326|Secondary|Median Progression-Free Survival [Expansion]|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; PFS follow-up was up to 9.2 months in the expansion cohort.|The analysis population is comprised of all enrolled Phase 1 expansion participants.|||months||95% Confidence Interval|Median
2708580|NCT01184326|Secondary|Grade 4 Treatment-Related Toxicity Rate [Dose Finding]|Grade 4 treatment-related toxicity rate is the percentage of participants experiencing at least one treatment-related grade 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.|Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; Treatment duration was up to 6 cycles in the Dose Level 0 cohort and 14 cycles in the Dose Level -1 cohort (1 cycle=28 days).|All phase I dose finding participants who received at least one dose of the study drug were evaluable for toxicity.|||percentage of participants||95% Confidence Interval|Number
2708581|NCT01184326|Primary|Objective Response Rate [Expansion]|The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|TDisease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment duration was up to 6 cycles in the Dose Level 0 cohort, 14 cycles in the Dose Level -1 cohort and 10 cycles in the expansion cohort (1 cycle=28 days).|The analysis population is comprised of all enrolled Phase 1 expansion participants.|||percentage of participants||95% Confidence Interval|Number
2708582|NCT01184326|Primary|Dose Limiting Toxicity (DLT) [Phase I Dose Finding]|A DLT was defined as an adverse event (a) with treatment attribution of possible, probable, or definite, and (b) occurs during cycle 1, and (c) meets any of the following criteria: Grade 3 or 4 non-hematologic toxicity excluding: nausea/vomiting controlled with antiemetics, Grade 3 hypertension that resolves to ≤150/90 within 7 days with supportive care, and Grade 3 asymptomatic, clinically insignificant laboratory abnormalities (LDH, alkaline phosphatase due to bone metastases, and asymptomatic hypophosphatemia). Hematologic toxicity: Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, Grade 4 neutropenia which persists for >7 days, Grade 4 neutropenia associated with fever >38.5C; Hematologic toxicity excluded lymphopenia or anemia of any grade. Missing more than 5 days of planned doses for drug-related intolerable grade 2 toxicity;Toxicity related to therapy severe enough to require a dose-reduction.|Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for DLT evaluation was the first 28 days of treatment.|All phase I dose finding participants who received at least one dose of the study drug were evaluable for DLT.|||Participants|||Count of Participants
2708583|NCT01184326|Primary|Maximum Tolerated Dose (MTD) [Phase I Dose Finding]|The MTD of Pazopanib in combination with Everolimus 5 mg PO QD was determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for MTD evaluation was the first 28 days of treatment.|All phase I dose finding participants who received at least one dose of the study drug were evaluable for MTD.|||mg|||Number
2708584|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment.|The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth. Anterior tongue strength (KPa) reported. Subjects were divided into 3 subgroups: improved (lower anterior tongue strength KPa), unchanged, or worsened (higher anterior tongue strength KPa).|16 weeks||||participants|||Number
2709008|NCT01181011|Primary|AUC_0-∞ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Amlodipine|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2708590|NCT01184053|Secondary|Associations Between Markers of Angiogenesis (e.g. VEGF) With Response|We will request a blood sample to measure vascular endothelial growth factor (VEGF) as well as other angiogenic factors and correlate levels to response to arsenic trioxide. Such effects have been observed in cultured cell lines and animal models, as well as clinical studies.|4 years|No patients achieved a CR or PR response, no angiogenesis was performed.||||||
2708591|NCT01184053|Secondary|Overall Survival||5 years|All patients who received treatment|||days||95% Confidence Interval|Median
2708592|NCT01184053|Secondary|Progression Free Survival in Patients Treated With Trisenox®|Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.|28 days||||Participants|||Count of Participants
2708593|NCT01184053|Primary|Objective Response (CR+PR) Rate of Subjects Given Trisenox|To estimate the objective response (CR+PR) rate (as defined by the Gynecologic Oncology Group [GOG] RECIST Criteria)of Trisenox® in women with recurrent or metastatic endometrial cancer when administered at 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks.|28 days||||Participants|||Count of Participants
2708594|NCT01184014|Primary|Mean Blood Glucose of All Readings|Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days|starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days||||mg/dL||Standard Deviation|Mean
2708595|NCT01183975|Primary|Mean Excess Weight Change|Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).|3 years follow up||||percent change in excess weight||Standard Deviation|Mean
2708596|NCT01183975|Primary|Mean BMI Change|Mean change in BMI for valid subjects|3 years follow-up|517 valid patients analyzed|||kg/m^2||Standard Deviation|Mean
2708597|NCT01183923|Primary|Change in Forced Expiratory Volume at One Second (FEV1)|The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.|30 days|Trial was halted due to an adverse event after the second intervention. The participant could not complete the second challenge for data to be obtained.|||percent change|||Number
2708598|NCT01183897|Secondary|Monitor Safety of the High-dose Antibody Treatment|to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.|2 years|Data were not collected||||||
2708599|NCT01183897|Secondary|Apply Real-time Quantitative RT-PCR|to test the hypothesis that the minimal residual disease content of bone marrow after the first treatments with 3F8/GMCSF has significant prognostic impact on progression-free survival.|2 years|Data were not collected||||||
2708600|NCT01183897|Primary|Assess the Activity of High-dose 3F8/GM-CSF|against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.|2 years|Data were not collected||||||
2708601|NCT01183884|Secondary|Monitor Safety of the High-dose Antibody Treatment|to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.|2 years|Data not collected||||||
2708602|NCT01183884|Secondary|Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow|after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.|2 years|Data not collected||||||
2708603|NCT01183884|Primary|Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival|in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.|2 years|Data not collected||||||
2708604|NCT01183858|Secondary|Overall Survival (OS) at the End of Study|OS defined as the time from randomization to the date of death due to any cause.|Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||months||95% Confidence Interval|Median
2708605|NCT01183858|Primary|Progression-Free Survival (PFS) at the End of Study|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||weeks||95% Confidence Interval|Median
2708606|NCT01183858|Secondary|Number of Participants With Adverse Events (AEs) at the End of the Study|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death."|Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)|Safety population included all randomized participants who received at least one dose of study drug.|||participants|||Number
2708607|NCT01183858|Secondary|Time to Progression (TTP)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||weeks||95% Confidence Interval|Median
2708608|NCT01183858|Secondary|Disease Control Rate (DCR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||percentage of participants||95% Confidence Interval|Number
2708609|NCT01183858|Secondary|Overall Response Rate (ORR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||percentage of participants||95% Confidence Interval|Number
2708610|NCT01183858|Secondary|Overall Survival (OS)|OS defined as the time from randomization to the date of death due to any cause.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||months||95% Confidence Interval|Median
2708611|NCT01183858|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||weeks||95% Confidence Interval|Median
2708612|NCT01183780|Secondary|Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab||Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17|All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.|||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2708613|NCT01183780|Secondary|Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.|Cycles 1, 3, 5, and 30-Day FU|All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.|||percentage of participants|||Number
2708614|NCT01183780|Secondary|Change From Baseline in EuroQol- 5D (EQ-5D)|The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline and 30-Day Follow-Up (FU) up to 171 Weeks|All randomized participants who had EQ-5D assessed at baseline and 30-day FU.|||units on a scale||Standard Deviation|Mean
2708615|NCT01183780|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status|The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.|Baseline Up to 171 Weeks|All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .|||units on a scale||Standard Deviation|Mean
2708616|NCT01183780|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.|Randomization until Disease Progression Up to 38.01 Months|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2708631|NCT01183689|Secondary|General Health Index|"The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes.~Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention"|Changes from baseline to 2 years||||2 year changes in units on a scale||Standard Error|Mean
2708617|NCT01183780|Secondary|Progression-free Survival (PFS) Time|PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.|Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.|||months||95% Confidence Interval|Median
2708618|NCT01183780|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.|Randomization to Date of Death from Any Cause Up to 39.36 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.|||months||95% Confidence Interval|Median
2708619|NCT01183728|Secondary|Indication of Efficacy|"Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.~Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.~Mean (SD) are expressed as the percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100."|0, 6, 12, 24 months||||percentage of values||Standard Deviation|Mean
2708620|NCT01183728|Primary|Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.|"Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)).~In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome.~VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities."|0, 3, 6, 12 and 24 months||||units on a scale||Standard Deviation|Mean
2708621|NCT01183689|Other Pre-specified|6 Year Weight Changes|Changes from baseline to year 6 in body weight|6 years|||||||
2708622|NCT01183689|Secondary|Self-weighing|Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week|2 years||||Participants|||Count of Participants
2708623|NCT01183689|Secondary|Change in Waist Circumference (cm)|Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.|Change from baseline to 2 years||||centimeters||Standard Error|Mean
2708624|NCT01183689|Secondary|Total Energy Dietary Intake Per Day (Kcals)|"Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy.~REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335."|Changes from baseline to 2 years in kilocalories||||kilocalories||Standard Error|Mean
2708625|NCT01183689|Secondary|Insulin Resistance|We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL).|Change from baseline to 2 years||||HOMA-IR||Standard Error|Mean
2708626|NCT01183689|Secondary|Depression Symptomatology|Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.|2 years|All Participants with 2 year data|||units on a scale||Standard Error|Mean
2708627|NCT01183689|Secondary|Mean Change in Fasting Insulin From Baseline to 2 Years|Mean change in fasting insulin (uU/ml) from baseline to 2 years|2 years||||Mean changes at 2 years in uU/ml||Standard Error|Mean
2708628|NCT01183689|Secondary|Mean Change in Fasting Glucose From Baseline to 2 Years|Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures|2 years|All participants with measurements at 2 years|||Mean change from baseline in mg/dl||Standard Error|Mean
2708629|NCT01183689|Secondary|Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)|Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)|2 years|Mean changes from baseline among all participants with year 2 measures|||Mean change in LDL-C in mg/dl||Standard Error|Mean
2708630|NCT01183689|Secondary|Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)|Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance|2 years|Mean changes among all participants with measurements at Year 2|||Mean Change from Baseline in mg/dl||Standard Error|Mean
2708713|NCT01183013|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS with non-completers (without a value at Week 30) considered as failure|||participants|||Number
2708632|NCT01183689|Secondary|Rigid Dietary Control|"Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control.~REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation."|Changes from baseline to 2 years||||2 year changes in units on a scale||Standard Error|Mean
2708633|NCT01183689|Secondary|Flexible Dietary Control|"Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control.~REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64."|Changes from baseline to 2 years||||units on a scale||Standard Error|Mean
2708634|NCT01183689|Secondary|Disinhibition|"The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition).~REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation."|Changes at 2 years||||Units on a scale||Standard Error|Mean
2708635|NCT01183689|Secondary|Dietary Restraint: Mean Change From Baseline to 2 Years|"The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint).~Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation."|2 years||||Units on a scale||Standard Error|Mean
2708636|NCT01183689|Secondary|Obesity|Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.|3 years||||percentage of participants||Standard Error|Mean
2708637|NCT01183689|Secondary|Mean Changes From Baseline to 2 Years in Total Cholesterol|Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)|2 years|All participants with Year 2 measures|||mg/dl||Standard Error|Mean
2708638|NCT01183689|Secondary|Mean Changes From Baseline in Diastolic Blood Pressure|Change from baseline to 2 years in diastolic blood pressure|2 years|All participants providing data at 2 years|||mmHg||Standard Error|Mean
2708639|NCT01183689|Secondary|Mean Changes in Systolic Blood Pressure|Compare changes in systolic blood pressure across the three intervention groups|Measured at 2 Years|All participants with measurements at Year 2|||mmHg||Standard Error|Mean
2708640|NCT01183689|Secondary|Mean Weight Changes|Mean differences in weight changes among intervention groups at 24 months post-randomization|2 years||||kilograms||Standard Error|Mean
2708641|NCT01183689|Secondary|Weight Gain 1 Pound or More at Any Time Over Follow-up|Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.|3 years||||percentage gaining 1 pound or more among||Standard Error|Mean
2708642|NCT01183689|Primary|Weight Changes From Baseline Over Follow-up.|Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.|3 years||||kilograms||Standard Error|Mean
2708643|NCT01183650|Primary|Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants|||hours||Full Range|Median
2708644|NCT01183650|Primary|Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2708645|NCT01183650|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710|AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.|1 day and 10 days|All enrolled participants|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2708646|NCT01183546|Secondary|Shoulder Peak Resultant Moment|Shoulder Peak Resultant Moment during wheelchair transfers was calculated using an inverse dynamics model approach. Inputs into the model included forces recorded at the hands during transfers, three-dimensional motion trajectories of markers placed on the upper limbs and trunk, and subject's anthropometric data.|Baseline Testing and at Followup Testing (4 weeks)||||Newton-meter/kilogram||Standard Deviation|Mean
2708647|NCT01183546|Primary|Transfer Performance (TAI Scores Part 1)|"Part 1 of the TAI is comprised of 15 items which are scored yes (1 point) when the subject performs the specified skill correctly and no (0 points) when the subject performs the skill incorrectly or (N/A) which means the item does not apply. The part 1 summary score is the summation of each item's score multiplied by 10, and then divided by the number of applicable items, ranging from 0 to 10."|Baseline Testing and at Followup Testing (4 weeks)||||units on a scale||Standard Deviation|Mean
2708648|NCT01183533|Secondary|Mortality||90 days|Note: although 2 patients were not available for complete day 90 assessments, family/patient communication provided necessary mortality information.|||participants|||Number
2708714|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c >=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF)|||participants|||Number
2708649|NCT01183533|Secondary|90-day Modified Rankin Scale (mRS) Score 0 or 1|Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.|90 days|^ Note: 2 patients were not available for 90-day follow-up assessments.|||participants|||Number
2708650|NCT01183533|Primary|Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients|The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.|24 hours||||cases.|||Number
2708651|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing multiple fraction treatment|||percentage of participants|||Number
2708652|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed.~Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame."|During radiotherapy (5 days) and the 24 hours following radiotherapy|Patients undergoing multiple fraction treatment|||percentage of participants|||Number
2708653|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing single fraction treatment|||percentage of participants|||Number
2708654|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries."|Day of radiotherapy and 24 hours following|Patients undergoing single fraction treatment|||percentage of participants|||Number
2708655|NCT01183481|Secondary|The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication .|Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.|From day of radiotherapy to 10 days following radiotherapy|||||||
2708656|NCT01183481|Primary|The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).|Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.|Days 2-10 following radiotherapy||||participants|||Number
2708657|NCT01183468|Primary|C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52|No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.|Week 52|Enrolled Sample||||||
2708658|NCT01183429|Secondary|Monitor Safety of the High-dose Antibody Treatment|to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.|2 years|No data were collected||||||
2708659|NCT01183429|Secondary|Apply Real-time Quantitative RT-PCR|to test the hypothesis that the minimal residual disease content of bone marrow after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.|2 years|No data were collected||||||
2708660|NCT01183429|Primary|Assess the Impact of High-dose 3F8/GM-CSF|on relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.|2 years|No data were collected||||||
2708661|NCT01183416|Secondary|Monitor Safety of the High-dose Antibody Treatment|to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.|2 years|Data were not collected||||||
2708662|NCT01183416|Secondary|Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow|after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.|2 years|Data were not collected||||||
2708663|NCT01183416|Primary|Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival|in patients who are post-stem-cell transplantation and in first complete or very good partial remission, but at high risk of relapse.|2 years|Data were not collected||||||
2708664|NCT01183390|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2708665|NCT01183390|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2708766|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708666|NCT01183312|Secondary|Electroencephalogram (EEG) Power|EEG signals reflect the state of excitability of the cerebral cortex and correlate highly with levels of behavioral arousal. This is quantifiable as 'power' of the signal (microvolts squared/signal frequency). The EEG signals will be acquired and stored for off-line power analysis and comparison between treatment conditions.|following drug administration|EEG signal processing analyses have not been performed. This would require an additional set of extensive analyses, very distinct from the statistics performed for the other study outcomes. EEG data were collected for possible future analyses, pending resources and expertise, and as such we have no data to report here.||||||
2708667|NCT01183312|Secondary|Change in Stanford Sleepiness Scale|The Stanford Sleepiness Scale (SSS) is a subjective rating of sleepiness, with score ranging from 1 to 7, where higher values reflect more severe sleepiness. The measure used was change in SSS from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||units on a scale||Standard Deviation|Mean
2708668|NCT01183312|Secondary|PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT|At the end of the 10 minute PVT testing period, subjects were asked to rate their current level of sleepiness along a line, which was transformed into a numeric value from 1-10, such that high levels indicated more severe subjective sleepiness. The measure used was the change in this rating from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||units on a scale||Standard Deviation|Mean
2708669|NCT01183312|Secondary|PVT Additional Measure #4, Change in False Response Frequency|The false response frequency is defined as the number of button presses when no stimulus is presented. The measure used was the change in false response frequency from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||number of false starts||Standard Deviation|Mean
2708670|NCT01183312|Secondary|PVT Additional Measure #3, Change in Optimum Response Times|The optimum response times is defined as the reciprocal of the reaction time averaged across the fastest 10% of responses. The measure used was the change in optimum response time from baseline to following drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||1/msec||Standard Deviation|Mean
2708671|NCT01183312|Secondary|PVT Additional Measure #2, Change in Duration of Lapse Domain|The PVT duration of lapse domain is defined as the reciprocal of the reaction time averaged across the slowest 10% of responses. The measure used was the change in duration of lapse domain from baseline to drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||1/msec||Standard Deviation|Mean
2708672|NCT01183312|Secondary|PVT Additional Measure #1, Change in Lapse Frequency|A PVT lapse is defined as a reaction time exceeding 500 msec following the presentation of a single stimulus, which are then summed for the entire 10 minute PVT testing period. The measure used was the change in the frequency of lapses from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||number of lapses during PVT testing||Standard Deviation|Mean
2708673|NCT01183312|Primary|Change in Psychomotor Vigilance Task (PVT) Median Reaction Time|The PVT measures the reaction time to button press following the presentation of a visual stimulus, reported here as the median reaction time for multiple presentations during the 10 minute task. The measure used was the change in median reaction time from baseline to drug administration, where the median reaction time at each of the time points (below) was averaged to provide a single on-treatment value for median reaction time. The measure was then calculated as baseline value - treatment value, such that higher numbers denote improvement from baseline.|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||msec||Standard Deviation|Mean
2708674|NCT01183260|Secondary|Functional and General Health Outcome Assessments|"Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems:~SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health.~SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health.~HOOS Pain assesses pain in the hip~HOOS Symptoms assesses symptoms such as stiffness in the hip~HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.)~HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.)~HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life"|2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative|"By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group:~We were unable to contact 1 patient from each group in order to schedule follow-up"|||units on a scale||Standard Deviation|Mean
2708690|NCT01183143|Secondary|Number of Subjects With at Least 1 Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerged or worsened relative to baseline (i.e. present at the initial study visit) during a clinical study with an investigational product, regardless of causal relationship and even if no investigational product has been administered.|Up to 1 year|The tolerance analysis set included of all the subjects who were presented at the inclusion visit.|||subjects|||Number
2708675|NCT01183260|Primary|Periprosthetic Bone Mineral Density (BMD) of Hip|Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.|2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative|"By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group:~We were unable to contact 1 patient from each group in order to schedule follow-up The remaining patients were withdrawn because they were feeling fine and declined to return for follow-up at that time"|||g/cm^2||Standard Deviation|Mean
2708676|NCT01183234|Primary|Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set|||hours||Full Range|Median
2708677|NCT01183234|Primary|Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set|||ng/ml||90% Confidence Interval|Least Squares Mean
2708678|NCT01183234|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)|AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|Pharmacokinetic analysis set (PK) defined as all subjects in the safety analysis set who had evaluable plasma concentration-time profiles for MPH through 24 hours post-dosing in both treatment periods. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded.|||ng*h/ml||90% Confidence Interval|Least Squares Mean
2708679|NCT01183169|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.|within 24 weeks after treatment|FAS For Efficacy|||percentage of participants|||Number
2708680|NCT01183169|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"On-treatment viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment"|within 48 weeks|FAS For Efficacy|||percentage of participants|||Number
2708681|NCT01183169|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End||Up to 48 weeks|Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point|||percentage of participants|||Number
2708682|NCT01183169|Secondary|Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD|ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.|within 48 weeks|FAS For Efficacy|||percentage of participants|||Number
2708683|NCT01183169|Secondary|Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD|pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy|||percentage of participants|||Number
2708684|NCT01183169|Secondary|Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD|RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.|after 4 weeks of treatment|FAS For Efficacy|||percentage of participants|||Number
2708685|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD|SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.|24 weeks after treatment|FAS For Efficacy|||percentage of participants|||Number
2708686|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD|SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.|12 weeks after treatment|FAS For Efficacy|||percentage of participants|||Number
2708687|NCT01183169|Secondary|Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)|cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy|||percentage of participants|||Number
2708688|NCT01183169|Primary|Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)|cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment|||percentage of participants|||Number
2708689|NCT01183143|Secondary|Number of Subjects Taking at Least 1 Concomitant Treatment||Up to 1 year|The tolerance analysis set included of all the subjects who were presented at the inclusion visit.|||subjects|||Number
2708691|NCT01183143|Secondary|Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator|Local tolerance at the GONAL-f ® injection site was assessed for the presence of pain, swelling/welt, redness, itch and haematoma.|Up to 1 year|ITT population included all the subjects who received at least 1 dose of the investigational medicinal product.|||subjects|||Number
2708693|NCT01183143|Secondary|Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)|Pregnancy rate was defined as the percentage of subjects with diagnosis of pregnancy, who underwent OI/IUI. Clinical pregnancy: Evidence of pregnancy by clinical or ultrasound parameters at 12 weeks after fertilization. Biochemical pregnancy: Evidence of conception based only on biochemical data in the serum or urine before ultrasound evidence of a gestational sac. Ongoing pregnancy was defined when the pregnancy had completed 20 weeks of gestation.|Up to 20 Weeks of Gestation|"The ITT population included all the subjects who received, at least 1 dose of the IMP. Number of Participants Analyzed signifies ITT (OI/IUI) subjects who were evaluable for this outcome measure."|||Percentage of subjects||95% Confidence Interval|Number
2708694|NCT01183143|Secondary|Total and Average Daily Dose of GONAL-f®||Up to 26 days|The ITT population included all the subjects who received at least 1 dose of the IMP.|||International Units (IU)||Standard Deviation|Mean
2708695|NCT01183143|Secondary|Mean Number of Embryos Transferred||End of Stimulation period (up to a maximum 26 days)|"The ITT population included all the subjects who received at least 1 dose of the IMP. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||embryos||Standard Deviation|Mean
2708696|NCT01183143|Secondary|Duration of Ovarian Stimulation With GONAL-f®|Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.|Up to 1 year|The ITT population included all the subjects who received, at least 1 dose of the IMP.|||days||Full Range|Median
2708697|NCT01183143|Secondary|Evaluation of the Information Given to the Subjects on the Pen's Utilization|Subjects were provided with the information on Pen's utilization via training session and in the form of information brochure. Subjects assessed both the methods using the following responses: satisfactory, satisfactory, unsatisfactory and very unsatisfactory.|Up to 1 year|"The ITT population. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome and Number Analyzed signifies those who were evaluable for the specified category."|||subjects|||Number
2708698|NCT01183143|Secondary|Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator|Investigator evaluated the use of GONAL-f® prefilled pen in subjects as very satisfactory, satisfactory and average satisfaction.|Up to 1 year|"The ITT population included all the subjects who received at least 1 dose of the IMP. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome."|||subjects|||Number
2708699|NCT01183143|Primary|Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)|Number of subjects who self-administered the IMP were presented in this outcome measure.|Up to 1 year|The ITT population included all the subjects who received at least 1 dose of the IMP.|||subjects|||Number
2708700|NCT01183104|Secondary|Change From Baseline in Body Weight at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.|||kg||Standard Deviation|Mean
2708701|NCT01183104|Secondary|Change From Baseline in Insulin/Proinsulin Ratio at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.|||ratio||Standard Deviation|Mean
2708702|NCT01183104|Secondary|Change From Baseline in HOMA-β at 52 W|β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]|Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.|||percent||Standard Deviation|Mean
2708703|NCT01183104|Secondary|The Number of Participants Achieving HbA1c < 6.9 %||52 W|Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W.|||Participants|||Count of Participants
2708704|NCT01183104|Primary|Number of Participants With Hypoglycaemia||From baseline to 52 W|Analysis set of evaluation for safety.|||Participants|||Count of Participants
2708705|NCT01183104|Primary|Change From Baseline in HbA1c at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set.|||percent||95% Confidence Interval|Least Squares Mean
2708706|NCT01183065|Primary|To Determine the Overall Response Rate (CR+PR)|by RECIST version 1.1 criteria|2 years||||participants|||Number
2708707|NCT01183013|Secondary|Incidence of Rescue Therapy During the First 30 Weeks of Treatment|Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.|30 weeks|FAS|||participants|||Number
2708708|NCT01183013|Secondary|Time to First Use of Rescue Therapy|Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.|30 weeks|FAS|||Proportion of participants|||Number
2708709|NCT01183013|Secondary|Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)|The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.|Baseline and 30 weeks|MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available.|||mg/dL||Standard Error|Least Squares Mean
2708710|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)|||mg/dL||Standard Error|Mean
2708711|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment|The change from baseline is the FPG after 30 weeks minus the baseline FPG.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30.|||mg/dL||Standard Error|Mean
2708712|NCT01183013|Secondary|HbA1c Change From Baseline by Visit Over Time|"HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.~by visit interaction."|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)|||percent||Standard Error|Mean
2709009|NCT01181011|Primary|AUC_0-tz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Amlodipine|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2708715|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF).|||participants|||Number
2708716|NCT01183013|Primary|Change From Baseline in HbA1c After 30 Weeks of Treatment.|HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.|||percent||Standard Error|Mean
2708717|NCT01182844|Secondary|IL-10||3 months||||pg/mL||Inter-Quartile Range|Median
2708718|NCT01182844|Secondary|IL-6||3 months||||pg/mL||Inter-Quartile Range|Median
2708719|NCT01182844|Secondary|oxLDL||3 months||||mU/mL||Standard Deviation|Mean
2708720|NCT01182844|Secondary|Gut Permeability|Lactulose/Mannitol test|3 months||||no unit - ratio||Standard Deviation|Mean
2708721|NCT01182844|Secondary|Change in Indices of Glucose Tolerance and Insulin Resistance|change in indices of glucose tolerance and insulin resistance (frequently sampled in an oral glucose tolerance test) at baseline and after 3 months|3 months||||no unit - indices||Standard Deviation|Mean
2708722|NCT01182844|Primary|Change of Burst (%)|"The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using FITC-labelled opsonized E. coli bacteria.~The Phagoburst® kit (Orpegen Pharma, Heidelberg, Germany) is used to determine the percentage of neutrophils that produce reactive oxidants with or without stimulation."|3 months||||percent||Standard Deviation|Mean
2708723|NCT01182844|Primary|Change of Neutrophil Phagocytosis|"The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using FITC-labelled opsonized E. coli bacteria.~The Phagoburst® kit (Orpegen Pharma, Heidelberg, Germany) is used to determine the percentage of neutrophils that produce reactive oxidants with or without stimulation."|3 months||||percent||Standard Deviation|Mean
2708724|NCT01182805|Primary|Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler|E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.|Assessed from echo obtained at time of enrollment|Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.|||cm/sec||Standard Deviation|Mean
2708725|NCT01182805|Primary|Diastolic Circumferential Strain Rate During Isovolumic Relaxation|Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.|Assessed from echo obtained at time of enrollment|Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.|||1/sec||Standard Deviation|Mean
2708726|NCT01182727|Primary|Side Effects of Salsalate|This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.|6 weeks|All subjects who completed the study were analyzed.|||participants|||Number
2708727|NCT01182675|Secondary|Number of Patients Who Achieve Engraftment of Donor T-cells in Blood by STR Testing|We will measure whether we are able to detect donor T-cells in the patient's blood after HSCT.|1 Year|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
2708728|NCT01182675|Secondary|Number of Patients With Engraftment of Donor Stem Cells in Bone Marrow by STR Testing|We will measure whether we are able to detect donor stem cells in the patient's bone marrow after HSCT.|1 Year|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
2708729|NCT01182675|Secondary|Percentage of Patients Who Become Independent From Regular IVIG Infusion|Based on B-cell function assays from the patient's blood, we will be able to determine if patients are able to successfully discontinue IVIG infusions.|2 Years|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
2708730|NCT01182675|Secondary|Incidence of Chronic GVHD||2 Years|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
2708731|NCT01182675|Secondary|Incidence of Acute GVHD||100 Days|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||participants|||Number
2708732|NCT01182675|Primary|Engraftment of Donor B-cells in Blood by STR Testing|Number of participants in whom donor B cells were detected in the patient's blood after HSCT.|1 Year|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||participants|||Number
2708733|NCT01182610|Secondary|Survival||2-year survival from first dose of panitumumab|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
2708734|NCT01182610|Secondary|Thirty-day Surgical Mortality|All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.|From date of surgery to 30 days after date of surgery|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
2708767|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708735|NCT01182610|Secondary|Resection Rate of Surgery|"The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H&E)examination, and the operative report indicates complete resection with no residual disease.~The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H&E) examination, and the operative report indicates complete resection with no residual disease.~The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease."|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
2708736|NCT01182610|Secondary|Pathologic Response Rate|The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H&E) examination.|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
2708737|NCT01182610|Primary|Response Rate|The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.|From the start of study treatment until restaging evaluation performed between days 36 to 43|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
2708738|NCT01182493|Secondary|Safety - Diabetic Ketoacidosis Incidence|Diabetic Ketoacidosis incidence during the study|6 Months||||Participants|||Count of Participants
2708739|NCT01182493|Secondary|Change in Body Weight|Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight|6 months||||kg||Standard Deviation|Mean
2708740|NCT01182493|Secondary|Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)|Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores|6 months||||score||Standard Deviation|Mean
2708741|NCT01182493|Secondary|Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)|Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline|6 months||||mg/dL/min||Standard Deviation|Mean
2708742|NCT01182493|Secondary|Safety - Severe Hypoglycemia Incidence|Severe hypoglycemia incidence during the study|6 months||||Participants|||Count of Participants
2708743|NCT01182493|Secondary|Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)|Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline|6 months||||mg/dL/min||Standard Deviation|Mean
2708744|NCT01182493|Primary|Between Group Difference in HbA1c When Comparing CSII to MDI|To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline|baseline and 6 months||||Change in % HbA1c||Standard Deviation|Mean
2708745|NCT01182480|Secondary|Glycemic Control|Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.|3 months|||||||
2708746|NCT01182480|Secondary|Perceived Self-efficacy|As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention|3 months|||||||
2708747|NCT01182480|Secondary|Appointment Attendance|As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups|3 months|||||||
2708748|NCT01182480|Primary|Patient Engagement|Patient engagement was assessed by patient text message response rates and average response times. Response rates were calculated as a percentage from the number of patient-initiated text messages sent in response to a system-generated request for information (the numerator) divided by the total number of system-generated requests for information (the denominator). Average response times were calculated from system-recorded time stamps for outbound requests sent and inbound patient-initiated responses received.|3 months|Group of study participants who received the text message intervention over a 3-month period.|||text message response rate (percent)|||Number
2708749|NCT01182441|Primary|Composite of Ischemic Stroke or Systemic Embolism|Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization|Day 8 to 18-months||||Probability of events within 18-months|||Number
2708768|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708750|NCT01182441|Primary|Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)|The endpoint was analyzed using a Bayesian piecewise exponential model with the historical priors based on data from the previous pivotal study PROTECT AF. This was a non-inferiority design with comparison of rate ratio of 18-month event rates of the Device and Control groups. The 18-month rate represents the probability of an event occurring within 18 months, and the 18-month rate ratio is a mean of the rate ratios. The primary endpoint was based on a calculation of the probability of events at 18 months but the statistical piecewise hazards model does not require the observation of any subjects out to 18-months.|18 month rate||||Probability of events within 18 months|||Number
2708751|NCT01182441|Primary|Primary Safety Endpoint (Device Group Only)|7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.|7-Day||||Participants|||Count of Participants
2708752|NCT01182428|Secondary|Persisting Dissection|All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
2708753|NCT01182428|Secondary|Thrombus|All subjects with thrombus of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
2708754|NCT01182428|Secondary|Aneurysm|All subjects with aneurysm of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||% of target lesions with aneurysm|Participants|95% Confidence Interval|Number
2708755|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708756|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708757|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708758|NCT01182428|Secondary|In-segment Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||% diameter stenosis|Participants|Standard Deviation|Mean
2708759|NCT01182428|Secondary|In-stent Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||% diameter stenosis|Participants|Standard Deviation|Mean
2708760|NCT01182428|Secondary|In-segment Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||Percentage of target lesions|Participants|95% Confidence Interval|Number
2708761|NCT01182428|Secondary|In-stent Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||Percentage of Target Lesions|Participants|95% Confidence Interval|Number
2708762|NCT01182428|Secondary|In-segment Late Loss (LL)|LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up|at 270 days|The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||millimeters|Participants|Standard Deviation|Mean
2708763|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708764|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708765|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708769|NCT01182428|Primary|In-stent Late Loss (LL) (Main Secondary Endpoint)|In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.|at 270 days|The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||millimeters|Participants|Standard Deviation|Mean
2708770|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708771|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708772|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708773|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708774|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708775|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable, Possible)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
2708776|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.|||Percentage of Participants||95% Confidence Interval|Number
2708777|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||1 to 30 days (Sub-Acute)|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
2708778|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||< 1 day (Acute)|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
2708779|NCT01182428|Secondary|Clinical Procedure Success|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.|Intra-operative|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
2708780|NCT01182428|Secondary|Clinical Device Success|Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.|Intra-operative|Based on Intent to Treat (ITT) population.|||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
2708781|NCT01182428|Primary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).|This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
2708782|NCT01182415|Secondary|Response Rate|The number of participants that achieved complete remission following high dose chemotherapy and autologous stem cell transplantation (ASCT). Complete remission is defined as the disappearance of all evidence of disease.|3 years|The participant that was lost to follow-up was not available for analysis.|||Participants|||Count of Participants
2708783|NCT01182415|Secondary|2-year Overall Survival (OS)|The percentage of participants alive after two years|2 years|The participant that was lost to follow-up was not available for analysis.|||percentage of participants||95% Confidence Interval|Number
2708784|NCT01182415|Secondary|2-year Progression Free Survival (PFS)|The percentage of participants alive and without disease progression at 2 years.|2 years|The participant that was lost to follow-up was not available for analysis.|||percentage of participants||95% Confidence Interval|Number
2708785|NCT01182415|Primary|Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year|The proportion of patients with central nervous system (CNS) involvement by B-cell Non-Hodgkin's Lymphoma (NHL), relapsed primary central nervous system lymphoma (PCNSL), or relapsed primary intraocular lymphoma (PIOL) who are alive and progression-free at one year|3 years|The participant that was lost to follow-up was not available for analysis.|||Participants|||Count of Participants
2708786|NCT01182376|Primary|LA Fibrosis|The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.|baseline, 1 year|The number of participants analyzed for both groups is less than the number enrolled due to patient attrition or poor MRI scans.|||percentage of fibrosis||Standard Deviation|Mean
2708787|NCT01182350|Post-Hoc|9-month Overall Survival (OS) Rate by Molecular Cohort|9-month OS rate is the percentage of participants alive at 9 months from registration.|9 months|The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy.|||percentage of participants||90% Confidence Interval|Number
2708814|NCT01182194|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||pg*h/mL||Standard Deviation|Mean
2708788|NCT01182350|Secondary|Median Progression Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time [months (m)] from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. For intrinsic pontine brainstem gliomas, only one lesion/mass is present at diagnosis. Comparisons of maximal 2-dimensional measurements, TxW (product of the longest diameter [width (W)] and its longest perpendicular diameter [transverse (T)]) are used to assess response for this target lesion. PD is 25% or more increase, taking as reference the smallest product observed since the start of treatment, or the appearance of one or more new lesions.|Disease assessments using a standard CNS imaging protocol occurred chemoradiation cycles 1 and 2, every other maintenance cycle, every 3 months post-treatment year 1 then annually until PD or therapy change; In this study cohort, follow-up was up to 34m.|"The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy. The PFS was aggregated across cohorts per statistical analysis plan to evaluate the effect of the molecular strategy."|||months||Full Range|Median
2708789|NCT01182350|Secondary|Number of Participants With Grade 3-4 Treatment-Related Toxicity Over Chemoradiation Therapy|Counts any participant experiencing at least one treatment-related grade 3 or 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) over chemoradiation therapy as reported on case report forms.|Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort.|The analysis population is comprised of the subset of participants who underwent surgical biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy.|||Participants|||Count of Participants
2708790|NCT01182350|Secondary|Feasibility Rate of Molecular Approach to Therapy|Feasibility rate of the molecular strategy is based on the percentage of participants either with inadequate tissue from surgical biopsy to confirm DIPG diagnosis and/or with uninterpretable results for identification of EGFR overexpression and MGMT methylation status.|3 weeks|The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.|||percentage of participants||90% Confidence Interval|Number
2708791|NCT01182350|Secondary|Delay in Radiation Therapy Start|The number of participants delaying the start of radiation therapy by more than 3 weeks due to complications as a result of surgical biopsy to obtain diagnostic tumor sample.|3 weeks|The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.|||Participants|||Count of Participants
2708792|NCT01182350|Secondary|Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate|Grade 3-4 post-procedural surgery-related toxicity rate is the percentage of participants experiencing at least one grade 3-4 adverse event (AE) during the post-procedural time frame of 14 days attributable to the surgical procedure based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4).|2 weeks|The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.|||percentage of participants||90% Confidence Interval|Number
2708793|NCT01182350|Secondary|Rate of Lethal Complications From Surgery|The rate of lethal complications from surgery is the percentage of participants dying as a result of surgery.|2 weeks||||percentage of participants||90% Confidence Interval|Number
2708794|NCT01182350|Primary|9-month Overall Survival (OS) Rate|9-month overall survival is the percentage of participants remaining alive 9 months from registration.|9 months|The analysis population is comprised of the subset of participants who underwent biopsy, obtained a molecularly-based treatment assignment and started assigned chemoradiation therapy.|||percentage of participants||90% Confidence Interval|Number
2708795|NCT01182337|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|"FAS Population~Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36."|||units on a scale||Standard Deviation|Mean
2708796|NCT01182337|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 months|"FAS Population~Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36."|||units on a scale||Standard Deviation|Mean
2708797|NCT01182337|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
2708798|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
2708799|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
2708800|NCT01182337|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 month|FAS Population|||units on a scale||Standard Deviation|Mean
2708801|NCT01182337|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~For the Neurological Assessment at 12 months, only 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects total)."|||participants|||Number
2708802|NCT01182298|Primary|Median Log Change in HCV RNA Levels on Day 7|The primary end point of this study is the the log change in HCV RNA levels on Day 7|first 7 days||||log IU/mL||Inter-Quartile Range|Median
2708803|NCT01182285|Secondary|NIS (Na/I-symporter) Expression|NIS (Na/I-symporter) Expression is assessed by quantitative reverse transcription (RT) polymerase chain reaction (PCR) and immunohistochemistry (IHC). NIS mRNA expression was measured by quantitative RT PCR from biopsy samples.|Entry to study and after 10 weeks of treatment|There is no standard of error to report. The acronym GAPDH expanded is glyceraldehyde 3-phosphate dehydrogenase. Only 1 participant was analyzed because biopsies were not performed in 12 subjects.|||percent expression||Standard Error|Median
2708804|NCT01182285|Secondary|Best Overall Response|Best overall response was assessed by radioiodine uptake. Complete response (CR) is increased Rai (radioiodine) uptake on post- valproic acid therapy at week 10, AND a decrease in Tg (thyroglobulin ) level to less than 2 ng/ml (or a decrease in Tg-Ab (thyroglobulin antibodies) level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Week 16|Best overall response was not assessed for the phase 1 portion.|||Participants|||Count of Participants
2708805|NCT01182285|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 41 months and 11 days|Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study.|||Participants|||Count of Participants
2708806|NCT01182285|Primary|RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment|Complete response (CR) is increased Rai uptake on post- valproic acid therapy at week 10, AND a decrease in Tg level to less than 2 ng/ml (or a decrease in Tg-Ab level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2.|13 participants were enrolled in phase 1 and 8/13 (5 from University of California San Francisco (UCSF) moved on from phase 1 to the phase 2 schedule 2 portion. However, Tg data from UCSF is unavailable for 5 of the participant, thus only 3 were analyzed in the phase 2 portion.|||Participants|||Count of Participants
2708807|NCT01182207|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708808|NCT01182207|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708809|NCT01182207|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708810|NCT01182207|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2708811|NCT01182207|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2708812|NCT01182207|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2708813|NCT01182194|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||pg*h/mL||Standard Deviation|Mean
2709010|NCT01181011|Primary|The Maximum Observed Plasma Concentration (Cmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for Cmax of Telmisartan|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2708815|NCT01182194|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||pg/mL||Standard Deviation|Mean
2708816|NCT01182194|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||ng*h/mL||Standard Deviation|Mean
2708817|NCT01182194|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||ng*h/mL||Standard Deviation|Mean
2708818|NCT01182194|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||ng/mL||Standard Deviation|Mean
2708819|NCT01182181|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2708820|NCT01182181|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2708821|NCT01182103|Secondary|BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls|"Serum BDNF levels were measured. MDD patients received antidepressant treatment, a standard biological management. Nothing novel (such as experimental drugs or management) is introduced in the treatment, so the research design is observational (of standard treatment).~The choice of antidepressant drugs depended on the need of patients in natural treatment procedure. They included selective serotonin reuptake inhibitors (SSRI), eg. fluoxetine or paroxetine."|2 years||||ng/ml||Standard Deviation|Mean
2708822|NCT01182103|Primary|Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls|"Chromatin immunoprecipitation (ChIP) was used to measure histone modification. The unit of our given machine is relative quantification, and a higher value indicated increased histone modification. The detailed method could be found in:~Huebert DJ, Kamal M, O'Donovan A, Bernstein BE: Genome-wide analysis of histone modifications by ChIP-on-chip. Methods 2006; 40: 365-369."|2 years||||relative quantification||Standard Deviation|Mean
2708823|NCT01182103|Primary|Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls|averaged percentage of methylation at each CpG site listed|2 years|Only 39 out of the 48 MDD patients provided enough blood sample for this analysis.|||percent||Standard Deviation|Mean
2708824|NCT01181986|Secondary|Plasma Glucose|Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6, and 8 hours post-study drug on day 11||||mg/dl||Standard Error|Least Squares Mean
2708825|NCT01181986|Secondary|Plasma Triglycerides|Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6 and 8 hours post-study drug on day 11||||mg/dl||Standard Error|Least Squares Mean
2708826|NCT01181986|Primary|Reactive Hyperemia Index (RHI)|Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.|0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)||||ratio||Standard Error|Least Squares Mean
2708827|NCT01181947|Primary|Technical Success at Time of Initial Implant|Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system|intraoperatively|"The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."|||participants||95% Confidence Interval|Number
2708828|NCT01181947|Secondary|ACM and ARM|All-cause (ACM), Aneurysm related (ARM) and dissection related mortality|at 30 days, 12 months, 24 months and 36 months|||||||
2708829|NCT01181947|Secondary|SAE|Serious Adverse Events (SAE)|through 12 months|"The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."|||participants||95% Confidence Interval|Number
2708830|NCT01181947|Primary|Treatment Success|"technical success and freedom from~TAA diameter increase of stented segment (>5mm compared to 1 mo),~Types I/III endoleak,~Aneurysm rupture,~Conversion to open surgery,~Stent graft occlusion,~Stent graft migration resulting in SAE or secondary intervention."|at 30 days, 12 months, 24 months and 36 months|||||||
2708831|NCT01181921|Primary|Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks|Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.|Baseline and 12 weeks|Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.||||||
2708832|NCT01181895|Secondary|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12|At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.|Week 4 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.|||Participants|||Number
2708833|NCT01181895|Secondary|Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)|The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.|Day 1 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.|||Participants|||Number
2708834|NCT01181895|Secondary|Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters per minute (L/min)||Standard Error|Least Squares Mean
2708835|NCT01181895|Secondary|Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters per minute (L/min)||Standard Error|Least Squares Mean
2708836|NCT01181895|Secondary|Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
2708837|NCT01181895|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2708838|NCT01181895|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2708839|NCT01181895|Primary|Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2708840|NCT01181804|Primary|t1/2 Boceprevir in Fasted State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||hours||Standard Deviation|Mean
2708841|NCT01181804|Primary|Half Life (t1/2) of Boceprevir in Fed State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||hours||Standard Deviation|Mean
2708842|NCT01181804|Primary|AUCinf in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2708843|NCT01181804|Primary|AUC From Hour 0 to Infinity (AUCinf) in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2708844|NCT01181804|Primary|Cmax of Boceprevir Tablets Versus Capsules in Fasted State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng/mL||90% Confidence Interval|Geometric Mean
2708845|NCT01181804|Primary|AUCtf for Boceprevir Tablets Versus Capsules in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2708846|NCT01181804|Primary|Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2708847|NCT01181804|Primary|Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2708848|NCT01181778|Secondary|Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method|Participant contacts with physician offices were collected, and the number of callbacks by method of contraception recorded. Participants who called back more than once were counted overall and for each method of contraception.|Up to four months after the counseling visit|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.|||percentage of participants|||Number
2708849|NCT01181778|Primary|Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling|Before receiving counseling, participants recorded on a questionnaire the method of contraception they thought they would choose. This was to be compared with the method of contraception the same participants thought they would choose after they received physician counseling, which was also recorded on their questionnaire.|Day of inclusion (Day 0) prior to physician counseling and after physician counseling|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.|||Participants|||Number
2708850|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708851|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708852|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708853|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708854|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708855|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708856|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708857|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708858|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708860|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708861|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708862|NCT01181726|Secondary|AUC0-inf of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708863|NCT01181726|Secondary|AUC0-t of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708864|NCT01181726|Secondary|Cmax of Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708865|NCT01181726|Primary|AUC0-inf of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708866|NCT01181726|Primary|AUC0-t of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2708867|NCT01181726|Primary|Cmax of Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2708868|NCT01181726|Primary|AUC0-inf of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2708869|NCT01181726|Primary|AUC0-t of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2708870|NCT01181726|Primary|Cmax of Norethindrone (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2708871|NCT01181609|Secondary|OS - Time to Event|OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.|Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)|ITT population|||months||95% Confidence Interval|Median
2708872|NCT01181609|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|Overall survival was defined as the time from start of study treatment to death from any cause.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population|||percentage of participants|||Number
2708873|NCT01181609|Secondary|Duration of Overall Disease Control|ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.|Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)|ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.|||months||95% Confidence Interval|Median
2708874|NCT01181609|Secondary|Duration of Response|Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.|Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)|ITT population; only participants with a response (CR or PR) were included in the analysis.|||months||95% Confidence Interval|Median
2708875|NCT01181609|Secondary|PFS - Time to Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population|||months||95% Confidence Interval|Median
2708876|NCT01181609|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT|||percentage of participants|||Number
2708877|NCT01181609|Secondary|Percentage of Participants Achieving a Best Overall Response of CR or PR|Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population|||percentage of participants||95% Confidence Interval|Number
2708878|NCT01181609|Primary|Percentage of Participants Achieving Overall Disease Control (ODC)|ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)|ITT population|||percentage of participants||95% Confidence Interval|Number
2708879|NCT01181596|Primary|Vessel Penetration of NICU-Tech RM9L-RS Probe|The algorithmic depth of vessel penetration will be collected.|1 day (day of procedure)|Images were not adequate to visualize catheter penetration, or to obtain measurements.||||||
2708880|NCT01181596|Primary|Participants That Fulfilled All Study Procedures.|Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.|1 day (day of procedure)|Study participants who have one or more catheters in place.|||Participants|||Count of Participants
2708881|NCT01181531|Secondary|Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|week 40-52||||Participants|||Number
2708882|NCT01181531|Secondary|Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)|Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Baseline to week 40-52||||Participants|||Number
2708883|NCT01181531|Primary|Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52|Baseline to week 40-52|All subjects randomized by treatment arm.|||Percent change||Standard Error|Least Squares Mean
2708884|NCT01181492|Secondary|PCA Fentanyl Consumption|PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.|24 h after surgery||||μg||Standard Deviation|Mean
2708885|NCT01181492|Secondary|The Visual Analog Scale 24 Hours Postoperative|The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation|24 hours after operation||||units on a scale||Standard Deviation|Mean
2708886|NCT01181492|Primary|CYP3A4*1G Polymorphism|According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G|48 hours after operation|the number of participants for analysis was determined according to gene type of CYP3A4*1G polymorphism which was carried by participant.|||participants|||Number
2708887|NCT01181479|Other Pre-specified|Self-reported Itching at Patch Application Site|"Evaluation of itching at patch application site was determined using the following scores:~0: None~Mild~Moderate~Severe"|1 year|Safety Population|||Score on a scale||Standard Deviation|Mean
2708888|NCT01181479|Other Pre-specified|Patch Adhesion by Investigator Evaluation at Each Visit|"Evaluation of patch adhesion was determined using the following scores:~0: >= 90% adhered (no lift)~>= 75% adhered but < 90% (some edges showing lift)~>= 50% adhered but < 75% (half of system lifts off)~< 50% (> half of system lifts off, but undetached)~patch completely detached"|1 year|Safety Population|||Score on a scale||Standard Deviation|Mean
2708889|NCT01181479|Other Pre-specified|Self-reported Irritation at Application Site|"Evaluation of irritation at application site was determined using the following scores:~0: None~Mild~Moderate~Severe"|1 year|Safety Population|||Score on scale||Standard Deviation|Mean
2708890|NCT01181479|Other Pre-specified|Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)|Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.|Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months|Subjects that received contraceptive and were analyzed for LNG and EE.|||pg/ml||95% Confidence Interval|Mean
2708891|NCT01181479|Other Pre-specified|Cycle Control|Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.|6 months|Number of subjects with documented cycle information.|||percentage of cycles with BTB/BTS|||Number
2708892|NCT01181479|Primary|Pregnancy|Pregnancy outcomes was determine by measuring Pearl index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year|Subjects in the Safety population, age 17-35 with a BMI <32, were analyzed.|||Pearl Index||95% Confidence Interval|Number
2708893|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events||From end of surgery through hospital discharge, an expected average of 6 days|FAS population includes all treated participants|||participants|||Number
2708894|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents|Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.|From end of surgery through PACU arrival, an expected average of 10 minutes|FAS population includes all treated participants|||participants|||Number
2708895|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane|Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included|||participants|||Number
2709011|NCT01181011|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Telmisartan|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2708896|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents|Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included|||participants|||Number
2708897|NCT01181349|Primary|Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival|The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).|Upon arrival in the PACU|Full analysis set (FAS) population includes all treated participants|||participants|||Number
2708898|NCT01181323|Secondary|ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects|Blood was collected from maternal subjects on Day 0 prior to vaccination, and at Day 28 post vaccination for assessment of IgA and IgG antibodies with a standard ELISA assay. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons' vaccines, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and Day 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.|||units/mL||95% Confidence Interval|Geometric Mean
2708899|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination.|Breast milk was collected from all maternal participants prior at Days 2 and 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 and 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708900|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 8 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 8 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.|||participants|||Number
2708901|NCT01181323|Secondary|Number of Maternal and Infant Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 2 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal and infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 2 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.|||participants|||Number
2708902|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 0 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 0 prior to vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.|||participants|||Number
2708903|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708904|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708905|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all infant participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708906|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708907|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
2708908|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of nasal congestion, runny nose, cough, sore throat, nasal bleeding, pain at injection site, tenderness at injection site, and swelling at injection site for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
2708909|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, weakness, and chills for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
2708910|NCT01181323|Primary|Number of Maternal Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
2708911|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708912|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
2708913|NCT01181323|Secondary|Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection for the assay was a titer of 10, sera samples below detection were given a value of 5 for analysis.|Day 0 and 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.|||titer||95% Confidence Interval|Geometric Mean
2708914|NCT01181323|Primary|Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination|Maternal participants were contacted by telephone at Day 42 to report all medically attended respiratory or gastrointestinal adverse events occurring in the infant participants between 28 and 42 days after maternal vaccination.|Within 28-42 days after maternal vaccination|All infant participants for whom the maternal participants were contacted are included in the analysis population description. One maternal participant was not contacted.|||participants|||Number
2708915|NCT01181323|Primary|Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains|Breast milk was collected at Day 0 prior to vaccination and again at 28 days following vaccination for testing in IgA and IgG ELISA Assays. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and 28 post vaccination|All enrolled maternal participants are included in this analysis population.|||units/mL||95% Confidence Interval|Geometric Mean
2708934|NCT01181258|Secondary|Serious Adverse Events|Number of participants experiencing serious adverse events that occur during study. Adverse event collection for the purposes of this study will focus on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL2 injections.|Day 1 through Month 12|One participant developed sepsis prior to receiving the NK cell infusion and was withdrawn from the study.|||Participants|||Count of Participants
2708916|NCT01181323|Primary|Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination|Adverse events (AE) for this protocol used the International Conference on Harmonization (ICH) guideline E6 definition of AE, any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product. Related was defined as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. Non-serious AEs were those that did not meet the definition of serious (see Outcome Measure 1). Maternal participants were queried at each visit through 28 days after vaccination for the occurrence of any AE for her or the infant separately from the pre-defined solicited symptoms.|Day 0 to Day 28 post vaccination|All enrolled participants are included in the analysis population for this outcome measure|||participants|||Number
2708917|NCT01181323|Primary|Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination|Maternal participants maintained a memory aid to record daily the occurrence in their infants of systemic adverse events of fever (defined as rectal temperature 37.8 degrees Celsius or greater), drowsiness, irritability/fussiness, loss of appetite, nasal congestion, difficulty breathing, runny nose, and cough for 11 days (Day 0-10) after maternal vaccination based on protocol-defined grading (none, mild, moderate or severe) for each symptom. Rectal temperature was measured once daily. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 11 days.|Day 0 to Day 10 post vaccination||||participants|||Number
2708918|NCT01181323|Primary|Number of Participants Reporting New Onset Chronic Medical Conditions|New onset chronic medical condition was defined as any new ICD-10 diagnosis for a participant that was expected to continue for at least 6 months and require continued health care intervention. ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th revision. Maternal participants were asked at each visit through 180 days after enrollment if they or their infants had any new diagnosis.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.|||participants|||Number
2708919|NCT01181323|Primary|Number of Participants Reporting Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.|||participants|||Number
2708920|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant||two years|Participants who ONLY underwent Autologous transplant, did not proceed to Allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
2708921|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant||Two Years|Participants who ONLY underwent Autologous transplant (did not proceed to Allogeneic)|||percentage of participants||90% Confidence Interval|Number
2708922|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for All Participants||2 years||||percentage of participants||90% Confidence Interval|Number
2708923|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for All Participants||2 years||||percentage of participants||90% Confidence Interval|Number
2708924|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants||Two-years after Allogeneic Transplant||||percentage of participants||90% Confidence Interval|Number
2708925|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants||2 years after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
2708926|NCT01181271|Secondary|Cumulative Incidence of Disease Relapse||2-years after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
2708927|NCT01181271|Secondary|Cumulative Incidence of Non-relapse Mortality|Non-relapse mortality is defined as participants who die from causes other than their underlying disease relapse, such as infection or graft versus host disease|2-years after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
2708928|NCT01181271|Secondary|Cumulative Incidence of Extensive Chronic Graft-versus-host-disease|Extensive chronic graft versus-host-disease (GVHD) was defined as GVHD that required systemic immunosuppression.|1-year after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
2708929|NCT01181271|Secondary|Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD)|Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.|within 200 days after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
2708930|NCT01181271|Secondary|Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL||within 28 days after allogeneic transplant|This was only measured in the 17 participants who experienced a hematological nadir after allo transplant.|||days||Full Range|Median
2708931|NCT01181271|Primary|Peripheral Blood All-cell Donor Chimerism|Successful donor stem cell engraftment is defined as when ≥ 80% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood at day 100 after non-myeloablative allogeneic stem cell transplantation.|100 days post allogeneic transplant|Participants who underwent the full tandem AUTO-ALLO stem cell transplant|||percentage of donor-derived elements||Full Range|Median
2708932|NCT01181258|Secondary|Patients With Expansion of NK Cells|Number of patients who experience in vivo expansion of allogeneic donor natural killer (NK) cells.|Day 14|Two participants were not evaluable. One patient died prior to receiving NK cell infusion and one did not survive by day 14; therefore 14 patients were analyzed for this outcome measure.|||Participants|||Count of Participants
2708933|NCT01181258|Secondary|Time to Disease Progression|Cumulative incidence will be used to determine time to disease progression.|Day 1 through Month 12|10 participants had disease progression|||days||Full Range|Median
2708935|NCT01181258|Primary|Number of Patients With an Objective Response|The number of patients with a partial response (PR) or complete response (CR). For patients with non-hodgkin's lymphoma: CR - complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR - at least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. For patients with chronic lymphocytic leukemia: CR - disappearance of all palpable disease, normalization of the blood counts without transfusions, bone marrow aspirate lymphocyte percentage < 30%, and no evidence of disease on bone marrow biopsy. PR - 50% or more reduction in palpable disease as well as one or more of the remaining features: neutrophils >= 1.5 × 109/L or 50% improvement over baseline, platelets more than 100 × 109/L or 50% improvement over baseline, and hemoglobin more than 11.0 g/dL or 50% improvement over baseline without transfusions.|Month 2 Post Infusion|Two participants were not evaluable. One patient died prior to receiving NK cell infusion and one did not survive by day 14; therefore 14 patients were analyzed for this outcome measure.|||Participants|||Count of Participants
2708936|NCT01181167|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding||2 weeks|Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or who had no safety data after the start of study treatment.|||percentage of subjects with bleeds||95% Confidence Interval|Number
2708937|NCT01181167|Primary|Incidence of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.|||percentage of subjects with vte events||95% Confidence Interval|Number
2708938|NCT01181141|Secondary|Proportion of Subjects With Venous Thromboembolism Events.||2 weeks|||||||
2708939|NCT01181141|Primary|The Incidence of Major or Clinically Relevant Non-major Bleeding|Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.|2 weeks|Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.|||percentage of subjects with bleeds||95% Confidence Interval|Number
2708940|NCT01181128|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||surgeries|Major Surgeries||Number
2708941|NCT01181128|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc, underwent major surgery, and had blood loss during surgery information available.|||mL|Major Surgeries|Full Range|Median
2708942|NCT01181128|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||IU/kg|Major Surgeries|Full Range|Median
2708943|NCT01181128|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes, including from the loading dose to the end date/time of surgery.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||injections|Major Surgeries|Full Range|Median
2708944|NCT01181128|Secondary|Investigators'/Surgeons' Assessment of Participants' Response to rFVIIIFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||responses|Major Surgeries||Number
2708945|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 14 and Week 28 in Haemo-QoL III Total Score|The Haemo-QoL III, a quality of life assessment instrument for adolescents with hemophilia, was administered to participants from 13 to 16 years old. This instrument assesses domains specific to living with hemophilia and consists of 12 domains: physical health, feeling, view of yourself, family, friends, others, sports and school, treatment, perceived support, dealing with hemophilia, future, and relationships. Total HAEMO-QoL score is the sum of all raw scores for all subscales for participants for whom at least the minimum number of required questions have been answered. Total scores are presented as the Transformed Scale Score (TSS) from 0-100%, with lower scores indicating a better quality of life. A negative change indicates improvement.|Baseline, Week 14, Week 28|Full Analysis Set: participants 13 to 16 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
2708977|NCT01181128|Primary|Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. ULN=upper limit of normal.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc n=the number of participants with at least one post-baseline value.|||participants|||Number
2709336|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2708946|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 28|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 28|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
2708947|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 14|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 14|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
2708948|NCT01181128|Secondary|Incremental Recovery (Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2708949|NCT01181128|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
2708950|NCT01181128|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2708951|NCT01181128|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
2708994|NCT01181011|Secondary|Number of Participants With at Least One Treatment Emergent Adverse Event||4 weeks|Treated set|||Participants|||Number
2708995|NCT01181011|Secondary|V_z/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Amlodipine|||L||Standard Deviation|Mean
2708996|NCT01181011|Secondary|CL/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Amlodipine|||L/h||Standard Deviation|Mean
2708997|NCT01181011|Secondary|t_½ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Amlodipine|||h||Standard Deviation|Mean
2708952|NCT01181128|Secondary|Area Under the Curve (AUC) Per Dose (Two-stage Chromogenic Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2708953|NCT01181128|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which the maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
2708954|NCT01181128|Secondary|Time at Maximum Activity (Tmax; One-stage Clotting Assay)|Time at which maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
2708955|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (Two-stage Chromogenic Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||days||95% Confidence Interval|Geometric Mean
2708956|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (One-stage Clotting Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||days||95% Confidence Interval|Geometric Mean
2708957|NCT01181128|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/kg||95% Confidence Interval|Geometric Mean
2708998|NCT01181011|Secondary|MRT_po of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Amlodipine|||h||Standard Deviation|Mean
2708999|NCT01181011|Secondary|λz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Amlodipine|||1/h||Standard Deviation|Mean
2709000|NCT01181011|Secondary|Tmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Amlodipine|||h||Standard Deviation|Mean
2708958|NCT01181128|Secondary|Volume at Steady State (Vss; One-stage Clotting Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/kg||95% Confidence Interval|Geometric Mean
2708959|NCT01181128|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.|||IU/kg||Inter-Quartile Range|Median
2708960|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had evaluable efficacy assessments; n=total number of bleeds at given location.|||injections||Inter-Quartile Range|Median
2708961|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
2708962|NCT01181128|Secondary|Number of Days From Last Treatment Injection to a New Bleeding Episode|"Number of days from the last injection to treat a bleeding episode to a new bleeding episode, analyzed for per evaluable bleeding episode and per participant. For per participant values, number of days from last injection to treat a bleed to a new bleeding episode is averaged across all evaluable bleeding episodes for each participant first, and then descriptive statistics were calculated across participants. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (not evaluable). The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period."|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode. The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time.|||days|Evaluable Bleeding Episodes|Inter-Quartile Range|Median
2708963|NCT01181128|Secondary|Annualized Joint Bleeding Rate (Spontaneous and Traumatic)|Annualized bleeding episodes = (Number of bleeding episodes of the specified type / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
2709001|NCT01181011|Secondary|Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Telmisartan|||L||Standard Deviation|Mean
2726935|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 100||||percentage of donor cells||Standard Deviation|Mean
2708964|NCT01181128|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (Number of bleeding episodes at the specified location / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.|||episodes per participant per year||Inter-Quartile Range|Median
2708965|NCT01181128|Secondary|Investigator's Assessment of Participants' Bleeding Response to rFVIIIFc Injection|The investigator was given the opportunity to record an assessment of a participant's response to treatment, if the participant was treated in the hospital for a major bleed, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|This supplemental assessment was not summarized because of insufficient data.||||||
2708966|NCT01181128|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode; based on the number of injections with an evaluation.|||percentage of responses|Bleeding Episodes||Number
2708967|NCT01181128|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. Overall units (IU/kg) of annualized rFVIIIFc consumption = [Total rFVIIIFc IU/kg received during the efficacy period / number of days in efficacy period] x 365.25.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and >=6 months on study.|||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
2708968|NCT01181128|Secondary|Comparison of Annualized Bleeding Rates: Arm 2 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.|||episodes per participant per year||95% Confidence Interval|Number
2708969|NCT01181128|Primary|Incremental Recovery (One-stage Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2709002|NCT01181011|Secondary|Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Telmisartan|||L/h||Standard Deviation|Mean
2709003|NCT01181011|Secondary|Elimination Half-life (t_½) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Telmisartan|||h||Standard Deviation|Mean
2709004|NCT01181011|Secondary|Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Telmisartan|||h||Standard Deviation|Mean
2708970|NCT01181128|Primary|Mean Residence Time (MRT; One-stage Clotting Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
2708971|NCT01181128|Primary|Clearance (CL; One-stage Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2708972|NCT01181128|Primary|Elimination Half Life (t1/2; One-stage Clotting Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
2708973|NCT01181128|Primary|Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2708974|NCT01181128|Primary|Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 1 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.|||episodes per participant per year||95% Confidence Interval|Number
2708975|NCT01181128|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes during the efficacy period / number of days during the efficacy period)*365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.|||episodes per participant per year||Inter-Quartile Range|Median
2708976|NCT01181128|Primary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFVIIIFc dose. ↑ signifies increase and ↓ signifies decrease.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc and had a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, systolic blood pressure, and diastolic blood pressure.|||participants|||Number
2708978|NCT01181128|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of Advate or rFVIIIFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before the last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or any other medically important event. AEs emergent between the first Advate injection and first on-study rFVIIIFc injection (Sequential PK Subgroup) or during the surgical/rehabilitation period (Surgery Subgroup) are presented separately.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc. For Arm 1, AEs emergent between 1st on-study Advate dose and 1st rFVIIIFc dose are reported as treatment-emergent to Advate (1st column); AEs emergent after 1st rFVIIIFc injection are reported as treatment-emergent to rFVIIIFc (2nd column).|||participants|||Number
2708979|NCT01181128|Primary|Incidence Rate of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% confidence interval (CI) were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFVIIIFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFVIIIFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
2708980|NCT01181102|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment|||percentage of subjects with bleeds||95% Confidence Interval|Number
2708981|NCT01181102|Primary|Incidence of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment~Definite diagnosis of symptomatic Pulmonary Embolism (PE)~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)"|2 weeks|Efficacy Analysis population. 22 (7.4%) - DU-176b 41 (13.9%) - enoxaparin|||percent of participants with VTE events||95% Confidence Interval|Number
2708982|NCT01181076|Secondary|Number of Participants With Oral Mucositis Grade 3-4|Oral mucositis will be graded according to the World Health Organization Oral Toxicity Grading Scale, range 0-4 in scores, higher scores mean worse outcome.|Up to 3 months||||participants|||Number
2708983|NCT01181076|Secondary|Number of Participants With Pain, as Determined by EORTC QLQ C30|These scores (range 0-100) will be assessed with the EORTC QLQ C30 form. Higher scores means more pain.|3 months after transplantation||||Participants|||Count of Participants
2708984|NCT01181076|Secondary|Number of Participants With Hospital Stay||Up to 8 months||||Participants|||Count of Participants
2708985|NCT01181076|Secondary|Frequency of Acute Graft Versus Host Disease Grade 3-4||Up to 3 months||||Participants|||Count of Participants
2708986|NCT01181076|Secondary|Duration Between Stem Cell Transplantation and Day of Engraftment.|Engraftment was judged by the number of days to neutrophils ≥0.2 × 109/l.|Up to 1 months||||days||Full Range|Median
2708987|NCT01181076|Secondary|Number of Episodes With Fever|Fever episodes|Up to 8 months||||Fever episodes|||Number
2708988|NCT01181076|Secondary|Number of Underweight Participants|Nutritional status will be assessed with anthropometry, biomarkers and bioimpedance. Here the number of underweight participants is reported.|3 month after transplantation||||Participants|||Count of Participants
2708989|NCT01181076|Primary|Global Quality of Life Score|A score for measurement of global quality of life will be obtained from the European Organisation for Research and Treatment of Cancer, form EORTC QLQ-C30. The scores range from 0 to 100, higher scores mean better outcome.|3 month after transplantation||||units on a scale||Standard Deviation|Mean
2708990|NCT01181050|Secondary|Change in DAS28-CRP After 24 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.|Week 0, Week 24|Change in DAS28-CRP was calculated by using last observation carried forward method.|||scores||Standard Deviation|Mean
2708991|NCT01181050|Secondary|Change in DAS28-CRP After 6 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.|Week 0, Week 6|Change in DAS28-CRP was calculated by using last observation carried forward method.|||scores||Standard Deviation|Mean
2708992|NCT01181050|Primary|Change in DAS28-CRP After 12 Weeks of Treatment|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.|Week 0, Week 12|Change in DAS28-CRP was calculated by using last observation carried forward method.|||scores||Standard Deviation|Mean
2708993|NCT01181011|Secondary|Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities||4 weeks|Treated set|||Participants|||Number
2709012|NCT01181011|Primary|Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Telmisartan|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2709013|NCT01180998|Primary|Distance Visual Acuity (VA)|Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 4 weeks of toric contact lens wear|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.|||logMAR|eyes|Standard Error|Least Squares Mean
2709014|NCT01180998|Primary|Distance Visual Acuity|Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 1 week of toric contact lens wear|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.|||logMAR|eyes|Standard Error|Least Squares Mean
2709015|NCT01180998|Primary|Overall Success in Fitting With a Toric Contact Lens|Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.|4 weeks|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.|||percentage of participants||95% Confidence Interval|Number
2709016|NCT01180985|Secondary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||CLUE score||Standard Deviation|Mean
2709017|NCT01180985|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
2709018|NCT01180985|Primary|Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||CLUE score||Standard Error|Least Squares Mean
2709019|NCT01180985|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
2709020|NCT01180985|Primary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/-1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||CLUE score||Standard Error|Least Squares Mean
2709021|NCT01180985|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||participants|||Number
2709022|NCT01180985|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
2709023|NCT01180894|Secondary|The Number of Participants Who Died||28 Days||||participants|||Number
2709024|NCT01180894|Secondary|Infection|"The number of participants with at least one infection.~Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI)."|28 Days||||participants|||Number
2709025|NCT01180894|Secondary|Iron-deficient Erythropoeisis (IDE)|An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.|14 Days||||micro mol: mol heme||Full Range|Mean
2709026|NCT01180894|Primary|RBC Transfusion|The number of participants who underwent RBC transfusion.|42 Days||||participants|||Number
2709027|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|Change from baseline in log10 HCV RNA level by visit.|Week 12|Efficacy analysis was performed on the virology population , which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result|||log10 HCV RNA level||Standard Deviation|Mean
2709028|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|The mean change from baseline in log10 HCV RNA level by visit for the virology population|Week 4|Efficacy analysis was performed on the virology population, which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result|||log10 HCV RNA Level||Standard Deviation|Mean
2709029|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response ( Six Months Post Dosing) (SVR24)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, six months post dosing.|6 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR24.|||percentage of participants|||Number
2709030|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response 12 Weeks ( Three Months Post Dosing) (SVR12)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, at 12 weeks (three months) post dosing.|3 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR12.|||percentage of participants|||Number
2709031|NCT01180790|Secondary|Segment 1 and Segment 2: End of Treatment Response|The percentage of the Virology Population subjects that were reported as undetectable HCV RNA at the completion of treatment.|Week 48 (Segment 1); Week 24 (Segment 2)|Segment 2 analyzed the Per Protocol Population, which includes all randomized subjects who completed 12 weeks of ACH-014625 dosing and an additional 12 weeks of Peg/Ribavirin dosing.|||percentage of participants|||Number
2709032|NCT01180790|Secondary|Segment 2: RVR4 (Rapid Viral Response at 4 Weeks)|For Segment 2, the percentage of subjects in the virology population that achieved RVR4, defined as HCV RNA< or equal to LOQ at the Week 4 visit.|4 weeks|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 4 weeks of ACH-0141625 dosing.|||percentage of participants|||Number
2709033|NCT01180790|Secondary|Segment 1: Complete Early Virologic Response (cEVR)|For Segment 1, the percentage of subjects in the virology population that achieved cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|12 weeks|Analysis for Segment 1 was performed on the virology population (which is the same as the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.|||percentage of participants|||Number
2709034|NCT01180790|Primary|Segment 2: Complete Early Virologic Response (cEVR)|The primary efficacy endpoint for Segment 2 of the study was the percentage of subjects achieving cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|Week 12|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 12 weeks of ACH-0141625 dosing.|||percentage of participants|||Number
2709035|NCT01180790|Primary|Segment 2: Safety|Segment 2: Percentage of Subjects with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|12 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625. Subjects were analyzed according to the randomized treatment.|||percentage of participants|||Number
2709036|NCT01180790|Primary|Segment 1 : Rapid Viral Response at Week 4 (RVR4)|The primary efficacy endpoint for Segment 1 of the study was the percentage of subjects in each treatment group achieving RVR at Week 4 (HCV RNA< or equal to LOQ at the Week 4 visit).|4 weeks|Efficacy analysis was performed on the virology population (a subset of the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.|||percentage of participants|||Number
2709037|NCT01180790|Primary|Segment 1: Safety|Segment 1: Percentage of subjects with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|4 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625 or Placebo. Subjects were analyzed according to the randomized treatment.|||percentage of participants|||Number
2709038|NCT01180777|Secondary|Corneal Staining|Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.|After 6-9 days of lens wear|All subjects who successfully completed the study.|||eyes|eye||Number
2709039|NCT01180777|Secondary|Binocular Snellen Visual Acuity (VA)|Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.|10-15 minutes post lens fit|All subjects who successfully completed the study.|||participants|||Number
2709040|NCT01180777|Primary|Lens Fit Acceptance|Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.|10-15 minutes post lens fit|All subjects who successfully completed the study.|||eyes|Eyes||Number
2709041|NCT01180660|Secondary|24 Hour Total Opioid Consumption|24 hour total opioid consumption using IV morphine equivalents|24 hours post surgery||||miligrams||Inter-Quartile Range|Median
2709042|NCT01180660|Primary|Quality of Recovery 40 on the Day After Surgery|"Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.~The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery."|24 hours||||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
2709043|NCT01180647|Secondary|Adverse Events and Serious Adverse Events|AEs and SAEs per standard definitions will be measured by self-report.|Eight weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||participants|||Number
2709044|NCT01180647|Secondary|Accidental Drug Overdose|Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||participants|||Number
2709045|NCT01180647|Secondary|Injection Drug Use Post-release|This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.|Four weeks post-release||||percentage of participants by arm|||Number
2709046|NCT01180647|Secondary|Any Opioid Use Post-release|Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||percentage of participants|||Number
2709047|NCT01180647|Secondary|Participation in Community Drug Treatment Post-release|This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||percentage of participants|||Number
2709048|NCT01180647|Primary|Post-Release Opioid Relapse|Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.|Four weeks post-release|One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured.|||participants||95% Confidence Interval|Number
2709049|NCT01180478|Secondary|Recurrence Rate Related to Additional Treatment Following TURB.||Until 135 days|Only 61 of the patients in the total population in the NBI group, and 69 of the patients in the total population of the WL group received a Re-TURBT after initial TURBT (within 135 days). These numbers therefore differ and deviate from the Participant Flow module.|||participants|||Number
2709050|NCT01180478|Secondary|Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.|We looked at different perioperative complications in order to discover peri-operative morbidity after instrumental treatment. The following variables were analyzed: Bleeding, Fever, UTI, Bladder cramps, DVT, CVA/TIA, Lung embolism, Sepsis, Acute Abdomen, and Other perioperative complications.|peri-operative|The variables contain missing values, therefore the numbers in the below table differs from the overall numbers reported|||Participants|||Count of Participants
2709051|NCT01180478|Secondary|Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.|"Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.~Grade II Requiring pharmacological treatment with drugs other than those allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.~Grade III Requiring surgical, endoscopic or radiological intervention Grade III-a Intervention not under general anaesthesia Grade III-b Intervention under general anaesthesia~Grade IV Life-threatening complication (including CNS complications: brain haemorrhage, ischaemic stroke, subarachnoid bleeding, but excluding transient ischaemic attacks) requiring IC/ICU management Grade IV-a Single organ dysfunction (including dialysis) Grade IV-b Multi-organ dysfunction~Grade V Death of a patient"|30 days|"The Clavien grading of perioperative complications variable contains missings, therefore the valid percentages are presented in the outcome measure data table. The NBI group had 2 missing values, and the WL group had 3 missing values. Therfore, the overall number deviates from 484 and 481.~Below shown is a categorical variable with 8 categories"|||Participants|||Count of Participants
2709052|NCT01180478|Secondary|Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection||3 months after treatment||||Participants|||Count of Participants
2709053|NCT01180478|Primary|Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.|The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.|1 year after treatment||||Participants|||Count of Participants
2709054|NCT01180400|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709055|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709056|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709057|NCT01180400|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709058|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709059|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709060|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709061|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709062|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709063|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709064|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709065|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709253|NCT01178294|Secondary|PK Analysis- Volume of Distribution (Vd) at Steady State|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population|||U/percent activity||Standard Deviation|Mean
2709066|NCT01180400|Secondary|"Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of Very Much Improved or Much Improved From Randomization (Week 8) to End of Treatment (Week 16)"|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2709067|NCT01180400|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709068|NCT01180400|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709069|NCT01180400|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2709070|NCT01180400|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
2709071|NCT01180400|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2709072|NCT01180400|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2709073|NCT01180400|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2709256|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|29 subjects (ITT population) had responses available at 24 hours after initial infusion of OBI-1.|||participants with bleeds controlled|||Number
2709074|NCT01180400|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2709075|NCT01180296|Secondary|Secondary Outcomes|Serum progesterone levels|Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group||||pg/mL||Standard Deviation|Mean
2709076|NCT01180296|Primary|Rate of Recurrent Preterm Birth|Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.|Prior to 37 weeks' gestation||||participants|||Number
2709077|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a sleep visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater difficulty with sleep. The change in Fibromyalgia Impact Questionnaire sleep visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents sleep improvement (i.e. a better outcome), while a positive value represents sleep worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionnaire|||units on a scale||Standard Deviation|Mean
2709078|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a pain visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater pain. The change in Fibromyalgia Impact Questionnaire pain visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents pain improvement (i.e. a better outcome), while a positive value represents pain worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare|||units on a scale||Standard Deviation|Mean
2709079|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Overall Score|The Fibromyalgia Impact Questionnaire yields a score ranging from 0 to 100, with higher scores representing a greater impact or level of symptoms. The change in Fibromyalgia Impact Questionnaire is determined by subtracting scores at baseline from scores at end of treatment. Thus negative numbers represent symptom improvement (i.e. a better outcome) and positive numbers represent symptom worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare|||units on a scale||Standard Deviation|Mean
2709080|NCT01180244|Secondary|Change in Number of Positive Tender Points|"The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations. A tender point is considered positive if less than 4 kilograms per centimeter squared pressure is required to elicit a painful response. The change in number of positive tender points is determined by subtracting the number of positive tender points at baseline from the number of positive tender points at end of treatment. Thus, a negative number represents pain improvement (i.e. better outcome), whereas a positive number represents a worsening of pain (i.e. worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment||||Number of positive tender points||Standard Deviation|Mean
2709081|NCT01180244|Primary|Change in Tender Point Pain Threshold|"Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of less pain sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment||||units on a scale||Standard Deviation|Mean
2709082|NCT01180127|Secondary|VO2max|measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the exercise, food additive lacking flavanol group had unusable data for this outcome and thus are not included in these analyses.|||mL/(kg·min)||Standard Deviation|Mean
2709083|NCT01180127|Secondary|Modified Rey Auditory Verbal Learning Test|Participants are read a list of words over three learning trials and the subject is asked to free recall as many words as possible after each trial. These 3 trials are followed by 1 learning trial of a distracter list and then a short delayed free recall trial of the initial list. After approximately 60-minutes, subjects are asked to freely recall words from the initial list, then to recall words form the distracter list, and then complete a forced-choice recognition trial. A source memory trial is administered in which subjects are read each presented word and then asked to identify whether they were initially presented during the 3 learning trials or during the distracter trial. Measured as a retention score (ratio) for which the number of words recalled after the short delay is divided by the number of words recalled on the third learning trial.|Up to 12 weeks after exercise/dietary intervention exposure|There were 4 subjects (1 in exercise, dietary intervention; 2 in no exercise, dietary intervention, and 1 in exercise, food additive lacking flavanol) who did not have useable data and are thus not included in analyses.|||ratio||Standard Deviation|Mean
2709084|NCT01180127|Primary|ModBent (Modified Benton Visual Retention Test)|This is an object recognition task. Participants view a complex stimulus, then are asked to select which one of two objects was identical to the studied stimulus. After a series of these matching trials, during the subsequent recognition trials participants are shown serially individual complex objects and asked to indicate whether the object was identical to any of the target stimuli viewed during the matching trials. Their reaction time for correct responses, measured in milliseconds, is the unit of measurement.|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the no exercise, dietary intervention group had outlying (larger than 3 standard deviation from mean) ModBent values that were deleted and hence those groups have 7 and 10 subjects analyzed rather than 8 and 11 respectively.|||milliseconds||Standard Deviation|Mean
2709085|NCT01180127|Primary|CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)|In steady state conditions, CBV is an indirect measure of basal metabolism in the brain. CBV-fMRI is a technique that generates maps of basal metabolism across different brain regions|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, food additive lacking flavanol arm, and one subject in the wait list control food additive without flavanol arm had non useable data for this outcome which is why there are only 8 subjects analyzed in those two arms rather than 9.|||percent CBV in a brain region||Standard Deviation|Mean
2709086|NCT01180049|Secondary|Quantify the Potential Effect of TEMSR on AUC and Cmax|"Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.~AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration"|From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)|The analysis was done on ITT Population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Ratio||90% Confidence Interval|Mean
2709087|NCT01180049|Secondary|Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent bleeding related AEs included events: epistaxis and ecchymosis. AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.|From screening up to a maximum of 57.1 months|Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety.|||Percentage of participants|||Number
2709088|NCT01180049|Secondary|Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state. Treatment-emergent infection-related AEs included events: pneumonia, bronchitis, infection, herpes simplex, oral candidiasis and sepsis. Grading by NCI CTCAE Version 3.0.: Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; urgent intervention indicated; Grade 5= death.|From screening up to a maximum of 57.1 months|Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety.|||Percentage of participants|||Number
2709089|NCT01180049|Secondary|Investigator Assessed PFS|"PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.~PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.~PFS assessment was done using EMA guidelines for sensitivity analysis censoring.~Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment."|From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Months||80% Confidence Interval|Median
2709090|NCT01180049|Secondary|Investigator's Assessment ORR (ORR = CR + PR)|"ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.~Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR."|From randomization date until end of treatment (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Percentage of participants||80% Confidence Interval|Number
2709091|NCT01180049|Secondary|Independent Assessment - Objective Response Rate (ORR = CR + PR)|"ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.~Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR."|From randomization date until end of treatment (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Percentage of participants||80% Confidence Interval|Number
2709092|NCT01180049|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death due to any cause.|From randomization date until death due to any cause (average follow up done for 56.1 months)|"Analysis was done on ITT population. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Months||80% Confidence Interval|Median
2709093|NCT01180049|Primary|Independently Assessed Progression-free Survival (PFS)|"PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.~PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.~PFS assessment was done using EMA guidelines for sensitivity analysis censoring.~Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment."|From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Months||80% Confidence Interval|Median
2709094|NCT01180036|Secondary|Remission Status|The number of subjects to reach either complete remission or partial remission at 12 months after randomization.|12 months after randomization||||Participants|||Count of Participants
2709095|NCT01180036|Primary|Remission Status|The number of subjects to reach the composite of maintaining complete remission or partial remission at 24 months after randomization will be the primary endpoint.|24 months after randomization||||Participants|||Count of Participants
2709096|NCT01179984|Secondary|Primary Target Lesion Patency|Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure|12 months post-index procedure|Primary Target Lesion Patency (TLP) at 12 months post-index procedure.|||percentage of participants|||Number
2709097|NCT01179984|Primary|(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.|"Safety:~Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure."|30 day follow-up|Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.|||percentage of freedom from events|||Number
2709098|NCT01179984|Primary|Acute Effectiveness: Percentage of Stents With Successful Delivery|"Effectiveness:~Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length."|At implantation (Day 0)||||percentage of stents|Stents|95% Confidence Interval|Mean
2709099|NCT01179919|Secondary|Steady-State Cmax and Cmin of Oseltamivir Carboxylate|Cmax is the maximum concentration and Cmin in the minimum concentration of oseltamivir carboxylate measured in nanogram of oseltamivir carboxylate per milliliter of plasma (ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir|||ng/mL||Standard Deviation|Mean
2709100|NCT01179919|Primary|Steady-State AUC of Oseltamivir Carboxylate|AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour*ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir|||hour*ng/mL||Standard Deviation|Mean
2709101|NCT01179737|Secondary|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.|168 days|||||||
2709102|NCT01179737|Primary|Change in Pulmonary Vascular Resistance (PVR)|Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.|168 days|||||||
2709103|NCT01179737|Secondary|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized|Baseline, 168 days|||||||
2709104|NCT01179672|Secondary|Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score|SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing SDS Total Score at baseline and 12 weeks.|||units on a scale||Standard Error|Least Squares Mean
2709105|NCT01179672|Secondary|Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score|BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing BPI-Interference score at baseline and 12 weeks.|||units on a scale||Standard Error|Least Squares Mean
2709106|NCT01179672|Secondary|Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score|BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline BPI-Severity average pain scores.|||percentage of participants|||Number
2709107|NCT01179672|Secondary|Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain|24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline 24-hour average pain score.|||percentage of participants|||Number
2709108|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ|SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12 weeks SF-MPQ score based on the randomized group were analyzed; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2709109|NCT01179672|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint|PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|12 weeks|All participants with a baseline and 12-week PGI-I score.|||units on a scale||Standard Error|Least Squares Mean
2709110|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale|CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week CGI-S score based on the randomized group were analyzed. Data from 9 sites was not included in analysis due to wrong questionnaire used.|||units on a scale||Standard Error|Least Squares Mean
2709111|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale|BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week, 24-hour BPI-Severity score based on the randomized group were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2709112|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain|24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week 24-hour night pain score and worst pain score based on the randomized group were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2709113|NCT01179672|Primary|Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score|24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|Intent-to-treat (ITT) principle was applied: All participants with a baseline and 12-week 24-hour average pain score based on the randomized group were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2709337|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709114|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk20||Standard Deviation|Mean
2709115|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk12||Standard Deviation|Mean
2709116|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk20||Standard Deviation|Mean
2709117|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk12||Standard Deviation|Mean
2709118|NCT01179568|Primary|Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale|Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.|Weeks 12 and 20|Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .|||percentage of responders|||Number
2709119|NCT01179516|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2709120|NCT01179516|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
2709121|NCT01179516|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2709122|NCT01179516|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2709123|NCT01179516|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
2709124|NCT01179516|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2709125|NCT01179490|Secondary|Pharmacokinetic Parameters (t1/2)|Plasma pharmacokinetics (t1/2) of unchanged bendamustine|On Day 1 only||||h||Standard Deviation|Mean
2709126|NCT01179490|Secondary|Pharmacokinetic Parameters (AUC)|Plasma pharmacokinetics (AUC) of unchanged bendamustine|On Day 1 only||||ng・h/mL||Standard Deviation|Mean
2709127|NCT01179490|Secondary|Pharmacokinetic Parameters (Tmax)|Plasma pharmacokinetics (tmax) of unchanged bendamustine|On Day 1 only||||h||Standard Deviation|Mean
2709128|NCT01179490|Secondary|Pharmacokinetic Parameters (Cmax)|Plasma pharmacokinetics (Cmax) of unchanged bendamustine|On Day 1 only||||ng/mL||Standard Deviation|Mean
2709129|NCT01179490|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.|Up to 2 years||||Events|||Number
2709130|NCT01179490|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.~grade 1 : mild~grade 2 : moderate~grade 3 : severe or medically significant but not immediately life-threatening~grade 4 : life threatening or disabling~grade 5 : death related to AE"|Up to 2 years||||Participants|||Number
2709131|NCT01179490|Secondary|Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years||||Events|||Number
2709132|NCT01179490|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years||||Participants|||Number
2709133|NCT01179490|Secondary|Overall Survival (OS)|OS is the period from the date of patient registration to the date of death.|Up to 2 years||||Days||Full Range|Median
2709134|NCT01179490|Secondary|Duration of Response (DOR)|DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.|Up to 2 years||||Days||Full Range|Median
2709135|NCT01179490|Secondary|Time to Treatment Failure (TTF)|TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.|Up to 2 years||||Days||Full Range|Median
2709136|NCT01179490|Secondary|Progression-Free Survival (PFS)|"PFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death.~Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion."|Up to 2 years||||Days||Full Range|Median
2709137|NCT01179490|Secondary|Response Rate (Based on the Modified SWOG Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (SWOG) requires the followings:~Decline in myeloma protein of ≥25%-<74% in serum myeloma protein~Reduction in 24h urinary myeloma protein of ≥25%-<89%~No increase in skeletal destruction~Serum calcium within normal range"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
2709138|NCT01179490|Secondary|Response Rate (Based on the Bladé Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (Bladé) requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks.~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.~≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)."|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
2709139|NCT01179490|Secondary|CR Rate Based on the (Bladé) Criteria|"The proportion of subjects evaluated as CR was calculated.~CR (Bladé) requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)~Disappearance of soft tissue plasmacytomas"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
2709140|NCT01179490|Secondary|Response Rate (Based on the IMWG Criteria)|"The proportion of subjects evaluated as response [sCR + CR + very good partial response (VGPR) + Partial Response (PR)] was calculated.~VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h~PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to <200mg per 24 h"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
2709141|NCT01179490|Secondary|CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]|"The proportion of subjects evaluated as CR [strict CR (sCR) + CR] was calculated.~sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
2709142|NCT01179490|Primary|Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]|"The proportion of subjects evaluated as CR was calculated.~CR (modified SWOG) requires all of the followings:~Decline in serum myeloma protein by ≥75% to ≤25 g/L~Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h~No increase in skeletal destruction~Serum calcium within normal range~No blood transfusion required in the previous 3 months"|Up to 36 weeks||||Percentage of Participants||95% Confidence Interval|Number
2709143|NCT01179477|Primary|Left Ventricular Bipolar Pacing Capture Threshold|Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up|5 years|Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data.|||Volts||Standard Deviation|Mean
2709144|NCT01179477|Primary|Percent of Participants Alive and Without a Left Ventricular Lead-related Complication|Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).|5 years|The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects.|||Participants|||Count of Participants
2709145|NCT01179399|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960|Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)|up to 12 months|Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.||||||
2709146|NCT01179347|Secondary|Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score|Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.|Baseline and 12 weeks|FAS reduced to patients having CFQ-R information at baseline and at week 12.|||Units on a scale||Standard Deviation|Mean
2709147|NCT01179347|Secondary|Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment|Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.|12 weeks|FAS reduced to patients having RSSQ information on day 29, 57 or 85.|||Percentage of Participants|||Number
2709148|NCT01179347|Secondary|Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25−75) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25−75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
2709149|NCT01179347|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
2709150|NCT01179347|Secondary|Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
2709151|NCT01179347|Primary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
2709152|NCT01179347|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response|Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
2709153|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing HR describes an average within-subject increase in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min*h||Standard Deviation|Mean
2709154|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine HR describes an average within-subject change in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min*h||Standard Deviation|Mean
2709155|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
2709156|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
2709157|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
2709158|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under the effect curve (AUEC) at each visit of supine SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
2709159|NCT01179334|Secondary|Maximum Change From Baseline in Standing Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min||Standard Deviation|Mean
2709160|NCT01179334|Secondary|Maximum Change From Baseline in Supine Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min||Standard Deviation|Mean
2709161|NCT01179334|Secondary|Maximum Change From Baseline in Standing Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg||Standard Deviation|Mean
2709162|NCT01179334|Secondary|Maximum Change From Baseline in Supine Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg||Standard Deviation|Mean
2709163|NCT01179334|Secondary|Maximum Change From Baseline in Standing Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg||Standard Deviation|Mean
2709164|NCT01179334|Primary|Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|pharmacodynamic(s) (PD) analysis set|||mmHg||Standard Deviation|Mean
2709165|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (respiration). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.|||breaths/min||Standard Deviation|Mean
2709166|NCT01179217|Secondary|Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (temperature). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.|||degree C||Standard Deviation|Mean
2709167|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (pulse rate). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.|||bpm||Standard Deviation|Mean
2709168|NCT01179217|Secondary|The Effect of Oral L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (reticulocyte count), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.|||1000 cells/uL||Standard Deviation|Mean
2709169|NCT01179217|Secondary|The Effect of Oral L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (hematocrit), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.|||% of red blood cells||Standard Deviation|Mean
2709170|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (systolic and diastolic blood pressure). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, 24, and 48|Safety Population which includes all patients that took at least one dose of study medication.|||mm Hg||Standard Deviation|Mean
2709171|NCT01179217|Secondary|The Effect of Oral -L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (hemoglobin), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.|||g/dL||Standard Deviation|Mean
2709338|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709172|NCT01179217|Secondary|The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain|The number of emergency room visits or medical facility visits that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.|||Number of ER visits||Full Range|Median
2709173|NCT01179217|Secondary|The Number of Hospitalizations for Sickle Cell Pain|The number of hospitalizations that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.|||Number of hospitalizations||Full Range|Median
2709174|NCT01179217|Primary|The Number of Occurrences of Sickle Cell Crises|The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.|||Number of crises||Full Range|Median
2709175|NCT01179191|Other Pre-specified|Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
2709176|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Illicit Substances|Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
2709177|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2709178|NCT01179191|Other Pre-specified|Number of Participants With Abnormal Urine Drug Test Results|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
2709179|NCT01179191|Other Pre-specified|Number of Participants With Aberrant Behaviors|Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = 'never' and 4 = 'very often']. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.|Day 5|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.|||Participants|||Number
2709180|NCT01179191|Secondary|Investigator's Level of Satisfaction With the EMBEDA Conversion Guide|The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.|Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a Scale||Standard Deviation|Mean
2709181|NCT01179191|Secondary|Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)|BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale.|||Units on a scale||Standard Deviation|Mean
2709182|NCT01179191|Secondary|Percentage of Participants With Rescue Medications Usage During Titration|Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2709183|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.|||titration steps||Standard Deviation|Mean
2709184|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||titration steps||Standard Deviation|Mean
2709185|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.|||Days||Standard Deviation|Mean
2709186|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
2709187|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received.|||Percentage of participants||95% Confidence Interval|Number
2709188|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.|||Percentage of participants||95% Confidence Interval|Number
2709189|NCT01179113|Secondary|Postoperative Nausea and Vomiting|Number of participants that experienced Postoperative nausea and vomiting using at PACU|1 day||||participants|||Number
2709190|NCT01179113|Secondary|Opioid Consumption in PACU Obtained From the Recorded Data|Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).|1 day||||mg||Standard Deviation|Mean
2709191|NCT01179113|Primary|Post-operative Pain Using Verbal Rating Scale (VRS)|"Verbal Rating Scale goes from 0 to 10, where:~0 indicates= No pain and 10 indicates= The worst possible pain~The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay"|1 day||||Scores on a scale||Standard Deviation|Mean
2709192|NCT01179048|Secondary|Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.|Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects|||Percentage of subjects|||Number
2709193|NCT01179048|Secondary|Time From Randomisation to First Occurrence of a Composite Microvascular Outcome|"Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:~new onset of persistent macroalbuminuria~persistent doubling of serum creatinine~need for continuous renal replacement therapy~death due to renal disease~need for retinal photocoagulation or treatment with intravitreal agents~vitreous haemorrhage~diabetes-related blindness~The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented."|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.|||Percentage of subjects|||Number
2709383|NCT01178216|Secondary|Number of Adverse Events, Toxicity Assessments|Adverse effects in study participants|12 months||||events|||Number
2709194|NCT01179048|Secondary|Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome|Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All the randomised subjects.|||percentage of subjects|||Number
2709195|NCT01179048|Secondary|Time From Randomisation to All Cause Death|Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects|||percentage of subjects|||Number
2709196|NCT01179048|Secondary|Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.|Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.|||percentage of subjects|||Number
2709197|NCT01179048|Primary|Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)|Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.|||percentage of subjects|||Number
2709198|NCT01178944|Other Pre-specified|MicroRNA Expression - miR-215-5p|Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.|Baseline|All treated participants that had enough tissue to perform microdissection to collect epithelial cells for subsequent microRNA profiling.|||Arbitrary fluorescent intensity||95% Confidence Interval|Mean
2709199|NCT01178944|Other Pre-specified|Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes|Kaplan-Meier estimates of median survival time for each genotype|From the date of study enrollment up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2709200|NCT01178944|Secondary|Time to Progression (TTP)|Estimated using the Kaplan-Meier method and proportional hazards models.|From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2709201|NCT01178944|Secondary|Overall Survival (OS)|Estimated using the Kaplan-Meier method and proportional hazards models.|From the date of study enrollment to the time of death from any cause, assessed up to 5 years|All treated and eligible patients.|||months||95% Confidence Interval|Median
2709202|NCT01178944|Secondary|Number of Participants With an Adverse Event|Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 30 days after the last dose of study drug(s)|All treated and eligible patients|||participants|||Number
2709203|NCT01178944|Primary|Overall Response Rate|Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|All Cohort -1 treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2709204|NCT01178853|Primary|Percent Mean Change From Baseline of International Normalized Ratio (INR)|INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)|22 Days||||percent change||Standard Deviation|Mean
2709205|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10|Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
2709206|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10|Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
2709254|NCT01178294|Secondary|Pharmacokinetics (PK) Analysis- Plasma Clearance|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population (= all subjects in the ITT population who consent to PK draws and have factor VIII levels measured at the central reference laboratory)|||U/(percent activity*hours)||Standard Deviation|Mean
2709207|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10|Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
2709208|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10|Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
2709209|NCT01178827|Secondary|Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 2 Post-Dose|All patients who received of Oxybutynin IR|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
2709210|NCT01178827|Secondary|Plasma Levels of Sanctura XR® at Day 10 Post-dose|Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 10 Post-Dose|All patients who received of Sanctura XR®|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
2709211|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.|Day 2 Post-Dose|All patients who received Oxybutynin IR|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
2709212|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose|Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.|Day 10 Post-Dose|All patients who received Sanctura XR®|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
2709213|NCT01178762|Primary|Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments|We performed direct fluorescent antibody (DFA) tests for Chlamydia by swabbing across the lower and upper tarsal conjunctiva four times after topical application of 0.5% proparacaine. All of the DFA tests were examined by the same experienced microbiologist who was masked to the identities and clinical conditions of the patients. Each DFA slide was read under a fluorescent microscope and was observed for discrete fluorescent chlamydial elementary bodies (EBs).The DFA test was considered positive if above 10 EBs were counted per high-power field.|4 weeks, 8 weeks and 12 weeks after the first dose of the medication|Only participants with confirmed DFA tests are counted in the results below. Participants with confirmed negative DFA tests subsequently stopped treatment and were not retested. Participants lost to follow-up are counted as not having a confirmed DFA negative test|||participants|||Number
2709214|NCT01178671|Secondary|Sexual Functioning|as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).|up to 24 weeks|intent to treat|||units on a scale||Standard Deviation|Mean
2709215|NCT01178671|Secondary|Sleep Quality|as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).|up to 24 weeks|intent to treat|||units on a scale||Standard Deviation|Mean
2709216|NCT01178671|Secondary|Adverse Effects|as assessed by Side Effect Checklist|up to 24 weeks|intent to treat|||percentage of subject dropped due to AEs|||Number
2709217|NCT01178671|Secondary|Remission Status|Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint|up to 24 weeks|intent to treat|||percentage of subjects|||Number
2709218|NCT01178671|Secondary|Response Status|Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint|up to 24 weeks|intent to treat|||percentage of subjects|||Number
2709219|NCT01178671|Secondary|Depression Severity|as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|up to 24 weeks|intent to treat|||units on a scale||Standard Deviation|Mean
2709220|NCT01178671|Secondary|PTSD Self-rated Severity|as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).|up to 24 weeks|completers|||units on a scale||Standard Deviation|Mean
2709221|NCT01178671|Secondary|Alternative Measure of PTSD Severity|as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)|up to 24 weeks|completers|||units on a scale||Standard Deviation|Mean
2709222|NCT01178671|Primary|Time to Discontinuation of Study Treatment||up to 24 weeks||||days||Standard Deviation|Mean
2709223|NCT01178671|Primary|PTSD Severity|PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).|up to 24 weeks|intention to treat sample|||units on a scale||Standard Deviation|Mean
2709255|NCT01178294|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode||Through 90 days ± 7 days following final OBI-1 dose|Because of expected sparseness of positive anti-OBI-1 antibody titers, formal statistical analyses of correlation were not performed.||||||
2709224|NCT01178528|Secondary|New York Heart Association (NYHA) Class|"The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient's limitations in physical activities caused by cardiac symptoms.~Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD.~Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD.~Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD.~Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD.~Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation."|3 months||||participants|||Number
2709225|NCT01178528|Primary|Maximal Oxygen Consumption|Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.|3 months||||mL/Kg/min||Standard Deviation|Mean
2709226|NCT01178528|Secondary|Quality of Life|Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome.|3 months||||units on a scale||Standard Deviation|Mean
2709227|NCT01178528|Primary|Exercise Tolerance Assessed by 6 Minute Walking Test|"Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist.~Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible."|3 months||||meters||Standard Deviation|Mean
2709228|NCT01178385|Secondary|Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).|This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2709229|NCT01178385|Secondary|Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)|This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2709230|NCT01178385|Primary|Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)|This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2709231|NCT01178333|Secondary|Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn||From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
2709232|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge||From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
2709233|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.||||days||95% Confidence Interval|Median
2709234|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.||||days||Standard Error|Mean
2709235|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used in Hospital|Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
2709236|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint|Heparin PF-4 OD test results were the dichotomous outcome (<1.0 vs. >=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
2709237|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia|Heparin PF-4 optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Nadir Platelet Count (x10^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||X10^9 / L||Standard Deviation|Mean
2709238|NCT01178333|Secondary|Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis|Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|There was one missing data for optical density test results in Isolated HIT group. Therefore, 283 subjects were used for Isolated HIT group.|||participants|||Number
2709239|NCT01178333|Secondary|Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn||||participants|||Number
2709240|NCT01178333|Secondary|Type of Heparin Exposure - Unfractionated Heparin (UFH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn||||participants|||Number
2709241|NCT01178333|Secondary|Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT|"Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:~Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.~Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.~Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects."|From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn||||participants|||Number
2709242|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The median survival time is reported by each group for the time to occurrence of major bleeding.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||95% Confidence Interval|Median
2709243|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
2709244|NCT01178333|Secondary|Time to Occurrence of Radiographically Confirmed Thromboembolism|"The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
2709245|NCT01178333|Secondary|Time to Occurrence of Limb Amputation or Limb Gangrene|"Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
2709246|NCT01178333|Secondary|Time to Death|The median survival time is reported by each group for the time to death.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||95% Confidence Interval|Median
2709247|NCT01178333|Secondary|Time to Death|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
2709248|NCT01178294|Other Pre-specified|Anti-human Factor VIII Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|Anti-human factor VIII antibody titer data were presented in subject data listings. No statistical test was planned for anti-human factor VIII antibody titer.||||||
2709249|NCT01178294|Secondary|Number of Participants Who Developed an Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|21 subjects in the ITT population (n=29) with available baseline and follow-up test results|||participants|||Number
2709250|NCT01178294|Secondary|Number of Participants Who Developed de Novo Anti-OBI-1 Antibody Titers||Through 90 days ± 7 days following final OBI-1 dose|28 eligible subjects with acquired hemophilia A in the ITT population (n=29), of whom 18 had no detectable anti-porcine FVIII inhibitor titers at baseline (<0.6 BU) and 10 had detectable anti-porcine FVIII antibody titers at baseline (>=0.6 BU)|||participants|||Number
2709251|NCT01178294|Secondary|PK Analysis- Terminal Half-life|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. Half-life was calculated as the time it took to reduce percent activity by half.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population|||hours||Standard Deviation|Mean
2709252|NCT01178294|Secondary|PK Analysis- Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Measurable Concentration|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. AUC was calculated as area under the percent activity-time curve.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population|||percent activity*hours||Standard Deviation|Mean
2709257|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at 16 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|All 19 subjects in the ITT population (n=29) who had responses available at 16 hours after initial infusion of OBI-1 had a positive response.|||subjects with eventual bleed control|||Number
2709258|NCT01178294|Secondary|Correlation Between Positive Response to OBI-1 Therapy at 8 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|Of 21 subjects in the ITT population (n=29) with responses available at 8 hours after initial infusion of OBI-1, 20 had a positive response.|||subjects with eventual bleed control|||Number
2709259|NCT01178294|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.|||infusions per participant||Standard Deviation|Mean
2709260|NCT01178294|Secondary|Total Dose of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.|||dose in U/kg||Standard Deviation|Mean
2709261|NCT01178294|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes|'Frequency of infusions' was calculated as the 'average number of infusions per day'. 'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.|||average number of infusions per day||Standard Deviation|Mean
2709262|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|16 hours|19 subjects of the ITT population (n=29) had responses available at 16 hours after initial infusion of OBI-1.|||percentage of serious bleeding episodes|Responses Available at 16 hrs|95% Confidence Interval|Number
2709263|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|8 hours|21 subjects of the ITT population (n=29) had responses available at 8 hours after initial infusion of OBI-1.|||percentage of serious bleeding episodes|Responses Available at 8 hrs|95% Confidence Interval|Number
2709264|NCT01178294|Secondary|Overall Percentage of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator|Treatment success was defined as control of qualifying bleeding episode at the time of final treatment dosing. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|At the time of final treatment dosing (varied from participant to participant depending on bleeding episodes)|ITT population = 29 subjects with initial serious bleeding episodes (BEs)|||percentage of serious bleeding episodes|Initial Serious Bleeding Episodes|95% Confidence Interval|Number
2709265|NCT01178294|Primary|Percentage of Serious Bleeding Episodes Responsive to OBI-1|"The initial serious (qualifying) bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'."|24 hours after initiation of treatment|Intent to Treat (ITT) population = 29 subjects with initial serious bleeding episodes|||percentage of serious bleeding episodes|Initial Serious Bleeding Episodes|95% Confidence Interval|Number
2709266|NCT01178281|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score|The FACT-An is a 47-item, cancer-specific questionnaire consisting of a core 27-item general questionnaire measuring the four general domains of QoL (physical, social/family, emotional and functional well-being), and an additional 20-item anemia questionnaire (FACT-An Anemia subscale) that measures 13 fatigue-associated items (FACT-F Fatigue subscale) and seven non-fatigue-related items. Each item is scored using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). FACT-An total score is calculated by adding all the FACT-An subscales together. The total score ranges from 0-188 with higher scores representing better QOL.|Baseline and Days 85 and 169|Global study intent-to-treat population with available data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2709279|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709384|NCT01178216|Secondary|Number of Patients Reporting a Serious Infection|Infection rate in study participants|12 months||||Participants|||Count of Participants
2709267|NCT01178281|Secondary|Change From Baseline in EuroQoL-5D (EQ-5D) Visual Analog Scale|EQ-5D is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D includes 2 components: the EQ-5D health state profile (descriptive system) and the EQ-5D visual analog scale (VAS). On the VAS the participant rates his/her health state on a line from 0 (worst imaginable health) to 100 (best imaginable health).|Baseline and Days 85 and 169|Global study intent-to-treat population with available data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2709268|NCT01178281|Secondary|Change From Baseline in EuroQoL-5D (EQ-5D) Health Index Score|"EQ-5D is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D includes 2 components: the EQ-5D health state profile (descriptive system) and the EQ-5D visual analog scale (VAS). For the health state profile participants rate their perceived health state today on 5 dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression on a Likert-type scale from 1 to 3, where 1 = no problems, 2 = some problems, and 3 = extreme problems. The EQ-5D Health Utility Index (HUI) was generated from the five health state domain scores, and ranges from -0.594 (worst) and 1 (best) imaginable health state, with -0.594 representing an unconscious health state."|Baseline and Days 85 and 169|Global study intent-to-treat population with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2709269|NCT01178281|Secondary|Healthcare Resource Utilization||From first dose of study drug up to 28 days after last dose, as of the data cut-off date of 16 Jan 2013; median treatment duration was 23.6 weeks in the pomalidomide arm and 23.9 weeks in the placebo arm.|Analysis of healthcare resource utilization data were not collected during the study and no analysis were performed.||||||
2709270|NCT01178281|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|A TEAE is an adverse event (AE) that starts on or after the first dose of study drug. The severity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE),Version 4.0 and according to the following scale: Grade 1 = Mild (transient or mild discomfort; no limitation in activity; no medical intervention/therapy required); Grade 2 = Moderate (mild to moderate limitation in activity, some assistance may be needed; minimal medical intervention/therapy required); Grade 3 = Severe (marked limitation in activity, assistance usually required; medical intervention/therapy required, hospitalization possible); Grade 4 = Life-threatening (extreme limitation in activity, significant assistance or medical intervention/therapy required, hospitalization or hospice care probable); Grade 5 = Death Drug-related (related) AEs are those suspected by the Investigator as being related to administration of study drug|From the first dose of study drug until 28 days after last dose; median treatment duration was 23.7 weeks in the pomalidomide arm, 23.9 weeks in the placebo arm, and 24.0 weeks in the China extension pomalidomide arm.|Participants who received at least 1 dose of study drug|||Participants|||Count of Participants
2709271|NCT01178281|Secondary|Time to RBC-Transfusion Independence|Time to response was measured from first dose of study drug to the start of the first response. The start date of the response was defined as one day after the last date of an RBC-transfusion for participants who received a RBC-transfusion after the first dose, and as the date of the first dose of study drug for participants who received no RBC-transfusions during the 84 days after the first dose of study drug.|168 days|Global study intent-to-treat population with an 84-day RBC-transfusion independence response|||weeks||Full Range|Median
2709272|NCT01178281|Secondary|Duration of RBC-Transfusion Independence|The duration of RBC-transfusion independence is the time from the date at which the first RBC-transfusion independence started to the date of another RBC-transfusion given at least 84 days after the time the transfusion independence started. The duration of the RBC-transfusion independence was analyzed using the Kaplan-Meier method. Data were censored at the end of the treatment phase for participants who had not received another RBC-transfusion after the start of transfusion independence by the end of treatment phase.|From first dose of study drug up to 28 days after last dose, as of the data cut-off date of 16 Jan 2013; median treatment duration was 23.6 weeks in the pomalidomide arm and 23.9 weeks in the placebo arm.|Global study intent-to-treat population with an 84-day RBC-transfusion independence response|||months||95% Confidence Interval|Median
2709273|NCT01178281|Secondary|Overall Survival|The time from randomization to the death or to the latest date when participants are known to be alive. Overall survival was analyzed using Kaplan-Meier method; participants who were alive or lost to follow-up were censored at the latest date they were known to be alive.|From first dose of study drug up to end of study; median follow-up time was 19.1 months in the pomalidomide 0.5 mg arm and 17.6 months in the placebo arm.|Global study intent-to-treat population|||months||95% Confidence Interval|Median
2709274|NCT01178281|Primary|China Extension: Number of Participants Achieving a Hemoglobin Increase of ≥ 15 g/L Compared to Baseline for ≥ 84 Consecutive Days|A response in the China extension study was defined as an increase in hemoglobin ≥ 15 g/L above baseline value (in the absence of RBC transfusion) for ≥ 84 consecutive days.|From the first dose of study drug until treatment discontinuation; median treatment duration was 24.0 weeks.|China extension intent-to-treat population, which includes all participants enrolled in the China extension study.|||Participants|||Count of Participants
2709275|NCT01178281|Primary|Percentage of Participants Who Achieved RBC-Transfusion Independence|RBC-transfusion independence was defined as the absence of RBC transfusions for any consecutive 84-day interval.|168 days|Global study intent to treat population (ITT) which includes all participants randomized to either of the two study drugs, regardless of whether or not any study drug was actually taken.|||percentage of participants||95% Confidence Interval|Number
2709276|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709277|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709278|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709282|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709283|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709284|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709285|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709286|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease|The composite of ST, all death, and all MI rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709287|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.|The composite of ST, all death, and all MI rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709288|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Vessel Treated Subgroup|ID-TVF rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709289|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Vessel Treated Subgroup|ID-TVF rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709290|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Lesion Treated Subgroup|ID-TVF rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709291|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Lesion Treated Subgroup|ID-TVF rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709292|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients Without Diabetic Disease|ID-TVF rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709293|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients With Diabetic Disease|ID-TVF rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709294|NCT01178268|Secondary|Acute Gain||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
2709295|NCT01178268|Secondary|Percent Diameter Stenosis (%DS)||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.|||Percent Diameter stenosis|Participants|Standard Deviation|Mean
2709296|NCT01178268|Secondary|Percent Diameter Stenosis||pre procedure|The number of participants with angiographic follow up available was analysed.|||percent Diameter stenosis|Participants|Standard Deviation|Mean
2709297|NCT01178268|Secondary|Follow-up In-segment Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|Participants||Number
2709298|NCT01178268|Secondary|Follow-up In-segment Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percent Diameter stenosis|Participants|Standard Deviation|Mean
2709299|NCT01178268|Secondary|Follow-up In-segment Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
2709300|NCT01178268|Secondary|Follow-up In-stent Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|Participants||Number
2709301|NCT01178268|Secondary|Follow-up In-stent Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percent Diameter stenosis|Participants|Standard Deviation|Mean
2709302|NCT01178268|Secondary|Follow-up In-stent Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
2709303|NCT01178268|Secondary|Follow-up Late Loss|This is one of the Secondary Angiographic Endpoint.|≥13 months.|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
2709304|NCT01178268|Secondary|XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire|A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.|During the procedure||||percentage of participants|||Number
2709305|NCT01178268|Secondary|Fluoroscopy Time|This is the procedure related endpoint.|On day 0, during the procedure.||||Minutes||Standard Deviation|Median
2709306|NCT01178268|Secondary|Amount of Contrast Used|Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.||||Milliliter||Standard Deviation|Median
2709308|NCT01178268|Secondary|Acute Procedure Success|Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non-Q-wave), or repeat revascularization of the target lesion during the hospital stay.|< or = 1 day||||percentage of participants|||Number
2709309|NCT01178268|Secondary|Acute Device Success|Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.|< or = 1 day||||percentage of participants|Participants||Number
2709310|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709311|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709312|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709313|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709314|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709315|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Overall (0 - 772 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709316|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Very late (366 - 772 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709317|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Late (31 - 365 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709318|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Early (0 - 30 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709319|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Subacute (1 - 30 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709320|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Acute (<1 day)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709321|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709322|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709339|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709340|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709341|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)|One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709342|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709343|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||9 Months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709344|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||6 Months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709345|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||30 Days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709346|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709347|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709348|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709349|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709350|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709351|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709352|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709353|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709354|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709355|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709356|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709357|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709358|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709359|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709360|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709361|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709362|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709363|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709364|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709365|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709366|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709367|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709368|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709369|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709370|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709371|NCT01178268|Secondary|Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|The is the major Secondary Efficacy Endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants||95% Confidence Interval|Number
2709372|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709373|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709374|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709375|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709376|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709377|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709378|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709379|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non- Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
2709380|NCT01178268|Primary|Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)|The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants||95% Confidence Interval|Number
2709381|NCT01178268|Primary|Ischemia-driven Target Vessel Failure (ID-TVF)|This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants||95% Confidence Interval|Number
2709382|NCT01178268|Primary|In-stent Late Loss (LL)|"This is the primary angiographic endpoint.~In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)"|>=13 months|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
2709385|NCT01178216|Secondary|Number of Acute Rejection Episodes|Number of rejection episodes in study participants|12 months|32 patients were successfully transplanted during the study, of 39 total participants. Only those who were transplanted were assessed for this endpoint.|||rejection episodes|||Number
2709386|NCT01178216|Secondary|Reduction in Anti-HLA Antibodies|Number of patients with a reduction in anti-HLA antibodies.|9 months|Donor specific antibodies (DSAs) assessed in transplanted population with DSA at time of transplant (32/39 patients transplanted during study, 23/32 with DSA at time of transplant)|||percentage of patients|||Number
2709387|NCT01178216|Secondary|Number of Patients With Allograft Survival|Graft survival in study participants|12 months|32 patients were successfully transplanted during the study, of 39 total participants.|||Participants|||Count of Participants
2709388|NCT01178216|Primary|Number of Patients That Underwent Transplantation|This trial is designed to determine if Rituximab + IVIG can improve rates of transplantation for highly-HLA sensitized DD candidates on the UNOS waiting list over a 9M period of time after completion of treatment.|9 month||||Participants|||Count of Participants
2709389|NCT01178138|Primary|Blood Pressure Effects of Prazosin on Methamphetamine|"Blood pressure effects of prazosin on methamphetamine;~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The blood pressure was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the blood pressure was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine||||mmHg||Standard Deviation|Mean
2709390|NCT01178138|Primary|Heart Effects of Prazosin on Methamphetamine|"Heart effects of prazosin on methamphetamine;~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The heart rate was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the heart rate was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine||||beats per minute||Standard Deviation|Mean
2709391|NCT01178138|Primary|Self-report Effects of High.|"Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales.~Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect).~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine||||units on a scale||Standard Deviation|Mean
2709392|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|"Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.|||percentage of pregnancies|||Number
2709393|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|"Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.|||percentage of pregnancies|||Number
2709394|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|"Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.|||percentage of pregnancies|||Number
2709395|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule|"Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.|||percentage of pregnancies|||Number
2709396|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule|"Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.|||percentage of pregnancies|||Number
2709397|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule|"Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.|||percentage of pregnancies|||Number
2709398|NCT01178125|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.|||pregnancies / cumulative exposure||95% Confidence Interval|Number
2709399|NCT01178125|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
2709400|NCT01178125|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
2709401|NCT01178125|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.|||pregnancies / cumulative exposure||95% Confidence Interval|Number
2709402|NCT01178125|Other Pre-specified|Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint|A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.|Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)|Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.|||participants|||Number
2709403|NCT01178125|Other Pre-specified|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.|Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.|Safety population (received at least 1 dose of DR-102)|||participants|||Number
2709404|NCT01178125|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered on drug if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets."|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
2709405|NCT01178099|Secondary|P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12|"PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula:~([PRU at baseline - PRU at time of post baseline] / PRU at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
2709406|NCT01178099|Secondary|Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12|Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
2709407|NCT01178099|Secondary|Change From Baseline in the Area Under the Aggregation Curve at Day 12|AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||aggregation units*minutes (AU*min)||Standard Deviation|Mean
2709408|NCT01178099|Secondary|Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12|PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percentage PRI||Standard Deviation|Mean
2709409|NCT01178099|Secondary|Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
2709410|NCT01178099|Secondary|Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251|Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
2709411|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:~([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
2709421|NCT01178086|Secondary|Percentage of Participants With B-Symptoms|B-symptoms included fever, night sweats, weight loss.|Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)|Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.|||percentage of participants|||Number
2709412|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
2709413|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
2709414|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:~([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
2709415|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
2709416|NCT01178099|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251|AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
2709417|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
2709418|NCT01178099|Primary|Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727|Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
2709419|NCT01178099|Primary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727|The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Time of dosing up to 8 hours post-dose on Day 1 and Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
2709420|NCT01178086|Secondary|Percentage of Participants With Best Overall Response (BOR)|Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin>/=11 grams/deciliter(g/dL), lymphocytes<4000 cells/cubic millimeter(cells/mm^3), neutrophils>5000 cells/mm^3,platelets>100,000 cells/mm^3,bone marrow biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or >/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: >/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or >/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD.|From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)|Analysis was performed on EAS.|||percentage of participants|||Number
2709422|NCT01178086|Secondary|Percentage of Participants With General Symptoms|General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion.|Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)|Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.|||percentage of participants|||Number
2709423|NCT01178086|Secondary|Percentage of Participants With Karnofsky Performance Status Index|Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours.|Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)|Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.|||percentage of participants|||Number
2709424|NCT01178086|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours.|Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)|Analysis was performed on EAS. Here, number analyzed=participants evaluable at specified time-point.|||percentage of participants|||Number
2709425|NCT01178086|Secondary|Mean Body Weight||Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)|Analysis was performed on EAS. Overall number of participants analyzed=participants analyzed for this outcome. Here, number analyzed=participants evaluable at specified time-point.|||kilograms (kg)||Standard Deviation|Mean
2709426|NCT01178086|Secondary|Percentage of Participants Who Received Each Treatment During the Course of Study|The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono.|Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)|Analysis was performed on EAS.|||percentage of participants|||Number
2709427|NCT01178086|Secondary|Percentage of Participants With Progression and Death|Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes.|From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)|Analysis was performed on EAS with events.|||percentage of participants|||Number
2709428|NCT01178086|Primary|Percentage of Participants Without Progression or Death|Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes.|From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)|Analysis was performed on EAS.|||percentage of participants||95% Confidence Interval|Number
2709429|NCT01178086|Primary|Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate|PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.|From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)|Analysis was performed on EAS.|||months||95% Confidence Interval|Median
2709430|NCT01178073|Secondary|Change From Baseline in Borg Dyspnea Index at Week 24|Borg Dyspnea Index (BDI) indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI was calculated by using the Borg category (C) ratio (R) CR10 scale which starts at 0 (nothing at all) and has no upper limit (extremely strong). Change from BL was calculated as the Week 24 values minus the BL value. The BDI scale was assessed by each participant. The BL BDI score is the average of the two BDI values obtained following the two 6MWD tests used in determining the BL 6MWD. A negative change from BL in the BDI score represented an improvement for the participant. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline (BL) and Week 24|mITT Population. Only participants with Baseline data were analyzed.|||Scores on a scale||Inter-Quartile Range|Median
2709439|NCT01177956|Secondary|Duration of Response Until Cut-off Date 25 January 2011|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|Subgroup of participants from the study population having best confirmed response (CR or PR).|||months||95% Confidence Interval|Median
2709701|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
2709431|NCT01178073|Secondary|Change From Baseline in the World Health Organization Functional Class at Week 24|The WHO Functional Class (FC) indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Baseline WHO FC is the latest assessment prior to dosing (i.e., at Randomization or Screening). Change from Baseline at Week 24 was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observations was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.|||Scores on a scale||Inter-Quartile Range|Median
2709432|NCT01178073|Secondary|Change From Baseline in the 6 Minute Walk Distance Test at Week 24|The 6-minute walk distance (6MWD) test measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned a rank reflecting the relative order of the actual event times. Baseline 6MWD comprised of an average of the last two consecutive measurements prior to randomization that varied by no greater than 10%. If only one measurement was available, that measurement was used. If no two consecutive measures vary by no greater than 10% then Baseline was based on the last two consecutive measures for a participant.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.|||Meters||95% Confidence Interval|Median
2709433|NCT01178073|Secondary|Percentage of Participants With a Satisfactory Clinical Response at Week 24|A satisfactory clinical response at Week 24 is defined as a participant who meets all of the following criteria: 10% improvement in 6MWD compared with Baseline; improvement to or maintenance of World Health Organization (WHO) class I or II symptoms; no events of clinical worsening prior to or at the Week 24 visit. Clinical worsening events included: death, hospitalization for pulmonary arterial hypertension (PAH), and disease progression. Participants without an event of clinical worsening prior to or at the Week 24 visit who did not have a 6MWD value or a WHO functional class value at Week 24 were excluded from the analysis.|Baseline and Week 24|"mITT Population. Only those participants who had a Yes/No response were analyzed."|||Percentage of participants|||Number
2709434|NCT01178073|Secondary|Percent Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate marker of heart failure. The data were log-transformed. The geometric mean was calculated (based on the log-transformed data). The geometric mean ratio was calculated as the ratio between the Week 24 value and the Baseline value (based on the log-transformed data) and presented as percent change = 100 * (geometric mean ratio - 1). The Baseline value is the last value prior to administration of study drug; this may be prior to or on the day of study drug initiation. No imputation was performed for missing data. The secondary endpoints were analyzed according to a pre-specified hierarchical testing procedure.|Baseline and Week 24|mITT Population. Only participants with data available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
2709435|NCT01178073|Primary|Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV|Time to the first adjudicated CF event (death, hospitalization for worsening pulmonary arterial hypertension [PAH], disease progression, or unsatisfactory long-term clinical response) after initiating either first-line combination therapy with AMB and TAD or first-line monotherapy with either drug (AMB or TAD) in par. with PAH was assessed. If data was not available for some par. following a loss to follow-up, their event times were treated as censored at their last assessment time for the statistical analyses. FAV occurred approximately 4 weeks after the predicted 105th adjudicated first CF event was reached. Par. who had an FAV, and who had no adjudicated events or whose first adjudicated event occurred after their FAV, were censored at their individual FAV. Modified Intent-to-Treat (mITT) Population: all randomized par. who met the PAH diagnosis and inclusion/exclusion criteria defined in protocol amendment 2 and who also received at least one dose of investigational product (IP).|From Baseline up to the Final Assessment Visit (FAV) (average of 609 days)|mITT Population|||Participants|||Number
2709436|NCT01177969|Secondary|Anxiety Disorders Interview Schedule: Child and Parent Versions|The Anxiety Disorders Interview Schedule: Child and Parent Versions are clinician-rated scales assessing anxiety symptoms and the associated severity and impairment in children over the past month. The clinician interviewer interviews the child and parent separately about the nature and severity of the child's anxiety. If a child meets criteria for an anxiety disorder, a single item is rated by the interviewer, which represents anxiety severity. The scale score for this single item ranges from 0 to 8 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which was an average of 16 weeks after Baseline||||units on a scale||Standard Deviation|Mean
2709437|NCT01177969|Primary|Pediatric Anxiety Rating Scale.|The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which is an average of 16 weeks after Baseline||||units on a scale||Standard Deviation|Mean
2709438|NCT01177956|Secondary|Duration of Response Until Cut-off Date 15 November 2012|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|Subgroup of participants from the study population having best confirmed response (CR or PR).|||months||95% Confidence Interval|Median
2709514|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.|Week 12|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
2709440|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 15 November 2012|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
2709441|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 15 November 2012|BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or chemotherapy.|||percentage of participants||95% Confidence Interval|Number
2709442|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 25 January 2011|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
2709443|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
2709444|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
2709445|NCT01177956|Secondary|Overall Survival (OS) Time Until Cut-off Date 15 November 2012|The OS time was defined as the time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
2709446|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 25 January 2011|BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||percentage of participants||95% Confidence Interval|Number
2709447|NCT01177943|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]|The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had an AUC value were included in the AUC analysis.|||nanogram hour per milliliter (ng*h/mL)||90% Confidence Interval|Least Squares Mean
2709448|NCT01177943|Primary|Maximum Observed Plasma Concentration (Cmax)|The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had a Cmax value were included in the Cmax analysis.|||nanogram per millileter (ng/mL)||90% Confidence Interval|Least Squares Mean
2709449|NCT01177813|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|"Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.~Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category."|From first drug intake until 7 days after last medication intake, up to 219 days|Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set|||percentage of participants|||Number
2709498|NCT01177137|Secondary|Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores.|Change in Tinnitus Functional Index emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater emotional distress.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709450|NCT01177813|Secondary|Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)|"The term baseline refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.~For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored."|Baseline and week 24|FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule|||mmHg||Standard Error|Mean
2709451|NCT01177813|Secondary|Change From Baseline to Week 24 in Body Weight|"The term baseline refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS (LOCF) and open-label set (LOCF)|||kg||Standard Error|Mean
2709452|NCT01177813|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks|"The term baseline refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets|||percent of HbA1c||Standard Error|Mean
2709453|NCT01177800|Other Pre-specified|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability|The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent's genetic input) anomaly.|Baseline up to end of study (Week 26)|Safety Population included all participants randomly assigned to infliximab or placebo group.|||participants|||Number
2709454|NCT01177800|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26|The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 26|ITT population included all participants randomly assigned to Infliximab or placebo group. 'n' included those participants who were evaluable for this measure at specific time points.|||units on a scale||Standard Deviation|Mean
2709455|NCT01177800|Secondary|Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10|The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported.|Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group.|||percentage of participants|||Number
2709456|NCT01177800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group. Here 'n' included those participants who were evaluable for this measure at specific time points.|||units on a scale||Standard Deviation|Mean
2709457|NCT01177800|Primary|Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)|The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.|Week 10|Intent to treat (ITT) population included all participants randomly assigned to Infliximab or placebo group.|||percentage of participants|||Number
2709458|NCT01177735|Primary|Progression-free Survival (PFS) After Initiation of Pomalidomide Therapy|Progression -free survival (PFS) after initiation of pomalidomide therapy. Progressive disease is defined as increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL); Urine M-component and/or (the absolute increase must be > 200 mg/24 h); Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; the absolute percentage must be > 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|1 year following initiation of pomalidomide therapy||||percentage of participants|||Number
2709459|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post each vaccination|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).|||Participants|||Number
2709460|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 after each dose|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).|||Participants|||Number
2709461|NCT01177722|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).|Day 0 (pre-vaccination) and 30 days post-dose 3|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2709462|NCT01177722|Primary|Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).|30 Days post-dose 3|Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).|||Participants|||Number
2709463|NCT01177722|Primary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™|Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.|Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2709464|NCT01177709|Secondary|Insulin Level|fasting serum insulin uIU/ml.|baseline, 4 weks, 8 weeks, 12 weeks||||uIU/ml||Standard Error|Mean
2709465|NCT01177709|Secondary|Glucose Levels|Fasting glucose|baseline, 4 weeks, 8 weeks, 12 weeks||||mg/dL||Standard Error|Mean
2709466|NCT01177709|Primary|Weight (wt) in Pounds (Lbs)..|Patients weight in pounds|baseline, 4 weeks, 8 weeks, 12 weeks||||weight(wt) in pounds(lbs)||Standard Error|Mean
2709467|NCT01177670|Secondary|Safety Endpoints|The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.|At one and two years|Intent to treat|||participants|||Number
2709468|NCT01177670|Primary|Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.|The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.|At one and two years|Efficacy results were not tabulated due to the early termination of the study. Only 169 of the planned 1,000 subjects (16.9%) were enrolled therefore the study is defined as incomplete, as fewer than one-third of the intended patients were enrolled.||||||
2709469|NCT01177553|Secondary|Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.||6 months|||||||
2709470|NCT01177553|Primary|Survival|Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.|6 months||||percentage of AGA babies who survived|||Number
2709471|NCT01177410|Primary|The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.|||participants|||Number
2709499|NCT01177137|Secondary|Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores.|Change in Tinnitus Functional Index relaxation interference sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater relaxation interference.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709472|NCT01177410|Secondary|Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.|||participants|||Number
2709473|NCT01177384|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 Weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.|||Participants|||Number
2709474|NCT01177384|Primary|Number of Participants Who Experienced at Least One Adverse Event||Up to Week 24 + 14 Day Post-Study Follow-up|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.|||Participants|||Number
2709475|NCT01177384|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach).|||mg/dL||95% Confidence Interval|Least Squares Mean
2709476|NCT01177384|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).|||Percent||95% Confidence Interval|Least Squares Mean
2709477|NCT01177293|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2709478|NCT01177293|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2709479|NCT01177293|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Full Range|Geometric Mean
2709480|NCT01177293|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
2709481|NCT01177293|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
2709482|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"|||percent inhibition*days||Standard Deviation|Mean
2709483|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"|||percent inhibition*days||Standard Deviation|Mean
2709484|NCT01177228|Primary|Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding.~Emax was calculated on Day 1, Day 85, and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"|||percent inhibition||Standard Deviation|Mean
2709485|NCT01177228|Primary|Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding.~Emax was calculated on Day 1, Day 85 and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"Pharmacodynamic (PD) Analysis Set, defined as all participants for whom there were sufficient data to estimate PD. Analyses only include participants with available data (indicated by n)."|||percent inhibition||Standard Deviation|Mean
2709486|NCT01177228|Primary|Terminal Phase Elimination Half-life (t½) of Vedolizumab|Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose through Day 253|PK Analysis Set; participants with available data|||days||Standard Deviation|Mean
2709487|NCT01177228|Primary|Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab|"AUC was calculated for 3 time intervals during the study:~AUC (Day 0-14): from administration on Day 0 to last quantifiable concentration on Day 14, selected to capture the AUC following the first dose of vedolizumab until administration of the second dose~AUC(Day 85-99): from administration on Day 85 to last quantifiable concentration on Day 99, selected to assess the amount of drug accumulation with the planned loading regimen by comparing it to AUC(Day 0-14)~AUC(Day 85-141): from the first quantifiable concentration on Day 85 to the last quantifiable concentration on Day 141, selected to assess the drug exposure over an 8-week period"|Days 0-14, Days 85-99, Days 85-141|PK Analysis Set; participants with available data at each time point (indicated by “n”).|||day*μg/mL||Standard Deviation|Mean
2709488|NCT01177228|Primary|Cmin: Minimum Observed Plasma Concentration of Vedolizumab|Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|PK Analysis Set; participants with available data.|||μg/mL||Standard Deviation|Mean
2709489|NCT01177228|Primary|Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|"Pharmacokinetic (PK) Analysis Set, defined as all vedolizumab participants for whom there were sufficient data to estimate PK. Analyses only include participants with available data at each time point (indicated by n)."|||µg/mL||Standard Deviation|Mean
2709490|NCT01177228|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.~The intensity for each AE was defined according to the following criteria:~Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities."|From the first date of study drug administration through Day 253|Safety Analysis Set, defined as all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population.|||participants|||Number
2709491|NCT01177189|Secondary|Vascular Function Following the Antioxidant Intervention|The degree of vasodilation following the antioxidant intervention measured by Doppler ultrasound.|8 weeks||||percentage of vasodilation||Standard Error|Mean
2709492|NCT01177189|Secondary|Exercise-induced Oxidative Stress (i.e. Free Radical Concentrations and Levels of Lipid Peroxidation)|"Free radicals and levels of lipid peroxidation were measured using electron paramagnetic spectroscopy and ELISA assays.~A minimum value is 0 and a maximum value is 10. A higher value is a worse outcome."|8 weeks||||units on a scale||Standard Error|Mean
2709493|NCT01177189|Primary|Vascular Function (i.e. % Flow Mediated Vasodilation)|The effect on flow mediated vasodilation is measured using Doppler ultrasound.|8 weeks||||percentage of vasodilation||Standard Error|Mean
2709494|NCT01177137|Secondary|Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores.|Change in Tinnitus Handicap Inventory catastrophic sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 20 with higher scores representing greater catastrophic effect of the tinnitus.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709495|NCT01177137|Secondary|Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores.|Change in Tinnitus Handicap Inventory emotional sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 36 with higher scores representing greater emotional distress.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709496|NCT01177137|Secondary|Change in Tinnitus Handicap Inventory Functional Sub-scale Scores.|Change in Tinnitus Handicap Inventory functional sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 44 with higher scores representing greater functional difficulties.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709497|NCT01177137|Secondary|Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores.|Change in Tinnitus Functional Index reduced quality of life sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater reduction in quality of life.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709702|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
2709500|NCT01177137|Secondary|Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores.|Change in Tinnitus Functional Index auditory difficulties sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater auditory difficulties.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709501|NCT01177137|Secondary|Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores.|Change in Tinnitus Functional Index sleep disturbance sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater sleep disturbance.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709502|NCT01177137|Secondary|Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores.|Change in Tinnitus Functional Index cognitive interference sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater cognitive interference.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709503|NCT01177137|Secondary|Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores.|Change in Tinnitus Functional Index reduced sense of control sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater reduction of control.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709504|NCT01177137|Secondary|Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores.|Change in Tinnitus Functional Index intrusiveness sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater intrusiveness of the tinnitus.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709505|NCT01177137|Secondary|Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores.|Change in Tinnitus Questionnaire somatic complaint sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 8 with higher scores representing greater somatic complaints.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709506|NCT01177137|Secondary|Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores.|Change in Tinnitus Questionnaire sleep disturbance sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 8 with higher scores representing greater sleep disturbance.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709507|NCT01177137|Secondary|Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores.|Change in Tinnitus Questionnaire auditory perceptual sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 14 with higher scores representing greater auditory difficulties.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including all data from participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709508|NCT01177137|Secondary|Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores.|Change in Tinnitus Questionnaire intrusiveness sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 14 with higher scores representing greater intrusiveness of the tinnitus.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709509|NCT01177137|Secondary|Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months.|Change in Tinnitus Questionnaire emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 38 with higher scores representing greater emotional distress.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709510|NCT01177137|Secondary|Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up|"10 point visual analog scale asking How much of a problem is tinnitus? on a scale from 0 no problem at all to 10 as much as you can imagine"|Baseline to 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709511|NCT01177137|Secondary|Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up|Change in THI score from baseline to 3 months follow-up. The THI is a tinnitus-specific health-related quality of life instrument. Subscales include the functional (scored 0 to 44), emotional (scored 0 to 36) and catastrophic (scored 0 to 20). The total score ranges from 0 to 100 with higher scores indicating a greater impact of tinnitus on quality of life.|Baseline and 3. 6. 12. and 18 months|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709512|NCT01177137|Secondary|Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months|The TFI is a tinnitus-specific health -related quality of life instrument. Subscales include intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties (related to tinnitus), relaxation interference, reduced quality of life, and emotional distress. The total and each subscale score ranges from 0 to 100 with higher scores indicated a greater impact of tinnitus on quality of life.|Baseline and 3, 6, 12, and 18 months|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2709513|NCT01177137|Primary|Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months|The TQ is a tinnitus-specific health-related quality of life instrument with 52 statements that the respondent marks as true, partly true, or not true. The TQ is scored from 0 to 102, with higher scores indicating more of an impact of the tinnitus on quality of life. Subscales include emotional distress, intrusiveness, auditory perceptual difficulties, sleep disturbance,and somatic complaints.|Baseline to 3, 6, 12, and 18 months follow-up|Intention to treat, including data from all participants with at least one follow-up visit|||units on a scale||Standard Deviation|Mean
2726936|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 42||||percentage of donor cells||Standard Deviation|Mean
2709515|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.|Week 6|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
2709516|NCT01177098|Secondary|Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
2709517|NCT01177098|Secondary|Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
2709518|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.|Week 2|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
2709519|NCT01177098|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.|||mm Hg||Standard Deviation|Mean
2709520|NCT01177059|Primary|Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time|OZ1 and LNL6 marking analysis were performed by quantitative deoxyribonucleic acid-polymerase chain reaction (DNA-PCR). Number of participants in each of 3 categories for gene detection: Not Detected, Detected (1, 2 and 3 of the 3 triplicates of the sample were detected respectively [1/3 Detected, 2/3 Detected, 3/3 Detected]) and Detected (Quantifiable) were reported for marking of gene transfer product in PBMC.|Up to end of study (Approximately up to 15 years)|PP population set included all participants in safety population who received OZ1/LNL6 transduced final cell product in original OTH/OZ1-INT-1 study. Here ‘n’ specifies participants analyzed for this endpoint at given time point.|||Participants|||Number
2709521|NCT01177059|Primary|Percentage of Participants With Insertional Oncogenesis|Percentage of participants with insertional oncogenesis by clonal expansion of cells modified with OZ1/LNL6 were reported.|Approximately up to 15 years|Per protocol population set included all participants in the safety population who received OZ1 or LNL6 transduced final cell product in the original OTH/OZ1-INT-1 study.|||Percentage of participants|||Number
2709522|NCT01177059|Primary|Percentage of Participants With Clonal Expansion of Cells With a Predominant OZ1 Insertion Site|Percentage of participants with clonal expansion of cells with a predominant OZ1 insertion site was reported. A predominant integration site was defined as an integration site which has a density of at least 50 percent (%) of the total signal detected by polymerase chain reaction (PCR), when the percentage of cells marked by vector was greater than (>)1% of the test cell population.|Approximately up to 15 years|Per protocol (PP) population set included all participants in the safety population who received OZ1 or Moloney murine leukemia virus based retroviral vector (LNL6) transduced final cell product in the original OTH/OZ1-INT-1 study.|||Percentage of participants|||Number
2709523|NCT01177007|Secondary|Mean Radiation Dose Delivered to Total Liver|Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver.|24 hours|Mean radiation doses were calculated for the total cohort of participants and also stratified according to disease type - colorectal cancer, neuroendocrine, and non-CRC/non-NE.|||Gray||Standard Deviation|Mean
2709524|NCT01177007|Secondary|Safety as Graded by CTCAE Version 3.0|Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|12 months|50 participants were assessed for adverse events, with a total of 207 adverse events reported. Two patients had grade 5 toxicities (grade 5 cholecystitis and death), which were attributed to disease progression and were not device-related.|||adverse events|Adverse Events||Number
2709525|NCT01177007|Secondary|Overall Survival (OS) Rate at 2 Years|"Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as open-ended. At the time of results reporting, this outcome was presented as Up to 2 years. Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden."|Up to 2 years|2-year OS rate for all patients (n=50) were analyzed and also stratified based on tumor burden: Patients with tumor burden of 25% or less (n=34) and patients with tumor burden greater than 25% (n=16).|||percentage of participants|||Number
2709526|NCT01177007|Secondary|Overall Survival (OS)|"Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as open-ended. Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type."|Median follow-up time was 11.41 months (CI: 1.5-33.7)|Median OS for all patients (n=50) were analyzed and also stratified based on disease type: CRC (n=12); NE (n=26); and non-CRC/non-NE (n=12).|||months||95% Confidence Interval|Median
2709548|NCT01176955|Secondary|The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.|Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2709527|NCT01177007|Secondary|Tumor Response by the European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment.~Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions."|12 months|RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12). 7 out of the 50 patients were not analyzed due to lack of follow-up imaging.|||Participants|||Count of Participants
2709528|NCT01177007|Secondary|Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals.~Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|12 months|RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12).|||Participants|||Count of Participants
2709529|NCT01177007|Secondary|Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria|This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.|Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.|Analysis for TTP was not performed. In lieu of TTP, the PFS based on RECIST and EASL criteria was analyzed.||||||
2709530|NCT01177007|Primary|Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria|Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9.|2 years|Median PFS for all subjects and stratified based on disease type.|||months||95% Confidence Interval|Median
2709531|NCT01177007|Primary|Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria|This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.|Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.|These data were not collected. See outcome measure #2.||||||
2709532|NCT01176968|Secondary|Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.|Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||pg/mL||Inter-Quartile Range|Median
2709533|NCT01176968|Secondary|Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.|Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||μg/L||Inter-Quartile Range|Median
2709534|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.|Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||ng/mL||Inter-Quartile Range|Median
2709535|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.|Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen [ICTP], procollagen type I N-terminal peptide [PINP], procollagen type III N-terminal peptide [PIIINP], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||nmol/L||Inter-Quartile Range|Median
2709536|NCT01176968|Secondary|Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).|LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Centimeters (cm)||Standard Deviation|Mean
2709537|NCT01176968|Secondary|Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.|Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.|6 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Milliseconds (msec)||Standard Deviation|Mean
2709547|NCT01176955|Secondary|The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.|Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.|Baseline to 12 weeks||||percent change in lesion count||Standard Deviation|Mean
2709538|NCT01176968|Secondary|Second or Subsequent Non-fatal Myocardial Infarction (MI).|The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
2709539|NCT01176968|Secondary|Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).|The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Events|||Number
2709540|NCT01176968|Secondary|Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).|The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Events|||Number
2709541|NCT01176968|Secondary|First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).|The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.|||Events|||Number
2709542|NCT01176968|Secondary|First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.|The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
2709543|NCT01176968|Secondary|Diagnosis of Heart Failure|The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
2709544|NCT01176968|Secondary|Cardiovascular Mortality|The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
2709545|NCT01176968|Primary|First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off|Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.|0-24 months|The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.|||Events|||Number
2709546|NCT01176955|Secondary|The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.|All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.|12 weeks||||Spearman's Rank Correlation Coefficient|||Number
2726937|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 28||||percentage of donor cells||Standard Deviation|Mean
2709549|NCT01176955|Primary|The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.|Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.|12 weeks||||percentage of days containers were open||Full Range|Median
2709550|NCT01176877|Secondary|To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|before and 3 months after a 5 minute educational lecture|Patients enrolled who were available for phone contact 3 months following intervention.|||score on a scale||Full Range|Mean
2709551|NCT01176877|Primary|To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|immediately before and after a 5 minute educational lecture||||score on a scale||Full Range|Mean
2709552|NCT01176773|Secondary|Adverse Events||12 months|Intent-to-treat|||percentage of subjects|||Number
2709553|NCT01176773|Secondary|Number of Subjects Who Attain Their Lip Treatment Goal|"Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding yes as to whether their pre-established lip fullness treatment goal had been attained."|1-12 months|All subjects who provided a lip fullness goal achievement assessment|||percentage of subjects|||Number
2709554|NCT01176773|Secondary|Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale|The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.|3 months|All subjects with a Look and Feel assessment|||percentage of subjects|||Number
2709555|NCT01176773|Secondary|Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale|Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated in their oral commissures|||units on a scale||Standard Deviation|Mean
2709556|NCT01176773|Secondary|Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale|Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated for perioral lines|||units on a scale||Standard Deviation|Mean
2709557|NCT01176773|Primary|Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale|The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment|3 months|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2709558|NCT01176617|Secondary|Detection of Actionable Events Resulting in Change of Clinical Care|Change of clinical care include initiation of previously discontinued and/or new anti-arrhythmic drugs, decision for repeat ablation, hospitalization for arrhythmias, discontinuation or reinitiation of atrio-ventricular nodal blocking agents, discontinuation or reinitiation af anticoagulation after ablation and/or decision to implant a pacemaker and/or defibrillator.|12 months|Participants were monitored for this end point regardless of the randomization strategy to ensure patient safety.|||Participants|||Count of Participants
2709559|NCT01176617|Primary|Arrhythmia Burden|The primary outcome will be arrhythmia recurrences (atrial fibrillation and/or other atrial arrhythmias) after atrial fibrillation ablation over the initial 6 months and one year post-ablation as detected by the implantable loop recorder versus the conventional monitoring strategy. Months 1- 6 patients were being monitored by CM and ILR and in months 6 - 12 they were randomized to either ILR or CM.|6 and 12 months|Some participants withdrew before completing the full 1 year of required follow-up. In the first 6 months all 38 of the remaining patients arrhythmia recurrence was assessed using CM and Reveal XT. Participants were randomized in this phase to either CM or Reveal XT arms.|||Participants|||Count of Participants
2709577|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|preoperative, 4-6 weeks||||degrees||Standard Deviation|Mean
2709578|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|Preoperative, 4-6 weeks||||degrees||Standard Deviation|Mean
2709703|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
2709560|NCT01176565|Other Pre-specified|Any Serious Adverse Event Within the 90-day Study Period|The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data.|From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up.|Patients may have experienced more than one adverse event. This measure is designed to show the total count of any patients who experienced any type of serious adverse event, whether it was felt to be related to the study treatment or not, throughout the duration of their participation in the study.|||Participants|||Count of Participants
2709561|NCT01176565|Other Pre-specified|Treatment-related Serious Adverse Event Within 72 Hours of Randomization|Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly.|From randomization through 72 hours (3 days)|Relatedness is defined by the terms unrelated, unlikely, possibly, probably, or definitely related to the study treatment. Results are entered as the count of participants experiencing any serious adverse event within 72 hours of randomization that was determined by the site investigator to possibly or more have relationship to the study treatment.|||Participants|||Count of Participants
2709562|NCT01176565|Other Pre-specified|Hypotension Within 72 Hours|Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization.|From randomization through 72 hours from randomization|Blood pressure including the potential for hypotension was monitored according to intensive care unit standards for ICH patients during early hospitalization. Blood pressure was monitored more closely during the 24-hour study period and at times when nicardipine (or other/secondary IV antihypertensive medications) were being titrated.|||Participants|||Count of Participants
2709563|NCT01176565|Other Pre-specified|Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours.|Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change.|From randomization through the 24-hour treatment period|All subjects were assessed for neurological status regularly. Grid-estimated verbal scoring based on eye and motor scores was used for intubated patients so that GCS scores could be compared over time and was consistent across patients.|||Participants|||Count of Participants
2709564|NCT01176565|Secondary|Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.)|Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted.|From the baseline head CT to the 24 +/- 6 hours from randomization head CT|Participants with readable head CTs at baseline and 24 +/- 6 hours from randomization (submitted before data lock) were analyzed. Hematoma expansion was only recorded as present if ≥ 33% volume increase was calculated. Scans done outside of time window + margin, submitted after data lock, or not readable in standard DICOM format could not be used.|||Participants|||Count of Participants
2709565|NCT01176565|Secondary|Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores|Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.|90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization|All available valid data were analyzed. Outcomes collected outside of 90 ± 30 days weren't considered valid. EQ-5D data were missing for 28 patients in the intensive group & for 27 in the standard group. EQ VAS data were missing for 144 patients in the intensive group and for 146 in the standard group.|||units on a scale||Full Range|Median
2709566|NCT01176565|Primary|Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization|The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed.|90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization|All subjects were analyzed for known death at any time following randomization. Patients surviving through 90 days (± 14 days per protocol window; data used up to ± 30 days) were assessed for disability using the mRS. Patients not completing the 90-day visit within 30 days of due date aren't included in the death & disability participant counts.|||Participants|||Count of Participants
2709567|NCT01176513|Secondary|To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.|Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.|After GE-148 (18F) Injection administration|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.||||||
2709568|NCT01176513|Primary|To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.|Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.|After GE-148 (18F) Injection administration.|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.||||||
2709569|NCT01176448|Secondary|Visual Analog Scale for Assessing Scar Improvement.|"Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement~: 1-25% improvement~: 26-50% improvement~: 51-75% improvement~: 76-100% improvement"|3 months|"With 12 pairs of scars gave a 95% probability to detect a treatment difference at a two sided 0.05 significance level if a significant difference between treatments is 1.5 units (based on a 0~–4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units."|||units on a scale|Scar Halves|Standard Deviation|Mean
2709570|NCT01176448|Primary|Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing|Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.|Day 0, Week1, Month 1|Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.|||units on a scale|Scars|Standard Error|Mean
2709571|NCT01176435|Primary|Improved Vision|Binocular best-corrected visual acuity-The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart) or a card held 20 feet (6 meters) away. Special charts are used when testing at distances shorter than 20 feet (6 meters). Ranges are 20/10 vision to 20/200 vision. 20/10 being the best and 20/200 being the worse.|20 weeks||||logMAR||95% Confidence Interval|Mean
2709572|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|1 year||||degrees||Standard Deviation|Mean
2709573|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|4-6 months||||degrees||Standard Deviation|Mean
2709574|NCT01176292|Secondary|Oxford Knee Score|A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.|1 year||||score||Standard Deviation|Mean
2709575|NCT01176292|Secondary|Knee Society Score|A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.|1 year||||score||Standard Deviation|Mean
2709576|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|1 year||||degrees||Standard Deviation|Mean
2709579|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (AUCt)|The PK properties (AUCt) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters.|||h*ng/mL||Standard Deviation|Mean
2709580|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (Cmax)|The PK properties (Cmax) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters|||ng/mL||Standard Deviation|Mean
2709581|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (Tmax)|The PK properties (tmax) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters|||hours||Standard Deviation|Mean
2709582|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (Tlast)|The PK properties (tlast) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|[14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters]|||hours||Standard Deviation|Mean
2709583|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Tooth Loss|Effect of asfotase alfa treatment on tooth loss assessed by the proportion of patients who experienced tooth loss during the study|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Participants|||Count of Participants
2709584|NCT01176266|Secondary|Effect of Asfotase Alfa on Serum Parathyroid Hormone (PTH) - Change From Baseline to Last Obtained Value|Effect of asfotase alfa on serum PTH as measured by change from Baseline to last assessment for each patient|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||pmol/L||Full Range|Median
2709585|NCT01176266|Secondary|Effect of Asfotase Alfa on Biomarkers - Plasma Pyridoxal-5' Phosphate (PLP) Change From Baseline to Last Obtained Value|Effect of asfotase alfa on PLP as measured by change from Baseline to last assessment for each patient|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||ng/mL||Full Range|Median
2709586|NCT01176266|Secondary|Effect of Asfotase Alfa on Biomarkers - Plasma Inorganic Pyrophosphate (PPi) Change From Baseline to Last Obtained Value|Effect of asfotase alfa on PPi as measured by change from Baseline to last assessment for each patient|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||uM||Full Range|Median
2709587|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Physical Growth - Weight Z-scores Change From Baseline to Last Obtained Value|Effect of asfotase alfa treatment on physical growth as measured by change from Baseline to last assessment for each patient in weight Z-scores|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Z-score||Full Range|Median
2709588|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Physical Growth - Length/Height Z-scores Change From Baseline to Last Obtained Value|Effect of asfotase alfa treatment on physical growth as measured by change from Baseline to last assessment for each patient in length/height Z-scores|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Z-score||Full Range|Median
2709589|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Respiratory Function|Effect of asfotase alfa treatment on respiratory function as measured by the shift in proportion of patients requiring respiratory support at their last assessment compared with Baseline.|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Participants|||Count of Participants
2709590|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Ventilator-free Survival (Week 312)|For patients who were not on respiratory support at the time of enrollment, the Kaplan-Meier estimate of ventilator-free survival at the end of the study|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Patients on respiratory support at Baseline were excluded from the analysis.|||Probability|||Number
2709591|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Skeletal Manifestations of Hypophosphatasia (HPP)|The effect of asfotase alfa treatment on skeletal manifestations of HPP (i.e., change in rickets severity) was measured by radiographs using a qualitative Radiographic Global Impression of Change (RGI-C) scale. Skeletal radiographs obtained at the patient's last assessment were compared with skeletal radiographs obtained before initiation of treatment. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete healing of HPP-associated rickets).|Up to 72 Months or regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||scores on a scale||Full Range|Median
2709592|NCT01176266|Primary|Safety and Tolerability of Repeated Subcutaneous (SC) Injections of Asfotase Alfa|Safety and tolerability of repeated subcutaneous (SC) injections of asfotase alfa for all treated patients was assessed by the number of patients with 1 or more treatment-emergent adverse event.|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Participants|||Count of Participants
2709593|NCT01176266|Primary|Effect of Asfotase Alfa Treatment on Skeletal Manifestations of Hypophosphatasia (HPP)|The effect of asfotase alfa treatment on skeletal manifestations of HPP (i.e., change in rickets severity) was measured by radiographs using a qualitative Radiographic Global Impression of Change (RGI-C) scale. Skeletal radiographs obtained at Week 24 were compared with skeletal radiographs obtained before initiation of treatment. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete healing of HPP-associated rickets).|From Baseline to Week 24|Full Analysis Set|||scores on a scale||Full Range|Median
2709594|NCT01176240|Post-Hoc|Study 306A: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) From Baseline to Week 1|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|Last observation carried forward was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2709595|NCT01176240|Secondary|306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|The primary analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.|||units on a scale||Standard Deviation|Mean
2709596|NCT01176240|Secondary|306B Efficacy: Rate of Patient Reported Falls|The average number of patient reported falls per week.|up to 10 weeks|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.|||falls per week||Standard Deviation|Mean
2709597|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 8 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 8|The analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.|||units on a scale||Standard Deviation|Mean
2709598|NCT01176240|Secondary|306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1|Measure: Lowest standing systolic blood pressure reading of immediately post standing and 3 minutes post standing. Change: standing systolic blood pressure at Week 1 (Visit 4) minus standing systolic blood pressure at baseline. A positive score indicates an improvement in standing systolic blood pressure during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|One droxidopa patient did not complete the standing blood pressure measurements of the orthostatic standing test at visit 4 (one week of stable dosing)|||mmHg||Standard Deviation|Mean
2709599|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 4 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week4||||units on a scale||Standard Deviation|Mean
2709600|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 2 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week2||||units on a scale||Standard Deviation|Mean
2709601|NCT01176240|Post-Hoc|306A Efficacy: Patient Reported Falls|The total number of patient reported falls during the 8 week treatment period|Baseline, Week 8||||total falls per group|||Number
2709602|NCT01176240|Primary|306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week1|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2709603|NCT01176240|Primary|306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The primary efficacy endpoint for 306A is the relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|LOCF was used to impute values for patients who did not have an end of study visit.|||units on a scale||Standard Deviation|Mean
2709605|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at Follow-Up|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709606|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709607|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOIT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.|||percentage of participants||95% Confidence Interval|Number
2709608|NCT01176058|Secondary|Percentage of Participants With Clinical Response at Follow-Up|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709609|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709610|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOIT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709611|NCT01176058|Secondary|Percentage of Participants With Global Response at End of Treatment (EOT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).~Failure - Any case that did not meet the criteria for success."|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709612|NCT01176058|Primary|Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response).~Failure - Any case that did not meet the criteria for success."|End of Intravenous Treatment (Up to Day 42)|Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.|||percentage of participants||95% Confidence Interval|Number
2709613|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs|The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide|Baseline, Week 10,18,26|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||Patients|||Number
2709669|NCT01175824|Secondary|Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks||24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||participants|||Number
2709614|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline|The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline|Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||Patients|||Number
2709615|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate|Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)|Baseline, Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||Patients|||Number
2709616|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||mmHg||Standard Deviation|Mean
2709617|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||mmHg||Standard Deviation|Mean
2709618|NCT01176032|Secondary|Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||g/m2||Standard Deviation|Mean
2709619|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||cm3/m^2||Standard Deviation|Mean
2709620|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||mm/m^2||Standard Deviation|Mean
2709621|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||Percent||Standard Deviation|Mean
2709622|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ml||Standard Deviation|Mean
2709623|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine|The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/dl||Standard Deviation|Mean
2709624|NCT01176032|Secondary|Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/ml||Standard Deviation|Mean
2709625|NCT01176032|Secondary|Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||g/m^2||Standard Deviation|Mean
2709626|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||cm3/m^2||Standard Deviation|Mean
2709627|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||mm/m^2||Standard Deviation|Mean
2709628|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||Percent||Standard Deviation|Mean
2709629|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ml||Standard Deviation|Mean
2709630|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease|The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/dl||Standard Deviation|Mean
2709631|NCT01176032|Secondary|Change From Baseline in Biomarkers in Heart Disease|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/ml||Standard Deviation|Mean
2709632|NCT01176032|Primary|Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)|PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment.|||ug/l||Standard Deviation|Mean
2709633|NCT01175902|Secondary|OPP, Period 2|"OPP was calculated according to the following formula:~OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP~OPP after treaemt from week 8 to week 12"|12 weeks||||mmHg||Standard Deviation|Mean
2709634|NCT01175902|Secondary|Ocular Perfusion Pressure (OPP), Period 1|"OPP was calculated according to the following formula:~OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP"|4 weeks||||mmHg||Standard Deviation|Mean
2709635|NCT01175902|Primary|Blood Pressure (BP), Period 2|systolic and diastolic BP measured after treaemt from week 8 to week 12|12 weeks||||mmHg||Standard Deviation|Mean
2709636|NCT01175902|Primary|Blood Pressure (BP), Period 1|systolic and diastolic BP at 4 weeks after use of eyedrops|4 weeks||||mmHg||Standard Deviation|Mean
2709637|NCT01175902|Primary|Intraocular Pressure (IOP), Period 2|IOP (mean IOP) after treaemt from week 8 to week 12|12 weeks||||mmHg||Standard Deviation|Mean
2709638|NCT01175902|Primary|Intraocular Pressure (IOP), Period 1|IOP (mean IOP) after 4 weeks of treatment|4 weeks||||mmHg||Standard Deviation|Mean
2709639|NCT01175850|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Days||Standard Deviation|Mean
2709640|NCT01175850|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, stroke, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (ITT) (n=331)|||Percentage of participants|||Number
2709641|NCT01175850|Secondary|Procedural Success|Procedural success is defined as obtainment of ≤30% residual stenosis by visual estimate (with or without stenting)|Day 1|Intention-to-Treat (ITT) (n=331)|||Percentage of participants|||Number
2709642|NCT01175850|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).|||Percentage of devices|Devices||Number
2709660|NCT01175824|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.|||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
2709643|NCT01175850|Secondary|Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.~Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
2709644|NCT01175850|Secondary|Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.~EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|Baseline to 12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
2709645|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4).||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of particpants|||Number
2709646|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4).|Duplex ultrasound measurement that measures the peak systolic velocity of blood (cm/sec) within a lesion divided by the peak velocity of blood (cm/sec) proximal to the lesion.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2709647|NCT01175850|Secondary|Secondary Sustained Clinical Improvement|Freedom from target limb amputation and increase in Rutherford class.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of participants|||Number
2709648|NCT01175850|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class. Rutherford classification is a clinical staging system that is used to describe peripheral arterial disease.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of particpants|||Number
2709649|NCT01175850|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2709650|NCT01175850|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of amputations|||Number
2709651|NCT01175850|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.|||Days||Standard Deviation|Mean
2709652|NCT01175850|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2709653|NCT01175850|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2709654|NCT01175850|Secondary|All-cause Death||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of participants|||Number
2709655|NCT01175850|Secondary|Major Adverse Events (MAE) Composite|Major Adverse Events (MAE) composite defined as all-cause death, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, thrombosis at the target lesion site|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2709656|NCT01175850|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of Participants|||Number
2709657|NCT01175850|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.|12 Month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2709658|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
2709659|NCT01175824|Secondary|The Number of Participants With Severe Hypoglycemic Episodes|The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.|||participants|||Number
2709661|NCT01175824|Secondary|Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks|PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had PAM-D21 scores at 24 weeks.|||units on a scale||95% Confidence Interval|Least Squares Mean
2709662|NCT01175824|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks|ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had ITSQ scores at 24 weeks. Last observation carried forward (LOCF).|||units on a scale||95% Confidence Interval|Least Squares Mean
2709663|NCT01175824|Secondary|The Number of Participants With a Hypoglycemic Episodes (Incidence)|A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)].|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.|||participants|||Number
2709664|NCT01175824|Secondary|Change in Weight From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug and had evaluable body weight data at the specified time points.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
2709665|NCT01175824|Secondary|Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks||12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had dosing data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||international units (IU)||Standard Deviation|Mean
2709666|NCT01175824|Secondary|Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG glycemic variability data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||millimoles/liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2709667|NCT01175824|Secondary|7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2709668|NCT01175824|Secondary|Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, and 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had fasting plasma glucose concentration data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2709700|NCT01175668|Primary|Length of Treatment With Neonatal Morphine Sulfate||subjects were followed for the duration of treatment, up to 3 months||||days||95% Confidence Interval|Mean
2709670|NCT01175824|Secondary|Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint|The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at the 12 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
2709671|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Per protocol population: randomized participants with the exception of participants who did not complete Week 24 visit, received study drug different from their randomized study treatment, violated any of the inclusion, exclusion, or discontinuation criteria, or were significantly noncompliant.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
2709672|NCT01175811|Secondary|Percentage of Participants Experiencing a Severe Hypoglycemic Episode|Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.|||Percentage of participants|||Number
2709673|NCT01175811|Secondary|The Rate of Hypoglycemic Episodes|The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.|||hypoglycemic episode/30 days/participant||Standard Error|Mean
2709674|NCT01175811|Secondary|Percentage of Participants With Hypoglycemic Episodes (Incidence)|Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.|||percentage of participants|||Number
2709675|NCT01175811|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.|||International Units per kilogram (IU/kg)||Standard Deviation|Mean
2709676|NCT01175811|Secondary|Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.|||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
2709677|NCT01175811|Secondary|Daily Dose of Insulin: Total, Basal, and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.|||International Units (IU)||Standard Deviation|Mean
2709678|NCT01175811|Secondary|The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2709679|NCT01175811|Secondary|The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks|The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.|12 weeks, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.|||Percentage of participants|||Number
2709680|NCT01175811|Secondary|Change in HbA1c From Baseline to 12 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 12 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.|||percent HbA1c||95% Confidence Interval|Least Squares Mean
2709681|NCT01175811|Primary|Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.|||percent HbA1c||95% Confidence Interval|Least Squares Mean
2709682|NCT01175798|Secondary|Change in Immune Parameters|Secondary outcomes to be measured include change in peripheral blood mononuclear cell (PBMC) profile by flow cytometry at 6 and 12 months, change in ELISPOT-based panel of reactive T cell (PRT) readout at 6 and 12 months, change in PMBC cytokine production in response to toll-like-receptor stimulation at 6 and 12 months, and response to influenza vaccination.|1 year|||||||
2709683|NCT01175798|Primary|Change in 25OH-Vitamin D Level|Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.|1 year||||ng/dL||Inter-Quartile Range|Median
2709684|NCT01175707|Secondary|Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant|Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.|Day 1 up to Day 14|All study participants.|||US Dollars||Standard Deviation|Mean
2709685|NCT01175707|Secondary|Number of Laboratory Assessment Types During Home Infusion Therapy|There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough|Day 1 up to Day 14|All study participants.|||Assessments|||Number
2709686|NCT01175707|Secondary|Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.|Day 1 up to Day 14|All study participants.|||Assessments||Standard Deviation|Mean
2709687|NCT01175707|Secondary|Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.|Day 1 up to Day 14|All study participants.|||Participants|||Number
2709688|NCT01175707|Secondary|Number of Intervention Types During Home Infusion Therapy|There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.|Day 1 up to Day 14|All study participants|||participants|||Number
2709689|NCT01175707|Secondary|Mean Number of Interventions Per Participant During Home Infusion Therapy|Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.|Day 1 up to Day 14|All study participants.|||Interventions||Standard Deviation|Mean
2709690|NCT01175707|Secondary|Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy|Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.|Day 1 up to Day 14|All study participants.|||Participants|||Number
2709691|NCT01175707|Primary|Percentage of Treatment Goals Met at End of Therapy|"Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic.~Each participant's percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants' percentage of goals met by arm."|Day 1 up to Day 14|All study participants.|||Percentage of Goals Met||Standard Deviation|Mean
2709692|NCT01175707|Primary|Reasons for Pharmacist Consultations During Home Infusion Therapy|The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.|Day 1 up to Day 14|All study participants.|||Reason Cited|||Number
2709693|NCT01175707|Primary|Reasons for Nurse Visits During Home Infusion Therapy|The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.|Day 1 up to Day 14|All study participants.|||Reason Cited|||Number
2709694|NCT01175707|Primary|Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy||Day 1 up to Day 14|All study participants.|||Participants|||Number
2709695|NCT01175707|Primary|Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy||Day 1 up to Day 14|Number of Participants Analyzed based on number of participants with at least one nurse visit/pharmacist consultation within each treatment group results in 39 participants analyzed for the Daptomycin ARM group for this Outcome Measure.|||Participants|||Number
2709696|NCT01175707|Primary|Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy|Each participant is counted once per category.|Day 1 up to Day 14|All study participants.|||Visits or Consultations per Participant||Standard Deviation|Mean
2709697|NCT01175707|Primary|Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy|The mean duration in home-infusion antibiotic therapy per participant is presented.|Day 1 up to Day 14|All study participants.|||Days||Standard Deviation|Mean
2709698|NCT01175707|Primary|Time Spent (Minutes) for Home Infusion Therapy|Each participant is counted once per category. Avg=average; Admin=administer.|Day 1 up to Day 14|All study participants.|||Minutes||Standard Deviation|Mean
2709699|NCT01175668|Secondary|Total Dose of NMS Used||For the duration of treatment, upto 3 months||||mg/kg||95% Confidence Interval|Mean
2709704|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
2709705|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
2709706|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
2709707|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 11 (Visit 3)|Modified Intent-to-Treat Population|||eyes|Participants||Number
2709708|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 8 (Visit 2)|Modified Intent-to-Treat Population|||eyes|||Number
2709709|NCT01175590|Primary|Non-Ocular Treatment-Emergent Adverse Events|Non-Ocular Treatment-Emergent Adverse Events on the Study Eye|7 days|Safety Population|||Events|||Number
2709710|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 11 (Visit 3)|Study Eye, Modified Intent-to-Treat Population|||eyes|Participants||Number
2709711|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 8 (Visit 2)|Study Eye, Modified Intent-to-Treat Population|||eyes|Participants||Number
2709712|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.|Day 11 (Visit 3)|Study eye for the mITT population|||eyes|||Number
2709713|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data|Day 8 (Visit 2)|Study eye for the mITT population|||eyes|Participants||Number
2709714|NCT01175590|Primary|Ocular Treatment Emergent Adverse Events|Ocular Treatment-Emergent Adverse Events on the Study Eye|At each visit - 7 days|Safety Population|||Events|Participants||Number
2709715|NCT01175473|Secondary|Percentages of Patients by Ranges of Oxyntomodulin Levels|Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population. Here, 'n' signifies patients with oxyntomodulin assessment at the specified time point.|||percentage of participants|||Number
2709716|NCT01175473|Secondary|Change From Time-matched Baseline in Obestatin Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.|||nmol/L||Standard Deviation|Mean
2709717|NCT01175473|Secondary|Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.|||pmol/L||Standard Deviation|Mean
2709718|NCT01175473|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29|Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1).|Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)|PD population. Here, number of patients analyzed = patients with post-baseline HbA1c assessment.|||percentage of hemoglobin||95% Confidence Interval|Least Squares Mean
2709719|NCT01175473|Secondary|Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28|The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||h*pg/mL||95% Confidence Interval|Least Squares Mean
2709720|NCT01175473|Secondary|Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28|The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2709745|NCT01175382|Secondary|Patient Satisfaction|Patient global ratings of satisfaction using the validated Patient Satisfaction Question|From Baseline to 6 Weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
2709721|NCT01175473|Secondary|Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28|The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
2709722|NCT01175473|Secondary|Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28|The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
2709723|NCT01175473|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28|PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||mg/dL||95% Confidence Interval|Least Squares Mean
2709724|NCT01175473|Primary|Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28|The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|Pharmacodynamic (PD) population (modified intent-to-treat [mITT] population) included all randomized patients, who received at least 1 dose of lixisenatide or liraglutide, and had both a baseline assessment and at least 1 post-baseline assessment of any pharmacodynamic variable, irrespective of compliance with the study protocol and procedures.|||h*mg/dL||95% Confidence Interval|Least Squares Mean
2709725|NCT01175434|Secondary|Feasibility and Acceptability|We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.|one year|||||||
2709726|NCT01175434|Secondary|Cost Effectiveness|We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.|one year|||||||
2709727|NCT01175434|Primary|Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)|The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.|Average number of days, over 2 weeks, throughout the school year||||Days||Standard Deviation|Mean
2709728|NCT01175395|Secondary|To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis|Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.|30 to 360 days||||retreatments||Full Range|Median
2709729|NCT01175395|Primary|To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD|"The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.~The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit."|360 Days||||Number-participants with adverse events|||Number
2709730|NCT01175382|Secondary|Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)|Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|From Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2709731|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)|Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|From Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2709732|NCT01175382|Secondary|Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination|From Baseline to 12 weeks||||voids per day||Standard Deviation|Mean
2709733|NCT01175382|Secondary|Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|From Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2709734|NCT01175382|Secondary|Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia|From Baseline to 12 weeks||||voids per night||Standard Deviation|Mean
2709735|NCT01175382|Secondary|How Bothersome Were Side Effects? 12 Week Report|Ordinal Rating regarding how bothersome side effects were|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
2709736|NCT01175382|Secondary|Satisfaction With Progress at 12 Weeks|Patient global ratings of satisfaction using the validated Patient Satisfaction Question.|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
2709737|NCT01175382|Secondary|Patient Perception of Improvement at 12 Weeks|Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement.|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
2709738|NCT01175382|Secondary|Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)|Change from 6 weeks to 12 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|Change from 6 weeks to 12 weeks||||units on a scale||Standard Deviation|Mean
2709739|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)|Change from 6 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|Change from 6 week to 12 weeks||||units on a scale||Standard Deviation|Mean
2709740|NCT01175382|Secondary|Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia|Change from 6 weeks to 12 weeks||||Voids per night||Standard Deviation|Mean
2709741|NCT01175382|Secondary|Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.|Change from 6 weeks to 12 weeks||||Episodes per week||Standard Deviation|Mean
2709742|NCT01175382|Secondary|Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|Change from 6 weeks to 12 weeks||||units on a scale||Standard Deviation|Mean
2709743|NCT01175382|Secondary|How Bothersome Were Side Effects? 6 Week Report|Ordinal Rating regarding how bothersome side effects were|From Baseline to 6 weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
2709744|NCT01175382|Secondary|Patient Perceptions of Improvement|Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement|From Baseline to 6 Weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
2709849|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.|||% of participants|||Number
2709746|NCT01175382|Secondary|Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)|Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|From Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
2709747|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)|Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|From Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
2709748|NCT01175382|Secondary|Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia.|From Baseline to 6 Weeks||||voids per night||Standard Deviation|Mean
2709749|NCT01175382|Secondary|Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.|From Baseline to 6 Weeks||||episodes per week||Standard Deviation|Mean
2709750|NCT01175382|Secondary|Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|From Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
2709751|NCT01175382|Primary|Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination|Baseline to 12 weeks||||Voids per day||Standard Deviation|Mean
2709752|NCT01175382|Primary|Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.|Change from 6 weeks to 12 weeks||||Voids per day||Standard Deviation|Mean
2709753|NCT01175382|Primary|Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.|From Baseline to 6 Weeks||||voids per day||Standard Deviation|Mean
2709754|NCT01175369|Secondary|Additional Asthma Morbidity Outcomes|We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.|1-9 months (Monthly Follow-up assessments)|||||||
2709755|NCT01175369|Secondary|Cost Effectiveness of the Intervention|Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.|approximately 9 months (length of school year)|||||||
2709756|NCT01175369|Secondary|Cotinine Level|To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).|2 month and approximately 9 month (end of school year) follow-up assessments|||||||
2709757|NCT01175369|Primary|Number of Symptom Free Days|The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).|Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)||||Days||Standard Deviation|Mean
2709758|NCT01175356|Secondary|Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG|Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.|Up to 6 weeks after course 5 of induction|Includes patients who received 131I-MIBG therapy.|||Participants|||Count of Participants
2709759|NCT01175356|Primary|Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy|Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.|Up to day -6 of conditioning|Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning.|||Percentage of participants||95% Confidence Interval|Number
2709760|NCT01175356|Primary|Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131|Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.|Up to 6 weeks after course 5 of induction|Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG.|||Percentage of participants||95% Confidence Interval|Number
2709761|NCT01175343|Secondary|Impact of RO49097 on Ascitic Fluid Circulating Tumor Cells|Impact of RO49097 on ascitic fluid circulating tumor cells.|Up to 2 years|Data were not collected.||||||
2709762|NCT01175343|Secondary|Expression of Notch Biomarkers in Advanced Platinum Resistant Ovarian, Fallopian, and Primary Peritoneal Cancers.|An exploratory analysis for potential predictive biomarkers was performed on archival, paraffin-embedded tumor tissue for components of the Notch Pathway: Jagged-1 and NICD. The percentage of positive cells were scored into four categories: 0 (0%), 1 (1-33%), 2 (34-66%), and 3 (67-100%). The product of the intensity and percentage scores was used as the final score and classified as negative (0-4) or positive (5-9).|Up to 2 years|25 patients were assessed for Jagged-1 expression. 17 patients that were evaluable for response were assessed for NICD expression.|||Participants|||Count of Participants
2709763|NCT01175343|Secondary|Frequency and Severity of Adverse Events|Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 2 years|Adverse events analyzed include all serious adverse events (SAEs), and other (non-serious) treatment-related adverse events.There are 21 SAEs and 72 other (non-serious) adverse events.|||Adverse Events|Adverse Events||Count of Units
2709764|NCT01175343|Secondary|Overall Survival|Summary statistics, such as mean, median, counts and proportion, used to summarize the patients. Survival estimates computed using Kaplan-Meier method. Potential association between variables measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum tests may be substituted if necessary. Ninety-five percent confidence intervals will be constructed and selected results illustrated using figures and plots.|Up to 2 years|40 patients are evaluable for response.|||months||95% Confidence Interval|Median
2709765|NCT01175343|Secondary|CA125 Response Rate (GCIG Criteria)|"The CA-125 response rate is defined as the proportion of patients with a Gynecological Cancer Intergroup (GCIG) CA-125 response.~CA-125 response is defined as the moment CA-125 is reduced by 50% from the last pre-treatment level prior to start of therapy. The response must be confirmed and maintained with a consecutive CA-125 for at least 28 days."|Time from start of treatment to time of disease progression or death from any cause, whichever came first, assessed up to 2 years|There are 40 patients evaluable for response.|||Participants|||Count of Participants
2709766|NCT01175343|Secondary|Overall Response Rate|"Response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST 1.1).~Evaluation of Target Lesions:~Complete response (CR) - disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (PR) - at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Evaluation of Non-Target Lesions:~Complete response (CR) - disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis)."|Time from start of treatment to time of disease progression or death from any cause, whichever came first, assessed up to 2 years||||Participants|||Count of Participants
2709767|NCT01175343|Primary|Four Cycle Progression-free Survival Rate|"Defined as the proportion of the study population that has not had tumor progression (symptomatic, RECIST progression, CA-125 progression) or died at the completion of the cycle four mark.~RECIST criteria for progressive disease (PD) in target lesions: >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. In non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.~CA-125 PD is based on the progressive serial elevation of serum CA-125 according to:~A) elevated CA-125 pretreatment & normalization of CA-125 or C) CA-125 in normal range pretreatment: CA-125 >= 2x ULN on 2 occasions.~B) elevated CA-125 pretreatment that never normalizes: CA-125 >= 2x nadir value on 2 occasions"|84 days (4 courses)||||Participants|||Count of Participants
2709768|NCT01175317|Secondary|Average Intraoperative CO2 Gap|"The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively.~Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap."|Average intraoperative CO2 gap||||kPa||Standard Deviation|Mean
2709769|NCT01175317|Primary|Peak Value of I-FABP|"Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma.~The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group."|1 hour postoperatively||||pg/mL||Standard Deviation|Mean
2709770|NCT01175226|Primary|Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire|Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.|Days 2-4|Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.|||Scores on a scale||Standard Error|Least Squares Mean
2709771|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||Percentage of infusions|Infusions||Number
2709772|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2709850|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)||10-14 weeks||||% of participants|||Number
2709851|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks||10-14 weeks||||(no units; ratio of values)||Inter-Quartile Range|Median
2709773|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
2709774|NCT01175213|Secondary|"Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related)"|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2709775|NCT01175213|Secondary|"Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related)"|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
2709776|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2709777|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2709778|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe)~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2709779|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
2709780|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
2709781|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
2709782|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z).|"Categories presented as Preferred Term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Infection - Inf."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs|||Number
2709783|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs|||Number
2709784|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs|||Number
2709785|NCT01175213|Secondary|Percentage of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.|||Percentage of participants|||Number
2709786|NCT01175213|Secondary|Number of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.|||Number of participants|||Number
2709787|NCT01175213|Secondary|Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.~This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).~In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20|||Percentage of participants|||Number
2709788|NCT01175213|Secondary|Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.~This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).~In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20|||Number of participants|||Number
2709789|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||Percentage of infusions|Infusions||Number
2709790|NCT01175213|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||Percentage of infusions|Infusions||Number
2709791|NCT01175213|Secondary|The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs|"Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs).~Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20)."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||SAEs/year|||Number
2709792|NCT01175213|Primary|Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency|"Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals).~Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) [or IV infusions of IGSC, 10% only] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals).~After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG.~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set|||g/L||95% Confidence Interval|Median
2709793|NCT01175213|Primary|Annual Rate of All Infections|"Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) infections and infestations.~The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20|||Number of infections/year||95% Confidence Interval|Number
2709794|NCT01175213|Primary|Annual Rate of Serious Bacterial Infections|"The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20|||Estimated infections/year|||Number
2709795|NCT01175148|Primary|Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients|Cummalative incidence of grade 2 to 4 acute Graft vs Host Diesease (GVHD) at day 100 post transplant will be will be histologically confirmed and graded in Hematopoietic Stem Cell Transplantation Recipients|100 days post transplant|Only the Recipients were analyzed for the outcome measurements.|||percentage of participants||95% Confidence Interval|Number
2709796|NCT01175135|Secondary|Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|"Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement."|Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2709797|NCT01175135|Secondary|Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4|MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S * D * C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 [mild]; 2 [moderate]; 3 [severe]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.|Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2709798|NCT01175135|Secondary|Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4|ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.|Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2709799|NCT01175135|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin|Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein [HDL], low-density lipoprotein [LDL], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c [HbA1c] and Prolactin).|Day 1 up to Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2709800|NCT01175135|Secondary|Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)|Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.|Day 1 up to Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure|||participants|||Number
2709801|NCT01175135|Secondary|Number of Participants With Laboratory Test Abnormalities|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)|Screening up to end of study (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2709802|NCT01175135|Secondary|Number of Participants With Clinically Significant Changes in Physical Examinations|Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.|Screening, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2709803|NCT01175135|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)|Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction [QTcB] interval, and QT corrected using Fridericia's correction [QTcF]).|Baseline up to end of study (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2709804|NCT01175135|Secondary|Change From Baseline in Abdominal Girth at Week 4||Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||centimeter (cm)||Standard Deviation|Mean
2709805|NCT01175135|Secondary|Change From Baseline in Body Weight at Week 4||Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||kilogram (kg)||Standard Deviation|Mean
2709806|NCT01175135|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Week 4|FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2709807|NCT01175135|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4|GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.|Baseline, Week 4|FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2709808|NCT01175135|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: Compared to your subject's condition at the beginning of treatment, how much has your subject changed? Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected."|Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2709809|NCT01175135|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4|PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2709810|NCT01175135|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4|PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2709811|NCT01175135|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4|"CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question Considering your total clinical experience with this particular population, how mentally ill is your patient at this time? on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected."|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2709840|NCT01175031|Secondary|Device-Detected Clear Airway Apnea Agreement|Device Detected Clear Airways events were counted by the device. These events were then compared to manual PSG scoring. The manual PSG scoring determined that these were apnea events. However, the manual scoring allows for more channels to be reviewed and manual scoring was able to classify them into 4 different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored hypopneas and manually scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|335 Device Detected Clear Airway Apneas were detected.|||events|Device Detected Clear Airway Apneas||Number
2709812|NCT01175135|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4|PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2709813|NCT01175135|Primary|Proportion of Participants With Dystonia Adverse Events|Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.|Baseline up to end of study (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication.|||proportion of participants|||Number
2709814|NCT01175135|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Week 4|Full analysis set (FAS) included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2709815|NCT01175083|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period from Month 0 to Month 9|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccination.|||Participants|||Count of Participants
2709816|NCT01175083|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-primary and post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for the primary and booster epochs, which included all vaccinated subjects who received at least one dose of primary vaccination and the booster dose of study vaccine, respectively. Note that subjects from the 12-23 months of age groups did not participate in the Booster Epoch.|||Participants|||Count of Participants
2709817|NCT01175083|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase.|||Participants|||Count of Participants
2709818|NCT01175083|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination.|||Participants|||Count of Participants
2709819|NCT01175083|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase.|||Participants|||Count of Participants
2709820|NCT01175083|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination.|||Participants|||Count of Participants
2709821|NCT01175083|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.|Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against Bordetella pertussis were available at the specified time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2709822|NCT01175083|Secondary|Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine|Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.|Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against diphtheria and tetanus toxoids were available at the specified time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2709823|NCT01175083|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose|Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709824|NCT01175083|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose|Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709825|NCT01175083|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709826|NCT01175083|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose|Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709827|NCT01175083|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose|Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709841|NCT01175031|Secondary|Device-Detected Obstructed Airway Apnea Agreement|Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|762 Device Detected Apneas were detected.|||events|Device Detected Obstructed Airway Apneas||Number
2709828|NCT01175083|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709829|NCT01175083|Secondary|Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2709830|NCT01175083|Secondary|Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2709831|NCT01175083|Secondary|Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2709832|NCT01175083|Secondary|Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose|Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709833|NCT01175083|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose|Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.|||Titer||95% Confidence Interval|Geometric Mean
2709842|NCT01175031|Secondary|Device Detected Apneas as Detected by Philips Respironics (PR) System One|All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway.|During a single night of polysomnography lasting an average of 8 hours|1097 Device Detected Apneas were detected.|||events|Device Detected Events||Number
2709843|NCT01175031|Primary|Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography|The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.|During a single night of polysomnography lasting an average of 8 hours||||events/hour||Standard Deviation|Mean
2709834|NCT01175083|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.|||µg/mL||95% Confidence Interval|Geometric Mean
2709835|NCT01175083|Secondary|Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose|Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2709836|NCT01175083|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose|Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.|||µg/mL||95% Confidence Interval|Geometric Mean
2709837|NCT01175083|Secondary|Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2709838|NCT01175083|Primary|Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after the primary vaccination (Month 3)|The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2709839|NCT01175083|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines|Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after primary vaccination (Month 3)|The analysis was performed on the According To Protocol (ATP) immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3.|||µg/mL||95% Confidence Interval|Geometric Mean
2709844|NCT01175018|Secondary|Number of Adverse Events Requiring Withdrawal in Each Group||10-14 weeks||||adverse events|||Number
2709845|NCT01175018|Secondary|Number of Deaths in Each Group||10-14 weeks||||deaths|||Number
2709852|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks||||% (absolute change)||Inter-Quartile Range|Median
2709853|NCT01175018|Secondary|Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)||10-14 weeks||||% (absolute change)||Inter-Quartile Range|Median
2709854|NCT01175018|Secondary|Number of Adverse Events in Each Group||10-14 weeks||||adverse events|||Number
2709855|NCT01175018|Secondary|Incidence of Heart Failure|Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure|10-14 weeks||||participants|||Number
2709856|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks||10-14 weeks||||ml*kg^-1*min^-1||Inter-Quartile Range|Median
2709857|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)||10-14 weeks||||% of participants|||Number
2709858|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.|||mL/m2||Inter-Quartile Range|Median
2709859|NCT01175018|Primary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices|Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.|10-14 weeks minus baseline|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.|||mL/m2||Inter-Quartile Range|Median
2709860|NCT01175005|Primary|Procalcitonin Level at ED Presentation|Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.|Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.||||ng/dL||95% Confidence Interval|Mean
2709861|NCT01174784|Primary|CTO Crossing Success Using the Wildcat|Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.|||participants|||Number
2709862|NCT01174784|Primary|Major Adverse Events|The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.|||participants|||Number
2709863|NCT01174576|Primary|Total Energy Intake|the energy consumed at breakfast, ad libitum meal and rest of the experimental day|1 d||||kcal||Standard Deviation|Mean
2709864|NCT01174576|Primary|Energy ad Libitum Meal|The energy of first meal 3 hr after ingestion|3 hr post ingestion||||kcal||Standard Deviation|Mean
2709865|NCT01174576|Primary|Cortisol Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||ug*h/dL||Standard Deviation|Mean
2709866|NCT01174576|Primary|Insulin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||uU*h/ml||Standard Deviation|Mean
2709867|NCT01174576|Secondary|Serum Antioxidant Capacity Total Area Under the Curve|"Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer.~Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption."|15 min before ingestion to 21/2 hr post ingestion||||lag time (min) *h||Standard Deviation|Mean
2709868|NCT01174576|Primary|Glucose Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||mg*h/dl||Standard Deviation|Mean
2709869|NCT01174576|Primary|Interleukin-18 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||pg*h/mL||Standard Deviation|Mean
2709870|NCT01174576|Primary|Inteleukin-6 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||pg*h/mL||Standard Deviation|Mean
2709871|NCT01174576|Primary|Adiponectin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 h post ingestion||||ug*h/mL||Standard Deviation|Mean
2709872|NCT01174576|Primary|Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||ug*h/mL||Standard Deviation|Mean
2709873|NCT01174576|Primary|Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||pg*h/mL||Standard Deviation|Mean
2709874|NCT01174576|Primary|Ghrelin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||ug*h/mL||Standard Deviation|Mean
2709875|NCT01174563|Secondary|Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4|PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Day 1 of treatment period until disease progression or death (approximately up to 67 months)|"Efficacy set included all participants who received at least one dose of study drug. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||months||95% Confidence Interval|Median
2709876|NCT01174563|Secondary|Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4||Day 1 of treatment period until disease progression or death (approximately up to 67 months)|"Efficacy set included all participants who received at least one dose of study drug. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||percentage of participants|||Number
2709877|NCT01174563|Primary|Progression-free Survival (PFS) According to Grade of Rash|PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Day 1 of treatment period until disease progression or death (approximately up to 67 months)|"Efficacy set included all participants who received at least one dose of study drug. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||months||95% Confidence Interval|Median
2709878|NCT01174550|Secondary|Cumulative Radiation Exposure Within 90 Days|Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.|90 days||||milliSievert (mSv)||Inter-Quartile Range|Median
2709879|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing|Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing|6 month, 12 month 24 month|The number of participants were limited due to budget constraints.|||% of participants|||Number
2709880|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 months, 12 months, 24 months|The number of participants were limited due to budget constraints.|||participant score||Inter-Quartile Range|Median
2709881|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 month, 12 month, 24 month|The number of participants were limited due to budget constraints.|||participant score||Inter-Quartile Range|Median
2709882|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Duke Activity Status Index|Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline, 6 months, 12 months 24 months|The number of participants were limited due to budget constraints.|||participant score||Inter-Quartile Range|Median
2709883|NCT01174550|Secondary|Medical Cost|Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.|90 days and 3 years cumulative|Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.|||Per participant cost in US dollars||95% Confidence Interval|Mean
2709884|NCT01174550|Secondary|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization|Up to 90 days following participant randomization||||Percentage of events||Standard Error|Mean
2709885|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
2709886|NCT01174550|Secondary|Time to Major Complications From Cardiovascular (CV) Procedures|Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
2709887|NCT01174550|Secondary|Time to Death or Myocardial Infarction (MI)|Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
2709888|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization|Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
2709889|NCT01174550|Primary|Time to Primary Endpoint|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
2709890|NCT01174459|Secondary|Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)|International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.|after 12 months or at the end of observation|Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point.|||Score on a scale||Standard Error|Mean
2709891|NCT01174459|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 Months|Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.|||participants|||Number
2709892|NCT01174446|Secondary|Health Resource Use - Days Lost From Work or School||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Days||Full Range|Median
2709893|NCT01174446|Secondary|Health Resource Use - Unscheduled Doctor's Office Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Visits||Full Range|Median
2709894|NCT01174446|Secondary|Health Resource Use - Emergency Room Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Visits||Full Range|Median
2709895|NCT01174446|Secondary|Health Resource Use - Total Days of Hospital Stay||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Days||Full Range|Median
2709896|NCT01174446|Secondary|Health Resource Use - Number of Hospitalizations||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Hospitalizations||Full Range|Median
2709897|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haemo-QoL - Participants On-Demand (Ages 12-16)|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709898|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haem-A-QoL|The Haem-A-QOL instrument has been developed and used in hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: physical health, sports/leisure, school/work, dealing with hemophilia, and outlook for the future. For the Haem-A-QOL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709899|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Total Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709900|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Psychosocial Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709901|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Physical Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709902|NCT01174446|Secondary|SF-36: HRQoL General Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709903|NCT01174446|Secondary|SF-36: HRQoL Social Functioning|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709904|NCT01174446|Secondary|SF-36: HRQoL Vitality|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709905|NCT01174446|Secondary|SF-36: HRQoL Mental Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709906|NCT01174446|Secondary|SF-36: HRQoL Bodily Pain|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709907|NCT01174446|Secondary|SF-36: HRQoL Role-Emotional|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709908|NCT01174446|Secondary|SF-36: HRQoL Role-Physical (RP)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709909|NCT01174446|Secondary|SF-36: HRQoL Physical Functioning' (PF)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709926|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Weight-adjusted Consumption Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||IU/kg||Inter-Quartile Range|Median
2709910|NCT01174446|Secondary|SF-36: HRQoL 'Mental Health' (MH)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709911|NCT01174446|Secondary|Short Form (36) Health Survey (SF-36): HRQoL 'Physical Component Score' (PCS)|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709912|NCT01174446|Secondary|General Pain Assessment Through a Visual Analog Scale (VAS)|Participant rated assessment of health-related quality of life. The VAS Pain Scale rates current health state on a scale from 0 (no pain) to 100 (worst imaginable pain). For the pain scale, a higher score indicates worse pain.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709913|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions Visual Analogue Scale (EQ-5D VAS) Scores|Participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better quality of life.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709914|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Total Index Scores|EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2709915|NCT01174446|Secondary|Number of Participants With Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)||||participants|||Number
2709916|NCT01174446|Secondary|Number of Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||adverse events|||Number
2709917|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Thrombogenic Markers|Clinically significant changes in thrombogenic markers assessments for thrombin-antithrombin (TAT), prothrombin fragment 1.2, and D-dimer as evaluated by an independent Data Monitoring Committee (DMC)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709918|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Vital Signs|Clinically significant changes in vital signs assessments for pulse rate, systolic/diastolic blood pressure, respiratory rate, body temperature|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709919|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Hematology|Clinically significant changes in hematology assessments for Basophils, Basophils/Leukocytes, Eosinophils, Eosinophils/Leukocytes, Erythrocyte Mean Corpuscular Hemoglobin Concentration, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Lymphocytes/Leukocytes, Monocytes, Monocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes, Platelets,|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709920|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Clinical Chemistry|"Clinically significant changes in chemistry assessments for Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bicarbonate, Bilirubin, Blood Urea Nitrogen, Chloride, Glucose, Potassium, Protein (Serum), Sodium.~Clinically Significant (CS) defined as:~1. The abnormal value constitutes an adverse event (AE) and,~2. The abnormal value is a symptom of or related to a disease that is already recorded as an AE in Case Report Form (CRF)."|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709921|NCT01174446|Secondary|Number of Participants Who Experienced Thrombotic Events||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709922|NCT01174446|Secondary|Number of Participants Who Experienced Severe Allergic Reactions (e.g. Anaphylaxis)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709923|NCT01174446|Secondary|Occurrence of Treatment Related Total Binding Antibodies|Occurrence of treatment related total binding antibodies to Factor IX (FIX), antibodies to Chinese hamster ovary (CHO) proteins, and recombinant furin (rFurin) is defined by more than 2-dilution increase as compared to levels at screening visit and confirmed specificity (e.g. negative to 1:80)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709924|NCT01174446|Secondary|Occurrence of Total Binding Antibodies of Indeterminate Specificity (Within Assay Variability)|Occurrence of total binding antibodies of indeterminate specificity (within assay variability) to FIX, antibodies to CHO proteins and rFurin is defined by a dilution of 2 or less increase as compared to levels at screening visit (e.g. negative to 1:20 or 1:40).|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2709925|NCT01174446|Secondary|Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
2726938|NCT01043640|Secondary|Number of Patients Who Died Peri-Transplant|Peri-transplant is defined as within 100 days of transplant.|By Day 100 Post Transplant||||Participants|||Count of Participants
2709927|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Number of Infusions Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Infusions||Inter-Quartile Range|Median
2709928|NCT01174446|Secondary|Consumption of BAX326 Per Event Per Participant|Weight-adjusted consumption of BAX326 by event per participant, i.e., for prophylactic treatment and for treatment of bleeds until resolution of bleed.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set|||IU/kg||Inter-Quartile Range|Median
2709929|NCT01174446|Secondary|Total Weight-adjusted Dose Per Bleeding Episode (BEs) of All BEs Treated With BAX326 by Bleeding Site and Cause||Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set|||IU/kg|Bleeding Episodes|Inter-Quartile Range|Median
2709930|NCT01174446|Secondary|Hemostatic Efficacy at Resolution of All Bleeding Episodes (BEs) Treated With BAX326 by Bleeding Site and Cause|"Rating Scale for Treatment of BEs (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|At bleed resolution throughout the study period of 22 months (Study Parts 1, 2, and 3)|Full Analysis Set|||Bleeding episodes|Bleeding episodes||Number
2709931|NCT01174446|Secondary|Bleeding Episodes Treated With 1, 2 or ≥3 Infusions of BAX326 by Bleeding Site and Cause|The number of bleeding episodes treated with 1, 2, or ≥3 infusions of BAX326 to achieve adequate hemostasis. Only infusions required until resolution of bleed were considered.|Study Part 2 = 26 weeks ± 1 week (Study Part 2 began at week 3-5)|Full Analysis Set|||Bleeding episodes|bleeding episodes||Number
2709932|NCT01174446|Secondary|Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326|ABR during prophylaxis (twice-weekly) in Part 2 was calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25. The treatment period on prophylaxis was defined as time between the first and the last prophylactic infusions and ABR on prophylaxis was calculated for participants who received a minimum of 3 months of prophylactic treatment with BAX326.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set - Prophylactic cohort|||Bleeds per year||Inter-Quartile Range|Median
2709933|NCT01174446|Secondary|Study Parts 1 and 3: Volume of Distribution at Steady State (Vss)|"Vss computed as CL·MRT.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||dL/kg||Inter-Quartile Range|Median
2709934|NCT01174446|Secondary|Study Parts 1 and 3: Half Life (T 1/2)|"Elimination phase half-life will be determined as ln2/ λz.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||Hour||Inter-Quartile Range|Median
2709935|NCT01174446|Secondary|Change in Incremental Recovery (IR) at 30 Minutes Over Time|The median changes in IR at 30 Minutes, calculated as the change in IR value from exposure day 1 (ED1).|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
2709936|NCT01174446|Secondary|Incremental Recovery (IR) at 30 Minutes Over Time|"IR at 30 Minutes was measured at the following time points during the study:~Part 1 or Part 2, Exposure Day (ED) 1. (If participant was present for Study Part 1, then ED 1 from Part 1 was used. If Participant entered study in Study Part 2, then ED 1 from Part 2 was used.)~Part 2: Week 5~Part 2: Week 13~Part 2 or Part 3: Week 26 (Week 26 of study participation)~Study Completion or Termination Visit"|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
2709937|NCT01174446|Secondary|Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax)|"Defined as (Cmax - Cpre-infusion)/Dose, where maximum concentration (Cmax) will be determined as the highest concentration achieved within one hour after infusion.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 1 hour post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
2709938|NCT01174446|Secondary|Study Parts 1 and 3: Clearance (CL)|"Computed as Dose/ AUC0-∞.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||dL/(kg·hr)||Inter-Quartile Range|Median
2709960|NCT01174186|Secondary|Assessment Group in Ankylosing Spondylitis (ASAS) Core Set for Clinical Practice|clinical measurements of inflammation in spondyloarthritis patients as described by the Assessment Group in Ankylosing Spondylitis (ASAS)|one year|||||||
2709961|NCT01174186|Secondary|Spondyloarthritis Consortium of Canada Score|Inflammation on MRI assessed by the Spondyloarthritis Consortium of Canada score and a Danish scoring method|one year|||||||
2709939|NCT01174446|Secondary|Study Parts 1 and 3: Mean Residence Time (MRT)|"Computed as Area under the moment curve 0-∞ (AUMC0-∞) / AUC0-∞- TI/2, where AUMC0-∞ will be determined in a similar manner as AUC0-∞ and TI represents infusion duration [hr]~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||Hour||Inter-Quartile Range|Median
2709940|NCT01174446|Secondary|Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose)|"Defined as (AUC0-t + Ct)/ λz/ dose, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration. λz will be estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU·hr)/ dL/ (IU/kg)||Inter-Quartile Range|Median
2709941|NCT01174446|Primary|Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose|Computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.|72 hours|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU·hr/dL) / (IU/kg)||Inter-Quartile Range|Median
2709942|NCT01174368|Secondary|Progression-free Survival|No data was collected.|16 months|Data was not collected.||||||
2709943|NCT01174368|Secondary|Number of Metastases||16 months|Data was not collected. No statistical analysis was performed due to the sample size of one patient.||||||
2709944|NCT01174368|Primary|Overall Survival|Data was not collected.|16 months|Data was not collected.||||||
2709945|NCT01174342|Primary|Intraocular Pressure|Intraocular pressure during different stages of child delivery.|During child delivery|We included in the analysis all women completing vaginal delivery that had measurements of their intraocular pressure during most stages of labor.|||mm Hg||Standard Deviation|Mean
2709946|NCT01174264|Primary|Tmax Following Steady State Exposure for 14 Days|Time of maximum drug concentration.|24 hours||||hours||Standard Deviation|Mean
2709947|NCT01174264|Primary|AUC Following Steady State Exposure for 14 Days|Area under the curve from 0 to 24 hours.|24 hours|3 and 2 patients with missing data, respectively|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2709948|NCT01174264|Primary|Cmax Following Steady State Exposure for 14 Days|Maximum drug concentration over 24 hours.|24 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2709949|NCT01174264|Primary|Ctrough Following Steady State Exposure for 14 Days|Minimum blood concentration over 24-hour observation period. Blood sample collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 24 hours.|24 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2709950|NCT01174264|Primary|Tlag Following Single Dose of Drug|Time between drug administration and when it is first observed in the systemic circulation.|168 hours||||hours||Standard Deviation|Mean
2709951|NCT01174264|Primary|Tmax`Following Single Dose of Drug|Time of maximum drug concentration|168 hours||||hours||Standard Deviation|Mean
2709952|NCT01174264|Secondary|Objective Responses in Patients With Solid Tumors|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 30 days|2 patients in Arm I and 4 patients in Arm III were non-evaluable for response.|||participants|||Number
2709953|NCT01174264|Primary|AUC Following Single Dose of Drug|Area under the curve from 0-168 hours.|168 hours||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2709954|NCT01174264|Primary|Cmax Following Single Dose of Drug|Highest observed concentration over the 168 hour period. Blood samples were collected at j0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 24, 48, 120, and 168 hours.|168 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2709955|NCT01174238|Secondary|Increase From Nadir in the Sum of Maximum (18)F-FLT Uptake Values After Treatment Holiday|(18)F-FLT uptake values following a 7-day treatment holiday compared to the lower of Baseline or Day 14 value.|Baseline, Day 14, Day 20|Five patients completed both pre- and post-treatment (18)F-FLT PET scans; one patient had minimal (18)F-FLT uptake at baseline|||participants|||Number
2709956|NCT01174238|Secondary|Time to Progression (TTP)||within 7 days of odd cycles after cycle 1 for the duration of treatment, up to 12 cycles||||months||95% Confidence Interval|Median
2709957|NCT01174238|Secondary|Overall Survival (OS)|Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline until death or up to 24 months||||months||95% Confidence Interval|Median
2709958|NCT01174238|Secondary|Optimal Interval Between the End of Axitinib Therapy and Initiation of Chemotherapy|Optimal interval between the end of axitinib therapy and initiation of chemotherapy, as determined using FLT PET as a Radiological Biomarker information of Resumption of DNA Synthesis Following Axitinib Therapy.|Days 1, 14, 17, and 20 of cycle 1||||days|||Number
2709959|NCT01174238|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients with tumor size reduction, i.e. the sum of partial responses plus complete responses. Radiographic response was evaluated using RECIST criteria during every 21-day cycle of treatment.|Monthly during study treatment, up to 12 months|Two patients discontinued treatment due to toxicity within the first 3 weeks, prior to the first infusion of paclitaxel/carboplatin, and were considered to be evaluable for toxicity but not for response.|||percentage of patients|||Number
2709962|NCT01174186|Primary|Change in Intestinal Inflammation Measured by Faecal Calprotectin|"Feacal calprotectin is a protein and a marker of the degree of inflammation in the intestine, but not the site of inflammation.~We measured the level calprotectin continuously in each of the patients. Difference was inferred by repeated measurement ANOVA"|Baseline to 52 weeks|"15 patients in each group was included. 3 in the calprotectin negative group patients did not fulfill the entire study period (1 lost to follow-up, 2 withdrew consent).~Data analysed as last observation carried forward."|||mg/g||Inter-Quartile Range|Median
2709963|NCT01174186|Primary|Change Lewis Score Index|"Lewis' score describes the amount of inflammation seen optically by capsular endoscopy.~Gralnek et al. devised and validated the Lewis score index, based on three endoscopic parameters: villous edema, ulcer and stenosis/stricture. Using these parameters, the authors established a score range of 8-4,800 points where: LS < 135 reflects normal mucosal appearances, LS 135-790 mild mucosal inflammatory change and an LS value ≥790 moderate to severe mucosal inflammatory changes.~The patients had endoscopy performed at baseline and again after 20 weeks. The number of patients improving was compared to number of patients deteriorating"|20 weeks|Because endoscopy has a small risk for perforation. The study was designed so only patients with active inflammation at baseline had follow-up endoscopy performed. Because all patients with normal calprotectin levels had normal endoscopy, follow-up was only performed on this group of patients.|||units on a scale||Inter-Quartile Range|Median
2709964|NCT01174173|Secondary|Right Ventricular Hemodynamics|Mean pulmonary artery pressure was assessed invasively by right heart catheterization at the conclusion of the study to estimate right ventricular hemodynamics.|3 months|Analysis was performed on all participants who completed right heart catheterization at the conclusion of the study|||mm Hg||Standard Deviation|Mean
2709965|NCT01174173|Secondary|Absolute RV Longitudinal Strain|Change in absolute right ventricular (RV) longitudinal strain as assessed by exercise stress echocardiography with speckle-tracking echocardiography at baseline and conclusion of the study. An increase in exercise-induced change in RV longitudinal strain between baseline to conclusion of the study is indicative of improved RV function. If absolute RV longitudinal strain increases with exercise, that is a sign that the RV is working well. If absolute RV longitudinal strain decreases with exercise, that is a sign that the RV is not working well. Therefore, between baseline and conclusion of the study, if exercise-induced change in RV strain increases that means that the RV is working better at the conclusion of the study.|3 months|Analysis was performed on all participants who completed exercise stress echocardiography at baseline and conclusion of the study (month 3)|||percentage||Standard Deviation|Mean
2709966|NCT01174173|Secondary|RV Perfusion on Cardiac MRI|The majority of patients did not undergo cardiac MRI because it was difficult for the patients to tolerate the imaging study. Therefore, we were not able to assess change in RV perfusion.|3 months|||||||
2709967|NCT01174173|Primary|Improve Quality of Life|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The scores are averaged and transformed to a range of 0-100, in which higher scores reflect better health status and was performed at the conclusion of the study.|3 Months|Analysis was performed on the 8 participants who completed the KCCQ questionnaire at baseline and at the conclusion of the study (month 3)|||KCCQ Summary Score||Standard Deviation|Mean
2709968|NCT01174173|Primary|6-Minute Walk Test|Improve Exercise Capacity measured by 6-Minute Walk Test|3 Months|Analysis was performed in all participants who completed the study and had a 6-minute walk test at baseline and at the conclusion of the study.|||meters||Standard Deviation|Mean
2709969|NCT01174173|Primary|Improve Angina Symptoms|Assessed as average improvement in WHO Functional Class. The WHO Functional Class score ranges from 1 to 4, with higher scores indicating more impairment|3 months|Analysis was performed on all participants who completed as average change in WHO Functional class score from baseline to 3 months (Baseline, 3 months)|||units on a scale||Standard Deviation|Mean
2709970|NCT01174160|Primary|Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm|The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute|Within 90 minutes after first exposure||||participants|||Number
2709971|NCT01174082|Primary|The Rate of Partial Response(PR) and Complete Response(CR) in Patients Receiving DLI From an ID-specific Vaccinated Donor|PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.|DLI up to 5 years post DLI|The donor participant was to supply the cell product to manufacturer the vaccine. The donor has no disease and therefore cannot be analyzed for a response.|||Participants|||Count of Participants
2709972|NCT01174043|Other Pre-specified|Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts||Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12|||||||
2709973|NCT01174043|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.|up to 15 months||||participants|||Number
2709974|NCT01174043|Secondary|Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission|The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.|1 year after treatment discontinuation|All patients enrolled and received treatment|||months||Standard Deviation|Mean
2709975|NCT01174043|Primary|Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib|The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.|3 months of treatment with erlotinib|All patients enrolled and received treatment|||percentage of participants||95% Confidence Interval|Number
2709976|NCT01174030|Secondary|PSA-5 Success|"Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.~PSA-5 success defined as 2-grade improvement on PSA-5.~Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness~/ Very mild redness~/ Mild redness~/ Moderate redness~/ Severe redness"|day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.|||participants|||Number
2709977|NCT01174030|Secondary|CEA Success|"CEA success defined as 2-grade improvement on CEA.~Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.~Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema~/ Amost clear; slight redness~/ Mild erythema; definite redness~/ Moderate erythema; marked redness~/ Severe erythema; fiery redness"|Day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.|||participants|||Number
2709978|NCT01174030|Primary|Composite Success|"Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).~Each concentration/regimen was compared to its respective placebo control as part of the primary analysis."|Day 29|Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.|||participants|||Number
2709979|NCT01174004|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Study Days 1 and 43|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.|||Score on the UPDRS-II+III||95% Confidence Interval|Least Squares Mean
2709980|NCT01174004|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.~Analysis Method: Mixed Model Repeated Measures (MMRM)"|Each study visit (i.e. Days 1, 15, 29 and 43)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date."|||Score on the SAPS-PD scale||95% Confidence Interval|Least Squares Mean
2709981|NCT01173874|Secondary|Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)|"Total PANSS score with 30 items. Each item is rated 1-7 so the minimum Total PANSS score =30 and the maximum is 210. Anchors for each item are as follows, the higher values represent an increase in severity of symptoms:~Absent~Minimal~Mild~Moderate~Moderately severe~Severe~Extremely severe"|4-6 month period|Completed subjects|||units on a scale||Standard Deviation|Mean
2709982|NCT01173874|Secondary|Cognition as Measured by Cognitive Assessment Interview (CAI)|"Cognitive Assessment Interview was used to obtain information about cognitive functioning from both subject and an informant. Composite CAI scores were reported. Scale ranges from 1-7 with the following anchors:~Normal, no cognitive impairment~Borderline impairment~Mildly impaired~Moderately impaired~Markedly impaired~Severely impaired~Among the most extremely impaired"|4-6 month period|completed subjects with available completed CAI data. Numbers above are correct as not all completed subjects (Analysis Population Description) had completed CAI assessment available for analysis.|||units on a scale||Standard Deviation|Mean
2709983|NCT01173874|Primary|Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale|The UPSA-B assesses functional capacity to perform tasks similar to those in daily life. Raw scores are converted into scaled scores ranging from 0-100, with higher scores indicating better functional capacity.|4-6 month period|Completed subjects|||units on a scale||Standard Deviation|Mean
2709984|NCT01173874|Primary|Cognitive Function Measured by MCCB Composite Score|"The MATRICS Consensus Cognitive Battery (MCCB) will be used to assess cognitive function. The MCCB composite score is comprised of sub-scale measures of: a) working memory; b) attention and vigilance; c) verbal learning; d) visual learning; e) speed of processing; f) reason and problem solving; and g) social cognition. The MCCB takes 90 minutes or less to complete.~MCCB assessed 4 times: prestabilization (screening), randomization (after 6-8 weeks of lurasidone stabilization, prior to initial cognitive remediation), midpoint (after 20 cognitive remediation session), and study completion (final visit after 30 cognitive remediation sessions).~MCCB composite scores are reported as t-scores where a t-score = 50 is the population average. Every 10 points is one standard deviation. There is no range as scores are as far from population average."|4-6 month period|Completers|||units on a scale||Standard Deviation|Mean
2709985|NCT01173848|Primary|Subjects Achieving Normal Vitamin D Levels||within 24 weeks||||participants|||Number
2709986|NCT01173718|Secondary|Time to Potential Central Venous Catheter Removal|The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.|Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123|All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations|||days||Full Range|Median
2709987|NCT01173718|Secondary|Time to First Cannulation|The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.|Time of access placement to first cannulation, assessed up to one week|All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations|||percentage of grafts|||Number
2709988|NCT01173718|Secondary|Time to Event Analysis (Cumulative Patency)|The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.|6 Months|All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations|||percentage of participants||95% Confidence Interval|Number
2709989|NCT01173718|Secondary|Primary Unassisted Patency at 6 Months|The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.|6 Months|All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations|||percentage of participants|||Number
2709990|NCT01173718|Primary|Freedom From Bleeding at 6 Months|Percentage of subjects free from both major and minor bleeding events, assessed at 6-months|6 Months|All subjects with unknown bleeding status at the 6 month window were omitted from calculations|||percentage of participants||95% Confidence Interval|Number
2709991|NCT01173718|Primary|Cumulative Patency at 6 Months|Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.|6 Months|All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations|||percentage of participants||95% Confidence Interval|Number
2709992|NCT01173679|Secondary|Toxicities|Dasatinib may enhance the myelosuppression expected from fludarabine. This toxicity will be monitored with frequent CBC's. If after Day 21 of a cycle there is a grade 4 cytopenia, a dose reduction will occur in the next cycle of treatment, and that cycle cannot start until the ANC > 1,000 and the platelets > 25,000. There is also a risk for pleural effusions with dasatinib, but the risk will be low, since there is a break from dasatinib dosing on days 15-28 of each cycle. Nevertheless, if a grade 2 pleural effusion occurs, there will be a dose reduction in the next cycle of treatment.|2 years||||Participants|||Count of Participants
2709993|NCT01173679|Secondary|Progression-Free and Overall Survival|To describe the progression-free and overall surivial|2 years||||months||Inter-Quartile Range|Median
2709994|NCT01173679|Primary|Response Rate|To describe the response rate of complete response (CR) and partial response (PR) to treatment with this drug combination (SD=stable disease, PD=progressive disease)|2 years||||Participants|||Count of Participants
2709995|NCT01173653|Primary|Smoking Status at Follow up|Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm|6 weeks|Of subjects enrolled, 56 of the 109 subjects in the control arm and 49 of 90 subjects in the intervention arm were able to be contacted via phone and were willing to provide follow-up data for analysis of smoking status at the 6 week follow-up.|||percentage of participants|||Number
2709996|NCT01173601|Secondary|Pharmacokinetics: Plasma Concentrations of LY2216684|A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.|1 week, 4 weeks, and 8 weeks|Participants exposed to LY2216684 with evaluable plasma concentration values. Samples with concentrations below the lower quantification limit (BQL) of the assay were treated as missing values for the analysis and samples with incomplete dosing information were not included in the pharmacokinetics assessment.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2709997|NCT01173601|Secondary|Change From Randomization to Week 8 in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2709998|NCT01173601|Secondary|Change From Randomization to Week 8 in Blood Pressure (BP)|Blood pressure (BP) measurements were collected when the participant was in a sitting position. Three measurements of sitting BP collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2709999|NCT01173601|Secondary|The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype|Treatment-emergent adverse events (TEAEs) were events that first occurred or worsened during the treatment phase. CYP2D6 functional phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The percentage of participants who reported the TEAE is presented for each phenotype classification. Only TEAEs for which there was a statistically significant treatment-by-SSRI therapy interaction were included: tinnitus and influenza. A summary of serious and other non-serious adverse events regardless of causality is located in the Report of Adverse Events module.|Through 8 weeks|All randomized patients who do not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||percentage of participants|||Number
2710000|NCT01173601|Secondary|Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710058|NCT01173055|Other Pre-specified|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment||Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later|||||||
2710001|NCT01173601|Secondary|Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale|The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710002|NCT01173601|Secondary|Percentage of Treatment Emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a 'yes' answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a 'yes' answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as TE if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Randomization through 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2710003|NCT01173601|Secondary|Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing the worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710004|NCT01173601|Secondary|Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16-item questionnaire that measures degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point, Likert scale (1=very poor and 5=very good). The total raw score is the sum of items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of maximum possible score||Standard Error|Least Squares Mean
2710005|NCT01173601|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items|The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710006|NCT01173601|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710007|NCT01173601|Secondary|Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)|CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710026|NCT01173211|Secondary|Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.|||participants|||Number
2710807|NCT01167829|Primary|Mean Testosterone Concentration|initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2710008|NCT01173601|Secondary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710009|NCT01173601|Secondary|Change From Randomization to Week 8 in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710010|NCT01173601|Secondary|Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8|A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2710011|NCT01173601|Secondary|Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2710012|NCT01173601|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement|A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement, was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6 for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants with a baseline and at least one post-baseline value.|||percentage of participants|||Number
2710013|NCT01173601|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 up to Week 8|A MADRS total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6 for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
2710014|NCT01173601|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710037|NCT01173211|Secondary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected for HAI assay at approximately Day 180 following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.|||Titer||95% Confidence Interval|Geometric Mean
2710015|NCT01173601|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Scale|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Function Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710016|NCT01173601|Primary|Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
2710017|NCT01173523|Secondary|Overall Survival|Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death due to any cause or date last known alive.|Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
2710018|NCT01173523|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) based on RECIST 1.1 criteria or death. Participants alive without evidence of PD were censored at the date of last adequate disease assessment. Per RECIST 1.1 for target lesions PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression is appearance of one or more new lesions and/or unequivocal progression on existing non-target lesions.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2710019|NCT01173523|Secondary|Overall Response Rate|The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.|The analysis dataset is comprised of all treated patients.|||percentage of participants||95% Confidence Interval|Number
2710020|NCT01173523|Primary|8-Week Progression-Free Rate|The 8-week progression free rate is defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment.|The analysis dataset is comprised of all treated patients.|||percentage of participants||95% Confidence Interval|Number
2710021|NCT01173471|Secondary|Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set|||mmHg||95% Confidence Interval|Least Squares Mean
2710022|NCT01173471|Secondary|Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment||Baseline to 4 weeks|Efficacy analysis set|||Participants|||Number
2710023|NCT01173471|Primary|Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set|||Percentage change||95% Confidence Interval|Least Squares Mean
2710024|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.|||participants|||Number
2710025|NCT01173211|Secondary|HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.|||Titers||95% Confidence Interval|Mean
2710027|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Blood was collected from all participants prior to vaccination as well as at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the titer was 40 or greater at delivery, or the Day 0 titer was greater than or equal to 10 and the titer was an increase by 4-fold or more at delivery.|Day 0 prior to vaccination and at time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.|||participants|||Number
2710028|NCT01173211|Primary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 0 prior to and Day 28 after vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.|||participants|||Number
2710029|NCT01173211|Primary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 28 after vaccination||||participants|||Number
2710030|NCT01173211|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 following vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.|||Titers||95% Confidence Interval|Geometric Mean
2710031|NCT01173211|Secondary|Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.|||Titers||95% Confidence Interval|Geometric Mean
2710032|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.|||participants|||Number
2710033|NCT01173211|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
2710034|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
2710035|NCT01173211|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
2710036|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 180 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 180 post vaccination titer was an increase by 4-fold or more.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.|||participants|||Number
2710057|NCT01173055|Other Pre-specified|Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later|||||||
2710038|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
2710039|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving vaccination are included in the safety cohort|||participants|||Number
2710040|NCT01173211|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.|||participants|||Number
2710041|NCT01173211|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|During the pregnancy and at the time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.|||participants|||Number
2710042|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination|All participants receiving vaccination are included in the safety cohort|||participants|||Number
2710043|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly immunoglobulin (Ig) category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.|||participants|||Number
2710044|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.|||participants|||Number
2710045|NCT01173120|Primary|Mean Temperature Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||degrees Celsius||Standard Deviation|Mean
2710046|NCT01173120|Primary|Mean Heart Rate Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||beats per minute||Standard Deviation|Mean
2710047|NCT01173120|Primary|Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||mm Hg||Standard Deviation|Mean
2710048|NCT01173120|Primary|Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||mm Hg||Standard Deviation|Mean
2710049|NCT01173120|Primary|Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
2710050|NCT01173120|Primary|Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
2710051|NCT01173120|Primary|Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
2710052|NCT01173120|Primary|Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy|BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes: <0.75*BL; Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/ >1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/ >7.50*10^3 c/uL.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
2710053|NCT01173120|Primary|Number of Participants With AEs of Special Interest in the ACP Device Substudy|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing).|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of subcutaneous abatacept administered via the ACP.|||participants|||Number
2710054|NCT01173120|Secondary|Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy|Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device.|Days 1, 29, 57, 85, 169, and 253 of ACP substudy|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP. Trough concentrations in participants who discontinued from the substudy were not summarized descriptively, but were included in the concentration listings.|||ug/mL||Standard Deviation|Geometric Mean
2710055|NCT01173120|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
2710056|NCT01173055|Other Pre-specified|Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.||Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later|||||||
2710808|NCT01167829|Primary|Maximum Testosterone Concentration|initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2710059|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to End of Treatment|The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|baseline compared wtih 6 weeks of treatment|Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.|||kg/cm^2||Standard Deviation|Mean
2710060|NCT01173055|Secondary|Pain Tolerance at Baseline|The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.|Baselines measured at week 0 and week 9 after washout from first assignment to treatment||||kg/cm^2||Standard Deviation|Mean
2710061|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|baseline compared with 6 weeks of treatment|Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable. On the placebo, side one additional participant did not have data for this variable.|||units on a scale||Standard Deviation|Mean
2710062|NCT01173055|Secondary|Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|Baselines measured at week 0 and week 9 after washout from first assignment to treatment|One participant did not complete this outcome measure.|||units on a scale||Standard Deviation|Mean
2710063|NCT01173055|Primary|Change in Pain Threshold From Baseline to End of Treatment.|The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|baseline compared with 6 weeks of treatment|Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.|||kg/cm^2||Standard Deviation|Mean
2710064|NCT01173055|Primary|Pain Threshold at Baseline|The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm^2.|Baselines measured at week 0 and week 9 after washout from first assignment to treatment||||kg/cm^2||Standard Deviation|Mean
2710065|NCT01173029|Post-Hoc|Polygenic Risk Score|"Among all analyzed, four renin-angiotensin-aldosterone polymorphisms had statistical significance relating to composite endpoint.~They were: Angiotensinogen, renin, angiotensin II type 1 receptor and aldosterone synthase. Each polymorphism was arbitrarily weighted according to respective presentation in both alleles as follows: zero (low risk homozygosis), one (heterozygosis) and two (high risk homozygosis). In a following step, they were summed up for each subject, thus, creating a polygenic risk score.~The weights of the polymorphisms were, thus, defined:~Angiotensinogen: MM - zero, MT - one, TT - two~Renin: AA - zero, GA - one, GG - two~Angiotensin II type 1 receptor: CC - zero, AC - one, AA - two~Aldosterone synthase: CC - zero, TC - one, TT - two~The polygenic risk score value ranges from zero (all low risk polymorphisms in homozygosis) to eight (all high risk polymorphisms in homozygosis)."|up to 10 years|Subjects in both resistant systemic arterial hypertension and pseudo-resistant systemic arterial hypertension groups had their respective genetic background scored according to present rule.|||composite enpoint events|||Number
2710066|NCT01173029|Secondary|Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.~Evidence of clinically definite acute myocardial infarction (prolonged > 20min chest pain, not relieved by sublingual nitrate, ST-T segment deviation on 12-lead surface ECG, elevation of plasma troponin >0.2 ng/dL 6h following chest pain episode).~Death was considered to be related to the event if occurring up to 30 days after the acute event.~Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.~A post-hoc sampling procedure (power calculation) validated sample size."|||participants|||Number
2710067|NCT01173029|Primary|Strokes, Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.~Death was considered to be related to the event if occurring up to 30 days after the acute event.~Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.~A post-hoc sampling procedure (power calculation) validated sample size."|||participants|||Number
2710068|NCT01173016|Secondary|Correlation of 6 Minute Walk Test With Anti-laronidase Antibody + Status|"6 minute walk test (6MWT) was performed to assess overall physical function and health status. In brief, a 30m hospital corridor marked by colored tape at each end was used. Subjects were instructed to walk from end to end at their self-selected pace, while attempting to cover as much distance as possible in the 6 min. The patients were instructed to walk around the mark as they changed direction. The time and distance covered was recorded, as was the heart rate prior to and immediately after completion of the walk test.~To find the association between the rate of change in 6MWT, and anti drug antibody (ADA) titer, a statistical test is performed adjusting for age at the time of enrollment."|Assessed from baseline every 6 months through 2 years; change between baseline and 24 months reported.If baseline and/or 24-month data were not available, the longest interval between measurements was reported, with a minimum requirement of 12 months||||meters||95% Confidence Interval|Mean
2710069|NCT01173016|Secondary|Number of Participants With Changes in Cardiac Echo Structural Parameters|Pulse-wave and color Doppler interrogation of cardiac valves was performed for determination of valve regurgitation|Baseline and month 24|Two subjects didn't have both baseline and month 24 echo data|||Participants|||Count of Participants
2710070|NCT01173016|Secondary|Shortening Fraction to Determine Systolic Cardiac Function|Cardiac ultrasounds were obtained at baseline and month 24. Two-dimensional imaging was obtained for determination of anatomy. Shortening fraction (SF [normal > 27%]) was calculated by standard methods to determine the normal systolic cardiac function|Baseline and month 24|two subjects didn't have both baseline and month 24 echo data|||percentage of systolic cardiac function||Full Range|Mean
2710071|NCT01173016|Secondary|Number of Participants Showing Improvements in Joint Range of Motion (ROM)|Bilateral shoulder flexion, elbow extension, and hip extension were measured using goniometry. Improvements are defined for all joints as >5°.|Assessed from baseline every 6 months through 2 years; change between baseline and 24 months reported.If baseline and/or 24-month data were not available, the longest interval between measurements was reported, with a minimum requirement of 12 months||||Participants|||Count of Participants
2710072|NCT01173016|Secondary|"Change in Peak Heart Rate to Monitor Fitness"|A modified Balke Treadmill Test was performed. Briefly, patients began walking at 2.0 mph with a 2% increase in grade every 2 min. A 12-lead electrocardiogram was monitored continuously throughout the test for the determination of heart rate and dysrhythmias or ischemic changes. Heart rate was measured at the end of each stage (i.e. every 2 min) .|Assessed from baseline every 6 months through 2 years; change between baseline and 24 months reported.If baseline and/or 24-month data were not available, the longest interval between measurements was reported, with a minimum requirement of 12 months||||bpm||Standard Deviation|Mean
2710073|NCT01173016|Secondary|Change in Muscle Strength|Handgrip strength is measured three times in both hands with a mechanical handheld Biodex System 3 dynamometer (Biodex medical Systems, Inc., Shirley, NY) with the subject in a seated position at each visit; the average for each hand is presented.|Assessed from baseline every 6 months through 2 years; change between baseline and 24 months reported.If baseline and/or 24-month data were not available, the longest interval between measurements was reported, with a minimum requirement of 12 months||||kg||Standard Deviation|Mean
2710074|NCT01173016|Secondary|Changes in Growth Velocity|difference between baseline and month 24 growth velocities|Baseline, Month 24|Baseline growth velocity value was available in six of ten participants. One female participant was excluded from the within-group growth analyses due to a bone age of 14.5 years|||cm/year||Standard Deviation|Mean
2710075|NCT01173016|Primary|Number of Participants Experiencing Severe Adverse Events|Number of participants experiencing severe adverse events that occur after administration with Laronidase to determine the feasibility of giving weekly Laronidase|24 months||||Participants|||Count of Participants
2710076|NCT01173016|Primary|Percentage of Adherence to the Scheduled Weekly Infusion by the Participants|To determine the feasibility of giving weekly Laronidase for 2 years in patients with Hurler syndrome after allogeneic transplantation, compliance throughout the study with drug administration, the percentage of adherence to the scheduled weekly infusion for each participant is measured.|24 months||||percentage||Full Range|Median
2710077|NCT01172938|Secondary|Number of Participants With Adverse Events During the Apremilast-Exposure Period|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP) and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Baseline to Week 260; median total exposure to Apremilast was 170 weeks|Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||participants|||Number
2710078|NCT01172938|Secondary|Number of Participants With Adverse Events During the Placebo-Controlled Period|A Treatment Emergent Adverse Event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Week 0 to Week 16 for placebo participants who entered early escape at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population included all participants who were randomized and received at least one dose of IP.|||participants|||Number
2710079|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710142|NCT01172821|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|||weeks||95% Confidence Interval|Median
2710826|NCT01167582|Secondary|Unscheduled Hospital Admission|Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.|30 days||||Participants|||Count of Participants
2710080|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710081|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710082|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710083|NCT01172938|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants|||Number
2710084|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710085|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710086|NCT01172938|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710542|NCT01169350|Secondary|Disease Free Survival|Multivariate Cox regression will be used.|From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years|Study ended. No patients were assessed for disease free survival.No data were collected for this assessment||||||
2710087|NCT01172938|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710088|NCT01172938|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710089|NCT01172938|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710090|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710091|NCT01172938|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
2710092|NCT01172938|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710093|NCT01172938|Secondary|Change From Baseline in the SF-36 Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710094|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
2710827|NCT01167582|Secondary|Mortality From Cardiac Causes||30 days||||Participants|||Count of Participants
2710095|NCT01172938|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
2710096|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710097|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710098|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710099|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710100|NCT01172938|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710101|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710102|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710103|NCT01172938|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710104|NCT01172938|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710105|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710106|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710107|NCT01172938|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710108|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710158|NCT01172821|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
2710109|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710110|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710111|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710112|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710113|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710114|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710115|NCT01172938|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
2710131|NCT01172873|Secondary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.|||units on a scale||Standard Deviation|Mean
2710116|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: •78 tender joint count, •76 swollen joint count, •Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; •Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710117|NCT01172938|Secondary|Change From Baseline in SF-36 Physical Function at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710118|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2710119|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2710120|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2710121|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2710122|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2710123|NCT01172938|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
2710543|NCT01169350|Secondary|Overall Survival|Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.|Up to 2 years|Study ended. No patients were assessed for overall survival.No data were collected for this assessment.||||||
2710124|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710125|NCT01172938|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2710126|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
2710127|NCT01172938|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
2710128|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2710129|NCT01172938|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
2710130|NCT01172873|Secondary|Beck Depression Inventory (BDI)|Beck's Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures. Another was excluded because she was unable to provide reliable data on outcome measures.|||units on a scale||Standard Deviation|Mean
2710132|NCT01172873|Primary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents|The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.|||units on a scale||Standard Deviation|Mean
2710133|NCT01172847|Secondary|Number of Participants With Clinically Significant or Treatment Related Changes in Electrocardiogram (ECG)|ECG was recorded when participants were rested in a supine position for at least 5 minutes.|Screening; pre-dose on Day 1 and Day 5 of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
2710134|NCT01172847|Secondary|Number of Participants With Marked Abnormality in Laboratory Parameters|"Laboratory analysis included hematology (hemoglobin, hematocrit, erythrocytes, platelets counts, leukocytes counts, neutrophils, eosinophils, lymphocytes, basophils, and monocytes);, biochemistry (aspartate aminotransferase , alanine aminotransferase, gamma glutamyl trans peptidase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, albumin, creatinine, urea, creatine phosphokinase, total protein, sodium, chloride, calcium, phosphate, potassium, glucose (fasting), amylase, lipase, total cholesterol, and calculated creatinine clearance); and urinalysis.~Marked laboratory test values (high and low) falling outside the marked reference range and which also represents a clinically relevant change from baseline of at least a designated amount were recoded. In this study, marked abnormality ranges for phosphate as 0.75 - 1.60 millimole (mmol)/L and proteinuria (0 to 4+, and 1)."|Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
2710135|NCT01172847|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included heart rate (HR), blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), and body temperature. Blood pressure and pulse rate were recorded when participants were rested in a supine position for at least 5 minutes and after standing for 2 minutes. Vital signs values that fall outside the investigator's normal ranges were recorded.|Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
2710136|NCT01172847|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 11 weeks|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
2710137|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Rimantadine|Cmax of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.|||ng/mL||90% Confidence Interval|Least Squares Mean
2710138|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmax of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.|||ng/mL||90% Confidence Interval|Least Squares Mean
2710139|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine|AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetic analysis population included all participants who were adhered to the protocol.|||h*ng/mL||90% Confidence Interval|Least Squares Mean
2710140|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetics (PK) analysis population included all participants who were adhered to the protocol.|||hours (h)*nanogram (ng)/milliliter (mL)||90% Confidence Interval|Least Squares Mean
2710141|NCT01172821|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|||weeks||95% Confidence Interval|Median
2710159|NCT01172821|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
2710143|NCT01172821|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).|||Percentage of participants|||Number
2710144|NCT01172821|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS|||Days||Standard Error|Mean
2710145|NCT01172821|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Number of Puffs||Standard Error|Mean
2710146|NCT01172821|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
2710147|NCT01172821|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
2710148|NCT01172821|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS|||Percentage of Mean PEF||Standard Error|Mean
2710149|NCT01172821|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
2710150|NCT01172821|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
2710151|NCT01172821|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points.The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS|||Percentage of participants|||Number
2710152|NCT01172821|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items and ranges from from 0 (no symptoms) till 6 (highest intensity). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||units on a scale||Standard Error|Mean
2710153|NCT01172821|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|"Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment.~The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items and ranges from from 1 (highest intensity) till 7 (no symptoms). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week."|24 weeks|FAS|||units on a scale||Standard Error|Mean
2710154|NCT01172821|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre/min||Standard Error|Mean
2710155|NCT01172821|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
2710156|NCT01172821|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
2710157|NCT01172821|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
2710160|NCT01172821|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement.|||Litre||Standard Error|Mean
2710161|NCT01172808|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)|||weeks||95% Confidence Interval|Median
2710162|NCT01172808|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)|||weeks||95% Confidence Interval|Median
2710163|NCT01172808|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment)."|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)|||Percentage of participants|||Number
2710164|NCT01172808|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS|||Days||Standard Error|Mean
2710165|NCT01172808|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Number of Puffs||Standard Error|Mean
2710166|NCT01172808|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
2710167|NCT01172808|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
2710168|NCT01172808|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS|||Percentage of mean PEF||Standard Error|Mean
2710169|NCT01172808|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
2710170|NCT01172808|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
2710171|NCT01172808|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points. The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS|||Percentage of Participants|||Number
2710172|NCT01172808|Secondary|Total Asthma Control Questionnaire (ACQ) Score at the End of the 24-week Treatment Period|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||units on a scale||Standard Error|Mean
2710173|NCT01172808|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||units on a scale||Standard Error|Mean
2710174|NCT01172808|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre/min||Standard Error|Mean
2710175|NCT01172808|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
2710176|NCT01172808|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
2710177|NCT01172808|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
2710178|NCT01172808|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
2710179|NCT01172808|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
2710180|NCT01172808|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement excluding patients from one centre due to non-compliance with good clinical practice.|||Litre||Standard Error|Mean
2710181|NCT01172639|Secondary|Clinically Significant Change in HAQ Score|"Number of patients with a change of > 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104.~A change of > 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients."|Baseline-week104|ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710182|NCT01172639|Secondary|Remission According to SDAI at Week 104|"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity."|week 104|ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710183|NCT01172639|Secondary|Remission According to SDAI at Week 52|"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity."|week 52|ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710184|NCT01172639|Secondary|Remission According to SDAI (Simple Disease Activity Index) at Week 16|"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity."|week 16|ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710185|NCT01172639|Primary|Remission According to DAS28-CRP at Week 104|"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints)~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity."|week 104|ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710237|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|at baseline||||T-score||Standard Deviation|Mean
2710186|NCT01172639|Primary|Remission According to DAS28-CRP at Week 52|"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point)~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity."|week 52|ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710187|NCT01172639|Primary|Remission According to DAS28-CRP at Week 16|"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16.~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity."|week 16|ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.|||Participants|||Count of Participants
2710188|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|No blood sample was planned to be collected.||||||
2710189|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did come for the 3rd block. Among the patients who came for the 3rd block, blood sample was not collected in 5 Entonox patients and 1 Oxygen patient.|||pg/ml||Inter-Quartile Range|Median
2710190|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not come for 2nd block. Among patients came for the 2nd block, blood sample was not collected in 9 Entonox patients and 6 Oxygen patients.|||pg/ml||Inter-Quartile Range|Median
2710191|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|baseline - before 1st block|Blood sample was not collected for 5 Entonox patients and 1 Oxygen patients.|||pg/ml||Inter-Quartile Range|Median
2710192|NCT01172600|Secondary|Usage of Opioid||3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow up.|||participants|||Number
2710193|NCT01172600|Secondary|Usage of Opioid||3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 2nd block.|||participants|||Number
2710194|NCT01172600|Secondary|Usage of Opioids||2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.|||participants|||Number
2710195|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up.|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow-up.|||absolute percentage||Standard Deviation|Mean
2710196|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3rd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block.|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 3rd block.|||absolute percentage||Standard Deviation|Mean
2710197|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 2nd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block.|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.|||absolute percentage||Standard Deviation|Mean
2710198|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 3rd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 3rd block"|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 patients in the Entonox group and 26 patients in the Oxygen group did not receive the 2nd block treatment|||units on a scale||Standard Deviation|Mean
2710199|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 2nd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 2nd block."|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 patients in the Entonox group and 11 patients in the Oxygen group did not receive the 2nd block treatment|||units on a scale||Standard Deviation|Mean
2710200|NCT01172600|Primary|Change in VAS Pain Score From Baseline to 3 Month Follow-up|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to the 3 month follow-up."|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|For 10 patients with missing VAS at 3 month follow up: 5 patients who had 2nd or 3rd epidural block, we assigned the last VAS observation (i.e., from VAS before 2nd or 3rd block to 3 month follow-up); and for 5 patients who only had 1st epidural, we assigned the worst VAS (10) for Entonox patients and the best VAS (0) for Oxygen patients.|||units on a scale||Standard Deviation|Mean
2710201|NCT01172535|Primary|Proportion of Participants Tolerating LPV/r|Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.|Measured at study completion (week 24)|All participants|||proportion of participants||95% Confidence Interval|Number
2710202|NCT01172535|Primary|Number of Participants Experiencing Adverse Events of Grade 3 or 4|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death|Measured at study visits through end of study (weeks 2, 4, 12, 24)|All participants|||participants|||Number
2710203|NCT01172535|Secondary|Treatment Efficacy (CD4%)|Having CD4%≥25 at the week 24 visit.|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit|||proportion of participants||95% Confidence Interval|Number
2710204|NCT01172535|Secondary|Treatment Efficacy (HIV Viral Load)|Having HIV viral load <400 copies/mL at the week 24 visit|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit|||proportion of participants||95% Confidence Interval|Number
2710205|NCT01172535|Secondary|Adherence|Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)|Measured at week 4, week 12, and study completion (week 24)|Participants bringing medication to be measured at the study visit|||Proportion of expected doses taken||Inter-Quartile Range|Median
2710206|NCT01172535|Primary|Proportion of Participants With an AUC of Less Than 10% of Adults|Proportion of participants with an AUC less that 10% of adults (AUC0-24 <104 mcg*hr/mL)|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants with complete pharmacokinetics data at week 4|||proportion of participants||90% Confidence Interval|Number
2710207|NCT01172535|Primary|Clearance of Lopinavir/Ritonavir (CL/F)|Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||L/h/kg||90% Confidence Interval|Geometric Mean
2710208|NCT01172535|Primary|Minimum Concentration of Lopinavir/Ritonavir (Cmin)|Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||mcg/mL||90% Confidence Interval|Geometric Mean
2710209|NCT01172535|Primary|Maximum Concentration of Lopinavir/Ritonavir (Cmax)|Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||mcg/mL||90% Confidence Interval|Geometric Mean
2710210|NCT01172535|Primary|Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)|Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||mcg*hr/mL||90% Confidence Interval|Geometric Mean
2710211|NCT01172522|Primary|Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention|Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.|Baseline, weekly, and end of study +7 days|Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.|||participants|||Number
2710212|NCT01172418|Secondary|Patient Survival||at 3 years post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
2710213|NCT01172418|Secondary|Patient Survival||at 1 year post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
2710214|NCT01172418|Secondary|Graft Survival||at 3 years post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
2710215|NCT01172418|Secondary|Graft Survival||at 1 year post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
2710216|NCT01172418|Primary|Incidence of Acute Rejection at One Year Post-transplant||at one year post-transplant||||percentage of patients having BPAR|||Number
2710217|NCT01172353|Secondary|Dialysis During Hospitalization||During hospitalization||||participants|||Number
2710218|NCT01172353|Primary|Contrast-induced Nephropathy|rise in serum creatinine >0,5mg/dl|48 hours||||percentage of contrast nephropaty|||Number
2710219|NCT01172288|Secondary|Number of Participants With Adverse Effects|Number of participants with adverse events according to the Pediatric Adverse Events Rating Scale|12 weeks||||participants|||Number
2710220|NCT01172288|Secondary|Overall Improvement|Clinical Global Impression - Improvement Scale (CGI-I). The CGI is a 7-point scare that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.|12 weeks||||units on a scale||Standard Deviation|Mean
2710221|NCT01172288|Secondary|Improvement in OCD Severity|Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). 10-item scale. Each item is rated from 0-4. A sum total is calculated by adding items 1-10. 0-7: Subclinical. 8-15: Mild. 16-23: Moderate. 24-31: Severe. 32-40: Extreme.|12 weeks||||units on a scale||Standard Deviation|Mean
2710330|NCT01171690|Secondary|Safety Analysis|Arms were compared for total number of adverse events, including severe and serious adverse events.|Approximately 90 days after surgery||||events|||Number
2710580|NCT01169103|Primary|Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months|As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.|Baseline and 6 months||||mg/L||Standard Deviation|Mean
2710222|NCT01172288|Secondary|Improvement of Premonitory Urges|"Premonitory Urge for Tics Scale (PUTS). Items are rated on a scale of 1-4 from least to most. A total score is calculated by summing the scores of all items. Nine is the minimum possible score. A score of 12.5-24.5 indicates medium intensity of premonitory urges for tics. A score of 25-30.5 indicates high intensity which may be associated with marked impairment. Scores 31 and above indicate extremely high intensity with probable severe impairment. A score of 36 is the maximum score possible."|12 weeks||||units on a scale||Standard Deviation|Mean
2710223|NCT01172288|Primary|Improvement in Tic Severity|"Yale Global Tic Severity Scale is a standard psychiatric measure that rates tics from 0 (no tics) to 100 (most severe tics).~It separately rates motor tics and vocal tics in 5 subscales (number, frequency, intensity, complexity and interference) where the maximum severity score for motor tics is 25 and for vocal tics is 25. Giving us the Total Tic Severity Score maximum of 50.~The additional Impairment Scale rates the degree of disability caused by the tics ranging from 0 (none) to 50 (severe). When these two scores are added we get the Yale Global Tic Severity Scale Score."|12 weeks||||units on a scale||Standard Deviation|Mean
2710224|NCT01172275|Secondary|Overall Improvement at 12 Weeks|"Clinician Global Improvement Scale (CGI) 0=Not assessed 4=Moderately ill~Normal, not at all ill 5=Markedly ill~Borderline mentally ill 6=Severly ill~Mildly ill 7=Very much worse"|12 weeks||||score on a scale||Standard Deviation|Mean
2710225|NCT01172275|Primary|OCD Severity at 12 Weeks|Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (0-7:Subclinical, 8-15: Mild, 16-23: Moderate, 24-31: Severe, 32-40: Extreme)|12 weeks||||points on a scale||Standard Deviation|Mean
2710226|NCT01172197|Primary|Pain|Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion|30 hours|Knee replacement. All obtained pain relief defined as pain score = 0 on a verbal pain rating scale|||Participants|||Count of Participants
2710227|NCT01172184|Secondary|Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period|After discharge from index hospitalization of surgical intervention, heart failure with rehospitalization will be assessed. Heart failure with re-hospitalization was documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needed an augmented decongestive regimen during an in-hospital stay. The correlation between left atrial distensibility and heart failure was analyzed. ROC curve was used to estimate the best cut-off point.|1-2 years||||participants|||Number
2710228|NCT01172184|Secondary|Number of Participants With Post-operation Atrial Fibrillation|After operation, patients received continuous EKG monitor during the ICU stay. After transfer to ordinary ward, patients received 2 times of EKG record per day and another EKG would be done if patients felt palpitation and irregular heart beats were found by nursing staffs. The event of atrial fibrillation (Af) was defined as irregular irregular heart beats which was lack of p wave and last for more than 30 seconds. The relationship between left atrial distensibility and post-operative Af was analysed. ROC curve was used to assess the best cutoff value of left atrial distensibility.|baseline and 1 year||||participants|||Number
2710229|NCT01172184|Primary|Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization|Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.|1 year|Severe mitral regurgitation affects the accuracy of left ventricular filling pressure estimated by tissue Doppler imaging. Therefore, we conducted this study using left atrial parameters to assess left ventricular filling pressure in patients with severe mitral regurgitation.|||mmHg||Standard Deviation|Mean
2710230|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|after 8 weeks of treatment||||raw score||Standard Deviation|Mean
2710231|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|after 8 weeks of treatment||||raw score||Standard Deviation|Mean
2710232|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|after 8 weeks of treatment||||raw score||Standard Deviation|Mean
2710233|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|at baseline||||raw score||Standard Deviation|Mean
2710234|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|at baseline||||raw score||Standard Deviation|Mean
2710235|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|at baseline||||raw score||Standard Deviation|Mean
2710236|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|after 8 weeks of treatment||||T-score||Standard Deviation|Mean
2710238|NCT01172067|Primary|Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline|The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.|Baseline and12 months|A total of 108 patients in the QuickOpt group and 118 patients in the Echocardiography group had LVESV measurements at both baseline and 12 months to allow comparison of the percent change in LVESV.|||Percent change in LVESV||Standard Deviation|Mean
2710239|NCT01171989|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.|||Participants|||Count of Participants
2710240|NCT01171989|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.|||Participants|||Count of Participants
2710241|NCT01171989|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 8-day (Days 0-7) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2710242|NCT01171989|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.|During the 8-day (Days 0-7) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2710243|NCT01171989|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2710244|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710245|NCT01171989|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titres|Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2710246|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3|A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710247|NCT01171989|Secondary|Anti-HBs Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|At Month 0 and Month 1, before and after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2710248|NCT01171989|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values|The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710331|NCT01171690|Primary|Hospital Length of Stay|"Hospital length of stay from initiation of therapy with calcium and calcitriol to ready to discharge from a calcium perspective (calcium level > 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours)."|Approximately 7 days after surgery||||days||Standard Deviation|Mean
2710249|NCT01171989|Secondary|Anti-D and Anti-T Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2710250|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)|A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710251|NCT01171989|Secondary|Anti-PSC Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2710252|NCT01171989|Secondary|Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values|The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710253|NCT01171989|Secondary|Anti-rSBA-MenC Antibody Titres|Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2710254|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-rSBA-MenC|A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710255|NCT01171989|Secondary|Number of Seroprotected Subjects Against rSBA-MenC|A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.|At Month 0, before the booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710256|NCT01171989|Secondary|Anti-PRP Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2710257|NCT01171989|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off|The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710258|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-PRP|A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.|At Month 0, before the booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710259|NCT01171989|Primary|Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)|A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.|At Month 1, post-booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710260|NCT01171989|Primary|Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).|At Month 1, post-booster dose|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2710261|NCT01171976|Secondary|EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24|"The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= no problems, 2=some problems and 3=extreme problems . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction"|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2710262|NCT01171976|Secondary|Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2710263|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline and 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percent Change||Standard Deviation|Mean
2710264|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percent Change||Standard Deviation|Mean
2710265|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.|Baseline, 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percentage of pateints|||Number
2710266|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percentage of patients|||Number
2710267|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.|Baseline and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
2710268|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.|Baseline and Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
2710332|NCT01171677|Primary|Roesenberg Self Esteem|The Rosenberg Self-Esteem Scale is a 10-item, 4-point Likert scale used to assess global self-esteem. The scale ranges from 0-30 with higher scores indicating higher the self-esteem.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710269|NCT01171976|Secondary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.|Baseline to Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
2710270|NCT01171976|Primary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.|Baseline to Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
2710271|NCT01171963|Secondary|Concentrations of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 5 EL.U/mL) for all antibodies assessed (anti-PT, anti-FHA and anti-PRN). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2710272|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). A subject seropositive for anti-PT/anti-FHA/anti-PRN antibodies was defined as a subject with an anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710273|NCT01171963|Secondary|Titers for Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibodies|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seroprotection cut-off (≥ 8 estimated doses 50% [ED50] for anti-poliovirus type 1 [anti-polio 1]/anti-polio 2/anti-polio 3 antibodies. This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||titers||95% Confidence Interval|Geometric Mean
2710274|NCT01171963|Secondary|Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.|A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo (cf. population definition below).|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710275|NCT01171963|Secondary|Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||IU/mL||95% Confidence Interval|Geometric Mean
2710276|NCT01171963|Secondary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710377|NCT01171521|Primary|Quality of Life|"The SF-12 contains 12 items from the SF-36 Health Survey - . The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36.~The Quality of Life SF-12 is a scale from 0 - 100, in which 0 = poor functioning and 100 = excellent functioning."|6 months||||units on a scale||Standard Deviation|Mean
2710277|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.|||U/mL||95% Confidence Interval|Geometric Mean
2710278|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age.|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||U/mL||95% Confidence Interval|Geometric Mean
2710279|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||U/mL||95% Confidence Interval|Geometric Mean
2710280|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.|||Participants|||Count of Participants
2710281|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710282|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710283|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.|||Participants|||Count of Participants
2710284|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710285|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
2710286|NCT01171963|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination.|Throughout the entire study period (from Day 0 to Study End at Month 21)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.|||Participants|||Count of Participants
2710287|NCT01171963|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.|Within the 31-day (Days 0-30) follow-up periods following any dose of the Rotarix vaccine or placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.|||Participants|||Count of Participants
2710288|NCT01171963|Secondary|Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo|Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|Within the 8-day (Days 0-7) follow-up periods following Dose 2 of the Rotarix vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.|||Participants|||Count of Participants
2710289|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines|Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|Within the 8-day (Days 0-7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix vaccine|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.|||Participants|||Count of Participants
2710290|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo|Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix vaccine/placebo.|Within the 8-day (Days 0-7) follow-up periods after any dose of Rotarix vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.|||Participants|||Count of Participants
2710291|NCT01171963|Secondary|Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause|Severe GE was defined as an episode of GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
2710292|NCT01171963|Secondary|Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
2710293|NCT01171963|Secondary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
2710294|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
2710378|NCT01171183|Secondary|Retention|number of weeks each participant is on study protocol|12 weeks|Those eligible participants who entered the residential facility and received at least one dose of study medication. One person in the carvedilol group is excluded from all analyses due to not meeting inclusion criteria.|||Weeks||Standard Deviation|Mean
2710295|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
2710296|NCT01171963|Primary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
2710297|NCT01171924|Primary|Number of Participants With Adverse Events|Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.|12-15 months||||participants|||Number
2710298|NCT01171898|Secondary|Phase 1 and 2: Objective Response Rate|Objective Response Rate was defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). Where, CR defined as disappearance of all target lesions. Any pathological lymph nodes must had reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions. Confirmed responses were those that persisted on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to approximately 7 years|mITT population included all participants who received at least one dose of apalutamide and who were eligible for the cohort that they were enrolled in.|||Percentage of Participants||95% Confidence Interval|Number
2710299|NCT01171898|Secondary|Phase 1 and 2: Progression-free Survival (PFS)|PFS was defined as the time from randomization to the radiographic disease progression or death, whichever occurred first. Radiographic progression defined by at least one of the following: a) Soft tissue progression by modified RECIST confirmed on repeat imaging >= 6 weeks later; b) Progression by bone scans: 1) first bone scan with >= 2 new lesions compared to baseline observed <12 weeks from start date and confirmed on a second bone scan >=6 weeks later that showed >=2 additional lesions (a total of >=4 new lesions compared to baseline); or 2) first bone scan with >=2 new lesions compared to baseline observed >=12 weeks from start date and the new lesions verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline).|Up to approximately 7 years|mITT population included all participants who received at least 1 dose of apalutamide and who were eligible for cohort that they were enrolled in. PFS results are reported for Dose Escalation Cohort (Phase 1) and cohort 2, 3 (Phase 2) as no PFS analysis was performed for Cohort 1 of Phase 2 per planned analysis.|||Months||95% Confidence Interval|Median
2710300|NCT01171898|Secondary|Phase 2: Median Metastasis-Free Survival (MFS)|MFS was defined as the time from the start of treatment until new metastatic lesions were observed on Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) scans or radionuclide bone scans (according to PCWG2 criteria: appearance of >=2 new lesions, and, for the first reassessment only, a confirmatory scan performed 6 or more weeks later that showed at least 2 or more additional new lesions) or death, whichever occurred first.|Up to approximately 7 years|mITT population included all participants who received at least 1 dose of apalutamide and were eligible for cohort that they were enrolled in. MFS results are reported for Cohort 1 (Phase 2) participants only as MFS analysis was not performed for other cohorts that is Dose Escalation Cohort (Phase 1) and Cohort 2, 3 (Phase 2) per planned analysis.|||Months||95% Confidence Interval|Median
2710301|NCT01171898|Secondary|Phase 1 and 2: Median Time to PSA Progression|Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined by the PCWG2 criteria. PCWG2 criteria: For participants who achieved >=50% decrease from the baseline PSA, assessment of time to disease progression was when the PSA increased 25% and at a minimum of 2 ng/mL above the nadir at 3 or more weeks later. For participants without a PSA decrease, the time for progression was calculated at the time when the PSA progression was >=25% and >=2 ng/mL after 12 weeks.|Up to approximately 7 years|mITT population included all participants who received at least one dose of apalutamide and who were eligible for the cohort that they were enrolled in.|||Months||95% Confidence Interval|Median
2710302|NCT01171898|Primary|Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12|Percentage of participants with >=50% decrease in PSA compared to baseline were assessed at Week 12. PSA progression was defined by the protocol-specific Prostate Cancer Working Group 2 (PCWG2) criteria: PSA increase greater than or equal to [>=] 25 percent [%] and >=2 nanogram per milliliter [ng/mL] above the nadir confirmed >=3 weeks later; or >=25% and >=2 ng/mL above baseline PSA after 12 weeks.|Week 12|Modified intent-to-treat (mITT) population included all participants who received at least one dose of apalutamide and who were eligible for the cohort that they were enrolled in.|||Percentage of Participants|||Number
2710303|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710544|NCT01169350|Primary|Changes From Baseline Hypoxic Volume (HV)|ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.|Baseline and up to 2 years|Study ended with 8 patients imaged at baseline and only 3 patients had 18F FMISO following therapy.|||Cm^3||Standard Deviation|Mean
2710304|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710305|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710306|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710307|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710308|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710309|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710310|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710333|NCT01171677|Primary|Quality of Life (QoL)|The Quality of Life (QoL) assessment is adapted from Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The 23-item QoL consists of five subscales: physical health/activities, feelings, leisure time activities, social relations, and general activities. The scale ranges from 23-115; the higher score indicates higher quality of life enjoyment and satisfaction.|Baseline to end of intervention (week 14)|participants completing intervention|||units on a scale||Standard Deviation|Mean
2710311|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710312|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710313|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710314|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710315|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|365 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710316|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710375|NCT01171534|Primary|Performance of DermaClose System in Treatment of Fasciotomy Wounds|Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation|One year|Too low of an enrollment volume to analyze||||||
2710317|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|0 to 37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
2710318|NCT01171820|Secondary|In-segment Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.~This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percent diameter stenosis|Participants|Standard Deviation|Mean
2710319|NCT01171820|Secondary|In-stent Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.~This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percent diameter stenosis|Participants|Standard Deviation|Mean
2710320|NCT01171820|Secondary|In-segment Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percentage of participants|Participants|95% Confidence Interval|Number
2710321|NCT01171820|Secondary|In-stent Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percentage of participants|Participants|95% Confidence Interval|Number
2710322|NCT01171820|Secondary|Distal Late Loss|Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||millimeters|Participants|Standard Deviation|Mean
2710323|NCT01171820|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up|270 day|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||millimeters|Participants|Standard Deviation|Mean
2710324|NCT01171820|Secondary|In-segment Late Loss|In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||millimeters|Participants|Standard Deviation|Mean
2710325|NCT01171820|Secondary|Clinical Procedure Success (Per-patient)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.|immediately post-procedure|The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success.|||Percentage of participants||95% Confidence Interval|Number
2710326|NCT01171820|Secondary|Clinical Device Success (Per-lesion)|Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.|immediately post-procedure|Analysis based on intention to treat (ITT) population.|||Percentage of lesions|Participants|95% Confidence Interval|Number
2710327|NCT01171820|Primary|In-stent Late Loss (LL)|In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up.|||millimeters|Participants|Standard Deviation|Mean
2710328|NCT01171794|Primary|Acute Mountain Sickness Severity|Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms|2 days|Participants meeting all inclusion criteria were analyzed|||units on a scale||Standard Deviation|Mean
2710329|NCT01171794|Primary|Acute Mountain Sickness|Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness|2 days|Participants meeting all inclusion criteria were analyzed|||Participants|||Count of Participants
2710334|NCT01171677|Primary|Self-Efficacy for Abstinence|The Self-Efficacy for Abstinence assessment is adapted from DiClemente (1994)'s Alcohol Abstinence Self-Efficacy. The modified 10-item, 5-point Likert scale (Not at all to Extremely) assesses confidence in abstaining from alcohol. The scale is comprised of four subscales: negative affect, social/positive, physical and other concerns, and withdrawal and urges. Overall abstinence self-efficacy score is calculated by summing each item. The scale ranges from 10-50, the higher the score the higher the self-efficacy for abstinence.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710335|NCT01171677|Primary|Wechsler Test of Adult Reading (WTAR)|Wechsler Test of Adult Reading (WTAR) measures reading ability. The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710336|NCT01171677|Primary|Controlled Oral Word Association Test (COWAT)|Controlled Oral Word Association Test (COWAT) measures verbal fluency. The assessment consists of three trials; the total score is a sum of all three trials. The scale ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710337|NCT01171677|Primary|Digit Span|Digit span measures attention efficiency. The Digit-span task is used to measure verbal working memory. Two subscales, Digits Forward and Digits Backward, were combined for a total scale range from 0-30, the higher the score the better the working memory.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710338|NCT01171677|Primary|Trailmaking Test B|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline to end of intervention (week 14)|participants completing each arm|||seconds||Standard Deviation|Mean
2710339|NCT01171677|Primary|Trailmaking Test A|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline to end of intervention (week 14)|participants completing trial|||seconds||Standard Deviation|Mean
2710340|NCT01171677|Primary|Stroop Color/Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color-Word test is the third subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility and resistance to interference.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710341|NCT01171677|Primary|Stroop Color|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color test is the second subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710342|NCT01171677|Primary|Stroop Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Word test is the first subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710343|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recognition|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recognition is administered immediately after the HVLT Delayed Recall subscale and involves 12 forced choice responses. The HVLT Delayed Recognition scale ranges from 0-24, the higher score associated with greater recognition ability.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710344|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recall is administered 20-25 minutes after the HVLT Total Recall. The HVLT Delayed Recall scale ranges from 0-12, the higher score associated with greater retention.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710345|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Total Recall is the sum of 3 trials in which twelve words are read to and repeated back by subject. The HVLT Total Recall scale ranges from 0-36, the higher score associated with greater verbal learning.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
2710346|NCT01171625|Secondary|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'.|Baseline and 6 Months Post-Implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||units on a scale||Standard Deviation|Mean
2710347|NCT01171625|Secondary|Subject's Average Reticulocytes Percentage Over Time.|Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||percentage of reticulocytes||Standard Deviation|Mean
2710348|NCT01171625|Secondary|Subject's Average Haptoglobin Measurement Over Time.|Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||mg/dl||Standard Deviation|Mean
2710349|NCT01171625|Secondary|Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.|Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||U/L||Standard Deviation|Mean
2710350|NCT01171625|Secondary|Subject's Average Platelet Count Over Time.|Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||10^3 platelets per microliter||Standard Deviation|Mean
2710351|NCT01171625|Secondary|Subject's Average Hemoglobin Count Over Time.|Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||g/dl||Standard Deviation|Mean
2710352|NCT01171625|Secondary|Subject's Average Hematocrit Percentage Over Time.|Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||percentage of red blood cells||Standard Deviation|Mean
2710353|NCT01171625|Secondary|Subject's Average Red Blood Cells Count Over Time.|Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
2710354|NCT01171625|Secondary|Subject's Average White Blood Cell Count Measurement Over Time.|Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.|6 months and annually for 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||10^3 cells/microliters||Standard Deviation|Mean
2710355|NCT01171625|Secondary|Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.|Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Participants|||Count of Participants
2710356|NCT01171625|Secondary|Subject's Average Cardiac Index Measurements at 8 Years Post-implant.|Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||L/min/m^2||Standard Deviation|Mean
2710357|NCT01171625|Secondary|Subject's Average Cardiac Output Measurements at 8 Years Post-implant.|The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Liters per minute||Standard Deviation|Mean
2710358|NCT01171625|Secondary|Subject's Average Performance Index Measurements at 8 Years Post-implant.|Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||cm^2/cm^2||Standard Deviation|Mean
2710359|NCT01171625|Secondary|Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||centimeters squared/meters squared||Standard Deviation|Mean
2710376|NCT01171521|Secondary|Pain|Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The scale goes from 0 to 10 with 0 being no pain and 10 being the most severe pain imaginable. It is a visual analog scale so is continuous data.|6 months||||units on a scale||Standard Deviation|Mean
2710360|NCT01171625|Secondary|Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Centimeters Squared||Standard Deviation|Mean
2710361|NCT01171625|Secondary|Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.|Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||mmHg||Standard Deviation|Mean
2710362|NCT01171625|Secondary|Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant|Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size.|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||mmHg||Standard Deviation|Mean
2710363|NCT01171625|Secondary|Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days|Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.|1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||percentage of subjects||95% Confidence Interval|Number
2710364|NCT01171625|Secondary|Percentage of Late Adverse Events|Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occurring >= 31 days and up through 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available|||Percentage of events/late patient years|||Number
2710365|NCT01171625|Secondary|Percent of Early Adverse Events|Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.|Events occurring within 30 days of procedure|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Percentage of Early Adverse Events|||Number
2710366|NCT01171625|Primary|Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|8 Years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Participants|||Count of Participants
2710367|NCT01171625|Primary|Number of Subject's in NYHA Functional Class I or II at 8 Year Post‐Implant|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath)."|8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Participants|||Count of Participants
2710368|NCT01171625|Primary|Subject's Percentage of Long Term Safety Performance|"Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance.~Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event)."|31 days through 8 years post-implant|The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.|||Percentage of events/late patient years|||Number
2710369|NCT01171612|Secondary|Number of Patients With Adverse Events Related With Antiplatelet Therapy Management|"Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy~We create 3 categories:~Not withdrawal~Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy)~Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days"|90 days after surgery|MACCEs|||participants|||Number
2710370|NCT01171612|Secondary|Major Haemorrhagic Events|Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage|up to 90 days after surgery||||participants|||Number
2710371|NCT01171612|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCEs)|Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest|up to 90 days after surgery||||participants|||Number
2710372|NCT01171534|Secondary|Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure|Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.|One year|This study was terminated before this information was collected and analyzed.||||||
2710373|NCT01171534|Secondary|Quality of Life|Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year|This study was terminated before any of this information was collected and analyzed.||||||
2710374|NCT01171534|Secondary|Pain|Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year|too low of an enrollment volume to analyze||||||
2710379|NCT01171183|Primary|Urine Toxicology Screens|Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.|based on thrice weekly urine results during the 10-week outpatient phase|Those who completed the residential facility and attended at least one outpatient clinic visit to complete assessments.|||percentage of cocaine negative urines||Standard Deviation|Mean
2710380|NCT01171118|Primary|AHI - Apnea Hypopnea Index|This is a standard metric used to describe severity of disordered breathing during sleep.Normal healthy subjects would have an AHI value of zero during sleep. Mild disordered breathing would correspond to a value of 5 to 10 events per hours; moderate 10-25; severe would be over 25|2- 2 1/2 hours during study visit|This is a standard size for this type of sleep study and was performed per protocol.|||events per hour||Standard Deviation|Mean
2710381|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From day 8 post last dose of treatment up-to Week 72|Safety population included all treated participants.|||participants|||Number
2710382|NCT01170962|Secondary|Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.|||participants|||Number
2710383|NCT01170962|Secondary|Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.|||participants|||Number
2710384|NCT01170962|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)|SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2710385|NCT01170962|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2710386|NCT01170962|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2710387|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From first dose to last dose plus 7 days, up to 49 weeks|Safety population included all treated participants.|||participants|||Number
2710388|NCT01170962|Primary|Percentage of Participants With 24-week Sustained Virologic Response (SVR24)|SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2710389|NCT01170962|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4, Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2710390|NCT01170949|Primary|Urticaria Activity Score (% Change From Baseline)|"The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories number of wheals and intensity of pruritus. Number of wheals is scored as 0 = no wheals, 1 = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. Intensity of pruritus is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42."|Day 28|ITT = 73|||percentage of UAS baseline||Standard Deviation|Mean
2710391|NCT01170884|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 12|Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-Treat (ITT) included all subjects who were randomized to study medication.|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
2710581|NCT01169103|Primary|Changes in Lipid Panel|Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy|Baseline and 6 months||||mg/dL||Standard Deviation|Mean
2710392|NCT01170754|Other Pre-specified|Boston Prep Scale (Per Protocol Analysis)|"Analysis includes a sub-group of subjects who drank >75% of the preparation and adhered to a clear liquid diet (Per Protocol).~The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:"|photographs were taken throughout colonoscopy and reviewed within 1 month after procedure|Includes subjects who followed instructions (Per Protocol analysis)|||units on a scale||Standard Deviation|Mean
2710393|NCT01170754|Secondary|Phosphorus Level in mg/dl|Phosphorus level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
2710394|NCT01170754|Secondary|Magnesium Level in mg/dl|Magnesium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
2710395|NCT01170754|Secondary|Calcium Level in mg/dl|Calcium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
2710396|NCT01170754|Secondary|Glucose Level in mg/dl|Glucose level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
2710397|NCT01170754|Secondary|Creatinine Level in mg/dl|Creatinine level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
2710398|NCT01170754|Secondary|BUN Level in mg/dl|BUN level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
2710399|NCT01170754|Secondary|Bicarbonate Level in mmol/L|Bicarbonate level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
2710400|NCT01170754|Secondary|Chloride Level in mmol/L|Chloride level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
2710401|NCT01170754|Secondary|Potassium Level in mmol/L|Potassium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
2710402|NCT01170754|Secondary|Sodium Level in mmol/L|Sodium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
2710403|NCT01170754|Primary|Boston Prep Scale|"The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely.~The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:~0 = Unprepared colon segment with mucosa not seen due to solid stool.~= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen.~= Minor amount of residual staining, small fragments of stool and/or opaque liquid~= clear colon without staining"|photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.|Includes all subjects who were enrolled and underwent procedure (Intention-to-treat analysis)|||units on a scale||Standard Deviation|Mean
2710404|NCT01170663|Other Pre-specified|Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 103 weeks and within 30 days of last dose of study drug|All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.|||participants|||Number
2710405|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score|The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.|||units on a scale||Standard Deviation|Mean
2710828|NCT01167582|Secondary|Individual Components of Composite Outcome|All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.|30 days||||Participants|||Count of Participants
2710406|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status|EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.|||units on a scale||Standard Deviation|Mean
2710407|NCT01170663|Secondary|Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1 (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2710408|NCT01170663|Secondary|Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 (28-day cycle)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2710409|NCT01170663|Secondary|Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion|This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.|Cycle 1, Day 1 predose (28-day cycles)|Zero participants were analyzed.||||||
2710410|NCT01170663|Secondary|Cmax After 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2710411|NCT01170663|Secondary|Cmax After 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2710412|NCT01170663|Secondary|Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion||Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2710413|NCT01170663|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)|Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.|Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks|All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.|||percentage of participants|||Number
2710414|NCT01170663|Secondary|Percentage of Participants With CR or PR (Objective Response Rate [ORR])|ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2710415|NCT01170663|Secondary|Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD|BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.|||percentage of participants|||Number
2710416|NCT01170663|Secondary|Time to Progressive Disease (TTP)|TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.|Baseline up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.|||months||95% Confidence Interval|Median
2710435|NCT01170533|Primary|Platelet Function as Assessed by the P2Y12 Reactivity Index|P2Y12 reactivity index which will be assessed by flow cytometry determination of vasodilator-stimulated phosphoprotein (VASP).|1 week|A sample size of 18 patients was required to be able to detect a 10% absolute difference in PRI between both regimens with 80% power and 2-sided significance level of 0.05, assuming a 15% standard deviation for the difference between regimens.|||Percentage of platelet reactivity index||Standard Error|Least Squares Mean
2710436|NCT01170390|Secondary|EE Steady State After Randomization|Steady state levels of ethinyl estradiol (EE) post- randomization|Post-randomiziation 4 months||||ng/mL||Standard Deviation|Mean
2710417|NCT01170663|Secondary|Progression-Free Survival (PFS)|PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.|||months||95% Confidence Interval|Median
2710418|NCT01170663|Primary|Overall Survival Time (OS)|OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.|Randomization up to 27.5 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.|||months||95% Confidence Interval|Median
2710419|NCT01170598|Primary|Program Adherence.|Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate).|Baseline, Post-induction (weeks 4-6)||||percentage of exercise days completed|||Number
2710420|NCT01170598|Primary|Retention|Percentage of participants who remained in the study (did not withdraw voluntarily).|Baseline, Post-induction (weeks 4-6)||||percentage of participants|||Number
2710421|NCT01170598|Primary|Recruitment Rate|Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation).|Baseline|For this outcome measure we analyzed 52 participants (rather than 35). Fifty-two participants met the study eligibility criteria. Thirty-five out of 52 consented to participate which is how we derived our recruitment rate of 67% (35/52).|||percentage of patients|||Number
2710422|NCT01170598|Secondary|Development of Sepsis|Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).|Post-induction (weeks 4-6)||||percentage of participants|||Number
2710423|NCT01170598|Secondary|Intensive Care Unit (ICU) Admission|Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).|Post-induction (weeks 4-6)||||percentage of participants|||Number
2710424|NCT01170598|Secondary|Length of Stay|Length of stay (date of admission to hospital to date of discharge).|Post-induction (weeks 4-6)||||days||Standard Deviation|Mean
2710425|NCT01170598|Secondary|Fatigue|Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue.|Baseline, Post-induction (weeks 4-6)||||units on a scale||Standard Deviation|Mean
2710426|NCT01170598|Secondary|Global Quality of Life|Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL.|Baseline, Post-induction (weeks 4-6)||||units on a scale||Standard Deviation|Mean
2710427|NCT01170598|Primary|Grip Strength|Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis.|Baseline, Post-induction (weeks 4-6)||||kilograms||Standard Deviation|Mean
2710428|NCT01170598|Primary|Timed 10-chair Stands|Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.|Baseline, Post-induction (weeks 4-6)||||seconds||Standard Deviation|Mean
2710429|NCT01170598|Primary|6-minute Walk Test|Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score.|Baseline, Post-induction (4-6 weeks)||||feet||Standard Deviation|Mean
2710430|NCT01170598|Primary|Peak Aerobic Capacity (VO2peak)|The modified Bruce protocol is a walking-based treadmill test used to assess peak aerobic capacity. As the test progresses the intensity of each 3-minute work load increases. The test concludes when the participant reaches his maximal heart rate or volitional fatigue. The value attained on this test is measured in metabolic equivalents (METS). METS are a measure of exercise intensity and reflect the physical demands of an activity. In this context, a higher value achieved on the treadmill test (in METS) indicates work at a higher intensity and therefore a higher aerobic capacity.|Baseline, Post-induction (weeks 4-6)||||metabolic equivalent (METS)||Standard Deviation|Mean
2710431|NCT01170546|Primary|Age||before training||||year||Standard Deviation|Mean
2710432|NCT01170546|Primary|Isokinetic Strength|Cybex NORM (Cybex International, Inc, Ronkonkoma, New York, U.S.A.) was employed to evaluate isokinetic muscle strength before and after training.|one year||2010-12-31|12/2010||||
2710433|NCT01170546|Primary|Agility|shuttle run agility test|one year||2010-12-31|12/2010||||
2710434|NCT01170546|Primary|Static Knee Stability|The KT-2000 knee ligament arthrometer (MED Metric Co., San Diego, USA) is designed to assess the anterior drawer laxity of the knee joint. The discrepancy of anterior displacement between the sound side and the lesion side is applied in evaluating the static stability of the knee.|one year||2010-12-31|12/2010||||
2710437|NCT01170390|Secondary|EE Steady State Baseline|Steady state levels of ethinyl estradiol (EE) at baseline (2 months)|Baseline (2 months)|One subject discontinued prior to the completion of the baseline cycle in the Aviane/Aviane arm|||ng/mL||Standard Deviation|Mean
2710438|NCT01170390|Secondary|LNG AUC|Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.|baseline (2 months)||||hr*ng/mL||Standard Deviation|Mean
2710439|NCT01170390|Secondary|LNG AUC|Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.|post-randomization (4 months)||||hr*ng/mL||Standard Deviation|Mean
2710440|NCT01170390|Primary|LNG Steady State at Baseline and Then Post-randomization|The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).|baseline (2 months) and post-randomization (4 months)|One subject discontinued prior to the completion of the baseline studies in the Aviane/Aviane arm|||ng/mL||Standard Deviation|Mean
2710441|NCT01170364|Primary|24 Hour Measured Caloric Intake|The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.|1 week|This is a cross over design study. All participants received sibutramine and placebo. The sibutramine arm listed here includes all participants who received sibutramine (regardless of whether they received it first or second). The placebo arm included all those who received placebo (regardless of whether they received it first or second).|||kcal||Standard Deviation|Mean
2710442|NCT01170273|Primary|Change in Short Physical Performance Battery Test Score|The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.|baseline and 9 months||||units on a scale||Standard Deviation|Mean
2710443|NCT01170247|Primary|Onset of Sedation|Minutes it takes until the patient is cooperative enough for the procedure|Every 60 seconds through study completion||||Participants|||Count of Participants
2710444|NCT01170221|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.|||units on a scale||Standard Deviation|Mean
2710445|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the Day 7 Visit|Clinical improvement was defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2710446|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement was defined as improvement in overall clinical status.|48-72 Hour Visit|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2710447|NCT01170221|Secondary|To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized patients who received the minimal study therapy, completed EOT and PTE assessments, no concomitant systemic antibiotic therapy through PTE, and had no confounding events or factors.|||participants|||Number
2710448|NCT01170221|Secondary|Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set included data from all randomized participants.|||participants|||Number
2710449|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|EOT Day 11|All randomized patients receiving minimal study therapy, completed 48-72 Hour and EOT assessments, no concomitant systemic antibiotic therapy through EOT, and had no confounding events or factors|||participants|||Number
2710450|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.|Day 11|The ITT analysis set includes data from all randomized participants.|||participants|||Number
2710451|NCT01170221|Primary|Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|48-72 hours|The ITT analysis set includes data from all randomized participants.|||Responders|||Number
2710452|NCT01170208|Secondary|Incidence of Severe or Serious Hypoglycemia.||January 2011||||Participants|||Count of Participants
2710453|NCT01170208|Secondary|Reduction in Fructosamine.||12 week period from Week 4 to Week 16||||µM||Standard Deviation|Mean
2710454|NCT01170208|Secondary|Reduction in HbA1c.||Twelve week period from week 4 to week 16||||percentage of A1c||Standard Deviation|Mean
2710455|NCT01170208|Primary|Change in Weekly Mean Blood Glucose From Week 4 to Week 16||Twelve week period from week 4 to week 16|Per Protocol|||mg/dL||Standard Deviation|Mean
2710545|NCT01169311|Secondary|Quality of Life, Mental Component|quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation|Baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.|||units on a scale||Standard Deviation|Mean
2710456|NCT01170117|Primary|Psychological Change|Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.|Weekly during 16-week intervention and twice during 8-week follow-up||||YBOCs score units per month||Standard Deviation|Mean
2710457|NCT01170117|Primary|Rate of Weight Change|Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo|Weekly during 16-week trial and twice during 8 weeks follow-up|Patients assigned to receive placebo or olanzapine for 16 weeks.|||kg/m^2 per month||Standard Error|Mean
2710458|NCT01170091|Secondary|Clinical Global Impressions-Global Improvement (CGI-I)|"CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)|||patients|||Number
2710459|NCT01170091|Secondary|Patient-Global Impressions (PGI-I)|"PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)|||patients|||Number
2710460|NCT01170091|Secondary|International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment|"a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40"|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat)|||Units on a scale||Standard Deviation|Mean
2710461|NCT01170091|Primary|Number of Reported Adverse Events|If there is a dose titration, another 4 weeks should be followed up|Up to 4 weeks|Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set|||cases|||Number
2710462|NCT01170065|Secondary|Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug−Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs|Percentage of patients with at least one Adverse events (AEs), with investigator defined drug−related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented|From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days|TS|||Percentage of participants|||Number
2710463|NCT01170065|Secondary|Time to First Acute IPF Exacerbation|Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.|From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months|FAS|||percentage of participants||95% Confidence Interval|Number
2710464|NCT01170065|Secondary|Incidence of Patients With at Least One Acute IPF Exacerbation Over Time|Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100|From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months|FAS|||Exacerbations Per Year|||Number
2710465|NCT01170065|Secondary|Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented.~An exacerbation was defined as otherwise unexplained clinical features occurring within~1 month including all of the following:~Progression of dyspnoea over several days to 4 weeks~New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit~A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of <225 mmHg since the last visit~Exclusion of infection based on routine clinical practice and microbiological studies~Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc."|From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months|FAS|||Percentage of participants|||Number
2710466|NCT01170065|Secondary|Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease|"Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient.~Haemoglobin corrected DLCO was calculated for each patient using the following formulae:~Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented."|From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months|FAS|||mmol/min/kPa/yr||Standard Error|Mean
2710467|NCT01170065|Secondary|Progression−Free Survival|"Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression.~For presentation of progression−free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm."|From first trial drug intake in 1199.35 to disease progression; up to 61.8 months|FAS|||percentage of participants||95% Confidence Interval|Number
2710468|NCT01170065|Secondary|Overall Survival|"Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death.~For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm."|From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months|FAS|||percentage of participants||95% Confidence Interval|Number
2710578|NCT01169259|Primary|Number of Participants With Invasive Cancer of Any Type|Invasive cancer of any type|5 years||||Participants|||Count of Participants
2710469|NCT01170065|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC)|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate."|From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months|The full analysis set (FAS): which included all patients in the treated set who provided baseline data (for the first trial visit) for at least 1 endpoint in trial 1199.35|||milliliters per year (mL/ yr)||Standard Error|Mean
2710470|NCT01170039|Secondary|Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire|The difference in the scores on the self-reported Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The quality of life is measured by the by the overall scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, a validated 28-item questionnaire measuring quality of life as it pertains to constipation. The 28 items are grouped into four subscales, 1) worries and concerns, 2) physical discomfort, 3) psychosocial discomfort, and 4) satisfaction. A 5-point Likert response scale, ranging from 0 (Not at all/None of the time) to 4 (Extremely/ All of the time), is used. The subscale scores vary from 0 to 4 and the total (global) score ranges from 0 to 4. A lower score indicates better quality of life (QOL).|Screening, 8 weeks|7 subjects in the Lubiprostone arm and 7 subjects in the placebo arm did not complete the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire and therefore no data was analyzed for these subjects.|||scores on a scale||Standard Deviation|Mean
2710471|NCT01170039|Secondary|Number of Subjects With Daily Abdominal Discomfort|The number of subjects experiencing abdominal discomfort was recorded weekly.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|The number of participants in both arms was analyzed by Intention-to-Treat (ITT).|||participants|||Number
2710472|NCT01170039|Secondary|Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule|The duration of colonic transit time in hours was measured by the SmartPill pH Capsule. Colonic transit time is the time interval from the cecal entry of the capsule to anal expulsion and was measured in hours.|Baseline, 4 weeks|Intention to treat population.|||hours||Standard Deviation|Mean
2710473|NCT01170039|Primary|Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week|The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|Two subjects in the Lubiprostone arm did not complete the daily stool diary at baseline. No data was analyzed for these two subjects.|||spontaneous bowel movements||Standard Deviation|Mean
2710474|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of activity impairment||Standard Deviation|Mean
2710475|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)* [number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any data follow-up were available; n=number of participants with an assessment at given time point.|||percentage of TWPI||Standard Deviation|Mean
2710481|NCT01169987|Secondary|Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status|Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of affected BSA||Standard Deviation|Mean
2710476|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.|||percentage of impairment while working||Standard Deviation|Mean
2710477|NCT01169987|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with assessment at given time point.|||percentage of work time missed||Standard Deviation|Mean
2710478|NCT01169987|Secondary|DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of participants|||Number
2710479|NCT01169987|Secondary|Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2710480|NCT01169987|Secondary|Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|"The PGA was an evaluation of a participant's psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories Clear/Minimal or Mild/Moderate/Severe/Very Severe (M/Md/S/VS), and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)."|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of participants|||Number
2710482|NCT01169987|Secondary|PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of participants|||Number
2710483|NCT01169987|Secondary|Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at Baseline and given time point.|||percentage improvement||Standard Deviation|Mean
2710484|NCT01169987|Primary|Adalimumab Treatment Retention Status|Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for < 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.|Month 24/ Early Termination visit|Intention to Treat (ITT) set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.|||percentage of participants|||Number
2710485|NCT01169779|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2710486|NCT01169779|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2710487|NCT01169779|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2710499|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)|Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||pg/mL||Standard Deviation|Mean
2710488|NCT01169779|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with Baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2710489|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2710490|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2710491|NCT01169779|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2710492|NCT01169779|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2710493|NCT01169779|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2710494|NCT01169779|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2710495|NCT01169753|Primary|"Number of Participants With Fatigue Worst BFI Score"|"Efficacy defined by fatigue worst score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue."|After each 2 week treatment|No analysis completed, study stopped due to slow accrual with only one participant.||||||
2710496|NCT01169701|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up|The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.|Month 24|Intent to Treat (ITT): The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.|||Percentage of participants|||Number
2710497|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)|Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||mg/dl||Standard Deviation|Mean
2710498|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)|Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||ug/l||Standard Deviation|Mean
2710500|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)|Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||U/mL||Standard Deviation|Mean
2710501|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)|Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||Percentage of HbA1c||Standard Deviation|Mean
2710502|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)|Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||ng/ml||Standard Deviation|Mean
2710503|NCT01169701|Secondary|Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)|Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||mL/min/1.73m^2||Standard Deviation|Mean
2710504|NCT01169701|Secondary|Renal Function as Measured by Creatinine Clearance|Creatinine clearance was calculated using the Cockroft-Gault formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||mg/min||Standard Deviation|Mean
2710505|NCT01169701|Secondary|Renal Function Measured by Serum Creatinine|Serum samples were collected to analyze serum creatinine.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||mg/dl||Standard Deviation|Mean
2710506|NCT01169701|Secondary|Percentage of Participants With Major Cardiovascular Events (MACE)|The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.|Month 24|The Intent to Treat (ITT) analysis set: The ITT included participants who received at least one dose of study medication and had at least one post baseline LVMI value.|||Percentage of participants|||Number
2710507|NCT01169701|Secondary|Pulse Wave Velocity (PWV)|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|Month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||m/sec||Standard Deviation|Mean
2710508|NCT01169701|Secondary|Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure|Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.|Baseline, Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||mmHg||Standard Deviation|Mean
2710509|NCT01169701|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI)|Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.|Baseline, Month 24|Participants from the Intent to Treat (ITT) analysis set, who had both baseline and month 24 values, were analyzed. The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.|||g/m^2.7||Standard Deviation|Mean
2710510|NCT01169675|Secondary|Tumour Shrinkage|Tumour shrinkage is defined as the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set: all patients that received treatment of Afatinib or Pemetrexed and who were evaluated for the longest diameter of the target lesions.|||participants|||Number
2710511|NCT01169675|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurence of tumour progression or death, whichever came first. It was assessed according to RECIST version 1.1 criteria.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||months||95% Confidence Interval|Median
2710512|NCT01169675|Secondary|Disease Control|Disease Control is defined as complete response, partial response, or stable disease according to the response evaluation criteria in solid tumours (RECIST) version 1.1.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||participants|||Number
2710579|NCT01169103|Primary|Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months|Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk|Baseline and 6 months||||ng/mL||Standard Deviation|Mean
2710513|NCT01169675|Secondary|Objective Response (OR)|"Objective Response is defined as complete response or partial response according to the response evaluation criteria in solid tumours (RECIST) version 1.1.~Complete Response (CR): disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR): at least 30% decrease of the sum of longest diameter (LD) of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions together with an absolute increase in the sum of LD of at least 5 millimeters; Stable Disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD."|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||participants|||Number
2710514|NCT01169675|Secondary|Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set|Occurence of DLT during all courses of treatment with Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during all cycles of treatment|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||participants|||Number
2710515|NCT01169675|Primary|Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set|Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during the first cycle (days 1-21)|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed that who were evaluable for MTD determination|||participants|||Number
2710516|NCT01169649|Primary|Overall Response.|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|every 12 weeks||||participants|||Number
2710517|NCT01169610|Secondary|Tolerability of Varenicline|Tolerability will be defined by the number of adverse events experienced by patients.|Two years|data not analyzed for 1 participant enrolled||||||
2710518|NCT01169610|Secondary|Prolonged Smoking Abstinence|"Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx? Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD).~Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained."|Two years|data not analyzed for 1 participant enrolled||||||
2710519|NCT01169610|Secondary|7-day Point Prevalence Smoking Abstinence|"Negative response to the question, Have you used any type of tobacco, even a puff, in the past 7 days. This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) < 8 parts per million (ppm) during the medication phase."|Two years|data not analyzed for 1 participant enrolled||||||
2710520|NCT01169610|Primary|Heavy Drinking Days|Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.|Two years|data not analyzed for 1 participant enrolled||||||
2710521|NCT01169610|Primary|Continuous Alcohol Abstinence|No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.|Two years|Data not analyzed for 1 participant enrolled||||||
2710522|NCT01169558|Secondary|Efficacy: Progression-free Survival|Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.|||months||95% Confidence Interval|Median
2710523|NCT01169558|Secondary|Efficacy: Time to Disease Progression|Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.|||months||95% Confidence Interval|Median
2710524|NCT01169558|Secondary|Efficacy: Overall Survival|Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.|||months||95% Confidence Interval|Median
2710540|NCT01169467|Primary|Variability of Intracranial Pressure (ICP)|Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.|||mmHg||Standard Error|Mean
2710541|NCT01169350|Secondary|Response to Radiation Therapy (XRT) by RECIST Criteria|Will be approached using multivariate logistic regression.|Up to 2 years|Study ended. No patients were assessed for response to radiation therapy (XRT) by RECIST criteria. No data were collected for this assessment.||||||
2710525|NCT01169558|Primary|Safety: Number of Participants With Serious and Specific Adverse Events|A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.|Up to approximately 3 years|The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.|||participants|||Number
2710526|NCT01169519|Secondary|Hemodynamic Safety and Efficacy|Assessment of pulmonary vascular resistance|10 minutes after completion of sildenafil infusion||||Wood units * m^2||Inter-Quartile Range|Median
2710527|NCT01169519|Primary|Maximum Sildenafil Plasma Concentration|Assessment of peak sildenafil plasma concentration.|5 minutes after completion of sildenafil infusion|3 patients were enrolled in this group but in 1 participant, an inadequate plasma sample volume prevented accurate determination of sildenafil concentration.|||ng/mL||Standard Deviation|Mean
2710528|NCT01169493|Secondary|Left Ventricular End-diastolic Size||6 months|Data not collected.|||cubic cm||Standard Error|Mean
2710529|NCT01169493|Secondary|Left Ventricular Ejection Fraction (LVEF)||6 months|Data not collected.|||percent||Standard Deviation|Mean
2710530|NCT01169493|Secondary|NYHA Function Class|The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.|6 months||||units on a scale||Standard Deviation|Mean
2710531|NCT01169493|Secondary|6-minute Walk Distance|6-minute walk distance was the distance that a participant could walk in 6 minutes.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||meters||Standard Deviation|Mean
2710532|NCT01169493|Secondary|Minnesota Quality of Life Questionnaire|This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||units on a scale||Standard Deviation|Mean
2710533|NCT01169493|Secondary|Arrhythmic Events|To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||participants|||Number
2710534|NCT01169493|Secondary|Secondary Echocardiographic Endpoints|Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.|6 months|Data not collected.||||||
2710535|NCT01169493|Primary|The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.||6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||percentage of participants|||Number
2710536|NCT01169467|Secondary|Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury|Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.|Baseline to 24 hours|Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis.|||mmHg||Standard Error|Mean
2710537|NCT01169467|Secondary|Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury|Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.|||mmHg||Standard Error|Mean
2710538|NCT01169467|Secondary|Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury|Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.|24 hours|Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis.|||mg/ml||Standard Error|Mean
2710539|NCT01169467|Primary|Change in Pressure Reactivity Index (PRx)|"Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).~A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP."|Baseline to 24 hours|Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis.|||Pressure Reactivity Index||Standard Error|Mean
2710546|NCT01169311|Secondary|Quality of Life, Physical Component|Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation|baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.|||units on a scale||Standard Deviation|Mean
2710547|NCT01169311|Secondary|Post Operative Pain|Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain|baseline, 30 days post op||||units on a scale||Standard Deviation|Mean
2710548|NCT01169311|Secondary|Incidence of Stapler Malfunction or Misfires||about 20 minutes for procedure||||participants|||Number
2710549|NCT01169311|Secondary|Time to Return to Normal Activity||30 days post op||||Days||Standard Deviation|Mean
2710550|NCT01169311|Secondary|Length of Stay|length of time between time of admission and time of discharge|Day 0, time of discharge minus time of admission||||Minutes||Standard Deviation|Mean
2710551|NCT01169311|Secondary|Intra-Operative Bleeding Requiring Intervention|Incidence of intervention for intra-operative staple-line bleeding|Day 0 - time of surgery||||participants|||Number
2710552|NCT01169311|Secondary|OR Time|Duration of procedure|Day 0 - Time of stop minus time of start||||minutes||Standard Deviation|Mean
2710553|NCT01169311|Primary|Uneventful Creation of a Functional Staple Line at First Firing of Device|Successful creation of staple line at first firing of device during hemorrhoidopexy|about 20 minutes for procedure||||participants|||Number
2710554|NCT01169259|Other Pre-specified|Number of Participants With Colorectal Adenoma|Colorectal adenoma|5 years||2020-11-30|11/2020||||
2710555|NCT01169259|Other Pre-specified|Number of Participants With Myocardial Infarction, Excluding First 2 Years of Follow-up|Myocardial infarction, excluding first 2 years of follow-up|5 years, excluding first 2 years of follow-up||||Participants|||Count of Participants
2710556|NCT01169259|Other Pre-specified|Number of Participants Who Died From Stroke|Death from stroke|5 years||||Participants|||Count of Participants
2710557|NCT01169259|Other Pre-specified|Number of Participants Who Died From Coronary Heart Disease|Death from coronary heart disease|5 years||||Participants|||Count of Participants
2710558|NCT01169259|Other Pre-specified|Number of Participants Who Died From Myocardial Infarction|Death from myocardial infarction|5 years||||Participants|||Count of Participants
2710559|NCT01169259|Other Pre-specified|Number of Participants With Hemorrhagic Stroke|Hemorrhagic stroke|5 years||||Participants|||Count of Participants
2710560|NCT01169259|Other Pre-specified|Number of Participants With Ischemic Stroke|Ischemic stroke|5 years||||Participants|||Count of Participants
2710561|NCT01169259|Other Pre-specified|Number of Participants With Total Coronary Heart Disease|Total coronary heart disease = a composite of myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary-artery bypass grafting), and death from coronary heart disease|5 years||||Participants|||Count of Participants
2710562|NCT01169259|Other Pre-specified|Number of Participants With Coronary-artery Bypass Grafting|Coronary-artery bypass grafting|5 years||||Participants|||Count of Participants
2710563|NCT01169259|Other Pre-specified|Number of Participants With Percutaneous Coronary Intervention|Percutaneous coronary intervention|5 years||||Participants|||Count of Participants
2710564|NCT01169259|Other Pre-specified|Number of Participants Who Died From Any Cause, Excluding First 2 Years of Follow-up|Death from any cause, excluding first 2 years of follow-up|5 years, excluding first 2 years of follow-up||||Participants|||Count of Participants
2710565|NCT01169259|Other Pre-specified|Number of Participants Who Died From Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up|Death from invasive cancer of any type, excluding first 2 years of follow-up|5 years, excluding first 2 years of follow-up||||Participants|||Count of Participants
2710566|NCT01169259|Secondary|Number of Participants With a Major Cardiovascular Event, Excluding First 2 Years of Follow-up|Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes; excluding first 2 years of follow-up|5 years, excluding first 2 years of follow-up||||Participants|||Count of Participants
2710567|NCT01169259|Secondary|Number of Participants With Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up|Invasive cancer of any type, excluding first 2 years of follow-up|5 years, excluding first 2 years of follow-up||||Participants|||Count of Participants
2710568|NCT01169259|Secondary|Number of Participants Who Died From Any Cause|Death from any cause|5 years||||Participants|||Count of Participants
2710569|NCT01169259|Secondary|Number of Participants Who Died From Cardiovascular Causes|Death from cardiovascular causes|5 years||||Participants|||Count of Participants
2710570|NCT01169259|Secondary|Number of Participants With Stroke|Stroke|5 years||||Participants|||Count of Participants
2710571|NCT01169259|Secondary|Number of Participants With Myocardial Infarction|Myocardial infarction|5 years||||Participants|||Count of Participants
2710572|NCT01169259|Secondary|Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint|Expanded composite cardiovascular endpoint = a composite endpoint of myocardial infarction, stroke, death from cardiovascular causes, and coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)|5 years||||Participants|||Count of Participants
2710573|NCT01169259|Secondary|Number of Participants With Colorectal Cancer|Colorectal cancer|5 years||||Participants|||Count of Participants
2710574|NCT01169259|Secondary|Number of Male Participants With Prostate Cancer|Prostate cancer (in men)|5 years||||Participants|||Count of Participants
2710575|NCT01169259|Secondary|Number of Female Participants With Breast Cancer|Breast cancer (in women)|5 years||||Participants|||Count of Participants
2710576|NCT01169259|Secondary|Number of Participants Who Died From Invasive Cancer of Any Type|Death from invasive cancer of any type|5 years||||Participants|||Count of Participants
2710577|NCT01169259|Primary|Number of Participants With a Major Cardiovascular Event|Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes|5 years||||Participants|||Count of Participants
2710582|NCT01169103|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score|Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5]|Baseline and 6 months||||HOMA-IR score||Standard Deviation|Mean
2710583|NCT01169103|Primary|Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months|Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)|Baseline and 6 months|Due to scheduling difficulties one no treatment subject did not perform the MRI portion of the study at either the baseline or the 6 month visit.|||mm^2||Standard Deviation|Mean
2710584|NCT01169064|Secondary|Patient Dressing Cost|Total cost of dressings per group based on 1 dressing per patient|Postoperative||||dollars|||Number
2710585|NCT01169064|Secondary|Infection Rate Adjusted for Maternal BMI||6 weeks postpartum||||percentage of participants||95% Confidence Interval|Number
2710586|NCT01169064|Primary|Silver Treatment Efficacy|As measured by number of patients with postop infections at 6 wks|6 weeks postpartum||||participants|||Number
2710587|NCT01169038|Primary|Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.|The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.|8 weeks|In the ITT analysis, we included the values from the last measured value for those who did not complete the trial. We analyzed the measured value at 8 weeks among those subjects who completed 8 weeks of therapy in the per protocol analysis.|||liters||Standard Deviation|Mean
2710588|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion|Low back left sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
2710589|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion|Low back right sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
2710590|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Extension Range of Motion|Low back extension range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
2710591|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion|Low back flexion range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
2710592|NCT01168999|Primary|Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale|"Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating no pain at all and 100 mm indicating the worst pain imaginable."|baseline and immediately following their assigned intervention during the initial session||||units on a scale||Standard Deviation|Mean
2710593|NCT01168999|Primary|Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index|The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.|Change from Baseline at 2 weeks||||units on a scale||Standard Deviation|Mean
2710594|NCT01168999|Primary|Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale|A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain|Change from Baseline at 2 weeks||||units on a scale||Standard Deviation|Mean
2710595|NCT01168999|Primary|Expectation for Treatment Effectiveness|how helpful participants expect the assigned intervention will be in decreasing their low back pain|baseline||||percent expecting less pain|||Number
2710596|NCT01168999|Primary|Believability of Placebo|Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT|baseline||||percentage of participants|||Number
2710597|NCT01168986|Secondary|Change From Baseline in Neck Extension Range of Motion at 2 Weeks|change in neck extension range of motion over a 2 week period|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||degrees||Standard Deviation|Mean
2710598|NCT01168986|Primary|Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale|Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.|Immediate within session change pre to post intervention|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||units on a scale||Standard Deviation|Mean
2710599|NCT01168986|Primary|2 Week Change in Disability on the Neck Disability Index|A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||2 week change in units a scale||Standard Deviation|Mean
2710600|NCT01168986|Primary|2 Week Change in Pain Score on a Numeric Rating Scale|a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||units on a scale||Standard Deviation|Mean
2710601|NCT01168973|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died|Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received.|||participants|||Number
2710602|NCT01168973|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.|Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants who received any quantity of study treatment, grouped by the treatment they actually received, who had a baseline and at least 1 post-baseline ADA assessment.|||participants|||Number
2710603|NCT01168973|Secondary|Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab||Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)|Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2710604|NCT01168973|Secondary|Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores|The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment.|||units on a scale||Standard Deviation|Mean
2710605|NCT01168973|Secondary|Maximum Improvement on Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score.|||mm||Standard Deviation|Mean
2710606|NCT01168973|Secondary|Percentage of Participants Achieving Disease Control (Disease Control Rate)|Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.|||percentage of participants||95% Confidence Interval|Number
2710607|NCT01168973|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.|||percentage of participants||95% Confidence Interval|Number
2710633|NCT01168908|Primary|Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging.|To determine whether a 6 month trial of oral sildenafil compared to placebo improves cardiac contractile function in DBMD as determined by a > 10% decline in end-systolic volume as detected by CMR.|6 months compared to baseline||||ml||Standard Deviation|Mean
2710608|NCT01168973|Secondary|Progression-Free Survival (PFS) Time|PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Randomization to measured PD or date of death from any cause (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants.|||months||95% Confidence Interval|Median
2710609|NCT01168973|Primary|Overall Survival|Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Randomization to date of death from any cause (up to 34 months)|Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 200 participants; placebo and docetaxel arm = 169 participants.|||months||95% Confidence Interval|Median
2710610|NCT01168934|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2710611|NCT01168934|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) (MRAUC [0-∞]).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Ratio||Standard Deviation|Geometric Mean
2710612|NCT01168934|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2710613|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2710614|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2710615|NCT01168934|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||ng*hr/mL||Standard Deviation|Geometric Mean
2710616|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2710617|NCT01168934|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
2710714|NCT01168427|Secondary|R-wave Amplitude Measurement|Average R-wave amplitude at implant and 30-days post procedure|Implant procedure and 30 days post-implant procedure|||||||
2710618|NCT01168934|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
2710619|NCT01168934|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2710620|NCT01168934|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2710621|NCT01168934|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2710622|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2710623|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2710624|NCT01168934|Secondary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])|AUClast[dn] = Dose normalized area under the plasma concentration time-curve (AUC[dn]) from zero to the last measured concentration.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL/mg||Standard Deviation|Geometric Mean
2710625|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2710626|NCT01168934|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2710627|NCT01168934|Primary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])|AUC [0 - ∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL/mg||Standard Deviation|Geometric Mean
2710628|NCT01168908|Secondary|Ejection Fraction|Left ventricular ejection fraction by cardiac MRI was measured|6 months||||percentage of volume||Standard Deviation|Mean
2710629|NCT01168908|Secondary|Change in Skeletal Muscle Strength|Skeletal muscle strength will be assessed by pincher and grip dynamometry|6 months and 12 months||||pounds||Standard Deviation|Mean
2710630|NCT01168908|Secondary|Change in Forced Vital Capacity (FVC) by Pulmonary Function Testing|Skeletal muscle function of the diaphragm will be measured using FVC by pulmonary function testing.|6 months and 12 months||||liters||Standard Deviation|Mean
2710631|NCT01168908|Secondary|Change in Cardiac Mass|Left ventricular (LV) mass will be measured by CMR .|6 months and 12 months||||grams||Standard Deviation|Mean
2710632|NCT01168908|Secondary|Change in Cardiac Systolic and Diastolic Function by CMR|Cardiac volumes and systolic ejection parameters will be measured.|6 months and 12 months||||ml||Standard Deviation|Mean
2710715|NCT01168427|Secondary|Physician Satisfaction With Reveal In-office Implants|Observational survey of physicians satisfaction post implant At implant|At implant|||||||
2710634|NCT01168856|Primary|Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688|Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.|Month 18|Resistance monitoring population.|||participants|||Number
2710635|NCT01168856|Primary|Number of Participants With STV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.~Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.~Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.|||participants|||Number
2710636|NCT01168856|Primary|Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.|||participants|||Number
2710637|NCT01168856|Primary|Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population.|||participants|||Number
2710638|NCT01168856|Primary|Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.|||participants|||Number
2710639|NCT01168856|Primary|Number of Participants With DNV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study."|Month 3-18|Resistance monitoring population.|||participants|||Number
2710640|NCT01168856|Primary|Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.~Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.|||participants|||Number
2710641|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.|||Beats per minute||Standard Deviation|Mean
2710642|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.|||Beats per minute||Standard Deviation|Mean
2710643|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.|||Beats per minute||Standard Deviation|Mean
2710644|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.|||Beats per minute||Standard Deviation|Mean
2710645|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.|||mmHg||Standard Deviation|Mean
2710646|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.|||mmHg||Standard Deviation|Mean
2710647|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.|||mmHg||Standard Deviation|Mean
2710648|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.|||mmHg||Standard Deviation|Mean
2710649|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.|||mmHg||Standard Deviation|Mean
2710650|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.|||mmHg||Standard Deviation|Mean
2710651|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.|||mmHg||Standard Deviation|Mean
2710652|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.|||mmHg||Standard Deviation|Mean
2710653|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.||||||
2710654|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.||||||
2710655|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.||||||
2710656|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.|||IU/mL||Standard Deviation|Mean
2710657|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.|||Percentage of participants|||Number
2710658|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.|||Percentage of participants|||Number
2710659|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.|||Percentage of participants|||Number
2710660|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.|||Percentage of participants|||Number
2710661|NCT01168856|Primary|Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm|Percentage of participants who received any anti-HCV medication during the monitoring period was reported.|Up to 18 months|Resistance monitoring population.|||Percentage of participants|||Number
2710716|NCT01168427|Secondary|Techniques and Procedures Utilized During Reveal In-office Implants|Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.|At implant|||||||
2710662|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 18|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.|||Beats per minute||Standard Deviation|Mean
2710663|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.|||Beats per minute||Standard Deviation|Mean
2710664|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 9|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.|||Beats per minute||Standard Deviation|Mean
2710665|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.|||Beats per minute||Standard Deviation|Mean
2710666|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 3|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.|||Beats per minute||Standard Deviation|Mean
2710667|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.|||mmHg||Standard Deviation|Mean
2710668|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.|||mmHg||Standard Deviation|Mean
2710669|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.|||mmHg||Standard Deviation|Mean
2710670|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.|||mmHg||Standard Deviation|Mean
2710671|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.|||mmHg||Standard Deviation|Mean
2710672|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.|||mmHg||Standard Deviation|Mean
2710673|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.|||mmHg||Standard Deviation|Mean
2710674|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.|||mmHg||Standard Deviation|Mean
2710675|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.|||mmHg||Standard Deviation|Mean
2710676|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.|||mmHg||Standard Deviation|Mean
2710677|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.|||IU/mL||Standard Deviation|Mean
2710678|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.|||IU/mL||Standard Deviation|Mean
2710679|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.|||IU/mL||Standard Deviation|Mean
2710680|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.|||IU/mL||Standard Deviation|Mean
2710681|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.|||IU/mL||Standard Deviation|Mean
2710682|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.|||Percentage of participants|||Number
2710683|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.|||Percentage of participants|||Number
2710684|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.|||Percentage of participants|||Number
2710685|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.|||Percentage of participants|||Number
2710686|NCT01168856|Primary|Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).|Month 3|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.|||Percentage of participants|||Number
2710687|NCT01168726|Secondary|Protective Behavioral Strategies Scale.|Use of protective behavioral strategies related to alcohol use. Higher scores indicate more use of the strategies. A total score was calculated by summing the three subscale scores on the measure (range = 3-18).|6 months||||units on a scale||Standard Deviation|Mean
2710688|NCT01168726|Secondary|Drinking Norms Rating Form|Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form. Higher values indicate that the individual perceives higher levels of drinking among other students. Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.|6 months||||units on a scale (standardized)||Standard Deviation|Mean
2710689|NCT01168726|Primary|Rutgers Alcohol Problems Index (RAPI)|Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.|6 months||||units on a scale||Standard Deviation|Mean
2710690|NCT01168726|Primary|Drinks Per Week||6 Months||||drinks per week||Standard Deviation|Mean
2710691|NCT01168687|Primary|Standard Alcoholic Drinks Per Treatment Period|The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.|This will be assessed during a 42-day period.|All study participants were used for data analysis. If there were no significant differences between the two doses of levetiracetam, data would be collapsed for analysis.|||number of drinks per treatment period||Standard Error|Mean
2710692|NCT01168674|Secondary|Predictors of Bipolarity to Define the Study Population|The specific bipolarity predictors in patients with MDD were assessed.|13 weeks|The most common predictor was antidepressant tolerance, as reported below in 37 subjects.|||percentage of subjects|||Number
2710693|NCT01168674|Primary|MADRS Improvement Over 6 Weeks|"Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods.~Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms.~Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode.~No subscales were used or combined."|13 weeks (Two 6 week periods plus a one week washout)||||units on a scale||Standard Deviation|Mean
2710694|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tense|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710695|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Happy|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710717|NCT01168427|Secondary|Surgical Staff Utilized for Reveal In-office Implants|Observational analysis of surgical staff present at the Reveal Implants|At implant|||||||
2711956|NCT01158703|Secondary|Number of Myocardial Infarction Events|Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants|||MI Events over 52Wks|||Number
2710696|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tired|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710697|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Energetic|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710698|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Angry|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710699|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Sad|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710700|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Confused|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710701|NCT01168596|Other Pre-specified|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710702|NCT01168596|Other Pre-specified|Becks Depression Inventory (BDI-II)|The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.|Change from baseline to week 12||||units on a scale||95% Confidence Interval|Mean
2710703|NCT01168596|Other Pre-specified|State-Trait Anxiety Inventory (STAI)|The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710704|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Afraid|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710705|NCT01168596|Other Pre-specified|Marin Apathy Inventory (Apathy Evaluation Scale)|The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710706|NCT01168596|Other Pre-specified|Parkinson's Disease Sleep Scale (PDSS)|The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710707|NCT01168596|Secondary|Hand-grip Strength|The patients use the hand on the side most affected by Parkinson's disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||seconds||95% Confidence Interval|Mean
2710708|NCT01168596|Secondary|Finger Tapping|The patient is asked to use the index finger on the side most affected by Parkinson's disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||finger taps per sixty seconds||95% Confidence Interval|Mean
2710709|NCT01168596|Secondary|Paced Auditory Serial Addition Test (PASAT)|The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710710|NCT01168596|Secondary|PD Quality of Life Scale (PDQ39)|PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710711|NCT01168596|Secondary|Multidimensional Fatigue Inventory (MFIS)|The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710712|NCT01168596|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710713|NCT01168596|Primary|Modified Fatigue Impact Scale (MFIS)|The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
2710718|NCT01168427|Secondary|Number of Participants Having Procedure-related Adverse Events|Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).|From Implant to 90 days post-implant procedure||||participants|||Number
2710719|NCT01168427|Primary|Procedure-related Complications Rate Requiring Resolution by Surgical Intervention|This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.|From Implant to 90 days post-implant procedure|Reveal device indicated patients, enrolled in the study and implanted per protocol|||participants|||Number
2710720|NCT01168401|Secondary|Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA|Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||percentage of participants||95% Confidence Interval|Number
2710721|NCT01168401|Secondary|GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline|GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||fold rise||95% Confidence Interval|Geometric Mean
2710722|NCT01168401|Secondary|GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)|GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393)|PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||titer||95% Confidence Interval|Geometric Mean
2710723|NCT01168401|Secondary|Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgM|Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).||||||
2710724|NCT01168401|Secondary|Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG|Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||percentage of participants||95% Confidence Interval|Number
2710725|NCT01168401|Secondary|Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA|Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||percentage of participants||95% Confidence Interval|Number
2710726|NCT01168401|Secondary|GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgM as Compared to Baseline|Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).||||||
2710727|NCT01168401|Secondary|GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline|Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||fold rise||95% Confidence Interval|Geometric Mean
2710797|NCT01167881|Primary|The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.||Baseline and 104 weeks|"FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.~."|||percentage of HbA1c||Standard Error|Mean
2710728|NCT01168401|Secondary|Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline|Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)|PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||fold rise||95% Confidence Interval|Geometric Mean
2710729|NCT01168401|Secondary|GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgM|Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)|Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).||||||
2710730|NCT01168401|Secondary|GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG|Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)|PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||titer||95% Confidence Interval|Geometric Mean
2710731|NCT01168401|Secondary|Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A|Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.|First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)|Per Protocol (PP) population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.|||titer||95% Confidence Interval|Geometric Mean
2710732|NCT01168401|Primary|Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)||Baseline up to 365 Days after post dose 2 (Day 393)|mITT population included all participants who received at least 1 dose of study product.|||participants|||Number
2710733|NCT01168401|Primary|Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.|Baseline up to Day 35|mITT population included all participants who received at least 1 dose of study product.|||participants|||Number
2710734|NCT01168401|Primary|Number of Participants With Unsolicited AEs Post Dose 2||Day 28 up to Day 56 (Post dose 2)|mITT population where Day 28 to 56 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product.|||participants|||Number
2710735|NCT01168401|Primary|Number of Participants With Unsolicited AEs Post Dose 1||Baseline up to Day 28 (Pre-dose 2)|mITT population included all participants who received at least 1 dose of study product.|||participants|||Number
2710736|NCT01168401|Primary|Number of Participants With Solicited Systemic AEs Post Dose 2|Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).|Day 28 up to Day 35|mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.|||participants|||Number
2710737|NCT01168401|Primary|Number of Participants With Solicited Systemic AEs Post Dose 1|Elevated oral temperature:Mild(38-38.4 Celsius[C]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400gram[g]/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required intravenous[IV]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).|Day 0 up to Day 7|mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.|||participants|||Number
2710738|NCT01168401|Primary|Number of Participants With Solicited Local AEs Post Dose 2|The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever >24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).|Day 28 up to Day 35|mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.|||participants|||Number
2710739|NCT01168401|Primary|Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1|The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (>) 24 hours [24h] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter [cm] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).|Day 0 up to Day 7|mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.|||participants|||Number
2710740|NCT01168349|Secondary|Percentage of Participants With Vitamins Prescription||Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2710741|NCT01168349|Secondary|Percentage of Participants With Adequate Iron Status|Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2710742|NCT01168349|Secondary|Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710743|NCT01168349|Secondary|Relative Percent Change in Hb Concentration From Baseline Over the Study Period||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2710744|NCT01168349|Secondary|Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment||Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2710745|NCT01168349|Secondary|Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment|Percentage of participants with at least 1 temporary discontinuation was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710746|NCT01168349|Secondary|Percentage of Participants With Modifications of NeoRecormon® Regimen|All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710747|NCT01168349|Secondary|Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710748|NCT01168349|Secondary|Percentage of Participants With Subcutaneous (SC) Route of Administration||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2710749|NCT01168349|Secondary|Percentage of Participants With Pre-specified Dose and Frequency of Injections|Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2710750|NCT01168349|Secondary|Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks||Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710751|NCT01168349|Secondary|Mean Starting Dose of NeoRecormon® Injection|Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||IU/kg/weeks||Standard Deviation|Mean
2710752|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710809|NCT01167712|Other Pre-specified|Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product||Baseline (T0) up to 10 days after the start of course 2 (T2)|||||||
2710753|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710754|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710755|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710756|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710757|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710758|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline|Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710759|NCT01168349|Primary|Mean Number of Days of Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who had at least 1 sick leave without any missing data.|||days||Standard Deviation|Mean
2710760|NCT01168349|Primary|Percentage of Participants With At Least 1 Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710761|NCT01168349|Primary|Percentage of Participants With Professional Activity: Baseline|Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710762|NCT01168349|Primary|KPS: Week 24 to 28|KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710824|NCT01167582|Secondary|Congestive Heart Failure||30 days||||Participants|||Count of Participants
2710825|NCT01167582|Secondary|Stroke||30 days||||Participants|||Count of Participants
2710763|NCT01168349|Primary|KPS: Week 12 to 16|KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710764|NCT01168349|Primary|KPS: Week 4 to 6|KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710765|NCT01168349|Primary|Karnofsky Performance Status (KPS): Baseline|KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2710766|NCT01168349|Primary|Time to First RBC Transfusions|Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||weeks||95% Confidence Interval|Median
2710767|NCT01168349|Primary|Mean Number of RBC Units|Mean number of units was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.|||RBC units||Standard Deviation|Mean
2710768|NCT01168349|Primary|Mean Number of RBC Transfusions|Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.|||RBC transfusions||Standard Deviation|Mean
2710769|NCT01168349|Primary|Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion|Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2710770|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 21 to 42|Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Day 21 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
2710771|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 28 to 42|Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.|Day 28 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
2710772|NCT01168232|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2710773|NCT01168232|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2710774|NCT01168232|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period.|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0|During treatment and up to 30 days after stopping the study treatment|Eligible and Treated Participants|||participants|||Number
2710775|NCT01168232|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days|Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval|||percentage||95% Confidence Interval|Number
2710776|NCT01168219|Secondary|100-day Mortality|The number of death reported within the first 100 days after transplant.|Up to 100 days post-treatment|Patients who received transplant and died are included in this analysis.|||Participants|||Count of Participants
2710777|NCT01168219|Secondary|Overall Survival (OS)|Overall survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are still alive 2 and 5 years after date of transplantation respectively. Estimated using the Kaplan-Meier product limit estimator.|Up to 5 years|Patients who received transplant were evaluable for this endpoint.|||percentage of patients||95% Confidence Interval|Number
2710798|NCT01167881|Secondary|The Change in Body Weight From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||kilograms||Standard Error|Mean
2710778|NCT01168219|Primary|Progression-free Survival|"Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively.~AML progression is defined as:~Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow~If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts~Development of extramedullary leukemia MDS progression is defined as~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts~Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate"|Up to 5 years|Patients who received transplant were evaluable for the primary endpoint.|||percentage of patients||80% Confidence Interval|Number
2710779|NCT01168024|Secondary|Change in Kidney Function Between the Randomized Groups.||Up to 96 hours post-procedure|Change in eGFR was available for 2 treatment and 1 control subject. 1 out of range eGFR value for a subject (0.1) was not used as this value is not clinically feasible.|||mL/min/1.73m^2||Standard Deviation|Mean
2710780|NCT01168024|Primary|Evaluating Local Events.|"Events evaluated include:~Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death~Pericardial effusions (including pericardial tamponade) requiring treatment"|Through 30 days post-procedure.||||events|||Number
2710781|NCT01168024|Primary|Evaluating Bleeding/Transfusion Events.|"Bleeding/transfusion events evaluated:~Blood loss requiring transfusion of ≥ 2 units~Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding~TIMI Minor Bleeding"|Through 30 days post-procedure||||events|||Number
2710782|NCT01168024|Primary|Incidence of Contrast Induced Nephropathy (CIN) in Subjects.|CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).|Through 72 hours post-procedure||||participants|||Number
2710783|NCT01167907|Secondary|Reduction of Quadriceps Strength|"Secondary endpoints of reduction of quadriceps strength will be evaluated. To determine the effect of saphenous block on quadriceps function, patients will have knee extension muscle strength using a Hoggan Health microFET 2 MT Digital Handheld Dynamometer.~Knee Extension: Measuring knee extension was performed with the digital dynamometer placed on the anterior surface of the lower leg proximal to the ankle."|24 hours post nerve blockade||||pounds||Standard Deviation|Mean
2710784|NCT01167907|Secondary|Sleep Disturbance|Secondary endpoints of reduction of sleep disturbance (as number of awakenings) will be evaluated.|48 hours post nerve blockade||||awakenings||Standard Deviation|Mean
2710785|NCT01167907|Secondary|Vomiting|Secondary endpoints of reduction of vomiting will be evaluated.|48 hour post nerve blockade||||Participants|||Count of Participants
2710786|NCT01167907|Secondary|Nausea|Secondary endpoints of reduction of nausea will be evaluated.|48 hours post nerve blockade||||Participants|||Count of Participants
2710787|NCT01167907|Secondary|Opioid Use|"Secondary endpoints of reduction of opioid use will be evaluated.~Outcome will be measured using 24h mg-equivalent oxycodone consumption. - (Units in mg/24h)"|48 hours post nerve blockade||||mg per 24h||Standard Deviation|Mean
2710788|NCT01167907|Primary|Verbal Pain Scores|"The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved.~Verbal Pain Score is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate no pain and is the best score Ten (10) is used to rate the worst pain imaginable and is the worst score"|48 hours post nerve blockade||||units on a scale||Standard Deviation|Mean
2710789|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
2710790|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
2710791|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.||baseline and 52 weeks|Treated set, all patients treated with at least one dose of randomised study drug.|||participants|||Number
2710792|NCT01167881|Secondary|The Change in Body Weight From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||kilograms||Standard Error|Mean
2710793|NCT01167881|Secondary|The Change From Baseline in HbA1c After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
2710794|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
2710795|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|"FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.~."|||mmHg||Standard Error|Mean
2710796|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.||baseline and 104 weeks|Treated set, all patients treated with at least one dose of randomised study drug.|||participants|||Number
2710810|NCT01167712|Secondary|Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)|Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)|18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks|All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.|||Units on a Scale||Standard Error|Mean
2710811|NCT01167712|Secondary|Median Duration of First Quartile Survival|First Quartile Overall Survival|The timeframe is from enrollment onto the study up to 3 years after enrollment|Whole sample|||months||95% Confidence Interval|Median
2710812|NCT01167712|Primary|Progression-Free Survival|First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The timeframe is from enrollment onto the study up to 3 years following enrollment.|Whole sample|||months||95% Confidence Interval|Median
2710813|NCT01167634|Primary|Change in Weight|Change in weight between baseline and 24 weeks|24 Weeks||||pounds||Standard Deviation|Mean
2710814|NCT01167608|Primary|"3rd Most Commonly Reported Future Barrier to Mental Health Services: Services Are Not Available in my Community"|The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.|Baseline|This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures.|||percentage of total respondents|||Number
2710815|NCT01167608|Primary|"2nd Most Commonly Reported Future Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most commonly reported future barrier to mental health services reported by those who responded to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.|Baseline|This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures.|||percentage of total respondents|||Number
2710816|NCT01167608|Primary|"Most Commonly Reported Future Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.|Baseline|This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures.|||percentage of total respondents|||Number
2710817|NCT01167608|Primary|"3rd Most Commonly Reported Past Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited access.|Baseline|This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures.|||percentage of total respondents|||Number
2710818|NCT01167608|Primary|"2nd Most Commonly Reported Past Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.|Baseline|This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures.|||percentage of total respondents|||Number
2710819|NCT01167608|Primary|"Most Commonly Reported Past Barrier to Mental Health Services: Anyone in my Situation Would be Struggling"|The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as low mental health literacy.|Baseline|This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures.|||percentage of total respondents|||Number
2710820|NCT01167582|Secondary|Composite Mortality and Morbidity|Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization or pneumonia.|30 days||||Participants|||Count of Participants
2710821|NCT01167582|Secondary|Pneumonia or Blood Stream Infection and Each Separately||30 days||||Participants|||Count of Participants
2710822|NCT01167582|Secondary|Deep Vein Thrombosis or Pulmonary Embolism||30 days||||Participants|||Count of Participants
2710823|NCT01167582|Secondary|Stent Thrombosis||30 days||||Participants|||Count of Participants
2710829|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months.|6 months||||Participants|||Count of Participants
2710830|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days.|30 days||||Participants|||Count of Participants
2710831|NCT01167582|Primary|Red Blood Cell Transfusion|Differences in mean number of units of red blood cell transfusions between the two study arms.|In-hospital up to 30 days post randomization||||blood units||Standard Deviation|Mean
2710832|NCT01167582|Primary|Hemoglobin Concentration|Differences in the mean hemoglobin concentrations between the two study arms.|In-hospital up to 30 days post randomization||||g/dL||Standard Deviation|Mean
2710833|NCT01167504|Secondary|Defined Behaviour of Salivary Film Formation|"A secondary output is a well defined description of the film formation behaviour of normalsaliva in terms of thickness (nm), viscoelastic modulus (mN/m) and temporal behaviour. This will be used to develop model or artificial salivas saliva that forms films in the same way as real saliva ex vivo, that can be used to screen the effects of different compounds and ingredients, without having to collect fresh saliva from human volunteers. The measure is the rate of increase in film thickness (depth, nm) as a function of time, measured by adsorbing whole mouth saliva onto a solid silica surface and measuring the film thickness using Dual Polarisation Interferometry and Quartz Crystal Microbalance."|Within 4 hours of saliva collection.|Literature data and power calculations were used to calculate the number of individuals required to show a statistical significant effect of the presence of ingredients on the thickness of the salivary film.|||nm/cm2/min||Standard Deviation|Mean
2710834|NCT01167504|Primary|Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces|The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm^2), density (ng/cm^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.|Within 4 hours of saliva collection.|Based on published results of saliva pellicle thickness, power calculations showed that 12 individuals would provide sufficient statistical significance to determine the effect of added ingredients on salivary film thickness.|||nm||Standard Deviation|Mean
2710835|NCT01167452|Primary|Elimination Rate Constants for Sulfamethoxazole and Trimethoprim||24 hours||||hr-1||Full Range|Median
2710836|NCT01167426|Secondary|Patient Injection Experience Preference|"The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. strongly prefer first experience (first 2 weeks); 2. somewhat prefer first experience (first 2 weeks); 3. no preference; 4. somewhat prefer second experience (past 2 weeks); 5. strongly prefer second experience (past 2 weeks). Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience)."|Week 4|Analysis Population with available data.|||participants|||Number
2710837|NCT01167426|Primary|Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience|"The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from strongly disagree (score = 1) to strongly agree (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience."|Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).|The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks.|||units on a scale||Standard Deviation|Mean
2710838|NCT01167257|Secondary|Net Change of the Global Response Assessment (GRA)|Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.|Baseline to 4 weeks after initial treatment||||participants|||Number
2710839|NCT01167257|Secondary|Net Change of the Urgency Severity Score (USS) Within 3 Days|Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days. The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.|Baseline to 4 weeks after initial treatment||||participants|||Number
2710840|NCT01167257|Secondary|Net Change of the Postvoid Residual Volume (PVR)|Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value|Baseline and 1 month after initial treatment||||mL||Inter-Quartile Range|Median
2710841|NCT01167257|Secondary|Net Change of the Maximum Flow Rate (Qmax)|Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||mL/s||Inter-Quartile Range|Median
2710842|NCT01167257|Secondary|Net Change of the Functional Bladder Capacity (FBC)|Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||mL||Inter-Quartile Range|Median
2710843|NCT01167257|Secondary|Net Change of the Overactive Bladder Symptom Score (OABSS)|"Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively.~The OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment||||units on a scale||Inter-Quartile Range|Median
2710844|NCT01167257|Secondary|Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days|"Efficacy:~Mean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||Frequency per 3 days||95% Confidence Interval|Median
2710845|NCT01167257|Secondary|Mean Change of the Urgency Episodes Per 3 Days|"Efficacy:~Mean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||Frequency per 3 days||95% Confidence Interval|Median
2710846|NCT01167257|Primary|Mean Change of the Total Frequency Per 3 Days|"Efficacy:~Mean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||Frequency per 3 days||95% Confidence Interval|Mean
2710847|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response||Up to 15 months from time of registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.||||||
2710848|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
2710849|NCT01167192|Secondary|Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
2710850|NCT01167192|Secondary|Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
2710851|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice.||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
2710852|NCT01167192|Secondary|Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events||30 days post surgery (approximately 16-20 weeks after start of registration)||||adverse event|||Number
2710853|NCT01167192|Secondary|Overall Survival Rate||Median follow-up was 59.9 months|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These 2 patients are not included in this outcome measure.|||percentage of participants|||Number
2710854|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow||Up to 15 months from registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.||||||
2710855|NCT01167192|Secondary|Number of Participants With Surgical Complications||30 days post surgery (approximately 16-20 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These two patients are not included in this outcome measure.|||participant|||Number
2710856|NCT01167192|Secondary|Time to Disease Progression|Progression = at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, unequivocal progression of existing non-target lesions.|Up to 5 years from registration|There are 8 participants not included in this outcome measure and the reasons are as follows: (1) removed from study due to treatment related toxicity prior to surgery, (1) expired prior to surgery, and (6) did not have progressive disease.|||months||Full Range|Median
2710857|NCT01167192|Primary|Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms||Prior to surgery (approximately 12-16 weeks from registration)|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.||||||
2710858|NCT01167192|Primary|Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR)|"Complete response (CR) = disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Prior to surgery (approximately 12-16 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to efficacy evaluation and 1 patient expired prior to efficacy evaluation. These two patients are not included in this outcome measure.|||Participants|||Count of Participants
2710881|NCT01166958|Secondary|Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months|One-third radius BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.||||g/cm2||Full Range|Mean
2710882|NCT01166958|Secondary|Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months|Hip BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.||||g/cm2||Full Range|Mean
2710859|NCT01167179|Primary|Psychosocial Adjustment to Illness-Scale|The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation.|baseline, 6 mo, 12mo|ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted|||units on a scale||Standard Deviation|Mean
2710860|NCT01167179|Secondary|Quality of Life|Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms.|baseline, 6 mo, 12 mo|ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted|||units on a scale||Standard Deviation|Mean
2710861|NCT01167153|Secondary|Change From Baseline in Orthostatic Pulse at 12 Weeks|Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline.|||beats/min||Standard Deviation|Mean
2710862|NCT01167153|Secondary|Change From Baseline in Sitting Pulse at 12 Weeks|Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline.|||beats/min||Standard Deviation|Mean
2710863|NCT01167153|Secondary|Change From Baseline in Orthostatic SBP and DBP at 12 Weeks|The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline.|||mm Hg||Standard Deviation|Mean
2710864|NCT01167153|Secondary|Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks|Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.|12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline|||Percentage of participants|||Number
2710865|NCT01167153|Secondary|Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)|"Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.~Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline."|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline.|||Percentage of participants|||Number
2710866|NCT01167153|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.|||mm Hg||Standard Deviation|Mean
2710867|NCT01167153|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.|||mm Hg||Standard Deviation|Mean
2710868|NCT01167140|Secondary|Participants With an Improvement in Global Appearance|• Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline|Up to 4 months|5 subjects were excluded from effectiveness analysis because they received a lower dose.|||participants|||Number
2710869|NCT01167140|Secondary|Participants With One Point Improvement in Line Severity|• Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline|Baseline and up to 4 months|Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure.|||participants|||Number
2710870|NCT01167140|Primary|Number of Participants With Effectiveness and Safety Success|"Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale~Safety success: the absence of a device-related serious adverse event (DSAE)"|Up to 4 months|All subjects treated were analyzed to the safety endpoint.|||participants|||Number
2711957|NCT01158703|Secondary|Number of Angina Events|Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants|||Angina Events over 52Wks|||Number
2710871|NCT01167023|Secondary|P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days|PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. The VN P2Y12 assay is a point-of-care device that measures platelet aggregation with single-use, disposable cartridges. A low PRU reflects stronger inhibition of P2Y12, whereas a high PRU reflects weaker inhibition of P2Y12. The Least Squares Mean values were calculated from a mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRU measurements and a non-missing genotype.|||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
2710872|NCT01167023|Secondary|Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded intensity of pain due to SCD each day in daily pain diaries using a pain scale. A scale of 0 to 9 was used, with 0=no pain and 9=unbearable pain. A response range of 1 to 9 indicated participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. Pain intensity was the average of a participant's pain ratings. Average pain intensity=(Sum of all nonmissing pain intensity responses/number of daily pain diaries completed). Number of daily pain diaries completed is number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who had recorded the pain intensity in at least 1 daily pain diary.|||units on a scale||Standard Deviation|Mean
2710873|NCT01167023|Secondary|Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days|PRI was calculated by VASP phosphorylation assay using flow cytometry. The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12. The Least Squares (LS) Mean values were calculated from a mixed-effects model repeated measures (MMRM) analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRI measurements and a non-missing genotype.|||percentage of PRI||Standard Error|Least Squares Mean
2710874|NCT01167023|Secondary|Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration|Pain requiring medical attention was defined 2 ways: (1) if the participant attended an unplanned doctor's appointment or clinic visit, visited the emergency room, or was admitted to hospital due to sickle cell pain, or (2) if the participant experienced a vaso-occlusive crisis (VOC), acute chest syndrome, or hepatic sequestration at least once during the treatment period.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who completed at least 1 page of the daily pain diary or with pain endpoint case report form (CRF) data available.|||percentage of participants|||Number
2710875|NCT01167023|Secondary|Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded the intensity of pain due to SCD each day in the daily pain diaries. A scale of 0 to 9 was used, with 0 indicating no pain, and 9 indicating unbearable pain. A response range of 1 to 9 indicated the participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. The percentage of days with pain (pain rate) was calculated as follows: Pain rate = 100*(Total number of days with pain/number of daily pain diaries completed). Number of daily pain diaries completed was number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who recorded pain intensity in at least 1 daily pain diary.|||percentage of days||Standard Deviation|Mean
2710876|NCT01167023|Secondary|Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration|TEAEs were defined as AEs that occurred or worsened after receiving the study drug.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.|||percentage of participants|||Number
2710877|NCT01167023|Primary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration|A hemorrhagic event requiring medical intervention. Medical intervention was defined as any medical attention resulting in therapy or further investigation during the 30-day treatment duration.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.|||percentage of participants|||Number
2710878|NCT01166997|Primary|Major Bleeding and Intracranial Bleeding at 30 Days.|Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.|30 days||||participants|||Number
2710879|NCT01166997|Primary|Reduction of RV/LV Ratio|Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.|24 hours||||Ratio||Standard Deviation|Mean
2710880|NCT01166971|Primary|Defocus Curve|"A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution."|3 months after surgery|In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.|||LogMAR||Standard Deviation|Mean
2711759|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36||||percentage of participants|||Number
2710883|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum P1NP)|Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.||||mcg/L||Full Range|Mean
2710884|NCT01166958|Secondary|Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months|Spine BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.||||g/cm2||Full Range|Mean
2710885|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum CTX)|Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.||||ng/mL||Full Range|Mean
2710886|NCT01166945|Secondary|Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline|Percentage of participants with antibiotic resistant flora on day 30 compared to baseline|Baseline and 30 days|Number of participants at baseline differed from the number of participants at Day 30 as they were lost to follow up|||Participants|||Count of Participants
2710887|NCT01166945|Primary|Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)|Results are based on a daily 6-item symptom survey (day 1 to 14); a daily 3-item survey (day 15 to 30). If a particular symptom is present initially, a score of 2 is given; if it is absent the score is 0. A maximum entry score is 20 (persistent symptoms). If a particular symptom becomes more severe, less severe, or stays the same during treatment, +1, -1, or 0 respectively, will be added to the original score for each symptom. At 10 (and 20 days, respectively), children will be classified as cured, improved or failed based on survey results. Children will be considered cured if they reach a score of < 2. Children will be classified as improved if their score at 10 days (20 days, respectively) is at least 2 points less than their score at 5 days (15 days, respectively). Children will be considered to have failed therapy if their score worsens by + 3 between day 5 (day 15) and day 10 (day 20) or if their score at day 10 (day 20) does not meet criteria for improvement.|at 10 days and at 20 days|98 participants were enrolled, and 82 completed through day 20. Participant numbers change from day 10 to day 20 due to Group A Strep diagnosis, non-compliance, and lost to follow up over the course of the study.|||Participants|||Count of Participants
2710888|NCT01166763|Secondary|OH Vitamin D Levels in Serum|Assessment of 25(OH)D levels as a measure of circulating vitamin D.|baseline and 6 months|All subjects completing trial|||ng/ml||Standard Deviation|Mean
2710889|NCT01166763|Secondary|Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.|Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.|baseline and 6 months|All subjects completing trial.|||percentage of cells staining positive||Full Range|Median
2710890|NCT01166763|Primary|Change in Mammographic Breast Density Over Course of Study|Change in the percent of the breast area that is considered to be at higher density on mammogram.|baseline and 6 months|All subjects completing trial|||Change in percent dense breast area||Standard Deviation|Mean
2710891|NCT01166750|Secondary|Quality of Life||weekly for 12 weeks|||||||
2710892|NCT01166750|Secondary|Mood and Stress||weekly for 12 weeks|||||||
2710893|NCT01166750|Primary|Pain|Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.|weekly for 12 weeks|They were the ones still remaining at the end of the study.|||units on a scale||Standard Deviation|Mean
2710894|NCT01166724|Secondary|Change in iGFR|We will also compare the change in iGFR (as well as estimated GFR) from time of conversion to 12 and 24 months of follow up by paired t-test between groups.|12 months|Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.||||||
2710895|NCT01166724|Primary|Biopsy-derived Measures of Fibrosis|The primary analyses will compare biopsy-derived measures of fibrosis in the Tac-maintenance and SRL groups using the t-test.|12 months|Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.||||||
2710896|NCT01166659|Secondary|Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline|The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.|Baseline, Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.|||medications|eyes|Standard Deviation|Mean
2710897|NCT01166659|Secondary|Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication|Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.|Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.|||percentage of eyes|eyes||Number
2710898|NCT01166659|Primary|Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.|Baseline; Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.|||percentage of eyes|eyes||Number
2710899|NCT01166646|Secondary|"Number of Subjects Whose Signs of Psoriasis Was Designated Success"|"Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) success and failure with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period)."|Day 15|"Analysis shown is based on the number of subjects whose Signs of Psoriasis was designated Success (ITT population) at Day 15."|||participants|||Number
2710900|NCT01166646|Secondary|Changes in Disease Severity (Success)|"Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to success and failure with success defined as a grade of 1 or 0 at the end of treatment (EOT)."|Day 15|Analysis shown is based on the ITT population at Day 15.|||participants|||Number
2710901|NCT01166646|Primary|Pharmacokinetic Properties (AUC)|Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetics properties were evaluated in a subgroup of 12 adult subjects per arm.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2710902|NCT01166646|Primary|Pharmacokinetic Properties (Tmax)|Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.|||Hours||Full Range|Geometric Mean
2710903|NCT01166646|Primary|Pharmacokinetic Properties (Cmax)|Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2710904|NCT01166646|Primary|Adrenal Suppression Potential|Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.|After 1-2 weeks dose|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||participants|||Number
2710905|NCT01166568|Other Pre-specified|Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)|"All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.~NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710906|NCT01166568|Other Pre-specified|Safety Parameter Point Estimate -- Chronic Inflammation|"All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.~NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710907|NCT01166568|Other Pre-specified|Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)|"All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase > 10 mmHg) or (IOP > 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.~NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710908|NCT01166568|Other Pre-specified|Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines|"All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.~NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710909|NCT01166568|Other Pre-specified|Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines|"All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.~NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710910|NCT01166568|Other Pre-specified|Safety Parameter Point Estimate -- Anterior Segment Ischemia|All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710911|NCT01166568|Secondary|Presence of Significant Safety Events (SAEs).|"The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.~NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."|From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.|All subject eyes implanted with the PSI were included in the safety analysis. The point estimates were calculated for each of the following events at 24 months. Only the incidence of serious adverse events (SAE's) is presented here as only (1) secondary outcome is allowed.|||Primary and Fellow Eyes|Primary and Fellow Eyes||Count of Units
2710912|NCT01166568|Primary|Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines|Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.|From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.|Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.|||Primary Eyes|Primary Eyes||Count of Units
2710913|NCT01166438|Secondary|Patient Global Impression of Improvement|The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better).|3 and 6 months||||Participants|||Count of Participants
2710914|NCT01166438|Secondary|Change in PFDI-SF and PFIQ-SF Total Scores|Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings.|Baseline through 6 months|Data were available for 111 participants in the Standardized Anticholinergic Regimen group and 102 in the Botox A group.|||Changes in adjusted mean scores||Standard Error|Mean
2710915|NCT01166438|Secondary|Efficacy|Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).|6 months|Efficacy outcomes were assessed in the modified intention-to-treat population, which included all participants who underwent randomization and received a study medication and who had a baseline measure and at least one follow-up measure for the outcome. Proportions were based on data from participants who returned at least four follow-up diaries.|||Participants|||Count of Participants
2710916|NCT01166438|Secondary|Change From Baseline in Score on OABq-SF|Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group.|Baseline through 6 months||||Change from baseline in score on OABq-SF||Standard Error|Mean
2710917|NCT01166438|Primary|Change in Urge Urinary Incontinence (UUI) Episodes|Change from baseline in mean number of UUI episodes over 6 month double-blind period.|Baseline through 6 months||||Mean change in UUI episodes from baselin||Standard Error|Mean
2710918|NCT01166347|Secondary|Cause of Re-hospitalization|"Cause of Re-hospitalization while on device. The reason a participant may have been re-hospitalized was due to an adverse event, the need for an explant, or for various Other reasons."|Implant to two years|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received.|||Participants|||Count of Participants
2710919|NCT01166347|Secondary|Duration of Re-hospitalization|Duration of Re-hospitalization while on device|Implant to two years|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. Subjects who died while in the hospital or have a missing discharge date were not included.|||Days||Standard Deviation|Mean
2710920|NCT01166347|Secondary|Number of Participants Who Had a Re-hospitalization|Number of participants who had a re-hospitalization while on the device|Implant to two years|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received.|||Participants|||Count of Participants
2710921|NCT01166347|Secondary|Length of Initial Hospitalization|Length of Initial Hospitalization post implant|Implant to the end of the initial hospitalization|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. Subjects who died while in the hospital or have a missing discharge date were not included.|||Days||Standard Deviation|Mean
2710922|NCT01166347|Secondary|Change in Functional Status as Measured by 6-minute Walk|Change in functional status, as measured by 6-minute walk test.|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete the assessment or indicate Not Completed to be analyzed at both the baseline and Month 24 visits. If the subject did not complete the assessment, a value of 0 was imputed.|||Meters||Standard Deviation|Mean
2710923|NCT01166347|Secondary|Change in Functional Status Measured by New York Heart Association (NYHA) Class|"Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:~I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.~II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III)."|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.|||Participants|||Count of Participants
2710945|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 24 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710924|NCT01166347|Secondary|Health Status Change Measured by EuroQol EQ-5D (Version 3L)|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An adjustment was done on the response where the scores were normalized based on this paper: Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66.|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.|||units on a scale||Standard Deviation|Mean
2710925|NCT01166347|Secondary|Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.|||Units on a scale||Standard Deviation|Mean
2710926|NCT01166347|Secondary|Number of Participants With Device Malfunctions|"Number of Participants with device malfunctions per INTERMACS definition. Device malfunction denotes a failure of one or more of the components of the Mechanical Circulatory Support Device (MCSD) system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death. The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure.~Device failure should be classified according to which components fails as follows:~Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components).~Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber)"|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Participants|||Count of Participants
2710927|NCT01166347|Secondary|Overall Survival at 2 Years|Overall survival is the probability (expressed as a percent of 100) did not died within 2 years post implant via the Kaplan-Meier method. Participants that did not died were censored at the time of last follow-up or 2 years post implant, whichever occurred first.|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Probability|||Number
2710928|NCT01166347|Secondary|Number of Participants With Major Infections|Number of participants with major infections, per INTERMACS definition. A major infection is defined as: A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection include Localized non-device infection Percutaneous site and/or pocket infection Internal pump component, inflow or outflow tract infection Sepsis|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Participants|||Count of Participants
2710929|NCT01166347|Secondary|Number of Participants With Bleeding|"Number of participants with bleeding, per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. The event of bleeding is defined as: An episode of suspected internal or external bleeding that results in one or more of the following:~Death,~Re-operation,~Hospitalization,~Transfusion of red blood cells as follows:~During first 7 days post implant~Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant.~After 7 days post implant~Any transfusion of packed red blood cells (PRBC) after 7 days following implant."|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Participants|||Count of Participants
2710930|NCT01166347|Primary|Stroke-Free Survival Probability for 2 Years Post Implant|The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale >=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.|Implant to 2 years|Only randomized subjects who successfully received an implant are included.|||Probabillity|||Number
2710931|NCT01166282|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug.~For more details on adverse events please see the AE section below."|Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)|Safety population: All randomized subjects who received at least 1 dose of study drug|||participants|||Number
2710978|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL||12 Weeks post-randomization||||μg/mL||Inter-Quartile Range|Median
2710979|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710932|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)|The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used.|Baseline and Week 12|ITT population|||percentage of participants|||Number
2710933|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)|The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used.|Baseline and Week 12|ITT population|||percentage of participants|||Number
2710934|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)|The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data.|Baseline and Week 12|ITT population|||percentage of participants|||Number
2710935|NCT01166282|Secondary|Swollen Joint Count (SJC68): Change From Baseline to Week 12|Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population|||units on a scale||Standard Deviation|Mean
2710936|NCT01166282|Secondary|Tender Joint Count (TJC72): Change From Baseline to Week 12|Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population|||units on a scale||Standard Deviation|Mean
2710937|NCT01166282|Secondary|Number of Sites of Enthesitis: Change From Baseline to Week 12|The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population|||sites of enthesitis||Standard Deviation|Mean
2710938|NCT01166282|Primary|Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12|A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline and Week 12|ITT population|||percent change||Standard Deviation|Mean
2710939|NCT01166230|Secondary|Rate of Progression|"Only patients with Ta/T1 were included in the follow-up study. Progression is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence."|4.5 years||||percentage of patients|||Number
2710940|NCT01166230|Primary|Recurrence Free Survival||up to 4.5 years|Intention-to-treat (ITT)|||months||95% Confidence Interval|Median
2710941|NCT01166230|Other Pre-specified|Median Time to Recurrence||up to 4.5 years|ITT|||months||95% Confidence Interval|Median
2710942|NCT01166230|Other Pre-specified|Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB|To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.|up to 5.5 years retrospectively|ITT|||percentage of paticipants|||Number
2710943|NCT01166178|Secondary|Adverse Events and Serious Adverse Events Comparison of Treatment Groups|Adverse Events and Serious Adverse events are reported in the safety section.|24 months|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. The sample size was not powered for comparison between groups; however, all AEs are reported in the safety section.||||||
2710944|NCT01166178|Secondary|Course of Disease in Multiple Sclerosis Patients|The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist.|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710980|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
2710946|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip Region at 24 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710947|NCT01166178|Primary|Change in Bone Mineral Density of the Total Hip Region at 12 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710948|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 24 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710949|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 12 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710950|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip at 6 Months|Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710951|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 6 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710952|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 6 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710953|NCT01166178|Primary|Change in Bone Mineral Density of the Lumbar Spine at 12 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
2710954|NCT01166139|Secondary|Efficacy of Nilotinib in Patients With Systemic Sclerosis, as Defined by an Improvement in the Modified Rodnan Skin Score|"Improvement in Modified Rodnan skin score reported as a mean (units equals number of points).~The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. In each of these areas, the skin score is evaluated by manual palpation. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease."|12 months treatment||||units on a scale|||Number
2710955|NCT01166139|Secondary|Improvement of Modified Rodnan Skin Score Reported as a Mean (Units Equals Number of Points)|Efficacy of Nilotinib in patients with systemic sclerosis, as defined by an improvement in the Modified Rodnan Skin Score (MRSS) The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease.|6 Months of treatment||||units on a scale|||Number
2710956|NCT01166139|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||6 Months and 12 months treatment||||Adverse Events|||Number
2710957|NCT01166126|Secondary|Number of Participants With Related Serious Adverse Events (SAEs)|Toxicities assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.|1 year||||participants|||Number
2710981|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
2710982|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).|12 Weeks post-randomization||||percent change over baseline||Inter-Quartile Range|Median
2710958|NCT01166126|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months.|"Patients will be evaluated by physical examination and imaging assessments (brain MRI and CT scans of the chest, abdomen and pelvis). Disease progression will be defined by RECIST criteria on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|6 months from day 1 of treatment||||participants|||Number
2710959|NCT01166126|Primary|Number of Participants With Overall Survival (OS) at One Year|The one-year overall survival of the combination of temsirolimus and AZD6244 Hydrogen Sulfate.|1 year post last treatment||||participants|||Number
2710960|NCT01166126|Primary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Anti-tumor response (CR+PR) was defined by Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|1 year|All participants|||participants|||Number
2710961|NCT01165996|Secondary|Proportion of Patients With Particular Genetic Abnormalities Detected by Whole Exome Sequencing Correlation With Clinical Response|Proportion of patients with particular genetic abnormalities, including DNA Methyltransferase 1 (DNMT1) depletion, detected by whole exome sequencing correlation with clinical response|Baseline||||participants|||Number
2710962|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Terminal Differentiation Response to Therapy.|Number of participants who, after therapy, had more of the differentiated types of blood (red cells, platelets, and white cells) compared to abnormal bone marrow cells than before therapy|6 weeks after treatment||||participants|||Number
2710963|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Cytotoxicity.|Cytotoxicity is the ability to destroy cells. This will be measured by taking bone marrow samples and measuring the damage to cells. The level of cell destruction will be correlated with clinical response criteria.|6 weeks after treatment|Patients with chromosomal abnormalities which were evaluable for follow-up karyotyping|||participants|||Number
2710964|NCT01165996|Secondary|Proportion of Patients With Pharmacodynamic Evidence of Drug Effect.|Evidence of pharmacodynamic effect will be correlated with clinical response criteria. The pharmacodynamic effect of treatment is defined as the number of participants that had depletion DNMT1 with minimal DNA damage and cytotoxicity.|6 weeks after treatment|All subjects that had treatment with DNMT1 depletion.|||participants|||Number
2710965|NCT01165996|Secondary|Cytogenetic Response as Per IWG Criteria|Described as the number of patients with a major cytogenetic response (refers to disappearance of a cytogenetic abnormality) or a minor cytogenetic response (50% or more reduction of abnormal metaphases).|at 12 months|Patients that had cytogenetic abnormalities at baseline and were evaluable with follow-up metaphase karyotyping.|||participants|||Number
2710966|NCT01165996|Secondary|Number of Patients That Experience > Grade 2 Non-hematologic Toxicity by National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) v4 Criteria|Incidence of treatment-emergent adverse events (AEs) will be presented in tables that include causality, seriousness, severity/grade, and whether the AE resulted in death or discontinuation of treatment, Laboratory data will be summarized in tables that show changes from pre-treatment values and frequencies of abnormal values. Descriptive statistics will also be provided.|up to 12 months of treatment|All patients that received treatment.|||participants|||Number
2710967|NCT01165996|Primary|Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia|Complete Response (CR) include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease category than prior to treatment. Stable disease (SD) is defined by failure to achieve at least a partial response but no evidence of progression. Disease progression (DP) includes at least 50% decrease from maximum remission in granulocytes or platelets, reduction in hemoglobin by greater than or equal to 2g/dL, or transfusion dependence. Hematologic improvement (HI) includes hemoglobin increase by at least 1.5g/dL, reduction in transfusions, increase of platelets, increase of neutrophil count|Formal assessment at week 12 for study primary end-point (hematologic improvement).|All patients enrolled and that received any treatment.|||participants|||Number
2710968|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710969|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
2710970|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
2710971|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710972|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710973|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710974|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710975|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
2710976|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
2710977|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
2710983|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.|Baseline||||percentage change over baseline||Inter-Quartile Range|Median
2710984|NCT01165983|Primary|Nitroglycerine Induced Vasodilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|12 Weeks post-randomization||||percent change||Inter-Quartile Range|Median
2710985|NCT01165983|Primary|Nitroglycerin Induced Dilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|Baseline||||percent change||Standard Deviation|Mean
2710986|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|12 Weeks post-randomization|Number of subjects that completed the study|||percent change over baseline||Inter-Quartile Range|Median
2710987|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|Baseline||||percentage change over baseline||Standard Deviation|Mean
2710988|NCT01165840|Primary|Serum Clearance|Serum clearance of dapsone|72 hours||||L/h||Standard Deviation|Mean
2710989|NCT01165775|Secondary|Neonatal Hypoglycemia||birth to discharge|Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.|||participants|||Number
2710990|NCT01165775|Primary|Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment|During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (>110;>144;>180)|24-48 hours post betamethasone treatment|Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.|||percentage time||Standard Deviation|Mean
2710991|NCT01165684|Secondary|Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment.|Week 0 to Week 32|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. 397 subjects contributed with data.|||Episodes /year of patient exposure|||Number
2710992|NCT01165684|Secondary|Body Mass Index (BMI) at Week 32|Estimated mean BMI after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.|||kg/m^2||Standard Error|Mean
2710993|NCT01165684|Secondary|Body Weight at Week 32|Estimated mean body weight after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.|||kg||Standard Error|Mean
2710994|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32|Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 352 subjects contributed to the statistical analysis at Week 32.|||mmol/L||Standard Deviation|Mean
2710995|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 343 subjects contributed to the data at Week 21.|||mmol/L||Standard Deviation|Mean
2710996|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 326 subjects contributed to the data at Week 10.|||mmol/L||Standard Deviation|Mean
2710997|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 32|Estimated Mean FPG at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.|||mmol/L||Standard Error|Mean
2710998|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 21|Mean FPG at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the data at Week 21.|||mmol/L||Standard Deviation|Mean
2710999|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 10|Mean FPG at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 368 subjects contributed to data at Week 10.|||mmol/L||Standard Deviation|Mean
2711000|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32|Proportion of subjects reaching HbA1c below 7.0% at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.|||percentage (%) of subjects|||Number
2711001|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21|Proportion of subjects reaching HbA1c below 7.0% at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.|||percentage (%) of subjects|||Number
2711002|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10|Proportion of subjects reaching HbA1c below 7.0% at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.|||percentage (%) of subjects|||Number
2711003|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21|Estimated mean change from baseline in HbA1c after 21 Weeks of treatment|Week 0, Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2711004|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10|Estimated mean change from baseline in HbA1c after 10 Weeks of treatment|Week 0, Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2711005|NCT01165684|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32|Estimated mean change from baseline in HbA1c after 32 Weeks of treatment|Week 0, Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2711006|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.|Post flutemetamol administration.||||Percent of Specificity-Normal Reads||95% Confidence Interval|Number
2711007|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.|Post flutemetamol administration.||||Percent of Sensitivity-Abnormal Reads||95% Confidence Interval|Number
2711008|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.|"A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader N) divided by the (Total number of normal participants).~Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images."|Post Flutemetamol administrations|The assessment was done post-mortum based on the estimates of the presence of amyloid plaque in the brain.|||Percentage of Specificity by Reader|||Number
2711009|NCT01165554|Primary|The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.|"A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader N) divided by the (Total number of abnormal participants).~Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β."|Post flutemetamol administration.|The assessments were post-mortum based on the estimates of the presence of amyloid plaque in the brain.|||Percentage of Sensitivity by Reader|||Number
2711010|NCT01165541|Primary|Number of Very Heavy Drinking Days Per Week|"The number of very heavy drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week"|14 Weeks|The Analysis Population only consists of participants that completed both phases of the study.|||days||Standard Deviation|Mean
2711011|NCT01165450|Secondary|Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye|To compare, in each of the two patient populations, the percent reduction in epithelial defect size at Day 28 ± 2 compared to baseline, as measured by slit lamp examination with fluorescein staining. Epithelial defect size determined by pseudo-area, defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711012|NCT01165450|Secondary|Persistence of Complete Corneal Re-epithelialization in the Study Eye|To determine whether or not complete corneal re-epithelialization was persistent, as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye. The measurement will be made at Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711013|NCT01165450|Secondary|Change in the Rate of Re-epithelialization of the Study Eye|"To determine the change in the rate of re-epithelialization of the study eye from the screening run-in period to the treatment period, if applicable.~Time Frame: Screening period is defined as Day -7 to Day 0 ± 1. Treatment period is defined as Day 0 ± 1 through time of complete re-epithelialization. Time of complete re-epithelialization is defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2."|35 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711014|NCT01165450|Secondary|Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|To determine binary indicator of whether or not healing has occurred at 14 ± 1 days, defined as the largest diameter of the epithelial defect being smaller than 0.5 mm as determined by slit lamp examination with fluorescein staining.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711015|NCT01165450|Secondary|Time to Complete Re-epithelialization of the Study Eye|Resolution of epithelial defect is defined as the largest diameter of the epithelial defect being less than 0.5 mm, as it is difficult to distinguish a smaller defect from the small amount of fluorescing staining seen in a healed defect. Time of complete re-epithelialization will be defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711016|NCT01165450|Primary|Incidence of Adverse Events Following Application of the Investigational Product in All Subjects|Primary safety measure: To determine incidence of adverse events by recording their occurrence at each study visit through Day 28 ± 2. Analysis of safety data will be performed prior to each dose-escalation. If greater than 2 serious adverse events are found that are causally related to the investigational product, the study will be halted.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711017|NCT01165450|Primary|Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
2711018|NCT01165424|Secondary|Change From Baseline in the Total Nasal Symptom Score|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.|Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)|All treated participants|||units on a scale||Standard Error|Mean
2711019|NCT01165424|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions||Baseline to Week 24|All treated participants|||participants|||Number
2711020|NCT01165320|Primary|Percentage of Participants With One or More Drug-Related Adverse Experiences|An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.|Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days|The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for safety outcomes.|||Percentage of Participants|||Number
2711021|NCT01165320|Primary|Percentage of Participants With an Overall Favorable Response to Therapy|Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.|Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days|"The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for response to therapy. Participants whose overall response assessment was unable to judge were counted as having an unfavorable response."|||Percentage of Participants|||Number
2711022|NCT01165307|Secondary|Subject Satisfaction at 12 Months|Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||participants|||Number
2711023|NCT01165307|Secondary|Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)|The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||mm||Inter-Quartile Range|Median
2711024|NCT01165307|Secondary|Bleeding Pattern at 12 Months|"The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea normal pattern (none of the above patterns)."|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||participants|||Number
2711025|NCT01165307|Secondary|Indirect Medical Costs|Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||dollars||Standard Deviation|Mean
2711026|NCT01165307|Secondary|Direct Medical Costs|Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||dollars||Standard Deviation|Mean
2711027|NCT01165307|Secondary|Change in Ferritin From Baseline||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||ug/L||Inter-Quartile Range|Median
2711028|NCT01165307|Secondary|Ferritin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||ug/L||Inter-Quartile Range|Median
2711029|NCT01165307|Secondary|Change in Hemoglobin||baseline, 12 months|Only subjects who completed the 12 month visit were included in the analysis.|||g/dL||Inter-Quartile Range|Median
2711030|NCT01165307|Secondary|Hemoglobin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||g/dL||Inter-Quartile Range|Median
2711390|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2711031|NCT01165307|Secondary|Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )|The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2711032|NCT01165307|Secondary|Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
2711033|NCT01165307|Primary|Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).|The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2711034|NCT01165281|Secondary|Number of Patients Who Discontinued Due to Lack of Efficacy|The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy.|4 weeks|Time to discontinuation due to lack of efficacy was not analyzed since there was only 1 patient in the per-protocol set (in the tapentadol group) who discontinued treatment due to lack of efficacy.|||Number of participants|||Number
2711035|NCT01165281|Secondary|Proportion of Patients Entering the Maintenance Period|Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period.|4 weeks|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Percentage of Participants|||Number
2711036|NCT01165281|Secondary|Proportion of Patients With Various Levels of Pain Improvement (Responders)|The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Percentage of Participants|||Number
2711037|NCT01165281|Secondary|Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.|||Milligrams||Standard Deviation|Mean
2711038|NCT01165281|Secondary|Frequency of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.|||Number of doses per day||Standard Deviation|Mean
2711039|NCT01165281|Secondary|Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories|"The PGIC was rated by the patient and was based on the single question Since the start of this treatment, my cancer-related pain overall is, where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse."|Baseline, Endpoint of the 4-week Treatment Period|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Percentage of Participants|||Number
2711051|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits|Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.|From Month 0 to Month 8 post-vaccination|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
2711040|NCT01165281|Primary|Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale|"The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine. The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration."|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Scores on scale||Standard Deviation|Mean
2711041|NCT01165242|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 through Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2711042|NCT01165242|Secondary|Number of Subjects With New Onset of Chronic Illness(es) (NOCI)|NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.|From Month 0 through Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2711043|NCT01165242|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0-30) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2711044|NCT01165242|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
2711045|NCT01165242|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
2711046|NCT01165242|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response was defined as: -for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.|One month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2711047|NCT01165242|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Titers||95% Confidence Interval|Geometric Mean
2711048|NCT01165242|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2711049|NCT01165242|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2711050|NCT01165242|Primary|Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies|"Vaccine response was defined as:~for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination;~for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination."|One month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2711052|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs|Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
2711053|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs|Fatal SAEs during the entire study period in subjects ≥ 70 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
2711054|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs|Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.|From Month 0 to Month 14|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
2711055|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA|Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after each vaccination|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
2711056|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
2711057|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
2711058|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.|Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
2711059|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.|The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711060|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ|Occurrence of PHN during the entire study period in all subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711061|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA|Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711062|NCT01165229|Secondary|Number of Subjects With Any and Related Medically Attended Visits|Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.|From Month 0 to Month 8 post-vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711063|NCT01165229|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects|During the entire study period (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711064|NCT01165229|Secondary|Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication|The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated|During the entire study period (3 to 5 year period following day 0)|The analysis was based on the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered|||Participants|||Count of Participants
2711065|NCT01165229|Secondary|Number of Subjects With Fatal Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711066|NCT01165229|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 14|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711067|NCT01165229|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30 days (Days 0-29) after each vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711068|NCT01165229|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period|||Participants|||Count of Participants
2711069|NCT01165229|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period|||Participants|||Count of Participants
2711070|NCT01165229|Secondary|Number of Days With Pain Medication Associated With HZ|Incidence of reduction of duration of pain medication associated with HZ throughout the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
2711091|NCT01165203|Secondary|Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications||From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711071|NCT01165229|Secondary|Number of Subjects Receiving Pain Medication Associated With HZ|Incidence of use of pain medications throughout the study|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711072|NCT01165229|Secondary|Number of Subjects With HZ Related Complications|Incidence of HZ complications during the study in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711073|NCT01165229|Secondary|Number of Subjects With Confirmed HZ Episode Related Hospitalizations|Incidence of overall and HZ-related hospitalizations during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711074|NCT01165229|Secondary|Number of Subjects With Overall Mortality and HZ-related Mortality|The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711075|NCT01165229|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations|The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711076|NCT01165229|Secondary|Number of Days With Severe 'Worst' HZ-associated Pain|Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
2711077|NCT01165229|Secondary|Number of Subjects With Post-herpetic Neuralgia (PHN)|PHN cases in the mTVc.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711078|NCT01165229|Primary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ|Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711079|NCT01165229|Primary|Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)|Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711080|NCT01165229|Primary|Number of Subjects With Any Episodes of Herpes Zoster (HZ)|Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711081|NCT01165216|Secondary|Serum Half-life (T-HALF) of Ipilimumab|T-HALF was calculated as the ratio of ln(2) to elimination rate constant (K), where K was estimated as negative slope obtained by regression of the terminal log-linear portion of the serum concentration vs time profile following the ipilimumab dose on Day 1 of Cycle 3. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods, using a validated PK analysis program. Actual times were used for the analyses. T-HALF measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||Days||Standard Deviation|Mean
2711199|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score â‰¤3.2|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711082|NCT01165216|Secondary|Time of Maximum Observed Serum Concentration (Tmax)|Tmax was recorded directly from experimental observations. Actual times were used for the analyses. Tmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||Hours||Full Range|Median
2711083|NCT01165216|Secondary|Area Under the Concentration Curve From Time 0 to Day 21 (in 1 Interval Dosing) (AUC[0-21d]) for Ipilimumab|The AUC(0-21d) was calculated using a mixture of log- and linear-trapezoidal summations. Using no weighting factor, the terminal log-liner phase of the concentration-time curve was determined by least-square linear regression of at least 3 data points. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods using a validated PK analysis program. Actual times were used for the analyses. AUC(0-21d) measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
2711084|NCT01165216|Secondary|Trough Observed Serum Concentration (Cmin) of Ipilimumab|Cmin was recorded directly from experimental observations. Actual times were used for the analyses. Cmin measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 (Day 8), and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||ug/mL||Standard Deviation|Mean
2711085|NCT01165216|Secondary|Maximum Serum Concentration (Cmax) of Ipilimumab|Cmax was recorded directly from experimental observations. Actual times were used for the analyses. Cmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2711086|NCT01165216|Secondary|Number of Participants With Best Overall Response (BOR) of Partial Response (PR) or Stable Disease|Tumor response was determined for all participants with measurable lesions by radiologic responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The BOR was the best response recorded from start of treatment until disease progression/recurrence. RECIST for target lesions: PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started. At minimum, tumor measurements were to be obtained at screening, every 6 weeks (±1 week) during the induction phase and every 12 weeks (±1 week) during the maintenance phase.|Day 1 of Cycle 3, Day 1 of Cycle 5, and Day 22 of Cycle 6|Participants who received at least 1 dose of study drug|||Participants|||Number
2711087|NCT01165216|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. AE incidence was assessed from Day 1 until Week 24 and every 12 weeks thereafter during the maintenance period, until discontinuation of study drug, due to progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure, and at least every 4 weeks(±1 week) until all study drug-related toxicities had recovered to resolved, stabilized or returned to baseline or were deemed irreversible during the follow-up period).|Continuously from Day 1 to Week 24 and every12 weeks thereafter during maintenance until discontinuation of drug|Participants who received at least 1 dose of any study drug|||Participants|||Number
2711088|NCT01165216|Primary|Number of Participants Experiencing a Dose-limiting Toxicity (DLT)|A DLT was defined as study drug-related adverse event occurring during the first 2 cycles after ipilimumab administration in the induction phase and was any of the following: Grade 4 absolute neutrophil count (ANC) decreased (<500 cells/ mm^3) for 7 or more consecutive days; febrile Neutropenia (body temperature ≥38.5° C with ANC <1000 /mm^3) lasting >3 days; Grade 4 platelet count decreased (<25,000 cells/mm^3) or Grade 3 platelet count decreased requiring a platelet transfusion; Grade 3 or greater nausea, vomiting, diarrhea, despite the use of adequate/maximal medical intervention; Grade 3 or greater aspartate transaminase/alanine transaminase level and rash that has not resolved to Grade 2 or lower within 2 weeks after onset; or any Grade 3 or greater nonhematologic toxicity (except Grade 3 fatigue, Grade 3 asthenia, Grade 3 transient arthralgia/myalgia, or Grade 3 transient abnormal electrolyte levels).|Day 1 of Cycles 1 and 2 From Day 1 of Cycle 3 to Day 21 of Cycle 4|Participants who received at least 1 dose of ipilimumab|||Participants|||Number
2711089|NCT01165203|Secondary|HIV VL|HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.|At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18|The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.|||HIV-RNA copies/mL||Standard Deviation|Mean
2711090|NCT01165203|Secondary|CD4 Count|CD4 count was tabulated by HIV status.|At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||CD4 T-cells/million T-cells||Standard Deviation|Mean
2711092|NCT01165203|Secondary|-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status|Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||mIU/mL||95% Confidence Interval|Geometric Mean
2711093|NCT01165203|Secondary|-Anti-VZV and Anti-gE Antibody Concentrations|Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||mIU/mL||95% Confidence Interval|Geometric Mean
2711094|NCT01165203|Secondary|-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status|The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||CD4 T-cells/million T-cells||Standard Deviation|Mean
2711095|NCT01165203|Secondary|-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells|The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.|At Month 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||CD4 T-cells/million T-cells||Standard Deviation|Mean
2711096|NCT01165203|Primary|-Anti-gE Antibody (Ab) Concentrations|-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|At Month 7||||mIU/mL||95% Confidence Interval|Geometric Mean
2711097|NCT01165203|Primary|Frequency of gE-specific CD4 T-cells|The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7.|||CD4 T-cells/million T-cells||Standard Deviation|Mean
2711098|NCT01165203|Primary|Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status|In this analysis, results were tabulated by HIV status.|From Month 1 to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711099|NCT01165203|Primary|Number of Subjects With Any AIDS-defining Condition, by HIV Status|In this analysis, results were tabulated by HIV status|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711100|NCT01165203|Primary|Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status|In this analysis, results were tabulated by HIV status|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711101|NCT01165203|Primary|Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count|In this analysis, results were tabulated for the main study groups.|From Month 1 to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711102|NCT01165203|Primary|Number of Subjects With Any AIDS-defining Condition|In this analysis, results were tabulated for the main study groups.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711103|NCT01165203|Primary|Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects|In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711104|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.|At Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711993|NCT01158118|Secondary|Relapse and Disease Progression Rate|-A patient will be considered relapsed (disease progressed) when there is a recurrence of the original malignant disease after transplantation.|Up to 1 year||||Participants|||Count of Participants
2711105|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711106|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.|At Month 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711107|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 2|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711108|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711109|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Screening Visit (up to 21 days prior to Month 0)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711110|NCT01165203|Primary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711111|NCT01165203|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711112|NCT01165203|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2711113|NCT01165203|Primary|Number of Subjects With Any Adverse Events (AEs) of Specific Interest|AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711114|NCT01165203|Primary|Number of Subjects With Any Fatal SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening (up to 21 days prior to Month 0) until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711115|NCT01165203|Primary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening (up to 21 days prior to Month 0) until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711116|NCT01165203|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2711117|NCT01165177|Secondary|Number of Subjects With Fatal SAEs|Number of subjects with fatal SAEs during the entire study period were tabulated|During the entire study period (3 to 5 years following day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711118|NCT01165177|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine|The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on TVC, which included all subjects with at least one dose of the study vaccine or place administered.|||Participants|||Count of Participants
2711119|NCT01165177|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711120|NCT01165177|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after each vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711121|NCT01165177|Secondary|Number of Subjects With AEs With Any and Related Medically Attended Visit|Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.|From Month 0 to Month 8 post-vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711122|NCT01165177|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects|During the entire study period (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
2711123|NCT01165177|Secondary|Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)|Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated|Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
2711124|NCT01165177|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the TVc – Diary Card, which was a subset of subjects from the TVc, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
2711125|NCT01165177|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
2711126|NCT01165177|Secondary|Number of Days of Pain Medication Associated With HZ|The analysis was performed on subjects with a confirmed HZ episode|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
2711127|NCT01165177|Secondary|Distribution of Pain Medication Associated With HZ|The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711128|NCT01165177|Secondary|Number of Subjects With HZ Related Complications, by Complication Type|Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711129|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations|The analysis focused on confirmed HZ episode related hospitalizations and deaths.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711130|NCT01165177|Secondary|Number of Days With Severe 'Worst' HZ-associated Pain.|Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
2711131|NCT01165177|Secondary|Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ|The analysis focused on subjects taking pain medication due to HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711132|NCT01165177|Secondary|Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ|The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711133|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Hospitalizations|The analysis focused on confirmed HZ episode related hospitalizations.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711134|NCT01165177|Secondary|Number of Subjects With HZ Related Complications|The analysis focused on the incidence of HZ complications in subjects with confirmed HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711135|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality|The analysis focused on the number of subjects who died due to HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711136|NCT01165177|Secondary|Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain|Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711137|NCT01165177|Secondary|Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)|The incidence of PHN was calculated using the modified total vaccinated chort.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711391|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2711138|NCT01165177|Primary|Number of Subjects With Confirmed Herpes Zoster (HZ) Cases|Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2711139|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Reason for Incorrect Inhaler Use and Who Required Additional Instruction the Indicated Number of Times at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed based on 3 steps: open the device, inhale the dose, and close the device. If the participants did not perform the maneuvers correctly, the step of the inhaler use that was performed incorrectly by the participants was recorded. The entire procedure was demonstrated once again. and the number of times that the participants required additional instruction (RAI) was recorded.|Baseline, Week 2, and Week 4|ITT Population. Only those participants who used the inhaler incorrectly at the specified time points were analyzed.|||participants|||Number
2711140|NCT01165138|Other Pre-specified|Number of Participants Who Used the Inhaler Correctly or Incorrectly at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed.|Baseline (BL), Week 2 (W2), and Week 4 (W4)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2711141|NCT01165138|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician's office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare were recorded.|From Baseline up to Week 12/Early Withdrawal|ITT Population|||Number of visits||Standard Deviation|Mean
2711142|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Responses at Week 4, Week 8, and Week 12/Early Withdrawal|At the end of Week 4, Week 8, and Week 12/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptom); much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 8, and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2711143|NCT01165138|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Score at Week 12|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12/Early Withdrawal minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|||Scores on a scale||Standard Error|Least Squares Mean
2711144|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2711145|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2711146|NCT01165138|Other Pre-specified|Number of Participants With Bronchodilator Effect|Bronchodilator effect is defined as an increase of FEV1 (defined as the maximal amount of air that can be forcefully exhaled in one second) from Baseline of both 12% and 200 milliliters (mL) during 24 hours, which was evaluated using the serial FEV1 measurements at Baseline (Visit 3).|Baseline|ITT Population. Only the subset of participants performing serial measurements were analyzed.|||participants|||Number
2711236|NCT01164137|Primary|Health Services Utilization 6 Months Following Hospital Discharge|Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|6 Months||||Health Services Utilizations||Standard Error|Mean
2711147|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-4 Hours Post-dose at Baseline and Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean serial FEV1 over 0-4 hours was calculated using the serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 12 was performed. Only those participants available at the specified time points were analyzed.|||Liters||Standard Deviation|Mean
2711148|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Baseline|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 was performed.|||Liters||Standard Deviation|Mean
2711149|NCT01165138|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1 at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. The highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Week 12|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 12 was performed.|||Liters||Standard Error|Least Squares Mean
2711150|NCT01165138|Secondary|Serial FEV1 Over 0-1 Hour Post-dose at Randomization|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.|Randomization|ITT Population. Serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed|||Liters||Standard Error|Least Squares Mean
2711151|NCT01165138|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 12/Early Withdrawal|ITT Population|||participants|||Number
2711152|NCT01165138|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates total impairment and a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|||Score on a scale||Standard Error|Least Squares Mean
2711153|NCT01165138|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2711154|NCT01165138|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2711436|NCT01163214|Secondary|Narcotic Use|Use of additional narcotic medications (as needed), measured in morphine equivalents.|Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2|Intention to treat analysis|||mg||Standard Deviation|Mean
2711155|NCT01165138|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed at Week 12.|||Liters||Standard Error|Least Squares Mean
2711156|NCT01165138|Primary|Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
2711157|NCT01165112|Secondary|Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)||Up to 5 weeks after the last course||||Participants|||Count of Participants
2711158|NCT01165112|Secondary|Preliminary Assessment of the Efficacy of This Regimen|Response will be defined by standard NCI criteria (Cheson et al) for lymphoid malignancies.|Up to 5 weeks after the last course||||Participants|||Count of Participants
2711159|NCT01165112|Primary|Safety and Toxicity of This Regimen|Count of participants experiencing a dose limiting toxicity. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 will be used to classify and grade toxicities.|Up to 5 weeks after the last course||||Participants|||Count of Participants
2711160|NCT01165112|Primary|Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies|Defined as dose at which approximately =< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level that would have been assigned to next cohort is taken as MTD.|Up to 5 weeks after the last course||||mg/m2 x 2|||Number
2711161|NCT01165047|Primary|Number of Participants With Side Effects and/or Adverse Events|A phone contact will be made to the subject 5 days after the trial to assess general health status and collect information on any reported side effects or adverse events.|5 days||||participants|||Number
2711162|NCT01165021|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Enrollment until the first date of objectively determined PD or death up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=3.|||months||95% Confidence Interval|Median
2711163|NCT01165021|Secondary|Overall Survival (OS)|OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.|Enrollment until the date of death from any cause up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=8|||months||95% Confidence Interval|Median
2711164|NCT01165021|Secondary|Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0|Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2711165|NCT01165021|Secondary|Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]|pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.|At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)|Participants who received at least 1 dose of preoperative chemotherapy and had surgical tumor tissue samples available.|||percentage of participants||95% Confidence Interval|Number
2711166|NCT01165021|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2711167|NCT01164956|Secondary|Change Over Treatment Pairs in pedsFACIT-F Score|The pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (pedsFACIT-F) is an 11-item instrument derived from a comprehensive pediatric item bank that assesses fatigue. (Lai et al. Pediatr Hematol Oncol 2007) Measuring fatigue over the past 7 days in a population of pediatric cancer patients, the pedsFACIT-F instrument has a score ranging from 0-44, with a higher score meaning more fatigue. A minimally important difference (MID) was established as 4.7 points.|The pedsFACIT-Fwas administered at baseline and at the end of each treatment pair (TP) and related change in score was calculated for each period: baseline to end of TP 1 (day 6); end of TP 1 to end of TP 2 (day 12); end of TP 2 to end of TP 3 (day 18).|The analysis dataset is comprised of all enrolled patients with data at baseline and end of all treatment pairs.|||units on a scale|||Number
2711168|NCT01164956|Secondary|Rate of Receiving Clinically Definite Answer Regarding the Ability of Experimental Treatment to Reduce Fatigue Using the N-1-T Design|Efficacy of the N-1-T design is defined as patient providing a clinically definite answer regarding the ability of MPH to reduce fatigue.Based on the definition of the outcome being evaluated, aggregation of data for all participants is appropriate.|18 days|The analysis dataset is comprised of all enrolled patients.|||participants|||Number
2711169|NCT01164956|Primary|Completion Rate of Two Treatment Pairs Using the N-1-T Design|The feasibility of conducting an N-1-T to evaluate MPH for cancer-related fatigue will be determined by the completion rate of two MPH-placebo pairs.|18 days|The analysis dataset is comprised of all enrolled patients. Based on the definition of the outcome being evaluated, aggregation of data for all participants is appropriate.|||participants|||Number
2711170|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Urine Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples). Data for parent drug (RO5185426) and metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.|||percentage of total dose administered||Standard Deviation|Mean
2711171|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Urine of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples), Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.|||percentage of total radioactivity||Standard Deviation|Mean
2711172|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Fecal Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over 2 time intervals (0-24 + 24-48 hours, 48-72 + 72-96 hours) for measurement of 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, glucuronide) levels.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.|||percentage of total dose administered||Standard Deviation|Mean
2711173|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Feces of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over two time intervals for this analysis (0-24 + 24-48 hours, 48-72 + 72-96 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, and glucuronide) are reported.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.|||percentage of total radioactivity||Standard Deviation|Mean
2711197|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711174|NCT01164891|Primary|Plasma 14C-labeled RO5185426 and 14C-labeled Metabolite Levels|Collection of samples for radioactivity continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48 hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). The concentrations were measured in nanogram equivalent per gram which was calculated based on ratio of dosed radioactivity and the last dose of RO5185426. The concentration values represented the drug portion of the last dose. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.|||nanogram equivalent per gram||Standard Deviation|Mean
2711175|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Plasma of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.|||percentage of total radioactivity||Standard Deviation|Mean
2711176|NCT01164891|Primary|14C-labeled RO5185426 Recovery: Percentage of Dose Excreted in Feces and Urine|Urinary and fecal samples were analyze for the percentage dose recovered as total radioactivity. The radioactivity was determined on a Packard liquid scintillation counter. Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|Urine:0 hour (pre dose),in quantitative fraction(0-6,6-12,12-24 hours) post dose on Day 15,during 24 hour interval thereafter;Feces:From Day 14 upto pre dose on Day 15,during 24 hour interval post dose until recovery criterion;(maximum:432 hours for both)|PK Analysis Population. One participant was excluded in the analysis because of contamination of urine sample with feces.|||percentage of dose recovered||Standard Deviation|Mean
2711177|NCT01164891|Primary|AUC Ratio of Blood:Plasma 14C-labeled RO5185426|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analysed = participants with measurable data for this outcome.|||ratio||Standard Deviation|Mean
2711178|NCT01164891|Primary|Half-life of 14C-labeled RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||hour||Standard Deviation|Mean
2711179|NCT01164891|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUClast) of 14C-RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1mSv.|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||(micrograms equivalent/milliliter)*hour||Standard Deviation|Mean
2711180|NCT01164891|Primary|Time to Reach Cmax in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||hours||Full Range|Median
2711181|NCT01164891|Primary|Maximum Plasma Concentration of 14C-labeled RO5185426 (Cmax) in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1 millisieverts (mSv).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||micrograms equivalent per milliliter||Standard Deviation|Mean
2711182|NCT01164891|Secondary|Overall Survival|Overall survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until death (maximum 841 days)|The data was not collected, as planned, due to small number of participants enrolled in the study.||||||
2711198|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score <2.6|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711437|NCT01163214|Primary|Post-Operative Pain|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
2711183|NCT01164891|Secondary|Number of Participants With a Response by Confirmed Best Overall Response|Best overall response (according to Response Evaluation Criteria In Solid Tumors 1.1 criteria) was defined as best response recorded from start of treatment until disease progression which included complete response (CR) or partial response (PR) that had been confirmed by second tumor assessment no less than (<) 4 weeks after criteria for response were first met. Confirmed CR: disappearance of all target and non-target lesions; no new lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). Confirmed PR: at least 30% decrease in sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression: at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until disease progression, withdrawal from study or death (maximum 841 days)|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2711184|NCT01164891|Primary|Plasma RO5185426 Trough Concentrations on Days 15,16, and 17||Pre-dose on Days 15, 16 and 17|Pharmacokinetic (PK) Analysis Population: participants from whom the level of radioactivity recovered from excreta (urine and feces) was ≤ 1% of the radioactivity in the administered dose between any two successive 48-hour interval assessments.|||micrograms per milliliter||Standard Deviation|Mean
2711185|NCT01164865|Primary|Likert Questionnaire Scores at 2 Weeks|The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.|2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2711186|NCT01164865|Primary|Change From Baseline in Ocular Comfort Rating at 2 Weeks|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described how your eyes feel right now."|Baseline (Day 0), 2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2711187|NCT01164722|Secondary|Incidence of Metachronous Lesions|Number of patients with one or more metachronous lesions|one year on study|Patents with any biopsy from randomization to one year|||Participants|||Count of Participants
2711188|NCT01164722|Secondary|Recurrence Rate at 1 Year||1 year on study|Patients who were treated with IRC, no data were collected on patients on the expectant management arm|||Percentage of lesions that recurred|||Number
2711189|NCT01164722|Secondary|Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year|Number of patients who had high grade anal intraepithelial neoplasia at one year.|1 year on study|Patients who had an evaluable biopsy within one year after randomization.|||Participants|||Count of Participants
2711190|NCT01164722|Secondary|Tolerability and Safety of Infrared Coagulator Ablation|Number of patients who experienced a serious adverse events|All study visits through year 2||||participants|||Number
2711191|NCT01164722|Primary|Complete Response Through 1 Year|No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.|1 year post treatment|All study participants who were randomized and attended the baseline visit.|||participants|||Number
2711192|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number ten. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 10||||a ratio of pixels||Standard Error|Mean
2711193|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number seven. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 7||||a ratio of pixels||Standard Error|Mean
2711194|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising in based on a ratio of pixels on post-operative day number three. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.|Post-operative day 3||||a ratio of pixels||Standard Error|Mean
2711195|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) <2.6|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711196|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) â‰¤3.2|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711200|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711201|NCT01164579|Secondary|Change From Baseline in DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
2711202|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity. DAS28-4 (ESR) â‰¤3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2711203|NCT01164579|Secondary|Change From Baseline in DAS28-3 (CRP)|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
2711204|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (â‰¤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assess for the specified parameter at a given visit.|||score on a scale||Standard Deviation|Mean
2711205|NCT01164579|Secondary|Percentage of Participants With an ACR 70% Improvement (ACR70) Response|ACR70 response: â‰¥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711206|NCT01164579|Secondary|Percentage of Participants With an ACR 50% Improvement (ACR50) Response|ACR50 response: â‰¥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assess for the specified parameter at a given visit.|||percentage of participants|||Number
2711207|NCT01164579|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response|ACR20 response: greater than or equal to (â‰¥)20% improvement in tender joint count; â‰¥20% improvement in swollen joint count; and â‰¥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Months 1, 2, 3, 6, 9, and 12|FAS Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders. n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2711208|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in Erosion Score|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
2711209|NCT01164579|Secondary|Erosion Scores at Months 6 and 12|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
2711210|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in JSN Scores|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
2711211|NCT01164579|Secondary|Joint Space Narrowing (JSN) Scores at Months 6 and 12|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||score on a scale||Standard Error|Least Squares Mean
2711212|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in mTSS|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
2711213|NCT01164579|Secondary|Modified Total Sharp Score (mTSS) at Months 6 and 12|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||score on a scale||Standard Error|Least Squares Mean
2711214|NCT01164579|Secondary|Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions|Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.|Months 1, 3, 6, and 12|Evaluable Set|||score on a scale||Standard Error|Least Squares Mean
2711215|NCT01164579|Secondary|Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP|"Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€33% of bone edematous; 2: 34â€66% of bone edematous; 3: 67â€100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity."|Months 1, 3, and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||score on a scale||Standard Error|Least Squares Mean
2711216|NCT01164579|Secondary|Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Months 1, 6, and 12|Evaluable Set|||score on a scale||Standard Error|Least Squares Mean
2711217|NCT01164579|Primary|Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Month 6|Evaluable Set|||score on a scale||Standard Error|Least Squares Mean
2711218|NCT01164579|Primary|Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Month 3|Evaluable Set: all randomized participants who received at least 1 dose of the randomized investigational drug and for whom a variable is nonmissing at both baseline and the specified timepoint.|||score on a scale||Standard Error|Least Squares Mean
2711219|NCT01164501|Other Pre-specified|Hypoglycaemic Events|Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.|From first drug administration until 7 days after last trial medication intake, up to 458 days|Treated set which included all patients treated with at least one dose of randomised trial medication.|||percentage of participants|||Number
2711220|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
2711221|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
2711222|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
2711223|NCT01164475|Secondary|Terminal Elimination Half-life (T1/2)|T1/2 is the time required for the plasma concentration to decrease to one half.|0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||hours||Standard Deviation|Mean
2711224|NCT01164475|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all patients who have signed informed consent and received at least one dose of study drug.|||hours||Full Range|Median
2711225|NCT01164475|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||ng/mL||Standard Deviation|Mean
2711226|NCT01164475|Secondary|Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor|Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.|Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||fold increase||Standard Deviation|Mean
2711227|NCT01164475|Secondary|Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||10^6 cells/kg||Full Range|Median
2711228|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.|||days||Full Range|Median
2711229|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.|||days||Full Range|Median
2711230|NCT01164475|Secondary|Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||percentage of participants|||Number
2711231|NCT01164475|Primary|Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
2711232|NCT01164475|Primary|Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||percentage of participants|||Number
2711233|NCT01164137|Primary|Health Services Utilization 18 Months Following Hospital Discharge|Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|18 months||||Health Services Utilizations||Standard Error|Mean
2711234|NCT01164137|Primary|Health Services Utilization 12 Months Following Hospital Discharge|Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|12 months||||Health Services Utilizations||Standard Error|Mean
2711235|NCT01164137|Primary|Health Services Utilization 9 Months Following Hospital Discharge|Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|9 Months||||Health Services Utilizations||Standard Error|Mean
2711760|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36||||percentage of participants|||Number
2711237|NCT01164137|Primary|Health Services Utilization 3 Months Following Hospital Discharge|Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|3 Months||||Health Services Utilizations||Standard Error|Mean
2711238|NCT01164098|Secondary|Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)|Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula|12 months post-transplant|Intent-to-Treat Analysis|||ml/min/1.73 m^2||Standard Error|Mean
2711239|NCT01164098|Secondary|Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12|Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach.|Post-Transplant Months 3-12|Intent-to-Treat Analysis|||ratio||Standard Error|Geometric Mean
2711240|NCT01164098|Primary|Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.|Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach.|between post-transplant day 3 and day 30|Intent-to-Treat Analysis|||ratio||Standard Error|Geometric Mean
2711241|NCT01164007|Secondary|Overall Survival (OS)|OS was defined as the time from Baseline visit to the time of death from any cause. OS was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||months||95% Confidence Interval|Median
2711242|NCT01164007|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||percentage of participants|||Number
2711243|NCT01164007|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from start of treatment to the time of treatment discontinuation as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTF was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||months||95% Confidence Interval|Median
2711244|NCT01164007|Secondary|Percentage of Participants Who Discontinued Treatment|The percentage of participants who discontinued treatment as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||percentage of participants|||Number
2711245|NCT01164007|Secondary|Time to Progression (TTP) According to RECIST|Tumor assessments were performed using RECIST. TTP was defined as the time from Baseline visit to time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTP was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||months||95% Confidence Interval|Median
2711246|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). The percentage of participants who died or demonstrated disease progression was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||percentage of participants|||Number
2711247|NCT01164007|Secondary|DOR With CR, PR, or SD According to RECIST|Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR, PR, or SD to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. DOR was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR, PR, or SD."|||months||95% Confidence Interval|Median
2711248|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR, PR, or SD was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR, PR, or SD."|||percentage of participants|||Number
2711293|NCT01163851|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||nanogram*hour per milliliter||Standard Deviation|Geometric Mean
2711249|NCT01164007|Secondary|Duration of Response (DOR) With CR or PR According to RECIST|Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR or PR to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. DOR was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR or PR."|||months||95% Confidence Interval|Median
2711250|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR or PR was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR or PR."|||percentage of participants|||Number
2711251|NCT01164007|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline. Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR. The percentage of participants with a best overall response of CR or PR during the study was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|Intent-to-Treat (ITT) Population: All participants who signed the ICF, were assigned a study identifier, and received at least one dose of study medications.|||percentage of participants|||Number
2711252|NCT01163955|Primary|Posture Control of Head Position, Shoulder Position and Back Position|Forward Head Position (FHP), Rounded Shoulder Position (RSP), and Thoracic spine (T/s)-Lumbar spine (L/s) positions were scored. Subscale scores of 0-3 for each FHP, RSP, and T/s L/s position were obtained. Score 0 was a perfect posture score, Score 1 was 0-1 inches out of alignment. Score 2 was 1-2 inches out of alignment. Score 3 was 2-3 inches out of alignment. Subscale scores were combined for a total score with a minimum value of 0 and a maximum value of 9. 0 being a perfect posture score, 9 being the worst postural score.|5 minute||||scores on a scale||95% Confidence Interval|Mean
2711253|NCT01163916|Secondary|Duration of Treatment With Adalimumab|Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.|For the duration of the study (up to a maximum of 18.2 months).|Safety set.|||weeks||Full Range|Median
2711254|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment|Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.|Baseline and at each follow-up visit (up to a maximum of 18.2 months).|Safety set|||participants|||Number
2711255|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Duration of Disease|Duration of disease was defined as the time from diagnosis until study entry.|Baseline|Safety set|||months||Full Range|Median
2711256|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Disease Severity|Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.|Baseline|Safety set.|||participants|||Number
2711257|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Marital Status|Participants were asked to indicate their marital status at the Baseline visit.|Baseline||||participants|||Number
2711258|NCT01163916|Secondary|Percentage of Participants With Missed or Delayed Injections|Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.|For the duration of the study (up to a maximum of 18.2 months).|Safety set; the analysis only includes participants with non-missing data.|||percentage of participants|||Number
2711259|NCT01163916|Secondary|Patient's Acceptability of Self-injections|"At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were convenient, inconvenient and unable to self-inject.~The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.~Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization."|Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.|The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.|||participants|||Number
2711260|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Residence Status|Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.|Baseline||||participants|||Number
2711261|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Occupation|Participants were asked to indicate their occupation at the Baseline visit.|Baseline||||participants|||Number
2711262|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Education Level|Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.|Baseline||||participants|||Number
2711263|NCT01163851|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA)|Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies. Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711264|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters|Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade. Categories with at least 1 participant were reported.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711265|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. ECG parameters RR interval, PR interval, QRS complex, QT interval, [Bazett's Correction], QTcF interval [Fridericia's Correction] were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711266|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic adverse events. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711267|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic AEs.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711268|NCT01163851|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711269|NCT01163851|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. AEs were assessed for severity by CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711270|NCT01163851|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and non-serious adverse events.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711331|NCT01163318|Secondary|Incidence of Infections and Malignant Tumors|Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.|||Percentage of participants|||Number
2711271|NCT01163851|Secondary|Number of Participants With Toxicity or Intolerable Dose Criteria|Toxicity criteria included any of the following: serious adverse event; increased liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]: increased to greater than [>] 5*upper limit of normal reference range [ULN]); increased bilirubin (in absence of ALT or AST elevations, common terminology criteria for adverse events [CTCAE] greater than or equal to [>=] Grade 2); pancreatitis, increased serum creatinine (CTCAE >= Grade 2); creatine kinase, hyperglycemia or hypoglycemia, diarrhea or enteritis or nausea (CTCAE >= Grade 3); decreased platelet count (less than [<] 100000 per microliter); prolongation of QT interval with Fridericia's Correction (QTcF) (QTcF >500 millisecond [msec] [CTCAE >= Grade 3] or increase from baseline of >=60 msec) and other considered appropriate by investigator. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
2711272|NCT01163851|Secondary|Duration of Low Density Lipoprotein (LDL) Lowering Effects|In this outcome measure duration of the lipid-lowering effects was reported. Lipid lowering was defined as decrease in LDL-C levels by greater than or equal to 15 percent.|Day 4 to Day 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.|||days||Full Range|Median
2711273|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711274|NCT01163851|Secondary|Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711275|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711276|NCT01163851|Secondary|Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711277|NCT01163851|Secondary|Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711278|NCT01163851|Secondary|Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711279|NCT01163851|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
2711280|NCT01163851|Secondary|Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711332|NCT01163318|Primary|Incidence of Adverse Drug Reactions (ADRs)|An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.|||Percentage of participants|||Number
2711281|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711282|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711283|NCT01163851|Secondary|Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711284|NCT01163851|Secondary|Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711285|NCT01163851|Secondary|Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711286|NCT01163851|Secondary|Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
2711287|NCT01163851|Primary|Apparent Volume of Distribution (Vz/F) of Atorvastatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' is signifying those participants who were evaluable for this measure for each group respectively.|||liter||Standard Deviation|Geometric Mean
2711288|NCT01163851|Primary|Apparent Oral Clearance (CL/F) of Atorvastatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||liter per hour||Standard Deviation|Geometric Mean
2711289|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of Atorvastatin|Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||hour||Standard Deviation|Mean
2711290|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram per milliliter||Standard Deviation|Geometric Mean
2711291|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2711292|NCT01163851|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin|AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Standard Deviation|Geometric Mean
2711333|NCT01163292|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.|Week 0 to Week 52|All participants registered|||participants|||Number
2711294|NCT01163851|Primary|Volume of Distribution at Steady State (Vss) of PF-04950615|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||liter||Standard Deviation|Geometric Mean
2711295|NCT01163851|Primary|Systemic Clearance (CL) of PF-04950615|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||liter per hour||Standard Deviation|Geometric Mean
2711296|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of PF-04950615|Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||hour||Standard Deviation|Mean
2711297|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram per milliliter||Standard Deviation|Geometric Mean
2711298|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2711299|NCT01163851|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Standard Deviation|Geometric Mean
2711300|NCT01163786|Secondary|Short Form (SF)-36 Health Survey|"This is a quality of life questionnaire which yields scores for 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). This questionnaire will be completed by patients on Visit 1 (week 1), Visit 5 (week 5), Visit 8 (week 8), Visit 9 (12 weeks), and Visit 10 (18 weeks).~Questionnaires were scored per the scoring rules for the RAND 36-Item Health Survey (version 1.0) A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered."|up to 18 weeks|Data was collected but not analyzed. Averages for each patient at each timepoint are shown below. N/a is shown for timepoints where data was not collected.|||Average Score|||Number
2711301|NCT01163786|Secondary|Exercise Tolerance- 6 Minute Walk|Patients will have an exercise tolerance assessment defined as a 6 minute walk completed at cycle 1 (week 1) and cycle 2 (week 5) of treatment and visit 9 (12 weeks) and visit 10 (18 weeks).|Up to 18 weeks from baseline|Data was collected but not analyzed due to the study closing before accrual was met. Below is data on how many patients started 6 minute walk and how many patients stopped before reaching 6 minutes at each time point is shown below.|||participants|||Number
2711302|NCT01163786|Primary|Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline|FEV1 will be measured by spirometry assessments at baseline (pre-transplant baseline - prior to pulmonary chronic graft-versus-host disease (p-CGVHD)) during treatment (10 weeks) and at follow up visit 9 (at 12 weeks) and at follow up visit 10 (at 18 weeks) with patients having spirometry tested up to 6 times from screening to the end of the study. FEV1 is reported as slopes computed by dividing difference in FEV1 by time in months.|Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline||||percentage per month||Full Range|Median
2711303|NCT01163760|Other Pre-specified|Comfort While Working on Computer|"Comfort throughout the day was evaluated via subjective question: Comfort while working on computer and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week-follow-up||||percentage of participants|||Number
2711304|NCT01163760|Secondary|Comfort Throughout the Whole Day|"Comfort throughout the day was evaluated via subjective question: Comfort throughout the whole day and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week follow-up|Subjects analyzed were those enrolled, randomized, and completed the study.|||percentage of participants|||Number
2711305|NCT01163760|Primary|Lens Comfort|"Lens comfort was evaluated via the subjective question: How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? (excellent/very good=5...very good=3...Poor=0)"|1-week follow-up|Subjects analyzed were those who were enrolled, randomized, and completed the study.|||units on a scale||Standard Deviation|Mean
2711347|NCT01163279|Secondary|General Self Efficacy Scale (GSE)|GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Scores on scale||Standard Deviation|Mean
2711306|NCT01163747|Secondary|Number of Participants With Adverse Events Through Week 8|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|8 weeks|All participants who received at least one dose of study treatment were included in the safety evaluation.|||participants|||Number
2711307|NCT01163747|Secondary|Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine. N indicates the number of participants with available data for each serotype. No imputation was performed.|||percentage of participants|||Number
2711308|NCT01163747|Secondary|Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination|Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.|||IU/mL||Standard Deviation|Mean
2711309|NCT01163747|Secondary|Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination|Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.|||mg/L||Standard Deviation|Mean
2711310|NCT01163747|Secondary|Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination|A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels < 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.|||percentage of participants||95% Confidence Interval|Number
2711311|NCT01163747|Secondary|Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.|||percentage of participants||95% Confidence Interval|Number
2711312|NCT01163747|Primary|Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.|||percentage of participants||95% Confidence Interval|Number
2711313|NCT01163721|Primary|Change From Baseline in Fasting Serum Glucose at Week 12|Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Full Analysis Set|||mg/dL||Standard Error|Least Squares Mean
2711314|NCT01163721|Primary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal|2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Error|Least Squares Mean
2711315|NCT01163721|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percent of HbA1c in blood||Standard Error|Least Squares Mean
2711316|NCT01163656|Primary|Time to Tracheal Intubation|The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.|Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.||||seconds||95% Confidence Interval|Median
2711317|NCT01163617|Secondary|Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)||||seconds||90% Confidence Interval|Mean
2711318|NCT01163617|Secondary|Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)||||seconds||90% Confidence Interval|Mean
2711319|NCT01163617|Primary|Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)||||seconds||90% Confidence Interval|Mean
2711320|NCT01163617|Primary|Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector|Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.|Phase A (Week 0 and Week 2)||||cm||Standard Deviation|Mean
2711321|NCT01163604|Secondary|Clinical Endpoints||at one year|||||||
2711322|NCT01163604|Secondary|Various Adverse Effects||at one year|||||||
2711323|NCT01163604|Secondary|NIHSS, mRS|NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.|at one year|||||||
2711324|NCT01163604|Primary|Number of Participants With Occlusion and Restenosis at One Year|Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%|at one year||||participants|||Number
2711325|NCT01163474|Secondary|Feasibility||1 month|Data for this outcome are no longer available.||||||
2711326|NCT01163474|Secondary|Acceptability|Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).|1 month||||units on a scale||Standard Deviation|Mean
2711327|NCT01163474|Primary|Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)|"Using CVT software and desktop webcams on the VA private network, Virtual CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers' CVT decisions to the FTF decision."|1 month||||percentage of agreement|||Number
2711328|NCT01163461|Primary|Speech Production|percent change in the number of untrained words spoken correctly|Baseline to one week post treatment termination and three months post treatment termination||||% change score of untrained real words||Standard Deviation|Mean
2711329|NCT01163318|Secondary|Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit|MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.|Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.|||Percentage of participants|||Number
2711330|NCT01163318|Secondary|Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit|DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score < 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.|Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.|||Percentage of participants|||Number
2711334|NCT01163292|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Weeks 0, 26, and 52|All participants with post-baseline HAQ-DI data, using LOCF imputation method|||units on a scale||Standard Deviation|Mean
2711335|NCT01163292|Secondary|Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52|Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Week 0 to Week 52|All participants with post-baseline mTSS data, using LOCF imputation method|||units on a scale||Standard Deviation|Mean
2711336|NCT01163292|Secondary|Matrix Metalloprotease-3 (MMP-3)|MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)|Weeks 0, 26, and 52|All participants with post-baseline MMP-3 data, using LOCF imputation method|||units on a scale|||Number
2711337|NCT01163292|Primary|Disease Activity Score (DAS28)|The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Weeks 0, 26, and 52|All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2711338|NCT01163279|Secondary|DKEFS Trail Making- Condition 4: Number-letter Switching|DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Time in seconds||Standard Deviation|Mean
2711339|NCT01163279|Secondary|DKEFS Word Fluency|This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Number of words generated||Standard Deviation|Mean
2711340|NCT01163279|Secondary|DKEFS Tower Test- Achievement Score|This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
2711341|NCT01163279|Secondary|Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time|This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Time in seconds||Standard Deviation|Mean
2711342|NCT01163279|Secondary|Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||number of visits||Standard Deviation|Mean
2711343|NCT01163279|Secondary|Stanford Patient Education Research Center- Communication With Physicians Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
2711344|NCT01163279|Secondary|Stanford Patient Education Research Center- Physical Activity Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||hours of physical activity/week||Standard Deviation|Mean
2711345|NCT01163279|Secondary|Stanford Patient Education Research Center- Health Distress Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
2711346|NCT01163279|Secondary|Stanford Patient Education Research Center- General Health Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
2711348|NCT01163279|Primary|Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)|COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.|Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||percentage of untrained goals improved|Total number of goals||Number
2711349|NCT01163266|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2711350|NCT01163266|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
2711351|NCT01163266|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~The HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2711352|NCT01163266|Secondary|Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects.|Week 8|Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2711353|NCT01163266|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
2711354|NCT01163266|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2711355|NCT01163253|Secondary|Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)|Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2711356|NCT01163253|Secondary|Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)|EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711761|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36||||percentage of drop seizures||Full Range|Median
2711357|NCT01163253|Secondary|Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores|EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711358|NCT01163253|Secondary|"Number of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear"|"The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as clear (score of 0) or almost clear (score of 1) in PtGA at each specified visit were reported in this outcome measure."|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||participants|||Number
2711359|NCT01163253|Secondary|36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores|The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711360|NCT01163253|Secondary|36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores|The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711361|NCT01163253|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48|The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.|Baseline, Month 1, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711362|NCT01163253|Secondary|Dermatology Life Quality Index (DLQI) Scores|The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.|Baseline, Month 1, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711363|NCT01163253|Secondary|Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48|ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711364|NCT01163253|Secondary|Itch Severity Item (ISI) Scores|ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711365|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2711366|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2711367|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2711368|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711369|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711370|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711371|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Scaling|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711372|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Induration|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711373|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Erythema|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711374|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711375|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2711388|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2711389|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2711376|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2711377|NCT01163253|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.|Month 1, 3, 6, 12, 24, 36, 48|Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies participants evaluable for this outcome measure and ‘n’ signifies participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2711378|NCT01163253|Primary|Number of Participants With Malignancy Events|Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2711379|NCT01163253|Primary|Number of Participants With Adjudicated Cardiovascular Events|Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2711380|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
2711381|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
2711382|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
2711383|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
2711384|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||milliseconds (msec)||Standard Deviation|Mean
2711385|NCT01163253|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2711386|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2711387|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2711392|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||beats per minute||Standard Deviation|Mean
2711393|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2711394|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2711395|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2711396|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2711397|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2711398|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2711399|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2711400|NCT01163253|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||participants|||Number
2711401|NCT01163253|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2711402|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
2711403|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||IU/L||Standard Deviation|Mean
2711404|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
2711405|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
2711406|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
2711762|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36||||percentage of drop seizures||Full Range|Median
2711407|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
2711408|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||international unit per liter (IU/L)||Standard Deviation|Mean
2711409|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2711410|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2711411|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2711412|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2711413|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2711414|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2711415|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2711416|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
2711417|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
2711418|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
2711419|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
2711420|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
2711421|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
2711808|NCT01160380|Primary|BFI Score|Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10|Day 1, Day 28 and Day 56||||units on a scale||Standard Deviation|Mean
2711422|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||1000 cells/mm^3||Standard Deviation|Mean
2711423|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
2711424|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
2711425|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
2711426|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
2711427|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
2711428|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
2711429|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2711430|NCT01163253|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2711431|NCT01163253|Primary|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||adverse events|||Number
2711432|NCT01163253|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2711433|NCT01163214|Secondary|Number of Subjects Who Experienced Neurological Changes Postoperatively|Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.|6 weeks postoperative|The number of participants analyzed in the nerve block arm varied because data were not available for all participants in all neurological categories. The sample size for the periarticular injection arm was 79 because neurological data were not collected on 2 participants.|||participants|||Number
2711434|NCT01163214|Secondary|Length of Stay in Hospital|Length of stay data were calculated from the medical record.|Approximately 2 days after surgery|The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants.|||days||Standard Deviation|Mean
2711435|NCT01163214|Secondary|Straight-leg Raise|Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.|Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon|The number of participants analyzed varied at each category time point because either data points were missing for participants, or as the condition of the participants improved, they were discharged from the hospital. Number of participants per arm for each time point is shown in each category label.|||participants|||Number
2711438|NCT01163214|Secondary|Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|In the nerve block arm 5 subjects were excluded (3 subjects were not treated as planned, and 1 subject received a sciatic catheter instead of a single injection, and 1 subject previously had a nerve block procedure.) In the periarticular injection arm 4 patients were excluded (3 subjects were not treated as planned, and 1 subject was too heavy.)|||units on a scale||Standard Deviation|Mean
2711439|NCT01163162|Primary|24-hour Urine Creatinine Excretion Rate|We expect the 24 hour urine creatinine excretion rate to show no differences between groups.|1 Week||||mg/24hour/day||95% Confidence Interval|Mean
2711440|NCT01163162|Secondary|Serum Creatinine|We expect serum creatinine to confirm the results of creatinine clearance.|1 Week||||mg/dl/day||95% Confidence Interval|Mean
2711441|NCT01163162|Secondary|Creatinine Clearance|The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.|1 Week||||ml/min||95% Confidence Interval|Mean
2711442|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Mineralization Lag Time|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Mineralization Lag Time (days). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)|||days||Standard Deviation|Mean
2711443|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Thickness|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Thickness (um). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)|||um||Standard Deviation|Mean
2711444|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Volume/Bone Volume|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Volume/Bone Volume (%). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)|||percentage of volume||Standard Deviation|Mean
2711445|NCT01163149|Secondary|Change in Walking Ability as Measured by the Six-Minute Walk Test (6MWT)|The patient was instructed to walk the length of a pre-measured hallway for 6 minutes. The primary measurement was distance walked (in meters).|Baseline, Week 24 (primary treatment period) and up to 288 weeks of asfotase alfa exposure|Full analysis set (intent-to-treat, all randomized patients). Among the 6 control subjects, only 4 had both a Baseline and Week 24 value.|||meters||Standard Deviation|Mean
2711446|NCT01163149|Secondary|Change From Baseline in Bone Mineral Density (BMD) as Measured by Dual-energy X-ray Absorptiometry (DXA)|A DXA scan was performed to evaluate bone bone mineral density (BMD) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks).|Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.|Full analysis set (intent-to-treat, all randomized patients)|||g/cm2||Standard Deviation|Mean
2711447|NCT01163149|Secondary|Change From Baseline in Bone Mineral Content (BMC) as Measured by Dual-energy X-ray Absorptiometry (DXA)|A DXA scan was performed to evaluate bone mineral content (BMC) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks).|Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.|Full analysis set (intent-to-treat, all randomized patients)|||g||Standard Deviation|Mean
2711448|NCT01163149|Primary|Safety and Tolerability of Asfotase Alfa|The safety and tolerability of daily subcutaneous (SC) injections of asfotase alfa was assessed by routine monitoring of patients for treatment-emergent adverse events (TEAEs) and injection-associated reactions (IARs).|Up to 288 weeks exposure to asfotase alfa|Safety Set. Control group and asfotase alfa Cohorts during the primary treatment period (first 24 weeks of study); all patients with asfotase alfa exposure during open-label extension treatment period.|||Number of Treatment-Emergent Events|||Number
2711449|NCT01163149|Primary|Change From Baseline to Week 24 for Plasma Inorganic Pyrophosphate (PPi)|Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma inorganic pyrophosphate (PPi)|Baseline, Week 24|Full analysis set (intent-to-treat, all randomized patients)|||uM||Standard Deviation|Mean
2711450|NCT01163149|Primary|Change From Baseline to Week 24 for Plasma Pyridoxal-5' Phosphate (PLP)|Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma pyridoxal-5' phosphate (PLP)|Baseline, Week 24|Full analysis set (intent-to-treat, all randomized patients)|||ng/mL||Standard Deviation|Mean
2711451|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711452|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711453|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711454|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711455|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711456|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711457|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
2711458|NCT01163097|Secondary|Subject Incidence of Proteinuria|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.~Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||participants|||Number
2711459|NCT01163097|Secondary|Subject Incidence of Treatment-emergent Adverse Event|Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C)|||participants|||Number
2711460|NCT01163097|Secondary|Palifermin PK Parameters: Vss|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||mL/Kg||Geometric Coefficient of Variation|Geometric Mean
2711461|NCT01163097|Secondary|Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2711462|NCT01163097|Secondary|Palifermin PK Parameters: C0|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2711463|NCT01163097|Secondary|Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2711464|NCT01163097|Secondary|Palifermin PK Parameters: AUC (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2711465|NCT01163097|Secondary|Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2711466|NCT01163097|Secondary|Palifermin PK Parameters: CL|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
2711467|NCT01163097|Secondary|Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics (PK) population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
2711468|NCT01163097|Primary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||95% Confidence Interval|Geometric Mean
2711469|NCT01163097|Primary|Ratio to Baseline of Lipase.|Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.|||ratio||95% Confidence Interval|Geometric Mean
2711470|NCT01163097|Primary|Ratio to Baseline of Amylase|Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.|||ratio||95% Confidence Interval|Geometric Mean
2711471|NCT01163097|Primary|Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.|"Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.~The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)"|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.|||proportion of participants|||Number
2711472|NCT01163097|Primary|Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.|This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.|Day 4|The pharmacodynamic population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C) and had both baseline and Day 4 buccal biopsy samples collected. This analysis was only performed for Treatment A relative to Treatment B as per study plan.|||ratio||90% Confidence Interval|Geometric Mean
2711473|NCT01163084|Other Pre-specified|Proportion of Patients Expressing Differences in Hedgehog, Androgen Signaling and Related Genes Markers||Up to 8 years|||||||
2711474|NCT01163084|Other Pre-specified|Differences in Relapse Rates by Bone Scan/Computed Tomography Scan (Objective)|Will be descriptively summarized.|Baseline to up to 8 years|||||||
2711475|NCT01163084|Other Pre-specified|Differences in the Rate of Positive Surgical Margins Between the Two Groups|Will be descriptively summarized.|Baseline to up to 8 years|||||||
2711476|NCT01163084|Other Pre-specified|Proportion of Patients With PSA =< 0.2 ng/mL|Will be descriptively summarized.|Up to 8 years|||||||
2711477|NCT01163084|Other Pre-specified|Time to PSA (Clinical) Progression, Defined as a Serial Rise in PSA Concentration in the Presence of Castrate Serum Testosterone Concentration or Radiographic Evidence of Progression|Will be descriptively summarized. PSA recurrence is defined as two (2) serial measureable rises in PSA concentration above the undetectable level with the standard assay (> 0.1 ng/mL).|From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years|||||||
2711478|NCT01163084|Other Pre-specified|Time to PSA (Biochemical) Progression, Defined as PSA Recurrence|Will be descriptively summarized. PSA recurrence is defined as two (2) serial measureable rises in PSA concentration above the undetectable level with the standard assay (> 0.1 ng/mL).|From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years|||||||
2711479|NCT01163084|Other Pre-specified|Differences in Relapse Rates by PSA Levels (Biochemical)|Will be descriptively summarized.|Date of surgery, then every 6 months, up to 8 years|||||||
2711480|NCT01163084|Primary|Proportion of Patients With =< 5% Tumor Involvement|Each patient's pathologic staging will be assessed from the samples collected from prostatectomy. Will be descriptively summarized. Two-sided Chi-Square test will be used to provide the test of significance between the 2 groups of LHRHa versus LHRHa plus vismodegib.|Baseline up to 4 months or radical prostatectomy, whichever comes first|Results was not determined.||||||
2711481|NCT01163032|Secondary|Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)|Adverse events were recorded in the source documents from the time of the patient's informed consent signature until the end of the patient's study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment.|6 months|One subject who rolled into the OLE from the randomized phase (tasimelteon) experienced an unrelated TEAE during the OLE phase.|||participants|||Number
2711482|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 2 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
2711483|NCT01163032|Post-Hoc|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 45 Minutes) and UQ-dTSD (≤ 45 Minutes)|Responder analysis with responder defined as an increase of 45 minutes or more in (LQ-nTST) and a decrease of 45 minutes or more in (UQ-dTSD).|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
2711484|NCT01163032|Secondary|Average Midpoint of Sleep (MoST)|Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||minutes||Standard Error|Mean
2711485|NCT01163032|Secondary|Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)|UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (~ 6 weeks). Lower number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||minutes||Standard Error|Mean
2711486|NCT01163032|Secondary|Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)|LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (~ 6 weeks). The higher number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||minutes||Standard Error|Mean
2711487|NCT01163032|Secondary|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)|The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
2711488|NCT01163032|Secondary|Average Clinical Global Impression of Change (CGI-C)|CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement.|Day 112 and 183|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||score||Standard Error|Mean
2711489|NCT01163032|Secondary|Proportion of Patients Entrained as Assessed by Urinary Cortisol|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.|||percentage of patients|||Number
2711490|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
2711491|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 2 on the Non-24 Clinical Response Scale (N24CRS) which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline~For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
2711492|NCT01163032|Primary|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline~For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
2711493|NCT01163032|Primary|Proportion of Patients Entrained as Assessed by Urinary aMT6|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.|||percentage of patients|||Number
2711494|NCT01162863|Secondary|Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index|Change in the motility index defined as the natural log [(sum of pressure amplitudes times the number of contractions) + 1] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days||||units on a scale||Standard Deviation|Mean
2711495|NCT01162863|Secondary|Change in Small Bowel pH and Colon pH From Baseline|Change in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days||||pH||Standard Deviation|Mean
2711496|NCT01162863|Primary|Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline|Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm|21-28 days||||hours||Standard Deviation|Mean
2711497|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 12 Hours|Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL|12 hours||||percentage of participants|||Number
2711498|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 36 Hours|The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.|36 hours||||percentage of participants|||Number
2711499|NCT01162551|Secondary|Number of Dose Adjustments To Maintain Trough Levels|One goal of this study is to maintain trough levels of sirolimus within a certain range. The outcome measure counts the number of dose adjustments up or down that were needed to meet goal level based on weekly tough level measurements.|Day 28|3 patients had weekly sirolimus levels analyzed.|||Dose level adjustments|blood samples||Number
2711500|NCT01162551|Primary|Response Rate|Number of participants who achieve a Complete Response (CR), Complete Response with in the absence of total platelet recovery (CRp), or Partial Response (PR). Per response criteria in this protocol: Complete Response (CR) - M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and recovery of peripheral blood counts (absolute neutrophil count (ANC)> 500/μL and platelets > 50,000/ μL); Complete Response in the absence of total platelet recovery (CRp) - M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease with recovery of peripheral blood counts except for platelets (ANC> 500/μL, platelets < 50,000uL); and Partial Response (PR) - M2 bone marrow (5% but <25% blasts), with no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts (ANC > 500/μL and platelets >50,000/μL).|Day 28||||participants|||Number
2711745|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 12|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711501|NCT01162499|Secondary|Peak Glucagon Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various 3 hours after the start of the infusion. The mean peak glucagon concentration for both Exendin-(9-39) doses were compared with the peak glucagon during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences in peak glucagon concentration were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||pg/ml||Standard Error|Mean
2711502|NCT01162499|Secondary|Peak Plasma Glucagon-like Peptide-1 (GLP-1) Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon-like peptide-1 levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion. The mean peak glucagon-like peptide-1 concentration for both Exendin-(9-39) doses were compared with the peak glucagon-like peptide-1 during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||pmol/l||Standard Error|Mean
2711503|NCT01162499|Secondary|Mean Acetaminophen Plasma Concentration Area Under the Curve (AUC 0-3h)|The effect of gastric emptying was examined using the acetaminophen method whereby acetaminophen (30mg/kg or maximum of 1500mg) was mixed into the Pediasure/formula during the meal tolerance testing. Blood samples were collected every 30 minutes and the absorption of acetaminophen was determined by the gastric emptying rate, as the serum concentrations correlate with gastric emptying of liquids. Mean acetaminophen levels for each group at each time point were used to calculate the Area Under the Concentration versus Time Curve (AUC expressed in μg*min/l) after the consumption of formula for each of the two Exendin-(9-39) dose levels and normal saline vehicle.|3 hours|AUC were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||μg*min/l||Standard Error|Mean
2711504|NCT01162499|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||pmol*min/l||Standard Error|Mean
2711505|NCT01162499|Primary|Mean Plasma Glucose Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma glucose levels samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||mg*min/dl||Standard Error|Mean
2711506|NCT01162486|Secondary|Rifapentine Concentrations From Dried Blood Spots|To develop methods for determination of rifapentine concentrations from dried blood spots on sampling paper|days 2, 3, 7, 10, 15, 16, 17, 18|This outcome was not assessed because data was not collected||||||
2711507|NCT01162486|Secondary|Transporter Genes|To determine the effects of polymorphisms of transporter genes on rifampin and rifapentine PK parameters|day 3|This outcome was not assessed because data was not collected||||||
2711508|NCT01162486|Secondary|Midazolam, AUC Over 12 Hours Post-dose|To compare and describe, the pharmacokinetics of single-dose midazolam alone (Day 1) versus midazolam co-administered with either steady-state rifapentine at multiple daily doses (5, 10, 15, and 20 mg/kg) or rifampin at 10 mg/kg daily (Day 15)|days: 1, 15|29 participants completed both midazolam PK visits; one person in RPT1 visit was not analyzed because his samples were zero and was found to have been non-compliant with regimen|||ng*h/ml||Full Range|Median
2711509|NCT01162486|Primary|Pharmacokinetics (AUC of RPT Over 24 Hours Post-dose)|To determine and compare the steady-state pharmacokinetics and dose linearity of escalating daily doses of rifapentine in dose cohorts of 5 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg in healthy volunteers after a single dose (Day 2) or multiple doses (Day 15)|days: 2, 15|These patients completed PK visits on Day 2 and 15 (Three participants in this non-control group - subdivided into 4- did not complete the study). Reasons provided in the participant flow session|||(mcg*h/ml)||Full Range|Median
2711510|NCT01162486|Primary|Number of Participants With Grade 2 or Higher Adverse Events Over the Course of the 26 Day Trial|Number of Participants with Grade 2 or higher adverse events over 26 days|26 days|Four withdrew prior to receiving study rifamycin so were not included in the safety population|||Participants|||Count of Participants
2711511|NCT01162473|Primary|Number of Subjects Who Completed Desensitization Protocol|"Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be treatment failures. Subjects who completed the desensitization protocol were considered to be treatment successes."|1 year|The analysis population included all subjects who began desensitization per protocol.|||participants|||Number
2711560|NCT01162122|Secondary|Number of Subjects Reporting Solicited Adverse Events Following Vaccination|The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.|Day 1 through Day 7 post vaccination|Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.|||participants|||Number
2711512|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.|||Canadian dollars||Standard Deviation|Mean
2711513|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.|||Canadian dollars||Standard Deviation|Mean
2711514|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=2, 3 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).|||percentage of participants|||Number
2711515|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=11, 10 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).|||percentage of participants|||Number
2711516|NCT01162421|Secondary|HCR: Medical Insurance at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC).|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=26, 26 is the number of participants who answered that they did have health insurance).|||percentage of participants|||Number
2711517|NCT01162421|Secondary|Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC).|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=25, 28 is the number of participants who answered that they did have health insurance).|||percentage of participants|||Number
2711518|NCT01162421|Secondary|Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24|"Participants measured their satisfaction with care by specifying their in response to the question How satisfied are you with the results of your RA treatment? on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711519|NCT01162421|Secondary|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711520|NCT01162421|Secondary|Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711561|NCT01162122|Secondary|All Cause Mortality Rate, Across Vaccine Groups|The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).|||participants|||Number
2711521|NCT01162421|Secondary|Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state).|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2711522|NCT01162421|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24|The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2711523|NCT01162421|Secondary|Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711524|NCT01162421|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711525|NCT01162421|Secondary|Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving HAQ < 0.5. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711526|NCT01162421|Secondary|Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711527|NCT01162421|Secondary|Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24|HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711538|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||tender joints||Standard Error|Least Squares Mean
2711528|NCT01162421|Secondary|Percentage of Participants With Flare-Up After Remission by Month 24|Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 < 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment.|||percentage of participants|||Number
2711529|NCT01162421|Secondary|Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and < 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or an improvement (decrease) in the DAS28 of ≥ 1.2 from Baseline and attainment of a DAS28 score of > 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711530|NCT01162421|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of ≥ 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711531|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) low disease activity was defined as DAS28(CRP) < 3.2. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711532|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) remission was defined as DAS28(CRP) < 2.6. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
2711533|NCT01162421|Secondary|Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2711534|NCT01162421|Secondary|Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24||Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||mg/L||Standard Error|Least Squares Mean
2711535|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how severe their pain had been in the previous week on a VAS from 0 (no pain) to 100 (pain as bad as it could be). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711536|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how they were doing with their RA on a VAS from 0 (very well) to 100 (very poorly). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711537|NCT01162421|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Physicians were asked to indicate the participant's disease activity (independent of the participant's self assessment) on a visual analogue scale (VAS) from 0 (very good) to 100 (very bad). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2711557|NCT01162304|Secondary|Brief Pain Inventory|Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
2711593|NCT01161862|Secondary|Number of Carbohydrate Interventions for Hypoglycemia||48 hours|Overall number of participants=24 (12 in each arm)|||Carbohydrate Interventions|||Number
2711539|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-68, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||tender joints||Standard Error|Least Squares Mean
2711540|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||swollen joints||Standard Error|Least Squares Mean
2711541|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-66, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||swollen joints||Standard Error|Least Squares Mean
2711542|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR70 responder if the following 3 criteria for improvement from Baseline are met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: -~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
2711543|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR50 responder if the following 3 criteria for improvement from Baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
2711544|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR20 responder if the following 3 criteria for improvement from Baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: -~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein [CRP])."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
2711545|NCT01162421|Secondary|Percentage of Participants With Rapid Radiographic Progression at Month 12|Radiographic progression was defined as a change from Baseline in mTSS that is ≥ 5 units. The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug ith an assessment (nonresponder imputation).|||percentage of participants|||Number
2711546|NCT01162421|Secondary|Change From Baseline in mTSS at Months 6, 12 and 24|The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 12, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug; n=number of participants with an assessment at Baseline and given timepoint (observed cases).|||units on a scale||Standard Error|Least Squares Mean
2711558|NCT01162304|Primary|Numerical Pain Rating Scale (NRS)|The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.|Daily|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
2711559|NCT01162135|Primary|Rate of Positive PSADT Outcome|Proportion of patients at 6 months post-treatment with a PSADT >= 200% from baseline|6 months after treatment with digoxin||||participants|||Number
2711547|NCT01162421|Secondary|Percentage of Participants With No Radiographic Progression at Month 6 and Month 24|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
2711548|NCT01162421|Primary|Percentage of Participants With No Radiographic Progression at Month 12|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF): missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||percentage of participants|||Number
2711549|NCT01162382|Secondary|fCMRI Results|Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.|At study entry and within 2 days of exiting 4 weeks of rTMS treatment|No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.||||||
2711550|NCT01162382|Primary|Hamilton Depression Rating Scale-24 Point Version (HDRS-24)|HDRS-24 will be used to measure response to rTMS treatment. A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.|At study entry and within 2 days of exiting 4 weeks of rTMS treatment|No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.||||||
2711551|NCT01162343|Primary|Delirium|Delirium was diagnosed by a consultation-liaison psychiatrist assessment using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The psychiatrists performed a battery of bedside cognitive tests, including (but not limited to) Clock Drawing Test, Luria hand sequencing task, and tests for verbal fluency. A focused neurological examination (i.e., screening for paraphasic errors, tremors, tone, asterixis, frontal release signs etc.,) and evaluation for affective lability, hallucinations, and level of alertness were also conducted routinely. Confrontational naming, proverb interpretation or similarities, and assessments for apraxias were performed at the discretion of the reference psychiatrists, especially if the diagnosis of delirium was inconclusive.|Within 3 hours of the study assessments.||||percent||95% Confidence Interval|Number
2711552|NCT01162317|Secondary|Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency|Wrist actigraphy is a non-invasive method of continuously monitoring gross body activities when a watch-like actimetry sensor is worn at the non-dominant wrist. An algorithm has been developed to assess sleep/wake behavior. Specifically in this study, we used Respironics® actiwatches for data collection. Subjects were asked to wear the actiwatches for a consecutive week at baseline and then at post-intervention, and the actiwatches were taken off only during showers. Wrist actigraphy was examined in association with sleep diary the subjects were to keep for the weeks of monitoring. Threshold-based method algorithm for data interpretation was provided by Respironics® Actiware Software. Medium level threshold was set to detect Wake and Sleep; sleep interval detection algorithm was set for 3 minutes of immobile minutes for Sleep Onset and 5 minutes of immobile minutes for Sleep End. Sleep efficiency is sleep duration divided by total bed time (both in minutes), times 100%.|pre-intervention, post-intervention (1wk of recording each)|All obtained actigraphy data were analyzed. This form doesn't allow specific indication of sample sizes. Therefore, here overall numbers of participants analyzed were the same as the maximal potential.|||percentage||Standard Deviation|Mean
2711553|NCT01162317|Primary|PSQI Change|"change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.~The PSQI global score has a possible range of 0-21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition."|Baseline and post-intervention||||change of points from baseline||Standard Deviation|Mean
2711554|NCT01162304|Secondary|Patient Global Impression of Change|This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.|Visits 4 and 6 the end of each of the two treatment periods|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
2711555|NCT01162304|Secondary|Short Form Health Survey (SF-36)|It is a 36-item questionnaire designed to measure general health related quality of life.|Visits 2, 4 and 6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
2711556|NCT01162304|Secondary|Hospital Anxiety and Depression Scale|The HADS will be administered to assess anxiety and depression.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
2711594|NCT01161862|Secondary|Insulin Total Daily Dose||48 hours|Overall number of participants=24 (12 in each arm)|||u/kg/day||Standard Deviation|Mean
2711562|NCT01162122|Secondary|Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups|The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).|||participants|||Number
2711563|NCT01162122|Secondary|Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups|The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness) population.|||participants|||Number
2711564|NCT01162122|Secondary|Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups|The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.|Day 22 through Day 366 post vaccination|Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.|||participants|||Number
2711565|NCT01162122|Secondary|Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains|"The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset.|||Percentage of subjects||95% Confidence Interval|Number
2711566|NCT01162122|Secondary|Persistence of GMTs Against Homologous and Heterologous Strains|The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.|||Titers||95% Confidence Interval|Geometric Mean
2711567|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS|||Percentage of subjects||95% Confidence Interval|Number
2711568|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on PPS.|||Percentage of subjects||95% Confidence Interval|Number
2711569|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.|Day 22 post vaccination|Analysis was done on FAS.|||Titers||95% Confidence Interval|Geometric Mean
2711570|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .|Day 22 post vaccination|Analysis was done on PPS.|||Titers||95% Confidence Interval|Geometric Mean
2711571|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on FAS.|||Percentage of subjects||95% Confidence Interval|Number
2711572|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
2711573|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
2711574|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
2711575|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS population.|||Titers||95% Confidence Interval|Geometric Mean
2711576|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.|||Percentage of subjects||95% Confidence Interval|Number
2711577|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS|The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.|||Titers||95% Confidence Interval|Geometric Mean
2711578|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS|||Ratio||95% Confidence Interval|Geometric Mean
2711579|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
2711580|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
2711581|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS.|||Percentage of subjects||95% Confidence Interval|Number
2711582|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)|The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22|||Titers||95% Confidence Interval|Geometric Mean
2711583|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.|||Percentage of subjects||95% Confidence Interval|Number
2711584|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.|||Titers||95% Confidence Interval|Geometric Mean
2711585|NCT01162122|Primary|Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV|Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.|Day 22 post vaccination|Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.|||Titers||95% Confidence Interval|Geometric Mean
2711586|NCT01162096|Secondary|Immune Reconstitution||Up to 5 years||||cells/ul||Full Range|Median
2711587|NCT01162096|Secondary|Number of Participants With Successful Engraftment||6 months|32 patients are evaluable for engraftment|||Participants|||Count of Participants
2711588|NCT01162096|Primary|Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning|Number of patients alive at 6 months post-transplant|6 months||||Participants|||Count of Participants
2711589|NCT01162005|Secondary|Duration of Remission|Mean duration of remission|12-month treatment period||||months||Standard Deviation|Mean
2711590|NCT01162005|Primary|Remission Rate|Complete remission at 12 months Per KDIGO clinical practice guideline for glomerulonephritis (2012): Complete remission (CR), urine protein creatinine ratio below 200mg/g (20mg/mmol) or 1+ of protein on urine dipstick for 3 consecutative days|12-month treatment period||||Participants|||Count of Participants
2711591|NCT01161862|Secondary|Nadir Blood Glucose in Each Arm||48 hours||||mg/dl||Standard Deviation|Mean
2711592|NCT01161862|Secondary|Number of Blood Glucose Events < 70 mg/dl||48 hours||||Number of events|||Number
2711599|NCT01161771|Secondary|Change From Baseline in Schirmer's Test at Month 3|Change from baseline in Schirmer's Test result at month 3. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Millimeters of Tears||Standard Deviation|Mean
2711600|NCT01161771|Secondary|Change From Baseline in Tear Break-Up Time at Month 3|Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Seconds||Standard Deviation|Mean
2711601|NCT01161771|Secondary|Change From Baseline in Conjunctival Staining at Month 3|Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Scores on a Scale||Standard Deviation|Mean
2711602|NCT01161771|Secondary|Change From Baseline in Corneal Staining at Month 3|Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Scores on a Scale||Standard Deviation|Mean
2711603|NCT01161771|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3|Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Scores on a Scale||Standard Deviation|Mean
2711604|NCT01161771|Primary|The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured|The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.|Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Percentage of Subjects|||Number
2711605|NCT01161628|Secondary|Incidence of Non-relapse Mortality||2 years||||percentage of patients|||Number
2711606|NCT01161628|Secondary|Incidence of Disease-free Survival||2 years|Of the surviving patients at 2 years (82% of initial enrolled population)|||percentage of patients|||Number
2711607|NCT01161628|Secondary|Duration of Systemic Corticosteroid Use||2 years|Only 2 patients out of the 22 evaluable patients enrolled received steroids during the course of treatment for cGVHD. A total of 25 patients were enrolled; 3 patients were excluded from this analysis due to treatment failure.|||days||Full Range|Median
2711608|NCT01161628|Primary|Rate of Partial Response of cGVHD to Treatment||2 years||||percentage of patients|||Number
2711609|NCT01161628|Primary|Rate of Overall Response of cGVHD to Treatment||2 years||||percentage of patients|||Number
2711610|NCT01161628|Secondary|Incidence of Overall Survival||2 years||||percentage of patients|||Number
2711611|NCT01161628|Secondary|Time to Immunosuppression Withdrawal||2 years||||days||Full Range|Median
2711612|NCT01161628|Secondary|Requirement for Systemic Corticosteroid Use||2 years|20 out of the 25 patients enrolled received no corticosteroids at all during the course of treatment for cGVHD|||participants|||Number
2711613|NCT01161628|Primary|Rate of Complete Response of cGVHD to Treatment.||2 years||||percentage of patients|||Number
2711614|NCT01161563|Secondary|Discomfort From Injection|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.|||units on a scale||95% Confidence Interval|Mean
2711615|NCT01161563|Primary|Patient Bother From Injection Site Burning and/or Stinging|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.|||units on a scale||95% Confidence Interval|Mean
2711746|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 8|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711616|NCT01161537|Secondary|Part B: Absolute Change From Baseline in in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Week 48|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2711617|NCT01161537|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 48|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||mmol/L||Standard Deviation|Mean
2711618|NCT01161537|Secondary|Part B: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 48|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||percent predicted of FEV1||Standard Deviation|Mean
2711619|NCT01161537|Secondary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part B: Day 1 up to Week 48|Safety Set for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part B.|||participants|||Number
2711620|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Day 43|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||units on a scale||Standard Deviation|Mean
2711621|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Sweat Chloride at Day 43|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2711622|NCT01161537|Secondary|Part A: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Day 43|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||percent predicted of FEV1||Standard Deviation|Mean
2711623|NCT01161537|Secondary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part A: Day 1 up to Day 57|Safety Set for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A. Data was reported as per the intervention received (Placebo [Placebo Run in/Washout] or VX-770 [VX-770 Treatment]).|||participants|||Number
2711624|NCT01161537|Primary|Part B: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Week 48|Subjects were asked to inhale hyperpolarized 3 He gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid MRI was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B.|||percentage of total lung volume||Standard Deviation|Mean
2711625|NCT01161537|Primary|Part A: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Day 43|Subjects inhaled hyperpolarized helium-3 (3He) gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid magnetic resonance imaging (MRI) was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He-MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||percentage of total lung volume||Standard Deviation|Mean
2711626|NCT01161524|Secondary|Change From Baseline to End of Treatment (EOT) for the Tanner Stage|The effect of perampanel on growth and development in adolescents (male and female), including sexual development was measured using Tanner scale. The scale defined physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitals, testicular volume and development of pubic hair. Tanner scale consisted of 5 scales from I to V (1: pre-pubertal to 5: adult). Data is reported as the change from Baseline to End of Treatment for the Tanner Stage.|From Baseline up to Week 52 or EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)|SAS (Extension Phase)|||participants|||Number
2711627|NCT01161524|Secondary|Mean Change From Baseline in Bone Age Minus Age (Months) From Hand X-ray (Extension Phase)|"Bone age was measured using hand X-ray. The mean change from Baseline in bone age (months) minus age (months) from the hand x-ray was assessed. + means bone age is older than age and - means bone age is younger than age."|From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)|The Safety Analysis Set consisted of all enrolled subjects who (1) took at least 1 dose of perampanel in the Extension Phase and (2) had a safety assessment after the first dose of perampanel in the Extension Phase.|||Months||Standard Deviation|Mean
2711628|NCT01161524|Secondary|Change From Baseline to End of Treatment in Time to Complete Lafayette Grooved Pegboard Test (LGPT) (Extension Phase)|The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD.|From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)|FAS for cognition (Extension Phase)|||Seconds||Standard Deviation|Mean
2711629|NCT01161524|Secondary|Change From Baseline to End of Treatment in Controlled Oral Word Association Test Scores (COWAT) (Extension Phase)|The COWAT test measured the executive function of the frontal lobe and consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of 2 parts which included the Letter Fluency task and the Category Fluency task. For the Letter Fluency task, the participant was given one minute to list as many words as they could which began with a given letter from the following set of 3 letters: F, A, and L. The number of correct words from the 3 sets comprised the Letter Fluency score. For the Category Fluency task, the participant was given one minute to list as many words as they could which belonged to a given category. The number of correct words comprised the Category Fluency score. Total score was calculated as sum of acceptable words generated. The scale ranged from 0-90, with higher scores indicating improvement in language.|From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)|FAS for cognition (Extension Phase)|||Scores on a scale||Standard Deviation|Mean
2711630|NCT01161524|Secondary|Mean Change From Baseline in CDR System Domain T-Score Over Time: Speed of Memory (Extension Phase)|The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.|Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52|FAS for cognition (Extension Phase)|||T-score||Standard Deviation|Mean
2711631|NCT01161524|Secondary|Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Working Memory (Short Term) (Extension Phase)|The cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for participants with exposure of more than 9 weeks, Week 19 for participants with exposure of more than 19 weeks, Week 30 for participants with exposure of more than 26 weeks, Week 39 for participants with exposure of more than 39 weeks, and Week 52 for participants with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.|Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52|FAS for cognition (Extension Phase)|||T-score||Standard Deviation|Mean
2711747|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711632|NCT01161524|Secondary|Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Episodic Secondary Memory (Extension Phase)|The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.|Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52|FAS for cognition (Extension Phase)|||T-score||Standard Deviation|Mean
2711633|NCT01161524|Secondary|Mean Change From Baseline in CDR System Domain T-Score Over Time: Continuity of Attention (Extension Phase)|The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.|Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52|FAS for cognition (Extension Phase)|||T-score||Standard Deviation|Mean
2711634|NCT01161524|Secondary|Mean Change From Baseline in CDR System Domain T-Score Over Time: Power of Attention (Extension Phase)|The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.|Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52|FAS for cognition (Extension Phase)|||T-score||Standard Deviation|Mean
2711635|NCT01161524|Secondary|Mean Change From Baseline by Visits in CDR System Domain T-Scores (Extension Phase)|The Cognitive measure scores are presented as T-Scores. T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. Wk = Week and EOT=End of Treatment. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.|Baseline, Week 9, Week 19, Week 30, Week 39, Week 52, and EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)|FAS for cognition (Extension Phase)|||T-score||Standard Deviation|Mean
2711636|NCT01161524|Secondary|Mean Change From Baseline in CDR System Global Cognition Score Over Time (Extension Phase)|The CDR System Global Cognitive was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). Domain scores were normalized to mean of 50 and SD of 10 before taking the average. The scale ranged from 0 to 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. The data is presented as CDR System Global Cognitive scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks).|Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52|FAS for Cognition (Extension Phase)|||Scores on a scale||Standard Deviation|Mean
2711637|NCT01161524|Secondary|Mean Change From Baseline to End of Treatment in Cognition Drug Research (CDR) System Global Cognition Score (Extension Phase)|The CDR System Global Cognitive was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). Domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 to 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.|Baseline, Week 9, Week 19, Week, 30, Week 39, Week 52, and End of Treatment (defined as the last nonmissing value after date of first perampanel dose up to 14 days after date of last dose)|The Full Analysis Set for Cognition consisted of all randomized subjects who received study drug in the Extension Phase, had baseline cognition data, and had at least 1 postdose CDR System cognitive test battery assessment after Week 27.|||Scores on a scale||Standard Deviation|Mean
2711676|NCT01161420|Secondary|Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months|The Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject's daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
2711638|NCT01161524|Secondary|Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency Over the Perampanel Duration Exposure (Extension Phase)|A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from pre-perampanel. The percentage of responders from Week 1 of perampanel treatment through successive 13-week intervals (Weeks 1 to 13 for subjects with any data, Weeks 1 to 26 for subjects with exposure of more than 13 weeks, Weeks 1 to 39 for subjects with exposure of more than 26 weeks, and Week 1 to 52 for subjects with exposure of more than 52 weeks) are presented. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.|Week 1-13, Week 14-26, Week 27-39, and Week 40-52|FAS for Efficacy (Extension Phase)|||Percentage of Participants|||Number
2711639|NCT01161524|Secondary|Percent Change From Baseline in Seizure Frequency Per 28 Days Over the Perampanel Duration Exposure (Extension Phase)|The median percent change in total partial onset seizure frequency per 28 days during the Extension Phase relative to the Pre-perampanel Baseline from Week 1 of perampanel treatment through successive 13-week intervals (Weeks 1 to 13 for subjects with any data, Weeks 1 to 26 for subjects with exposure of more than 13 weeks, Weeks 1 to 39 for subjects with exposure of more than 26 weeks, and Week 1 to 52 for subjects with exposure of more than 52 weeks) are presented. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.|Week 1-13, Week 14-26, Week 27-39, and Week 40-52|The Full Analysis Set (FAS) for Efficacy: All participants who received study drug during the Extension Phase, had baseline seizure frequency data, and had at least one observation of valid seizure diary data during the Extension Phase.|||Percent change||Full Range|Median
2711640|NCT01161524|Secondary|Number of Participants Who Achieved Seizure-Free Status During the Maintenance Period and the Last 28 Days of the Maintenance Period During the Randomization Phase (Core Study)|Number of Participants who were seizure free, were assessed.|13 Week Maintenance Period|FAS for efficacy|||Participants|||Number
2711641|NCT01161524|Secondary|Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Duration of the Randomization Phase (Core Study)|Seizure frequency was based on overall number of seizures obtained by summing the 4 seizure types (all partial seizure types, that is, simple partial without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalization) collected via the patient diary over a particular time interval and re-scaled to 28 days window.|Baseline and Week 19 LOCF|FAS for efficacy|||Percent change||Full Range|Median
2711642|NCT01161524|Secondary|Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency (Core Study)|A responder was a participant who experienced a 50% or greater reduction in seizure frequency compared to the baseline of the Randomization Phase.|From Baseline up to Week 19 LOCF|FAS for Efficacy: All subjects who sign informed consent, were randomized, received treatment, and had at least one postdose seizure efficacy assessment in seizure record was included in this analysis set.|||Percentage of Participants|||Number
2711643|NCT01161524|Secondary|Change From Baseline at Week 19 in the Speed of Memory T-score in the Randomization Phase (Core Study)|The Speed of Memory domain (one of the 5 CDR System cognitive domains) was a measure, which reflects the time taken to accurately retrieve information from working and episodic memory. Z-scores were calculated for this domain using normative data from the CDR System database for the age range of the study population. Specifically, Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Speed of Memory were also multiplied by -1, so that for all domains, greater T-scores reflected superior cognitive function and a negative change from baseline reflects impairment compared to the baseline assessment. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10.|Baseline and Week 19|FAS for cognition (Core Study)|||T-score||Standard Error|Least Squares Mean
2711644|NCT01161524|Secondary|Change From Baseline at Week 19 in the Quality of Working Memory (Short Term) T-score in the Randomization Phase (Core Study)|The Quality of Working Memory domain (one of the 5 CDR System cognitive domains) was a measure of reflecting how well individuals can hold numeric and spatial information 'on line' in working memory. Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Greater T-scores reflected superior cognitive function. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment.|Baseline and Week 19|FAS for cognition (Core Study)|||T-score||Standard Error|Least Squares Mean
2711645|NCT01161524|Secondary|Change From Baseline at Week 19 in the Quality of Episodic Secondary Memory T-score in the Randomization Phase (Core Study)|The Quality of Episodic Secondary Memory domain was a measure of the capability of individuals to encode, store, and subsequently retrieve verbal and nonverbal information in episodic (or declarative) memory; what was meant by memory in everyday terminology. This measure was derived by summing the scores from the 4 tasks: immediate and delayed word recall, word recognition, and picture recognition. Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Greater T-scores reflected superior cognitive function. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline.|Baseline and Week 19|FAS for cognition (Core Study)|||T-score||Standard Error|Least Squares Mean
2711691|NCT01161225|Secondary|Attitude Toward Illness Scale|"This 13-item scale was designed to assess children's attitude toward their health condition. The scale includes questions such as how good or bad do you feel it is that you have ___? and, how often do you feel that your ___ is your fault? Respondents answer each question on a 5-point Likert-type scale (1-5). Total summed scores (range: 25-65) was constructed to reflect respondents' overall attitudes. Higher scores indicated positive attitudes."|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
2711646|NCT01161524|Secondary|Change From Baseline at Week 19 in the Continuity of Attention T-score in the Randomization Phase (Core Study)|The Continuity of Attention domain (one of the 5 CDR System cognitive domains) was a measure of sustained attention, comprised of the accuracy scores from 2 of the CDR System attention tasks: choice reaction time and digit vigilance. Z-scores were calculated for this domain using normative data from the CDR System database for the age range of the study population. Specifically, Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Greater T-scores reflected superior cognitive function and a negative change from baseline reflects impairment compared to baseline. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10.|Baseline and Week 19|FAS for cognition (Core Study)|||T-score||Standard Error|Least Squares Mean
2711647|NCT01161524|Secondary|Change From Baseline at Week 19 in the Power of Attention T-score in the Randomization Phase (Core Study)|The Power of Attention domain (one of the 5 CDR System cognitive domains) was a measure of focused attention and information processing, comprised of the 3 CDR System attention tasks: the simple reaction time, choice reaction time and digit vigilance tasks. Z-scores were calculated for each domain by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the standard deviation (SD) of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Power of Attention were also multiplied by -1, so that for all domains, greater T-scores reflected superior cognitive function. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. The CDR System Global Cognition score was created by adding the T-scores for the five domains. A decrease in the score of Power of Attention indicated improvement in cognitive function and a negative change reflects impairment from baseline.|Baseline and Week 19|FAS for cognition (Core Study)|||T-score||Standard Error|Least Squares Mean
2711648|NCT01161524|Primary|Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study)|The CDR System Global Cognitive score was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). The domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 - 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function.|Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward)|Full Analysis Set (FAS) for Cognition: All randomized subjects who received study drug, had baseline cognition data, and had at least one postdose CDR System cognitive battery test assessments at or after Week 10.|||Scores on a scale||Standard Deviation|Mean
2711649|NCT01161498|Secondary|Participants With N1-2 Disease at Baseline Requiring Neck Dissection|Participants with Baseline Nl or N2 disease (lymph node metastasis not more than 6 cm in greatest dimension) with persistent disease as determined at the post chemoradiotherapy assessment of response were to proceed to neck dissection as permitted by the institution no later than Week 22. Since this study terminated prematurely neck dissection data were not collected or analyzed.|Weeks 19 - 21|||||||
2711650|NCT01161498|Secondary|Disease-specific Survival|"Disease-specific survival is defined as the time from randomization to death of the patient due to the cancer under study.~Because this study was terminated with 5 participants enrolled, disease-specific survival was not analyzed."|Up to 5 years after chemoradiotherapy|||||||
2711651|NCT01161498|Secondary|Overall Survival|"Overall survival is defined as the time from randomization to death from any cause.~Because this study was terminated with 5 participants enrolled, overall survival was not analyzed."|Up to 5 years after chemoradiotherapy|||||||
2711652|NCT01161498|Secondary|Time to Any Failure|"Any failure is defined as disease progression at any site at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 participants enrolled, time to any failure was not analyzed."|Up to 27 months|||||||
2711653|NCT01161498|Secondary|Time to Distant Failure|"Distant failure is defined as disease progression at any site other than the head and neck area at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 participants enrolled, time to distant failure was not analyzed."|Up to 27 months|||||||
2711654|NCT01161498|Secondary|Time to Locoregional Failure|"Locoregional failure is defined as disease progression in the head and neck area at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 subjects enrolled, time to locoregional failure was not analyzed."|Up to 27 months|||||||
2711655|NCT01161498|Secondary|Pathologic Complete Response (mCR)|"Response to therapy was assessed histopathologically from biopsies taken at surgery for those participants who had surgery prior to Week 22.~If no viable tumor cells were identified in surgical specimens (where the patient had surgery) the patient was classified as having a pathological complete response (pCR), and if viable tumor cells were identified, the patient was classified as having an incomplete pathologic response.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the pathologic complete response rate was not calculated. Therefore a summary of participants with a pathologic complete response before the end of study is reported."|Up to Week 20|Randomized participants who had protocol-specified surgery|||participants|||Number
2711656|NCT01161498|Secondary|Metabolic Complete Response (mCR)|"Response to therapy was assessed using [(18)F] fluorodeoxyglucose positron emission tomography (FDG PET) imaging to detect metabolically active tumors.~Metabolic complete response (mCR) is defined as complete disappearance of FDG uptake attributable to tumor compared to baseline scan.~Partial metabolic response (mPR) is defined as a > 40% decrease in specific uptake compared to the initial value in over half of the lesions.~Disease progression (mPD) is defined as a specific uptake increase in any lesion, appearance of new lesions, or presence of extended areas of disease activity.~Stable metabolic response (mSD) is defined as a decrease in uptake < 40% of the initial value of over half the lesions.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the metabolic complete response rate was not calculated. Therefore a summary of metabolic response at end of study is reported."|End of study; the maximum time on study was 20 weeks.|All randomized participants|||participants|||Number
2711739|NCT01160822|Secondary|Maximum Observed Plasma Concentration of Canakinumab (Cmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||µg/mL||Standard Deviation|Mean
2711657|NCT01161498|Secondary|Clinical Objective Response (cOR)|"Tumor response was assessed by computed tomography (CT) scan according to a modified version of the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1). Objective response is defined as achieving a clinical partial response (cPR) or complete response (cCR). cCR is defined as disappearance of all baseline lesions. Any pathological lymph nodes must have a reduction in short axis to < 10 mm. cPR is defined as at least a 30% decrease in the sum of diameters of baseline lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of baseline lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of any new lesions.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the cOR rate was not calculated. Therefore a summary of response at the end of study is reported."|End of trial; the maximum time on study was 20 weeks.|All randomized participants|||participants|||Number
2711658|NCT01161498|Primary|2-year Event-free Survival|Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.|2 years|||||||
2711659|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT) on Day 6|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Words Recalled||Standard Error|Least Squares Mean
2711660|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT)|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Words Recalled||Standard Deviation|Mean
2711661|NCT01161472|Secondary|Change From Baseline in CogState Groton Maze Learning Task on Day 6|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Error|Least Squares Mean
2711662|NCT01161472|Secondary|CogState Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Deviation|Mean
2711663|NCT01161472|Secondary|Change From Baseline in CogState CPAL on Day 6|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Error|Least Squares Mean
2711664|NCT01161472|Secondary|CogState Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Deviation|Mean
2711740|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 12|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711665|NCT01161472|Secondary|Change From Baseline in CogState One Card Learning on Day 6|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Arcsine [(sqrt) proportion correct]||Standard Error|Least Squares Mean
2711666|NCT01161472|Secondary|CogState One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Arcsine [(sqrt) proportion correct]||Standard Deviation|Mean
2711667|NCT01161472|Secondary|Change From Baseline in CogState Identification Speed on Day 6|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Error|Least Squares Mean
2711668|NCT01161472|Secondary|CogState Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Deviation|Mean
2711669|NCT01161472|Primary|Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Error|Least Squares Mean
2711670|NCT01161472|Primary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline|The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Deviation|Mean
2711671|NCT01161446|Secondary|Number of Male Condomless Anal Intercourse Partners in Last 3 Months||From 6 to 9 and 12 to 15 months|"Included Overall Number of Participants Analyzed as number who completed follow-up. However, only participants who responded to the question regarding condomless anal intercourse partners in the last 3 months were included in this analysis for each time point."|||number of partners||Standard Error|Mean
2711672|NCT01161446|Secondary|Bacterial Sexually Transmitted Infections|Includes syphilis, gonorrhea, and chlamydial infection|Assessed at 15 months|Includes only participants who received screening for sexually transmitted infections at the end-of-study visit.|||Participants|||Count of Participants
2711673|NCT01161446|Secondary|Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months||From 6 to 9 months and 12 to 15 months of follow-up|"Included Overall Number of Participants Analyzed as number who completed follow-up. However, only participants who responded to the question regarding non-concordant condomless anal intercourse in the last 3 months were included in this analysis for each time point."|||Participants|||Count of Participants
2711674|NCT01161446|Primary|HIV Testing Frequency|Number of HIV tests during follow-up reported by participants at end-of-study visit|15 months||||HIV tests||95% Confidence Interval|Mean
2711675|NCT01161420|Secondary|Percentage Sleep Time at SaO2 < 90%|"The percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations.~The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months."|12 months||||Percentage of Sleep Time SaO2 <90%||95% Confidence Interval|Mean
2711741|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 8|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711677|NCT01161420|Secondary|Change in FOSQ From Baseline to 12 Months|The Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
2711678|NCT01161420|Secondary|Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects|"The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit.~The following subjects were included:~All implanted subjects who had AHI data collected at both baseline and 12-months follow-up.~All implanted subjects who had baseline data but no 12-month data, and had their last data values carried forward, provide they had a least 6-month AHI data.~Any implanted subject who did not have 12-month data available due to therapy failure (e.g., study withdrawal will be included in the analsys as a treatment failure."|12 months|Implanted subjects|||Number of subjects responding to therapy|||Number
2711679|NCT01161420|Secondary|AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study|The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep.|12 Months|The first 46 responders to the Inspire therapy at 12 months were randomized 1:1 to either the Therapy Maintenance Group (ON) or the Therapy Withdrawal Group (OFF). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups.|||events per hour||95% Confidence Interval|Mean
2711680|NCT01161420|Primary|Safety|The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.|12 months||||Events Reported|||Number
2711681|NCT01161420|Primary|Oxygen Desaturation Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.|12 months||||percentage of subjects responding|||Number
2711682|NCT01161420|Primary|Apnea Hypopnea Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.|12 months||||percentage of subjects responding|||Number
2711683|NCT01161407|Secondary|"Bone Balance From Calcium Kinetics"|Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling.|2 weeks||||mg/d calcium||Standard Error|Least Squares Mean
2711684|NCT01161407|Secondary|Phosphorus Balance|Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces.|2 weeks||||mg/d phosphorus||Standard Error|Least Squares Mean
2711685|NCT01161407|Primary|Calcium Balance|Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).|2 weeks||||mg/d calcium||Standard Error|Least Squares Mean
2711686|NCT01161329|Primary|Short Physical Performance Battery (SPPB)|Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.|Baseline, after 3, 6 months and after 1 year||||units on a scale||Standard Deviation|Mean
2711687|NCT01161329|Primary|The Berg Balance Scale (BBS)|Total score on the scale: 0-56 Points. Higher scores indicates better balance.|baseline, after 3, 6 months and after 1 year||||units on a scale||Standard Deviation|Mean
2711688|NCT01161225|Secondary|Health Care Utilization Events|Participants report the following information for the prior 3-month period; their emergency department visits for asthma; hospitalization for asthma; urgent office visit for worsening asthma; routine office visit; specialist visit. A cumulative number of events were computed by adding # of visits and # of days (for hospitalization) occurred in the past 3 months .|9-months postcamp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||average number of events||Standard Deviation|Mean
2711689|NCT01161225|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|Maximal amount of air one can forcefully exhale in one second. It is then converted to a percentage of normal. Range: 55-124 for the current sample.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed spirometry at 9-months assessment.|||percentage of predicted FEV1||Standard Deviation|Mean
2711690|NCT01161225|Secondary|Asthma Knowledge Questionnaire|This 30-item instrument was developed to measure children's knowledge on triggers and symptom identifications, and asthma management procedures (i.e., what to do and how to do it) in a true/false format. Total scores (range: 14-30) were computed by summing the number of items correctly answered. The higher scores indicate greater knowledge levels.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
2711742|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711692|NCT01161225|Secondary|Illness Management Survey|This 29-item scale was developed to assess perception of barriers and to predict risk for poor self-management in adolescents with chronic illness. This scale categorizes barriers based on internal processes (e.g., cognitive skills, denial, pessimistic thinking) and contextual forces (e.g., illness-related factors, peer/family influences). Total summed scores were computed (range: 28-91). Higher scores indicate the high levels of perceived barriers to self-management.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
2711693|NCT01161225|Secondary|Asthma Self-Efficacy|This 14-item scale was developed to measure the child's confidence in attack prevention (e.g., learn asthma self-management skills, correct use of medication) and attack management (e.g., control symptoms, decide which medication to use). Total summed scores were computed (range: 21-70). Higher total scores indicate greater degree of self-efficacy.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
2711694|NCT01161225|Primary|Asthma Control Questions|This measure assesses the frequencies of the limitation of daily activity, asthma symptoms (daytime and nighttime) and use of rescue medication in the past 4 weeks on a 5-point scale (0-4). Total summed scores were computed (range: 4-16). Higher total scores indicate better controlled asthma.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
2711695|NCT01161225|Primary|Pediatric Asthma Quality of Life Questionnaire (PAQLQ)|Twenty-three items cover problems identified as being most important and troublesome in children's everyday lives due to asthma. This scale is effective in evaluating and discriminating because of its high sensitivity to changes in asthma status within and between individuals with varying severity of asthma. Respondents are asked to recall impairments experienced during the previous week. The scale consists of three subdomains including symptoms (10 items), emotional function (8 items) and activity limitation (5 items). Each item was measured on a 7-point scale; 1 indicates maximum impairment, and 7 indicates no impairment. Higher total scores indicate better levels of functioning. Total scores were computed by summing responses from all items (range:24-161)|9 months post camp|The number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
2711696|NCT01161173|Secondary|Percentage of Participants Who Developed Rash|At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.|||Percentage of participants||95% Confidence Interval|Number
2711697|NCT01161173|Secondary|Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores|Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with LCSS scores were included in the analysis.|||Units on a scale||95% Confidence Interval|Mean
2711698|NCT01161173|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until or death from any cause|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.|||Months||95% Confidence Interval|Median
2711699|NCT01161173|Secondary|Progression-free Survival|Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Months||95% Confidence Interval|Median
2711700|NCT01161173|Secondary|Time to Disease Progression|The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Months||95% Confidence Interval|Median
2711743|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 2|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711744|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Day 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711701|NCT01161173|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|"The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was confirmed if a subsequent RECIST evaluation also showed a CR or PR."|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2711702|NCT01161160|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711703|NCT01161160|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 21 days after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711704|NCT01161160|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711705|NCT01161160|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711706|NCT01161160|Secondary|Number of Subjects With pIMDs|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711707|NCT01161160|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711708|NCT01161160|Secondary|Number of Subjects With MAEs|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711709|NCT01161160|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|Up to day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711710|NCT01161160|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 6 to 10 years who received the study vaccine.|||Participants|||Count of Participants
2711711|NCT01161160|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C or > 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 3 to 5 years who received the study vaccine.|||Participants|||Count of Participants
2711712|NCT01161160|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to < 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2711713|NCT01161160|Secondary|HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2711714|NCT01161160|Secondary|Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value|The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Participants|||Count of Participants
2711715|NCT01161160|Secondary|HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain|Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2711716|NCT01161160|Secondary|Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value|The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2711717|NCT01161160|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was > 2.5.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2711718|NCT01161160|Secondary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Participants|||Count of Participants
2711719|NCT01161160|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was > 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was > 40%.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Participants|||Count of Participants
2711720|NCT01161160|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was > 2.5.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2711721|NCT01161160|Primary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjeects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2711722|NCT01161160|Primary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2711723|NCT01161160|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2711724|NCT01161121|Secondary|Side Effects of Medication Administration|Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath|During drug infusion and until restoration of baseline hemodynamics||||participants|||Number
2711725|NCT01161121|Secondary|Heart Rate Changes With Drug|Maximal heart rate documented following the administration of each agent|During drug infusion and until restoration of baseline hemodynamics||||beats per minute||Standard Deviation|Mean
2711726|NCT01161121|Primary|Difference in FFR Between IV Adenosine and IV Regadenoson|FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson|At maximal, steady-state hyperemia|Per protocol|||ratio (Pd/Pa)||Standard Deviation|Mean
2711727|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|24 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
2711728|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|12 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
2711729|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|8 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
2711730|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|3 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
2711731|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|3 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
2711732|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|1.5 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
2711733|NCT01160822|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.|||mL||Standard Deviation|Mean
2711734|NCT01160822|Secondary|Apparent Clearance of Canakinumab From Plasma (CL/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.|||mL/hr||Standard Deviation|Mean
2711735|NCT01160822|Secondary|Terminal Phase Half-life (t1/2) of Canakinumab|The time it takes for the concentration level of canakinumab to fall to 50% of the original value.|Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||hours||Standard Deviation|Mean
2711736|NCT01160822|Secondary|Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||µg*day/mL||Standard Deviation|Mean
2711737|NCT01160822|Secondary|Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||µg*day/mL||Standard Deviation|Mean
2711738|NCT01160822|Secondary|Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||hours||Full Range|Median
2711748|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 2|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711749|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment on Day 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
2711750|NCT01160822|Secondary|Part B: Proportion of Participants Who Used Rescue Analgesic During Study|Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.|Day 4, Weeks 1, 2, 4, 8 and 12|Safety analysis set (all participants as assigned that received at least one dose of study drug).|||proportion of participants|||Number
2711751|NCT01160822|Secondary|Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales|"The WOMAC consists of 3 subscales:~The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.~The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.~The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.~Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.|||units on a scale||Standard Deviation|Mean
2711752|NCT01160822|Secondary|Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)|A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).|Baseline, Day 4, Weeks 1, 2, 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2711753|NCT01160822|Secondary|Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).~Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.|||units on a scale||Standard Deviation|Mean
2711754|NCT01160822|Primary|Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale|"The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.~Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Week 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.|||units on a scale||Standard Deviation|Mean
2711755|NCT01160822|Primary|Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.~Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects."|Baseline and Day 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.|||units on a scale||Standard Deviation|Mean
2711756|NCT01160822|Primary|Part A: Number of Participants With Intolerance Events|An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.|Baseline to Day 3|Safety analysis set.|||participants|||Number
2711757|NCT01160770|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms|"The parent/caregiver was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36||||percentage of participants|||Number
2711758|NCT01160770|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms|"The physician was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36||||percentage of participants|||Number
2711763|NCT01160744|Other Pre-specified|Change in Tumor Size (CTS)|CTS was defined as the log ratio of tumor size at 6 weeks to tumor size at baseline. CTS at 6 weeks=Log (Sum of Target Lesion Measurements at 6 Weeks)-Log (Sum of Target Lesion Measurements at Baseline).|Baseline, 6 weeks|All randomized participants with results at baseline and 6 weeks.|||log ratio||Standard Deviation|Mean
2711764|NCT01160744|Other Pre-specified|Percentage of Participants With CR, PR, or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.|||percentage of participants||90% Confidence Interval|Number
2711765|NCT01160744|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died|Data presented are the number of participants with at least 1 treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (SAE), as well as, the number of participants who died during the study. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). A summary of SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Day 1, Cycle 1 (3-week cycles) Up to 3 Years|All randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2711766|NCT01160744|Secondary|Duration of Response (DOR)|DOR was measured from the time criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death. Response was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker level of non-target lesions. PR was defined as ≥30% decrease SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Time of first response (CR or PR) until PD or death (up to 24 months)|All randomized participants with a best overall response of CR or PR. Participants censored: Pem+Carb/Cis=44, Ram+Pem+Carb/Cis=35, Gem+Carb/Cis=50, Ram+Gem+Carb/Cis=37.|||months||90% Confidence Interval|Median
2711767|NCT01160744|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause (up to 31.3 months)|ITT Population: All randomized participants. Participants censored: Pem+Carb/Cis=22, Ram+Pem+Carb/Cis=16, Gem+Carb/Cis=32, Ram+Gem+Carb/Cis=32. Censored participants were included in the analysis.|||months||90% Confidence Interval|Median
2711768|NCT01160744|Secondary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.|||percentage of participants|||Number
2711769|NCT01160744|Primary|Progression-Free Survival (PFS)|PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (mm); appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants alive and without disease progression were censored at the time of the last objective tumor assessment. Participants who did not progress and were lost to follow-up were censored at their last radiographic assessment. If no baseline or post baseline radiologic assessments were available, participants were censored at date of randomization.|Randomization to PD or death (up to 24 months)|Intent-to-Treat (ITT) Population: All randomized participants. Participants censored: Pem+Carb/Cis=14, Ram+Pem+Carb/Cis=13, Gem+Carb/Cis=14, Ram+Gem+Carb/Cis=18.|||months||90% Confidence Interval|Median
2711770|NCT01160640|Secondary|Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.|Identification of endometrial microorganisms present obtained from women with or without evidence of endometritis using a combination of culture methods, rRna sequencing and whole genomic sequencing. The aim is to identify the etiology of endometritis.|enrollment|Women who had an endometrial sample that was sufficient for histologic assessment for endometritis.|||participants|||Number
2711771|NCT01160640|Secondary|Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis|Clinical response to treatment is improvement (reduction) of the McCormack Scale total score from baseline to day 3 follow-up visit. Participants without a 3-day measure were considered treatment failures.|Enrollment to 3 day follow up visit||||participants|||Number
2711772|NCT01160640|Secondary|The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.|M. genitalium not detected in the cervical and endometrial cultures by nucleic acid amplification testing at the 30 day visit among women who had M. genitalium detected at either anatomical site at the enrollment visit.|Enrollment to 30 days|There were 34 women who had M. genitalium detected in the cervix or endometrium at enrollment who had test results from the 30-day visit.|||participants|||Number
2711773|NCT01160640|Secondary|The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.|The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.|enrollment||||participants|||Number
2711774|NCT01160640|Primary|Clearance of Anaerobic Organisms From the Endometrium|Clearance of anaerobic microorganisms from the endometrium at the 30 day follow-up visit among women who had anaerobic microorganisms detected in their endometrial tissue sample at enrollment. Clearance is defined as no anaerobic microorganisms detected in the endometrial tissue biopsy sample collected at the 30-day visit.|Enrollment to 30 days|Women who had anaerobic microorganisms detected in their endometrial biopsy sample at enrollment based on standard bacterial culture techniques.|||participants|||Number
2711775|NCT01160614|Primary|The Number of Patients With Adverse Events as a Measure of Safety||Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).|The safety population (N = 30) was defined as the group of patients who received study drug|||participants|||Number
2711776|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Lag Time Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value From Hour 0 to 12 Hours of the First Dose of ORF (Tlag 0-12)|Due to insufficient sampling, tlag 0-12 was not estimated.|Up to 12 hours|||||||
2711777|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||h||Full Range|Median
2711778|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng/mL||Standard Deviation|Mean
2711779|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng*h/mL||Standard Deviation|Mean
2711780|NCT01160614|Primary|Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)|Due to insufficient sampling, tlag was not estimated.|Up to 24 hours|||||||
2711781|NCT01160614|Primary|Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)|Due to insufficient sampling, t1/2z was not estimated.|Up to 24 hours|||||||
2711782|NCT01160614|Primary|Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)|Due to insufficient sampling, Lamda z was not estimated.|Up to 24 hours|||||||
2711783|NCT01160614|Primary|Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||hour (h)||Full Range|Median
2711784|NCT01160614|Primary|Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng/mL||Standard Deviation|Mean
2711785|NCT01160614|Secondary|Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)||Up to 72 hours if all 5 doses were administered|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng/mL||Standard Deviation|Mean
2711786|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)|Due to insufficient sampling, AUCinf was not estimated.|Up to 24 hours|||||||
2711787|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng*h/mL||Standard Deviation|Mean
2711788|NCT01160484|Secondary|Follow-up Time|time that patients were monitored for disease progression and overall survival|Follow-up visits for disease progression and overall survival every 3 months after study discontinuation. After progression, follow-up visits for survival status every 6 months or until alternate therapy needs to be started or death intervenes||||months||Full Range|Median
2711789|NCT01160484|Secondary|Progression-free Survival||Time from the start of treatment to progressive disease or until death||||months||Full Range|Median
2711790|NCT01160484|Secondary|Time to Progression||Time from the start of treatment to progressive disease||||months||Full Range|Median
2711791|NCT01160484|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.||||months||Full Range|Median
2711792|NCT01160484|Secondary|Time to Best Response||Up to 7.5 months (eight 28-day cycles)||||months||Full Range|Median
2711793|NCT01160484|Secondary|Time to First Response||Up to 7.5 months (eight 28-day cycles)||||months||Full Range|Median
2711893|NCT01159171|Secondary|Overall Survival (OS) - Percentage of Participants With an Event by 24 Months|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||percentage of participants|||Number
2711794|NCT01160484|Primary|International Myeloma Working Group (IMWG) Response Criteria|The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.|Up to 7.5 months (eight 28-day cycles)|Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria [complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)]|||participants|||Number
2711795|NCT01160458|Secondary|Overall Survival (OS)|Overall survival is the time interval from the start of treatment to the date of death.|To study completion, an average of 3 years|One participant withdrew from the study and was excluded from the analysis.|||Months||95% Confidence Interval|Median
2711796|NCT01160458|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|To study completion, an average of 3 years|One participant withdrew from the study and was excluded from the analysis.|||months||95% Confidence Interval|Median
2711797|NCT01160458|Secondary|Duration of Overall Response|Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|36 months|No participants had a complete response or partial response.||||||
2711798|NCT01160458|Secondary|Safety of IMC-A12 in Patients With Mesothelioma|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 36 months||||Participants|||Count of Participants
2711799|NCT01160458|Primary|Clinical Response Rate (PR+CR)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|36 months||||Participants|||Count of Participants
2711800|NCT01160445|Secondary|Toxicity of Zanolimumab and IL-2 Treatment Regimen|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10 months||||Participants|||Number
2711801|NCT01160445|Primary|The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.|Tumor regression was assessed by the Response Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% in the sum of the longest diameter (LD) recorded since the treatment started. Stable disease (SD) is neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|2 years||||Participants|||Number
2711802|NCT01160380|Secondary|Epworth Sleepiness Scale (ESS) Score|Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness|Day 1, Day 28 and Day 56||||units on a scale||Standard Deviation|Mean
2711803|NCT01160380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.|Day 1, Day 28 and Day 56||||units on a scale||Standard Error|Mean
2711804|NCT01160380|Secondary|Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score|Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).|Day 1, Day 28 and Day 56||||units on a scale||Standard Deviation|Mean
2711805|NCT01160380|Primary|Digit Span Test Score|Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.|Day 1, Day 28 and Day 56||||Number of correct items||Standard Deviation|Mean
2711806|NCT01160380|Primary|Symbol Digit Modalities Test Score (SDMT)|Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance|Day 1, Day 28 and Day 56||||Number of correct matches||Standard Deviation|Mean
2711807|NCT01160380|Primary|Trail Making Test B Score (TMT-B)|"Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.~The test evaluates the time to correctly order letters and numbers; low times = better performance."|Day 1, Day 28 and Day 56||||seconds||Standard Deviation|Mean
2711809|NCT01160354|Secondary|Number of Participants With Overall Response During Second Part of Study|Overall response (OR) = Complete Remission (CR) + Partial Remission (PR) where response defined: Complete remission (CR): Disappearance all clinical +/or radiologic evidence disease. Neutrophil count >/=1.0x109/L & platelet count >/=100x10^9/L, & normal bone marrow differential (</= 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but with platelet counts of <100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but both decrease in marrow blasts >50% & not more than 6 to 25% abnormal cells in the marrow. Treatment Failure: For purposes of efficacy analysis of remission, less than a CR, CRi, or PR categorized as Treatment Failure.|Continuously monitored, assessments at 12 weeks|Study halted early without continuing to second part (Phase II). This outcome measure is to analyze the overall response during the Phase II portion of this study. The study was halted early and did not enroll any patients in the phase II portion. Therefore, there are Zero patients to analyze and no data to report.||||||
2711810|NCT01160354|Secondary|Participants' Response During First Part of Study|Response defined as Complete remission (CR): Disappearance all clinical +/or radiologic evidence disease. Neutrophil count >/=1.0x10^9/L & platelet count >/=100x10^9/L, & normal bone marrow differential (</= 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but with platelet counts of <100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but both decrease in marrow blasts >50% & not more than 6 to 25% abnormal cells in the marrow.|Assessments following 3 cycles (at 12 weeks) up to 5 cycles (20 weeks)|Two participants were not evaluable due to unrelated early death.|||Participants|||Count of Participants
2711811|NCT01160354|Primary|Number of Participants in Phase I With First Cycle Dose Limiting Toxicities (DLT) Observed|Dose limiting toxicity (DLT) consists of participants who developed DLT during maximum tolerated dose (MTD) estimation period where DLTs observed during dose escalation were used to develop MTD. The MTD is the highest dose level in which <2 participants of 6 develop first cycle. DLT. Toxicity graded according to the NCI Common Toxicity Criteria Version 3.0. The timeframe to assess dose-limiting toxicities (DLT's) will be the first cycle of treatment, i.e. the first 4 weeks on study. The Plerixafor dose to be used in Phase II of the protocol is the highest dose at which no more than 1 of 6 patients experience a DLT in the Phase I part of the protocol or a lower dose selected at the end of dose escalation.|First cycle of treatment, i.e. first 4 weeks on study|Intent to treat population included all registered participants.|||Participants|||Count of Participants
2711812|NCT01160289|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Insulin|Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting insulin) at baseline and at a post-baseline visit.|||milliunits per Liter (mU/L)||Standard Error|Least Squares Mean
2711813|NCT01160289|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Glucose|The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting glucose) at baseline and at a post-baseline visit.|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
2711814|NCT01160289|Secondary|Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)|The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (HDL-C and LDL-C) at baseline and at a post-baseline visit.|||percent change||Standard Error|Least Squares Mean
2711815|NCT01160289|Secondary|Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides|The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (total cholesterol and triglycerides) at baseline and at a post-baseline visit.|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
2711816|NCT01160289|Secondary|Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)|The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing PSA data at baseline and at a post-baseline visit.|||nanograms per milliliter (ng/mL)||Standard Error|Least Squares Mean
2711817|NCT01160289|Secondary|Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups|The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF EF domain scores at baseline and at a post-baseline visit; Last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2711842|NCT01159938|Secondary|Change in Postprandial Pulse Wave Velocity (PWV)|The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and post-baseline PWV measurement at specified time point and no major protocol deviation.|||meters per second (m/sec)||Standard Deviation|Mean
2711818|NCT01160289|Secondary|"Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to Normal on the International Index of Erectile Function (IIEF) Scale (EF>25)"|The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
2711819|NCT01160289|Secondary|Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)|Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF domain scores at baseline and at a post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2711820|NCT01160289|Secondary|"Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary"|"The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of Yes responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of Yes responses indicated better EF. Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25)."|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing SEP diary data at baseline and at a post-baseline visit.|||"percentage of yes responses"||Standard Error|Least Squares Mean
2711821|NCT01160289|Primary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score|The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.|Baseline, Week 12|Randomized participants who received at least 1 dose of study drug [intention-to-treat (ITT) population] and had non-missing IIEF EF domain scores at baseline and at Week 12; Last observation carried forward (LOCF) applied to statistical analyses.|||units on a scale||Standard Deviation|Mean
2711822|NCT01160237|Secondary|Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years||At Days 0, 7 and 182|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2711823|NCT01160237|Secondary|Potential Immune Mediated Diseases||During the whole study period (Day 0 - Day 182)|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2711824|NCT01160237|Secondary|Number of Subjects Reporting Serious Adverse Events||During the whole study period (Day 0 - Day 182)|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.|||subjects|||Number
2711825|NCT01160237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||During 31 days (Day 0 - Day 30) after vaccination|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.|||subjects|||Number
2711826|NCT01160237|Secondary|Solicited Local and General Symptoms||During 7 days (Day 0 - Day 6) after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2711827|NCT01160237|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years||21 days after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
2711828|NCT01160211|Secondary|Time to Response in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI|Time to response in lapatinib+trastuzumab+AI vs. trastuzumab+AI and lapatinib+AI vs. trastuzumab+AI. Time to response is defined as time from randomization to first documented Complete Response or Partial Response.|approximately 5 years|ITT|||Days||Full Range|Median
2711829|NCT01160211|Primary|Median Kaplan Meier Estimates for PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination|Progression free survival (PFS) of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination. PFS is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor.|approximately 5 years|ITT population|||Months||95% Confidence Interval|Median
2711843|NCT01159938|Secondary|Change in Blood Glucose (BG)|Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline blood glucose measurement at specified time point and no major protocol deviation.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2711990|NCT01158222|Primary|Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it|Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.|after 6 months of treatment (4 cycles)||||Participants|||Count of Participants
2711830|NCT01160211|Secondary|Changes in the Quality of Life (QoL) Status Relative to Baseline FACT-B Overall and Subscale Scores at Last On-treatment Assessment|"Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. It is a 37-item (27 general questions and 10 breast cancer specific questions) self-reporting instrument consisting of 5 dimensions: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The followings are the score ranges for each self-reporting subscale: • PWB : 0-28 • SWB : 0-28 • EWB : 0-24 • FWB : 0-28 • BCS : 0-40 FACT-B Total Outcome Index (TOI) = PWB + FWB + BCS (range:0 - 96) FACT-B Total Score = PWB + SWB + EWB + FWB + BCS (range:0-148) FACT-G Total Score = PWB + SWB + EWB + FWB (range:0-108) In the scoring system, negative stated items are reversed by subtracting the response from 4 and after reversing proper items, all subscale items are summed to a total, which is the subscale score. For all the FACIT scales and symptom indices, the higher the score the better cut off"|approximately 5 years|ITT|||score on a scale||Standard Error|Least Squares Mean
2711831|NCT01160211|Secondary|Duration of Response in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI|Kaplan-Meier estimates for duration of response in lapatinib+trastuzumab+AI vs. trastuzumab+AI and lapatinib+AI vs. trastuzumab+AI. Duration of response is defined as the time from first documented Complete Response or Partial Response until the first documented sign of Progressive Disease or Death, or to the date of censor.|approximately 5 years|ITT|||Months||95% Confidence Interval|Median
2711832|NCT01160211|Secondary|Clinical Benefit Rate (CBR; Complete Response, Partial Response, or Stable Disease for at Least 6 Months) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI|Clinical Benefit Rate (CBR) was defined as the percentage of patients with evidence of complete response (CR) or partial response (PR) at any time or maintaining SD for at least 24 weeks while on study, according to the investigator assessment of response per RECIST 1.1 criteria.|approximately 5 years|ITT|||Participants|||Count of Participants
2711833|NCT01160211|Secondary|Overall Response Rate (ORR; Complete or Partial Response) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI|The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence & was determined programmatically using investigators assessment of responses of target lesion, non-target lesion and new lesions based on RECIST v1.1. CR=disappearance of all target lesion & non-target lesions, if applicable, and no new lesion; PR = ≥30% decrease in the sum of the longest diameter of target lesions & non-target lesion was neither non-CR nor progressive disease (Non-PD) or not evaluable (NE); stable disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD should maintain for at least 56 days); PD = ≥20% increase from nadir (smallest sum diameters recorded since treatment start) of the target lesions and/or any status for non-target lesions or appearance of new lesion; NE = cannot be classified by the above definitions. Overall Response (OR) = CR + PR.|approximately 5 years|ITT|||Participants|||Count of Participants
2711834|NCT01160211|Secondary|Overall Survival (OS) Events of Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI|OS was defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For subjects who did not die during the study, death was censored at the date of last contact.|approximately 5 years|ITT|||Participants|||Count of Participants
2711835|NCT01160211|Secondary|PFS of Trastuzumab/AI vs. Lapatinib/AI and Trastuzumab/Lapatinib/AI vs. Lapatinib/AI|PFS in the lapatinib arm vs. the trastuzumab arm and in the lapatinib+trastuzumab arm vs. the lapatinib arm.|approximately 5 years|ITT Population|||Participants|||Count of Participants
2711836|NCT01160211|Primary|PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination|Progression free survival (PFS) of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination. PFS is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor.|approximately 5 years|ITT population|||Participants|||Count of Participants
2711837|NCT01160198|Secondary|Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate|The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence.|Up to Week 8|Intent to treat (ITT) population which comprised of all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2711838|NCT01160198|Secondary|Mean Change in Hb During 8 Weeks Therapy|At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented.|Up to Week 8|PP population. Only those participants available at the specified time points were analyzed.|||gm/dL||95% Confidence Interval|Mean
2711839|NCT01160198|Secondary|Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment|At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented.|Up to Week 8|PP population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2711840|NCT01160198|Secondary|Mean Change in Hb From Baseline to 8 Weeks|At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline to Week 8|PP population. Only those participants with data available at the indicated time points were analyzed.|||gm/dL||95% Confidence Interval|Mean
2711841|NCT01160198|Primary|Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)|At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline and Week 8|Per protocol (PP) population.|||Gram per deciliter (gm/dL)||95% Confidence Interval|Mean
2711891|NCT01159262|Primary|Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion||During study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.|||percentage of subjects|||Number
2711844|NCT01159938|Secondary|Change in QT Interval on Electrocardiogram (ECG)|QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline QT interval measurement at specified time point and no major protocol deviation.|||milliseconds (msec)||Standard Deviation|Mean
2711845|NCT01159938|Secondary|Change in Peripheral Artery Tonometry (PAT)|The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)|Enrolled healthy and randomized T2DM participants who had a baseline and a post-baseline PAT measurement at specified time point and no major protocol deviation.|||percentage of pulse amplitude||Standard Deviation|Mean
2711846|NCT01159938|Secondary|Change in Pulse Wave Amplitude (PWA)|The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants with a baseline and a post-baseline PWA measurement at specified time point and no major protocol deviation.|||percentage of systolic peak||Standard Deviation|Mean
2711847|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|240 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
2711848|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|180 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
2711849|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|120 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
2711850|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|60 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
2711851|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|30 mins (pre-breakfast)|Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/s)||95% Confidence Interval|Least Squares Mean
2711852|NCT01159912|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the ages of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates total impairment and a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
2711892|NCT01159171|Secondary|Overall Survival|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||months||Standard Deviation|Mean
2711853|NCT01159912|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2711854|NCT01159912|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2711855|NCT01159912|Secondary|Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough evening PEF is the PM PEF measured approximately 24 hours after the last evening administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2711856|NCT01159912|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2711857|NCT01159912|Primary|Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
2711858|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied were you with olopatadine 0.2%? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 7|All subjects who used the study medication at least once (intent to treat).|||Percentage of Participants|||Number
2711859|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 0|All subjects who used the study medication at least once (intent to treat).|||Percentage of Participants|||Number
2711958|NCT01158703|Secondary|Number of Major Adverse Cardiovascular Events With Combination Therapy|Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of all events reported|||MACE Events over 52Wks|Participants||Number
2711860|NCT01159743|Secondary|Change Over Time in Body Fat Distribution|"Change over time in total body fat and fat in the limbs and trunk was assessed by dual X-ray absorptiometry (DEXA) in participants for whom a DEXA measurement performed at least 6 months before participation in this study was available.~A negative change score indicates fat loss over time and a positive change score indicates fat gain over time."|DEXA performed at the study visit and more than 6 months prior to the study visit (the period of time between the DEXA recorded at the study visit and the previous DEXA ranged from 6 to 36 months).|Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available.|||kg||Standard Deviation|Mean
2711861|NCT01159743|Secondary|Lipodystrophy Severity Grading Scale (LSGS) Scores|"Perception of body fat was assessed by the Lipodystrophy Severity Grading Scale (LSGS), a standardized measurement of subjective lipoatrophy (fat loss) and lipoaccumulation (fat gain) perceived by the participant and by the physician. The degree of lipoatrophy and diffuse fat accumulation at each region was rated by both the participant and the physician as: Score 0=absent; Score 1=mild or noticeable on close inspection; Score 2=moderate or readily noticeable by patient/physician; Score 3=severe or readily noticeable to a casual observer.~Score A reflects the lipoatrophy or fat loss perception at the face, arms, buttocks and legs and ranges from 0-12.~Score B reflects the perception of fat gain at the abdomen, neck, and breasts and ranges from 0-9.~The overall score is the sum of the scores A+B, and ranges from 0-21.~Higher numbers indicate more fat loss (Score A) or gain (Score B). An average overall patient/physician score >7 indicates a clinical diagnosis of lipodystrophy."|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each score for each group of participants is shown as N (EFV and then LPV/r)."|||units on a scale||Standard Deviation|Mean
2711862|NCT01159743|Secondary|Distribution of Body Fat Mass|Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each category for each group of participants is shown as N (EFV and then LPV/r)."|||kg||Standard Deviation|Mean
2711863|NCT01159743|Primary|Total Limb Fat Mass|Total limb fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. DEXA uses a whole body scanner and two different low-dose x-rays to read bone mass and soft tissue mass.|Study visit|All participants for whom data were available.|||kg||Standard Deviation|Mean
2711864|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3|"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied."|At Visit 3 (after approximately 6 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.|||participants|||Number
2711865|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2|"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied."|At Visit 2 (after approximately 2-4 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.|||participants|||Number
2711866|NCT01159691|Primary|Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints|"Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day).~For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12).~Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement."|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2711867|NCT01159691|Primary|Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)|Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.|||millimeter (mm)||Standard Deviation|Mean
2711868|NCT01159665|Other Pre-specified|Time Necessary to Remove the Vitreous From the Eye|PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated.|From first start of vitrectomy cutter till the end of core vitrectomy phase|Safety Set|||Minutes||Standard Deviation|Mean
2711869|NCT01159665|Primary|Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.|Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 [5-30 minutes]; Group 2 [31-60 minutes]; Group 3 [2-4 hours]; Group 4 [24 hours ±2 hours]; Group 5 [7 days ±1 day]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.|5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection|Safety Set. Values for the PPV 7 days (+1 day) after injection and for PPV without injection treatment groups were all < Lower Limit of Quantification (LLOQ)|||ng/mL||Standard Deviation|Mean
2711870|NCT01159600|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic events, as reported as adverse events.|From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days|"Treated set, which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.~Open label set which included all patients entered into the open-label arm."|||percentage of participants|||Number
2711959|NCT01158703|Secondary|Incidence of Bleeding Between the Two Treatment Arms||52 weeks||||BLEEDING EVENTS|||Number
2711991|NCT01158157|Primary|Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration||Days 0 to 90 post-vaccination|Post-vaccination adverse events were assessed in the safety population.|||percentage of participants|||Number
2711871|NCT01159600|Primary|HbA1c Change From Baseline|"Change from baseline in HbA1c after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||percentage of HbA1c||Standard Error|Mean
2711872|NCT01159600|Secondary|Mean Daily Plasma Glucose (MDG) Change From Baseline|"Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||mg/dL||Standard Error|Mean
2711873|NCT01159600|Secondary|Body Weight Change From Baseline|"Body weight change from baseline after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||kg||Standard Error|Mean
2711874|NCT01159574|Secondary|Time to Disease Progression (Progression Free Survival)||From start of treatment, to date of disease progression|18 patients were removed from study for reasons other then disease progression; 2 patients are still receiving treatment.|||days||Full Range|Mean
2711875|NCT01159574|Secondary|Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response||From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days||||cycles||Full Range|Mean
2711876|NCT01159574|Primary|Overall Response Rate|Best response rate was recorded for all patients, using the IMWG criteria.|from baseline to cycle with maximum response, which was achieved on average after 2 cycles||||Participants|||Count of Participants
2711877|NCT01159535|Primary|Mean Number of Alcohol and Drug Use Days Out of Past 30|Self reported use of alcohol and or illicit substances over the previous 30 days|30 days previous, assessed at 12-month follow-up||||number of days out of past 30||Standard Deviation|Mean
2711878|NCT01159431|Secondary|Mood|Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.|18-weeks||||units on a scale||Standard Deviation|Mean
2711879|NCT01159431|Primary|Change in Seizure Frequency|Percent change in seizure frequency from baseline|18 weeks||||percentage change in seizures per month||Standard Deviation|Median
2711880|NCT01159431|Secondary|Response Ratio: Mean Percent Change in Seizures|Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.|18 weeks||||percentage change of RRATIO||Standard Deviation|Mean
2711881|NCT01159431|Primary|Time to the 4th Seizure|Number of Days to the 4th seizure|treatment period (18-weeks)||||days||Standard Deviation|Mean
2711882|NCT01159431|Primary|50% Responder Rate|"Change in responder rate, at end of study (18 weeks)~Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage."|Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks||||percentage of participants|||Number
2711883|NCT01159262|Secondary|Time to Successful Extubation in DEX-exposed Subjects||From start of DEX administration to extubation of each subject up to 7 days post-infusion|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.|||hour||95% Confidence Interval|Median
2711884|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion|||milligram/Kg||Standard Deviation|Mean
2711885|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion|||microgram/Kg||Standard Deviation|Mean
2711886|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion|||milligrams/Kg||Standard Deviation|Mean
2711887|NCT01159262|Secondary|Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion|||milligram||Standard Deviation|Mean
2711888|NCT01159262|Secondary|Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion|||Microgram||Standard Deviation|Mean
2711889|NCT01159262|Secondary|Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During Study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion|||Milligram||Standard Deviation|Mean
2711890|NCT01159262|Secondary|Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion||During Study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.|||percentage of subjects|||Number
2711894|NCT01159171|Secondary|Time to Progression|TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||months||Standard Deviation|Mean
2711895|NCT01159171|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months|TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||percentage of participants|||Number
2711896|NCT01159171|Secondary|Time to Treatment Failure|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||months||Standard Deviation|Mean
2711897|NCT01159171|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every month to end of treatment (up to 24 months)|ITT Population|||percentage of participants|||Number
2711898|NCT01159171|Secondary|Duration of Stable Disease|Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.|||months||Standard Deviation|Mean
2711899|NCT01159171|Primary|Percentage of Participants by Best Overall Response|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.|||percentage of participants|||Number
2711900|NCT01159171|Secondary|Duration of Stable Disease - Percentage of Participants With an Event by 24 Months|Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.|||percentage of participants|||Number
2711901|NCT01159171|Secondary|Duration of Response|Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.|||months||Standard Deviation|Mean
2711902|NCT01159171|Secondary|Duration of Response - Percentage of Participants With an Event by 24 Months|Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT population; only participants with a best overall response of CR or PR were included in the analysis.|||percentage of participants|||Number
2711920|NCT01158976|Secondary|Infant's Receptive Communication Scaled Score|"Scaled Score on Receptive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child understands spoken words and directions compared to a group of children within the same age range from across the United States. Subscale consists of 49 items. Child'e scaled score is calculated from total raw scores.~Scaled score range: 1 - 12 Lower scores indicate more developmental delay."|3 months old||||units on a scale||Standard Deviation|Mean
2711987|NCT01158261|Primary|Specific Safety Parameters|"Incidence of graft occlusion~Incidence of adverse events potentially related to non-graft thrombotic events~Incidence of bleeding events"|Up to 4-weeks post-operatively|From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.|||participants|||Number
2711903|NCT01159171|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.|||percentage of participants|||Number
2711904|NCT01159067|Secondary|Correlation of LPI With Serum Ferritin|Both LPI and Serum Ferritin levels are measured at screening (baseline), week 4, 12, 24 and end of study. The correlation between the levels of LPI and Serum Ferritin at screening, week 4, 12, 24 and end of study will be examined and plotted.|Assessed through 6 months from the start of treatment|The enrolled patient's LPI level at baseline is below 0.5 umol/L and she had both LPI and Serum Ferritin levels measured at baseline only. Therefore, no sufficient data to estimate the correlation of LPI with Serum Ferritin.||||||
2711905|NCT01159067|Secondary|Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment|Number of patients, whose Serum Ferritin levels are lower than 1500 ng/mL at two consecutive study visits. Serum Ferritin levels are measured at screening (baseline), week 4, 8, 12, 16, 20, 24 and end of study.|Assessed through 6 months from the start of treatment||||Participants|||Count of Participants
2711906|NCT01159067|Secondary|Number of Patients With LPI Below 0.5 Umol/L After Treatment|In patients with LPI values above threshold 0.5umol/L at baseline, number of patients had LPI suppressed below this value after treatment. Measurement of LPI is done on plasma specimens.|Assessed through 6 months from the start of treatment|No patient had elevated LPI level above 0.5umol/L at baseline.||||||
2711907|NCT01159067|Primary|Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)||At baseline||||Participants|||Count of Participants
2711908|NCT01159054|Secondary|Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).|The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)|6 months (checked monthly)||||Participants|||Number
2711909|NCT01159054|Secondary|Hemodialysis Access Stenosis/Thrombosis|Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study.||||||
2711910|NCT01159054|Secondary|Rate of Cardiovascular Events|Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study.||||||
2711911|NCT01159054|Secondary|Hemoglobin Level|Pre and Post Levels|6 months|Only 2 subjects completed the study. Further analysis was not done because power was not met.|||g/dL||Full Range|Mean
2711912|NCT01159054|Secondary|ESA (Erythorpoietic Stimulating Agent) Dose Requirement|Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected.||||||
2711913|NCT01159054|Secondary|Albumin Level|Pre and Post levels.|6 months|Only 2 subjects completed the study. Further analysis was not done because power was not met.|||g/dL||Full Range|Mean
2711914|NCT01159054|Primary|Changes in IL-6 Level|Change in IL-6 level before and after treatment in each subject|6 months|Only 2 subjects completed the study. Further analysis not done because power was not met.|||pg/mL||Full Range|Mean
2711915|NCT01159054|Primary|Changes in Hs-CRP Level|Change in hs-CRP level before and after treatment in each subject|6 months|Only 2 subjects completed the study. Power for further analysis was not met.|||mg/L||Full Range|Mean
2711916|NCT01159054|Primary|Changes in FDG-PET/CT Dual Scan Score||6 months|Analysis of images for this outcome measure was not done given than only 2 subjects had completed the study at the time of the study early termination and closure (per funding source)||||||
2711917|NCT01158976|Secondary|Infant's Gross Motor Skills Scaled Score|"Infants Gross Motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child well your child can move his or her body compared to a group of children within the same age range from across the United States. Subscale consists of 72 items. Child's scaled score is calculated from total raw scores.~Scaled score range: 1 - 6 'Lower scores indicate more developmental delay."|Approximately 3 months of age|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711918|NCT01158976|Secondary|Infant's Fine Motor Skills Scaled Score|"Fine motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child recognizes sounds and how much a child can use his or her hands and fingers to do things compared to a group of children within the same age range from across the United States. Subscale consists of 66 items. Child's scaled score is calculated from total raw scores.~Scaled score range: 1 - 8 Lower scores indicate more developmental delay."|Approximately 3 months of age|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711919|NCT01158976|Secondary|Infant's Expressive Communication Scaled Score|"Scaled Score for Expressive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child communicates using sounds, gestures, or words compared to a group of children within the same age range from across the United States. Subscale consists of 48 items. Child'e scaled score is calculated from total raw scores.~Scaled score range: 2 - 9 Lower scores indicate more developmental delay."|At approximately 3 months of age|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711954|NCT01158716|Primary|Delta Cardiac Troponin I (ΔcTnI)|ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography|24 hours post PCI||||ng/mL||Inter-Quartile Range|Median
2711921|NCT01158976|Secondary|Gestational Age (GA)|Gestational Age at time of birth Total sample range: 27.60 to 41.60 weeks Below 37 considered premature Mothers typically induced after 41 weeks due to increased pregnancy risks after this time|Time of birth, total sample range: 27.60 to 41.60 weeks gestation|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||Weeks||Standard Deviation|Mean
2711922|NCT01158976|Secondary|Percentage of Infants Who Had a 1-minute Apgar Scores of 9|Percentage of infants who had a 1-minute Apgar scores of 9 Sub scores from 5 categories( Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color) are added together Score range: 1-10 A higher score is better where 7,8,9 are normal|Time of birth, total sample range: 27.60 to 41.60 weeks gestation|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||percentage of infants|||Number
2711923|NCT01158976|Secondary|Infant Birth Weight|Weight of infant|Time of birth, total sample range: 27.60 to 41.60 weeks gestation|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||grams||Standard Deviation|Mean
2711924|NCT01158976|Secondary|Maternal Perceived Stress Scale Score|"Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 30 weeks gestation.~There are 10 questions in this scale and they all refer to typical life stressors.~Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress"|30 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711925|NCT01158976|Secondary|Maternal Perceived Stress Scale Score|"Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 24 weeks gestation.~There are 10 questions in this scale and they all refer to typical life stressors.~Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress"|24 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711926|NCT01158976|Secondary|Maternal Perceived Stress Scale (PSS) Score|"Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at baseline. There are 10 questions in this scale and they all refer to typical life stressors.~Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress"|Baseline: 16 - 21 weeks|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711927|NCT01158976|Secondary|Maternal Depression Symptoms|"Maternal depression symptoms at 30 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.~Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity."|30 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711928|NCT01158976|Secondary|Maternal Depression Symptoms|"Maternal depression symptoms at 24 weeks gestation as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.~Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity."|24 weeks|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711929|NCT01158976|Secondary|Maternal Depression Symptoms|"Maternal depression symptoms at 16 to 24 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.~Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity."|16-21 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
2711930|NCT01158976|Primary|Infant Cortisol Levels|Infant cortisol response to the Still-Face paradigm 45 mins post-stressor|4 months post-partum|The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
2711931|NCT01158976|Primary|Infant Cortisol Levels|Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor|4 months post-partum|The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
2711932|NCT01158976|Primary|Infant Cortisol Levels|Infant cortisol response to the Still-Face paradigm before stressor|4 months post-partum|The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
2711933|NCT01158976|Primary|Maternal Cortisol Levels|Maternal stress regulation at 30 weeks gestation|45 minutes post stressor|The analysis population reflects those participants who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
2711934|NCT01158976|Primary|Maternal Cortisol Levels|Maternal stress regulation at 30 weeks gestation|20 minutes post-stressor|The analysis population reflects those participants who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
2711935|NCT01158976|Primary|Maternal Cortisol Levels|Maternal stress regulation at 30 weeks gestation|Baseline (pre-stressor)|The analysis population reflects those participants who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
2711955|NCT01158703|Secondary|Number of Thrombotic Events|Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants|||thrombotic Events over 52Wks|||Number
2711992|NCT01158118|Secondary|Death of Any Cause (Recipients Only)||Up to 1 year||||Participants|||Count of Participants
2711936|NCT01158924|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population|||units on a scale||Standard Deviation|Mean
2711937|NCT01158924|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
2711938|NCT01158924|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population|||participants|||Number
2711939|NCT01158924|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
2711940|NCT01158924|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total)."|||participants|||Number
2711941|NCT01158885|Secondary|Occurrence of Toxicity During Hematopoietic Cell Transplant (HCT) for Patients Who Achieve Remission and Proceed to Transplant|After the patient completes therapy on this protocol, data will continue to be collected regarding whether the patient proceeded to HCT. Toxicity and adverse event information will be collected.|Every 3 months for life following completion of protocol therapy.|None of the patients treated on Treatment Course 1 proceeded to HCT. 1 patient upon completion of Treatment Course 1 proceeded with Bone Marrow Transplant and 1 patient was removed early from protocol treatment during Course 1 due to progressive disease.||||||
2711942|NCT01158885|Secondary|Occurrence of a Dose-Limiting Toxicity|All toxicities and adverse events will be collected from the first dose of study drug until 30 days following the last dose of Clofarabine|Beginning with the first dose of investigational product until 30 days following the last dose of clofarabine|All patients treated on Treatment Course 1.|||Participants|||Count of Participants
2711943|NCT01158885|Primary|Minimal Residual Disease (MRD)|To be assessed in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. Patient's bone marrow will be evaluated for the amount of minimal residual disease (MRD) present after treatment on courses 1 and 2.|Sample collected between Days 22-36 of courses 1 and 2|Study was closed prematurely and none of the patients treated were eligible for analysis of disease response.||||||
2711944|NCT01158820|Secondary|Endoscopist Satisfaction|Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)|After the bronchoscopy procedure only||||score on a scale||Inter-Quartile Range|Median
2711945|NCT01158820|Secondary|Patient Satisfaction|Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)|After the bronchoscopy procedure only||||score on a scale||Inter-Quartile Range|Median
2711946|NCT01158820|Secondary|Conversion to General Anesthesia|Patients in which the procedure could not be completed without conversion to general anesthesia|During the bronchoscopy procedure only, 58.5 minutes average||||Participants|||Count of Participants
2711947|NCT01158820|Secondary|Desaturation (Longest)|Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)|During the bronchoscopy procedure only, 58.5 minutes average||||seconds||Inter-Quartile Range|Median
2711948|NCT01158820|Secondary|Desaturation (Cumulative)|Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%|During the bronchoscopy procedure only, 58.5 minutes average||||seconds||Inter-Quartile Range|Median
2711949|NCT01158820|Primary|Total Midazolam|Total midazolam delivered during procedure|Duration of procedure||||mg||Inter-Quartile Range|Median
2711950|NCT01158820|Primary|Total Fentanyl|Total fentanyl dose delivered during the procedure|During the bronchoscopy procedure only, 58.5 minutes average||||µg||Inter-Quartile Range|Median
2711951|NCT01158820|Primary|Decreased Minute Ventilation|An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.|During the bronchoscopy procedure only, 58.5 minutes average||||percentage of baseline||Inter-Quartile Range|Median
2711952|NCT01158716|Secondary|ECG Evidence of Ischemia During Coronary Balloon Occlusion|ST-segment deviation as monitored during coronary balloon occlusion|During coronary balloon occlusion|||||||
2711953|NCT01158716|Secondary|Chest Pain During Coronary Balloon Occlusion|Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)|During coronary balloon occlusion|||||||
2711960|NCT01158703|Primary|Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo|52 weeks|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo|||occluded grafts|Participants||Number
2711961|NCT01158651|Secondary|Common Terminology Criteria for Adverse Events (CTCAE) Events|Number of participants experiencing serious CTCAE events in the study.|approximately 48 weeks||||participants|||Number
2711962|NCT01158651|Primary|RAD001 Response Rate Based on 2D MRI Change From Baseline|Outcome is 2D MRI target tumor volume compared to baseline volume. Success criteria is volume less than 80% of baseline.|Approximately 48 weeks|Intent to treat|||participants||95% Confidence Interval|Number
2711963|NCT01158573|Primary|Ratio U Cys-LT/FeNO|Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio|sample taken over 5 minutes or less||||ratio||Standard Deviation|Mean
2711964|NCT01158573|Primary|Urine Cysteinyl Leukotriene Per Creatinine|Urine inflammatory mediators measured from a single urine sample|sample taken over 5 minutes or less||||pg/mg creatinine||Standard Deviation|Mean
2711965|NCT01158573|Primary|Exhaled Nitric Oxide (FeNO)|Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)|Observational: Two exhalations within 1 minute||||parts per billion (ppb)||Standard Deviation|Mean
2711966|NCT01158573|Primary|Plasma Leptin|Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.|Observational: one time point from a blood draw after more than 6 hours fasting||||ng/ml||Standard Deviation|Mean
2711967|NCT01158534|Secondary|Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months|To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.|at two months from start of treatment|Patients that received treatment|||participants|||Number
2711968|NCT01158534|Secondary|Progression-free Survival|Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.|to progression||||months||95% Confidence Interval|Median
2711969|NCT01158534|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.|end of study|Patients who achieved at least a partial response|||months||Full Range|Median
2711970|NCT01158534|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method.|death||||months||95% Confidence Interval|Median
2711971|NCT01158534|Primary|Objective Response Rate Assessed by RECIST Criteria.|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.|at week 4 of cycle 2 and every other cycle thereafter||||participants|||Number
2711972|NCT01158521|Secondary|Reduction in Tumor Volume After Treatment|Median (cm^3) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment).|After 8 to 16-weeks of pazopanib treatment||||cm^3||Inter-Quartile Range|Mean
2711973|NCT01158521|Secondary|Surgical Morbidity|Conversion of tumor post therapy so that there is < 10% risk that a partial nephrectomy would be associated with a high risk of significant postoperative morbidity (e.g. conversion of tumor post therapy to ≥ 3 mm away from renal hilum (main renal artery, renal vein, or primary branches)|post-surgery||||Participants|||Count of Participants
2711974|NCT01158521|Secondary|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Target Lesions: Complete Response, Partial Response, Overall Response (OR)=CR+PR|Efficacy of pazopanib was evaluated via the Response Evaluation Criteria in Solid Tumors, version 1.1. Assessed by MRI. Definitions of response include Complete Response (CR), Disappearance of target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR|At the end of 8 to 16-weeks of treatment||||Participants|||Count of Participants
2711975|NCT01158521|Secondary|Change in Tumor Diameter|Median (cm) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment).|At the conclusion of 8 to 16-week treatment with pazopanib therapy.||||cm||Inter-Quartile Range|Median
2711976|NCT01158521|Secondary|Residual Vascularized Parenchyma After Pazopanib Therapy and Subsequent Surgery Relative to Pre-therapy Assessment.|Measurement of total parenchymal tissue that could be saved with pazopanib therapy and subsequent surgery, which was performed via a volumetric analysis of CT images.|After 8 to 16-weeks of pazopanib therapy and 7 day washout prior to surgery.||||cm^3||Inter-Quartile Range|Mean
2711977|NCT01158521|Primary|Number of Participants Who Could Undergo Partial Nephrectomy After Pazopanib Therapy|The primary end point was the percentage of patients who could undergo partial nephrectomy after pazopanib therapy. A reduction in tumor size, with pazopanib treatment, may permit the use of a partial nephrectomy, as opposed to a radical nephrectomy. This would help preserve additional vascularized parenchyma.|Partial nephrectomy performed after 8 to 16-weeks of pazopanib prescription. The median interval from treatment start to surgery was 10.6 weeks.||||Participants|||Count of Participants
2711978|NCT01158404|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY900009|The geometric mean Cmax for each dose group is reported following a single dose of LY900009.|Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose|All enrolled participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate Cmax.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2711988|NCT01158222|Secondary|Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype||Day 28 of each cycle|Did not complete this analysis. Data not collected.||||||
2711979|NCT01158404|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve of LY900009 From Time Zero to Infinity [AUC(0-infinity)]|The geometric mean AUC(0-infinity) for each dose group is reported following a single dose of LY900009.|Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dose|All enrolled participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate AUC(0-infinity).|||nanograms*hour/milliliters (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2711980|NCT01158404|Secondary|Percentage of Participants With a Best Overall Response of Stable Disease or Better (Document the Antitumor Activity)|Best overall response of stable disease or better is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.1). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Percentage of Participants with a best overall response of SD or better is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100.|Baseline to measured progressive disease up to 15.1 weeks|All enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2711981|NCT01158404|Secondary|Recommended Dose Range for Phase 2 Studies|Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). MTD is the highest dose with <33% of participants having a dose-limiting toxicity (DLT) during Cycle 1. DLT is an adverse event (AE) occurring for a participant enrolled in Part A that is likely related to the study drug and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 4.02) Grade 3 or 4 nonhematologic toxicity except for Grade 3 nausea, vomiting or electrolyte disturbance; Grade 3 nausea, vomiting or electrolyte disturbance that persists more than 2 days despite maximal supportive intervention; Grade 4 hematological toxicity that persists more than 5 days; Grade 3 or 4 thrombocytopenia with bleeding; Grade 3 or 4 neutropenia with fever. A DLT can be declared if a participant experiences increasing toxicity during treatment.|Predose up to 28 days in Cycle 1|All enrolled participants who received at least one dose of study drug during dose escalation phase.|||milligrams (mg)|||Number
2711982|NCT01158404|Primary|Number of Participants With Clinically Significant Effects|Clinically significant effects are study drug related serious adverse events (SAEs) and study drug related treatment emergent adverse events (TEAEs). A summary of all SAEs and all other non-SAEs regardless of causality is located in the Reported Adverse Events module.|Baseline to study completion up to 18.7 weeks|All enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
2711983|NCT01158378|Secondary|Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.|Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.|120 days|Includes all subjects with available data that through 120 days follow-up.|||percentage of subjects|||Number
2711984|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 45 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period."|45 days|All subjects who received treatment with evaluable 45-day follow-up data.|||percentage of subjects||95% Confidence Interval|Number
2711985|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 14 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period."|14 days|All subjects who received treatment with evaluable 14-day follow-up data.|||percentage of subjects||95% Confidence Interval|Number
2711986|NCT01158378|Primary|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period."|120 days|All subjects who received treatment with evaluable 120-day follow-up data.|||percentage of subjects||95% Confidence Interval|Number
2711989|NCT01158222|Secondary|Change in Circulating Tumor Cells||Pre-treatment, day 1, and day 28 of every cycle|Did not complete this analysis. Data not collected.||||||
2711994|NCT01158118|Secondary|Transplant Related Mortality (Recipient Only)|Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.|100 days||||Participants|||Count of Participants
2711995|NCT01158118|Secondary|Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)|Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).|Day 100-1 year|6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.|||Participants|||Count of Participants
2711996|NCT01158118|Secondary|Rate of Acute Graft vs. Host Disease (GvHD) (Recipient Only)|-Incidence and severity of acute GVHD will be assessed based on the Seattle criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).|Up through Day 100|3 of the recipients received cells mobilized by 10 mcg/kg of GM-CSF and the 11 recipients received stem cells from donors mobilized with the decreased dose of 5 mcg/kg of GM-CSF.|||Participants|||Count of Participants
2711997|NCT01158118|Secondary|Kinetics of Immune Reconstitution as Measured by Time to Platelet Engraftment (Recipient Only)|-Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/ul without platelet transfusion support for 7 days.|Up to Day 180|1 recipient did not have platelet engraftment by Day 180 and is not evaluable for this outcome measure.|||days||Full Range|Median
2711998|NCT01158118|Secondary|Kinetics of Immune Reconstitution as Measured by Time to Neutrophil Engraftment (Recipient Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.|Up to Day 100||||days||Full Range|Median
2711999|NCT01158118|Secondary|Determine if Peripheral Blood Stem Cell Products Collected After Mobilization With IV Plerixafor Can be Used Safely for Hematopoietic Cell Transplantation in HLA-matched Recipients as Measured by Time to Neutrophil Engraftment (Recipient Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.|Up to Day 21||||Participants|||Count of Participants
2712000|NCT01158118|Secondary|Percentage of Donors Who Reach 5x10^6 CD34+ Cells/Kg Recipient Weight in 1 or 2 Aphereses|-The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. The percentage of donors who reach at least 5x10^6 CD34+ cells/Kg recipient weight will be analyzed for this outcome measure.|6 days|-If patients achieved ≥ 2x10^6 CD34+ cells/Kg, they were not required to go on to a second day of collection|||Participants|||Count of Participants
2712001|NCT01158118|Secondary|Number of Donors Who Mobilize ≥ 2x10^6 CD34+ Cells/Kg Recipient Weight Safely Following One or Two Aphereses|-The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. If it contains at least 2x10^6 CD34+ cells/kg, then the procedure will be considered successful.|Up to 6 days||||Participants|||Count of Participants
2712002|NCT01158118|Secondary|Proportion of Donors Who Experience Grade 3-4 Infusion Toxicity|Infusional toxicity will be evaluated by measuring the patient's blood pressure, heart rate, respirations and temperature one hour prior to the allograft infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours, and 6 hours post infusion. Donors will have vital signs collected at each time point. EKGs will be performed immediately prior to IV AMD3100 and one hour after infusion.|30 days after completion of therapy (estimated to be 36 days)||||Participants|||Count of Participants
2712003|NCT01158118|Primary|Number of Donors Requiring a Second Collection to Obtain a Minimum CD34/Kg (2 x 10^6) Necessary for Allogeneic Stem Cell Transplantation|The primary endpoint is to reduce the number of donors treated with GM-CSF who require a second collection to obtain a minimum CD34/Kg (2 x 106) necessary for allogeneic stem cell transplantation when compared to historic controls mobilized with GM-CSF or plerixafor alone. A reduction in failed first leukapheresis from 40% to less than 10% as seen with G-CSF alone would be considered clinically meaningful.|Up to 6 days||||Participants|||Count of Participants
2712004|NCT01157897|Secondary|Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population|Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '>50' were converted to '1'.|study duration|Efficacy population|||Geometric Mean Titier of European Units||95% Confidence Interval|Mean
2712005|NCT01157897|Secondary|Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population|Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '>50' were converted to '1'.|study duration|Immunogenicity population|||Geometric Mean Titer of European Units||95% Confidence Interval|Mean
2712006|NCT01157897|Secondary|Time to Parasitemia for Immunogenicity Population|"Subjects were ranked according to time of onset of parasitemia and a non-parametric rankorder statistical test (eg, Log-Rank or Mann-Whitney) was performed to evaluate delays in parasitemia induced by vaccination. Cox Proportional Hazards model was used to calculate days to parasitemia and Kaplan-Meier plots were used to display time to first positive malaria blood smear.~Hazard Ratio (HR). Time starts once subject has received t infectious bites. Time stops when subject has first positive blood smear. If subject does not become parasitemic then time stops the day he/she begins anti-malarial therapy."|280 day (during the study through 6 months aftr challenge)|Drop-outs prior to vaccination were not included in the analysis|||days||Standard Error|Mean
2712007|NCT01157897|Primary|Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)|Occurrence of serious adverse events at any time during the approximately 463 day study period|up to 463 days||||Participants|||Count of Participants
2712008|NCT01157897|Primary|Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase|Adverse events were evaluated over a 28 day follow-up period after each vaccination during the vaccine phase|28 days following immunization|Control group was not included in this evaluation.|||participants with AEs|||Number
2712009|NCT01157897|Primary|Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase|Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.|7 days after immunization|Control group was not included in the evaluation.|||participants with AEs|||Number
2712010|NCT01157845|Secondary|Liver Transplantation|Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation|1 year||||participants|||Number
2712011|NCT01157845|Primary|Mortality From Liver Failure|Patient dies of liver-related causes within 1 year of study entry|1 year||||participants|||Number
2712012|NCT01157676|Secondary|Cost|Fixed and variable costs associated with the procedure.|Day 7|Cost data was specified as a secondary endpoint in the protocol, but data could not be collected from all sites due to proprietary reasons.||||||
2712013|NCT01157676|Primary|Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire|FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy [FACT-BL-Cys]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing.|baseline, 3 months, 6 months|Not all participants completed the questionnaire at the different visits.|||score on a scale||95% Confidence Interval|Mean
2712014|NCT01157676|Primary|Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test|The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again.|baseline, 1 month, 3 months, 6 months|Number of participants included was based on the data available at specific time points.|||seconds||95% Confidence Interval|Mean
2712015|NCT01157676|Primary|Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test|The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.|baseline, 1 month, 3 months, 6 months|Number of participants included was based on the data available at specific time points.|||kg||95% Confidence Interval|Mean
2712016|NCT01157676|Primary|Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire|Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.|baseline, 1 month, 3 months, 6 months|Number of participants included was based on the data available at specific time points.|||score on a scale||95% Confidence Interval|Mean
2712017|NCT01157676|Primary|Creatinine Value.|Serum creatinine will be reported in milligrams per deciliters (mg/dL).|baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months|Number of participants included was based on the data available at specific time points.|||mg/dL||Standard Deviation|Mean
2712018|NCT01157676|Primary|Total Postoperative Analgesic Requirements|Total postoperative analgesic requirements in milli grams|At time of cystectomy, approximately 1 hour||||mg||Standard Deviation|Mean
2712019|NCT01157676|Primary|Total Number of Participants Requiring Intra-operative Fluid Requirement|Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion.|At time of cystectomy, approximately 1 hour|Number of participants included was based on the data available at specific time point.|||Participants|||Count of Participants
2712020|NCT01157676|Primary|Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire|The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health.|baseline, 3 month, and 6 month|Number of participants changes depending on their data availability at different time points.|||percentile||95% Confidence Interval|Mean
2712021|NCT01157676|Primary|Percentage of Participants With 3-year Progression Free Survival (PFS)|Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.|3 years||||Percent of participants||95% Confidence Interval|Number
2712022|NCT01157676|Primary|Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire|Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.|baseline, 1 month , 3 months, 6 months|Number of participants changes depending on their data availability at different time points.|||score on a scale||95% Confidence Interval|Mean
2712023|NCT01157676|Primary|Laboratory Values|Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)|baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months|Number of participants included was based on the data available at specific time points.|||g/dL||Standard Deviation|Mean
2712024|NCT01157676|Primary|Length of Operative Time|Length of minutes of cystectomy procedure|At time of cystectomy, approximately 1 hour|The length of operative time is not available for all participants.|||minutes||95% Confidence Interval|Mean
2712025|NCT01157676|Primary|Number of Days of Post Operative Length of Hospital Stay|Number of days of post operative length of hospital stay will be evaluated|Day 10 post surgery|Not all length of stay data is available for all the study participants.|||days||95% Confidence Interval|Mean
2712026|NCT01157676|Primary|Number of Participants Requiring Blood Transfusion|Number of participants requiring peri, intra, and post operative blood transfusion.|At time of cystectomy, approximately 1 hour|Not all participants in the study required blood transfusion and not all blood transfusion data was available.|||Participants|||Count of Participants
2712027|NCT01157676|Primary|Amount of Estimated Blood Loss (EBL) in ml|Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.|At time of cystectomy, approximately 1 hour|EBL data was not available on 3 of the open radical cystectomy and 2 of the RARC participants.|||ml||95% Confidence Interval|Mean
2712028|NCT01157676|Primary|Number of Participants With Post-surgical Complications|Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications.|90 days post operative|90 day complication using Clavien Grading system|||Participants|||Count of Participants
2712029|NCT01157676|Primary|Quality of Life (QOL) Outcomes|Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL.|at baseline, 3 month, and 6 months|Not all enrolled participants completed the QOL questionnaires.|||score on a scale||95% Confidence Interval|Mean
2712030|NCT01157676|Primary|Number of Participants Requiring Lymph Node Dissection|Evaluated are the number of participants requiring extended or standard lymph node dissection|At time of cystectomy, approximately 1 hour|1 participant in the RARC group did not have lymph node dissection.|||Participants|||Count of Participants
2712031|NCT01157676|Primary|Number of Participants With Positive Margins|Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue.|At time of cystectomy, approximately 1 hour.||||Participants|||Count of Participants
2712032|NCT01157676|Primary|Percentage of Participants With 2-year Progression Free Survival (PFS)|Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease.|24 months||||percentage of participants||95% Confidence Interval|Median
2712033|NCT01157533|Primary|Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose|Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours).|Up to 5 days|Unable to complete analysis planned due to low enrollment.||||||
2712034|NCT01157429|Primary|Child PTSD Symptom Scale (CPSS)|The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).|After 12 therapy sessions, up to 28 weeks.||||units on a scale||Standard Deviation|Mean
2712035|NCT01157416|Primary|Child PTSD Symptom Scale (CPSS)|The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).|After 12 therapy sessions, up to 28 weeks.||||units on a scale||Standard Deviation|Mean
2712036|NCT01157377|Primary|Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes|The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).|Baseline, Week 12|Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.|||Episodes||Standard Deviation|Mean
2712037|NCT01157364|Secondary|Time to Rescue Treatment or Re-Treatment in the Study Eye|Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.|24 Months|Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16|||Days||Full Range|Median
2712038|NCT01157364|Secondary|Mean Diurnal IOP in the Study Eye|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.|Baseline, Month 6|Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Including IOP assessments after rescue or retreatment.|||mmHg||Standard Deviation|Mean
2712039|NCT01157364|Secondary|Time-Matched Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the study eye.|Baseline to Month 6|Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2712040|NCT01157364|Primary|Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Month 24|Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2712051|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients < 50 Years Old Compared With Metoprolol in Transplant Recipients < 50 Years Old||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.|||percent change||Standard Error|Least Squares Mean
2712052|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients <50 Years Old Compared With Metoprolol in Transplant Recipients >/= 50 Years Old.||Baseline and Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.|||percent change||Standard Error|Least Squares Mean
2712041|NCT01157351|Primary|Percentage of Participants in Each Event Category of First Treatment Failure|First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||percentage of participants|||Number
2712042|NCT01157351|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration|The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2712043|NCT01157351|Secondary|Time to First Psychiatric Hospitalization|"A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the Assessment of Treatment Failure - Psychiatric Hospitalization."|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||Days||95% Confidence Interval|Median
2712044|NCT01157351|Secondary|Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration|The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2712045|NCT01157351|Secondary|Time to First Psychiatric Hospitalization or Arrest/Incarceration|A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||Days||95% Confidence Interval|Median
2712046|NCT01157351|Primary|Time to First Treatment Failure|Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.|From date of randomization up to Month 15|Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||Days||95% Confidence Interval|Median
2712047|NCT01157234|Secondary|Plasma Arginine (ARG) Level Change From Baseline to Month-12 Between Groups|Percent change in plasma Arginine (umol/L)=[month-12 plasma Arginine level minus baseline plasma Arginine level] divided by [baseline plasma Arginine level] multiplied by 100, where all levels are in umol/L|Baseline, Month-12|Technical limitations constrained measurements of plasma Arginine, resulting in no analysis for this outcome.||||||
2712048|NCT01157234|Secondary|Plasma Asymmetric Dimethylarginine (ADMA) Change From Baseline to Month 12 Between the Groups|Percent change in plasma ADMA (umol/L)=[month-12 plasma ADMA level minus baseline plasma ADMA level] divided by [baseline plasma ADMA level] multiplied by 100, where all levels are in umol/L.|Baseline, Month-12|Technical limitations constrained measurements of Asymmetric Dimethylarginine (ADMA), resulting in no analysis for this outcome.||||||
2712049|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Metoprolol in Transplant Recipients Age >/= 50 Years Old.||Change in Baseline, Month-12||||percent change||Standard Error|Least Squares Mean
2712050|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-twelve of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Nebivolol in Transplant Recipients < 50 Years Old.||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.|||percent change||Standard Error|Least Squares Mean
2712053|NCT01157234|Other Pre-specified|Plasma Nitric Oxide Level (Nmol/L) at Month-12 Between the Groups.||12 Months|Full analysis set included all participants who signed inform consent and received at least one dose of study drug|||nmol/L||Standard Error|Least Squares Mean
2712054|NCT01157234|Secondary|Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups.|Percent change in quantity of Anti-Hypertensive Drug Classes (AHDC)=[Month-12 absolute number of AHDC minus baseline absolute number of AHDC] divided by [baseline absolute number of AHDC] multiplied by 100.|Change in Baseline, Month-12|Percent change|||percent change||Standard Error|Least Squares Mean
2712055|NCT01157234|Secondary|Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|"Absolute change in Mean Arterial Blood Pressure, (MAP), (millimeter, Mercury= Month-12 sitting trough MAP minus baseline sitting trough MAP.~Mean Arterial Pressure= 2/3 trough diastolic blood pressure + 1/3 trough systolic blood pressure"|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||millimeter, Mercury||Standard Error|Least Squares Mean
2712056|NCT01157234|Secondary|Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|Absolute Change in Diastolic Blood Pressure (DBP), (millimeter, Mercury)= Month-12 sitting trough Diastolic Blood Pressure (millimeter, Mercury) level minus baseline sitting trough Diastolic Blood Pressure (millimeter, Mercury).|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||millimeter, mercury||Standard Error|Least Squares Mean
2712057|NCT01157234|Secondary|Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups|Absolute change in Systolic Blood Pressure (SBP), (millimeter, Mercury)=Month-12 sitting trough SBP level minus baseline sitting trough SBP level|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||millimeter, Mercury||Standard Error|Least Squares Mean
2712058|NCT01157234|Secondary|Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups|The changed percentage in Estimated Glomerular Filtration Rate (eGFR), (based on the Modification of Diet in Renal Disease Equation)=[Month-12 GFR level minus baseline eGFR level] divided by [baseline eGFR level] multiplied by 100, where all levels are in ml/min.|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||percent change||Standard Error|Least Squares Mean
2712059|NCT01157234|Primary|Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups.|Percent change in Nitric Oxide (NO) blood level (nmol/L)=[Month-12 NO blood level minus baseline NO blood level] divided by [baseline NO blood level] multiplied by 100, where all levels are in nmol/L.|Change in Baseline, Month-12|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.|||percent change||Standard Error|Least Squares Mean
2712060|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712061|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712062|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2712063|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712064|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712065|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2712066|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712067|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712068|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2712069|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712070|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712071|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2712072|NCT01157182|Secondary|AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712073|NCT01157182|Secondary|AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712074|NCT01157182|Secondary|Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2712075|NCT01157182|Primary|AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712076|NCT01157182|Primary|AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2712077|NCT01157182|Primary|Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2712078|NCT01157182|Primary|AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2712079|NCT01157182|Primary|AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2712080|NCT01157182|Primary|Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2712081|NCT01157169|Secondary|AUC0-inf for Norbuprenorphine.|Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2712082|NCT01157169|Secondary|AUC0-t for Norbuprenorphine.|Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2712083|NCT01157169|Secondary|Cmax for Norbuprenorphine.|Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2712084|NCT01157169|Primary|AUC0-inf for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2712085|NCT01157169|Primary|AUC0-t for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2712086|NCT01157169|Primary|Cmax of Buprenorphine.|Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2712087|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.|||percentage of CD63+ basophils||Full Range|Median
2712146|NCT01156714|Primary|Timed Instrumental Activities of Daily Living (TIADL) Function #2|The Timed IADL for Shopping involved finding two food items in an array of food items. The task was timed in seconds and if completed with minor errors, a time penalty was added to the completion time. Higher scores/times meant worse performance. The range for shopping task completion was 0.61 to 69.9 seconds.|baseline and 3 months||||seconds||Standard Error|Mean
2712088|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.|||percentage of CD63+ basophils||Full Range|Median
2712089|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.|||mgA/L||Full Range|Median
2712090|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.|||kUA/L||Full Range|Median
2712091|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.|||mgA/L||Full Range|Median
2712092|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.|||kUA/L||Full Range|Median
2712093|NCT01157117|Secondary|Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test|A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.|Month 32|All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed.|||units on a scale||Full Range|Median
2712094|NCT01157117|Secondary|Time to Maximum Tolerated Dose|Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Time to maximum tolerated dose could not be calculated because the maximum dose for the protocol was changed part way through the study after some subjects had already reached the maximum dose.||||||
2712095|NCT01157117|Secondary|Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.|Month 28|Participants who received any study treatment|||percentage of participants|||Number
2712096|NCT01157117|Secondary|Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)|Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing|||mg milk powder||Standard Deviation|Mean
2712097|NCT01157117|Secondary|Incidence of Severe Hypersensitivity Reactions to Milk OIT|Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.|Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)|Participants who received milk OIT dosing.|||percentage of participants|||Number
2712098|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.|After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30|Participants who received milk OIT dosing during the Maintenance Phase.|||percentage of participants|||Number
2712099|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Escalation Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing during the Escalation Phase.|||percentage of participants|||Number
2712100|NCT01157117|Primary|Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.|Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||Percent of participants|||Number
2712433|NCT01155024|Primary|Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting|The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)|Within the first 4-6 hrs|Per protocol analysis including all consented participants|||score on scale||Standard Deviation|Mean
2712101|NCT01157078|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712102|NCT01157078|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11-point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712103|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life.~The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712104|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life.~The 15th item queries respondents' satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712105|NCT01157078|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712106|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712107|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712108|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712266|NCT01156363|Secondary|Change in Hb Concentration Between Reference and Treatment Period|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.|||g/dL||Standard Deviation|Mean
2712109|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712110|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712111|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712112|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712113|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|"A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712114|NCT01157078|Secondary|"Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of Very Much Improved or Much Improved From Randomization (Week 8) to End of Treatment (Week 16)"|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712115|NCT01157078|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712116|NCT01157078|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712117|NCT01157078|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712434|NCT01155011|Primary|Minutes of Light to Moderate Physical Activity|Measured by 7 day accelerometry in adults, ≥65, using a 760 CPM cutpoint.|12 months||||minutes||Standard Deviation|Mean
2712118|NCT01157078|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
2712119|NCT01157078|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712120|NCT01157078|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712121|NCT01157078|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712122|NCT01157078|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712123|NCT01157065|Primary|Incidence of Events of Special Interest (ESI)|An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.|Up to Day 30|Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit|||events|||Number
2712124|NCT01157065|Primary|Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4|The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.|Week 4|All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment|||microns||Standard Deviation|Mean
2712125|NCT01156987|Primary|Lesions|Number of lesions detected|at time of read by two radiologiests, compared to biopsy within 7 days.||||lesions|||Number
2712126|NCT01156844|Secondary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 12 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
2712267|NCT01156363|Secondary|Mean Monthly Hb Values|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.|||g/dL||Standard Deviation|Mean
2712127|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 48 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
2712128|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0-24 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
2712129|NCT01156844|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline to week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
2712130|NCT01156805|Secondary|Mother's Height||every two years|Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.|||m||Standard Deviation|Mean
2712131|NCT01156805|Secondary|Father's Height||every two years|Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.|||m||Standard Deviation|Mean
2712132|NCT01156805|Secondary|Height||every two years|Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD|||m||Standard Deviation|Mean
2712133|NCT01156805|Primary|Anthropometric Variables|BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.|every two years|Qualitative variables are described in absolute and relative frequencies (percentages). Continuous variables are described as mean and SD.|||kg/m^2||Standard Deviation|Mean
2712134|NCT01156792|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period|Participants were withdrawn if they met any of the following three criteria for 'lack of efficacy': 1) Clinic FEV1 below the FEV1 'Stability Limit' value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF 'Stability Limit' for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher's Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.|Week 4 to Week 6|ITT Population.|||Number of participants|||Number
2712135|NCT01156792|Secondary|Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of nights||Standard Error|Least Squares Mean
2712136|NCT01156792|Secondary|Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period|"Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used (rescue-free nights) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant."|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of nights||Standard Error|Least Squares Mean
2712137|NCT01156792|Secondary|Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period|"Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used (rescue-free days) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant."|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
2712268|NCT01156363|Primary|Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range|Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.|Weeks 1 to 32|ITT Population.|||percentage of participants|||Number
2712138|NCT01156792|Secondary|Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period|"Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced (symptom-free nights) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant."|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of nights||Standard Error|Least Squares Mean
2712139|NCT01156792|Secondary|Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period|"Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced (symptom-free days) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant."|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
2712140|NCT01156792|Secondary|Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period|A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Number of inhalations||Standard Error|Least Squares Mean
2712141|NCT01156792|Secondary|Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period|Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2712142|NCT01156792|Secondary|Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||L/min||Standard Error|Least Squares Mean
2712143|NCT01156792|Secondary|Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||L/min||Standard Error|Least Squares Mean
2712144|NCT01156792|Secondary|Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2712145|NCT01156792|Primary|Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.|End of Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
2712147|NCT01156714|Primary|Timed Instrumental Activities of Daily Living (TIADL) Function #1|The Timed IADL involves the timing of performance of 5 tasks that mimic everyday instrumental activities of daily living: 1) finding a telephone number in the telephone directory, 2) counting out correct change from a group of coins, 3) finding then reading the ingredients on a food can label, 4) finding two food items in an array of food items (shopping), 5) finding then reading the directions on a medicine container. For each task there is a 2 minute time limit, with the exception of the telephone number task which has a limit of 3 mins. If the task is not completed within the time limit it is terminated. Error codes are assigned for each task. For the tasks completed with minor errors, a time penalty of 1 SD of those who completed the task is added to the completion time. Higher single item scores mean worse performance.The times for each of the tasks are transformed into Z scores which are then summed to form a composite score. Range for shopping item (0.61- 69.9 sec)|baseline and 3 months||||z-score||Standard Error|Mean
2712148|NCT01156714|Primary|Cognitive Function #2|The Stroop is a measure of selective attention and cognitive flexibility in which the subject must inhibit a preponderant response. Subjects are asked to complete three parts under timed conditions: (1) reading words describing colors written in black-and-white, (2) naming those colors when printed as X's, (3) naming the ink color when words describing the colors are mismatched with the colors (suppressing verbal content). Stroop interference scores from condition 3 are t-scores and higher scores equate with better outcomes.|baseline and 3 months||||t-score||Standard Error|Mean
2712149|NCT01156714|Primary|Cognitive Function #1|"2-Choice Reaction Time measures patients' ability to shift mental set. One of two stimuli are presented on the screen (+ or *). Subjects press a specified response button on the keyboard corresponding to the presented stimulus. Units are Throughput, which reflects efficiency of performance by being based on both accuracy and speed. Throughput represents correct responses/ minute."|baseline and 3 months||||correct responses/ minute||Standard Error|Mean
2712150|NCT01156714|Primary|Dual Task Function #2|"Dual task tested functional and cognitive performance while walking and talking simultaneously. Walking spatial and temporal parameters were measured using the Gaitrite 24 foot gaitmat with existing hardware and software for analysis.~Velocity was calculated by dividing the distance by the time it takes to travel that same distance, with consideration for direction. Higher values represent better outcomes. The range of scores for this study was: Pre (36.4 - 269.4), Post (76.3 - 267.6)."|baseline and 3 months|**Please note that initiation of dual-task testing was delayed by the original PI at the start of this study, such that some early participants were missed. This caused the dual-task outcome category to have lower numbers analyzed than other outcomes.|||cm/sec||Standard Error|Mean
2712151|NCT01156714|Primary|Dual Task Function #1|"Dual task tested functional and cognitive performance while walking and talking simultaneously. Walking spatial and temporal parameters were measured using the Gaitrite 24 foot gaitmat with existing hardware and software for analysis.~Cycle time refers to the amount of time taken for a participant to complete a single stride. Lower scores indicate better outcomes. The range of scores for Cycle Time is: Pre (0.73-2.47), Post (0.72-1.45)."|baseline and 3 months|**Please note that initiation of dual-task testing was delayed by the original PI at the start of this study, such that some early participants were missed. This caused the dual-task outcome category to have lower numbers analyzed than other outcomes.|||seconds||Standard Error|Mean
2712152|NCT01156701|Other Pre-specified|Number of Participants Experiencing Hospitalization or Death Due to Influenza|The frequency of hospitalization and death in the study population was analyzed.|Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712153|NCT01156701|Other Pre-specified|Number of Patients With Respiratory Outcomes||Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712154|NCT01156701|Secondary|Number of Patients With Any Respiratory Diagnosis|The frequency of any respiratory diagnosis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712155|NCT01156701|Secondary|Number of Patients With Bronchitis|The frequency of bronchitis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712156|NCT01156701|Secondary|Number of Patients With Pneumonia|The frequency of pneumonia among the four cohorts was measured..|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712157|NCT01156701|Secondary|Number of Patients With Asthma|The frequency of asthma among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712158|NCT01156701|Primary|Number of Patients With Influenza|The frequency of influenza among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
2712159|NCT01156675|Secondary|Change of Quality of Life|Change in mental or physical composite score of the short form SF36|24 months|The short form SF36 was administered to study patients; however, we do not have the proprietary scoring system. Hence the scores could not be calculated.||||||
2712435|NCT01155011|Primary|Daily Minutes of Physical Activity|Measured by 7 day accelerometry in adults, ≥65, with a 760 CPM cutpoint.|6 months||||minutes||Standard Deviation|Mean
2712436|NCT01155011|Primary|Daily Minutes of Physical Activity|Measured by 7 day accelerometry with a 760 cpm cutpoint.|Baseline||||minutes||Standard Deviation|Mean
2712160|NCT01156675|Secondary|Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months|"The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||millimeters||Standard Deviation|Mean
2712161|NCT01156675|Secondary|Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months|"The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||millimeters||Standard Deviation|Mean
2712162|NCT01156675|Secondary|Mean Visual Analog Scale (VAS) - Back Pain at 24 Months|"The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with no pain on the left border and as severe as it could be on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||millimeters||Standard Deviation|Mean
2712163|NCT01156675|Secondary|Mean Oswestry Disability Index (ODI) at 24 Months|The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. Scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability.|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||score||Standard Deviation|Mean
2712164|NCT01156675|Primary|Number of Participants With an Absence of Implant-related Complications|"Absence of implant-related complications, including device dislodgement, defined as:~Failure of implant material (e.g. fracture);~Implant migration outside of the interspinous space (posteriorly beyond the posterior margin of the spinous processes, anteriorly within the spinal canal, or laterally more than half of the implant width); or~Other complications that can be specifically associated with the implanted device."|24 months|"The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arms. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
2712165|NCT01156675|Primary|Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated|Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated.|24 months|"The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arm. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
2712166|NCT01156675|Primary|Number of Participants With a Successful Neurologic Status|"Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows:~Motor 0 Total Paralysis~Palpable or Visible Contraction~Active Movement, Gravity Eliminated~Active Movement, Against Gravity~Active Movement, Against Some Resistance~Active Movement, Against Full Resistance~Sensory 0 Absent~Impaired~Normal~Reflexes 0 Absent or Trace~Hyper-reflexic~Normal or hypo-reflexic~Straight Leg Raise 0 0°-70° (abnormal)~1 >70°-90° (normal)~If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to two less subjects having neurologic status data at 24 months in the FLEXUS arm and one less subject with neurologic status data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
2712195|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712167|NCT01156675|Primary|Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score|"Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows:~Change of >0.5 points in Physical Function on a scale of 1-4 points (lower values are considered a better outcome)~Change of >0.5 points in Symptom Severity on a scale of 1-5 points (lower values are considered a better outcome)~Satisfaction of <2.5 points on a scale of 1-4 points (lower values are considered a better outcome) The Zurich Claudication Questionnaire is a three part form that quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module. The discrepancy in the numbers is due to an additional subject having ZCQ data at 24 months in the FLEXUS arm and one less subject with ZCQ data at 24 months in the X-STOP group. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
2712168|NCT01156597|Secondary|Cholesterol Efflux Capacity of HDL|The ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420).|24 weeks||||Ratio||Standard Deviation|Mean
2712169|NCT01156597|Secondary|HDL Apolipoprotein Levels at Study End-point|Lipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined|24 weeks||||mg/dL||Standard Deviation|Mean
2712170|NCT01156597|Primary|Increased HDL-Cholesterol and Decreased Triglycerides|"The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation:~Change=[100%*(Endpoint value - Baseline Value)/Baseline Value]"|24 weeks|All subjects that completed the study were used for the final analysis|||% Change||Standard Deviation|Mean
2712171|NCT01156571|Secondary|Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild|GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial|48 hours after randomization||||participants|||Number
2712172|NCT01156571|Secondary|Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)|CEC-adjudicated results (mITT population)|48 hours after randomization||||participants|||Number
2712173|NCT01156571|Primary|The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)|Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)|48 hours after randomization||||participants|||Number
2712174|NCT01156532|Secondary|Mean Dermatology Life Quality Index (DLQI) Score Over Time|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.|||units on a scale||Standard Deviation|Mean
2712175|NCT01156532|Secondary|Mean Psoriasis Area and Severity Index (PASI) Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.|||units on a scale||Standard Deviation|Mean
2712176|NCT01156532|Secondary|Adherence to Adalimumab Treatment|Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.|up to 16 weeks|Participants who received at least one dose of study treatment.|||participants|||Number
2712177|NCT01156532|Secondary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.|From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).|Participants who received at least one dose of study treatment.|||participants|||Number
2712178|NCT01156532|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16|EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.|Baseline, Week 16|Participants with available data.|||units on a scale||Standard Deviation|Mean
2712196|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712179|NCT01156532|Primary|Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data.|||percentage of participants||95% Confidence Interval|Number
2712180|NCT01156532|Primary|Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.|||percentage of participants||95% Confidence Interval|Number
2712181|NCT01156480|Secondary|Mortality||at 40 weeks corrected gestational age|Only one subject was enrolled. Not enough data to analyze.||||||
2712182|NCT01156480|Secondary|Growth Velocity||at 40 weeks CGA|We only enrolled one subject. Not enough data to analyze.||||||
2712183|NCT01156480|Secondary|Length of Stay|this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.|at 40 weeks corrected gestational age|only one subject enrolled. Not enough data to analyze.||||||
2712184|NCT01156480|Secondary|Time to Full Enteral Feeds|this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA|at 40 weeks corrected gestational age|We only enrolled one subject. Not enough data to analyze.||||||
2712185|NCT01156480|Secondary|Time on Parenteral Nutrition||at 40 weeks corrected gestational age|Only one subject was enrolled. Not enough data to analyze.||||||
2712186|NCT01156480|Secondary|Incidence of Sepsis|We only enrolled one subject into this study and closed it due to this. I do not have any data to make a meaningful interpretation.|at 40 weeks corrected gestational age|We only enrolled one subject. Not enough data to analyze.||||||
2712187|NCT01156480|Secondary|Need for Gastrointestinal Surgery||at 36 weeks corrected gestational age|We only enrolled one subject. Not enough data to analyze.||||||
2712188|NCT01156480|Secondary|Spontaneous Intestinal Perforation|We only enrolled one subject into this study and closed it due to this. I do not have any data to make a meaningful interpretation.|at 36 weeks corrected gestational age|We only enrolled one infant. Not enough data to analyze.||||||
2712189|NCT01156480|Secondary|Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)|We only enrolled one subject into this study and closed it due to this. I do not have any data to make a meaningful interpretation.|36 weeks corrected gestational age|Only enrolled one infant. Not enough data to analyze.||||||
2712190|NCT01156480|Primary|CRP Level|C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC|7 days|This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug.|||mg/L|||Number
2712191|NCT01156480|Primary|CRP Level|C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.|3 days|This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug.|||mg/L|||Number
2712192|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712193|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712194|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712478|NCT01154634|Secondary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||nmol/L||95% Confidence Interval|Geometric Mean
2712197|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712198|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712199|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712200|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712201|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712202|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712203|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712204|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712205|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712206|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712207|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712208|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712209|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712210|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712211|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712212|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712213|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712214|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712215|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712216|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712217|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712218|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712219|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712220|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712221|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712222|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712223|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712224|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712225|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712226|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712227|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712228|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712229|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712479|NCT01154634|Secondary|Average Plasma Concentration (C Average)|Average plasma concentration|1 to 4 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||nmol/L||95% Confidence Interval|Geometric Mean
2712230|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712231|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712232|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712233|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712234|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712235|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712236|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712237|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712238|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712239|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712240|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712241|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712242|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712243|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712244|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712245|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712246|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712247|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 - Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712248|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712249|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712250|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712251|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712252|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712253|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712254|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712255|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
2712256|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 25|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712257|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 - Post-treatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712258|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 - Pretreatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712259|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 5|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712260|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 3|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712261|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 - Post-treatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712262|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 - Baseline/Pretreatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712263|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Screening|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
2712264|NCT01156363|Secondary|Percentage of Participants Requiring Dose Adjustments|Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.|Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8|ITT population. Here, number of participants analyzed signifies participants who were evaluable for this outcome and n signifies participants who were evaluable for specified time-point.|||percentage of participants|||Number
2712265|NCT01156363|Secondary|Mean Time Participants Spent Having Hb Concentration Within Target Range|Target Hb concentration was between 10.0 and 12.0 g/dL.|Weeks 1 to 32|ITT Population.|||days||Standard Deviation|Mean
2712269|NCT01156311|Other Pre-specified|Number of New or Newly Enlarging T2 Lesions|The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.|Week -8 to Week 24|Number of participants in the Gd cohort with analyzable data in both Monotherapy and Add-on Therapy Periods. Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.|||lesions per month||Standard Deviation|Mean
2712270|NCT01156311|Other Pre-specified|Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).|Week -4 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.|||lesions||Standard Deviation|Mean
2712271|NCT01156311|Other Pre-specified|Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging [MRI] scans).|Week -8 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.|||lesions||Standard Deviation|Mean
2712272|NCT01156311|Primary|Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy|Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy; n=participants in the safety population with at least 1 post-baseline value.|||percentage of participants|||Number
2712273|NCT01156311|Primary|Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy|Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.|||percentage of participants|||Number
2712274|NCT01156311|Primary|Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy|Percentage of participants with potentially clinically significant hematology laboratory abnormalities.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.|||percentage of participants|||Number
2712275|NCT01156311|Primary|Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.|AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.|||percentage of participants|||Number
2712276|NCT01156311|Other Pre-specified|Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)|Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.|from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)|The Safety Population for the Monotherapy Period was defined as any participant who took at least 1 dose of background therapy.|||percentage of participants|||Number
2712277|NCT01156142|Secondary|Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride|After each dose was administered, patients were asked if they would like to continue rinses with that particular agent. The percentage of patients who expressed an interest in continuing therapy are reported below.|Up to 9 days||||percentage of patients|||Number
2712278|NCT01156142|Secondary|Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash|The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test .|Up to 9 days||||percentage of patients|||Number
2712988|NCT01152021|Primary|Number of Adverse Events During the Sedation and Recovery Period|Adverse events will be described by type, system involvement and level of severity.|During sedation, recovery period and overnight, up to 24 hours||||Number of events|||Number
2712279|NCT01156142|Secondary|Total Drowsiness Increase|The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.|||units on a scale||Standard Deviation|Mean
2712280|NCT01156142|Secondary|Total Stinging or Burning From the Oral Rinse|The total stinging or burning from the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes any STINGING OR BURNING FROM THE ORAL RINSE now?') used 11-point numerical analog scales (0 (no stinging or burning) to 10 (worst stinging or burning possible) scores) to total stinging or burning from the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.The statistical analysis will be the same as the primary analysis.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.|||units on a scale||Standard Deviation|Mean
2712281|NCT01156142|Secondary|Total Taste of the Oral Rinse|The total taste of the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6 , and analyzed in the same way as the primary endpoint. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes the TASTE OF THE ORAL RINSE now?') used 11-point numerical analog scales (0 (acceptable taste) to 10(terrible taste), with higher values representing worse outcome) to evaluate the total taste of the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.|||units on a scale||Standard Deviation|Mean
2712282|NCT01156142|Primary|Total Pain Reduction (Mouth and Throat)|The total pain reduction will be calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your MOUTH PAIN due to your radiation treatment now?') used 11-point numerical analog scales (0 (no pain) to 10 (worst pain imaginable or possible) scores) to measure pain. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.|Baseline and Day 1|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis. The primary analysis of the total pain reduction will only use primary data from the first phase.|||units on a scale||Standard Deviation|Mean
2712283|NCT01156116|Secondary|Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2|"The average diastolic blood pressure over a 24-hr period was calculated for each patient.~Change = Week 2 - Baseline"|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.|||mmHg||95% Confidence Interval|Mean
2712284|NCT01156116|Secondary|Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2|"The average systolic blood pressure measured over a 24-hr period was calculated for each patient.~Change = Week 2 - Baseline."|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.|||mmHg||95% Confidence Interval|Mean
2712285|NCT01156116|Secondary|Change From Baseline in Insulin Sensitivity (SI) at Week 2|"SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).~Change = Week 2 - Baseline."|Baseline and Week 2|One patient from each group was excluded from the analysis since they were missing SI data at both Baseline and Week 2.|||[mU/L]^-1·[min]^-1||95% Confidence Interval|Mean
2712286|NCT01156116|Primary|Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2|"The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule .~Change = Week 2 - Baseline."|Baseline and Week 2|One patient in the Placebo group who withdrew prior to any testing was excluded from the analysis.|||(mg/dL)*min||95% Confidence Interval|Mean
2712287|NCT01156051|Secondary|Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)|Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.|||minutes||Standard Deviation|Mean
2712288|NCT01156051|Secondary|Change in Baseline to Treatment Latency to Persistent Sleep (LPS)|Change in an objective measure of sleep onset, using polysomnography.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.|||minutes||Standard Deviation|Mean
2713019|NCT01151449|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Within the protocol defined follow-up period.|Inadequate data for OS estimates as only 6 patients were accrued in the study.||||||
2712289|NCT01156051|Secondary|Change in Baseline to Treatment ADHD-Rating Scale IV Total Score|Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).|Baseline to last observation carried forward (after at least one week of dose stability)|29 children enrolled, but two were discontinued before termination data was available: one (treatment) was lost to follow up and one (placebo) was noncompliant with the protocol.|||units on a scale||Standard Deviation|Mean
2712290|NCT01156051|Primary|Change in Polysomnographic Total Sleep Time (TST)|Change in objective measures of sleep, using polysomnography|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled, one (treatment) was lost to follow up an one (placebo) was discontinued due to noncompliance with protocol.|||minutes||Standard Deviation|Mean
2712291|NCT01156012|Primary|Change From Baseline in Intraocular Pressure (IOP)|"The worse eye is defined as:~If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.~If only one eye is eligible this eye is the worse eye.~If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.~If both eyes have the same IOP at D0 the worse eye is the right eye."|Day 0 and Day 84|mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.|||mmHg||Standard Deviation|Mean
2712292|NCT01155999|Primary|The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3|Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).|Day 3|The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.|||participants|||Number
2712293|NCT01155869|Secondary|Treatment Participation|Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation|16 weeks||||percentage of visits|Participants||Number
2712294|NCT01155869|Primary|Mean Weekly Self-reported Alcohol Consumption|Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.|24 weeks||||standard drink||Standard Deviation|Mean
2712295|NCT01155830|Secondary|TNF-alpha, Maximum|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|up to 2 weeks||||pg/mL||Standard Error|Mean
2712296|NCT01155830|Primary|TNF-alpha, Baseline|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|Baseline||||pg/mL||Standard Error|Mean
2712297|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Square-root Transformed Amplitude|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Data for change from baseline in ABR square-root transformed amplitude (STA) by left and right ear were reported.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||square-root transformed(amplitude [mcV])||Standard Deviation|Mean
2712298|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Square-root Transformed Latencies|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Data for change from baseline in ABR square-root transformed latency (STL) by left and right ear were reported.|Baseline, Week 22|ITT population.Here, n = participants evaluable for specified category for each arm, respectively.|||square-root transformed (latency [ms])||Standard Deviation|Mean
2712299|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Log Transformed Amplitude|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Data for change from baseline in ABR log-transformed amplitudes (LTA) by left and right ear were reported.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||log transformed (amplitude [mcV])||Standard Deviation|Mean
2712300|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Log Transformed Latencies|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Data for change from baseline in ABR log-transformed latencies (LTL) by left and right ear were reported.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||log transformed (latency [ms])||Standard Deviation|Mean
2712301|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Amplitude Ratio|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Data for change from baseline in ABR amplitudes(A), log-transformed amplitudes (LTA), square-root transformed amplitudes (STA) by left ear (LE) and right ear (RE) wave V/I in ratio was reported.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||ratio||Standard Deviation|Mean
2712302|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Amplitudes|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Data for change from baseline in ABR amplitudes by left ear (LE) and right ear (RE) were reported.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||microvolt (mcV)||Standard Deviation|Mean
2712303|NCT01155778|Secondary|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Latencies|"ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. The Inter-peak Latencies (IPL) were calculated by subtracting the absolute latencies (AL). The Inter-aural Latencies (IAL) were calculated by subtracting the absolute wave V latencies of the right and left ear. IAL, IPL and AL were reported.~Abbreviation: Right Ear (RE), Left Ear (LE), Wave (W), Wave V (WV)"|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||millisecond (ms)||Standard Deviation|Mean
2712304|NCT01155778|Secondary|Change From Baseline in Mean Auditory Brainstem Response (ABR) at Week 22|ABR assessments were to be conducted under anesthesia and measured the electrical response evoked by acoustic stimuli as sound is processed along the auditory pathway. Mean ABR air and bone conduction threshold were assessed. Mean ABR bone conduction threshold was not possible to be reported as there was insufficient data to be analysed.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||Decibel Above Normal Adult Hearing Level||Standard Deviation|Mean
2712305|NCT01155778|Secondary|Change From Baseline in Brain Magnetic Resonance Imaging (MRI) at Week 22|Brain MRI was measured for grey matter volume (GMV) , white matter volume (WMV) and Intracranial cerebrospinal fluid Volume (ICSFV) (Ventricles + Additional CSF Space).|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||milliliter (mL)||Standard Deviation|Mean
2712306|NCT01155778|Secondary|Change From Baseline in Concentration of Heparan Sulfate and Heparan Sulfate Derivatives in Cerebrospinal Fluid (CSF) at Week 6, 10, 14, 18, 22 and 26(EOS)|"Levels of heparan sulfate and its derivatives were evaluated using the proprietary Sensi-Pro (SP) high-performance liquid chromatography (HPLC) based assay.~Abbreviation: SP Total Heparan Sulfate (SPTHS), SP Non-Reducing End Assay (SPNREA),"|Baseline, Week 6, 10, 14, 18, 22 and 26(EOS)|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||picomole per milliliter (pmol/mL)||Standard Deviation|Mean
2712307|NCT01155778|Secondary|Number of Participants With Accumulation of Recombinant Human Heparan N-Sulfatase (rhHNS) in Cerebrospinal Fluid (CSF) at Week 22|Cerebrospinal fluid samples were collected from participants through an implanted IDDD or via lumbar puncture (LP) immediately prior to each administration of HGT-1410.|Baseline, Week 22|ITT population.|||participants|||Number
2712308|NCT01155778|Secondary|Change From Baseline in Quality of Life (QoL) Using Children's Sleep Habits Rating Scale at Week 22 and Week 26 (EOS)|Children's sleep habits rating scale consisting of 35 item parent questionnaire sleep screening tool. Items are scored on a 3-point scale from 1 (rarely) to 3 (usually) with a Total Sleep Disturbance score (TSDS) ranging from 35-105. Eight subscale scores are totaled to create the TSDS. The subscales are: Bedtime Resistance (BR)(6 items, score = 6-18), Sleep Duration (SD)(3 items, score = 3-9), Parasomnias (P)(7 items, score = 7-21), Sleep Disordered Breathing (SDB)(3 items, score = 3-9), Night Waking (NW)(3 items, score = 3-9), Daytime Sleepiness (DS)(8 items, score = 8-24), Sleep Anxiety (SA)(4 items, score = 4-12), and Sleep Onset Delay (SOD)(1 item, score = 1-3). The questionnaire was designed for children aged 4 through 12 years. A higher score is indicative of more disturbed sleep.|Baseline, Week 22, Week 26/EOS|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712309|NCT01155778|Secondary|Change From Baseline in Quality of Life (QoL) Using Child Health Questionnaire™ Child Form 87 (CHQ-CF87) at Week 26 (EOS)|CHQ-CF87 form was designed to be a self-report for participants 10 years and older. It consists of 87 questions and contains the same scales as the PF-50, (with the omission of the parental impact scales and there are no psychosocial and physical summary scores derived). As per statistical analysis plan, the outcome was to be assessed only if greater than (>) 50 percent (%) of participants were available for the evaluation.|Baseline, Week 26/EOS|This outcome measure was not analyzed as it does not meet the pre-specified SAP criteria (outcome was to be assessed only if greater than (>) 50 percent (%) of participants were available for the evaluation).||||||
2712310|NCT01155778|Secondary|Change From Baseline in Quality of Life (QoL) Using Infant Toddler Quality of Life Questionnaire™ (ITQOL) at Week 22 and Week 26 (EOS)|"ITQOL is a generic, validated health status measure for children aged 2 months up to 5 years, including items and scales to measure aspects of physical functioning, development, pain, mood, behavior, general health and impact on parents. The ITQOL consists of 97 items that are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). The score range for all individual subscales is 0 (worst health) to 100 (best health).~Abbreviation: Overall Health (OH), Physical Abilities (PA), Growth And Development (GAD), Bodily Pain (BP), Temperament And Moods (TAM), General Behavior (GEB), Global Behavior (GLB), Getting Along (GA), General Health Perceptions (GHP), PI-Emotion (PIE), PI-Time (PIT), Family Cohesion (FC)."|Baseline, Week 22, Week 26/EOS|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712311|NCT01155778|Secondary|Change From Baseline in Quality of Life (QoL) Using Child Health Questionnaire™ Parent Form 50 (CHQ-PF50) Questions at Week 22 and Week 26 (EOS)|CHQ-PF50 which was designed to measure the physical and psychosocial well-being of children 5 years to 18 years of age, consists of 13 health concepts including 11 multi-item and 2 single item scales: Physical Function (PF), Role/Social-Emotional/Behavioral (REB), Role/Social-Physical (RP), bodily pain (BP), General Behavior (BE), Mental Health (MH), Self Esteem (SE), General Health Perceptions (GH), Change in Health (CH), Parental Impact-Emotional (PE), Parental Impact-Time (PT), Family Activities (FA), and Family Cohesion (FC). Transformed scores for all subscales range from 0 to 100, with a higher score indicating better health. Physical and Psychosocial Summary measures (SM) were scored with the use of norm-based methods that standardize the scores to a mean (± Standard Deviation) of 50 ± 10 on the basis of an assessment of the general United States population. Higher values represent better health.|Baseline, Week 22, Week 26/EOS|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712361|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712312|NCT01155778|Secondary|Change From Baseline in Movement Assessment Battery for Children Second Edition (MABC-2) at Week 26 (EOS)|Movement Assessment Battery for Children, Second Edition (MABC-II) was to be used to identify, describe and guide the treatment of motor impairment in children from 3.0 to 16:11 years of age. As per statistical analysis plan, the outcome was to be assessed only if greater than (>) 50 percent (%) of participants were available for the evaluation.|Baseline, Week 26/EOS|This outcome measure was not analyzed as it does not meet the pre-specified SAP criteria (outcome was to be assessed only if greater than (>) 50 percent (%) of participants were available for the evaluation).||||||
2712313|NCT01155778|Secondary|Change From Baseline in Developmental Quotient (DQ) Using Vineland Adaptive Behavioral Scales Second Edition (VABS-II) at Week 22|VABS-II measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in participants. This test measures 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other four domains). Scoring is 'Usually' = 2, 'Sometimes'/Partially' = 1 or 'Never' = 0. The raw scores will be converted to domain standard scores (mean 100, SD 15). Higher scores indicate undesirable behavior. The Overall DQ score was calculated from the mean age-equivalent score obtained by averaging out the age equivalent scores for all the sub-domains except for Gross and Fine motor skills.|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712314|NCT01155778|Secondary|Change From Baseline in Sanfilippo Behavioral Rating Scale (SBRS) at Week 22 and Week 26 (EOS)|SBRS a parent-scored behavioral inventory measuring: comprehensive language skills, expressive language skills, tantrums, mood and emotions, and other behaviors not otherwise classified. Subscale items are scored 0=Never, 1=Occasionally(5-10%), 2=Sometimes (25%), 3=About half the time, 4=Often(75%), 5=Almost always (90%), 6=Always. Summary scores are the sum of responses within a given domain. Higher values = undesirable behavior. Total score range listed below with the abbreviations. Current Communication (CC)(0-42), Past Communication (PC)(0-42), Orality (0-36), Body Movements (BM)(0-30), Interaction With Objects (IWO)(0-24), Activity And Routines (AAR)(0-36), Emotional Function (EF)(0-18), Safety-consciousness (SC)(0-18), Fearfulness (0-36), Social Interaction (SI)(0-36), Eye Contact (EC)(0-18), Emotional Engagement (EE)(0-18), Comfort Seeking (CS)(0-30), Attention (0-18), Self-control/Compliance (SCC)(0-18), Mood, Anger/Aggression (MAA)(0-42), Self-gratification (SG)(0-24).|Baseline, Week 22, Week 26/EOS|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712315|NCT01155778|Secondary|Change From Baseline in Four Point Scoring System/Total Disability Score (FPSS/TDS) at Week 22 and Week 26 (EOS)|FPSS is a sanfilippo-specific disability assessment which assesses motor function, expressive/speech language, and cognitive function on a 0 to 3 point scale. A score of 3 points is assigned for normal function, 2 points for beginning of regression, 1 point for severe level of regression, and 0 points for lost skills. The total disability score (TDS) is the average (0-3) of the motor skills (MS), speech abilities (SA), and cognitive function (CF) scores. Lower scores indicate developmental regression.|Baseline, Week 22, Week 26|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712316|NCT01155778|Secondary|Change From Baseline in Developmental Quotient (DQ) Using Bayley Scales of Infant Development Third Edition (BSID III) and Kaufman Assessment Battery for Children Second Edition (KABC II) at Week 22|BSID-III was used to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers. This measure consists of a series of developmental play tasks. Raw scores of successfully completed items are converted to scale scores and to composite scores. The mean composite score is 100 and the standard deviation (SD) is 15.Higher scores are indicative of decreased development. KABC-II was an individually administered measure of the processing and reasoning abilities of children and adolescents between the ages of 3 and 18 years and is an alternative to BSID-III. BSID-III DQ score was based on the Cognitive domain. The DQ score was calculated from the data obtained from either BSID-III/KABC-II mental age equivalent of the child in months divided by the calendar age in months (multiplied by 100 to give percentage points).|Baseline, Week 22|ITT population. Here, n = participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2712317|NCT01155778|Primary|Number of Participants With Intrathecal Drug Device (IDDD) Failures at Week 26|Participants with IDDD failures were reported.|Week 26|ITT population.|||participants|||Number
2712318|NCT01155778|Primary|Summary of Anti-rhHNS Antibody Status in Serum by Recombinant Human Heparan N-Sulfatase (rhHNS) Dose Group|Participants with positive, negative and missing status were reported.|Baseline, Week 26|ITT population|||participants|||Number
2712319|NCT01155778|Primary|Summary of Anti-rhHNS Antibody Status in Cerebrospinal Fluid (CSF) by Recombinant Human Heparan N-Sulfatase (rhHNS) Dose Group|Participants with positive, negative and missing status were reported.|Baseline, Week 26|Intent to treat (ITT) population was defined as all enrolled participants who received at least 1 dose (full or partial) of study drug.|||participants|||Number
2712320|NCT01155778|Primary|Number of Treatment Emergent Adverse Events (TEAE)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs) were defined as all adverse events (AEs) from the time of the surgery for IDDD implantation to the last follow up contact, 30 (±7) days after the end of study (EOS) procedures.|Baseline to week 30 (follow-up)|Safety population.|||events|||Number
2712362|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712321|NCT01155778|Primary|Number of Treatment Emergent Serious Adverse Events (SAE)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs) were defined as all adverse events (AEs) from the time of the surgery for IDDD implantation to the last follow up contact, 30 (±7) days after the end of study (EOS) procedures.|Baseline to week 30 (follow-up)|Safety population was defined as all enrolled participants who received at least 1 dose (full or partial) of study drug.|||events|||Number
2712322|NCT01155726|Primary|Average Subjective Comfort|"Participants were asked, How would you rate your comfort with your study lenses? and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together."|Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3|Per protocol|||Units on a scale||Standard Deviation|Mean
2712323|NCT01155661|Secondary|Change From Baseline to Week 54 Endpoint in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline pulse rate value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2712324|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline blood pressure value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
2712325|NCT01155661|Secondary|The Number of Participants Experiencing Clinically Significant Effects as a Function of CYP2D6 Predicted Phenotype at Week 54 Endpoint|A clinically significant effect was defined as a treatment-emergent adverse event; a reported adverse event that first occurred or worsened during the treatment phase. CYP2D6 predicted phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The number of participants who reported at least one treatment-emergent adverse event is presented for each phenotype classification.|Baseline, Week 54|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||participants|||Number
2712326|NCT01155661|Secondary|Plasma Concentration of LY2216684||Weeks 2, 6, and 8|All enrolled participants with at least one plasma sample.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2712327|NCT01155661|Secondary|Percentage of Participants Who Meet Remission Criteria of Depressive Symptoms by Week 8|Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of <= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first remission was calculated. In the calculation, participants who did not meet remission criteria were considered as right-censored observations. The estimated percentage of participants who meet remission criteria by Week 8 from the Kaplan-Meier method is presented.|Baseline, Week 8|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||percentage of participants|||Number
2712328|NCT01155661|Secondary|Percentage of Participants With Discontinuation-Emergent Adverse Events (DEAEs)|Discontinuation-emergent adverse events (DEAEs) were events that first occurred or worsened within 1-week after abrupt discontinuation of LY2216684 (edivoxetine) treatment.|Up to1 week after discontinuation of treatment|All enrolled participants who abruptly discontinued LY2216684 (edivoxetine) treatment either at the end of the study or after early withdrawal from the study and who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||percentage of participants|||Number
2712329|NCT01155661|Secondary|Percentage of Participants Who Reported Resource Utilization (RU) at Baseline and at the Week 54 Endpoint|The Resource Utilization (RU) form assesses the frequency and type of medical services (a primary care visit and/or a psychiatrist visit) that participants used within the previous year (for the baseline visit) or within approximately the previous 3 months (for post-baseline visits or the Week 54 endpoint). The percentage of participants who reported greater than zero number of primary care doctor visits and greater than zero number of psychiatrist visits is presented.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Resource Utilization value.|||percentage of participants|||Number
2712330|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) percent of maximum possible score value.|||units on a scale||Standard Error|Least Squares Mean
2712474|NCT01154673|Primary|Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.|The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.|Baseline to Week 48||||HIV DNA copies/ million CD4 cells||Full Range|Median
2712331|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline EuroQol Questionnaire - 5 Dimension (EQ-5D) visual analog scale value.|||units on a scale||Standard Error|Least Squares Mean
2712332|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The Sheehan Disability Scale (SDS) Global Functional Impairment Score (total score) and Subscores were completed by the participant and were used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment [imp] score), social life (social life/leisure activities impairment [imp] score), and family life (family life/home responsibilities impairment [imp] score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Sheehan Disability Scale (SDS) subscale score.|||units on a scale||Standard Error|Least Squares Mean
2712333|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) anxiety subscale value.|||units on a scale||Standard Error|Least Squares Mean
2712334|NCT01155661|Secondary|Percentage of Participants Who Meet Response Criteria of Depressive Symptoms by Week 8|Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first response was calculated. In the calculation, participants who did not meet response criteria were considered as right-censored observations. The estimated percentage of participants who met response criteria by Week 8 from the Kaplan-Meier method is presented.|Baseline, Week 8|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||percentage of participants|||Number
2712335|NCT01155661|Secondary|Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint|Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of <= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of remission at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||Probability of remission|||Number
2712336|NCT01155661|Secondary|Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint|Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of response at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||Probability of response|||Number
2712337|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores|"The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The Experience Score was derived by taking the mean of Items 1 through 6, the Impact Score was derived by taking the mean of Items 7 through 13 (applicable items only), and the Average Score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit."|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Fatigue Associated with Depression (FAsD) average score and subscale score.|||units on a scale||Standard Error|Least Squares Mean
2712338|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S)|Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Clinical Global Impression - Severity (CGI-S) value.|||units on a scale||Standard Error|Least Squares Mean
2712339|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscales. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) depression subscale value.|||units on a scale||Standard Error|Least Squares Mean
2712340|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline MADRS individual item and total score value.|||units on a scale||Standard Error|Least Squares Mean
2712341|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline CPFQ total score value.|||units on a scale||Standard Error|Least Squares Mean
2712342|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale|The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline ASEX total score value.|||units on a scale||Standard Error|Least Squares Mean
2712343|NCT01155661|Secondary|Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Baseline through Week 54|All enrolled participants with a baseline and at least one post-baseline C-SSRS value.|||percentage of participants|||Number
2712344|NCT01155661|Primary|The Number of Participants Experiencing Clinically Significant Effects|"A clinically significant effect was defined as a serious adverse event, regardless of causality.~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Baseline through 54 weeks|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||participants|||Number
2712345|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712346|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712347|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712348|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712349|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712350|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712351|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 24|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712352|NCT01155570|Secondary|Physician's Overall Response Rating At Week 24|"Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as markedly improved, improved, not changed, or not assessable, comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions."|Baseline and Week 24|Participants in the Efficacy Analysis Population with assessment at Week 24.|||participants|||Number
2712353|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 16|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712354|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 4|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712355|NCT01155570|Primary|Dermatology Life Quality Index at Week 24|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712356|NCT01155570|Primary|Dermatology Life Quality Index at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712357|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
2712358|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
2712359|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
2712360|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
2712475|NCT01154634|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.|Pre-entry to follow-up||||Participants|||Number
2712363|NCT01155570|Primary|Physician's Global Assessment at Week 24|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712364|NCT01155570|Primary|Physician's Global Assessment at Week 16|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712365|NCT01155570|Primary|Physician's Global Assessment At Week 8|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 8|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712366|NCT01155570|Primary|Physician's Global Assessment at Week 4|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 4|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
2712367|NCT01155570|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs|"This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than not related (ie, probable, possible, or unclear). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events."|From study registration through Week 24|Safety Analysis Population|||participants|||Number
2712368|NCT01155531|Primary|Safety of Sertraline and Telenzepine Combination|safety of the drug combination was measured in terms of number of adverse events during the study period.|7 days||||number of adverse events|||Number
2712369|NCT01155531|Primary|Changes in the Meal Calories Consumed|The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.|The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.||||calorie||Standard Deviation|Mean
2712370|NCT01155531|Primary|Changes in the VAS Score From Baseline.|"The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject's room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: How hungry are you now? The anchor points of the 100mm scale were I am not hungry at all and Never more hungry corresponding to 0 mm and 100 mm respectively. The subjects' VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group."|The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal||||mm||Standard Deviation|Mean
2712371|NCT01155518|Primary|Insulin Resistance|To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.|6 months|study terminated||||||
2712372|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 2|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated (APaT): All participants who received at least one dose of study treatment.|||Participants|||Number
2712373|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated: All participants who received at least one dose of study treatment.|||Participants|||Number
2712374|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 1|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.|||Participants|||Number
2712375|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.|||Participants|||Number
2712376|NCT01155479|Secondary|Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.|||Score on a Scale||Standard Error|Mean
2712377|NCT01155479|Secondary|Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)|UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.|||Percentage of Responders||95% Confidence Interval|Number
2712378|NCT01155479|Primary|Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.|||Score on a Scale||Standard Error|Mean
2712379|NCT01155466|Secondary|"Change From Baseline at Week 12 in Mean On Time Without Troublesome Dyskinesia"|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.|||Hours/day||Standard Error|Mean
2712407|NCT01155193|Secondary|Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16|In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge.|During RSV season (September to June) from 2008 to 2016|Participants in registries 08/09 and 09/10 – 15/16 who were hospitalized, and hospitalization was documented on forms and with available diagnosis data (for registry 09/10 – 15/16)|||hospitalizations|hospitalizations||Count of Units
2712380|NCT01155466|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit."|Baseline and Week 12|The number of randomized and treated participants with a Week 12 value.|||Percentage of participants|||Number
2712381|NCT01155466|Primary|Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.|Baseline and Week 12|The number of participants who received at least one dose of study drug and had baseline and Week 12 data|||Scores on a scale||Standard Deviation|Mean
2712382|NCT01155466|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|The number of participants who received at least one dose of study drug|||Percentage of participants|||Number
2712383|NCT01155466|Primary|Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
2712384|NCT01155466|Primary|Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
2712385|NCT01155466|Primary|Number of Participants With Diastolic Blood Pressure >=105 mm Hg|The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
2712386|NCT01155466|Primary|Numberof Participants With Systolic Blood Pressure >=180 mm Hg|The number of participants with Systolic Blood Pressure >=180 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
2712387|NCT01155466|Primary|"Change From Baseline in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.|||Hours/day||Standard Error|Mean
2712388|NCT01155388|Secondary|Pharmacokinetics: Area Under The Curve Of Ferumoxytol|Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose|The PK population included all randomized participants who received at least 1 dose of study drug and consented to PK sampling. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2712389|NCT01155388|Primary|Mean Change In Hemoglobin From Baseline To Week 5|Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the sponsor to discontinue the combined AMAG FER-CKD-252 and AMAG FER-CKD-251 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5|Intent-to-Treat Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2712404|NCT01155193|Secondary|Parental Cooperation for Registry 08/09 and 09/10 - 15/16|"Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad:~Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents."|During RSV season (September to June) from 2008 to 2016|Evaluable population in in registries 08/09 and 09/10 - 15/16; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.|||Palivizumab injections|Palivizumab injections||Count of Units
2712390|NCT01155375|Secondary|Pharmacokinetics: Area Under The Curve Of Ferumoxytol|Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose|The PK population included all randomized participants who received at least 1 dose of study drug and consented to PK sampling. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2712391|NCT01155375|Primary|Mean Change In Hemoglobin From Baseline To Week 5|Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5|Intent-to-Treat Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
2712392|NCT01155336|Secondary|Cardiac Electrophysiology|A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.|1 week|Data was not collected for this outcome measure.||||||
2712393|NCT01155336|Primary|Platelet Function|Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.|12 hours|We did not complete the study and no subjects were randomized to corn oil|||seconds||Full Range|Mean
2712394|NCT01155323|Primary|Limbal Hyperemia|This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.|after 1 week of wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
2712395|NCT01155323|Primary|Subjective Rating of Quality Perceptions|This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
2712396|NCT01155323|Primary|Corneal Staining|Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
2712397|NCT01155323|Primary|Subjective Rating of Handling|This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
2712398|NCT01155323|Primary|Vision Quality|This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
2712399|NCT01155323|Primary|Subjective Rating of Comfort|This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
2712400|NCT01155284|Secondary|2 Hour C-peptide AUC in Response to MMTT|Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.|Month 6|Of the 70 subjects randomized, 58 completed treatment and analysis.|||pmol/L||95% Confidence Interval|Median
2712401|NCT01155284|Primary|2 Hour C-peptide AUC in Response to MMTT|Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.|Month 12|Of the 70 subjects randomized, 58 completed treatment and analysis.|||pmol/L||95% Confidence Interval|Median
2712402|NCT01155219|Primary|Ocular Tolerance|Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.|Day 84|Full Analysis Set|||participants|||Number
2712403|NCT01155193|Secondary|Mean Number of Palivizumab Injections|The mean number of palivizumab injections per participant, per season.|During RSV season (September to June) from 2002 to 2016|Evaluable population; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.|||palivizumab injections||Standard Deviation|Mean
2712405|NCT01155193|Secondary|Parental Cooperation in Registries 02/03 - 06/07 and 07/08|Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.|During RSV season (September to June) from 2002 to 2008|Evaluable population in registries 02/03 - 06/07 and 07/08|||Participants|||Count of Participants
2712406|NCT01155193|Secondary|Presence of Complications During Hospitalization||During RSV season (September to June) from 2002 to 2016|Evaluable population who were hospitalized and with available hospitalization complication data|||hospitalizations|hospitalizations||Count of Units
2712408|NCT01155193|Secondary|Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08|Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.|During RSV season (September to June) from 2002 to 2008|Participants in registries 02/03 - 06/07 and 07/08 who were hospitalized, and hospitalization was documented on paper case report forms.|||hospitalizations|hospitalizations||Count of Units
2712409|NCT01155193|Primary|Percentage of Participants With RSV-associated Hospitalization||During RSV season (September to June) from 2002 to 2016|Evaluable population with available hospitalization data|||percentage of participants|||Number
2712410|NCT01155180|Primary|Percent Change From Baseline in Body Weight at 6 Months|Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.|baseline and 6 months after randomization||||percentage change||Standard Error|Mean
2712411|NCT01155167|Secondary|Radial Artery Patency|Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).|24 hours|per protocol|||participants|||Number
2712412|NCT01155167|Secondary|Radial Artery Spasm During Catheterization|The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.|2 hours|All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded|||participants|||Number
2712413|NCT01155167|Primary|Change in Radial Artery Diameter|The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.|Baseline and after 30 minutes of drug application||||Percent change||Standard Deviation|Mean
2712414|NCT01155154|Primary|Number of Participants With Presence of Wound Infection|Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.|2 weeks||||participants|||Number
2712415|NCT01155141|Secondary|Total Cholesterol||Baseline - Month 6||||mg/dL||Standard Deviation|Median
2712416|NCT01155141|Secondary|Glucose||Baseline - Month 6||||mg/dL||Standard Deviation|Median
2712417|NCT01155141|Secondary|Diastolic Blood Pressure||Baseline - Month 6||||mm Hg||Standard Deviation|Median
2712418|NCT01155141|Secondary|Systolic Blood Pressure||Baseline - Month 6||||mm Hg||Standard Deviation|Median
2712419|NCT01155141|Secondary|Weight||Baseline - Month 6||||kg||Standard Deviation|Median
2712420|NCT01155141|Primary|Protein/Creatinine Ratio||Baseline - Month 6||||unitless||Standard Deviation|Median
2712421|NCT01155141|Secondary|eGFR||Baseline - Month 6||||mL/min/1.73m^2||Standard Deviation|Median
2712422|NCT01155141|Primary|Serum Creatinine||Baseline - Month 6||||mg/dL||Standard Deviation|Median
2712423|NCT01155141|Primary|24 Hour Proteinuria||Baseline - Month 6||||g/day||Standard Deviation|Median
2712424|NCT01155063|Secondary|Percentage of Participants With Recurrent Disease|Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).|Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2712425|NCT01155063|Secondary|Time to Discontinuation of Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2712426|NCT01155063|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2712427|NCT01155063|Secondary|Percentage of Participants Who Discontinued the Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
2712428|NCT01155063|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||Participants|||Number
2712429|NCT01155063|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||Participants|||Number
2712430|NCT01155063|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||Participants|||Number
2712431|NCT01155024|Secondary|Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket|Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket|3 months|Total number of participants completing the period (3 months usage of direct manufactured socket) and participants classified as 'Withdrawal by participant'. Analysis does not include participants who prematurely withdrew for reasons unrelated to the direct manufactured socket intervention.|||participants|||Number
2712432|NCT01155024|Secondary|Participant Socket Preference After Initial Fitting|Number of participants indicating socket preference after initial fitting of both socket interventions|Within the first 4-6 hours|Total number of participants completing period for both study interventions.|||participants|||Number
2712437|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups"|6 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment|||U/L||Standard Deviation|Mean
2712438|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups"|3 month endpoint|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment|||U/L||Standard Error|Least Squares Mean
2712439|NCT01154985|Primary|Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies|"Patient is considered a responder if histological examination shows:~Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis~A priori threshold for statistical significance is p<0.05, 1-sided"|12 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment|||participants|||Number
2712440|NCT01154816|Secondary|Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.|Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter.|day 7 of protocol therapy|Of all eligible patients enrolled, 31 provided a seventh day of administration prior to the administration of the day 7 dose sample for analysis.|||ng/ml||Standard Deviation|Mean
2712441|NCT01154816|Secondary|Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose|Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter.|day 4 of protocol therapy|Of all eligible patients enrolled, 30 provided a fourth day of administration prior to the administration of the day 4 dose sample for analysis.|||ng/ml||Standard Deviation|Mean
2712442|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration|Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration six hours after administration sample for analysis.|||ng/ml||Standard Deviation|Mean
2712443|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration|Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration three hours after administration sample for analysis.|||ng/ml||Standard Deviation|Mean
2712444|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration|Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration one hour after administration infusion sample for analysis.|||ng/ml||Standard Deviation|Mean
2712445|NCT01154816|Secondary|Serum Concentration of Alisertib Prior to the First Day of Administration|Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 32 provided a prior to the first day of administration sample for analysis.|||ng/ml||Standard Deviation|Mean
2712446|NCT01154816|Secondary|Number of Patients Cycles With Grade 3 or Higher Adverse Event|The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.|Up to 24 months|116 patients contributed 360 patient-cycles to the analysis.|||Patient-cycle|||Number
2712447|NCT01154816|Primary|Number of Participants With Overall Response|For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with < 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.|From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.|Of the 118 enrolled patients, two were not evaluable for the primary outcome measure. Neither received protocol therapy. One was enrolled in arm 11, one was enrolled in Arm 1.|||Patients|||Number
2712448|NCT01154751|Secondary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|2 Years|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
2712449|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|2 Years|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
2712450|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|1 Year|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
2712451|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|6 months|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
2712452|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|30 days|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
2712453|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|At baseline|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
2712454|NCT01154751|Secondary|Stent Fracture|"Stent fracture and Involuntary stent migration are types of device System Failure.~Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct."|1 to 3 Years|The number of patients analyzed is based on the data available.|||participants|||Number
2712455|NCT01154751|Secondary|Stent Fracture|"Stent fracture and Involuntary stent migration are types of device System Failure.~Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct."|1 to 2 years|The number of patients analyzed is based on the data available.|||participants|||Number
2712456|NCT01154751|Secondary|Stent Fracture|Stent fractures determined by fluoroscopy .|1 Year|The number of patients analyzed is based on the data available.|||participants|||Number
2712457|NCT01154751|Secondary|Target Lesion Revascularization|"Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.~Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)"|1 Year|The number of patients analyzed is based on the data available.|||percentage of participants|||Number
2712458|NCT01154751|Secondary|Target Lesion Revascularization|Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|6 months|The number of patients analyzed is based on the data available.|||percentage of participants|||Number
2712459|NCT01154751|Secondary|Restenosis by Duplex Ultrasound|In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.|1 Year|"If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.~The number of patients analyzed is based on the data available."|||percentage of participants|||Number
2712476|NCT01154634|Secondary|Terminal Half-life (T Half)|Terminal half-life (T half)|0 to 12 hours post dose|"Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.~Two samples were not analyzed for T half due to technical reasons."|||hours||95% Confidence Interval|Geometric Mean
2712460|NCT01154751|Secondary|Restenosis by Duplex Ultrasound|In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.|6 months|"If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.~The number of patients analyzed is based on the data available."|||percentage of participants|||Number
2712461|NCT01154751|Secondary|Rutherford-Becker Clinical Category|"Rutherford/Becker Categories:~0 - Asymptomatic, no hemodynamically significant occlusive disease.~- Mild claudication.~- Moderate claudication.~- Severe claudication.~- Ischemic rest pain.~- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.~- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|30 days|The number of patients analyzed is based on the data available.|||percentage of participants|||Number
2712462|NCT01154751|Secondary|Number of Peri-procedural and Post-procedural Complications|Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.|30 days||||Number of compilcations|||Number
2712463|NCT01154751|Secondary|Number of Participants Experiencing Peri-procedural and Post-procedural Complications|Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.|30 days||||Participants|||Count of Participants
2712464|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|1 Year|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
2712465|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|6 months|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
2712466|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|30 days|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
2712467|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|At baseline|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
2712468|NCT01154699|Secondary|FEV1 %Predicted|Performed as part of spirometry|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.|||percentage of predicted FEV1||Standard Deviation|Mean
2712469|NCT01154699|Secondary|Short Form (SF-36) Health Survey|Well validated quality of life questionnaire that measures eight sub-sections, which are summed to yield a score from 0 (maximal disability) to 100 (no disability). The eight subsections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of the study|||units on a scale||Standard Deviation|Mean
2712470|NCT01154699|Secondary|Pittsburgh Sleep Quality Index (PSQI)|Well validated questionnaire used frequently to measure sleep quality over the prior 1 month. It consists of 19 individual items that combine to form 7 components summed to create one global score. The overall score is between 0 (better sleep) and 21 (worse sleep).|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.|||units on a scale||Standard Deviation|Mean
2712471|NCT01154699|Secondary|Epworth Sleepiness Scale (ESS)|8 item questionnaire to measure daytime sleepiness, with total score reported 0 (less sleepy) to 24 (most sleepy). Scores greater than or equal to 10 are considered excessive daytime sleepiness.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.|||units on a scale||Standard Deviation|Mean
2712472|NCT01154699|Primary|Airway Reactivity as Measured by Methacholine Challenge (PC20)|This is a physiological measurement derived from repeated breathing maneuvers which measures airway reactivity. Subjects are exposed to higher and higher concentrations of an airway irritant (in this case methacholine), and between each dose perform spirometry. The test is stopped after the forced expiratory volume in 1 second (FEV1) falls 20% below the baseline. The concentration of methacholine at which this occurs is called the PC20. Methacholine challenges are routinely used in the diagnosis of asthma, and in many asthma research studies to measure changes in airway reactivity.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed the crossover study design|||mg/mL||Standard Error|Geometric Mean
2712473|NCT01154699|Primary|Asthma Control Test|Well validated questionnaire of asthma symptoms which includes 5 written questions. Each question is answered on a scale of 1-5, which are summed to report a range of asthma control from 5 to 25 (higher score indicates better asthma control).|Every 4 weeks during the 12 week study (at the start and end of the Usual Care period, and at the start and end of the Bilevel PAP intervention period)|All 21 patients went through usual care and bilevel PAP therapy|||units on a scale||Standard Deviation|Mean
2712477|NCT01154634|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration (Tmax)|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||hours||Full Range|Median
2712480|NCT01154634|Secondary|Area Under the Plasma Concentration Curve(AUC)|Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||nmol*h/L||95% Confidence Interval|Geometric Mean
2712481|NCT01154634|Secondary|Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal|Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.|0 to 3 hours post meal|Data from two subjects were excluded from efficacy analysis due to incorrect medication received Data from five visits from two subject were excluded form analysis due to deviations caused by technical problems.|||relaxations||Full Range|Geometric Mean
2712482|NCT01154634|Primary|Reflux Episodes 0 to 3 Hours Post Meal|Total number of reflux episodes 0 to 3 hours post meal|0 to 3 hours post meal|Data from two subjects (one in arm AZD2516 5 mg, and one in arm Placebo) were excluded from efficacy analysis due to incorrect medication received.|||Episodes||Full Range|Geometric Mean
2712483|NCT01154452|Secondary|Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 4 months||||participants|||Number
2712484|NCT01154452|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in patients with advanced sarcoma. (Phase II)|6 weeks||||percentage of participants|||Number
2712485|NCT01154452|Primary|Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)||Up to 28 days||||mg|||Number
2712486|NCT01154335|Secondary|Response Rate|Response rate (RR) will be estimated as the proportion of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Only patients who received at least 8 weeks of treatment were considered evaluable for response and were included in the response rate analysis|||participants|||Number
2712487|NCT01154335|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time between Day 1 Cycle 1 to the date of death from any cause. Those remaining alive will be censored at their last known assessment or follow-up.|18 months||||weeks||95% Confidence Interval|Median
2712488|NCT01154335|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time between Day 1 Cycle 1 and date of first documented recurrence or death. Patients who do not exhibit progression while on trial will be censored at their last known assessment. Progression is defined per RECIST criteria as either 1) at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum. OR 2) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|18 Months||||weeks||95% Confidence Interval|Median
2712489|NCT01154335|Primary|To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.||18 Months||||milligrams|||Number
2712490|NCT01154322|Primary|Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|AHI after min 21 days use with Pixi mask||||AHI (events/hour)||Standard Deviation|Mean
2712491|NCT01154322|Primary|Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|Baseline AHI|Subjects who completed all visits and procedures|||AHI (events/hour)||Standard Deviation|Mean
2712492|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts With Substance Use|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.|6 months post randomization||||sex acts with substance use|||Number
2712493|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Partners|Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.|6 months post randomization||||unprotected partners||Standard Error|Least Squares Mean
2712494|NCT01154296|Secondary|Sexual Risk Behavior -- # of Partners|Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.|6 months post randomization||||partners||Standard Error|Least Squares Mean
2712495|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Sex Acts|Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts|6 months post randomization||||unprotected sex acts||Standard Error|Least Squares Mean
2712496|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.|6 months post randomization||||sex acts||Standard Error|Least Squares Mean
2712497|NCT01154296|Primary|STI Incidence|Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.|6 months post randomization||||participants|||Number
2712498|NCT01154283|Secondary|EuroQol Visual Analogue Scale(VAS)|Quality of life assessed with visual analogue scale. Where the patient is asked to place a mark on a piece of paper with a vertical, scale from 100 at the top to 0 at the bottom of the scale. Where the patient is informed that 100 represents his or her best imaginable health state and 0 is his or her worst imaginable health state.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report quality of life at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete quality of life assessments.|||units on a scale||Standard Deviation|Mean
2712499|NCT01154283|Secondary|Transitional Dyspnea Index|Transitional Dyspnea Index scores patient reported changes in difficulty breathing during each intervention period from -3 (major deterioration) to +3 (major improvement) in three categories: functional impairment, magnitude of task, and magnitude of effort. The total TDI score ranges from -9 to +9.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report dyspnea at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete dyspnea assessments.|||units on a scale||Standard Deviation|Mean
2712500|NCT01154283|Secondary|"Patient Preference (Likert Scale) Definitely IPAP-only Probably IPAP-only Uncertain Probably Bi-level Definitely Bi-level"|"Patient Preference of NIPPV mode:~definitely IPAP-only probably IPAP-only uncertain probably Bi-level definitely Bi-level Number of patients who chose definitely or probably are reported."|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died before completion of 12 weeks (second intervention) and could not have patient preference assessed.|||participants|||Number
2712501|NCT01154283|Primary|Hours of NIPPV Usage|Patients experienced the first intervention period during weeks 1-6 and the second intervention period during weeks 7-12. Patients were given one week to learn how to use the NIPPV equipment at the beginning of each intervention period. Therefore, only the total NIPPV hours used during the last 5 weeks of each intervention period were collected and divided by the number of weeks to obtain the average, weekly hours of NIPPV usage assessed at 6 weeks (first intervention) and 12 weeks (second intervention) for each patient.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)||||hours||Full Range|Mean
2712502|NCT01154231|Secondary|Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes|Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.|||percentage|evaluations by physicians|95% Confidence Interval|Number
2712503|NCT01154231|Primary|Number of Administrations Required for Hemostasis for Bleeding Events|Mean number of administrations for hemostasis in replacement therapy for bleeding events.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.|||administrations|dosing for hemostasis|Full Range|Mean
2712504|NCT01154231|Primary|Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy|Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.|||Bleeding events/year||Inter-Quartile Range|Median
2712505|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2712506|NCT01154218|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2712507|NCT01154218|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N = 35' is signifying those participants who were evaluable for this measure at the specified time point for crizotinib CIC fed arm group.|||ng*hr/mL||Standard Deviation|Geometric Mean
2712508|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2712509|NCT01154218|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
2712630|NCT01153984|Secondary|Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1|CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline.|Baseline up to approximately 4 years|All enrolled participants.|||percentage of participants|||Number
2712510|NCT01154218|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2712511|NCT01154218|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2712512|NCT01154218|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2712513|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2712514|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2712515|NCT01154218|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2712516|NCT01154192|Secondary|DHEA|Assess serum levels of DHEA after stimulation with recombinant hCG|24 hours|Oligomenrrhea group not included in study|||ng/ml||Standard Error|Mean
2712517|NCT01154192|Secondary|Androstenedione|Assess serum levels of androstenedione after stimaultion with recombinant hCG|24 hours|Oligomenorreha group not inlcuded in study|||ng/ml||Standard Error|Mean
2712518|NCT01154192|Secondary|Testosterone|Assess seruim levels of testosterone after stimulation with recombinant hCG|24 hours|Oligpmenrreha group not included in study|||ng/ml||Standard Error|Mean
2712519|NCT01154192|Primary|17OHP Levels After hCG|Assess serum levels of 17OHP after stimulation with recombinant hCG|24 hours|Oligmenorhea group not included in study|||ng/ml||Standard Error|Mean
2712520|NCT01154166|Secondary|Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF|The mean number of days after which the dose of L-dopa was readministered after the reduction in dose was recorded.|Baseline to Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.|||days||Standard Deviation|Mean
2712521|NCT01154166|Secondary|Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF|"The PDQ39 is a 39 item self-administered questionnaire. The questionnaire covers eight domains of health that are reported as adversely affected by patients with PD. Participants were asked to rate responses on a scale from 0 to 4 (never to always). The overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem). Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points for the indicated domain were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
2712522|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF|The PDSS uses a series of 15 questions to assess sleep disturbance associated with PD. Participants completed the assessments based on their experiences in the past week by marking a cross on each 10 centimeter (cm) scale (labelled from worst to best state). Responses were quantified by measuring the distance along each line where the cross was placed. The scores for each item ranged from 0 (symptom severe and always experienced) to 10 (symptom free). The maximum cumulative score for the PDSS was thus 150 (free of all symptoms). Change from BL=value at Week 24 minus the BL value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
2712523|NCT01154166|Secondary|Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF|The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
2712524|NCT01154166|Secondary|Number of Responders to Study Treatment Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent off and at least a 20% reduction from Baseline in the L-dopa dose."|Baseline to Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||participants|||Number
2712525|NCT01154166|Secondary|Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF|In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias [neurological movement disorder]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose.|Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.|||participants|||Number
2712526|NCT01154166|Secondary|Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF|The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be responders.|Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||participants|||Number
2712527|NCT01154166|Secondary|Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF|The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
2712528|NCT01154166|Secondary|"Mean Change From Baseline in Total Awake Time on Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Participants were asked to record the number of awake hours spent on without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spentonwithout TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.|||hours||Standard Deviation|Mean
2712529|NCT01154166|Secondary|"Mean Change From Baseline in Total Awake Time Spent on at Week 24 Using LOCF"|"The on state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their on periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent on per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.|||hours||Standard Deviation|Mean
2712530|NCT01154166|Secondary|"Mean Change From Baseline in the Percentage of Awake Time Spent Off (ATSO) at Week 24 Using LOCF"|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their off periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent off per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent on) * 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.|||Percentage of time||Standard Deviation|Mean
2712531|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF|The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL.|Baseline and Week 24 (Visit 13)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
2712532|NCT01154166|Primary|"Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF)"|"The off state is defined as the state in which Parkinson's Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their off  periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent off per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24 (Visit 13)|Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points.|||hours||Standard Deviation|Mean
2712533|NCT01154153|Secondary|The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase|The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0.|From randomization to 43-50 days postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Percentage of days||Standard Deviation|Mean
2712728|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
2712534|NCT01154153|Secondary|Number of Participants Using Rescue Medication|The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study).|From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Participants|||Number
2712535|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Participant|Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Participants|||Number
2712536|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Physician|Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Participants|||Number
2712537|NCT01154153|Secondary|Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)|"Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).~Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase)."|From 8-24 days prerandomization up to 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Score on a scale||Standard Deviation|Mean
2712538|NCT01154153|Primary|Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline|"Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.~Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis."|1-3 days prerandomization and 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Ratio||Full Range|Geometric Mean
2712539|NCT01154140|Secondary|Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities|ALT/AST (Grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Alkaline Phosphatase (g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160-250,g3:>250-500,g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40,g3:<40-30,g4:<30mg/dL);hyperkalemia (g1:>ULN-5.5,g2:>5.5-6,g3:>6-7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3-2.5,g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3-8,g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7,g3:<7-6,g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5,g3:>12.5-13.5,g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7,g4:<0.7mg/dL);hyponatremia (g1:<LLN-130,g3:<130-120,g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2,g3:<2,g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL). Participant>=1 abnormality given.|Baseline up to follow up period (up to 72 months)|"Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure. Here, n=participants who were evaluable at specified time points."|||percentage of participants|||Number
2712553|NCT01154140|Secondary|Time to Extracranial Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
2712540|NCT01154140|Secondary|Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities|Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.|Baseline up to follow up period (up to 72 months)|Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2712541|NCT01154140|Secondary|Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization and date of discharge.|Baseline up to follow up period (up to 72 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percentage of participants|||Number
2712542|NCT01154140|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|"The patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment. Here, N signifies participants who were evaluable for this outcome measure."|||units on a scale||95% Confidence Interval|Mean
2712543|NCT01154140|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||units on a scale||95% Confidence Interval|Mean
2712544|NCT01154140|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||units on a scale||95% Confidence Interval|Mean
2712545|NCT01154140|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||units on a scale||95% Confidence Interval|Mean
2712554|NCT01154140|Secondary|Time to Intracranial Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
2712546|NCT01154140|Secondary|Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.|From randomization of treatment up to deterioration while on study treatment (up to 35 months)|The patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||months||95% Confidence Interval|Median
2712547|NCT01154140|Secondary|Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR|The Response Genetics, Inc. EML4 ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants with confirmed CR or PR according to RECIST v1.1 determined by IRR, by type of ALK gene fusion variant were reported in this outcome measure. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7). Here, n signifies participants who were evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
2712548|NCT01154140|Secondary|Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants|The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.|28 days prior to day 1 of study treatment|The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).|||percentage of participants|||Number
2712549|NCT01154140|Secondary|Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182|Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.|Predose at Day 1 of Cycle 2, 3 and 5|Pharmacokinetic concentration population included all participants in the safety analysis population who had at least 1 plasma concentration of crizotinib or its metabolite.N=participants evaluable for this measure.Number of participants analyzed(n)=participants evaluable at specified time points.This analysis was performed in crizotinib arm only.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2712550|NCT01154140|Secondary|Percentage of Participants With Adverse Events (AEs) According to Maximum Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.|Baseline up to follow up period (up to 72 months)|The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||percentage of participants|||Number
2712551|NCT01154140|Secondary|Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to follow up period (up to 72 months)|The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||percentage of participants|||Number
2712552|NCT01154140|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to follow up period (up to 72 months)|The safety analysis population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||percentage of participants|||Number
2712555|NCT01154140|Secondary|Time to Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
2712556|NCT01154140|Secondary|Percentage of Participants With Disease Control at Week 12 Based on IRR|Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.|Week 12|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percentage of participants||95% Confidence Interval|Number
2712557|NCT01154140|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.|Randomization to first documentation of objective tumor response (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here N signifies participants with objective tumor response and were evaluable for this outcome measure.|||weeks||Full Range|Median
2712558|NCT01154140|Secondary|Duration of Response (DR) Based on IRR|DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions, disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here Overall number of participants analyzed (N) signifies participants with objective tumor response and were evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2712559|NCT01154140|Secondary|Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR|ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percentage of participants||95% Confidence Interval|Number
2712560|NCT01154140|Secondary|Overall Survival Probability at Month 12 and 18|Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.|Month 12, 18|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percent probability||95% Confidence Interval|Number
2712561|NCT01154140|Secondary|Overall Survival (OS)|OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.|From randomization to death or last date known alive for those not known to have died (up to 72 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
2712729|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
2712562|NCT01154140|Primary|Progression-Free Survival (PFS) Based on IRR|PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date − randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
2712563|NCT01154127|Secondary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1|"SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise.~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 1|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||Seconds||95% Confidence Interval|Least Squares Mean
2712564|NCT01154127|Secondary|Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||units on a scale||95% Confidence Interval|Least Squares Mean
2712565|NCT01154127|Secondary|Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||units on a scale||95% Confidence Interval|Least Squares Mean
2712566|NCT01154127|Secondary|Specific Airways Conductance (SGaw)|"SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||litres/(Second*kpa); kpa = kilopascal||95% Confidence Interval|Least Squares Mean
2712567|NCT01154127|Secondary|Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)|"Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.~Total Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period)."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.|||Litres||95% Confidence Interval|Least Squares Mean
2712568|NCT01154127|Secondary|Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|"FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards.~FVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests.~The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||Litres||95% Confidence Interval|Least Squares Mean
2712569|NCT01154127|Secondary|Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|"IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest.~The analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.|||Litres||95% Confidence Interval|Least Squares Mean
2712730|NCT01153672|Secondary|Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to approximately 5 years||||percentage of participants|||Number
2712570|NCT01154127|Secondary|Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting primary the PD assessment.|||Liters||95% Confidence Interval|Least Squares Mean
2712571|NCT01154127|Primary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment|SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||seconds||95% Confidence Interval|Least Squares Mean
2712572|NCT01154101|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) as an Indicator of the Pharmacodynamic Effects of SRT2104|The pharmacodynamic effects of SRT2104 was measured by biomarkers of psoriatic disease activity and/or sirtuin pathway activation (hsCRP and FGF21) in blood samples. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Days 28, 56 and 84|EAS population. Only those participants available at the specified time points were analyzed.|||mg per Liter||Standard Deviation|Mean
2712573|NCT01154101|Secondary|Change From Baseline in Fibroblast Growth Factor 21 (FGF21) as an Indicator of the Pharmacodynamic Effects of SRT2104|The pharmacodynamic effects of SRT2104 was measured by biomarkers of psoriatic disease activity and/or sirtuin pathway activation (hsCRP and FGF21) in blood samples. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Days 28, 56 and 84|EAS population. Only those participants available at the specified time points were analyzed.|||Picogram per milliliter||Standard Deviation|Mean
2712574|NCT01154101|Secondary|Maximum Plasma Concentration (Cmax) of 12 Weeks of Dosing With 250 Milligrams (mg), 500 mg and 1000 mg SRT2104 in the Fed State in Participants|A total of five blood samples (6 mL each) were obtained from each participant at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12), for determination of SRT2104 plasma concentrations. No two samples were separated by less than an hour. One pre-dose sample was collected prior to taking study medication (30 minutes or less before dosing) at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12). A single pharmacokinetic (PK) sample was collected in the time interval of 0.5 to 2 hours post-dose and also 3 to 6 hours post-dose at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12). Two PK samples were collected in the time interval of 6 to 22 hours post dose at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12).|One sample: Pre-dose (30 minutes or less before dosing), One sample: 0.5 to 2 hours post-dose and 3 to 6 hours post-dose and 2 samples 6 to 22 hours post dose, at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12)|PK population.|||ng/mL||Standard Deviation|Mean
2712575|NCT01154101|Secondary|Area Under Curve (AUC) of 12 Weeks of Dosing With 0.25 g, 0.5 g and 1.0 g SRT2104 in the Fed State in Participants|A total of five blood samples (6 milliliter [mL] each) were obtained from each participant up to Week 12, for determination of SRT2104 plasma concentrations. No two samples were separated by less than an hour. One pre-dose sample was collected prior to taking study medication (30 minutes or less before dosing) at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12). A single pharmacokinetic (PK) sample was collected in the time interval of 0.5 to 2 hours post-dose and also 3 to 6 hours post-dose at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12). Two PK samples were collected in the time interval of 6 to 22 hours post dose at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12).|Pre-dose (30 minutes or less before dosing: 1 sample), 0.5 to 2 hours and 3 to 6 hours post-dose (1 sample), 6 to 22 hours post-dose (2 samples) up to Week 12|PK population which comprised of all participants who received at least one dose of SRT2104 for whom a PK sample was obtained and analyzed.|||Nanogram x hour/milliliter (ng*h/mL)||Standard Deviation|Mean
2712576|NCT01154101|Secondary|Summary of Physician's Global Assessment (PGA) Score After 4, 8 and 12 Weeks of Exposure|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. Participants in the SRT2104 0.25 g dose group inadvertently used an incorrect version of the PGA scale and thus do not have PGA data available. Participants in the SRT2104 0.25 g dose group inadvertently used an incorrect version of the PGA scale and thus do not have PGA data available.|Weeks 4, 8 and 12|EAS Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2712577|NCT01154101|Secondary|Number of Participants With Clinical Activity in Psoriasis Area and Severity Index (PASI) Score After 4, 8, and 12 Weeks of Exposure|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score).|Weeks 4, 8 and 12|Efficacy Analysis Set (EAS) population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2712578|NCT01154101|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital sign assessments included measurements of resting heart rate and blood pressure. Potential clinical concern range for systolic blood pressure: <85 and >160 millimeter of mercury (mmHg), for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.|Up to Follow-up (Day 114)|SAF Population.|||Participants|||Count of Participants
2712579|NCT01154101|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|12-lead ECG was performed in the rested state with the participant in the supine position with ECG leads on for at least 5 minutes prior to ECG recording. ECGs included PR (PQ), QRS, QT and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Identification of any conduction abnormalities were recorded in the eCRF. If a participant's QTc intervals were prolonged, then the ECG was done in triplicate with results reported as an average of the three ECGs. Number of participants with abnormal electrocardiogram (ECG) values are presented.|Up to Follow-up (Day 114)|SAF Population.|||Participants|||Count of Participants
2712580|NCT01154101|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|The potential clinical concern range for clinical chemistry parameters were: Albumin:(low: <0.86 gram/Liter x LLN), Calcium:(low: <0.91 millimol/Liter [mmol/L] x LLN and high: >1.06 mmol/L x ULN), Creatinine: (high: >1.3 mmol /L x ULN), Glucose: (low: <0.71 mmol/L x LLN, high: >1.41 mmol/L x ULN), Magnesium: (low: <0.63 mmol/L x LLN, high: >1.03 mmol/L x ULN), Phosphorus: (low: <0.8 mmol/L x LLN, high: >1.14 mmol/L x ULN), Sodium: (low: <0.96 mmol/L x LLN, high: >1.03 mmol/L x ULN), Urea: (high: >1.5 mmol/L x ULN), Gamma glutamyl transferase: (high: >2 International units per L x ULN), Total bilirubin (high: 1.5 x ULN), both alanine amino transferase and aspartate amino transferase (high:≥ 2x ULN Units/L) and Bicarbonate: (low: <18 mmol/L and high: >32 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to Follow-up (Day 114)|SAF Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2712581|NCT01154101|Primary|Number of Participants With Hematology and Coagulation Abnormalities of Potential Clinical Concern|Hematology parameters included hemoglobin, hematocrit, red blood cell count, red cell distribution width, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, white blood cell count and complete white blood cell count differential. Coagulation parameters included activated partial thromboplastin time and prothrombin time/international normalized ratio. The potential clinical concern range for hematology parameters were: white blood cell count (low: <0.67x10^9/Liter x lower limit of normal [LLN] and high: >1.82x10^9/L x upper limit of normal [ULN]), neutrophil count: (low: <0.83x10^9/Liter x LLN), hemoglobin (low: <0.85 gram/Liter x LLN and high: >1.03 gram/Liter x ULN for males and >1.13 gram/Liter x ULN for females), hematocrit with units ratio (high: >1.02 x ULN for males and >1.17 x ULN for females), platelet count (low: <0.67x10^9/Liter x LLN and high >1.57x10^9/Liter x ULN) and lymphocytes (low: <0.81x10^9/Liter x LLN).|Up to Follow-up (Day 114)|SAF Population.|||Participants|||Count of Participants
2712582|NCT01154101|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The AE category in the data table includes participants who experienced serious or non-serious adverse events or both.|Up to Follow-up (Day 114)|Safety Analysis Set (SAF) population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2712583|NCT01154101|Primary|Assessment of Clinical Activity by Improvement Score (Using Krueger Criteria): Number of Participants With Good or Excellent Improvement Score Based on Histological Assessments of Skin Biopsies After 12 Weeks of Exposure|"According to the Krueger criteria, improvement score is classified as Good improvement defined as reduction in epidermal thickness by at least 30% normalized keratinocyte differentiation but most keratinocytes still express K16. Excellent improvement defined as reduction in epidermal thickness to normal or almost normal normalized keratinocyte differentiation and absent keratinocyte expression of K16. No improvement defined as no improvement in epidermal thickness keratinocyte differentiation or K16 expression on keratinocytes. A binomial response was defined for each participant according to whether the participant had an improvement score of good or excellent improvement (response=1) or not (response=0). Number of participants with good or excellent improvement score are presented."|12 weeks|The Efficacy Analysis Set (EAS) population comprised of all randomized participants who took at least one dose of study medication, had at least one activity measurement at Baseline, at least one post-Baseline study visit. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2712584|NCT01154088|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Within 31-days (Days 0-30) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2712585|NCT01154088|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31-days (Days 0-30) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2713172|NCT01150409|Primary|Incidence of Hypotension Between Study Days 8 and 14 (Within 7 Days of the Initiation of Study Drug).|Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.|Day 14|||||||
2712586|NCT01154088|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4-days (Days 0-3) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2712587|NCT01154088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|Within 4-days (Days 0-3) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2712588|NCT01154088|Secondary|Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.|||Participants|||Count of Participants
2712589|NCT01154088|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs). The analysis was performed with the GSK rSBA assay.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2712590|NCT01154088|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the GSK rSBA assay.|At Day 0 and at Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||Participants|||Count of Participants
2712591|NCT01154088|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay.|At Day 0 and at Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.|||Titers||95% Confidence Interval|Geometric Mean
2712592|NCT01154088|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.|At Day 0 and Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.|||Participants|||Count of Participants
2712593|NCT01154088|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.|At Day 0 and at Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.|||Participants|||Count of Participants
2712594|NCT01154088|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers|Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Nimenrix-B Group only.|||Titers||95% Confidence Interval|Geometric Mean
2712595|NCT01154088|Primary|Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies|Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Mencevax Group only.|||Participants|||Count of Participants
2712596|NCT01154036|Secondary|Percent Change From Baseline in Hs-CRP (Phase II)|hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage Change||95% Confidence Interval|Least Squares Mean
2712731|NCT01153672|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival. Overall survival time will be censored on the last date the patient was known to be alive.|Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years||||months||Full Range|Median
2712597|NCT01154036|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)|hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2712598|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)|Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712599|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)|Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712600|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)|Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712601|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)|Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712602|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)|LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712603|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)|LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712604|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase II)|TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712605|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase I)|TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712606|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase II)|Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712781|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||up to 47 days (visit 1 to visit 6)||||Participants|||Number
2712607|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase I)|Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712608|NCT01154036|Secondary|Percent Change From Baseline in Apo A-I (Phase II)|Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712609|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)|Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712610|NCT01154036|Secondary|Percent Change From Baseline in Apo B (Phase II)|Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712611|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)|Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712612|NCT01154036|Secondary|Percent Change From Baseline in HDL-C (Phase II)|HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712613|NCT01154036|Secondary|Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)|HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712614|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase II)|TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage Change||95% Confidence Interval|Least Squares Mean
2712615|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase I)|TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2712616|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase II)|TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712782|NCT01153321|Secondary|Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes||up to 47 days (visit 1 to visit 6)||||Participants|||Number
2712617|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase I)|TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
2712618|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)||Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage of Participants|||Number
2712619|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage of Participants|||Number
2712620|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)||Week 12 (End of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage of Participants|||Number
2712621|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage of Participants|||Number
2712622|NCT01154036|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).|LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).|Baseline (Week 6) and Week 12|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
2712623|NCT01154036|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)|LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).|Baseline and Week 6 (end of Phase I )|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I|||Percentage Change||Standard Deviation|Median
2712624|NCT01154010|Primary|Inflammation Grade at Day 7|Degree and grade of ocular inflammation based on Standard Uveitis Nomenclature will be assessed at initial visit, Day 3, and Day 7 of use of the PEMF device to assess if the PEMF device decreases the duration and severity of ocular inflammation when used as an adjunctive therapy for anterior uveitis. The results posted here are from day 7. The Standard Uveitis Nomenclature scale ranges from 0 to 4, with 0 indicating a minimal level of ocular inflammation and 4 indicating the maximal level of corneal inflammation.|7 days||||units on a scale||Standard Deviation|Mean
2712625|NCT01153984|Secondary|Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples||Baseline up to approximately 4 years|No participants were analyzed for this outcome as no plasma samples were collected during the study.||||||
2712626|NCT01153984|Secondary|Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations|Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain.|Day 1|All enrolled participants.|||participants|||Number
2712627|NCT01153984|Secondary|Number of EGFR Positive Participants Classified Based on Smoking Status|"Participants were asked: Have you smoked at least 100 cigarettes in your entire life? and Do you now smoke cigarettes every day, some days, or not at all? Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'."|Day 1|All enrolled participants.|||participants|||Number
2712628|NCT01153984|Secondary|Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1|PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial.|Baseline up to approximately 4 years|All enrolled participants with available data for this outcome.|||percentage of participants|||Number
2712629|NCT01153984|Secondary|Percentage of Participants Who Were Alive One Year After Study Treatment Initiation||Year 1|All enrolled participants with available data for this outcome.|||percentage of participants|||Number
2712631|NCT01153984|Secondary|Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1|Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to approximately 4 years|All enrolled participants.|||days||95% Confidence Interval|Median
2712632|NCT01153984|Primary|Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to approximately 4 years|All enrolled participants.|||days||95% Confidence Interval|Median
2712633|NCT01153971|Secondary|DR - Time to Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population: only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.|||months||Standard Error|Mean
2712634|NCT01153971|Secondary|DR - Percentage of Participants With an Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.|||percentage of participants|||Number
2712635|NCT01153971|Secondary|Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response|DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2712636|NCT01153971|Secondary|PFS - Time to Event|Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||months||Standard Error|Mean
2712637|NCT01153971|Secondary|PFS - Percentage of Participants With an Event|Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants|||Number
2712638|NCT01153971|Secondary|Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free|PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants||95% Confidence Interval|Number
2712639|NCT01153971|Secondary|DFS - Time to Event|DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.|||months||Standard Error|Mean
2712640|NCT01153971|Secondary|DFS - Percentage of Participants With an Event|DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.|||percentage of participants|||Number
2712714|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.|||Percentage of participants||95% Confidence Interval|Number
2712641|NCT01153971|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free|DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2712642|NCT01153971|Secondary|OS - Time to Event|Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population|||months||Standard Error|Mean
2712643|NCT01153971|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population|||percentage of participants|||Number
2712644|NCT01153971|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive|OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants||95% Confidence Interval|Number
2712645|NCT01153971|Secondary|FFS - Time to Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||months||Standard Error|Mean
2712646|NCT01153971|Secondary|FFS - Percentage of Participants With an Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants|||Number
2712647|NCT01153971|Secondary|Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death|FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants||95% Confidence Interval|Number
2712648|NCT01153971|Secondary|Percentage of Participants Achieving a Response by Response Type and Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40|ITT population|||percentage of participants|||Number
2712649|NCT01153971|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)|ITT population|||percentage of participants||95% Confidence Interval|Number
2712650|NCT01153971|Primary|Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date|Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.|Month 28|ITT population|||percentage of participants||95% Confidence Interval|Number
2712651|NCT01153958|Secondary|Percentage of Participants Cured|Cure was defined as Nugent score less than 7, no symptoms of vaginal irritation (for example, pain, burning, odour or abnormal vaginal discharge). Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated bacterial vaginosis.|1 week post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.|||percentage of participants|||Number
2712652|NCT01153958|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 2 months post-treatment|Safety population included all randomized participants who used the investigational product at least once.|||participants|||Number
2712653|NCT01153958|Secondary|Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment|The grades of Lactobacilli in vaginal discharge were Grade 1 (Normal): Lactobacillus morphotypes predominate; Grade 2 (Intermediate): Mixed flora with some Lactobacilli present, but Gardnerella or Mobiluncus morphotypes also present; Grade 3 (Bacterial Vaginosis): Predominantly Gardnerella and/or Mobiluncus morphotypes, few or absent Lactobacilli.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at the time point.|||participants|||Number
2712654|NCT01153958|Secondary|Change From Baseline in Nugent Score at 2 Months Post-treatment|Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicate bacterial vaginosis.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'n' signifies those participants who were evaluated for this measure at the time point.|||units on a scale||Standard Deviation|Mean
2712655|NCT01153958|Secondary|Percentage of Participants With Relapse 1 Month Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|1 month post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.|||percentage of participants|||Number
2712656|NCT01153958|Primary|Percentage of Participants With Relapse 2 Months Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|2 months post-treatment|Full analysis set (FAS) population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.|||percentage of participants|||Number
2712657|NCT01153893|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2712658|NCT01153893|Secondary|Number of Subjects Reporting Unsolicited AEs.|"Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 31 days (Days 0-30) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2712659|NCT01153893|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).~Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.~Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2712660|NCT01153893|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any local symptom regardless of intensity grade.~Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)"|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2712688|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Secondary efficacy Population and only those participants who had a CR or PR were analyzed.|Up to 60 months|Secondary Efficacy Population|||Weeks||95% Confidence Interval|Median
2712661|NCT01153893|Secondary|Concentration of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EL.U/mL).|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2712662|NCT01153893|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A.~Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||Titres||95% Confidence Interval|Geometric Mean
2712663|NCT01153893|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||Titres||95% Confidence Interval|Geometric Mean
2712664|NCT01153893|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2712665|NCT01153893|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2712666|NCT01153893|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).|"Grade 3 symptom = severe symptom that prevented normal activity.~Solicited local symptoms assessed were pain, redness and swelling.~Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite.~Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2712667|NCT01153841|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|After the first vaccination up to study end (From Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2712668|NCT01153841|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|During the 31-day (Days 0-30) follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2712700|NCT01153724|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2712669|NCT01153841|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2712670|NCT01153841|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2712671|NCT01153841|Primary|Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)|The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.|Within the 31-day (Days 0-30) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2712672|NCT01153815|Secondary|GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points|The care giver or participants used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at the indicated time point.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2712673|NCT01153815|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsenig, -0=unchanged, +4=very marked improvement) at the indicated time points.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2712674|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at the indicated time points was calculated as the value at Weeks 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2712675|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator, physotherapist, or occupational therapist extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. Only participants with thumb spasticity who received injection in the thumb muscles were evaluated. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2712676|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2712677|NCT01153815|Secondary|Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits|Wrist treatment responders were defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||participants|||Number
2712678|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2713056|NCT01151423|Secondary|Number of TEAEs and Their Relationship to Study Drug|Number of TEAEs and their relationship to study drug were evaluated. Relationship of AEs to study drug was: related, possibly related, and unlikely/not related.|From the start of the study up to 1 month follow-up|Safety Population|||adverse events|||Number
2712679|NCT01153815|Secondary|Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score|The MAS wrist score was assessed by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Mean change from Baseline for the MAS wrist score was calculated as the value at Week 6 and Week 12 minus the value at Baseline. In a graph plotting time points on the horizontal axis (HA) and changes from Baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
2712680|NCT01153815|Primary|Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.|Baseline (Day 0) and Week 6|Full Analysis Set (FAS) Population: all randomized and treated participants. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.|||scores on a scale||Standard Deviation|Mean
2712681|NCT01153763|Secondary|Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels|LVEF was defined as the percentage of blood pumped out of the left ventricle. Change from Baseline in worst-case post Baseline was presented as no change or any increase and any decrease values. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.|Up to 60 months|All treated Population|||Participants|||Number
2712682|NCT01153763|Secondary|Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Number of participants with increase from Baseline in SBP and DBP were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as any increase to >=80 and increase to >=100 for DBP and as any increase to >=120 and increase to >=160 for SBP. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. One participant out of the 92 participants (76 BRAF V600E patients + 16 BRAF V600K patients) did not have SBP and DBP collected after baseline.|Up to 60 months|All treated Population|||Participants|||Number
2712683|NCT01153763|Secondary|Number of Participants With Change From Baseline in Temperature and Pulse Rate|Number of participants with change from Baseline in temperature and pulse rate were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as decrease to <=35, change to normal or no change and increase to >=38. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.|Up to 60 months|All treated Population|||Participants|||Number
2712684|NCT01153763|Secondary|Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades|Blood samples were collected from participants for evaluation of change from Baseline in toxicity grades in clinical chemistry and hematology parameters. The clinical chemistry parameters included alkaline phosphatase, Alanine amino transferase (ALT), Aspartate amino transferase (AST), total bilirubin, creatinine, glucose, potassium, magnesium, sodium and phosphorus. The hematology parameters included hemoglobin, total neutrophils, platelets and white blood cells (WBC). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to 60 months|All treated Population|||Participants|||Number
2712685|NCT01153763|Secondary|Number of Participants With AEs and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on All treated Population which comprised of all participants that receive at least one dose of dabrafenib.|Up to 60 months|All treated Population|||Participants|||Number
2712686|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600K Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using Kaplan-Meier model and median and 95 percent CI was presented.|From the first dose to death due to any cause (up to 60 months)|Secondary Efficacy Population|||Weeks||95% Confidence Interval|Median
2712687|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600E Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using kaplan-Meier model and median and 95 percent CI was presented.|Up to 60 months|Primary Efficacy Population|||Weeks||95% Confidence Interval|Median
2712689|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Primary efficacy Population and only those participants who had a CR or PR were analyzed.|Up to 60 months|Primary Efficacy Population|||Weeks||95% Confidence Interval|Median
2712690|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent CI. For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|Up to 60 months|Secondary Efficacy Population|||Weeks||95% Confidence Interval|Median
2712691|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent confidence interval (CI). For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|Up to 60 months|Primary Efficacy Population|||Weeks||95% Confidence Interval|Median
2712692|NCT01153763|Secondary|Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment had to have been performed at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later should have been confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Secondary efficacy analysis Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600K mutation.|Up to 60 months|Secondary Efficacy Population|||Participants|||Number
2712693|NCT01153763|Primary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment was required at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later were required to be confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Primary efficacy Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600E mutation.|Up to 60 months|Primary efficacy Population|||Participants|||Number
2712694|NCT01153724|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS|||participants|||Number
2712695|NCT01153724|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who had taken at least 1 dose of trial medication.|||participants|||Number
2712696|NCT01153724|Secondary|Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)|AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2712697|NCT01153724|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||ng||Geometric Coefficient of Variation|Geometric Mean
2712698|NCT01153724|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||percentage of olodaterol||Geometric Coefficient of Variation|Geometric Mean
2712699|NCT01153724|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||Hours||Full Range|Median
2712701|NCT01153724|Primary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2712702|NCT01153711|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS|||participants|||Number
2712703|NCT01153711|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.|||participants|||Number
2712704|NCT01153711|Secondary|Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)|AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2712705|NCT01153711|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||ng||Geometric Coefficient of Variation|Geometric Mean
2712706|NCT01153711|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2712707|NCT01153711|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Hours||Full Range|Median
2712708|NCT01153711|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2712709|NCT01153711|Primary|Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)|AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2712710|NCT01153698|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period|Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.|From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated Set|||Number of participants|||Number
2712711|NCT01153698|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last Pradaxa intake|Treated Set (All patients with non-missing information for both, the volume drainage until first dose of Pradaxa and the volume drainage from first dose of Pradaxa and onwards).|||ml||Standard Deviation|Mean
2712712|NCT01153698|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period|Major extra-surgical site bleedings include all major bleedings not occurred at surgical site|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS|||Percentage of participants||95% Confidence Interval|Number
2712713|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period|"sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.~Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism"|From last enoxaparin administration until first Pradaxa intake|TS reduced to patients with switch period.|||Percentage of participants||95% Confidence Interval|Number
2712715|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS|||Percentage of participants||95% Confidence Interval|Number
2712716|NCT01153698|Secondary|Percentage of Patients With MBE During Pre-switch Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.|||Percentage of participants||95% Confidence Interval|Number
2712717|NCT01153698|Secondary|Percentage of Patients With MBE During Total Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS|||Percentage of participants||95% Confidence Interval|Number
2712718|NCT01153698|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|TS reduced to patients with switch-/ post-switch period.|||Percentage of participants||95% Confidence Interval|Number
2712719|NCT01153698|Primary|Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period|Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated set (TS) reduced to patients with switch-/ post-switch period. TS includes all patients who received at least one dose of enoxaparin or at least one dose of Pradaxa.|||Percentage of participants||95% Confidence Interval|Number
2712720|NCT01153685|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period|The analysis was performed on the Total Vaccinated Cohort.|||Subjects|||Number
2712721|NCT01153685|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort.|||Subjects|||Number
2712722|NCT01153685|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.~Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.~Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination."|Within the 21-day post-vaccination period|The analysis was performed on the Tota Vaccinated Cohort.|||Subjects|||Number
2712723|NCT01153685|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.|Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)|During a 4-days (Day 0-3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated Cohort on subjects with available results.|||Subjects|||Number
2712724|NCT01153685|Primary|Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.|Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Fold increase||95% Confidence Interval|Mean
2712725|NCT01153685|Primary|Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.|A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Subjects|||Number
2712726|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Subjects|||Number
2712727|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Subjects|||Number
2712732|NCT01153672|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to describe progression-free survival. For progression-free survival, patients without documented disease progression or death will be treated as censored observations on the date of the last tumor assessment.|Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years||||months||Full Range|Median
2712733|NCT01153672|Primary|Duration of Response|Duration of response will be summarized for responders.|Up to approximately 5 years||||weeks||Full Range|Median
2712734|NCT01153672|Primary|Rate of Clinical Benefit According to RECIST|Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria|Up to approximately 5 years||||percentage of evaluable participants||90% Confidence Interval|Number
2712735|NCT01153633|Primary|Absolute Change of Target Ulcer From Baseline to Last Visit||12 weeks|per protocol analysis|||square centimeters||Standard Error|Least Squares Mean
2712736|NCT01153633|Primary|Healing of Target Ulcer atV6/EOS|Number of ulcers healed at V6/EOS|12 weeks|per protocol analysis|||ulcers|||Number
2712737|NCT01153633|Secondary|Condition of Wound Bed|Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS|12 Weeks|per protocol analysis|||percentage of of wound bed||Standard Deviation|Mean
2712738|NCT01153633|Secondary|Pain|Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented 'no pain' and 100 mm 'worst possible pain'.|12 Weeks|per protocol analysis|||mm||Standard Deviation|Mean
2712739|NCT01153633|Secondary|Number of Different Microganisms at V6/EoS||12 Weeks|per protocol analysis|||Number of microgasism species||Standard Deviation|Mean
2712740|NCT01153633|Primary|Percent Change of Wound Size From Baseline to Last Visit||12 Weeks|Per protocol set|||percentage change in wound size (cm2)||Standard Error|Least Squares Mean
2712741|NCT01153620|Secondary|Comparison of the Percentage of Patients With Target Wounds <50 CFU|Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application|60 minutes|||||||
2712742|NCT01153620|Secondary|Reduction in CFU|Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application|15 minutes, 30 minutes and 60 minutes|||||||
2712743|NCT01153620|Secondary|Local Tolerability: Pruritis Burning|Local tolerability after 60 minutes of treatment application.|60 minutes|||||||
2712744|NCT01153620|Primary|Reduction (log10) in Colony Forming Units|Comparison of the log10 reduction in CFU after 60 minutes of treatment application.|60 minutes|ITT population: comprising all wounds having received the study treatment for any duration (n=61).|||log 10 Colony Forming Units|Participants|Standard Deviation|Mean
2712745|NCT01153581|Primary|Skin Microvascular Responses|"Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as % max. This is measured with a Laser Doppler probes, which measures volts."|2 months|Women with and without orthostatic intolerance|||Percent of max volts||Standard Error|Mean
2712746|NCT01153581|Primary|Baroreceptor Function|"This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.~Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg."|2 months|Women with low and high orthostatic tolerance|||ms/mm Hg||Standard Error|Mean
2712747|NCT01153581|Primary|Orthostatic Tolerance|We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.|2 months||||mmHg*min||Standard Deviation|Mean
2712748|NCT01153516|Primary|Response in Glucagon AUC at Baseline vs. Following Gastric Bypass|"Changes in the glucagon Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucagon AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2.~Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle.~Total AUC was computed using the trapezoidal rule."|4-12 weeks||||pg/mL*min||95% Confidence Interval|Mean
2712749|NCT01153516|Primary|Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery|"Changes in the Insulin Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the insulin AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2.~Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle.~Total AUC was computed using the trapezoidal rule."|4-12 weeks||||uIU/mL*min||95% Confidence Interval|Mean
2712783|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||nmol*h/L||Full Range|Geometric Mean
2712750|NCT01153516|Primary|Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery|"Changes in the glucose Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucose AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2.~Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle.~Total AUC was computed using the trapezoidal rule."|4-12 weeks||||mg/dL*min||95% Confidence Interval|Mean
2712751|NCT01153503|Primary|Morphine Consumption|Morphine consumption over the first 24 hours|24 hours post surgery||||mg||Standard Deviation|Mean
2712752|NCT01153425|Secondary|Percentage of Change in Bone Volume Fraction (BVF)|Average fractional content of bone expressed in percent|Change between baseline and 12 months||||Percentage of Change||Standard Deviation|Mean
2712753|NCT01153425|Primary|Percentage of Change in Trabecular Surface-to-curve Ratio|Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C|Change between baseline and 12 months|Mean change in structural and mechanical markers of bone turnover between the two groups.|||Percentage of Change||Standard Deviation|Mean
2712754|NCT01153347|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11- point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712755|NCT01153347|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712756|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712757|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q LES-Q-SF)Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712758|NCT01153347|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712759|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712784|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||nmol*h/L||Full Range|Geometric Mean
2712760|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712761|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712762|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712763|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712764|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712765|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712766|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712767|NCT01153347|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2712768|NCT01153347|Secondary|"Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of Very Much Improved or Much Improved From Randomization (Week 8) to End of Treatment (Week 16)"|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712769|NCT01153347|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712770|NCT01153347|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712771|NCT01153347|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712772|NCT01153347|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
2712773|NCT01153347|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712774|NCT01153347|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712775|NCT01153347|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
2712776|NCT01153347|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2712777|NCT01153321|Secondary|CC16 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
2712778|NCT01153321|Secondary|Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)||up to 47 days (visit 1 to visit 6)||||Participants|||Number
2712779|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Physical Examination||up to 47 days (visit 1 to visit 6)||||Participants|||Number
2712780|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables||up to 47 days (visit 1 to visit 6)||||Participants|||Number
2712785|NCT01153321|Secondary|Time to Cmax (Tmax) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||hours||Full Range|Median
2712786|NCT01153321|Secondary|Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State|Steady state pharmacokinetic (PK) profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||nmol/L||Full Range|Geometric Mean
2712787|NCT01153321|Secondary|Neutrophils in Blood (Post-LPS Challenge)|Neutrophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712788|NCT01153321|Secondary|Neutrophils in Blood (Pre-LPS Challenge)|Neutrophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712789|NCT01153321|Secondary|Monocytes in Blood (Post-LPS Challenge)|Monocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712790|NCT01153321|Secondary|Monocytes in Blood (Pre-LPS Challenge)|Monocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712791|NCT01153321|Secondary|Lymphocytes in Blood (Post-LPS Challenge)|Lymphocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712792|NCT01153321|Secondary|Lymphocytes in Blood (Pre-LPS Challenge)|Lymphocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712793|NCT01153321|Secondary|Eosinophils in Blood (Post-LPS Challenge)|Eosinophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712794|NCT01153321|Secondary|Eosinophils in Blood (Pre-LPS Challenge)|Eosinophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712795|NCT01153321|Secondary|Basophils in Blood (Post-LPS Challenge)|Basophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712796|NCT01153321|Secondary|Basophils in Blood (Pre-LPS Challenge)|Basophils in blood pre-LPS challenge (Day 10)|day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712797|NCT01153321|Secondary|CC16 Concentration in Blood (Post-LPS Challenge)|CC16 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.|||ng/mL||Standard Error|Least Squares Mean
2712798|NCT01153321|Secondary|CC16 Concentration in Blood (Pre-LPS Challenge)|CC16 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Three patients had missing observations.|||ng/mL||Standard Error|Least Squares Mean
2712799|NCT01153321|Secondary|SP-D Concentration in Blood (Post-LPS Challenge)|SP-D concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
2712800|NCT01153321|Secondary|SP-D Concentration in Blood (Pre-LPS Challenge)|SP-D concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
2712801|NCT01153321|Secondary|TNF-α Concentration in Blood (Post-LPS Challenge)|TNF-α concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712802|NCT01153321|Secondary|TNF-α Concentration in Blood (Pre-LPS Challenge)|TNF-α concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712803|NCT01153321|Secondary|IL-8 Concentration in Blood (Post-LPS Challenge)|IL-8 concentration in blood post-LPS challenge (Day 11)|day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712804|NCT01153321|Secondary|IL-8 Concentration in Blood (Pre-LPS Challenge)|IL-8 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712805|NCT01153321|Secondary|IL-6 Concentration in Blood (Post-LPS Challenge)|IL-6 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712806|NCT01153321|Secondary|IL-6 Concentration in Blood (Pre-LPS Challenge)|IL-6 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712807|NCT01153321|Secondary|IL-1β Concentration in Blood (Post-LPS Challenge)|IL-1β concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712808|NCT01153321|Secondary|IL-1β Concentration in Blood (Pre-LPS Challenge)|IL-1β concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712809|NCT01153321|Secondary|CCL2 Concentration in Blood (Post-LPS Challenge)|CCL2 concentration in blood post-LPS challenge (Day 11).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712810|NCT01153321|Secondary|CCL2 Concentration in Blood (Pre-LPS Challenge)|CCL2 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
2712811|NCT01153321|Secondary|SAA Concentration in Blood (Post-LPS Challenge)|SAA concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
2712812|NCT01153321|Secondary|SAA Concentration in Blood (Pre-LPS Challenge)|SAA concentration in blood pre-LPS challenge (Day 10).|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
2712813|NCT01153321|Secondary|SP-D Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||ng/mL||Standard Error|Least Squares Mean
2712814|NCT01153321|Secondary|RANTES Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
2712815|NCT01153321|Secondary|IL-8 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
2712816|NCT01153321|Secondary|IL-6 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
2712817|NCT01153321|Secondary|IL-1β Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
2712818|NCT01153321|Secondary|CCL2 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
2712819|NCT01153321|Secondary|TNF α Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
2712820|NCT01153321|Secondary|Macrophages in BAL (Post-LPS Challenge)|Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Deviation|Least Squares Mean
2712821|NCT01153321|Secondary|Neutrophils in BAL (Post-LPS Challenge)|Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712822|NCT01153321|Secondary|Lymphocytes in BAL (Post-LPS Challenge)|Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712823|NCT01153321|Secondary|Eosinophils in BAL (Post-LPS Challenge)|Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712824|NCT01153321|Secondary|Biopsy Epithelium Grade (Post-LPS Challenge)|Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.|||Units on a scale||Standard Error|Least Squares Mean
2712825|NCT01153321|Secondary|Biopsy PAS Reaction Grade (Post-LPS Challenge)|Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.|||Units on a scale||Standard Error|Least Squares Mean
2712826|NCT01153321|Secondary|CD3+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
2712827|NCT01153321|Secondary|CD45+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
2712828|NCT01153321|Secondary|Total Macrophages in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
2712829|NCT01153321|Secondary|Total Neutrophils in Biopsy Sample (Post-LPS Challenge)|Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
2712830|NCT01153321|Primary|Absolute Monocyte Count in BAL Post-LPS Challenge|Monocyte count in BAL post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
2712831|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.|Week 144|All participants with CD4+ cell count measurements at Week 144 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712832|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.|Week 132|All participants with CD4+ cell count measurements at Week 132 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712833|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.|Week 120|All participants with CD4+ cell count measurements at Week 120 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712834|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.|Week 108|All participants with CD4+ cell count measurements at Week 108 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712835|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.|Week 96|All participants with CD4+ cell count measurements at Week 96 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712836|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.|Week 84|All participants with CD4+ cell count measurements at Week 84 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712837|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.|Week 72|All participants with CD4+ cell count measurements at Week 72 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712838|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.|Week 60|All participants with CD4+ cell count measurements at Baseline are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712839|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.|Week 48|All participants with CD4+ cell count measurements at Week 48 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712840|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.|Week 36|All participants with CD4+ cell count measurements at Week 36 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712841|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.|Week 24|All participants with CD4+ cell count measurements at Week 24 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712842|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.|Week 12|All participants with CD4+ cell count measurements at Week 12 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712843|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.|Week 4|All participants with CD4+ cell count measurements at Week 4 are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712844|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.|Baseline|All participants with CD4+ cell count measurements at Baseline are included.|||CD4+ cells/μL||Standard Deviation|Mean
2712845|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with HIV-1 RNA results at Week 144.|||log10 copies/mL||Standard Deviation|Mean
2712846|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with HIV-1 RNA results at Week 132.|||log10 copies/mL||Standard Deviation|Mean
2712847|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with HIV-1 RNA results at Week 120.|||log10 copies/mL||Standard Deviation|Mean
2712848|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with HIV-1 RNA results at Week 108.|||log10 copies/mL||Standard Deviation|Mean
2712849|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with HIV-1 RNA results at Week 96.|||log10 copies/mL||Standard Deviation|Mean
2712850|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with HIV-1 RNA results at Week 84.|||log10 copies/mL||Standard Deviation|Mean
2712851|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with HIV-1 RNA results at Week 72.|||log10 copies/mL||Standard Deviation|Mean
2712852|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with HIV-1 RNA results at Week 60.|||log10 copies/mL||Standard Deviation|Mean
2712853|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with HIV-1 RNA results at Week 48.|||log10 copies/mL||Standard Deviation|Mean
2712854|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with HIV-1 RNA results at Week 36.|||log10 copies/mL||Standard Deviation|Mean
2712855|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with HIV-1 RNA results at Week 24.|||log10 copies/mL||Standard Deviation|Mean
2712856|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with HIV-1 RNA results at Week 12.|||log10 copies/mL||Standard Deviation|Mean
2712857|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with HIV-1 RNA results at Week 4.|||log10 copies/mL||Standard Deviation|Mean
2712858|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with HIV-1 RNA results at Baseline.|||log10 copies/mL||Standard Deviation|Mean
2712859|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.|||U/liter||Standard Deviation|Mean
2712860|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.|||U/liter||Standard Deviation|Mean
2712861|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.|||U/liter||Standard Deviation|Mean
2712862|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.|||U/liter||Standard Deviation|Mean
2712863|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.|||U/liter||Standard Deviation|Mean
2712864|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.|||U/liter||Standard Deviation|Mean
2712865|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.|||U/liter||Standard Deviation|Mean
2712898|NCT01152697|Secondary|Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.|12 months|Six participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
2712866|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.|||U/liter||Standard Deviation|Mean
2712867|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.|||U/liter||Standard Deviation|Mean
2712868|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.|||U/liter||Standard Deviation|Mean
2712869|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.|||U/liter||Standard Deviation|Mean
2712870|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.|||U/liter||Standard Deviation|Mean
2712871|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.|||U/liter||Standard Deviation|Mean
2712872|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.|||U/liter||Standard Deviation|Mean
2712873|NCT01153009|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2712874|NCT01153009|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
2712875|NCT01153009|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2712876|NCT01153009|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2712899|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|12 months|Six participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
2712877|NCT01153009|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
2712878|NCT01153009|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2712879|NCT01152996|Secondary|Change From Baseline in SDS Family Life/Home Responsibilities Subscale|The change between the Sheehan Disability family life/home responsibilities subscale score at each assessed visit and family life/home responsibilities subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712880|NCT01152996|Secondary|Change From Baseline in SDS Social Life Subscale|The change between the Sheehan Disability social life subscale score at each assessed visit and social life subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712881|NCT01152996|Secondary|Change From Baseline in SDS Work/School Subscale|The change between the Sheehan Disability work/school subscale score at each assessed visit and work/school subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712882|NCT01152996|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The change between the SDS total score at each assessed visit and the total score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712883|NCT01152996|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|"The change between CGI-S score at each assessed visit and CGI-S score at baseline. The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill). Higher scores indicate greater severity of illness."|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712884|NCT01152996|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The change between HAM-A score at each assessed visit and HAM-A score at baseline. HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712885|NCT01152996|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The change between MADRS total score at each assessed visit and MADRS score at baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
2712886|NCT01152996|Primary|Treatment-Emergent Adverse Events Leading to Study Discontinuation|Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set|||participants|||Number
2712900|NCT01152697|Secondary|Treatment Adherence Score as Measured at 12 Months|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|12 months|Seven participants were administered and completed this measure at 12 months.|||Percentage of doses||Standard Deviation|Mean
2712901|NCT01152697|Secondary|Days Homeless Out of the Previous 6 Months as Measured at 12 Months|Subjects will be asked how many days they have been homeless|12 months|Six participants were administered and completed this measure at 12 months.|||days||Standard Deviation|Mean
2712887|NCT01152996|Primary|Number of Participants With Serious Treatment-Emergent Adverse Events|Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|Over the 52 week period|Safety set|||participants|||Number
2712888|NCT01152996|Primary|Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set|||participants|||Number
2712889|NCT01152814|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using the PP dataset.|||Percentage of participants||95% Confidence Interval|Number
2712890|NCT01152814|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using the PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2712891|NCT01152814|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.|||Number of participants|||Number
2712892|NCT01152814|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation.|||Percentage of participants||95% Confidence Interval|Number
2712893|NCT01152788|Secondary|Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)|To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.|Over study period, up to 22 months||||participants|||Number
2712894|NCT01152788|Secondary|Overall Survival|For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.|From randomization to death of any cause, up to 22 months||||months||95% Confidence Interval|Median
2712895|NCT01152788|Secondary|Response Rate|Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures < 10 mm (Note: continue to record the measurement even if < 10 mm and considered CR). Residual lesions (other than nodes < 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.|From the start of study treatment until the end of treatment (before disease progression)||||percentage of participants||95% Confidence Interval|Number
2712896|NCT01152788|Primary|Progression Free Survival|Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.|From randomization to progression or death, up to 22 months|treated population|||years||95% Confidence Interval|Median
2712897|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|12 months|Seven participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
2712902|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months|"Satisfaction will be measured by a seven item inventory taken by the participant.~Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|12 months|Six participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
2712903|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-12 months|Six participants were administered and completed measurement with the SOFAS at 12 months. Only data for these participants was analyzed for change from baseline to 12 months.|||units on a scale||Standard Deviation|Mean
2712904|NCT01152697|Secondary|Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.~Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|12 months|12 participants were administered and completed measurement with the CGI at 12 months.|||units on a scale||Standard Deviation|Mean
2712905|NCT01152697|Secondary|Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks|The frequency of health resource use will be measured through interview of the participant.|25 weeks|17 participants were administered and completed this measure at week 25.|||days||Standard Deviation|Mean
2712906|NCT01152697|Secondary|Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks|"The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.~There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.~Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the PANSS at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
2712907|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks|"Satisfaction will be measured by a seven item inventory taken by the participant.~Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|25 weeks|17 participants were administered and completed this measure at week 25.|||units on a scale||Standard Deviation|Mean
2712908|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-25 weeks|17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
2712909|NCT01152697|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.~Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|Baseline-25 weeks|17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25.|||units on a scale||Standard Deviation|Mean
2712910|NCT01152697|Secondary|Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks|"The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.~Scale Range: 18-126 Lower scores represent improved outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
2712911|NCT01152697|Secondary|Frequency of Health Resource Use Throughout Months 10, 11, and 12|The frequency of health resource use will be measured through interview of the participant.|Month 1-3, Month 10-12|Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes.|||days||Standard Deviation|Mean
2712965|NCT01152385|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||mg/dL||Standard Deviation|Mean
2712966|NCT01152385|Secondary|Percentage Change in Triglycerides||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
2712912|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|Baseline-25 weeks|19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes.|||units on a scale||Standard Deviation|Mean
2712913|NCT01152697|Primary|Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Baseline-25 weeks|16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
2712914|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Baseline-25 weeks|15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
2712915|NCT01152697|Primary|Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|Baseline-25 weeks|17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||Percentage of doses||Standard Deviation|Mean
2712916|NCT01152697|Primary|Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks|Subjects will be asked how many days they have been homeless|Baseline-25 weeks|26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||days||Standard Deviation|Mean
2712917|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in the Pittsburgh Sleep Quality Index (PSQI) in Women After 6 Months, as Compared to Baseline.|"Pittsburgh Sleep Quality Index (PSQI) Questionnaire is a validated questionnaire that assesses the quality and quantity of sleep and sleep disorders.This survey is designed to identify good and poor sleepers and has a score scale that ranges from 0-21 with 0 being good quality of sleep and 21 being poor quality of sleep and/or indicating as having a sleep disorder. A more positive mean change in the PSQI over time indicates a worsening of sleep. A more negative mean change in the PSQI over time indicates an improvement in sleep."|Baseline and 6 months|intention to treat|||units on a scale||Standard Deviation|Mean
2712918|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Sexual Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
2712919|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Bone Density in Women After 6 Months, as Compared to Baseline.|The mean change in bone mineral density (BMD), represented by T-scores, was assessed by calcaneal ultrasound in women taking melatonin (3 mg) or placebo nightly at baseline and after 6 months. A T-score is a comparison of a subject's BMD to that of a healthy 30 year old female of the same ethnicity. The more negative the T-score, the worse the BMD. Osteoporosis or brittle bone disease is defined as a T-score -2.5 or less. A more negative mean change in a T-score would indicate a worsening of BMD. A more positive mean change in a T-score would indicate an improvement of BMD.|Baseline and 6 months|intention to treat|||T-score||Standard Deviation|Mean
2712920|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Psychosocial Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
2712921|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Type-1 Collagen Cross-linked N-telopeptide (NTX) Levels in Women After 6 Months, as Compared to Baseline.|Type-1 collagen cross-linked N-telopeptide (NTX) levels were measured in the serum of women at baseline and after taking placebo or melatonin (3 mg) nightly for 6 months. NTX, reported as bone collagen equivalents (BCE), is released from bone due to the actions of osteoclasts or bone breakdown cells. A more positive mean change in NTX levels (6 months - baseline) could result in a worsening of bone mineral density due to an increase in bone breakdown whereas a more negative mean change in NTX levels could result in an improvement in bone mineral density due to a decrease in bone breakdown.|Baseline and 6 months|intention to treat|||nM BCE||Standard Deviation|Mean
2712922|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Vasomotor Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
2712923|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Physical Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
2712924|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline|Osteocalcin is a measure of osteoblast activity because it is secreted from osteoblasts. Osteocalcin levels were measured in the serum of women at baseline and after 6 months of taking placebo or melatonin (3 mg) and the data are reported as ng/mL. Osteoblasts are bone-forming cells so a more positive mean change in osteoblast activity over time (6 months - baseline) could indicate an improvement in bone mineral density. A more negative mean change in osteocalcin levels over time (6 months - baseline) could indicate a worsening of bone mineral density.|Baseline and 6 months|intention to treat|||ng/mL||Standard Deviation|Mean
2712925|NCT01152554|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
2712926|NCT01152554|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
2712927|NCT01152554|Secondary|Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
2712928|NCT01152554|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
2712929|NCT01152554|Secondary|Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52|"The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 52|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||percentage of patients analyzed|||Number
2712930|NCT01152554|Secondary|Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24|"The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 24|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||percentage of participants analyzed|||Number
2712967|NCT01152385|Secondary|Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
2712931|NCT01152554|Primary|Frequency of Patients Experiencing Serious Adverse Events (SAEs)|The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.|||percentage of participants analyzed|||Number
2712932|NCT01152554|Primary|Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.|||percentage of participants analyzed|||Number
2712933|NCT01152554|Primary|Frequency of Patients Experiencing at Least One Adverse Event (AE)|The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.|||percentage of participants analyzed|||Number
2712934|NCT01152515|Secondary|Time of Extubation|Time of extubation : time between 'stopping of propofol' and 'extubation'|1 hr||||min||Full Range|Median
2712935|NCT01152515|Primary|The Grade of Coughing During Extubation|Grade of cough was assessed on a four-point scale (0=no coughing, 1=single cough, 2=more than one episode of nonsustained coughing, 3=sustained and repetitive coughing with head lift).|2 min||||participants|||Number
2712936|NCT01152515|Primary|HR Changes During Extubation||10 min||||beat/min||Standard Deviation|Mean
2712937|NCT01152515|Secondary|Time of Awake|Time of BIS > 80 : time between 'stopping of propofol'|1 hour||||min||Full Range|Median
2712938|NCT01152515|Primary|Mean Arterial Pressure Changes During Extubation||10 min||||mmHg||Standard Deviation|Mean
2712939|NCT01152450|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Assessed by the patient's electronic diary (eDiary incorporated in the AM2+ device), obtained during the last week of each period of randomised treatment.|Baseline and during week 4|FAS|||Night awakenings||Standard Error|Mean
2712940|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS|||Puffs||Standard Error|Mean
2712941|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS|||Puffs||Standard Error|Mean
2712942|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS|||Puffs||Standard Error|Mean
2712943|NCT01152450|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent (weekly means obtained during the last week of each period of randomised treatment will be compared).|Baseline and during week 4|FAS|||Percent||Standard Error|Mean
2712944|NCT01152450|Secondary|PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres/min.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L/min||Standard Error|Mean
2712945|NCT01152450|Secondary|FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
2712946|NCT01152450|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS|||L/min||Standard Error|Mean
2712947|NCT01152450|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
2712948|NCT01152450|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
2712949|NCT01152450|Secondary|Peak FVC Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
2712968|NCT01152385|Secondary|Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
2712950|NCT01152450|Secondary|FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
2712951|NCT01152450|Secondary|FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
2712952|NCT01152450|Secondary|Trough Forced Vital Capacity (FVC) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FVC is defined as FVC value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
2712953|NCT01152450|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 is defined as FEV1 value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
2712954|NCT01152450|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the evening trial-drug inhalation at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
2712955|NCT01152450|Secondary|FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
2712956|NCT01152450|Secondary|FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
2712957|NCT01152450|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS|||L/min||Standard Error|Mean
2712958|NCT01152450|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS|||L/min||Standard Error|Mean
2712959|NCT01152450|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response|Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|Full Analysis Set (FAS) defined as all treated patients who had baseline data and at least 1 on-treatment efficacy measurement after 4 weeks on treatment within a period.|||L||Standard Error|Mean
2712960|NCT01152437|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)|Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.|day 8|Randomised set for wild-type group and treated set for mutated group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2712961|NCT01152437|Secondary|Overall Survival (OS) Time|OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till death, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.|||Days||95% Confidence Interval|Median
2712962|NCT01152437|Secondary|Progression Free Survival (PFS)|PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.|||Days||95% Confidence Interval|Median
2712963|NCT01152437|Primary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Treated Set. Primary endpoint for the population of patients with KRAS mutated tumours.|||Percentage of Participants||90% Confidence Interval|Number
2712964|NCT01152437|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set. Primary endpoint for the population of patients with KRAS wildtype tumours.|||Percentage of Participants|||Number
2712973|NCT01152359|Secondary|Change in Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire From Baseline to 48 Weeks|change in obesity-specific health-related quality of life as measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire total score from baseline to 48 weeks Minimum 0 Maximum 100 Higher score means better|Baseline, 48 weeks||||score on a scale||95% Confidence Interval|Mean
2712974|NCT01152359|Secondary|Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)||48 weeks||||percentage of deviation from goal||95% Confidence Interval|Mean
2712975|NCT01152359|Primary|Percent Change in Body Weight From Baseline to 48 Weeks||Baseline, 48 weeks||||percentage of weight change||95% Confidence Interval|Mean
2712976|NCT01152307|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs|2 weeks, on average|||||||
2712977|NCT01152307|Primary|Depression Knowledge|Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).|2 weeks, on average|Participants were randomized to receive the DVD and booklet.|||percent of correct responses||Standard Deviation|Mean
2712978|NCT01152294|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs|2 weeks, on average|||||||
2712979|NCT01152294|Primary|Menopause Knowledge|Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)|2 weeks, on average|Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.|||Percentage (0-100%)||Standard Deviation|Mean
2712980|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck|CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging. CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160. An increase in CPI reflected an increase in blood flow. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2712981|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.|||ratio||Standard Error|Least Squares Mean
2712982|NCT01152190|Secondary|Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.|||ratio||Standard Error|Least Squares Mean
2712983|NCT01152190|Primary|Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 8|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.|||ratio||Standard Error|Least Squares Mean
2712984|NCT01152112|Secondary|Subject Self-reported Pain Score Occurring During the Treatment Procedure|Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)|1 hour post treatment|||||||
2712985|NCT01152112|Secondary|Percent of Subjects That Achieve 100% Removal of Target Pathology|Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.|Three months post treatment|||||||
2712986|NCT01152112|Primary|Percent Reduction in Target Pathology Volume|Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment|Three months post treatment|A total of 108 pathologies were removed in 74 patients. Among the 108 pathologies removed, 53 were removed in the office setting (28 myomas, 25 polyps) and 55 were removed in the ASC setting (14 myomas, 41 polyps).|||percentage of fibriods/polyps|Fibroids and Polyps|95% Confidence Interval|Mean
2712987|NCT01152021|Secondary|Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)|Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period|During sedation, recovery and overnight, up to 24 hours|Enrollment was slow and during enrollment for this study, a paper from Cincinnati Children Hospital Medical Center compared use of dexmedetomidine and propofol in children undergoing MRI, which answered most of the questions that this study wanted to address. With the publication of these results, the investigator decided to discontinue this study.||||||
2712989|NCT01151904|Secondary|Percentage of Responders With an IOP Reduction ≥20% From Baseline|IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.||||||
2712990|NCT01151904|Secondary|Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 2, Week 6|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.||||||
2712991|NCT01151904|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.||||||
2712992|NCT01151852|Secondary|Safety and Tolerability of Imatinib|percentage of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of imatinib re-challenge in this patient population|Up to 3years||||percentage of participants|||Number
2712993|NCT01151852|Secondary|Overall Survival(OS) and Time to Progression(TTP)|To compare the overall survival (OS) and time to progression (TTP) in both arms of the study|Up to 3years||||Months||95% Confidence Interval|Median
2712994|NCT01151852|Secondary|Response Rate|"Tumour responses were initially determined by the local investigators in accordance with RECIST 1.0.Treatment decisions were based on local onsite radiological review. All imaging data were subsequently collected, anonymised, and reviewed centrally in a double-blind manner by two external academic radiology reviewers.~Response assessment was determined in a masked central review by use of RECIST1.1."|Up to 12weeks||||percentage of participants|||Number
2712995|NCT01151852|Secondary|Progression Free Survival|To compare PFS assessed by investigators|up to 12 weeks||||Months||95% Confidence Interval|Median
2712996|NCT01151852|Secondary|Disease Control Rate|"Inclusion of complete response, partial response or stable disease~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD."|up to 12 weeks||||percentage of participants|||Number
2712997|NCT01151852|Primary|Progression-free Survival|To compare the progression free survival (PFS) assessed by the blinded independent central review following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with unresectable or metastatic GIST following failure of at least prior imatinib and sunitinib therapies|up tp12 weeks||||Months||95% Confidence Interval|Median
2712998|NCT01151761|Secondary|Median Time to Overall Survival|The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.|18 months||||months||95% Confidence Interval|Median
2712999|NCT01151761|Secondary|Liver Transplant Conversion Rate|The ability to successfully perform liver transplant among patients who initially have tumor >3 cm|12 months||||participants|||Number
2713000|NCT01151761|Secondary|Freedom From Local Progression at 12 Months|the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk|12 months|Neither of the two patients that participated in the study had a local recurrence prior to dying.|||percentage of patients|||Number
2713001|NCT01151761|Secondary|Liver Transplant Rate|The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm|12 months||||participants|||Number
2713002|NCT01151761|Secondary|Overall Survival at 12 Months|the estimated probability for the percentage of participants with overall survival at 12 months.|12 months|There were only two patients analyzed. Please take that under advisement when looking at the results.|||probability|||Number
2713003|NCT01151761|Secondary|Serum CA 19-9 Levels|Initial level of Cancer antigen 19-9|12 months||||U/ml||Full Range|Mean
2713004|NCT01151761|Secondary|Pathologic Complete Response Rate|Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.|12 months||||participants|||Number
2713005|NCT01151761|Primary|Progression-free Survival at 12 Months|Progression free survival is defined to be the time to progression of disease or death.|12 months||||participants|||Number
2713006|NCT01151618|Primary|Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique|Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.|2 hours|All participants that completed the protocol were analyzed.|||breaths|||Number
2713007|NCT01151618|Primary|Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator|Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.|2 hours|All participants that completed the protocol were analyzed.|||Participants|||Count of Participants
2713020|NCT01151449|Secondary|Duration of Radiologic Response|The duration of radiologic response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.||||months|||Number
2713008|NCT01151618|Primary|Detection of Expiratory Flow Limitation|"Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).~Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).~Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL."|within 2 hours|All participants that completed the protocol were analyzed.|||cmH2O*s/L||90% Confidence Interval|Least Squares Mean
2713009|NCT01151579|Secondary|Total Number of Participants With Arrhythmias|Documented new arrhythmia occurring during study.|Five days|Number of patients for whom arrhythmias occurred within 5 days after treatment initiation.|||participants|||Number
2713010|NCT01151579|Secondary|Arrhythmias|Any new arrhythmia documented in the medical record that occurred between breathing treatments.|15 minutes after each treatment for average of 3 to 5 days|The percentage of arrhythmias among the number of breathing treatments.|||percent|||Number
2713011|NCT01151579|Primary|Heart Rate in Beats Per Minute|Average difference in Heart rate between pre and post breathing treatments|Five days|Average change in heart rate from baseline to final breathing treatment.|||bpm|Participants|Standard Deviation|Mean
2713012|NCT01151553|Primary|Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome|Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve|One year|Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.||||||
2713013|NCT01151540|Secondary|Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency|Number of participants with an increase in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.|Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF|Efficacy Analysis Set included all participants with evaluable efficacy data.|||Percentage of participants|||Number
2713014|NCT01151540|Secondary|Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders)|Categorized percent change in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used.|Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF|Efficacy Analysis Set included all participants with evaluable efficacy data.|||Percentage of participants|||Number
2713015|NCT01151540|Secondary|Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures|Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Weeks, 12, 24, 32, 40, 52 and 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure frequency, Absence seizure, Atypical absence seizure, Myoclonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, and Unclassified epileptic seizure. This data was based on the diary data collected for 7 days after each visit. Seizure frequency was counted based on the classification established by the ILAE. The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.|Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF|Efficacy Analysis Set included all participants with evaluable efficacy data.|||Percent Change in Seizure Frequency||Full Range|Median
2713016|NCT01151540|Secondary|Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days)|Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period of Study 304 as the baseline and the total seizure frequency per 28 days at Weeks 12, 24, 32, 40, 52 and Week 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].|Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF|Efficacy Analysis Set included all participants with evaluable efficacy data.|||Percent Change in Seizure Frequency||Full Range|Median
2713017|NCT01151540|Secondary|Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)|"The sum of the frequencies of tonic seizures and atonic seizures was defined as the tonic-atonic seizure frequency. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period in Study 304 as the baseline and the tonic-atonic seizure frequency at Weeks 12, 24, 32, 40, 52 and Week 52 Last Observation Carried Forward (LOCF) as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period."|Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF|Efficacy Analysis Set included all participants with evaluable efficacy data.|||Percent Change in Seizure Frequency||Full Range|Median
2713018|NCT01151540|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide|Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months|Safety analysis set included all treated participants.|||Participants|||Number
2713021|NCT01151449|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.|Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 3 months|Inadequate data for PFS estimates as only 6 patients were accrued in the study.||||||
2713022|NCT01151449|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.|Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 6 months|Inadequate data for PFS estimates as only 6 patients were accrued in the study.||||||
2713023|NCT01151449|Primary|Overall Response Rate Using RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.|From start of treatment until disease progression or removal from treatment.||||participants|||Number
2713024|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713025|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713026|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713027|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713028|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713029|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713030|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713031|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713032|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713033|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713034|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713035|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713036|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713037|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713038|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713039|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713040|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713041|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713042|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713043|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713044|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Error|Mean
2713045|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713046|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713047|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale||Standard Deviation|Mean
2713048|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale||Standard Error|Mean
2713049|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
2713050|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale||Standard Deviation|Mean
2713051|NCT01151423|Secondary|PD: Coagulation Factor VIII Clotting Activity (FVIII:C) Over Time|The change from baseline in FVIII:C concentration was measured at different ime points.|From the start of the study up to 1 month follow-up (i.e., at Baseline, Days 1 and 2 of daily PE, last day of daily PE, Day 1 after daily PE, Weeks 1, 2, 3, and 4 after daily PE, Days 3 and 7 of FU and at the 1-month FU visit).|Safety Population|||Percentage of FVIII:C activity||Standard Deviation|Mean
2713052|NCT01151423|Secondary|Pharmacodynamics: Von Willebrand Factor Antigen (vWF:Ag) Over Time|The change from baseline in vWF:Ag concentration was measured at different time points.|From the start of the study drug up to 1 month follow-up (i.e., at Baseline, Days 1 and 2 of daily PE, last day of daily PE, Day 1 after daily PE, Weeks 1, 2, 3, and 4 after daily PE, Days 3 and 7 of FU and at the 1-month FU visit).|Safety Population|||Percentage of vWF:Ag||Standard Deviation|Mean
2713053|NCT01151423|Secondary|Pharmacodynamics (PD): Ristocetin Cofactor (RICO) Activity Over Time|The change from baseline in RICO activity was measured at different time points.|From the start of the study up to 1 month follow-up (i.e., at Baseline, Days 1 and 2 of daily PE, last day of daily PE, Day 1 after daily PE, Weeks 1, 2, 3, and 4 after daily PE, Days 3 and 7 of FU and at the 1-month FU visit).|Safety Population|||percentage of RICO activity||Standard Deviation|Mean
2713054|NCT01151423|Secondary|Plasma Concentrations of Caplacizumab|The concentration of caplacizumab in plasma was determined at different time points. pharmacokinetics (PK) Population: the PK Population consisted of all subjects who received the study drug and for whom the primary PK data are considered to be sufficient and interpretable.|From the start of the study up to 1 month follow-up (i.e., at Baseline, Days 1 and 2 of daily PE, last day of daily PE, Day 1 after daily PE, Weeks 1, 2, 3, and 4 after daily PE, Days 3 and 7 of FU and at the 1-month FU visit).|PK Population, no PK data were generated for the subjects in the placebo group|||ng/mL||Standard Error|Mean
2713055|NCT01151423|Secondary|Number of Participants Who Developed Treatment-emergent Anti-Drug Antibodies (ADA)|The development of anti-drug antibodies (ADA) was monitored from the start of the study until last follow-up visit.|From the start of the study until last follow-up visit|Number of subjects from the Safety Population with data available|||Participants|||Count of Participants
2713264|NCT01149486|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2713057|NCT01151423|Secondary|Number and Percentage of Subjects With TEAEs by Severity|Number and percentage of subjects with TEAEs by severity. The severity grades of AEs were defined as: mild, moderate, and severe.|From the start of the study up to 1 month follow-up|Safety Population|||Participants|||Count of Participants
2713058|NCT01151423|Secondary|Number of Treatment-emergent Adverse Events (TEAEs) by Severity|Number and severity of TEAEs were evaluated. The severity grades of AEs were defined as: mild, moderate, and severe. Note: the numbers listed do not include the TEAEs with missing severity.|From the start of the study up to 1 month follow-up|Safety Population|||adverse events|||Number
2713059|NCT01151423|Secondary|Number and Percentage of Subjects With PE Related AEs|Number and percentage of subjects with PE related AEs.|From the start of the study up to 1 month follow-up|ITT Population|||Participants|||Count of Participants
2713060|NCT01151423|Secondary|Number of PE Related Adverse Events|Number of PE treatment-related adverse events (AEs).|From the start of the study up to 1 month follow-up|ITT Population|||adverse events|||Number
2713061|NCT01151423|Secondary|Mortality|Total mortality up to 1 month follow-up.|From the start of the study up to 1 month follow-up|ITT Population|||Participants|||Count of Participants
2713062|NCT01151423|Secondary|Number of Participants With Resolution of TTP-related Signs or Symptoms|"Resolution or improvement (improvement of ≥ 1 grade in the Common Terminology Criteria for Adverse Events [CTCAE] v4.0 scale) of TTP-related signs and symptoms as captured on physical examination and as adverse events. This endpoint was only evaluated for resolution."|End of daily PE treatment period (median [min, max] duration of exposure to study drug of 6 [2, 36] days), end of study treatment period (median [min, max] duration of exposure to study drug of 36.5 [2, 90] days) and at 1 month follow-up|ITT Population|||Participants|||Count of Participants
2713063|NCT01151423|Secondary|Resolution of Non-focal Neurological Symptoms|Resolution of non-focal neurological symptoms as defined by neurocognitive function at complete remission, measured by a Computerised Neuropsychological Test Battery(CNTB) (adults only). The CNTB included 6 modules: word list learning and selective reminding (WLL/SR), choice reaction time (CRT), visual memory (VMEM), simple reaction time (SRT), working memory (WMEM), and word list learning and delayed recall (WLL/DR). The 6 tasks are rated as a percentage correct (for CRT and SRT, the percentage correct corresponds to the percentage hits) and the mean score from these provides the CNTB summary score (range: 0-100). A higher CNTB summary score indicates better neuropsychological functioning.|From Baseline till the 12-month FU visit|The Computerized Neuropsychological Test Battery (CNTB) was completed by a low proportion of subjects with baseline data available for only 3 subjects in the caplacizumab and 4 subjects in the placebo group and 12 month post-discharge data available for 10 and 6 subjects, respectively.|||score on a scale||Standard Deviation|Mean
2713064|NCT01151423|Secondary|The Maximum Number of Consecutive Days Per Subject Where There Was no Interruption of PE During the Initial Daily PE Period|The maximum number of consecutive days per subject where there was no interruption of PE during the initial daily PE period.|During the initial daily PE period, with a median (min, max) duration of exposure to study drug of 6 (2, 36) days|Number of subjects from the ITT Population with data available|||days||Standard Deviation|Mean
2713065|NCT01151423|Secondary|Number of Days With at Least One PE Administration During the Total Course of the Study|Number of days for PE was evaluated. This implies the number of days with at least one PE administration during the total course of the study.|During the total course of the study (from Screening till the 12-month follow-up [FU] visit)|Number of subjects from the ITT Population with data available|||days||Standard Deviation|Mean
2713066|NCT01151423|Secondary|Total Volume of Plasma Administered During the Initial Daily PE Period|The total volume of plasma administered during the initial daily PE period was measured.|During the initial daily PE period, with a median (min, max) duration of exposure to study drug of 6 (2, 36) days|Number of subjects from the ITT Population with data available|||mL||Standard Deviation|Mean
2713067|NCT01151423|Secondary|Number of Daily PE Sessions During the Initial Daily PE Period|Number of daily PE sessions during the initial daily PE period which could include more than 1 PE per day was evaluated.|During the initial daily PE period, with a median (min, max) duration of exposure to study drug of 6 (2, 36) days|Number of subjects from the ITT Population with data available|||PE sessions||Standard Deviation|Mean
2713068|NCT01151423|Secondary|Number and Percentage of Subjects With Relapse of TTP|Number and percentage of subjects with relapse of TTP (defined as de novo TTP event that occurred later than 30 days after the last daily PE) was evaluated.|Later than 30 days after the last daily PE|ITT Population|||Participants|||Count of Participants
2713069|NCT01151423|Secondary|Number and Percentage of Subjects With Exacerbations of TTP|"Number and percentage of subjects with exacerbations of TTP (defined as recurrent thrombocytopenia following a confirmed platelet count response and requiring a re-initiation of daily PE treatment after ≥ 1 day but ≤ 30 days of end of daily PE treatment.~Time to first exacerbation of TTP was also examined as part of this end point analysis; the median time to first exacerbation could not be determined because of the small number of events."|Within 30 days of last day of initial daily PE|ITT Population|||Participants|||Count of Participants
2713070|NCT01151423|Secondary|Number and Percentage of Subjects With Complete Remission Following Initial Daily Plasma Exchange (PE)|Number and percentage of subjects with complete remission (defined as confirmed platelet count response and absence of exacerbation) following initial daily PE.|From the day of first study drug administration up to 30 days after first study drug administration|ITT Population|||Participants|||Count of Participants
2713071|NCT01151423|Primary|Time-to-response of Treatment Defined by a Confirmed Recovery of Platelets ≥ 150,000/µL|"Time-to-response, defined by the achievement of platelet count response, confirmed at 48 hours after the initial reporting of this response. Platelet response was defined as recovery of platelets ≥ 150,000/µL.~This response had to be confirmed at 48 hours after the initial reporting of platelet recovery ≥ 150,000/µL by a de novo measure of platelets ≥ 150,000/µL and lactate dehydrogenase (LDH) ≤ 2x upper limit of normal (ULN) (i.e., 'confirmed platelet response')."|From the day of first study drug administration up to 30 days after first study drug administration|ITT Population|||days||95% Confidence Interval|Median
2713259|NCT01149486|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713072|NCT01151410|Secondary|Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP).|Baseline to end of study (Week 52 or LOCF)|Full analysis set (FAS) included all randomized patients for this trial|||mmHg||Standard Error|Least Squares Mean
2713073|NCT01151410|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial|||mmHg||Standard Error|Least Squares Mean
2713074|NCT01151410|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial|||millimeter(s) of mercury (mmHg)||Standard Error|Least Squares Mean
2713075|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B|Redness scale of 0 to 4, where 0=None, and 4=Severe.|After 4 Weeks||||units on a scale|eyes|Standard Deviation|Mean
2713076|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.|After 4 Weeks||||units on a scale||Standard Error|Mean
2713077|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B|Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort|After 4 Weeks||||units on a scale||Standard Error|Mean
2713078|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks||||units on a scale||Standard Deviation|Mean
2713079|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B|Scale of 0 to 3, where 0=none and 3=severe staining.|After 4 Weeks||||units on a scale||Standard Deviation|Mean
2713080|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.|After 1 Week||||units on a scale||Standard Error|Mean
2713081|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A|Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort|After 1 Week||||units on a scale||Standard Error|Mean
2713082|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 Week||||units on a scale||Standard Deviation|Mean
2713083|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A|Standard scale of 0 to 3 where 0=None, 3=Severe staining|After 1 Week||||units on a scale|eyes|Standard Deviation|Mean
2713084|NCT01151371|Primary|Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks||||units on a scale||Standard Deviation|Mean
2713085|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A|Redness scale of 0 to 4, where 0=None, 4=Severe redness|After 1 Week||||Units on a scale|eyes|Standard Deviation|Mean
2713086|NCT01151371|Primary|Overall Comfort Narafilcon B v. Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 week||||units on a scale||Standard Deviation|Mean
2713087|NCT01151345|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2713088|NCT01151345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2713089|NCT01151345|Primary|Maximum Observed Plasma Concentration (Cmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Mean
2713263|NCT01149486|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713090|NCT01151345|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Mean
2713091|NCT01151345|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Mean
2713092|NCT01151280|Secondary|Time to Stent Occlusion|"Evidence of stent occlusion~stent occlusion was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data."|mean time from stent placement to stent removal for all 10 patients was 91.3 days.|"All participants were included for analysis.~1/10 subjects experienced stent occlusion at 68 days post stent placement. Mean time to event data was not calculated as only 1 stent occlusion occurred in 10 subjects."|||days|||Number
2713093|NCT01151280|Secondary|Re-intervention Occurrence|Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.|6 months post stent removal|All participants were included for analysis.|||participants|||Number
2713094|NCT01151280|Secondary|Effectiveness of Stent at 6 Months|"Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram.~Effectiveness is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent.~Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms."|From stent removal through 6 months post stent removal follow-up.|Effectiveness was assessed in 9 participants that had stricture resolution at the time of stent removal. 1 participant did not have resolution at removal and therefore could not be assessed in the post stent removal follow-up period.|||participants|||Number
2713095|NCT01151280|Secondary|Technical Success of Stent Placement|Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.|At stent placement (Day 1)|All participants were included for analysis.|||participants|||Number
2713096|NCT01151280|Secondary|Stent Removability|Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.|At 3 months (per protocol removal) or early removal|All participants were included for analysis.|||participants|||Number
2713097|NCT01151280|Secondary|Safety|"Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal.~Unit of measure will be the actual number of adverse events that occurred."|From enrollment through end of study.|All participants were included for analysis.|||adverse events|||Number
2713098|NCT01151280|Primary|Stricture Resolution at the Time of Stent Removal.|Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.|At 3 months (per protocol removal) or at early removal.|All participants were included for analysis.|||participants|||Number
2713099|NCT01151215|Secondary|Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone|Time from the date of randomization to the date of death (by any cause)|Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.|||Months|Participants|Inter-Quartile Range|Median
2713100|NCT01151215|Primary|Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.|Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.|||Months|Participants|Inter-Quartile Range|Median
2713101|NCT01151189|Secondary|QuantiFERON (QFN) Conversion Rate in MVA85A/AERAS-485 Recipients Compared to Control Subjects Without a Diagnosis of Tuberculosis During the Trial.||For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:~All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0 (QFT negative at baseline subgroup)."|||participants who converted|||Number
2713260|NCT01149486|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713102|NCT01151189|Secondary|Immunogenicity of MVA85A/AERAS-485 Compared to Placebo as Described by Flow Cytometric Intracellular Cytokine Staining (ICS) of CD4+ and CD8+ T Cells After Stimulation With a Peptide Pool of Mycobacterial Antigens.|The antigen-specific negative control-subtracted response for any cytokine (Interferon gamma [INFγ] , Interleukin 2 [IL2], Interleukin 17 [IL17] and tumor necrosis factor [TNF]).|7 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.|||Percent responding TCells||95% Confidence Interval|Median
2713103|NCT01151189|Secondary|Counts of Spot-forming Units After Stimulation With AG85A Peptide Pool.|Immunogenicity of MVA85A/AERAS-485 compared to placebo as described by the ex vivo interferon (IFN)-γ enzyme linked immunospot (ELISpot).|28 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.|||SFU - background/10^6 PBMC||95% Confidence Interval|Median
2713104|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Participants.||Up tp 6 months post second vaccination|"Safety:~All randomized ART + subjects who received a dose of study vaccine, based on actual treatment received."|||copies/mL||Standard Deviation|Geometric Mean
2713105|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART - Participants||Up to 6 months post second vaccination.|"Safety:~All randomized ART - subjects who received a dose of study vaccine, based on actual treatment received."|||copies/mL||Standard Deviation|Geometric Mean
2713106|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Subjects||Up to 6 months post second vaccination.|"Safety:~All randomized ART positive subjects who received a dose of study vaccine, based on actual treatment received."|||cells/mm^3||Standard Deviation|Geometric Mean
2713107|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in Anti-retroviral Therapy Negative (ART -)Subjects||Up to 6 months post second vaccination.|"Safety:~All randomized ART negative subjects who received a dose of study vaccine, based on actual treatment received."|||cells/mm^3||Standard Deviation|Geometric Mean
2713108|NCT01151189|Secondary|Number of TB Cases|Efficacy of MVA85A/AERAS-485 in the prevention of TB disease compared to control subjects who received placebo in HIV-infected, African adult subjects without active TB disease.|For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:~All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0."|||participants with TB|||Number
2713109|NCT01151189|Primary|Percentage of Participants With Adverse Events|The primary objective of this study is to evaluate the safety of MVA85A/AERAS-485 compared to placebo in HIV-infected, African adult subjects without active TB disease.|Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.|"Safety:~All randomized subjects who received a dose of study vaccine, based on actual treatment received."|||percentage of participants with an AE|||Number
2713110|NCT01151137|Other Pre-specified|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|Safety population: all randomized and treated participants. Participants were considered according to the treatment actually received. Consequently the participant randomized to the placebo group who received Dronedarone was included in the Dronedarone group.|||participants|||Number
2713111|NCT01151137|Other Pre-specified|Overview of Cardiovascular Events||From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||participants|||Number
2713112|NCT01151137|Secondary|Time to Cardiovascular Death (Cumulative Incidence Function)|"Time to cardiovascular death was defined as the time from randomization to the death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||proportion of participants||95% Confidence Interval|Number
2713113|NCT01151137|Secondary|Deaths|Deaths were classified according to the primary cause of death.|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||participants|||Number
2713114|NCT01151137|Primary|Time to Second Co-primary Outcome (Cumulative Incidence Function)|"Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||proportion of participants||95% Confidence Interval|Number
2713115|NCT01151137|Primary|Time to First Co-primary Outcome (Cumulative Incidence Function)|"Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||proportion of participants||95% Confidence Interval|Number
2713128|NCT01151020|Primary|Patients With Device Failures|Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.|12 months||||participants|||Number
2713261|NCT01149486|Primary|Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2713116|NCT01151137|Primary|Overview of the Two Co-primary Outcomes|"First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.~Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.~Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population: All randomized participants considered in the treatment group to which they were randomized regardless of the treatment they actually received|||participants|||Number
2713117|NCT01151098|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.|28 weeks|The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase.|||participants|||Number
2713118|NCT01151085|Secondary|Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.|Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2713119|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2713120|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks||||participants|||Number
2713121|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2713122|NCT01151085|Secondary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|16 weeks|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.|||events|||Number
2713123|NCT01151085|Primary|Number of Participants That Responded to Voriconazole Treatment.|The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2713124|NCT01151085|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
2713125|NCT01151046|Secondary|Overall Survival|To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, over approximately 2 years||||weeks||95% Confidence Interval|Median
2713126|NCT01151046|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Exemestane in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RT-PCR for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to exemestane can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 79.1 weeks|Patients with available tissue for RT-PCR analysis|||months PFS||95% Confidence Interval|Median
2713127|NCT01151046|Primary|Progression Free Survival (PFS)|"To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 79.1 weeks||||weeks||95% Confidence Interval|Median
2713170|NCT01150461|Secondary|Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year||||Percentage change in LV mass||Inter-Quartile Range|Mean
2713129|NCT01151020|Primary|Patients With Major Adverse Events (MAE)|"Major adverse event is defined as:~All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room."|30 days|1 patient had a stroke and required ventilation >72 hours/reintubation.|||participants|||Number
2713130|NCT01150981|Secondary|Serum Adiponectin|Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment|8 weeks||||ng/ml||Standard Error|Mean
2713131|NCT01150981|Primary|Adipose Tissue Capillary Sprout Formation|Adipose tissue collected at 8 weeks was cut into ~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.|8 weeks|The number of subjects was based on the power of calculations in being able to demonstrate a difference from baseline in fat tissue microvasculature, change in HOMA2 and serum adiponectin after 6 weeks of rosiglitazone intake in all groups.|||number of capillary sprouts||Standard Deviation|Mean
2713132|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period|New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
2713133|NCT01150903|Secondary|Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
2713134|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period|New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
2713135|NCT01150903|Primary|Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
2713136|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 366 up to Day 457 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.|||Percentage of participants|||Number
2713137|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.|||Percentage of participants|||Number
2713138|NCT01150903|Primary|Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91|New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 0 to Day 91 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.|||Percentage of participants|||Number
2713139|NCT01150903|Primary|Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription|Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.|||Percentage of participants|||Number
2713140|NCT01150760|Primary|Intensive Care Unit Length of Stay||Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Days||Standard Deviation|Mean
2713141|NCT01150760|Primary|Percentage of Patients Discharged to Various Locations|Location of discharge for patients who were admitted to the hospital for their bowel resection from home|Hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of participants|||Number
2713142|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 30 Days of Discharge||Between 0-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of participants|||Number
2713143|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge||Between 16-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of participants|||Number
2713144|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 15 Days of Discharge||Within 15 days of discharge from hospitalization for bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of partcipants|||Number
2713145|NCT01150760|Primary|Percentage of Patients With In-hospital Other Morbidity|Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713146|NCT01150760|Primary|Percentage of Patients With In-hospital Thromboembolic Morbidity|Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713147|NCT01150760|Primary|Percentage of Patients With In-hospital Infection Morbidity|Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713148|NCT01150760|Secondary|Postoperative Length of Hospital Stay|Calendar day of discharge - calendar day of surgery = postoperative length of stay|Measured from the day after bowel resection to the day of hospital discharge|Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan [for alvimopan cohort] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)|||Days||Standard Deviation|Mean
2713149|NCT01150760|Primary|Percentage of Patients With In-hospital Pulmonary Morbidity|Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713171|NCT01150461|Primary|Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year||||Percentage change in fibrotic myocardium||Standard Deviation|Mean
2713150|NCT01150760|Primary|Percentage of Patients With In-hospital Cerebrovascular Morbidity|Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713151|NCT01150760|Primary|Percentage of Patients With In-hospital Cardiovascular Morbidity|Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications).|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713152|NCT01150760|Primary|Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity|GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713153|NCT01150760|Primary|Percentage of Patients Who Died|All-cause|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
2713154|NCT01150500|Secondary|Clinical Endpoints|Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis|5 Years|||||||
2713155|NCT01150500|Secondary|Percent Diameter Stenosis|The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).|Baseline and 9 month|67 lesions in 65 patients were analyzed.|||% DS (diameter stenosis)||Standard Deviation|Mean
2713156|NCT01150500|Secondary|Minimum Luminal Diameter|The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.|9 month|67 lesions in 65 patient were analyzed.|||mm||Standard Deviation|Mean
2713157|NCT01150500|Secondary|Binary Angiographic Restenosis|Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.|Baseline and 9 month|67 lesions in 65 patients were analysed.|||percentage of patient|||Number
2713158|NCT01150500|Secondary|Late Lumen Loss|Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.|Baseline and 9 months|67 Lesions in 65 patients are analysed.|||mm||Standard Deviation|Mean
2713159|NCT01150500|Secondary|MACE (Major Adverse Cardiac Event)|Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.|Baseline and 9 month|65 patients were analyzed as ITT population|||percentage of patient|||Number
2713160|NCT01150500|Primary|Target Lesion Failure(TLF)|Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)|9 month|All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population.|||percentage of TLF|||Number
2713161|NCT01150474|Secondary|Satisfaction With Pain Relief|"Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being very dissatisfied, and 10 being very satisfied."|Approximately 24 hours following surgery||||units on a scale||Standard Deviation|Mean
2713162|NCT01150474|Secondary|Number of Subjects Who Used Antiemetic Rescue Medications||First 24 hours after surgery||||participants|||Number
2713163|NCT01150474|Secondary|Number of Times Antiemetic Rescue Medication Was Used||First 24 hours after surgery||||number of times antiemetics used||Standard Deviation|Mean
2713164|NCT01150474|Secondary|Number of Subjects With Vomiting|This information was taken from the medical record.|Within 20 hours of surgery||||participants|||Number
2713165|NCT01150474|Secondary|Number of Subjects With Nausea|This information was taken from the medical record.|Approximately 12 hours after surgery||||participants|||Number
2713166|NCT01150474|Secondary|Narcotic Rescue Medication|Use of all ancillary narcotic medications was taken from the medical record.|For 24 hours following surgery||||mg IV morphine equivalents||Standard Deviation|Mean
2713167|NCT01150474|Secondary|Pain at Hour 20|"Pain at 20 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|20 hours after surgery.||||units on a scale||Standard Deviation|Mean
2713168|NCT01150474|Secondary|Pain at Hour 12|"Pain at 12 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|12 hours after surgery.||||units on a scale||Standard Deviation|Mean
2713169|NCT01150474|Primary|Pain at Hour 4|"Pain at 4 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|4 hours following surgery||||units on a scale||Standard Deviation|Mean
2713173|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non-dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."|||mmHg||Standard Deviation|Mean
2713174|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm - 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am -6pm) ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."|||mmHg||Standard Deviation|Mean
2713175|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)|ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.|Baseline to Week 4|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mmHg||Standard Error|Least Squares Mean
2713176|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)|Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24-hour monitoring period for removal of device and BP assessments. The ABPM device was pre-set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 - 24 hours.|Baseline to endpoint (Week 4 or LOCF)|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here 'Number of participants analyzed' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
2713177|NCT01150357|Secondary|Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)|Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."|||Percentage of participants|||Number
2713178|NCT01150357|Secondary|Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3*(SBP-DBP).|Week 4 to endpoint (Week 8 or LOCF)|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mmHg||Standard Error|Mean
2713179|NCT01150357|Secondary|Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP-DBP).|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for MAP at Week 4 (or LOCF) for each arm, respectively."|||mmHg||Standard Error|Mean
2713180|NCT01150357|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 8 or LOCF for each arm, respectively."|||mmHg||Standard Error|Mean
2713181|NCT01150357|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 4 or LOCF for each arm, respectively."|||mmHg||Standard Error|Mean
2713182|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|From Week 4 to Week 8|The analysis was performed on the SAF which included all participants who received at least one dose of study treatment during phase 2 (week 4 to week 8).|||participants|||Number
2713183|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Baseline up to Week 4|The analysis was performed on the Safety Sets (SAF), SAF is all participants who received at least one dose of study treatment during phase 1 (baseline to week 4)|||participants|||Number
2713184|NCT01150357|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|The primary analysis was performed on the FAS population.|||mmHg||Standard Error|Mean
2713185|NCT01150357|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))|"The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post­baseline assessment for primary efficacy. Here, Number of participants analyzed signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively."|||millimeter(s) of mercury (mmHg)||Standard Error|Mean
2713186|NCT01150123|Secondary|Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2|GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.|Day 1 and Day 721|Analysis was done on secondary persistence PPS.|||Ratios||95% Confidence Interval|Geometric Mean
2713187|NCT01150123|Secondary|Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1|GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.|Day 1 and Day 721|Analysis was done on secondary persistence PPS|||Ratios||95% Confidence Interval|Geometric Mean
2713188|NCT01150123|Secondary|Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2|The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.|Day 1 and Day 721|Analysis was done on secondary persistence PPS.|||µg/mL||95% Confidence Interval|Geometric Mean
2713189|NCT01150123|Secondary|Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1|The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.|Day 1 and Day 721|Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
2713190|NCT01150123|Secondary|Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2|Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.|Day 1 through Day 721|Analysis was done on Unsolicited Safety Set.|||participants|||Number
2713191|NCT01150123|Secondary|Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1|Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.|Day 1 through Day 721|Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.|||participants|||Number
2713192|NCT01150123|Secondary|Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2|Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.|Day 1 to Day 7|Analysis was done on Solicited Safety Set|||participants|||Number
2713193|NCT01150123|Primary|Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361|GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.|Day 1 and day 361|Analysis was done on Co-Primary PPS.|||Ratios||95% Confidence Interval|Geometric Mean
2713194|NCT01150123|Primary|Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361|Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.|Day 1 and Day 361|Analysis was done on Co-Primary PPS|||µg/mL||95% Confidence Interval|Geometric Mean
2713195|NCT01150123|Primary|Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2|The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.|Day 1 and Day 361|Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis|||percentage of subjects|||Number
2713196|NCT01150123|Primary|Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype|Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.|Day 61/Day 1|Analysis was done on Primary PPS.|||Ratios||95% Confidence Interval|Geometric Mean
2713197|NCT01150123|Secondary|Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1|Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.|Day 1 to Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.|||participants|||Number
2713198|NCT01150123|Primary|Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61|Serotype-specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.|Day 1 and Day 61|Analysis was done on Primary PPS|||µg/mL||95% Confidence Interval|Geometric Mean
2713199|NCT01150123|Primary|Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1|The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.|Day 1 and Day 61|Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.|||percentage of subjects|||Number
2713200|NCT01150097|Primary|Change in Renal Function|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.|from months 24 to 36|The analysis population included extension participants who had both post-extension baseline and month 36 values only.|||mL/min/1.73m^2||Standard Deviation|Mean
2713201|NCT01150097|Secondary|Incidence Rate of tBPAR|The number of participants who had a tBPAR was analyzed. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection.|from months 24 - 36|All extension participants|||Participants|||Number
2713202|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 - 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group|||Participants|||Number
2713203|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants|||Participants|||Number
2713204|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 to 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group|||Participants|||Number
2713205|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants|||Participants|||Number
2713206|NCT01149876|Secondary|Change in Rhytides|"Secondary outcome measures will be change in rhytides of baseline compared to week 16.~Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines."|baseline to week 16||||units on a scale||Standard Deviation|Mean
2713207|NCT01149876|Primary|Change in Hyperpigmentation of the Face|"Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16.~Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation."|baseline to 16 weeks||||units on a scale||Standard Deviation|Mean
2713208|NCT01149863|Secondary|Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs||Within the first 5 days following plerixafor initiation||||Participants|||Number
2713209|NCT01149863|Primary|Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.||Within the first 5 days following plerixafor initiation||||Participants|||Number
2713210|NCT01149785|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (Cmax).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2713211|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC(0-∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) [MRAUC(0-∞)].|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2713212|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2713213|NCT01149785|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2713214|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2713215|NCT01149785|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713216|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713217|NCT01149785|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
2713218|NCT01149785|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2713219|NCT01149785|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2713220|NCT01149785|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2713221|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2713222|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713223|NCT01149785|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713224|NCT01149772|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|Only patients randomized for heart failure was required to complete the assessment. There were fewer patients randomized for congestive heart failure (CHF) as compared to COPD.|||units on a scale||Standard Deviation|Mean
2713225|NCT01149772|Primary|Chronic Respiratory Questionnaire_Dyspnea|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment.|||units on a scale||Standard Deviation|Mean
2713226|NCT01149772|Primary|Chronic Respiratory Questionnaire_Mastery|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.|||units on a scale||Standard Deviation|Mean
2713227|NCT01149772|Primary|Chronic Respiratory Questionnaire_Fatigue|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.|||units on a scale||Standard Deviation|Mean
2713228|NCT01149772|Primary|Beck Anxiety Inventory (BAI)|The BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up||||units on a scale||Standard Deviation|Mean
2713229|NCT01149772|Primary|Patient Health Questionnaire -9 (PHQ-9)|The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up||||units on a scale||Standard Deviation|Mean
2713230|NCT01149759|Secondary|Change in Epidermal Thickness|Change in lesional skin epidermal thickness at week 12 compared to baseline|12 weeks|9 participants were included in this analysis from Rockefeller University, this is a change in the skin thickness at week 12 compared to baseline|||micrometer||Standard Deviation|Mean
2713231|NCT01149759|Primary|SCORAD Change Score|"SCORAD (SCORing Atopic Dermatitis) is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis (AD) as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe AD. For this outcome the SCORAD change score is computed as an absolute number which is comparing improvement in the SCORAD score of participants at week 12 compared to their SCORAD score at baseline."|12 weeks|9 were included in this analysis from Rockefeller University|||Change Score||Standard Deviation|Mean
2713232|NCT01149733|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf|Blood samples drawn over 60 hour period||||ng*h/mL||Standard Deviation|Mean
2713233|NCT01149733|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t|Blood samples drawn over 60 hour period||||ng*h/mL||Standard Deviation|Mean
2713234|NCT01149733|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax|Blood samples drawn over 60 hour period||||ng/mL||Standard Deviation|Mean
2713244|NCT01149655|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|"Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of yes to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury."|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of all participants who were randomized to period 3.|||percentage of participants|||Number
2713235|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).|The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 95 and 45.|||Units on a scale||Standard Deviation|Mean
2713236|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Negative Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.|||Units on a scale||Standard Deviation|Mean
2713237|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Positive Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.|||Units on a scale||Standard Deviation|Mean
2713238|NCT01149655|Other Pre-specified|Mean CGI-I Score at Endpoint.|Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved,;2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.|||Units on a scale||Standard Deviation|Mean
2713239|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in CGI-S Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.|||Units on a scale||Standard Deviation|Mean
2713240|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Total Score.|The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF (last observation carried forward) method was used to impute missing data. Week 1 had only 95 and 45 participants analyzed.|||Units on a scale||Standard Deviation|Mean
2713241|NCT01149655|Secondary|Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.|Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants who were randomized to period 3.|||percentage of participants|||Number
2713242|NCT01149655|Secondary|Percentage of Participants Who Had Achieved Remission.|Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants who were randomized to the double-blind treatment. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.|||percentage of participants|||Number
2713243|NCT01149655|Secondary|Percentage of Responders in Each Treatment Group.|Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants were randomized to period 3.|||percentage of participants|||Number
2713258|NCT01149486|Secondary|Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2713262|NCT01149486|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713245|NCT01149655|Primary|Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.|"The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of yes to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury."|Baseline to Week 52/End of Phase 3 visit.|For the primary analysis, participants that belonged to the ITT (intent to treat) data set were included in the analysis. Participants who were lost to follow-up or who were still in the study at the end of Week 52 were considered as censored on their date of last efficacy evaluation. The ITT data set comprised participants randomized to period 3.|||relapse rate(percentage of participants)|||Number
2713246|NCT01149616|Secondary|Postop Nausea|NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.|24 hours||||units on a scale||Inter-Quartile Range|Mean
2713247|NCT01149616|Secondary|Amount of Postop Narcotic Usage|Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge|24 hours||||number of tablets||Inter-Quartile Range|Median
2713248|NCT01149616|Primary|Post Operative VAS Pain Scale|Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.|24 hours||||units on a scale||Standard Deviation|Mean
2713249|NCT01149538|Secondary|Evoked Response Potential - Negative Component Latency|Evoked Response Potential - negative component latency data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)|||Milliseconds||Standard Deviation|Mean
2713250|NCT01149538|Secondary|Evoked Response Potentials Microvolts|Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)|||Mircovolts||Standard Deviation|Mean
2713251|NCT01149538|Secondary|Elicited Imitation Task Memory|The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.|Baseline, 6 months, and 9 months|Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).|||Slope||Standard Error|Mean
2713252|NCT01149538|Primary|Mullen Scales of Early Learning - Early Learning Composite|The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.|Baseline and 9 months|Including those with partial completion (drop-outs and lost-to-followup).|||units on a scale||Standard Deviation|Mean
2713253|NCT01149538|Primary|Side Effects of Choline Bitartrate|Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.|Baseline, 6 months, & 9 months|Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months|||participants|||Number
2713254|NCT01149512|Secondary|% of Excess Body Weight Loss|the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years|baseline to 1 year, baseline to 2 years, baseline to 3 years|3 not included the same reason as above.|||% of excessive weight loss||Standard Deviation|Mean
2713255|NCT01149512|Primary|Mean Percentage Total Body Weight Loss|the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years|baseline to 1 year, baseline to 2 years, baseline to 3 years|Three patients’ weight data were not included in the weight loss analysis owing to early removal of band (n = 1) and complication or pregnancy affecting weight (n = 2) before 1-year follow-up. 79 patients reached 2 year follow up time point and 38 patients reached 3 year follow up time point.|||% of total body weight loss||Standard Deviation|Mean
2713256|NCT01149486|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713257|NCT01149486|Secondary|AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713457|NCT01148836|Primary|Left Ventricular End Diastolic Volume|Amount of blood in ventricle at end of diastole|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||ml||Standard Deviation|Mean
2713265|NCT01149473|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713266|NCT01149473|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713267|NCT01149473|Primary|Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2713268|NCT01149473|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713269|NCT01149473|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2713270|NCT01149473|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2713271|NCT01149460|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2713272|NCT01149460|Secondary|AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2713273|NCT01149460|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2713274|NCT01149460|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2713275|NCT01149460|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2713276|NCT01149460|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2713277|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years||||Participants|||Number
2713278|NCT01149434|Primary|Tumor Response in the Ovarian Cancer Cohort|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors|2 years|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. The number of patients enrolled on the remaining cohorts were not included in this analysis.|||Participants|||Number
2713279|NCT01149434|Primary|Progression Free-Survival in the Ovarian Cancer Cohort|progression-free survival at 2 months. We define progression as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), to detect a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 months|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. Patients enrolled on the remaining cohorts were excluded in this analysis. Results were calculated using Kaplan-Meier product limit methods.|||percentage of participants||95% Confidence Interval|Number
2713280|NCT01149434|Secondary|Tumor Response|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||participants|||Number
2713281|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years||||participants|||Number
2713282|NCT01149434|Primary|Effect of RAD001 on Pharmacokinetics AUC(0-inf) of JI-101|Determine the mean percent change that RAD001 has on the peak concentration as determined by calculating the AUC (0-inf) of JI101 in the presence and absence of RAD001|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 8 for RAD001 + JI101 and Cycle 1 Day 15 for JI-101 alone||||percentage change||Full Range|Mean
2713283|NCT01149434|Primary|Effect of JI 101 on Pharmacokinetics Area Under Curve (AUC) (0-inf) of RAD001|Determine the mean percent change that JI-101 has on the peak concentration as determined by calculating the AUC (0-inf) of RAD001 in the presence and absence of JI-101|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 1 for RAD001 alone and Cycle 1 Day 8 for RAD001 + JI-101||||percentage change||Full Range|Mean
2713458|NCT01148810|Secondary|Serum Levels of Muscle Enzymes||Baseline, Week 12|PD set in all disease types|||U/L||Standard Deviation|Mean
2713719|NCT01147471|Secondary|Pulmonary Function|Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits||||||
2713284|NCT01149421|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4, 8, 12, 16, and 26 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.|||nanograms*hour per liter (ng*h/L)||Standard Deviation|Mean
2713285|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Body Weight|Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data.|||kilogram (kg)||Standard Error|Least Squares Mean
2713286|NCT01149421|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||events per participant per 30 days||Standard Deviation|Mean
2713287|NCT01149421|Secondary|Anti-LY2189265 Antibodies|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized.|Baseline, 16, 26, and 30 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable anti-drug (LY2189265) antibodies (ADA) data.|||participants|||Number
2713288|NCT01149421|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||participants|||Number
2713289|NCT01149421|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||events|||Number
2713290|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Fridericia-corrected QT (QTcF) or PR interval change from baseline data.|||milliseconds (msec)||Standard Error|Least Squares Mean
2713291|NCT01149421|Secondary|Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)||Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable High-Sensitivity C-Reactive Protein (hs-CRP) data.|||milligram per liter (mg/L)||Standard Deviation|Mean
2713292|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Serum Calcitonin||Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable serum calcitonin data.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2713293|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pancreatic enzyme data.|||units per liter||Inter-Quartile Range|Median
2713294|NCT01149421|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||participants|||Number
2713295|NCT01149421|Secondary|Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with Chi-squared test/Fisher's exact test.|Baseline and 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.|||percentage of participants|||Number
2713720|NCT01147471|Secondary|Quality of Life|Rand 36 health survey.|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits||||||
2713296|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2713297|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)|Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2713298|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)|Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713299|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure|Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713300|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)|Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2713301|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)|Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713302|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)|Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713325|NCT01149369|Secondary|Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The small number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713303|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)|Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713304|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure|Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713305|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)|Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2713306|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)|Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.|||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
2713307|NCT01149421|Secondary|Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713308|NCT01149421|Primary|Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2713309|NCT01149369|Secondary|Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||average power in frequency region, %||Standard Deviation|Mean
2713474|NCT01148745|Secondary|Transferrin Saturation (TSAT)|Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100|7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.||||percent||Full Range|Median
2713310|NCT01149369|Secondary|Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week followup visit.|||average power in frequency region, %||Standard Deviation|Mean
2713311|NCT01149369|Secondary|Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||average power in frequency region, %||Standard Deviation|Mean
2713312|NCT01149369|Secondary|Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||average power in frequency region, %||Standard Deviation|Mean
2713313|NCT01149369|Secondary|Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||average power in frequency region, %||Standard Deviation|Mean
2713314|NCT01149369|Secondary|Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).|4 weeks||||average power in frequency region, %||Standard Deviation|Mean
2713315|NCT01149369|Secondary|Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||average power in frequency region, %||Standard Deviation|Mean
2713326|NCT01149369|Secondary|Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 week|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713721|NCT01147471|Primary|Mortality|Number of participants who died during any hospital stay.|Measured any time during hospital stay (approx 30 days)||||participants|||Number
2713316|NCT01149369|Secondary|Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement|Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||average power in frequency region, %||Standard Deviation|Mean
2713317|NCT01149369|Secondary|Satiety Test, Volume Consumed|The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mL||Inter-Quartile Range|Median
2713318|NCT01149369|Secondary|State-Trait Anxiety Inventory (STAI): Trait Anxiety Score|The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713319|NCT01149369|Secondary|State-Trait Anxiety Inventory (STAI): State Anxiety Score|The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713320|NCT01149369|Secondary|Beck Depression Inventory (BDI) Score|The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713321|NCT01149369|Secondary|Brief Pain Inventory: Interference Score|The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713322|NCT01149369|Secondary|Brief Pain Inventory: Severity Score|The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713323|NCT01149369|Secondary|Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713324|NCT01149369|Secondary|Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713492|NCT01148511|Secondary|Change in Central Retinal Thickness From Baseline to Month 12|Retinal thickness was measured using Optical Coherence Tomography (OCT).|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||µm||Full Range|Median
2713327|NCT01149369|Secondary|Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713328|NCT01149369|Secondary|Gastrointestinal Symptom Rating Scale (GSRS): Total Score|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713329|NCT01149369|Secondary|PAGI-SYM Severity Index: Diarrhea Severity|The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713330|NCT01149369|Secondary|PAGI-SYM Severity Index: Constipation Severity|The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713331|NCT01149369|Secondary|PAGI-SYM Severity: Bitter Taste Severity|The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713332|NCT01149369|Secondary|PAGI-SYM Severity Index: Regurgitation When Lying Down Severity|The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713333|NCT01149369|Secondary|PAGI-SYM Severity Index: Regurgitation During the Day Severity|The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713334|NCT01149369|Secondary|PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity|The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713335|NCT01149369|Secondary|PAGI-SYM Severity Index: Chest Discomfort During the Day Severity|The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713493|NCT01148511|Secondary|Follow-up Duration|Follow-up duration was defined as the number of days from Baseline to study discontinuation.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Days||Full Range|Mean
2713336|NCT01149369|Secondary|PAGI-SYM Severity Index: Heartburn When Lying Down Severity|The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713337|NCT01149369|Secondary|PAGI-SYM Severity Index: Heartburn During the Day Severity|The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713338|NCT01149369|Secondary|PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity|The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713339|NCT01149369|Secondary|PAGI-SYM Severity Index: Lower Abdominal Pain Severity|The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713340|NCT01149369|Secondary|PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity|The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713341|NCT01149369|Secondary|PAGI-SYM Severity Index: Upper Abdominal Pain Severity|The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713342|NCT01149369|Secondary|PAGI-SYM Severity Index: Stomach Distention Severity|The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713343|NCT01149369|Secondary|PAGI-SYM Severity Index: Bloating Severity|The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713344|NCT01149369|Secondary|PAGI-SYM Severity Index: Loss of Appetite Severity|PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713385|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||number of episodes||Standard Deviation|Mean
2713345|NCT01149369|Secondary|PAGI-SYM Severity Index: Excessive Fullness Severity|PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713346|NCT01149369|Secondary|PAGI-SYM Severity Index: Unable to Finish Meal Severity|PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713347|NCT01149369|Secondary|PAGI-SYM Severity Index: Stomach Fullness Severity|PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713348|NCT01149369|Secondary|PAGI-SYM Severity Index: Retching Severity|The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713349|NCT01149369|Secondary|PAGI-SYM Severity Index: Vomiting Severity|The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713350|NCT01149369|Secondary|PAGI-SYM Severity Index: Nausea Severity|The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713351|NCT01149369|Secondary|PAGI-SYM Severity Index: GERD Subscore|PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713352|NCT01149369|Secondary|PAGI-SYM Severity Index: Upper Abdominal Pain Subscore|The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713353|NCT01149369|Secondary|PAGI-SYM Severity Index: Bloating Subscore|The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713386|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||number of episodes||Standard Deviation|Mean
2713354|NCT01149369|Secondary|PAGI-SYM Severity Index: Fullness/Early Satiety Subscore|The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713355|NCT01149369|Secondary|PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore|The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713356|NCT01149369|Secondary|PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score|PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713357|NCT01149369|Secondary|Creatinine|Change from baseline in creatinine (mg/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mg/dL||Standard Deviation|Mean
2713358|NCT01149369|Secondary|Magnesium|Change from baseline in magnesium (mg/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mg/dL||Standard Deviation|Mean
2713359|NCT01149369|Secondary|Blood Urea Nitrogen (BUN)|Change from baseline in blood urea nitrogen (BUN) (mg/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mg/dL||Standard Deviation|Mean
2713360|NCT01149369|Secondary|Calcium|Change from baseline in calcium (mg/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mg/dL||Standard Deviation|Mean
2713361|NCT01149369|Secondary|Potassium|Change from baseline in potassium (mEq/L)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mEq/L||Standard Deviation|Mean
2713362|NCT01149369|Secondary|Sodium|Change from baseline in sodium (mEq/L)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mEq/L||Standard Deviation|Mean
2713363|NCT01149369|Secondary|Chloride|Change from baseline in chloride (mEq/L)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mEq/L||Standard Deviation|Mean
2713364|NCT01149369|Secondary|Carbon Dioxide|Change from baseline in carbon dioxide (mEg/L)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mEq/L||Standard Deviation|Mean
2713365|NCT01149369|Secondary|Platelet Count|Change from baseline in platelet count|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||x10^3 cells/microliter||Standard Deviation|Mean
2713366|NCT01149369|Secondary|Red Blood Cell Count (RBC)|Change from baseline in red blood cell count (RBC)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||x10^6 cells/microliter||Standard Deviation|Mean
2713367|NCT01149369|Secondary|White Blood Cell Count (WBC)|Change from baseline in white blood cell count (WBC)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||x10^9 cells/L||Standard Deviation|Mean
2713368|NCT01149369|Secondary|Hematocrit|Change from baseline in hematocrit|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||percentage RBCs||Standard Deviation|Mean
2713369|NCT01149369|Secondary|Hemoglobin|Change from baseline in hemoglobin (g/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||g/dL||Standard Deviation|Mean
2713370|NCT01149369|Secondary|Liver Enzymes and Proteins: Albumin|Change from baseline in albumin (g/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||g/dL||Standard Deviation|Mean
2713371|NCT01149369|Secondary|Glucose|Change from baseline in glucose (mg/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||mg/dL||Standard Deviation|Mean
2713372|NCT01149369|Secondary|Hemoglobin A1c (HbA1c)|Change from baseline in hemoglobin A1c (HbA1c) (%)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2713373|NCT01149369|Secondary|Liver Enzymes and Proteins: Total Protein|Change from baseline in total protein (g/dL)|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||g/dL||Standard Deviation|Mean
2713374|NCT01149369|Secondary|Liver Enzymes and Proteins: Aspartate Aminotransferase (AST)|Change from baseline in aspartate aminotransferase (AST), U/L|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||U/L||Standard Deviation|Mean
2713375|NCT01149369|Secondary|Liver Enzymes and Proteins: Alanine Aminotransferase (ALT)|Change from baseline in serum alanine aminotransferase (ALT), U/L|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||U/L||Standard Deviation|Mean
2713376|NCT01149369|Secondary|Clinical Global Patient Impression Score (Patient-rated)|The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713377|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713378|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713379|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713380|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713381|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713382|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713383|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713384|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score|The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||units on a scale||Standard Deviation|Mean
2713387|NCT01149369|Secondary|Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)|Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.|4 weeks|The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.|||hours of nausea||Standard Deviation|Mean
2713388|NCT01149369|Primary|Number of Participants With Improvement in Nausea|The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm.|4 weeks||||participants|||Number
2713389|NCT01149343|Secondary|Duration of Response for Patients With CR, PR and SD or SD/PR Status (Phase II)|This analysis was not performed following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG/anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.|Up to concluding visit, at Week 199|This analysis was not performed.||||||
2713390|NCT01149343|Secondary|Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)|Time to treatment failure (TTF) was defined as the time from first administration of study product until the date of the last administration of the product, irrespective of the reason for study treatment discontinuation. Progression-free survival (PFS) was defined as the time from first adminsitration of study product until the date of either disease progression or death (for whatever reason), whichever comes first. Overall survival (OS) was defined as the time from first administration of study product until death.|Up to concluding visit, at Week 199|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Months||95% Confidence Interval|Median
2713391|NCT01149343|Secondary|Anti-Cytosine Phosphate Guanosine Oligodeoxynucleotide (CpG) Humoral Response (Phase I & II)|Analysis of immunogenicity for anti-CpG antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.|At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit|This analysis was not performed.||||||
2713392|NCT01149343|Secondary|Anti-Protein D Humoral Response (Phase I & II)|Analysis of immunogenicity for anti-PD antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.|At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit|This analysis was not performed.||||||
2713393|NCT01149343|Secondary|Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)|"Tumor response was assessed by the RECIST criteria, where SD for target lesions refers to neither enough shrinkage to qualify for CR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more nom-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these. Mixed response is defined as at least 30% decrease in the LD occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise SD or PD status of the LD of target lesions were classified as SD with target lesion regression or PD with target lesion regression, respectively. New lesion(s) in otherwise PR status of the LD of target lesions were PR with new lesion."|At 30 days after the last treatment administration for each patient (Week 199)|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713417|NCT01149096|Primary|10-year Mortality Rate in Marrow Donors|The Kaplan-Meier method will be used to estimate overall survival probabilities in standard BM and G-BM donors.|Up to 10 years post bone marrow harvest|Data were not collected as no patients were followed to 10 years.||||||
2713418|NCT01149096|Primary|Percentage of Participants With Grade 3 or 4 Toxicities|Estimate the percentage of patients having non-fatal complications of Grade 3 other than pain (consider Grade 4 for pain only), or any of Grade 4 in standard BM and G-CSF stimulated-bone marrow (G-BM) donors. Modified Toxicity Criteria and Pain Assessment was used with higher grades corresponding to more severe AEs.|Up to 1 year after donation|All patients included in analysis. No incidence of grades 3 or 4 toxicities.|||percentage of patients|||Number
2713394|NCT01149343|Secondary|Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)|Tumor response was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST), where stable disease for target lesions refers to neither enough shrinkage to qualify for complete response nor sufficient increase to qualify for progressive disease taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more non-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these.|At 30 days after the last treatment administration for each patient (Week 199)|The analysis was performed on the Total Vaccinated Cohort, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713395|NCT01149343|Secondary|Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)|A seropositive patient was a patient whose anti-PRAME antibody concentration was greater than or equal to (≥) the assay cut-off value of 12 ELISA units per milliliter (EL.U/mL). A seronegative patient was defined as a patient whose pre-treatment antibody concentration was below (<) the cut-off value. An anti-PRAME antibody responder was defined as: For a seronegative patient: a post-treatment antibody concentration ≥ the cut-off value; For a seropositive patient: a post-treatment antibody concentration ≥ twice the pre-treatment antibody concentration.|At Weeks 0, 4, 8, 10, 12, 29, 51, 75, 99, 123, 147 and conclusion visit at 30 days post last treatment administration (Week 199) for each patient|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713396|NCT01149343|Secondary|Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)|Cellular response was defined as: Geometric Mean Response (GMR) above the 2.68 cut-off value and at least a four-fold increase of PRAME- specific Cluster of Differentiation (CD) 4/8 T-cells. Considering that 2 studies failed to demonstrate clinical efficacy of recombinant protein based cancer vaccines, GSK decided in 2014 to stop the development and to stop recruitment in all the ongoing clinical studies. The decision was made to end the study (i.e., stopping patient enrollment, follow-ups, sample collection and analysis of samples for research purposes). Patients still on treatment at the time of the protocol amendment were offered to continue the administration of the study treatment until the last dose or until recurrence, whichever came first, or until the patient or the investigator decided to stop the study treatment. No further active protocol visit/contact was performed except for the concluding visit at Week 199, 30 days after the last treatment administration.|Up to Data Lock Point at Week 8|The analysis was performed on the Phase 1 subjects with available results up to Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Percentage of patients||95% Confidence Interval|Number
2713397|NCT01149343|Secondary|Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [NEUC/D], [PLA/D] and [WBC/D] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713398|NCT01149343|Secondary|Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [LYMC/D] and [LYMC/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713399|NCT01149343|Secondary|Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [Hgb/I] and [HYP] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713400|NCT01149343|Secondary|Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [CRE/I] and [GGT/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713401|NCT01149343|Secondary|Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [AN], [AST/I] and [CRE/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713402|NCT01149343|Secondary|Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [ALT/I] and [APH/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713403|NCT01149343|Secondary|Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Unknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [APTTP] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713404|NCT01149343|Secondary|Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). SAEs were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713419|NCT01149096|Primary|Percentage of Participants With Grade 1 or 2 Toxicities|Estimate the percentage of patients having non-fatal complications of CTCAE Grades 1 or 2 in standard BM and G-CSF stimulated-bone marrow (G-BM) donors.|Up to 1 year after donation|Modified Toxicity Criteria and Pain Assessment was used with higher grades corresponding to more severe AEs.|||percentage of patients|||Number
2713420|NCT01149096|Primary|Percentage of Participants Who Experienced Death in G-CSF Stimulated-bone Marrow (G-BM) Donors|The Kaplan-Meier method will be used to estimate the cumulative incidence of death event in G-BM donors only.|Up to 1 year after donation|Analysis conducted for stimulated-bone marrow (G-BM) donors only, therefore, no report on the control arm (Conventional bone marrow transplant).|||Percentage of patients|||Number
2713494|NCT01148511|Secondary|Number of Visits||Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Visits||Full Range|Median
2713405|NCT01149343|Secondary|Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). Adverse Events were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713406|NCT01149343|Primary|Number of Patients With Best Overall Response to Study Treatment (Phase II)|The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). In general the patient's best response assignment depended on the achievement of both measurement and confirmation criteria. The best overall response includes the complete response (CR) defined as disappearance of all targeted/non-targeted lesions and partial response (PR) defined as at least 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD and persistence of one or more non-targeted lesion(s).|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713407|NCT01149343|Primary|Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)|A seronegative/seropositive patient for anti-PRAME antibodies was a patient with antibody concentration lower (<)/ higher than or equal to (≥) cut-off level. Humoral immune response was defined as a) if baseline concentration < cut-off level: post treatment concentration ≥ cut-off level, or b) if baseline concentration ≥ cut-off level: post treatment concentration at least twice the baseline value. Cut-off values for seropositivity (by enzyme-linked immunosorbent assay [ELISA]) were 12 ELISA Units per milliliter (EL.U/mL).|After the administration of dose 4, at Week 8|The analysis was performed on Phase 1 subjects with available results at Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Percentage of patients||95% Confidence Interval|Number
2713408|NCT01149343|Primary|Number of Patients With Dose-limiting Toxicity (Phase I)|"The dose-limiting toxicities (DLT) were defined as follows:~An Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly ASCI related grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) persisting for 48 hours despite therapy.~An ASCI related or possibly ASCI related grade 2 or higher allergic reaction occurring within 24 hours following the ASCI administration.~An ASCI related or possibly ASCI related decrease in renal function, with a creatinine clearance lower than (<) 40 milliliters per minute (mL/min).~An ASCI-related or possibly ASCI-related symptomatic and confirmed adrenal insufficiency. The grading used was defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 3 DLT = severe DLT. Related = DLT considered by investigator as possibly related to product administration."|During the study treatment (up to Year 4), for all patients|The analysis was performed on Phase 1 subjects from the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
2713409|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.~Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|3 Months|Not all participants completed 3 month follow up neurocognitive testing.|||Scores on a scale||Standard Deviation|Mean
2713410|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.~Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|Baseline||||scores on a scale||Standard Deviation|Mean
2713411|NCT01149096|Secondary|T Regulatory Cell Content|Median and interquartile range of the outcome measure in standard BM and G-BM donors.|Up to 1 year after donation|Data were not collected for this study.||||||
2713412|NCT01149096|Secondary|Dendritic Cell (DC) Populations|Median and interquartile range of the outcome measure in standard BM and G-BM donors.|Up to 1 year after donation|Data were not collected for this study.||||||
2713413|NCT01149096|Secondary|Th1 vs. Th2 Profile of T Cells|Proportion of donors with Th1-T cell profile in standard BM and G-BM donors.|Up to 1 year after donation|Data were not collected for this study.||||||
2713414|NCT01149096|Secondary|Absolute T Cell Numbers|Median and interquartile range of the outcome measure in standard BM and G-BM donors.|Up to 1 year after donation|Data were not collected for this study.||||||
2713415|NCT01149096|Primary|10-year Hematologic Cancer Rate|The Kaplan-Meier method will be used to estimate hematologic cancer probabilities in standard BM and G-BM donors.|Up to 10 years post bone marrow harvest|Data were not collected as no patients were followed to 10 years.||||||
2713416|NCT01149096|Primary|10-year Overall Cancer Incidence|The Kaplan-Meier method will be used to estimate overall cancer free probabilities in standard BM and G-BM donors.|Up to 10 years post bone marrow harvest|Data were not collected as no patients were followed to 10 years.||||||
2713421|NCT01149096|Primary|Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors|The Kaplan-Meier method will be used to estimate the cumulative incidence of short term adverse events defined by having any of the following events: 1) death due to a cause that is unknown or possibly related to G-CSF, 2) development of a malignancy, 3) development of a splenic rupture, or 4) development of a severe acute lung injury possibly related to GCSF therapy.|Up to 1 year after donation|Analysis conducted within G-BM donors only, therefore, no report for the control arm (Conventional bone marrow transplant).|||Percentage of patients|||Number
2713422|NCT01149057|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2713423|NCT01149057|Secondary|Participant Assessment of Pain (VAS)|"The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated No pain, and the right endpoint (100) indicated Unbearable pain. Higher score indicated higher pain."|Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||mm||Standard Deviation|Mean
2713424|NCT01149057|Secondary|Erythrocyte Sedimentation Rate||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||millimeter per hour||Standard Deviation|Mean
2713425|NCT01149057|Secondary|C-reactive Protein Level||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||milligram per deciliter||Standard Deviation|Mean
2713426|NCT01149057|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96||Baseline; Weeks 20, 44, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||gram per deciliter||Standard Deviation|Mean
2713427|NCT01149057|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96|ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||percentage of partcipants|||Number
2713428|NCT01149057|Secondary|Change From Baseline in SJC At Weeks 24, 48, 72, and 96|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.|||swollen joints||Standard Deviation|Mean
2713429|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
2713430|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
2713431|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
2713432|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|Per Protocol (PP) population: all participants who completed the study. Number of participants analyzed=participants with available data for this outcome. Here 'n' signifies the participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
2713433|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|ITT population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2713434|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|ITT population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2713435|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|ITT population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2713436|NCT01149057|Secondary|Change From Baseline in TJC At Weeks 24, 48, 72, and 96|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.|||tender joints||Standard Deviation|Mean
2713437|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96|CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2713438|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96|SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter [cm]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2713439|NCT01149057|Secondary|Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96|The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline <-1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline <-0.6 to greater than or equal to (≥) -1.2.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2713455|NCT01148836|Primary|Right Ventricle Myocardial Performance|Tei Index=(IRT+ICT)/ET, where IRT is isovolumic|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||ratio||Standard Deviation|Mean
2713456|NCT01148836|Primary|Right Ventricular Outflow|Velocity time interval|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||cm||Standard Deviation|Mean
2713440|NCT01149057|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score <2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2713441|NCT01149057|Secondary|Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score less than (<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity (visual analog scale [VAS]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||participants|||Number
2713442|NCT01149057|Secondary|Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study|BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation [SD] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.|Baseline, End of the study (up to Week 100)|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number of participants with available data for specified category.|||T-score||Standard Deviation|Mean
2713443|NCT01149057|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2713444|NCT01148979|Primary|Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks.|The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms.|Baseline to 4 weeks of treatment|All participants who completed all 4 weeks on both treatments (i.e., Placebo and Vyvanse) were included in the analysis.|||scores on a scale||Standard Deviation|Mean
2713445|NCT01148940|Primary|D-Dimer Levels Than in Black Women With Hb AA and White Women With Hb AA.|High D-Dimer levels are regarded as potentially prothrombotic markers and are often elevated in pregnancy and the postpartum. There are some data to suggest that sickle cell trait may also be prothrombotic.To investigate whether D-Dimer levels are higher in black peripartum women with SCT than in black or white pregnant/postpartum patients who have Hb AA, we will measure the D-Dimer, on a continuous scale, in the pregnant/postpartum population of each group. It is known that D-Dimer levels >1.0 mg/ml may be predictive of increased thrombotic risk. We will compare mean D-Dimer of Black SCT women, Black AA women and White AA women to determine whether higher D-Dimer levels, which may be a measure of hypercoagulability, are higher in women with SCT.|Date of delivery until 4-5 weeks postpartum.|did not recruit any women with sickle cell trait|||micrograms/ml||95% Confidence Interval|Mean
2713446|NCT01148862|Primary|The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.|Severity (Milligrams per Deciliter) of induced hypoglycemia (YSI < 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level|approximately 8 hours per induction experiment||||Milligrams per Deciliter||Standard Deviation|Mean
2713447|NCT01148862|Primary|The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.|Duration (minutes) of induced hypoglycemia (YSI < 70 mg/dL)|approximately 8 hours per induction experiment||||minutes||Standard Deviation|Mean
2713448|NCT01148836|Secondary|Red Blood Cell Distribution Width||before and after three months of CoQ||||percentage of sizes of red blood cells||Standard Deviation|Mean
2713449|NCT01148836|Secondary|Mean Corpuscular Hemoglobin||before and after three months of CoQ||||pg||Standard Deviation|Mean
2713450|NCT01148836|Secondary|Hematocrit||before and after three months of CoQ||||% of red blood cell||Standard Deviation|Mean
2713451|NCT01148836|Secondary|Hemoglobin||before and after three months of CoQ||||g/dl||Standard Deviation|Mean
2713452|NCT01148836|Secondary|Red Blood Cells||before and after three months of CoQ||||10^6 cells/µl||Standard Deviation|Mean
2713453|NCT01148836|Primary|Right Atrial Pressure||before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||mmHg||Standard Deviation|Mean
2713454|NCT01148836|Primary|Tricuspid Regurgitation Grade|Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||units on a scale||Standard Deviation|Mean
2713459|NCT01148810|Secondary|Health Assessment Questionnaire|Health Assessment Questionnaire (HAQ): This questionnaire is a patient reported outcome (PRO) which is self-administered by the patient. It is used to assess disability and comprises various categories related to usual daily activities. The patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The total score is derived from these sub-scores and ranges from 0 to 3 where higher HAQ indicates more disability.|Baseline, Week 12|PD set in all disease types|||Score on a scale||Standard Deviation|Mean
2713460|NCT01148810|Secondary|Manual Muscle Testing (MMT) - 8 Score|Manual Muscle Testing - 8 (MMT-8): Assessment of designated muscles manually by scoring each muscle from 0 to 10 where 0 is no strength and 10 is maximum strength. MMT- 8 includes 7 bilateral muscles (potential score 0-70 x 2) and one unilateral (axial) muscle (0-10 x1) so the total score ranges from 0 to 150 (maximum) where higher score indicates more strength.|Baseline, Week 12|PD set in all disease types|||scores on a scale||Standard Deviation|Mean
2713461|NCT01148810|Secondary|Patient Global Activity Assessment|Patient`s overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.|Baseline, Week 12|PD set in all disease types|||cm||Standard Deviation|Mean
2713462|NCT01148810|Secondary|Physician Global Activity Assessment|Physician`s overall assessment on a single 0-10 cm scale, where the higher score indicates higher disease activity.|Baseline, Week 12|PD set in all disease types|||cm||Standard Deviation|Mean
2713463|NCT01148810|Secondary|Myositis Disease (MD) Activity Scores|Myositis Disease Activity Scores. This is a combined tool that captures the physician's assessment of disease activity of various organ systems via the MYOSITIS INTENTION TO TREAT ACTIVITY INDEX (MITAX) and via the MYOSITIS DISEASE ACTIVITY ASSESSMENT VISUAL ANALOGUE SCALES (MYOACT) It rates the physician`s overall assessment of the ongoing current disease activity for various systems by drawing a vertical mark on the 10-cm line for each system according to the following scale: left end of line = no evidence of disease activity, midpoint of line = moderate disease activity, and right end of line = extreme or maximum disease activity.|Week 12|PD set in all disease types|||cm||Standard Deviation|Mean
2713464|NCT01148810|Secondary|Efficacy in Modifying Health-related Quality of Life Measured by SF-36|Short Form (36) Health Survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability.|12 weeks|All patients with evaluable (or complete) PD measurement and no major protocol deviations which impact on PD data were included in the PD analysis set.|||score on a scale||Standard Deviation|Mean
2713465|NCT01148810|Secondary|Summary of CRP Levels|Biomarkers reflecting efficacy in reducing systemic inflammatory components of the disease using serum markers such as C-reactive protein (CRP)|12 weeks|The Safety set included all patients who received at least one dose of study medication.|||mg/L||Standard Deviation|Mean
2713466|NCT01148810|Secondary|Mean Plasma Concentrations of BAF312||baseline to end of trial (day 196)|PK Analysis set in all disease types|||ng/ml||Standard Deviation|Mean
2713467|NCT01148810|Secondary|Number of Participants With a Change in Steroids Use After BAF312 Administration -Period 2||12 weeks|The Safety set included all patients who received at least one dose of study medication.|||Participants|||Count of Participants
2713468|NCT01148810|Primary|Number of Participants Who Responded to BAF312|Preliminary clinical efficacy of BAF312 in patients with Polymyositis and dermatomyositis (PM/DM) using the International Myositis Assessment and Clinical Studies Group (IMACS) core set measures (including manual muscle testing, Physician's Global Activity Assessment (on a horizontal 10 cm visual analogue scale), Patient Global Activity Assessment (on a horizontal 10 cm visual analogue scale), Physical Function (Health Assessment Questionnaire), Muscle-associated Enzymes (CK, LDH, AST, ALT, aldolase) and Extra-Muscular Activity Assessment (Extra-muscular portion of Myositis Disease Activity Assessment Tool).|12 weeks|All patients with evaluable (or complete) PD measurement and no major protocol deviations which impact on PD data were included in the PD analysis set.|||Participants|||Count of Participants
2713469|NCT01148771|Primary|Area Under the Curve From 48 to 72 Hours [AUC(48-72)]|AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.|0-24 hours after 3rd ertapenem dose||||mcg*hr/mL||Standard Deviation|Mean
2713470|NCT01148771|Secondary|Probability of Target Attainment (PTA)|After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT>MIC) is calculated at each MIC dilution.|Simulated Steady-State Exposure|The probability of achieving 40% T>MIC is reported at a MIC of 0.25mcg/mL and 0.5mcg/mL respectively.|||% of 5000 simulated patients|Participants||Number
2713471|NCT01148771|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.|3 days||||participants|||Number
2713472|NCT01148771|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)|Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.|5 or 30 minutes post start of infusion on Day 3|Each participant received ertapenem as a 5 minute infusion and as a 30 minute infusion, only in different order due to cross-over design. Data for all participants receiving each dosage regimen are included in each arm for results.|||mcg/mL||Standard Deviation|Mean
2713473|NCT01148745|Secondary|Serum Ferritin|Serum ferritin values were measured at all visits|7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)||||g/mL||Full Range|Median
2713475|NCT01148745|Primary|Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize|TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.|pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration||||weeks|||Number
2713476|NCT01148693|Primary|Number of Participants With Cholangitis|After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis|72 hours||||participants|||Number
2713477|NCT01148563|Secondary|U.S. Dollars Per Person-year|(emergency department costs + inpatient costs) / person-year|12 months|All heart failure patients included in the study|||U.S. dollars per person-year||Standard Error|Mean
2713478|NCT01148563|Primary|Events Per Person-year|(Number of emergency department visits + number of inpatient stays) / person-year|12 months|Used an Intention to Treat (ITT) Analysis. Missing outcome data were imputed as necessary.|||events/person-year||95% Confidence Interval|Mean
2713479|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."|||QTcF (msec)||Standard Deviation|Least Squares Mean
2713480|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Fridericia's Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia's method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTcF (msec)||Standard Deviation|Least Squares Mean
2713481|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."|||QTcB (msec)||Standard Deviation|Least Squares Mean
2713482|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett's method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTcB (msec)||Standard Deviation|Least Squares Mean
2713483|NCT01148537|Secondary|The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation~For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
2713495|NCT01148511|Secondary|Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Percentage of patients|||Number
2713722|NCT01147471|Primary|Morbidity|total days on ventilator, ICU length of stay, hospital length of stay|Measured daily during hospitalization (approx 1 month)|analysis is the mean and standard deviation for # days spent on each item measured|||days||Standard Deviation|Mean
2713484|NCT01148537|Primary|The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
2713485|NCT01148537|Secondary|The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
2713486|NCT01148537|Primary|The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
2713487|NCT01148524|Primary|Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|18 months after last vaccination V72P10 study.|Analysis was performed on the MITT dataset.|||UI/mL||95% Confidence Interval|Geometric Mean
2713488|NCT01148524|Primary|Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.|The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.|month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set. Naive group was not reported for this endpoint since GMR data for this group were not collected (subjects were enrolled in this study and no GMT values at 1m and 18 m after last vaccination in V72P10 are available).|||Geometric mean ratio||95% Confidence Interval|Geometric Mean
2713489|NCT01148524|Primary|Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set.Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2713490|NCT01148524|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.|||Percentage of subjects||95% Confidence Interval|Number
2713491|NCT01148511|Secondary|Quality of Life|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.|Visits 2, 6, 9, 12, and 15 (up to 12 months)|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Units on a scale||Full Range|Median
2714039|NCT01144637|Secondary|Related Grade >=3 Adverse Events|Incidence of any Grade >=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general only) and unsolicited AEs|within 29 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2713496|NCT01148511|Primary|Change in Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Letters||Full Range|Median
2713497|NCT01148511|Primary|Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||logMAR||Full Range|Median
2713498|NCT01148459|Secondary|Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score|The following growth parameters: weight, age/length and middle upper arm circumference for age z-score are reported.|At baseline (PRE), at Month 3 and at study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||age z-score||Standard Deviation|Mean
2713499|NCT01148459|Secondary|World Health Organization (WHO) HIV Clinical Classification Progression|"Clinical staging was done at each time point according to the WHO HIV/AIDS clinical staging system. Clinical stages included:~Stage 1 (asymptomatic or have persistent generalized lymphadenopathy),~Stage 2 (mildly symptomatic stage - presenting with unexplained weight loss of less than 10 percent of total body weight, recurrent respiratory infections or dermatological conditions),~Stage 3 (moderately symptomatic stage - presenting with weight loss of greater than 10 percent of total body weight, prolonged unexplained diarrhea or pulmonary tuberculosis, severe systemic bacterial infections or mucocutaneous conditions),~Stage 4 (severely symptomatic stage which includes all of the AIDS-defining illnesses) Additional categories included deceased and missing."|At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2713500|NCT01148459|Secondary|CD4+ Absolute Cell Counts|The CD4+ absolute cell counts are reported.|At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||number of cells/μL||Standard Deviation|Mean
2713501|NCT01148459|Secondary|Percentage of CD4+ Cells|The percentage of CD4+ cells is reported.|At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Percentage||Standard Deviation|Mean
2713502|NCT01148459|Secondary|HIV Viral Load|The HIV viral load is reported. Detectable HIV viral load: 400 or more copies/mL.|At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||copies/mL||Inter-Quartile Range|Median
2713503|NCT01148459|Secondary|Prevalent Hemoglobin Level|The prevalent hemoglobin level in subjects with a positive blood slide is reported as grams per deciliter (g/dl).|12 months post Dose 3 (Month 14)|The analysis was performed on the ATP population for efficacy, which included all subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.|||grams per deciliter||Standard Deviation|Mean
2713504|NCT01148459|Secondary|Asexual P. Falciparum Parasitemia Density|The number of subjects with a positive blood slide for asexual P. falciparum.|12 months post Dose 3 (Month 14)|The analysis was performed on children affected by prevalent parasitemia from the ATP population for efficacy, which included subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.|||Participants|||Count of Participants
2713505|NCT01148459|Secondary|Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia|The number of subjects affected by prevalent asexual P. falciparum parasitemia and prevalent moderate anemia. Moderate anemia = hemoglobin < 8 g/dL.|12 months post Dose 3 (Month 14)|The analysis was performed on the ATP population for efficacy, which included all subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.|||Participants|||Count of Participants
2713506|NCT01148459|Secondary|Number of Episodes With Severe Malaria According to Primary Case Definition|The number of episodes of severe malaria of primary case definition within and outside risk period. Primary case definition for severe malaria: P. falciparum > 2500 parasites per μL and with one or more marker of disease severity and without a diagnosis of co-morbidity.|From Day 0 to Month 14|The analysis was performed on the ATP population for efficacy, which included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.|||Episodes|||Number
2713507|NCT01148459|Secondary|Number of Episodes With Clinical Malaria Disease According to Primary Case Definition|Primary case definition for clinical malaria: P. falciparum asexual parasitemia > 2500 parasites/μL and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility.|From Day 0 to Month 14|The analysis was performed on the ATP population for efficacy, which included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.|||Episodes|||Number
2713508|NCT01148459|Secondary|Anti-HBs Antibody Titers|Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in mIU/mL.|12 months post Dose 3 (Month 14)|The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2713509|NCT01148459|Secondary|Anti-CS Antibody Concentrations|Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL.|12 months post Dose 3 (Month 14)|The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2713510|NCT01148459|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers|Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in milliinternational units per milliliter (mIU/mL).|Prior to vaccination (PRE) and one month post Dose 3 (Month 3)|The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2713511|NCT01148459|Secondary|Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations|Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL.|Prior to vaccination (PRE) and one month post Dose 3 (Month 3)|The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2713512|NCT01148459|Secondary|Number of Subjects With Non-malaria Related SAEs|SAEs (excluding malaria, cerebral malaria and P. falciparum parasitemia) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from 30 days before vaccine Dose 1 up to Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2713513|NCT01148459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day post-vaccination period (up to Day 90)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2713514|NCT01148459|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2713515|NCT01148459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 20 millimeters (mm) of injection site.|During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2713516|NCT01148459|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from 30 days before Dose 1 up to Month 14)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2713517|NCT01148420|Primary|Cessation of Bleeding Within 5 Days|Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5|3-5 days||||participants|||Number
2713518|NCT01148420|Secondary|Satisfaction and Willingness to Recommend Treatment|Participants were asked whether they would recommend this treatment to a friend|End of the trial; up to day 5||||participants|||Number
2713519|NCT01148420|Secondary|Patient Perception of the Acceptability of the Treatment|Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent.|End of the trial; up to day 5||||units on a scale||Full Range|Median
2713545|NCT01148225|Secondary|Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start|Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).|Weeks 8 to 246 (238 Weeks)|All participants in the ITT analysis set with active uveitis at study start with evaluable data at a given timepoint.|||percentage of participants||95% Confidence Interval|Number
2713520|NCT01148225|Other Pre-specified|Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time|The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 8 for participants with active uveitis.|Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||score on a scale||95% Confidence Interval|Mean
2713521|NCT01148225|Other Pre-specified|Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time|The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 0 for participants with inactive uveitis.|Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||score on a scale||95% Confidence Interval|Mean
2713522|NCT01148225|Other Pre-specified|Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to NEI and SUN criteria:~Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured."|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713523|NCT01148225|Other Pre-specified|Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry|Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for participants who had active uveitis when they entered the study.|Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713524|NCT01148225|Other Pre-specified|Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry|Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.|Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set that had evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713525|NCT01148225|Other Pre-specified|Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry|Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit.|Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 8) with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713526|NCT01148225|Other Pre-specified|Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry|Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. Data not presented after Week 234 as no participants remained on study as of Week 234.|Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, and 234|All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 0) with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2714205|NCT01143402|Other Pre-specified|Changes in Maximum Standardized Uptake Value on FLT-PET Scans|A paired student's t-test will be performed. Analysis of variance will also be performed to obtain the significance of FLT-PET uptake on each lesion between patients.|Baseline up to 60 minutes post injection|||||||
2713527|NCT01148225|Other Pre-specified|Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time|Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm * 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0: ˂ 1 cell; Grade 0.5+: 1 - 5 cells; Grade 1+: 6 - 15 cells; Grade 2+: 16 - 25 cells; Grade 3+: 26 - 50 cells; and Grade 4+: ≥ 50 cells.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713528|NCT01148225|Other Pre-specified|Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time|Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in right eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.|Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percent change from baseline||95% Confidence Interval|Mean
2713529|NCT01148225|Other Pre-specified|Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time|Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in left eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.|Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percent change from baseline||95% Confidence Interval|Mean
2713530|NCT01148225|Other Pre-specified|Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time|Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in right eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percent change from baseline||95% Confidence Interval|Mean
2713531|NCT01148225|Other Pre-specified|Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time|Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in left eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percent change from baseline||95% Confidence Interval|Mean
2713532|NCT01148225|Secondary|Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time|Using corrective lenses based on that visit's refraction testing, participant's BCVA was measured using an ETDRS logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 to 0.1; higher values indicate visual impairment. Data presented includes the mean of both eyes for all participants (active or inactive uveitis) for all study time points.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each study timepoint.|||Log (Mar) BCVA Both Eyes||Standard Deviation|Mean
2713533|NCT01148225|Secondary|Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry|Percentage of participants at each study time point without a worsening of BCVA by ≥15 letters on the ETDRS in both eyes relative to Week 8 for participant who had active uveitis when they entered the study.|Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713534|NCT01148225|Secondary|Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry|Percentage of participants at each study time point without a worsening of Best Corrected Visual Acuity (BCVA) by ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.|Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713535|NCT01148225|Secondary|Percentage of Participants Not Using Systemic Corticosteroids Over Time|Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data presented for participants not using systemic corticosteroids at each timepoint.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at each timepoint.|||percentage of participants||95% Confidence Interval|Number
2713546|NCT01148225|Secondary|Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start|Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).|366 Weeks|All participants in the ITT analysis set with inactive uveitis with evaluable data at a given timepoint.|||percentage of participants||95% Confidence Interval|Number
2713536|NCT01148225|Secondary|Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time|Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set receiving systemic corticosteroids at Week 0 with evaluable data at a given timepoint.|||percent change from baseline||95% Confidence Interval|Mean
2713537|NCT01148225|Secondary|Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time|Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data not presented after Week 198 as no participants remained on study as of Week 198.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198|All participants in the ITT analysis set who received systemic corticosteroids at Week 0 with evaluable data at a given timepoint.|||percent change from baseline||95% Confidence Interval|Mean
2713538|NCT01148225|Secondary|Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time|Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with inactive uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.|||milligrams||Standard Deviation|Mean
2713539|NCT01148225|Secondary|Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time|Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with active uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.|||milligrams||Standard Deviation|Mean
2713540|NCT01148225|Secondary|Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study|Percentage of participants who started uveitis-related systemic corticosteroids during the study.|366 Weeks|All participants in the ITT analysis set without systemic corticosteroids at baseline with evaluable data at a given timepoint.|||percentage of participants||95% Confidence Interval|Number
2713541|NCT01148225|Secondary|Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start|Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence, among participants with active uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used include: CM=concomitant medications, NQ=non-quiescence.|366 Weeks|All participants in the ITT analysis set with active uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.|||percentage of participants|||Number
2713542|NCT01148225|Secondary|Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start|Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence among participants with inactive uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used are as follows: CM=concomitant medications; NQ=non-quiescence.|366 Weeks|All participants in the ITT analysis set with inactive uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.|||percentage of participants|||Number
2713543|NCT01148225|Secondary|Percentage of Participants With Steroid-free Quiescence Over Time|Steroid-free quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+ and no uveitis-related corticosteroids on the day of assessment.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set in steroid-free quiescence with evaluable data at a given timepoint.|||percentage of participants||95% Confidence Interval|Number
2713544|NCT01148225|Secondary|Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time|Dilated indirect ophthalmoscopy is performed to determine both vitreous haze grading and the absence/presence of inflammatory chorioretinal and/or inflammatory retinal vascular lesions. The number of AC cells observed within a 1 mm * 1 mm slit beam was recorded for each eye and this number was used to determine the grade according to Standardization of Uveitis Nomenclature (SUN) criteria. Grading of VH was based on the National Eye Institute (NEI) publication which was adapted by the SUN working group. The percentage of participants with new active inflammatory lesions or grade ≥2 in AC cells or grade ≥2 in VH are presented.|Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|All participants in the ITT analysis set with evaluable data at a given time point.|||percentage of participants||95% Confidence Interval|Number
2713547|NCT01148225|Secondary|Percentage of Participants in Quiescence Over Time|Quiescence is defined as no active inflammatory lesions and anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤0.5+. Participants with active uveitis at study entry could have been in quiescence at Week 0 because all participants were evaluated for uveitis status at the Final/Early Termination visit of the lead-in study and the Week 0 visit could have occurred up to 28 days later during which time the participant's disease status may have changed.|Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246|ITT analysis set: includes all participants who received at least one dose of study medication with evaluable data at a given timepoint.|||percentage of participants||95% Confidence Interval|Number
2713548|NCT01148225|Primary|Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit|Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.|Baseline to Final Visit (Up to 366 weeks)|Safety analysis set.|||mmHg||Standard Deviation|Mean
2713549|NCT01148225|Primary|Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit|Temperature was measured while the participant was sitting.|Baseline to Final Visit (Up to 366 weeks)|Safety analysis set.|||Centigrade||Standard Deviation|Mean
2713550|NCT01148225|Primary|Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit|Respiratory rate (respirations per minute) was measured while the participant was sitting.|Baseline to Final Visit (Up to 366 weeks)|Safety analysis set.|||respirations per minute||Standard Deviation|Mean
2713551|NCT01148225|Primary|Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit|Heart rate (beats per minute) was measured while the participant was sitting.|Baseline to Final Visit (Up to 366 weeks)|Safety analysis set.|||beats per minute||Standard Deviation|Mean
2713552|NCT01148225|Primary|Chemistry: Number of Participants With PCS Values|PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase; AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase; g/L=grams/liter; mmol/L=millimoles/liter; ULN=upper limit of normal.|Baseline to Final Visit (Up to 366 weeks)|Safety analysis set.|||participants|||Number
2713553|NCT01148225|Primary|Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values|PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations used include g=grams; L=liters.|Baseline to Final Visit (Up to 366 weeks)|Safety analysis set.|||participants|||Number
2713554|NCT01148225|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.|Baseline to Final Visit (up to 366 weeks)|Safety analysis set: includes all participants who received at least one dose of study medication.|||participants|||Number
2713555|NCT01148056|Secondary|Accuracy|To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
2713556|NCT01148056|Secondary|Quantity of Circulating Tumor Cells|To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
2713557|NCT01148056|Secondary|Tissue Microarray|To determine changes in the tumor induced by radiation as assessed by tissue microarray.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
2713558|NCT01148056|Secondary|Surgical Complication Rate|To determine the surgical complication rate in patients who received preoperative radiation therapy.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
2713559|NCT01148056|Secondary|Pelvic Control Rate|To determine the pelvic control rate of patients after short course radiation therapy and surgery.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
2713560|NCT01148056|Primary|Bowel Quality of Life|To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.|2 years|Study was terminated early due to slow accrual. Analysis was not performed.||||||
2713561|NCT01148017|Secondary|Number of Subjects Reporting Unsolicited AEs and SAEs|Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.|Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).|Analysis was done on the Post MenACWY at 60 months safety set ie, all subjects who received a vaccination at 60 months and were assessed for postvaccination safety, and on the Post MenACWY at 40 Months Safety Set, ie, the Naive subjects enrolled at 40 months of age who received vaccination at 40 months and were assessed for post vaccination safety.|||Number of subjects|||Number
2713562|NCT01148017|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity|"Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.~Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs."|From day 1 to 7 after vaccination.|Analysis was done on the Solicited Safety Set (from 6 hours to day 7), ie, all subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.|||Subjects|||Number
2713563|NCT01148017|Secondary|Percentage of Subjects With Seroresponse at 1 Month Post-vaccination|"The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.~Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4."|Visit 11, 1 month after vaccination.|Analysis was done on the PPS Post-MenACWY-CRM.|||Percentage of subjects||95% Confidence Interval|Number
2713564|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination|The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.|Visit 11, 1 month after vaccination.|Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM (PPS Post-MenACWY-CRM), ie, all subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.|||Percentages of subjects||95% Confidence Interval|Number
2713565|NCT01148017|Secondary|hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age|The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.|||Titers||95% Confidence Interval|Geometric Mean
2713566|NCT01148017|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-months of age.|Analysis was done on the PPS 40-month persistence.|||Titers||95% Confidence Interval|Geometric Mean
2713567|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.|||Percentages of subjects||95% Confidence Interval|Number
2713568|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9, 40 months of age.|Analysis was done on the PPS 40-month persistence.|||Percentages of subjects||95% Confidence Interval|Number
2713569|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age|Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.|||Percentages of subjects||95% Confidence Interval|Number
2713570|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-month visit.|Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.|||Percentages of subjects||95% Confidence Interval|Number
2713571|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment|"The subject was asked to rate his global evaluation of the efficacy of treatment using the following 5-point scale:~0=not at all effective~a little bit effective~moderately effective~quite a bit effective~extremely effective."|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
2713572|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment|Subject was asked to rate the severity of his constipation using a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
2713589|NCT01147900|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
2713573|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
2713574|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
2713575|NCT01147926|Secondary|Days With Rescue Medication Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||Days/week||Standard Deviation|Mean
2713576|NCT01147926|Secondary|Bisacodyl Tablets Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||Tablets/week||Standard Deviation|Mean
2713577|NCT01147926|Secondary|Time to First SCBM After Investigational Product Intake on Day 1||Day 1|mITT.|||hours||95% Confidence Interval|Median
2713578|NCT01147926|Secondary|Percent SBM With Sensation of Complete Evacuation||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
2713579|NCT01147926|Secondary|Percent SCBM With No Straining and Severe/Very Severe Straining|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
2713580|NCT01147926|Secondary|Percent SBM With a Consistency of Normal and Hard/Very Hard|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
2713581|NCT01147926|Secondary|SCBM Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||SCBM/week||Standard Deviation|Mean
2713582|NCT01147926|Secondary|Percentage of Subjects With an Increase of at Least 1 SCBM Per Week||Over 12 week treatment period|mITT|||percentage of subjects|||Number
2713583|NCT01147926|Secondary|Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period||Over 12 week treatment period|mITT|||percentage of subjects|||Number
2713584|NCT01147926|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 12 week treatment period|Modified Intent-to-treat Population (mITT) included all subjects randomized into the study except those excluded due to a major good clinical practice (GCP) breach at one site, who took at least 1 dose of the investigational product.|||percentage of subjects|||Number
2713585|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 8.5 up to study end (one month post Year 10 booster vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
2713586|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..|At Year 8.5|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
2713587|NCT01147900|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
2713588|NCT01147900|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||subjects|||Number
2714206|NCT01143402|Other Pre-specified|Change in PTEN|Correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
2713590|NCT01147900|Primary|Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.|"A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination.~A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL."|At 1 month post Year 10 booster vaccination|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2713591|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2713592|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2713593|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2713594|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2713595|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2713596|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||Participants|||Count of Participants
2713597|NCT01147900|Primary|Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2713598|NCT01147900|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||Participants|||Count of Participants
2713599|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||IU/mL||95% Confidence Interval|Geometric Mean
2713600|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus.|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||Participants|||Count of Participants
2713601|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||IU/mL||95% Confidence Interval|Geometric Mean
2713602|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||Participants|||Count of Participants
2713603|NCT01147874|Secondary|Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)|"PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with No answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA."|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.|||Percentage of participants||95% Confidence Interval|Number
2713604|NCT01147874|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.|||Percentage of participants||95% Confidence Interval|Number
2713605|NCT01147874|Primary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis.|Week 0 through Week 8|Full analysis set (FAS) population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.|||Percentage of participants||95% Confidence Interval|Number
2713606|NCT01147848|Other Pre-specified|Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at Day 168|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The second part is a 20 centimeter VAS that has endpoints labelled best imaginable health state and worst imaginable health state anchored at 100 and 0, respectively. Participants were asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS that best represents their own health on that day. Analysis was performed using ANCOVA with covariates of Baseline VAS score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||scores on a scale||Standard Error|Least Squares Mean
2713607|NCT01147848|Other Pre-specified|"Percentage of Participants With No Problems in the EQ-5D Descriptive System Dimensions at Day 168/Week 24"|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a three-point Likert scale (1=no problems, 2=some problems and 3=severe problems). Respondents are asked to choose one level that reflects their own health state today for each of the five dimensions."|Day 168/Week 24|ITT Population. Only those participants available at the indicated time point were assessed.|||percentage of participants|||Number
2713617|NCT01147848|Secondary|Serial FEV1 (0-24 Hours)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . The pre-dose FEV1 assessment and the individual serial FEV1 assessments at Day 168/Week 24 at the indicated time points (pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 11 hours, 12 hours, 12.5 hours, 13 hours, 14 hours, 16 hours, 20 hours, 23 hours, and 24 hour s) were summarized.|Day 168|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Deviation|Mean
2714207|NCT01143402|Other Pre-specified|Change in p-ERK|Decrease in p-ERK will be correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
2713608|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score for Participants 12 Years of Age and Older (AQLQ + 12)|"The AQLQ is a disease-specific, self-administered quality of life (QOL) questionnaire developed to evaluate the impact of asthma treatments on the QOL of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The response format consists of a 7-point scale: a value of 1 indicates total impairment; a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions, provided at least 90% of the questions have been answered; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Change from Baseline was calculated as the Day 168 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline total AQLQ score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
2713609|NCT01147848|Other Pre-specified|Number of Healthcare Contacts Related to Asthma or the Treatment of Asthma From Baseline to Day 168|All unscheduled asthma-related visits to a physician's office, visits to urgent care, visits to the emergency department, and hospitalizations (to the general ward [GW] or the intensive care unit [ICU]) that were associated with asthma exacerbations were recorded.|Baseline to Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||visits per participant||Standard Deviation|Mean
2713610|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Control Test (ACT) Scores at Day 168|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the Day 168 value minus the Baseline value."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed. Analysis was performed using ANCOVA with covariates of Baseline total ACT score, country, sex, age, and treatment.|||Scores on a scale||Standard Error|Least Squares Mean
2713611|NCT01147848|Other Pre-specified|Baseline FEV1 by Completion Status|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.|Baseline|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Deviation|Mean
2713612|NCT01147848|Secondary|Change From Baseline in Trough FEV1 at Day 168|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Trough FEV1 is defined as the pre-dose measurement on Day 168/Week 24. Any missing data at Day 168/Week 24 was imputed using the last observation carried forward (LOCF). Baseline was the pre-dose measurement on Day 1. Change from Baseline was calculated as the pre-dose measurement on Day 168/Week 24 minus the Baseline value.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2713613|NCT01147848|Secondary|Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1|The number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated at 12-hours post-dose and at 24-hours post-dose on Day 168.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
2713614|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline and Day 168 was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Deviation|Mean
2713615|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 1 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Randomization|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2713616|NCT01147848|Secondary|Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1|Time to onset of bronchodilator effect at Day 1 is defined as the actual time during the 4-hour serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) measurements that the participant first meets or exceeds a 12% and 200 mL increase over Baseline and was derived at Day 1 only. Time to onset was calculated over 0 to 4 hours (5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours) post-dose. Participants who never exceeded a 12% and 200 mL increase over Baseline were censored at the actual time of their last FEV1 measurement.|Baseline to Day 1|ITT Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
2713713|NCT01147497|Secondary|Acceptability of Discomfort Associated With Insertion||assessed at one week after insertion and at one month after insertion|Data were not collected for this outcome measure. The follow-up participant questionnaires developed for this study were piloted prior to study initiation and this question was removed for clarity, to focus on the primary study aims, and to reduce participant burden.||||||
2713618|NCT01147848|Primary|Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168/Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2713619|NCT01147822|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of response until the earliest date of disease progression/death (up to 38 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Months||95% Confidence Interval|Median
2713620|NCT01147822|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Weeks||95% Confidence Interval|Median
2713621|NCT01147822|Secondary|Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC|The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian)|||Participants|||Number
2713622|NCT01147822|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization until death (up to 44 months)|ITT Population (Asian)|||Months||95% Confidence Interval|Median
2713623|NCT01147822|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization to the earliest date of disease progression or death (up to 39 months)|Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea.|||Months||95% Confidence Interval|Median
2713624|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to >=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population|||Days||Standard Deviation|Mean
2713625|NCT01147809|Secondary|Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population|||Days||Standard Deviation|Mean
2713634|NCT01147809|Secondary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II|ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1|Safety Population|||participants|||Number
2713626|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 1 to Cycle 6|ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.|||Days||Standard Deviation|Mean
2713627|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II|As per the CTCAE version 4.0, participants with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets <150Gi/L) at least once within cycle are presented in the category title as n=X,X.|Cycle 1 to Cycle 6|ITT Population|||Participants|||Number
2713628|NCT01147809|Secondary|Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 1 Day 1 to last assessment in Cycle 6|ITT Population:Participants with platelet count data in at least one cycle in the study.|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713629|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713630|NCT01147809|Secondary|Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II|Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713631|NCT01147809|Secondary|Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.|Day 15 (averaged across cycles 1 to 6)|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
2713632|NCT01147809|Secondary|Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.|Day 8 (averaged across cycles 1 to 6)|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
2713633|NCT01147809|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|C1D4|Safety Population|||participants|||Number
2713714|NCT01147497|Secondary|Time for Insertion Procedure||assessed immediately after IUD insertion|Data were not collected for this outcome measure. The provider questionnaire developed for this study was piloted prior to study initiation and this question was removed for clarity and to focus on the primary study aims.||||||
2713635|NCT01147809|Secondary|Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II|Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase >=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population|||participants|||Number
2713636|NCT01147809|Secondary|Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II|"Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as Any grade increase, Increase to Grade 3 or Grade 4. Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles)."|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population|||participants|||Number
2713637|NCT01147809|Secondary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).|After baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
2713638|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.|Cycle 1 to Cycle 6|ITT Population|||Dose Intensity (%)||Standard Deviation|Mean
2713639|NCT01147809|Secondary|Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.|Cycle 1 to Cycle 6|ITT Population|||Participants|||Number
2713640|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).|Cycle 1 to Cycle 6|ITT Population|||Participants|||Number
2713641|NCT01147809|Secondary|Number of Participants Requiring a Platelet Transfusion in Phase II|Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.|Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation|ITT Population|||Participants|||Number
2713642|NCT01147809|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.|Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up|ITT Population: Participants with at least one visit within the cycle.|||Participants|||Number
2713681|NCT01147653|Secondary|Modified Ashworth Scale at Baseline|The Modified Ashworth Scale uses a 6 point scale (range 0, 1, 1+, 2, 3, or 4) to measure spasticity in 5 body regions (central, right upper extremity, left upper extremity, right lower extremity, and left lower extremity). Scores of 0 indicate no increase in muscle tone whereas a score of 4 indicates rigidity in flexion or extension.|Baseline|Patients are classified by their maximum score, regardless of body region.|||Participants|||Count of Participants
2713643|NCT01147809|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II|AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)|Safety Population|||Participants|||Number
2713644|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I|Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.|All time on chemotherapy treatment|Safety Population|||Participants|||Number
2713645|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within Cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).|Cycle 1 to Cycle 6|Safety Population|||Dose Intensity (%)||Standard Deviation|Mean
2713646|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population|||Days||Standard Deviation|Mean
2713647|NCT01147809|Secondary|Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population|||Days||Standard Deviation|Mean
2713648|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 2 to Cycle 6|Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to >=150Gi/L are included.|||Days||Standard Deviation|Mean
2713649|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count|As per the CTCAE version 4.0, par. with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets <150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.|Cycle 1 to Cycle 6|Safety Population|||Participants|||Number
2713650|NCT01147809|Secondary|Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 2 Day 1 to last assessment in Cycle 6|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713715|NCT01147497|Secondary|The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD||assessed immediately after IUD insertion||||participants|||Number
2713716|NCT01147497|Secondary|Patient Perceived Pain on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).|immediately after insertion||||units on a scale||Full Range|Median
2713651|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713652|NCT01147809|Secondary|Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I|Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713653|NCT01147809|Secondary|Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I|Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
2713654|NCT01147809|Primary|Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).|Day 1 (averaged across cycles 1 to 6)|Intent-to Treat (ITT) Population: all randomized participants.|||Giga (10^9) cells per liter (Gi/L)||Geometric Coefficient of Variation|Geometric Mean
2713655|NCT01147809|Primary|Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|C2D4, C2D8, C5D8, C6D15|Safety Population|||Participants|||Number
2713656|NCT01147809|Primary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I|ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.|Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15|Safety Population|||Participants|||Number
2713657|NCT01147809|Primary|Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I|The number of participants with at least 1 change from Baseline in creatinine, with an increase >=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
2713682|NCT01147653|Secondary|Change in Difficult Child Score From Baseline to Year 1|Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range. Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change.|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.|||units on a scale||Standard Error|Mean
2713658|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I|Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
2713659|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
2713660|NCT01147809|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I|AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)|Safety Population|||Participants|||Number
2713661|NCT01147744|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).|Upto 8 Weeks|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Participants|||Count of Participants
2713662|NCT01147744|Secondary|Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period|The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Night-time number of inhalations||Standard Error|Least Squares Mean
2713663|NCT01147744|Secondary|Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period|The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Day-time number of inhalations||Standard Error|Least Squares Mean
2713664|NCT01147744|Secondary|Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period|Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Night-time symptom scores on a scale||Standard Error|Least Squares Mean
2714208|NCT01143402|Other Pre-specified|Change in p-AKT|Correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
2713665|NCT01147744|Secondary|Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period|Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Day-time symptom scores on a scale||Standard Error|Least Squares Mean
2713666|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period|The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of rescue-free nights||Standard Error|Least Squares Mean
2713667|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period|The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of rescue-free days||Standard Error|Least Squares Mean
2713668|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of symptom-free nights||Standard Error|Least Squares Mean
2713669|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period|Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants.|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of symptom-free days||Standard Error|Least Squares Mean
2713670|NCT01147744|Secondary|Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period|The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Liters per minute||Standard Error|Least Squares Mean
2713671|NCT01147744|Secondary|Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period|Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)|Baseline up to Week 8|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Liters per minute||Standard Error|Least Squares Mean
2713690|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Self Care Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Self Care score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.|||units on a scale||Standard Error|Mean
2713672|NCT01147744|Primary|Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)|Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.|Baseline and Week 8|ITT population. When possible, data from participants who withdrew prematurely from the study were included in the analyses. Any evaluable subject whose FEV1 measurement at Week 8 was missing was included in the analysis by imputation, using the preceding non-missing FEV1 value (last observation carried forward [LOCF]).|||Liters||Standard Error|Least Squares Mean
2713673|NCT01147653|Post-Hoc|Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI) of All Subjects 1 Year Post-infusion With Autologous UCB|Change in whole brain connectivity measured by diffusion tensor magnetic resonance imaging (MRI). Changes in connectivity are normalized to white matter volume.|1 year post-infusion with autologous umbilical cord blood|This group combines patients who received Autologous Umbilical Cord Blood whether at baseline or 1 year post-infusion with Placebo and is limited to patients without morphologic brain abnormalities that prevented accurate anatomical image parcellation. Low/High dose is defined as the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|||Number of connections x10e5||Standard Deviation|Mean
2713674|NCT01147653|Post-Hoc|Peabody Gross Motor Quotient Change Score 1 Year After Receiving Autologous UCB.|The Peabody Developmental Motor Scales - Second Edition (PDMS-2), Gross Motor Quotient change score was calculated for each patient at 1 year after infusion with autologous umbilical cord blood. Analyzed by infused dose, above or below the median. The Gross Motor Quotient score from the PDMS-2 was used in this study to evaluate gross motor function. The Gross Motor Quotient measures the ability to use large muscle systems for locomotion, maintain a stable posture when not moving, and throw/catch objects. The range of possible scores is 41 to 164. High scores indicate better gross motor function. Lower scores indicate less gross motor function ability.|1 year post-infusion with autologous umbilical cord blood|This group combines patients who received Autologous Umbilical Cord Blood at baseline or 1 year post-infusion with Placebo, and who are within the age range specified for the PDMS-2. The threshold defining Low/High dose is the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|||units on a scale||Full Range|Median
2713675|NCT01147653|Post-Hoc|Observed Minus Expected GMFM-66 Change Score of All Subjects Receiving Autologous UCB and Who Are Greater Than or Equal to 2 Years of Age|Validated functional curves were used to identify the expected 1-year change in GMFM-66 score given each child's age and Gross Motor Function Classification System (GMFCS) Level at baseline. The difference between observed change (in this study) and expected change was then calculated for each participant. The threshold defining Low/High dose is the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|1 year post-infusion with autologous umbilical cord blood|Patients who received cord blood at baseline and 1 year post-infusion with Placebo, and who are >=2 years old (to allow calculation of expected GMFM-66 change scores from published data). An additional 6 are excluded because change scores were not observable due to subject withdrawal (5) or inability to comply due to a broken leg (1).|||units on a scale||Full Range|Median
2713676|NCT01147653|Post-Hoc|Gross Motor Function Measure 66 (GMFM-66) Change Score at 1 Year by Infused Dose|Gross Motor Function Measure 66 (GMFM-66) Change Score at 1 Year. Analyzed by infused dose, above or below the median. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.|1 Year|Patients randomized to Autologous Umbilical Cord Blood were divided into two groups for this analysis: Low and High dose. The median dose infused in these 32 patients was used as the cut point to define Low and High doses: 1.98x10e7 total nucleated cells per kilogram of patient weight (TNCC/kg).|||units on a scale||Full Range|Median
2713677|NCT01147653|Other Pre-specified|Change in Barry-Albright Dystonia Total Score From Baseline to Year 1|The Barry-Albright Dystonia Scale measures generalized dystonia in eight body regions (eyes, mouth, neck, trunk, and the four extremities) using an ordinal scale (0=no dystonia, 1=slight dystonia, 2=mild dystonia, 3=moderate dystonia, and 4=severe dystonia). Individual scores for each region are summed to obtain a total score. The total score can range from 0 to 32 and higher scores indicate an overall greater degree of dystonia. The change in Barry-Albright Dystonia Total Score was evaluated from Baseline to Year 1. Positive numbers indicate increasing dystonia, negative numbers indicate a decrease in dystonia, and zero indicates no change.|Baseline to Year 1||||units on a scale||Full Range|Median
2713678|NCT01147653|Secondary|Parent Experience of Child Illness|This outcome measure was not used in this study because it had not been validated for children with Cerebral Palsy.|Baseline to Year 1|||||||
2713679|NCT01147653|Secondary|Change in Bruininks-Oseretsky-2 Total Motor Composite From Baseline to Year 1|The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, (BOT-2) evaluates motor function in four areas: stability, mobility, strength, coordination, and object manipulation. A Total Motor Composite is then calculated and expressed on a normal distribution with mean 50 and standard deviation of 10. Higher scores indicate better motor function. The BOT-2 Total Motor Composite was used to measure motor function in children at age 6 in this study. The study intended to evaluate change in the BOT-2 Total Motor Composite from Baseline to Year 1, where positive change indicates improvement in motor function, negative change indicates decrease in motor function, and zero indicates no change.|Baseline to Year 1|The BOT-2 Total Motor Composite was available at Baseline and Year 1 in only 1 subject. The change score for that subject is reported here.|||units on a scale|||Number
2713680|NCT01147653|Secondary|Modified Ashworth Scale at Year 1|The Modified Ashworth Scale uses a 6 point scale (range 0, 1, 1+, 2, 3, or 4) to measure spasticity in 5 body regions (central, right upper extremity, left upper extremity, right lower extremity, and left lower extremity). Scores of 0 indicate no increase in muscle tone whereas a score of 4 indicates rigidity in flexion or extension.|Year 1|Patients are classified by their maximum score, regardless of body region.|||Participants|||Count of Participants
2713683|NCT01147653|Secondary|Change in Parent-Child Dysfunctional Interaction From Baseline to Year 1|Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range. Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change.|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.|||units on a scale||Full Range|Median
2713684|NCT01147653|Secondary|Change in Parental Distress From Baseline to Year 1|"Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range.~Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change."|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.|||Change in percentile score||Standard Error|Mean
2713685|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Total Problems From Baseline to Year 1|"Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change."|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.|||units on a scale||Full Range|Median
2713686|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Externalizing Problems From Baseline to Year 1|"Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change."|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.|||units on a scale||Standard Error|Mean
2713687|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Internalizing Problems From Baseline to Year 1|"Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change."|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.|||units on a scale||Full Range|Median
2713688|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Social Function Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Social Function score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.|||units on a scale||Standard Error|Mean
2713689|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Mobility Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Mobility score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.|||units on a scale||Full Range|Median
2713712|NCT01147497|Secondary|Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women||assessed immediately following insertion|Data were not collected for this outcome measure. The participant questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about prior pregnancies) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.||||||
2713691|NCT01147653|Secondary|Change in Assisting Hand Assessment (AHA) Score From Baseline to Year 1|The Assisting Hand Assessment (AHA) measures the use of hemiplegic cerebral palsy patients' involved hand in tasks involving two hands. The test is valid for ages 18 months to 12 years. The score is an interval scale ranging from 22 to 88 with higher numbers indicating more effective use of the affected hand in performance of bimanual tasks. Change in this score was evaluate between Baseline and Year 1. Positive numbers indicate more effective use of the affected hand, negative numbers indicate a reduction in the effective use of the affected hand, and a zero indicates no change.|Baseline to Year 1|Participants who were less than 18 months old, or had diplegia or quadriplegia were excluded. For those with unspecified typography, AHA scores were excluded if scores on either the Modified Ashworth Scale or Barry-Albright Dystonia scale indicated neither or both of the upper extremities were involved.|||units on a scale||Standard Error|Mean
2713692|NCT01147653|Secondary|Change in Cognitive Z-Score From Baseline to Year 1|Because patients in this study were evaluated with different cognitive assessments based on their age at the time of assessment (The Bayley-III Cognitive Composite, the WPSSI-III Full Scale IQ, and the WISC-IV Full Scale IQ Composite), with some patients being assessed using different tools at subsequent visits during the trial, a method for combining the assessments was employed to evaluate change in cognitive function over time in as many patients as possible. A cognitive Z-score was calculated for each participant at Baseline and Year 1 by adjusting each score by the relevant assessments' population mean and standard deviation. The Z-scores represent the distance from the population mean, as measured by standard deviations. The analysis presented here summarizes the change in Z-score between Baseline and Year 1. A positive number indicates an increase in cognitive function, a negative number indicates a decrease, and zero indicates no change.|Baseline to Year 1|When using all available cognitive assessments, the change in cognitive Z-score was available for 42 of the 63 participants.|||Z scores||Standard Error|Mean
2713693|NCT01147653|Secondary|Change in the Wechsler Intelligence Scale for Children (WISC-IV) From Baseline to Year 1.|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. The WISC-IV is designed for children 6 years 0 months to 16 years 11 months. This study used the Full Scale IQ, which ranges from 45 to 155 with a mean of 100 and standard deviation of 15. Higher scores indicate stronger cognitive function. Scores between 90 and 110 are considered to be within the range of average IQ.|Baseline to Year 1|Only one patient in this trial was evaluated with the WISC-IV and thus change over time could not be evaluated using this outcome measure. The single value for this patient is reported here.|||Full Scale IQ Points|||Number
2713694|NCT01147653|Secondary|Change in Wechsler Preschool and Primary Scale of Intelligence (WPPSI) III Full Scale Intelligence Quotient (IQ) for Younger Children (Ages 2 Years & 6 Months to 3 Years & 11 Months) From Baseline to Year 1.|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. There are two versions of the WPPSI-III for two different age ranges: 2 years & 6 months to 3 years & 11 months, and 4 years to 7 years & 3 months. The Full Scale IQ is calculated for both age ranges and provides a continuous score with an average of 100 and a standard deviation of 15. Change from Baseline to Year 1 was evaluated, with positive numbers indicating an increase in cognitive ability, negative numbers indicating a decrease in cognitive ability, and zero indicating no change.|Baseline to Year 1|Change scores were evaluable in only 2 subjects who were assessed with the WPPSI-III at both Baseline and Year 1. One subject was randomized to Autologous Cord Blood and the other to Placebo.|||units on a scale|||Number
2713695|NCT01147653|Secondary|Change in Bayley Scales of Infant and Toddler Development-III, Cognitive Composite From Baseline to Year 1|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. The Bayley-III is designed to assess developmental functioning of infants and toddlers. Scores for the Cognitive Composite range from 1 to 19 and results in the range of 8 to 12 are considered average. The outcome measure reported here is the change in Cognitive Composite between Baseline to Year 1. Positive numbers indicate increases in cognitive functioning, negative numbers indicate a decrease, and zero indicates no change.|Baseline to Year 1|The Bayley III is an age-specific test and was used for 42 patients at Baseline. A total of 27 of these patients were also scored with the Bayley III at Year 1. The results here represent change from Baseline to Year 1 in the 27 participants assessed with the Bayley III at both time points.|||units on a scale||Standard Error|Mean
2713696|NCT01147653|Secondary|Correlation Between Clinical Response and RNA Expression of Neural, Endothelial and Inflammatory Cytokines Measured by RNA Arrays in Cord Blood Cells Given to These Patients.|Various pre-selected neural, angiogenic, and anti-inflammatory markers expressed by UCB cells and clinical response will be evaluated.|2 years||2022-01-31|01/2022||||
2713697|NCT01147653|Secondary|Change in Loes Score of Functional MRI From Baseline to Year 1 and From Year 1 to Year 2|No data were collected from this procedure because enrolled subjects who were eligible to receive fMRI were unable to comply with the procedure.|Baseline, Year 1, Year 2|No data was available.||||||
2713698|NCT01147653|Secondary|Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI)|Change in number of connections in the brain as measured by diffusion tensor magnetic resonance imaging (MRI). Changes in connectivity are normalized to white matter volume of the brain. A positive number indicates an increase in connections, a negative number indicates a decrease, and zero indicates no change. The number of connections is expressed in terms of 10e5. For example, a change of 1 indicates an increase of 1x10e5 or 100,000 connections.|Baseline to Year 1|Patients without substantial morphologic brain abnormalities that prevented accurate anatomical image parcellation.|||Number of connections x10e5||Full Range|Median
2713699|NCT01147653|Secondary|Change in CP-QOL Score|"Children age four years or older at study entry were assessed using the disease-specific CP-QOL Child assessment tool as completed by a parent. The CP-QOL Child primary-caregiver proxy form is designed for children 4 - 12 with cerebral palsy and contains 66 items which assess physical, emotional, and social well being as well as access to services and acceptance by others. Scores are summarized in seven topic areas. Scores in each area range from 0 (worst health) to 100 (best health). The change score from Baseline to Year 1 is summarized here for each item. Negative scores indicated a decrease in quality of life, positive scores indicate an increase and zero indicates no change."|Baseline, Year 1|The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points.|||units on a scale||Full Range|Median
2713700|NCT01147653|Secondary|Change in IT-QOL Questionnaire Score|The Infant and Toddler Quality of Life Questionnaire (IT-QOL) was utilized for children ages one to three years at study entry.This 97-item questionnaire is completed by the parents and covers 12 concepts related to the physical, mental, and social well being of the child and the impact of their illness on the family. Scores range from 0 (worst health) to 100 (best health). The change from Baseline to Year 1 is summarized here for each of the 12 items on the questionnaire. Negative values indicate a decline in quality of life over time, positive values indicate an improvement, and zero indicates no change.|Baseline to Year 1|The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points.|||units on a scale||Full Range|Median
2713701|NCT01147653|Secondary|Change in Peabody Gross Motor Quotient From Baseline to Year 1|The Peabody Developmental Motor Scales - Second Edition (PDMS-2) measures gross and fine motor skills in children from birth through five years of age. The Gross Motor Quotient score from the PDMS-2 was used in this study to evaluate gross motor function. The Gross Motor Quotient measures the ability to use large muscle systems for locomotion, maintain a stable posture when not moving, and throw/catch objects. The range of possible scores is 41 to 164. High scores indicate better gross motor function. Lower scores indicate less gross motor function ability. The change in Gross Motor Quotient from Baseline to Year 1 was evaluated in this study. Positive numbers indicate an increase in gross motor ability, negative numbers indicate decreases in gross motor function, and a zero indicates no change.|Baseline to Year 1|Participants outside of the applicable age range for the PDMS-2 at Baseline or Year 1 were excluded from the analysis.|||units on a scale||Full Range|Median
2713702|NCT01147653|Primary|Change in Gross Motor Function Measure 66 (GMFM-66) Score|Change in Gross Motor Function Measure 66 (GMFM-66) Score from Baseline to Year 1. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.|Baseline to Year 1|All enrolled patients were analyzed as randomized from Baseline to Year 1.|||units on a scale||Standard Deviation|Mean
2713703|NCT01147640|Secondary|Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population|Microbiological response is eradication (absence of the baseline pathogen from a suitable intra-abdominal specimen) or presumed eradication (absence of a suitable intra-abdominal specimen to culture at the TOC visit in a subject who is assessed as a clinical cure at TOC)|Test-of-Cure Visit (7-14 days after EOT)|Microbiologically Evaluable: treated subjects, with baseline pathogen susceptible to study drug, complied with protocol|||percentage of subjects||95% Confidence Interval|Number
2713704|NCT01147640|Primary|Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population|Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|Test-of-Cure Visit (7-14 days after End of Therapy [EOT])|mMITT: Treated subjects, with baseline pathogen|||percentage of subjects||95% Confidence Interval|Number
2713705|NCT01147627|Secondary|Safety and Tolerability in Different Groups||48 weeks|||||||
2713706|NCT01147627|Secondary|β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)||48 weeks|||||||
2713707|NCT01147627|Secondary|Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles||48 weeks|||||||
2713708|NCT01147627|Primary|the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks||48 weeks||||percentage of HbA1c||Standard Deviation|Mean
2713709|NCT01147601|Secondary|Compare Treatment Group to Control Group Improvement Assessments|"The proportion of subjects in the treatment group as compared to the placebo control group with at least 50% improvement in the extent of the hemangioma.~The difference between the extent/size of the hemangioma as an outcome measure versus color changes.~Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents."|at 6 months|||||||
2713710|NCT01147601|Primary|Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.|This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.|at 6 months||||Participants|||Count of Participants
2713711|NCT01147497|Secondary|Need for Additional Pain Medications After Insertion of the IUD||assessed one week after insertion|Data were not collected for this outcome measure. The follow-up questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about medication use) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.||||||
2713717|NCT01147497|Primary|Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).|assessed immediately post IUD insertion||||units on a scale||Full Range|Median
2713723|NCT01147458|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.|Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)|Since the study was terminated prematurely for a potential safety signal, and in light of the efficacy analysis, the pharmacodynamic (PD) assessment of uLTE4 was not performed and no data are reportable.||||||
2713724|NCT01147458|Secondary|Plasma Concentration of PF-04191834||Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43|Due to early termination of the study, only a subset of pharmacokinetic (PK) samples, from 10 out of 190 randomized participants, were selected for analysis. These 10 participants were selected based on treatment and treatment sequence.|||ng/mL||Standard Deviation|Mean
2713725|NCT01147458|Secondary|Rescue Medication Use|Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.|Day -7 (Visit 2) up to 28-day follow-up (Visit 10)|Number of subjects analyzed (N) is the number of participants taking rescue mediation.|||Number of pills||Standard Deviation|Mean
2713726|NCT01147458|Secondary|Daily Diary Pain Score During Week 2 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713727|NCT01147458|Secondary|Daily Diary Pain Score During Week 1 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713728|NCT01147458|Secondary|Importance Weighted Total WOMAC Score|Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713729|NCT01147458|Secondary|WOMAC Total Score|The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713730|NCT01147458|Secondary|WOMAC Physical Function Domain Score|The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713731|NCT01147458|Secondary|WOMAC Stiffness Domain Score|The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713732|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713784|NCT01147055|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2713733|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
2713734|NCT01147406|Secondary|Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration|Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).|24 hours|Any subject that received the active IMP or placebo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2713735|NCT01147406|Primary|Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers|Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.|7 Days|Any subject that received active IMP or placebo|||Adverse Events|||Number
2713736|NCT01147393|Primary|The Primary Objective of the Phase II Portion of the Study is to Determine the Anti-tumor Efficacy, as Measured by Response Rate, of Fractionated 90Y-epratutumab IgG Given in Combination With Veltuzumab Anti-CD20 IgG Therapy|||Data were not collected||||||
2713737|NCT01147393|Primary|Safety|||Data was not evaluated||||||
2713738|NCT01147393|Primary|Dose-limiting Toxicity|"NCI CTC version 3.0 is used to grade all adverse events and to provide management guidelines for infusional toxicity. Dose-limiting toxicity (DLT) is defined as follows:~Hematologic: Grade 4 toxicity >7 days, as specified by hemoglobin levels, platelet counts or absolute neutrophil count (ANC) or failure of hemoglobin levels, platelet counts or ANC to recover to Grade 1 levels within 12 weeks of completing the treatment cycle (with the use of RBC and platelet transfusions or growth factors during the 12 weeks if necessary, but at least one week without any support prior to qualifying Grade 1 levels).~Non-Hematologic: Any Grade 3 or Grade 4. Other: Any Grade 2 autoimmune reactions, or the occurrence of Grade 2 immediate-type allergic/hypersensitivity reactions (e.g., urticaria, wheezing, hypoxia and dyspnea) will be considered DLT and will also require the infusion to be permanently terminated.~Occurrence of DLT requires a patient's treatment to be permanently discontinued"||Data were not collected||||||
2713739|NCT01147393|Primary|Determine the Maximum Tolerated 90Y Dose|||Data was not collected||||||
2713740|NCT01147380|Secondary|Anti-HCV Effect of This Treatment (If Applicable)||2 year|||||||
2713741|NCT01147380|Secondary|Anti-HCC Effect of This Treatment||2 year|||||||
2713742|NCT01147380|Secondary|NK Cell Infusion-related Toxicity|To assess NK cell infusion -related toxicity at the bedside. We will monitor the patient and check the vital sign. If any side effect are noticed, we will record and report to the data safety monitoring comittee.|1 year|Participants were devided two group( small and large dose) as described based on the dose of infused cell numbers.|||participants|||Number
2713743|NCT01147380|Primary|Side Effect of Cadaveric Donor Liver NK Cell Infusion|Side effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.|1 year||||participants|||Number
2713744|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
2713745|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.~The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
2713746|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.~Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
2713747|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
2713748|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
2713749|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
2713750|NCT01147341|Secondary|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement..|Baseline to week 12||||participants|||Number
2713751|NCT01147341|Secondary|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.~The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to week 12||||participants|||Number
2713752|NCT01147341|Primary|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale(VAS).~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|From Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing. 30 subjects who completed the 24 week study were included in the efficacy assessment at week 24.|||participants|||Number
2713796|NCT01147055|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2713753|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.~Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing.|||participants|||Number
2713754|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing|||participants|||Number
2713755|NCT01147341|Primary|Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing|||participants|||Number
2713756|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||Units*h/mL||Standard Deviation|Mean
2713757|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Antigen|Plasma samples were used for the determination of antigenic C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||g*h/L||Standard Deviation|Mean
2713758|NCT01147302|Secondary|Time to Maximum Plasma Concentration (Tmax) of C1 INH|Plasma samples were used for the determination of antigenic and functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||hours||Full Range|Median
2713806|NCT01146912|Secondary|Attendance at Appointment|percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011|September-December 2011||||% participants attending appointment|||Number
2713807|NCT01146912|Secondary|Pediatric: Vaccinated at Influenza Clinic|percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011|March 31, 2011|those unvaccinated by the start date for their cohort|||% participant vaccinated at flu clinic|||Number
2713759|NCT01147302|Secondary|Serum Concentrations of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||Units/mL||Standard Deviation|Mean
2713760|NCT01147302|Secondary|Serum Concentrations of C1 Inhibitor (C1 INH) Antigen|Plasma samples were used for the determination of antigenic C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion||||g/L||Standard Deviation|Mean
2713761|NCT01147302|Secondary|Number of Participants With Allograft Failure|Allograft failure was determined by the presence of the following criteria: current renal allograft nephrectomy and/or a clinical determination that the allograft irreversibly and irrevocably ceased functioning.|From the day of enrollment to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
2713762|NCT01147302|Secondary|Number of Deaths||From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
2713763|NCT01147302|Secondary|Number of Participants Who Required Salvage Splenectomy|If necessary, rescue therapy included splenectomy.|From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
2713764|NCT01147302|Secondary|Number of Plasmapheresis Sessions|If necessary, rescue therapy included plasmapheresis. Participating centers used plasmapheresis for desensitization, if necessary, prior to transplant and also for the treatment of acute AMR. Plasmapheresis therapy was performed for the qualifying episode of AMR according to standards at the investigational site and at the discretion of the investigator. Sessions include those prior to first dose. If plasmapheresis therapy occurred on the same day as study drug dosing, study drug was administered after completion of the plasmapheresis session.|From Day 1 through Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||sessions||Standard Deviation|Mean
2713765|NCT01147302|Secondary|Change From Baseline in Creatinine Clearance|Graft function was assessed by measuring creatinine clearance. Creatinine clearance was calculated by the Cockcroft-Gault formula. Baseline was the last value collected prior to first dose of study drug. A positive change from baseline indicates that the clearance rate has increased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||mL/min||Standard Deviation|Mean
2713766|NCT01147302|Secondary|Change From Baseline in Serum Creatinine|Graft function was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Baseline was the last value collected prior to first dose of study drug. A negative change from baseline indicates that serum creatinine levels have decreased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||mg/dL||Standard Deviation|Mean
2713767|NCT01147302|Primary|Change From Baseline in Histopathology Endpoints|"The protocol-specified Day 20 (post-treatment) biopsy was compared to the qualifying biopsy to assess changes in histopathology for light and immunofluorescence microscopy. The Central Pathologist provided the following categorical information from the qualifying biopsy in an AMR Scorecard: C4d Score (0-100), Margination Score (0-100) Glomerulitis Score (0-100), Vasculitis Score (0-100), Glomerulosclerosis Score (0-100), Chronic Glomerulopathy Score (0-100), Interstitial Fibrosis Score (0-100), and the Chronic Vasculitis Score (0-100), with 0 being absence of abnormal histopathology. The qualifying renal allograft biopsy was performed as standard of care (SOC) within 12 months after transplant and prior to screening for this study. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy. A negative change from baseline indicates that histopathology has improved. Endpoint includes subjects with both Qualifying and Day 20 Biopsies."|Within 72 hours prior to first dose of study drug, Day 20|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||scores on a scale||Standard Deviation|Mean
2713783|NCT01147068|Primary|Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.|42 Days|All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.|||percentage of participants||95% Confidence Interval|Number
2713768|NCT01147302|Secondary|Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR)|"The qualifying renal allograft biopsy was performed as standard of care within 12 months after transplant and prior to screening. The qualifying biopsy was used to establish the diagnosis of AMR and was evaluated for all of the following to obtain baseline assessments: the presence of C4d, and monocyte or neutrophil infiltration around the peritubular capillaries (PTCs) and/or glomeruli. The Central Pathologist provided the following information from the qualifying biopsy in an AMR Scorecard: C4d Score, Glomerulitis Score, Vasculitis Score, Glomerulosclerosis Score, Chronic Glomerulopathy Score, Interstitial Fibrosis Score, and the Chronic Vasculitis Score. The Banff AMR Scoring System was used to summarize these scores. Resolution determination was made based on clinical criteria (improvement of serum creatinine ± decrease of DSA titer, and/or increase in urine output) and histopathology. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy."|90 days after start of treatment|The Intent-to-Treat Safety (ITT-S) population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
2713769|NCT01147250|Secondary|Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108|Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.|Baseline to Week 108 (LOCF)|ITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline UACR value. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.|||percent change||Standard Error|Geometric Mean
2713770|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure|All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.|||participants|||Number
2713771|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure|All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.|||participants|||Number
2713772|NCT01147250|Primary|Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.|From randomization up to the end of study (median follow-up of 25 months)|Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization.|||participants|||Number
2713773|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of subjects with pigmentation changes at site of injection at End of Study|24 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713774|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|12 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713775|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|6 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713776|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|2 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713777|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of subjects with keloid formation at the site of injection at End of Study|24 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713778|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|12 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713779|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|6 Weeks|Safety Population|||Percentage (%) of subjects|||Number
2713780|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|2 Weeks|Safety Population|||percentage of participants|||Number
2713781|NCT01147068|Secondary|Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age|Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults|21 Days|All randomized subjects with Day 0 and Day 21 data analyzed by Cincinnati Children's Hospital Medical Center using the intent to treat population and CBER antigen.|||percentage of participants||95% Confidence Interval|Number
2713782|NCT01147068|Secondary|Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.|Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.|Day 0, and Day 42|All randomized subjects who received study vaccine and had Day 0 and Day 42 geometric mean titers. Analysis of results were generated by Southern Research Institute on the overall population using whole virus.|||titer||95% Confidence Interval|Geometric Mean
2713808|NCT01146912|Primary|Influenza Immunization: Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2011|March 31, 2011|Individuals unvaccinated by time intervention start for their cohort|||% participant vaccinated with influenza|||Number
2713785|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC (0 - ∞)]|Molar ratio of metabolite to parent area under the curve from time zero to extrapolated infinite time [MRAUC (0-∞)].|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose) , 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2713786|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
2713787|NCT01147055|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2713788|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2713789|NCT01147055|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of crizotinib metabolite (PF-06260182). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713790|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713791|NCT01147055|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
2713792|NCT01147055|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose CL/F is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2713793|NCT01147055|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2713794|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2713795|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2714209|NCT01143402|Other Pre-specified|Change in Ki67|Correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
2713797|NCT01147055|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2713798|NCT01147042|Primary|Basal and PMA-stimulated O2 Production Detected by Ferricytochrome c Reduction in Neutrophils||21 weeks|Data were not collected.||||||
2713799|NCT01146951|Secondary|Clinical Global Impression of Change (CGIC)|"CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).~The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life.~Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened."|Up to Week 12 of the treatment period|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||participants|||Number
2713800|NCT01146951|Secondary|Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)|"Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].~Seizures analyzed other than tonic-atonic seizures included:~Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure.~The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Percent change||Full Range|Median
2713801|NCT01146951|Secondary|Percent Change in Total Seizure Frequency (Per 28 Days)|Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Percent Change||Full Range|Median
2713802|NCT01146951|Secondary|Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency|50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.|12 weeks|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Participants|||Number
2713803|NCT01146951|Primary|Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)|"The sum of the frequencies of tonic seizures and atonic seizures was defined as the tonic-atonic seizure frequency and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].~The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Percent Change||Full Range|Median
2713804|NCT01146912|Primary|Influenza Immunization: Delayed Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2012|March 31, 2012||||%participants vaccinated with influenza|||Number
2713805|NCT01146912|Primary|Influenza Immunization: Pregnant Women|percentage of pregnant participants with influenza immunization by December 31, 2011|by December 31, 2011||||%participants vaccinated with influenza|||Number
2714210|NCT01143402|Other Pre-specified|Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage|Changes will be assessed by a Wilcoxon test|Up to 5 years|||||||
2713809|NCT01146873|Secondary|Highest Grade ALT After Randomization|Highest grade ALT after randomization. Grading was determined based on the Division of AIDS (2004) Toxicity Tables to grade adverse reactions. Grading scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening).|through 48 weeks post randomization||||number of participants|||Number
2713810|NCT01146873|Secondary|Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization|Percentage of participants with elevated total cholesterol, elevated LDL, abnormal HDL, or abnormal triglycerides at 40 weeks after randomization|40 weeks||||percentage of participants|||Number
2713811|NCT01146873|Secondary|CD4 Cell Percentage at 48 Weeks After Randomization|CD4 Cell Percentage at 48 Weeks After Randomization|48 weeks||||percentage of cells||95% Confidence Interval|Mean
2713812|NCT01146873|Primary|Viral Failure|Probability of viral failure defined as >= 2 HIV RNA measurements >1000 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks||||probability of viral failure||95% Confidence Interval|Mean
2713813|NCT01146873|Primary|Viral Rebound|Probability of viral rebound defined as >=1 HIV RNA measurements >50 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks||||probability of viral rebound||95% Confidence Interval|Mean
2713814|NCT01146860|Secondary|Ultrasonography of Paranasal Sinuses|Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis.|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||percentage of patients|||Number
2713815|NCT01146860|Secondary|Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale|"General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as responders to treatment. Patients whose symptoms are unchanged or deteriorated as classified as non-responders."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||percentage of patients|||Number
2713816|NCT01146860|Secondary|Major Symptom Score Assessed by the Patient|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.~Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.~Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||units on a scale||Standard Error|Mean
2713817|NCT01146860|Secondary|SNOT 20 Symptom Scores|"Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.~range: 0 to 100"|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||units on a scale (range: 0 - 100)||Standard Deviation|Mean
2713818|NCT01146860|Primary|Major Symptom Score (MSS) Assessed by the Investigator|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.~Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.~Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||units on a scale||Standard Error|Mean
2713819|NCT01146834|Secondary|Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant|Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.|20 days post-transplant|Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis.|||Participants|||Count of Participants
2713820|NCT01146834|Secondary|Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant|Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days.|20 days post-transplant|Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis. However, no statistical test can be performed because the outcome proportion was 100% in each group.|||Participants|||Count of Participants
2713821|NCT01146834|Primary|Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.|The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.|36 months|Arm A: 20 patients were enrolled but only 17 were evaluable. Arm C: 23 patients enrolled but only 21 were evaluable. Arm D and Arm E of the study did not accrue any subjects, therefore the number of participants analyzed for this outcome measure is 0 for both arms.|||Participants|||Count of Participants
2713822|NCT01146808|Secondary|Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal||Six months after hepatitis B vaccination (2 years post transplant)||||Participants|||Count of Participants
2713823|NCT01146808|Secondary|Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination||12-18 months post transplant||||Participants|||Count of Participants
2713824|NCT01146808|Primary|Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver|Determined by hepatitis B serologies and viral load.|Standard of care visits post-transplant for 2 years||||Participants|||Count of Participants
2713825|NCT01146782|Secondary|Percent Reduction in Oxygen Desaturation Index (ODI)|Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.|First treatment night||||ODI reduction (% change)||Inter-Quartile Range|Median
2713826|NCT01146782|Secondary|Last Treatment Night Response (AHI Reduction)|Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.|At completion of 28 day home use.|All subjects in primary endpoint cohort with final evaluable treatment PSG.|||AHI reduction (% change)||Inter-Quartile Range|Median
2713827|NCT01146782|Secondary|Adverse Event Rate|Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.|4 weeks|The Safety Cohort consisted of all subjects who participated in at-home use of the device.|||subjects|||Number
2713828|NCT01146782|Primary|Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20|Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.|first treatment night|All subjects in the primary endpoint cohort were analyzed.|||subjects with clinical success|||Number
2713829|NCT01146704|Secondary|Improvement in NAFLD Fibrosis Score|Patients enrolled with a history of NAFLD will be assessed for improvement in NAFLD Fibrosis scoring index and other imaging parameters if performed as standard clinical care.|1 year||2023-12-31|12/2023||||
2713830|NCT01146704|Secondary|Safety Variables: Incidence, Severity and Duration of Adverse Events, Vital Signs, Concomitant Medications and Physical Examination Results.|High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity|Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject.||2023-12-31|12/2023||||
2713831|NCT01146704|Secondary|Efficacy Variables: Nutrition Assessments (FFQ, 3DFR, and Satiety Questionnaire), Anthropometric Profiles (e.g., Waist and Hip Circumferences), Lab and Biochemical Variables (e.g., Insulin, Lipid Levels, HbA1c), Body Composition (Body Fat), Hormone Level|High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity|The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.||2023-12-31|12/2023||||
2713832|NCT01146704|Primary|Change in Body Weight From Baseline to 12 Months|The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet.|The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.||||lbs||Full Range|Mean
2713833|NCT01146665|Secondary|Change in Health Care System Utilization by Youth|The Child and Adolescent Services Assessment (CASA) is a self-report instrument designed to assess the use of community- and hospital-based health and social services. We focused each question so that we collected service use for an alcohol use problem.|3-months post-intervention|Due to the large amount of missing data (at 1-month [52.3%] and 3-months [59.0%] post-intervention) we did not assess change in utilization from baseline to 1- and 3-months post-intervention (pre-specified secondary outcome) as the results would be prone to bias.|||Participants|||Count of Participants
2713834|NCT01146665|Secondary|Change in Health Care System Utilization by Youth|The Child and Adolescent Services Assessment (CASA) is a self-report instrument designed to assess the use of community- and hospital-based health and social services. We focused each question so that we collected service use for an alcohol use problem.|1-month post-intervention|Due to the large amount of missing data (at 1-month [52.3%] and 3-months [59.0%] post-intervention) we did not assess change in utilization from baseline to 1- and 3-months post-intervention (pre-specified secondary outcome) as the results would be prone to bias.|||Participants|||Count of Participants
2713835|NCT01146665|Secondary|Receptivity to Services: Doctors/Counselors Can Help|As part of CASA measure (secondary outcome measure to measure health and social services utilization) adolescents were asked two additional questions on receptivity to receiving services. The data below reflects the second question: On a scale of 1-5, where 1 is it's definitely cannot help and 5 it definitely can help, do you think that doctors or counselors can help with alcohol use problems in general?|Baseline||||Participants|||Count of Participants
2713836|NCT01146665|Secondary|Perceived Barriers to Services|As part of CASA measure (secondary outcome measure to measure health and social services utilization) adolescents answered 8 additional questions on perceived barriers to services: 1) Do you have any feelings such as dislike, distrust or fear about talking with doctors, counselors or other professionals? 2) Do you have any feelings about what other people would think if you sought help? 3) Do you find there is a lack of information that affected health services sought? 4) Do you have any concerns about the amount of time it takes to get help? 5) Were the health services you sought just not readily available? 6) Did you feel you just didn't want to talk to anyone about such a sensitive problem? 7) Was there a problem with registration, setting up appointments or contacting professionals? 8) Was there a problem getting to where treatment was available?|Baseline||||Participants|||Count of Participants
2713837|NCT01146665|Secondary|Receptivity to Receiving Services: Seeking Help/Treatment|As part of CASA measure (secondary outcome measure to measure health and social services utilization) adolescents were asked two additional questions on receptivity to receiving services. The data below reflects the first question: On a scale of 1-5, where 1 is it's definitely a bad idea and 5 it's definitely a good idea, do you think that if someone you knew had an alcohol use problem they should get help or seek treatment?|Baseline||||Participants|||Count of Participants
2713890|NCT01145885|Primary|Ae,Faeces(0-tz) of 14C Radioactivity|Amount of analyte excreted in faeces within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity|Every 24 hours, up to 504 hours|PK set|||nmol||Geometric Coefficient of Variation|Geometric Mean
2713838|NCT01146665|Secondary|Change in Health Care System Utilization by Youth|The Child and Adolescent Services Assessment (CASA) is a self-report instrument designed to assess the use of community- and hospital-based health and social services. We focused each question so that we collected service use for an alcohol use problem.|Baseline|Due to the large amount of missing data (at 1-month [52.3%] and 3-months [59.0%] post-intervention) we did not assess change in utilization from baseline to 1- and 3-months post-intervention (pre-specified secondary outcome) as the results would be prone to bias.|||Participants|||Count of Participants
2713839|NCT01146665|Secondary|PAF Feasibility and Acceptability|The acceptability of the Personalized Assessment Feedback (PAF) intervention will be assessed by youth post-intervention (only youth allocated to the PAF intervention). Measure assessed acceptability (satisfaction with the intervention, perceptions of the helpfulness, credibility of the personalized assessment feedback) and feasibility (time to completion, user friendliness).|youth: post-intervention (day 1)||||Participants|||Count of Participants
2713840|NCT01146665|Secondary|Knowledge of Treatment Allocation||post-intervention (day 1)|Total number of participants analyzed was 44. Each allocation guess by staff/physicians/nurses was analyzed using the number of adolescents allocated to each arm: 18 to intervention; 26 to control.|||Participants|||Count of Participants
2713841|NCT01146665|Secondary|Retention Rates||1 and 3 months post-intervention|We were interested in the overall study retention rates at 1- and 3-months post-intervention, and not retention rates per arm, as the purpose of calculating the rates was to assess the feasibility of a follow-up period in a definitive randomized controlled trial.|||Participants|||Count of Participants
2713842|NCT01146665|Secondary|Recruitment Rate|To be calculated following active recruitment (18 months from study start date of patient enrolment). The recruitment rate relates to recruitment into the study, and not recruitment per arm as randomization and allocation occurred after enrolment.|18 months|The recruitment rate was calculated as the number of enrolled participants (n=44) divided by the number of eligible participants (n=117).|||Participants|||Count of Participants
2713843|NCT01146665|Primary|Change in Youth Alcohol Use|AUDIT-C (Alcohol Use Disorders Identification Test Consumption subscale): 1 item regarding frequency of alcohol consumption, 1 item regarding the amount of alcohol consumption, and 1 item regarding the frequency of binge drinking. Scores range from 0 to 12 with higher scores reflecting more consumption. The change in alcohol use report below reflects the change in AUDIT-C scores with negative values indicating a reduction in score and positive values indicating an increase in score.|baseline, 1 and 3 months post-intervention||||units on a scale||Standard Deviation|Mean
2713844|NCT01146613|Primary|Weekly Percentage of Heavy Drinking Days|Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.|Weeks 2-13*||||percentage of heavy drinking days||Standard Error|Mean
2713845|NCT01146600|Secondary|PSQI|"Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
2713846|NCT01146600|Secondary|SF-36, Vitality Subscale|"The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
2713847|NCT01146600|Secondary|FOSQ|"Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
2713848|NCT01146600|Secondary|Epworth Sleepiness Scale|"Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
2713849|NCT01146600|Secondary|PVT Number of Lapses|Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||Number of lapses||Standard Deviation|Mean
2713850|NCT01146600|Secondary|PVT Median Reaction Time at Week 1|"median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)"|week 1|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||Msec||Standard Deviation|Mean
2714211|NCT01143402|Other Pre-specified|PFS (Group 3)|Evaluated using a Simon mini-max design. Curves will be generated using Kaplan-Meier methodology.|4 months|||||||
2713851|NCT01146600|Primary|Psychomotor Vigilance Task (PVT) Reaction Time|"Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)"|week 2 of each intervention|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||Msec||Standard Deviation|Mean
2713852|NCT01146496|Secondary|Incidence of Unintentional Paediatric Pesticide Poisoning||For three years post intervention||||Participants|||Count of Participants
2713853|NCT01146496|Secondary|Incidence of Pesticide Poisoning||For three years post intervention||||Participants|||Count of Participants
2713854|NCT01146496|Secondary|Incidence of Fatal Self-harm||For three years post intervention||||Participants|||Count of Participants
2713855|NCT01146496|Secondary|Incidence of All Self-harm||For three years after intervention||||Participants|||Count of Participants
2713856|NCT01146496|Secondary|Incidence of All Self-poisoning|Cases of self-poisoning identified|For three years post-intervention||||Participants|||Count of Participants
2713857|NCT01146496|Primary|Incidence of Pesticide Self-poisoning|Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village|For three years after intervention||||Participants|||Count of Participants
2713858|NCT01146457|Primary|Rate of Breakthrough Pain|Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.|Participants were followed for the duration of delivery, an average of 7 hours||||episodes of breakthrough pain per hour||Standard Deviation|Mean
2713859|NCT01146418|Secondary|Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)|The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.|From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)|FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.|||Percentage of Participants||95% Confidence Interval|Number
2713860|NCT01146418|Primary|Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)|The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).|Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)|Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.|||Percentage of Participants||95% Confidence Interval|Number
2713861|NCT01146379|Primary|Change in Action Research Arm Test (ARAT) Score Per Week|The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.|9 weeks||||change in units on a scale/week||Standard Error|Mean
2713862|NCT01146288|Primary|Renal Vascular Resistance (mm Hg/[ml/Min])||baseline and after diuretics administration||||mm Hg/[ml/min]||Standard Deviation|Mean
2713863|NCT01146288|Primary|Change in GFR (ml/Min)||baseline and after diuretics administration||||ml/min||Standard Deviation|Mean
2713864|NCT01146275|Primary|To Evaluate the Long Term Safety of Macrolane in Breast Enhancement|"To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"|7 years +/- 6 months post treatment|Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.|||participants|||Number
2713865|NCT01146275|Primary|To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation|The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.|7 years +/- 6months post treatment|MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.|||participants with remaining product|||Number
2713866|NCT01146054|Secondary|Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up.|"Freedom from local progression is defined as the time from start of SBRT treatment to local progression, with death as a competing risk. If the patient neither died nor experienced local progression, then patient was censored at last follow up.~The data was analyzed in a competing risk model and the outcome reported was the 1 year cumulative incidence rate."|Up to 5 years of follow up.||||Proportion of participants with FFLP||95% Confidence Interval|Number
2713867|NCT01146054|Secondary|To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up.|Time to death was measured from start of treatment to until death. If death was not observed, the patient was censored at last follow up.|Up to 5 years of follow up.|The entire cohort.|||Months||95% Confidence Interval|Median
2713891|NCT01145885|Primary|Ae(0-tz) of 14C Radioactivity in Urine|Amount of analyte eliminated in urine within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity|Every 24 hours, up to 504 hours|PK set|||nmol||Geometric Coefficient of Variation|Geometric Mean
2713868|NCT01146054|Secondary|To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up .|"Time to progression free survival is measured from start of SBRT treatment until first progression event or death, which ever comes first. If the patient did not have an event, then the patient was censored at the last follow up.~The analysis was a Kaplan-Meier curve and the outcome was the median time to progression free survival."|Up to 5 years of follow up.|The whole cohort.|||Months||95% Confidence Interval|Median
2713869|NCT01146054|Secondary|Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment.|Acute grade 2 or greater gastritis, fistula, enteritis, or ulcer or any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.|Within 3 months of treatment.|Whole cohort.|||Number of toxicities.|||Number
2713870|NCT01146054|Primary|To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year.|Grade 2 or greater late gastritis, fistula, enteritis, or ulcer or late grade 3-4 gastrointestinal toxicity at one year.|One year.|The whole cohort was analyzed.|||Number of toxicities.|||Number
2713871|NCT01145898|Primary|3-year Change in OPP|Measurement of change in ocular perfusion pressure|Baseline and 36 month visits||||mm Hg||Standard Error|Mean
2713872|NCT01145898|Primary|3-year Change in CRA RI|Measurement of change in ocular blood flow - central retinal arteries resistance index|Baseline and 36 month visits||||unitless||Standard Error|Mean
2713873|NCT01145898|Primary|3-year Change in CRA EDV|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
2713874|NCT01145898|Primary|3-year Change in CRA PSV|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
2713875|NCT01145898|Primary|3-year Change in OA RI|Measurement of change in ocular blood flow - ophthalmic artery resistance index|Baseline and 36 month visits||||unitless||Standard Error|Mean
2713876|NCT01145898|Primary|3-year Change in OA EDV|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
2713877|NCT01145898|Primary|3-year Change in OA PSV|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
2713878|NCT01145898|Primary|6-month Change in Ocular Perfusion Pressures (OPP)|Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.|Baseline and 6 month visits||||mm Hg||Standard Error|Mean
2713879|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits||||unitless||Standard Error|Mean
2713880|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2713881|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2713882|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits||||unitless||Standard Error|Mean
2713883|NCT01145898|Primary|6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2713884|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
2713885|NCT01145885|Secondary|Percentage of Participants With Clinical Benefit|The endpoint tumour response was was analysed as the percentage of participants with clinical benefit after each treatment cycle based on the Investigator's response assessment (with clinical assessment being conducted after every cycle and radiological assessment at the Investigator's discretion).|21, 42 and 63 days|Treated set|||Percentage of participants|||Number
2713886|NCT01145885|Secondary|Percentage of Participants With Clinically Relevant Abnormalities for Clinical Assessments, ECG, Vital Signs and Laboratory Tests|Percentage of participants with clinically relevant abnormalities for clinical assessments, electrocardiogram (ECG), vital signs and clinical laboratory test parameters. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From first intake of study drug until 21 days after last intake of the study drug, up to 63 days|Treated set|||Percentage of participants|||Number
2713887|NCT01145885|Secondary|Percentage of Participants With Drug Related Adverse Events|Percentage of participants with drug related adverse events (AEs)|From first intake of study drug until 21 days after last intake of the study drug, up to 63 days|Treated set|||Percentage of participants|||Number
2713888|NCT01145885|Primary|Elucidation of Metabolite Structures and Identification of Major Metabolites in Plasma, Urine, and Faeces|"Elucidation of mb structures and identification of major metabolites in plasma, urine, and faeces. This endpoint was not analysed in the study report.~The contribution of volasertib and the metabolite CD 10899 to total radioactivity in plasma in the time interval 0 to 8 h after drug administration supports the suggestion that other metabolites in addition to CD 10899 are present in plasma. However, different methods used for the quantification of volasertib and CD 10899 (HPLC MS/MS) and total 14C-radioactivity (liquid scintillation counting) have to be taken into account for the interpretation of the difference between total 14C-radioactivity and analysis of volasertib and CD 10899 in plasma and the plasma metabolite pattern remains to be categorized."|3 weeks|This endpoint was not analyzed. Please refer to the description for the explanation.||||||
2713889|NCT01145885|Primary|Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity|Time dependency of Cblood cells/Cplasma ratio and Cblood/Cplasma ratio of 14C-radioactivity.|1.983 hours and 6 hours|PK set|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2713957|NCT01145066|Secondary|Pro and Anti-inflammatory Cytokines||4 weeks and 8 weeks combined|No data collected||||||
2713892|NCT01145885|Primary|AUC0-tz of 14C Radioactivity in Plasma and Whole Blood|Area under the concentration-time curve of 14C radioactivity in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz).|30 minutes (min) before start of infusion and 1 hour (h), 1h 59min, 4h, 6h, 8h, 24h, 48h, 96h, 168h and 336h after start of infusion for plasma; 30 min before start of infusion and 1h, 1h 59min, 4h, 6h, 8h and 24h after start of infusion for whole blood|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2713893|NCT01145885|Primary|Ae(0-tz) of Volasertib and CD 10899 in Urine|Amount of analyte eliminated in urine within the time interval 0 hours to last quantifiable data point (Ae(0-tz)) for volasertib and CD 10899, a metabolite of volasertib.|Every 24 hours, up to 504 hours|PK set|||nmol||Geometric Coefficient of Variation|Geometric Mean
2713894|NCT01145885|Primary|CL/R of Volasertib and CD 10899 in Urine|Renal clearance of the analyte in urine (CL/R) within the time interval 0 hours to 504 hours of volasertib and CD 10899, a metabolite of volasertib.|Every 24 hours, up to 504 hours|PK set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2713895|NCT01145885|Primary|AUC0-inf of Volasertib and CD10899 in Plasma|Area under the concentration-time curve of volasertib and CD 10899, a metabolite of volasertib, in plasma over the time interval from 0 to infinity (AUC0-inf).|30 minutes (min) before start of infusion and 1 hour (h), 1h 59min, 4h, 6h, 8h, 24h, 48h, 96h, 168h and 336h after start of infusion|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2713896|NCT01145885|Primary|Cmax of Volasertib and CD 10899 in Plasma|Maximum measured concentration of volasertib and CD 10899, a metabolite of volasertib, in plasma (Cmax).|30 minutes (min) before start of infusion and 1 hour (h), 1h 59min, 4h, 6h, 8h, 24h, 48h, 96h, 168h and 336h after start of infusion|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2713897|NCT01145885|Primary|Rate and Extent of Excretion Mass Balance Based on the Total Radioactivity in Urine and Faeces: Cumulative Fraction of Excretion 504 Hours After Start of Drug Infusion.|Cumulative Percentage of 14C-radioactivity excreted in urine and faeces at 504 hours after start of drug infusion related to total [14C] volasertib administered.|up to 504 hours|PK set|||Percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2713898|NCT01145885|Primary|Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine|Cumulative amounts of CD 10899, a metabolite of volasertib, excreted in urine over time|Every 24 hours, up to 504 hours|PK set|||nmol||Geometric Coefficient of Variation|Geometric Mean
2713899|NCT01145885|Primary|Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine|Percentage of administered dose excreted in urine as volasertib (BI 6727) over time|Every 24 hours, up to 504 hours|PK set|||Percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2713900|NCT01145885|Primary|Individual Time Course Profiles of Volasertib and CD 10899 in Plasma: Cmax of Volasertib and CD 10899 (a Metabolite of Volasertib).|Individual time course profiles of volasertib (BI 6727) and a metabolite of volasertib (CD 10899), in plasma: Cmax of Volasertib and CD 10899.|Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2713901|NCT01145885|Primary|Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces|Percentage of administered dose excreted in faeces as 14C-radioactivity over time|Every 24 hours, up to 504 hours|PK set|||Percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2713902|NCT01145885|Primary|Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine|Percentage of administered dose excreted in urine as 14C-radioactivity over time|Every 24 hours, up to 504 hours|PK set|||Percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2713903|NCT01145885|Primary|Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib|Individual time course profiles of 14C-radioactivity in whole blood and plasma: Cmax of 14C labelled Volasertib.|Whole blood: Pre-dose (-0.5 hours (h)) and 1.0h, 1.983h, 4h, 6h, 8h and 24h after start of the 2h drug infusion.Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.|Pharmacokinetic (PK) set which included all evaluable patients in the treated set who provided at least 1 observation for at least 1 primary PK endpoint and did not undergo important protocol violations relevant to the evaluation of PK parameters.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2713904|NCT01145755|Secondary|MADRS Remission|A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6|6 weeks||||Participants|||Number
2713905|NCT01145755|Secondary|MADRS Response|A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.|6 weeks||||Participants|||Number
2713906|NCT01145755|Primary|MADRS Total Score Change From Baseline to Week 6|Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.|6 weeks||||scores on the scale||Standard Deviation|Mean
2713907|NCT01145638|Secondary|Change in Hemoglobin From Baseline to Week 24||24 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
2713908|NCT01145638|Primary|Change in Hb Concentration||Baseline week 4|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
2713909|NCT01145625|Other Pre-specified|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 52|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.|||hairs per centimeter squared||Standard Deviation|Mean
2713910|NCT01145625|Secondary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography|Baseline to Week 12|Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.|||hairs per centimeter squared||Standard Deviation|Mean
2713911|NCT01145625|Primary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.|||hairs per centimeter squared||Standard Deviation|Mean
2713912|NCT01145560|Secondary|Safety and Tolerability|Number of patients with treatment-emergent adverse events|All study visits (over 90 days following first dose)|Safety Analysis Set|||Participants|||Number
2713913|NCT01145560|Secondary|28-day Mortality|Number of patients who died over 28 days|Over 28 days following first dose|Intention-to-treat analysis set|||Participants|||Number
2713914|NCT01145560|Secondary|7-day Mortality|Number of patients who died over 7 days|Over 7 days following first dose|Intention-to-treat analysis set|||Participants|||Number
2713915|NCT01145560|Primary|Ventilator-free Days (VFDs) Over 28 Days|Number of ventilator-free days (VFDs)|Over 28 days following first dose|Intention-to-treat analysis set|||Days||Full Range|Median
2713916|NCT01145547|Primary|Mean Area Under the Curve for Rise in Breakfast Post-prandial.|Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.|Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast||||min x (mmol/l)||Standard Deviation|Mean
2713917|NCT01145508|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or the date of last known alive.|Assessed every 3 months for 2 years, and then every 6 months for 3 years|All randomized patients are included in the analysis.|||Months||95% Confidence Interval|Median
2713918|NCT01145495|Secondary|Time to Best Response|Kaplan-Meier method will be used.|Up to 10 years|||||||
2713919|NCT01145495|Secondary|Time to Disease Progression|Kaplan-Meier method will be used.|Up to 10 years|||||||
2713920|NCT01145495|Secondary|Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Data will be summarized using frequency tables.|Up to 10 years|||||||
2713921|NCT01145495|Primary|Number of Participants Who Achieved a Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|At 12 months|At the time of analysis, 54 participants had adequate to evaluate response.|||participants|||Number
2713922|NCT01145482|Secondary|Memory|Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance|15 minutes post insulin or placebo administration||||units on a scale||Standard Deviation|Mean
2713923|NCT01145482|Primary|Cerebral Glutamate Concentration|Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.|15 minutes post insulin or placebo administration|per protocol|||ratio||Standard Deviation|Mean
2713924|NCT01145417|Secondary|Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)|"PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated Over past 2 weeks, how often bothered by any of following problems?: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity."|Baseline|SAF population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2713925|NCT01145417|Secondary|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Baseline up to Week 25|SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.|||participants|||Number
2713926|NCT01145417|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2713927|NCT01145417|Secondary|Visual Analogue Scale for Pain (VAS-pain)|Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, 8, 12, 16, 20, 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants who were evaluable at specific time points for each arm group, respectively.|||millimeter (mm)||Standard Deviation|Mean
2713958|NCT01145066|Secondary|Pro and Anti-inflammatory Cytokines||baseline|No data collected||||||
2713959|NCT01145066|Secondary|Serum Fatty Acids|Data at 4 and 8 weeks was averaged.|4 weeks and 8 weeks combined||||percentage of total fatty acids||Standard Deviation|Mean
2713960|NCT01145066|Secondary|Serum Fatty Acids||baseline||||percentage of total fatty acids||Standard Deviation|Mean
2713928|NCT01145417|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Week 24|ITT population included all enrolled participants who took at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific parameter for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
2713929|NCT01145417|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
2713930|NCT01145417|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.|||hours||Standard Deviation|Mean
2713931|NCT01145417|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|"WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded Yes/No to Question 1: Are you currently employed (working for pay)? are reported."|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for each arm group, respectively.|||participants|||Number
2713932|NCT01145417|Primary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study treatment|Safety population (SAF) included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.|||participants|||Number
2713933|NCT01145391|Secondary|Clinical Inertia|"Definition of clinical inertia: failure of a primary care physician to initiate/intensify anti-hypertensive medications AND the failure to provide behavioral counseling to lower blood pressure during a clinic visit where blood pressure is elevated above 140/90 mm Hg. The clinical inertia measure is the percentage of clinic visits with clinical inertia present divided by the total number of clinic visits.~We report a change in group mean levels of clinical inertia from baseline to 9 months post-randomization. Negative values for clinical inertia represent a decrease in the percentage of clinic visits where clinical inertia was present. Pre-randomization clinical inertia was assessed in the last 2 clinic visits prior to randomization, and post-randomization inertia was assessed in the first 2 post-randomization visits.~Hypothesis: clinical inertia will be significantly greater in the usual care compared with intervention group in the post-randomization period."|Baseline, 9 months||||% visits with inertia present||95% Confidence Interval|Number
2713934|NCT01145391|Primary|Blood Pressure|Hypothesis: compared with patients who receive usual care, patients who receive intervention will have an average systolic blood pressure that is at least 5 points lower 9 months after randomization.|Baseline, 9 months|Intention-to-treat analyses using restricted maximum likelihood (REML) for a repeated measures model with incomplete data (SAS Proc Mixed). As this assumes that the occurrence of missing follow-up data depends only on observed data (i.e., pre-randomization values), we also performed a sensitivity analysis using the method proposed by Little.|||mm Hg||95% Confidence Interval|Mean
2713935|NCT01145352|Secondary|Percentage of Participants With Overall Improvement On Physician's Assessment.|Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.|||percent||95% Confidence Interval|Number
2713961|NCT01145066|Primary|Leptin|Data at 4 and 8 weeks was averaged.|4 weeks and 8 weeks combined||||ng/mL||Standard Deviation|Mean
2713962|NCT01145066|Primary|Leptin||baseline||||ng/mL||Standard Deviation|Mean
2713963|NCT01145066|Primary|hsCRP|Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..|4 weeks and 8 weeks combined||||mg/L||Standard Deviation|Mean
2713936|NCT01145352|Primary|Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
2713937|NCT01145352|Primary|Number of Unlisted Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.|||events|||Number
2713938|NCT01145352|Primary|Number of Participants With Serious Treatment-Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.|||participants|||Number
2713939|NCT01145352|Primary|Number of Participants With Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.|||participants|||Number
2713940|NCT01145222|Secondary|Time to Ready for Discharge|Time of the first of 3 consecutive Aldrete scores ≥ 9|After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9|Analysis Population is the ITT Population|||minutes||Standard Deviation|Mean
2713941|NCT01145222|Secondary|Time to Fully Alert|Time to first of 3 consecutive MOAA/S scores of 5 after the last injection of double-blind study medication|From last injection of double-blind study medication until fully alert criteria are reached|Analysis Population is the ITT Population|||minutes||Standard Deviation|Mean
2713942|NCT01145222|Primary|Success Rates of the Procedure|Success of the procedure is a composite endpoint consisting of: Modified Observer's Assessment for Alertness/Sedation (MOAA/S) scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation|From start of study drug injection to patient discharge|Analysis Population is the ITT Population|||Participants|||Count of Participants
2713943|NCT01145209|Primary|Progression Free Survival Rate 2 Years After Initiation of Induction Therapy|"Death or disease progression defined by the 2008 IWCLL guideline as follows;~Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging~Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which was not previously present~Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5000/ul~Transformation to a more aggressive histology~Occurrence of any cytopenia attributable to CLL. After treatment: the progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 20 g/L (2 g/dL) or to less than 100 g/L (10 g/dL), or by a decrease of platelet counts by more than 50% or to les"|2 years|The analyses included only those subjects who completed the induction period.|||Participants|||Count of Participants
2713944|NCT01145183|Secondary|Adverse Events|Adverse effects were closely monitored during each clinic visit throughout this trial. Vital signs including blood pressure (both pre-medication and post-medication) were measured and documented as were concomitant medications.|Pre- and post study medication||||events|||Number
2713945|NCT01145183|Primary|Percentage of Cocaine Positive Urine Toxicology|Cocaine positive urines|2 weeks blocks throughout study||||percentage of positive urines|||Number
2713946|NCT01145066|Secondary|PBMC Leukotriene Stimulation||4 weeks|No data collected||||||
2713947|NCT01145066|Secondary|PBMC Leukotriene Stimulation||baseline|No data collected||||||
2713948|NCT01145066|Secondary|SNPs in DNA of Selected Genes||4 weeks|No data collected||||||
2713949|NCT01145066|Secondary|SNPs in DNA of Selected Genes||baseline|No data collected||||||
2713950|NCT01145066|Secondary|PBMC Gene Expression||4 weeks|No data collected||||||
2713951|NCT01145066|Secondary|PBMC Gene Expression||baseline|No data collected||||||
2713952|NCT01145066|Secondary|Adipose Derived Cytokines||4 weeks|No data collected||||||
2713953|NCT01145066|Secondary|Hemoglobin Levels|Data at 4 and 8 weeks was averaged.|4 weeks and 8 weeks combined||||mg/dL||Standard Deviation|Mean
2713954|NCT01145066|Secondary|Hemoglobin Levels||baseline||||mg/dL||Standard Deviation|Mean
2713955|NCT01145066|Secondary|Fasting Glucose|Data at 4 and 8 weeks was averaged.|4 weeks and 8 weeks combined||||mg/dL||Standard Deviation|Mean
2713956|NCT01145066|Secondary|Fasting Glucose||baseline||||mg/dL||Standard Deviation|Mean
2713967|NCT01145053|Secondary|Nocturnal Sleep|Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep.|||Units on a scale||Standard Deviation|Mean
2713968|NCT01145053|Secondary|Shortness of Breath|Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath.|||Units on a scale||Standard Deviation|Mean
2713969|NCT01145053|Secondary|Amount of Sputum|Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum.|||Units on a scale||Standard Deviation|Mean
2713970|NCT01145053|Secondary|Cough Frequency|Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency .|||Units on a scale||Standard Deviation|Mean
2713971|NCT01145053|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 .|||L||Standard Deviation|Mean
2713972|NCT01145053|Secondary|Effectiveness|Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.|Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set.|||Patients|||Number
2713973|NCT01145053|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients|||Patients|||Number
2713974|NCT01145001|Secondary|Continuous Abstinence During Treatment|We will also examine continuous abstinence during the six week treatment period by urine analysis each week.|6 weeks|this is the intent to treat group-all starters (not treatment completers)|||consecutive days of abstinence||Standard Deviation|Mean
2713975|NCT01145001|Primary|Abstinence Rates at the End of Treatment|Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.|6 weeks||||percentage of participants not smoking|||Number
2713976|NCT01144949|Secondary|Time to Spontaneous Stone Passage (All Stones)|Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.|4 weeks|ITT population|||days||Standard Error|Mean
2713977|NCT01144949|Primary|Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.|4 weeks|This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm)|||participants|||Number
2713978|NCT01144949|Secondary|Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)|At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.|||units on a scale||Standard Deviation|Mean
2713979|NCT01144949|Secondary|Outpatient Narcotic Analgesic Use for Pain Relief|Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.|4 weeks|ITT population|||Days||Standard Deviation|Mean
2713980|NCT01144949|Secondary|Time to Spontaneous Stone Passage (Distal Stones)|Time to stone passage for distally-located stones is assessed by entries in subject diaries.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.|||days||Standard Error|Mean
2713981|NCT01144949|Primary|Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|"The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography.~For this outcome measure, analysis includes only those stones located in the distal ureter."|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.|||participants|||Number
2713982|NCT01144715|Secondary|Stroke Impact Scale (SIS)|Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.|End of treatment at 8 weeks post enrolment||||units on a scale||Standard Deviation|Mean
2713983|NCT01144715|Secondary|Fugl-Meyer Upper Extremity Test|Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.|End of Treatment at 8 weeks post enrolment||||units on a scale||Standard Deviation|Mean
2713984|NCT01144715|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.|End of treatment at 8 weeks post enrolment||||Seconds||Standard Deviation|Geometric Mean
2713985|NCT01144715|Primary|Action Research Arm Test (ARAT)|The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.|End of treatment at 8 weeks post enrolment||||units on a scale||Standard Deviation|Mean
2713986|NCT01144663|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.|From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713987|NCT01144663|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.|During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713988|NCT01144663|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713989|NCT01144663|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study (from Day 0 to Month 16)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713990|NCT01144663|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31-days (Days 0-30) post-booster vaccination period|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713991|NCT01144663|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination.|During the 8-day (Days 0-7) post-booster vaccination period|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2714000|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.|||Participants|||Count of Participants
2713992|NCT01144663|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination.~For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2)."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713993|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713994|NCT01144663|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31-days (Days 0-30) post-each primary vaccination dose|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713995|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713996|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-meningococcal booster vaccination period|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.|||Participants|||Count of Participants
2713997|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the primary vaccination doses.|||Participants|||Count of Participants
2713998|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.|||Participants|||Count of Participants
2713999|NCT01144663|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. No data was applicable for the Nimenrix 2 Group, Menjugate Group and NeisVac-C Group since meningococcal vaccine was not given in Dose 2.|||Participants|||Count of Participants
2714001|NCT01144663|Secondary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Titers||95% Confidence Interval|Geometric Mean
2714002|NCT01144663|Secondary|Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value|The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714003|NCT01144663|Secondary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Titers||95% Confidence Interval|Geometric Mean
2714004|NCT01144663|Secondary|Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value|The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714005|NCT01144663|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||µg/mL||95% Confidence Interval|Geometric Mean
2714006|NCT01144663|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values|The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714007|NCT01144663|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||µg/mL||95% Confidence Interval|Geometric Mean
2714008|NCT01144663|Secondary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values|The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714009|NCT01144663|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||mIU/mL||95% Confidence Interval|Geometric Mean
2714010|NCT01144663|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values|The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714011|NCT01144663|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||mIU/mL||95% Confidence Interval|Geometric Mean
2714012|NCT01144663|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values|The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714037|NCT01144637|Secondary|Unsolicited Non-serious AEs: Relationship to Vaccination|Occurrence of unsolicited non-serious AEs by relationship to study vaccine|within 29 days after any vaccination|Full Analysis Set|||events|||Number
2714013|NCT01144663|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2714014|NCT01144663|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value|The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714015|NCT01144663|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2714016|NCT01144663|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value|The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714017|NCT01144663|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||IU/mL||95% Confidence Interval|Geometric Mean
2714018|NCT01144663|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value|The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 μg/mL|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714019|NCT01144663|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||IU/mL||95% Confidence Interval|Geometric Mean
2714020|NCT01144663|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value|The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 μg/mL|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714021|NCT01144663|Secondary|Anti-pneumococcal Serotypes Antibody Concentrations|Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||µg/mL||95% Confidence Interval|Geometric Mean
2714022|NCT01144663|Secondary|Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values|The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714023|NCT01144663|Secondary|Anti-pneumococcal Serotypes Antibody Concentrations|Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||µg/mL||95% Confidence Interval|Geometric Mean
2714038|NCT01144637|Secondary|Unsolicited Non-serious AEs: Intensity|Occurrence of unsolicited non-serious AEs by Intensity|within 29 days after any vaccination|Full Analysis Set|||events|||Number
2714024|NCT01144663|Secondary|Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values|The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.|||Participants|||Count of Participants
2714025|NCT01144663|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).|||Titers||95% Confidence Interval|Geometric Mean
2714026|NCT01144663|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values|The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).|||Participants|||Count of Participants
2714027|NCT01144663|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).|||Titers||95% Confidence Interval|Geometric Mean
2714028|NCT01144663|Secondary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values|The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.|Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).|||Participants|||Count of Participants
2714029|NCT01144663|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).|||Titers||95% Confidence Interval|Geometric Mean
2714030|NCT01144663|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values|The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.|Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).|||Participants|||Count of Participants
2714031|NCT01144663|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Pre-primary vaccination at Month 0|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.|||Titers||95% Confidence Interval|Geometric Mean
2714032|NCT01144663|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values|The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination|Pre-primary vaccination at Month 0|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.|||Participants|||Count of Participants
2714033|NCT01144663|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value|The cut-off value for rSBA-MenC titers was ≥ 1:8.|One month after the final primary vaccination at Month 3|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2)and with the blood sample schedule for Visit 4 (Month 3).|||Participants|||Count of Participants
2714034|NCT01144663|Primary|Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value|The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8|One month after the final primary vaccination at Month 3|The analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all subjects who complied with the protocol, who were administered a vaccine containing rSBA-MenA, rSBA-MenW-135 and rSBA-Y components (i.e. only Group Nimenrix 3 and Nimenrix 2) and with available data for the considered assay and time point.|||Participants|||Count of Participants
2714035|NCT01144637|Secondary|Solicited General AEs|Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2714036|NCT01144637|Secondary|Solicited Local AEs|Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2714040|NCT01144637|Secondary|Cardiac Signs or Symptoms|"Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (Adverse Event of Special Interest (AESI)).~An AESI was defined in this trial as:~Any cardiac sign or symptom developed since the first vaccination~ECG changes determined to be clinically significant~Cardiac enzyme Troponin I >= 2 x ULN (>= Grade 2)"|within 30 weeks|Full Analysis Set|||Participants|||Count of Participants
2714041|NCT01144637|Secondary|Serious Adverse Events|Incidence, relationship and intensity of any Serious Adverse Event (SAE)|within 30 weeks|Full Analysis Set|||Participants|||Count of Participants
2714042|NCT01144637|Secondary|Correlation PRNT vs ELISA Titers|Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers|2 weeks following the second vaccination|Per-protocol Set|||Pearson correlation coefficient||95% Confidence Interval|Number
2714043|NCT01144637|Secondary|ELISA Seroconversion Rate|Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|2 weeks following the second vaccination|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2714044|NCT01144637|Secondary|PRNT Seroconversion Rate|Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|2 weeks following the second vaccination|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2714045|NCT01144637|Secondary|ELISA GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.|2 weeks following the second vaccination|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2714046|NCT01144637|Primary|PRNT GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.|2 weeks following the second vaccination|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2714047|NCT01144624|Secondary|Pharmacodynamic Effects of AZD9773 on TNF-alpha|TNF-alpha levels over approximately 6 days following the first dose|Levels taken at baseline, over the dosing period (up to Day 5/6)|Safety analysis set|||pg/ml||Full Range|Median
2714048|NCT01144624|Primary|Pharmacokinetics of AZD9773|Maximum concentration at steady state (Cmax ss) for serum total and specific fabs|From first dose to last dose (Day 5/6 or at premature treatment discontinuation)|Pharmacokinetic analysis set|||ug/mL||Full Range|Geometric Mean
2714049|NCT01144624|Primary|Safety and Tolerability of AZD9773|Number of patients with treatment-emergent adverse events and number of patients who died over 28 days|28 day study period|Safety analysis set|||Participants|||Number
2714050|NCT01144598|Secondary|Evaluation of Rheumatoid Arthritis Treatments Duration|Time elapsed from onset of symptoms to diagnosis of rheumatoid arthritis (that is, from the first rheumatoid arthritis-related symptoms to diagnosis by a related specialist) and the time elapsed from diagnosis with rheumatoid arthritis to initiation of anti-tumor necrosis factor (anti-TNF) treatment.|Day 1|All participants with available information were included in the analysis.|||Months||Standard Deviation|Mean
2714051|NCT01144598|Secondary|Number of Deformities at Inspection|The number of joint deformities of the study participants.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714052|NCT01144598|Secondary|Sedimentation Rate|The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.|Day 1|All participants with available information were included in the analysis.|||millimeters/hour||Standard Deviation|Mean
2714053|NCT01144598|Secondary|Anti-cyclic Citrullinated Peptide|Anti-cyclic citrullinated peptide (anti-CCP) test results.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714054|NCT01144598|Secondary|Rheumatoid Factor|Rheumatoid factor test results.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714055|NCT01144598|Secondary|Number of Comorbidities|Number of comorbid (coexisting) medical conditions of the study participants.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714056|NCT01144598|Secondary|Stiffness Duration|Participants' duration of morning joint stiffness.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714057|NCT01144598|Secondary|Biologics Usage|Biologic treatments participants were taking for their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714058|NCT01144598|Secondary|Number of Disease Modifying Anti-Rheumatic Drugs|The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714059|NCT01144598|Secondary|Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue|Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.|Day 1|Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2714060|NCT01144598|Secondary|Evaluation of Disease Activity Score 28 (DAS28)|"The DAS28 index measures disease activity in rheumatoid arthritis and is derived from the number of swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 100 mm line from very good to very bad). A higher score indicates worse control of disease. A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity."|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
2714061|NCT01144598|Secondary|Evaluation of Global Rheumatoid Arthritis Severity Scale|Global rheumatoid arthritis severity was assessed by asking the participants to consider all the ways their rheumatoid arthritis affected them and to rate how they were doing on a scale of 0 (very well) to 10 (very poor).|Day 1|All participants with available information were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2714062|NCT01144598|Secondary|Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire|The WPAI evaluates the ability to work and perform regular activities. The scale yields 4 types of scores (range 0 to 100): Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2714063|NCT01144598|Secondary|Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI measures physical function by assessing the ability to perform daily living tasks. Each task is rated from 0 (no difficulty) to 3 (unable to do). The total score ranges from 0 to 3. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2714064|NCT01144598|Primary|Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis|The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).|Day 1|All participants with available information were included in the analysis.|||Months||Standard Deviation|Mean
2714065|NCT01144494|Secondary|Outflow Facility|Calculated from the measurement taken during the day and night. Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants.|6 weeks|"Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants.~some patients were consented but did not participate due to various reasons"|||μL/min||Standard Error|Mean
2714066|NCT01144494|Secondary|Uveoscleral Outflow|Calculated from the modified Goldmann equation using data obtained at 9 am and 11 am. Goldmann equation involves data from aqueous flow, tonography/outflow facility, episcleral venous pressure and IOP. Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants.|6 weeks|"Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants.~some patients were consented but did not participate due to various reasons"|||μL/min||95% Confidence Interval|Mean
2714067|NCT01144494|Secondary|Aqueous Flow|Measured by fluorophotometry during the day and night on 29 participants.|6 weeks|"Measurements were taken in the day and night for each group and analysis was done comparing the difference between and within both groups in the day and night respectively.~some patients were consented but did not participate due to various reasons"|||µl/min||Standard Error|Mean
2714068|NCT01144494|Primary|Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP)|The episcleral venous pressure was measured using the episcleral venomanometer|6 weeks plus 2 days|some patients were consented but did not participate due to various reasons|||mmHg||Standard Error|Mean
2714069|NCT01144494|Primary|Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm|Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm.|6 weeks|some patients were consented but did not participate due to various reasons|||mmHg||Standard Error|Mean
2714070|NCT01144455|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year||||days||95% Confidence Interval|Median
2714071|NCT01144442|Secondary|Overall Survival|Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.|Up to 5 Years|Data was not collected due to the trial and all data collection processes being being terminated.||||||
2714072|NCT01144442|Secondary|Progression-free Survival|Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).|Up to 5 Years (intended)|Data was not collected due to the trial and all data collection processes being being terminated.||||||
2714073|NCT01144442|Secondary|Quality of Life Measurements|The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.|Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27|Data was not collected due to the trial and all data collection processes being being terminated.||||||
2714074|NCT01144442|Primary|Feasibility of HIPC in Recurrent Disease Setting|We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.|6 months||||participants|||Number
2714075|NCT01144442|Primary|Clinical Response|We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.|After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)||||participants|||Number
2714076|NCT01144416|Secondary|Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event|The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.|Up to time of embryo transfer (maximum of 24 days after start of study drug)|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.|||participants|||Number
2714090|NCT01144377|Secondary|Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)|"Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.~Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate."|Baseline, 24 weeks and 52 weeks and 64 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline femoral neck or total hip BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
2714077|NCT01144416|Secondary|Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)|"Grade II (moderate OHSS) is characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea.~Grade III (severe OHSS) is characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm, may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause hemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena."|Up to approximately 1 month after oocyte pick-up|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.|||participants|||Number
2714078|NCT01144416|Secondary|Live Birth Rate|The live-birth rate is the percentage of participants with at least 1 live born infant after an ongoing pregnancy in the controlled ovarian stimulation (COS)treatment cycle relative to the number of participants treated.|Approximately nine months after embryo transfer|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to.|||Percentage of participants|||Number
2714079|NCT01144416|Secondary|Number of Oocytes Retrieved Per Attempt|The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).|Maximally 21 days after the start of study treatment.|Intent-To-Treat (ITT) Group, defined as all randomized participants who received one or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. The number of oocytes retrieved were set to zero for participants who did not have oocyte retrieval.|||Number of oocytes||Standard Deviation|Mean
2714080|NCT01144416|Primary|Percentage of Participants With a Vital Pregnancy|Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle|Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. Participants who did not have embryo transfer or who were lost to follow-up before the ultrasound assessment to confirm vital pregnancy were counted as non-pregnant.|||percentage of participants|||Number
2714081|NCT01144403|Secondary|Number of Participant With Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to 50 months (approximately)|Safety population included all the participants who had received at least one dose of study treatment.|||participants|||Number
2714082|NCT01144403|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.|||days||95% Confidence Interval|Median
2714083|NCT01144403|Secondary|Overall Survival (OS)|Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.|||days||95% Confidence Interval|Median
2714084|NCT01144403|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.|Up to 50 months (approximately)|Efficacy population included all the participants who had received at least one dose of study treatment.|||percentage of participants|||Number
2714085|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline serum N-terminal extension propeptide of type I collagen value.|||nanograms/milliliter||Inter-Quartile Range|Median
2714086|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Osteocalcin||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline osteocalcin value.|||micrograms/liter||Inter-Quartile Range|Median
2714087|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline serum type I collagen fragment value.|||nanograms/milliliter||Inter-Quartile Range|Median
2714088|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline bone-specific alkaline phosphatase value.|||units/liter||Inter-Quartile Range|Median
2714089|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)|"Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate."|Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline total radius of the wrist BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
2714212|NCT01143402|Other Pre-specified|Toxicity According to the National Cancer Institute Common Toxicity Criteria|Toxicity will be reported by type, frequency, and severity. Please see adverse events.|Up to 5 years|||||||
2714091|NCT01144377|Secondary|Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)|"Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.~Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate"|Baseline, 12 weeks and 24 weeks and 64 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
2714092|NCT01144377|Primary|Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)|"Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.~Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate."|Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
2714093|NCT01144364|Secondary|Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months|DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.|Months 12, 24, and 34|ITT Population|||percentage of participants||95% Confidence Interval|Number
2714094|NCT01144364|Secondary|Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months|Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.|Months 12, 24, and 34|ITT Population|||percentage of participants||95% Confidence Interval|Number
2714095|NCT01144364|Secondary|Percentage of Participants With a Molecular Response in the Induction Phase|Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.|Months 5 and 8|IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.|||percentage of participants|||Number
2714096|NCT01144364|Secondary|Percentage of Participants With a Response During the Induction Phase|Participants without a response assessment (due to any reasons) were considered as non-responders.|Months 1 to 8|ITT population.|||percentage of participants|||Number
2714097|NCT01144364|Primary|PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.|12, 24, and 34 months|ITT population|||percentage of participants||95% Confidence Interval|Number
2714098|NCT01144364|Secondary|OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months|OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population|||percentage of participants||95% Confidence Interval|Number
2714099|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants With Death|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.|||percentage of participants|||Number
2714100|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
2714101|NCT01144364|Secondary|Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months|DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.|12, 24, and 36 months|ITT population|||percentage of participants||95% Confidence Interval|Number
2714102|NCT01144364|Secondary|Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months|PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population|||percentage of participants||95% Confidence Interval|Number
2714203|NCT01143610|Primary|Percentage of Root Coverage|Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)|Baseline, 9 months post-operatively|The unity of analysis was the site, since each participant contributed with more than one site for treatment|||percentage of area covered|Participants|Full Range|Mean
2714103|NCT01144364|Primary|Percentage of Participants With Disease Progression or Death|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.|12, 24, and 34 months|ITT population|||percentage of participants|||Number
2714104|NCT01144338|Secondary|Secondary Efficacy Outcome Hospitalization for HF|The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714105|NCT01144338|Secondary|Secondary Efficacy Outcome Hospitalization for ACS|The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714106|NCT01144338|Secondary|Secondary Efficacy Outcome Stroke|Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714107|NCT01144338|Secondary|Secondary Efficacy Outcome MI|Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714108|NCT01144338|Secondary|Secondary Efficacy Outcome CV Death|Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714109|NCT01144338|Secondary|Secondary Efficacy Outcome All-Cause Mortality|The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714110|NCT01144338|Primary|Primary Safety Outcome MACE Events|"The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.~The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo."|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714111|NCT01144338|Primary|Primary Efficacy Outcome MACE Events|"The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.~The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo."|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
2714112|NCT01144299|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (From Day 0 up to Day 21)||||Participants|||Count of Participants
2714113|NCT01144299|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 21-day (Day 0-20) post-vaccination period||||Participants|||Count of Participants
2714114|NCT01144299|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data|||Participants|||Count of Participants
2714115|NCT01144299|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data|||Participants|||Count of Participants
2714116|NCT01144299|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2714117|NCT01144299|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||fold change||95% Confidence Interval|Mean
2714213|NCT01143402|Other Pre-specified|Response Rate (Complete and Partial Response)|Calculated along with a 95% confidence interval.|Up to 5 years|||||||
2714118|NCT01144299|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2714119|NCT01144299|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2714120|NCT01144299|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data|||titer||95% Confidence Interval|Geometric Mean
2714121|NCT01144286|Secondary|Dose-response of Clinical and Mycological (Global)Therapeutic Response|Global therapeutic response at day 8± 2 days. Safety and tolerability.|Day 8 ± 2 days|Dose response tested using logistic regression-linear coefficient for treatment effect.Assuming response rate 80% for 600 mg, 75% for 300 mg, 65% for 150 mg and 50% for the placebo group, sample size of 45 subjects in each group have 90% power to detect linear dose response with 0.05 two-sided test of trend based on the logistic model.|||percentage of cured participants||95% Confidence Interval|Number
2714122|NCT01144286|Primary|Dose-response of Clinical and Mycological (Global) Therapeutic Response|"Global therapeutic response at day 26± 4 days (TOC- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline Vulvovaginal Candidiasis —Developing Antimicrobial Drugs for Treatment."|day 26 ± 4 days|The full analysis set (FAS) was the primary population for the analysis of all efficacy endpoints. The FAS was defined as all randomized subjects who received at least 1 dose of a study drug.Subjects in the FAS were analyzed according to randomized treatment group.|||percentage of patients cured||95% Confidence Interval|Number
2714123|NCT01144182|Secondary|Emotional Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714124|NCT01144182|Primary|Heart Failure Specific Quality of Life|Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the MLHFQ, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714125|NCT01144182|Secondary|Physical Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714126|NCT01144182|Primary|General Quality of Life From the Standardized Physical Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714127|NCT01144182|Secondary|Mental Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714128|NCT01144182|Secondary|Role Emotional|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714129|NCT01144182|Secondary|Social Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714130|NCT01144182|Secondary|Vitality|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714131|NCT01144182|Secondary|General Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714132|NCT01144182|Secondary|Pain Index|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714133|NCT01144182|Secondary|Role Physical|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36. Additionally, a second participant in CBP did not complete the role physical subscale items, leaving a total of 49 in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714134|NCT01144182|Secondary|Physical Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714135|NCT01144182|Secondary|Standardized Mental Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
2714136|NCT01144143|Secondary|Change in Serum SAA Levels Day 0 to Day 56|Serum Amyloid A|Day 0 to Day 56||||ug/ml||Standard Deviation|Mean
2714137|NCT01144143|Secondary|Change in Serum CRP Day 0 to Day 56|Serum measure of systemic inflammation|Day 0 to Day 56||||mg/dl||Standard Deviation|Mean
2714138|NCT01144143|Secondary|Change in Levels of Serum IL-6||Change from Day 0 to Day 56||||pg/ml||Standard Deviation|Mean
2714139|NCT01144143|Secondary|Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee|The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities.|Change from Day 0 to Day 56||||units on a scale||Standard Deviation|Mean
2714140|NCT01144143|Secondary|Change in Joint Effusions From Day 0 to Day 56 Target Knee|"Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive bulge, 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points."|Change from Day 0 to Day 56||||units on a scale||Standard Deviation|Mean
2714141|NCT01144143|Primary|Change in Cellular Infiltrates From Day 0 to Day 28|Cellular infiltration scored 0 to 3|Day 0 to Day 28|In the MPA arm, one subject was excluded from the analysis because their biopsy sample was of insufficient quantity to be processed in the lab.|||Participants|||Count of Participants
2714142|NCT01144052|Secondary|Number of Infections||12 months||||events|||Number
2714143|NCT01144052|Secondary|Number of Patients With Adverse Events|Recording and reporting according to regulations. Monthly assessments or if necessary.|12 months|All patients enrolled and randomized were analyzed.|||participants|||Number
2714144|NCT01144052|Secondary|MRI Parameters|Number of new T2-hyperintense lesions, Number of Gd-enhancing lesions on T1-weighted images. Assessments at month 3, 6, 9, 12, 18, 24.|12 months|All enrolled and randomized patients were analyzed.|||Lesions||Full Range|Median
2714145|NCT01144052|Secondary|Severity of Relapses|Change of Expanded Disability Status Scale (EDSS 1-10). Higher values represent a worser outcome.|12 months vs baseline||||units on a scale||Full Range|Median
2714146|NCT01144052|Secondary|Proportion of Relapse Free Patients||12 months||||participants|||Number
2714147|NCT01144052|Secondary|Number of Relapses||12 months||||number of events|||Number
2714148|NCT01144052|Secondary|Number of Participants With Relapses||12 months|All enrolled and randomized patients were analyzed.|||participants|||Number
2714149|NCT01144052|Primary|Number of Days Until First On-study Relapse|Patients were followed-up during 12 months and time to first on-study relapse from randomization was recorded.|12 months|All enrolled and randomized patients fulfilled the criteria for analysis.|||days||Full Range|Median
2714150|NCT01144026|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|5 weeks|all participants enrolled were analyzed|||ng/mL||Full Range|Median
2714151|NCT01143896|Primary|Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months|The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.|From Baseline to 12 months||||Depression Free Days (DFDs)||Standard Deviation|Mean
2714152|NCT01143896|Primary|Depression Care: Depression Remission|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.|Baseline and 12 months||||participants|||Number
2714153|NCT01143896|Primary|Depression Care: Treatment Response|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.|Baseline and 12 months||||participants|||Number
2714154|NCT01143896|Secondary|Medication Adherence: Medication Possession Ratio|Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day's supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.|12 months||||medication posession ratio||Standard Deviation|Mean
2714155|NCT01143896|Secondary|Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received|Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.|12 months||||proportion of QIs met||Standard Deviation|Mean
2714156|NCT01143896|Primary|Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment|Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.|12 months|intent to treat|||participants|||Number
2714157|NCT01143883|Primary|Surgical Site Infection|We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.|Day of surgery up to 30 days post operatively|The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol|||percentage of participants with SSI|||Number
2714158|NCT01143870|Secondary|Change in Hemoglobin A1C Over 12 Months From Enrollment||12 months|||||||
2714159|NCT01143870|Secondary|The Number of Hemoglobin A1C Values Checked During 6 Month Study Period||6 months|||||||
2714160|NCT01143870|Secondary|Change in Patient Understanding of Disease State|Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention.|2 weeks on average|||||||
2714161|NCT01143870|Primary|Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment||6 months from enrollment||||Percent of glycosylated hemoglobin||Standard Error|Mean
2714162|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in Body Mass Index (BMI)|The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
2714163|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score|The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
2714164|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score|The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
2714165|NCT01143818|Primary|Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score|The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an Aging Male Symptoms (AMS) score available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
2714166|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior six months|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.|||percent days of drug use||Standard Deviation|Mean
2714167|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||percent days of drug use||Standard Deviation|Mean
2714168|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2714169|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2714170|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2714171|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior six months.|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||participants who always used condoms|||Number
2714172|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||participants who always used condoms|||Number
2714173|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||participants who always used condom|||Number
2714174|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||percent days of drug use||Standard Deviation|Mean
2714175|NCT01143766|Secondary|Median Nausea Score at Time of Discharge|Assess the effect of a single 900mg dose of gabapentin on nausea at time of discharge, measured by a visual analog scale ranging from 0 (worst nausea) to 100 (no nausea).|At time of discharge post-procedure||||units on a scale||Inter-Quartile Range|Median
2714176|NCT01143766|Secondary|Median Anxiety Score at Time of Discharge|Assess the effect of a single 900mg dose of gabapentin on anxiety at time of discharge, measured by a visual analog scale ranging from 0 (worst anxiety) to 100 (no anxiety).|At time of discharge post-procedure||||units on a scale||Inter-Quartile Range|Median
2714177|NCT01143766|Secondary|Median Pain Score at Time of Discharge|Assess the effect of a single 900mg dose of gabapentin on pain at time of discharge, measured by a visual analog scale ranging from 0 (worst pain) to 100 (no pain).|At time of discharge post-procedure||||units on a scale||Inter-Quartile Range|Median
2714178|NCT01143766|Secondary|Number of Participants With Sedation-Related Adverse Events|Sedation-related adverse events|At time of discharge post-procedure||||participants|||Number
2714179|NCT01143766|Primary|Dosing Requirements|Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.|At time of discharge post-procedure|TOTAL DOSE OF MEPERIDINE|||TOTAL DOSE OF MEPERIDINE, mg||Inter-Quartile Range|Median
2714180|NCT01143727|Secondary|Percent Change in Wound Area||28 days|Intent-to-Treat|||percentage change from baseline area||Standard Deviation|Mean
2714181|NCT01143727|Primary|Wound Appearance|Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.|28 days|12 subjects initially for this exploratory study. 17 subjects enrolled to ensure 12 evaluable. Intent-to-treat used for primary inference. Missing values imputed by method of population mean (BWAT-m) and last observation carried forward (wound area).|||units on a scale||Standard Deviation|Mean
2714182|NCT01143714|Secondary|Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)||12 weeks|Intent-to-Treat population|||debridements||Standard Error|Least Squares Mean
2714183|NCT01143714|Primary|Change in Wound Area|The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period|4 Weeks|Sample size originally set at 100 to provide 80% power, a=0.05. Interim analysis when enrollment reached 50 indicated results would not change with additional enrollment. Intent-to-treat used for primary inference; Missing values imputed by method of population mean and last observation carried forward (wound area).|||percentage of average change in wound||Standard Error|Least Squares Mean
2714184|NCT01143701|Primary|Teacher-rated ADHD Symptoms|Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Analyses only included patients who had a post-intervention teacher-rated ADHD scale. Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.|||scores on a scale|Participants|Standard Deviation|Mean
2714185|NCT01143701|Primary|Parent-rated ADHD Symptoms|Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.|||scores on a scale|Participants|Standard Deviation|Mean
2714186|NCT01143688|Secondary|Asthma Symptoms|Subjective change in asthma symptoms on a visual-analogue scale with scores ranging from 0 (no positive change) to 10 (complete positive change). These subjective responses were then converted to percent change during the 2 hours by multiplying each score by 10. Each of these individual subject scores were then averaged to produce an average percent change in symptoms.|Assesed over 2 hours during each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.||||percent change in symptoms||Standard Error|Mean
2714187|NCT01143688|Primary|Change in FEV1|The baseline FEV1 (before treatment) was subtracted from the maximum FEV1 recorded during the 2 h period following treatment. This difference value was then converted into percent improvement by dividing by baseline FEV1 and multiplying by 100. Each treatment was given 3 times to each patient, so we averaged the 3 values to yield the mean percent change in FEV1 for each condition.|FEV1 was assessed every 20 minutes for 2 hours at each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.|Each patient went through each treatment arm (albuterol, placebo inhaler, placebo acupuncture, and no-intervention) once in block 1, then again in block 2, and again in block 3, for a total of 12 interventions of the course of the study.|||percentage change in FEV1||Standard Error|Mean
2714204|NCT01143402|Other Pre-specified|FACT-M Total Score|Summarized using descriptive statistics for each assessment time and by treatment group. The scores will be compared between treatment groups using a mixed effect model for repeated measures analysis method. Treatment difference will be estimated from the model for each assessment time.|Up to 5 years|||||||
2714188|NCT01143649|Primary|Cortical Oscillations - EEG|Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.|15 minutes|The brain oscillations measurements were only performed in the tACS study (Experiment 3).|||microVolt^2||Standard Deviation|Mean
2714189|NCT01143649|Primary|Cortical Excitability|"Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham).~The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison."|1 hour|The cortical excitability measurement (MEP) was performed in healthy participants involved in the tDCS+CIMT study (Experiment 2).|||percent change||Standard Deviation|Mean
2714190|NCT01143649|Primary|Jebsen Taylor Hand Function Test|Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.|2 weeks|The Jebsen Taylor Hand Function Test was only performed in the stroke study (Experiment 1).|||seconds||Standard Error|Mean
2714191|NCT01143636|Secondary|Diffuse Noxious Inhibitory Controls - DNIC.|DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).|baseline and at 2 weeks|patients with pelvic pain (Exp. 1).|||lb||Standard Deviation|Mean
2714192|NCT01143636|Secondary|Pain Pressure Threshold Test - PPT|Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).|baseline and at 2 weeks|Patients with pelvic pain (Exp. 1).|||lb||Standard Deviation|Mean
2714193|NCT01143636|Secondary|Von Frey|This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.|baseline and at 2 weeks|Patients with pelvic pain (Exp. 1).|||grams||Standard Deviation|Mean
2714194|NCT01143636|Secondary|Patient Global Assessment - PGA|"This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question how is your health overall on a scale going from 0 to 10 (0 being the worst, 10 being the best)."|2 weeks|Patients with pelvic pain (Exp. 1).|||units on a scale||Standard Deviation|Mean
2714195|NCT01143636|Secondary|Beck Depression Inventory - BDI.|BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).|2 weeks|Patients with pelvic pain (Exp. 1).|||units on a scale||Standard Deviation|Mean
2714196|NCT01143636|Secondary|Mini Mental Scale - MMS|This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.|2 weeks|Patients with pelvic pain (Exp. 1).|||units on a scale||Standard Deviation|Mean
2714197|NCT01143636|Secondary|Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain|The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).|2 weeks|This outcome measure was performed in patients with pelvic pain (Exp 1).|||units on a scale||Standard Deviation|Mean
2714198|NCT01143636|Secondary|Clinical Global Impression - CGI|This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement.|2 weeks|Patients with pelvic pain (Exp 1)|||units on a scale||Standard Deviation|Mean
2714199|NCT01143636|Secondary|Quality of Life Scale (QOLS)|The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL.|2 weeks|We compared active and sham groups (Exp. 1)|||units on a scale||Standard Deviation|Mean
2714200|NCT01143636|Primary|Pressure Pain Threshold|"Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.~The change in pressure pain threshold (post minus pre intervention) is use for the analysis."|baseline and at 2 weeks|The pain pressure test is performed in healthy participants (exp 2).|||lb||Standard Deviation|Mean
2714201|NCT01143636|Primary|Pain Assessment|We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).|baseline and at 2 weeks|The VAS is performed in patients with pelvic pain (Experiment 1).|||units on a scale||Standard Deviation|Mean
2714202|NCT01143610|Secondary|Gain of Clinical Attachment Level|Investigation of clinical attachment level, probing depth and reduction of recession depth|9 months post-operatively|The unit of analysis was the site, since each participant contributed with more than one site to be treated|||mm|Participants|Standard Deviation|Mean
2714214|NCT01143402|Other Pre-specified|Overall Survival|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to death due to any cause, assessed up to 5 years|||||||
2714215|NCT01143402|Other Pre-specified|Objective Disease Progression|per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression|assessed up to 5 years|||||||
2714216|NCT01143402|Secondary|Median Overall Survival (Evaluable Randomized Patients)|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to death due to any cause, assessed up to 5 years||||Months||95% Confidence Interval|Median
2714217|NCT01143402|Primary|Progression-free Survival (PFS) (Evaluable Randomized Patients)|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years|Analysis of progression-free survival in all evaluable randomized patients|||weeks||95% Confidence Interval|Median
2714218|NCT01143389|Secondary|Uncorrected Distance Visual Acuity (UDVA)|Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.|6 months|Per protocol|||logMAR||Standard Deviation|Mean
2714219|NCT01143389|Secondary|Corrected Distance Visual Acuity (CDVA)|Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.|6 months|Per protocol|||logMAR||Standard Deviation|Mean
2714220|NCT01143389|Secondary|Pachymetry|Minimum corneal thickness measured by corneal tomography|6 months|Per protocol|||microns||Standard Deviation|Mean
2714221|NCT01143389|Primary|Change in Maximum Keratometry From Baseline to 6 Months After Treatment|Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.|6 months|Per protocol population|||diopters||Standard Deviation|Mean
2714222|NCT01143337|Secondary|Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ‐DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|LOCF (Week 12 or discontinuation time)||||percentage of change from baseline||Standard Deviation|Mean
2714223|NCT01143337|Secondary|Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|"DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity.~DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.~A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity."|LOCF (Week 12 or discontinuation time)||||units on a scale||Standard Deviation|Mean
2714224|NCT01143337|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response|ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)||||percentage of participants||95% Confidence Interval|Number
2714225|NCT01143337|Secondary|Percentage of Participants Achieving ACR 50 Response|ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)||||percentage of participants||95% Confidence Interval|Number
2714226|NCT01143337|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)||||percentage of participants||95% Confidence Interval|Number
2714227|NCT01143324|Primary|Time to Surgery Recovery Day.|"The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.~Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors."|From date of surgery until date of surgery recovery day assessed up to hospital discharge.||||Days||Standard Deviation|Mean
2714228|NCT01143324|Secondary|Number of Patients That Returned to Work 12months After the Surgery.|Document number of participants that returned to work 12 months after surgery.|12 months after the surgery|The analyzed subjects at 12 months only included the subjects who had available data.|||Participants currently working|||Number
2714229|NCT01143324|Secondary|ODI Difference 12 Months After the Surgery as Compared to Baseline.|Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|Baseline, 12 months|The number of analyzed at 12 months only included subjects who had available data.|||Units on a scale||Standard Deviation|Mean
2714230|NCT01143324|Secondary|Document Adverse Events Occurrence Throughout the Study.|Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.|From Baseline until 12 months||||Number of reported adverse events|||Number
2714231|NCT01143324|Secondary|Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.|Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.|Baseline, 12 months|The number of analyzed at 12 months only included subjects who had available data.|||Participants|||Number
2714232|NCT01143324|Secondary|Proportion of Patients Needing Intervention at Adjacent Level(s).|Proportion of the patients needing intervention at adjacent level(s).|From Baseline until 12 months||||Participants|||Number
2714233|NCT01143324|Secondary|Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).|Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).|From baseline until 12 months||||Participants|||Number
2714234|NCT01143324|Secondary|Number of Patients Who Utilized Rehabilitation Programs|The number of patients who utilized rehabilitation programs was documented (when required).|From 6-12 months after the day of surgery||||participants|||Number
2714235|NCT01143324|Secondary|Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.|Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.|12 months|One hundred and thirty one-level patients (=130 LEVELS) and 24 two-level patients (=48 LEVELS) were assessed for fusion at 12 months per CIP defined criteria.|||Fused levels|Number of levels assessed||Number
2714236|NCT01143324|Secondary|EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.|EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent's self-rated health on a vertical 20 cm VAS where the endpoints are labelled 'Best imaginable health state' at the top and 'Worst imaginable health state' at the bottom, having numeric values of 100 and 0 respectively.|Baseline, 12 months|The number of analyzed at 12 months only included subjects who had available data.|||Units on a scale / Index||Standard Deviation|Mean
2714237|NCT01143324|Secondary|Leg Pain Intensity VAS Score as Compared to Baseline|"Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).~The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months|The number of analyzed at 12 months only included subjects who had available data.|||Units on a scale||Standard Deviation|Mean
2714238|NCT01143324|Secondary|Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.|"Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).~The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months|The number of analyzed at 12 months only included subjects who had available data.|||Units on a scale||Standard Deviation|Mean
2714288|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.|||kg/m^2||Standard Deviation|Mean
2714239|NCT01143324|Primary|Time From Surgery to First Ambulation.|"The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.~Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital."|From date of Surgery to date of First ambulation, assessed up to hospital discharge.||||Days from surgery to first ambulation||Standard Deviation|Mean
2714240|NCT01143272|Secondary|Total Number of Discontinuation or Change of Initially Prescribed Antibiotic||29 months||||participants|||Number
2714241|NCT01143272|Secondary|Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months||||bowel movements per day||Standard Deviation|Mean
2714242|NCT01143272|Secondary|Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months||||days||Standard Deviation|Mean
2714243|NCT01143272|Secondary|Incidence Density of Antibiotic-associated Diarrhea||29 months||||cases per year|||Number
2714244|NCT01143272|Secondary|Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins)||29 months||||episodes|||Number
2714245|NCT01143272|Secondary|Total Number of Clostridium Difficile-associated Diarrhea Episodes||29 months||||episodes|||Number
2714246|NCT01143272|Primary|Total Number of Antibiotic-associated Diarrhea Episodes||29 months||||Episodes|||Number
2714247|NCT01143259|Secondary|Hospital Cost|Total Cost of hospital stay inflation adjusted to 2010 dollars.|Upon discharge|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.|||Dollars||Full Range|Mean
2714248|NCT01143259|Primary|Measure of Improvement Over the Standard|Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.|Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.|||Days in the hospital||Full Range|Mean
2714249|NCT01143207|Primary|MPA Concentration at Day 120 (C120)||day 120 after injection||||ng/mL||Standard Deviation|Mean
2714250|NCT01143207|Primary|MPA Concentration at Day 104 (C104)||day 104 after injection||||ng/mL||Standard Deviation|Mean
2714251|NCT01143207|Primary|MPA Concentration at Day 91 (C91)||day 91 after first injection||||ng/mL||Standard Deviation|Mean
2714252|NCT01143207|Primary|AUC 0-91 (Area Under Curve)||first 91 days following injection||||ng day/mL||Standard Deviation|Mean
2714253|NCT01143207|Primary|Tmax (Time to Cmax)||120 days following injection||||days||Inter-Quartile Range|Median
2714254|NCT01143207|Primary|Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))||120 days following injection||||ng/mL||Standard Deviation|Mean
2714255|NCT01143142|Secondary|Vaccination of Daughter|With mother's consent, daughter's University of Michigan vaccination record will be accessed to determine whether daughter has received any doses of the HPV vaccine. If the University of Michigan vaccination record does not document a visit three months after the intervention, with mother's consent, research staff will call mother at home to determine whether daughter has received any doses of the HPV vaccine.|Less than or equal to three months from the date of the intervention||||participants|||Number
2714256|NCT01143142|Primary|Mother's Intention to Vaccinate Daughter Against HPV|Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention. The scale ranges from 0-11 with higher numbers representing more positive intentions to vaccinate against HPV, and 5 being neutral intentions (i.e. neither positive nor negative). In this assessment we use this 11-point scale to assess vaccination before and after viewing the educational materials. The difference pre and post intervention in vaccination intention is calculated (min 0, max 11) and the mean of these differences are calculated for the control and intervention groups.|Date of intervention (one day)||||units on a scale||Full Range|Mean
2714257|NCT01143090|Secondary|Efficacy|Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289|6 months|||||||
2714258|NCT01143090|Primary|Adverse Events|Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.|6 months|Safety population - One enrolled subject did not receive any study medication and was excluded from this summary.|||participants|||Number
2714259|NCT01143077|Secondary|Tolerability and Safety|Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events|6 Weeks||||participants|||Number
2714260|NCT01143077|Primary|Time to Relapse of Psychotic Symptoms During 6 Weeks|"Relapse is defined as any occurrence of:~Insufficient clinical response~Exacerbation of underlying disease~Discontinuation due to an adverse event"|6 Weeks|Intend to treat|||days||Standard Deviation|Mean
2714261|NCT01143051|Secondary|Number of Subjects With Significant Changes in Laboratory Tests|Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit.|Approximately 6 weeks|Subjects who have taken any amount of study drug treatment. The Arm/Group is presented as one group because subjects would have received all 3 different study drug treatments prior to EOS due to the crossover study design.|||Participants|||Count of Participants
2714381|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
2714262|NCT01143051|Secondary|Number of Subjects With Significant Changes in Physical Examination|Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit.|Approximately 6 weeks|Subjects who have taken any amount of study drug treatment. The Arm/Group is presented as one group because subjects would have received all 3 different study drug treatments prior to EOS due to the crossover study design.|||Participants|||Count of Participants
2714263|NCT01143051|Secondary|Hand Tremor Scores|Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||score on a scale||Standard Deviation|Mean
2714264|NCT01143051|Secondary|Serum Potassium Levels|Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||mmol/L||Standard Deviation|Mean
2714265|NCT01143051|Secondary|Serum Glucose Levels|Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||mg/dL||Standard Deviation|Mean
2714266|NCT01143051|Secondary|ECG: QTc Interval|Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||msec||Standard Deviation|Mean
2714267|NCT01143051|Secondary|ECG: QT Interval|Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||msec||Standard Deviation|Mean
2714268|NCT01143051|Secondary|Vital Signs: Heart Rate (HR)|Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||beats per minute||Standard Deviation|Mean
2714269|NCT01143051|Secondary|Vital Signs: Diastolic Blood Pressure (DBP)|Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||mmHg||Standard Deviation|Mean
2714270|NCT01143051|Secondary|Vital Signs: Systolic Blood Pressure (SBP)|Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.|Pre-dose (baseline) to 360 minutes post-dose|Subjects who have taken any amount of study drug treatment.|||mmHg||Standard Deviation|Mean
2714271|NCT01143051|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 minutes post-dose available and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
2714272|NCT01143051|Primary|Half-life (t1/2) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 min post-dose available; and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Full Range|Mean
2714273|NCT01143051|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Standard Deviation|Mean
2714274|NCT01143051|Primary|Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
2714289|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|12 months|34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.|||mg/dL||Standard Deviation|Mean
2714275|NCT01143051|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg*min/mL||Standard Deviation|Mean
2714276|NCT01143051|Primary|Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
2714277|NCT01143038|Secondary|Number of Participants Who Developed Antibodies to Romiplostim|The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.|Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)|Safety analysis set participants with available results|||participants|||Number
2714278|NCT01143038|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.|From first dose date of romiplostim to end of study (up to 24 months).|Safety analysis set|||participants|||Number
2714279|NCT01143038|Secondary|Percentage of Participants With Splenectomy During the 12-month Treatment Period|If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.|12 months|Safety analysis set|||percentage of participants||95% Confidence Interval|Number
2714280|NCT01143038|Secondary|Percentage of Participants With ITP Remission|ITP remission was defined as maintaining every platelet count ≥ 50 x 10^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.|Up to 24 months|Safety analysis set|||percentage of participants||95% Confidence Interval|Number
2714281|NCT01143038|Primary|Number of Months With Platelet Response During the 12-Month Treatment Period|The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.|12 months|Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.|||months||Standard Error|Mean
2714282|NCT01142947|Primary|Change in Asthma Control Test Score|Patients will be treated with 6 weeks of inhaled beclomethasone diproprionate (BD) treatment and the change in Asthma Control Test (ACT) quantified. The composite ACT score measured at each time point ranged from 5-25 (with higher scores reflective of better asthma control). Therefore, the absolute change in ACT score from before to after treatment could range from -20 to +20.|6 weeks||||change in composite score||Standard Deviation|Mean
2714283|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|12 months|14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2714284|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|6 months|12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2714285|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|Baseline|4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2714286|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|12 months|39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.|||kg/m^2||Standard Deviation|Mean
2714287|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|6 months|30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.|||kg/m^2||Standard Deviation|Mean
2714290|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|6 months|29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.|||mg/dL||Standard Deviation|Mean
2714291|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|Baseline|4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.|||mg/dL||Standard Deviation|Mean
2714292|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|12 months|35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.|||participants|||Number
2714293|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|6 months|28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.|||participants|||Number
2714294|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.|||participants|||Number
2714295|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|12 months|43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.|||% 10 yr Risk||Standard Deviation|Mean
2714296|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|6 months|29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.|||% 10 yr Risk||Standard Deviation|Mean
2714297|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
2714298|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
2714299|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.|||mmHg||Standard Deviation|Mean
2714300|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
2714301|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
2714302|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.|||mmHg||Standard Deviation|Mean
2714330|NCT01142596|Primary|Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52|The percentage of participants with abnormal ECG findings is reported for three time points: 6-week double-blind study P06124 baseline, extension study P06125 baseline and extension study Week 52.|Study P06124 baseline and P06125 study baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug|||percentage of participants|||Number
2714303|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|Baseline|Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.|||% 10 yr Risk||Standard Deviation|Mean
2714304|NCT01142791|Primary|Percent Occurrence of Chronic Leg Pain|The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit > 0.90 was considered statistically successful.|From treatment to 1-month post-treatment|Per protocol the number of participants analyzed was the number of participants receiving more than one sonication. Six subjects receiving one sonication were excluded from the primary analysis but included in the safety population for a safety sample size n = 121.|||percentage of subjects without leg pain||95% Confidence Interval|Number
2714305|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Start of re-exposure period to 56 days post last dose, up to Month 30|All treated participants entering the Re-exposure Period and having measurements available were analyzed. n=evaluable. Treatment groups represent Treatment received during Treatment Period.|||participants|||Number
2714306|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase (GGT) (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of study drug in the Treatment Period, entered the Withdrawal Period, and had values available. n=number evaluable|||participants|||Number
2714307|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Re-exposure Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.|First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days|Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.|||participants|||Number
2714308|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Withdrawal Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes events with an onset date on or after 57 days post last dosing day (active abatacept or active MTX whichever is the later) in the Treatment Period and up to end of Withdrawal Period. Treatment groups represent treatment received during the Treatment Period.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period and entered the Withdrawal Period. Treatment groups represent treatment during the TP.|||participants|||Number
2714309|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Includes data up to last active dose date +56 days if the participant discontinued the Treatment Period or did not enter the Withdrawal Period, up to the day of discontinuation in the Withdrawal Period for participants discontinuing the Withdrawal Period without entering the Re-exposure Period (RP), up to Day 729 visit (Month 24) for participants who complete the Withdrawal Period, and up to 56 days post last active dose in Re-exposure Period for participants entering the Re-exposure Period.|Day 1 to 56 days post last dose in the study, up to Month 30|All randomized participants who received at least 1 dose of study medication were analyzed.|||participants|||Number
2714310|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity. Percent=number with remission/number evaluated (ITT)|Randomization to Month 24|ITT analysis population: Included all randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Participants were grouped according to the treatment regimen to which they were randomized.N= number evaluated.|||percentage of participants||95% Confidence Interval|Number
2714311|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12|WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.). Percentage= number of participants with remission divided by number of participants who were analyzed (all treated participants who were in remission at end of treatment period and entered the Withdrawal Period)|End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)|Treated participants who were in remission at Month 12 (DAS28-CRP<2.6) and entered the Withdrawal Period were analyzed.( N=number of participants analyzed).|||percentage of participants||95% Confidence Interval|Number
2714312|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period|Lower limit of normal (LLN); Upper limit of normal (ULN); Pretreatment (preRX). Criteria for marked abnormality: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Participants|||Number
2714313|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. AEs of special interest are events potentially associated with the drug or disease under study.|Day 1 to 56 days following last dosing day (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period|||Participants|||Number
2714314|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period|||Participants|||Number
2714315|NCT01142726|Secondary|Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)|TP=treatment period; WP=withdrawal period. Change from Baseline=Postbaseline-baseline value. MRI was used to assess joint damage progression at Months 6, 12, and 18. If >20% of joints with a missing score for a parameter (erosion, osteitis, and synovitis), the MRI score of each parameter was considered missing. If ≤20% of joints had a missing score for a parameter, the MRI score for that parameter from the missing joints was carried forward from the previous MRI assessment, or carried backward from the next MRI assessment, if missing score occurred at baseline. MRI total score ranged from 0 (best outcome) to 4 (worst outcome). A gadolinium-enhanced MRI of the dominant hand-wrist was performed on all randomized patients at 5 points. The hand/wrist assessed to have more synovitis was selected initially and used for all subsequent evaluations. The MRI examination was standardized to ensure sufficient image quality for the evaluation of radiographic progression of rheumatoid arthritis.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=the number of patients with both baseline and postbaseline measurements.|||Units on a scale||Standard Error|Mean
2714316|NCT01142726|Secondary|Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)|TP=treatment period; WP=withdrawal period. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|Randomization to Months 6, 12, and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Units on a scale||Standard Error|Mean
2714317|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Units on a scale||Standard Error|Mean
2714318|NCT01142726|Secondary|Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time|HAQ response defined as a reduction of at least 0.3 units from baseline in score on the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2714319|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time|TP=treatment period; WP=withdrawal period. The SDAI is the simple linear sum of 5 outcome parameters: swollen joint count (SJC) and tender joint count (TJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SJC is assessed and recorded at each visit, with no swelling=0, swelling=1 (higher score indicates greater swelling). TJC is assessed at each visit through identification of joints that are painful under pressure or to passive motion, with no tenderness=0, tenderness=1 (higher score indicates greater affection due to disease activity)..|Randomization to Month 18|Intent to Treat (ITT) population. n= number of participants with both post baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
2714320|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Months 12 and 18, and b=number of patients in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2714321|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18|TP=treatment period; WP=withdrawal period. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Baseline to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Units on a scale||Standard Error|Mean
2714362|NCT01142336|Primary|Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year|CSF Aβ42 concentration were measured at baseline and after 1-year intervention.|1-year change of CSF Aβ42 from baseline|"In the Placebo group, 1 participant was dropped due to AE and 1 was lost to follow-up.~In the Simvastatin group, 1 participant was dropped due to AE. These 3 participants were not included in the primary analysis per analysis plan.~All these 3 subjects were not included in the primary analysis based on our per protocol analysis plan."|||1-yr change, pg/ml||Standard Deviation|Mean
2714322|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis (intent to treat).|||Percentage of participants||95% Confidence Interval|Number
2714323|NCT01142726|Secondary|Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind monotherapy in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable|||Percentage of participants||95% Confidence Interval|Number
2714324|NCT01142726|Primary|Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|DAS28-CRP remission defined as <2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable|||Percentage of participants|||Number
2714325|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months||||participants|||Number
2714326|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months||||participants|||Number
2714327|NCT01142596|Primary|Median Time to Loss of Effect in Non-Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Non-Responders, participants without ≥30% decrease from study P06124 baseline in PANSS Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant's schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Non-Responders|||days||95% Confidence Interval|Median
2714328|NCT01142596|Primary|Median Time to Loss of Effect in Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Responders, participants with ≥30% decrease from study P06124 baseline in Positive and Negative Syndrome Scale (PANSS, schizophrenia symptom scale) Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant's schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Responders|||days||95% Confidence Interval|Median
2714329|NCT01142596|Primary|Number of Participants Who Took Antiparkinsonian Drugs|This measure presents the number of participants who used antiparkinsonian drugs started on or after the start of study treatment in extension study P06125. Antiparkinsonian drugs were defined as those categorized into the N04 code (antiparkinson drugs) of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system.|P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
2714331|NCT01142596|Primary|Number of Participants With Non-serious AEs|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. This measure presents the number of participants with at least one AEs that was non-serious (i.e., was not determined to be an SAE).|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
2714332|NCT01142596|Primary|Number of Participants With Serious Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. A serious AE (SAE) is any AE occurring at any dose that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, an important medical event that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when it may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
2714333|NCT01142596|Primary|Change From Study P06125 Baseline in Prolactin at Week 52|For each participant, change in prolactin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||μg/L||Standard Deviation|Mean
2714334|NCT01142596|Primary|Change From Study P06124 Baseline in Prolactin at Week 52|For each participant, change in prolactin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||μg/L||Standard Deviation|Mean
2714335|NCT01142596|Primary|Change From Study P06125 Baseline in Insulin at Week 52|For each participant, change in insulin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||μIU/mL||Standard Deviation|Mean
2714336|NCT01142596|Primary|Change From Study P06124 Baseline in Insulin at Week 52|For each participant, change in insulin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||μIU/mL||Standard Deviation|Mean
2714337|NCT01142596|Primary|Change From Study P06125 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||mmol/L||Standard Deviation|Mean
2714338|NCT01142596|Primary|Change From Study P06124 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||mmol/L||Standard Deviation|Mean
2714339|NCT01142596|Primary|Change From Study P06125 Baseline in HbA1c at Week 52|For each participant, change in HbA1c from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||percentage of HbA1c||Standard Deviation|Mean
2714340|NCT01142596|Primary|Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|For each participant, change in HbA1c from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||percentage of HbA1c||Standard Deviation|Mean
2714341|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment|||score on a scale||Standard Deviation|Mean
2714382|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
2714342|NCT01142596|Primary|Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment|||score on a scale||Standard Deviation|Mean
2714343|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint|Change in DIEPSS Total Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment|||score on a scale||Standard Deviation|Mean
2714344|NCT01142596|Primary|Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint|Change in DIEPSS Total Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment|||score on a scale||Standard Deviation|Mean
2714345|NCT01142596|Primary|Number of Participants With Extrapyramidal Symptoms|"This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for extrapyramidal syndrome were treated as extrapyramidal symptoms."|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
2714346|NCT01142596|Primary|Change From Study P06125 Baseline in BMI at Week 52|For each participant, change in BMI from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||kg/m^2||Standard Deviation|Mean
2714347|NCT01142596|Primary|Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52|For each participant, change in BMI from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||kg/m^2||Standard Deviation|Mean
2714348|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment|For each participant, change in weight from extension study P06125 baseline to the final assessment of extension study was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and final assessment|||percentage of participants in category|||Number
2714349|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment|For each participant, change in weight from preceding 6-week double-blind Study P06124 baseline to the final assessment of extension study P06125 was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 final assessment|||percentage of participants in category|||Number
2714379|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percentage of participants|||Number
2714350|NCT01142466|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline to Week 96|Safety population included all participants all randomized participants of the active treatment group who received at least 1 injection and all randomized participants of the ‘No Treatment’ group, provided that any post-baseline data was available.|||participants|||Number
2714351|NCT01142466|Secondary|Mean Changes in Expanded Disability Status Scale (EDSS) Score From Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5.|Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2714352|NCT01142466|Secondary|Absolute Changes in the Number of T2 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T2 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||T2 lesions||Standard Deviation|Mean
2714353|NCT01142466|Secondary|Absolute Changes in the Number of T1-Gadolinium (T1-Gd) Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|The data was not evaluated due to the small sample size available for this parameter.||||||
2714354|NCT01142466|Secondary|Absolute Changes in the Number of T1 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||T1 lesions||Standard Deviation|Mean
2714355|NCT01142466|Secondary|Number of Relapse-free Participants|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment.|||participants|||Number
2714356|NCT01142466|Primary|Time From Baseline to First Multiple Sclerosis Relapse (in Weeks)|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|Intent-to-treat (ITT) population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. Time to relapse was documented for participants who had at least 1 relapse during the study period.|||weeks||Standard Deviation|Mean
2714357|NCT01142388|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years|Eligible patients|||percentage of participants||90% Confidence Interval|Number
2714358|NCT01142388|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood's formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients|||months||90% Confidence Interval|Median
2714359|NCT01142388|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was counted as an event, or in the case of death within 4 months of randomization in the absence of disease evaluation before that time. PFS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood's formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients.|||months||90% Confidence Interval|Median
2714360|NCT01142336|Primary|Change From Baseline in CSF ptau181 at 1 Year|ptau 181 measured in CSF at baseline and after 1-year intervention|1-year change from baseline||||1-yr change (final - baseline), pg/ml||Standard Deviation|Mean
2714361|NCT01142336|Primary|Change From Baseline in CSF Total Tau at 1 Year|CSF total tau was measured at baseline and after 1-year of intervention|1-yr change|"In the Placebo group, 1 participant was dropped due to AE and 1 was lost to follow-up.~In the Simvastatin group, 1 participant was dropped due to AE. These 3 participants were not included in the primary analysis per analysis plan.~All these 3 subjects were not included in the primary analysis based on our per protocol analysis plan."|||pg/ml||Standard Deviation|Mean
2714380|NCT01142193|Primary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percent Reduction||Full Range|Median
2714363|NCT01142323|Secondary|Mayo Risk Score for Primary Sclerosing Cholangitis|"The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score.~MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values).~Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk.~There is no known range for this score."|6 months|Median baseline MRS was compared to Median MRS after 6 months of study drug|||score||Full Range|Median
2714364|NCT01142323|Primary|Serum Alkaline Phosphatase|Serum alkaline phosphatase will be measured at entry and end of study|6 months||||U/L||Standard Error|Median
2714365|NCT01142310|Primary|The Rey Auditory Verbal Learning Test (RAVLT)|The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. A higher score reflects better performance.|48 weeks||||T Score||Standard Deviation|Mean
2714366|NCT01142297|Secondary|Clinical Success of Implants||1 year|Data were not collected||||||
2714367|NCT01142297|Primary|Implant Stability Quotient (ISQ)|resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.|4 months||||units on a scale||Standard Error|Mean
2714368|NCT01142232|Secondary|Phase II: Treatment-Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.|up to 5 years|All Phase II patients who received treatment.|||Participants|||Count of Participants
2714369|NCT01142232|Primary|Phase II: Overall Response Rate|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better (CR+sCR+VGPR+PR). The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for Multiple Myeloma (CR= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow; sCR=CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunoflurorescence; VGPR=Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component<100 mg per 24 h; PR=>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by >=90% or to <200mg per 24 h).|up to 5 years|All Phase II patients who received at least one dose of study drug and had at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
2714370|NCT01142232|Primary|Phase I: Number of Patients With Dose Limiting Toxicity|The number of patients who had a DLT during the dose finding portion (Phase I) of the trial for the safety of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma.|up to 1 month|All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit (16 patients)|||Participants|||Count of Participants
2714371|NCT01142193|Secondary|Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.|||Percentage of participants|||Number
2714372|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.|||Percent Reduction||Full Range|Median
2714373|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.|||Percentage of participants|||Number
2714374|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percentage of participants|||Number
2714375|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percentage of participants|||Number
2714376|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percent Reduction||Full Range|Median
2714377|NCT01142193|Secondary|Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percent Reduction||Full Range|Median
2714378|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)||||Percentage of participants|||Number
2714385|NCT01142115|Secondary|Haematuria|"Negative or positive result on a multistix urin analysis.~Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter."|2 hours after catheterisation at visits 1 and 2|ITT|||participants|||Number
2714386|NCT01142115|Secondary|Visible Blood|"Visual blood observed on the catheter or in the urine in connection to catheterization.~The nurse who conducted the catheterization could answer yes or no as follows:~Yes = visible blood observed. No = no visible blood observed."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||participants|||Number
2714387|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Withdrawal Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.~There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||participants|||Number
2714388|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Insertion Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.~There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||participants|||Number
2714389|NCT01142115|Secondary|Irritation During Voiding After Catheterization|"After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.~Yes - they experienced irritation. No - they did not experience irritation."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||Participants|||Number
2714390|NCT01142115|Primary|Discomfort Measured on the Visual Analog Scale (VAS)|"Outcome measured on a 10 cm Visual Analog Scale ranging from no discomfort (0cm) to worst thinkable discomfort (10cm)."|10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1|Intention to Treat (ITT) population|||cm||Standard Deviation|Mean
2714391|NCT01142089|Secondary|Clinical Cure|"Clinical Cure is defined as either of the following:~Passage of two or fewer soft stools and no watery stools, no fever (>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug~Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection"|24 hours|Intent to treat (ITT)|||Participants|||Count of Participants
2714392|NCT01142089|Primary|Time to Last Unformed Stool (TLUS)|"The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner:~Step 1: Identify when the patient achieves Clinical Cure.~Step 2: Moving backwards from this time, identify the time of the last unformed stool.~Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2."|24 hours|"Intent To Treat (ITT). Please note that the 75th percentile was not observed during the 120-hour study period for placebo patients.~The percentile groups indicate the hour at which the appropriate percentage of the patient group had met the primary endpoint i.e. by 72 hours, 75% of Rifamycin SV MMX patients had met the endpoint."|||TLUS (hours)||95% Confidence Interval|Mean
2714393|NCT01141907|Primary|Rehospitalization|Rehospitalization with primary diagnosis of heart failure|3 months post enrollment||||hospital readmisions|||Number
2714394|NCT01141725|Secondary|Disease-free Survival (DFS)|In a five year following, the disease free survival was obtained.|5 years|Data for this Outcome Measure was not collected per dose level and is unavailable.|||days||95% Confidence Interval|Median
2714395|NCT01141725|Primary|Median Survival|In a five year following, the median survival was obtained.|5 years||||months||Full Range|Median
2714396|NCT01141725|Primary|Maximum Tolerated Dose|A bayesian approach to estimate the MTD of bendamustine associated with a CR rate of at least 40% and with <30% grade 3-4 non-haematological toxicity was used (Wathen et al, 2008).The MTD of bendamustine in combination with idarubicin was determined after two cases of grade 3 toxicity were noted in the three patients entered at the 75 mg/m2 dose. The DLTs were congestive heart failure and mucositis in one patient each. Patients subsequent to this were treated at the 60 mg/m2 bendamustine dose.|6 months||||mg/m2|||Number
2714397|NCT01141725|Primary|Incidence of Greater Than or Equal to Grade 3 Toxicity|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0.|Up to day +100 after end of therapy or until the patient received an alternative treatment for leukemia, whatever happens earlier||||Participants|||Count of Participants
2714398|NCT01141725|Primary|Response|Assessed by cytogenetics/fluorescence in situ hybridization (FISH) and flow cytometry of blood and bone marrow samples. The response criteria defined by Cheson et al. will be used in this study. These criteria are: morphologic leukemia-free state; morphologic complete remission (CR); cytogenetic CR (CRc); molecular CR (CRm); morphologic CR with incomplete blood count recovery (CRi); partial remission (PR); treatment failure; recurrence (progressive disease).|6 months||||Participants|||Count of Participants
2714399|NCT01141712|Secondary|Ig and Epstein-Barr Virus (EBV) DNA in Blood|The presence of clonal Ig DNA in plasma will be assessed, as will EBV copy number in plasma and in peripheral blood|Day 100, 180, and 365|No data collected to analyze this outcome measure.||||||
2714400|NCT01141712|Secondary|Microbial Translocation Markers|Level of microbial translocation markers will be determined by nonparametric Mann-Whitney tests comparing the distribution of prior microbial translocation markers between patients.|Day 30 and 100|No data collected to analyze this outcome measure.||||||
2714401|NCT01141712|Secondary|HIV Single-Copy Polymerase Chain Reaction (PCR)|HIV RNA assay will be performed at the specified time points and summarize the assessments of the viral copy number using descriptive statistics.|Baseline, Days 100, 180, 365, and 730|Participants with an undetectable (<50 copies/mL) viral load are not included in this analysis (Baseline = 32, Day 100 = 19, Day 180 = 20, Day 365 = 19, and Day 730 = 21)|||copies/mL||Full Range|Median
2714402|NCT01141712|Secondary|Immunologic Reconstitution|Immunologic Reconstitution will be assessed by quantitative immunoglobulin measurement (IgM, IgG and IgA)|Year 1||||mg/dL||Full Range|Median
2714403|NCT01141712|Secondary|Treatment-Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression. A cumulative incidence curve will be computed along with a 95% confidence interval at 100 days post-transplant.|Day 100||||percentage of participants||95% Confidence Interval|Number
2714404|NCT01141712|Secondary|Number of Participants Experiencing Infections|Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any.|Year 1||||participants|||Number
2714405|NCT01141712|Secondary|Number of Participants Experiencing Toxicity|Toxicities will be defined by using the version 3.0 NCI Common Terminology Criteria for Adverse Events (CTCAE) criteria. Only grade 3 and higher toxicities will be collected.|Year 2||||participants|||Number
2714406|NCT01141712|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1500 neutrophils/μL, Hemoglobin> 10g/dL without transfusion support, and platelets > 100,000/μL|Days 100 and 365||||participants|||Number
2714407|NCT01141712|Secondary|Cumulative Incidence of Platelet Recovery|Platelet recovery is defined as a platelet count greater than 20,000/μL for the first of two consecutive labs with no platelet transfusions 7 days prior.|Day 100||||percentage of participants||95% Confidence Interval|Number
2714408|NCT01141712|Secondary|Cumulative Incidence of Neutrophil Recovery|Neutrophil recovery is defined as two consecutive days of absolute neutrophil count (ANC) > 500 neutrophils/μL following the expected nadir.|Day 28||||percentage of participants||95% Confidence Interval|Number
2714409|NCT01141712|Secondary|Lymphoma Disease-free Survival|This will be assessed in patients with CR. Patients are considered failure for this end point if they die or if they relapse after complete remission. Patients with no history of relapse or death after complete remission are censored at time of last follow up.|Year 2|No data collected to analyze this outcome measure.||||||
2714410|NCT01141712|Secondary|Time to Progression After CR|This will be assessed in patients with CR. Patients are considered failure for this end point if they relapse after complete remission. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|Year 2|No data collected to analyze this outcome measure||||||
2714411|NCT01141712|Secondary|Complete Remission (CR) and/or Partial Response (PR)|The frequencies and proportions of patients who have a CR or PR. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease and no new sites.|Day 100|One participant died at day 64 and was not included in analysis|||participants|||Number
2714412|NCT01141712|Secondary|Progression-Free Survival (PFS)|The time to this event is the time from enrollment until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first. Progression-free survival (PFS) will be estimated using the Kaplan Meier product limit estimator. The PFS probability and confidence interval will be calculated at two years post-transplant.|Year 2||||percentage of participants||95% Confidence Interval|Number
2714413|NCT01141712|Secondary|Relapse/Progression|Relapse is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. Progression is defined as a lymph node with a diameter of the short axis of less than 1.0 cm must increase by >= 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.|Year 2||||percentage of participants||95% Confidence Interval|Number
2714414|NCT01141712|Primary|Overall Survival (OS)|Assess the OS after autologous hematopoietic stem cell transplantation (HCT) for chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin's lymphoma in patients with HIV using BEAM for pre-transplant conditioning. The primary analysis will consist of estimating the 1 year OS probability from the time of transplantation based on the Kaplan-Meier product limit estimator. The 1 year and 2 year OS and confidence interval will be calculated.|Year 1 and 2||||percentage of participants||95% Confidence Interval|Number
2714415|NCT01141660|Secondary|Postanesthesia Recovery Times||After surgery||||minutes||Standard Deviation|Mean
2714416|NCT01141660|Primary|Number of Participants With Laryngospasm||2 years||||Participants|||Number
2714417|NCT01141647|Secondary|Determine Cost-effectiveness.|QALYs are the mean quality adjusted life years per patient for the Supported Employment and Standard Care groups. The QALY is a non-negative number assessing the quality and length of life and not just the crude number of years. The minimum value is 0 representing no improvement in the quality of life or length of life and larger numbers indicate healthier and longer life. Maximum QALYs are limited only by the life span of study participants, but may not exceed 1 (perfect health) in any given year.|24-month phase with face-to-face quarterly interviews|213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.|||years||Standard Deviation|Mean
2714418|NCT01141647|Secondary|Determine Total Cost Per Patient Over 24 Months|Total cost is the mean total cost per patient over 24 months in US dollars. The minimum value is 0 representing no cost in US dollars and larger numbers indicating higher costs in US dollars.|24-month phase with face-to-face quarterly interviews|213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.|||US dollars||Standard Deviation|Mean
2714419|NCT01141647|Secondary|Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.|Level of implementation was assessed by interviewing clinical and vocational providers from the seven sites who were involved in or knowledgeable about the program. Values reported represent the numbers of clinical staff who cited having the VRS integrated on the clinical team, a full-time VRS, leadership support, engagement of staff, resources provided immediately, making adjustments to the implementation to fit with the local context, and having audit and feedback as supporting strong implementation|24-month phase with face-to-face quarterly interviews|Each stage comprised of two site visits. Please note that in the early stage fit of IPS model and audit and feedback were not assessed in either of the site visits, hence a value of zero is entered. Also note that in the late stage obtaining resources, fit of IPS model, and audit and feedback were only assessed at 1/2 of the site visits.|||participants|||Number
2714420|NCT01141647|Secondary|Determine Ongoing Effectiveness of SE Over Time.|This measure is used to evaluate the participants who were both in SCI-VIP and PrOMOTE. It assesses the number of people who obtained CE in SCI-VIP and sustained the same CE through their time in the PrOMOTE study. The cohort of SCI-VIP SE participants in PrOMOTE were analyzed separately from the 213 PrOMOTE participants.|48-month phase with face-to-face quarterly interviews|Number of participants in 24-month SE and 24-month SCI-VIP (previous study).|||participants|||Number
2714422|NCT01141647|Primary|Identify Factors That Predict Employment After SCI.|To model the probability of obtaining CE, we first dichotomized CE as 'yes' or 'no'. The Competitive Employment Rate is reported in Outcome Measure 2. We then used unconditional logistic regression to model the probability of obtaining CE through a univariate modeling approach to determine statistically significant predictors of CE. Statistically significant predictors at the p<0.10 criterion level were then explored in a final multivariate model. Demographic (age, race, marital status, etc.), clinical (severity of injury, comorbidities, time since injury, etc.), barriers and facilitators, and quality of life (depression, Satisfaction with Life, etc.) were considered for modeling. A final model was obtained by including all parameters meeting the p<0.10 criterion into a final multivariate model.|24-month phase with face-to-face quarterly interviews||||Odds Ratio||90% Confidence Interval|Number
2714423|NCT01141608|Secondary|Examination of Additional Health Benefits (in Sleep, Cognitive Function, Mood, Quality of Life and Anhedonia, and Weight Gain)||9 months|||||||
2714424|NCT01141608|Secondary|Drug Use and Related Outcomes During the Entire Course of the Study (i.e., Randomization to 9 Months)||9 months|||||||
2714425|NCT01141608|Secondary|Time to Dropout From Substance Abuse Treatment||12 weeks|||||||
2714426|NCT01141608|Secondary|Drug Use and Related Outcomes for All Substances (Categorized as Alcohol, Cannabinoids, Nicotine, Opioids, or Sedative/Hypnotic/Anxiolytics)||12 weeks|||||||
2714427|NCT01141608|Secondary|Withdrawal Symptoms as Measured by the Stimulant Selective Severity Assessment (SSSA) and Craving as Measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief)||12 weeks|||||||
2714428|NCT01141608|Secondary|Time to Relapse (Defined as Second Positive Urine Test [for Stimulants] and Use of Drugs Established by TLFB)||12 weeks|||||||
2714429|NCT01141608|Primary|Percent Days Abstinent|Percent days of abstinence based on stimulant (i.e., cocaine, methamphetamine, amphetamine, or other stimulant, excluding caffeine and nicotine) use during the 12-week acute phase. Days of abstinence will be measured during days 22-84, since it is anticipated that most individuals will be in a highly structured environment during the first 21 days of the study, and therefore would have little opportunity to use substances (i.e., the groups are not likely to differ during this time period). Measured by the Timeline Follow Back (TLFB) and aided by urine drug screen collected three times/week.|single value calculated based on TLFB data during days 22-84|Mean percent stimulant abstinence days based on Timeline Follow back and Eliminate Contradiction (ELCON) algorithm adjustment.|||Percentage of Days||Standard Deviation|Mean
2714430|NCT01141595|Primary|Preschool Language Scales|Change in the raw score from baseline of the Preschool Language Scales over the 16 week period. The raw score was measured at baseline, 8 weeks and 16 weeks after starting treatment and the change over the 16 week period from baseline to the end of the study was calculated. There was no imputed data and the analysis was as treated. The raw score ranged from 0 to 130. Higher scores indicate better performance.|16 weeks|The number of participants with data available that completed at least the 16 week assessment.|||Raw score units / 16 weeks||Standard Deviation|Mean
2714431|NCT01141569|Secondary|Tumor Control Rate (CR + PR + SD)|Tumor control rate is defined as the sum of objective response rate (CR+PR) and stable disease (SD) rate.|Up to 12 months||||Participants|||Count of Participants
2714432|NCT01141569|Secondary|Rate of Disease Stabilizations|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study|Up to 12 months|Number of patients who had Stable disease|||participants|||Number
2714433|NCT01141569|Secondary|Progression-free Survival Rate|Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 12 months||||months||95% Confidence Interval|Median
2714434|NCT01141569|Secondary|Frequency and Severity of Adverse Events|Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 12 months|Number analyzed is number of participants who experienced the adverse event.|||Participants|||Count of Participants
2714435|NCT01141569|Secondary|Time to Progression|Time to Progression is duration of time from start of treatment to time of progression|Up to 12 months||||months||95% Confidence Interval|Median
2714436|NCT01141569|Primary|Objective Response Rate (PR + CR) Using RECIST|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters"|Up to 12 months|Patients that had PR or CR (Objective response)|||participants|||Number
2714437|NCT01141491|Secondary|Overall Survival|To compare the overall survival over time, to estimate the median and 3-year progression-free survival.|Measured over time||2017-04-30|04/2017||||
2714438|NCT01141491|Primary|Progression Free Survival|"The primary objective is to compare the progression-free survival (PFS) over time.~Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the development of tumor growth or recurrence at any site of the body as determined by the principal investigator at each study site or death from disease"|3-years||||Days||95% Confidence Interval|Median
2714439|NCT01141374|Secondary|Stress Levels(3rd and 4th Evaluation)|Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 and 75 days|75 participants were assessed|||units on a scale||Standard Deviation|Mean
2714440|NCT01141374|Primary|Stress Levels After 4 Sessions (2nd Evaluation)|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 30 days|Of the 109 subjects, four were eliminated for having a low level of stress and 3 for not belonging to nursing staff. Of the 105, 7 didn't appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one did not complete the questionnaire, seven went on vacation or sick leave (2).|||units on a scale||Standard Deviation|Mean
2714441|NCT01141283|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|6 months.|The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during extension phase.|||participants|||Number
2714442|NCT01141205|Secondary|Increase in Blood CD4 T-cell Counts|Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of >100 CD4 Tcell per microliter|up to 6 months post vaccination|Participants minus drop-outs and withdrawn participants|||participants with increased CD4 count|||Number
2714443|NCT01141205|Secondary|Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log|changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log|up to 6 months post immunization|Participants minus drop outs and participants withdrawn by them selves or by the physicians|||participants with lowering of VL|||Number
2714444|NCT01141205|Secondary|Induction of New T-cell Immune Response by the Vaccine|induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (> 50 sfu/mio PBMC).|up to 6 months after last immunisation|Analyzed: Participants minus drop-outs and withdrawn participants. Reported: numbers of participants with a new induced ELISPOT Y-cell immune response to the vaccine peptide epitopes|||ELISPOT responders|||Number
2714445|NCT01141205|Primary|Tolerability and Safety of the Treatment.|"We report here the numbers of participants with vaccine related adverse events degree 3 or 4.~Our goal for safety and tolerability was: Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4."|up to 6 months after end of treatment|Analyzed: number of participants started minus individuals lost to follow up or participants that withdraw. Thus we include the two individuals where the physician stopped his/her participation because of SAE not related to the vaccine or to the placebo. Reported: numbers of participants with vaccina related SAE|||participants|||Number
2714446|NCT01141049|Secondary|Percent Days of Abstinence From Alcohol|During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.|assessed for up to 8 weeks, presented at week 8 of trial||||percent of days abstinent||Standard Deviation|Mean
2714447|NCT01141049|Primary|Percent of Heavy Drinking Days Per Week|percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.|assesed over 8 weeks, presented for week 8 of trial||||percent of heavy drinking days||Standard Deviation|Mean
2714448|NCT01140906|Secondary|Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine|The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms.|Change from Week 8 in DESS total score analyzed at Week 10|All Patients Completed Set (APCS), OC, Analysis of Covariance (ANCOVA)|||units on a scale||Standard Error|Mean
2714449|NCT01140906|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction."|Baseline and Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
2714450|NCT01140906|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
2714451|NCT01140906|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF, Logistic Regression|||percentage of patients|||Number
2714452|NCT01140906|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20||Baseline and Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
2714453|NCT01140906|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
2714454|NCT01140906|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS, last observation carried forward (LOCF), Logistic Regression|||percentage of patients|||Number
2714455|NCT01140906|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS), mixed model for repeated measurements (MMRM)|||units on a scale||Standard Error|Mean
2714456|NCT01140880|Primary|Course Completion|PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.|28-days post initiation|40 participants initiated PEP during the study, of which 30 had evaluable course completion data.|||participants|||Number
2714457|NCT01140880|Primary|Medication Adherence|Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.|Daily throughout medication course|40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).|||proportion|||Number
2714458|NCT01140880|Secondary|Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)|Abstinence will be measured using thrice weekly urine drug screens and self-report|Thrice-weekly for 8 weeks|170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.|||Stimulant-free urinalyses||Standard Deviation|Mean
2714459|NCT01140880|Primary|Time From Exposure to Truvada Initiation|Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.|6-month follow-up|40 participants with evaluable data initiated Truvada during the course of the study.|||hours||Standard Deviation|Mean
2714460|NCT01140867|Secondary|QoL-QOLIE31 (Quality of Life in Epilepsy)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included.|||Units on a Scale||Standard Deviation|Mean
2714461|NCT01140867|Secondary|Responder Rate|The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.|||Percentage of Participants|||Number
2714462|NCT01140867|Secondary|Seizure Free Rate|The percentage of the participants who experienced no seizure during the trial.|16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.|||Percentage of Participants|||Number
2714463|NCT01140867|Primary|Seizure Reduction Rate|The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.|||Percentage of Seizure Reduction Rate||Standard Deviation|Mean
2714464|NCT01140815|Secondary|2-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|2 years|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
2714465|NCT01140815|Secondary|1-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|1 year|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
2714466|NCT01140815|Secondary|4-month Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|4 months|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
2714467|NCT01140815|Secondary|6-week Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|6 weeks|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
2714468|NCT01140815|Secondary|2-year Patient Surveys|Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).|2 years|Patients who were not revised within 2 years and were able to complete a questionnaire did so.|||units on a scale 0-48||Full Range|Mean
2714469|NCT01140815|Secondary|2-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.|2 years||||participants|||Number
2714470|NCT01140815|Secondary|1-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.|1 year||||participants|||Number
2714471|NCT01140815|Secondary|4-month X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.|4 months||||participants|||Number
2714527|NCT01139801|Primary|Rate of Induction To Delivery|To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times|24 hrs|Patients requiring caesarean section excluded from analysis.|||minutes||Standard Deviation|Mean
2714472|NCT01140815|Secondary|6-Week X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.|6 weeks||||participants|||Number
2714473|NCT01140815|Primary|1-year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|1 year||||units on a scale 0-100||Standard Deviation|Mean
2714474|NCT01140815|Primary|4-Month Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|4 months||||units on a scale 0-100||Standard Deviation|Mean
2714475|NCT01140815|Primary|6-Week Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|6 weeks||||units on a scale 0-100||Standard Deviation|Mean
2714476|NCT01140815|Primary|2-Year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|2 years||||units on a scale 0-100||Standard Deviation|Mean
2714477|NCT01140646|Secondary|Number of Patients Who Reported Grade 3 Adverse Events|Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|Week 1 to Week 7|All participants who enrolled to the trial.|||Participants|||Count of Participants
2714478|NCT01140646|Secondary|Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)|The Hot Flash Related Daily Interference Scale (HFRDIS) consists of 10 items on scale of 0 to 10 with 0 represents do not interfere and 10 represents completely interferes. An average of the scores of the 10 individual items was calculated for the HFRDIS total score. Each individual item were reported as individual scores. All scores were transposed to a 0-100 point percentage scale where 100 is the best quality of life (QOL) scores. Change from baseline to week 7 scores was calculated by subtracting the baseline scores from the scores at week 7. The positive change in scores indicates an improvement in QOL and negative change in scores indicates a decline in QOL.|Baseline and Week 7|Includes all participants who initiated the study treatment.|||score on a scale||Standard Deviation|Mean
2714479|NCT01140646|Secondary|Change From Baseline to Week 7 for the Profile of Mood States (POMS)|The Profile of Mood States (POMS) consists of 30 items on scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The POMS was scored according to its specific scoring algorithm resulting in a total score and six subscale scores (anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigor/activity). All scores were transposed to a 0-100 point percentage scale where 100 is the best quality of life (QOL) scores. Change from baseline to week 7 scores was calculated by subtracting the baseline scores from the scores at week 7. The positive change in scores indicates an improvement in QOL and negative change in scores indicates a decline in QOL.|Baseline and Week 7|Includes all participants who initiated the study treatment.|||score on a scale||Standard Deviation|Mean
2714480|NCT01140646|Secondary|Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)|The side effect questionnaire (SEQ) consists of 15 items on a scale of 0 to 10 with 10 represents worse symptoms. Each item were reported as individual scores with all scores transposed to a 0-100 point percentage scale where 100 is the best quality of life (QOL) scores. Change from baseline to week 7 scores was calculated by subtracting the baseline scores from the scores at week 7. The positive change in scores indicates an improvement in QOL and negative change in scores indicates a decline in QOL.|Baseline and Week 7|Includes all participants who initiated the study treatment.|||score on a scale||Standard Deviation|Mean
2714481|NCT01140646|Primary|Percent of Baseline in Average Hot Flash Activity (Score and Frequency)|Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.|From baseline to week 7|Analysis population includes only the subjects who have completed the quality of life self-assessment questionnaire.|||Percent of baseline||95% Confidence Interval|Mean
2714482|NCT01140568|Secondary|Overall Response Rate|How many patients who had decrease in tumor size or complete disappearance of tumor.|5 years|38 patients enrolled, but only 34 received study drug|||Participants|||Count of Participants
2714483|NCT01140568|Primary|Number of Patients Who Had 6-month Progression-free Survival.|how many patients had survived 6 months after receiving study drug|6 months|38 patients were enrolled, but only 34 were treated|||Participants|||Count of Participants
2714484|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy as Measured by the Mean Change in CDASI-activity at 12 Weeks|The CDASI (Cutaneous Dermatomyositis Activity and Severity Index) is a validated instrument to measure skin disease activity in dermatomyositis. A clinically meaningful change is a decrease of 4 points. All missing data are imputed using last observation carried forward. Calculation is performed as the score at 12 weeks minus the score at baseline.|Data collected at baseline at 12 weeks||||units on a scale||Standard Deviation|Mean
2714485|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy, as Measured by the Number of Participants Experiencing a 30% Decreased in the CDASI-a Score at 12 Weeks.|This was an intent to treat analysis--dropouts are considered treatment failures. Missing data at 12 weeks imputed by last observation carried forward.|Data collected at 12 weeks after baseline visit.||||participants|||Number
2714486|NCT01140503|Primary|The Primary Endpoint Analysis Will be Safety, as Measured by the Number of Adverse Events and Serious Adverse Events Occuring During 12 Weeks of Therapy and 4 Weeks of Followup.||16 weeks||||adverse events|||Number
2714487|NCT01140477|Secondary|Visual Acuity|Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||logMAR||Standard Deviation|Mean
2714488|NCT01140477|Secondary|Lens Misalignment|This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||degrees||Standard Deviation|Mean
2714489|NCT01140477|Primary|Percent Reduction in Absolute Cylinder|Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||percentage of intended cylinder reduct||95% Confidence Interval|Mean
2714490|NCT01140360|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Gleevec/Imatinib Mesylate in patients with neurofibromas (NF1). The sum of the longest diameter (LD) for all target lesions will be calculated and reported as the disease measurement. Complete Response (CR) disappearance of target lesions. Partial Response (PR) at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Progressive Disease (PD) at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment. Stable Disease (SD) neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest disease measurement since the treatment started.|1 year|13 participants reached the 1 year evaluation time-point. 6 participants withdrew prior to the 1 year evaluation time-point.|||Participants|||Count of Participants
2714491|NCT01140347|Secondary|Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]|Participants were considered positive for anti-ramucirumab antibodies [anti-drug antibodies (ADA)] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.|Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)|Participants who received at least 1 dose of study drug and had post-treatment ADA analysis.|||participants|||Number
2714492|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 7||1 hour following completion of Cycle 7 (14-day cycles) infusion|Participants who received Cycle 7 of Ram and had Cmax results.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2714493|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 4||1 hour following completion of Cycle 4 (14-day cycles) infusion|Participants who received Cycle 4 of Ram and had Cmax results.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2714494|NCT01140347|Secondary|Maximum Concentration (Cmax) of Ramucirumab, Cycle 1||1 hour following the completion of Cycle 1 (14-day cycle) infusion|Participants who received Cycle 1 of Ram and had Cmax results.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2714495|NCT01140347|Secondary|Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died|The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 37 months)|Participants who received at least 1 dose of study drug.|||participants|||Number
2714496|NCT01140347|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score|The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)|Randomized participants who had an EQ-5D score at baseline and the specified time points.|||units on a scale||Standard Deviation|Mean
2714497|NCT01140347|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)|The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)|Randomized participants who had FHSI-8 at baseline and the specified time points.|||units on a scale||Standard Deviation|Mean
2714498|NCT01140347|Secondary|Time to Radiographic Progression (TTP)|TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=86, Pl=52.|||months||95% Confidence Interval|Median
2714548|NCT01139762|Secondary|Patient Global Impression of Improvement (PGI-I) at 26 Weeks|Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.|||participants|||Number
2714499|NCT01140347|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to <10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) * 100.|Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)|ITT Population: All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2714500|NCT01140347|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=43, Pl=19.|||months||95% Confidence Interval|Median
2714501|NCT01140347|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death from any cause (up to 37 months)|Intent-to-treat (ITT) Population: All randomized participants. Participants censored: Ramucirumab+BSC (Ram)=65, Placebo+BSC (Pl)=58.|||months||95% Confidence Interval|Median
2714502|NCT01140295|Secondary|Proportion of Patients With Abnormal Electrolyte Levels|"The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna.~Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant."|The outcome measure will be assessed once one day after the completion of colonoscopy preparation||||Proportion of patients|||Number
2714503|NCT01140295|Primary|Efficacy of Colon Preparation|Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.|The outcome measure will be assessed once one day after the completion of colonoscopy preparation||||percentage of patients|||Number
2714504|NCT01140191|Secondary|Complete Cure of Index Lesion by Day 100|Number of participants with complete cure of index lesion by day 100. Cure rate is defined as 100% re-epithelialization of an ulcerated lesion|100 days|Analysis per protocol|||Participants|||Count of Participants
2714505|NCT01140191|Secondary|Cures of All Other Lesions|Number of participants with 100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions|100 days|Analysis per protocol|||Participants|||Count of Participants
2714506|NCT01140191|Primary|Number of Participants With No Relapse of Index Lesion Between Nominal Day 60 and 100|Number of participants with no relapses of lesion between 60 and 100 days. Relapse is defined as a 10% or greater increase in the area of ulceration of the index lesion or a shift from 100% re-epithelialization to < 100% re-epithelialization of the index lesion at Day 100 for those subjects that had 100% re-epithelialization of the index lesion at nominal Day 60 or before|60-100 days|Analysis per protocol|||Participants|||Count of Participants
2714507|NCT01140191|Primary|Number of Participants Demonstrating Initial Clinical Improvements|Number of participants with > 50% re-epithelialization of index lesion by Day 60 followed by complete re-epithelialization of index lesion on or before nominal Day 100;|60-100 days|Analysis per protocol|||Participants|||Count of Participants
2714508|NCT01140191|Primary|100% Re-epithelialization of Index Lesion by Nominal Day 60|Number of participants with 100% re-epithelialization of index lesion by nominal Day 60|Day 60|Analysis per protocol|||Participants|||Count of Participants
2714509|NCT01140191|Primary|Number of Adverse Events|Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs|3 months|Analysis was per protocol|||Adverse Events|||Number
2714510|NCT01140061|Primary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 28|The population consisted of all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2714635|NCT01138826|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2714511|NCT01140061|Primary|Number of Participants With an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 14 days after last dose of study drug (up to Day 42)|The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.|||Participants|||Number
2714512|NCT01140061|Primary|Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days|Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis|Day 11|The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.|||nM||Standard Deviation|Mean
2714513|NCT01140061|Primary|Number of Participants With an Adverse Event of Erythema in Part I of the Study|Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 22 in Part 1|The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.|||Participants|||Number
2714514|NCT01140048|Secondary|Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor|"Use of Chronic Asthma Therapy for the period of 12 months prior to the age of 6 years was defined by clinical review of reported concomitant medications.~Prognostic factors for use of chronic asthma therapy at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.|||percentage of participants|||Number
2714515|NCT01140048|Secondary|Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor|"Atopic disorders include allergic rhinitis (AR) and/or atopic dermatitis (AD). Atopic disorders was defined as a positive response to the Epidemiology Questionnaire item In the past 6/12 months, has your child had a problem with sneezing or runny or blocked nose when he/she did not have a cold or the flu? for AR and/or a positive response to both of the following items for AD: Has your child had an itchy rash which was coming and going at any time in the past 6/12 months? and Has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears, or eyes? for the period of 12 months prior to age 6 years.~Prognostic factors for atopic disorders at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.|||percentage of participants|||Number
2714516|NCT01140048|Primary|Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor|"Asthma was defined as a positive response to the Epidemiology Questionnaire item Has your child had wheezing or whistling in the chest in the past 6/12 months? for the period of 12 months prior to age 6 years.~Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.|||percentage of participants|||Number
2714517|NCT01139996|Secondary|Mean Incidence and Duration of Delirium|As assessed by daily CAM score currently used. data were not collected|2 or more years|||||||
2714518|NCT01139996|Secondary|Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo|Hours. data were not collected|2 or more years|||||||
2714519|NCT01139996|Secondary|Incidence and Duration in Hours of Delirium Currently Used|As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected|2 or more years|||||||
2714520|NCT01139996|Primary|Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo|data were not collected|2 or more years|data were not collected||||||
2714521|NCT01139879|Secondary|Healing Rate Per Week|The mean change in area per week for all ulcers|12 weeks|Rate of change in area (healing) for all ulcers on all subjects in area (cm^2)/week|||cm^2/week|Participants|Standard Deviation|Mean
2714522|NCT01139879|Secondary|Incidence of New Ulcers|incidence of new ulcers while on the study surface|12 Weeks||||percentage of participants|||Number
2714523|NCT01139879|Primary|Change From Baseline in Ulcer Surface Area at Week 12|The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.|12 Weeks|Ulcers decreased an average of 7.96 cm^2 (+/- 8.1 cm^2) over the 12 week period|||cm^2|Participants|Standard Deviation|Mean
2714524|NCT01139814|Primary|Evaluation of Major Complications|Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.|Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.||||Participants||95% Confidence Interval|Number
2714525|NCT01139814|Primary|Navigation Performance|Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.|During Procedure||||Successful locations|Participants|95% Confidence Interval|Number
2714526|NCT01139801|Secondary|Delivery Route|To assess for differences in delivery routes|24 hrs||||Participants|||Count of Participants
2714665|NCT01138475|Secondary|Serum Calcium|This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from participant in paricalcitrol|||mg/dL||Standard Error|Mean
2714528|NCT01139775|Secondary|Phase 2: Clinical Benefit Rate: Percentage of Participant Who Achieved a Response of Stable Disease (SD), Partial Response (PR), or Complete Response (CR)|Clinical benefit rate is the best response CR, PR, or SD as classified by the investigators according to the RECIST, v1.1 guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Randomization until date of disease progression or death (up to 6 months after the last participant was randomized)|All randomized Phase 2 participants.|||percentage of participants||90% Confidence Interval|Number
2714529|NCT01139775|Secondary|Phase 2: Proportion of Participants Receiving Maintenance Therapy||Cycle 5|Zero participants analyzed. Treatment with LY2603618 was discontinued after 25 October 2012, data was not collected for analysis of the Phase 2: Proportion of Participants Receiving Maintenance Therapy.||||||
2714530|NCT01139775|Other Pre-specified|Deaths|Deaths that occurred during the study are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Randomization through 12 months after the last participant was randomized|All enrolled participants.|||Participants|||Count of Participants
2714531|NCT01139775|Secondary|Phase 1: Document Any Antitumor Activity Per Radiological Scans and/or Tumor Markers|Overall response rate is presented. Overall response rate is defined as the percentage of participants with a best response of CR or PR as classified by the investigators according to RECIST, v1.1 criteria. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline through end of Phase 1|All randomized Phase 1 participants.|||percentage of participants||90% Confidence Interval|Number
2714532|NCT01139775|Secondary|Phase 2: Change From Baseline to Long-term Follow up in Lung Cancer Symptom Scale (LCSS)|"Health-related quality of life and participant symptoms were assessed using the LCSS (patient scale). However, improper implementation of questionnaires at the site level reduced the sponsor's ability to accurately evaluate the impacted data. Therefore, the LCSS data should be interpreted with caution.~The LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. The total LCSS score was calculated as the mean of 9 questions from the LCSS."|Randomization to the end of study (approximately 12 months after the last participant entered treatment)|All enrolled Phase 2 participants who had the baseline LCSS assessment and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2714533|NCT01139775|Secondary|Phase 2: Pharmacokinetic: AUC (LY2603618)|AUC (0-24), AUC(0-tlast), and AUC(0-∞) values are reported for LY2603618. The number of pharmacokinetic observations (n) used in the analysis is presented.|Cycle 1/Day 2 - predose, immediately prior to the end of the LY2603618 infusion, and 2-6, 24-48, and 72-96 hours postdose|Phase 2 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714534|NCT01139775|Secondary|Phase 2: Pharmacokinetic: Cmax (LY2603618)||Cycle 1/Day 2 - predose, immediately prior to the end of the LY2603618 infusion, and 2-6, 24-48, and 72-96 hours postdose|Phase 2 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714535|NCT01139775|Secondary|Phase 1: Pharmacokinetic: AUC (Pemetrexed and Cisplatin)|AUC(0-tlast) and AUC(0-∞) values are reported for pemetrexed and t-platinum from cisplatin. The number of pharmacokinetic observations (n) used in the analysis is presented for each drug.|Pemetrexed: Cycle 1/Day 1 - immediately prior to end of pemetrexed infusion and 1, 2, 6 and 24 hours postdose. Cisplatin: Cycle 1/Day 1 - immediately prior to end of cisplatin infusion and 0.5, 1, 2, 6, 24, 72, 96, and 168 hours postdose.|Phase 1 participants who received at least 1 dose of pemetrexed or cisplatin and had samples collected for pharmacokinetic analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714536|NCT01139775|Secondary|Phase 1: Pharmacokinetic: Area Under the Plasma Concentration Versus Time Curve (AUC) (LY2603618)|AUC from time zero to 24 hours (AUC[0-24]), AUC from time zero to the last time point with a measurable concentration (AUC[0-tlast]), and AUC from time zero to infinity (AUC[0-∞]) values are reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.|Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose|Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714537|NCT01139775|Secondary|Phase 1: Pharmacokinetic: Cmax (Pemetrexed and Cisplatin)|Cmax for pemetrexed and total platinum (t-platinum) from cisplatin is reported. The number of pharmacokinetic observations (n) used in the analysis is presented for each drug.|Pemetrexed: Cycle 1/Day 1 - immediately prior to end of pemetrexed infusion and 1, 2, 6 and 24 hours postdose. Cisplatin: Cycle 1/Day 1 - immediately prior to end of cisplatin infusion and 0.5, 1, 2, 6, 24, 72, 96, and 168 hours postdose.|Phase 1 participants who received at least 1 dose of pemetrexed or cisplatin and had samples collected for pharmacokinetic analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714538|NCT01139775|Secondary|Phase 1: Pharmacokinetic: Maximum Plasma Concentration (Cmax) (LY2603618)|Cmax is reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.|Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose|Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714539|NCT01139775|Secondary|Phase 2: Change in Tumor Size|Change in tumor size was based on tumor measurements collected according to RECIST, v1.1 guidelines. Tumor size is the sum of the tumor measurements (longest diameters) of target lesions at each tumor evaluation. Change in tumor size was defined as the change in log tumor size from baseline evaluation to the evaluation at the end of Cycle 2.|Baseline, end of Cycle 2|Participants with measureable disease (target lesions) at baseline who received at least 1 dose of study drug.|||centimeters||Standard Deviation|Mean
2714540|NCT01139775|Secondary|Phase 2: Overall Tumor Response Rate: Percentage of Participants Who Achieved a Confirmed Best Response of Completed Response (CR) or Partial Response (PR)|Overall response rate is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Randomization until date of disease progression (up to 6 months after the last participant was randomized)|All randomized Phase 2 participants.|||percentage of participants||90% Confidence Interval|Number
2714541|NCT01139775|Secondary|Phase 2: Overall Survival|Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.|Randomization to the date of death from any cause through the time of study discontinuation (approximately 12 months after last participant was randomized)|All randomized Phase 2 participants.|||months||90% Confidence Interval|Median
2714542|NCT01139775|Primary|Phase 1: Recommended Phase 2 Dose of LY2603618|The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after pemetrexed and cisplatin was based on the maximum tolerated dose (MTD) and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity [AUC(0-∞)] >21,000 nanogram*hour/milliliter [ng*h/mL] and maximum LY2603618 plasma concentration [Cmax] >2000 nanograms/milliliter [ng/mL]).|Time of first dose to last dose|Phase 1 participants who received at least 1 dose of any of the study drugs.|||mg|||Number
2714543|NCT01139775|Primary|Phase 2: Progression-Free Survival Time|Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.|Randomization up to first date of PD or death from any cause (up to 6 months after the last participant entered treatment)|All randomized Phase 2 participants.|||months||90% Confidence Interval|Median
2714544|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.|||units on a scale||Standard Error|Least Squares Mean
2714545|NCT01139762|Secondary|Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks|Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.|Baseline, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.|||milliliters (mL)||Standard Deviation|Mean
2714546|NCT01139762|Secondary|Clinician Global Impression of Improvement (CGI-I) at 26 Weeks|Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.|||participants|||Number
2714547|NCT01139762|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.|26 weeks|All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.|||units on a scale||Standard Deviation|Mean
2714549|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks|Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.|||units on a scale||Standard Error|Least Squares Mean
2714550|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.|||units on a scale||Standard Error|Least Squares Mean
2714551|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.|||units on a scale||Standard Error|Least Squares Mean
2714552|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.|||units on a scale||Standard Error|Least Squares Mean
2714553|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.|||units on a scale||Standard Error|Least Squares Mean
2714554|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks|"IPSS Quality of Life Index assesses participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction."|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.|||units on a scale||Standard Error|Least Squares Mean
2714555|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.|||units on a scale||Standard Error|Least Squares Mean
2714636|NCT01138826|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2714556|NCT01139762|Secondary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2714557|NCT01139762|Primary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 12 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2714558|NCT01139658|Secondary|Reasons for Usual Follow-up||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714559|NCT01139658|Secondary|Reasons for Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.||||||
2714560|NCT01139658|Secondary|Duration of Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.||||||
2714561|NCT01139658|Secondary|Frequency of Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||times per week||Standard Deviation|Mean
2714562|NCT01139658|Secondary|Reasons for Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714563|NCT01139658|Secondary|Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714564|NCT01139658|Secondary|Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714565|NCT01139658|Secondary|Number of Patients Who Switched to Another Anticoagulant Therapy|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|11 weeks||||participants|||Number
2714566|NCT01139658|Secondary|Concomitant Treatments|Concomitant treatments prescribed at hospital discharge.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714567|NCT01139658|Secondary|Adherence to Treatment|The adherence to treatment was measured by patient declaration.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||percent||Standard Deviation|Mean
2714568|NCT01139658|Secondary|Proportion of Patients With a Preoperative ALT Measurement||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||percentage of participants|||Number
2714569|NCT01139658|Secondary|Duration of Treatment||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||days||Standard Deviation|Mean
2714570|NCT01139658|Secondary|Duration Between Surgery and First Dose of Pradaxa||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||hours||Standard Deviation|Mean
2714571|NCT01139658|Secondary|Dosage of Pradaxa at Initiation||Baseline|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714572|NCT01139658|Primary|Occurrence of Major Bleeding Events|"Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.~a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE)."|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714573|NCT01139658|Primary|Occurrence of Symptomatic Venous Thromboembolic Events|Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
2714574|NCT01139580|Secondary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8|The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.|Week 8|ITT Population. Data were analyzed using the failure and LOCF methods.|||participants|||Number
2714575|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8|Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.|Baseline and Week 8|ITT Population|||participants|||Number
2714576|NCT01139580|Primary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).|||participants|||Number
2714577|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.|Baseline and Week 8|ITT Population|||participants|||Number
2714578|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8|Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.|Baseline and Week 8|ITT Population|||participants|||Number
2714579|NCT01139580|Primary|Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.|||participants|||Number
2714580|NCT01139515|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Hr||Standard Deviation|Mean
2714581|NCT01139515|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Hr||Full Range|Median
2714582|NCT01139515|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Full Range|Geometric Mean
2714583|NCT01139515|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Full Range|Geometric Mean
2714637|NCT01138826|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Full Range|Geometric Mean
2714584|NCT01139515|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng* hr/mL||Full Range|Geometric Mean
2714585|NCT01139450|Secondary|The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)||Baseline, 4 weeks|||||||
2714586|NCT01139450|Secondary|The Mean Change From Baseline in Pruritus||Baseline, 4 weeks|||||||
2714587|NCT01139450|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region||Baseline, 4 weeks|||||||
2714588|NCT01139450|Primary|Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment||4 weeks||||participants|||Number
2714589|NCT01139411|Secondary|Communication 2: Observed Parent-adolescent Communication Quality (DOCS)|Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.|||units on a scale||Standard Deviation|Mean
2714590|NCT01139411|Secondary|Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)|Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only|||units on a scale||Standard Deviation|Mean
2714591|NCT01139411|Secondary|Parent Modeling 4: Weight and Body Concerns (FERF-Q)|Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only|||units on a scale||Standard Deviation|Mean
2714592|NCT01139411|Secondary|Parent Modeling 3: Physical Activity (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only|||units on a scale||Standard Deviation|Mean
2714593|NCT01139411|Secondary|Parent Modeling 2: Self-monitoring (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.|||units on a scale||Standard Deviation|Mean
2714594|NCT01139411|Secondary|Parent Modeling 1: Dietary Choices (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.|||units on a scale||Standard Deviation|Mean
2714595|NCT01139411|Primary|Body Mass Index|Post-treatment BMI (controlling for baseline BMI)|Baseline and at completion of 16 week intervention||||kilograms/meters squared||Standard Deviation|Mean
2714596|NCT01139294|Secondary|Gorelick Assessment|"Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.~volume of fluid infuse over time~time to discharge from ED to home or transfer into the hospital~discharge diagnosis from ED~duration of any supplemental hospitalization for supplemental hydration~time to first urine output observed~requirement for rescue therapy and nature of the rescue therapy~incidence of readmission to hospital/ED~global assessment of overall satisfaction with rehydration therapy by parents and caregiver"|Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study.|No outcome measure data available. Study data was lost.Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.||||||
2714597|NCT01139294|Primary|Cardiac Output Trends|Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration|Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.|No outcome measure data available. Study data was lost. Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.||||||
2714598|NCT01139190|Primary|Degree of GI Injury at Day 15|"Degree of mucosal injury was assessed by endoscopy, with the following scoring system:~Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer"|15 days|Per Protocol Population: subset of participants who had an endoscopy performed at Day 15 reviewed by both blinded endoscopists, was at least 85% compliant with taking the study drug (based on pill counts), who took the final dose drug on the day of the second endoscopy, and who had no other protocol violations that would affect assessments.|||participants|||Number
2714599|NCT01139164|Secondary|Morbidity of Allogeneic Stem Cell Transplants|To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications.|100 days|This study terminated early; funding ran out before the analysis could be completed.||||||
2714600|NCT01139164|Secondary|To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants|To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome|Day +100|The outcome measure data below only accounts for the number of subjects who met the engraftment criteria prior at day +30; the chimerism data was not collected. For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.|||participants|||Number
2714601|NCT01139164|Primary|To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.|Number of subject deaths prior to day 100.|8 years|For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.|||participants|||Number
2714602|NCT01139125|Primary|Safety and Efficacy|We are measuring if this medication is appropriate for use in schizophrenia patients.|4 months|||||||
2714603|NCT01139047|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the subject preference survey at week 3|3 weeks|Safety|||participants|||Number
2714604|NCT01139047|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|day 22||||participants|||Number
2714605|NCT01139047|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety|||participants|||Number
2714606|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.|Up to 7 days after any vaccination|The analysis was done on safety subset.|||Number of Subjects|||Number
2714607|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|Up to 7 days after any vaccination.|The analysis was done on safety subset.|||Number of subjects|||Number
2714608|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.|The analysis was done on safety subset.|||Number of Subjects|||Number
2714609|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.||||Number of subjects|||Number
2714610|NCT01139021|Secondary|GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.~Analysis was done on MITT population (Secondary)."|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).|||Concentration IU/mL||95% Confidence Interval|Geometric Mean
2714611|NCT01139021|Secondary|Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|"To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains.~Analysis was done on MITT population (Secondary)."|1 month post two catch-up doses versus prevaccination|Analysis was done on MITT population (Secondary).|||Percentage of subjects||95% Confidence Interval|Number
2714612|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary)|||Percentage of subjects||95% Confidence Interval|Number
2714613|NCT01139021|Secondary|GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).|||Titers||95% Confidence Interval|Geometric Mean
2714614|NCT01139021|Secondary|GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).|||Concentration IU/mL||95% Confidence Interval|Geometric Mean
2714615|NCT01139021|Secondary|Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.|To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.|1 month post booster dose versus prebooster.|Analysis was done on MITT population (Secondary).|||Percentage of Subjects||95% Confidence Interval|Number
2714616|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|6month post booster dose and 12 months post two catch-up dose vaccination.|Analysis was done on MITT population (Secondary).|||Percentage of subjects||95% Confidence Interval|Number
2714617|NCT01139021|Secondary|GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).|||Titers||95% Confidence Interval|Geometric Mean
2714618|NCT01139021|Primary|Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953.~Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).|||Concentration IU/mL||95% Confidence Interval|Geometric Mean
2714619|NCT01139021|Primary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).~Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).|||Percentage of subjects||95% Confidence Interval|Number
2714620|NCT01139021|Primary|Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).~Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).|||Titers||95% Confidence Interval|Geometric Mean
2714621|NCT01139008|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the Subject Preference Survey at week 3|week 3|Safety|||participants|||Number
2714663|NCT01138475|Secondary|Serum Phosphorus|This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from all 3 participant arms|||mg/dL||Standard Deviation|Mean
2714622|NCT01139008|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|Day 22|Safety|||participants|||Number
2714623|NCT01139008|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety|||participants|||Number
2714624|NCT01138995|Secondary|User Satisfaction|Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,|Week 30|All randomized subjects were analyzed.|||units on a scale||Standard Deviation|Mean
2714625|NCT01138995|Secondary|Berg Balance Scale (BBS) Score|Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.|Week 30|All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.|||units on a scale||Standard Deviation|Mean
2714626|NCT01138995|Primary|Ten Meter Walk Test (10mWT)|"Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard usual ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm."|Week 30|Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.|||meters per second (m/s)||Standard Deviation|Mean
2714627|NCT01138969|Secondary|Peptic Ulcer Bleeding|participants with peptic ulcer bleeding within 6 months|6 months|Intention to treat|||participants|||Number
2714628|NCT01138969|Primary|Recurrent Peptic Ulcer|Number of participants with recurrent peptic ulcer within 6 months|6 months|Intention to treat|||participants|||Number
2714629|NCT01138917|Secondary|Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)|"Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16.~Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires.~Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional."|Pain (Weeks 1-16) and Appearance (Weeks 16-52)|Per-Protocol Population|||Scores on a Scale (0-100)||Standard Deviation|Mean
2714630|NCT01138917|Secondary|Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)|"Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16.~Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires.~Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional"|Pain (Weeks 1-16) and Appearance (Weeks 16-52)|Per-Protocol Population|||Scores on a Scale (0-100)||Standard Deviation|Mean
2714631|NCT01138917|Secondary|Wound Closure at Week 2 (Based on Investigators Assessment)|The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.|Week 2||||Participants|||Count of Participants
2714632|NCT01138917|Secondary|Percent of Epithelialization at Each Visit Through Week 16|The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.|Each visit through Week 16|Percent Epithelialization presented for Per Protocol Population (PP) based on subjects presented for healing evaluation per visit|||percentage of epithelialization||Standard Deviation|Mean
2714633|NCT01138917|Primary|Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)|Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.|1 week|Analysis was performed on ITT, PP, and MPP populations. Note: The number of participants with evaluable donor sites differs than number of participants with evaluable recipient sites.|||Participants|||Count of Participants
2714634|NCT01138917|Primary|Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)|Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was >=95% epithelialized.|4 weeks|Analysis to evaluate non-inferiority of recipient site wound closure was performed on the ITT, PP, and MPP populations.|||Participants|||Count of Participants
2714664|NCT01138475|Secondary|Serum 25 OH Vitamin D|This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from participant in paricalcitrol arm|||ng/dL||Standard Deviation|Mean
2714638|NCT01138826|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
2714639|NCT01138826|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
2714640|NCT01138735|Secondary|Change in Inflammatory Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF|||lesion count change||Standard Deviation|Mean
2714641|NCT01138735|Secondary|Percent Change in Total Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF|||percentage of change in lesion count||Standard Deviation|Mean
2714642|NCT01138735|Primary|Change From Baseline in Total Lesion Counts||Baseline to Week 12 (LOCF)|ITT population, LOCF|||lesion count change||Standard Deviation|Mean
2714643|NCT01138735|Primary|Success Rate|Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent to treat (ITT) population, LOCF|||percentage of participant|||Number
2714644|NCT01138657|Secondary|Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
2714645|NCT01138657|Secondary|Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
2714646|NCT01138657|Secondary|Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
2714647|NCT01138657|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
2714648|NCT01138657|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Central retinal thickness was measured using optical coherence tomography and assessed by a central reader.|Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||percent change||Standard Deviation|Mean
2714649|NCT01138657|Secondary|Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline|||months||Inter-Quartile Range|Median
2714650|NCT01138657|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart.|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||logMAR||Standard Deviation|Mean
2714651|NCT01138657|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured."|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
2714652|NCT01138657|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell;~Grade 0.5+ = 1-5 cells;~Grade 1+ = 6-15 cells;~Grade 2+ = 16-25 cells;~Grade 3+ = 26-50 cells;~Grade 4+ = > 50 cells."|From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points (best state achieved prior to Week 6 and at least 1 post-week 6 value); last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
2714653|NCT01138657|Primary|Time to Treatment Failure on or After Week 6|"Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:~New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline~Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 6 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.|||months||Inter-Quartile Range|Median
2714654|NCT01138514|Secondary|Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)|Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.|10 weeks|per-protocol population|||participants|||Number
2714655|NCT01138514|Primary|Percent Change From Baseline in Non-inflammatory Lesions||10 weeks|Per protocol population|||percentage of lesion reduction||Standard Deviation|Mean
2714656|NCT01138514|Primary|Percent Change From Baseline in Inflammatory Lesions||10 weeks|Per protocol population|||percentage of lesion reduction||Standard Deviation|Mean
2714657|NCT01138501|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||events|||Number
2714658|NCT01138501|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.|The safety analysis set includes all 63 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 59 subjects had 50 exposure days (EDs).|||N with Inhibitors / N with ≥50 EDs|||Number
2714659|NCT01138475|Secondary|24 Hour Urine Calcium|This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|Missing data from paricalcitol and cholecalciferol arms|||mg/dL||Standard Deviation|Mean
2714660|NCT01138475|Secondary|Bone Specific Alkaline Phosphatase|This secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks||||u/L||Standard Deviation|Mean
2714661|NCT01138475|Secondary|N-Telopeptide Cross Linked Urine|This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|Missing data from cholecalciferol and placebo participant arms|||nmol||Standard Deviation|Mean
2714662|NCT01138475|Secondary|Osteocalcin|This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|Missing data from all 3 participant arms|||ng/mL||Standard Deviation|Mean
2714666|NCT01138475|Secondary|Alkaline Phosphatase|This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study|6 weeks|missing 1 participant data in the paricalcitol group|||U/L||Standard Deviation|Mean
2714667|NCT01138475|Primary|The Primary Outcome Measure With iPTH|Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study|6 weeks|missing data in paricalcitol and placebo group|||pg/mL||Standard Deviation|Mean
2714668|NCT01138150|Secondary|Resistin|serum resistin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
2714669|NCT01138150|Secondary|Leptin|serum leptin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
2714670|NCT01138150|Secondary|Low Molecular Weight (LMW):Total (T)-ADP|serum LMW:T-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ratio||95% Confidence Interval|Mean
2714671|NCT01138150|Secondary|High Molecular Weight (HMW): T-ADP|serum HMW:T-ADP levels after treatment in responders and non responders|30 minutes, 60 minutes, 120 minutes after treatment||||ratio||95% Confidence Interval|Mean
2714672|NCT01138150|Secondary|Low Molecular Weight (LMW)-ADP|serum LMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
2714673|NCT01138150|Secondary|Middle Molecular Weight (MMW)-ADP|serum MMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
2714674|NCT01138150|Secondary|High Molecular Weight (HMW)-Adiponectin (ADP)|serum HMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
2714675|NCT01138150|Primary|Change in the Total Serum Adiponectin (T-ADP)|Change in total serum adiponectin after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
2714676|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714677|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714678|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714679|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714680|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714681|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714682|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714683|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
2714684|NCT01138111|Secondary|Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress|"Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive.~For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point.~Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point.~PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period.~NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period."|2 scanning periods post injection to be evaluated at baseline|All subjects with PET data at the referenced study time point|||percentage of subjects|||Number
2714685|NCT01138111|Secondary|Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress|At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader's evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.|2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months|All subjects with PET data at the referenced study time point|||participants|||Number
2714686|NCT01138111|Secondary|Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4|This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.|1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months|All subjects receiving study drug|||participants|||Number
2714687|NCT01138111|Primary|Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake|Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)|1 scanning period post injection to be evaluated at baseline, 12 months and 24 months|All subjects receiving study drug with PET scan data at the respective timepoint|||SUVR||Standard Deviation|Mean
2714688|NCT01138098|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|After the challenge dose of Engerix-B vaccine up to the study end|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
2714689|NCT01138098|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
2714690|NCT01138098|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)).|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
2714691|NCT01138098|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
2714692|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before the challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
2714693|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before and one month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
2714694|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL|A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
2714695|NCT01138098|Secondary|Number of Subjects With an Anamnestic Response to a Challenge Dose|The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
2714903|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714696|NCT01138098|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
2714697|NCT01138046|Secondary|Drug Clearance (CL) of Paclitaxel|CL is defined as the volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. CL was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation.|||mL/hour/m^2||95% Confidence Interval|Geometric Mean
2714698|NCT01138046|Secondary|Half-life (t1/2) of Paclitaxel|Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half. T1/2 was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||Hr||95% Confidence Interval|Geometric Mean
2714699|NCT01138046|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel|Vss is the volume of distribution at steady state of paclitaxel. Vss was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||milliliter per meters squared (mL/m^2)||95% Confidence Interval|Geometric Mean
2714700|NCT01138046|Secondary|Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel|Tmax is defined as the time to peak concentration from initiation of lapatinib and paclitaxel dosing. Tmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||Hr||Full Range|Median
2714701|NCT01138046|Secondary|AUC From Time Zero to Infinity (0-INF) of Paclitaxel|AUC(0-INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC (0-INF) was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2714702|NCT01138046|Secondary|Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel|AUC is defined as the area under the lapatinib or paclitaxel concentration-time curve from time 0 to 24 hours (hrs). AUC (0-24) was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||hours * nanograms/milliliter (hr*ng/mL)||95% Confidence Interval|Geometric Mean
2714703|NCT01138046|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel|Cmax is defined as the maximum concentration of lapatinib and paclitaxel. Cmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|Pharmacokinetic (PK) Population: all participants who provided blood samples for PK evaluation|||Nanogram per milliliter ng/mL||95% Confidence Interval|Geometric Mean
2714704|NCT01138046|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined using RECIST as the number of participants who received at least one dose of study medication and achieved a best OR classified as CR, PR or SD for at least 6 months (24 weeks), i.e., CR + PR + SD for >=24 weeks. CBR was based on confirmed responses by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. SD is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the the four preceding definitions was considered Not evaluable|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.|||Participants|||Number
2714705|NCT01138046|Secondary|Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)|Best OR was defined as the best response recorded from the start of treatment until progressive disease (PD)/death as assessed by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the four preceding definitions was considered Not evaluable.|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.|||Participants|||Number
2714706|NCT01138046|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of a CR or a PR until the first documented sign of disease progression or death due to any cause (whichever occured earlier). The analysis was based on responses as evaluated by the investigator and was confirmed at a repeat assessment, with the duration of response taken from the first time the response was observed. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 953 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed. For participants who did not progress or die, duration of response was censored on the date of the last assessment.|||Months||95% Confidence Interval|Median
2714707|NCT01138046|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until first documented evidence of partial response (PR) or a complete response (CR) (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the start of treatment until the first documented evidence of a PR or CR, whichever status is recorded first (up to 66 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed.|||Months||95% Confidence Interval|Median
2714708|NCT01138046|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the start of treatment and the earliest date of radiological disease progression or death due to any cause, whichever occurred first. PFS was based on the investigator's assessment. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until the earliest date of radiological disease progression or death due to any cause, whichever occured first (up to 1009 Days).|All Subjects Population. Participants who met the following criteria were censored: no Baseline assessment, no progression, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment started, and death or progression after more than one missed visit.|||Months||95% Confidence Interval|Median
2714709|NCT01138046|Primary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until death due to any cause or study close, whichever occurred first (assessed up to a maximum of 1290 Days)|All Subjects Population: all participants who received at least one dose of study medication|||Months||95% Confidence Interval|Median
2714710|NCT01138046|Primary|Number of Participants With Intolerable Toxicities in Phase I of the Study|Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.|28 days|All Subjects Population: all participants who received at least one dose of study medication and participated in Phase I of the study.|||Participants|||Number
2714711|NCT01138007|Secondary|Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). Only five items (item 19: general interest; item 20: energy level; item 21: capacity for pleasure or enjoyment, excluding sex; item 22: interest in sex; item 30: leaden paralysis/physical energy) were evaluated for this endpoint, as a subset of the total score. The lowest possible total score and subset total score of IDS-SR are 0 and 0, and the highest possible total score and subset total score of IDS-SR are 84 and 15, respectively. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR subscore and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2714712|NCT01138007|Secondary|Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). The maximum total score is 84 (0: no symptoms; 84: greatest symptom severity), as participants were asked to answer either item 11 (decreased appetite) or item 12 (increased appetite) (not both) and either item 13 (decreased weight) or item 14 (increased weight) (not both). Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2714713|NCT01138007|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8|A CGI-SI assessment was performed in terms of severity in depression, by using scores from 0 to 7: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill participants. Change from Baseline in the CGI-SI score was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline CGI-SI score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2714714|NCT01138007|Secondary|Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8|A CGI-GI assessment was performed at Week 8 (or withdrawal) in comparison with severity in depression observed at Baseline (Week 0; no actual assessment was performed at Baseline [the comparison was subjective]), by using scores from 0 to 7: 0, Not assessed; 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse. A CGI-GI responder is defined as a participant with a CGI-GI score of very much improved or much improved at Week 8.|Week 8|FAS. Missing values were imputed using LOCF. Only those participants who were available at Week 8 were analyzed.|||participants|||Number
2714715|NCT01138007|Secondary|Number of MADRS Remitters at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score <=11 at Week 8.|Week 8|FAS. Missing values were imputed using LOCF.|||participants|||Number
2714716|NCT01138007|Secondary|Number of MADRS Responders at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a >=50% reduction from Baseline in the MADRS total score at Week 8.|Baseline and Week 8|FAS. Missing values were imputed using LOCF.|||participants|||Number
2714717|NCT01138007|Secondary|Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8|The MADRS scale measures the depression level of a participant using the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). Scores for MADRS items 1, 2, 6, 7, and 8 were evaluated for this endpoint. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score of each item and region as covariates.|Baseline; Week 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2714718|NCT01138007|Secondary|Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|Baseline; Weeks 1, 2, 4, and 6|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2714719|NCT01138007|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.|Baseline and Week 8/Withdrawal|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e. Week 1 or later). Missing values were imputed using Last Observation Carried Forward (LOCF): last observed non-missing value was used to fill missing values at a later point.|||Scores on a scale||Standard Error|Least Squares Mean
2714720|NCT01137890|Secondary|Drug Value Questionnaire|"Street Value of Sampled Dose. After co-administration of cocaine-zonisamide, participants were asked to hypothetically estimate the value of the drug they received, if they were to purchase it on the street. The mean value (dollars) across all drug conditions is reported here.~Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (0, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis. Additionally, all 8 subjects who received zonisamide completed both 300mg and 600mg doses.~Within-subject repeated interval during self-administration sessions. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times"|Weeks 1-5; mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administration cocaine-zon affects this measure, only zon participants are included (n=8). Each participant receives varying doses of zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5|||dollars||Standard Deviation|Mean
2714721|NCT01137890|Primary|Cocaine Craving|Cocaine craving measured by Cocaine Selectivity Severity Assessment (CSSA). The CSSA is a reliable and valid tool to measure cocaine withdrawal severity within a 24 hr period, and has been shown to predict treatment response in a treatment setting. Participants are asked to rate 18-items on a Likert scale 0-7, with composite scores ranging 0-126 and higher numbers indicative of more severe withdrawal. Mean scores on CSSA across 39-day time period are reported.|Day 1-39|Includes all participants analyzed (n=12; 8 zonisamide, 4 placebo)|||units on a scale||Standard Deviation|Mean
2714722|NCT01137890|Primary|Behavioral Choice Measures|"In each condition of cocaine-zonisamide dose, participants were asked to choose whether they would rather have a repeated cocaine dose (same dose as most recent administration) or cash of varying monetary value. The mean number of cocaine choices across each drug condition are reported. This measure only included participants in the zonisamide (Zon) condition (n=8), with each arm representing variation in co-administration of cocaine-Zon.~Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (1, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis.~During self-administration sessions are every 15 min over 1hr45min period. Assessment on Weeks 1 (0mg Zon), 3 (300mg Zon), 5 (600mg Zon), in which varying cocaine doses co-administered. Cocaine not administered (only Zon) during Weeks 2 & 4"|Weeks 1-5, mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administered of cocaine-Zon affects this measure, only Zon participants are included (n=8). Each participant receives varying doses of Zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each Zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5|||number of cocaine choices||Standard Deviation|Mean
2714723|NCT01137890|Primary|Change in Visual Analog Questionnaire (VAQ) Score|"VAQ measures the change in effect after dose administration. Participants rate 6 items (Any Drug Effect, Rush, Good Effects, Bad Effects, Liking, & Desire for Cocaine) by pointing an arrow along a 100-point line anchored at either end with none (0) & extremely (100). Each participant's score is equal to the sum of all 6 ratings, & the mean of all participant's scores is reported across each condition. The VAQ is only administered to subjects in the zonisamide (Zon) condition (n=8). Repeated within-subject measures ANOVA performed to observe the main effects of Zon dose (0, 300, & 600mg) & cocaine dose (1, 20, & 40mg), & their interaction. All 8 subjects who received Zon completed both 300mg & 600mg doses. Assessments obtained on Week 1 (0mg Zon), Week 3 (300mg Zon), & Week 5 (600mg Zon), in which all 3 cocaine were co-administered at these times. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times"|Weeks 1-5; mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administered of cocaine-Zon affects this measure, only Zon participants are included (n=8). Each participant receives varying doses of Zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each Zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5|||units on a scale||Standard Deviation|Mean
2714724|NCT01137812|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2714725|NCT01137812|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2714726|NCT01137812|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
2714727|NCT01137812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2714728|NCT01137812|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2714729|NCT01137812|Secondary|Percentage of Patients With HbA1c <7% at Week 52|The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.|Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2714935|NCT01136486|Primary|Assessment of Pain Severity|Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service.|Referral||||units on a scale||Standard Deviation|Mean
2714730|NCT01137812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2714731|NCT01137786|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.|Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2714732|NCT01137773|Secondary|Blood Glucose Concentration|average blood glucose concentration while the patients received insulin drip|24 h||||mg/dl blood||Standard Deviation|Mean
2714733|NCT01137773|Primary|Karnovsky Performance Status Scale of Functional Impairment|"The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions:~Normal no complaints; no evidence of disease - 100 Able to carry on normal activity; minor signs or symptoms of disease- 90 Normal activity with effort; some signs or symptoms of disease - 80 Cares for self; unable to carry on normal activity or to do active work - 70 Requires occasional assistance, but is able to care for most of his personal needs - 60 Requires considerable assistance and frequent medical care - 50 Disabled; requires special care and assistance - 40 Severely disabled; hospital admission is indicated although death not imminent - 30 Very sick; hospital admission necessary; active s"|3 months||||units on a scale||Standard Deviation|Mean
2714734|NCT01137682|Secondary|Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)|"PK samples were collected for those patients treated with pasireotide LAR in the core study and who continued on pasireotide LAR in the extension phase. PK samples were collected before the injection of pasireotide LAR only at weeks 112 and 196. PK samples were also collected at weeks 48 and 132 only for all patients treated with octreotide LAR 30 mg or lanreotide ATG 120 mg in the core study who started treatment with pasireotide LAR in the extension study.~Blood samples (2.5 mL each sample) were collected to yield 1-mL plasma for analysis of pasireotide LAR oncentration."|Extension baseline up to approximately 196 weeks|Available data for analysis varies at visits|||mL||Standard Deviation|Mean
2714735|NCT01137682|Secondary|Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)|Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.|CORE Baseline and extension baseline up to approximately 268 weeks|completed and valid questionnaires at visits|||scores on a scale||Standard Deviation|Mean
2714736|NCT01137682|Secondary|Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set)|Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.|CORE baseline up to approximately 24 weeks|Available data available for analysis differed from visit to visit|||scores on a scale||Standard Deviation|Mean
2714737|NCT01137682|Secondary|Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly|Time to first response is defined as the time from the date of first dose to the date of first occurrence of a reduction of mean GH < 2.5 µg/L and the normalization of IGF-1. The weeks correspond to time taken to achieve first mean GH < 2.5 µg/L and the normalization of IGF-1.|CORE baseline up to approximately 268 weeks||||weeks||95% Confidence Interval|Median
2714738|NCT01137682|Secondary|Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|n is the number of patients achieving response criteria. The weeks correspond to duration of first response (in weeks) for patients achieving biomedical control. Median and 95% CI are derived from Kaplan-Meier curves. Kaplan-Meier estimates [95% CI] at each time point are estimates of probability of response.|CORE baseline up to approximately 268 weeks||||weeks||95% Confidence Interval|Median
2715357|NCT01133665|Secondary|Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2714739|NCT01137682|Secondary|Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)|Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range|CORE and extension baseline up to approximately 268 weeks|Available data for analysis differed from visit to visit|||mcg/L||Standard Deviation|Mean
2714740|NCT01137682|Secondary|Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)|Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range|CORE baseline up to approximately 24 weeks|Available data for analysis varies from visit to visit|||mcg/L||Standard Deviation|Mean
2714741|NCT01137682|Secondary|Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)|Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm.|CORE and extension baseline up to approximately 268 weeks|Available data for analysis differed from visit to visit|||mcg/L||Standard Deviation|Mean
2714742|NCT01137682|Secondary|Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)||CORE baseline up to approximately 24 weeks|Number analyzed is based on available data at specific visits|||mcg/L||Standard Deviation|Mean
2714743|NCT01137682|Secondary|Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)|Extension baseline up to approximately week 268||||percentage of participants||95% Confidence Interval|Number
2714744|NCT01137682|Secondary|Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set|Extension baseline up to approximately week 268||||Participants||95% Confidence Interval|Number
2714745|NCT01137682|Secondary|Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 2.5 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)|Extension baseline up to approximately week 268|Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.|||percentage of participants||95% Confidence Interval|Number
2714746|NCT01137682|Secondary|Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set).|The percentage of patients achieving normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)|Extension baseline up to approximately week 268||||percentage of participants||95% Confidence Interval|Number
2714747|NCT01137682|Secondary|Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 2.5 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (extension full analysis set)|Extension baseline up to approximately week 268||||percentage of participants||95% Confidence Interval|Number
2714854|NCT01137006|Secondary|IMC-20D7S PK: Half-life (t½)|A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.|Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.|No participant was analyzed.||||||
2714748|NCT01137682|Primary|Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.|The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels <2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to < 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.|At 24 weeks||||percentage of participants||95% Confidence Interval|Number
2714749|NCT01137604|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.|At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3)|Full Analysis Set included all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2714750|NCT01137604|Secondary|Pharmacokinetic (PK) Profile and Pharmacodynamics (PD) of Lenvatinib|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Blood samples collected at Cycle 1 on Days 1 and 15 and in Cycle 2 on Day 1|||||||
2714751|NCT01137604|Secondary|Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Participants|||Number
2714752|NCT01137604|Secondary|Clinical Benefit Rate (CBR)|CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2714753|NCT01137604|Secondary|Disease Control Rate (DCR)|DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2714754|NCT01137604|Secondary|Overall Survival (OS)|OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Months||95% Confidence Interval|Median
2714755|NCT01137604|Secondary|Progression Free Survival|PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Months||95% Confidence Interval|Median
2714756|NCT01137604|Secondary|Objective Response Rate (ORR)|ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years)|Full Analysis Set included all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2714772|NCT01137474|Primary|Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12|HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||Percent||Standard Error|Mean
2714757|NCT01137578|Primary|All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT|Adjudication was by an Independent Central Adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. One set of 3 study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|n=participants with an adjudicated DVT identified by a study-related adjudicated radiographic procedure.|||participants|||Number
2714758|NCT01137578|Primary|Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group|MRI with contrast (c) and without (w/o) contrast (c) enhancement were performed and a US was done within 48 hours of the MRI. Once detected, the DVT was adjudicated and confirmed by an independent central adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. Participants were considered positive for DVT if at least one of the radiographic procedures was positive. Cohort A: Day 0=day of catheter placement; Day 40 (± 20 days)=day of imaging procedures at Visit 1, or if possible within 72 hours after a CVC is removed or lost. Cohort B Visit 1: within 7 days of initiation of symptoms of a CVC-related DVT (symptoms include but were not limited to: redness, pain/tenderness, swelling, presence of subcutaneous collaterals, catheter occlusion, and the presence of catheter related infection) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure. n=number of adjudicated images|||participants|||Number
2714759|NCT01137578|Secondary|Number of Deaths Which Occurred During the Study|Death as an endpoint in a participant with an adjudicated venous thromboembolism (DVT or PE) was summarized, regardless of the cause of the death. The VTE was adjudicated by a blinded central independent adjudication committee.|Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.|||participants|||Number
2714760|NCT01137578|Primary|Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast|Bilateral US was attempted but if it could not be completed, a unilateral US was accepted for analysis. Participants who did not complete the MRI procedure with contrast could be different participants from those who did not complete the MRI procedure without contrast. Primary reasons for non-completion of imaging included: technical, investigator decision, child refused, parent refused, child missed appointment, difficulties with anesthesia/sedation, child unable to lie still, problems with contrast administration, and other reasons. Other reasons could include: late to appointment and unable to perform MRI due to time constraints; logistical reasons, parent agreed to only ultrasound at time of consent, schedule delay, equipment not available, difficulty putting patient in correct position. Due to the small numbers of participants in some cohorts, these data were more meaningful with all cohorts grouped together for the total imaged population.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|Participants had at least 1 radiographic procedure performed but were unable to complete a either an Ultrasound (neither bilateral or unilateral, or could complete only a unilateral US) and/or unable to complete an MRI with contrast and/or unable to complete an MRI without contrast.|||participants|||Number
2714761|NCT01137578|Primary|Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age|One set of diagnostic imaging procedures (US and MRI) was to be performed for all cohorts The MRI consisted of MRI venous imaging without contrast enhancement and MRI venous imaging with contrast enhancement.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.|||participants|||Number
2714762|NCT01137578|Secondary|Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study|Signs and symptoms of PE include shortness of breath, pleuritic pain, cough, orthopnea, wheezing, and may have associated signs and symptoms of DVT. In the event a PE was detected while undergoing the study MRI or other imaging procedure required for care of an underlying condition, and the participant did not manifest any signs and/or symptoms of a PE, the event was considered an asymptomatic PE. The participant was managed and further investigated according to the investigator's standard of care. All diagnostic imaging procedures performed, such as contrast-enhanced computer tomography (CT) pulmonary angiogram, nuclear ventilation perfusion lung scan (V/Q scan), were submitted for adjudication as a suspected PE.|Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.|||participants|||Number
2714763|NCT01137578|Secondary|Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment|Adjudication was by an ICAC consisting of experienced physicians not involved in the study and blinded to each participant's identity and clinical course. One set of Study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|All participants who had an adjudicated DVT identified by at lest one study-related radiographic procedure.|||Participants|||Number
2714848|NCT01137006|Secondary|Recommend Doses for Phase 2/3 Studies Based on MTD|It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.|Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]|No participant was analyzed.||||||
2714764|NCT01137578|Primary|Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group|Imaging was performed on Visit 1 which was defined for Cohort A as: Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 defined for Cohort B: within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI. All 3 imaging procedures, ultrasound, MRI with contrast, MRI without contrast were to be performed on all participants, regardless of the cohort.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.|||participants|||Number
2714765|NCT01137578|Primary|Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast|One set of 3 diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Imaging was performed on Visit 1, which in Cohort A was Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 in Cohort B was within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI, which was scheduled for a clinical reason. Note: participants completing each MRI procedure (with contrast or without contrast) could be different participants.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.|||participants|||Number
2714766|NCT01137539|Secondary|Patient Satisfaction|Positive response to a satisfaction question|12 months|49 subjects were analyzed at the 12 month period out of the total 50 subjects enrolled in the study.|||Participants|||Count of Participants
2714767|NCT01137539|Primary|Treatment Success Based on Patient Report on Validated Questionnaire|"Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, Do you currently experience urine leakage related to physical activity, coughing or sneezing. If a subject answers No, this is considered success. If a subject answers Yes, this is considered failure of treatment."|24 months|46 subjects were analyzed at the 24 month period out of the total 50 subjects enrolled in the study.|||Participants|||Count of Participants
2714768|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12|Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mg/dL||Standard Error|Mean
2714769|NCT01137474|Secondary|Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
2714770|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12|All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
2714771|NCT01137474|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
2714849|NCT01137006|Secondary|Progression-Free Survival (PFS)|PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.|First dose to disease progression or death (up to 27 weeks)|Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3.|||participants|||Number
2714773|NCT01137474|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12|Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
2714774|NCT01137435|Other Pre-specified|Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™|"Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.~All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period."|7 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Number of Events|||Number
2714775|NCT01137435|Other Pre-specified|Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Participants|||Number
2714776|NCT01137435|Other Pre-specified|Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™|Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Participants|||Number
2714777|NCT01137435|Primary|Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Participants|||Number
2714778|NCT01137396|Secondary|Change in N3 (Slow-wave) Sleep Time||change from week 1 to week 2 of inpatient treatment||||minutes||Standard Error|Mean
2714779|NCT01137396|Primary|%Cocaine Free Urines||3x/week||||percent||Standard Error|Mean
2714780|NCT01137370|Primary|Median 25-OHD Level||August 2010 to March 2011||2011-10-31|10/2011||||
2714781|NCT01137370|Primary|Prevalence of Vitamin D Deficiency||At enrollment||||participants, %|||Number
2714782|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the tolerability of voriconazole at the EOT Visit.|||participants|||Number
2714783|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the efficacy of voriconazole at the EOT Visit.|||participants|||Number
2714784|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|more than 2 weeks (Test-of-Cure visit)|FAS.|||participants|||Number
2714785|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|up to 2 weeks (EOT visit)|Full Analysis Set (FAS) = all enrolled participants who were administered the study medication and had post baseline documentation of efficacy available.|||participants|||Number
2714786|NCT01137110|Primary|In-hospital Seizures|from admission to In-hospital seizures after aSAH|from hospital admission to hospital discharge||||Participants|||Count of Participants
2714787|NCT01137071|Secondary|Two-year Overall Survival: Median Time to Death|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.|Within the ITT population, 7 patients died and 22 were censored. The median time to death was 25.1 months (95% CI, 16.7 to 32.4 months).|||months||95% Confidence Interval|Median
2714788|NCT01137071|Secondary|Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)|Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.|Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9|PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks|||(µg/mL)||Standard Deviation|Mean
2714789|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714790|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714791|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714792|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714793|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714794|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714795|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714796|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714850|NCT01137006|Secondary|Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)|Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.|Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)|No participant was analyzed.||||||
2714797|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714798|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714799|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714800|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714801|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)|The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714802|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714803|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714804|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714805|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714851|NCT01137006|Secondary|IMC-20D7S PK: Volume of Distribution (Vd) at Steady State|A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.|Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.|No participant was analyzed.||||||
2714806|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714807|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714808|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714809|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714810|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714811|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714812|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714813|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714814|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714852|NCT01137006|Secondary|IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)|A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.|Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.|No participant was analyzed.||||||
2714815|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714816|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714817|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714818|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714819|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714820|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714821|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714822|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714823|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714853|NCT01137006|Secondary|IMC-20D7S PK: Clearance (Cl)|A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.|Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.|No participant was analyzed.||||||
2714824|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714825|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714826|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714827|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714828|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714829|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714830|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714831|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714832|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714833|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714834|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714835|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714836|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714837|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
2714838|NCT01137071|Secondary|Safety - Vital Signs - Temperature|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14|||°C||Standard Deviation|Median
2714839|NCT01137071|Secondary|Safety - Vital Signs - Systolic and Diastolic Blood Pressure|Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14|||mmHg||Standard Deviation|Median
2714840|NCT01137071|Secondary|Safety - Vital Signs - Respiratory Rate|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14|||ipm (Incursions per minute)||Standard Deviation|Median
2714841|NCT01137071|Secondary|Safety - Vital Signs - Heart Rate|Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.|Baseline, week 2 , week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14|||bpm||Standard Deviation|Median
2714842|NCT01137071|Secondary|Two-year Overall Survival Rate|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.|Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.|||percentage of participants|||Number
2714843|NCT01137071|Secondary|1-year Disease Progression-free Survival Rate||1 year from the beginning of platinum-based rescue chemotherapy start date|In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.|||percentage of participants|||Number
2714844|NCT01137071|Primary|1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy|"PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.~Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented."|1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.|In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).|||Months||95% Confidence Interval|Median
2714845|NCT01137032|Secondary|and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.||22 days|15 subjects represents the subgroup utilized for the analysis of this endpoint.|||participants|||Number
2714846|NCT01137032|Secondary|Pre-injection Serum Cortisol Levels|The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.|||participants|||Number
2714847|NCT01137032|Primary|Post-injection Serum Cortisol Level|The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.|||participants|||Number
2714855|NCT01137006|Secondary|IMC-20D7S PK: Minimal Concentration (Cmin)|A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.|Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.|No participant was analyzed.||||||
2714856|NCT01137006|Secondary|IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)|A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.|Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.|No participant was analyzed.||||||
2714857|NCT01137006|Primary|Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death|A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline through 30 days post last dose (up to 31 weeks)|Participants who received any amount of IMC-20D7S .|||participants|||Number
2714858|NCT01137006|Primary|Maximum Tolerated Dose (MTD) of IMC-20D7S|The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.|Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]|Participants who completed Cycle 1 of treatment.|||mg/kg q2w|||Number
2714859|NCT01136967|Secondary|Summary of Plasma Concentration of Lenvatinib|Blood samples for the quantification of lenvatinib in plasma were obtained and processed using a standardized protocol. The lower limit of quantification was 0.25 ng/mL. Pharmacokinetic (PK) analysis was conducted using nonlinear mixed effects modeling. Descriptive statistics were used to summarize lenvatinib plasma concentration data.|Predose and 2 to 12 hours postdose at Cycle 1 Day 1 (C1D1), Cycle 1 Day 15 (C1D15), and Cycle 2 Day 1 (C2D1)|The PK analysis set was used for analysis and included all participants who received at least one dose of lenvatinib and had at least one quantifiable lenvatinib concentration. Number analyzed (n) signifies participants who were evaluable at specific time points for this outcome measure.|||ng/mL||Standard Deviation|Mean
2714860|NCT01136967|Secondary|Change From Baseline in the Concentration of Clinical Biomarkers in Whole Blood|Blood samples were drawn at specific time points. Utilizing a standard protocol, the deoxyribonucleic acid (DNA) from whole blood was extracted and analyzed for specific biomarkers of absorption, distribution, metabolism, and excretion of lenvatinib. Some of the biomarkers analyzed included; Angiopoietin, Epidermal Growth Factor (EGF), Fibroblast Growth Factor (FGF), FMS Like Tyrosine Kinase 3 Ligand (Flt3l) Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte Macro Colony Stimulating Factor (GM-CSF), Interleukin 1 Receptor Antagonist (IL-1RA), Interferon (IFN), Macrophage Inflammatory Protein (MIP) 1 alpha, Platelet Derived Growth Factor (PDGF), Stromal Cell Derived Factor (SDF) 1 alpha, Interleukin (IL), Transforming Growth Factor (TGF), Tumor Necrosis Factor (TNF), Vascular Endothelial Growth Factor (VEGF).|Cycle 1 Day 15 (C1 D15), Cycle 2 Day 1 (C2 D1), Cycle 3 Day 1 (C3 D1), Off-Treatment/Phase Visit 98 (V98)|The Safety Analysis set was used and included all participants who received at least one dose of lenvatinib and had at least 1 postbaseline safety evaluation. Number analyzed (n) signifies participants who were evaluable at specific time points for this outcome measure.|||pg/mL||Standard Deviation|Mean
2714861|NCT01136967|Secondary|Number of Participants With Adverse Events (AEs)/ Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECGs), and multi-gated acquisition (MUGA) scans or echocardiogram.|From date of treatment start up to 30 days after the last dose, or up to data cutoff (Cohort 1; 15 Jan 2012 and Cohort 2; 15 Apr 2013), up to approximately 2 years 9 months|Safety Analysis Set included those participants who received at least 1 dose of study drug and had at least 1 post baseline safety evaluation.|||Participants|||Number
2714862|NCT01136967|Secondary|Clinical Benefit Rate (CBR)|CBR, (CBR = CR + PR + durable SD rate) was defined as the percentage of participants who had a BOR of CR or PR or durable SD (dSD, SD lasting >=23 weeks) based on RECIST v1.1 for target lesions assessed by MRI/CT, IRR and Investigator's assessment. A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a subsequent assessment of CR or PR at least 4 weeks later. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; OR = CR + PR. A BOR of dSD, the time from the first administration of study drug until the date of documented dSD needed to be ≥23 weeks based on IRR and Investigator's assessment.|From date of treatment start until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Cohort 1; 15 Jan 2012 and Cohort 2; 15 Apr 2013), up to approximately 2 years 8 months|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Percentage of participants||95% Confidence Interval|Number
2714872|NCT01136876|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2714873|NCT01136798|Secondary|Mean 24-h Blood Glucose Levels|Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.|baseline and after 6 weeks of treatment||||mg/dl||Standard Deviation|Mean
2714885|NCT01136772|Secondary|Changes in Psychiatric Symptoms|The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.|Baseline to 6 months|Participants with PANSS scores at 6 months|||Units on a scale||95% Confidence Interval|Mean
2714863|NCT01136967|Secondary|Disease Control Rate (DCR)|DCR, (DCR = CR + PR + SD) was defined as the percentage of participants who had a BOR of CR or PR or stable disease (SD) based on RECIST v1.1 for target lesions assessed by MRI/CT and IRR. CR was defined as the disappearance of all target lesions, any pathological lymph nodes (target or non-target) had to have a reduction in short axis to <10 mm.; PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR. SD defined as reduction in tumor volume of < 30% or an increase in the volume of 1 or more measurable lesions of < 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to disease progression. BOR of SD, time from first administration of study drug until date of documented SD needed to be >=7 weeks based on IRR and Investigator's assessment.|From date of treatment start until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Cohort 1; 15 Jan 2012 and Cohort 2; 15 Apr 2013), up to approximately 2 years 8 months|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Percentage of participants||95% Confidence Interval|Number
2714864|NCT01136967|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date for each cohort. OS was analyzed using Kaplan-Meier (1958) product-limit estimates. Data were presented with 2-sided 95% CI when an adequate number of at risk participants warranted the estimates in the table below.|From date of treatment start until date of death from any cause or up to data cutoff (Cohort 1; 15 Jan 2012 and Cohort 2; 15 Apr 2013), up to approximately 2 years 8 months|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Months||95% Confidence Interval|Median
2714865|NCT01136967|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death from any cause (whichever occurred first), as determined by IRR and Investigator based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier (1958) product-limit estimates. Data were presented with 2-sided 95% confidence interval (CI) when an adequate number of at risk participants warranted the estimates in the table below.|From date of treatment start until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Cohort 1; 15 Jan 2012 and Cohort 2; 15 Apr 2013), up to approximately 2 years 8 months|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Months||95% Confidence Interval|Median
2714866|NCT01136967|Primary|Objective Response Rate (ORR)|ORR, (ORR = CR + PR) was defined as the percentage of participants in each cohort who had a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans and independent radiologic review (IRR). A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a subsequent assessment of CR or PR at least 4 weeks later. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than (<)10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From date of treatment start until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to end of Cycle 6 (up to 24 weeks)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) included all participants who received at least 1 dose study drug.|||Percentage of participants||95% Confidence Interval|Number
2714867|NCT01136954|Secondary|Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period. Percentage change = 100% x (seizure frequency at period - seizure frequency at Study 312 baseline)/seizure frequency at Study 312 baseline.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population|||Percentage Change||Full Range|Median
2714868|NCT01136954|Secondary|Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population|||Seizures||Full Range|Median
2714869|NCT01136954|Secondary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants'parent or guardian maintained a seizure diary recording the date,number, and type of seizures the subject had. The primary analysis assessed the percent of responders from baseline in the Open Label Visit Period. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline through Week 59|Safety Population|||Percentage of Participants|||Number
2714870|NCT01136954|Primary|Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency|Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.|Week 1 through Week 59|Safety Population (all subjects who entered the study and received at least one dose of study drug)|||Participants|||Number
2714871|NCT01136915|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2,4,6,24, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2714874|NCT01136798|Secondary|Severity of Obstructive Sleep Apnea|The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea.|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2714875|NCT01136798|Secondary|Minutes of Wake After Sleep Onset During Sleep Recording|total amount of time spent awake after sleep onset and before morning awakening will be calculated|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||minutes||Standard Deviation|Mean
2714876|NCT01136798|Secondary|Sleep Efficiency During Polysomnographic Recording|Sleep efficiency will be calculated as total sleep time over total recording time.|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||percentage of total recording time||Standard Deviation|Mean
2714877|NCT01136798|Primary|Total Amount of Slow Wave Activity|Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured|baseline and after 6 weeks of treatment|The second primary outcome measure, slow-wave activity (SWA) was not collected.||||||
2714878|NCT01136798|Primary|Non-REM Slow Wave Sleep|Total minutes of non-REM sleep was measured|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||minutes||Standard Deviation|Mean
2714879|NCT01136785|Secondary|Change in 24-h Mean Level of Plasma Norepinephrine|The mean plasma norepinephrine level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean norepinephine level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory||||pg/ml||95% Confidence Interval|Mean
2714880|NCT01136785|Secondary|24-hr Profile of Plasma Growth Hormone|The mean plasma growth hormone level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory||||ng/ml||95% Confidence Interval|Mean
2714881|NCT01136785|Secondary|Change in Mean Plasma Cortisol Level From 24-h Sampling|The mean plasma cortisol level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory||||microgram/dL||95% Confidence Interval|Mean
2714882|NCT01136785|Primary|Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling|Serum insulin levels will be measured on each sample collected during 24-h sampling at baseline and at the end of the 7-day intervention. Mean insulin level over 24 hours will be calculated for each participant at baseline and at the end of the intervention. For each participant, we will calculate the change in mean insulin level from baseline.|after 1 week of therapy in the laboratory||||pmol/L||Standard Error|Mean
2714883|NCT01136785|Primary|Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours|Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy. The mean glucose level of all samples collected at baseline will be calculated for each participant. The mean glucose level of all samples collected at the end of the 7-day intervention will be calculated for each participant. For each participant, we will calculate the change in mean glucose level from baseline till end of the intervention.|change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory|Due to sensor failures, valid profiles of interstitial glucose were available in 10 participants with the active CPAP group and 4 participants in the sham CPAP group.|||mg/dL||Standard Error|Mean
2714884|NCT01136785|Primary|Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling|24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.|after 1 week of CPAP therapy in the laboratory||||mg/dl||Standard Error|Mean
2714902|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714886|NCT01136772|Primary|Efficacy Failure|Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.|24 months|All randomized participants who received an injection and attended one follow-up appointment|||participants|||Number
2714887|NCT01136746|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714888|NCT01136746|Secondary|Percentage of Participants With Documented Nosocomial Infections|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714889|NCT01136746|Secondary|Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period|Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714890|NCT01136746|Secondary|Percentage of Participants Requiring Intensive Care Unit Transfer|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714891|NCT01136746|Secondary|Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period|Treatment-emergent adverse event - any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants|||participants|||Number
2714892|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714893|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714894|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714895|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.|||hypoglycemic episodes|||Number
2714896|NCT01136746|Secondary|Length of Hospital Stay Post-randomization Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714897|NCT01136746|Secondary|TDD of Insulin (Units/kg) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714898|NCT01136746|Secondary|TDD of Insulin (Units) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714899|NCT01136746|Secondary|TDD of Insulin (Units/kg) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714900|NCT01136746|Secondary|Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714901|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714904|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714905|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714906|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714907|NCT01136746|Secondary|Mean FPG Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714908|NCT01136746|Secondary|Mean Fasting Plasma Glucose (FPG) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714909|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714910|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
2714911|NCT01136746|Secondary|Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
2714912|NCT01136746|Secondary|Mean Plasma Glucose (MPG) by Hospital Day|The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.|Day 1 up to day 7 of hospital study period|All randomized participants who had at least one post-baseline glucose measurement and a plasma glucose measurement at specified timepoint.|||mg/dL||Standard Deviation|Mean
2714913|NCT01136746|Primary|Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period|Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.|||percentage of capillary PG measurements|Participants||Number
2714914|NCT01136746|Primary|Mean Plasma Glucose (MPG) Throughout Hospital Study Period|Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2714915|NCT01136733|Secondary|Time to Cmax (Tmax) for Everolimus When Administered Alone or in Combination With Lenvatinib|Tmax for everolimus was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach the maximum concentration (Cmax) of everolimus in blood.|Phase 2: Cycle 1 Day 15|PK sub analysis set|||Hours||Full Range|Median
2714916|NCT01136733|Secondary|Maximum Concentration of Everolimus (Cmax) in Blood When Administered Alone or in Combination With Lenvatinib|Cmax for everolimus was defined as the maximum observed concentration of everolimus in blood following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured blood concentration-time curves.|Phase 2: Cycle 1 Day 15|PK sub analysis set|||ng/mL||Standard Deviation|Mean
2714917|NCT01136733|Secondary|Area Under the Blood Concentration-Time Curve From 0 to 24 Hours for Everolimus When Administered Alone or in Combination With Lenvatinib|Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for everolimus were derived from everolimus concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.|Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)|PK sub analysis set. n=8 for AUC(0-24)|||ng·hr/mL||Standard Deviation|Mean
2714918|NCT01136733|Secondary|Time to Cmax (Tmax) for Lenvatinib When Administered Alone or in Combination With Everolimus|Tmax for lenvatinib was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach maximum concentration (Cmax) of lenvatinib in plasma.|Phase 2: Cycle 1 Day 15|PK sub analysis set|||Hours||Full Range|Median
2714919|NCT01136733|Secondary|Maximum Concentration (Cmax) of Lenvatinib in Plasma When Administered Alone or in Combination With Everolimus|Cmax for lenvatinib was defined as the maximum observed concentration of lenvatinib in plasma following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured plasma concentration-time curves.|Phase 2: Cycle 1 Day 15|PK sub analysis set|||ng/mL||Standard Deviation|Mean
2714936|NCT01136408|Primary|Changes in Laboratory Test Values|The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range|12 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||participants|||Number
2714937|NCT01136408|Secondary|Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration||Week 1,4 and 12|Full Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714920|NCT01136733|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC(0-24)) for Lenvatinib When Administered Alone or in Combination With Everolimus|Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for lenvatinib were derived from lenvatinib concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.|Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)|Pharmacokinetic sub analysis set consisted of all participants who agreed to participate in the intensive PK sampling portion of Phase 2 of the study, had received at least 1 dose of study drug (lenvatinib or everolimus), and had evaluable concentration data.|||ng·hr/mL||Standard Deviation|Mean
2714921|NCT01136733|Secondary|Summary of Blood Concentrations of Everolimus for Sparse PK Sampling for Phase 1b and Phase 2|Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Whole blood concentrations of everolimus were measured and concentration data were summarized. The summary statistics at time points with one or more BLQ values were calculated by assigning zero for each BLQ value.|Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug (lenvatinib or everolimus) and had evaluable concentration data.|||ng/mL||Standard Deviation|Geometric Mean
2714922|NCT01136733|Secondary|Summary of Plasma Concentrations of Lenvatinib for Sparse Pharmacokinetic (PK) Sampling for Phase 1b and Phase 2|Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Plasma concentrations of lenvatinib were measured and concentration data were summarized. The summary statistics at time points with one or more below the limit of quantitation (BLQ) values were calculated by assigning zero for each BLQ value.|Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)|Pharmacokinetic analysis set included all participants who have received at least one dose of study drug (lenvatinib or everolimus) and have evaluable concentration data.|||ng/mL||Standard Deviation|Geometric Mean
2714923|NCT01136733|Secondary|Clinical Benefit Rate (CBR)|The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (duration of SD was greater than or equal to 23 weeks) and was based on investigator review data using RECIST 1.1. The BOR was defined as the best response recorded from the start of study treatment until discontinuation from the study. There was no requirement for confirmatory measurement of PR or CR to deem either one the BOR. The 95% CI was constructed using the method of Clopper and Pearson. CBR = CR + PR + SD greater than or equal to 23 weeks.|Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months|Full analysis set which included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2714924|NCT01136733|Secondary|Durable Stable Disease (SD) Rate|The durable SD rate was defined as the percentage of participants whose BOR was SD and the duration of SD was greater than or equal to 23 weeks. The durable SD was based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson.|Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months|Full analysis set which included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2714925|NCT01136733|Secondary|Disease Control Rate (DCR)|The DCR was defined as the percentage of participants who had a BOR of CR or PR or SD (minimum duration from randomization to SD greater than or equal to 7 weeks). Assessments were performed every 8 weeks and were based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD greater than or equal to 7 weeks.|Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months|Full analysis set which included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2714926|NCT01136733|Secondary|Phase 2: Objective Response Rate (ORR)|The ORR was defined as the percentage of participants who had the best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator, using RECIST 1.1 in the evaluation of MRI or CT scans of targeted lesions. Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease). The BOR was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR was calculated with exact 95% CIs using the method of Clopper and Pearson.|Randomization (Cycle 1 Day 1) until first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months|Full analysis set which included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2714927|NCT01136733|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time (in months) from the date of randomization until date of death from any cause. Median survival time was calculated using K-M estimate for each treatment arm and presented with 2-sided 95% CIs. Participants who were lost to follow-up or alive at the data cutoff date (10 Dec 2014) were censored at the date the participants were last known to be alive.|Randomization (Cycle 1 Day 1) until date of death from any cause, assessed up to the data cutoff date (10 Dec 2014), up to approximately 2 years and 9 months|Full analysis set which included all randomized participants.|||Months||95% Confidence Interval|Median
2714938|NCT01136408|Secondary|Anticoagulation Effects Trough 11-dehydrothromboxane B2|Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.|Week 0 and 12|Per Protocol Analysis Set|||pg/mg creatinine||Geometric Coefficient of Variation|Geometric Mean
2714939|NCT01136408|Secondary|Anticoagulation Effects Trough INR (International Normalised Ratio)|The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2714928|NCT01136733|Primary|Phase 2: Progression-Free Survival (PFS)|PFS was defined as the time (in months) from the date of first dose of study drug to the first documentation of disease progression or death, whichever occurred first. Kaplan-Meier (K-M) estimates were used to estimate median PFS, presented with 2-sided 95% confidence intervals (CIs). Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease using computed tomography (CT) or magnetic resonance imaging (MRI) and scan acquisition techniques (including use or nonuse of intravenous (IV) contrast). Tumor response was determined at the site by the investigator and radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the evaluation of the tumor assessment scans. The date of objective disease progression was defined as the earliest date of radiological disease progression. Participants removed from therapy due to clinical progression with no radiologic confirmation were censored at their last radiologic assessment date.|Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months|Full analysis set included all randomized participants.|||Months||95% Confidence Interval|Median
2714929|NCT01136733|Primary|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose|The highest dose level resulting in 0 or 1 DLT in 6 participants was to be considered the MTD of Phase 1b. Once the MTD was established, the participant cohort was expanded to a minimum of 10 participants. The MTD was confirmed by assessing DLTs during Cycle 1 and intolerable toxicities (i.e., not manageable with dose interruption and/or reduction) during Cycle 2 of therapy. Once the dose of lenvatinib/everolimus combination to be used in the succeeding Phase 2 part of the study was established, enrollment into Phase 2 was started. The RP2 dose was the same as the confirmed MTD and was used for the Phase 2 Treatment Arm A of this study.|First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)|Safety analysis set included all participants who received at least one dose of study treatment.|||mg/day|||Number
2714930|NCT01136733|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT)|A DLT was defined as either a treatment-related failure to administer greater than or equal to (>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) >= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly related to lenvatinib and/or everolimus therapy assessed during the first treatment cycle of each dose level. Higher grade indicates more severe toxicity.|First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)|Safety analysis set included all participants who received at least one dose of study treatment.|||Participants|||Number
2714931|NCT01136655|Secondary|Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug|The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|0 to 12 hours|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||pmol||95% Confidence Interval|Least Squares Mean
2714932|NCT01136655|Secondary|Maximal FEV1 During the 12-hour Study Period|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2714933|NCT01136655|Secondary|FEV1 at 12 Hours After Study Medication Inhalation|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|12 hours after dosing|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2714934|NCT01136655|Primary|Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2714940|NCT01136408|Secondary|Anticoagulation Effects Trough ECT (Ecarin Clotting Time)|The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set|||seconds||Geometric Coefficient of Variation|Geometric Mean
2714941|NCT01136408|Secondary|Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)|The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set|||seconds||Geometric Coefficient of Variation|Geometric Mean
2714942|NCT01136408|Primary|Discontinuation of the Study Drug Due to Adverse Events|Discontinuation of the study drug due to adverse events.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||participants|||Number
2714943|NCT01136408|Primary|Incidence and Severity of Adverse Events|Intensity of event is categorised as mild, moderate and severe.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||participants|||Number
2714944|NCT01136408|Secondary|Frequency (Occurrence Rates) of Death|The percentage of patients with death|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714945|NCT01136408|Secondary|Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events|The percentage of patients with other major adverse cardiac events|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714946|NCT01136408|Secondary|Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)|The percentage of patients with myocardial infarction (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714947|NCT01136408|Secondary|Frequency (Occurrence Rates) of Systemic Embolism|The percentage of patients with systemic embolism|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714948|NCT01136408|Secondary|Frequency (Occurrence Rates) of Transient Ischemic Attack|The percentage of patients with transient ischemic attack|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714949|NCT01136408|Secondary|Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)|The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714950|NCT01136408|Secondary|Frequency (Occurrence Rates) of a Composite Clinical Endpoint.|Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714951|NCT01136408|Primary|Frequency (Occurrence Rates) of Nuisance Bleeding Event|"The percentage of patients with nuisance bleeding event~Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator"|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714972|NCT01136226|Primary|Serum Testosterone Recovery|To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer|6 mos||||Months||Full Range|Mean
2714973|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC)|Change in Forced Vital Capacity percent of predicted (%FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||% predicted||Standard Deviation|Mean
2714952|NCT01136408|Primary|Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event|"The percentage of patients with clinically relevant bleeding event.~Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714953|NCT01136408|Primary|Frequency (Occurrence Rates) of Major Bleeding Event|"The percentage of patients with major bleeding event.~Major bleeding was defined as any bleed fulfilling one of the following conditions:~Fatal or life-threatening~Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)~Bleeding requiring surgical treatment~Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more~Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
2714954|NCT01136382|Secondary|Number of Withdrawals Due to Pre-defined Asthma Events|"Patients were considered to have experienced a pre-defined asthma event if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol."|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||participants|||Number
2714955|NCT01136382|Secondary|Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average|"The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, How many albuterol/salbutamol inhalations since last diary entry?"|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||inhalations per day||Standard Error|Least Squares Mean
2714956|NCT01136382|Secondary|Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average|"The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, How many albuterol/salbutamol inhalations since last diary entry?"|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||inhalations per day||Standard Error|Least Squares Mean
2714957|NCT01136382|Secondary|Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average|"Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, Did your asthma cause you to wake-up last night? If yes, patients were asked, Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep? Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period."|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||percentage of days with awakenings||Standard Error|Least Squares Mean
2714958|NCT01136382|Secondary|Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
2714974|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity (FVC)|Change in forced vital capacity (FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||Liter||Standard Deviation|Mean
2714975|NCT01136174|Secondary|Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1)|Change in forced expiratory volume in 1 second (FEV1) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||Liter||Standard Deviation|Mean
2714959|NCT01136382|Secondary|Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
2714960|NCT01136382|Secondary|Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average|FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters/second||Standard Error|Least Squares Mean
2714961|NCT01136382|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average|FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2714962|NCT01136382|Secondary|Change in Evening PEF From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters/minute||Standard Error|Least Squares Mean
2714963|NCT01136382|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters||Standard Error|Least Squares Mean
2714964|NCT01136382|Primary|Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters/minute||Standard Error|Least Squares Mean
2714965|NCT01136356|Secondary|Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.|Average mean peak sleep assessed once a week for up to 8 weeks||||units on a scale||Standard Error|Mean
2714966|NCT01136356|Secondary|Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)|"Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being None to 100 being Extremely. The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine."|Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period||||units on a scale||Full Range|Mean
2714967|NCT01136356|Primary|Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)|Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.|Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days||||units on a scale||Full Range|Mean
2714968|NCT01136291|Secondary|Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)|All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).|at the 14 and at the 40 gestational weeks||||scores on a scale||Standard Deviation|Mean
2714969|NCT01136291|Primary|Weight Gain During the Program|Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams|at the 14 to 40 gestational weeks||||kg||Standard Deviation|Mean
2714970|NCT01136291|Primary|Gestational Weight Gain|Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy|baseline and at 40 gestational weeks||||kg||Standard Deviation|Mean
2714971|NCT01136226|Secondary|Safety Assessments|Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire|6 months|data were not collected||||||
2714976|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco)|Change in Diffusing Capacity for Carbon Monoxide percent of predicted (%DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set- Only patients with valid measurements were analysed.|||% predicted||Standard Deviation|Mean
2714977|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco)|Change in diffusing capacity for carbon monoxide (DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||mL/min/mmHg||Standard Deviation|Mean
2714978|NCT01136174|Secondary|Change From Baseline in Pulse Rate|Change from baseline in pulse rate at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||bpm||Standard Deviation|Mean
2714979|NCT01136174|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||mmHg||Standard Deviation|Mean
2714980|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - With pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
2714981|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - No pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
2714982|NCT01136174|Secondary|Withdrawal Due to Adverse Event|Number of patients prematurely discontinued from trial medication due to adverse event.|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
2714983|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714984|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714985|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg Without BIBF 1120 (after lunch)|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714986|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after lunch) in the time frame mentioned.|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714987|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714988|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714989|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast)|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set-Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2715001|NCT01135992|Primary|HbA1c (Glycosylated Haemoglobin)|HbA1C at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2714990|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast) in the time frame mentioned.|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714991|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714992|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone in the time frame mentioned.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714993|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2714994|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone in the time frame mentioned.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2714995|NCT01136174|Primary|Drug-related Adverse Events|The number of patients with drug-related adverse events stratified according to pirfenidone use in each group|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
2714996|NCT01135992|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator|||episodes per 100 patient years|||Number
2714997|NCT01135992|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.|||episodes per 100 patient years|||Number
2714998|NCT01135992|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.|||events per 100 patient years|||Number
2714999|NCT01135992|Secondary|Change in Body Weight|Change from baseline in body weight after week 4 and after week 16|Week 0, Week 4, Week 16|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward)|||kg||Standard Deviation|Mean
2715000|NCT01135992|Secondary|Fasting Plasma Glucose (FPG)|FPG at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment|||mmol/L||Standard Deviation|Mean
2715002|NCT01135914|Secondary|Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12|(TTO) questionnaire was used to help determine the patients' health utility. Reported health utility represents the patients' quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision.|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included|||Units on a scale||Standard Deviation|Mean
2715003|NCT01135914|Secondary|EuroQoL (EQ-5D) Utility Score at Month 12|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1=no problems, 2=some problems and 3=extreme problems. Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health)."|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included|||Units on a scale||Standard Deviation|Mean
2715004|NCT01135914|Secondary|National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included|||Units on a Scale||Standard Deviation|Mean
2715005|NCT01135914|Secondary|Percentage of Patients Achieving Gain of Letters From Baseline in BCVA|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement.|12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with 12 month data were included|||Percentage of Patients|||Number
2715006|NCT01135914|Secondary|Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response.|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT|||Percentage of Patients|||Number
2715007|NCT01135914|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12|OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.|||um||Standard Deviation|Mean
2715008|NCT01135914|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline, 3, 6 and 9 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.|||Letters||Standard Deviation|Mean
2715070|NCT01135381|Secondary|Community Tenure|The number of days a patient spends in the home versus the hospital at 30 days.|30 days||||days||Standard Deviation|Mean
2715071|NCT01135381|Secondary|Rehospitalizations at 90 Days||90 days||||participants|||Number
2715009|NCT01135914|Primary|Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline and 12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. patients with both baseline and 12 month data were included.|||Letters||Standard Deviation|Mean
2715010|NCT01135537|Primary|Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course|ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured|100 days|Blood samples for ATG concentration determination were obtained at 0, +1, +4, +7, +14, +28, +60, +75 and +100 days post-HSCT. ATG serum concentrations were analyzed using a validated immunoassay. ATG pharmacokinetic parameters were estimated using a noncompartmental model. The relationship between HSCT outcomes|||mg/L||Standard Deviation|Mean
2715011|NCT01135524|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|52 weeks|The Extension Safety Population (N = 196) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.|||participants|||Number
2715012|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||mcg/mL||Standard Deviation|Mean
2715013|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||mcg/mL||Standard Deviation|Mean
2715014|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||Relative unit/mL||Standard Deviation|Mean
2715015|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||Relative unit/mL||Standard Deviation|Mean
2715016|NCT01135511|Other Pre-specified|Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4|"Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 4 and 8|A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.|||Participants|||Number
2715017|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||Relative unit/mL||Standard Deviation|Mean
2715018|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||mcg/mL||Standard Deviation|Mean
2715019|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715072|NCT01135381|Primary|Re-hospitalizations||During the 30days after discharge||||participants|||Number
2715444|NCT01132846|Secondary|Dyspnea Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||units on a scale * hours||Standard Deviation|Mean
2715020|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
2715021|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715022|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715023|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715024|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715025|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715026|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
2715027|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715028|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
2715029|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
2715030|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
2715031|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715032|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715033|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715034|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715035|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715036|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715037|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715038|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
2715039|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
2715040|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye|"Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.|||Percentage of positive cells||Standard Deviation|Mean
2715041|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye|"The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = value at observation minus value at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.|||Antibodies bound per cell||Standard Deviation|Mean
2715445|NCT01132846|Secondary|Change in Serum Creatinine||randomization to 72 hours||||mg/dL||Standard Deviation|Mean
2715042|NCT01135511|Secondary|Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale|"Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.|||Participants|||Number
2715043|NCT01135511|Secondary|Number of Participants With Nonocular Adverse Events (AEs) by Severity|Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.|||Participants|||Number
2715044|NCT01135511|Secondary|Number of Participants With Ocular Adverse Events (AEs)by Severity|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.|||Participants|||Number
2715045|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores|The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Participants|||Number
2715046|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Participants|||Number
2715047|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.~100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Participants|||Number
2715048|NCT01135511|Secondary|Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Percentage of participants|||Number
2715049|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715050|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].~Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715094|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Testosterone|The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.|||µg/L||Standard Deviation|Mean
2715469|NCT01132690|Secondary|Chitotriosidase|Percent change from baseline in chitotriosidase|Every 3 months for 12 months||||Percent Change from Baseline||Standard Deviation|Mean
2715051|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715052|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715053|NCT01135511|Secondary|Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Participants|||Number
2715054|NCT01135511|Secondary|Changes in the Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715055|NCT01135511|Secondary|Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Participants|||Number
2715056|NCT01135511|Secondary|Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.|||Percentage of participants|||Number
2715057|NCT01135511|Secondary|Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Millimeters||Standard Deviation|Mean
2715058|NCT01135511|Secondary|Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline|"TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Seconds||Standard Deviation|Mean
2715470|NCT01132690|Primary|Hemoglobin|median and interquartile range for change from baseline in haemoglobin|Every 3 months for 12 months||||g/dL||Inter-Quartile Range|Median
2715059|NCT01135511|Secondary|Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline|"Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715060|NCT01135511|Secondary|Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye|"Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.|||Percentage of participants|||Number
2715061|NCT01135511|Secondary|Changes in Corneal Staining Scores for Study Eye From Baseline|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2 and 4|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Units on a scale||Standard Deviation|Mean
2715062|NCT01135511|Primary|Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2715063|NCT01135498|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.|From study start up to approximately 4 years|ITT population|||months||95% Confidence Interval|Median
2715064|NCT01135498|Primary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).|From study start up to approximately 4 years|ITT population|||months||95% Confidence Interval|Median
2715065|NCT01135498|Secondary|Percentage of Participants Who Died||From study start up to approximately 4 years|ITT population|||percentage of participants|||Number
2715066|NCT01135498|Secondary|Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])|Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|From study start up to approximately 4 years|Response-Evaluable population|||percentage of participants|||Number
2715067|NCT01135498|Secondary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])|Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From study start up to approximately 4 years|Response-Evaluable population: all enrolled participants who received at least 3 cycles of treatment, had all baseline lesions evaluated at least once after receiving the third cycle (using same technique as at baseline), and were without major violations of the study protocol.|||percentage of participants|||Number
2715068|NCT01135498|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Start of study to approximately 4 years|ITT population|||percentage of participants|||Number
2715069|NCT01135420|Primary|Readiness to Attend Substance Use Disorder Continuing Care|Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.|3 months post-intervention||||units on a scale||Standard Deviation|Mean
2715073|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye|The macula lutea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715074|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye|The macula lutea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715075|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye|The retinal blood vessels of the left eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715076|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye|The retinal blood vessels of the right eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715077|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye|The optic nerve and papilla of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715078|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye|The optic nerve and papilla of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715079|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye|The retinal aspect of the left eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715080|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye|The retinal aspect of the right eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715081|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye|"The vitreous body of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715122|NCT01135134|Primary|Change From Baseline in the Total Nasal Symptom Score at 2 Weeks|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 2 weeks (or discontinuation)||||score on a scale||Standard Error|Least Squares Mean
2715082|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye|"The vitreous body of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715083|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye|"The lens of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715084|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye|"The lens of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715085|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye|The cornea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715086|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye|The cornea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715087|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Color Vision|Color vision was assessed by an Ophthalmologist and classified as normal or pathological. Pathological findings include abnormal color vision tests, color blindness and anomalous quotient. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in color vision classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715088|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Accommodation|Accommodation is the adjustment of the focal length of the eye lens to keep an object in focus on the retina as its distance from the eye varies, and is measured in diopters: Diopters = 1/(focal length).|Baseline and Year 5|Safety analysis where data were available. Last observation carried forward was utilized.|||diopters||Standard Deviation|Mean
2715089|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation With Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation with glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation with glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715090|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation without glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation without glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
2715091|NCT01135368|Secondary|Ophthalmologic Examination - Visual Acuity|Visual Acuity was measured using the Snellen eye chart at a distance of 6 meters. Acuity is expressed as a ratio of the test distance (6 M) / the distance the average eye can see the letters on a certain line of the eye chart. Visual acuity of 1 is normal; an individual with acuity of 0.5 could only recognize an object at half the distance compared to an individual with normal acuity.|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||ratio||Standard Deviation|Mean
2715092|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Follicle Stimulating Hormone|The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline.|Baseline and Year 5.|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.|||IU/L||Standard Deviation|Mean
2715093|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Luteinizing Hormone|The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.|||IU/L||Standard Deviation|Mean
2715095|NCT01135368|Secondary|Change From Baseline in Corpus Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
2715096|NCT01135368|Secondary|Change From Baseline in Antrum Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
2715097|NCT01135368|Secondary|Change From Baseline in Corpus Chronic Inflammation Score|Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe.|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||scores on a scale||Standard Deviation|Mean
2715098|NCT01135368|Secondary|Change From Baseline in Average Antrum Chronic Inflammation Score|Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||scores on a scale||Standard Deviation|Mean
2715099|NCT01135368|Secondary|Change From Baseline in Corpus Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
2715100|NCT01135368|Secondary|Change From Baseline in Antrum Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
2715101|NCT01135368|Secondary|Change From Baseline in Enterochromaffin-like Cell Hyperplasia|"Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia.~The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients."|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
2715102|NCT01135368|Primary|Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy|Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks >5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are <75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715103|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat|Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715104|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting|Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715105|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen|Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715106|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing|Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715123|NCT01135069|Primary|Improvement in Acne|Counting of acne lesions both inflammatory and non-inflammatory|12 weeks||||Percent change||Standard Deviation|Mean
2715107|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation|Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715108|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Heartburn|Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
2715109|NCT01135329|Secondary|Graft Failure|Percentage of participants who failed to engraft.|Day 60||||Participants|||Count of Participants
2715110|NCT01135329|Secondary|Incidence of Graft-versus-host-disease (GVHD)|Percentage of participants experiencing acute and chronic GVHD. Acute GVHD is graded by Przepiorka criteria. Chronic GVHD is graded by NIH consensus criteria and Seattle criteria.|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715111|NCT01135329|Secondary|Non-relapse Mortality|Percentage of participants who died due to BMT-related reasons|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715112|NCT01135329|Secondary|Incidence of Relapse|Percentage of participants experiencing disease relapse or progression|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715113|NCT01135329|Secondary|Progression-free Survival|Percentage of participants alive without disease relapse or progression.|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715114|NCT01135329|Secondary|Overall Survival|Percentage of participants alive|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715115|NCT01135329|Primary|Chimerism in CD3+ Sorted Peripheral Blood|Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood|Day 60|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715116|NCT01135329|Primary|Chimerism in Unsorted Peripheral Blood|Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.|Day 60|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
2715117|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Symptom Severity as Measured by the Patient Assessment of Gastrointestinal Disorder-Symptom Severity Index Disorders Symptom Severity Index (PAGI-SYM)|"Symptom severity as measured by the Patient Assessment of Upper Gastrointestinal Disorder- Symptom Severity Index. (PAGI-SYM)~The PAGI-SYM is compose of 20 questions.~Each question can be answered on a scale of 1-5 (below)~0 = none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe~Cumulative scores were calculated by summing all 20 questions.~The minimum cumulative scores would be 0 while the maximum cumulative score would be 100~Once we calculated the cumulative score for each participant, we took the average of all the cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.~Lower score indicates decreased symptom severity. Higher score indicates increased symptom severity."|Baseline, 4 Weeks, 8 Weeks||||units on a scale||Standard Deviation|Mean
2715118|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Quality of Life.|"Quality of life as impacted by patients with upper gastrointestinal disorders (PAGI-QOL)~The PAGI-QOl is composed of 30 questions.~Each question asks about the degree to which a patient's quality of life is impacted by upper gastrointestinal disorders.~Questions measure quality of life impact on a scale of 1-5 listed below.~0=none of the time, 1=a little of the time, 2=some of the time, 3=a good bit of the time, 4= most of the time, 5= all of time~The 30 items are summed together for a cumulative PAGI-QOL score. The minimum cumulative score is 0 and the maximum score is 150.~Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.~Lower scores indicate an improved overall quality of life. Higher scores indicate a diminished overall quality of life."|Baseline, 4 Weeks, 8 Weeks||||units on a scale||Standard Deviation|Mean
2715119|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Symptom Severity.|"Change in symptom severity over the past 2 weeks as measured by the patient reported Gastroparesis Cardinal Symptom Index (GCSI)~The GCSI is composed of 9 questions.~Each question asks about symptom severity on a scale of 1-5 listed below.~0=None 1= Very mild 2= Mild 3=Moderate 4=Severe 5= Very severe~The 9 scores are summed together for cumulative GCSI score. The minimum cumulative score is '0 and the maximum cumulative score is 45.~Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.~Higher total scores indicate higher symptom severity. Lower total scores indicate lower symptom severity."|Baseline, 4 Weeks, 8 Weeks||||units on a scale||Standard Deviation|Mean
2715120|NCT01135186|Primary|Gastric Accommodation|"Gastric Accommodation refers to the reflexive relaxation of the upper stomach after swallowing as measured by the Satiety Test at baseline, 4 weeks, and 8 weeks.~Increased gastric accommodation is considered a positive outcome."|Baseline, 4 Weeks, 8 Weeks||||ml||Standard Deviation|Mean
2715121|NCT01135134|Secondary|Change From Baseline in the Total Nasal Symptom Score at 1 Week|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 1 week||||score on a scale||Standard Error|Least Squares Mean
2715124|NCT01135017|Other Pre-specified|Overview of Adverse Events (AE)|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|All randomized and treated participants. Participants were considered according to the treatment actually received.|||participants|||Number
2715125|NCT01135017|Secondary|Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)|"Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.~Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study."|12 weeks|Modified intent-to-treat population as previously defined|||participants|||Number
2715126|NCT01135017|Secondary|Atrial Fibrillation Severity Scale (AFSS) Scores|"The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm.~AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden.~AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms."|Baseline (before randomization) and 12 weeks after randomization|Modified intent-to-treat population as previously defined|||units on a scale||Standard Deviation|Mean
2715127|NCT01135017|Secondary|Average Ventricular Rate During AF Episodes|"Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review.~The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined|||beats/min||Standard Deviation|Mean
2715128|NCT01135017|Secondary|AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment|AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab|4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined|||percent time in AF||95% Confidence Interval|Geometric Mean
2715129|NCT01135017|Primary|Atrial Fibrillation (AF) Burden During the 12-week Treatment Period|"AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator.~AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|The analysis included all randomized and treated participants with post-baseline AF burden assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).|||percent time in AF||95% Confidence Interval|Geometric Mean
2715130|NCT01134952|Secondary|Delta Triglyceride Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available on 2 patients|||percent change||Standard Deviation|Mean
2715131|NCT01134952|Secondary|Delta Cholesterol Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available for 2 patients|||percent change||Standard Deviation|Mean
2715132|NCT01134952|Secondary|Delta Platelet Count|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available on 2 patients at appropriate time|||percent change||Standard Deviation|Mean
2715133|NCT01134952|Secondary|Delta Hemoglobin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available in 2 patients|||percent change||Standard Deviation|Mean
2715134|NCT01134952|Secondary|Delta Alanine Aminotransferase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate time not available in 2 patients|||percent change||Standard Deviation|Mean
2715135|NCT01134952|Secondary|Delta Alkaline Phosphatase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available at appropriate times in 2 patients|||percent change||Standard Deviation|Mean
2715136|NCT01134952|Secondary|Delta Bilirubin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels available at correct time in only 7 patients|||percent change||Standard Deviation|Mean
2715137|NCT01134952|Secondary|Delta Tacrolimus Trough Level|Percent change determined 3 months after switch from MMF to SRL|3 month|2 patients did not have tacrolimus levels recorded during both time periods and are excluded|||percent change||Standard Deviation|Mean
2715138|NCT01134952|Secondary|Sirolimus Trough Level||3 month||||ng/ml||Standard Deviation|Mean
2715139|NCT01134952|Secondary|Final Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from SRL to MMF|3 month||||percent change||Standard Deviation|Mean
2715140|NCT01134952|Primary|Delta Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from MMF to SRL.|3 month||||percent change||Standard Deviation|Mean
2715141|NCT01134939|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for haemoglobin at baseline and at month 36.|||g/dL||Standard Deviation|Mean
2715142|NCT01134939|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for creatinine at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2715143|NCT01134939|Secondary|Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.|||U/L||Standard Deviation|Mean
2715144|NCT01134939|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for the AST at baseline and at month 36.|||U/L||Standard Deviation|Mean
2715145|NCT01134939|Secondary|Changes in the Laboratory Data ( ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.|||U/L||Standard Deviation|Mean
2715146|NCT01134939|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for blood glucose at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2715147|NCT01134939|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for triglycerides at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2715148|NCT01134939|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for LDL cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2715149|NCT01134939|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for HDL cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2715150|NCT01134939|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for total cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2715151|NCT01134939|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.|||cells/mm^3||Standard Deviation|Mean
2715152|NCT01134939|Secondary|Changes in the Viral Load After 36 Months From Baseline|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.|||Log10 copies/mL||Standard Deviation|Mean
2715153|NCT01134939|Primary|Number of Patients With Virologic Response (VR) After 36 Months|"VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.~A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml."|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.|||participants|||Number
2715154|NCT01134900|Secondary|Time to Provider Response|Time from study event to modification or discontinuation of targeted medication|Until patient discharge (~2 week average)||||Hours|Participants|Inter-Quartile Range|Median
2715155|NCT01134900|Primary|Adverse Drug Events or Potential Adverse Drug Events|Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.|Until patient discharge (~2 week average)||||Patient-Medication Pairs|Participants||Number
2715156|NCT01134887|Primary|Patient Activation Measure|Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).|12 months|Veterans participating in CHOICE study randomized to two arms: intervention or attention control. The 13-item Patient Activation Measure was administered at baseline and up to two additional times during the following 12 months. Rasch conversion of the raw PAM scores was performed to ensure the final scores were linear and interval measures.|||units on a scale||Standard Deviation|Mean
2715157|NCT01134783|Secondary|Change in Weight From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||Kg||Standard Error|Mean
2715158|NCT01134783|Secondary|Change in BMI From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||kg/m2||Standard Error|Mean
2715159|NCT01134783|Secondary|Change in Weight From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||Kg||Standard Error|Mean
2715160|NCT01134783|Secondary|Change in BMI From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||kg/m2||Standard Error|Mean
2715161|NCT01134783|Secondary|Prevalence of Overweight/Obese|The prevalence of overweight/obese between intervention and control students|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||percentage of participants|||Number
2715162|NCT01134783|Primary|Change in Body Mass Index (BMI)|The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||kg/m2||Standard Error|Mean
2715163|NCT01134731|Secondary|Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Montgomery-Asberg Depression Rating Scale will be used to measure depressive symptoms to determine the efficacy of the study drugs. It has 10 items (subscales) ranging from 0-6. Therefore the total score ranges from 0-60, with lower scores indicating better outcomes. The subscales were summed for a total score.|baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2715164|NCT01134731|Primary|Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.|baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2715165|NCT01134705|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.|Baseline and Week 6|The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
2715166|NCT01134705|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
2715179|NCT01134627|Primary|Number of Participants Who Experienced First Documented Relapse|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation = at least (>=)1 point increase in 2 functional systems/2 points increase in 1 system,either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on expanded disability status scale (EDSS) which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).|Baseline up to 96 weeks (+/- 1 week) or early termination (ET)|The Intention to Treat (ITT) population included all the participants who were randomized and received study medication.|||participants|||Number
2715167|NCT01134705|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2715168|NCT01134627|Other Pre-specified|Relapse Severity Based on Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5 and by at least 0.5 points if last EDSS was more than 5.5.|96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized to study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."|||Units on a scale||Standard Deviation|Mean
2715169|NCT01134627|Other Pre-specified|Number of Participants With Total Number of Reported Relapses (Documented and Undocumented Relapses)|Documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.|||participants|||Number
2715170|NCT01134627|Other Pre-specified|Number of Relapse Free Participants Without Progression|Analysis based on documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and overall relapses (documented and undocumented relapses); undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized and received study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."|||participants|||Number
2715171|NCT01134627|Other Pre-specified|Relapse Count|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, persisting for more than 48 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of the measure and the study was prematurely terminated.||||||
2715172|NCT01134627|Other Pre-specified|Burden of Disease|The burden of disease (BOD) is the total area of MS lesions (abnormal plaques) in the brain measured on Time Constant 1 (T1) or T2 weighted MRI.|Baseline up to 96 weeks (+/- 1 week) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.|||square millimeter (mm^2)||Standard Deviation|Mean
2715173|NCT01134627|Other Pre-specified|Percentage of Time Constant 2 (T2) Active Scans Per Participant|Inflammatory disease activity was assessed by MRI measurement of the percentage of T2 active scans.|Baseline up to 96 weeks (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.||||||
2715174|NCT01134627|Other Pre-specified|Number of Time Constant 2 (T2) Active Lesions|Inflammatory disease activity was assessed by MRI measurement of the number of T2 active lesions.|Week 48 up to Week 96 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.||||||
2715175|NCT01134627|Other Pre-specified|Number of Participants With Onset of Disability Progression|Disability progression was defined as an increase, compared to baseline evaluation of >= 1.0 points on EDSS if EDSS was >= 1.0 at baseline or >=1.5 point on EDSS if EDSS was 0.0 at baseline. EDSS assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.|||participants|||Number
2715176|NCT01134627|Secondary|Changes in Brain Volume Measured on Magnetic Resonance Imaging (MRI)|Changes in brain volume were measured as the brain parenchymal fraction using MRI scans.|Screening , final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.|||cubic millimeter (mm^3)||Standard Deviation|Mean
2715177|NCT01134627|Secondary|Number of New or Enlarging Lesions on Time Constant 2 (T2) Weighted Magnetic Resonance Imaging (MRI)|Inflammatory disease activity was assessed by MRI measurement of the number of new or enlarging T2 lesions.|Final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.|||lesions||Standard Deviation|Mean
2715178|NCT01134627|Secondary|Number of Participants With Documented Relapses|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation was >=1 point increase in 2 functional systems /2 points increase in 1 system, either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.|||participants|||Number
2715180|NCT01134614|Secondary|Proportion of Patients With Objective Response|Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2715181|NCT01134614|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.|||Months||95% Confidence Interval|Median
2715182|NCT01134614|Primary|Overall Survival|Overall survival is defined as the time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.|||Months||95% Confidence Interval|Median
2715183|NCT01134575|Primary|Number of Patients With Response|Primary endpoint for efficacy is response which is defined as: Complete Remission (CR), Complete Remission without recovery of counts (CRi) or Partial Remission (PR). Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x109/L, platelet count >100x109/L, and normal marrow differential (< 5% blasts). 8.2 Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 109/L; neutrophils < 1 x 109/L). Partial remission (PR): Peripheral blood count recovery as for CR, but with decrease in marrow blasts of > 50% and not more than 25% abnormal cells in the marrow.|After cycle 2, for up to 8 cycles||||Participants|||Count of Participants
2715184|NCT01134562|Secondary|Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide and with available data.|||percentage of AUCINF||Standard Deviation|Mean
2715185|NCT01134562|Secondary|Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide and with available data; The half-life associated with the terminal (log-linear) elimination phase values for the 40 mg dose level were not calculated due to poor log linear regression of the log concentration versus time profile during the terminal phase (r2 values <0.7).|||hr*μg/L||Standard Deviation|Mean
2715186|NCT01134562|Secondary|Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide with available data.|||hr*μg/L||Standard Deviation|Mean
2715187|NCT01134562|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide.|||μg/L||Standard Deviation|Mean
2715188|NCT01134562|Secondary|Percent Change From Baseline in Calcium Phosphorus Product||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).|Participants who were randomized and received any amount of study medication with available data at each time point.|||percent change||Standard Deviation|Mean
2715189|NCT01134562|Secondary|Percent Change From Baseline in Serum Phosphorus||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).|Participants who were randomized and received any amount of study medication with available data at each time point.|||percent change||Standard Deviation|Mean
2715190|NCT01134562|Secondary|Percent Change From Baseline in Ionized Calcium||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).|Participants who were randomized and received any amount of study medication with available data at each time point|||percent change||Standard Deviation|Mean
2715191|NCT01134562|Secondary|Percent Change From Baseline in Serum Corrected Calcium||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29|Participants who were randomized and received any amount of study medication and with available data at each time point. Only participants in Cohorts 4 and 5 had serum corrected calcium assessed on days 8, 15 and 29.|||percent change||Standard Deviation|Mean
2715192|NCT01134562|Secondary|Percent Change From Baseline in Serum Parathyroid Hormone (PTH)||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29|Participants who were randomized and received any amount of study medication with available data at each time point. Only participants in Cohorts 4 and 5 had PTH assessed on days 8, 15 and 29.|||percent change||Standard Deviation|Mean
2715193|NCT01134562|Primary|Number of Participants With Adverse Events||For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.|All participants who were randomized and received any amount of study medication.|||participants|||Number
2715194|NCT01134549|Secondary|Number of Participants With Antibodies to Etelcalcetide|Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).|Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.|Participants who received etelcalcetide|||Participants|||Count of Participants
2715195|NCT01134549|Secondary|Volume of Distribution at Steady State for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||liters||Standard Deviation|Mean
2715196|NCT01134549|Secondary|Total Body Clearance (CL) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||L/hr||Standard Deviation|Mean
2715197|NCT01134549|Secondary|Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||hours||Standard Deviation|Mean
2715198|NCT01134549|Secondary|Terminal Elimination Rate Constant (λz) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||1/hr||Standard Deviation|Mean
2715199|NCT01134549|Secondary|Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||percentage of AUCINFobs||Standard Deviation|Mean
2715200|NCT01134549|Secondary|Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||hr*μg/L||Standard Deviation|Mean
2715201|NCT01134549|Secondary|Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||hr*μg/L||Standard Deviation|Mean
2715202|NCT01134549|Secondary|Maximum Observed Concentration (Cmax) for Etelcalcetide|Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.|Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||μg/L||Standard Deviation|Mean
2715203|NCT01134549|Secondary|Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D||Baseline and 12, 24, and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
2715204|NCT01134549|Secondary|Percent Change From Baseline in Serum Calcitonin||Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
2715205|NCT01134549|Secondary|Change From Baseline in Serum Phosphate||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point|||mmol/L||Standard Deviation|Mean
2715206|NCT01134549|Secondary|Change From Baseline in Serum Corrected Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point|||mmol/L||Standard Deviation|Mean
2715207|NCT01134549|Secondary|Change From Baseline in Serum Total Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point|||mmol/L||Standard Deviation|Mean
2715208|NCT01134549|Secondary|Percent Change From Baseline in Plasma Ionized Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
2715209|NCT01134549|Secondary|Percent Change From Baseline in Serum Parathyroid Hormone||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
2715210|NCT01134549|Primary|Number of Participants With Adverse Events||From the first dose of study drug through 7 days.|The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication.|||participants|||Number
2715211|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class II|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.~DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Each DSA can have a score of 10 maximum. However, patients may have more than one DSA and points can add up to more than 10. this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant.~However, patients may have more than one DSA and points can add up to more than 10 this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant. Patients can have an infinite number of donor specific antibodies, this score can be higher than 10."|6 months|Mean Donor Specific Antibody (DSA) Class II levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.|||DSA relative intensity score||Standard Deviation|Mean
2715228|NCT01134328|Secondary|Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715212|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class I|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.~DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Each DSA can have a score of 10 maximum. However, patients may have more than one DSA and points can add up to more than 10. this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant. Patients can have an infinite number of donor specific antibodies, this score can be higher than 10."|6 months|Mean Donor Specific Antibody Class I levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.|||DSA relative intensity score||Standard Deviation|Mean
2715213|NCT01134510|Secondary|Serum Creatinine|Serum creatinine will be checked 6 months post transplant to monitor allograft function.|6 months|Mean serum creatinine levels at 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.|||mg/dl (serum cr at 6m post transplant)||Standard Deviation|Mean
2715214|NCT01134510|Primary|Post-transplant Biopsy to Identify Rejection Episodes|"Subjects will have a routine kidney biopsy 6 month after transplant to screen for episodes of acute rejection.~For purposes of this investigation, antibody-mediated rejection (AMR) is defined as follows:~Deterioration of allograft function in a high-risk transplant recipient (i.e. sensitized patient with history of Donor Specific Antibodies) measured by serum Creatinine and estimated Glomerular Filtration Rate~Association with the presence of Donor Specific Antibody (usually increasing in strength) measured by luminex techniques.~Biopsy evidence of capillaritis, inflammation and C4d deposition."|6 month|9 patients in each arm completed 6 month protocol biopsy. 1 patient in the placebo arm was withdrawn before 6M biopsy. 1 patient in treatment arm refused protocol biopsy.|||Episode of rejection|||Number
2715215|NCT01134393|Secondary|Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time||weeks 4 and 8|FAS|||Number of participants|||Number
2715216|NCT01134393|Secondary|DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements|DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg|weeks 4, 8 and 12|FAS and LOCF and with at least one post baseline HBPM measurement|||Number of participants|||Number
2715217|NCT01134393|Secondary|Percentage of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|weeks 4, 8 and 12|FAS with non-missing data|||Percentage of participants|||Number
2715218|NCT01134393|Secondary|DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|weeks 4, 8 and 12|FAS and LOCF|||Number of participants|||Number
2715219|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure||weeks 4, 8 and 12|There was no information in the Case Report Form (CRF)||||||
2715220|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate|Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.|weeks 4, 8 and 12|Treated Set (TS) with non-missing data|||bpm||Standard Deviation|Mean
2715221|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP||weeks 4, 8 and 12|FAS with non-missing data|||mmHg||Standard Deviation|Mean
2715222|NCT01134393|Secondary|BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).|Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.|Week 12|FAS and LOCF and with at least one post baseline HBPM measurement|||Number of participants|||Number
2715223|NCT01134393|Secondary|BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|4 and 8 weeks|FAS and LOCF|||Number of participants|||Number
2715224|NCT01134393|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|12 weeks|Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.|||Percentage of participants||95% Confidence Interval|Number
2715225|NCT01134328|Secondary|Tolerability of Study Medication at Visit 3|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2715226|NCT01134328|Secondary|Tolerability of Study Medication at Visit 2B|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2715227|NCT01134328|Secondary|Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715229|NCT01134328|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715230|NCT01134328|Secondary|Lid Swelling at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715231|NCT01134328|Secondary|Lid Swelling Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715232|NCT01134328|Secondary|Lid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715233|NCT01134328|Secondary|Total Redness at 8 Hours Post-Dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715234|NCT01134328|Secondary|Total Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715235|NCT01134328|Secondary|Total Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715236|NCT01134328|Secondary|Episcleral Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715237|NCT01134328|Secondary|Episcleral Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of Episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715238|NCT01134328|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715239|NCT01134328|Secondary|Ciliary Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715240|NCT01134328|Secondary|Ciliary Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715241|NCT01134328|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
2715242|NCT01134328|Primary|Conjunctival Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2715243|NCT01134328|Primary|Conjunctival Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2715244|NCT01134328|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2715245|NCT01134328|Primary|Ocular Itching at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2715246|NCT01134328|Primary|Ocular Itching at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2715247|NCT01134328|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2715248|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||g/dL||Standard Deviation|Mean
2715249|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||pg/mL||Standard Deviation|Mean
2715250|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||pg/mL||Standard Deviation|Mean
2715251|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||ng/mL||Standard Deviation|Mean
2715252|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.|||mg/dL||Standard Deviation|Mean
2715253|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.|||mEq/L||Standard Deviation|Mean
2715254|NCT01134315|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All participants|||participants|||Number
2715255|NCT01134315|Primary|Percentage of Participants With at Least One Incidence of Hypercalcemia|Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]).|||percentage of participants|||Number
2715256|NCT01134276|Secondary|Total Hospital Cost During Admission After Biliary Drainage|Total hospital cost during admission after Biliary Drainage in US dollars|during hospital stay for biliary drainage procedure||||thousands in US dollars||Standard Deviation|Mean
2715257|NCT01134276|Secondary|Change in Total Serum Bilirubin After Drainage|Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)|within 14 days after drainage||||mg/dL/day||Standard Deviation|Mean
2715258|NCT01134276|Primary|Incidence of Infectious Complications After Biliary Drainage|at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)|within 120 days after drainage||||participants|||Number
2715318|NCT01133977|Other Pre-specified|Overall Response Rate (ORR) (for Phase 2)|ORR, defined as percentage of participants with best confirmed response (complete response [CR] or partial response [PR]). A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded.|From the date of randomization until disease progression or death or up to approximately 2 years|||||||
2715259|NCT01134263|Secondary|Number of Participants With Solicited Systemic Reactions After Any Vaccination|Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: >=39.0°C (>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.|14 days post any vaccination|Analysis was performed on Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2715260|NCT01134263|Secondary|Number of Participants With Solicited Injection Site Reactions After Any Vaccination|Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: > 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.|7 days post any vaccination|Analysis was performed on Safety Analysis Set which included all participants who received the study dose, and participants were analyzed according to the treatment received. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2715261|NCT01134263|Secondary|Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine|GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.|28 days post-Injection 3|Analysis was performed on Per Protocol Analysis Set. Here, ‘number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2715262|NCT01134263|Primary|Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine|GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.|28 days post-injection 3|Analysis was performed on Per-protocol analysis set which included participants who received at least 1 dose of the study vaccine or placebo and had no protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Phase II Lot and placebo.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2715263|NCT01134198|Primary|Number of Participants With Relapse by Days 10 and 28|assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.|assessed during 8 weeks of trial, but reported for days 10 and 28 of trial|participants entering phase 2 of trial|||Participants|||Count of Participants
2715264|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2715265|NCT01134107|Other Pre-specified|Change From Baseline to 12 Week Endpoint for Each Treatment in Weight||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.|||kilograms (kg)||Standard Deviation|Mean
2715266|NCT01134107|Other Pre-specified|Hypoglycemic Episode Rate Per 30 Days|"All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||hypoglycemic episodes per 30 days||Standard Deviation|Mean
2715267|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hypoglycemic Episode|"A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).~All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||percentage of participants|||Number
2715268|NCT01134107|Other Pre-specified|Pump Complications Rate Per 30 Days|Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||pump complications per 30 days||Standard Deviation|Mean
2715292|NCT01134055|Secondary|Number of Participants That Met Criteria for Re-injection|The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection.|Up to Week 52|Intent to Treat Population|||Participants|||Count of Participants
2715269|NCT01134107|Other Pre-specified|Percentage of Participants With Pump Complications|Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||percentage of participants|||Number
2715270|NCT01134107|Other Pre-specified|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||hyperglycemic episodes per 30 days||Standard Deviation|Mean
2715271|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hyperglycemic Episode|A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||percentage of participants|||Number
2715272|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.|||Units (U) of insulin||Standard Deviation|Mean
2715273|NCT01134107|Secondary|Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%||Endpoint for each 12-week treatment period|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.|||participants|||Number
2715274|NCT01134107|Secondary|Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.|||percentage of HbA1c||Standard Deviation|Mean
2715275|NCT01134107|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.|||Units (U) of insulin||Standard Deviation|Mean
2715276|NCT01134107|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.|Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2715277|NCT01134107|Primary|Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use||Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)|All randomized participants who completed at least one post-randomization visit. Those included in the primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2715278|NCT01134081|Primary|Differences in Angiogenic Biomarkers: PDGF-BB|Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas|5 time-points: pre-surgical, week(s) 1, 2, 3 and 4|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.|||pg/mL||Standard Error|Mean
2715279|NCT01134081|Primary|Differences in Angiogenic Biomarkers|Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas|5 time-points: pre-surgical, week(s) 1, 2, 3 and 4|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.|||ng/mL|Surgical sites|Standard Error|Mean
2715280|NCT01134055|Secondary|Plasma Concentrations of Pazopanib|All participants in the eye drop containing arms had a single blood sample drawn for assessment of pazopanib plasma concentration at the Week 4, Week 24 and Week 24. The sample was drawn without restriction for the time interval between blood draw and the last dose of IP eye drops.|Week 4, Week 24 and Week 52|Safety Population. Only participants with data available at the indicated time points were analyzed.|||nanogram/milliliter||95% Confidence Interval|Mean
2715281|NCT01134055|Secondary|Number of Participants With Laboratory Data of Clinical Concern for Urine Protein|Urine Samples were collected from Day 1 to Week 28 and Week 52 for analyses. In this dipstick test, the level of protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Neg indicated no proteinuria and 3+(high positive) indicated worst proteinuria.|Day 1 to Week 28 and Week 52|Safety Population|||Participants|||Count of Participants
2715282|NCT01134055|Secondary|Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern|The Laboratory Parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Bicarbonate, Creatinine, Glucose, Hemoglobin, Lymphocytes, Platelet count, Potassium, Sodium, Thyroid Stimulating Hormone (TSH), Total Bilirubin, Total Neutrophils, Blood Urea Nitrogen (BUN) and White Blood Cell count (WBC). Number of participants with Laboratory outside of clinical concern Range were summarized here. Data of high and low from the clinical concern range has been provided here. Here 'High' denotes above normal range and 'Low' denotes below normal range for all the categories.|Up to Week 52|Safety Population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2715283|NCT01134055|Secondary|Summary of Abnormal Electrocardiogram (ECG) Findings|12-Lead ECGs were performed in triplicate and were obtained on Weeks 4 to Week 28 and Week 52. The on-treatment ECGs were used to ascertain any risk of QTc interval prolongation at extremely low pazopanib exposures compared to what was routinely observed in participants with cancer. The on-treatment ECG data collected from participants assigned to one of the control arms also provided ECG background rate data for participants not exposed to pazopanib. Participants with Clinically significant abnormal ECGs are included here.|Week 4, Week 28, Week 44 and Week 52|Safety population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2715284|NCT01134055|Secondary|Number of Participants With Vital Sign Values Outside of Clinical Concern Range|Vital signs including systolic and diastolic blood pressure and heart rate were measured throughout the study. Number of participants with vital signs outside of clinical concern Range were summarized. 'High' denotes above normal range and 'Low' denotes below normal range for all the categories. The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to Week 52|Safety Population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2715285|NCT01134055|Secondary|Summary of Intraocular Pressure Exam Findings|Intraocular pressure (IOP) measurement was done with Goldmann tonometer. Intraocular pressure was measured prior to dilating the pupil and, to account for diurnal variation, at approximately the same time of day for every visit.|Up to week 52|Safety Population|||Participants|||Count of Participants
2715286|NCT01134055|Secondary|Summary of Potentially Clinically Important Findings for Ophthalmic Examinations|Opthalmicexaminations were done on Ocular alignment and motility, pupillary function, and visual fields by confrontation. Slit-lamp biomicroscopic examination of the anterior segment structure was performed. Fundus slit-lamp biomicroscopic examination, including use of accessory diagnostic lenses, to view the vitreous, retina (including posterior pole and periphery), macula, vasculature, and optic nerve was also performed. These examinations were performed on the study eye (SE) and the Fellow eye (FE). Participants with abnormal findings are listed here.|Up to Week 52|Safety population|||Participants|||Count of Participants
2715287|NCT01134055|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Up to 52 Weeks|Safety Population|||Participants|||Count of Participants
2715288|NCT01134055|Secondary|Change in Area of Serous Sensory Retinal Detachment (SSRD)|This is an Optical coherence tomography (OCT) parameter used to manually measure thickness along any scan. OCT was performed at week 28 and week 52.|Day 1, Week 28 and Week 52|Intent to Treat Population|||mm^2||Standard Error|Least Squares Mean
2715289|NCT01134055|Secondary|Change From Baseline in the Area of Fluorescein Leakage|Fluorescein angiograms was performed at the Screening, Week 12, Week 28, and Week 52 Visits. All images, including any that were performed at the investigator's medical discretion, were transferred to the FPRC. Fluorescein was injected intravenously according to usual clinic procedures. Dose response was also examined under different aspects of re-injection, such as time to first injection, the percentage of participants that required an injection by Week 28, as well as the estimation of the probability of reinjection. FA assessments of area of fluorescein leakage, CNV area and area of CNV lesion complex were also examined for dose differentiation.|Day 1, Week 28 and Week 52|Intent to Treat Population|||mm^2||Standard Error|Least Squares Mean
2715290|NCT01134055|Secondary|Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis)|CNV is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.|Day 1, Week 28 and Week 52|Intent to Treat Population|||mm^2||Standard Error|Least Squares Mean
2715291|NCT01134055|Secondary|Change From Baseline in the Area of Choroidal Neovascularisation (CNV)|Choroidal neovascularisation is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.|Day 1, Week 28 and Week 52|Intent to Treat Population|||Millimeter (mm)^2||Standard Error|Least Squares Mean
2715319|NCT01133977|Other Pre-specified|Overall Survival (OS) (for Phase 2)|OS, defined as the time from the date of randomization until the date of death. Few events of deaths (9 events in the Lenvatinib + Dacarbazine arm and 4 events in the Dacarbazine arm) were reported to calculate the median OS or to draw conclusions regarding the OS.|From the date of randomization until death or up to approximately 2 years|||||||
2715320|NCT01133977|Other Pre-specified|Time to Progression (TTP) (for Phase 2)|TTP, defined as the time from the date of randomization until the date of progressive disease.|From the date of randomization until disease progression or death or up to approximately 2 years|||||||
2715293|NCT01134055|Secondary|Change From Baseline in Center Point Thickness (CPT) Over Time|CPT was the inner limiting membrane to the beginning of the retinal pigment epithelium (RPE) inclusive of SR fluid. The outer boundary included the outer segment of the photoreceptors and not included the RPE. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. In amendment 3, inclusion criterion number 5 was revised to remove the required quantitative OCT component. OCT examination was used to supplement FA findings and provided qualitative (presence of SR and/or IR fluid) and quantitative (a CPT that is at least 250 microns) evidence of an active subfoveal lesion. Hence data for pre and post amendment have been provided separately.|Baseline and Week 52|Intent to Treat Population|||Microns||Standard Deviation|Mean
2715294|NCT01134055|Secondary|Number of Participants Analyzed for Visual Acuity (VA) Response Over Time|VA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters.The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. This outcome measure contains the number of participants who were analyzed for VA response.|Week 52|Intent to Treat Population|||Participants|||Count of Participants
2715295|NCT01134055|Secondary|Number of Participants With BCVA Over Time|BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters.|Up to Week 52|Intent to Treat Population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2715296|NCT01134055|Secondary|Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks|The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection. Injection rate over 52 weeks was computed by taking the number of injections received divided by the number of visits for the participant. Likewise for 28 weeks it was estimated as the number of post baseline injections received divided by the number of post baseline visits at or before the week 28 visit.|Up to 52 weeks|Intent to Treat Population|||Percentage of re-injections||Standard Error|Least Squares Mean
2715297|NCT01134055|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52|BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.|Day 1 and 52 weeks|Intent to Treat Population - It consisted of all randomized participants, according to the treatment groups assigned by randomization (i.e., planned rather than the actual treatment regimen), who received at least one dose of study medication. Only participants with data available at the indicated time points were analyzed.|||Letters||Standard Error|Least Squares Mean
2715298|NCT01134042|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician's office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare issues were recorded.|From Baseline up to Week 24/Withdrawal Visit|ITT Population|||Number of visits||Standard Deviation|Mean
2715299|NCT01134042|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at Weeks 4, 12, and 24|At the end of Week 4, Week 8, and Week 24/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptoms); much less often, somewhat less often, a little less often, the same, a little more often, somewhat more often, much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2715307|NCT01134042|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 24 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and the post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.|||Liters||Standard Error|Least Squares Mean
2715300|NCT01134042|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Scores at Week 12 and Week 24|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12 and Week 24/Early Withdrawal minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
2715301|NCT01134042|Other Pre-specified|The Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 24/Early Withdrawal|ITT Population|||participants|||Number
2715302|NCT01134042|Other Pre-specified|Mean Change From Baseline in Daily Morning Trough (AM) and Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough AM/PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2715303|NCT01134042|Other Pre-specified|Change From Baseline in Weighted Mean Serial FEV1 Over 0 to 4 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 4-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.|||Liters||Standard Deviation|Mean
2715304|NCT01134042|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 24 clinic visit. The highest of 3 technically acceptable measurements was recorded.|Week 24|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 24 was performed.|||Liters||Standard Deviation|Mean
2715305|NCT01134042|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates total impairment and a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
2715306|NCT01134042|Secondary|Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication/symptoms was considered to be rescue free/symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of periods||Standard Error|Least Squares Mean
2715538|NCT01132495|Primary|Major Adverse Cardiac Event Rate (MACE)|MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.|24 Month|The primary outcome analysis was designed for Cohort A only.|||percentage of subjects with SAEs|||Number
2715308|NCT01134042|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 24 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, country, sex, age, and treatment group.The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of the study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
2715309|NCT01134016|Secondary|Safety Blood and Urine Test|"Hematology laboratory data~Biochemistry laboratory data~Urinalysis~AE; AE not including the natural progress of the underlying disease~Incidence of toxicity ≥ grade 3 according to NCI CTCAE version 4.03~Physical examination~Vital signs changes~Electrocardiogram examination results (including HR, QRS, QT, QTc, RR intervals)"|pre-screenting and every 14-day period|||||||
2715310|NCT01134016|Secondary|Number of Participants in the PP Population With Better Than SD at Target Lesion, Better Than Non-CR/Non-PD at Non-target Lesion and no New Lesion|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for overall response by CT: Judgement by total siutation of target, non-target and new lesions.~Meaning of Target lesion: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), Sum down 30% or more from target lesion baseline; Progressive Disease(PD), Sum up at least 20% from smallest value (nadir) and Absolute increase ≥ 5 mm; Stable Disease (SD), Neither enough shrinkage for PR nor enough growth for PD.~non-target lesion: CR: All non-target lesions disappeared and All lymph nodes <10 mm; Non-CR/Non-PD: Non-target lesion(s) still present and Lymph nodes ≥10 mm; PD: Unequivocal progression; New lesion :Unequivocal new cancer lesions Overall SD response should be better than SD at target lesion, better than Non-CR/Non-PD t non-target lesion and no new lesion."|pre-screening and end of treatment|Per-protocol (PP) Population: All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST).|||participants|||Number
2715311|NCT01134016|Secondary|AUC0-t on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28||||log(mg*hr/mL)||95% Confidence Interval|Mean
2715312|NCT01134016|Secondary|AUC0-t on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|within 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1||||log(mg*hr/mL)||95% Confidence Interval|Mean
2715313|NCT01134016|Secondary|Maximum Plasma Concentration After Dosing on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28||||log(mg/ml)||95% Confidence Interval|Mean
2715314|NCT01134016|Secondary|Maximum Plasma Concentration After on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1|Pharmacokinetic (PK) Population: All patients who received at least 1 dose of antroquinonol with sufficient post-dose bio-samples collected for PK profile characterization.|||Log(mg/ml)||95% Confidence Interval|Mean
2715315|NCT01134016|Secondary|Half-life Time From Overall Study|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28||||hours||Standard Deviation|Mean
2715316|NCT01134016|Secondary|Tmax After Dose|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28||||hours||Full Range|Median
2715317|NCT01134016|Primary|To Determind the Maximum Tolerable Dose for Antroquinonol|"The study design consisted of 2 phases, the accelerated titration phase and the standard titration phase.~During the accelerated titration phase, patients were enrolled in a cohort of 1 new patient for each dose level and treated for 4 weeks at that level. Any DLT or instance of MT during any 4 week treatment at any dose level led to the initiation of standard titration (3+3) phase.~If none of the first 3 patients experienced any DLT, then dose escalation proceeded for the next cohort of patients. If 1 of 3 patients developed DLT, the cohort was expanded to at most 6 patients (another 3 patients added subsequently). If exactly 1 of the 6 patients experienced DLT, then escalation to the next dose level occurred. If more than 1 patient developed DLT in any dose cohort, the dose escalation was withheld and the prior dose level was considered as the MTD unless the present dose level was level 1"|DLT is to be observed during 4 week period|Intent-to-Treat (ITT) Population: All patients who received at least 1 dose of antroquinonol.|||mg|||Number
2715358|NCT01133665|Secondary|Number of Participants With Fever Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715321|NCT01133977|Secondary|Progression Free Survival (PFS) (for Phase 2)|PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression of such participant's disease based on Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST v. 1.1) or (2) the date of such participant's death due to any cause. Progression was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions, based on Investigator assessment according to RECIST 1.1. If missing assessments, imputed dates were used in the analysis.|From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 years|All randomized participants who received at least one dose of study drug without major protocol eligibility violations were included in the Modified Intent-to-Treat (MITT) Analysis Set.|||Weeks||95% Confidence Interval|Median
2715322|NCT01133977|Primary|Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)|Safety assessments consisted of monitoring and recording all AEs, including all Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0) grades, and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Details of AEs and SAEs are provided in the reported adverse event section.|From signing of informed consent up to 30 days after the last dose, up to approximately 2 years|Safety Analysis Set: All participants enrolled in the Phase 1b and Phase 2 portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.|||Participants|||Number
2715323|NCT01133977|Primary|Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)|DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.|From Day 1 through 21 days (one cycle)|Safety Analysis Set: All participants enrolled in the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.|||Participants with DLT|||Number
2715324|NCT01133860|Secondary|in Vitro Function of Platelets Produced During Therapy in Responding Patients|in vitro platelet function will be assessed in patients achieving a platelet count of 100 x10e9/L or more at the end of the therapy|21 days or 42 days of therapy||||participants|||Number
2715325|NCT01133860|Secondary|All Types of Adverse Events|All type of adverse events were registered.Results indicate the number of participants who experience a side effect of the drug.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy||||number of participants|||Number
2715326|NCT01133860|Secondary|Bleeding Tendency Assessed by WHO Bleeding Score|The percentage of patients with bleeding diathesis (grade 1, i.e. cutaneous bleeding, or grade 2, i.e. mild blood loss, according to WHO bleeding score) was calculated at baseline and at the end of therapy. The results are expressed as the mean change in the percentage of patients with bleeding diathesis (95%CI).|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy||||participants||95% Confidence Interval|Mean
2715327|NCT01133860|Primary|Response to Drug Based on Platelet Count at the End of Therapy|The primary endpoints were the achievement of a platelet count over 100 x10e9/L or at least 3 times the baseline value (major response), or at least twice the baseline value but less than major response (minor response). The overall response to therapy is reported. Platelet count was measured at the end of therapy (21 or 42 days, see study design) by phase-contrast microscopy.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy||||percentage of participants||95% Confidence Interval|Number
2715328|NCT01133847|Secondary|Test of Silent Reading Fluency and Comprehension (TOSREC)|The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome.|Week 16, End of Active Treatment Phase|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
2715329|NCT01133847|Secondary|Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency|The TOWRE Phonemic Decoding Efficiency measures the student's fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
2715330|NCT01133847|Secondary|Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency|The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
2715355|NCT01133665|Secondary|Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715331|NCT01133847|Secondary|Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)|DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda & DiPerna, 2010).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||words read correctly per minute||Standard Deviation|Mean
2715332|NCT01133847|Secondary|Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest|The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.|Week 16, End of Active Treatment Phase|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error.|||standardized scores||Standard Error|Least Squares Mean
2715333|NCT01133847|Primary|Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest|The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
2715334|NCT01133847|Primary|Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest|The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other discrepancies in numbers are due to missing data.|||standardized scores, M=100, SD = 15||Standard Error|Least Squares Mean
2715335|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
2715336|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
2715337|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|16 weeks (end of Active Treatment phase), and follow-up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2715338|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|16 weeks (end of Active Treatment phase), and follow-up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
2715356|NCT01133665|Secondary|Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715339|NCT01133821|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form|Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF; Total Scores) describes difference in Quality of Life Scores from Baseline to Week 20; The QLESQ-SF is a self-report measure of life satisfaction, with 16 items rated from 1 (very poor) to 5 (very good) to produce a score from 0 to 80 with higher scores indicating better quality of life. In this report, we record change in scores from baseline to follow up|20 weeks|Analyzed data from participants for whom values were available both at baseline and at twenty weeks|||units on a scale||Standard Deviation|Mean
2715340|NCT01133821|Primary|Remission|Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8)|20 weeks|Intent to treat; patients were assessed weekly|||Participants|||Count of Participants
2715341|NCT01133756|Secondary|Biomarker-based Proportion of Biomarker-Progression-Free Survival (B-PFS) at Week 12, Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Week 12|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.||||||
2715342|NCT01133756|Secondary|Biomarker CA125-based Overall Response Rate (B-ORR), Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Day 1 of every cycle, at end of treatment visit and every 2 months during follow-up period for patients who complete study without progressive disease.|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.||||||
2715343|NCT01133756|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD.|Cycle 1 (21 days)|Safety analysis was evaluated based on Safety Population, defined as all subjects enrolled into the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessments following the first dose of study drug.|||Participants|||Number
2715344|NCT01133704|Secondary|Overall Survival|Subjects were followed for 3 years from the time of randomization or until death.|Time from randomization until 36 months|All randomized participants|||Months||95% Confidence Interval|Median
2715345|NCT01133704|Primary|Overall Time to Disease Progression|Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.|from randomization to 36 months||||Weeks||95% Confidence Interval|Median
2715346|NCT01133665|Secondary|Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715347|NCT01133665|Secondary|Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715348|NCT01133665|Secondary|Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715349|NCT01133665|Secondary|Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715350|NCT01133665|Secondary|Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715351|NCT01133665|Secondary|Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715352|NCT01133665|Secondary|Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715353|NCT01133665|Secondary|Number of Participants With Back Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715354|NCT01133665|Secondary|Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715359|NCT01133665|Secondary|Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 3|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715360|NCT01133665|Secondary|Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715361|NCT01133665|Secondary|Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715362|NCT01133665|Secondary|Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715363|NCT01133665|Secondary|Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715364|NCT01133665|Secondary|Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715365|NCT01133665|Secondary|Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715366|NCT01133665|Secondary|Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715367|NCT01133665|Secondary|Number of Participants With Headache Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715368|NCT01133665|Secondary|Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715369|NCT01133665|Secondary|Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715370|NCT01133665|Secondary|Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715371|NCT01133665|Secondary|Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715372|NCT01133665|Secondary|Number of Participants With Vomiting Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715373|NCT01133665|Secondary|Number of Participants With Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715374|NCT01133665|Secondary|Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715375|NCT01133665|Secondary|Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715376|NCT01133665|Secondary|Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715377|NCT01133665|Secondary|Number of Participants With Nausea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715378|NCT01133665|Secondary|Number of Participants With Anorexia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2716905|NCT01121913|Secondary|Apparent Terminal Half-life (t½.z)|Apparent terminal half-life (t½.z) of trazodone in hours|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||Hours||Standard Deviation|Mean
2715379|NCT01133665|Secondary|Number of Participants With Anemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715380|NCT01133665|Secondary|Number of Participants With Constipation Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715381|NCT01133665|Secondary|Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715382|NCT01133665|Secondary|Number of Participants With Fatigue Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
2715383|NCT01133665|Primary|Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.|Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|24 months||||months||Full Range|Median
2715384|NCT01133639|Secondary|Quantity of Narcotic Medication|Comparison of quantity of narcotic medication utilized within the two study arms|1 week|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.||||||
2715385|NCT01133639|Secondary|Adverse Events|Comparison of adverse events between the two study arms|1 week|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.||||||
2715386|NCT01133639|Secondary|Post-operative Activity Recovery|Functional Recovery Index|up to 3 months|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.||||||
2715387|NCT01133639|Primary|Osseous Healing|Radiographic assessment by a blinded board certified radiologist|3 months|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.||||||
2715388|NCT01133639|Primary|Post-Operative Pain|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.|Post-Operative Day 2|18 subjects were enrolled & completed the study. Pharmacy held the randomization table. PI left institution & was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 & all data has been destroyed.||||||
2715389|NCT01133626|Primary|The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment|"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome."|Day 0 (Baseline), Day 42|Per protocol population|||ratio||Standard Error|Geometric Mean
2715390|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in PCSK9|Serum PCSK9 concentrations were determined by using a qualified enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 15 ng/mL.|Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data|||percent change||Standard Deviation|Mean
2715391|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in LDL-C||Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data|||percent change||Standard Deviation|Mean
2715392|NCT01133522|Secondary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Evolocumab|Area under the unbound evolocumab serum concentration-time curve from time of last dose to time of last quantifiable concentration following the last dose of evolocumab.|Day 29 predose (last dose for Cohorts 3-7) and Days 36 (predose for Cohorts 1 and 2), 40, 43, 50, 57, 64, 71, 78, and 85|Pharmacokinetic analysis set with available data|||day*μg/mL||Standard Deviation|Mean
2715393|NCT01133522|Primary|Number of Participants With Anti-Evolocumab Antibodies|Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-evolocumab binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-evolocumab neutralizing antibodies|From the first dose of study drug until Day 85|Safety analysis set|||participants|||Number
2715394|NCT01133522|Secondary|Maximum Observed Plasma Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 800 ng/mL.|Day 1, predose and Days 4, 8, 15, 22, 29, 36, 40, 43, 50, 57, 64, 71, 78, and 85|The Pharmacokinetic analysis set consisted of all participants for whom at least 1 pharmacokinetic parameter or endpoint could be adequately estimated. Serum evolocumab concentrations were not detectable in Cohorts 1 and 2.|||μg/mL||Standard Deviation|Mean
2715395|NCT01133522|Primary|Number of Participants With Adverse Events|"The relationship of each adverse event to the investigational product was assessed by the investigator.~A serious adverse event (SAE) is defined as an adverse event that~is fatal~is life threatening (places the subject at immediate risk of death)~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard."|From the first dose of study drug until Day 85|Safety analysis set|||participants|||Number
2715396|NCT01133418|Secondary|Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)|Number of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy|2 months||||units on a scale||Standard Deviation|Mean
2715397|NCT01133418|Secondary|Intra-individual Variability on Go/No-Go Task|Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task|2 months||||milliseconds||Standard Deviation|Mean
2715398|NCT01133418|Primary|Clinical Global Impression - Improvement|Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.|2 months|One child in the Cognitive Training Group and one child in the Non-progressive Cognitive Training group were missing CGI data.|||units on a scale||Standard Deviation|Mean
2715399|NCT01133418|Primary|Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale|"Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0=Never; 1=Occasionally; 2=Often; 3=Very often); higher scores indicate higher severity of ADHD symptoms."|2 months||||units on a scale||Standard Deviation|Mean
2715400|NCT01133405|Secondary|Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)||Predose and up to 36 hours postdose|All participants who received at least 1 dose of LY2886721 in Part 2 and have evaluable pharmacokinetic data were included in the analysis. One participant, who experienced an adverse event before receiving study medication, was not included in the analysis.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2715401|NCT01133405|Secondary|Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)|CSF Aβ 1-40 concentration was based on the lowest observed/measured concentration (Cnadir).|Predose and up to 36 hours postdose|All participants who received at least 1 dose of LY2886721 in Part 2 and have evaluable pharmacodynamic data were included in the analysis. One participant, who experienced an adverse event before receiving study medication, was not included in the analysis.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2715402|NCT01133405|Secondary|Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)||Predose and up to 36 hours postdose|All participants who received at least 1 dose of LY2886721 in Part 2 and have evaluable pharmacokinetic data were included in the analysis. One participant, who experienced an adverse event before receiving study medication, was not included in the analysis.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2715403|NCT01133405|Secondary|Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)|Plasma concentrations of Aβ1-40 were based on the lowest observed/measured concentration (Cnadir). To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose|All participants who received at least 1 dose of LY2886721 in Part 1 and have evaluable pharmacodynamic data were included in the analysis. One participant who was entered and randomized into the study but did not undergo study procedures, was excluded from the analysis.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2715404|NCT01133405|Secondary|Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)|Pharmacokinetic AUC for LY2886721 from time 0 to infinity. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose|All participants who received at least 1 dose of LY2886721 and have evaluable pharmacokinetic data were included in the analysis. One participant in Part 2, who experienced an adverse event before receiving study medication, was not included in the analysis.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2715405|NCT01133405|Secondary|Maximum Observed Plasma Concentration (Cmax) of LY2886721|To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.|0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose|All participants who received at least 1 dose of LY2886721 and have evaluable pharmacokinetic data were included in the analysis. One participant from Part 2, who experienced an adverse event before receiving study medication, was not included in the analysis.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2715438|NCT01132846|Secondary|Global Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better/improved|Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||units on a scale * hours||Standard Deviation|Mean
2715439|NCT01132846|Secondary|Development of Cardio-renal Syndrome||Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||participants|||Number
2715440|NCT01132846|Secondary|Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio|"BUN measured in mg/dL Cystatin C measured in mg/L~No units were used in calculated the ratio"|Randomization to 72 hours||||ratio||Standard Deviation|Mean
2715406|NCT01133405|Primary|Number of Participants With Clinically Significant Effects (Adverse Events)|A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.|Predose to 10-14 days after final dose of study drug (up to 42 days)|39 of the 40 participants who were entered and randomized into the study and who had undergone study procedures were included in the safety analyses. One participant, who was entered and randomized into the study but did not undergo study procedures, was excluded from the analysis.|||Participants|||Count of Participants
2715407|NCT01133392|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.|||grams (g)||Geometric Coefficient of Variation|Geometric Mean
2715408|NCT01133392|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)|Time of maximal glucose infusion rate.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2715409|NCT01133392|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacodynamic (PD) data.|||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
2715410|NCT01133392|Secondary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]|The maximum observed insulin lispro concentration following dosing.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PK data.|||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2715411|NCT01133392|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]|Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.|0 up to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2715412|NCT01133379|Secondary|Global Subjective VAS Score at Week 6|"At Week 6, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715413|NCT01133379|Secondary|Global Subjective VAS Score at Week 4|"At Week 4, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715414|NCT01133379|Secondary|Global Subjective VAS Score at Week 2|"At Week 2, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715415|NCT01133379|Secondary|Global Subjective VAS Score at Week 1|"At Week 1, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last week when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715441|NCT01132846|Secondary|Cumulative Urinary Sodium Excretion||Randomization to 72 hours||||mmol||Standard Deviation|Mean
2715416|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 6|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715417|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715418|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715419|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 1|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715420|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 6|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715421|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715422|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715442|NCT01132846|Secondary|Change in Treatment Response|"Treatment failure including any of the following:~development of cardio-renal syndrome~worsening/persistent heart failure~significant hypotension requiring discontinuation of study drug~significant tachycardia requiring discontinuation of study drug death"|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||participants|||Number
2715443|NCT01132846|Secondary|Change in Heart Failure Status|Persistent or worsening heart failure defined as need for rescue therapy.|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||participants|||Number
2715423|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 1|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2715424|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 1|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
2715425|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
2715426|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
2715427|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 6|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
2715428|NCT01133288|Secondary|Immune Response to Yulex|A secondary study outcome is the development of an immune response to Yulex using a human IgG anti-Guayule immunoassay. The development of a detectable IgG immune response will be considered a positive study.|3 months||||ug/ml|||Number
2715429|NCT01133288|Primary|Sensitization to Yulex|The primary study outcome will be an assessment for sensitization to Yulex as determined by serological assay for Guayule-specific IgE antibodies. The development of a detectable IgE immune response will be considered a positive study.|Approximately 3 months|No participants were exposed to Yulex because the study was terminated.|||ng/ml|||Number
2715430|NCT01133275|Secondary|Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment|Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.|Up to 54 months|All participants|||participants|||Number
2715431|NCT01133275|Primary|Number of Participants With Erythroid Response|The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria.|Up to 7 months|All evaluable participants|||participants|||Number
2715432|NCT01133171|Secondary|Change in Systolic Blood Pressure||From baseline to six months||||mmHg||Standard Deviation|Mean
2715433|NCT01133171|Primary|Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk|Only the intervention patients were analyzed for this outcome.|From baseline to six-months||||percentage of patients|||Number
2715434|NCT01133158|Secondary|Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.||7 years|Only those patients who started the maintenance treatmet were analyzed for Disease-Free Survival|||months||Full Range|Median
2715435|NCT01133158|Primary|Response Rate|"The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL~Complete Remission (CR):~Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved~Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD~Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD~Progressive Disease (PD):~SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion"|7 years|Number of Participants analyzed in the Maintenance Rituximab Arm reflects all participants who received at least one dose of Rituximab during maintenance, and had available data for response during that phase|||Participants|||Count of Participants
2715436|NCT01133067|Secondary|Cost Analysis|On average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit.|2 years|Patients of lung cancer treated with curative intent and on follow up with our institution|||Indian Rupees||Standard Deviation|Mean
2715437|NCT01133067|Primary|Concurrence Between the Telephonic Interview and the Physician Assessment|The Prevalence and bias adjusted Kappa (PABAK) score for concurrence between telephonic and physician assessment of disease status of each patient at each follow up visit was analysed.|2 years||||probability||95% Confidence Interval|Number
2715446|NCT01132846|Secondary|Change in Clinical Stability- RED-ROSE|Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit|Baseline to 60 days|RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.|||participants|||Number
2715447|NCT01132846|Secondary|Worst Reported Symptom Changes-RED-ROSE|"To determine whether changes in worst reported symptom (WRS) (dyspnea, body swelling or fatigue) VAS (WRS-VAS) are related to the response to decongestive therapy as assessed by change in WRS VAS.~WRS range -100 to + 100 Higher number is better (improved)"|Change from Baseline to 72 hours|RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.|||units on a scale||Standard Deviation|Mean
2715448|NCT01132846|Secondary|Change in Weight|Change in weight from randomization to 72 hours. Secondary Endpoint|randomization to 72 hours||||lbs||Standard Deviation|Mean
2715449|NCT01132846|Primary|Cumulative Urinary Volume|The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours|Randomization to 72 hours||||mL||Standard Deviation|Mean
2715450|NCT01132846|Primary|Decongestive Changes- RED-ROSE|"To determine whether changes in pDSS or dyspnea VAS are related to the response to decongestive therapy as evidenced by fluid volume loss~Fluid volume loss is defined as cumulative urinary output minus fluid intake during the first 72 hours post randomization."|Baseline to 72 hours|RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.|||mL||Standard Deviation|Mean
2715451|NCT01132846|Primary|Change in Dyspnea Assessment (RED-ROSE Substudy)|"To determine whether the pDSS is a more sensitive index of variability in dyspnea status than the dyspnea VAS assessed without standardization of conditions at assessment as assessed by change in Dyspnea VAS.~Dyspnea VAS range -100 to + 100 Larger number is better"|Baseline to 72 hours||||units on a scale||Standard Deviation|Mean
2715452|NCT01132846|Primary|Change in Cystatin C|The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.|Randomization to 72 hours||||mg/L||Standard Deviation|Mean
2715453|NCT01132820|Other Pre-specified|VEGFA Expression on Pre-treatment Tumor Specimens|High vs low expression.|Baseline|||||||
2715454|NCT01132820|Other Pre-specified|Plasma Levels of Endogenous Circulating VEGFA, Levels of Its Endogenous Inhibitor, sFlt-1 (the Truncated, Circulating Portion of VEGFR-1), Circulating TF, and Circulating Par-4||Up to 5 years|||||||
2715455|NCT01132820|Other Pre-specified|Levels of Receptor Targets Such as VEGFR (1, 2, 3) and PDGFR||Baseline|||||||
2715456|NCT01132820|Other Pre-specified|Expression of Phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and p70S6 Kinase||Baseline|||||||
2715457|NCT01132820|Secondary|Response Without Regard to the Time of Documented Response|Complete and partial tumor response by RECIST 1.1|Tumor responses with time restriction starts at enrollment and goes to 6 months after enrollment or until pt. off study therapy,whichever occurs first. Without time restriction starts at enrollment,lasts until off study therapy, median duration = 2.63 mth|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2715458|NCT01132820|Secondary|Progression Free Survival|Time until disease progression, death, or date of last contact.|Disease that can be assessed by physical exam should be evaluated every cycle. disease assessed by imaging should be evaluated every other cycle. Time frame to determine the date of progression is from the date of enrollment up to 5 years after enrollment|All eligible and evaluable patients|||Months||90% Confidence Interval|Median
2715459|NCT01132820|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2715460|NCT01132820|Primary|Progression-free Survival (PFS) = > 6 Months|Number of participants who survived for at least 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|For disease evaluated by physical examination, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. Evaluated from time of enrollment until progression or death, up to 5 years|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2715461|NCT01132820|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.|For diesease evaluated by physical examination, response was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle from enrollment until stopping study therapy. The average time on study is 3 mnths|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2715462|NCT01132820|Primary|Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0|Adverse Events (Grade 3 or higher)|Up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
2715463|NCT01132755|Secondary|Safety of Peritoneal Lavage in Place of Laparoscopic Lavage.|Safety is measured in the number of bowel, major omental, or major vascular injuries.|2 years||||procedural injuries|||Number
2715464|NCT01132755|Primary|Number of Study Participants With Adequate Percutaneous Lavage Specimen Collection|Cytology will be performed to compare percutaneous and laparoscopic lavage results in order to determine if percutaneous lavage specimen collection is concordant with laparoscopic lavage results|2 years|76 participants underwent percutaneous and laparoscopic lavage|||Participants|||Count of Participants
2715465|NCT01132690|Secondary|Liver Volume|Liver volume measured by MRI|Baseline and Month 12||||mL||Standard Deviation|Mean
2715466|NCT01132690|Secondary|Chemokine (C-C Motif) Ligand 18 (CCL18)|Percent change from baseline in CCL18|Every 3 months for 12 months||||Percent Change from Baseline||Standard Deviation|Mean
2715467|NCT01132690|Secondary|Platelet Count|Mean and standard deviation of platelet count per cubic mm|Baseline and 12 months||||platelets per cubic mm||Standard Deviation|Mean
2715468|NCT01132690|Secondary|Spleen Volume|Spleen volume measured by MRI|Baseline and Month 12||||mL||Standard Deviation|Mean
2715471|NCT01132664|Secondary|Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll||18 months|FAS consisted of all patients who received at least 1 dose of study drug (buparlisib). PFS analysis was not done for the BM cohort population. MTD/RP2D was not established due to premature termination of the study. In the phase ll portion of the study, PFS was analyzed only in patients with known PIK3 status, thus only 26/50 patients were analyzed.|||Months||90% Confidence Interval|Median
2715472|NCT01132664|Secondary|Clinical Benefit Rate (CBR) - Phase l & ll|"CBR = patients with CR, PR or SD ≥ 24 weeks according to RECIST by the investigator.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = Disappearance of all tumor lesions; PR= >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).~CBR analysis was not done for the BM cohort population."|||Participants|||Number
2715473|NCT01132664|Secondary|Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll|"Disease control rate (DCR) = patients with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST criteria.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = disappearance of all tumor lesions; PR = >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).~CBR analysis was not done for the BM cohort population. DCR analysis was not done for the BM cohort population."|||Participants|||Number
2715474|NCT01132664|Primary|Overall Response Rate (ORR) - Phase ll|"Objective response rate (ORR) was defined as the rate of patients with best overall response (BOR) equal to complete response (CR) or partial response (PR) according to RECIST 1.0 from the Investigators review.~Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed of the disease status by imaging (i.e. CT/MRI): Complete Response (CR) = Disappearance of all tumor lesions; Partial Response (PR)= >=30% shrinkage of lesions; Overall Response (OR) = patients with CR and PR."|18 months|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib)|||Participants|||Number
2715475|NCT01132664|Primary|Dose Limiting Toxicity (DLT) - Phase l Only|Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.|cycle 1 - 28 days|The Dose–determining set (DDS) for the determination of the MTD consisted of all patients from the safety set in the dose escalation phase who had met the minimum safety evaluation requirements and the minimum exposure criterion or had experienced DLT during Cycle 1 and were discontinued. MTD analysis was done only on the phase lb group.|||Participants|||Number
2715476|NCT01132651|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and at 2 weeks||||units on a scale||Inter-Quartile Range|Median
2715477|NCT01132651|Primary|Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score|"The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality.~Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213."|Baseline and at 2 weeks||||units on a scale||Inter-Quartile Range|Median
2715478|NCT01132612|Secondary|Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial|Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment.|up to week 351|Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.|||Participants|||Count of Participants
2715479|NCT01132612|Secondary|Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)|Full analysis set (FAS): The FAS, which included all participants who entered the extension and to whom study drug was assigned, was considered for the analysis. Only those participants, who had evaluable data at a given time point, were analyzed at that time point.|||Number of participants|||Number
2715480|NCT01132612|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Safety was assessed by frequency of adverse events including serious adverse events.|up to week 351|Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.|||Participants|||Count of Participants
2715481|NCT01132547|Secondary|Pattern of Weight in the Study Population|Change from Baseline in Weight|Baseline and 8 weeks|Completers|||Kilograms||Standard Deviation|Mean
2715482|NCT01132547|Primary|Severity of Weight Loss|Change from Baseline in Weight Z score|Baseline and 8 weeks|Completers =|||Z score||Standard Deviation|Mean
2715483|NCT01132547|Primary|Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline||8 weeks|LOCF|||participants|||Number
2715484|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 78 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715485|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 52 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715486|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 26 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715487|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 12 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715488|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 6 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715489|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at Baseline|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715490|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 78 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715491|NCT01132508|Primary|Surgeons Overall Satisfaction With Norian Drillable|The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.|Surgery||||Cases|||Number
2715492|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 52 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715493|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 26 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715494|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 12 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715495|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 6 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715496|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at Baseline|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715497|NCT01132508|Secondary|Knee Function and Stability: Extension at 78 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715498|NCT01132508|Secondary|Knee Function and Stability: Extension at 52 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715499|NCT01132508|Secondary|Knee Function and Stability: Extension at 26 Week|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715500|NCT01132508|Secondary|Knee Function and Stability: Extension at 12 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715501|NCT01132508|Secondary|Knee Function and Stability: Extension at 6 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715502|NCT01132508|Secondary|Knee Function and Stability: Extension at Baseline|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715560|NCT01132144|Secondary|Endometrial Volume|The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.|||cm³||Standard Deviation|Mean
2715503|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715504|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715505|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715506|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715507|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715508|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Surgery|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715509|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Baseline|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715510|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 78 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715511|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 52 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715596|NCT01131455|Primary|CT Scan for Fusion Analysis|There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.|8 weeks post op.|||||||
2715512|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 26 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715513|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 12 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715514|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 6 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715515|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Surgery|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715516|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Baseline|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715517|NCT01132508|Secondary|Radiographic Parameters: Depression at 78 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715518|NCT01132508|Secondary|Radiographic Parameters:: Depression at 52 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715519|NCT01132508|Secondary|Radiographic Parameters: Depression at 26 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715520|NCT01132508|Secondary|Radiographic Parameters: Depression at 12 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715537|NCT01132495|Secondary|Overall MACE|Individual components of the primary end point, cardiac death, and nonurgent revascularization|3 years|For registry cohort B, 50% of the patients with an FFR >0.80 across all lesions were followed up in a registry, and therefore, cohort B group for 'No Follow-up Re-consented' arm had no follow-up result and was not included in the endpoint analysis.|||percentage of subjects|||Number
2715521|NCT01132508|Secondary|Radiographic Parameters: Depression at 6 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 week|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715522|NCT01132508|Secondary|Radiographic Parameters: Depression at Surgery|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715523|NCT01132508|Secondary|Radiographic Parameters: Depression at Baseline|"The anatomical grading parameter depression was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
2715524|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715525|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715526|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715527|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715528|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715529|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715530|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Tap|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.~A tap is an instrument used to create threads in a hole drilled in bone."|Day 0 (Date of surgery)||||Cases|||Number
2715531|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: K-wire|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.~Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures."|Day 0 (Date of surgery)||||Cases|||Number
2715532|NCT01132508|Secondary|Pain and Function Assessed With the Lysholm Knee Scale|The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.|6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)|Five major protocol violations were excluded in the efficacy analysis.|||units on a scale||Full Range|Median
2715533|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Drill|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
2715534|NCT01132508|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device||At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative||||participants|||Number
2715535|NCT01132508|Primary|Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)|Day 0 (Day of surgery)||||Cubic Centimeters||Standard Deviation|Mean
2715536|NCT01132508|Primary|Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)|Day 0 (Day of surgery)||||Minutes||Full Range|Median
2715539|NCT01132482|Secondary|Change in Lung Clearance Index|The lung clearance index (LCI) measures how long it takes for an inert gas (e.g. nitrogen) to be washed out of the lungs during relaxed tidal breathing. A higher value of the LCI indicates worse disease. LCI is calculated as the number of functional residual capacity (FRC) turnovers required to reduce the end-tidal concentration of nitrogen to 1/40th of the starting concentration and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured FRC.|Baseline and day 28|Patients with CF homozygous for the F508del mutation with mild, stable lung disease who had valid data for measure|||LCI||Standard Deviation|Mean
2715540|NCT01132482|Secondary|Change in CF Heath Related Quality of Life Questionnaire (CFQ-R)|Respiratory domain of the CFQ-R; The range of scores is 0-100, with higher scores indicating better health.|Baseline and day 28|Patients with CF homozygous for the F508del mutation with mild, stable lung disease|||units on a scale||Standard Deviation|Mean
2715541|NCT01132482|Secondary|Change in Serum Sildenafil Pharmacokinetics|Trough sildenafil levels|Baseline and day 28|Patients with CF homozygous for the F508del mutation with mild, stable lung disease|||ug/mL||Standard Deviation|Mean
2715542|NCT01132482|Secondary|Change in Pulmonary Function by Spirometry|ppFEV1|Baseline and day 28|Patients with CF homozygous for the F508del mutation with mild, stable lung disease|||% predicted||Standard Deviation|Mean
2715543|NCT01132482|Secondary|Change in Sweat Chloride Concentration by Pilocarpine Iontophoresis|Amount of chloride transport across the skin|Baseline and day 28|Patients with CF homozygous for the F508del mutation with mild, stable lung disease. One patient in the sildenafil group had insufficient sweat for analysis.|||mmol/L||Standard Deviation|Mean
2715544|NCT01132482|Secondary|Change in Chloride Conductance by NPD|Amount of chloride transport across the nasal epithelium|Baseline and day 28|Patients with CF homozygous for the F508del mutation with stable, mild lung disease|||mV||Standard Deviation|Mean
2715545|NCT01132482|Primary|Change in Sodium Conductance by Nasal Potential Difference (NPD)|Amount of sodium transported across the nasal epithelium|Baseline and day 28|Patients with CF homozygous for the F508del genotype with mild, stable lung disease|||mV||Standard Deviation|Mean
2715546|NCT01132378|Secondary|Quadriceps Strength||2 year|||||||
2715547|NCT01132378|Primary|Knee Society Score|The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain|2 year||||score||Standard Deviation|Mean
2715548|NCT01132326|Primary|Patients With Treatment-emergent Adverse Events|Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study|up to 2 years||||participants|||Number
2715549|NCT01132313|Secondary|Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment|Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment|up to 28 weeks|FAS|||Percentage of participants||95% Confidence Interval|Number
2715550|NCT01132313|Secondary|Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment|Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment|Week 4 and 12|FAS|||Percentage of participants|||Number
2715551|NCT01132313|Secondary|Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment|Part 2: Sustained virological response at 4 and 24 weeks after end of treatment|4 weeks and 24 weeks after the end of treatment, up to 64 weeks|FAS|||Percentage of participants|||Number
2715552|NCT01132313|Secondary|Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4|Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4|4 weeks|FAS|||Percentage of participants|||Number
2715553|NCT01132313|Secondary|Part 2: Time to Virological Response|Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 40 weeks|FAS|||Percentage of participants|||Number
2715554|NCT01132313|Secondary|Part 1: Time to Virological Response|Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 4 weeks|FAS|||Percentage of participants|||Number
2715555|NCT01132313|Primary|Part 3 and 4: Sustained Virological Response (SVR)|Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 36 weeks|FAS|||Percentage of participants||95% Confidence Interval|Number
2715556|NCT01132313|Primary|Part 2: Sustained Virological Response (SVR)|Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 52 weeks|FAS|||Percentage of participants|||Number
2715557|NCT01132313|Primary|Part 1: Rapid Virological Response (RVR)|Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment|4 weeks|FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2715558|NCT01132144|Secondary|Procedure Related Pain|"Pain will be assessed using a Visual Analogue Scale (VAS). We will use a 10 cm length horizontal line, anchored by word descriptors at each end: No Pain = 0 cm and Very Severe Pain = 10 cm.~This outcome will be assessed in both groups, just after endometrial injury or sham procedure."|Immediately after procedure|All women enrolled.|||cm||Standard Deviation|Mean
2715559|NCT01132144|Secondary|Three-dimensional Doppler Indices From Endometrium (VFI)|"Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) assessed from endometrium using three-dimensional Power Doppler ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.~Only VFI was reported as it is a combination of VI and FI (VFI = VI*FI/100), and currently there are several concerns about the validity of these indices.~Such indices have no scale."|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.|||index||Standard Deviation|Mean
2715671|NCT01130883|Secondary|Compliance|Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.|Day 8 - 16||||Participants|||Number
2715561|NCT01132144|Secondary|Endometrial Thickness|The maximum distance perpendicular to the inter-endometrial interface from the endometrium-myometrium interface of the anterior to the posterior wall of the uterus assessed in the sagittal plane. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.|||mm||Standard Deviation|Mean
2715562|NCT01132144|Secondary|Implantation Rate|The number of gestational sacs observed divided by the number of embryos transferred.|3 months|||||||
2715563|NCT01132144|Secondary|Miscarriage|"Loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization).~Note: All allocated women will be considered when assessing miscarriage rate."|9 months|The number of clinical pregnancies was used as denominator, since miscarriage is a harm that can only happen in pregnant women.|||Clinical pregnancies|||Number
2715564|NCT01132144|Secondary|Ongoing Pregnancy|"At least one fetus with heart beat after 12 weeks of gestational age.~Note: All allocated women will be considered when assessing ongoing pregnancy rate."|6 months||||participants|||Number
2715565|NCT01132144|Secondary|Clinical Pregnancy|"Pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.~Note: All allocated women will be considered when assessing clinical pregnancy rate."|3 months|All women enrolled.|||participants|||Number
2715566|NCT01132144|Primary|Live Birth|"The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.~Note: All allocated women will be used as denominator when assessing live birth rate."|1 year|All women enrolled.|||participants|||Number
2715567|NCT01132118|Secondary|Triglycerides|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
2715568|NCT01132118|Secondary|HDL Cholesterol|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
2715569|NCT01132118|Secondary|LDL Cholesterol|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
2715570|NCT01132118|Secondary|Total Cholesterol|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
2715571|NCT01132118|Secondary|HOMA-B|HOMA-B = (360 x Insulin)/(Glucose - 63)|Baseline and Week 8||||(mIU x dL)/(L x mg)||Standard Deviation|Mean
2715572|NCT01132118|Secondary|HOMA-IR|"We will examine the effect of HCQ on HOMA-IR during the active treatment phase compared with placebo phase.~HOMA-IR = (Glucose x insulin)/405"|Baseline and Week 8||||(mg x mIU)/(dL*L)||Standard Deviation|Mean
2715573|NCT01132118|Primary|Insulin Sensitivity Index|"We will examine the effect of HCQ on the Matsuda Insulin Sensitivity Index (ISI) during the active treatment phase compared with placebo phase.~ISI is based on insulin and glucose levels in a fasting state during an oral glucose tolerance test (OGTT) and is calculated as follows:~ISI (Matsuda) = 10000/√ G0 X I0 X Gmean X Imean~G0 - fasting plasma glucose (mg/dL) I0 - fasting plasma insulin (mIU/L) Gmean - mean plasma glucose during OGTT (mg/dL) Imean - mean plasma insulin during OGTT (mIU/L)"|Baseline and Week 8||||(dL x L)/(mg x mIU)||Standard Deviation|Mean
2715574|NCT01131884|Primary|Bone Mineral Density|Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis|1 year after enrollment|No analysis performed as there was only one patient who participated in this study||||||
2715575|NCT01131676|Secondary|Percentage of Participants With the Composite Microvascular Outcome|"Composite microvascular outcome defined as:~Initiation of retinal photocoagulation~Vitreous haemorrhage~Diabetes-related blindness, or~New or worsening nephropathy defined as:~New onset of macroalbuminuria; or~Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or~Initiation of continuous renal replacement therapy, or~Death due to renal disease. Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
2715576|NCT01131676|Secondary|Percentage of Participants With New Onset Macroalbuminuria|New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
2715577|NCT01131676|Secondary|Percentage of Participants With New Onset Albuminuria|"New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
2715578|NCT01131676|Secondary|Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)|Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS|||percentage of participants|||Number
2715579|NCT01131676|Secondary|Percentage of Participants With Silent MI|"Silent MI; defined as presence in the ECG of:~Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3~Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF)~R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect.~It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
2715580|NCT01131676|Secondary|Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris|"The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS|||percentage of participants|||Number
2715581|NCT01131676|Primary|Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.|"Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS|||percentage of participants|||Number
2715582|NCT01131585|Primary|Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12|Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.|12 months|Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months.|||Letters||Standard Deviation|Mean
2715583|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|12 month post-baseline||||units on a scale||Standard Error|Least Squares Mean
2715584|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|6 month post-baseline||||units on a scale||Standard Error|Least Squares Mean
2715585|NCT01131520|Secondary|Hair Testing|Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.|12 month post-baseline|The sample includes participants who provided usable hair testing data at baseline|||predicted probability of positive test||Standard Error|Least Squares Mean
2715586|NCT01131520|Secondary|Hair Testing|The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.|6 month post-baseline|The sample includes participants who provided usable hair testing data at baseline.|||predicted probability of positive test||Standard Error|Least Squares Mean
2715587|NCT01131520|Secondary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.|12 months post-baseline||||units on a scale||Standard Error|Least Squares Mean
2715588|NCT01131520|Secondary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.|6 month post-baseline||||units on a scale||Standard Error|Least Squares Mean
2715589|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|3 months post-baseline||||units on a scale||Standard Error|Least Squares Mean
2715590|NCT01131520|Primary|Hair Testing|The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)|3 month post-baseline|The number of participants of the total sample who agreed to provide an analyzable hair specimen. Hair testing was not available for subjects not interviewed, those who refused testing, or who were unable to provide a sufficient quantity of hair for testing.|||Participants|||Count of Participants
2715591|NCT01131520|Primary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|The ASSIST's Global Continuum of Illicit Drug Risk was used. A higher score is considered more severe risk. The scores range from 0 to 308.|3 months post-baseline||||units on a scale||Standard Error|Least Squares Mean
2715592|NCT01131507|Secondary|Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12|Participant's ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.|Baseline, Month 3, 6, 9 and 12|Safety population included all participants who received at least 1 dose of study drug. Here, 'n' specifies number of participants who were evaluable for various categories at each time point.|||growth percentile||Full Range|Median
2715593|NCT01131507|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild [minimal/no treatment and did not interfere with daily activities], moderate [resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning] and severe [interrupted participant's usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating]) with a frequency threshold of above 5% were reported.|Up to Month 12 or early termination|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2715594|NCT01131494|Primary|Oropharyngeal Swallowing Score|Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.|five weeks||||Scores on a scale||Standard Deviation|Mean
2715595|NCT01131494|Secondary|Quality of Life|Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.|five weeks||||scores in a scale||Inter-Quartile Range|Median
2715597|NCT01131312|Secondary|Percentage of Participants With Cumulative Detection of Clinical Center Histologically Confirmed Cervical Intraepithelial Neoplasia 2 (CIN2) and Above (High Grade Lesion) Over the 2 Years of the Trial.|Cumulative detection of CIN2 and above was assessed by pathologists who reviewed specimens from cervical pelvic exams (i.e. thin prep pap test, Human papillomavirus (HPV) Deoxyribonucleic acid (DNA) test, and/or colposcopy). Pathologists graded the specimens from CIN2 (moderate grade lesion) to CIN3 (high grade lesion).|up to 2 years||||percentage of particpants|||Number
2715598|NCT01131312|Primary|Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III)|A cervical exam, pap test, human papilloma virus (HPV) deoxyribonucleic acid (DNA) test, and/or colposcopy was performed to detect whether or not a participant had CINIII. CINIII is defined as moderate or severe dysplasia or abnormal cells located on the cervix that can lead to cancer.|up to 2 years||||percentage of participants|||Number
2715599|NCT01131299|Secondary|Lipoprotein Insulin Resistance Index (LIRI) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|LIRI was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|The LIRI score is a composite of six lipoprotein parameters (VLDL, HDL and LDL, and concentrations of large VLDL, large HDL and small LDL subclasses) measured by NMR spectroscopy, which may be apparent years before the onset of overt hyperglycemia. LIRI scores range from zero, the most insulin sensitive, to 100, the most insulin resistant.|||percentage||Standard Error|Mean
2715600|NCT01131299|Secondary|Serum Glucose Levels After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Serum glucose levels was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks||||mg/dL||Standard Error|Mean
2715601|NCT01131299|Secondary|Small LDL Particle Number (by NMR Spectrometry of Lipoproteins) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Small LDL particle numbers were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks||||nmol/L||Standard Error|Mean
2715602|NCT01131299|Primary|Total Serum Cholesterol Levels for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Total cholesterol levels were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks||||mg/dL||Standard Error|Mean
2715603|NCT01131260|Secondary|Number of Infants With a Major Congenital Malformation|Major congenital malformation|Delivery||||Participants|||Count of Participants
2715604|NCT01131260|Secondary|Number of Infants With Meconium Aspiration Syndrome|Meconium aspiration syndrome|Delivery through discharge||||Participants|||Count of Participants
2715605|NCT01131260|Secondary|Median Apgar Score at 5 Minutes|The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.|5 minutes after Delivery||||score on a scale||Inter-Quartile Range|Median
2715606|NCT01131260|Secondary|Number of Infants Admitted to Special Care Nursery|Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery)|Delivery and 1 month of age||||Participants|||Count of Participants
2715607|NCT01131260|Secondary|Median Length of Hospital Stay|Days of stay in the hospital|From admission to labor and delivery through hospital discharge||||Days||Inter-Quartile Range|Median
2715608|NCT01131260|Secondary|Number of Participants Experiencing Postpartum Endometritis|Postpartum endometritis|Delivery through hospital discharge||||Participants|||Count of Participants
2715609|NCT01131260|Secondary|Number of Participants Who Had a Postpartum Blood Transfusion|Blood transfusion from delivery and through hospital stay until discharge|Delivery through hospital discharge||||Participants|||Count of Participants
2715610|NCT01131260|Secondary|Number of Participants With Chorioamnionitis|Chorioamnionitis|Any time from Randomization through Delivery||||Participants|||Count of Participants
2715611|NCT01131260|Secondary|Number of Neonates With Shoulder Dystocia During Delivery|Presence of shoulder dystocia during delivery|Delivery||||Participants|||Count of Participants
2715612|NCT01131260|Secondary|Median Duration of Labor Post-randomization|Duration of labor in hours after randomization through delivery|Onset of Labor through delivery||||Hours||Inter-Quartile Range|Median
2715613|NCT01131260|Secondary|Number of Participants With an Indication for Forceps or Vacuum Delivery|Indication for delivery by forceps or vacuum|During labor through delivery||||Participants|||Count of Participants
2715614|NCT01131260|Secondary|Number of Participants by Indication for Cesarean|indication for the cesarean delivery|At any time from randomization through delivery||||Participants|||Count of Participants
2715615|NCT01131260|Secondary|Number of Participants by Delivery Method|Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean|Delivery||||Participants|||Count of Participants
2715616|NCT01131260|Primary|Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)|Neonatal encephalopathy experienced between delivery and discharge|Delivery through hospital discharge||||Participants|||Count of Participants
2715617|NCT01131260|Primary|Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)|Neonatal intubation for ventilation in the delivery room|Delivery||||Participants|||Count of Participants
2715618|NCT01131260|Primary|Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)|Umbilical-artery blood pH < = 7.05 and base deficit in extracellular fluid > = 12 mmol/liter|Delivery||||Participants|||Count of Participants
2715619|NCT01131260|Primary|Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)|Number of infants who experienced Neonatal Seizure|Birth through hospital discharge||||Participants|||Count of Participants
2715620|NCT01131260|Primary|Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)|The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. The lowest score is 0, the highest score is 10.|5 minutes after delivery||||Participants|||Count of Participants
2715621|NCT01131260|Primary|Number of Neonatal Deaths (Primary Outcome Component)|Death of the newborn between delivery and1 month of age|Delivery through1 month of age||||Participants|||Count of Participants
2715622|NCT01131260|Primary|Number of Intrapartum Fetal Deaths (Primary Outcome Component)|Death of the fetus during the intrapartum period.|During labor and through delivery of the baby||||Participants|||Count of Participants
2715623|NCT01131260|Primary|Number of Participants With Primary Composite Outcome|Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score <=3 at 5 minutes, neonatal seizure, umbilical artery blood pH <= 7.05 with base deficit >=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy|From Delivery through 1 month of age|Umbilical cord artery blood was not able to be obtained from all participants.|||Participants|||Count of Participants
2715624|NCT01131182|Secondary|Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.|||Proportion of participants|||Number
2715625|NCT01131182|Primary|Proportion of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.|||proportion of participants|||Number
2715626|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Air Optix Aqua|Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes|||eyes|Participants||Number
2715627|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Acuvue Oasys|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible, dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
2715628|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
2715629|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Acuvue Oasys|Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes|||eyes|Participants||Number
2715630|NCT01131104|Primary|30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use|Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.|30 days prior to NAION onset|All participants in the 30 day analysis set.|||Relative risk of exposure|Participant days|95% Confidence Interval|Number
2715631|NCT01131078|Secondary|Duration of Overall Complete Response|Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years|ITT Population; Only participants with a best overall response were included in the analysis.|||months||95% Confidence Interval|Median
2715632|NCT01131078|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.|||months||95% Confidence Interval|Median
2715633|NCT01131078|Secondary|Duration of Overall Response|Duration of overall response included participants who achieved a CR or PR.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2715634|NCT01131078|Secondary|Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment|Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.|Randomization, Weeks 3, 6 and 9, and 12|ITT Population; All participants with evaluable data were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2715635|NCT01131078|Secondary|Percentage of Participants With Stable Disease|Stable disease rate was the proportion of participants who achieved CR, PR, or SD.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2715636|NCT01131078|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2715637|NCT01131078|Secondary|Percentage of Participants by Best Overall Response|Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis|||percentage of participants|||Number
2715638|NCT01131078|Primary|Time to Progression (TTP)|TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only those participants with an event of disease progression or death were included in the analysis|||months||95% Confidence Interval|Median
2715639|NCT01131078|Secondary|Time to Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.|||months||95% Confidence Interval|Median
2715640|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
2715641|NCT01131078|Secondary|Time to Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.|||months||95% Confidence Interval|Median
2715642|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
2715643|NCT01131078|Secondary|Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a treatment failure event were included in the analysis.|||months||95% Confidence Interval|Median
2715644|NCT01131078|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
2715645|NCT01131078|Secondary|Overall Survival|Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with an event (death) were included in the analysis.|||months||95% Confidence Interval|Median
2715646|NCT01131078|Secondary|Percentage of Participants Who Died|Overall survival is defined as the time from date of randomization until death from any cause|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
2715647|NCT01131078|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population;|||percentage of participants|||Number
2715648|NCT01131065|Secondary|Safety and Tolerance|Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.|During and after each product administration (during the 12 month treatment period)||||participants|||Number
2715649|NCT01131065|Primary|HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)||Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12||||IU/L||Standard Deviation|Mean
2715650|NCT01131065|Primary|HBV Recurrence|HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity|First six and twelve months after liver transplantation||||participants|||Number
2715651|NCT01131052|Primary|Mean of Weekly Fasting Blood Glucose Concentration|Mean weekly blood glucose concentration at 3 months|3 months||||mg/dL||Standard Deviation|Mean
2715672|NCT01130883|Secondary|Study Drug Given as the First, Second or Third Antimicrobial Treatment|Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.|Day 0||||Participants|||Number
2715652|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.|6 months||||percent of glycosylated hemoglobin||Standard Deviation|Mean
2715653|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.|3 months||||percent of glycosylated hemoglobin||Standard Deviation|Mean
2715654|NCT01131052|Secondary|Mean of Daily Blood Glucose Concentration|Mean of daily blood glucose concentration at baseline|Baseline||||mg/dL||Standard Deviation|Mean
2715655|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.|Baseline||||percent of glycosylated hemoglobin||Standard Deviation|Mean
2715656|NCT01131052|Secondary|Mean Blood Glucose Concentration|Mean blood glucose concentration at baseline|Baseline||||mg/dL||Standard Deviation|Mean
2715657|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL|Mean weekly blood glucose concentration less than 40 mg/dL at 3 months|3 months||||percentage of participants|||Number
2715658|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL|Mean weekly blood glucose concentration less than 70 mg/dL at 3 months|3 months||||percentage of participants|||Number
2715659|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|2 week and 1 month follow-up|All eligible, dispensed eyes|||logMAR|Participants|Standard Deviation|Mean
2715660|NCT01130974|Secondary|Symptoms & Complaints|Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.|Summarized over all follow-up visits through one month|All eligible dispensed eyes, summarized over all follow-up visits through 1 month.|||units on a scale|Participants|Standard Deviation|Mean
2715661|NCT01130974|Secondary|Lens Movement|Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
2715662|NCT01130974|Secondary|Lens Centration|"Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).~Suboptimal lens centration was defined as a rating other than excellent."|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
2715663|NCT01130974|Secondary|Lens Deposits|Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
2715664|NCT01130974|Secondary|Lens Wettability|Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
2715665|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|Summarized over all visits, and dispensed visit|All eligible, dispensed eyes|||logMAR|Participants|Standard Deviation|Mean
2715666|NCT01130974|Primary|Slit Lamp Findings|Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe|Summarized over all follow-up visits through 1 month|All dispensed eyes with any slit lamp findings > grade 2|||eyes|Participants||Number
2715667|NCT01130896|Secondary|Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance|We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images|Immediately post MRI (up to 2 hours)||||Participants|||Count of Participants
2715668|NCT01130896|Primary|Patient Safety|Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)|assessed during MRI and immediate post MRI (up to 2 hours)||||Participants|||Count of Participants
2715669|NCT01130896|Primary|Device Malfunction|Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline|immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)||||Participants|||Count of Participants
2715670|NCT01130883|Secondary|Termination of Treatment Due to Noncompliance|Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.|Day 8 - 16|A total of 3128 participants were included in the analysis.|||Participants|||Number
2715673|NCT01130883|Secondary|Chest X-ray in Case of Community-Acquired Pneumonia (CAP)|Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.|Day 0|Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia.|||Participants|||Number
2715674|NCT01130883|Secondary|Auscultation|Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, auscultation findings were not reported for 38 participants at the initial visit and 116 participants at the final visit.|||Participants|||Number
2715675|NCT01130883|Secondary|Dyspnea and Its Type|Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).|Day 0, Day 8-16||||Participants|||Number
2715676|NCT01130883|Secondary|Cough and Its Character|Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)|Day 0, Day 8-16||||Participants|||Number
2715677|NCT01130883|Secondary|Bacteriological Investigation (if Available)|The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.|Day 0|Of the 3128 participants included in the analysis, 225 participants had bacteriological investigations conducted at the Initial visit (Day 0). Some participants had more than one finding.|||participants|||Number
2715678|NCT01130883|Secondary|Body Temperature|Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, body temperature was not reported for 6 participants at the Initial visit, and 14 participants at the Second visit.|||Participants|||Number
2715679|NCT01130883|Primary|Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)|"Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. Regression of chest X-ray findings were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP)."|Day 0, Day 8 - 16||||participants|||Number
2715680|NCT01130883|Primary|Disappearance or Significant Alleviation of Symptoms|"Overall therapeutic response, yes or no was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response."|Day 8 - 16|A total of 3130 participants were enrolled into the study and 3128 were included in the analysis. Two participants were excluded from the analysis as they did not meet entry criteria (2 participants were less than 18 years of age).|||Participants|||Number
2715681|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS|||mg||Standard Deviation|Mean
2715682|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS|||mg||Standard Deviation|Mean
2715683|NCT01130844|Primary|CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS|||L/h||Standard Deviation|Mean
2715684|NCT01130844|Primary|Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS|||hours||Full Range|Median
2715685|NCT01130844|Primary|Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS|||ug/L||Standard Deviation|Mean
2715686|NCT01130844|Primary|AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|PKS|||ug*h/L||Standard Deviation|Mean
2715687|NCT01130844|Primary|Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State|Clearance of a substance from the blood by the kidneys.|Over a 24-hour period starting on day 7|PKS|||L/h||Standard Deviation|Mean
2715688|NCT01130844|Primary|Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over a 24-hour period starting on day 7|PKS|||hours||Full Range|Median
2715689|NCT01130844|Primary|Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over a 24-hour period starting on day 7|PKS|||ug/L||Standard Deviation|Mean
2715690|NCT01130844|Secondary|Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State|The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.|Over a 24-hour period starting on day 7|PKS|||percentage of dose absorbed||Standard Deviation|Mean
2715691|NCT01130844|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ug*h/L||Standard Deviation|Mean
2715692|NCT01130831|Secondary|Number of Tablets Per Day||12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior|||Number of Tablets||Standard Deviation|Mean
2715693|NCT01130831|Secondary|Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||mg||Standard Deviation|Mean
2715694|NCT01130831|Secondary|Change From Baseline in Vitamin D Dose at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||ng||Standard Deviation|Mean
2715695|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate|Hypercalcemia defined as total serum calcium above 11.22 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715696|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy|Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715697|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715698|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715699|NCT01130831|Secondary|Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=38) for this outcome which does not allow for any meaningful comparison.|||percent change in vitamin D||Standard Deviation|Mean
2715700|NCT01130831|Secondary|Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=36) for this outcome which does not allow for any meaningful comparison.|||percent change in vitamin D||Standard Deviation|Mean
2715701|NCT01130831|Secondary|Percent Change From Baseline in iPTH Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in iPTH levels||Standard Deviation|Mean
2715702|NCT01130831|Secondary|Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in calcium-phosphorous||Standard Deviation|Mean
2715703|NCT01130831|Secondary|Percent Change From Baseline in Calcium Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in calcium levels||Standard Deviation|Mean
2715704|NCT01130831|Secondary|Percent Change From Baseline in Phosphorous Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in phosphorous levels||Standard Deviation|Mean
2715705|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy|iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715706|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
2715707|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715708|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715709|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
2715710|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
2715711|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
2715712|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
2715713|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
2715714|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
2715715|NCT01130740|Secondary|PHQ-8|This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.|12-months||||units on a scale||Standard Error|Mean
2715716|NCT01130740|Secondary|Short Physical Performance Test Protocol|"This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance).~The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months||||units on a scale||Standard Error|Mean
2715717|NCT01130740|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from none (0) to severe / extreme (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months|All enrolled participants were analyzed, on an intent to treat basis. One enrolled participants in the Usual Care grouped changed clinical care to an enrolled OA Intervention provider after randomization, so that participant was analyzed with the OA intervention group.|||units on a scale||Standard Error|Mean
2715718|NCT01130597|Secondary|Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline||Baseline and Day 56|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 8|||mg/g||Standard Error|Mean
2715719|NCT01130597|Secondary|Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline||Baseline and Day 28|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 4|||mg/g||Standard Error|Mean
2715720|NCT01130597|Secondary|Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day||56 Days||||percentage of participants|||Number
2715721|NCT01130597|Secondary|Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)||56 Days||||percentage of participants|||Number
2715722|NCT01130597|Secondary|Mean Change From Baseline in Serum Potassium to End of Treatment||56 Days||||mEq/L||Standard Deviation|Mean
2715723|NCT01130597|Secondary|Mean Patiromer Dose at Week 8||Up to Week 8||||grams||Standard Deviation|Mean
2715724|NCT01130597|Secondary|Mean Patiromer Dose at Week 4||Up to Week 4||||grams||Standard Deviation|Mean
2715725|NCT01130597|Secondary|Mean Patiromer Dose at Week 1||Up to Week 1||||grams||Standard Deviation|Mean
2715726|NCT01130597|Secondary|Mean Number of Patiromer Titrations||56 Days||||patiromer titrations||Standard Deviation|Mean
2715727|NCT01130597|Secondary|Median Time to First Patiromer Dose Titration||56 Days||||days||95% Confidence Interval|Median
2715728|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Downtitration||56 Days||||percentage of participants|||Number
2715729|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Uptitration||56 Days||||percentage of participants|||Number
2715730|NCT01130597|Secondary|Mean Dose of Patiromer at End of Treatment||56 Days||||grams||Standard Deviation|Mean
2715731|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment||56 Days||||percentage of participants|||Number
2715737|NCT01130532|Secondary|"Change From Week 12 to Week 16 Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 3"|"Assessed the percentage of Yes responses to the SEP diary Question 3 Did your erection last long enough for you to have successful intercourse? from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment)."|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||"percentage of yes responses"||Standard Deviation|Mean
2715738|NCT01130532|Secondary|Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Deviation|Mean
2715739|NCT01130532|Secondary|Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).|12 weeks through 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||percentage of participants|||Number
2715740|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint|The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715741|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner|The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715742|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)|Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715743|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint|The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715752|NCT01130493|Secondary|"Total On With No Troublesome Dyskinesia"|"Using a Parkinson's disease diary, subjects recorded a state of asleep, OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, or ON with troublesome dyskinesia every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.~Mean Total On with No Troublesome Dyskinesia was calculated. On Time is when medication is providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2|||hours||Standard Deviation|Mean
2715744|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient|The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715745|NCT01130532|Secondary|"Change From Baseline to 12-Week in Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 1-5"|Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||"percentage of yes responses"||Standard Error|Least Squares Mean
2715746|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score|Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715747|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715748|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
2715749|NCT01130532|Primary|Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).|Baseline through 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||percentage of participants|||Number
2715750|NCT01130493|Secondary|Subject Preference|Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.|End of Study (week 11)|Participants who completed both treatment periods|||Participants|||Count of Participants
2715751|NCT01130493|Secondary|UPDRS Part II Plus Part III|"Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.~The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility."|End of each double-blind treatment period.|Participants who completed both treatment periods|||Scores on a scale||Standard Deviation|Mean
2715753|NCT01130493|Secondary|"Total OFF Time During Waking Hours"|"Using a Parkinson's disease diary, subjects recorded a state of asleep, OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, or ON with troublesome dyskinesia every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.~Mean Total Off Time During Waking Hours was calculated. Off Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2|||hours||Standard Deviation|Mean
2715754|NCT01130493|Primary|"Percentage of OFF Time During Waking Hours"|"Using a Parkinson's disease diary, subjects recorded a state of asleep, OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, or ON with troublesome dyskinesia every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.~Mean percentage of OFF Time During Waking Hours was calculated. Off Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2|||Percent||Standard Deviation|Mean
2715755|NCT01130337|Secondary|Percentage of Participants With Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.|||percentage of participants|||Number
2715756|NCT01130337|Secondary|Percentage of Participants With Complete Tumor Resection (R0)|R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|"ITT population. Here number of participants analyzed included those who underwent surgery."|||percentage of participants||95% Confidence Interval|Number
2715757|NCT01130337|Secondary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.|||percentage of participants||95% Confidence Interval|Number
2715758|NCT01130337|Primary|Percentage of Participants With Disease-free Survival (DFS) at Month 18|DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).|Month 18|ITT population.|||percentage of participants||95% Confidence Interval|Number
2715759|NCT01130272|Secondary|Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time|Responders were participants that met both of the following criteria on the same week for at least 50% of time on study: 1) average of daily pain scores over the past week improved by ≥30% compared with baseline average in pain score, 2) ≥50% reduction in the number of days over the past week with a BSS score ≥5 compared with Baseline. Participants must also have had at least 5/7 days diary entry to be considered a responder for that week. Abdominal pain was assessed on an 11-point scale where a score of 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps to 7=watery with no solid pieces. Response rates (percentage of participants) are based on model estimates from the logistic regression.|Baseline (Week Prior to Randomization) to Weeks 1-12|ITT Analysis Set; Subjects were included in the interval of Weeks 1-4, Weeks 5-8, or Weeks 9-12 if they received at least 1 dose of study medication within that interval.|||percentage of participants|||Number
2715760|NCT01130272|Secondary|Change From Baseline in the Number of Daily Bowel Movements|Participants recorded the number of bowel movements in a daily diary at the same time each day. The number of daily bowel movements over the previous week were averaged. A negative change from Baseline indicates improvement.|Baseline (Week prior to Randomization) to Weeks 4, 8, and 12|ITT analysis set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating. Number analyzed is the number of participants with data available at the given time-point.|||bowel movements per day||Standard Deviation|Mean
2715761|NCT01130272|Secondary|Change From Baseline in Weekly BSS Scores|The patient recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=hard stool to 7=watery diarrhea. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement.|Baseline (Week prior to Randomization) to Weeks 4, 8, and 12|ITT analysis set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating. Number analyzed is the number of participants with data available at the given time-point.|||scores on a scale||Standard Deviation|Mean
2715809|NCT01129557|Secondary|Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||mm Hg||Standard Deviation|Mean
2715762|NCT01130272|Secondary|Change From Baseline in the Weekly Pain Scores|The participant recorded their worst daily pain score in a diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement.|Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12|ITT analysis set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating. Number analyzed is the number of participants with data available at the given time-point.|||scores on a scale||Standard Deviation|Mean
2715763|NCT01130272|Primary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12|Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=separate hard lumps, 2=sausage shaped but lumpy, 3=sausage-like with cracks on the surface, 4=sausage-like but smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, and 7=watery with no solid pieces.|Baseline (Week prior to Randomization) to Week 12|ITT analysis set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating.|||percentage of participants|||Number
2715764|NCT01130272|Primary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4|Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps, 2=sausage shaped but lumpy, 3=sausage-like with cracks on the surface, 4=sausage-like but smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, and 7=watery with no solid pieces.|Baseline (Week prior to Randomization) to Week 4|Intent to treat (ITT) set was defined as the 754 participants that received at least 1 dose of study drug and had baseline and at least 1 postrandomization daily pain rating and 1 postrandomization Bristol Stool Scale (BSS) rating.|||percentage of participants|||Number
2715765|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715766|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment|Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715767|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715768|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715769|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment|Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose DBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715770|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment|Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose DBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2716098|NCT01127607|Secondary|Resting Pulse|measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).|study endpoint- end of period II (between subjects trial)||||bpm||Standard Deviation|Mean
2715771|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment|Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose SBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715772|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment|Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose SBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
2715773|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for two participants in the ISM ER treatment group, therefore these participants were excluded from the multiple dose AIx analysis."|||percent||Standard Deviation|Least Squares Mean
2715774|NCT01130168|Primary|Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose AIx analysis."|||percent||Standard Deviation|Least Squares Mean
2715775|NCT01130103|Primary|Number of Participants Who Met Remission Criterion|remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1|Weeks 5,10|all participants who were randomized, with people who dropped out counted as non-remitters|||participants|||Number
2715776|NCT01130103|Secondary|Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10|Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life|weeks 0,5,10|observed data at weeks 0, 5, and 10|||units on a scale||Standard Deviation|Mean
2715777|NCT01130103|Secondary|Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms|total score at weeks 0, 5, 10|weeks 0,5,10|observed data at each time point|||units on a scale||Standard Deviation|Mean
2715778|NCT01130103|Secondary|Treatment Response at Weeks 5 and 10|"responder status: CGI-change score of 1 or 2~1=very much improved, 2= much improved"|weeks 5,10|all subjects randomized with dropouts carried forward as nonresponders|||participants|||Number
2715779|NCT01130103|Primary|Clinician Administered PTSD Scale (CAPS)|PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD|Weeks 0,5,10|all participants who were randomized|||units on a scale||Standard Deviation|Mean
2715780|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.|||ng-hr/mL||Standard Deviation|Mean
2715781|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.|||ng-hr/mL||Standard Deviation|Mean
2715782|NCT01130051|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.|||ng/mL||Standard Deviation|Mean
2716321|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2715783|NCT01129960|Primary|Change From Baseline to Endpoint in Mean Pain|"Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. Primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [0 = no pain; 10 = the most intense pain imaginable]"|baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)|FAS = Full Analysis Set (comprised all randomized subjects with mean pain score at baseline and mean score after randomization; subjects with less than 20 days of study medication of the cut-off date were excluded from the dataset, except those that prematurely withdrew; this was the primary population used in the efficacy analysis)|||units on a scale||Standard Error|Least Squares Mean
2715784|NCT01129921|Primary|Visual Analog Scale (VAS) Mean Improvement|VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.|Baseline and Year 1|All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year.|||units on a scale||Standard Deviation|Mean
2715785|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|"VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the moderate to severe categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below."|Week 6 to 12 & Year One After Sham to mild x-over|Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild.|||participants|||Number
2715786|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|"Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a mild pain score of 1-3 points and a moderate to severe pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below."|Week 6 to 12 prior to cross-over|All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis.|||participants|||Number
2715787|NCT01129882|Secondary|Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The Last Visit was defined as the last available post-baseline evaluation. A decrease in the CGI-S score indicated disease stability or improvement."|Baseline, Month 91|The Efficacy Sample comprises those participants who entered the trial and had at least 1 post-baseline efficacy evaluation.|||units on a scale||Standard Deviation|Mean
2715788|NCT01129882|Primary|Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)|"A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity.~A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module."|Baseline to Month 97 (+/- 3 days)|The Safety Sample includes all participants who received at least 1 dose of open-label aripiprazole IM depot.|||participants|||Number
2715789|NCT01129778|Secondary|Reflux Disease Questionnaire Score on Day 1 After Therapy Completion|The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60.|Day 1 after therapy period completion|Participants who completed all protocol-specified assessments were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2715790|NCT01129778|Primary|Percentage of Time Esophageal pH< 4|Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH <4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.|Days 1 and 2|Participants who completed all protocol-specified assessments were included in the analysis.|||percentage of hours||Standard Deviation|Mean
2715791|NCT01129765|Secondary|Number of Patients Experiencing a Physical Injury During Use|"After the procedure, the patient was directly examined for any of the following:~bleeding from the nostrils~disruption of the skin around the nose~increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)"|Day one, immediately|This is the total number of participants, all of whose children were examined after the procedure.|||paricipants|||Number
2715792|NCT01129765|Secondary|Number of Patients Who Were Observed to Have an Adverse Event|"While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur:~bloody nose~being sprayed in the eye with the saline~vomiting after the procedure~choking during or after the procedure~other"|Day one, immediately||||patients with an adverse event|||Number
2715810|NCT01129557|Secondary|Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months||||mmol/day||Standard Deviation|Mean
2715793|NCT01129765|Secondary|Number of Participants Who Identified the Device's User Manual as Easy to Understand|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.~The question and scale are as follows: How easy was the manual to understand?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately||||participants|||Number
2715794|NCT01129765|Primary|Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device|"'Proper use' is defined as successfully completing all of the following five steps:~Attaching wash-head to handle properly~Positioning child correctly for procedure as per the user manual's instructions~Using the device's control button correctly for both irrigation and aspiration~Placing the wash-head tip correctly at the nasal opening~Using the device for up to but not exceeding five seconds"|Day one, immediately||||participants|||Number
2715795|NCT01129765|Secondary|Number of Participants Who Found the Device to be Effective|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.~The question and scale are as follows: How well did the device remove nasal secretions?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately||||participants|||Number
2715796|NCT01129765|Secondary|Number of Participants Who Experienced Ease of Use With the Device|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. An answer of 3 or greater is considered an affirmative answer. Such responses reported along with the exact 95% confidence intervals.~The question and scale are as follows: How easy was the device to use?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|This was the total number of participants who answered this question.|||participants|||Number
2715797|NCT01129622|Secondary|Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole|The number of participants who developed short term hypoestrogenic side effects or other adverse effects of letrozole during the intake of the medication or in the following week.|Three days plus One Week following medication|All entered subjects|||Number of participants|||Number
2715798|NCT01129622|Primary|Number of Women With Reduced Breast Parenchymal Enhancement|Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc − SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.|One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement|All participants who completed two MRIs were analysed. Percentage reduction in breast enhancement compared to baseline was determined.|||Number of participants|||Number
2715799|NCT01129609|Primary|Number of Subjects With Successful Secondary Endovascular Treatment|The outcome measure is successful secondary endovascular treatment with the Talent Converter stent graft where treatment success is defined as successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit.|30 days|Number of Participants with Successful Secondary Endovascular Treatment|||Participants|||Count of Participants
2715800|NCT01129583|Secondary|Broberg Morrey Composite Elbow Function Score|Composite elbow function store that takes into account range of motion, stability, strength, and pain. Score ranges from 0 (worse possible function) to 100 (best possible function).|6 months post-op||||Score||Standard Error|Mean
2715801|NCT01129583|Secondary|Elbow Range of Motion|Elbow flexion/extension active range of motion was assessed with the use of a standard goniometer with the center placed over the lateral epicondyle and the arms aligned with the long axis of the humerus and ulna, respectively. Full extension (arm completely straight) is defined as 0 degrees, and peak flexion is measured as the angle formed by the arm and forearm compared to a full straight arm.|3 months post-op||||Degrees||Standard Error|Mean
2715802|NCT01129583|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb.~The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents no disability, while 100 represents maximum possible disability."|1 year post-op||||Scores on a Scale (0-100)||Standard Error|Mean
2715803|NCT01129557|Secondary|Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(ng/dL)||Standard Deviation|Mean
2715804|NCT01129557|Secondary|Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(ug/day)||Standard Deviation|Mean
2715805|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(mmol/day)||Standard Deviation|Mean
2715806|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(mg/day)||Standard Deviation|Mean
2715807|NCT01129557|Secondary|Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(mmol/L)||Standard Deviation|Mean
2715808|NCT01129557|Secondary|Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||mg/dL||Standard Deviation|Mean
2715811|NCT01129557|Secondary|Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months||||mmol/L||Standard Deviation|Mean
2715812|NCT01129557|Secondary|Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean urine aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months||||ug/day||Standard Deviation|Mean
2715813|NCT01129557|Secondary|Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months||||ng/dL||Standard Deviation|Mean
2715814|NCT01129557|Primary|Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.|The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.|9 months||||participants|||Number
2715815|NCT01129531|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia|Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||Score on a scale||Standard Deviation|Mean
2715816|NCT01129531|Secondary|Change From Baseline in Area of Allodynia|A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||cm^2||Standard Deviation|Mean
2715817|NCT01129531|Secondary|Change From Baseline in Area of Spontaneous Pain|A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||cm^2||Standard Deviation|Mean
2715818|NCT01129531|Primary|Change From Baseline in the Average Pain Intensity Score at Week 12|Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||Score on a scale||Standard Deviation|Mean
2715819|NCT01129440|Other Pre-specified|Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score|"Caries increment measured by the amount of change in dmfs index from baseline separately by baseline Frankl child behavior score and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs >0) separately by Frankl score.~Subgroup analyses will be performed with statistical models which have the baseline Frankl score, the intervention group, and their interaction to assess possible effect modification (i.e. moderation)."|Assessed every 12 months (plus minus 1 month)|||||||
2715820|NCT01129440|Other Pre-specified|Effect Modification of Caries Incidence and Increment by Location|"Caries increment measured by the amount of change in dmfs index from baseline separately by location and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs >0) separately by location.~Subgroup analyses will be performed with statistical models which have the location, the intervention group, and their interaction to assess possible effect modification (i.e. moderation)."|Assessed every 12 months (plus minus 1 month)|||||||
2715821|NCT01129440|Secondary|Adverse Event|Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.|every 6 months; up to 7 days after application||||Participants|||Count of Participants
2715822|NCT01129440|Secondary|Retention of Glass Ionomer Sealants|Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera|Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported||||Participants|||Count of Participants
2715823|NCT01129440|Secondary|Salivary Fluoride Level|Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children|Every 6 months (plus minus 1 month); Month 30 reported|Randomly selected subset with salivary fluoride measured|||ppm||Standard Deviation|Mean
2715824|NCT01129440|Secondary|Caries Patterns|"Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time.~Occlusal surface dmfs>0 in baseline eligible molar teeth."|Assessed every 12 months (plus or minus 1 month); Month 36 reported||||Participants|||Count of Participants
2715825|NCT01129440|Primary|Caries Increment|Caries increment by 36 months measured by the amount of change in dmfs index from baseline|Assessed every 12 months (plus or minus 1 month); Month 36 reported||||tooth surfaces||95% Confidence Interval|Mean
2715826|NCT01129440|Primary|Caries Incidence|Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs >0)|Assessed every 12 months (plus or minus 1 month); Month 36 reported||||Participants|||Count of Participants
2715827|NCT01129336|Secondary|Change From Baseline in Urine NTX by Month|NTX= N-telopeptide of type 1 collagen (nmol bce/mmol [nanomoles of bone collagen equivalents per millimole of creatinine]). Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or visit 2 value for patients who did not receive study drug.|Baseline, Month 2, Month 4|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.|||nmol bce/mmol||Standard Deviation|Mean
2716153|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.|Month 6 Visit|This analysis included all participants with complete data for the entire study.|||Percentage of participants|||Number
2715828|NCT01129336|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from the date of enrollment to the date of first documented disease progression or death due to metastatic breast cancer.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.|||Days||95% Confidence Interval|Median
2715829|NCT01129336|Secondary|Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month|Circulating tumor cells (CTCs) have been associated with poor patient prognosis and outcomes in patients receiving treatment for MBC. CTCs have been evaluated as a potential biomarker for predicting treatment effects and overall survival. Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or Visit 2 value for patients who did not receive the study drug. Percentage was calculated as the number of patients with CTC ≥5/7.5 mL against the number of patients with nonmissing CTC values (represented as 'n' in the categories).|Baseline, Month 1, 2, 4, 6, 9 and 18|"All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug. n in each category represents the number of patients with non-missing CTC values."|||Percentage of Participants||95% Confidence Interval|Number
2715830|NCT01129336|Primary|Number of Participants With Progression Free Survival (PFS)|Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.|||Participants|||Number
2715831|NCT01129284|Secondary|Sustained Remissions up to 1 Year After Discontinuing Therapy|Complete remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at last follow-up visit (6 to 12 months post treatment). Partial remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at last follow-up visit (6 to 12 months post treatment).|Up to 1 year after treatment||||participants|||Number
2715832|NCT01129284|Primary|Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)|Complete remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at month 6. Partial remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at month 6.|6 months||||participants|||Number
2715833|NCT01129245|Secondary|Peak Estradiol Level|Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.|4 cycles (approximately 4 months)|One cycle corresponds to one participant. Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.|||pg/mL||Standard Deviation|Mean
2715834|NCT01129245|Secondary|Peak Hormone Levels|Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.|4 cycles (approximately 4 months)|One cycle corresponds to one participant. Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.|||ng/mL||Standard Deviation|Mean
2715835|NCT01129245|Primary|Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase|One cycle corresponds to one participant|4 cycles (approximately 4 months)|Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.|||Participants|||Count of Participants
2715836|NCT01129206|Secondary|Correlation of FDG PET Response With Response Rate|Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.|Approximately three years|2 patients not evaluable for response applying the PERCIST criteria per PET|||patients|||Number
2715837|NCT01129206|Secondary|Overall Survival (OS)|OS was determined from the date of start of therapy to death frm any cause.|Approximately five years||||months||95% Confidence Interval|Median
2715838|NCT01129206|Secondary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Approximately three years||||months||95% Confidence Interval|Median
2715839|NCT01129206|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Approximately three years||||patients|||Number
2715840|NCT01129141|Primary|Tinnitus Functional Index|The TFI served as the primary outcome measure. The TFI is a 25-item self-report questionnaire that has documented validity both for scaling the severity and negative impact of tinnitus, and for measuring treatment-related changes in tinnitus (responsiveness) (Meikle et al., 2012). The total score for the TFI ranges from 0 to 100, with higher scores indicating greater problems with tinnitus. The TFI has excellent internal consistency (Cronbach's α = .97) and high test-retest reliability (r = .86) (Meikle et al., 2012). The authors of the TFI estimated that a 13-point decrease on the TFI for an individual is likely to reflect a change that feels meaningful to the person.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2715841|NCT01129128|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared|1- 30 days after starting study medication|Participants who received at least one dose of study medication|||participants|||Number
2715842|NCT01129128|Secondary|Peak Level IL-2|Highest level of IL-2 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
2715843|NCT01129128|Secondary|Peak Level Interferon Gamma|Highest level of Interferon gamma while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
2715844|NCT01129128|Secondary|Peak Level IL-6|Highest level of IL-6 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
2715845|NCT01129128|Primary|Peak Level of TNF Alpha|Highest level of TNF alpha while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
2715846|NCT01129115|Primary|Change in Physical Performance Test|The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.|26 Week||||units on a scale||Standard Deviation|Mean
2715847|NCT01129115|Primary|Change in Maximal Oxygen Consumption|Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness|26 weeks||||ml/kg/min||Standard Deviation|Mean
2715848|NCT01129115|Secondary|Reasoning|"Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks||||units on a scale||Standard Error|Mean
2715849|NCT01129115|Secondary|Set Maintenance & Shifting|"Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks||||units on a scale||Standard Error|Mean
2715850|NCT01129115|Secondary|Simple Attention|"Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks||||units on a scale||Standard Error|Mean
2715851|NCT01129115|Primary|Visuospatial Processing|"Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 weeks||||units on a scale||Standard Error|Mean
2715852|NCT01129115|Secondary|Verbal Memory|"Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance.Negative numbers indicate worsening performance."|26 weeks|Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels.|||units on a standardized scale||Standard Error|Mean
2715853|NCT01129102|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks|This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group.|||units on a scale||Standard Deviation|Mean
2715958|NCT01128621|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Part B)|ECGs were taken at Screening, pre-breakfast on Day -1 and at Follow-up. On Days 1, 7 and 14 ECGs were taken pre-breakfast (fasting) and at 1, 2, 4, 6, 8, 12 and 24hours post-dose. Triplicate ECGs were taken at the pre-breakfast time point, and single assessments were taken at all other times. ECGs were taken in supine position. The data has been presented as abnormal- not clinically significant (NCS) and abnormal-clinically significant (CS).|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2715854|NCT01129102|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.|||units on a scale||Standard Deviation|Mean
2715855|NCT01129011|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
2715856|NCT01129011|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
2715857|NCT01129011|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|Baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
2715858|NCT01129011|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat Population|||Participants|||Number
2715859|NCT01129011|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population|||participants|||Number
2715860|NCT01129011|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population|||Participants|||Number
2715861|NCT01129011|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intent to Treat (ITT) Population|||Participants|||Number
2715862|NCT01129011|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population|||Participants|||Number
2715863|NCT01129011|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||Participants|||Number
2715864|NCT01128972|Other Pre-specified|Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent SMH||Standard Error|Least Squares Mean
2715865|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent NER||Standard Error|Least Squares Mean
2715866|NCT01128972|Other Pre-specified|Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent SMH||Standard Error|Least Squares Mean
2715867|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent NER||Standard Error|Least Squares Mean
2715868|NCT01128972|Secondary|Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period.|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent SMH||Standard Error|Least Squares Mean
2715869|NCT01128972|Primary|Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent NER||Standard Error|Least Squares Mean
2715870|NCT01128959|Primary|Adverse Events||Baseline to after last iv dose on day 4|All Patients Treated Set|||Number of adverse events|||Number
2715871|NCT01128946|Secondary|Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.|||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Mean
2715872|NCT01128946|Secondary|%SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group|||Percentage||Standard Error|Mean
2715873|NCT01128946|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/(D-B)]*100.|Baseline to 14 days|Per Protocol (PP) population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.|||Percentage of SMHR||Standard Error|Mean
2715874|NCT01128894|Secondary|Mean Change From Baseline in Body Weight at Week 32|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.|||Kilograms||Standard Deviation|Mean
2715875|NCT01128894|Secondary|Time to Hyperglycemia Rescue at Week 32|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.|Week 32|ITT Population|||Weeks||95% Confidence Interval|Median
2715876|NCT01128894|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32|Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 32|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
2715877|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2715878|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2715879|NCT01128894|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2715880|NCT01128894|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 32|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2715881|NCT01128842|Primary|Tolerated Dose|"Six subjects will be initially enrolled (neratinib 240 mg/day; capecitabine 1500 mg/m²/day on days 1 through 14). AEs and DLTs will be assessed from the first dose of investigational product through day 21. Based on the DLT rate in these first 6 subjects, dose tolerability will be confirmed as follows:~If ≤1 of the first 6 evaluable subjects experience a DLT by day 21, then this dose is considered tolerable, and enrollment will stop.~If ≥3 of the first 6 evaluable subjects experience a DLT by day 21, this dose is considered intolerable.~If 2 of the first 6 evaluable subjects experience a DLT by day 21, then an additional 4 subjects will be enrolled at the same dose level.~If a total of 10 subjects are enrolled, then the tolerability will be confirmed as follows:~If ≤3 of the total 10 subjects experience a DLT by day 21, then this dose will be considered tolerable.~If ≥4 of the total 10 subjects experience a DLT by day 21, then the dose will be considered intolerable."|From first dose date to day 21.|The safety population was defined as all subjects who received at least 1 dose of investigational product (neratinib and/or capecitabine).|||mg|||Number
2715882|NCT01128842|Secondary|Maximum Plasma Concentration of Neratinib in Combination With Capecitabine|Maximum plasma concentration (nanograms/milliliter) of Neratinib at day 14 following Administration of Neratinib 240 mg in combination with Capecitabine 1500 mg/m^2 per day to Japanese Subjects with Cancer.|Measured at 1, 2, 4, 6, 8 and 21-24 hours after dose on day 14.|The pharmacokinetic population was defined as all subjects who received at least 1 dose of investigational product (neratinib and/or capecitabine).|||ng/mL||Standard Deviation|Mean
2715883|NCT01128842|Secondary|Area Under the Curve (AUC) of Neratinib in Combination With Capecitabine|AUC of Neratinib at day 14 following Administration of Neratinib 240 mg in combination with Capecitabine 1500 mg/m^2 per day to Japanese Subjects with Cancer.|At 1, 2, 4, 6, 8 and 21-24 hours after dose on day 14.|The pharmacokinetic population was defined as all subjects who received at least 1 dose of investigational product (neratinib and/or capecitabine).|||ng*hr/mL||Standard Deviation|Mean
2715884|NCT01128842|Secondary|Progression Free Survival|Number of weeks between the date of the first dose of test article and the first date of disease recurrence or disease progression (PD), or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.|From first dose date to PD or death, up to 41 weeks.|All subjects who met Inclusion and Exclusion criteria, received at least 2 weeks of Investigational Product, and underwent at least 1 Follow Up (FU) tumor assessment at approximately cycle 2 (week 6). Subjects who died or had PD including symptomatic deterioration before the scheduled FU tumor assessment were included in the evaluable population.|||weeks||95% Confidence Interval|Median
2715885|NCT01128842|Secondary|Objective Response Rate|Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and Non Progressive Disease (PD) for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to 41 weeks.|All subjects who met Inclusion and Exclusion criteria, received at least 2 weeks of Investigational Product, and underwent at least 1 Follow Up (FU) tumor assessment at approximately cycle 2 (week 6). Subjects who died or had PD including symptomatic deterioration before the scheduled FU tumor assessment were included in the evaluable population.|||percentage of participants||95% Confidence Interval|Number
2715886|NCT01128842|Secondary|Best Overall Response|Number of participants with Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) (v1.0) criteria. CR: Disappearance of all lesions; PR: at least a 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline SLD; Progressive Disease (PD): at least a 20% increase in the SLD of target lesions, taking as reference the nadir longest diameter, meaning the smallest SLDs recorded since the treatment started, or the appearance of 1 or more new lesions, or unequivocal progression of existing nontarget lesions; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started.|From first dose date to progression or last tumor assessment, up to 41 weeks.|All subjects who met Inclusion and Exclusion criteria, received at least 2 weeks of Investigational Product, and underwent at least 1 Follow Up (FU) tumor assessment at approximately cycle 2 (week 6). Subjects who died or had PD including symptomatic deterioration before the scheduled FU tumor assessment were included in the evaluable population.|||Participants|||Count of Participants
2715959|NCT01128621|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Part A)|ECGs were taken at Screening, pre-breakfast on Day -1, on Day 1 (pre-breakfast, 1 hour, 2, 3, 4, 6, 8, 13, 24hours post-dose), and at follow-up. Assessments were made in triplicate on Day 1 at the pre-breakfast time point, and single assessments were made at all other times. ECGs were taken in supine position. The data has been presented as abnormal- not clinically significant (NCS) and abnormal-clinically significant (CS).|Up to 10 days after discharge (Day 2) in Part A|Safety Population.|||Participants|||Count of Participants
2715887|NCT01128842|Primary|Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events|DLT was defined as 1. Grade 3 or 4 non-hematologic toxicity (exceptions listed below as a.-c.), a. Grade 3 asthenia was NOT considered to be a DLT UNLESS it lasted >3 days. b. Grade 3 nausea or vomiting was NOT considered to be a DLT UNLESS the subject was already receiving optimal medical therapy. c. Grade 3 or 4 infection was NOT considered to be a DLT UNLESS it is associated with grade 3 or 4 neutropenia. 2. Grade 3 diarrhea that lasted >2 days while the subject was on optimal medical therapy or that was associated with fever (greater than or equal 38.0 ºC) or grade 3 dehydration. 3. Grade 4 neutropenia lasting ≥3 days or grade 4 febrile neutropenia. 4. Grade 4 thrombocytopenia lasting ≥3 days or complicated with bleeding or requiring platelet transfusion. 5. Delayed recovery (to National Cancer Institute [NCI] grade 1 or less, or baseline) from any of the toxicities listed above (items 1-4), that was related to study drug, and that delayed the next dose by more than 3 weeks.|From first dose date to day 21.|The safety population was defined as all subjects who received at least 1 dose of investigational product (neratinib and/or capecitabine).|||Participants|||Count of Participants
2715888|NCT01128829|Primary|The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)|we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.|Baseline||||(pmol • min •L-1)||Standard Deviation|Mean
2715889|NCT01128738|Secondary|Duration of Effect|Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of >50% production in gravimetric assessment compared to Baseline.|Up to Week 40|FAS1|||days||95% Confidence Interval|Median
2715890|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase|Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715891|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715892|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715893|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715960|NCT01128621|Primary|Number of Participants With Abnormal Vital Signs of PCI (Part B)|Assessment of vital signs (including systolic and diastolic blood pressure and heart rate) was performed at Screening, pre-breakfast on Days -1 to 14 in a fasting state early in the morning (prior to morning dosing on Days 1-14), and at Follow-up. On Days 1, 7 and 14, they were taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes.|Up to 10 days after discharge (Day 15) in Part B|Safety Population.|||Participants|||Count of Participants
2716597|NCT01123980|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of trial product(s)|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2715894|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715895|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715896|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715897|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715898|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715899|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715961|NCT01128621|Primary|Number of Participants With Abnormal Vital Signs of PCI (Part A)|Assessment of vital signs (including systolic, diastolic blood pressure and heart rate) was performed at one time point at Screening, at follow-up and pre-breakfast on Day -1. On Day 1, they were taken at pre-breakfast, 1 hour, 3, 4, 6, 10, 16 and 24 hours post-dose. Assessments were made in triplicate at the pre-breakfast time point, and single assessments were made at all other times. Assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. PCI value of systolic blood pressure: <85 and >160 millimeter of mercury (mmHg). PCI value of diastolic blood pressure: <45 and >100 mmHg. PCI value of heart rate: <40 and >110 beats per minute.|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
2715900|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715901|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715902|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715903|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715904|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715905|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715906|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715907|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715908|NCT01128738|Secondary|Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
2715909|NCT01128738|Secondary|Percentage of Responders Assessed by the HDSS in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||percentage of participants|||Number
2715910|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) * 100/mean weight at Baseline in the Second Treatment Phase.|Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase||||percent change||Standard Deviation|Mean
2715911|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS2 (LOCF dataset)|||mg||Standard Deviation|Mean
2715912|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.|||percentage of participants|||Number
2715913|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase|The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715914|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715915|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715916|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715917|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715918|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715919|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715920|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715921|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2716154|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.|Month 3 Visit|This analysis included all participants with complete data for the entire study.|||Percentage of participants|||Number
2715922|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715923|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715924|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715925|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715926|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715927|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715928|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2716006|NCT01128400|Primary|Oleic Acid Detection Level|We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids. Oleic acid taste detection thresholds were separately assessed using a three-alternative forced-choice (i.e. 3-AFC) ascending concentration.|Ranges from 5 days after screening to several weeks, pending availablity of participant.||||log10 (%W/V OLEIC ACID)||Standard Error|Mean
2715929|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715930|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715931|NCT01128738|Secondary|Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
2715932|NCT01128738|Secondary|Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||percentage of participants|||Number
2715933|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) * 100/mean weight at Baseline.|Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.|||percent change||Standard Deviation|Mean
2715934|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.|||milligrams (mg)||Standard Deviation|Mean
2715935|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Weeks 1, 8 ,12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.|||percentage of participants|||Number
2715936|NCT01128738|Primary|Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Week 4|Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.|||percentage of participants|||Number
2715937|NCT01128621|Primary|Number of Participants With Relationship Between GSK1292263 Drug Exposures and Pharmacodynamic Parameters (Part B)|Data was not collected for this outcome measure.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose|PD Population. No data was collected for this outcome measure.||||||
2715938|NCT01128621|Primary|Change From Baseline in Weighted Mean for Insulin Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline. AUC with respect to that time interval was calculated using the linear trapezoidal rule. The weighted mean was determined by dividing the AUC by the observed length of the collection interval (time of last assessment - time of first assessment in hours). In order for the AUC to be calculated, the first and last time points and at least one additional assessment falling between the two must be non-missing.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population|||pmol/L||95% Confidence Interval|Mean
2715939|NCT01128621|Primary|Change From Baseline in Weighted Mean for Glucose Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline. Weighted mean were assessed for (0-12) and (0-24). AUC with respect to that time interval was calculated using the linear trapezoidal rule. The weighted mean was determined by dividing the AUC by the observed length of the collection interval (time of last assessment - time of first assessment in hours). In order for the AUC to be calculated, the first and last time points and at least one additional assessment falling between the two must be non-missing.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||mmol/L||95% Confidence Interval|Mean
2715940|NCT01128621|Primary|Mean Post Meal Insulin Value (Part B)|Blood samples were collected on Days -1 and 14, post-breakfast at 0.5, 1, 1.5, 2 and 3 hours post dose. For lunch (approximately 4 hours post morning dose) samples were collected at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hours post morning dose), samples were taken at 0.5, 1, 1.5, 2 and 3 hours post dinner.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||pmol/L||95% Confidence Interval|Mean
2715941|NCT01128621|Primary|Mean Post Meal Glucose Value (Part B)|Blood samples were collected on Days -1 and 14, post-breakfast at 0.5, 1, 1.5, 2 and 3 hours post dose. For lunch (approximately 4 hours post morning dose) samples were collected at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hours post morning dose), samples were taken at 0.5, 1, 1.5, 2 and 3 hours post dinner.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||mmol/L||95% Confidence Interval|Mean
2715942|NCT01128621|Primary|Change From Baseline in Mean Fasted Insulin Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||pmol/L||95% Confidence Interval|Mean
2715943|NCT01128621|Primary|Change From Baseline in Mean Fasted Glucose Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||mmol/L||95% Confidence Interval|Mean
2715944|NCT01128621|Primary|Change From Baseline in Mean Fasted Insulin Value (Part A)|Baseline was considered to be Day 1 pre-breakfast. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Day 1 and 24 hours post-dose.|PD Population. Only those participants with data available at the indicated time points were analyzed.|||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2715945|NCT01128621|Primary|Change From Baseline in Mean Fasted Glucose Value (Part A)|Baseline was considered to be Day 1 pre-breakfast. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Day 1 and 24 h post-dose.|The Pharmacodynamic (PD) Population included participants from the Safety Population who had any PD parameter estimated. Only those participants with data available at the indicated time points were analyzed.|||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2715946|NCT01128621|Primary|Mean Accumulation Ratio by AUC (0-10), AUC (0-24) and Cmax for GSK1292263 (Part B)|Accumulation ratio (Ro) was derived as: Ro = Day 14 morning AUC(0-10)/Day 1 morning AUC(0-10) (for BID regimens only). Ro = Day 14 AUC(0-24)/Day 1 AUC(0-24) (for both BID and once daily regimens). Accumulation ratio (RCmax)= Day 14 Cmax/Day 1 Cmax. RCmax was not computed for each dosing period (morning and evening).|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||90% Confidence Interval|Mean
2715947|NCT01128621|Primary|T1/2 Following Repeat Dose of GSK1292263 (Part B)|"Outcome measure was added with caveat as data permits. The data for T1/2 was not collected."|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK population||||||
2716315|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2715948|NCT01128621|Primary|AUC From Time Zero (Pre-dose) to 10 Hours [AUC (0-10)] and AUC (0-24) Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. AUC (0-10) and AUC (0-24) were determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2715949|NCT01128621|Primary|Tmax and Tlag Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. Tmax was determined directly from the raw concentration-time data. Tlag was determined as the time of the sample preceding the first quantifiable concentration, on Day 1 only.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
2715950|NCT01128621|Primary|Cmax Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. Cmax was determined directly from the raw concentration-time data.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2715951|NCT01128621|Primary|Terminal Phase Half-life (t1/2) Following a Single Dose of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for t1/2 was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population||||||
2715952|NCT01128621|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) Following a Single Dose of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for AUC (0-inf) was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population||||||
2715953|NCT01128621|Primary|Volume of Distribution (V/F) (Part A)|"Outcome measure was added with caveat as data permits. The data for V/F was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population||||||
2715954|NCT01128621|Primary|Apparent Clearance Following Oral Dosing (CL/F) of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for CL/F was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|||||||
2715955|NCT01128621|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) and Time of Occurrence of Cmax (Tmax) Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of PK were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for 2 participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. Tmax was determined directly from the raw concentration-time data. Tlag was determined as the time of the sample preceding the first quantifiable concentration, on Day 1 only.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||hour||Full Range|Median
2715956|NCT01128621|Primary|Maximum Observed Concentration (Cmax) Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of PK were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. Cmax was determined directly from the raw concentration-time data.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2715957|NCT01128621|Primary|Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours [AUC (0-24)] and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-last)] Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of pharmacokinetics (PK) were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for 2 participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. AUC (0-last) and AUC (0-24) were determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|The PK Population included participants from the Safety Population who had any PK parameter estimated. Only those participants with data available at the indicated time points were analyzed.|||nanograms hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2715962|NCT01128621|Primary|Mean Value of Urine Specific Gravity (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urinalysis parameter include urine specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine . It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine .|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2715963|NCT01128621|Primary|Mean Value of Urine Specific Gravity (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urinalysis parameter include urine specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine . It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine .|Up to 10 days after discharge (Day 2) in Part A|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
2715964|NCT01128621|Primary|Mean Value of Urine pH (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urinalysis parameters included urine pH assessed using dipstick analysis. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||pH||Standard Deviation|Mean
2715965|NCT01128621|Primary|Mean Value of Urine pH (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urinalysis parameters included urine pH assessed using dipstick analysis. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral.|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||pH||Standard Deviation|Mean
2715966|NCT01128621|Primary|Mean Value of Urine Albumin (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urine albumin was assessed using quantitative analysis.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||mg/L||Standard Deviation|Mean
2715967|NCT01128621|Primary|Mean Value of Urine Albumin at Follow up (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urine albumin was assessed using quantitative analysis.|Up to 10 days after discharge (Day 2) in Part A|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||milligrams per liter (mg/L)||Standard Deviation|Mean
2715968|NCT01128621|Primary|Number of Participants With Abnormal Urinalysis Data Values (Part B)|Urinalysis parameters: Urine occult blood, Urine glucose, Urine ketones, Urine protein, White blood cells were assessed for abnormal findings by dipstick analysis. The abnormal findings were presented as trace, 1+, 2+ and 3+. Trace indicates lowest concentration of the mentioned parameters in urine and 3+ indicates highest concentration. Concentration of 3+ indicates worse outcome.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2715969|NCT01128621|Primary|Number of Participants With Abnormal Urinalysis Data Values by Dipstick Method (Part A)|Urinalysis parameters: Urine occult blood, Urine Glucose, Urine ketones and Urine protein were assessed for abnormal findings by dipstick analysis. The abnormalities were presented as trace, 1+, 2+ and 3+. Trace indicates lowest concentration of the mentioned parameters in urine and 3+ indicates highest concentration. Concentration of 3+ indicates worse outcome.|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
2715970|NCT01128621|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCI (Part B)|Blood samples for chemistry assessments were collected at screening, on Day -2 (non-fasting), and prior to breakfast (early in the morning, fasting) on Days 1, 7, and on Day 15 prior to checkout, (=24hrs post-dose), and at follow-up. Clinical chemistry parameters: Aspartate amino transferase (unit: international unit per liter [IU/L]) and Total bilirubin (unit: micromoles per liter (µmol/L) were assessed for abnormal values of PCI. For aspartate aminotransferase the PCI range was >=2 x ULN (high). For total bilirubin the PCI range was >=1.5 x ULN (high).|Up to 10 days after discharge (Day 15) in Part B|Safety Population|||Participants|||Count of Participants
2715971|NCT01128621|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCI (Part A)|"Blood samples for chemistry assessments were collected at screening, fasting (Day -1), at 24hr post- dose (morning of Day 2), and at follow-up.~Clinical chemistry parameter: Glucose (unit: millimoles per liter [mmol/L]) was assessed for abnormal high value of PCI. The normal range was 3.6 to 5.5 mmol/L"|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
2715972|NCT01128621|Primary|Number of Participants With Abnormal Hematology Values of PCI (Part B)|Blood samples for hematology assessments were collected at screening, on Day -2 (non-fasting), and prior to breakfast (early in the morning, fasting) on Days 1, 7, and on Day 15 prior to checkout, (=24hrs post-dose), and at follow-up. Hematology parameters: Hematocrit (unit: ratio) and hemoglobin (unit: grams per liter [g/L]), were assessed for abnormal values of PCI. The PCI range for hematocrit was: >0.075 decrease from Baseline (low), >1.02 x upper limit normal (ULN) (high-male), >1.17 x ULN (high-female). The PCI range for hemoglobin was: >25 decrease from Baseline (low), >1.03 x ULN (high-male), >1.13 x ULN (high-female). Data has been presented for the number of participants with hematology data values high from the PCI range in a consolidated format.|Up to 10 days after discharge (Day 15) in Part B|Safety Population|||Participants|||Count of Participants
2715973|NCT01128621|Primary|Number of Participants With Abnormal Hematology Values of Potential Clinical Importance (PCI) (Part A)|Blood samples for hematology assessments were collected at screening, fasting (Day -1), at 24hr post- dose (morning of Day 2), and at follow-up. Hematology parameter: Total Neutrophil count was assessed for abnormal value of PCI. The range of PCI value was: <0.83 x lower limit normal (LLN) with unit x10^9 per liter|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
2716007|NCT01128387|Secondary|Pathologic Response|From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information|20 weeks.|Data was not collected or analyzed for the pathologic response outcome measure.||||||
2715974|NCT01128621|Primary|Number of Participants With Any AEs and Serious Adverse Events SAEs (Part B)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to 10 days after discharge (Day 15) in Part B|Safety Population|||Participants|||Count of Participants
2715975|NCT01128621|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) (Part A)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to 10 days after discharge (Day 2) in Part A|Safety Population consisted of all participants enrolled in the study and who had received at least one dose of study drug.|||Participants|||Count of Participants
2715976|NCT01128595|Primary|EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2715977|NCT01128595|Primary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2715978|NCT01128595|Primary|LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2715979|NCT01128595|Secondary|Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 22 of each treatment period (up to Study Day 198)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||milligrams per milliliter||Standard Deviation|Mean
2715980|NCT01128595|Secondary|Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||percent change||Full Range|Median
2716598|NCT01123941|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 6-month period after vaccination||||participants|||Number
2716599|NCT01123941|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination||||participants|||Number
2715981|NCT01128595|Primary|Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population: all participants who received at least one dose of study medication, had a post-dose FEV1 assessment, and who were not major protocol violators. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2715982|NCT01128569|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.|From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)|ITT Population|||participants|||Number
2715983|NCT01128569|Secondary|Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model ANCOVA with fixed effects of treatment, period, participant-level Baseline, period level Baseline, country, sex, and age.|||Liters||Standard Error|Least Squares Mean
2715984|NCT01128569|Secondary|Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, participant-level BL, period level BL, country, sex, and age. Change from BL was calculated as the value on Day 29 minus the BL value.|||Percent change||Standard Error|Least Squares Mean
2715985|NCT01128569|Primary|Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|Intent-to-Treat (ITT) Population: par. randomized to treatment who received >=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age.|||Liters||Standard Error|Least Squares Mean
2715986|NCT01128543|Secondary|Duration of Response|Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.|From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)|All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.|||months||Inter-Quartile Range|Median
2716600|NCT01123941|Secondary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2715987|NCT01128543|Secondary|Progression-free Survival|Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.|||months||Standard Deviation|Mean
2715988|NCT01128543|Primary|Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24|Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.|Week 12 and Week 24|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.|||participants|||Number
2715989|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715990|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715991|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715992|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716023|NCT01128270|Secondary|Detectable DCA After Day 1 in Serum (0=No 1=Yes)|All four arms receive Chloral Hydrate on Day 1 (arms 1A and 1B environmental levels) and (arms 2A and 2B therapeutic levels). The question is could Dichloroacetate be detected in serum at the end of day 1. This analysis is purely descriptive, and no comparisons were planned.|1 day|All eligible session completers|||participants|||Number
2715993|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715994|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715995|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715996|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715997|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2715998|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716024|NCT01128270|Primary|Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)|The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.|5 days|all eligible participants to arm 2B (Period 4)|||micrograms per ml clorohydrate||Standard Deviation|Mean
2715999|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716000|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716001|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716002|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716003|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
2716004|NCT01128413|Primary|Lactate Clearance|The median lactate clearance from time zero to within 6 hours of the ED stay.|The median lactate clearance within 6 hours of the ED stay.|Only 9 total patients (5 Fluid Optimization; 4 Routine Care) stayed in the Emergency Department for a full 6 hours to allow calculation of a 6 hour lactate clearance. The rest of the patients left were dispositioned out of the ED before the 6 hour mark and therefore unable to calculate a 6 hour lactate clearance.|||percent lactate clearance||Inter-Quartile Range|Median
2716005|NCT01128400|Primary|Triolein Detection|We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride. Triolein taste detection thresholds were separately assessed using a three-alternative forced-choice (i.e. 3-AFC) ascending concentration.|Ranges from 5 days after screening to several weeks, pending availablity of participant.||||log10 (%W/V TRIOLEIN)||Standard Error|Mean
2716042|NCT01128192|Secondary|Change in Fasting Plasma Glucose Level|"An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at~-30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed."|-30 minutes on Day 1 and -30 minutes on Day 8||||mmol/L||Standard Deviation|Mean
2716008|NCT01128387|Primary|MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT|Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting >7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation >10 treatment days, 2) >2 interruptions of radiation per course, 3) a delay in completion of radiation by >14 days beyond planned treatment schedule, 4) inability to deliver >80% of planned treatment doses, 5) any infield grade 4 toxicity|approximately 18 weeks||||Participants|||Count of Participants
2716009|NCT01128361|Primary|Cornell Scale for Depression in Dementia|The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.|Week 0, 13, and 26|Linear mixed models were used with all available data. Overall numbers analyzed may not reflect numbers at each timepoint|||units on a scale||Standard Deviation|Mean
2716010|NCT01128361|Primary|Disability Assessment for Dementia|This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.|Week 0, 13, and 26|Linear mixed models were used with all available data. Overall number of participants may not match numbers at each timepoint.|||percentage on a scale||Standard Deviation|Mean
2716011|NCT01128361|Primary|Executive Function Composite|"A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged.~Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores."|Week 0, 13, and 26|Linear mixed models were used with all available data included. Overall numbers analyzed do not necessarily match the outcome measure at each timepoint|||standardized units on a scale||Standard Deviation|Mean
2716012|NCT01128361|Primary|Memory Composite|"A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged.~Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores."|week 0, 13, and 26|Linear mixed models with all available data were used. Thus the overall number of participants analyzed does not necessarily match the means reported at each timepoint.|||units on a standardized scale||Standard Deviation|Mean
2716013|NCT01128296|Secondary|Overall Survival (OS) by p53 Mutant Status||Up to 35 months|Participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
2716014|NCT01128296|Secondary|Disease-free Survival by p53 Genetic Status||Up to 35 months|Participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
2716015|NCT01128296|Secondary|Overall Survival (OS) by CA 19-9 Response|Median number of months of overall survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or, no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%.|Up to 35 months|Analysis population included participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response|||months||95% Confidence Interval|Median
2716016|NCT01128296|Secondary|Disease-free Survival (DFS) by CA 19-9 Response|Median number of months of disease-free survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%.|Up to 30 months|Analysis population included a total of 26 participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response.|||months||95% Confidence Interval|Median
2716017|NCT01128296|Secondary|R0 Resection Rate|Number of participants that underwent a resection with microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed (24) / number of that completed treatment (31)|Up to 30 months|Participants that completed more than 80 % of the intended dose of HCQ.|||percentage of participants|||Number
2716018|NCT01128296|Secondary|Overall Survival (OS) by Response to HCQ Treatment|Median number of months of overall survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ.|Up to 35 months|Subset of participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
2716019|NCT01128296|Secondary|Disease-free Survival (DFS) by Response to HCQ Treatment|Median number of months of disease-free survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ.|Up to 30 months|Subset of participants that completed more than 80% of the intended dose of HCQ treatment.|||months||95% Confidence Interval|Median
2716020|NCT01128296|Secondary|Overall Survival (OS)|Median number of months of overall survival for participants receiving study treatment.|Up to 35 months|Participants that completed more than 80% of the intended dose of HCQ.|||months||95% Confidence Interval|Median
2716021|NCT01128296|Secondary|Disease-free Survival (DFS)|Median number of months of disease-free survival for participants receiving study treatment.|Up to 30 months|Participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
2716022|NCT01128296|Primary|Number of Participants That Experienced a Dose Limiting Toxicity (DLT)|Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT).|Up to 31 days|Observed for dose-limiting toxicities or treatment delays attributed to HCQ to determine the maximum tolerated dose.|||participants|||Number
2716025|NCT01128270|Primary|Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate|Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.|5 days|This applies only to Arm 2B (Therapeutic Chloral Hydrate without DCA.|||minutes||Standard Deviation|Mean
2716026|NCT01128270|Primary|Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.|After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.|6 Days||||micrograms/ml||Standard Deviation|Mean
2716027|NCT01128244|Secondary|Plasma 3-hydroxykynurenine Concentration|For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation.|April, 2010 - June, 2014|Women using oral contraceptives and exhibiting low vitamin B6 status.|||microl/L||Standard Deviation|Mean
2716028|NCT01128244|Primary|Fasting Plasma Cystathionine Concentration|For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.|||micromol/L||Standard Deviation|Mean
2716029|NCT01128244|Primary|Fasting Plasma Pyridoxal Phosphate Concentration|For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.|||nmol/L||Standard Deviation|Mean
2716030|NCT01128244|Primary|Flux of Homocysteine Remethylation From Serine-derived Carbon|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives and exhibiting low vitamin B6 status.|||micromol/(kg x hr)||Standard Deviation|Mean
2716031|NCT01128244|Primary|Total Remethylation of Homocysteine|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives exhibiting low vitamin B6 status evaluated at baseline and after vitamin B6 supplementation.|||micromol/(kg x hr)||Standard Deviation|Mean
2716032|NCT01128192|Primary|Change in High-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10||||mg/kg/min||Standard Deviation|Mean
2716033|NCT01128192|Primary|Change in Low-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10||||mg/kg/min||Standard Deviation|Mean
2716034|NCT01128192|Primary|Change in High Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10||||percentage of EGP inhibition||Standard Deviation|Mean
2716035|NCT01128192|Primary|Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10||||percentage of EGP Inhibition||Standard Deviation|Mean
2716036|NCT01128192|Primary|Change in Basal Endogenous Glucose Production (EGP)|Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10||||mg/kg/min||Standard Deviation|Mean
2716037|NCT01128192|Primary|Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp|Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.|0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)||||h*pmol/L||Standard Deviation|Mean
2716038|NCT01128192|Primary|Change in Insulin Basal Level|Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)|-30 min and -15 min on Day 2 and Day 9||||pmol/L||Standard Deviation|Mean
2716039|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)||||h*pmol/L||Standard Deviation|Mean
2716040|NCT01128192|Secondary|Change Fasting Plasma Insulin Level|An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.|-30 minutes on Day 1 and -30 minutes on Day 8||||pmol/L||Standard Deviation|Mean
2716041|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)||||h*mmol/L||Standard Deviation|Mean
2716043|NCT01128179|Secondary|Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)||12 weeks|PP|||mmol^2/L^2||Standard Error|Least Squares Mean
2716049|NCT01128179|Primary|Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)|FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.|12 Weeks|Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.|||pg/ml||Standard Error|Least Squares Mean
2716050|NCT01128153|Secondary|Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)|Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||Participants|||Number
2716051|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mmol/L||95% Confidence Interval|Mean
2716052|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mg/dL||95% Confidence Interval|Mean
2716053|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mmol/L||95% Confidence Interval|Mean
2716054|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mg/dL||95% Confidence Interval|Mean
2716055|NCT01128153|Primary|Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)|Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24 weeks|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||percent||95% Confidence Interval|Mean
2716056|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score|"The CGI-S is scored to rate patient's current clinical state. At enrolment patient's condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is Normal, not at all ill and a score of 7 indicates that a patient is Among the most extremely ill patients."|Baseline, week 4|||||||
2716057|NCT01128114|Secondary|The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4|"The Global Improvement scale (CGI-I) is scored to rate the patient's change from baseline CGI. A CGI-I score of 1 indicates that a patient is very much improved and a score of 7 indicates that a patient is very much worse. CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating ≤ 2 at Day 29"|Baseline, week 4|||||||
2716058|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score|The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.|Baseline, week 4|||||||
2716059|NCT01128114|Primary|The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)|CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.|Baseline, week 4|As the study was terminated prematurely none of the randomized patients have been analysed.|||Participants|||Number
2716060|NCT01128049|Primary|Visual Quality|Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.|5 seconds|The comparison was between normal, non-dry eye participants and dry eye groups.|||microns||Standard Deviation|Mean
2716061|NCT01127763|Primary|Toxicity Profile-Non Hematological|Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.|||percentage of patients|||Number
2716062|NCT01127763|Secondary|Median Progression-free Survival Time|Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 1 year|Any patient with at least one dose of treatment.|||months||95% Confidence Interval|Median
2716063|NCT01127763|Primary|Toxicity Profile-Hematological|Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.|||percentage of patients|||Number
2716064|NCT01127763|Primary|Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)|Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 1 year|Any patient with at least one dose of treatment.|||percentage of patients||95% Confidence Interval|Number
2716065|NCT01127737|Primary|Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention|The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.|1 month|Per protocol|||Participants|||Number
2716066|NCT01127659|Secondary|Inflammation||6 months|||||||
2716067|NCT01127659|Secondary|Body Composition||6 months|||||||
2716068|NCT01127659|Primary|Insulin Sensitivity|measured by HE clamps (baseline and 6 mths)|6 months|Glucose infusion rate in HE clamps was measured|||mg/kg fat free mass/min||Standard Deviation|Mean
2716069|NCT01127646|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
2716070|NCT01127646|Other Pre-specified|Change From Baseline in Heart Rate up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2716071|NCT01127646|Secondary|Global Impression of Perceived Difficulties Investigator Version (GIPD-Inv) Total Score and Subscores At Weeks 2, 3, and 4|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, and over entire day and night). Difficulties during past week are rated by investigator on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716072|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score During the 4-Week Treatment Period|The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conners' Global Index-Teacher Rating Scale total score for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716073|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Total Score and Subscores During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 3 common morning behaviors (such as, get out of bed) and 8 common evening behaviors (such as, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. Mean DPREMB-R total score and subscores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716074|NCT01127646|Secondary|Patient Outcomes Questions (On-Days Versus Off-Days) During the 4-Week Treatment Period|"6-item questionnaire from attention-deficit/hyperactivity disorder (ADHD) advocacy group evaluates treatment outcomes ADHD participant's perspective. Parent completed on each day of on/off period. Each item ranged from 1 (I totally agree) to 5 (I totally disagree). Items 1 and 2 pertain to sleeping and eating; high scores=better outcome. Items 3-6 pertain to behavior; high scores=worse outcome. The mean scores for analysis would have been created for each question across the days of each of the on and off phases; however, mean scores were not analyzed due to insufficient sample size."|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716075|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Subscores (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R subscores between days without missing doses (on-days) and days with missing doses (off-days) not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716076|NCT01127646|Secondary|Emotion Expression Scale for Children (EESC)-Parent Rated Total Score up to Week 5|"29-item parent-reported measure used to monitor effect of attention-deficit/hyperactivity disorder (ADHD) medication; examines 3 aspects of emotion expression: positive emotions, emotional flatness, and emotional lability. Each item rated on 5-point Likert scale (1=not at all true to 5=very much true). Positive emotional subscale items reversed scored (6-raw score). Total score=transformed positive emotion + emotional flatness+ emotional lability subscales. Total scores range: 29 to 145. Higher scores=emotional impairment. This outcome measure not analyzed due to insufficient sample size."|Up to Week 5|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716077|NCT01127646|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) at Weeks 2, 3, and 4|This instrument is a single-item expert rating of the severity of the participant's attention-deficit/hyperactivity disorder (ADHD) symptoms in relation to the assessor's total experience of participants with ADHD. Severity is rated on a 7-point scale (1=normal, not ill at all; 7=among the most extremely ill participants). Higher scores represent greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716078|NCT01127646|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator Administered and Scored (ADHD-RS-IV Parent:Inv) Total Score and Subscores at Weeks 2, 3, and 4|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716079|NCT01127646|Secondary|Global Impression of Perceived Difficulties Scale-Patient Version (GIPD-Pat) Scale Total Score and Individual Items During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Difficulties during past week are rated by participant on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. Mean GIPD-Pat total score and individual item scores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716080|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conner's Global Index-Teacher Rating Scale total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716081|NCT01127646|Secondary|Global Impression of Perceived Difficulties (GIPD) Scale-Patient Version Total Score and Individual Items (On-Days Versus Off-Days) During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Participant rates difficulties during past week on 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. GIPD-Pat total score and item scores between days without missing doses (on-days) and days with missing doses (off-days) were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716082|NCT01127646|Primary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
2716083|NCT01127633|Secondary|Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease|Florbetapir PET imaging was used to test for change from baseline. The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants with mild Alzheimer's Disease from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for Amyloid Plaque Burden.|||Standard Uptake Value ratio (SUVr)||Standard Deviation|Mean
2716110|NCT01127607|Secondary|Disruptive Behavior Disorder Rating Scale (DBD)|measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716084|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADAS-Cog11.|||units on a scale||Standard Error|Least Squares Mean
2716085|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)|The vMRI assessment of right and left hippocampal volume is reported. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for vMRI.|||Cubic millimeter (mm³)||Standard Error|Least Squares Mean
2716086|NCT01127633|Secondary|Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels|Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 52|All Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for plasma Aβ 1-40 and Aβ 1-42.|||picograms per milliliter (pg/mL)||Standard Error|Least Squares Mean
2716087|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)|The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for MMSE.|||Units on a scale||Standard Error|Least Squares Mean
2716088|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)|The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for QoL-AD.|||Units on a scale||Standard Error|Least Squares Mean
2716089|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)|EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for EQ-5D Proxy.|||Units on a scale||Standard Error|Least Squares Mean
2716090|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours|The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for RUD-Lite.|||hours per day (hr/day)||Standard Error|Least Squares Mean
2716091|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)|The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for NPI.|||Units on a scale||Standard Error|Least Squares Mean
2716092|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for CDR-SB.|||Units on a scale||Standard Error|Least Squares Mean
2716093|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADCS-ADL.|||Units on a scale||Standard Error|Least Squares Mean
2716094|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADAS-Cog14.|||Units on a scale||Standard Error|Least Squares Mean
2716095|NCT01127633|Primary|Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)|The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 104|All randomized participants who received at least one dose of study drug.|||participants|||Number
2716096|NCT01127607|Secondary|Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase|Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.|baseline and end of med optimization phase/week 4|Uses a within-subjects design; the same 27 participants are in both arms.|||scores on a scale||Standard Deviation|Mean
2716097|NCT01127607|Secondary|Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More|Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).|end of medication optimization phase/week 4|Within-subjects analysis; data entered per dose not per subject. For example, if subject 1 took 30mg, 50mg and 70mgdoses during titration, they are recorded as three separate entries. Sample size reduces as dose increases because participants stopped at lowest acceptable dose and only moved to higher dose if they did not meet optimization criteria.|||Percent of participants|||Number
2716151|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed since their previous visit.|Month 6 Visit|All participants with evaluable case report forms were analyzed.|||participants|||Number
2716099|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.|||Percentage of behaviors||Standard Deviation|Mean
2716100|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.|||behaviors||Standard Deviation|Mean
2716101|NCT01127607|Secondary|Weight|Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).|study endpoint- end of period II (between subjects trial)||||kg||Standard Deviation|Mean
2716102|NCT01127607|Secondary|Impairment Rating Scale (IRS)|self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716103|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (never) to 5 (always). Items summed into composite scales.~At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716104|NCT01127607|Secondary|Resting Blood Pressure|Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)||||mm Hg||Standard Deviation|Mean
2716105|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale Mean Severity Rating.|rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716106|NCT01127607|Secondary|Barkley Home Situations Questionnaire (HSQ)|Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)||||number of child problems endorsed||Standard Deviation|Mean
2716107|NCT01127607|Secondary|ADHD Severity Clinical Global Impressions Severity Subscale|clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716108|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716109|NCT01127607|Secondary|Impairment Rating Scale (IRS)|measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716111|NCT01127607|Secondary|Social Skills Rating System (SSRS)|"Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 (never) to 2 (often).At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior)."|study endpoint- end of period II (between subjects trial)||||standard scores||Standard Deviation|Mean
2716112|NCT01127607|Secondary|Brown Attention Deficit Scale (BAADS)|"Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 (never) to 3 (almost daily). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)||||t score||Standard Deviation|Mean
2716113|NCT01127607|Secondary|Parenting Locus of Control (PLC)|"self completed parenting measure of the degree to which parents feel they can influence their child's behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 (strongly disagree) to 5 (strongly agree). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716114|NCT01127607|Secondary|Parenting Stress Index (PSI)--Total Stress|measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716115|NCT01127607|Secondary|Adult ADHD Rating Scale (ADHD RS)|measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
2716116|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale|rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.|baseline and end of dose optimization phase/week 4|Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms.|||units on a scale||Standard Deviation|Mean
2716117|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design; the same 26 participants completed all arms.|||Percentage of behaviors||Standard Deviation|Mean
2716118|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS)|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design for this phase; the same 26 participants completed all four arms.|||behaviors||Standard Deviation|Mean
2716119|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.|baseline and week 4|Uses a within-subjects design; the same 25 participants are in both arms.|||units on a 0 to 10 scale||Standard Deviation|Mean
2716152|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 3 Visit|This analysis included all participants with complete data for the entire study.|||Participants|||Number
2716120|NCT01127607|Secondary|Impairment Rating Scale (IRS)|"Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by no problems / no need for treatment and at the high end by extreme problem / definitely needs treatment. Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Uses a within-subjects evaluation; the same 25 participants are in both arms.|||units on a 0 to 6 scale||Standard Deviation|Mean
2716121|NCT01127607|Secondary|Disruptive Behavior Disorders Rating Scale (DBD)|Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.|baseline and week 4|Used a within-subjects design; the same 24 participants measured in both arms.|||units on a scale||Standard Deviation|Mean
2716122|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (never) to 5 (always). Items summed into composite scales.~Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Used a within-subjects evaluation; the same 24 participants evaluated in both arms.|||units on a scale||Standard Deviation|Mean
2716123|NCT01127581|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.|From study drug administration to hospital discharge (approximately 48-72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.|||percentage of participants|||Number
2716124|NCT01127581|Secondary|Incidence of Vaginal Delivery||Interval from study drug administration to vaginal delivery (average 24 hours)|The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
2716125|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 24 Hours||Interval from study drug administration to vaginal delivery within 24 hours|Intention-to-Treat (ITT) Population|||percentage of participants||95% Confidence Interval|Number
2716126|NCT01127581|Secondary|Incidence of Any Delivery Within 12 Hours||Interval from study drug administration to delivery of neonate within 12 hours|Intention-to-Treat (ITT) Population|||percentage of participants||95% Confidence Interval|Number
2716127|NCT01127581|Secondary|Incidence of Any Delivery Within 24 Hours||Interval from study drug administration to delivery of neonate within 24 hours|Intention-to-Treat (ITT) Population|||percentage of participants||95% Confidence Interval|Number
2716128|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 12 Hours||Interval from study drug administration to vaginal delivery within 12 hours|Intention-to-Treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2716129|NCT01127581|Secondary|Incidence of Pre-delivery Oxytocin During the First Hospital Admission|Percentage of participants in receipt of Oxytocin for induction after study drug removal.|At least 30 minutes after study drug removal|Analysis population includes subjects who delivered during the first hospitalization.|||percentage of participants||95% Confidence Interval|Number
2716130|NCT01127581|Secondary|Time to Active Labor During the First Hospital Admission|Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.|Interval from study drug administration to active labor (average 12 hours)|Intention-to-Treat (ITT) population|||minutes||95% Confidence Interval|Median
2716131|NCT01127581|Secondary|Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission||Interval from study drug administration to neonate delivery (average 24 hours)|Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.|||minutes||95% Confidence Interval|Median
2716132|NCT01127581|Primary|Incidence of Cesarean Delivery During the First Hospital Admission||Interval from study drug administration to cesarean delivery (average 24 hours)|Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.|||percentage of participants||95% Confidence Interval|Number
2716133|NCT01127581|Primary|Time to Vaginal Delivery During the First Hospital Admission||Interval from study drug administration to vaginal delivery (average 24 hours)|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.|||minutes||95% Confidence Interval|Median
2716134|NCT01127503|Secondary|To Evaluate the Efficacy of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS||13 weeks|The study was terminated early and no data was collected||||||
2716135|NCT01127503|Primary|To Evaluate the Safety of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS||13 weeks|The study was terminated early and no data was collected||||||
2716136|NCT01127438|Secondary|Number of Participants With Modified Sedation Success|Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.|Day 1|Full Analysis Population.|||Participants|||Number
2716137|NCT01127438|Secondary|Number of Participants With Treatment Success|Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.|Day 1|Full Analysis Population.|||Participants|||Number
2716138|NCT01127438|Primary|Number of Participants With Sedation Success|Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.|Day 1|Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement.|||Participants|||Number
2716139|NCT01127321|Secondary|Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit||Predose on Day 1; Day 85, 113, and 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.|||participants|||Number
2716140|NCT01127321|Secondary|Pharmacokinetic Parameters for MEDI-570|Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169|Due to early termination of the study, the results were reported as individual participant’s listings but not statistically summarized.||||||
2716141|NCT01127321|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to Day 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.|||participants|||Number
2716142|NCT01127256|Secondary|Quality of Life in Epilepsy (QoL-QOLIE31)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|24 weeks||||Units On a Scale||Standard Deviation|Mean
2716143|NCT01127256|Secondary|The Percentage of Participants With Retention Rate|The percentage of participants who completed the trial.|24 weeks||||percentage of participants|||Number
2716144|NCT01127256|Primary|The Percentage of Participants With Seizure Free Rate|The percentage of participants who had no seizure during the trial.|24 weeks||||percentage of participants|||Number
2716145|NCT01127165|Secondary|Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)|The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.|Baseline and 24 weeks||||Scores on a Scale||Standard Deviation|Mean
2716146|NCT01127165|Secondary|Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)|The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children's behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.|Baseline and 24 weeks||||Scores on a Scale||Standard Deviation|Mean
2716147|NCT01127165|Secondary|Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)|Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.|Baseline and 24 weeks||||Scores on a Scale||Standard Deviation|Mean
2716148|NCT01127165|Primary|Percentage of Participants Who Were Assessed As Seizure Free|The percentage of participants who showed no seizure during the maintenance phase.|24 weeks||||percentage of participants|||Number
2716149|NCT01127139|Secondary|Adverse Events Leading to Study Discontinuation|The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.|Baseline to Month 6 Visit|All participants with case report forms were included in this analysis.|||Participants|||Number
2716150|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 6 Visit|This analysis included all participants with complete data for the entire study.|||Participants|||Number
2716155|NCT01127139|Secondary|Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.|Baseline to Month 6 Visit|This analysis included all participants with complete data for the entire study.|||mmHg||Standard Deviation|Mean
2716156|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed after three months of treatment.|Month 3 Visit|All participants with evaluable case report forms were analyzed.|||participants|||Number
2716157|NCT01127087|Secondary|Total Urinary Oxalate Excretion|Oxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.|Baseline, 4 weeks||||mg/24 hrs||Standard Deviation|Mean
2716158|NCT01127087|Primary|Urinary Oxalate Creatinine Ratio|The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.|Baseline, Week 4||||mg/g||Standard Deviation|Mean
2716159|NCT01127061|Other Pre-specified|Change in Left Atrial Volume Index|Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left atrial volume index was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms.|At study enrollment and 4 months later|These numbers reflect the attrition rates in the study as well as ability to accurately obtain the data given image quality.|||mL/m2||95% Confidence Interval|Mean
2716160|NCT01127061|Other Pre-specified|Change in Left Atrial Size|Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left atrial size was measured by echocardiography at study enrollment and termination (4 months later) and change over time was compared between study arms.|At study enrollment and 4 months later|These numbers reflect the attrition rates in the study as well as ability to accurately obtain the data given image quality.|||mm||95% Confidence Interval|Mean
2716161|NCT01127061|Other Pre-specified|Change in Left Ventricular End Systolic Volume Index|Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular end systolic index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.|At study enrollment and 4 months later|These numbers reflect number of participants who were able to undergo cardiac MRI and attrition rates in the study.|||mL/m2||95% Confidence Interval|Mean
2716162|NCT01127061|Other Pre-specified|Change in Left Ventricular End Diastolic Volume Index|Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular end diastolic volume index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.|At study enrollment and 4 months later|These numbers reflect the number of participants who were able to undergo cardiac MRI and attrition rates in the study.|||mL/m2||95% Confidence Interval|Mean
2716163|NCT01127061|Other Pre-specified|Change in Left Ventricular Mass Index|Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Left ventricular mass index was measured by cardiac MRI at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.|At study enrollment and 4 months later|These numbers reflect the number of participants who were able to undergo cardiac MRI and attrition rates in the study.|||g/m2||95% Confidence Interval|Mean
2716164|NCT01127061|Other Pre-specified|Change in Diastolic Function|Diastolic function was assessed at each time point and categorized as indeterminate diastolic function, grade I diastolic dysfunction and grade II-III diastolic dysfunction, according to American Society of Echocardiography criteria. Number of participants whose findings fell into each category was calculated and % change over time was compared between study arms. Indeterminate indicates diastolic function could not be accurately categorized. Grade I diastolic dysfunction indicates least severe in terms of outcome measure and Grade III, most severe.|At study Enrollment and 4 months later|These numbers reflect attrition rates in the study, as well as, whether data was reliably obtained at each time point.|||% of participants||95% Confidence Interval|Mean
2716165|NCT01127061|Other Pre-specified|Change in Maximal Left Ventricle Wall Thickness|Magnitude or distribution of cardiac hypertrophy or left ventricular dimensions were a pre-specified outcome. Maximal left ventricle (LV) wall thickness (mm) was measured by cardiac MRI performed at study enrollment and termination (4 months later) and change over time was compared between study arms. Cardiac MRI was only be performed in those who do not have implantable devices or claustrophobia significant enough to require sedation.|At study enrollment and 4 months later|These numbers reflect the number of participants that underwent cardiac MRI and attrition rates in the study.|||mm||95% Confidence Interval|Mean
2716166|NCT01127061|Other Pre-specified|Change in Degree of Left Ventricular Outflow (LVOT) Obstruction.|Cardiopulmonary exercise testing in combination with echocardiography was performed at study enrollment and termination (4 months). Peak left ventricular outflow gradients were obtained at rest, with Valsalva and after exercise at each time point. The change over time was compared by study arm assignment.|At study enrollment and 4 months later|These numbers reflect the rate of attrition in the study, as well as, whether data was reliably obtained at each time point.|||mm Hg||95% Confidence Interval|Mean
2716167|NCT01127061|Other Pre-specified|Change in Systolic Function as Measured by Left Ventricular Ejection Fraction.|Echocardiography was performed at study enrollment and termination. Left ventricular ejection fraction was visually estimated on each echocardiogram. Change over time was compared by study arm assignment.|At study enrollment and 4 months later|These numbers reflect attrition rates in the study, as well as, whether data was reliably obtained at each time point.|||percentage of ventricular blood||95% Confidence Interval|Mean
2716241|NCT01126541|Secondary|Cortisone Intake AUC (Time- and Weight-Weighted)|All cortisone intakes (in mg) were taken into account (oral, IV [including the cortisone administration before the rituximab infusion], intramuscular, and intra-articular).|Day 1 (each infusion), Week 24, Week 104|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg*week||Standard Error|Mean
2716168|NCT01127061|Other Pre-specified|Change in Scar Volume|Cardiac MRI was performed in all patients without implantable devices/claustrophobia requiring sedation at study enrollment and termination (4 months later). Scar volume was calculated as total delayed gadolinium enhancement mass at each time interval. Change over time was compared between study arms.|At study enrollment and 4 months later|These numbers reflect attrition rates in the study, as well as, whether cardiac MRI was performed.|||g||95% Confidence Interval|Mean
2716169|NCT01127061|Other Pre-specified|Change in Concentration of Brain Natriuretic Peptide (BNP)|Blood will be drawn to evaluate BNP at study enrollment and termination (4 months later). Change over time was compared between study arms.|At study enrollment and 4 months later|These numbers reflect attrition rates in the study, as well as, whether data was obtained at each time point.|||pg/mL||Inter-Quartile Range|Median
2716170|NCT01127061|Other Pre-specified|Change in Quality of Life|"Quality of life (QOL) questionnaires (Minnesota Living With Heart Failure Questionnaire, MLHF; Quick Inventory of Depressive Symptomatology-Self Report, QIDS-SR16; and the 36-Item Short-Form Health Survey Version 2, SF-36v2) were administered at study enrollment and termination (4 months later). Change over time was compared between study arms.~MLHF: range, 0-105; higher scores indicate worse QOL QIDS-SR16: range, 0-27; higher scores indicate more severe depression SF-36v2: 8 subscales and 2 component summary scores; range, 1-100; lower scores indicate more disability; minimal clinically important difference, 3 to 5 points"|At study enrollment and 4 months later|These numbers reflect attrition rates in the study.|||units on a scale||95% Confidence Interval|Mean
2716171|NCT01127061|Primary|Change in Peak Oxygen Consumption (Peak VO2)|Cardiopulmonary exercise testing was performed at study enrollment and termination (4 months apart). Peak VO2 was measured at each time point in each subject and change in peak VO2 over time was calculated. The change in Peak VO2 was compared between the study arms.|At study Enrollment and 4 months later|These numbers reflect the attrition rates seen in the study.|||mL/kg/min||95% Confidence Interval|Mean
2716172|NCT01126957|Secondary|Satisfaction With Procedural Sedation|Score of 1 to 5 with 5 being completely satisfied and 1 being not satisfied at all was recorded by both the monitoring nurse and the physician performing the procedural sedation|20 minutes|103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.||||||
2716173|NCT01126957|Primary|Respiratory Depression|"Endotracheal carbon dioxide (ETCO2) rise > 5mm/hg~Arterial oxygen saturation (SaO2) <90%~Respiratory rate (RR) < 8 br/min~Apnea > 15 sec~airway manipulation"|Baseline and throughout procedure|103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.||||||
2716174|NCT01126879|Secondary|Measurement of PSA in Serum and Plasma by Nanotechnology|Blood will be collected to measure PSA in serum and plasma by nanotechnology at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.|At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery|Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.||||||
2716175|NCT01126879|Secondary|Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue|At baseline and time of surgery, tissue will be collected to measure the effect of genistein on select gene and protein expressions in prostate tissue.|At baseline and at time of surgery|Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.||||||
2716176|NCT01126879|Secondary|Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy|Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery.|At baseline, 1 and 12 months after surgery|Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.||||||
2716177|NCT01126879|Primary|Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs|Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.|At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery|Data was not collected for analysis of this endpoint due to the study closing before the accrual goal was met.||||||
2716178|NCT01126801|Secondary|Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.||||||
2716179|NCT01126801|Primary|Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.||||||
2716180|NCT01126723|Primary|Frailty Index|Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.|post-intervention|per protocol|||participants|||Number
2716181|NCT01126671|Secondary|Assessment of Bone Markers at Follow-up|After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.|12 weeks||||ug/L||Standard Deviation|Mean
2716182|NCT01126671|Secondary|Baseline Assessment of Bone Markers|Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation|Baseline||||ng/ml||Standard Deviation|Mean
2716183|NCT01126671|Primary|Follow-up 25OHD Levels|After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.|12 weeks||||ng/ml||Standard Deviation|Mean
2716184|NCT01126671|Primary|Baseline 25 Hydroxy Vitamin D (25OHD) Levels|25OHD will be drawn at baseline prior to starting vitamin D supplementation.|Baseline||||ng/ml||Standard Deviation|Mean
2716295|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716185|NCT01126619|Secondary|Number of Participants With Adverse Events (AEs)|"The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.~Please see the Adverse Event module below for additional details."|24 Weeks|All enrolled participants.|||participants|||Number
2716186|NCT01126619|Secondary|Percent Change From Baseline in Work Productivity and Activity Impairment|"The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):~Percent work time missed in the last 7 days due to problems associated with psoriasis;~Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;~Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;~Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.~Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30).|||percent change||Full Range|Mean
2716187|NCT01126619|Primary|Percentage of Participants With 75% Reduction in PASI Score|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||percentage of participants|||Number
2716188|NCT01126619|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.~Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||percent change||Full Range|Mean
2716189|NCT01126619|Secondary|Static Physician Global Assessment (PGA) of Psoriasis|"In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:~Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||participants|||Number
2716190|NCT01126619|Secondary|Dynamic Patient Global Assessment (PGA) of Change in Psoriasis|In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||scores on a scale||Standard Deviation|Mean
2716191|NCT01126619|Secondary|Dynamic Physician Global Assessment (PGA) of Change in Psoriasis|In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from -5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||scores on a scale||Standard Deviation|Mean
2716192|NCT01126619|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||Percent change||Standard Deviation|Mean
2716193|NCT01126593|Primary|Pain Scores|Pain was measured via Visual Analong Scale in measurement (0-100mm).|O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.||||mm||Standard Deviation|Mean
2716194|NCT01126580|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2716316|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716195|NCT01126580|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin.|||participants|||Number
2716196|NCT01126580|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.|||participants|||Number
2716197|NCT01126580|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
2716198|NCT01126580|Secondary|Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.|||events|||Number
2716199|NCT01126580|Secondary|Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
2716200|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||picograms per milliliter (pcg/mL)||Inter-Quartile Range|Median
2716201|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter (U/L)||Inter-Quartile Range|Median
2716202|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides|Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable triglyceride data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||percentage change in triglycerides||Inter-Quartile Range|Median
2716203|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)|Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable LDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||percentage change in LDL-C||Inter-Quartile Range|Median
2716204|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)|Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||percentage change in HDL-C||Inter-Quartile Range|Median
2716317|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716205|NCT01126580|Secondary|Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol|Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable cholesterol data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage change in total cholesterol||Inter-Quartile Range|Median
2716206|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable blood pressure data.|||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
2716207|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2716208|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2716209|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG QTcF interval or PR interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
2716210|NCT01126580|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin.|||participants|||Number
2716211|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score|"The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score."|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DSC-r data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2716212|NCT01126580|Secondary|Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQc data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2716220|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable fasting blood glucose data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2716213|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2716214|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2716215|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score."|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2716216|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
2716217|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable BMI data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
2716218|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
2716219|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable SMBG data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2716906|NCT01121913|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
2716221|NCT01126580|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2716222|NCT01126580|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2716223|NCT01126580|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2716224|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Pain in Participants With MCII|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716225|NCT01126541|Secondary|Percentage of Participants With MCII in Pain|Participants were asked how their pain had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse pain.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2716226|NCT01126541|Secondary|Patient Global Assessment of Pain in Participants Reporting Acceptable Symptoms Using PASS|"Patient Global Assessment of Pain assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. Higher values correspond to worst state of participant (high pain levels)."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716227|NCT01126541|Secondary|Percentage of Participants With Acceptable Symptom State in Pain Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
2716228|NCT01126541|Secondary|Change From Baseline in HAQ-DI in Participants With MCII|HAQ-DI was assessed in participants with MCII. HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716229|NCT01126541|Secondary|Percentage of Participants With MCII in Functioning|Participants were asked how their functioning had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
2716239|NCT01126541|Secondary|HAQ-DI Scores|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716230|NCT01126541|Secondary|HAQ-DI Scores in Participants Reporting Acceptable Function Using PASS|HAQ-DI was assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours). HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716231|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Symptom State in Functioning Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of function they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of function they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
2716232|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity in Participants With MCII|"The Patient's Global Assessment of Disease Activity was assessed in participants reporting MCII on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity)."|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716233|NCT01126541|Secondary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) in Disease Activity|Participants were asked how their disease activity had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more disease activity.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
2716234|NCT01126541|Secondary|Patient Global Assessment of Disease Activity in Participants Reporting Acceptable Symptoms Using PASS|"The Patient's Global Assessment of Disease Activity assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity)."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716235|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Disease Activity Symptom State Assessed Using Patient Acceptable and Unacceptable Symptom State (PASS)|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of disease activity they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
2716236|NCT01126541|Secondary|Medical Outcomes Study Sleep Scale (MOS-Sleep) Composite Sleep Problems 6 (SLP6) Index|The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The SLP6 index is comprised of 6 items: provides a summary of sleep problems and contains questions from the sleep disturbance, sleep adequacy, respiratory impairment, and somnolence domains. The SLP6 index score ranges between 0 and 100, with higher values corresponding to more sleep problems.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population;n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716237|NCT01126541|Secondary|SF-12 Mental Health Composite Score|Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716238|NCT01126541|Secondary|Short Form 12 (SF-12) Physical Health Composite Score|Physical and Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716240|NCT01126541|Secondary|Total Mean Dose of Cortisone Between Week 24 and Week 104|All cortisone intakes were taken into account, including oral, IV (including the cortisone administration before the rituximab infusion), intramuscular and intra-articular.|Week 24 to Week 104|ITT population|||mg||Standard Deviation|Mean
2716242|NCT01126541|Secondary|Participant Assessment of Fatigue|"Participants were asked to rate their level of fatigue over the last 7 days on a 100-mm VAS. The left-hand extreme of the line equals 0 mm, and is described as no fatigue and the right-hand extreme equals 100 mm as extreme fatigue. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high levels of fatigue)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716243|NCT01126541|Secondary|Patient's Global Assessment of Pain|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716244|NCT01126541|Secondary|Patient Global Assessment of Disease Activity|"The Patient's Global Assessment of Disease Activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716245|NCT01126541|Secondary|Physician's Global Assessment of Disease Activity|"The Physician's Global Assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). Physicians were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high disease activity)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2716246|NCT01126541|Secondary|Percentage of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at 24 Weeks After Treatment|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2716247|NCT01126541|Secondary|Percentage of Participants With Rheumatoid Factor (RF) at 24 Weeks After Treatment|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 international units per milliliter (IU/mL) is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2716248|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Retreatment by EULAR Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Week 24, 24 weeks after 1st retreatment, 24 weeks after 2nd retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2716249|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Initial Treatment by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Day 15, Weeks 6, 12, and 24|Overall population|||percentage of participants|||Number
2716250|NCT01126541|Secondary|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, and 70% Improvement (ACR20/ACR50/ACR70)|ACR20/50/70 response defined as ≥20%, 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%, 50%, or 70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: Patient Global Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity (on a visual analog scale [VAS]); Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP.|Week 24 of the initial treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population|||percentage of participants|||Number
2716251|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
2716926|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of embryos per blastocysts transferred|Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval|Intention to treat population|||embryos per blastocysts transferred||Standard Deviation|Mean
2716252|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during first course of treatment (at any point) were included in the analysis.|||weeks||95% Confidence Interval|Median
2716253|NCT01126541|Secondary|Duration of DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
2716254|NCT01126541|Secondary|Duration of DAS28-CRP Remission After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during initial treatment (at any point) were included in the analysis.|||weeks||95% Confidence Interval|Median
2716255|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
2716256|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population|||weeks||95% Confidence Interval|Median
2716257|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
2716258|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After the First Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population|||weeks||95% Confidence Interval|Median
2716259|NCT01126541|Secondary|DAS28-CRP AUC Weighted Time|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population|||units on a scale*week||Standard Deviation|Mean
2716260|NCT01126541|Secondary|Percentage of Participants Achieving Clinical Remission (DAS28-CRP <2.6) or Low Disease Activity (DAS28-CRP ≤3.2)|Percentage of participants with clinical remission and low disease activity as measured by DAS28-CRP for Arm A and Arm B at Week 24 of the Initial Treatment, at 24 weeks after first re-treatment, and at 24 weeks after second retreatment. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity and <2.6 = remission.|Week 24 of the Initial Treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2716261|NCT01126541|Primary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104|"DAS28-CRP was based on joint counts, overall participant assessment, and serum CRP levels (measured in milligrams per liter [mg/L]) at each visit. Joint counts included swollen joint count (SJC) and tender joint count (TJC). Total score range was 0 to 9.4; a higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and less than (<)2.6 equals (=) remission. The AUC of all DAS28-CRP values between Day 1 and Week 104 (15 values of protocol visits) was calculated using the trapeze method (AUC between t1 and t2=(t2-t1)*((DAS28-CRP at t1 + DAS28-CRP at t2)/2). The true visit dates were used to calculate the time between 2 DAS28-CRP evaluations. All the AUC were censored at Week 104 (linear extrapolation using the 2 last DAS28-CRP values (Weeks 96 and 104) to obtain the true DAS28-CRP value at the true Week 104)."|Week 104|Per Protocol (PP) population: all randomized participants in the Intent-to-Treat (ITT) population (defined as all randomized participants) without major protocol violations. Participants were grouped according to their initially assigned treatment arm irrespective of the treatment actually received.|||score on a scale*week||Standard Error|Mean
2716318|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|"Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions Do you have flushing?."|24 weeks|LOCF, Complete Case ITT Population|||participants|||Number
2716262|NCT01126541|Secondary|DAS28-CRP and Changes From Baseline to Week 24 in DAS28-CRP by Retreatment Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Day 1, 24 weeks following each infusion up to 72 Weeks|ITT Population; number (n)=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2716263|NCT01126541|Secondary|DAS28-CRP During the Initial Treatment|Mean DAS28-CRP at Week 24 of the Initial Treatment study. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, and Weeks 6, 12, and 24|Overall population: all participants with at least one treatment intake.|||units on a scale||Standard Deviation|Mean
2716264|NCT01126437|Secondary|Time to Death From Major Adverse Cardiovascular Event (MACE)|The results presented below are number of patients with death from MACE.|Up to 3 years|TS including vital status follow−up, DAS|||Number of deaths from MACE|||Number
2716265|NCT01126437|Secondary|Time to Onset of First Major Adverse Cardiovascular Event (MACE)|Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.|Up to 3 years|Treated set - on treatment only|||number of patients with MACE|||Number
2716266|NCT01126437|Secondary|Time to First Moderate to Severe COPD Exacerbation|"COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).~Exacerbations classified as follows:~Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.~Results presented below are number of patients with moderate to severe exacerbations."|Up to 3 years|treated set - on treatment only|||number of patients with event|||Number
2716267|NCT01126437|Secondary|Number of Hospitalizations Associated With COPD Exacerbation|Total number of hospitalizations associated with COPD exacerbation.|Up to 3 years|treated set - on treatment only|||number of hospitalizations|||Number
2716268|NCT01126437|Secondary|Time to First Hospitalization Associated With COPD Exacerbation|The results presented below are for the patients with hospitalizations due to COPD exacerbations.|Up to 3 years|treated set - on-treatment only|||Number of patients with event|||Number
2716269|NCT01126437|Secondary|Number of COPD Exacerbations|"The number of COPD exacerbations. COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines)."|Up to 3 years|Treated Set - on treatment only|||number of COPD exacerbations|||Number
2716270|NCT01126437|Secondary|Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)|Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)|Up to 3 years|SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1.|||Liter||Standard Error|Least Squares Mean
2716271|NCT01126437|Primary|Time to First COPD Exacerbation|"Defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).~Onset of exacerbation was defined by the onset of first recorded symptom. The end of exacerbation was decided by the investigator based on clinical judgement.~Exacerbations were classified as follows:~Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization."|Up to 3 years|Treated set (TS, on-treatment only)|||days to event||95% Confidence Interval|Median
2716272|NCT01126437|Primary|Time to All-Cause Mortality|Number of patients with all-cause mortality|Up to 3 years|Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated.|||Number of deaths|||Number
2716296|NCT01126268|Secondary|Number of Participants Who Were a Therapeutic Success|"Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a clinical success and a microbiological success were deemed a therapeutic success, and all others were deemed therapeutic failures."|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716319|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716273|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Speed of Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||msec||Standard Deviation|Mean
2716274|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||Scores on a scale||Standard Deviation|Mean
2716275|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||Scores on a scale||Standard Deviation|Mean
2716276|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Continuity of Attention|Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||Scores on a scale||Standard Deviation|Mean
2716277|NCT01126424|Secondary|Change From Baseline in Postural Stability Test|"The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.~The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut."|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||1/3 degree of angle of sway||Standard Deviation|Mean
2716297|NCT01126268|Secondary|Microbiologic Response at Follow up as Assessed by a Rating Scale|"Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a microbiological success while all others were considered microbiological failure."|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716278|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Power of Attention|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||msec||Standard Deviation|Mean
2716279|NCT01126359|Secondary|Break-through Narcotic Requirement|Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.|20 minutes||||Narcotic Requirements (mg)||95% Confidence Interval|Mean
2716280|NCT01126359|Primary|Visual Analog Scale Pain Score|Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).|20 minutes||||Visial Analog Pain Score (VAS)||95% Confidence Interval|Mean
2716281|NCT01126268|Secondary|Number of Participants Reporting Any Adverse Event (AE)|AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.|baseline to 6 to 8 days after treatment|All participants who received at least 1 dose of Retapamulin (Altabax)|||participants|||Number
2716282|NCT01126268|Secondary|Wound Size at Follow up|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||cm^2||Standard Deviation|Mean
2716283|NCT01126268|Secondary|Wound Size at Baseline|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||cm^2||Standard Deviation|Mean
2716284|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716285|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716286|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716287|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716288|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716289|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716290|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716291|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716292|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716293|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716294|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716927|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with transferred blastocysts|At day 4 and 5|Intention to treat population|||Participants|||Number
2716298|NCT01126268|Secondary|Clinical Response at Follow up as Assessed by a Rating Scale|"Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true clinical success while all others were considered a clinical failure. Patients were classified with an outcome of unable to determine if they missed their follow-up visit or refused clinical examination."|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
2716299|NCT01126268|Primary|Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit|Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.|6 to 8 days after treatment|Participants whose wound cultures were positive for MRSA|||participants|||Number
2716300|NCT01126099|Secondary|Days in Study|The number of days participants remained in the study during the Double Blind Phase. Please note that although the length of follow-up designated in the protocol was 12 weeks, a number of participants were in this phase longer (e.g. the dose titration phase took longer than 3 weeks, assessments were delayed due to scheduling conflicts, etc.) Therefore the length of time in the Double Blind Phase can exceed 12 weeks (84 days).|12 weeks after Baseline|7 participants in the prazosin group were in the double-blind phase longer than 12 weeks (84 days). 4 participants in the placebo group were in the double-blind phase longer than 12 weeks (84 days).|||days||Standard Deviation|Mean
2716301|NCT01126099|Primary|Change in Neuropsychiatric Inventory Score|Neuropsychiatric Inventory score change from Baseline to last observation.The Neuropsychiatric Inventory is a scale that quantifies behavioral and psychiatric symptoms in patients with dementia. The scale ranges from 0 to 144, with 0 being no symptoms.|12 weeks|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.|||units on a scale||Standard Deviation|Mean
2716302|NCT01126099|Secondary|Change in Brief Psychiatric Rating Scale Total Score|Brief Psychiatric Rating Scale score change from Baseline to last observation. The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.|12 Weeks after Baseline|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.|||units on a scale||Standard Deviation|Mean
2716303|NCT01126099|Primary|Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change|This scale represents the raters overall impression of improvement or worsening, and is assessed at the last visit. 1 = Marked improvement, 1 = Moderate improvement, 3 = Minimal improvement, 4 = No change, 5 = Minimal worsening, 6 = Moderate worsening, 7 = Marked worsening.|12 Weeks after Baseline|Any participant who had at least one follow-up assessment was included in the analysis. One participant in the Placebo group did not return for follow-up, and therefore was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2716304|NCT01126060|Primary|Postoperative Drainage Amount|method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL|serial measurement from 1day to 4day after surgery||||mL||Standard Deviation|Mean
2716305|NCT01125930|Secondary|Skin Irritation Assessed by Facial Burning Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
2716306|NCT01125930|Secondary|Skin Irritation Assessed by Facial Itching Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
2716307|NCT01125930|Secondary|Skin Irritation Assessed by Facial Stinging Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
2716308|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
2716309|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716310|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716311|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716312|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Dryness/Irritation|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716313|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Facial Edema|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716314|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Telangiectasia|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716320|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716322|NCT01125930|Secondary|Molecular Evidence of Photodamage|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).|24 weeks|ITT Population that completed baseline and week 24 biopsies|||fold change||Standard Deviation|Mean
2716323|NCT01125930|Secondary|Molecular Markers of Inflammation|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).|24 weeks|ITT Population that completed baseline and Week 24 biopsies|||fold change||Standard Deviation|Mean
2716324|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Papulopustular|Signs of other rosacea subtypes includes papulopustular, inflammatory papule count|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population|||inflammatory papule||Standard Deviation|Mean
2716325|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716326|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716327|NCT01125930|Secondary|Photodamage|Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
2716328|NCT01125930|Secondary|Quality of Life|The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population|||units on a scale||Standard Deviation|Mean
2716329|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT population|||participants|||Number
2716330|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population|||participants|||Number
2716331|NCT01125917|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).|52-week extension phase|The Extension Safety Population (N = 354) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.|||participants|||Number
2716332|NCT01125813|Primary|Efficacy of Treating Bleeding Episodes|"At the end of a bleeding episode, efficacy was assessed as:~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated"|After each bleeding episode, up to 6 month||||Percentage of treatments|bleeding episodes||Number
2716333|NCT01125813|Primary|Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months|Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.|At least 50 Exposure Days and at least 6 months|All subjects who started prophylactic treatment were evaluated.|||Bleeds per month||Standard Deviation|Mean
2716334|NCT01125800|Primary|Percentage of Participants With Objective Response Rate (ORR) by Treatment|The tumor response to the sonidegib treatment was measured by ORR. The ORR was defined as the percentage of participants with partial response or complete response as their best overall response. Participants with stable disease, progressive disease tumor assessment were considered as non-responders. Response evaluation criteria was gadolinium chelate-enhanced brain tumor magnetic resonance imaging (Gd-MRI) for Medulloblastoma and central nervous system (CNS) tumors and response evaluation criteria in solid tumors (RECIST) version 1.0 for non-CNS tumors assessed by MRI. Complete Response (CR), Progressive Disease (PD) and Incomplete Response/Stable Disease (SD) were defined as disappearance of all non-target lesions, unequivocal progression of existing non-target lesions and Neither CR nor PD, respectively.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.|||Percentage of participants|||Number
2716335|NCT01125800|Secondary|Duration of Response by Treatment|Duration of overall response (complete response (CR) or partial response (PR)) was calculated for those participants whose best overall response was CR or PR. The start date was the date of the first documented tumor response (CR or PR) and the end date was the date of the event defined as the first documented progression or death due to underlying cancer or after the same treatment line. If a participant did not have a progression or death, the duration of response was censored at the date of last adequate tumor assessment in that treatment line.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|"The analysis was performed in FAS population. Here Number of participants analysed” signifies treatment responders for the specified reporting group."|||months||Full Range|Median
2716336|NCT01125800|Secondary|Percentage of Pediatric Participants With Objective Response Rate (ORR) by Hedgehog (Hh) Signaling Pathway Status|ORR was determined in the participants with mutations on Hh gene (Hh positive) and the participants without mutations on Hh gene (Hh negative).|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|60 patients with known (Hedgehog) Hh pathway activation status were analyzed, 10 patients, including all 5 patients with an objective response (3 with pediatric) , were Hh-positive (+). No Hh-negative patient had an objective response.|||% pediatric Hh + responders|||Number
2716337|NCT01125800|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sonidegib in Phase I|Maximum observed plasma concentration following drug administration was calculated from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||nanograms/millitres(ng/mL)||Standard Deviation|Mean
2716338|NCT01125800|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sonidegib in Phase I|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||hours||Full Range|Median
2716339|NCT01125800|Secondary|Area Under the Drug Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24h) of Sonidegib in Phase I|AUC(0-24h) was defined as the area under the drug concentration time curve calculated using linear trapezoidal summation from time zero to 24 hours after dosing.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in pharmacokinetic analysis set (PAS), defined as all the participants who received at least one (full or partial) dose of sonidegib and provided at least one evaluable pharmacokinetic (PK) blood sample. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||nanograms*hours/millilitres (ng*hr/mL)||Standard Deviation|Mean
2716340|NCT01125800|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. On-treatment deaths were deaths which occurred up to 30 days after last date of study treatment.|Baseline (start of study treatment) up to End of treatment (Within 14 days of last dose)|The analysis was performed in safety set (SS), defined as all the participants who received at least 1 dose of sonidegib.|||participants|||Number
2716341|NCT01125800|Primary|Maximum Tolerated Dose (MTD) of Sonidegib for Prolonged Use|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose-limiting toxicity (DLT), based on Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications.k|Baseline, End of dose escalation part (Day 42)|The MTD for the pediatric population was not established in this study. MTD was not achieved since 1 or no DLT was observed. The recommended phase II dose was established based on the safety, pharmacokinetics, and clinical responses observed.|||mg/m^2|||Number
2716342|NCT01125800|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Phase I|DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC <1.0x10^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets <50x10^9/L); ≥ CTCAE grade 3 anemia (Hgb <80 g/L); Febrile neutropenia (ANC <1x10^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (>1.5ULN) together with ≥ grade 3 ALT elevation (>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment.|Baseline, End of dose escalation part (Day 42)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.|||participants|||Number
2716343|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline|"Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. On-drug headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle."|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.|||Days per month||Standard Error|Mean
2716377|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 24 Hours Postdose|Urine was collected 24 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 24 hours.|24 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
2716344|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|"Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. On-drug headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle."|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.|||Days per month||Standard Error|Mean
2716345|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|"Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. On-drug headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle."|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.|||Days per month||Standard Error|Mean
2716346|NCT01125774|Secondary|Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.|||Days per month||Standard Error|Mean
2716347|NCT01125774|Primary|Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.|||Days per month||Standard Error|Mean
2716348|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
2716356|NCT01125722|Secondary|Change in Mean Volume Per Void|Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||mL||Standard Deviation|Mean
2716349|NCT01125774|Primary|Number of Participants With Laboratory AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
2716350|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 6 months|APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
2716351|NCT01125774|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 14 days after the last dose of study drug (Up to 6.5 months)|All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
2716352|NCT01125748|Secondary|Time to the First Protocol-defined Severe Exacerbation|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.|||Weeks||95% Confidence Interval|Mean
2716353|NCT01125748|Primary|Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2716354|NCT01125722|Secondary|Change in Mean Overactive Bladder Symptom Composite Score|The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||scores on a scale||Standard Deviation|Mean
2716355|NCT01125722|Secondary|Change in Mean Urgency Episodes Per Day|Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||number of urgency episodes per 24 hours||Standard Deviation|Mean
2716404|NCT01125189|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (day 1) up to follow-up Week 48|All treated participants.|||participants|||Number
2716357|NCT01125722|Secondary|Change in Mean Daily Voiding Frequency|Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||number of voids per 24 hours||Standard Deviation|Mean
2716358|NCT01125722|Primary|Change in Mean Daily Urgency Incontinence Episodes|Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||number of incontinence episodes/24 hours||Standard Deviation|Mean
2716359|NCT01125605|Primary|Tolerability After Visit 2 and Visit 3|Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects|appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured|||participants|||Number
2716360|NCT01125605|Primary|Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation|The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits|||participants|||Number
2716361|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.~The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values|||participants|||Number
2716362|NCT01125605|Primary|Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation|The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits|||participants|||Number
2716363|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.~The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values|||participants|||Number
2716364|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
2716365|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
2716366|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment|"The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
2716367|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication|"The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
2716422|NCT01124955|Secondary|Quality of Life Assessed on the SF-36|Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life.|Days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)|||scores on a scale|Participants|Standard Deviation|Mean
2716368|NCT01125605|Secondary|Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration|"The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).~Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)"|begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))|exploratively, all participations with values|||units on a scale||Standard Deviation|Mean
2716369|NCT01125605|Primary|Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3|The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits|||units on a scale||Standard Deviation|Mean
2716370|NCT01125566|Secondary|Objective Response (OR)|"OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.~Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR"|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months)|RS including participants with available data for OR.|||Percentage of participants (%)|||Number
2716371|NCT01125566|Secondary|Best RECIST Assessment|"Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (PD) or not evaluable by investigator (RECIST version 1.1).~CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months|RS including participants with available data for best RECIST assessment.|||Percentage of participants|||Number
2716372|NCT01125566|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death irrespective of the cause of the death.~For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date."|From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.|RS including participants with available data for OS.|||Months||Inter-Quartile Range|Median
2716373|NCT01125566|Primary|Progression-free Survival (PFS)|"PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment.~Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.~Progression of disease was determined if at least 1 of the following criteria applied:~At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of 1 or more new lesions~Unequivocal progression of existing non-target lesions"|From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months|Randomised set (RS): The randomised set included all participants who were randomised to receive treatment, whether treated or not.|||Months||Inter-Quartile Range|Median
2716374|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.|||mL/mg||Standard Deviation|Mean
2716375|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.|||mL/mg||Standard Deviation|Mean
2716376|NCT01125514|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure was measured three times at 1 to 2-minute intervals. The mean of the three sitting blood pressure measurements was used as the average of the sitting office blood pressure. The msSBP and msDBP data were analyzed using a mixed effect model with fixed effects from treatment and treatment*time; random effect from patients and predose as covariate.|0.5 hour pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose.|Safety analysis set include subjects that received study drug.|||mmHg||Standard Error|Least Squares Mean
2716378|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 12 Hours Postdose|Urine was collected 12 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 12 hours.|12 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
2716379|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 8 Hours Postdose|Urine was collected 8 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 8 hours.|8 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
2716380|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 4 Hours Postdose|Urine was collected 4 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 4 hours.|4 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
2716381|NCT01125514|Secondary|Creatinine Clearance|Creatinine clearance= (Urine creatinine/Serum creatinine) x (Urine volume/(24*60)).|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.|||mL/min||Standard Deviation|Mean
2716382|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Renal Clearance (CLR)|The renal clearance of drug [volume x time-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.|||L/h||Standard Deviation|Mean
2716383|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Amount of Drug Excreted Into the Urine From Time Zero to 24 Hours After Administration (Ae0-24)|The area under the plasma (or serum or blood) concentration-time curve from time zero to 24 h [mass × time × volume-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set|||mg||Standard Deviation|Mean
2716384|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin, ss)|The minimum observed steady-state drug concentration in the plasma, blood, serum, or other body fluids at the end of the dosing interval during multiple dosing [amount x volume-1]|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set|||ng/mL||Standard Deviation|Mean
2716385|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Average Steady State Plasma Concentration During Multiple Dosing (Cav,ss)|The average steady-state drug concentration in the plasma, blood, serum, or other body fluids during multiple dosing [amount x volume-1]. This was estimated as AUCτ/τ|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All subjects with evaluable pharmacokinetic parameter data with no exclusion flags and no major protocol deviations.|||ng/mL||Standard Deviation|Mean
2716386|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Tmax was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set|||Hours||Full Range|Median
2716387|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)|Cmax,ss was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set|||ng/mL||Standard Deviation|Mean
2716388|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Area Under the Plasma Concentration-time Curve (AUC)|"Pharmacokinetic (PK) parameters were determined from the plasma concentration time profile of furosemide using a non-compartmental method:~AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval~AUC (0-24): Area under the plasma concentration-time curve from time zero to 24 hours~AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis.~AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable Pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set.|||h*ng/mL||Standard Deviation|Mean
2716389|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol/mg||Standard Deviation|Mean
2716421|NCT01124955|Secondary|Likert Improvement Assessment Scale|Likert improvement assessment scale is based on the patient's opinion (LIKERT P) and assessor's opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days.|Days 0, 3, 7, 14 and 21||||scores on a scale||Standard Deviation|Mean
2716390|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol/mg||Standard Deviation|Mean
2716391|NCT01125202|Primary|Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|Baseline to 16 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
2716392|NCT01125202|Primary|Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. The difference between measurement time points was determined.|Baseline to 8 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
2716393|NCT01125202|Primary|Time Specific Dietary Sodium Intake (16 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|16 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
2716394|NCT01125202|Primary|Time Specific Dietary Sodium Intake (8 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|8 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
2716395|NCT01125202|Primary|Time Specific Dietary Sodium Intake (Baseline)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|Baseline|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
2716396|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (16 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.|16 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
2716397|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (12 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.|12 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
2716398|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (8 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.|8 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
2716399|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (Baseline)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.|Baseline|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
2716400|NCT01125189|Secondary|Percentage of Resistant Variants Associated With Virologic Failure|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA < LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome."|Follow-up Week 48|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2716401|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)|SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Follow-up Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
2716402|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
2716403|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 4|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
2716405|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)|SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
2716406|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.|Weeks 4 and 12|All treated participants. Here, 'number of participants' analyzed (N) signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
2716407|NCT01125176|Secondary|Overall Survival|Measured from time of study drug administration to death, measured in months.|From date of study drug initiation to date of death, assessed through study completion.||2020-06-30|06/2020||||
2716408|NCT01125176|Secondary|Time to Response|Measured from time of study drug administration to initial response (partial or complete), measured in months.|From date of study drug initiation to date of initial response, assessed up to 6 months.||2020-06-30|06/2020||||
2716409|NCT01125176|Secondary|Duration of Response|Measured from end of treatment to progression or death, measured in months.|From date of end of treatment to progression or death, whichever occurs first, assessed through study completion.||2020-06-30|06/2020||||
2716410|NCT01125176|Secondary|Progression Free Survival|Measured from time of study drug administration to progression or death, measured in months.|From date of study drug initiation until date of progression or death, whichever occurs first, assessed through study completion.||2020-06-30|06/2020||||
2716411|NCT01125176|Primary|Overall Response Rate as Defined as the Number of Patients Who Experience a Response (Complete or Partial) to Treatment at the Time of Best Response|Response will be evaluated in this study using the International Workshop on CLL (IWCLL) update of the 1996 NCI-Working Group criteria for CLL, which includes assessment of the following: clonal lymphocytes in the peripheral blood by flow cytometry, blood tests for neutrophil count, hemoglobin, and platelet count, CT examination for lymphadenopathy, hepatomegaly, splenomegaly, constitutional symptoms, bone marrow assessment via biopsy/aspirate, and evaluation for disease transformation.|From date of study drug initiation until date of best response, assessed up to 6 years.||||Participants|||Count of Participants
2716412|NCT01125163|Secondary|Number of Participants Who Received Red Cell Transfusions During Intervention Period|The numbers below represent the number of participants in each arm that received a transfusion during intervention period.|from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner||||participants|||Number
2716413|NCT01125163|Primary|Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)|For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.|at 36 weeks adjusted postmenstrual age|Sample size was based on a retrospective observational pilot study from the 2008 calendar year. A sample size of 75 per group was chosen to achieve 80% power to detect a difference in Hct of 2 % between groups, assuming a mean Hct of 25.6% in the control group, a standard deviation 4.4%, with alpha level (0.05) using a two-sided two-sample t-test.|||% Hematocrit||Standard Deviation|Mean
2716414|NCT01125098|Secondary|To Verify the Duration of Hospitalization for Severe Exacerbation in COPD Patients Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the duration in days in case of hospitalization for severe COPD exacerbation in COPD patients in the study population, both in the PRO-CT-guided antibiotic treatment group and in the standard antibiotic treatment group.|Discharge/10 days-6 months||2014-11-30|11/2014||||
2716415|NCT01125098|Secondary|To Verify Changes in FEV1 Value in COPD Patients Comparing Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|COPD patients of the study population will undergo spirometry on visit 1, 4, 5, 7 in order to evaluate if there is change in FEV1 among COPD patients, both in the PRO-CT Group and in the standard Group.|Discharge/10 days-6 months||2014-11-30|11/2014||||
2716416|NCT01125098|Secondary|To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the number of deaths from any cause among COPD patients in the study population, in order to compare survival among patients both in PRO-CT group and in the standard group.|Discharge/10 days-6 months||2014-11-30|11/2014||||
2716417|NCT01125098|Secondary|To Evaluate if the PRO-CT-guided Decision Making to Shorten Antibiotic Therapy is Less Effective Than the Guideline Recommended Standard Antibiotic Treatment in Preventing Hospitalization.|We evaluate the number of hospital re-admissions for severe COPD exacerbation in COPD patients of the study population, both in the PRO-CT group and in the standard group, in order to assess if shortening antibiotic therapy taking into account the values of PRO-CT is less effective compared to a standard antibiotic treatment.|Discharge/10 days-6 months||2014-11-30|11/2014||||
2716418|NCT01125098|Secondary|Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.||Discharge /10 days-6 months|||||||
2716419|NCT01125098|Primary|To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.|We prospectively recruited COPD patients hospitalized for severe exacerbation of COPD and followed them after discharge. The primary end point of the study was the number of patients with at least 1 exacerbation at 6 months after the index exacerbation that was the reason for their hospital admission.|6 months||||participants|||Number
2716420|NCT01124955|Secondary|Number of Anti-inflammatory Tablets Taken|Number of 50 mg sodium diclofenac pills taken per day|Days 3,7,14,21 and 28|Intention to treat (ITT)|||number of pills/day||Standard Deviation|Mean
2716928|NCT01121666|Secondary|Embryo Quality: Absence of Multinucleation|"Main embryo quality parameter absence of multinucleation observed."|Day 3|Intention to treat population|||Percentage of absent multinucleation|||Number
2716423|NCT01124955|Secondary|Roland-Morris Disability Questionnaire (RM)|"Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity.~0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity)."|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)|||scores on a scale|Participants|Standard Deviation|Mean
2716424|NCT01124955|Primary|Pain Assessed on a 10-point Numeric Pain Scale|The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session.|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)|||cm|Participants|Standard Deviation|Mean
2716425|NCT01124916|Secondary|Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.|6 Months|The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention.|||units on a scale||Standard Deviation|Mean
2716426|NCT01124916|Primary|Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.|6 Weeks|The analysis for the primary outcome includes all randomized subjects.|||Dollars||Standard Deviation|Mean
2716427|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for concentration max. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.|||ng/mL||Standard Deviation|Mean
2716428|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve last. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.|||h*ng/mL||Standard Deviation|Mean
2716429|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve infinity. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.|||h*ng/mL||Standard Deviation|Mean
2716430|NCT01124864|Secondary|Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment. A Novartis modified response evaluation criteria in solid tumors RECIST 1.1 criteria was applied to CT/MRI imaging data when assessing any responses to AUY922 treatment. All images were evaluated locally by the investigator. All complete or partial responses were confirmed by a second assessment at least 4 weeks later.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.|||Percentage of participants|||Number
2716431|NCT01124864|Secondary|Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review|Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.|||Percentage of participants|||Number
2716432|NCT01124864|Primary|Response Assessment by Study Stratum - Per Investigator Assessment|The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.|18 weeks|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.|||Participants|||Number
2716433|NCT01124838|Secondary|Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2716463|NCT01124643|Primary|Change From Baseline in Left Ventricular Mass Indexed to Height (LVMI)||Baseline to 12 months|The Intent-to-Treat (ITT) participant population in this study was defined as all participants who provided informed consent and received study drug. Participants who did not have left ventricular hypertrophy were not included in this analysis.|||g/m^2.7||Standard Deviation|Mean
2716434|NCT01124838|Secondary|Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2716435|NCT01124838|Secondary|Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2716436|NCT01124838|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2716437|NCT01124838|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.|Central retinal thickness was measured using OCT and assessed by a central reader.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2716438|NCT01124838|Secondary|Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline|||months||Inter-Quartile Range|Median
2716439|NCT01124838|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||logMAR||Standard Deviation|Mean
2716440|NCT01124838|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured."|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2716441|NCT01124838|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell~Grade 0.5+ = 1 - 5 cells~Grade 1+ = 6 - 15 cells~Grade 2+ = 16 - 25 cells~Grade 3+ = 26 - 50 cells~Grade 4+ = > 50 cells."|Baseline and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2716460|NCT01124643|Secondary|Change From Baseline in the Minnesota Living With Heart Failure Questionnaire (MLHF- Q)|The MLHF-Q contains 21 questions with answers ranging from 0 (no) to 5 (very much). The final score ( 0 to 105) is the sum of the points for the 21 questions. A higher score indicates a worse quality of life.|Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||units on a scale||Standard Deviation|Mean
2716461|NCT01124643|Secondary|Change From Baseline in Distance Walked in 6- Minute Walk Test (6MWT)||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.|||meters||Standard Deviation|Mean
2716462|NCT01124643|Secondary|Change From Baseline in Maximal Oxygen Consumption (VO2max) at Peak Exercise||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.|||(mL/min/kg)||Standard Deviation|Mean
2716442|NCT01124838|Primary|Time to Treatment Failure on or After Week 2|"Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:~New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline~2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.~Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 3 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.|||months||Inter-Quartile Range|Median
2716443|NCT01124786|Secondary|Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling||30 days after first dose|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716444|NCT01124786|Secondary|Change From Baseline in Health Status||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716445|NCT01124786|Secondary|Change From Baseline in Pain Severity||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716446|NCT01124786|Secondary|Drug Tolerability and Toxicity||Every week, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716447|NCT01124786|Secondary|Cancer Antigen (CA)19-9 Response Rates||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716448|NCT01124786|Secondary|ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years||Every 8 weeks|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716449|NCT01124786|Secondary|Overall Survival in All Patients and Patients With hENT1 Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
2716450|NCT01124786|Primary|Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years.|Analysis was per protocol and included hENT-1 low Intent to Treat (IIT) population.|||months||95% Confidence Interval|Median
2716451|NCT01124734|Secondary|Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers)|The effect outcome is measured by the change in percentage of circulating lymphocyte cells (autoimmune biomarkers) that express the noted phenotype. This percentage change is determined by comparing the values obtained within 7 days of participant going off treatment against the baseline values.|2 years|Of the 17 qualifying participants, 9 underwent baseline (pre-Course 1) testing. Eleven participants consented to and underwent this POST off- treatment testing. Two of the participants tested at Post treatment did not have baseline testing done.|||Percentage of Cells||Standard Deviation|Mean
2716452|NCT01124734|Primary|Safety and Toxicity of H-D IL-2 Followed by Low Dose Temozolomide|Safety and toxicity in this study population was evaluated using the NCI Common Toxicity Criteria. The unit of measure is the number of study participants with one or more unexpected and related (even remotely) SAE.|2 years||||Participants|||Count of Participants
2716453|NCT01124734|Primary|Duration of Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide|Duration of response is defined as the length (measured in days) from the date of best response to the date of progression (if any), or to the date of last follow-up (if no progression is observed). The duration of response is applicable for those CR/MR/PR/SD subjects only.|8 years|Duration of response is applicable for those CR/MR/PR/SD subjects only.|||Days||95% Confidence Interval|Mean
2716454|NCT01124734|Primary|Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide|Clinical response was measured using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria categorizing responses as complete response (CR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD).|2 years||||Participants|||Count of Participants
2716455|NCT01124643|Primary|Safety Evaluations||Baseline to 12 months|ITT population|||participants|||Number
2716456|NCT01124643|Secondary|Change From Baseline in Albumin/Creatinine (A/Cr) Ratio||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||Ratio||Standard Deviation|Mean
2716457|NCT01124643|Secondary|Change From Baseline in eGFR||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||(mL/min/1.73m^2)||Standard Deviation|Mean
2716458|NCT01124643|Secondary|Change From Baseline in Plasma Gb3||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||(nmol/mL)||Standard Deviation|Mean
2716459|NCT01124643|Secondary|Change From Baseline in New York Heart Association (NYHA) Functional Class|"Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea.~Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline to 12 months|ITT population.|||participants|||Number
2716496|NCT01124448|Secondary|Evidence of Changes in the Metabolic Profile of Urine||One year|||||||
2716497|NCT01124448|Secondary|Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples||one year|||||||
2716464|NCT01124617|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716465|NCT01124617|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|Participants rated the overall quality of sleep last night as excellent, good, fair and poor.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716466|NCT01124617|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was related to How many times did the participant wake up during the night. Lesser number signifies better sleep."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716467|NCT01124617|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was related to How long did the participant sleep last night. The mean change for the time in hours slept during the last night was reported."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Hours||Standard Deviation|Mean
2716468|NCT01124617|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was related to How long after bedtime or lights out did the participant fall asleep last night . Decrease in time indicates an improvement."|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Minutes||Standard Deviation|Mean
2716469|NCT01124617|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716470|NCT01124617|Secondary|Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716471|NCT01124617|Secondary|Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716472|NCT01124617|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and ineffective."|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716473|NCT01124617|Secondary|Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716474|NCT01124617|Secondary|Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)|Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.|||Percentage of participants|||Number
2716475|NCT01124617|Secondary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.|||Units on a scale||Standard Deviation|Mean
2716476|NCT01124617|Primary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.|Baseline and Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
2716477|NCT01124604|Other Pre-specified|Serum Concentration of Tapentadol||Week 2, 4, 8, 12|Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 serum study drug concentration. 'N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||nanogram per milliliter||Standard Deviation|Mean
2716478|NCT01124604|Other Pre-specified|Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)|COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.|Week 12|Safety population included all the participants who received at least 1 dose of the study drug.|||Participants|||Number
2716479|NCT01124604|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12|"RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as Yes/No where Yes is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716480|NCT01124604|Secondary|Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12|WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716481|NCT01124604|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716482|NCT01124604|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|"Overall quality of sleep was addressed by the question: Please rate the overall quality of your sleep last night and participants could choose one of the following options: excellent, good, fair or poor."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716483|NCT01124604|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was addressed by the question: How many times did you wake up during the night?'' and lesser number signified better sleep."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716498|NCT01124448|Primary|Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts|Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk|one week||||log10 CFU/mL||95% Confidence Interval|Mean
2716484|NCT01124604|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was addressed by the question: How long did you sleep last night? and the change from Baseline in time slept was reported."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Hours||Standard Deviation|Mean
2716485|NCT01124604|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was addressed by the question: How long after bedtime/lights out did you fall asleep last night? and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Minutes||Standard Deviation|Mean
2716486|NCT01124604|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12|BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2716487|NCT01124604|Secondary|Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716488|NCT01124604|Secondary|Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|"BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: Do you have any pain today other than everyday kinds of pain? on a 2-point scale of yes or no."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716489|NCT01124604|Secondary|Number of Participants With Response Based on Physician's Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and not effective."|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716490|NCT01124604|Secondary|Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2716491|NCT01124604|Secondary|Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)|Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.|||Percentage of participants||95% Confidence Interval|Number
2716492|NCT01124604|Secondary|Change From Baseline in 11-point Numerical Rating Scale (NRS)|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. LOCF method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
2716493|NCT01124604|Primary|Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
2716494|NCT01124448|Secondary|Evidence of Changes in the Immunological Profile of Milk||one year|||||||
2716495|NCT01124448|Secondary|Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk||One year|||||||
2716499|NCT01124422|Secondary|Baseline Dyspnea Index (BDI) at Week 4 and Transition Dyspnea Index (TDI) at Week 8|The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9.|BDI: Week 4; TDI: Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||Standard Error|Mean
2716500|NCT01124422|Secondary|Mean Change in Scores on the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS) Questionnaire From Week 4 to Week 8|The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing).|Week 4 and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||Standard Error|Mean
2716501|NCT01124422|Secondary|Mean Change in EIC at 2 to 3.5 Minutes During the Exercise Period From Baseline (Week 3) to Week 8|The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL||Standard Error|Mean
2716502|NCT01124422|Secondary|Mean Change in Ratio of Respiratory Rate (RR) to Tidal Volume (VT) or RR/VT at Isotime During the Course of the ESWT From Baseline to Week 8|The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||breaths/min/L||Standard Error|Mean
2716503|NCT01124422|Secondary|Mean Change in HR Per Time Slope During the Course of the ESWT Using Pulse Oximetry From Baseline to Week 8 (Non-OMS Subgroup)|HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed. A subgroup of participants specified sites provided cardio-respiratory and exercise IC measurements with the Oxycon Mobile System (OMS). Participants not at these sites formed the non-OMS subgroup.|||bpm/min||Standard Error|Mean
2716504|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) at Isotime During the Course of the ESWT From Baseline to Week 8|VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||L||Standard Error|Mean
2716505|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) Per Time Slope During the Course of the ESWT From Baseline to Week 8|VT is the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||L/min||Standard Error|Mean
2716506|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) at Isotime During the Course of the ESWT From Baseline to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||breaths/min||Standard Error|Mean
2716507|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||breaths/min/min||Standard Error|Mean
2716508|NCT01124422|Secondary|Mean Change in Respiratory Exchange Ratio (RER) Per Time Slope During the Course of the ESWT From Baseline to Week 8|The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Ratio of VCO2 and VO2||Standard Error|Mean
2716509|NCT01124422|Secondary|Mean Change in Heart Rate (HR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||bpm/min||Standard Error|Mean
2716510|NCT01124422|Secondary|Mean Change in Minute Ventilation (V'E) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Liter (L)/min||Standard Error|Mean
2716511|NCT01124422|Secondary|Mean Change in Flow of Carbon Dioxide (V'CO2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL/min||Standard Error|Mean
2716512|NCT01124422|Secondary|Mean Change in Flow of Oxygen (V'O2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL/minute (min)||Standard Error|Mean
2716513|NCT01124422|Secondary|Mean Change in Exercise Inspiratory Capacity (EIC) at the End of Exercise From Baseline (Week 3) to Week 8|EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL||Standard Error|Mean
2716514|NCT01124422|Secondary|Mean Change in Pre-dose and Post-dose Resting Inspiratory Capacity (IC) From Baseline (Week 4) to Week 8|Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4.|Baseline (Week 4) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Milliliters (mL)||Standard Error|Mean
2716515|NCT01124422|Secondary|Mean Change in EDS at Isotime From Baseline (Week 3) to Week 8|EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||Standard Error|Mean
2716516|NCT01124422|Secondary|Mean Change in Scores on the Exercise Dyspnea Scale (EDS) From Baseline (Week 3) to Week 8|EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale/minute||Standard Error|Mean
2716517|NCT01124422|Primary|Mean Change in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8|EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to study drug. Only those participants contributing data at the indicated time points were analyzed.|||Seconds (sec)||Standard Error|Mean
2716594|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage (%) of subjects|||Number
2716518|NCT01124370|Secondary|NYHA Functional Class Improvement From Baseline to 6 Months|"Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.~NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.~NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases."|Baseline and 6 months on therapy|Heart failure subjects with 6 month data.|||participants|||Number
2716519|NCT01124370|Secondary|Six-minute Hall Walk Test Change From Baseline at 6 Months|Change = Month 6 score - Baseline score|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.|||meters||Standard Deviation|Mean
2716520|NCT01124370|Secondary|Heart Failure Clinical Composite|"The composite is determined according to the following definitions.~Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF.~Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward.~Unchanged: patient was neither improved nor worsened."|6 months on therapy|Evaluable subjects with heart failure at baseline.|||participants|||Number
2716521|NCT01124370|Secondary|Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months|Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.|Baseline and 6 months on therapy|Heart failure subjects with baseline and 6 month results.|||units on a scale||Standard Deviation|Mean
2716522|NCT01124370|Secondary|Epworth Sleepiness Scale Change From Baseline at 6 Months|Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.|||units on a scale||Standard Deviation|Mean
2716523|NCT01124370|Secondary|Related Adverse Events|The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.|Up to 2 years|Subjects with an implant attempt.|||participants|||Number
2716524|NCT01124370|Primary|AHI Change From Baseline at 3 Months|Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|Baseline and 3 months on therapy|The evaluable population includes subjects who completed a 3 Month post therapy initiation visit.|||events/hour||Standard Deviation|Mean
2716525|NCT01124305|Secondary|Limb Alignment (Mechanical Axis)|"Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment (bow-legged) is shown as a negative number in degrees away from 0. Valgus alignment (Knock-kneed) is expressed as a positive number in degrees away from 0."|4 months|All participants were x-rayed postoperatively to measure the mechanical axis of the leg in degrees.|||degrees varus(-) or valgus(+)||Full Range|Mean
2716526|NCT01124305|Secondary|Number of Instrument Trays Required||1 day|per protocol|||number of trays||Standard Deviation|Mean
2716527|NCT01124305|Secondary|Length of Each Surgical Step (in Seconds)|surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure|1 day|per protocol|||seconds||Standard Deviation|Mean
2716528|NCT01124305|Primary|Length of Surgery|Time elapsed from skin incision to wound closure (in seconds)|1 day|per protocol|||seconds||Standard Deviation|Mean
2716529|NCT01124292|Primary|Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.|Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective|24 months||||scores on a scale||Standard Deviation|Mean
2716530|NCT01124292|Primary|Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting.~Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
2716595|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage (%) of subjects|||Number
2716531|NCT01124292|Primary|Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored CALL button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance.~Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
2716532|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.~Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.~Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.~Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.~Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months||||Navigation Errors||Standard Deviation|Mean
2716533|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Completion Time)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.~Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.~Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.~Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.~Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
2716534|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||pixel^2/1000||Standard Deviation|Mean
2716535|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Completion Time)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
2716536|NCT01124292|Primary|Information Transfer Rate (Percentage of Correctly Completed Commands)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months||||Percentage of correctly completed cmd(%)||Standard Deviation|Mean
2716537|NCT01124292|Primary|Information Transfer Rate (ITR)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months||||bits per minute||Standard Deviation|Mean
2716601|NCT01123941|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.|During the 7-day period after vaccination||||participants|||Number
2716538|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
2716539|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
2716540|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
2716541|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
2716542|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
2716543|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
2716544|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
2716545|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
2716571|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation|Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716546|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
2716547|NCT01124188|Secondary|Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks|"Change in SPPB scores from randomization to 14 weeks for both arms.~The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance"|Baseline and 14 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2716548|NCT01124188|Secondary|Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks|"Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).~Improvement of 30% is clinically meaningful"|Baseline and 14 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2716549|NCT01124188|Primary|Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization|The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores < or = to 5 AND Numeric Rating Scale for pain (NRS) > or = 30% reduction from study entry.|14 weeks||||Participants|||Count of Participants
2716550|NCT01124175|Secondary|AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2716551|NCT01124175|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2716552|NCT01124175|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2716553|NCT01124175|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.|||ng*h/mL||Standard Deviation|Mean
2716554|NCT01124175|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.|||ng*h/mL||Standard Deviation|Mean
2716555|NCT01124175|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.|||ng/mL||Standard Deviation|Mean
2716556|NCT01124162|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losaran Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2716557|NCT01124162|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2716558|NCT01124162|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2716559|NCT01124162|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2716560|NCT01124162|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2716561|NCT01124162|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2716665|NCT01123356|Secondary|Dose Reductions Due to Adverse Events.|Number of dose reductions due to toxicity.|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.|||dose reductions|||Number
2716562|NCT01124149|Secondary|Percentage of Subjects in Partial Remission at Week 8 of Acute Phase|"Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
2716563|NCT01124149|Secondary|Percentage of Subjects in Complete Remission at Week 8 of Acute Phase|"Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 Weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
2716564|NCT01124149|Secondary|Improvement in Stool Frequency Symptoms During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point.~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
2716565|NCT01124149|Secondary|Improvement in Rectal Bleeding Score During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point.~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
2716566|NCT01124149|Secondary|Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase|"Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
2716567|NCT01124149|Secondary|Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase|Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
2716568|NCT01124149|Secondary|Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase|"Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency.~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
2716569|NCT01124149|Primary|Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase|"Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
2716570|NCT01124097|Primary|Change From Baseline to Endpoint in Mean Pain|"The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.~The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [0 = no pain; 10 = the most intense pain imaginable]"|baseline to endpoint|efficacy population|||units on a scale||Standard Error|Least Squares Mean
2716596|NCT01123980|Secondary|9-point Plasma Glucose Profiles|Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day.|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||mmol/L||Standard Error|Mean
2716572|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia|Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716573|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity|Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716574|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis|Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716575|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon|Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716576|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis|Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716577|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection|Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716578|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection|Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716579|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity|Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716580|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade|Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716592|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - Severe and Minor|Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L.|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).|||episodes|||Number
2716581|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade|Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits.|||Percentage of patients|||Number
2716582|NCT01124045|Secondary|Global Assessment Score of Postoperative Inflammation by Visit|A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
2716583|NCT01124045|Primary|Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days|Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.|Day 15 ± 2 days|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits.|||Percentage of patients|||Number
2716584|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
2716585|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population|||participants|||Number
2716586|NCT01124006|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the MCS, SF-36 at Baseline."|||units on a scale||Standard Deviation|Mean
2716587|NCT01124006|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the PCS, SF-36 at Baseline."|||units on a scale||Standard Deviation|Mean
2716588|NCT01124006|Secondary|Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.|The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
2716589|NCT01124006|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12-month|FAS Population|||units on a scale||Standard Deviation|Mean
2716590|NCT01124006|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment."|||participants|||Number
2716591|NCT01123980|Secondary|Number of Hypoglycaemic Episodes|All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).|||episodes|||Number
2716593|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - All||Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).|||episodes|||Number
2716602|NCT01123928|Secondary|"Belief That Doctors and Nurses at the Hospital Have Very Good Attitudes"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
2716603|NCT01123928|Secondary|"Belief That Surgeons at the Hospital Are Highly Skilled"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
2716604|NCT01123928|Secondary|"Belief That Vision Will Improve a Lot Following Surgery"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
2716605|NCT01123928|Secondary|Belief That Surgery Will be Painful|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
2716606|NCT01123928|Secondary|Knowledge That Cataract Can be Treated|Measured as a percentage of subjects who correctly answer the question in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
2716607|NCT01123928|Secondary|Attendance at Hospital for Pre-operative Examination|Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.|||percentage of participants|||Number
2716608|NCT01123928|Primary|Decision to Undergo Cataract Surgery (Surgery Acceptance)|Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.|||percentage of participants|||Number
2716609|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|15 minutes prior to initial injection of corticosteroid versus platelet rich plasma||||units on a scale||Standard Deviation|Mean
2716610|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|12 weeks from initial injection of corticosteroid versus platelet rich plasma||||units on a scale||Standard Deviation|Mean
2716611|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|6 weeks from initial injection of corticosteroid versus platelet rich plasma||||units on a scale||Standard Deviation|Mean
2716612|NCT01123850|Secondary|Outcome Measure - Pain, Life Quality, Satisfaction||PreOp, Surgery, 6M, 12M|Study was terminated due to slow enrollment, there was no data analysis||||||
2716613|NCT01123850|Primary|Fusion Assessment|Fusion at 12M using radiograph Fusion Mass at 12M using CT|6 M, 12 M|Study was terminated due to slow enrollment, there was no data analysis||||||
2716614|NCT01123655|Secondary|Vitals - Respirations|Respirations represents breaths per minute|0 weeks and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||breaths per minute||Standard Error|Mean
2716615|NCT01123655|Secondary|Vitals - Blood Pressure|measurement of blood pressure (mmHg)|0 weeks and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||mm Hg||Standard Error|Mean
2716616|NCT01123655|Secondary|Weight|Weight in kg|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||kilograms||Standard Error|Mean
2716617|NCT01123655|Secondary|Vital Sign - Pulse|heartbeats per minute|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||beats per minute||Standard Error|Mean
2716618|NCT01123655|Secondary|Vital Signs-Temperature||0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||degrees Fahrenheit||Standard Error|Mean
2716619|NCT01123655|Secondary|CDAI|Clinical Disease Activity Index (CDAI) 0-76 mm. Interpretation of CDAI scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity.|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||centimeters||Standard Error|Mean
2716620|NCT01123655|Secondary|Duration of Morning Stiffness in Joints|Duration of morning stiffness in the joints, in minutes.|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||minutes||Standard Error|Mean
2716621|NCT01123655|Secondary|Modified Health Assessment Questionnaire (MHAQ)|Modified Health Assessment Questionnaire (MHAQ) 0-8 with 8 being the most activity|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||MHAQ units on a scale||Standard Error|Mean
2716666|NCT01123356|Secondary|Frequency of Adverse Events|Number of adverse events occuring in greater than 20% of subjects|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.|||events|||Number
2716622|NCT01123655|Secondary|Patient Global Assessment (PGA) and Physician Global Assessment|Patient and Physician (PI) Assessments both range from 0-10 with 10 being the most disease activity|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||score on a scale||Standard Error|Mean
2716623|NCT01123655|Secondary|Laboratory Results of A12 vs Placebo Anti-CCP Antibody||0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||IU/mL||Standard Error|Mean
2716624|NCT01123655|Secondary|Sedimentation Rate|Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||mm/hr||Standard Error|Mean
2716625|NCT01123655|Secondary|Rheumatoid Factor|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||IU/mL||Standard Error|Mean
2716626|NCT01123655|Secondary|C-reactive Protein|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||mg/L||Standard Error|Mean
2716627|NCT01123655|Secondary|Total Protein, Albumin|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||g/dL||Standard Error|Mean
2716628|NCT01123655|Secondary|Sodium, Potassium and Chloride|Laboratory results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||mmol/L||Standard Error|Mean
2716629|NCT01123655|Secondary|Ca, BUN, Glucose,Creatinine, Total Bilirubin|Laboratory Results of A12 vs Placebo-CMP to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||mg/dl||Standard Error|Mean
2716630|NCT01123655|Secondary|AST, ALT and Alkaline Phosphatase|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||IU/L||Standard Error|Mean
2716631|NCT01123655|Secondary|Platelets|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||10^3 cells/uL||Standard Error|Mean
2716632|NCT01123655|Secondary|White Blood Count|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||10^3 cells/uL||Standard Error|Mean
2716633|NCT01123655|Secondary|Red Blood Cells|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||10^6 cells/uL||Standard Error|Mean
2716634|NCT01123655|Secondary|Hemaglobin|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|Baseline and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||grams/deciliter||Standard Error|Mean
2716635|NCT01123655|Secondary|Red Blood Cell Distribution Width (RDW)|Laboratory Results of A12 vs Placebo RDW is a measure of the range of variation of red blood cell volume reported as part of a standard blood count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0 and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||percent of mean corpuscular volume||Standard Error|Mean
2716636|NCT01123655|Secondary|Laboratory Results of A12 vs Placebo-Total Immunoglobulin (Immature Granulocytes)|Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|Baseline and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||grams per deciliter||Standard Error|Mean
2716637|NCT01123655|Secondary|Hematocrit|Laboratory Results of A12 vs Placebo to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||ratio of RBC to total blood cells/volume||Standard Error|Mean
2716638|NCT01123655|Secondary|Laboratory Results of A12 vs Placebo: Basophils|Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|Baseline and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||percent in total white blood cells/ml||Standard Error|Mean
2717681|NCT01118273|Secondary|Karolinska Sleep Diary - Sleep Quality|Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2716639|NCT01123655|Secondary|Laboratory Results of A12 vs Placebo: Lymphocytes|Measure to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|0-16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||percent in total white blood cells/ml||Standard Error|Mean
2716640|NCT01123655|Secondary|Eosinophils|Laboratory Results of A12 treated vs Placebo of Eosinophils to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|Baseline and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||percent in total white blood cells||Standard Error|Mean
2716641|NCT01123655|Secondary|A12 Treated vs Placebo of Monocytes.|Laboratory Results of A12 treated vs Placebo of Monocytes to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|Baseline and 16 wks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||percent of total white blood cells||Standard Error|Mean
2716642|NCT01123655|Secondary|Neutrophils Counts at 0 and 16 Weeks|Laboratory Results of A12 vs Placebo:Complete blood count Neutrophil count to determine whether APL has any effect on routine blood counts, chemistries, electrolytes, immunoglobulin to measure potential toxicities|Baseline and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||percent of total number of blood cells||Standard Error|Mean
2716643|NCT01123655|Secondary|Change in IgG and IgA Immunoglobulin From Baseline to 8 or 16 Weeks|The change was computed between baseline and 8 or 16 weeks, whichever was available.|baseline and 8 or 16 wks|Some participants only had measurable data at 8 weeks, or dropped out before 16 weeks.|||absolute change (followup-baseline) ng/m||Standard Deviation|Mean
2716644|NCT01123655|Secondary|Change in Cytokine Profile From Baseline and 16 Weeks|Cytokines assessed are IL-10, IL-13, IL-5, IL-1B, IL-9, IL-17A, IL-6, IL-21, TGF-B, TNFa,and MIP3A.|0 and 16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||absolute change (picograms/milliliter)||Standard Deviation|Mean
2716645|NCT01123655|Secondary|Clinical Disease Activity Index (CDAI) at 0 and 16 Weeks Follow up|Interpretation of Clinical Disease Activity Index (CDAI) scores < 2.8 indicate remission; >2.8 and <= 10 indicates low disease activity; >10 and <= 22 indicates moderate disease activity; >22 indicates high disease activity.|0 and16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||disease activity score||Full Range|Mean
2716646|NCT01123655|Secondary|Flow Cytometry|Change in Percentage of CD4+CD25+FoxP3 T regulatory cells, CD4+IL-10+ cells, CD4+ IL-4+ cells, CD4+IL17+ cells. Some patients had only had enough blood collected at 8 weeks or 16 weeks or dropped out after 8 weeks, and we used/combined what was available.|baseline and 8 or 16 weeks|Not all participants had data available for all measurements.|||percent change in number of cells||Standard Deviation|Mean
2716647|NCT01123655|Primary|Number and Percent of Participants With Reduction of Immunity to Collagen Type-II After APLA-12 Treatment.|The primary outcome variable is the presence of a > 25% reduction in net IFN concentration in supernatants of 1(II)-stimulated PBMC cultures from baseline after 16 weeks of treatment.|16 weeks|We could not analyze all the patients due to adverse events, drop outs or not all participants had data available for all measurements|||Participants|||Count of Participants
2716648|NCT01123642|Secondary|Clinician Administered PTSD Scale (CAPS-5)|Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).|one year|Sample sizes differ across time points due to attrition and missing data.|||score on a scale||Standard Deviation|Mean
2716649|NCT01123642|Secondary|Quality of Life Scale (QLS)|Quality of life measure of functioning scored on a 1 (delighted) to 7 (terrible) scale. Scores are summed with higher scores indicating lower quality of life. Total scores range from 16 - 112.|one year|Sample sizes differ due to attrition and missing data.|||score on a scale||Standard Deviation|Mean
2716650|NCT01123642|Secondary|Inventory of Psychosocial Functioning (IPF)|"80-item self-report measure of psychosocial functioning across multiple domains (e.g., family, social, day-to-day activities). Items are rated on a 7-point scale ranging from 0 (never) to 6 (always). Lower scores indicate more positive outcomes."|one year|Sample sizes differ due to attrition and missing data.|||score on a scale||Standard Deviation|Mean
2716651|NCT01123642|Primary|World Health Organization Disability Assessment Schedule II (WHODAS II)|Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.|one year|A total of 345 participants were enrolled, of which 309 were deemed eligible. Analyses are conducted with the total sample N = 309, followed over time. Sample sizes vary over time due to attrition and missing data.|||units on a scale||Standard Deviation|Mean
2716652|NCT01123512|Primary|Proportion of Participants With Study Success|"Patient success will be defined as:~Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),~Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and~Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation"|12 Month Post-op||||participants|||Number
2716653|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
2716654|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
2716655|NCT01123395|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.|||ng/mL||Standard Deviation|Mean
2716656|NCT01123382|Secondary|Delay in Termination of Shoulder Abduction EMG Activity|Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials. Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart. The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction. Delay of termination (DOT) was defined as the duration between cessation of the audible tone and return of the EMG signal to baseline. Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation, and return to steady for delay of termination. The mean DOT of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOT were used as summary metrics.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||ratio of affected to unaffected arm||Standard Error|Least Squares Mean
2716657|NCT01123382|Secondary|Delay in Initiation of Shoulder Abduction EMG Activity|Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials. Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart. The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction. Delay of initiation (DOI) was defined as the duration between onset of the audibe tone and the onset of EMG signal. Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation. The mean DOI of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOI were used as summary metrics.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||ratio of affected to unaffected arm||Standard Error|Least Squares Mean
2716658|NCT01123382|Secondary|Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected|A measure of isometric strength in response to audio cue. Isometric shoulder abduction moment was measured with a Biodex Biomechanical Measurement System (Biodex Medical Systems, Shirley, NY). The average moment during the last second of the audible tone was calculated for each trial and those values were averaged over the three trials. Subjects underwent testing of both shoulders, non-paretic side first, and the results are presented as the ratio of the paretic shoulder to the non-paretic shoulder to decrease the influence of intra-subject variability between measurements.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||ratio of affected to unaffected arm||Standard Error|Least Squares Mean
2716659|NCT01123382|Secondary|Pain Interference Questionnaire|BPI-9 from Brief Pain Inventory, Short Form. Pain interference is on a 0 - 10 scale, with 0 being no interference, and 10 being complete interference.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2716660|NCT01123382|Secondary|Fugl-Myer Motor Assessment (FMA) - Upper Extremity|The Fugl-Myer Motor Assessment (FMA) is a motor recovery measure. Volitional movement of the upper limb (shoulder, elbow, forearm, wrist, and hand) is examined in and out of synergies. Each item was graded on a 3-point ordinal scale and summed to provide a maximum score of 66, with higher scores indicating lower impairment.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2716661|NCT01123382|Secondary|Pain-free External ROM, Degrees|Passive pain-free Externa ROM is a motor recovery measure. The subject was supine with the shoulder adducted with hand resting on the abdomen, elbow flexed, and with the humerus supported by the mat. The axis of a universal goniometer was centered on the olecranon process of the ulna projecting through the humeral shaft toward the humeral head. The subject's shoulder was externally rotated passively to the pain threshold, defined as the start of any pain. Pain at rest was recorded as 0 degrees.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||degrees||Standard Error|Least Squares Mean
2716662|NCT01123382|Secondary|SF-36 Bodily Pain Component|The SF-36v2 is a population-norm based health related quality of life measure, presented in T-scores where population average equals a score of 50 with a standard deviation of 10. Maximum is 100, with higher score indicating greater health realated quality of life.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2716663|NCT01123382|Secondary|ShoulderQ VGRS Scale|The ShoulderQ Visual Graphics Rating Scale (VGRS) T is a structured questionnaire designed to assess severity of HSP at rest during the day, on movement, and at night on a 0-30 scale where higher numbers indicate greater pain.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2716664|NCT01123382|Primary|Brief Pain Inventory Short Form|The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
2716667|NCT01123356|Secondary|Biomarkers Changes During Treatment.|Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.|30 Weeks|The biomarker sub-study was not completed due to poor accrual to this substudy and lack of feasibility.||||||
2716668|NCT01123356|Secondary|Frequency of Adverse and Severe Adverse Events|Frequency of adverse and severe adverse events|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.|||participants|||Number
2716669|NCT01123356|Primary|Overall Response Rate|"Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).~Overall response rate was defined as those who experienced a response of CR, CRi or PR."|30 Weeks|Overall response rate is defined as response (CR, CRi or PR) at cycle 3 or cycle 6 evaluation. Only patients who completed at least 3 cycles were eligible for analysis for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2716670|NCT01123200|Secondary|Changes in Accuracy of BCI for Controlling Devices and Text|Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period.|6 months, 12 months, 18 months|The first six month period was not completed by any participant so accuracy data for six months could not be analyzed.||||||
2716671|NCT01123200|Primary|Duration of BCI Usage by Persons With ALS.|Number of months of BCI usage by each participant.|Monthly measurements for a period of up to 18 months.||||months||Full Range|Mean
2716672|NCT01123161|Secondary|NIHSS Scores at 90 Days|The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.|90 days|Intention to treat patients with an available 90-day NIHSS values therefore the total numbers available are fewer than the total ITT population.|||units on a scale||Standard Deviation|Mean
2716673|NCT01123161|Secondary|The Barthel Index Measure of Activities of Daily Living;|The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.|90 days|The intention to treat population with a 90-day Barthel index available was used, therefore the numbers are fewer than in the total population.|||participants|||Number
2716674|NCT01123161|Primary|90 Day Mortality|Mortality prior to the 90-day evaluation.|90 days|ITT population|||participants|||Number
2716675|NCT01123161|Primary|Incidence of Pneumonia|Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness|7 days or discharge whichever comes first|ITT population|||participants|||Number
2716676|NCT01123161|Primary|Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset|Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.|48 hours|ITT patients in whom a brain image was obtained 36 yo 48 hours after treatment|||participants|||Number
2716677|NCT01123161|Primary|Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset|Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.|48 hours|Intention to treat patients with imaging obtained 36 to 48 hours after treatment|||participants|||Number
2716678|NCT01123161|Primary|The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.|Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability|90 days|Intention to Treat Population|||participants|||Number
2716679|NCT01123148|Primary|The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.|"Subjects will participate in 3 sessions. During each session each subject will copy a word in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days."|3 1-2 hour sessions over 2-4 weeks||||% Accuracy of selections||Standard Deviation|Mean
2716680|NCT01123083|Secondary|Composite Rank Sum: C-Peptide AUC, HbA1c and Exogenous Insulin Use at 6 and 12 Months|O'Brien analyses was performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily insulin use in the otelixizumab group compared with the placebo group at Months 6 and 12. The three variables was adjusted for Baseline values. Baseline adjustment was used to reduce the potential impact of imbalances in Baseline levels between treatment groups on the treatment comparisons at later time points. HbA1c and insulin use was ranked from smallest to largest, and C-peptide AUC was ranked from largest to smallest. If otelixizumab treatment was effective on the composite endpoint, then the mean of the ranks sum in the otelixizumab group was smaller than the mean of the ranks sum in the placebo group.|Month 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Rank||Standard Deviation|Mean
2716681|NCT01123083|Secondary|Composite Rank Sum: HbA1c and Exogenous Insulin Use at 6 and 12 Months|O'Brien mean rank analyses was performed on a two-part composite of the Baseline-adjusted HbA1c level and the Baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6 and 12. Baseline adjustment was used to reduce the potential impact of imbalances in Baseline levels between treatment groups on the treatment comparisons at later time points. For the O'Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) and adjusted mean daily insulin use values was ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks. If otelixizumab treatment was effective on this composite endpoint, then the mean of the ranks sum in the otelixizumab group was smaller than the mean of the ranks sum in the placebo group.|Month 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Rank||Standard Deviation|Mean
2716682|NCT01123083|Secondary|Percentage of Participants With Change From Baseline in Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events at Month 12|Severe hypoglycemia was considered as an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was considered as an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration less than or equal to 70 mg/dL and it was collected in (1) eCRF using two forms - for single event and for mutiple events, and (2) the IVRS system. The percentage of participant with incidence of severe hypoglycemia and documented symptomatic hypoglycemia have been reported.|Baseline (Day 1) and Month 12|ITT population.|||Percentage of participants|||Number
2716683|NCT01123083|Secondary|Average Number of Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events From Baseline to Month 12|Severe hypoglycemia was considered as an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was considered as an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration less than or equal to 70 mg/dL and it was collected in (1) eCRF using two forms - for single event and for mutiple events, and (2) the IVRS system. The numbers of participant-reported hypoglycemic events per participant of severe hypoglycemia and documented symptomatic hypoglycemia have been reported.|Baseline (Day 1) and Month 12|ITT population.|||Events|||Number
2716684|NCT01123083|Secondary|Change From Baseline in HbA1c Levels Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment|HbA1c level was recorded at Baseline, Month 3, 6 and 12. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Month 3, 6, 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2716685|NCT01123083|Secondary|Change From Baseline in Mean Daily Insulin Use Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment|Mean daily insulin use over 7 consecutive days during the 2 weeks preceding each key visit was calculated as the mean of the values of amount of insulin used per day on each of the 7 consecutive days. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Month 3, 6, 12|ITT population. Only those participants available at the indicated time points were analyzed.|||International unit per kilogram (IU/kg)||Standard Error|Least Squares Mean
2716686|NCT01123083|Secondary|Number of Participants With Responder Status|A participant was considered a responder when, at the given time point, the participant had: glycosylated hemoglobin (HbA1c) less than or equal to 6.5 percent and mean daily insulin use less than 0.5 international unit per kilogram per day (IU/kg/day) over 7 consecutive days during the 2 weeks preceding the visit.|Month 3, 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2716687|NCT01123083|Secondary|Change From Baseline in Stimulated C-Peptide Mean AUC at Week 12, Month 6, 12 and 18|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg/dL and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Week 12, Month 6, 12, 18|ITT population. Only those participants available at the indicated time points were analyzed.|||nanomoles per liter||Standard Deviation|Mean
2716688|NCT01123083|Secondary|Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide AUC (Normalized for 120-minute Time Interval) at Week 12 and 6 Months|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg/dL and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Week 12, Month 6|ITT population. Only those participants available at the indicated time points were analyzed.|||nanomoles per liter||Standard Error|Least Squares Mean
2716689|NCT01123083|Primary|Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide Area Under Curve (AUC) (Normalized for 120-minute Time Interval) at Month 12|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg per deciliter (mg/dL) and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the value at Month 12 from the Baseline value.|Baseline (Day 1) and Month 12|ITT population consisted of all participants who were randomized and received any part of at least 1 infusion of study drug. Only those participants available at the indicated time points were analyzed.|||nanomoles per liter||Standard Error|Least Squares Mean
2716690|NCT01122927|Secondary|Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)|The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6 to 17. It was adapted from the Adults Global Assessment Scale. The Global Assessment Scale was a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS Score (range 1 to 100) is a single-item score for rating a child's general level of functioning on a health-illness continuum, with higher scores representing better functioning.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716691|NCT01122927|Secondary|Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score|The ADHD-RS-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale was linked directly to DSM-IV-TR diagnostic criteria for ADHD. There were 3 versions of the scale: a parent questionnaire on home behaviors (English), a parent questionnaire on home behaviors (Spanish), and a teacher questionnaire on classroom behaviors. For this trial, the parent questionnaire on home behaviors (English) was utilized. The ADHD-RS-IV Total Score (range 0 to 54) is the sum of rating scores for 18 items, with higher scores representing greater severity. A missing value for any ADHD-RS-IV assessment items could have resulted in a missing ADHD-RS-IV Total Score. Data were only available for 82 participants with bipolar disorder and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716692|NCT01122927|Secondary|Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale|The GBI is a self-report inventory with 73 items focusing on mood-related behaviors, including depressive, hypomanic, and biphasic symptoms. For this trial, two 20-item subscales were utilized: one was completed by the parent/guardian or legal representative, as applicable for local laws, and the other was completed by the participant. Responses were given on a 4-point Likert scale, with 0 being never or hardly ever and 3 being very often or almost constantly. The GBI Total Score for mania (range 0 to 30) is the sum of scores for items 1 to 10 and the GBI Total Score for depression (range 0 to 30) is the sum of scores for items 11 to 20 in the GBI Parent/Guardian or Subject Version panel. Scores from the Parent/Guardian and participant Versions were summarized separately. A missing value for any GBI assessment items could have resulted in a missing GBI Total Score. High scores represent greater psychopathology. Data was only available for 80 de novo participants with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716693|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716694|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Data for 94 de novo participants were available with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716757|NCT01122680|Secondary|Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point|FEF 25-75% is the mean forced expiratory flow between 25% and 75% of the FVC determined at the end of the 4-week treatment period. This is often referred to as the maximum midexpiratory flow. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEF data|||Litre||Standard Error|Least Squares Mean
2716695|NCT01122927|Secondary|Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score|The YMRS consists of 11 items assessing the core symptoms of mania and was used to assess participants with bipolar I disorder, manic and mixed episodes with or without psychotic features: elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech (rate and amount), language - thought disorder, content, disruptive - aggressive behavior, appearance, and insight. Each item had 5 or 9 grades of severity, with lower scores indicating milder symptoms. The number of raters within each trial center was to be kept to a minimum. The YMRS Total Score (range 0 to 44) is the sum of the rating scores for 11 items for assessing the core symptoms of mania. A missing value for any YMRS assessment item(s) could have resulted in a missing YMRS Total Score. A higher YMRS Total Score represents greater severity. In this study, 94 participants had bipolar disorder, this explains the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716696|NCT01122927|Secondary|Mean Change in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716697|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716698|NCT01122927|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716699|NCT01122927|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716700|NCT01122927|Secondary|Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716701|NCT01122927|Secondary|Percentage of Participants Who Discontinued Due to All Adverse Events|The percentage of participants who discontinued due to all causes other than sponsor terminating the trial was measured from the date of entering the open-label treatment phase to the date of ET for discontinued participants in the open-label treatment phase (ie, time to discontinuation = date of discontinuation [or date of completion for completed participants] − date of participant entering the open-label treatment phase + 1). If the participants completed the trial or were discontinued due to the sponsor terminating the trial, they were censored at the time of completion or trial termination, respectively.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||percentage of participants|||Number
2716702|NCT01122927|Secondary|Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The below reported N value is the number of participants with specified suicidal ideation/behavior at the given time point.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
2716703|NCT01122927|Secondary|Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716704|NCT01122927|Secondary|Baseline and Post-Baseline Tanner Staging|Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below.|Baseline to Last Visit|All those participants who had received at least one dose of oral aripiprazole during the open-label treatment phase.|||participants|||Number
2716705|NCT01122927|Secondary|Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)|The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use [CHMP] and the Paediatric Sub-Committee of the European Medicinal Agency [PDCO]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
2716706|NCT01122927|Secondary|Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score|The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716707|NCT01122927|Secondary|Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716708|NCT01122927|Secondary|Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
2716709|NCT01122927|Secondary|Incidence of Vital Signs of Potential Clinical Relevance|Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
2716710|NCT01122927|Secondary|Incidence of Physical Examination Findings of Potential Clinical Relevance|The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole. Any clinically relevant abnormal changes were recorded as TEAEs.|||participants|||Number
2716711|NCT01122927|Secondary|Incidence of Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
2716712|NCT01122927|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.|All participants who had received at least one dose of oral aripiprazole.|||Participants|||Number
2716713|NCT01122901|Secondary|Progression Free Survival|Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: >25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increasing doses of corticosteroids. and/or b) Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared to BL scan or best response following initiation of therapy c) Any new lesion. d) Clear clinical deterioration not attributable to other causes apart from the tumor e) Failure to return for evaluation due to death or deteriorating condition.|2 years||||months||95% Confidence Interval|Median
2716714|NCT01122901|Secondary|Tumor Propagation (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At the time of surgery|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug.||||||
2716715|NCT01122901|Secondary|Expression Levels of Notch Pathway Components and Downstream (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At the time of surgery|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug.||||||
2716716|NCT01122901|Secondary|Overall Survival|"time to event endpoints for Group A will be measured from date of first dose. All patients who receive at least one dose will be included in analysis.~Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment)."|2 years||||months||95% Confidence Interval|Median
2716717|NCT01122901|Secondary|Number of Participants With Toxicities Associated With Study Drug (Group A and Group B)|assessed by the National Cancer Institute CTCAE version 4.0 assessed if patient received at least one dose of study drug Grade 3-5 toxicities grade 3 -severe grade 4 - life threatening grade 5 - death|Up to 30 days after completion of study treatment||||Participants|||Count of Participants
2716718|NCT01122901|Secondary|Radiographic Response Rate According to the Radiographic Assessment in Neuro-Oncology Criteria (Group A) and Group (B)|"RANO:~Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|Up to 6 months after completion of treatment||||Participants|||Count of Participants
2716719|NCT01122901|Primary|Efficiency of Neurosphere Generation After Pretreatment With RO4929097 (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At time of surgery|This outcome could not be analyzed as the n was too small. Only had 7 samples. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug||||||
2716720|NCT01122901|Primary|Overall Median Progression-free Survival (6-month PFS)|Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: >25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increasing doses of corticosteroids. and/or b) Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared to BL scan or best response following initiation of therapy c) Any new lesion. d) Clear clinical deterioration not attributable to other causes apart from the tumor e) Failure to return for evaluation due to death or deteriorating condition.|At 6 months||||months||95% Confidence Interval|Median
2716721|NCT01122862|Secondary|Interproximal Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
2716758|NCT01122680|Secondary|FVC Individual Measurements at Each Time-point|"Individual FVC measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
2716722|NCT01122862|Secondary|Interproximal Plaque Index After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
2716723|NCT01122862|Secondary|Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
2716724|NCT01122862|Secondary|Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
2716725|NCT01122862|Primary|Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|Intention to Treat (ITT) population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
2716726|NCT01122849|Secondary|Number of Participants Showing Improvement for VAS Scale Daily Diary Questions|Participants were asked following daily diary VAS scale questions a) How easy it was to breathe through your nose and b) How open their nose feels at this time. Both of these questions were scored using 100 mm VAS scale where, 0=extremely difficult, 100=extremely easy.|on first night (Night 1) of each daily diary question|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2716727|NCT01122849|Secondary|Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4)|Participants were asked Q2 (How stuffed does your nose feel at this time?) and Q4 (How Breathing felt after the nasal strip was applied) of daily diary questions. Q2 was scored on 4 point scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms and Q4 on 11 point scale where -5=much worse, 0=same, 5=much better.|on first night (Night 1) of each daily diary question|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2716728|NCT01122849|Secondary|Number of Participants Showing Improvement for Sleep Problems and Symptoms on Waking in the Morning Domain of the NRQLQ|Participants scored all two domains of NRQLQ using same 7 points scale: 0=Not troubled, 1=Hardly troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Domains were Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score), and Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up); Lower scores indicate improvement in the rhinitis symptoms.|At Day 7 and Day 14||||Participants|||Count of Participants
2716738|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score ona scale||Standard Deviation|Mean
2716729|NCT01122849|Secondary|Change From Baseline in Mean Average Score of NRQLQ for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7 and Day 14 in Participants With the Risk of Sleep Apnea.|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Day 7 and at Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716730|NCT01122849|Secondary|Summary of Daily Diary Questions at Bed Time (After Strip Application) and in Morning (After Strip Removal).|Participants were asked how breathing felt after nasal strip was applied at bed time and removed in morning. The participants scored their responses on the scale of -5 to 5 where -5 = much worse, 0 = same and 5= much better. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716731|NCT01122849|Secondary|Summary of Daily Dairy Questions Before and After Strip Removal in Morning|Participants were asked how stuffed their nose felt before and after strip removal in morning. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily.|At Day 1, Day 2, day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716732|NCT01122849|Secondary|Summary of Daily Diary Questions Before and After Strip Application at Bedtime|Participants were asked how stuffed their nose felt before and after strip application at bed time. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment|||Score on a scale||Standard Deviation|Mean
2716733|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning.|Participants were asked how open their nose feels before and after strip removal in morning. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
2716734|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime|Participants were asked how open their nose feels before and after strip application at bedtime. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
2716735|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning|Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716736|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime|Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment|||Score on a scale||Standard Deviation|Mean
2716737|NCT01122849|Secondary|Summary for Other Questions of PIRS Questionnaire|The following questions were asked from Section A (Q1 to Q12; 2 Not getting enough sleep, 4 Poor alertness during the daytime, 5 Difficulty keeping your thoughts focused, 6 Others noticing you appeared tired or fatigued, 7 too many difficulties to overcome, 8 Bad moods because you had poor sleep, 9 Lack of energy because of poor sleep, 10 Poor sleep that interferes with your relationships, 11 Being unable to sleep, 12 Being able to do only enough to get by, Section B (Q13 to Q16; 13 From the time you tried to go to sleep, How long did it take to fall asleep on most nights, 14 If you woke during the night, how long did it take to fall back to sleep on most nights,15 Not counting times when you were awake in bed, how many hours of actual sleep did you get during the worst night, 16 On how many days did you have trouble coping because of poor sleep and Section C (Q17 to Q20;, 19 The regularity of your sleep, 20 The soundness of your sleep)|At Day 7 and Day 14||||Score on a Scale||Standard Deviation|Mean
2716854|NCT01122160|Primary|Gastric pH||1 hour prior to gastric emptying on Day 7 of the given intervention||||pH||Standard Deviation|Mean
2716739|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better. (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716740|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2, the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for question 4.)|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716741|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for Q4.)|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
2716742|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14.|Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0=extremely difficult to breathe and 100=extremely easy|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716743|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7|Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
2716744|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14|Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2716745|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7|Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on scale||Standard Deviation|Mean
2716746|NCT01122849|Primary|Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14|Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lowe CQ7 scores reflect better nasal patency.|At Baseline and Day 14||||Score on a Scale||95% Confidence Interval|Least Squares Mean
2716754|NCT01122680|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Day|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing data for rescue medication|||Puffs/day||Standard Error|Least Squares Mean
2716755|NCT01122680|Secondary|Mean Evening PEF Response|Mean evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing evening PEF data|||Litre/min||Standard Error|Least Squares Mean
2716756|NCT01122680|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing morning PEF data|||Litre/min||Standard Error|Least Squares Mean
2716747|NCT01122849|Primary|Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7|Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lower CQ7 scores reflect better nasal patency.|At Baseline and Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2716748|NCT01122849|Primary|Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 14|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2716749|NCT01122849|Primary|Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2716750|NCT01122849|Primary|Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14|Participant were asked questions related to their sleep using PIRS questionnaire. The PIRS questionnaire had 3 sections. Section A (Q1 to Q12), Section B (Q13 to Q16) and Section C (Q17 to Q20). Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B questions 13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Questions 15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.|At Baseline and Day 14|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2716751|NCT01122849|Primary|Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7|The PIRS questionnaire had 3 sections (Section A [Q1 to Q12], Section B [Q13 to 16] and Section C [Q17 to Q20]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B, Q13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Q15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.|At Baseline and Day 7|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2716752|NCT01122680|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and last week of treatment (week 4)|FAS with non-missing data for nighttime awakenings|||Night awakenings per week||Standard Error|Least Squares Mean
2716753|NCT01122680|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of a seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with non-missing ACQ data|||Units on a scale||Standard Error|Least Squares Mean
2716759|NCT01122680|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
2716760|NCT01122680|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
2716761|NCT01122680|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
2716762|NCT01122680|Secondary|FEV1 Individual Measurements Response at Each Time-point|"Individual FEV1 measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
2716763|NCT01122680|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
2716764|NCT01122680|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
2716765|NCT01122680|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period. This patient set is therefore FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
2716766|NCT01122576|Secondary|Best-corrected Distance Visual Acuity|High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set|||logMAR|Participants|Standard Deviation|Mean
2716767|NCT01122576|Secondary|Uncorrected Distance Visual Acuity|High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set|||logMAR|Participants|Standard Deviation|Mean
2716768|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 4 (4-6 Months)|Full Analysis Set|||Diopters|Participants|Standard Deviation|Mean
2716769|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 3 (2-3 Months)|Full Analysis Set|||Diopters|Participants|Standard Deviation|Mean
2716770|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2716771|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2716772|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set|||units on a scale|Participants|Standard Deviation|Mean
2716773|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set|||units on a scale|Participants|Standard Deviation|Mean
2716774|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 4 (4-6 months)||||units on a scale|Participants|Standard Deviation|Mean
2716775|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 3 (2-3 months)|Full Analysis Set|||units on a scale|Participants|Standard Deviation|Mean
2716776|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716777|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716778|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716779|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716780|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716781|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716782|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716783|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716784|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716785|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716786|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716787|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716788|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716789|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716790|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716791|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716792|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716793|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716794|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716795|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716796|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716797|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716798|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716799|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
2716800|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full set analysis|||log contrast sensitivity units||Standard Deviation|Mean
2716801|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716802|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716803|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716804|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716805|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716806|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716807|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716808|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716809|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
2716810|NCT01122511|Secondary|Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
2716811|NCT01122511|Secondary|Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
2716812|NCT01122511|Secondary|The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
2716813|NCT01122511|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
2716814|NCT01122446|Secondary|First-phase Insulin Response From IvGTT Over Time|As secondary variables of effect we will measure the change in first-phase insulin response. In all children a baseline IvGTT is performed and after that annual IvGTT´s are performed within the study. First phase insulin response is calculated from insulin 1 and 3 minutes after the given glucose solution. Insulin is measured by Laboratory of Clinical Chemistry at Skåne University Hospital, Malmö. Change in first phase insulin response will be calculated for each individual and compared between the groups.|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. Some data missing|||nmol/L||Standard Deviation|Mean
2716815|NCT01122446|Secondary|HbA1c|At all visits in the study HbA1c is measured. The change in HbA1c from baseline HbA1c is analysed at Laboratory of Clinical Chemistry, Skåne University Hospital, Malmö|During 5 year follow-up|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. Some data missing|||mmol/mol||Standard Deviation|Mean
2716816|NCT01122446|Secondary|AUC C-peptide From OGTT Over Time|OGTT is performed at baseline, after 6 months and thereafter annually|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.|||nmol*min/L||Standard Deviation|Mean
2716817|NCT01122446|Secondary|120 Min C-peptide on OGTT Over Time|OGTT is performed at baseline, after 6 months and thereafter annually|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. 120 min C-peptide missing at some endpoints due to missed sample|||nmol//L||Standard Deviation|Mean
2716818|NCT01122446|Secondary|Fasting C-peptide Over Time|Fasting C-peptide is performed at baseline and thereafter every 6 months|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. At 42 months one value is missing due to missed sampling.|||nmol/L||Standard Deviation|Mean
2716819|NCT01122446|Secondary|AUC Glucose From OGTT Over Time|OGTT is performed at baseline, after 6 months and thereafter annually.|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up. One child did not do OGTT at baseline and therefore the placebo group only contains 24 participants in this analysis. At 42 months one additional child only did 2 point OGTT.|||mmol*min/L||Standard Deviation|Mean
2716820|NCT01122446|Secondary|120 Minutes Glucose From OGTT Over Time|OGTT is performed at baseline, after 6 months and thereafter annually. Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.|||mmol//L||Standard Deviation|Mean
2716821|NCT01122446|Secondary|Fasting Glucose Over Time|Fasting glucose is measured at baseline and every 6 months within the study. Glucose is analysed by Hemocue.|During 5 year follow-up from treatment|Children meeting the primary endpoint type 1 diabetes are not included in the analysis - therefore the number of analysed children drops during follow-up.|||mmol/L||Standard Deviation|Mean
2716822|NCT01122446|Secondary|Number of Participants With Type 1 Diabetes|Onset of Type 1 diabetes, defined according to ADA criteria, by treatment|During 5 years follow up from treatment|Number of participants developing diabetes during 5 year follow up in each group|||Participants|||Count of Participants
2716823|NCT01122446|Primary|Adverse Events|Adverse events, serious adverse events, hematology, chemistry, autoantibody titles by treatment group|During 5 years follow up from treatment||||Serious adverse events|||Number
2716824|NCT01122394|Secondary|Antihypertensive/ Lipid-lowering Medication Adherence|Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent|6 months|One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis|||units on a scale||Standard Deviation|Mean
2716825|NCT01122394|Secondary|Exercise Adherence|Measured by 7-day Physical Activity Recall|6 months||||hours per week of cardio||Inter-Quartile Range|Median
2716826|NCT01122394|Secondary|Total Cholesterol/High Density Lipoprotein Ratio||6 months|Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis|||ratio||Inter-Quartile Range|Median
2716827|NCT01122394|Secondary|Dietary Sodium|self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)|6 months||||participants|||Number
2716828|NCT01122394|Primary|Systolic Blood Pressure||6 months|restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment|||mm Hg||Inter-Quartile Range|Median
2716829|NCT01122381|Primary|Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.|"Compare number of migraine headache days pre and post treatment between the ESX and placebo group.~Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels."|4 weeks, end of treatment and pre-treatment baseline|||||||
2716830|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Overall Relationship domain consists of 2 items (items 13-14), each rated on a scale of 1 (Never) to 5 (Always). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Overall Relationship observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2716831|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Self-Esteem domain consists of 4 items (items 9-12), each rated on a scale of 1 (Never) to 5 (Always). Item 11 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Self-Esteem observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2716832|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Confidence domain measures improvement in confidence; 2 subscales (6 items: Self-Esteem [items 9-12]; Overall Relationship [items 13-14]). Each item range: 1 (Never) to 5 (Always); item 11 reverse scored. Domain score=sum of domain's respective items, then transformed into 0 (least favorable) to 100 (most favorable) scale. Transformed score=100x[(actual raw score-lowest possible raw score)/possible raw score range]. Least Squares Mean change adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Confidence observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2716833|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. Transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Sexual Relationship observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2716907|NCT01121913|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).~Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||ng*h/mL||Standard Deviation|Mean
2716834|NCT01122264|Secondary|Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)|The PAIRS is a 23-item scale that assesses broader psychological/interpersonal outcomes associated with erectile dysfunction and its treatment. Each question is rated on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The scale consists of 3 domains: Sexual Self-Confidence (items 1-6), Spontaneity domain (items 7-15), and Time Concerns (items 16-23). The average domain score for each domain was calculated by adding the nonmissing items for the respective domain, then dividing by the number of nonmissing items for the respective domain. Each average domain score ranged from 1 to 4. Higher scores represent the following: greater sexual self-confidence (better outcome); greater spontaneity (better outcome); higher time concerns (worse outcome). The Least Squares Mean changes were adjusted for treatment group, country, baseline IIEF-EF severity, baseline domain score, and baseline domain score*treatment (if p<0.10).|Baseline, 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline PAIRS observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2716835|NCT01122264|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks|The participant questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score was obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), then multiplying by 25, thus obtaining a score range from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). Least Squares Mean changes were adjusted for treatment group, country, visit, and visit*treatment.|4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline EDITS observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2716836|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction on the IIEF over past 4 weeks and consists of 2 questions (items 13 and 14), each rated on a scale from 1 (very dissatisfied) to 5 (very satisfied). Total scores range from 2 to 10; lower numerical scores represent lower overall satisfaction. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Overall Satisfaction observation.|||units on a scale||Standard Error|Least Squares Mean
2716837|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction score over past 4 weeks (1 intercourse attempt item, 2 intercourse satisfaction items). Each item range: 0 (no intercourse attempts/no satisfaction) to 5 (more attempts/high satisfaction). Total scores range: 0-15; lower scores=lower intercourse satisfaction. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Intercourse Satisfaction observation.|||units on a scale||Standard Error|Least Squares Mean
2716838|NCT01122264|Secondary|Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments|The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method.|8 weeks up to 334 days|The analysis included all randomly assigned participants who completed the 8-week randomized treatment.|||days||95% Confidence Interval|Median
2716839|NCT01122264|Secondary|Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment|The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.|Baseline through 24 weeks|The analysis included all randomly assigned participants.|||participants|||Number
2716840|NCT01122264|Secondary|Patterns of Erectile Dysfunction Treatment Change|Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.|Baseline through 24 weeks|All randomly assigned participants were included in the analysis.|||participants|||Number
2716841|NCT01122264|Secondary|Number of Treatment Switches|The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).|Baseline through 24 weeks|The analysis included all randomly assigned participants who switched erectile dysfunction medication and had a baseline and post-baseline observation.|||number of treatment switches||Standard Deviation|Mean
2716842|NCT01122264|Secondary|Global Assessment Questions (GAQ)|The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?|24 weeks|The analysis included all randomly assigned participants. The last available GAQ assessment for each participant was used in the analysis.|||participants|||Number
2716855|NCT01122108|Other Pre-specified|Weighted vs. Unweighted Composite BASA Scale Scores|Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4.|1 Day||||Units on a BASA Scale||Standard Deviation|Mean
2716843|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)|Participant-assessed diary. Has 5 questions (Question[Q]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEP observation.|||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
2716844|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Sexual Desire observation.|||units on a scale||Standard Error|Least Squares Mean
2716845|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Orgasmic Function observation.|||units on a scale||Standard Error|Least Squares Mean
2716846|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain|Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF-EF observation.|||units on a scale||Standard Error|Least Squares Mean
2716847|NCT01122264|Primary|Time to Discontinuation of Randomized Treatment|Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.|Baseline up to 334 days|The analysis included all randomly assigned participants.|||days||95% Confidence Interval|Median
2716848|NCT01122238|Primary|Percent Change in Cigarettes Smoked Per Day (CPD)|"Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model.~Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces average number of cigarettes per day in the past week (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar."|Assessed at week 26 relative to baseline CPD.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.|||Percent Change in cigarettes per day||Standard Deviation|Mean
2716849|NCT01122238|Secondary|Average Number of Cigarettes Per Day in the Past Week.||Assessed at baseline and week 26.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.|||Change in cigarettes per day||Standard Deviation|Mean
2716850|NCT01122173|Secondary|Chronic Safety-Incidence of Major Complications|Chronic safety is defined as the incidence of Major Complications during the period from 8 - 365 days following the initial ablation procedure (excluding pulmonary vein stenosis and atrio-esophageal fistula from 8 - 180 days, which are included in the primary safety endpoint). The incidence of pulmonary vein stenosis and atrioesophageal fistula is included during the period from 181 - 365 days.|8 - 365 days post-procedure||||Participants|||Count of Participants
2716851|NCT01122173|Secondary|Acute Procedural Success|Acute procedural success is defined as the successful ablation of at least three of four pulmonary veins as shown by pulmonary vein entrance block per vein during the initial ablation procedure. A subject is considered to be an acute procedural failure if acute procedural success cannot be obtained by using the Hansen system and, as a result, manual manipulation is needed to complete the ablation procedure with the ablation catheter.|Day 0||||Participants|||Count of Participants
2716852|NCT01122173|Primary|Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes|The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.|91 - 365 days after the inital ablation procedure||||Participants|||Count of Participants
2716853|NCT01122173|Primary|Safety-Incidence of Major Complications|The primary safety endpoint was defined as the incidence of major complications, including all early onset (within 7 days of the ablation procedure) major complications, and the incidence of esophageal injury or pulmonary vein stenosis through 180 days.|within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days||||Participants|||Count of Participants
2716856|NCT01122108|Primary|Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug.|The bile acid sequestrant acceptability (BASA) scale has 4 scoring categories: taste, texture, appearance, and mixability. Participants rank each category separately. The best possible score for each category is 5, and the worst possible score for each category is 1.|1 Day||||Units on BASA Scale||Standard Deviation|Mean
2716857|NCT01122030|Secondary|Apparent Elimination Half-life of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. The apparent elimination half-life was calculated using the formula t1/2,z = (ln2)/λZ|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||hours||Geometric Coefficient of Variation|Geometric Mean
2716858|NCT01122030|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. Area under the plasma concentration versus time curve from time zero to infinity, calculated using the formula: AUC0-inf = AUC0-t + Ct/λZ where Ct was the last measurable concentration and λZ was the apparent terminal elimination rate constant.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716859|NCT01122030|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantitation, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations (Linear Up/ Log Down).|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2716860|NCT01122030|Secondary|Time to Maximum Observed Plasma Concentration of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||hours||Full Range|Median
2716861|NCT01122030|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|The pharmacokinetic (PK) analysis population included all randomized participants who received study drug and had at least one post-dose PK assessment completed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716862|NCT01122030|Secondary|Percentage of Participants With Webster Opiate Withdrawal Scale (WOWS) Score > 8 at Any Time During the Study|The Webster Opiate Withdrawal Scale (WOWS) assessment consisted of 7 questions which rate the severity of opiate withdrawal symptoms, including sweating, sleep, bone or joint aches, runny nose or tearing, gastrointestinal upset, anxiety or irritability and gooseflesh skin. Each symptom was rated on a scale from 0 (not present/no issues) to 4 or 5 (severe). The total score was calculated by summing the 7 individual scores and ranged from 0 (no withdrawal symptoms) to 29 (worst symptoms).|The WOWS assessment was performed at Screening, Day 14, Day 15 at pre-dose , and 24 and 48 hours post-dose and at the Follow-up/End of Study visit (Day 24).|Safety population|||percentage of participants||95% Confidence Interval|Number
2716863|NCT01122030|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score > 8 at Any Time During the Study|The COWS assessment consisted of 11 questions which rated the severity of opiate withdrawal symptoms, including resting pulse rate, gastrointestinal upset, sweating, restlessness, pupil size, tremor, anxiety or irritability, bone or joint aches, gooseflesh skin, yawning, and runny nose or tearing. Each symptom was rated on a scale from 0 (not present) to 4 or 5 (most severe). The total score was calculated by summing the 11 individual scores and ranged from 0 (no withdrawal symptoms) to 48 (worst symptoms).|The COWS assessments were performed at Screening, on Day 14, Day 15 (pre-dose and 1, 2, 3, 4, 5, 6 and 8 hours post-dose, and at unscheduled times as signs or symptoms indicate), on Days 16 and 17, and on Day 24/End of Study.|Safety population|||percentage of participants||95% Confidence Interval|Number
2716864|NCT01122030|Secondary|Change From Baseline in Number of Rescue Medications Used Per Day|Baseline was defined as the average number of rescue medications used per day prior to receiving study drug (Day 1 to Day 15). The number of rescue medications used per day at 24 hours and 48 hours post-dose was calculated as the average number of rescue medications used per day from 0 to 24 hours and 0 to 48 hours post-dose, respectively.|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||rescue medications / day||Standard Deviation|Mean
2716865|NCT01122030|Secondary|Change From Baseline in the Number of Bowel Movements With No Straining Per Day|"Straining during BMs was graded using the following scale:~0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score = 0.~Baseline was defined as the average number of BMs without straining per day prior to receiving study drug (Day 1 to Day 15). The number of BMs without straining per day at 24 hours and 48 hours post-dose was calculated as the average number of BMs with no straining per day from 0 to 24 hours and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||bowel movements with no straining / day||Standard Deviation|Mean
2716902|NCT01121926|Primary|Bioequivalence Based on Cmax,ss|Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
2716925|NCT01121666|Secondary|Clinical Pregnancy Rate (Second Treatment Cycle)|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Population with a second treatment cycle|||Clinical pregnancies|||Number
2716866|NCT01122030|Secondary|Change From Baseline in Number of False Start Bowel Movements Per Day|"A false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted) based on the question In the past 24 hours, how many times did you try to have a bowel movement but were unsuccessful? Baseline was defined as the average number of false start BMs per day prior to receiving study drug (Day 1 to Day 15).~The number of false start BMs per day at 24 hours and 48 hours post-dose was calculated as is the average number of false start BMs per day from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||false start bowel movements / day||Standard Deviation|Mean
2716867|NCT01122030|Secondary|Change From Baseline in BM Consistency|"Consistency of BMs was measured using the Bristol Stool Scale, as follows:~1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.~Baseline was defined as the average consistency of BMs prior to receiving study drug (Day 1 to Day 15). BM consistency at 24 hours and 48 hours post-dose was calculated as the average scores from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
2716868|NCT01122030|Secondary|Change From Baseline in Abdominal Discomfort|"Participants were asked to rate their abdominal discomfort for the past 24 hours using the following scale:~0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average abdominal discomfort score prior to receiving study drug (Day 1 to Day 15). Abdominal discomfort at 24 hours and 48 hours post-dose was calculated as the mean score from 0 to 24 and 0 to 48 hours post-dose respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
2716869|NCT01122030|Secondary|Change From Baseline in Abdominal Bloating|"Participants were asked to rate their abdominal bloating for the past 24 hours using the following scale:~0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average abdominal bloating score prior to receiving study drug (Day 1 to Day 15). Abdominal bloating at 24 hours and 48 hours post-dose was calculated as the mean score from 0 to 24 and 0 to 48 hours post-dose respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
2716870|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Complete Bowel Movements Per Day|"A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question Did you have a feeling of complete emptying after the bowel movement? Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to 15). Forty-eight hours post-dose was calculated as the average number of CBMs per day from 0 to 48 hours post-dose."|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete bowel movements / day||Standard Deviation|Mean
2716871|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Complete Bowel Movements Per Day|"A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question Did you have a feeling of complete emptying after the bowel movement? Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to Day 15)."|Baseline and 24 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete bowel movements / day||Standard Deviation|Mean
2716872|NCT01122030|Secondary|Change From Baseline in Straining During Bowel Movements|"Straining during BMs was graded using the following scale: 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.~Baseline was defined as the average straining score of all BMs prior to receiving study drug (Day 1 to Day 15). The straining score at 24 and 48 hours post-dose was calculated as the average straining score from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point|||units on a scale||Standard Deviation|Mean
2716873|NCT01122030|Secondary|Time to First Complete Spontaneous Bowel Movement|The time to first CSBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant's first CSBM was counted as an event and the time to first CSBM after dosing was calculated from the date and time of first dosing until the date and time of first CSBM. Participants who dropped out or were lost to follow-up before the first CSBM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population|||hours||95% Confidence Interval|Median
2716874|NCT01122030|Secondary|Time to First Bowel Movement|The time to first BM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant's first BM was counted as an event and the time to first BM after dosing was calculated from the date and time of first dosing until the date and time of first BM. Participants who dropped out or were lost to follow-up before the first BM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population|||hours||95% Confidence Interval|Median
2716875|NCT01122030|Secondary|Time to First Spontaneous Bowel Movement|The time to first SBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant's first SBM was counted as an event and the time to first SBM after dosing was calculated from the date and time of first dosing until the date and time of first SBM. Participants who dropped out or were lost to follow-up before the first SBM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population|||hours||95% Confidence Interval|Median
2716876|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of having a feeling of complete emptying after the bowel movement).~Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of CSBMs per day from 0 to 48 hours post-dose."|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete spontaneous bowel movements/day||Standard Deviation|Mean
2716877|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of having a feeling of complete emptying after the bowel movement).~Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15)."|Baseline and 24 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete spontaneous bowel movements/day||Standard Deviation|Mean
2716878|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Bowel Movements Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of BMs per day from 0 to 48 hours post-dose.|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||bowel movements / day||Standard Deviation|Mean
2716879|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Bowel Movements (BM) Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15).|Baseline and 24 hours post-dose|Intent-to-treat; LOCF imputation was used|||bowel movements / day||Standard Deviation|Mean
2716880|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in the Number of SBMs Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of SBMs per day from 0 to 48 hours post-dose.|Baseline (Day 1 to Day 15) and Day 15 to Day 17 (0 to 48 hours post-dose)|Intent-to-treat population; LOCF imputation was used|||Spontaneous bowel movements / day||Standard Deviation|Mean
2716881|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Spontaneous Bowel Movements (SBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement.~Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15)."|Baseline (Day 1 to Day 15) and Day 15 to 16 (0 to 24 hours post-dose)|All randomized participants who received study drug and had at least 1 post-dose efficacy assessment completed (intent-to-treat population). Last observation carried forward (LOCF) imputation was used.|||spontaneous bowel movements / day||Standard Deviation|Mean
2716882|NCT01122030|Primary|Number of Participants With Adverse Events|"Severity of adverse events (AEs) was graded according to the following definitions:~Mild: The subject experiences awareness of symptoms but these are easily tolerated or managed without specific treatment~Moderate: The subject experiences discomfort enough to cause interference with usual activity, and/or the condition requires specific treatment~Severe: The subject is incapacitated with inability to work or do usual activity, and/or the event requires significant treatment measures.~The relationship of the event to the study drug was determined by the investigator.~A serious adverse event (SAE) is defined as any AE occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect."|From the first dose of study drug on Day 15 up to Day 24.|All participants who received any amount of study drug (safety population).|||participants|||Number
2716883|NCT01121991|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation.|AEs: Any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. TEAEs: AEs that occur during treatment with the study drug. It also included incidences of mild, moderate and severe ovarian hyperstimulation syndrome (OHSS). SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit).|ITT population: all participants who received at least one dose of the study drug.|||Number of participants|||Number
2716884|NCT01121991|Secondary|Pregnancy Loss Per Clinical Pregnancy|Preclinical miscarriage: Spontaneous cessation of a biochemical pregnancy. Early spontaneous abortion: Any spontaneous abortion occurring after confirmation of clinical pregnancy and before completion of 12 weeks of gestation. Late spontaneous abortion: any spontaneous abortion occurring between completion of 12 weeks of gestation and prior to a viable stage. Pregnancy loss per clinical pregnancy was measured as a percentage.|Post-hCG days 35-42.|Participants with confirmed clinical pregnancies.|||Percentage of pregnancy loss|||Number
2716885|NCT01121991|Secondary|Number of Live Births|A live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or placenta are intact.|Post-hCG days 15-20 to pregnancy follow up.|ITT population: all participants who received at least one dose of the study drug.|||Live births|||Number
2716886|NCT01121991|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Post-hCG Day 35-42.|ITT population: all participants who received at least one dose of the study drug.|||participants|||Number
2716903|NCT01121913|Secondary|Apparent First Order Terminal Rate Constant [λz]|Apparent First order terminal rate constant [λz] of trazodone in plasma expressed in 1/hours.|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||1/hours||Standard Deviation|Mean
2716887|NCT01121991|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy: A positive pregnancy test defined as hCG level >10 IU/L in a sample taken at least 14 days after Day 3 embryo transfer or 12 days after Day 5/6 embryo transfer with no further ultrasound confirmation of the existence of a gestational sac in the uterus. Clinical pregnancy: Existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Post-hCG days 15-20 and post-hCG days 35-42.|ITT population: all participants who received at least one dose of the study drug.|||participants|||Number
2716888|NCT01121991|Secondary|Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up|Mean number of oocytes retrieved per number of follicles aspirated on the day of ovum pick up was calculated. Oocyte retrieval is a technique used in in vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|On day of ovum pick up (Day 1 or 2 after hCG administration)|ITT population: all participants who received at least one dose of the study drug and underwent vaginal ovum pick up.|||oocytes per aspirated follicle||Standard Deviation|Mean
2716889|NCT01121991|Primary|Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF)|Mean number of oocytes undergoing ovum pick up for IVF were calculated for each participant. IVF is a process by which egg cells are fertilized by sperm outside the body, in-vitro.|On the day of ovum pick up (Day 1 or 2 after hCG administration).|Analysis population includes those participants undergoing IVF whose oocytes were assessed for maturity. Mature oocytes can be considered as Metaphase II oocytes.|||oocytes||Standard Deviation|Mean
2716890|NCT01121991|Primary|Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI)|Mean number of metaphase II oocytes was calculated for each participant undergoing ovum pick up for ICSI. ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration).|Analysis population includes those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope.|||Metaphase II Oocytes||Standard Deviation|Mean
2716891|NCT01121939|Secondary|Disease Control Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.|18 months|Includes all patients|||percentage of participants|||Number
2716892|NCT01121939|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)|||months||95% Confidence Interval|Median
2716893|NCT01121939|Secondary|Progression-Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)|||months||95% Confidence Interval|Median
2716894|NCT01121939|Secondary|Define Toxicity and Safety|To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity|18 months|All patients on study|||participants|||Number
2716895|NCT01121939|Primary|Objective Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients|||percentage of participants|||Number
2716896|NCT01121926|Secondary|Percentage Peak-Trough Fluctuation (%PTF)|"Percentage Peak-Trough Fluctuation (%PTF) of trazodone calculated as [100*(Cmax-Cmin)/Cav].~Cmax: Maximum plasma concentration Cmin: Minimum plasma concentration Cav: Average plasma concentration"|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||Percentage Peak-Trough Fluctuation||Standard Deviation|Mean
2716897|NCT01121926|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter calculated as follows:~((Cmax,ss - Cmin,ss)/Cmin,ss)*100.~Where:~Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.~It was calculated over 24 hours on day 9."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||Percentage swing||Standard Deviation|Mean
2716898|NCT01121926|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure (Tmax) at steady state.|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||hours||Full Range|Median
2716899|NCT01121926|Secondary|Plasma Concentration at 24 Hours Post-evening Dose (C24h)|Plasma concentration at 24 hours post-evening dose (C24h) in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
2716900|NCT01121926|Secondary|Minimum Plasma Concentration (Cmin,ss)|Minimum plasma concentration at steady state (Cmin,ss). Measured in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
2716901|NCT01121926|Primary|Bioequivalence Based on AUCss|"AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss.~Measured in nanograms x hours per milliliter (ng*h/mL)."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng*h/mL||Standard Deviation|Mean
2716908|NCT01121913|Primary|Bioequivalence Based on AUC(0-t)|"AUC(0-t) = Area under the plasma concentration curve vs (versus) time data pairs, where t is the time of the last quantifiable concentration.~Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||ng*h/mL||Standard Deviation|Mean
2716909|NCT01121900|Secondary|Apparent Terminal Half-life (t½.z)|The elimination half-life (T½z) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||Hours||Standard Deviation|Mean
2716910|NCT01121900|Secondary|Apparent Terminal Elimination Rate Constant (λz)|The elimination rate constant of trazodone (Lamda z). It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. This constant is used in half-life calculations.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||1/hour||Standard Deviation|Mean
2716911|NCT01121900|Secondary|Time to Maximum Plasma Concentration (Tmax)||68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||Hours||Full Range|Median
2716912|NCT01121900|Secondary|Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]||24 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||h*ng/mL||Standard Deviation|Mean
2716913|NCT01121900|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).~Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||h*ng/mL||Standard Deviation|Mean
2716914|NCT01121900|Primary|Bioequivalence Based on AUC(0-tlast)|"AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration.~Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||hr*ng/mL||Standard Deviation|Mean
2716915|NCT01121900|Primary|Bioequivalence Based Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
2716916|NCT01121757|Other Pre-specified|Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3||Within 4 months of taking single agent and 6 months of taking the combination|||||||
2716917|NCT01121757|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Evaluate the safety of lenalidomide, azacitidine and the combination of azacitidine + lenalidomide in patients with lymphoma; grading the adverse events using Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0|While taking the study drug and 30 days after the last dose||||participants|||Number
2716918|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 6 months on combination drug.|Only subjects that completed combination drug will be included in analysis.||||||
2716919|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on second drug.|Everyone who started the second drug regimen|||participants|||Number
2716920|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on first study drug.|Everyone who started the first drug regimen|||participants|||Number
2716921|NCT01121757|Primary|Response Predicted by Molecular Signatures Compared to True Response|"The predicted response (response to therapy vs. no response to therapy) using gene sequencing will be compared to the overall true response (reported in Primary Outcome 2)."|approximately one year|The number of participants who were evaluated for a response were analyzed to see if the prediction of response vs. no response through gene expression matched the true response.|||participants|||Number
2716922|NCT01121666|Secondary|Quality of Oocytes Retrieved|The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population|||Percentage of cells|||Number
2716923|NCT01121666|Secondary|Quality of Oocytes Retrieved|The maturity of the cumulus oophorus was assessed.|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population|||Percentage of cumulus oophori|||Number
2716924|NCT01121666|Secondary|Ongoing Pregnancy (Second Treatment Cycle)|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|10 weeks after embryo transfer|Population with a second treatment cycle|||Ongoing pregnancies|||Number
2716929|NCT01121666|Primary|Number of Oocytes Retrieved (Intention-to-treat Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.~The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Intention-to-treat population|||Number of retrieved oocytes||Standard Deviation|Mean
2716930|NCT01121666|Secondary|Live Birth Rate|Patients with liveborn children|After childbirth with questionnaire|Intention to treat population|||Patients with liveborn children|||Number
2716931|NCT01121666|Secondary|Ongoing Pregnancy|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|Ten weeks after embryo transfer|Intention to treat population|||Ongoing pregnancies|||Number
2716932|NCT01121666|Secondary|Clinical Pregnancy Rate|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Intention to treat population|||Clinical pregnancies|||Number
2716933|NCT01121666|Secondary|Implantation Rate|Defined as fetal sac per embryo transferred.|Five to six weeks after oocyte retrieval|Intention to treat population.|||Percentage of implantations|||Number
2716934|NCT01121666|Secondary|Number of Patients With Good Response|"Good response was defined as patients with an oocyte retrieval of four or more oocytes"|Until child birth/miscarriage, up to the end of the study|Intention to treat population.|||Participants|||Number
2716935|NCT01121666|Secondary|Number of Patients With Cycle Cancellation|Number of patients with cycle cancellation was assessed.|Until child birth/miscarriage, up to the end of the study|Intention to treat population|||Number of patients|||Number
2716936|NCT01121666|Secondary|Number of Days of r-hFSH Stimulation|Mean duration of stimulation was assessed.|At the day of hCG administration, up to 16 days|All participants were analyzed.|||days||Standard Deviation|Mean
2716937|NCT01121666|Secondary|Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts||Day 1, 2, 3 and 5 of OPU/fertilisation|Intention to treat population|||Patients with cryopreservation|||Number
2716938|NCT01121666|Secondary|Embryo Quality: Mean Number of Blastomeres|"Main embryo quality parameter mean number of blastomeres"|Day 2 of OPU/fertilisation|Intention to treat population|||Number of blastomeres at day 3||Standard Deviation|Mean
2716939|NCT01121666|Secondary|Fertilisation Rate of Oocytes|Fertilisation rate was assessed|1 day after ovum pick-up|Intention to treat population|||percentage of oocytes||Standard Deviation|Mean
2716940|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with ovum pick-up|34-36 hours after hCG administration|Intention to treat population|||Participants|||Number
2716941|NCT01121666|Secondary|Total Dose of r-hFSH Administered|Total dose of r-hFSH required was assessed.|Day of hCG administration (after maximum 16 days of r-hFSH treatment)|All participants were analyzed.|||IU||Standard Deviation|Mean
2716942|NCT01121666|Secondary|E2 Concentration at Day 8 and at Day of hCG Administration|The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.|Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)|All participants were analyzed.|||pmol/ L||Standard Deviation|Mean
2716943|NCT01121666|Secondary|Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation|The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.|Day 8 of stimulation|All participants were analyzed.|||Number of follicles||Standard Deviation|Mean
2716944|NCT01121666|Primary|Number of Oocytes Retrieved (Per Protocol Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.~The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Per protocol population|||Number of retrieved oocytes||Standard Deviation|Mean
2716945|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tmax was observed directly from data as time of first occurrence.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716946|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tlast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tlast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tlast was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716947|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmax was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716948|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmin|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmin) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmin was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716949|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUC24|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUC24) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUC24 was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716950|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUClast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUClast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716951|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tmax. Tmax was observed directly from data as time of first occurrence.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716952|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tlast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tlast. Tlast was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716953|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmax. Cmax was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716954|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmin|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmin. Cmin was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716955|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUC10|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUC10. AUC10 was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716956|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUClast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUClast. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716957|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for dacomitinib and PF-05199265. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716958|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tlast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for dacomitinib and PF-05199265. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716959|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Cmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for dacomitinib and PF-05199265. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716960|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUC24|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUC24 for dacomitinib and PF-05199265. AUC24 was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716961|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUClast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for dacomitinib and PF-05199265. AUClast was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716962|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase -Time to Maximum Plasma Concentration (Tmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for crizotinib and PF-06260182. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716963|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Time of Last Quantifiable Concentration (Tlast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for crizotinib and PF-06260182. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
2716964|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Maximum Plasma Concentration (Cmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for crizotinib and PF-06260182. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2716965|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Curve 10 (AUC10)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). AUC10 was calculated using Linear/Log trapezoidal method. The below analysis table included geometric Mean and Geometric Coefficient of Variation of AUC10 for crizotinib and PF-06260182. Arithmetic mean was presented if the n=2.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716966|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Concentration (AUClast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for crizotinib and PF-06260182. AUClast was calculated using Linear/Log trapezoidal method.|Cycle 1 (C1)/Day 1 (D1), C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2716967|NCT01121575|Secondary|Number of Participants With ROS1 Gene Translocation at Baseline|Sample analyses were performed in accordance to GLP guidance and included translocation detection (RNA based) for ROS1 gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. However, number of participants analyzed in the below table included the participants evaluated for ROS1 gene translocation.|||Participants|||Number
2716968|NCT01121575|Secondary|Number of Participants With PIK3CA Mutation at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for PIK3CA gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
2716969|NCT01121575|Secondary|Number of Participants With KRAS Mutation (GLY12CYS) at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for KRAS gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
2716970|NCT01121575|Secondary|Number of Participants With EGFR Mutation at Baseline|Sample analyses were performed in accordance to Good Laboratory Practice (GLP) guidance and included mutation detection for EGFR gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
2716971|NCT01121575|Secondary|Plasma Concentration of sMet by Study Visits|This outcome measure presented the plasma concentration of sMet at different study visits. s-Met was analyzed using an enzyme-linked immunosorbent assay (ELISA).|At screening and Cycle 1 Day 1 (C1D1) (6 hours post dose), and C1D15, C2D1, C2D15 (all predose).|The soluble protein analysis population included participants in safety analysis who had a screening or C1D1 soluble protein assessment, and at least one on-treatment soluble protein assessment (C1D14 C2D1 or C2D14).|||pg/mL||Standard Deviation|Mean
2716972|NCT01121575|Secondary|Number of Participants With c-Met, HER2, EGFR Amplification and ALK Rearrangement at Baseline Using FISH Method|Participants showed amplification of c-Met, HER2, and EGFR in the tumor cells and gene rearrangement of ALK are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
2716973|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (EGFR, and c-Met) at Baseline Using Fluorescent in Situ Hybridization (FISH) Method|Expression of tumor biomarkers EGFR and cMet at Baseline (using FISH method) are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Ratio||Full Range|Median
2717065|NCT01121393|Secondary|Disease Control (DC)|DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374|The randomised set.|||percentage of participants||95% Confidence Interval|Number
2716974|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (HGF, EGFR, and c-Met ) at Baseline Using Immunohistochemistry (IHC) Method|Tumor biomarkers such as HGF, EGFR, and c-Met were analyzed in tumor cells (neoplastic compartment) of tumor specimens from both expansion cohorts 1 and 2 by IHC. The H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+, where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum calculated score of 0 to maximum calculated score of 300, where 0 correspond to no expression and maximum score of 300 indicates the strongest expression. However, the biomarker expression level (higher or lower) was not a predictor of outcome.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||H-Score||Full Range|Median
2716975|NCT01121575|Secondary|Progression Free Survival (PFS) in Expansion Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. In Expansion Cohort 1, two participants had censored reasons of “no adequate baseline”, of which one participant had a censored reason “no tumor assessment data available.|||Months||95% Confidence Interval|Median
2716976|NCT01121575|Secondary|Progression Free Survival (PFS) in Escalation Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||Months||95% Confidence Interval|Median
2716977|NCT01121575|Secondary|Duration of Response for the Only Participant Shown Partial Response in Expansion Phase|This outcome measure presented the duration of response for one participant in expansion cohort 1 who showed partial response.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|This Outcome Measure was only assessed for participants with response.|||Weeks|||Number
2716978|NCT01121575|Secondary|Number of Participants With ORR in Expansion Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants||95% Confidence Interval|Number
2716979|NCT01121575|Secondary|Number of Participants With Objective Response Rate (ORR) in Escalation Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants||95% Confidence Interval|Number
2716980|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to RECIST (1.1) as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants|||Number
2716981|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) - 1.1 as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants|||Number
2717848|NCT01116687|Secondary|Number of Related Serious Adverse Events (SAEs)|Study drug related grade 3-4 toxicities. To measure Adverse Events, investigators used the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Study duration of 12 months|All evaluable participants|||events|||Number
2716982|NCT01121575|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase|DLTs were those AEs which occurred in Cycle 1 of treatment in Dose Escalation Phase which may be attributed to study drug [combined Crizotinib (PF-02341066) plus Dacomitinib (PF-00299804)] without a clear alternative explanation and despite the use of adequate/maximal medical intervention as dictated by local institutional clinical practices or the judgment of the investigator. The following events were considered DLTs (using CTCAE version 4.02);1. Grade ≥4 hematologic events. 2. Grade ≥3 non-hematological events (except Grade 3/4 asymptomatic hypophosphatemia and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea had to have persisted at Grade 3 or 4 despite maximal medical therapy. Grade 3 hypertension will be considered a DLT only if the event is unmanageable by standard approved pharmacologic agents or if the symptomatic sequelae are identified despite appropriate medical intervention.|Cycle 1 (4 weeks)|The DLT evaluable population was defined as safety analysis (SA) participants in the Dose Escalation phase who did not have a major treatment deviation during the first cycle.|||Participants|||Number
2716983|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||Participants|||Number
2716984|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||participants|||Number
2716985|NCT01121575|Primary|Overview of Treatment-emergent All Causalities AEs in Expansion Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||Participants|||Number
2716986|NCT01121575|Primary|Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. Serious adverse event (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||participants|||Number
2716987|NCT01121562|Secondary|Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).|"Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, observed concentration multiplied by 37.5 over actual dose.~SU012662 is an active metabolite of sunitinib."|Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1|"The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. n in the measured values means number of participants analyzed."|||nanogram/mL||Standard Deviation|Mean
2716988|NCT01121562|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.|Up to 3 years from the last subject registration to the study|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.~OS was not analyzed due to short of events."|||Months||95% Confidence Interval|Median
2718335|NCT01113541|Secondary|Change From Baseline in Insulin Levels||Baseline, Week 52 or Early Termination|PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study.|||international units per milliliter||Full Range|Median
2716989|NCT01121562|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.~Median PFS had not yet been reached due to short of events."|||Months||95% Confidence Interval|Median
2716990|NCT01121562|Secondary|Tumor Shrinkage|Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication. n  in the measured values means number of participants analyzed in the cycle."|||percent change||Standard Deviation|Mean
2716991|NCT01121562|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2716992|NCT01121562|Primary|Clinical Benefit Response Rate (CBR)|"CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks.~Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started."|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2716993|NCT01121549|Secondary|Time to Disease Progression (TTP)|Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.|Baseline up to Year 3|Time to disease progression was considered complementary to RFS and hence, was not analyzed.||||||
2716994|NCT01121549|Secondary|Recurrence-free Survival (RFS)|Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.|Baseline up to Year 3|A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.|||weeks||Full Range|Median
2716995|NCT01121549|Secondary|Percentage of Participants Who Discontinued the Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||percentage of participants|||Number
2716996|NCT01121549|Secondary|Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy||Baseline up to Year 3|FAS included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
2716997|NCT01121549|Secondary|Number of Participants With Reasons for Discontinuing Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
2716998|NCT01121549|Secondary|Number of Missed Exemestane Doses||Week 25, 49, 73, 97, 121, 145|Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.|||missed doses||Standard Deviation|Mean
2716999|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug|An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
2717000|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
2717001|NCT01121536|Primary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|"HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of participants with both a baseline and post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2717002|NCT01121536|Primary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both a baseline and post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2717003|NCT01121536|Secondary|Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or the last post-baseline assessment)|Full analysis set of participants with both a baseline and post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2717004|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression|"The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set|||units on a scale||Standard Deviation|Mean
2717005|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|"The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set|||units on a scale||Standard Deviation|Mean
2717006|NCT01121536|Primary|Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated.~- C-SSRS=Columbia Suicide Severity Rating Scale"|Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit|Safety population; only 19 participants were asked the last three questions as the inclusion of these questions depends on physician assessment.|||participants|||Number
2717007|NCT01121536|Primary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|"The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline (double-blind study) and treatment assessments during the open-label study.|||units on a scale||Standard Deviation|Mean
2717008|NCT01121536|Primary|Change From Baseline to Endpoint in Body Weight|Baseline was the score before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both baseline and post-baseline assessments.|||kg||Standard Deviation|Mean
2717009|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set|||units on a scale||Standard Deviation|Mean
2717010|NCT01121536|Primary|Physical Examination Shifts From Baseline to Endpoint|"Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint.~HEENT = Head, Eye, Ear, Nose and Throat exam"|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with baseline and endpoint assessments Participants n=: General appearance 785, HEENT 784, Chest and lungs 785, Heart 785, Abdomen 785, Musculoskeletal 785, Skin 785, Lymph nodes 780, Neurological 784|||participants|||Number
2717011|NCT01121536|Primary|Change From Baseline to Endpoint in Electrocardiogram (ECG) Values|"ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination).~RR= inter-beat intervals"|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of treated participants with both baseline and post-baseline ECG assessments|||msec||Standard Deviation|Mean
2717012|NCT01121536|Primary|Participants With Clinically Significant Abnormal Vital Signs Values|"Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria:~Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline~Pulse low: <=50 bpm and decrease of >=15 bpm from baseline~Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline~Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline~Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline"|Day 1 to Month 6|Safety population with post-baseline vital signs assessments|||participants|||Number
2717013|NCT01121536|Primary|Participants With Clinically Significant Abnormal Urinalysis Values|Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline.|Day 1 to Month 6|Safety population with post-baseline urinalysis assessments|||participants|||Number
2717014|NCT01121536|Primary|Participants With Clinically Significant Abnormal Hematology Values|"Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L.~Hemoglobin with a normal range of 115-181 g/L~Hematocrit with a normal range of 0.34-0.54 L/L~Platelet counts with a normal range of 130-400 10^9/L~ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L"|Day 1 to Month 6|Safety population with post-baseline hematology assessments|||participants|||Number
2717015|NCT01121536|Primary|Participants With Clinically Significant Abnormal Serum Chemistry Values|"Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women.~GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L~ALT = alanine aminotransferase with a normal range of 6-43 U/L~BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L~AST = aspartate aminotransferase with a normal range of 9-36 U/L"|Day 1 to Month 6|Safety population with post-baseline serum chemistry assessments|||participants|||Number
2717016|NCT01121536|Primary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 up to Month 6|Safety population|||participants|||Number
2717017|NCT01121484|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8|10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF|||cm||Standard Deviation|Mean
2717018|NCT01121484|Secondary|Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)|This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF|||Units on a scale||Standard Deviation|Mean
2717019|NCT01121484|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.|Baseline, Week 8|FAS|||Units on a scale||Standard Deviation|Mean
2717020|NCT01121484|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF|||Units on a scale||Standard Deviation|Mean
2717021|NCT01121484|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS; LOCF|||participants|||Number
2717102|NCT01121185|Secondary|Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||days|||Number
2717022|NCT01121484|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8|HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.|Baseline, Week 8|Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2717023|NCT01121406|Secondary|Biomarkers and Pharmacogenetics Analysis (Optional)|This endpoint has not been statistically analysed in the study report|6 months|||||||
2717024|NCT01121406|Secondary|Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS|Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Litres||Geometric Coefficient of Variation|Geometric Mean
2717025|NCT01121406|Secondary|CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration|CL; total clearance of BI 6727 BS in plasma after intravenous administration|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2717026|NCT01121406|Secondary|MRT; Mean Residence Time of BI 6727 BS in the Body|MRT; Mean residence time of BI 6727 BS in the body|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2717027|NCT01121406|Secondary|t1/2; Terminal Half-life of CD 10899 BS in Plasma|t1/2; Terminal half-life of CD 10899 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2717028|NCT01121406|Secondary|t1/2; Terminal Half-life of BI 6727 BS in Plasma|t1/2; Terminal half-life of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2717029|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma|tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2717030|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma|tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2717031|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma|Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2717032|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma|Cmax; maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2717033|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2717034|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2717247|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 8||||participants|||Number
2717035|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2717036|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2717037|NCT01121406|Secondary|Clinically Relevant Changes in Laboratory and ECG Data|Clinically relevant changes in laboratory and ECG data|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS|||percentage of participants|||Number
2717038|NCT01121406|Secondary|Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS|||participants|||Number
2717039|NCT01121406|Secondary|Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)|"Three most troublesome disease specific symptoms, defined by the patient at baseline.~Patients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.~Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks)|TS|||weeks||Inter-Quartile Range|Median
2717040|NCT01121406|Secondary|Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)|"Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
2717041|NCT01121406|Secondary|Time to Deterioration in Pain/ Quality of Life (QOL)|"Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
2717042|NCT01121406|Secondary|Time to Deterioration in Fatigue/Quality of Life (QOL)|"Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
2717043|NCT01121406|Secondary|Time to Deterioration in Global Health Status/Quality of Life (QOL)|"Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
2717044|NCT01121406|Secondary|Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.~Also according to the below criterias,~In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.~Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or~Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or~Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart."|At screening and every 6 weeks thereafter (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
2717248|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 4||||participants|||Number
2717045|NCT01121406|Secondary|Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.~Biological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter."|At screening and every 6 weeks thereafter (Up to 213 weeks)|TS|||participants|||Number
2717046|NCT01121406|Secondary|Best Overall Response|"Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.~Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed."|time from the date of randomisation until study completion/discontinuation; Up to 213 weeks|TS|||participants|||Number
2717047|NCT01121406|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death irrespective of the cause of the death.|From randomization until death or study discontinuation; Up to 213 weeks|TS|||weeks||Inter-Quartile Range|Median
2717048|NCT01121406|Secondary|Progression Free Survival (PFS)|"Progression-free survival of a patient was based on the investigator's assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.~Definition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.~Non-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions"|From randomization until disease progression, death or study discontinuation; Up to 213 weeks|TS|||weeks||Inter-Quartile Range|Median
2717049|NCT01121406|Primary|Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).|Week 24|TS|||percentage of participants||95% Confidence Interval|Number
2717050|NCT01121393|Secondary|Changes in Safety Laboratory Parameters|"Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.~For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented."|From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.|Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter are of interest.|||percentage of participants|||Number
2717051|NCT01121393|Secondary|Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events|Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.|From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.|The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.|||percentage of participants|||Number
2717052|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 43|Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 43 (course 3, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2717053|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 29|Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 29 (course 2, visit 2)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2717054|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 22|Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the Pharmacokinetics (PK) assessment period).|Day 22 (course 2, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.|||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2717055|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Pain|"HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.|The randomised set.|||months||95% Confidence Interval|Median
2717056|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea|"HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.|The randomised set.|||months||95% Confidence Interval|Median
2717057|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing|"HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.|The randomised set.|||months||95% Confidence Interval|Median
2717058|NCT01121393|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|"The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.~ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;~Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;~Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;~Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;~Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;~Dead"|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.|The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.|||percentage of participants|||Number
2717059|NCT01121393|Secondary|Change From Baseline in Body Weight|The change from baseline to the lowest and the last body weight recorded or during the the study.|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.|The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.|||kilogram (kg)||Standard Deviation|Mean
2717060|NCT01121393|Secondary|Tumour Shrinkage|"Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~The means are adjusted for baseline sum of lesions and EGFR mutation category."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374|The randomised set. There were ony 220 patients in the Afatinib arm and 101 patients in the Gemcitabine / Cisplatin arm with baseline and post-baseline target lesion measurements.|||millimetre (mm)||Standard Error|Mean
2717061|NCT01121393|Secondary|Duration of Disease Control|For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates.|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374|The randomised set with disease control.|||months||95% Confidence Interval|Median
2717062|NCT01121393|Secondary|Duration of Objective Response|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374|The Randomised set with an objective response.|||months||95% Confidence Interval|Median
2717063|NCT01121393|Secondary|Time to Objective Response (OR)|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.~Outcome data are the percentage of patients with OR by each scheduled tumour assessment."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374|The RS included all patients randomised to receive treatment, whether treated or not.|||percentage of participants|||Number
2717064|NCT01121393|Secondary|Overall Survival (OS)|"OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.~Median time results from unstratified Kaplan-Meier estimates."|From randomisation up to 374 weeks|The randomised set.|||months||95% Confidence Interval|Median
2717268|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 4|Change in albumincorrected serum calcium from Baseline to week 4|Baseline and week 4||||mmol/L||Standard Deviation|Mean
2717066|NCT01121393|Secondary|Objective Response (OR)|"OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.~CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.~PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.~(Exact 95% Confidence interval by Clopper and Pearson.)"|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374|The randomised set.|||percentage of participants||95% Confidence Interval|Number
2717067|NCT01121393|Primary|Progression-free Survival|"The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.~Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.|||months||95% Confidence Interval|Median
2717068|NCT01121263|Secondary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:~Death~Stroke~Myocardial infarction~Repeat revascularization"|Occurence of MACCE through the end of study up to two years||||participants|||Number
2717069|NCT01121263|Primary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:~Death~Stroke~Myocardial Infarction~Repeat Revascularization"|Month 12||||participants|||Number
2717070|NCT01121250|Primary|Spouse Self-report of Resilience|Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience|Baseline, 6 months, and 12 months|All participants with resilience data at baseline, 6 and 12 months|||units on a scale||Standard Deviation|Mean
2717071|NCT01121250|Primary|Spouse Self-report of Depression|Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression|Baseline, 6 months, and 12 months|All participations with depression data at baseline, six and 12 months|||units on a scale||Standard Deviation|Mean
2717072|NCT01121250|Primary|Spouse Self-report of Anxiety|Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety|Baseline, 6 months, and 12 months|All participants with anxiety data at baseline, six months, and twelve months|||units on a scale||Standard Deviation|Mean
2717073|NCT01121224|Secondary|Number of Participants With Stroke||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717074|NCT01121224|Secondary|Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.|The device-oriented composite endpoint for target lesion failure is defined as the composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization.|Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717075|NCT01121224|Secondary|Patient-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.|The patient-oriented composite endpoint is defined as the composite endpoint of any death, any myocardial infarction, or target vessel revascularization.|Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717076|NCT01121224|Secondary|Number of Participants With Non-Target Revascularization||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717077|NCT01121224|Secondary|Number of Participants With Non-Target Revascularization||12 months||||Participants|||Count of Participants
2717078|NCT01121224|Secondary|Number of Participants With Target Lesion Revascularization (TLR)||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717079|NCT01121224|Secondary|Device-oriented Composite Endpoint of Target Lesion Failure Will be Used as a Secondary Outcome|"The Device-oriented composite endpoint of Target lesion failure is defined as the composite of cardiac or unknown death, target vessel myocardial infarction, and target lesion revascularization.~Target lesion revascularization (TLR) will be defined as any repeat percutaneous intervention of the target SVG lesion or bypass surgery of the target SVG lesion performed for restenosis or other complication of the target lesion. The target lesion will be defined as the treated SVG segment from 5 mm proximal to the stent to 5 mm distal to the stent."|12 months||||Participants|||Count of Participants
2717080|NCT01121224|Secondary|Procedural Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding)|Incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.|Discharge from Index Hospitalization (an average of 36 hours)||||Participants|||Count of Participants
2717103|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Total Bilirubin|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the total bilirubin at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||mg/dL||Full Range|Mean
2717081|NCT01121224|Secondary|Number of Participants With Definite or Probable Stent Thrombosis|"Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.~Probable Stent Thrombosis will clinically be considered to have occurred after index Saphenous Vein aortocoronary bypass Graft (SVG) stenting (the Percutaneous Coronary Intervention (PCI) immediately after randomization) in the following cases: a) any unexplained death within the first 30 days OR b) Irrespective of the time after the index procedure, any MI which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717082|NCT01121224|Secondary|Number of Participants With Any Revascularization||12 months||||Participants|||Count of Participants
2717083|NCT01121224|Secondary|Number of Participants With Target Vessel Myocardial Infarction||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717084|NCT01121224|Secondary|Number of Participants With Target Lesion Revascularization (TLR)||12 months||||Participants|||Count of Participants
2717085|NCT01121224|Secondary|In-stent Neointima Proliferation as Measured by Intravascular Ultrasonography||12 months||2019-12-31|12/2019||||
2717086|NCT01121224|Secondary|Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.||12 months||2019-12-31|12/2019||||
2717087|NCT01121224|Secondary|Number of Participants With Stroke||12 months||||Participants|||Count of Participants
2717088|NCT01121224|Secondary|In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.||12 months||2019-12-31|12/2019||||
2717089|NCT01121224|Secondary|Patient-Oriented Composite Endpoint Will be Used as Secondary Outcome|"The patient-oriented composite endpoint is defined as the composite of all-cause death, any myocardial infarction and target vessel revascularization.~Target vessel (SVG) revascularization (TVR) will be defined as any repeat percutaneous intervention or surgical bypass of any segment of the target SVG and the native coronary vessel distal to the SVG anastomosis. Non-target vessel revascularization will be defined as any repeat percutaneous intervention or surgical bypass of any SVG or any native coronary vessel apart from the target SVG and the native coronary artery supplied by the target SVG."|12 months||||Participants|||Count of Participants
2717090|NCT01121224|Secondary|Number of Participants With Target Vessel Revascularization (TVR)||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717091|NCT01121224|Secondary|Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition|"Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.~Angiographic Confirmation of Stent Thrombosis will be defined as the presence of thrombus originating in a study stent, or in the segment 5mm proximal or distal to the stent AND fulfillment of at least one of the following 5 criteria within a 48 hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes suggestive of acute ischemia~Rise and fall of cardiac biomarkers~Nonocclusive intracoronary thrombus seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream~Occlusive intracoronary thrombus Pathological Confirmation of stent thrombosis will be defined as evidence of recent thrombus with the stent determined at autopsy or via examination of tissue retrieved following thrombectomy."|12 months||||Participants|||Count of Participants
2717092|NCT01121224|Secondary|Number of Participants With Myocardial Infarction (MI)||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717093|NCT01121224|Secondary|Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.||Entire Duration of Follow-up (median 2.7 years)||||Participants|||Count of Participants
2717094|NCT01121224|Secondary|Procedural Success|The procedural success rate and the incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.|Discharge from Index Hospitalization (an average of 36 hours)||||Participants|||Count of Participants
2717095|NCT01121224|Secondary|Incremental Cost-effectiveness of DES Relative to BMS||12 months||2019-12-31|12/2019||||
2717096|NCT01121224|Primary|Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization||12 months||||Participants|||Count of Participants
2717097|NCT01121224|Primary|Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction||12 months||||Participants|||Count of Participants
2717098|NCT01121224|Primary|Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death||12 months||||Participants|||Count of Participants
2717099|NCT01121211|Primary|Change From Baseline in Depression Symptom Severity|Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)|Baseline, 24 weeks|All subjects who received at least one dose of study medication|||HAM-D score on a scale||Standard Deviation|Mean
2717100|NCT01121211|Primary|Change From Baseline in Weight|Weight in kilograms|Baseline, 24 Weeks|All subjects who received at least one dose of study medication|||kilograms||Standard Deviation|Mean
2717101|NCT01121185|Post-Hoc|Time To Viral Rebound Post-Transplantation(Serum HCV RNA Increased ≥ 1 log10 From Viral Nadir)|The time of viral rebound was defined as the time of the first measurement of serum HCV RNA increased ≥ 1 log10 from the viral nadir (the lowest serum HCV RNA level post-transplantation). Serum HCV RNA was measured by RT-PCR.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||days||Full Range|Mean
2717104|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the ALT at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||U/L||Full Range|Mean
2717105|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the INR at each time-point. The INR is the ratio of a patient's prothrombin time to a control sample, raised to the power of the ISI value (International Sensitivity Index) for the batch of tissue factor being used for the assay.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||unitless||Full Range|Mean
2717106|NCT01121185|Secondary|Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42|Liver biopsies obtained at baseline (day 0) and day 42 post-transplantation were assessed for histologic evidence of hepatitis by a pathologist blinded to treatment assignment using the Ishak modification of the Knodell histologic grading system to assign a histologic activity index (HAI) score. The HAI score consists of a sum of four components: 1) periportal or periseptal interface hepatitis; 2) confluent necrosis; 3) focal lytic necrosis, apoptosis and focal inflammation; 4) portal inflammation. The total HAI score can range from a minimum of 0 to a maximum of 18, with higher scores indicating more severe hepatic inflammation.|Baseline Day 0 and Day 42|The 11 subjects who were randomized, initiated study infusions, and underwent transplantation were included in the analysis population. On day 0, all subjects had pre-transplant biopsy specimens available for analysis. On day 42, 4 subjects in the MBL-HCV1 group and 5 subjects in the placebo group had biopsy specimens available for analysis.|||Histologic activity index (HAI) score||Full Range|Median
2717107|NCT01121185|Secondary|Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation|Serum HCV RNA was measured by quantitative RT-PCR. The change in HCV RNA from baseline was obtained by calculating the difference between the baseline pre-transplantation HCV RNA level and the HCV RNA level measured at each study visit.|Baseline and Day 3, 14, 28 and 42 Post-Transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||log10 IU/mL||Full Range|Median
2717108|NCT01121185|Secondary|The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation|Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Subjects were asked at scheduled study visits through day 42 whether they experienced solicited adverse reactions (fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives). In addition to these solicited adverse events, subjects were asked at all scheduled study visits through day 56 to report any other adverse events, regardless of whether the event was thought to be related to the study infusions. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 12.0)|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||events|||Number
2717109|NCT01121185|Primary|Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|At Day 42 post-transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||percentage of participants|||Number
2717110|NCT01121172|Secondary|Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents|Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group|First day after enrollment|Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group.|||participants|||Number
2717111|NCT01121172|Primary|Serum Apelin Levels|Apelin levels were measured in serum of participants, in fasting state|First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning||||ng/ml||Full Range|Median
2717112|NCT01121146|Secondary|Patient Satisfaction|"Patient satisfaction was quantified by asking participants to respond yes or no to the question, Are you satisfied with the results of your hip operation?"|Minimum 9-year follow-up|Satisfaction rates were evaluated among 84 participants with unrevised hips who had Marathon and 70 participants with unrevised hips who had Enduron polyethylene. These participants had minimum 9-year follow-up and responded to the question about satisfaction.|||percentage of participants|||Number
2717113|NCT01121146|Secondary|Harris Hip Score|The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).|Minimum 9-year follow-up|Harris Hip Scores were evaluated for 74 unrevised hips with Marathon and 65 unrevised hips with Enduron polyethylene that had minimum 9-year follow-up and complete data to compute a score.|||score on a 100 point scale||Standard Deviation|Mean
2717114|NCT01121146|Secondary|Rate of Reoperation|The rate of reoperation was based on the number of reoperations in each group. Any additional surgery after a participant's initial hip replacement was considered a reoperation.|10-year follow-up|All 116 hips randomized to Marathon polyethylene and all 114 hips randomized to Enduron polyethylene were included in the analysis population to determine the rate of reoperation.|||THAs|||Number
2717160|NCT01120691|Secondary|Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.|||exacerbations per year|Participants||Number
2717115|NCT01121146|Secondary|Polyethylene Wear|A single reviewer, who was blinded to the type of polyethylene liner, evaluated femoral head penetration among all unrevised hips with minimum 9-year radiographic follow-up using serial anteroposterior pelvic radiographs. Two-dimensional head penetration was determined for each follow-up radiograph relative to the immediate post-operative (nominal 6-week follow-up) reference view using Hip Suite Analysis version 8.0 with elliptical correction, a validated, computer-assisted technique. A linear wear rate was evaluated for each hip that had a minimum of three follow-up radiographs by using a least-squares linear regression to calculate the slope of the best-fit line for the wear vector magnitude versus time in situ data. The slope from this regression represented the steady-state linear wear rate. The steady-state linear wear rate data from all hips in a group was used to compute a mean polyethylene wear value.|Minimum 9-year radiographic follow-up|At least 3 head penetration measurements evaluated with Martell’s Hip Suite Analysis software were available for 76 unrevised hips with Marathon and 66 unrevised hips with Enduron polyethylene.|||millimeters per year||Standard Deviation|Mean
2717116|NCT01121146|Primary|Incidence of Clinically Significant Osteolysis|The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis. Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph. To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software. Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.|Minimum 9-year radiographic follow-up|Minimum 9-year radiographs used to assess osteolysis were available for 79 unrevised hips with Marathon and 68 unrevised hips with Enduron polyethylene.|||unrevised THAs|||Number
2717117|NCT01120990|Primary|Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
2717118|NCT01120990|Primary|Diastolic Blood Pressure Measured by Tested Device.|Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
2717119|NCT01120990|Primary|Systolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
2717120|NCT01120990|Primary|Systolic Blood Pressure Measured by Tested Device.|Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
2717121|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months||||Eyes|Participants||Number
2717122|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months||||Eyes|Participants||Number
2717123|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months||||Eyes|Participants||Number
2717177|NCT01120600|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 24 months (plus 14 days) after first dose of study drug|All randomized participants who took at least one dose of study drug|||Participants|||Number
2717124|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months||||Eyes|Participants||Number
2717125|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months||||Eyes|Participants||Number
2717126|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months||||Eyes|Participants||Number
2717127|NCT01120899|Primary|Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 months||||Eyes|Participants||Number
2717128|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months||||Eyes|Participants||Number
2717129|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months||||Eyes|Participants||Number
2717130|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 24 Months||||percentage change in retinal thickness|Participants|Standard Deviation|Mean
2717131|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 18 Months||||percentage change in retinal thickness|Participants|Standard Deviation|Mean
2717132|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 12 Months||||percentage change in retinal thickness|Participants|Standard Deviation|Mean
2717133|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months||||percentage change|Participants|Standard Deviation|Mean
2717134|NCT01120899|Secondary|Change in BCVA in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months||||ETDRS letters|Participants|Standard Deviation|Mean
2717135|NCT01120899|Secondary|Change in BCVA in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months||||ETDRS letters|Participants|Standard Deviation|Mean
2717136|NCT01120899|Secondary|Change in BCVA in the Study Eye at 12 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 12 Months||||ETDRS Letters|Participants|Standard Deviation|Mean
2717137|NCT01120899|Secondary|Change in BCVA in the Study Eye at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months||||ETDRS Letters|Participants|Standard Deviation|Mean
2717138|NCT01120834|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR)|2 cycles||||Participants|||Count of Participants
2717139|NCT01120808|Primary|Count of Participants With Blisters||1 week|Participants with available data were analyzed|||Participants|||Count of Participants
2717140|NCT01120782|Primary|Prescription Equivalence|Number of subjects whose prescription is the same for the two lenses tested.|after 15 minutes of lens wear|All completed subjects.|||participants|||Number
2717141|NCT01120756|Secondary|Functional Evaluations: Change From Baseline on the Goal Processing Scale|Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study. The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory. Scores range from 1-10. Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.|Baseline, 2-3 Weeks Post-intervention|This measurement was used for the comparison of Goal-oriented attentional self-regulation training and Brain Health Education interventions. Also, we lost a total of n=2 participants to attrition from baseline to follow-up. This included n=1 from the Goal-Oriented Attentional Self-regulation training and n=1 from the Brain Health Education.|||units on a scale||Standard Deviation|Mean
2717142|NCT01120756|Primary|Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions|We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.|Baseline, Within 2-3 weeks Post-intervention|We lost a total of n=2 participants to attrition from baseline to follow-up. This included n=1 from the Goal-Oriented Attentional Self-regulation training and n=1 from the Brain Health Education.|||Change to Z (composite) score||Standard Deviation|Mean
2717143|NCT01120717|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
2717178|NCT01120600|Secondary|Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24|Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-P1NP data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717144|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
2717145|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
2717146|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
2717147|NCT01120717|Secondary|Pre-dose FEV1|Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.|52 weeks|Full analysis set - all randomized patients who received at least one dose of study drug. Only patients with the required data were included in this analysis.|||Liter||Standard Error|Least Squares Mean
2717148|NCT01120717|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks + Follow-up (Up to Day 394)|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.|||participants|||Number
2717149|NCT01120704|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.~Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence."|Assessed at 52 weeks after target quit day||||participants|||Number
2717150|NCT01120704|Secondary|Latency to Relapse|Latency to Relapse during the first 12 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored|Assessed during the first 12 months post-quit after target quit day||||participants|||Number
2717151|NCT01120691|Secondary|St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.|12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.|||units on a scale||Standard Error|Least Squares Mean
2717152|NCT01120691|Secondary|Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set(mFAS)included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis|||percentage of days||Standard Error|Least Squares Mean
2717153|NCT01120691|Secondary|Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period|The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set mFAS included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis|||# puffs||Standard Error|Least Squares Mean
2717154|NCT01120691|Secondary|Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.~Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis"|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.|||L (liters)||Standard Error|Least Squares Mean
2717155|NCT01120691|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.~Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve.~The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates."|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.|||L (liters)||Standard Error|Least Squares Mean
2717156|NCT01120691|Secondary|Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points|Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26, 52, 64, 76 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis.|||exacerbations per year|Participants|95% Confidence Interval|Number
2717157|NCT01120691|Secondary|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized|||percentage of participants|||Number
2717158|NCT01120691|Secondary|Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.|Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized. Analysis population included patients with study withdrawal or premature discontinuation for any reason.|||days||95% Confidence Interval|Median
2717159|NCT01120691|Secondary|Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics|The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site with GCP non-compliance. This is a sub-group analysis with mutually exclusive population in each category for analysis.|||Days||Standard Deviation|Mean
2717269|NCT01120223|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8-weeks||||percent subjects|||Number
2717161|NCT01120691|Secondary|Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. Only patients with a moderate or severe COPD exacerbation were included in this analysis.|||days||95% Confidence Interval|Median
2717162|NCT01120691|Secondary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|76 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance.|||Exacerbations per year|Participants||Number
2717163|NCT01120691|Primary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site , which had major issues with Good Clinical Practice (GCP) compliance.|||Exacerbations per year|Participants||Number
2717164|NCT01120639|Secondary|Treatment Failure Analysis|"Treatment failure in individual participants, ie, tumor recurrence or metastasis, can be described by the location relative to the first treatment failure (ie, infield, marginal, or distal), as further defined below.~Failure pattern is defined as tumor recurrence or metastasis relative to the primary lesion that is~Infield: at tumor or within 5 mm~Marginal: > 5 mm or ≤ 20 mm from tumor~Distal: > 20 mm from tumor~The outcome will be reported as the number of participants who failed treatment for each type of failure, ie, infield, marginal, or distal failure."|18 months|If the location of a participant's 1st treatment failure could not be determined, then a location assessment relative to any 2nd treatment failure can not done (null result), and for this reason, this analysis only includes participants for whom the location of the 1st treatment failure could be determined.|||Participants|||Count of Participants
2717165|NCT01120639|Secondary|Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey|"MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). MDASI-BT quality of life survey has 23 questions and responses are on scale of 0 to 10 with 0 indicating did not interfere (most favorable) and 10 indicating interfered completely (least favorable). A participant's overall score is computed as the mean of that participant's individual scores, and can range 0 to 10. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean difference from baseline with 95% confidence interval. A positive value for the mean indicates worsening quality of life."|12 months|Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated.|||score on a scale||95% Confidence Interval|Mean
2717166|NCT01120639|Secondary|Quality of Life by Brain-20 Survey|"Brain-20 (BN-20) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The Brain-20 (BN-20) quality of life survey has 20 questions and responses are on scale of 1 to 4 with 1 indicating not at all (most favorable) and 4 indicating very much (least favorable). The total score can range from 20 to 80, and the result is expressed as the difference from baseline (study entry) to 12 months after the start of treatment. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the mean with 95% confidence interval."|12 months|Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated.|||score on a scale||95% Confidence Interval|Mean
2717179|NCT01120600|Secondary|Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24|Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-BSAP data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717167|NCT01120639|Secondary|Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey|"European Organization for Research and Treatment of Cancer (EORTC-QLQ C30) quality of life surveys were administered at study entry and 12 months after treatment initiation to assess health-related quality of life (HR-QOL). The EORTC-QLQ C30 survey has 30 questions and responses are on scale of 1 to 4 with 1 indicating not at all and 4 indicating very much. The total score can range from 30 to 120. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and is expressed as the mean of the difference from baseline to 12 months, with 95% confidence interval."|12 Months|Some participants did not contribute one or both of the baseline (study entry) and 12-month assessments, and the outcome (difference from baseline / study entry to 12 months after the start of treatment could not be calculated.|||score on a scale||95% Confidence Interval|Mean
2717168|NCT01120639|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed as those participants remaining alive with any tumor status following radiotherapy after 20 months. The outcome is stratified by Planning Target Volume (PTV) < 60 cm³ or 60 to 150 cm³, and expressed as the median value with 95% confidence interval.|20 Months.||||Months||95% Confidence Interval|Median
2717169|NCT01120639|Secondary|Progression-free Survival|Progression-free survival (PFS) following radiotherapy, measured in months. Progressive disease (PD) is defined as: New tumor lesion, or > 25% increase in the product of the 2 greatest diameters of target lesion, as determined by computed tomography (CT) or magnetic resonance imaging (MRI), provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation. The outcome is expressed as the median with 95% confidence interval for each cohort.|18 Months.|Participants who have not progresses and have not reached reached 18 months post-treatment are not included.|||Months||95% Confidence Interval|Median
2717170|NCT01120639|Secondary|Percent of Participants With Radiographic Response|"Radiographic response rate was assessed following radiotherapy until disease progression. Response is considered to be the sum and proportion participants that achieved a complete response (CR); partial response (PR); or minor response (MR). The outcome is expressed as a number without dispersion for each cohort.~CR: Tumor is no longer detected by computed tomography (CT) or magnetic resonance imaging (MRI).~PR: Decrease in the product of the two greatest diameters > 50%, as determined by CT or MRI, with no new lesions, and the same or lower dose of dexamethasone.~MR: Decrease in the product of the two greatest diameters < 50%, as determined by CT or MRI, and neither PR nor PD.~PD: New tumor lesion, or > 25% increase in the product of the two greatest diameters of target lesion, as determined by CT or MRI, provided that within 2 months of completion of radiotherapy, the participant has not had a decrease in steroid dose since the last evaluation."|6 months||||Percentage of participants|||Number
2717171|NCT01120639|Secondary|Long-term Toxicity After More Than 30 Days|"Long-term toxicity is defined as treatment-related adverse events (any grade or any Body System) that occur ≥ 30 days after receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each dose level.~Long-term toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only."|12 months||||Number of adverse events|||Number
2717172|NCT01120639|Secondary|Number of Acute Toxicity Within 30 Days|"Acute toxicity is defined as treatment-related adverse events that occur within 30 days of receiving radiotherapy. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 is used to grade adverse events. The non-stratified outcome is reported as number of treatment-related adverse events observed for each radiotherapy dose level.~Acute toxicity is based on radiotherapy dose level not tumor volume, and is reported by radiotherapy dose level only."|30 days||||adverse events|||Number
2717173|NCT01120639|Primary|Number of Dose-limiting Toxicities (DLTs)|"The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either:~The highest radiation dose per protocol, or~The radiation dose at which dose-limiting toxicities (DLTs) occurred in ≥ 2 of 3 participants at a dose level, and/or ≥ 2 of 6 participants, at a dose level.~Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity [Common Terminology Criteria for Adverse Events (CTCAE) v4] occurring within 30 days of stereotactic radiosurgery (SRS).~The non-stratified outcome is reported as the number of DLTs observed in by radiation dose and by strata (Planning Target Volume (PTV) < 60 cm³ and from 60 to 150 cm³)."|30 days|Participants receiving each radiotherapy level were stratified by tumor size.|||Number of DLT observed|||Number
2717174|NCT01120626|Secondary|Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist is a 58-item symptom checklist for assessing problem behaviors. The ABC was rated by each participant's parent. Each item is rated on a four-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The ABC Total score (range 0-174) is the sum of all individual item scores. Higher score indicates more maladaptive behaviors/worse outcome.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 39 of 42 participants were administered the ABC at week 12.|||units on a scale||Standard Deviation|Mean
2717175|NCT01120626|Primary|Contingency Naming Test (CNT) Performance Score|Week 12 Contingency Naming Test (CNT) performance score on Rule 2 (naming shapes) and on Rule 3 (If the inside shape matches the outside shape, name the color, otherwise, name the outside shape). Performance score is the number of correct responses per minute, calculated by dividing the number of correct responses by the time taken to complete the 27 items, and multiplying by 60. Higher scores indicate faster and more accurate responding.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 37 of 42 randomized participants completed CNT Rule 2 at week 12. 34 of 42 randomized participants completed CNT Rule 3 at week 12.|||correct responses per minute||Standard Deviation|Mean
2717176|NCT01120600|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 24 months after first dose of study drug|All randomized participants who took at least one dose of study drug|||Participants|||Number
2718336|NCT01113541|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag.|||percent HbA1c||Full Range|Median
2717180|NCT01120600|Secondary|Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24|Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available U-NTx/Cr data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717181|NCT01120600|Secondary|Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24|Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-CTx data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717182|NCT01120600|Secondary|Percentage Change From Baseline in Trochanter BMD at Month 24|Trochanter BMD was assessed by DXA at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available trochanter BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717183|NCT01120600|Secondary|Percentage Change From Baseline in Femoral Neck BMD at Month 24|Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available femoral neck BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717184|NCT01120600|Secondary|Percentage Change From Baseline in Total Hip BMD at Month 24|Total hip BMD was assessed by DXA at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available total hip BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717185|NCT01120600|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24|Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available lumbar spine BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
2717186|NCT01120405|Secondary|Urine Output|Urine volume in milliliter (mL) during the first postoperative hours|From Day 0 until Postoperative Day 1|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||mL||Standard Deviation|Mean
2717187|NCT01120405|Secondary|Number of Participants With Chest Pain During the 3 Postoperative Days|Patients with Chest Pain reported at least once per day during the 3 Postoperative Days|From Day 0 until Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||participants|||Number
2717188|NCT01120405|Secondary|Vital Signs (Heart Rate Changes)|Changes from baseline for Heart Rate (HR)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||beats per minute||Standard Deviation|Mean
2717189|NCT01120405|Secondary|Vital Signs (SBP and DBP Changes)|Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||mm Hg||Standard Deviation|Mean
2717190|NCT01120405|Secondary|Systolic Blood Pressure (SBP)|Repeated Systolic Blood Pressure measurements during the perioperative period|From pre-induction to recovery of anesthesia|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||mm Hg||Standard Deviation|Mean
2717191|NCT01120405|Secondary|Number of Participants With Composite Endpoint|Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717192|NCT01120405|Secondary|Number of Participants Who Died From Cardiac Origin|No patient died from a cardiac cause during the 3 postoperative days.|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717193|NCT01120405|Secondary|Number of Participants With Life-Threatening Arrhythmia|Patients with Life-Threatening Arrhythmia in the FAS|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717194|NCT01120405|Secondary|Number of Participants With Cerebro-Vascular Event|Patients with Cerebro-Vascular Event in the FAS|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717195|NCT01120405|Secondary|Number of Participants With Myocardial Infarction (MI)|Patients with Confirmed Myocardial Infarction (MI) by the Investigators|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717209|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717196|NCT01120405|Secondary|Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)|At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)|3 Postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717197|NCT01120405|Primary|Number of Participants With Myocardial Necrosis (MN)|Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)|3 Postoperative Days|Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
2717198|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 4-year visit is 1502 days.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants|||Number
2717199|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 3-year visit is 1053-1137 days.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants|||Number
2717200|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 2-year visit is 688-772 days.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants|||Number
2717201|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717202|NCT01120379|Secondary|Major Bleeding Complications (Site Reported)|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717203|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of Clinical Events Committee (CEC)-adjudicated Thrombolysis In Myocardial Infarction (TIMI) major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717204|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717205|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717206|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717207|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717208|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717210|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717211|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717212|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717213|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717214|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717215|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717216|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717217|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717218|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717219|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717220|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717221|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2718452|NCT01111851|Secondary|Brain NK1-receptor Occupancy at 120 Hours Post Dose||120 hours post dose|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
2717222|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717223|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717224|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717225|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717226|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717227|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717228|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) as Defined by ARC|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717229|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717230|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2717231|NCT01120275|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2717232|NCT01120275|Secondary|Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response|Complete disappearance of all measurable and non-measurable disease, or greater than or equal to 30% decrease under baseline of the sum of the longest diameters of all target measurable lesions.|Disease assessments for response were performed every 6 weeks, up to 3 years||||portation of participants||95% Confidence Interval|Number
2717233|NCT01120275|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years.||||Months||95% Confidence Interval|Median
2717234|NCT01120275|Primary|Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.|Disease assessments were performed every 6 weeks, up to 3 years.||||Months||95% Confidence Interval|Median
2717235|NCT01120236|Other Pre-specified|Change in Level of Insulin|Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (insulin) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.|Baseline to 12 weeks||||ulU/mL||Standard Deviation|Mean
2717236|NCT01120236|Other Pre-specified|Change in Level of IGFBP2, IGFBP3 and Growth Hormone|Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: IGFBP2, IGFBP3 and Growth Hormone) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.|Baseline to 12 weeks||||pg/mL||Standard Deviation|Mean
2717237|NCT01120236|Other Pre-specified|Change in Level of IGF-I, Free IGF-I and C-peptide|Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: IGF-I, free IGF-I and C-peptide) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.|Baseline to 12 weeks||||ng/mL||Standard Deviation|Mean
2717238|NCT01120236|Secondary|Change in Level of CTCs|Will be correlated with 28-week PSA response.|Baseline to 28 weeks|Among the 50 patients in this biomarker substudy, 1 was ineligible for the trial, 6 started LHRH therapy prior to registration, and 4 had CTC blood samples that were not assay evaluable. The remaining 39 patients were included in this analysis.|||Participants|||Count of Participants
2717239|NCT01120236|Secondary|Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts|The Friedman test will be used to evaluate correlations between microRNA measures (CT) and Baseline CTCs.|Baseline|Among the 50 patients in this biomarker substudy, 14 patients were excluded: 1 ineligible for S0925, 6 started LHRH therapy prior to registration, 3 had insufficient miRNA samples and 4 had insufficient CTC samples. The remaining 36 patients were used in this analysis.|||Cycle Threshold (CT)||Full Range|Median
2717240|NCT01120236|Secondary|Correlation of microRNA Measures With 28-week PSA Response|The Friedman test will be used to evaluate correlations between microRNA measures (CT) and 28-week PSA response.|Baseline to 28 weeks|Among the 50 patients in this biomarker substudy, 10 patients were excluded: 1 ineligible for S0925, 6 started LHRH therapy prior to registration, 3 had insufficient miRNA samples. The remaining 40 patienets were included in this analysis.|||Cycle Threshold (CT)||Full Range|Median
2717241|NCT01120236|Secondary|Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)|The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.|Up to 5 years|The data from this trial was intended to be used as a validation dataset for the prognostic model built using data from SWOG-9346. However, data for this objective was not collected.||||||
2717242|NCT01120236|Secondary|Proportion of Patients Who do Not Achieve a Partial PSA Response|A partial PSA response is considered <= 4 ng/mL|Up to 5 years|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.|||participants|||Number
2717243|NCT01120236|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment were included in toxicity analysis. Four patients on Arm I (androgen deprivation and cixutumumab) and two patients on Arm II (androgen deprivation therapy) did not receive any protocol treatment and were therefore excluded from this analysis.|||Participants|||Number
2717244|NCT01120236|Primary|Undetectable PSA Rate|Undetectable PSA rate (<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment|7 months|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.|||participants|||Number
2717245|NCT01120223|Secondary|Withdrawal|"How many subjects withdrew from the study. Reasons for withdrawal:~due to exclusion criteria emerging, due to AE(s), or due to other reason"|Week 4 and 8||||participants|||Number
2717246|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment (up to 8 weeks)||||participants|||Number
2717249|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|Week 2||||participants|||Number
2717250|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and End of treatment (up to 8 weeks)||||percent of change||Standard Deviation|Mean
2717251|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8||||percent change||Standard Deviation|Mean
2717252|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.|Baseline and week 4||||percent of change||Standard Deviation|Mean
2717253|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 2||||percentage of change||Standard Deviation|Mean
2717254|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment|End of treatment (up to 8 weeks)||||participants|||Number
2717255|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment|Change in urinary calcium:creatinine ratio from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)||||mmol/g||Standard Deviation|Mean
2717256|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8|Change in urinary calcium:creatinine ratio from Baseline to week 8|Baseline and week 8||||mmol/g||Standard Deviation|Mean
2717257|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4|Change in urinary calcium:creatinine ratio from Baseline to week 4|Baseline and week 4||||mmol/g||Standard Deviation|Mean
2717258|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment|Change in 24-hour urinary calcium excretion from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)||||mmol/24hr||Standard Deviation|Mean
2717259|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8|Change in 24-hour urinary calcium excretion from Baseline to week 8|Baseline and week 8||||mmol/24hr||Standard Deviation|Mean
2717260|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4|Change in 24-hour urinary calcium excretion from Baseline to week 4|Baseline and week 4||||mmol/24hr||Standard Deviation|Mean
2717261|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to End of Treatment|Change in albumincorrected serum calcium from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)||||mmol/L||Standard Error|Mean
2717262|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8|Week 8||||participants|||Number
2717263|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4|Week 4||||participants|||Number
2717264|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|Week 2||||participants|||Number
2717265|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 8|Change in plasma PTH (parathyroid hormone) from Baseline to week 8|Baseline and week 8||||ng/L||Standard Deviation|Mean
2717266|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 4|Change in plasma PTH (parathyroid hormone) from Baseline to week 4|Baseline and week 4||||ng/L||Standard Deviation|Mean
2717267|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 8|Change in albumincorrected serum calcium from Baseline to week 8|Baseline and week 8||||mmol/L||Standard Deviation|Mean
2717270|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Calculated Systemic Vascular Resistance (SVR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Calculated Systemic Vascular Resistance (SVR) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||dyn.s.cm-5||Standard Error|Least Squares Mean
2717271|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Diastolic Pressure (PADP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Square (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
2717272|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Systolic Pressure (PASP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Systolic Pressure (PASP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
2717273|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Stroke Volume (SV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Stroke Volume (SV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mL/beat||Standard Error|Least Squares Mean
2717274|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Fractional Shortening (FS)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Fractional Shortening (FS) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||percentage||Standard Error|Least Squares Mean
2717275|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular Ejection Fraction (LVEF)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular Ejection Fraction (LVEF) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||percentage||Standard Error|Least Squares Mean
2717276|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of 30 ng/kg/Min Infusion]) in Left Ventricular End Diastolic Volume (LVEDV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular End Diastolic Volume (LVEDV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mL||Standard Error|Least Squares Mean
2717277|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular End Systolic Volume (LVESV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mL||Standard Error|Least Squares Mean
2717278|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Diastolic Blood Pressure (DBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of LS mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in Least Square (LS) means (and associated confidence intervals) for change from Baseline in diastolic blood pressure(DBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
2717279|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Systolic Blood Pressure (SBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in systolic blood pressure (SBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
2717280|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Heart Rate (HR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in heart rate (HR) at each time point as well as treatment group LS means and Standard Errors.|At 1-hour, 2 hours and 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2717281|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Capillary Wedge Pressure (PCWP)|The effect of JNJ-39588146 on pulmonary capillary wedge pressure (PCWP) was evaluated by administering multiple ascending doses of JNJ-39588146 or placebo over a 3-hour intravenous (IV) infusion period to patients with heart failure. The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from baseline in PCWP at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
2717282|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI)|The effect of JNJ-39588146 on cardiac index (CI), a hemodynamic parameter that relates heart performance to the size of the individual measured in liters per minute per square metre (l/min/m2) was evaluated in patients with heart failure (HF). The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in CI at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||L/min/m2||Standard Error|Least Squares Mean
2717283|NCT01120197|Secondary|Falls-Efficacy Scale-International|A 16- item self report or interview- based questionnaire assessing the fear of falling during basic and more demanding activities of daily living (Yardley et al. 2005). Each item is scored on a four point scale. Minimun score indicating low concern about falling is 16. The maximun score indication high concern about falling is 64.|Baseline, 3 months follow-up, 12 months follow up|||||||
2717284|NCT01120197|Secondary|General Health Questionnaire 20 (GHQ20).|"GHQ-20 is a generic instrument and registers distress and psychopathology. GHQ-20 is self-administered and the answers to each item may be treated as a Likert Scale and have weights assigned to each position (0-1-2-3) where 0 is no distress, and 3 is severe distress. This gives a possible range for the total GHQ-20 score of 0-60. Higher scores indicating poor qol."|At baseline, 3 and 12 months after baseline||||units on a scale||Standard Deviation|Mean
2717285|NCT01120197|Secondary|QUALEFFO 41|"Quality of Life Questionnaire issued by the European Foundation for Osteoporosis (QUALEFFO-41), is a disease-specific questionnaire to be used by patients with vertebral fractures attributed to osteoporosis. QUALEFFO-41 is self-administered and contains questions in five domains: pain, ability to perform physical functions, social functioning, general health perception and mental performance. These five domains can be evaluated individually or be represented in a total score. All scores in all the domains are expressed in values ranging from 0-100, where 0 represents the best and 100 the worst. The total QALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100.~High scores indicate poor quality of life."|At baseline, 3 and 12 months after the baseline||||units on a scale||Standard Deviation|Mean
2717286|NCT01120197|Secondary|Functional Reach|"The maximum distance in centimetres that can be reached forward in a standing position while maintaining a fixed base of support. Subjects will be instructed to stand sideways against a wall in a natural position and stretch one arm forward level with the shoulder. The position of the third metacarpophalangeal (MCP) joint was taken as the zero point. With the body tilted forward as far as possible, the subjects continued to stretch the arm parallel to the ground.~Amount of cm indicate better balance."|At baseline, 3 and 12 months after the baseline||||Centimetres||Standard Deviation|Mean
2717287|NCT01120197|Secondary|Timed Up & Go Test (TUG)|The subject will be instructed to rise from a chair with a seat height of 43 cm, walk 3 m, turn around, return and sit down again, wearing ordinary footwear and use customary walking aids if necessary.|At baseline, 3 and 12 months after the baseline.||||Seconds||Standard Deviation|Mean
2717288|NCT01120197|Primary|Time Used to Walk 20 m at Maximal Speed.|Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded|At baseline, 3 and 12 months after the baseline||||Seconds||Standard Deviation|Mean
2717289|NCT01120184|Secondary|OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels|"OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for Trastuzumab Emtansine + Placebo and confidence interval values for Trastuzumab + Taxane and Trastuzumab Emtansine + Pertuzumab are censored values."|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (Low HER2 mRNA Subpopulation).|||months||Full Range|Median
2717290|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (Low HER2 mRNA Subpopulation).|||percentage of participants|||Number
2717291|NCT01120184|Secondary|OS at Clinical Cutoff Among Those With High HER2 mRNA Levels|OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (High HER2 mRNA Subpopulation).|||months||Full Range|Median
2717292|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (High HER2 mRNA Subpopulation).|||percentage of participants|||Number
2717293|NCT01120184|Secondary|PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation).|||months||Full Range|Median
2717294|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation).|||percentage of participants|||Number
2717295|NCT01120184|Secondary|PFS According to IRF Assessment Among Those With High HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation).|||months||Full Range|Median
2717296|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation).|||percentage of participants|||Number
2717297|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation): All randomized participants with below-the-median HER2 mRNA expression (value less than or equal to [≤] 59.71). Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants|||Number
2717298|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation): All randomized participants with above-the-median HER2 mRNA expression (value greater than [>] 59.71). Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants|||Number
2717299|NCT01120184|Secondary|Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score|The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).|Baseline, Cycle 7 (Week 18)|Number of participants analysed=participants from ITT population who reported conduct of daily activities. Here, 'n' signifies the number of participants with available data at specified category.|||units on a scale||95% Confidence Interval|Mean
2717300|NCT01120184|Secondary|Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score|The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)|Baseline, Cycle 7 (Week 18)|Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.|||percent of work||95% Confidence Interval|Mean
2717301|NCT01120184|Secondary|Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score|The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as [mean score at the assessment visit minus mean score at Baseline]. The higher the score, the higher the level of impairment or burden.|Baseline, Cycle 7 (Week 18)|ITT Population. Here, 'n' signifies the number of participants with available data at baseline and Cycle 7 (Week 18).|||units on a scale||95% Confidence Interval|Mean
2717328|NCT01120093|Secondary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2717302|NCT01120184|Secondary|Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score|The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.|||months||95% Confidence Interval|Median
2717303|NCT01120184|Secondary|Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score|The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100.|Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)|ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.|||percentage of participants|||Number
2717304|NCT01120184|Secondary|Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module|The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.|At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2|ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.|||percentage of participants|||Number
2717305|NCT01120184|Secondary|Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module|The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.|At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2|ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.|||percentage of participants|||Number
2717306|NCT01120184|Secondary|Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score|The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)|ITT Population (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C.|||percentage of participants||95% Confidence Interval|Number
2717307|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|Data were not analyzed. Protocol Amendment E removed this outcome measure as a secondary endpoint, because it was redundant to another prespecified secondary endpoint.||||||
2717329|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2718468|NCT01111604|Secondary|Minimum Concentration (Cmin) at Day 1|Cmin is the minimum peak concentration measured in blood plasma after drug infusion.|Day 1 (cycles 1, 5, 9, and 13)|Zero participants analyzed. OM entered incorrectly and no data collected to report.||||||
2717308|NCT01120184|Secondary|Duration of Response According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population. Only participants achieving CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2717309|NCT01120184|Secondary|Percentage of Participants With Objective Response According to Investigator Assessment|Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2717310|NCT01120184|Secondary|Percentage of Participants With Objective Response According to IRF Assessment|Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate [ORR]) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population. Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2717311|NCT01120184|Secondary|Percentage of Participants With Hospitalization|Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|Safety population|||percentage of participants||95% Confidence Interval|Number
2717312|NCT01120184|Secondary|Hospitalization Days|Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|Safety population. Number of participants analyzed=participants with hospitalization and data available for calculation of the parameter.|||days||Full Range|Median
2717313|NCT01120184|Secondary|Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death.|Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)|Safety population|||percentage of participants|||Number
2717314|NCT01120184|Secondary|Percentage of Participants With Grade 3-4 Laboratory Parameters|Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.|Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014|Safety population. Number of participants analyzed=participants with available data for the outcome.|||percentage of participants|||Number
2717315|NCT01120184|Secondary|Percentage of Participants With Grade 5 Adverse Events|Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.|Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)|Safety population|||percentage of participants|||Number
2717316|NCT01120184|Secondary|Overall Survival Truncated at 2 Years|Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.|From randomization until 2 years|ITT Population.|||percentage of participants|||Number
2717317|NCT01120184|Secondary|Percentage of Participants Who Died at 2 Years||From randomization until 2 years|ITT Population|||percentage of participants|||Number
2717318|NCT01120184|Secondary|Percentage of Participants With Grade ≥3 Adverse Events|Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death.|Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose|Safety Population: All treated participants. Additionally, 2 participants randomized to trastuzumab+taxane received 3 cycles of trastuzumab emtansine and were included in trastuzumab emtansine+placebo arm. 6 participants randomized to trastuzumab emtansine+placebo received pertuzumab and were included in trastuzumab emtansine+pertuzumab arm.|||percentage of participants|||Number
2717319|NCT01120184|Secondary|One-Year Survival Rate|The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error.|From randomization until 1 year|ITT Population.|||percentage probability of being alive||95% Confidence Interval|Number
2717320|NCT01120184|Secondary|Time to Treatment Failure (TTF)|Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population.|||months||95% Confidence Interval|Median
2717321|NCT01120184|Secondary|Percentage of Participants Experiencing Treatment Failure|Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population.|||percentage of participants|||Number
2717322|NCT01120184|Secondary|PFS According to Investigator Assessment|Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||months||95% Confidence Interval|Median
2717323|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to Investigator Assessment|Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||percentage of participants|||Number
2717324|NCT01120184|Secondary|Overall Survival (OS) at Clinical Cutoff|OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population.|||months||95% Confidence Interval|Median
2717325|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population.|||percentage of participants|||Number
2717326|NCT01120184|Primary|Progression-Free Survival (PFS) According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||months||95% Confidence Interval|Median
2717327|NCT01120184|Primary|Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment|Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||percentage of participants|||Number
2717330|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2717331|NCT01120093|Primary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2717332|NCT01120067|Primary|McGill Pain Questionnaire|McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.|6 months||||units on a scale||Standard Deviation|Mean
2717333|NCT01120028|Secondary|Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy)|Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization|2 years post-transplantation||||Participants|||Count of Participants
2717334|NCT01120028|Secondary|Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy)|Occurrence of any cancer reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus).|2 years post-transplantation||||Participants|||Count of Participants
2717335|NCT01120028|Secondary|Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy)|Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus).|2 years post-transplantation||||Participants|||Count of Participants
2717336|NCT01120028|Secondary|Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy)|Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported within Period 1 (randomization to induction therapy of either Alemtuzumab (Campath-1H) and Tacrolimus, or Basiliximab and Tacrolimus).|6-months post-transplantation||||Participants|||Count of Participants
2717337|NCT01120028|Secondary|Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy)|Return to dialysis or re-transplantation by 18-months after randomization to maintenance therapy.|2 years post-transplantation||||Participants|||Count of Participants
2717338|NCT01120028|Secondary|Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy)|Return to dialysis or re-transplantation by 6-months after randomization to induction therapy.|6 months post-transplantation||||Participants|||Count of Participants
2717339|NCT01120028|Primary|Graft Function (at 18-months After Randomization to Maintenance Therapy)|Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.|2 years post-transplantation||||mL/min/1.73m²||Standard Error|Mean
2717340|NCT01120028|Primary|Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy|Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))|6 months post-transplantation||||Participants|||Count of Participants
2717341|NCT01119963|Secondary|Duration of Latency Period|"Secondary Outcomes:~- Duration of latency period (time from randomization to birth)"|average number of days measured from day of study entry until day of delivery|Intent to treat population (included all participants who were randomized, whether they received study medication or not).|||days||Standard Deviation|Mean
2717342|NCT01119963|Primary|Gestational Age at Delivery|Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.|Measured from day of last menstrual cycle to day of birth and measured in weeks.|Intent to treat population (included all participants who were randomized, whether they received study medication or not).|||weeks.||Standard Deviation|Mean
2717343|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity on Days 1, 7 and 14|"Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. (see Outcome Measure #23).~Trough FVC was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717344|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717345|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717385|NCT01119937|Secondary|Change in Pre-dose FEV1 From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.|||liters||Standard Deviation|Mean
2717346|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717347|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717348|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717349|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4 hours (postdose) on days 1, 7 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717350|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717351|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Trough FEV1 was measured on Days 1, 7 and 14 of treatment. Trough FEV1 was defined as the mean of the FEV1 values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|23 hours 15 mins and 23 hours 45 mins post-dose on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717352|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity After 28 Days of Treatment|Forced Vital Capacity (FVC) after 28 days of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. Trough FVC was defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose.|23 hours 15 mins and 23 hours 45 mins post-dose on Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717353|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time. Measurements were taken at 25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28."|25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717354|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Day 28 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717470|NCT01119716|Primary|Clinical Type of Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with admission (baseline) atrial fibrillation data available.|||Percentage of Participants|||Number
2717355|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours)|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose). FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717356|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717357|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second by Treatment at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
2717358|NCT01119950|Primary|Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19).~All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717359|NCT01119950|Secondary|Mean Daily Use of Rescue Medication by Treatment at Different Time Points|Mean daily use of rescue medication by treatment and time points. Baseline was defined as the average of the total number of puffs of rescue medication during the week prior to treatment start, divided by the total number of days with non-missing rescue data during that week, then puffs were counted during weeks 1, 2, 3 and 4 postdose.|Baseline, Weeks 1, 2, 3 and 4|Only patients with a non-missing value at both period baseline and the respective post-baseline visit were included. The modeling approach is not suitable for these data as the modeling assumptions do not hold.|||Number of Puffs||Standard Deviation|Mean
2717360|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14|"Percentage of the maximal response of NVA237 Doses on Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was assessed via spirometry. (see Outcome Measure #33).~Trough FVC is defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717361|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment.~Peak FEV1 was measured in response to all doses administered (see Outcome Measure #32). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717362|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.~FEV1 was measured in response to all doses administered (see Outcome Measure #31). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717363|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #30). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
2717364|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 in response to all doses administered (see Outcome Measure #29).~All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
2717365|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #28). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
2717366|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 hours was calculated from measurements taken at 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14, in response to all doses administered (see Outcome Measure #27).~All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
2717367|NCT01119950|Secondary|Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours, was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14.~FEV1 AUC 0-24 hours was measured on days 1 and 14 of treatment in response to all doses administered (see Outcome Measure #26). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
2717368|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on Trough FEV1 was measured on Days 1, 7 and 14.~Through FEV1 was measured in response to all doses administered (see Outcome Measure #25). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717471|NCT01119716|Primary|Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with co-morbity data available.|||Percentage of Participants|||Number
2717369|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment|"Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Forced Vital Capacity (FVC) was measured at day 28 of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC at day 28 of treatment was measured via spirometry (see Outcome Measure #24). All FVC responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FVC data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717370|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Peak FEV1 was measured at day 28 of treatment.~Peak FEV1 was measured in response to all doses administered (see Outcome Measure #23). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717371|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response within different doses/regimens of NVA237 was measured using FEV1 at 12 hours on day 28 of treatment.~FEV1 was measured in response to all doses administered (see Outcome Measure #22). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
2717372|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours) on Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours were calculated from measurements taken at: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #21). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
2717373|NCT01119950|Secondary|Forced Expiratory Volume in One Second AUC 0-24 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~The Area Under the Curve (AUC) 0-24 hours FEV1 between dosing regimens over the range 20 micrograms to 55 micrograms total daily dose at -25 min,-15 min (predose); 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC 0-24 hours FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 20), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens."|-25 min,-15 min (predose); 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||90% Confidence Interval|Mean
2717374|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours at day 28 of treatment was calculated from measurements taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #20). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response * hours||90% Confidence Interval|Mean
2717472|NCT01119716|Primary|Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with baseline cardiovascular history data.|||Percentage of Participants|||Number
2717375|NCT01119950|Secondary|Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~FEV1 was measured between dosing regimens (over the range 20 micrograms to 55 micrograms total daily dose) after 28 days of treatment.~Mean trough FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 19), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens. The theoretical responses to each dosing schedule separately and the difference between the once-daily and twice-daily regimens are represented below."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||90% Confidence Interval|Mean
2717376|NCT01119937|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
2717377|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
2717378|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
2717379|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|Safety population - all patients who received at least one dose of study drug. Only participants with the required measurements were included for each specific value.|||participants|||Number
2717380|NCT01119937|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period|Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug|||change in puffs||Standard Deviation|Mean
2717381|NCT01119937|Secondary|Change in St. George Respiratory Questionnaire From Baseline|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|Weeks 12, 24, 36, 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.|||score on a scale||Standard Deviation|Mean
2717382|NCT01119937|Secondary|Number of Patients With Moderate or Severe COPD Exacerbations|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug|||participants|||Number
2717383|NCT01119937|Secondary|Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug|||days|||Number
2717384|NCT01119937|Secondary|Change in Pre-dose FVC From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.|||liters||Standard Deviation|Mean
2718469|NCT01111604|Secondary|Maximum Concentration (Cmax) at Day 15|Cmax is the maximum peak concentration measured in blood plasma after drug infusion.|Day 15 (Cycles 1 and 5)|Zero participants analyzed. OM entered incorrectly and no data collected to report.||||||
2717386|NCT01119937|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
2717387|NCT01119898|Primary|Pain While Standing|Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Week 4|mITT population with non-missing data at Week 4|||Participants|||Count of Participants
2717388|NCT01119898|Primary|Pain While Standing|Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Baseline|mITT population|||Participants|||Count of Participants
2717389|NCT01119898|Primary|Pain While Sitting Or Lying Down|Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Week 4|mITT population with non-missing data at Week 4|||Participants|||Count of Participants
2717390|NCT01119898|Primary|Pain While Sitting Or Lying Down|Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Baseline|mITT population|||Participants|||Count of Participants
2717391|NCT01119898|Primary|Pain At Night While In Bed|Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Week 4|mITT population with non-missing data at Week 4|||Participants|||Count of Participants
2717392|NCT01119898|Primary|Pain At Night While In Bed|Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Baseline|mITT population with non-missing data at Baseline|||Participants|||Count of Participants
2717393|NCT01119898|Primary|Pain When Going Up Or Down Stairs|Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Week 4|mITT population with non-missing data at Week 4|||Participants|||Count of Participants
2717394|NCT01119898|Primary|Pain When Going Up Or Down Stairs|Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Baseline|mITT population|||Participants|||Count of Participants
2717395|NCT01119898|Primary|Pain When Walking On A Flat Surface|Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Week 4|mITT population with non-missing data at Week 4|||Participants|||Count of Participants
2717396|NCT01119898|Primary|Pain When Walking On A Flat Surface|Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.|at Baseline|mITT population|||Participants|||Count of Participants
2717397|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
2717398|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
2717399|NCT01119859|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|"Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate."|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
2718470|NCT01111604|Secondary|Maximum Concentration (Cmax) at Day 8|Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.|Day 8 (cycles 1 and 5)|Zero participants analyzed. Outcome Measure (OM) entered incorrectly and no data collected to report.||||||
2717400|NCT01119859|Secondary|Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24|The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
2717401|NCT01119859|Secondary|Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24|The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
2717402|NCT01119859|Primary|Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Units on a scale||95% Confidence Interval|Mean
2717403|NCT01119846|Secondary|Part C: Summary of AUC0-24, AUC0-t of GSK1292263 and Sitagliptin When Co-administered|The AUC0-10, AUC0-12 and AUC0-24 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post- breakfast), 1, 2, 4 (= pre lunch), 6, 10 (= immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Nanograms×hour per mL||Geometric Coefficient of Variation|Geometric Mean
2717404|NCT01119846|Secondary|Part C: Summary of T-half and Tmax of GSK1292263 and Sitagliptin When Co-administered|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (= immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2717405|NCT01119846|Secondary|Part C: Summary of Cmax of GSK1292263 and Sitagliptin When Co-administered|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (= immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
2717406|NCT01119846|Secondary|Part B: Summary of Change From Baseline in Fasted Glucagon, GLP-1, C-peptide, Total GIP, Total PYY and Insulin|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period. For breakfast, lunch and evening meal in Part B, samples were collected just after the meal and at the following times after starting each meal: 0.5, 1 and 2 hours. Samples were also collected in Part B at 24 hours post-dose. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value from post-Baseline value.|Baseline (Day 1 pre-dose) and Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Pico moles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717407|NCT01119846|Secondary|Part B: Summary of Change From Baseline in Fasted Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value from post-Baseline value.|Baseline (Day 1 pre-dose) and Day 1 (24 hours)|The PD Population included participants from the Safety Population who had any PD parameter estimates from any portion of the study.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
2718680|NCT01110252|Primary|Vital Capacity - VC|A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure.|||liters||Standard Deviation|Mean
2717408|NCT01119846|Secondary|Part B: Summary of AUC0-t and AUC0-24|The AUC 0-24 and AUC 0-t determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours on Day 1 of each treatment period|PK Population.|||Nanograms×hour per mL||Geometric Coefficient of Variation|Geometric Mean
2717409|NCT01119846|Secondary|Part B: Summary of T-max and T-lag|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours on Day 1 of each treatment period|PK Population.|||Hour||Full Range|Median
2717410|NCT01119846|Secondary|Part B: Summary of Plasma Cmax|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours on Day 1 of each treatment period.|PK Population.|||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
2717411|NCT01119846|Secondary|Part B: Number of Participants With Abnormal Vital Signs of PCI|SBP, DBP and pulse rate measurements were recorded at each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 min. Participants with abnormal clinically significant vital signs findings is presented. It was assessed on Screening, Day -1, 1, 2 (pre-dose, 1, 3, 4, 6, 10, 16 and 24 hours of each treatment period) and Follow-up (7 -10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717412|NCT01119846|Secondary|Part B: Number of Participants With Significant ECG Abnormalities|Twelve-lead ECGs was obtained in a supine position at each time point during the study using an ECG machine that automatically measured PR, QRS, QT and QTc intervals (QTcB and QTcF). Participants with abnormal clinically significant ECG findings is presented. It was assessed on Screening, Day 1 at pre-dose, 1, 2, 3, 4, 6, 10, 16, 24 hours and Follow-up (7 -10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717413|NCT01119846|Secondary|Part B: Number of Participants With Abnormal Clinical Chemistry Parameters of PCI|Clinical chemistry parameters included BUN, potassium, AST, total and direct bilirubin, creatinine, chloride, ALT, uric acid, glucose fasting, GGT, albumin, sodium, magnesium, phosphorus inorganic, calcium, total CO2, ALP, triglycerides, total cholesterol, LDL cholesterol, free fatty acid (NEFA), HDL cholesterol and total protein. It was assessed on Screening, Day -1, 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters (Glucose, High) for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717414|NCT01119846|Secondary|Part B: Number of Participants With Abnormal Hematology Parameters of PCI|Hematology parameters included platelet count, RBC count, MCV, total neutrophils, WBC absolute, MCH, lymphocytes, MCHC, monocytes, hemoglobin, eosinophils, hematocrit, reticulocytes and basophils. It was assessed on Screening, Day -1, 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717415|NCT01119846|Secondary|Part B: Number of Participants With AEs and SAEs|An AE was defined as any untoward MO in a participant temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717416|NCT01119846|Primary|Part C: Summary of Change From Baseline in Fasted Insulin|Blood samples were collected fasting pre-breakfast and pre-morning dose (PD time 0) on Days -1, 13 and 14 and then at 10, 20, 30, 60, 90, 120, 180 min after eating the standardized breakfast meal tolerance test. For lunch (4 hour post-morning dose) samples were collected just before the meal and after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (10 hour post-morning dose), BID dosing groups followed the sequence of sampling, food and dosing as for breakfast (PD sample immediately before meal, eat and then dose), then 0.5, 1, 1.5, 2 and 3 hours post-dinner. A sample was also collected 24 hours post-dose. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value minus post-Baseline value. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Baseline (Day 1 pre-dose) and Day -1, 13 and 14|The PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717417|NCT01119846|Primary|Part C: Summary of Change From Baseline in Fasted Glucose|Blood samples were collected fasting pre-breakfast and pre-morning dose (PD time 0) on Days -1, 13 and 14 and then at 10, 20, 30, 60, 90, 120, 180 min after eating the standardized breakfast meal tolerance test. For lunch (4 hour post-morning dose) samples were collected just before the meal and after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (10 hour post-morning dose), BID dosing groups followed the sequence of sampling, food and dosing as for breakfast (PD sample immediately before meal, eat and then dose), then 0.5, 1, 1.5, 2 and 3 hours post-dinner. A sample was also collected 24 hours post-dose. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value minus post-Baseline value. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Baseline (Day 1 pre-dose) and Day -1, 13 and 14.|PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717418|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Insulin Sensitivity Index|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated as 10,000/square root ([mean plasma insulin × mean plasma glucose during OGTT or meal challenge] × [fasting plasma glucose × fasting plasma insulin]). The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||1/(mg/dL)×1/(µIU/mL)||Geometric Coefficient of Variation|Geometric Mean
2717419|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Insulin Glucose Index|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated as insulin (30 min) - insulin (0 min)/glucose (30 min) - glucose (0 min). It was calculated as insulin (30 min) - insulin (0 min)/glucose (30 min) - glucose (0 min). The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||µIU/mL/mg/dL||Geometric Coefficient of Variation|Geometric Mean
2717420|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Glucose/Insulin and Insulin/Glucose Ratio|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated as insulin/glucose ratio was calculated as insulin AUC(0-3]/glucose AUC(0-3) during OGTT, while glucose/insulin ratio was calculated as glucose AUC(0-3)/insulin AUC(0-3) during OGTT. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2717421|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Disposition Index|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated by multiplying insulin glucose index with insulin sensitivity index. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||[(µIU/mL)/(mg/deciliter [dL])]^2||Geometric Coefficient of Variation|Geometric Mean
2717422|NCT01119846|Primary|Part A: Summary of the OGTT AUC (0-2) and iAUC(0-2)- C-peptide, Total GIP, GLP-1 (Active and Total), Glucagon and Total PYY and AUC 0-3 and iAUC 0-3 of Insulin|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Pico moles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717423|NCT01119846|Primary|Part A: Summary of the OGTT AUC (0-3) and iAUC(0-3)-Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717424|NCT01119846|Primary|Part A: Summary of the AUC 0-12 and iAUC 0-12 of Glucagon, Glucagon-like Peptide (GLP; Active and Total)-1, C-peptide, Total Glucose-dependent Insulinotropic Peptide (GIP) and Total Peptide Tyrosine-tyrosine (PYY) and AUC 0-13 and iAUC 0-13 of Insulin|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population.|||Pico moles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717425|NCT01119846|Primary|Part A: Summary of the AUC 0-13, AUC 0-24, Incremental AUC (iAUC) 0-13 and iAUC 0-24 of Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717524|NCT01119443|Primary|Cmax,ss (Fed Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
2717426|NCT01119846|Primary|Part A: Summary of Change From Baseline in Fasted Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value from post-Baseline value. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Baseline (Day 1 pre-dose) and Day 1 (24 hours)|The PD Population included participants from the Safety Population who had any PD parameter estimates from any portion of the study.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
2717427|NCT01119846|Primary|Part C: Relationships Between GSK1292263 Drug Exposures and Insulin Sensitivity|"Blood samples for the determination of insulin were collected fasting pre-breakfast and then pre-morning dose (PD time 0) on Days -1, 13 and 14, and then at 10, 20, 30, 60, 90, 120, 180 min after eating the standardized breakfast meal tolerance test. For lunch (approximately 4 hour post-morning dose) samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hour post-morning dose), BID dosing groups followed the sequence of sampling, food and dosing as for breakfast (PD sample immediately before meal, eat and then dose), then 0.5, 1, 1.5, 2 and 3 hours post-dinner. A sample was also collected 24 hours post-dose.~When this results in multiple samples at the same time point, only one sample was collected (example: 24 hours post first-dose = pre-dose [time 0] for the second dose)."|Day -1, 13 and 14|PK/PD Population.|||mL/min×1/µIU×10^4||Geometric Coefficient of Variation|Geometric Mean
2717428|NCT01119846|Primary|Part A: Relationships Between GSK1292263 Drug Exposures and Insulin Sensitivity|Blood samples for the determination of insulin were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. The unit of measure is mL/min×1/micro international unit×10^4 (mL/min×1/µIU×10^4).|Day 1 of each treatment period|The PK/PD Population included all participants who were in both the PK and PD populations, as well as those in the PD population who received the placebo treatment.|||mL/min×1/µIU×10^4||Geometric Coefficient of Variation|Geometric Mean
2717429|NCT01119846|Primary|Part C: Summary of Time Invariance Ratio (Rs) of Cmax|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post-breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected. Cmax for one participant from 50 BID x 14 day was not analyzed due to positive definite G Matrix.|Days 1, 7, 13 and 14|PK Population.|||Ratio||90% Confidence Interval|Geometric Least Squares Mean
2717430|NCT01119846|Primary|Part C: Summary of Time Invariance Ratio (Rs) of AUC0-24 for Once Daily Dose of GSK1292263|The AUC0-24 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post-breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||90% Confidence Interval|Geometric Mean
2717431|NCT01119846|Primary|Part C: Summary of Time Invariance Ratio (Rs) of AUC0-10 for BID Dose of GSK1292263|The AUC0-10 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post-breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||90% Confidence Interval|Geometric Mean
2717432|NCT01119846|Primary|Part C: Summary of Accumulation Ratio (Ro)|Ro was derived as follows: Ro = Day 13 (AUC0-24)/Day 1 (AUC0-24) for once daily dosing; Ro = Day 13 AM (AUC0-10)/Day 1 AM (AUC0-10) for BID dosing and Ro = Day 13 (AUC0-24)/Day 1 (AUC0-24) for BID dosing. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected. Data presented for Day 13 and Day 14.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2718681|NCT01110252|Secondary|Arterial Blood Gases Test - Pa CO2|presence of CO2 in the arterial blood.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure|||mm Hg||Standard Deviation|Mean
2717433|NCT01119846|Primary|Part C: Summary of AUC0-10, AUC0-12 and AUC0-24|The AUC0-10, AUC0-12 and AUC0-24 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For QD and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post- breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2717434|NCT01119846|Primary|Part C: Summary of T-max and T-lag|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2717435|NCT01119846|Primary|Part C: Summary of Plasma Cmax|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.|||Nanograms per millimeter||Geometric Coefficient of Variation|Geometric Least Squares Mean
2717436|NCT01119846|Primary|Part C: Number of Participants With Abnormal Vital Signs of PCI|SBP, DBP and pulse rate measurements were recorded at each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Participants with abnormal clinically significant vital signs findings is presented. It was assessed on Screening, on Days -1 to 14 in a fasting state early in the morning (prior to morning dosing on days 1-14) and at Follow-up. On Days 1, 7, 13 and 14, it was also taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose each treatment period and Follow-up (7 to 10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717437|NCT01119846|Primary|Part C: Number of Participants With Significant ECG Abnormalities|Twelve-lead ECGs was obtained in a supine position at each time point during the study using an ECG machine that automatically measured PR, QRS, QT and QTc intervals (QTcB and QTcF). Participants with abnormal clinically significant ECG findings is presented. It was assessed on Screening, on Day -1, 1, 7, 13 and 14 pre-breakfast dose (fasting) and at 1, 3, 6, 9, 12 and 24 hours of each treatment period and Follow-up (7 to 10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717438|NCT01119846|Primary|Part C: Number of Participants With Abnormal Clinical Chemistry Parameters of PCI|Clinical chemistry parameters included BUN, potassium, AST, total and direct bilirubin, creatinine, chloride, ALT, uric acid, glucose fasting, GGT, albumin, sodium, magnesium, phosphorus inorganic, calcium, total CO2, ALP, triglycerides, total cholesterol, LDL cholesterol, free fatty acid (NEFA), HDL cholesterol and total protein. It was assessed on Screening, Day -2 (can be non-fasting) and prior to breakfast (early in the morning, fasting) on Days 1, 7 and 14, and on Day 15 prior to checkout, (=24 hours post-dose) of each treatment period and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717439|NCT01119846|Primary|Part C: Number of Participants With Abnormal Hematology Parameters of PCI|Hematology parameters included platelet count, RBC count, MCV, total neutrophils, WBC absolute, MCH, lymphocytes, MCHC, monocytes, hemoglobin, eosinophils, hematocrit, reticulocytes and basophils. It was assessed on Screening, Day -2 (can be non-fasting) and prior to breakfast (early in the morning, fasting) on Days 1, 7 and 14, and on Day 15 prior to checkout, (=24 hours post-dose) of each treatment period and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717440|NCT01119846|Primary|Part C: Number of Participants With AEs and SAEs|An AE was defined as any untoward MO in a participant temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
2717525|NCT01119443|Primary|AUCτ,ss (Fed Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng·h/mL||Standard Deviation|Geometric Mean
2717441|NCT01119846|Primary|Part A: Summary of Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) and Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)|The AUC 0-24 and AUC 0-t determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours on Day 1 of each treatment period|Pharmacokinetic Population.|||Nanograms×hour per milliliters||Geometric Coefficient of Variation|Geometric Mean
2717442|NCT01119846|Primary|Part A: Summary of Time to Maximum Concentration (T-max) and Lag Time Before Observation of Drug Concentration in Sampled Matrix (T-lag)|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. Blood samples for the determination of PK was collected on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours on Day 1 of each treatment period|Pharmacokinetic Population.|||Hour||Full Range|Median
2717443|NCT01119846|Primary|Part A: Summary of Maximum Plasma Concentration (Cmax)|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for the determination of PKs was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours on Day 1 of each treatment period|The Pharmacokinetic Population included all participants from the Safety Population who have any pharmacokinetic parameter estimates from any portion of the study.|||Nanograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
2717444|NCT01119846|Primary|Part A: Number of Participants With Abnormal Vital Signs of PCI|Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate measurements were recorded at each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Participants with abnormal clinically significant vital signs findings is presented. It was assessed on Screening, Day -1, 1, 2 (pre-dose, 1, 3, 4, 6, 10, 16 and 24 hours of each treatment period) and Follow-up (7 to10 days after final discharge).|Up to Week 10.|Safety Population.|||Participants|||Count of Participants
2717445|NCT01119846|Primary|Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve-lead ECGs was obtained in a supine position at each time point during the study using an ECG machine that automatically measured PR, QRS, QT and QTc intervals (QT duration corrected for heart rate by Bazett's formula [QTcB] and Fridericia's formula [QTcF]). Participants with abnormal clinically significant ECG findings is presented. It was assessed on Screening, Day 1 at pre-dose, 1, 2, 3, 4, 6, 10, 16, 24 hours and Follow-up (7 to 10 days after final discharge).|Up to Week 10|Safety Population.|||Participants|||Count of Participants
2717446|NCT01119846|Primary|Part A: Number of Participants With Abnormal Clinical Chemistry Parameters of PCI|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total and direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, glucose fasting, gamma glutamyltransferase (GGT), albumin, sodium, magnesium, phosphorus inorganic, calcium, total carbon dioxide (CO2), alkaline phosphatase (ALP), triglycerides, total cholesterol, low-density lipoprotein (LDL) cholesterol, free fatty acid (non-esterified fatty acids; [NEFA]), high-density lipoprotein (HDL) cholesterol and total protein. It was assessed on Screening, Day -1, Day 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 10|Safety Population.|||Participants|||Count of Participants
2717447|NCT01119846|Primary|Part A: Number of Participants With Abnormal Hematology Parameters of Potential Clinical Importance (PCI)|Hematology parameters included platelet count, red blood cell (RBC) count, mean corpuscular volume (MCV), total neutrophils, white blood cell count (WBC; absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit, reticulocytes and basophils. It was assessed on Screening, Day -1, Day 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters (hemoglobin, high) for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 10|Safety Population.|||Participants|||Count of Participants
2717448|NCT01119846|Primary|Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 10|Safety Population comprised of all participants enrolled in the study and who had received at least one dose of study drug.|||Participants|||Count of Participants
2717449|NCT01119794|Primary|Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment|"Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only.~Complete Response - CR:~• Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~Partial Response - PR:~• At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~Stable Disease - SD:~• A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease~Relapsed Disease:~• Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis."|Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years|8/10 patients were evaluable as 2 withdrew|||participants|||Number
2717450|NCT01119768|Secondary|Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|16 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.|||percentage of participants|||Number
2717451|NCT01119768|Secondary|Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|8 weeks|Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment|||percentage of participants|||Number
2717452|NCT01119768|Secondary|Percentage of Patients Satisfaction|Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.|24 weeks after end of treatment|MITT|||percentage of participants|||Number
2717453|NCT01119768|Secondary|Number of Patients With Unscheduled Hospital Visit(s)||from baseline to week 24 after end of treatment|MITT|||participants|||Number
2717454|NCT01119768|Secondary|Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|2 and 8 weeks|ITT in 8 weeks treatment group|||percentage of participants|||Number
2717455|NCT01119768|Secondary|Symptom Relief Rate in 2 Treatment Regimens.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|8 weeks for arm 1, 2 weeks for arm 2|ITT was defined as all randomized subjects who took at least one dose of treatment.|||percentage of participans|||Number
2717456|NCT01119768|Secondary|Time to First Relapse.|"Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.~Time to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint"|From baseline to 24 weeks after end of treatment|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.|||days||Inter-Quartile Range|Median
2717457|NCT01119768|Secondary|The Success Rate in Whole Study Duration.|Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.|24 weeks after end of treatment|Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.|||percentage of participants|||Number
2717458|NCT01119768|Primary|Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|24 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment|||percentage of participants|||Number
2717459|NCT01119755|Secondary|Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
2717460|NCT01119755|Secondary|Mean Difference of Systolic Home Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
2717461|NCT01119755|Secondary|Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
2717462|NCT01119755|Primary|Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
2717463|NCT01119755|Primary|Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter|Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period|1 year||||mmHg||Standard Deviation|Mean
2717464|NCT01119755|Primary|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period|1 year||||mmHg||Standard Deviation|Mean
2717465|NCT01119755|Secondary|Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
2717466|NCT01119755|Primary|Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.|Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period|1 year||||mmHg||Standard Deviation|Mean
2717467|NCT01119716|Primary|Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation||up to 60 days from day of treatment (cardioversion)|All enrolled participants with follow-up data available|||Participants|||Number
2717468|NCT01119716|Primary|Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion|Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.|At time of treatment (up to 1 day from admission)|Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion.|||Percentage of Participants|||Number
2717469|NCT01119716|Primary|Treatments Utilized for Participants for Atrial Fibrillation||At time of Treatment (up to 1 day from admission)|All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.|||Participants|||Number
2717473|NCT01119703|Secondary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717474|NCT01119703|Secondary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717475|NCT01119703|Secondary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717476|NCT01119703|Secondary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717477|NCT01119703|Primary|Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln)."|3 weeks or 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717478|NCT01119703|Primary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717618|NCT01118663|Secondary|To Evaluate the Incidence of Anaphylactoid Reaction.|Data analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|1 hour||||participants|||Number
2717479|NCT01119703|Primary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717480|NCT01119703|Primary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717481|NCT01119703|Primary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
2717482|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2717483|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2717484|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
2717485|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2717486|NCT01119625|Secondary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
2717487|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2717619|NCT01118663|Secondary|To Evaluate the Incidence of Treatment Emergent Adverse Events||21-42 hours||||Number of Events|||Number
2717488|NCT01119625|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2717489|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||Titers||95% Confidence Interval|Geometric Mean
2717490|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2717491|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||EU/mL||95% Confidence Interval|Geometric Mean
2717492|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2717493|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2717494|NCT01119625|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||2099-12-31|12/2099||||
2717495|NCT01119625|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||2099-12-31|12/2099||||
2717496|NCT01119625|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.|||Participants|||Count of Participants
2717497|NCT01119625|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|"Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 31 days (Days 0-30) after booster vaccination|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.|||Participants|||Count of Participants
2717498|NCT01119625|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).~Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.~Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.|||Participants|||Count of Participants
2718682|NCT01110252|Secondary|Arterial Blood Gases Test - Pa O2|presence of oxygen in the blood gases.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure.|||mmHg||Standard Deviation|Mean
2717499|NCT01119625|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.|||Participants|||Count of Participants
2717500|NCT01119625|Primary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||EU/mL||95% Confidence Interval|Geometric Mean
2717501|NCT01119625|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2717502|NCT01119508|Primary|6-Month Progression-Free Survival (PFS) Rate|6-month progression free survival rate is defined as the number of participants without progression per RECIST 1.0 6 months after starting study treatment.|6 Months||||participants|||Number
2717503|NCT01119456|Other Pre-specified|Number of Participants Who Died|The number of participants who died is reported by cause of death.|Baseline through study completion (up to 52 weeks)|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2717504|NCT01119456|Secondary|Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)|Response was defined using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v 1.1) criteria. CR was the disappearance of all target and nontarget lesions; and any pathological lymph node (whether target or nontarget) must have had a reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of nontarget lesions. The disappearance of any intratumoral arterial enhancement in all target lesions was also required. PR was having at least a 30% decrease in sum of longest diameter of target lesions. PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir and the unequivocal progression of existing nontarget lesions. SD was small changes that did not meet the above criteria.|Baseline to measured PD (up to 48 weeks)|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2717505|NCT01119456|Secondary|Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8)|The expression of RON8 was measured in cell membrane/cytoplasm by immunohistochemistry (IHC) methods that incorporated both intensity and distribution of staining. The H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from a minimum score of 0 to a maximum score of 300; the maximum score indicated the strongest expression. Pharmacodynamic samples were collected per protocol and individual sampling times varied depending on the treatment group.|Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks)|Participants who received at least 1 dose of study drug and had tumor tissue samples.|||units on a scale||Full Range|Median
2717506|NCT01119456|Secondary|Immunogenicity of IMC-RON8|An immunogenicity assay for IMC-RON8 was not developed due to the decision to not further develop IMC-RON8 based on preliminary results of this study.|Prior to first infusion through study completion (up to 52 weeks)|Zero participants analyzed. Immunogenicity data were not collected.||||||
2717507|NCT01119456|Secondary|PK: Area Under the Curve (AUC) of IMC-RON8|The AUC from time 0 to the last quantifiable concentration [AUC(0-tlast)] of IMC-RON8 following the first IV infusion is reported along with the AUC for 1 dosing interval (AUC tau). Tau = fourth infusion through 168 hours post infusion for the qw regimen and the fifth infusion through 336 hours post infusion for the q2w regimen. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for AUC(0-tlast) or AUC tau.|First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose|Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for AUC(0-tlast) or AUC tau. No participant was analyzed for the geometric mean (%CV) of AUC tau in the 15, 20, 30, and 40 q2w treatment arms.|||micrograms*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2717508|NCT01119456|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8|The Cmax of IMC-RON8 following the first and multiple IV infusions (the fourth infusion for the qw treatment regimen and the fifth infusion for the q2w treatment regimen) is reported. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for Cmax.|First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose|Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for Cmax. No participant was analyzed for the geometric mean (%CV) of Cmax after multiple infusions in the 15, 20, 30, and 40 q2w treatment arms.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2717509|NCT01119456|Primary|Maximum Tolerated Dose (MTD) of IMC-RON8|The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting >7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).|Baseline through end of study treatment (up to 48 weeks)|Participants who received at least 1 dose of study drug.|||mg/kg|||Number
2717510|NCT01119443|Secondary|MRTpo,ss (Fasted Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
2717511|NCT01119443|Secondary|t1/2,ss (Fasted Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
2717512|NCT01119443|Secondary|λz,ss (Fasted Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||/hour||Standard Deviation|Geometric Mean
2717513|NCT01119443|Secondary|Tmax,ss (Fasted Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Full Range|Mean
2717514|NCT01119443|Secondary|Cmin,ss (Fasted Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
2717515|NCT01119443|Secondary|Cτ,ss (Fasted Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Error|Geometric Mean
2717516|NCT01119443|Primary|Cmax,ss (Fasted Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
2717517|NCT01119443|Primary|AUCτ,ss (Fasted Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
2717518|NCT01119443|Secondary|MRTpo,ss (Fed Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
2717519|NCT01119443|Secondary|t1/2,ss (Fed Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
2717520|NCT01119443|Secondary|λz,ss (Fed Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||per hour||Standard Deviation|Geometric Mean
2717521|NCT01119443|Secondary|Tmax,ss (Fed Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Full Range|Mean
2717522|NCT01119443|Secondary|Cmin,ss (Fed Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
2717523|NCT01119443|Secondary|Cτ,ss (Fed Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Error|Geometric Mean
2717526|NCT01119287|Primary|Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo|Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison.|Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)|Number of subjects with data available in the specific treatment group|||hours x units on a scale||Standard Deviation|Mean
2717527|NCT01119287|Primary|Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo|Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison.|Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)|Number of subjects with data available in the specific treatment group|||hours x units on a scale||Standard Deviation|Mean
2717528|NCT01119248|Secondary|Relationship Between Body Surface Area (BSA) and Change in Body Temperature After MRI|Bivariate analysis between BSA and change in body temperature after MRI. Reported is the change in body temperature after MRI with 1m2 increase in BSA, after adjusting type of MRI and duration of MRI. A positive change value reflects increase in body temperature with an increase in BSA and vice versa|Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours|120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient|||celsius degrees||95% Confidence Interval|Number
2717529|NCT01119248|Secondary|Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI|Bivariate analysis between pre MRI body temperature and change in body temperature after MRI. Body temperature of the subjects was measured with MRI compatible Tempadot. Reported is the change in body temperature after MRI with 1 degree increase in body temperature between subjects after adjusting for body surface area (BSA), type of MRI and duration of MRI. A positive change value reflects a child who was 1 degree C warmer experienced greater warming. The negative change reflects that a child who was 1 degree C warmer experienced greater cooling.|Prior to start of general anesthesia and immediately after completion of MRI an average of two hours|120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient|||celsius degrees||95% Confidence Interval|Mean
2717530|NCT01119248|Primary|Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI|Axillary temperature was measured with MRI-compatible Tempa dot immediately before general anesthesia was induced. Second axillary temperature reading was taken at the conclusion of the MRI scan before emergence from general anesthesia. Room temperature was measured with a digital thermometer placed in scanner room outside the magnet range.|prior to induction of general anesthesia and at conclusion of MRI an average of two hours|120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient|||celsius degrees||Full Range|Mean
2717531|NCT01119222|Secondary|Number of Participants With Abnormal Pulse Oxymetry Results|Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).|Predose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although pulse oxymetry was performed throughout IV dosing, results were not captured for inclusion in the study database.|||participants|||Number
2717532|NCT01119222|Secondary|Number of Participants With Abnormal Cardiac Monitoring Results|Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).|Pre-dose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although continuous cardiac monitoring was performed throughout IV dosing, results were not captured for inclusion in the study database.|||participants|||Number
2717533|NCT01119222|Secondary|Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results|Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.|Pre-dose, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.|||particpants|||Number
2717534|NCT01119222|Secondary|Number of Participants With Abnormal Findings on Electrocardiogram (ECG)|Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.|||participants|||Number
2717535|NCT01119222|Secondary|Number of Participants With Clinically Significant Abnormal Findings on Physical Examination|Full physical examination consisting of an examination of the abdomen, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected, results were not captured for inclusion in the study database.|||participants|||Number
2717620|NCT01118663|Secondary|To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|42 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.||||||
2717536|NCT01119222|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Supine blood pressure measured to nearest millimeter of mercury (mmHg), pulse rate measured with automated device or manually in the brachial/radial artery for at least 30 seconds.|Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.|||participants|||Number
2717537|NCT01119222|Primary|Interpolated Average Pain (0-8 Hours)|Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.|Pre-dose to 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.|||hours||Standard Error|Least Squares Mean
2717538|NCT01119222|Primary|Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)|"Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of no pain (0) to maximum pain (100) at the anchor endpoints of the scale and moderate pain at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec."|Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.|||mm||Standard Deviation|Mean
2717539|NCT01119131|Secondary|Change in Parkinsonism as Measured by the UPDRS|This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson's disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms.|Baseline, 16 weeks|Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1).|||units on a scale||Standard Deviation|Mean
2717540|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).|||foot pounds||Standard Deviation|Mean
2717541|NCT01119131|Primary|Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).|||units on a scale||Standard Deviation|Mean
2717542|NCT01119131|Secondary|Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)|"The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 (Never) to 4 (Always/Cannot Do). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson's disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life."|Baseline, 16 weeks|Missing data (N = 3), patient forgot form and did not return mailed form (N = 3).|||units on a scale||Standard Deviation|Mean
2717543|NCT01119131|Secondary|Change in Cognition (Trail Making Test B-A)|The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning.|Baseline, 16 weeks|Missing data (N = 8) due to scheduling difficulties (N = 3), neuropsychological administration errors (N = 2), patient discontinuing (N = 1), maximum time allowance met and discontinued test (N = 2).|||seconds||Standard Deviation|Mean
2717544|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).|||foot pounds||Standard Deviation|Mean
2717545|NCT01119131|Primary|Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration|"This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for ON time in Parkinson's disease. Change score is measurement at 16 weeks minus measurement at baseline."|Baseline and 16 weeks|Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).|||seconds||Standard Deviation|Mean
2717546|NCT01119131|Primary|Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=2, test not performed due to participant fatigue.|||units on a scale||Standard Deviation|Mean
2717547|NCT01119118|Secondary|Number of Subjects With PSA Response||6 months||||participants|||Number
2717548|NCT01119118|Secondary|Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone||Week 6||||participants|||Number
2717549|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone||Week 6||||participants|||Number
2717550|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.||Week 6||||participants|||Number
2717551|NCT01119118|Primary|The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.|Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.|Week 6||||participants|||Number
2717552|NCT01119040|Primary|Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.|Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.|30 day follow-up|Only 1 subject due to low accrual|||participants|||Number
2717553|NCT01119001|Primary|Accuracy of Typing With a BCI Keyboard by ALS Patients.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.~Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|3 times over 2-4 weeks||||percentage accuracy||Full Range|Mean
2717554|NCT01118988|Secondary|Positive and Negative Affect Scale (PANAS)|"assesses extent to which children have felt a number of positive and negative affects~Positive Affect subscale, 12 items, range: 12-60, higher score = more positive affect Negative Affect subscale, 15 items, range: 15-75, higher score = more negative affect"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717555|NCT01118988|Secondary|Child Health Questionnaire - Child Report (CHQ)|"detailed questionnaire about health, daily activites, pain, behavior, family health, self-esteem~Subscales (for all subscales, higher scores = better health):~Behavior - 16 items, averaged, range 1-5 Bodily Pain and Discomfort - 2 items, averaged, range 1-6 Change in Health - 1 item, range 1-5 Family Activities - 6 items, averaged, range 1-5 Family Cohesion - 1 item, range 1-5 Global Health - 1 item, range 1-5 Global Behavior - 1 item, range 1-5 General Health - 12 items, averaged, range 1-5 Mental Health - 16 items, averaged, range 1-5 Physical Functioning - 9 items, averaged, range 1-4 Role/Social Limitations Behavioral - 3 items, range 1-4 Role/Social Limitations Emotional - 3 items, range 1-4 Role/Social Limitations Physical - 3 items, range 1-4 Self-Esteem - 14 items, range 1-5"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717556|NCT01118988|Secondary|Beck Depression Inventory 2 (BDI-2) #18|"assesses suicidal ideation and intent~Number reported is number of participants who reported any level of suicidal ideation or intent at any time and who were followed with the study's emergency protocol to ensure that such participants are not a threat to self or others, and that he/she was under the appropriate mental health care."|baseline, weekly weeks 1-8, 2 months, 4 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||participants|||Number
2717557|NCT01118988|Secondary|Revised Child Anxiety and Depression Scale (RCADS) Child Report|"assess levels of symptoms for anxiety disorders and depression~Range: 0-141; Higher scores mean higher symptom level of anxiety and depression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717558|NCT01118988|Secondary|Functional Disability Inventory (FDI)|"assesses functional disability for daily tasks~Range: 0-60; higher scores mean greater functional disability."|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717559|NCT01118988|Secondary|Emotion Expression Scale for Children (EESC)|"assess child emotional expression/emotion regulation~Poor Awareness subscale, 8 items, range: 8-40; higher scores = poorer emotional awareness Expressive Reluctance subscale, 8 items, range: 8-40; higher scores = more expressive reluctance"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717560|NCT01118988|Secondary|Emotion Regulation Questionnaire (ERQ) - Child Answer|"assessment of child emotion regulation~Reappraisal subscale: 6 items, range 6-30, higher scores = higher use of reappraisal Suppression subscale: 4 items, range: 4-20, higher scores = higher use of suppression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717561|NCT01118988|Secondary|Health Belief Scale (HBS) Short Version - Child Report|Number of treatment modalities rated 1-4 by participants on the HBS questionnaire, which asked participants to rate how much they think each of 16 listed treatment modalities would help with pain (1=Completely, 2=A lot, 3=Some, 4=A little, 5=Not at all).|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||Number of treatments||Standard Deviation|Mean
2717562|NCT01118988|Secondary|Child Anxiety Sensitivity Inventory (CASI) - Child Report|"Assessment of child's anxiety sensitivity~18 items, range 18-54, higher scores = more anxiety sensitivity"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717563|NCT01118988|Secondary|Child Symptom Inventory (CSI)|"Assement of somatic symptom complaints~24 items, range 0-96, higher score = more somatic symptoms"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717564|NCT01118988|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"assessment of sleep quality~Range: 0-21; higher scores = lower sleep quality"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
2717565|NCT01118988|Secondary|Body Map and Pain Assessment|"visual depiction of body pain and associated pain ratings over certain periods of time and conditional situations~Range: 0-19 body areas"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||Number of painful body areas||Standard Deviation|Mean
2717566|NCT01118988|Primary|Adherence to Physician Recommended CAM Therapies|This measure tracks the attendance of CAM therapies recommended by the subjects' pain specialist physician.|post intervention (week 8)|One participant in the Mentorship group did not do the weekly CAM therapy tracking and is thus not included in the results for this measure.|||Visits to CAM therapists per week||Standard Deviation|Mean
2717567|NCT01118975|Primary|Clinical Benefit Rate|The Clinical Benefit Rate is the number of patients with either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for ≥ 6 months|Radiological evaluations are performed every 12 weeks to determine disease status||||participants|||Number
2717568|NCT01118975|Primary|Dose Limiting Toxicities|Safety and tolerability were assessed. Adverse events and dose limiting toxicities were recorded during an escalting dose pilot phase.|6 weeks||||Dose limiting toxicities|||Number
2717569|NCT01118962|Primary|Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."|||participants|||Number
2717570|NCT01118962|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."|||participants|||Number
2717571|NCT01118949|Secondary|Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.|||participants|||Number
2717572|NCT01118949|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.|||participants|||Number
2717573|NCT01118949|Secondary|Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.|||1/hour||Standard Deviation|Mean
2717574|NCT01118949|Secondary|Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.|||1/hour||Standard Deviation|Mean
2717575|NCT01118949|Primary|Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:~Seizure type~Seizure frequency~A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.|||number of seizure days||Standard Deviation|Mean
2718683|NCT01110252|Primary|Forced Expiratory Volume (FEV1)|A pulmonary function test that measures the volume and speed of the exhaled air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure|||liters||Standard Deviation|Mean
2717576|NCT01118949|Primary|Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:~Seizure type~Seizure frequency~A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.|||number of seizure days||Standard Deviation|Mean
2717577|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
2717578|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng・h/mL||Standard Deviation|Mean
2717579|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
2717580|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng/mL||Standard Deviation|Mean
2717581|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
2717582|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng・h/mL||Standard Deviation|Mean
2717583|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
2717584|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng/mL||Standard Deviation|Mean
2717585|NCT01118845|Secondary|Concomitant Medication Usage||up to 30 weeks||||Participants|||Number
2717586|NCT01118845|Secondary|Number of Subjects With Grade ≥3 Physical Examination Finding||up to 30 weeks||||Participants|||Number
2717587|NCT01118845|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).~grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event"|up to 30 weeks||||Participants|||Number
2717588|NCT01118845|Secondary|Number of Adverse Events||up to 30 weeks||||Events|||Number
2717589|NCT01118845|Secondary|Number of Subjects With Adverse Event||up to 30 weeks||||Participants|||Number
2717590|NCT01118845|Secondary|Progression Free Survival (PFS)|"PFS = day of the first PFS event - day of start of study treatment + 1~The definitions of PFS event are as below.~PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma~PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) >1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement~Disease progression during treatment period~Disease progression during follow up period~Start of treatment of new lesion~Occurrence of other multiple malignant tumors~Death"|up to 30 weeks||||Days||95% Confidence Interval|Median
2717591|NCT01118845|Secondary|The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"The criteria for CR is as below~Nodal Masses:~fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative~Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT)~Spleen, Liver:~Not palpable, nodules disappeared~Bone Marrow:~Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative"|up to 30 weeks||||Percentage of participants||95% Confidence Interval|Number
2717592|NCT01118845|Primary|The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites.~For the criteria for CR, See Outcome measure 2 description.~The criteria for PR is as below.~Nodal Masses:~more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT~Spleen, Liver:~more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen~Bone Marrow:~Irrelevant if positive prior to therapy; cell type should be specified"|up to 30 weeks||||Percentage of Participants||95% Confidence Interval|Number
2717593|NCT01118780|Secondary|Time to First Improvement|The time (days) to first improvement, defined as a Clinical Global Impression of Improvement (CGI-Improvement) Score ≤2. Participants who did not have a CGI-I Score ≤2 were censored at the last treatment period visit. CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). A CGI-Improvement Score of ≤2 was much improved or very much improved.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=37 participants in the duloxetine treatment arm and n=58 participants in the placebo treatment arm.|||days||95% Confidence Interval|Median
2717594|NCT01118780|Secondary|Time to First Functional Remission|Time (days) to first functional remission. Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). Participants, who did not have an SDS Global Score ≤5 or ≤6, were censored at the last treatment period visit. The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Baseline through 10 weeks|All randomized participants (pts). Number of pts censored (n)=50 pts in duloxetine treatment arm and n=73 pts in placebo treatment arm for time to first functional remission (SDS Global Score ≤5) and n=37 pts in duloxetine treatment arm and n=60 pts in placebo treatment arm time to first functional remission (SDS Global Score ≤6).|||days||95% Confidence Interval|Median
2717595|NCT01118780|Secondary|Time to Sustained Improvement Overall|Time (days) to the earliest visit at which the Hamilton Anxiety Rating Scale (HAMA) Total Score was a ≥30% improvement (reduction) from baseline that was sustained through the last treatment period visit. Participants who did not meet sustained improvement criteria were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=43 participants in the duloxetine treatment arm and n=63 participants in the placebo treatment arm.|||days||95% Confidence Interval|Median
2717596|NCT01118780|Secondary|Time to First Remission|The time (days) to first remission. Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score, were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). Participants who did not have remission were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants (pts). The number of censored pts (n)=72 pts in the duloxetine treatment arm and n=92 pts in the placebo treatment arm for time to first remission (HAMA Total Score ≤7) and n=49 pts in the duloxetine treatment arm and n=71 pts in the placebo treatment arm for the time to first remission (HAMA Total Score ≤10).|||days||95% Confidence Interval|Median
2717597|NCT01118780|Secondary|Time to First Response|The time (days) to first response, defined as a ≥50% improvement (reduction) from baseline in the Hamilton Anxiety Rating Scale (HAMA) Total Score. Participants who did not have a response were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of censored participants (n)=36 participants in the duloxetine treatment arm and n=60 participants in the placebo treatment arm.|||days||95% Confidence Interval|Median
2717598|NCT01118780|Other Pre-specified|Number of Participants Experiencing a Treatment-Emergent Adverse Event (AE) During the Taper Period|Treatment-emergent AEs were newly occurring AEs or a worsening of AEs during the taper period. A summary of serious AEs and other AEs during the treatment period (baseline through 10 weeks) is located in the Reported Adverse Events module.|2 weeks during the taper period|Randomized participants who entered the taper period.|||participants|||Number
2717599|NCT01118780|Secondary|Percentage of Participants Reporting Falling Down|The percentage of participants who reported 1 or more falls at or before Week 10.|Baseline through 10 weeks|Randomized participants with no falls recorded at Baseline and at least 1 post-baseline assessment for falls.|||percentage of participants|||Number
2717600|NCT01118780|Secondary|Adverse Events (AEs) Leading to Discontinuation From Study|The number of participants who discontinued from the study due to an AE (serious or other AE) during the treatment period. A summary of serious and other AEs is located in the Reported Adverse Events module.|Baseline through 10 weeks|All randomized participants.|||participants|||Number
2717601|NCT01118780|Secondary|Percentage of Participants With Sustained Improvement (Sustained Improvement Rate)|Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score at endpoint compared with baseline, were used to determine sustained improvement: Definition 1 [sustained improvement overall required a ≥30% improvement (reduction) in the HAMA Total Score at treatment period endpoint, at an earlier visit prior to endpoint, and at all visits in between] and Definition 2 (sustained improvement from Week 2 required a ≥30% reduction at treatment period endpoint, at Week 2, and at all visits in between). Both definitions required at least 2 post-baseline visits. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|(Baseline through 10 weeks) and (Baseline, Week 2 through Week 10)|Randomized participants who had baseline and the required number of post-baseline HAMA Total Scores.|||percentage of participants|||Number
2717621|NCT01118663|Secondary|To Evaluate the Percentage of Subjects Requiring Continued Therapy|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.||||||
2717682|NCT01118273|Secondary|Global Assessment of Study Medication as a Sleep-aid|Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717602|NCT01118780|Secondary|Percentage of Participants With Functional Remission at Week 10 (Functional Remission Rate)|Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Week 10|All randomized participants with at least 1 post-baseline SDS Global Score; Last observation carried forward (LOCF).|||percentage of participants|||Number
2717603|NCT01118780|Secondary|Percentage of Participants With Response or Remission at Week 10 (Response and Remission Rates)|Response was a ≥50% improvement (reduction) in the Hamilton Anxiety Rating Scale (HAMA) Total Score at treatment period endpoint compared with baseline. Two definitions were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline, Week 10|Randomized participants with a baseline and 1 post-baseline HAMA Total Score; Last observation carried forward (LOCF).|||percentage of participants|||Number
2717604|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Work/School, Social Life, and Family/Home Management Individual Impairment Scores|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Work/School, Social Life/Leisure Activities, or Family/Home Management Individual Impairment Scores.|||units on a scale||Standard Error|Least Squares Mean
2717605|NCT01118780|Secondary|Number of Participants With Treatment-Emergent Suicide-Related Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent was the worsening or new occurrence of suicidal behavior or ideation during treatment compared with baseline (Week 0)."|Baseline through 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS Score.|||participants|||Number
2717606|NCT01118780|Secondary|Change From Baseline to Week 10 in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Score|The Q-LES-Q-SF was a participant-rated questionnaire designed to assess the degree of enjoyment and satisfaction experienced during the past week. The questionnaire consisted of 16 items rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total raw score was the sum of Items 1 to 14 and could have ranged from 14 to 70. Total raw scores were converted to, and expressed as, the percentage of the maximum possible score. Percent=100*(total raw score - 14)/56. Higher scores indicated higher levels of enjoyment/satisfaction. Least squares (LS) mean were calculated and analyzed using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator, age category, and baseline.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; Last observation carried forward (LOCF).|||percent of maximum possible score||Standard Error|Least Squares Mean
2717607|NCT01118780|Secondary|Change From Baseline to Week 10 in Brief Pain Inventory-Modified Short Form (BPI-SF) Pain Severity and Interference Subscales|The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions assessing worst pain, least pain, and average pain in the past 24 hours, and pain right now. The BPI-SF Interference Subscale measured the interference of pain with the participant's ability to function. Interference scores could have ranged from 0 (does not interfere) to 10 (completely interferes) for questions assessing interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least squares (LS) means were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline BPI-SF Pain Severity or Interference Subscale Score.|||units on a scale||Standard Error|Least Squares Mean
2717608|NCT01118780|Secondary|Patient's Global Impressions of Improvement Scale (PGI-Improvement) at Week 10|PGI-Improvement measured the participant's perception of his or her improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much better) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline PGI-Improvement Score.|||units on a scale||Standard Error|Least Squares Mean
2717609|NCT01118780|Secondary|Clinical Global Impressions of Improvement Scale (CGI-Improvement) at Week 10|CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline CGI-Improvement Score.|||units on a scale||Standard Error|Least Squares Mean
2717610|NCT01118780|Secondary|Change From Baseline to Week 10 Endpoint in Hospital Anxiety Depression Scale (HADS) Subscale Scores|HADS was a 14-item questionnaire with 2 subscales (anxiety and depression). Each item was rated on a 4-point scale (0 to 3) and higher scores indicated a greater dysfunction. The HADS Anxiety Subscale Score was the sum of the odd numbered items and scores could have ranged from 0 to 21. The HADS Depression Subscale Score was the sum of the even numbered items and scores could have ranged from 0 to 21. Higher scores indicated a greater dysfunction. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HADS Subscale Score.|||units on a scale||Standard Error|Least Squares Mean
2717611|NCT01118780|Secondary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor Score, Somatic Anxiety Factor Score, and Individual Item Scores: Anxious Mood Item and Tension Item)|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Psychic Anxiety Factor Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28. The HAMA Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28. The HAMA Anxious Mood Item Score was the score for Item 1 and the HAMA Tension Item Score was the score for Item 2. In each case, higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA factor or item score.|||units on a scale||Standard Error|Least Squares Mean
2717612|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Global Functional Impairment Score.|||units on a scale||Standard Error|Least Squares Mean
2717613|NCT01118780|Primary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA Total Score.|||units on a scale||Standard Error|Least Squares Mean
2717614|NCT01118741|Secondary|Clinical Response|"To assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy. Reported as number of participants with PSA progression by 6 months.~Criteria used to assess: A rise in PSA noted at 6 months, greater than 50% over PSA value at baseline and > 2 ng/ml, above the nadir. The rise was confirmed by a second PSA value obtained at least 1 week from that reference value."|Up to 6 months||||participants|||Number
2717615|NCT01118741|Primary|Proportion of Subjects With a Demethylation Response at Each Dose Level|For both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a >=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.|24 months||||proportion of participants||95% Confidence Interval|Number
2717616|NCT01118728|Secondary|Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)|Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness).|Baseline up to the end of treatment (60 weeks)|Analysis was performed on safety population. Number of participants analyzed=participants with ASAS20 assessment at specified time-points. Here 'n' signifies number of participants with available data for specified time-point.|||Percentage of participants|||Number
2717617|NCT01118728|Primary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).|Baseline up to the end of study (66 weeks)|Analysis was performed on safety population defined as all participants who received at least one dose of the study treatment after signature of the informed consent.|||Percentage of participants|||Number
2717679|NCT01118273|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717622|NCT01118663|Primary|The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.||||||
2717623|NCT01118624|Secondary|Incidence of Adverse Events (AEs) and Laboratory Abnormalities||Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).||||participants|||Number
2717624|NCT01118624|Secondary|Overall Survival (OS)|Number of days from first dose of pralatrexate to death.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate.||||months||95% Confidence Interval|Median
2717625|NCT01118624|Secondary|Duration of Response (DOR)|One patient has a PR as response and duration of response was provided for that patient.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.||||days|||Number
2717626|NCT01118624|Primary|Objective Response Rate (ORR)|Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.||||participants|||Number
2717627|NCT01118455|Secondary|Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks||||participants|||Number
2717628|NCT01118455|Secondary|Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks|"Number of participants with any definite related Adverse Event by body system and preferred term, Safety Population.~NOTE: Number of participants analyzed in VNS arm includes one explant not from ITT population, but from safety population."|||Participants|||Number
2717629|NCT01118455|Secondary|Mean Percent Change in Seizure Frequency (ITT Population)|"The mean percent change in seizure frequency for the VNS and AED treatment groups at 52 weeks post baseline.~Both AED and VNS treatment groups were stratified according to the patients' number of previous AED treatments (early group had 2 to 5 AEDs tested to tolerance or to blood levels at upper end of target range; non-early group had more than 5 AEDs tested to tolerance or to blood levels at upper end of target range). Seizure frequency was calculated based on number of patient/caregiver reported seizures at 52-week post baseline (percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%). All seizures were counted.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|52 weeks post baseline||||Percent Change||Standard Deviation|Mean
2717630|NCT01118455|Secondary|Hague Restriction in Childhood Epilepsy Scale (Questionnaire B) (ITT Population)|"Calculate changes in the Hague Restriction in Childhood Epilepsy scale (Carpay et al. 1997) (Questionnaire B) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.~An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.~Total range for this scale is a minimum score of 10 to a maximum score of 40. There are no applicable subscales."|52 weeks post baseline||||Scores on a Scale||Standard Deviation|Mean
2717631|NCT01118455|Secondary|Wellcome Quality of Life Assessment (Questionnaire A) in Epilepsy (ITT Population)|"Calculate changes in the Wellcome Quality of Life Assessment (Parker et al. 1999) (Questionnaire A) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.~An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.~Total range for this scale is a minimum score of 81 to a maximum score of 336. There are no applicable subscales."|52 weeks post baseline||||Scores on a Scale||Standard Deviation|Mean
2717632|NCT01118455|Secondary|Mean Percent Change in Hague Seizure Severity Scale Score (ITT Population)|The Hague Seizure Severity Assessment (Carpay et al. 1996) is a scale completed by the patient and/or caregiver to assess the severity and post-ictal recovery of seizures. A reduction in the HSSA score reflects less seizure severity experienced.|52 weeks post baseline||||Percent Change||Standard Deviation|Mean
2717633|NCT01118455|Primary|Proportion of Responders After 1 Year of Follow-up (ITT-population)|Responders are subjects who had no new AEDs added or significant dose changes in baseline AEDs within 1 year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%.|52 weeks post baseline|Subjects were stratified based on AED therapy history (Early: treated with 2 to 5 AEDs versus Non-early: treated with >5 AEDs).|||percentage of responders|||Number
2717680|NCT01118273|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717634|NCT01118377|Secondary|Percentage of Participants With a Tumor Response|Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.|||Percentage of participants||95% Confidence Interval|Number
2717635|NCT01118377|Secondary|Overall Survival|Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.|||Months||95% Confidence Interval|Median
2717636|NCT01118377|Primary|Progression-free Survival|Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.|||Months||95% Confidence Interval|Median
2717637|NCT01118351|Other Pre-specified|Angiogenesis|The secondary outcome measure of response for the correlative studies will be the degree of apoptosis and the overexpression or not of known angiogenic markers (i.e. VEGF-R2, PDGF-R) an comparison by IHC analysis within bladder tumor tissue from the TURBT biopsy specimens with the post sunitinib (Sutent®) treatment TURBT specimens.|at 12 months after completion of treatment|||||||
2717638|NCT01118351|Other Pre-specified|Immune Response|The secondary outcome measure of response for the correlative studies will be the degree of apoptosis and the overexpression or not of known angiogenic markers (i.e. VEGF-R2, PDGF-R) an comparison by IHC analysis within bladder tumor tissue from the TURBT biopsy specimens with the post sunitinib (Sutent®) treatment TURBT specimens.|at 12 months after completion of treatment|||||||
2717639|NCT01118351|Secondary|Toxicity Assessed, Graded, and Tabulated Using CTCAE Version 3.0|Number of participants that experienced adverse events.|at 12 months after completion of treatment|All participants that received treatment|||Participants|||Count of Participants
2717640|NCT01118351|Secondary|Overall Survival|Number of patients still alive from date of registration to date of death due to any cause.|at 12 months after completion of treatment|All patients that received treatment and completed follow up.|||Participants|||Count of Participants
2717641|NCT01118351|Secondary|Progression-free Survival|Number of patients last known to be alive and not to have progressed are censored at the last day of contact. Progression is defined as: Biopsy proven muscle invasive disease ≥ Stage T2 or death due to any cause.|at 12 months after completion of treatment|All patients who received treatment and completed follow up.|||Participants|||Count of Participants
2717642|NCT01118351|Secondary|Recurrence-free Survival|Time from registration (up to 28 days prior to treatment) to the first documentation of recurrence assessed up to 12 months after completion of treatment (up to 12 weeks). Time period can be up to 16 months from time of registration.|at 12 months after completion of treatment|Patients that received treatment and completed follow up.|||months||Full Range|Median
2717643|NCT01118351|Primary|Complete Response Rate|Number of patients with complete response defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.|At 12 months after completion of treatment|All patients who received treatment and completed the 12 month follow up.|||Participants|||Count of Participants
2717644|NCT01118325|Secondary|AR-C124910XX (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||hour||Full Range|Median
2717645|NCT01118325|Secondary|AR-C124910XX (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||ng.h/mL||Standard Deviation|Geometric Mean
2717646|NCT01118325|Secondary|AR-C124910XX (Cmax) at Week 4|Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||ng/mL||Standard Deviation|Geometric Mean
2717647|NCT01118325|Secondary|AZD6140 (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||hour||Full Range|Median
2717648|NCT01118325|Secondary|AZD6140 (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||ng.h/mL||Standard Deviation|Geometric Mean
2717649|NCT01118325|Secondary|AZD6140 (Cmax) at Week 4|Maximum plasma AZD6140 concentration|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis|||ng/mL||Standard Deviation|Geometric Mean
2717650|NCT01118325|Primary|IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
2717651|NCT01118325|Primary|IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
2717652|NCT01118325|Primary|IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
2717653|NCT01118325|Primary|IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
2717654|NCT01118325|Primary|Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
2717655|NCT01118312|Secondary|Childhood Asthma Control Test|Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control|24 weeks|Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores|||units on a scale||Standard Error|Mean
2717656|NCT01118312|Primary|Asthma Control Test (ACT)|Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control|24 weeks|Analysis of adult (18 and above) Asthma Control Scores|||units on a scale||Standard Error|Mean
2717657|NCT01118299|Primary|Effectiveness Endpoint - Device Arm Only|"Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).~However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol."|Randomization through 2 year follow up|No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm.|||events|||Number
2717658|NCT01118299|Primary|Long-term Safety - Device Arm Only|"All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).~However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol."|Randomization to 2 year follow-up|No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm.|||Events|||Number
2717659|NCT01118299|Primary|Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only|"An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques.~The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).~However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol."|From Randomization to Discharge Visit|No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm.|||events|||Number
2717660|NCT01118273|Secondary|Wake Episode Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).|Up to 10 hours||||Wake episodes||95% Confidence Interval|Least Squares Mean
2717661|NCT01118273|Secondary|Activity Mean Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Activity mean - average movement per minute.|Up to 10 hours|ITT (Intent to Treat) Population|||Movement per minute||95% Confidence Interval|Least Squares Mean
2717662|NCT01118273|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Percentage of sleep time||95% Confidence Interval|Least Squares Mean
2717663|NCT01118273|Secondary|Total Wake Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2717664|NCT01118273|Secondary|Number of Times Participants Took Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
2717665|NCT01118273|Secondary|Global Assessment of Study Medication as a Pain Reliever|Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
2717666|NCT01118273|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
2717667|NCT01118273|Secondary|Time to Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment."|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
2717668|NCT01118273|Secondary|Overall Rating of Pain Relief|"Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
2717669|NCT01118273|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score|Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2717670|NCT01118273|Secondary|Overall Rating of Severity in Visual Analog Scale (VAS) Score|Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.|At 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
2717671|NCT01118273|Secondary|Change From Baseline in Categorical Pain Rating Scale Score|Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2717672|NCT01118273|Secondary|Overall Rating of Severity in Categorical Pain Rating Scale Score|Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).|Up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
2717673|NCT01118273|Secondary|Sleep Quality Index|Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2717674|NCT01118273|Secondary|Total Sleep Time by Subject Assessment|Subject responded to: Please estimate the number of hours and minutes you think that you slept.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2717675|NCT01118273|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717676|NCT01118273|Secondary|Karolinska Sleep Diary - Well Rested|Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717677|NCT01118273|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717678|NCT01118273|Secondary|Karolinska Sleep Diary - Premature Awakening|Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2717683|NCT01118273|Secondary|Sleep Latency Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2717684|NCT01118273|Secondary|Wake After Sleep Onset (WASO) Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2717685|NCT01118273|Primary|Total Sleep Time Measured by Actigraphy|"Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as awake from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero."|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2717686|NCT01118221|Secondary|Maximum Oxygen Uptake|Change in 6 peak O2 uptake from Baseline to 3 Months|Maximum O2 uptake will be measured at 0 and 3 months.||||mL/minute||Standard Error|Mean
2717687|NCT01118221|Secondary|Systemic Markers of Oxidant Stress|Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.|Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.||||pg/mL||Standard Deviation|Mean
2717688|NCT01118221|Primary|6 Minute Walk Distance|Change in 6 Minute Walk Distance from Baseline to 3 Months|The 6-MWD will be measured at 0 and 3 months.||||meters||Standard Deviation|Mean
2717689|NCT01118143|Secondary|Plaque Index|"The plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque.~The Plaque index reference is Silness and Löe, 1964."|6 months after intervention||||units on a scale||Standard Deviation|Mean
2717690|NCT01118143|Primary|Gingival Index|The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.|6 months after intervention||||units on a scale||Standard Deviation|Mean
2717691|NCT01118117|Secondary|Stent Fracture at 12 Months|Occurrence of stent fracture as determined by core laboratory analysis|12 Months post-procedure|X-rays for 324 stents (234 subjects) were available for analysis by the angiographic core laboratory to evaluate stent fractures at 12 months post-procedure. One stent fracture was caused by a physician during a non-study peripheral intervention.|||percentage of fracture occurrence|stents||Number
2717692|NCT01118117|Secondary|Major Adverse Events (MAEs) Through 12 Months Post-procedure|The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.|12 Months post-procedure||||percentage of subjects with event|||Number
2717693|NCT01118117|Secondary|Clinical Success|Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline|30 days post-procedure||||percentage of subjects with success|||Number
2717694|NCT01118117|Secondary|Procedural Success|Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel|Intra-procedure||||percentage of subjects with success|||Number
2717695|NCT01118117|Secondary|Technical Success|"Technical Success defined by the following conditions:~Successful delivery of the stent at the lesion site~Stent(s) successfully deployed in lesion with adequate lesion coverage"|Intra-procedure|All subjects enrolled in pivotal trial|||percentage of subjects with success|||Number
2717696|NCT01118117|Secondary|Device Related Peri-Procedural Complications|Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)|Prior to Hosptial Discharge|All enrolled participants evaluated prior to hospital discharge|||percentage of subjects with event|||Number
2717697|NCT01118117|Secondary|Occurrence of Target Lesion Revascularization|"The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.~Clinically driven defined as:~More than 50 percent stenosis with worsening symptoms, OR~More than 70 percent stenosis without symptoms"|12 Months post-procedure|Comprised of all subjects enrolled in the pivotal OSPREY trial (N=261)|||percentage of subjects with TLR|||Number
2717698|NCT01118117|Secondary|Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort|The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)|12 Months post-procedure|Analysis uses a more contemporary approach to evaluate primary stent patency using a peak systolic velocity ratio ≤ 2.4 (modified VIVA criteria). Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success in the analysis.|||percentage of stent patency|||Number
2717714|NCT01118013|Primary|Event-free Survival (EFS)|EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.|Duration of study (up to 5.5 years)|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
2717699|NCT01118117|Primary|Primary Safety Endpoint|The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.|30 days post-procedure|Study success was based on the proportion of patients with freedom from MAE at 30 days post-procedure when tested against a performance goal of 88% using the lower bound of the 95% confidence interval. In both cohorts, the lower confidence interval exceeded the prespecified performance goal indicating the study met its primary safety endpoint.|||percentage of subjects without a MAE||95% Confidence Interval|Number
2717700|NCT01118117|Secondary|Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort|Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).|12 Months post-procedure|The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).|||percentage of stent patency|||Number
2717701|NCT01118117|Primary|Primary Effectiveness Endpoint|The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.|12 Months post-procedure|Analysis comprised of 261 subjects enrolled in pivotal trial and missing data imputed as loss of patency under the intention-to-treat (ITT) analysis. Study success was based on the proportion of patients with stent patency when tested against a performance goal of 66% using the lower bound of the 95% confidence interval.|||percentage of stent patency||95% Confidence Interval|Number
2717702|NCT01118091|Primary|Progression Free Survival|Measured from the time of randomization to time of progression (or death).|3 years||||Days|||Number
2717703|NCT01118091|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years||||Participants|||Number
2717704|NCT01118091|Primary|Response Rate|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 years||||Participants|||Number
2717705|NCT01118052|Secondary|Progression-free Survival|The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.|The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years|Eligible and treated patients|||months||90% Confidence Interval|Median
2717706|NCT01118052|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 years|Eligible and treated patients|||months||90% Confidence Interval|Median
2717707|NCT01118052|Primary|Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0|Adverse events are listed by adverse event and grade. The number of participants affected is listed.|All Adverse Events (AEs) deemed at least possibly related to study treatmetn occurring during treatment and up to 30 days after stopping the study treatment. for up to 5 years after stopping study treatment|Eligible and evaluable patients|||Participants|||Count of Participants
2717708|NCT01118052|Primary|Patients Who Have Objective Tumor Response (Complete or Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|CT or MRI used to follow lesion for measurable disease every other cycle. Patient's best response while on study treatment was recorded, Up to 5 years|Eligible and Treated patients|||percentage of participants||90% Confidence Interval|Number
2717709|NCT01118052|Primary|Patients Who Survive Progression-free for at Least 6 Months|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression|Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
2717710|NCT01118013|Secondary|Rate of Opportunistic Infections|Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.|1 year post transplant|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
2717711|NCT01118013|Secondary|Overall Survival|Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 5.5 years|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
2717712|NCT01118013|Secondary|Complete Response Rate|Complete response (CR) rate is reported as the percentage of participants who achieved a CR.|Up to 5.5 years|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
2717713|NCT01118013|Primary|Comparison of EFS Distribution to That of CALGB-100002|EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.|2 years|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
2717746|NCT01117623|Secondary|Biomarker Soluble Vascular Endothelial Growth Factor Receptor 2 (sCEGFR-2) Plasma Levels|The analysis of Biomarker sCEGFR-2 plasma levels is not done.|No data obtained|ITT||||||
2717715|NCT01117987|Secondary|Percentage of Participants With Incidence of Clinical Worsening Events|Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.|204 weeks|Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.|||Percentage of participants|||Number
2717716|NCT01117987|Secondary|Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)|A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).|core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks|Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.|||meters||Standard Deviation|Mean
2717717|NCT01117987|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|204 weeks|Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.|||Participants|||Number
2717718|NCT01117948|Secondary|Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI||6 months double-blind, 6 months open label (optional)|||||||
2717719|NCT01117948|Primary|Cognitive Performance - ADAS-cog+|"Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items).~Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind)."|6 months double blind, 6 months open-label (optional)||||units on a scale||Standard Deviation|Mean
2717720|NCT01117870|Secondary|Number of Participants Who Discontinued Analgesics After Intervention|Number of PRF treatment patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group.|4 weeks|Number of participants who discontinued analgesics after intervention|||Participants|||Count of Participants
2717721|NCT01117870|Secondary|Change in Oswestry Disability Index (ODI) From Baseline to 4 Week|ODI is an index derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to: care for oneself, walk, sit, sexual function, stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|baseline (at recruitment) and at 4 weeks|Success defined as at least 50% improvement in Oswestry Disability Index (ODI) - measured at 4 weeks compared to placebo group.|||percentage change of ODI||Standard Deviation|Mean
2717722|NCT01117870|Secondary|Assessment of Side Effects|Percentage of patients having side effects after PRF treatment assessed at 1 week compared to placebo group. Assessment of persisting side effects, percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment|1 week and up to 3 months|Assessment of persisting side effects and percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment|||percentage of participants|||Number
2717723|NCT01117870|Secondary|Change in Mean Visual Analogue Scale (VAS) Scores From Baseline to 4 Weeks|"Secondary outcomes were considered as exploratory. Is PRF an effective treatment for patients with CLR pain? It will be measured by a change in VAS scores from baseline measurement at recruitment.~Visual analog scale (VAS) - For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10) on a 10-cm scale."|baseline (at recruitment) and at 4 Weeks|Intent to treat analysis was used.|||units on a scale||Standard Deviation|Mean
2717724|NCT01117870|Primary|Number of Participants Lost to Follow-up at 3 Months|Patients who were lost to follow-up at 3 months were recorded.|3 months||||Participants|||Count of Participants
2717725|NCT01117870|Primary|Recruitment Rate|Expected recruitment is at least 4 patients per month. At least 80% of eligible patients fulfilling the selection criteria can be recruited. The final assessment was at the end of 15 months, at which time all the subjects were enrolled. Participants withdrawing within 4 weeks after the interventional shall not be included in the study. However participants withdrawing after 4 weeks of the intervention shall be included in the final analysis, on intention to treat principle.|15 month point|Patients with suspected leg pain were initially approached by the research assistant. Further screening for eligibility was done in the presence of the physician. Suitable patients met with the research assistant (blind to intervention), who noted down the baseline parameters of the patient after obtaining an informed consent.|||Participants|||Count of Participants
2717726|NCT01117857|Other Pre-specified|Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)|The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
2717727|NCT01117857|Other Pre-specified|Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
2717728|NCT01117857|Other Pre-specified|Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)|The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
2717729|NCT01117857|Secondary|Change in Menopause Symptoms as Measured by the Greene Climacteric Scale|The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
2717730|NCT01117857|Primary|Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression|The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
2717731|NCT01117766|Secondary|Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7|NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 4 (Visits 4 and 7) of each period|FAS. n=18, 18; number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
2717732|NCT01117766|Secondary|Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7|"Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to How intense is your pain today?"|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
2717733|NCT01117766|Secondary|Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7|PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
2717734|NCT01117766|Secondary|Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7|Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF).|||scores on a scale||Standard Deviation|Mean
2717735|NCT01117766|Primary|Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.|||scores on a scale||Standard Deviation|Mean
2717736|NCT01117766|Primary|Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.|||scores on a scale||Standard Deviation|Mean
2717737|NCT01117766|Primary|Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||cm2||Standard Deviation|Mean
2717738|NCT01117766|Primary|Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.|||scores on a scale||Standard Deviation|Mean
2717739|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7|Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||cm2||Standard Deviation|Mean
2717740|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7|"Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a strange or tickly sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score."|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|Full analysis set (FAS)=participants with present pain intensity score >=4 out of 10 for brush evoked allodynia at screening and randomization, >=4 out of 7 non missing values in week prior to randomization, >4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
2717741|NCT01117727|Primary|Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning|Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .|8 sessions over 2 months||||percent of correct targets selected|||Number
2717742|NCT01117623|Other Pre-specified|Tumor Response in Expansion Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only|||Participants|||Number
2717743|NCT01117623|Other Pre-specified|Tumor Response in Dose Escalation Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set)|||Participants|||Number
2717744|NCT01117623|Other Pre-specified|Tumor Progression in Expansion Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only|||Participants|||Number
2717745|NCT01117623|Other Pre-specified|Tumor Progression in Dose Escalation Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|Intent-to-treat (ITT) efficacy analysis (set)|||Participants|||Number
2717748|NCT01117623|Secondary|Ratio of AUCt,ss/AUC (RLIN)|RLIN is the ratio of the measure of systemic drug exposure at steady state to the measure of systemic drug exposure after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|PK population; Number of Participants with an evaluable AUCt,ss and AUC in at least one analyte were 0 in 20mg; 3 (regorafenib) and 4 (M2) in 40mg; 3 in 100 mg; 2 (regorafenib) and 0 (M2) in 120 mg; 3 (regorafenib) and 2 (M2) in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 4 in NSCLC; No participants have evaluable data for M5.|||Ratio|||Number
2717749|NCT01117623|Secondary|Ratio of AUCt,ss/AUCt (RAAUC)|RAAUC is the ratio of the measure of systemic drug exposure over a specific dosing interval at steady state to the measure of systemic drug exposure over a specific dosing interval after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUCt,ss and AUCt in at least one analyte were 0 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||Ratio|||Number
2717750|NCT01117623|Secondary|Ratio of Cmin,ss/Cmin (RACmin)|RACmin is the ratio of the lowest drug concentration at steady state to the lowest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmin,ss and Cmin in at least one analyte were 0 (M5) in 20mg; 6 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||Ratio|||Number
2717751|NCT01117623|Secondary|Ratio of Cmax,ss/Cmax (RACmax)|RACmax is the ratio of the highest drug concentration at steady state to the highest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss and Cmax in at least one analyte were 1 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||Ratio|||Number
2717752|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)|Tmax,ss refers to the time after multiple dose administration and after a steady state concentration has been reached when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Tmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||h||Full Range|Median
2717753|NCT01117623|Secondary|AUC From Time 0 to 24 Hours at Steady State Divided by Dose (AUC(0-24)ss/D)|AUC(0-24)ss/D is a measure of systemic drug exposure (AUC) over 24 hours after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24)ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||h/L||Geometric Coefficient of Variation|Geometric Mean
2717754|NCT01117623|Secondary|Cmax at Steady State During a Dosing Interval Divided by Dose (Cmax,ss/D)|Cmax,ss/D refers to the highest measured drug concentration after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||1/L||Geometric Coefficient of Variation|Geometric Mean
2717755|NCT01117623|Secondary|Half-life Associated With the Terminal Slope (T1/2)|T1/2 is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|PK population; Number of Patients with at least an evaluable T1/2 were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (regorafenib and M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10(M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC|||h||Geometric Coefficient of Variation|Geometric Mean
2717756|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Tmax in at least one analyte were 1 (M-5) in 20 mg; 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M-5) in NSCLC|||h||Full Range|Median
2717757|NCT01117623|Secondary|Maximum Observed Plasma Concentration After Single Dose Administration Divided by Dose (Cmax/D)|Cmax/D refers to the highest measured drug concentration after a single dose administration, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax/D in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC|||1/L||Geometric Coefficient of Variation|Geometric Mean
2717758|NCT01117623|Secondary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose Divided by Dose (AUC/D)|The AUC/D is a measure of systemic drug exposure (AUC) after the first single dose, which is then divided by that dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC/D were 5 (regorafenib) and 6 (M-2) in 40mg; 5 (regorafenib and M-2) in 100 mg; 3 (M-2) in 120 mg; 6 (regorafenib and M-2) in 140 mg; 9 (regorafenib), 10 (M-2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M-2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M-2) in NSCLC|||h/L||Geometric Coefficient of Variation|Geometric Mean
2717759|NCT01117623|Secondary|AUC From Time 0 to the Last Data Point > Lower Limit of Quantification (LLOQ) (AUC(0-tlast))|The AUC(0-tlast) is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-tlast) in at least one analyte were 1(M-5) in 20mg; 7 (regorafenib and M-2) and 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M5) in NSCLC|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2717760|NCT01117623|Primary|AUC From Time 0 to 24 Hours at Steady State(AUC(0-24),ss)|AUC(0-24),ss is a measure of systemic drug exposure over 24 hours, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24),ss in at least one analyte in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2717761|NCT01117623|Primary|Cmax at Steady State During a Dosing Interval (Cmax,ss)|Cmax,ss refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2717762|NCT01117623|Primary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose (AUC)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10 (M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2717763|NCT01117623|Primary|Maximum Observed Plasma Concentration After Single Dose Administration (Cmax)|Cmax refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2717764|NCT01117623|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level, which could be given to 6 participants such that no more than 1 participant (less than 33%) experienced a dose-limiting toxicity (DLT).|Within first 4 weeks of treatment|Safety Population; dose escalation cohorts only|||mg|||Number
2717765|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)|The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.|||units on a scale||Standard Deviation|Mean
2717890|NCT01116102|Secondary|Technical Challenges Encountered During Fluid Infusion|Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems|at any occurence of a defined challenge or at end of infusion if no challenges occurred|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)|||participants|||Number
2717766|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.|||units on a scale||Standard Deviation|Mean
2717767|NCT01117480|Primary|Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.|||percentage of participants|||Number
2717768|NCT01117454|Primary|Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing|Hypothesis: the addition of oral flecainide to standard therapy will reduce ventricular ectopy and/or VT on treadmill exercise treadmill testing in patients with CPVT, compared to placebo plus standard therapy.|3 months|1 participant did not complete treadmill test|||Participants|||Count of Participants
2717769|NCT01117428|Secondary|Terminal Half-Life (T½)|"For Part A, the endpoint was not calculated. For Parts B, C and F, the endpoint was calculated for each patient following the first and fourth Sym004 infusions.~For Parts D and E, the endpoint was calculated for each patient following the first and third Sym004 infusions.~T½ was estimated using non-compartmental methods and actual time points.~Outcome Measure Time Frame:~Parts B, C and F (Weekly dosing): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) until 1 week post-infusion (168-hours) and at Visit 5 (4th dose from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 1 week post-infusion (168-hours).~Parts D, E (Dosing every second week): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) to end of 3rd dose (from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 2 weeks post-infusion (336 hours)."|See Time Frame in the Outcome Measure Description|For Part A, data could not be reported as the endpoint was not calculated and no pharmacokinetics (PK) analysis set was defined. For Parts B to F, a PK analysis set was used.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2717770|NCT01117428|Secondary|Antitumor Activity Endpoints - Time-to-event Endpoints|"Median Progression Free Survival (PFS) was defined as the time interval without PD from start of first infusion until death or documented PD (i.e. at least a 20% increase in the sum of diameters of target lesions) according to RECIST v1.1. Patients who died without confirmed PD were considered as progressed. Patients who died or showed PD more than 21 days after last treatment were censored (i.e. were considered alive without progression on Day 21 after last treatment). Patients without events were censored at date of last scan or 22 days after last treatment, whichever occurred first.~Median Overall Survival (OS) was defined as the time from start of first infusion until date of death from any cause. Patients alive at the time of the analysis or prematurely withdrawn from the trial (e.g. lost to follow-up or consent withdrawn) were censored for the OS analysis. In any case of censoring, the date of censoring was the last time point documenting survival status."|Up to 62 weeks||||Months||95% Confidence Interval|Median
2717771|NCT01117428|Secondary|Antitumor Activity|Best Overall Response (OR) on the Full Analysis Set (FAS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, based on central evaluation with confirmatory CT scan or MRI [Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR): CR + PR]. Baseline was defined as Visit 2 (pre-infusion). The outcome measure was measured from screening until PD.|Up to 62 weeks|Data for Part A were presented only for the FAS. For Parts B to F, analyses and summaries were performed both for the FAS and for the per protocol population. The FAS was considered the primary analysis population.|||percentage of participants||95% Confidence Interval|Number
2717772|NCT01117428|Primary|Number of Participants With Adverse Events (AEs)|The AEs were used as a primary endpoint. AEs were summarized using descriptive statistics and presented overall by system organ class and preferred term. The frequencies of AEs were presented including number and percentages of participants with events and the total number of events.|Visit 2 until first follow-up visit (up to 66 weeks)||||Participants|||Count of Participants
2717773|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the extension period (from week 24 to week 48)|The population analyzed was the safety population (extension) i.e. all treated patients during the extension period.|||participants|||Number
2718684|NCT01110252|Primary|Forced Vital Capacity (FVC)|A pulmonary function test that measures the volume and speed of the inhalated air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure|||liters||Standard Deviation|Mean
2717774|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the comparative period (from week 0 to week 24)|The population analyzed was the safety population i.e. all randomized and treated patients.|||participants|||Number
2717775|NCT01117350|Secondary|Daily Dose of Insulin Glargine Administered During the Extension Period||week 30, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this mITT population were analyzed at each week.|||Unit (U)||Standard Deviation|Mean
2717776|NCT01117350|Secondary|Daily Dose of Liraglutide||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.|||mg||Standard Deviation|Mean
2717777|NCT01117350|Secondary|Daily Dose of Insulin Glargine||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.|||Unit (U)||Standard Deviation|Mean
2717778|NCT01117350|Secondary|Body Weight: Change From Beginning to End of the Extension Period|Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the mITT population (extension).|||kg||Standard Deviation|Mean
2717779|NCT01117350|Secondary|Body Weight: Change From Baseline to the End of the Comparative Period|Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline|baseline (week 0), week 2, week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one weight value on treatment during the comparative period.|||kg||Standard Deviation|Mean
2717780|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value"|week 24, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this population were analyzed for each time point of the profile.|||mg/dL||Standard Deviation|Mean
2717781|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value"|baseline (week 0), week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed for each time point of the profile.|||mg/dL||Standard Deviation|Mean
2717782|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value"|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT (extension) patients who had SMFPG value both at beginning of the extension and at least one value on treatment during the extension period.|||mg/dL||Standard Deviation|Mean
2717783|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value"|baseline (week 0), week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one SMFPG value on treatment during the comparative period.|||mg/dL||Standard Deviation|Mean
2717784|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period|Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)|week 36, week 48|The population analyzed for this outcome measure consisted of the mITT patients who had at least one HbA1c value on treatment during the extension period.|||percentage of participants|||Number
2717785|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period|Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value|week 24, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT population (extension) who had HbA1c value both at beginning of the extension and at least one value on treatment during the extension period.|||percent||Standard Deviation|Mean
2717786|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period|Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percent||Standard Deviation|Mean
2717787|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period|Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percentage of participants|||Number
2717788|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period|"Percentage of patients with:~* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value~AND~* HbA1c value at end of the comparative period (LOCF) ≥7%"|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percentage of participants|||Number
2717789|NCT01117350|Primary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period|The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).|week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percentage of participants|||Number
2717790|NCT01117337|Secondary|Seroma Formation|A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.|One year||||Participant|||Number
2717791|NCT01117337|Primary|Proportion of Patients Having Pain in the Post Operative Period|To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.|1 month||||Participant|||Number
2717792|NCT01117337|Primary|Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.|Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.|1 year||||Participant|||Number
2717793|NCT01117311|Secondary|Gastric Emptying Half-time|Gastric emptying half time is the time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested||||minutes||Standard Error|Mean
2717794|NCT01117311|Primary|Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|baseline, 2 weeks||||10^-14dl/kg/min^2 per pmol/l||Standard Error|Mean
2717795|NCT01117181|Secondary|Electrocardiogram (ECG)|Abnormal electrocardiogram results at 6 weeks|6 weeks||||participants with abnormal ECG|||Number
2717796|NCT01117181|Secondary|Electrolytes|Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory|6 weeks|One patient in the active group completed all visit 6 assessments except for the blood collection for the electrolyte sample. This patient refused this procedure.|||percentage of participants|||Number
2717797|NCT01117181|Secondary|Vital Status|vital status as measured by death|vital status at 6 weeks||||participants who died|||Number
2717798|NCT01117181|Secondary|Neuropsychiatric Inventory (NPI): Apathy Subscale|Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.|baseline to week 6||||units on a scale||Standard Error|Mean
2717799|NCT01117181|Secondary|Mini-Mental State Exam (MMSE)|Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.|baseline and 6 weeks||||units on a scale||Standard Error|Mean
2717800|NCT01117181|Secondary|Digit Span|Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale - Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning.|baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
2717801|NCT01117181|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change|"Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement."|baseline to 6 weeks||||percentage of participants who improve|||Number
2717802|NCT01117181|Primary|Apathy Evaluation Scale (AES)|Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.|baseline to 6 weeks||||units on a scale||Standard Error|Mean
2717803|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a valsalva maneuver|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the subject was unable to perform the valsalva, or if data were missing.|||mmHg||Standard Deviation|Mean
2717804|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a cough|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, or if the subject was unable to cough.|||mmHg||Standard Deviation|Mean
2717805|NCT01117090|Secondary|The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis|Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the clamp was not open, or if the resistance check data were missing.|||seconds||Standard Deviation|Mean
2717806|NCT01117090|Primary|Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, CSF signatures recorded in subjects who have an infusion system who present with signs and/or symptoms of possible catheter-related problems or failure.|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, or if there was an issue with the equipment|||Subjects whose CSF data agree with MD Dx|||Number
2717807|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 8||Week 8|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)|||ng/ml||Standard Deviation|Mean
2717808|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 2||Week 2|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)|||ng/ml||Standard Deviation|Mean
2717809|NCT01117051|Primary|Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week|A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.|12 weeks|Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication.|||percentage of subjects|||Number
2717810|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Weight Through Week 96|Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.|||kg||Standard Deviation|Mean
2717811|NCT01117012|Secondary|Annualized Duration of Pulmonary Exacerbation Events||Study 105: Day 1 through Week 96|Full Analysis Set.|||Days per year||Standard Deviation|Mean
2717812|NCT01117012|Secondary|Annualized Pulmonary Exacerbation Event Rate|Annualized event rate was calculated by regression with negative binomial distribution.|Study 105: Day 1 through Week 96|Full Analysis Set.|||events per year|||Number
2717813|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2717814|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.|||percent predicted of FEV1||Standard Deviation|Mean
2717815|NCT01117012|Secondary|Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.|Study 105: Baseline through Week 96|Full Analysis Set.|||percent predicted of FEV1 per year||95% Confidence Interval|Least Squares Mean
2717816|NCT01117012|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.|Study 105: Day 1 up to Week 168|Safety Set included all participants who received at least 1 dose of study drug during Study 105.|||participants|||Number
2717817|NCT01116986|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.~Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome."|16 weeks post-quit||||participants|||Number
2717818|NCT01116986|Secondary|Latency to Relapse|Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.|During the first 6 months post-quit||||participants|||Number
2717819|NCT01116934|Primary|Serum Concentrations of Interleukin (IL)-1 Beta|Concentrations of IL-8, IL-6, IP-10, interferon (IFN)-gamma, and IL-1 beta, in plasma/RPMI samples were determined by enzyme linked immunosorbent assay (ELISA) according to the manufacturers' instructions|2006|Samples were stimulated with 100 ng/ml lipopolysaccharide (LPS)|||pg/ml||Inter-Quartile Range|Median
2717820|NCT01116921|Secondary|Incidence of Chronic Lung Disease||Measured at hospital discharge||||Participants|||Count of Participants
2717821|NCT01116921|Secondary|Incidence of Severe IVH or PVL||During hospitalization||||Participants|||Count of Participants
2717822|NCT01116921|Secondary|Incidence of Pulmonary Airleaks||First 7 days of life||||Participants|||Count of Participants
2717823|NCT01116921|Secondary|Duration of Oxygen Therapy||During first seven days of life||||hours||Standard Deviation|Mean
2717824|NCT01116921|Secondary|Duration of CPAP Therapy||During first seven days of life||||hours||Standard Deviation|Mean
2717825|NCT01116921|Primary|Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.|"Treatment Failure criteria were the same for both groups. Treatment Failure required two of the following: 1) FiO2 >40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 >65mmHg on ABG/CBG or >70 on VBG, or 3) pH<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 >40%, or 4) deemed necessary by medical provider."|Seven days||||Participants|||Count of Participants
2717826|NCT01116895|Secondary|Participants With Satisfactory Response According to IGA|"Satisfactory response was defined as participants classified as Clear or Almost Clear or Mild according to the IGA."|At end of treatment (Day 84)||||Participants|||Count of Participants
2717827|NCT01116895|Secondary|"Participants With Controlled Disease According to the Investigators' Global Assessment (IGA)"|"At Visits 1 to 8 the investigator made a global assessment of the disease severity (IGA) using a 6-point scale (clear, almost clear, mild, moderate, severe, very severe). This assessment represents average lesion severity on head, trunk, arm and legs. The assessment was based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. Participants classified as clear or almost clear according to IGA was considered to have controlled disease."|At end of treatment (Day 84)||||Participants|||Count of Participants
2717828|NCT01116895|Secondary|Participants With at Least 50% Reduction in PASI (PASI 50)||From baseline (Day 0) to end of treatment (Day 84)||||Participants|||Count of Participants
2717829|NCT01116895|Secondary|Participants With at Least 75% Reduction in PASI (PASI 75)||From baseline (Day 0) to end of treatment (Day 84)||||Participants|||Count of Participants
2717830|NCT01116895|Primary|Percentage Change in Psoriasis Area and Severity Index (PASI)|"The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness.~The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale:~0. = no involvement~= <10%~= 10-29%~= 30-49%~= 50-69%~= 70-89%~= 90-100%~For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined.~PASI was calculated based on the investigator's assessment of the disease locally (head, trunk, arm, legs) using the following formula:~Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72."|Baseline (Day 0) to end of treatment (Day 84)|Full Analysis Set|||percentage of change in PASI index score||Standard Deviation|Mean
2717831|NCT01116882|Secondary|Any Repeat Revascularization||30 days|The denominator for any repeat revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.|||participants|||Number
2717832|NCT01116882|Secondary|Rate of Stent Thrombosis||30 days||||participants|||Number
2717833|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||12 months||||participants|||Number
2717834|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||30 days||||participants|||Number
2717835|NCT01116882|Secondary|All Cause Mortality at 12 Months||12 months||||participants|||Number
2717836|NCT01116882|Secondary|Met Indication Criteria for PCI|Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.|Post-Procedure||||lesions|Participants||Number
2717837|NCT01116882|Secondary|Complete Revascularization|Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.|Post-Procedure||||participants|||Number
2717838|NCT01116882|Secondary|Major Vascular Complications||30 days||||participants|||Number
2717839|NCT01116882|Secondary|Procedural Success|Procedural success is defined as residual stenosis of the target lesion of less than 20%|Post-Procedure||||participants|||Number
2717840|NCT01116882|Secondary|Emergency or Urgent Revascularization||30 days|The denominator for emergency or urgent revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.|||participants|||Number
2717849|NCT01116687|Secondary|Participant Progression Free Survival (PFS) Rate|Progression-Free Survival defined as the time from start of treatment until disease progression or death as a result of any cause. Patients were re-evaluated for response every 8 weeks. Response and progression were evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.|Study duration of 12 months|All evaluable participants|||months||95% Confidence Interval|Median
2717850|NCT01116687|Secondary|Participant Overall Survival (OS) Rate|Overall Survival defined as the time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. The Kaplan-Meier method was used to estimate all time-to-event functions. Statistical analysis was performed using Stata SE 9.0 software and SAS 9.2 software.|Study duration of 12 months|All evaluable participants|||months||95% Confidence Interval|Median
2717851|NCT01116687|Primary|Number of Participants With Objective Radiographic Response (ORR)|To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least 2 prior treatments in the metastatic setting. Radiologic assessment of tumor burden (CT scans of the chest, abdomen and pelvis, or MRI of the abdomen and pelvis and CT of the chest) was scheduled every 8 weeks. Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were used for evaluation of the primary endpoint.|2 months from enrollment for each participant|All evaluable participants|||participants|||Number
2717852|NCT01116661|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events, as defined by grade 3 to 5 AEs and SAEs related to study drug. .|14 days|Patients who received study drug|||Participants|||Count of Participants
2717853|NCT01116661|Primary|The Percentage of Biopsies Taken From the Most Fluorescent Tissues That Have Tumorous Content.|Biopsies were examined by a pathologist to determine the amount of tumor content from the most fluorescent tissues|1 day|All patient who received 5-Aminolevuline Acid prior to surgical resection|||percentage of biopsies||95% Confidence Interval|Median
2717854|NCT01116544|Secondary|Strength Test Extension|Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.|At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.||||Newton-meters||Inter-Quartile Range|Median
2717855|NCT01116544|Secondary|Strength Test Flexion|Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.|At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.||||Newton-meters||Inter-Quartile Range|Median
2717856|NCT01116544|Secondary|Stroke Impact Scale (Stroke Recovery)|A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.|Within a week of completing all training sessions.||||units on a scale||Standard Deviation|Mean
2717857|NCT01116544|Secondary|Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)|"Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions [scored from 1 (least impact) to 5 (most impact)]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed:~[(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range] X 100. The minimum transformed score is 0 and the maximum is 100."|Within a week of completing all training sessions.||||units on a scale||Standard Deviation|Mean
2717858|NCT01116544|Secondary|Fugl-Meyer (UL) Assessment|Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.|At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.|Chronic stroke with severe upper limb impairment|||units on a scale||Standard Deviation|Mean
2717859|NCT01116544|Primary|Box and Blocks Test|Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.|Within a week of completing all training sessions.|Chronic stroke with severe hand impairment|||Number of blocks moved||Inter-Quartile Range|Median
2717860|NCT01116466|Secondary|Change in MRI of Affected Leg and Implant Post-implantation|MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.)|Week 3 post-implantation|||||||
2717861|NCT01116466|Secondary|Nerve Conduction Velocity of the Peroneal Nerve|Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)|Baseline, week 12 post-implantation|Two subjects were unavailable for the test.|||m/s||Standard Deviation|Mean
2717862|NCT01116466|Secondary|Four Square Step Test (FSST)|It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation.|Baseline, week 12 post-implantation||||s||Standard Deviation|Mean
2717891|NCT01116102|Secondary|Cumulative Fluid Volume Delivered||each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)|||mL||Full Range|Mean
2717863|NCT01116466|Secondary|Canadian Occupational Performance Measure (COPM) Score|A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.|Baseline,12 weeks post-implantation|Two subjects were not available for the test.|||units on a scale||Standard Deviation|Mean
2717864|NCT01116466|Secondary|Walking Speed During 10 Meter Gait Test|The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation||||m/s||Standard Deviation|Mean
2717865|NCT01116466|Primary|Distance Walked in 6 Minutes|The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation||||m||Standard Deviation|Mean
2717866|NCT01116427|Secondary|Mean Change in the MSFC in Extension Phase|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week 24 to Week 52|Intent-to-treat in Extension Phase who Completed the MSFC at Week 52|||Scores on a scale||Standard Deviation|Mean
2717867|NCT01116427|Secondary|Annualized Relapse in Extension Phase|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.|Week 24 to Week 64|Intent-to-treat in Extension Phase|||Relapse Rate by Year|||Number
2717868|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week 24 to Week 64|Intent-to-treat in Extension Phase|||participants|||Number
2717869|NCT01116427|Secondary|Percent Brain Volume Change Between 24 Weeks and 52 Weeks|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52 with data to contribute to brain volume measurements|||Percent change||Standard Deviation|Mean
2717870|NCT01116427|Secondary|Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks|Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52|||cm^3||Standard Deviation|Mean
2717871|NCT01116427|Secondary|Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase|The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 36 and 52|Intent-to-treat in Extension Phase|||New Lesions||Standard Deviation|Mean
2717872|NCT01116427|Secondary|Mean Change in the MSFC Over 24 Weeks of Treatment|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week -1 to Week 24|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
2717873|NCT01116427|Secondary|Annualized Relapse Rate|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.|Week -1 to Week 24|Intent-to-treat|||Relapse Rate by Year|||Number
2717874|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week -1 to Week 24|Intent-to-treat|||participants|||Number
2717875|NCT01116427|Secondary|Mean Number of New Inflammatory Lesions in 8-week Intervals|The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Week 8 to Week 24|Intent-to-treat|||New Lesions||Standard Deviation|Mean
2717876|NCT01116427|Secondary|Percent Brain Volume Change|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24 and had MRI scans at both Week -1 and Week 24|||percent change||Standard Deviation|Mean
2717877|NCT01116427|Secondary|Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks|Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24|||cm^3||Standard Deviation|Mean
2717878|NCT01116427|Secondary|Absolute Number of New Inflammatory MRI Lesions on Monthly Scans|The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 4-24|Intent-to-treat|||New Lesions||Standard Deviation|Mean
2717879|NCT01116427|Primary|Mean Number of New Inflammatory MRI Lesions Per Monthly Scans|The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 8-24|Intent-to-treat|||New Lesions||Standard Deviation|Mean
2717880|NCT01116401|Secondary|Change in Montgomery-Asperg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score.|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2717881|NCT01116401|Primary|Percent Change in Wake After Sleep Onset (WASO)|Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.|baseline and 4 weeks||||percent change||95% Confidence Interval|Number
2717882|NCT01116232|Secondary|Immunocorrelative Studies Pre- and Periodically Post-transplantation||Using flow cytometry at 30, 60, 90, and 180 days post transplant.|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717883|NCT01116232|Secondary|Overall and Disease-free Survival||At 1 year|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717884|NCT01116232|Secondary|Incidence of Thrombotic Microangiopathy||Within 100 days of HCT|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717885|NCT01116232|Secondary|Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder||At one year|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717886|NCT01116232|Secondary|Incidence of Chronic GVHD||Within two years after transplant|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717887|NCT01116232|Primary|Safety Assessment||During the first six months post transplant|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717888|NCT01116232|Primary|Time to Engraftment||During the first six months post transplant|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717889|NCT01116232|Primary|Incidence and Severity of Acute Graft-vs-host Disease (GVHD)||During the first six months post transplant|Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.||||||
2717892|NCT01116102|Secondary|Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement||end of catheter/needle placement|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)|||Subjects|||Number
2717893|NCT01116102|Primary|Maximum Measured In-line Fluid Pressure|Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion|each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)|||psi||Full Range|Mean
2717894|NCT01116037|Secondary|Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.|Safety Analysis will be based on the the number of participants with cardiovascular complications.|Six Years||||participants|||Number
2717895|NCT01116037|Primary|Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000|Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.|Six Years||||Participants|||Count of Participants
2717896|NCT01116024|Primary|Hemodynamics - Effective Orifice Area Index|The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.|Five Years|At discharge Effective Orifice Area index data was collected for 61 subjects.|||EOAi (cm2/m2)||Standard Deviation|Mean
2717897|NCT01116024|Primary|Hemodynamics - Effective Orifice Area|"Effective orifice area (EOA) data.~The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve."|Five Years|At discharge Effective Orifice Area data was collected for 61 subjects.|||EOA (cm2)||Standard Deviation|Mean
2717898|NCT01116024|Primary|Hemodynamic|Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.|Five Years|At discharge, gradient data was collected of 103 subjects.|||mmHg||Standard Deviation|Mean
2717899|NCT01116024|Primary|Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance|"New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.~Class I: Patients with cardiac disease but without limitations of ordinary activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased."|Five Years||||participants|||Number
2717900|NCT01116024|Primary|Re-operation, Explant, Repair|"Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
2717901|NCT01116024|Primary|Non-Structural Dysfunction|"Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
2717902|NCT01116024|Primary|Structural Valve Deterioration|"Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation.~There were no cases of structural deterioration reported for the study.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year|||Number
2717903|NCT01116024|Primary|Hemolysis|Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves - as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis - is usually associated with paravalvular leakage or infection.|Five Years||||participants|||Number
2717904|NCT01116024|Primary|Endocarditis|"Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
2717905|NCT01116024|Primary|Paravalvular Leaks (All and Major)|"Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
2717906|NCT01116024|Primary|Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)|"Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy.~Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant):~Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
2717907|NCT01116024|Primary|Thromboembolism/Thrombosis|"Valve related thromboembolism and valvular thrombosis.~Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year)"|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
2719016|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
2717908|NCT01115998|Primary|Early Coping Inventory|We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.|||Units on scale||Inter-Quartile Range|Median
2717909|NCT01115998|Primary|Battelle Developmental Inventory (BDI)|Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.|||Units on scale||Inter-Quartile Range|Median
2717910|NCT01115998|Primary|Pediatric Evaluation of Disability Inventory|Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.|||Units on scale||Inter-Quartile Range|Median
2717911|NCT01115933|Secondary|Overall Stent Thrombosis|"Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."|0 - 298 days|FAS population|||percentage of participants|||Number
2717912|NCT01115933|Secondary|Late Stent Thrombosis|"Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."|31 - 298 days|FAS population|||percentage of participants|||Number
2717913|NCT01115933|Secondary|Acute/Subacute Stent Thrombosis|"Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."|0-30 days|FAS population|||percentage of participants|||Number
2717914|NCT01115933|Secondary|Subacute Stent Thrombosis|"Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."|1-30 days|FAS population|||percentage of participants|||Number
2717915|NCT01115933|Secondary|Acute Stent Thrombosis|"Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."|<24 hours|FAS population|||percentage of participants|||Number
2717916|NCT01115933|Secondary|All Coronary Revascularization||9 months|FAS population|||percentage of participants|||Number
2717917|NCT01115933|Secondary|All Coronary Revascularization||1 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717918|NCT01115933|Secondary|Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|9 months|FAS population|||percentage of participants|||Number
2717919|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717920|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).|1 month|FAS population|||percentage of participants|||Number
2717921|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717922|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717923|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717924|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717925|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2719017|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.|||hours||Full Range|Median
2717926|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717927|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717928|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
2717929|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population|||percentage of participants|||Number
2717930|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|FAS Population|||percentage of participants|||Number
2717931|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|"Any revascularization for in-segment restenosis will be considered TLR. Segment is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms."|9 months|FAS population|||percentage of participants|||Number
2717932|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|"Any revascularization for in-segment restenosis will be considered TLR. Segment is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms."|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
2717933|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|"Any revascularization for in-segment restenosis will be considered TLR. Segment is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms."|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717934|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|"Any revascularization for in-segment restenosis will be considered TLR. Segment is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms."|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
2717935|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|"Any revascularization for in-segment restenosis will be considered TLR. Segment is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms."|9 months|FAS Population|||percentage of participants|||Number
2717936|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|"Any revascularization for in-segment restenosis will be considered TLR.Segment is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms."|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
2717937|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2719018|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
2717938|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|FAS Population|||percentage of participants|||Number
2717939|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717940|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG~Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves~Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717941|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717942|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717943|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717944|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|"DEATH (Per ARC Circulation 2007; 115: 2344-2351)~All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac."|1 month||||percentage of participants|||Number
2717945|NCT01115933|Secondary|Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.~PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)|||percentage of participants||95% Confidence Interval|Number
2717946|NCT01115933|Secondary|Late Loss (LL), In-segment, In-stent, Proximal and Distal|"LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:~In-segment Late Loss: in-segment MLD post-procedure - in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure - in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)"|8 months|Full Analysis Set (FAS population)|||mm||Standard Deviation|Mean
2717947|NCT01115933|Secondary|Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.~PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)|||percentage of DS||Standard Deviation|Mean
2717948|NCT01115933|Secondary|Procedural Success(Subject Base Analysis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|ITT population|||percentage of participants||95% Confidence Interval|Number
2717949|NCT01115933|Secondary|Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)|Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|Intent to Treat Population (ITT)|||percentage of participants||95% Confidence Interval|Number
2719019|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 1|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
2717950|NCT01115933|Primary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)|9 Months|Full Analysis Set (FAS population)|||percentage of participants|||Number
2717951|NCT01115855|Secondary|Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|Specific activity scale was estimated by pre-specified questionnaire (for different activities) to assess the exercise capability of the participants. Answers provided by participants were transformed in terms of number of metabolic equivalents (METs).1 MET was defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml oxygen per kg body weight* minute. Scale ranged from 1 (less than (<) 2 METs) = lowest level of exercise tolerance to 6 (>=8METs) = highest level of tolerance and higher score indicated more tolerance.|Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||metabolic equivalents (METs)||Standard Deviation|Mean
2717952|NCT01115855|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|NYHA: classified as 'class I' (participants with cardiac disease but without resulting limitations of physical activity), 'class II' (participants with cardiac disease resulting in slight limitation of physical activity), 'class III' (participants with cardiac disease resulting in marked limitation of physical activity), 'class IV' (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as 'improved' (positive change), 'no change' or 'worsened' (negative change).|Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||participants|||Number
2717953|NCT01115855|Secondary|Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||microgram per gram creatinine (mg/gCr)||Standard Deviation|Mean
2717954|NCT01115855|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit|LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.|Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of LVEF||Standard Deviation|Mean
2717955|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||pg/mL||Standard Deviation|Mean
2717956|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||picogram/milliliter (pg/ml)||Standard Deviation|Mean
2717957|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization for Hyperkalemia|Hospitalization due to hyperkalemia (as per physician's decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717958|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function|Hospitalization due to worsening renal function (as per physician's decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717959|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Diabetes Mellitus|New onset diabetes mellitus was defined as the diagnosis of diabetes mellitus in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717960|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter|New onset of atrial fibrillation or flutter was defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717961|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717962|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717963|NCT01115855|Secondary|Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening|Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percent or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717964|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization|CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717965|NCT01115855|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization|HF mortality was defined as any death due to HF. Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717966|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717967|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)|Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717968|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717969|NCT01115855|Secondary|Number of Participants With With First Occurrence of Cardiovascular Mortality|CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717970|NCT01115855|Secondary|Number of Participants With With First Occurrence of All-Cause Mortality|All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Mortality during treatment, within 30 days of treatment discontinuation and after 30 days of discontinuation was reported. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717971|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717972|NCT01115855|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
2717973|NCT01115803|Other Pre-specified|Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation||Within 30 days of study drug discontinuation|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2717974|NCT01115803|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]|BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.|Baseline up to 112 Days|All participants who received at least 1 dose of study drug and assessed for BOR.|||Participants|||Count of Participants
2717975|NCT01115803|Secondary|Pharmacokinetics, Area Under the Concentration Time Curve (AUC)|AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).|Cycle 1 Days 1 (C1 D1) and Cycle 1 Day 8 (C1 D8) of 28-day cycle|All participants who received at least 1 dose of study drug and had AUC values.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2717976|NCT01115803|Secondary|Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702||Cycle 1 Day 1 (C1 D1): predose, 0.5, 1, 2, 3, 5, 8 hours postdose and Cycle 1 Day 8 (C1 D8): predose, 0.5, 1, 2, 3, 5, and 8 hours postdose of 28-day cycle|All participants who received at least 1 dose of study drug and had Cmax values.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2717977|NCT01115803|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]|Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Baseline to disease progression or death or up to 6 cycles of 28 days|All participants who received at least 1 dose of study drug and assessed for RR.|||percentage of participants||90% Confidence Interval|Number
2717978|NCT01115803|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.|Baseline to disease progression or death or up to 166 days postbaseline|Zero participants were analyzed as no data collected.||||||
2717979|NCT01115803|Secondary|Clinically Significant Effects (Number of Participants With Adverse Events)|Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.|Baseline up to 7 months|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2717980|NCT01115803|Primary|Recommended Dose for Phase 2 Studies|The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.|Baseline up to 6 cycles of 28 days|All participants who received at least 1 dose of study drug.|||milligrams (mg)|||Number
2717981|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|6 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had PRU measurements 6 hours after prasugrel LD and provided a DNA sample.|||PRU||Standard Error|Least Squares Mean
2717982|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|Baseline|All randomized participants who were treated with Clopidogrel and had PRU measurement at Baseline and provided a DNA sample.|||PRU||Standard Error|Least Squares Mean
2719035|NCT01107379|Secondary|Procedure Tolerability|Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.|Day 0 (Day of Procedure)|Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.|||number of participants|||Number
2717983|NCT01115738|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.|Baseline through 72 hours after prasugrel loading dose|Participants who received any treatment.|||participants|||Number
2717984|NCT01115738|Secondary|Percentage of Poor Responders|Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.|||percentage of participants|||Number
2717985|NCT01115738|Secondary|Percentage of Inhibition of Platelet Aggregation|Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.|||percentage of inhibition||Standard Error|Least Squares Mean
2717986|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hemoglobin measurement 72 hours after LD.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2717987|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hematocrit measurement 72 hours after LD.|||proportion of 1.0||Standard Deviation|Mean
2717988|NCT01115738|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had at least one evaluable PRU measurement after prasugrel LD.|||PRU||Standard Error|Least Squares Mean
2717989|NCT01115738|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|6 hours after prasugrel loading dose|All randomized participants who received the prasugrel LD and had at least one evaluable PRU measurement after LD.|||PRU||Standard Error|Least Squares Mean
2717990|NCT01115699|Secondary|Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)|"The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.~Screening test scoring ranges:~0-5, No Depression Likely~6-10, Possibly Mildly Depressed~11-15, Moderate Depression~16-20, Severe Depression~21 or Over, Very Severe Depression"|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.||||||
2717991|NCT01115699|Primary|Change in Hamilton Rating Scale for Depression (HRS-D17)|The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.||||||
2717992|NCT01115673|Secondary|Patient Global Evaluation|Patient Assessment of the Pain Medication - Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Units on a scale||Standard Error|Least Squares Mean
2717993|NCT01115673|Secondary|Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score|Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Percentage of Participants|||Number
2717994|NCT01115673|Secondary|Rescue Rates Through Six Hours|Percentage of subjects using rescue medication.|through 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Percentage of Participants|||Number
2717995|NCT01115673|Secondary|Rescue Rates Through Four Hours|Percentage of subjects using rescue medication.|through 4 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Percentage of Participants|||Number
2719253|NCT01105650|Secondary|Time to Disease Progression|Time from study entry until progressive disease or data collection cutoff.|1 Year|"Number of participants with progressive disease at one year:~Arm 1: 2 out of 3; Arm 2: 1 out of 3; Arm 3: 5 out of 7"|||days||Full Range|Median
2717996|NCT01115673|Secondary|Duration of Analgesia - Time to Rescue|Minutes until rescue medication was given.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Minutes||Full Range|Median
2717997|NCT01115673|Secondary|Time to Confirmed Perceptible Pain Relief|Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Minutes||Full Range|Median
2717998|NCT01115673|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Minutes||Full Range|Median
2717999|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718000|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718001|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718002|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718003|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718004|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718005|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718006|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718007|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718008|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718009|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718010|NCT01115673|Secondary|Pain Relief (PAR) Scores at 360 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718011|NCT01115673|Secondary|Pain Relief (PAR) Scores at 300 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718012|NCT01115673|Secondary|Pain Relief (PAR) Scores at 240 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718013|NCT01115673|Secondary|Pain Relief (PAR) Scores at 180 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718014|NCT01115673|Secondary|Pain Relief (PAR) Scores at 120 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718015|NCT01115673|Secondary|Pain Relief (PAR) Scores at 90 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718016|NCT01115673|Secondary|Pain Relief (PAR) Scores at 75 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718017|NCT01115673|Secondary|Pain Relief (PAR) Scores at 60 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718018|NCT01115673|Secondary|Pain Relief (PAR) Scores at 45 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718019|NCT01115673|Secondary|Pain Relief (PAR) Scores at 30 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718020|NCT01115673|Secondary|Pain Relief (PAR) Scores at 15 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718021|NCT01115673|Secondary|Pain Intensity Difference (PID) at 360 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718022|NCT01115673|Secondary|Pain Intensity Difference (PID) at 300 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718023|NCT01115673|Secondary|Pain Intensity Difference (PID) at 240 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718024|NCT01115673|Secondary|Pain Intensity Difference (PID) at 180 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718025|NCT01115673|Secondary|Pain Intensity Difference (PID) at 120 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718026|NCT01115673|Secondary|Pain Intensity Difference (PID) at 90 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718027|NCT01115673|Secondary|Pain Intensity Difference (PID) at 75 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718028|NCT01115673|Secondary|Pain Intensity Difference (PID) at 60 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718029|NCT01115673|Secondary|Pain Intensity Difference (PID) at 45 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718030|NCT01115673|Secondary|Pain Intensity Difference (PID) at 30 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718031|NCT01115673|Secondary|Pain Intensity Difference (PID) at 15 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718032|NCT01115673|Secondary|Sum of Pain Relief Scores Over Six Hours (TOTPAR6)|Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718033|NCT01115673|Secondary|Sum of Pain Intensity Difference Over Six Hours (SPID6)|Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718034|NCT01115673|Primary|Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)|Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
2718035|NCT01115660|Secondary|Follow up Appointment With MD|Follow up appointment with primary care provider since stroke|3 months|Patients who were contacted at 3 months|||participants|||Number
2718036|NCT01115660|Primary|Feasibility of Intervention (Ability to Reach Patients at 3 Months)|Number of patients contacted at 3 months|3 months|All eligible patients who also were available at 3 months for post-intervention follow-up call.|||number of patients contacted|||Number
2718037|NCT01115582|Secondary|Total Bilirubin|Concentration of total bilirubin in serum|At baseline and after 30 days of treatment|All patients entered and treated|||mg/dL||Standard Deviation|Mean
2718038|NCT01115582|Secondary|Physical Examination|Total number of patients with abnormal findings from general physical examination|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated|||participants|||Number
2718039|NCT01115582|Secondary|Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP)|At baseline and after 30 days of treatment|All patients entered and treated|||mmHg||Standard Deviation|Mean
2718040|NCT01115582|Secondary|Adverse Events|Total number of patients with any adverse events|Total of 30 days, i.e. from the time point the patients entered into the study up to the end of treatment|All patients entered and treated|||participants|||Number
2718041|NCT01115582|Primary|Serum and Urine Bile Acids|Concentration of bile acids in serum (S) and urine (U). (abbreviations: chol.=cholenoic; monohydro=monohydroxy; dihydro=monohydro)|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated|||mmol/L||Standard Deviation|Mean
2718042|NCT01115582|Primary|Serum Transaminases|Concentration of serum alanine transaminase (ALT) and aspartate transaminase (AST)|At baseline and after 30 days of treatment|All patients entered and treated|||U/L||Standard Deviation|Mean
2718043|NCT01115569|Secondary|Maintenance of Efficacy|Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication|1 year|||||||
2719289|NCT01105091|Primary|Body Weight - Baseline and Day 28|Body weight was measured both at baseline and day 28.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||kg||Full Range|Median
2718044|NCT01115569|Primary|Mean Change in Average Daily Pain|Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.|1 year|The number of participants for analysis was determined by the safety population. Numeric Rating Scale (NRS) for Pain assessment was used. Measure is mean change in average daily pain intensity. Total number of participants providing end of study pain intensity score = 391.|||units on a scale||Standard Deviation|Mean
2718045|NCT01115556|Secondary|Mean Change in Visual Acuity (VA) From Baseline at Month 12|"Mean change in Visual Acuity (VA) from Baseline at Month 12~Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12~Mean change in leakage as determined by FA at Months 6 and 12~Mean number of ranibizumab injections at Months 6 and 12~Mean time to first re-treatment following the initial 3 monthly loading doses~Mean duration of fluid-free interval~Safety and tolerability of 2.0mg using the incidence and severity of adverse events"|one year||||ETDRS Letters||Standard Deviation|Mean
2718046|NCT01115556|Primary|Mean Change in Visual Acuity (VA) From Baseline at Month 6||Baseline and 6 months||||ETDRS Letters||Standard Deviation|Mean
2718047|NCT01115517|Secondary|Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year||1 year||||participants|||Number
2718048|NCT01115517|Secondary|Number of Participants Who Had Complications From the Time of Treatment to Recurrence||1 year||||participants|||Number
2718049|NCT01115517|Primary|Number of Participants Who Had Recurrence of Pterygia up to 1 Year||1 year||||participants|||Number
2718050|NCT01115491|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population|||percentage of participants|||Number
2718051|NCT01115491|Primary|PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study||BL, 24 weeks (after 6th cycle)|ITT population|||survival probability|||Number
2718052|NCT01115491|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population|||weeks||95% Confidence Interval|Median
2718053|NCT01115491|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population|||percentage of participants|||Number
2718054|NCT01115491|Primary|PFS - Time to Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population|||weeks||95% Confidence Interval|Median
2718055|NCT01115491|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.|Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population|||percentage of participants|||Number
2718056|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718086|NCT01115101|Primary|Difference of Pain Scores on the Visual Analog Scale|"The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline.~For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain.~Single value were calculated (averaged)."|Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.|The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.|||VAS score at 24 hours||Standard Deviation|Mean
2718087|NCT01114997|Secondary|Post-anesthesia Care Unit (PACU) Stay||1 day||||Minutes||Standard Deviation|Mean
2718057|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718058|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718059|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718060|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718061|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718062|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated.|||units on a scale||95% Confidence Interval|Mean
2718063|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718088|NCT01114997|Secondary|Patient Satisfaction|Patient satisfaction using a verbal rating scale from 0 to 10 0= Not satisfied 10= Excellent|1 month||||Score on a scale||Standard Deviation|Mean
2718089|NCT01114997|Secondary|Return to Normal Activities of Daily Living Using Follow up Questionnaires|Description: return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)|1 month||||participants|||Number
2718064|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718065|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718066|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718067|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718068|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718069|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718070|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718090|NCT01114997|Secondary|Number of Participants With Postoperative Nausea One Day After Surgery|Postoperative nausea using a Verbal Rating Scale Outcomes measured at the first day after surgery|1day||||participants|||Number
2718091|NCT01114997|Secondary|Opioid Consumption Obtained From the Recorded Data|Postoperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|1 day|Opioid: Hydromorphone|||mg||Standard Deviation|Mean
2718071|NCT01115452|Primary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
2718072|NCT01115244|Secondary|Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score|Photographs of the treated and control extremity of each patient will be presented to the investigator in a blinded manner. Scores will be assigned according to a modified Global Acne Assessment Score. This scoring system has previously been used to evaluate the efficacy of dapsone gel, 5% in the treatment of acne. The designated score is based on disease severity, number of lesions, and type of lesions.|6 weeks of treatment|||||||
2718073|NCT01115244|Secondary|Number of Papules, Plaques and Vesicles on Treated and Untreated Elbows or Knees of Patients Who Have One Extremity Treated With Dapsone Gel, 5%|Lesion types will be counted at recorded at each visit. The mean lesion counts for papules, plaques and vesicles, as well as mean reduction of disease burden from baseline at week six for each of these categories, will be determined.|6 weeks of treatment|||||||
2718074|NCT01115244|Primary|Number and Size of All Lesions on the Treated and Untreated Elbows or Knees of Patients With Dermatitis Herpetiformis Who Have One Extremity Treated With Dapsone Gel, 5%|The primary objective is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Digital photographs of each elbow or each knee (treatment and control) will be taken. The number and size of lesions will be recorded for the treatment and control elbow or knee. This process will be repeated at each follow up visit.|6 weeks of treatment|||||||
2718075|NCT01115231|Secondary|Percentage of Complement Pathway Proteins in the Serum|To assess systemic complement activation, venus blood is collected. Complement component analysis was performed as a fee for service at the National Jewish Health Advanced Diagnostic Laboratories, using commercially available kits. Samples were analyzed in two batches in which the ELISA displayed difference sensitivities. Therefore data was normalized within each batch to values obtained from control subjects. Data reported represents the average of the two batches.|within a month of obtaining blood sample|Multivariate analyses were conducted through the use of general linear mixed models. The models did include random subject effects to account for dependence among repeated measurements of subjects. This type of model is ideal when there are multiple measurements on subjects, such as when laboratory measurements are performed in triplicate.|||percentage of control||Standard Deviation|Mean
2718076|NCT01115231|Secondary|Number of Participants With Signal Nucleotide Polymorphisms for CFH Locus|To assess for risk of AMD. Cells remaining from the serum separation were used for genetic analysis. Genomic DNA was extracted using a commercially available DNA extraction kit according to the manufacturer's instructions (QIAmp® DNA Mini; Qiagen). The AMD-associated SNP was genotyped at CFH (rs3766404), locus using PCR-based assays (TaqMan assays, Applied Biosystems), according to the manufacturer's instructions. Only white Caucasians in the population were included.|Blood sample collection at contact|Participants of European descent|||Participants|||Count of Participants
2718077|NCT01115231|Secondary|Number of Participants That Are Smokers|Patients were asked during patient interview as to their history of smoking (current, never or ever was assessed).|Day 1 of study||||Participants|||Count of Participants
2718078|NCT01115231|Primary|Age in Study Participants|Assessment of Age based on clinical records.|baseline visit||||years||Standard Deviation|Mean
2718079|NCT01115166|Other Pre-specified|Fluid Extravasation|Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.|Two distribution half-times. Approximately 16 minutes.|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.|||mL/kg/min||Standard Deviation|Median
2718080|NCT01115166|Secondary|Intracellular Edema|"Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.~A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass."|30 minutes after CPB|Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency.|||Litre||Standard Deviation|Mean
2718081|NCT01115166|Primary|Blood Volume|"volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.~The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.~The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.~To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated."|30 minutes after start of CPB|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.|||Litre||Standard Deviation|Mean
2718082|NCT01115101|Secondary|Costs|Evaluation costs between groups|6 month|||||||
2718083|NCT01115101|Secondary|Mobilisation|Evaluation of time to post surgical mobilization|6 month|||||||
2718084|NCT01115101|Secondary|Side Effects|Evaluation of side effects|6 month|||||||
2718085|NCT01115101|Secondary|Subgroups|Secondary Outcome Measures were to identify subgroups in benefit of either therapy.|6 month|||||||
2718092|NCT01114997|Primary|Number of Participants With Post Operative Pain One Month After Surgery|"Highest Post Operative pain one month after surgery, using a verbal rating score from 0 (no pain) to 10 (highest level of pain).~Patient received a post-operative follow-up call one month after surgery."|1 month|Experience of pain at home|||participants|||Number
2718093|NCT01114997|Primary|Post Operative Pain|Outcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.|1 day||||Score on a scale||Standard Deviation|Mean
2718094|NCT01114971|Secondary|Low Appetite|Participant who experienced low appetite (follow up questionnaire)|1 month||||participants|||Number
2718095|NCT01114971|Secondary|Patient Satisfaction Using a Verbal Rating Scale From 0 to 10|Patient satisfaction using a verbal rating scale from 0 to 10 Where a VRS is a subjective measure in which individuals verbally rated their level of satisfaction on an eleven-point numerical scale. The scale is composed of 0 (excellent satisfaction) to 10|1 month||||score on a scale (0-10)||Standard Deviation|Mean
2718096|NCT01114971|Secondary|Return to Feeling Normal|Days to report to return to feeling normal, using follow up questionnaires|1 month||||Days||Standard Deviation|Mean
2718097|NCT01114971|Secondary|Postoperative Nausea and Vomiting|Nausea and vomiting will be measured at PACU|1 day||||participants|||Number
2718098|NCT01114971|Secondary|Number of Participant With Opioid Consumption|n=Post discharge use of opioid consumption NUMBER OF PARTICIPANTS WHO TOOK PAIN KILLER PILLS|1 month||||participants|||Number
2718099|NCT01114971|Primary|Postoperative Pain|Postoperative pain will be measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 VRS is a subjective measure in which individuals verbally rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)|one day||||Score on scale 0-10||Standard Deviation|Mean
2718100|NCT01114945|Primary|Glottis View Using the Cormack Lehane Score|"Cormack Lehane score classification:~Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible"|Up to 1 minute|Cormack Lehane score (grade:1/2/3/4 [n])|||participants|||Number
2718101|NCT01114945|Primary|Percentage of Glottic Opening (POGO) [%]|"POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%.~View of the glottic opening (0-100%) during the intubation process."|up to 1 minute||||percentage of glottis opening||Standard Deviation|Mean
2718102|NCT01114945|Primary|Time to Obtain Glottis Visualization (Seconds)|"It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view.~Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery"|up to 1 minute||||Seconds||Standard Deviation|Mean
2718103|NCT01114945|Primary|Intubation Time Using a Stop Watch|Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.|up to 3 minutes|"Times following initial insertion of laryngoscope blade:~to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)"|||Seconds||Standard Deviation|Mean
2718104|NCT01114893|Secondary|IOP Change From Baseline at 8 PM on Day 5|Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment|5 Days||||mm Hg||95% Confidence Interval|Mean
2718105|NCT01114893|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5|Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment|5 days||||mm Hg||95% Confidence Interval|Mean
2718106|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 24|ITT analysis set, observed cases|||units on a scale||Standard Deviation|Mean
2718107|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 12|ITT analysis set, observed cases|||units on a scale||Standard Deviation|Mean
2718108|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 24|ITT analysis set, LOCF|||milligrams/liter||Standard Deviation|Mean
2718109|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 12|ITT analysis set, LOCF|||milligrams/liter||Standard Deviation|Mean
2718110|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718111|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718112|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 24|ITT analysis set, LOCF|||centimeters||Standard Deviation|Mean
2718113|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 12|ITT analysis set, LOCF|||centimeters||Standard Deviation|Mean
2718114|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 24|ITT analysis set, LOCF|||units on a scale||Standard Deviation|Mean
2718115|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 12|ITT analysis set, LOCF|||units on a scale||Standard Deviation|Mean
2718116|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 24|ITT analysis set, LOCF|||millimeters||Standard Deviation|Mean
2718117|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 12|ITT analysis set, LOCF|||millimeters||Standard Deviation|Mean
2718118|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 24|ITT analysis set, missing data imputed by last observation carried forward (LOCF)|||millimeters||Standard Deviation|Mean
2718119|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 12|ITT analysis set, missing data imputed by last observation carried forward (LOCF)|||millimeters||Standard Deviation|Mean
2718120|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718121|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718122|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718123|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718124|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718125|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718126|NCT01114880|Secondary|Number of Participants Meeting the ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
2718127|NCT01114880|Primary|Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.|||participants|||Number
2718128|NCT01114828|Secondary|Ascites Volume as Measured by CT|Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.|Baseline, Day 7 or at the discontinued of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.|||mL||Standard Deviation|Mean
2718129|NCT01114828|Primary|Body Weight|Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.|Bseline, Day 7 or at the discontined of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.|||kg||Standard Deviation|Mean
2718130|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26||||T score||95% Confidence Interval|Least Squares Mean
2718131|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26||||T score||95% Confidence Interval|Least Squares Mean
2718132|NCT01114737|Primary|Number of Participants With a Score of 1 or 2 in Global Function Evaluation (CGI-I) From Baseline to Week 13.|"Effects of 6R-BH4 on global function in PKU subjects in subjects that had a blood Phe level reduction after treatment with 6R-BH4 at screening.~The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."|13 weeks|Missing data for 1 subject in the Responders in 6R-BH4 20 mg/kg/day Arm|||Number of participants with scale 1 or 2|||Number
2718133|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject's mental illness at the time of assessment, relative to clinician's past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Mean
2718134|NCT01114737|Secondary|Change in Hamilton Rating Scale For Depression (HAM-D) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Least Squares Mean
2718135|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Least Squares Mean
2718136|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Least Squares Mean
2718137|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is <18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
2718138|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is >=18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
2718139|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject's mental illness at the time of assessment, relative to clinician's past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Week 13 to Week 26|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
2718140|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Week 13 to Week 26|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
2718141|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Week 13 to Week 26|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
2718142|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Week 13 to Week 26|Phe Responders with ADHD Symptoms|||units on a scale||95% Confidence Interval|Least Squares Mean
2718143|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are <18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
2718144|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are >=18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
2718145|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 13|"Effects of 6R-BH4 on global function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject's mental illness at the time of assessment, relative to clinician's past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 13|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
2718167|NCT01114646|Primary|Post-Operative Myocardial Infarction|Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.|1 week post-operation|||||||
2718146|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of depression in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 13||||units on a scale||95% Confidence Interval|Least Squares Mean
2718147|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of anxiety in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 13||||units on a scale||95% Confidence Interval|Least Squares Mean
2718148|NCT01114737|Primary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of ADHD in PKU subjects who had symptoms of ADHD at screening in the subjects that had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 13||||units on a scale||95% Confidence Interval|Least Squares Mean
2718149|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn or were lost to follow-up before the lower limit of the 12 mos follow-up window.One subject was lost to follow-up and one withdrew before 12 mos. One of these subjects experienced an AE before study exit and was included in the analysis,|||participants|||Number
2718150|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 30 days|Based on number of ITT subjects with available data.|||participants|||Number
2718151|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
2718152|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
2718153|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
2718154|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
2718155|NCT01114724|Secondary|Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment||At 12 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
2718156|NCT01114724|Secondary|Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment||At 6 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
2718157|NCT01114724|Secondary|Subjects With Secondary Endovascular Procedures||Through12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)|||participants|||Number
2718158|NCT01114724|Secondary|Aortic Rupture||Within 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)|||participants|||Number
2718159|NCT01114724|Secondary|Aortic Rupture||Within 30 days|Based on number of ITT subjects with available data.|||participants|||Number
2718160|NCT01114724|Secondary|Subjects With Coverage of Primary Tear||At implant|Based on number of ITT subjects with available data|||participants|||Number
2718161|NCT01114724|Secondary|Subjects With Successful Delivery and Deployment of the Device.||At implant.|Based on number of ITT subjects with available data|||participants|||Number
2718162|NCT01114724|Secondary|All-cause Mortality||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)|||participants|||Number
2718163|NCT01114724|Primary|All Cause Mortality.||Up to 30 days after the stent graft implant.|Based on number of ITT subjects with available data|||participants|||Number
2718164|NCT01114672|Primary|Severity of Pruritis|"Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis.~Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis."|Baseline and end of study (up to 12 weeks)|Number randomized in each arm 25|||units on a scale||Standard Deviation|Mean
2718165|NCT01114646|Secondary|Energy/Fatigue Scale|An inquire about fatigue, level of energy and self-efficiency.|1 year|||||||
2718166|NCT01114646|Secondary|Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale|A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.|1 year|||||||
2718168|NCT01114646|Primary|Post-Operative Unstable Angina|Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.|1 week post-operation|||||||
2718169|NCT01114646|Primary|Mortality|Assessment of post-operative mortality at one-year.|1 year||||pecent|||Number
2718170|NCT01114620|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 182)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718171|NCT01114620|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Subjects|||Number
2718172|NCT01114620|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718173|NCT01114620|Secondary|Number of Subjects With Abnormal Urine Sampling Parameters|Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.|At Day 0 and Day 7|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718174|NCT01114620|Secondary|Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels|Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells. Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 and Day 7|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718175|NCT01114620|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Day 0 up to Day 182)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718176|NCT01114620|Secondary|Number of Subjects With MAEs|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718177|NCT01114620|Secondary|Number of Subjects With Medically Attended AEs (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718178|NCT01114620|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2718179|NCT01114620|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718180|NCT01114620|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2718181|NCT01114620|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2718182|NCT01114620|Secondary|Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease|VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
2718183|NCT01114620|Secondary|Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2718184|NCT01114620|Secondary|Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2718185|NCT01114620|Secondary|Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2718186|NCT01114620|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
2718187|NCT01114620|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2718188|NCT01114620|Secondary|GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Fold change||95% Confidence Interval|Geometric Mean
2718189|NCT01114620|Secondary|Number of Seroprotected Subjects for HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
2718190|NCT01114620|Secondary|Number of Seroconverted Subjects for HI Antibodies|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
2718191|NCT01114620|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2718192|NCT01114620|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2718193|NCT01114620|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
2718194|NCT01114620|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2718195|NCT01114620|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Fold change||95% Confidence Interval|Geometric Mean
2718196|NCT01114620|Primary|Number of Seroprotected Subjects for HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2718197|NCT01114620|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies|Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
2718198|NCT01114581|Secondary|Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.||Within 10 days of developing symptoms associated with a respiratory tract infection|The data for this secondary outcome cannot be reported as operational issues with the collection and transport of the samples occurred.||||||
2718199|NCT01114581|Secondary|Guaifenesin AUC(0-3)||3 hours following dose administration||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2718200|NCT01114581|Primary|Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs|Percentage of inhaled radioactive tracer (Ave180Clear)|3 hours following inhalation of radioactive tracer particles|Intent to treat|||Percentage of inhaled radioactive tracer||Standard Deviation|Mean
2718201|NCT01114555|Secondary|To Measure Time to Progression in Patients With Resistant NB Treated With the Combination of Irinotecan, Temozolomide and Bevacizumab.||3 years|Data were not collected||||||
2718202|NCT01114555|Secondary|To Evaluate Changes in Angiogenic Markers After Treatment With the Combination of Irinotecan, Temozolomide and Bevacizumab.||days 1,4, 15 and once between days 22-35 during cycle 1 and cycle 2|Data were not collected||||||
2718203|NCT01114555|Secondary|Number of Participants With Treatment Related Toxicity|To determine the toxicity of the combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.|Patients will be evaluated at least once weekly for toxicity. Observation for toxicities for up to 42 days||||Participants|||Count of Participants
2718204|NCT01114555|Primary|Overall Responses|To evaluate tumor responses to combination of irinotecan, temozolomide and bevacizumab in patients with resistant NB.|15-35 days after cycle 2||||Participants|||Count of Participants
2718205|NCT01114529|Secondary|Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis)|(treated BPAR ≥ IB, graft loss or death)A comparison of the incidence rates for the individual components of the composite efficacy endpoint between treatment arms|at 24 months post-transplantation|Full Analysis Set|||Number of incidence|||Number
2718206|NCT01114529|Secondary|Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24|Evolution of left ventricular mass and hypertrophy were evaluated by left ventricular mass index (LVMi) assessed by echocardiography. LVMi is derived using a standard formula from dimensional measurements on the echocardiogram. Analysis of covariance was applied with treatment, center (as a random effect), and donor type as factors and LVMi at Randomization as covariate.|Randomization, Month 12 and Month 24|Full Analysis Set consists of only patients with triple LVMi values available at randomization, Month 12 and month 24 are included|||g/m^2.7||Standard Deviation|Mean
2718337|NCT01113541|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index = weight in kilograms (kg) / height in meters (m)^2 .|Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study.|||kg/m^2||Standard Deviation|Mean
2718207|NCT01114529|Secondary|Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, or (3) death . *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted.|at 12 months and month 24 post-transplantation|Full Analysis Set|||Number of incidence|||Number
2718208|NCT01114529|Primary|Estimated Glomerular Filtration Rate (eGFR)|Assessment of renal function by comparing change from randomization to Month 12 in eGFR ‎‎(MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R =|Month 12|Full Analysis set - observed eGFR values at month 12 (counted the patients with available values)|||mL/min/1.73m^2||Standard Deviation|Mean
2718209|NCT01114516|Secondary|Birthweight|Median birthweight|24 weeks||||grams||Inter-Quartile Range|Median
2718210|NCT01114516|Secondary|Neonatal Morbidity and Mortality|Days spent in the neonatal intensive care unit|1 year||||days||Inter-Quartile Range|Median
2718211|NCT01114516|Secondary|Gestational Age at Delivery|Median gestational age at delivery|24 weeks||||weeks||Inter-Quartile Range|Median
2718212|NCT01114516|Secondary|Gestational Latency of More Than 28 Days|The frequency of achieving a gestational latency of more than 28 days|28 days postpartum||||percentage of participants|||Number
2718213|NCT01114516|Primary|Gestational Latency Achieved Between Cerclage Placement and Time of Delivery|Median gestational latency achieved Between Cerclage Placement and Time of Delivery|24 weeks||||days||Inter-Quartile Range|Median
2718214|NCT01114503|Secondary|Assessment of Exploratory Biomarkers of Ribonucleic Acid (RNA) Transcription Analysis of Peripheral Blood|The exploratory biomarkers of RNA transcription analysis of peripheral blood was planned to be assessed on Day 1(pre dose), Week 4 and Week 24. The assessment was to be done using microarray and RNA expression using quantitative reverse transcription polymerase chain reaction (RT-PCR). This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718215|NCT01114503|Secondary|Assessment of Exploratory Biomarkers|The exploratory biomarkers were planned to be assessed on Day 1 (pre dose), Week 4, Week 12 and Week 24. It included assessment of peripheral blood mononuclear cells (PBMC) markers, suppression assays for the measure of effector cell proliferation, quantification of effector memory T-cells subsets, autoreactivity assays using cytokine production of supernatants and CFSE dilution, cytokine production by in-vitro stimulated T-cells, circulating serum biomarkers and may include subsequently discovered biomarkers of the biological response associated with GO or medically related conditions and/or the action of otelixizumab. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718216|NCT01114503|Secondary|Assessment of Circulating Cytokines of Interleukin 6 (IL6), IL10, Interferon Gamma (IFNγ) and Tumor Necrosis Factor Alpha (TNFα) up to 2 Weeks|Assessment of circulating cytokines of IL6, IL10, IFNγ and TNFα was planned to be assessed on Day 1-8 (pre dose) and Week 12. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 2|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718217|NCT01114503|Secondary|Assessment of Anti-otelixizumab Antibodies|Anti-otelixizumab antibodies were planned to be assessed on Day 1 (pre dose), Day 8 (pre dose), Week 4-24 and Month 12. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Month 12|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718218|NCT01114503|Secondary|Change From Baseline Measurement of Orbital Volume as Measured by Computed Tomography (CT) Scan|The assessment of orbital volume measured by CT scan was planned to be assessed on Week 12 and Week 24. Baseline was referred to assessment at Screening. Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Screening), Week 12 and Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718219|NCT01114503|Secondary|Change From Baseline for Participant-reported Health Related Quality of Life (QoL) Questionnaires of Short Form 36 ( SF-36) and Graves Ophthalmopathy (GO) QoL|Assessment of health related QoL was planned to be evaluated using the validated, disease specific, GO-QoL questionnaire and the SF-36 health survey questionnaire at Day 1 (pre dose) and Week 2- 24. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflected better outcomes. Baseline was referred to assessment on Day 1 (pre dose). Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Day 1, pre dose) to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718230|NCT01114503|Primary|Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)|The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 - 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 - 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 - 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 - 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24.|Up to Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
2718220|NCT01114503|Secondary|Change From Baseline for Individual Scores at Week 12 Incorporated in the European Group on Graves' Orbitopathy (EUGOGO) Assessment Including, Eyelid Swelling, Clinical Activity Score (CAS) Score, Proptosis, Lid Width and Diplopia|The EUGOGO assessment of change was defined by improvement or deterioration of clinical scores. Improvement in EUGOGO was defined as improvement in two of the following measures in at least one eye, without deterioration in any of the same measures in both eyes: eyelid swelling according to color atlas evaluation, CAS by at least 2 points, proptosis by at least 2 millimeter (mm) by Hertel exophthalmometer, lid width by at least 2 mm, diplopia (disappearance or change in the degree) or improvement of >=8 degrees in motility unexplained by commensurate deterioration of motility of ipsilateral antagonists. Deterioration was defined by worsening by same quantity (as for improvement) of the same measures. Baseline was referred to assessment on Day 1 (pre dose). Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Day 1, pre dose) and Week 12|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718221|NCT01114503|Primary|Assessment of CD3/T-cell Receptor (TCR) Complex Saturation and Modulation|The assessment of CD3/TCR complex saturation and modulation was planned to be assessed on Day (1-8) pre dose, Week 2, Week 4, Week 8, Week 12 and Week 24. The extent of modulation was to be determined by the extent of TCR alpha beta (αβ) expression which was proportional to the combined levels of free CD3 sites and bound otelixizumab to CD4+ and CD8+ T cells. Bound levels of otelixizumab was planned to be determined by using flow cytometry method using an anti Immunoglobulin (Ig) antibody. The molecules of equivalent soluble fluorochrome (MESF) of the anti-Ig antibody was to be used to quantify the levels of bound otelixizumab present on T cells. Free otelixizumab binding sites (i.e., sites not occupied by otelixizumab administered to the participants) was to be detected by staining with fluorescein isothiocyanate (FITC) labelled otelixizumab. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718222|NCT01114503|Primary|Percentage of Circulating Peripheral T-cells, CD4+ and CD8+ Subset Counts|The lymphocyte subsets of T-cells, CD4+ and CD8+ cells were planned to be assessed at Day 1 (pre dose), Day 8 (pre dose), Week 2, Week 4, Week 8, Week 12 and Week 24. The percentages of relevant lymphocyte subsets was to be determined by flow cytometry. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718223|NCT01114503|Primary|Individual Absolute Circulating Peripheral T Lymphocytes (T-cells), CD4+ and CD8+ Subset Counts|The lymphocyte subsets of T-cells, CD4+ and CD8+ cells were planned to be assessed at Day 1 (pre dose), Day 8 (pre dose), Week 2, Week 4, Week 8, Week 12 and Week 24. The absolute counts of the relevant lymphocyte subsets was to be determined by multiplying the percentages of the cell subsets with total lymphocyte counts. The percentages of relevant lymphocyte subsets was to be determined by flow cytometry. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
2718224|NCT01114503|Primary|Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC|The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12.|Week 2 to Week 12|All Subjects Population|||Participants|||Number
2718225|NCT01114503|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC|ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec.|Screening (Day -35 to Day -1)|All Subjects Population|||Participants|||Number
2718226|NCT01114503|Primary|Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC|Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline.|Up to Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
2718227|NCT01114503|Primary|Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC|The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24.|Up to Week 24|All Subjects Population|||Participants|||Number
2718228|NCT01114503|Primary|Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC|The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24.|Up to Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
2718229|NCT01114503|Primary|Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC|The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24.|Upto Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
2718231|NCT01114503|Primary|Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. The classification as potentially drug-related was done based on the investigator's judgment.|Up to Month 24 (Long term follow-up)|All Subjects Population included all participants who receive at least one dose of study medication.|||Participants|||Number
2718232|NCT01114438|Primary|Change From Baseline in SF 36v2 Quality of Life Assessment|Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.|Baseline, 12 months (explant), 6 months post explant (18 months post baseline)|The number of participants analyzed reflects all participants who received the implant and were assessed for QoL at the respective time points.|||units on a scale||Standard Deviation|Mean
2718233|NCT01114438|Primary|Changes in Diabetic Medications at Treatment Completion Compared to Baseline|number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)|12 months|Analysis was conducted on subjects with a device|||Participants|||Count of Participants
2718234|NCT01114438|Primary|Total Weight Change From Baseline to Week 52|Total weight change at 12 months (kg) compared to baseline|12 months|Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for weight loss analysis at the defined 12 month endpoint.|||kg||Standard Deviation|Mean
2718235|NCT01114438|Primary|HbA1c (%) Measured at Week 52||12 months|Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for analysis of HbA1c at the defined 12 month (week 52) endpoint.|||% glycated hemoglobin||Full Range|Median
2718236|NCT01114373|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||minutes||Standard Error|Mean
2718237|NCT01114373|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
2718238|NCT01114373|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
2718239|NCT01114373|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
2718240|NCT01114373|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
2718241|NCT01114373|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
2718242|NCT01114373|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
2718243|NCT01114373|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718244|NCT01114373|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718338|NCT01113541|Secondary|Change From Baseline in Weight||Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT; n = number of participants with evaluable data at observation.|||kilograms||Standard Deviation|Mean
2718245|NCT01114373|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718246|NCT01114373|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
2718247|NCT01114373|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718248|NCT01114373|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718249|NCT01114373|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718250|NCT01114360|Secondary|Percentage of Participants With Melatonin-related Side Effect.||After 4 weeks of treatment|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||percentage of total number of patients|||Number
2718251|NCT01114360|Secondary|Nocturnal Dipping of Blood Pressure|Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.|At the end of 4 weeks||||percentage ratio in night/day SBP||Standard Error|Mean
2718252|NCT01114360|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||minutes||Standard Error|Mean
2718253|NCT01114360|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
2718254|NCT01114360|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
2718255|NCT01114360|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|40 patients were enrolled in the study. 4 subjects did not complete the study. 36 patients completed the study and were their own controls.|||ng/ml/min||Standard Error|Mean
2718256|NCT01114360|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
2718257|NCT01114360|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
2718258|NCT01114360|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718259|NCT01114360|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
2718339|NCT01113541|Secondary|Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing.|||milligrams per deciliter||Full Range|Median
2718260|NCT01114360|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported.|At the end of 4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718261|NCT01114360|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718262|NCT01114360|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718263|NCT01114360|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
2718264|NCT01114360|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718265|NCT01114360|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
2718266|NCT01114334|Secondary|Patient Health Questionnaire-9 Instrument for Assessing Depressive Symptoms|"Depressive symptoms were measured with the Patient Health Questionnaire-9 (PHQ-9) instrument. The PHQ-9 is a nine item survey to assess depressive symptoms over the previous 2 weeks. The patient may answer not at all (scored as a 0) , several days (scored as a 1), more than half the days (scored as a 2), or nearly every day (scored as a 3) for each item. The range in total scores is from 0 (no depressive symptoms or best outcome) to 27 (severe depressive symptoms or worst outcome). For this randomized trial mean total scores are reported."|36 weeks||||units on a scale||95% Confidence Interval|Mean
2718267|NCT01114334|Secondary|Adherence to Treatment With Antidepressant Medication|"Antidepressant Adherence will be measured with Computerized Pharmacy Records. Adherence will be operationalized as non-persistence, or time to discontinuation. Non-persistence will be considered to have occurred if the days of medication supply from the previous prescription plus a 30-day grace period exceed the number of days between the previous prescription date and the current prescription fill date. Filling no prescriptions, 'initiation failure,' will be treated as non-persistence. Minimally adequate persistence was defined as at least three 30-day fills of an antidepressant medication at a usual dose as defined in the American Psychiatric Association guideline without a 30-day gap in refills. The count of participants receiving minimally adequate persistence with antidepressant medication is reported for each study group."|36 weeks||||Participants|||Count of Participants
2718268|NCT01114334|Primary|Depression Remission|The primary outcome is depression remission ascertained with the Patient Health Questionnaire-9. A score of less than 5 is considered to represent remission. The secondary clinical outcome is the continuous measure of depressive symptoms.|36 weeks|We present clinical outcome (remission rate) at 36 weeks for all patient participants entering the study. 58 of 80 subjects assigned to Guideline-Based Medical Management, and 67 of 88 subjects assigned to Motivational Interview with Guideline-Based Medical Management had available data at 36 weeks (end of trial).|||participants|||Number
2718269|NCT01114217|Secondary|Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline|"Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis.~The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered."|TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||days||Inter-Quartile Range|Mean
2718284|NCT01114139|Secondary|Mean Change In TSAT From Baseline To Week 5|"Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).~TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||percentage of saturation||Standard Deviation|Mean
2718270|NCT01114217|Secondary|Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol|"The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.~Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as:~FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).~TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course.~If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero."|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable FACIT-Fatigue Questionnaire data at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||units on a scale||Standard Deviation|Mean
2718271|NCT01114217|Secondary|Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol|Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for TSAT at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||percentage of saturation||Standard Deviation|Mean
2718272|NCT01114217|Secondary|Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol|Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|"ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.~Participants with no post-baseline hemoglobin values were classified as not achieving the increase.~Percentages are based on the number of participants in each course."|||percentage of participants|||Number
2718273|NCT01114217|Secondary|Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5|Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|"ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.~Participants with no post-baseline hemoglobin values were classified as not achieving the increase.~Percentages are based on the number of participants in each course."|||percentage of participants|||Number
2718274|NCT01114217|Secondary|Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course|"Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as:~Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered."|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||g/dL||Standard Deviation|Mean
2718275|NCT01114217|Primary|Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol|"Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1.~Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit."|TP Baseline (Day 1), TP Week 5|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||g/dL||Standard Deviation|Mean
2718276|NCT01114204|Secondary|Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline|The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.|From Baseline (Day 1) up to Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||days||Inter-Quartile Range|Mean
2718285|NCT01114139|Secondary|Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5|"Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
2718277|NCT01114204|Secondary|Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5|"The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.~Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as:~FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).~Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||units on a scale||Standard Deviation|Mean
2718278|NCT01114204|Secondary|Mean Change In TSAT From Baseline To Week 5|"Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||percentage of saturation||Standard Deviation|Mean
2718279|NCT01114204|Secondary|Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5|"Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
2718280|NCT01114204|Secondary|Mean Change In Hemoglobin From Baseline To Week 5|"Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline).~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||g/dL||Standard Deviation|Mean
2718281|NCT01114204|Primary|Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.~Statistical analysis was performed for data up to Week 5 only."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
2718282|NCT01114139|Secondary|Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline|The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.|From Baseline (Day 1) up to Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||Days||Inter-Quartile Range|Mean
2718283|NCT01114139|Secondary|Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5|"The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.~Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as:~FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).~Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||units on a scale||Standard Deviation|Mean
2718297|NCT01113801|Secondary|Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint|Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.|Baseline, 12 months|All randomized participants who received at least 1 dose of drug and had evaluable urine protein and creatinine ratio values.|||ln grams/grams [ln( g/g)]||Standard Error|Least Squares Mean
2718286|NCT01114139|Secondary|Mean Change In Hemoglobin From Baseline To Week 5|"Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as:~Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||g/dL||Standard Deviation|Mean
2718287|NCT01114139|Primary|Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.~Statistical analysis was performed for data up to Week 5 only."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
2718288|NCT01113931|Secondary|Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured|Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28|Day 28|N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.|||Percentage Participants Cured||95% Confidence Interval|Number
2718289|NCT01113931|Secondary|Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured|Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28|End of Study (Day 28)|M. genitalium Coinfected Population|||Percentage Participants Cured|||Number
2718290|NCT01113931|Secondary|Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured|Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28|End of Study (Day 28)|Clinically Evaluable Population|||Percentage Particpants Cured|||Number
2718291|NCT01113931|Primary|Microbiological Cure Rate|Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28|Day 28|mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.|||percentage of participants cured||95% Confidence Interval|Number
2718292|NCT01113879|Secondary|Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise|The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention.|six samples collected over a 16 week period|Complete BDNF datasets from 5 of the 7 participants who completed the study were available. BDNF data from the remaining two participants were not collected due to the PI and study team moving locations and no longer having access to the facilities.|||participants|||Number
2718293|NCT01113879|Primary|Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means|Tau-U effect sizes of <0.20 were considered small; 0.20 to <0.60 moderate; 0.60 to <0.80 large, and >=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.|administered before and after each of two, two week aphasia therapy blocks||||Tau U effect size weighted mean||80% Confidence Interval|Mean
2718294|NCT01113801|Secondary|Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months|Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) ) log transformed (ln) as covariates.|Baseline through 12 months|All randomized participants who received at least 1 dose of drug.|||mL/min/1.73 m²/month||Standard Error|Least Squares Mean
2718295|NCT01113801|Secondary|Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months|Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.|Baseline through 12 months|All randomized participants who received at least 1 dose of drug.|||ln milligrams per deciliter(mg/dL)/month||Standard Error|Least Squares Mean
2718296|NCT01113801|Secondary|Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval||Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)|All randomized participants who received at least 1 dose of drug and had evaluable PK data.|||microgram*hour per milliliter(µg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2718298|NCT01113801|Primary|Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint|Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.|Baseline, 12 months|All randomized participants who received at least 1 dose of drug and had evaluable baseline and post baseline serum creatinine values.|||ln milligrams per deciliter [ln(mg/dL)]||Standard Error|Least Squares Mean
2718299|NCT01113749|Post-Hoc|Percentage of Subjects With Weight Loss|Percentage of subjects with weight loss at 9 months|9 months|intention to treat|||percentage of participants|||Number
2718300|NCT01113749|Secondary|Percent With Treatment Decisions|Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.|3 months||||percentage of subjects|||Number
2718301|NCT01113749|Primary|Decisional Conflict Scale|Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.|3 months|intention to treat|||units on a scale||95% Confidence Interval|Mean
2718302|NCT01113723|Primary|Time to Confirm the Placement of the Tracheal Tube|It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform|up tp 3 minutes||||Seconds||Standard Deviation|Mean
2718303|NCT01113723|Primary|Intubation Time (Seconds)|Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube|3 minutes||||Seconds||Standard Deviation|Mean
2718304|NCT01113723|Secondary|Time to Obtain Glottis Visualization (Seconds)|Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.|1 minute|Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure.|||Seconds||Standard Deviation|Mean
2718305|NCT01113710|Secondary|Daytime Tiredness|"Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 561 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
2718306|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime in Activity|"Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
2718307|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime at Rest|"Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 562 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
2718308|NCT01113710|Secondary|Satisfaction With Sleep|"Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
2718309|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) During the Night|"Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
2718310|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) at Bedtime|"Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
2718311|NCT01113632|Secondary|Safety of the Treatment Regimen|Listing of all non-serious Adverse Events ocurring in 5% of patients or more|18 Months||||participants|||Number
2718312|NCT01113632|Secondary|Number of Partial Responses|The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|18 Months|All patients who were evaluable for a response assessment|||participants|||Number
2718313|NCT01113632|Secondary|Number of Complete Responses|The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions|18 Months|All patients who were evaluable for a response assessment|||participants|||Number
2718314|NCT01113632|Primary|Overall Response Rate (ORR)|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients who were evaluable for a response assessment|||participants|||Number
2718315|NCT01113632|Secondary|Progression-free Survival (PFS)|To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.|18 months||||months||95% Confidence Interval|Median
2718316|NCT01113580|Secondary|Frequency and Intensity of Any Unsolicited Adverse Events|"Unsolicited adverse event (UAE) grading:~Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.|||participants|||Number
2718317|NCT01113580|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The number of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.|||participants|||Number
2718318|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||Percentage of participants||95% Confidence Interval|Number
2718319|NCT01113580|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||Fold increase||95% Confidence Interval|Number
2718320|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||Percentage of participants||95% Confidence Interval|Number
2718321|NCT01113541|Secondary|Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline, Week 1 through Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||participants|||Number
2718334|NCT01113541|Secondary|Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.|Baseline, Week 4, Week 52 or Early Termination|PP and ITT; n = number of participants with analyzable data at observation.|||milliseconds||Standard Deviation|Mean
2718322|NCT01113541|Secondary|Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale|31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
2718323|NCT01113541|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on scale||95% Confidence Interval|Mean
2718324|NCT01113541|Secondary|Change From Baseline in EuroQoL Index (EQ-I)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on scale||95% Confidence Interval|Mean
2718325|NCT01113541|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)|0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on scale||Standard Deviation|Mean
2718326|NCT01113541|Secondary|Change From Baseline in Drug Attitude Inventory (DAI)|DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
2718327|NCT01113541|Secondary|Clinical Global Impression - Improvement (CGI-I) Subscale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
2718328|NCT01113541|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
2718329|NCT01113541|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS)|11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale|||Number
2718330|NCT01113541|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
2718331|NCT01113541|Secondary|Change From Baseline in Physical Activity Index|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||units on a scale|||Number
2718332|NCT01113541|Secondary|Change From Baseline in Leptin||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||nanograms per milliliter||Standard Deviation|Mean
2718333|NCT01113541|Secondary|Change From Baseline in Apolipoprotein B (ApoB) Levels||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||milligrams per deciliter||Standard Deviation|Mean
2718340|NCT01113541|Secondary|Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).|Baseline, Week 4, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
2718341|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides|MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimoles per liter||Standard Deviation|Mean
2718342|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)|MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimoles per liter||Standard Deviation|Mean
2718343|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose|MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimoles per liter||Standard Deviation|Mean
2718344|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure|MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimeters of mercury||Standard Deviation|Mean
2718345|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference|MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||centimeters||Standard Deviation|Mean
2718346|NCT01113541|Secondary|Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors|MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||percentage of participants|||Number
2718347|NCT01113541|Secondary|Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||percentage of participants|||Number
2718348|NCT01113541|Secondary|Metabolic Syndrome (MS) Prevalence|Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||percentage of participants|||Number
2718349|NCT01113541|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 52|PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||risk factors||Standard Deviation|Mean
2718350|NCT01113541|Primary|Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation|MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.|Week 52 or Early Termination|Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation.|||percentage of participants|||Number
2718365|NCT01112982|Secondary|Mean Serum Urate Levels for Previous 2 Years at Baseline.|"Determine if there is a correlation between the prevalence and severity of synovial pannus in the index joint with the patients' mean serum urate level from the previous 2 years at baseline."|previous 2 years upon enrollment into study||||mg/dL||Standard Deviation|Mean
2718351|NCT01113463|Secondary|Number of Participants by Response Criteria|Complete Response (CR): Complete disappearance all measurable & evaluable disease. No new lesions or evidence of non-evaluable disease. Partial Response (PR): >/= 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, nor new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 12 weeks duration. Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Unknown: Progression not been documented & one or more measurable or evaluable sites have not been assessed.|Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.|||participants|||Number
2718352|NCT01113463|Primary|Progression-Free Survival (PFS) at 6 Months|"PFS defined as number of participants alive without documented evidence of disease progression (progression free) at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|6 months (following nine 21-day cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.|||participants|||Number
2718353|NCT01113398|Secondary|Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities|The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.|2 years|Intent-to-treat|||percentage of participants|||Number
2718354|NCT01113398|Secondary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2718355|NCT01113398|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|2 years|Intent-to-treat|||Months||95% Confidence Interval|Median
2718356|NCT01113398|Primary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.|2 years|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2718357|NCT01113385|Secondary|Number of Participants Achieving Complete or Partial Remission at 16 Weeks|Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16. Complete remission is defined as (Urine Protein:Creatinine ratio [UPC] <0.2 g/g). Partial remission is defined as UPC 0.2-2 g/g.|16 weeks||||participants in remission at 16 weeks|||Number
2718358|NCT01113385|Primary|Focal Segmental Glomerulosclerosis Permeability Factor (FSPF)|FSPF is reported in relation to its induction of glomerular albumin permeability (Palb) of isolated glomeruli on a range from 0 to 1, with 0 indicative of normal glomeruli and 1 indicative of injury to the permeability barrier. Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16: Reduction in FSPF to <0.5 Palb or decrease in FSPF by > 0.3 Palb.|16 weeks||||Palb||Standard Deviation|Mean
2718359|NCT01113008|Secondary|Cardiovascular Mortality||12 month||||participants|||Number
2718360|NCT01113008|Secondary|Readmission Due to Acute Coronary Syndrome||12 month||||participants|||Number
2718361|NCT01113008|Primary|Maximum Increase of Troponin at 24 Hours||24 hours||||ng/ml||95% Confidence Interval|Mean
2718362|NCT01112982|Secondary|High-sensitivity C-Reactive Protein Concentrations|The concentration of serum high-sensitivity C-Reactive Protein at enrollment.|Upon enrollment into study at screening.|Serum High-Sensitivity C-Reactive Protein|||mg/dL||Standard Deviation|Mean
2718363|NCT01112982|Secondary|"Presence or Absence of Erosive Changes on Baseline Radiographs of the Index Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph."|"Baseline radiographs of the index joint will also be obtained on the same day as their MRI and assessed for the presence or absence of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, or soft tissue edema. This will be correlated with the presence and severity of synovial pannus in that same joint. The analysis will also be performed to see if there is a correlation with serum urate levels and the presence of erosions on their plain radiograph."|Upon enrollment into study||||Participants|||Count of Participants
2718364|NCT01112982|Secondary|The Severity of Synovial Pannus the Day of Serum High-sensitivity C-Reactive Protein and Magnetic Resonance Imaging|"Determine if the Number of Participants Prevalence and Severity of Synovial Pannus in the Index Joint with the patient's serum high-sensitivity C-Reactive Protein on the same day as the Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be assessed for the severity of synovial pannus, which is graded on a scale of 1 to 6 (with 6 being the most severe)."|Upon enrollment into study at screening.|"Severity of Synovial Pannus in the Index Joint"|||units on a scale||Standard Deviation|Mean
2718366|NCT01112982|Secondary|Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.|Number of Participants with Other Characteristic Findings of Gout on these MRI's. These include erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema. These secondary endpoints will also be summed with patients' serum urate levels.|Upon enrollment into study||||Participants|||Count of Participants
2718367|NCT01112982|Secondary|Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric).|"A sub-study in a subgroup of patients will analyze the Number and Percentage of Substudy Participants for whom the Severity of Synovial Pannus was Significantly Reduced After 9 Months of Treatment with Febuxostat (Uloric) in the index joint by comparing the baseline MRI with a repeat MRI of the same joint."|Upon enrollment into study, and at month 9.||||Participants|||Count of Participants
2718368|NCT01112982|Primary|Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline.|"The primary aim of this study will be to determine the percentage of patients with known gout who have evidence of chronic ongoing synovial-based inflammatory disease, i.e. synovial pannus, in their index joint, and determine if there is a correlation of the prevalence and severity of synovial pannus in the index joint with the patients' serum urate levels on the day of their MRI."|MRI and baseline uric acid level will be performed upon enrollment in the study.||||Participants|||Count of Participants
2718369|NCT01112917|Secondary|Major Device-Related Adverse Events in Converted Subjects||6-months|There was one subject (007-006) excluded as no 6-month images were available although a 6-month assessment was conducted.|||participants|||Number
2718370|NCT01112917|Primary|Technical Success|Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs. Further, in the analysis of the data, the sponsor did not count any filters as a 'technically' successful conversion when the operator was unable to snare the filter hook during an attempted conversion.|6-months||||participants|||Number
2718371|NCT01112865|Secondary|Ease of Use of Each Injection Pen|"Participants were asked the following question from Section I of the IPAQ PRO tool, Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall? Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1)."|Month 2 and Month 4|FAS; Number of participants analyzed (N) = participants with evaluable data|||scores on a scale||Standard Deviation|Mean
2718372|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen|"Investigators were asked the following study treatment continuation question, Which device did the participant choose for continued treatment? Choices included the Genotropin® Pen or the new injection pen."|Month 4|FAS subset of participants located in areas where the new device was available.|||percentage of dyads, adult participants||95% Confidence Interval|Number
2718373|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS|||percentage of dyads, adult participants||95% Confidence Interval|Number
2718374|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|FAS; Number of participants analyzed (N)= participants with evaluable data|||percentage of dyads, adult participants||95% Confidence Interval|Number
2718375|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS|||percentage of dyads, adult participants||95% Confidence Interval|Number
2718376|NCT01112865|Primary|Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|Full Analysis Set (FAS): randomized participants who used a study pen at least once to administer somatropin; Number of participants analyzed (N)= participants with evaluable data. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).|||percentage of dyads, adult participants||95% Confidence Interval|Number
2718377|NCT01112735|Secondary|Summary of Numbness Assessment by Visit|Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 [no numbness] to 10 [complete numbness]) that the patient experienced at the time of the visit.|Day 3, 7, 14, 28, 60, 90|FAS|||Score on a Scale||Standard Deviation|Mean
2718378|NCT01112735|Secondary|Summary of Pain Assessment by Visit|Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 [no pain] to 10 [worst possible pain]) the patient experienced at the site of surgery at the time of the visit.|Day 3, 7, 14, 28, 60, 90|FAS|||Score on a Scale||Standard Deviation|Mean
2718405|NCT01112579|Primary|Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.||Baseline and 6 months||||mL/m2||Standard Deviation|Mean
2718406|NCT01112514|Primary|Number of Neoplastic Lesions Detected||upto 15 mins||||Lesions|||Number
2718379|NCT01112735|Secondary|Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus|Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.|Days 0 (Baseline), 3, 7, 14, 28, 60, 90|FAS|||Score on a Scale||Standard Deviation|Mean
2718380|NCT01112735|Secondary|Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus|"Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand & Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO:~ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO."|Days 0 (Baseline), 3, 7, 14, 28, 60, 90|FAS|||Units on a Scale||Standard Deviation|Mean
2718381|NCT01112735|Secondary|Total Volume of Fluid Aspirations for Seromas|Volume of fluid recovered was recorded.|Day 0 (Surgery Day) to Day 90|FAS|||mL||Standard Deviation|Mean
2718382|NCT01112735|Secondary|Number of Fluid Aspiration for Seromas|Number of interventions recorded.|Day 0 (Surgery Day) to Day 90|FAS|||Interventions||Standard Deviation|Mean
2718383|NCT01112735|Secondary|Time to Drain Removal|The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.|Day 0 (Surgery Day) up to Day 90|FAS|||Days||Standard Deviation|Mean
2718384|NCT01112735|Secondary|Occurrence of Hematoma|The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.|Day 0 (Surgery Day) to Day 90|FAS|||Events|||Number
2718385|NCT01112735|Secondary|Occurrence of Seroma|The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.|Day 0 (Surgery Day) to Day 90|FAS|||Events|||Number
2718386|NCT01112735|Primary|Total Drainage Volume Collected Until Drain Removal|Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30 cc.|Day 0 (Surgery Day) to Day 90|Full Analysis Set (FAS) consists of all subjects who were randomized (ie, the investigator opened the randomization envelope) and treated and who had an available assessment for the primary efficacy endpoint.|||mL||Standard Deviation|Mean
2718387|NCT01112696|Secondary|Device Related Moderate or Device Related Severe Adverse Events|"Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy.~Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment.~Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device."|days one through six of sensor wear||||Participants|||Count of Participants
2718388|NCT01112696|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|98 subjects of 100 enrolled subjects (a total of 5857 paired sensor and YSI readings) completed participation in the inpatient frequent blood sampling procedure.|||paired sensor and YSI glucose readings|paired YSI/sensor glucose values|95% Confidence Interval|Number
2718389|NCT01112683|Secondary|Changes of Safety and Tolerability Assessments at Baseline and End of Study|Clinical history and physical examinations, electrocardiograms (ECGs), comprehensive clinical laboratory tests, and incidence of adverse event recording. The comprehensive clinical laboratory tests will include assessments of liver and kidney function, electrolytes, acid/base balance, and blood glucose and proteins. In addition, pregnancy tests will be performed on all female participants of childbearing potential.|Safety and tolerability assessments will be performed at three time points: 1) 1-7 days before beginning of treatment; 2) after 8 weeks from the beginning of the treatment; and 3) 16-17 weeks from the beginning of the treatment||||participants|||Number
2718407|NCT01112358|Secondary|Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled||Randomization to Day 8|ITT population|||Participants|||Number
2718408|NCT01112358|Secondary|Plasma Levels of LH||At the time of r-hCG administration (any days between Day 2 to Day 8)|ITT population|||IU per liter (IU/L)||Standard Deviation|Mean
2718409|NCT01112358|Secondary|rFSH Cumulative Dose||Randomization to Day 8|ITT population|||IU||Standard Deviation|Mean
2718410|NCT01112358|Secondary|Duration of Ovarian Stimulation|Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.|Randomization to Day 8|ITT population|||days||Standard Deviation|Mean
2718411|NCT01112358|Secondary|Endometrial Thickness||At the time of r-hCG administration (any days between Day 2 to Day 8)|ITT population|||millimeters (mm)||Standard Deviation|Mean
2718390|NCT01112683|Secondary|Changes in Benchmark Neuropsychological Measures From Baseline to End of Study|"The neuropsychological benchmark measures assessed in this study are~Peabody Picture Vocabulary Test-III (PPVT-III; range: -27.00 to 23.00)~Test for the Reception of Grammar (TROG; range: -13.00 to 19.00)~Verbal Fluency (from the Developmental Neuropsychological Assessment (NEPSY); range: -13.00 to 10.00)~Recall of Digits (Differential Ability Scales; DAS; -50.00 to 59.00)~Spatial working memory (SWM; part of the Cambridge Neuropsychological Test Automated Battery, or CANTAB; range: -9.00 to 8.00)~Scales of Independent Behavior Revised (SIB-R; -12.00 to 26.00) All listed values represent differences in scores obtained at baseline subtracted from scores at 16-weeks of treatment. With the exception of the spatial working memory, for all measures, higher values represent better outcome. For the spatial working memory, lower values represent better outcome."|Benchmark neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|These measures were not predicted to change due to memantine treatment. Measures of non-verbal reasoning, receptive language and vocabulary, short-term phonological memory, verbal and non-verbal working memory and adaptive/behavioral functioning were included.|||scores on a scale||90% Confidence Interval|Mean
2718391|NCT01112683|Primary|Changes in Neuropsychological Measures From Baseline to End of Study|"The hippocampus-dependent measures assessed in the present study are~Pattern recognition memory* - Measures visual memory for non-namable designs; scale range in dataset 4-24; higher score indicates better performance~Paired associates task* - Measures ability to learn visual associations between a picture and its location, and retention of this information over time; scale range in dataset 0-17; higher score indicates better performance~California Verbal Learning Test (CVLT) — Children's Version** - Measures episodic verbal memory (sum of the items recalled over the 4 learning trials); scale range in dataset 0-35; higher score indicates better performance~Rivermead Behavioral Memory Test-Children's version** - Measures episodic memory for visual information presented in context; scale range in dataset 1-20; higher score indicates better performance * used in power analysis calculation of sample size ** secondary measures associated with the primary hypothesis"|These neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|One participant dropped out of the study due to parent complaints of increased anxiety, and another was excluded from analyses due to side effects (increased and persistent anxiety) reported at study completion.|||units on a scale||90% Confidence Interval|Mean
2718392|NCT01112670|Other Pre-specified|Atorvastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng/ml||Standard Deviation|Mean
2718393|NCT01112670|Other Pre-specified|Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng*h/ml||Standard Deviation|Mean
2718394|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Renal Clearance (CLr)|CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.|||ratio||95% Confidence Interval|Mean
2718395|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.|||ml/min||Standard Deviation|Mean
2718396|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.|||ml/min||Standard Deviation|Mean
2718397|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax)|Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ratio||95% Confidence Interval|Mean
2718398|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity|AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ratio||95% Confidence Interval|Mean
2718399|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng/ml||Standard Deviation|Mean
2718400|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng*h/ml||Standard Deviation|Mean
2718401|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng/ml||Standard Deviation|Mean
2718402|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng*hr/ml||Standard Deviation|Mean
2718403|NCT01112579|Secondary|Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months||||mL/kg/min||Standard Deviation|Mean
2718404|NCT01112579|Secondary|Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months||||pg/mL||Standard Deviation|Mean
2718412|NCT01112358|Secondary|Plasma Level of Estradiol||At the time of r-hCG administration (any days between Day 2 to Day 8)|ITT population|||Picograms per milliliters (pg/mL)||Standard Deviation|Mean
2718413|NCT01112358|Secondary|Implementation Rate|Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Clinical pregnancy/embryo transferred||95% Confidence Interval|Number
2718414|NCT01112358|Secondary|Number of Participants With Clinical Pregnancy|A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac).|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Participants|||Number
2718415|NCT01112358|Secondary|Number of Participants With Positive Pregnancy Test|The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Participants|||Number
2718416|NCT01112358|Secondary|Number of Embryos Transferred by In Vitro Fertilization (IVF)||Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Embroys||Standard Deviation|Mean
2718417|NCT01112358|Secondary|Number of Embryos by Quality|Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (>50%).|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Embroys||Standard Deviation|Mean
2718418|NCT01112358|Secondary|Fertilization Rate|The fertilization rate (2 pronuclei [PN] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes.|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||2PN fertilized oocyte/inseminated oocyte||Standard Deviation|Mean
2718419|NCT01112358|Secondary|Oocyte Nuclear Maturity Rate|Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved.|At the end of stimulation (Day 2 up to Day 8)|ITT population|||metaphase II oocytes/retrieved oocyte||Standard Deviation|Mean
2718420|NCT01112358|Primary|Oocytes Recovery Rate|Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter.|At the end of stimulation (Day 2 up to Day 8)|ITT population|||oocytes per >14 mm follicle||Standard Deviation|Mean
2718421|NCT01112358|Primary|Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter||At the end of stimulation (Day 2 up to Day 8)|ITT population|||Follicles||Standard Deviation|Mean
2718422|NCT01112358|Primary|Number of Oocytes Retrieved||At the end of stimulation (Day 2 up to Day 8)|ITT population|||Oocytes||Standard Deviation|Mean
2718423|NCT01112293|Other Pre-specified|Biologic Response Measurements of TGFβ Blockade|Number of participants who demonstrated upregulation of NK cell receptors 3 weeks after treatment. There are data that show anti-TGFβ antibodies can upregulate NK cell receptors in patients with chronic viral infections. TGFβ blockade was measured in samples of serum tests and from pleural fluid or biopsy if available.|3 weeks|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Participants|||Count of Participants
2718424|NCT01112293|Other Pre-specified|Assessment of Systemic TGFβ After Repeated Anti-TGFβ Antibody Installation|The number of participants with significant change in percentage of circulating CD4+ T regulatory cells, marked by expression of FOXP3 after treatment. TGFβ has been implicated in the formation of T regulatory cells, and the blockade of TGFβ in animal models can inhibit the formation of T regulatory cells.|18 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Participants|||Count of Participants
2718425|NCT01112293|Other Pre-specified|Number of Participants With Systemic Humoral Anti-tumor Immune Response After Repeated Anti-TGFβ Antibody Instillation|Comparing antibody bands in pre-treatment versus post-treatment serum|18 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Participants|||Count of Participants
2718426|NCT01112293|Other Pre-specified|Number of Participants With a Change of Serum Biomarkers After Therapy|Evaluation of changes after treatment therapy to a number of potential blood biomarkers of TGF-β effect (serum osteopontin, serum hyaluronan, serum MMP-1, serum MMP-7, serum IL-6, plasma CCL18, plasma VEGF, and plasma PAI-1). Animal models predict acute changes in TGF-β levels in blood associated with changes in serum biomarkers.|18 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Participants|||Count of Participants
2718427|NCT01112293|Other Pre-specified|Response Rate Using Modified RECIST Criteria for Mesothelioma|Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in RECIST. The response assessment is based on the presence, absence, or unequivocal progression of the lesions.|18 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Participants|||Count of Participants
2718428|NCT01112293|Other Pre-specified|Time to Progression and Overall Survival|Assessment of time to disease progression and overall survival|18 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Months||95% Confidence Interval|Median
2718429|NCT01112293|Secondary|Toxicity and Safety of Systemic Infusion of Anti-TGF Antibody|The toxicity and safety of systemic infusion of anti-TGF antibody at three-week dosing intervals. Number subjects with Grade 2 and Grade 3/4 treatment related toxicities.|18 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||participants|||Number
2718430|NCT01112293|Primary|3-month Progression Free Survival Rate|The fraction of subjects surviving 3 months without disease progression.|3 months|Outcome analysis presented in manuscript of results of trial based on 13 participants.|||Participants|||Count of Participants
2718448|NCT01112059|Secondary|Mean Change in Pulmonary Function Over Treatment Duration|Observe change in FEV1% predicted from beginning to end of study|Baseline to end of inpatient clinical exacerbation (average 14 days)||||Percentage of predicted FEV1||Standard Deviation|Mean
2718431|NCT01112267|Secondary|Percentage of Participants With Participants' Global Assessment on Investigational Product|"Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2718432|NCT01112267|Secondary|Percentage of Participants With Investigator's Global Assessment on Investigational Product|"Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2718433|NCT01112267|Secondary|Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29|The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.|Baseline and Day 29|FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Unit on a scale||Standard Deviation|Mean
2718434|NCT01112267|Secondary|Change From Baseline in Short Form (SF)-36 Score at Day 29|"The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in Reported (Rptd.) Health Transition domain higher score indicates worse quality of life."|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Unit on a scale||Standard Deviation|Mean
2718435|NCT01112267|Secondary|Percentage of Participants With Pain Relief|Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.|Day 8, Day 15 and Day 29|the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Percentage of participants||95% Confidence Interval|Number
2718436|NCT01112267|Primary|Change From Baseline in Pain Intensity at Day 29|Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Unit on a scale||Standard Deviation|Mean
2718437|NCT01112267|Primary|Percentage of Participants With Reduction in Pain Intensity|The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline up to Day 29|Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2718438|NCT01112241|Primary|Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC (L), before bronchodilators - FRC (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute negative change (liters)||Standard Deviation|Mean
2718439|NCT01112241|Primary|Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC, expressed in liters (L), before bronchodilators - FRC (L) after bronchodilators/FRC (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent negative change||Standard Deviation|Mean
2718449|NCT01112059|Secondary|Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment|Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum|8 days||||ng/mg total protein||Standard Deviation|Mean
2718450|NCT01112059|Primary|Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum|Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy|8 days past baseline||||ng/mg total protein||Standard Deviation|Mean
2718440|NCT01112241|Primary|Absolute Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV (L), before bronchodilators - RV (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute negative change (liters)||Standard Deviation|Mean
2718441|NCT01112241|Primary|Per Cent Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV, expressed in liters (L), before bronchodilators - RV (L) after bronchodilators/RV (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent negative change||Standard Deviation|Mean
2718442|NCT01112241|Primary|Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'part increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'part, expressed in liters.second-1 (L.s-1), after bronchodilators - V'part (L.s-1) before bronchodilators/V'part (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
2718443|NCT01112241|Primary|Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'max increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'max, expressed in liters.second-1 (L.s-1), after bronchodilators - V'max (L.s-1) before bronchodilators/V'max (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following HSCT for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
2718444|NCT01112241|Primary|Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥0.20 liters (L) compared with baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC (L) after bronchodilators - FVC (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute positive change (liters)||Standard Deviation|Mean
2718445|NCT01112241|Primary|Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC, expressed in liters (L), after bronchodilators - FVC (L) before bronchodilators/FVC (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
2718446|NCT01112241|Primary|Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥0.20 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1 (L) after bronchodilators - FEV1 (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute positive change (liters)||Standard Deviation|Mean
2718447|NCT01112241|Primary|Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1, expressed in liters (L), after bronchodilators - FEV1 (L) before bronchodilators/FEV1 (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
2718453|NCT01111851|Secondary|Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)||30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
2718454|NCT01111851|Primary|Brain NK1-receptor Occupancy at 48 Hours Post Dose||48 hours post dose|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
2718455|NCT01111851|Primary|Brain NK1-receptor Occupancy at 24 Hours Post Dose||24 hours post dose|"All participants with at least 1 successful post dose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
2718456|NCT01111838|Primary|To Determine Overall Objective Response.|Patients with measurable disease will be evaluated using RECIST criteria for determination of response.|every 8 weeks||||participants|||Number
2718457|NCT01111825|Secondary|Overall Survival (OS)|Defined as the time from enrollment to death due to any cause; censored at the date last known alive.|From enrollment to date of death from any cause, or end of long term follow-up, assessed up to three years.|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||months||95% Confidence Interval|Median
2718458|NCT01111825|Secondary|Progression-free Survival (PFS)|Defined as time from date of enrollment until the first disease recurrence or progression or death due to any cause; censored at the last assessable evaluation or at the initiation of new anti-cancer therapy. Disease assessment is based on investigator tumor assessments. If no post-baseline tumor assessment then censored at enrollment date.|From date of enrollment until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to two years.|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||months||95% Confidence Interval|Median
2718459|NCT01111825|Secondary|Duration of Response (DOR)|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, Progressive Disease (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and/or the appearance of one or more new lesions.|From first response to first PD or death, assessed up to two years.|"Patients who were enrolled and responded in the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.~Note, no subject in Phase II triple negative cohort had a response. Therefore, no participants were analyzed for DOR."|||Participants|||Count of Participants
2718460|NCT01111825|Secondary|Clinical Benefit Rate (CBR)|"Defined as the proportion of patients who achieved objective response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~Clinical Benefit (CB) = CR + PR + SD >= 24 weeks."|From enrollment date to first documented response, or last tumor assessment, assessed up to two years|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||Participants|||Count of Participants
2718461|NCT01111825|Primary|Objective Response Rate (ORR) (Phase II)|"ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met."|From enrollment date to first documented response, or last tumor assessment, assessed up to two years|Intent to Treat (ITT) population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||Participants|||Count of Participants
2718462|NCT01111604|Secondary|Number of Participants With Adverse Events|A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 165 weeks|Population includes all the randomized participants who received at least one dose study drug.|||Participants|||Count of Participants
2718463|NCT01111604|Secondary|Serum Anti-Icrucumab Antibody Assessment|A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.|31 Weeks|Zero participants analyzed. No data collected to report.||||||
2718464|NCT01111604|Secondary|Number of Participants With Serum Ramucirumab Antibody Assessment|A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.|31 Weeks|Participants in mFOLFOX-6 +Ramucirumab who received at least one dose of study drug and had at least 1 post treatment assessment.|||Participants|||Count of Participants
2718465|NCT01111604|Secondary|Minimum Concentration (Cmin) at Day 15|Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.|Day 15 (cycles 1 and 5)|Zero participants analyzed. OM entered incorrectly and no data collected to report.||||||
2718466|NCT01111604|Secondary|Minimum Concentration (Cmin) at Day 8|Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.|Day 8 (cycles 1 and 5)|Zero participants analyzed. OM entered incorrectly and no data collected to report.||||||
2718467|NCT01111604|Secondary|Minimum Concentration (Cmin) at Day 4|Cmin is the minimum peak concentration measured in blood plasma after drug infusion.|Day 4 (cycles 1 and 5)|Zero participants analyzed. OM entered incorrectly and no data collected to report.||||||
2718471|NCT01111604|Secondary|Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5|Trough (prior to infusion, Ctrough) concentrations measured in serum.|Cycle 5, Prior to Infusion|All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable Ramucirumab or Icrucumab PK data to calculate Ctrough.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2718472|NCT01111604|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5|Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.|Cycle 5, 1 Hour Post End of Infusion|All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable ramucirumab or icrucumab PK data to calculate Cmax.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2718473|NCT01111604|Secondary|Duration of Response (DoR)|DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to < 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)|Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)|mITT population includes all the randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline DoR data. 2 participants were censored in mFOLFOX-6 arm, 2 in mFOLFOX-6 + Ramucirumab arm and 1 in mFOLFOX-6 + Icrucumab.|||Weeks||95% Confidence Interval|Median
2718474|NCT01111604|Secondary|Overall Survival (OS)|Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.|Baseline Until Death from Any Cause (Up to 163 Weeks)|mITT population includes all the randomized participants who received at least one dose of study drug. In mFOLFOX-6, mFOLFOX-6 + Ramucirumab, and mFOLFOX-6 + Icrucumab there were 12, 11, and 12 censored participants, respectively.|||Weeks||95% Confidence Interval|Median
2718475|NCT01111604|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.|Baseline until Disease Progression (Up to 95 Weeks)|mITT population includes all the randomized participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2718476|NCT01111604|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.|Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)|Modified Intent-to-Treatment (mITT) population includes all the randomized participants who received at least one dose study drug. In mFOLFOX-6, mFOLFOX-6+Ramucirumab and mFOLFOX-6 + Icrucumab, there were 13, 9 and 11 censored participants, respectively.|||Weeks||95% Confidence Interval|Median
2718477|NCT01111526|Secondary|Occurrence of Possibly Related Adverse Events|Number of participants with adverse events possibly related to study treatment, per event category.|5 years, 3 months|All participants|||participants|||Number
2718478|NCT01111526|Secondary|Stable or Improved Chronic GVHD Severity Score|Stable or improved Chronic GVHD score: Improved Mild to None; Improved Severe to Moderate; Improved Moderate to None, Remained Stable at Mild.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at 1 year.|||participants|||Number
2718479|NCT01111526|Secondary|Chronic GVHD Severity at MTD|Chronic GVHD maximum severity grade at MTD, in participants without overlap syndrome at initiation of study therapy. Maximum c-GVHD severity: Mild, Moderate, Severe.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at time of analysis.|||participants|||Number
2718480|NCT01111526|Secondary|Chronic GVHD Onset|Chronic GVHD onset in participants without overlap syndrome at initiation of study therapy. Number of participants with overlap syndrome at MTD.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.|||participants|||Number
2718481|NCT01111526|Secondary|Occurrence of Discontinuation of All Immune Suppression|Number of participants discontinuing all immune suppression without subsequent flare by 1 year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks and were evaluable at 365 days.|||participants|||Number
2718482|NCT01111526|Secondary|Overall Survival (OS)|Overall Survival (OS) at one year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.|||participants|||Number
2718483|NCT01111526|Secondary|Incidence of GVHD Flares Requiring Increasing Immune Suppressive Therapy|Number of participants with GVHD flares requiring increasing immune suppressive therapy within 36 days of study initiation. Cumulative incidence of GVHD flares requiring increasing immune suppressive therapy will be analyzed using the competing risk method by Gray (1988). GVHD flares (progressive disease (PD)) may result in discontinuation from Panobinostat.|Up to 36 days per participant|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.|||participants|||Number
2718484|NCT01111526|Primary|Phase II: Overall Rate of Response (ORR)|Rate of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD). Assessment of GVHD will include the skin, liver and gut. Other possible etiologies of organ disease such as C difficile enterocolitis, viral infection, drug reaction, veno-occlusive disease of the liver, etc., will be excluded by appropriate tests. CR is defined as resolution of GVHD in all evaluable organs with no subsequent additional treatment given for acute GVHD. PR is defined as improvement in ≥ one evaluable organ without deterioration in at least one other. PD is defined as deterioration in at least on evaluable organ. SD is defined as the absence of any difference sufficient to meet minimal criteria for improvement or deterioration in any evaluable organs.|1 year, 2 months|All participants treated at maximum tolerated dose (MTD) of Oral Formulation LBH589, and evaluable at planned time of analysis.|||participants|||Number
2718485|NCT01111526|Primary|Phase I: Maximum Tolerated Dose (MTD) in Milligrams|MTD of LBH589 in addition to glucocorticoids as treatment for Graft Versus Host Disease (GVHD) manifestations. MTD in Milligrams (mg), taken by mouth (PO), 3 times per week, for 4 weeks. The oral formulation replaced the IV formulation (which became unavailable) after the first 4 participants were treated. Dose limiting toxicity (DLT) is defined by the occurrence of Common Toxicity Criteria (CTC) grade 3 or greater toxicity that is unexpected with transplantation, except for hematological toxicity, where DLT is defined as absolute neutrophil count (ANC) <750, and for those participants who were platelet transfusion independent is defined as platelets <10 K.|2 years, 8 months|All participants treated with Oral Formulation LBH589, during Phase I Dose Escalation.|||MTD of oral LBH589 in milligrams|||Number
2718486|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Apparent Diffusion Coefficient (ADC) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in ADC for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 2 participants with evaluable data.|||Percentage change||Standard Deviation|Mean
2718487|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Contrast Volume Transfer Coefficient (Ktrans) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in Ktrans for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.|||Percentage change||Standard Deviation|Mean
2718488|NCT01111461|Other Pre-specified|Percentage Change From Baseline for the Imaging Biomarker Parameter of the Area Under the Plasma Concentration Curve Blood Normalized (90) (AUCBN (90)) Median for Total Volume|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of 2 dynamic contrast-enhanced magnetic resonance imaging/diffusion-weighted magnetic resonance imaging (DCE-MRI/DWI MRI) scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included percentage change in initial area under the gadolinium contrast agent time-concentration curve (first 90 seconds, blood normalized) from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.|||Percentage change||Standard Deviation|Mean
2718489|NCT01111461|Other Pre-specified|Summary of Plasma Concentration of Lenvatinib|A total of 6 blood samples for pharmacokinetic (PK) analysis were collected from each participant who received lenvatinib once daily.|Predose and 2 hours postdose on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 2 Day 1|PK analysis set was used and included all participants with an evaluable plasma concentration.|||ng/mL||Standard Deviation|Mean
2718490|NCT01111461|Secondary|Number of Participants With Adverse Events (AEs) /Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology, clinical chemistry, and urine values, regular measurement of vital signs, electrocardiograms (ECGs), and echocardiograms.|From the administration of first dose up to 30 days after the last dose, or up to data cut-off (21 May 2012), or up to approximately 26 months.|Safety Analysis Set included all participants who received at least 1 dose of lenvatinib and had at least 1 postbaseline safety evaluation. This was the analysis set for all safety evaluations.|||Participants|||Number
2718491|NCT01111461|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) [CR + PR + dSD] based on RECIST 1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 23 weeks), as determined by the IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Percentage of participants||95% Confidence Interval|Number
2718492|NCT01111461|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with BOR of CR or PR or stable disease (SD) based on RECIST 1.1 and SD lasting greater than or equal to 7 weeks, as determined by IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Percentage of participants||95% Confidence Interval|Number
2718493|NCT01111461|Secondary|Overall Survival (OS)|OS was the length time in months from the date of first treatment until the date of death from any cause. If death was not observed, OS was censored at the last known alive date or data cut-off. Additional survival follow-up data was collected for all participants who had not withdrawn consent and were alive at the time of the initial survival follow-up as of 26 Nov 2012 data cut-off. Participants who were lost to follow-up at the time of the initial assessment may have been contacted again at the investigator's discretion. Updated survival (based on 26 Nov 2012 cut-off) was derived for these participants if the contact was made successfully.|From date of first administration of study treatment until the date of death, or up to approximately 32 months (as of 26 Nov 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Months||95% Confidence Interval|Median
2718494|NCT01111461|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death (whichever occurred first), as determined by independent radiologic review (IRR) and Investigator based on RECIST 1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Months||95% Confidence Interval|Median
2718495|NCT01111461|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was ≤10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR|From the date of first administration of study treatment until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to the end of Cycle 6 (as of 21 May 2012 data cut-off)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) was used and included all participants who received at least 1 dose lenvatinib.|||Percentage of participants||95% Confidence Interval|Number
2718496|NCT01111370|Primary|the Proportion of G4 CGM System in Agreement With the Reference Standard|The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels >80 mg/dL and (±) 20 mg/dL at YSI glucose levels <80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.|Assessment done on either Day 1, 4 or 7 of the sensor wear period|Randomly enrolled|||%20/20||95% Confidence Interval|Mean
2718497|NCT01111331|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|Drug administration until beginning of next sequence/end of trial, 35 days|Treated set (TS) included all subjects who had taken at least one dose of trial medication.|||participants|||Number
2718498|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base)|Area under the PT-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the PT-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s*hr||95% Confidence Interval|Geometric Mean
2718499|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base)|Peak prothrombin time adjusted for baseline value (before any trial drug administration) of peak prothrombin|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s||95% Confidence Interval|Geometric Mean
2718500|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz)|Area under the PT-time curve from time of dosing to time of last measurable data point|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s*hr||95% Confidence Interval|Geometric Mean
2718501|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base)|Area under the INR-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the INR-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||ratio*h||95% Confidence Interval|Geometric Mean
2718502|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time (PTmax)|Peak prothrombin time|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s||95% Confidence Interval|Geometric Mean
2718503|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base)|Peak international normalised ratio for warfarin adjusted for baseline value (before any trial drug administration) of peak international normalised ratio|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||Ratio||95% Confidence Interval|Geometric Mean
2718504|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz)|Area under the concentration time curve of the INR measurements over the time interval from 0 to the time of the last quantifiable data point.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||ratio*h||95% Confidence Interval|Geometric Mean
2718505|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio (INRmax)|Peak international normalised ratio for warfarin, measured as the maximum INR over time.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||Ratio||95% Confidence Interval|Geometric Mean
2718506|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
2718507|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2718508|NCT01111331|Secondary|Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2718509|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2718510|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2718511|NCT01111331|Secondary|Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
2718512|NCT01111331|Secondary|Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2718513|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
2718514|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2718515|NCT01111331|Secondary|Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2718516|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2718517|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2718518|NCT01111331|Secondary|Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
2718519|NCT01111331|Secondary|Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2718520|NCT01111331|Secondary|Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss)|"Apparent volume of distribution during the terminal phase at steady state following extravascular administration.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
2718521|NCT01111331|Secondary|Empagliflozin: Apparent Clearance at Steady State (CL/F,ss)|"Apparent clearance in plasma after extravascular administration at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2718522|NCT01111331|Secondary|Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss)|"Mean residence time of empagliflozin (empa) in the body at steady state after oral administration.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2718523|NCT01111331|Secondary|Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)|"Time from last dosing to maximum plasma concentration at steady state over a uniform dosing interval τ.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
2718524|NCT01111331|Secondary|Empagliflozin: Terminal Half-life at Steady State (t1/2,ss)|"Terminal half-life of empagliflozin (empa) in plasma at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2718525|NCT01111331|Secondary|Empagliflozin: Terminal Rate Constant at Steady State (λz,ss)|"Terminal rate constant of empagliflozin (empa) in plasma at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2718526|NCT01111331|Secondary|Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N)|Plasma concentration of empagliflozin (empa) measured 24 hours after administration of the fourth dose (Cpre,5) and after the sixth dose (Cpre,7).|24 hours after dose 4 or 6 respectively (day 5 and day 7)|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2718527|NCT01111331|Primary|Warfarin S-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2718528|NCT01111331|Primary|Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2718529|NCT01111331|Primary|Warfarin R-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2718530|NCT01111331|Primary|Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2718531|NCT01111331|Primary|Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss)|"Maximum measured plasma concentration of empagliflozin (empa) for the dosing interval τ at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2718542|NCT01111318|Secondary|Terminal Rate Constant (λz)|"Terminal rate constant in plasma.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||1/h||Standard Deviation|Mean
2718532|NCT01111331|Primary|Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss)|"Area under the plasma concentration-time curve for the dosing interval τ at steady state~In addition to the specified time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2718533|NCT01111318|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).|Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days|Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment.|||participants|||Number
2718534|NCT01111318|Secondary|Urinary Glucose Excretion (UGE)|"Urinary glucose excretion, this endpoint was measured using Ae0-96.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||mg||Standard Deviation|Mean
2718535|NCT01111318|Secondary|Renal Clearance After Extravascular Administration (CL R)|"Renal clearance of empagliflozin (empa) in plasma after extravascular administration.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||mL/min||Standard Deviation|Mean
2718536|NCT01111318|Secondary|Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))|"Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||percentage of empagliflozin||Standard Deviation|Mean
2718537|NCT01111318|Secondary|Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)|"Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol||Standard Deviation|Mean
2718538|NCT01111318|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||L||Standard Deviation|Mean
2718539|NCT01111318|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||mL/min||Standard Deviation|Mean
2718540|NCT01111318|Secondary|Mean Residence Time (MRTpo)|"Mean residence time of empagliflozin (empa) in the body.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||h||Standard Deviation|Mean
2718541|NCT01111318|Secondary|Terminal Half-Life (t1/2)|"Terminal half-life of empagliflozin (empa) in plasma.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||h||Standard Deviation|Mean
2719139|NCT01106534|Primary|Incidence of ARC Definite or Probable ST||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2718543|NCT01111318|Secondary|Time From Dosing to Maximum Concentration (Tmax)|Time from dosing to maximum concentration of empagliflozin (empa) in plasma.|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||h||Full Range|Median
2718544|NCT01111318|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol*h/L||Standard Deviation|Mean
2718545|NCT01111318|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol/L||Standard Deviation|Mean
2718546|NCT01111318|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol*h/L||Standard Deviation|Mean
2718547|NCT01111305|Secondary|Proportion of Subjects Who Clear Blood Microfilariae||3, 7, and 28 days after initiation of treatment with DEC||||Participants|||Count of Participants
2718548|NCT01111305|Secondary|Markers of Eosinophil Activation Including Levels of Eosinophil Surface Marker Expression and Serum Levels of Eosinophil Granule Proteins||two years||2017-12-31|12/2017||||
2718549|NCT01111305|Secondary|Frequency of AE's|Adverse events during the first week of DEC treatment|7 days following initiation of DEC treatment|Subjects who received DEC treatment|||adverse events|||Number
2718550|NCT01111305|Primary|Change in Peak Eosinophil Count Measure as a Percent of Baseline Count.|Peak eosinophil count during the first 7 days of treatment as a percent of the baseline count|during the first 7 days of DEC treatment|Subjects who received diethylcarbamazine treatment|||percent change||Full Range|Geometric Mean
2718551|NCT01111292|Primary|The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.|The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-catenin staining in areas of low grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.|Baseline to 90 days|pβ-cat-positive cell counts in pre- and post-study biopsies with dysplasia or adenoma. Counts are broken down as the number of crypts with 3, 4, or 5 pβ-cat positive cells. High frequency (HF) fields of view are those containing at least 2 crypts with three or more pβ-cat positive cells per crypt (at 20X). I|||Colonic Biopsies||Standard Deviation|Mean
2718552|NCT01111240|Secondary|Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication|Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs|Baseline, and Months 6 and 24|FAS|||percentage of participants|||Number
2718553|NCT01111240|Secondary|Percentage of Participants With In-Patient Hospitalization|Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||percentage of particpants|||Number
2718554|NCT01111240|Secondary|Mean Number of Days Missed From Work Due to Psoriatic Arthritis|Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||days||Standard Deviation|Mean
2718555|NCT01111240|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit||Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||percentage of participants|||Number
2718556|NCT01111240|Secondary|Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time|A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
2718557|NCT01111240|Secondary|Participants Assessment of Pain Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
2718558|NCT01111240|Secondary|Participants Assessment of Fatigue Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
2718559|NCT01111240|Secondary|Patients Global Assessment of Disease Activity Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
2718560|NCT01111240|Secondary|Mean C-Reactive Protein (CRP) Levels Over Time|The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||mg/L||Standard Deviation|Mean
2718561|NCT01111240|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Over Time|The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||mm/hour||Standard Deviation|Mean
2718562|NCT01111240|Secondary|Number of Participants by Severity of Nail Psoriasis Levels Over Time|Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||participants|||Number
2718563|NCT01111240|Secondary|Number of Participants by Severity of Dactylitis Over Time|"Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to sausage digit, involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression."|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||participants|||Number
2718564|NCT01111240|Secondary|Number of Participants by Severity of Enthesitis Over Time|Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||participants|||Number
2718565|NCT01111240|Primary|Number of Participants With Adverse Events (AEs)|Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.|Baseline up to 24 months|Safety Set - All enrolled participants|||participants|||Number
2718566|NCT01111240|Primary|Mean Target Lesion Score (TLS) Over Time|The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||score on a scale||Standard Deviation|Mean
2718567|NCT01111240|Primary|Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time|Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||percentage of body surface area||Standard Deviation|Mean
2720885|NCT01092663|Primary|Fasting Plasma Glucose|Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.|Baseline and 12 weeks||||millimoles (mmol)/Liter (L)||Standard Deviation|Mean
2718568|NCT01111240|Primary|Mean Swollen Joint Count (SJC) Over Time|Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||Swollen Joints||Standard Deviation|Mean
2718569|NCT01111240|Primary|Mean Tender Joint Count (TJC) Over Time|Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||Tender joints||Standard Deviation|Mean
2718570|NCT01111240|Primary|Mean Change From Baseline in Disease Activity Score (DAS)28|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||score on a scale||Standard Deviation|Mean
2718571|NCT01111162|Primary|Immunogenicity|Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.|21-28 days|Among the 90 participants without evidence of previous exposure to H1N1, only 61% [95% confidence interval (CI) 51–71] developed protective titers by week 3 of the study (seroconversion rate).|||percentage of seroconversion||95% Confidence Interval|Number
2718572|NCT01111162|Primary|Safety|"To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care).~Safety was assessed via~Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses.~Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination."|21-28 days||||percentage of participants|||Number
2718573|NCT01111149|Secondary|Abnormal Movements - AIMS|Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.|Week 12||||units on a scale||Standard Deviation|Mean
2718574|NCT01111149|Secondary|Urge to Smoke - MNWS|The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.|Week 12||||percentage of time||Standard Deviation|Mean
2718575|NCT01111149|Secondary|Abstinence Related Symptoms - WISDM|The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.|Week 12||||units on a scale||Standard Deviation|Mean
2718576|NCT01111149|Secondary|Response Style Indicator (Beta) for CPT|Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.|Week 12||||Beta||Standard Deviation|Mean
2718577|NCT01111149|Secondary|Detectibility (d') of Continuous Performance Test|The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.|Week 12||||unitless||Standard Deviation|Mean
2718578|NCT01111149|Secondary|Variability of Standard Error - CPT|"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures within respondent variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12."|Week 12||||milliseconds||Standard Deviation|Mean
2718579|NCT01111149|Secondary|Hit Reaction Time - CPT|The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.|Week 12||||milliseconds||Standard Deviation|Mean
2718580|NCT01111149|Secondary|General Psychopathology|Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.|Week 12||||units on a scale||Standard Deviation|Mean
2718581|NCT01111149|Secondary|Positive Symptoms of Schizophrenia (SAPS)|Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
2718582|NCT01111149|Secondary|Suicidality|The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.|Week 12||||units on a scale||Standard Deviation|Mean
2718583|NCT01111149|Secondary|Vital Signs - Pulse|Pulse will be measured. The values below were measured at week 12 of the study.|Week 12||||heart beats per minute||Standard Deviation|Mean
2718584|NCT01111149|Primary|Smoking Abstinence - Exhaled Carbon Monoxide|Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.|Week 12||||parts per million||Standard Deviation|Mean
2718585|NCT01111149|Primary|Smoking Abstinence - Number of Cigarettes Smoked|Number of cigarettes smoked at week 12 of the study by self-report.|Week 12||||number of cigarettes smoked||Standard Deviation|Mean
2718586|NCT01111149|Secondary|Vital Signs - Weight|Weight will be measured for each participant. Values listed below are for week 12.|Week 12||||lbs||Standard Deviation|Mean
2718587|NCT01111149|Secondary|Vital Signs|blood pressure will be measured.|Week 12||||mm Hg||Standard Deviation|Mean
2718588|NCT01111149|Secondary|Abnormal Movements - BAS and SAS|"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.~Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity."|Week 12||||units on a scale||Standard Deviation|Mean
2718589|NCT01111149|Secondary|Depression|Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.|Week 12||||units on a scale||Standard Deviation|Mean
2718590|NCT01111149|Secondary|Abstinence-related Symptoms - MNWS and FTND|"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.~The Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine."|Week 12||||units on a scale||Standard Deviation|Mean
2718591|NCT01111149|Secondary|Side Effects|Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.|Week 12||||participants|||Number
2718610|NCT01111019|Secondary|Number of Subjects With Adverse Event (AE) and Serious Adverse Event (SAE)|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug , SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose.|Baseline up to 9.5 years|Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period.|||Subjects|||Number
2718592|NCT01111149|Secondary|Impulsivity and Inattention|Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.|Week 12||||Percentage of responses||Standard Deviation|Mean
2718593|NCT01111149|Secondary|Negative Symptoms of Schizophrenia - SANS|Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
2718594|NCT01111149|Secondary|Reduction in Smoking|Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12|Week 12||||participants|||Number
2718595|NCT01111149|Primary|Smoking Abstinence - Serum/Urine Measurements|Measured by blood/urine tests for nicotine and its break-down product cotinine.|Week 12||||ng/mL||Standard Deviation|Mean
2718596|NCT01111123|Secondary|Signs of Psoriasis, Atrophy or Telangiectasis|Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT.|||participants|||Number
2718597|NCT01111123|Primary|Physical Global Assessment|Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT).|||participants|||Number
2718598|NCT01111110|Primary|Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber|fifteen minutes after 4 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|||Diff in % change from 4AM||Standard Deviation|Mean
2718599|NCT01111110|Primary|Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber|15 minutes after 2 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|||Diff in % change from 4AM||Standard Deviation|Mean
2718600|NCT01111110|Primary|Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber|fifteen minutes after 1 puff of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|||Diff in % change from 4AM||Standard Error|Mean
2718601|NCT01111058|Secondary|Determine if PTEN Status is a Predictive Biomarker|Differential effect of PTEN status on progression-free survival between the two arms|4 years|Data were not collected.||||||
2718602|NCT01111058|Secondary|Correlation of Akt/mTOR Status With Progression-free Survival|mTOR positive in tumor tissue|4 years|Data were not collected.||||||
2718603|NCT01111058|Secondary|Akt/mTOR Pathway Activation|mTOR positive in tumor tissue|Baseline|Data were not collected.||||||
2718604|NCT01111058|Secondary|Second Primary Tumor|Number of patients with second primary tumor|4 years|Data not systematically recorded.||||||
2718605|NCT01111058|Secondary|Site of Progression: Unknown|Number of patients with unknown site of progression|4 years||||Participants|||Count of Participants
2718606|NCT01111058|Secondary|Site of Progression: Distant|Number of patients with distant progression|4 years||||Participants|||Count of Participants
2718607|NCT01111058|Secondary|Site of Progression: Local-regional|Number of patients with local-regional progression|4 years||||Participants|||Count of Participants
2718608|NCT01111058|Secondary|Number of Participants With Toxicity|Adverse event rate, any type, any grade regardless of attribution|4 years||||Participants|||Count of Participants
2718609|NCT01111058|Primary|2 Year Progression Free Survival Rate|Time to disease progression or death from any cause--2 year rate|2 years||||percentage of patients||95% Confidence Interval|Number
2718631|NCT01110967|Primary|Physical Functioning Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.|Up to 12 months follow up visit||||units on a scale||Standard Deviation|Mean
2718611|NCT01111019|Secondary|Number of Subjects With Fibroblast Growth Factor Receptor (FGFR3) Mutation|Genetic analysis was performed to record FGFR3 gene mutation. Genomic DNA was extracted from lymphocytes of collected blood samples using standard procedures. A set of intronic primers was designed based on the genomic sequence of the human FGFR3 gene and used to amplify exons 2-19. Number of subjects with FGFR3 mutation were reported.|Baseline up to 3 years|Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period.|||Subjects|||Number
2718612|NCT01111019|Secondary|C-terminal Telopeptide (CTX) Values of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) From Year 1 up to 9.5 Years|CTX (Blood) as bone marker was analyzed with the Immunology system Elecsys. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male), 9.5 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||picomole per liter (pmol/L)||Standard Deviation|Mean
2718613|NCT01111019|Secondary|Osteocalcin Values of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) From Year 1 up to 9.5 Years|Osteocalcin as bone marker was analyzed with the Immunology system Elecsys. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male), 9.5 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2718614|NCT01111019|Secondary|Head Circumference Values of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) From Year 1 up to 9.5 Years|Body proportion was measured in terms of head circumference with a tape measure. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||Centimeter (cm)||Standard Deviation|Mean
2718615|NCT01111019|Secondary|Growth (Height) Velocity of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) From Year 1 up to 9.5 Years|Growth velocity was calculated in terms of height velocity. It corresponded to a difference in height between current and baseline values divided by the time interval between both evaluations. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Centimeter per year (cm/year)||Standard Deviation|Mean
2718616|NCT01111019|Secondary|Change From Baseline in Lean Body Mass (LBM) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9 Years|Body composition measured as LBM. It was measured by Dual X-ray absorptiometry. Data was reported by gender. Male subjects were analyzed till 9 years and female subjects were analyzed till 8 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 9 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||Gram (g)||Standard Deviation|Mean
2718617|NCT01111019|Secondary|Change From Baseline in Percent Body Fat Mass of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9 Years|Body composition measured as percentage of body fat mass. It was measured by Dual X-ray absorptiometry. Data was reported by gender. Male subjects were analyzed till 9 years and female subjects were analyzed till 8 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 9 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||Percentage (%) of body fat mass||Standard Deviation|Mean
2718618|NCT01111019|Secondary|Change From Baseline in Bone Mineral Density (BMD) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9 Years|Body composition measured as BMD. It was examined at the lumbar spine (L1-L4) and determined annually by dual-energy X-ray absorptiometry. Data was reported by gender. Male subjects were analyzed till 9 years and female subjects were analyzed till 8 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 9 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||Gram per square centimeter (g/cm^2)||Standard Deviation|Mean
2718619|NCT01111019|Secondary|Change From Baseline in Body Mass Index (BMI) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9.5 Years|Body proportion measured as BMI. It was calculated according to the formula BMI = Weight (kilogram)/Height square (meter square). Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Kilogram per meter square (kg/m^2)||Standard Deviation|Mean
2719668|NCT01102218|Primary|Change in Erythropoietin Dose|Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.|Baseline and 6 months|The number of patients for analysis was based on those patient who had completed 6 months of treatment. The analysis was per protocol.|||Units EPO||Standard Deviation|Mean
2718620|NCT01111019|Secondary|Change From Baseline in Weight of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9.5 Years|The body weight was measured on a certified and calibrated hospital scale. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Kilogram (kg)||Standard Deviation|Mean
2718621|NCT01111019|Secondary|Change From Baseline in Upper Segment (Superior) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9.5 Years|Body proportion was measured in terms of upper segment for standing and sitting position. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"ITT population. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category. Number Analyzed was “0” at certain time points because there was no data collected at the specified time points."|||Centimeter (cm)||Standard Deviation|Mean
2718622|NCT01111019|Secondary|Change From Baseline in Height of Recombinant Human Growth Hormone (r-hGH) Treated Subjects With Hypochondroplasia (HCH) up to 9.5 Years|Body proportion was measured in terms of height. Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years.|Baseline (Month 0), Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period. Here Number Analyzed signifies those subjects who were evaluable for the specified category."|||Centimeter (cm)||Standard Deviation|Mean
2718623|NCT01111019|Secondary|Height-Standard Deviation Score (H-SDS) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects|Height was calculated in standardized units expressed as the standard deviation score (SDS), where SDS = (x - m)/sigma, in which x represents the height variable measured by sex and age, and m and sigma are the statistical parameters (mean and standard deviation) for the Sempe reference population. The reference population was the historical cohort consisting of non-treated subjects with Hypochondroplasia (HCH). Data was reported by gender. Male subjects were analyzed till 9.5 years and female subjects were analyzed till 8.5 years. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a participant's value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated smaller height for the respective age/gender.|Year 1, 2, 3, 4, 5, 6, 7, 8 (both male and female); 8.5 (only for female), 9 (only for male) and 9.5 (only for male)|"Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period. Here Number analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Standard Deviation Score (SDS)||Full Range|Median
2718624|NCT01111019|Primary|Height-Standard Deviation Score (H-SDS) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects at Year 4|Height was calculated in standardized units expressed as the standard deviation score (SDS), where SDS = (x - m)/sigma, in which x represents the height variable measured by sex and age, and m and sigma are the statistical parameters (mean and standard deviation) for the Sempe reference population. The reference population was the historical cohort consisting of non-treated subjects with Hypochondroplasia (HCH). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a participant's value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated smaller height for the respective age/gender.|Year 4|Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2718625|NCT01111019|Primary|Change From Baseline in Height-Standard Deviation Score (H-SDS) of Recombinant Human Growth Hormone (r-hGH) Treated Subjects at Year 3|Height was calculated in standardized units expressed as the standard deviation score (SDS), where SDS = (x - m)/sigma, in which x represents the height variable measured by sex and age, and m and sigma are the statistical parameters (mean and standard deviation) for the Sempe reference population. The reference population was the historical cohort consisting of non-treated subjects with Hypochondroplasia (HCH). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a participant's value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated smaller height for the respective age/gender.|Baseline (Month 0), Year 3|Intention to Treat (ITT) population included all subjects who received at least one dose of treatment with at least an efficacy assessment available during the treatment period.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2718626|NCT01110967|Primary|Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)||Patients were followed up according to the local practice, up to 1 year||||events|||Number
2718627|NCT01110967|Secondary|Changes in Device Placement||Up to 12 months follow up visit||||participant|||Number
2718628|NCT01110967|Secondary|Device Subsidence Measured as Interbody Height Ratio (IBHR)|Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.|Up to 12 months follow up visit||||ratio||Standard Deviation|Mean
2718629|NCT01110967|Secondary|Intervertebral Disc Space (IVD) at Implanted Level|The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as [(A+B)/2]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.|Up to 12 months follow up visit||||mm||Standard Deviation|Mean
2718630|NCT01110967|Secondary|Range of Motion (ROM) at Implanted Level|The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).|Up to 12 months follow up visit||||degrees||Standard Deviation|Mean
2720886|NCT01092663|Secondary|Fasting Plasma C-peptide|To evaluate the effect of treatments on plamsa C-peptide concentrations.|Baseline and 12 weeks||||picomoles (pmol)/Liter (L)||Standard Deviation|Mean
2718632|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit||||units on a scale||Standard Deviation|Mean
2718633|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Back Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit||||units on a scale||Standard Deviation|Mean
2718634|NCT01110915|Secondary|System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to four months post implant||||participants|||Number
2718635|NCT01110915|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.|During MRI scans|All subjects successfully implanted with the Advisa MRI system who underwent MRI scans were included in the analysis. All MRI scans, whether done at the 9-12 week visit in the MRI group, or done at other times in either group were included in this analysis.|||participants|||Number
2718636|NCT01110915|Secondary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.|||participants|||Number
2718637|NCT01110915|Secondary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.|||participants|||Number
2718638|NCT01110915|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.|||participants|||Number
2718639|NCT01110915|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.|||participants|||Number
2718640|NCT01110915|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.|MRI scan to one-month post-MRI scan|Subjects who had an MRI scan and completed their 4-month visit (or a later follow-up), or had an MRI-related complication within one month post-MRI were included in the analysis.|||participants|||Number
2718641|NCT01110707|Secondary|Mean Number of Oocytes Retrieved|Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocyte from the ovary of the female subject, enabling fertilization outside the body.|36 hours post r-hCG administration|The ITT analysis included all the randomized subjects who received at least 1 dose of study medication.|||Oocytes||Standard Deviation|Mean
2718642|NCT01110707|Secondary|Number of Cycles Cancelled Due to Unsatisfactory Response|If the subject was not administered with r-hCG and withdrew prematurely from the trail, it is considered as cycle cancellation|r-hCG day (end of stimulation cycle [approximately 28 days])|The ITT analysis included all the randomized subjects who received at least one dose of study medication.|||cycles|||Number
2718643|NCT01110707|Secondary|Endometrial Thickness||r-hCG day (end of stimulation cycle [approximately 28 days])|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||mm||Standard Deviation|Mean
2718644|NCT01110707|Secondary|Mean Number of Follicles Greater Than or Equal to (>=) 14 Millimeter (mm)|Mean number of follicles as per the following categories were presented: >=14 mm and less than (<) 16 mm; >=16 mm and <18 mm and >=18 mm.|r-hCG day (end of stimulation cycle [approximately 28 days])|The ITT analysis included all the randomized subjects who received at least 1 dose of study medication.|||Follicles||Standard Deviation|Mean
2718645|NCT01110707|Secondary|Clinical Pregnancy Rate|Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.|35-42 days post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||Percentage of subjects|||Number
2718646|NCT01110707|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|35-42 days post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||Percent sacs per embryo|||Number
2718647|NCT01110707|Secondary|Quality of Embryos|Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. Mean number of embryos for each of the 5 grades were reported.|Day 2-3 post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||embryos||Standard Deviation|Mean
2718648|NCT01110707|Secondary|Number of Fertilized Oocytes (2 Pronuclei [2PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|36 hours post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||2PN oocytes||Standard Deviation|Mean
2718649|NCT01110707|Primary|Mean Number of Metaphase II (M-II) Oocytes Retrieved|Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|36 hours post r-hCG administration|The Intention-To-Treat (ITT) analysis set included all the randomized subjects who received at least 1 dose of study medication.|||M-II oocytes||Standard Deviation|Mean
2718650|NCT01110681|Secondary|Number of Incontinence-free Days|Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).|At 12 month- change from baseline|Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.|||days||Full Range|Mean
2718651|NCT01110681|Secondary|Fecal Incontinence Quality of Life (FIQL)|Fecal Incontinence Quality of Life is a disease specific questionnaire composed of a total of 29 questions questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment. The FIQL mean score ranges from 1 to 4 for the Lifestyle, Coping/Behavior and Embarrassment domains, and from 1 to 4.429 for Depression/Self-Perception domain. Mean score were calculated for each of the four domains. The more the subject is affected by fecal incontinence the lower value. Change from baseline.|At 12 month - change from baseline|Intention to treat. Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.|||score on a scale||Full Range|Mean
2718652|NCT01110681|Secondary|Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score|"Cleveland Clinic Florida Incontinence Score (CCFIS) is a composite score of incontinence severity that measures the frequencies of gas leakage, leakage of solid or loose stool, use of protective pads and lifestyle alterations. The score ranges from 0 (representing complete continence)to 20 (representing complete incontinence).~Change from baseline."|12 month - change from baseline|Intention to treat. Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.|||units on a scale||Full Range|Mean
2718653|NCT01110681|Secondary|Number of Fecal Incontinence Episodes.|Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).|at 12 month - change from baseline|Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.|||episodes||Full Range|Mean
2718654|NCT01110681|Primary|Responder Rate in Number of Fecal Incontinence Episodes|"Responder rate in number of fecal incontinence episodes change from baseline at 12 month.~Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline."|12 months after last treatment compared to baseline|Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.|||percentage of responders||95% Confidence Interval|Number
2718655|NCT01110499|Primary|Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.|Baseline, Day 29|Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2718656|NCT01110499|Primary|Part 1: Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.|Baseline, Day 7|Safety Population: all treated patients|||Millimeters of Mercury (mmHg)|Participants|Standard Deviation|Mean
2718663|NCT01110421|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-To-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.|||Participants|||Number
2719841|NCT01100437|Other Pre-specified|Naltrexone Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2718657|NCT01110421|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
2718658|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
2718659|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
2718660|NCT01110421|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response Rate|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
2718661|NCT01110421|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract (LRT) culture, pleural fluid or blood culture.|||Participants|||Number
2718662|NCT01110421|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical intent-to-treat: All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.|||Participants|||Number
2718685|NCT01110239|Primary|Visual Analog Scale Score as a Measure of Tolerability|The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.|90 days|We escalated the ischemia times in cohorts of 6. Cohorts of 6 were prespecified at the beginning to the study. All analysis was intention to treat|||units on a scale||Standard Deviation|Mean
2718664|NCT01110408|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
2718665|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
2718666|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
2718667|NCT01110408|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
2718668|NCT01110408|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.|||Participants|||Number
2718669|NCT01110408|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.|||Participants|||Number
2718670|NCT01110408|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.|||Participants|||Number
2718678|NCT01110330|Secondary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6|Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either 'Completely Cleared' (clearance of all signs and symptoms of Tinea pedis) or 'Marked Improvement' (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Secondary Outcome Measure.|||participants|||Number
2718686|NCT01110239|Primary|Number of Patients With Deep Vein Thrombosis for Safety Assessment.||90 days||||participants|||Number
2718671|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
2718672|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
2718673|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
2718674|NCT01110382|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
2718675|NCT01110382|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.|||participants|||Number
2718676|NCT01110382|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in WBC, and not received any nonstudy antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.|||participants|||Number
2718677|NCT01110382|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.|||participants|||Number
2718679|NCT01110330|Primary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6|Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary Outcome Measure.|||participants|||Number
2718687|NCT01110200|Secondary|Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population. Only those participants with an EX were assessed for hospitalization, treatment with OCSs, and treatment with ABs.|||exacerbations|||Number
2718688|NCT01110200|Secondary|Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population|||participants|||Number
2718689|NCT01110200|Primary|Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population. Only those participants with an EX requiring hospitalization were assessed.|||Exacerbations|||Number
2718690|NCT01110200|Primary|Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population|||participants|||Number
2718691|NCT01110200|Primary|Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs)|A COPD exacerbation (EX) was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur >21 days post-discharge/physician's office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||participants|||Number
2718692|NCT01110187|Secondary|Number of Participants With Seizures|Number of seizures in the first 72 hours based on EEG recording|baseline to 72 hours||||number of participants with seizures|||Number
2718693|NCT01110187|Primary|Number of Adverse Events|The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.|baseline to 7 days|all participants in each arm were available for analyses|||number of events experienced|||Number
2718694|NCT01110174|Secondary|Correlate Serum Circulating BCa-related Glycan Profiles With Radiographic and Histopathologic Assessments of NAC Response.||Baseline, during and after chemotherapy|PI has left institution, all efforts to locate secondary outcome measure data have been exhausted and there is no longer access to this data.||||||
2718695|NCT01110174|Primary|Assess the Ability of the HD PET/CT to Predict Final Histopathologic NAC Response.|Patients will have a HD PET/CT at baseline and another after the first cycle of NAC and upon completion.The goal is to distinguish NAC responders from non-responders and to accurately identify the size and extent of residual disease.|After the first cycle of Neoadjuvant chemotherapy (NAC)|PI has left the institution, all efforts to locate PI and obtain this information have been exhausted and there is no access to this data||||||
2718696|NCT01110135|Primary|Successful Mobilization and Collection of PBSCs|Count of participants with successful mobilization and collection of PBSCs. Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.|Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride||||Participants|||Count of Participants
2718697|NCT01110005|Secondary|Time to Delivery|Compare time to delivery between the D5LR and LR treatment groups|From onset of labor to delivery||||hours||Inter-Quartile Range|Median
2718698|NCT01110005|Secondary|Oxytocin Augmentation|Compare augmentation rates between the D5LR and LR treatment groups|From onset of labor to delivery||||Participants|||Count of Participants
2718699|NCT01110005|Primary|C-Section|Compare c-section rates between the D5LR and LR treatment groups|From onset of labor to delivery||||Participants|||Count of Participants
2719842|NCT01100437|Other Pre-specified|Morphine Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13|||ng/mL||Standard Deviation|Mean
2718700|NCT01109992|Secondary|Peak Stress Myocardial Blood Flow|Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.|Week 1 (day of the clinical scan), and Week 2 (day of the research scan)|Myocardial blood flow could not be accurately measured in one subject from each arm. Therefore we report information on 10/11 subjects in Regadenoson arm and 29/30 subjects in the Exercise + Regadenoson arm.|||mL/gm/min||Standard Deviation|Mean
2718701|NCT01109992|Secondary|Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET|"Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson).~This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects."|Week 1 (day of the clinical scan), and Week 2 (day of the research scan)||||percentage of LVEF||Standard Deviation|Mean
2718702|NCT01109992|Secondary|Image Quality: Heart to Liver Ratio of Counts|"Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group.~This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects."|Week 1 (day of the clinical scan), and Week 2 (day of the research scan)||||mean ratio||Standard Deviation|Mean
2718703|NCT01109992|Primary|Safety and Tolerability of Combined Exercise and Regadenoson Stress|"Count of subjects with ischemic ECG changes is reported~Count of subjects with systolic blood pressure decrease > 20 mm Hg is reported~Count of subjects with abnormal serum troponin T levels is reported~Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study."|Day of the research scan during the stress test|Radiation dose to staff was not measured due to logistical difficulties.Three subjects had blood pressure changes in the Regadenoson (Lexiscan) arm; 3 subjects showed ischemic ECG changes in the exercise + regadenoson (Lexercise) arm; and, none of the subjects showed abnormal troponin levels.|||Participants|||Count of Participants
2718704|NCT01109979|Primary|Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)|This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors.|%FMD after 6 weeks of treatment|The number of participants for analysis includes only the participants that completed a baseline assessment and at least one of the treatment arms.|||% FMD after 6 weeks of treatment||Standard Deviation|Mean
2718705|NCT01109849|Post-Hoc|Change in BMI z Score During Weight Recovery Period (Second Randomization) Based on Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental BMI increase."|between 1 month and 24 months|all participants prescribed an ER stimulant and also assigned to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 15.|||Z score||Standard Deviation|Mean
2718706|NCT01109849|Post-Hoc|Change in Weight z Score During Weight Recovery Phase (Second Randomization) Based on Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental weight gain."|between 1 month and 24 months|participants using an ER stimualnt and also randomized to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 14.|||zscore||Standard Deviation|Mean
2718713|NCT01109849|Secondary|Change in Height z Score During Weight Recovery Phase (Second Randomization)|"difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain."|between 1 month and 24 months|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. One monitoring participant never prescribed med was excluded.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.|||Z score||Standard Deviation|Mean
2718707|NCT01109849|Post-Hoc|Difference in Height z Score During Weight Recovery Phase (Second Randomization) by Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Larger values reflect greater height change."|between 1 month and 24 months|all participants using an ER stimulant and were also assigned to a weight recovery arm. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 13.|||Z score||Standard Deviation|Mean
2718708|NCT01109849|Post-Hoc|Change in BMI z Score by Actual Medication Usage|measures change in BMI z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a larger BMI|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 3 and 12).|||Z score||Standard Deviation|Mean
2718709|NCT01109849|Post-Hoc|Change in Weight z Score by Actual Medication Usage|measures change in weight z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a greater incremental weight gain.|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 2 and 11).|||Z score||Standard Deviation|Mean
2718710|NCT01109849|Post-Hoc|Change in Height z Score by Actual Medication Usage|measures change in height z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used) med for at least 87.5% of their time in the study with most using the entire time. The inconsistent med group (N=111), used medication between 12.5 to 87.5 of the time (mean time on med was 45% of the time in the study) The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. More negative values reflecting a smaller incremental height gain.|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 1 and 10).|||Z score||Standard Deviation|Mean
2718711|NCT01109849|Secondary|Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)|"difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain."|between 1 month and 24 months|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.|||Z score||Standard Deviation|Mean
2718712|NCT01109849|Secondary|Change in Weight z Score During Weight Recovery Phase (Second Randomization)|"difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain."|1 to 24 months duration|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.|||Z score||Standard Deviation|Mean
2718772|NCT01108835|Secondary|Lung Function|Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.|12 months|Percentage of predicted FEV1|||Percentage of Predicted FEV1||Standard Deviation|Mean
2718714|NCT01109849|Secondary|Number of Behavior Therapy Sessions|Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm|months 0 through 30|those with at least one follow up assessment. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment.|||sessions attended||Standard Deviation|Mean
2718715|NCT01109849|Secondary|Medication Adherence|% of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm.|denominator is number of days in study for which study med was prescribed|any participants with at least one dose of med prescribed. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment.|||% of days dose taken as prescribed|||Number
2718716|NCT01109849|Secondary|ADHD Symptoms- Teacher Rated|sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point.|month 30 or last assessment point|those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization.|||units on a scale||Standard Deviation|Mean
2718717|NCT01109849|Secondary|Change Score for Zheight Months 0 to 6|"in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication.~This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over.~Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain.~If participant dropped out prior to month 6, then the last assessment point was used."|baseline to month 6|participants with at height measurement at month 6|||Z score||Standard Deviation|Mean
2718718|NCT01109849|Secondary|ADHD Symptoms- Parent Rated|sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point.|at month 30 or last collected assessment point|those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization.|||units on a scale||Standard Deviation|Mean
2718719|NCT01109849|Secondary|Treatment Adherence for Caloric Supplement|percent of days caloric supplement were taken versus prescribed in caloric supplement arm|from entry to exit of caloric supplement arm|those assigned to caloric supplement group|||percentage of days||Standard Deviation|Mean
2718720|NCT01109849|Secondary|Change in zBody Mass Index (BMI)|BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time.|baseline to month 30 or last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #12 for change in zBMI from beginning to end of second randomization.|||Z score||Standard Deviation|Mean
2718721|NCT01109849|Secondary|Change Score for z Weight|difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time.|baseline to month 30 or to last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #11 for change in zwt from beginning to end of second randomization.|||Z score||Standard Deviation|Mean
2718722|NCT01109849|Primary|Change Score for Z-height Baseline to Endpoint|"The primary endpoint will be change in z-height at month 30 which is study endpoint.~Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time."|month 30 or last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization. See outcome #10 for change in zht from beginning to end of second randomization.|||Z score||Standard Deviation|Mean
2718723|NCT01109602|Secondary|Quality of Life - Measured With the Stroke Specific Quality of Life|Quality of Life was measured using the validated 49 items of the Stroke Specific QoL scale (SSQoL). The SSQoL includes assessment of 12 domains: self-care; vision; language; mobility; work; upper extremity; thinking; personality; mood; family; social; and energy. Prior work indicates good psychometric properties. Higher scores indicate increased QoL. Range of scores is 13 to 65 for the total score.|2 months||||units on a scale||Standard Deviation|Mean
2718724|NCT01109602|Primary|Balance - Measured With the Berg Balance Scale|Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.|2 months||||units on a scale||Standard Deviation|Mean
2718773|NCT01108835|Secondary|Mortality|From contacting the patient/their family and hospital record retrieval.|12 months||||participants|||Number
2718725|NCT01109602|Secondary|Balance Self-efficacy - Measured With the Activities Balance Confidence Scale|The 16 item Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. The ABC is a self-report of a participant's self-efficacy in maintaining static and dynamic balance control during functional tasks. The validity and reliability of the ABC have been previously demonstrated in individuals with stroke. Scoring is 'no confidence' (0%) to 'completely confident' (100%).|2 months||||units on a scale||Standard Deviation|Mean
2718726|NCT01109576|Primary|Change in Profile of Mood States Total Score.|The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.|Change in Profile of Mood States Score from Baseline to 8 Weeks||||units on a scale||Standard Deviation|Mean
2718727|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population|Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.|||participants|||Number
2718728|NCT01109524|Primary|Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.|||participants|||Number
2718729|NCT01109524|Primary|Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 - 155 mmol/L; Gr 3: >155 - 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:<LLN - 130mmol/L; Gr 3: <130 - 120 mmol/L; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN - 5.5 mmol/L; Gr 2: >5.5 - 6.0 mmol/L; Gr 3: > 6.0 - 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: <LLN - 3.0 mmol/L; Gr 2: <LLN - 3.0 mmol/L; Gr 3: < 3.0 - 2.5 mmol/L; Gr 4: <2.5 mmol/L. Serum creatinine (H) Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.|||participants|||Number
2718730|NCT01109524|Primary|Number of Participants With Hematology Laboratory Abnormalities - Treated Population|Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL.|Day 2 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug. Participants with at least one on-study laboratory measurement available were analyzed.|||participants|||Number
2718731|NCT01109524|Primary|Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Number (N) of participants with laboratory data available and who could be analyzed for total bilirubin was 49. All other liver function laboratories N=57. Treated population: all participants who received at least one dose of any study drug.|||participants|||Number
2718743|NCT01109316|Secondary|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||hyperglycemic episodes per 30 days||Standard Deviation|Mean
2719925|NCT01099761|Primary|Number of Subjects With Adverse Reactions.|Number of subjects in each cohort with a treatment-emergent adverse event considered at least possibly related to study drug|From treatment initiation to End-of-Study Visit, approximately 24 weeks later||||Number of subjects|||Number
2718732|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population|Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.|||participants|||Number
2718733|NCT01109524|Primary|Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.|||participants|||Number
2718734|NCT01109381|Secondary|Assessment of Adverse Events (AE)|Adverse event data will be collected in response to neutral questioning.|AE commencing within 30 days of initiation of treatment, followed until resolution|All participants entering the study are included in the safety analysis|||participants|||Number
2718735|NCT01109381|Primary|Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)|Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).|up to 14 days of treatment|All 21 Initial Phase participants had a pretreatment gastroscopy, and 20 had post-treatment gastroscopy (one participant prematurely discontinued the study prior to receiving GT08, and the participant later lost to follow up had a post-treatment gastroscopy before being lost to follow up)|||participants|||Number
2718736|NCT01109381|Primary|Number of Participants With Eradication of H.Pylori Infection|Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment|4-6 weeks following treatment|Two participants did not complete the study, one discontinuing after experiencing adverse events while receiving only the initial study omeprazole, and the other participant left Singapore before they had their final urea breath test. All other study participants were analysed for efficacy.|||participants|||Number
2718737|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.|||mmHg||Standard Deviation|Mean
2718738|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.|||kilograms (kg)||Standard Deviation|Mean
2718739|NCT01109316|Secondary|Hypoglycemia Episode Rate Per 30 Days|"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||hypoglycemic episodes per 30 days||Standard Deviation|Mean
2718740|NCT01109316|Secondary|Percentage of Participants With Hypoglycemia|"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L)."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||percentage of participants|||Number
2718741|NCT01109316|Secondary|Pump Complication Rate Per 30 Days|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||pump complications per 30 days||Standard Deviation|Mean
2718742|NCT01109316|Secondary|Percentage of Participants With Pump Complications|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||percentage of participants|||Number
2718744|NCT01109316|Secondary|Percentage of Participants With Hyperglycemia|Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||percentage of participants|||Number
2718745|NCT01109316|Secondary|Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%||8 weeks for each treatment|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.|||participants|||Number
2718746|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values||Baseline, 8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2718747|NCT01109316|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.|||Units (U) of insulin||Standard Deviation|Mean
2718748|NCT01109316|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day.|||mmol/L||Standard Deviation|Mean
2718749|NCT01109316|Primary|Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use||8 weeks of each treatment|All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2718750|NCT01109173|Secondary|Percentage of Patients Pain-Free at Day 14|Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.|||percentage of participants|||Number
2718751|NCT01109173|Primary|Percentage of Patients Cured at Day 14|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.|||percentage of participants|||Number
2718752|NCT01109147|Primary|Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)|"During the fMRI session, the activation of each brain circuits is measured by a Bold signal (an arbitrary measure of contrast: numbers of voxels highlighted/activated in the region of interest).~The emotional task is composed by congruent and incongruent images. Three effects were caused by the task: congruence, attention and valence effects. Each of them affect, involve and activate the regions of interests differentially within the differents arms.~The region of interests who were mainly observed are: Anterior Cingulate Cortex (ACC), Prefrontal dorso-lateral Cortex (PFdlC) and the Amygdala (A)."|3 days after the decision of inclusion||||arbitrary units of activation||Standard Error|Mean
2718753|NCT01109147|Secondary|Investigate the Level of Expression of Candidate Genes||one blood sample|||||||
2718754|NCT01109147|Secondary|Assessment of Personality Traits||3 days after the decision of inclusion|||||||
2718755|NCT01109147|Secondary|Assessment of Cognitive and Attentional Abilities||3 days after the decision of inclusion|||||||
2718756|NCT01109147|Secondary|Assessment of Emotional Reactivity||3 days after the decision of inclusion|||||||
2718757|NCT01109108|Primary|Nasopharngeal Colonization With PCV13 S. Pneumoniae|Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae|Study years 1-5|Children colonized with any S. pneumoniae (PCV and non-PCV serotypes)|||Participants|||Count of Participants
2718758|NCT01109056|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16|Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Week 16|Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia|||Scores on a Scale||Standard Deviation|Mean
2718759|NCT01109056|Primary|Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16|Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.|Baseline, Week 16|"Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"|||Scores on a Scale||Standard Deviation|Mean
2718760|NCT01109056|Primary|Number of Pterygium Hyperemia Responders at Week 16|Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.|Week 16|"Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"|||Participants|||Number
2718761|NCT01109004|Secondary|MOS SF-36 Mental Component Summary|The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Deviation|Mean
2718762|NCT01109004|Secondary|MOS SF-36 Physical Component Summary|The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Deviation|Mean
2718763|NCT01109004|Secondary|FACT-BMT Trial Outcome Index|The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Error|Mean
2718764|NCT01109004|Secondary|FACT-BMT Score|The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Error|Mean
2718765|NCT01109004|Secondary|FACT-G Total Score|The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Error|Mean
2718766|NCT01109004|Secondary|Number of Participants With Treatment Response|"The number of participants with very good partial response (VGPR) or better [complete response (CR), near CR (nCR), and stringent CR (sCR)] according to the International Uniform Response Criteria will be calculated. The Worse than VGPR group includes PR, stable disease, and progressive disease.~sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: < 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR >=90% reduction in serum PPN plus urine PPN <100 mg/24hrs, >= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either >= 90% or to <200 mg/24 hours in light chain disease, >= 50% reduction in the size of soft tissue plasmacytomas"|1 and 2 years post-randomization|Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded.|||Participants|||Count of Participants
2718767|NCT01109004|Secondary|Percentage of Participants With Treatment-related Mortality (TRM)|TRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk.|Up to 38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2718768|NCT01109004|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization.|38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2718769|NCT01109004|Secondary|Percentage of Participants With Disease Progression|"Disease Progression is defined as progression of multiple myeloma, including one or more of the following:~A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL~24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours~Abnormal free light chain levels of >10 mg/dl, only in patients without measurable paraprotein in the serum and urine~At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy~Definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of new bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum Ca >11.5 mg/dL or >2.8 mmol/L) not attributable to any other cause~To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk."|38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2718770|NCT01109004|Primary|Percentage of Participants With Progression-free Survival (PFS)|Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.|38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2718771|NCT01108835|Secondary|Exercise Capacity|Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.|12 month||||meters||Standard Deviation|Mean
2718814|NCT01108445|Other Pre-specified|Changes in Copy Number, RNA Expression, and Immunohistochemical Profiles|To evaluate in an exploratory fashion changes in copy number, RNA expression, and immunohistochemical profiles by microarray between primary non-clear cell RCC tumors and metastatic samples|36 months|||||||
2718774|NCT01108835|Secondary|Quality of Life|Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.|12 months||||units on a scale||Standard Deviation|Mean
2718775|NCT01108835|Primary|Hospital Readmission|To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.|12 months||||hospital readmissions||Standard Deviation|Mean
2718776|NCT01108809|Secondary|Number of Patients With Adverse Events (AE)||6 months|Treated patients|||Number of participants|||Number
2718777|NCT01108809|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (6 months)|Patients with data at 3rd visit|||Number of participants|||Number
2718778|NCT01108809|Secondary|Change in Heart Rate From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||beats / minute||Standard Deviation|Mean
2718779|NCT01108809|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)||6 Months|Patients with data at 3rd visit|||Percentage of participants|||Number
2718780|NCT01108809|Secondary|Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|Visit 3 (6 months from baseline)|Patients with data at 3rd visit|||Percentage of participants|||Number
2718781|NCT01108809|Primary|Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End|ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||Percentage of participants|||Number
2718782|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||Percentage of participants|||Number
2718783|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||Percentage of participants|||Number
2718784|NCT01108809|Primary|Change in Diastolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||mmHg||Standard Deviation|Mean
2718785|NCT01108809|Primary|Change in Systolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||mmHg||Standard Deviation|Mean
2718786|NCT01108796|Secondary|Assessment of Metabolic Effect|Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'|24 weeks (Visit 1 to Visit 3)||||Participants|||Number
2718787|NCT01108796|Secondary|Changes in Laboratory Parameters: Blood Glucose|Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
2718788|NCT01108796|Secondary|Changes in Laboratory Parameters: Triglycerides|Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
2718789|NCT01108796|Secondary|Changes in Laboratory Parameters:High Density Lipoprotein (HDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
2718790|NCT01108796|Secondary|Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
2718791|NCT01108796|Primary|Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmHg||Standard Deviation|Mean
2718792|NCT01108796|Primary|Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmHg||Standard Deviation|Mean
2718793|NCT01108757|Primary|Number of Participants With Urinary Tract Infection|Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL|7 days following catheter removal|Study terminated early.|||Participants|||Count of Participants
2718794|NCT01108731|Secondary|Change in Widespread Pain|Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.|2 months|Data from all 26 participants were used for analysis.|||units on a scale||Standard Deviation|Mean
2719843|NCT01100437|Other Pre-specified|Time to First Occurrence of a COWS Score ≥ 13 for Each Treatment During the Treatment Phase|Average time to first occurrence of a COWS score ≥ 13|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hr post-dose and UA|ITT; Subset of participants with COWS >= 13|||h||Standard Error|Mean
2718795|NCT01108731|Secondary|Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).|The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.|Baseline and 2 months|Data from 4 were excluded due to 2 having error rates greater than 50%, indicating that they did not understand the task and 2 having simple reaction times longer than those for the complex reaction times on the ANT, suggesting their need for additional practice trials on the simple motor reaction time task.|||latency to respond (msecs.)||Standard Deviation|Mean
2718796|NCT01108731|Primary|Change in Ventricular Lactate Levels in the Brain|Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.|Baseline and 2 months|One drug treated and two placebo treated could not be analyzed due to excessive head motion|||international units (iu)||Standard Deviation|Mean
2718797|NCT01108718|Primary|Mattress Preference of Fibromyalgia Patients|Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.|6 months|Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.|||percentage of study participants|||Number
2718798|NCT01108523|Secondary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys||4, 8, 12, and 15 days|||||||
2718799|NCT01108523|Primary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.||15 Days|||||||
2718800|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 192||Baseline to Week 192|Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.|||cells/μL||Standard Deviation|Mean
2718801|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 144||Baseline to Week 144|Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.|||cells/μL||Standard Deviation|Mean
2718802|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.|||cells/μL||Standard Deviation|Mean
2718803|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.|||cells/μL||Standard Deviation|Mean
2718804|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.|Week 192|Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.|||percentage of participants|||Number
2718805|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.|Week 144|ITT Analysis Set|||percentage of participants|||Number
2718806|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.|Week 96|ITT Analysis Set|||percentage of participants|||Number
2718807|NCT01108510|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2718808|NCT01108458|Secondary|Proportion of Participants With 50% Decrease in Tumor Marker|Change in tumor marker CA19-9, assessed as a 50% decrease from baseline|3 weeks|||||||
2718809|NCT01108458|Secondary|No. of Events of Drug-related Toxicity|Number of incidences of serious and non-serious drug-related adverse events|3 weeks||||Drug-related adverse events|||Number
2718810|NCT01108458|Secondary|Quality of Life (QoL)|Quality of life as assessed by EORTC QLQ-C30 questionnaire|3 weeks|||||||
2718811|NCT01108458|Secondary|Overall Survival (OS)||1 year|||||||
2718812|NCT01108458|Secondary|Progression-free Survival (PFS)|"Disease status evaluated by computed tomography (CT) scan and progression-free survival assessed per RECIST criteria.~Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported."|9 weeks|||||||
2718813|NCT01108458|Primary|Overall Response Rate by RECIST Criteria||CT imaging every 9 weeks while on protocol|||||||
2718815|NCT01108445|Other Pre-specified|Clinical Measures of Response and PFS With Baseline and Time-dependent Levels of Biomarkers|To correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC|36 months|||||||
2718816|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and end of treatment per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, up to 40 months|All participants who completed the End of treatment visit.|||units on a scale||Standard Deviation|Mean
2718817|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 6 day1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 6 day 1|All participants who completed the cycle 6 day 1 visit.|||units on a scale||Standard Deviation|Mean
2718818|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 3 day 1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 3 day 1|All participants who completed the cycle 3 day 1 visit.|||units on a scale||Standard Deviation|Mean
2718819|NCT01108445|Secondary|Percentage of Participants With Adverse Events|To assess toxicities associated with everolimus or sunitinib using NCI CTC version 4.0 criteria|24 months||||percentage of participants||95% Confidence Interval|Number
2718820|NCT01108445|Secondary|Time-to-new Metastatic Disease in Each Treatment Arm|To compare the time-to-new metastatic disease in each treatment arm, defined from the date of first study agent administration to the onset of a new evaluable site of disease, excluding the primary site and all sites documented at baseline|36 months||||months||95% Confidence Interval|Median
2718821|NCT01108445|Secondary|Median OS|To compare the median OS in each treatment arm.|Up to 40 months||||months||95% Confidence Interval|Median
2718822|NCT01108445|Secondary|Median Duration of Response (CR, PR, and SD)|To compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|24 months||||months||Inter-Quartile Range|Median
2718823|NCT01108445|Secondary|Best Tumor Shrinkage as a Percentile in Each Arm|To compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage.|24 months||||percentile decrease||Inter-Quartile Range|Median
2718824|NCT01108445|Secondary|Overall Survival Rates|To compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm.|6, 12, 24, 36 months||||percentage probability||95% Confidence Interval|Number
2718825|NCT01108445|Secondary|12 Week Clinical Benefit Rate as Percentage|Rate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response [CR] and partial response [PR] and stable disease [SD] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months||||percentage of particpants||95% Confidence Interval|Number
2718826|NCT01108445|Secondary|Percentage of Participants With Stable Disease (SD)|Percentage of participants with stable disease during treatment is defined as stable disease [SD] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months||||percentage of participants||95% Confidence Interval|Number
2718827|NCT01108445|Secondary|Overall Response Rate|Defined as complete response [CR] and partial response [PR] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|24 months||||percentage of participants||95% Confidence Interval|Number
2718828|NCT01108445|Secondary|PFS Expressed in Months|Progression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 months||||Months||95% Confidence Interval|Median
2718829|NCT01108445|Secondary|Progression Free Survival Rates|6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|6, 12 and 24 months||||percentage of participants||95% Confidence Interval|Number
2718830|NCT01108445|Primary|Anti-tumor Activity as Measured by Median Progression Free Survival Time|The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 Months||||Months||80% Confidence Interval|Median
2718831|NCT01108406|Secondary|Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) , a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).|3 months and 6 months||||Global Benefit Score||Standard Deviation|Mean
2718832|NCT01108406|Primary|Long Term Safety|The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.|6 months||||participants|||Number
2718833|NCT01108341|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|up to Week 32|Safety population of participants who were treated|||percentage of participants||95% Confidence Interval|Number
2718834|NCT01108341|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|up to Week 32|Safety population of participants who were treated|||percentage of participants||95% Confidence Interval|Number
2718835|NCT01108263|Secondary|Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.||12 weeks||||participants|||Number
2718836|NCT01108263|Primary|Overall Decrease in Wound Size||12 weeks||||participants|||Number
2718837|NCT01108237|Secondary|Sagittal Component Alignment||Pre-Op, 3 months|||||||
2718838|NCT01108237|Secondary|Compare AP Tibial/Femoral Component Alignment||Pre-op, 3 months|||||||
2718839|NCT01108237|Secondary|Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone)||During the Procedure|||||||
2718840|NCT01108237|Primary|Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films|Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.|12 weeks postoperatively (when subject has reached full knee extension)||||Absolute value in degrees||Standard Deviation|Least Squares Mean
2718841|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
2718842|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.|Day 0|The per-protocol population was analyzed.|||Participants|||Number
2718843|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.|Day 10 - 16||||Participants|||Number
2719138|NCT01106534|Primary|Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2718844|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.|Day 0|The per-protocol population was analyzed.|||Participants|||Number
2718845|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.|Day 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
2718846|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.|Day 0|The per-protocol population was analyzed.|||Participants|||Number
2718847|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.|||Percentage|||Number
2718848|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.|Day 0|The per-protocol population was analyzed.|||Percentage|||Number
2718849|NCT01108185|Primary|The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events|The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.|Day 0 through Days 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
2718850|NCT01108185|Primary|Compliance (Was the Dosage Followed - Yes, no)|Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.|Day 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
2718851|NCT01108094|Secondary|Tumor Response|"The following criteria for basal cell carcinoma (BCC) tumor response were used.~Complete response (CR) means no visible evidence of any lesion consistent with BCC~Partial response (PR) means less than CR, but there was a visible decrease in BCC tumor size~No response (NR) / Stable Disease (SD) means no visible decrease in BCC tumor size~Progressive disease (PD) means an increase in size or number of BCC tumor lesions~Treatment assessment was conducted on the basis of lesion photographs by a dermatologist investigator who was blinded to the assigned treatment."|End of treatment period: 1 month (Cohort A) or 2.3 months (mean for Cohort B)||||Participants|||Count of Participants
2718852|NCT01108094|Secondary|Tumor Size|Tumor size was assessed by caliper measurement of the longest perpendicular diameters before and after itraconazole treatment, and determination of tumor area by multiplication of the measurements for each tumor. The outcome is expressed as the mean percent change in tumor area from baseline, with standard deviation. A negative value indicates a reduction in size.|Up to 3 months|Change in tumor area was assessed for only for Cohort A1 or B participants who had > 1 basal cell carcinoma (BCC) tumor (42 and 14 lesions respectively). No Cohort A2 participants had > 1 BCC tumor. No data were collected from untreated patients.|||Mean percent change|Basal Cell Carcinoma (BCC) lesions|Standard Deviation|Mean
2718853|NCT01108094|Secondary|Change of GLI1 Tumor Biomarker|Tumor biomarker GLI1 (glioma-associated oncogene 1), part of the Hedgehog (HH) pathway, was assessed in vismodegib-naïve participants at baseline and after 1 month of treatment by quantitative polymerase chain reaction (qPCR). The relative expression of the biomarker was measured as the fold increase of GLI1 expression compared to that of housekeeping gene hypoxanthine-guanine phosphoribosyltransferase (HPRT), and the outcome was assessed as the percent change from the mean of the pre-treatment measurements to the mean of the post-treatment measurements. A negative mean indicates an overall reduction in GLI1 expression.|1 month|Analysis conducted for Cohorts A1 - Itraconazole 400 mg (Vismodegib-naive) and A2 - Itraconazole 400 mg (Prior Vismodegib) only. GLI1 tumor biomarker assessment was not performed for the Cohort B (100 mg twice daily); or Control Group.|||Percent change|Basal Cell Carcinoma (BCC) lesions|Standard Deviation|Mean
2718854|NCT01108094|Primary|Ki67 Tumor Proliferation Biomarker|"Percent change in Ki67 tumor proliferation biomarker was assessed at baseline and after 1 month of treatment, for Cohort A1 (vismodegib-naïve participants receiving 400 mg as 200 mg twice daily) vs control patients. The outcome is expressed as the % change from baseline of cells with a positive signal after staining for Ki67.~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients, & is reported as the mean of the changes observed for those lesions for which both baseline and treated valued are available.~Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients, and is reported as the change in mean of the group of baseline basal cell carcinoma (BCC) lesion measurements and the group of treated BCC lesion measurements."|1 month|Ki67 tumor proliferation biomarker assessment was not performed for Cohorts A2 (itraconazole 400 mg & prior vismodegib) and B (itraconazole 100 mg twice daily).|||Mean percent change|Basal Cell Carcinoma (BCC) lesions|Standard Deviation|Mean
2718855|NCT01108081|Secondary|Change Over 6 Months in Quality of Life|Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Functional Outcomes of Sleep Questionnaire scores. One participant in Diet arm and one participant in Health education arm.|||units on a scale||Standard Error|Mean
2718856|NCT01108081|Primary|Change Over 6 Months in Epworth Sleepiness Scale Score|Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Epworth Sleepiness Scale scores. One participant in Diet arm and one participant in Health education arm.|||units on a scale||Standard Error|Mean
2718857|NCT01108068|Secondary|pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium|"The Z-score indicates the number of standard deviations away from the mean of age matched controls. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-score indicates a favorable outcome.Z-score of pQCT variable was noted for the in two OPPG participants who received lithium and were also able to get pQCT scans. The n of 2 was too small to do statistical analyses. Of the 5 OPPG who were on lithium, 2 were too small for the machine (eventhough over age 4) and 1 had rods in his legs and couldn't have pQCT"|baseline, 6 months|Two OPPG participants who took lithium for 6 months and were able to do pQCT at baseline and 6 months. First number is baseline, 2nd number is 6 months for section modulus|||Z-score||Standard Deviation|Mean
2718858|NCT01108068|Primary|pQCT of Lower Leg|pQCT will be done at baseline for all OPPG participants and unaffecteds. The Z-score indicates the number of standard deviations away from the mean of age matched controls. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-score indicates a favorable outcome.|Baseline|in OPPG, 2 were too small for pQCT machine and 2 had hardware in legs. For 2 in unaffecteds there were technical difficulties with the pQCT scanner|||Z-score||95% Confidence Interval|Mean
2718859|NCT01108055|Secondary|Median Overall Survival (OS) by Bellmunt Score|"Comparison between the participant's baseline Bellmunt prognostic risk factor score and survival rates.~The Bellmunt prognostic risk factor score is a tool that is often used to predict treatment outcomes before initiating a secondline treatment regimen.~The risk factors used to calculate the Bellmunt score include:~Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1~Presence of liver metastases~Presence of visceral involvement (defined as liver, lung, bone or any non-lymph node)~Lymph node-only involvement~Hemoglobin concentration < 10 g/dL~The score is calculated based on the presence of 0; 1; 2; or 3 of the above prognostic factors. This outcome reports median overall survival based on whether the participant had 0; 1; 2; or 3 prognostic factors."|4 years|Include all 32 participants, regardless of completing 2 cycles of treatment.|||Months||Full Range|Median
2718860|NCT01108055|Secondary|Overall Survival|Overall survival is reported as the median survival of the evaluable subjects (ie, completed 2 cycles of treatment).|4 years|Does not include participants who did not complete 2 cycles of treatment.|||Months||95% Confidence Interval|Mean
2718861|NCT01108055|Secondary|Overall Response Rate|"The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:~Complete response (CR) = Disappearance of all target lesions~Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet above criteria Tumor response rate by each response criteria."|4 years|Does not include participants who did not complete 2 cycles of treatment.|||Participants|||Count of Participants
2718862|NCT01108055|Secondary|Progression-free Survival (PFS)||4 years||||Months||95% Confidence Interval|Median
2718863|NCT01108055|Primary|Objective Tumor Response|"The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:~Complete response (CR) = Disappearance of all target lesions~Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR)."|Every 8 weeks|The outcome is reported as subjects with CR (complete response) + PR (partial response).|||Participants|||Count of Participants
2718864|NCT01108003|Secondary|Apoptosis, Cell Proliferation, and Microvessel Density||1 year|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2718865|NCT01108003|Primary|Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0|Number of participants with an adverse event.|14 days|All treated and eligible patients.|||participants|||Number
2718866|NCT01107964|Secondary|Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45|"Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability.~Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value)."|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||time in seconds|eyes|Inter-Quartile Range|Median
2718867|NCT01107964|Secondary|Change From Baseline of Lissamine Green Staining Score at Day 45|Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||units on a scale|eyes|Inter-Quartile Range|Median
2720887|NCT01092663|Primary|Hemoglobin A1C|Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments|Baseline and 12 weeks||||percentage||Standard Deviation|Mean
2718868|NCT01107964|Secondary|Change From Baseline of Schirmer-1 Test Value at Day 45|Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||millimeters|eyes|Inter-Quartile Range|Median
2718869|NCT01107964|Primary|Change From Baseline of the Ocular Surface Disease Index Score at Day 45|The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||units on a scale|eyes|Inter-Quartile Range|Median
2718870|NCT01107925|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy|MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline , Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percent aggregation||Standard Deviation|Mean
2718871|NCT01107925|Secondary|Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)|A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|baseline (pre-dose) up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.|||nanogram•hour/milliliter (ng•hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
2718872|NCT01107925|Secondary|Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||P2Y12 reaction units (PRU)||Standard Deviation|Mean
2718873|NCT01107925|Secondary|Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy|VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percentage PRI||Standard Deviation|Mean
2718874|NCT01107925|Primary|Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)|MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|Primary intent-to-treat (ITT) pharmacodynamic (PD) population: all randomized participants who continued in the study through Day 12, and had at least 1 evaluable PD assessment at Day 12. Participants were analyzed based on the treatment group they were randomized to irrespective to the treatment they received.|||percent aggregation||Inter-Quartile Range|Median
2718875|NCT01107912|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percentage of aggregation||Standard Deviation|Mean
2718886|NCT01107899|Secondary|Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD|Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements.|||percentage of participants|||Number
2720888|NCT01092637|Secondary|Number of Survivors With Cerebral Palsy|Number of participants diagnosed with Cerebral Palsy|7 years 3 months|Number of participants with cerebral palsy|||participants|||Number
2718876|NCT01107912|Secondary|Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing|A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|Baseline up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.|||nanogram*hour/milliliter (ng*hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
2718877|NCT01107912|Secondary|Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||P2Y12 reaction units (PRU)||Standard Deviation|Mean
2718878|NCT01107912|Secondary|Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy|Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percentage platelet reactive index (PRI)||Standard Deviation|Mean
2718879|NCT01107912|Primary|Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.|Baseline, 12 days|All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.|||percentage of aggregation||Inter-Quartile Range|Median
2718880|NCT01107899|Secondary|Platelet Function by Multiplate® ADP Test and ADP Test HS|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM PGE1 (ADP test HS), area under the aggregation curve (AUC) were calculated.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.|||aggregation units*minute||Standard Deviation|Mean
2718881|NCT01107899|Secondary|Platelet Function by LTA at 5 and 20 μM ADP|MPA to 5 and 20 μM ADP were assessed by LTA.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.|||percent aggregation||Standard Deviation|Mean
2718882|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by Multiplate® ADP Test and ADP Test High Sensitivity (HS)|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADP test HS), area under the aggregation curve (AUC) was calculated. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
2718883|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hours Post-LD) by LTA (5 and 20 μM ADP)|Maximum platelet aggregation (MPA) to 5 and 20 μM ADP were assessed by LTA. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
2718884|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)|Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU*min) of aggregation units (AU).|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.|||Aggregation Units * minutes||90% Confidence Interval|Mean
2718885|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)|Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day.|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.|||percent platelet aggregation||90% Confidence Interval|Mean
2718902|NCT01107834|Primary|Left Ventricular Mass Index|left ventricular mass index measured by 2D echocardiography|Baseline||||g/m2||Standard Deviation|Mean
2718887|NCT01107899|Secondary|Platelet Function 24 Hours Post Loading Dose|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.|||P2Y12 Reaction Units (PRU)||Standard Deviation|Mean
2718888|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
2718889|NCT01107899|Secondary|Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU|To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at 24 hours post LD]/PRU at baseline) x 100%.|Up through 11 days|ITT Washout Population: All randomized participants who received study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. One participant discontinued on Day 3 without returning to baseline and is not included in analysis.|||days|||Number
2718890|NCT01107899|Secondary|Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)|The return of baseline platelet function following one LD of prasugrel (30 mg or 60 mg) or 600 mg LD of clopidogrel assessed by Verify Now™ P2Y12 Reaction Units (VN-PRU). This outcome measure was not analyzed because it was not appropriate to estimate the days based on the non-inferiority approach due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
2718891|NCT01107899|Secondary|The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7|The day at which the proportion of participants who return to baseline platelet P2Y12 receptor function in the prasugrel 30 mg and 60 mg LD groups is similar (within 10% absolute difference) to the proportion of subjects who return to baseline platelet P2Y12 receptor function at day 5 and day 7 in the clopidogrel 600 mg LD group, obtained from Kaplan Meier curves for the primary washout population, was to be presented. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||day|||Number
2718892|NCT01107899|Secondary|The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel|This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days|||Number
2718893|NCT01107899|Primary|Percentage of Participants Returning to Baseline Platelet Function|Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.|Days 3, 5, 7, 9, and 11|Primary Washout Population: Included participants who completed the study, had evaluable pharmacodynamic (PD) data through Day 11. Participants with a missed visit were not included in the Primary Washout Population.|||percentage of participants|||Number
2718894|NCT01107886|Secondary|Participants With Event of Death|Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.|||participants|||Number
2718895|NCT01107886|Secondary|Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation|Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.|||participants|||Number
2718896|NCT01107886|Primary|Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke|Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.|||participants|||Number
2718897|NCT01107834|Secondary|Myocardial Wall Velocity During Early Diastole|Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging|Baseline||||cm/s||Standard Error|Mean
2718898|NCT01107834|Secondary|Early to Late Diastolic Filling Ratio|Early to late diastolic filling ratio measured by tissue Doppler echocardiography|Baseline||||ratio, unitless||Standard Deviation|Mean
2718899|NCT01107834|Secondary|Systolic Myocardial Velocity During Systole (S')|Systolic myocardial velocity during systole measured by tissue Doppler echocardiography|Baseline||||cm/s||Standard Deviation|Mean
2718900|NCT01107834|Secondary|Global Strain Rate|Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography|Baseline||||percentage of full deformation||Standard Deviation|Mean
2718901|NCT01107834|Primary|Fractional Shortening|Fractional shortening measured by M-mode cardiography|Baseline||||percentage of full contraction||Standard Deviation|Mean
2718903|NCT01107795|Primary|Improvement in Apnea Hypopnea Index (AHI) Score|Improvement in Apnea Hypopnea Index (AHI) score, as measured by a polysomnogram sleep study. The AHI score is the number of apnea events per hour, with a lower score indicating mild sleep apnea and a higher score indicating severe sleep apnea. An improved AHI score would be a lower score at 6 months than at 3 months and baseline.|Baseline, 3 months, 6 months|Participant attrition rate was very high; no data were collected.||||||
2718904|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718905|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718906|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718907|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718908|NCT01107743|Secondary|Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718909|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718910|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718911|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718912|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718913|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718914|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718915|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, Class1, Class2, Class3, or Class4 is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718916|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718917|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718918|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718919|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718920|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718921|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718922|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718923|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718924|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718925|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718926|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718927|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2719980|NCT01099215|Secondary|Number of Patients Requiring Reintervention of Target Lesion / Target Vessel|Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel|up to 48 Weeks from study procedure|Intention-to-Treat Population Analysis|||participants|||Number
2718928|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718929|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718930|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718931|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718932|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718933|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718934|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718935|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 years is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718936|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718937|NCT01107743|Secondary|Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718938|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718939|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718940|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2718941|NCT01107743|Primary|Number of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.|8 weeks|The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2718942|NCT01107730|Primary|Incidence of Postoperative Atrial Fibrillation|The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.|Within the first 30 days (plus or minus 3 days)||||participants|||Number
2718943|NCT01107665|Other Pre-specified|(BRAF) Mutation Status vs Survival|Comparison of OS between BRAF mutant subset and BRAF WT/unknown group.|Up to 36 months|Stage III/IV melanoma|||months||95% Confidence Interval|Median
2718944|NCT01107665|Other Pre-specified|In Vitro Response of Tumor Cells Grown in Culture With Vascular Endothelial Cells to Pazopanib, Paclitaxel, Topotecan and Resveratrol|In vitro response of tumor cells grown in culture with vascular endothelial cells to pazopanib, paclitaxel, topotecan and resveratrol. There are no results for this exploratory endpoint due to cuts in funding.|Day 1|Exploratory endpoints were not analyzed due to depletion of funds.||||||
2718945|NCT01107665|Other Pre-specified|Tissue Levels of Angiogenic Markers Including Protein (p)53, HIF, Cluster of Differentiation (CD)31, Neuronal Nitric Oxide Synthase (nNOS), TSP1, and VEGF|Categorical statistical analysis will be performed to determine the relationship between PD and PK markers and outcomes. Univariate summary statistics will be calculated, such as the sample median, standard deviation, minimum, and maximum observations. The dichotomized variables were tabulated as high and low levels or positive and negative expression. Changes over time in continuously distributed biomarker levels will be investigated with the sign's test because of the heavy degree of skewness observed in some of the marginal distributions. There are no results for this exploratory endpoint due to cuts in funding.|Day 1|Exploratory endpoints were not analyzed due to depletion of funds.||||||
2718946|NCT01107665|Other Pre-specified|Concentrations of Plasma Proteins (Serum VEGF, Soluble VEGF Receptor 2, Serum Hypoxia-inducible Factor (HIF) and Serum TSP1) That May be Associated to Angiogenesis and Tumor Proliferation|Categorical statistical analysis will be performed to determine the relationship between PD and pharmacokinetic (PK) markers and outcomes. Univariate summary statistics will be calculated, such as the sample median, standard deviation, minimum, and maximum observations. The dichotomized variables were tabulated as high and low levels or positive and negative expression. Changes over time in continuously distributed biomarker levels will be investigated with the sign's test because of the heavy degree of skewness observed in some of the marginal distributions. There are no results for this exploratory endpoint due to cuts in funding.|Day 1|Exploratory endpoints were not analyzed due to depletion of funds.||||||
2718947|NCT01107665|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters|"AEs and toxicities will be graded according to the National Cancer Institute-common toxicity criteria (NCI-CTC), Version 3.0. Summaries of the number of toxicity grades for both laboratory and non-laboratory data will be presented. If the AE is listed in the NCI-CTC, the maximum grade will be summarized. Otherwise, the maximum intensity will be summarized. AEs will be coded using the standard dictionary (MedDRA), and grouped by system organ class. They will be summarized by frequency and proportion of total subjects, by system organ class and preferred term. Separate summaries will be given for all AEs, for drug-related AEs, for SAEs, and for AEs leading to withdrawal from the study treatment. The incidence of deaths will also be reported.~Please refer to the Adverse Event table for specifics."|From baseline until date of first documented progression, until initiation of a subsequent anti-cancer therapy, until death, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years|Please refer to the Adverse Event tables for specifics.|||Participants|||Count of Participants
2718948|NCT01107665|Secondary|Duration of Response (DR)|"Duration of response analyses will be restricted to the subgroup of the population who experience a response during the study. Duration of response will be defined as the time from first documented evidence of response (CR/PR) until the first documented sign of disease progression or death, if sooner. For subjects who do not progress or die, duration of response will be censored on the date of last assessment.~Duration of response will be summarized using the Kaplan-Meier method."|Time from first documented evidence of response (CR/PR) until the first documented sign of disease progression or death, assessed up to 2 years|Duration of response analyses will be restricted to the subgroup of the population who experience a response during the study. Duration of response will be defined as the time from first documented evidence of response (CR/PR) until the first documented sign of disease progression or death, if sooner.|||days||Standard Deviation|Mean
2718949|NCT01107665|Secondary|Clinical Benefit Response (CBR)|"This is defined as the percentage of subjects achieving either a complete (CR), partial tumor (PR) or stable disease (SD) response per RECIST criteria. Confirmation will occur at least 4 weeks after the initial response for partial and complete responders. Stable disease will also be defined by 8 weeks or greater.~Subjects in the ITT population with unknown or missing response will be treated as non-responders, i.e. they will be included in the denominator when calculating the percentage. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD or the persistence of one ore more non-target lesions; Clinical Benefit Rate = (SD+PR+CR)."|Up to 2 years||||percentage of participants|||Number
2720889|NCT01092637|Secondary|Number of Survivors Without Disability|IQ =>85, no neurological abnormalities, normal hearing, normal vision|7 years 3 months|Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified.|||participants|||Number
2718950|NCT01107665|Secondary|Objective Response Rate (ORR)|This is defined as the percentage of subjects achieving either a complete or partial tumor response per RECIST criteria. The response rate will be calculated from the review of best response which records confirmed cases of PR and CR only. Confirmation will occur at least 4 weeks after the initial response. Stable disease (SD) will also be defined by 8 weeks or greater and will be summarized by less than 6 months vs. equal or greater than 6 months. Subjects in the ITT population with unknown or missing response will be treated as non-responders, i.e. they will be included in the denominator when calculating the percentage. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of target lesions; Overall Reponse (ORR) = CR + PR.|Up to 2 years||||percentage of participants|||Number
2718951|NCT01107665|Secondary|Percentage of Participants Alive at 2 Years|This is defined as the percentage of subjects who are alive at 2 years after enrollment. For subjects who do not die, time to death will be censored at the time of last contact.|At 2 years after enrollment||||percentage of participants|||Number
2718952|NCT01107665|Secondary|Percentage of Participants Alive at 1 Year|This is defined as the percentage of subjects who are alive at 1 year after enrollment. For subjects who do not die, time to death will be censored at the time of last contact.|At 1 year after enrollment||||percentage of participants|||Number
2718953|NCT01107665|Primary|Percentage of Participants With Progression-free Survival at 6 Months|This is defined as the percentage of subjects who are free of RECIST-defined objective disease progression at 6 months after study treatment start. Subjects in the Intent-to-Treat (ITT) population who discontinue the study prior to 6 months will be included in the denominator when calculating the percentage. Progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|6 Months||||percentage of participants|||Number
2718954|NCT01107535|Secondary|Number of Serious Adverse Events|The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.|Enrollment until 100 days after the last Synagis (palivizumab) dose|Analysis included all enrolled participants.|||participants|||Number
2718955|NCT01107535|Secondary|Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission|The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.|Hospital admission to hospital discharge|Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).|||days||Standard Deviation|Mean
2718956|NCT01107535|Secondary|Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection|The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|Hospital admission to hospital discharge|Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.|||days|||Number
2718957|NCT01107535|Secondary|Number of Hospital Admission Days (All Causes)|The mean (average) number days participants were hospitalized.|Hospital admission to hospital discharge|Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.|||days||Standard Deviation|Mean
2718958|NCT01107535|Primary|Number of Hospital Admissions by Respiratory Syncytial Virus Infection|The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|First year of life (up to 12 months)|Analysis included all enrolled participants.|||participants|||Number
2718959|NCT01107457|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|"The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant.~Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.|||units on a scale||Standard Deviation|Mean
2718960|NCT01107457|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 240|All enrolled participants who had PASI 75 response at Week 20.|||percentage of participants|||Number
2719020|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included all participants who provided essential PK data up to and including the pre-dose PK sample taken on Cycle 1, Day 22, without major protocol violation.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
2718961|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis|The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.|Baseline Up to 240 Weeks|All enrolled participants with baseline palmoplantar psoriasis.|||units on a scale||Standard Deviation|Mean
2718962|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis|"The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.~Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants with baseline scalp psoriasis.|||units on a scale||Standard Deviation|Mean
2718963|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis|"The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing.~Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants with baseline nail psoriasis.|||units on a scale||Standard Deviation|Mean
2718964|NCT01107457|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.|Baseline Up to 240 Weeks|All enrolled participants with data available.|||Millimeters (mm)||Standard Error|Mean
2718965|NCT01107457|Secondary|Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been)."|Week 240|All enrolled participants who had PASI 75 response at Week 20.|||Participants|||Count of Participants
2718966|NCT01107457|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.|||units on a scale||Standard Deviation|Mean
2718967|NCT01107457|Secondary|Number of Treatment Emergent Adverse Events up to 344 Weeks|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 344 Weeks|All enrolled participants.|||Participants|||Count of Participants
2718968|NCT01107457|Secondary|Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.|||percentage of participants|||Number
2718969|NCT01107457|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 20|All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.|||percentage of participants|||Number
2718977|NCT01107457|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12|The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2718970|NCT01107457|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Week 32|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. Zero participants in the placebo arm had data.|||percentage of participants|||Number
2718971|NCT01107457|Secondary|Percentage of PASI Improvement From Baseline Through 32 Weeks|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.|Baseline Through 32 Weeks|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Zero participants in the placebo arm had data.|||Percentage PASI improvement||Standard Deviation|Mean
2718972|NCT01107457|Secondary|Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 32|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||percentage of participants|||Number
2718973|NCT01107457|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12|PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region*area score*weighing factor (head[0.1],upper limbs[0.2],trunk[0.3],lower limbs [0.4]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718974|NCT01107457|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16|The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718975|NCT01107457|Secondary|Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)|The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.|Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||liters per hour (L/hr)||95% Confidence Interval|Mean
2718976|NCT01107457|Secondary|Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12|The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2718978|NCT01107457|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12|The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2718979|NCT01107457|Secondary|Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718980|NCT01107457|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718981|NCT01107457|Secondary|Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))|The PMRU is a 3‑item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.|Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.|||participants|||Number
2718982|NCT01107457|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16|MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718983|NCT01107457|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||millimeter (mm)||95% Confidence Interval|Least Squares Mean
2718984|NCT01107457|Secondary|Change From Baseline in Patient Global Assessment (PatGA) at Week 12|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model."|Baseline, 12 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718985|NCT01107457|Secondary|Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718986|NCT01107457|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16|The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2718987|NCT01107457|Secondary|Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 20 Weeks|All randomized participants who received at least 1 dose of study drug.|||Participants|||Number
2718988|NCT01107457|Secondary|"Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement at Week 12"|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||percentage of participants|||Number
2718989|NCT01107457|Primary|Percentage of PASI Improvement From Baseline to 12 Week Endpoint|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline to Week 12|All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.|||Percentage of improvement in PASI score||95% Confidence Interval|Least Squares Mean
2718990|NCT01107457|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||percentage of participants|||Number
2718991|NCT01107444|Secondary|Lung Cancer Symptom Scale (LCSS) Average Total Score at Cycle 2 Day 1|The worsening of symptoms was defined as a 15-millimeter (mm) increase in any 1 symptom on the Lung Cancer Symptom Scale (LCSS). The LCSS is an assessment used to evaluate 6 major symptoms associated with lung malignancies and their effect on 3 overall symptomatic items: distress, functional activities and global quality of life. LCSS consists of 2 scales: 1 completed by the participant and 1 completed by the health care professional (which is the average symptom burden index [ASBI]). Participant-reported outcomes are assessed using 9 visual analog scales (100-mm horizontal line). Participants indicate intensity of response to the items in question (0 = lowest rating, 100 = highest rating). The LCSS total score ranges from 0 (lowest rating) to 100 (highest rating) and was defined as the mean over all 9 items.|Cycle 2 Day 1|Participants who received at least 1 dose of study drug and had evaluable LCSS data.|||units on a scale||Inter-Quartile Range|Median
2719015|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg/mL||Standard Deviation|Mean
2718992|NCT01107444|Secondary|Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) on Cycle 2 Day 1|The worsening of symptoms was defined as a 15-millimeter (mm) increase in any 1 symptom on the Lung Cancer Symptom Scale (LCSS). The LCSS is an assessment used to evaluate 6 major symptoms associated with lung malignancies and their effect on 3 overall symptomatic items: distress, functional activities and global quality of life. LCSS consists of 2 scales: 1 completed by the participant and 1 completed by the health care professional (which is the average symptom burden index [ASBI]). Participant-reported outcomes are assessed using 9 visual analog scales (100-mm horizontal line). Participants indicate intensity of response to the items in question (0 = lowest rating, 100 = highest rating). The LCSS total score ranges from 0 (lowest rating) to 100 (highest rating) and was defined as the mean over all 9 items. ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome).|Cycle 2 Day 1|Participants who received at least 1 dose of study drug and had evaluable LCSS data.|||units on a scale||Inter-Quartile Range|Median
2718993|NCT01107444|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date of documented progressive disease (PD) or death. Complete response (CR) was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions. Duration of response was censored at the date of the last assessment or follow-up visit for responders who were still alive and had not progressed.|Time of response to progressive disease (PD) (approximately 8.7 months)|Participants who received at least 1 dose of study drug and achieved CR or PR. A total of 0 participants were censored in the Docetaxel arm; 2 participants were censored in the LY2181308 + Docetaxel arm.|||Months||90% Confidence Interval|Median
2718994|NCT01107444|Secondary|Percent of Participants Having a Partial Response (PR) or a Complete Response (CR)|Complete response (CR) was defined as the disappearance of all target lesions; partial response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Randomization to the first date of progressive disease (up to 12.1 months)|Participants who received at least 1 dose of study drug. A total of 47 participants were censored in the Docetaxel arm; 107 participants were censored in the LY2181308 + Docetaxel arm.|||Percentage of participants|||Number
2718995|NCT01107444|Secondary|Time to Documented Disease Progression|Time to documented disease progression was defined as the time from the date of randomization to the first date of documented progression. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to documented disease progression was censored at the date of the last assessment visit for participants who had not had documented progressive disease as of the data cut-off date.|Randomization to the first date of progressive disease (up to 12.9 months)|Participants who received at least 1 dose of study drug. A total of 15 participants were censored in the Docetaxel arm; 38 participants were censored in the LY2181308 + Docetaxel arm.|||Months||90% Confidence Interval|Median
2718996|NCT01107444|Secondary|Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR)|Time to objective tumor response was defined as the time from the date of randomization to the first date of documented objective tumor response. Time to objective tumor response was censored at the date of the last assessment visit for participants who had not had documented response as of the data cut-off date. Complete response (CR) was defined as the disappearance of all target lesions; partial response (PR) was defined as at least a 30% decrease in sum of the longest diameter of target lesions.|Randomization to the date of first response (up to 12.1 months)|Participants who received at least 1 dose of study drug. A total of 47 participants were censored in the Docetaxel arm; 107 participants were censored in the LY2181308 + Docetaxel arm.|||Months||90% Confidence Interval|Median
2718997|NCT01107444|Secondary|Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire|The worsening of symptoms was defined as a 15-millimeter (mm) increase in any 1 symptom on the LCSS. The LCSS is an assessment used to evaluate 6 major symptoms associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global quality of life. LCSS consists of 2 scales: 1 completed by the participant and 1 completed by the health care professional (which is the average symptom burden index [ASBI]). Participant-reported outcomes are assessed using 9 visual analog scales (100-mm horizontal line). Participants indicate intensity of response to the items in question (0 = lowest rating, 100 = highest rating). The LCSS total score ranges from 0 (lowest rating) to 100 (highest rating). The LCSS total score was defined as the mean over all 9 items. Time to worsening of symptoms was censored at the date of the last assessment visit for participants who did not experience any worsening of symptoms as of the data cut-off date.|Baseline to the worsening of symptoms (up to 4.6 months)|Participants who received at least 1 dose of study drug. A total of 10 participants were censored in the Docetaxel arm; 26 participants were censored in the LY2181308 + Docetaxel arm.|||Months||90% Confidence Interval|Median
2718998|NCT01107444|Secondary|Overall Survival (OS)|Overall survival (OS) was the duration from enrollment to death from any cause. For participants who were alive, OS is censored at the date of last contact.|Randomization to date of death from any cause (up to 21.6 months)|Participants who received at least 1 dose of study drug. A total of 20 participants were censored in the Docetaxel arm; 41 participants were censored in the LY2181308 + Docetaxel arm.|||months||90% Confidence Interval|Median
2718999|NCT01107444|Secondary|Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel|Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel|Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4,5,505,513,2521 hours(h);LY2181308 + Docetaxel: C1 D -1:3,4 h;D1:0,3,4,5,5.25,5.75,7,8,120,504,507,509,1008,1512,1515,1517,2016, 2520,2523,2525 h|Participants who received at least 1 dose of study drug and who had an interpretable pharmacokinetic profile|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2719000|NCT01107444|Secondary|Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel|Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 hours (AUC[0-4]) for LY2181309 and Docetaxel|Docetaxel: Cycle(C)1 Day(D)1:0,1,1.25,1.75,3,4 hours(h);LY2181308 + Docetaxel: C1 D-1:3,4 h;D1:0,3,4 h|Participants who received at least 1 dose of study drug and who had an interpretable pharmacokinetic profile|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2719001|NCT01107444|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. PFS time was censored at the date of the last assessment visit for participants who were still alive and who did not have documented progressive disease as of the data cut-off date.|Randomization to the first date of progressive disease or death from any cause (up to 12.88 months)|Participants who received at least 1 dose of study drug. A total of 10 participants were censored in the Docetaxel arm; 18 participants were censored in the LY2181308 + Docetaxel arm.|||Months||95% Confidence Interval|Median
2719002|NCT01107444|Secondary|Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding|"Safety analyses included listings and/or summaries of the following:~CTCAE for laboratory and non-laboratory parameters possibly related to study drug;~CTCAE Grades 3 and 4 for laboratory and non-laboratory parameters possibly related to study drug (Grade 3 - severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4 - life-threatening consequences; urgent intervention indicated);~Dose adjustments due to adverse events (AEs)."|Randomization through long-term follow up (up to 21.6 months)|Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2719003|NCT01107444|Primary|Change From Baseline in Tumor Size to the End of Cycle 2|The tumor size was defined as the sum of the longest diameters for the target lesions. The sum of lesion diameters was calculated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. The log ratio of tumor size at the end of Cycle 2 to tumor size at baseline was calculated for each participant.|Baseline, End of Cycle 2 (1 cycle = 21 days)|Participants who received at least 1 dose of study drug and had tumor size measurements (according to the pre-specified inclusion criteria) at baseline and at the end of Cycle 2.|||Log Ratio of Tumor Size||Standard Deviation|Mean
2719004|NCT01107418|Primary|Accumulation Ratio of Vemurafenib on Day 15|Accumulation ratio was calculated as, AUC(0-8) on Day 15 divided by AUC(0-8) on Day 1.|Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1 and 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||ratio||Standard Deviation|Mean
2719005|NCT01107418|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug administration to the date of death, regardless of the cause of death.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
2719006|NCT01107418|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response. Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) were required to demonstrate a reduction to normal (short axis less than [<] 10 millimeters [mm]). PR was defined as a 30 percent (%) decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of confirmed CR or PR are reported.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Efficacy population: all enrolled participants who received at least one dose of vemurafenib, had measurable target lesions at baseline based on RECIST 1.1 criteria, had no major protocol violations of inclusion/exclusion criteria, and had no other violations affecting efficacy assessments.|||percentage of participants|||Number
2719007|NCT01107418|Primary|Terminal Elimination Half-Life (t1/2) of Vemurafenib on Day 15|Time measured for vemurafenib plasma concentrations to decrease by one-half (t1/2) was calculated as 0.693 divided by apparent first-order terminal elimination rate constant (0.693/kel).|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||hours||Standard Deviation|Mean
2719008|NCT01107418|Primary|Apparent Clearance (CL/F) of Vemurafenib on Day 15|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||liters/hour (L/h)||Standard Deviation|Mean
2719009|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||hours||Full Range|Median
2719010|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg/mL||Standard Deviation|Mean
2719011|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC[0-168h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
2719012|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
2719013|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
2719014|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||hours||Full Range|Median
2719021|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (initial challenge)|Visit 4 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
2719022|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (initial challenge)|Visit 4 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
2719023|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 3 (initial challenge)|Visit 3 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
2719024|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 3 (initial challenge)|Visit 3 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
2719025|NCT01107405|Primary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||Units on a scale||Standard Deviation|Mean
2719026|NCT01107405|Primary|Ocular Itching|Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Ocular Itching Scores – Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||Units on a Scale||Standard Deviation|Mean
2719027|NCT01107392|Secondary|Duration of Effect|Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points.|24 Weeks|Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis.|||Weeks||95% Confidence Interval|Median
2719028|NCT01107392|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.|Baseline, Weeks 6, 12 and 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure.|||mL/sec||Standard Deviation|Mean
2719029|NCT01107392|Secondary|Change From Baseline in the Total International Prostate Symptom Score (IPSS)|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 6, Week 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.|||Score on a scale||Standard Deviation|Mean
2719030|NCT01107392|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.|||Score on a scale||Standard Deviation|Mean
2719031|NCT01107379|Primary|Mean Intra-patient Change in Lund-Mackay CT Scan Score|"Change in Lund-Mackay CT score for paired baseline and 24 week data.~The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.|||Scores on a scale||Standard Deviation|Mean
2719032|NCT01107379|Secondary|Mean Number of Days to Return to Normal Activities|Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living|2 weeks|Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.|||days||Standard Deviation|Mean
2719033|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.|Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.|Day 0 (Day of Procedure)||||number of sinuses|Participants||Number
2719034|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary|Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary|Day 0 (Day of Procedure)||||number of sinuses|Participants||Number
2719036|NCT01107379|Primary|Mean Intra-patient Change in SNOT-20 Score|"Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.~The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.|||Scores on a scale||Standard Deviation|Mean
2719037|NCT01107353|Primary|Bioequivalence Determined by Statistical Comparison Cmax|Blood samples were collected pre-dose and at intervals over 120 hours after each dose|33 Days||||ng/mL||Standard Deviation|Mean
2719038|NCT01107197|Secondary|the Percentage of Change in Area|the reduction in ulcer area (%) observed at 4 weeks|4 weeks of nutritional support (baseline and week 4)||||percent change||Inter-Quartile Range|Median
2719039|NCT01107197|Secondary|Dressings|The number of dressings used throughout the intervention period|8 weeks of nutritional support (baseline and week 8)||||dressings||Standard Deviation|Mean
2719040|NCT01107197|Secondary|Cost-effectiveness|Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active - control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).|8 weeks of nutritional support (baseline and week 8)||||Euros||Standard Deviation|Mean
2719041|NCT01107197|Secondary|Incidence of Infections|defined as local (ulcer)|8 weeks of nutritional support (baseline and week 8)||||participants|||Number
2719042|NCT01107197|Secondary|Rate of Healing|complete healing|8 weeks of nutritional support (baseline and week 8)||||participants|||Number
2719043|NCT01107197|Secondary|Rate of Healing|reduction in ulcer area >=40%|8 weeks of nutritional support (baseline and week 8)||||participants|||Number
2719044|NCT01107197|Primary|Rate of Healing|healing is defined as reduction in ulcer area (the percentage of change)|8 weeks of nutritional support (baseline and week 8)||||percent change||Standard Deviation|Mean
2719045|NCT01107015|Primary|HBA1c at One Year||one year||||percentage of HbA1c||Standard Deviation|Mean
2719046|NCT01106976|Primary|AChE PET Neuroimaging|AChE PMP PET hydrolysis rate outcome measure. AChE [11C]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.|4 yr|Parkinson disease.|||1/min||Standard Deviation|Mean
2719047|NCT01106950|Secondary|Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion|Association between in vivo natural killer (NK) cell expansion and complete response without platelet recovery (CRp) with donor killer immunoglobulin-like (KIR) genotype and Treg depletion. In vivo donor NK cell expansion was correlated with regulatory T-cell (Treg) depletion as detected on flow cytometry.|Day 14||||Percentage of patients|||Number
2719048|NCT01106950|Secondary|Number of Patients With Treatment-Related Death|Number of patients who died within the first 100 days of treatment due to toxicity.|Day 100||||Percentage of patients|||Number
2719049|NCT01106950|Secondary|Percent of Patients With Incidence of Relapse|Number of patients who have had a relapse(the return of disease after its apparent recovery/cessation) after obtaining a complete remission of their disease.|Month 6||||Percentage of patients|||Number
2719050|NCT01106950|Secondary|Percent of Patients With Disease Free Survival|Number of patients alive and disease free at 6 months. The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|Month 6||||Percentage of patients|||Number
2719051|NCT01106950|Secondary|Percent of Patients With Complete Remission of Disease|Disease response was defined as complete remission (disease response) by morphologic criteria including <5% blasts in a moderately cellular or cellular marrow. Complete remission was also correlated with NK cell expansion in vivo, IL-15 levels and donor/recipient KIR B genotyping, and Treg depletion.|At least 4 weeks after last dose (28 days)||||Percentage of patients|||Number
2719052|NCT01106950|Primary|Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion|The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/ul in the patient's peripheral blood 14 days after infusion.|Day 14||||Percentage of patients|||Number
2719053|NCT01106911|Primary|Number of Participants Without Cancer Who Were Recalled|Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.|upon recruitment/enrollment phase completion|Includes only participants who were not diagnosed as having a breast malignancy.|||participants|||Number
2719054|NCT01106898|Primary|Recurrence-free Survival|Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.|Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years||||percentage of subjects||95% Confidence Interval|Number
2719066|NCT01106833|Secondary|SF-36 Mental Component Summary|The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||score on a scale||Standard Error|Mean
2719055|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population|||proportion|||Number
2719056|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 3.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 3.5 cm and <= -3.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 3.5 cm, and an improved performance is when the difference of SDLP < -3.5 cm.|3-9 hours post dose|Intent to treat population|||participants|||Number
2719057|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population|||proportion|||Number
2719058|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.0 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.0 cm and <= -2.0 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.0 cm, and an improved performance is when the difference of SDLP < -2.0 cm.|3-9 hours post dose|Intent to treat population|||participants|||Number
2719059|NCT01106859|Primary|Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population|||proportion|||Number
2719060|NCT01106859|Primary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.|3-9 hours post dose|Intent to treat population|||participants|||Number
2719061|NCT01106859|Secondary|Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)|Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness (summarized as 'unrelated' and 'related') to study treatment. Also included are counts of participants with serious AEs, AEs leading to discontinuation of study treatment, and deaths.|Day 1 -6 weeks|Safety population (participants who were randomized and received at least one dose of study drug)|||participants|||Number
2719062|NCT01106859|Secondary|Mean Standard Deviation of Speed (SDS) in the Highway Drive Test|Mean standard deviation of speed (SDS) is a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed are recorded and analyzed.|3-9 hours post dose|Intent to treat population. In one Zopiclone case, the velocity of the car was not recorded due to technical problems, and therefore SDS could not be calculated in this drive.|||kilometers/hour||Standard Error|Least Squares Mean
2719063|NCT01106859|Secondary|Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test|Standard deviation of lateral position (SDLP) in a highway-driving lane is a surrogate measure for driving performance. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed.|3-9 hours post dose|Intent to treat population|||centimeters||Standard Error|Least Squares Mean
2719064|NCT01106846|Primary|Quality of Recovery Score Post Operative at 24 Hours|Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.|24 hours post operative||||units on scale||Standard Deviation|Mean
2719065|NCT01106833|Secondary|FACT-BMT Score|The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.|Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||score on a scale||Standard Error|Mean
2719067|NCT01106833|Secondary|SF-36 Physical Component Summary|The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||score on a scale||Standard Error|Mean
2719068|NCT01106833|Secondary|NIH Consensus Criteria Chronic GVHD Severity|Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe.|Baseline, 6 months, 1 year, and 2 years post-randomization|Outcomes are analyzed in participants that were alive and whose clinical assessments were completed.|||Participants|||Count of Participants
2719069|NCT01106833|Secondary|Provider-reported Chronic GVHD Severity|Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.|Baseline, 6 months, 1 year, and 2 years post-randomization|Outcomes are analyzed in participants that were alive and whose providers completed assessments.|||Participants|||Count of Participants
2719070|NCT01106833|Secondary|Patient-reported Chronic GVHD Severity|Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.|Baseline, 6 months, 1 year, and 2 years post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||Participants|||Count of Participants
2719071|NCT01106833|Secondary|Change in Serum Creatinine Level From Baseline|Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.|6 months and 1 year post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/dL||Full Range|Median
2719072|NCT01106833|Secondary|Serum Creatinine Level|Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization.|Baseline, 6 months, and 1 year post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/dL||Full Range|Median
2719073|NCT01106833|Secondary|Change in Prednisone Dose From Baseline|Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.|6 months and 1 year post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/kg/day||Full Range|Median
2719074|NCT01106833|Secondary|Prednisone Dose|Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization.|Baseline, 6 months, and 1 year post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/kg/day||Full Range|Median
2719075|NCT01106833|Secondary|Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years|The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint.|2 years post-randomization||||percentage of participants||95% Confidence Interval|Number
2719076|NCT01106833|Secondary|Percentage of Participants With Secondary Immunosuppressive Therapy Initiated|The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint.|6 months and 24 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2719077|NCT01106833|Secondary|Percentage of Participants With Relapse|Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint.|6 months and 24 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2719078|NCT01106833|Secondary|Percentage of Participants With Failure-free Survival|Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint.|6 months and 24 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2719079|NCT01106833|Secondary|Percentage of Participants With Progression-free Survival|Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint.|6 months and 24 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2719080|NCT01106833|Secondary|Percentage of Participants With Overall Survival|Overall survival is defined as survival of death from any cause.|6 months and 24 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2719081|NCT01106833|Primary|Proportion of Participants With Treatment Success|Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.|6 months and 24 months post-randomization|Twelve participants withdrew study consent between 6 and 24 months post-randomization, so are excluded from the analysis of treatment success at 24 months.|||Participants|||Count of Participants
2719082|NCT01106690|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719133|NCT01106534|Secondary|ST for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2720890|NCT01092637|Primary|Number of Survivors With an IQ > 84|IQ was measured using WPPSI III core tests|7 years 3 months|Children for whom IQ data at age 6-7 yr were available|||participants|||Number
2719083|NCT01106690|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719084|NCT01106690|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
2719085|NCT01106690|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719086|NCT01106690|Secondary|Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26|HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||HOMA2-%B||Standard Error|Least Squares Mean
2719087|NCT01106690|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2719088|NCT01106690|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2719089|NCT01106690|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719090|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719091|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719134|NCT01106534|Secondary|MACE for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2719135|NCT01106534|Secondary|Major Bleeding for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2719092|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
2719093|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719094|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2719095|NCT01106677|Secondary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719096|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719097|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719098|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
2719099|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719100|NCT01106677|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2719136|NCT01106534|Secondary|ST for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2720891|NCT01092559|Primary|Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation||through Treatment Period||||participants|||Number
2719101|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2719102|NCT01106677|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2719103|NCT01106677|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719104|NCT01106651|Secondary|Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719105|NCT01106651|Secondary|Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719106|NCT01106651|Secondary|Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719107|NCT01106651|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719108|NCT01106651|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719109|NCT01106651|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719137|NCT01106534|Secondary|MACE for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2719110|NCT01106651|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
2719111|NCT01106651|Secondary|Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719112|NCT01106651|Secondary|Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719113|NCT01106651|Secondary|Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||kg||Standard Error|Least Squares Mean
2719114|NCT01106651|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719115|NCT01106651|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2719116|NCT01106651|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2719117|NCT01106651|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719118|NCT01106625|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719119|NCT01106625|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719120|NCT01106625|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
2719121|NCT01106625|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2719122|NCT01106625|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2719123|NCT01106625|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2719124|NCT01106625|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2719125|NCT01106586|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).|||percentage of participants|||Number
2719126|NCT01106586|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.|||cells/µL||Standard Deviation|Mean
2719127|NCT01106586|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT analysis set|||percentage of participants|||Number
2719128|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 modified intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.|||percentage of participants|||Number
2719129|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set|||percentage of participants|||Number
2719130|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set|||percentage of participants|||Number
2719131|NCT01106586|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2719132|NCT01106534|Secondary|Major Bleeding for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2719140|NCT01106534|Primary|Incidence of Composite of All Death, MI and Stroke (Defined as MACE)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
2719141|NCT01106456|Primary|7-Day Point Prevalence Abstinence From Smoking for 6 Months|The primary outcome of the study was salivary cotinine-verified 7-day point prevalence smoking abstinence at 6 months (Have you smoked at least part of a cigarette in the past 7 days?) using responders-only analyses.|6 months|"The difference in the overall number of participants analyzed, from the number analyzed, in the ANBL arm, is due to missing data."|||Participants|||Count of Participants
2719142|NCT01106430|Secondary|Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1|UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||participants|||Number
2719143|NCT01106430|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||participants|||Number
2719144|NCT01106430|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
2719145|NCT01106430|Secondary|Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
2719146|NCT01106430|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2719147|NCT01106430|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2719148|NCT01106430|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||percentage of participants|||Number
2719149|NCT01106430|Primary|Time to First Response|Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle.|||Days||95% Confidence Interval|Median
2719150|NCT01106404|Secondary|NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant|"The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning No pain and 10 meaning Pain as bad as you can imagine, accompanied by the instructions Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours. The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits."|Baseline, 10 weeks and 16 weeks post-implant|69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly.|||units on a scale||Standard Deviation|Mean
2719151|NCT01106404|Secondary|Manual Adjustments Presented as Button Presses|The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.|Baseline, 10 weeks and 16 weeks post-implant|Subjects with manual adjustments data from patient programmer were included in the analysis.|||Button presses per day||Standard Deviation|Mean
2721675|NCT01085214|Primary|Overall Response Rate|Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).|Up to 2 years|All participants who received study treatment|||participants|||Number
2719152|NCT01106404|Secondary|Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming|"The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded much worse pain relief with AdaptiveStim or somewhat worse pain relief with AdaptiveStim."|16 weeks post-implant|A total of 71 subjects with completed data were included in this analysis.|||percentage of participants|||Number
2719153|NCT01106404|Primary|Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm|After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.|16 weeks post-implant|"The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective.~No imputation method was used for 71 subjects included in the completed case analysis."|||percentage of participants|||Number
2719154|NCT01106391|Primary|Rate of Primary Safety Endpoint Within 1 Month Post-procedure.|Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.|One month follow-up|The analysis population consists of subjects with complete core laboratory data at 1 month.|||participants|||Number
2719155|NCT01106391|Primary|Rate of Technical Success Through the One Month Follow up.|Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.|From procedure to one month follow up|All enrolled subjects|||participants|||Number
2719156|NCT01106352|Other Pre-specified|Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain|The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain.|From start of study treatment until 12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||Participants|||Number
2719157|NCT01106352|Other Pre-specified|Overall Survival Rate|The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
2719158|NCT01106352|Other Pre-specified|Progression Free Survival (PFS) End Point|PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
2719159|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Clinical or Radiographic Progression|"Time to first radiologic or clinical progression is determined by one of the following:~For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1.~For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression."|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
2719160|NCT01106352|Other Pre-specified|Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85|CTCs were measured to follow the evolution of the level of CTCs after treatment.|Baseline, Day 85, expanded safety cohort|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||Percent Change||Standard Deviation|Mean
2719161|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression|Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
2719162|NCT01106352|Other Pre-specified|Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers|Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1|From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||mcg/L||Standard Deviation|Mean
2719163|NCT01106352|Primary|Number of Subjects With Signs of Long-Term Radiation Toxicity|Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia).|From start of study treatment upto 12 months|Only participants who received treatment were assessed|||Participants|||Number
2719164|NCT01106352|Primary|Number of Subjects With Physical Examination During the Treatment Period|Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table.|From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||Participants|||Number
2719165|NCT01106352|Primary|Changes From Baseline in Weight During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||kilogram(s)||Standard Deviation|Mean
2719166|NCT01106352|Primary|Changes From Baseline in Heart Rate During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||beats per min||Standard Deviation|Mean
2719167|NCT01106352|Primary|Changes From Baseline in Respiratory Rate During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||breaths/min||Standard Deviation|Mean
2719168|NCT01106352|Primary|Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2719169|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||tetra per liter (TI/L)||Standard Deviation|Mean
2719170|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||giga per liter (GI/L)||Standard Deviation|Mean
2719171|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||millimole(s)/liter||Standard Deviation|Mean
2719172|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||micromole(s)/litre||Standard Deviation|Mean
2719173|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||units per liter (U/L)||Standard Deviation|Mean
2719174|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period|In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only randomized participants who have this outcome measure tested were assessed|||gram per liter (G/L)||Standard Deviation|Mean
2719208|NCT01106092|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719175|NCT01106352|Primary|Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEs|Only participants who received treatment were assessed|||Participants|||Number
2719176|NCT01106352|Primary|Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part|DLT was defined as - Absolute neutrophil count grade greater than or equal to (>=) 4 (Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0: less than [<] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade >= 4 (CTCAE, v4.0: < 25× 109/L) lasting longer than 7 days. Diarrhea Grade >= 3 (CTAE, v4.0: increase of >= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade >= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade >= 3 (CTCAE, v4.0).|From randomization until 6 weeks post-injection in all dose cohort of dose-escalation part||||Participants|||Number
2719177|NCT01106326|Secondary|Additional Asthma Morbidity Measures|We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.|2 month, 4 month, final follow-up assessments|||||||
2719178|NCT01106326|Primary|Number of Symptom-free Days Over Two Weeks|We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.|2 and 4 month follow-up assessments|Analysis conducted per protocol.|||Days||Standard Deviation|Mean
2719179|NCT01106287|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Only treatment-emergent adverse events were examined for this outcome measure.|Up to 6 weeks after the first dose of study drug|All participants receiving any dose of MK-0941 of placebo.|||participants|||Number
2719180|NCT01106287|Primary|Number of Participants Who Experienced One or More Adverse Events During the Study||Up to 30 days after the last dose of study drug|All participants receiving any dose of MK-0941 or placebo|||participants|||Number
2719181|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Time to Maximum Observed Plasma Concentration (Tmax).|Pharmacokinetic profile of eribulin mesylate (tmax).|Days 1 and 8|Pharmacokinetic Population|||hours||Full Range|Median
2719182|NCT01106248|Secondary|To Further Explore the Safety and Tolerability of Eribulin Mesylate When Administered on Days 1 and 8 of a 21-day Cycle in Patients With Solid Tumors.||21 day cycle|||||||
2719183|NCT01106248|Secondary|To Assess Best Overall Response Using RECIST Criteria in Patients With Measurable Disease.||21 day cycle|||||||
2719184|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Observed Maximal Plasma Concentration (Cmax)|Pharmacokinetic profile of eribulin mesylate (Cmax).|Days 1 and 8|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
2719185|NCT01106248|Primary|Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.|The primary endpoint is mean time-matched, baseline corrected QTcF at any time point postdosing. This was to determine the effect of eribulin on cardiac repolarization as measured by QT/QTc interval.|48 hours postdose after Day 1 and after Day 8|Per Protocol Population|||msec||Standard Deviation|Mean
2719186|NCT01106157|Secondary|Change in White Blood Count (WBC) From Baseline to 12 Months|Change in WBC over 12 months|Change from baseline to 12 months||||Change in percentage of WBC||Standard Deviation|Mean
2719187|NCT01106157|Secondary|Percentage of Neutrophils|Change in Neutrophil Count over 12 months|Change from baseline to 12 months||||Percentage of neutrophils||Standard Deviation|Mean
2719188|NCT01106157|Secondary|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) From Baseline to 12 Months|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) over 12 months|Change from baseline to 12 months||||nmol/L||Standard Deviation|Mean
2719189|NCT01106157|Secondary|Change in Insulinoma Associated 2 Autoantibodies (IA-2A) From Baseline to 12 Months|Change in Insulinoma Associated 2 Autoantibodies (IA-2A)|Change from baseline to 12 months||||nmol/L||Standard Deviation|Mean
2719190|NCT01106157|Secondary|Change in Insulin Autoantibodies (IAA) From Baseline to 12 Months|Change in Insulin Autoantibodies (IAA) over 12 months|Change from baseline to 12 months||||Units/mL||Standard Deviation|Mean
2719191|NCT01106157|Secondary|Change in Glutamic Acid Decarboxylase Antibodies (GADA) From Baseline to 12 Months|Change in Glutamic Acid Decarboxylase Antibodies (GADA) over 12 months|Change from baseline to 12 months||||nmol/L||Standard Deviation|Mean
2719192|NCT01106157|Secondary|Change in Insulin Requirements, Baseline to 12 Months|Change in Insulin Requirements, baseline to 12 months|Change from baseline to 12 months|Insulin use data was not provided by all subjects resulting in sampling for analysis that was smaller than the cohort for the entire study.|||units/kg/day||Standard Deviation|Mean
2719193|NCT01106157|Secondary|A1c|Change in A1c baseline to 12 months|Change in baseline to 12 months||||% change||Standard Deviation|Mean
2719194|NCT01106157|Secondary|Percent Change in Regulatory T Cells (Treg) Baseline to 12 Months|Change in regulatory T cells (Treg) baseline to 12 months|Change in Baseline to 12 months||||percentage change||Standard Deviation|Mean
2719209|NCT01106092|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.|Prior to booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719195|NCT01106157|Primary|Change in Metabolic Function Baseline to 12 Months.|Area Under Curve (AUC) C-peptide production. Subjects underwent a 2 hour mixed meal tolerance test (MMTT) using a 6ml/kg load of boost to stimulate insulin production. Samples were collected at baseline, 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, and 120 minutes. AUC was then calculated. Subjects repeated the MMTT at baseline, 3, 6, 9, and 12 months following ATG/GCSF or placebo. The primary outcome for the study was the change over 12 months in AUC C-peptide (1 year - baseline) for those who received ATG/GCSF versus the change in AUC C-peptide (1 year - baseline) for those who received placebo|Baseline and 12 months||||nmol/L/min||Standard Deviation|Mean
2719196|NCT01106092|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2719197|NCT01106092|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2719198|NCT01106092|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2719199|NCT01106092|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2719200|NCT01106092|Secondary|Number of Subjects With a Booster Response for Anti-BPT|Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719201|NCT01106092|Secondary|Anti-BPT Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2719202|NCT01106092|Secondary|Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)|Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719203|NCT01106092|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2719204|NCT01106092|Secondary|Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)|Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.|||Participants|||Count of Participants
2719205|NCT01106092|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2719206|NCT01106092|Secondary|Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)|Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719207|NCT01106092|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2719210|NCT01106092|Secondary|Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3|Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719211|NCT01106092|Primary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2719212|NCT01106092|Primary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2719213|NCT01106092|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.|One month after booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2719214|NCT01106040|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
2719215|NCT01106040|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
2719216|NCT01106027|Primary|Number of Subjects With Acute Humoral Rejection (AHR) up to One Year Post Transplant.|Diagnosis of AHR will be based histological findings using Banff '05 criteria.|1 year posttransplant|The one subject who completed the study did not have acute humoral rejection. The other subject had the transplant but lost the graft early, meeting one of the endpoints of the study.|||Participants|||Count of Participants
2719217|NCT01106014|Secondary|Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)||Week 26|Full analysis set. Patients with WHO FC IV at baseline were excluded from this analysis as they could not shift to a worse category|||Percentage of patients|||Number
2719218|NCT01106014|Secondary|Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough|The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day.|Week 26|Full analysis set|||Meters||Full Range|Median
2719219|NCT01106014|Primary|Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake|"Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points).~Morbidity event was defined as any of the following events confirmed by the Critical Event committee:~Hospitalization for worsening of pulmonary arterial hypertension (PAH),~Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy,~Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH,~Disease progression which was defined by a decrease in 6-minute walk distance from baseline (>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline.~Note: The number of patients at risk decreased over time but this cannot be captured below"|Up to 7 days after end of double-blind treatment (maximum: 4.3 years)|The primary endpoint was analyzed using the full analysis set, which includes all randomized patients evaluated according to the study drug to which they have been randomized (intention-to treat analysis set).|||Percentage of patients free of events||95% Confidence Interval|Number
2719220|NCT01105975|Secondary|Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score|EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline up to Week 18|Participants who had both baseline and at least one post-baseline EQ-5D measurements, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2719221|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 bicarbonate measurements.|||milliequivalents/Liter||Standard Error|Least Squares Mean
2719222|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Sodium|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 sodium measurements.|||milliequivalents/Liter||Standard Error|Least Squares Mean
2719223|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Potassium|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 potassium measurements.|||milliequivalents/Liter||Standard Error|Least Squares Mean
2719224|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 renin activity measurements.|||nanograms/milliliter/hour (ng/mL/h)||Standard Error|Least Squares Mean
2719225|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 aldosterone measurements.|||nanogram/deciliter (ng/dL)||Standard Error|Least Squares Mean
2719226|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 BP measurements.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2719227|NCT01105975|Secondary|The Number of Episodes of Rashes at Any Time From Baseline Through Week 12|All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.|Baseline through Week 12|Participants who took study drug.|||events|||Number
2719228|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 CETP mass measurements.|||percent change of micrograms/mL (mcg/mL)||Standard Error|Least Squares Mean
2719229|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 CETP activity measurements.|||percent change of picomoles/mL/minute||Standard Error|Least Squares Mean
2719230|NCT01105975|Secondary|Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State||Baseline up to 12 weeks|Participants who were administered LY2484595 and had pharmacokinetics (PK) samples.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2719231|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 LDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
2719232|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 HDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
2719233|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 LDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
2719234|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 HDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
2719235|NCT01105975|Primary|Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 LDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
2719236|NCT01105975|Primary|Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 HDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
2719237|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]|"Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine."|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
2719238|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]|"Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine."|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
2719239|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]|"Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine."|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
2719240|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]|"Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine."|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
2719241|NCT01105936|Secondary|Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]|"Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine."|Baseline and post-dose before stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
2719242|NCT01105936|Secondary|BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution|Baseline to 2-5 hours post last dose administration|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Z-score||Standard Deviation|Mean
2719243|NCT01105936|Primary|Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.|Baseline to 2-5 hours post last dose administration|Intention-to-treat (ITT) population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Z-score||Standard Deviation|Mean
2719244|NCT01105767|Primary|Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI||At the end of the 20 month study||||participants|||Number
2719245|NCT01105767|Primary|Incidence of Skin and Soft Tissue Infection (SSTI)||At the end of the 20 month study||||participants|||Number
2719246|NCT01105754|Secondary|Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.|The number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.|2 week follow-up, and medical record review||||participants|||Number
2719247|NCT01105754|Primary|Symptom Free Days|The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.|2 month follow-up assessment||||Days||Standard Deviation|Mean
2719248|NCT01105702|Secondary|Number of Patients With Grade 3 or 4 Adverse Events|Adverse events evaluated per CTCAE 3|The whole time while on treatment and 30 days after the treatment|all the patients with treatment|||participants|||Number
2719249|NCT01105702|Secondary|Median Overall Survival (OS)|OS defined as time from diagnosis to most recent follow up or death.|Up to 50 months|intent-to-treat population|||months||95% Confidence Interval|Median
2719250|NCT01105702|Primary|Median Progression-Free Survival (PFS)|PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).|Up to 50 months|Intent-to-treat population|||months||95% Confidence Interval|Median
2719251|NCT01105650|Secondary|Overall Survival|Number of participants alive at 1 year.|1 Year||||participants|||Number
2719254|NCT01105650|Primary|Response Rate|Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.|Month 3||||participants|||Number
2719255|NCT01105533|Other Pre-specified|Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, food effect on AUC (0-24) was not assessed.||||||
2719256|NCT01105533|Secondary|Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25|Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT])|Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25|Results are not reported as the data were not statistically summarized but available in individual participant listing.||||||
2719257|NCT01105533|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline, every 8 weeks up to Cycle 25 (Week 100)|Full Analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2719258|NCT01105533|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, CL was not calculated.||||||
2719259|NCT01105533|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Vss was not calculated.||||||
2719260|NCT01105533|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0 - ∞) was not calculated.||||||
2719261|NCT01105533|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0-24) was not calculated.||||||
2719262|NCT01105533|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, t1/2 was not calculated.||||||
2719263|NCT01105533|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Cmax was not calculated.||||||
2719264|NCT01105533|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg twice daily|||Number
2719273|NCT01105312|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|from baseline up to 5 years post-registration|13 of the 16 phase II patients were treated and analyzed|||months||95% Confidence Interval|Median
2719265|NCT01105533|Primary|Maximum Administered Dose (MAD)|MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg once daily|||Number
2719266|NCT01105533|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg once daily|||Number
2719267|NCT01105533|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Baseline up to Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2719268|NCT01105377|Secondary|Time to Progression|Time to disease progression (TTP) is defined as the time from the start of treatment to the earliest of the date documenting disease progression or most recent assessment for patients having no progression. The distribution of TTP is estimated using the method of Kaplan-Meier.|From the start of treatment to the earliest of the date documenting disease progression, assessed up to 3 years|Analysis for this endpoint was “per protocol” and two participants were excluded. One participant in Cohort I was ineligible and one participant in Cohort II refused to start their 1st cycle of study treatment (ie, cancelled). Therefore, 23 participants in Cohort I and 22 participants in Cohort II were analyzed for this secondary endpoint.|||months||95% Confidence Interval|Median
2719269|NCT01105377|Primary|Confirmed Tumor Response|Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to <1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation, compared to pre-treatment measurements. The confirmed response rate is calculated as the number of confirmed CR+PR, divided by the total number of evaluable patients, with 95% confidence intervals estimated using the approach of Duffy and Santner.|At 6 month evaluation|Analysis was performed “per protocol” using only Cohort II participants, except those deemed ineligible, cancelled, or in major treatment violation during cycle 1. One of the 23 Cohort II participants was excluded in the analysis due to cancelling before initiating treatment.|||percentage of participants||95% Confidence Interval|Number
2719270|NCT01105312|Secondary|Confirmed Response Rate (Phase I)|A confirmed response is defined to be a CR or PR (as determined by RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The number of confirmed responses will be reported here.|from baseline up to 5 years|All 12 eligible phase I patients were treated and analyzed.|||Participants|||Count of Participants
2719271|NCT01105312|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is defined as the time from the date of registration to the date at which the patient is removed from treatment due to progression, unacceptable adverse events, or refusal. The distribution of TTF will be estimated using the method of Kaplan-Meier|from baseline up to 5 years post-registration|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
2719272|NCT01105312|Secondary|Clinical Benefit Rate|Clinical benefit rate will be estimated by the total number of patients with an objective status of CR, PR, or SD for duration of at least 6 months divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.|||percentage of participants||95% Confidence Interval|Number
2719288|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population|||participants|||Number
2719274|NCT01105312|Secondary|Progression-free Survival (Phase II)|Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. PFS at 6 months will be estimated. The distribution of PFS will be estimated using the method of Kaplan-Meier.|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
2719275|NCT01105312|Secondary|Time-to-disease Progression (Phase II)|"Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of TTP will be estimated using the method of Kaplan-Meier. Progression is defined as at least one of the following:~At least one new malignant lesion or a lymph node whose short axis has increased to >1.5 cm~At least a 20% increase in the sum of diameters of target lesions taking as reference the MSD. In addition, the sum must also demonstrate an absolute increase of at least 0.5 cm"|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
2719276|NCT01105312|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|from baseline up to 5 years post-registration|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
2719277|NCT01105312|Primary|Response Rate (Phase II)|"A confirmed response is defined to be a CR or PR (as determined by RECIST (version 1.1 criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.~A CR is defined as:~All of the following must be true:~Disappearance of all non-nodal target lesions~Each target lymph node must have reduction in short axis to <1.0 cm~A PR is defined as:~At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the BSD (Section 11.41)"|from baseline up to 5 years post-registration|13 of the 16 patients enrolled were eligible, treated, and analyzed for this endpoint.|||percentage of participants||95% Confidence Interval|Number
2719278|NCT01105312|Primary|Maximum-tolerated Dose (Phase I)|MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 > new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. The number of DLT's will be reported here.|Up to 2.5 months|All 12 phase I patients were eligible and analyzed for MTD.|||Participants|||Count of Participants
2719279|NCT01105247|Secondary|Percentage of Participants Achieving Response|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).||||Percentage of Participants||95% Confidence Interval|Number
2719280|NCT01105247|Secondary|Progression Free Survival Rate at 24 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).||||Percentage of Participants||95% Confidence Interval|Number
2719281|NCT01105247|Secondary|Food Effect Cohort Assessments|Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.|Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.|Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.|||||90% Confidence Interval|Number
2719282|NCT01105247|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AEs.|From first dose to within 30 days of last dose of PCI-32765||||Participants|||Number
2719283|NCT01105130|Secondary|Assessment of Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT_P) questionnaire. The FACT questionnaire is comprised of four subscales - social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.|8 weeks|All participants who completed the FACT_P at any time.|||units on a scale||Standard Error|Least Squares Mean
2719284|NCT01105130|Secondary|Adherence|Adherence is the percentage of prescribed pills taken by the participants|8 weeks|Participants who returned pill diaries.|||percentage of prescribed pills||Full Range|Mean
2719285|NCT01105130|Secondary|Retention|Retention is the percentage of participants who complete the 8 week visit.|8 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2719286|NCT01105130|Primary|International Index of Erectile Function (IIEF)|The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.|8 weeks|All participants providing data at any time.|||units on a scale||Standard Error|Least Squares Mean
2719287|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population|||participants|||Number
2719290|NCT01105091|Primary|Heart Rate - Baseline and Day 28|Heart rate was measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Heart Rate was assessed at Baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||Beats per minute||Full Range|Median
2719291|NCT01105091|Primary|Blood Pressure - Baseline and Day 28|Blood pressure (systolic and diastolic) were measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Blood Pressure was assessed at baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||mm Hg||Full Range|Median
2719292|NCT01105091|Primary|Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28|Central venous blood oxygen saturation assessment was performed only in specific centers. Measurements for ScVO2 were performed during the inpatient hospitalization period on Day 1 (prior to drug initiation) and on Day 28 (EOT). Samples for ScVO2 were obtained by aspirating blood from the indwelling central venous catheter. After the sample had been drawn, the catheter was primed with study drug in order to refill the lumen to avoid interruption in treatment and sudden decompensation.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||percentage oxygen saturation||Full Range|Median
2719293|NCT01105091|Primary|Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|From baseline to 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||participants|||Number
2719294|NCT01105091|Primary|Six-minute Walk Distance (6MWD) - Baseline and Day 28|The 6-minute walk test (6MWT) was to be performed prior to initiating study treatment either during the screening visit or on Day 1 prior to drug initiation, and Day 28 (End of treatment (EOT)). This assessment is a non-encouraged test that measures the distance walked for a duration of 6 minutes. The 6MWD was recorded in the Case Report Form (CRF).|Baseline and 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||meters||Full Range|Median
2719295|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
2719296|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
2719297|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
2719298|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
2719299|NCT01105065|Secondary|Frequency Doubling Perimetry|Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant.|8 weeks||||dB||Standard Deviation|Mean
2719300|NCT01105065|Primary|Presence of Retinal Blood Flow Autoregulation|We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.|8 weeks||||participants|||Number
2719301|NCT01104870|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 12|The N-terminal pro-BNP (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 12.|Baseline and Week 12|All subjects with Baseline and Week 12 NT-proBNP values recorded were included in the analysis.|||pg/mL||Standard Deviation|Mean
2721690|NCT01085045|Secondary|Change in Morning Pre-dose FEV1 on Day 7|Change from Baseline in morning pre-dose FEV1 on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2719302|NCT01104870|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 12|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. Only participants who experienced a change in WHO functional classification from Baseline to Week 12 are described by class change below; all other participants maintained their Baseline WHO functional classification at Week 12.|Change from Baseline at Week 12|All subjects with Baseline and Week 12 WHO functional classifications recorded were included in the analysis.|||participants|||Number
2719303|NCT01104870|Secondary|Change in PH Symptoms From Baseline to Week 12|Symptoms of PH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed and severity grade values (i.e., 0, 1, 2 or 3) for each symptom were assigned for subjects. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Median change in symptom severity from Baseline to Week 12 is described.|Change from Baseline at 12 Weeks|All subjects with Baseline and Week 12 values recorded for symptoms of PH were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2719304|NCT01104870|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 12|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and Week 12|All subjects with Baseline and Week 12 Borg dyspnea scores recorded were included in the analysis.|||score||Inter-Quartile Range|Median
2719305|NCT01104870|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Week 12|The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). Subjects were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and Week 12|All subjects with Baseline and Week 12 6MWD values recorded were included in the analysis.|||meters||Standard Deviation|Mean
2719306|NCT01104870|Secondary|Change in Cardiac Index (CI) From Baseline to Week 12|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 CI values recorded were included in the analysis.|||L/min/m^2||Standard Deviation|Mean
2719307|NCT01104870|Secondary|Change in Mean Pulmonary Artery Pressure (PAPm) From Baseline to Week 12|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. The PAPm values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 PAPm values recorded were included in the analysis.|||mmHg||Standard Deviation|Mean
2719308|NCT01104870|Primary|Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12|"The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups.~The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject's morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmonary Resistance Index (TPRI) (mmHg/[L/min/m^2]) is Mean Pulmonary Artery Pressure (PAPm)/ Cardiac Index (CI)."|Baseline and Week 12|All subjects with Baseline and Week 12 TPRI values recorded were included in the analysis.|||mmHg/(L/min/m^2)||Standard Deviation|Mean
2719309|NCT01104792|Secondary|Change From Baseline to Week 48 in the CGI-S Score|The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.|Baseline to Week 48|Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2719310|NCT01104792|Primary|Change From Baseline to Week 48 in the PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 48|Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline efficacy assessment. Only participants with data at both Baseline and Week 48 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2719486|NCT01103778|Primary|Number of Participants With Complete Remission, Partial Response, or no Response.|"Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection.~Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection."|1 year|1 participant was lost to followup.|||Participants|||Count of Participants
2719311|NCT01104779|Secondary|Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)|"The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a normal state and 7 indicating among the most extremely ill participants. A higher score indicates greater illness. A negative change score indicates improvement."|Baseline to Week 6|Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.|||units on a scale||Standard Error|Least Squares Mean
2719312|NCT01104779|Primary|Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.|Baseline to Week 6|Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.|||Units on a Scale||Standard Error|Least Squares Mean
2719313|NCT01104766|Secondary|Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)|"The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a normal state and 7 indicating among the most extremely ill participants. A higher score indicates greater illness. A negative change from baseline score indicates improvement."|Baseline to Week 6|Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.|||Units on a Scale||Standard Error|Least Squares Mean
2719314|NCT01104766|Primary|Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.|The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.|Baseline to Week 6|Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.|||Units on a Scale||Standard Error|Least Squares Mean
2719315|NCT01104701|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance (PCI): triacylglycerol lipase high values were > 3* upper limit of normal (ULN); creatinine high values in males >1.6 mg/dL, females >1.4 mg/dL; gamma glutamyl transferase (GGT) high value >3* ULN; bilirubin high value > 2 mg/dL; Urate high values > 10 (males), >8 (females) mg/dL; potassium low value < 3 milliequivalents per liter (mEq/L), high value >5.5 mEq/L; calcium low value < 8 mg/dL and high value > 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented.|Day 1 to Study Termination (Week24) or early termination|All participants who were randomized and received at least one dose of study drug were analyzed in the intent to treat (ITT) population. n= all participants who received at least one dose of study drug and had available laboratory measurements.|||laboratory values|||Number
2719316|NCT01104701|Secondary|Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance are the following: Hematocrit values for males less than (<) 36%, females < 30%; hemoglobin for males <12 grams per deciliter (g/dL), females < 10 g/dL; low platelet values <75,000/micro liter (µL), high values greater than (>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination.|Day 1 to study termination (24 weeks) or early termination|n= all participants who received at least one dose of study drug and had available laboratory measurements.|||laboratory values|||Number
2719317|NCT01104701|Secondary|Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1.|Day 1 to Study Termination (24 weeks) or early termination|n=all participants who received at least one dose of study drug and had available titer.|||participants|||Number
2719338|NCT01104584|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
2719318|NCT01104701|Secondary|Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population|"AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth.~Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19.~."|Day 1 through study termination (Week 24) or early termination.|All participants who received at least one dose of study drug were analyzed in the ITT population.|||participants|||Number
2719319|NCT01104701|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination.|Day 1 to Study Termination (24 Weeks) or early Termination|All participants who received at least one dose of study drug were included in the ITT analysis.|||participants|||Number
2719320|NCT01104701|Secondary|Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the ITT population.|||bpm||Standard Deviation|Mean
2719321|NCT01104701|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the Intent to Treat (ITT) population.|||mmHg||Standard Deviation|Mean
2719322|NCT01104701|Secondary|Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population|All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL).|Day 1 to Week 20|PK Evaluable- Steady-State: from trough to trough following Week 12 through Week 16, 3 or more values.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2719323|NCT01104701|Secondary|Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population|Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.|||mg/dL||Standard Error|Mean
2719324|NCT01104701|Secondary|Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population|Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis. n=number of participants with measurement value.|||kg||Standard Error|Mean
2719325|NCT01104701|Secondary|Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population|HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were <7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value for Week 20 were included in the analysis of the evaluable population. n=number of participants with measurement value.|||percentage of Participants|||Number
2719326|NCT01104701|Primary|Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population|HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to 20 weeks|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.|||Percent of Hemoglobin||Standard Error|Mean
2719327|NCT01104662|Secondary|Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit|"Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:~Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.~Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.~Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator."|Baseline through TOC/Safety Visit|Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.|||participants|||Number
2719328|NCT01104662|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)|The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.|Baseline through EOT/ET|Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.|||participants|||Number
2719329|NCT01104636|Secondary|Level of Nicotine Dependence Measured by the Fagerstrom Test|Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence).|Baseline|The all participants’ population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.|||Scores on a scale||Standard Deviation|Median
2719330|NCT01104636|Primary|Percentage of Participants Who Abstained From Smoking at Week 12|The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.|Week 12|The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.|||percentage of participants||95% Confidence Interval|Number
2719331|NCT01104584|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow-up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow-up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||Participants|||Number
2719332|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow-up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow-up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||beats/min||Standard Deviation|Mean
2719333|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow-up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, 24 hours post injection|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||mmHg||Standard Deviation|Mean
2719334|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."||||||
2719335|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."||||||
2719336|NCT01104584|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||Kappa|Participants||Number
2719337|NCT01104584|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
2719487|NCT01103778|Primary|Proteinuria|Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.|Baseline and 1 year|1 participant was lost to followup.|||grams per 24 hrs||Full Range|Median
2719339|NCT01104584|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Sensitivity Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||Kappa|Participants||Number
2719340|NCT01104584|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Clinical Investigator, Participant Level|"The disease state bilateral malignant disease was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region , the assessment of bilateral malignant disease was categorized as No. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as Yes. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease were derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively."|Immediately before injection and after injection|The analyses were based on 380 participants in FAS; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.|||difference in accuracy (%)||95% Confidence Interval|Mean
2719341|NCT01104584|Other Pre-specified|Sensitivity of Detection of Multicentric Malignant Disease Verified by SoT, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2719342|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
2719343|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
2719344|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
2719345|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2719346|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2719365|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719347|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions. Difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2719348|NCT01104584|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N-FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 395 participants in FAS; evaluable for specificity were breasts with or without malignant disease verified by SoT with available assessments by the imaging modality.|||specificity (%)||95% Confidence Interval|Mean
2719349|NCT01104584|Other Pre-specified|Breast Level Specificity in Malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
2719350|NCT01104584|Other Pre-specified|Breast Level Specificity of in Non-malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants; evaluable for specificity were breasts with no malignant disease verified by SoT for which an assessment of the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
2719351|NCT01104584|Other Pre-specified|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using XRM, CMRM+XRM and UMRM+XRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were performed for a total number of 390 participants who had regions with malignant disease verified by SoT with available assessment by the imaging modality.|||sensitivity (%)||95% Confidence Interval|Mean
2719352|NCT01104584|Secondary|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Reader, Participant Level|The investigator and the blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1 = not confident, 2 = somewhat confident, 3 = confident, and 4 = very confident). For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference of scores on a scale||95% Confidence Interval|Mean
2719353|NCT01104584|Secondary|Percentage Difference of Participants Whose Additional Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The evaluation was based on the 84 participants in the FAS who had at least one additional cancer region according to SoT.|||difference in percentage of participants||95% Confidence Interval|Number
2719354|NCT01104584|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.|||difference in percentage of participants||95% Confidence Interval|Number
2719355|NCT01104584|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
2719390|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
2719356|NCT01104584|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SoT) for which a CMRM assessment was available.|||specificity (%)||95% Confidence Interval|Mean
2719357|NCT01104584|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).|||sensitivity (%)||95% Confidence Interval|Mean
2719358|NCT01104584|Primary|Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).|||difference in sensitivity (%)||95% Confidence Interval|Mean
2719359|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||pg/mL||Standard Deviation|Mean
2719360|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||pg/mL||Standard Deviation|Mean
2719361|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||pg/mL||Standard Deviation|Mean
2719362|NCT01104558|Secondary|Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||picograms (pg)/ milliliter (mL)||Standard Deviation|Mean
2719363|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719364|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719366|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719367|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719368|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719369|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719370|NCT01104558|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719371|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719372|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719373|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719374|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719375|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719376|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719377|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
2719525|NCT01103414|Secondary|Presence of Edema Post Baseline During 12 Weeks Active Treatment|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both a baseline and post baseline edema assessment|||participants|||Number
2719378|NCT01104558|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2719379|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719380|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719381|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719382|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719383|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719384|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719385|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
2719386|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Beats per minute (bpm)||Standard Deviation|Mean
2719387|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
2719388|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
2719389|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
2719391|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
2719392|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
2719393|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
2719394|NCT01104558|Secondary|Duration of Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Participant analyzed included 1 participant from the efficacy ITT population who was hospitalized once due to heart failure.|||Days|||Number
2719395|NCT01104558|Secondary|Number of Participants With Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration.|||Participants|||Number
2719396|NCT01104558|Primary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)||Baseline and Week 26 (or EOT)|"Efficacy intention to treat (ITT) population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
2719397|NCT01104545|Secondary|Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants|Platelet aggregation induced by adenosine diphosphate (ADP) was measured at predose (baseline) and 3 and 24 hours postdose. Percent inhibition from baseline at 24 hours postdose was calculated. Due to change in number of blood draws and total blood volume restrictions, data for platelet aggregation were only collected for first 2 periods of each panel. Therefore only limited data were available and summarized.|Baseline and 24 hours postdose for each dose level|All participants in Panel C who received at least 1 dose of study drug and had available data for endpoint.|||Percentage change||Standard Deviation|Mean
2719398|NCT01104545|Secondary|Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants|Platelet aggregation induced by adenosine diphosphate (ADP) was measured at predose (baseline) and 3 and 24 hours postdose. Percent inhibition from baseline at 24 hours postdose was calculated. Due to change in number of blood draws and total blood volume restrictions, data for platelet aggregation were only collected for first 2 periods of each panel. Therefore only limited data were available and summarized. Data for each specific dose were combined regardless of panel.|Baseline and 24 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||Percentage change||Standard Deviation|Mean
2719399|NCT01104545|Secondary|Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants|Blood was drawn at predose (baseline) and 1, 4, 8, and 24 hours postdose. The change in cyclic GMP at 24 hours postdose was summarized. Due to change in number of blood draws and total blood volume restrictions, data for GMP were only collected for first 2 periods of each panel. Therefore only limited data were available and summarized.|Baseline and 24 hours postdose for each dose level|All participants in Panel C who received at least 1 dose of study drug and had available data for endpoint.|||Percentage change||Standard Deviation|Mean
2719400|NCT01104545|Secondary|Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants|Blood was drawn at predose (baseline) and 1, 4, 8, and 24 hours postdose. The change in cyclic GMP at 24 hours postdose was summarized. Due to change in number of blood draws and total blood volume restrictions, data for GMP were only collected for first 2 periods of each panel. Therefore only limited data were available and summarized. Data for each specific dose were combined regardless of panel.|Baseline and 24 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||Percentage change||Standard Deviation|Mean
2719401|NCT01104545|Secondary|Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants|Blood was to be drawn at predose (baseline) and 3 and 24 hours postdose and bleeding time was to be assessed using a Newborn Surgicutt device. Change in bleeding time from baseline at 24 hours postdose were to be summarized. Due to change in number of blood draws and total blood volume restrictions, bleeding time assessment was not performed as planned.|Baseline and 24 hours postdose for each dose level|All participants in Panel C who received at least 1 dose of study drug and had available data for endpoint.||||||
2719402|NCT01104545|Secondary|Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants|Blood was to be drawn at predose (baseline) and 3 and 24 hours postdose and bleeding time was to be assessed using a Newborn Surgicutt device. Change in bleeding time from baseline at 24 hours postdose were to be summarized. Due to change in number of blood draws and total blood volume restrictions, bleeding time assessment was not performed as planned.|Baseline and 24 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.||||||
2719403|NCT01104545|Secondary|Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants|Augmentation index was measured at predose (baseline), and 1, 4, 8, 12, and 24 hours postdose by aplanation tonometry of radial artery. The change from baseline at 24 hours postdose was summarized.|Baseline and 24 hours postdose for each dose level|All participants in Panel C who received at least 1 dose of study drug and had available data for endpoint.|||Percentage change||Standard Deviation|Mean
2719404|NCT01104545|Secondary|Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Healthy Participants|Augmentation index was measured at predose (baseline), and 1, 4, 8, 12, and 24 hours postdose by aplanation tonometry of radial artery. The change from baseline at 24 hours postdose was summarized. Data for each specific dose were combined regardless of panel.|Baseline and 24 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||Percentage change||Standard Deviation|Mean
2719405|NCT01104545|Secondary|Maximum Concentration (Cmax) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of 0.25 mg MK-3614 when administered after an 8 hour fast and after a high-fat breakfest.|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in Panel A who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||nM||Standard Deviation|Mean
2719406|NCT01104545|Secondary|Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of 0.25 mg MK-3614 in healthy participant when administered after an 8 hour fast and after a high-fat breakfest.|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in Panels A who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||nM•h||Standard Deviation|Mean
2719407|NCT01104545|Primary|Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants|Brachial arterial diastolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device. The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized. Data for each specific dose were combined regardless of sequnce.|Baseline and 24 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||mmHg||Standard Deviation|Mean
2719408|NCT01104545|Primary|Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants|Brachial arterial systolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device. The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized. Data for each specific dose were combined regardless of sequence.|Baseline and 24 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||mmHg||Standard Deviation|Mean
2719409|NCT01104545|Primary|Change From Baseline in Heart Rate - Hypertensive Participants|HR measurements were obtained using a validated, semi-automated oscillometric device. The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized. Data for each specific dose were combined regardless of sequence.|Baseline and 24 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||bpm||Standard Deviation|Mean
2719410|NCT01104545|Primary|Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants|Brachial arterial diastolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device. The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized. Data for each specific dose were combined regardless of panel.|Baseline and 24 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||mmHg||Standard Deviation|Mean
2719411|NCT01104545|Primary|Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants|Brachial arterial systolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device. The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized. Data for each specific dose were combined regardless of panel.|Baseline and 24 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||mmHg||Standard Deviation|Mean
2719412|NCT01104545|Primary|Change From Baseline in Heart Rate - Healthy Participants|Heart rate measurements were obtained using a validated, semi-automated oscillometric device. The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized. Data for each specific dose were combined regardless of panel.|Baseline and 24 hours post-dose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||Beats per minute (bpm)||Standard Deviation|Mean
2719413|NCT01104545|Primary|Apparent Terminal Half-life (t1/2) of MK-3614 of MK-3614- Hypertensive Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the t1/2 of MK-3614 in hypertensive participants|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint. Data were summarized by dose taken and not by sequence.|||hr||Standard Deviation|Mean
2719414|NCT01104545|Primary|Time to Cmax (Tmax) of MK-3614- Hypertensive Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Tmax of MK-3614 in hypertensive participants|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint. Data were summarized by dose taken and not by sequence.|||hr||Full Range|Median
2719415|NCT01104545|Primary|Maximum Concentration (Cmax) of MK-3614- Hypertensive Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of MK-3614 in hypertensive participants|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint. Data were summarized by dose taken and not by sequence.|||nM||Standard Deviation|Mean
2719416|NCT01104545|Primary|Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Hypertensive Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of MK-3614 in hypertensive participants|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in in Panel C who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint. Data were summarized by dose taken and not by sequence.|||nM•h||Standard Deviation|Mean
2719417|NCT01104545|Primary|Apparent Terminal Half-life (t1/2) of MK-3614- Healthy Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the t1/2 of MK-3614 in healthy participants.|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||hr||Standard Deviation|Mean
2719418|NCT01104545|Primary|Time to Cmax (Tmax) of MK-3614- Healthy Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Tmax of MK-3614 in healthy participants.|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||hour (hr)||Full Range|Median
2719419|NCT01104545|Primary|Maximum Concentration (Cmax) of MK-3614- Healthy Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of MK-3614 in healthy participants.|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||nM||Standard Deviation|Mean
2719420|NCT01104545|Primary|Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Healthy Participants|Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of MK-3614 in healthy participants.|Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and had available data for the endpoint.|||nM•h||Standard Deviation|Mean
2719421|NCT01104545|Primary|Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who were discontinued from the study due to an AE were summarized. AEs are reported by the dose taken at the time of the event.|up to 7 days for each dose level|All participants in in Panel C who received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2719422|NCT01104545|Primary|Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. The percentage of participants that reported at least 1 AE was summarized. AEs are reported by the dose taken at the time of the event.|up to 7 days for each dose level|All participants in in Panel C who received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2719423|NCT01104545|Primary|Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who were discontinued from the study due to an AE were summarized. AEs are reported by the dose taken at the time of the event.|up to 7 days for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2719424|NCT01104545|Primary|Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. AEs are reported by the dose taken at the time of the event.|up to 7 days for each dose level|All participants in Panels A and B who received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2719425|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-181|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719426|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-29|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719427|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719428|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom.|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719429|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719430|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719431|NCT01104493|Primary|Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
2719432|NCT01104415|Secondary|Change From Baseline in Urinary 5-Hydroxyindoleacetic Acid (HIAA) Levels|Urinary 5-HIAA (u5-HIAA) is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. The change from baseline value for the Extension Period was calculated as the difference between mean change in 5-HIAA of the post-baseline interval (Weeks 20 to 21) and baseline. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.|Core Phase: Baseline to Week 12; Extension Period: Baseline to Weeks 20-21|Pharmacodynamic (PD) analysis set included all participants who had received at least 1 dose of study drug, had a valid baseline PD assessment, and at least 1 valid post-baseline PD assessment (whole blood 5-HT or u5-HIAA) in Core Phase and Extension Period.|||mg/24 hours||Standard Deviation|Mean
2719433|NCT01104415|Secondary|Number of Participants Achieving Clinically Meaningful Symptom Reduction in the Core Phase|Clinically meaningful symptom reduction was defined as either: a) an average of < 4 bowel movements per day over 15 consecutive days, b) a 50% reduction from baseline in the number of bowel movements, c) a positive response to the question regarding adequate relief, or d) a 50% reduction from baseline in the number of daily flushing episodes.|Baseline to Week 12|EFAS included all participants who had at least 1 post-baseline efficacy assessment.|||Participants|||Count of Participants
2719441|NCT01104415|Primary|Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.|Up to 124 Weeks in the Extension Period|SS included all enrolled participants who had received at least 1 dose of study drug in the 124-week Extension Period.|||Participants|||Count of Participants
2719434|NCT01104415|Secondary|Change From Baseline in Daily Number of Cutaneous Flushing Episodes|Participants recorded the number of daily cutaneous flushing episodes experienced in the daily diary. The change from baseline value was calculated as the difference between the mean numbers of cutaneous flushing episodes of the post-baseline interval (Weeks 9 to 12) and baseline. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.|Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24|EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.|||Daily number of flushing episodes||Standard Deviation|Mean
2719435|NCT01104415|Secondary|Change From Baseline in Daily Severity of Abdominal Pain or Discomfort Using 100 mm Visual Analog Scale (VAS)|The severity of abdominal pain was measured using a 100 mm VAS. Participants rated their perception of the sensation/severity of abdominal pain or experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No vomiting and 100 = vomiting. The change from the baseline value was calculated as the difference between the mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicate the best score, 100 indicates the worst score. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.|Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24|EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2719436|NCT01104415|Secondary|Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome|"Participants assessed their symptoms using a weekly subjective response to the following question, In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?. The values for improvement in global assessment of symptoms associated with carcinoid syndrome in the Core Phase were averaged from Weeks 9 to 12."|Core Phase: Weeks 9-12; Extension Period: Week 24|EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2719437|NCT01104415|Secondary|Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS)|Sensation/severity of nausea was measured using a 100 mm VAS. Participants rated their perception of the sensation/severity of nausea experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No vomiting and 100 = vomiting. The change from the baseline value was calculated as the difference between the mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicates the best score, 100 indicates the worst score. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.|Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24|EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2719438|NCT01104415|Secondary|Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate|"Participants assessed the urgency to defecate using a daily diary response to the following question, Have you felt or experienced a sense of urgency to pass stool today?. The change from the baseline value was calculated as the difference between the mean score (percentage of days) of the post-baseline interval (Weeks 9 to 12) and baseline. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug."|Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24|EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of days||Standard Deviation|Mean
2719439|NCT01104415|Secondary|Change From Baseline in Stool Form/Consistency|Participants assessed stool form/consistency in a daily diary using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery). The change from the baseline value was calculated as the difference between a mean score of the post-baseline interval (Weeks 9 to 12) and baseline. 0 indicates the best score and 5 indicates the worst score. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.|Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24|EFAS in the Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in the Extension period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in 124-week Extension Period. Number analyzed is the number of participants with evaluable data at given time-point.|||score on a scale||Standard Deviation|Mean
2719440|NCT01104415|Secondary|Change From Baseline in Number of Bowel Movements (BMs)|Participants recorded the number of bowel movements in a daily diary. The change from baseline value was calculated as the difference between mean numbers of BMs of the post-baseline interval (Weeks 9 to 12) and baseline. A negative change from baseline indicates improvement. Baseline for the Extension Period was defined as non-missing assessment in Run-in period prior to the first dose of study drug.|Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24|Efficacy full analysis set (EFAS) in Core Phase included all participants with at least 1 post-Baseline efficacy assessment and full analysis set (FAS) in Extension Period(EP) included all participants in SS with at least 1 post-Baseline efficacy assessment in 124-week EP. Number analyzed is the participants with evaluable data at given time point.|||number of bowel movements/day||Standard Deviation|Mean
2721544|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2719442|NCT01104415|Primary|Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.|Baseline up to Week 12 in the Core Phase|The safety set (SS) included all the enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2719443|NCT01104402|Secondary|Serious Adverse Events (SAE)|Adverse event rates will be coded by body system and MedDRA classification term. Adverse events will be tabulated by treatment group and will include the number of subjects for whom the event occurred, the rate of occurrence, and the severity and relationship to study participation or study procedures.|12 months||||proportion of participants with SAEs|||Number
2719444|NCT01104402|Secondary|Change in Prevalence of Resistant Species of Bacteria|Change in prevalence of resistant species of bacteria (Methicillin Resistant S. aureus, Pseudomonas aeruginosa, Burkolderia cepacia, Stenotrophomona maltophilia, Achromobacterxylosoxidans) in sputum between baseline and final visit (Visit 5 or early withdrawal) will be summarized by treatment group.|12 months||||percentage of subjects with new MRPA|||Number
2719445|NCT01104402|Secondary|Treatment Burden|Change in treatment burden as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. Scores range from 0-100 with higher scores indicating less treatment burden.|Change from baseline to 12 months||||units on a scale||Standard Deviation|Mean
2719446|NCT01104402|Secondary|Change in Health Related Quality of Life Scores as Assessed by the Cystic Fibrosis Questionnaire Revised (CFQ-R) (Respiratory Subscale Only(|Change in health related quality of life as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The CFQ-R measures functioning in a variety of domains, including Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning, and Social Functioning. Only the respiratory subscale of the the CFQ-R was evaluated. This ranges from 0 to 100 with higher scores indicating better respiratory quality of life. A negative number indicates a decrease in respiratory quality of life.|Change from baseline to 12 months||||units on a scale||Standard Deviation|Mean
2719447|NCT01104402|Secondary|Pulmonary Exacerbations|Percentage of participants who experienced at least one acute pulmonary exacerbation|12 months||||percentage of participants|||Number
2719448|NCT01104402|Secondary|Cystic Fibrosis Respiratory Symptom Diary (CFRSD)|Change in CF respiratory symptoms as measured by the CFRSD. The CFRSD consists of 8 items which quantify symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recovery from an exacerbation. The CFRSD also includes emotional and activity impacts. Emotional impacts include frustration, sadness/depression, irritability, worry, and difficulty sleeping. Activity impacts include time spent sitting or lying down, reduction of usual activities, and missing school or work. will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The range of scores is 8 to 40 with higher scores indicating more severe symptoms.|12 months||||units on a scale||Standard Deviation|Mean
2719449|NCT01104402|Primary|Change in FEV1|The primary outcome variable is FEV1 which will be obtained at quarterly study visits. The primary analysis will use a linear mixed effects model incorporating all FEV1 measurements to estimate the 52-week change in FEV1|12 months||||Liters||95% Confidence Interval|Mean
2719450|NCT01104376|Primary|Measure Efavirenz Clearance|Effect of steady-state voriconazole on efavirenz Clearance in healthy volunteers (n=61) administered a single 100 mg oral dose of efavirenz at baseline (control phase) and after treatment with voriconazole to steady-state.|Baseline, 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after efavirenz||||ml/min/kg||Standard Deviation|Mean
2719451|NCT01104311|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events|24 Weeks|The number of participants are analyzed by Safety population.|||participants|||Number
2719452|NCT01104311|Secondary|Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.||24 Weeks|The number of participants are analyzed by ITT population.|||participants|||Number
2719453|NCT01104311|Secondary|Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.||24 Week|The number of participants are analyzed by ITT population.|||events|||Number
2719454|NCT01104311|Secondary|Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.||24 weeks|The number of participants are analyzed by ITT Population.|||participants|||Number
2719455|NCT01104311|Secondary|The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI||24 weeks|The Number of Participants are analyzed by ITT (Intent to treat) Population. ITT Population (Aggressive BP Lowering: 66, Modest BP Lowering: 63)|||participants|||Number
2719456|NCT01104311|Secondary|Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population|the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI|24 weeks|The number of participants are analyzed by FAS population.|||cc||Standard Deviation|Mean
2719457|NCT01104311|Primary|Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)|The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI|Screening to 24 weeks|The Number of Participants Analyzed by FAS(Full analysis)Population. FAS Population (Aggressive BP Lowering: 59, Modest BP Lowering: 52)|||cc||Standard Deviation|Mean
2719458|NCT01104285|Primary|Total Days of Mechanical Ventilatory Support||days||||days||Standard Deviation|Mean
2719484|NCT01103778|Secondary|Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.|Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.|1 year||||Participants|||Count of Participants
2719459|NCT01104246|Primary|Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours|A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.|Day 28/29|Per-protocol Population was used for the analysis. PP population included subjects who completed the treatment period of the study, who did not have more than two consecutive missing data, and who did not have any major protocol deviations.|||ng/dL||Standard Deviation|Mean
2719460|NCT01104207|Primary|Change in Tinnitus Functional Index (TFI) Score|The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.|26 weeks post-treatment||||units on TFI scale; change from baseline||Standard Deviation|Mean
2719461|NCT01104155|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS|||Months||95% Confidence Interval|Median
2719462|NCT01104155|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS|||Percentage of participants||95% Confidence Interval|Number
2719463|NCT01104155|Secondary|Progression-Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years|FAS|||Months||95% Confidence Interval|Median
2719464|NCT01104155|Secondary|Duration of Response (DOR)|DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.|From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years|FAS|||Months||95% Confidence Interval|Median
2719465|NCT01104155|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)|From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)|Full analysis set (FAS) (Intent-to-treat population) included all participants who took at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2719466|NCT01104116|Secondary|Change in Lesion Characteristics to Assess Benefit of PET Scans|The secondary outcome that we are interested in studying is the benefit of PET scan as compared to other imaging modalities, such as CT, MRI, and EUS. Thus, Patients will also have CT, MRI, and EUS imaging. We will look at how size, location, and branch of the IPMN lesion on PET compare to these other imaging modalities. The location, size, and pathology results of the actual surgical specimen will serve as the gold standard.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.||||||
2719467|NCT01104116|Primary|Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN|The primary outcome will be to determine the positive and negative predictive values of [18F]-FDG PET imaging for identifying malignant IPMN lesions in patients who are to undergo surgical resection. We will determine the mean SUV that would provide optimal positive predictive value for malignant IPMN. IPMN lesions will be classified categorically as benign (adenoma or borderline ) or malignant (in situ or invasive carcinoma) and PET imaging will be classified categorically as negative or positive, with focal FDG uptake corresponding to pancreatic lesion.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.||||||
2719468|NCT01104103|Secondary|First Stick Success|This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.|Five minutes (average)||||participants|||Number
2719469|NCT01104103|Primary|Success|This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.|five minutes (average)||||participants|||Number
2719470|NCT01103973|Secondary|Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)|Psychological status is assessed by the Beck Depression Inventory (BDI). The scores range from 0 to 63; a score of 0 being no depression and 63 being severely depressed. Our cut-off for normal was a score of 12 or less, and those with a score of 13 or greater were considered to have symptoms of depression.|1 year|Subjects were evaluated before IVF cycle 1 and cycle 2 if applicable. The N varies per cycle as some patients withdrew from the study or did not have a second cycle.|||Participants|||Count of Participants
2719471|NCT01103973|Primary|Clinical Pregnancy Rates|Presence of normal fetal heart rate and fetal size at 7 weeks gestation.|1 year||||percentage of participants|||Number
2719472|NCT01103960|Secondary|Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.|Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From drug administration until end of treatment plus one day|Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.|||participants|||Number
2719473|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories at 4 Weeks|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|4 weeks|FAS with LOCF|||Number of participants|||Number
2719474|NCT01103960|Secondary|DBP and SBP Control and Response After 4 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 4 weeks|FAS with LOCF|||Number of participants|||Number
2719475|NCT01103960|Secondary|Change From Baseline in SBP After 4 Weeks of Treatment|Seated trough SBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF|||mmHg||Standard Deviation|Mean
2719476|NCT01103960|Secondary|Change From Baseline in DBP After 4 Weeks of Treatment|Seated trough DBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF|||mmHg||Standard Deviation|Mean
2719477|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|8 weeks|FAS with LOCF|||Number of participants|||Number
2719478|NCT01103960|Secondary|DBP and SBP Control and Response After 8 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 8 weeks|FAS with LOCF|||Number of participants|||Number
2719479|NCT01103960|Secondary|Change From Baseline in SBP After 8 Weeks of Treatment|Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF|||mmHg||Standard Error|Least Squares Mean
2719480|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients|Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF and further restricted to the Chinese subgroup|||mmHg||Standard Error|Least Squares Mean
2719481|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment|Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.|||mmHg||Standard Error|Least Squares Mean
2719482|NCT01103934|Secondary|Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.|Baseline and 2 weeks||||units on a scale||Full Range|Median
2719483|NCT01103934|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.|Baseline and 2 weeks||||units on a scale||Full Range|Median
2719488|NCT01103713|Other Pre-specified|Summary of Plasma Desethylchloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.|||ng/ml||Standard Deviation|Mean
2719489|NCT01103713|Other Pre-specified|Summary of Plasma Chloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.|||ng/ml||Standard Deviation|Mean
2719490|NCT01103713|Other Pre-specified|Summary of Serum Azithromycin Concentration Versus Time|AZ concentrations in the serum was determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming hour not specified as 0 hours on Day 7 and Day 14 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.|||ng/ml||Standard Deviation|Mean
2719491|NCT01103713|Other Pre-specified|Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level|Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value <0.8 times lower limit of normal was considered clinically significant.|Day 42|The safety analysis set consists of participants who received at least one dose of study medication.|||Participants|||Number
2719492|NCT01103713|Other Pre-specified|Incidence of Fever Based on Oral Temperature|Oral temp was taken by the fieldworker through Day 42.|Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42|ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Participants|||Number
2719493|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Outcome of Birth|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.|||Participants|||Number
2719494|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Complications During Delivery?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.|||Participants|||Number
2719495|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Labor Induced?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only.|||Participants|||Number
2719496|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.|||Participants|||Number
2719497|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Mode of Delivery|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.|||Participants|||Number
2719498|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Location of Delivery|All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.|||Participants|||Number
2719499|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Parasite count per microliter||Standard Error|Mean
2719500|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Parasite count per microliter||Standard Error|Mean
2719501|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Parasite count per microliter||Standard Error|Mean
2719502|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719503|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719504|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719505|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719506|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719507|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719508|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719509|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
2719510|NCT01103505|Secondary|Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV|Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.|2 years|51 of 763 patients progressed to CNV in the device arm and 30 of 757 patients progressed to CNV in the standard care alone arm. Patients that progressed to CNV were analyzed in this secondary analysis.|||Disc Areas||Inter-Quartile Range|Median
2719511|NCT01103505|Secondary|Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV|Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.|2 years|Of 51 patients who progressed to CNV in the device arm, 39 had an FA performed, and of 30 patients who progressed to CNV in the standard care alone arm, 23 had an FA performed. Patients that progressed to CNV and had FAs performed were analyzed in this secondary analysis.|||Disc Areas||Inter-Quartile Range|Median
2719512|NCT01103505|Secondary|Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV|Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm^2.|2 years|Of 51 patients who progressed to CNV in the device arm, 39 had an FA performed, and of 30 patients who progressed to CNV in the standard care alone arm, 23 had an FA performed. Patients that progressed to CNV and had FAs performed were analyzed in this secondary analysis.|||Disc Areas||Inter-Quartile Range|Median
2719513|NCT01103505|Secondary|Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection|Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm|2 years|51 of 763 patients progressed to CNV in the device arm and 30 of 757 patients progressed to CNV in the standard care alone arm. Patients that progressed to CNV were analyzed in this secondary analysis.|||percentage of patients|||Number
2719514|NCT01103505|Primary|Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization|Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.|2 years|Patients in each study arm that progressed from intermediate AMD to CNV during the study were evaluated according to the primary and secondary endpoints. 51 of 763 patients in the device + standard care arm progressed to CNV during the trial, and 30 of 757 patients in the standard care alone arm progressed to CNV during the trial.|||LogMAR letters (ETDRS)||Standard Deviation|Mean
2719515|NCT01103492|Primary|Number of Participants With Adverse Events|As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.|1 year|There was no analysis of the data. Feasibility study with only one subject enrolled|||partipants|||Number
2719516|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study||||participants|||Number
2719517|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study||||participants|||Number
2719518|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via FOBT, FIT or Colonoscopy|within 6 months of provider recommendation||||participants|||Number
2719519|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy|within 6 months of provider recommendation||||participants|||Number
2719520|NCT01103466|Primary|Leakage Under the Base Plate|"Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is no leakage and 24 is complete leakage under the base plate."|At every change of base plate|ITT|||units on a scale||Standard Deviation|Mean
2719521|NCT01103440|Secondary|Number of Participants With Major Adverse Cardiac Event (MACE)|Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product.|30 days||||Participants|||Count of Participants
2719522|NCT01103440|Primary|Number of Participants With Elevation of Cardiac Enzyme|Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure.|24 hours||||Participants|||Count of Participants
2719523|NCT01103414|Secondary|Changes in LDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 week|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.|||nM||Standard Deviation|Mean
2719524|NCT01103414|Secondary|Changes in HDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 weeks|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.|||nM||Standard Deviation|Mean
2719526|NCT01103414|Secondary|Change From Baseline in Waist Circumference at Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both baseline and week 12 waist circumference assessments|||cm||Standard Deviation|Mean
2719527|NCT01103414|Secondary|Change in Body Weight From Baseline to Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||kg||Standard Deviation|Least Squares Mean
2719528|NCT01103414|Secondary|Change From Baseline in RBC|Change from baseline at week 12 endpoint in red blood cell concentration|12 week|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments|||10e-6 cells per uL||Standard Deviation|Mean
2719529|NCT01103414|Secondary|Change From Baseline in Hemoglobin|Change from baseline at week 12 endpoint in hemoglobin concentration|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments.|||g/dL||Standard Deviation|Mean
2719530|NCT01103414|Secondary|Change From Baseline to Week 12 Endpoint in Hematocrit|Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||percentage of volume||Standard Error|Least Squares Mean
2719531|NCT01103414|Secondary|Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin|Percent change from baseline to week 12 endpoint in high molecular weight adiponectin|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||percentage of baseline values||Standard Deviation|Least Squares Mean
2719532|NCT01103414|Secondary|Change From Baseline in HbA1c|Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||percentage of hemoglobin||Standard Deviation|Least Squares Mean
2719533|NCT01103414|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.|Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|Baseline, Week 12|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||mg/dL||Standard Error|Least Squares Mean
2719534|NCT01103362|Primary|The Frequency of Adverse Events||A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD||||percentage of patients-any adverse event|||Number
2719535|NCT01103323|Secondary|Tumor Response|A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Percentage of participants|||Number
2719536|NCT01103323|Secondary|Disease Control|Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Percentage of participants|||Number
2719537|NCT01103323|Secondary|Objective Tumor Response|The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Percentage of participants|||Number
2719538|NCT01103323|Secondary|Progression-free Survival (Based on Investigator's Assessment)|Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Days||95% Confidence Interval|Median
2719655|NCT01102270|Primary|Apnea Hypopnea Index|number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe|8 hour In-Laboratory Polysomnogram (PSG)||||events per hour of sleep||Standard Error|Mean
2719539|NCT01103323|Primary|Overall Survival|Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).|Intent to treat (ITT)|||Days||95% Confidence Interval|Median
2719540|NCT01103284|Secondary|Mean Number of Days With at Least One Hypoglycemic Event||Baseline to 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit|||days||Standard Error|Mean
2719541|NCT01103284|Secondary|Frequency of Hypoglycemic Events|Total number of days with at least one hypoglycemic event recorded|Baseline to 25 Months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit|||days|||Number
2719542|NCT01103284|Other Pre-specified|Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study|Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.|||percentage of subjects||95% Confidence Interval|Number
2719543|NCT01103284|Secondary|Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%|The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.|||percentage of subjects||95% Confidence Interval|Number
2719544|NCT01103284|Primary|Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months|Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit|||nmol*min/L||Standard Error|Mean
2719545|NCT01103271|Secondary|Pre-Post Efficacy|The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.|Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)||||units on a scale||Standard Deviation|Mean
2719546|NCT01103271|Primary|Feasibility|The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.|One year|The number of participants analyzed is the number of participants screened.|||screens|||Number
2719547|NCT01103245|Primary|Plasma Glucose|Fasting plasma glucose, measured during hyperglycemic clamp|at the end of each 1 month study period ( 3 times in total)|2 participants were excluded from the final analysis because they did not complete any of the Hyperglycemic clamps:1 from the HCTZ plus ALI150 then ALI 300 group and 1 participant from the HCTZ plus SPL 25 then ALI 150 and SPL 25 group|||mg/dl||Standard Deviation|Mean
2719548|NCT01103245|Primary|Plasma Insulin|A Hyperglycemic clamp was performed once during each study period to assess glucose stimulated insulin secretion. Glucose is infused intravenously to maintain blood glucose near 200 mg/dL to stimulate insulin secretion. During this time plasma insulin levels were measured and the insulin response is reported as the incremental increase over the first 10 minutes of glucose administration.|at the end of each 1 month study period ( 3 times in total)|2 participants were excluded from the final analysis because they did not complete any of the Hyperglycemic clamps:1 from the HCTZ plus ALI150 then ALI 300 group and 1 participant from the HCTZ plus SPL 25 then ALI 150 and SPL 25 group.|||uU/ml||Standard Deviation|Mean
2719549|NCT01103232|Primary|Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles|Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.|6 weeks (The change calculated as 6 months minus baseline)||||Newton meters||Standard Deviation|Mean
2719550|NCT01103180|Secondary|Depressive Symptoms|Depressive symptoms was assessed via (a) electronic diary (i.e. sum of eight POMS-D items: sad, unhappy, blue, hopeless, discouraged, miserable, helpless and worthless rated using 0-4 scale above) and (b) weekly interview(Hamilton depression rating)|baseline (week 0) and post treatment (week 8).|Data was not collected because the study was terminated.||||||
2719551|NCT01103180|Primary|Self-harm Ideation|Self-harm ideation was measured by electronic diaries (EMA) up to four times a day. Each time a person completed an EMA diary they were asked to rate their urge to hurt themselves on a 5 point scale ( 0 to 4) pad where 0 is not at all, 2 is moderately and 4 is extremely strong.|pre-treatment (week 0) to post-treatment (end of week 8)|Data was not collected because the study was terminated.||||||
2719552|NCT01103141|Primary|Major Peripheral Vascular Events|Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral|7 - 14 days||||participants|||Number
2719656|NCT01102270|Secondary|Nadir Overnight Oxygen Saturation|Nadir overnight oxygen saturation (%)|8 hour In-Laboratory Polysomnogram (PSG)||||% oxygen saturation||Standard Error|Mean
2719657|NCT01102270|Secondary|Arousal Threshold|quantified using an epiglottic pressure transducer in CmH2O|8 hour In-Laboratory Polysomnogram (PSG)||||cmH2O||Inter-Quartile Range|Median
2719553|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.|||Percentage of participants|||Number
2719554|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.|||Percentage of participants|||Number
2719555|NCT01103063|Secondary|Percentage of Participants With Pre-eclampsia From Week 20 to Delivery|Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.|From Week 20 to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N= Number of participants with available data.|||Percentage of participants||95% Confidence Interval|Number
2719556|NCT01103063|Secondary|Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery|Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.|Up to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.|||Percentage of participants||95% Confidence Interval|Number
2719557|NCT01103063|Secondary|Percentage of Neonates With Ophthalmia Neonatorum at Birth Period|Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Total live births.|||Percentage of neonates||95% Confidence Interval|Number
2719558|NCT01103063|Secondary|Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.|Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
2719559|NCT01103063|Secondary|Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation|Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
2719560|NCT01103063|Secondary|Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation|Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
2719561|NCT01103063|Secondary|Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation|Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
2719562|NCT01103063|Secondary|Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation|Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with lab test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
2719563|NCT01103063|Secondary|Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation|Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.|Upto 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.|||Percentage of participants||95% Confidence Interval|Number
2719658|NCT01102257|Primary|Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content||Baseline and 3 Months||||Percentage Total Fatty Acids||Inter-Quartile Range|Median
2719659|NCT01102257|Secondary|Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines||90 +/- 14 days following initiation of drug regimen|||||||
2719564|NCT01103063|Secondary|Percentage of Participants With Cord Blood Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with cord blood smear parasite counts at delivery.|||Percentage of participants||95% Confidence Interval|Number
2719565|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at delivery.|||Percentage of participants||95% Confidence Interval|Number
2719566|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
2719567|NCT01103063|Secondary|Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery|This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.|||Percentage of participants||95% Confidence Interval|Number
2719568|NCT01103063|Secondary|Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery|This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.|||Number of episodes||95% Confidence Interval|Least Squares Mean
2719569|NCT01103063|Secondary|Birth Weight of Live Borne Neonate|Birth weight of live borne neonates were calculated in grams.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of live births with available data.|||grams||95% Confidence Interval|Least Squares Mean
2719570|NCT01103063|Secondary|Percentage of Perinatal or Neonatal Deaths|Percentage of perinatal or neonatal deaths were noted.|Day 28 after delivery.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.|||Percentage of neonates||95% Confidence Interval|Number
2719571|NCT01103063|Secondary|Percentage of Neonates With Congenital Abnormalities at Birth|Neonates with congenital abnormalities at birth were noted.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.|||Percentage of neonates||95% Confidence Interval|Number
2719572|NCT01103063|Secondary|Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.|Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.|Baseline, at 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.|||g/dL||95% Confidence Interval|Least Squares Mean
2719573|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation|Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total Outcomes.|||Percentage of participants||95% Confidence Interval|Number
2719574|NCT01103063|Secondary|Sexually Transmitted Infection (STI) Episodes Per Participant|Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).|Approximately 40 weeks of gestational age .|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.|||Number of episodes||95% Confidence Interval|Least Squares Mean
2719660|NCT01102257|Secondary|Change in Schirmer's||90 +/- 14 days following initiation of drug regimen|||||||
2719661|NCT01102257|Secondary|Change in the Ocular Surface||90 +/- 14 days following initiation of drug regimen|||||||
2719575|NCT01103063|Secondary|Percentage of Participants With Placental Malaria at Delivery Based on Histology|Participants positive for placental malaria at delivery were evaluated based on placental histology.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with a histology parasite evaluation at delivery.|||Percentage of participants||95% Confidence Interval|Number
2719576|NCT01103063|Secondary|Percentage of Participants With Placental Parasitemia at Delivery|Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with placental parasite counts at delivery.|||Percentage of participants||95% Confidence Interval|Number
2719577|NCT01103063|Secondary|Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation|Anemia was defined as Hb <11 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.|||Percentage of Participants||95% Confidence Interval|Number
2719578|NCT01103063|Secondary|Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation|Severe maternal anemia was defined as Hb <8 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.|||Percentage of participants||95% Confidence Interval|Number
2719579|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. N=Total Live Births.|||Percentage of neonates||95% Confidence Interval|Number
2719580|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in ITT Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total live births.|||Percentage of neonates||95% Confidence Interval|Number
2719581|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.|||Percentage of Participants||95% Confidence Interval|Number
2719582|NCT01103063|Primary|Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.|||Percentage of participants||95% Confidence Interval|Number
2719583|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 48|Safety Population|||participants|||Number
2719584|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 24|Safety Population|||participants|||Number
2719585|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.|||participants|||Number
2719662|NCT01102257|Secondary|Change in Quality of Life Associated With Chronic Pain||90 +/- 14 days following initiation of drug regimen|||||||
2719586|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.|||participants|||Number
2719587|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.|||participants|||Number
2719588|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.|||participants|||Number
2719589|NCT01102972|Secondary|Number of Participants Who Experienced Death and/or Disease Progression|Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.|From Baseline to Week 48|ITT-E Population|||participants|||Number
2719590|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48|The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 48|ITT-E Population|||participants|||Number
2719591|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24|The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 24|ITT-E Population|||participants|||Number
2719592|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 48|A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.|||ratio||Standard Deviation|Mean
2719593|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2719594|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 24|A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.|||ratio||Standard Deviation|Mean
2719595|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2719663|NCT01102257|Secondary|Change on Impact of Dry Eye on Everyday Life (IDEEL)||90 +/- 14 days following initiation of drug regimen|||||||
2719596|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 48|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.|||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
2719597|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 24|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.|||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
2719598|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 48|Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.|||log10 copies/mL||Standard Deviation|Mean
2719599|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 24|Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.|||log10 copies/mL||Standard Deviation|Mean
2719600|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.|||Percentage of participants|||Number
2719601|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.|||percentage of participants|||Number
2719602|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 48|ITT-E Population|||Percentage of participants|||Number
2719603|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 24|ITT-E Population. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <400 copies/mL at Week 24.|||percentage of participants|||Number
2719604|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.|||Percentage of participants|||Number
2719605|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.|||percentage of participants|||Number
2719620|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Nine Control and seventeen Intervention participants were missing data at 12 months.|||units on a scale||Standard Deviation|Mean
2719606|NCT01102972|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.|Week 24|Intent-to-Treat (ITT)-Exposed Population: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <50 copies/mL at Week 24.|||percentage of participants|||Number
2719607|NCT01102894|Secondary|Food Intake Diary|Total dietary fiber consumed.|Day 1|Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake|||g||Standard Deviation|Mean
2719608|NCT01102894|Secondary|Gastrointestinal Tolerance|Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.|Day 4|Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.|||units on a scale||Standard Deviation|Mean
2719609|NCT01102894|Primary|Whole Gut Transit Time|The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.|5 days|All participants had their transit time assessed.|||hours||Standard Deviation|Mean
2719610|NCT01102803|Secondary|Behavioral Avoidance Test (BAT)|During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0-100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome.|2 months||||units on a scale||Standard Deviation|Mean
2719611|NCT01102803|Secondary|Clinical Global Improvement Scale (CGI)|"Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either very much improved or much improved on CGI-I (score ≤ 2). Remission was defined as either normal or minimally ill on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome."|2 months||||units on a scale||Standard Deviation|Mean
2719612|NCT01102803|Secondary|Attitudes Towards Heights Questionnaire (ATHQ)|Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0-10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60.|2 months||||units on a scale||Standard Deviation|Mean
2719613|NCT01102803|Primary|Acrophobia Questionnaire With Avoidance (AAVQ)|Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0-3) and anxiety (0-6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82-.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.|2 months||||units on a scale||Standard Deviation|Mean
2719614|NCT01102777|Secondary|Change in Participant Satisfaction|"Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is Definitely True 5 is Definitely False to the question, I would recommend the Taking Healthy Steps walking program to another person with COPD. A negative change value indicates higher satisfaction score."|four to twelve months of study participation|This was only assessed on Intervention group participants who answered the question at either four or twelve months.|||units on a scale||95% Confidence Interval|Mean
2719615|NCT01102777|Secondary|Participant Retention|The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.|during study participation, up to twelve months||||day||95% Confidence Interval|Mean
2719616|NCT01102777|Secondary|Study Reach Among Rural Participants|Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.|At baseline|number of rural participants.|||percentage of possible eligible rural|||Number
2719617|NCT01102777|Secondary|Goal Commitment for Intervention Participants|"Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as Strongly Disagree and 5 is Strongly Agree to the question, I am strongly committed to pursuing my step count goal. A negative change value indicates lower goal commitment."|change from four months and twelve months from enrollment|This measure was only assessed on the Intervention group, and only 146 participants answered the question at either time points.|||units on a scale||95% Confidence Interval|Mean
2719618|NCT01102777|Secondary|Change in Average Daily Step Counts|Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.|baseline and final two weeks of the intervention and the two weeks post intervention.|One Intervention participant was dropped from analysis due to being an extreme outlier.|||steps||95% Confidence Interval|Mean
2719619|NCT01102777|Secondary|Days of Hospitalization|Number of days of all-cause hospitalization during study participation.|during study participation, up to 12 months||||days|||Number
2719621|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Three Control and ten Intervention were missing values at 4 months.|||units on a scale||Standard Deviation|Mean
2719622|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier.|||units on a scale||95% Confidence Interval|Mean
2719623|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. In addition, not all participants had complete SGRQ data at both time points for analysis.|||units on a scale||Standard Deviation|Mean
2719624|NCT01102764|Secondary|Prior Experience With Computer and Audiovisual Technology|The Prior Experience With Technology questionnaire is an 8-item short measure to learn more about participants' prior experiences and comfort level with computers and audiovisual technology. For 8 different technological devices, the measure asks if the participant has the device in his/her home (i.e. Is there a telephone in your home)? Subsequent questions determine whether the patient is comfortable using that device or, if he/she does not own one, if he/she would be willing to learn to use one. Devices assessed include telephone, television, stereo, video player (e.g. VCR, DVD), computer, internet, e-mail, and audiovisual conferencing technology. These data may help identify whether these variables are associated with clinical outcome.|Week 0|The outcome data for this measure is not available because there was not enough sufficient responses to generate analyses.||||||
2719625|NCT01102764|Secondary|Structured Clinical Interview for DSM-IV (SCID-I)|"The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) is a semistructured interview to determine whether an individual meets criteria for any Axis I disorder in the Diagnostic and Statistical Manual of Mental Disorders (version IV). The SCID is broken down into separate modules corresponding to categories of diagnoses, and uses skip logic to allow the interviewer to skip questions or modules if certain diagnostic criteria are indicated. Most sections begin with an entry question that would allow the interviewer to skip the associated questions if not met. For all diagnoses symptoms are coded as present, subthreshold, or absent. It assesses for both current and lifetime diagnoses and prompts the interviewer to document age of illness onset and to rate current illness severity (Glasofer et al., 2015)."|26 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||percentage of participants|||Number
2719626|NCT01102764|Secondary|Service Delivery Perceptions Questionnaire|This measure is used to assess Veterans' perceptions about variables specifically related to this mode of service delivery (e.g., the quality of communication, ease of use, and willingness to use treatment via videoconferencing in the future). There are 8 questions (1 question was not assessed due to asking about group participation which is irrelevant to the current study). All questions are answered via a 5 point Likert scale, with 1 indicating poor perceptions and 5 indicating excellent perceptions. Scores range from 7-35, with higher scores indicating more positive outcomes.|26 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||units on a scale||Full Range|Mean
2719627|NCT01102764|Secondary|Treatment Credibility|This measures assesses for differences in outcome expectancy. The Treatment Credibility Scale (as used in this study) contains 4 questions. Each question is scored individually via 10-point Likert scales. Questions asses how logical treatment seems, how confident participants are about treatment, and expectations of success and is administered at treatment session 4. Scores on treatment logicality, confidence and predicted success on each question range from 1 (not at all) to 10 (very logical), with mid-range scores indicating moderate logicality, confidence and predicted success.|4 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||scores on a scale||Full Range|Mean
2719628|NCT01102764|Secondary|Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)|"The CPOSS is a 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. Extant data demonstrate that the measure has excellent reliability (alpha = 0.96) and good convergent validity with relevant anchor items (would you recommend this treatment to a friend or family member?). Items are scored using a 5 point Likert scale (5=excellent; 4=very good; 3=good; 2=fair; 1=poor). The scale is scored by summing the scores of all individual items. The possible range is 16 to 80, with higher scores indicating higher satisfaction."|14 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||score on a scale||Full Range|Mean
2719629|NCT01102764|Secondary|Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)|The MOS SF-36 is an indicator of overall health status. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each of the eight summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Therefore, lower scores indicate more disability while higher scores indicate less disability. Each subscale can be used independently. Sections of the SF-36 include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.|26 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||percentage of participants|||Number
2719650|NCT01102374|Secondary|Change in 25-hydroxyvitamin D (25OHD) Level||Baseline and 12 months||||ng/mL||Standard Error|Mean
2719651|NCT01102374|Secondary|Time to First ARI||12 months||||Hazard Ratio|||Number
2719630|NCT01102764|Secondary|Deployment Risk and Resiliency Inventory (DRRI)|The DRRI is collection of self-report measures assessing 14 key deployment-related risk and resilience factors with demonstrated implications for veterans' long-term health. With the nature of military deployment changing, with a larger proportion of women, National Guard and Reserves being deployed for more contemporary conflicts, the DRRI was developed to provide a more comprehensive assessment of the current combat-related experiences. The DRRI is made up of multiple scales to represent different constructs. Responses are either dichotomous (0=No, 1=Yes), polytomous (0=No, 1=Not Sure, 2=Yes), or recorded on a 4, 5 or 6 point Likert scales. Scores for each section are summed are contain scoring ranges. Higher scores are indicative of worse outcomes.|Week 0|The outcome data for this measure is not available because there was not enough sufficient responses to generate analyses.||||||
2719631|NCT01102764|Secondary|Clinician Administered PTSD Scale for DSM-IV (CAPS IV)|"The Clinician Administered PTSD Scale (CAPS) is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-IV criteria for PTSD diagnoses, with B, C, and D symptoms rated for both frequency and intensity; these two scores (frequency + intensity) are summed to provide severity ratings. Additional questions assess Criteria A, E, and F. It is recommended that the 1, 2 rule be used to determine whether a symptom meets criteria; that is, a frequency score of at least 1 (scale 0 = none of the time to 4 = most or all of the time) and an intensity score of at least 2 (scale 0 = none to 4 = extreme) is required for a particular symptom to meet criteria. Total scores from B, C and D range from 0 to 136, with lower scores indicating better outcomes, and higher scores indicating worse outcomes."|26 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||scores on a scale||Full Range|Mean
2719632|NCT01102764|Primary|Beck Depression Inventory-II (BDI-II)|Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.|26 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||score on a scale||Full Range|Mean
2719633|NCT01102764|Primary|PTSD Checklist-Military (PCL-M)|PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). Total scores on the PCL range from 17 to 85, with lower scores indicating less symptom severity.|26 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||score on a scale||Full Range|Mean
2719634|NCT01102764|Primary|Treatment Completion|The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes. Per protocol, participants could have as many as 12 treatment sessions. Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions.|13 weeks|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||sessions||Full Range|Mean
2719635|NCT01102491|Secondary|Incidence of Rescue Antiemetic Administration|outcome assessor assessed the incidence of rescue antiemetic administration|within 48 hours after surgery|||||||
2719636|NCT01102491|Primary|Incidence of Nausea and Vomiting|outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting|within 48 hours after surgery||||participants|||Number
2719637|NCT01102413|Secondary|Change in Hemoglobin Concentration From Baseline to Week 8||Baseline to week 8|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
2719638|NCT01102413|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.||Baseline, 4 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
2719639|NCT01102374|Secondary|Number of Other Infections||12 months||||events|||Number
2719640|NCT01102374|Secondary|Number of Urinary Tract Infections||12 months||||events|||Number
2719641|NCT01102374|Secondary|Death||12 months||||Participants|||Count of Participants
2719642|NCT01102374|Secondary|Incident Hypercalcemia||12 months||||Participants|||Count of Participants
2719643|NCT01102374|Secondary|Incident Kidney Stones||12 months||||Participants|||Count of Participants
2719644|NCT01102374|Secondary|Number of Influenza-like Illnesses||12 months|collected together with lower respiratory infections (not as a separate category)||||||
2719645|NCT01102374|Secondary|Number of Lower Respiratory Infections||12 months||||events|||Number
2719646|NCT01102374|Secondary|Number of Upper Respiratory Infections||12 months||||events|||Number
2719647|NCT01102374|Secondary|Fractures||12 months||||events|||Number
2719648|NCT01102374|Secondary|Falls||12 months||||Events|||Number
2719649|NCT01102374|Secondary|Change in Parathyroid Hormone Level||Baseline and 12 months|Issue relating to sample collection/processing precluded measurement of PTH level in the trial||||||
2719669|NCT01102140|Secondary|Asymmetric Dimethylarginine (ADMA)|ADMA is a serum enzyme involved in metabolism of endothelium derived nitric oxide (NO). NO's has an important role in maintaining endothelial homeostasis. Elevated ADMA levels suggest impaired endothelial function.|baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain ADMA values due to PI departure from study center prior to any batches being sent for analysis||||||
2719670|NCT01102140|Secondary|Procollagen Types I (PINP) and III (PIIINP)|This is a serum marker of collagen turnover (fibrosis/scar formation).|baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain procollagen values due to PI departure from study center prior to any batches being sent for analysis||||||
2719671|NCT01102140|Secondary|F-8 Isoprostanes|This is a serum marker of oxidative stress.|Baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis||||||
2719672|NCT01102140|Primary|Thiobarbituric Reactive Substances (TBARS)|This is a serum marker of oxidative stress.|baseline and after 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis.||||||
2719673|NCT01101971|Primary|Score on Pelvic Exam Assessment Tool|A pelvic exam assessment score out of 30 is recorded by a Resident examiner immediately after a student completes their first pelvic examination on a mock patient. Pass = 15/30 (50%).|15 minutes||||points||Standard Deviation|Mean
2719674|NCT01101958|Primary|Lung Volume Change||30 Days|Per protocol population analyzed [16 subjects have been excluded due to the following reasons: lacked HRCT(n=6), Lost to Follow-Up (n=8) or died (n=2) of unrelated causes].|||percent decrease in lung volume||Inter-Quartile Range|Median
2719675|NCT01101880|Primary|Overall Survival|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.|Up to 5 years||||months||95% Confidence Interval|Median
2719676|NCT01101880|Primary|Treatment-related Mortality (TRM)|Treatment-related mortality (TRM) data was not collected.|Up to 5 years|Treatment-related mortality (TRM) data was not collected.||||||
2719677|NCT01101880|Primary|Event Free Survival|Number of patients in remission at a median follow up of 15 months.|Up to 5 years||||Participants|||Count of Participants
2719678|NCT01101880|Primary|Time to Progression|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.|Up to 5 years||||weeks||Full Range|Median
2719679|NCT01101880|Primary|Duration of Remission|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues).|Up to 5 years||||weeks||Full Range|Median
2719680|NCT01101880|Primary|Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).|Up to 5 years|CR achieved with no AHD only applies to those who did not have AHD.|||Participants|||Count of Participants
2719681|NCT01101867|Secondary|1,5-anhydroglucitol Change|change in short-term measure of glycemia|day 1 to day 3|subjects with complete data|||mcg/ml||Standard Deviation|Mean
2719682|NCT01101867|Secondary|Treatment Satisfaction|treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.|day 3|all participants who completed the survey|||points on a scale||Standard Deviation|Mean
2719683|NCT01101867|Secondary|Change in Glucose|Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.|72 hour|intention to treat population|||mg/dl||Standard Deviation|Mean
2719684|NCT01101867|Secondary|Hypoglycemia|Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)|72 hour||||participants|||Number
2719685|NCT01101867|Secondary|Postprandial Glucose|Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.|||mg/dl||Standard Deviation|Mean
2719686|NCT01101867|Primary|Mean Glucose|Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.|||mg/dl||Standard Deviation|Mean
2719687|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity Score per day||Standard Deviation|Mean
2719688|NCT01101841|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||kg/m2||Full Range|Median
2719689|NCT01101841|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
2719690|NCT01101841|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percentage of participants|||Number
2719691|NCT01101841|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of Very Much Improved Or Much Improved Or Minimally Improved.~Non Responders: Subjects with a Score of No Change Or Minimally Worse Or Much Worse Or Very Much Worse."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
2719692|NCT01101841|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
2719693|NCT01101841|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Units on a scale||Full Range|Median
2719694|NCT01101841|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of total number of subjects|||Number
2719695|NCT01101841|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
2719696|NCT01101841|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||units on a scale||Full Range|Median
2719697|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
2719698|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
2719699|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
2719700|NCT01101841|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Awakenings||Full Range|Median
2719701|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
2719712|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
2719702|NCT01101841|Secondary|Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.|"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:~Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%."|Week 24|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of total number of subjects|||Number
2719703|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per day||Standard Deviation|Mean
2719704|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
2719705|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).||||Subjects|||Number
2719706|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).||||Subjects|||Number
2719707|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).||||Subjects|||Number
2719708|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).||||Subjects|||Number
2719709|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)|*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.||||||
2719710|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
2719711|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
2719756|NCT01101035|Secondary|Percentage of Participants With Non-fatal Stroke|Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal stroke.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719713|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
2719714|NCT01101477|Secondary|The Global Tolerance for Flexible Bronchoscopy|After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)|After recovery|||||||
2719715|NCT01101477|Secondary|The Cooperation of Patients From the View of Bronchoscopists|After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.|After bronchoscopy|||||||
2719716|NCT01101477|Secondary|The Total Doses of Propofol During Induction and Overall Procedures|The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.|after bronchoscopy|||||||
2719717|NCT01101477|Secondary|The Recovery Time to Orientation|The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.|after bronchosocpy|||||||
2719718|NCT01101477|Primary|The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy|The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.|During sedative induction and bronchoscopy|||||||
2719719|NCT01101477|Primary|The Number of Patients With Hypoxemia During Flexible Bronchoscopy|"Hypoxemia is defined as:~Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration"|During sedative induction and bronchoscopy|The participants who received intervention completely were analyzed.|||participants|||Number
2719720|NCT01101464|Primary|Pharmacokinetic Parameter of Area Under the Curve (AUC) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).|||ng*h/mL||Standard Deviation|Mean
2719721|NCT01101464|Primary|Pharmacokinetic Parameter of Time of Occurrence of Cmax (Tmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2"|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).|||Hours||Full Range|Mean
2719722|NCT01101464|Primary|Pharmacokinetic Parameter of Maximum Plasma Concentration (Cmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).|||ng/mL||Standard Deviation|Mean
2719723|NCT01101321|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2719724|NCT01101321|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2719725|NCT01101321|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2719726|NCT01101308|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719757|NCT01101035|Secondary|Percentage of Participants With Non-fatal Myocardial Infarction (MI)|Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal MI.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719727|NCT01101308|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719728|NCT01101308|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719729|NCT01101191|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719730|NCT01101191|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719731|NCT01101191|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over a 72-hour period.|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719732|NCT01101178|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics; Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719733|NCT01101178|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.|Blood samples collected over 72-hour period|Full Analysis Population for pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719734|NCT01101178|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719735|NCT01101165|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in period 2 was excluded from this PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719736|NCT01101165|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in Period 2 was excluded from this PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719737|NCT01101165|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719738|NCT01101100|Primary|Percent Change in Psoriasis Area and Severity Index (PASI)|Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.|264 weeks|Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit.|||Percentage change||Standard Deviation|Mean
2719739|NCT01101100|Primary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)|Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)|264 weeks|Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit.|||Participants|||Count of Participants
2719740|NCT01101061|Secondary|Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab|||days||Standard Deviation|Mean
2719741|NCT01101061|Secondary|Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab with available T1/2,β data|||days||Standard Deviation|Mean
2719742|NCT01101061|Secondary|Apparent Clearance (CL/F) of Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab|||mL/day/kg||Standard Deviation|Mean
2719743|NCT01101061|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab|||µg*day/mL||Standard Deviation|Mean
2719744|NCT01101061|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab|||µg*day/mL||Standard Deviation|Mean
2719745|NCT01101061|Secondary|Maximum Observed Concentration of Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab|||µg/mL||Standard Deviation|Mean
2719746|NCT01101061|Secondary|Time to Maximum Observed Concentration of Romosozumab|Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.|Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.|All treated participants who received romosozumab|||days||Full Range|Median
2719747|NCT01101061|Secondary|Percent Change From Baseline in Sclerostin||Baseline and days 12, 29, 43, 57, 71, and 85|All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85.|||percent change||Standard Error|Mean
2719748|NCT01101061|Secondary|Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)||Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85|All treated participants|||percent change||Standard Error|Mean
2719749|NCT01101061|Secondary|Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)||Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85|All treated participants|||percent change||Standard Error|Mean
2719750|NCT01101061|Primary|Serum Intact Parathyroid Hormone (iPTH) Levels||Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85|All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85|||pmol/L||Standard Error|Mean
2719751|NCT01101061|Primary|Serum Calcium Levels||Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85|All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85.|||mmol/L||Standard Error|Mean
2719752|NCT01101061|Primary|Number of Participants Who Developed Anti-romosozumab Binding Antibodies|Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.|Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)|All treated participants|||Participants|||Count of Participants
2719753|NCT01101061|Primary|Number of Participants With Adverse Events|"A serious adverse event (SAE) is defined as an adverse event that~is fatal~is life threatening~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product."|Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.|All treated participants|||Participants|||Count of Participants
2719754|NCT01101035|Primary|Percentage of Participants With Primary MACE Composite (Final Analysis)|Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719755|NCT01101035|Secondary|Percentage of Participants With Unstable Angina With Urgent Coronary Revascularization|Events were adjudicated by an independent cardiovascular endpoints committee as unstable angina with urgent coronary revascularization.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719758|NCT01101035|Secondary|Percentage of Participants With Cardiovascular (CV) Death|Events were adjudicated by an independent cardiovascular endpoints committee as CV death.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719759|NCT01101035|Secondary|Percentage of Participants With Antiplatelet Trialists' Collaborative (APTC) Event|APTC events were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719760|NCT01101035|Primary|Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)|Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.|Up to last dose of study drug (approximately 83 months)|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2719761|NCT01101022|Secondary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks|AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2719762|NCT01101022|Secondary|Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
2719763|NCT01101022|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
2719764|NCT01101022|Secondary|Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks|"Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating.~Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life."|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2719765|NCT01101022|Secondary|Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2719766|NCT01101022|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 10 weeks post-dose|FAS|||Percent of participants|||Number
2719767|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 10 weeks post-dose|FAS|||Percent of participants|||Number
2719768|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS|||Percent of participants|||Number
2719769|NCT01101022|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Lower scores indicate reduction in symptoms.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2719770|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
2719771|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
2719785|NCT01100944|Secondary|Time to Half Life (t1/2) of Belinostat|Half life is the duration of time for the drug to be reduced to half the original amount.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose.||||Hour||Standard Deviation|Mean
2719772|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Mean
2719773|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
2719774|NCT01101022|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2719775|NCT01101022|Primary|Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|Full Analysis Set (FAS) defined as all subjects who took 1 dose of investigational product in the double-blind evaluation phase and had 1 primary efficacy assessment.|||T-scores||Standard Error|Least Squares Mean
2719776|NCT01100944|Secondary|Relative Changes in T Cell Immunoglobulin Domain and Mucin Domain-3 (TIM3)-Expressing Cluster of Differentiation 8 (CD8)+Tcells|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.|||Relative fold change||Full Range|Median
2719777|NCT01100944|Secondary|Relative Changes in the Number of Tregs With Treatment|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.|||relative fold change||Full Range|Median
2719778|NCT01100944|Secondary|Relative Change Observed in Total Protein Hyperacetylation of Cluster of Differentiation 3 (CD3)+T Cells With Belinostat|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Two samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.|||Relative fold change||Full Range|Median
2719779|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)/Dose|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||hr*ng/ml/mg||Standard Deviation|Mean
2719780|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF))|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||hr*ng/ml||Standard Deviation|Mean
2719781|NCT01100944|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to reach peak concentration after drug administration.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||Hour||Standard Deviation|Mean
2719782|NCT01100944|Secondary|Maximum Plasma Concentration (Cmax)/Dose|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||ng/ml/mg||Standard Deviation|Mean
2719783|NCT01100944|Secondary|Maximum Observed Plasma Concentration (Cmax) of Belinostat|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|One patient was excluded from pharmacokinetic analysis due to insufficient sampling in dose level 2. Dose normalized parameters are normalized to absolute total dose (over 48 hours continuous intravenous infusion (CIVI)) for that patient, not dose level.|||ng/ml||Standard Deviation|Mean
2719784|NCT01100944|Secondary|Total Clearance (CL) of Belinostat|Clearance is the amount of time for the drug to be eliminated from the body.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||L/hr||Standard Deviation|Mean
2719786|NCT01100944|Secondary|Overall Survival (OS)|Overall survival is defined as the on-study date until the date of death or progression as appropriate.|Start of treatment to time of death, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.|||months||Full Range|Median
2719787|NCT01100944|Secondary|Progression Free Survival (PFS)|Duration of time from start of treatment to time of progression or death whichever occurs first.|Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.|||months||Full Range|Median
2719788|NCT01100944|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria (e.g. Response Evaluation Criteria in Solid Tumors (RECIST)) are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|From the time of first response until date of progression, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response|||months||95% Confidence Interval|Median
2719789|NCT01100944|Secondary|Time to Response|Time to response is the time between the first day of treatment until first date of response (complete response (CR) + partial response (PR)) (whichever is first recorded).|From the first day of treatment until the date of first documented response, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||days||Full Range|Median
2719790|NCT01100944|Secondary|Disease Control Rate (DCR)|DCR is defined as stable disease (SD) + partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST).|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||percentage of participants||95% Confidence Interval|Number
2719791|NCT01100944|Secondary|Clinical Response|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||Participants|||Count of Participants
2719792|NCT01100944|Secondary|Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient)|Here are the number of patients with treatment -related grade 3 and 4 adverse events (highest grade per event per patient).|up to 122 months||||Participants|||Count of Participants
2719793|NCT01100944|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of events, see the adverse event module.|up to 122 months||||Participants|||Count of Participants
2719794|NCT01100944|Primary|Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies|Objective response rate is the number of participants with a best objective response of partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST) divided by the number of participants who had treatment.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||percentage of participants||95% Confidence Interval|Number
2719795|NCT01100944|Primary|Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat|A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|up to 122 months||||Participants|||Count of Participants
2719796|NCT01100944|Primary|Maximum Tolerated Dose (MTD) of Belinostat|The MTD is defined as the highest dose at which less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|2 years||||mg/m(2)|||Number
2719797|NCT01100931|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|31.5 months||||Participants|||Number
2719798|NCT01100931|Primary|Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 18 weeks|Phase I is not included here because this outcome measure is for phase II only.|||Participants|||Number
2719799|NCT01100931|Primary|Phase 1 Safe and Tolerable Phase 2 Dose.|"Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).~Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1."|1 year|Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m^2.|||mg/m^2|||Number
2719800|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines) Amphetamine||24 weeks||||Urine Drug Screen|||Number
2719801|NCT01100853|Secondary|Prior Admissions to Vogur Hospital|"Number of prior admissions due to substance dependence. The term prior admissions refers to admissions before enrollment, thus Baseline is the appropriate Time Frame."|Baseline||||Number of admissions||Standard Deviation|Mean
2719802|NCT01100853|Secondary|Risk Assessment Battery|The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.|24 weeks||||Total Score||Standard Deviation|Mean
2719803|NCT01100853|Secondary|Beck Depression Inventory|The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.|24 weeks||||BDI Score||Standard Deviation|Mean
2719804|NCT01100853|Secondary|Amphetamine Craving Scale|The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.|24 weeks||||VAS Score||Standard Deviation|Mean
2719805|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines)||24 Weeks|Urine drug screens negative amphetamine|||Urine Drug Screen|||Number
2719806|NCT01100762|Primary|First Step Velocity|First step velocity was measured in meters per second|Data collection occurred before and immediately after each training session||||m/sec||Standard Deviation|Mean
2719807|NCT01100762|Primary|First Step Length|First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.|Data collection occurred before and immediately after each training session||||m||Standard Deviation|Mean
2719808|NCT01100762|Primary|Number of Steps to Regain Balance|Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.|Data collection occurred before and immediately after each training session||||steps||Standard Deviation|Mean
2719809|NCT01100762|Primary|Cadence|Cadence was measured in steps per minute|Data collection occurred before and immediately after each training session||||steps/min||Standard Deviation|Mean
2719810|NCT01100762|Primary|Gait Velocity|Gait Velocity was measured in meters per second|Data collection occurred before and immediately after each training session||||m/s||Standard Deviation|Mean
2719811|NCT01100762|Primary|Stride Length|Stride Length was measured in centimeters|Data collection occurred before and immediately after each training session||||cm||Standard Deviation|Mean
2719812|NCT01100723|Secondary|Percent of Patients on Cinacalcet and Vitamin D Analogues|Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and at 6 and 12 months after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|6 months and 1 year|Number of subjects with at least 1 laboratory analysis during the evaluation period.|||percentage of subjects receiving med|||Number
2719813|NCT01100723|Secondary|Percent of Patients Achieving Calcium Target ≤ 10.1|Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects with at least one laboratory value during evaluation period.|||percentage of subjects in target|||Number
2719814|NCT01100723|Secondary|Percent of Patients Achieving Phosphorous Target ≤ 4.5|Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year||||percent of participants in target|||Number
2719815|NCT01100723|Secondary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 450|Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year||||percent of participants in target|||Number
2719816|NCT01100723|Primary|Percent of Patients Achieving Phosphorous Target ≤ 5.5|Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year||||percent of participants in target|||Number
2719817|NCT01100723|Primary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 300|Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects who had at least one laboratory measurement during the assessment phase.|||percentage of subjects meeting target|||Number
2719818|NCT01100658|Secondary|Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior|Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.||||||
2719819|NCT01100658|Primary|Effectiveness of Methylphenidate on Neurocognitive Components|Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.||||||
2719820|NCT01100606|Primary|Question 6 (Previous Pancreatic Enzyme Product [PEP])|"Acceptability questionnaire consists of 9 questions (Q) to assess the ease, time, overall satisfaction of study drug. Q6 included name of previous PEP administered. Q6 was reported as number of participants who used any PEP prior to screening."|Baseline|Safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2719821|NCT01100606|Primary|Treatment Difference for Acceptability of Treatment|Acceptability questionnaire consists of 9 question (Q) to assess ease, time, overall satisfaction of study drug. Rated on 5-point scale for Q1-Q5 and Q7-Q9; Q6 was not rated and asked for name of previous PEP administered. Q1=overall ease of administration (1=not at all easy,2=somewhat,3=easy,4=very,5=extremely); Q2=time of administration (1=very short[<2 min],2=short[2-5 min],3=moderate[5-15 min],4=long[15-25 min],5=very long[>25 min]);Q3=overall infant acceptance(1=very easily,2=easily,3=same,4=with difficulty,5=with great difficulty);Q4=clear/complete instructions(1=not clear,2=somewhat,3=clear,4=very,5=extremely);Q5=overall satisfaction with dosing method (1=not satisfied,2=somewhat,3=satisfied,4=very,5=extremely);Q7=comparative ease of administration (1=much worse,2=worse,3=same,4=better,5=much better);Q8=comparative infant acceptance (1=much more difficult,2=more,3=same,4=easier,5=much easier);Q9=comparative overall satisfaction (1=much less,2=less,3=same,4=more,5=much more).|Baseline up to end of study (Day 21)|Intention-to-treat (ITT) population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of exocrine pancreatic insufficiency (EPI). Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||units on a scale||Full Range|Median
2719822|NCT01100606|Secondary|Number of Participants With Abnormal Findings With Respect to Oral Mucosa|Safety assessed by the presence of lesions observed during a physical examination at each visit. Severity of lesions measured by investigator's assessment using the following scale: mild = asymptomatic or mild symptoms and treatment not indicated; moderate = moderate pain but not interfering with oral intake, modified diet indicated; severe = severe pain, interfering with oral intake and life threatening or fatal.|Baseline up to end of study (Day 21)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2719823|NCT01100606|Secondary|Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings||Baseline up to end of study (Day 21)|Data was reported in individual participant listings but not statistically summarized for analysis as planned.||||||
2719824|NCT01100606|Secondary|Number of Abdominal Pain Symptoms|Symptoms of pain was classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of pain symptoms per day||Standard Deviation|Mean
2719825|NCT01100606|Secondary|Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of flatulence per day||Standard Deviation|Mean
2719826|NCT01100606|Secondary|Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of bloating per day||Standard Deviation|Mean
2719827|NCT01100606|Secondary|Number of Stools With Signs of Blood and Visible Oil or Grease|Average number of stools with signs of blood and visible oil or grease of each participant was calculated from number of stools with signs of blood and visible oil or grease by the participant per day. Average number of stools with signs of blood and visible oil or grease during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of stools per day||Standard Deviation|Mean
2719828|NCT01100606|Secondary|Number of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and diarrhea. Average number of stools categorized as per consistency of each participant was calculated from number of stools of specific consistency by the participant per day. Average number of stools categorized as per consistency during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of stools per day||Standard Deviation|Mean
2719829|NCT01100606|Secondary|Daily Number of Stools|Average daily number of stools of each participant was calculated from frequency of stools by the participant per day. Average daily number of stools during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire on and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of stools per day||Standard Deviation|Mean
2719830|NCT01100567|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase||baseline to 5 days||||ug/L/day||95% Confidence Interval|Mean
2719831|NCT01100567|Primary|Change From Baseline in C-telopeptides||Baseline to 5 days||||ng/mL/day||95% Confidence Interval|Mean
2719832|NCT01100528|Secondary|Changes in Plasma Biomarkers and Their Association With DFS|Plasma levels of these markers will be summarized at baseline and over time quantitatively and graphically. Specific regulators of immune escape and tumor cell invasion identified in uveal melanoma gene array studies will be measured. Peripheral blood cells and plasma will be analyzed for granulysin (a measure of natural killer cells (NK) activity), beta2-microglobulin, autotoxin, lysophosphatidic acid (a product of autotaxin), matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.|5 yrs from start of treatment|Information not collected||||||
2719833|NCT01100528|Secondary|Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0|Number of participants with toxicity as defined as an underlying risk of >33% Grade 3 (non blood/bone marrow) or Grade 4 adverse events that are related to therapy, assessed by NCI CTCAE version 3.0|up to 32 weeks from start of study|All patients enrolled on study regardless of treatment|||Participants|||Count of Participants
2719834|NCT01100528|Primary|Number of Patients With Disease-free Survival (DFS)|DFS will be calculated from the date treatment starts to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier. Treatment will be considered relatively ineffective in this population if the underlying 2-year DFS is <60%, whereas the combination will be considered promising if the underlying rate is >80%.|5 years from time-of-enrollment|All patients enrolled in study|||Participants|||Count of Participants
2719835|NCT01100502|Secondary|Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin||Up to 12 months|ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)|||participants|||Number
2719836|NCT01100502|Secondary|Incidence of Adverse Events or Laboratory Abnormalities||Up to 12 months|Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis|||participants|||Number
2719837|NCT01100502|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause|Up to approximately 10 years||2021-04-30|04/2021||||
2719838|NCT01100502|Primary|Progression-free Survival by Independent Review|Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first|Up to approximately 4 years|Intention-to-Treat analysis set|||months||95% Confidence Interval|Median
2719839|NCT01100437|Other Pre-specified|Maximum Post-dose COWS in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Between 0.5 and 24 hours post-dose|ITT|||units on a scale||Standard Deviation|Mean
2719840|NCT01100437|Other Pre-specified|6-β-Naltrexone Plasma Concentration at First COWS ≥ 13 in Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of all participants with COWS ≥ 13|||pg/mL||Standard Deviation|Mean
2719844|NCT01100437|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category|||ng*h/mL||Standard Deviation|Mean
2719845|NCT01100437|Secondary|Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase|Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category|||ng*h/mL||Standard Deviation|Mean
2719846|NCT01100437|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase|Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category|||ng times h divided by mL (ng*h/mL)||Standard Deviation|Mean
2719847|NCT01100437|Secondary|Plasma Decay Half-Life (t1/2) During the Treatment Phase|Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category|||h||Standard Deviation|Mean
2719848|NCT01100437|Secondary|Volume of Distribution (Vd/F)During the Treatment Phase|Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable date for the specific category|||liter (L)||Standard Deviation|Mean
2719849|NCT01100437|Secondary|Apparent Oral Clearance (CL/F) During the Treatment Phase|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category|||liters/hour (L/h)||Standard Deviation|Mean
2719850|NCT01100437|Secondary|Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase|Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category|||ng/mL||Standard Deviation|Mean
2719851|NCT01100437|Secondary|Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase|Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2719852|NCT01100437|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase|Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|Pharmacokinetic (PK) population: all randomized participants who received at least one dose of EMBEDA (whole or crushed) in the Treatment Phase and had at least one PK assessment completed in the Treatment Phase; n=number of participants with evaluable data for the specific category|||hours (h)||Standard Deviation|Mean
2719853|NCT01100437|Secondary|Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases|Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10).|Baseline up to Day 63|ITT; N=number of participants with evaluable data; n=number of participants evaluated at the specific time point|||units on a scale||Standard Deviation|Mean
2719854|NCT01100437|Primary|Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)|Intent-to-treat population (ITT): all randomized participants who received at least one dose of double-blind treatment in the Treatment Phase and had at least one post-dose pharmacodynamic assessment completed in the Treatment Phase.|||participants|||Number
2719855|NCT01100320|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis|||ng*h/mL||Standard Deviation|Mean
2719856|NCT01100320|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719857|NCT01100320|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719858|NCT01100307|Other Pre-specified|Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.~Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.~Positive change indicated improvement."|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Units on a scale||Standard Deviation|Mean
2719859|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase|Retinal thickness was assessed by spectral-domain optical coherence tomography or OCT3000, a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719860|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719861|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719862|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.~Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 - 14 letters; Lost 1 - 9 Letters; No change or gained 1 - 9 letters; Gained 10 - 14 letters; Gained 15 letters or more."|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719863|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
2719864|NCT01100307|Other Pre-specified|Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.~Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.~Positive change indicated improvement."|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Units on a scale||Standard Deviation|Mean
2719865|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719866|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719867|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719868|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.~Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 - 14 letters; Lost 1 - 9 Letters; No change or gained 1 - 9 letters; Gained 10 - 14 letters; Gained 15 letters or more."|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719869|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
2719870|NCT01100307|Secondary|Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Weeks 24 to 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719871|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Open Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48 and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
2719872|NCT01100307|Secondary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719873|NCT01100307|Secondary|Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Up to 24 weeks|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719874|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Double Masked Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
2719875|NCT01100307|Primary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
2719876|NCT01100268|Secondary|Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.|Patients given Saving Inventory-Revised (SI-R), an evidence-based measure of three features of hoarding: excessive acquisition, difficulty discarding, and clutter. For the SI-R the minimum units are 0 and Maximum units on the total scale are 92. The higher the number on the SI-R, the more severe the symptoms. Response was defined as at least a 25% reduction on the SI-R.|4 weeks||||participants|||Number
2719877|NCT01100268|Primary|Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale|Patients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS.|4 weeks||||participants|||Number
2719892|NCT01100073|Secondary|Change From Baseline in UPDRS Part III Score at the End of Up-titration|Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part III scores available|||Points on a UPDRS scale||Standard Deviation|Mean
2719878|NCT01100255|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|1 week||||participants|||Number
2719879|NCT01100242|Secondary|Toxicity Profile|Toxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.|42 days||||participants|||Number
2719880|NCT01100242|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the percentage of patients who achieve a CR or PR|42 days||||percentage of participants|||Number
2719881|NCT01100242|Primary|Progression Free Survival (PFS)|Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 weeks||||weeks||Full Range|Median
2719882|NCT01100112|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8.~The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|8 weeks|All patients who received at least one dose of study drug.|||percentage of patients|||Number
2719883|NCT01100112|Secondary|Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.|Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.|Throughout the 8 week treatment period|All patients who received at least 1 dose of study drug.|||participants|||Number
2719884|NCT01100112|Secondary|The Secondary Efficacy Endpoint is Clinical Improvement|The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of > or = 3 points from baseline.|After 8 weeks treatment period|All patients who received at least 1 dose of study drug.|||percentage of patients|||Number
2719885|NCT01100112|Primary|The Percentage of Patients Achieving Clinical Remission|"The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of < or = 1 with a score of 0 for both rectal bleeding and stool frequency, and > or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance).~The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum [worst] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = > 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|At the end of the 8 week treatment period|All patients who received at least 1 dose of study drug.|||percentage of patients|||Number
2719886|NCT01100086|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719887|NCT01100086|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719888|NCT01100086|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719889|NCT01100073|Secondary|Number of Premature Discontinuations|Number of patients discontinuing the study prematurely|Week 0 to weeks 9-16 (end of study)|Total patients|||Participants|||Number
2719890|NCT01100073|Secondary|Incidence, Relationship and Seriousness of Adverse Events|Total number of adverse events (AEs), causality and level of seriousness|Week 0 to weeks 9-16 (end of study)|Total patients|||Number of events|||Number
2719891|NCT01100073|Secondary|Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration|Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II and III scores available|||Points on a UPDRS scale||Standard Deviation|Mean
2719923|NCT01099761|Secondary|Percent Change in Total Lean Body Mass by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.||||percentage change in lean body mass||Standard Error|Mean
2719893|NCT01100073|Secondary|Change From Baseline in UPDRS Part II Score at the End of Up-titration|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II scores available|||Points on a UPDRS scale||Standard Deviation|Mean
2719894|NCT01100073|Secondary|Final Dose Distribution|Final Mirapexin® dose distribution at the end of study|Enter Week 0 to weeks 9-16 (Visit 3)|Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.|||milligrams of Mirapexin® (salt)||Full Range|Median
2719895|NCT01100073|Primary|Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance|Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available|||unit on a scale||Standard Deviation|Mean
2719896|NCT01100073|Primary|Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)|Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available|||Points on UPDRS scale||Standard Deviation|Mean
2719897|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the left hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available|||millimeters of tremor amplitude||Standard Deviation|Mean
2719898|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the right hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available|||millimeters of tremor amplitude||Standard Deviation|Mean
2719899|NCT01100073|Primary|Change From Baseline in UPDRS Part III Score at the End of Maintenance|Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Week 0 to weeks 9-16|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available|||Points on UPDRS scale||Standard Deviation|Mean
2719900|NCT01100073|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available|||Points on UPDRS scale||Standard Deviation|Mean
2719901|NCT01100034|Secondary|Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period||Week 24 up to Week 216|"Analysis population included all enrolled participants who were documented as having received at least 1 dose of etanercept. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||weeks||Standard Deviation|Mean
2719902|NCT01100034|Primary|Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants|Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported.|Week 24 up to Week 216|"Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and “Number Analyzed” signifies the participants evaluable at specific rows."|||percentage of participants|||Number
2719903|NCT01100034|Primary|Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants|Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.|Week 24 up to Week 216|"Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2719904|NCT01100034|Primary|Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants|Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.|Baseline up to 24 weeks|Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only.|||Participants|||Count of Participants
2719905|NCT01100034|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 28 days after last dose of study drug (up to 61 months)|Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only.|||Participants|||Count of Participants
2719924|NCT01099761|Primary|Number of Subjects With Clinical Laboratory Adverse Reactions.|Number of subjects in each cohort with treatment-emergent adverse laboratory values judged to be at least possibly related to study drug|Baseline to End-of-Study Visit, approximately 24 weeks later.||||Number of subjects|||Number
2719906|NCT01100034|Primary|Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants|Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus.|Baseline up to 5 years|Prospective Participants: participants who started etanercept within 30 days before the enrollment date or any time after enrollment date. This outcome measure was planned to be analyzed in prospective participants only.|||Participants|||Count of Participants
2719907|NCT01099969|Secondary|Cormack and Lehane Grade of Laryngeal View|The Comarck Lehane classification is as follows: 1)Full view of glottis; 2a) Partial view of glottis; 2b) Only posterior extremity of glottis seen or only arytenoid cartilages; 3) only epiglottis is seen, none of glottis seen; 4) neither glottis nor epiglottis seen.|at the time of intubation||||Participants|||Count of Participants
2719908|NCT01099969|Primary|Number of Difficult Intubations|"Ease of intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = extremely difficult). A score of 4 or 5 was characterized as difficult."|at the time of placement of the endotracheal tube||||intubations|||Number
2719909|NCT01099969|Primary|Number of Intubation Attempts||at the time of placement of the endotracheal tube||||Participants|||Count of Participants
2719910|NCT01099969|Primary|Intubation Time|Intubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.|time from insertion of the laryngoscope to detection of CO2 on the capnogram||||seconds||Standard Deviation|Mean
2719911|NCT01099917|Primary|Changes in Neutrophil Counts|The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients|baseline and week 12||||cells/mm^3||95% Confidence Interval|Mean
2719912|NCT01099774|Primary|Average Eye IOP at Week 2|Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 2|Intent to Treat Population: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2719913|NCT01099774|Primary|Average Eye IOP at Week 6|Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 6|Intent to Treat Population: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2719914|NCT01099774|Primary|Average Eye IOP at Week 12|Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.|Baseline, Week 12|Intent to Treat Population: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2719915|NCT01099774|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12|Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.|Baseline, Week 12|Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2719916|NCT01099761|Secondary|Change in Pulmonary Function Test (MEP)|Maximum Expiratory Pressure (MEP); 3 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Stuidy Visit, approximately 24 weeks||||cm H2O||Standard Deviation|Mean
2719917|NCT01099761|Secondary|Change in Pulmonary Function Test (MIP)|Maximum Inspiratory Pressure (MIP); 2 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit. approximately 24 weeks||||cm H2O||Standard Deviation|Mean
2719918|NCT01099761|Secondary|Change in Pulmonary Function Tests (FVC)|Forced Vital Capacity (FVC); 1 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit, approximately 24 weeks later.||||Liters||Standard Deviation|Mean
2719919|NCT01099761|Secondary|Change From Baseline in Time to Travel 10 Meters (Standardized 10-Meter-Walk/Run Test).||Baseline to End-of-Study Visit, approximately 24 weeks later.||||Change (sec) in 10MWT from baseline||Standard Deviation|Mean
2719920|NCT01099761|Secondary|Change in Distance Traveled in 6 Minutes (Standardized 6-Minute-Walk Test).|Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test); stratified by baseline age (<10 years vs. >=10 years)|Baseline to End-of-Study Visit, approximately 24 weeks later.||||change (m) in 6MWT from baseline||Standard Deviation|Mean
2719921|NCT01099761|Secondary|Percent Change in Muscle Strength Score by Hand-held Myometry.|Manual Muscle Testing (MMT) is a procedure to measure the function and strength of individual muscles and muscle groups. Hand-held myometry, using a device known as a dynamometer, is one method used for MMT. The dynamometer is held against the patient's limb by the examiner and the patient is asked to resist the force applied by the examiner. The dynamometer measures the force applied by the patient, providing a quantitative and objective assessment of strength of the particular muscle or muscle group. The effectiveness of a therapeutic intervention on muscle strength, as measured by hand-held myometry, can be assessed by comparing post-treatment to pre-treatment (baseline) measurements.|Baseline to End-of-Study Visit, approximately 24 weeks later.||||percentage change from baseline||Standard Deviation|Mean
2719922|NCT01099761|Secondary|Percent Change in Lumbar Spine Bone Mineral Density by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.||||percentage change from baseline||Standard Error|Mean
2719926|NCT01099709|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719927|NCT01099709|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over a 72-hour time period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
2719928|NCT01099709|Primary|Cmax - Maximum Observed Plasma Concentration|Bioeqivalence based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
2719929|NCT01099618|Primary|Length of Remission|For those patients that are able to discontinue insulin therapy at or <12 weeks, how long were they able to well controlled with an A1c <7% on the agent that they were randomized to.|3 years||||days||Full Range|Median
2719930|NCT01099579|Secondary|Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir|Calculated as CLT/F divided by body weight|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||L/h per kilogram||Full Range|Geometric Mean
2719931|NCT01099579|Secondary|Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir|Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||L/h||Full Range|Geometric Mean
2719932|NCT01099579|Secondary|Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||Hours||Full Range|Median
2719933|NCT01099579|Secondary|Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||ng*h/mL||Full Range|Geometric Mean
2719934|NCT01099579|Secondary|Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||ng/mL||Full Range|Geometric Mean
2719935|NCT01099579|Secondary|Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir|Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.|After Day 1 to Week 48|Participants who met the criteria for virologic failure|||Participants|||Number
2719936|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder|||Percentage of lymphocytes||Standard Error|Mean
2719937|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder|||Percentage of lymphocytes||Standard Error|Mean
2719938|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder|||Cells/mm^3||Standard Error|Mean
2719939|NCT01099579|Primary|Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events|CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.|From Day 1 to Week 48||||Participants|||Number
2719940|NCT01099579|Primary|Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48|Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.|From Baseline to Week 48|All participants who received at least 1 dose of atazanavir and were evaluable|||Milliseconds||Standard Deviation|Mean
2719941|NCT01099579|Primary|Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4|ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.|After Day 1 to Week 48|All participants who received at least 1 dose of atazanavir; n=number of evaluable participants.|||Participants|||Number
2719942|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder|||Cells/mm^3||Standard Error|Mean
2719943|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had an HIV RNA measurement on ATV powder at Week 48|||Log10 c/mL||Standard Error|Mean
2719944|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight|Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48|From Baseline to Week 48|Participants who received at least 1 dose of atazanavir and who had HIV RNA while taking atazanavir powder at Week 48|||Log10 c/mL||Standard Error|Mean
2719945|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status|The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.|From Day 1 to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who did not switch to the ATV capsule formulation on or before Week 48|||Percentage of participants|||Number
2719946|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight|The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window. .|At Week 48|Participants who received at least 1 dose of atazanavir and who did not switch to the capsule formulation at or before Week 48|||Percentage of participants|||Number
2719947|NCT01099579|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 to Week 48|All participants who received at least 1 dose of active atazanavir powder.|||Participants|||Number
2719948|NCT01099475|Secondary|Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by ALAT level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3.|ALAT area under curve from start of surgery up until postoperative day 3||||IU*h/L||Standard Error|Mean
2719949|NCT01099475|Secondary|Amount of Blood Loss|amount of blood in the suction container (and, if applicable, in the weighted gauzes)|at the end of liver surgery, an average of 225 minutes||||mL||Full Range|Median
2719950|NCT01099475|Secondary|Post-resectional Complications|morbidity and mortality occuring after liver surgery graded according to Clavien-Dindo's grading system. In short, any deviation from the postoperative course without the need for pharmacological, radiological or surgical intervention was classified as Clavien-Dindo grade 1; complications requiring pharmacological treatment were graded as grade 2; complications requiring surgical or radiological intervention not under general anesthesia as grade 3a and under general anesthesia as grade 3b; grade 4 complications were life-threatening complications requiring intensive care unit care because of single organ dysfunction (grade 4a) or multiple organ dysfunction (grade 4b); mortality was classed as grade 5.|within 90-days after initial liver surgery||||participants|||Number
2719951|NCT01099475|Primary|Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by L-FABP) level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3. This continuous variable with repeated measurements was summarized as area under the curve (AUC) from baseline to postoperative day 3 (as described in Matthews JN, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. Bmj 1990;300:230-5).|L-FABP area under curve from start of surgery up until postoperative day 3||||ng*h/mL||Standard Error|Mean
2719952|NCT01099449|Secondary|Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire|This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received.|Up to 18 months|All patients that had at least one cycle of treatment and submitted a patient-reported quality of life (QOL) as measured by the supplemental QOL questionnaire|||score on a scale||Standard Deviation|Mean
2719953|NCT01099449|Secondary|Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0||Up to 18 months||||Number of reported Adverse Events|||Number
2719954|NCT01099449|Secondary|Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin|This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a > repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be.|Up to 18 months||||percentage of patients|||Number
2719955|NCT01099449|Secondary|Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity||Up to 18 months|All patients that received treatment.|||percentage of patients|||Number
2719956|NCT01099449|Secondary|Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity|A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity.|Up to 18 months|All patients that discontinued treatment.|||Doses||Standard Deviation|Mean
2719957|NCT01099449|Secondary|Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy|Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.|Up to 18 months||||Days||Inter-Quartile Range|Median
2719958|NCT01099449|Secondary|Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity.|Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event.|Up to 18 months|All patients that under went at least one cycle of treatment and were analyzed for chronic cumulative neurotoxicity (NCI CTCAE version 4.0 and oxaliplatin-specific neurotoxicity scale) during and after chemotherapy|||percentage of patients|||Number
2719959|NCT01099449|Secondary|Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores|The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.|Up to 18 Months|All patients with at least baseline and more than 1 cycle of Motor Neuropathy data.|||AUC QLQ-CIPN20 Motor Neuropathy Score||Standard Deviation|Mean
2719960|NCT01099449|Secondary|Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores|The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.|Up to 18 months|All patients with Baseline and more than one cycle of EORTC CIPN-20 Autonomic data.|||score on a scale||Standard Deviation|Mean
2719961|NCT01099449|Primary|Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy|The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received.|Up to 18 months|All enrolled patients with Baseline and more than 1 cycle of Sensory data.|||score on a scale||Standard Deviation|Mean
2719962|NCT01099397|Primary|Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment|A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.|Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)|Only including participants with data at each time point|||participants|||Number
2719963|NCT01099358|Primary|Cetuximab Pharmacokinetics: Confirmatory Serum Concentration||Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2719994|NCT01098851|Primary|Number of Participants Requiring Airway Support|Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.|3 hours||||Participants|||Number
2719964|NCT01099358|Primary|Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.|||Hours (h)||Full Range|Median
2719965|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.|||Hours (h)||Full Range|Median
2719966|NCT01099358|Primary|Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2719967|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.|||micrograms/milliliters(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2719968|NCT01099358|Primary|Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B or C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.|||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2719969|NCT01099358|Primary|Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.|||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2719970|NCT01099267|Primary|Cause of Death for Participants Who Died|Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.|up to 7 years|Safety population of participants who died|||participants|||Number
2719971|NCT01099267|Primary|Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)|Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.|||months||95% Confidence Interval|Median
2719972|NCT01099267|Primary|Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up|Count of participants who progressed to AML at the time of the extension study follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.|||participants|||Number
2719973|NCT01099267|Primary|Kaplan Meier Estimate for Overall Survival|Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population|||months||95% Confidence Interval|Median
2719974|NCT01099267|Primary|Participants Survival Status as of the Time of the Extension Study Follow-up|Count of participants who were alive or deceased at the time of the extension study follow-up.|up to 7 years|Intent to treat population|||participants|||Number
2719975|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 48 weeks|Intention-to-Treat Population Analysis|||participants|||Number
2719976|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 24 weeks|Intention-to-Treat Population Analysis|||participants|||Number
2719977|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 4 weeks|Intention-to-Treat Population Analysis|||participants|||Number
2719978|NCT01099215|Secondary|Changes in Physical Exam|Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported|within 4, 24 and 48 weeks from baseline|Safety Population Analysis|||participants|||Number
2719979|NCT01099215|Secondary|Resting Ankle-brachial Index|ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.|within 4, 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis|||ratio||Standard Deviation|Mean
2719981|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50-99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
2719982|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50-99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
2719983|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50-99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
2719984|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
2719985|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
2719986|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
2719987|NCT01099215|Secondary|Incidence of Adverse Events, Laboratory Abnormalities||Up to 48 weeks from study procedure|Safety Population Analysis|||participants|||Number
2719988|NCT01099215|Secondary|Incidence of Serious Adverse Events||Up to 48 weeks from study procedure|Intention-to-Treat Population Analysis|||participants|||Number
2719989|NCT01099215|Secondary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:~Death~Major amputation~Procedural related serious adverse events~Investigational product related serious adverse events"|within 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis|||participants|||Number
2719990|NCT01099215|Primary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:~Death~Major amputation~Procedural related serious adverse events~Investigational product related serious adverse events"|within 4 weeks after study procedure|Intention-to-Treat Population Analysis|||participants|||Number
2719991|NCT01099202|Primary|Number of PRBC Transfusions During Initial 5 Months of Treatment|Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.|||transfusions||Standard Deviation|Mean
2719992|NCT01099202|Primary|Mean Number of RBC Units Transfused During Initial 5 Months of Treatment|Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.|||PRBC Units||Standard Deviation|Mean
2719993|NCT01099111|Primary|Colonic-Mucosa Associated Microbial Species Per Compiled Participants in 5 Different Arms|"The entire mucosal microbial community were profiled using high-throughput DNA sequencing and microarray technology. The microarray approach is based on 16S rRNA gene targeted oligonucleotide allowing the rapid detection of thousands of DNA sequences simultaneously and thus constitutes an ideal tool to generate a comprehensive and holistic view of the gut microbial community in all participants of all study arms.~Then they will be analysed between different colonic segments in each participant, pooled results of participants in each of the 5 arms will be compared to the measurable outcomes of other arms in general."|1 - 2 weeks|Each participant colonic mucosal microbiota populations pattern were analysed, and then compared to control to look for specific enrichments. If the DNA extract was not enough for sequencing, then the participant sample was excluded, however analysis calculation was based on all enrolled participants. The number analyzed here represent all enrolled|||microbial species population||95% Confidence Interval|Number
2719995|NCT01098851|Primary|Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow|Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.|3 hours||||Participants|||Number
2719996|NCT01098812|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant|Available subjects at the final visit with measured uncorrected distance visual acuity.|||LogMAR acuity values||Standard Deviation|Mean
2719997|NCT01098812|Primary|Mean Percent Reduction in Cylinder|Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant compared to baseline|Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder.|||percentage of reduction in cylinder||Standard Deviation|Mean
2719998|NCT01098747|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2719999|NCT01098747|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2720000|NCT01098747|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2720001|NCT01098747|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Hours||95% Confidence Interval|Median
2720002|NCT01098747|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2720003|NCT01098747|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2720004|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720005|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720006|NCT01098747|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720182|NCT01098071|Secondary|Severity of Rhinorrhea at Baseline and Week 12|Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
2720007|NCT01098747|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720008|NCT01098747|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720009|NCT01098747|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720010|NCT01098747|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
2720011|NCT01098747|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
2720012|NCT01098747|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 8 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2720013|NCT01098578|Other Pre-specified|Total Institutional Cost Savings|Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery|End of study. Cost calculated after 20 patients were treated with Floseal||||US Dollars|||Number
2720014|NCT01098578|Secondary|Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.|The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40%|30 days||||percentage of expected cost|||Number
2720015|NCT01098578|Primary|Effectiveness of Floseal for the Treatment of Posterior Epistaxis.|Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date.|Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.||||participants|||Number
2720016|NCT01098539|Secondary|Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16|Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.|Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)|ITT population. Only participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2720017|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 52: OC|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Kilograms||Standard Deviation|Mean
2720018|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Kilograms||Standard Deviation|Mean
2720019|NCT01098539|Secondary|Change From Baseline in Body Weight at Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
2720020|NCT01098539|Secondary|Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|Week 2 to Week 52|ITT Population|||Weeks||95% Confidence Interval|Median
2720021|NCT01098539|Secondary|Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.|Week 2 to Week 52|ITT Population|||Participants|||Number
2720022|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
2720023|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC|The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
2720024|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
2720025|NCT01098539|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF|The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
2720026|NCT01098539|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2720027|NCT01098539|Secondary|Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2720028|NCT01098539|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2720029|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2720030|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, and 20|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2720031|NCT01098539|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 26|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2720032|NCT01098500|Secondary|Median Time to the Maximum BIL Elevation During Follow-up|Median time (in months) between index date and date of maximum BIL elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.|||months||Full Range|Median
2720033|NCT01098500|Secondary|Maximum BIL Elevation Reached During Follow-up|Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.|||participants|||Number
2720034|NCT01098500|Secondary|Median Time to the Maximum ALP Elevation During Follow-up|Median time (in months) between index date and date of maximum ALP elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.|||months||Full Range|Median
2720035|NCT01098500|Secondary|Maximum ALP Elevation Reached During Follow-up|Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.|||participants|||Number
2720036|NCT01098500|Secondary|Median Time to the Maximum AST Elevation During Follow-up|Median time (in months) between index date and date of maximum AST elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.|||months||Full Range|Median
2720037|NCT01098500|Secondary|Maximum AST Elevation Reached During Follow-up|Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.|||participants|||Number
2720038|NCT01098500|Secondary|Median Time to the Maximum ALT Elevation During Follow-up|Median time (in months) between index date and the date of maximum ALT elevation.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.|||months||Full Range|Median
2720039|NCT01098500|Secondary|Maximum ALT Elevation Reached During Follow-up|Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.|||participants|||Number
2720040|NCT01098500|Primary|Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)|Number of patients with Hy's Law (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).|||participants|||Number
2720041|NCT01098500|Primary|Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)|Prevalence of patients with Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).|||participants|||Number
2720042|NCT01098500|Primary|Incidence of ALT >=3x ULN|Number of patients with ALT >=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)|||participants|||Number
2720043|NCT01098500|Primary|Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)|Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.|||participants|||Number
2720044|NCT01098487|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy|On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; >1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; >30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population|||Participants|||Number
2720053|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Twelve Months post Dose 3 [PIII(M14)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720183|NCT01098071|Primary|Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy||Baseline to 12 weeks|Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)|||Participants|||Number
2720045|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study|Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population|||Participants|||Number
2720046|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population|||Participants|||Number
2720047|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 2 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
2720048|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 1 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
2720049|NCT01098487|Primary|Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
2720050|NCT01098487|Primary|Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
2720051|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at Baseline|The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
2720052|NCT01098487|Primary|Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline|The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis [MF]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
2720109|NCT01098474|Primary|Number of Subjects With Grade 3 Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|From Day 0 to Day 29|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2720054|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Twelve Months post Dose 2 [PII(M13)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720055|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Twelve Months post Dose 1 [PI(M12)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720056|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Six Months post Dose 3 [PIII(M13)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720057|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Six Months post Dose 3 [PIII(M8)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720058|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Six Months post Dose 2 [PII(M7)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720059|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were : normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Six Months post Dose 1 [PI(M6)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720060|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|One Month post Dose 3 [PIII(M3)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720061|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|One Month post Dose 2 [PII(M2)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720062|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|One Month post Dose 1 [PI(M1)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720063|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Seven days post Dose 3 [PIII(D67)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720064|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Seven days post Dose 2 [PII(D37)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720065|NCT01098474|Secondary|Number of Subjects With Normal, G1, G2, or G4 Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were : normal, grade 1 (G1), grade 2 (G2) and grade 4 (G4). Values that did not fall under normal levels or assessed grades were missing.|Seven days post Dose 1 [PI(D7)]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2720066|NCT01098474|Secondary|Number of Subjects With Normal, Grade 1 (G1), Grade 2 (G2) or Grade 4 (G4) Haematological and Biochemical Markers|Levels assessed for Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA) were: normal, G1, G2 and G4 . Values that did not fall under normal levels or assessed grades were missing.|Before vaccination (PRE)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2720067|NCT01098474|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to 12 months post last vaccination|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2720068|NCT01098474|Secondary|Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F Antibody Concentrations|Concentrations, given in µg/mL, were expressed as Geometric Mean Concentrations (GMCs).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2720069|NCT01098474|Secondary|Number of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.2 Microgram/Milliliter|A seroconverted subject is a vaccinated subject with at least a four fold increased antibody titer post vaccination.|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720070|NCT01098474|Secondary|Number of Seropositive Subjects Against Streptococcus Pneumoniae (Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-18C, Anti-19F, Anti-23F)|A seropositive subject was a subject whose anti-S pneumoniae antibody concentration was ≥ 0.05 µg/mL.|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720071|NCT01098474|Secondary|Anti-Polio1, Anti-Polio2, Anti-Polio3 Antibody Titers|Concentrations given in titers were expressed as Geometric Mean Titers (GMTs).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2720072|NCT01098474|Secondary|Number of Seropositive Subjects Against Polio (Anti-Polio1, Anti-Polio2, Anti-Polio3)|A seropositive subject was a subject whose anti-polio antibody titer was ≥ 1:8.|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720073|NCT01098474|Secondary|Anti-HB Antibody Concentrations|Concentrations given in mIU/mL were expressed as Geometric Mean Concentrations (GMCs).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2720074|NCT01098474|Secondary|Number of Seropositive Subjects Against Hepatitis B (Anti-HB) With Antibody Concentrations ≥100mIU/mL|A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Following from this, the table shows data with titers ≥ 100 mIU/mL.|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720075|NCT01098474|Secondary|Number of Seropositive Subjects Against Hepatitis B (Anti-HB)|A seropositive subject was a subject whose anti-HB antibody concentration was ≥ 10 milli-international units per millilitre (mIU/mL).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720076|NCT01098474|Secondary|Anti-BPT Antibody Concentrations|Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2720077|NCT01098474|Secondary|Number of Seropositive Subjects Against Bordetella Pertussis (Anti-BPT)|A seropositive subject was a subject whose anti-BPT antibody concentration was ≥ 15 EL.U/mL.|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720078|NCT01098474|Secondary|Anti-PRP Antibody Concentrations|Concentrations given in µg/mL were expressed as Geometric Mean Concentrations (GMCs).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2720079|NCT01098474|Secondary|Number of Seroprotected Subjects Against Haemophilus Influenzae Type B (Anti-PRP)|A seroprotected subject was a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per millilitre (µg/mL).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720080|NCT01098474|Secondary|Anti-D, Anti-T Antibody Concentrations|Concentrations given in IU/mL, were expressed as Geometric Mean Concentrations (GMCs).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2720081|NCT01098474|Secondary|Number of Seroprotected Subjects Against Diphtheria Toxoid (Anti-D) and Tetanus Toxoid (Anti-T)|A seroprotected subject was a subject whose anti-diphtheria toxoid (anti-D)/anti-tetanus toxoid (anti-T) antibody concentration was ≥ 0.1 international-units per millilitre (IU/mL).|Before vaccination (PRE) and 1 Month post Dose 3 [PIII(M3)]|The analysis was performed on those groups from the ATP cohort for analysis of immunogenicity that also contained Tritanrix™ HepB+Hiberix™, Prevnar® and Polio Sabin™ vaccines in their vaccination regimen, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720082|NCT01098474|Secondary|Concentration of Antibodies Against M72 Antigen|Concentrations given in EL.U/mL were expressed as Geometric Mean Concentrations (GMCs).|Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2720083|NCT01098474|Secondary|Number of Seropositive Subjects Against M72 Antigen|A seropositive subject was a subject whose M72 antibody concentration was greater than or equal to 2.8 ELISA units per millilitre (EL.U/mL).|Before vaccination (PRE) and after each dose [at 1, 6 and 12 months post-vaccination (M1, M6 and M12)]|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2720084|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Twelve Months after each dose (M12)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720085|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Six Months after each dose (M6)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720086|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|One Month after each dose (M1)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720097|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 12|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720087|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Seven Days after each dose (D7)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720088|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)8+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Before vaccination (PRE)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720089|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Twelve Months post each dose (M12)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720090|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Six Months post each dose (M6)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720091|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|One Month post each dose (M1)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720092|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2) and/or Interferon-gamma (INF-γ) and/or Tumour necrosis factor-alpha (TNF-α) and/or CD40-ligand (CD40-L).|Seven Days post each dose (D7)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720093|NCT01098474|Secondary|Frequency of M. Tuberculosis Fusion Protein M72 (M72)-Specific Cluster of Differentiation (CD)4+ T Cells Per Million Cells Expressing at Least Two Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2),Interferon-gamma (INF-γ),Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).|Before vaccination (PRE)|The analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study), for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2720094|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 8|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720095|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 14|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720096|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|Twelve Months post Dose 2 [At Month 13]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720098|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|Six Months post Dose 3 [At Month 13]|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720099|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 7|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720100|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA).Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 6|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720101|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 3|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720102|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 2|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720103|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Month 1|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720104|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Day 67|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720105|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Day 37|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720106|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 g/dL; WBC.: 1.0 to 1.4 x 10³/µL; PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x ULN and CREA: 3.1 to 6.0 x ULN.|At Day 7|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. Arms were presented separately due to the different timepoints used for reporting the results.|||Participants|||Count of Participants
2720107|NCT01098474|Primary|Number of Subjects With Grade 3 Haematological and Biochemical Levels|Haematological/Biochemical parameters assessed were: Haemoglobin (Haem), White Blood Cells (WBC), Platelets (PLA), Alanine Aminotransferase (ALA) and Creatinine (CREA). Grade 3 = Haem.: < 5.0 grams per deciliter (g/dL); WBC.: 1.0 to 1.4 x 10³/micro liter (µL); PLA.: < 25x10³/µL; ALA.: 5.1 to 10.0 x upper limit of normal (ULN) and CREA: 3.1 to 6.0 x ULN.|At Day 0|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2720108|NCT01098474|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 17|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2720221|NCT01097707|Secondary|Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)|The units of PSA measurement are nanograms per milliliter (ng/mL).|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline PSA measurement.|||percentage change in PSA||Standard Deviation|Mean
2720110|NCT01098474|Primary|Number of Subjects With Grade 3 Solicited General Symptoms After Dose 2, Dose 3 and Across Doses.|Solicited general symptoms were only collected after Dose 2 of EPI vaccination. Solicited general symptoms assessed were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C.|From Day 0 to Day 6|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.|||Participants|||Count of Participants
2720111|NCT01098474|Primary|Number of Subjects With Grade 3 Solicited General Symptoms After Dose 1, Dose 2 and Across Doses.|Solicited general symptoms assessed were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C.|From Day 0 to Day 6|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.|||Participants|||Count of Participants
2720112|NCT01098474|Primary|Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 2, Dose 3 and Across Doses.|Solicited local symptoms were only collected after Dose 2 of EPI vaccination. Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|From Day 0 to Day 6|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.|||Participants|||Count of Participants
2720113|NCT01098474|Primary|Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses|Solicited local symptoms assessed were pain, redness and swelling. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|From Day 0 to Day 6|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available. As the outcome was defined differently according to the doses received by the subjects in each group, it is presented separately.|||Participants|||Count of Participants
2720114|NCT01098461|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK/PD Analysis Pop: all participants in the PK Analysis Pop with sufficient dosing history for inclusion in the PK/PD analysis. Modeled population PK data (analyzed using a non-linear mixed effect modeling approach) are presented. A one-compartment PK model with first-order absorption/elimination processes was selected to describe GSK716155 PK.|||nanograms per milliliter||95% Confidence Interval|Mean
2720115|NCT01098461|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population (Pop)|||hour^-1||95% Confidence Interval|Mean
2720116|NCT01098461|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population|||Liters||95% Confidence Interval|Mean
2720127|NCT01098318|Secondary|The Clinical Global Impression (CGI) Severity and Change|"A clinician-rated measure of global symptom severity (CGI/S) and symptom change (CGI/C) of MDD. Severity was rated as Not ill; Borderline ill; Mild; Moderate; Moderately severe; Severe and Extremely severe. Global change was rates as Very much improved; Much improved; Minimally improved; Unchanged;Minimally worse;Much worse and Very much worse. Here in severity, we reported the N(%) of subjects who were not ill or borderline ill. In change, we reported N(%) of subjects who were Very much improved or Much imp[roved.Subjects started the study with mild to moderate MDD (moderate or above rating in the CGI-S). At WK12, the #/% of subjects in each treatment group who were not ill at WK12 (CGI-S) and who had much improved or very much improved at WK12 (CGI-C) was reported."|12 weeks||||Participants|||Count of Participants
2720117|NCT01098461|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed|||milliliters per hour||95% Confidence Interval|Mean
2720118|NCT01098461|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.|Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Participants|||Number
2720119|NCT01098461|Secondary|Change From Baseline in Body Weight at Week 4, 8, 12, and 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Kilograms||Standard Deviation|Mean
2720120|NCT01098461|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2720121|NCT01098461|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2720122|NCT01098461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomized participants with at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2720123|NCT01098318|Secondary|Number of Participants With Treatment Emergent Side Effects||12 weeks|All enrolled subjects were analyzed|||Participants|||Count of Participants
2720124|NCT01098318|Secondary|Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form|Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12.|12 weeks|All enrolled subjects were analyzed|||Participants|||Count of Participants
2720125|NCT01098318|Secondary|Change in Sexual Function|This is a patient completed rating of sexual function and satisfaction. It is used to assess current sexual health and changes in sexual health over time measured by the overall sexual satisfaction score. The reported score is the overall degree of sexual satisfaction attained. The score ranges from 0 to 100. Higher score indicates more sexual satisfaction.|12 weeks|All enrolled subjects were analyzed|||scores on a scale||Inter-Quartile Range|Median
2720126|NCT01098318|Secondary|Change in Depressive Symptoms as Measured by the Beck Depression Inventory|All enrolled subjects were analyzed. Mean change in Beck Depression Inventory (BDI) total scores were reported. BDI is a self-reported outcome measuring the severity of depression. A negative # means a reduction in BDI score at the end of treatment compared to baseline which represents an improvement in depression symptoms. BDI total score ranges from 0-63. BDI score of 1-16 represents low level of depression;17-30 represents moderate level of depression; >=31 represents significant level of depression. A reduction in the BDI score represents improvement in the depression symptoms.|12 weeks||||scores on a scale||Standard Deviation|Mean
2721545|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2720128|NCT01098318|Primary|Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.|Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom.|12 weeks||||units on a scale||Standard Deviation|Mean
2720129|NCT01098305|Secondary|Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.|Side Effects|Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)||||participants|||Number
2720130|NCT01098305|Primary|7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.||At the end of treatment (12 weeks)||||participants|||Number
2720131|NCT01098266|Secondary|Evaluation of Medical Care Utilization in the Two Treatment Arms|Medical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.|Assessed every 6-12 weeks, up to 100 weeks||||Participants|||Count of Participants
2720132|NCT01098266|Secondary|Time to LCSS Symptomatic Progression|Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.|from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)|Participants with a worsening in the average symptom burden index by 25%.|||months||95% Confidence Interval|Median
2720133|NCT01098266|Secondary|Number of Partecipants With Adverse Events|All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.|Assessed every 6-12 weeks, up to 100 weeks|The safety data referred to patients of both arms who received at least one treatment and is termed as safety population (n=386)|||participants|||Number
2720134|NCT01098266|Secondary|Number of Partecipants With Disease Control for ≥ 6 Months|Measured from the date of randomization until disease progression, or death due to any cause|Assessed every 6-12 weeks, up to 100 weeks|Duration of disease control ≥ 6 months|||Participants|||Count of Participants
2720135|NCT01098266|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria|Assessed every 6-12 weeks, up to 100 weeks||||Participants|||Count of Participants
2720136|NCT01098266|Secondary|Progression-Free Survival (PFS)|Defined as the time from the date of randomization until disease progression, or deathdue to any couse or the last patient was konwn to be alive. Progression is defined usind Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition torelative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. In addition the appearance of one or more new lesions was also considered progression|From the date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assessed up to 48 months||||months||95% Confidence Interval|Median
2720137|NCT01098266|Primary|Overall Survival (OS)|Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive|From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months||||months||95% Confidence Interval|Median
2720138|NCT01098253|Secondary|Nine Item Patient Health Questionnaire (PHQ-9)|Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9). PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).|||Percentage of participants with PHQ-9 <5|||Number
2720139|NCT01098253|Primary|Hemoglobin A1C|HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).|||Percentage of participants with HbA1c <7|||Number
2720140|NCT01098240|Other Pre-specified|The Sheehan Suicidality Tracking Scale (STS)|The Sheehan Suicidality Tracking Scale (STS) measures treatment-emergent suicidal ideation as well as behaviors. It can be administered by a clinician or filled in by a participant. Prior to analysis, the STS was mapped to the Columbia Classification Algorithm of Suicide Assessment(C-CASA) categories, which has 9-item including completed suicide, suicide attempt, preparatory acts, suicidal ideation, self-injurious behavior, self-injurious no intent, unknown fatal,unknown non-fatal or other not deliberate. Participants who were mapped to C-CASA items were reported.|Week 8 (double-blind baseline) and weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Participants|||Number
2720179|NCT01098071|Secondary|Severity of Sneezing at Baseline and Week 12|Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
2720141|NCT01098240|Secondary|Plasma CP-601,927 Concentration|Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.|Week 11, 12 and 14|All randomized participants with at least one dose of study medication in DB (double blind) phase and one valid plasma concentration measurement collected during the DB phase was be included in the analyses of the PK endpoints. n = number of participants with evaluable data at each timeframe.|||ng/mL||Standard Deviation|Mean
2720142|NCT01098240|Secondary|Population Pharmacokinetics|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations|Weeks 11,12 and 14|||||||
2720143|NCT01098240|Secondary|Number of Participants With Response at Weeks 9 Through 14|Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.|Weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Participants|||Number
2720144|NCT01098240|Secondary|Number of Participants With Remission at Weeks 9, 10, 12 and 14|Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 ('much' or 'very much' improved).|Weeks 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Participants|||Number
2720145|NCT01098240|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14|CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 8 (double-blind baseline) 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720146|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14|SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720147|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14|SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720148|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14|The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720149|NCT01098240|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14|CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 8 (double-blind baseline) and weeks 9, 10, 12, 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720150|NCT01098240|Secondary|Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14|The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720151|NCT01098240|Secondary|Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14|The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720152|NCT01098240|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline) and weeks 9 through 13|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720153|NCT01098240|Primary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
2720154|NCT01098162|Secondary|Incidence of Adverse Events During the Study|The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.|From Inclusion Visit (Day 0) up to Month 6|"All 571 subjects in the Safety Set are included in the analysis of this outcome measure.~Safety Set comprises all patients included who have been treated with Vimpat® at least once."|||participants|||Number
2720155|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.~Change in number of partial-onset seizures with secondary generalization was derived as follows:~Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.~Partial-onset seizures with secondary generalization can be classified into one of the following three groups:~Simple partial seizures evolving to generalized seizures~Complex partial seizures evolving to generalized seizures~Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
2720156|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.~Change in number of partial-onset seizures with secondary generalization was derived as follows:~Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.~Partial-onset seizures with secondary generalization can be classified into one of the following three groups:~Simple partial seizures evolving to generalized seizures~Complex partial seizures evolving to generalized seizures~Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 447 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
2720157|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.~Change in number of partial-onset seizures was derived as follows:~Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.~Partial-onset seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
2720158|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.~Change in number of partial-onset seizures was derived as follows:~Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.~Partial-onset seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 449 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
2720180|NCT01098071|Secondary|Severity of Nasal Itching at Baseline and Week 12|Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
2720159|NCT01098162|Primary|Clinical Global Impression of Change (CGI-C) at Month 6|"For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||participants|||Number
2720160|NCT01098110|Secondary|Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.|The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2720161|NCT01098110|Secondary|Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.|The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720162|NCT01098110|Secondary|Percentage of Participants Who Were PANSS Responders.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2720163|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720164|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720165|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720166|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score.|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720181|NCT01098071|Secondary|Severity of Nasal Congestion at Baseline and Week 12|Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
2720167|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score.|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720168|NCT01098110|Secondary|Change From Baseline in PANSS General Psychopathology Score.|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720169|NCT01098110|Secondary|Change From Baseline in PANSS Negative Symptom Score.|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720170|NCT01098110|Secondary|Change From Baseline in PANSS Positive Symptom Score.|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720171|NCT01098110|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2720172|NCT01098097|Secondary|Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)|Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.|Week 12|The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit|||percentage of participants||95% Confidence Interval|Number
2720173|NCT01098097|Primary|Incidence of Dose Modifications Due to Adverse Events|All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks||||percentage of participants|||Number
2720174|NCT01098097|Primary|Incidence of Particular Adverse Events Resulting in Treatment Discontinuation|"All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).~The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)"|Up to 12 Weeks||||percentage of participants|||Number
2720175|NCT01098097|Primary|Incidence of Treatment Discontinuations Due to Adverse Events|All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks||||percentage of participants|||Number
2720176|NCT01098097|Primary|Incidence of Thrombocytopenia|Thrombocytopenia is a low blood platelet count|Up to 12 Weeks||||percentage of participants|||Number
2720177|NCT01098097|Primary|Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.|Up to 12 Weeks||||percentage of participants|||Number
2720178|NCT01098071|Secondary|Severity of Eye Symptoms at Baseline and Week 12|Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
2721546|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2720184|NCT01098071|Primary|Degree of Posterior Choana Obstruction at Baseline and Week 12|The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.|Baseline and Week 12|Only participants that completed the study are included.|||Percent obstruction||Full Range|Mean
2720185|NCT01098071|Primary|Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score|Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).|Baseline and Week 12||||Score on a scale||Full Range|Mean
2720186|NCT01098032|Secondary|The Cost-effectiveness Ratio.|Assessement of the cost-effectiveness ratio is important when testing a new strategy of both therapy and prophylaxis. The Renalguard system is more expensive than the conventional hydration regimen. The cost of RenalGuard system is approximately 800 $. This cost will be justified only if the system is more effective in preventing CI-AKI and improving the clinical outcome, expecially reducing the lenght of ospedalization and the rate of dialysis.|1 month|||||||
2720187|NCT01098032|Secondary|The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema)|Assessment of the rate of in-hospital major adverse events (i.e. acute myocardial infarction, c) renal failure requiring dialysis, and d) acute pulmonary edema) will give important informantion on the clinical relevance of prophylactic strategies in preventing CI-AKI|1 month|||||||
2720188|NCT01098032|Secondary|the Rate of Acute Renal Failure Requiring Dialysis|occurrence of renal failure requiring dialysis represents the haard endpoint of the study. Actually this represents the worst clinical consequence of CI-AKI.|1 month|||||||
2720189|NCT01098032|Secondary|Changes in the Urine and Serum NGAL Concentration After Contrast Exposure|NGAL is a new biomarker which seems to be very promising in detecting kidney injury. prelimiary data suggest that urine and serum NGAL increase very early (within few horurs) after the occurrence og acute kidney damage. Therefore, NGAL may be a real marker of acute kidney injury.|7 days|||||||
2720190|NCT01098032|Secondary|Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure|Cystatin C is an alternative biomarker of kidney damage. Cystatin C seems to be superior to serum creatinine an identifying kidney function and damage.|7 days|||||||
2720191|NCT01098032|Secondary|Rate of Kidney Injury and Major Adverse Events|an increase in the serum creatinine concentration >=0.25% and >=0.5 mg/dl at 48 hours after contrast exposure|7 days|||||||
2720192|NCT01098032|Primary|Number of Participants With Contrast-induced Acute Kidney Injury|The primary outcome measure will be the rate of development of CI-AKI in the 2 study arms (number of participants). CI-AKI is defined as an increase in the serum creatinine concentration >=0.3 mg/dL from the baseline value at 48 hours after administration of the contrast media or the need for dialysis.|at 48 hours following contrast exposure|all consecutive patients with chronic kidney disease scheduled for coronary and/or peripheral angiography and/or angioplasty with an estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2 and/or a risk score ≥11 were considered eligible for the study|||participants|||Number
2720193|NCT01098006|Secondary|Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples|"The frequency was assessed based on the following range of markers: CD8, CD40L, IFNg, IL-2 and IL-17.~Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001)."|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720194|NCT01098006|Secondary|Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples|"The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.~Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001)."|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720195|NCT01098006|Secondary|Frequency of Cluster of Differentiation 8 (CD8+) Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples|"The frequency was assessed based on the following range of markers: CD8, CD40-L, IFNg, IL-2 and IL-17.~Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001)."|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720243|NCT01097694|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|Change in patient-reported Asthma Quality of Life Questionnaire (AQLQ) score The asthma quality of life questionnaire (AQLQ) is a 32-item scale with a range from 1-7 with a higher value denoting improvement. The minimal important difference is 0.5.|6 months after start of treatment||||units on a scale||Standard Deviation|Mean
2720196|NCT01098006|Secondary|Frequency of CD4+ Expressing CD40-L and/or Interferon-gamma (IFNg) and/or Interleukin 2 (IL-2) and/or IL-17 in Fresh Samples|"The frequency was assessed based on the following range of markers: CD4, CD40-L, IFNg, IL-2 and IL-17.~Note: The precision of the measure (i.e., four decimals) of median and inter-quartile range is not sufficient to distinguish between the values median, lower and upper limits of inter-quartile range for some of the data presented within the table below (e.g., median=0.0001 and inter-quartile range=0.0001 to 0.0001)."|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720197|NCT01098006|Primary|Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples|The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720198|NCT01098006|Primary|Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples|The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720199|NCT01098006|Primary|Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples|The frequency was assessed based on the following range of markers: CD4, CD69, LAP and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720200|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40|The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720201|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40|The frequency was assessed based on the following range of markers: CD4, CD45RA, CTLA4, OX40 and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720202|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2|The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720203|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or Tumor Necrosis Factor Receptor 2 (TNFR2)|The frequency was assessed based on the following range of markers: CD4, CD45RA, CD39, TNFR2 and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720204|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L|The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720205|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or, Chemokine (C-C Motif) Receptor 7 (CCR7) and/or CD62L|The frequency was assessed based on the following range of markers: CD4, CD45RA, CCR7, CD62L and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720206|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67|The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720207|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) and/or Proliferation Marker Ki67|The frequency was assessed based on the following range of markers: CD4, CD45RA, GITR, anti-Foxp3 and Ki67.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720208|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1|The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720209|NCT01098006|Primary|Frequency of Cluster of Differentiation 4 (CD4) + Forkhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1|The frequency was assessed based on the following range of markers: CD4, CD45RA, ICOS, HLA-DR, PD-1 and anti-Foxp3.|At the time of the visit for each subject (i.e., Day 0)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available, who had satisfied all specific criteria according to their specific group and with data available for the markers analyzed within this outcome measure.|||Treg cells/million cells||Inter-Quartile Range|Median
2720210|NCT01097915|Secondary|Taste Perception of Sweet, Sour, Salty, Bitter and Umami and Changes Due to L-Arginine Supplementation, as a Functin of Genetic Ability to Taste PROP.|Taste perception was assessed by testing the ability to recognize, and the responsiveness to, representative solutions of the five taste qualities, also when supplemented with L-Arg, in subjects classified as PROP-tasters.|8 months||||Participants|||Count of Participants
2720211|NCT01097915|Secondary|Association Between PROP Sensitivity and Fungiform Papilla Density|43 subjects were classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and density of fungiform papillae was determined in each subject.|6 months|Relationship between density of fungiform papillae and PROP taster status.|||No./cm2||Standard Error|Mean
2720212|NCT01097915|Secondary|Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity|electrophysiological recordings from the tongue of 43 subjects classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and genotyped for the specific receptor gene, TAS2R38. Density of fungiform papillae was also determined in each subject. The biopotentials were recorded by means of differential electrophysiological derivations between two silver electrodes, one in contact with the ventral surface of the tongue and one in perfect adhesion with the dorsal surface.|1 year|Relationship between depolarization amplitude of signals and PROP taster status.|||mV||Standard Error|Mean
2720213|NCT01097915|Secondary|Association Between PROP Sensitivity and BMI|Since individual ability to taste PROP may be correlated with BMI, we determined BMI (kg/m^2) in subjects classified as super-taster, medium taster and non-taster.Weight (kg) and height (m) were recorded for each subject.|7 months||||Kg/m^2||Standard Error|Mean
2720214|NCT01097915|Secondary|Association Between PROP Sensitivity and Saliva Zinc Ion Concentration|Since the enzymatic function of gustin (CA6) depends upon the presence of Zn at its active site we measured the salivary zinc ion concentration in subjects classified as super-taster, medium taster and non-taster.The salivary Zn2+ concentration was measured with a QuantiChromTM zinc Assay kit (Gentaur, Brussels, Belgium) where the color intensity is directly proportional to the Zn2+ concentration in the sample.|7 months||||microg/dl||Standard Error|Mean
2720215|NCT01097915|Primary|Association Between Gustin Gene Polymorphism and PROP Sensitivity|"We examine associations between PROP status and the polymorphism rs2274333 (A/G) of the gene that codify for the salivary protein, gustin/CA6, Which has been suggested as a trophic factor that promotes growth and development of taste buds by acting on taste bud stem cells.~The intensity of taste perception evoked by PROP and NaCl solutions was estimated to evaluate PROP taster status and molecular analysis of the gustin gene polymorphism was performed in individuals classified by PROP status using PCR techniques."|7 months||||percentage of participants|||Number
2720216|NCT01097863|Primary|Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.|"As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported."|1 week|Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).|||participants|||Number
2720217|NCT01097785|Secondary|Change in Measures of Reactive Oxygen Species in the Blood|Reactive Oxygen Species will be assessed after one month of placebo and statin therapy; measured using electron parametric resonance spectroscopy (EPR).|Baseline and 30 days||||EPR Arbitrary Units||Standard Error|Mean
2720218|NCT01097785|Primary|Change in Muscle Sympathetic Nerve Activity in Bursts Per 100 Heartbeats|Muscle sympathetic nerve activity will be assessed after one month of placebo and statin therapy; measured in bursts/100 heartbeats.|Baseline and 30 days||||bursts/100 heartbeats||Standard Error|Mean
2720219|NCT01097707|Secondary|Change From Baseline to 24-Week Endpoint in Lipid Profile|The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline lipid measurement.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2720220|NCT01097707|Secondary|Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone||Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline fasting total testosterone measurement.|||nanogram/deciliter (ng/dL)||Standard Deviation|Mean
2720302|NCT01097421|Secondary|Adverse Events (AE) Considered Related to Observed Medication|Some patients had not related AEs as well as related AEs.|8-12 weeks|Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation.|||Patients|||Number
2720222|NCT01097707|Secondary|Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores|IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with a total subscore of the 3 questions for irritative subscore ranging from 0 to 15. IPSS Voiding (Obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with a total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Nocturia Subscore is IPSS Question 7, which assesses how many times over the last month a participant gets up to urinate from the time they went to bed at night until the time they got up in the morning. Scores range from 0=None; 1=1 time; 2= 2 times; 3=3 times; 4=4 times; 5=5 or more times.|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline IPSS subscores measurement.|||units on a scale||Standard Deviation|Mean
2720223|NCT01097707|Secondary|Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)|"IPSS QoL assesses participant's response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0), Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6."|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline IPSS-QoL measurement.|||units on a scale||Standard Deviation|Mean
2720224|NCT01097707|Secondary|Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)|Qmax is defined as the peak urine flow rate measured using standard calibrated uroflowmeter.|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline Qmax measurement.|||milliliters/second (mL/sec)||Standard Deviation|Mean
2720225|NCT01097707|Secondary|Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)|The TPV measurement (milliliters) by transrectal ultrasound (TRUS) is an established diagnostic test for men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline TPV measurement.|||percentage change in TPV||Standard Deviation|Mean
2720226|NCT01097707|Primary|Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 24 weeks|All randomized participants who had baseline and one post-baseline IPSS total score measurement.|||units on a scale||Standard Deviation|Mean
2720227|NCT01097694|Secondary|Change in Number of Self-Reported Asthma Symptom Free Days||baseline to week 24|Self-reported asthma symptom free days were not entered into the study database.||||||
2720228|NCT01097694|Secondary|Change in Inflammatory Mediators in Exhaled Breath Condensate|Assessment of change in eicosanoids in the exhaled breath condensate|baseline to week 24|The exhaled breath condensate was not processed for inflammatory mediators.||||||
2720229|NCT01097694|Secondary|Change in Sputum Supernatant Differential, Supernatant Tryptase and IL-13|Change in sputum eosinophil and neutrophil percentage. Change in sputum supernatant tryptase as measured by ELISA. Change in sputum IL-13 level as measured by ELISA.|baseline to 24 weeks|"Sputum sample slide preparation quality was poor and samples meeting quality control were insufficient for analysis of sputum differential.~Insufficient study funds prevented assessment of sputum tryptase. IL-13 was below the detection limit of assay in sputum supernatant."||||||
2720230|NCT01097694|Secondary|Urinary Leukotriene E4|Change in urinary leukotriene E4 levels from baseline|6 months after start of treatment||||ng/mg Creatinine||Standard Deviation|Mean
2720231|NCT01097694|Secondary|Bronchoalveolar Lavage Cysteinyl Leukotrienes|Change in bronchoalveolar lavage cysteinyl leukotrienes levels from baseline|6 months after start of treatment||||pg/mL||Standard Deviation|Mean
2720232|NCT01097694|Secondary|Urinary Prostaglandin D2|Change in urinary Prostaglandin D2 levels from baseline|6 months after start of treatment||||ng/mg Creatinine||Standard Deviation|Mean
2720233|NCT01097694|Secondary|Bronchoalveolar Lavage Histamine|Change in bronchoalveolar lavage histamine levels from baseline|6 months after start of treatment||||nM||Standard Deviation|Mean
2720234|NCT01097694|Secondary|Airway Wall Area|Change in airway wall area as assessed by computerized tomography (CT)|6 months after start of treatment||||% of area||Standard Deviation|Mean
2720235|NCT01097694|Secondary|Airway Wall Thickness|Change in airway wall thickness as assessed by computerized tomography (CT)|6 months after start of treatment||||% of airway||Standard Deviation|Mean
2720236|NCT01097694|Secondary|Blood Eosinophils|Change in blood eosinophil count|6 months after start of treatment||||eosinophils per microliter||Standard Deviation|Mean
2720237|NCT01097694|Secondary|Endobronchial Biopsy Smooth Muscle Tryptase-positive Mast Cells|Change in the biopsy smooth muscle tryptase-positive mast cells from baseline at 6 months|6 months after start of treatment||||mast cells per mm2||Standard Deviation|Mean
2720238|NCT01097694|Secondary|Endobronchial Biopsy Total Tryptase-positive Mast Cells|Change in endobronchial biopsy total tryptase-positive mast cells from baseline at 6 months|6 months after start of treatment||||mast cells per mm2||Standard Deviation|Mean
2720239|NCT01097694|Secondary|Bronchoalveolar Lavage (BAL) PGD2|Change in bronchoalveolar lavage (BAL) PGD2 levels from baseline at 6 months|6 months after start of treatment||||pg/mL||Standard Deviation|Mean
2720240|NCT01097694|Secondary|BAL Eosinophil %|Change in BAL eosinophil percentage|6 months after start of treatment||||% eosinophils||Standard Deviation|Mean
2720241|NCT01097694|Secondary|BAL Neutrophil %|Change in BAL neutrophil percentage from baseline|6 months after start of treatment||||% neutrophils||Standard Deviation|Mean
2720242|NCT01097694|Secondary|Asthma Symptom Utility Index (ASUI)|Change in patient reported ASUI score The asthma symptom utility index (ASUI) is a 10-item weighted scale with a range from 0.2 to 1 with a higher value indicating improvement. The minimal important difference is 0.09.|6 months after start of treatment||||units on a scale||Standard Deviation|Mean
2720303|NCT01097421|Secondary|Patient Preference|Patients were asked about their preference regarding frequency of intake (once daily or three times daily)|8-12 weeks|FAS|||Participants|||Number
2720244|NCT01097694|Secondary|Asthma Control Questionnaire (ACQ)|Change in patient-reported ACQ score The six-item Asthma Control Questionnaire (ACQ-6) is a scale from 0 to 6 with a lower value denoting an improvement in asthma control. The minimal important difference is 0.5.|6 months after start of treatment||||units on a scale||Standard Deviation|Mean
2720245|NCT01097694|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|Change in Fractional Exhaled Nitric Oxide Measurement (ppb)|6 months after start of treatment||||parts per billion||Standard Deviation|Mean
2720246|NCT01097694|Secondary|Evening Peak Flow|Change in patient-reported evening peak flow measurement (L/s)|6 months after start of treatment||||L/second||Standard Deviation|Mean
2720247|NCT01097694|Secondary|Morning Peak Flow Measurement|Change in patient-reported morning peak flow measurement (L/s)|6 months after start of treatment||||L/second||Standard Deviation|Mean
2720248|NCT01097694|Secondary|FEV1%|Change in FEV1% of predicted|6 months after start of treatment||||% of predicted||Standard Deviation|Mean
2720249|NCT01097694|Secondary|FEV1 in Liters|Change in FEV1 in treatment group compared to placebo group|6 months after start of treatment||||L||95% Confidence Interval|Mean
2720250|NCT01097694|Secondary|Number of Asthma Exacerbations|Number of asthma exacerbations experienced from randomization to study completion.|Up to 24 weeks||||events|||Number
2720251|NCT01097694|Secondary|Change in Maximum Post-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) %||6 months after start of treatment||||% of predicted||Standard Deviation|Mean
2720252|NCT01097694|Secondary|Bronchoalveolar Lavage (BAL) Fluid Tryptase Level|Change in BAL fluid tryptase levels after 24 weeks of imatinib vs. placebo|6 months after start of treatment||||ng/mL||Standard Deviation|Mean
2720253|NCT01097694|Secondary|Serum Total Tryptase|Change in serum total tryptase after 24 weeks of imatinib vs placebo treatment|6 months after start of treatment||||ng/ml||Standard Deviation|Mean
2720254|NCT01097694|Primary|Change in Mean Methacholine Responsiveness as Assessed by the Provocation Concentration Causing a 20% Fall in Forced Expiratory Volume in One Second (FEV1) (PC20) at Month 3 and 6 Versus Baseline|"Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups.~PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1)."|Over 6 months from beginning of treatment||||Log2 Ratio||Standard Deviation|Mean
2720255|NCT01097668|Secondary|The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).|Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.|16 and 20 weeks|ITT population at week 16 and 20 n=21 (Intradermal injection) ITT population at week 16 and 20 n=22 (Subcutaneous injection) MRI population at week 16 and 20 n=17 (Intradermal injection) MRI population at week 16 and 20 n=20 (Subcutaneous injection)|||MRI lesions||95% Confidence Interval|Mean
2720256|NCT01097668|Primary|Safety and Tolerability|Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.|48 weeks|The Safety population will be denoted as the ‘ITT population’ for the summarisation of safety endpoints.|||participants|||Number
2720257|NCT01097655|Other Pre-specified|Prevalence of Adverse Events (Weeks 0-144), Per Participant|Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of participants|||Number
2720258|NCT01097655|Other Pre-specified|Prevalence of Adverse Events (Weeks 0-144), Per Event|Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of adverse events|Adverse Events||Number
2720259|NCT01097655|Primary|Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||log copies/mL||Standard Deviation|Mean
2720260|NCT01097655|Primary|Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count|Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||cells/μL||Standard Deviation|Mean
2720261|NCT01097629|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
2720304|NCT01097421|Primary|Level of Adherence|Points on Morisky scale|8-12 weeks|FAS|||Participants|||Number
2720262|NCT01097629|Primary|Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
2720263|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720264|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720265|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720266|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720267|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720268|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720305|NCT01097421|Primary|Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment|Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.|8-12 weeks|Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment.|||Percent||95% Confidence Interval|Number
2720269|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720270|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720271|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720272|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720273|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720274|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720275|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720330|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||5 days postoperatively||||mg/L||Standard Error|Mean
2720276|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720277|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
2720278|NCT01097616|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
2720279|NCT01097616|Primary|Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
2720280|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720281|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720282|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
2720283|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720284|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720285|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
2720286|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720287|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
2720288|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
2720289|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720290|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720331|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||Postoperative 6th hours||||mg/L||Standard Error|Mean
2720291|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720292|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720293|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720294|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720295|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720296|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
2720297|NCT01097460|Secondary|To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination||2 years|||||||
2720298|NCT01097460|Primary|Incidence of Treatment-emergent AE's||2 years|Patients that received at least one dose|||participants|||Number
2720299|NCT01097421|Secondary|Patients Global Impressions (PGI)|Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.|8-12 weeks|FAS|||Participants|||Number
2720300|NCT01097421|Secondary|Clinical Global Impressions (CGI)|Clinical Global Impression (CGI) scale at final visit|8-12 weeks|FAS|||Participants|||Number
2720301|NCT01097421|Secondary|Pramipexole (PPX) Dose|mean Pramipexole (PPX) dose|pre-treatment and after 8-12 weeks|FAS|||mg/24 hr||Standard Deviation|Mean
2720306|NCT01097343|Primary|Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230|P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.|Approximately 90 days|All patients completed the clinical protocol.|||Number of Patients with PRU>230|||Number
2720307|NCT01097330|Secondary|Quality of Life Score|Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine.|At 6 months follow-up|Participants with data collected at 6 months|||score on a scale||Full Range|Mean
2720308|NCT01097330|Secondary|Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial.|Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial.|from randomization until final follow-up||||participants|||Number
2720309|NCT01097330|Primary|Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death|"Number of participants with a composite outcome of any of:~Appropriate Implantable Cardioverter Defibrillator (ICD) therapy [Including antitachycardia pacing (ATP) and shocks]~Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation~Sudden Cardiac Death"|From 30 days following randomization until final follow-up visit||||participants|||Number
2720310|NCT01097304|Secondary|Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections|Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.|Baseline and 6 months|tissue slides with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis|||% change||Standard Deviation|Mean
2720311|NCT01097304|Secondary|Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Deoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention||Baseline and 6 months|analysis was limited to participants with baseline and 6-month gastric fluid|||% of total bile acid||Inter-Quartile Range|Median
2720312|NCT01097304|Secondary|Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Ursodeoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention||Baseline and 6 months|analysis was limited to participants with baseline and 6-month gastric fluid|||% of total bile acid||Inter-Quartile Range|Median
2720313|NCT01097304|Primary|Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining|8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.|Baseline to 6 months|participants with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis|||% of strongly/moderately stained nuclei||Standard Deviation|Mean
2720314|NCT01097057|Primary|Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days|Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days|Up to Four Apheresis Days|Note: No patients were in this category.|||Participants|||Count of Participants
2720315|NCT01097057|Primary|Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg|Number of participants requiring one or two apheresis collection days to reach collection goal.|Up to Four Apheresis Days||||Participants|||Count of Participants
2720316|NCT01097057|Primary|Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days|Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.|Up to Four Apheresis Days||||Participants|||Count of Participants
2720317|NCT01097057|Primary|Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)|Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.|One Month||||Participants|||Count of Participants
2720318|NCT01097044|Secondary|Total Severity of Phototoxic Reactions Experienced by Participants Over the Entire Study|"The days on which the participant experienced pain as a result of phototoxic reactions (caused by exposure to natural light) was recorded in a study diary.~On each day such a reaction occurred, the participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert Pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The total severity of phototoxic reactions was determined by the sum of daily 11-point Likert scale scores that occurred during phototoxic reactions. The overall sum of the severity per participant over the entire study was analyzed. The theoretical minimum score is 0 and the maximum possible score is 1800."|Daily for 6 months.|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||units on a scale||Standard Deviation|Mean
2720319|NCT01097044|Secondary|Number of Phototoxic Reactions Experienced by Participants|"The days on which the participant experienced pain as a result of phototoxic reactions (caused by exposure to natural light) was recorded in a study diary. On each day such a reaction occurred, the participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The number of phototoxic reactions was determined by counting the number of episodes on which participants report a 11-point Likert scale score of 4 or more for one or more consecutive days."|Daily for 6 months|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||Episodes||Full Range|Median
2720320|NCT01097044|Secondary|Number of Participants With Phototoxic Reactions With Likert Severity Scores ≥ 4 and ≥ 7|"The number of participants who experienced phototoxic reactions with Likert severity scores ≥ 4 and severity scores ≥7 were recorded.~A derived endpoint was used. The number of participants who reported at least one phototoxic reaction with a Likert severity score of ≥ 4 was recorded. For severity scores ≥ 7, the number of patients who reported at least one phototoxic reaction with a Likert severity score of ≥ 7 was recorded.~The 11-point Likert pain scale ranges from minimum of 0 to maximum of 10. The 11-point Likert pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain."|Daily for 6 months|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||Count of Participants|||Number
2720321|NCT01097044|Secondary|Change of Total Protoporphyrin IX Level in Participants|"This was an exploratory assessment only to analyze whether afamelanotide-induced change in sun exposure would result in a reduction of protoporphyrin IX.~The changes of the Total Protoporphyrin IX Level (μg/dL) from Screening Visit (ITT Population) were measured between the two groups.~The Protoporphyrin IX level is a laboratory parameter that is measured in specialist labs."|Baseline, Day 60, Day 120, Day 180|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||mcg/dL||Standard Deviation|Mean
2720322|NCT01097044|Secondary|Quality of Life Measured by Participant Completed Questionnaire|"Erythropoietic Protoporphyria Quality of Life Measure (EPP-QoL) is used to measure the quality of life of participants.~The total EPP-QoL score ranges from 0 to 100, with a score of 0 as the worst quality of life and score of 100 as the best quality of life."|Day 0, Day 60, Day 120, Day 180|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||units on a scale||Full Range|Median
2720323|NCT01097044|Secondary|Maximum Severity of Phototoxic Reaction Experienced by Participants|"The days on which the participant experienced pain as a result of phototoxic reactions (caused by exposure to natural light) was recorded in a study diary. On each day such a reaction occurred, the participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The maximum severity of a phototoxic reaction was determined by the highest daily 11-point Likert scale score that occurred during that phototoxic reaction."|Daily for 6 months|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||score on a scale||Full Range|Median
2720324|NCT01097044|Primary|Time in Direct Sunlight Between 10:00-15:00 on Pain-free Days|"The amount of direct sunlight exposure between 10:00 and 15:00 hours on days when no pain was experienced (e.g. 11-point Likert pain score of 0). Time was recorded in a patient dairy using 15 minute time blocks.~The pain score is measured by the 11-point Likert Pain scale with minimum of 0 and maximum of 10.~Likert Pain scale of 0 represents no pain and 10 represents worst imaginable pain."|Daily for 6 months|"One active participant and one placebo participant withdrew after Baseline assessment and no data was provided for the analysis of this endpoint.~The overall number of participants analyzed differs from the total number of study participants because the data was either incomplete and/or missing."|||Hours||Full Range|Median
2720325|NCT01097005|Secondary|Bacteriological Relapse Related to Duration of Clarithromycin Administration|Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion|36 months|End of study (completers). Analysis of bacteriological relapse.|||participants|||Number
2720326|NCT01097005|Secondary|"Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator"|"Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales (Effective, Ineffective, Deterioration, Impossible)"|When treatment with clarithromycin is discontinued, from 40 days to 1232 days|Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.|||Number of patients|||Number
2720327|NCT01097005|Primary|Bacilli Negative Conversion Rate|Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin|During the treatment with clarithromycin, from 40 days to 1232 days|Analysis of the bacilli negative conversion|||participants|||Number
2720328|NCT01096992|Secondary|Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)|Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts;|Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.|Two participants in the phase II portion of the study were not evaluable for response due to loss to follow-up.|||Participants|||Count of Participants
2720329|NCT01096992|Primary|Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)|MTD defined as highest dose level in which 6 participants have been treated with </= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade >/= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT.|After 4 week cycle|Maximum Tolerated Dose (MTD) was not established as an objective for the phase II portion of this study and was not collected.|||mg/m^2|||Number
2720334|NCT01096849|Secondary|Percentage of Patients With a Superinfection or New Infection in the ME Population|Superinfections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after the first infusion through EOT. New infections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after EOT.|Day 1 to to End of Study (Day 40)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients|||Number
2720335|NCT01096849|Secondary|Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population|Patients who had a clinical relapse (defined as the return of clinical signs and symptoms requiring antibiotic therapy) or microbiological recurrence (defined as eradication of the original pathogen[s] at the TOC visit but regrowth at the level >10^5 CFU/mL by the LTFU [long term follow up] visit).|Day 1 to LTFU (Day 40)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients|||Number
2720336|NCT01096849|Secondary|Time (Days) to Defervescense in the MITT Population|Defervescence is defined as the absence of fever <37.7 degrees Celsius and is assessed in patients who were afebrile at baseline.|Day 1 to End of Study (Day 40)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||days||Standard Error|Mean
2720337|NCT01096849|Secondary|Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population|"Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit.~The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to End of Study (Day 40)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||days||Standard Error|Mean
2720338|NCT01096849|Secondary|Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population|Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline.|Day 1 to End of Study (Day 40)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||days||Standard Error|Mean
2720339|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
2720340|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
2720341|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients|||Number
2720342|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to EOT (Day 5)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||percentage of patients||95% Confidence Interval|Number
2720343|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to EOT (Day 5)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
2720344|NCT01096849|Secondary|Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population|"Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the EOT visit.~The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to EOT (Day 5)|The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC.|||percentage of patients||95% Confidence Interval|Number
2721547|NCT01086228|Secondary|Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2720345|NCT01096849|Secondary|Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population|"Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit.~The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to TOC (Day 12)|The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC.|||percentage of patients||95% Confidence Interval|Number
2720346|NCT01096849|Secondary|Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population|"Investigator's assessment criteria defined Clinical Cure as resolution of baseline clinical signs and symptoms of infection through the TOC visit.~The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to TOC (Day 12)|The intent-to-treat (ITT) population was defined as all randomized patients.|||percentage of patients||95% Confidence Interval|Number
2720347|NCT01096849|Primary|Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.|Day 1 to the end of study (Day 40)|The Safety population was defined as all randomized patients who received any amount of study drug.|||percentage of patients|||Number
2720348|NCT01096849|Primary|Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as clinically evaluable (CE) patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
2720349|NCT01096849|Primary|Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||percentage of patients||95% Confidence Interval|Number
2720350|NCT01096823|Primary|Disease Activity Scale (DAS)28|"is a combined index that measures disease activity in patients with RA and remains a more thorough, established alternative to standard medical exams. This index includes a 28 tender joint count, 28 swollen joint count, Erythrocyte Sedimentation Rate (ESR), and general health assessment using a visual analogue scale. The ESR indirectly measures inflammation in the body and involves collecting blood samples, which will be performed by a qualified phlebotomist.~The DAS score is a complicated formula based on many factors so there are no set ranges, but the published standards are as follows:~A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. Source: DAS-Score.nl. Available at http://www.das-score.nl/www.das-score.nl/index.html. Accessed February 5, 2009."|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
2720351|NCT01096823|Primary|Health Assessment Questionnaire (HAQ)|"Items include questions about dressing and grooming, rising, eating, walking, hygiene, reaching, grip and making activities. The HAQ is one of the most widely recognized measures of patient functioning, with acceptable reliability and validity. It has been used successfully with adolescents as young as 13 years of age~Range: 0-100, lower scores indicate better health"|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
2720352|NCT01096823|Primary|Pain Disability Index (PDI)|"The PDI assess the impact of pain on ability to participate in basic life activities, including social activity, sexual behavior, self-care and life-support activity. The PDI has been used with patients as young as 15. Good internal reliability (α = .82) and validity have been reported. It takes less than 5 minutes to complete.~7 items, total measure range: 0-70, higher scores = higher interference/disability"|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
2720353|NCT01096823|Primary|Health Related Quality of Life - Short Form-36 (SF-36)|"The Health Related Quality of Life - Short Form-36 (SF-36) is a generic core HRQOL measure yielding an 8-scale profile of functional health and well being. The SF-36 performs comparatively better than other HRQOL measures in terms of reliability, validity, lightness of respondent/administrative burden. It can be completed in 5-10 minutes and has been used with children as young as 10 years of age.~Subscales - all ranges 0-100 with higher scores indicating increased quality of life Bodily Pain, 2 items General Health, 5 items Vitality, 4 items Mental Health, 5 items"|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
2720354|NCT01096810|Secondary|Antitumor Effect|To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis|Antitumor effect|immunophenotyping was not performed in this study||||||
2720392|NCT01096667|Secondary|Baseline 24-hour Average Urinary Glucose Excretion|Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours).|24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average urinary glucose excretion|||grams/day||Standard Deviation|Mean
2720355|NCT01096810|Primary|Response Rate|"The response rate - percentage of participants with overall response.~Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least >50% reduction in SPEP, at least >90% reduction or <200 mg in UPEP, at least >50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate."|from date of start of treatment until the date of best documented response up to date of progression||||percentage of participants|||Number
2720356|NCT01096810|Primary|Time to Progression|"To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles).~Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: >25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), >25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), >25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause)."|From date of treatment until the date of first documented progression||||cycles||Full Range|Median
2720357|NCT01096784|Secondary|Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3||Day 7 and Week 40 Post Menstrual Age|FAS.|||microgram per liter||Standard Deviation|Mean
2720358|NCT01096784|Secondary|Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3||Day 0 and Week 40 Post Menstrual Age|FAS.|||microgram per liter||Standard Deviation|Mean
2720359|NCT01096784|Secondary|Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3|Serum samples were collected from treated and control participants for quantification of IGF-1 using validated immunoassays. Target range of serum IGF-1 was 28-109 mcg/L. The percentage of serum IGF-1 levels across treated participants that fall within the range was reported.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS was analysed.|||percentage of serum concentration|||Number
2720360|NCT01096784|Secondary|Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|Safety Analysis Set (SAF) included all randomized participants who received the study drug and participants in the control group who received standard of care, and for whom at least 1 safety assessment was completed.|||participants|||Number
2720361|NCT01096784|Secondary|Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study|ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS.|||Percentage of participants|||Number
2720362|NCT01096784|Secondary|Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP)|Integration of the maximum severity of ROP stage and the duration of the time interval with respect to each retinal examination. AUC for the maximum severity of ROP was calculated using the trapezoidal rule. The area between each 2 visits was calculated by multiplying the average of the maximum severities of the 2 visits by the difference in days and analyzed using the van Elteren test. ROP is classified according to the International Classification and is subdivided into 5 stages (1-5) with higher values representing greater severity.|Every 1-2 weeks starting at 31 weeks PMA/ EOS +/- 4 days|Full analysis set with number of participants evaluable for this outcome.|||ROP severity score*days||Standard Deviation|Mean
2720363|NCT01096784|Secondary|Percentage of Participants With Intraventricular Hemorrhage (IVH)|Development of intraventricular hemorrhage was assessed by cerebral ultrasound and coded as a binary endpoint (presence or absence of IVH).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||percentage of participants|||Number
2720364|NCT01096784|Secondary|Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS|Brain volume was measured using cerebral magnetic resonance imaging (MRI). Brain volume included cerebrospinal volume, gray matter volume, white matter volume, and total cerebellar volume|40 Weeks PMA/ (EOS) +/- 4 days|FAS|||cubic centimeter||Standard Deviation|Mean
2720365|NCT01096784|Secondary|Rate of Change in Head Circumference|The rate of change is the head circumference change per day in centimetre (cm).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||cm/day||95% Confidence Interval|Mean
2720366|NCT01096784|Secondary|Rate of Change in Length|The rate of change is the length change per day in centimeter (cm).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||centimeter per day (cm/day)||95% Confidence Interval|Mean
2720367|NCT01096784|Secondary|Rate of Change in Body Weight|The rate of change is the rate of specific body weight change per day in kilogram (kg).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||kilogram per day (kg/day)||95% Confidence Interval|Mean
2720368|NCT01096784|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)|"Severity of BPD as mild, moderate and severe were based on the National Institute of Child Health and Human Development (NICHD) guidelines for preterm infants born at gestational age (GA) less than (<) 32 weeks.~Mild: oxygen requirement during the first 28 days but in room air at PMA 36 weeks or discharge to home, whichever comes first.~Moderate BPD: oxygen requirement during the first 28 days and oxygen <30 percent (%) at PMA 36 weeks or discharge to home, whichever comes first.~Severe BPD: oxygen requirement during the first 28 days and oxygen greater than equal (≥)30% through head hood or nasal canula, or continuous positive airway pressure, or mechanical ventilation, or high flow nasal cannula ≥2 L/min at PMA 36 weeks or discharge to home, whichever comes first."|At 36 Weeks Post Menstrual Age|FAS with participants evaluable for this outcome.|||participants|||Number
2720370|NCT01096784|Primary|Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population|ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).|End of study|Full Analysis Set (FAS) included all randomized participants who received the study drug and participants in the control group who received Standard of Care.|||participants|||Number
2720371|NCT01096771|Secondary|Hypertriglyceridemia|Defined as triglyceride level >400|96 hours||||participants|||Number
2720372|NCT01096771|Secondary|Allergic Reactions||96 hours||||participants|||Number
2720373|NCT01096771|Secondary|Hospital Length of Stay||30 days||||days||Standard Deviation|Mean
2720374|NCT01096771|Secondary|Biomarkers (C-reactive Protein)||96 hours||||mg/L||Standard Deviation|Mean
2720375|NCT01096771|Secondary|Organ Failures||30 days||||participants|||Number
2720376|NCT01096771|Secondary|New Infection|We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.|30 days||||participants|||Number
2720377|NCT01096771|Secondary|30 Day Mortality||30 days||||participants|||Number
2720378|NCT01096771|Secondary|PaO2:FiO2 Ratio|PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.|4 days||||mmHg||Standard Deviation|Mean
2720379|NCT01096771|Secondary|Ventilator Days||30 days||||days||Standard Deviation|Mean
2720380|NCT01096771|Primary|Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations||96 hours|Each arm has one less subject than specified in the participate flow module. One is secondary to the fact that the subject refused the 2nd bronchoscopy and the other is because the primary physician felt the subject was too sick to undergo the 2nd bronchscopy.|||pg/mL||Standard Deviation|Mean
2720381|NCT01096680|Secondary|PVT Scores by Timepoint|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS|||msec||Standard Error|Least Squares Mean
2720382|NCT01096680|Secondary|Psychomotor Vigilance Task (PVT) Scores|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS|||msec||Standard Error|Least Squares Mean
2720383|NCT01096680|Secondary|KSS Scores by Timepoint|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS|||Units on a scale||Standard Error|Least Squares Mean
2720384|NCT01096680|Secondary|Karolinska Sleepiness Scale (KSS) Scores|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS|||Units on a scale||Standard Error|Least Squares Mean
2720385|NCT01096680|Primary|Maintenance of Wakefulness Test (MWT)|"The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to stay awake as long as possible during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better."|Over a period of 8 hours|Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.|||Minutes||Standard Error|Least Squares Mean
2720386|NCT01096667|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE.|Up to 28 days (treatment period)|Analysis population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2720387|NCT01096667|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug.|Up to 63 days (including run-in, treatment period, and follow-up)|Analysis population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2720388|NCT01096667|Secondary|Change From Baseline in FPG at Week 2|For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).|Baseline and Week 2|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 2 for FPG (observed cases).|||mg/dL||80% Confidence Interval|Least Squares Mean
2720389|NCT01096667|Secondary|Change From Baseline in FPG at Week 4|For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 4 for FPG (observed cases).|||mg/dL||80% Confidence Interval|Least Squares Mean
2720390|NCT01096667|Secondary|Baseline Fasting Plasma Glucose (FPG)|For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).|Baseline|All randomized participants.|||mg/dL||Standard Deviation|Mean
2720391|NCT01096667|Secondary|Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4|Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours). In the case of missing data, LOCF.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for 24-hour urinary glucose excretion.|||grams/day||80% Confidence Interval|Least Squares Mean
2720393|NCT01096667|Secondary|Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4|Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough heart rate.|||beats per minute||80% Confidence Interval|Least Squares Mean
2720394|NCT01096667|Secondary|Baseline Seated, Triplicate Trough Heart Rate|Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures.|Baseline|All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough heart rate.|||beats per minute||Standard Deviation|Mean
2720395|NCT01096667|Secondary|Change From Baseline on Nighttime Average Heart Rate at Week 4|Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||Beats per minute||80% Confidence Interval|Least Squares Mean
2720396|NCT01096667|Secondary|Change From Baseline on Daytime Average Heart Rate at Week 4|Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||Beats per minute||80% Confidence Interval|Least Squares Mean
2720397|NCT01096667|Secondary|Change From Baseline on 24-hour Average Heart Rate at Week 4|Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||Beats per minute||80% Confidence Interval|Least Squares Mean
2720398|NCT01096667|Secondary|Baseline 24-hour, Daytime and Nightime Average Heart Rate|Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|up to 24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime heart rate.|||beats per minute||Standard Deviation|Mean
2720399|NCT01096667|Secondary|Change From Baseline in Seated, Triplicate Trough DBP at Week 4|Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough DBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720400|NCT01096667|Secondary|Baseline Seated, Triplicate Trough DBP|Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures.|Baseline|All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough DBP.|||mmHg||Standard Deviation|Mean
2720401|NCT01096667|Secondary|Change From Baseline on Nighttime Average DBP at Week 4|Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720402|NCT01096667|Secondary|Change From Baseline on Daytime Average DBP at Week 4|Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720403|NCT01096667|Secondary|Change From Baseline on 24-hour Average DBP at Week 4|Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720404|NCT01096667|Secondary|Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)|Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|up to 24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime DBP.|||mmHg||Standard Deviation|Mean
2720405|NCT01096667|Secondary|Change From Baseline in Seated, Triplicate Trough SBP at Week 4|Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720406|NCT01096667|Secondary|Baseline Seated, Triplicate Trough SBP|Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures.|Baseline|All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough SBP.|||mmHg||Standard Deviation|Mean
2720407|NCT01096667|Secondary|Change From Baseline on Nighttime Average SBP at Week 4|Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720408|NCT01096667|Secondary|Change From Baseline on Daytime Average SBP at Week 4|Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720409|NCT01096667|Secondary|Baseline Average Daytime and Nighttime SBP|Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Daytime: 16 hours; Nighttime: 8 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for daytime and nighttime SBP.|||mmHg||Standard Deviation|Mean
2720410|NCT01096667|Primary|Change From Baseline on 24-hour Average SBP at Week 4|Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
2720411|NCT01096667|Primary|Baseline 24-hour Average Systolic Blood Pressure (SBP)|Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).|24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour SBP.|||mmHg||Standard Deviation|Mean
2720412|NCT01096589|Secondary|Assessment of Safety by Incidence of Adverse Events.||3 weeks||||No. of treatment-emergent adverse events|||Number
2720413|NCT01096589|Primary|Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.||baseline and after 3 weeks of treatment|Patients must have completed the first week.|||% volume change measured in mL.||Standard Deviation|Mean
2720414|NCT01096550|Primary|Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)||6 months post-baseline||||percentage of opioid dependent subjects|||Number
2720415|NCT01096446|Secondary|Initiation of Glucose|Infants were monitored to see if insulin was started to control hyperglycemia.|First 7 days of life|||||||
2720416|NCT01096446|Secondary|Maintain Appropriate for Gestational Age Status at Discharge|Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.|Entire hospital stay|||||||
2720417|NCT01096446|Secondary|Infants Will Achieve 90 Calories/Kilogram/Day|Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.|First 14 days of Life|||||||
2720418|NCT01096446|Secondary|Regain Birthweight|Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.|First 2 weeks of life|||||||
2720419|NCT01096446|Primary|Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl|Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.|First 7 days of life|This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater|||participants|||Number
2720420|NCT01096342|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient's objective status is first noted to be either an sCR, CR, PR, or VGPR to the earliest date progression is documented, assessed up to 3 years|Duration of Response was not analyzed due to lack of responses.||||||
2720421|NCT01096342|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years|All 15 evaluable participants were analyzed for Progression-Free Survival.|||months||95% Confidence Interval|Median
2720422|NCT01096342|Primary|Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.|"Complete Response (CR):~Negative immunofixation of serum and urine Normalization of FLC ratio < 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas~Stringent Complete Response (sCR):~CR, as above, with absence of clonal cells in bone marrow~Partial Response (PR):~One of the following:~A ≥ 50% reduction of measurable serum M-protein.~A reduction in 24h measurable urinary M-protein by ≥ 90% or to <200 mg per 24h.~A ≥ 50% decrease in the difference between involved and uninvolved FLC levels.~≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30%~A ≥50% reduction in the size of soft tissue plasmacytomas.~Very Good Partial Response (VGPR):~PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis."|Up to 3 years|Fifteen of the 16 accrued Phase II participants were analyzed (1 participant was a protocol violation).|||participants|||Number
2720423|NCT01096316|Secondary|Potential Facilitators and Barriers to Sustainability|Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.|18 months|||||||
2720462|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720424|NCT01096316|Secondary|Quality of Depression Care Indicators|Intervention impact on quality of depression care indicators and satisfaction with depression care. Number of participants receiving 4 or more mental health visits are reported. Receiving 4 or more mental health visits has previously been used in depression randomized control trials as a measure of the quality of depression treatment received by a patient|12 months||||participants|||Number
2720425|NCT01096316|Primary|Functional Outcome|Impact of the intervention on functional outcomes of patients. Functional impairment was measured using the Sheehan Disability Scale. The Sheehan disability scale is the average of 3 items assessing impairment in social, work and family responsibilities. Each item is rated 0 (no impairment) to 10 (totally impaired) and the 3 ratings are averaged for the Sheehan disability scale reported below.|12 months||||units on a scale||Standard Deviation|Mean
2720426|NCT01096316|Primary|Depression Treatment Outcome|Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response. In particular, the depression scale from the Hopkins Symptom Checklist 20 (SCL-20) was used to assess depression severity at the assessments. The SCL-20 ranges from 0 (no depression) to 4 (severe depression),|12 months||||units on a scale||Standard Deviation|Mean
2720427|NCT01096186|Secondary|Patient Global Impression (PGI)|"Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.~Patient Global Impression 0-7 - higher value indicates increased improvement from study start"|9 months|All enrolled subjects with available data|||units on a scale||Standard Deviation|Mean
2720428|NCT01096186|Secondary|Total UPDRS Parts I-IV|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient.~Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data|||units on a scale||Standard Deviation|Mean
2720429|NCT01096186|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study.~Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data|||units on a scale||Standard Deviation|Mean
2720430|NCT01096160|Secondary|Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo|The percent inhibition of collagen-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of collagen (2 µg/mL) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10, only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo.|Baseline and Day 10 (5 hours postdose)|All participants who received at least one dose of the investigational drug and had assessment of collagen-induced platelet aggregation on Day 10|||Percent inhibition||Standard Deviation|Mean
2720431|NCT01096160|Secondary|Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo|The percent inhibition of ADP-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of ADP (2.5 µM) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10 only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo.|Baseline and Day 10 (5 hours postdose)|All participants who received at least one dose of the investigational drug and had assessment of ADP-induced platelet aggregation on Day 10|||Percent inhibition||Standard Deviation|Mean
2720432|NCT01096160|Secondary|Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo|Assessment of whole blood samples for cGMP analysis, based on samples obtained predose as well as 4 and 24 hours postdose on Day 1 and Day 10, and predose only on Day 4. The change from baseline in cGMP was assessed at 24 hours postdose on Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.|Baseline and Day 10|All participants who received at least one dose of the investigational drug and had cGMP assessments at Baseline and on Day 10|||nanomoles (nM)||Standard Deviation|Least Squares Mean
2720433|NCT01096160|Secondary|Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo|Assessment of the central, ascending aortic blood pressure augmentation index (AIx), based on measurement of central pulse pressure at selected time points on Day 10, as measured by applanation tonometry of the radial artery. This outcome measure assessed the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.|Day 10|All participants who received at least one dose of the investigational drug and had AIx assessment on Day 10|||mmHg||Standard Deviation|Least Squares Mean
2720434|NCT01096160|Primary|Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo|Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.|Day 10 (24 hours postdose)|All participants who received at least one dose of the investigational drug and had HR assessments 24 hours postdose on Day 10.|||Beats per minute||Standard Deviation|Mean
2720435|NCT01096160|Primary|Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo|Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.|Baseline and Day 10|All participants who received at least one dose of the investigational drug and had SBP assessments at Baseline and on Day 10|||Millimeters of mercury (mmHg)||Standard Deviation|Least Squares Mean
2720436|NCT01096160|Primary|Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE|Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10.|Up to 10 days|All participants who received at least one dose of the investigational drug|||Count of Participants|||Number
2720437|NCT01096160|Primary|Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up|Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.|Up to 24 days|All participants who received at least one dose of the investigational drug|||Count of Participants|||Number
2720438|NCT01096056|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720439|NCT01096056|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720440|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720441|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720442|NCT01096056|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2720443|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720444|NCT01096056|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2720445|NCT01096056|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720446|NCT01096056|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR)|GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||fold change||95% Confidence Interval|Geometric Mean
2720447|NCT01096056|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2720448|NCT01096056|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2720449|NCT01096056|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2720450|NCT01096056|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2720451|NCT01096056|Primary|Number of Subjects Reporting Fever Grade 2 or Higher|Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature >38 degree centigrade (°C).|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2720452|NCT01096017|Secondary|Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation|Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation|At two visits during a maximum of 15 days||||Minutes||Standard Deviation|Mean
2720453|NCT01096017|Secondary|Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation|Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.|At two visits during a maximum of 15 days||||Participants|||Number
2720454|NCT01096017|Secondary|Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|Time to peak measurement of FEV1 (min)|At two visits during a maximum of 15 days||||Minutes||Full Range|Median
2720455|NCT01096017|Secondary|Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percent change||Full Range|Geometric Mean
2720456|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720457|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720458|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720459|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720460|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720461|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
2720463|NCT01096017|Primary|FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation|FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation|At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.||||milliLiters x minutes||Full Range|Geometric Mean
2720464|NCT01095978|Secondary|Termination of Treatment|The number of participants who discontinued treatment is summarized.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720465|NCT01095978|Secondary|Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)|Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.|Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720466|NCT01095978|Secondary|Adverse Effects|The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720467|NCT01095978|Primary|Therapeutic Response|Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720468|NCT01095978|Primary|Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)|Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.|||Participants|||Number
2720469|NCT01095978|Primary|Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia|Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.|||Participants|||Number
2720470|NCT01095978|Primary|Auscultation Findings|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720471|NCT01095978|Primary|Dyspnoea|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720472|NCT01095978|Primary|Cough and Its Character|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
2720473|NCT01095978|Primary|Body Temperature|Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.|||Participants|||Number
2720474|NCT01095887|Primary|Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant||3 months after kidney transplant surgery||||participants|||Number
2720475|NCT01095835|Other Pre-specified|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion|This outcome measure presents percentage of participants with a combined response of HBsAg < 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720476|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Below Limit of Quantification|HBV-DNA limit < 6 IU/mL was defined as below quantification.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2721548|NCT01086228|Secondary|Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2720477|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720478|NCT01095835|Other Pre-specified|Percentage of Participants With ALT Normalization||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720479|NCT01095835|Secondary|Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy|Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.|At the end of the treatment period at Week 96|The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.|||percentage of participants|||Number
2720480|NCT01095835|Secondary|Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment||At the end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.|||IU/mL||Standard Deviation|Mean
2720481|NCT01095835|Secondary|Percentage of Participants Achieving Histological Response|Histological response was defined as an improvement by >/= 2 in the Necroinflammatory Grading and/or by an improvement by >/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720482|NCT01095835|Secondary|Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL|Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off <2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720483|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.|At the end of 24 weeks of follow-up at Week 120|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720484|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at the End of Treatment|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.|At end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720485|NCT01095835|Primary|Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period|Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to <20,000 copies/mL (<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2720486|NCT01095796|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).|||percentage of participants|||Number
2720487|NCT01095796|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT Analysis Set. The missing = excluded (M = E) method was used in which all participants with missing data were excluded from analysis.|||cells/µL||Standard Deviation|Mean
2720488|NCT01095796|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT Analysis Set|||percentage of participants|||Number
2720489|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 Modified Intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.|||percentage of participants|||Number
2720490|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2720491|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2720492|NCT01095796|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2720493|NCT01095757|Primary|Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg||Within the first 4 days following the first dose of Plerixafor||||participants|||Number
2720494|NCT01095757|Secondary|Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)||Within the first 4 days following the first dose of Plerixafor||||days||Standard Deviation|Mean
2720495|NCT01095757|Primary|Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis||Within the first 4 days following the first dose of Plerixafor||||participants|||Number
2720496|NCT01095666|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1C values at Week 24 (LOCF)|||Percentage of Participants|||Number
2720497|NCT01095666|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
2720498|NCT01095666|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PMG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2720499|NCT01095666|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2720500|NCT01095666|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
2720501|NCT01095653|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||Percentage of participants||Standard Error|Mean
2721549|NCT01086228|Secondary|Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2720502|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
2720503|NCT01095653|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PLMG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2720504|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2720505|NCT01095653|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
2720506|NCT01095510|Secondary|Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations|Data was not reported due to change in planned analysis.|Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8|No participant agreed to obtain pharmacokinetic (PK) blood sampling for antigenic and functional C1 INH levels. Hence, it was planned not to be analyzed.||||||
2720507|NCT01095510|Secondary|Time to Complete Resolution of the Attack||Within 1 week following treatment|ITT-E population.|||hours||Full Range|Median
2720508|NCT01095510|Secondary|Time to Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|ITT-E population|||hours||Full Range|Median
2720509|NCT01095510|Primary|Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|Intent-to-treat efficacy (ITT-E) population included all participants with baseline and at least one post-infusion investigator assessment of the hereditary angioedema (HAE) attack.|||participants|||Number
2720510|NCT01095497|Secondary|Number of Subjects With C1INH Antibodies||18 days in each treatment period|||||||
2720511|NCT01095497|Secondary|C1 Inhibitor (C1INH) and C4 Levels||18 days in each treatment period|||||||
2720512|NCT01095497|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.||18 days in each treatment period||||Participants|||Number
2720513|NCT01095250|Secondary|Change in Immunosuppressive Medication Score From Baseline to Week 28|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
2720514|NCT01095250|Secondary|Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
2720515|NCT01095250|Secondary|Change From Baseline in Quality of Life/Patient Reported Outcome Assessments|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
2721691|NCT01085045|Secondary|Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1|Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%|Day 1|MITT Population - not including the 4 sentinel patients.|||Percentage of Participants|||Number
2720516|NCT01095250|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
2720517|NCT01095250|Secondary|Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
2720518|NCT01095250|Primary|Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|The results of Study CAIN457C2303 did not meet the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.||||||
2720519|NCT01095094|Secondary|Grade 3-5 Toxicity as Assessed by NCI CTC v3.0|Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module.|at 6 months from start of treatment||||participants|||Number
2720520|NCT01095094|Primary|Progression-free Survival|Number of patients that remained disease free at 6 months from start of treatment.|At 6 months||||participants|||Number
2720521|NCT01095003|Secondary|Duration of Response|Measured from the first time that measurement criteria were first met for objective response (documented CR or PR) until recurrence/progression or death whatever the cause.|Baseline up to 2 years 7 months|ITT|||Months||Full Range|Median
2720522|NCT01095003|Secondary|Disease Control Rate|Disease control rate defined (DCR) as the sum of confirmed complete response, confirmed partial response and stabilisation rate.|Baseline up to 2 years 7 months|ITT population|||Percent||95% Confidence Interval|Number
2720523|NCT01095003|Secondary|Overall Response Rate (ORR)|ORR defined as documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first.|Baseline upto 2 years 7 months|ITT population|||Percent||95% Confidence Interval|Number
2720524|NCT01095003|Secondary|Overall Survival|The overall survival (OS) was defined as the duration between the date of randomisation and the date of death from any cause. The OS analysis was performed in the ITT population and the eligible and per protocol populations once the required number of events (631 deaths) was observed Patients lost to follow-up, or without a known record of death at time of analysis had the OS censored at the date of last contact.|Baseline upto 3 years 10 months|ITT population|||Months||95% Confidence Interval|Median
2720525|NCT01095003|Primary|Progression Free Survival|"PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.~The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last."|Baseline up to 2 years 7 months|ITT population|||Months||95% Confidence Interval|Median
2720526|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time|Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis|||sec*hour||Standard Deviation|Mean
2720527|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa|Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis|||IU/ml*hour||Standard Deviation|Mean
2720528|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time|Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis|||sec||Standard Deviation|Mean
2720529|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)|Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis.|||IU/ml||Standard Deviation|Mean
2720530|NCT01094808|Secondary|Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
2720768|NCT01093586|Secondary|Incidence of Chronic GVHD|Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)|At 1 year|All participants that went on study|||Participants|||Count of Participants
2720531|NCT01094808|Secondary|Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
2720532|NCT01094808|Secondary|Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
2720533|NCT01094808|Secondary|Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
2720534|NCT01094808|Secondary|Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
2720535|NCT01094808|Primary|Postprandial Motility Index Over 30 Minutes|The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]|30 minutes after the meal||||log mm Hg||Standard Deviation|Mean
2720536|NCT01094808|Primary|Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)||||Symmetric percentage change||Standard Deviation|Mean
2720537|NCT01094808|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|Approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
2720538|NCT01094808|Primary|Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure|The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
2720539|NCT01094808|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
2720540|NCT01094782|Primary|Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants|Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.|End of Week 4|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
2720541|NCT01094782|Primary|Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants|Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.|End of Week 2|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
2720769|NCT01093586|Secondary|Incidence of Acute Graft-versus-host Disease (GVHD)|Number of participants that had acute GVHD|At 100 days|All participants who went on study|||Participants|||Count of Participants
2720770|NCT01093586|Secondary|Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0|Number of participants that experienced toxicity related to the transplant|by day +42|Patients that received transplant|||Participants|||Count of Participants
2720542|NCT01094782|Primary|Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants|Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.|Start of Week 1|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
2720543|NCT01094782|Primary|Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants|Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.|End of Week 4|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
2720544|NCT01094782|Primary|Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants|Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.|End of Week 2|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
2720545|NCT01094782|Primary|Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants|Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.|Start of Week 1|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
2720546|NCT01094743|Secondary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting||||units on a scale||Standard Deviation|Mean
2720547|NCT01094743|Primary|Subjective Assessment of Quality of Vision|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear||||units on a scale||Standard Deviation|Mean
2720548|NCT01094743|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear||||eyes|eyes||Number
2720549|NCT01094743|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear||||eyes|eyes||Number
2720550|NCT01094743|Primary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear|Completed subjects|||units on a scale||Standard Deviation|Mean
2720551|NCT01094743|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 1 week of lens wear|All completed subjects|||participants|||Number
2720552|NCT01094743|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement|after 1 week of lens wear|All completed subjects|||eyes|eyes||Number
2720553|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 14|The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.|||CLUE points||Standard Error|Mean
2720554|NCT01094730|Primary|Lens Front Surface Deposits at Day 14|Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.|||dichtomized grading scale|Contact Lenses|Standard Deviation|Mean
2720555|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 7|The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.|||CLUE points||Standard Error|Mean
2720771|NCT01093586|Secondary|Immune Reconstitution|Immunodificency panel to see recovery of immune system. Number of participants that recovered.|Periodically for 2 years|Data not collected, panel not done because of funding.||||||
2720556|NCT01094730|Primary|Lens Front Surface Deposits at Day 7|Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.|||dichotomized grading scale|eyes|Standard Deviation|Mean
2720557|NCT01094717|Secondary|Number of Participants With Adverse Events|We will collect number and types of adverse events for the excimer-treated vs. sham-treated sites|12 weeks||||Participants|||Count of Participants
2720558|NCT01094717|Secondary|Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.|number of patients who achieved average lesion assessment score of 0 or 1 by the Target Plaque Sum Score (TPSS) for each arm/intervention. For the TPSS, the target plaque was assessed separately for induration, scaling, and erythema using a 6-point severity scale (0 = none and 5 = severe) and the scores were summed to produce the Target Plaque Sum Score [15-point scale; maximum (most severe) score 15].|8 weeks||||participants|||Number
2720559|NCT01094717|Primary|Change in the NPF Psoriasis Score of Plaques|mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques [higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)]|week 8||||percentage change||Standard Deviation|Mean
2720560|NCT01094704|Primary|Change in Average Mucociliary Clearance (0-90 Minutes) at 1 and 4 Hrs Post Dose (MCC4hr - MCCbaseline; MCC1hr - MCCbaseline)|Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.|1-4 hours post-dose|ITT|||Absolute % change||Standard Deviation|Mean
2720561|NCT01094574|Secondary|Change in Arbitrary Perfusion Units From Baseline During Drug Infusion|Laser Doppler images were recorded at baseline and at 2 and 3 hours after starting the drug infusion to provide measurements of peripheral blood flow as an objective measure of inflammation. Blood flow was quantified by arbitrary perfusion units. Baseline measurements were subtracted from the average measurements obtained 2 and 3 hours after starting the drug infusion.|Laser doppler images were recorded at baseline and at 2 and 3 hours after starting the drug infusion||||relative flux||Standard Deviation|Mean
2720562|NCT01094574|Secondary|IL-12 (ng/mL) Change From Baseline During Infusion|IL-12 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720563|NCT01094574|Secondary|IL-10 (ng/mL) Change From Baseline During Infusion|IL-10 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720564|NCT01094574|Secondary|IL-8 (ng/mL) Change From Baseline During Infusion|IL-8 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720565|NCT01094574|Secondary|GMCSF (ng/mL) Change From Baseline During Infusion|GMCSF (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720566|NCT01094574|Secondary|IL-6 (ng/mL) Change From Baseline During Infusion|IL-6 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720567|NCT01094574|Secondary|IL-2 (ng/mL) Change From Baseline During Infusion|IL-2 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720568|NCT01094574|Secondary|IL-1β (ng/mL) Change From Baseline During Infusion|IL-1β (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720569|NCT01094574|Secondary|TNFα (ng/mL) Change From Baseline During Infusion|TNFα (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
2720570|NCT01094574|Primary|Change From Baseline in Mechanical Pain Threshold During Infusion in Inflamed Skin|A metal rod of 0.24 mm diameter mounted onto 10 different weights (1.0, 2.0, 4.1, 8.2,16.3, 20, 32.7,49.0, 65.3, and 81.3g) will be placed perpendicularly onto the skin. Starting with the lightest probe, consecutively heavier probes will be used until a subject reports pain. Subsequently, the same or the next lighter probe will be used if pain is reported for the preceding stimulus, or the same or the next heavier probe will be used if no pain is reported for the preceding stimulus.The procedure will be repeated until seven perceptional changes (painful/non-painful) are registered. Measurements for anti-hyperalgesia were taken at the sites of tissue injury. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||weight in grams||Standard Deviation|Mean
2720571|NCT01094574|Primary|Change From Baseline in Mechanical Pain Threshold During Infusion in Non-Inflamed Skin|A metal rod of 0.24 mm diameter mounted onto 10 different weights (1.0, 2.0, 4.1, 8.2,16.3, 20, 32.7,49.0, 65.3, and 81.3g) will be placed perpendicularly onto the skin. Starting with the lightest probe, consecutively heavier probes will be used until a subject reports pain. Subsequently, the same or the next lighter probe will be used if pain is reported for the preceding stimulus, or the same or the next heavier probe will be used if no pain is reported for the preceding stimulus.The procedure will be repeated until seven perceptional changes (painful/non-painful) are registered. Measurements for analgesia were taken at the sites of non-injured skin. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||weight in grams||Standard Deviation|Mean
2720572|NCT01094574|Primary|Change From Baseline in Heat Pain Threshold During Infusion in Inflamed Skin|Degrees Centigrade Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin on the upper thigh. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature. Measurements for anti-hyperalgesia were taken at the sites of tissue injury. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||degrees centigrade||Standard Deviation|Mean
2720573|NCT01094574|Primary|Change From Baseline in Heat Pain Threshold During Infusion in Non-Inflamed Skin|Degrees Centigrade Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin on the upper thigh. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature. Measurements for analgesia were taken at the sites of non-injured skin. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||degree centigrade||Standard Deviation|Mean
2720574|NCT01094561|Secondary|The Positive Predictive Value of S-MRCP|"The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests.~Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Up to 1 year|||||||
2720772|NCT01093586|Secondary|Occurrence of Serious Infections|Number of participants that had infections|1 year|All participants that went on study|||Participants|||Count of Participants
2720575|NCT01094561|Primary|S-MRCP and S-EUS Concordance|"The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques.~Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Day 1 and up to 30 days after S-MRCP|||||||
2720576|NCT01094548|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.|From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)|Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.|||participants|||Number
2720577|NCT01094548|Secondary|Time to Anti-tumor Therapy|Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||months||95% Confidence Interval|Median
2720578|NCT01094548|Secondary|Time to Progression (TTP)|Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: >25% increase in the level of serum monoclonal paraprotein (M-protein);>25% increase in the 24 h urinary light chain excretion; >25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||months||95% Confidence Interval|Median
2720579|NCT01094548|Secondary|Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]|OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), <=5% plasma cells in bone marrow (BM); PR: >=50% reduction in serum M-protein, plasma cells in BM, size of STP; >=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: >25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||Percentage of participants|||Number
2720580|NCT01094548|Secondary|Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type|Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. “n” signifies number of participants evaluable for the particular HLA type, respectively.|||participants|||Number
2720773|NCT01093586|Secondary|Transplant Related Mortality|Number of subjects that died because of transplant|On day 180 post transplant|All participants that went on study|||Participants|||Count of Participants
2720581|NCT01094548|Secondary|Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response|Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9).|Baseline and Week 9|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||participants|||Number
2720582|NCT01094548|Primary|Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response|The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon [IFN] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell [PBMC]) with ratio to background >=2, and ratio of background-corrected value to baseline >=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS[t]=1), upon fulfilling the following criteria: Yt =>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t > AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||participants|||Number
2720583|NCT01094522|Primary|Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)||0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs||||ng/mL||Full Range|Median
2720584|NCT01094522|Secondary|•Amount of Study Drug Administered During the 24-hour Dosing Period||24 hours||||mg||Full Range|Mean
2720585|NCT01094522|Secondary|•Pain Scores (FLACC) During the 24 Hours Study Period|"Average of hourly FLACC score for each subject over 24 hours was calculated, followed by median and full range for total subjects in each arm.~FLACC (Face, Leg, Activity, Cry, Consolability) score ranges from 0-10 with 0 representing no pain"|24 hours|Hourly FLACC score was calculated for 16 subjects in Methadone group and 19 subjects in morphine group|||units on a scale||Full Range|Median
2720586|NCT01094522|Primary|Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)||0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs||||ng/mL||Full Range|Median
2720587|NCT01094301|Secondary|Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)|Subjects were asked to assess their arm impairment using the Stroke Upper Limb Capacity Scale (SULCS) test. The SULCS is a validated upper limb capacity scale which includes tasks directly related to activities of daily living individuals experience in their home environment. The SULCS consists of 10 items, with each item having a possible score of 0 or 1: 3 items for arm capacity without active hand capacity; 4 items for arm capacity and basic hand capacity; and, 3 items for complex hand capacity. These scores were summed with a higher score indicating better capacity, with 10 being the max score. The average score across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Trial Stage).|Baseline, 3-week (Trial Stage), 6-week (Trial Stage)|This survey was collected for the last 9 subjects enrolled in the Trial Stage due to a mid-study protocol change. Of these 9 subjects,6 subjects completed the survey at 3-weeks and 8 subjects completed the survey at 6-weeks.|||Scores on a scale||Standard Deviation|Mean
2720588|NCT01094301|Secondary|User Satisfaction (Implant Stage)|Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the IPG System as a method for managing post-stroke shoulder pain.|12-weeks,12-months post IPG-Stim ON (Implant Stage)||||Participants|||Count of Participants
2720589|NCT01094301|Secondary|Global Impact of Stimulation Therapy (Implant Stage)|"The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from very much worse to very much improved. The subjects combine all the components of their experience into one overall score."|3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)||||Participants|||Count of Participants
2720590|NCT01094301|Secondary|Emotional Functioning (Implant Stage)|Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.|3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)||||Scores on a scale||Standard Deviation|Mean
2720591|NCT01094301|Secondary|Pain-Free Passive Range of Motion (Implant Stage)|Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.|3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)||||Degrees||Standard Deviation|Mean
2720592|NCT01094301|Secondary|Pain Interference (Implant Stage)|"Subjects were asked to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on an 11-point numerical rating scale where 0 represents does not interfere and 10 represents completely interferes. The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim On."|3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)||||score on a scale||Standard Deviation|Mean
2720774|NCT01093586|Secondary|Transplant Related Mortality|Number of subjects that died because of transplant|On day 100 post transplant|Participants that went on study|||Participants|||Count of Participants
2720593|NCT01094301|Secondary|Quality of Life (Implant Stage)|Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months, post IPG-Stim ON were reported.|3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)||||Scores on a scale||Standard Deviation|Mean
2720594|NCT01094301|Secondary|Global Impact of Stimulation Therapy (Trial Stage)|"The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from very much worse to very much improved. The subjects combine all the components of their experience into one overall score."|3-week (Trial Stage), 6-week (Trial Stage)|One subject did not reach end of treatment and was not included in the 6-week treatment analysis.|||Participants|||Count of Participants
2720595|NCT01094301|Secondary|User Satisfaction (Trial Stage)|Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the Smartpatch Stimulation System as a method for managing post-stroke shoulder pain.|6-week (Trial Stage)|This survey was not a part of the original study design. It was administered to 21 subjects. Additionally, one subject did not answer the questions related to their study experience.|||Participants|||Count of Participants
2720596|NCT01094301|Secondary|Emotional Functioning (Trial Stage)|Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).|Baseline, 3-week (Trial Stage), 6-week (Trial Stage)|One subject did not reach end of treatment and was not included in the end of treatment analysis.|||Scores on a scale||Standard Deviation|Mean
2720597|NCT01094301|Secondary|Number of Participants Completing the Economic Impact Survey|Subjects were asked to document pain medication, doctor visits, supplies, related treatments, need for caregivers, time spent in skilled nursing facilities, and lost work due to their shoulder pain. This data was collected from subjects at Baseline and asked to recall this data for the 6-months prior to study enrollment. National average costs were not available for these data points, and therefore the overall economic impact of shoulder pain could not be reported.|Baseline||||Participants|||Count of Participants
2720598|NCT01094301|Secondary|Quality of Life (Trial Stage)|Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for Baseline, 3-week (End of Placebo), and 6-week (End of Treatment) were reported.|Baseline, 3-week (Trial Stage), 6-week (Trial Stage)|Computer analysis of the available data was not completed for four subjects at baseline, six subjects at 3-weeks, and eight subjects at end of treatment. Additionally, one subject did not reach end of treatment and was not included in the end of treatment analysis.|||Scores on a scale||Standard Deviation|Mean
2720599|NCT01094301|Secondary|Pain-Free Passive Range of Motion (Trial Stage)|Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).|Baseline, 3-week (Trial Stage), 6-week (Trial Stage);|One subject did not reach end of treatment and was not included in the end of treatment analysis.|||Degrees||Standard Deviation|Mean
2720600|NCT01094301|Secondary|Pain Interference (Trial Stage)|"Subjects were asked to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on an 11-point numerical rating scale where 0 represents does not interfere and 10 represents completely interferes. The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment)."|Baseline, 3-week (Trial Stage), 6-week (Trial Stage)|One subject did not reach end of treatment and was not included in the end of treatment analysis.|||score on a scale||Standard Deviation|Mean
2720601|NCT01094301|Primary|Number of Subjects Who Were an Implant Stage Success|Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.|12-weeks post IPG-Stim ON||||Participants|||Count of Participants
2720602|NCT01094301|Primary|Number of Subjects Who Were a Trial Stage Success|The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.|End of Treatment (EOT)|Twenty-seven subjects completed the study through end of treatment (EOT)|||Participants|||Count of Participants
2720603|NCT01094301|Primary|Device-Related Adverse Events|At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.|Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)||||Participants|||Count of Participants
2720604|NCT01094301|Primary|Pain Intensity (Implant Stage)|"Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents No Pain and 10 represents Pain as bad as you can imagine. The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON."|3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)|13 subjects were a trial stage success, 7 of which meet the eligibility criteria for the implant stage, and 5 of the subjects continued on to have the SPR IPG implanted.|||score on a scale||Standard Deviation|Mean
2720605|NCT01094301|Primary|Pain Intensity (Trial Stage)|"Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents No Pain and 10 represents Pain as bad as you can imagine. The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment)."|Baseline, 3-week (Trial Stage), 6-week (Trial Stage)|One subject did not reach end of treatment. Due to this, the subject was not included in the end of treatment analysis.|||score on a scale||Standard Deviation|Mean
2720606|NCT01094288|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as the time from first dose to first PD, or censored at last SD or better.|Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months)|Response-Evaluable population includes patients that are either RECIST-evaluable or PSA-evaluable. Here, number of participants analyzed are the participants who had SD. For a participants that has not progressed, duration of SD is censored at the last response assessment that is SD or better.|||days||Full Range|Median
2720607|NCT01094288|Secondary|Duration of Response|Duration of response is defined as the time from the date of first documentation of a response to the date of first documented progressive disease (PD), or censored at last SD or better.|Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months)|Response-Evaluable population includes patients that are either RECIST-evaluable or PSA-evaluable. Here, number of participants analyzed are the participants who were responders. A responder that did not experience disease progression were censored at the last response assessment that is SD or better.|||days||Full Range|Median
2720608|NCT01094288|Secondary|Best Overall Response Rate Assessed by PSA Response by Prostate Cancer Working Group 2 (PCWG2) Criteria|Best Response Assessed by PSA Response by Prostate Cancer Working Group 2 (PCWG2) Criteria PSA response is defined as at least 50% decrease in PSA value from baseline for 2 consecutive evaluations.|Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months)|PSA-Evaluable Population is a subset of the safety population who had a baseline PSA reference value (>5 ng/mL) and at least 12 weeks post-baseline PSA assessment for participants with no decline from baseline, or PSA progression within 12 weeks of treatment for participants with PSA decline from baseline.|||percentage of participants||95% Confidence Interval|Number
2720609|NCT01094288|Secondary|Best Overall Response Rate Assessed by RECIST Criteria|Best response rate is defined as the percentage of participants with CR, PR, CR+PR, stable disease (SD) and progressive disease (PD) as assessed by RECIST criteria 1.1 for target lesions and assessed by CT, PET or MRI. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months)|RECIST-Evaluable Population included a subset of the safety population who had measurable disease by RECIST v 1.1 at baseline and had at least 1 post baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2720610|NCT01094288|Secondary|Overall Response Rate for Prostate Cancer Participants|ORR is defined as percentage of participants who achieved CR or PR as assessed by either RECIST v 1.1 or PSA response by prostate cancer working group 2 (PCWG2) criteria. According to RECIST v 1.1, CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. PSA response by PCWG2 is defined as PSA at least 50% decrease in PSA value from baseline for 2 consecutive evaluations. PCWG2 defines PSA progression as the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.|Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months)|Response-Evaluable Population included participants who were either RECIST evaluable or PSA-evaluable. Here, number of participants analyzed are the enrolled participants who had castration-resistant prostate cancer (CRPC) and were evaluable by either RECIST or PSA response criteria.|||percentage of participants||95% Confidence Interval|Number
2720611|NCT01094288|Secondary|Overall Response Rate (ORR) Assessed for Overall Participant Population|ORR is defined as percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by response evaluation criteria in solid tumors (RECIST) v 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of longest diameter (LD) of target lesions in reference to Baseline. RECIST-Evaluable Population is subset of safety population who had measurable disease by RECIST v 1.1 at baseline and had at least 1 post baseline response. prostate specific antigen (PSA)-Evaluable Population is subset of the safety population who had a baseline PSA reference value (>5 ng/mL) and at least 12 weeks post-baseline PSA assessment for participants with no decline from baseline, or PSA progression within 12 weeks of treatment for participants with PSA decline from baseline.|Baseline up to Cycle 36 (21-day cycles) until disease progression, death or EOT (approximately up to 24.8 months)|Response-Evaluable Population included participants who were either RECIST evaluable and/or PSA-evaluable.|||percentage of participants||95% Confidence Interval|Number
2720775|NCT01093586|Secondary|Recurrence or Relapse|Number of subjects that had disease recurrence|two years post transplant|Subjects who had completed engraftment|||Participants|||Count of Participants
2720612|NCT01094288|Secondary|AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Day 7 Over the Dosing Interval for Alisertib||Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1|PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2720613|NCT01094288|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib||Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1|PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr||Full Range|Median
2720614|NCT01094288|Secondary|Cmax: Maximum Observed Plasma Concentration for Alisertib||Prior to dosing on Day 1 and Day 5 or 7 and at multiple time points (up to 12 hours) post-dose in Cycle 1|PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2720615|NCT01094288|Secondary|Terminal Phase Elimination Half-life (T1/2) for Docetaxel||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2|PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr||Standard Deviation|Mean
2720616|NCT01094288|Secondary|AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity for Docetaxel||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2|PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2720617|NCT01094288|Secondary|AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2|PK parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2720618|NCT01094288|Secondary|Cmax: Maximum Observed Plasma Concentration for Docetaxel||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Cycles 1 and 2|Pharmacokinetic (PK) parameter population was defined as all participants who had sufficient dosing data and plasma alisertib or docetaxel concentration-time data to permit the calculation of any PK parameter. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2720619|NCT01094288|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From enrollment through 30 days after the last dose of study drug (approximately up to 77 months)|Safety Population included all participants who received at least 1 dose of any study drug.|||participants|||Number
2720620|NCT01094184|Secondary|Percentage of Participants By Karnofsky Performance Status Scale Scores|Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Number Analyzed' signifies the number of participants who underwent Karnofsky Performance Status Scale Score assessment at specified time points for different arms, respectively. Data is not reported for Cycles 35, 41, 44 as no participant was evaluable at these time points.|||percentage of participants|||Number
2720621|NCT01094184|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.|Baseline up to disease progression (overall approximately 5 years and 9 months)|ITT analysis population|||months||95% Confidence Interval|Median
2720622|NCT01094184|Secondary|Percentage of Participants With Disease Progression|Disease progression was defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.|Baseline up to disease progression (overall approximately 5 years and 9 months)|ITT analysis population|||percentage of participants|||Number
2720776|NCT01093586|Secondary|Recurrence or Relapse|Number of subjects that had disease recurrence|one year in patients post UCBT|Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.|||Participants|||Count of Participants
2720623|NCT01094184|Secondary|Overall Survival|Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause. Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.|Baseline up to death (overall approximately 5 years and 9 months)|ITT analysis population|||months||95% Confidence Interval|Median
2720624|NCT01094184|Secondary|Percentage of Participants Who Died Due to Any Cause||Baseline up to death (overall approximately 5 years and 9 months)|ITT analysis population|||percentage of participants|||Number
2720625|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at End of Study|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.|||mm||Standard Deviation|Mean
2720626|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 46|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 46 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.|||mm||Standard Deviation|Mean
2720627|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 44|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 44 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.|||mm||Standard Deviation|Mean
2720628|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 42|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 42 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.|||mm||Standard Deviation|Mean
2720629|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 40|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 40 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.|||mm||Standard Deviation|Mean
2720630|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 39|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 39 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.|||mm||Standard Deviation|Mean
2720631|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 37|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 37 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.|||mm||Standard Deviation|Mean
2720632|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 36|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 36 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.|||mm||Standard Deviation|Mean
2720633|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 32|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 32 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.|||mm||Standard Deviation|Mean
2720634|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 30|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 30 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.|||mm||Standard Deviation|Mean
2720777|NCT01093586|Secondary|Disease Free|Number of participants that were disease free|At 2 years|Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.|||Participants|||Count of Participants
2720635|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 29|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 29 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.|||mm||Standard Deviation|Mean
2720636|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 28|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 28 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.|||mm||Standard Deviation|Mean
2720637|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 27|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 27 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.|||mm||Standard Deviation|Mean
2720638|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 26|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 26 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.|||mm||Standard Deviation|Mean
2720639|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 25|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 25 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.|||mm||Standard Deviation|Mean
2720640|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 24|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 24 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.|||mm||Standard Deviation|Mean
2720641|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 23|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 23 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.|||mm||Standard Deviation|Mean
2720642|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 22|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 22 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.|||mm||Standard Deviation|Mean
2720643|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 21|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 21 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.|||mm||Standard Deviation|Mean
2720644|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 20|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 20 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.|||mm||Standard Deviation|Mean
2720645|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 18|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 18 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.|||mm||Standard Deviation|Mean
2720646|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 17|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 17 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.|||mm||Standard Deviation|Mean
2720647|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 16|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 16 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.|||mm||Standard Deviation|Mean
2720648|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 15|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 15 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.|||mm||Standard Deviation|Mean
2720649|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 14|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 14 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.|||mm||Standard Deviation|Mean
2720650|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 13|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 13 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.|||mm||Standard Deviation|Mean
2720651|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 12|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 12 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.|||mm||Standard Deviation|Mean
2720652|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 11|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 11 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.|||mm||Standard Deviation|Mean
2720653|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 10|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 10 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.|||mm||Standard Deviation|Mean
2720654|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 9|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 9 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.|||mm||Standard Deviation|Mean
2720655|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 8|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 8 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.|||mm||Standard Deviation|Mean
2720656|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 7|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 7 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.|||mm||Standard Deviation|Mean
2720657|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 6|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 6 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.|||mm||Standard Deviation|Mean
2720658|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 5|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 5 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.|||mm||Standard Deviation|Mean
2720659|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 4|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 4 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.|||mm||Standard Deviation|Mean
2720660|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 3|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 3 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.|||mm||Standard Deviation|Mean
2720661|NCT01094184|Primary|Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 2 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.|||mm||Standard Deviation|Mean
2720662|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.|||units on a scale||Standard Deviation|Mean
2720663|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 46 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.|||units on a scale||Standard Deviation|Mean
2720664|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 44 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.|||units on a scale||Standard Deviation|Mean
2720665|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 42 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.|||units on a scale||Standard Deviation|Mean
2720666|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 40 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.|||units on a scale||Standard Deviation|Mean
2720667|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 39 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.|||units on a scale||Standard Deviation|Mean
2720668|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 37 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.|||units on a scale||Standard Deviation|Mean
2720669|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 36 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.|||units on a scale||Standard Deviation|Mean
2720670|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 32 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.|||units on a scale||Standard Deviation|Mean
2720671|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 30 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.|||units on a scale||Standard Deviation|Mean
2720672|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 29 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.|||units on a scale||Standard Deviation|Mean
2720673|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 28 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.|||units on a scale||Standard Deviation|Mean
2720674|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 27 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.|||units on a scale||Standard Deviation|Mean
2720675|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 26 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.|||units on a scale||Standard Deviation|Mean
2720778|NCT01093586|Secondary|Disease Free|Number of participants that were disease free|At 1 year|Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.|||Participants|||Count of Participants
2720676|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 25 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.|||units on a scale||Standard Deviation|Mean
2720677|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 24 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.|||units on a scale||Standard Deviation|Mean
2720678|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 23 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.|||units on a scale||Standard Deviation|Mean
2720679|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 22 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.|||units on a scale||Standard Deviation|Mean
2720680|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 21 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.|||units on a scale||Standard Deviation|Mean
2720681|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 20 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.|||units on a scale||Standard Deviation|Mean
2720682|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 18 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.|||units on a scale||Standard Deviation|Mean
2720683|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 17 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.|||units on a scale||Standard Deviation|Mean
2720779|NCT01093586|Secondary|Overall Survival|Number of participants that were alive.|At 2 years|Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.|||Participants|||Count of Participants
2720684|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 16 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.|||units on a scale||Standard Deviation|Mean
2720685|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 15 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.|||units on a scale||Standard Deviation|Mean
2720686|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 14 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.|||units on a scale||Standard Deviation|Mean
2720687|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 13 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.|||units on a scale||Standard Deviation|Mean
2720688|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 12 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.|||units on a scale||Standard Deviation|Mean
2720689|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 11 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.|||units on a scale||Standard Deviation|Mean
2720690|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 10 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.|||units on a scale||Standard Deviation|Mean
2720691|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 9 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.|||units on a scale||Standard Deviation|Mean
2720780|NCT01093586|Secondary|Overall Survival|Number of participants that were alive.|At 1 year|Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46.|||Participants|||Count of Participants
2720692|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 8 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.|||units on a scale||Standard Deviation|Mean
2720693|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 7 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.|||units on a scale||Standard Deviation|Mean
2720694|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 6 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.|||units on a scale||Standard Deviation|Mean
2720695|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 5 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.|||units on a scale||Standard Deviation|Mean
2720696|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 4 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.|||units on a scale||Standard Deviation|Mean
2720697|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 3 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.|||units on a scale||Standard Deviation|Mean
2720698|NCT01094184|Primary|Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 2 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.|||units on a scale||Standard Deviation|Mean
2720699|NCT01094184|Primary|Change From Baseline in FACT-B Score at End of Study|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.|||units on a scale||Standard Deviation|Mean
2720700|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 46|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 46 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.|||units on a scale||Standard Deviation|Mean
2720701|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 44|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 44 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.|||units on a scale||Standard Deviation|Mean
2720702|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 42|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 42 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.|||units on a scale||Standard Deviation|Mean
2720703|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 39|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 39 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.|||units on a scale||Standard Deviation|Mean
2720704|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 37|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 37 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.|||units on a scale||Standard Deviation|Mean
2720705|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 36|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 36 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.|||units on a scale||Standard Deviation|Mean
2720706|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 32|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 32 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.|||units on a scale||Standard Deviation|Mean
2720707|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 30|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 30 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.|||units on a scale||Standard Deviation|Mean
2720763|NCT01093625|Primary|Limbal Hyperemia|Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
2720708|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 29|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 29 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.|||units on a scale||Standard Deviation|Mean
2720709|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 28|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 28 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.|||units on a scale||Standard Deviation|Mean
2720710|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 27|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 27 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.|||units on a scale||Standard Deviation|Mean
2720711|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 26|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 26 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.|||units on a scale||Standard Deviation|Mean
2720712|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 25|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 25 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.|||units on a scale||Standard Deviation|Mean
2720713|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 24|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 24 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.|||units on a scale||Standard Deviation|Mean
2720714|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 23|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 23 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.|||units on a scale||Standard Deviation|Mean
2720715|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 22|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 22 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.|||units on a scale||Standard Deviation|Mean
2720764|NCT01093625|Primary|Conjunctival Hyperemia|Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
2720716|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 21|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 21 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.|||units on a scale||Standard Deviation|Mean
2720717|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 20|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 20 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.|||units on a scale||Standard Deviation|Mean
2720718|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 18|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 18 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.|||units on a scale||Standard Deviation|Mean
2720719|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 17|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 17 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.|||units on a scale||Standard Deviation|Mean
2720720|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 16|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 16 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.|||units on a scale||Standard Deviation|Mean
2720721|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 15|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 15 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.|||units on a scale||Standard Deviation|Mean
2720722|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 14|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 14 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.|||units on a scale||Standard Deviation|Mean
2720723|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 13|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 13 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.|||units on a scale||Standard Deviation|Mean
2720765|NCT01093625|Primary|Papillary Conjunctivitis|Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
2720724|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 12|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 12 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.|||units on a scale||Standard Deviation|Mean
2720725|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 11|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 11 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.|||units on a scale||Standard Deviation|Mean
2720726|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 10|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 10 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.|||units on a scale||Standard Deviation|Mean
2720727|NCT01094184|Primary|Change From Baseline in FACT-B Score At Cycle 9|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 9 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.|||units on a scale||Standard Deviation|Mean
2720728|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 8|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 8 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.|||units on a scale||Standard Deviation|Mean
2720729|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 7|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 7 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.|||units on a scale||Standard Deviation|Mean
2720730|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 6|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 6 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.|||units on a scale||Standard Deviation|Mean
2720731|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 5|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 5 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.|||units on a scale||Standard Deviation|Mean
2720766|NCT01093599|Secondary|Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls||6 months post quit day|||||||
2720767|NCT01093599|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.|6 months post quit day|intent to treat analysis|||participants|||Number
2720781|NCT01093586|Secondary|Hematologic Engraftment|Number of participants that were able to complete engraftment by day 42.|On day +42|Participants that went on study.|||Participants|||Count of Participants
2720732|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 4|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 4 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.|||units on a scale||Standard Deviation|Mean
2720733|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 3|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 3 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.|||units on a scale||Standard Deviation|Mean
2720734|NCT01094184|Primary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 2 (Cycle length=2 and 3 weeks)|Intent-to-treat (ITT) analysis population included all participants who received at least 1 dose of all study medication (taxane and bevacizumab). 'Overall Number of Participants Analyzed'=participants who completed the questionnaire at Baseline; 'Number Analyzed'=participants who completed the questionnaire at Baseline and at specified time point.|||units on a scale||Standard Deviation|Mean
2720735|NCT01094171|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Month 4)||||Subjects|||Number
2720736|NCT01094171|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0 - 30) post vaccination period||||Subjects|||Number
2720737|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.|During the 4-day (Days 0 - 3) post vaccination period||||Subjects|||Number
2720738|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)|During the 4-day (Days 0 - 3) post vaccination period||||Subjects|||Number
2720739|NCT01094119|Secondary|Proportion of Patients With Temperatures Above 36 Degree|Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery|at the end of surgery|Enrolled patients|||Participants|||Count of Participants
2720740|NCT01094119|Primary|Time Weighted Average Core Temperature|Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation|from tracheal intubation to 3 hours after or tracheal extubation|Randomized patients.|||Degrees C||Standard Deviation|Mean
2720741|NCT01093976|Primary|Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score|The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.|Subjects were followed for their duration of participation in the study (12-weeks)|Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
2720742|NCT01093885|Secondary|Systemic Sclerosis Quality of Life Assessed by the SF-36.|The SF-36 form is a patient reported survey of patient health. The comparison status was analyzed between baseline and 12 months. The SF-36 has a range of 0-100 with higher numbers suggestive of better patient health|Baseline vs Month 12.|15 subjects enrolled, 5 subjects withdrew. Data analyzed was only for the 10 subjects who completed the 12 month visit and had both a baseline and a 12 month SF-36 form completed|||units on a scale||Standard Deviation|Mean
2720743|NCT01093885|Primary|The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the MRSS|Using validated clinical response measurements such as the modified Rodnan skin score (MRSS) we will determine whether combination therapy will effect morbidity in systemic sclerosis. The modified Rodnan skin score has a range from 0-51 with higher numbers being worse skin involvement.|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2720744|NCT01093846|Primary|The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.|The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .|62 weeks|||||||
2720745|NCT01093794|Primary|Cmax for Sitagliptin and Metformin|Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.|||ng/mL||Standard Deviation|Mean
2720746|NCT01093794|Primary|Area Under the Curve (AUC(0-t)) for Sitagliptin|AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.|||hr*ng/mL||Standard Deviation|Mean
2720747|NCT01093755|Primary|Change in Esophageal Inflammation Biomarker COX-2 Gene Expression|Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.|3 months, 6 months||||% of tubulin||Standard Deviation|Mean
2720748|NCT01093755|Primary|Change in Inflammation Biomarker Tissue PGE2 Level|Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay|3 months, 6 months||||nanograms/gram of tissue||Standard Deviation|Mean
2720749|NCT01093690|Secondary|Toxicities and Severity of Nausea and Vomiting||5 days after receiving chemotherapy|||||||
2720750|NCT01093690|Primary|Number of Patients Who Had Complete Response|number of patients who experience no emesis and need no rescue treatment in 5-day period|5 days after receiving chemotherapy|intention to treat|||participants|||Number
2720751|NCT01093651|Secondary|Self-reported Symptoms|Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)|Monthly for 4 months|Cumulative frequency over 16 weeks of any self-reported symptoms on the DAIDS scale|||total number of self reported symptoms|||Number
2720752|NCT01093651|Secondary|Oral Glucose Tolerance|Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.|Baseline, week 8, week 16||||mg*min/mL||Standard Deviation|Mean
2720753|NCT01093651|Secondary|RANTES; Serum Biomarkers of Immune Activation|serum Regulated on Activation, Normal T cell Expressed and Secreted concentration|Baseline, week 8, week 16|RANTES|||ng/mL||Standard Deviation|Mean
2720754|NCT01093651|Secondary|SDF1α; Serum Biomarkers of Immune Activation|serum stromal cell-derived factor-1α concentration|Baseline, week 8, week 16|SDF1α|||pg/mL||Standard Deviation|Mean
2720755|NCT01093651|Secondary|Soluble TNFR2; Serum Biomarkers of Immune Activation|serum soluble tumor necrosis factor receptor-2 concentration|Baseline, week 8, week 16|sTNFR2|||pg/mL||Standard Deviation|Mean
2720756|NCT01093651|Primary|Plasma HIV Viremia (Viral Load)|Percentage of participants with plasma HIV RNA copy number less than 48 copies/mL|Monthly for 6 months||||percentage of participants below 48 c/mL|||Number
2720757|NCT01093651|Primary|CD4+ T-cell Count||Monthly for 4 months|CD4+ T-cell count|||cells/µL||Standard Deviation|Mean
2720758|NCT01093625|Secondary|Comfortable Wearing Time|Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.|||Hours||95% Confidence Interval|Least Squares Mean
2720759|NCT01093625|Primary|Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
2720760|NCT01093625|Primary|Corneal Neovascularization|New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
2720761|NCT01093625|Primary|Conjunctival Staining|Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
2720762|NCT01093625|Primary|Corneal Staining|Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||Efron Scale (0.1 Unit increments)||95% Confidence Interval|Least Squares Mean
2720783|NCT01093534|Secondary|Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'.~Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||percentage of participants|||Number
2720784|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.|||pg/µmol||Standard Deviation|Mean
2720785|NCT01093534|Secondary|Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF); LOCF was used.|||pg/µmol||Standard Deviation|Mean
2720786|NCT01093534|Secondary|Change From Baseline in Health-Related Quality of Life (HRQL)|"Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from 'none of the time' (1) to 'all of the time' (6).~The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720787|NCT01093534|Secondary|Change From Baseline in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6).~The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720788|NCT01093534|Secondary|Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale|"The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS).~Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720789|NCT01093534|Secondary|Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D|"The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform).~Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems.~Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data.|||percentage of participants|||Number
2720790|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Treatment Satisfaction|The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720791|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Urgency Bother|"The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line.~A negative change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720792|NCT01093534|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720793|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urgency Score|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720794|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Level of Urgency|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2720795|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 4 urgency incontinence events at Baseline and with available data; LOCF was used.|||urgency incontinence episodes||Standard Deviation|Mean
2720796|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 3 or 4 urgency incontinence events at Baseline and with available data; LOCF was used.|||urgency incontinence episodes||Standard Deviation|Mean
2720797|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set participants with incontinence events at Baseline and with available data; LOCF was used.|||incontinence episodes||Standard Deviation|Mean
2720798|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours|"An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full Analysis Set participants with urgency micturitions at Baseline and with available data; LOCF was used.|||urgency micturitions||Standard Deviation|Mean
2720799|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||micturitions||Standard Deviation|Mean
2720800|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits."|12 weeks|Full analysis set participants with events at Baseline and with available data; LOCF was used.|||urgency events||Standard Deviation|Mean
2721189|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation|The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.|Baseline to Week 12.|FAS. Starting dose of ARICEPT was not summarized.|||participants|||Number
2720801|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours|The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||events||Standard Deviation|Mean
2720802|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline, Week 6 and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data at each time point (indicated by n).|||pg/µmol||Standard Deviation|Mean
2720803|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline, Week 6 and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data at each time point (indicated by n).|||mm||Standard Deviation|Mean
2720804|NCT01093534|Secondary|Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF): all randomized participants who received at least 1 dose of randomized study medication, who had given consent for additional analysis and who had an uBDNF/Cr measurement at baseline and on at least 1 visit thereafter. LOCF was used.|||pg/µmol||Standard Deviation|Mean
2720805|NCT01093534|Secondary|Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.|||pg/µmol||Standard Deviation|Mean
2720806|NCT01093534|Primary|Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0): all randomized participants who received at least 1 dose of randomized study medication and who had an uNGF/Cr measurement at Baseline and on at least 1 visit thereafter, excluding participants with Baseline uNGF below or equal to the laboratory quantification limit. LOCF was used.|||pg/µmol||Standard Deviation|Mean
2720807|NCT01093534|Primary|Change From Baseline to Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT): all randomized participants who received at least 1 dose of randomized study medication and who had a mean BWT measurement at Baseline. Analysis includes participants with available data; Last observation carried forward (LOCF) of post-baseline data was used for imputation of missing values.|||mm||Standard Deviation|Mean
2720808|NCT01093521|Primary|Number of Events When Study Drug Infusion Was Stopped Early|Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion|6 days from starting dose||||Number of times study drug interupted|||Number
2720809|NCT01093521|Primary|Number of Serious Adverse Events|Safety as measured by serous adverse events|56 days from starting dose|ITT|||Serious Adverse Events|||Number
2720810|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 56|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56|56 days from starting dose|All available specimens|||colony counts in millions per gm sputum||Standard Deviation|Mean
2720811|NCT01093521|Secondary|Change in Sputum P. Aeruginosa Density From Baseline to Day 15|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15|15 days from starting dose||||colony counts in millions per gm sputum||Standard Deviation|Mean
2720812|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 8|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8|8 days from starting dose|All available specimens|||colony counts in millions per gm sputum||Standard Deviation|Mean
2720813|NCT01093521|Secondary|Change in Spirometry as Measured by FVC From Baseline to Day 8|Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8|8 days from starting dose||||liters||Standard Deviation|Mean
2720814|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 56|Change in lung function as measured by FEV1 in liters from baseline to day 56|56 days from starting dose|all those subjects enrolled after the amendment to add a day 56 (ITT)|||liters||Standard Deviation|Mean
2720815|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 28|Change in lung function as measured by FEV1 in liters from baseline to day 28|28 days from starting dose||||liters||Standard Deviation|Mean
2720816|NCT01093521|Secondary|Change in Lung Function From Baseline to Day 15|Change in FEV1 in liters from baseline to day 15|15 days from starting dose||||liters||Standard Deviation|Mean
2720817|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 8|Change in spirometry as measured by FEV1 in liters from baseline to day 8|8 days|ITT|||liters||Standard Deviation|Mean
2721202|NCT01089556|Other Pre-specified|Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint||Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).|||participants|||Number
2720818|NCT01093521|Primary|Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)|"To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day."|Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28||||ug*hr/mL||Standard Deviation|Mean
2720819|NCT01093482|Primary|All-cause Mortality|Mortality at discharge from intensive care unit|At day 28 after the beginning of mechanical ventilation||||Participants|||Count of Participants
2720820|NCT01093469|Primary|Investigator Global Assessment of Improvement|"This measures the overall response to treatment and quantifies disease on a 6 point scale from completely clear to worsening of disease.0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse"|Day 21||||units on a scale||Standard Error|Median
2720821|NCT01093417|Secondary|Change in Serum 25-hydroxyvitamin D Concentration in Both Groups||Baseline and 12 weeks||||ng/mL||Inter-Quartile Range|Median
2720822|NCT01093417|Primary|Change in Endothelial Function|Endothelial function measured by flow mediated brachial artery dilation|Baseline and 12 weeks||||percent change in endothelial function||Inter-Quartile Range|Median
2720823|NCT01093222|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2720824|NCT01093222|Secondary|Objective Response|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients who began protocol therapy|||percentage of participants||95% Confidence Interval|Number
2720825|NCT01093222|Primary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy|||months||95% Confidence Interval|Median
2720826|NCT01093222|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy|||months||95% Confidence Interval|Median
2720827|NCT01093183|Secondary|Overall Survival||Up to 4 years||||months||95% Confidence Interval|Median
2720828|NCT01093183|Secondary|Proportion of Patients Achieving CR||At 4 months||||Participants|||Count of Participants
2720829|NCT01093183|Secondary|Anti-tumor Activity as Assessed by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)|As measured by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1), in which CR is defined as disappearance of target lesions and a partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions. PD is defined as 20% increase over smallest sum on study (including baseline if that is smallest) and at least 5 mm increase or new lesions. SD is defined as not enough response to be PR and not enough progression to be PD.|Up to 4 months|Of the 22 subjects evaluable, three patients did not complete 2 cycles of therapy to reassess or response evaluation.|||Participants|||Count of Participants
2720830|NCT01093183|Secondary|Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria||4 weeks||||Participants|||Count of Participants
2720831|NCT01093183|Primary|Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I)|Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.|28 days||||mg|||Number
2720832|NCT01093027|Secondary|Tremor Rating Scale|Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.|After 10 minutes of limb cooling treatment.||||units on a scale||Standard Deviation|Mean
2720833|NCT01093027|Primary|Tremor Amplitude|Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.|After 10 minutes of limb cooling treatment.||||cm/s^2||Standard Deviation|Mean
2720834|NCT01093014|Primary|Skeletal Muscle Gene Expression: PPARGC1A|Messenger ribonucleic acid (mRNA) expression fold-change for peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PPARGC1A). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.|||fold-change||Standard Deviation|Mean
2721251|NCT01089231|Secondary|Blood Lipids|Fasting venous blood samples were collected and blood lipid levels were determined by an external contract laboratory (LADR, Hannover; Germany) at baseline (t0), after one week (t1) and after 12 weeks (t12) of supplementation.|baseline and after 12 weeks||||mg/dl||Standard Deviation|Mean
2720835|NCT01093014|Primary|Skeletal Muscle Gene Regulation: MSTN|Messenger ribonucleic acid (mRNA) expression fold-change for myostatin (MSTN). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.|||fold-change||Standard Deviation|Mean
2720836|NCT01093014|Primary|LF Muscle Force|Muscle force evoked during low-force muscle stimulation|up to 1 year||||N (newtons)||Standard Deviation|Mean
2720837|NCT01093014|Primary|HF Muscle Force|Muscle force evoked during high-force muscle stimulation|up to 1 year||||Newtons (N)||Standard Deviation|Mean
2720838|NCT01092923|Primary|PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)|Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)|Baseline, 2 minutes, and 5 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.|||ratio||Standard Deviation|Mean
2720839|NCT01092923|Secondary|Time to Eye Opening|The time to eye opening to command after cessation of inhalational anaesthetic administration|20 Minutes||||Minutes||Standard Deviation|Mean
2720840|NCT01092923|Primary|Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)|Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)|Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.|||ratio||Standard Deviation|Mean
2720841|NCT01092910|Secondary|Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition|"The Quick-SIN is a test of sentence recognition in varying levels of background noise. The score achieved is termed SNR loss, and a higher score indicates poorer performance on the test. SNR Loss is defined as the dB increase in signal-to-noise ratio required by a hearing-impaired person to understand speech in noise, compared to someone with normal hearing. (The range of possible scores is -4.5 to 25.5, with lower scores indicating better performance.) For this study, baseline scores for each subject are subtracted from 4 month scores, providing a difference score. The mean difference across subjects is reported here, with 0 meaning no change and a negative difference indicating better performance with Esteem, compared to the pre-implant aided condition."|4 Months Post Activation||||score on a scale||Standard Error|Mean
2720842|NCT01092910|Secondary|Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant|For each subject, the 4-month post-activation Air Conduction PTA (average of thresholds at three frequencies: 500, 1000, and 2000 Hz) was compared to the baseline unaided PTA. A negative mean difference (in dB) from baseline indicates improved hearing sensitivity with the Esteem, relative to baseline.|4 Months Post Activation||||dB||Standard Error|Mean
2720843|NCT01092910|Secondary|Scores on Esteem Questionnaire|"To gain subject feedback on the use of the Esteem System relative to their pre-implant hearing aid (aided condition) as shown by the (unvalidated) Esteem Questionnaire. Subjects completed a 7-item questionnaire rating various subjective attributes concerning their experience with Esteem as compared to their previous hearing aid. Ratings were on a scale of 1 to 5, where 1 is much worse, 3 is the same and 5 is much better. Reported here are proportions of participants responding to each score (1 to 5) on the scale, for average scores across all 7 items for each subject."|4 and 10 Months Post Activation||||Participants|||Count of Participants
2720844|NCT01092910|Secondary|Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score|"To assess whether the Esteem System improves Quality-of-Life, when compared to the baseline aided condition (pre-implant) as shown by the global Abbreviated Profile of Hearing Aid Benefit (APHAB) score. The APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication in various everyday situations using a scale ranging from 0 to 100, with higher scores indicating less difficulty (or increased benefit). The Global Score is the average of 3 subscales.~Scores reported here are calculated by comparing the patient's reported difficulty in the baseline unaided condition with their amount of difficulty when using amplification (hearing aids or implant) -- i.e. Global Scores at pre-implant baseline subtracted from scores at aided baseline and at 4 and 10 months post-implant. Positive numbers denote increased benefit relative to unaided baseline, and the higher the number, the greater the benefit."|4 and 10 Months Post-Activation|Data from entire subject cohort not available.|||score on a scale||Standard Error|Mean
2720845|NCT01092910|Primary|Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds.|Comparison of bone conduction thresholds at the 4-month and 10-month post-activation follow-up, relative to the pre-implant baseline bone conduction thresholds. Lower thresholds represent better (more sensitive) outcomes.|Baseline, 4-, and 10-Months Post-Activation|4-month and 10-month BC PTA (average 500, 1kHz, 2kHz) compared to baseline BC PTA|||dB HL||Standard Error|Mean
2720846|NCT01092910|Primary|SADEs|The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements|10 Months Post-Activation|Includes all events, cumulatively, from enrollment through 10-month followup|||events|||Number
2720847|NCT01092910|Primary|Word Recognition Score Change|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|10 Months Post Activation||||change in % correct||Standard Error|Mean
2720848|NCT01092910|Primary|Word Recognition Score Change|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|4 Months Post Activation||||change in % correct||Standard Error|Mean
2720849|NCT01092910|Primary|SRT Change|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|10 Months Post-Activation||||dB||Standard Error|Mean
2720850|NCT01092910|Primary|SRT Change|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|4 Months Post Activation||||dB||Standard Error|Mean
2720853|NCT01092832|Secondary|Percentage of Participants With a Global Response of Success at End of Treatment (EOT)|Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.|EOT (from 7 to 42 days of treatment)|Modified Intent-to-Treat (MITT) Population: all participants who received at least 1 dose of study medication and who have confirmed ICC, EC or participants with EC who do not have confirmation of EC by esophagoscopy, but who had at least confirmation of oropharyngeal candidiasis.|||percentage of participants||95% Confidence Interval|Number
2720854|NCT01092832|Primary|Percentage of Participants With Adverse Events - Overall Summary|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.|Baseline up to 1 month follow-up|Safety population|||percentage of participants|||Number
2720855|NCT01092780|Secondary|Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Meters||90% Confidence Interval|Least Squares Mean
2720856|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Minutes||95% Confidence Interval|Least Squares Mean
2720857|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Minutes||95% Confidence Interval|Least Squares Mean
2720858|NCT01092780|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.|Up to 36 days|All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2720859|NCT01092780|Primary|Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Meters||95% Confidence Interval|Least Squares Mean
2720860|NCT01092780|Primary|Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The Per-Protocol (PP) population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Minutes||95% Confidence Interval|Least Squares Mean
2720861|NCT01092767|Primary|All-cause Mortality Within 30-days of the Index Procedure||30 days||||participants|||Number
2720862|NCT01092728|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress.|Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years|None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study.|||Weeks||Full Range|Median
2720892|NCT01092559|Primary|Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.|"Adverse Event Severity [through Day 30 Follow-Up Period]~Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period]~Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin.~[through discharge from Treatment Period]~Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]"|through Day 30 Follow-up Period||||participants|||Number
2720863|NCT01092728|Primary|Biologic Response Evaluation of Tumors With and Without Resectable Tumors|"Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, >/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without >15% increase in tumoral Ki-67 expression or >/=25% decrease in tumoral Ki-67 expression without >15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): >/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image & adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background.~PR or CR confirmatory disease assessment performed >4 weeks (28 days) after criteria for response first met."|Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards|Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal).|||participants|||Number
2720864|NCT01092702|Primary|Biochemically Confirmed Abstinence From Smoking|The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.|12 weeks from start of medication||||participants|||Number
2720865|NCT01092676|Primary|Change in Visual Analog Scale (VAS) for Disability|0-10 Visual Analog Scale with 0 being no disability and 10 being severe disability. Patients are asked to place a line on the VAS to where they believe their disability to be. The final outcome is then measured in mm from 0 to the line placed by the patient.|4 days||||mm||Standard Deviation|Mean
2720866|NCT01092676|Primary|Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline|Change in Pain Scale 0-10 Visual Analog Scale with 0 being no pain and 10 being unbearable pain. Outcome is measured in mm as measured from 0 to where the participant places indicated their pain to be on the scale.|4 days||||mm||Standard Deviation|Mean
2720867|NCT01092663|Secondary|Postprandial Glucagon (AUC)|To evaluate the effects of treatment on postprandial glucagon (AUC)|Baseline and 12 weeks||||picograms (pg)/milliter (ml) x min||Standard Deviation|Mean
2720868|NCT01092663|Secondary|Postprandial Total GIP (AUC)|To evaluate the effects of treatment on postprandial total GIP (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
2720869|NCT01092663|Secondary|Postprandial Active GLP-1 (AUC)|To evaluate the effects of treatments on postprandial active GLP-1 (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
2720870|NCT01092663|Secondary|Postprandial C-peptide (AUC)|To evaluate the effect of treatments on postprandial C-peptide (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
2720871|NCT01092663|Secondary|Postprandial Insulin (AUC)|To evaluate the effect of treatments on postprandial insulin (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
2720872|NCT01092663|Secondary|Fasting Insulin|To evaluate the effect of treatments on fasting insulin concentrations|Baseline and 12 weeks||||pmol/L||Standard Deviation|Mean
2720873|NCT01092663|Primary|Postprandial Glucose (AUC)|Comparison between baseline and 12 weeks values of postrandial glucose (AUC).|Baseline and 12 weeks||||millimoles (mmol)/l x min||Standard Deviation|Mean
2720874|NCT01092663|Primary|Whole-body Glycolytic Disposal of Oral Glucose|Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments|baseline and 12 weeks||||Percent of Load||Standard Deviation|Mean
2720875|NCT01092663|Primary|Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)|"Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments~AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test."|baseline and 12 weeks||||umol per kg per min||Standard Deviation|Mean
2720876|NCT01092663|Primary|Postprandial Endogenous Glucose Production|"Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments~Mean value was calculated using all results measured between 10 and 300 min post meal."|baseline and 12 weeks||||umol per kg per min||Standard Deviation|Mean
2720877|NCT01092663|Primary|Appearance Rate of Oral Glucose|Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments|baseline and 12 weeks||||umol per kg per min||Standard Deviation|Mean
2720878|NCT01092663|Primary|Fasting Plasma Glucose Clearance|Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.|baseline and 12 weeks||||ml per kg FFM per minute (min)||Standard Deviation|Mean
2720879|NCT01092663|Primary|Fasting Glycogenolysis|Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks||||umol per kg Fat-Free Mass (FFM) per min||Standard Deviation|Mean
2720880|NCT01092663|Primary|Fasting Gluconeogenesis|Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks||||umol per kilogram (kg) FFM per min||Standard Deviation|Mean
2720881|NCT01092663|Primary|Fasting Endogenous Glucose Production|Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks||||micromoles (umol) per kg FFM per min||Standard Deviation|Mean
2720882|NCT01092663|Secondary|Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)|To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.|Baseline and 12 weeks||||pmol/L||Standard Deviation|Mean
2720883|NCT01092663|Secondary|Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)|To evaluate the effect of treatments on plasma GLP-1 concentrations.|Baseline and 12 weeks||||pmol/L||Standard Deviation|Mean
2720884|NCT01092663|Secondary|Fasting Plamsa Glucagon|To evaluate the effect of treatments on plasma glucagon concentrations.|Baseline and 12 weeks||||picograms (pg)/milliliter (ml)||Standard Deviation|Mean
2720893|NCT01092546|Secondary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Pons as the Reference Region."|The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.|Post flutemetamol administration|"The correlation coefficient listed in the table is between SUVR-Pons and the percent area of Amyloid.~Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the Pons as the reference region."|||Correlation Coefficient of the site|||Number
2720894|NCT01092546|Primary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Cerebellum (CER) as the Reference Region."|The level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.|Post flutemetamol Injection|"The correlation coefficient listed in the table is between SUVR-CER and the percent area of Amyloid.~Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the cerebullum (CER) as the reference region."|||Correlation Coefficient of the Site|||Number
2720895|NCT01092507|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)|"Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.~Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable."|Day 0 through Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).|||Participants|||Number
2720896|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)|||Titers||95% Confidence Interval|Geometric Mean
2720897|NCT01092507|Secondary|Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)|||Participants|||Number
2720898|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Titers||95% Confidence Interval|Geometric Mean
2720899|NCT01092507|Secondary|Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination."|Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Participants|||Number
2720900|NCT01092507|Secondary|Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 post-vaccination|Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Participants|||Number
2720901|NCT01092507|Primary|Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50).~Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination."|Day 0 through Day 28 after vaccination|Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Participants|||Number
2720919|NCT01091948|Secondary|Occurrence of Hypoxaemia|Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.|at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after||||participants|||Number
2720902|NCT01092442|Primary|Safety Assessment|"Evaluation of the following adverse events~Mortality (all cause and valve-related)~Reoperation/reintervention~Explant~Endocarditis~Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)~Thrombosis~Thromboembolism (pulmonary embolism)~Non-structural dysfunction~Perivalvular leak~Bleeding~Hemolysis~Calcification"|Since Implant of the Valve to a Maximum of 13.0 years||||percentage of patients|||Number
2720903|NCT01092442|Primary|Hemodynamic Performance|Pulmonary Insufficiency Grade|Most Recent Follow-up (average of 4 to 6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.|||participants|||Number
2720904|NCT01092442|Primary|Hemodynamic Performance|Peak Pulmonary Gradient Mean Pulmonary Gradient|Most Recent follow-up (average of 3-6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.|||mmHg||Standard Deviation|Mean
2720905|NCT01092416|Primary|Primary Efficacy Endpoint: Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.||||Percentage of procedures||95% Confidence Interval|Number
2720906|NCT01092416|Secondary|12-Month Freedom From Major Adverse Cardiac Events (MACE)|The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.|12 months|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 12 months.|||Percent probability of Freedom from MACE||95% Confidence Interval|Number
2720907|NCT01092416|Secondary|Severe Angiographic Complications|Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.|Baseline procedure, with a mean total procedure time of 52.5 minutes.||||Participants|||Number
2720908|NCT01092416|Secondary|Angiographic Success|Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.|Baseline procedure, with a mean total procedure time of 52.5 minutes.||||Percentage of procedures|||Number
2720909|NCT01092416|Primary|Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)|"OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of:~Cardiac death.~MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave.~TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure."|30 days|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.|||Percent probability of Freedom from MACE||95% Confidence Interval|Number
2720910|NCT01092364|Primary|Change in Body Weight||Baseline and 24 months|Intention to treat|||kg||Standard Deviation|Mean
2720911|NCT01092338|Primary|Efficacy of the Two Doses (4000 and 7000 IU/d)|Daily D3 supplementation will result in 25D >= to 32/ng/ml|12 weeks|Number of subjects with serum 25D concentration levels >= 32 ng/ml after 12 weeks of supplementation.|||participants|||Number
2720912|NCT01092338|Primary|Safety|Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).|12 weeks|Number of subjects with elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml)|||participants|||Number
2720913|NCT01092195|Primary|Percentage of Subjects Who Developed Antibody Response to the Vaccine.|The percentage of subjects who developed antibody response to the quadrivalent HPV (qHPV) vaccine (HPV - 6/ - 11/ - 16/ - 18). Anti-HPV-6/11/16/18-specific antibody responses using L1 Virus Like Particle (VLP) ELISA were measured in serum.|12 months||||Participants|||Count of Participants
2720914|NCT01091974|Secondary|Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .|"The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue now, and fatigue at its worst and usual for the last 24 hours. The 11-point scales are bounded by 0 = no fatigue and 10 = fatigue as bad as you can imagine. Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = does not interfere and 10 = interferes completely. A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI."|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).|Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.|||units on a scale||Standard Error|Mean
2720915|NCT01091974|Primary|Change in Insomnia Severity Index From Baseline to Post-intervention|The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).||||units on a scale||Standard Error|Mean
2720916|NCT01091948|Secondary|Number of Intubation Attempts||from start of intubation to successfully intubated||||participants|||Number
2720917|NCT01091948|Secondary|Sore Throat Grade||On the first postoperative day|This outcome was not collected for 1 patient in each group.|||participants|||Number
2720918|NCT01091948|Secondary|Trace Bleeding|Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube|Right after intubation||||participants|||Number
2720920|NCT01091948|Secondary|Successful Intubation on 1st Attempt||from start of first intubation to end of first intubation attempt||||participants|||Number
2720922|NCT01091948|Primary|Time to Intubation (TTI) as Measured in Seconds|Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).|from start of intubation to successfully intubated up to 100 seconds||||seconds||Inter-Quartile Range|Median
2720923|NCT01091675|Primary|the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined|"BASDAI Bath Ankylosing Spondylitis Disease Activity Index, is the gold standard for measuring and evaluating disease activity in Ankylosing Spondylitis consists of a one through 10 scale which is used to answer 6 questions pertaining to the 5 major symptoms of AS.~BASDAI has been used to assess the efficacy of the treatment. Possible Patients were considerate respond to ASABIO criteria when presented a change of 2 in the BASDAI score range."|the ASAS response were evaluated at week 2 and 4 and after 6 months treatment|Patients with physician-diagnosed Ankylosing Spondylitis at 6 months before study start|||percentage of participants||95% Confidence Interval|Number
2720924|NCT01091662|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Double-blind: week to 18; Baseline: weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 54; Baseline: 54; Titration: 54; AED taper/conversion; 54; Monotherapy: 48 (ESL 1600 mg) Double-blind: 100; Baseline: 98; Titration: 100; AED taper/conversion; 100; Monotherapy: 88|||seizures in 28 days||Standard Deviation|Mean
2720925|NCT01091662|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population|||Percent of particiants|||Number
2720926|NCT01091662|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Week 0 to Week 18|ITT population|||percentage of participants|||Number
2720927|NCT01091662|Secondary|Proportion (%) of Subjects With Increase of Body Weight >= 7% From Baseline||18 Week Double-blind treatment period|ITT population|||percentage of participants|||Number
2720928|NCT01091662|Secondary|Change in Total Score of MADRS From Baseline in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, higher score indicates more severe|Week 0 to Week 18, baseline:day 0;end of AED taper/conversion period; end of week 8; end of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 7; Change from baseline to end of monotherapy period: 7 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 16; Change from baseline to end of monotherapy period: 18|||units on a scale||Standard Deviation|Mean
2720929|NCT01091662|Secondary|Change in Total Score in Montgomery-Asberg Depression Rating Scale (MADRS),From Baseline .|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, high score indicates more severe|Week 0 to Week 18,baseline day 0; end of AED taper/conversion period; end of week 8; end of monotherapy period; end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 48; Change from baseline to end of monotherapy period: 54 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 88; Change from baseline to end of monotherapy period: 98|||units on a scale||Standard Deviation|Mean
2720930|NCT01091662|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, Baseline: Day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period:50 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 85; Change from baseline to end of monotherapy period:96|||units on a scale||Standard Deviation|Mean
2720931|NCT01091662|Secondary|Proportion (%) of Subjects Reaching Each Exit Criteria|"The proportion (%) of subjects reaching each of the 5 exit criteria-1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.~5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|Week 1 to Week 18, (beginning of week 1 to end of week 18)|Efficacy population|||percentage of participants|||Number
2720932|NCT01091662|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double-blind weeks 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
2720933|NCT01091662|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18|Efficacy population (ESL 1200mg) Double-blind: 54; Titration: 54; AED taper/conversion:54; Monotherapy: 48 (ESL1600 mg) Double-blind:98; Titration: 98; AED taper/conversion: 98; Monotherapy: 87|||Percent change||Inter-Quartile Range|Median
2721692|NCT01085045|Secondary|Time to Onset of Action >=10% Improvement in FEV1 on Day 1|Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%|Day 1|MITT Population - not including the 4 sentinel patients.|||Participants|||Number
2720934|NCT01091662|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|Efficacy population|||days||95% Confidence Interval|Median
2720935|NCT01091662|Secondary|Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete).|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Week 8 through 18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
2720936|NCT01091662|Secondary|Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment).|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|18 weeks|Efficacy population|||percentage of participants||95% Confidence Interval|Number
2720937|NCT01091662|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Percentage of participants that were Seizure-free during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Week 15 through 18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
2720938|NCT01091662|Secondary|Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Week 9 through 18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
2720939|NCT01091662|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|"Cumulative exit rate was defined as the proportion of subjects meeting at least one of the following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.~5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|From beginning of Week 3 to end of Week 18|Efficacy population|||proportion of participants||95% Confidence Interval|Number
2720940|NCT01091519|Secondary|Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4|"Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: overall how satisfied are you with your over active bladder (OAB) medication? 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2)."|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||participants|||Number
2720941|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4|"PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: Which of the following would typically describe your experience when you have a desire to urinate? 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change)."|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||participants|||Number
2720942|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4|"PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2)."|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||participants|||Number
2720952|NCT01091428|Secondary|Phase 2: Number of Participants With Clinically Significant Laboratory Values|Abnormal clinical laboratory values (serum chemistry, hematology and urinalysis) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|First dose to 30 days past last dose (Up to 27 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2720943|NCT01091519|Primary|Percentage of Participants Satisfied With Treatment at Month 4|"Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: overall, how satisfied are you with your OAB medication? and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including very satisfied and somewhat satisfied) and dissatisfied (including very dissatisfied, somewhat dissatisfied, and neither dissatisfied nor satisfied)."|Month 4|Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2720944|NCT01091454|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years||||months||95% Confidence Interval|Number
2720945|NCT01091454|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|up to 5 years||||months||95% Confidence Interval|Median
2720946|NCT01091454|Secondary|6-month Progression-free Survival (6-mo PFS) Rate|6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|At 6 months||||proportion of participants||95% Confidence Interval|Number
2720947|NCT01091454|Secondary|Duration of Response|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||months||95% Confidence Interval|Median
2720948|NCT01091454|Secondary|Confirmed Response Rate|A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Out of the total number of participants who completed the study and were evaluable for the primary endpoint and adverse events (as provided in the Participant Flow), only a subset of participants (Overall Number of Participants Analyzed specified above) were evaluable for the Confirmed Response Rate.|||percentage of confirmed responses||95% Confidence Interval|Number
2720949|NCT01091454|Primary|3-month Progression-free Survival (3-mo PFS) Rate|A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|3 months||||proportion of participants||95% Confidence Interval|Number
2720950|NCT01091428|Other Pre-specified|Banked Tumor Specimens for Candidate Markers of Response to Alisertib and Taxanes||Up to 24 Months|This Outcome Measure was originally registered as a Secondary but this Outcome Measure was Exploratory and no data was collected.||||||
2720951|NCT01091428|Secondary|Phase 2: Number of Participants With Clinically Significant Vital Sign Findings|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|First dose to 30 days past last dose (Up to 27 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2721363|NCT01087996|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||One month post-catheterization||||percentage of participants||95% Confidence Interval|Number
2720953|NCT01091428|Secondary|Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose to 30 days past last dose (Up to 27 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2720954|NCT01091428|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time form the date of the randomization to the date of death.|Up to data-cut off: 12 August 2014 (approximately 24 months)|mITT Population was defined as all participants who were randomized and received at least 1 dose of any study drug. For a participant that is alive, OS will be censored at the last known date.|||days||80% Confidence Interval|Median
2720955|NCT01091428|Secondary|Phase 2: Time to Disease Progression (TTP)|TTP was defined as the time from the date of randomization to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease or per CA-125 criteria with elevated (>70 units/mL) levels on 2 occasions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125.|Up to data-cut off: 12 August 2014 (approximately 24 months)|mITT Population was defined as all participants who were randomized and received at least 1 dose of any study drug. For a participant that has not progressed, TTP is censored at the last response assessment that is SD or better|||days||80% Confidence Interval|Median
2720956|NCT01091428|Secondary|Phase 2: Duration of Response (DOR)|DOR was defined as the time from the date of first documentation of a response to the date of first documentation of PD or the last response assessment that is stable disease (SD) or better for a participant who started alternate therapy without progression. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease or per CA-125 criteria with elevated (>70 units/mL) levels on 2 occasions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. A responder that did not experience disease progression is censored at the last response assessment that is SD.|Up to data-cut off: 12 August 2014 (approximately 24 months)|Participants from Response evaluable population, all participants who were randomized and had measurable disease according to RECIST 1.1 or assessable disease by CA-125 criteria, who received at least 1 dose of any study drug, and who had at least 1 available post-Baseline response assessment per RECIST 1.1 or CA-125 criteria, who were responders.|||days||80% Confidence Interval|Median
2720957|NCT01091428|Secondary|Phase 2: Combined Best Overall Response Rate (ORR)|Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).|At the end of Cycle 2 and at the completion of every 2 cycles until PD was documented or up to data cut-off: 12 August 2014 (approximately 24 months)|Response evaluable population was defined as all participants who were randomized and had measurable disease according to RECIST or assessable disease by CA-125 criteria, who received at least 1 dose of any study drug, and who had at least 1 available post-Baseline response assessment as per either RECIST or CA-125 criteria.|||percentage of participants||80% Confidence Interval|Number
2720958|NCT01091428|Secondary|Vz: Volume of Distribution During the Terminal Disposition Phase for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||liter||Standard Deviation|Mean
2720959|NCT01091428|Secondary|Vss: Volume of Distribution at Steady State for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||liter||Standard Deviation|Mean
2720960|NCT01091428|Secondary|CL: Total Clearance After Intravenous Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||liter per hour||Standard Deviation|Mean
2720961|NCT01091428|Secondary|t½: Terminal Half-Life for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||hour||Standard Deviation|Mean
2721203|NCT01089556|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint|TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).|||participants|||Number
2720962|NCT01091428|Secondary|AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||ng/mL*hr||Standard Deviation|Mean
2720963|NCT01091428|Secondary|AUClast: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||ng/mL*hr||Standard Deviation|Mean
2720964|NCT01091428|Secondary|Cmax: Maximum Observed Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||ng/mL||Standard Deviation|Mean
2720965|NCT01091428|Secondary|AUClast: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|PK analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng/mL*hr||Standard Deviation|Mean
2720966|NCT01091428|Secondary|AUC(Tau): Area Under the Concentration-Time Curve During a Dosing Interval for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|PK analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng/mL*hour(hr)||Standard Deviation|Mean
2720967|NCT01091428|Secondary|Tmax: Time to First Occurrence of Cmax for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|PK analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||hour||Full Range|Median
2720968|NCT01091428|Secondary|Cmax: Maximum Observed Concentration for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|Pharmacokinetic (PK) analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng/mL||Standard Deviation|Mean
2720969|NCT01091428|Secondary|Phase 1: Combined Best Overall Response Rate (ORR) in Participants With Recurrent Ovarian Cancer or Breast Cancer|Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).|At the end of Cycle 2 and at the completion of every 2 cycles until PD was documented or up to data cut-off: 12 August 2014 (approximately 24 months)|Response evaluable population was defined as all participants who were randomized and had measurable disease according to RECIST or assessable disease by CA-125 criteria, who received at least 1 dose of any study drug, and who had at least 1 available post-Baseline response assessment as per either RECIST or CA-125 criteria.|||percentage of participants||80% Confidence Interval|Number
2720970|NCT01091428|Primary|Phase 2: Progression-Free Survival (PFS)|PFS is defined as the time from the date randomization for Phase 2 participants to the date of first documented progressive disease (PD) or death as assessed by the investigator using both RECIST 1.1 criteria and CA-125 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease or CA-125 criteria with elevated (>70 units/mL) levels on 2 occasions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125.|At the end of Cycle 2 and at the completion of every 2 cycles until PD was documented or up to data cut-off: 12 August 2014 (approximately 24 months)|The modified intent-to-treat (mITT) population was defined as all participants who were randomized and received at least 1 dose of any study drug. For a participant that has not progressed and has not died or has started the alternate therapy, PFS is censored at the last response assessment that is stable disease (SD) or better.|||days||80% Confidence Interval|Median
2720971|NCT01091428|Primary|Phase 1: Number of Participants With Hypersensitivity and Neurotoxicity||Baseline up to Month 36|"Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.~Safety population was defined as all participants who received at least 1 dose of any study drug."|||participants|||Number
2720972|NCT01091428|Primary|Phase 1: Number of Participants With Clinically Significant Vital Sign Findings|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|First dose to 30 days past last dose (Up to 36 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2721550|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2720973|NCT01091428|Primary|Phase 1: Number of Participants With Clinically Significant Laboratory Values|Abnormal clinical laboratory values (serum chemistry, hematology and urinalysis) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|First dose to 30 days past last dose (Up to 36 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2720974|NCT01091428|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose to 30 days past last dose (Up to 36 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2720975|NCT01091428|Primary|Phase 1: MTD and RP2D for Paclitaxel in Combination With Alisertib|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of cycle 1).|Cycle 1 (Up to 28 days)|DLT-Evaluable Population was defined as all participants in the phase 1 who either experienced DLT during Cycle 1 or completed treatment with at least 15 of the planned 18 doses of alisertib and 2 of the planned 3 doses of paclitaxel in Cycle 1 and had sufficient follow-up data.|||mg/m^2|||Number
2720976|NCT01091428|Primary|Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel|The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities ≥Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.|Cycle 1 (Up to 28 days)|DLT-Evaluable Population was defined as all participants in the phase 1 who either experienced DLT during Cycle 1 or completed treatment with at least 15 of the planned 18 doses of alisertib and 2 of the planned 3 doses of paclitaxel in Cycle 1 and had sufficient follow-up data.|||mg|||Number
2720977|NCT01091363|Other Pre-specified|Biochemical Verification of Self-reported Abstinence|The salivary cotinine level was assessed by a NicAlert® test, using adopted a cutoff level 2 (30-100ng/ml).|12-month follow-ups|Korean Americans who had smoked at least 10 cigarettes a day for the past 6 months before study enrollment.|||Participants|||Count of Participants
2720978|NCT01091363|Secondary|Perceived Family Norm Toward Quitting Smoking|"Perceived family norm toward quitting smoking was assessed using the Perceived Family Norm Index consisting of two items assessing normative beliefs (i.e., I believe that my family [my friends] wants me to quit smoking) and motivation to comply with the belief (i.e., I am willing to comply with the belief). Score for each item can range from −3 strongly disagree to +3 strongly agree. The total score is the sum of the scores of the two items and can range from -6 to +6."|6-month follow-up|Korean Americans|||score on a scale||Full Range|Mean
2720979|NCT01091363|Primary|12-month Abstinence|The number of participants who had maintained smoking abstinence for the past 12 months|12 months|Korean Americans|||Participants|||Count of Participants
2720980|NCT01091259|Secondary|Number of Patients Who Experienced Grade 3 and Higher Toxicities||up to 3 years|Any patients who had at least one dose of treatment|||participants|||Number
2720981|NCT01091259|Secondary|Median Overall Survival|Defined as the length of time from the start of treatment that half of the patients are still alive.|up to 3 years|Intent-to-treat|||months||95% Confidence Interval|Median
2720982|NCT01091259|Secondary|Median Progression Free Survival|Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)|up to 3 years|Intent-to-treat|||months||95% Confidence Interval|Median
2720983|NCT01091259|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range).|up to 3 years|Intent-to-treat population|||percentage of patients||95% Confidence Interval|Number
2720984|NCT01091259|Primary|Progression Free Survival (PFS) Rate at 6 Months|The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.|6 months from the start of treatment|Intent-to-treat population.|||percentage of patients||95% Confidence Interval|Number
2720985|NCT01091246|Secondary|Percent of All Participants Reporting Any New Onset Chronic Disease (NOCD) From Administration of Investigational Product Through 180 Days Post Last Dose|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of participants|||Number
2720986|NCT01091246|Secondary|Percent of All Participants Reporting Any SAE From Administration of Investigational Product Through 180 Days Post Last Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of participants|||Number
2720987|NCT01091246|Secondary|Percent of Two-dose Participants Reporting Any SAE From Administration of Dose 2 During Days 0-28 Post Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summarized period (Q=1041; All FM=693).|||Percent of participants|||Number
2720988|NCT01091246|Secondary|Percent of All Participants Reporting Any Serious Adverse Event (SAE) From Administration of Investigational Product Through Day 28 Post Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of participants|||Number
2720989|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Dose 2 Through 28 Days Post Dose 2|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summariezed period (Q=1041; All FM=693).|||Percent of participants|||Number
2720990|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any safety data were recorded during the summarized period (Q=1083; All FM=719).|||Percent of Participants|||Number
2720991|NCT01091246|Secondary|Percent of All Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of Participants|||Number
2720992|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Dose 2 During Days 0-14 Post Dose 2|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1039; All FM=692).|||Percent of Participants|||Number
2720993|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1078; All FM=716).|||Percent of Participants|||Number
2721017|NCT01091246|Secondary|The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1320; All FM=878).|||percent of participants|||Number
2720994|NCT01091246|Secondary|Percent of All Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1377; All FM=920).|||Percent of Participants|||Number
2720995|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).|||Percent of Participants|||Number
2720996|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).|||Percent of participants|||Number
2720997|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=364; All FM=244).|||Percent of participants|||Number
2720998|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=460; All FM=321).|||Percent of participants|||Number
2720999|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).|||Percent of participants|||Number
2721000|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).|||Percent of participants|||Number
2721001|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).|||Percent of participants|||Number
2721002|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).|||Percent of participants|||Number
2721003|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FV=437).|||Percent of participants|||Number
2721004|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445).|||Percent of participants|||Number
2721005|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; All FM=883).|||Percent of participants|||Number
2721204|NCT01089556|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint|TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.|Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).|||participants|||Number
2721006|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).|||Percent of participants|||Number
2721007|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).|||Percent of participants|||Number
2721008|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=364; All FM=244).|||Percent of participants|||Number
2721009|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=460; All FM=321).|||Percent of participants|||Number
2721010|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).|||Percent of participants|||Number
2721011|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).|||Percent of participants|||Number
2721012|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).|||Percent of participants|||Number
2721013|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).|||Percent of participants|||Number
2721014|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FV=437).|||Percent of participants|||Number
2721015|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FY=441).|||Percent of participants|||Number
2721016|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; All FM=879).|||Percent of participants|||Number
2721018|NCT01091246|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. .|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464; FV=463; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445; FV=437; All FM=883).|||Geometric mean titer||Full Range|Geometric Mean
2721019|NCT01091168|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomisation to the first tumour progression or death due to any cause in the absence of previous documentation of objective tumour progression. PFS was performed in the ITT and eligible populations every 6 weeks based on RECIST version 1.1. For patients lost of follow up, or without a known record of progression or death, PFS was censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression which ever occured last.|From baseline to cut-off date(27 August 2012), up to 3 years|ITT population|||Months||95% Confidence Interval|Median
2721020|NCT01091168|Secondary|Disease Control Rate (DCR)|DCR was defined as the proportion of patients with Complete Response (CR), Partial Response (PR) and stable disease (SD), relative to the total number of patients in the analysed population.|From baseline up to 3 years 1 month|ITT population|||Percentage of participants||95% Confidence Interval|Number
2721021|NCT01091168|Primary|Overall Survival|The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.|From baseline up to 3 years 1 month|ITT population|||Months||95% Confidence Interval|Median
2721022|NCT01091155|Primary|Device Related Leak Rate up to 30 Days Post op|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|30 days post op||||participants|||Number
2721023|NCT01091155|Secondary|Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.|"The post operative parameters that will be measured during hospitalization period:~Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home~First day to first postoperative flatus~First day to first postoperative bowel movements~First day of first postoperative toleration of liquids and solids (time to keeping them down)"|30 days post op|||||||
2721024|NCT01091155|Primary|To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|Approx. 1 year|||||||
2721025|NCT01091116|Secondary|Clinically Significant Abnormal Laboratory Tests|"Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators.~The following hematochemical and urinary parameters were analysed:~Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin."|up to 4 months from screening|Percentage of patients with clinically significant abnormal laboratory tests|||participants|||Number
2721026|NCT01091116|Secondary|Adverse Event Reports|Incidence of spontaneously reported adverse events|up to 4 months after screening|The number of patients reflects all patients administered at least one dose of the investigational product.|||participants|||Number
2721027|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]|"Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Over Weight patients (BMI >25)|||mm||Standard Deviation|Mean
2721028|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]|"Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Normal Weight patients (BMI <=25)|||mm||Standard Deviation|Mean
2721029|NCT01091116|Secondary|Patient Global Assessment|"Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm).~Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0).~A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms."|up to 3 months after first dose|intention to treat (ITT) population|||mm||Standard Deviation|Mean
2721030|NCT01091116|Secondary|Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria|"Osteoarthritis Research Society International (OARSI).~Response defined as:~a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale~OR if two of the following three findings are recorded:~a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient's global assessment by 20% or more and by 10 or more points on the scale."|up to 3 months after first dose|intention to treat (ITT) population|||percentage of patients|||Number
2721094|NCT01090453|Secondary|Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.|The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721031|NCT01091116|Secondary|WOMAC VA 3.1. C Score (Function)|"Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours.~The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).~A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities.~WOMAC VA 3.1.C scores at baseline and at Week 13 are reported."|up to 3 months after first dose|Intention to Treat (ITT) population|||mm||Standard Deviation|Mean
2721032|NCT01091116|Secondary|WOMAC VA 3.1.B Score (Knee Stiffness)|"WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).~A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness.~The change at Week 13 from baseline is reported."|up to 3 months after first dose|Intention to Treat (ITT) population|||mm||Standard Deviation|Mean
2721033|NCT01091116|Primary|WOMAC VA 3.1 A Score (Total Pain)|"Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours.~The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain).~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.~The change from baseline was assessed along 3 weeks after first drug administrations."|over the 3 weeks after the first administration|analysis of the intention to treat (ITT) population|||mm||Standard Deviation|Mean
2721034|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.|Baseline, Week 65|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 65.|||mmol/mmol creatinine||Standard Deviation|Mean
2721035|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.|Baseline, Week 57|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 57.|||mmol/mmol creatinine||Standard Deviation|Mean
2721036|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.|Baseline, Week 49|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 49.|||mmol/mmol creatinine||Standard Deviation|Mean
2721037|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.|Baseline, Week 41|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 41.|||mmol/mmol creatinine||Standard Deviation|Mean
2721038|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide||Baseline, Week 33|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 33.|||mmol/mmol creatinine||Standard Deviation|Mean
2721039|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.|Baseline, Week 25|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 25.|||mmol/mmol creatinine||Standard Deviation|Mean
2721040|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.|Baseline, Week 17|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 17.|||mmol/mmol creatinine||Standard Deviation|Mean
2721041|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.|Baseline, Week 9|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 9.|||mmol/mmol creatinine||Standard Deviation|Mean
2721042|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.|Baseline, Week 5|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 5.|||mmol/mmol creatinine||Standard Deviation|Mean
2721043|NCT01091103|Secondary|Median Time to Study Drug Discontinuation|Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.|Duration of study treatment through the data cutoff, up to 3 years.|All participants who received any amount of enzalutamide. Fifteen (25.0%) participants were still on study drug as of the data cutoff date and were censored at the data cutoff date.|||months||95% Confidence Interval|Median
2721044|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.~Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.~The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
2721045|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.~Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.~The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
2721046|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.~Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
2721047|NCT01091103|Secondary|Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)|Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.|Baseline, Week 9|Participants who received any amount of enzalutamide and had PSA values at baseline and at the Week 9 Visit.|||percentage of participants||95% Confidence Interval|Number
2721048|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.~Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
2721049|NCT01090973|Secondary|Number of Participants With Adverse Events (AEs)|"Investigators intended to evaluate the safety and tolerability profile of LBH589. Assessments would consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, vital signs, ECOG performance status, and the regular physical examinations and ECG assessments.~Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. CTCAE v3.0 can be accessed on the National Institute of Health (NIH)/NCI website at http://ctep.cancer.gov/forms/CTCAEv3.pdf."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||participants|||Number
2721050|NCT01090973|Secondary|Number of Participants With Improved Blood and Lymphatic Evaluation Results|Investigators intended to evaluate histone acetylation, cytotoxic mixed lymphocyte reaction (MLR) activity, cytokine profiles, and immunologic synapse alterations through peripheral blood correlative studies|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
2721051|NCT01090973|Secondary|Number of Participants With Prolonged Corrected QT (QTc) Interval|Investigators intended to monitor the QTc interval in patients receiving oral LBH589|8 weeks (2 cycles) unless treatment continues due to partial or complete response|||||||
2721052|NCT01090973|Secondary|Progression Free Survival (PFS) Estimate|Investigators intended to estimate the progression free survival time|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
2721053|NCT01090973|Secondary|Response Duration|Investigators intended to determine the duration of responses.|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
2721054|NCT01090973|Secondary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Investigators intended to determine the complete and partial responses. Chronic Lymphocytic Leukemia (CLL): Using the NCI criteria - - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.~Mantle Cell Lymphoma (MCL): Based on the International Workshop to Standardize Response Criteria to NHL (Cheson, JCO 1999) - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
2721095|NCT01090453|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2721055|NCT01090973|Primary|Number of Participants With Desired Response|"Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).~WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed <50% of normal daytime; 3 Needs to be in bed >50% of normal daytime; 4 Unable to get out of bed."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
2721056|NCT01090765|Secondary|Clinical Response|Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% decrease in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|56 days (one cycle = 28 days, restaging post cycle 2)||||Participants|||Count of Participants
2721057|NCT01090765|Secondary|Prostatic-Specific Antigen (PSA) Decline|PSA decline (i.e., PSA greater than 4.0 ng/mL) is defined as two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting values for PSA). Normal PSA is 4.0 ng/mL or lower.|1- week intervals up to 6 months||||Participants|||Count of Participants
2721058|NCT01090765|Secondary|Dose Limiting Toxicity (DLT)|Dose limiting toxicity is defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possibly related to TRC105.|First 28 days on study||||Participants|||Count of Participants
2721059|NCT01090765|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 43 months, 5 days||||Participants|||Count of Participants
2721060|NCT01090765|Primary|Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.|The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.|6 months||||mg/kg every 2 weeks|||Number
2721061|NCT01090752|Secondary|Effects of Pioglitazone on Salt Sensitivity||2009||2010-06-30|06/2010||||
2721062|NCT01090752|Primary|Effects of Pioglitazone on 24h Blood Pressure Control|24 hour blood pressure measurements were performed after each treatment/diet phase|march 2009||||mmHg||Standard Error|Mean
2721063|NCT01090752|Primary|Effects of Pioglitazone on Sodium and Lithium Clearances|At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances|2007||||ml/min||Standard Error|Mean
2721064|NCT01090752|Primary|Effects of Pioglitazone on Renal Hemodynamics|At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF|2008||||ml/min/1.73m2||Standard Error|Mean
2721065|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Physician Visits Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects|||physician visits||Standard Deviation|Mean
2721066|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects|||days||Standard Deviation|Mean
2721067|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Pads Per Day Subject Took for FI|Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI|36 Month Follow-up Visit|All implanted subjects|||pads per day||Standard Deviation|Mean
2721068|NCT01090739|Other Pre-specified|Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)|The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better|36 Month Follow-up Visit|All implanted subjects|||units on a scale||Standard Deviation|Mean
2721069|NCT01090739|Secondary|Change in Numeric Pelvic Pain Scale (NPPS)|Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.|12 Month Follow-up Visit|All subjects implanted at the time the NPPS was implemented in the study|||units on a scale||Standard Deviation|Mean
2721070|NCT01090739|Secondary|Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)|Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
2721106|NCT01090453|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||titers||95% Confidence Interval|Geometric Mean
2721071|NCT01090739|Secondary|Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores|"Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).~The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score."|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
2721072|NCT01090739|Secondary|Change in Pelvic Floor Distress Inventory (PFDI-20) Scores|"Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).~The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale."|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
2721073|NCT01090739|Secondary|Change in Fecal Incontinence Quality of Life Score|Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
2721074|NCT01090739|Secondary|Change in Wexner Symptom Severity Score|Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
2721075|NCT01090739|Secondary|Change in Urge Fecal Incontinence Episodes|Number of urge fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted|||urge fecal incontinent episodes/14 days||Full Range|Median
2721076|NCT01090739|Secondary|Change in Fecal Incontinence Days|Number of fecal incontinence days in a 14 day period|36 Month Follow-up Visit|All subjects implanted|||fecal incontinent days/14 days||Full Range|Median
2721077|NCT01090739|Secondary|Change in Fecal Incontinence Episodes|Number of fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted|||fecal incontinent episodes/14 days||Full Range|Median
2721078|NCT01090739|Primary|Percentage of Responders|The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.|12 Months|All subjects implanted|||percentage of treatment responders||95% Confidence Interval|Number
2721079|NCT01090492|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.|Screening up to 28 days after last study dose (up to 98 days)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||participants|||Number
2721080|NCT01090492|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements|Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.|Screening up to 28 days after last study dose (up to 98 days)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||participants|||Number
2721081|NCT01090492|Secondary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leukocytes (<0.6 LLN /greater than [>] 1.5*upper LN [ULN]; platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8* LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (>3*ULN); BUN, creatinine (>1.3*ULN); glucose (<0.6 LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN/>1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN/>1.1*ULN); albumin, total protein (<0.8*LLN/>1.2*ULN); creatine kinase (>2.0*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.|Screening up to 28 days after last study dose (up to 98 days)|Analysis population included all randomized participants who took at least 1 dose of study medication along with at least 1 on-treatment laboratory test result.|||participants|||Number
2721082|NCT01090492|Secondary|Plasma Concentration of PF-00489791 and Its Metabolites|Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.|Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)|Analysis population included participants who received 1 dose of study drug and were analyzed for pharmacokinetic parameters. Here, Overall number of participants signifies participants evaluable for either first or second intervention period and number analyzed signifies those participants who were evaluable at specified time points.|||mcg/mL||Standard Deviation|Mean
2721162|NCT01090011|Secondary|CL/F,ss,15|Apparent clearance of afatinib in plasma at steady state after extravascular multiple dose administration (CL/F,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2721083|NCT01090492|Secondary|Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort|Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.|Baseline, Day 14, 28|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||participants|||Number
2721084|NCT01090492|Secondary|Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4|Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.|Baseline, Week 1, 2, 3, 4|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2721085|NCT01090492|Secondary|Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4|Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.|Baseline, Week 4|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||minutes per attack||Standard Deviation|Mean
2721086|NCT01090492|Secondary|Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4|Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.|Baseline, Week 1, Week 2, Week 3, Week 4|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||Raynaud's attacks||Standard Deviation|Mean
2721087|NCT01090492|Primary|Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4|The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.|Baseline, Week 4|Per-protocol analysis set (PPAS) included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion.|||units on a scale||Standard Deviation|Mean
2721088|NCT01090479|Secondary|Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery||7 days|||||||
2721089|NCT01090479|Primary|Number of Patients With a Clinically Diagnosed Infection||2 months post-operatively||||participants|||Number
2721090|NCT01090453|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2721091|NCT01090453|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2721092|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.|||Participants|||Count of Participants
2721093|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.|||Participants|||Count of Participants
2721096|NCT01090453|Secondary|Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.|The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721097|NCT01090453|Secondary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721098|NCT01090453|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2721099|NCT01090453|Secondary|Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.|The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721100|NCT01090453|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||titers||95% Confidence Interval|Geometric Mean
2721101|NCT01090453|Secondary|Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.|The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721102|NCT01090453|Secondary|Concentrations for Anti-HBs.|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||mIU/mL||95% Confidence Interval|Geometric Mean
2721103|NCT01090453|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721104|NCT01090453|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||IU/mL||95% Confidence Interval|Geometric Mean
2721105|NCT01090453|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.|The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721163|NCT01090011|Secondary|MRTpo,ss|mean residence time of Afatinib in the body at steady state after oral administration (MRTpo,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||h||Geometric Coefficient of Variation|Geometric Mean
2721107|NCT01090453|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2721108|NCT01090453|Secondary|Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs|The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721109|NCT01090453|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs|The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721110|NCT01090453|Primary|Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off|The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721111|NCT01090453|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off|The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
2721112|NCT01090427|Secondary|The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1||Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.|||Percentage of participants|||Number
2721113|NCT01090427|Secondary|The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12|The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.|||Scores on a scale||Standard Deviation|Mean
2721114|NCT01090427|Secondary|The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.|||Percentage of participants|||Number
2721115|NCT01090427|Secondary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12|The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.|||Percentage of participants|||Number
2721116|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.|Week 12|The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.|||Percentage of Participants|||Number
2721117|NCT01090427|Secondary|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.|Baseline; Week 12|Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.|||Scores on a scale||Standard Deviation|Mean
2721118|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.|Week 12|The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.|||Percentage of Participants|||Number
2721119|NCT01090427|Primary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.|Week 12|The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.|||Percentage of Participants|||Number
2721120|NCT01090414|Secondary|Time to Response|Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response.|Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)|Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.|||Months||Inter-Quartile Range|Median
2721121|NCT01090414|Secondary|Overall Survival|Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates.|Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)|Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.|||Months||95% Confidence Interval|Median
2721122|NCT01090414|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates.|Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)|Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.|||Months||95% Confidence Interval|Median
2721123|NCT01090414|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.|Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)|Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.|||Months||95% Confidence Interval|Median
2721124|NCT01090414|Primary|Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events||Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days|Data presented includes data from both the parent studies and this Study 101-99. For this safety endpoint, data was prespecified to be combined.|||percentage of participants|||Number
2721125|NCT01090414|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).|Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)|Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.|||percentage of participants||95% Confidence Interval|Number
2721126|NCT01090323|Secondary|Change in Serum Ferritin From Start of ICL670 to End of Study|The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.|0 - 60 months|The primary analysis was on Full Analysis Set which comprised all participants who received at least one dose of ICL670 during the core or the extension phase of the study. All participants previously treated with ICL670 or DFO for 52 weeks in the core study were eligible for enrollment.|||µg/L||Full Range|Median
2721127|NCT01090323|Primary|Number of Participants With Adverse Events After Start of ICL670|Safety as assessed by the number of participants with adverse event or death after the start of ICL670.|0 - 60 months|The primary analysis was on Safety Analysis Set which comprised all participants who received at least one dose of ICL670 during the core/extension phase of the study. All participants previously treated with ICL670/DFO for 52weeks in the core study.|||participants|||Number
2721164|NCT01090011|Secondary|t1/2,ss|Terminal half-life of Afatinib in plasma at steady state (t1/2,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||h||Geometric Coefficient of Variation|Geometric Mean
2721128|NCT01090310|Secondary|Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension|IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Units on a scale||Standard Deviation|Mean
2721129|NCT01090310|Secondary|Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies|Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Number of participants|||Number
2721130|NCT01090310|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Letters||Standard Deviation|Mean
2721131|NCT01090310|Secondary|Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Number of participants|||Number
2721132|NCT01090310|Primary|The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Days||95% Confidence Interval|Median
2721133|NCT01090180|Secondary|Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe|The QIDS-SR is a 16-item measure of depression symptom severity with a range from 0-27. Each item is rated from 0-3 with higher scores are indicative of higher symptom severity. Scores of the items are aggregated (with the highest score on overlapping items chosen; e.g., sleep disturbances, changes in eating) to generate the total score..|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.||||units on a scale||Standard Deviation|Mean
2721134|NCT01090180|Primary|PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period|The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.|Male veterans with combat-related PTSD|||units on a scale||Standard Deviation|Mean
2721135|NCT01090102|Secondary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover|Log(10) change in the percentage of activated T cells during the second 12 weeks of the study|Week 12, Week 24||||Log10(percentage of T cells)||95% Confidence Interval|Mean
2721136|NCT01090102|Primary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study||Week 0, Week 12|1 participant assigned to first receive Mesalamine was excluded from analysis due to having withdrawn participation without receiving the allocated intervention|||Log10(percentage of T cells)||95% Confidence Interval|Mean
2721137|NCT01090076|Primary|% Wound Area Week 2|Percentage change in wound area after week 2|Weeks 1 to 2||||Percentage change||Standard Error|Mean
2721138|NCT01090076|Primary|% Wound Area Week 1|Percentage change in wound area after week 1|week 0 to 1||||percent change||Standard Error|Mean
2721165|NCT01090011|Secondary|Peak-trough Fluctuation (PTF)|Peak-trough fluctuation (PTF) of plasma afatinib for the combination arm. PTF = 100*(Cmax-Cmin)/Caverage where Caverage = AUC/time, where time equals 24 hours.|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||% of average concentration||Geometric Coefficient of Variation|Geometric Mean
2721139|NCT01090076|Primary|% Viable Tissue|"-Percentage viable tissue after 2 weeks~The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue."|weeks 1 to 2||||Percentage of viable tissue||Standard Error|Mean
2721140|NCT01090063|Secondary|Safety Outcome Measures|All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.|24 weeks|All participants who enrolled. Participants terminating prior to week 24 had their data carried forward as lost to follow-up.|||participants|||Number
2721141|NCT01090063|Secondary|Pain Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how much pain are you experiencing from your disease of your hands and feet, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||units on a scale||Standard Deviation|Mean
2721142|NCT01090063|Secondary|Pruritus Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how itchy are you, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||units on a scale||Standard Deviation|Mean
2721143|NCT01090063|Secondary|Fissure Count (if Present at Baseline) From Baseline to Week 24|Number of discrete fissures on the hands and feet of each subject.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||fissures||Standard Deviation|Mean
2721144|NCT01090063|Secondary|Pustule Count (if Present at Baseline) From Baseline to Week 24|Number of pustules present in each subject|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||pustules||Standard Deviation|Mean
2721145|NCT01090063|Secondary|PGA Score Over Time From Baseline to Week 24|Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||units on a scale||Full Range|Median
2721146|NCT01090063|Primary|Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.||16 weeks|Number of participants completing enrollment. Lost values carried forward as last observation carried forward|||percentage of participants|||Number
2721147|NCT01090050|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.|Day 121||||Units on a scale||Standard Deviation|Mean
2721148|NCT01090050|Secondary|Migraine Disability Assessment(MIDAS)Questionnaire Total Score|"Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study at Day 121.||||scores on a scale||Standard Deviation|Mean
2721149|NCT01090050|Secondary|Percent Change of Doses of Study Medication|"Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.||||percent doses of study medication||Standard Deviation|Mean
2721150|NCT01090050|Secondary|Migraine Headache Days With Greater Than 50% Reduction|Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.||||participants|||Number
2721151|NCT01090050|Secondary|Migraine Headache Duration From Time of Treatment to Pain Free|"Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.||||percent hours of migraine duration||Standard Deviation|Mean
2721166|NCT01090011|Secondary|Concentration of Afatinib in Plasma for the Combination Arm|Minimum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmin,ss). Maximum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmax,ss).|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721152|NCT01090050|Secondary|Migraine Headache Duration From Onset to Pain Free|"Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.||||percent hours of migraine duration||Standard Deviation|Mean
2721153|NCT01090050|Secondary|Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline|"Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation.~e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)"|Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.||||percent migraine headache days per month||Standard Deviation|Mean
2721154|NCT01090050|Primary|Percent Change of Migraine Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)|Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.||||percent migraine headache days per month||Standard Deviation|Mean
2721155|NCT01090011|Secondary|Progression-Free Survival (PFS) Time|Progression-Free Survival was defined as the duration of time from start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to RECIST 1.1) or death.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||months||95% Confidence Interval|Median
2721156|NCT01090011|Secondary|Duration of Disease Control (According to RECIST v1.1)|Duration of disease control was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence SD, PR or CR.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||months||Standard Deviation|Mean
2721157|NCT01090011|Secondary|Duration of Objective Response (According to RECIST v1.1)|Duration of objective response was measured from the time measurements criteria were met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since treatment started).|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||months||Standard Deviation|Mean
2721158|NCT01090011|Secondary|Objective Tumor Response (Complete Response [CR] and Partial Response [PR]) Determined by RECIST v1.1)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Objective tumor response = CR + PR."|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721159|NCT01090011|Secondary|Disease Control (CR, PR and Stable Disease (SD) Determined by RECIST v1.1)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Disease control = CR + PR + SD.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients||95% Confidence Interval|Number
2721160|NCT01090011|Secondary|Predose Plasma Concentrations of Afatinib for the Combination Arm|Predose plasma concentrations (Cpre,ss) of Afatinib at Course 1, Visit 2, 3, 4 and 5, at Course 2, Visit 1 and 2 and at Course 3, Visit 1.|Up to 57 days|Pharmacokinetic dataset (PKS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721161|NCT01090011|Secondary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||L||Geometric Coefficient of Variation|Geometric Mean
2721167|NCT01090011|Secondary|Area Under the Concentration-time Curve (AUC) on Day 15 of Plasma Afatinib for the Combination Arm|Area Under the Concentration-time Curve (AUC) of Afatinib in plasma at steady state over a uniform dosing interval tau (15 days) (AUCtau,ss) after oral administration of Afatinib and cetuximab combination therapy|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2721168|NCT01090011|Secondary|Frequency (%) of Patients With Related Serious Adverse Events|Frequency (%) of patients with drug-related serious adverse events|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721169|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Death||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721170|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Treatment Discontinuation|Frequency (%) of patients with adverse events leading to treatment discontinuation|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721171|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Dose Reduction||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721172|NCT01090011|Secondary|Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721173|NCT01090011|Secondary|Highest CTCAE Grade|Safety of afatinib when administered together with cetuximab as indicated by intensity and incidence of adverse events, graded according to the U.S. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version (v) 3.0|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
2721174|NCT01090011|Primary|The Primary Endpoint is the Occurrence of Dose Limiting Toxicity (DLT).|"A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria:~CTCAE Grade 2 or higher decrease in cardiac left ventricular function~CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy~CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days~CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days~CTCAE Grade ≥3 rash despite standard medical management~CTCAE Grade ≥3 fatigue lasting for more than 7 days~CTCAE Grade 4 hypomagnesaemia or Grade 3 hypomagnesaemia with clinical significant sequelae~All other toxicities of CTCAE Grade ≥3 (except alopecia, and allergic reaction) leading to an interruption of afatinib and/or cetuximab for more than 14 days until recovery to baseline or Grade 1, whichever was higher."|from day 1 treatment until progression or undue toxicity, up to 28 days|Treated set for Cohort One. Cohort one was based on the data from the first treatment cycle where four patients received 'Afatinib 40+Cetuximab 250' and six patients received 'Afatinib 40+Cetuximab 500'.|||participants|||Number
2721175|NCT01089751|Secondary|Change From Baseline in Urgency Urinary Incontinence (UUI)|"Urgency urinary incontinence is identified if the patient marks Yes for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement."|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||UUI episodes||Standard Deviation|Mean
2721176|NCT01089751|Secondary|Change From Baseline in Urgency Severity|The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Score on a scale||Standard Deviation|Mean
2721177|NCT01089751|Secondary|Change From Baseline in Voided Volume|Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||cubic centimeters (cc)||Standard Deviation|Mean
2721178|NCT01089751|Secondary|Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)|The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Score on a scale||Standard Deviation|Mean
2721179|NCT01089751|Secondary|Change From Baseline in Urgency-Related Toilet Voids|"Urgency-related toilet void (or urinary urgency) is identified if the patient marks Yes for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement."|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Toilet void||Standard Deviation|Mean
2721180|NCT01089751|Secondary|Change From Baseline in Nocturic Toilet Voids|"A nocturic (nighttime) toilet void is identified if the patient marks Yes for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement."|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Nocturic toilet void||Standard Deviation|Mean
2721181|NCT01089751|Secondary|Change From Baseline in Continent Days Per Week (CDW)|Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Continent days per week||Standard Deviation|Mean
2721182|NCT01089751|Primary|Percentage of Patients Continent (PPC)|PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.|Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Percentage of participants|||Number
2721183|NCT01089647|Primary|Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep|by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range|3 months||||Participants|||Count of Participants
2721184|NCT01089608|Primary|Visual Analogue Scale (VAS - Ranges 0-100 mm)|The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)|Baseline and D63 (D63 minus baseline)|Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.|||units on a scale (from 0 to 100 mm)||95% Confidence Interval|Least Squares Mean
2721185|NCT01089595|Secondary|Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging||Every 8 weeks for up to 5 years|Too few participants to provide meaningful analysis|||Participants|||Count of Participants
2721186|NCT01089595|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. It will be determined for both RECIST (Response Evaluation Criteria in Solid Tumors) and CHOI criteria.|6 months until death or for 5 years||||weeks||Standard Deviation|Mean
2721187|NCT01089582|Secondary|Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12|The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.|Baseline to Week 12.|FAS.|||participants|||Number
2721188|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT||Week 12.|FAS.|||participants|||Number
2721693|NCT01085045|Secondary|Peak Change From BL IC on Day 7|Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2721190|NCT01089582|Primary|Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.|||scores on a scale||Standard Deviation|Mean
2721191|NCT01089582|Primary|Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.|||scores on a scale||Standard Deviation|Mean
2721192|NCT01089582|Primary|Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12|The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'.|Baseline, Week 12.|FAS.|||participants|||Number
2721193|NCT01089582|Primary|Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12|CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.|Baseline, Week 12.|Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.|||participants|||Number
2721194|NCT01089569|Secondary|Change From Baseline in Weight Changes|"Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.~Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.~Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks)."|baseline - final visit (32 weeks)||||lbs (pounds)||Standard Deviation|Mean
2721195|NCT01089569|Secondary|Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks).~AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day"|baseline - final visit (32 weeks)||||mg/dL*24hr||Standard Deviation|Mean
2721196|NCT01089569|Secondary|Change From Baseline in CGM Glucose Variability|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range)~IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks)."|baseline to final visit (32 weeks)||||mg/dL||Standard Deviation|Mean
2721197|NCT01089569|Secondary|Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve)~Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (|p subscript 50 zero - p subscript 50 23|+Sum superscript 23 subscript i = 1| p subscript 50i - p subscript 50 i-1| over T.~i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles"|baseline to final visit (32 weeks)||||mg/dL/hr||Standard Deviation|Mean
2721198|NCT01089569|Secondary|Change From Baseline in Incidence of Hypoglycemia (Degree)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)"|baseline to final visit (32 weeks)||||percentage of measures under 70 mg/dL||Standard Deviation|Mean
2721199|NCT01089569|Secondary|Change From Baseline in Incidence of Hypoglycemia (Frequency)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency)~Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)"|baseline to final visit (32 weeks)||||episodes/day||Standard Deviation|Mean
2721200|NCT01089569|Primary|HbA1c Change|"Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination.~Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin."|baseline to final visit (32 weeks)||||%HbA1c||Standard Deviation|Mean
2721201|NCT01089556|Secondary|Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint||Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).|||participants|||Number
2721205|NCT01089556|Secondary|Mean Change in Heart Rate From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one heart rate measurement during Weeks 9- 16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
2721206|NCT01089556|Other Pre-specified|Mean Change in Heart Rate From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline heart rate measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
2721207|NCT01089556|Secondary|Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BP measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
2721208|NCT01089556|Other Pre-specified|Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BP measurement during Week 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
2721209|NCT01089556|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and at least one PGI-I measurement during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721210|NCT01089556|Other Pre-specified|Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and at least one post-baseline PGI-I measurement during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721211|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 9-16 (Study Period III).|||hours||Standard Deviation|Mean
2721212|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Baseline Through Week 8|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 1-8 (Study Period II).|||hours||Standard Deviation|Mean
2721213|NCT01089556|Secondary|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 9-16 (Study Period III).|||days||Standard Deviation|Mean
2721214|NCT01089556|Other Pre-specified|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 1-8 (Study Period II).|||days||Standard Deviation|Mean
2721215|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one HADS measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721216|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline HADS measurements during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721217|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one SDS measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721218|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline SDS measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721219|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one NPSI measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721220|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline NPSI measurements during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721221|NCT01089556|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and had at least one CGI-I measurement during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721222|NCT01089556|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I) at Week 8 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and had at least one post-baseline CGI-I measurement during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721223|NCT01089556|Secondary|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
2721224|NCT01089556|Other Pre-specified|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
2721235|NCT01089517|Secondary|The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit|The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit|24 weeks|Intent to Treat Population (last observation carried forward)|||% subjects (i.e gaining >/=15 letters)|||Number
2721236|NCT01089517|Primary|Mean Change in Visual Acuity From Baseline at the Week 24 Visit|The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit|24 Weeks|Intent to Treat Population (last observation carried forward)|||ETDRS Letters||Standard Error|Mean
2721225|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
2721226|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
2721227|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
2721228|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
2721229|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score|BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721230|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II).|||units on a scale||90% Confidence Interval|Least Squares Mean
2721231|NCT01089556|Primary|Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
2721232|NCT01089543|Secondary|Rate of Satisfactory Symptom Relief|"The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants."|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol.|||Percentage of participants|||Number
2721233|NCT01089543|Primary|Rate of Complete Dyspepsia Symptom Relief|The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) population defined as those participants who complied with the study protocol.|||Percentage of Participants|||Number
2721234|NCT01089517|Secondary|Proportion of Patients With at Least 1 Adverse Event||24 weeks|Safety Analysis Population|||% of patients with adverse events|||Number
2721249|NCT01089361|Secondary|Adverse Effects Attributable to Ketamine||7 days||||adverse events|||Number
2721250|NCT01089361|Primary|Serum Levels of IL-6, IL-10 and TNFα||first 7 days of admission, Baseline and Day 7 reported||||pg/mL||Inter-Quartile Range|Median
2721237|NCT01089504|Secondary|Number of Participants With One or More Seizures|Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.|||participants|||Number
2721238|NCT01089504|Secondary|Mean Bayley Scales of Infant Development (BSID) Score - Motor|This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2721239|NCT01089504|Primary|Mean Bayley Scales of Infant Development (BSID) Score - Cognitive|The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) - very similar to the more familiar IQ score.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2721240|NCT01089413|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.|Baseline up to Cycle 51 (1 cycle = 21 days)|FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles.|||percentage of participants|||Number
2721241|NCT01089413|Secondary|Percentage of Participants With Best Overall Response|Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (<70 years, 70-80 years, and >80 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS. Here, number of participants analyzed = participants with available data for this outcome.|||percentage of participants|||Number
2721242|NCT01089413|Secondary|Progression-Free Survival (PFS)|PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and ≥70 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS.|||months||95% Confidence Interval|Median
2721243|NCT01089413|Primary|Duration of Bevacizumab Treatment|Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus [+] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and greater than or equal to [≥] 70 years) as well as for overall participants.|Baseline up to end of treatment (up to approximately 3 years)|FAS.|||months||95% Confidence Interval|Median
2721244|NCT01089361|Other Pre-specified|PCR Substudy|PCR analysis on serum samples for presence of bacterial and mitochondrial DNA; This substudy was not done.|Daily up to 7 days|Not done||||||
2721245|NCT01089361|Secondary|28 Day Mortality||28 days||||deaths|||Number
2721246|NCT01089361|Secondary|Length of Intensive Care Unit (ICU) Stay||28 days||||days||Standard Deviation|Mean
2721247|NCT01089361|Secondary|Acute Physiology and Chronic Health Evaluation (APACHE) Scores|Difference in average APACHE-II score between the intervention and placebo groups. APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity of disease classification system for patients admitted to the Intensive Care Unit. It uses an integer score from 0 to 71 that is computed based on age, 12 routine physiological measurements (i.e. heart rate, temperature, laboratory values), and previous health status obtained during the first 24 hours after ICU admission. Higher scores correspond to more severe disease and a higher risk of death.|First 24 hours after ICU admission||||APACHE score||Standard Deviation|Mean
2721248|NCT01089361|Secondary|Organ Failures|Incidence of new organ failure as detected by Sequential Organ Failure Assessment [SOFA] score. Definitions are as follows. Central nervous system: delirium, coma, uncontrollable seizures, ICP>20cm H2O Cardiac: MAP <60mmHg, blood pressure supported with pressors, 50 > HR > 120 Respiratory: vented, RR>30, PaO2<60, PaCO2 > 55, Sat<92% Kidney: RIFLE criteria Anemia: Hct<27, transfusion of PRBC Thrombocytopenia: platelet < 50k, platelet transfusion Liver: biopsy, ALT>200, AST>200, t.bil>2.0, ALP>300 Coagulation failure: INR>2 if no anticoagulation therapy|7 days||||participants with increase in SOFA score|||Number
2721252|NCT01089231|Secondary|Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)|Fasting venous blood samples were collected and RBC membrane FA composition including the omega-3 index, given as EPA + DHA, was analyzed at baseline and after 12 weeks according to the omega-3 index methodology (Harris & von Schacky, 2004). Results are presented as a percentage of the total identified FAs after response factor correction. The coefficient of variation for EPA + DHA was 5%. Quality was assured according to DIN ISO 15189.|baseline and after 12 weeks||||percentage of total fatty acids||Standard Deviation|Mean
2721253|NCT01089231|Primary|Gene Expression Changes|Gene expression changes were measured by using whole genome microarrays. The expression values of all genes were compared between baseline and 4 hours, 7 days and twelve weeks after supplementation with FO or CO and differentially expressed genes were detected by standard two-state pooled-variance t-test (p<0,05). The number of differentially expressed genes (regulated genes)compared to the baseline values were determined for every study group in total as well as for every time point (4 hours, 7 days, 12 weeks)in total and specifically.|Gene expression changes (number of regulated genes)||||number of regulated genes|||Number
2721254|NCT01089127|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2721255|NCT01089127|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2721256|NCT01089062|Secondary|Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose|The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose|Patients with available data at the required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
2721257|NCT01089062|Secondary|Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods|Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.|baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose|Patients with available data at the required time point were included in the analysis population.|||mmHg||Standard Deviation|Mean
2721258|NCT01089062|Secondary|AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose|AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|4 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.|||mmHg*min||Standard Deviation|Mean
2721259|NCT01089062|Secondary|Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.|||mmHg||Standard Deviation|Mean
2721260|NCT01089062|Secondary|Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.|||percentage of participants|||Number
2721261|NCT01089062|Primary|AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose|AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|2 hours from time of first dose|Patients with available data at the required time point were included in the analysis population.|||mmHg*min||Standard Deviation|Mean
2721262|NCT01089023|Secondary|Erythrocyte Sedimentation Rate|ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||mm/hr||Standard Deviation|Mean
2721263|NCT01089023|Secondary|C-Reactive Protein (CRP) Values by Study Visit|CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||mg/L||Standard Deviation|Mean
2721264|NCT01089023|Secondary|HAQ-DI Score by Visit|HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3..|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||scores on a scale||Standard Deviation|Mean
2721265|NCT01089023|Secondary|Percentage of Participants With Improvement in Physical Function by HAQ-DI Category|Physical function scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
2721266|NCT01089023|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units|HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
2721267|NCT01089023|Secondary|Time to DAS28 Response by DAS28 Category|Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline).|Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||days||Standard Error|Mean
2721268|NCT01089023|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
2721269|NCT01089023|Secondary|Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
2721270|NCT01089023|Primary|Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events|Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.|Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||percentage of participants|||Number
2721271|NCT01088997|Secondary|Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|An echocardiogram obtained while on milrinone was obtained with the goal of attempting to look for improvements in parameters associated with pulmonary hypertension. The primary parameter measured was the myocardial performance index (MPI). An Echocardiogram was performed at baseline (pre-infusion) and repeated 12-24 hours ater the initiation of the Milrinone infusion. Also known as the Tei index, the MPI is an index that incorporates both systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function. Systolic dysfunction prolongs preejection (isovolumic contraction time, IVCT) and a shortening of the ejection time (ET). Both systolic and diastolic dysfunction result in abnormality in myocardial relaxation which prolongs the relaxation period (isovolumic relaxation time, IVRT). Normal value for MPI is 0.39+/-0.05 with dilated cardiomyopathy value of MPI at 0.59+/-0.10 (both units on a scale)|Up to 24 hours after start of infusion||||units on a scale||Standard Deviation|Mean
2721272|NCT01088997|Primary|Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min)|The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were determined using a validated high-performance mass spectrometry assay.|End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight)|The pharmacokinetic analysis, including the primary outcome parameter, Clearance, was planned a priori to include all the participants pooled together. A PK analysis by arm wouldn't be appropriate. The randomization arms were only created to explore the secondary clinical and pharmacodynamic outcomes.|||mL/min/3.4 kg||Standard Error|Mean
2721413|NCT01087801|Primary|Endoscopic Sample|"Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8).~(Note- The outcome value is boolean (yes or no) as an answer)."|First 5 minutes after treatment administration|||||||
2721273|NCT01088997|Secondary|Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|Oxygenation Index (mean airway pressure*Fraction of Inspired Oxygen/Partial Pressure of Oxygen in the blood) was calculated at baseline and every 6 hours after start of infusion until 12-24 hours after initiation of milrinone infusion.|for up to 24 hours after start of infusion|OI was calculated every 6 hours after start of infusion for 24 hours.|||units on a scale||Standard Deviation|Mean
2721274|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until 24 Hours After Study Drug Administration (AUC0-24) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2721275|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2721276|NCT01088984|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||hours||Geometric Coefficient of Variation|Geometric Mean
2721277|NCT01088984|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721278|NCT01088984|Secondary|Duration of Response (DOR)|DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|No duration of remission (defined as CR or CRp) analysis was performed for participants in the primary analysis since none achieved remission.||||||
2721279|NCT01088984|Secondary|Best Overall Tumor Response Rate, by Phase|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The safety analysis set included all participants treated at any dose of bendamustine.|||percentage of participants||95% Confidence Interval|Number
2721280|NCT01088984|Secondary|Best Overall Tumor Response Rate|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.|||percentage of participants||95% Confidence Interval|Number
2721281|NCT01088984|Primary|Overall Response Rate (ORR)|ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10^9/L and absolute neutrophil count ≥ 1.0 × 10^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.|Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.|||percentage of participants||95% Confidence Interval|Number
2721694|NCT01085045|Secondary|Peak Change From BL in Inspiratory Capacity on Day 1|Peak change from Baseline in Inspiratory Capacity (IC) on Day 1|Day 1|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2721282|NCT01088984|Primary|Recommended Phase II Dose (RP2D) of Bendamustine|RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m^2 were explored, and escalation to 150 mg/m^2 would only occur if the 120 mg/m^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m^2 dose; de-escalation to the 60 mg/m^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.|Induction Cycle (21- to 35-day cycle)|All participants enrolled in Phase 1 of the study.|||mg/m^2|||Number
2721283|NCT01088815|Secondary|Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Hedgehog Signaling Pathway Downregulation|Hedgehog signaling pathway downregulation as measured by Gli-1 and Patch expression|6 years|Data was not collected for this outcome measure.||||||
2721284|NCT01088815|Secondary|Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Changes in Pancreatic Cancer Stem Cell|Change in number of Pancreatic cancer stem cells in tissue and peripheral blood in tissue biopsy and peripheral blood.|6 years|Peripheral blood data was collected from only 57/72 participants. Tissue biopsy data was not evaluable for analysis due to inadequate biopsy samples for all 23/72 participants who underwent biopsy|||cells||Standard Deviation|Mean
2721285|NCT01088815|Secondary|Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Tumor Response|Number of participants with complete (CR) or partial (PR) response as defined by RECIST criteria.|6 years|Data was evaluable in only 67/72 participants for this outcome measure|||Participants|||Count of Participants
2721286|NCT01088815|Secondary|Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Overall Survival|Total number of months alive.|6 years|Data was evaluable in only 67/72 participants for this outcome measure|||months||95% Confidence Interval|Median
2721287|NCT01088815|Primary|Safety of Combination Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas as Assessed by Number of Grade 3 or 4 Adverse Events|Number of grade 3 or 4 adverse events as defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.0) that occur after Cycle 2, Day 1|6 years||||Grade 3/4 adverse events|||Number
2721288|NCT01088815|Primary|Progression Free Survival With the Combination of GDC-0449 With Gemcitabine and Nab-paclitaxel.|Number of months from time first therapy received to the earliest documented disease progression or death from any cause.|6 years|Data for this outcome measure was evaluable in only in 67/72 participants.|||months||95% Confidence Interval|Median
2721289|NCT01088711|Secondary|Plasma Glucose Concentration|Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.|||mg/dL||95% Confidence Interval|Least Squares Mean
2721290|NCT01088711|Secondary|WAA Total GLP-1 Concentration|WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.|||pmol/L||95% Confidence Interval|Least Squares Mean
2721291|NCT01088711|Secondary|WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration|Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.|||pmol/L||95% Confidence Interval|Least Squares Mean
2721292|NCT01088711|Secondary|Percent Inhibition of DPP-4 After Day 22|Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post dose on Day 22|No data from obese healthy participants (Panel A) were collected after pre-dose on Day 22. Therefore, data are presented only for obese T2D participants (Panel B) 168 hours post-dose on Day 22.|||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
2721293|NCT01088711|Secondary|Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15|Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post-dose on Day 15|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 168 hours post-dose on Day 15 were pooled according to treatment. Predose data from Day 1 were missing from 2 participants.|||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
2721294|NCT01088711|Primary|Number of Participants Withdrawing From Study Therapy Due to an AE||Up to Day 22|AEs were monitored in all obese healthy (Panel A) and T2D (Panel B) participants who received omarigliptin 50 mg or placebo.|||Participants|||Number
2721295|NCT01088711|Primary|Number of Participants Experiencing an Adverse Event (AE)||Up to Day 36|AEs were monitored in all obese healthy (Panel A) and Type 2 diabetes (T2D) (Panel B) participants who received omarigliptin 50 mg or placebo.|||Participants|||Number
2721296|NCT01088672|Secondary|Mortality at 90 Days|All cause mortality through 90 days post procedure.|90-day||||participants|||Number
2721297|NCT01088672|Secondary|Clinical Outcomes at 90 Days|"Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.~mRS 0-2 indicates functional independence 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~https://en.wikipedia.org/wiki/Modified_Rankin_Scale"|90-day||||percentage of subjects with mrs 0-2|||Number
2721298|NCT01088672|Primary|Revascularization Status|"Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure~Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.~Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...~Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment||||percentage of subjects TICI 2 or >|||Number
2721299|NCT01088646|Primary|Percentage of Capsule Placement Success Using PillCam® Express Capsule Endoscopy Delivery System||up to 7 days|||||||
2721300|NCT01088646|Primary|Number of Participants With Successful Capsule Placment Into the Duodenum Using Capsule Delivery System|The number of capsules that successfully were in the duodenum as indicated by video images|up to 7 days||||participants|||Number
2721301|NCT01088529|Secondary|Number of Participants With Prostate-Specific Antigen Response|The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.|Cycle 3 Day 1|"Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2721302|NCT01088529|Secondary|Number of Participants With a Positive Surgical Margin at Radical Prostatectomy|The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.|||participants|||Number
2721303|NCT01088529|Primary|Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)|The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.|||participants|||Number
2721304|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index|The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.|Day 0 (study enrollment)|All enrolled participants who had Duke CAD Index completed.|||units on a scale||Standard Deviation|Mean
2721305|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin||Day 0 (study enrollment)|All enrolled participants who had pre-procedure hemoglobin evaluation.|||grams/deciliter (g/dL)||Standard Deviation|Mean
2721306|NCT01088503|Secondary|Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness||15 months|Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.||||||
2721307|NCT01088503|Secondary|Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events|Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.|Baseline through 15 months|Participants who were treated with prasugrel or clopidogrel.|||percentage of participants||95% Confidence Interval|Number
2721308|NCT01088503|Secondary|Percentage of Participants With MACE Over 1, 6 and 15 Months|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.|Baseline through 1, 6 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2721317|NCT01088464|Primary|PK: t½ of Necitumumab After Multiple Doses|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had t½ values for Day 29 of Cycle 1.|||h||Geometric Coefficient of Variation|Geometric Mean
2721309|NCT01088503|Secondary|Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2721310|NCT01088503|Secondary|Percentage of Participants With Cumulative Severe or Moderate Bleeding Events|Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.|Baseline, 1, 6, 12 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.|||percentage of participants||95% Confidence Interval|Number
2721311|NCT01088503|Primary|Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment|Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.|Day 0 (study enrollment)|All enrolled participants|||participants|||Number
2721312|NCT01088503|Primary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2721313|NCT01088464|Primary|PK: Vss of Necitumumab After Multiple Doses|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Data did not allow calculation of Vss for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Vss values for Day 29 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.|||mL||Geometric Coefficient of Variation|Geometric Mean
2721314|NCT01088464|Primary|PK: Steady-State Volume of Distribution (Vss) of Necitumumab After Single Dose|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Vss was not analyzed for participants in Cohorts 1 and 3 as Vss is derived from AUC (0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Vss values for Day 1 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.|||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2721315|NCT01088464|Primary|PK: CL of Necitumumab After Multiple Doses|CL is defined as the volume of plasma that is cleared of study drug per unit time. Data did not allow calculation of CL for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had CL values for Day 29 of Cycle 1. CL of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2721316|NCT01088464|Primary|PK: Clearance (CL) of Necitumumab After a Single Dose|CL is defined as the volume of plasma that is cleared of study drug per unit time. CL was not analyzed for participants in Cohorts 1 and 3 as CL is derived from AUC(0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received single dose of study drug and had CL values for Day 1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for CL on Day 1 of Cycle 1, due to fraction of data outside tlast >30%|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2721342|NCT01088399|Secondary|Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)||Baseline through 10 years|All participants with baseline and at least 1 post-baseline visit and who provided bone fracture information.|||percentage of participants|||Number
2721318|NCT01088464|Primary|PK: Half-Life (t½) of Necitumumab After a Single Dose|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had t½ values for Day 1 of Cycle 1.|||h||Geometric Coefficient of Variation|Geometric Mean
2721319|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to 336 h Postdose [AUC(0-336)] of Necitumumab After Multiple Doses|Steady state AUC(0-336) values are reported.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had AUC(0-336) values for Day 29 of Cycle 1.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2721320|NCT01088464|Secondary|Immunogenicity (IK): Number of Participants With Treatment-Emergent Anti-IMC-11F8 Antibodies|Treatment-emergent samples were defined as samples which showed at least 4-fold difference (2 dilution increase) at post-baseline in IK titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|For Cohorts 1, 2 and 3: Prior to first infusions of Cycles 1, 2, and 4 and at the 30-day follow-up visit (+7 days) after the last dose of study drug|All participants who received any quantity of study drug.|||participants|||Number
2721321|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of Necitumumab After a Single Dose|AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for all the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|"All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day~1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for AUC(0-∞) on Day 1 of Cycle 1, due to fraction of data outside tlast >30%"|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2721322|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Last Time Point [AUC (0-tlast)] of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day 1 of Cycle 1.|||micrograms*hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2721323|NCT01088464|Primary|PK: Cmin of Necitumumab After Multiple Doses|Cmin was calculated prior to the last dose of the initial 6-week treatment cycle.|Cycle 1; Cohorts 1and 3: prior to fourth infusion. Cohort 2: prior to third infusion|All participants who received multiple doses of study drug and had Cmin serum concentrations prior to last dose of Cycle 1.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2721324|NCT01088464|Primary|PK: Minimum Concentration (Cmin) of Necitumumab After a Single Dose|Cmin is defined as the minimum concentration the drug achieved after administration of first infusion and prior to the administration of second infusion.|Cycle 1; Cohorts 1, 2 and 3: prior to second infusion|All participants who received single dose of study drug and had Cmin serum concentrations analyzed prior to administration of second dose.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2721325|NCT01088464|Primary|PK: Cmax of Necitumumab After Multiple Doses|Cmax at steady state (after the last dose of the initial 6-week treatment cycle).|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Cmax values for Day 29 of Cycle 1.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2721326|NCT01088464|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 hours (h) after end of infusion. Cohort 2: predose, immediately after infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Cmax values for Day 1 of Cycle 1.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2721327|NCT01088464|Primary|Number of Participants With 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Data presented are the number of participants who experienced 1 or more TEAEs or SAEs regardless of causality. An adverse event was considered as TEAE if it occurred any time after the administration of the first dose of study drug or up to 30 days after the last dose of study treatment or if it occurred prior to the first dose and worsened while on treatment. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.|Baseline up to 24 weeks plus 30 days post last dose of study drug|All participants who received any quantity of study drug.|||participants|||Number
2721328|NCT01088438|Primary|Probing for Biomedical Issues|Probability that the learner probes biomedical red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a biomedical red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT|||proportion of encounters|Participants|95% Confidence Interval|Number
2721329|NCT01088438|Primary|Probing for Contextual Issues|Probability that the learner probes contextual red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a contextual red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT|||proportion of encounters|Participants|95% Confidence Interval|Number
2721695|NCT01085045|Secondary|Peak Change From BL in FEV1 on Day 7|Peak change from Baseline (BL) in FEV1 on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2721330|NCT01088438|Primary|Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters)|Probability that the learner writes a correct treatment plan for the standardized patient encounters undertaken at assessment at end of subinternship that include contextual red flags. All learners are scheduled to see 4 encounters, based on combinations of four cases and four potential variants (baseline, biomedical, contextual, biocontextual) with counterbalancing by study month; each has a single contextual variant encounter. Treatment plans are assessed by an investigator blinded to the learner's assignment to intervention or control group.|1 month|ITT. In one case, a participant did not receive a contextual variant encounter because the standardized patient was ill, and this encounter is excluded.|||proportion of contextual encounters|Participants|95% Confidence Interval|Number
2721331|NCT01088412|Secondary|Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses||Baseline through Year 15|All treated participants with available age and calculable follow-up time, and diabetes mellitus (DM), type 1 diabetes mellitus (T1) or type 2 diabetes mellitus (T2). Data was not provided for untreated and unknown treatment groups, and could not be calculated.|||Incident Cases|||Number
2721332|NCT01088412|Secondary|Percentage of Participants With De Novo Neoplasms|Percentage of participants with the development of de novo neoplastic disease with no history of prior neoplasia.|Baseline through Year 15|All SME, GH-treated participants with at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated.|||percentage of participants|||Number
2721333|NCT01088412|Secondary|Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors|Percentage of participants with recurrence/progression of primary neoplastic disease and/or development of secondary neoplasms in childhood cancer survivors.|Baseline through Year 15|All SME, treated participants with previous neoplastic disease and at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated.|||percentage of participants|||Number
2721334|NCT01088412|Secondary|Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency||Baseline, Year 15|All SHOX-D Participants, GH-treated, with available height SDS at baseline and final height. Data was not provided for untreated and unknown treatment groups, and could not be calculated.|||standard deviation score||Standard Deviation|Mean
2721335|NCT01088412|Secondary|Predicted First Year Height Gain Versus Actual First Year Height Gain|The value for predicted and observed is of limited bearing, it is how each participant's predicted versus observed height gain compare and this is best estimated by the R-squared. An estimation parameter would not be a correct format for the R2 data. R2 can take value between 0 and 1 with values closer to 0 representing a poor fit while values closer to 1 representing a perfect fit|Baseline through Year 15|All participants with predicted and actual first year height gain available and TS or GHD diagnosis. Data was not provided for untreated and unknown treatment groups, and could not be calculated.|||R Squared|||Number
2721336|NCT01088412|Secondary|Percentage of Participants With Defects in Genes Associated With Pituitary Development|Percentage of participants with genetic defects associated with pituitary development. Genes included but were not limited to GH1, Growth hormone releasing hormone receptor (GHRHR), Homeobox gene expressed in embryonic stem cells (HESX1), LIM homeobox 3 (LHX3), POU domain, class 1, transcription factor 1 (POU1F1), and Prophet of Pit1 (PROP1).|Baseline through Year 15|All SME participants (including treated, untreated, and unknown groups) with available results of DNA (deoxyribonucleic acid) analysis available and GHD diagnosis.|||percentage of participants|||Number
2721337|NCT01088412|Primary|Final Height (FH) Gain by Diagnostic Group|The standard deviation score (SDS) reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.|Baseline through Year 15|All treated participants who reached final height (at least 1: closed epiphyses, height velocity <2 centimeters per year, or last bone age >14 years [girls] or >16 years [boys]) with baseline height SDS and final height available. Data was not provided for untreated and unknown treatment groups, and could not be calculated.|||standard deviation score||Standard Deviation|Mean
2721338|NCT01088412|Primary|Primary Malignancies in Participant Without Previous Cancer History|Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.|Year 15|All treated participants with available age, gender, and at least one follow-up excluding participants with previous cancer cases. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated.|||Incident Cases|||Number
2721339|NCT01088412|Primary|Type 2 Diabetes Mellitus in GH-treated Participants||Year 15|All treated participants with available age and calculable follow-up time. The treated participants were not compared with untreated but with rates from general population registries. The untreated participants predominantly contained neoplasm or SHOX deficient diagnoses, therefore had significant baseline differences from treated participants.|||Incident Cases|||Number
2721340|NCT01088399|Other Pre-specified|Number of Participants Who Died While in the Study||Study enrollment up to approximately 10 years|All participants with baseline and at least 1 post-baseline visit.|||participants|||Number
2721341|NCT01088399|Secondary|Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).|QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction).|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and has a Total Z Score.|||Z-score||Standard Deviation|Mean
2721343|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Waist Circumference|Change in waist circumference was used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had waste circumference data.|||centimeters (cm)||Standard Deviation|Mean
2721344|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides|Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had cholesterol or triglyceride data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2721345|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)|Change in SBP and DBP were used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and BP data.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2721346|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)|Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had BMI data.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2721347|NCT01088399|Primary|Clinically Significant Adverse Events|A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.|Baseline to study completion (approximately 10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated).|||percentage of participants|||Number
2721348|NCT01088295|Primary|Median Change in Visceral Adipose Tissue (VAT) Volume|VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography|Baseline and 24 weeks|as-treated analysis|||cm^2||Inter-Quartile Range|Median
2721349|NCT01088243|Secondary|Lung Function|Secondary outcomes include changes in lung function, which will be assessed with Forced expiratory volume in 1 second percent predicted (FEV1), Forced vital capacity percent predicted (FVC) and Diffusing capacity percent predicted (DLCO).|baseline and week 6|One participant did not complete follow up in Mesalamine group. However, below is a summary of what data was received.|||percentage of predicted value||Standard Deviation|Mean
2721350|NCT01088243|Secondary|Glucocorticoid Receptors|Secondary outcomes include changes in glucocorticoid receptors modification in PBMCs and BAL cells.|baseline and week 6|We were not able to perform due to insufficient samples and data collected from each participant to summarize changes.||||||
2721351|NCT01088243|Secondary|HDAC2 Levels|Secondary outcomes include changes in HDAC2 levels|baseline and week 6|We were not able to perform due to insufficient samples and data collected from each participant to summarize changes in HDAC2 levels.||||||
2721352|NCT01088243|Secondary|Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6|Secondary outcomes include changes in steady-state GSH levels in beryllium specific CD4+ T cell in bronchoalveolar lavage fluid (BALF)|baseline and week 6|We did not receive enough cells from participants to be able to run experiments on all. However, below is a summary of what data was received.|||mmol/mg||Standard Deviation|Mean
2721353|NCT01088243|Secondary|Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa)|Secondary outcomes include changes in bronchoalveolar lavage (BAL) tumor necrosis factor alpha (TNFa)|baseline and week 6|We did not have sufficient cells to run experiments on all participants. However, below is a summary of what data was received.|||pg/ml||Standard Deviation|Mean
2721354|NCT01088243|Primary|Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6|"Primary endpoints are beryllium proliferation responses (BeLPT) in PBMCs (peripheral blood mononuclear cells) and BAL (bronchoalveolar lavage) cells. The BeLPT is a blood test that measures the immune response to beryllium exposure. If immune cells multiply in response to beryllium, this is considered an abnormal test results. If immune cells do not multiple, this is considered a normal test results. Results are reported as stimulation index, which is a ratio of the number of cells grown with beryllium compared to the number of cells grown without beryllium. A value of 2.5 or less is considered normal, and a value greater than 2.5 is abnormal."|baseline and week 6|Because bronchoscopy was not required for participation, only three placebo and six 5-ASA-treated subjects underwent bronchoscopy and is reported under BAL.|||Stimulation index||Standard Deviation|Mean
2721355|NCT01087996|Secondary|Change in New York Heart Association Class at 12-months||12 months||||participants|||Number
2721356|NCT01087996|Secondary|Change in Minnesota Living With Heart Failure Total Score|The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months||||units on a scale||95% Confidence Interval|Mean
2721357|NCT01087996|Secondary|Change in Distance Walked in 6-minutes From Baseline.||12-months||||meters||95% Confidence Interval|Mean
2721358|NCT01087996|Secondary|CT Measure of Scar Size as % of LV Mass||Baseline Month 13 post-catheterization||||percent||95% Confidence Interval|Mean
2721359|NCT01087996|Secondary|CT Measure of End Systolic Volume||Baseline Month 13 post-catheterization||||ml||95% Confidence Interval|Mean
2721360|NCT01087996|Secondary|CT Measure of End Diastolic Volume||Baseline Month 13 post-catheterization||||ml||95% Confidence Interval|Mean
2721361|NCT01087996|Secondary|CT Measure of Left Ventricular Ejection Fraction||Baseline Month 13 post-catheterization||||percent||95% Confidence Interval|Mean
2721362|NCT01087996|Secondary|CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month|Percentage change from 13-months post-catheterization to baseline.|Baseline Month 13 post-catheterization||||percent change from baseline||95% Confidence Interval|Mean
2721364|NCT01087970|Other Pre-specified|Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)|Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.|From enrollment to 30 days post-treatment discontinuation up to 26.4 months|All enrolled participants who received at least 1 dose of any study drug.|||participants|||Number
2721365|NCT01087970|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.|||units on a scale||Standard Deviation|Mean
2721366|NCT01087970|Secondary|Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.|||units on a scale||Standard Deviation|Mean
2721367|NCT01087970|Secondary|Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)|PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)|All treated participants excluding those from a noncompliant study site.|||percentage of participants||95% Confidence Interval|Number
2721368|NCT01087970|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.|From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.|||months||95% Confidence Interval|Median
2721369|NCT01087970|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.|||months||95% Confidence Interval|Median
2721370|NCT01087957|Secondary|Berg Balance Scale|The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|6 months||||units on a scale||Standard Error|Mean
2721371|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Stair Time|The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .|6 months||||seconds||Standard Error|Mean
2721372|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Obstacle Course|The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.|6 months||||seconds||Standard Error|Mean
2721373|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Timed up and Go|The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.|6 months||||seconds||Standard Error|Mean
2721374|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Carpet Time|The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .|6 months||||seconds||Standard Error|Mean
2721375|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Floor Time|The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.|6 months||||seconds||Standard Error|Mean
2721376|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Total Score|The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.|6 months||||seconds||Standard Error|Mean
2721377|NCT01087957|Secondary|Six Minute Walk Test||6 months||||meters||Standard Error|Mean
2721378|NCT01087957|Primary|Device Related Serious Adverse Events|The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).|6 months|Intention to treat|||number of device related SAEs|||Number
2721379|NCT01087957|Primary|Stroke Impact Scale (SIS) Composite Score|The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.|6 months|Intention to treat|||points||Standard Error|Mean
2721380|NCT01087957|Primary|Gait Velocity|Improved ambulation status, specific to increase in gait velocity (m/s)|6 months|Intention to treat|||m/sec||Standard Error|Mean
2721381|NCT01087944|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Upto Day 36|The ITT population included all participants who received at least one injection|||participants|||Number
2721382|NCT01087944|Secondary|Number of Participants With Abnormalities in Electrocardiograms|A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721383|NCT01087944|Secondary|Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure|The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721384|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Creatinine|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter [umol/L]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721385|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721386|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre [U/L]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721551|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721387|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721388|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721389|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10*9/L), for WBC was 3.0-18.0 (10*9/L), for Basophils was 0.00-0.40 (10*9/L), for Eosinophil was 0.00-0.90 (10*9/L), for Lymphocytes was 0.70-7.60 (10*9/L), Monocyte was 0.00-1.70 (10*9/L), and Neutrophil 1.50-9.25 (10*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721390|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematocrit|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721391|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter [g/L]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
2721392|NCT01087944|Primary|Feasibility of Peginterferon Alfa-2a Administration by Autoinjector|"The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a Yes or No response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?"|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The intent-to-treat (ITT) population included all participants who received at least one injection|||participants|||Number
2721393|NCT01087931|Secondary|Narcotic Use, Final Follow up|Number of participants using narcotics for pain|about 18 to 20 weeks after surgery||||Participants|||Count of Participants
2721394|NCT01087931|Secondary|Narcotic Use, 1st Follow up|Number of participants using narcotics for pain|about 4 to 5 weeks after surgery||||Participants|||Count of Participants
2721395|NCT01087931|Primary|Pain, Cumulative Visual Analog Score, Final Follow up|Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.|about 18 to 20 weeks after surgery|Original study data has been lost. Estimated values obtained from a figure describing the results in the study results publication are reported in the data table.|||units on a scale||Standard Deviation|Mean
2721396|NCT01087931|Primary|Pain, Cumulative Visual Analog Score, 1st Follow Up|Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.|about 4 to 5 weeks after surgery||||units on a scale||Standard Deviation|Mean
2721397|NCT01087918|Secondary|Figure of Eight Test|The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||meters per second||Standard Deviation|Mean
2721398|NCT01087918|Primary|10 Meter Walking at Maximal Speed|The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||meters per second||Standard Deviation|Mean
2721399|NCT01087918|Secondary|Falls Efficacy Scale|The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
2721400|NCT01087918|Secondary|Response Time of the Lower Extremities|We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)||||milliseconds||Standard Deviation|Mean
2721401|NCT01087918|Secondary|Pain on a Visual Analogue Scale|Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.|||units on a scale||Standard Deviation|Mean
2721402|NCT01087918|Secondary|Manual Muscle Test of the Lower Extremity|With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
2721403|NCT01087918|Secondary|Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis|Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)||||milliseconds||Standard Deviation|Mean
2721404|NCT01087918|Secondary|Spinal Cord Independence Measure III|The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
2721405|NCT01087918|Secondary|Berg Balance Scale|The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
2721406|NCT01087918|Secondary|Walking Index for Spinal Cord Injury II|The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
2721407|NCT01087918|Primary|10 Meter Walking at Preferred Speed|The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||meters per second||Standard Deviation|Mean
2721408|NCT01087905|Secondary|Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group|For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.|26 weeks after the target quit smoking date|"No a priori power analysis was conducted for this secondary outcome."|||U.S. Dollars|||Number
2721409|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.|||Percentage of participants not smoking|||Number
2721410|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Intervention|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.|||Percentage of participants not smoking|||Number
2721411|NCT01087814|Primary|Serum Levels of Efavirenz|Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.|5th day of taking drug||||ng/mL||Standard Deviation|Mean
2721412|NCT01087801|Primary|Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).|Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.|First 5 minutes after treatment administration||||Participants|||Number
2721696|NCT01085045|Secondary|Peak Change From BL in FEV1 on Day 1|Peak change from Baseline in FEV1 on Day 1|Day 1|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2721414|NCT01087788|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48|"Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome).~For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6."|From Baseline to Week 48|Randomized Set (RS) with imputation: for subjects who withdrew for any reason, or subjects with missing Week 48 measurements, and for all placebo subjects after the switch to CZP, Week 48 scores are linearly extrapolated from the last two available radiographs prior to early withdrawal or Week 24 or before receiving CZP.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721415|NCT01087788|Secondary|Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline|The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
2721416|NCT01087788|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721417|NCT01087788|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 24|ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
2721418|NCT01087788|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with imputation: for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, scores are linearly extrapolated from the last two radiographs prior to early withdrawal or Week 24 or before receiving CZP.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721419|NCT01087788|Primary|American College of Rheumatology 20 (ACR20) Response at Week 12|ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
2721420|NCT01087775|Secondary|Social and Occupational Functioning and Quality of Life Scores at 6 Months|"To measure social and occupational functioning, we used the World Health Organisation Quality of Life Assessment (WHOQOL-BREF) validated to detect intervention-related change in quality of life.~Range of post-treatment domain scores:~WHOQOL physical domain: 7-35; WHOQOL psychological domain: 6-30; WHOQOL social relationships domain: 2-10; WHOQOL environment domain: 8-40.~Higher scores indicate better quality of life outcomes."|6 month follow-up|Challenges in recruitment/retention led us to redesign the study as an open trial and the limitation is that there is a small number of subjects who completed the study.|||score on a scale||Standard Deviation|Mean
2721421|NCT01087775|Primary|Change Scores of Standard (Untrained) Neurocognitive Measures (Verbal Memory, Learning and Sustained Attention)|We presented change scores (6-month scores minus baseline scores) outcomes of 10 measures of neurocognitive measures (together with ranges): the Wechsler Memory Scale (WMS-IV) Paired Associates immediate and delayed memory (range: 1-19), Rey Auditory Verbal Learning Test (RAVLT) total score (range: 0-100) and delayed score (range: 0-20), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span (range: 0-48), Wechsler Adult Intelligence Scale (WAIS-IV) Letter Number Sequencing (range: 1-19), Auditory Consonant Trigrams (ACT) raw score (range: 0-60), Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition (range: 1-19), and the Brief Visual Memory Test revised (BVMT-R) total T score and Delayed T score (range: 20-80). Higher scores mean better cognitive functioning outcomes.|6-month follow-up|Challenges in recruitment/retention led us to redesign the study as an open trial and the limitation is that there is a small number of subjects who completed the study.|||score on a scale||Full Range|Mean
2721422|NCT01087762|Secondary|Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12|The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2721423|NCT01087762|Secondary|Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12|The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2721424|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24|The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721425|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12|The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721426|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721464|NCT01086969|Primary|Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 to 30 post-vaccination|Four-fold antibody increase were determined in the immunogenicity analysis set|||Percentage of Participants|||Number
2721427|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721428|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|"The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (Easy) to 10 (Impossible). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721429|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12|"The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (Easy) to 10 (Impossible). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.|||units on a scale||95% Confidence Interval|Least Squares Mean
2721430|NCT01087762|Secondary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:~Patient's Global Assessment of Disease Activity~Pain assessment (total spinal pain)~Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))~Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)~and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
2721431|NCT01087762|Primary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:~Patient's Global Assessment of Disease Activity~Pain assessment (total spinal pain)~Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))~Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)~and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
2721432|NCT01087736|Other Pre-specified|PTSD Symptom Severity|The average PTSD symptom severity score during treatment (weeks 4, 8, 12). The PTSD Checklist (PCL) is a self-report measure of the 17 DSM-IV symptoms of PTSD. Respondents rate on a scale from 1 (not at all) to 5 (extremely) how much they were bothered by each symptom in the past month. A total symptom severity score (range = 17 - 85) can be obtained by summing the scores from the 17 items, with higher scores indicating greater severity of PTSD symptoms. Mean scores may be calculated for subscales of intrusion (range 5-25), avoidance (range 7-35), and arousal (range 5-25).|Weeks 4, 8, 12||||units on a scale||Standard Deviation|Mean
2721433|NCT01087736|Primary|Percent Drinking Days (%DD)|"Alcohol consumption was assessed at baseline and weekly during the treatment phase (12 weeks) using the Time Line Follow Back (TLFB) interview which yields number of days of alcohol use (DD).~DD: day on which alcohol was consumed Standard alcoholic drink defined as containing 13.6 g of pure alcohol."|Weekly, weeks 1-12, average||||percent days in a week||Standard Deviation|Mean
2721434|NCT01087723|Secondary|The Incidence of Stroke|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721435|NCT01087723|Secondary|The Incidence of Thrombocytopenia|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721436|NCT01087723|Secondary|The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721437|NCT01087723|Secondary|The Incidence of Minor Bleeding: TIMI and GUSTO|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721438|NCT01087723|Secondary|The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721439|NCT01087723|Secondary|The Incidence of Death at 1 Year|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time.|Within 1 Year|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721440|NCT01087723|Secondary|The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)|Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721441|NCT01087723|Secondary|The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding|A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721442|NCT01087723|Primary|The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding|A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
2721443|NCT01087541|Secondary|Systolic and Diastolic Blood Pressure||6 months||||mmHg||Standard Deviation|Mean
2721444|NCT01087541|Secondary|Blood Pressure ( Systolic / Diastolic )||Baseline||||mmHg||Standard Deviation|Mean
2721445|NCT01087541|Primary|Glycosylated Haemoglobin A1c at 6 Months|Glycohemoglobin A1c at 6 months.|6 months||||Percentage||Standard Deviation|Mean
2721446|NCT01087541|Secondary|BMI at 6 Months||6 months||||kg/m2||Standard Deviation|Mean
2721447|NCT01087541|Secondary|BMI ( Body Mass Index ) at Start||Baseline||||kg/m2||Standard Deviation|Mean
2721448|NCT01087541|Primary|Glycosylated Haemoglobin A1c at Start||Baseline||||Percentage||Standard Deviation|Mean
2721449|NCT01087528|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:~poor cleansing level (Large amount of fecal residue.)~fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)~good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)~excellent cleansing level (No more than small bits of adherent feces.)"|within 7 days|||||||
2721450|NCT01087528|Primary|Specificity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|within 7 days|||||||
2721451|NCT01087528|Primary|Sensitivity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category .The false negative rate is equal to 1 - sensitivity and indicated the percentage of polyps missed by capsule endoscopy.|within 7 days||||percentage of participants||95% Confidence Interval|Number
2721452|NCT01087502|Secondary|Plasma Concentration of Linagliptin at Trough|Trough levels of concentration of Linagliptin in plasma.|Week 12, 24 and 52|FAS original results (OR). Original results analysis means that data is analyzed exactly as observed, values after rescue medication are not set to missing and no imputation rule is applied for replacing the missing values.|||Nmol/L||Geometric Coefficient of Variation|Geometric Mean
2721453|NCT01087502|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%|The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline, week 12 and week 52|FAS with non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.|||percentage of patients|||Number
2721454|NCT01087502|Secondary|Percentage of Patients With HbA1c <6.5%|The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=6.5% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.|||percentage of patients|||Number
2721455|NCT01087502|Secondary|Percentage of Patients With HbA1c <7.0%|The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.|||percentage of patients|||Number
2721456|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline Over Time|This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.|||mg/dL||Standard Deviation|Mean
2721457|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|One patient in the Placebo/Glimepiride arm and one patient in the Linagliptin arm without FPG on-treatment value. Results do not contain data of patients from the excluded study site.|||mg/dL||Standard Error|Mean
2721458|NCT01087502|Secondary|HbA1c Change From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.|||Percent||Standard Deviation|Mean
2721459|NCT01087502|Primary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.|Baseline and week 12|"FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.~Results for primary endpoint below are the ones reproduced without patients from the excluded study site."|||Percent||Standard Error|Mean
2721460|NCT01087489|Secondary|Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage|"Presence of corneal staining after the injection:~Quadrants of fluorescein staining: 0 1 2 3 4~Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion~Size of subconjunctival hemorrhage:~in clock hours"|within 10 minutes of the injection|all eyes for which data were available were included|||units on a scale|Participants|Standard Deviation|Mean
2721461|NCT01087489|Secondary|Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg|intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.|immediately after injection, at 5, 10, 15 minutes|48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively|||mmHg|Participants|Standard Deviation|Mean
2721462|NCT01087489|Primary|Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection|"Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe~Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied"|immediately after injection, 1- hour later, and next day|all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day|||units on a scale||Standard Deviation|Mean
2721463|NCT01086969|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination|Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia|Day 0 to 7 post-vaccination|Safety parameters were assessed in the safety analysis set|||Participants|||Number
2721465|NCT01086969|Primary|Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 and Day 30 post-vaccination|Geometric mean titers were determined in the immunogenicity analysis set|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
2721466|NCT01086969|Primary|Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination|Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.|Baseline and 21 days post-vaccination|Menactra vaccine antibody titers were determined in the immunogenicity analysis set.|||Participants|||Number
2721467|NCT01086852|Primary|Number of Participants With Degree of Bleeding Control Rated as Excellent.|"Investigators made an overall assessment of FACTOR X in controlling bleeding at the End of Treatment Assessment. The degree of bleeding control was rated as excellent, good, poor or unassessable, in accordance with the following criteria listed below:~Excellent -Parameters were similar to those in subjects without a bleeding disorder.~Good -Parameters were inferior to those in subjects without a bleeding disorder, but no other factor X containing agents were required to restore haemostasis.~Poor - Blood loss was excessive (defined as more than twice the pre defined amount that would be expected in a subject without a bleeding disorder for this type of surgery) and/or Haemostasis was not achieved and/or Additional factor X containing agents were required to restore haemostasis.~Unassessable -Efficacy was not possible to assess, or Additional factor X containing agents (excluding blood transfusions) were required before efficacy of FACTOR X could be assessed."|During and till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||Participants|||Number
2721468|NCT01086852|Secondary|Dose Per Infusion (IU/kg)|weight adjusted dose per infusion until a subject was no longer at risk of bleeding due to surgery|before surgery, during the post operative period|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||IU/kg||Full Range|Median
2721469|NCT01086852|Primary|Change of Haemoglobin From Pre-surgery Till End of Treatment|The subject's haemoglobin was measured pre operatively, within 2 hours post operatively and at the End of Treatment Assessment. Changes in the subject's haemoglobin from pre to post operatively and from post operatively to the End of Treatment Assessment were assessed, taking into account the volume of fluid infused into the subject during the intervening periods, any blood transfusions in the intervening periods, the subject's haematocrit at the same time points and the subject's pre dose serum ferritin|2 hrs pre-operatively till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||g/L||Standard Deviation|Geometric Mean
2721470|NCT01086852|Primary|Number of Post Operative Bleeding Episodes (See Table Below)|Bleeding was assessed at least once each day by the investigator, more frequently if indicated by the severity of the operation or the subject's response. This included all bleeding episodes from the end of the surgical procedure until the subject was no longer at risk of bleeding due to surgery|End of surgery till end of study|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||number of bleeds|||Number
2721471|NCT01086852|Primary|Requirement for Blood Transfusion|Number of blood transfusions required (units of packed red blood cells or units of whole blood) or infusion of autologous red cells during and after surgery|during and after surgery|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||number of transfusions|||Number
2721472|NCT01086852|Primary|Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder.|The investigator's estimation of the volume of blood loss during surgery compared to the volume of blood loss expected in patients without a bleeding disorder undergoing the same surgical procedure and reported as greater than, equal to or less than.|After wound closure|All subjects treated with FACTOR X|||participants|||Number
2721473|NCT01086852|Secondary|Incremental Recovery After Bolus Dose of FACTOR X|"Incremental Recovery of FX:C after the Pre surgery Bolus Infusion The factor X increment is calculated by subtracting the pre-infusion factor X level from the post-dose value.~Incremental recovery is calculated by FX increment (IU/dL)/ FX dose (IU/kg)"|incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||IU/dL per IU/kg||Standard Deviation|Geometric Mean
2721474|NCT01086852|Primary|Clinical Estimation of Volume of Blood Loss During Surgery|"As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count.~The clinical assessment was rated as follows:~Blood loss less than expected~Blood loss as expected~Blood loss more than expected~Blood loss excessive (defined as more than twice the pre defined amount that would be expected in a normal patient for this type of surgery)"|Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X.|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||ml||Standard Deviation|Geometric Mean
2721475|NCT01086761|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|Safety Population included all treated participants.|||Participants|||Number
2721476|NCT01086761|Secondary|Maximum Serum Concentration (Cmax) of MP0112 at Day 3|Blood samples were collected for MP0112 levels on Day 3. The serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory and were analyzed for MP0112 levels using an enzyme-linked immunosorbent assay. Maximum concentration at Day 3 was calculated.|Day 3|Pharmacokinetic (PK) Population included all treated participants with PK data.|||Nanomolar (nM)|||Number
2721477|NCT01086761|Secondary|Area of Lesion as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye after fluorescein application at Baseline and Week 4. A lower number indicated a smaller lesion area.|Baseline, Week 4|All treated participants with data available for analysis.|||mm^2||Standard Deviation|Mean
2721478|NCT01086761|Secondary|Area of Leakage as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye 10 minutes after fluorescein application at Baseline and Week 4. A lower number indicated a smaller area of leakage.|Baseline, Week 4|All treated participants.|||mm^2||Standard Deviation|Mean
2721479|NCT01086761|Secondary|Change From Baseline in Central Area Retinal Thickness|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Week 4. A negative change from Baseline indicated improvement (less retinal thickness). A positive change from Baseline indicated worsening (definite retinal thickening).|Baseline, Week 4|All treated participants.|||μm||Standard Deviation|Mean
2721480|NCT01086761|Secondary|Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 4. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision. Stable or Improved BCVA was defined as a loss of <15 letters read correctly compared to Baseline.|Baseline, Week 4|All treated participants.|||Percentage of participants|||Number
2721481|NCT01086761|Primary|Maximal Tolerated Dose (MTD) Following a Single Injection|MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity.|16 weeks|All treated participants.|||mg|||Number
2721482|NCT01086605|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 1 year after treatment||||Participants|||Count of Participants
2721483|NCT01086605|Secondary|Duration of Response|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented at each dose level. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier at each dose level.|Up to 5 years||||months||Full Range|Mean
2721484|NCT01086605|Secondary|Overall Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier at each dose level.|Up to 5 years||||months||95% Confidence Interval|Median
2721485|NCT01086605|Secondary|6-month Progression-free Survival Rate|The 6-month progression free survival (6-mo PFS) rate is the proportion of efficacy-evaluable patients progression-free 6 months from registration. The 6-mo PFS rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study. Patients who died without documentation of progression will be considered to have progressed on the date of their death. The true 6-mo PFS rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration at each dose level. Binomial confidence intervals for 6-mo PFS rate will be constructed for each dose level. Progression is defined using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1).|At 6 months||||proportion||95% Confidence Interval|Number
2721486|NCT01086605|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression one day post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier at each dose level. Progression is defined using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1).|Up to 5 years||||months||95% Confidence Interval|Median
2721498|NCT01086423|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2721552|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721487|NCT01086605|Primary|Proportion of Confirmed Tumor Responses (Complete or Partial Response)|The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to <1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.|Up to 5 years||||proportion||95% Confidence Interval|Number
2721488|NCT01086475|Primary|Social Responsiveness Scale (SRS) at Follow-Up|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:~0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Week 22|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.|||units on a scale||Standard Deviation|Mean
2721489|NCT01086475|Secondary|Clinical Global Impressions Improvement Scale Responder Analysis|"The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as much or very much improved defined as responders and all other classifications will be regarded as non-responders."|Week 11|Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.|||percentage of participants|||Number
2721490|NCT01086475|Primary|Social Responsiveness Scale (SRS) Change|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:~0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Baseline and Week 11|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.|||units on a scale||Standard Deviation|Mean
2721491|NCT01086423|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 4/5)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2721492|NCT01086423|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period after any dose|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2721493|NCT01086423|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2721494|NCT01086423|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2721495|NCT01086423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2721496|NCT01086423|Secondary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
2721497|NCT01086423|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2721499|NCT01086423|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens|"Vaccine response was defined as:~For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.~For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination."|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2721500|NCT01086423|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2721501|NCT01086423|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2721502|NCT01086423|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2721503|NCT01086410|Secondary|Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline|Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Beats per minute||Standard Deviation|Mean
2721504|NCT01086410|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline|SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2721505|NCT01086410|Secondary|Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2721506|NCT01086410|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2721507|NCT01086410|Secondary|Change From Baseline in Albumin and Total Protein Values at Day 42/EW|Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter||Standard Deviation|Mean
2721518|NCT01086410|Secondary|Cmax for FF on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2721508|NCT01086410|Secondary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW|Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2721509|NCT01086410|Secondary|Change From Baseline in Hematocrit Values at Day 42/EW|Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1||Standard Deviation|Mean
2721510|NCT01086410|Secondary|Change From Baseline in Hemoglobin Values at Day 42/EW|Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2721511|NCT01086410|Secondary|Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW|Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2721512|NCT01086410|Secondary|Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/Early Withdrawal (EW)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage||Standard Deviation|Mean
2721513|NCT01086410|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Day 42 (Visit 5)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug.|||Participants|||Number
2721514|NCT01086410|Secondary|Tmax and Tlast of VI at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
2721515|NCT01086410|Secondary|Cmax for VI on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2721516|NCT01086410|Secondary|AUC(0-t) for VI on Day 42|Area under the concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||picograms*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
2721517|NCT01086410|Secondary|Tmax and Tlast of FF at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
2721519|NCT01086410|Secondary|AUC(0-t) and AUC(0-24) for FF on Day 42|Area under the plasma drug concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
2721520|NCT01086410|Secondary|Plasma FF and VI Pharmacokinetic (PK) Concentration|Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 42|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2721521|NCT01086410|Secondary|Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|Urine Cortisol (UC) Population: all participants in the ITT Population who did not have protocol deviations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that would affect the interpretation of the results.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
2721522|NCT01086410|Secondary|Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42|Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
2721523|NCT01086410|Secondary|Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42|Area under the plasma drug concentration-time (AUC[0-24 hour]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
2721524|NCT01086410|Primary|Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42|"Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline."|Day -1/1 (Baseline) and Day 42|Serum Cortisol (SC) Population: all participants in the Intent-to-Treat Population who did not have protocol deviations that were considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors affecting results interpretation. Only those participant available at the specified time points were analzyed.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
2721525|NCT01086384|Secondary|Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36|Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.|Baseline and Week 36|ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed.|||Liters||Standard Deviation|Least Squares Mean
2721526|NCT01086384|Secondary|Number of Severe Asthma Exacerbations|A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.|Baseline to Follow-up (up to 76 weeks of treatment)|ITT Population|||Severe asthma exacerbations|||Number
2721543|NCT01086228|Secondary|Number of Participants With All Deaths and All MI||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721527|NCT01086384|Primary|Number of Participants With 1 or More Severe Asthma Exacerbations|Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.|Baseline to Follow-up (up to 76 weeks of treatment)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.|||participants|||Number
2721528|NCT01086358|Secondary|Favorable Response on Migraine-ACT|The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments.|6 months||||percentage of favorable responses||95% Confidence Interval|Mean
2721529|NCT01086358|Secondary|Lost Activity Time|This outcome measure was lost activity time as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.|6 Months|This includes all patients that completed all study visits are included in this efficacy analysis|||hours||95% Confidence Interval|Mean
2721530|NCT01086358|Secondary|Lost Workplace Productivity|This outcome measure was lost workplace productivity as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.|6 months|This includes all patients that completed all study visits are included in this efficacy analysis|||hours||95% Confidence Interval|Mean
2721531|NCT01086358|Primary|Workplace Productivity and Activity Impairment Scale (WPAI).|The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.|6 months|This includes all patients that completed all study visits are included in this efficacy analysis|||hours||95% Confidence Interval|Mean
2721532|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and CI-TLR||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721533|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and CI-TLR||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721534|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and CI-TLR||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721535|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and TLR||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721536|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and TLR||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721537|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and TLR||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721538|NCT01086228|Secondary|Number of Participants With All Deaths, All MI and All Revascularization||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721539|NCT01086228|Secondary|Number of Participants With All Deaths, All MI and All Revascularization||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721540|NCT01086228|Secondary|Number of Participants With All Deaths, All MI and All Revascularization||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721541|NCT01086228|Secondary|Number of Participants With All Deaths and All MI||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721542|NCT01086228|Secondary|Number of Participants With All Deaths and All MI||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721553|NCT01086228|Secondary|Number of Participants With Cardiac Death and All MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721554|NCT01086228|Secondary|Number of Participants With Cardiac Death and All MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721555|NCT01086228|Secondary|Number of Participants With Cardiac Death and All MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721556|NCT01086228|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721557|NCT01086228|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721558|NCT01086228|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721559|NCT01086228|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721560|NCT01086228|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|From 1 year to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721561|NCT01086228|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2722000|NCT01083186|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12|The CRP normal range was 0-0.6 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2721562|NCT01086228|Secondary|Number of Participants With Myocardial Infarctions (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721563|NCT01086228|Secondary|Number of Participants With Myocardial Infarctions (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 1 year to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721564|NCT01086228|Secondary|Number of Participants With Myocardial Infarctions (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721565|NCT01086228|Secondary|Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721566|NCT01086228|Secondary|Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|From 1 to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721567|NCT01086228|Secondary|Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721568|NCT01086228|Secondary|Acute Success|"Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met:~Stent was successfully delivered to the intended location~Stent was successfully deployed at the intended location~Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure."|On day 0 (Immediately post-index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of stents|stents||Number
2721569|NCT01086228|Secondary|Net Gain|Net Gain = Acute Gain - Late Loss, paired analysis only.|On day 0 after procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||millimeters|lesions|95% Confidence Interval|Mean
2721570|NCT01086228|Secondary|Late Loss|Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].|On day 0 after procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||millimeters|lesions|95% Confidence Interval|Mean
2721571|NCT01086228|Secondary|Acute Gain|The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).|On day 0 after procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||millimeters|lesions|95% Confidence Interval|Mean
2721572|NCT01086228|Secondary|Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|At 8 months|Eight-month follow-up angiograms for 1,309 lesions in 1,085 patients were assessed by the core laboratory.|||Percent Diameter stenosis|lesions|Standard Deviation|Mean
2721573|NCT01086228|Secondary|Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|On day 0 after procedure|Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.|||Percent Diameter stenosis|lesions|Standard Deviation|Mean
2721574|NCT01086228|Secondary|Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Baseline|Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.|||Percent Diameter stenosis|lesions|Standard Deviation|Mean
2721575|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 4 years to 5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721576|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 3 years to 4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721577|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721578|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 1 year to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721579|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From post-procedure to 1 year||||participants|||Number
2721580|NCT01086228|Primary|Number of Participants With Stent Thrombosis (ST) as Per ARC Definition|"Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.~Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up"|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721581|NCT01086228|Primary|Number of Participants With Stent Thrombosis (ST) as Per ARC Definition|"Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.~Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up"|From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2721582|NCT01086228|Primary|Number of Participants With Stent Thrombosis (ST) as Per ARC Definition|"Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.~Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up"|Post Procedure to 1 Year||||participants|||Number
2721583|NCT01086215|Secondary|Concomitant Treatments Used With the AngioJet® System|The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure|Day 1||||participants|||Number
2721584|NCT01086215|Primary|Rethrombosis|The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.|3 Month , 6 Month and 12 Month Follow Up||||participants|||Number
2721585|NCT01086215|Primary|Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician.~complete occlusion (>90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length)~patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value."|Day 1|Intention to Treat (ITT)|||Units on a Scale||Standard Error|Mean
2721586|NCT01086033|Secondary|Percentage of Participants Who Missed at Least One Dose of Humira|Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.|Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2721672|NCT01085214|Secondary|Progression Free Survival (PFS)|Median PFS in months. Progressive Disease (PD): Increase of >= 25% from baseline. Estimated using the method of Kaplan-Meier.|From registration to progression or death, assessed up to 2 years|All participants who received study treatment|||months||Full Range|Median
2721587|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 70 Response|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR70 could be calculated at each time point."|||participants|||Number
2721588|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR50 could be calculated at each time point."|||participants|||Number
2721589|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR20 could be calculated at each time point."|||participants|||Number
2721590|NCT01086033|Primary|European League Against Rheumatism (EULAR) Response|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate EULAR Response is defined as either:~an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or~an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either:~an improvement (decrease) in the DAS28 of ≤ to 0.6, or~an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|Safety population;|||participants|||Number
2721591|NCT01086033|Primary|Disease Activity Score (DAS) 28 Over Time|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
2721592|NCT01086033|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant."|3 years|The safety population, including all patients that received at least one dose of the study drug.|||participants|||Number
2721593|NCT01085968|Secondary|Symbol Digit Modality Test (SDMT)|"Symbol Digit Modality Test (SDMT): Participants are given a key of numbers (1-9) corresponding to symbols for reference.~Task: Participants are given a page of symbols and are instructed to say aloud the number corresponding to each symbol on the page.~This task is timed for completion and the score is reported as the number of symbol to number matching correct in 90 seconds."|time of enrollment and 2 months following enrollment (before and after training)||||Number of Correct Matches in 90 seconds||Standard Deviation|Mean
2721594|NCT01085968|Secondary|Functional Dexterity Test (FDT)|"Functional Dexterity test (FDT): a motor dexterity measurement for hands. Task: Pick up and flip wooden pegs on a 4x4 pegboard in a zig-zag pattern; timed. Task is performed 2 times per hand Modified Task: Interchange 2 columns of of pegs (4 pegs each side) simultaneously. No flipping is required.~5 second penalty to time score for 1.) using the pegboard to help with flipping and 2.) supinating of the hand; per occurrence. 10 second penalty to time score for dropping a peg, per occurrence."|time of enrollment and 2 months following enrollment (before and after training)||||Seconds||Standard Deviation|Mean
2721595|NCT01085968|Secondary|Task Errors and Variability|Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials|time of enrollment and 2 months following enrollment (before and after training)||||Number of Errors||Standard Deviation|Mean
2721596|NCT01085968|Secondary|Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion|"Modified Emory Functional Ambulatory Profile (mEFAP); mobility test Task 1: 5 meter walk on hard surface; timed. Task 2: 5 meter walk on carpeted surface, timed. Task 3: Timed up and go; rise from chair, walk 3 meters, walk back, sit down in chair, timed.~Task 4: Obstacle course, similar to the Timed up and go, with 2 obstacles to be stepped over while walking forward and coming back; timed.~Task 5: Ascend and descend 5 steps of stairs; timed."|time of enrollment and 2 months following enrollment (before and after training)||||Seconds||Standard Deviation|Mean
2721597|NCT01085968|Primary|Reaction Time and Variability for Movement Task|Before and after computer training outcome measures: left, right, bimanual external cue reaction time; left, right, bimanual external cue error; left, right, bimanual internally generated reaction time; left, right, bimanual internally generated error for four-digit trials.|time of enrollment and 2 months following enrollment (before and after training)|PD Subjects: total number of subjects: 29, 8 withdrew from study, 2 had incomplete data. CO Subjects: total number of subjects: 25, 4 withdrew from study|||milliseconds||Standard Deviation|Mean
2721598|NCT01085903|Secondary|Time to Swallow Puree Food|This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).|baseline and after three days of intervention||||seconds||Standard Deviation|Mean
2721599|NCT01085903|Secondary|Power Function Exponent for Oral Bolus Estimation|This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention||||exponent||Standard Deviation|Mean
2721600|NCT01085903|Secondary|PVT Fastest 10 Percent of Reaction Times|This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention||||milliseconds||Standard Deviation|Mean
2721601|NCT01085903|Primary|P50 Percent Habituation Score|This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention||||percentage of change in amplitude||Standard Deviation|Mean
2721602|NCT01085825|Primary|Accurate Confirmation of Completed Abortion|Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses|2 weeks - 6 months||||participants|||Number
2721603|NCT01085812|Primary|Time to Relapse (Days)|Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4|24 Weeks|The double blind Intent-to-treat population consists of 342 randomized participants who received study drug and were evaluated for the Primary Outcome Measure|||Days||Standard Deviation|Mean
2721604|NCT01085786|Secondary|Compliance Rate|Good compliance is defined as taking equal or more than 90% of eradication medicines|Dec 2010|||||||
2721605|NCT01085786|Secondary|Adverse Events|by standardized questionnaire|Dec 2010|||||||
2721606|NCT01085786|Primary|Number of Participants in Which H. Pylori Was Eradicated|evaluate eradication outcome by endoscopy with urease test or urea breath test|Dec 2010||||participants||95% Confidence Interval|Number
2721607|NCT01085760|Secondary|Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment||baseline, 12 weeks|Per protocol analysis done|||mg/L||Full Range|Median
2721608|NCT01085760|Secondary|Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment|The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age [years]) + 0.54 Ln (total bilirubin [mg/dL]) + 0.54 Ln (AST [IU/L]) + 1.24 (variceal bleeding) - 0.84 (albumin [g/dL]). There is no range, minimum, or maximum value but greater values indicate worse disease.|baseline, 12 weeks|Per protocol analysis|||units on a scale||Full Range|Median
2721609|NCT01085760|Secondary|Change From Baseline in Total Bilirubin Following 12 Weeks Treatment||baseline, 12 weeks|Per protocol analysis done|||mg/dl||Full Range|Median
2721610|NCT01085760|Primary|Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment||baseline, 12 weeks|The number of participants was based on a per protocol analysis.|||U/L||Full Range|Median
2721611|NCT01085734|Secondary|Change in Macular Thickness and Macular Volume|OCT central subfield thickness measured in microns|6 months||||microns||Standard Deviation|Mean
2721612|NCT01085734|Secondary|Number of Injections Needed|number of Avastin and Ozurdex injections needed|baseline to 6 months||||injections|||Number
2721613|NCT01085734|Primary|Change From Baseline Visual Acuity at 6 Months|Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|6 months||||ETDRS score||Standard Deviation|Mean
2721614|NCT01085682|Primary|Incidence of Type 2 Diabetes Mellitus|Incidence of type 2 diabetes mellitus|one year follow up||||participants|||Number
2721615|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
2721616|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
2721617|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
2721618|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Placebo|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
2721619|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
2721620|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
2721621|NCT01085630|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.|Baseline up to 3 years||||Participants|||Count of Participants
2721622|NCT01085630|Secondary|Response Rate|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test|Up to 3 years|One patient on the observation arm did not submit any follow-up forms and withdrew consent to all follow-up and thus excluded in this analysis.|||percentage of participants||95% Confidence Interval|Number
2721623|NCT01085630|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Baseline up to 3 years||||months||95% Confidence Interval|Median
2721624|NCT01085630|Primary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Baseline up to 3 years||||months||95% Confidence Interval|Median
2721673|NCT01085214|Secondary|Incidence of Toxicity That May Be Treatment Emergent|Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).|1 year, 11 months|All participants who received study treatment|||participants|||Number
2721625|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment|The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
2721626|NCT01085591|Secondary|Median Time to Resolution of Diarrhea|The median time to resolution of diarrhea is presented for evaluable participants in each treatment group. The time in days from the start of treatment (time of first dose of study drug) to resolution (time of the last UBM on the day before the first of 2 consecutive days of < 4 UBMs and sustained through the second day following the last dose of study drug).|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug, had a confirmed diagnosis of Clostridium difficile infection (CDI), and who achieved resolution of their diarrhea.|||Days||95% Confidence Interval|Median
2721627|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. If diarrheal symptoms returned, participants were asked to indicate the number of UBM they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week FUP. Strain at Baseline=SAB.|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
2721628|NCT01085591|Secondary|Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with investigator assessed clinical response of cure, failure or unable to evaluate is presented and shown separately for participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the EOT. The information to assess clinical response for infection caused by C. difficile BI/NAP1/027 strain at Baseline was collected at any time up to and including Day 12. Strain at Baseline=SAB|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
2721629|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period|The number of participants with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. Only subjects deemed a cure at EOT were assessed for recurrence. This is the denominator used for all percentages. If diarrheal symptoms returned, participants were asked to indicate the number of unformed bowel movements (UBM) they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week Follow-up Period (FUP).|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||Participants|||Number
2721630|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment|The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
2721631|NCT01085539|Primary|Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant.|Sat Secs is an oxygen alarm with 5 settings:0,10,25,50,and 100. At each setting,using the units of seconds,it filters nusiance alarms & identifies important alarms that result in the clinicians changing the care of the infant.|4 hours|All patients with complete data|||percentage of interventions|||Number
2721632|NCT01085513|Secondary|CE-EIA Scores for Dysmotility||within 7 days|||||||
2721633|NCT01085513|Secondary|Clinical Symptoms||within 7 days|||||||
2721634|NCT01085513|Secondary|Features Detected by CE-EIA: Contractile Patterns; Non Contractile Patterns - Wall and Tunnel Patterns; Luminal Content - Turbid Pattern; Endoluminal Motion; Capsule Displacement.||within 7 days|||||||
2721635|NCT01085513|Primary|Test Characteristics (i.e., Sensitivity, Specificity, NPV, PPV) of CE-EIA, as Compared to SB Manometry Which Will be Considered as an Imperfect Gold standard14.||within 7 days|The study was terminated without achieving the needed sample size due to very low recruitment rate. therefore, no statistical analysis has been performed. T||||||
2721636|NCT01085500|Secondary|Number of Hernia Repair Subjects With Post-Operative Urinary Retention|Urinary retention is the inability to empty the bladder. This is an educational study for surgeons. The participants in the study are surgeons, and the participant flow, baseline characteristics and first two outcome measures are for the surgeons. During the part of the study reported for the third outcome measure, the first surgical procedure (TEP) after randomization, each surgeon had one subject. Therefore, this outcome measure is for the hernia patients or subjects.|at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night||||Subjects|||Number
2721674|NCT01085214|Secondary|Duration of Response|Mean duration of response in months. Estimated using the method of Kaplan-Meier.|From response to disease progression or death, assessed up to 2 years|All participants with response|||months||Full Range|Mean
2721637|NCT01085500|Secondary|Operative Performance|The trained observer and the staff supervising surgeon graded operative performance independently using a global rating scale, Global Operative Assessment of Laparoscopic Skills (GOALS) immediately after each case, (1 rating per case if bilateral repair). The GOALS tool has been shown to be a valid and reliable tool to measure generic laparoscopic skills in the simulated environment and in the operating room, with good agreement between live and video-review ratings. The scores range from 6 to 30, a higher score indicates greater operative performance.|at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two||||units on a scale||Standard Deviation|Mean
2721638|NCT01085500|Primary|Participation-Corrected Operative Time|Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time_corrected = time_raw + (1-participation) x time_raw.|at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two||||minutes||Standard Deviation|Mean
2721639|NCT01085357|Secondary|Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Month 24 postoperative|ITT|||percentage of eyes|Eyes||Number
2721640|NCT01085357|Secondary|Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|ITT|||mmHg||Standard Deviation|Mean
2721641|NCT01085357|Primary|Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|Intent-to-treat (ITT)|||percentage of eyes|Eyes||Number
2721642|NCT01085344|Secondary|Complications Arising From Indwelling Venous Catheter|collect information on any complications relating to indwelling venous catheters that some subject use.|6 months|25 participants had a central venous access device (CVAD) during the study|||Participants|||Count of Participants
2721643|NCT01085344|Secondary|Joint Damage as Determined by the Physiotherapy Score|Complete the modified Colarado Physiotherapy Assessment every 6 months at each visit with a score range 0-30 for ankles and knees and 0-26 for elbows), measured at all study visits, which we modified by not assessing crepitus or the ankle joint circumference measurement. For each scale, 0 represents no joint damage, with 26/30 representing maximum possible joint damage. The reported score represents the median end of study score|through study completion, a median of 10 years|Median CCPES Score at study-end|||units on a scale||Full Range|Median
2721644|NCT01085344|Secondary|Physical Disability as Measured by the CHAQ|"complete the Child Health Assessment Questionnaire (CHAQ) at each 6 month visit. The CHAQ is a validated tool to measure a disability index, with a possible score range of 0-3, where 0 represents no disability and 3 represents maximal disability. The CHAQ is known to have a strong ceiling effect.~The CHAQ was collected at each study visit (i.e. every 6 months for the duration each patient was on study). The reported score represents the median end of study score."|through study completion, a median of 10 years||||units on a scale||Inter-Quartile Range|Median
2721645|NCT01085344|Secondary|Number of Patients Who Developed an Inhibitor to FVIII|The number of patients who developed an inhibitor for FVIII, defined as >= 0.5 Bethesda Units|6 months||||Participants|||Count of Participants
2721646|NCT01085344|Secondary|Annualized Factor Use|annual factor usage per subject|12 months||||IU/kg/year||Inter-Quartile Range|Median
2721647|NCT01085344|Secondary|Annualized Bleeding Rate|Number of index hemarthorses (bleeds into ankles, elbows or knees) per patient per year|6 months||||episodes per participant per year||Inter-Quartile Range|Median
2721648|NCT01085344|Primary|Number of Participants Who Developed Target Joint Bleeding|The number of participants who developed target joint bleeding during the study, which was defined as 3 bleeds into any 1 joint within a period of 3 months.|6 months||||Participants|||Count of Participants
2721649|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAES between first dose of study drug administration and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, safety outcome measure could not be performed.||||||
2721650|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Best Overall Response|BOR was defined based on Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, Best overall response was not evaluated.||||||
2721651|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Circulating Biomarkers||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, circulating biomarkers were not evaluated.||||||
2721652|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Circulating Biomarkers in Serum||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Number of subjects enrolled in the safety run-in part of the trial was less and it would not provide sufficient statistical power to perform any analysis. Hence, the biomarker samples were not analyzed as part of the trial.||||||
2721653|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Best Overall Response (BOR)|BOR was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|The efficacy analysis set included all subjects who received at least 1 trial drug dose (any of the three FOLFIRI drugs and pimasertib) and had a baseline tumor assessment and at least 1 post-baseline efficacy assessment.|||Subjects|||Number
2721654|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of AUC0-inf of Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)|The AUC(0-inf) was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Ratio||Full Range|Median
2721655|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of Cmax for Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Ratio of Cmax||Full Range|Median
2721656|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Volume of Distribution (Vz f) Pimasertib, (Vz) of Irinotecan and SN-38|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Liter||Full Range|Median
2721657|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Clearance (CL/f) of Pimasertib, (CL) Irinotecan and SN-38|Clearance of a drug was a measure of the rate at which drug was metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Liter per hour||Full Range|Median
2721658|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Terminal Half Life (t1/2) of Pimasertib, Irinotecan and SN-38|The t1/2 was defined as the time required for the plasma concentration of pimasertib and irinotecan to decrease 50% in the final stage of elimination.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||hour||Full Range|Median
2721659|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib, Irinotecan and SN-38|The AUC(0-inf) of pimasertib and irinotecan was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||ng/mL*hour||Full Range|Median
2721660|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to the Time of Last Observation (AUC0-t) of Pimasertib, Irinotecan and SN-38|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."|||(nanogram/milliliter)*hour([ng/mL]*hour)||Full Range|Median
2721661|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Time to Reach Maximum Observed Concentration (Tmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."|||hour||Full Range|Median
2721662|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."|||nanogram per milliliter (ng/mL)||Full Range|Median
2721663|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).|||Subjects|||Number
2721664|NCT01085331|Primary|Part 2 or Phase 2 Randomised Part: Progression Free Survival (PFS)|PFS was defined as time (in months) from the date of randomization to the first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause.|From randomization up to first documented disease progression maximum up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, PFS was not evaluated for this study.||||||
2721665|NCT01085331|Primary|Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD)|MTD was defined as the dose level, at which the treatment-related dose limiting toxicity (DLT) occurred in >1 of 3 subjects or in >1 of 6 subjects. DLT was defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Any Grade >=3 non-hematological toxicity except for Grade 4 asymptomatic increases in liver function tests (LFTs) reversible within 7 days in subjects with liver involvement, Grade 3 asymptomatic increases in LFTs reversible within 7 days in subjects without liver involvement, Grade 3 vomiting controlled with adequate and optimal therapy and prophylaxis, and Grade 3 diarrhea controlled with adequate and optimal anti-diarrhea therapy; any Grade 4 neutropenia lasing >5 days/ febrile neutropenia lasting >1 day; any Grade 4 thrombocytopenia/Grade 3 with bleeding; any treatment delay >2 weeks due to trial treatment-related adverse effects at any dose level and judged to be possibly or probably related to the trial treatment.|Baseline up to Day 28 (Part 1)|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).|||mg|||Number
2721666|NCT01085318|Other Pre-specified|Time to First Clinical Relapse|Time to First Clinical Relapse|Months||||months||Standard Deviation|Mean
2721667|NCT01085318|Other Pre-specified|Clinical Relapses|Clinical Relapses|Over 6 months||||relapses per participant||Standard Deviation|Mean
2721668|NCT01085318|Secondary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months|To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6||||mm^3||Full Range|Median
2721669|NCT01085318|Primary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months|To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6|The analysis were run on the Intent-to-Treat (ITT) set defined as all RRMS subjects with at least one injection of Rebif and all HC who signed the informed consent form. Missing data were not imputed.|||mm^3||Full Range|Median
2721670|NCT01085214|Other Pre-specified|Level of Key Regulators|The level of key regulators of the MEK/MAPK and PI3K pathways and HSP90 and cell cycle regulators may determine the anti-tumor response to AZD6244 in vivo in multiple myeloma (MM).|Up to 20-30 hours after receiving the first dose of selumetinib|||||||
2721671|NCT01085214|Other Pre-specified|Changes in Bone Marrow Microenvironment|Effect of AZD6244 on the bone marrow microenvironment in MM.|Baseline to up to 20-30 hours after receiving the first dose of AZD6244|||||||
2721676|NCT01085201|Secondary|Pain Levels During a Vaso-occlusive Event in Children and Adults With SCD.|Pain was measured using a standardized pain scale. The scale is a 10-cm visual analogue scale (10 cm-long line printed on white paper), where 0 is no pain and 10 is maximum pain. Participants were asked to indicate their pain level by marking on the line prior to each blood draw.|pre-drug to 54 hours|The number of participants was determined per protocol following a 3+3 design. Stages 1, 2 and 2b were excluded because this outcome measure is specific to the experience of a vaso-occlusive event, which was studied in Stages 3 and 4.|||units on a scale||Standard Deviation|Median
2721677|NCT01085201|Secondary|Percentage of Activated iNKT Cells and/or Activation Markers on iNKT Cells in Individuals With SCD.|Percentage of activated iNKT cells after receiving a 24-hour infusion of Lexiscan was compared to pre-drug. iNKT cell activation was evaluated using antibodies targeting the p65 subunit of nuclear factor-kappa B (phospho-NF-kB p65). Measures are given as percentage of change in phospho-NF-kB p65 activation in iNKT cells compared to pre-drug after a 24-hour infusion. iNKT cell activation in Stages 1, 2b, and 4 was not analyzed (see analysis population description).|pre-drug to 54 hours|The number of subjects was determined per protocol. Stage 1 was excluded as the goal was to determine the optimal markers for iNKT cells. Only 4 subjects were analyzed in Stage 2 because 24-hour samples were not obtained for 2 subjects. Stages 2b and 4 were not completely analyzed because these stages were completed early after studying 3 subjects.|||percentage of change in activation||Standard Deviation|Median
2721678|NCT01085201|Primary|Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD.|"Per protocol, Lexiscan was considered safe if well tolerated based on number of DLTs reported. Stage 1 of the study was a 3+3 dose escalation study. Three doses were tested: 0.24 mcg/kg/hr (dose level 0), 0.6 mcg/kg/hr (dose level 1), and 1.44 mcg/kg/hr (dose level 2). Dose escalation continued until 6 participants were treated at the maximum planned dose (dose level 2). We studied a total of 15 patients in Stage 1. In Stages 2 and 3, if at least 2/3 participants tolerated the dose, an additional 3 participants were studied. We studied 6 participants in each of stages 2 and 3. In stage 2b, Lexiscan was studied for a longer (48 hr) duration in 3 participants. In stage 4, Lexiscan was studied in 3 pediatric participants."|30 to 54 hours plus 30-day follow-up|The number of participants was determined per protocol following a 3+3 design. In Stages 2b and 4, we received permission from the FDA, IRB, and DSMB to study only 3 subjects because we did not observe any prior DLT. One patient enrolled in Stage 2b withdrew consent during the infusion due to an unrelated toothache, and was excluded from analysis.|||number of DLT|||Number
2721679|NCT01085136|Secondary|Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.|Safety of Afatinib as indicated by intensity and incidence of adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0 both for Part A and Part B. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B)|Treated Set|||Percentage of participants|||Number
2721680|NCT01085136|Secondary|Objective Response (Part B)|Objective response (CR, PR) of Afatinib/paclitaxel combination therapy and comparator chemotherapy in Part B after progression in Part A according to RECIST 1.1 .|Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months|Randomized Set|||Percentage of participants||95% Confidence Interval|Number
2721681|NCT01085136|Secondary|Objective Response (Part A)|Objective response defined as the best overall response of complete response [CR]: disappearance of all target lesion & partial response [PR]: ≥30% decrease in the sum of the longest diameter of target lesions , taking as reference the baseline sum longest diameter of Afatinib monotherapy according to RECIST 1.1 for Part A.|Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months|Treated set|||Percentage of participants||95% Confidence Interval|Number
2721682|NCT01085136|Secondary|Overall Survival (Part B)|"Overall survival (OS) as determined by the time from randomization to death in part B.~Median was calculated from the Kaplan−Meier curve."|From randomization until death; Up to 32 months|Randomised Set|||Months||95% Confidence Interval|Median
2721683|NCT01085136|Secondary|Progression Free Survival (Part A)|"Progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A.~Median was calculated from the Kaplan−Meier curve."|From first dose administration until disease progression or death; Up to 51 months|Treated set|||Months||95% Confidence Interval|Median
2721684|NCT01085136|Primary|Progression Free Survival (Part B)|"Progression free survival (PFS) time as determined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 from day of randomization until disease progression or death for patients randomised to combination therapy with afatinib plus paclitaxel or to investigator's choice of chemotherapy.~Median was calculated from the Kaplan−Meier curve."|From randomization until disease progression or death; Up to 32 months|Randomised Set: This analysis set consist of all randomised patients irrespective of whether treated or not.|||Months||95% Confidence Interval|Median
2721685|NCT01085045|Secondary|Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
2721686|NCT01085045|Secondary|Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
2721687|NCT01085045|Secondary|Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
2721688|NCT01085045|Secondary|Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
2721689|NCT01085045|Secondary|12 hr Post-dose Trough FEV1 on Day 7|12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2721697|NCT01085045|Primary|FEV1 AUC 0-12 on Day 7|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration|"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7"|Modified Intent to Treat (MITT) Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
2721698|NCT01085006|Secondary|Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery||First 24 hours|||||||
2721699|NCT01085006|Primary|The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward||During the procedure and within 2 hours afterwards||||ml||Full Range|Median
2721700|NCT01084772|Secondary|Evaluation of Health Economic Surgical Criteria|Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics.|During and immediately following surgery||||participants|||Number
2721701|NCT01084772|Secondary|Evaluation of Health Economic Criteria - Instrument Tray Use|Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.|During and immediately following surgery|Not all analysis values were available for all enrolled subjects.|||number of trays||Standard Deviation|Mean
2721702|NCT01084772|Secondary|Evaluation of Health Economic Criteria - Incision Length|Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.|During and immediately following surgery|Not all analysis values were available for all enrolled subjects.|||mm||Standard Deviation|Mean
2721703|NCT01084772|Secondary|Evaluation of Health Economic Criteria - Blood Loss|Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.|During and immediately following surgery|Not all analysis values were available for all enrolled subjects.|||mL||Standard Deviation|Mean
2721704|NCT01084772|Secondary|Evaluation of Health Economic Criteria - Surgical Time Details|Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.|During and immediately following surgery|Not all analysis values were available for all enrolled subjects.|||minutes||Standard Deviation|Mean
2721705|NCT01084772|Secondary|Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively|X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.|2 years postoperatively|Not all subjects completed the serial radiographic evaluations at the specified time points.|||participants|||Number
2721706|NCT01084772|Secondary|Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively|X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.|2 years postoperatively|Not all subjects completed the serial radiographic evaluations at the specified time points.|||participants|||Number
2721707|NCT01084772|Secondary|Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively|X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.|1 year postoperatively|Not all subjects completed the serial radiographic evaluations at the specified time points.|||participants|||Number
2721708|NCT01084772|Secondary|Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively|X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.|1 year postoperatively|Not all subjects completed the serial radiographic evaluations at the specified time points.|||participants|||Number
2721709|NCT01084772|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively|Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all.|Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively|Not all enrolled subjects completed the KOOS questionnaire at each time point.|||score on a scale||Standard Deviation|Mean
2721710|NCT01084772|Secondary|Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray|Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.|3 months postoperative|Evaluation of Mechanical Alignment 3 Months Postoperatively was not completed for all enrolled subjects. Only data for 88 participants was available.|||Participants|||Count of Participants
2721711|NCT01084772|Primary|Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire|The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.|2 years postoperatively||||Participants|||Count of Participants
2721712|NCT01084772|Primary|Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score|The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.|2 years postoperatively|The Knee Society Clinical Score was not completed for all enrolled subjects. Data was only available for 83 subjects.|||score on a scale||Standard Deviation|Mean
2721713|NCT01084759|Secondary|Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||participants|||Number
2721714|NCT01084759|Primary|Time to PSA Progression|Time to a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart.|2 years||||days||Full Range|Median
2721715|NCT01084759|Primary|Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.||3 months||||Percentage of Participants||95% Confidence Interval|Number
2721716|NCT01084707|Primary|Average Concentration|Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)|During the last dosing interval (hour 11-12 post-dose)|ITT|||(ng/ml)||Standard Deviation|Geometric Mean
2721717|NCT01084707|Secondary|Nicotine Plasma Concentration|The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment|One hour after start of treatment|ITT|||(ng/ml)||Standard Deviation|Geometric Mean
2721718|NCT01084707|Secondary|Peak-Trough Fluctuation|Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)|During the last dosing interval (hour 11-12 post-dose)|ITT|||Percent Fluctuation||Standard Deviation|Mean
2721719|NCT01084707|Secondary|Minimum Plasma Concentration|The minimum nicotine plasma concentration during the last dosing interval (Cmin)|During the last dosing interval (hour 11-12 post-dose)|ITT|||(ng/ml)||Standard Deviation|Mean
2721720|NCT01084707|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During the last dosing interval (hour 11-12 post-dose)|ITT|||(minutes)||Full Range|Median
2721721|NCT01084707|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During the last dosing interval (hour 11-12 post-dose)||||(ng/ml)||Standard Deviation|Geometric Mean
2721722|NCT01084694|Secondary|Length of Patient Hospitalization||pretransplant to 1 year post-transplant||||days||Full Range|Mean
2721723|NCT01084694|Secondary|Common Characteristics of Caregivers|12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress|Baseline|Caregivers were analyzed|||common characteristics|||Number
2721724|NCT01084694|Secondary|Overall Patient Survival|Number of patients who are alive at 1 year|Pre-transplant to 1 year post-transplant||||Participants|||Count of Participants
2721725|NCT01084694|Secondary|Patient Distress, Fatigue & Pain Scores|BSI scale 0-72 with the higher score representing higher distress Brief Fatigue inventory 0-90 with the higher score representing higher fatigue Brief Pain inventory 0-120 with the higher score representing higher pain|Baseline, Day 30 & 1 year|This measure was assessed in patients.|||units on a scale||Full Range|Mean
2721726|NCT01084694|Primary|Brief Symptom Inventory and Burden Interview|"Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88.~Time frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year)."|Baseline, Day 30 & 1 year|74 caregivers met criteria for analysis|||units on a scale||Full Range|Mean
2721727|NCT01084668|Secondary|Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions|Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|From the time of participant consent until 70 days after last dose of study drug|Analysis was performed on the All Treated population.|||participants|||Number
2721728|NCT01084668|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).|Inclusion visit (Week 0), Week 4, Week 36, and Week 52|Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.|||units on a scale||Standard Deviation|Mean
2721729|NCT01084668|Secondary|Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.|||units on a scale||Standard Deviation|Mean
2721730|NCT01084668|Primary|Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)|PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0) to Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.|||participants|||Number
2721731|NCT01084668|Primary|Psoriasis Area and Severity Index (PASI) Score|Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.|||units on a scale||Standard Deviation|Mean
2721732|NCT01084655|Secondary|Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs)|Baseline is defined as the last scheduled observed measurement prior to the first dose of drug.|Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days)|Safety analysis set where baseline and post-baseline assessments were available. The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||milliliter (mL)||Standard Deviation|Mean
2721733|NCT01084655|Secondary|Phase 2: Percentage of Participants With Objective Measurable Disease Response|Percentage of participants with objective measurable disease response based assessment of complete response (CR), partial response (PR), stable disease or PD according to RECIST (Version 1.1). A CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to less than (<)10 millimeter (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes.|Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)|The RECIST-evaluable population was defined as all participants with measurable disease by RECIST (Version 1.1) at baseline, and with at least 1 postbaseline tumor response assessment (RECIST, Version 1.1).|||percentage of participants|||Number
2721734|NCT01084655|Secondary|Phase 2: Time to Radiographic Disease Progression|Time to Radiographic Disease Progression was defined as (date of Radiographic Disease progression) - (date of first dose of drug) + 1. Radiographic disease progression is defined as the presence of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) criteria and/or bone scan progression determined according to second Prostate Cancer Clinical Trials Working Group (PCWG2) bone scan criteria.|Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)|The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||days||95% Confidence Interval|Median
2721735|NCT01084655|Secondary|Phase 2: Time to PSA Progression|Time to PSA progression was defined as (date of PSA progression) - (date of first dose of drug) + 1, where PSA progression was defined as: For participants whose PSA concentrations never declined before the end of Cycle 4 of treatment: a) >=25% increase over the baseline level and an increase in absolute PSA concentration >=2 ng/mL; For participants who initially experienced a PSA decline: a) >=25% increase in PSA above the nadir concentration and an increase in absolute PSA concentration >=2 ng/mL.|Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)|The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||days||95% Confidence Interval|Median
2721736|NCT01084655|Primary|Phase 2: Best PSA Response|Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1.|Cycle 2 Day 1 up to Cycle 12 Day 21|The PSA-evaluable population included all participants with a baseline PSA evaluation and at least 1 PSA evaluation beyond Cycle 1, or participants with baseline PSA evaluation without a beyond-cycle-1 PSA evaluation due to PSA progression, disease progression, unacceptable AE, or death.|||percent change||Standard Deviation|Mean
2721737|NCT01084655|Primary|Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90%|PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration.|Cycle 4 Day 21|The PSA-evaluable population included all participants with a baseline PSA evaluation and at least 1 PSA evaluation beyond Cycle 1, or participants with baseline PSA evaluation without a beyond-cycle-1 PSA evaluation due to PSA progression, disease progression, unacceptable adverse event (AE), or death.|||percentage of participants||80% Confidence Interval|Number
2721738|NCT01084655|Primary|Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel||Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel|The PK-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2721739|NCT01084655|Primary|Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel||Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel|PK set where Cmax,ss data was available. The PK-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721740|NCT01084655|Primary|Phase 2: Terminal Phase Elimination Half-life (T1/2) for Docetaxel||Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion|Data was not calculated since no participant was available for analysis.||||||
2721741|NCT01084655|Primary|Phase 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Docetaxel||Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion|Data was not calculated since no participant was available for analysis.||||||
2721742|NCT01084655|Primary|Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel||Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion|The PK-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2721743|NCT01084655|Primary|Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel||Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion|The pharmacokinetic (PK)-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2721744|NCT01084655|Primary|Number of Participants With TEAEs Related to Electrocardiogram (ECG)||Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||participants|||Number
2721745|NCT01084655|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||participants|||Number
2721746|NCT01084655|Primary|Number of Participants With TEAEs Related to Hematology and Serum Chemistry||Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||participants|||Number
2721747|NCT01084655|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)||Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.|||participants|||Number
2721748|NCT01084603|Primary|Bioavailability|A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).|12 hours||||h*ng/ml||Standard Deviation|Geometric Mean
2721749|NCT01084603|Secondary|Released Nicotine|The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing|After 30 minutes' chewing|ITT|||(ng/ml)||Standard Deviation|Mean
2721750|NCT01084603|Secondary|Terminal Elimination Rate Constant|The terminal nicotine elimination rate constant (Lamda z)|During 12 hours after start of administration|ITT|||(1/hr)||Standard Deviation|Mean
2721751|NCT01084603|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During 12 hours after start of administration|ITT|||(hours)||Full Range|Median
2721752|NCT01084603|Secondary|Nicotine Plasma Concentration|Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)|During 10 minutes after start of administration|ITT|||(h*ng/ml)||Standard Deviation|Geometric Mean
2721753|NCT01084603|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During 12 hours after start of administration|ITT|||(ng/ml)||Standard Deviation|Geometric Mean
2721754|NCT01084551|Secondary|Average Sleep Time in a Week|Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF|||Hours||Standard Deviation|Mean
2721755|NCT01084551|Secondary|Nocturnal Awakenings Due to RLS Symptoms in a Week|Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of days/week with awakening||Standard Deviation|Mean
2721756|NCT01084551|Secondary|Average Duration of RLS Symptoms in the Evening and Night in a Week|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF|||Hours||Standard Deviation|Mean
2721757|NCT01084551|Secondary|Incidence of RLS Symptoms in the Evening and Night|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of days/week with symptoms||Standard Deviation|Mean
2721758|NCT01084551|Secondary|Average Duration of RLS Symptoms|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF|||Hours||Standard Deviation|Mean
2721759|NCT01084551|Secondary|Incidence of RLS Symptoms|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week* 100%|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of days with RLS symptom||Standard Deviation|Mean
2721908|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 8|Per protocol population|||participants|||Number
2721760|NCT01084551|Secondary|Each Item of IRLS (10 Items)|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of participants|||Number
2721761|NCT01084551|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"Change of PSQI from baseline to the end of dose-titration/dose-maintenance period.~PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates no difficulty and 21 indicates severe difficulty. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2721762|NCT01084551|Secondary|Patient Global Impression (PGI) Improvement|"PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||Percentage of Participants|||Number
2721763|NCT01084551|Secondary|Clinical Global Impression (CGI) Improvement|"CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||Percentage of Participants|||Number
2721764|NCT01084551|Primary|International Restless Legs Syndrome Rating Scale (IRLS) Total Score|"Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2721765|NCT01084538|Secondary|Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.|Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.|Baseline through 12 months|Analysis was based on the number of subjects included in the full analysis set (N=175).|||participants|||Number
2721766|NCT01084538|Secondary|Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL|The average time (measured in days) to achieve target iPTH levels.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.|||Days||Standard Deviation|Mean
2721767|NCT01084538|Secondary|Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)|Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.|||percentage of participants|||Number
2721768|NCT01084538|Primary|Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline||Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.|||percentage of participants|||Number
2721769|NCT01084499|Primary|Letrozole : Cmax|Maximum Measured Concentration of Letrozole in Plasma|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration||||ng/mL||Standard Deviation|Mean
2721770|NCT01084499|Primary|Letrozole : AUC0-tz|Area Under the Concentration-time Curve of Letrozole in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration||||ng•hr/mL||Standard Deviation|Mean
2721771|NCT01084278|Primary|Percentage of Colchicine Dose Recovered in Dialysate|The cumulative percentage of the colchicine dose recovered in dialysate.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.|||percent dose||Standard Deviation|Mean
2721772|NCT01084278|Primary|Dialysis Clearance of Colchicine (CLD)|The dialysis clearance of colchicine, calculated as amount of colchicine recovered in dialysate / AUCt2-t1 where t1 and t2 are the times of the start and end of hemodialysis.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.|||L/h||Standard Deviation|Mean
2721773|NCT01084278|Primary|Renal Clearance of Colchicine (CLR)|Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t.|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/hr||Standard Deviation|Mean
2721774|NCT01084278|Primary|Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time|The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||percent of dose||Standard Deviation|Mean
2721785|NCT01084278|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||ng/mL||Standard Deviation|Mean
2721775|NCT01084278|Primary|Amount of Colchicine Excreted in Urine (Ae[0-t])|The amount of colchicine excreted in urine during the post-dose collection, calculated as the sum of the amounts in the individual collection intervals (Ae).|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||mg||Standard Deviation|Mean
2721776|NCT01084278|Primary|Weight-adjusted Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/hr/kg||Standard Deviation|Mean
2721777|NCT01084278|Primary|Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/hr||Standard Deviation|Mean
2721778|NCT01084278|Primary|Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/kg||Standard Deviation|Mean
2721779|NCT01084278|Primary|The Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L||Standard Deviation|Mean
2721780|NCT01084278|Primary|Apparent First-order Terminal Elimination Half-life (t½)|The apparent first-order terminal elimination half-life was calculated as 0.693/Kel.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||hr||Standard Deviation|Mean
2721781|NCT01084278|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel)|Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve for colchicine. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||1/hr||Standard Deviation|Mean
2721782|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)|The area under the plasma concentration versus time curve extrapolated to infinity. AUC 0 - ∞ is calculated as the sum of total AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||ng*h/mL||Standard Deviation|Mean
2721783|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration, calculated by the linear trapezoidal method.|Day 1 and Day 15 (ESRD patients only), predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||ng*h/mL||Standard Deviation|Mean
2721784|NCT01084278|Primary|Time to Maximum Plasma Concentration (Tmax)|The time to reach the maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||hours||Standard Deviation|Mean
2721786|NCT01084265|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Day 14|Safety analysis set included all participants who received investigational drug for at least one time.|||participants|||Number
2721787|NCT01084265|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
2721788|NCT01084265|Secondary|Average Change of E2 Level in Participants Per Day up to Day 14|The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 [hCG administration day]).|up to Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||pg/mL per day||Standard Deviation|Mean
2721789|NCT01084265|Secondary|Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||follicles||Standard Deviation|Mean
2721790|NCT01084265|Secondary|Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||follicles||Standard Deviation|Mean
2721791|NCT01084265|Primary|Number of Participants Who Refused to Take hCG Injection|Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
2721792|NCT01084265|Primary|Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
2721793|NCT01084265|Primary|Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
2721794|NCT01084265|Primary|Number of Participants Who Met Both Index 1 and Index 2|The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
2721795|NCT01084252|Secondary|Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab|ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 2 Stage 2) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.|Up to 97 weeks|Analysis was performed on ADA evaluable population which included all treated participants with at least one ADA assessment with a reportable result during the ADA on-study observation period.|||Participants|||Count of Participants
2721796|NCT01084252|Secondary|Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough|Ctrough is the plasma concentration observed before treatment administration. For 1st category, the accumulation ratio was calculated by dividing Ctrough value of Cycle 2 Day 1 by Cycle 1 Day 8 and for second category, accumulation ratio was calculated by dividing Ctrough value of Cycle 4 Day 1 by Cycle 1 Day 8.|Cycle 2, Day 1; Cycle 1, Day 8; Cycle 4, Day 1|Analysis was performed on PK population. Here, ‘number of participants analyzed’ = participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2721797|NCT01084252|Secondary|Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)||At Day 1, 8, and 22|Analysis was performed on PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2721798|NCT01084252|Secondary|Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 4 Weeks Interval||Cycle 1, Day 1: pre-dose, at the end of infusion, 168, 336, and 672 hours post-infusion|Analysis was performed on PK population.|||mcg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2721799|NCT01084252|Secondary|Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 2 Weeks Interval||Cycle 1, Day 1: pre-dose, at the end of infusion, 168 and 336 hours post-infusion|Analysis was performed on PK population.|||mcg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2721800|NCT01084252|Secondary|Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 1 Week Interval||Pre-dose, at the end of infusion, 1 hour and 168 hours post dose on Day 1 of Cycle 1|Analysis was performed on PK population which included participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.|||mcg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2721909|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 4|Per Protocol Population|||participants|||Number
2721801|NCT01084252|Secondary|Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|"Analysis was performed on AT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category."|||score on a scale||Standard Deviation|Mean
2721802|NCT01084252|Secondary|Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with MM. It has 4 subscales: body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). Disease symptoms subscale used 4-point scale ranged from 1= 'Not at All' to 4= 'Very Much'. Scores were averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL.|Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|"Analysis was performed on AT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category."|||score on a scale||Standard Deviation|Mean
2721803|NCT01084252|Secondary|Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) & other single items. For each item, high score = high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and End of Treatment (EOT: anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|"Analysis was performed on AT population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category."|||score on a scale||Standard Deviation|Mean
2721804|NCT01084252|Secondary|Phase 2 Stage 2: Overall Survival|OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.|From the date of randomization to date of death from any cause (maximum duration: 97 weeks)|Analysis was performed on AT population.|||months||95% Confidence Interval|Median
2721805|NCT01084252|Secondary|Phase 2 Stage 1: Overall Survival (OS)|OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.|From the date of randomization to date of death from any cause (maximum duration 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|Analysis was performed on AT population.|||months||95% Confidence Interval|Median
2721806|NCT01084252|Secondary|Phase 2 Stage 2: Progression Free Survival|PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression or the date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of >25% from lowest response value in any one of the following: Serum M-component (the absolute increase must be >0.5 g/dL)4 and/or Urine M-component (the absolute increase must be >200 mg/24 h) and/or >10 mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, ≥10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.|From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 97 weeks)|Analysis was performed on AT population.|||months||95% Confidence Interval|Median
2721807|NCT01084252|Secondary|Phase 2 Stage 1: Progression Free Survival (PFS)|PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression (PD) or date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h), > 10mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, >10% absolute percentage of bone marrow plasma cell, definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.|From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|Analysis was performed on AT population.|||months||95% Confidence Interval|Median
2721829|NCT01084252|Primary|Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.|From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )|Analysis was performed on AT population which included participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.|||Participants|||Count of Participants
2721808|NCT01084252|Secondary|Phase 2 Stage 2: Percentage of Participants With Clinical Benefit|Clinical benefit:participants with sCR, CR, VGPR, PR or MR, per IMWG criteria, determined by IAC. CR:negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates,normal FLC ratio(0.26-1.65) in participants with only FLC disease.sCR:CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy.VGPR:serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24h/,>=90% decrease in difference between involved and uninvolved FLC levels; PR:>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90%/<200mg/24h,>50% decrease in difference between involved and uninvolved FLC in place of M-protein criteria, >=50% reduction in size/number of soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein,reduction in 24h urine M-protein by 50-89%, 25-49% reduction in size of soft tissue plasmacytomas|From the date of randomization to the date of first documentation of progression or death (maximum duration: 97 weeks )|Analysis was performed on AT population.|||percentage of participants|||Number
2721809|NCT01084252|Secondary|Phase 2 Stage 1: Percentage of Participants With Clinical Benefit|Clinical benefit: participants with sCR, CR, VGPR, PR or MR as per IMWG criteria, determined by IAC. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% PCs in bone marrow aspirates. sCR: CR + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours, ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline, ≥50% size reduction in soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein, reduction in 24h urine M-protein by 50-89%, 25-49% size reduction in soft tissue plasmacytomas.|From Baseline up to 30 days after the last dose (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|Analysis was performed on AT population.|||percentage of participants|||Number
2721810|NCT01084252|Secondary|Phase 2 Stage 2: Duration of Response|DOR: Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of 1st IAC determined PD or death, whichever happened earlier. As per updated IMWG criteria-PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. ≥50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline ≥50% reduction in size of soft tissue plasmacytomas; PD: Increase of >25% from lowest response value in any one of following: Serum M-component (absolute increase must be >0.5 g/dL)4 and/or Urine M-component (absolute increase must be >200 mg/24 h) and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell proliferative disorder.|From the date of first response until disease progression or death or data cut-off (maximum duration: 97 weeks)|Analysis was performed only on subset of population who had response in Phase 2 stage 2.|||months||Standard Deviation|Mean
2721811|NCT01084252|Secondary|Phase 2 Stage 1: Duration of Response|DOR:Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of first IAC determined PD/death, whichever happened earlier. updated IMWG criteria- PR:>=50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a >=50% reduction in size of soft tissue plasmacytomas; PD: Increase of 25% from lowest response value in any of following: Serum M-protein >=0.5 g/dL absolute increase and/or urine M-protein >=200 mg/24 hours absolute increase and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cells (PCs), development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium >11·5 mg/dl) attributed to PC proliferation disorder.|From the date of first response until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|Analysis was performed only on subset of population who had response in Phase 2 stage 1.|||months||Standard Deviation|Mean
2721812|NCT01084252|Secondary|Phase 2 Stage 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.|From Baseline up to 30 days after the last dose (maximum duration: 97 weeks)|Analysis was performed on AT population which included participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.|||Participants|||Count of Participants
2721813|NCT01084252|Secondary|Phase 2 Stage 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.|From Baseline up to 30 days after the last dose (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)|Analysis was performed on AT population which included Participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.|||Participants|||Count of Participants
2721821|NCT01084252|Secondary|PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First 2 Weeks (0-336 Hours) (AUC2W)|Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).|For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 336 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 336 hr post-infusion|"Analysis was performed on PK population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||mcg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2721814|NCT01084252|Secondary|Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment|ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting>50% of waking hours; 4=Bedridden or unable to care for self, where higher score indicated worst performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the worst values (categorized as: Baseline ECOG 0, During Treatment ECOG 1; Baseline ECOG 2, During Treatment ECOG 1; Baseline ECOG 0, During Treatment ECOG 2; Baseline ECOG 1, During Treatment ECOG 2; Baseline ECOG 0, During Treatment ECOG 3; Baseline ECOG 1, During Treatment ECOG 3; Baseline ECOG 2, During Treatment ECOG 3) are reported.|At baseline, during treatment (up to 120 weeks)|Analysis was performed on AT population. Data for this outcome measure was planned to be collected and analyzed for a combined arm of overall Phase 1 AT population.|||Participants|||Count of Participants
2721815|NCT01084252|Secondary|Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment|ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting >50% of waking hours; 4=Bedridden or unable to care for self, where lower score indicated good performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the best values (categorized as: Baseline ECOG 1, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 1) are reported.|At baseline, during treatment (Day 1 up to 120 weeks)|Analysis was performed on AT population. Data for this outcome measure was planned to be collected and analyzed for a combined arm of overall Phase 1 AT population.|||Participants|||Count of Participants
2721816|NCT01084252|Secondary|Clinical Assessment: Phase 1: Time to First Response (TTR)|TTR was defined as the time from first dose of isatuximab to first response (PR or better). PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.|From the date of first dose administration to the date of first response or death (due to any cause) (maximum duration: 120 weeks)|Analysis was performed only on subset of participants who had response in Phase 1 and not for the reporting group with no response.|||months||Standard Deviation|Mean
2721817|NCT01084252|Secondary|Clinical Assessment: Phase 1: Duration of Response (DOR)|DOR: time from first response (PR or better) to first documented tumor progression/death. Progression as per EBMT: >25% increase in serum monoclonal paraprotein level, which must also be an absolute increase of >= 5 g/l: confirmed by >=1 repeated investigation; >25% increase in 24h urinary light chain excretion, which must also be an absolute increase of >=200 mg/24 h:confirmed by >=1 repeated investigation; >25% increase in plasma cells in a bone marrow aspirate/on trephine biopsy, which must also be an absolute increase of >= 10%; definite increase in size of existing bone lesions/soft tissue plasmacytomas; development of new bone lesions/soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11·5 mg/dl or 2·8 mmol/l) not attributable to any other cause. PR: >=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size/number of lytic bone lesions.|From the date of first response to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)|Analysis was performed only on subset of participants who had response in Phase 1 and not for the reporting group with no response.|||months||Standard Deviation|Mean
2721818|NCT01084252|Secondary|Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria|OR defined as participants with complete response (CR) or partial response (PR) as best overall response (BOR). Clinical benefit: participants with minimal response (MR) or better as BOR. BOR: best sequential response from start of treatment through the entire study excluding any time point following start of other treatment. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, no increase in size or number of lytic bone lesions. PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. MR: 25 to 49% reduction in serum M-protein, 50-89% reduction in 24h urine M-protein, 25-49% reduction in size of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.|From the date of randomization to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)|Analysis was performed on all-treated population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.|||percentage of participants|||Number
2721819|NCT01084252|Secondary|Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response|ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 1) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.|Up to 120 weeks|Analysis was performed on ADA evaluable population which included all treated participants with at least one ADA assessment with a reportable result during the ADA on-study observation period.|||Participants|||Count of Participants
2721820|NCT01084252|Secondary|Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers|Serum/plasma markers included: tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1-β), interleukin 6 (IL-6) and interferon-gamma (IFN-Gamma). Due to change in planned analysis, data for high-sensitivity C-reactive protein (hs-CRP) and CD38 was not collected and analyzed.|Cycle 1 Day 1|Analysis was performed on all randomized participants who gave their informed consent, had received at least 1 dose (even incomplete) of isatuximab and had an assessable PD parameter. Here, ‘number analyzed’ = number of participants with available data for each category.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2721822|NCT01084252|Secondary|PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W)|Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).|For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion|"Analysis was performed on PK population. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||mcg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2721823|NCT01084252|Secondary|PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3|Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).|Week 1, 2 and 3|Analysis was performed on PK population. Here, ‘number analyzed’ = number of participants with available data for each category.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2721824|NCT01084252|Secondary|PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab|Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population.|For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion|"Here, Overall Number of Participants Analyzed=participants evaluable for this outcome measure and “0” in “number analyzed” field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms “Phase 1: Isatuximab 10mg/kg QW” and “Phase 1: Isatuximab 20mg/kg QW” was planned to be collected and analyzed."|||hours||Full Range|Median
2721825|NCT01084252|Secondary|PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab|Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population.|For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion|"Here, Overall Number of Participants Analyzed=participants evaluable for this outcome measure and “0” in “number analyzed” field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms “Phase 1: Isatuximab 10mg/kg QW” and “Phase 1: Isatuximab 20mg/kg QW” was planned to be collected and analyzed."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2721826|NCT01084252|Secondary|Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)|Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.|Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion|"Here, Overall Number of Participants Analyzed=participants evaluable for this outcome measure and “0” in “number analyzed” field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms “Phase 1: Isatuximab 10mg/kg QW” and “Phase 1: Isatuximab 20mg/kg QW” was planned to be collected and analyzed."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2721827|NCT01084252|Primary|Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria|OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours, >90% decrease in the difference between involved and uninvolved FLC levels; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or >=50% reduction in plasma cells in place of M-protein if present at baseline.|From the date of randomization to date of death from any cause (maximum duration: 97 weeks)|Analysis was performed on AT population which included participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.|||percentage of participants|||Number
2721828|NCT01084252|Primary|Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria|OR defined as participants with stringent complete response (sCR) or complete response (CR) or very good partial response (VGPR) or partial response (PR) . Based on IMWG, CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if present at baseline.|From the date of randomization until disease progression or death or data cut-off (maximum duration: 77 weeks )|Analysis was performed on AT population which included participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.|||percentage of participants|||Number
2721910|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|week 8|Per Protocol Population|||participants|||Number
2721830|NCT01084252|Primary|Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT.|Day 1 of Cycle 1 up to Day 14 of Cycle 2|DLT evaluable population included participants who gave their informed consent, received at least 1 dose of isatuximab during Phase 1 and had a DLT assessment at the end of Cycle 2. Data was planned not to be collected and analyzed for the arm: Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma).|||Participants|||Count of Participants
2721831|NCT01084239|Secondary|Rate of ED Discharge|Direct discharge from Emergency Department|Duration of stay in the hospital during the initial visit||||participants|||Number
2721832|NCT01084239|Secondary|Cost-effectiveness|Total cost during index hospitalization|Duration of stay in the hospital during the initial visit||||US Dollars||Standard Deviation|Mean
2721833|NCT01084239|Secondary|MACE|Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.|72 hours after discharge up to 28 days after enrollment.||||events|||Number
2721834|NCT01084239|Secondary|Healthcare Utilization|Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)|Duration of stay in the hospital during the initial visit||||participants|||Number
2721835|NCT01084239|Secondary|Time to Diagnosis||Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ).||||hours||Standard Deviation|Mean
2721836|NCT01084239|Primary|Length of Hospital Stay||Duration of stay in the hospital during the initial visit||||hours||Standard Deviation|Mean
2721837|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to 12 Months|IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months|Baseline and 12 months||||kUa/L||Full Range|Median
2721838|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to 6 Months|Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months|Baseline and 6 months||||kUa/L||Full Range|Median
2721839|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)||Baseline to end of dose build-up (up to 16 weeks)||||kUa/L||Full Range|Mean
2721840|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to 12 Months|IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months|Baseline and 12 months|One participant in the Active SLIT/Placebo OIT arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 12.|||mga/L||Full Range|Median
2721841|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to 6 Months|IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months|Baseline and 6 months|One participant in the Active sublingual immunotherapy (SLIT)/Placebo oral immunotherapy (OIT) arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 6.|||mga/L||Full Range|Median
2721842|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)|Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)|Baseline and end of dose build-up (up to 16 weeks)||||mga/L||Full Range|Median
2721843|NCT01084174|Primary|Number of Participants With Induced Peanut Desensitization at 12 Months|Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.|12 months||||Participants|||Count of Participants
2721844|NCT01084148|Secondary|Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B|"At the end of treatment (day 133), patients assessed their overall agreement on the local tolerance of the test product, using a 4-point scale, as follows :~= very satisfactory~= satisfactory~= poorly satisfactory~= not satisfactory at all"|133 days||||participants|||Number
2721845|NCT01084148|Primary|Treatment Response of Xerosis|"Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale:~0 = smooth skin~= patches of fine, powdery scales~= diffuse ashy appearance with many fine scales~= moderate scaling with beginning cracks~= intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I)."|28 days|One patient in V0034 CR 01B Vehicle arm randomized but not treated|||participants|||Number
2721846|NCT01084135|Secondary|Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)|The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting. It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales. Raw scores range from 63 to 189. Higher scores suggest that an individual's executive function skills are more problematic. In this study, the change between each subject's raw score at Baseline and the Final Visit was computed for the Global Executive Composite. A decline in raw scores from Baseline to the Final Visit indicates improvement.|Baseline and Final (Week 20) visit|All subjects who completed the 20 week period were included in analysis except for 1 subjects whose form was completed incorrectly.|||units on a scale||Standard Deviation|Mean
2721862|NCT01084005|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 24|FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2721847|NCT01084135|Primary|Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)|The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject's ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.|Baseline & Study termination (Week 20)|All subjects who completed the 20 week period were included in analysis except for 2 subjects whose form was completed incorrectly.|||units on a scale||Standard Deviation|Mean
2721848|NCT01084083|Secondary|Primary Clinical Response Rate|Primary clinical response rate is defined as the proportion of patients with complete response or partial response at their primary sites after induction therapy. Response status for the primary site was classified by clinical examination using endoscopy. If, however, the clinical response status of the primary was unclear based on endoscopy, then the CT or MRI (required at the end of induction) was used to determine status of the primary. If clinical and radiological evaluation of the primary was unclear, a biopsy was considered at the discretion of the treating physician.|assessed within 14 days after delivery of the third cycle of induction therapy|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2721849|NCT01084083|Secondary|24-months Overall Survival|OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2721850|NCT01084083|Primary|24-month Progression-free Survival|24-month progression-free survival is defined as the proportion of patients who were alive and progression-free at 24 months post registration. The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites|||percentage of participants||95% Confidence Interval|Number
2721851|NCT01084005|Secondary|Number of Patients With Rescue Therapy|The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial|week 24|FAS (OC)|||Number of patients|||Number
2721852|NCT01084005|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24|The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|FAS (NCF)|||percentage of patients|||Number
2721853|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|FAS (NCF)|||percentage of patients|||Number
2721854|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF)|||percentage of patients|||Number
2721855|NCT01084005|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 18|FAS (OC)|||mg/dL||Standard Error|Mean
2721856|NCT01084005|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|FAS (OC)|||mg/dL||Standard Error|Mean
2721857|NCT01084005|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 6|FAS Observed cases (OC)|||mg/dL||Standard Error|Mean
2721858|NCT01084005|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin.|Baseline and week 24|FAS (LOCF)|||mg/dL||Standard Error|Mean
2721859|NCT01084005|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 18|FAS (LOCF)|||Percent||Standard Error|Mean
2721860|NCT01084005|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 12|FAS (LOCF)|||Percent||Standard Error|Mean
2721861|NCT01084005|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 6|FAS (LOCF)|||Percent||Standard Error|Mean
2721863|NCT01083979|Secondary|Bladder Appearance|The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.|Baseline to 12 Weeks||||Ulcers|||Number
2721864|NCT01083979|Primary|Change in Symptom and Problem Severity|The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem|Baseline to 12 weeks||||units on a scale|||Number
2721865|NCT01083901|Secondary|Change in Lower Body Strength|Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.|16 weeks||||lbs||Standard Error|Mean
2721866|NCT01083901|Secondary|Changes in Upper Body Strength.|Strength was measured using the one-repetition maximum method. Upper body strength was a composite of bench press, overhead press, seated row, and lateral pull-down strength.|16 weeks||||lbs||Standard Error|Mean
2721867|NCT01083901|Secondary|Change in Total Body Fat Mass|Change from baseline to 16 weeks in total body fat mass.|16 weeks||||kg||Standard Error|Mean
2721868|NCT01083901|Primary|Change in Total Body Fat-free Mass|change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)|16 weeks|All participants with baseline and 16 week data were included in the analysis (i.e., intention-to-treat).|||kg||Standard Error|Mean
2721869|NCT01083849|Secondary|Mean Calcium-Phosphate Product Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||mmol²/l²||Standard Deviation|Mean
2721870|NCT01083849|Secondary|Mean Intact Parathormone (iPTH) Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||pmol/L||Standard Deviation|Mean
2721871|NCT01083849|Primary|Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 months|Participants with a determined chronic kidney disease (CKD) stage|||days||Standard Deviation|Mean
2721872|NCT01083849|Secondary|Mean Duration of Disability by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||days||Standard Deviation|Mean
2721873|NCT01083849|Secondary|Mean Duration of Hospitalization by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||days||Standard Deviation|Mean
2721874|NCT01083849|Secondary|Number of Participants With Elevated Calcium-Phosphorus Product|Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||participants|||Number
2721875|NCT01083849|Secondary|Number of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||participants|||Number
2721876|NCT01083849|Secondary|Number of Participants With Hypercalcemia|Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||participants|||Number
2721877|NCT01083849|Primary|Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 Months|Participants with a determined chronic kidney disease (CKD) stage|||percentage of participants|||Number
2721878|NCT01083810|Secondary|Change in Absolute CD4 Cell Count [CD4+ Cells/µL]|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with CD4+ measurements at Baseline and any subsequent time point are included.|||CD4+ cells/µL||Standard Deviation|Mean
2721911|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 4||||ng/L||Standard Deviation|Mean
2721879|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA >500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
2721880|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
2721881|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
2721882|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA <50 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
2721883|NCT01083810|Primary|Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs|Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.|Baseline and at any timepoint where testing is possible|All participants with resistance testing at baseline and follow-up are presented.|||Participants|||Number
2721884|NCT01083771|Secondary|To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet|Post diet waist circumference|8 weeks||||centimeters||Standard Deviation|Mean
2721885|NCT01083771|Primary|Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet|Based on overall percentage change at baseline versus post diet|eight weeks||||percentage of change||Standard Deviation|Mean
2721886|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment||||% of participants w/ controlled disease|||Number
2721887|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 8||||% of participants w/ controlled disease|||Number
2721888|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 4||||% of participants w/ controlled disease|||Number
2721889|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|week 2||||% of participants w/ controlled disease|||Number
2721890|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and end of treatment (up to 8 weeks)||||Percentage change||Standard Deviation|Mean
2721958|NCT01083628|Secondary|Duration of Therapy Attended|Number of weeks until patients dropped out of therapy|16 weeks|For the duration of therapy analyses, 3 patients (1 in the intervention and 2 in the control) were excluded, because the study ended before these patients had been offered 16 sessions of psychotherapy.|||weeks||Full Range|Median
2721891|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8||||Percentage change||Standard Deviation|Mean
2721892|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 4||||percentage change||Standard Deviation|Mean
2721893|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|week 2||||Percentage change||Standard Deviation|Mean
2721894|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|End of treatment||||percentage of participants|||Number
2721895|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 8||||percentage of participants|||Number
2721896|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 4||||percentage of participants|||Number
2721897|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|week 2||||percentage of participants|||Number
2721898|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 8||||ng/L||Standard Deviation|Mean
2721899|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and end of treatment (up to 8 weeks)||||mmol/g||Standard Deviation|Mean
2721900|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 8||||mmol/g||Standard Deviation|Mean
2721901|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 4||||mmol/g||Standard Deviation|Mean
2721902|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)||||mmol/24h||Standard Deviation|Mean
2721903|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8||||mmol/24h||Standard Deviation|Mean
2721904|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4||||mmol/24h||Standard Deviation|Mean
2721905|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)||||mmol/L||Standard Deviation|Mean
2721906|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8||||mmol/L||Standard Deviation|Mean
2721907|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4||||mmol/L||Standard Deviation|Mean
2721959|NCT01083628|Secondary|Attendance|Number of sessions attended|16 weeks|For the attendance analyses, 3 patients (1 in the intervention and 2 in the control) were excluded, because the study ended before these patients had been offered 16 sessions of psychotherapy.|||sessions||Standard Deviation|Median
2721912|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|Week 4|Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)|||participants|||Number
2721913|NCT01083758|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8 weeks||||percentage of participants|||Number
2721914|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set|||Percentage of participants|||Number
2721915|NCT01083732|Secondary|Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination|"Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.~Clinically Relevant Abnormalities for Laboratory Parameters were reported."|During the treatment period, Up to 6 days|Treated set|||Percentage of participants|||Number
2721916|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication- Taste Assessment|The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.|Day 1 (immediately after dosing)|Treated set|||Percentage of participants|||Number
2721917|NCT01083732|Secondary|Percentage of Patients With Any Adverse Events During the Treatment Period|Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set|||Percentage of participants|||Number
2721918|NCT01083732|Primary|Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.|Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient's underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set|||Percentage of participants|||Number
2721919|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2721920|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||hours||Full Range|Median
2721921|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)|Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721922|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2721923|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||hours||Full Range|Median
2721924|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)|Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721925|NCT01083732|Primary|Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)|||seconds||Standard Deviation|Mean
2721926|NCT01083732|Primary|Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)|||seconds||Standard Deviation|Mean
2721927|NCT01083732|Primary|Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.|at predose and 2 and 10 h after intake of study medication.|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||seconds||Standard Deviation|Mean
2721928|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 1087 SE|Plasma concentration of metabolite BIBR 1087 SE|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721929|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 951 BS|Plasma concentration of metabolite BIBR 951 BS|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721930|NCT01083732|Primary|Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)|"Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).~Some values are NA because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721931|NCT01083732|Primary|Plasma Concentration of Free Dabigatran (BIBR 953 ZW).|Plasma concentration of free dabigatran (BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721932|NCT01083732|Primary|Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)|Plasma concentration of total dabigatran (SUM BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|"Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.~PKS (evaluable cases)"|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2721933|NCT01083706|Secondary|Incidence of Grades II-IV Graft-versus-host Disease (GVHD)||6 months||||Participants|||Count of Participants
2721934|NCT01083706|Secondary|Rate of Response by IWG Criteria|Count of participants achieving a complete or partial remission at 6 months.|6 months||||Participants|||Count of Participants
2721935|NCT01083706|Primary|Overall Survival|Count of surviving participants at 6 months.|6 months||||Participants|||Count of Participants
2721936|NCT01083693|Secondary|C-Reactive Protein|The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2721937|NCT01083693|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2721938|NCT01083693|Secondary|Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
2721939|NCT01083693|Secondary|Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
2721940|NCT01083693|Secondary|Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness|Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]).|||Units on a scale||Standard Deviation|Mean
2721941|NCT01083693|Secondary|DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale|The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).|Baseline,months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
2721942|NCT01083693|Primary|EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression|"European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).~In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status."|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
2721943|NCT01083693|Primary|SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain|Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [participants who discontinued the study early]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.|||Units on a scale||Standard Deviation|Mean
2721944|NCT01083693|Primary|RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
2721945|NCT01083680|Secondary|Compliance With the Self-injection Via the Humira®-PEN|Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Compliance data were not collected.||||||
2721998|NCT01083199|Primary|Successful Device Placement|Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.|During Radical Prostatectomy||||participants|||Number
2721946|NCT01083680|Secondary|4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time|The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores < 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||units on a scale||Standard Deviation|Mean
2721947|NCT01083680|Primary|Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)|"An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.~For more details on adverse events please see the AE section below."|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Analysis included safety analysis population with incidence of greater than 1% during the study.|||percentage of participants|||Number
2721948|NCT01083680|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants|The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.|Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||units on a scale||Standard Deviation|Mean
2721949|NCT01083680|Primary|Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time|The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||percentage of participants|||Number
2721950|NCT01083680|Primary|Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit|The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.|Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||units on a scale||Standard Deviation|Mean
2721951|NCT01083667|Secondary|Appel ALS Score|an objective and timed measurement of strength and function of subjects including muscle testing, respiratory function and fine motor function, all summed together for a total value, and is measured at baseline, visit 2, visit 6 and end of study. The scale ranges from 30 in a healthy person to to 164 in a maximally impaired person; an increase in score indicates progression and is expected in disease progression.|Week 0, 6, 18, and end of study|22 subjects completed to visit 9 and had a final score for Appel Score. Reported is the mean change from Baseline to week 36|||units on a scale||95% Confidence Interval|Number
2721952|NCT01083667|Primary|Mean Change in SOD1 CSF|Reported change in mean SOD1 CSf from baseline to visit 6 (week 18) and end of study for all subjects who completed the measure|baseline, Visit 6 week 18, end of study|24 subjects completed up to visit 6 and 21 subjects for final study visit. Reported is the change in SOD1 CSF from baseline to week 36.|||ng/ml||95% Confidence Interval|Mean
2721953|NCT01083654|Primary|7-day Point-prevalence Smoking Abstinence|Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (< 10 parts per million CO is indicative of no smoking).|6 months||||Number of abstinent participants|||Number
2721954|NCT01083641|Secondary|Median Overall Survival (OS)||Up to 4 years||||months||95% Confidence Interval|Median
2721955|NCT01083641|Secondary|Progression-free Survival (PFS)||Up to 4 years||||months||95% Confidence Interval|Median
2721956|NCT01083641|Secondary|Clinical Benefit (CB)|Defined as complete response, partial response, or stable disease at > 16 weeks|Up to 4 years||||Participants|||Count of Participants
2721957|NCT01083641|Primary|Determine Tumor Objective Response (OR) Rates|OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 4 years||||percentage of participants||95% Confidence Interval|Number
2721999|NCT01083186|Secondary|Homocysteine Values Throughout the Study|The homocysteine normal range 3.5-20 μmol/L.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=the number of participants with evaluable data at given time-points.|||μmol/L||Standard Deviation|Mean
2721960|NCT01083628|Primary|PHQ-9 Depression Symptoms|The PHQ-9 (Patient Health Questionnaire - 9) is commonly used to screen for depression and to monitor progression of depressive symptoms over time. The scores represent the following depression severity: 0-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe, 20-27: severe. A score of 10 is often recommended as the cut-off score for diagnosing an episode of depression that may require treatment.|16 weeks|The number of participants analyzed in this intention-to-treat analyses represents the number of participants that provided PHQ-9 scores at the end of the study period, at 16 weeks. Because the PHQ-9 was filled in during psychotherapy sessions, this number is smaller than the original sample (n=44, n=38) due to patient drop-out of psychotherapy.|||units on a scale||Standard Deviation|Mean
2721961|NCT01083602|Secondary|Over All Survival|Kaplan Meier estimates- median time to event|24 weeks|FAS|||Days||95% Confidence Interval|Median
2721962|NCT01083602|Secondary|Time to Progression|Time from randomization until objective tumor progression; does not include deaths-- Kaplan-Meier estimates|24 weeks|FAS|||Days||95% Confidence Interval|Median
2721963|NCT01083602|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the date of first study treatment to first occurrence of documented progressive disease /relapse or death. Time from randomization until disease progression or death by Kaplan-Meier estimates|24 weeks|Full Analysis Set (FAS)|||days||95% Confidence Interval|Median
2721964|NCT01083602|Secondary|Time to Response (Greater Than or Equal to PR) Based on Investigator Assessment|Time to response is defined as the time from the date of first administration of study treatment to the date of first documented evidence of CR or nCR or PR (whichever status is recorded first). Patients who do not have a response of PR or better by the data cut-off date are censored.|after eight cycyles of treatment (24 weeks)|FAS|||Days||Standard Deviation|Mean
2721965|NCT01083602|Secondary|Responders to Treatment|The primary endpoint for this phase II study of patients with bortezomib-refractory MM is response after a maximum of 8 cycles of therapy as defined by the modified EBMT criteria.|after eight cycyles of treatment (24 weeks)|Full Analysis Set|||participants|||Number
2721966|NCT01083602|Primary|Overall Response Rate (PR+nCR+CR)|Overall response rate=(PR+nCR+CR) CR= < 5% plasma cells in bone marrow. No confirmation on bone marrow plasma cell (additional assessment) is needed to document CR except patients with non-secretory myeloma where the bone marrow examination must be repeated after an interval of at least 6 weeks, Absence of M-protein in serum and urine by immunofixation,nCR same as CR without out Absence of M-protein in serum and urine by immunofixation,PR+ 50% reduction of serum M-protein and sofft tissue Plasmacytomas all for more than 6 weeks.|after eight cycyles of treatment (24 weeks)|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2721967|NCT01083576|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults ages >= 17 years with measurable samples.|||hr/ML||Standard Deviation|Mean
2721968|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.|||1/ML||Standard Deviation|Mean
2721969|NCT01083576|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Paromomycin Alone Treatment had only 5 measureable samples on Day 1, and WR 279,396 had only 4 measureable samples on Day 20.|||hr||Standard Deviation|Mean
2721970|NCT01083576|Other Pre-specified|Serum Creatinine Levels|Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides|Day 1 and Day 20|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.|||mg/dL||Standard Deviation|Mean
2721971|NCT01083576|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.|||ng*hr/mL||Standard Deviation|Mean
2721972|NCT01083576|Secondary|Pharmacokinetic Parameter: Tmax|Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1.|||hr||Standard Deviation|Mean
2721973|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults with measurable samples.|||ng/mL||Standard Deviation|Mean
2721974|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|Days 1 and 20|Children ages 7 to 16|||ng/mL||Standard Deviation|Mean
2721975|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Adults|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4 to Day 28|Adults ages >= 17 years|||ng/mL||Standard Deviation|Mean
2721976|NCT01083576|Secondary|Detectable Paromomycin or Gentamicin Plasma Levels|Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected|20 days|Adults ages >= 17 years|||Participants|||Number
2721977|NCT01083576|Secondary|Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions|Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions)|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.|||Participants|||Number
2721978|NCT01083576|Primary|Number of Participants Who Obtained Final Clinical Cure of Index Lesion|Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion.|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.|||Participants|||Number
2721979|NCT01083485|Secondary|Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets|To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase.|Mean dose during the whole double blind treatment phase (2.5 days)|This is the per protocol population (PP), which is a subset of the full analysis population. The data presented is only for those subjects taking the higher dose (20/10 mg OXN or 20 mg OXY) in the study.|||mg of rescue analgesia||Standard Deviation|Mean
2721980|NCT01083485|Primary|Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)|"The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with 0 = no pain and 10 = worst possible pain. This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value."|Mean of 24 hour pain intensity (absolute change from baseline)|The primary efficacy end point (absolute change from baseline) was analysed on the PP data using a mixed model repeated measures of analysis of covariance (RMANCOVA).|||Units on a scale||95% Confidence Interval|Mean
2721981|NCT01083472|Primary|Hernia Occurrence|Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.|Month 12 after repair|Due to early termination of the study and the low enrollment number (only 37 subjects out of the planned 200 subjects being enrolled), all planned analyses of study endpoints were not performed. The only study results obtained focused on safety. Due to the small sample size these safety results should be interpreted with caution.||||||
2721982|NCT01083368|Other Pre-specified|Prostate Specific Androgen (PSA)|Prostate Specific Androgen (PSA) at baseline|at baseline|All participants that received treatment for both arms. Data no longer available per intervention arms - reported combined.|||ng/mL||Full Range|Median
2721983|NCT01083368|Other Pre-specified|Presence of Circulating Tumor Cells and Single Nucleotide Polymorphism Status|To determine the presence of circulating tumor cells (CTCs) and status of single nucleotide polymorphism (SNPs) in CRPC patients.|at end of treatment|||||||
2721984|NCT01083368|Secondary|Number of Patients With Toxicity as Assessed by CTCAE v3.0 (Common Toxicity Criteria for Adverse Effects)|To further evaluate the safety of temsirolimus given in combination with AVASTIN in chemotherapy refractory metastatic CRPC patients at the dose established in our phase I safety phase. Specific toxicities are listed in the SAE and AE results.|at 24 weeks|All participants who received treatment at the MTD (Dose level 2)|||participants|||Number
2721985|NCT01083368|Secondary|Overall Survival|Time in months from on study to time of death|baseline to end of study, up to 3.5 years|All participants that received treatment. Data no longer available per intervention arms - reported combined.|||months||Full Range|Median
2721986|NCT01083368|Secondary|Time to Clinical Progression|To evaluate the effect of the combination of temsirolimus and AVASTIN on time (in months) to clinical progression from start of treatment. Progressive Disease according to RECIST Criteria is defined as : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|12 weeks|All participants that received treatment. Data no longer available per intervention arms - reported combined.|||months||95% Confidence Interval|Median
2721987|NCT01083368|Primary|Objective Response (Dose Level 2)|PSA (Prostate-Specific Antigen) test will be performed every 4 weeks prior to receiving treatment. PSA response will be measured as the number of participants that had a decline observed from baseline.|change from baseline to 12 weeks|Participants with available serial PSA data (at both baseline and 12 weeks) who received the MTD dose of Temsirolimus 25 mg.|||Participants|||Count of Participants
2721988|NCT01083368|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus (Phase I)|Participants received temsirolimus (20mg or 25mg IV weekly) in combination with a fixed dose of IV bevacizumab (10mg/kg every 2 weeks). The MTD was determined to be the dose at which no unacceptable toxicities were observed.|at 24 weeks|Subjects that received treatment for the Dose escalation portion of the study.|||mg|||Number
2721989|NCT01083316|Secondary|Number of Participants Surviving at 5 Years||5 years|number of patients that completed at least one cycle of induction therapy|||Participants|||Count of Participants
2721990|NCT01083316|Primary|Number of Participants Proceeding to Transplant Following Induction||2 months||||Participants|||Count of Participants
2721991|NCT01083316|Primary|Number of Participants Surviving at 100 Days Post Transplant||100 days||||Participants|||Count of Participants
2721992|NCT01083316|Primary|Number of Participants With Disease Response|Complete response: Normal serum free light chain ratio and Negative serum and urine immunofixation electrophoresis Very good partial response: Difference in serum free light chains less than 40 mg/L Partial Response: >50% Reduction in the difference in serum free light chains|One year||||Participants|||Count of Participants
2721993|NCT01083199|Secondary|Bladder Neck Contracture (BNC) Rate||Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal|||||||
2721994|NCT01083199|Secondary|Incontinence Rate and I-QOL Score||Baseline, 6-week, 6 and 12-month evaluations|||||||
2721995|NCT01083199|Secondary|Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits||7 and 14 days post-Device placement|||||||
2721996|NCT01083199|Secondary|Intraoperative/Postoperative Parameters||At Device placement|||||||
2721997|NCT01083199|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement|"Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window.~The following defines the timeframe of each removal attempt:~7-day window (7-10 days post-implant)~14-day window (13-15 days post-implant)~21-day window (19-21 days post-implant)"|7-21 days post-Device placement||||participants with device removal by 21d|||Number
2722001|NCT01083186|Secondary|Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12|The HDL-C normal range was 35-90 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2722002|NCT01083186|Secondary|Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12|The LDL-C normal range was 0-150 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2722003|NCT01083186|Secondary|Change From Enrollment in Triglyceride Levels at Months 6 and 12|The normal range for triglycerides was 0-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2722004|NCT01083186|Secondary|Change From Enrollment in Total Cholesterol Levels at Months 6 and 12|The total cholesterol normal range was 130-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2722005|NCT01083186|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12|The alkaline phosphatase normal range was 40-129 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||IU/L||Standard Deviation|Mean
2722006|NCT01083186|Secondary|Change From Baseline in Urea Levels at Months 6 and 12|The urea normal range was 10-50 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2722007|NCT01083186|Secondary|Change From Baseline in Creatinine Levels at Months 6 and 12|The creatinine normal range was 0.6-1.4 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
2722008|NCT01083186|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12|The aspartate aminotransferase normal range was 11-38 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||IU/L||Standard Deviation|Mean
2722009|NCT01083186|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12|The alanine aminotransferase normal range was 11-43 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||IU/L||Standard Deviation|Mean
2722010|NCT01083186|Secondary|Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study|The eGFR normal range was 90-120 mL/min/1.73m^2.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mL/min/1.73m^2||Standard Deviation|Mean
2722011|NCT01083186|Secondary|Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study|Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m^2; CKD stage 3: 30-59 mL/min/1.73m^2; CKD stage 4: 15-29 mL/min/1.73m^2; CKD stage 5: <15 mL/min/1.73/m^2. Table presents the number of participants by stage at each study visit.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||participants|||Number
2722012|NCT01083186|Secondary|Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)|In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.|From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.|All participants|||participants|||Number
2722013|NCT01083186|Secondary|Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study|The HbA1c normal range was 4.3-6.1%.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||percent||Standard Deviation|Mean
2722014|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 12|"The values -, Trace, +, ++, and +++ are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6."|Baseline, Month 12|Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment)|||participants|||Number
2722015|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 6|"The values -, Trace, +, ++, and +++ are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6."|Baseline, Month 6|Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment)|||participants|||Number
2722016|NCT01083186|Secondary|Number of Participants With Serum Phosphorus Level Abnormalities|Normal serum phosphorus range was 2.7-4.6 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point|||participants|||Number
2722017|NCT01083186|Secondary|Number of Participants With Serum Calcium Level Abnormalities|Normal serum calcium range was 8.4-10.2 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point.|||participants|||Number
2722018|NCT01083186|Secondary|Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range|Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.|Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=participants with evaluable data at given time point.|||participants|||Number
2722019|NCT01083186|Secondary|Mean Duration of Effect Sustainability (Months)|The effect was considered sustainable if: the participant's intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.|Measured from start of study, up to a maximum of 12 months|All evaluable participants|||months||Standard Deviation|Mean
2722020|NCT01083186|Secondary|Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels|The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).|Measured from start of study, up to a maximum of 12 months|Subset of participants with baseline CKD stage ≥ 3 as well as with available iPTH values greater than the upper limit of the target range, prior to paricalcitol treatment onset. Target range for this specific analysis was defined based on patient’s CKD stage (per baseline eGFR) prior to paricalcitol treatment onset.|||months||95% Confidence Interval|Median
2722021|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Participants with renal transplantation history. n=number of participants with available data at given time-point.|||pg/mL||Standard Deviation|Mean
2722022|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Overall study population. n=number of participants with available data at given time-point.|||pg/mL||Standard Deviation|Mean
2722023|NCT01083173|Primary|Percentage of Participants With Viral Load Below 50 Copies/mL|Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 48|Participants with available data|||percentage of participants|||Number
2722024|NCT01083173|Secondary|Mean Time to Treatment Failure|Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.|From baseline through weeks 24 and 48|Participants with available data|||days||Standard Error|Mean
2722025|NCT01083173|Secondary|Percentage of Participants With Confirmed Viral Resistance|Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.|From baseline through weeks 24 and 48|Participants with available data|||percentage of participants|||Number
2722026|NCT01083173|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts|Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.|From baseline to Weeks 24 and 48|Participants with available data|||cells/mm˄3||Standard Deviation|Mean
2722027|NCT01083173|Secondary|Change From Baseline in Viral Load|This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.|Week 24 & 48|||||||
2722028|NCT01083173|Primary|Percentage of Participants With Viral Load Below 400 Copies/mL|Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 24|Participants with available data|||percentage of participants|||Number
2722029|NCT01083173|Primary|Number of Participants Who Interrupted or Discontinued Kaletra Treatment|At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).|Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment|Participants with available data|||participants|||Number
2722030|NCT01083173|Primary|Number of Participants With Adverse Events|Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.|From the start of treatment until 30 days after the last dose, up to 52 weeks|Participants with available data|||participants|||Number
2722031|NCT01083160|Secondary|Evaluate the Compliance and Clinical Tolerability With Adalimumab|To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section.|Baseline to Week 24|Analysis population included all participants enrolled in the study who took at least one dose of adalimumab.|||Participants|||Number
2722032|NCT01083160|Primary|Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)|Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.|||Units on a scale||Standard Deviation|Mean
2722033|NCT01083160|Primary|Tender Joint Count and Swollen Joint Count|The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.|||Joints||Standard Deviation|Mean
2722034|NCT01083160|Primary|DAS28 (Disease Activity Score in 28 Joints)|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented."|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.|||units on a scale||Standard Deviation|Mean
2722035|NCT01083121|Secondary|Physician's Global Assessment for Effectiveness|The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.|After 3-month treatment|Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation.|||participants|||Number
2722036|NCT01083121|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|From Baseline until up to 70 days after the 3 month study period (total of 160 days).|Safety analysis population|||participants|||Number
2722037|NCT01082965|Secondary|Change From Baseline in CogState Test Battery at Hour 5 on Day 1 and at Hour 0, 5 on Day 8|"Computerized test battery used to assess detection and identification task. CogState detection task: a measure of simple reaction time, provided valid assessment of psychomotor function. Participants were required to press a YES response key as soon as they detected an event (a card turning face up presented in center of the computer screen). The software measured the response time to detect each event. CogState identification task: measure of choice reaction time, provided a valid assessment of visual attention. Participants were required to decide YES or NO as to whether the event met a predefined and unchanging criterion (is the color of the card red?) while the event (a card turning face up) occurred in the center of the computer screen. The software measured the speed and accuracy of each response."|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specific time points for each arm group, respectively.|||log10 milliseconds||Standard Deviation|Mean
2722038|NCT01082965|Secondary|Change From Baseline in Rey Auditory Verbal Learning Test (RAVLT): Immediate and Delayed Recall at Hour 5 on Day 8|RAVLT, in immediate recall (IR) list of 15 words (list A) was read aloud to participant 5 times followed by a test of spontaneous retrieval (A1 to A5). After fifth attempt a list of interference, comprising 15 words (list B) was read to participant followed by its retrieval (B1). After attempt B1 examiner asked individual to recall words from list A, without reading it again (A6). Score range: 0-105, higher scores=less impairment. Delayed recall (DR):after a 20-minute interval examiner asked individual to remember words from list A without reading this list; in recognition performance a list comprising 15 words from list A, 15 words from list B, 20 distracting words (similar to words in list A, B) was read to individual. Upon each word read aloud, individual asked to indicate if it belonged to list A, or not. Score range: 0-30, higher scores=less impairment.|Baseline, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2722039|NCT01082965|Secondary|Change From Baseline in CogState Continuous Paired Associate Learning (CPAL) at Hour 5 on Day 1 and at Hour 1, 5 on Day 8|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. After 4 pictures were placed correctly, second round started. In second round pictures remain in the same locations, but their order of presentation in the center of the screen was different to that of the first round (randomized). The same process was repeated for round 3 and round 4. The outcome was the number of errors made in correctly placing each of the 4 patterns in their location 4 times.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.|||errors||Standard Deviation|Mean
2722040|NCT01082965|Secondary|Change From Baseline in Arterial Spin Label (ASL) Perfusion at Hour 4 on Day 1 and at Hour 0, 4 on Day 8|Perfusion in anterior cingulate cortex, medial prefrontal cortex, precuneus, inferior parietal cortex and other regions of interest (whole brain gray, superior, medial and inferior temporal cortex; inferior and superior prefrontal cortex; insula, amygdala, thalamus, basal ganglia, hippocampus, Landau) was measured by ASL technique. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for relative perfusion rate. Relative perfusion rate is defined as the absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1, 1 minute post-dose (Hour 0), 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2722041|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2722042|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 0 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 1 minute post-dose (Hour 0) on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2722043|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1|Posterior cingulate cortex perfusion was measured by arterial spin labeling (ASL). ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2722044|NCT01082952|Secondary|Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes|The effect of Eosinophil release of Cysteinyl Leukotrienes on ASM proliferation was determined using blocking agents. This was determined using Ki-67 staining and flowcytometry.|one day|Eosinophils were collected from all the participants and used to trigger ASM proliferation.|||Fold increase in ASM proliferation||Standard Deviation|Mean
2722045|NCT01082952|Primary|Fold Increase in ASM Proliferation Following Incubation With Eosinophils.|Airway Smooth Muscle (ASM) cell proliferation was measured 24 hrs following their co-culture with eosinophil. This was determined using Ki-67 staining and flowcytometry. The fold increase in ASM proliferation was then determined.|one day|The number of participants for each group was determined to insure proper statistical significance when analysing the effect of isolated eosinophils on ASM cells proliferation|||Fold increase in ASM cell proliferation||Standard Deviation|Mean
2722046|NCT01082939|Primary|Number of Participants With an Overall Response|Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|6 cycles of treatment (28 days per cycle)||||Participants|||Number
2722047|NCT01082874|Secondary|Individual Secondary Outcomes at 1 Year|All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.|1 year|||||||
2722048|NCT01082874|Secondary|Composite Outcome at 1 Year|All-cause mortality, nonfatal MI, and nonfatal stroke.|1 year|||||||
2722049|NCT01082874|Secondary|Safety Outcomes in Clonidine Trial|Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.|30 days|||||||
2722050|NCT01082874|Secondary|Safety Outcomes in ASA Trial|Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.|30 days|||||||
2722051|NCT01082874|Secondary|Composite Outcome by ASA Stratum|Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.|30 days|||||||
2722052|NCT01082874|Secondary|Individual Secondary Outcomes|All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.|30 days|||||||
2722053|NCT01082874|Secondary|Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke||30 days|||||||
2722054|NCT01082874|Primary|All-cause Mortality and Nonfatal MI||1 year|||||||
2722055|NCT01082874|Primary|Composite of All-cause Mortality and Nonfatal MI||30 days||||participants|||Number
2722056|NCT01082640|Secondary|Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State|Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.|||hr*µg/mL||Standard Deviation|Mean
2722072|NCT01082575|Secondary|Number of Participants With Adverse Events (AE) Caused by no Breathing|Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing|Five Nights|All enrolled patients|||participants|||Number
2722057|NCT01082640|Secondary|Mean Clearance (CL/F) of Febuxostat at Steady State|Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.|||liters/hour||Standard Deviation|Mean
2722058|NCT01082640|Secondary|Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12|Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory.|Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value.|||percentage of participants|||Number
2722059|NCT01082640|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory).|Baseline and Month 12|Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value.|||mL/min/1.73m²||Standard Error|Least Squares Mean
2722060|NCT01082640|Primary|Change From Baseline to Month 12 in Serum Creatinine|Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.|Baseline and Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value.|||mg/dL||Standard Error|Least Squares Mean
2722061|NCT01082614|Secondary|Quality of Recovery Score on Postoperative Day 4|Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery.|Postoperative day 4||||units on a scale||Inter-Quartile Range|Median
2722062|NCT01082614|Secondary|Quality of Recovery Score on Postoperative Day 2|Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery.|Postoperative day 2||||units on a scale||Inter-Quartile Range|Median
2722063|NCT01082614|Primary|Length of Postoperative Hospital Stay|time in days from end of surgery to hospital discharge|within one month||||Days||Full Range|Mean
2722064|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
2722065|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
2722066|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
2722067|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12|The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
2722068|NCT01082588|Primary|Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12|"The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, week 12|One participant from the placebo group refused to complete the MATRICS assessment at week 12; therefore, we could only analyze 24 placebo participants for the final analysis.|||Scores on a scale||Standard Deviation|Mean
2722069|NCT01082588|Primary|Change in C-Reactive Protein (CRP) From Baseline to Week 12||Baseline, week 12||||mg/L||Standard Deviation|Mean
2722070|NCT01082588|Primary|Change in LDL-cholesterol Between Baseline and Week 12||Baseline, week 12|One participant from the pravastatin group and two from the placebo group had triglyceride levels above 400. Per Massachusetts General Hospital Laboratories policy, LDL is not run as a part of the complete metabolic panel (CMP) when triglycerides are above 400, and therefore could not be included in the final analysis.|||mg/dl||Standard Deviation|Mean
2722071|NCT01082575|Primary|Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.|Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.|5 days|93 evaluable patients out of 100 enrolled.|||participants|||Number
2722073|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine|In urine, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percentage of radioactive dose|||Number
2722074|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces|In feces, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percentage of radioactive dose|||Number
2722075|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma|Identification was done by Radio-High Performance liquid chromatography (HPLC) chromatogram. Relative abundance (profiling) of metabolites in chromatogram were determined by dividing sum of radioactive content of fractions contributing to particular peak by sum of radioactive content of all fractions constructing the radio chromatogram. Metabolites accounting for an average of greater than or equal to (>=) 10% of total recoverable radioactivity in plasma were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percentage of recovered radioactivity|||Number
2722076|NCT01082380|Primary|Overall Cumulative Percent Recovery of Radioactivity|Overall cumulative percent of radioactive dose recovered in urine, feces and toilet tissue at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Pre-dose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose for urine and Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose for feces|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percent recovery of radioactivity||Standard Deviation|Mean
2722077|NCT01082380|Primary|Total [14C] Data in Feces|Cumulative amount excreted in feces at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq||Standard Deviation|Mean
2722078|NCT01082380|Primary|Total [14C] Data in Urine|Cumulative amount excreted in urine at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq||Standard Deviation|Mean
2722079|NCT01082380|Primary|Apparent Volume of Distribution of Radioactivity in Whole Blood (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L||Standard Deviation|Geometric Mean
2722080|NCT01082380|Primary|Apparent Oral Clearance of Radioactivity From Whole Blood (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L/hr||Standard Deviation|Geometric Mean
2722081|NCT01082380|Primary|Decay Half-life (t1/2) of Radioactivity in Whole Blood|Decay half life (t1/2) is the time measured for the concentration to decrease by one half in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||hr||Standard Deviation|Mean
2722082|NCT01082380|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Radioactivity in Whole Blood|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
2722083|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Radioactivity in Whole Blood|Area under the concentration time-curve from zero to the last measured concentration (AUClast) in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
2722084|NCT01082380|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in Whole Blood|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||hr||Full Range|Median
2722085|NCT01082380|Primary|Maximum Observed Concentration of Radioactivity in Whole Blood (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq/mL||Standard Deviation|Geometric Mean
2722086|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma Radioactivity|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L||Standard Deviation|Geometric Mean
2722087|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma Radioactivity|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L/hr||Standard Deviation|Geometric Mean
2722088|NCT01082380|Primary|Decay Half Life (t1/2) of Radioactivity in Plasma|Plasma decay half-life is the time measured for the plasma radioactivity concentration to decrease by one half. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||hr||Standard Deviation|Mean
2722089|NCT01082380|Primary|Area Under the Plasma Radioactivity Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in plasma. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
2722090|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Radioactivity Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
2722091|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Radioactivity Concentration (Tmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||hr||Full Range|Median
2722092|NCT01082380|Primary|Maximum Observed Concentration in Plasma Radioactivity (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||nanogram-equivalent/milliliter(ng-eq/mL)||Standard Deviation|Geometric Mean
2722093|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine Expressed as Percent of Dose From Time Zero to Infinite Time [Ae(%)]||Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||Percent dose of unchanged drug||Standard Deviation|Geometric Mean
2722094|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to Infinite Time (Ae)|Ae = concentration of unchanged drug excreted in the urine multiplied by volume of unchanged drug excreted in urine.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||mg||Standard Deviation|Geometric Mean
2722095|NCT01082380|Primary|Renal Clearance (CLr) of PF-02341066|CLr is the volume of plasma from which a substance is completely removed by the kidney in a given amount of time.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||L/hr||Standard Deviation|Geometric Mean
2722096|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||L||Standard Deviation|Geometric Mean
2722097|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma PF-02341066|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||L/hr||Standard Deviation|Geometric Mean
2722098|NCT01082380|Primary|Plasma Decay Half Life (t1/2)|Plasma Decay half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||hr||Standard Deviation|Mean
2722099|NCT01082380|Primary|Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
2722100|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration (AUClast).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
2722101|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||hr||Full Range|Median
2722102|NCT01082380|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (hrs), 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Standard Deviation|Geometric Mean
2722103|NCT01082367|Secondary|Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period|Sputum/throat swab cultures were assessed.|Day 91|Participants from the ITT population, who were tested for microbiology, were included in the analysis.|||Percentage of participants|||Number
2722104|NCT01082367|Secondary|Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 91|Cross-over participants from the ITT population were analyzed.|||Percentage of participants|||Number
2722105|NCT01082367|Primary|Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 29|Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.|||Percentage of participants|||Number
2722106|NCT01082328|Secondary|Mean Change From Baseline in Blood Phenylalanine-to-tyrosine Ratio|Phenylalanine-to-tyrosine ratio is the best indicator of dopamine availability in PKU. The change in blood phenylalanine-to-tyrosine ratio at Day 28 was calculated as blood phenylalanine-to-tyrosine ratio at Day 28 minus blood phenylalanine-to-tyrosine ratio at Baseline.|Baseline, Day 28|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.|||Ratio||Standard Deviation|Mean
2722107|NCT01082328|Secondary|Percentage of Early-, Late- and Partial-Responders According to Phenotype|The PKU is categorized as per phenotype into classical PKU: (blood Phe levels > 1200 mcmol/l), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild HPA (blood Phe levels 300 to 600 mcmol/l). Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Percentage of participants|||Number
2722108|NCT01082328|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes|The Phenylketonuria (PKU) is categorized as per phenotype into classical PKU: (blood Phe levels greater than [>] 1200 micromole per liter [mcmol/l]), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild Hyperphenylalaninaemia (HPA) (blood Phe levels 300 to 600 mcmol/l).|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.|||Percentage of participants|||Number
2722109|NCT01082328|Secondary|Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®|Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment. Non-responders defined as percentage of participants with a Phe level reduction of less than 10 percent within 28 +/- 1 days.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.|||Percentage of participants||95% Confidence Interval|Number
2722149|NCT01081886|Primary|Post-operative Pain|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2722110|NCT01082328|Secondary|Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Day 42 +/- 3|Safety population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.|||Participants|||Number
2722111|NCT01082328|Primary|Percentage of Participants With at Least 30 Percent Reduction From Baseline in Blood Phenylalanine (Phe) Level|Response to treatment was defined as 30 percent reduction from Baseline in blood phenylalanine (Phe) Level during the 28 +/- 1 days.|Baseline up to Day 28 +/- 1|Full analysis set (FAS) population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.|||Percentage of participants||95% Confidence Interval|Number
2722112|NCT01082211|Secondary|12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale|"Patient-Reported BCTOS is comprised of 3 subscales (functional status, cosmetic status, breast specific pain). Responses for each item form a 4-point Likert scale evaluating the differences between the treated and untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). Higher scores reflect poorer outcomes.~Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale:~Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast.~Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast.~Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast.~Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue."|12 Months from the start of radiation treatment.|Eligible patients who consented to participate in the quality of life study and have baseline and 12-month BCTOS data|||units on a scale||Standard Deviation|Mean
2722113|NCT01082211|Secondary|Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale|"Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale:~Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast.~Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast.~Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast.~Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue."|Baseline,12, and 36 Months from the start of radiation treatment.|Eligible patients who consented to participate in the quality of life study and have baseline data|||Participants|||Count of Participants
2722114|NCT01082211|Secondary|Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)|The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 36 months minus the value at baseline. A positive change reflects a decline at 36 months and a negative change reflects an improvement at 36 months.|Baseline and 36 months from the start of radiation treatment.|Eligible patients who consented to participate in the quality of life study and have baseline and 36-month BCTOS data|||units on a scale||Standard Deviation|Mean
2722115|NCT01082211|Secondary|Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)|The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 12 months minus the value at baseline. A positive change reflects a decline at 12 months and a negative change reflects an improvement at 12 months.|Baseline and 12 months from the start of radiation treatment.|Eligible patients who consented to participate in the quality of life study and have baseline and 12-month BCTOS data|||units on a scale||Standard Deviation|Mean
2722116|NCT01082211|Secondary|Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation|AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.|After 1 year from the end of radiation.|All eligible patients|||percentage of participants|||Number
2722117|NCT01082211|Secondary|Overall Survival|Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2722118|NCT01082211|Secondary|Mastectomy-free Survival|Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.|From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2722344|NCT01080300|Secondary|Evaluate Safety of G-ER|Evaluate safety of G-ER,change from average daily frequency & severity score of HFs from baseline to end point(wk 24),assess sleep interference, depression,suicidal ideation, quality of life, patient and investigator global impression of change|6mt treatment, 1mt f/u|||||||
2722119|NCT01082211|Secondary|Distant Metastasis-free Survival|Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.|From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2722120|NCT01082211|Secondary|Treatment-related Adverse Events (AEs) Any Time|AEs were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The overall highest grade for each patient was computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.|From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.|All eligible patients|||percentage of participants|||Number
2722121|NCT01082211|Secondary|Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs)|"CTCs in peripheral blood were assessed using the CellSearch (trademark) system. A stringent algorithm was used to classify cell images as a CTC. A CTC must express EpCAM [epithelial cell adhesion molecule] and not leukocyte lineage-specific antigens, exhibit cytoplasmic expression of cytokeratin, and contain a nucleus that binds DAPI [4',6-doamidino-2-phenylindole]. A cell image is not a CTC if any of the previous criterion are missing. A subject is categorized as Detectable if the patient had a CTC and Undetectable if the subject had no CTCs. If neither category could be determined, then the subject was categorized as Unevaluable."|Prior to the start of radiation and 3 weeks after last radiation treatment.|Eligible patients who consented to participate in the CTC portion of the trial|||Participants|||Count of Participants
2722122|NCT01082211|Secondary|Freedom From Mastectomy|Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.|From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2722123|NCT01082211|Secondary|In-breast Recurrence|The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.|From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2722124|NCT01082211|Primary|Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events|Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.|From the end of radiation to 1 year.|The first 55 eligible patients who completed treatment and achieved 1 year of follow-up.|||participants|||Number
2722125|NCT01082159|Primary|Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).|The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Month 6|All participants at month 6 who completed all questionnaire fields necessary to analyze PCS data according to guidelines.|||units on a scale||95% Confidence Interval|Mean
2722126|NCT01082159|Primary|Function as Measured Subjectively by the Oswestry Disability Index Questionnaire|Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Month 6|All available patients at 6 months are reported below.|||units on a scale||95% Confidence Interval|Mean
2722150|NCT01081873|Secondary|Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline|The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722127|NCT01082159|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|"The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.~The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value."|Baseline and Month 6|All available participants who reported Month 6 outcomes are included in this analysis.|||units on a scale||95% Confidence Interval|Mean
2722128|NCT01082081|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722129|NCT01082081|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722130|NCT01082081|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722131|NCT01082081|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722132|NCT01082081|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722133|NCT01082081|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722134|NCT01082081|Secondary|Total Pain Relief (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722135|NCT01082081|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722136|NCT01082081|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2722137|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours|Percentage of participants who took rescue medication during 2 to 6 hours|Within 2 to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
2722138|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication Within 2 Hours|Percentage of participants who received rescue medication within 2 hours|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
2722139|NCT01082081|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants was calculated.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.|||minutes||Full Range|Median
2722140|NCT01082081|Secondary|Time to Onset of Meaningful Pain Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
2722141|NCT01082081|Secondary|Time to Confirmed First Perceptible Pain Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
2722142|NCT01082081|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 6 hours post dose||||Units on a scale||Standard Deviation|Mean
2722143|NCT01081951|Secondary|Percentage Change in Tumour Size|The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.|Week 9 (+/- 1 week)|FAS, but including only patients with target lesions at baseline|||Percentage change||Standard Error|Least Squares Mean
2722144|NCT01081951|Secondary|Overall Survival (OS)|OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)|FAS|||Participants (Number of deaths)|||Number
2722145|NCT01081951|Primary|Progression Free Survival (PFS)|PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).|Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)|Full Analysis Set (FAS)|||months||95% Confidence Interval|Median
2722146|NCT01081912|Secondary|Mean Change of the Clinic NRS Pain Intensity|The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)|Baseline to Day 85 visit|||||||
2722147|NCT01081912|Primary|Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).|Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.|Baseline to Day 85 (Treatment Phase)|The primary efficacy analysis used the Intent to treat (ITT) population which included all 302 randomized subjects.|||units on a scale||Standard Deviation|Mean
2722148|NCT01081886|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2722151|NCT01081873|Secondary|Epidemiological Data: Bone Scan at Baseline|The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722152|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.|N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722153|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test|In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722154|NCT01081873|Secondary|Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.|The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722155|NCT01081873|Secondary|Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.|The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722156|NCT01081873|Secondary|Epidemiological Data: PSA at Baseline|The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients.|||ng/mL||Full Range|Median
2722157|NCT01081873|Secondary|Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.|Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
2722158|NCT01081873|Secondary|Epidemiological Data: Race|The number of participants by race at baseline is presented.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients.|||participants|||Number
2722159|NCT01081873|Secondary|Epidemiological Data: Mean Age|The mean age of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.|||years||Standard Deviation|Mean
2722160|NCT01081873|Secondary|Epidemiological Data: Mean Weight|The mean weight of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.|||kg||Standard Deviation|Mean
2722161|NCT01081873|Secondary|Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)|The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.|Baseline to disease progression or 24 months, whichever came first|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.|||participants|||Number
2722162|NCT01081873|Primary|Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.|Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
2722163|NCT01081873|Primary|Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months|The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.|time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
2722214|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized|The mean (average) number of days hospitalized per participant for those hospitalized during the study.|Baseline to Month 24 Visit|Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).|||days||Standard Deviation|Mean
2722164|NCT01081873|Primary|Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit|Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.|month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
2722165|NCT01081873|Primary|Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit|The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||ng/mL||Standard Deviation|Mean
2722166|NCT01081873|Primary|Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit|The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
2722167|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
2722168|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2722169|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mmHg||Standard Error|Least Squares Mean
2722170|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
2722171|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
2722172|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
2722173|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)|The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percentage of patients|||Number
2722174|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
2722175|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
2722176|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mmHg||Standard Error|Least Squares Mean
2722177|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
2722178|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
2722179|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
2722180|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (Main Study)|The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percentage of patients|||Number
2722181|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent||Standard Error|Least Squares Mean
2722182|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent||Standard Error|Least Squares Mean
2722183|NCT01081795|Secondary|Short Form-36 Health Survey (SF-36) Score|The SF-36 is a survey of participant health. It consists of 8 scaled scores, which are weighted sums of the questions in their section. The 8 sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each item is scored on a 0-100 range so that total score ranges from 0-100 with high score indicating more favorable health state. Final evaluation was done at Day 155 or at discontinuation for those participants who discontinued before Day 155.|Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW])|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2722184|NCT01081795|Secondary|Percentage of Participants With Response to Study Treatment|Responders were the participants who had at least 50 percent reduction in the average number of monthly migraine attacks.|Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Percentage of participants|||Number
2722185|NCT01081795|Secondary|Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6|Rescue medications are medicines that may be administered to the participants when efficacy of study drug is not satisfactory, or the effect of study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, NSAIDs, ergotamines, triptans and anti-emetics. Average at Month 6 was calculated by dividing total number of rescue drug treatment days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Month 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Error|Least Squares Mean
2722186|NCT01081795|Secondary|Average Number of Rescue Drug Treatment Days|Rescue medications are administered to participants when efficacy of study drug is not satisfactory, or effect of study drug is too great and is likely to cause a hazard to participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), ergotamines, triptans and anti-emetics (drug used to stop vomiting). Average at baseline was calculated by dividing total number of rescue drug treatment days until baseline by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
2722187|NCT01081795|Secondary|Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period|The change from baseline in average number of migraine attacks (as per 24-hour rule) over Week 19 to Week 22 period was calculated by subtracting the baseline value from the average value of the Week 19 to Week 22 period.|Baseline (28 days before randomization), Week 19 to Week 22 Period|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Error|Least Squares Mean
2722188|NCT01081795|Secondary|Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6|As per 48-hour rule, if the symptom of pain due to migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, the 2 migraine attacks should be considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2722189|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attacks until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2722190|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6|Headache days were the days when at least 30-minute migraine and non-migraine headache occurred and were calculated from the headache diaries kept by the participants. Average at given month was calculated by dividing total number of headache days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
2722191|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attack days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
2722215|NCT01081665|Secondary|To Estimate the Incidence of (S)AEs/(S)ADRs|The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||participants|||Number
2724286|NCT01066923|Secondary|Hyperthermia and Hemoconcentration Identified by Retinal Imaging|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise|This measure was not collected. Equipment was not available.||||||
2722192|NCT01081795|Primary|Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6|As per 24-hour rule, if symptom of pain due to migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If the interval between latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks should be considered as 1 migraine attack. If the onset of migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if aura had started. Mean change was calculated by subtracting baseline value from the mean of 6 months value.|Baseline (28 days before randomization) through Month 6|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2722193|NCT01081769|Primary|Number of Participants With a Relapse Event|"Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator's judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose."|from baseline (Day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||number of participants|||Number
2722194|NCT01081769|Secondary|Change From Baseline in Physician's Treatment Satisfaction|Physician's treatment satisfaction was assessed using the physician's treatment satisfaction scale which is designed to rate 4 aspects of treatment (efficacy, safety, mode of administration, and overall satisfaction), each on a scale ranging from 1 (extremely satisfied) to 7 (extremely dissatisfied).|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722195|NCT01081769|Secondary|Change From Baseline in Patient's Treatment Satisfaction|Patient's satisfaction with medication was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is divided into 4 subscales (effectiveness, side effects, convenience, and global satisfaction), with the value of each subscale ranging from 0 to 100. Higher scores indicate greater treatment satisfaction.|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722196|NCT01081769|Secondary|Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score|The SWN-S is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). The total score ranges from 20 to 120 with higher score indicating greater subjective well-being.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722197|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score|"The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A higher score indicates an improvement in health in the Health Status Index."|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722198|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score|The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual respondent.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722199|NCT01081769|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The Short Form-36 Health Survey (SF-36) is a measure of Participant-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary. Each summary scale score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722739|NCT01077973|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.|||Minutes||95% Confidence Interval|Median
2722200|NCT01081769|Secondary|Changes From Baseline in Personal and Social Performance (PSP) Total Score|The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722201|NCT01081769|Secondary|Clinical Global Impression-Change (CGI-C)|The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the patient's illness compared to baseline (day 1 of core phase) on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Month 24 and endpoint|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||percentage of participants|||Number
2722202|NCT01081769|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global clinical assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate higher impression of illness severity."|Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722203|NCT01081769|Secondary|Change From Baseline in PANSS Marder Factor Scores|Change from baseline in schizophrenia symptoms were assessed through the following PANSS factor scores as described by Marder: (1) positive symptoms (range 8-56): sum of delusions, hallucinatory behavior, grandiosity, suspiciousness, stereotyped thinking, somatic concern, unusual thought content, lack of judgment and insight; (2) negative symptoms (range 7-49): sum of blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance; (3) disorganized thoughts (range 7-49): sum of conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, poor attention, disturbance of volition, and preoccupation; (4) uncontrolled hostility/excitement (range 4-28): sum of excitement, hostility, uncooperativeness and poor impulse control; (5) anxiety/depression (range 4-28): sum of anxiety, guilt feelings, tension, and depression. Higher scores indicate higher severity of symptoms|Baseline (day 1 of core phase), day 8, month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722204|NCT01081769|Secondary|Change From Baseline in PANSS Subscale Score|Change from baseline in positive symptom, negative symptom and general psychopathology subscales of the PANSS scale. The PANSS scale is designed to assess symptoms of schizophrenia by means of the 30-items. The PANSS scale provides subscores for 3 subscales, that is, the positive symptoms subscale (7 items, range 7-49), the negative symptoms subscale (7 items, range 7-49), and the general psychopathology subscale (16 items, range 16-112). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). Higher scores indicate higher severity of schizophrenia symptoms.|Baseline (day 1 of core phase), day 8, month 12, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722205|NCT01081769|Secondary|Change From Baseline in PANSS Total Score|Change from baseline in the PANSS: The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
2722206|NCT01081769|Secondary|Percentage of Treatment Responders|The proportion of patients achieving a treatment response, defined as a ≥30% decrease (i.e., improvement) in Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint. The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate increased severity of schizophrenia symptoms.|from baseline (day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||percentage of participants||95% Confidence Interval|Number
2722216|NCT01081665|Secondary|The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product|The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||Participants|||Number
2722808|NCT01077804|Secondary|Number of Participants With an Occurrence of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed cases.|From 6 weeks to 168 months (14 years) post vaccination||||Participants|||Number
2722207|NCT01081769|Primary|Time to First Relapse Event|"Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator's judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose."|from baseline (Day 1 of core phase) up to maximally 24 months.|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||days||Standard Error|Mean
2722208|NCT01081678|Secondary|Hip Pain Score at Each Visit|"Hip pain was assessed using a visual analog scale (VAS). Participants were asked to rate their pain as a result of the hip fracture on a 100 mm vertical scale with 0 indicating no pain at all and 100 indicating the worst pain they could imagine.~LSMs were based on a repeated measures model fitted with hip pain score values at weeks 2, 6, 12, 16, 20, 24, 36, and 52 as the dependent variable and adjusted for treatment, randomized strata, gender, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction."|Weeks 2, 6, 12, 16, 20, 24, 36, and 52|Randomized participants who received at least 1 dose of study drug with available data at each time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2722209|NCT01081678|Secondary|Harris Hip Score At Each Visit|The Harris Hip Score is a clinician-based outcome that assesses pain, function, deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities and gait. Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. The score ranges form 0-100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points). LSMs were based on a repeated measures model fitted with the Harris hip score values at weeks 2, 6, 12, 16, 20, 24, 36, and 52 as the dependent variable and adjusted for treatment, randomized strata, gender, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.|Weeks 2, 6, 12, 16, 20, 24, 36, and 52|Randomized participants who received at least 1 dose of study drug with available data at each time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2722210|NCT01081678|Secondary|Radiographic Union Scale for Hip (RUSH) Score At Each Visit|The radiographic Union Scale for Hip (RUSH) is a semiquantitative scoring assessment to assess hip fracture healing after surgical repair. The RUSH has 4 key domains based on radiographic parameters used by orthopedic surgeons and radiologists in routine clinical practice including cortical bridging (4 to 12 points), cortical fracture line disappearance (4 to 12 points), trabecular consolidation (1 to 3 points), and trabecular index disappearance of fracture line (1 to 3 points). The score has a minimum of 10 points (definitely not healed) and a maximum of 30 points (definitely healed).|Weeks 2, 6, 12, 16, 20, 24, 36, and 52|Randomized participants who received at least 1 dose of study drug, with available data at baseline and at each time point. Missing RUSH scores for participants who were still on study were imputed using the using last observation carried forward procedure when possible.|||units on a scale||Standard Deviation|Mean
2722211|NCT01081678|Secondary|Time to Radiographic Healing|"Time to radiographic healing is the time interval from the surgery date for the eligible hip fracture to the date of radiographic healing, defined as effacement of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs. Radiographic fracture healing was determined by a panel of independent reviewers blinded to treatment.~The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate."|52 weeks|All randomized participants who received at least one dose of study drug.|||weeks||95% Confidence Interval|Median
2722212|NCT01081678|Secondary|Timed-Up-and-Go (TUG) at Each Visit|"During the timed-up-and-go test the clinician timed the participant while they stood up from a seated position in a chair, walked 3 meters, turned around, walked 3 meters back to the chair, and returned to a seated position. A TUG value of ≤ 10 seconds is considered normal for a healthy elderly person.~LSMs were based on a repeated measures model adjusting for treatment, randomized strata, gender, country category, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.~Missing TUG values for participants still on study were imputed using the last observation carried forward (LOCF) when possible. If no observation could be carried forward, the maximum TUG value observed among all participants at a given visit was used. TUG values obtained after unplanned revision surgery were replaced by carrying forward the last available observed or imputed value prior to unplanned revision surgery."|Weeks 2, 6, 12, 16, 20, 24, 36, and 52|Randomized participants who received at least 1 dose of study drug. LOCF imputation was used when possible, as described above.|||seconds||95% Confidence Interval|Least Squares Mean
2722213|NCT01081678|Primary|Timed-Up-and-Go (TUG) Over Week 6 Through Week 20|"Functional healing was measured by the timed-up-and-go test (TUG) over Weeks 6 through 20. During this assessment, the clinician timed the participant while they stood up from a seated position in a chair, walked three meters, turned around, walked three meters back to the chair, and returned to the seated position. A TUG value of ten seconds or less was considered normal for a healthy elderly person. Higher TUG values after hip fracture have been shown to be a predictor of future falls.~Least squares mean (LSM) estimates were based on a repeated measures model fitted with the log-transformed TUG values at weeks 2, 6, 12, 16, 20, 24, 36, 52 as the dependent variable and adjusted for treatment, randomized strata, gender, country category, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction and back-transformed using the exponential transformation."|Weeks 6, 12, 16, and 20|Randomized participants who received at least one dose of study drug with available data at each time point.|||seconds||95% Confidence Interval|Least Squares Mean
2722217|NCT01081665|Secondary|The Incidence of Clinically Significant Hyperphosphatemia|The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||Participants|||Number
2722218|NCT01081665|Secondary|The Incidence of Clinically Significant Hypercalcemia|The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||Participants|||Number
2722219|NCT01081665|Secondary|The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)|Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.|Baseline to Month 24 Visit|Analysis based on the evaluable population, defined as participants with baseline and at least 2 post-baseline parathormone measurements at the 24-month post-treatment follow-up visit.|||percentage of participants|||Number
2722220|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations|The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||participants|||Number
2722221|NCT01081626|Secondary|Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire|Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.|On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
2722222|NCT01081626|Secondary|Total Follicle Stimulating Hormone (FSH) Dose||End of stimulation cycle (less than or equal to [<=] 35 days|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||IU||Standard Deviation|Mean
2722223|NCT01081626|Secondary|Duration of Follicle Stimulating Hormone (FSH)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||Days||Standard Deviation|Mean
2722224|NCT01081626|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||participants|||Number
2722225|NCT01081626|Secondary|Number of Participants With Cancelled Cycles|Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.|End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
2722226|NCT01081626|Secondary|Number of Participants Who Received Human Chorionic Gonadotropin (hCG)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
2722227|NCT01081626|Secondary|Number of Participants With Injection Tolerability|Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||participants|||Number
2722228|NCT01081626|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||participants|||Number
2722229|NCT01081626|Secondary|Number of Participants With Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit.|||participants|||Number
2723230|NCT01075204|Secondary|Dyspnea Status at End of Study|Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.|10 days|All enrolled patients|||participants|||Number
2722230|NCT01081626|Secondary|Number of Participants With Multi-follicular Development|Multi-follicular development was defined as the development of more than 3 follicles >= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
2722231|NCT01081626|Primary|Percentage of Participants With a Mono-follicular Development|Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The Intention-To-Treat (ITT) population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||percentage of participants|||Number
2722232|NCT01081301|Secondary|SF12: Physical Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2722233|NCT01081301|Secondary|Non-Death Revised Grief Experience Inventory|The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2722234|NCT01081301|Secondary|General Self-Efficacy Score (GSES)|The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2722235|NCT01081301|Secondary|SF12 Mental Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|baseline, 1 and 2 wks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2722236|NCT01081301|Primary|Herth Hope Index|The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2722237|NCT01081262|Other Pre-specified|Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene|Will be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined.|Baseline|||||||
2722238|NCT01081262|Secondary|Patient Reported Quality of Life|Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL|baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5|All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.|||units on a scale||Standard Deviation|Mean
2722239|NCT01081262|Secondary|Patient Reported Neurotoxicity|Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.|baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5|Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.|||units on a scale.||Standard Deviation|Mean
2722240|NCT01081262|Secondary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years|All randomized patients with measurable disease|||Percentage of Participants||95% Confidence Interval|Number
2722241|NCT01081262|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.|All Randomized Patients|||Months||95% Confidence Interval|Median
2722242|NCT01081262|Secondary|Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0|Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.|Every cycle while on treatment, up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
2722243|NCT01081262|Primary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.|Up to five years|All randomized patients|||months||95% Confidence Interval|Median
2722244|NCT01081249|Secondary|Subjective Ratings of Anxiety and Trust of the Therapist|Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session.|measured before drug, immediately before session, and after the session|||||||
2722245|NCT01081249|Secondary|Heart Rate Variability (HRV)|HRV will be measured before, during and after the therapy session.|continuously monitored from time before drug delivery to 20 minutes after session|||||||
2722246|NCT01081249|Secondary|Salivary Cortisol|Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.|before drug, before session, and 20 minutes after session|||||||
2722247|NCT01081249|Primary|Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug|Videotapes of 2 therapy session (PBO/OT) were reviewed by blinded raters to determine differences in two treatments. There were nine aspects analyzed using the Ethological Coding System for Interviews: eye contact, affiliation, submission, prosocial, flight, assertion, displacement, relaxation, and gesture.|videotapes of session were reviewed and scored 1-3 months after the patient completes the study||||Number of behaviors exhibited||Standard Deviation|Mean
2722248|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Open-Label Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|13 weeks|Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study.|||participants|||Number
2722249|NCT01081145|Secondary|HUI 2/3 Scores During the Open-Label Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|13 weeks|Open-label FAS|||units on a scale||Standard Deviation|Mean
2722250|NCT01081145|Secondary|Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Open-label FAS|||units on a scale||Standard Deviation|Mean
2722251|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|13 weeks|Open-label FAS|||percentage of participants|||Number
2722252|NCT01081145|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|13 weeks|Open-label FAS|||percentage of participants|||Number
2722253|NCT01081145|Secondary|Percentage of Responders in the Open-Label Phase - LOCF|Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of >=30% and a CGI-S score of 1 or 2.|13 weeks|Open-label FAS|||percentage of participants|||Number
2722254|NCT01081145|Secondary|Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 13 weeks|Open-label Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of any investigational product during the study. The Subjects from Site 801 were excluded from the Open-label FAS.|||units on a scale||Standard Deviation|Mean
2722255|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|26 weeks|Randomized Safety Population defined as all subjects who were randomized and who took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase.|||participants|||Number
2724287|NCT01066923|Secondary|Activation of Coagulation|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise|This measure was not collected. Equipment was not available.||||||
2722256|NCT01081145|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|26 weeks|Randomized FAS|||units on a scale||Standard Deviation|Mean
2722257|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 26|Randomized FAS|||units on a scale||Standard Error|Least Squares Mean
2722258|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|26 weeks|Randomized FAS|||percentage of subjects|||Number
2722259|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and week 26|Randomized FAS|||units on a scale||Standard Error|Least Squares Mean
2722260|NCT01081145|Secondary|Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized FAS|||Days||95% Confidence Interval|Median
2722261|NCT01081145|Primary|Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized Full Analysis Set (FAS) defined as all subjects who were randomized and took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. Subjects from Site 801 were excluded from the Randomized FAS.|||percentage of treatment failures||95% Confidence Interval|Number
2722262|NCT01081132|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||participants|||Number
2722263|NCT01081132|Secondary|Structure Side-Effect Questionnaire (SSEQ)|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' or 'no' on the checklist for each of the events listed.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||participants|||Number
2722264|NCT01081132|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
2722265|NCT01081132|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline through week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722266|NCT01081132|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13|Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722267|NCT01081132|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|weeks 1 through 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of subjects|||Number
2724288|NCT01066923|Primary|Vascular Function Measured by Peripheral Arterial Tonometry|Reactive Hyperemia Index|Baseline, 30, 60, and 90 minutes post exercise||||ratio (Reactive Hyperemia Index)||Standard Deviation|Mean
2722268|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722269|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722270|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722271|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722272|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722273|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Global Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722274|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722275|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722276|NCT01081132|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2722277|NCT01081132|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|Baseline through week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of subjects|||Number
2722278|NCT01081132|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline through week 13|The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits.|||units on a scale||Standard Error|Least Squares Mean
2722279|NCT01081041|Secondary|Area Under the Concentration Curve (AUC) of Cetuximab at Steady State|A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (250 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|||micrograms*hours/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2722313|NCT01080807|Secondary|Change From Baseline to Week 3 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 3|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
2722280|NCT01081041|Secondary|Cmax of Cetuximab at Steady State|A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2722281|NCT01081041|Secondary|Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing|The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy.|Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m²) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy..|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2722282|NCT01081041|Secondary|Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)|Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2722283|NCT01081041|Secondary|Number of Participants With Anti-Cetuximab Antibodies||Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).|Participants who received at least 1 dose of study drug and had evaluable data for antibodies.There was no pre-specified analysis plan for trial to report immunogenicity results separately for each arm,as results were intended to be pooled and combined with other cetuximab trials data.Data was pooled for the three arms for cetuximab in this trial.|||participants|||Number
2722284|NCT01081041|Secondary|Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version [v]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)*100.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2722285|NCT01081041|Secondary|Progression-Free Survival (PFS)|PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant's last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)|All participants who received at least one dose of study drug. 7 participants were censored in Safety Lead-In ,12 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).|||Months||95% Confidence Interval|Median
2722286|NCT01081041|Secondary|Overall Survival (OS)|OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)|All participants who received at least on dose of study drug. 4 participants were censored in Safety Lead-In, 17 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).|||Months||95% Confidence Interval|Median
2722287|NCT01081041|Primary|Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013|January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized.|||participants|||Number
2722314|NCT01080807|Secondary|Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
2724289|NCT01066923|Primary|Platelet Closure Time||0, 30, 60, and 90 minutes post exercise||||seconds||Inter-Quartile Range|Median
2722288|NCT01081041|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013|September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized. Data is confounded for 9 participants in BI-manufactured cetuximab treatment arm who switched to US commercial cetuximab.|||participants|||Number
2722289|NCT01080976|Primary|Search Engine Preference|Based on the results of primary outcome 1 (Website Ranking), preference for search engine was measured qualitatively between Google and Health-on-the-Net.|Immediate||||Participants|||Count of Participants
2722290|NCT01080976|Primary|Website Ranking|Primary care and diabetes clinicians' preference in a set of webpage search results on a visual analog scale (1-100) with 1 being the lowest preference and 100 being the highest. Rankings based on qualitative measures, such as perceived clinical relevance, perceived accuracy of content, and perceived timeliness of content.|Immediate|Participants were asked to rank 10 pages of website search results from Google and HoN search engines based on clinician preference. Clinicians were further asked for feedback and opinions on how they determined their ranking. Rankings of individual websites were done by visual analog scale, from 1-100, with 100 indicated as highly preferred.|||units on a scale|||Number
2722291|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
2722292|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
2722293|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
2722294|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
2722295|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score|FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
2722331|NCT01080677|Secondary|Percentage of Participants Experiencing at Least One Adverse Event of Interest|Adverse events may have included abdominal pain, flushing, dizziness, insomnia, or anxiety|24 hours||||percentage of participants|||Number
2722332|NCT01080677|Secondary|Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol||2 hours||||percentage of participants|||Number
2722296|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score|FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
2722297|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
2722298|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
2722299|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
2722300|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
2722301|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2722302|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2722303|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2722333|NCT01080677|Primary|Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)||2 hours||||percentage of participants|||Number
2722304|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation (or last observation after baseline))|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2722305|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2722306|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2722307|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 6|||Percentage of participants|||Number
2722308|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 3|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 3|||Percentage of participants|||Number
2722309|NCT01080807|Secondary|Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
2722310|NCT01080807|Secondary|Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 3|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
2722311|NCT01080807|Secondary|Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
2722312|NCT01080807|Secondary|Change From Baseline to Week 6 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 6|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
2722315|NCT01080807|Primary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2722316|NCT01080794|Secondary|The Number All Types of Adverse Events.|To establish the safety and tolerability of rTMS in Parkinson's Disease.|Baseline through Month 6||||incidents of an adverse event|||Number
2722317|NCT01080794|Secondary|Global Impression Scales|To assess symptom severity and treatment response in Parkinson's Disease. The CGI mean scores were reported for each group at each time point. The CGI Score Range is 1 - 8, where higher the score indicates greater severity of illness or worsening of illness.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722318|NCT01080794|Secondary|Beck Depression Inventory (BDI-II)|To assess mood symptoms in Parkinson's Disease. The BDI-II mean scores were reported for each group at each time point. The BDI-II Score Range is 0 - 63, where higher the score indicates greater severity of the mood symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722319|NCT01080794|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Parts I, II, and IV|"To assess apathy, cognition, depression, activities of daily living (ADL), quality of life (QOL), and motor symptoms in Parkinson's Disease.~The UPDRS I, II, IV total mean scores were reported for each group at each time point. The UPDRS I, II, IV scores were added together for each patient, with a total score range of 0 - 91, where higher the score indicates greater severity of the symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722320|NCT01080794|Secondary|Montreal Cognitive Assessment (MoCA)|To screen and follow cognitive function in Parkinson's Disease. The MoCA mean scores were reported for each group at each time point. The MoCA Score Range is 0 - 30, where 26-30 indicates normal cognition.|pre-treatment; 0,1,3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2722321|NCT01080794|Secondary|Parkinson's Disease Questionnaire 39 (PDQ-39)|To assess the quality of life (QOL) in Parkinson's Disease. The PDQ-39 mean scores were reported for each group at each time point. The PDQ-39 Score Range is 0 - 156, where higher the score indicates greater impact on quality of life.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722322|NCT01080794|Secondary|Apathy Evaluation Scale (AES)|To evaluate apathy in Parkinson's Disease. The AES mean scores were reported for each group at each time point. The AES Score Range is 0-42, where higher the score indicates greater severity of the apathy symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722323|NCT01080794|Secondary|Clinical Anxiety Scale (CAS)|To evaluate anxiety in Parkinson's Disease. The CAS mean scores were reported for each group at each time point. The CAS Score Range is 0 - 100, where higher the score indicates greater severity of the anxiety symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722324|NCT01080794|Primary|Hamilton Depression Scale (HAM-D)|"To evaluate the depressive mood symptoms in PD.~The HAM-D mean scores were reported for each group at each time point. The HAM-D Score Range is 0 - 56, where higher the score indicates greater severity of depressive mood symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722325|NCT01080794|Primary|Motor Subscale of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|"To evaluate the motor symptoms in Parkinson's Disease.~The UPDRS-III mean scores were reported for each group at each time point. The UPDRS-III Score Range is 0 - 56, where higher the score indicates greater severity of the motor symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
2722326|NCT01080768|Primary|Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method|AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.|Baseline, 4 weeks|The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.|||mL||Standard Error|Least Squares Mean
2722327|NCT01080716|Secondary|Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study|Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI|Days 1, 7, 14, and 28|Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI. Results were not presented per arm in the FCSR, but were instead presented as parts 1 and 2 of the study.|||Participants|||Count of Participants
2722328|NCT01080716|Primary|Number of Participants With Shigella Induced Clinical Disease in Part 2|Study Part 2-Frequency of Shigella induced clinical disease defined as one or more of diarrhea, dysentery or fever in vaccinees and controls following challenge with S. sonnei 53G. Transmissibility of disease will be evaluated by the presence of fecal shedding in control subjects.|0-5 days|Number of participants in vaccine and controls following the challenge who experienced one or more clinical disease criteria|||Participants|||Count of Participants
2722329|NCT01080716|Primary|Number of Participants With Adverse Events|Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs|Up to 12 months||||Participants|||Count of Participants
2722330|NCT01080677|Secondary|Percentage of Participants With Treatment Satisfaction|Following up to 24 hours after treatment, participants were asked to report whether they were satisfied with level of pain relief provided by treatment|24 hours||||percentage of participants|||Number
2722334|NCT01080625|Primary|Occurrence of Postreperfusion Syndrome (PRS)|the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group|immediately after reperfusion|Initial assessment for eligibility: n=128 32 patients who did not meet the criteria were excluded 96 patients were randomized Contorol (32 patients) --> 1 patient was excluded because of portalvein rupture Epinephrine (33 patients) --> data recording error (1 patient) practice error (1 patient) Phenylephrine group (31 patient)|||percentage of participants|||Number
2722335|NCT01080391|Secondary|Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores|Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.|Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18|ITT analysis set participants with a baseline value.|||scores on a scale||Standard Deviation|Mean
2722336|NCT01080391|Secondary|Duration of Disease Control|Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.|The Intent to treat (ITT) population with participantants who achieved disease control.|||months||95% Confidence Interval|Median
2722337|NCT01080391|Secondary|Duration of Response|Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.|The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better.|||months||95% Confidence Interval|Median
2722338|NCT01080391|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants|||percentage of participants||95% Confidence Interval|Number
2722339|NCT01080391|Secondary|Overall Response Rate|Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants|||percentage of participants||95% Confidence Interval|Number
2722340|NCT01080391|Secondary|Overall Survival|Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.|From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.|ITT analysis set comprised of all randomized participants|||months||95% Confidence Interval|Median
2722341|NCT01080391|Primary|Progression-free Survival (PFS)|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants|||months||95% Confidence Interval|Median
2722342|NCT01080326|Primary|Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair|"At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage.~Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated."|2 days post-operation||||participants|||Number
2722343|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|"To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline."|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population|||scores on a scale||95% Confidence Interval|Least Squares Mean
2722345|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population|||hot flashes||95% Confidence Interval|Least Squares Mean
2722346|NCT01080261|Secondary|Clinical Procedural Success (Percentage of Participants)|Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.|While participant is in the hospital|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722347|NCT01080261|Secondary|Technical Success (Percentage of Stents)|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|At time of index procedure|Analysis was intention to treat|||percentage of stents|Participants||Number
2722348|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days - 9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722349|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|0-30 Days (Early)|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722350|NCT01080261|Secondary|Target Lesion Failure (TLF) (Percentage of Participants With an Event)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722351|NCT01080261|Secondary|Target Vessel Failure (TVF) (Percentage of Participants With an Event)|Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722352|NCT01080261|Secondary|Target Lesion Revascularization (Percentage of Participants With an Event)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR.|9 months|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722353|NCT01080261|Secondary|Target Vessel Revascularization (Percentage of Participants With an Event)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722354|NCT01080261|Secondary|Cardiac Death (Percentage of Participants With an Event)|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722355|NCT01080261|Secondary|All-cause Death (Percentage of Participants With an Event)|Participants who died from any cause|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722493|NCT01079182|Secondary|Mean Participant Pain Score|Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Score on scale||Standard Deviation|Mean
2722356|NCT01080261|Secondary|Myocardial Infarction (MI) (Percentage of Participants With an Event)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722357|NCT01080261|Primary|Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)|A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2722358|NCT01080248|Secondary|Overall Survival||1 year||||participants|||Number
2722359|NCT01080248|Secondary|Median Survival||Length of follow-up was 35 weeks||||weeks||Full Range|Median
2722360|NCT01080248|Secondary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time to progression.~Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment.|||weeks|||Number
2722361|NCT01080248|Primary|Response Rate by RECIST Criteria.|"Response rate = complete response + partial response per RECIST~Complete response - disappearance of all target and non-target lesions.~Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter"|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment. The remaining participant had progressive disease per RECIST while on treatment.|||percentage of participants|||Number
2722362|NCT01080209|Secondary|Number of Patients With Vision Loss in the Study Eye|Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.|Baseline of Parent Study, Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study|||Patients|||Number
2722363|NCT01080209|Primary|Number of Patients With No Visible Implants in the Study Eye|Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.|Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study|||Patients|||Number
2722364|NCT01080196|Other Pre-specified|Six Minute Walk Distance (6 MW) (m)|"The 6 min walk (6 MW) test, a measure of the distance (m) a subject walks in 6 min, was used to assess overall mobility. Self-selected gait-speed was measured over a 50-ft course. Individuals were instructed to walk at a comfortable pace starting at the word go. They were asked to walk out 25-ft and back. Timing took place from the command go until the starting line was crossed on the way back. Participants were allowed to use any walking aid they used on a daily basis."|12 months||||Six Minute Walk Distance (m)||95% Confidence Interval|Mean
2722365|NCT01080196|Other Pre-specified|Activities Specific Balance Confidence (ABC) (%)|"Self-reported level of balance confidence was assessed with the Activities Specific Balance Confidence (ABC) Scale. This 16-item questionnaire asks participants to score their level of confidence in performing situation-specific activities such as reaching at eye level, reaching on tiptoes, picking up slipper from floor, and walking in crowded mall without losing . . . balance or becoming unsteady. Each item is scored from 0 to 100%, with 0% being no confidence and 100% being full confidence in the ability to perform the activity without losing balance. The total ABC Scale score is the average sum of the individual item scores."|12 months||||percent||95% Confidence Interval|Mean
2722366|NCT01080196|Other Pre-specified|Leg Extension Power (W)|Leg extension power in watts (W) of each leg individually was measured on a Nottingham power rig. After three warm-up trials at 50%, 75%, and 100% effort, six test trials and the average of the three highest trials per leg were recorded.|12 months||||Leg Extension Power (W)||95% Confidence Interval|Mean
2722367|NCT01080196|Other Pre-specified|Thigh Lean Tissue Cross Sectional Area (CSA) (cm^2)|Magnetic resonance imaging (MRI) was used for determination of the cross-sectional area (CSA) (cm^2) of lean muscle mass. Bilateral MRI scans of the thighs were obtained in a coronal plane and the midpoint of the thigh was determined and defined as halfway between the superior margin of the femoral head and the inferior margin of the femoral condyles. Axial imaging (5 mm thick slices at 1 cm intervals) of the legs was then performed over 1/2 the length of the femur, centered at the midpoint of the thigh. Five images from the middle 1/3 of each thigh were used to determine average CSA of lean tissue.|12 months||||Thigh Lean Tissue CSA (cm^2)||95% Confidence Interval|Mean
2722368|NCT01080196|Primary|The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study||12 months||||The number of days survived without a fa||Standard Error|Mean
2722399|NCT01080131|Secondary|Time to Complete Resolution of Pain; Survival Analysis|Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS): All patients that received study drug.|||hours||95% Confidence Interval|Number
2722369|NCT01080131|Secondary|Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab|"Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||mg/L||Standard Deviation|Mean
2722370|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab|"High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||mg/L||Standard Deviation|Mean
2722371|NCT01080131|Secondary|Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
2722372|NCT01080131|Secondary|Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for swelling on the following 4-point scale:~no swelling;~palpable;~visible;~bulging beyond the joint margins.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
2722373|NCT01080131|Secondary|Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for tenderness on the following 4-point scale:~no pain;~participant states that there is pain;~participant states there is pain and winces;~participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
2722374|NCT01080131|Secondary|Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|"The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.~The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
2722412|NCT01079962|Secondary|Change From Baseline in Heart Rate at Week 4 and Week 12|The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Beats per minute (bpm)||Standard Deviation|Mean
2722375|NCT01080131|Secondary|Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
2722376|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab|"Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
2722377|NCT01080131|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Participants met the definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.~Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||flares per patient per year||95% Confidence Interval|Mean
2722378|NCT01080131|Secondary|Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before flare has resolved completely."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||days||95% Confidence Interval|Median
2722379|NCT01080131|Secondary|Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme|For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.|From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.|||Percentage of participants|||Number
2722380|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
2722381|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|"For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. N indicates the number of participants with available data in each analysis."|||mg/L||95% Confidence Interval|Least Squares Mean
2722426|NCT01079949|Secondary|Number and Quality of Embryos|Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who continued with follicular development."|||embryos|||Number
2722382|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.|||participants|||Number
2722383|NCT01080131|Secondary|Physician's Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
2722384|NCT01080131|Secondary|Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported."|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
2722385|NCT01080131|Secondary|Patient's Global Assessment of Response to Treatment|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
2722386|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks|This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During 24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment|||Participants|||Number
2722387|NCT01080131|Secondary|Physician's Global Assessment of Response to Treatment|The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment).|72 hours post-dose and 24-weeks post-dose.|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point.|||percentage of participants|||Number
2722388|NCT01080131|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.|||mg||Standard Deviation|Mean
2722389|NCT01080131|Secondary|Percentage of Participants Who Took Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.|||percentage of participants|||Number
2722465|NCT01079598|Secondary|Cessation of Flow Through the Perforator Vein|Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
2722390|NCT01080131|Secondary|Time to First Intake of Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.~Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks)."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.|||hours||95% Confidence Interval|Median
2722391|NCT01080131|Secondary|Mean Number of New Gout Flares Per Patient During 24 Weeks|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint(at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|24 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||new flares per patient||Standard Deviation|Mean
2722392|NCT01080131|Secondary|Time to the First New Gout Flare During 24 Weeks|"Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|From randomization to the end of the first extension period (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||days||95% Confidence Interval|Median
2722393|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)|Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.|||mm||Standard Error|Least Squares Mean
2722394|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||mm||Standard Error|Least Squares Mean
2722395|NCT01080131|Secondary|Pharmacokinetic Concentrations|Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.|12 weeks post-dose|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||µg/mL||Standard Deviation|Mean
2722396|NCT01080131|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||mm||Standard Error|Least Squares Mean
2722397|NCT01080131|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study|The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.|Baseline to Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||percentage of participants|||Number
2722398|NCT01080131|Secondary|SF 36 Physical Function Score at Week 12|SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2722400|NCT01080131|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)|Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||hours||95% Confidence Interval|Median
2722401|NCT01080131|Primary|Time to First New Flare: Survival Analysis During the 12 Weeks of Study|Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.|Baseline to 12 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Days||95% Confidence Interval|Median
2722402|NCT01080118|Secondary|Time to Intubation|Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.|||seconds||95% Confidence Interval|Mean
2722403|NCT01080118|Primary|Successful Endotracheal Intubation|A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.|||% successful|||Number
2722404|NCT01079988|Secondary|Patient's Global Psoriasis Assessment (PGPA)|"The PGPA consisted of a single self-explanatory item:~On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now.~Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis)."|12 weeks|One patient withdrew|||PGPA score||Standard Deviation|Mean
2722405|NCT01079988|Primary|Physician's Global Assessment (PGA) of Change Over Time (Good or Better)|"The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline:~Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%"|12 weeks||||participants|||Number
2722406|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|Per protocol (PP) population included those participants for whom primary and secondary efficacy endpoints were all measured, and who did not meet the withdrawal criteria and showed 75 percent of medication compliance.|||mmHg||Standard Deviation|Mean
2722407|NCT01079962|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 14 (follow-up visit)|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||Participants|||Number
2722408|NCT01079962|Secondary|Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12|The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||mmHg||Standard Deviation|Mean
2722409|NCT01079962|Secondary|Change From Baseline in Blood Glucose Levels at Week 12|The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2722410|NCT01079962|Secondary|Change From Baseline in Lipid Levels at Week 12|The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||Milligram/decilitre (mg/dL)||Standard Deviation|Mean
2722411|NCT01079962|Secondary|Change From Baseline in Aortic Pulse Pressure (APP) at Week 4|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline.|Baseline and Week 4|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||mmHg||Standard Deviation|Mean
2722494|NCT01079182|Secondary|Mean Participant Fatigue Score|Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Score on scale||Standard Deviation|Mean
2722413|NCT01079962|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12|Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Meters per second (m/s)||Standard Deviation|Mean
2722414|NCT01079962|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12|Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Ratio||Standard Deviation|Mean
2722415|NCT01079962|Secondary|Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12|The change in aortic BP (aortic systolic blood pressure [SBP], aortic diastolic blood pressure [DBP] and aortic mean blood pressure [BP]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||mmHg||Standard Deviation|Mean
2722416|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2722417|NCT01079949|Secondary|Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2722418|NCT01079949|Secondary|Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||pg/mL||Standard Deviation|Mean
2722419|NCT01079949|Secondary|Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||milli international unit (mIU)/mL||Standard Deviation|Mean
2722420|NCT01079949|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication.N (number of participants analyzed) signifies those participants with plasma E2 levels at r-hCG day."|||picogram/milliter (pg/mL)||Standard Deviation|Mean
2722421|NCT01079949|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||IU||Standard Deviation|Mean
2722422|NCT01079949|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day).|Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||days||Standard Deviation|Mean
2722423|NCT01079949|Secondary|Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
2722424|NCT01079949|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
2722425|NCT01079949|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]})|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||percent sacs per embryo||Standard Deviation|Mean
2722466|NCT01079598|Primary|Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.|QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
2722427|NCT01079949|Secondary|Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN|Oocytes were fertilized using ICSI technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||oocytes|||Number
2722428|NCT01079949|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||2PN oocytes|||Number
2722429|NCT01079949|Secondary|Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day|Endometrial thickness measurement was performed on the day of r-hCG administration.|r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||mm||Standard Deviation|Mean
2722430|NCT01079949|Secondary|Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||follicles||Standard Deviation|Mean
2722431|NCT01079949|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
2722432|NCT01079949|Primary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||cycles|||Number
2722433|NCT01079949|Primary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
2722434|NCT01079949|Primary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||mature oocytes|||Number
2722435|NCT01079949|Primary|Number of Oocytes Retrieved|Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||oocytes||Standard Deviation|Mean
2722436|NCT01079936|Primary|Participants With Grade 3 =/> Adverse Events|Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.|Day 90 after stem cell transplant||||participants|||Number
2722437|NCT01079936|Primary|Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II)|Dose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.|Day 30 following transplant||||participants|||Number
2722438|NCT01079936|Primary|Number of Participants With Response (CR at Day 90)|Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with <5% plasma cells. There should be < 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.|Day 90 after stem cell transplant||||participants|||Number
2722527|NCT01078909|Secondary|Change in Lipid Mediators|0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.|1, 2, 3 and 5 days post LPS administration|Lipid mediators were unable to be detected; Data were not collected.||||||
2722439|NCT01079936|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide|There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.|Assessed at 21-28 Day Cycle|Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.|||mg/day|||Number
2722440|NCT01079832|Secondary|Clinical Response Rate|Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).|at 6 months from study entry|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2722441|NCT01079832|Secondary|Quality of Life||After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.|Participant surveys were unreliably returned to investigators, making this analysis not meaningful.||||||
2722442|NCT01079832|Secondary|Median Overall Survival|Length of time patients survived at study end.|24 months|Intent to treat|||months||95% Confidence Interval|Median
2722443|NCT01079832|Secondary|Disease-free Survival|Median disease free survival|completion of study at 24 months|Intent to treat|||months||95% Confidence Interval|Median
2722444|NCT01079832|Primary|Acute Toxicity Rate|The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.|at 6 months after treatment|Intent to treat|||percentage of participants|||Number
2722445|NCT01079806|Secondary|Percentage of Participants With HbeAg Loss at Weeks 48 and 96|HBeAg Loss (NC = F and NC = M) - On Treatment through Week 96 - Year 2 Efficacy Cohort Non-Completer - Failure (NC=F): The numerator was based on participants meeting the response criteria. The denominator was based on treated participants. Participants who had missing data at the analysis week were considered failures. Non-Completer - Missing (NC=M): The numerator was based on participants meeting the response criteria. The denominator was based on participants with data at the analysis week. Participants who had missing data at the analysis week were excluded.|At 48 and 96 weeks|Participants with response rates at weeks 48 and 96 in Entecavir (ETV) and Placebo (PBO) randomized cohort|||Percentage of participants|||Number
2722446|NCT01079806|Secondary|Histological Analysis (Percentage) Among Participants With Available Liver Biopsy Data|Liver function test elevations and abnormalities on blinded and open-label ETV (the All ETV Safety Cohort). Participants who experienced elevation of alanine aminotransferase (ALT) greater than three times ETV (entecavir) baseline measure (Participants who displayed liver biopsy with ALT value greater than three times baseline.)|Between weeks 48 and 96|Randomized ETV subjects combined with PBO-randomized participants who received open-label ETV|||Percentage of participants|||Number
2722447|NCT01079806|Secondary|Percentage of Participants With HBeAg Seroconversion (Undetectable HBeAg and Presence of Anti-HBeAb) up to Week 96|On Treatment through week 96 - 2 year cohort NC = F: (The numerator was based on participants meeting the response criteria. The denominator was based on treated participants. Participants who had missing data at the analysis week were considered failures.)|up to week 96|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2722448|NCT01079806|Secondary|Percentage of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression Through Week 96|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase.|Day 1 through Week 96|All treated participants|||Percentage of participants|||Number
2722449|NCT01079806|Secondary|Percentage of Participants Who Maintained HBeAg Seroconversion at Week 96 (End of Blinded Therapy) Among Participants With HBeAg Seroconversion at Week 48|Participants who achieved HBeAg seroconversion by Week 48 and maintained seroconversion to week 96|At Week 96|participants with HBeAg seroconversion at Week 48|||Percentage of participants|||Number
2722450|NCT01079806|Secondary|Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort)|HBe seroconversion=undetectable HBe antigen and detectable anti-HBe antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 96|Randomized ETV subjects combined with PBO-randomized participants who received open-label ETV|||Percentage of participants|||Number
2722451|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; ULN=upper limit of normal; LLN=lower limit of normal. ALT, AST (*ULN): Grade 1=1.25-2; Grade 2=2.6-5; Grade 3=5.1-10; Grade 4 => 10. Bilirubin (*ULN): Grade 1 = 1.1-1.5; Grade 2=1.6-2.5; Grade 3 = 2.6-5; Grade 4= >5. Albumin (g/dL): Grade 1=3- <LLN; Grade 2=2-2.9; Grade 3= <2. Lipase (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-3; Grade 3=3.1-5; Grade 4= >5. BUN/urea (*ULN): Grade 1=1.25-<2.6; Grade 2=2.6-<5.1; Grade 3=5.1-10; Grade 4= >10. Chloride, high (mEq/L): Grade 1=113-<117; Grade 2=117-<121; Grade 3=121-125; Grade 4= >125. Potassium, low (mEq/L): Grade 1=3-3.4; Grade 2=2.5-<3; Grade 3=2-<2.5; Grade 4=<2. Potassium, high (mEq/L): : Grade 1= 5.6-<6.1; Grade 2=6.1-<6.6; Grade 3=6.6-7; Grade 4= >7. Sodium, high (mEq/L): Grade 1=146<151; Grade 2=151-<155; Grade 3=155-<160; Grade 4= >=160.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication|||participants|||Number
2722452|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. INR=international normalization ratio of prothrombin time; ULN=upper limit of normal. Hemoglobin (g/dL): Grade 1=10-10.9; Grade 2=9-9.9; Grade 3=7-8.9; Grade 4= <7. Platelets (/mm^3): Grade 1=100,000-124,999; Grade 2=50,000-99,999; Grade 3=25,000-49,999; Grade 4= <25,000. INR (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2; Grade 3=2.1-3; Grade 4= >3. WBC (/mm^3): Grade 1=2000-2500; Grade 2=1500-1999; Grade 3=1000-1499; Grade 4= <1000. Neutrophils (/mm^3): Grade 1=1000-1300; Grade 2=750-999; Grade 3=500-749; Grade 4= <500.|Day 1 through Week 48 on blinded therapy|All treated subjects|||Participants|||Number
2722453|NCT01079806|Secondary|Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase.|Day 1 through Week 48 on blinded therapy|All treated participants|||participants|||Number
2722454|NCT01079806|Secondary|Percentage of Participants Who Achieved Sustained HBeAg Seroconversion During Off-treatment Follow up Among Participants Who Achieved HBeAg Seroconversion at End of Dosing (EOD).|Participants who demonstrated HBeAg seroconversion at EOD were followed and assessed for presence of sustained HBeAg seroconversion during entire study. The study reached the end of dosing (EOD) on 22 Feb-2016.|Week 48, EOD (2 years)|Participants who achieved HBeAg seroconversion at end of treatment.|||Percentage of participants|||Number
2722455|NCT01079806|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb)|Percentage of participants in the primary cohort with HBeAg seroconversion (undetectable HBeAg and presence of anti-HBe antibodies) at week 48|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
2722456|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48|LOQ=29 IU/mL. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
2722457|NCT01079806|Secondary|Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
2722458|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
2722459|NCT01079806|Primary|Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48|Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
2722460|NCT01079741|Secondary|NY-ESO-1 Expression by IHC|Analysis of immune cell infiltration at the injection site by IHC. IHC analysis of immune cell infiltration was performed for each arm using a scoring system. 0: No expression of the marker of interest, 1: single cells or small clusters (<5 cells together) expressing marker of interest, 2: medium size clusters of cells expressing marker of interest, and 3: huge and homogeneously positive clusters of cells expressing marker of interest.|up to 52 weeks||||units on a scale||Standard Deviation|Mean
2722461|NCT01079741|Secondary|CD4+ and CD8+ Response|Cellular response evaluated for the induction of cellular T cell (CD4+ and CD8+) immunity to subcutaneous vaccination with NY-ESO-1 protein in combination with Poly-ICLC when given with or without Montanide. Number of participants with increase CD4+ and CD8+ levels.|Up to 52 weeks||||Participants|||Count of Participants
2722462|NCT01079741|Primary|Phase I, Number of Participants With SAE and DLT|Safety measured by number of Serious Adverse Events per the CTEP v4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and Dose Limiting Toxicity (DLT).|52 weeks||||Participants|||Count of Participants
2722463|NCT01079598|Secondary|Cessation of Flow Reflux Through the Perforator Vein|Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
2722464|NCT01079598|Secondary|CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)|CEAP Classification at Month 6 will be reported.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
2722528|NCT01078909|Primary|Mean Concentrations of CRP Following 5 Months of Treatment||5 months|One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%)|||mg/dL||95% Confidence Interval|Mean
2722467|NCT01079390|Primary|Cortical Thickness Changes at 5-7 Weeks Post-Treatment|All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software.|2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline|We combined low and high dose acupuncture into one group because we found there were not clinical differences between the two group.|||millimeters||Standard Deviation|Mean
2722468|NCT01079390|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment|The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.|One post-treatment measurement 5-7 weeks after baseline||||units on KOOS scale||Standard Deviation|Mean
2722469|NCT01079299|Primary|Median Time to Wound Closure at 9 Months|Median number of days for complete healing in each treatment group|9 months||||median number of days for complete heali||Standard Error|Median
2722470|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||Episodes/100 years of patient exposure|||Number
2722471|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||Episodes/100 years of patient exposure|||Number
2722472|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). FPG baseline values were missing for 6 subjects. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||mmol/L||Standard Deviation|Mean
2722473|NCT01079234|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 6 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
2722474|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2722475|NCT01079234|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2722476|NCT01079195|Secondary|Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity|The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.|6 months|This analysis used the safety analysis population, which included any participant who took at least one dose of Tarka and had at least one follow-up visit.|||Events|||Number
2722477|NCT01079195|Secondary|Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.|The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.|6 months|2122 participants were excluded from the analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).|||Percentage of participants|||Number
2722478|NCT01079195|Primary|Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End|"Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point end of study."|Baseline to 6 months/study end|2122 participants were excluded from this analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).|||mmHg||Standard Deviation|Mean
2722479|NCT01079182|Secondary|Mean Equivalent Dose of Prednisolone|The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||mg/day||Standard Deviation|Mean
2722480|NCT01079182|Secondary|Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents|Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722481|NCT01079182|Secondary|Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722482|NCT01079182|Secondary|Percentage of Participants on Adalimumab Monotherapy||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722483|NCT01079182|Secondary|Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Days||Standard Deviation|Mean
2722484|NCT01079182|Secondary|Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722485|NCT01079182|Secondary|Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Days||Standard Deviation|Mean
2722486|NCT01079182|Secondary|Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722487|NCT01079182|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks|The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722488|NCT01079182|Secondary|Percentage of Participants Achieving ASAS Partial Remission Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722489|NCT01079182|Primary|Number of Participants With Drug-Related Adverse Events (AEs)|An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.|From signing of informed consent up to 24 months|Safety analysis set: Participants who received at least one dose of adalimumab.|||Participants|||Number
2722490|NCT01079182|Secondary|Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.|At 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722491|NCT01079182|Secondary|Mean Duration of Morning Stiffness|Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||minutes||Standard Deviation|Mean
2722492|NCT01079182|Secondary|Percentage of Participants With Morning Stiffness|Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722495|NCT01079182|Secondary|Mean Global Assessment of Disease Activity Score|Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Score on scale||Standard Deviation|Mean
2722496|NCT01079182|Secondary|Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score|The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||BAS-G score||Standard Deviation|Mean
2722497|NCT01079182|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||mg/L||Standard Deviation|Mean
2722498|NCT01079182|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||mm/hour||Standard Deviation|Mean
2722499|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||BASFI score||Standard Deviation|Mean
2722500|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||BASDAI score||Standard Deviation|Mean
2722501|NCT01079182|Secondary|Percentage of Participants With Extraspinal Manifestations|Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
2722502|NCT01079182|Secondary|Mean Number of Involved Peripheral Joints|Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Joints||Standard Deviation|Mean
2722503|NCT01079143|Secondary|Incidence (Number) of Participants With Graft Losses|If a participant underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
2722504|NCT01079143|Secondary|Incidence (Number) of BPAR|A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Number of participants|||Number
2722505|NCT01079143|Secondary|Severity of BPAR|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.~Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.~Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
2722529|NCT01078909|Primary|Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment||5 months|One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%)|||pg/mL||95% Confidence Interval|Mean
2722530|NCT01078844|Primary|Clinical Global Impression-Scale(CGI-S)||12 weeks|This study was terminated prematurely and data was not collected for this outcome measure.||||||
2722900|NCT01077518|Secondary|Time to Progression in Participants With FL Per IRC|Time from randomization until disease progression|From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||Months||95% Confidence Interval|Median
2722506|NCT01079143|Secondary|Type of Biopsy Proven Acute Rejection (BPAR)|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.~Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.~Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
2722507|NCT01079143|Secondary|Treatment Failures|A treatment failure is defined as biopsy proven acute rejection (BPAR), a graft loss, a death or a loss to follow up. It was assessed between randomization and 6 and 12 months post-transplantation.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Number of Participants|||Number
2722508|NCT01079143|Secondary|Change in Urine Protein/Creatinine Ratio (Without Imputation)|One of the factors associated with EMT progression between M3 and M12 according to univariate analysis (ITT biopsies M3 & M12).|Month 3 (baseline), Month 12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||mg/mmol||Standard Deviation|Mean
2722509|NCT01079143|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR) at M12 From Baseline (M3) - ANCOVA Model|The average patient renal function was evaluated on the basis of eGFR was calculated according to the abbreviated MDRD formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).|Baseline (M3), M12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||mL/min/1.73m²||Standard Deviation|Mean
2722510|NCT01079143|Secondary|Change From Baseline (M3) in Estimated Glomerular Filtration Rate (eGFR)|"eGFR was calculated according to the abbreviated Modification of Diet in Renal Disease (MDRD) Formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).~LOCF = Last observation carried forward"|M3 (baseline) to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2722511|NCT01079143|Secondary|Incidence (Number) of Subclinical Rejections and Borderline Lesions|"Incidence of subclinical rejections and borderline lesions with regards to histological evidence of rejection with clinical findings.~Subclinical rejections: rejection without clinical symptoms which is diagnosed by chance when a graft biopsy is performed.~Clinically suspected BPAR: rejection suspected because of the presence of clinical symptoms (fever, pain, increase of creatinine) and then confirmed by the graft biopsy.~Borderline lesions: suspicious for acute T-cell mediated rejection. This category is used when no intimal arteritis is present, but there are foci of tubulitis with minor interstitial infiltration or interstitial infiltration with mild tubulitis."|M3|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
2722512|NCT01079143|Secondary|Change in EMT Score|"Change (M12 - M3) in EMT Score. Progression in EMT score is defined as an increase by >=1 of EMT score from M3 to M12.~EMT score 0 (the best): <1 EMT score 1 (the better) : 1-10% of tubular atrophy EMT score 2 : 10-25% of tubular atrophy EMT score 3 : 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||scores on a scale||Standard Deviation|Mean
2722513|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Score|"Incidence and severity of EMT score. The intensity of EMT markers expression present and detectable in the renal graft at an early stage following transplantation is known as EMT score.~EMT score 0 (the best): <1 EMT score 1 (the better): 1-10% of tubular atrophy EMT score 2: 10-25% of tubular atrophy EMT score 3: 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||participants|||Number
2722514|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Status|Incidence and severity of EMT status. EMT status was determined centrally using the graft biopsy taken at 3 months. The result was quickly obtained (within 7 to 15 days) and sent to the company in charge of randomization in order to allocate each patient to a treatment group and to provide the investigator with this information without confirming EMT status.|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Participants|||Number
2722515|NCT01079143|Secondary|Number of Participants With Progression of Renal Fibrosis Using Numerical Quantification|Comparisons according to epithelial-mesenchymal transition (EMT) profile and immunosuppressive treatment|M3 to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Participants|||Number
2722516|NCT01079143|Secondary|Change in Percentage of Interstitial Fibrosis (IF) by Numerical Quantification|Percentage of IF measured by numerical quantification. The IF percentage was transposed in grade according to the following rule: grade 0 for an IF % ≤5%, grade I for an IF % ranging from >5% to < 25%, grade II for an IF % ranging from 25 to 50%, grade III for an IF % >50%. Interstitial graft fibrosis has been identified as the primary cause of graft loss following death with a functional graft [3-5].|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Percentage of IF||Standard Deviation|Mean
2722517|NCT01079143|Secondary|Risk Factors of IF/TA Progression|"Composite factors regarding fibrosis progression at 12 months using a logistic regression model; the parameters initially considered concerned the demographic characteristics of both recipient and donor, transplantation characteristics, hypertension, diabetes, study treatments, immunosuppression, EMT, IF/TA, function at M3, the onset of acute rejection, the presence of anti-donor antibodies at M12, infections and BK virus viremia.~Arteriolar hyaline thickening is thickening of the walls of arterioles by the deposition of homogeneous pink hyaline material.~BPAR is biopsy proven acute rejection. TEM progression is the increase ≥ 1 of TEM score between Month 3 and Month 12"|M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Participants|||Number
2722518|NCT01079143|Secondary|Change in Interstitial Fibrosis/Tabular Atrophy (IF/TA) Grade|Difference (M12 - M3) in IF/TA grade. IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Number of Participants|||Number
2722519|NCT01079143|Secondary|Interstitial Fibrosis/Tabular Atrophy (IF/TA)|Incidence and severity of IF/TA according to 2005/2007 Banff classification system grades (grades l to lll). IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Number of participants|||Number
2722520|NCT01079143|Primary|Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population|"Progression of Interstitial Fibrosis/Tabular Atrophy (IF/TA) is the percentage (%) of participants with an increase >= 1 in IF/TA grade according to Banff (2005 - 2007)according to Epithelial-mesenchymal transition (EMT) profile and by treatment groups.~Grade I (the better): mild interstitial fibrosis and tubular atrophy (<25% of cortical area) Grade II : moderate interstitial fibrosis and tubular atrophy (26-50% of cortical area) Grade III (the worse) : severe interstitial fibrosis and tubular atrophy (>50% of cortical area)"|Month 3 (M3) and Month 12 (M12) post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12. The primary comparison concerned only the Certican and the Neoral EMT+ groups.|||Participants|||Number
2722521|NCT01079130|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 2 (after 1 day of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure.|||Liters||Standard Error|Least Squares Mean
2722522|NCT01079130|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 15 (after 2 weeks of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2722523|NCT01078974|Primary|Tolerability of Pomalidomide|Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy|2 years||||participants|||Number
2722524|NCT01078974|Primary|Maximum Tolerated Dose of Pomalidomide|To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.|2 years|The maximum tolerated dose was not determined due to study termination. Three participants experienced IgM flare causing them to be removed from the study early.|||mg|||Number
2722525|NCT01078922|Secondary|Overall Clinical Benefit (OCB)|"OCB = # patients with a CR + # of patients with a PR + # patients with Stable Disease (SD) divided by the number of evaluable patients CR and PR is defined in Outcome Measure #1~SD is defined as:~Failure to attain CR/PR or Progressive Disease (PD)~PET remains positive.~PD is defined as:~Any new lesion > 1.5 cm in longest axis~An increase 50% or more of previously involved sites from nadir~50% increase in SPD of more than one node or 50% increase in the longest diameter of a previously identified node that is > 1 cm in shortest axis~PET remains positive if it was positive before therapy."|Evaluated every 2 cycles (every 2 months), up to 80 weeks||||percentage of participants|||Number
2722526|NCT01078922|Primary|Overall Response (OR)|"OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients.~A CR is defined as:~Disappearance of all disease.~If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative~If the nodal masses were Variably or PET negative; they must regress to normal.~No palpable liver or spleen~Palpable nodal masses are no longer palpable~Negative bone marrow biopsy~A PR is defined as:~Regression of measurable disease and no new sites of disease.~> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required.~No increase in the size of the liver or spleen"|evaluated every 2 months up to 80 weeks|Analysis was per protocol. Patients were evaluated every 2 cycles for Overall Response, up to 80 weeks.|||percentage of participants|||Number
2722531|NCT01078805|Secondary|Physician Criteria for Initiating FORTEO Therapy|Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.|Baseline|Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics.|||participants|||Number
2722532|NCT01078805|Secondary|Percentage Change From Baseline in Bone Area at Month 24 Endpoint|Bone area is a defined region of interest of bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.|||percent change of centimeter square||Standard Error|Mean
2722533|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint|BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.|||percentage (%) change of grams (g)||Standard Error|Mean
2722534|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.|||percentage (%) change of BMD||Standard Error|Mean
2722535|NCT01078805|Secondary|Treatment Adherence|Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.|||days||Standard Deviation|Mean
2722536|NCT01078805|Secondary|Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.|||percentage change of pain score||Standard Error|Mean
2722537|NCT01078805|Secondary|Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.|||percentage change of pain score||Standard Error|Mean
2722538|NCT01078805|Secondary|Percentage of Participants With Clinical Vertebral Fractures|Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.|||Percentage of participants|||Number
2722539|NCT01078805|Primary|Percentage of Participants With Non-Vertebral Fragility Fractures|Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.|||Percentage of participants|||Number
2722540|NCT01078753|Secondary|Change in Number of Wet Nights Between Treatment Periods I and II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II.|Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)|The full analysis set.|||wet nights||95% Confidence Interval|Least Squares Mean
2722541|NCT01078753|Secondary|Change in Number of Wet Nights Between Baseline and Treatment Period I|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I.|Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).|The Full analysis set.|||wet nights||95% Confidence Interval|Least Squares Mean
2722542|NCT01078753|Primary|Change in the Number of Wet Nights Between Baseline and Treatment Period II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.|Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).|The Full Analysis Set (FAS) included all participants who received at least one dose of study treatment, satisfied all the major eligibility criteria and for whom efficacy data was obtained.|||wet nights||95% Confidence Interval|Least Squares Mean
2722575|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication added.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
2722543|NCT01078675|Secondary|Overal Treatment Adherence|Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set|||Percent of doses||Standard Deviation|Mean
2722544|NCT01078675|Primary|Single Dose PK - AUC(0-24)|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set|||ng*hr/mL||Standard Deviation|Mean
2722545|NCT01078675|Primary|Single Dose PK - Tmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set|||hr||Standard Deviation|Mean
2722546|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 24|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set|||Participants|||Number
2722547|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 12|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set|||Participants|||Number
2722548|NCT01078675|Primary|Percent Change From Baseline in Height|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Safety Population|||Percent change||Standard Deviation|Mean
2722549|NCT01078675|Secondary|Total Duration of Exposure|Total duration of exposure was calculated as [last dose date of rosuva - first dose date of rosuva + 1 day]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set|||Days||Standard Deviation|Mean
2722550|NCT01078675|Secondary|Adverse Events|Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set|||Participant|||Number
2722551|NCT01078675|Secondary|Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT)|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Intent-to-treat analysis set (LOCF) and healthy siblings|||mm||Standard Deviation|Mean
2722552|NCT01078675|Secondary|Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set (LOCF)|||Percent change||Standard Deviation|Mean
2722553|NCT01078675|Primary|Single Dose PK - Cmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours.|Single dose PK analysis set|||ng/mL||Standard Deviation|Mean
2722554|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Baseline|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set|||Participants|||Number
2722555|NCT01078675|Primary|Percent Change From Baseline in LDL-C|Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set and Per-protocol analysis set|||Percentage change||Standard Deviation|Mean
2722556|NCT01078662|Secondary|Disease Control Rate at Week 16|Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16|Full analysis set - all treated patients|||Percentage of participants||95% Confidence Interval|Number
2722557|NCT01078662|Secondary|Duration of Response|Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.|From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months|Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.|||days||Inter-Quartile Range|Median
2722558|NCT01078662|Secondary|Overall Survival Rate at 12 Months|Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.|||Percentage of participants|||Number
2722559|NCT01078662|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.|||months||Inter-Quartile Range|Median
2722591|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months||Day 0 (Baseline), 3 Months|ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint.|||mm Hg||95% Confidence Interval|Mean
2722560|NCT01078662|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.|||months||Inter-Quartile Range|Median
2722561|NCT01078662|Secondary|Objective Response Rate|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline|||Percentage of participants||95% Confidence Interval|Number
2722562|NCT01078662|Primary|Tumour Response Rate|Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients|||Percentage of participants||95% Confidence Interval|Number
2722563|NCT01078623|Secondary|Change From Baseline in Morning Peak FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1|||Liters||Standard Error|Least Squares Mean
2722564|NCT01078623|Secondary|Change From Baseline in Morning Pre-dose FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes|Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1|||Liters||Standard Error|Least Squares Mean
2722565|NCT01078623|Primary|Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1|||Liters||Standard Error|Least Squares Mean
2722566|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits.|||percentage of participants|||Number
2722567|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|12 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).|||percentage of participants|||Number
2722568|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|6 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point).|||percentage of participants|||Number
2722569|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|3 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).|||percentage of participants|||Number
2722570|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication discontinued.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
2722571|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication discontinued.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
2722572|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication discontinued.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
2722573|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication added.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
2722574|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication added.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
2722576|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|12 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).|||percentage of participants|||Number
2722577|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|6 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).|||percentage of participants|||Number
2722578|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were controlled versus uncontrolled was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|3 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).|||percentage of participants|||Number
2722579|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 12 Months||12 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).|||participants|||Number
2722580|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 6 Months||6 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).|||participants|||Number
2722581|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 3 Months||3 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).|||participants|||Number
2722582|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 12 Months|"Compliance after 12 months of treatment was derived using responses to the question How many trandolapril doses have been missed since the subject's last visit? at Visit 2, Visit 3 and Visit 4, as follows: if the response was zero at all of the Visits 2 through 4 assessments, the participant was classified as compliant after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as non-compliant after 12 months of treatment."|12 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).|||participants|||Number
2722583|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 6 Months|"Compliance after 6 months of treatment was derived using responses to the question How many trandolapril (Mavik®) doses have been missed since the subject's last visit? at both Visit 2 and Visit 3, as follows: If the response was zero at both the Visit 2 and Visit 3 assessments, participant was classified as compliant after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as non-compliant after 6 months of treatment"|6 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).|||participants|||Number
2722584|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 3 Months|"Compliance after 3 months of treatment was derived using responses to the Visit 2 question How many trandolapril (Mavik®) doses have been missed since the subject's last visit? If the response was zero, the participant was classified as compliant. If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as non-compliant."|3 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).|||participants|||Number
2722585|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12||Day 0 (Baseline), Month 12|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
2722586|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6||Day 0 (Baseline), Month 6|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
2722587|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3||Day 0 (Baseline), Month 3|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
2722588|NCT01078584|Other Pre-specified|Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts||Day 0 (Baseline)|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
2722589|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months||Day 0 (Baseline), 12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint).|||mm Hg||95% Confidence Interval|Mean
2722590|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months||Day 0 (Baseline), 6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||mm Hg||95% Confidence Interval|Mean
2722592|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|12 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
2722593|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|6 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
2722594|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|3 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
2722595|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||percentage of participants|||Number
2722596|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||percentage of participants|||Number
2722597|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy|"Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|3 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||percentage of participants|||Number
2722598|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits.|||percentage of participants|||Number
2722599|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy|"The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled."|12 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
2722600|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy|"The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled."|6 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
2722601|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy|"The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled."|3 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
2722602|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 12 Months||Baseline, 12 months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).|||mg/L||95% Confidence Interval|Mean
2722603|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 6 Months||Baseline, 6 Months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).|||mg/L||95% Confidence Interval|Mean
2722604|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 3 Months||Baseline, 3 Months|Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point).|||mg/L||95% Confidence Interval|Mean
2722605|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline,12 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).|||mL/min||95% Confidence Interval|Mean
2722606|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 6 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).|||mL/min||95% Confidence Interval|Mean
2725613|NCT01056380|Secondary|Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)||Up to 28 days|All subjects with any laboratory confirmed viral infection who took at least one dose of study medication.|||hours||Inter-Quartile Range|Median
2722607|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 3 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).|||mL/min||95% Confidence Interval|Mean
2722608|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|12 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).|||percentage of participants|||Number
2722609|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|6 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).|||percentage of participants|||Number
2722610|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|3 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).|||percentage of participants|||Number
2722611|NCT01078571|Secondary|Radiological Evaluation of Rheumatoid Arthritis (RA).|Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.|Baseline and 12 months|This analysis was conducted in the intent-to-treat population (591 participants total).|||Participant|||Number
2722612|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.|Baseline and 12 Months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.|||Percentage change||Standard Deviation|Mean
2722613|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).|Baseline and 12 months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.|||Units on a scale||Standard Deviation|Mean
2722614|NCT01078571|Secondary|Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.|The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.|Baseline, 1, 4, 6, and 12 months|This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.|||Joints||Standard Deviation|Mean
2722615|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented."|Baseline and 12 months|Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.|||Percentage reduction||Standard Deviation|Mean
2722616|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented."|Baseline and 12 months|Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.|||Units on a scale||Standard Deviation|Mean
2722665|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
2722617|NCT01078571|Primary|Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment|The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.|Baseline, 1, 4, 6, and 12 months|This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).|||Participants|||Number
2722618|NCT01078558|Primary|Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.|up to 60 months||||Participants|||Count of Participants
2722619|NCT01078558|Primary|Change From Baseline in BASDAI Over Time: AS Participants|BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms.|Baseline, Months 3, 6, 12, 24, 60|All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.|||score on a scale||Standard Deviation|Mean
2722620|NCT01078558|Primary|Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants|Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.|Baseline, Months 3, 6, 12, 24, 60|All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.|||units on a scale||Standard Deviation|Mean
2722621|NCT01078558|Primary|Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants|Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.|Baseline, Months 3, 6, 12, 24, 60|All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.|||units on a scale||Standard Deviation|Mean
2722622|NCT01078558|Primary|BSA With PsA Over Time: PsA Participants||Baseline, Months 3, 6, 12, 24, 60|All PsA participants with a Baseline and post-baseline assessment at given time point.|||Participants|||Count of Participants
2722623|NCT01078558|Primary|DAS28 Category Over Time: RA Participants|The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Months 3, 6, 12, 24, 60|All RA participants with a Baseline and post-baseline assessment at given time point.|||Participants|||Count of Participants
2722624|NCT01078558|Primary|Change From Baseline in DAS28 Over Time: RA Participants|The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Months 3, 6, 12, 24, 60|All RA participants with a Baseline and post-baseline assessment at given time point.|||score on a scale||Standard Deviation|Mean
2722625|NCT01078558|Primary|Physical Function: Change From Baseline in HAQ% Over Time|The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement.|Baseline, Months 3, 6, 12, 24, 60|All participants with a Baseline and post-baseline assessment at given time point.|||percentage of maximum HAQ score||Standard Deviation|Mean
2722626|NCT01078558|Primary|Inflammatory Parameter: Change From Baseline in ESR Over Time||Baseline, Months 3, 6, 12, 24, 60|All participants with a Baseline and post-baseline assessment at given time point.|||mm/hour||Standard Deviation|Mean
2722627|NCT01078558|Primary|Inflammatory Parameter: Change From Baseline in CRP Over Time||Baseline, Months 3, 6, 12, 24, 60|All participants with a Baseline and post-baseline assessment at given time point.|||mg/dL||Standard Deviation|Mean
2722628|NCT01078558|Primary|Change From Baseline in Swollen Joints Over Time|A total of 28 joints were assessed for swelling.|Baseline, Months 3, 6, 12, 24, 60|All participants with a Baseline and post-baseline assessment at given time point.|||swollen joints||Standard Deviation|Mean
2722629|NCT01078558|Primary|Change From Baseline in Tender Joints Over Time|A total of 28 joints were assessed for tenderness.|Baseline, Months 3, 6, 12, 24, 60|All participants with a Baseline and post-baseline assessment at given time point.|||tender joints||Standard Deviation|Mean
2722630|NCT01078558|Primary|Change From Baseline in Physician's Assessment of Disease Activity Over Time|Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.|Baseline, Months 3, 6, 12, 24, 60|All participants with a Baseline and post-baseline assessment at given time point.|||units on a scale||Standard Deviation|Mean
2722631|NCT01078545|Secondary|Reported Adverse Events/Serious Adverse Events|Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.|||Participants|||Number
2722632|NCT01078545|Secondary|Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.|Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.|||Units on a scale||Full Range|Median
2722633|NCT01078545|Secondary|Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.|Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline|Analysis conducted in the intent-to-treat population.|||Percentage of participants|||Number
2722634|NCT01078545|Secondary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.|||units on a scale||Standard Deviation|Mean
2722635|NCT01078545|Primary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.|||units on a scale||Standard Deviation|Mean
2722636|NCT01078454|Primary|Proportion of Patients With Hematologic Overall Response (Partial Response [PR]+ Very Good PR [VGPR]+ Amyloid Complete Response [ACR]+ Stringent Complete Response [sCR]) After 3 Months (3 Cycles) of Therapy|sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), <5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein <100 mg/24 hr if baseline serum measurable; (4) urine M-component <100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90% drop in the difference between involved and uninvolved FLC levels if only FLC measurable PR: (1) ≥50% drop of serum M-protein and 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline serum/urine measurable; or (2) ≥50% drop of serum M-protein if only serum measurable at baseline; or (3) 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline urine measurable; or (4) ≥ 50% drop in the difference between involved and uninvolved FLC if only FLC measu|Assessed at 3 months|All enrolled patients are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
2722637|NCT01078441|Primary|One-year Survival in Patients Treated With This Regimen.|Proportion of patients who are still alive at 1 year after registration.|Assessed at 1 year|All eligible and treated patients are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
2722638|NCT01078402|Secondary|Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.|From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||participants|||Number
2722639|NCT01078402|Secondary|Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy|Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.|From first treatment until study discontinuation, up to 13 months.|Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||weeks||Standard Deviation|Mean
2722640|NCT01078402|Secondary|Compliance With the Humira Administration Schedule at Month 13 (End of Study)|Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.|Month 13|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||participants|||Number
2723766|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mm Hg||Standard Deviation|Mean
2722641|NCT01078402|Secondary|Participant Acceptability of Self-injection at Month 13 (End of Study)|Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.|13 months|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||percentage of participants|||Number
2722642|NCT01078402|Secondary|Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy|HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline, 4, 7 and 13 months|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.|||units on a scale||Standard Deviation|Mean
2722643|NCT01078402|Primary|Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS|BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.|||participants|||Number
2722644|NCT01078402|Primary|Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA|DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.|||participants|||Number
2722645|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
2722646|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
2722647|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
2722666|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
2722648|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
2722649|NCT01078389|Primary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis.|||score on a scale||Standard Deviation|Mean
2722650|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||L/hr||Standard Deviation|Mean
2722651|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||L/hr||Standard Deviation|Mean
2722652|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||percent||Standard Deviation|Mean
2722653|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||percent||Standard Deviation|Mean
2722654|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||mg||Standard Deviation|Mean
2722655|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||mg||Standard Deviation|Mean
2722656|NCT01078376|Primary|Apparent Oral Clearance (CL/F) for TAK-536|CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||L/hr||Standard Deviation|Mean
2722657|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Standard Deviation|Mean
2722658|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Standard Deviation|Mean
2722659|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Full Range|Median
2722660|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Full Range|Median
2722661|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng/mL||Standard Deviation|Mean
2722662|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng/mL||Standard Deviation|Mean
2722663|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
2722664|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
2722667|NCT01078363|Secondary|Index of Microcirculatory Resistance at One Year Post Heart Transplant|The index of microcirculatory resistance (IMR) is a pressure-temperature sensor guidewire-based measurement, performed during cardiac catheterization, of the minimum microcirculatory resistance in a specific coronary artery. The IMR provides a quantitative measure of coronary microvasculature status.|one year|Only a subset of participants (adult patients enrolled at Stanford University) underwent index of microcirculatory resistance assessment.|||mmHg x seconds||Standard Deviation|Mean
2722668|NCT01078363|Secondary|Fractional Flow Reserve (FFR) at One Year Post Transplant|FFR is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia). It is defined as the ratio of the distal coronary pressure to the proximal coronary pressure.|at one year post Transplant|Only a subset of participants (adult patients enrolled at Stanford University) underwent fractional flow reserve assessment.|||Ratio||Standard Deviation|Mean
2722669|NCT01078363|Secondary|The Percentage of Endothelial Progenitor Cells ( EPC) in Peripheral Blood in Patients One Year After Transplant|The determination of the percentage of EPC in peripheral blood involved surface staining peripheral blood mononuclear cells (PBMCs) with appropriate fluorescently-labeled antibodies to delineate EPCs from other blood cells, followed by analysis by conventional flow cytometry.|at one year|Not all blood samples obtained were adequate for EPC determination which explains the discrepancy in number of participants analyzed.|||percentage of EPC||Standard Deviation|Mean
2722670|NCT01078363|Secondary|ADMA Level at One Year Post Transplant|asymmetric dimethylarginine (ADMA), is an inhibitor of endothelial nitric oxide synthase which is a primary regulator of endothelial function.|1 year post Transplant|Blood samples were not acquired in all participants which accounts for the discrepancy in number of participants analyzed.|||micromole||Standard Deviation|Mean
2722671|NCT01078363|Secondary|Percentage of Participants With ≥20% Coronary Artery Diameter Reduction After Acetylcholine|The percent change in diameter of the left anterior descending artery was measured by quantitative angiography after acetylcholine and compared to baseline angiography. The percentage of participants who had ≥20% coronary artery diameter reduction after acetylcholine at one year is presented.|At Baseline and 1 Year|Only a subset of participants (those adult patients enrolled at Stanford University) underwent the acetylcholine measurements.|||percentage of participants|||Number
2722672|NCT01078363|Primary|Cardiac Allograft Vasculopathy(CAV) Defined as Change in IVUS-assessed Plaque Volume From Baseline to One Year|also called transplant coronary artery disease or cardiac transplant vasculopathy defined as coronary artery stenosis(narrowing) ranging from 30 to 70 percent by coronary angiography. Measured in this study as change in IVUS-assessed Plaque Volume from baseline to one year.|Baseline and 1 Year||||mm3/mm||Standard Deviation|Mean
2722673|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4)(Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.|||participants|||Number
2722674|NCT01078298|Other Pre-specified|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score|The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||Units on a scale||Standard Deviation|Mean
2722675|NCT01078298|Other Pre-specified|Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||Units on a scale||Standard Deviation|Mean
2722676|NCT01078298|Other Pre-specified|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||Units on a scale||Standard Deviation|Mean
2722677|NCT01078298|Other Pre-specified|Number of Participants With Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specific categories for each arm group.|||participants|||Number
2722678|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2722679|NCT01078298|Other Pre-specified|Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)|Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.|Baseline up to Week 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.|||participants|||Number
2722680|NCT01078298|Secondary|Number of Participants With 4-Week Point Prevalence (PP) of Abstinence|Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||participants|||Number
2722681|NCT01078298|Secondary|Number of Participants With 7-day Point Prevalence (PP) of Abstinence|Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Weeks 12, 24, 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||participants|||Number
2722682|NCT01078298|Secondary|Percentage of Participants With Continuous Abstinence Rate (CAR)|Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 9 through Week 24, Week 9 through Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||Percentage of participants|||Number
2722683|NCT01078298|Primary|Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)|"Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm)."|Week 9 through Week 12|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||Percentage of participants|||Number
2722684|NCT01078246|Secondary|Incidence of All-cause Mortality|All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates. Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722685|NCT01078246|Secondary|Incidence of Clinically Important Cardiovascular Events|Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes. The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g. percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722686|NCT01078246|Primary|Incidence of Lipodystrophy|Lipodystrophy (e.g. lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g. sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722687|NCT01078246|Primary|Incidence of Clinically Important Muscle Events|Significant muscle events (e.g. rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase. The number of muscle events did not meet the threshold for statistical analysis per protocol. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722688|NCT01078246|Primary|Incidence of Clinically Important Skin Events|Significant skin events (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications. Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g. prednisone) administration. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722689|NCT01078246|Primary|Incidence of Clinically Important Hepatic Events|Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations. Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722690|NCT01078246|Primary|Incidence of AIDS-defining and Non-AIDS-defining Malignancy|All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries. The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g. cutaneous Kaposi's sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
2722691|NCT01078233|Primary|Incidence of All-Cause Mortality|All participant deaths were recorded|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
2722692|NCT01078233|Primary|Incidence of Lipodystrophy|Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
2722693|NCT01078233|Primary|Incidence of Clinically Important Hepatic Events|Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
2722694|NCT01078233|Primary|Incidence of Malignancy|All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
2722695|NCT01078220|Primary|Incidence Rate of Cellulitis|"Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a rule out diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study."|Within 14 days and within 60 days immediately after each vaccination||||Rate per 1000 person years|||Number
2722696|NCT01078220|Secondary|Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil|"Autoimmune cases were defined as newly diagnosed cases within 6 months after any~dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest."|within 6 months immediately after each vaccination|Number of females with at least 12 months' membership at a MCO prior to Gardasil.|||Number of autoimmune cases|||Number
2722697|NCT01078220|Secondary|Number of Miscarriages Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to pregnancy resolution|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.|||Number of miscarriages|||Number
2722698|NCT01078220|Secondary|Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to 6 months after birth|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.|||Number of congenital anomalies|||Number
2722699|NCT01078220|Primary|Incidence Rate of Syncope|"Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a rule out diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study."|On day of each vaccination||||Rate per 1000 person years|||Number
2722700|NCT01078207|Secondary|Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.|The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.|12 hours after discharge form the recovery room|All patients with a positive repetitive reduction in nasal airflow.|||participants|||Number
2722701|NCT01078207|Primary|Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.|Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects|12 hour after released from the recovery room|All patients with complete data were analyzed.|||participants|||Number
2722702|NCT01078168|Primary|Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline|Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.|baseline and 4 weeks (visit 3)|All patients were included with successful punctation at V1 and V3. For one Acitretin-treated patient not punctation at V3 was obtained (resulting n of 10).|||fold change (Visit 3/background)||Standard Deviation|Mean
2722703|NCT01078155|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24|ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||mm/1 hour||Standard Deviation|Mean
2722704|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24|Subject's Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||units on a scale||Standard Deviation|Mean
2722705|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Subject's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||units on a scale||Standard Deviation|Mean
2722706|NCT01078155|Primary|Tender Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||joints||Standard Deviation|Mean
2722707|NCT01078155|Primary|Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24|"Participant-reported the existence and duration of morning stiffness, defined as morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||minutes||Standard Deviation|Mean
2722708|NCT01078155|Primary|Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.|||µg/L||Standard Deviation|Mean
2722709|NCT01078155|Secondary|Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Physician's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points.|||units on a scale||Standard Deviation|Mean
2722710|NCT01078155|Secondary|Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24|Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||units on a scale||Standard Deviation|Mean
2722711|NCT01078155|Secondary|Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||joints||Standard Deviation|Mean
2722712|NCT01078155|Primary|Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.|||ng/mL||Standard Deviation|Mean
2722713|NCT01078155|Primary|Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.|||µg/L||Standard Deviation|Mean
2722727|NCT01078090|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||cm||Standard Deviation|Mean
2722714|NCT01078155|Primary|Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24|T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||standard deviations||Standard Deviation|Mean
2722715|NCT01078155|Primary|Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24|BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||g/cm^2||Standard Deviation|Mean
2722716|NCT01078116|Primary|Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)|The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).|12 months|Cost-utility analysis is based on the 76 participants who completed the study through 12 months.|||Euros|||Number
2722717|NCT01078116|Primary|Health Related Quality of Life (Medical Outcome Study Short Form 36)|Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.|||Units on a scale||Standard Deviation|Mean
2722718|NCT01078116|Primary|Health Related Quality of Life (Health Assessment Questionnaire)|Health Assessment Questionnaire (HAQ) is designed to assess patients' abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.|||units on a scale||Standard Deviation|Mean
2722719|NCT01078116|Primary|Health Related Quality of Life (European Quality of Life 5 Dimensions)|European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.|||Units on a scale||Standard Deviation|Mean
2722720|NCT01078116|Primary|Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment|Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.|||Euros||Standard Deviation|Mean
2722721|NCT01078090|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2722722|NCT01078090|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)|||percentage of participants|||Number
2722723|NCT01078090|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)|||days||Standard Deviation|Mean
2722724|NCT01078090|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 6, 18, 24, and 30|Full analysis set (FAS) participants with available data at each time point.|||percentage of participants|||Number
2722725|NCT01078090|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||cm||Standard Deviation|Mean
2722726|NCT01078090|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||cm||Standard Deviation|Mean
2722728|NCT01078090|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
2722729|NCT01078090|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||swollen joints||Standard Deviation|Mean
2722730|NCT01078090|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||tender joints||Standard Deviation|Mean
2722731|NCT01078090|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||mg/L||Standard Deviation|Mean
2722732|NCT01078090|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||mm/hour||Standard Deviation|Mean
2722733|NCT01078090|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.~The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set (FAS) participants with available data at each time point.|||percentage of participants|||Number
2722734|NCT01078090|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.~The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2722735|NCT01078090|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2722736|NCT01078090|Primary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.~A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
2722737|NCT01077973|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2722738|NCT01077973|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.|||Percentage of participants|||Number
2722740|NCT01077973|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2722741|NCT01077973|Secondary|Cumulative Percentage of Participants With Meaningful Relief|"Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
2722742|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722743|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722744|NCT01077973|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722745|NCT01077973|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722746|NCT01077973|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722747|NCT01077973|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722748|NCT01077973|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
2722749|NCT01077973|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
2722750|NCT01077973|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
2722751|NCT01077973|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 3 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
2722752|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||mg/dL||Standard Deviation|Mean
2722753|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||mg/dL||Standard Deviation|Mean
2722754|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin|Oral glucose tolerance testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||mcIU/mL||Standard Deviation|Mean
2722755|NCT01077960|Secondary|Change From Baseline to Week 12 in Insulin-like Growth Factor I|Circulating levels of IGF-I|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||ng/mL||Standard Deviation|Mean
2722756|NCT01077960|Secondary|Change From Baseline to Week 12 in Waist Circumference|Measured by anthropometry|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||cm||Standard Deviation|Mean
2722757|NCT01077960|Primary|Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan||baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||kg||Standard Deviation|Mean
2722758|NCT01077921|Secondary|Overall Change of Diastolic Blood Pressure Levels|Overall change of Diastolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||mmHg||Inter-Quartile Range|Median
2722759|NCT01077921|Secondary|Overall Change of Systolic Blood Pressure Levels|Overall change of Systolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||mmHg||Inter-Quartile Range|Median
2722760|NCT01077921|Secondary|Overall Change of Oxygen Saturation (02Sat) Levels|Overall change of Oxygen Saturation (02Sat) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||percentage of oxygen saturation||Inter-Quartile Range|Median
2722761|NCT01077921|Secondary|Overall Change of Lactate Dehydrogenase (LDH) Levels|Overall change of LDH levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||IU/L||Inter-Quartile Range|Median
2722762|NCT01077921|Secondary|Overall Change of Hematocrit (Hct) Levels|Overall change of Hematocrit (Hct) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||percentage of red blood cells||Inter-Quartile Range|Median
2722763|NCT01077921|Secondary|Overall Change of Hemoglobin (Hgb) Levels|Overall change of Hemoglobin (Hgb) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||gm/dL||Inter-Quartile Range|Median
2722764|NCT01077921|Secondary|Overall Change of Plasma Levels of sVCAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sVCAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 or week 8 to 14)|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
2722765|NCT01077921|Secondary|Overall Change of Plasma Levels of sICAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sICAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14)|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
2722766|NCT01077921|Secondary|Overall Change of Plasma Levels of sP-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sP-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and weeks 8 to 14).|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
2722767|NCT01077921|Primary|SS RBC Adhesion (Epi -3d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 3 dyne/cm2|Week 0 to 6 and week 8 to 14||||Percentage of total RBC||Standard Deviation|Mean
2722768|NCT01077921|Primary|SS RBC Adhesion (Epi -2d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 2 dyne/cm2|Week 0 to 6 and week 8 to 14||||Percentage of total RBC||Standard Deviation|Mean
2722769|NCT01077921|Secondary|Overall Change of Plasma Levels of sE-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sE-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14).|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
2723231|NCT01075204|Secondary|Sputum Status at End of Study|Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.|10 days|Enrolled patients with sputum data available.|||participants|||Number
2722770|NCT01077921|Primary|SS RBC Adhesion (Epi -1d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2|Week 0 to 6 and week 8 to 14||||Percentage of total RBC||Standard Deviation|Mean
2722771|NCT01077856|Secondary|Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status|The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
2722772|NCT01077856|Secondary|Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status|The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
2722773|NCT01077856|Secondary|Incidence of Cervical Cancer by Gardasil Vaccination Status|The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
2722774|NCT01077856|Secondary|Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status|The incidence of CIN by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
2722775|NCT01077856|Primary|Percentage of Live Born Babies With a Major Congenital Anomaly|The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.|Up to 5 years after Gardasil licensure (2007 to 2011)|The analysis population represents the babies born to participating mothers, instead of female participants, because the number of babies represents the denominator for the percentage calculation, not female participants (i.e., mothers)|||Percentage of babies with a MCA|||Number
2722776|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
2722777|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
2722778|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
2722779|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
2722780|NCT01077856|Primary|Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors|The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.||||||
2722781|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722782|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722783|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722784|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722785|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722786|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722856|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator|Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Percentage of lymphocytes in the BM||Standard Deviation|Mean
2722787|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722788|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722789|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722790|NCT01077856|Primary|Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
2722791|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722792|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722809|NCT01077739|Secondary|Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression|Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.|Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months|ITT Population. Number (n) equals (=) number of participants assessed for the given parameter at the specified visit.|||pg/mL||Standard Deviation|Geometric Mean
2722793|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722794|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women >26 years of age were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of women >26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722795|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722796|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722797|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722798|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722854|NCT01077622|Secondary|Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of platelets.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722799|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
2722800|NCT01077830|Primary|Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort|Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.|up to 21 Months after the end of the SEAS (base) study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.|||per 100 participant-years||95% Confidence Interval|Number
2722801|NCT01077830|Secondary|Crude Rate of Death Due to Cancer - Follow-up Primary Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.|up to 21 Months after the end of the base study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.|||per 100 participant-years||95% Confidence Interval|Number
2722802|NCT01077830|Secondary|Crude Rate of Death (Any Cause) - Follow-up Total Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.|up to 21 Months after the end of the base study|Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study.|||per 100 participant-years||95% Confidence Interval|Number
2722803|NCT01077817|Primary|Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)|To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used.|Up to approximately 7.3 years of follow-up|Inception Cohort came from the Overall Study Population beginning treatment with an osteoporosis study drug (initiators, 78,630 women) and 300,610 matched control women, who did not receive study drug (noninitiators). Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.|||Number of cases per 100,0000 woman-years|||Number
2722804|NCT01077817|Primary|Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)|To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.|Exposure to study drug at least 720 days before disease onset|Case-Cohort analysis population came from the Overall Study Population and comprised 929 women with esophageal cancer (cases) and a Comparison Sample of 338,911 matched control women. Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.|||Percentage of participants|||Number
2722805|NCT01077804|Secondary|Incidence Rate of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed.|From 6 weeks to 168 months (14 years) post vaccination||||Rate per 1000 person years||95% Confidence Interval|Number
2722806|NCT01077804|Primary|Incidence Rate of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination||||Rate per 1000 person years||95% Confidence Interval|Number
2722807|NCT01077804|Primary|Number of Participants With an Occurrence of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination||||Participants|||Number
2722810|NCT01077739|Secondary|Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)|"Percentage of participants with an overall response of CR or PR according to RECIST criteria.~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population; only participants with RECIST evaluations were included in the analysis.|||percentage of participants|||Number
2722811|NCT01077739|Secondary|PFS From the Start of First-Line Therapy|PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population.|||months||95% Confidence Interval|Median
2722812|NCT01077739|Primary|Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression|PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population|||months||95% Confidence Interval|Median
2722813|NCT01077713|Secondary|Duration of Response (DoR)|DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set.|||months||95% Confidence Interval|Median
2722814|NCT01077713|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set|||percentage of participants||95% Confidence Interval|Number
2722815|NCT01077713|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set|||percentage of participants||95% Confidence Interval|Number
2722816|NCT01077713|Secondary|Percentage of Participants by Best Overall Response|Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set|||percentage of participants||95% Confidence Interval|Number
2722817|NCT01077713|Secondary|Overall Survival (OS)|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization to death or end of the study (up to 53 months)|ITT set|||months||95% Confidence Interval|Median
2722818|NCT01077713|Secondary|Percentage of Participants Who Died||From randomization to death or end of the study (up to 53 months)|ITT set|||percentage of participants|||Number
2722819|NCT01077713|Secondary|Percentage of Participants Alive at 12 Months After Randomization||1 year|ITT set|||percentage of participants||95% Confidence Interval|Number
2722820|NCT01077713|Secondary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set|||months||95% Confidence Interval|Median
2722821|NCT01077713|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set|||percentage of participants|||Number
2722822|NCT01077713|Primary|Percentage of Participants Alive and Without Progressive Disease at Month 6|Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.|Month 6|Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.|||percentage of participants||95% Confidence Interval|Number
2722823|NCT01077622|Other Pre-specified|Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.|Weeks 36 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Kilo units per liter (KU/L)||Standard Deviation|Mean
2722824|NCT01077622|Secondary|Mean Residence Time (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr||95% Confidence Interval|Geometric Mean
2722825|NCT01077622|Secondary|Volume of Distribution at Steady State (Vss) for Ofatumumab|Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||mL||95% Confidence Interval|Geometric Mean
2722826|NCT01077622|Secondary|Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||mL||95% Confidence Interval|Geometric Mean
2722827|NCT01077622|Secondary|Clearance (CL) of Ofatumumab From Plasma|CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||mL/hr||95% Confidence Interval|Geometric Mean
2722828|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
2722829|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24|Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 24|PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
2722830|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7|Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 7|PK Parameter Population|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
2722831|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab|AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
2722832|NCT01077622|Secondary|Half-life (t1/2) of Ofatumumab|t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr||95% Confidence Interval|Geometric Mean
2722833|NCT01077622|Secondary|Time to Reach Cmax (Tmax) Following Ofatumumab Administration|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr||Full Range|Median
2722834|NCT01077622|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Weeks 7 and 24|PK Parameter Population|||mcg/mL||95% Confidence Interval|Geometric Mean
2722835|NCT01077622|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Micrograms per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2722836|NCT01077622|Secondary|Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
2722837|NCT01077622|Secondary|Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48|HAHA are indicators of immunogenicity to ofatumumab.|Screening; Weeks 24 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
2722838|NCT01077622|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.|Baseline and Weeks 8, 24, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||g/L||Standard Deviation|Mean
2722839|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks|Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
2722840|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks|Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
2722855|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of total neutrophils.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722841|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks|Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
2722842|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks|Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
2722843|NCT01077622|Secondary|Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda|Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Ratio of Ig kappa/Ig lambda||Standard Deviation|Mean
2722844|NCT01077622|Secondary|Number of Peripheral Blood CD23+ CD5+ Cells|CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722845|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD5+ Cells|CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722846|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD5+ Cells|CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722847|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD23+ Cells|CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722848|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD23+ Cells|CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722849|NCT01077622|Secondary|Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells|CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722850|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC|SERC assessed total neutrophils based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722851|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||percentage of lymphocytes in BM||Standard Deviation|Mean
2722852|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
2722853|NCT01077622|Secondary|Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC|SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Percentage of bone marrow infiltration||Standard Deviation|Mean
2723767|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium-phosphorus Product||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mg^2/dL^2||Standard Error|Mean
2722857|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of lymphocytes.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Giga (10^9) per liter (GI/L)||Standard Deviation|Mean
2722858|NCT01077622|Secondary|Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of hemoglobin.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2722859|NCT01077622|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC|Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.|Up to Week 48|All Subjects Population: only those participants who received CLL therapy were evaluated.|||Weeks||95% Confidence Interval|Median
2722860|NCT01077622|Secondary|Time to Response as Assessed by a SERC|Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.|||Weeks||95% Confidence Interval|Median
2722861|NCT01077622|Secondary|Overall Survival|Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.|Up to Week 48|All Subjects Population|||Weeks||95% Confidence Interval|Median
2722862|NCT01077622|Secondary|Duration of Response as Assessed by a SERC|Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.|||Weeks||95% Confidence Interval|Median
2722863|NCT01077622|Secondary|Progression-free Survival (PFS) as Assessed by a SERC|PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).|Up to Week 48|All Subjects Population: only those participants who progressed or died during the study were evaluated.|||Weeks||95% Confidence Interval|Median
2722864|NCT01077622|Primary|Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator|Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils >=1.5*10^9/liter (L), platelets >100*10^9/L, hemoglobin >11.0 grams/deciliter, lymphocytes (LC) <4.0*10^9/L, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.|Up to Week 48|All Subjects Population|||Percentage of participants|||Number
2722865|NCT01077622|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) >=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as >= G3 until the next day); and any of following: >= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).|Up to Week 8|All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.|||participants|||Number
2722866|NCT01077596|Secondary|Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with prostate cancer who were new antidepressant users.|||participants|||Number
2722867|NCT01077596|Secondary|Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with breast cancer who were new antidepressant users.|||participants|||Number
2722868|NCT01077596|Secondary|Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with uterine cancer who were new antidepressant users.|||participants|||Number
2722891|NCT01077518|Secondary|Reduction in Tumor Size|Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan.|baseline, post-baseline (up to 55 months)|ITT: The ITT population included subjects who were randomized in the study.|||mm^2||Standard Deviation|Mean
2722869|NCT01077596|Secondary|Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with bladder cancer who were new antidepressant users.|||participants|||Number
2722870|NCT01077596|Secondary|Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with lung cancer who were new antidepressant users.|||participants|||Number
2722871|NCT01077596|Secondary|Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with colorectal cancer who were new antidepressant users.|||participants|||Number
2722872|NCT01077596|Primary|Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant|The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 - December 31, 2006|Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users|||participants|||Number
2722873|NCT01077544|Secondary|Efficacy Endpoints for Ph+ ALL Patients|Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.|||Participants|||Number
2722874|NCT01077544|Secondary|Number of Ph+ CML Participants With Major Molecular Response (MMR)|The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.|||Participants|||Number
2722875|NCT01077544|Secondary|Number of Ph+ CML Participants With Cytogenic Response|Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is > 0% to 35%, minor cytogenetic response (mCyR) is > 35% to 65%, minimal response is > 65% to 95% and no response is > 95% Ph+ metaphases in the BM.|minimum of 12 cycles (28 days per cycle)|FAS consist of all patients (pts) who passed screening & are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline & discontinued study prior to subsequent cytogenetic assessment. This pt doesn’t appear in any cytogenic response category.|||Participants|||Number
2722876|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: Cmin|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose.|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2722877|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||L/h/m^2)||Geometric Coefficient of Variation|Geometric Mean
2722878|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: AUCss|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2722879|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2722880|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2722881|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Tmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||h||Full Range|Median
2722882|NCT01077544|Secondary|Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)|A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count < 10 × 109/L; platelet < 450 × 109/L; basophils < 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes < 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.|||Participants|||Number
2722883|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Cmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2722884|NCT01077518|Secondary|Human Anti-chimeric Antibodies (HACA) Over Time|The number of participants with positive and negative baseline HACA results|At Baseline and Cycle 1 day 1|Safety: The Safety population included all subjects who received at least one dose of a study drug|||Participants|||Number
2722885|NCT01077518|Secondary|B-cell Monitoring (CD19+, CD20+)|The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery.|C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days|ITT: The ITT population included subjects who were randomized in the study.|||percentage change from baseline||Standard Deviation|Mean
2722886|NCT01077518|Secondary|Plasma Ofatumumab Concentrations|Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time.|C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up|Pharmacokinetic Population: The Pharmacokinetic Population included all subjects who provided at least one evaluable PK concentration|||ug/mL||Standard Deviation|Mean
2722887|NCT01077518|Secondary|Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)|at scheduled visits for actual values as well as for change from baseline|Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days|Safety: The Safety population included all subjects who received at least one dose of a study drug (Ofa+benda arm only).|||g/L||Standard Deviation|Mean
2722888|NCT01077518|Secondary|Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine|ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.|From randomization until the 217th PFS event occurred, up to about 67.8 months|ITT: The ITT population included subjects who were randomized in the study.|||Percentage of participants|||Number
2722889|NCT01077518|Secondary|Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)|A summary by responders and non-responders|From randomization up to about 67.5 months|Safety: The Safety population included all subjects who received at least one dose of a study drug. Per protocol, HAHA was only collected for subjects in the Ofa+benda arm.|||Participants|||Number
2722890|NCT01077518|Secondary|Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status|"This is the number of participants with change in ECOG status. Change is measured categorically by Improvement, deterioration and No change. Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead"|administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|ITT: The ITT population included subjects who were randomized in the study.|||participants|||Number
2722892|NCT01077518|Secondary|PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)|The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions|administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||scores on a scale||Standard Deviation|Mean
2722893|NCT01077518|Secondary|PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)|The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions|administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|ITT: The ITT population included subjects who were randomized in the study.|||scores on a scale||Standard Deviation|Mean
2722894|NCT01077518|Secondary|PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D|"The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)"|administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||scores on a scale||Standard Deviation|Mean
2722895|NCT01077518|Secondary|PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D|"The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)"|administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|ITT: The ITT population included subjects who were randomized in the study.|||scores on a scale||Standard Deviation|Mean
2722896|NCT01077518|Secondary|PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym|The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day|administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||scores on a scale||Standard Deviation|Mean
2722897|NCT01077518|Secondary|PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym|The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day|administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days|ITT: The ITT population included subjects who were randomized in the study.|||scores on a scale||Standard Deviation|Mean
2722898|NCT01077518|Secondary|Time to Next Therapy in Participants With FL Per IRC|Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types|from randomization date to the date of receiving the next line treatment or death, up to 67.5 months|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||Months||95% Confidence Interval|Median
2722899|NCT01077518|Secondary|Time to Next Therapy in All Participants Per IRC|Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types.|from randomization date to the date of receiving the next line treatment or death, up to 67.5 months|ITT: The ITT population included subjects who were randomized in the study.|||Months||95% Confidence Interval|Median
2722901|NCT01077518|Secondary|Time to Progression in All Participants Per IRC|Time from randomization until disease progression|From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months|ITT: The ITT population included subjects who were randomized in the study.|||Months||95% Confidence Interval|Median
2722902|NCT01077518|Secondary|Duration of Response in Participants With FL Per IRC|Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.|time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2722903|NCT01077518|Secondary|Duration of Response in All Participants Per IRC|Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.|time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months|ITT: The ITT population included subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2722904|NCT01077518|Secondary|Time to Response in Participants With FL Per IRC|Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.|From randomization to up to 67.5 months|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||Months||95% Confidence Interval|Median
2722905|NCT01077518|Secondary|Time to Response in All Participants Per IRC|Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.|From randomization to up to 67.5 months|ITT: The ITT population included subjects who were randomized in the study.|||Months||95% Confidence Interval|Median
2722906|NCT01077518|Secondary|Overall Survival (OS) in Participants With FL|The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.|From randomization up to about 89 months|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2722907|NCT01077518|Secondary|Overall Survival (OS) in All Participants|The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.|From randomization up to about 89 months|ITT: The ITT population included subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2722908|NCT01077518|Secondary|Overall Response Rate (ORR) in Participants With FL Per IRC|ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.|From randomization until the 217th PFS event occurred, up to about 67.5 months|Subjects in ITT with FL. ITT population included subjects who were randomized in the study.|||Percentage of participants||95% Confidence Interval|Number
2722909|NCT01077518|Secondary|Overall Response Rate (ORR) in All Participants Per IRC|ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.|From randomization until the 217th PFS event occurred, up to about 67.5 months|ITT: The ITT population included subjects who were randomized in the study.|||Percentage of participants||95% Confidence Interval|Number
2722910|NCT01077518|Secondary|Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC|PFS is defined as the time interval between randomization until disease progression or death (due to any cause).|From randomization to the date of first documented disease progression or death due to any cause (67.5 months)|Subjects in ITT with Follicular Lymphoma (FL). ITT population included subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2722911|NCT01077518|Primary|Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|PFS is defined as the time interval between randomization until disease progression or death (due to any cause).|From randomization to the date of first documented disease progression or death due to any cause (67.5 months)|ITT: The Intent-to-Treat (ITT) population included subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2722912|NCT01077401|Secondary|Mean Change in Retinal Thickness at Month 6||baseline to6 Months|Data was not collected for 4 participants in the Ranibizumab 0.5mg group for this outcome measure.|||µm||Standard Deviation|Mean
2722913|NCT01077401|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to Month 6|Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.|baseline 6 Months||||letters||Standard Deviation|Mean
2722914|NCT01077401|Primary|Deaths Due to Myocardial Infarction||6 Months||||participants|||Number
2723232|NCT01075204|Secondary|Cough Status at End of Study|Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.|10 days|Enrolled patients with cough data available.|||participants|||Number
2722915|NCT01077375|Secondary|Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score|The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).|Change from Baseline (Week 3) to Visit 5 (Week 13)|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.|||Units on a scale||Standard Deviation|Mean
2722916|NCT01077375|Primary|Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)|The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.|Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.|||participants|||Number
2722917|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escaped, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
2722918|NCT01077362|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.|||Score on a scale||Standard Deviation|Mean
2722919|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
2722920|NCT01077362|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.|||Percentage of participants|||Number
2722921|NCT01077362|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Score on a scale||Standard Deviation|Mean
2722981|NCT01077024|Primary|Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens|Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.|Week 16||||percentage of weeks|||Number
2722922|NCT01077362|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
2722923|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Past Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is past use period, described as time following recent use excluding subsequent current or recent use."|43 months|Time on Drug Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
2722924|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is the recent use period, described as time following current use plus an additional 31 days excluding subsequent current use."|43 months|Time on Drug Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
2722925|NCT01077323|Secondary|Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis Among Initiators of Exenatide, Diabetics Initiating Other Antidiabetic Drugs, and the Non-diabetes Cohort - Intent to Treat Analysis|Crude intent-to-treat incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort.|43 months|Intent to Treat Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
2722926|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is current use period, described as time during current day's supply plus 31 days."|43 months|Time on Drug Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
2722927|NCT01077310|Other Pre-specified|Mean Change in CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.|Baseline and every 3 months for 1 year|These data were not able to be collected for analysis.||||||
2722928|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days|change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.|change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release||||percent of heavy drinking days||Standard Deviation|Mean
2722929|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day|The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day|12 weeks prior to release from prison (baseline) to 6 months post release||||standard units of alcohol||Standard Deviation|Mean
2722930|NCT01077310|Secondary|Alcohol Treatment Outcome: Time to Alcohol Relapse|Self reported time to first heavy drinking day after release from incarceration, up to 6 months|Post release||||days||Standard Deviation|Mean
2722931|NCT01077310|Primary|Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL|Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.|Baseline to month 6 post release|Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.|||percent of participants|||Number
2722932|NCT01077284|Secondary|Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance|Creatinine clearance is a measure of how well the kidneys are filtering creatinine, a waste product produced by the muscles. Measured creatinine clearance was calculated according to the following: Urine 24 hour Creatinine/Serum Creatinine x (total Urine volume/elapsed time) x (1.73/body surface area).|Baseline and Month 6|Full analysis set. Missing Month 6 Visit 24-hour mCLcr values are imputed by Month 3 values if the Month 3 value was available otherwise the patient was excluded from the analysis.|||mL/min/1.73m²||Standard Deviation|Mean
2722933|NCT01077284|Secondary|Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones|Multidetector Computed Tomography (MDCT) was used to visualize and count calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader.|Baseline and Month 6|Full analysis set for whom both Baseline and Month 6 MDCT data were available. Measurements more than 1 day after a patient’s last dose of study drug were not included.|||stones||Standard Deviation|Mean
2722934|NCT01077284|Secondary|Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone|Multidetector Computed Tomography (MDCT) was used to visualize and measure calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader. The change from Baseline to month 6 is expressed as a percentage of the Baseline largest in-plane diameter.|Baseline and Month 6|Full analysis set, for whom Baseline and Month 6 MDCT data were available. Measurements more than 1-day after a patient's last dose of study drug were not included.|||percent change||Standard Deviation|Mean
2723031|NCT01076205|Secondary|Number of Inpatient Hospitalizations in Past 6 Months|Participants self-reported the number of hospitalizations they had in the past 6 months.|Baseline, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||hospitalizations||Standard Deviation|Mean
2722935|NCT01077284|Primary|Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion|The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.|Baseline and Month 6|The full analysis set (patients who took at least 1 dose of double-blind study drug and had a baseline 24-hour uUA >700 mg and at least 1 kidney CaOx stone ≥3 mm in its longest inplane diameter). Missing Month 6 values were imputed with baseline values if patient discontinued due to an AE; or otherwise with the last available post-baseline value.|||percent change||Standard Deviation|Mean
2722936|NCT01077271|Secondary|Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale|The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.|One RSV season (5 months), end of study|The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.|||units on a scale||Standard Deviation|Mean
2722937|NCT01077271|Secondary|Parents Knowledge of Burden of RSV Disease Via Interview by Physician|"An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have good RSV awareness if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly."|One RSV season (5 months)|The analysis included parents of participants who were administered and had data available for the study visits listed.|||Parents of participants|||Number
2722938|NCT01077271|Secondary|Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)|The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.|One RSV season (5 months)|The analysis included participants who were administered palivizumab and had data available for the study visits listed.|||units on a scale||Standard Deviation|Mean
2722939|NCT01077271|Primary|Dosage Per Administration|The median dose and range of palivizumab (milligrams) that was administered at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.|||milligrams||Full Range|Median
2722940|NCT01077271|Primary|Interval Between Administrations|The average number of days that elapsed between palivizumab injections administered at the previous study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.|||Days||Standard Deviation|Mean
2722941|NCT01077271|Primary|Body Site of Injections Per Administration|The body site of injection administration for participants at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.|||participants|||Number
2722942|NCT01077271|Primary|Number of Injections Per Patient Per Season|The average number of injections administered per participant within a respiratory syncytial virus season.|One RSV season (5 months)|Participants who were administered palivizumab were included in the analysis.|||Injections administered||Standard Deviation|Mean
2722943|NCT01077258|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
2722944|NCT01077258|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Month 6, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
2722945|NCT01077258|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, and 24|Full analysis set participants who were employed and with available data at each time point (indicated by n)|||days||Standard Deviation|Mean
2722946|NCT01077258|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 3, 6, 9, 18, and 24|Full analysis set with available data at each time point|||percentage of participants|||Number
2722947|NCT01077258|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||cm||Standard Deviation|Mean
2722948|NCT01077258|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Month 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||cm||Standard Deviation|Mean
2722949|NCT01077258|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18 and 24|Full analysis set with available data at each time point (indicated by n)|||cm||Standard Deviation|Mean
2722950|NCT01077258|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|"A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:~FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||units on a scale||Standard Deviation|Mean
2722951|NCT01077258|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||swollen joints||Standard Deviation|Mean
2722952|NCT01077258|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||tender joints||Standard Deviation|Mean
2722953|NCT01077258|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||mg/L||Standard Deviation|Mean
2722954|NCT01077258|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||mm/hour||Standard Deviation|Mean
2722955|NCT01077258|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.~Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point|||percentage of participants|||Number
2722956|NCT01077258|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
2722957|NCT01077258|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
2722958|NCT01077258|Primary|Change From Baseline in Disease Activity Score (DAS) 28|The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
2722959|NCT01077193|Primary|Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward|"Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.~One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL"|3 years||||percentage of baseline excess weight||Standard Deviation|Mean
2722982|NCT01076985|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|"The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During pregnancy and for one year after birth|All available observed data for all participants and their resulting infants/live births are included.|||participants|||Number
2722960|NCT01077154|Secondary|Distant Recurrence-free Survival|"Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date.~Distant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence.~Since the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported."|From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2722961|NCT01077154|Secondary|Overall Survival|"Overall survival (OS) time was defined as the time interval from the randomization date to the date of death from any cause. Participants last known to be alive were censored at their last contact date.~Since the median time to overall survival could not be estimated at the time of the final analysis due to low numbers of events, the percentage of participants with an event (i.e., death) is reported."|From randomization until the end of study; median (minimum, maximum) time on study was 72.7 (0, 92) and 72.3 (0, 92) months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2722962|NCT01077154|Secondary|Disease-free Survival (DFS) in the Postmenopausal Subset|"DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date.~Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence.~Since the median DFS time in the postmenopausal subset could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported."|From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.|"Randomized participants postmenopausal at enrollment, defined as:~Undergone bilateral oophorectomy~Age ≥ 60 years~Age 45 to 59 years with 1 of the criteria, ie, either amenorrhea > 12 months with an intact uterus and ≥ 1 intact ovary; or amenorrhea for ≤ 12 months and follicle-stimulating hormone and estradiol in postmenopausal range."|||percentage of participants||95% Confidence Interval|Number
2722963|NCT01077154|Secondary|Disease-free Survival (DFS)|"DFS time was defined as the time interval from the randomization date to the date of first observation of disease recurrence or death from any cause, whichever was first. Participants last known to be alive with no disease recurrence were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first disease recurrence before randomization were censored at their randomization date.~Disease recurrence includes bone metastasis and extraosseous disease (EOD) confirmed by central imaging analysis or by biopsy/cytology. Development of non-breast cancer new primary malignancy was not considered as disease recurrence.~Since the median DFS time could not be estimated due to low number of events, the percentage of participants with an event (i.e., disease recurrence or death) is reported."|From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2722964|NCT01077154|Primary|Bone Metastasis-free Survival (BMFS)|"BMFS time was defined as the time interval from the randomization date to the first occurrence of bone metastasis or death from any cause, whichever came first. Participants last known to be alive with no bone metastasis were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first occurrence of bone metastasis before randomization were censored at their randomization date.~Bone metastasis must have been confirmed by central imaging analysis or by biopsy, Evidence of disseminated tumor cells in bone marrow was not sufficient for determination of disease recurrence. Development of new primary malignancy in bone was not considered as bone metastasis.~Since the median BMSF time could not be estimated due to low number of events, the percentage of participants with an event (i.e., bone metastasis or death) is reported."|From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2722965|NCT01077128|Secondary|Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization|An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)||||Participants|||Number
2722966|NCT01077128|Secondary|Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.~It has two components:~the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and~the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either problem or no problem with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||units on a scale||Standard Deviation|Mean
2722967|NCT01077128|Secondary|"Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)"|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.~It has two components:~the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and~the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either problem or no problem with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||Percentage of patients with no problem|||Number
2722968|NCT01077128|Secondary|Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region|The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician's Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants' quality of life.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||units on a scale||Standard Deviation|Mean
2722969|NCT01077128|Secondary|Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores|The Physician's Global Assessment of disease severity (PGA) was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||Percentage of patients improving|||Number
2722970|NCT01077128|Primary|Mean Change of Dermatology Life Quality Index (DLQI) Scores|DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||units on a scale||Standard Deviation|Mean
2722971|NCT01077076|Primary|Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment|Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments|4 hours after dose on Day 4|"Pharmacodynamic-Evaluable Population: All participants who presented valid data from all three study periods.~One participant was dropped from the Pharmacodynamic-Evaluable Population in the Prilosec OTC Tablets group because of invalid pH tracings at Day 4. Therefore, the number of participants included at Day 4 in this group was 26."|||Percentage of Time||Standard Deviation|Mean
2722972|NCT01077063|Primary|Safety of Pleurx Catheter or Paracentesis|"Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis~Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure."|3 years||||events|||Number
2722973|NCT01077050|Secondary|Sensitivity and Specificity|"Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.~Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)~Negative Reference Diagnosis: All other skin lesions."|Post data lock||2013-08-31|08/2013||||
2722974|NCT01077050|Primary|SciBase Sensitivity and Specificity|"This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:~Sensitivity ≥ 0.90 to detect Melanoma~Sensitivity - (1-Specificity) > 0.00~Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma."|Post data lock|Biopsied Skin Lesions|||Percentage of total lesions|Participants|95% Confidence Interval|Mean
2722975|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|6 month visit||||percentage of participants|||Number
2722976|NCT01077024|Secondary|Stimulant-free Results at 6-month Visit|At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|6 - months follow-up visit|This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively).|||percentage of participants|||Number
2722977|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|3- month follow-up visits||||percentage of participants|||Number
2722978|NCT01077024|Secondary|Stimulant-free Results at 3-month Visit|At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|3-month follow-up visit|This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively).|||percentage of participants|||Number
2722979|NCT01077024|Secondary|Four Week Continuous Smoking Abstinence|A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 - 42.|Post-quit days 15-42||||percentage of participants|||Number
2722980|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome)|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|Week 10 assessment||||percentage of participants|||Number
2723233|NCT01075204|Secondary|Fever Status at End of Study|Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.|10 days|All enrolled patients|||participants|||Number
2722983|NCT01076972|Primary|Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents|Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).|Baseline (Month 0) and following last treatment dose during the course of the survey period|Available data for all patients were included.|||participants|||Number
2722984|NCT01076972|Primary|Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit|Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.|||copies/mL||Standard Deviation|Mean
2722985|NCT01076972|Primary|Cluster of Differentiation 4 Lymphocyte Count (CD4)|The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.|||cells per cubic millimeter||Standard Deviation|Mean
2722986|NCT01076972|Primary|Total Number of Patients With Adverse Drug Reactions|"Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During the course of the survey period up to Year 8|Available data for all patients were included.|||participants|||Number
2722987|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||Percentage of Patients|||Number
2722988|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 12|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||percentage of patients|||Number
2722989|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 4|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||Percentage of patients|||Number
2722990|NCT01076959|Secondary|Physicians' Overall Effectiveness Response Rating|"Physicians' rated the level of overall patient improvement as markedly improved, improved, not changed, or not assessable by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions."|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||Percentage of Patients|||Number
2723032|NCT01076205|Secondary|Number of Physician Visits in Past 6 Months|Participants self-reported the number of physician visits they had in the past 6 months.|Baseline, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||visits||Standard Deviation|Mean
2722991|NCT01076959|Primary|Total Number of Patients With Adverse Events|Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.|Baseline to Week 24|The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.|||Percentage of Patients|||Number
2722992|NCT01076686|Primary|Number of Subjects With Breast Implant Rupture|Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty|12 to 24 months post surgery||||participants|||Number
2722993|NCT01076647|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
2722994|NCT01076647|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2722995|NCT01076543|Secondary|Overall Survival (OS) (Phase II)|Kaplan-Meier curves will be generated for OS stratified by histology; median OS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.|Time from study entry until death from any cause, assessed up to 6 years|"Only phase II patients were followed for overall survival.~Note:999999 for the upper confidence interval of the median for the follicular subtype means not estimable."|||Months||90% Confidence Interval|Median
2722996|NCT01076543|Secondary|Progression-free Survival (PFS) (Phase II)|Kaplan-Meier curves will be generated for PFS stratified by histology; median PFS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.|Time from study entry until disease progression or death from any cause, assessed up to 5 years|Note: Only phase II patients were followed for progression-free survival.|||Months||90% Confidence Interval|Median
2722997|NCT01076543|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|Only phase II patients were assessed for overall response.|||Participants|||Count of Participants
2722998|NCT01076543|Primary|Complete Response (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions;|Up to 1 year|Only phase II patients were assessed for complete response.|||Participants|||Count of Participants
2722999|NCT01076543|Primary|Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only|Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|28 days|Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).|||Participants|||Count of Participants
2723000|NCT01076504|Secondary|Toxicity/Safety|Grade 3/4 toxicities|36 months|All enrolled and treated patients|||participants|||Number
2723001|NCT01076504|Secondary|Overall Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|84 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
2723002|NCT01076504|Secondary|Time to Progression|Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 months|Includes all enrolled and treated patients|||weeks||Full Range|Median
2723003|NCT01076504|Secondary|Objective Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|36 months|Includes all patients who were treated and evaluated for response (74 patients - 6 were deemed not evaluable)|||percentage of evaluable participants|||Number
2723004|NCT01076504|Primary|1-year Survival|Percentage of patients still alive one year after their first treatment|12 months|All enrolled and treated patients|||percentage of participants||95% Confidence Interval|Number
2723005|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part IV includes four categories (11 items) related to dyskinesias, clinical fluctuations of symptoms, and other complications. A summary score ranging from 0 to 23 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months||||units on a scale||Standard Deviation|Mean
2723006|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part II has 13 items focusing on activities of daily living including walking, writing, dressing and speech. A summary score ranging from 0 to 52 is generated by adding the 13 items. The higher score indicates worse condition.|Baseline and 24 months||||units on a scale||Standard Deviation|Mean
2723062|NCT01076179|Secondary|Number of Participants With HIV-1 Coreceptor Tropism During Follow-up|Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.|up to Week 144|Since this was an observational study, resistance testing was performed at the discretion of the treating physician. No follow-up data on tropism was collected.||||||
2723007|NCT01076452|Primary|The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication.|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The higher score indicates the worse motor function.|Baseline and 24 months||||units on a scale||95% Confidence Interval|Mean
2723008|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part I has four items assessing intellectual impairment, thought disorder, depression and motivation. A summary score ranging from 0 to16 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months||||units on a scale||Standard Deviation|Mean
2723009|NCT01076400|Primary|Part 2: Length of Time for Progression-free Survival (PFS)|PFS is the length of time during and after treatment that a participant lives, but whose tumor progression does not worsen. PFS is defined as the time from randomization to progressive disease or death, whichever occurs earlier. Tumor volume changes of +20% for progressive disease was used to be consistent with RECIST 1.1.|Up to approximately 1 year|Due to the early termination of the study Part 2 was not performed.||||||
2723010|NCT01076400|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|A DLT is a protocol-defined, (hematologic and non-hematologic), AE that must be definitely, probably, or possibly related to the study therapy. A DLT is any of the following: Grade 4-5 hematological toxicity; Grade 3 or Grade 4 neutropenia with fever >38.°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic dose-limiting toxicities are any Grade 3, 4, or 5 non-hematologic toxicity, with specific exceptions. If occurring within the first cycle of combination therapy: unresolved drug-related toxicity, preventing (re) treatment for 3 weeks or more from the date of the next scheduled treatment or any drug-related toxicity preventing the participant from taking at least 75% of the doses of MK-1775 with each administration of chemotherapy.|Up to approximately 1 year|Participants who completed the first cycle of combination therapy or discontinued from the study due to a DLT attributable to study therapy. One participant who violated the protocol was not assessed for DLTs.|||Number of participants|||Number
2723011|NCT01076400|Primary|Part 1: Percentage of Participants Whose Best Confirmed Response is Partial Response (PR) or Complete Response (CR)|On the basis of Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PR is at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. CR is the disappearance of all extranodal target lesions, where all pathological lymph nodes must have decreased to <10 mm in the short axis.|Up to approximately 1 year|The study was prematurely terminated, and data were not collected, so no analyses were performed.||||||
2723012|NCT01076361|Primary|Survival Probability of the Model 4968 Lead Based on Lead-related Complications|The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.|The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.|22 Model 4968s (in 21 participants) was not available for analysis|||percentage of Model 4968 Leads|Participants|95% Confidence Interval|Number
2723013|NCT01076348|Primary|Model 4965 Complication Free Rate|A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.|1 year|Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.|||Model 4965 complication free rate|4965 leads|95% Confidence Interval|Number
2723014|NCT01076335|Primary|Number of Participants Progression Free at 1 Year|Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml − 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.|1 Year|One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis.|||participants|||Number
2723015|NCT01076296|Primary|Percentage of Correct Diagnosis|A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.|2 years||||percentage of correct diagnosis||95% Confidence Interval|Number
2723016|NCT01076283|Primary|Alcohol Drinking|"Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration (ASA).~Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour free-choice phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as standard drinking unit, where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons)."|approximately 8 days after drug administration||||standard drinking units||Standard Deviation|Mean
2723029|NCT01076205|Secondary|Number of Days With Impairment of Non-Occupational Activities in Past 6 Months|Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days.|Baseline, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||days||Standard Deviation|Mean
2723017|NCT01076283|Primary|Alcohol Urge|"Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Urge Questionnaire (AUQ)] during the Cue Reactivity.~The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from strongly disagree to strongly agree. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome)."|approximately 8 days after drug administration||||units on a scale||Standard Deviation|Mean
2723018|NCT01076270|Secondary|CD34-positive Cells Collected|Number of CD34-positive cells collected per kg recipient body weight|At the end of apheresis for cell collection|Trial terminated; only one patient enrolled|||CD34-positive cells collected/kg|||Number
2723019|NCT01076270|Primary|Successful Collection of Stem Cells|Percentage of donors from whom at least 2 x 10^6 CD34+ cells/kg body weight were collected based on actual recipient body weight|At the end of apheresis for cell collection|Study terminated early. Results are for the one donor enrolled.|||Participants|||Count of Participants
2723020|NCT01076244|Secondary|Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).|For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.|Baseline and month 6|All available patients at the month 6 reporting period were analyzed.|||units on a scale||95% Confidence Interval|Mean
2723021|NCT01076244|Primary|Pain as Measured by Visual Analog Scale (VAS).|A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and six months|all available patients reporting at Month 6|||units on a scale||95% Confidence Interval|Mean
2723022|NCT01076244|Secondary|Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).|As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.|Baseline and month 6|All patients having a month six report report were analyzed.|||units on a scale||95% Confidence Interval|Mean
2723023|NCT01076244|Secondary|Improvement in Functional Mobility|Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.|baseline and month 6|All available patients at six months were analyzed.|||units on a scale||95% Confidence Interval|Mean
2723024|NCT01076205|Secondary|Patient Assessment of Adalimumab Therapy|"Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:~Considerably better~Better~About the same~Worse~Noticeably worse"|Months 3, 6, 12, 24, 36, 48, and 60|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), with available data at each time point.|||percentage of participants|||Number
2723025|NCT01076205|Secondary|Percentage of Participants Taking Concomitant RA Medications|Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.|Baseline to month 60|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set).|||percentage of participants|||Number
2723026|NCT01076205|Secondary|Participant's Assessment of Fatigue|Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2723027|NCT01076205|Secondary|Participant's Assessment of Pain|Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2723028|NCT01076205|Secondary|Duration of Morning Stiffness||Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||minutes||Standard Deviation|Mean
2723030|NCT01076205|Secondary|Duration of Inpatient Hospitalizations in Past 6 Months|Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.|Baseline, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||days||Standard Deviation|Mean
2723033|NCT01076205|Primary|Change From Baseline in Euroqol Visual Analog Scale (VAS)|"EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning the best health you can imagine and 0 meaning the worst health you can imagine."|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2723034|NCT01076205|Primary|EuroQol-5 Dimensions (EQ-5D) Scores|"The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):~agility/mobility~self-care~usual activities~pain, bodily discomfort~anxiety, depression~For each dimension the patient is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3)."|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||Participants|||Count of Participants
2723035|NCT01076205|Primary|Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2723036|NCT01076205|Primary|Change From Baseline in C-reactive Protein||Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||mg/L||Standard Deviation|Mean
2723037|NCT01076205|Primary|Change From Baseline in Erythrocyte Sedimentation Rate||Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||mm/hr||Standard Deviation|Mean
2723038|NCT01076205|Primary|Change From Baseline in Swollen Joint Count|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||joints||Standard Deviation|Mean
2723039|NCT01076205|Primary|Change From Baseline in Tender Joint Count|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||joints||Standard Deviation|Mean
2723040|NCT01076205|Primary|Change From Baseline in Disease Activity Score - 28 Joints (DAS28)|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission.|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2723041|NCT01076205|Primary|Change From Baseline in Work Activity Index (WAI)|The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).|Baseline and 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WAI data.|||units on a scale||Standard Deviation|Mean
2723042|NCT01076205|Primary|Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment|"The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.~WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes."|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and with available WPAI data.|||percent impairment||Standard Deviation|Mean
2723063|NCT01076179|Secondary|Number of Participants With HIV-1 Coreceptor Tropism at Baseline|Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
2723264|NCT01075100|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months|24 months|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2723043|NCT01076205|Primary|Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment|"The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.~WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes."|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.|||percent impairment||Standard Deviation|Mean
2723044|NCT01076205|Primary|Change From Baseline in Work Productivity and Activity Impairment: Presenteeism|"The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.~WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes."|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.|||percent impairment||Standard Deviation|Mean
2723045|NCT01076205|Primary|Change From Baseline in Work Productivity and Activity Impairment: Absenteeism|"The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.~WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes."|Baseline and 3, 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.|||percent impairment||Standard Deviation|Mean
2723046|NCT01076205|Primary|Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months|Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.|Baseline, 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at each time point.|||percentage of participants|||Number
2723047|NCT01076205|Primary|Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months|Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.|Baseline and 6, 12, 24, 36, 48, and 60 months|Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at baseline and each time point.|||days||Standard Deviation|Mean
2723048|NCT01076192|Secondary|Number of Participants With Serious Adverse Events (SAEs)|"SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion.~See the Reported Adverse Events Section for more details."|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.|||participants|||Number
2723049|NCT01076192|Primary|Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)|The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
2723050|NCT01076192|Primary|Mean Change From Baseline in Body Surface Area (BSA) Affected|Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of body surface area||Standard Deviation|Mean
2723051|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
2723096|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of Oral Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
2723052|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
2723053|NCT01076192|Secondary|Number of Participants With Adverse Events of Special Interest (AESIs)|AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.|||participants|||Number
2723054|NCT01076192|Secondary|Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.|||units on a scale (a derived score)||Standard Deviation|Mean
2723055|NCT01076192|Secondary|Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2723056|NCT01076192|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2723057|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
2723058|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
2723059|NCT01076192|Primary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data.|||units on a scale||Standard Deviation|Mean
2723060|NCT01076179|Other Pre-specified|Time to Virologic Failure|"Time to virologic failure was defined by the earliest occurrence of:~HIV-1 RNA > 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA < 50 copies/mL,~HIV-1 RNA > 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA < 50 copies/mL but subsequently did not have HIV-1 RNA > 400 copies/mL on 2 consecutive occasions, or~Day 1 if the participant never achieved HIV-1 RNA < 50 copies/mL during study participation.~A participant who prematurely discontinued study drug with HIV-1 RNA < 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c)."|Baseline (Week 0) to Week 144|Participants with an assessment|||weeks||Standard Error|Mean
2723061|NCT01076179|Other Pre-specified|Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||log copies/mL||Standard Deviation|Mean
2723064|NCT01076179|Secondary|Number of Participants With NRTI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
2723065|NCT01076179|Secondary|Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
2723066|NCT01076179|Secondary|Number of Participants With NNRTI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
2723067|NCT01076179|Secondary|Number of Participants With NNRTI Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
2723068|NCT01076179|Secondary|Number of Participants With INI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up (neither had available Baseline testing); since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
2723069|NCT01076179|Secondary|Number of Participants With INI Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
2723070|NCT01076179|Secondary|Number of Participants With PI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Up to Week 144|Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
2723071|NCT01076179|Secondary|Number of Participants With Protease Inhibitor (PI) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.~Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
2723072|NCT01076179|Secondary|Number of Participants With LPV Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
2723073|NCT01076179|Secondary|Number of Participants With Lopinavir (LPV) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.~Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
2723074|NCT01076179|Secondary|Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL||From Week 0 to Week 144|Participants with an assessment|||weeks||Standard Error|Mean
2723075|NCT01076179|Secondary|Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis|Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point.|||percentage of participants|||Number
2723076|NCT01076179|Secondary|Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis|Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method).|||percentage of participants|||Number
2723077|NCT01076179|Secondary|Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count|Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||cells/μL||Standard Deviation|Mean
2723078|NCT01076179|Primary|Prevalence of Adverse Events (Weeks 0-144), Per Participant|Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of participants|||Number
2723079|NCT01076179|Primary|Prevalence of Adverse Events (Weeks 0-144), Per Event|Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of adverse events|Adverse Events||Number
2723080|NCT01076166|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.|||Participants|||Number
2723081|NCT01076166|Primary|Average Time From Baseline to Recovery From Fever and Other Symptoms|Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients.|||Days||Standard Deviation|Mean
2723082|NCT01076153|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.|||Events|||Number
2723152|NCT01075646|Secondary|Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)||During 8-15 days||||participants|||Number
2723153|NCT01075646|Secondary|Secondary Effects Due to Morphine: Nausea and Vomiting||during 48 hours||||participants|||Number
2723083|NCT01076153|Primary|Average Time From Baseline to Recovery From Cough and Other Symptoms|Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|The per-protocol population consisted of 694 participants as 66 participants were excluded for protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).|||Days||Standard Deviation|Mean
2723084|NCT01076088|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for FPG. Last observation carried forward (missing data approach).|||mg/dL||95% Confidence Interval|Least Squares Mean
2723085|NCT01076088|Secondary|Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24|Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for 2-h PMG subsequent to at least 1 dose of study treatment, or lacked baseline data for 2-h PMG. Last observation carried forward (missing data approach).|||mg/dL||95% Confidence Interval|Least Squares Mean
2723086|NCT01076088|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2723087|NCT01076075|Primary|Number of Participants Discontinuing Study Drug Due to An Adverse Event||Week 0 to Week 54|The All Patients as Treated Population took at least 1 dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Participants discontinued due to adverse events are reported regardless of rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.|||participants|||Number
2723088|NCT01076075|Primary|Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54||Week 0 to Week 54|The All Patients as Treated Population took at least one dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Adverse events include those that occurred prior to a receiving rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.|||participants|||Number
2723089|NCT01076075|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value.|Baseline to Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.|||mg/dL||95% Confidence Interval|Least Squares Mean
2723090|NCT01076075|Secondary|Change From Baseline in 2-hour Post-Meal Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.|||mg/dL||95% Confidence Interval|Least Squares Mean
2723091|NCT01076075|Primary|Change From Baseline in Hemoglobin A1C (%) at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2723092|NCT01076036|Primary|Procedural Technical Success|Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.|Intervention|Total number of PCI devices.|||percentage of PCI devices|||Number
2723093|NCT01076036|Primary|Clinical Procedural Success|The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)|48-hrs or hospital discharge, whichever occurs first||||percentage of participants|||Number
2723094|NCT01075984|Primary|Steady State Apparent Total Body Clearance of Oral Posaconazole (CL/F)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|CL/F for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter||||||
2723095|NCT01075984|Primary|Steady State Average Concentration of Oral Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (12 hours).|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
2723154|NCT01075646|Secondary|Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.||7 Days (from Day 8-15)||||hours||Inter-Quartile Range|Median
2723097|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of Oral Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||Hours||Full Range|Median
2723098|NCT01075984|Primary|Steady State Maximum Concentration of Oral Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
2723099|NCT01075984|Primary|Steady State Trough Concentration of Oral Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
2723100|NCT01075984|Primary|Steady State Total Body Clearance of IV Posaconazole (CL)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|CL for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter.||||||
2723101|NCT01075984|Primary|Steady State Average Concentration of IV Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (24 hours).|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||ng/mL||Standard Deviation|Mean
2723102|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||hour*ng/mL||Standard Deviation|Mean
2723103|NCT01075984|Primary|Single Dose Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
2723104|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||Hours||Full Range|Median
2723105|NCT01075984|Primary|Single Dose Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0 and 1)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||Hours||Full Range|Median
2723106|NCT01075984|Primary|Steady State Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||ng/mL||Standard Deviation|Mean
2723107|NCT01075984|Primary|Single Dose Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
2723108|NCT01075984|Primary|Steady State Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||ng/mL||Standard Deviation|Mean
2723109|NCT01075984|Primary|Single Dose Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
2723110|NCT01075971|Primary|The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.|"Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from Not at all satisfied (score = 0) to Totally satisfied (score = 10)."|Daily, Day 1 to Day 5||||Score on a scale||Standard Deviation|Mean
2723111|NCT01075958|Primary|Word Recognition (Episodic Memory)|The original 15 words plus 15 distractor words were presented one at a time in a random order. For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate 'yes' and 'no' keys as quickly as possible. Stimuli remained on screen until an appropriate response had been made.|Single visit||||percent of correct responses||Standard Error|Mean
2723112|NCT01075958|Primary|Delayed Word Recall (Episodic Memory)|The participant was again given 60 seconds to write down as many of the words presented previously as possible.|Single visit||||Number of words recalled||Standard Error|Mean
2723113|NCT01075958|Primary|Immediate Word Recall (Episodic Memory)|A unique set of fifteen words is presented. Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness. Stimulus duration was one second, as was the inter-stimulus duration. Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.|Single visit||||Number of words recalled||Standard Error|Mean
2723114|NCT01075958|Primary|3-back Task (Working Memory)|A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs. For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.|Single visit||||percent of correct responses||Standard Error|Mean
2723115|NCT01075958|Primary|Corsi Blocks Span (Spatial Working Memory)|In this task nine identical blue squares appeared on screen in non-overlapping random positions. A set number of blocks changed colour from blue to red in a randomly generated sequence. Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor. The task was repeated five times at each level of difficulty. The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.|Single visit||||Blocks remembered in sequence||Standard Error|Mean
2723116|NCT01075958|Primary|Alphabetic Working Memory (Working Memory)|Five random letters (A-Z) were presented sequentially for the participant to hold in memory. This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press. The task consisted of 3 separate trials.|Single visit||||percent of correct responses||Standard Error|Mean
2723117|NCT01075958|Primary|Numeric Working Memory (Working Memory)||Single visit||||percent of correct responses||Standard Error|Mean
2723118|NCT01075958|Primary|Four Choice Reaction Time (Attention)|A visual representation of the four direction arrow keys of a standard keyboard was presented on screen. The arrows 'lit up' at random on screen until the corresponding key press was made. In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.|Single visit||||ms||Standard Error|Mean
2723119|NCT01075958|Primary|Choice Reaction Time (Attention)|An arrow appeared on the screen pointing to the left or to the right. Participants responded with a left or right key press corresponding to the direction of the arrow. There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.|Single visit||||ms||Standard Error|Mean
2723120|NCT01075958|Secondary|Depression, Anxiety and Stress Scale (DASS)|The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Subjects are asked to use 4-point (0-3) severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress (0-42) are calculated by summing the scores for the relevant items, with higher scores indicating higher incidence of negative emotional symptoms. A total score can be derived by adding scores from each of the subscales (0-126).|Single visit-90 minutes||||Scores on a scale||Standard Deviation|Mean
2723121|NCT01075958|Primary|Simple Reaction Time (Attention)|The participant was instructed to press the 'space bar' on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen. Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.|Single visit|Only those participants for whom a venous blood sample was obtained (N=239) were entered into the analysis. A further 20 participants were excluded on the basis that their BMI exceeded 30, and could not be considered 'healthy individuals'.|||ms||Standard Error|Mean
2723122|NCT01075815|Secondary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||cycles|||Number
2723123|NCT01075815|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
2723124|NCT01075815|Secondary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
2723125|NCT01075815|Secondary|Total Number of Births|Total number of births per reporting group was calculated.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents number of participants evaluated for this measure."|||births|||Number
2723126|NCT01075815|Secondary|Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||cycles|||Number
2723127|NCT01075815|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.|S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||Days||Standard Deviation|Mean
2723128|NCT01075815|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants with plasma E2 levels at r-hCG day."|||picogram/milliter (pg/mL)||Standard Deviation|Mean
2723129|NCT01075815|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)||2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||IU||Standard Deviation|Mean
2723130|NCT01075815|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
2723131|NCT01075815|Secondary|Number of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
2723132|NCT01075815|Secondary|Number and Quality of Embryos|Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants who had at least one fertilized oocyte."|||embyros|||Number
2723133|NCT01075815|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||2PN oocytes|||Number
2723134|NCT01075815|Secondary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||mature oocytes|||Number
2723135|NCT01075815|Secondary|Mean Number of Oocytes Retrieved|Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||oocytes||Standard Deviation|Mean
2723136|NCT01075815|Secondary|Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||follicles||Standard Deviation|Mean
2723137|NCT01075815|Primary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.|Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])|Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication.|||sacs per embryo||Standard Deviation|Mean
2723138|NCT01075763|Secondary|Global Deterioration Scale Score|"Global deterioration scale includes seven different diagnostic stages ranging between no cognitive deterioration and very serious cognitive deterioration. It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline)."|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723139|NCT01075763|Secondary|Geriatric Depression Scale (GDS) Score|The GDS consists of 30 'yes' or 'no' items aimed to assess depression. One point is assigned to each answer and the cumulative score is rated on a scoring grid. Scores are grouped as follows: 0-9 'normal', 10-19 'mildly depressed', and 20-30 'severely depressed'.|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723155|NCT01075646|Secondary|Intensity of Pain Measured by Verbal Pain Scale.|Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.|At interval periods during 48 hours||||units on a scale||Inter-Quartile Range|Median
2723140|NCT01075763|Secondary|Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score|CIBIC-PLUS: structured instrument based on comprehensive evaluation of 3 domains: participant cognition, behavior and functioning, including assessment of daily living activities. It includes 15 items and represents assessment of skilled clinician using validated scales based on the observation at interviews conducted separately with participant and caregiver familiar with behavior of participant. According to comparison between baseline and follow-up assessments, scores can range between 1 (markedly improved) and 7 (markedly worsened), with 4 indicating no change observed between two visits.|Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||participants|||Number
2723141|NCT01075763|Secondary|Physical Self-Maintenance Scale (PSMS) Score|PSMS designed as a disability measure for use in planning and evaluating treatment in elderly participants living in community or in institutions, is Guttman scale containing 6 items of self-care. The scale is based on theory that human behavior can be ordered in a hierarchy of complexity, within each category, a further hierarchy of complexity runs from basic to complex activities. It includes 6 items, testing the following areas: toilet use, eating, dressing, physical appearance, deambulation and bath. Scores range between 0 (excellent performance) and 30 (worst performance).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723142|NCT01075763|Secondary|Instrumental Activities of Daily Living (IADL) Score|IADL is used to evaluate participants with early-stage disease, both to assess level of disease and to determine participant's ability of self-care. IADL scale measures functional impact of emotional, cognitive, and physical impairments. It provides information about participants' compromising rate and care he might need. It includes 8 items: testing ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medication and ability to handle finances. Scores range between 0 (impairment) and 8 (full independence).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723143|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score|ADAS-NonCog is a subscale of ADAS aimed to evaluate the non-cognitive features such as mood state and behavioral changes. It takes about 10 minutes to be performed and includes 10 items: testing tearful, depressed mood, concentration/distractibility, uncooperative to testing, delusions, hallucinations, pacing, motor activity increase, tremors and appetite change. Scores range between 0 (excellent performance) and 35 (worst performance).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723144|NCT01075763|Secondary|Mini Mental Status Examination (MMSE) Score|MMSE is a tool for screening cognitive decline associated with dementia. It is a brief examination intended to evaluate an adult participant's level of cognitive functioning. The test is performed in following areas: orientation in time and place, learning and immediate recall, mental control and concentration, short-term recall, naming ability, language expression, verbal comprehension, writing comprehension, writing ability and visual-spatial coordination. Scores range between 0 (maximum cognitive deficit) and 30 (no cognitive deficit).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723145|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Week 12 and 28|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723146|NCT01075763|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Baseline and Week 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
2723147|NCT01075685|Secondary|Change in the Number of Excessive Drinkers|The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week|baseline and 6 weeks||||participants|||Number
2723148|NCT01075685|Secondary|Category of Change in Weekly Alcohol Intake|"Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are:~clinically significant reduction in WAI, defined as a decrease of 10% or over;~clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0);~and no clinically significant change, which includes all other cases."|baseline and 6 weeks||||participants|||Number
2723149|NCT01075685|Secondary|Relative Change in Weekly Alcohol Intake|(6 weeks minus baseline)/baseline|baseline and 6 weeks|Participants with weekly alcohol consumption baseline at 0 were excluded from this analysis|||percent of baseline consumption||Standard Deviation|Mean
2723150|NCT01075685|Primary|Change in Weekly Alcohol Intake|"The unit of standard drink is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks."|baseline and 6 weeks|Only participants who completed the study were included in this analysis|||standard drinks||Standard Deviation|Mean
2723151|NCT01075646|Secondary|Contamination of the Catheter (Microbiologist Analysis)||at 48 hours||||participants|||Number
2723157|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.|Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
2723158|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)|Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up.|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
2723159|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.|Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
2723160|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts|White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
2723161|NCT01075412|Secondary|Chemotherapy Compliance|The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.|post-treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
2723162|NCT01075412|Primary|Percent Difference From Baseline IMRT Plan (%)|The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.|Baseline (pre-treatment)|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Percent difference (%)||Standard Deviation|Mean
2723163|NCT01075399|Primary|Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors|Primary tumor uptake of [F 18]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.|Time between 1st and 2nd scan was 1 to 6 days|Based upon inclusion/exclusion criteria|||participants|||Number
2723164|NCT01075347|Secondary|Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)||every day till total re-epithelization up to 14 days||||participants|||Number
2723165|NCT01075347|Primary|Patients With Corneal Epithelial Healing Time Within 14 Days|Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients.|every day till total re-epithelization up to 14 days||||participants|||Number
2723166|NCT01075321|Secondary|Time to Treatment Failure for All Eligible Patients|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 5 years|Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.|||months||95% Confidence Interval|Median
2723304|NCT01074944|Secondary|PAP: Mean Spleen Volume at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively.|||MN||Standard Deviation|Mean
2723167|NCT01075321|Secondary|Duration of Response for All Eligible Patients|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented.|Up to 5 years|All eligible patients that began study treatment and evaluated as a CR, PR or MR during treatment were included in this analysis.|||months||95% Confidence Interval|Median
2723168|NCT01075321|Secondary|Progression-Free Survival For All Eligible Patients|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years|Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.|||months||95% Confidence Interval|Median
2723169|NCT01075321|Secondary|Overall Survival for All Eligible Patients|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years|Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.|||months||95% Confidence Interval|Median
2723170|NCT01075321|Primary|Best Response to Dose Level 0|Patients were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma (Cheson, et al 2007). A Complete Response (CR) was defined as the disappearance of all evidence of disease, no palpable nodules and bone marrow cleared on biopsy. A Partial Response (PR) was defined as regression of measureable disease and no new sites, with a 50% decrease in sum of the products of dimension (SPD) of nodal masses, and no increase in spleen or liver size. Patients with Waldenstrom's Macroglobulinemia were eligible to be evaluated as a Minor Response (MR) in which a reduction between 25% and 50% of serum monoclonal IgM was observed. A Progression (PD) was defined as having any new lesions or a 50% increase in the SPD of any previously involved nodes. A Stable Disease (SD) is the absence of any of the previously defined responses.|Up to 5 years|All patients that were registered and treated at Dose Level 0 were pooled and included in this endpoint. 9 patients in Phase I and 32 patients in Phase II were treated and evaluable for this endpoint|||Participants|||Count of Participants
2723171|NCT01075321|Primary|Number of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)|The number of dose-limiting toxic events (DLT) for this combination of drug treatment will determine the Maximum Tolerated Dose (MTD) in subsequent phases of this study. The following events were defined as a DLT: a grade 4+ Neutropenia or platelet count decrease, a grade 4 infection, or any grade 3+ non-hematologic event as assessed using Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. Here, the number of patients reporting a DLT are reported|After one 28 day cycle|All Phase 1 patients that began treatment, completed 1 cycle, and were evaluated for cycle 1 toxicity were included in this analysis. Of the 9 registered to Dose Level 1, 2 were ineligible for this endpoint (PD before evaluated and dose error) and 1 cancelled. Phase II patients were not evaluated for dose-limiting toxicity.|||Participants|||Count of Participants
2723172|NCT01075282|Secondary|Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 26, 52, 78, and 83 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
2723173|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
2723174|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2723175|NCT01075282|Secondary|Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.|||milliliter of mercury (mmHG)||Standard Error|Least Squares Mean
2723176|NCT01075282|Secondary|Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable sitting pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2723218|NCT01075243|Secondary|Time to Onset of Meaningful Pain Relief|Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
2723177|NCT01075282|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
2723178|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin||Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picogram/milliliter||Standard Deviation|Mean
2723179|NCT01075282|Secondary|Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
2723180|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units/liter||Inter-Quartile Range|Median
2723181|NCT01075282|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
2723182|NCT01075282|Secondary|Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||events per participant per year||Standard Deviation|Mean
2723183|NCT01075282|Secondary|Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||events|||Number
2723184|NCT01075282|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. The number of participants with at least 1 TEAE is reported.|||participants|||Number
2723200|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723185|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2723186|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2723187|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2723188|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2723189|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index|Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.|||kilograms per square meter (kg/m^2)||Standard Error|Least Squares Mean
2723190|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilogram (kg)||Standard Error|Least Squares Mean
2723191|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Glucagon Concentration|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable glucagon data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
2723192|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
2723193|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMBG data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2723194|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
2723195|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
2723196|NCT01075282|Secondary|Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percent||Standard Error|Least Squares Mean
2723197|NCT01075282|Primary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2723198|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723199|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723216|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 2 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Percentage of participants|||Number
2723201|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723202|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723203|NCT01075256|Primary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723204|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723205|NCT01075256|Primary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
2723206|NCT01075243|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2723207|NCT01075243|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723208|NCT01075243|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723217|NCT01075243|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.|||minutes||Full Range|Median
2723209|NCT01075243|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723210|NCT01075243|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723211|NCT01075243|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723212|NCT01075243|Secondary|Total Pain Relief Score (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723213|NCT01075243|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723214|NCT01075243|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 2 hours post dose|All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
2723215|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 6 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Percentage of participants|||Number
2723229|NCT01075204|Secondary|Abnormal Breathing Sounds Status at End of Study|Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.|10 days|All enrolled patients|||participants|||Number
2723219|NCT01075243|Secondary|Time to Confirmed First Perceptible Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
2723220|NCT01075243|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from Baseline to 6 hours post dose|Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2723221|NCT01075217|Secondary|The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected.~Results are provided for patients with adequate quality."|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.|||participants|||Number
2723222|NCT01075217|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.|||participants|||Number
2723223|NCT01075217|Secondary|The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable. Scores of 3 and 4 were counted as significant motion artifacts.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Patients with significant motion artifact were those with a score of 3 or 4 for motion artifacts in vessels distal to the knee|||participants|||Number
2723224|NCT01075217|Secondary|Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no heat and the right end (10 cm) of the scale indicating the worst heat.~The Heat VAS was completed by the patient before completing the Pain VAS to assess pain."|Immediately after administration of agent using a power injector for the administration|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Group 2 patients provided an assessment of heat by the Heat VAS prior to assessing pain by the Pain VAS.|||centimeters||Standard Deviation|Mean
2723225|NCT01075217|Primary|Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.~The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.~Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only."|immediately after administration of agent using a power injector for the administration|Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.|||centimeters||Standard Deviation|Mean
2723226|NCT01075204|Secondary|Percentage of Participants Compliant With Treatment|Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.|10 days|All enrolled patients.|||percentage of participants|||Number
2723227|NCT01075204|Secondary|Post-nasal Discharge Status at End of Study|Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.|10 days|Enrolled patients with post-nasal discharge data available.|||participants|||Number
2723228|NCT01075204|Secondary|Rhinorrhea Status at End of Study|Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.|10 days|All enrolled patients|||participants|||Number
2723234|NCT01075204|Primary|Classification of Overall Response|"Based on the participant and physician's assessment, overall symptom response was classified as follows:~Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.~Slow Responders: participants showing clinical recovery between Day 6 & Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).~Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms)."|10 days|All enrolled patients|||participants|||Number
2723235|NCT01075204|Primary|Percentage of Participants With Clinical Success|Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.|10 days|All enrolled patients.|||percentage of participants||95% Confidence Interval|Number
2723236|NCT01075204|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.~If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):~Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.~Please see Adverse Events section below for more details."|10 days|All enrolled patients.|||participants|||Number
2723237|NCT01075204|Secondary|Factors Affecting the Speed of Recovery|Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.|10 days|All enrolled patients|||coefficient|||Number
2723238|NCT01075204|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.~Participants with treatment failure were further categorized as:~All symptoms improved but not resolved within the study period;~Some symptoms improved and some resolved;~Some symptoms resolved or improved while other symptoms did not improve (unchanged);~Some symptoms resolved or improved while other symptoms became worse."|10 days|All enrolled patients|||percentage of participants|||Number
2723239|NCT01075204|Primary|Percentage of Participants With a Fast Recovery|"Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.~Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom."|Day 1 to Day 5|All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.|||percentage of participants|||Number
2723240|NCT01075191|Secondary|Change From Baseline in CD4/CD8 T-cell Ratio|The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||ratio||Standard Deviation|Mean
2723241|NCT01075191|Secondary|Change From Baseline in Relative CD8 Cell Count|Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||percentage of cells||Standard Deviation|Mean
2723242|NCT01075191|Secondary|Change From Baseline in Absolute CD8 Cell Count|Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||cells/µL||Standard Deviation|Mean
2723243|NCT01075191|Secondary|Change From Baseline in Relative CD4 Cell Count|Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||percentage of cells||Standard Deviation|Mean
2723244|NCT01075191|Secondary|Change From Baseline in Absolute CD4 Cell Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||cells/µL||Standard Deviation|Mean
2723305|NCT01074944|Secondary|PAP: Mean Platelet Count at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||platelets*10^9 /L||Standard Deviation|Mean
2723245|NCT01075191|Primary|Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL|Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||percentage of participants|||Number
2723246|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death|The number of subjects who died|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
2723247|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia|The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
2723248|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.|The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
2723249|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death|The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
2723250|NCT01075152|Other Pre-specified|Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26|Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy).|26 weeks|among persons with a measured CSF white cell count at randomization (Day 7-11 of amphotericin treatment)|||percentage of participants|||Number
2723251|NCT01075152|Secondary|Microbiologic Clearance|Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day.|4 weeks|All participants with >2 quantitative CSF cultures obtained|||log10 CFU/mL/day||95% Confidence Interval|Mean
2723252|NCT01075152|Secondary|Karnofsky Functional Status|"Functional status via Karnofsky performance status score at 4, 26, 46 weeks.~Karnofsky Scale:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment necessary.~10 - Moribund; fatal processes progressing rapidly. 0 - Dead"|46 weeks|Analysis is of persons alive at the time point.|||Scores on a scale||Standard Deviation|Mean
2723253|NCT01075152|Secondary|Antiretroviral Therapy Tolerability|Incidence of antiretroviral therapy interruption by >=3 consecutive days|26 weeks|Analysis is of persons who survived to initiate HIV therapy.|||participants|||Number
2723254|NCT01075152|Secondary|HIV-1 Viral Suppression|HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment|26 weeks|Among persons alive at 26 weeks. 1 participant in the early ART arm had consent withdrawn by their family on day 2 after study entry. 3 participants in the deferred ART arm missing their 26 week viral load sampling.|||participants|||Number
2723255|NCT01075152|Secondary|46-week Survival|46-week survival by time-to-event analysis of all subjects enrolled|46 weeks||||participants|||Number
2723256|NCT01075152|Secondary|Safety of ART Initiation|Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009.|46 weeks||||participants|||Number
2723257|NCT01075152|Secondary|Incidence of Cryptococcal-relapse|Incidence of culture positive cryptococcal meningitis relapse|46 weeks||||participants|||Number
2723258|NCT01075152|Secondary|Incidence of Immune Reconstitution Inflammatory Syndrome|Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment.|46 weeks|analysis is of persons who survived to initiate HIV therapy|||participants|||Number
2723259|NCT01075152|Primary|Mortality|Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26.|26 weeks from study entry||||participants|||Number
2723260|NCT01075100|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|30 months|Patients who achieved CR or PR.|||months||Full Range|Median
2723261|NCT01075100|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|24 months|Patients who achieve a major objective response (CR or PR).|||months||Full Range|Median
2723262|NCT01075100|Secondary|Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|24 months|ITT population|||months||95% Confidence Interval|Median
2723263|NCT01075100|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|24 months|ITT population|||months||95% Confidence Interval|Median
2723265|NCT01075100|Primary|Objective Response Rate (ORR)|"Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 months|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2723266|NCT01075087|Secondary|24 Hour Total Opioid Consumption.|24 Hour total opioid consumption translated into IV morphine equivalents.|24 hours||||miligram IV morphine equivalents||Inter-Quartile Range|Median
2723267|NCT01075087|Primary|Quality of Recovery 40 Score|Quality of Recovery 40 Score at 24 hours postoperative.|24 hours post operatively||||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
2723268|NCT01075074|Secondary|Time to Hospital Discharge Readiness|Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||minutes||Inter-Quartile Range|Median
2723269|NCT01075074|Secondary|Opioid Pain Medications Consumed During the First 24 Hours Post Surgery|Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||mEq of PO morphine equivalent||Full Range|Mean
2723270|NCT01075074|Secondary|Pain Burden During Early Recovery From Anesthesia|Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.|Post Operative|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||score on a scale * minutes||Inter-Quartile Range|Median
2723271|NCT01075074|Primary|The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery|The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.|24 hours after surgery|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||units on a scale||Full Range|Median
2723272|NCT01074944|Secondary|LTTP: Mean Biomarker (MIP1-beta) Value at Baseline, 1 Year, and 2 Years|MIP1-beta biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||pg/mL||Standard Deviation|Mean
2723273|NCT01074944|Secondary|LTTP: Mean Biomarker (GL-1 on DBS) Value at Baseline, 1 Year, and 2 Years|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||mcg/mL||Standard Deviation|Mean
2723274|NCT01074944|Secondary|LTTP: Mean Biomarker (Chitotriosidase) Value at Baseline, 1 Year, and 2 Years|Chitotriosidase biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||nmol/hr/mL||Standard Deviation|Mean
2723275|NCT01074944|Secondary|LTTP: Total Bone Marrow Burden Score (BMB) at Baseline, 1 Year, and 2 Years|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||BMB Score||Standard Deviation|Mean
2723276|NCT01074944|Secondary|LTTP: Total Z-scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||Z-score||Standard Deviation|Mean
2723277|NCT01074944|Secondary|LTTP: Total T-Scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||T-score||Standard Deviation|Mean
2723278|NCT01074944|Secondary|LTTP: Bone Mineral Density (BMD) at Baseline, 1 Year, and 2 Years|BMD measurements of the spine and bilateral femur were acquired by DXA scan.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||g/cm^2||Standard Deviation|Mean
2723279|NCT01074944|Secondary|LTTP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, 1 Year, and 2 Years|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||participants|||Number
2723306|NCT01074944|Secondary|PAP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26 and 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||g/dL||Standard Deviation|Mean
2723280|NCT01074944|Secondary|LTTP: Number of Participants With Bone Crises Assessment at Baseline, 1 Year and 2 Years|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crises, 1= 1 bone crisis during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||participants|||Number
2723281|NCT01074944|Secondary|LTTP: Number of Participants With Mobility Status (MS) at Baseline, 1 Year and 2 Years|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||participants|||Number
2723282|NCT01074944|Secondary|LTTP: Percentage of Participants Who Maintained a Stable Bone Criterion ,Hemoglobin Level, Platelet Count, Liver Volume and Spleen Volume at 1 Year and 2 Years|Participant were considered as stable if they met the following criteria: hemoglobin level did not decrease >1.5 g/dL from baseline for PAP, platelet count does not decrease >25% below Baseline for PAP, liver volume does not increase >20% above Baseline for PAP, spleen volume does not increase >25% above Baseline for PAP. Baseline for PAP was defined as last available assessment prior to randomization.|1 Year, 2 Years|Analysis was performed on intent to treat (ITT) population which included all participants who received at least 1 dose of eliglustat after randomization. Here ‘n’ signifies number of participants with available data at specified time points.|||percentage of participants||95% Confidence Interval|Number
2723283|NCT01074944|Secondary|LIP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26, 52 and 78|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different type of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.|||participants|||Number
2723284|NCT01074944|Secondary|LIP: Number of Participants With Bone Crises Assessment at Baseline, Weeks 26, 52 and 78|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, 2= 2 bone crises, 6= 6 bone crises, and 24= 24 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.|||participants|||Number
2723285|NCT01074944|Secondary|LIP: Number of Participants With Mobility Status (MS) at Baseline, Weeks 26, 52 and 78|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.|||participants|||Number
2723286|NCT01074944|Secondary|LIP: Mean Biomarker (MIP1-beta) Value at Baseline, Week 78|MIP1-beta biomarker was assayed from plasma.|Baseline and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||pg/mL||Standard Deviation|Mean
2723287|NCT01074944|Secondary|LIP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26, Week 52, and Week 78|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||mcg/mL||Standard Deviation|Mean
2723288|NCT01074944|Secondary|LIP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26, 52, and 78|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||nmol/hr/mL||Standard Deviation|Mean
2723289|NCT01074944|Secondary|LIP: Mean Spleen Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.|||MN||Standard Deviation|Mean
2723290|NCT01074944|Secondary|LIP: Mean Liver Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here, 'n' signifies number of participants with available data at specified time points.|||MN||Standard Deviation|Mean
2723291|NCT01074944|Secondary|LIP: Mean Platelet Count at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||platelets*10^9 /L||Standard Deviation|Mean
2723292|NCT01074944|Secondary|LIP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week, 52, and Week 78|Analysis was performed on all treated (AT) analysis set which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.|||g/dL||Standard Deviation|Mean
2723293|NCT01074944|Secondary|PAP: Total Bone Marrow Burden Score (BMB) at Baseline and Week 52|BMB Score was measured using magnetic resonance imaging (MRI), range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.|||BMB Score||Standard Deviation|Mean
2723294|NCT01074944|Secondary|PAP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26 and 52|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain during the past 4 weeks. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||participants|||Number
2723295|NCT01074944|Secondary|PAP: Number of Participants With Bone Crises at Baseline, Weeks 26 and 52|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||participants|||Number
2723296|NCT01074944|Secondary|PAP: Number of Participants With Mobility Status Asessments (MS) at Baseline, Weeks 26, and 52.|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||participants|||Number
2723297|NCT01074944|Secondary|PAP: Total Z-scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively|||Z-score||Standard Deviation|Mean
2723298|NCT01074944|Secondary|PAP: Total T-Scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||T-score||Standard Deviation|Mean
2723299|NCT01074944|Secondary|PAP: Bone Mineral Density (BMD) at Baseline and Week 52|BMD measurements of the spine and bilateral femur were acquired by dual-energy x-ray absorptiometry (DXA) scan.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.|||g/cm^2||Standard Deviation|Mean
2723300|NCT01074944|Secondary|PAP: Mean Biomarker Macrophage Inflammatory Protein-1 Beta (MIP1-beta) Value at Baseline, Weeks 26, 52|MIP1-beta biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.|||pg/mL||Standard Deviation|Mean
2723301|NCT01074944|Secondary|PAP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26 and Week 52|GL-1 on DBS biomarker was assayed from dried blood spot (DBS).|Baseline, Week 26 and week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||mcg/mL||Standard Deviation|Mean
2723302|NCT01074944|Secondary|PAP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26 and Week 52|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population which all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.|||nmol/hr/mL||Standard Deviation|Mean
2723303|NCT01074944|Secondary|PAP: Mean Liver Volume at Baseline, Weeks 26, 52||Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||MN||Standard Deviation|Mean
2723307|NCT01074944|Primary|PAP: Percentage of Participants Who Remained Stable for 52 Weeks During the PAP|Participants were considered as stable if they met all of the following criteria: 1) no more than 2 bone crisis during PAP (with no more than 1 bone crisis during either the first 6 months or the later 6 months of the period), and were free of other clinically symptomatic bone disease during the entire 52-week PAP; 2) hemoglobin level not decreased >1.5 g/dL from Baseline for PAP; 3) platelet count not decreased >25% from Baseline for PAP; 4) spleen volume (in multiples of normal [MN]) did not increase >25% from Baseline for PAP; 5) liver volume (in MN) did not increase >20% from Baseline for PAP. Baseline for PAP was defined as the last assessment prior to randomization.|PAP Baseline up to the end of PAP (Week 52)|Analysis was performed on per protocol (PP) population which included all participants who were at least 80% compliant with investigational medicinal product (IMP) dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||percentage of participants||95% Confidence Interval|Number
2723308|NCT01074931|Secondary|The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment|As so few participants withdrew from lopinavir/ritonavir treatment, durations of lopinavir/ritonavir therapy required for 25 percent, 50 percent and 75 percent of participants could not be established. The numbers of participants in each subgroup who discontinued from treatment due to an adverse event are presented.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.|||Participants|||Number
2723309|NCT01074931|Secondary|Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations|The types of adverse events reported are summarized. The presence of lipodystrophy (abnormal body fat distribution) and its location was to be recorded. However, due to an oversight, there was not a place to record the location of lipodystrophy on the case report form. Doctors used clinical judgment to rate lipodystrophy in treatment-experienced participants. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|The adverse event population includes all participants who took at least one dose of lopinavir/ritonavir (98). Lipodystrophy evaluations were performed in treatment-experienced participants (90), not treatment-naive participants (8).|||Participants|||Number
2723310|NCT01074931|Secondary|Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen|Visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The frequency with which each participant forgot to take their medication since the last visit and discontinuations of treatment and the reasons were documented at each visit and are summarized. The number of participants changing from lopinavir/ritonavir soft gel capsule to tablet are also presented. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month. Note: participants may have had multiple missed doses or therapy changes.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.|||Participants|||Number
2723311|NCT01074931|Primary|Evolution of the Tolerance Issues|At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants taking at least one dose of lopinavir/ritonavir.|||Participants|||Number
2723312|NCT01074931|Primary|Evolution of CD4 Count|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.|||cells per cmm||Standard Deviation|Mean
2723313|NCT01074931|Primary|Evolution of the HIV Viral Response|The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.|||participant|||Number
2723314|NCT01074658|Secondary|Percentage of Participants With Procedural Success|Procedural success, defined as device success with absence of in-hospital MACCE|up to 30 days|All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable.|||percentage of participants|||Number
2723315|NCT01074658|Secondary|Percentage of Participants With Device Success|"Device Success is defined as a composite of:~Successful device delivery;~Stable device placement;~Intact retrieval of delivery catheter;~Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation"|up to 24 hours|All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable.|||percentage of participants|||Number
2723316|NCT01074658|Primary|Major Adverse Cardiac & Cerebrovascular Events (MACCE)|"MACCE is defined as a composite of:~All cause mortality~Myocardial Infarction (Q-wave and non-Q-wave)~Emergent cardiac surgery or percutaneous re-intervention~Stroke~The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days."|30 days|All attempted population.|||Freedom from MACCE (%) @30days|||Number
2723768|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mg/dL||Standard Error|Mean
2723317|NCT01074554|Secondary|Change in Modified Sarcoidosis Activity and Severity Index (SASI) at Completion of Therapy.|Characterization of lesion severity was conducted using Modified Sarcoidosis Activity and Severity Index (SASI), measuring erythema, induration and desquamation. The modification was that the same scale was applied to any part of the body, instead of the face alone. The scale range is 0 (no problem) to 72 (very severe).|Baseline to 8 weeks||||units on a scale||Standard Deviation|Mean
2723318|NCT01074554|Primary|Granuloma Burden|Number of patients with a decrease in Granuloma Burden (only in those patients having granulomas present at baseline biopsy)|Baseline to 8 weeks||||participants|||Number
2723319|NCT01074554|Primary|Change in Lesion Size at the Completion of Antibiotic Therapy, Measured on a Continuous Scale; Change Will be Determined by Change in Diameter of the Lesions||Baseline to 8 weeks||||mm||Standard Deviation|Median
2723320|NCT01074502|Primary|Percentage of Patients Achieving a Clear or Almost Clear PGA at 16 Weeks||Baseline to 16 weeks|||||||
2723321|NCT01074502|Secondary|Safety of Apremilast 20 Mgs BID for 12 Weeks Will be Assessed by Evaluating Adverse Events (AEs), Vital Signs, Laboratory Evaluations and Withdrawals From the Study|Number of participants with adverse events|Baseline to 16 weeks|||||||
2723322|NCT01074502|Secondary|The Absolute Change in Lesion Counts (Total, Inflammatory, Non-inflammatory) From Baseline to Week 12||Baseline to12 weeks|||||||
2723323|NCT01074502|Primary|Mean Percentage Change From Baseline in Individual Lesion Counts (Total, Inflammatory, Non-inflammatory) at Week 12||Baseline to 12 weeks|||||||
2723324|NCT01074502|Primary|Percentage of Patients With a Minimum 2-grade Improvement in the Researcher Global Assessment (RGA) From Baseline to Week 12.|RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.|Baseline to 12 weeks|small number of subjects to be analyzed||||||
2723325|NCT01074502|Primary|Percentage of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1))|RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.|Baseline to 16 weeks|small number of subjects to analyze||||||
2723326|NCT01074463|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2723327|NCT01074463|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2723328|NCT01074463|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2723329|NCT01074450|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2723330|NCT01074450|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2723331|NCT01074450|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2723332|NCT01074437|Secondary|Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.|1, 2 and 6 months after treatment initiation|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.||||||
2723333|NCT01074437|Secondary|Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.|1, 2 and 6 months after treatment initiation|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.||||||
2723334|NCT01074437|Secondary|Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.|1, 2, and 6 months after treatment initiation|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.||||||
2723335|NCT01074437|Primary|Lesion Regression|measure of change in lesion area or volume|12 months|Insufficient enrollment for data analysis to be meaningful.||||||
2723336|NCT01074437|Primary|Compare Changes in IH Size and Vascularity for the Two Treatment Groups|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.|1, 2, and 6 months after treatment initiation|This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.||||||
2723411|NCT01074034|Secondary|Conversion Success Rate up to Three Months Post-implant|For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.|Three months post-implant||||% of conversion rates|||Number
2723337|NCT01074307|Secondary|Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26|Global assessment of CHF: The Investigator defined, graded, and recorded the participant's symptoms and signs by using a 6-point CHF scale ranging from 0 (unassessable), 1 (worsened), 2 (no change), 3 (mildly improved), 4 (moderately improved) and 5 (markedly improved).|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Units on a scale||Standard Deviation|Mean
2723338|NCT01074307|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 26|Safety analysis population included all the randomized participants who had at least one dose of the investigational product had post-dose safety data confirmed at least once by the Investigator.|||Participants|||Number
2723339|NCT01074307|Secondary|Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder||Baseline up to Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.|||Participants|||Number
2723340|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Size at Week 26|Left ventricle size was measured as systolic and diastolic Left Ventricular Internal Dimension (LVID). Diastolic dimension was measured of the left ventricle at the level of the chordae tendineae. The systolic dimension was measured as the smallest dimension between the left septal endocardium and the posterior wall endocardium during systole, whether or not the two walls were exactly apposed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Milliliter LVID||Standard Deviation|Mean
2723341|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26|LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Percent LVEF||Standard Deviation|Mean
2723342|NCT01074307|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26|6-minute Walking Test (6-MWT) distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Meter||Standard Deviation|Mean
2723343|NCT01074307|Secondary|Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)|New York Heart Association (NYHA) classification of heart failure: Class I: No limitation: ordinary physical exercise does not cause undue fatigue, dyspnea, or palpitations. Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations, or dyspnea. Class III: Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms. Class IV: Unable to carry out any physical activity without discomfort: symptoms of heart failure are present even at rest with increased discomfort with any physical activity.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.|||Percentage of participants|||Number
2723344|NCT01074307|Primary|Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. The percent change of NT-pro BNP was calculated according to the formula: N-terminal pro B-type natriuretic peptide (NT-proBNP) reduction ratio = 100*(Baseline NT-proBNP - Week 26 NT-proBNP)/Baseline NT-proBNP.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percent change||Standard Deviation|Mean
2723345|NCT01074268|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Events/100 years of patient exposure|||Number
2723412|NCT01074034|Primary|Inappropriate Shock Free Rate|Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.|Three months post-implant||||% of shock free rates|||Number
2723346|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2723347|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2723348|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2723349|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2723350|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.|||mmol/L||Standard Deviation|Mean
2723351|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.|||mmol/L||Standard Deviation|Mean
2723352|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 4 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2723353|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 5 subjects, all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2723354|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2723355|NCT01074268|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2723413|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Mental Component Summary (MCS)|The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
2723356|NCT01074255|Primary|Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy|The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).|Up to 14 days following the cessation of treatment|The Efficacy Evaluable Population consisted of participants treated with EMEND for 3 days and assessed by an investigator for efficacy. Participants were excluded from efficacy analysis for having a EMEND administration period less than 3 days (143 participants) or unavailability of final efficacy evaluation (1 participant).|||participants|||Number
2723357|NCT01074242|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis|||Percent of participants|||Number
2723358|NCT01074242|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis|||Percent of participants|||Number
2723359|NCT01074229|Secondary|24 Total Morphine Consumption|Total 24 total morphine consumption post operative.|1 day||||miligrams of morphine||Standard Deviation|Mean
2723360|NCT01074229|Primary|QoR40 on the Day After Surgery|QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.|1 day||||units on a scale||Inter-Quartile Range|Median
2723361|NCT01074216|Primary|To Achieve Target Vitamin D Level|To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks|Within 6 weeks of beginning vitamin D||||participants|||Number
2723362|NCT01074177|Secondary|Number of Participants With Biopsy Complications From Repeat Tumor Biopsies|The number of participants with biopsy complications from repeat tumor biopsies taken following disease progression. Biopsy complications are any adverse events considered to be potentially related to the biopsy.|7 days post biopsy and ≥ 30 days post-biopsy||||Participants|||Count of Participants
2723363|NCT01074177|Secondary|Median Progression-free and Overall Survival|The progression-free and overall survival times. Overall survival is measured from the start of treatment until the time of death or until the participant is lost to follow-up. Progression free survival is measured from the start of treatment until the time of progression, death, or until the participant is lost to follow-up (whichever occurs first). Progression is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.|start of treatment, at the time of disease progression, time of death||||Months||95% Confidence Interval|Median
2723364|NCT01074177|Secondary|Response Rate|"The number of participants with either a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)~CR: Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Baseline and then after the end of every two 28 day cycles until treatment is discontinued; median duration of followup of 19.3 months||||participants|||Number
2723365|NCT01074177|Primary|Number of Participants That Have a T790M Mutation on Their Progression Biopsy.||At the time of disease progression (median duration of 11.4 months from start of treatment)|The 14 participants that experienced disease progression and were also eligible to be biopsied.|||Participants|||Count of Participants
2723366|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the lichenification subscale score, lichenification is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
2723367|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the excoriation subscale score, excoriation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
2723368|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the infiltration/papulation subscale score, infiltration/papulation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
2723369|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the erythema subscale score, erythema is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
2723370|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining area subscale score, the percent area of skin involvement is determined and assigned a score of 0 to 6, where 0 correlates with no skin involvement, 1 represents < 10% skin involvement, 2 represents 10-29% skin involvement, 3 represents 30-49% skin involvement, 4 represents 50-69% skin involvement, 5 represents 70-89% skin involvement, and 6 represents 90-100% skin involvement. Possible scores range from 0 to 6, where 0 correlates with better disease severity and 6 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
2723371|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and 4 weeks||||units on a scale||Full Range|Mean
2723372|NCT01074164|Primary|Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score|"The VAS score assesses itch intensity in subject's with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled Least Itch, and the right boundary vertical line is labeled Worst Itch. Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity."|Baseline and 4 weeks||||centimeters||Full Range|Mean
2723373|NCT01074125|Secondary|Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment|proportion was calculated separately for each treatment arm|Baseline and day 28|Intent-to-Treat|||% of Participants|||Number
2723374|NCT01074125|Secondary|Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment|Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.|Baseline and day 28|Intent-to-Treat, includes only subjects that had both baseline and end of study actual values|||mg/dL||Standard Deviation|Mean
2723375|NCT01074125|Primary|Change in Serum Phosphorus From Baseline to End of Treatment|Mean change from baseline was calculated separately for each treatment arm (LOCF)|Baseline and day 28|Intent to Treat (ITT) Population|||mg/dL||Standard Deviation|Mean
2723376|NCT01074099|Primary|Safety|as measured by frequency and severity of adverse events|through 1 Year post tx||||participants|||Number
2723377|NCT01074099|Primary|Change in Cardiac Status (Classification)|A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation|Through 12 months post treatment|Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.||||||
2723414|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Physical Component Summary (PCS)|The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
2723378|NCT01074047|Secondary|Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days|Safety population includes those enrolled in the extension phase who received at least one dose of study drug.|||participants|participants||Number
2723379|NCT01074047|Secondary|HRU: Rate of Transfusions Per Patient Year|HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||transfusions per patient year|||Number
2723380|NCT01074047|Secondary|HRU: Number of Participants Receiving Transfusions|Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||participants|||Number
2723381|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||hospitalizations per patient year|||Number
2723382|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||participants|||Number
2723383|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723384|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723437|NCT01073943|Other Pre-specified|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
2723385|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723386|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723387|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723388|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723389|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723390|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723438|NCT01073943|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.|||participants|||Number
2723391|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723392|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723393|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723394|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. The analysis included 157 from the azacitidine group and 134 in the CCR group, a smaller number than the ITT population.|||units on a scale||Standard Deviation|Mean
2723395|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723396|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723439|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723397|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723398|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to End of Study; at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723399|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. .|||units on a scale||Standard Deviation|Mean
2723400|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723401|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723402|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 3; at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
2723403|NCT01074047|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017|Safety population = all randomized participants who received at least 1 dose of study drug and had 1 post-dose safety assessment. Because the BSC only regimen consisted of blood products or antibiotics given as needed, those assigned to BSC only were included in the safety population if they had at least 1 post-randomization safety assessment.|||participants|||Number
2723404|NCT01074047|Secondary|Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.|The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||participants|||Number
2723405|NCT01074047|Secondary|Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates|The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.|Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.|Includes those who achieved a CR or CRi and assessed by the IRC; numbers of ITT participants in each treatment group|||months||95% Confidence Interval|Median
2723406|NCT01074047|Secondary|Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)|A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||percentage of participants|||Number
2723407|NCT01074047|Secondary|Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)|Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.|Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months|Participants who achieved a CR or CRi|||months||95% Confidence Interval|Median
2723408|NCT01074047|Secondary|Event-free Survival (EFS)|Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.|Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||months||95% Confidence Interval|Median
2723409|NCT01074047|Secondary|One-year Overall Survival Rate|Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|From Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||percentage of participants||95% Confidence Interval|Number
2723410|NCT01074047|Primary|Kaplan-Meier Estimates for Overall Survival|Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||months||95% Confidence Interval|Median
2723415|NCT01074008|Other Pre-specified|Change From Baseline in EQ-5D (3 Level) Health Index Score|The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
2723416|NCT01074008|Other Pre-specified|Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score|The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
2723417|NCT01074008|Other Pre-specified|Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score|The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.|Baseline up to Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
2723418|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.|||participants|||Number
2723419|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.|||participants|||Number
2723420|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.|||participants|||Number
2723421|NCT01074008|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and have at least one post-baseline measurement of HCV RNA levels.|||percentage of participants|||Number
2723422|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
2723423|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
2723424|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2723425|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
2723426|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
2723427|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2723428|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
2723440|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723429|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
2723430|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2723431|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
2723432|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
2723433|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2723434|NCT01074008|Secondary|Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.|Baseline and Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and at least one post-baseline measurement of HCV RNA levels.|||percentage of participants|||Number
2723435|NCT01074008|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.|Week 4|All participants who received at least one dose of study drug and had at least one post-baseline HCV RNA value were included in this efficacy analysis.|||percentage of participants|||Number
2723436|NCT01074008|Primary|Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment|Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.|Prior to dosing on Day 1 to before the morning dose on Day 4|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||log10 IU/mL||Standard Deviation|Mean
2723441|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723442|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723443|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723444|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723445|NCT01073943|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
2723446|NCT01073943|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
2723447|NCT01073930|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.|||participants|||Number
2723448|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723449|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723450|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723451|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723734|NCT01071317|Secondary|Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale|Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.|1 month after study enrollment|2 patients in each group were lost to followup. One patient in the Typical Care group did not answer the question|||Participants|||Count of Participants
2723452|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723453|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
2723454|NCT01073930|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
2723455|NCT01073930|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
2723456|NCT01073865|Secondary|Oestradiol (E2) Serum Concentrations at 24 Weeks|E2 serum concentrations (pg/mL) at 24 weeks|24 weeks after the first dosing|Full Analysis Set|||pg/mL||Standard Deviation|Mean
2723457|NCT01073865|Secondary|Number of Responders at 24 Weeks|Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.|24 weeks after the first dosing|Full Analysis Set (patients without measurable disease at baseline were excluded from analysis)|||Participants|||Count of Participants
2723458|NCT01073865|Primary|Number of Patients With Progression-free Survival (PFS) at 24 Weeks|A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.|24 weeks after the first dosing|Full Analysis Set|||Participants|||Count of Participants
2723459|NCT01073657|Primary|"Supported Education Process Measure"|"Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the Supported Education Process Measure (Corrigan, 2009)."|6 months|Comparison of means|||number of quarter hours||Standard Deviation|Mean
2723460|NCT01073631|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.|Baseline (Day 1) up to 2.1 Years|ITT; N=number of participants evaluated for mycological response.|||Percentage of participants|||Number
2723461|NCT01073631|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2.1 Years|Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.|||Percentage of participants|||Number
2723462|NCT01073618|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed.|Baseline (Day 1) up to 2 years|ITT; N=number of subjects evaluated for mycological response.|||percentage of participants|||Number
2723475|NCT01073605|Secondary|Annual Growth Rate Standard Deviation Score (SDS)|Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||SDS||Standard Deviation|Mean
2723463|NCT01073618|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2 years|Safety population: participants received at least 1 dose of study drug for the approved indication (=Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related parameters at least once.|||percentage of participants|||Number
2723464|NCT01073605|Secondary|Number of Subjects Reaching Puberty|The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.|Baseline, 1 to 6 years|Safety population. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years. Started = started puberty; Not Started = not started puberty yet as per Tanner scale.|||participants|||Number
2723465|NCT01073605|Secondary|Chronological Age at Onset of Puberty|Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.|Onset of puberty|Safety population. Number of participants analyzed = number of subjects who started puberty by the end of the study.|||Years||Standard Deviation|Mean
2723466|NCT01073605|Secondary|Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio|Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.|1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.|||ratio||Standard Deviation|Mean
2723467|NCT01073605|Secondary|Change From Baseline in Bone Age|Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year|Baseline, 1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point.|||Years||Standard Deviation|Mean
2723468|NCT01073605|Secondary|Weight||Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||kg||Standard Deviation|Mean
2723469|NCT01073605|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||kg/m^2||Standard Deviation|Mean
2723470|NCT01073605|Secondary|Change From Baseline in Height (SDS)|Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||SDS||Standard Deviation|Mean
2723471|NCT01073605|Secondary|Height (SDS)|Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||SDS||Standard Deviation|Mean
2723472|NCT01073605|Secondary|Change From Baseline in Height (cm)|Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||cm||Standard Deviation|Mean
2723473|NCT01073605|Secondary|Height (cm)|Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||cm||Standard Deviation|Mean
2723474|NCT01073605|Secondary|Change From Baseline in Annual Growth Rate SDS|Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.|Baseline, 1 to 3 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.|||SDS||Standard Deviation|Mean
2723476|NCT01073605|Primary|Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm|Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}|Baseline, 2 years|All subjects who received at least 1 study dose of Genotonorm were included in the Full Analysis Set (FAS). Number of Participants Analyzed = number of subjects with change in annual growth rate at 2 years.|||cm/year||Standard Deviation|Mean
2723477|NCT01073566|Secondary|Self-reported Hypoglycemic Episodes|Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.|6 weeks|Intent to treat|||episodes|||Number
2723478|NCT01073566|Secondary|Insulin Delivery System Rating|Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.|6 weeks|Per Protocol|||units on a scale||Standard Deviation|Mean
2723479|NCT01073566|Secondary|Glucose Profiles Per Day|Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days|6 weeks|Intent to Treat|||mmol/L||Standard Error|Least Squares Mean
2723480|NCT01073566|Primary|Mean Daily Blood Glucose|Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose|6 weeks|Intent to treat|||mmol/L||Standard Error|Least Squares Mean
2723481|NCT01073462|Secondary|Number of Participants With Cardiac Disease Progression|Cardiac disease progression was determined by the Investigator.|Month 3, 6, 12, 18, and 24|Intent-to-treat|||participants|||Number
2723482|NCT01073462|Secondary|Percentage of Participants Experiencing Hospitalization|The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.|24 months|Intent-to-treat|||percentage of participants|||Number
2723483|NCT01073462|Secondary|Percentage of Participants With at Least One Concomitant Medication|"The percentage of participants with at least one concomitant medication during the course of the study, by the following types:~Phosphate binder~Epoetin~Renin-Angiotensin-Aldosterone System (RAAS) inhibitors~Cinacalcet~Other"|24 months|Intent-to-treat|||percentage of participants|||Number
2723484|NCT01073462|Secondary|Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.|Baseline to Month 24|Intent-to-treat|||percentage of participants|||Number
2723485|NCT01073462|Secondary|Percentage of Participants With at Least a 30%-Reduction in iPTH Levels|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used.|||percentage of participants|||Number
2723486|NCT01073462|Secondary|Percentage of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|"Intent-to-treat; LOCF was used. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2723487|NCT01073462|Secondary|Percentage of Participants With Hypercalcemia|Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used|||percentage of participants|||Number
2723488|NCT01073462|Primary|Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range|Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
2723489|NCT01073449|Secondary|Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|693 represents the number of patients implanted with an ICD within the whole population|||Participants||95% Confidence Interval|Number
2723490|NCT01073449|Primary|Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months||||Participants||95% Confidence Interval|Number
2723491|NCT01073449|Secondary|Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|2246 represents the number of patients in the whole population that were implanted with a PM|||Participants||95% Confidence Interval|Number
2723492|NCT01073293|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
2723510|NCT01073163|Secondary|Number of Participants With Treatment-Emergent Cardiac Disorders|Number of participants with cardiac disorders overall, with severity from grades 1 (mild) to grade 4 (severe), according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Participants may have reported more than 1 event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
2723493|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants||95% Confidence Interval|Number
2723494|NCT01073293|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint|||ELU/mL||95% Confidence Interval|Geometric Mean
2723495|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants||95% Confidence Interval|Number
2723496|NCT01073293|Primary|Percentage of Participants With a Systemic Adverse Experience|For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.|Up to 15 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
2723497|NCT01073293|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
2723498|NCT01073293|Primary|Percentage of Participants With a Repevax™ Injection-site Adverse Experience|For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
2723499|NCT01073293|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
2723500|NCT01073293|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||milli Merck Units/mL||Full Range|Geometric Mean
2723501|NCT01073267|Primary|Objective Response Rate|"Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).~Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score."|Baseline and at least 2 months|Intent to treat population.|||proportion of participants|||Number
2723502|NCT01073163|Secondary|Worst Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grades for Hematology Laboratory Tests Results Overall|Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Overall is defined as the worst postbaseline grade value for each patient and laboratory test across all cycles. Only postbaseline grades are summarized. If absolute neutrophil count (ANC) and neutrophils absolute (ABS) were both measured, the worse grade value from the two was summarized. Otherwise the worst ANC grade value or the worst neutrophils ABS grade value was summarized. WBC=white blood cell; LLN=lower limit of normal|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
2723503|NCT01073163|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at Endpoint|The investigator assessed each patient's ECOG performance status according to the ECOG scale at screening, on Day 1 of each treatment cycle, and at the end-of-treatment visit. Scale scores were: 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=dead. Any change in score to a higher value signifies worsening, and any change to a lower value signifies improvement.|End of study. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
2723504|NCT01073163|Secondary|Overview of Adverse Events|Adverse event (AE)=any untoward medical occurrence in a patient administered study drug that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. Treatment-related AEs=those that began or worsened after treatment with study drug. AE severity was graded according to the National Cancer Institute's Common Terminology Criteria for AEs (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Relationship of an AE to study drug was categorized as definite, probable, possible, unlikely, or not related. Serious AE (SAE)=one that occurred at any dose that resulted in any of the following outcomes or actions: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; or an otherwise important medical event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
2723505|NCT01073163|Secondary|Percentage of Participants With Overall Response|Overall Response was comprised of those participants who had Complete Response (CR) plus those who had Partial Response (PR), as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.|||percentage of participants||95% Confidence Interval|Number
2723506|NCT01073163|Secondary|Percentage of Participants With Complete Response (CR)|Complete response, as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.|||percentage of participants||95% Confidence Interval|Number
2723507|NCT01073163|Secondary|Rituximab Concentrations at 0.5 Hours, 24 Hours, and 7 Days Postinfusion||Day 1 of Cycle 1: prior to start of rituximab infusion, immediately postinfusion. Day 2 of Cycle 1: 15 minutes prior to the start of the bendamustine infusion. Day 7 and Day 14: anytime. Day 1 of Cycle 2: prior to start of rituximab infusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable serum concentration of rituximab.|||mcg/mL||Full Range|Median
2723508|NCT01073163|Secondary|Model-predicted Bayesian Bendamustine Clearance in the Presence of Rituximab|Boxplots of model-predicted Bayesian bendamustine clearance (CL) values in the presence of rituximab were generated based on the administered bendamustine doses, rate of infusion, and sample times.|Day 1 of Cycle 1: prior to start of bendamustine infusion, immediately postinfusion, 15 minutes and 30 minutes postinfusion. Day 2 of Cycle 1: 15 minutes prior to start of bendamustine infusion, 15 minutes, 30 minutes, 1, 3, and 5 hours postinfusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable bendamustine plasma concentration.|||L/h||Full Range|Median
2723509|NCT01073163|Secondary|Change From Baseline in QTcF at Maximum Concentration (Cmax) of Bendamustine and Its Metabolites (M3 and M4)|Results from a pharmacokinetic-pharmacodynamic model to show the relationship of the overall predicted change from Baseline in QTcF at the average Cmax of bendamustine and its metabolites M3 and M4.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|Pharmacokinetic-pharmacodynamic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG and at least 1 ECG with a time-matched plasma concentration pair.|||ms||95% Confidence Interval|Mean
2723583|NCT01072617|Primary|Adverse Events|Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.|3 weeks||||event|||Number
2723769|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||pg/mL||Standard Error|Mean
2723511|NCT01073163|Secondary|Number of Participants With New Onset ECG Waveform Morphological Changes|The core ECG laboratory cardiologist assessed all leads in the ECGs and defined morphological changes. Changes from baseline (looking at each of the 3 ECGs at Day 2 Cycle 1 individually and the ECGs at all on-treatment time points individually) were noted for the following events: atrial fibrillation or flutter; second degree heart block; third degree heart block; complete right bundle branch block; complete left bundle branch block; ST segment depression; T wave abnormalities (negative T waves only); myocardial infarction pattern; any new abnormal U waves.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.|||participants|||Number
2723512|NCT01073163|Secondary|Number of Participants With QTcF New Outlier Events at End of Infusion and 1 Hour Postinfusion|"Participants were considered to have an outlier ECG value based on the most extreme value across each of the time points. New means not present at baseline and becomes present on at least 1 on-treatment ECG time point. A participant had a new outlier event (500) if the maximum QTcF was >500 ms while their baseline was <=500 ms, or had an outlier event (480) if the maximum QTcF was >480 ms while their baseline was <= 480 ms. QTcF in the 30-60 ms or >60 ms categories were also considered outliers."|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.|||participants|||Number
2723513|NCT01073163|Secondary|Mean Change From Baseline in QTcF at 1 Hour Postinfusion|On Day 2 of Cycle 1, three ECGs were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine 1 hour postinfusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.|||ms||Standard Deviation|Mean
2723514|NCT01073163|Primary|Mean Change From Baseline in QT Interval as Corrected by the Fridericia Method (QTcF) at End of Infusion|On Day 2 of Cycle 1, three electrocardiograms (ECGs) were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine at the end of the infusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.|||milliseconds (ms)||Standard Deviation|Mean
2723515|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723516|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723517|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723831|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Monocytes|Change from baseline|Baseline and 52 week after||||percentage of Monocytes||Standard Deviation|Mean
2723832|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Lymphocytes|Change from baseline|Baseline and 52 week after||||percentage of Lymphocytes||Standard Deviation|Mean
2723518|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723519|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723520|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723521|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723522|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723523|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723524|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723731|NCT01071356|Primary|Methamphetamine Days of Abstinence : Proportion of Days Abstinent|The proportion of days abstinent from methamphetamine was represented by univariate averages at each interview of the overall adjusted longitudinal treatment effects for each of the Standard (SMI) and Intensive (IMI) conditions. For example, a baseline average of 0.55 at baseline represents that study participants were abstinent, on average 55% of the days measured.|Weekly while in treatment (9 weeks) and 4 and 6 month follow up||||proportion of days abstinent||Standard Error|Mean
2723525|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723526|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723527|NCT01072929|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2723528|NCT01072929|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2723529|NCT01072929|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2723530|NCT01072929|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.|||participants|||Number
2723531|NCT01072929|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723732|NCT01071317|Secondary|Number of Participants Who Returned to the Emergency Department for Management of Headache|We report the number of patient who returned to the emergency department for management of headache|1 month after study enrollment|Two patients in each arm were lost to followup.|||Participants|||Count of Participants
2723833|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Basophils|Change from baseline|Baseline and 52 week after||||percentage of Basophils||Standard Deviation|Mean
2723532|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723533|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723534|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723535|NCT01072929|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
2723536|NCT01072929|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
2723537|NCT01072929|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2723538|NCT01072877|Secondary|Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance|The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins).|8 weeks post treatment|Population consists of all patients who had a baseline and on-treatment assessment.|||units on a scale||Standard Error|Mean
2723539|NCT01072877|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|"The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4)."|8 weeks||||units on a scale||Standard Error|Mean
2723540|NCT01072877|Primary|Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)|"The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching).~The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).~At Visit 2/baseline, Week 8, scores were calculated"|Week 8||||units on a scale||Standard Error|Mean
2723541|NCT01072773|Secondary|Duration of Response|Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.|Duration of Study (up to 5 years)|Neither participant achieved a response. Therefore, no duration of response calculation was performed.||||||
2723542|NCT01072773|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death|Duration of Study (up to 5 years)||||Months||95% Confidence Interval|Median
2723543|NCT01072773|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause.|Duration of Study (up to 5 years)||||Months||95% Confidence Interval|Median
2723544|NCT01072773|Secondary|Number of Participants With an Organ Response.|The number of patients that acheived a response in an affected organ.|Duration on treatment (up to 12 cycles/months)||||participants|||Number
2723545|NCT01072773|Secondary|Number of Participants With Treatment Related Adverse Events.|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.~Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE~Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0."|Duration on treatment (up to 12 cycles/months)||||participants|||Number
2723546|NCT01072773|Primary|Number of Participants With a Confirmed Hematologic Response|"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of treatment (up to 12 cycles/months)||||participants|||Number
2723547|NCT01072669|Primary|Digital Micro-vascular Flow|Change in digital micro-vascular flow measured by LDPI in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks|Baseline and 12 weeks|Assuming a standard deviation of 0.40, and use of a two-sample t-test with significance level of 0.05, there will be 80% power to detect differences in the change from baseline of at least 0.65 units if moderate correlation (r=0.50) exists, and 0.45 units if strong correlation (r=0.75) exists between treated|||perfusion unit||95% Confidence Interval|Mean
2723548|NCT01072656|Secondary|Number of Patient Who Had >50% Reduction in VAS.|Patients report reduction in the VAS (Visual Analogue Scale Ranging from 0-10, 0 meaning no pain and 10 meaning worst pain imaginable) at the end of the open label phase (24 months post randomization f/u) compared to the pre-implantation baseline.|Baseline and 24 months||||Participants|||Count of Participants
2723549|NCT01072656|Secondary|Number of Participants Who Would Undergo the Procedure Again.|A positive answer from patients receiving active stimulation at the end of the open label phase of the study to the question: 'would you undergo this procedure again if you were to get the same benefits you experienced?'|End of Open Label Phase (24 months)||||Participants|||Count of Participants
2723550|NCT01072656|Secondary|Number of Participants Who Had 50% Improvement in PDI|A 50% improvement in pain related disability (as assessed by the pain disability index) at the end of the open label phase compared to the pre-implantation baseline. The PDI ranges from 0-10 with 0 equaling no disability and 10 equaling worst disability.|24 months post randomization follow up||||Participants|||Count of Participants
2723551|NCT01072656|Primary|Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)|Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, & Self-care. This is an average score of the 3 month period for each Active and Sham phase.|Blinded stimulation phase (3 Months)||||participants|||Number
2723552|NCT01072643|Secondary|Demonstrate That DEX is a Safe Sedative in Pediatric Subjects With PHTN|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.|24 hours|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.||||||
2723553|NCT01072643|Secondary|Obtain Pharmacokinetic Data in This Population|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR|6 hours|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.||||||
2723554|NCT01072643|Secondary|Quantify the Effect of DEX on PVR in Pediatric Subjects With Pulmonary Hypertension (PHTN) and Its Dependence on Baseline PVR|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR|Every individual patient will be studied over maximum of 4 hours during the dose escalation phase. This part of the study will be completed in 1 year|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR||||||
2723555|NCT01072643|Secondary|Efficacy of Sedation With DEX|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR|Subjects will participate in a dose escalation study which will define minimal effective dose that results in effective sedation in ≥ 7 out of 8 patients in that dose cohort. Maximum upto 4 hours|The study was terminated early due to increased pulmonary vascular resistance (PVR) in one subject from To-T1 reaching the level of a predetermined stopping rule. Investigators suggested that it is premature to conclude that DEX does not adversely affect PVR.||||||
2723556|NCT01072643|Primary|The Primary Endpoint Will be the Change in PVR in Wood Units|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization;|For each subject PVR will be measured by cardiac catheterization at T0 ( baseline measurement) , after DEX bolus (T1) which is given over 10 minutes and after 30 mins after start of the DEX infusion (T2) - Maximum upto 4 hours||||wood units|||Number
2723557|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723558|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723559|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723560|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723608|NCT01072344|Primary|Time to Relapse in Each Treatment Condition.|The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).|26 weeks|All 93 subjects started randomization phase of the study were included in the analysis|||weeks||Standard Deviation|Mean
2723609|NCT01072331|Primary|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)||4 weeks||||mg・h / dL||Standard Error|Least Squares Mean
2723561|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723562|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723563|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.~."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723564|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723565|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723566|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723567|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723610|NCT01072331|Secondary|Change From Baseline in Fasting Plasma Glucose||4 weeks||||mg / dL||Standard Error|Least Squares Mean
2723611|NCT01072331|Secondary|Change From Baseline in 24-h Mean Glucose||4 weeks||||mg / dL||Standard Error|Least Squares Mean
2723612|NCT01072331|Primary|Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)||4 weeks||||mg / dL||Standard Error|Least Squares Mean
2723568|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
2723569|NCT01072630|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2723570|NCT01072630|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
2723571|NCT01072630|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug.|||units on a scale||Standard Deviation|Mean
2723572|NCT01072630|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug|||participants|||Number
2723573|NCT01072630|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723574|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723613|NCT01072201|Primary|Mean Percentage of Plaque Scores|Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.|6 Months||||percentage of dental plaque||Standard Deviation|Mean
2723614|NCT01072201|Primary|Mean Pocket Depth|Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.|6 Months||||Millimeters||Standard Deviation|Mean
2723575|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723576|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
2723577|NCT01072630|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
2723578|NCT01072630|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
2723579|NCT01072630|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2723580|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - General Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment||||percentage of change||Standard Deviation|Mean
2723581|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - Negative Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment||||percentage of change||Standard Deviation|Mean
2723582|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment||||percentage of change||Standard Deviation|Mean
2723834|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Eosinophils|Change from baseline|Baseline and 52 week after||||percentage of Eosinophils||Standard Deviation|Mean
2723584|NCT01072539|Secondary|Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)|Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.|At the TOC or EOT assessment|Effectiveness Analysis Set from the prospective study phase; n refers to the total munber of participants who had evaluable data.|||Percentage of Participants|||Number
2723585|NCT01072539|Primary|Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics|Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.|From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Analysis Set.|||Percentage of Participants||95% Confidence Interval|Number
2723586|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site|"Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as effective to the treatment of Tygacil ."|At the TOC or EOT assessment|Effectiveness Analysis Set.|||Percentage of Participants||95% Confidence Interval|Number
2723587|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment|"Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as effective to the treatment of Tygacil ."|At the TOC or EOT assessment|Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.|||Percentage of Participants||95% Confidence Interval|Number
2723588|NCT01072539|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs|"All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer."|From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Anaysis Set|||Percentage of Participants|||Number
2723589|NCT01072526|Other Pre-specified|Change in Severity of Ocular Discomfort|This will be calculated using a composite score of the primary and secondary outcome measures.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
2723590|NCT01072526|Secondary|Change in Schirmer Tear Test With Anesthesia Result|Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
2723591|NCT01072526|Secondary|Change in Fluorescein Staining Scale|Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
2723592|NCT01072526|Secondary|Change in Tear Film Breakup Time|Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
2723593|NCT01072526|Primary|Change in Ocular Surface Disease Index (OSDI)|Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.|Start of treatment, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
2723594|NCT01072500|Secondary|Persistent Mobility Disability (Assessed Every 6 Months)|The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.|Median 2.7 years/Average 2.6 years||||participants|||Number
2723615|NCT01072201|Primary|Bleeding on Probing|Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.|6 months||||Percentage of bleeding sites||Standard Deviation|Mean
2723835|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Platelet Count|Change from baseline|Baseline and 52 week after||||*10000/μl||Standard Deviation|Mean
2723595|NCT01072500|Primary|Major Mobility Disability, Defined as Incapacity to Walk 400 Meters|The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.|Median 2.7 years/Average 2.6 years||||participants|||Number
2723596|NCT01072448|Secondary|Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)|An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|End of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2723597|NCT01072448|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2723598|NCT01072409|Primary|CNC Monosyllabic Word Performance - Treated Ear|CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.|12 months||||percent correct||Standard Error|Mean
2723599|NCT01072396|Secondary|Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime|Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
2723600|NCT01072396|Secondary|Constant Work Rate (CWR) Endurance Time|CWR exercise duration calculated as the length of time of the exercise period|six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.|||seconds||Standard Error|Least Squares Mean
2723601|NCT01072396|Primary|Change From Baseline in Inspiratory Capacity (IC) at Isotime|Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.|||liter||Standard Error|Least Squares Mean
2723602|NCT01072357|Secondary|Endothelial Cell Density|Endothelial Cell Density (Assessed at Weeks 26 & 52). Measure of the number of cells present within the endothelium that are responsible for providing the cornea with nourishment.|52 Weeks||||Number of cells per millimeters squared||Standard Deviation|Mean
2723603|NCT01072357|Primary|Number of Participants With Graft Failure at Week 39 and 52|Time from surgery to overall graft failure (regardless of cause). Graft failure was monitored throughout the entire study, but only the time points at which graft failure occurred are reported below.|12 months||||Participants|||Count of Participants
2723604|NCT01072344|Secondary|Frequency of Early Study Discontinuation in Each Treatment Condition.|This is the # of subjects who discontinued the study during randomization phase due to other reasons.|26 weeks|These are responders at the end of Phase II of the study and were then randomized into Phase III of the study.|||Participants|||Count of Participants
2723605|NCT01072344|Secondary|Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.|Discontinuation emergent signs and symptoms checklist (DESS) is a patient-rated measure of the presence and severity of discontinuation symptoms occurring after medication discontinuation. %|26 weeks|These are responders at the end of Phase II of the study and then were randomized in Phase III of the study|||Participants|||Count of Participants
2723606|NCT01072344|Secondary|Frequency, Severity, and Duration of Treatment-emergent Adverse Events.|We will report the frequency, severity, and duration of treatment-emergent adverse events by treatment arm.|26 weeks|During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.|||Participants|||Count of Participants
2723607|NCT01072344|Secondary|The Proportion of Subjects in Each Treatment Condition Who Relapse.|The proportion of subjects in each treatment condition who relapsed after randomization|26 weeks|During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.|||Participants|||Count of Participants
2723763|NCT01071070|Secondary|The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)|The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)|Baseline to 12 weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
2723616|NCT01072188|Primary|Air Blast|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|Immediately after product application||||Units on a scale||Standard Deviation|Mean
2723617|NCT01072188|Primary|Hypersensitivity to Touch (Tactile)|Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.|Immediately after product application||||Units on a scale||Standard Deviation|Mean
2723618|NCT01072175|Secondary|Part D: Overall Survival (OS)|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.|From the date of first dose until date of death due to any cause (up to approximately 7 years)|ITT Population|||Months||95% Confidence Interval|Median
2723619|NCT01072175|Secondary|Part D: Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)|ITT Population|||Months||95% Confidence Interval|Median
2723620|NCT01072175|Secondary|Part D: Duration of Response as Assessed by the Investigator|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 7 years)|ITT Population. Only those participants who had CR or PR were considered.|||Months||95% Confidence Interval|Median
2723621|NCT01072175|Secondary|Part D: Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 milimeter [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the date of first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)|ITT Population|||Participants|||Count of Participants
2723622|NCT01072175|Secondary|Part D: Area Under the Concentration-time Curve Assessment of Trametinib|AUC(0-tau) after single and repeat dose of teametinib alone and in combination with dabrafenib was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, AUC(0-tau) was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng*h/mL||95% Confidence Interval|Geometric Mean
2723623|NCT01072175|Secondary|Part D: Tmax Assessment of Trametinib|The tmax of trametinib after single and repeat dose in combination with dabrafenib (DAB) was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, tmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||Hours||Full Range|Median
2723643|NCT01072175|Secondary|Part B: AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib|Area under the concentration-time curve from time zero (predose) until the last time of quantifiable concentration (AUC [0-tau]) was assessed. Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2723836|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Leucocytes|Change from baseline|Baseline and 52 week after||||/microliter(mcl)||Standard Deviation|Mean
2723624|NCT01072175|Secondary|Part D: Cmax Assessment of Trametinib|Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2723625|NCT01072175|Secondary|Part D: Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites|Area under the concentration-time curve (AUC) from pre-dose to dosing interval (AUC[0-tau]), from pre-dose to the last time of quantifable concentration (AUC[0-tau]), and from pre-dose extrapolated to infinity (AUC[0-inf]) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2723626|NCT01072175|Secondary|Part D: Tmax of Dabrafenib Metabolites|The time to Cmax (tmax) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measuered at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||Hours||Full Range|Median
2723627|NCT01072175|Secondary|Part D: Cmax of Dabrafenib Metabolites|The maximum concentration (Cmax) of dabrafenib metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2723628|NCT01072175|Secondary|Part C: Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib|Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population|||Liters (L)||95% Confidence Interval|Mean
2723629|NCT01072175|Secondary|Part C: Oral Clearance (CL/F) of Dabrafenib and Trametinib|Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population|||Liters per hour (L/hr)||95% Confidence Interval|Mean
2723630|NCT01072175|Secondary|Part C: Plasma Concentrations of Trametinib|Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng/mL||Full Range|Median
2723631|NCT01072175|Secondary|Part C: Plasma Concentrations of Dabrafenib and Its Metabolites|Plasma concentrations of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng/mL||Full Range|Median
2723632|NCT01072175|Secondary|Part C (Randomized): Overall Survival (OS)|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. When calculating overall survival, deaths following crossover were included.|From the date of randomization until date of death due to any cause (up to approximately 7 years)|ITT Population|||Months||95% Confidence Interval|Median
2723633|NCT01072175|Secondary|Part B: Pre- and Post-dose H-scores for Individual Participants|p-ERK and p-AKT, biomarkers in tumor biopsies, were assessed for participants with BRAF mutant colorectal cancer. The H-score, which is a composite score that comprises intensity and percentage of staining, is a method of assessing the amount of protein or phospho-protein present in a biopsy sample. The score is obtained by the formula: (3 * percentage of strongly staining nuclei) + (2 * percentage of moderately staining nuclei) + (percentage of weakly staining nuclei). The H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Screening and at disease progression (up to approximately 8 years)|Biomarker Population: participants with H-score data for pre- and post-biopsy pairs|||scores on a scale|||Number
2723634|NCT01072175|Secondary|Part B: Overall Survival (OS) in BRAFi Naïve Melanoma Participants|OS is defined as the interval of time between the first dose of study medication until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.|From the date of first dose until date of death due to any cause (up to approximately 8 years)|All Treated Population.|||Months||95% Confidence Interval|Median
2723644|NCT01072175|Secondary|Part A: Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib|The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.|Day 15 and Day 16|PK Population|||ng/mL||Full Range|Median
2723635|NCT01072175|Secondary|Part B: Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..|From the date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 8 years)|All Treated Population.|||Months||95% Confidence Interval|Median
2723636|NCT01072175|Secondary|Part B: Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 8 years)|All Treated Population. Only those participants who had a CR or PR were analyzed.|||Months||95% Confidence Interval|Median
2723637|NCT01072175|Secondary|Part B: Number of Participants With BRAFi-naïve Mutant Metastatic Melanoma With the Best Overall Response as Assessed by Investigator|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 milimeter [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 8 years)|All Treated Population|||Participants|||Count of Participants
2723638|NCT01072175|Secondary|Part B (Analyte=GSK1120212): Tmax Assessment of Trametinib in Combination With Dabrafenib|The tmax is defined as the time of occurrence of Cmax. The PK parameter for tmax was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.|||Hours||Full Range|Median
2723639|NCT01072175|Secondary|Part B (Analyte=GSK1120212): Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2723640|NCT01072175|Secondary|Part B (Analyte=GSK1120212): AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib|AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2723641|NCT01072175|Secondary|Part B: Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib|The tmax is defined as the time of occurenceof Cmax. Tha tmax was assessed for plasma dabrafenib (DAB) following repeat dosing of dabrafenib 75 and 150 mg BID administered in combination with trametinib. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.|||Hours||Full Range|Median
2723642|NCT01072175|Secondary|Part B: Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma dabrafenib (DAB) following repeat dosing of DAB administered in combination with trametinib (T). The trough concentration is defined as the plasma level of a pharmaceutical product measured just before the next dose. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2723837|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and 52 week after||||g/dL||Standard Deviation|Mean
2723645|NCT01072175|Primary|Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|ATP Population|||Participants|||Number
2723646|NCT01072175|Primary|Part D: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range|"For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject Decreased to Low and Increase to High during the post-baseline period. Only descriptive analysis."|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723647|NCT01072175|Primary|Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline|Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723648|NCT01072175|Primary|Part D: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range|"For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject Decreased to Low and Increase to High during the post-baseline period. Only descriptive analysis."|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723649|NCT01072175|Primary|Part D: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline|Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723650|NCT01072175|Primary|Part D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|ATP Population|||Participants|||Count of Participants
2723651|NCT01072175|Primary|Part D (Analyte=GSK2118436): AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib|The PK parameters were determined for area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration AUC (0-tau) and from time zero (pre-dose) extrapolated to infinite time AUC (0-inf). Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour only on Day 1) post-dose administration.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2723652|NCT01072175|Primary|Part D (Analyte=GSK2118436): Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib|tmax is defined as the time of occurenceof Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.|||Hours||Full Range|Median
2723653|NCT01072175|Primary|Part D (Analyte=GSK2118436): Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib|The PK parameter Cmax was assessed. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 1 and Day 21|PK Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed|||ng/mL||95% Confidence Interval|Geometric Mean
2723733|NCT01071317|Secondary|Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale|Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable|1 month after study enrollment|Two patients in each arm were lost-to-follow-up. One patient in Typical Care did not answer this question.|||Participants|||Count of Participants
2723654|NCT01072175|Primary|Part C (Randomized): Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|ATP Population|||Participants|||Number
2723655|NCT01072175|Primary|Part C (Randomized): Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range|"For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject Decreased to Low and Increase to High during the post-baseline period. Only descriptive analysis."|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723656|NCT01072175|Primary|Part C (Randomized): Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline|Hematology parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723657|NCT01072175|Primary|Part C (Randomized): Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range|"For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject Decreased to Low and Increase to High during the post-baseline period. Only descriptive analysis."|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|ATP Population. Only those participants who were available at the indicated time points were analyzed.|||Participants|||Count of Participants
2723658|NCT01072175|Primary|Part C (Randomized): Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline|Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723659|NCT01072175|Primary|Part C (Randomized): Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)|ATP Population|||Participants|||Count of Participants
2723660|NCT01072175|Primary|Part C (Randomized): Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR)|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 19 months)|ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
2723661|NCT01072175|Primary|Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR)|PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the BICR according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment|From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 19 months)|ITT Population|||Months||95% Confidence Interval|Median
2723838|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and 52 week after||||*10000/μl||Standard Deviation|Mean
2723662|NCT01072175|Primary|Part C (Crossover): Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)|Crossover Population|||Months||95% Confidence Interval|Median
2723663|NCT01072175|Primary|Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)|ITT Population|||Months||Full Range|Median
2723664|NCT01072175|Primary|Part C (Crossover): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)|Crossover Population: participants who were randomized to and received at least one dose of dabrafenib monotherapy, and who elected to crossover to combination therapy following disease progression while on monotherapy|||Participants|||Count of Participants
2723665|NCT01072175|Primary|Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by BICR as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 19 months)|ITT Population|||Participants|||Count of Participants
2723666|NCT01072175|Primary|Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered|||Participants|||Count of Participants
2723667|NCT01072175|Primary|Part B: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure|Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)|ATP Population|||Participants|||Number
2723668|NCT01072175|Primary|Part B: Number of Participants With Worst-case Hematology Change From Baseline With Respect to Normal Range|"For Hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject Decreased to Low and Increase to High during the post-baseline period. Only descriptive analysis."|From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723669|NCT01072175|Primary|Part B: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline|Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.|From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723670|NCT01072175|Primary|Part B: Number of Participants With Worst-case Chemistry Change From Baseline With Respect to Normal Range|"For Clinical Chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Participants with missing Baseline were assumed to be within normal range. Participants were counted twice if the subject Decreased to Low and Increase to High during the post-baseline period. Only descriptive analysis."|From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723671|NCT01072175|Primary|Part B: Number of Participants With Worst-case Chemistry Toxicity Grade Change From Baseline|Clinical Chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.|From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)|All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.|||Participants|||Count of Participants
2723672|NCT01072175|Primary|Part B: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From Baseline (Day 1) until Follow-up visit (up to approximately 8 years)|All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib|||Participants|||Count of Participants
2723673|NCT01072175|Primary|Part A: AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites|Blood samples for PK analysis of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. AUC is defined as the area under the dabrafenib concentration-time curve as a measure of drug exposure. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC (0-t) is defined as area under the concentration-time curve from time zero (pre-dose) to the last time of quantifiable concentration. Date are reported as geometric least square means.|Day 15|PK Population|||ng*hour/mL (ng*hr/mL)||95% Confidence Interval|Geometric Mean
2723674|NCT01072175|Primary|Part A: Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib|Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 15|Pharmacokinetic (PK) Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed|||Nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2723675|NCT01072149|Secondary|Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period|Change from period Baseline in 0-25 hour serial FEV1 (0 to 25 hours) over Period Days 28-29 was measured. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Analysis was performed using a mixed effects repeated measures model with covariates of period treatment group, period Baseline, mean Baseline, period and time after dosing (nominal), in addition to time after dosing by period Baseline, time after dosing by mean Baseline, and time after dosing by period treatment interaction terms as fixed effects and participant as a random effect.|Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
2723676|NCT01072149|Secondary|Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period|Trough FEV1 is defined as the mean of the 23- and 24-hour post-dose assessments. For each treatment period, period Baseline is defined as the mean of the -30 and -5 minute measurements taken on Period Day 1. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Change from Baseline was calculated as the value at Period Day 29 minus the value at Baseline. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline, and period as fixed effects and participant as a random effect.|From Baseline to the end of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
2723764|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||beats per minute||Standard Deviation|Mean
2723677|NCT01072149|Primary|Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period|FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.|Pre-dose and the end of each 28-day treatment period (up to 19 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one dose of trial medication in any treatment period. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
2723678|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.|"Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2-3 weeks follow-up.|Received study product, met all eligibility criteria, and had complete outcome data at 2-3 weeks.|||percentage of participants|||Number
2723679|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.|"Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2 month ( Day 50-70) follow-up.|Per protocol. Received study product, met all eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.|||percentage of participants|||Number
2723680|NCT01072136|Secondary|Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.|The proportion of participants with mycoplasma genitalium at baseline who clear mycoplasma genitalium in either the vagina or cervix at their last follow-up visit.|At 2-3 weeks and 2 month (Day 50-70) follow-up.|Participants who were positive for mycoplasma genitalium in either the cervix or vagina at baseline and who met eligibility criteria and who returned for at least one of the follow-up visits.|||participants|||Number
2723681|NCT01072136|Secondary|Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 months according to mycoplasma genitalium status(positive cervical or vaginal swabs versus both negative) at 2 months.~Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas at 2-month follow-up.|||percentage of participants|||Number
2723682|NCT01072136|Secondary|Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 month follow-up according to asymptomatic bacterial vaginosis status at 2 month follow-up.~Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas or cervical mycoplasma genitalium at 2 month follow-up.|||percentage of participants|||Number
2723683|NCT01072136|Secondary|Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The proportion of participants experiencing one or more adverse events after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.|||percentage of participants|||Number
2723684|NCT01072136|Secondary|Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The number of participants experiencing PID after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.|||participants|||Number
2723931|NCT01069939|Secondary|Number of Participants With Adverse Events|Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.|Up to 70 weeks at the longest|All participants who received any study drug were included in this analysis.|||Participants|||Number
2723685|NCT01072136|Primary|Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).|The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 white blood cells per oil immersion field on cervical gram stain.|Visit 2 - 2 months (Day 50-70).|Per protocol. Received study product, met eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.|||percentage of participants|||Number
2723686|NCT01072032|Secondary|EEG Spectral Coherence Estimates|EEG coherence reflects the degree to which brain regions communicate. It is derived from calculating the degree of association between regions in specified frequency bandwidths; it is like a correlation, except that the values range from 0-1 instead of -1 to 1, so technically there are no units as it is a coefficient. Higher coherence values indicate stronger associations between regions.|3 weeks||||Coherence ratio||Standard Deviation|Mean
2723687|NCT01072032|Secondary|Functional Walking Measures|Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).|3 weeks||||cm/s||Standard Deviation|Mean
2723688|NCT01072032|Primary|Motor Control|Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)|3 weeks||||1/s^2||Standard Deviation|Mean
2723689|NCT01072006|Secondary|Neuropsychological Testing (Wechsler Test of Adult Reading)|This test provides an estimate of pre-morbid IQ, which is important to report so that the patient sample can be compared to other similar studies for comparable IQ level and so that pre-morbid IQ can be considered as a potential variable. There are 50 items that are each given a score of 1, so the range of scores is 0-50. The raw score is then converted into an estimated IQ score based on age and education. The scores reported below reflect this estimated IQ score, where normal IQ scores range from 75 as low average to 125 as high average.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.||||units on a scale||Standard Deviation|Mean
2723690|NCT01072006|Secondary|Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms|The PCL is a 17-item questionnaire that measures PTSD symptoms on a scale that ranges from 17-85 points. The total severity score is reported below. A higher score means a higher level of PTSD symptoms.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.||||units on a scale||Standard Deviation|Mean
2723691|NCT01072006|Primary|Functional Magnetic Resonance Imaging (fMRI) Correlation|Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.||||r-value|||Number
2723692|NCT01071993|Primary|Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.|Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours|48 hours|Participants signed consent; however, study was terminated prior to randomization||||||
2723693|NCT01071954|Secondary|Percentage of Participants Who Used Concomitant ITP Therapy||From baseline to the end of treatment; the median (minimum, maximum) duration of treatment was 135.0 weeks (5, 363 weeks).|Enrolled participants who received at least one dose of romiplostim.|||percentage of participants||95% Confidence Interval|Number
2723694|NCT01071954|Secondary|Percentage of Participants With a Platelet Response|Platelet response was defined as at least one platelet count ≥ 50 x 10^9/L in the absence of rescue medication during the study.|Assessed every 4 weeks for the duration of treatment; the median (minimum, maximum) duration of treatment was 135.0 weeks (5, 363 weeks).|Enrolled participants who received at least one dose of romiplostim.|||percentage of participants||95% Confidence Interval|Number
2723695|NCT01071954|Primary|Number of Participants Who Developed Antibodies to Endogenous Thrombopoietin|"Two validated assays were used to test for antibodies to endogenous thrombopoietin (TPO). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies.~Transient antibodies are those positive post-baseline but negative at the last time point tested.~Persistent antibodies were those positive at the last time point tested."|Once a year until the end of treatment and 1 week after the end of treatment; median (minimim, maximum) time on study was 34 (2, 91) months.|Enrolled participants who received at least one dose of romiplostim with available postbaseline data|||Participants|||Count of Participants
2723709|NCT01071798|Primary|HAQ Disability Index (HAQ-DI)|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle||||units on a scale||Standard Deviation|Mean
2723696|NCT01071954|Primary|Number of Participants Who Developed Antibodies to Romiplostim|"Two validated assays were used to test for antibodies to romiplostim / the thrombopoietin-mimetic peptide component of romiplostim (TMP). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies.~Transient antibodies are those positive post-baseline but negative at the last time point tested.~Persistent antibodies were those positive at the last time point tested."|Once a year until the end of treatment and 1 week after the end of treatment; median (minimim, maximum) time on study was 34 (2, 91) months.|Enrolled participants who received at least one dose of romiplostim with available postbaseline data|||Participants|||Count of Participants
2723697|NCT01071954|Primary|Duration Adjusted Rate of Treatment Emergent Adverse Events|"Exposure adjusted rate was defined as the total number of events divided by the duration of time participants were under observation.~The adverse event (AE) severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.~A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. The investigator assessed whether each adverse event was possibly related to the study drug."|From first dose of study drug until 1 week after last dose. The median (minimum, maximum) duration of treatment was 135.0 weeks (5, 363 weeks).|Enrolled participants who received at least one dose of romiplostim.|||events per 100 subject-years|||Number
2723698|NCT01071954|Primary|Number of Participants With Adverse Events|"The adverse event (AE) severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.~A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. The investigator assessed whether each adverse event was possibly related to the investigational product."|From first dose of study drug until 1 week after last dose. The median (minimum, maximum) duration of treatment was 135.0 weeks (5, 363 weeks).|Enrolled participants who received at least one dose of romiplostim.|||Participants|||Count of Participants
2723699|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|To Day 196|Safety analyis population|||participants|||Number
2723700|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|To Day 196|Safety analysis population|||participants|||Number
2723701|NCT01071915|Secondary|Cumulative Probability of no PSA Failure From Day 28 to Day 196|PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.|To Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196|||percent probability||95% Confidence Interval|Mean
2723702|NCT01071915|Secondary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196||Day 56 to Day 196|152 participants for this outcome measure is the analysis population from day 56 to day 196|||percent probability||95% Confidence Interval|Mean
2723703|NCT01071915|Secondary|Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28||To Day 28|152 participants for this outcome measure is the analysis population from day 0 to day 28|||percent||Inter-Quartile Range|Median
2723704|NCT01071915|Secondary|Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3||At day 3|Observed cases|||percent||95% Confidence Interval|Number
2723705|NCT01071915|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196||Day 28 to Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196|||percent probability||95% Confidence Interval|Mean
2723706|NCT01071798|Secondary|Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 2|Subpopulation With Two Cycles with HAQ Score|||participants|||Number
2723707|NCT01071798|Secondary|Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 1|Main Analysis Set with HAQ Score|||participants|||Number
2723708|NCT01071798|Secondary|Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)||during Cycle 1, during Cycle 2, during the trial (within 12 months)||||percentage of participants|||Number
2724290|NCT01066897|Secondary|Mesolimibic Reward Activity Baseline Differences in Depression vs Healthy Controls|Because of the small number of depressed patients and noisy/unusable data, analyses were not run.|Baseline|Because of the small number of depressed patients and noisy/unusable data, analyses were not run.||||||
2723710|NCT01071798|Primary|DAS28 Score|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity.|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle||||units on a scale||Standard Deviation|Mean
2723711|NCT01071538|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|8 weeks||||beats per minute||Standard Deviation|Mean
2723712|NCT01071538|Secondary|Pain Numeric Rating Scale (20 Item)|measure of average physical pain score range 0-20 Higher scores indicate worse outcome|8 weeks||||units on a scale||Standard Deviation|Mean
2723713|NCT01071538|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect."|8 weeks||||units on a scale||Standard Deviation|Mean
2723714|NCT01071538|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|8 weeks||||units on a scale||Standard Deviation|Mean
2723715|NCT01071538|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|8 weeks||||units on a scale||Standard Deviation|Mean
2723716|NCT01071538|Primary|Blood Pressure|Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.|8 weeks||||mm Hg||Standard Deviation|Mean
2723717|NCT01071538|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity theoretical scale range 0-60 Lower values represent better outcome|8 weeks||||units on a scale||Standard Deviation|Mean
2723718|NCT01071512|Secondary|Change Over Time in Normalized Hippocampal Volume|Measured on MRI scan|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing all treatment|||mL||Standard Deviation|Mean
2723719|NCT01071512|Secondary|Change Over Time in Normalized Thalamic Volume|Measured on MRI scan|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing all treatment|||mL||Standard Deviation|Mean
2723720|NCT01071512|Secondary|Change Over Time in Brain Parenchymal Fraction|Measured based on MRI scan on a 3T Phillips scanner. This is a measure of brain atrophy (i.e., brain volume loss) with lower values indicating greater atrophy (possible range 0-1).|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing treatment|||units on a scale||Standard Deviation|Mean
2723721|NCT01071512|Secondary|Change Over Time in Retinal Nerve Fiber Layer Thickness|Retinal Nerve Fiber Layer (RNFL) thickness was measured using spectral domain OCT scans by a trained technician. Scans were performed without pupil dilation.|Baseline, 24, 48, 72, and 96 weeks|Summary statistics are provided based on subjects completing all treatment|||micrometer||Standard Deviation|Mean
2723722|NCT01071512|Primary|Change in Cognitive Function Over Time|Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.|Baseline, 48 weeks, 96 weeks|Summary statistics are based on the 15 subjects who completed treatment|||units on a scale||Standard Deviation|Mean
2723723|NCT01071395|Secondary|Safety Monitoring Will be Operative Throughout the Study||18 months|||||||
2723724|NCT01071395|Secondary|Correlations Between Scale Values and Clinical Global Impressions-Severity (CGI-s) and Correlations Between Scale Changes and Clinical Global Impression of Change (CGI-c)||18 months|||||||
2723725|NCT01071395|Secondary|Correlations Among the Scales||18 months|||||||
2723726|NCT01071395|Secondary|If Sufficient Number Are Maintained on 200 mg/Day, Differences in Change Scores Between 200 mg/Day and 300 mg/Day Amantadine. (This Analysis Will be BL vs End of Study)||18 months|||||||
2723727|NCT01071395|Secondary|Change Score Differences Between Week 4 and 8 to Measure Stability of Scales Over Two Visits on Stable Doses of Amantadine or Placebo||18 months|||||||
2723728|NCT01071395|Secondary|Differences in Slope From Baseline (BL) to End of Study (Data Will Include the 4 Week Scores) Between Placebo and Amantadine to Determine Which Scales Demonstrate Sensitivity Across Time.||18 months|||||||
2723729|NCT01071395|Primary|The Investigators Will Assess Effect Size With Each Scale for Detecting Change From Baseline and Change Between Amantadine and Placebo; Allowing Assessment of Sensitivity and Specificity for Each Scale Based on Receiver Operator Characteristics (ROC).|Analyses of primary outcome measures tested sensitivity to change in dyskinesia (time effect) as well as sensitivity to differences in treatment effect (time-by-treatment interaction). These analyses were conducted using repeated-measures ANOVA (RM-ANOVA) or nonparametric analyses (Friedman's ANOVA with follow-up Wilcoxon tests). The RM-ANOVAs tested for changes in scale scores over baseline, week 4, and week 8 visits across the entire sample (time effect), as well as differences in these changes over time between treatment groups (time-by-treatment interaction). Effect size of time to change was compared using a partial eta-square estimate of effect size. An eta-squared less than or equal to 0.01 is considered small; 0.06 is considered medium; and, 0.14 is considered large.|18 months||||unitless|||Number
2723730|NCT01071356|Secondary|Addiction Severity Index|Addiction Severity Index - Lite (ASI) is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.|Baseline, 2-,4-, and 6-month follow up||||units on a scale||Standard Error|Mean
2723765|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mm Hg||Standard Deviation|Mean
2723735|NCT01071317|Primary|Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale|This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment|1 month after study enrollment|2 patients in each group were lost-to-followup|||units on a scale||95% Confidence Interval|Mean
2723736|NCT01071278|Secondary|Number of Participants Who Reported Adverse Events||Up to 22 weeks||||participants|||Number
2723737|NCT01071278|Primary|Number of Participants With Lipid Panel Control|Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).|From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)|Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population.|||participants|||Number
2723738|NCT01071252|Secondary|To Assess the Time to Relapse|Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.|37 weeks|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||days||95% Confidence Interval|Median
2723739|NCT01071252|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||Percentage of Participants|||Number
2723740|NCT01071252|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Response|IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||percentage of participants|||Number
2723741|NCT01071252|Primary|Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|week 13|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||percentage of participants|||Number
2723742|NCT01071200|Secondary|Number of Cycles Cancelled Due to Risk of OHSS|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.|||cycles|||Number
2723743|NCT01071200|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.|||participants|||Number
2723744|NCT01071200|Secondary|Percentage of Participants With Implantation|Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||percentage of participants|||Number
2723745|NCT01071200|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||percentage of participants|||Number
2723746|NCT01071200|Secondary|Percentage of Participants With Pregnancy||12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||percentage of participants|||Number
2723747|NCT01071200|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube.|Day 3 post-hCG (ET)|mITT population included all randomized participants who entered in the experimental phase at S8.|||embryos|||Number
2723748|NCT01071200|Secondary|Number of Obtained Embryos|Total number of obtained embryos with maximum 3 inseminated oocytes was calculated.|Day 3 post-hCG (Embryo transfer [ET])|mITT population included all randomized participants who entered in the experimental phase at S8.|||embryos|||Number
2723749|NCT01071200|Secondary|Fertilization Rate|Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3).|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||ratio||Standard Deviation|Mean
2725361|NCT01059357|Secondary|Operative Time|The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.|At time of surgery, up to 3 hours||||minutes||Standard Deviation|Mean
2723750|NCT01071200|Secondary|Mean Number of Mature Oocytes (Metaphase II)|Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|34-36 hours post-hCG (OPU)|"mITT population included all randomized participants who entered in the experimental phase at S8. Here N represents those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope."|||Metaphase II Oocytes||Standard Deviation|Mean
2723751|NCT01071200|Secondary|Mean Total Number of Retrieved Oocytes|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-36 hours post-hCG (OPU)|mITT population included all randomized participants who entered in the experimental phase at S8.|||oocytes||Standard Deviation|Mean
2723752|NCT01071200|Secondary|Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day||Baseline (S8) and hCG day|"mITT population included all randomized participants who entered in the experimental phase at S8. Here “N” represents number of participants analyzed and n represents the number of participants with plasma E2 levels at specified time points for respective treatment groups."|||picogram/milliter (pg/mL)||Standard Deviation|Mean
2723753|NCT01071200|Secondary|Mean Number of Ovarian Stimulation Days||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.|||Days||Full Range|Mean
2723754|NCT01071200|Secondary|Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.|||IU||Standard Deviation|Mean
2723755|NCT01071200|Primary|Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes||Baseline (Stimulation day 8 [S8]) until hCG day|"Modified intention-to-treat (mITT) population included all randomized participants who entered in the experimental phase at S8. Here N represents number of participants analyzed for this measure."|||IU||Standard Deviation|Mean
2723756|NCT01071096|Secondary|Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders|Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, & 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES)|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy|Number of Participants Analyzed is low due to some unusable samples and missing samples making comparison between months impossible. 5 Responders and 5 Non-Responders provided enough samples at all time points for comparisons.|||Florescent Units (FU)||Standard Deviation|Mean
2723757|NCT01071096|Secondary|Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline|Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication.|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3||||pmol/mg total protein||Standard Deviation|Mean
2723758|NCT01071096|Secondary|Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)|CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month.|Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7||||pmol/mg total protein||Standard Error|Mean
2723759|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7||||days||Standard Deviation|Mean
2723760|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7||||days||Standard Deviation|Mean
2723761|NCT01071083|Secondary|Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.|MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.|||Percentage of subjects meeting criteria|||Number
2723762|NCT01071083|Primary|Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.|Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.|||Percentage of subjects meeting criteria|||Number
2723770|NCT01071070|Secondary|The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL|The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL|Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
2723771|NCT01071070|Primary|The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels|The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values|Baseline to 12 Weeks|The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.|||participants|||Number
2723772|NCT01071044|Secondary|Clinical Global Impression (Severity)|The Clinical Global Impression (Severity) is a one-item clinician-rated measure. The item is a likert scale on which the clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.|Every visit|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2723773|NCT01071044|Secondary|Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)|The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2723774|NCT01071044|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|"The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.~Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients."|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2723775|NCT01071044|Secondary|Short Form McGill Pain Questionnaire|The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.|Every 2 weeks|All participants were included in analysis.|||Scores on a scale||Standard Deviation|Mean
2723776|NCT01071044|Secondary|Hamiliton Anxiety Inventory|The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2723777|NCT01071044|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2723778|NCT01071044|Primary|BRIEF-A|The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2723779|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
2723780|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 8|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
2723781|NCT01070979|Secondary|Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
2723782|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
2724129|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment|Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
2723783|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Hot Flush Count||Standard Error|Least Squares Mean
2723784|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
2723785|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Hot Flush Count||Standard Error|Least Squares Mean
2723786|NCT01070966|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.|Baseline and up to 5 years||||percentage change||Standard Deviation|Mean
2723787|NCT01070966|Primary|Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation|Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.|Up to 14 days after the treatment discontinuation||||Percentage of Participants|||Number
2723788|NCT01070953|Primary|Overall Efficacy Evaluation of EZETROL®|Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.|Baseline to 4 weeks|3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded|||participants|||Number
2723789|NCT01070953|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.|Baseline to 4 weeks|"3,309 subjects were analyzed for the efficacy~evaluation; 227 of the enrolled subjects did not complete the study and were excluded"|||percentage of change||Standard Deviation|Mean
2723790|NCT01070953|Primary|Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation|Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.|Up to 14 days after treatment discontinuation||||participants|||Number
2723791|NCT01070888|Primary|Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide|"Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows:~(max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))"|8 weeks||||percentage of fall in FEV1||Standard Deviation|Mean
2723792|NCT01070810|Other Pre-specified|Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency|Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L|Hospital stay, average 2 weeks||||Participants|||Count of Participants
2723793|NCT01070810|Other Pre-specified|Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency|Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L|24 hours||||nmol/L||Inter-Quartile Range|Median
2723794|NCT01070810|Secondary|APACHE II Score at 24 Hours|"APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death"|24 hours|APACHE II was not available on 6 patients in each group at 24 hour mostly because of early death.|||units on a scale||Standard Deviation|Mean
2723795|NCT01070810|Secondary|Number of Participants With Shock Reversal|Shock reversal was defined as > 24 hours off all vasopressors|Hospital stay, average 2 weeks||||Participants|||Count of Participants
2723796|NCT01070810|Primary|Lactate Level 24 Hours After the First Study Medication Dose||24 hours||||mmol/L||Inter-Quartile Range|Median
2723797|NCT01070784|Secondary|Evening FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment||||Liter(L)||Standard Deviation|Mean
2723798|NCT01070784|Secondary|Morning FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment||||Liter(L)||Standard Deviation|Mean
2723799|NCT01070784|Secondary|Evening Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment||||Liter/minute(L/min)||Standard Deviation|Mean
2723800|NCT01070784|Secondary|Morning Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment||||Liter/minute(L/min)||Standard Deviation|Mean
2723801|NCT01070784|Secondary|Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)|The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
2723802|NCT01070784|Secondary|Rescue Medication Use|The change from run-in period and daily during 52-week randomization treatment|Daily during 52-week randomization treatment||||innhalation/day||Standard Deviation|Mean
2723803|NCT01070784|Secondary|Number of COPD Exacerbations Over the Study Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment|Daily during 52-week randomization treatment||||event|||Number
2723804|NCT01070784|Secondary|Time to First COPD Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 52-week randomization treatment||||Percentage of participants|||Number
2723805|NCT01070784|Secondary|Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization||||percentage of Baseline||Full Range|Geometric Mean
2723806|NCT01070784|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization||||percentage of Baseline||Full Range|Geometric Mean
2723807|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough|There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
2723808|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness|There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
2723809|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening|There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
2723810|NCT01070784|Primary|ECG Variables - RR Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
2723811|NCT01070784|Primary|ECG Variables - QTcF Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
2723812|NCT01070784|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
2723813|NCT01070784|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
2723814|NCT01070784|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and 52 week after||||beats/minute||Standard Deviation|Mean
2723815|NCT01070784|Primary|Vital Signs- Pulse Rate|Change from baseline|Baseline and 52 week after||||beats/minute||Standard Deviation|Mean
2723816|NCT01070784|Primary|Vital Signs- Sitting Diastolic Blood Pressure(DBP)|Change from baseline|Baseline and 52 week after||||mmHg||Standard Deviation|Mean
2723817|NCT01070784|Primary|Vital Signs- Sitting Systolic Blood Pressure(SBP)|Change from baseline|Baseline and 52 week after||||mmHg||Standard Deviation|Mean
2723818|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
2723819|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
2723820|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total|Change from baseline|Baseline and 52 week after||||g/dL||Standard Deviation|Mean
2723821|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Albumin|Change from baseline|Baseline and 52 week after||||g/dL||Standard Deviation|Mean
2723822|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S- Calcium|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
2723823|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Potassium|Change from baseline|Baseline and 52 week after||||mEq/L||Standard Deviation|Mean
2723824|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Sodium|Change from baseline|Baseline and 52 week after||||mEq/L||Standard Deviation|Mean
2723825|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
2723826|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Creatinine|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
2723827|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and 52 week after||||U/L||Standard Deviation|Mean
2723828|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase|Change from baseline|Baseline and 52 week after||||U/L||Standard Deviation|Mean
2723829|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and 52 week after||||U/L||Standard Deviation|Mean
2723830|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and 52 week after||||percentage of Neutrophils||Standard Deviation|Mean
2723839|NCT01070771|Secondary|To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data.|"This compared the number of vessels in which there was a discrepant result in relation to angiographically and FFR defined significance. Angiographic significance was visually assessed by operators whereas the pressure wire provided objective data as to a narrowing's significance: an FFR reading of <0.8 indicated a significant restriction in blood flow with a recommendation for revascularisation.~The difference in indication for revascularisation of each major coronary artery was also judged according to angiogram alone compared with angiogram plus FFR dtaa."|Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.||||participants|||Number
2723840|NCT01070771|Primary|Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG)|This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.|Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.||||participants|||Number
2723841|NCT01070693|Primary|Long-term Sequelae|Any pain at five years|5 years||||percentage of participants|||Number
2723842|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723843|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723844|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants|||Number
2723845|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants|||Number
2723846|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of Participants|||Number
2723847|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants|||Number
2723848|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12|RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|At Week 4 and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.|||Participants|||Number
2723849|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.|Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.|||Participants|||Number
2723850|NCT01070550|Secondary|Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723851|NCT01070550|Secondary|Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723852|NCT01070550|Secondary|Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723853|NCT01070550|Secondary|Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|At Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723883|NCT01070329|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result, Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
2723854|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time|Modified virological response is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723855|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time|Modified virological response was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723856|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723857|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723858|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point.|||Percentage of participants||95% Confidence Interval|Number
2723859|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. n = the number of participants analyzed at a given time point.|||Percentage of participants||95% Confidence Interval|Number
2723860|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723861|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723862|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2723863|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of peginterferon alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
2723864|NCT01070394|Secondary|Psychometric Validation of AMSES|To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.|Weeks 0-12||||Cronbach's alpha coefficients|||Number
2723865|NCT01070394|Secondary|Psychometric Validation of AMRS|To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.|Weeks 0-12||||Cronbach's alpha coefficients|||Number
2723866|NCT01070394|Primary|Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)|"The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19.~Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. A score of 0-16 means Unlikely to have ADHD; a score of 17-23 Likely to Have ADHD ; 24 or greater-Highly Likely to have ADHD"|12 weeks||||units on a scale||Standard Deviation|Mean
2723867|NCT01070394|Secondary|Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist|To correlate symptom rebound through a single day (assessed via the AMRS) with a self assessment of ADHD Symptoms. A Pearson's correlation coefficient will be presented. AMRS and self assessment of ADHD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.|Baseline to Week 12||||Pearson's correlation coefficient|||Number
2723868|NCT01070394|Secondary|Change in Correlation Between AMRS and TASS|To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented. AMRS and TASS scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.|Visits 0 and 12||||Pearson's correlation coefficient|||Number
2723869|NCT01070394|Secondary|Correlation Between AMRS (In Clinic) and ADHD-RS|To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. AMRS and ADHD-RD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.|Visits 0 and 12||||Pearson's correlation coefficient|||Number
2723870|NCT01070394|Secondary|Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)|The Adult ADHD Medication Smoothness of Effect Scale (AMSES) is a 6-item, frequency-based, self-report scale that was recently developed to assess the consistency and duration of effect of ADHD medication throughout the day. The AMSES compares the effectiveness of ADHD medication shortly after dosing with the effectiveness later in the day. Respondents are asked to rate how frequently the effective-ness of their medication was the same 2 hr post-dose as it was 4, 6, 8, 10, and 12 hr post-dose on a 0 to 4 scale (0 = never, 1 = rarel, 2 = sometimes, 3 = often, 4 = very often). In addition, respondents rate how frequently the delivery of their medication was consistent and smooth throughout the day on a visual analog scale ranging from 0 (never) to 100 (very often).|Visits 0 and 12||||units on a scale||Standard Deviation|Mean
2723871|NCT01070394|Secondary|Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).|To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Scoring on the AMRS based on 38 items, each scored 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). The lowest scored units on a scale for 1 individual is 0, the highest 114. The scores reported below are Mean scores for 33 patients analyzed.|Week 0 to Week 12||||units on a scale||Standard Deviation|Mean
2723872|NCT01070381|Primary|Overall Comfort|Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2723895|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.|||Participants|||Number
2723873|NCT01070329|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline C-SSRS result.|||participants|||Number
2723874|NCT01070329|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723875|NCT01070329|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723876|NCT01070329|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine|Laboratory assessment of creatinine during the double-blind treatment phase. Normal creatinine ranges for males are 40.00 micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high). Normal creatinine ranges for females are 31.00 µmol/L (low) to 101.00 µmol/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.|||participants|||Number
2723877|NCT01070329|Other Pre-specified|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."|||kilograms (kg)||Standard Error|Least Squares Mean
2723878|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723879|NCT01070329|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."|||mm Hg||Standard Error|Least Squares Mean
2723880|NCT01070329|Other Pre-specified|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."|||beats per minute (bpm)||Standard Error|Least Squares Mean
2723881|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723882|NCT01070329|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
2723884|NCT01070329|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723885|NCT01070329|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723886|NCT01070329|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2723887|NCT01070316|Primary|Number of Participants Continuing Study Medication Over Time||Individual subjects will be assessed every 6 months for up to 48 months; aggregate analysis will take place at end of study||||participants|||Number
2723888|NCT01070316|Primary|Reduction in Seizure Frequency|The primary efficacy endpoint was the percentage of participants demonstrating a 50% or greater reduction in seizure frequency at the end of the maintenance phase (weeks 13-16) compared to baseline (weeks 1-4)|Baseline (Weeks 1-4), Week 16||||percentage|||Number
2723889|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260.|||Participants|||Number
2723890|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212.|||Participants|||Number
2723891|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152.|||Participants|||Number
2723892|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 104.|||Participants|||Number
2723893|NCT01070303|Secondary|Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248|The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point.|||Scores on a scale||Standard Deviation|Mean
2723894|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.|||Participants|||Number
2723896|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.|||Participants|||Number
2723897|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.|||Participants|||Number
2723898|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.|||Participants|||Number
2723899|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.|||Participants|||Number
2723900|NCT01070303|Secondary|Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.|||Participants|||Number
2723901|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.|||Participants|||Number
2723902|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.|||Participants|||Number
2723903|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)|CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included.|||Participants|||Number
2723904|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in Study to Week 152|The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included.|||Participants|||Number
2723905|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 .|||Participants|||Number
2723906|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.|||Participants|||Number
2723907|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212|||Participants|||Number
2723908|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.|||Participants|||Number
2723909|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included.|||Participants|||Number
2723910|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included.|||Participants|||Number
2723911|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 212|Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included.|||Participants|||Number
2723912|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.|||Participants|||Number
2723913|NCT01070303|Primary|Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included.|||Participants|||Number
2723914|NCT01070173|Primary|Acylated Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.|||pg/mL||Standard Deviation|Mean
2723915|NCT01070173|Primary|Total Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.|||pg/mL||Standard Deviation|Mean
2723916|NCT01070095|Secondary|System Uptake|Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required|During the 12 month intervention period|Number of patients for whom clinicians accessed the CDSS when actions were required based on the information entered in the questionnaire (a subset of the total intervention group). We have only presented data from the Intervention Period, as this outcome pertains to the uptake of the intervention, and is not applicable to the Baseline Period.|||Participants|||Count of Participants
2723917|NCT01070095|Secondary|Adherence Discussions|The number of patients in the intervention period in whom discussions about medication adherence took place|During the 12 month intervention period|We have only presented data from the Intervention Period, as this was not captured in the Baseline Period.|||Participants|||Count of Participants
2723918|NCT01070095|Secondary|Ratio of Rescue to Controller Medication Prescriptions|Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods|24 months||||Ratio of SABAs to controllers prescribed|||Number
2723919|NCT01070095|Secondary|Number of Practitioners Completing Feedback Questionnaires|Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)|13 months|Responding physicians. We have only presented data from the Intervention Period, as questionnaires were provided after the intervention only.|||Participants|||Count of Participants
2723920|NCT01070095|Secondary|On Treatment Analysis|Number of eligible patients to whom an asthma action plan (AAP) was delivered, when decision support was available (52 weeks), counting only intervention period visits in which patients completed the questionnaire before the appointment and the notification prompted clinicians to open the computerized clinical decision support system (CDSS) to take action|During the 12 month intervention period|Number of eligible patients with AAP delivery. This counts only patients for whom a prompt was presented to the clinician, so is a subset of the intervention population. We have only presented data from the Intervention Period, as this outcome pertains to the uptake of the intervention, and is not applicable to the Baseline Period.|||Participants|||Count of Participants
2723921|NCT01070095|Secondary|Appropriate Medication Changes|Number of eligible visits in which patients who had an appropriate medication change made (i.e. escalation for poor control, and de-escalation for good control, when ascertainable)|24 months||||Visits|Visits||Number
2723922|NCT01070095|Secondary|Medication Escalations|The number of patients with escalation of controller therapy Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control|24 months|In the measuring therapy escalation, we eliminated visits in which patients had had a controller medication escalated within the last three months (the typical duration of a therapeutic trial)|||participants|||Number
2723923|NCT01070095|Secondary|Asthma Control Assessment|"The number of patients with asthma control determined at least once, according to symptom-based criteria (control determination required meeting one or more criteria for uncontrolled asthma or all criteria for controlled asthma).~Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control"|24 months||||Participants|||Count of Participants
2723924|NCT01070095|Secondary|The Impact of the eAAPS on Patient-relevant Outcomes Including Hospitalisations, Emergency Room Visits, Unscheduled & Total Visits to the Doctor, Days Off Work/School, Nocturnal/Daytime Asthma Symptoms, Daytime Rescue Bronchodilator Use & Quality of Life.||Every 2 weeks for 6 months|Not measured due to inadequate patient outcome measurement recruitment||||||
2723925|NCT01070095|Primary|Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician|Number of eligible patients to whom an AAP was delivered by the physician during the intervention period (52 weeks) compared to the baseline period (52 weeks) Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control|24 months|Number of patients on an asthma controller medication [either inhaled corticosteroid (ICS), ICS/long-acting beta agonist (LABA), or leukotriene receptor antagonist (LTRA)] for at least 1 visit in the study period, who received an AAP, and had not received/reviewed an asthma action plan in the last 6 months (a subset of the intervention population).|||Participants|||Count of Participants
2723926|NCT01070043|Secondary|Number of Participants With Adverse Events During Double-blind Phase||8 weeks|Safety population included all patients who received at least one study medication during the study period.|||Participants|||Number
2723927|NCT01070043|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2723928|NCT01070043|Secondary|Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2723929|NCT01070043|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2723930|NCT01070043|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2723932|NCT01069939|Secondary|Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48|"The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)||||Participants|||Number
2723933|NCT01069939|Secondary|Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48|"The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of Nausea and/or Vomiting at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
2723934|NCT01069939|Secondary|Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week|"The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of abdomen enlarged feeling at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
2723935|NCT01069939|Secondary|Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48|"The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of anorexia at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
2723936|NCT01069939|Secondary|Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.|"The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of heartburn at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
2723937|NCT01069939|Secondary|Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48|"The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of epigastric pain at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
2723938|NCT01069939|Secondary|Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.|Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.|12, 24, 36 and 48 weeks|Patients with endoscopy were included in the analyses at 12, 24, 36 and 48 weeks after randomisation.|||Participants|||Number
2723939|NCT01069939|Secondary|Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48|Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.|Up to 48 weeks (Baseline to last measurement)|Participants who had LANZA scores at both baseline and post-dose were included into this analysis.|||Scores on a scale||Standard Deviation|Mean
2723940|NCT01069939|Primary|Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.|Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.|From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)|Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment.|||Participants|||Number
2723941|NCT01069900|Secondary|Bacteriological Response at the End of Treatment (EOT) Visit|Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723950|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
2725614|NCT01056380|Primary|Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)||Up to 28 days|All subjects with laboratory confirmed influenza who took at least one dose of study medication.|||hours||Inter-Quartile Range|Median
2723942|NCT01069900|Secondary|Clinical Response at the End-of-Treatment (EOT) Visit|Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723943|NCT01069900|Secondary|Bacteriological Response at a 'During Therapy' Visit|Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723944|NCT01069900|Secondary|Clinical Response at a 'During Therapy' Visit|"Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.~'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported."|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723945|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported|28 to 42 days|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723946|NCT01069900|Secondary|Bacteriological Response at Test-of-Cure (TOC) Visit|"Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.~'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported."|28 to 42 days|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723947|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.|28 to 42 days|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
2723948|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Percentage of subjects|||Number
2723949|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Percentage of subjects|||Number
2724026|NCT01069341|Secondary|Presence of Proliferative Diabetic Retinopathy (PDR)|Presence of proliferative diabetic retinopathy by fluorescein angiogram|at month-12|All subjects' data was analyzed, no subjects were excluded|||participants|||Number
2723951|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
2723952|NCT01069900|Secondary|QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
2723953|NCT01069900|Secondary|QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QRS interval represents the time it takes for ventricular depolarization to occur. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
2723954|NCT01069900|Secondary|RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The RR interval refers to the respective time interval in the Electrocardiogram. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
2723955|NCT01069900|Secondary|PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
2723956|NCT01069900|Secondary|Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Beats per minute (bpm)||Standard Deviation|Mean
2723957|NCT01069900|Secondary|Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term|"Musculoskeletal adverse events were classified as following SOCs (preferred terms): injury, poisoning and procedural complications (forearm fracture, joint injury, ligament sprain, muscle strain) musculoskeletal and connective tissue disorders (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms."|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Percentage of subjects||95% Confidence Interval|Number
2723958|NCT01069900|Primary|Number of Subjects With Musculoskeletal Adverse Events||All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Subjects|||Number
2723959|NCT01069900|Primary|Number of Subjects With Clinical Cardiac Adverse Events||Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Subjects|||Number
2723960|NCT01069900|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Subjects|||Number
2723961|NCT01069861|Other Pre-specified|Duration of Study Medication|The duration of the infusion was determined as per investigator's discretion up to Day 7 or Day 14.|Baseline up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723962|NCT01069861|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320)||Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723963|NCT01069861|Secondary|Population Pharmacokinetics of Sildenafil|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion|||||||
2725615|NCT01056341|Secondary|Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.|Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits|6 months|||||||
2723964|NCT01069861|Secondary|Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO])|Time from start of treatment up to introduction of standard therapy. If participants did not receive standard therapy within 14 days after initiation of the study treatment, then Day 14 was the censoring time.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723965|NCT01069861|Secondary|Duration of Mechanical Ventilation|The number of days from the start to the stop of mechanical ventilation, if multiple ventilations occurred during the follow-up, the sum of the duration of each ventilation was used for analyses. Mechanical ventilation was defined as use of mechanical assistance or replacement of spontaneous breathing.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723966|NCT01069861|Secondary|Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12|The ratio of partial pressure of arterial oxygen and fraction of inspired oxygen is a comparison between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723967|NCT01069861|Secondary|Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12|Differential oxygenation saturation between preductal and postductal sites as measured by pulse oximetry. A difference of greater than (>) 5 percent (%) to 10% in saturation indicates right-to-left shunt through the ductus arteriosus. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723968|NCT01069861|Secondary|Change From Baseline in Oxygenation Index at Hour 6 and 12|Oxygenation Index (OI) was calculated as the product of fraction of inspired oxygen (FiO2) and Mean Airway Pressure divided by partial pressure of oxygen in arterial blood [(FiO2*Mean Airway Pressure)/PaO2] measured in centimeter of water/millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level in the arterial blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723969|NCT01069861|Primary|Number of Participants With Abnormal Laboratory Data|Criteria for potentially clinically significant (PCS) laboratory values: hematocrit 29.2 percent (%); white blood cell (WBC) count 5.0*10^3, lymphocyte absolute 0.88*10^3, total neutrophils absolute 12.07*10^3, eosinophils absolute 0.50*10^3 per cubic millimeter (/mm^3); calcium 6.8 milligram/deciliter (mg/dL); venous bicarbonate 47.0 milliequivalent/liter (meq/L).|Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14)|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723970|NCT01069861|Primary|Number of Participants With Adverse Events (AEs) Based on Severity|"AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE:AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent/significant disability/incapacity; congenital anomaly. Severity criteria: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function and severe=interferes significantly with participant's usual function."|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723971|NCT01069861|Primary|Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO)|Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment.|From start of infusion (baseline) up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
2723972|NCT01069627|Secondary|Time to Overall Response of CR or PR - Time to Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; only participants with a response of CR or PR were included in the analysis.|||days||Standard Deviation|Mean
2723973|NCT01069627|Secondary|Time to Overall Response of CR or PR - Percentage of Participants With an Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
2723974|NCT01069627|Secondary|Time to CR - Time To Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis.|||days||Standard Deviation|Mean
2724027|NCT01069341|Secondary|Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)|Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12|months 3, 7 and 12|All subjects' data was analyzed, no subjects were excluded|||participants|||Number
2723975|NCT01069627|Secondary|Time to CR - Percentage of Participants With an Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
2723976|NCT01069627|Secondary|TTF - Time to Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||days||95% Confidence Interval|Median
2723977|NCT01069627|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
2723978|NCT01069627|Secondary|OS - Time to Event|The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population|||days||95% Confidence Interval|Median
2723979|NCT01069627|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population|||percentage of participants|||Number
2723980|NCT01069627|Secondary|Duration of Stable Disease - Time to Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the analysis.|||days||95% Confidence Interval|Median
2723981|NCT01069627|Secondary|Duration of Stable Disease - Percentage of Participants With an Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the anlaysis.|||percentage of participants|||Number
2723982|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Time to Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.|||days||95% Confidence Interval|Median
2723983|NCT01069627|Primary|Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)|The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants||95% Confidence Interval|Number
2723984|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Percentage of Participants With an Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.|||percentage of participants|||Number
2723985|NCT01069627|Secondary|Duration of CR - Time to Event|The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis|||days||95% Confidence Interval|Median
2724028|NCT01069341|Primary|Adverse Event (AE)|Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).|first 12 months|All subjects' data was analyzed, no subjects were excluded|||participants|||Number
2723986|NCT01069627|Secondary|Duration of CR - Percentage of Participants With an Event|Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR were included in the analysis.|||percentage of participants|||Number
2723987|NCT01069627|Secondary|TTP - Time to Event|TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||days||95% Confidence Interval|Median
2723988|NCT01069627|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
2723989|NCT01069627|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form and were assigned a study patient number; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants||95% Confidence Interval|Number
2723990|NCT01069562|Secondary|INTRA OPERATIVE PHENYLEPHRINE USED|The amount of phenylephrine used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||.µg/kg||Standard Deviation|Mean
2723991|NCT01069562|Secondary|Intra Operative Adrenaline Used|The amount of adrenaline used during the procedure|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||µg/kg||Standard Deviation|Mean
2723992|NCT01069562|Secondary|Fentanyl Used|The total amount of fentanyl that was used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||µg/kg||Standard Deviation|Mean
2723993|NCT01069562|Secondary|Intra-operative Awareness|The number of patients who were able to recall the intra-operative events when assessed postoperatively. This was assessed by a structured protocol|3 days (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||participants|||Number
2723994|NCT01069562|Secondary|Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of time||Standard Deviation|Mean
2723995|NCT01069562|Secondary|Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline|The duration of time heart rate remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of time||Standard Deviation|Mean
2723996|NCT01069562|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of BIS||Standard Deviation|Mean
2723997|NCT01069562|Secondary|Median Absolute Performance Error (MDAPE)|The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage deviation of absolute BIS||Standard Deviation|Mean
2723998|NCT01069562|Secondary|Median Performance Error (MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during isoflurane anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage deviation of BIS from target||Standard Deviation|Mean
2724057|NCT01069003|Primary|Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)||||Percentage of participants|||Number
2723999|NCT01069562|Primary|Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50|The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of time||Standard Deviation|Mean
2724000|NCT01069523|Secondary|Clinical Global Impression- Improvement|Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse|Week 4 of study||||units on a scale||Standard Deviation|Mean
2724001|NCT01069523|Primary|Dupaul ADHD Rating Scale|54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.|Baseline and Follow up||||units on a scale||Standard Deviation|Mean
2724002|NCT01069510|Secondary|Procollagen 3 NT Peptide||12 months|Limited samples obtained from participants|||mcg/l||Standard Deviation|Mean
2724003|NCT01069510|Secondary|6-minute Walk Distance|distance walked recorded in meters after 6 minutes on flat ground|12 month||||meters||Standard Deviation|Mean
2724004|NCT01069510|Primary|Extracellular Volume Fraction|extracellular volume fraction measured by T1 mapping with MRI|12 month||||percentage of myocardium||Standard Deviation|Mean
2724005|NCT01069484|Secondary|Urinary Incontinence (Positive Pad Test)|"Urinary incontinence assessed by pad test, as described by Mørkved and Bø (1997). The cutoff value for a positive test was 2 gram.~After voiding, the women drank one litre of water. Thirty minutes later they wore a pre-weighted pad and performed a stress test as follows:~Jumping up and down with maximal intensity for 30 seconds.~Jumping with the legs in alternate abduction and adduction (Jumping Jacks) with maximal intensity for another 30 seconds.~Coughing as hard as possible three times. As in the study by Mørkved and Bø (1997), a positive pad-test was set to a cut-off of 2 gram of leakage."|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.|||participants|||Number
2724006|NCT01069484|Primary|Urinary Incontinence (Prevalence)|Urinary incontinence was assessed by The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form questionnaire, www.iciq.net). Women were considered as incontinent if they reported to leak urine (yes/no) at any frequency.|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.|||participants|||Number
2724007|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)|"The CDAI was calculated with the equation:~CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104)."|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||units on a scale||Standard Deviation|Mean
2724008|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||units on a scale||Standard Deviation|Mean
2724009|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)|Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||units on a scale||Standard Deviation|Mean
2724010|NCT01069419|Primary|Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6|"The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.~For the analysis, DAS28 values were categorized into the following groups:~DAS28 < 2.6: clinical remission~DAS28 from 2.6 to ≤ 3.2: low disease activity~DAS28 from > 3.2 to 5.1: moderate disease activity~DAS28 > 5.1: high disease activity"|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||percentage of participants||95% Confidence Interval|Number
2724011|NCT01069354|Secondary|Assess Subject Preference to Pain|"2 questions were asked of 101 subjects: 1) Was one treatment less painful than the other? and 2) Was the difference in pain levels significant enough to affect your preference for one treatment over the other?~Only those participants responding yes to these 2 questions about pain and preference for treatment are reported in the table below."|Immediately after injection (Time 0)||||"participants responding yes"|||Number
2724012|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|4 weeks post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
2724013|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|2 weeks post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
2724014|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|1 week post injection|Two subjects missed their Week 1 visit.|||units on a scale||Standard Deviation|Mean
2724015|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|60 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
2724016|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|45 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
2724017|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|30 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
2724018|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|15 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
2724019|NCT01069354|Secondary|Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS|"In this split-face study, a clinically meaningful difference in pain was defined as a 2-cm reduction (i.e., subject reports at least 2-cm less pain on a 10-cm VAS) in the Radiesse® Mixed with Lidocaine NLF when compared to the Radiesse® without Lidocaine NLF."|Immediately after injection (Time 0)|In this split-face study, participants received both treatments (i.e., 1 NLF with Radiesse Mixed with Lidocaine and 1 NLF with Radiesse without Lidocaine). Results are presented as the number of participants reporting at least a 2-cm lower pain VAS score in the Radiesse Mixed with Lidocaine NLF when compared to the Radiesse without Lidocaine NLF.|||participants|||Number
2724020|NCT01069354|Primary|Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)|"Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain).~In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero."|Immediately after injection (Time 0)||||units on a scale|Nasolabial folds|Standard Deviation|Mean
2724021|NCT01069341|Secondary|Mean Change in Intraocular Pressure (IOP)|Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.|at months-3,7, and 12|All subjects' data was analyzed, no subjects were excluded|||mmHg||Standard Deviation|Mean
2724022|NCT01069341|Secondary|Mean Number of PRP Laser Treatments|Mean number of PRP laser treatments required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded|||PRP Laser treatments||Standard Deviation|Mean
2724023|NCT01069341|Secondary|Mean Number of Ranibizumab Injections|Mean number of ranibizumab injections required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded|||Number injections||Standard Deviation|Mean
2724024|NCT01069341|Secondary|Mean Time to Re-treatment|Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)|first 12 months|All subjects' data was included|||months||Standard Deviation|Mean
2724025|NCT01069341|Secondary|Macular Volume|Macular volume (millimeters cubed [mm3]) by Stratus OCT|at months-1,3,7, and 12|All subjects' data was analyzed, no subjects were excluded|||Macular volume (millimeters cubed)||Standard Deviation|Mean
2724029|NCT01069315|Secondary|Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure)|Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months.|one year|Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|||units on a scale||Standard Deviation|Mean
2724030|NCT01069315|Secondary|Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure)|Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|one year|Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|||units on a scale||Standard Deviation|Mean
2724031|NCT01069315|Secondary|Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution).|Solution and pressure were analyzed separately for this outcome. The EQ-5D summary score ranges from 0 to 1. Higher scores indicate that a person has a better health-related quality of life, while lower scores indicate worse health-related quality of life. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|one year|Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|||units on a scale||Standard Deviation|Mean
2724032|NCT01069315|Secondary|Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution).|Solution and pressure were analyzed separately for this outcome. The SF-12 summary scores (PCS-12 and MCS-12) ranges from 0 to 100. Higher scores indicate that a person has better health status, while lower scores indicate poorer health status. Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|1 year|Please note that the values reported are mean differences in scores from baseline (pre-injury) to 12 months per arm.|||units on a scale||Standard Deviation|Mean
2724033|NCT01069315|Secondary|The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.||1 year||||Participants|||Count of Participants
2724034|NCT01069315|Primary|The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).||one year||||Participants|||Count of Participants
2724035|NCT01069289|Secondary|St George's Respiratory Questionnaire (SGRQ) Total Score|The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
2724036|NCT01069289|Secondary|Use of Rescue Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||inhalations/day||Standard Deviation|Mean
2724037|NCT01069289|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
2724038|NCT01069289|Secondary|Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
2724039|NCT01069289|Secondary|Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
2724040|NCT01069289|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Nights with symptoms||Standard Deviation|Mean
2724041|NCT01069289|Secondary|Evening Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter (L)||Standard Deviation|Mean
2724042|NCT01069289|Secondary|Morning Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter (L)||Standard Deviation|Mean
2724043|NCT01069289|Secondary|Total Number of Day With Exacerbation|Total number of days with COPD exacerbation for each treatment group|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||days|||Number
2724044|NCT01069289|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter/minute (L/min)||Standard Deviation|Mean
2724045|NCT01069289|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter/minute (L/min)||Standard Deviation|Mean
2724046|NCT01069289|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||event|||Number
2724047|NCT01069289|Secondary|Percentage of Participants With Exacerbations|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of participants|||Number
2724048|NCT01069289|Secondary|1 Hour Post-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
2724049|NCT01069289|Secondary|Pre-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
2724050|NCT01069289|Secondary|1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
2724051|NCT01069289|Primary|Pre-dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
2724052|NCT01069185|Secondary|Mechanical Ventilation Length as Days.|Number of days under mechanical ventilation during ICU hospitalization length|Every day while patient really is intubated.||||Days||Inter-Quartile Range|Median
2724053|NCT01069185|Primary|Primary Composite End Point|All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.|Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .||||event|suctioning||Number
2724054|NCT01069172|Secondary|Cumulative Dissipated Energy (CDE)|"CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:~CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)~0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification."|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of CDE was done by eye group.|||CDE||Standard Deviation|Mean
2724055|NCT01069172|Primary|Deviation From Intended Capsulotomy Diameter|Capsulotomy diameter measured during surgery for both the experimental and control groups.|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of capsulotomy size was done by eye group.|||μm||Standard Deviation|Mean
2724056|NCT01069120|Primary|To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)||During two 4 month treatment periods|||||||
2724058|NCT01069003|Primary|Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects|"All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)~Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers~Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause"|Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)||||percentage of participants|||Number
2724059|NCT01069003|Primary|Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)||||Percentage of participants|||Number
2724060|NCT01068964|Primary|The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4|The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.|Baseline, Week 4|Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2724061|NCT01068912|Primary|Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza|"Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. Alleviated was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours."|22 weeks|The primary analysis population for efficacy analyses was the ITTI Population (N=333), defined as all patients who received at least 1 dose of study drug with any available efficacy data after randomization and who tested positive for influenza A or B by PCR assay or culture tests on Day 1 using determinations.|||hours||95% Confidence Interval|Median
2724062|NCT01068860|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks|An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline, 4 weeks|Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment.|||participants|||Number
2724063|NCT01068860|Secondary|Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks|"Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||nmol/L||Standard Error|Least Squares Mean
2724064|NCT01068860|Secondary|Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks|Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/L||Standard Error|Least Squares Mean
2724065|NCT01068860|Secondary|Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks|"Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
2724066|NCT01068860|Secondary|Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol*hr/L||Standard Error|Least Squares Mean
2724067|NCT01068860|Secondary|Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||nmol*hour/L||Standard Error|Least Squares Mean
2724068|NCT01068860|Secondary|Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol*hour/L||Standard Error|Least Squares Mean
2724069|NCT01068860|Secondary|Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks|"Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
2724070|NCT01068860|Secondary|Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks|GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||number||Standard Error|Least Squares Mean
2724071|NCT01068860|Secondary|Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks|"The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||number||Standard Error|Least Squares Mean
2724072|NCT01068860|Secondary|Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks|"Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/L||Standard Error|Least Squares Mean
2724073|NCT01068860|Secondary|Mean Change in Fructosamine, From Baseline to 4 Weeks|"Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
2724074|NCT01068860|Secondary|Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks|"Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
2724075|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
2724076|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
2724077|NCT01068860|Primary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
2724078|NCT01068821|Secondary|Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery|The neurologic deficit was assessed as follows: Patients' postoperative care was unchanged from routine for this study. Any postoperative complaints regarding limb pain or weakness or numbness were recorded and assessed with neurologic exam to determine sensation or motor components. Absence of resolution was documented.|postoperative day 1 and postoperative week 3-8|Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)|||participants|||Number
2724079|NCT01068821|Primary|Amount of Patient Movement on the Operating Room Table|Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.|About 150 minutes after start of surgery|Study size calculation was performed for 80% power, and p=0.05|||centimeters||Standard Deviation|Mean
2724080|NCT01068769|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).|From date of enrollment until date of first documented progression or date of death from any cause, whichever came first||||months||95% Confidence Interval|Median
2724081|NCT01068769|Primary|Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control|The composite of complete response, partial response, and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control. This is for target lesions. Complete response is disappearance of all target lesions and partial response is >+30% decrease in the sum of the longest diameter of target lesions. Stable disease is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions. Progressive disease is considered an increase of the sum of the longest diameter of target lesions by greater than or equal to 20%.|2 years||||percentage of participants||95% Confidence Interval|Number
2724082|NCT01068743|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities that were considered clinically significant and/or reported as an AE by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.|||participants|||Number
2724083|NCT01068743|Other Pre-specified|Metformin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||hr||Standard Deviation|Mean
2724084|NCT01068743|Other Pre-specified|Metformin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||hr||Standard Deviation|Mean
2724085|NCT01068743|Other Pre-specified|Metformin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724086|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||hr||Standard Deviation|Mean
2724087|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||hr||Standard Deviation|Mean
2725943|NCT01053663|Secondary|Number of Participants With Oseltamivir Resistance Mutation|Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).|Up to Day 30|Safety population.|||participants|||Number
2724088|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724089|NCT01068743|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs).|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.|||participants|||Number
2724090|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||hr||Standard Deviation|Mean
2724091|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||hr||Standard Deviation|Mean
2724092|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724093|NCT01068743|Primary|Metformin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2724094|NCT01068743|Primary|Metformin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724095|NCT01068743|Primary|Saxagliptin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2724096|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2724097|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724098|NCT01068743|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724099|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724100|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724101|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724102|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724103|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, T 1/2 was not analysed for 1 participant who did not have a clear terminal elimination phase.|||hr||Standard Deviation|Mean
2724104|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.|||hr||Standard Deviation|Mean
2724105|NCT01068730|Secondary|Participants With Abnormal Vital Sign Findings Reported as an AE|per investigator|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724106|NCT01068730|Secondary|Participants With Abnormal Physical Findings|Physical findings that were considered abnormal by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724107|NCT01068730|Secondary|Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724108|NCT01068730|Secondary|Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
2724109|NCT01068730|Primary|Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2724110|NCT01068730|Primary|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, AUC (0-inf) was not analysed for 1 participant who did not have a clear terminal elimination phase.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2724111|NCT01068717|Primary|Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||Hours||Full Range|Median
2724112|NCT01068717|Primary|AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2724113|NCT01068717|Primary|AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2724114|NCT01068717|Primary|AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2724115|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate|Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.|At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.|All enrolled participants who received study medication.|||Participants|||Number
2724116|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|At screening visit, Day -1 of Period 1, and at study discharge|All enrolled participants who received study medication.|||Participants|||Number
2724117|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results|Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.|At screening visit, at Day -1 of Periods 1 through 4, and at discharge|All enrolled participants who received study medication.|||Participants|||Number
2724118|NCT01068717|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4|All enrolled participants who received study medication.|||Participants|||Number
2724119|NCT01068717|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2724120|NCT01068717|Primary|Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||Hours||Standard Deviation|Mean
2724121|NCT01068717|Primary|Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2724122|NCT01068717|Primary|Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2724123|NCT01068678|Secondary|Change in Body Weight|Change from baseline in body weight after week 26|Week 26|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.|||kg||Standard Deviation|Mean
2724124|NCT01068678|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after week 26|Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2724125|NCT01068665|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
2724126|NCT01068665|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2724127|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment|Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
2724128|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment|Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
2726282|NCT01050673|Primary|Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.||28 days plus 6 week follow-up||||Time (minutes)||Standard Deviation|Median
2724130|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment|Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
2724131|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment|Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
2724132|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment|Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
2724133|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment|Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
2724134|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment|Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 28 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
2724135|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)|Week 50|Full Analysis Set (FAS) includes all randomised subjects. For 35 subjects, values were missing.|||Subjects|||Number
2724136|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)|Week 38|Full Analysis Set (FAS) includes all randomised subjects. For 31 subjects, values were missing.|||Subjects|||Number
2724137|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)|Week 26|Full Analysis Set (FAS) includes all randomised subjects. For 29 subjects, values were missing.|||Subjects|||Number
2724138|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)|Week 14|Full Analysis Set (FAS) includes all randomised subjects. For 20 subjects, values were missing.|||Subjects|||Number
2724139|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Week 50|Observed mean change from baseline in HbA1c at Week 50 (visit 32)|Week 0, Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2724140|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 38 (visit 25)|Week 0, Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2724141|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Observed mean change in from baseline in HbA1c at Week 26 (visit 18)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2724142|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 14 (visit 11)|Week 0, Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2724143|NCT01068652|Primary|Glycosylated Haemoglobin (HbA1c)|Estimated mean difference in HbA1c after 50 weeks of treatment|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2724144|NCT01068626|Secondary|Change in LDL||6 months||||mmol/L||Standard Deviation|Mean
2724145|NCT01068626|Secondary|Change in Body Weight||6 months||||kg||Standard Deviation|Mean
2724146|NCT01068626|Secondary|Change in Hepatic Fat Infiltration Measured by CT.||6 months||||Hounsfield units||Standard Deviation|Mean
2724147|NCT01068626|Secondary|Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.||6 months||||ratio||Standard Deviation|Mean
2724148|NCT01068626|Secondary|Change in Subcutaneous Adipose Tissue Area||6 months||||cm2||Standard Deviation|Mean
2724149|NCT01068626|Primary|Change in Visceral Adipose Tissue Area Measured by Computed Tomography.||6 months|Per protocol|||cm2||Standard Deviation|Mean
2724150|NCT01068600|Secondary|Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study medication. If data were missing or insufficient for any one of the domains a focal score was not calculated. Missing focal scores after week 4 were imputed using last observation carried forward.|||Score on a scale||Standard Error|Least Squares Mean
2724151|NCT01068600|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data was imputed using last observation carried forward.|||Liters||Standard Error|Least Squares Mean
2724152|NCT01068548|Secondary|Time to Change to Oral Antibiotics||1 month|PI has left the VA and is not able to determine if data were collected.||||||
2724153|NCT01068548|Primary|Length of Hospital Stay||1 month||||Days||Standard Deviation|Mean
2724154|NCT01068509|Secondary|Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104|Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Arbitrary units||Standard Deviation|Mean
2724155|NCT01068509|Secondary|Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104|Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Arbitrary units||Standard Deviation|Mean
2724156|NCT01068509|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 4 years 10 months)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Months||95% Confidence Interval|Median
2724157|NCT01068509|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.|Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Months||95% Confidence Interval|Median
2724158|NCT01068418|Secondary|The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II||baseline and 1 month following vitamin D3 therapy||||mL/min/1.72m2||Standard Deviation|Mean
2724159|NCT01068418|Primary|The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II||baseline and 1 month following vitamin D3 therapy||||mmHg||Standard Deviation|Mean
2724160|NCT01068262|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of participants who discontinued treatment with Odanacatib 50 mg Qw for 4 consecutive weeks due to AEs was sufficiently low to permit continued clinical investigation.|Up to Week 4|All randomized participants who received ≥1 dose of study treatment|||Participants|||Number
2724161|NCT01068262|Secondary|Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of AEs experienced by participants receiving Odanacatib 50 mg Qw for 4 consecutive weeks was sufficiently low to permit continued clinical investigation. In addition to AEs during the treatment period and post-treatment follow-up period, AEs may have occurred prior to treatment in screened participants as a result of urine and blood sampling at Baseline.|Up to Day 58|All randomized participants who received ≥1 dose of study treatment|||Participants|||Number
2724206|NCT01067716|Other Pre-specified|Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)|After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).|1 Year||||percentage of eyes|Participants|95% Confidence Interval|Number
2724162|NCT01068262|Secondary|Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of the apparent t1/2 of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Harmonic mean, jack-knife standard deviation reported for apparent terminal t1/2.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||hr||Standard Deviation|Mean
2724163|NCT01068262|Secondary|Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Tmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||hr||Full Range|Median
2724164|NCT01068262|Secondary|Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained at 168 hours postdose on Day 22 (Week 4) to determine the similarity of steady-state C168hr (trough concentrations) of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Week 4 (168 hours postdose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||nM||95% Confidence Interval|Geometric Mean
2724165|NCT01068262|Secondary|Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Cmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||nM||95% Confidence Interval|Geometric Mean
2724166|NCT01068262|Secondary|Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state AUC0-168 hr of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Characterization of AUC0-168hr after administration of the final, Qw dose of Odanacatib 50 mg at steady state is reflective of the clinical dosing interval.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||µM·hr||95% Confidence Interval|Geometric Mean
2724167|NCT01068262|Primary|Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females|uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp [mean])*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model.|Baseline to Week 4|The population of male and postmenopausal female participants on Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. The population of male participants on placebo are also included. Postmenopausal females on placebo were not analyzed for WAI due to there being too few participants in this group (N=2).|||Percent inhibition||90% Confidence Interval|Least Squares Mean
2724168|NCT01068158|Secondary|Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 2 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.|||Participants|||Number
2724169|NCT01068158|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Adverse events were defined and classified as follows:~'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 2 up to Day 15 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Participants|||Number
2724170|NCT01068158|Primary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat 2 (All Participants) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
2724229|NCT01067352|Secondary|Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth|Spontaneous catch up growth was the growth shown by SGA participants having length more than third percentile at Week 96 without any study drug treatment.|Baseline through Week 96|Data was not analyzed due to small number of evaluable participants.||||||
2724171|NCT01068158|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in a subset of the Intent-to-treat population (Index participants). Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
2724172|NCT01067976|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow-up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow-up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||participants|||Number
2724173|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow-up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow-up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||beats/min||Standard Deviation|Mean
2724174|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow-up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, Follow-up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||mmHg||Standard Deviation|Mean
2724175|NCT01067976|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
2724176|NCT01067976|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||Kappa|Participants||Number
2724177|NCT01067976|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
2724178|NCT01067976|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Categorical Accuracy Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||kappa|Participants||Number
2724179|NCT01067976|Other Pre-specified|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Majority Reader, Participant Level|The 3 blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1=not confident, 2=somewhat confident, 3=confident, and 4=very confident). The majority read value for the 3 readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers, i.e. multifocal. For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. value respectively. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments by the majority reader for both modalities in the comparison for this assessment. Majority reader results are based on the average of the 3 blinded readers’s assessment.|||difference of scores on a scale|Participants|90% Confidence Interval|Mean
2724191|NCT01067976|Secondary|Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 87 participants in FAS who had at least one additional cancer region according to SoT.|||difference in percentage of participants||95% Confidence Interval|Number
2724291|NCT01066897|Primary|Change in Mesolimbic Reward System Activity From Pre to Post Treatment (8 Weeks)|Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.|baseline and Week 8|Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.||||||
2724180|NCT01067976|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Majority Reader, Participant Level|"The disease state bilateral malignant disease was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region, the assessment of bilateral malignant disease was categorized as No. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as Yes. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease was derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively."|Immediately before injection and after injection|The analyses were based on 388 participants; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.|||difference in accuracy (%)||95% Confidence Interval|Mean
2724181|NCT01067976|Other Pre-specified|Sensitivity Difference of Detection of Multicentric Malignant Disease Verified by SoT by Majority Reader, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on a total number of 53 evaluable breasts with multicentric malignant disease.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2724182|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Single examination|For multifocal malignant disease, specificity analyses were based on a total number of 3816 regions, 390 participants in FAS.|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
2724183|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, specificity analyses were based on a total number of 3307 regions (i.e. regions with no disease or multifocal malignant disease), 390 participants in FAS.|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
2724184|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3240 regions, 390 participants in FAS.|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
2724192|NCT01067976|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 382 participants in FAS. Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.|||difference in percentage of participants||95% Confidence Interval|Number
2724695|NCT01063972|Primary|Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated|Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers.|12 months|Participants who were deceased or incarcerated at month 12 were excluded from analysis.|||Participants|||Count of Participants
2724185|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For multifocal malignant disease, sensitivity analyses were performed for a total number of 67 regions.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2724186|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, sensitivity analyses were performed for a total number of 576 regions (i.e. regions with unifocal disease verified by SoT), 390 participants in FAS.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2724187|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 643 regions, 390 participants in FAS. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
2724188|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 1120 regions, 390 participants from FAS.|||percent difference|Participants|95% Confidence Interval|Mean
2724189|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3883 regions, 390 participants in FAS.|||percent difference|Participants|95% Confidence Interval|Mean
2724190|NCT01067976|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N-FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with or without malignant disease verified by SoT for which assessment by the imaging modality were available.|||specificity (%)||95% Confidence Interval|Mean
2724828|NCT01062568|Secondary|Androstenedione Response to ACTH|Androstenedione levels before and after ACTH|0 and 60 min after ACTH administration|Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls|||ng/mL||Standard Error|Mean
2724193|NCT01067976|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as false positive (FP), when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as true negative (TN). Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
2724194|NCT01067976|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 372 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SOT).|||specificity (%)||95% Confidence Interval|Mean
2724195|NCT01067976|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).|||sensitivity %||95% Confidence Interval|Mean
2724196|NCT01067976|Primary|Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).|||difference in sensitivity (%)||95% Confidence Interval|Mean
2724197|NCT01067846|Primary|Treatment Retention - Number of Visits During Treatment|Number of treatment visits attended prior to discontinuation of treatment|Treatment sessions included 3 visits per week for 4 weeks|Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible.|||visits|Participants|Standard Deviation|Mean
2724198|NCT01067846|Primary|Drug Abstinence During Treatment and at Follow up Visits|Percentage of the overall number of drug abstinences of participants measured by urine drug testing|Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit|Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible.|||percentage of drug abstinences|Participants||Number
2724199|NCT01067781|Secondary|Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates|LT immunoglobulin G (IgG) and immunoglobulin A (IgA)|Day 0 to Day 180|the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35|||percentage of participants||95% Confidence Interval|Geometric Mean
2724200|NCT01067781|Secondary|Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios|LT immunoglobulin G (IgG) and immunoglobulin A (IgA)|Day 0 to Day 180|the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35|||Geometric Mean Fold Ratios (GMFRs)||95% Confidence Interval|Geometric Mean
2724201|NCT01067781|Secondary|Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers|LT immunoglobulin G (IgG) and immunoglobulin A (IgA)|Day 0 to Day 180|the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35|||titers||95% Confidence Interval|Geometric Mean
2724202|NCT01067781|Primary|Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs|Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.|Day 0 to Day 180||||participants|||Number
2724203|NCT01067768|Secondary|Catheter Days|The duration of catheterization|withdrawal of the catheter|Analysis by intention to treat|||Days||Inter-Quartile Range|Median
2724204|NCT01067768|Primary|Rate of Catheter-associated Urinary Tract Infection||Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)|Analysis by intention to treat|||infections per 1000 days||95% Confidence Interval|Number
2724205|NCT01067716|Other Pre-specified|Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power||1 Year||||percentage of eyes|Participants|95% Confidence Interval|Number
2726283|NCT01050660|Secondary|Anthropometric Measurements(Head Circumference)|Change in head circumference measurement reported in cm/week|At age of 28 days and at discharge||||cm/week||Standard Deviation|Mean
2724207|NCT01067716|Other Pre-specified|Percent Manifest Refraction Spherical Equivalent Within 1.0D|Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.|1 Year|As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.|||percentage of eyes|Participants|95% Confidence Interval|Number
2724208|NCT01067716|Primary|Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||1 Year|As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.|||percentage of eyes|Participants|95% Confidence Interval|Number
2724209|NCT01067521|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Early Start: Day 1 up to 6.5 years Delayed Start - Placebo: Day 1 up to Month 12 Delayed Start - GA: Month 13 up to 6.5 years|Glatiramer Acetate (GA) - Treated Analysis Set The GA-Treated analysis set includes all subjects randomized into the study and treated with at least 1 dose of GA at any time during the study. Analyses includes data collected for these subjects from the first time GA was administered.|||Participants|||Count of Participants
2724210|NCT01067521|Secondary|Brain Atrophy As Defined by the Percent of Change in Brain Volume From Baseline to Months 6, 12 and 36 Estimated by a Mixed Model for Repeated Measures|"The analysis of brain atrophy as defined by the percentage change in brain volume from baseline to Months 6, 12 and 36 was performed using mixed model for repeated measures (MMRM) with SIENAX normalized brain volume at baseline, number of Gd-enhancing lesions at baseline, and country or geographical region as fixed effects.~Sienax estimates total brain tissue volume, from a single image, normalised for skull size."|Baseline (Day -7), Month 6, Month 12, Month 36|ITT population of participants with SIENEX brain scans at both baseline and the designated timeframes.|||percentage change||Standard Error|Mean
2724211|NCT01067521|Secondary|The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Months 6, 12 and 36 Estimated by Negative Binomial Regression|All data accumulated from screening, the PC Treatment period up to the end of the Open Label (OL) period are combined and referred to as the Long Term Period. The cumulative number of gadolinium (Gd)-enhanced lesions on T1-weighted images at Months 6, 12 and 36 as compared to the baseline MRI are offered. Adjusted mean is based on negative binomial regression The model was fit using an autoregressive covariance structure. Covariates used: number of enhancing lesions on T1-weighted images at placebo-controlled baseline and country or geographical region. The cumulative number is derived from all the data points before it. For example, if the participant skipped one time point in between the baseline and 36 months, then it cannot be calculated.|Baseline (Day -7), Month 6, Month 12, Month 36|ITT population of participants with MRIs at both baseline and the designated timeframes, inclusive of the proceeding post-baseline timeframes.|||lesions||Standard Error|Mean
2724212|NCT01067521|Secondary|The Number of New/Enlarging T2 Lesions at Months 6, 12 and 36 Estimated by Negative Binomial Regression|"All data accumulated from screening, the PC Treatment period up to the end of the Open Label (OL) period are combined and referred to as the Long Term Period. T2 lesions are hyperintense brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. The number of T2 lesions at Months 6, 12 and 36 that are new or enlarged as compared to the baseline MRI are offered. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions and country or geographical region as covariates. An offset employing the log of the proportion of the number of the available post-placebo-controlled baseline (PCBL) scans was used to adjust for missing MRI scans."|Baseline (Day -7), Month 6, Month 12, Month 36|ITT population of participants with MRIs at both baseline and the designated timeframes.|||lesions||Standard Error|Mean
2724213|NCT01067521|Primary|Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression|"The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an offset based on the log of exposure to treatment."|Day 1 up to 6.5 years|ITT|||relapses per year||Standard Error|Mean
2724214|NCT01067521|Secondary|Brain Atrophy As Defined by the Percent of Change in Normalized Brain Volume From Baseline to Month 12 During the Placebo Controlled (PC) Treatment Period|"The analysis of brain atrophy as defined by the percentage change in normalized brain volume from baseline to Month 12 was based on the outcome of a contrast (GA 40 mg TIW vs. placebo) derived from a baseline-adjusted ANCOVA. In addition to the treatment group, the model included the following covariates: - SIENAX normalized brain volume at baseline. - The number of enhancing lesions on T1-weighted images at baseline. - country or geographical region.~Sienax estimates total brain tissue volume, from a single image, normalised for skull size."|Baseline (Day -7), Month 12|ITT population of participants who had SIENEX brain volume estimates at both baseline and Month 12.|||percentage change||Standard Error|Mean
2724284|NCT01066936|Primary|DEXA Analysis of BMD at 3 Months|DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.|3 Months||||g/cm^2||Standard Deviation|Mean
2724215|NCT01067521|Secondary|The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Month 6 and Month 12 of the Placebo-Controlled (PC) Treatment Period Estimated by Negative Binomial Regression|"The cumulative number of gadolinium (Gd)-enhanced lesions on T1-weighted images at Months 6 and 12 as compared to the baseline MRI are offered. Note that the two timeframes (Months 6 and 12) are combined. Adjusted mean is based on negative binomial regression with an offset employing the log of the proportion of the number of the available post-baseline scans to adjust for missing MRI scans (if any), adjusted for baseline number of enhancing lesions on T1-weighted images and country or geographical region as covariates."|Baseline (Day -7), Month 6, Month 12|ITT. When a subject had both Month 6 and Month 12 scans missing, the subject was excluded from the analysis.|||lesions||Standard Error|Mean
2724216|NCT01067521|Secondary|The Cumulative Number of New/Enlarging T2 Lesions Taken at Month 6 and Month 12 During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression|T2 lesions are hyperintense brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. The cumulative number of T2 lesions at Months 6 and 12 that are new or enlarged as compared to the baseline MRI are offered. Note that the two timeframes (Months 6 and 12) are combined. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions and country or geographical region as covariates.|Baseline (Day -7), Month 6, Month 12|ITT. When a subject had both Month 6 and Month 12 scans missing, the subject was excluded from the analysis. When the Month 12 scan was missing, data from Month 6 was used and an offset of log (0.5) introduced. When the Month 6 scan was missing, data from Month 12 was used with an offset of 0.|||lesions||Standard Error|Mean
2724217|NCT01067521|Primary|Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression|Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting >= 48 hours and immediately preceded by an improving neurological state of at >=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with >= one of the following: - An increase of >= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of >=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed.|Day 1 to 12 months|Intent To Treat (ITT) Analysis Population|||confirmed relapses||Standard Error|Mean
2724218|NCT01067508|Primary|Change From Baseline in Silicon Absorption at 12 Weeks|Change from baseline in silicon absorption in response to silicon-rich water (Fiji) supplementation for 12 weeks was determined by measuring urinary solicon concentration (mg/mg) normalized to creatinine.|12 Weeks||||mg/mg creatinine||Standard Deviation|Mean
2724219|NCT01067469|Secondary|Summary of Treatment Related Toxicities|Adverse Events grade 3 and 4 hematologic toxicities reported in safety profile of bevacizumab (Avastin) in combination with Lomustine in patients with recurrent glioblastoma using Common Terminology Criteria for Adverse Events (CTCAE) version 3.|One year||||Participants|||Count of Participants
2724220|NCT01067469|Secondary|Time to Progression (TTP)|TTP is defined as the time from randomization to time of progressive disease|Up to One year|Data were not collected for the outcome for Time to Progression (TTP)||||||
2724221|NCT01067469|Secondary|Overall Survival (OS)|Overall Survival(OS) is defined: Time of presentation to date of death or censored at last follow-up date|through study completion, an average of 2 years||||Months||95% Confidence Interval|Median
2724222|NCT01067469|Secondary|6-month Progression-free Survival (PFS-6)|Participants with no disease progression as measured by magnetic resonance imaging (MRI) scans. Participants followed by MRI scans, as used for baseline tumor measurements, and removed from study if progression is documented after any cycle of treatment. PFS determined from date of registration in the trial and not date of randomization into chemotherapy arms (i.e. after surgery for resection of recurrent tumor).|6 Months||||percentage of participants||95% Confidence Interval|Number
2724223|NCT01067469|Secondary|Radiographic Response (RR)|Definition of Modified Radiographic Response Assessment Criteria for Glioblastoma (GBM) . Complete, Partial, Progressive Disease and Stable Disease. Radiographic response determined in comparison to the tumor measurements obtained at baseline (post-radiation scan will be baseline for newly diagnosed GBM and pre-treatment scans will be the baseline for recurrent GBM) for determination of response, and the smallest tumor measurement at either pre-treatment baseline or following initiation of therapy for determining progression.|One year||||Participants|||Count of Participants
2724224|NCT01067469|Primary|Progression Free Survival (PFS)|Participants with no disease progression as measured by magnetic resonance imaging (MRI) scans. Participants followed by MRI scans, as used for baseline tumor measurements, and removed from study if progression is documented after any cycle of treatment. PFS determined from date of registration in the trial and not date of randomization into chemotherapy arms (i.e. after surgery for resection of recurrent tumor).|Documented from the date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year||||months||95% Confidence Interval|Median
2724225|NCT01067456|Secondary|Cost of Care|Cost of stay in USD|Index Hospitalization (within 48 hours)||||cost in USD||Inter-Quartile Range|Median
2724226|NCT01067456|Secondary|Direct Hospital Discharge Without Imaging|Number of patients discharged without imaging|Index Hospitalization (within 48 hours)||||Participants|||Count of Participants
2724227|NCT01067456|Primary|Length of Hospital Stay||Index Hospitalization (within 48 hours)||||Hours||Inter-Quartile Range|Median
2724228|NCT01067352|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug , SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|Baseline through Week 96|Safety analysis population included all randomized participants with at least 1 post-baseline assessment.|||participants|||Number
2724230|NCT01067352|Primary|Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children|Gene expression profiling:analysis of ribonucleic acid (RNA) extracted from body tissue or fluids using Clontech Atlas Human Array to study level of activation of genes in tissue analyzed. Analysis was performed to identify possible correlation between catch-up growth (either spontaneous or drug-induced after Week 48) and therapeutic response to rhGH. Spontaneous catch up growth:shown by SGA participants having length more than third percentile at Week 96 without any treatment;drug induced growth was by SGA participants having length more than third percentile at Week 96 with drug treatment.|Baseline and Week 48|Gene expression profiling was not performed due to RNA degradation in nearly all of the blood samples and hence no comparison between gene expression and growth was made.||||||
2724231|NCT01067339|Primary|Percentage Change in Coronary Blood Flow (CBF)|The change in coronary blood flow was measured in response to maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary blood flow provides a measure of endothelium dependent microvascular function.|baseline, six months||||% change coronary blood flow||Inter-Quartile Range|Mean
2724232|NCT01067339|Primary|Percentage Change in Coronary Artery Diameter|The change of coronary artery diameter was measured in response to a maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary artery diameter provides a measure of endothelium dependent epicardial function.|baseline, six months||||% change coronary artery diameter||Inter-Quartile Range|Mean
2724233|NCT01067326|Primary|Reactive Hyperemia Index (RHI)|"RHI was measured by the noninvasive endothelial peripheral arterial tomography (EndoPat) test. EndoPAT results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|Baseline, 4 Months||||units on a scale||Inter-Quartile Range|Median
2724234|NCT01067326|Secondary|Diastolic Blood Pressure||Baseline, 4 Months||||mm Hg||Standard Deviation|Mean
2724235|NCT01067326|Secondary|Systolic Blood Pressure||Baseline, 4 Months||||mm Hg||Standard Deviation|Mean
2724236|NCT01067326|Primary|Endothelial Progenitor Cells (EPC)|Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.|Baseline, 4 Months||||counts per 100,000 gated events||Inter-Quartile Range|Median
2724237|NCT01067144|Secondary|Count of Participants With Continued Opioid Use at 1 Year|Continued opioid use was defined as any report of any continued opioid use at Year 1.|Year 1|Intention-to-Treat Analysis Set|||Participants|||Count of Participants
2724238|NCT01067144|Secondary|Count of Participants With Continued Opioid Use at 6 Months|Continued opioid use was defined as any report of any continued opioid use at Month 6.|Month 6|Intention-to-Treat Analysis Set|||Participants|||Count of Participants
2724239|NCT01067144|Secondary|Count of Participants With Continued Pain at 1 Year|"Continued pain was defined as a report of at least 1 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain)."|Year 1|Intention-to-Treat Analysis Set|||Participants|||Count of Participants
2724240|NCT01067144|Secondary|Count of Participants With Continued Pain at 6 Months|"Continued pain was defined as a report of at least 1 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain)."|Month 6|Intention-to-Treat Analysis Set|||Participants|||Count of Participants
2724241|NCT01067144|Secondary|Time to Opioid Cessation|Time to opioid cessation was defined as 5 consecutive reports of no opioid use. Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.|Up to 2 years|Intention-to-Treat Analysis Set|||days||Inter-Quartile Range|Median
2724242|NCT01067144|Primary|Time to Pain Resolution|"Time to pain resolution was defined as 5 consecutive reports of 0 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery."|Up to 2 years|Intention-to-Treat Analysis Set|||days||Inter-Quartile Range|Median
2724243|NCT01067105|Secondary|Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey|Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.|Weeks 6 and 12|Intent to Treat Population|||participants|||Number
2724244|NCT01067105|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population|||percentage of devices|||Number
2724245|NCT01067105|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population|||devices|||Number
2724246|NCT01067105|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population|||percentage of devices|||Number
2724247|NCT01067105|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population.|||devices|||Number
2724248|NCT01067105|Secondary|Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances|Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.|Weeks 0-12|Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.|||percentage of correct advances||Standard Deviation|Mean
2724829|NCT01062568|Secondary|Free Testosterone Response to ACTH|Free Testosteorne levels before and after ACTH|0 and 60 min after ACTH administration|Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls|||pmol/L||Standard Error|Mean
2724249|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2724250|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, and 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2724251|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2724252|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2724253|NCT01067105|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
2724254|NCT01067105|Primary|Percentage of Subjects Who Discontinue Due to AEs.||Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
2724255|NCT01067105|Primary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs)||Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
2724256|NCT01067105|Primary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
2724257|NCT01066936|Secondary|Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|5 Years|All available subjects participating in this time point visit assessment.|||Participants|||Count of Participants
2724258|NCT01066936|Secondary|Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|1 Year||||Participants|||Count of Participants
2724259|NCT01066936|Secondary|Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|3 Months||||Participants|||Count of Participants
2724260|NCT01066936|Secondary|Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|Discharge||||Participants|||Count of Participants
2724261|NCT01066936|Secondary|Radiographic Assessment at 5 Year Visit|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|5 Year|All available subjects participating in this time point visit assessment.|||degree||Standard Deviation|Mean
2724262|NCT01066936|Secondary|Radiographic Assessment at 1 Year Visit|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|1 Year||||degree||Standard Deviation|Mean
2724263|NCT01066936|Secondary|Radiographic Assessment at 3 Month Visit|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|3 Months||||degree||Standard Deviation|Mean
2724264|NCT01066936|Secondary|Radiographic Assessment at Discharge Visit|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|Discharge||||degree||Standard Deviation|Mean
2724265|NCT01066936|Secondary|Radiographic Assessment at 5 Year Visit (Yes/No Components)|"Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.~The Brooker Classification was defined as:~Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip"|5 Year|All participants available at this time point visit assessment.|||Participants|||Count of Participants
2726284|NCT01050660|Secondary|Anthropometric Measurements(Length)|Change in body length measurement reported in cm/week|At age of 28 days and at discharge||||cm/week||Standard Deviation|Mean
2724266|NCT01066936|Secondary|Radiographic Assessment at 1 Year Visit (Yes/No Components)|"Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.~The Brooker Classification was defined as:~Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip"|1 Year||||Participants|||Count of Participants
2724267|NCT01066936|Secondary|Radiographic Assessment at 3 Month Visit (Yes/No Components)|"Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.~The Brooker Classification was defined as:~Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip"|3 Months||||Participants|||Count of Participants
2724268|NCT01066936|Secondary|Radiographic Assessment at Preoperative Visit (Yes/No Components)|"Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.~The Brooker Classification was defined as:~Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip"|Discharge||||Participants|||Count of Participants
2724269|NCT01066936|Secondary|Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit|"The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).~Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.~Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms."|5 Years|Information was not provided from the study site for 1 subject in the HOOS Pain (0-100), Daily Living (0-100), Sports/Recreational Activities (0-100), and Quality of Life (0-100) categories.|||score on a scale||Standard Deviation|Mean
2724270|NCT01066936|Secondary|Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit|"The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).~Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.~Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms."|2 Years|Number of participants returning for this time point visit assessment. Information was not provided from the study site for 1 subject in the HOOS Sports/Recreational Activities (0-100) and Quality of Life (0-100) categories.|||score on a scale||Standard Deviation|Mean
2724271|NCT01066936|Secondary|Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit|"The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).~Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.~Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms."|1 Year|Number of participants returning for this time point visit assessment.|||score on a scale||Standard Deviation|Mean
2724272|NCT01066936|Secondary|Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit|"The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).~Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.~Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms."|6 Months|Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.|||score on a scale||Standard Deviation|Mean
2724285|NCT01066936|Primary|DEXA Analysis of BMD at Preoperative Visit|DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.|Preoperative||||g/cm^2||Standard Deviation|Mean
2724273|NCT01066936|Secondary|Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit|"The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).~Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.~Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms."|3 Months|Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.|||score on a scale||Standard Deviation|Mean
2724274|NCT01066936|Secondary|Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit|"The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).~Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.~Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms."|Preoperative||||score on a scale||Standard Deviation|Mean
2724275|NCT01066936|Secondary|Harris Hip Score (HHS) at 5 Year Visit|"The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:~Total Scale Ranges:~Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60~Subscore Ranges:~Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5~The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems."|5 Year|Number of participants returning for this time point visit assessment.|||score on a scale||Standard Deviation|Mean
2724276|NCT01066936|Secondary|Harris Hip Score (HHS) at 2 Year Visit|"The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:~Total Scale Ranges:~Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60~Subscore Ranges:~Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5~The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems."|2 Years|Number of participants returning for this time point visit assessment.|||score on a scale||Standard Deviation|Mean
2724277|NCT01066936|Secondary|Harris Hip Score (HHS) at 1 Year Visit|"The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:~Total Scale Ranges:~Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60~Subscore Ranges:~Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5~The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems."|1 Year|Two subjects were missing results from the study site for the HHS.|||score on a scale||Standard Deviation|Mean
2724278|NCT01066936|Secondary|Harris Hip Score (HHS) at 6 Month Visit|"The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:~Total Scale Ranges:~Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60~Subscore Ranges:~Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5~The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems."|6 Months||||score on a scale||Standard Deviation|Mean
2724279|NCT01066936|Secondary|Harris Hip Score (HHS) at 3 Month Visit|"The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:~Total Scale Ranges:~Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60~Subscore Ranges:~Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5~The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems."|3 Month|Overall number of participants analyzed was 20 particpants; however, for the Function and Total Overall portion of the questionnaire only 18 participants responded.|||score on a scale||Standard Deviation|Mean
2724280|NCT01066936|Secondary|Baseline Harris Hip Score (HHS) at Preoperative Visit|"The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:~Total Scale Ranges:~Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60~Subscore Ranges:~Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5~The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems."|Preoperative||||score on a scale||Standard Deviation|Mean
2724281|NCT01066936|Primary|DEXA Analysis of BMD at 2 Years|DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.|2 Year||||g/cm^2||Standard Deviation|Mean
2724282|NCT01066936|Primary|DEXA Analysis of BMD at 1 Year|DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.|1 Year||||g/cm^2||Standard Deviation|Mean
2724283|NCT01066936|Primary|DEXA Analysis of BMD at 6 Months|DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.|6 Months||||g/cm^2||Standard Deviation|Mean
2724292|NCT01066897|Primary|% Change in Hamilton Depression Rating Scale From Baseline to week8|"Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores equals more depression. For the change score, where higher equals greater improvement in depressive symptoms.~Healthy controls were not utilized in this analysis, as no week 8 ratings for health controls were obtained."|Baseline and weeks 8|For two drop outs, used LOCF|||percentage reduction in depression score||Standard Deviation|Mean
2724293|NCT01066897|Primary|Number of Participants Who Discontinued Study Due to Side-effects of the Medication||throughout the 8 weeks|# of participants who dropped out due to medication side-effects|||Participants|||Count of Participants
2724294|NCT01066871|Secondary|Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18)|Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported.|Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.|||participants|||Number
2724295|NCT01066871|Secondary|Number of Participants With Acute Inflammatory Reactions|Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection.|Baseline up to Month 12|"Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."|||participants|||Number
2724296|NCT01066871|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body.|Baseline up to Month 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.|||participants|||Number
2724297|NCT01066871|Secondary|Number of Participants With Global Evaluation of Treatment Benefit|Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent.|Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||participants|||Number
2724298|NCT01066871|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12|The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||units on a scale||Standard Deviation|Mean
2724299|NCT01066871|Secondary|Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12|The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury.|Baseline, Months 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||participants|||Number
2724300|NCT01066871|Secondary|Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 [patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral], synovitis, and effusion) scores at Month 12 were reported.|Month 12|The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment.|||participants|||Number
2724315|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724301|NCT01066871|Secondary|Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes.|Baseline, Month 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||units on a scale||Standard Deviation|Mean
2724302|NCT01066871|Secondary|Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales|MOCART scoring system (comprising 9 variables) was used to describe the morphology & signal intensity of the repair tissue following MRI -degree of defect repair [DDR] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone [IBZ] score 0 (> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue [SRT] score 0 (>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue [StRT] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity [T2] Mapping Sequence [T2MS] and Hi-Res Sagittal Pharmacodynamic Sequence [Hi-Res SPS] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions & effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair.|Months 3 (M3), 6 (M6) and 12 (M12)|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||participants|||Number
2724303|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12|The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively.|Baseline, Months 3, 6 and 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||millimeter||Standard Deviation|Mean
2724304|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12|The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||microliter||Standard Deviation|Mean
2724305|NCT01066871|Secondary|Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6|Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: ([volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively]*100)/volume or thickness at baseline.|Baseline, Months 3 and 6|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||Percent change||Standard Deviation|Mean
2724306|NCT01066871|Primary|Percent Change From Baseline in Cartilage Defect Volume at Month 12|Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)*100/volume at baseline.|Baseline, Month 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."|||Percent change||Standard Deviation|Mean
2724307|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
2724308|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
2724309|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
2724310|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
2724311|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|During first 12 weeks of treatment|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||participants|||Number
2724312|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||participants|||Number
2724313|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724314|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724351|NCT01066780|Secondary|The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.||2-4 weeks|||||||
2724830|NCT01062568|Primary|17-hydroxyprogesterone Response to ACTH|17-hyrooxyprogesterone levels before and after ACTH|0 and 60 minutes after ACTH administration|Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls|||ng/mL||Standard Error|Mean
2724316|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724317|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|Th PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724318|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724319|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724320|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724321|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724322|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724390|NCT01066039|Secondary|Change From Baseline in Insulin Level at Months 3 and 6|The change in insulin level at Months 3 and 6 was calculated as insulin level at Months 3 and 6 minus insulin level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.|||mcIU/mL||Standard Deviation|Mean
2724323|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724324|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724325|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724326|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 international units per millilitre (IU/mL) were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724327|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The per-protocol (PP) population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724328|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks (Wk) after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724329|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
2726285|NCT01050660|Secondary|Anthropometric Measurements(Body Weight)|Change in body weight measurement reported in g/week|At age of 28 days and at discharge||||g/week||Standard Deviation|Mean
2724330|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
2724331|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
2724332|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
2724333|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||number of participants|||Number
2724334|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||number of participants|||Number
2724335|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724423|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body|Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body|Baseline to 14 days|per protocol|||Percentage of participants||Standard Deviation|Mean
2724336|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724337|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724338|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724339|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724340|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724341|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724342|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724343|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724344|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724345|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724346|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724347|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724348|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724349|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724350|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
2724352|NCT01066780|Primary|Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise|This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.|4 Weeks||||percentage of words scored correctly||Standard Deviation|Mean
2724353|NCT01066624|Primary|Incidence of Oral Mucositis|Incidence of grade I-IV oral mucositis|First 30 days post-tranplantation||||percentage of participants|||Number
2724354|NCT01066585|Secondary|Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
2724355|NCT01066585|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severity of the adverse events were defined and classified as follows:~'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 1 up to Day 15 post-application.|Adverse events were assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
2724356|NCT01066585|Secondary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
2724357|NCT01066585|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
2724358|NCT01066546|Secondary|Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state."|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724359|NCT01066546|Secondary|Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver's job. Overall cost of care was evaluated to quantify the resources utilized.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724360|NCT01066546|Secondary|Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer's Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724361|NCT01066546|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724362|NCT01066546|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724363|NCT01066546|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724364|NCT01066546|Secondary|Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
2724365|NCT01066546|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 4 weeks after last dose of study treatment|Safety analysis population included all enrolled participants who received at least 1 dose of study treatment, including partial doses.|||participants|||Number
2724366|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in percentages."|From baseline (day 1) visit to day 7||||Percentage change in scale VAS||Inter-Quartile Range|Median
2724367|NCT01066520|Secondary|Global Judgment of Efficacy||Day 14|||||||
2724368|NCT01066520|Secondary|Time to Normal Function (Training/Sports)||Day 1 to 4, 7, 14, 42|||||||
2724369|NCT01066520|Secondary|Physician's Assessment of Normal Function/Activity (5-point-scale)||Day 1 to 4, 7, 14, 42|||||||
2724370|NCT01066520|Secondary|Swelling ('Figure-of-eight')||Day 1 to 4,7,14|||||||
2724371|NCT01066520|Secondary|FAAM Sports Subscale||Day 1 to 4, 7, 14, 42|||||||
2724372|NCT01066520|Secondary|FAAM ADL Subscale||Day 1 to 4, 14, 42|||||||
2724373|NCT01066520|Primary|Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7|"The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.~Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted.~Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction."|Day 1 to day 7|Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the ‘Last Observation Carried Forward’ method.|||Scores on a scale||Inter-Quartile Range|Median
2724374|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in absolute values."|From baseline (day 1) visit to day 7|Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method.|||Absolute value units on a scale VAS||Inter-Quartile Range|Median
2724375|NCT01066156|Primary|Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.|"We will compare patients' symptomatology at baseline vs. at 8 week timepoint~Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)~Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136~For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst~If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed"|8 weeks|It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).|||units on a scale||Standard Deviation|Mean
2724376|NCT01066143|Primary|Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.|Changes in anxiety symptomatolgy|12 week|8 subjects signed the consent but were later found to be ineligible; the study didn't start||||||
2724377|NCT01066104|Secondary|Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination.|"Improvement is defined as any reduction in the total nasal polyp score. Using rhinoscopic evaluation, Nasal Polyp Score will be assessed on the right and on the left, and added together.~Scoring system:~Score Definition 0 No polyps~Polyp in middle meatus, not reaching below the inferior border of the middle turbinate~Polyp reaching below the inferior border of the middle turbinate but not touching the inferior turbinate~Polyp reaching below the inferior border of the middle turbinate and touching the inferior turbinate~Polyp reaching to or below the lower border of the inferior turbinate~Range: minimum 0 (better outcome), maximum 8 (worse outcome)"|4 months||||Change in Total polyp score||Standard Deviation|Mean
2726286|NCT01050660|Secondary|Length of Stay|Defines time to discharge or death.|At discharge from Newborn ICU/death||||Days||Inter-Quartile Range|Mean
2724378|NCT01066104|Primary|Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan.|"Improvement is defined as any decrease in sinus CT scores at end of study.~Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan (primary outcome variable):~A sinus CT scan will be performed on Day 0 and repeated on Day 112. The CT scans will be performed with consistent orientation of the patient's head and landmarks to assure that both the pretreatment and posttreatment scans are done with identical orientation and sections. The CT scans will be scored using the established scoring system known as the Zinreich modification of the Lund Mackay scoring system.. As an exploratory measure, a 3-dimensional scoring system developed with the radiology department of Massachusetts General Hospital may also be used."|4 months||||% Change||Standard Deviation|Mean
2724379|NCT01066052|Secondary|Number of Participants Who Reached Normal Height at Year 4|Participants with normal height were those who attained a height which was within +/- 2 height SDS of reference population standard. Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender.|Year 4|All treated participants from r-hGH arm. This outcome measure was only planned in the r-hGH arm.|||participants|||Number
2724380|NCT01066052|Secondary|Number of Participants With Abnormal Insulin-Like Growth Factor 1 (IGF1) Levels|The normal range for IGF1 levels is 45 to 117 nanogram per milliliter (ng/mL) for girls aged less than (<) 3 years and 80 to 236 ng/mL for girls aged 3 to 6 years. Values outside the normal range were considered abnormal. Number of participants, who had abnormal IGF1 levels any time during the assessment, were reported.|Baseline up to Year 2|All treated participants from r-hGH arm. This outcome measure was only planned in the r-hGH arm.|||participants|||Number
2724381|NCT01066052|Secondary|Number of Participants With Anti r-hGH Antibodies||Baseline up to Year 2|Data for this outcome was not collected from any participant.||||||
2724382|NCT01066052|Secondary|Difference Between Bone Age (BA) and Chronological Age (CA) (BA-CA)|BA was determined using left wrist and hand X-ray. CA was determined using the date of birth. Difference of BA and CA (BA-CA) was reported.|Baseline, Year 1, Year 2|All treated participants from r-hGH arm. This outcome measure was only planned in the r-hGH arm. Overall number of participants analyzed = participants with available data for this outcome; number analyzed = participants with available data for this outcome at specified timepoint.|||months||Standard Deviation|Mean
2724383|NCT01066052|Secondary|Number of Participants With Abnormal Glycated Hemoglobin (HbA1c) Levels|HbA1c develops when hemoglobin, a protein within red blood cells that carries oxygen throughout the body, joins with glucose in the blood, becoming glycated. The higher the level of glucose in the blood, the higher the level of HbA1c is detectable on red blood cells. The normal range for HbA1c is 4 percent (%) to 5.9%. Number of participants, who had abnormal HbA1c levels any time during the assessment, were reported.|Baseline up to Year 2||||participants|||Number
2724384|NCT01066052|Primary|Height SDS at Year 4|Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender.|Year 4|All treated participants from r-hGH arm and all participants from Historical Control arm.|||standard deviation score||Standard Deviation|Mean
2724385|NCT01066039|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 6|Safety population included all participants who received at least one dose of investigational product.|||participants|||Number
2724386|NCT01066039|Secondary|Change From Baseline in Microalbumin Level at Month 6|The change in microalbumin level at Month 6 was calculated as microalbumin level at Month 6 minus microalbumin level at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||mg/dL||Standard Deviation|Mean
2724387|NCT01066039|Secondary|Change From Baseline in Albumin/Creatinine Ratio at Month 6|The change in albumin/creatinine ratio at Month 6 was calculated as albumin/creatinine ratio at Month 6 minus albumin/creatinine ratio at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||ratio||Standard Deviation|Mean
2724388|NCT01066039|Secondary|Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6|The change in total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels at Month 6 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at Month 6 minus total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline, respectively.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2724389|NCT01066039|Secondary|Change From Baseline in C-Peptide Level at Months 3 and 6|The change in C-peptide level at Months 3 and 6 was calculated as C-peptide level at Months 3 and 6 minus C-peptide level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2724424|NCT01065714|Primary|Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle|Day 1 to Day 14|Per protocol|||percent change||Full Range|Median
2724391|NCT01066039|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6|HOMA-IR is as an indicator of insulin resistance in participants with Type 2 diabetes mellitus and comorbid hypertension. HOMA-IR was derived from fasting plasma glucose (FPG) and fasting insulin (FI) using the formula: (FI [micro international units per milliliter {mcIU/mL}] * FPG [millimole per liter {mmol/L}]) divided by 22.5. The change in HOMA-IR at Months 3 and 6 was calculated as HOMA-IR at Months 3 and 6 minus HOMA-IR at baseline.|Baseline, Months 3 and 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||mcIU/mL * mmol/L||Standard Deviation|Mean
2724392|NCT01066039|Secondary|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6|The change in SBP, DBP, and mean BP at Month 6 were calculated as SBP, DBP, and mean BP at Month 6 minus SBP, DBP, and mean BP at baseline, respectively. Mean BP was calculated using the formula: (DBP plus [{SBP minus DBP} divided by 3]).|Baseline, Month 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||mmHg||Standard Deviation|Mean
2724393|NCT01066039|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 3 was calculated as HbA1c at Month 3 minus HbA1c at baseline.|Baseline, Month 3|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||Percent HbA1c||Standard Deviation|Mean
2724394|NCT01066039|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline.|Baseline, Month 6|Full analysis set (FAS) included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||Percent HbA1c||Standard Deviation|Mean
2724395|NCT01066000|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.|||Participants|||Number
2724396|NCT01066000|Secondary|Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods|Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.|Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20|ITT population was defined as all participants who entered into study and took at least one dose of study drug. The ITT and safety population were identical. Data of maximum number of participants (24 participants) available at the time of analysis were analysed and 9 participants discontinued the study before this analysis.|||μg/month||Standard Deviation|Mean
2724397|NCT01066000|Secondary|Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods|Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Months||Standard Deviation|Mean
2724398|NCT01066000|Secondary|Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period|Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Weeks||Standard Deviation|Mean
2724399|NCT01066000|Secondary|Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period|The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Percentage of participants|||Number
2724400|NCT01066000|Secondary|Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period|The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||g/dL||Standard Deviation|Mean
2724425|NCT01065714|Primary|Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion|Day 1 to Day 14|per protocol|||percent change||Full Range|Median
2724831|NCT01062425|Secondary|Incidence of Grade 3+ Toxicities|The number of patients with reported grade 3 and higher treatment-related toxicities as assessed by Common Terminology Criteria for Adverse Events version 4.0|From randomization to six months.|All randomized and eligible patients who started protocol treatment.|||participants|||Number
2724401|NCT01066000|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.|||Participants|||Number
2724402|NCT01066000|Primary|Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)|The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.|Up to Week 24|Intent to treat (ITT) population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Percentage of participants|||Number
2724403|NCT01065844|Primary|Tumor Progression|Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).|Every 1 to 3 months|Those with adverse events necessitating interruption of intervention and removal from study were not assessed for outcome measures|||Participants|||Count of Participants
2724404|NCT01065818|Primary|Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response||2.5 months|Due to poor enrollment, data was not analyzed. Adequate data was not collected and the only type of data that remained available was the total # enrolled, some information of the population demographics, and AE/SAE logs that were submitted to the IRB for review.||||||
2724405|NCT01065779|Primary|Change From Baseline in Alkaline Phosphatase at End of Treatment|For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||mg/dL||Standard Deviation|Mean
2724406|NCT01065779|Primary|Change From Baseline in Urine Deoxypyridinoline at End of Treatment|For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||nmol/mmol||Standard Deviation|Mean
2724407|NCT01065779|Primary|Change From Baseline in Serum Osteocalcin at End of Treatment|For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||ng/mL||Standard Deviation|Mean
2724408|NCT01065779|Primary|Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment|For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||ng/mL||Standard Deviation|Mean
2724409|NCT01065779|Primary|Number of Participants With Improved, Unchanged, or Worsened Disease|"Evaluation of disease improvement was conducted in 3 categories of improved, unchanged, or worsened. Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either improved, unchanged, or worsened."|Baseline and end of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation.|||Participants|||Number
2724426|NCT01065597|Secondary|Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level|Change in plasma level of BDNF in pg/ml pre and post NET treatment course.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 subjects had a seizure during the first treatment and therefore had no seizure-free (nonconvulsive) data, and 2 subjects declined blood draw|||pg/ml||Full Range|Median
2724410|NCT01065779|Primary|Number of Participants With Non-Serious AEs|An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.|||Participants|||Number
2724411|NCT01065779|Primary|Number of Participants With Unexpected Adverse Events|Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.|||Participants|||Number
2724412|NCT01065779|Primary|Number of Participants With Serious Adverse Events|"Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.~SAEs were considered serious if the event resulted in:~death or was life-threatening~prolonged an existing inpatient hospitalization~a persistent or significant disability/ incapacity~a congenital anomaly/ birth defect~a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator"|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.|||Participants|||Number
2724413|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24|"Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 24|Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.|||Percentage of participants|||Number
2724414|NCT01065766|Primary|Change From Baseline in 2hr-PPG at Week 24|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG.|||mg/dL||Standard Deviation|Mean
2724415|NCT01065766|Primary|Change From Baseline to Treatment in FPG at Week 24|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of FPG.|||mg/dL||Standard Deviation|Mean
2724416|NCT01065766|Primary|Change From Baseline to Treatment in HbA1c at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.|Baseline and Week 24|All participants with a pre-treatment and a 24-week post-treatment HbA1c value.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
2724417|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12|"Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 12|Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.|||Percentage of participants|||Number
2724418|NCT01065766|Primary|Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.|||mg/dL||Standard Deviation|Mean
2724419|NCT01065766|Primary|Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.|||mg/dL||Standard Deviation|Mean
2724420|NCT01065766|Primary|Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12|HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.|Baseline and Week 12|All participants with a pre-treatment and a 12-week post-treatment HbA1c value.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
2724421|NCT01065766|Primary|Percentage of Participants With Any Adverse Experience|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 26 weeks|All participants who were included in the safety evaluation|||Percentage of participants|||Number
2724422|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.|Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle|Baseline to 14 days|per protocol|||percentage of participants||Standard Deviation|Mean
2724427|NCT01065597|Secondary|Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S)|The Autobiographical Memory Inventory Short Form (AMI-S ) assesses effects on retrograde memory for autobiographical information including information related to a family member, recent travel, events of last New Year's eve, events of last birthday, employment information, and events of last non-psychiatric illness and its treatment. Subjects responded to specific questions regarding these topics before and after their course of NET treatment. Subjects were scored based on the percent of responses post-NET treatment that correctly matched their responses prior to NET treatment. The score range is 0 to 100%. The higher the percent, the less impaired is the autobiographical memory.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data|||% correct responses||Standard Deviation|Mean
2724428|NCT01065597|Secondary|Change in Score on Mini-mental State Exam|Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data|||units on a scale||Standard Deviation|Mean
2724429|NCT01065597|Primary|Change in Score on the 17-item Hamilton Depression Rating Scale|Score range is 0 to 54 points. The higher the score, the more depressed symptoms.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data|||units on a scale||Standard Deviation|Mean
2724430|NCT01065571|Secondary|Serum Interleukin-6 (pg/ml)|Difference in IL-6 between groups between baseline and end of study participation|change in IL-6 between baseline and up to one year of study participation|change in IL-6 between baseline and end of participation|||pg/ml||Standard Deviation|Mean
2724431|NCT01065571|Secondary|Fecal Calprotectin (Microgram/Gram Stool)|paired t-test comparing mean values at baseline and at end of study participation by group|one year or relapse or withdrawal compared with baseline|participants who had fecal calprotectin tests at baseline and at end of participation at one year or at time of relapse or withdrawal from study participation|||micrograms/gm stool||Standard Deviation|Mean
2724432|NCT01065571|Primary|Number of Relapses by Group|log-rank test to test for difference in number of relapses by group|up to one year of participation for each enrolled subject||||relapses|||Number
2724433|NCT01065558|Secondary|Decrease in Self-injurious Behavior at End of Study (Two Weeks After Screening) Compared to Screening|Change in the self-injurious subscale of the Behavior Problems Inventory (BPI). the BPI is a well-validate test to evaluate the frequency and severity of a patient's self-injurious behavior. Values range from 0 to 50, and a low score means few/less severe behaviors|Screening visit and end of study (two weeks)|All patients who received any dose of ecopipam were in the analysis population|||Change in BPI score||Standard Deviation|Mean
2724434|NCT01065558|Primary|Number of Participants With Clinically Significant Changes in Standard Laboratory Tests|This study's primary outcome is the safety of ecopipam in Lesch-Nyhan patients as measured by standard clinical laboratory tests. The patients will also be observed and questioned about other side effects, such as whether they feel more or less tired.Standard clinical laboratory tests for liver, kidney and blood function were conducted. The normal ranges for each of these tests were different and are too numerous to be individually listed here. However, if any individual value were to be either three-times greater or lesser than the upper or the lower limit of the test, then that value was considered to have been changed.|Two weeks|All patients were analyzed|||Participants|||Number
2724435|NCT01065506|Primary|Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day|Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up|End of treatment (10 weeks post quit day) and 30-week follow-up|Participants who completed the end of treatment assessment|||number of participants|||Number
2724436|NCT01065480|Primary|Number of Participants With MI Skillfulness|MI skillfulness measured by the Motivational Interviewing Treatment Integrity Scale (MITI) on double coded audio recorded sessions and clinical interviews. The cumulative number of participants with MI Skillfulness at each time point assessed at 1, 8, 16, 24, and 32 weeks are reported.|1,8,16, 24 and 32 weeks||||Participants|||Count of Participants
2724437|NCT01065454|Secondary|Osteopontin - Change From Baseline to Week 16|Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||µg/mL||Standard Deviation|Mean
2724438|NCT01065454|Secondary|Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16|Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||µmol/L||Standard Deviation|Mean
2724439|NCT01065454|Secondary|Troponin T - Change From Baseline to Week 16|Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||µg/L||Standard Deviation|Mean
2724484|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724440|NCT01065454|Secondary|N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-pro BNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||pg/mL||Standard Deviation|Mean
2724441|NCT01065454|Secondary|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||ng/mL||Standard Deviation|Mean
2724442|NCT01065454|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16|The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The MLHF total score can range from 0 (best) to 105 (worst).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
2724443|NCT01065454|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
2724444|NCT01065454|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 (Nothing at all) to 10 (Extremely strong - Maximal)."|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
2724445|NCT01065454|Secondary|Percentage of Participants With Clinical Worsening|"The combined endpoint time to clinical worsening, made up of the following components, defined by the first occurrence: all cause mortality, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function."|At visit 6 (16 weeks)|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis.|||Percentage of participants|||Number
2724446|NCT01065454|Secondary|WHO (World Health Organization) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of PAH.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Percentage of participants|||Number
2724447|NCT01065454|Secondary|6-minute Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||m||Standard Deviation|Mean
2724448|NCT01065454|Secondary|Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16|E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||E/A ratio||Standard Deviation|Mean
2724449|NCT01065454|Secondary|E-wave Deceleration Time - Change From Baseline to Week 16|E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||msec||Standard Deviation|Mean
2724450|NCT01065454|Secondary|Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16|Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mL||Standard Deviation|Mean
2724451|NCT01065454|Secondary|Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16|Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mL||Standard Deviation|Mean
2724452|NCT01065454|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Percentage||Standard Deviation|Mean
2724453|NCT01065454|Secondary|Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16|Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
2724454|NCT01065454|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mm||Standard Deviation|Mean
2724455|NCT01065454|Secondary|Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16|Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
2724456|NCT01065454|Secondary|Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16|The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
2724457|NCT01065454|Secondary|Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16|The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
2724458|NCT01065454|Secondary|Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16|The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5||Standard Deviation|Mean
2724459|NCT01065454|Secondary|Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16|The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
2724460|NCT01065454|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5||Standard Deviation|Mean
2724461|NCT01065454|Secondary|Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16|The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Percentage||Standard Deviation|Mean
2724462|NCT01065454|Primary|Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF [safety analysis set]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
2724463|NCT01065428|Secondary|Neuromechanical Efficiency (NME)|NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).|at 30 minutes of the spontaneous breathing trials (SBT)||||cmH2O/uV||Standard Deviation|Mean
2724464|NCT01065428|Primary|Neuroventilatory Efficiency (NVE)|NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.|at 30 minutes of the spontaneous breathing trials (SBT)||||ml/uV||Standard Deviation|Mean
2724465|NCT01065350|Secondary|Average Change in Stroke Volume Variation (SVV)|SVV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. SVV is a dynamic flow-based parameter and together with cardiac output provides an indication of fluid responsiveness. The average change in SVV (as compared to baseline SVV) during the specified time intervals is reported. SVV is calculated by taking the SVmax - SVmin /*100/ SV mean.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 38/35 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Percentage of mean stroke volume||Standard Deviation|Mean
2724466|NCT01065350|Secondary|Average Change in Stroke Volume Index (SVI)|SVI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SVI (as compared to baseline SVI) during the specified time intervals is reported. To determine SVI, stroke volume is divided by the body surface area in order to account for body size.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Milliters per beat per m^2 of body area||Standard Deviation|Mean
2724467|NCT01065350|Secondary|Average Change in Stroke Volume (SV)|SV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SV from baseline during the specified time intervals is reported. SV is the milliliters of blood ejected during each contraction of the heart.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Milliliters of blood per beat||Standard Deviation|Mean
2724468|NCT01065350|Secondary|Average Change in Total Peripheral Resistance Index (TPRI)|TPRI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPRI from baseline during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/39 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||dynes * sec/cm^-5/m^2||Standard Deviation|Mean
2724469|NCT01065350|Secondary|Average Change in Total Peripheral Resistance (TPR)|TPR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPR from baseline during the specified time intervals is reported. TPR is the overall resistance to blood flow through the systemic blood vessels.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/38 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||dynes * sec/cm^-5||Standard Deviation|Mean
2724470|NCT01065350|Secondary|Average Change in Mean Arterial Pressure (MAP)|"MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in MAP from baseline during the specified time intervals is reported.~MAP is a term used in medicine to describe an average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 43/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2724471|NCT01065350|Secondary|Average Change in Diastolic Blood Pressure (DBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in DBP (as compared to baseline DBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction||||mmHg||Standard Deviation|Mean
2724472|NCT01065350|Secondary|Average Change in Systolic Blood Pressure (SBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SBP (as compared to baseline SBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction||||mmHg||Standard Deviation|Mean
2724473|NCT01065350|Secondary|Average Change in Heart Rate (HR)|HR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in HR (as compared to baseline HR) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction||||Beats per minute||Standard Deviation|Mean
2724485|NCT01065051|Secondary|Change in Peak Power Index During the Cardiopulmonary Exercise Tests|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. Formula: Peak Power Index = (SAPmean - PCWPmean)*CO*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724474|NCT01065350|Secondary|Average Change in Cardiac Index (CI)|"CI was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CI as compared to the baseline CI during the specified time intervals is reported.~To determine CI, cardiac output is divided by the body surface area in order to account for body size."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Liters per minute per m^2 of body area||Standard Deviation|Mean
2724475|NCT01065350|Secondary|Average Change in Cardiac Output (CO)|"CO was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CO as compared to baseline CO during the specified time intervals is reported.~CO is defined as the quantity of blood ejected per minute by the heart into the systemic circulation. It is the product of the heart rate (HR) (beats per minute) times the stroke volume (SV) (milliliters of blood ejected during each contraction)."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Liters per minute||Standard Deviation|Mean
2724476|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia|MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.|||Percentage of subjects|||Number
2724477|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.|||Percentage of subjects|||Number
2724478|NCT01065350|Primary|Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.|||Percentage of subjects|||Number
2724479|NCT01065051|Secondary|Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)|Ventilatory efficiency (V'E/V'CO2) and anaerobic threshold (AT) were parameters directly measured or derived by computed analysis from the spiroergometry system during the cardiopulmonary exercise test.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724480|NCT01065051|Secondary|Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests|The slope of the relationship between work rate during cardiopulmonary exercise tests and PAPmean is derived from the directly measured hemodynamic parameter mean pulmonary arterial pressure (PAPmean). PAPmean is acquired during a right heart catheterization.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724481|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak early diastolic velocity (E') is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724482|NCT01065051|Secondary|Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724483|NCT01065051|Secondary|Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests|The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2726287|NCT01050660|Secondary|Late Onset Sepsis|Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.|At the discharge from Newborn ICU||||participants who developed LOS|||Number
2724486|NCT01065051|Secondary|Change in End-systolic Elastance at Rest|The end-systolic elastance is a calculated hemodynamic parameter. It is approximated by the directly measured hemodynamic parameter end-systolic pressure divided by the directly measured echocardiography parameter left ventricular end-systolic volume (LVESV). The end-systolic pressure is acquired during a right heart catheterization. The LVESV is acquired during a non-invasive echocardiography examination. Approximated by end-systolic pressure/LVESV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724487|NCT01065051|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) at Rest|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724488|NCT01065051|Secondary|Change in Left Ventricular Stroke Work Index (LVSWI) at Rest|The left ventricular stroke work index (LVSWI) is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The LVSWI is also dependent of the calculated hemodynamic parameter stroke volume index (SVI). Formula: LVSWI = (SAPmean - PCWPmean)*SVI*0.0136|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724489|NCT01065051|Primary|Change in Peak Power Index at Rest|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)*CO [cardiac output]*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
2724490|NCT01064947|Secondary|Local Tolerability|"The investigator assessed the following characteristics on a grading scale of 0-3 (none, mild moderate or severe): erythema, inflammation, infection, crusting, necrosis, peeling, swelling and contact dermatitis.~The subject assessed the following characteristics on a scale of 0-3 (none, mild, moderate or severe): irritation, itchiness burning, tenderness and pain."|Day 7||||units on a scale||Inter-Quartile Range|Median
2724491|NCT01064947|Secondary|Investigator Assessment of Clinical Cure|The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default|Day 7||||participants|||Number
2724492|NCT01064947|Secondary|Skin Infection Rating Scale (SIRS)|The Primary Investigator rated the each of the following characteristics: exudate/pus, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain on a scale of 0-6 (absent-severe) to create an overall SIRS score ranging from 0-42.|Day 1 and Day 7||||units on a scale||Inter-Quartile Range|Median
2724493|NCT01064947|Primary|Bacteriological Culture|All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.|Day 1 and Day 7||||participants|||Number
2724494|NCT01064882|Secondary|Treatment Satisfaction Questionnaire Score at Month 3|The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).|Month 3|Modified Intent-to-Treat: All randomized subjects who were treated with the intended study medication and completed at least one follow-up visit.(Note: 2 subjects in the Bim 0.015% treatment group, 1 subject in the Bim 0.005% treatment group, and 1 subject in the Bim 0.03% treatment group did not have Month 3 visit data for this outcome measure)|||Scores on a Scale||Standard Deviation|Mean
2724495|NCT01064882|Secondary|Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3|Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.|||Scores on a Scale||Standard Deviation|Mean
2724496|NCT01064882|Secondary|Change From Baseline in Overall Eyelash Satisfaction at Month 3|"Change from baseline at Month 3 in question 3 overall, how satisfied are you with your eyelashes? Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline."|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.|||Scores on a Scale||Standard Deviation|Mean
2724497|NCT01064882|Secondary|Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3|Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.|Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.|||Percentage of Subjects|||Number
2726288|NCT01050660|Secondary|Incidence of Retinopathy of Prematurity (ROP)||At discharge from Newborn ICU||||participants who developed ROP|||Number
2724498|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3|Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)|||Units on a Scale||Standard Deviation|Mean
2724499|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Thickness at Month 3|Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)|||Millimeters squared (mm^2)||Standard Deviation|Mean
2724500|NCT01064882|Primary|Change From Baseline in Eyelash Length at Month 3|Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)|||millimeters (mm)||Standard Deviation|Mean
2724501|NCT01064856|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and with non-missing values for both Baseline and post-baseline visit.|||units on a scale||Standard Deviation|Mean
2724502|NCT01064856|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724503|NCT01064856|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724504|NCT01064856|Secondary|Change From Baseline in Dactylitis at Week 12|Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values for both Baseline and the post-baseline.|||units on a scale||Standard Deviation|Mean
2724505|NCT01064856|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12|Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2726289|NCT01050660|Secondary|Incidence of Necrotizing Enterocolitis (NEC)||At discharge from Newborn ICU||||participants who developed NEC|||Number
2724506|NCT01064856|Secondary|Change From Baseline in Leeds Enthesitis Index at Week 12|Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724507|NCT01064856|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724508|NCT01064856|Secondary|Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12|The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values.|||units on a scale||Standard Deviation|Mean
2724509|NCT01064856|Secondary|Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12|The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724510|NCT01064856|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724511|NCT01064856|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12|A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2724512|NCT01064856|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|Baseline (day of first study drug administration) through Week 156 plus 70 days|Safety Analyses included all participants who received at least 1 dose of double-blind study drug.|||participants|||Number
2724571|NCT01064687|Secondary|Change in Baseline to 26 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2724513|NCT01064856|Primary|Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12|Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.|Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).|||percentage of participants|||Number
2724514|NCT01064830|Secondary|Patients Assessment of Satisfaction With Length of Fingernails|"the percentages of participants who were satisfied with the length of fingernails"|20 weeks|all patients enrolled who completed this response measure at week 20.|||percentage of patients|||Number
2724515|NCT01064830|Primary|• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.|IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails|20 weeks||||patients|||Number
2724516|NCT01064817|Primary|Subjects With Safety Related Events or Findings|The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields|First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs||||participants|||Number
2724517|NCT01064817|Other Pre-specified|Bleb Scarring|Exploratory Efficacy Outcome measure: Bleb scarring is graded on a scale from 0-3. 0= none to minimal scarring, 1= mild, 2= moderate, 3= severe scarring.|Day 120|Number of subjects who had assessment of bleb scarring on Day 120|||units on a scale||Standard Deviation|Mean
2724518|NCT01064817|Other Pre-specified|Successful Intra-ocular Pressure (IOP) Control|Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP|Day 120||||participants|||Number
2724519|NCT01064817|Primary|Safety of Subconjunctival Injection|Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings|AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30|All subjects enrolled in study; all subjects received all study treatment|||Number of occurrences|||Number
2724520|NCT01064739|Secondary|Urinary Sodium|urinary sodium 8-12 hours after breakfast|8-12 hours after breakfast||||mEq/4hr||Standard Deviation|Mean
2724521|NCT01064739|Secondary|Urinary Sodium|Urinary sodium excreted 0-4 hours after breakfast.|0-4 hours after breakfast||||mEq/4hr||Standard Deviation|Mean
2724522|NCT01064739|Secondary|Supine Heart Rate|Supine heart rate 6 hours after breakfast|6 hours after breakfast||||beats per minute||Standard Deviation|Mean
2724523|NCT01064739|Secondary|Supine Systolic Blood Pressure|Supine systolic blood pressure 6 hours after breakfast|Supine-6 hours after breakfast on both study days.||||mm Hg||Standard Deviation|Mean
2724524|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 8-12 hours after breakfast|8 to 12 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
2724525|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 4-8 hours after breakfast|4 to 8 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
2724526|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 0-4 hours after breakfast|0 to 4 hours after breakfast||||micrograms/4 hours||Standard Deviation|Mean
2724527|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 8 to 12 hours after breakfast|8 to 12 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
2724528|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 4 to 8 hours after breakfast|4 to 8 hours after breakfast||||micrograms/4 hours||Standard Deviation|Mean
2724529|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 0 to 4 hours after breakfast|0 to 4 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
2724530|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|8-12 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
2724531|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|0-4 hours after breakfast||||ug/4hr||Standard Deviation|Mean
2724532|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 6 hours after breakfast|Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724533|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 4 hours after breakfast|4 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724534|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 2 hours after breakfast|2 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724535|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 1 hour after breakfast|1 hour after breakfast||||pg/mL||Standard Deviation|Mean
2724536|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 6 hours after breakfast|6 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724537|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 4 hours after breakfast|4 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724538|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 2 hours after breakfast|2 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724539|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 1 hour after breakfast|1 hour after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2726290|NCT01050660|Secondary|Incidence of Bronchopulmonary Dysplasia (BPD)||36 weeks PMA or discharge home,whichever comes first||||participants who developed BPD|||Number
2724540|NCT01064739|Secondary|Plasma Dopa 6 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 6 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724541|NCT01064739|Primary|Urinary Sodium|Urinary sodium excreted 4-8 hours after breakfast was designated as a primary outcome. Other urine samples (0-4 hr, 8-12 hr after breakfast) are considered as non-primary outcomes.|4 to 8 hours after breakfast||||mEq/4 hr||Standard Deviation|Mean
2724542|NCT01064739|Primary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|4-8 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
2724543|NCT01064739|Secondary|Plasma Dopa 4 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 4 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724544|NCT01064739|Secondary|Plasma Dopa 2 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 2 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724545|NCT01064739|Primary|Plasma Dopa 1 hr After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 1 hour after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
2724546|NCT01064713|Primary|Number of Participants With Response|Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.|Day 84||||participants|||Number
2724547|NCT01064713|Primary|Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)|Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.|Day 84||||percentage of participants|||Number
2724548|NCT01064687|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who were randomized at baseline to LY2189265 and received at least 1 dose of study drug with evaluable AUC data.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2724549|NCT01064687|Secondary|Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable NT-proBNP data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
2724550|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.|||||Standard Error|Least Squares Mean
2724551|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||||Standard Error|Least Squares Mean
2726291|NCT01050660|Secondary|Mortality Rate- Death Rate Before Discharge From the Hospital||Discharge from the Newborn ICU||||participants|||Number
2724552|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.|||participants|||Number
2724553|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||participants|||Number
2724554|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.|||participants|||Number
2724555|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 26 Weeks|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.|||participants|||Number
2724556|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.|||participants|||Number
2724557|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||participants|||Number
2724558|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
2724559|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
2724560|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.|||events|||Number
2724561|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||events|||Number
2724562|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Serum Calcitonin||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2724563|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Serum Calcitonin||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2724564|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter||Inter-Quartile Range|Median
2724565|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter||Inter-Quartile Range|Median
2724566|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.|||participants|||Number
2724567|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||participants|||Number
2724568|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Mean
2724569|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2724570|NCT01064687|Secondary|Change in Baseline to 52 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2724572|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable ECG QTcF Interval or PR Interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
2724573|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable ECG QTcF Interval or PR interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
2724574|NCT01064687|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. The number of participants with adjudicated CV events was not collected at 26 weeks.|||participants|||Number
2724575|NCT01064687|Secondary|Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable IW-SP data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724576|NCT01064687|Secondary|Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724577|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable APPADL data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724592|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
2726848|NCT01044745|Primary|Number of Participants With Grades II-IV Acute GVHD|Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.|At day 100||||Participants|||Count of Participants
2724578|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724579|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions|The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable DTSQs or DTSQc data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724580|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724581|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable EQ-5D data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724582|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
2724593|NCT01064687|Secondary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2724583|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
2724584|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
2724585|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2724586|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2724587|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable SMPG data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2724588|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable SMPG data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2724589|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable BMI data. Only pre-rescue measurements were used.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
2724590|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable BMI data. Only pre-rescue measurements were used.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
2724591|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
2724594|NCT01064687|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2724595|NCT01064648|Secondary|(Phase II) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment is repeated every 3 weeks while patient is on treatment.|Patients who received at least one dose of protocol treatment.|||Participants|||Number
2724596|NCT01064648|Secondary|(Phase I) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment is repeated weekly during first cycle (1cycle = 21 days), then every cycle while patient is on treatment.|Patients who received at least one dose of protocol treatment.|||Participants|||Number
2724597|NCT01064648|Secondary|Disease Control Rate by Modified RECIST (Phase II)|"Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA), does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA.~All target measurable lesions must be assessed using the same techniques as baseline."|Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control is documented for as long as the patient remains on protocol treatment.|Eligible patients with baseline measurable disease per modified RECIST were included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2724598|NCT01064648|Secondary|Response Rate by Modified RECIST (Phase II)|"Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline."|Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Best response is documented for as long as the patient remains on protocol treatment.|Eligible patients with baseline measurable disease per modified RECIST were included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2724599|NCT01064648|Secondary|Disease Control Rate by RECIST 1.1 (Phase II)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA~All target measurable lesions must be assessed using the same techniques as baseline."|Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control rate is documented for as long as the patient remains on protocol treatment.|Eligible patients with baseline eligible disease per RECIST 1.1 were included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2724600|NCT01064648|Secondary|Response Rate by RECIST1.1 (Phase II)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline."|Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years. Best response is documented for as long as the patient remains on protocol treatment.|Only eligible patients with baseline measurable disease per RECIST 1.1 were included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2724601|NCT01064648|Secondary|Overall Survival (Phase II)|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|From date of registration to death.Disease assessment will be repeated every 6 weeks until disease progression. After progression, follow up will occur every 6 months for the first two years and then at the end of the third year after registration.|Only eligible and analyzable patients are included in the analysis.|||month||95% Confidence Interval|Median
2724602|NCT01064648|Primary|Progression-free Survival (Phase II)|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions.|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression.|Only eligible and analyzable patients were included.|||month||95% Confidence Interval|Median
2724625|NCT01064531|Secondary|1 Year Postoperative Total Harris Hip Score (HHS)|The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.|1 year postoperative|Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy).|||Participants|||Count of Participants
2724603|NCT01064648|Primary|Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)|"MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting.~Febrile neutropenia~Grade 4 neutrophil count decrease for more than 7 days' duration~Grade 4 platelet count decrease~Grade 3 or 4 non-hematologic toxicity (excluding alopecia)"|Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment.||||mg|||Number
2724604|NCT01064622|Secondary|Activity (Overall Response Rate) in Crossover Patients|RECIST response rate in patients after crossover from placebo to vismodegib arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
2724605|NCT01064622|Secondary|Incidence of Adverse Events|Details are provided in Adverse Events section below. Reported here are percentage of patients in each arm with any grade 1 or higher adverse event, regardless of attribution.|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
2724606|NCT01064622|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
2724607|NCT01064622|Secondary|Overall Survival|Time from randomization to death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.|||months||95% Confidence Interval|Median
2724608|NCT01064622|Primary|Progression-free Survival|Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.|||months||95% Confidence Interval|Median
2724609|NCT01064531|Primary|Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement)|Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.|Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported|Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).|||degrees||Full Range|Mean
2724610|NCT01064531|Secondary|5 Years Postoperative Radiographic Assessments|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|5 years postoperative|Data from all enrolled hips who received a study device (17 MIS and 12 Synergy).|||Participants|||Count of Participants
2724611|NCT01064531|Secondary|3 Years Postoperative Radiographic Assessments|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|3 years postoperative|Data from all enrolled hips who received a study device (15 MIS and 13 Synergy).|||Participants|||Count of Participants
2724612|NCT01064531|Secondary|2 Years Postoperative Radiographic Assessments|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|2 years postoperative|Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).|||Participants|||Count of Participants
2724613|NCT01064531|Secondary|1 Year Postoperative Radiographic Assessments|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|1 year postoperative|Data from hips with all with RSA information at 1 year (20 MIS and 15 Synergy).|||Participants|||Count of Participants
2724614|NCT01064531|Secondary|3 Months Postoperative Radiographic Assessments|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|3 months postoperative|Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).|||Participants|||Count of Participants
2724615|NCT01064531|Secondary|Preoperative Radiographic Assessments|Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.|Preoperative|Data from all enrolled hips who received a study device (21 MIS and 20 Synergy).|||Participants|||Count of Participants
2724616|NCT01064531|Secondary|5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)|"The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.~Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points~Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms."|5 years postoperative|Data from hips with all with RSA information at 3 years (17 MIS and 12 Synergy).|||score on a scale||Standard Deviation|Mean
2724626|NCT01064531|Secondary|3 Months Postoperative Total Harris Hip Score (HHS)|The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.|3 months postoperative|Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).|||Participants|||Count of Participants
2724617|NCT01064531|Secondary|3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)|"The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.~Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points~Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms."|3 years postoperative|Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy).|||score on a scale||Standard Deviation|Mean
2724618|NCT01064531|Secondary|2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)|"The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.~Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points~Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms."|2 years postoperative|Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).|||score on a scale||Standard Deviation|Mean
2724619|NCT01064531|Secondary|1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)|"The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.~Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points~Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms."|1 year postoperative|Data from hips with all with RSA information at 1 year (21 MIS and 15 Synergy).|||score on a scale||Standard Deviation|Mean
2724620|NCT01064531|Secondary|3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS)|"The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.~Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points~Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms."|3 months postoperative|Data from hips with all with RSA information at 3 months (19 MIS and 16 Synergy).|||score on a scale||Standard Deviation|Mean
2724621|NCT01064531|Secondary|Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS)|"The HOOS was a questionnaire that the subject completed focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consisted of 40 items assessing 5 subscales; Symptoms and Stiffness, Pain, Function of Daily Living, Function in Sport and Recreation, and hip-related Quality of Life.~Pain included 10 items with a total score of 40 points Symptoms included 5 items with a total score of 20 points Function of Daily Living included 17 items with a total score of 68 points Function in Sport and Recreation included 4 items with a total score of 16 points Hip-related Quality of Life included 4 items with a total score of 16 points~Each subscore was transformed into a worst-to-best scale (0-100), where 100 indicated no symptoms and 0 indicated extreme symptoms."|Preoperative|Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy).|||score on a scale||Standard Deviation|Mean
2724622|NCT01064531|Secondary|5 Years Postoperative Total Harris Hip Score (HHS)|The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.|5 years postoperative|Data from hips with all with RSA information at 5 years (17 MIS and 12 Synergy).|||Participants|||Count of Participants
2724623|NCT01064531|Secondary|3 Years Postoperative Total Harris Hip Score (HHS)|The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.|3 years postoperative|Data from hips with all with RSA information at 3 years (15 MIS and 13 Synergy).|||Participants|||Count of Participants
2724624|NCT01064531|Secondary|2 Years Postoperative Total Harris Hip Score (HHS)|The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.|2 years postoperative|Data from hips with all with RSA information at 2 years (21 MIS and 16 Synergy).|||Participants|||Count of Participants
2724692|NCT01063972|Secondary|Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported|7-day point prevalence abstinence at 12 months, self-reported. Participants who did not respond were considered smokers.|12 months|Participants who were deceased or incarcerated at month 6 were excluded from the analysis.|||Participants|||Count of Participants
2724627|NCT01064531|Secondary|Preoperative Total Harris Hip Score (HHS)|The HHS is a physician tool to measure how a subject is doing after their hip was replaced. The HHS had a total range of 0-100 points and consisted of categories to assess Pain, Function, Absence of Deformity, Range of Motion, and Total Score. Each category was summarized and stratified into scores of Excellent (90-100), Good (80-89), Fair (70-79), Poor (60-69), and Very Poor (<60). Higher scores delineated better results for the subject.|Preoperative|Data from hips with all with RSA information at pre-operative visit (21 MIS and 20 Synergy).|||Participants|||Count of Participants
2724628|NCT01064531|Primary|Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement)|Migration, or micromovement of the implant, was measured using RSA to compare the modular, short hip stem called the MIS Stem against a standard THA using Synergy Hip System.|Discharge (baseline), 6 weeks, 3 and 6 months, 1 and 2 years postoperative, change from baseline at 2 years reported|Statistical comparisons were done using data from hips with all with RSA information at 2 years (20 MIS and 18 Synergy).|||mm||Full Range|Mean
2724629|NCT01064414|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2724630|NCT01064414|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2724631|NCT01064414|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2724632|NCT01064401|Secondary|Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks|The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of ≥ 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.|Baseline and 96 weeks|participants with a baseline and Week 96 assessment|||percentage of participants|||Number
2724633|NCT01064401|Secondary|Proportion of Participants Relapse-free at Week 144|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.|144 weeks||||proportion of participants|||Number
2724634|NCT01064401|Secondary|Proportion of Participants With Sustained Disability Progression at 144 Weeks|Sustained disability progression is defined as: at least a 1.0-point increase on the EDSS from Baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.|Baseline through 144 weeks||||proportion of participants|||Number
2724635|NCT01064401|Secondary|Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96|The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.|up to 96 weeks|participants with baseline and at least one post-baseline MRI measurement|||lesions||95% Confidence Interval|Mean
2724693|NCT01063972|Secondary|Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported|7-day point prevalence abstinence at 6 months, self-reported. Participants who did not respond were considered smokers.|6 months|Participants who were deceased or incarcerated at month 6 were excluded from the analysis.|||Participants|||Count of Participants
2724636|NCT01064401|Primary|Adjusted Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.|Up to 144 weeks|participants with a relapse|||relapses per person-years|Participants|95% Confidence Interval|Number
2724637|NCT01064362|Secondary|Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.|||participants|||Number
2724638|NCT01064362|Primary|Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.|||participants|||Number
2724639|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|1 hour after IPC||||nM||Standard Deviation|Mean
2724640|NCT01064323|Primary|Plasma S-nitrosothiols|nM|baseline||||nM||Standard Deviation|Mean
2724641|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|1 hour after IPC|Data was not collected for 1 participant for this outcome measure.|||nM||Standard Deviation|Mean
2724642|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|baseline|Data was not collected for 1 participant for this outcome measure.|||nM||Standard Deviation|Mean
2724643|NCT01064323|Primary|Plasma Nitrite|nM|1 hour after IPC||||nM||Standard Deviation|Mean
2724644|NCT01064323|Primary|Plasma Nitrite|nM|baseline||||nM||Standard Deviation|Mean
2724645|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, %|1 hour after IPC|Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.|||percentage of constriction||Standard Deviation|Mean
2724646|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, %|baseline|Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.|||percentage of constriction||Standard Deviation|Mean
2724647|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, mm|1 hour after IPC||||mm||Standard Deviation|Mean
2724648|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, mm|baseline||||mm||Standard Deviation|Mean
2724649|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, %|1 hour after IPC||||percentage of dilation||Standard Deviation|Mean
2724650|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, %|baseline||||percentage of dilation||Standard Deviation|Mean
2724651|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, mm|1 hour after IPC||||mm||Standard Deviation|Mean
2724652|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, mm|baseline||||mm||Standard Deviation|Mean
2724653|NCT01064323|Primary|Brachial Diameter|mm|1 hour after leg IPC||||mm||Standard Deviation|Mean
2724654|NCT01064323|Primary|Brachial Diameter|mm|baseline||||mm||Standard Deviation|Mean
2724655|NCT01064323|Primary|Brachial Flow Velocity|Measured using ultrasound, units cm/sec.|50 minutes into IPC||||cm/sec||Standard Deviation|Mean
2724656|NCT01064323|Primary|Brachial Flow Velocity|Measured using ultrasound, units cm/sec.|5 minutes into leg intermittent pneumatic compression||||cm/sec||Standard Deviation|Mean
2724657|NCT01064323|Primary|Brachial Flow Velocity|Brachial flow velocity measured using ultrasound. Units cm/sec.|Baseline||||cm/sec||Standard Deviation|Mean
2724658|NCT01064310|Secondary|Change From Baseline (BL) in Heart Rate|Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.|||Beats per minute||Standard Deviation|Mean
2724659|NCT01064310|Secondary|Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)|When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2724660|NCT01064310|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.|||participants|||Number
2724661|NCT01064310|Secondary|Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population|||participants|||Number
2724662|NCT01064310|Secondary|Number of Participants With the Indicated Reason for Receiving a Dose Reduction|Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|"Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated. Participants may be counted multiple times for the same reason for a dose reduction if the participant had multiple reductions for the same reason."|||participants|||Number
2724663|NCT01064310|Secondary|Number of Participants With the Indicated Number of Dose Reductions|Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.|||participants|||Number
2724664|NCT01064310|Secondary|Time to Dose Modification|For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.|||weeks||95% Confidence Interval|Median
2724665|NCT01064310|Secondary|Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores|The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])|Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.|||Scores on a scale||Standard Deviation|Mean
2724666|NCT01064310|Secondary|Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score|Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.|Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])|Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.|||Scores on a scale||Standard Deviation|Mean
2724667|NCT01064310|Primary|"Number of Participants Answering Yes, no, or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire"|The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|mITT Population. Responses to some categories of the PPQ may be missing for some participants.|||participants|||Number
2724668|NCT01064310|Primary|Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)|The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.|||participants|||Number
2724669|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.|||infants|||Number
2724670|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.|||infants|||Number
2724671|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received|The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.|||infants|||Number
2724672|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.|||infants|||Number
2724673|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.|||infants|||Number
2724674|NCT01064297|Primary|Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.|||infants|||Number
2724694|NCT01063972|Secondary|Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported|7-day point prevalence abstinence at 3 months, self-reported. Participants who did not respond were considered smokers.|3 months|Participants who were deceased or incarcerated at month 3 were excluded from analysis.|||Participants|||Count of Participants
2725097|NCT01059903|Secondary|Mean Residence Time (MRT) of Unconjugated Rotigotine|The MRT is the mean residence time.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||hours (h)||Standard Deviation|Mean
2724675|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of live births, fetal deaths with pregnancy loss occurring >=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to the lamotrigine polytherapy without valproate|||infants|||Number
2724676|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate.|||infants|||Number
2724677|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy.|||infants|||Number
2724678|NCT01064284|Secondary|To Evaluate the Incidence of All Other Adverse Events Related and Not Related to the Products Used||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed||||||
2724679|NCT01064284|Secondary|To Evaluate Laboratory Factors Potentially Associated to Inhibitor Development||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed||||||
2724680|NCT01064284|Secondary|To Evaluate Clinical Factors Potentially Associated to Inhibitor Development||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed||||||
2724681|NCT01064284|Secondary|To Evaluate the Modality of Occurrence of Inhibitors (Titre at Onset)|Inhibitor Titre at Onset|During 6 months of observation, from the inhibitor occurrence||||Bethesda Units||Full Range|Median
2724682|NCT01064284|Secondary|To Evaluate the Modality of Occurrence of Inhibitors (Number of EDs)|Number of EDs: Number of Exposure Days (EDs) after which the inhibitors develop|During the first 50 exposure days or first 3 years of enrollment, whichever occurs first||||Exposure days||Full Range|Median
2724683|NCT01064284|Secondary|To Evaluate the Frequency of Transient Inhibitors|Number of participants for each group who developed transient inhibitors (this means, those inhibitors which disappeared spontaneously within 6 months without immunotolerance treatment).|In the 6 months after inhibitor development|Data at 6‑month follow‑up were missing for two patients assigned to plasma‑ derived factor VIII and three patients assigned to recombinant factor VIII.|||participants|||Number
2724684|NCT01064284|Secondary|To Evaluate the Anamnestic Response of Inhibitor Patients||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed.||||||
2724685|NCT01064284|Primary|To Assess the Immunogenicity of Plasma Derived VWF/FVIII and rFVIII Concentrates by Determining the Frequency of Inhibitor Development in the First 50 EDs or in the First 3 Years From Enrolment, Whichever Comes First in PUPs and MBCTs|"Expressed with the numebr of patients for each group who developed FVIII inhibitors.~PUPs: Previously Untreated Patients MBCTPs: Minimally Blood Component-Treated Patients"|During the first 50 exposure days or first 3 years of enrollment, whichever occurs first||||participants||95% Confidence Interval|Number
2724686|NCT01064167|Secondary|Postoperative Chest Tube Drainage||24h postoperative||||ml||Standard Deviation|Mean
2724687|NCT01064167|Primary|Number of Patients Required Allogenic Red Blood Cells Transfusion||1month postoperative|As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.|||participants|||Number
2724688|NCT01064076|Primary|Percentage of Participants Who Pass Induced VF Conversion Test|Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.|Implant/Pre-Discharge|304 subjects had a complete VF conversion test recorded|||percentage of participants||95% Confidence Interval|Number
2724689|NCT01064076|Primary|Percentage of Participants Free of Type I Complications at 180 Days.|Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.|180 days|The analysis cohort includes all subjects undergoing an implant attempt.|||percentage of participants||95% Confidence Interval|Number
2724690|NCT01063972|Secondary|Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months||12 months|Includes only participants eligible to enter into Cycle 2 counseling (those who reported smoking at month 6). Excludes participants who were deceased or incarcerated at month 12, or who did not report on pharmacotherapy use.|||Participants|||Count of Participants
2724691|NCT01063972|Secondary|Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months||6 months|Excludes participants who were deceased or incarcerated at month 6, or who did not report on pharmacotherapy use.|||Participants|||Count of Participants
2725209|NCT01059760|Primary|Change From Baseline in Participant Adiponectin When Fasting and Fed||Baseline and 3 days||||ratio of high molecular to total||Standard Deviation|Mean
2724696|NCT01063907|Secondary|Phase 1: PK Elimination t½ hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.|||hr||Standard Deviation|Mean
2724697|NCT01063907|Secondary|Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.|||hr*ng/mL||Standard Deviation|Mean
2724698|NCT01063907|Secondary|Phase 1: PK Exposure Cmax ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.|||ng/mL||Standard Deviation|Mean
2724699|NCT01063907|Secondary|Phase 1: PK Absorption Tmax hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.|||hr||Standard Deviation|Mean
2724700|NCT01063907|Primary|To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).|"The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.~The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).~Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized)."|21 day cycle, up to 52 weeks|All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.|||participants|||Number
2724701|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724702|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Disease Type)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724703|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Dosage)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which subgroup by dosage was categorized based on dose-titration patterns observed during the course of the treatment period."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724704|NCT01063881|Secondary|Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better? The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724705|NCT01063881|Secondary|The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely? The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724706|NCT01063881|Secondary|The Patient's Level of Personal Distress Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation. Patient's were asked: Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely. The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724707|NCT01063881|Secondary|The Patient's Level of Satisfaction With Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale. Patients were asked: Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good? The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724708|NCT01063881|Secondary|The Patient's Level of Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good? The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724709|NCT01063881|Primary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment"|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better? The number of patients who described improvement with their PE of at least slightly better after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
2724710|NCT01063868|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|Entire Study|Safety analysis set (All randomized participants who took at least one dose of study medication).|||participants|||Number
2724711|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Slightly Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better. The percentage of patients who reported improvement in PE of at least slightly better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724712|NCT01063855|Secondary|The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 1-category decrease (improvement) in interpersonal difficulty related to ejaculation is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724713|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better. The percentage of patients who reported improvement in PE of at least better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724714|NCT01063855|Secondary|The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater increase in satisfaction with sexual intercourse is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724727|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).|||percentage of participants||95% Confidence Interval|Number
2724715|NCT01063855|Secondary|The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation and control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported a composite score of at least a 2-category increase in control over ejaculation and at least a 1-category decrease (improvement) in personal distress is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724716|NCT01063855|Secondary|The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater decrease (improvement) in personal distress related to the speed of ejaculation is provided in the table below."|At Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724717|NCT01063855|Secondary|The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 2-category increase in control over ejaculation is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
2724718|NCT01063855|Primary|The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12|The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.|Baseline, Week 12|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||minutes||Standard Deviation|Mean
2724719|NCT01063829|Secondary|Number of Patients With Systemic Detectable HCMV Replication.||84 days||||Participants|||Count of Participants
2724720|NCT01063829|Primary|"Time to Onset of HCMV Prophylaxis Failure"||84 days||||days|||Number
2724721|NCT01063829|Primary|"Number of Participants With HCMV Prophylaxis Failure"||84 days||||Participants|||Count of Participants
2724722|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)|"The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented.~Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7."|From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)|Full Analysis Set (FAS).|||Percent reduction||Inter-Quartile Range|Median
2724723|NCT01063764|Secondary|Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).|||participants|||Number
2724724|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 10-weeks Evaluation Period|"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.|||participants|||Number
2724725|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 14-weeks Treatment Period|"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).|||participants|||Number
2724726|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.|||percentage of participants||95% Confidence Interval|Number
2724748|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the Overall Study Population|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population - randomised patients having measurable disease at baseline.|||Percent change||Standard Deviation|Mean
2724728|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period|"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.|||Seizures per week||Inter-Quartile Range|Median
2724729|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.|||Seizures per week||Inter-Quartile Range|Median
2724730|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period|"The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data at Baseline and during the Evaluation Period.|||Percent reduction||95% Confidence Interval|Median
2724731|NCT01063764|Primary|Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).|||percentage of participants|||Number
2724732|NCT01063764|Primary|Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:~(B values- T values) / B values x 100.~Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22|Full Analysis Set (FAS).|||Percent reduction||95% Confidence Interval|Median
2724733|NCT01063712|Secondary|Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography.|The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.|one year after percutaneous closure|"The patient selection was based in the consecutive case and intention to treat method. All patients recruited in the determinated time frame (June 2009 to May 2010) who met the initial inclusion criteria were treated in the catheterisation laboratory. There the definite inclusion criteria were applied."|||participants|||Number
2724734|NCT01063712|Primary|Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)|The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.|up to one year after percutaneous closure|"29 patients were controled in a period of one year and were examinated by echocardiography.The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."|||Participants|||Number
2724735|NCT01063595|Secondary|Concentration of Plasmin Inhibitor|Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.|From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.|||Percentage inhibition||Standard Deviation|Mean
2724822|NCT01062841|Primary|Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of MRSA isolates|||Number
2725210|NCT01059760|Primary|Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed||Baseline and 3 days||||ng/mL||Standard Deviation|Mean
2724736|NCT01063595|Primary|Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C|Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.|||Percentage change||Standard Deviation|Mean
2724737|NCT01063595|Primary|Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI|Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.|||Percentage change||Standard Deviation|Mean
2724738|NCT01063517|Secondary|Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724739|NCT01063517|Secondary|Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724740|NCT01063517|Secondary|Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724741|NCT01063517|Secondary|Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724742|NCT01063517|Secondary|Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724743|NCT01063517|Secondary|Time to Deterioration in QoL Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having pain domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724744|NCT01063517|Secondary|Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724745|NCT01063517|Secondary|Time to Deterioration in QoL Fatigue Score in the Overall Study Population|Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having fatigue score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724746|NCT01063517|Secondary|Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population|Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having global score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
2724747|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.|||Percent change||Standard Deviation|Mean
2724749|NCT01063517|Secondary|Objective Response Rate (ORR) in the ATM Negative Patients|Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.|||Participants|||Number
2724750|NCT01063517|Secondary|Objective Response Rate (ORR) in the Overall Study Population|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population - randomised patients having measurable disease at baseline.|||Participants|||Number
2724751|NCT01063517|Secondary|Overall Survival (OS) in ATM Negative Patients|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients|||months||Inter-Quartile Range|Median
2724752|NCT01063517|Secondary|Overall Survival (OS) in the Overall Study Population|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including all randomised patients|||months||Inter-Quartile Range|Median
2724753|NCT01063517|Primary|Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients|||months||Inter-Quartile Range|Median
2724754|NCT01063517|Primary|Progression Free Survival (PFS) in the Overall Study Population|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including all randomised patients|||months||Inter-Quartile Range|Median
2724755|NCT01063348|Secondary|Skin Picking Self Assessment Scale (SP-SAS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score."|Once every three weeks for the duration of the 12 week study for each subject||||units on a scale||Standard Deviation|Mean
2724756|NCT01063348|Primary|Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported."|Once every three weeks during the 12 week study for each subject||||units on a scale||Standard Deviation|Mean
2724757|NCT01063283|Secondary|Progression Free Survival|Time to progression or death from any cause, whichever comes first|2 years|Because the study did not meet its accrual goals, the study team did not proceed to collect this secondary outcome measure. The data were not collected and therefore are not available to report.||||||
2724758|NCT01063283|Secondary|Change in Tumor Size From Baseline||2 years|Because the study did not meet its accrual goals, the study team did not proceed to collect this secondary outcome measure. The data were not collected and therefore are not available to report.||||||
2724759|NCT01063283|Secondary|Response Rate|Percentage of patients with a complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||Participants|||Count of Participants
2724760|NCT01063283|Primary|Change in 24 Hour Diastolic Blood Pressure (DBP)|The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1|2 cycles||||mmHg||Standard Deviation|Mean
2724761|NCT01063153|Primary|Percent Errors in Visual Go/NoGo Task|The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group.|Single Point (Baseline)|Only subjects that met the a priori pre-defined EEG signal quality criteria were included.|||percentage of errors|||Number
2724823|NCT01062841|Secondary|Number of First Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only a urinary catheter present and >1 follow-up visit|||Number of First CAUTI|Participants||Number
2724762|NCT01063153|Primary|Adult ADHD Investigator Symptom Rating Scale (AISRS)|An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.|Baseline and 6 weeks|Subjects in the ADHD group who completed all 6 weeks of the trial were included in data analysis. Subjects who completed at least 3 weeks of treatment were also included regardless of the reason for withdrawal, and final-visit AISRS scores were used in ITT (intent-to-treat) analysis via last observation carried forward [LOCF] imputation.|||units on a scale||Standard Deviation|Mean
2724763|NCT01063075|Primary|Cetuximab PK: Confirmatory Serum Concentration||Group D: Prior to Carboplatin Infusion, Cycle 1, Day 1|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. Study design by intent did not collect data from Groups A, B, and C.|||micrograms per milliliters (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2724764|NCT01063075|Primary|Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.|||Hour (h)||Full Range|Median
2724765|NCT01063075|Primary|Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.|||Hour (h)||Full Range|Median
2724766|NCT01063075|Primary|Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2724767|NCT01063075|Primary|Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2724768|NCT01063075|Primary|Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.|||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2724769|NCT01063075|Primary|Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.|||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2724770|NCT01063062|Secondary|Number of Participants With Elevated Triglyceride According to ATPIII Guidelines|Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2724771|NCT01063062|Secondary|Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2724772|NCT01063062|Secondary|Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60). The number of participants with category High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2726545|NCT01048424|Secondary|Change in Incontinence- or Bladder-specific Quality of Life|Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
2724773|NCT01063062|Secondary|Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines|Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240). The number of participants categorized Borderline High or High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2724774|NCT01063062|Secondary|Number of Participants With Elevated AST (SGOT) and ALT (SGPT)|Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory. The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported.|Week 24|Participants from the safety population, all participants who received study drug and had at least 1 post-dose safety assessment, with data available for analysis.|||participants|||Number
2724775|NCT01063062|Secondary|Number of Participants With Serious Infections|A serious infection was an infection that qualified as a Serious Adverse Event (SAE). A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2724776|NCT01063062|Secondary|Number of Participants With AE and SAE Related Discontinuation|The number of participants who stopped using the study drug because of an AE or a SAE. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2724777|NCT01063062|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
2724778|NCT01063062|Secondary|Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory. ESR was measured in millimeters/hour (mm/hr).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time point. Last observation carried forward.|||mm/hr||Standard Deviation|Mean
2724779|NCT01063062|Secondary|C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had data for at least one follow-up variable, with data available for the given timepoint.|||mg/L||Standard Deviation|Mean
2724780|NCT01063062|Secondary|Disease Activity Score 28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time-point. Last observation carried forward.|||score on a scale||Standard Deviation|Mean
2724781|NCT01063062|Secondary|Time to DAS28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||days||95% Confidence Interval|Mean
2724782|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Remission|DAS28 Remission was defined as a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||percentage of participants|||Number
2726568|NCT01047839|Secondary|SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)||at Day 56 and Month 7|||||||
2724783|NCT01063062|Secondary|Time to DAS28 Clinically Significant Improvement|Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||days||95% Confidence Interval|Mean
2724784|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Clinically Significant Improvement|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Baseline, Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||percentage of participants|||Number
2724785|NCT01063062|Primary|Time to DAS28 Low Disease Activity|Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received at least one dose of study drug and had data for at least one follow-up variable available. Last observation carried forward.|||days||95% Confidence Interval|Mean
2724786|NCT01063062|Primary|Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)|Intent-to-treat (ITT) population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward was applied for missing data.|||percentage of participants|||Number
2724787|NCT01063049|Secondary|The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature|Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).|After Colonoscopy||||units on a scale||Standard Deviation|Mean
2724788|NCT01063049|Primary|The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale|The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).|After Colonoscopy||||units on a scale||Standard Deviation|Mean
2724789|NCT01063036|Secondary|Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population|Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|N=treated participants with on-treatment laboratory test results.|||participants|||Number
2724790|NCT01063036|Secondary|Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population|Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant's sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant's sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy.|Baseline to Weeks 48, 96|All treated participants who met resistance testing criteria (primary non-response or virologic breakthrough) and were tested for resistance to both study drugs were analyzed. n = number of participants analyzed at Weeks 48 and 96.|||participants|||Number
2724791|NCT01063036|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|All Treated participants were analyzed.|||participants|||Number
2724824|NCT01062841|Primary|Total Number of MDRO (Multidrug Resistant Organisms) Isolated|Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period|From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Residents enrolled with >1 follow-up visit|||Total Number of MDRO isolates|||Number
2724792|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline|HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724793|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline|Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48, and 96 (NC = F). An exact binomial 95% Confidence Interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724794|NCT01063036|Secondary|Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline|HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724795|NCT01063036|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline|Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline to Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724796|NCT01063036|Secondary|Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population|HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F).|Weeks 24, 48, 96|All treated participants were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724797|NCT01063036|Secondary|Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population|HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration.|Baseline to Weeks 12, 24, 48, 96|All treated participants with results at both baseline and on-treatment were analyzed. n=Number of treated participants with results at baseline and Week 12, Week 24, Week 48 and Week 96.|||log10 IU/mL||Standard Deviation|Mean
2724798|NCT01063036|Secondary|Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 24, Week 96|All treated participants were analyzed at Weeks 24 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724825|NCT01062763|Primary|Change of Diastolic Blood Pressure|Change of diastolic blood pressure from baseline to study end at four months.|4 months|Analyzed by intention to treat and last observation carried forward|||mm Hg||95% Confidence Interval|Mean
2724826|NCT01062763|Secondary|Adverse Effects||4 months|Intention to treat|||participants|||Number
2724799|NCT01063036|Primary|Percentage of Participants With a Virologic Response at Week 48 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 48|All treated participants were analyzed (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
2724800|NCT01062971|Secondary|Number of Adverse Events|the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event.|basal (day 1 ) and security call (day 75)|the analysis of the study groups was done by protocol|||events|||Number
2724801|NCT01062971|Primary|Intraocular Pressure (IOP)|the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.|basal (day 1 ) and final (day 60)|the analysis of the groups was by protocol|||mmHg||Standard Deviation|Mean
2724802|NCT01062893|Secondary|Time for Regression of Motor Blockade||up to 20 minutes|No data collected||||||
2724803|NCT01062893|Secondary|Time for 2 Dermatome Level Regression of Sensory Block||up to 20 minutes|No data collected||||||
2724804|NCT01062893|Secondary|Number of Participants Who Had Occurrence of Post Dural Puncture Headache||length of labor, up to 24 hours||||Participants|||Count of Participants
2724805|NCT01062893|Secondary|Number of Participants Who Had Occurrence of Itching||length of labor, up to 24 hours||||Participants|||Count of Participants
2724806|NCT01062893|Secondary|Occurrence of Use of Vasopressors||length of labor, up to 24 hours||||Participants|||Count of Participants
2724807|NCT01062893|Secondary|Number of Participants Who Had Occurrence of Maternal Hypotension||length of labor, up to 24 hours||||Participants|||Count of Participants
2724808|NCT01062893|Secondary|Number of Participants Who Had Occurrence of Fetal Bradycardia|occurrence of common side effects of spinal/epidural administration|length of labor, up to 24 hours||||Participants|||Count of Participants
2724809|NCT01062893|Secondary|Time to Highest Sensory Block||up to 20 minutes||||minutes||Standard Deviation|Mean
2724810|NCT01062893|Secondary|Onset of Analgesia|time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable|up to 20 minutes||||minutes||Standard Deviation|Mean
2724811|NCT01062893|Secondary|Duration of Analgesia (Time to Request Additional Analgesia)|time of CSE to time request of additional supplement analgesia in minutes|up 120 minutes||||minutes||Standard Deviation|Mean
2724812|NCT01062893|Primary|Highest Sensory Blockade Level to Pinprick and to Cold|Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)|up to 20 minutes||||units on a scale||Standard Deviation|Mean
2724813|NCT01062841|Secondary|Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)|||Number of Residents with New R-GNB|Participants||Number
2724814|NCT01062841|Secondary|Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with > 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)|||Number of Residents with New VRE|Participants||Number
2724815|NCT01062841|Secondary|Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)|||Number of Residents with New MRSA|Participants||Number
2724816|NCT01062841|Secondary|Number of Incident Feeding-tube Associated Pneumonias||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with indwelling feeding tube present (PEG tube), and had >1 follow-up visit|||Number of feeding-tube associated pneu|Participants||Number
2724817|NCT01062841|Secondary|Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with an indwelling feeding tube present (PEG tube), and had >1 follow-up visit|||Numer of feeding-tube SSTIs|Participants||Number
2724818|NCT01062841|Secondary|Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only an indwelling urinary catheter present and >1 follow-up visit|||Number of CAUTI|Participants||Number
2724819|NCT01062841|Primary|Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of Ciprofloxacin-RGNB|||Number
2724820|NCT01062841|Primary|Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of Ceftazidime-RGNB isolate|||Number
2724821|NCT01062841|Primary|Total Number of VRE (Vancomycin Resistant Enterococci) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of VRE isolates|||Number
2724832|NCT01062425|Secondary|Progression-free Survival (PFS)|Progression-free survival time is defined as time from randomization to date of first progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are censored at the date of last contact. Progression is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.|||Months||95% Confidence Interval|Median
2724833|NCT01062425|Secondary|Overall Survival (OS)|OS will be estimated using the Kaplan-Meier method and differences between treatment arms will be tested using the log rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors.|From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.|||Months||95% Confidence Interval|Median
2724834|NCT01062425|Primary|6-month Progression-free Survival Rate|Six-month progression-free survival is the rate of patients who have NOT progressed at six months, where progressive disease is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. Progression will be determined by central review of MRI exams, assessed using MacDonald criteria for progression versus response on 2D T1 and T2 weighted images.|From randomization to 6 months.|Randomized eligible patients with evaluable data at six months. (From the randomized eligible patients, 2 patients withdrew prior to 6 months and 1 did not have an evaluable scan on the placebo arm, while 4 withdrew before 6 months, 3 did not have an evaluable scan, and 2 did not receive protocol treatment on the cediranib arm.)|||percentage of participants||95% Confidence Interval|Number
2724835|NCT01062399|Secondary|Phase II: Distribution of Worst Adverse Event Grade|The worst/highest grade of any adverse event reported was determined for each patient. The percentage of patients in each grade level is reported. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase II patients who started study treatment and had adverse events assessed.|||percentage of patients|||Number
2724836|NCT01062399|Secondary|Phase I: Distribution of Worst Adverse Event Grade|"AE reporting in Phase I was split up by treatment timing: concurrent treatment (RT, TMZ, RAD001); post-RT treatment (TMZ, RAD001) along with all AE's reported in follow-up.~The worst/highest grade of any adverse event reported in each time period was determined for each patient. The percentage of patients in each grade level is reported. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE."|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase I patients who started the corresponding study treatment and had adverse events assessed.|||percentage of participants|||Number
2724837|NCT01062399|Secondary|Phase II: Overall Survival (OS)|Overall survival time is defined as time from/randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase II patients|||months||95% Confidence Interval|Median
2724838|NCT01062399|Primary|Phase II: Progression-free Survival (PFS)|Using the Response Assessment in Neuro- Oncology (RANO) criteria, the progression is defined by any of the following: > 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease. PFS time is defined as time from registration to date of progression, death, or last known follow-up (censored). PFS rates are estimated using the Kaplan-Meier method.|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase II patients|||months||95% Confidence Interval|Median
2724839|NCT01062399|Primary|Phase I: Number of Patients With Dose-limiting Toxicity (DLT)|DLT is defined as any of the following events occurring during the first 8 weeks of treatment with RAD001 and temozolomide and attributable to the study drugs: any grade 3 or 4 thrombocytopenia, grade 4 anemia, or grade 4 neutropenia lasting more than 7 days; any non-hematologic grade 3 or greater adverse event (AE), excluding alopecia, despite maximal medical therapy; any grade 4 radiation-induced skin changes; failure to recover from adverse events to be eligible for re-treatment with RAD001 and temozolomide within 14 days of the last dose of either drug; or any episode of non-infectious pneumonitis grade 2, 3, or 4 of any duration. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to eight weeks.|First 6 eligible phase I patients at each dose level who started study treatment|||Participants|||Count of Participants
2724840|NCT01062308|Secondary|Passive Range of Motion (ROM)|Passive range of motion (ROM) of shoulder was measured with full circle goniometer. The normal range of movement of flexion and abduction is 180 degree.|14 days and 30 days|On the basis of follow up completion|||degree||95% Confidence Interval|Mean
2724841|NCT01062308|Primary|Pain: Visual Analog Scale|"Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 (No Pain) to 100 (Worst Pain Imaginable) Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability"|14 days and 30 days|On the basis of complete follow up|||mm||95% Confidence Interval|Mean
2724842|NCT01062269|Secondary|Weighted vs. Unweighted BASA Scale|The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4.|1 Day||||Units on Scale||Standard Deviation|Median
2724843|NCT01062269|Primary|Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.|The Bile Acid Sequestrant Acceptability Scale has 4 scoring categories: taste, texture, appearance and mixability. Participants rank each category separately. The best possible score for each category is 5 and the worst possible score is 1.|1 Day|Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.|||Units on Scale||Standard Deviation|Mean
2724844|NCT01062256|Other Pre-specified|Number of Participant With Cough Severity|Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate.|Baseline|ITT|||Participants|||Number
2724845|NCT01062256|Secondary|Number of Participants With Global Evaluation of Study Medication|"Participant-rated evaluation of study product; Participants responded to the following question:~How would you rate this product as a cough reliever? 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent"|4 hours postdose or early termination|ITT|||participants|||Number
2724846|NCT01062256|Secondary|Change From Baseline in Cough Severity Scale|Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement.|1, 2, 3, and 4 hours postdose|ITT|||units on a scale||Standard Deviation|Mean
2724847|NCT01062256|Secondary|Number of Cough Bouts Within Each 15-minute Time Interval Postdose|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.|every 15 minutes postdose up to 240 minutes postdose|ITT|||cough bouts||Standard Deviation|Mean
2724848|NCT01062256|Secondary|Number of Cough Bouts Over 2-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 2 hours postdose|ITT|||cough bouts||Standard Deviation|Mean
2724849|NCT01062256|Primary|Number of Cough Bouts Over 4-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 4 hours postdose|Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product.|||Cough bouts||Standard Deviation|Mean
2724850|NCT01062230|Primary|Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1|All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.|Baseline and Day 1||||% change|||Number
2724851|NCT01062165|Primary|Total Clearance of Caspofungin||0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)||||L/hr||Standard Deviation|Mean
2724852|NCT01062113|Secondary|Differences in Pain Intensity (PI) Measured by VAS Among Participants|The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.|Pre-additional dose (baseline) and 2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).|||mm||Standard Deviation|Mean
2724853|NCT01062113|Secondary|Pain Intensity Measured by Visual Analog Scale (VAS)|The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.|2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).|||mm||Standard Deviation|Mean
2724854|NCT01062113|Secondary|Number of Participants in Each Pain Intensity (PI) With 4 Categories|"Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain."|2 hours after additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).|||participants|||Number
2724855|NCT01062113|Primary|Efficacy Rate (Percentage) of Patient's Impression|"Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent,  Good, Fair and Poor.~Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100."|2 hours post-additional dose|The full analysis set (FAS). This analysis set consisted of randomized participants who received the additional dose of the study drug and who were assessed for at least one efficacy endpoint after randomization.|||percentage of participants|||Number
2724856|NCT01062074|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol|||Percent of participants|||Number
2724857|NCT01062074|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol|||Percent of participants|||Number
2724858|NCT01062061|Primary|Percentage of Participants With One or More Unexpected SAEs|Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination||||percentage of participants|||Number
2724859|NCT01062061|Primary|Percentage of Participants With One or More Serious ADRs|A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724860|NCT01062061|Primary|Percentage of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.|Up to 42 days after vaccination|SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724861|NCT01062061|Primary|Percentage of Participants With One or More Unexpected ADRs|An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out|Up to 42 days after vaccination|Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724862|NCT01062061|Primary|Percentage of Participants With One or More Unexpected AEs|Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination|Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724863|NCT01062061|Primary|Percentage of Participants With One or More Adverse Drug Reactions (ADRs)|An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724864|NCT01062061|Primary|Percentage of Participants With One or More AEs by Age|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724865|NCT01062061|Primary|Percentage of Participants With One or More AEs by Gender|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
2724866|NCT01062061|Primary|Percentage of Participants With One or More Adverse Events (AEs)|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||Percentage of Participants|||Number
2726569|NCT01047839|Secondary|Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and up to Month 7|||||||
2724867|NCT01062009|Secondary|Glucose Homeostasis|Patients were assigned a score based on glucose range to take into account the degree of hyperglycemia as well as the need for insulin over the course of the 7 day study period. This score is an ordinal scale ranging from 1 to 5, with a score of 1 indicating no hyperglycemia, and 5 indicating severe hyperglycemia despite insulin administration.|7 days||||units on a scale||Inter-Quartile Range|Median
2724868|NCT01062009|Primary|New Fever|Because of reports of fever in patients wiht zinc overdoses, we monitored patients for new fever while on supplementation|7 days||||participants|||Number
2724869|NCT01062009|Primary|Plasma Zinc Concentration Over Time|Plasma Zinc levels were measured daily during the seven day study period in each group.|7 days||||mcg/dL||Standard Deviation|Mean
2724870|NCT01061866|Primary|Change From Baseline in the Mean Number of Daily Seizures at 1 Year.||Baseline 3 months and 1 year of treatment|males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study|||Number of Seizures||Standard Error|Mean
2724871|NCT01061775|Secondary|Calorie Intake Based on 3-day Diet Records|Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.|24 weeks|The sample size was small due to missing data|||kcals||95% Confidence Interval|Mean
2724872|NCT01061775|Secondary|Childhood Eating Behavior Questionnaire (CEBQ)|The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.|24 weeks|Paired t-tests were performed to compare the satiety survey (continuous). Three subjects discontinued prior to completing the Week 24 CEBQ.|||units on a scale||95% Confidence Interval|Mean
2724873|NCT01061775|Primary|Waist to Height Ratio (WHtR)|Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks|24 weeks|All analyses were performed using SPSS (version 20.0.0, SPSS Inc, Chicago, IL).|||percentage||Standard Deviation|Mean
2724874|NCT01061775|Primary|BMI Change|BMI was collected at baseline and 24 weeks|24 weeks|The effects of exenatide on BMI were analyzed using a paired t-test comparing BMI at baseline with BMI after six months of treatment with each patient serving as his or her own control.|||kg/m^2||95% Confidence Interval|Mean
2724875|NCT01061736|Secondary|Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52|Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.|Baseline up to Week 52|ITT population which included all participants randomized after dose selection (cohort 2).|||Percentage of participants|||Number
2724876|NCT01061736|Primary|Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52|The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.|Baseline, Week 52|Cohort 2 ITT population and included participants with available data of mTSS at baseline and on or before Week 52.|||units on a scale||Standard Deviation|Mean
2724877|NCT01061736|Primary|Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16|HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.|Baseline, Week 16|Cohort 2 ITT population only and included participants with available data of HAQ-DI at baseline and on or before Week 16.|||units on a scale||Standard Deviation|Mean
2724878|NCT01061736|Primary|Part B: Percentage of Participants Achieving ACR20 Response at Week 24|ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.|Baseline to Week 24|ITT population which included all participants randomized after dose selection (cohort 2).|||Percentage of participants|||Number
2724879|NCT01061736|Primary|Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).|Baseline to Week 12|Part A Intent-to-treat (ITT) population defined as all randomized participants.|||Percentage of participants|||Number
2724928|NCT01061177|Secondary|Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months|PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.|12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724880|NCT01061723|Secondary|Change From Baseline in ASAS Individual Components at Week 12|ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASAS assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
2724881|NCT01061723|Secondary|Change From Baseline in Hs-CRP at Week 12|Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with Hs-CRP assessment at specified time-points.|||mg/dL||Standard Deviation|Mean
2724882|NCT01061723|Secondary|Change From Baseline in Swollen Joint Index at Week 12|44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with swollen joint count assessment at specified time-points.|||Joints||Standard Deviation|Mean
2724883|NCT01061723|Secondary|Change From Baseline in Chest Expansion at Week 12|The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with chest expansion assessment at specified time-points.|||cm||Standard Deviation|Mean
2724884|NCT01061723|Secondary|Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12|ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.|||percentage of participants|||Number
2724885|NCT01061723|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12|ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with ASspiMRI-a assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
2724886|NCT01061723|Secondary|Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12|The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober's test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed=participants with BASMI score assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
2724887|NCT01061723|Secondary|Change From Baseline in BASDAI Score at Week 12|BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with BASDAI score assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
2724888|NCT01061723|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] - 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASDAS score assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
2724889|NCT01061723|Secondary|Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12|Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.|||percentage of participants|||Number
2726570|NCT01047839|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and upt to Month 7|||||||
2724890|NCT01061723|Secondary|Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12|Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.|||percentage of participants|||Number
2724891|NCT01061723|Primary|Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12|Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using LOCF.|||percentage of participants|||Number
2724892|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Proportion of Responders||24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.||||||
2724893|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)||24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.||||||
2724894|NCT01061710|Secondary|Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert|An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.|||Participants|||Number
2724895|NCT01061710|Primary|Number of Responders to Varenicline Treatment|Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.|24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.|||Participants|||Number
2724896|NCT01061710|Primary|Number of Participants With Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.|||Participants|||Number
2724897|NCT01061671|Secondary|Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)||up to 37 months|Analysis excludes participants without any follow-up data.|||events per patient year||95% Confidence Interval|Mean
2724898|NCT01061671|Secondary|Change in FEV1 (% Pred) From Baseline to Last Measure||Baseline, last measure at up to 37 months|Analysis excludes participants without any follow-up data.|||percent predicted||90% Confidence Interval|Median
2724899|NCT01061671|Secondary|Time to First COPD Exacerbation||up to 37 months|Analysis excludes participants without any follow-up data.|||Days to the first exacerbation||95% Confidence Interval|Median
2724900|NCT01061671|Primary|Rates of COPD Exacerbations||up to 37 months|Analysis excludes participants without any follow-up data.|||exacerbations/person-year||Standard Deviation|Mean
2724901|NCT01061606|Secondary|Time to Progression||Time to progression is defined as the time from registration to disease progression.|The study concluded terminated early and patients were not followed.||||||
2724902|NCT01061606|Secondary|Time to Treatment Failure|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|From study registration to the date patients end treatment, assessed up to 3 years|The study concluded terminated early and patients were not followed.||||||
2724903|NCT01061606|Secondary|Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient's Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented|Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years|The study concluded terminated early and patients were not followed.||||||
2724904|NCT01061606|Secondary|Overall Survival|Time to event distributions will be estimated using the Kaplan-Meier method.|From registration to death, assessed up to 3 years|The study concluded terminated early and patients were not followed.||||||
2724905|NCT01061606|Primary|Progression Free Survival|The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.|6 months from registration|The study concluded terminated early and patients were not followed.||||||
2724906|NCT01061606|Primary|Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST||Up to 3 years||||participants|||Number
2724907|NCT01061567|Secondary|Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score|The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.|||units on a scale||Standard Deviation|Mean
2726571|NCT01047839|Secondary|Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination||7 days|||||||
2724908|NCT01061567|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction|The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in VAS at baseline and at visit 3.|||units on a scale||Standard Deviation|Mean
2724909|NCT01061567|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder Rate|The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.|Baseline and the end of study (up to 16 weeks)|Patients from FAS|||percentage of participants|||Number
2724910|NCT01061567|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score|Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.|Baseline and the end of study (up to 16 weeks)|Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.|||units on a scale||Standard Deviation|Mean
2724911|NCT01061567|Primary|Proportion of Patients With Withdrawals Due to Adverse Events.|Patients who discontinued treatment due to adverse events including deaths.|16 weeks|Patients from the Treated Set (TS).|||proportion of participants|||Number
2724912|NCT01061567|Primary|Incidence of Adverse Events|The number of patients with any adverse events (AEs), patients with drug-related AEs.|From the treatment initiation to the end of study, on average 92.9 days|Patients from the Treated Set (TS).|||participants|||Number
2724913|NCT01061528|Primary|Number of Participants With Biochemically Verified Smoking Abstinence|"Carbon monoxide of expired air~Salivary cotinine level of saliva"|Six months||||Participants|||Count of Participants
2724914|NCT01061476|Primary|Change in AHI|The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).|Comparisons were made between the 2 nights|Although all participants went through the sleep studies, there was insufficient data in 1 subject to assess sleep apnea severity and was therefore excluded from analysis.|||events/h||Standard Deviation|Mean
2724915|NCT01061385|Secondary|Percentage of Subjects With >=25% Excess Weight Loss (EWL)|a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months|12 months||||percentage of subjects|||Number
2724916|NCT01061385|Primary|%Excess Weight Loss|the difference between the %EWL between treatment and control groups must be clinically significant|36 Weeks||||percent excess weight loss||Standard Deviation|Mean
2724917|NCT01061359|Secondary|Time to Recurrence (DFI)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Median time to recurrence was not reached.|||months||Full Range|Median
2724918|NCT01061359|Secondary|Time to Progression (TTP)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|16.3% of patients had experienced disease progression by the end of the study. As this is less than 50% the median time to progression is not defined.|||months||Full Range|Median
2724919|NCT01061359|Primary|Percentage of Participants With Disease Free Survival (DFS)|Percentage of participants with DFS who completed 5 year follow-up visit.|3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Intent to treat (ITT)|||Percentage of participants|||Number
2724920|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTE4|Concentrations of LTE4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.|||pg/mL||Standard Deviation|Geometric Mean
2724921|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTD4|Concentrations of LTD4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.|||pg/mL||Standard Deviation|Geometric Mean
2724922|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTC4|Concentrations of LTC4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.|||pg/mL||Standard Deviation|Geometric Mean
2724923|NCT01061333|Secondary|Allergen-induced Changes in Urinary Leukotriene (LT) E4|Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed|||Fold change over baseline||Standard Deviation|Geometric Mean
2724924|NCT01061333|Secondary|Allergen-induced Changes in Urinary 9P|Fold change over baseline in Urinary 9P at 2 hours post allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed|||Fold change over baseline||Standard Deviation|Geometric Mean
2724925|NCT01061333|Primary|Change in Plasma 9P at 20 Minutes|Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge|Pre-allergen challenge and 20 minutes post allergen challenge||||Fold change over baseline||Standard Deviation|Geometric Mean
2724926|NCT01061333|Primary|Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes|Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge|Pre-allergen challenge and 5 minutes post allergen challenge||||Fold change over baseline||Standard Deviation|Geometric Mean
2724927|NCT01061333|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Maximal percent drop in FEV1 at 20 minutes post allergen challenge|Pre-allergen challenge and 20 minutes after allergen challenge||||Percentage drop in FEV1||Standard Deviation|Least Squares Mean
2724929|NCT01061177|Secondary|Rate of Molecular Response (MR4^5) by 18 Months|"MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).~BCR = Breakpoint Cluster Region gene/BCR gene product~BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase"|by 18 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.|||Percentage of participants|||Number
2724930|NCT01061177|Secondary|Rate of Molecular Response (MR4^0) by 18 Months|"MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.~BCR = Breakpoint Cluster Region gene/BCR gene product~BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase"|by 18 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.|||Percentage of participants|||Number
2724931|NCT01061177|Secondary|Percentage of Participants With Overall Survival at 12 and 24 Months|OS was defined as the time between the date of Day 1 (first treatment) and the date of death from any cause. Deaths which occurred after the 24-month time window and which were occasionally reported by some Investigators were excluded from the analysis. This is in agreement with the protocol stating that patients were to be followed for survival and progression to AP/BC up to 24 months after the participants treatment start.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724932|NCT01061177|Secondary|Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months|CHR was defined as all of the following present for ≥ 4 weeks in the peripheral blood: WBC count < 10 x 109/L, Platelet count < 450 x 109/L, No circulating peripheral blood blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood, The presence of < 5% basophils, No evidence of disease-related symptoms and extramedullary disease, including spleen and liver. Loss of CHR was defined as the appearance of any of the following after having achieved a CHR confirmed by a second determination ≥ 4 weeks later (unless associated with progression to AP/BC or death, which was considered to be a confirmed loss of CHR event on its own): WBC count that increased to > 20.0 x 109/L, Platelet count that increased to ≥ 600 x 109/L, Any palpable spleen, defined as size of spleen below costal margin > 5 cm, Appearance of > 5% myelocytes plus metamyelocytes, or any promyelocytes or blasts in the peripheral blood.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of prticipants|||Number
2724933|NCT01061177|Secondary|Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months|MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).|12 and 24 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.|||Percentage of participants|||Number
2724934|NCT01061177|Secondary|Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months|MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.|12 and 24 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.|||Percentage of participants|||Number
2724935|NCT01061177|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months|PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724936|NCT01061177|Secondary|Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months|EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (i.e. 91 + 15 days).|at 12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724937|NCT01061177|Secondary|Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months|"The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.~BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy."|at 12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724938|NCT01061177|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months|Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.|12 and 24 months|The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.|||Percentage of participants|||Number
2725004|NCT01060540|Secondary|Insulin Resistance (HOMA2-IR)|"Calculated using the updated homeostasis model assessment (HOMA) calculator at http://www.dtu.ox.ac.uk/homacalculator/~Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance."|3 months||||units on a scale||Standard Deviation|Mean
2725005|NCT01060540|Primary|Weight|weight 3 months post-enrollment|3 months||||kg||Standard Deviation|Mean
2724939|NCT01061177|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months|CCyR parameters were defined as 0% Philadelphia positive (Ph+) metaphases. Loss of CCyR was defined as a patient exceeding the CCyR criteria (ie, > 0% Ph+ metaphases) at a subsequent visit after the patient had achieved CCyR.|12 and 24 months|The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.|||Percentage of participants|||Number
2724940|NCT01061177|Secondary|Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months|"MMR was defined as BCR-ABL ratio (IS) ≤ 0.1% in a peripheral blood sample. BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR (breakpoint cluster region) gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins."|12 months, 24 months|Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.|||Percentage of participants|||Number
2724941|NCT01061177|Secondary|Rate of Event Free Survival at 12 and 24 Months|EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (ie, 91 + 15 days), Not achieving CCyR up to 18 months (ie, 548 + 15 days), whichever is earlier.|at 12 and 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724942|NCT01061177|Secondary|Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months|"The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.~BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy."|at 12 and 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
2724943|NCT01061177|Primary|Percentage of Participants With Molecular Response (MR4^0) at 18 Months|MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.|at 18 months|Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.|||Percentage of Participants|||Number
2724944|NCT01061151|Secondary|Maternal Health Component: Cost-effectiveness|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|From study entry until July 7, 2015.|||||||
2724945|NCT01061151|Secondary|Maternal Health Component: Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
2724946|NCT01061151|Secondary|Maternal Health Component: Quality of Life|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|From study entry until July 7, 2015.|||||||
2724947|NCT01061151|Secondary|Maternal Health Component: Self-reported Adherence|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|From study entry until July 7, 2015.|||||||
2724948|NCT01061151|Secondary|Maternal Health Component: Viral Resistance|This secondary outcome required additional funding for laboratory testing which was not awarded because this outcome was deemed no longer scientifically important, so this outcome is not reported.|From study entry until July 7, 2015.|||||||
2724949|NCT01061151|Secondary|Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results|The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724950|NCT01061151|Secondary|Maternal Health Component: Incidence of Tuberculosis|Incidence of tuberculosis.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724951|NCT01061151|Secondary|Maternal Health Component: Composite Endpoint of Any Condition Outlined in Appendix IV of the Protocol or Death|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
2724952|NCT01061151|Secondary|Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events|"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group."|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724953|NCT01061151|Secondary|Maternal Health Component: Incidence of HIV/AIDS-related Event or Death|"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group."|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724954|NCT01061151|Secondary|Maternal Health Component: Other Targeted Medical Conditions|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
2724955|NCT01061151|Secondary|Maternal Health Component: Number of Cardiovascular or Other Metabolic Events|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
2724956|NCT01061151|Secondary|Maternal Health Component: Incidence of HIV/AIDS-related Events|"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group."|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724957|NCT01061151|Secondary|Maternal Health Component: Composite Endpoint of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
2724958|NCT01061151|Secondary|Maternal Health Component: Incidence of AIDS-defining Illness|"AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group."|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724959|NCT01061151|Secondary|Maternal Health Component: Incidence of Death||From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
2724960|NCT01061151|Secondary|Postpartum Component: Functional Maternal Antibody and HIV-envelope Binding Responses in Breast Milk and Plasma, Until Cessation of Breastfeeding or 18 Months Postpartum, Whichever Comes First|This secondary outcome required additional funding for laboratory testing. Results will be reported to ct.gov when available.|Measured through the time of cessation of breastfeeding or 18 months postpartum, whichever comes first|||||||
2724961|NCT01061151|Secondary|Postpartum Component: Pharmacokinetic Parameters of ARV Drugs Measured in Maternal Plasma, Hair, Breast Milk, and Infant Blood (Plasma or Dried Blood Spot) Samples Collected at Birth; Weeks 1, 6, 14, and 26; and Subsequent Visits During Breastfeeding|This secondary outcome required additional funding for laboratory testing. Results will be reported to ct.gov when available.|Measured through the last study visit during breastfeeding, or 18 months postpartum, whichever comes first|||||||
2724962|NCT01061151|Secondary|Postpartum Component: Cost-effectiveness and Feasibility of the Study ARV Prophylaxis Regimens|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured at the end of the 5-year study period|||||||
2724963|NCT01061151|Secondary|Postpartum Component: Rates and Patterns of Maternal and Infant Resistance to the Maternal and Infant ARV Regimens|This secondary outcome required additional funding for laboratory testing which was not awarded because this outcome was deemed no longer scientifically important, so this outcome is not reported.|Measured at the end of the 5-year study period|||||||
2724964|NCT01061151|Secondary|Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured through complete cessation of breastfeeding or 18 months of age, whichever comes first|||||||
2724965|NCT01061151|Secondary|Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery|Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair)|Measured at 12 and 24 months post-delivery|All live-born infants were included in the analyses. 4 infants with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.|||Probability||95% Confidence Interval|Number
2725065|NCT01060020|Secondary|Global Longitudinal Strain|Global longitudinal strain was measured at baseline and 60 minutes after drug administration.|Baseline and 60 minutes after drug administered||||percent||Standard Deviation|Mean
2724966|NCT01061151|Secondary|Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery|Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.|Measured through 24 months post-delivery|All M-I pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 3 M-I pairs with no post-randomization data were included and censored at the date of randomization. Analyses were intent to treat.|||Probability||95% Confidence Interval|Number
2724967|NCT01061151|Secondary|Antepartum Component: Antepartum Change in HBV DNA Viral Load Between Week 8 and Baseline Levels (Using Log HBV DNA) Among Women With Detectable HBV DNA Viral Loads at Baseline and Other HBV Outcome Measures|This secondary outcome required additional funding for laboratory testing. Results will be reported to ct.gov when available.|Measured at Week 8|||||||
2724968|NCT01061151|Secondary|Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery|Analysis used the principle of intent to treat.|Measured at the time of delivery|Analysis includes only mothers with HIV RNA data at delivery. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
2724969|NCT01061151|Secondary|Antepartum Component: Cost Effectiveness and Feasibility of the Trial ARV Regimens|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured at the end of the 5-year study period|||||||
2724970|NCT01061151|Secondary|Antepartum Component: Maternal and Infant Viral Resistance to the Maternal and Infant ARV Strategies|This secondary outcome required additional funding for laboratory testing which was not awarded because this outcome was deemed no longer scientifically important, so this outcome is not reported.|Measured at the end of the 5-year study period|||||||
2724971|NCT01061151|Secondary|Antepartum Component: Adherence to the Maternal Antiretroviral (ARV) Regimen, as Measured by Maternal Report|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured through the Week 1 postpartum study visit|||||||
2724972|NCT01061151|Secondary|Antepartum Component: Overall and HIV-free Infant Survival Through 24 Months of Age (in Conjunction With Infants in the Postpartum Component)|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured through 24 months of age|||||||
2724973|NCT01061151|Secondary|Antepartum Component: Number of Infant HIV Infections|Detected by HIV NAT positivity|Measured at the birth (<= 3 days postpartum) visit|Analysis is among the live births with HIV test results summarized in the maternal-infant set (the worst outcome summarized for multiple births to the same mother). Analysis used the principle of intent to treat.|||Participants|||Count of Participants
2724974|NCT01061151|Primary|Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death|AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years|||Number
2724975|NCT01061151|Primary|Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events|These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).|Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first|All mothers were included in the analyses. 15 mothers with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.|||New cases per 100 person-years|||Number
2724976|NCT01061151|Primary|Postpartum Component: Incidence of Confirmed Infant HIV Infection|Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.|Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first|All Mother-Infant (M-I) pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 35 M-I pairs with no post-randomization HIV test results were included and censored at the date of randomization in the analyses. Analyses were intent to treat.|||New cases per 100 person-years|||Number
2724977|NCT01061151|Primary|Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)|Composite outcome|Measured at birth|Includes mothers with confirmed infant birth outcome as live birth, stillbirth, or spontaneous abortion and outcome assessments. Multiple gestation pregnancies (twins and triplets) were summarized at the unique mother level. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
2724978|NCT01061151|Primary|Antepartum Component: Number of Mothers With Obstetrical Complications||Measured through the Week 1 postpartum study visit|Mothers who do not have any obstetrical complications information available after study entry are not included. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
2724979|NCT01061151|Primary|Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events|These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).|Measured through the Week 1 postpartum study visit|Mothers with no safety data available after baseline were not included. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
2726572|NCT01047839|Secondary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination||up to Month 7|||||||
2724980|NCT01061151|Primary|Antepartum Component: Number of Confirmed Infant HIV Infections|Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point|Measured at birth or Week 1 study visit|Analysis includes data from periods 1 and 2. Analysis is among the live births with HIV test results summarized for the maternal-infant set (the worst outcome summarized for cases of multiple births). Analysis used the principle of intent to treat.|||Participants|||Count of Participants
2724981|NCT01061034|Secondary|Platelet Function Tests|"Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.~the results reflects the percent of active platelets."|on day 0 as a baseline and on day 7 and 21 of the study.||||percent||Standard Deviation|Mean
2724982|NCT01061034|Primary|Aspirin Level in Blood (Area Under the Curve)|"Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.~The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin."|on day 7,on day 21|9 volunteers completed the study, one volunteer was excluded from pharmacokinetics, because serum salicylic acid concentration was not at the baseline (non-detectable) in the 0-hour sample.|||mg*hour/mL||Standard Deviation|Mean
2724983|NCT01061008|Secondary|Forearm Muscle Cross Sectional Area||3 months|||||||
2724984|NCT01061008|Secondary|Handgrip Endurance||3 months|||||||
2724985|NCT01061008|Secondary|Maximum Handgrip Strength||3 months|||||||
2724986|NCT01061008|Primary|Venous Diameter.|Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese & Nonnast-Daniel, 2004).|3 months||||mm||Standard Deviation|Mean
2724987|NCT01060670|Secondary|Change in Short Form Health Survey (SF-36) Quality of Life Metrics|Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.|Baseline and 16 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2724988|NCT01060670|Secondary|Incidence of Ulcer Recurrence|Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.|12 weeks|ITT Population complete wound healed|||participants|||Number
2724989|NCT01060670|Secondary|Rate of Wound Closure|Rate of wound closure as assessed by computerized planimetry|16 weeks|ITT Population|||percentage wound closure/week||Standard Deviation|Mean
2724990|NCT01060670|Secondary|Time to Complete Wound Closure|Time to complete wound closure, as assessed by computerized planimetry.|16 weeks|ITT population complete wound healed with analyzable data|||days||Full Range|Median
2724991|NCT01060670|Secondary|Time to Complete Wound Closure|Measures the time to complete wound closure as assessed by the Investigator.|16 weeks|ITT Population complete wound healed with analyzable data|||days||Standard Deviation|Mean
2724992|NCT01060670|Secondary|Incidence of Complete Wound Closure|Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.|16 weeks|ITT Population|||percentage of subjects|||Number
2724993|NCT01060670|Primary|Incidence of Complete Wound Closure|100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.|16 weeks|The results were based on the Investigator assessment and ITT population.|||participants|||Number
2724994|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Small Bands Only)||12m post surgery||||%EWL||Standard Deviation|Mean
2724995|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)||12m post surgery||||%EWL||Standard Deviation|Mean
2724996|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)||4-6 weeks post surgery||||%EWL||Standard Deviation|Mean
2724997|NCT01060592|Secondary|Number of Band Adjustments Required in the First Year After Surgery||12 months||||Number of Adjustments||Standard Deviation|Mean
2724998|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)||4-6 weeks post surgery||||%EWL||Standard Deviation|Mean
2724999|NCT01060553|Secondary|Pittsburgh Sleep Index|subscales range from 0 to 3 with higher being worse.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis|||units on a scale||Standard Deviation|Mean
2725000|NCT01060553|Primary|SF-36|global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.|||units on a scale||Standard Deviation|Mean
2725001|NCT01060540|Secondary|Moderate Intensity Physical Activity|self-report based on the long version of the International Physical Activity Questionnaire. Moderate physical activity was queried in the domains of work (e.g., carrying light loads), transportation (e.g., bicycling), domestic chores and gardening (e.g., sweeping, raking), and leisure-time (e.g., bicycling, swimming).|3 months||||minutes per week||Standard Deviation|Mean
2725002|NCT01060540|Secondary|Daily Caloric Intake|Estimated daily caloric intake based on self-reported frequency and amount of intake of specific foods over the past 3 months as assessed by the Block Brief Food Frequency Questionnaire|3 months||||kcal||Standard Deviation|Mean
2725003|NCT01060540|Secondary|Perceived Lifetime Risk of Type 2 Diabetes|measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)|3 months||||units on a scale||Standard Deviation|Mean
2725006|NCT01060384|Secondary|Phase I and Phase II: Event Free Survival and Overall Survival|"Event free survival is defined as the time from start of treatment to disease progression or death from any cause. Overall survival (OS) is defined as the time from start of treatment to death from any cause. A response-evaluable subject will be considered anyone who completes at least 2 cycles of therapy with documented response or documented progression of disease after at least one complete cycle of therapy but, prior to 2 complete cycles of therapy.~A response-evaluable subject will be considered anyone who completes at least 2 cycles of therapy with documented response or documented progression of disease after at least one complete cycle of therapy but, prior to 2 complete cycles of therapy. A non-evaluable subject will be one who receives less than one complete cycle of therapy (ie. 4 infusions of ofatumumab and 21 days of lenalidomide). A non-evaluable subject will also be one that has no documented response prior to treatment withdrawal."|2 years from start of treatment|Six patients in Phase 1 were treated at the MTD and 34 patients enrolled in Phase II were eligible for evaluation. Data was analyzed for all patients treated at the MTD (n=40).|||percent of participants|||Number
2725007|NCT01060384|Primary|Phase I: Maximum Tolerated Dose (MTD) of Lenalidomide|The maximum tolerated dose (MTD) will be defined as the next lowest dose cohort below where ≥ 2/3 or ≥ 3/6 patients experience dose limiting toxicities in cycle 1.|7 months|Ten patients were enrolled in Phase 1. One patient was inevaluable, thus 9 patients are evaluable for outcome. Patients will be evaluable for Dose Limiting Toxicity (DLT) if they receive at least 75% of the planned doses of study drugs or they experience DLT in cycle 1 or and have sufficient followup data to determine whether DLT occurred.|||milligrams|||Number
2725008|NCT01060345|Secondary|Safety of Green Tea Ingestion|Number of patients with adverse event.|6 weeks||||Participants|||Count of Participants
2725009|NCT01060345|Secondary|Change in Serum Levels of IGF-1||Prior to study start and after 4-6 weeks of treatment|0 analyzed, data not collected as the study stopped early due to lack of drug supply||||||
2725010|NCT01060345|Secondary|Change in Percent Staining of VEGF in Breast Tissue||Prior to study start and after 4-6 weeks of treatment|0 analyzed, data not collected as the study stopped early due to lack of drug supply||||||
2725011|NCT01060345|Secondary|Change in Percent Staining of CD31 in Breast Tissue||Prior to study start and 4-6 weeks after treatment|0 analyzed, data not collected as the study stopped early due to lack of drug supply||||||
2725012|NCT01060345|Secondary|Change in Percent Staining of CD68 in Breast Tissue||Prior to study start and 4-6 weeks after treatment|0 analyzed, data not collected as the study stopped early due to lack of drug supply||||||
2725013|NCT01060345|Secondary|Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.||Prior to study start and 4-6 weeks after treatment|0 analyzed, data not collected as the study stopped early due to lack of drug supply||||||
2725014|NCT01060345|Primary|Percent Change in K167 Staining||Prior to starting study and after 4-6 weeks of treatment|0 analyzed, data not collected as the study stopped early due to lack of drug supply||||||
2725015|NCT01060150|Secondary|Stroop Test Score for Ratio Interference|Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2725016|NCT01060150|Secondary|Stroop Test Result for False Reaction|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Errors||Standard Deviation|Mean
2725017|NCT01060150|Secondary|Stroop Test Result for Reaction Time|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Seconds||Standard Deviation|Mean
2725018|NCT01060150|Secondary|Controlled Oral Words Association Test (COWAT) Score|This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Words||Standard Deviation|Mean
2725066|NCT01060020|Secondary|Load Independent Index of Diastolic Filling.|Measurements of the load independent index of diastolic filling were made with the parameterized diastolic filling formalism as previously described and validated with the use of transmitral Doppler E waves recorded during different respiratory states (regular breathing and held expiration and inspiration).|Baseline and 60 minutes after drug administered||||unitless||Standard Deviation|Mean
2725019|NCT01060150|Secondary|Finger Window (FW) Test Score|In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2725020|NCT01060150|Secondary|Digit Span Test Score|Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2725021|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on scale||Standard Deviation|Mean
2725022|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Errors||Standard Deviation|Mean
2725023|NCT01060150|Primary|Learning Skill Test (LST) Total Score|The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||T-score||Standard Deviation|Mean
2725024|NCT01060150|Primary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2725025|NCT01060150|Primary|Clinical Global Impression - Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.|||Units on a scale||Standard Deviation|Mean
2725026|NCT01060150|Primary|Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score|The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.|Week 12|Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2725067|NCT01060020|Secondary|Percent Change in Cardiac Index.|Cardiac index is cardiac output divided by body surface area.|Baseline and 60 minutes after drug administered||||percent change||Inter-Quartile Range|Median
2725027|NCT01060124|Other Pre-specified|Number of Participants With Investigator's Overall Evaluation on the Pain Treatment|Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.|Day 29|Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2725028|NCT01060124|Other Pre-specified|Initial and End Point Dose of TTS-Fentanyl D-trans|Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.|Day 1 and Day 29|Safety population included all participants who were administered the TTS-fentanyl D-trans at least once.|||microgram per hour (mcg/hr)||Standard Deviation|Mean
2725029|NCT01060124|Other Pre-specified|Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment|Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.|Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2725030|NCT01060124|Secondary|Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans|Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.|Day 1 and Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
2725031|NCT01060124|Primary|Percentage of Participants Satisfied With Pain Treatment|Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.|Day 29|Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial.|||percentage of participants||95% Confidence Interval|Number
2725032|NCT01060111|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6|"VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating no headache and the other end with 10 points indicating unimaginably strong headache. It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6."|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a Scale||Standard Deviation|Mean
2725033|NCT01060111|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6|MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2725034|NCT01060111|Secondary|Change From Baseline in Migraine Frequency at Week 6|The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Migraine episodes/Week||Standard Deviation|Mean
2725035|NCT01060111|Primary|Percentage Decrease in Migraine Episodes|Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS).|Maintenance period (Weeks 7 to 10)|The intent-to-treat (ITT) population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N' signifies participants who were evaluated for this outcome measure.|||Percentage decrease in migraine episodes||Standard Deviation|Mean
2725036|NCT01060098|Primary|Measurement of Effector T Helper Type 17 Cells in Peripheral Blood|The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)).|Week 0, Week 12|Patients with RA were studied at protocol visits during the initial 12 weeks of anti-TNF treatment|||spSFC/10^6||Standard Error|Mean
2725037|NCT01060072|Secondary|Resolution of Anterior Chamber Flare|Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)|||participants|||Number
2725038|NCT01060072|Secondary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain|Visits 4-7 (Postoperative days 3-18)|Intention to treat population (ITT)|||participants|||Number
2725039|NCT01060072|Secondary|Resolution of Anterior Chamber Cells|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)|||participants|||Number
2725040|NCT01060072|Primary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population|||participants|||Number
2725041|NCT01060072|Primary|Resolution of Anterior Chamber Cells.|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population|||participants|||Number
2725068|NCT01060020|Secondary|Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.||Baseline and 60 minutes after drug administered||||percent change||Inter-Quartile Range|Median
2725069|NCT01060020|Primary|Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.||Baseline and 60 minutes after drug administered||||percent change||Inter-Quartile Range|Median
2725042|NCT01060059|Secondary|Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline|Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.|||mg/dL||Standard Deviation|Mean
2725043|NCT01060059|Secondary|Factor of Greater Height Associated With Treatment Choice at Baseline|Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not provide height data so n=437."|||cm||Standard Deviation|Mean
2725044|NCT01060059|Secondary|Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2.|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not have data in this arm so n=437."|||kg/m^2||Standard Deviation|Mean
2725045|NCT01060059|Secondary|Factor of Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.|||years||Standard Deviation|Mean
2725046|NCT01060059|Secondary|Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline|The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.|||years||Standard Deviation|Mean
2725047|NCT01060059|Secondary|Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline|Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443."|||Percentage of normal||Standard Deviation|Mean
2725048|NCT01060059|Secondary|Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline|Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.|baseline|All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.|||participants|||Number
2725049|NCT01060059|Secondary|Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12|"Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.~All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected."|Baseline to Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
2725050|NCT01060059|Secondary|Changes in Systolic Blood Pressure Between Baseline and Month 12|Changes in Systolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mmHg||Standard Deviation|Mean
2725096|NCT01059903|Secondary|Rate Constant of Elimination (λz) of Unconjugated Rotigotine|The λz of unconjugated rotigotine is the rate constant of elimination.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||1/ h||Standard Deviation|Mean
2725051|NCT01060059|Secondary|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mmHg||Standard Deviation|Mean
2725052|NCT01060059|Secondary|Changes in Fasting Triglycerides Between Baseline and Month 12|Changes in Fasting Triglycerides Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
2725053|NCT01060059|Secondary|Changes in Fasting LDL Between Baseline and Month 12|Changes in Fasting LDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
2725054|NCT01060059|Secondary|Changes in Fasting HDL Between Baseline and Month 12|Changes in Fasting HDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
2725055|NCT01060059|Secondary|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
2725056|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
2725057|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
2725058|NCT01060059|Secondary|Changes in Weight From Baseline to Month 12|Changes in Weight From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||kg||Standard Deviation|Mean
2725059|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
2725060|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
2725061|NCT01060059|Secondary|Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12|Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
2725062|NCT01060059|Secondary|Changes in Fasting Blood Glucose From Baseline to Month 12|Changes in Fasting Blood Glucose From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."|||mg/dL||Standard Deviation|Mean
2725063|NCT01060059|Secondary|Changes in HbA1c From Baseline to Month 12|Changes in HbA1c from Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."|||percent||Standard Deviation|Mean
2725064|NCT01060059|Primary|Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.|Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."|||percentage of patients||95% Confidence Interval|Number
2725070|NCT01060007|Secondary|Determine Quality of Anorectal Function|"Anorectal function was measured by the participant's response to the FACT-C questionnaire question I have control of my bowels. The answers ranged from 0=not at all to 4=very much."|Up to 1 year|Participants who had an ostomy were not included in this outcome measure. Participants who did not complete FACT-C questionnaire at a specific timepoint were not included in that timepoint.|||Participants|||Count of Participants
2725071|NCT01060007|Secondary|Freedom From Disease Relapse|Kaplan-Meier projections.|30 months|These include all cMO evaluable cases only.|||percentage of participants||95% Confidence Interval|Number
2725072|NCT01060007|Secondary|Rate of Locoregional Control||1 year||||percentage of participants|||Number
2725073|NCT01060007|Secondary|Rate of Overall Control||1 year||||percentage of participants|||Number
2725074|NCT01060007|Secondary|Local Control|"Kaplan-Meier projections~Local control = control of primary tumor"|30 months||||percentage of participants||95% Confidence Interval|Number
2725075|NCT01060007|Secondary|Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity||1 year (completion of all treatment)||||participants|||Number
2725076|NCT01060007|Secondary|Incidence of Any Late Grade 3 or Higher Morbidity||Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.|||participants|||Number
2725077|NCT01060007|Primary|Preoperative Gastrointestinal Morbidity|As measured by participants who experience grade 3 or higher gastrointestinal morbidity|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.|||participants|||Number
2725078|NCT01060007|Primary|Rate of T Stage Downstaging|T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)||||percentage of participants|||Number
2725079|NCT01059994|Secondary|Protein Synthesis Rate After 1 Week of Sildenafil or Placebo|Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time) after 1 week of either Placebo or Sildenafil (25 mg/day). Example: if FSR = 0.06 hr-1 it means that 6% of proteins in a given sample were synthesized in the last hour or proteins is synthesized at 6% per hour. A higher rate means that more synthesis is occurring.|1 week||||fraction of proteins synthesized/hr||Standard Deviation|Mean
2725080|NCT01059994|Primary|Change in Muscle Fatigue After 1 Week of Placebo or Sildenafil|"Muscle fatigue was tested before and after 1 week of placebo/sildenafil (25mg/day) treatment.~Subjects were asked to perform maximum effort isokinetic knee extensions until force production reached 50% of their MVC (maximum voluntary contraction). Data was collected as number of successful repetitions completed between start and 50% MVC.~Data is presented as percent change in repetitions (1 week of treatment / baseline)."|baseline to 1 week||||percent change of successful repetitions||Standard Deviation|Mean
2725081|NCT01059929|Secondary|Number of Adverse Medication Effects||duration of infusion of study medication up to 28 days||||number of events|||Number
2725082|NCT01059929|Secondary|Number of Patients Completing Activities of Daily Living|activities of daily living: eating, bathing, dressing, grooming, toileting|daily through day 28||||Participants|||Count of Participants
2725083|NCT01059929|Secondary|Days in Hospital||60 days from enrollment||||days||Inter-Quartile Range|Median
2725084|NCT01059929|Secondary|Number of Patients Requiring Midazolam||during infusion of study medication through day 28||||Participants|||Count of Participants
2725085|NCT01059929|Secondary|Number of Patients Requiring Fentanyl||during infusion of study medication up to day 28||||Participants|||Count of Participants
2725086|NCT01059929|Secondary|Number of Participants With ICU Complications||daily through day 28||||Participants|||Count of Participants
2725087|NCT01059929|Secondary|Mortality||28 days from enrollment||||Participants|||Count of Participants
2725088|NCT01059929|Secondary|Days in ICU||60 days from enollment||||days||Inter-Quartile Range|Median
2725089|NCT01059929|Secondary|Days on Ventilator||60 days from enrollment||||days||Inter-Quartile Range|Median
2725090|NCT01059929|Secondary|Number of Patients Completing Mobility Milestones|Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently|Daily through day 28||||Participants|||Count of Participants
2725091|NCT01059929|Secondary|Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score|Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided.|Daily up to day 28||||score on a scale||Inter-Quartile Range|Median
2725092|NCT01059929|Primary|Proportion of Days With Delirium|delirium assessment using CAM-ICU|daily up to 28 days|Study terminated early due to inability to maintain study drug supply in investigational pharmacy.|||proportion of days||Inter-Quartile Range|Median
2725093|NCT01059903|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.|24 hours|Pharmacokinetic Set (PKS)|||mg||Standard Deviation|Mean
2725094|NCT01059903|Secondary|Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine|The CL/f of unconjugated rotigotine is the apparent total body clearance.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||L/ h||Standard Deviation|Mean
2725095|NCT01059903|Secondary|Terminal Half-Life (t1/2) of Unconjugated Rotigotine|the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||hours (h)||Standard Deviation|Mean
2725098|NCT01059903|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach maximum plasma concentration after patch application.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||hours (h)||Standard Deviation|Mean
2725099|NCT01059903|Secondary|Cmax, Norm (Body Weight) of Unconjugated Rotigotine|The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*kg||Standard Deviation|Mean
2725100|NCT01059903|Secondary|Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL/ mg||Standard Deviation|Mean
2725101|NCT01059903|Secondary|AUC(0- ∞) Norm (Body Weight)|The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng*h*kg/ mL||Standard Deviation|Mean
2725102|NCT01059903|Secondary|AUC(0- ∞) Norm (Apparent Dose)|The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h/ mg||Standard Deviation|Mean
2725103|NCT01059903|Secondary|AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng*h*kg/ mL||Standard Deviation|Mean
2725104|NCT01059903|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h/ mg||Standard Deviation|Mean
2725105|NCT01059903|Primary|AUC(0- ∞) of Unconjugated Rotigotine|The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h||Standard Deviation|Mean
2725106|NCT01059903|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL||Standard Deviation|Mean
2725107|NCT01059903|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h||Standard Deviation|Mean
2725108|NCT01059877|Primary|Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) Delayed Word Recall.|Delayed Word Recall is a subscale of the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), a measure of cognitive impairment. Higher scores indicate greater impairment. Range: 0-10. Measures were taken within 72 hours of the first day of treatment and within 72 hours following the 28th day of treatment. Outcome measure was calculated by subtracting pretest from post test ADAS-Cog measurements.|Post-tx (total intervention period = 28 days) scores to be compared to baseline scores.||||units on a scale||Full Range|Mean
2725109|NCT01059864|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||units on a scale||Standard Deviation|Mean
2725110|NCT01059864|Secondary|Patient's Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain."|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm||Standard Deviation|Mean
2725111|NCT01059864|Secondary|Physician's Global Assessment (PhysGA) of Arthritis Pain|The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient's global assessment of arthritis. Physician's response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm||Standard Deviation|Mean
2725112|NCT01059864|Secondary|Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm||Standard Deviation|Mean
2725113|NCT01059864|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm/hr||Standard Deviation|Mean
2725114|NCT01059864|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mg/L||Standard Deviation|Mean
2725115|NCT01059864|Secondary|Swollen-Joint Count|Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||swollen joints||Standard Deviation|Mean
2725116|NCT01059864|Secondary|Tender-Joint Count|Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||tender joints||Standard Deviation|Mean
2725117|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||percentage of participants|||Number
2725118|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||percentage of participants|||Number
2725119|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||percentage of participants|||Number
2725120|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) [mm/hr] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) <=3.2 indicated low disease activity, DAS28-4 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725121|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). DAS28-3 (ESR) <=3.2 indicated low disease activity, DAS28-3 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-3(ESR) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.||||||
2725122|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) [mg/L] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 [CRP] <=3.2 indicated low disease activity, DAS28-4 [CRP] >3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-4(CRP) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.||||||
2725211|NCT01059760|Primary|Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed|HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance|Baseline and 3 days||||units on a scale||Standard Deviation|Mean
2725123|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter [mg/L]). DAS28-3 (CRP) less than or equal to (<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (>) 3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||units on a scale||Standard Deviation|Mean
2725124|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||micromole per liter (mcmol/L)||Standard Deviation|Mean
2725125|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2725126|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||nanometer (nm)||Standard Deviation|Mean
2725127|NCT01059864|Secondary|12-Hours Fasting Lipid Profile|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mg/dL||Standard Deviation|Mean
2725128|NCT01059864|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline (Week 6), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2725129|NCT01059864|Primary|Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12||Baseline (Week 6), Week 12|Full analysis set (FAS) included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
2725130|NCT01059851|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
2725131|NCT01059851|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
2725132|NCT01059851|Primary|AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|Per protocol, the decision to conduct Part II of study in moderate/mild renal impairment participants was conditional on results of AUC (0-∞) analysis in severe renal impairment participants (Part I). Based on results of Part I of study, Part II was not conducted and AUC(0-∞) analysis in moderate/mild renal impairment was not done.||||||
2725133|NCT01059851|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|All Treated Participants|||μM•hr||95% Confidence Interval|Geometric Mean
2725134|NCT01059825|Secondary|Number of Participants Who Discontinued Study Medication Due to an AE|An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.|Up to 84 days|All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).|||Participants|||Number
2725212|NCT01059760|Primary|Change From Baseline in Participant Insulin When Fasting and Fed||Baseline and 3 days||||mU/L||Standard Deviation|Mean
2725135|NCT01059825|Secondary|Number of Participants Who Experienced an Advere Event (AE)|An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.|Up to 98 days|All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).|||Participants|||Number
2725136|NCT01059825|Secondary|Percentage of Participants Achieving HbA1C <6.5% at Week 12|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Week 12|Analysis population excludes participants with missing Week 12 HbA1c measurement.|||Percentage of participants|||Number
2725137|NCT01059825|Secondary|Percentage of Participants Achieving HbA1c <7% at Week 12|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Week 12|Analysis population excludes participants with missing Week 12 HbA1c measurement.|||Percentage of participants|||Number
2725138|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 8|The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 8.|||mg/dL||80% Confidence Interval|Least Squares Mean
2725139|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 4.|||mg/dL||80% Confidence Interval|Least Squares Mean
2725140|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2|The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 2.|||mg/dL||80% Confidence Interval|Least Squares Mean
2725141|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 12.|||mg/dL||80% Confidence Interval|Least Squares Mean
2725142|NCT01059825|Secondary|Baseline Fasting Plasma Glucose|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline|All randomized participants.|||mg/dL||Standard Error|Mean
2725143|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 8.|||mmHg||80% Confidence Interval|Least Squares Mean
2725144|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 4|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 4.|||mmHg||80% Confidence Interval|Least Squares Mean
2725145|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 2|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 2.|||mmHg||80% Confidence Interval|Least Squares Mean
2725146|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 12|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 12.|||mmHg||80% Confidence Interval|Least Squares Mean
2725147|NCT01059825|Secondary|Baseline Diastolic Blood Pressure|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.|Baseline|All randomized participants.|||mmHg||Standard Error|Mean
2725148|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 8.|||mmHg||80% Confidence Interval|Least Squares Mean
2725149|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 4|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 4.|||mmHg||80% Confidence Interval|Least Squares Mean
2725150|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 2|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 2.|||mmHg||80% Confidence Interval|Least Squares Mean
2725151|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 12|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 12.|||mmHg||80% Confidence Interval|Least Squares Mean
2725152|NCT01059825|Secondary|Baseline Systolic Blood Pressure|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.|Baseline|All randomized participants.|||mmHg||Standard Error|Mean
2725153|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 8|The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 8.|||Percent change||80% Confidence Interval|Least Squares Mean
2725154|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 4|The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 4.|||Percent change||80% Confidence Interval|Least Squares Mean
2725155|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 2|The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 2.|||Percent change||80% Confidence Interval|Least Squares Mean
2725156|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 12|The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 12.|||Percent change||80% Confidence Interval|Least Squares Mean
2725157|NCT01059825|Secondary|Baseline Body Weight||Baseline|All randomized participants.|||kg||Standard Error|Mean
2725158|NCT01059825|Secondary|Change From Baseline in HbA1c at Week 8|HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 8.|||Percent||80% Confidence Interval|Least Squares Mean
2725159|NCT01059825|Secondary|Change From Baseline in HbA1c at Week 4|HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 4.|||Percent||80% Confidence Interval|Least Squares Mean
2725160|NCT01059825|Secondary|Change From Baseline in HbA1C at Week 2|HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 2.|||Percent||80% Confidence Interval|Least Squares Mean
2725161|NCT01059825|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 12.|||Percent||80% Confidence Interval|Least Squares Mean
2725162|NCT01059825|Primary|Baseline Hemoglobin A1c (HbA1c)|HbA1c is measured as percent.|Baseline|All randomized participants.|||Percent||Standard Error|Mean
2725163|NCT01059812|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||kg||Standard Deviation|Mean
2725164|NCT01059812|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2725165|NCT01059812|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2725213|NCT01059760|Primary|Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed||Baseline and 3 days||||ng/mL||Standard Deviation|Mean
2725166|NCT01059812|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 24 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2725167|NCT01059812|Primary|Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2725168|NCT01059799|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects.The missing data is imputed using last observation carried forward (LOCF). For 25 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2725169|NCT01059799|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2725170|NCT01059799|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2725171|NCT01059799|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2725172|NCT01059773|Secondary|Proportion of Patients Achieving PASI 90 Response|This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.|||Percentage of participants||95% Confidence Interval|Number
2725173|NCT01059773|Secondary|Proportion of Patients Achieving PASI 75 Response|This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.|||Percentage of participants||95% Confidence Interval|Number
2725174|NCT01059773|Secondary|Proportion of Patients Achieving PASI 50 Response|This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.|||Percentage of participants||95% Confidence Interval|Number
2725175|NCT01059773|Secondary|Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline|Change from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 0, 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis|||Units on a scale||Standard Deviation|Mean
2725176|NCT01059773|Secondary|Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)|The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg)|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information|||Number of patients|||Number
2725214|NCT01059760|Primary|Change From Baseline in Participant Glucose When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725177|NCT01059773|Secondary|Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF).|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information|||Number of patients|||Number
2725178|NCT01059773|Primary|Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12||from week 0 to week 12|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.|||participants|||Number
2725179|NCT01059773|Secondary|Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as 'possibly', 'probably', or 'very likely' related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information|||Number of patients|||Number
2725180|NCT01059773|Secondary|Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period|The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE; SAE and Death.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.|||Number of patients|||Number
2725181|NCT01059760|Primary|Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed||Baseline and 3 days||||mg/L||Standard Error|Median
2725182|NCT01059760|Primary|Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed||Baseline and 3 days||||mmHg||Standard Deviation|Mean
2725183|NCT01059760|Primary|Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed||Baseline and 3 days||||mmHg||Standard Deviation|Mean
2725184|NCT01059760|Primary|Change From Baseline in Participant Waist Circumference When Fasting and Fed||Baseline and 3 days||||cm||Standard Deviation|Mean
2725185|NCT01059760|Primary|Change From Baseline in Participant Weight When Fasting and Fed||Baseline and 3 days||||kg||Standard Deviation|Mean
2725186|NCT01059760|Primary|Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed||Baseline and 3 days||||ratio||Standard Deviation|Mean
2725187|NCT01059760|Primary|Change From Baseline in Participant Triglycerides When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725188|NCT01059760|Primary|Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725189|NCT01059760|Primary|Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725190|NCT01059760|Primary|Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725191|NCT01059760|Primary|Change From Baseline in Participant Creatinine When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725192|NCT01059760|Primary|Change From Baseline in Participant Potassium When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
2725193|NCT01059760|Primary|Change From Baseline in Participant Calcium When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725194|NCT01059760|Primary|Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
2725195|NCT01059760|Primary|Change From Baseline in Participant Chloride When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
2725196|NCT01059760|Primary|Change From Baseline in Participant Sodium When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
2725197|NCT01059760|Primary|Change From Baseline in Participant Bicarbonate When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
2725198|NCT01059760|Primary|Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed||Baseline and 3 days||||fL||Standard Deviation|Mean
2725199|NCT01059760|Primary|Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed||Baseline and 3 days||||% of SD of MCV to mean MCV||Standard Deviation|Mean
2725200|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed||Baseline and 3 days||||g/dL||Standard Deviation|Mean
2725201|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed||Baseline and 3 days||||pg||Standard Deviation|Mean
2725202|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed||Baseline and 3 days||||fL||Standard Deviation|Mean
2725203|NCT01059760|Primary|Change From Baseline in Participant Platelet Count When Fasting and Fed||Baseline and 3 days||||cells x 10^3/mL||Standard Deviation|Mean
2725204|NCT01059760|Primary|Change From Baseline in Participant Hematocrit When Fasting and Fed||Baseline and 3 days||||% of red blood cells to whole blood||Standard Deviation|Mean
2725205|NCT01059760|Primary|Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed||Baseline and 3 days||||cells x 10^6/mL||Standard Deviation|Mean
2725206|NCT01059760|Primary|Change From Baseline in Participant Hemoglobin When Fasting and Fed||Baseline and 3 days||||g/dL||Standard Deviation|Mean
2725207|NCT01059760|Primary|Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed||Baseline and 3 days||||cells/mL||Standard Deviation|Mean
2725208|NCT01059760|Primary|Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed||Baseline and 3 days||||pg/mL||Standard Deviation|Mean
2725220|NCT01059643|Other Pre-specified|Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up||End of study treatment up to 30-days post-study treatment discontinuation|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2725221|NCT01059643|Secondary|Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355|Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.|Day 1 and Day 3 of Cycle 1 (21-day cycle)|All enrolled participants who received at least 1 dose of study drug with Ra measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2725222|NCT01059643|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307|Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).|Day 3 of Cycle 1 (21-day cycle)|All enrolled participants who received at least 1 dose of study drug with Cmax measure.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2725223|NCT01059643|Secondary|Change in Tumor Size at Smallest Size (Best Response)|The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.|Baseline until cycle with maximum change from baseline up to 36 weeks|All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response.|||percentage of change||Standard Deviation|Mean
2725224|NCT01059643|Secondary|Tumor Marker Values as Relevant to Specific Tumor Types at Baseline|The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).|Baseline|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2725225|NCT01059643|Secondary|Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.|Baseline until progressive disease up to 36 weeks post-baseline|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2725226|NCT01059643|Secondary|Progression Free Survival (PFS)|PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.|Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment|All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%.|||months||90% Confidence Interval|Median
2725227|NCT01059643|Primary|Percentage of Participants With a Complete Response (CR) or Partial Response (PR)|The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline until progressive disease up to 36 weeks post-baseline|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2725228|NCT01059630|Secondary|Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores|FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0−116). FACT-Lym total score is sum of 42 items (total score ranges from 0−168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).|Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Percentage of participants|||Number
2725229|NCT01059630|Secondary|Time to Deterioration of FACT-Lym TOI|"The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline up to approximately 8.5 years|ITT population.|||Months||95% Confidence Interval|Median
2725230|NCT01059630|Secondary|CFB in FACT-Lym Total Score|"FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0−168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
2725231|NCT01059630|Secondary|CFB in FACT-Lym Trial Outcome Index (TOI)|"TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0−116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
2725232|NCT01059630|Secondary|CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score|"The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||Units on a scale||Standard Deviation|Mean
2725233|NCT01059630|Secondary|CFB in EQ-5D VAS Score During Maintenance Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725234|NCT01059630|Secondary|CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under CFB at Follow-up Month 2 and CFB at Follow-up Month 4 categories."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725267|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
2725235|NCT01059630|Secondary|CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase."|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725236|NCT01059630|Secondary|CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under CFB at Follow-up Month 2 and CFB at Follow-up Month 4 categories."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725237|NCT01059630|Secondary|CFB in FACT-Lym-Lymphoma Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2725238|NCT01059630|Secondary|CFB in FACT-Lym-Functional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725239|NCT01059630|Secondary|CFB in FACT-Lym-Emotional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725240|NCT01059630|Secondary|CFB in FACT-Lym-Social/Family Well-being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725241|NCT01059630|Secondary|Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
2725242|NCT01059630|Secondary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until death (up to 8.5 years overall)|ITT population.|||months||95% Confidence Interval|Median
2725243|NCT01059630|Secondary|Percentage of Participants Who Died||Baseline until death (up to 8.5 years overall)|ITT population.|||percentage of participants|||Number
2725244|NCT01059630|Secondary|Event-free Survival (EFS) as Assessed by IRC|EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.|Baseline until PD or death, whichever occurred first (up to approximately 5 years)|ITT population.|||months||95% Confidence Interval|Median
2725245|NCT01059630|Secondary|Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator|DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)|ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.|||months||95% Confidence Interval|Median
2725246|NCT01059630|Secondary|Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC|DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.|Baseline until PD or death, whichever occurred first (up to approximately 5 years)|ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.|||months||95% Confidence Interval|Median
2725247|NCT01059630|Secondary|Duration of Response (DoR) as Assessed by Investigator|DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)|ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.|||months||95% Confidence Interval|Median
2725268|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.~Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14 and 21 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725248|NCT01059630|Secondary|Duration of Response (DoR) as Assessed by IRC|DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.|Baseline until PD or death, whichever occurred first (up to approximately 5 years)|ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.|||months||95% Confidence Interval|Median
2725249|NCT01059630|Secondary|Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.|||percentage of participants||95% Confidence Interval|Number
2725250|NCT01059630|Secondary|Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.|||percentage of participants||95% Confidence Interval|Number
2725251|NCT01059630|Secondary|Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.|||percentage of participants||95% Confidence Interval|Number
2725252|NCT01059630|Secondary|Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC|BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.|||percentage of participants||95% Confidence Interval|Number
2725269|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|"The Total Vaccinated cohort included all vaccinated subjects for whom data were available~N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here."|||Subjects|||Number
2725253|NCT01059630|Secondary|Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2725254|NCT01059630|Secondary|Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC|BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.|Baseline until PD or death, whichever occurred first (up to approximately 5 years)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2725255|NCT01059630|Secondary|Percentage of Participants With Objective Response as Assessed by Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2725256|NCT01059630|Secondary|Percentage of Participants With Objective Response as Assessed by IRC|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.|Baseline until PD or death, whichever occurred first (up to approximately 5 years)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2725257|NCT01059630|Secondary|PFS as Assessed by Investigator|PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (up to 8.5 years overall)|ITT population.|||months||95% Confidence Interval|Median
2725258|NCT01059630|Secondary|Number of Participants With PD or Death as Assessed by Investigator|PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.|Baseline until PD or death, whichever occurred first (up to 8.5 years overall))|ITT population.|||participants|||Number
2725311|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2725259|NCT01059630|Primary|Progression-Free Survival (PFS) as Assessed by IRC|PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||months||95% Confidence Interval|Median
2725260|NCT01059630|Primary|Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death|PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||participants|||Number
2725261|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
2725262|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725263|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
2725264|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.~Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725265|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
2725266|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725340|NCT01059435|Secondary|Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for sCTX||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*ng/mL||Standard Deviation|Mean
2725270|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|"The Total Vaccinated cohort included all vaccinated subjects for whom data were available.~N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here."|||Subjects|||Number
2725271|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)).~For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated)."|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725272|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2725273|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.|"Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725274|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group|"Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725275|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.|"Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725276|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.|"Solicited local symptoms assessed were pain, redness and swelling and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).~Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725277|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725278|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725279|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.|Up to Day 234|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725280|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).||||Subjects|||Number
2725281|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."|Within 84 days following first dose or 63 days following second dose of vaccine.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725282|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose and the data has been pooled based on the vaccination received at Day 0."|Up to 21-day (Days 0-20) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2725283|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).||||Subjects|||Number
2725284|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).||||Subjects|||Number
2725285|NCT01059617|Secondary|Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens|CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin2, Tumor Necrosis Factor alpha or Interferongamma. The frequency was presented as number of cytokineproducing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.|After the administration of Arepanrix vaccine (Day 125 to 304)|The According-To-Protocol cohort for immunogenicity at Day 304 included all evaluable subjects who had not received a vaccine not specified or forbidden in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken at Day 304.|||cells/million T cells||Inter-Quartile Range|Median
2725286|NCT01059617|Secondary|Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens|"CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~The frequency was presented as number of cytokine-producing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.~Subjects with missing results were not included."|Before administration of Arepanrix vaccine (Day 0 to Day 122)|The ATP cohort for immunogenicity at Day 164 included subjects who received protocol specified vaccine(s) during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after second H1N1 vaccine dose (Day 164). Subjects with missing results were not included.|||cells/million T cells||Inter-Quartile Range|Median
2725287|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|For the entire study period up to Day 507|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.|||Subjects|||Number
2725288|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 0 and Day 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Titers||95% Confidence Interval|Geometric Mean
2725289|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 0 and 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Subjects|||Number
2725357|NCT01059357|Secondary|QOL|Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.|6 months|Data not collected on all participants|||score on a scale||Standard Deviation|Mean
2725290|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|Entire study period up to Day 507|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.|||Subjects|||Number
2725291|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122 and 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Titers||95% Confidence Interval|Geometric Mean
2725292|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Day 122 and Day 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Subjects|||Number
2725293|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725294|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
2725295|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725296|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Fold increase||95% Confidence Interval|Geometric Mean
2725297|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725298|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725312|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2725299|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725300|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
2725301|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725302|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Fold||95% Confidence Interval|Geometric Mean
2725303|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725304|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
2725305|NCT01059565|Secondary|Percentage of Missed School or Work Days|The percentage of days participants missed school or work from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of days||Standard Deviation|Mean
2725306|NCT01059565|Secondary|Percent of Days Hospitalized|The percentage of days hospitalized from baseline to Week 24 was analyzed.|Baseline to Week 24|Full Analysis Set|||percentage of days||Standard Deviation|Mean
2725307|NCT01059565|Secondary|Percentage of Days Participants Used Antibiotics|The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of days||Standard Deviation|Mean
2725308|NCT01059565|Secondary|Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24|The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||log_10 CFU per gram of sputum||Standard Error|Least Squares Mean
2725309|NCT01059565|Secondary|Change in BMI From Baseline to Week 24|The change in BMI from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||kg/m^2||Standard Error|Least Squares Mean
2725310|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2725358|NCT01059357|Secondary|Number of Correctly Predicted Success of TORS Preoperatively|This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.|preoperative||||procedures|||Number
2725313|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEF25-75|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||percent change in FEF25-75 (liters/sec)||Standard Error|Least Squares Mean
2725314|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FVC|The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||percent change in FVC (liters)||Standard Error|Least Squares Mean
2725315|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEV1|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||percent change in FEV1 (liters)||Standard Error|Least Squares Mean
2725316|NCT01059565|Secondary|AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24|"The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed.~The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2725317|NCT01059565|Secondary|Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events|The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics.|Baseline to Week 24|Full Analysis Set|||antibiotic treatment courses|||Number
2725318|NCT01059565|Primary|AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24|The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24.|Baseline to Week 24|Full Analysis Set|||percent change in FEV1% predicted||Standard Error|Least Squares Mean
2725319|NCT01059539|Secondary|Change From Baseline in the MADRS Total Score at Week 16|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale that evaluates the patient's depressive symptomatology during the previous week. Patients are rated on 10 items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point (0-6) scale. The total score can range from 0 to 42. A higher score indicates greater depressive symptomatology. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat population: All enrolled participants who took at least 1 dose of investigational product and who had a Baseline and at least 1 post-baseline assessment of the Young Mania Rating Scale.|||Units on a scale||Standard Deviation|Mean
2725320|NCT01059539|Primary|Change From Baseline in the YMRS Total Score at Week 16|The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat population: All enrolled participants who took at least 1 dose of investigational product and who had a Baseline and at least 1 post-baseline assessment of the Young Mania Rating Scale.|||Units on a scale||Standard Deviation|Mean
2725321|NCT01059526|Secondary|Overall Patient Response Assessment|"The Overall Response Assessment was to be completed every 30 minutes after treatment until patient discharge. Patients evaluated their response to treatment as a lot better or resolved, a little better, the same, a little worse, or a lot worse. The data presented is based on the best response achieved following a single dose of KALBITOR (Dose A) for the first HAE treatment episode. Responses of a lot better or resolved and a little better were combined to form a category of Better. Similarly, a little worse and a lot worse were combined to form a category of Worse. Patients treated in a clinic (study site) could have been discharged after an hour and hence may have only had 2 post-treatment evaluations (30 and 60 minutes); response assessments may not have been consistently provided when patients were treated at an alternate site outside of the study site."|within 4 hours post dose|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR. Analysis only includes episodes of patients who were treated at the study site.|||participants|||Number
2725322|NCT01059526|Primary|Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR|Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.|12 months after first treatment||||participants||95% Confidence Interval|Number
2725338|NCT01059435|Secondary|Time to Maximum Effect of Osteocalcin|Defined as the time to maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days||Full Range|Median
2725339|NCT01059435|Secondary|Maximum Effect for Osteocalcin|Defined as the maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||µg/L||Standard Deviation|Mean
2725359|NCT01059357|Secondary|Average Time to Set up and Perform Procedures|This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.|At time of surgery, up to 3 hours||||minutes||Standard Deviation|Mean
2725323|NCT01059526|Primary|Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.|"Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies.~Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered."|12 months after first treatment|Based on total number of patients who were not positive for the antibody class at study entry and had at least one post-baseline antibody evaluation. N=40 evaluable patients for all immunoglobulin antibody classes; N=41 evaluable patients for IgE to ecallantide antibodies; N=41 evaluable patients for neutralizing antibodies to ecallantide.|||participants||95% Confidence Interval|Number
2725324|NCT01059526|Primary|Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity|Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.|12 months after first treatment|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR|||participants||95% Confidence Interval|Number
2725325|NCT01059435|Secondary|Ionized Calcium Over Time||Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85|All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.|||mg/dL||Standard Deviation|Mean
2725326|NCT01059435|Secondary|Serum Calcium Over Time||Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85|All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.|||mg/dL||Standard Deviation|Mean
2725327|NCT01059435|Secondary|Percent Change From Baseline in Sclerostin||Baseline and days 15, 29, 43, 57, 71, and 85|All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed on days 71 and 85.|||percent change||Standard Deviation|Mean
2725328|NCT01059435|Secondary|Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*ng/L||Standard Deviation|Mean
2725329|NCT01059435|Secondary|Area Under the Curve From Day 0 to Day 29 (AUC0-29) for iPTH||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*ng/L||Standard Deviation|Mean
2725330|NCT01059435|Secondary|Time to Maximum Effect of iPTH|Defined as the time to maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days||Full Range|Median
2725331|NCT01059435|Secondary|Maximum Effect for Intact Parathyroid Hormone (iPTH)|Defined as the maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||ng/L||Standard Deviation|Mean
2725332|NCT01059435|Secondary|Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*µg/L||Standard Deviation|Mean
2725333|NCT01059435|Secondary|Area Under the Curve From Day 0 to Day 29 (AUC0-29) for BSAP||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*µg/L||Standard Deviation|Mean
2725334|NCT01059435|Secondary|Time to Maximum Effect of BSAP|Defined as the time to maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days||Full Range|Median
2725335|NCT01059435|Secondary|Maximum Effect for Bone-specific Alkaline Phosphatase (BSAP)|Defined as the maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||µg/L||Standard Deviation|Mean
2725336|NCT01059435|Secondary|Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for Osteocalcin||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*µg/L||Standard Deviation|Mean
2725337|NCT01059435|Secondary|Area Under the Curve From Day 0 to Day 29 (AUC0-29) for Osteocalcin||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*µg/L||Standard Deviation|Mean
2725341|NCT01059435|Secondary|Area Under the Curve From Day 0 to Day 29 (AUC0-29) for sCTX||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*ng/mL||Standard Deviation|Mean
2725342|NCT01059435|Secondary|Time to Maximum Effect of sCTX|Defined as the time to minimum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days||Full Range|Median
2725343|NCT01059435|Secondary|Maximum Effect for Serum C-telopeptide (sCTX)|Defined as the minimum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||ng/mL||Standard Deviation|Mean
2725344|NCT01059435|Secondary|Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for P1NP||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab,|All treated participants|||days*ng/mL||Standard Deviation|Mean
2725345|NCT01059435|Secondary|Area Under the Curve From Day 0 to Day 29 (AUC0-29) for P1NP||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days*ng/mL||Standard Deviation|Mean
2725346|NCT01059435|Secondary|Time to Maximum Effect of P1NP|Defined as the time to maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||days||Full Range|Median
2725347|NCT01059435|Secondary|Maximum Effect for Serum Type 1 Aminoterminal Propeptide (P1NP)|Defined as the maximum value postdose.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants|||ng/mL||Standard Deviation|Mean
2725348|NCT01059435|Secondary|Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab|The terminal (gamma, γ) phase half-life (t½,γ) was calculated from the natural log of 2 divided by the terminal rate constant (λz).|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants who received romosozumab|||days||Standard Deviation|Mean
2725349|NCT01059435|Secondary|Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab|The plateau (beta, β) phase half-life (t½,β) was calculated from the natural log of 2 divided by the beta phase rate constant (λβ). λβ for a subject was estimated by linear regression of at least 3 contiguous time points that followed the Cmax and constituted a distinct phase that preceded the terminal phase.|Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants who received 3, 5, or 10 mg/kg romosozumab|||days||Standard Deviation|Mean
2725350|NCT01059435|Secondary|Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants who received romosozumab|||mL/hr/kg||Standard Deviation|Mean
2725351|NCT01059435|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants who received romosozumab|||µg*hr/mL||Standard Deviation|Mean
2725352|NCT01059435|Secondary|Initial Concentration Following IV Administration (C0) of Romosozumab||Day 1 at the end of infusion|All treated participants who received intravenously administered romosozumab|||ng/mL||Standard Deviation|Mean
2725353|NCT01059435|Secondary|Time to Maximum Observed Concentration (Tmax) of Romosozumab||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants who received subcutaneous romosozumab|||days||Full Range|Median
2725354|NCT01059435|Secondary|Maximum Observed Concentration (Cmax) of Romosozumab||Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.|All treated participants who received subcutaneous romosozumab|||ng/mL||Standard Deviation|Mean
2725355|NCT01059435|Primary|Number of Participants Who Developed Anti-romosozumab Antibodies|Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.|Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).|All treated participants|||participants|||Number
2725356|NCT01059435|Primary|Number of Participants With Adverse Events|"Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.~Relatedness to investigational product was assessed by the investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the investigational product?'"|Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.|All treated participants|||Participants|||Count of Participants
2725362|NCT01059357|Primary|The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.|In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis|At time of surgery, lasting up to 3 hours. Assessed for up to 6 months||||Participants|||Count of Participants
2725363|NCT01059344|Post-Hoc|To Achieve Clinical Remission in the Patient Population Confirmed by the Central Reader|Clinical Remission, defined as stool frequency score of 0, rectal bleeding score of 0 and absence of urgency in subjects with adequate disease extent at baseline confirmed by central reading.|6 weeks|modified ITT, eligibility confirmed by central reader|||Participants|||Count of Participants
2725364|NCT01059344|Secondary|Improvement|Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)|10 weeks|ITT|||Participants|||Count of Participants
2725365|NCT01059344|Secondary|Improvement|Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)|6 weeks|ITT|||Participants|||Count of Participants
2725366|NCT01059344|Secondary|Endoscopic Remission|Endoscopic remission is defined as a sigmoidoscopy score of 1 or less|10 weeks|ITT|||Participants|||Count of Participants
2725367|NCT01059344|Secondary|Endoscopic Remission|Endoscopic remission is defined as a sigmoidoscopy score of 1 or less|6 weeks|ITT|||Participants|||Count of Participants
2725368|NCT01059344|Secondary|Clinical Remission|Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency|10 weeks|ITT|||Participants|||Count of Participants
2725369|NCT01059344|Primary|To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).|Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency|6 weeks|ITT|||participants|||Number
2725370|NCT01059305|Primary|Overall Response|Response Evaluation Criteria In Solid Tumors (RECIST) criteria for CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum of diameters of target lesions, reference smallest sum on study (this includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must absolute increase at least 5 mm. (Note: appearance of 1/> new lesions also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Not evaluable (NE): Inevaluable when no imaging/measurement done|4 weeks||||Participants|||Count of Participants
2725371|NCT01059175|Secondary|Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire|Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.|24 months|Number of patients with data available for analysis of this objective|||units on a scale||Standard Deviation|Mean
2725372|NCT01059175|Secondary|Changes in Echocardiographic Indexes of Left Ventricle Remodeling|Changes between baseline and 24months follow up|24 months|Number of patients with data available for analysis of this objective|||milliliter||Standard Deviation|Mean
2725373|NCT01059175|Secondary|Overall Mortality||24 months||||participants|||Number
2725374|NCT01059175|Secondary|Time to First Heart Failure Related Hospitalization||24 months||||days||Standard Error|Mean
2725375|NCT01059175|Secondary|Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study||24 months||||participants|||Number
2725376|NCT01059175|Secondary|Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study|Changes between baseline and 24months follow up|24 months||||meters||Standard Deviation|Mean
2725377|NCT01059175|Secondary|Rate of Adverse Events||24 months||||participants|||Number
2725378|NCT01059175|Secondary|"Distribution of Improved, Unchanged and Worsened Patients as Defined Per M. Packer's Clinical Composite Score"|"Distribution of improved, unchanged and worsened patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved.~Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened.~Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.~Unchanged : if none of the previous definition applies."|24 months||||participants|||Number
2725379|NCT01059175|Primary|"Distribution of Improved, Unchanged and Worsened Patients as Defined Per M. Packer's Clinical Composite Score"|"M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved.~Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened.~Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.~Unchanged : if none of the previous definition applies."|12 months||||participants|||Number
2725380|NCT01059071|Secondary|AUC of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID|||(mcg/ml) * hr||Standard Deviation|Mean
2725381|NCT01059071|Secondary|Cmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID|||mcg/ml||Standard Deviation|Mean
2725382|NCT01059071|Secondary|Tmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID|||hours||Standard Deviation|Mean
2725383|NCT01059071|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.|||participants|||Number
2725384|NCT01059071|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.|||Days||95% Confidence Interval|Median
2725385|NCT01059071|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of DFMO as a single agent and in combination with etoposide in pediatric and young adult patients with refractory or recurrent neuroblastoma|length of study plus 30 days|Received at least one dose of DFMO|||participants|||Number
2725386|NCT01058993|Primary|Blood Neutrophil Counts.|Effectiveness of drug based on increases of blood neutrophil counts to greater than 2.0 x 10^9 per liter|up to 14 days, depending on when subject reached peak response, i.e., the highest count after the stimulus (plerixafor)|The number of participants (6) was determined by the fact that we were studying a rare form of neutropenia, WHIMS syndrome, and we therefore recruited subjects who have WHIMS who live on the West coast. Analysis was per protocol.|||10^9 per Liter||Standard Deviation|Mean
2725387|NCT01058941|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months|The ADAS-cog assesses general cognitive function over multiple domains and evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates greater impairment on a range of scores from 0 to 70. A total score of 70 indicates maximum severity.|Baseline and 18 months|Twenty participants discontinued from the study prior to completing all study visits. One placebo and one treatment participant did not complete the final ADAS-cog assessment.|||units on a scale||Standard Deviation|Mean
2725388|NCT01058941|Primary|Change From Baseline in Activities of Daily Living (ADL) at 18 Months|The Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) is used to assess activities of daily living in people with AD using a structured interview to ask the AD participant's caregiver/study partner to assess functional ability over a wide range of performance measures. A higher ADL score indicates greater impairment in functional ability; scores range from 0 to 27.|Baseline and 18 months|Twenty participants discontinued from the study prior to completing all study visits. One treatment participant did not complete the final ADL assessment.|||units on a scale||Standard Deviation|Mean
2725389|NCT01058863|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 37|Safety population of all randomized participants who received at least one dose of randomized study medication.|||participants|||Number
2725390|NCT01058863|Secondary|Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)|"Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.~The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment|||% predicted * hour||Standard Error|Mean
2725391|NCT01058863|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment|||L*hour||Standard Error|Mean
2725392|NCT01058707|Secondary|Percentage Change From Baseline in Eukaryotic Initiation Factor 4E-binding Protein 1 (P4EBP1), Serine/Threonine Protein Kinase B (PAKT) and Ribosomal Protein S6 (PS6)|P4EBP, PAKT and PS6 were assayed in skin biopsies. A negative percentage change from Baseline indicates improvement.|Baseline, Cycle 1 Week 2|ASaT population included all participants who received at least 1 dose of MLN0128 in dose escalation phase. Participants with data at Baseline and Cycle 1 Week 2 are included. Number analyzed is the number of participants with data available at the given time-point.|||percentage change||Standard Deviation|Mean
2725393|NCT01058707|Secondary|Percentage Area Under Plasma Concentration Time Curve Extrapolated||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|The study was acquired from another organization and limited results data are available.||||||
2725394|NCT01058707|Secondary|Tmax: Time to Maximum Observed Plasma Concentration for MLN0128||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hours||Full Range|Median
2725395|NCT01058707|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN0128||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng*hr/mL||Full Range|Mean
2725396|NCT01058707|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng*hr/mL||Full Range|Mean
2725397|NCT01058707|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN0128||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hours||Full Range|Median
2725398|NCT01058707|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|PK population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Full Range|Mean
2725399|NCT01058707|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN0128||Pre-dose and multiple time-points up to 8 hours post-dose on Day 1 of Cycles 1 and 2|Pharmacokinetic (PK) population consisted of all participants included during the dose escalation phase of the study who received at least 1 dose of MLN0128. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Full Range|Mean
2725400|NCT01058707|Primary|Dose Expansion: Duration of Stable Disease (SD)|Duration of SD was evaluated for participants with best response of SD and is defined as number of months from date of first dose to date of PD. As per RECIST 1.1, SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined of at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions. PD is defined as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is smallest on study).|From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)|Response-Evaluable Population: participants who received ≥1 dose of MLN0128, had measurable disease at Baseline (BL), underwent ≥1 post-BL disease assessment. Participants without post-BL disease assessment but discontinued study drug due to symptomatic and/or clinical deterioration were included. SD participants with available data were analyzed.|||months||Full Range|Median
2725401|NCT01058707|Primary|Dose Expansion Phase: Duration of Objective Response|Duration of objective response is defined as the number of months from the start date of CR or PR (whichever occurred first) based on RECIST Criteria version 1.1 to the first date of objectively documented progressive disease (PD) for participants who achieved CR or PR. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)|Response-Evaluable Population:participants who received ≥1 dose of MLN0128,had measurable disease at Baseline,had ≥1 post-Baseline disease assessment.Participants without post-Baseline disease assessment but discontinued study drug due to symptomatic and/or clinical deterioration were included.CR/PR participants with available data were analyzed.|||months||Full Range|Median
2725402|NCT01058707|Primary|Dose Expansion: Objective Response Rate (ORR)|ORR is defined as the percentage of participants who achieved complete response (CR) or partial response (PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR is defined as disappearance of all target lesions and PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions. Data was categorized as per type of cancer.|From the first dose of study drug up to disease progression or death (Up to approximately 240 weeks)|Response-Evaluable Population included participants who received at least 1 dose of MLN0128, had measurable disease at Baseline, and underwent at least 1 post-Baseline disease assessment. Participants without a post-Baseline disease assessment but discontinued study drug due to symptomatic and/or clinical deterioration were included.|||percentage of participants|||Number
2725403|NCT01058707|Primary|Number of Participants Experiencing One or More Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 244 weeks)|ASaT population included all participants who received at least 1 dose of MLN0128.|||Participants|||Count of Participants
2725424|NCT01058395|Post-Hoc|Aspartate Aminotransferase (AST) Levels|"AST levels measured daily from day 1 to day 7 evaluated by ANOVA. Mean values on day 7 reported for the two tiers.~Elevations may indicate Liver dysfunction due to medication."|day 1 change to day 7 day, ANOVA, mean value on day 7 reported|Levels are compared for the two tiers|||U/L||Full Range|Mean
2725425|NCT01058395|Secondary|Drug Levels|Serum samples were collected for assessment of minocycline concentrations at the estimated time of steady-state concentrations. Serum concentrations were assessed on Day 4. Data reported will be pKa levels 2 hours after AM dose.|4 days after start|Those we were able to obtain levels on reliably and could run against standards. This only turned out to be the first tier level. Descriptive data only|||mcg/ml||Full Range|Mean
2725404|NCT01058707|Primary|Dose Escalation Phase: Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were defined as MLN0128-related treatment-emergent adverse events (TEAEs) that occurred within the Cycle 1 (first 28 days of treatment) as per Common Terminology Criteria for Adverse Events (CTCAE): Any ≥Grade 3 or non-hematologic toxicity except for Grade 3 nausea and/or vomiting and diarrhea, Grade 3 hyperglycemia lasting ≤ 14 days, Grade 3 rash lasting ≤ 3 days; Grade 4 neutropenia lasting >7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever ≥38.5 degree celsius and/or systemic infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75% of planned doses of MLN0128 within Cycle 1 due to drug-related toxicity and any clinically significant occurrence that the investigators and sponsor agreed would place participants at an undue safety risk.|Cycle 1 (28 days)|Dose Escalation-Evaluable Population included participants who received ≥ 75% or more of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs considered a DLT.|||Participants|||Count of Participants
2725405|NCT01058707|Primary|Dose Escalation Phase: Maximum Tolerated Dose (MTD)|MTD was defined as the highest dose level of MLN0128 at which no more than 1 out of 6 evaluable participants experienced a DLT during the first cycle (28 days) of therapy.|Cycle 1 (28 Days)|Dose Escalation-Evaluable Population included participants who received ≥ 75% or more of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs considered a DLT.|||milligrams (mg)|||Number
2725406|NCT01058668|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
2725407|NCT01058668|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
2725408|NCT01058655|Secondary|Overall Survival (OS) [Phase II]|OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.|Long-term follow-up for survival was not specified per protocol. Participants were followed for up to 20 months on this study.|The analysis dataset is comprised of all evaluable phase II patients.|||months||95% Confidence Interval|Median
2725409|NCT01058655|Secondary|Disease Control Rate (DCR) [Phase II]|Disease Control Rate is defined as the percentage of patients who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was assessed every 2 cycles on treatment. Median treatment duration on this study cohort was 2 months (range 1-16).|The analysis dataset is comprised of all evaluable phase II patients.|||percentage of participants||95% Confidence Interval|Number
2725410|NCT01058655|Primary|Progression-Free Survival (PFS) [Phase II]|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was assessed radiographically to document clinical progression every 2 cycles on treatment. Participants were followed for up to 16 months since study entry.|The analysis dataset is comprised of all evaluable phase II patients.|||months||95% Confidence Interval|Median
2725426|NCT01058395|Primary|Disability Rating Scale|The main outcome measure after the safety data was the Disability Rating Scale (DRS). It is a 29 point scale with 29 being a severe vegetative state. It is reliable across time and demonstrates better sensitivity than the Glasgow Outcome Scale.It has been a standard primary outcome measure for most pharmaceutical studies for TBI, and was required by the FDA for the IND approval.|4 weeks and 3 months||||units on a scale||Standard Deviation|Mean
2725427|NCT01058356|Secondary|Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)||Up to14 days||||participants|||Number
2725428|NCT01058356|Primary|Presence of AAD|AAD defined as: Watery stools more than 3 times per day for at least 2 days.|Up to 14 days||||participants|||Number
2725515|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)|Safety population per visit and per treatment group (missings not included)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.|||mg|Participants|Standard Deviation|Mean
2725411|NCT01058655|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as a treatment-related (attribution possible, probable, definite) adverse event that meets any of the following criteria: Grade 3 (G3) or higher non-hematologic toxicity (excluding, nausea, vomiting, diarrhea, alopecia, hypertension, hypercholesterolemia, or hypertriglyceridemia); G3 diarrhea, nausea or vomiting lasting > 48 hours or leading to hospitalization, despite aggressive anti-diarrheal or anti-emetic medications; G4 diarrhea, despite aggressive anti-diarrheal medications; G4 vomiting, despite aggressive anti-emetic medications; G3 hypertension, for which blood pressure cannot be reduced to <150/100 with anti-hypertensive therapies; G4 hypertension or severe hypertension, as defined by systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg; G4 hypercholesterolemia or hypertriglyceridemia lasting > 7 days, despite appropriate use of anti-hyperlipidemic medications; G4 hematologic toxicity lasting for >5 days, including leukopenia, neutropen|Patients were assessed continuously for toxicity while on study. The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for DLT. The 2 DLTs experienced by participants in dose level cohort 3 were grade 3 fatigue and dehydration.|||Participants with DLT|||Number
2725412|NCT01058655|Primary|Tivozanib Maximum Tolerated Dose (MTD) [Phase I]|The tivozanib MTD in combination with everolimus is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.|||mg daily for 3 weeks of a 4 week cycle|||Number
2725413|NCT01058655|Primary|Everolimus Maximum Tolerated Dose (MTD) [Phase I]|The everolimus MTD in combination with tivozanib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.|||mg daily for 4 weeks of a 4 week cycle|||Number
2725414|NCT01058642|Primary|Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.|Baseline, Week 2 of Treatment Period 1 or 2|Zero participants were analyzed, and no data was collected for this measure. Due to lack of efficacy of ADL5747, the study was terminated early.||||||
2725415|NCT01058421|Secondary|Institution Free Days|Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.|Day 180|"Deceased subjects were not included in subsequent Period beginning subject started totals.~55 (subjects started Period 1) minus 13 (deceased subjects in Periods 1 & 2) = 46 started Period 3.~61 (subjects started Period 1) minus 11 (deceased subjects in Periods 1 & 2) = 50 started Period 3."|||Days||Inter-Quartile Range|Median
2725416|NCT01058421|Secondary|Institution Free Days|Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.|At Day 90|"Deceased subjects were not included in subsequent Period beginning subject started totals.~59 (Subjects started Period 1) minus 10 (deceased subjects during Period 1) = 49 started Period 2.~61 (Subjects started Period 1) minus 6 (deceased subjects during Period 1) = 55 started Period 2."|||Days||Inter-Quartile Range|Median
2725417|NCT01058421|Secondary|Discharged to Home|Percentage of subjects discharged to home from study hospital|Through Day 28||||percentage of participants|||Number
2725418|NCT01058421|Secondary|Hospital Length of Stay|The total number of hospital days during study participation, up to 180 days.|up to 180 days||||Days||Inter-Quartile Range|Median
2725419|NCT01058421|Secondary|Hospital Free Days||Through Day 28||||Days||Inter-Quartile Range|Median
2725420|NCT01058421|Secondary|Mechanical Ventilation Duration|The total number of ventilated days from hospital admission to extubation, death or discharge over the complete duration of study participation, up to 180 days.|up to 180 days||||Days||Inter-Quartile Range|Median
2725421|NCT01058421|Secondary|ICU Length of Stay|Median ICU length of stay through Day 28|Total Days through Day 28||||Days||Inter-Quartile Range|Median
2725422|NCT01058421|Secondary|ICU-free Days|Number of ICU-free days at Day 28.|Day 28||||Days||Inter-Quartile Range|Median
2725423|NCT01058421|Primary|The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10|The CS-PFP-10 provides an overall score and scores for upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance. The test is used to assess an individual's overall capacity to carry out activities of daily living by measuring and quantifying 10 typical activities including sweeping a floor, transferring clothes from a washer to a dryer, and carrying groceries. Tasks are quantified using time alone, time and weight, and distance. This test provides a realistic and practical measure of movement capacity and ability to accomplish sustained activity. CS-PFP-10 scores are scored from 0 to 100, with higher scores indicating better function. If patients remained in the hospital or in a long-term care facility a the time of assessment, then received a score of 0. All tests were conducted in a standardized physical therapy laboratory by a physical therapist formally trained in conducting the CS-PFP-10 and blinded to group/arm assignment.|1 month|41 of 59 subjects were analyzed in the Intensive Treatment Group (20 completed outcomes testing + 5 remained in hospital + 16 remained in another facility = 41 subjects). 48 of 61 Standard of Care Group subjects were analyzed (19 completed outcomes testing + 12 remained in hospital + 17 remained in another facility = 48).|||score||Standard Error|Mean
2725429|NCT01058304|Secondary|Short Performance Physical Battery (SPPB)|"This battery of objective physical function tests examines participants' balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12 weeks|All enrolled, randomized participants|||units on a scale||95% Confidence Interval|Mean
2725430|NCT01058304|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12-weeks, 24-weeks|All enrolled, randomized participants|||units on a scale||95% Confidence Interval|Mean
2725431|NCT01058265|Primary|Short Form 36 (SF-36) Mental Component Summary (MCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months||||Scores on a scale||Inter-Quartile Range|Median
2725432|NCT01058265|Primary|Short Form 36 (SF-36) Physical Component Summary (PCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months||||Scores on a scale||Inter-Quartile Range|Median
2725433|NCT01058239|Secondary|Treatment Related Toxicities|The toxicities experienced by participants that were deemed to be related to the study treatment. Data is shown as the number of participants that experienced any grade toxicity that was deemed to be related to treatment. Toxicities were assessed with the use of Common Toxicology Criteria for Adverse Events (CTCAE).|2 years||||participants|||Number
2725434|NCT01058239|Secondary|Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load|The Mean epstein barr virus (EBV) viral load at the given time points.|baseline, 21, 42, 63, 84 days (end of cycles 1, 2, 3, 4)|Not all participants completed four cycles of treatment. The number of participants analyzed in each row differs according to the number of participants available for analysis at each time point.|||Log2[(viral copies/ milliliter blood)+1]||Standard Deviation|Mean
2725435|NCT01058239|Secondary|Overall Survival|The percent of participants surviving at 6 months and 1 year.|6 months, 1 year||||percentage of participants||90% Confidence Interval|Number
2725436|NCT01058239|Secondary|Six-Month Progression Free Survival|"Percent of participants with progression free survival (alive without disease progression) six months after registration. Progression was evaluated using the International Working Group criteria for lymphoma response.~> Progressive Disease (PD) or Relapsed Disease (RD):~Appearance of any new lesion > 1.5 cm in any axis during or at end of therapy. Increased Radiolabeled[18F]-2-fluoro-2-deoxy-D-glucose (FDG) uptake in a previously unaffected site will be considered PD/RD only after confirmation by other modalities.~≥ 50% increase from nadir in the sum of the products of the largest diameters (SPD) of any previously involved node, or in a single involved node, or in the sizes of other lesions.~≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis.~PET (positron emission tomography) positive prior to therapy: post-treatment PET should be positive unless lesion is too small to be detected with current PET sys"|six months||||percentage of participants||90% Confidence Interval|Number
2725437|NCT01058239|Secondary|Complete Response Rate|"The number of participants with complete responses as assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response.~Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy."|4 Months||||Participants|||Count of Participants
2725438|NCT01058239|Primary|Overall Response Rate|"Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response. The complete list of criteria used to evaluate response is too long to be detailed in the allotted space here, but response is defined more generally as:~Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~Partial Response (PR): ≥ 50% decrease in the sum of the products of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses."|4 months||||Participants|||Count of Participants
2725439|NCT01058096|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
2725516|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)|Safety population per visit and per treatment group|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.|||mg|Participants|Standard Deviation|Mean
2725440|NCT01058096|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
2725441|NCT01058070|Primary|To Monitor the Improvement of GERD Symptoms.|Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms|5 years||||percentage of participants|||Number
2725442|NCT01058070|Primary|To Evaluate the Incidence of All Adverse Events at Various Time Points.||5 years||||participants|||Number
2725443|NCT01058005|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.|up to 108 Weeks|Participants who received at least 1 dose of study medication.|||participants|||Number
2725444|NCT01057901|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.|||units on a scale||Standard Error|Least Squares Mean
2725445|NCT01057901|Primary|Change From Baseline in the Number of Satisfying Sexual Events|"The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).~Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question."|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.|||SSEs/month||Standard Deviation|Mean
2725446|NCT01057888|Primary|Well Child Care Status|Received recommended well child care visit|12 months||||participants|||Number
2725447|NCT01057888|Primary|Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))||12 months|Individuals were randomized to one of 3 groups (letter reminders, telephone reminders or control). Individuals with a wrong/missing telephone number or a wrong address were excluded from the analyses. This left 1,396 in the letter reminder group, 1,423 in the telephone reminder group and 1,296 in the control group.|||participants|||Number
2725448|NCT01057862|Secondary|Gambling Symptom Assessment Scale (G-SAS)|The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each item on the 12-item scale has a score ranging from 0 - 4. All items ask for an average symptom based on the past 7 days. Total score ranges from 0 - 48: extreme = 41 - 48, severe = 31 - 40, moderate = 21 - 30, mild = 8 - 20.|Weekly/bi-weekly visits|Enrollment was lower than expected and due to the low numbers of subjects completing the study (8 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.|||units on a scale||Standard Deviation|Mean
2725449|NCT01057862|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)|The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.|Weekly/bi-weekly visits|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions - 5 naltrexone and 2 placebo) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.|||units on a scale||Standard Deviation|Mean
2725560|NCT01056718|Secondary|Peak Stress Diastolic BP||10 Week||||mm Hg||Standard Deviation|Mean
2725561|NCT01056718|Secondary|Peak Stress Systolic BP||10 Week||||mm Hg||Standard Deviation|Mean
2725450|NCT01057810|Secondary|Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities|"NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:~White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.~Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L.~Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN."|Randomization up to April 2015, approximately 57 months|All treated participants with on-study laboratory results|||participants|||Number
2725451|NCT01057810|Secondary|Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 1 of study therapy to last dose plus 70 days|All treated participants|||participants|||Number
2725452|NCT01057810|Secondary|Time to Pain Progression|"Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10).~Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism."|Randomization until pain progression, up to April 2015, approximately 57 months|All randomized participants|||months||95% Confidence Interval|Median
2725453|NCT01057810|Secondary|Time to Subsequent Non-hormonal Cytotoxic Therapy|For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).|Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months|All randomized participants who received subsequent non-hormonal cytotoxic therapy|||months||95% Confidence Interval|Median
2725454|NCT01057810|Secondary|Progression-Free Survival (PFS) Time|Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.|Randomization until disease progression, up to April 2015, approximately 57 months|All randomized participants|||months||95% Confidence Interval|Median
2725455|NCT01057810|Primary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.|Randomization until death from any cause, up to April 2015, approximately 57 months|All randomized participants|||months||95% Confidence Interval|Median
2725456|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)|"GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported."|Week 19|"FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||participants|||Number
2725457|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)|"GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported."|Week 6|"SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||participants|||Number
2725458|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725562|NCT01056718|Secondary|Diastolic BP||10 Week||||mm Hg||Standard Deviation|Mean
2725459|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.|||units on a scale||Standard Deviation|Mean
2725460|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725461|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.|||units on a scale||Standard Deviation|Mean
2725462|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Double-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
2725463|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Single-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.|||mm||Standard Deviation|Mean
2725464|NCT01057693|Secondary|Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725465|NCT01057693|Secondary|Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time point.|||units on a scale||Standard Deviation|Mean
2725466|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Double-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725467|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Single-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725637|NCT01056315|Primary|Average Pain Intensity|The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).|Baseline; last 7 days of 12-week maintenance|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725468|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Double-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2725469|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Single-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.|||units on a scale||Standard Deviation|Mean
2725470|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.|||participants|||Number
2725471|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.|||participants|||Number
2725472|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2725473|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here “n” signifies participants who were evaluable for specified time-point.|||units on a scale||Standard Deviation|Mean
2725474|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Double-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2725475|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Single-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2725476|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.|||percentage of participants|||Number
2725501|NCT01057225|Secondary|Stem Cell Collection and Engraftment (Phase II)|For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.|Following the first 4 courses of treatment|Of the 64 patients that began protocol treatment, stem cell harvesting was attempted on 42 patients.|||participants|||Number
2725477|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.|||percentage of participants|||Number
2725478|NCT01057693|Secondary|Weekly Mean Pain Scores (Double-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2725479|NCT01057693|Secondary|Weekly Mean Pain Scores (Single-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.|Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time-point.|||units on a scale||Standard Deviation|Mean
2725480|NCT01057693|Secondary|Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 6 (SB Phase)|Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. “N” (number of participants analyzed): participants who were evaluable for this measure and “n”: participants who were evaluable for specified time-point. Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2725481|NCT01057693|Secondary|Time to Loss of Pain Response (Double-Blind Phase)|Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline up to Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.|||days||95% Confidence Interval|Median
2725482|NCT01057693|Primary|Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 19 (DB Phase)|Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2725483|NCT01057589|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)|PQ Population: all randomized and treated participants with evaluable data at respective timepoint.|||units on a scale||Standard Deviation|Mean
2725484|NCT01057589|Secondary|Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy|EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 [no limitation], 2 [some limitation] or 3 [severe or complete limitation] in 5 dimensions [mobility, self-care, usual activities, pain/comfort and anxiety/depression]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).|Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.|||units on a scale||Standard Deviation|Mean
2725485|NCT01057589|Secondary|Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy|Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).|Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data for each category|||units on a scale||Standard Deviation|Mean
2725486|NCT01057589|Secondary|Percent of Participants With a Partial Response (PR) or a Complete Response (CR)|CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of first response to PD (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.|||percentage of participants||95% Confidence Interval|Number
2725487|NCT01057589|Secondary|Overall Survival (OS)|OS defined as the time from the date of first dose of study drug to the date to death from any cause.|Baseline to date of death up to 18.7 months|PQ Population: all randomized and treated participants|||months||95% Confidence Interval|Median
2725488|NCT01057589|Primary|Progression Free Survival (PFS)|PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to date of PD or death up to 18.7 months|Protocol Qualified (PQ) Population: all randomized and treated participants|||months||95% Confidence Interval|Median
2725489|NCT01057433|Secondary|Adverse Events||24 Days|||||||
2725490|NCT01057433|Primary|Area Under the Curve From Time 0 to Tau (AUC 0-τ)|Area under the curve from start to elimination.|12 hours||||ng•h/mL||Standard Deviation|Mean
2725491|NCT01057394|Primary|Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation|Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).|3 Months|Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.|||isolated pulmonary veins|||Number
2725492|NCT01057277|Primary|Response||1 year||||participants|||Number
2725493|NCT01057251|Primary|Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline (Week 0) to Visit 4 (Week 6)||||mm Hg||Standard Deviation|Mean
2725494|NCT01057251|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)||||mm Hg||Standard Deviation|Mean
2725495|NCT01057225|Secondary|Overall Survival (24 Month)|24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of patients||95% Confidence Interval|Number
2725496|NCT01057225|Secondary|Overall Survival (12 Month)|12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of patients||95% Confidence Interval|Number
2725497|NCT01057225|Secondary|Progession Free Survival (24 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.|24 months|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of participants at 24 months||95% Confidence Interval|Number
2725498|NCT01057225|Secondary|Progression Free Survival (12 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.|12 months|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of participants at 12 months||95% Confidence Interval|Number
2725499|NCT01057225|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|From baseline to death||||months||95% Confidence Interval|Median
2725500|NCT01057225|Secondary|Complete Response (Phase II)|In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.|Following the first 4 courses of treatment||||participants|||Number
2725502|NCT01057225|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier|From baseline to end of active treatment|All enrolled patients who began treatment were evaluated for safety and response.|||months||95% Confidence Interval|Number
2725503|NCT01057225|Secondary|Progression-free Survival (Phase II)|"PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following:~• Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~• Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder"|From baseline to progression or death up to 3 years|All of the 64 participants that were eligible and began treatment were evaluated.|||months||95% Confidence Interval|Number
2725504|NCT01057225|Primary|Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)|"The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients.~A complete response is defined as:~Negative immunofixation of the serum and urine~If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio~< 5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytomas~A very good partial response is defined as:~Serum and urine M-component detectable by immunofixation but not on electrophoresis or~If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent~Urine M-component <100 mg per 24 hour"|Following the first 4 cycles of treatment (28 day cycles)|All enrolled patients who began treatment were evaluated for safety and response.|||percentage of participants|||Number
2725505|NCT01057225|Primary|Maximum Tolerated Dose (Phase I)|"To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.~For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.~We are reporting the number of DLTs"|From baseline to end of active treatment, up to 12 28-day cycles.|All patients registered to a dose escalation Phase I group were analyzed for this endpoint.|||participants|||Number
2725506|NCT01057121|Other Pre-specified|Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load|Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.|Up to 30 days after completion of study treatment|The KSHV (HHV-8) assays were run, but the results were unreliable.||||||
2725507|NCT01057121|Secondary|Time to Response|"time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks.~Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Participants who had a complete or partial responses|||weeks||Full Range|Median
2725508|NCT01057121|Secondary|Time to Relapse|Percentage of participants who relapsed|Up to 30 days after completion of study treatment|Patients who relapsed||||||
2725509|NCT01057121|Secondary|Time to Death|Percentage of patients who died|Up to 30 days after completion of study treatment|Study participants who died on study.|||percentage of participants who died|||Number
2725510|NCT01057121|Primary|Tumor Response Rate|"Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks.~Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.|||percent of participants who responded||95% Confidence Interval|Number
2725511|NCT01057121|Primary|Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)|Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.|28 days|Only patients in the phase I portion of the study were evaluated for this outcome measure.|||mg per day of lenalidomide|||Number
2725512|NCT01057017|Primary|Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab|To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3|every 3 weeks until patient comes off study (progressive disease), for up to 2 years||||participants|||Number
2725513|NCT01056913|Secondary|Clinical Relevant Stenosis||six months|||||||
2725514|NCT01056913|Primary|Anastomotic Leakage||4-8 weeks||||participants|||Number
2725517|NCT01056822|Secondary|Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group|Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.|||days|Participants|Standard Deviation|Mean
2725518|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included|||scores on a scale|Participants|Standard Deviation|Mean
2725519|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
2725520|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725521|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725522|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725523|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725524|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725525|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725526|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725527|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included|||scores on a scale|Participants|Standard Deviation|Mean
2725528|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725529|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
2725530|NCT01056822|Secondary|Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.|The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
2725531|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
2725563|NCT01056718|Primary|Metabolic Equivalent (METS) Level|METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.|10 Weeks||||METS||Standard Deviation|Mean
2725564|NCT01056718|Primary|Exercise Duration||10 Weeks||||Seconds||Standard Deviation|Mean
2725565|NCT01056718|Primary|Resting Systolic BP||10 Weeks||||mm Hg||Standard Deviation|Mean
2725532|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Item Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
2725533|NCT01056822|Secondary|Glomerular Filtration Rate (GFR) Using Abbreviated MDRD|Calculated GFR (MDRD formula): GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R where C is the serum concentration of creatinine [mg/dL], A is age [years], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||mL/min/1.73m^2||Standard Deviation|Mean
2725534|NCT01056822|Secondary|Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl)||Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||ml/min|Participants|Standard Deviation|Mean
2725535|NCT01056822|Primary|Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Per protocol (PP) population included all subjects from the ITT population who received medication throughout the study and did not have major protocol deviations and who participated in the study for a minimum of 210 days +/- 15 days|||mg/day||Standard Deviation|Mean
2725536|NCT01056822|Primary|Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||Participants|||Number
2725537|NCT01056822|Primary|Number of Participants That Achieved One Dose Step Higher With Mycophenolic Acid (MPA) or Mycophenolate Mofetil (MMF), According to the Treatment Group Assigned at the End of the Study (Final Visit) Compared to Baseline Dose||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||study participants|||Number
2725538|NCT01056822|Primary|Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||number of participants|||Number
2725539|NCT01056718|Secondary|Quality of Life|"Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the best imaginable health state and 0 is the worst imaginable health state."|10 Weeks||||units on a scale||Standard Deviation|Mean
2725540|NCT01056718|Secondary|Pulmonary Vein Peak Diastolic Velocity||10 Week||||cm/s||Standard Deviation|Mean
2725541|NCT01056718|Secondary|Pulmonary Vein Peak Systolic Velocity||10 Week||||cm/s||Standard Deviation|Mean
2725542|NCT01056718|Secondary|E/e' Ratio||10 Week||||Ratio||Standard Deviation|Mean
2725543|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (a')||10 Week||||cm/s||Standard Deviation|Mean
2725544|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (e')||10 Week||||cm/s||Standard Deviation|Mean
2725545|NCT01056718|Secondary|Mitral Valve Deceleration Time||10 Week||||ms||Standard Deviation|Mean
2725546|NCT01056718|Secondary|Mitral Valve E/A Ratio|mitral valve doppler E velocity to A velocity|10 Week||||Ratio||Standard Deviation|Mean
2725547|NCT01056718|Secondary|Mitral Valve Inflow (A) Velocity||10 Week||||cm/s||Standard Deviation|Mean
2725548|NCT01056718|Secondary|Mitral Valve Inflow (E) Velocity||10 Week||||cm/s||Standard Deviation|Mean
2725549|NCT01056718|Secondary|LV Mass||10 week||||grams||Standard Deviation|Mean
2725550|NCT01056718|Secondary|LV End Systolic Diameter||10 week||||cm||Standard Deviation|Mean
2725551|NCT01056718|Secondary|LV End Diastolic Diameter||10 week||||cm||Standard Deviation|Mean
2725552|NCT01056718|Secondary|Stress Cardiac Output||10 week||||L per minute||Standard Deviation|Mean
2725553|NCT01056718|Secondary|Resting Cardiac Output||10 week||||L per minute||Standard Deviation|Mean
2725554|NCT01056718|Secondary|Stress Stroke Volume||10 week||||ml||Standard Deviation|Mean
2725555|NCT01056718|Secondary|Resting Stroke Volume||10 weeks||||ml||Standard Deviation|Mean
2725556|NCT01056718|Secondary|Stress EF||10 Week||||Percent of LV end diastolic volume||Standard Deviation|Mean
2725557|NCT01056718|Secondary|Resting EF||10 Weeks||||Percent of LV end diastolic volume||Standard Deviation|Mean
2725558|NCT01056718|Secondary|Stress Heart Rate||10 Week||||Beats per Minute||Standard Deviation|Mean
2725559|NCT01056718|Secondary|Resting Heart Rate||10 Week||||Beats per Minute||Standard Deviation|Mean
2725566|NCT01056653|Secondary|Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale|25-item self-report measure composed of 3 subscales: Evaluation (11 items), Centrality (8 items), and Life Change (6 items). Each item is rated on a 9-point scale and subscale scores are obtained by averaging the scores of all items on a subscale; the range for all subscales is therefore 1 - 9. Higher scores reflect having more of the attribute being measured.|When the infant was 8 months old, adjusting for prematurity|Goup A Teal n = 45 due to missing data|||Scores on a scale||Standard Deviation|Mean
2725567|NCT01056653|Secondary|Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)|"A 120-item self-report questionnaire of parenting stress with two domains. The Parent Domain (51 items) measures stress related to parental functioning, the Child Domain (50 items) measures child qualities and characteristics that contribute to stress in the parent-child system. The PSI-3 contains an additional Life Stress scale (19 items) which was not used in the study.~The range of possible scores in the Parent Domain is 50 - 250 and in the Child Domain is 51 - 255. In both domains, higher scores indicate more stress."|When the infant was 8 months old, adjusting for prematurity|Group A Teal n = 44 due to missing data|||Scores on a scale||Standard Deviation|Mean
2725568|NCT01056653|Primary|Parent Child Interaction Teaching Scale (PCITS)|"Assesses parent-infant interaction skills. Used for children from birth to 3 years of age. It is an observational measure of the presence of behaviours in parent-infant interactions.~The Parent Total (50 items) is the sum of 4 subscales: Sensitivity to Cues (11 items), Response to Distress (11 items), Social-Emotional Growth Fostering (11 items), and Cognitive Growth Fostering (17 items). Higher scores on all subscales and higher total scores reflect more optimal parent-infant interactions.~Possible ranges of scores are as follows: Parent Total (0 - 50), Sensitivity to Cues (0 - 11), Response to Distress (0 - 11), Social-Emotional Growth Fostering (0 - 11), and Cognitive Growth Fostering (0 - 17)"|When the infant was 8 months old, adjusting for prematurity||||Scores on a scale||Standard Deviation|Mean
2725569|NCT01056640|Primary|Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease.||12 months|This study utilized an intent-to-treat method. Everyone randomized to study was included in the analysis|||hospitalizations||Standard Deviation|Mean
2725570|NCT01056601|Secondary|Duration of Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).|Up to 1 Year||||Weeks|||Number
2725571|NCT01056601|Secondary|Number of Participants by Tumor Response|Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|Up to 1 Year||||Participants|||Number
2725572|NCT01056601|Primary|Progression-Free Survival|Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|Up to 1 Year||||Months||95% Confidence Interval|Median
2725573|NCT01056536|Secondary|Number of Subjects Who Used Condoms Inconsistently||10 days after returning from abroad||||Participants|||Count of Participants
2725574|NCT01056536|Primary|Number of Subjects Who Had New Sexual Relationships||10 days after returning from abroad||||Participants|||Count of Participants
2725575|NCT01056523|Secondary|Blast Response|Blast response was defined as a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days.|2-3 years|Only patients treated for 28 days or more were evaluable for response.|||Participants|||Count of Participants
2725576|NCT01056523|Secondary|Partial Response|Partial response was defined as 5 to 25% blasts in the bone marrow and Hgb >100g/L, platelets >100,000/ul and neutrophils >1000/ul.|2-3 years|Only patients treated for 28 days or more were assessed for response.|||Participants|||Count of Participants
2725577|NCT01056523|Secondary|Complete Response Rate|Defined as <5% blasts in the bone marrow and a hgb 100 g/L, platelets 100,000/uL, neutrophils 1000/uL.|2-3 years|Only patients treated for at least 28 days were evaluable for response.|||Participants|||Count of Participants
2725578|NCT01056523|Secondary|Overall Response Rate|Overall response rate comprises complete response (<5% blasts in the bone marrow, and in the peripheral blood Hgb more than or equal to 100 g/L, platelets more than or equal to 100x10-9/L, and neutrophils more than or equal to 1x10-9/L), partial response (5 to 25% blasts in the bone marrow and same peripheral blood parameters) and blast response (a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days).|2-3 years|Only patients treated for 28 days or more were evaluable for response.|||Participants|||Count of Participants
2725579|NCT01056523|Primary|Recommended Phase II Dose (RP2D) of Ribavirin When Given in Combination With Low-dose Ara-C|This 3+3 designed aimed to determine recommended phase II dose (RP2D) based on pharmacokinetics (PK) and maximum tolerated dose (MTD). For the dose to be selected, a target steady state level of ribavirin 20 uM was needed for all patients and no more than 1 of 6 patients could have had dose limiting toxicity at that dose.|56 days||||mg|||Number
2725580|NCT01056510|Secondary|Proportion of Malignant B-cells in Normal B-cells Among Participants With a Positive Outcome for MRD in the First-Line Subpopulation|The proportion of malignant B-cells in normal B-cells was quantitatively determined, and was calculated as the number of malignant B-cells divided by the number of normal B-cells observed.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with a positive outcome for MRD were included in the analysis.|||proportion||Standard Deviation|Mean
2725581|NCT01056510|Secondary|Number of Participants With Positive and Negative Outcome for MRD in the First-Line Subpopulation|Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001, and positive MRD was defined as a proportion of malignant B-cells in normal B-cells >/= 0.0001.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with available MRD data (MRD-evaluable participants) were included in the analysis.|||participants|||Number
2725582|NCT01056510|Secondary|Percentage of Participants Achieving Molecular Response in the First-Line Subpopulation|Molecular response was defined as negative minimal residual disease (MRD) during study treatment or within 4 months after the end of treatment. Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001. The percentage of participants achieving molecular response was calculated as the number of participants with negative MRD divided by the number of participants analyzed.|Up to 4 months after the last treatment cycle (up to 40 weeks)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR during study treatment or within 4 months after the end of treatment were considered in the analysis.|||percentage of participants|||Number
2725583|NCT01056510|Secondary|Overall Survival (OS) in the First-Line Subpopulation|OS was defined as the time from recorded diagnosis to death from any cause. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
2725584|NCT01056510|Secondary|Percentage of Participants Experiencing Death in the First-Line Subpopulation|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
2725585|NCT01056510|Secondary|Duration of Response in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nPR to the first documentation of PD or death, whichever occurred first. Duration of response was calculated in months as [first event date minus first assessment date of CR/CRi/PR/nPR plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.|||months||95% Confidence Interval|Median
2725586|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR, CRi, PR, or nPR Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.|||percentage of participants|||Number
2725587|NCT01056510|Secondary|Time to Next Leukemia Treatment (TNLT) in the First-Line Subpopulation|TNLT was defined as the time from the first dose of trial treatment to the first documentation of any new leukemia treatment. TNLT was calculated in months as [first new treatment date minus first dose date plus 1] divided by 30.44.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
2725588|NCT01056510|Secondary|Percentage of Participants With Documented Intake of New Leukemia Therapy in the First-Line Subpopulation|The percentage of participants with documented intake of new (post-trial) leukemia therapy was calculated as the number of participants with new therapy divided by the number of participants analyzed, multiplied by 100.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
2725589|NCT01056510|Secondary|Event-Free Survival (EFS) in the First-Line Subpopulation|The criteria for PD and SD are identified in previous outcome measure(s). EFS was defined as the time from the first dose of trial treatment to the first documentation of PD, the beginning of new treatment for any hematologic malignancy, or death from any cause. Those with SD were considered event-free. EFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
2725590|NCT01056510|Secondary|Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
2725591|NCT01056510|Secondary|Disease-Free Survival (DFS) in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as [first event date minus first assessment date of CR/CRi plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.|||months||95% Confidence Interval|Median
2725592|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.|||percentage of participants|||Number
2725593|NCT01056510|Secondary|Progression-Free Survival (PFS) in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
2725594|NCT01056510|Secondary|Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
2725595|NCT01056510|Secondary|Percentage of Participants by Disease Response Category in the First-Line Subpopulation|The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by >/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by >/= 50% with >/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment.|After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
2725596|NCT01056510|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation|The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection|ITT Population (First-Line Subpopulation)|||percentage of participants||95% Confidence Interval|Number
2725597|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (Second-Line Subpopulation): A subset of participants requiring a second-line regimen for CLL.|||percentage of participants|||Number
2725598|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population|||percentage of participants|||Number
2725611|NCT01056380|Secondary|Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||hours||Inter-Quartile Range|Median
2725612|NCT01056380|Secondary|Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)||Up to 28 days|All subjects who received at least one dose of study medication.|||hours||Inter-Quartile Range|Median
2725599|NCT01056510|Primary|Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (<) 4 times 10^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (>/=) 1.5 times 10^9 cells/L, platelets greater than (>) 100 times 10^9 cells/L, and hemoglobin > 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with < 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (First-Line Subpopulation): A subset of participants requiring a first-line regimen for CLL.|||percentage of participants|||Number
2725600|NCT01056484|Primary|Time to Relapse (Resumption of Drinking)|Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.|26 weeks|Only 105 participants provided data for this measure at 26-week follow up; due to participants either: declining participation for the visit, being unable to reach within the 26-week follow up time, or withdrawing from the study before 26-week follow up. Of the 105, 3 meditation/0 controls met criteria for having relapsed during this time frame.|||number of days to relapse||Standard Deviation|Mean
2725601|NCT01056484|Primary|Percent Days Abstinent From Alcohol|Measures percent days abstinent from alcohol|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.|||percent of days abstinent from alcohol||Standard Deviation|Mean
2725602|NCT01056484|Secondary|Subject Treatment Adherence|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.|8 weeks|"Of 64 enrolled participants, one withdrew prior to the first intervention session. This participant's data was included in the baseline data analyses; this participant's meditation intervention attendance was counted as 0."|||Percentage of meditation participants|||Number
2725603|NCT01056484|Secondary|Subject Treatment Satisfaction|Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').|8 weeks|48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed.|||points||Standard Deviation|Mean
2725604|NCT01056484|Secondary|Drinker Inventory of Consequences|Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time).|26 weeks|Only 98 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.|||Scores on a scale||Standard Deviation|Mean
2725605|NCT01056484|Primary|Percent Heavy Drinking Days|Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.|||percentage of heavy drinking days||Standard Deviation|Mean
2725606|NCT01056380|Secondary|Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)||4 days|All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.|||Quantitative PCR RNA Copies||Standard Deviation|Mean
2725607|NCT01056380|Secondary|Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)||28 days|All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.|||hours||Inter-Quartile Range|Median
2725608|NCT01056380|Secondary|Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||Participants|||Count of Participants
2725609|NCT01056380|Secondary|Time Lost From Work (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||hours||95% Confidence Interval|Least Squares Mean
2725610|NCT01056380|Secondary|Overall Severity of Disease Score|Subjects recorded a severity score for 10 flu symptoms on a 0-3 scale BID for 7-14 days.The severity score for each symptom was multiplied by the number of hours scored at that severity for the entire time the subject maintained a diary (a sneezing score of 1 for 12 hours and 0 for 10 hours =1*12 + 0*10=12). This is symptom severity score*hours.Symptom severity score*hours for each of the symptoms were added for an overall symptom severity score*hours (if symptom severity score*hours for 10 symptoms were 12, 10, 9, 8, 7, 10, 10, 10, 5, 5, overall symptom severity score*hours=86).Overall symptom severity score*hours were divided by the number of hours that the subject kept a diary for a standardized continuous measure of severity of the course of illness (if overall symptom severity score*hours=86 and the subject maintained a diary for 100 hours Overall Severity of Disease Score=0.86). Overall Severity of Disease Score can range 0-30 with higher scores indicating more severe symptoms.|Up to 14 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||overall severity score||Standard Deviation|Mean
2725616|NCT01056341|Primary|Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.||6 months|After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.|||percentage of participants|||Number
2725617|NCT01056341|Primary|Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.||6 months|Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.|||percentage of participants|||Number
2725618|NCT01056328|Secondary|Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs|Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)|12 months||||participants|||Number
2725619|NCT01056328|Secondary|Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period||12 months||||participants|||Number
2725620|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite.||12 months||||participants|||Number
2725621|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite|Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.|7 days||||participants|||Number
2725622|NCT01056328|Primary|Confirmation of Entrance Block in the Pulmonary Veins||20 minutes after initial isolation||||participants|||Number
2725623|NCT01056315|Secondary|Assessment of Rescue Medication Usage During the 4-week Titration.||4-week titration phase|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725624|NCT01056315|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy.||Baseline to time to treatment discontinuation|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725625|NCT01056315|Secondary|Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725626|NCT01056315|Secondary|Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725627|NCT01056315|Secondary|EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725628|NCT01056315|Secondary|Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725629|NCT01056315|Secondary|Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).||Day 29, Day 71 and Day 113.|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725630|NCT01056315|Secondary|Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)||Baseline, weekly mean|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725631|NCT01056315|Secondary|Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).||Baseline, weekly mean|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725632|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.||Baseline, weekly mean|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725633|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).||Baseline; weekly mean|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725634|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.||Baseline; daily scores over each week of maintenance|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725635|NCT01056315|Secondary|Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).||Baseline, Last 7 days of 12-week maintenance|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725636|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance||Baseline, Daily scores over entire 12 week maintenance|Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.||||||
2725638|NCT01056289|Secondary|Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms|Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population|||percentage of participants|||Number
2725639|NCT01056289|Secondary|Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase|Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population (Double-blind phase): all participants who received at least 1 dose of study treatment and were randomized into the Double-blind treatment phase.|||percentage of participants|||Number
2725640|NCT01056289|Primary|Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase|Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2).|Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)|Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center.|||scores on a scale||Standard Error|Mean
2725641|NCT01056276|Secondary|Overall Response Rate|The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.|every 4 weeks for approximately 2 years|All patients evaluable for response.|||participants|||Number
2725642|NCT01056276|Secondary|Overall Survival|Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive.|every 4 weeks until progressive disease then every 12 weeks, projected 48 months|All patients evaluable for response.|||months||95% Confidence Interval|Median
2725643|NCT01056276|Secondary|Progression Free Survival|Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater.|every 8 weeks for up to 48 months||||months||Full Range|Median
2725644|NCT01056276|Primary|Number of Patients Who Experienced Serious and Non-serious Adverse Events|All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.|approximately 36 weeks|All patients who received at least one dose of BBD treatment.|||participants|||Number
2725645|NCT01056276|Primary|Complete Response Rate|Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.|every 8 weeks for approximately 48 months|All patients evaluable for response.|||percentage of participants|||Number
2725646|NCT01056263|Primary|Overall Survival (OS)|Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline until death or up to Year 5|Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).|||Days||95% Confidence Interval|Median
2725647|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Control Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat|||square centimeters||Standard Deviation|Mean
2725648|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Santyl Treatment Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat|||square centimeters||Standard Deviation|Mean
2725649|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up||baseline and 84 days|Intent-to-Treat population|||percentage of baseline wound area||Standard Error|Mean
2725650|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at End of Treatment||baseline and 28 days|Intent-to-Treat population|||percentage of baseline wound area||Standard Error|Mean
2725651|NCT01056198|Primary|Bates-Jensen Wound Assessment Score - Modified (BWAT-m)|The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).|baseline and 28 days|Intent-to-Treat population|||units on a scale||Standard Deviation|Mean
2725664|NCT01055886|Secondary|Abstinence as Measured by Exhaled Carbon Monoxide (CO)|This outcome reflects the number of participants whose exhaled carbon monoxide (CO; a measure of smoking) indicated abstinence (i.e., 6 parts per million or less) at Session 12, which occurred six weeks post-quit.|Session 12, 6 weeks post-quit|Data was available on 30 participants who attended Session 12.|||participants|||Number
2725652|NCT01056107|Secondary|Stool Consistency Post Treatment|"The subjects rated their stool consistency using the 7-point Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea. The Bristol stool form was part of the bowel pattern diary, which was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study."|34 days (Visit 6)|Intent-to-treat|||units on a scale||Standard Error|Mean
2725653|NCT01056107|Secondary|Stool Frequency|Stool frequency was self reported in a Bowel Pattern Diary. The bowel pattern diary was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.|screening visit (Visit 1), 34 days (Visit 6)|Intent-to-treat|||Stools/day||Standard Error|Mean
2725654|NCT01056107|Secondary|Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours (Visit 4 = Day 2)|Intent-to-treat|||units on a scale||Standard Error|Mean
2725655|NCT01056107|Secondary|Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy|Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours (Visit 4 = Day 2)|Intent-to-treat|||hours||Standard Error|Mean
2725656|NCT01056107|Secondary|Colonic Filling at 6 h Measured by Scintigraphy|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours (Visit 2 = Day 0)|Intent-to-treat|||percentage of meal||Standard Error|Mean
2725657|NCT01056107|Secondary|Colonic Geometric Center at 4 h Measured by Scintigraphy|"The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (Note: when there is no radio isotope in the colon (e.g., at 4 hours) the geometric center values are recorded as zero, thus the mean values can be less than one.)"|4 hours (Visit 2 = Day 0)|Intent-to-treat|||units on a scale||Standard Error|Mean
2725658|NCT01056107|Secondary|Gastric Residual at 2 and 4 Hours Measured by Scintigraphy|The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).|2 hours, 4 hours (Visit 2 = Day 0)|Intent-to-treat|||proportion of isotope in the stomach||Standard Error|Mean
2725659|NCT01056107|Primary|Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)|Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.|approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)|Intent-to-treat|||minutes||Standard Error|Mean
2725660|NCT01056107|Primary|Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)|"A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the fasting volume and 2 postprandial volumes were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation)."|approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)|Intent-to-treat|||mL||Standard Error|Mean
2725661|NCT01056107|Primary|Colonic Transit, Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours (Visit 3 = Day 1)|Intent-to-treat|||units on a scale||Standard Error|Mean
2725662|NCT01056016|Primary|Physician ADHD Practice Behavior|Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response|Baseline and 6 months|Patient chart reviews were conducted with 174 patients in the ADHD Collaborative Intervention group and 64 patients in the Wait-list control group|||percentage of patients||Standard Deviation|Mean
2725663|NCT01055886|Other Pre-specified|Diary Ratings of Cravings|"Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item Please indicate your desire/craving to smoke, and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be worse because they indicate increased craving, which is likely to lead to non-abstinence."|During pre-quit period; two weeks|61 participants provided this EMA data during the pre-quit period.|||units on a scale||Standard Error|Mean
2725679|NCT01055704|Secondary|Colonic Filling at 6 Hours|Percent of solids reaching the colon at 6 hours|6 hours||||Percentage||Standard Error|Mean
2725665|NCT01055886|Primary|Participants Self-reporting Abstinence During 6 Weeks Post Quit|In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.|6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12|37 participants completed the ecological momentary assessment (EMA; diary) ratings during the post-quit period.|||participants|||Number
2725666|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.|||ng*hr/mL||Standard Deviation|Mean
2725667|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.|||ng/mL||Standard Deviation|Mean
2725668|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.|||ng*h/mL||Standard Deviation|Mean
2725669|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.|||ng/mL||Standard Deviation|Mean
2725670|NCT01055782|Secondary|Perception of Pain|VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale|After endoscopy (within 10mins) and 1 day after endoscopy||||Scores on a scale 0-10||Standard Deviation|Mean
2725671|NCT01055782|Primary|Completed Colonoscopy||immediately after colonoscopy|Choosen by randomization.|||participants|||Number
2725672|NCT01055769|Secondary|Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||hours||Standard Deviation|Mean
2725673|NCT01055769|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The time of the first occurrence of peak concentration observed directly from data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||hours||Full Range|Median
2725674|NCT01055769|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||mcg*h/mL||Standard Deviation|Mean
2725675|NCT01055769|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
2725676|NCT01055769|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||microgram*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
2725677|NCT01055704|Secondary|Stool Consistency as Reported From the Bristol Stool Scale|"Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|Daily||||Units on a scale||Standard Error|Mean
2725678|NCT01055704|Secondary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 13 days.|daily||||Stools||Standard Error|Mean
2725680|NCT01055704|Secondary|Colonic Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours||||Units on a scale||Standard Error|Mean
2725681|NCT01055704|Secondary|Colonic Geometric Center at 4 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|4 hours||||Units on a scale||Standard Error|Mean
2725682|NCT01055704|Secondary|T1/2 of Gastric Emptying of Solid||4 hours||||Minutes||Standard Error|Mean
2725683|NCT01055704|Secondary|T1/2 of Ascending Colon Emptying||24 hours||||hours||Standard Error|Mean
2725684|NCT01055704|Primary|Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours||||Units on a scale||Standard Error|Mean
2725685|NCT01055639|Secondary|Pittsburgh Sleep Quality Index|The 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).|8 weeks||||units on a scale||Standard Deviation|Mean
2725686|NCT01055639|Secondary|PTSD Checklist|The 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).|8 weeks||||units on a scale||Standard Deviation|Mean
2725687|NCT01055639|Secondary|Pain Anxiety Symptom Scale - 20|Anxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken & Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient's activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).|8 weeks||||units on a scale||Standard Deviation|Mean
2725688|NCT01055639|Secondary|Patient Health Questionnaire-9|The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).|8 weeks||||units on a scale||Standard Deviation|Mean
2725689|NCT01055639|Secondary|SF-12 PCS|Physical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks||||units on a scale||Standard Deviation|Mean
2725690|NCT01055639|Secondary|SF-12 MCS|6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks||||units on a scale||Standard Deviation|Mean
2725691|NCT01055639|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|The West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).|8 weeks||||units on a scale||Standard Deviation|Mean
2725692|NCT01055639|Secondary|Brief Pain Inventory-severity Subscale|The Brief Pain Inventory Short Form (BPI; Cleeland & Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).|8 weeks||||units on a scale||Standard Deviation|Mean
2725693|NCT01055639|Primary|Brief Pain Inventory-interference Subscale|The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland & Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).|8 weeks||||units on a scale||Standard Deviation|Mean
2725694|NCT01055613|Primary|Distance Visual Acuity (LogMAR)|Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.|Up to 3 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR|Subject Eyes|Standard Deviation|Mean
2725695|NCT01055613|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.|3 months|The analysis population consists of all subjects that were dispensed a solution during the course of the study.|||Subjects Eyes|Subject Eye's||Number
2725696|NCT01055496|Secondary|Mean Inotuzumab Ozogamicin Serum Concentrations|Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays.|Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.|PK population - included all participants who provided samples for PK analysis.|||ng/mL||Standard Deviation|Mean
2725697|NCT01055496|Primary|Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy|"The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling."|Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.|Safety population|||Percentage of Participants|||Number
2725698|NCT01055496|Primary|Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy|"The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling."|Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.|Safety population|||Percentage of Participants|||Number
2725699|NCT01055496|Primary|Percentage of Participants With a Treatment Emergent AE|An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0).|SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.|Safety population - included all participants who received ≥1 cycle of investigational product|||Percentage of Participants|||Number
2725700|NCT01055496|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts|OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.|6, 12, and 24 Months|ITT population|||Percent Probability||95% Confidence Interval|Number
2725701|NCT01055496|Secondary|Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts|OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.|From first dose of study medication through 2 year follow-up period|ITT population|||Months||95% Confidence Interval|Median
2725702|NCT01055496|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts|OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.|6, 12, and 24 months|ITT population|||Percent Probability||95% Confidence Interval|Number
2725703|NCT01055496|Secondary|Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts|OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.|From first dose of study medication through 2 year follow-up period|ITT population|||Months||95% Confidence Interval|Median
2725723|NCT01055262|Secondary|Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed on the morning of Day X+1 (eg, Day 6). Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Day 2 to Day 6|Safety Population|||Percentage of participants||95% Confidence Interval|Number
2725704|NCT01055496|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.|Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive.|6, 12, and 24 months|ITT population|||Percent Probability||95% Confidence Interval|Number
2725705|NCT01055496|Secondary|Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts|PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose.|From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks|ITT population|||Months||95% Confidence Interval|Median
2725706|NCT01055496|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts|Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive.|6, 12 and 24 months|ITT population|||Percent Probability||95% Confidence Interval|Number
2725707|NCT01055496|Secondary|Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts|PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose.|From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks|ITT population|||Months||95% Confidence Interval|Median
2725708|NCT01055496|Primary|Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts|OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.|Intent-to-Treat (ITT) population: all participants enrolled into the study|||Percentage of participants||95% Confidence Interval|Number
2725709|NCT01055496|Primary|Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2|DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle.|From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.|Safety Analysis Population includes all subjects who received at least 1 cycle of study drug. Analysis population for DLT is participants evaluable for DLT.|||Participants|||Count of Participants
2725721|NCT01055262|Secondary|Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation|"Participants discontinued study due to adverse event (AE) if erythema ≥ 2.0, pain upon touch associated with non-zero erythema score or elevated response on the morning of Day X+1. Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked Does your skin hurt when I touch it?"|Baseline to Day 6|Safety population; N = participants with a non-zero erythema score or elevated response leading to study discontinuation.|||Days||Standard Deviation|Mean
2725710|NCT01055496|Secondary|Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts|OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.|ITT population|||Percentage of participants||95% Confidence Interval|Number
2725711|NCT01055496|Primary|Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1|DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle.|From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.|Safety Analysis Population includes all subjects who received at least 1 cycle of study drug. Analysis population for DLT is participants evaluable for DLT.|||Participants|||Count of Participants
2725712|NCT01055457|Primary|Distance Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.|Up to 3 Months Post Lens Wear|All subjects that completed the study.|||LogMAR|Subjects Eyes|Standard Deviation|Mean
2725713|NCT01055457|Primary|Slit Lamp Findings (SLF)|Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.|Up to 3 months Post Lens Wear|All subjects that completed the study.|||eyes (2 per subject)|Subject eyes||Number
2725714|NCT01055314|Secondary|Response Rate (CR + PR)|Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.|From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities|20 participants were excluded because of ineligibility or absence in overall response evaluation.|||Proportion of Participants||95% Confidence Interval|Number
2725715|NCT01055314|Primary|Event-Free Survival|Probability of no relapse, secondary malignancy, or death after 3 years in the study.|3 years|9 participants who were ineligible or did not receive treatment were excluded.|||Probability||95% Confidence Interval|Number
2725716|NCT01055314|Primary|Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.|Up to 54 weeks|9 participants who were ineligible or did not receive treatment were excluded.|||Participants|||Number
2725717|NCT01055314|Primary|Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment|Proportion of no Grade 4+ non-hematologic toxicity.|From start to week 26 of therapy|13 participants were excluded because of ineligibility or insufficient information to assess feasibility.|||Proportion of Participants||95% Confidence Interval|Number
2725718|NCT01055314|Primary|Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment|Proportion of no Grade 3+ cardiac toxicity.|From start to week 26 of therapy|18 participants were excluded because of ineligibility or insufficient information to assess feasibility.|||Proportion of Participants||95% Confidence Interval|Number
2725719|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day|Skin assessments performed after 4 hours of wear, participants discontinued wrap wear for remainder of day (4 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Erythema grading scale: 7 point scale ranging from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda and follicular response.|Baseline to Day 6|Safety Population|||Percentage of participants|||Number
2725720|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day|Skin assessments performed prior to heatwrap application; participant discontinued wrap wear for day (8 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Outcome included those who discontinued wrap wear by 4 hours on same day. Erythema grading scale: 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response.|Baseline to Day 6|Safety Population|||Percentage of participants|||Number
2725722|NCT01055262|Secondary|Time to First Report of Non-zero Erythema Score or Elevated Response|Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Baseline to Day 6|Safety population; N = participants with any application site finding|||Days||Standard Deviation|Mean
2725724|NCT01055262|Secondary|Time to First Significant Skin Event|"Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked Does your skin hurt when I touch it?"|Baseline to Day 6|Safety population; Number of participants analyzed (N) = number of participants with significant skin event.|||Days||Standard Deviation|Mean
2725725|NCT01055262|Secondary|Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)|"Events associated with Day X wear (eg, Day 4) assessed on the morning of Day X+1 (eg, Day 5). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked Does your skin hurt when I touch it?"|Day 2 to Day 5|Safety population|||Percentage of participants||95% Confidence Interval|Number
2725726|NCT01055262|Primary|Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)|"Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter [cm] diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked Does your skin hurt when I touch it?"|Day 2 to Day 6|Safety population: participants who wore the product at least once during the study|||Percentage of participants||95% Confidence Interval|Number
2725727|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
2725728|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
2725729|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
2725730|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
2725741|NCT01055171|Primary|Test Session Distress Scores (Session 2)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during test session (Session 2)||||units on a scale||Standard Error|Mean
2725731|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
2725732|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008|Type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.|||fractures|||Number
2725733|NCT01055197|Secondary|Percentage of Planned Radiotherapy Dose (All Sites) That Was Delivered|Total dose to the brain was to be 25 Gy for all patients. For patients on PCI+consolidative RT, patients were to get 45 Gy at 3 Gy per fraction to the locoregional area as well as to residual metastatic disease. Alternatively, these regions could have received 30-40 Gy in 10 fractions. The total planned dose was determined, and a percentage was calculated based for each patient as total delivered dose / total planned dose.|From start to end of radiation therapy; up to 32 days for Prophylactic Cranial Irradiation arm, up to 68 days for Prophylactic Cranial Irradiation + Consolidation Radiotherapy arm.|All eligible patients who started study treatment|||percentage of planned dose delivered||Full Range|Median
2725734|NCT01055197|Secondary|First Failure (12-month Rate Reported)|Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging [per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1] and physical examination. Time to first failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death (competing risk). First failure rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.|All eligible patients|||percentage of participants||95% Confidence Interval|Number
2725735|NCT01055197|Secondary|Patterns of Failure - Number of Patients With Failure by Site|Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging [per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1] and physical examination. A patient could be counted in more than one category.|From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.|All eligible patients who had a failure|||Participants|||Count of Participants
2725736|NCT01055197|Secondary|Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event|Adverse events (AE) are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2725737|NCT01055197|Primary|Overall Survival (12-month Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months. The 12-month rate is reported.|From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2725738|NCT01055184|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|day 0 to day 7 post vaccination||||participants|||Number
2725739|NCT01055171|Secondary|Proportion of Drinking Days|Proportion of drinking days from 90 days prior to the screening to the follow-up period.|90 days prior to participation in study up to 2-week follow up session (Session 3)||||Drinking days||Standard Error|Mean
2725740|NCT01055171|Primary|Test Session Craving Scores (Session 2)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during test session (Session 2)||||units on a scale||Standard Error|Mean
2725742|NCT01055171|Primary|Retrieval Session Craving Scores (Session 1)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during retrieval session (Session 1)||||units on a scale||Standard Error|Mean
2725743|NCT01055171|Primary|Retrieval Session Distress Scores (Session 1)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during retrieval session (Session 1)||||units on a scale||Standard Error|Mean
2725744|NCT01055132|Primary|Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||units on a scale||Standard Deviation|Mean
2725745|NCT01055132|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||units on a scale||Standard Deviation|Mean
2725746|NCT01055132|Primary|Binocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||LogMAR||Standard Deviation|Mean
2725747|NCT01055132|Primary|Monocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||logMAR||Standard Deviation|Mean
2725748|NCT01055028|Secondary|Overall Survival (OS) at 12 Months|Assessed as the number of subjects known to remain alive 12 months after study entry|12 months||||Participants|||Count of Participants
2725749|NCT01055028|Secondary|Overall Survival (OS) at 6 Months|Assessed as the number of subjects known to remain alive 6 months after study entry|6 months||||Participants|||Count of Participants
2725750|NCT01055028|Secondary|Overall Response Rate After 6th Cycle|"Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects.~RECIST Criteria~CR = Disappearance of all target lesions~PR = ≥ 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s),~Stable disease (SD) = Small changes that do not meet any of the above criteria"|6 Cycles|Includes participants that complete 6 cycles of treatment|||Participants|||Count of Participants
2725751|NCT01055028|Secondary|Overall Response Rate After 3 Cycles|"Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects.~RECIST Criteria~CR = Disappearance of all target lesions~PR = ≥ 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s),~Stable disease (SD) = Small changes that do not meet any of the above criteria"|12 weeks|Includes participants that complete 3 cycles of treatment|||Participants|||Count of Participants
2725752|NCT01055028|Primary|Progression-free Survival (PFS)|"The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment.~Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s)."|4 months|Includes all subjects that started treatment|||Participants without disease progression|||Number
2726150|NCT01051349|Secondary|Number of Participants With Antibodies to DAC HYP||Up to Week 288|Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here number of participants analyzed is the participants who were evaluated for this outcome measure.|||Participants|||Count of Participants
2725753|NCT01054976|Secondary|Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)|The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.|Baseline, Week 12|Intention-to-Treat analysis set.|||scores on a scale||Standard Deviation|Mean
2725754|NCT01054976|Secondary|Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)|"DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on not applicable (x) which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function"|Baseline, Week 12|Intention-to-Treat analysis set.|||scores on a scale||Standard Deviation|Mean
2725755|NCT01054976|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.|Baseline, Week 12|Intention-to-Treat analysis set.|||scores on a scale||Standard Deviation|Mean
2725756|NCT01054976|Primary|Change From Baseline in Choice Reaction Time|The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.|Baseline, Week 12|Per-protocol (PP) analysis set.|||seconds||Standard Deviation|Mean
2725757|NCT01054976|Primary|Change From Baseline in Simple Reaction Time|The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.|Baseline, Week 12|Per-protocol (PP) analysis set.|||seconds||Standard Deviation|Mean
2725758|NCT01054911|Secondary|Alteration in Diffusion and Vascularity Kinetics|The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.|MRI at baseline, Week 2 and Week 6|Data were not collected||||||
2725759|NCT01054911|Secondary|Measurable Disease Response Rate|Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed|FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12|Data were not collected.||||||
2725760|NCT01054911|Primary|Number of Participants With Adverse Events||6 months||||participants|||Number
2725761|NCT01054885|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
2725762|NCT01054885|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.|||Liters||Standard Error|Least Squares Mean
2725773|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.|||percent||Standard Deviation|Mean
2725787|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 27|The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
2725763|NCT01054885|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Scores on a scale||Standard Error|Least Squares Mean
2725764|NCT01054885|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
2725765|NCT01054885|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
2725766|NCT01054846|Secondary|Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners|Number of injuries by helmet wearing status as reported|5 months|Analysis population includes all participants that owned a helmet and available data for this assessment|||Injuries|||Number
2725767|NCT01054846|Primary|Percentage of Participants Wearing Helmet||Baseline (Survey 1) and 5 months (Survey 2)|Analysis reflect population that owned the helmet during each survey|||Percentage of Participants|||Number
2725768|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator|Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.|||participants|||Number
2725769|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant|Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.|||participants|||Number
2725770|NCT01054820|Secondary|Mean Change From Baseline to EOT in Beck Depression Inventory® Il|The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and >40=extreme depression.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; End-of-Treatment score was the most recent non-missing value.|||scores on a scale||Standard Deviation|Mean
2725771|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator|Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population|||participants|||Number
2725772|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant|Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population|||participants|||Number
2725774|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
2725775|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
2725776|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
2725777|NCT01054820|Secondary|Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.|||participants|||Number
2725778|NCT01054820|Primary|Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
2725779|NCT01054742|Primary|Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study|A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.|From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1, Part 2 of the study, and who consented to retreatment.|||participants|||Number
2725780|NCT01054729|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir||Baseline to Week 4|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.|||percentage of participants|||Number
2725781|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27|The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
2725782|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0|The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
2725783|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 27|The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
2725784|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 0|The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
2725785|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27|The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
2725786|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0|The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
2725788|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 0|The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
2725789|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27|"The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).~AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
2725790|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0|"The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).~AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
2725791|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27|The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
2725792|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0|"The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.~Cmax is defined as the maximum concentration of drug."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
2725793|NCT01054729|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment|SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).|Post-treatment Weeks 12 and 24|Safety Analysis Set|||percentage of participants|||Number
2725794|NCT01054729|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.|Week 4|Safety Analysis Set|||percentage of participants|||Number
2725795|NCT01054729|Secondary|Change in Circulating HCV RNA at Week 4||Baseline to Week 4|Safety Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2725796|NCT01054729|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 4|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2725797|NCT01054703|Secondary|Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures||1 wk, 2wk, 4wk, 6wk|||||||
2725798|NCT01054703|Primary|Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant||Procedural and 6 weeks post-implant||||participants|||Number
2725799|NCT01054625|Secondary|Apparent Volume of Distribution at Steady State||8 weeks||||L||Geometric Coefficient of Variation|Geometric Mean
2725800|NCT01054625|Secondary|Apparent Volume of Distribution During the Terminal Phase||8 weeks||||L||Geometric Coefficient of Variation|Geometric Mean
2725801|NCT01054625|Secondary|Clearance||8 weeks||||L/h||Geometric Coefficient of Variation|Geometric Mean
2725802|NCT01054625|Secondary|Elimination Half-life||8 weeks||||h||Geometric Coefficient of Variation|Geometric Mean
2725803|NCT01054625|Secondary|Area Under Curve 0-21 Days||0-21 days||||h mg/L||Geometric Coefficient of Variation|Geometric Mean
2725804|NCT01054625|Secondary|Area Under Curve 0-7 Days||0-7 days||||h mg/L||Geometric Coefficient of Variation|Geometric Mean
2725805|NCT01054625|Primary|Maximum Plasma Concentration of Zalutumumab After Fourth Infusion|PK samples are taken: pre and post infusion on days 0, 14, 21 and 28 plus at +3 and +12 hours on days 0 and 28. A single PK sample is taken on days between these treatments and 8 more are taken over 3 weeks after treatment on day 28.|Pre and post infusion after weekly administration of zalutumumab during 28 days||||mg/L||Geometric Coefficient of Variation|Geometric Mean
2725806|NCT01054599|Secondary|A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.|SRT-CLTR (range 0-72; higher scores indicate better memory), and 7-24 Spatial Memory Test (range 0-35; scores are summed across the 5 learning trials, with higher scores indicating better memory) scores will be assessed across the first (baseline) and third (post-open label memantine) testing sessions. These measures are considered to be scores on a scale, rather than standard units. The hypothesis was that subjects randomized to memantine would demonstrate sustained improvement from baseline, while the placebo group would demonstrate improvements after taking open label memantine (compared to baseline).|26 weeks|This analysis included only those subjects who participated in the open label extension period.|||scores on a scale||Standard Deviation|Mean
2725807|NCT01054599|Secondary|To Test the Hypothesis That Treatment With Memantine Will Result in Subjective Improvement of Memory Function, the Change Scores From the QOLIE-89 Will be Evaluated.||5 years||2017-12-31|12/2017||||
2725808|NCT01054599|Secondary|To Test the Hypothesis That Improvement Will be Selective for Verbal Memory, Change Scores on the Non-verbal Tasks Will be Compared Between the Placebo and Memantine Treatment Groups.||5 years||2017-12-31|12/2017||||
2725866|NCT01054300|Primary|24-hour Weighted Mean Plasma Glucose|Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.|Up to 24 hours|Analysis population included randomized participants who received study drug and had mean plasma glucose measurements during all of the specific collection time frames.|||mg/dL||Standard Deviation|Mean
2725809|NCT01054599|Primary|The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.|Change scores from pre- to post-treatment/placebo were calculated for the primary outcome measures, the Selective Reminding Test Continuous Long-Term Retrieval (range 0-72; higher scores indicate better memory) and 7-24 Spatial Recall Test Total Learning (range 0-35; total correct across 5 learning trials are summed, with higher scores indicating better memory) scores. These measures are scores on a scale, rather than representing standard units.|13 weeks|The analysis includes subjects who completed both sessions 1 (baseline) and 2 (post-treatment/placebo). One subject in the memantine group completed both sessions, but the data were excluded from analysis due to seizures occurring during testing sessions 1 and 2, yielding n=8 in the memantine group.|||scores on a scale||Standard Deviation|Mean
2725810|NCT01054586|Other Pre-specified|Median Bilirubin Level at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||milligrams (mg)/deciliter (dl)||Full Range|Median
2725811|NCT01054586|Other Pre-specified|Median Blood Platelet Count at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||10^9/liter||Full Range|Median
2725812|NCT01054586|Secondary|Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures|Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population.|Incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||incidence rate|||Number
2725813|NCT01054586|Secondary|Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only|Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available)|The incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||participants|||Number
2725814|NCT01054586|Secondary|Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen|Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||participants|||Number
2725815|NCT01054586|Secondary|Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r|Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||participants|||Number
2725816|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events|Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available).|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725817|NCT01054586|Secondary|Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only|Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725818|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725819|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725820|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725821|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725822|NCT01054586|Other Pre-specified|Median ALT and AST Scores at Baseline|Participants characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||IU/L (International Units per Liter)||Full Range|Median
2725837|NCT01054573|Secondary|Percentage of Participants Who Relapsed During Follow-Up|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)|The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.|||Percentage of participants|||Number
2725823|NCT01054586|Other Pre-specified|Median Model of End-stage Liver Disease (MELD) Score at Baseline|MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30-39, 83% mortality; 20-29, 76% mortality; 10-19, 27% mortality.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe. MELD scores are not available for the “FPV 700 mg BID/RTV 100 mg QD” group due to missing data.|||MELD score||Full Range|Median
2725824|NCT01054586|Other Pre-specified|Median FIB (a Model of End-stage Liver Disease) Score at Baseline|The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis).|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||FIB Score||Full Range|Median
2725825|NCT01054586|Other Pre-specified|Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline|The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||APRI Score||Full Range|Median
2725826|NCT01054586|Other Pre-specified|Cluster of Differentiation (CD4) Count at Baseline|Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||cells/microliter (μl)||Full Range|Median
2725827|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725828|NCT01054586|Other Pre-specified|Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline|Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||years||Full Range|Median
2725829|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725830|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725831|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725832|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725833|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725834|NCT01054586|Primary|Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
2725835|NCT01054573|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||log 10 IU/ml||Full Range|Median
2725836|NCT01054573|Secondary|Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time|The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Log 10 IU/mL||Full Range|Median
2725852|NCT01054560|Secondary|Time to Initial Recanalization|Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow|post treatment|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size|||minutes||Standard Deviation|Mean
2725838|NCT01054573|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.|Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2725839|NCT01054573|Secondary|Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).|Weeks 4 and 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2725840|NCT01054573|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2725841|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36|The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.|Week 12 or Weeks 24 or 36|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2725842|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8|The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.|Week 4, Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2725843|NCT01054573|Secondary|The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.|Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants with response|||Number
2725844|NCT01054573|Primary|The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)|The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.|End of trial (24 weeks after last dose, administerd at 48 weeks)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants with response|||Number
2725845|NCT01054560|Primary|Procedure-related Serious Adverse Events (SAEs)|Incidence of study procedure-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat|||percentage of subjects|||Number
2725846|NCT01054560|Primary|Study Device-related Serious Adverse Events (SAEs)|Incidence of study device-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat|||percentage of subjects|||Number
2725847|NCT01054560|Secondary|Non-fatal Stroke-related Morbidity|Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events|90 Day|Intent-to-treat|||percentage of subjects|||Number
2725848|NCT01054560|Secondary|Symptomatic Intracranial Hemorrhage|Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.|24 hours|Intent to treat|||Percentage of subjects|||Number
2725849|NCT01054560|Secondary|Mortality|Rate of Mortality|90 Days follow-up|Intent-to-treat|||Percentage of subjects|||Number
2725850|NCT01054560|Secondary|Good Neurological Outcome 90 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|90 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Percent of subjects|||Number
2725851|NCT01054560|Secondary|Good Neurological Outcome at 30 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|30 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Percent of subjects|||Number
2725853|NCT01054560|Primary|Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage|"Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.~Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.~TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)"|Immediately post treatment|Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.|||Percent of Subjects|||Number
2725854|NCT01054404|Primary|Acceptable vs. Unacceptable Brain Relaxation at Dural Opening|"Rating of brain relaxation will be on a 4-point scale:~0 = brain very relaxed under dura, acceptable~= brain adequately relaxed under dura, acceptable~= brain slightly tense under dura, acceptable~= brain very tense under bulging dura, unacceptable"|just prior to dural opening for each subject||||units on a scale 0-3||Standard Error|Mean
2725855|NCT01054339|Secondary|Changes in Serum Total Alpha-1 Antitrypsin Concentrations|Results are the mean ± SD for pre-treatment (Screening and Baseline) and Months 6-12 data and mean ± SE for the difference between the pre-treatment and months 6-12 means for 3 subjects per group.|During months 6-12 after study agent adminstration|Analysis based on all subjects enrolled in study.|||micromolar||Standard Error|Mean
2725856|NCT01054339|Secondary|Changes in Serum M-specific Alpha-1 Antitrypsin Concentration|Results are the mean ± SD for pre-treatment (Screening and Baseline) and Months 6-12 values and mean ± SE for the difference between the pre-treatment and months 6-12 means for 2 subjects in the low dose group and 3 subjects in each of the other two groups. The monoclonal antibody used to determine serum M-specific AAT concentrations has very little cross-reactivity with Z type AAT but cross-reacts strongly with S type AAT, causing results for this assay to be spuriously high for subject 303 in the low dose group.|During months 6-12 after study agent adminsitration|One subject in low dose group had AAT phenotype SZ, which made measurement of M-specific serum alpha-1 antitrypsin concentration invalid.|||nanomolar||Standard Error|Mean
2725857|NCT01054339|Primary|Frequency of Grade 3 or 4 Adverse Events||During 1 year after study agent administration|Analysis based on all subjects enrolled in study.|||participants|||Number
2725858|NCT01054300|Primary|Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin|PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.|0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose|All participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hours||Full Range|Median
2725859|NCT01054300|Primary|Maximum Plasma Concentration (Cmax) of Ertugliflozin|PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.|0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose|All participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2725860|NCT01054300|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin|Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.|0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose|All participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2725861|NCT01054300|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.|Up to 8 days (Day 1 in each dosing period)|Analysis population includes all treated participants.|||Participants|||Count of Participants
2725862|NCT01054300|Primary|Number of Participants Experiencing an Adverse Event|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug.|Up to 16 days|Analysis population includes all treated participants.|||Participants|||Count of Participants
2725863|NCT01054300|Primary|Fasting C-peptide|The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.|Up to 24 hours (0 and 24 hours)|Analysis population included randomized participants who received assigned dose and had fasting c-peptide measurements during the specific time frame.|||ng/mL||90% Confidence Interval|Least Squares Mean
2725864|NCT01054300|Primary|Fasting Plasma Glucose|Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours. Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose. As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately.|Up to 24 hours|The protocol listed fasting plasma glucose as one of the endpoints of the study. However, given the assessment of weighted mean 24-hour plasma glucose and weighted mean postprandial glucose following the 3 meals on Day 1 of each period, analysis of fasting plasma glucose was not undertaken.||||||
2725865|NCT01054300|Primary|Weighted Mean Postprandial Plasma Glucose|The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.|At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)|Analysis population included randomized participants who received assigned dose and had postprandial plasma glucose measurements during the specific time frame.|||mg/dL||Standard Deviation|Mean
2726030|NCT01052480|Secondary|Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women|Incidence of spontaneous abortion or stillborn fetus for pregnant female participants|Measured from Day 0 through Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2725867|NCT01054300|Primary|Urinary Glucose Excretion by Time Period|Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.|At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)|Analysis population included randomized participants who received assigned dose and had urine collection during the specific time frame.|||Grams||Standard Deviation|Mean
2725868|NCT01054300|Primary|Cumulative Urinary Glucose Excretion Over 0 to 24 Hours|Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.|0 to 24 hours after the morning dose|Analysis population included randomized participants who received assigned dose and had urine collection during all of the collection time frames between 0 and 24 hours following the morning dose.|||Grams||90% Confidence Interval|Least Squares Mean
2725869|NCT01054222|Secondary|King's Health Questionnaire (KHQ) Domain Scores|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.|Baseline, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2725870|NCT01054222|Secondary|Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)|"OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication's ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as 'very satisfied', 'somewhat satisfied', 'neither dissatisfied nor satisfied', 'somewhat dissatisfied', and 'very dissatisfied'. The results for Q9 to 11 are reported as satisfied (participants who answered 'very satisfied' or 'somewhat satisfied' for all 7 questions) or not satisfied (participants who answered 'neither dissatisfied nor satisfied' or 'somewhat dissatisfied' or 'very dissatisfied' for all 7 questions)."|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||participants|||Number
2725871|NCT01054222|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2725872|NCT01054222|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2725873|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment|PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||Participants|||Number
2725986|NCT01053078|Secondary|Hypoglycemia Symptom Score|Hypoglycemia symptom score is determined by a standardized 12-item questionnaire. Participants rank hypoglycemic symptoms on a Likert scale from 0 (no symptoms) to 6 (severe symptoms). Total score is a sum of the 12 items scores with a total score range from 0 to 72. Higher scores indicated increased severity of symptoms associated with hypoglycemia.|1 month||||score on a scale||Standard Deviation|Mean
2725874|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||Participants|||Number
2725875|NCT01054222|Secondary|Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours|The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.|||Units per 24 hours||Standard Deviation|Mean
2725876|NCT01054222|Secondary|Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.|||Percentage of Participants|||Number
2725877|NCT01054222|Secondary|Percentage of Incontinent Participants at Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary.|||Percentage of Participants|||Number
2725878|NCT01054222|Secondary|Daily Sum Rating on the Urinary Sensation Scale (USS)|The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Numerical decrease indicates improvement.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||Units on a Scale||Standard Deviation|Mean
2725879|NCT01054222|Secondary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2725880|NCT01054222|Secondary|Mean Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||micturitions per 24 hours||Standard Deviation|Mean
2725881|NCT01054222|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||micturitions per 24 hours||Standard Deviation|Mean
2725899|NCT01054170|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
2725882|NCT01054222|Secondary|Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours|The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2725883|NCT01054222|Secondary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2725884|NCT01054222|Primary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|End of Treatment (up to Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
2725885|NCT01054209|Secondary|Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed)||From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs|||||||
2725886|NCT01054209|Secondary|Differences in Length of Hospital Stay||Worked out reterospectively post-discharge from hospital patient notes|||||||
2725887|NCT01054209|Secondary|Differences in Time Taken for Mother to Become Fit for Discharge From Recovery||Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure|||||||
2725888|NCT01054209|Secondary|Differences in Immediate Health of Baby||At time of baby's birth - same day as Caesarean section|||||||
2725889|NCT01054209|Secondary|Differences in Shivering (Severity and the Need for Treatment)||On admission to recovery room - time variable, same day as procedure|||||||
2725890|NCT01054209|Secondary|Differences in Wound Infection Rates||From immediately post-operative till 1 month post procedure|||||||
2725891|NCT01054209|Secondary|Differences in Incidence of Blood Transfusion||From start of Caesarean section to discharge from hospital - times variable|||||||
2725892|NCT01054209|Secondary|Differences in Total Blood Loss||At the end of the Caesarean section - time variable|||||||
2725893|NCT01054209|Primary|This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce the Incidence of Shivering in Patients Undergoing Planned Caesarean Section.|Shivering described according to severity on a scale of 1-4|From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure||2020-03-31|03/2020||||
2725894|NCT01054209|Primary|This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce Post-operative Hypothermia (Defined as Body Temperature of Less Than 36.0ºC) in Patients Undergoing Planned Caesarean Section.|IPH (body temperature of less than 36.0ºC)|On admission to recovery room - time variable, same day as procedure||||participants||95% Confidence Interval|Number
2725895|NCT01054183|Primary|Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).|Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).|30 days; no long-term outcome measures were included|The study was powered for 62 patients per study arm. Due to slow patient enrollment, the study was stopped prior to full enrollment with the aforementioned 22 total patients.|||Percent of successful intubations|Participants||Number
2725896|NCT01054183|Primary|Percent of Participants With Successful 1st Intubation Attempt|Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)|30 days||||Percent of Participants|||Number
2725897|NCT01054170|Secondary|Exacerbations|Number of patients experiencing disease exacerbations on treatment.|Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Participants|||Number
2725898|NCT01054170|Secondary|Percentage of Reliever Free Days in Last Six Weeks of Treatment|Percentage of reliever free days in last 6 weeks on treatment.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||percentage of days||Standard Error|Least Squares Mean
2725941|NCT01053819|Primary|The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.||Patients will complete study within 6 months.|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.|||participants|||Number
2725987|NCT01053078|Primary|Cerebral Blood Flow||1 month||||percentage of signal intensity change||Standard Deviation|Mean
2725900|NCT01054170|Secondary|EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Total Score||Standard Error|Least Squares Mean
2725901|NCT01054170|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Total Score||Standard Error|Least Squares Mean
2725902|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725903|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725904|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Evening (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2725905|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Morning (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2725906|NCT01054170|Secondary|Post-bronchodilator Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725907|NCT01054170|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725908|NCT01054170|Secondary|Post-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725909|NCT01054170|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725910|NCT01054170|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725911|NCT01054170|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725912|NCT01054170|Secondary|Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)|Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||mmol/kPa*min||Standard Error|Least Squares Mean
2725913|NCT01054170|Secondary|Pre-bronchodilator Specific Airway Conductance (SGaw)|Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||1/[s*kPa]||Standard Error|Least Squares Mean
2725914|NCT01054170|Secondary|Pre-bronchodilator Residual Volume (RV)|Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725915|NCT01054170|Secondary|Pre-bronchodilator Functional Residual Capacity (FRC)|Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725916|NCT01054170|Secondary|Pre-bronchodilator Total Lung Capacity (TLC)|Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725917|NCT01054170|Secondary|Pre-bronchodilator Inspiratory Capacity (IC)|Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2725918|NCT01054170|Secondary|Air Trapping Index (ATI) on Expiratory Scans|ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ATI Percentage||Standard Error|Least Squares Mean
2725919|NCT01054170|Secondary|5th Generation Wall Area Percentage|5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Percentage Area||Standard Error|Least Squares Mean
2725920|NCT01054170|Primary|AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)|AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||mm||Standard Error|Least Squares Mean
2725921|NCT01054079|Secondary|Change in Total and Free Testosterone|The detectable difference is estimated using a paired t-test approach. The lab measure will also be analyzed longitudinally using all measures with a mixed model approach adjusting for individual covariates.|Up to 20 weeks|No data collected||||||
2725922|NCT01054079|Secondary|Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score. All subscale items are summed to a total. The score range is 0-156. Higher scores represent better quality of life.|up to 20 weeks||||units on a scale||Standard Error|Mean
2725988|NCT01053000|Primary|Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.||12 weeks||||lesions||Standard Deviation|Mean
2725923|NCT01054079|Secondary|Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)|The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Epic produces two scores, one for function (5 items) and the other for bother (6 items). The response for each item is standardized to a 0 to 100 scale. For both scales, higher scores indicate worse outcomes.|up to 20 weeks||||units on a scale||Standard Error|Mean
2725924|NCT01054079|Secondary|Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory|The Brief Male Sexual Inventory is an 11 question assessment including subscales: sex drive, erections, ejaculation. The scores are totaled to produce an overall score with a range of 1-45, with higher score indicating worse outcomes.|Up to 20 weeks||||units on a scale||Standard Error|Mean
2725925|NCT01054079|Primary|Rate of Rise of Serum PSA|The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant's post PSA level.|24 weeks||||Nanograms Per Milliliter||Inter-Quartile Range|Median
2725926|NCT01053988|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
2725927|NCT01053988|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.|||Liters||Standard Error|Least Squares Mean
2725928|NCT01053988|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Scores on a scale||Standard Error|Least Squares Mean
2725929|NCT01053988|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
2725942|NCT01053741|Primary|Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention.|"Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.~Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention."|One hour||||units on a scale||Inter-Quartile Range|Median
2725930|NCT01053988|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
2725931|NCT01053962|Secondary|Changes From Baseline Overall in Ease of Passage (Straining)|Using a Daily Diary, patients recorded Ease of Passage (Straining) using the 7-point Ease-of-Passage Scale (1 = manual disimpaction/enema needed, 2 = severe straining, 3 = moderate straining, 4 = mild straining, 5 = no straining, 6 = urgency, 7 = incontinent). Changes in overall ease of passage (Straining) were assessed from the average 14-day pretreatment baseline to average during the 2-week treatment period|Study Days 1 through 14|Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment. One participant in the SP-304 0.3 mg group did not have post-baseline results.|||units on a scale||Standard Deviation|Mean
2725932|NCT01053962|Secondary|Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)|Using a Daily Diary, patients recorded Stool Consistency using the 7-point Bristol Stool Form Scale (BSFS) (1 = separate hard lumps, like nuts; 2 sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces, entirely liquid). Changes in mean BSFS were assessed from the average 14-day pretreatment baseline to the average during the 2-week treatment period.|Study day 1 through 14|Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment. One participant in the SP-304 0.3 mg group did not have post-baseline results.|||units on a scale||Standard Deviation|Mean
2725933|NCT01053962|Secondary|Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)|Using a Daily Diary, patients recorded the number of spontaneous bowel movements (SBM). The overall weekly frequency was calculated as the total number of SBMs divided by 2 (the number weeks of treatment). Change was calculated as the difference between the number of the SBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.|Study Days 1 through 14|Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment.|||SBMs per week||Standard Deviation|Mean
2725934|NCT01053962|Secondary|Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)|Using a Daily Diary, patients recorded the number of spontaneous bowel movements having the sensation of complete evacuation (Complete Spontaneous Bowel Movement - CSBM). The total number of spontaneous bowel movements associated with a feeling of complete evacuation were summed and divided by 2 (the number of weeks in treatment). Change was calculated as the difference between the number of the CSBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.|Study days 1 through 14|Modified-Intent-to-Treat population: All patients who received at least one dose of study medication and had at least one post-baseline diary assessment. One participant in the SP-304 0.3 mg group did not have information about complete evacuation post-baseline.|||CSBMs per week||Standard Deviation|Mean
2725935|NCT01053962|Primary|Number of Participants With Adverse Events|Incidences of adverse events from Baseline through the end of the Follow-up period.|21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)|Safety Population: all patients who received at least one dose of the study medication.|||Participants|||Count of Participants
2725936|NCT01053897|Secondary|Manchester Scar Scale (MSS)|"Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales.~MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions.~Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4).~Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4).~Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4).~Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)||||units on a scale||Standard Deviation|Mean
2725937|NCT01053897|Secondary|Patient Observer Scar Assessment Scale (POSAS)|"Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse).~Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)|All subjects were included|||units on a scale||Standard Deviation|Mean
2725938|NCT01053897|Secondary|Overall Scar Preference|Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.|12 Month (End of Study)|All Subjects included.|||participants|||Number
2725939|NCT01053897|Primary|Photography- Independent Scar Assessment Panel|An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.|0.5, 1, 2, 3, 6, 9 and 12 Months|All subjects had scar photography completed at study visits. However, due to the early termination of this trial, the independent panel review was not completed.||||||
2725940|NCT01053819|Secondary|A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.|Patients will complete the study within 6 months|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
2725944|NCT01053663|Secondary|Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either ≥5 times change in the NAI IC50 visit value from the Reference value at a visit or ≥5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Days 1, 3, 4, 6, 15|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.|||participants|||Number
2725945|NCT01053663|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
2725946|NCT01053663|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2725947|NCT01053663|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
2725948|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2725949|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2725950|NCT01053663|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2725951|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2725952|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2725953|NCT01053663|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.|||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2725954|NCT01053507|Secondary|Migraine Specific Quality of Life Questionnaire (MSQ)||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
2725955|NCT01053507|Secondary|Headache Impact Test-6 (HIT-6) Score||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
2725956|NCT01053507|Secondary|Mental Efficiency Workload Test (MEWT) Performance Index||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
2725957|NCT01053507|Primary|Associated Headache Symptoms|Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
2725958|NCT01053507|Primary|Headache Days|Change in number of headache days at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
2725959|NCT01053429|Other Pre-specified|Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement|DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicates a positive subjective response (compliant); a negative score indicates non-compliance.|Baseline up to Week 8|Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study.|||participants|||Number
2725989|NCT01052948|Primary|Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up|All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
2725990|NCT01052948|Primary|Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up|Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
2725960|NCT01053429|Other Pre-specified|Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline up to Week 8|Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study.|||particpants|||Number
2725961|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).|||participants|||Number
2725962|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).|||participants|||Number
2725963|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).|||participants|||Number
2725964|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).|||particpants|||Number
2725965|NCT01053312|Secondary|Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.|Post-contrast Administration|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.|||Percentage of Plaque|||Number
2725966|NCT01053312|Primary|Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.|This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.|Post-contrast administration||||Percent plaque area|||Number
2725967|NCT01053312|Primary|Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.|Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.|Post-contrast administration||||Standard Uptake Value Ratio (SUVR)|||Number
2725968|NCT01053247|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).||2 weeks|||||||
2725969|NCT01053247|Primary|Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment||2 weeks||||participants|||Number
2725970|NCT01053221|Secondary|Trans-vivo Delayed Type Hypersensitivity (DTH) Assay|Delayed type hypersensitivity (DTH) reactivity status to donor and minor antigens will be detected using trans-vivo DTH assay. This information will help determine if T-regulatory cells are present, and whether such cells predict outcome of Calcineurin inhibitor withdrawal.|36 months|The study was closed prematurely. Data were not collected||||||
2725971|NCT01053221|Secondary|Patient Survival|patient survival|36 months|The study was closed prematurely. Data were not collected||||||
2725972|NCT01053221|Secondary|Number of Incidences of Infection and Malignancy|Number of incidences of infection and malignancy will be reported.|36 months|The study was closed prematurely. No data was collected||||||
2725973|NCT01053221|Secondary|Renal Function Measured by Serum Creatinine and eGFR||36 months|The study was closed prematurely. No data was collected||||||
2725974|NCT01053221|Primary|Incidence of Kidney Allograft Rejection and Graft Loss||36 months|The study was closed prematurely. Data were not collected||||||
2725975|NCT01053156|Secondary|VAS Categorized by Behavior: Other|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with other behaviors that were not able to be categorized."|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors not falling into the other categories were placed into this category. As not every caregiver named a behavior unrelated to the other categories, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
2725976|NCT01053156|Secondary|VAS Categorized by Behavior:Language/ Cognition|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms."|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding language or cognition symptoms were placed into this category. As not every caregiver named a behavior related to language or cognition, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
2725977|NCT01053156|Secondary|VAS Categorized by Behavior:Anxiety/ Mood|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors."|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding anxiety or mood symptoms were placed into this category. As not every caregiver named a behavior related to anxiety or mood, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
2725978|NCT01053156|Secondary|VAS Categorized by Behavior: Aggression/ ADHD|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors."|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding ADHD or Aggression symptoms were placed into this category. As not every caregiver named a behavior related to ADHD or aggression, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
2725979|NCT01053156|Secondary|Visual Analogue Scale Behavior 3- VAS3|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three."|Baseline, 3 months, 6 months|This behavior was not provided by all of the participating caregivers, and so the number is less than the participants analyzed for other measures.|||units on a scale||Standard Error|Least Squares Mean
2725980|NCT01053156|Secondary|Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score|The ABC-C composite scores were used to quantify the severity of a patient's behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement.|Baseline, 3 months, and 6 months||||units on a scale||Standard Error|Least Squares Mean
2725981|NCT01053156|Secondary|Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score|The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.|Baseline, 3 months, and 6 months||||units on a scale||Standard Error|Least Squares Mean
2725982|NCT01053156|Secondary|Expressive Vocabulary Test-2|The EVT-2 standard score assesses language development through a participant's one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome.|Baseline, 3 months and 6 months||||units on a scale||Standard Error|Least Squares Mean
2725983|NCT01053156|Secondary|Visual Analogue Scale- Behaviors 2|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Least Squares Mean
2725984|NCT01053156|Primary|Visual Analogue Scale- Behavior 1|"A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from worst behavior to behavior not a problem. Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three."|Baseline, 3 months, 6 months|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis|||units on a scale||Standard Error|Least Squares Mean
2725985|NCT01053156|Primary|Clinical Global Impression Scale (CGI)|"The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 very much improved to 7 very much worse. Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner."|3 months (post first treatment) and 6 months (post second treatment)|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis|||units on a scale||Standard Error|Least Squares Mean
2725991|NCT01052948|Primary|Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up|Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
2725992|NCT01052948|Primary|Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up|Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
2725993|NCT01052844|Primary|Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy|6 days||||participants|||Number
2725994|NCT01052844|Primary|Number of Patients With Complete Response During Chemotherapy Course 1|The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)|5 days||||participants|||Number
2725995|NCT01052831|Secondary|Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)|The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) was developed for use in clinical trials and added as a secondary outcome measure for assessment of change in severity of ICD symptoms, to be completed at baseline and end of study only. For the QUIP-RS, scores for each compulsive behavior range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. Given that ICD symptoms are frequently comorbid in patients with PD, total QUIP-RS ICD scores (range from 0 to 64) were used to compare overall severity of ICD symptoms. Please note that this measure is reporting a change from baseline.|The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).|A linear mixed-effects model was used to estimate changes in QUIP-RS ICD scores from baseline to termination (visit 5, 8 weeks after baseline). Positive estimated change values represent a decrease in severity (frequency) of symptoms.|||Change in points on a scale (QUIP-RS)||95% Confidence Interval|Number
2725996|NCT01052831|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used."|The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).||||percentage of responders|||Number
2725997|NCT01052779|Primary|Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5|The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).|Baseline (Day 1) and up to Week 5|ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).|||Participants|||Count of Participants
2725998|NCT01052779|Primary|Mean Change In Hemoglobin From Baseline (Day 1) To Week 5|"The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:~Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)~The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).|||g/dL||Standard Error|Least Squares Mean
2725999|NCT01052714|Primary|Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination|Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726000|NCT01052714|Primary|Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination|Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726001|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726002|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726003|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726004|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726005|NCT01052714|Primary|Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination|Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726006|NCT01052714|Primary|Change in Mean Total Exercise Time Per Week From Baseline to Termination|Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Minutes per week||Standard Error|Mean
2726007|NCT01052714|Primary|Change in Mean Empty Calories Consumed Per Week From Baseline to Termination|Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Calories per week||Standard Error|Mean
2726008|NCT01052714|Primary|Change in Mean Total Calories Consumed Per Week From Baseline to Termination|Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Calories per week||Standard Error|Mean
2726009|NCT01052714|Primary|Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination|Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.|Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
2726010|NCT01052714|Primary|Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Mg/dL per week||Standard Error|Mean
2726011|NCT01052714|Primary|Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Mg/dL per week||Standard Error|Mean
2726012|NCT01052714|Primary|Mean Triglycerides Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Mg/dL per week||Standard Error|Mean
2726013|NCT01052714|Primary|Mean Serum Insulin Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Pmol/L per week||Standard Error|Mean
2726014|NCT01052714|Primary|Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination|Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Units on a scale per week||Standard Error|Mean
2726015|NCT01052714|Primary|Mean Waist Circumference Change Per Week From Baseline to Termination|Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Inches per week||Standard Error|Mean
2726016|NCT01052714|Primary|Mean Weight Change Per Week From Baseline to Termination|Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Pounds per week||Standard Error|Mean
2726017|NCT01052701|Secondary|Plasma RBV Trough Concentrations|Plasma RBV trough concentrations.|Day 56||||micrograms per milliliter||Standard Deviation|Mean
2726018|NCT01052701|Primary|Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations|Ribavirin Triphosphate (RBV-TP) intracellular concentrations.|Day 56||||picomoles per 10^6 cells||Standard Deviation|Mean
2726019|NCT01052662|Primary|Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8|Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.|Weeks after buprenorphine discontinuation week 9|Participants that achieved complete abstinence by self-report that was confirmed with negative urine toxicology at week 8.|||participants|||Number
2726020|NCT01052662|Secondary|Treatment Retention|Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.|Weekly|Intent-treat-sample (ITT) that was inducted onto buprenorphine / naloxone and received one dose of study medication on week 2.|||weeks in treatment||95% Confidence Interval|Mean
2726021|NCT01052662|Primary|Change of Opioid Use From Week 1 to 13|The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.|Weekly from week 1 to 13|80 subjects intent-to-treat.|||Mean Proportion of Opioid Use in Week 13||Standard Error|Mean
2726022|NCT01052545|Secondary|Patient Level Analysis of Inappropriate Antibiotic Use|The investigators looked at the percentage of cases of ASB (asymptomatic bacteriuria) that were inappropriately over-treated with antibiotics, and the percentage of cases of CAUTI (catheter-associated UTI) that were not treated with antibiotics (under-treated).|three years|All patients on acute medical care wards or extended care wards during the three year study project who had a positive urine culture associated with the presence of a urinary catheter.|||percentage of cases|||Number
2726023|NCT01052545|Secondary|Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit||One year|inpatient-days on acute and extended care wards - aggregate numbers did not look at individual patients|||catheter-days of use/1000 pt bed days|bed-days||Number
2726024|NCT01052545|Secondary|Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines|"The investigators used a previous validated survey to measure this construct, which we termed risk perception. We asked 5 questions, all exploring whether various patient characteristics (age, type of organism) might increase providers' sense that untreated ASB might be a risk to their patient's health. These questions were scored on a 1-5 scale, from strongly disagree to strongly agree, with 5 being the best answer (compliant with guidelines about ASB treatment), and 1 being the worst answer (least likely to comply with ASB guidelines). Higher scores mean a better answer. Lower scores mean a worse answer. The minimum value was 1, and the maximum value was 5. To create a score for this domain, we added up the score for each of the 5 questions and divided by the number of questions answered (by 5 if all 5 questions were answered; by 4 if only 4 of the 5 questions had been answered; etc)."|one year|health care practitioners|||score on a scale||Standard Deviation|Mean
2726025|NCT01052545|Secondary|Clinicians' Awareness of and Familiarity With the ABU Guidelines.||one year|health care practitioners|||Participants|||Count of Participants
2726026|NCT01052545|Secondary|Number of Days Antibiotics Are Given to Treat ABU||one year|This data was not collected and is therefore not available.||||||
2726027|NCT01052545|Primary|Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)||Years 1, 2, & 3||||cases/1,000 bed-days||95% Confidence Interval|Number
2726028|NCT01052545|Primary|Urine Cultures Ordered|Number of urine cultures collected per 1000 catheter-days for each unit|three years|For this outcome measure, the number of participants is the number of patients that had urine cultures ordered. One patient could have multiple cultures ordered. Arm 1=5209 urine cultures ordered. Arm 2=5979 urine cultures ordered. This number was standardized by bed-days. Arm 1=170345 bed-days. Arm 2=119409 bed-days.|||Total ucx ordered/1,000 bed-days||95% Confidence Interval|Number
2726029|NCT01052545|Primary|Number of Cases of ABU That Are Treated Inappropriately With Antibiotics||Years 1, 2, & 3||||cases/1,000 bed-days||95% Confidence Interval|Number
2726153|NCT01051349|Secondary|Annual Change in Volume of New Gadolinium-Enhancing Lesions||From Baseline through 288 weeks|Gd enhancing lesion volume reflects acute inflammatory activity. The number of Gd lesions is a more valuable outcome measure. Hence the volume of Gd enhancing lesions was not assessed and reported.||||||
2726031|NCT01052480|Secondary|Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women|Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants|Measured through Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2726032|NCT01052480|Secondary|Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women|Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants|Measured through to Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2726033|NCT01052480|Secondary|Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs|Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with viral shedding >= LLOQ in nasal swabs at Day 0.|||days||Inter-Quartile Range|Median
2726034|NCT01052480|Secondary|Disposition Following Initial Hospitalization|"Disposition following initial hospitalization was categorized as follows: released home - home health care not required,  released home with home health care, transferred to long-term care facility, hospitalization ongoing at Day 28, deceased."|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||participants|||Number
2726035|NCT01052480|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726036|NCT01052480|Secondary|Days on Mechanical Ventilation|Time (in days) of mechanical ventilation use|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726037|NCT01052480|Secondary|Incidence of Acute Respiratory Distress Syndrome (ARDS) Present|Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.|Measured at Days 0, 1, 2, 4, 7, 14, 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This population is further restricted to those participants who did not have ARDS at Day 0.|||participants|||Number
2726038|NCT01052480|Secondary|Duration of Supplemental Oxygen|Duration of supplemental oxygen use in days|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726039|NCT01052480|Secondary|Days on Supplemental Oxygen|Time (in days) of supplemental oxygen use|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726040|NCT01052480|Secondary|Duration of Stay in ICU|Days that a participant spent in ICU. Multiple ICU admissions are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726041|NCT01052480|Secondary|Number of ICU Admissions|Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||participants|||Number
2726042|NCT01052480|Secondary|Duration of Hospitalization|Days that a participant spent at the hospital. Multiple hospitalizations are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726043|NCT01052480|Secondary|28-day Mortality|Number of deaths during study follow-up|Measured from Day 0 through Day 28|All randomized participants|||participants|||Number
2726044|NCT01052480|Secondary|In-hospital Mortality|Number of deaths in hospital during initial hospital admission|Measured from Day 0 through Day 28|All randomized participants|||participants|||Number
2726045|NCT01052480|Secondary|50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time|Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.|Measured at Days 1, 2, 4, 7, 14, 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with a PaO2/FiO2 ratio (ABG performed) at Day 0.|||participants|||Number
2726046|NCT01052480|Secondary|Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old|The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those >= 18 years with an available (non-zero) Day 0 SOFA evaluation.|||days||Inter-Quartile Range|Median
2726154|NCT01051349|Secondary|Annual Change in Number of T1 Hypointense Lesions||From Baseline through 288 weeks|T1 hypointense lesions changes reflect tissue destruction. Volume of T1 hypointense lesions is deemed a more valuable assessment. Hence number of T1 hypointense lesions were not assessed and reported.||||||
2726047|NCT01052480|Secondary|Duration of Time to Resolution of All Symptoms and Fever|The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726048|NCT01052480|Secondary|Duration of Time to Resolution of Fever|Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726049|NCT01052480|Secondary|Duration of Time to Resolution of Clinical Symptoms|The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726050|NCT01052480|Secondary|Time to Normalization of Respiratory Status (All Randomized Participants)|Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.|Measured from Day 0 through Day 28|All randomized participants|||days||Inter-Quartile Range|Median
2726051|NCT01052480|Primary|Time to Normalization of Respiratory Status (Primary Efficacy Population)|Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
2726052|NCT01052428|Primary|Peak Early Filling Rate: Rate of Change Over Time|Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||EDV/sec||Standard Deviation|Mean
2726053|NCT01052428|Primary|Systolic Longitudinal Strain|Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent/%Systolic interval||Standard Deviation|Mean
2726054|NCT01052428|Primary|Left Ventricular Ejection Fraction|Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent||Standard Deviation|Mean
2726055|NCT01052428|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area|Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
2726056|NCT01052428|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness|Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||unitless||Standard Deviation|Mean
2726057|NCT01052428|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||g/ml||Standard Deviation|Mean
2726058|NCT01052428|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area|Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
2726059|NCT01052272|Primary|Peak Early Filling Rate Normalized to EDV|The Peak Early Filling Rate Normalized to EDV is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||1/sec||Standard Deviation|Mean
2726151|NCT01051349|Secondary|Percent Change in Total Brain Volume|To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.|From Baseline through 288 weeks|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.|||percent change||Standard Deviation|Mean
2726060|NCT01052272|Primary|LV End Systolic Maximum Shortening (LVES Max Shortening)|By identifying three points in three different planes in the heart muscle, the maximum shortening is the average of the difference between the distance between these three points at the end of filling of the heart and the end of contraction divided by the length at the end of filling times 100. The maximum shortening is a three dimensional analysis. The higher values indicate a healthy heart. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent of length at end of filling||Standard Deviation|Mean
2726061|NCT01052272|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)|LVESV/BSA: The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
2726062|NCT01052272|Primary|Left Ventricular Ejection Fraction (LVEF)|LVEF is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent||Standard Deviation|Mean
2726063|NCT01052272|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)|LVED Mass/LVEDV: As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||g/ml||Standard Deviation|Mean
2726064|NCT01052272|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)|LVED Radius/Wall thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||unitless||Standard Deviation|Mean
2726065|NCT01052272|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)|LVEDV/BSA: As an indicator of heart size, the blood volume of the heart is related to the body size. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
2726066|NCT01052207|Secondary|Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker.||2 years|||||||
2726067|NCT01052207|Secondary|Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline.||2 years|||||||
2726068|NCT01052207|Primary|Pediatric Logistic Organ Dysfunction Score in Critically Ill Children|"Pediatric Logistic Organ Dysfunction also known as the PELOD Score is a marker of severity of illness for Critically ill children. The PELOD includes six organ dysfunctions and 12 variables.~To calculate the PELOD score, each organ dysfunction received points for the single variable associated with the most points. The minimum number that can be assigned to an organ is 0 and the maximum number of points for an organ is 20, and the maximum possible PELOD score is 71. Organ dysfunction is identified if the score for any organ system was more than 0."|1 years|PELOD scores are not calculated for healthy controls. The score was developed to assess critically ill patients only.|||scores on a scale||Standard Deviation|Mean
2726069|NCT01052116|Primary|Mean Change From Baseline to 24 Weeks for FEV1||24 weeks||||Liters||95% Confidence Interval|Mean
2726070|NCT01052077|Secondary|Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).|CGI-I Response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||participants|||Number
2726071|NCT01052077|Secondary|Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.|"A MADRS remission was defined as MADRS Total Score =< 10 and >= 50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place."|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||participants|||Number
2726072|NCT01052077|Secondary|Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.|"A MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place."|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||participants|||Number
2726073|NCT01052077|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participants total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2726074|NCT01052077|Secondary|Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score.|"The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the best rating and the highest score (2 or 4) was the worst rating. The possible total scores were from 0 to 52."|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2726075|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|The IDS-SR was a 30-item self-report measure, that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). For individual items, the scores range from 0 to 3. The IDS-SR are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84, higher values indicate greater disruption in the depressive symptoms.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2726076|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score.|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator had to answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2726077|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.|"The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place."|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2726078|NCT01052077|Secondary|Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. Scores of 5 and above are associated with significant functional impairment. The SDS total score ranges from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2726079|NCT01052077|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|"The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place."|Baseline (end of week 8) to Week 14|The efficacy sample was the Full Analysis Set (FAS) comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2726080|NCT01052038|Secondary|Hoarseness at 24 Hours|Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.|24 hours||||participants|||Number
2726081|NCT01052038|Secondary|Opioid Consumption at 24 Hours|The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.|24 hours||||mg of oral morphine equivalents||Inter-Quartile Range|Median
2726082|NCT01052038|Secondary|Number of Subjects With Sore Throat at 3 Hours Post Surgery.|Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.|3 hours.||||participants|||Number
2726083|NCT01052038|Secondary|Quality of Recovery at 24 Hours|The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery|24 hours||||units on a scale (30 to 200) higher scod||Inter-Quartile Range|Median
2726084|NCT01052038|Primary|Subjects Assessment of Sore Throat Pain at 24 Hours|The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.|24 hours||||units on a scale (1 to 5)||Inter-Quartile Range|Median
2726085|NCT01051986|Secondary|Early Angiographic Patency Rates|The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG|1.4days||||percentage of distal anastomoses|Participants||Number
2726086|NCT01051986|Secondary|Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)|freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years|4 years||||percentage of participants|||Number
2726087|NCT01051986|Secondary|Freedom From Cardiac Death|Freedom rate from cardiac death at 4 years|4 years||||percentage of participants|||Number
2726088|NCT01051986|Secondary|Overall Survival|Overall survival rate at 4 years|4 years||||percentage of participiciants|||Number
2726089|NCT01051986|Primary|1 Year Graft Patency Rates|1 year graft patency of second limb conduits measured by 1 year coronary angiography|one year||||percentage of distal anastomoses|Participants||Number
2726090|NCT01051921|Secondary|> 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks|"Percent of patients experiencing a drop in HCV-RNA Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 24 weeks of treatment."|Baseline and Study week 24|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.|||Percent of patients|||Number
2726091|NCT01051921|Primary|Early Virologic Response (EVR)|"Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment."|Baseline and Study week 12|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.|||Percent of Patients|||Number
2726092|NCT01051856|Secondary|Severity of the Pancreatic Fistula Leaks|Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.|90 days post operative||||Pancreatic fistula leaks|||Number
2726093|NCT01051856|Primary|Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation|Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.|90 days from the operation|Intention-to-treat analysis|||percentage of subjects|||Number
2726094|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T2 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|full analysis Set|||Cumulative new Gd-T2 lesions||Full Range|Mean
2726095|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T1 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|Full analysis set|||cumulative new Gd-T1 lesions||Full Range|Mean
2726096|NCT01051817|Primary|Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment|Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.|weeks 4,8,12,16,20,24,28|Full Analysis Set|||Combined Unique Active Lesions||Full Range|Mean
2726097|NCT01051791|Secondary|Objective Response Rate (ORR)|The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) / total evaluable patients.|Up to 60 months|Patients that completed at least 1 cycle of everolimus treatment. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.|||percentage of participants|||Number
2726098|NCT01051791|Secondary|Overall Survival (OS)||Up to 60 months||||months||Full Range|Median
2726099|NCT01051791|Secondary|Progression Free Survival (PFS)||Up to 60 months||||months||Full Range|Median
2726100|NCT01051791|Primary|Clinical Benefit Rate (CBR)|The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) + number of patients that experience Stable Disease (SD) / total evaluable patients.|Up to 60 months|Patients that completed at least 1 cycle of everolimus treatment.|||percentage of participants|||Number
2726101|NCT01051778|Secondary|Spontaneous Osteoporotic Fractures||Duration of pregnancy and puerperium|||||||
2726102|NCT01051778|Secondary|Preterm Delivery||24 weeks gestation<Pregnancy <37weeks gestation|||||||
2726103|NCT01051778|Secondary|IUFD||Pregnancy >24 weeks gestation|||||||
2726104|NCT01051778|Secondary|Preeclampsia||Pregnancy > 20 weeks gestation|||||||
2726105|NCT01051778|Secondary|Thrombocytopenia||Duration of pregnancy and puerperium|||||||
2726106|NCT01051778|Secondary|Minor and Major Bleeding||Duration of pregnancy and puerperium|||||||
2726107|NCT01051778|Primary|Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)|Live birth occurs when a fetus (> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.|pregnancy > 24weeks gestation||||Percentage of pregnancies|||Number
2726108|NCT01051739|Primary|Number of Subjects Progressing in Each Group Using Pointwise Linear Regression|Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.|4 years|Those that completed study|||participants|||Number
2726109|NCT01051596|Secondary|Percent of Patients With an Objective Response|Objective response rate defined as partial response or complete response according to RECIST criteria|2 months|All patients were evaluable for response, on an intention to treat basis|||Participants|||Count of Participants
2726110|NCT01051596|Secondary|Overall Survival|Overall survival defined as the time in days from study entry until death|1 year|All patients were evaluable for response, on an intention to treat basis|||Months||95% Confidence Interval|Median
2726111|NCT01051596|Secondary|Median Progression-free Survival Time|Progression-free survival defines as the time in days from study study entry until progression or death|1 year|All patients were evaluable for response, on an intention to treat basis|||Months||95% Confidence Interval|Median
2726112|NCT01051596|Primary|Percent of Patients With Disease Control|Disease control rate defined as stable disease, partial response, or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST).|2 months|Percent of patients with disease control, according to the Response Evaluation Criteria in Solid Tumors (RECIST).|||Participants|||Count of Participants
2726113|NCT01051570|Secondary|Overall Survival||After treatment, participants will be contacted every 3 months|||||||
2726114|NCT01051570|Secondary|Pharmacokinetics||Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2|||||||
2726115|NCT01051570|Secondary|Association of TTP and PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)||Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose|||||||
2726116|NCT01051570|Secondary|PSA Response Rate||Day 1 of each cycle (every 21 days)|||||||
2726117|NCT01051570|Secondary|Toxicity as Measured by NCI CTCAE v3.0 Criteria||Day 1 of each cycle (every 21 days)|||||||
2726118|NCT01051570|Primary|Time to Progression (TTP)|Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.||||months||90% Confidence Interval|Median
2726119|NCT01051557|Primary|Determine the Efficacy of Temsirolimus in Combination With Perifosine in Patients With Recurrent/Progressive Glioblastomas (GBMs) Not Taking EIAEDs as Measured by 6 Month Progression-free Survival (6mPFS) and Radiographic Response Rates. (Phase II)||5 years|Data were not collect as as study did not progress to Phase II.||||||
2726120|NCT01051557|Primary|Maximum Tolerated Dose of Temsirolimus|MTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)|28 days||||mg/week|||Number
2726121|NCT01051518|Secondary|Composite Technical Device Success|"Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the Device Functionality Assessment was achieved and who were adjudicated as having no device failure or malfunction.~The four measures of the ''Device Functionality Assessment'' were:~Load the valve delivery system using the loading system~Access the aortic valve with the delivery catheter~Deploy the valve accurately across the native aortic valve~Remove the intact delivery system"|Was assessed during the procedure and completed once the procedure was conlcluded|For two patients in the moderate risk group the composite technical device success could not be calculated because not all measurements required were available.|||Percentage of subjects||95% Confidence Interval|Number
2726152|NCT01051349|Secondary|Annual Change in Volume of T1 Hypointense Lesions|Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.|From Baseline through 288 weeks|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.|||mm^3||Standard Deviation|Mean
2726122|NCT01051518|Primary|Composite Major Adverse Event (MAE) Free Rate|Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.|30 (+7) days post procedure||||Percentage of subjects||95% Confidence Interval|Number
2726123|NCT01051466|Secondary|Incidence of Suicidal Behavior and Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline."|Baseline through Week 12|Participants with MDD who had a baseline and at least 1 post-baseline C-SSRS assessment. Healthy participants did not have a C-SSRS assessment post baseline.|||participants|||Number
2726124|NCT01051466|Secondary|Hamilton Anxiety Rating Scale (HAMA)|The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMA observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
2726125|NCT01051466|Secondary|Patient's Global Impressions of Improvement (PGI-I) Scale|The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse).|Baseline, up to Week 12|Enrolled MDD participants who had at least 1 post-baseline PGI-I observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome. PGI-I observations were not completed for healthy participants.|||units on a scale||Standard Deviation|Mean
2726126|NCT01051466|Secondary|Clinical Global Impressions of Severity Scale (CGI-S)|The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline CGI-S observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
2726127|NCT01051466|Secondary|Sheehan Disability Scale (SDS)|The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life.|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline SDS observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
2726128|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Remission|HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||percentage of participants|||Number
2726129|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Response|HAMD17 response is defined as a >50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a >50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||percentage of participants|||Number
2726130|NCT01051466|Secondary|17-Item Hamilton Depression Rating Scale (HAMD17)|The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
2726131|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Proinflammatory Cytokines [Tumor Necrosis Factor Alpha (TNFα), Interleukin 1 (IL-1), and Interleukin 6 (IL-6)]|Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline cytokine observation (TNFα, IL-1, or IL-6), excluding 3 healthy participants who did not meet entry criteria.|||picograms per milliliter (pg/mL)||Standard Error|Least Squares Mean
2726132|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF) Receptors|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline trkB observation, excluding 3 healthy participants who did not meet entry criteria. No participant was analyzed for the change from baseline in p75NTR receptors.|||picograms per milligram (pg/mg)||Standard Error|Least Squares Mean
2726133|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF)|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline BDNF or proBDNF observation, excluding 3 healthy participants who did not meet entry criteria.|||nanograms per milliliter (ng/mL)||Standard Error|Least Squares Mean
2726134|NCT01051466|Secondary|Gs Alpha (Gsα)-Activated Adenylyl Cyclase|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Adenylyl cyclase is activated by Gsα, and when Gsα is translocated from lipid rafts it more effectively activates adenylyl cyclase. Gsα-activated adenylyl cyclase was not analyzed due to technical laboratory issues.|Baseline and Weeks 1, 8, and 12|No participants were analyzed.||||||
2726135|NCT01051466|Secondary|Translocation of Gs Alpha (Gsα) From Lipid Rafts in the Cell Membranes of Red Blood Cells (RBCs), White Blood Cells (WBCs) and Platelets Compared With Baseline|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Weeks 1, 8, and 12|Enrolled participants who had a baseline and at least 1 post-baseline Gsα localization observation, excluding 3 healthy participants who did not meet entry criteria. No participants were analyzed for the translocation of Gsα from lipid rafts in the cell membranes of WBCs.|||Ratio||Standard Error|Least Squares Mean
2726136|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Volume of Subgenual Anterior Cingulate, Amygdalae, and Hippocampus|The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline observation for the volume of specific brain regions, excluding 3 healthy participants who did not meet entry criteria.|||cubic millimeters (mm^3)||Standard Error|Least Squares Mean
2726137|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Activation [Blood Oxygenation-Level-Dependent (BOLD) Response to Implicit Processing of Sad Faces] for Each of the 3 Brain Regions|Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation, excluding 3 healthy participants who did not meet entry criteria.|||percentage of signal change||Standard Error|Least Squares Mean
2726149|NCT01051349|Secondary|Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365. Adjusted ARR was reported.|Week 288|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.|||relapses per person-year||95% Confidence Interval|Number
2726138|NCT01051466|Primary|Change From Baseline to 12-Week Endpoint in the Functional Magnetic Resonance Imaging (fMRI) Mean Blood Oxygenation-Level-Dependent (BOLD) Response in the Amygdalae|Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation.|||percentage of signal change||Standard Error|Least Squares Mean
2726139|NCT01051440|Secondary|Change in Clinical Global Impressions Improvement (CGI-I) Score.|The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status.|week 1 and week 9|All participants who were randomized to lisdexamfetamine or placebo were included.|||units on a scale|||Number
2726140|NCT01051440|Secondary|Change in Clinical Global Impressions Severity (CGI-S) Score.|"The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of normal, not at all ill to 7 with an anchor of among the most extremely ill patients. Thus, higher scores indicate greater severity of symptoms."|baseline and week 8|All participants who were randomized to lisdexamfetamine or placebo were included.|||units on a scale|||Number
2726141|NCT01051440|Primary|Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.|The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.|baseline and 8 weeks|All participants randomized to lisdexamfetamine or placebo were included.|||units on a scale|||Number
2726142|NCT01051349|Secondary|Summary of Injection Site Assessment Performed by Clinician|"Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported.~Here, Injection=Inj, post-dose=PD"|First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose|The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points.|||Participants|||Count of Participants
2726143|NCT01051349|Secondary|Participant-Reported Pain Visual Analog Scale (VAS) Score|"The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end (0 [no pain] on the left and 100 [very painful] on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain."|First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose|The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points.|||score on a scale||Standard Deviation|Mean
2726144|NCT01051349|Secondary|Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4||Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose|Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.|||mg/mL||Standard Deviation|Mean
2726145|NCT01051349|Secondary|Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4||Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose|Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.|||hour||Full Range|Median
2726146|NCT01051349|Secondary|Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab||Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose|Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.|||mg/mL||Standard Deviation|Mean
2726147|NCT01051349|Secondary|Number of Participants With Sustained Disability Progression for 24 Weeks|Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.|Week 48 up to Week 288|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.|||Participants|||Count of Participants
2726148|NCT01051349|Secondary|Number of Participants With Sustained Disability Progression for 12 Weeks|Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.|Week 48 up to Week 288|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.|||Participants|||Count of Participants
2726155|NCT01051349|Secondary|Number of Participants With Total Number of New Gadolinium-enhancing Lesions|New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.|From Baseline through 288 weeks|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.|||Participants|||Count of Participants
2726156|NCT01051349|Secondary|Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline|New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.|From Baseline through 288 weeks|ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.|||mm^3||Standard Deviation|Mean
2726157|NCT01051349|Secondary|Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline|New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.|From Baseline through 288 weeks|Intent-to-treat (ITT) population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.|||Participants|||Count of Participants
2726158|NCT01051349|Primary|Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab||Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose|Pharmacokinetic analysis population included all participants in the Autoinjector Substudy with a sufficient number of samples available for analysis by randomized treatment group.|||hr*mg/mL||Standard Deviation|Mean
2726159|NCT01051349|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)|Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.|||Participants|||Count of Participants
2726160|NCT01051323|Secondary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.|||mcg||Standard Deviation|Mean
2726161|NCT01051323|Primary|Number of Participants Satisfied With Treatment at Final Visit|"Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were very satisfied, satisfied, undecided, or not satisfied. Data for this outcome measure was reported for overall participants."|Month 12 or early discontinuation|FAS|||participants|||Number
2726162|NCT01051323|Primary|Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy|Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.|||participants|||Number
2726163|NCT01051323|Primary|Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion|At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.|||participants|||Number
2726164|NCT01051323|Primary|Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion|"At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants."|Month 12 or early discontinuation|FAS|||participants|||Number
2726165|NCT01051323|Primary|Number of Physicians Satisfied With Treatment at Final Visit|"Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were very satisfied, satisfied, undecided, or not satisfied. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants."|Month 12 or early discontinuation|FAS|||physicians|||Number
2726166|NCT01051323|Primary|C-reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.|||mg/dL||Standard Deviation|Mean
2726167|NCT01051323|Primary|Transferrin Saturation Values|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.|||percent transferrin saturation||Standard Deviation|Mean
2726168|NCT01051323|Primary|Transferrin Values|Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.|||mg/dL||Standard Deviation|Mean
2726169|NCT01051323|Primary|Serum Iron Values|Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.|||mcg/dL||Standard Deviation|Mean
2726170|NCT01051323|Primary|Serum Ferritin Values|Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.|||ng/mL||Standard Deviation|Mean
2726171|NCT01051323|Primary|Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size|For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.|Month 0 to Month 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.|||g/dL||Standard Deviation|Mean
2726172|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.|Month 6 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.|||percentage of participants|||Number
2726173|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.|Month 0 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.|||percentage of participants|||Number
2726174|NCT01051323|Primary|Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range|Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.|Month 0 to Month 12|FAS|||percentage of participants|||Number
2726175|NCT01051310|Primary|Technical Success.|The number of subjects in whom technical success was achieved where technical success was defined based on the device functionality as judged by the investigator adressing the ability of the system (1) to access the failing bioprosthetic valve via a peripheral vessel with the delivery catheter and (2) to deploy the valve accurately across the failing bioprosthetic valve and (3) to remove intact delivery system.|30 days post procedure||||Participants|||Count of Participants
2726176|NCT01051310|Primary|Percentage of MAE Free Subjects|"Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes:~MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement.~MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure."|30 days post-procedure||||Participants|||Count of Participants
2726177|NCT01051063|Secondary|Number of Patients With Abnormal Hematological and Biochemical Parameters|Haematological and biochemical parameters assessed were Alanine aminotransferase, Aspartate aminotransferase, Alkaline Phosphatase, Bilirubin, Creatinine, Gamma-glutamyl transpeptidase, Hemoglobin, Hypercalcemia, Hyperkalemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypokalemia, Hyponatremia, Leukocytes, Lymphopenia, Neutrophils, Platelets and Proteinuria. Parameters were assessed as per the Common Terminology Criteria for adverse events (CTCAE), where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe but not life-threatening and Grade 4 = life-threatening.|During the entire study (Month 0 to Month 49)|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.|||Participants|||Count of Participants
2726178|NCT01051063|Secondary|Number of Subjects With Any or Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as causally related to the study treatment. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the CRF, but not as an SAE.|During the entire study (from Month 0 to Month 49)|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.|||Participants|||Count of Participants
2726272|NCT01050764|Secondary|Acute Graft-versus-Host-Disease (aGvHD)|The primary outcome was incidence of grade 3 or 4 acute graft-vs-host-disease (aGvHD), reported as the number of participants developing grade 3 or 4 aGvHD.|1 year|Population of participants that received HSCT and T-reg plus T-con|||Participants|||Count of Participants
2726179|NCT01051063|Secondary|Number of Subjects With Study Treatment Failure|Study treatment failure was defined as withdrawal from investigational product because of disease progression or death. Among the characteristics evaluated were: Progression, Death in absence of Relapse, Relapse or progression or Death (Progression Free Survival event), Death [An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE], Autopsy performed and Cause of death.|During the entire study (from Month 0 to Month 49)|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product.|||Participants|||Count of Participants
2726180|NCT01051063|Secondary|Number of Subjects With Any and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Related = AE assessed by the investigator as causally related to the study treatment.|Starting with the first administration of study treatment and ending 30 days after the last study treatment administration|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.|||Participants|||Count of Participants
2726181|NCT01051063|Secondary|Anti-WT1 Antibody Response|"The anti-WT1 antibody response was defined as:~For initially seronegative patients, post-vaccination antibody concentration ≥ 9 EU/mL; For initially seropositive patients, post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration."|At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.|||Participants|||Count of Participants
2726182|NCT01051063|Secondary|Anti-WT1 Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations, measured in ELISA units per milliliter (EU/mL).|At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.|||EU/mL||95% Confidence Interval|Geometric Mean
2726183|NCT01051063|Secondary|Anti-WT1 Seropositivity Rate|Seropositivity rate was defined as the number of patients with anti-WT1 antibody concentrations greater than or equal to (≥) 9 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).|At baseline (PRE), weeks (W) 5, 9, 13, 15, 21, 32, 40, 54, at months 15, 18, 21, 24, 30, 36, 42 and 49 (concluding visit), as well as follow-up visits 1 to 4|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product. For the purpose of the analysis, patients were pooled into a single group and results were tabulated for the Total Treated Group.|||Participants|||Count of Participants
2726184|NCT01051063|Primary|Number of Patients With Best Overall Response, Defined by Either Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)|"CR = having < 5% blasts in aspirate sample with marrow spicules and with a count of ≥ 200 nucleated cells, no blasts with Auer rods or persistence of extramedullary disease; different phenotype (by flow cytometry) to the pre-treatment specimen; absolute neutrophil count > 1000/mm3; platelet count ≥ 100 000/mm3 and being independent of red blood cell (RBC) transfusions.~PR = a decrease of ≤ 50% in the % of blasts in bone marrow aspirate compared to Visit 4; being independent of RBC transfusions and the absolute neutrophil ≥ 1000/mm3 and platelet counts and ≥ 100 000/mm3.~SD = no sufficient criteria for CR, a PR or Progressive disease (PD = Reappearance of leukemic blasts in the peripheral blood; Reappearance/development of cytologically proven extramedullary disease, Appearance of new dysplastic changes, or in a bone marrow aspirate sample (with marrow spicules and with a count of ≥200 nucleated cells) of ≥5% blasts; or, in case of early progression, a higher blast % than at Visit 4)."|During the entire study (from Month 0 to Month 49)|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product.|||Participants|||Count of Participants
2726185|NCT01051063|Primary|Number of Patients With Severe Toxicities|"Severe toxicities (as classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related:~Grade 4 toxicity (exception: study product-related or possibly study product-related Grade 4 fatigue - including lethargy, asthenia, and malaise - had to have a duration of at least 48 hours to be taken into account).~Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration).~Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition.~Decrease in renal function, with a calculated creatinine clearance < 40 mL/min.~Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina)."|During the entire study (from Month 0 to Month 49)|The analysis was performed on the Total Treated population, which included all enrolled patients who had been administered at least one dose of the study product.|||Participants|||Count of Participants
2726186|NCT01050998|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|ADA detection measured by using electrochemiluminescence assays.|Day 1 up to Day 169|The immunogenicity population included all participants who received at least 1 dose of CAM-3001 and for whom at least one serum sample for immunogenicity testing was available.|||participants|||Number
2726273|NCT01050764|Primary|Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells|The maximum-tolerated dose (MTD) was to be determined based on the safety and feasibility observed for a pre-determined set of cellular dose level combinations of regulatory T-cells (T-reg) and conventional T-cells (T-con).|30 days after HSCT infusion|Includes all participants that received HSCT|||cells/kg|||Number
2726187|NCT01050998|Secondary|Accumulation Ratio for Mavrilimumab After Last Dose by Region|Accumulation ratio was calculated as ratio of AUCtau after last dose and AUCtau after first dose. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||ratio||Standard Deviation|Geometric Mean
2726188|NCT01050998|Secondary|Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||days||Standard Deviation|Mean
2726189|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||ng*day/mL||Standard Deviation|Geometric Mean
2726190|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||days||Full Range|Median
2726191|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||ng/mL||Standard Deviation|Geometric Mean
2726192|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Geometric Mean
2726193|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||days||Full Range|Median
2726194|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2726195|NCT01050998|Secondary|Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose|"Participants received MTX at stable and tolerated dose during baseline were categorized as low dose (<12.5 mg per week [mg/wk]), medium dose (>=12.5 - <20 mg/wk), and high dose (>=20 mg/wk). Participants received oral CST at stable dose during baseline were categorized as low dose (<5 mg/day), and high dose (>=5 mg/day). Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: 'Increased', 'no change' and 'decreased'. Participants were counted once with dose increases counted first, followed by no change and then dose decreases."|Baseline, Day 1 to 85, Day 86 to 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified parameter for each arm, respectively."|||participants|||Number
2726196|NCT01050998|Secondary|Number of Participants Who Had Additional Medications|Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis [RA]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system.|Baseline up to Day 169|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||participants|||Number
2726274|NCT01050673|Secondary|Number of Patient's With Serious Adverse Events and Relationship to Device||28 days||||Number of patients|||Number
2726197|NCT01050998|Secondary|Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units per milliliter||Standard Deviation|Mean
2726198|NCT01050998|Secondary|Serum Concentration of Rheumatoid Factor (RF)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units per milliliter||Standard Deviation|Mean
2726199|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||mm/hr||Standard Deviation|Mean
2726200|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hr||Standard Deviation|Mean
2726201|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP) by Region|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||mg/L||Standard Deviation|Mean
2726202|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/L||Standard Deviation|Mean
2726203|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score by Region|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2726204|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2726205|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2726206|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2726207|NCT01050998|Secondary|Patient Pain Assessment Score by Region|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||mm||Standard Deviation|Mean
2726208|NCT01050998|Secondary|Patient Pain Assessment Score|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm||Standard Deviation|Mean
2726209|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score by Region|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported."|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||mm||Standard Deviation|Mean
2726210|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
2726211|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score by Region|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||cm||Standard Deviation|Mean
2726212|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score|Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||cm||Standard Deviation|Mean
2726213|NCT01050998|Secondary|Swollen and Tender Joint Count by Region|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Data for the European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||joints||Standard Deviation|Mean
2726214|NCT01050998|Secondary|Swollen and Tender Joint Count|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||joints||Standard Deviation|Mean
2726215|NCT01050998|Secondary|Continuous ACR (ACRn) Score by Region|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Error|Mean
2726216|NCT01050998|Secondary|Continuous ACR (ACRn) Score|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Error|Mean
2726217|NCT01050998|Secondary|Number of Participants Who Achieved ACR Categorical Responses|"ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as No response, ACR20 but not ACR50, ACR50 but not ACR70, and ACR70."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||participants|||Number
2726218|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region|ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percentage of participants|||Number
2726219|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85|ACR20, ACR50, and ACR70, were defined as greater than or equal to (>=) 20 percent (%),>=50%, or >=70% improvement, respectively, in: swollen joint count and tender joint count and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
2726220|NCT01050998|Secondary|Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population.|Baseline up to Day 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified parameter for each arm, respectively."|||Percentage of days|||Number
2726221|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.|Baseline up to Day 169 (follow-up)|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||days||95% Confidence Interval|Median
2726222|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score.|Baseline up to Day 169 (follow-up)|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||days||95% Confidence Interval|Median
2726223|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percentage of participants|||Number
2726224|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
2726225|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Error|Mean
2726226|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2726227|NCT01050998|Primary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
2726228|NCT01050998|Primary|Change From Baseline in Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||percent saturation||Standard Deviation|Mean
2726229|NCT01050998|Primary|Oxygen Saturation Level at Day 85 by Region|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percent saturation||Standard Deviation|Mean
2726230|NCT01050998|Primary|Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||percent saturation||Standard Deviation|Mean
2726231|NCT01050998|Primary|Categorized Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||participants|||Number
2726232|NCT01050998|Primary|Change From Baseline in Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2726233|NCT01050998|Primary|Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2726234|NCT01050998|Primary|Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||percent diffusion capacity||Standard Deviation|Mean
2726235|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percent diffusion capacity||Standard Deviation|Mean
2726236|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||percent diffusion capacity||Standard Deviation|Mean
2726237|NCT01050998|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||liters||Standard Deviation|Mean
2726238|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||liters||Standard Deviation|Mean
2726239|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 85|The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liters||Standard Deviation|Mean
2726240|NCT01050998|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Results|12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator's discretion were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
2726241|NCT01050998|Primary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
2726242|NCT01050998|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
2726243|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
2726244|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
2726245|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
2726246|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
2726247|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
2726248|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
2726249|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
2726250|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Day 85|The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
2726251|NCT01050946|Secondary|Disease-free Survival:Death or Relapse Will be Considered Events for This Endpoint.||3 years||||participants|||Number
2726252|NCT01050946|Secondary|Transplant Related Mortality (TRM): TRM is Death Occurring in Patients in Continuous Complete Remission.||1 year|only pt who was enrolled died of TRM|||participants|||Number
2726253|NCT01050946|Secondary|Time to Acute GVHD: We Will Assess the Incidence and Severity of Grades II-IV and Grades III-IV Acute GVHD From Day of Transplant.||100 days|only one participant - no analysis done||||||
2726254|NCT01050946|Secondary|Time to Platelet Engraftment: To Assess the Incidence of Platelet Engraftment From Day of Transplant,||100 days|No further analysis reported as only one patient enrolled||||||
2726255|NCT01050946|Secondary|Time to Neutrophil Engraftment: To Assess the Incidence of Neutrophil Engraftment From Day of Transplant|time to neutrophil recovery after transplant|100 days|Patient engrafted neutrophils and platelets but no statistical analysis possible||||||
2726256|NCT01050946|Secondary|Time to Relapse: To Assess the Incidence of Acute Leukemia or Lymphoma Relapse From Day of Transplant|NOT analyzed since there was only patient and no relapse was observed till patient passed away|2 years|Patient did not live to 2 years, no relapse observed||||||
2726257|NCT01050946|Primary|The Primary Objective is to Estimate the Overall Survival, Separately in the Two Risk Strata.||3 years|Only one patient enrolled on study. Patient died prior to time frame of 3 years. It is not possible to assess this outcome measure.||||||
2726275|NCT01050673|Secondary|Number of Patient's With Wound-related Readmissions||28 days and 6 week follow up||||Number of patients|||Number
2726276|NCT01050673|Secondary|Length of Hospital Stay (1st Excision to Discharge (Days))||28 days||||Days||Standard Deviation|Median
2726277|NCT01050673|Secondary|Percentage of Patients Achieving Stable Closure Within Study Period||28 days||||percentage of patients|||Number
2726258|NCT01050816|Secondary|Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery|The Modified Hannover Score System contains information about patient's status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)|||scores||Standard Deviation|Mean
2726259|NCT01050816|Secondary|Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery|"A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.~The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point."|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)|||mm||Standard Deviation|Mean
2726260|NCT01050816|Primary|Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery|"AOFAS scores(best score-100,worst score- 0 )~pain-none:40/Strong and Always present:O~Function~activities-without support activities:10/need restrain, clutch , walker or wheelchair:0~Maximum gait distance- more than 6:5/ less than 1:0~gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0~Gait abnormality-none:8/marked:0~saggital mobidity- normal or minimal restrain:6/strong restraint:0~hindfoot mobidity -normal minimal restrain:6/strong restrain:0~ankle and hindfoot stability - stable:8/unstable:0~alignment- good:10/bad:0"|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for Full Analysis Set(FAS) analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)|||scores||Standard Deviation|Mean
2726261|NCT01050790|Secondary|CTA Expression Before and After Azacitidine Therapy|Six patients tested have demonstrated CTA up-regulation in either unfractionated bone marrow (n = 4) or CD138+ cells (n = 2). CTA (CTAG1B)-specific T cell response has been observed in all three patients tested and persists following SCT.|3 months||||participants|||Number
2726262|NCT01050790|Secondary|Pre- and Post-ALI Immune Response to Cancer Testis Antigens (CTA)|Not able to obtain outcome data.|6 months|Not able to obtain outcome data. The lab doing this correlative analysis lost the personnel support to process the samples.||||||
2726263|NCT01050790|Secondary|Progression-free and Overall Survival|"Survival and event-free survival curves (any event of fatality, relapse, acute or chronic GVHD) with Kaplan-Meier curves. The incidence curve for relapse - accounting for the competing risk of fatality - is plotted with step-wise curves. The R statistical software (version 2.15) was used for all time-to-event analyses, with the survival package used for survival curves, and the cmprsk package used for all competing risk curves.~Results: The one-year survival rate is 93.3% (SE = 0.4%), and the two-year survival rate is 86.1% (SE = 0.9%)."|1 year to 2 years|The outcome measure data was collected up to one to two years post transplant.|||percentage of participants||95% Confidence Interval|Number
2726264|NCT01050790|Secondary|Time to Progression Post Transplant|Time to progression post transplant: For patients not in Complete Response (CR), progressive disease requires one or more: >25% increase in the level of the serum monoclonal paraprotein(absolute increase of at least 0.5 g/dL); > 25% increase in 24-hour urinary light chain excretion(absolute increase of at least 200m/24 hours). Increase plasma cells in a bone marrow aspirate( absolute increase of at least 10%). Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum Ca > 11.5 mg/dL or > 2.65 mmol/L) not attributable to any other cause. All relapse categories require two consecutive assessments made any time before classification as relapse or progressive disease.|28 months|Progression is collected anytime after transplant.|||months||Full Range|Median
2726265|NCT01050790|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Time frame includes after stem cell transplant engraftment. Toxicity post ALI infusion: 1 patient grade 1 hypertension 90 min post infusion. Toxicity post Rev maintenance: 1 patient not tolerated, 1 patient dose decreased due to counts.|6 months||||participants|||Number
2726266|NCT01050790|Secondary|Complete Response Rate at 6 Months|16 of 17 patients proceeded to transplant. 6 month CR rate post transplant was 8/16 (50%).|6 months|1 patient did not proceed to transplant.|||percentage of participants|||Number
2726267|NCT01050790|Primary|Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment|Time frame is post 2nd and 3rd cycles of rev/aza and after stem cell transplant engraftment.|6 months|17 of 17 patients were able to mobilize lymphocytes. 16 of 17 patients had lymphocytes infused post transplant. 1 patient was not able to mobilize stem cells and so did not go to transplant.|||participants|||Number
2726268|NCT01050764|Secondary|Serious Infections|Serious infections are reported as the number of participants experienced serious infections.|1 year|Population of participants that received HSCT and T-reg plus T-con|||Participants|||Count of Participants
2726269|NCT01050764|Secondary|To Measure the Incidence and Severity of Acute and Chronic GvHD|Population of participants that received HSCT and T-reg plus T-con, and developed actue, chronic, or any graft vs host disease (GvHD)|1 year||||Participants|||Count of Participants
2726270|NCT01050764|Secondary|Median Overall Survival (OS)|Reported as the median overall survival (OS) in months from infusion of the hematopoietic stem cells (HSCT)|25 months|Population of participants that received HSCT and T-reg plus T-con|||months||Standard Deviation|Median
2726271|NCT01050764|Secondary|Overall Survival (OS), 1 Year|Assessed as subjects remaining alive 12 months after CD34+ cell infusion (ie, excludes death due to any cause)|1 year|Population of participants that received HSCT and T-reg plus T-con|||Participants|||Number
2726292|NCT01050660|Primary|The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.||28 days of age or when full enteral nutrition is acheived, whichever is longer|"Incidence of PNALD at Yale and UCLA NICU prior to the start of the study was around 40%.~Our goal was to decrease incidence by 50%/ Alpha of 5%/ Power of 80% We calculated a sample size of 65 infants in each group"|||participants who developed Cholestasis|||Number
2726293|NCT01050647|Secondary|Length of Latency Assessed as Number of Days||From rupture of membranes until delivery, assessed up to 34 weeks of gestation||||days||95% Confidence Interval|Median
2726294|NCT01050647|Secondary|Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days||From birth to discharge form delivery hospital, assessed up to 2 months||||days||95% Confidence Interval|Mean
2726295|NCT01050647|Secondary|Number of Participants With Neonatal Necrotizing Enterocolitis||From delivery to neonatal discharge, assessed up to 2 months||||Participants|||Count of Participants
2726296|NCT01050647|Secondary|Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage||From delivery until neonatal hospital discharge, assessed up to 2 months||||Participants|||Count of Participants
2726297|NCT01050647|Secondary|Number of Participants With Neonatal Respiratory Distress Syndrome||From delivery until neonatal hospital discharge, assessed up to 2 months||||Participants|||Count of Participants
2726298|NCT01050647|Primary|Number of Participants With Achievement of 34 Weeks Gestation|Delayed delivery until 34 weeks gestation.|From enrollment until delivery, an average of 34 weeks||||Participants|||Count of Participants
2726299|NCT01050634|Primary|Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26|The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.|||Scores on a scale (mm)||Standard Deviation|Mean
2726300|NCT01050634|Primary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores|Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities & 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less & 5.Limited in kind of work due to physical health, 6.Accomplished less & 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm & 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted & 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.|||Scores on a scale||Standard Deviation|Mean
2726301|NCT01050634|Primary|Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26|Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused - all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100|Baseline, Month 12|FAS=Number of participants analyzed. Missing values were imputed by LOCF. Number of subjects analyzed for single LASA item (n)=Number of subjects with Baseline and Final Visit (LOCF) scores for the single item.|||mm||Standard Deviation|Mean
2726302|NCT01050634|Primary|Change From Baseline in Thickness of Endometrium|"Ultrasound measurement. New derived variable for normalization of endometrium thickness:~1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm"|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.|||mm||Standard Deviation|Mean
2726303|NCT01050634|Primary|Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores|10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100|Baseline, Month 12|Full Analysis Set (FAS)=Subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy measurement=Number of participants analyzed. Missing values were imputed by last observation carried forward (LOCF). Subjects analyzed for single item (n)=Subjects with Baseline and Final Visit (LOCF) scores for the item|||mm||Standard Deviation|Mean
2726304|NCT01050582|Secondary|Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events|Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma.|Retrospectively during the time of exposure for up to 2 years prior to the study visit||||participants|||Number
2726305|NCT01050582|Secondary|Age (Years) at Current Tanner Stage|Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment.|One single study visit, approximately one week after informed consent has been obtained|Participants with a physician assessed Tanner stage value.|||years||Standard Deviation|Mean
2726351|NCT01050062|Secondary|Systolic Blood Pressure (SBP)|SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||mmHg||Standard Deviation|Mean
2726306|NCT01050582|Primary|Height (cm) Z-score at Study Visit|Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.|One single study visit, approximately one week after informed consent has been obtained|All participants with a height assessment available at the study visit.|||z-score||Standard Deviation|Mean
2726307|NCT01050569|Secondary|Time to Lapse or Relapse to Tobacco Use||26 weeks||||weeks||95% Confidence Interval|Median
2726308|NCT01050569|Secondary|Exposure to Tobacco Toxicants||6 weeks||||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
2726309|NCT01050569|Primary|End of Follow-up Abstinence Rates|CO- and cotinine-verified point prevalence abstinence|36 weeks||||participants|||Number
2726310|NCT01050569|Primary|End of Treatment Abstinence Rate|Cotinine and carbon monoxide (CO) verified point prevalence abstinence|12 week||||participants|||Number
2726311|NCT01050543|Primary|Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery.|From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)|Full Analysis Set, defined as all participants who received randomized treatment and had at least one efficacy measurement.|||minutes||95% Confidence Interval|Geometric Mean
2726312|NCT01050530|Secondary|Ascites Volume|Change in ascites volume from baseline as measured by CT at end of treatment|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF|||mL||Standard Deviation|Mean
2726313|NCT01050530|Primary|Body ｗeight|Change in body weight from baseline after 7-day repeated oral administration of OPC|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF|||Kg||Standard Deviation|Mean
2726314|NCT01050257|Secondary|Percentage of Participants With Influenza Symptoms|Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.|Days 1, 11, 15, 30|Intent-to-Treat population included all treated participants.|||Percentage of participants|||Number
2726315|NCT01050257|Secondary|Number of Participants With Viral Resistance|Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing. Viral resistance was determined by phenotypic and genotypic testing.|30 days|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Participants|||Number
2726316|NCT01050257|Secondary|Time to Resolution of Fever for Participants Who Had a Fever at Baseline|Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius). Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.|Baseline, Up to 30 Days|Participants from the Intent-to-Treat Infected population, all treated participants with confirmed influenza infection by culture or RT-PCR, who had a fever at Baseline.|||Hours||95% Confidence Interval|Median
2726317|NCT01050257|Secondary|Percentage of Participants Who Had a Fever During the Study|Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).|Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
2726318|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4|Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis. Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL). A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-Treat Infected population with data available for analysis. Only participants with positive influenza results are included.|||log 10 copies/mL||Standard Deviation|Mean
2726319|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Culture at Day 4|Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis. Viral influenza titer (amount of virus present) was determined by culture. A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture. A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-treat Influenza Infected population with data available for analysis. Only participants with positive influenza results are included.|||log10 TCID50||Standard Deviation|Mean
2726320|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
2726321|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.|Days 1, 4, 6, 11, 15, 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
2726322|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture or RT-PCR|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
2726323|NCT01050257|Secondary|Pharmacokinetics||Days 1, 3||2013-12-31|12/2013||||
2726324|NCT01050257|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death|"Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug."|Up to 30 days|Safety population included all participants who received treatment and had at least one post-treatment safety assessment. One patient in the 100 mg group actually received 200 mg and is included in the 200 mg group for safety.|||Partipants|||Number
2726325|NCT01050218|Primary|Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).|The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.|Baseline and 9 months|The efficacy population was the intent-to-treat (ITT). This included all randomized subjects who had a baseline primary efficacy evaluation, had taken at least 1 dose of test article, and had at least 1 primary efficacy evaluation (ie, at least 1 NRS daily pain score) after the first dose of test article. No participants met that criterion.|||units on scale|||Number
2726326|NCT01050205|Secondary|Changes in Diastolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff's sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mmHg||Standard Deviation|Mean
2726327|NCT01050205|Secondary|Changes in Self-reported Physical Activity Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|The Modifiable Activity Questionnaire (MAQ) was designed by Dr. Kriska. It has been used to assess activity in a variety of populations and age groups over various time frames and was used to assess physical activity levels in the DPP. The MAQ includes both a leisure and an occupational activity section since the homogeneity of energy expenditure related to both of these components of activity within many study populations cannot be assumed. In addition, the MAQ was designed to be modified, based upon pilot testing, prior to its usage, in order to maximize the feasibility and appropriateness of the physical activity instrument to the population of interest. The MAQ has been shown to be both reliable and valid (through comparisons with activity monitors, fitness (field) testing, and the doubly labeled water technique) in adults and adolescents alike. The MAQ has been used to assess a variety of time frames from past year and past week to a lifetime of activity.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.|||MET-hrs leisure activity||Inter-Quartile Range|Median
2726328|NCT01050205|Secondary|Changes in Waist Circumference Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|The participant was asked stand with feet together. The waist was measured using a cloth measuring tape around the abdomen. The midpoints were marked horizontally at midpoint between highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line. Both sides of the waist were marked using a cosmetic pencil. The participant was asked to have arms at side and to breathe in, out and hold, and then the measurement was taken. Waist measurement was recorded to the nearest quarter inch. The measure was repeated twice. If waist measures differ by more than one-half inch, a third measurement was recorded.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.|||inches||Standard Deviation|Mean
2726329|NCT01050205|Secondary|Changes in Systolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff's sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mmHg||Standard Deviation|Mean
2726352|NCT01050062|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey|||Patients|||Number
2726330|NCT01050205|Secondary|Changes in A1c Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers. A1c is a measure of glucose control over approximately an 8 to 12 week period.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2726331|NCT01050205|Secondary|Changes in Fasting Lipids (LDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
2726332|NCT01050205|Secondary|Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
2726333|NCT01050205|Secondary|Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Inter-Quartile Range|Median
2726334|NCT01050205|Secondary|Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the work site and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
2726335|NCT01050205|Secondary|Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
2726412|NCT01049360|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)||0 to 12 hours post-dose on Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1|||Liters||Standard Error|Least Squares Mean
2726336|NCT01050205|Secondary|Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
2726337|NCT01050205|Primary|Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Weight was measured twice using a digital physician's scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.|||Pounds||Standard Deviation|Mean
2726338|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Protein C|Study day five.||||percentage of activity||Standard Error|Mean
2726339|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti-thrombin III|Study day five.||||percentage of activity||Standard Error|Mean
2726340|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Fibrinogen|Study day five.||||mg/dL||Standard Error|Mean
2726341|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti Xa|Study day five.||||IU/mL||Standard Error|Mean
2726342|NCT01050153|Secondary|TEG Parameters|"Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).~The absolute SEMS of the sample can be calculated from MA as follows:~G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA."|Study day five.||||Kd/sc||Standard Error|Mean
2726343|NCT01050153|Secondary|Platelet Count|Platelet count measured by CBC test|Study day five.||||* 10^3 platelets/µL||Standard Deviation|Mean
2726344|NCT01050153|Secondary|International Normalized Ratio (INR)|Plasma based conventional coagulation testing parameters|Study day five.||||ratio||Standard Error|Mean
2726345|NCT01050153|Secondary|TEG Parameters|"R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).~Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.~Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).~Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.~MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets."|Study day five.||||Minutes||Standard Error|Mean
2726346|NCT01050153|Primary|Incidence of VTE|The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)|Day 28 or discharge, whichever comes first.||||participants|||Number
2726347|NCT01050153|Primary|Hypercoagulability|To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.|Study day five.|The reason for having 21 participants in the Control group and 18 participants in the TEG-guided group is that 21 and 18 participants in the respective groups stayed five days or longer. Four participants (25-21) in the Control group and seven participants (25-18) in the TEG-guided group stayed less than five days.|||participants|||Number
2726348|NCT01050062|Secondary|Blood Pressure Normalised Rate|The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||percentage of participants|||Number
2726349|NCT01050062|Secondary|Target Blood Pressure Achievement Rate|The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||Percentage of patients|||Number
2726350|NCT01050062|Secondary|Diastolic Blood Pressure (DBP)|DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||mmHg||Standard Deviation|Mean
2726353|NCT01049984|Secondary|Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater|"Site raters were asked: Considering your total clinical experience with the particular population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 0=not assessed, 1= normal, not at all ill, and 7= among the most extremely ill of patients.~Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|Day 0 (baseline), Week 18|Modified intent to treat|||participants|||Number
2726354|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant|CGI is used by the participant to rate his/her total improvement during the study. Specifically, participants are asked to compare their condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).|18 weeks|Modified intent to treat|||participants|||Number
2726355|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater|"CGI is used by the site rater to rate participants total improvement during the study whether or not, in the investigators' judgment, it is due entirely to drug treatment. Specifically, site raters are asked to compare the participants condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).~Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|18 weeks|Modified intent to treat|||participants|||Number
2726356|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, the third of which is reported in this outcome. Part III is a clinician's evaluation of motor function. Part III contains 14 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-56. Negative change from baseline values indicate improvement.~All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits"|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale III, and therefore that subscale was set as missing.|||units on a scale||Standard Error|Least Squares Mean
2726357|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living|The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. UPDRS contains four parts, the second of which is reported in this outcome. Part II is the participants' evaluation of the disease's impact on normal activities. Part II contains a total of 13 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-52. Negative change from baseline values indicate improvement.|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale II, and therefore that subscale was set as missing.|||units on a scale||Standard Error|Least Squares Mean
2726358|NCT01049984|Primary|Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement.~All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits."|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment; therefore the total UPDRS for these participants was set as missing.|||units on a scale||Standard Error|Least Squares Mean
2726359|NCT01049945|Secondary|Overall Survival (Phase II)|The overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. The overall survival rate at 6 months is defined as the percentage of participants who are alive at 6 months.|at 6 months||||percentage of participants||95% Confidence Interval|Number
2726360|NCT01049945|Secondary|Progression Free Survival (Phase II)|The progression-free survival time is defined as the time from registration to disease progression (PD=Increase of > 25% from lowest response value in Serum/Urine M-component) while receiving bendamustine, lenalidomide, and dexamethasone or death due to any cause, whichever comes first. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Treatment response was assessed using the International Myeloma Working Group uniform criteria.|Up to 2 years from study completion||||months||95% Confidence Interval|Median
2726361|NCT01049945|Secondary|Event Free Survival (Phase II)|The event-free survival time is defined as the time from registration to disease progression (PD=Increase of > 25% from lowest response value in Serum/Urine M-component) while receiving bendamustine, lenalidomide, and dexamethasone, death due to any cause, or subsequent treatment for multiple myeloma. The distribution of event-free survival will be estimated using the method of Kaplan-Meier. Treatment response was assessed using the International Myeloma Working Group uniform criteria.|Up to 2 years from study completion||||months||95% Confidence Interval|Median
2726362|NCT01049945|Secondary|Duration of Response (DOR) (Phase II)|DOR is the time from the date the patient's objective status is first noted to be PR or better to the earliest date of progression (PD=Increase of > 25% from lowest response value in Serum/Urine M-component) is documented. Treatment response was assessed using the International Myeloma Working Group uniform criteria. Complete response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent complete response (sCR)=A CR plus normal FLC ratio and no clonal cells in bone marrow. Near complete response (nCR)=A CR, with the persistence of original monoclonal protein. Very good partial response (VGPR) =Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h, Partial response (PR)=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.|Up to 2 years from study completion||||months||95% Confidence Interval|Median
2726363|NCT01049945|Primary|Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).|"Complete response (CR)~- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow~Near complete response (nCR) A CR, with the persistence of original monoclonal protein~Very good partial response (VGPR)~- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h~Partial response (PR)~≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.~a ≥50% decrease in the difference between involved and uninvolved FLC levels~or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline."|Up to 6 cycles of treatment|All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.|||percentage of participants||95% Confidence Interval|Number
2726364|NCT01049945|Primary|Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)|"The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:~Grade 2 neuropathy with pain~Any grade 3 Non-Hematologic toxicity~Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.~Grade 4 neutropenia~Febrile neutropenia~Grade 4 thrombocytopenia~Grade 3 thrombocytopenia associated with bleeding~Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.~We are reporting the results of this endpoint as the number of DLTs per dose level."|One cycle of treatment|All participants registered to the Phase I portion of this study were evaluable for this endpoint.|||Dose Limiting Toxic Events|||Number
2726365|NCT01049802|Secondary|NIH Stroke Scale|"A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale~15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity~Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment~Scores range from 0 - 42. Higher scores indicate greater severity.~Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):~Very Severe: >25~Severe: 15 - 24~Mild to Moderately Severe: 5 - 14~Mild: 1 - 5"|Screening, baseline, post treatment, 1 month, 6 months|1 data point missing from treatment arm at 6 month|||units on a scale||Standard Deviation|Mean
2726366|NCT01049802|Secondary|Chedoke Arm Assessment|A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.|Screening, baseline, weekly, post treatment, 1 month, 6 months|1 data point is missing in treatment arm at 6 month post|||units on a scale||Standard Deviation|Mean
2726367|NCT01049802|Secondary|Stroke Impact Scale|"The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure~8 domains assessed:~Strength (4 items)~Hand function (5 items)~ADL/IADL (10 items)~Mobility (9 items)~Communication (7 items)~Emotion (9 items)~Memory and thinking (7 items)~Participation/Role function (8 items)~Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item~Summative scores are generated for each domain, scores range from 0-100"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm a 6 months|||units on a scale||Standard Deviation|Mean
2726368|NCT01049802|Secondary|Action Research Arm Test|"The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:~3: Performs test normally~2: Completes test, but takes abnormally long or has great difficulty~1: Performs test partially~0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm at both 1 week and 6 month follow-up|||units on a scale||Standard Deviation|Mean
2726369|NCT01049802|Primary|Upper Extremity Fugl-Meyer Score|Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)|Baseline, post treatment, 1 month, 6 months|6 month outcome is the primary endpoint. 1 data point is missing from the treatment arm at 6 month follow up.|||units on a scale||Standard Deviation|Mean
2726370|NCT01049776|Secondary|To Describe the Clinical Toxicity Profile of Pazopanib in This Particular Patient Population||after the first 6 patients and quarterly|||||||
2726438|NCT01049217|Other Pre-specified|Sitting Heart Rate||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||beats per minute (bpm)||Standard Deviation|Mean
2726371|NCT01049776|Primary|Proportion of Non Small Cell Lung Cancer Participants With Disease Control (Complete Response+Partial Response+Stable Disease) Based on RECIST 1.0 Measured by CT or MRI|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started|12 weeks||||Proportion of participants||95% Confidence Interval|Number
2726372|NCT01049581|Secondary|Subscale on Cerebral Palsy Quality of Life Questionnaire for Children|This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation|3months||||units on a scale||Standard Error|Mean
2726373|NCT01049581|Secondary|Daily Living Subscale of Vineland Adaptive Behavior Scale|Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.|3 months||||units on a scale||Standard Deviation|Mean
2726374|NCT01049581|Primary|Unit on Gross Motor Function Measure Scale (GMFM)|The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy|3 months|complete the study and examination|||units on a scale||Standard Deviation|Mean
2726375|NCT01049503|Secondary|Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used|The lesions' progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth).|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.|||progressed lesions/child||Standard Deviation|Mean
2726376|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.|||lesions/child||Standard Deviation|Mean
2726377|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.|||lesions/child||Standard Deviation|Mean
2726378|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.|Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Buzalaf et al. (2009). From the trial participants in the fluoridated area, a convenience sample of 161 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.|||µgF/g||Standard Deviation|Mean
2726379|NCT01049503|Secondary|Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.|||regressed lesions/child||Standard Deviation|Mean
2726390|NCT01049412|Secondary|Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 8 (Period I)|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2726573|NCT01047839|Primary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination|Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.|until Day 56||||percentage of participants||95% Confidence Interval|Number
2726380|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.|||progressed lesions/child||Standard Deviation|Mean
2726381|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.|Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Pessan et al. (2008). From the trial participants in the fluoridated area, a convenience sample of 47 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.|||mmol/kg||Standard Deviation|Mean
2726382|NCT01049412|Secondary|Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint|Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day between Week 6 and Week 8. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
2726383|NCT01049412|Secondary|Rate of Hypoglycemia Per 30 Days Baseline Through Week 8|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]. Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.|Baseline through Week 8 of each treatment period|All randomized participants who took at least one dose of study drug.|||number of hypoglycemia episodes/30 days||Standard Deviation|Mean
2726384|NCT01049412|Secondary|Percentage of Participants With Hypoglycemia Baseline Through Week 8|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole per Liter (mmol/L) (≤70 milligram per deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005].|Baseline through Week 8 of each treatment period|All randomized participants who took at least one dose of study drug.|||percentage of participants|||Number
2726385|NCT01049412|Secondary|Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20|Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative.|Week 8, Week 16 and Week 20|All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements.|||percentage of participants|||Number
2726386|NCT01049412|Secondary|Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint|The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches.|Week 8 of each treatment period|Participants who took at least one dose of study drug and had measurements at Week 8.|||picomoles per liter (pMol/L)||Geometric Coefficient of Variation|Geometric Mean
2726387|NCT01049412|Secondary|Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint|LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Week 2 and Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with at least one non-missing value of the response variable at any of the subsequent weeks.|||nanomoles per kilogram (nmoles/kg)||Standard Deviation|Least Squares Mean
2726388|NCT01049412|Secondary|8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint|8-point SMBG profiles are measured at morning fasting BG (FBG), midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
2726389|NCT01049412|Secondary|Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Week 8 (Period I)|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2726391|NCT01049412|Secondary|Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline to 8-week at Period I is from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; interaction between visit and treatment; and a random effect for participant.|Baseline, Week 8 (Period I)|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
2726392|NCT01049412|Secondary|Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles|It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. LS mean of daily Avg. BG is from MMRM, which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; a random effect for participant.|Baseline, Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
2726393|NCT01049412|Primary|Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles|It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin [HbA1c] group); visit; visit and treatment interaction; a random effect for participant.|Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||millimole per Liter (mmol/L)||Standard Error|Least Squares Mean
2726394|NCT01049373|Secondary|Number of ADRs|frequency of ADR with a probable or possible causal relationship|within 15 weeks treatment||||adverse reactions|||Number
2726395|NCT01049373|Secondary|Number of Days With Incapability to Work||15 weeks treatment|||||||
2726396|NCT01049373|Secondary|Amount of Analgesics Used||15 weeks treatment|||||||
2726397|NCT01049373|Secondary|Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)||following 15 weeks treatment|||||||
2726398|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12) Ment||following 15 weeks treat|||||||
2726399|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12)||following 2 weeks treatment|||||||
2726400|NCT01049373|Secondary|Change in Oswestry Score||following 15 weeks treatment|||||||
2726401|NCT01049373|Secondary|Change in Oswestry Score||following 2 weeks treatment|||||||
2726402|NCT01049373|Secondary|Change in State of Health (BF-S)||following 15 weeks treatment|||||||
2726403|NCT01049373|Secondary|Change in State of Health (BF-S)||following 2 weeks treatment|||||||
2726404|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 15 weeks treatment|||||||
2726405|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 2 weeks treatment|||||||
2726406|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.~Difference between screening and 15 weeks in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 15 weeks treatment|Only patients with assessable values at present time point were analyzed.|||units on a scale||Standard Deviation|Mean
2726407|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.~Difference between V1 minus V-1 in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 2 weeks treatment|Only patients with assessable values at present time point were analyzed.|||units on a scale||Standard Deviation|Mean
2726408|NCT01049373|Secondary|Change in FFbH-R Between Screening and 2 Weeks|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.~Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best)"|between screening and 2 weeks treatment|ITT|||units on a scale||Standard Deviation|Mean
2726409|NCT01049373|Primary|Change in FFbH-R Between Screening and Week 15|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.~Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)"|between screening and 15 weeks treatment|ITT|||units on a scale||Standard Deviation|Mean
2726410|NCT01049360|Secondary|Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1|||Liters||Standard Error|Least Squares Mean
2726411|NCT01049360|Secondary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1|||Liters||Standard Error|Least Squares Mean
2726413|NCT01049334|Secondary|Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement Duration of Relief Using Participant-Defined Definite Improvement Levels (DIL)|"As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial.~The time of first achieving DIL for 30 minutes within 6 hours (or until rescue or re-dosing) post-dosing will be determined. And the time falling below DIL within 6 hours will be determined. Duration is then defined as the time from first DIL until falling below DIL. Duration was set to zero if the STPIS score does not reach the DIL for at least 30 minutes for STPIS during the 6 hours."|6 hours|Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.|||minutes||Standard Deviation|Mean
2726414|NCT01049334|Secondary|Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement|"As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial.~An alternative definition of STPIS time to onset of relief was the time from initial dose to the time the participant reaching DIL for at least 30 minutes. Data were censored if DIL was not achieved by 120 minutes following initial dose. Definite improvement must also occur prior to re-dosing or using rescue medication."|2 hours|Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.|||minutes||95% Confidence Interval|Median
2726415|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05|"Data reported in summary form in Primary Outcome #1 are reported here at each post-dose timepoint until the comparison resulted in a P-value <=0.05 between the two treatment arms.~STPIS was used to measure sore throat pain intensity using a 100-mm visual analog scale completed by participants that measures pain on swallowing (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. The full range of the scale varies by timepoint due to the time weighting sum of SPID. The full scale at 40 minutes post dose was -3188 (complete pain relief within 2 minutes of dosing that lasts 40 minutes) to 812 (maximum pain within 2 minutes lasting 40 minutes) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (rec"|baseline (pre-dose), up to 23 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-23)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
2726416|NCT01049334|Secondary|Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose|"Participants used a 6-category relief scale (no relief to complete relief) to grade the relief of his/her throat pain.~The patient was instructed to swallow and:~Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now."|2 hours|Intent to treat population of participants who had a 2 hour assessment.|||percentage of participants|||Number
2726417|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -116196 (no pain at any post-dose time (0) - average baseline) to 27804 (maximum possible pain (100) - average baseline).~Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication (acetaminophen 650mg was allowed as needed), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation."|baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)|Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.|||units on a scale||Standard Deviation|Mean
2726418|NCT01049334|Secondary|Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)|"Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of the study by answering the following question: Considering the patient's response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent."|Day 7|Intent to treat population of participants who had an end of study assessment.|||percentage of participants|||Number
2726419|NCT01049334|Secondary|Participant Satisfaction Scores 24 Hours After Initial Dose|After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.|24 hours|Intent to treat population. Three participants withdrew before the 24 hour assessment.|||percentage of participants|||Number
2726420|NCT01049334|Secondary|Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose|"Investigators assessed the effectiveness of study medication on the patient's sore throat at 24 hours following initial dose by answering the following question: Considering the patient's response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent."|24 hours|Intent to treat population. Three participants withdrew before the 24 hour assessment.|||percentage of participants|||Number
2726421|NCT01049334|Secondary|Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose|P.A.I.N is a four step scale in which physicians rate the severity of pharyngeal inflammation: No inflammation, mild, moderate and severe inflammation.|24 hours post-dose|Intent to treat population. Three participants withdrew before the 24 hour assessment.|||participants|||Number
2726422|NCT01049334|Secondary|Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8|"Tonsillo-Pharyngitis Assessment, or TPA, is an index of seven clinical features of the pain-producing condition itself, pharyngeal inflammation. The clinical features concern temperature, oropharyngeal color, size of tonsils, number of enanthems, largest size of cervical lymph node, number of lymph nodes, and maximum tenderness of lymph nodes. Each variable was rated on a scale of 0-3, with 0 representing the normal value, and 3 representing severe inflammation. The seven values are added together to create the TPA, ranging from 0-21.~Negative change values represent improvement of symptoms."|Baseline (pre-dose), 24 hours post-dose|Intent to treat population of participants whose baseline TPA was >=8 and had an assessment at hour 24.|||units on a scale||Standard Deviation|Mean
2726423|NCT01049334|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline|"The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and specified timeframes until 24 hours.~The patient was instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -112032 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31968 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS."|baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours)|Intent to treat population of participants who took the first full dose of medication, and had SwoTS recorded after 21 hours. Four participants (1 Flurbiprofen, 3 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2726424|NCT01049334|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline|"The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours.~The patient was instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9336 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2664 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS."|baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
2726425|NCT01049334|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline|"Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and until 24 hours post dose.~Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -110304 (no difficulty swallowing within 10 minutes of dosing that lasts 24 hours) to 33696 (maximum difficulty swallowing within 10 minutes lasting 24 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)|Intent to treat population of participants who took the first full dose of medication and had DSS recorded after 21-hours.|||units on a scale||Standard Deviation|Mean
2726426|NCT01049334|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline|"Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and 2 hours post dose.~Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9192 (no difficulty swallowing within 10 minutes of dosing that lasts 2 hours) to 2808 (maximum difficulty swallowing within 10 minutes lasting 2 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
2726427|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dosing. The full range was -9405 (complete pain relief within 2 minutes of dosing that lasts 2 hours) to 2395 (maximum pain within 2 minutes lasting 2 hours) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
2726471|NCT01048879|Primary|Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance|Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).|12 hours|One patient in the CVVHD Alone group was excluded from the analysis because not enough data points were available for pharmacokinetic modeling.|||mL/min||Standard Deviation|Mean
2726472|NCT01048866|Secondary|Change From Baseline in Body Temperature at End of Study||baseline (pre-dose), up to Day 7|Safety population of participants with a recording at the end of study visit.|||degrees Fahrenheit||Standard Deviation|Mean
2726428|NCT01049334|Primary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)|STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time-weighted pain intensity differences from baseline until 24 hours. The full range was -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.|baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)|Intent to treat population of participants who took the first full dose of medication. Three participants (1 Flurbiprofen, 2 Placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint (no entries after 2 hours), but did have sufficient data to be included in other efficacy analyses.|||units on a scale||Standard Error|Least Squares Mean
2726429|NCT01049308|Secondary|Medication Adherence|"To capture both overtaking and undertaking medication, a delta was determined for each medication by computing the absolute difference between the number of pills taken and the number prescribed over the 30-day period. The delta values for each medication were summed for each individual subject, divided by the total number of pills prescribed, subtracted from 1, and finally multiplied by 100 to obtain an adherence score expressed as a percentage."|30 days||||percentage of adherence||95% Confidence Interval|Mean
2726430|NCT01049308|Primary|SLUMS Scores|SLUMS (Saint Louis University Mental Status) exam is a validated screening test for cognitive impairment (CI) consisting of 30-point interview scale. SLUMS is considered positive for mild CI if the score is <27 in a person with a high school diploma or <25 in a person who did not complete high school. SLUMS screening is considered positive for severe impairment consistent with dementia if the score is <21 for persons with a high school diploma and <20 for persons who did not complete high school.|baseline collection||||scores on a scale||Standard Deviation|Mean
2726431|NCT01049243|Secondary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.|Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.|Baseline to 14 days||||units on a scale||95% Confidence Interval|Mean
2726432|NCT01049243|Primary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.|Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.|Baseline to 3 days||||Scores on a scale||Standard Deviation|Mean
2726433|NCT01049217|Secondary|Diagnostic Neuropathy Assessment||Screening|Data were not collected since this was a screening tool for investigators and there was no analysis planned for this measure.||||||
2726434|NCT01049217|Other Pre-specified|Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)|"PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated Over past 2 weeks, how often bothered by any of following problems?: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity."|Screening|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||participants|||Number
2726435|NCT01049217|Other Pre-specified|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Screening, Post-Baseline (Week 4 up to Week 17)|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||participants|||Number
2726436|NCT01049217|Other Pre-specified|Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria|MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.|Screening|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2726437|NCT01049217|Other Pre-specified|Number of Participants With Neurological Examination Findings|A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities [LE], right and left first metatarsal joint position sense, and vibration sensation [vibration is felt for < 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, > 10 seconds = normal]).|Screening|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.|||participants|||Number
2726473|NCT01048866|Secondary|Change From Baseline in Body Temperature at 2 Hours Post Initial Dose||baseline (pre-dose), 2 hours post-dose|Safety population|||degrees Fahrenheit||Standard Deviation|Mean
2726439|NCT01049217|Other Pre-specified|Sitting Systolic and Diastolic Blood Pressure|Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.|Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2726440|NCT01049217|Other Pre-specified|Body Weight||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||kilogram||Standard Deviation|Mean
2726441|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.|Screening, Week 8, 17|Safety population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group.|||participants|||Number
2726442|NCT01049217|Other Pre-specified|Number of Participants With Positive Serum and Urine Pregnancy|Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.|Screening for serum pregnancy test, Week 1 for urine pregnancy test|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2726443|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.|Screening up to Week 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2726444|NCT01049217|Other Pre-specified|Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.|||participants|||Number
2726445|NCT01049217|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2726446|NCT01049217|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||hours||Standard Deviation|Mean
2726447|NCT01049217|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|"WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded Yes/No to Question 1: Are you currently employed (working for pay)? are reported."|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||participants|||Number
2726474|NCT01048866|Secondary|Time to First Rescue Pain Medication|Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment during the study. Time from initial dose to first rescue medication is summarized by time categories.|Days 1-7|Intent to treat population|||percentage of participants|||Number
2726475|NCT01048866|Secondary|Percentage of Participants Who Took Rescue Pain Medication|Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.|Days 1-7|Intent to treat population|||percentage of participants|||Number
2726448|NCT01049217|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726449|NCT01049217|Secondary|Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726450|NCT01049217|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||participants|||Number
2726451|NCT01049217|Secondary|Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726452|NCT01049217|Secondary|Percentage Day Time Above Sedentary Level|"Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (>) 200 activity counts per minute divided by total number of epochs during the day (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method."|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||percentage of day time||Standard Error|Least Squares Mean
2726453|NCT01049217|Secondary|Total Activity Counts|"Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method."|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||activity counts per day||Standard Error|Least Squares Mean
2726454|NCT01049217|Secondary|Sleep Efficiency|Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||Percent time between sleep onset and end||Standard Error|Least Squares Mean
2726503|NCT01048658|Secondary|Patient and Provider Satisfaction With Anesthesia|Scores reported on 10-cm Visual Analog Scale (VAS anchors: 0= not satisfied at all, 10= completely satisfied) . Reported as mean +/- standard deviation. Subjects and providers were blinded to anesthesia method. Subjects and providers completed post-operative questionnaire within 30 minutes of procedure completion.|Post-procedure, within 30 minutes||||cm||Standard Deviation|Mean
2726455|NCT01049217|Secondary|Sleep Fragmentation Index (SFI)|SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||percentage of immobile bouts||Standard Error|Least Squares Mean
2726456|NCT01049217|Secondary|Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)|Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||minutes||Standard Error|Least Squares Mean
2726457|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726458|NCT01049217|Secondary|Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours [hrs], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||participants|||Number
2726459|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726460|NCT01049217|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)|BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.|Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726461|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|"Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current (right now) HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method."|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726462|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2726463|NCT01049217|Secondary|Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)|The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2726464|NCT01049217|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2726465|NCT01049217|Primary|Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).|Baseline, Endpoint (up to Week 16)|Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2726466|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|24 weeks||||mL/100 mL/min||Standard Deviation|Mean
2726467|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|12 weeks||||mL/100 mL/min||Standard Deviation|Mean
2726468|NCT01048944|Primary|Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence|"Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal craving and psychological symptom scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from 5 = (no craving) to 47 (maximally strong craving), while that for psychological symptoms is from 5 (no symptoms) to 60 (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of 1 is equal to an increase by a factor of 10, while a value of 0 is no change, and values of less than 0 are decreases below baseline values."|Changes in log withdrawal symptoms from baseline through 66 days of abstinence|Analysis population included only those individuals who complied fully with study requirements through 67 days of abstinence.|||log (base 10) units on a scale||Standard Error|Mean
2726469|NCT01048944|Primary|Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.|Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second [cps]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power [microvolts squared] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.|Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit|For the currently reported analyses, only individuals complying with the study requirements, including biochemically verified smoking abstinence, were assessed. Future analyses will include individuals who complied to certain critical endpoints.|||Change in log EEG [microvolts squared]||Standard Error|Mean
2726470|NCT01048879|Primary|Oseltamivir Carboxylate Removal by ECMO|Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.|12 hours|All of the patients that received ECMO were included. Patients receiving CVVHD Alone did not receive ECMO and were not included.|||percent change in concentration||Standard Deviation|Mean
2726476|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing|"Participants graded the relief of his/her sore throat at 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and:~Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now. Responses following each lozenge were no relief, slight, mild, moderate, considerable, and complete relief. Results summarize responses 2 hours after taking each lozenge."|Days 2-7|Intent to treat population of participants who were active in the study on day 2|||percentage of doses|Lozenges (doses)||Number
2726477|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)|"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.~The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose.~The patient was instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. Data for multiple doses/days were averaged to obtain the values used for calculating SWoTS2. The full range for differences was -5396 to 6604 with negative values indicating improvement in pain intensity.~Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2|||units on a scale||Standard Error|Least Squares Mean
2726478|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)|"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.~To measure the functional effect on pharyngitis, the participant was asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose. The participant was instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data for multiple doses/days were averaged to obtain the values used for calculating DSS2. The full range for differences was -5626 to 6374 with negative values indicating improvement in pain intensity.~Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.|||units on a scale||Standard Error|Least Squares Mean
2726479|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)|"The time weighted summed differences over 2 hours after taking a lozenge after the initial 24-hours post-baseline.~STPIS is a validated 100-mm visual analog scale completed by participants that measures pain on swallowing (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from a measurement taken prior to taking a lozenge and at hours 1 + 2 after taking the lozenge during Days 2-7. Data for multiple doses/days were averaged to obtain the values used for calculating SPID2. The full range for SPID2 was -5843 to 6157 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.|||units on a scale||Standard Error|Least Squares Mean
2726480|NCT01048866|Secondary|Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)|"Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of study by answering the following question: Considering the patient's response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent."|Day 7 (end of study)|Intent to treat population of participants who completed the study. CLIN was missing for one flurbiprofen participant.|||percentage of participants|||Number
2726481|NCT01048866|Secondary|Participant Satisfaction Score 24 Hours After Initial Dose|After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.|24 hours|Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score.|||percentage of participants|||Number
2726482|NCT01048866|Secondary|Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose|"Investigators assessed the effectiveness of study medication on the patient's sore throat at 24 hours following initial dose by answering the following question: Considering the patient's response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent."|24 hours|Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo).|||percentage of participants|||Number
2726483|NCT01048866|Secondary|Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose|"Participants graded the relief of his/her sore throat at 2 hours post initial dose using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and asked:~Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now. Responses were no relief, slight, mild, moderate, considerable, and complete relief."|2 hours|Intent to treat population|||percentage of participants|||Number
2726504|NCT01048658|Secondary|Number of Participants Experiencing Side Effects (Nausea, Dizziness)||Post-procedure, within 30 minutes||||Participants|||Count of Participants
2726505|NCT01048658|Secondary|Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)|Length of procedure from time of speculum placement to time of speculum removal, in minutes.|Time of speculum place to time of speculum removal, an average of 7.1 minutes||||minutes||Standard Deviation|Mean
2726484|NCT01048866|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -115695 (no pain at any post-dose time (0) - average baseline) to 28505 (maximum possible pain (100) - average baseline).~Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imput"|baseline (pre-dose), 24 hours post dose (measured each hour post dose)|Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.|||units on a scale||Standard Deviation|Mean
2726485|NCT01048866|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9492 (complete pain relief within one hour of dosing that lasts 2 hours) to 2508 (maximum pain within 1 hour lasting 2 hours) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), post-dose: 1 hour, 2 hours|Intent to treat population|||units on a scale||Standard Deviation|Mean
2726486|NCT01048866|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline|"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.~The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -100320 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31680 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. Negative values for differences indicate improvement."|Baseline (pre-dose), hourly readings to 24 hours post-dose|Intent to treat population. Four participants (2 Flurbiprofen, 2 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2726487|NCT01048866|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline|"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.~The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9120 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2880 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS.~Negative values for the differences indicate improvement. Missing values of SwoTS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), hourly readings to 2 hours post-dose|Intent to treat population of participants who took the first full dose of medication|||units on a scale||Standard Deviation|Mean
2726488|NCT01048866|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline|"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.~Data are reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -102960 (no difficulty swallowing within 1 hour of dosing that lasts 24 hours) to 29040 (maximum difficulty swallowing within 1 hour of dosing lasting 24 hours) using the baseline DSS value. Negative values indicate improvement in difficulty swallowing.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), hourly readings to 24 hours post-dose|Intent to treat population. Four participants (2 Flurbiprofen and 2 placebo) did not have DSS recorded after 21 hours and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2726489|NCT01048866|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline|"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.~Data are reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9360 (no difficulty swallowing within 1 hour of dosing that lasts 2 hours) to 2640 (maximum difficulty swallowing within 1 hour of dosing lasting 2 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), Hours 1 and 2 post-dose|Intent to treat population of participants who took the first full dose of medication|||units on a scale||Standard Deviation|Mean
2726506|NCT01048658|Secondary|Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)|Procedural blood loss greater than 300 mL. Blood loss was measured in a standardized fashion (amniotic fluid was discarded, blood was separated from tissue, and all gauze surgical drapes weighed).|At time of uterine evacuation, an average of 7.1 minutes||||Participants|||Count of Participants
2726490|NCT01048866|Primary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS.~Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), post-dose - hourly up to 24 hours|Intent to treat population of participants who took the first full dose of medication, and had STPIS values recorded >= 21 hours post initial dose. Four participants (2 Flurbiprofen, 2 placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint.|||units on a scale||Standard Deviation|Mean
2726491|NCT01048788|Primary|Body Weight|Changes in body weight from baseline at the end of administration|Baseline, Day 14 or end of administration||||Kg||Standard Deviation|Mean
2726492|NCT01048723|Secondary|Number of Participants With Memory CD8 T Cell Enhanced Production|Memory CD8 T cell enhanced production as determined by fluorescence activated cell sorter (FACS) analysis on blood and tumor core biopsy specimens taken before and after therapy with RAD001. Our planned analysis was for 40 participants.|Pre and Post the 2 week treatment|||||||
2726493|NCT01048723|Secondary|Number of Participants With Pathological Response|We planned to determine pathological response in terms of tumor necrosis and apoptosis assessed on the resected specimens after 2 weeks of RAD001 therapy. Percent necrosis was to be reported based on the routine H and E staining. In addition to cleaved PARP analysis, TUNEL assays were to be performed judging the amount of apoptosis in the specimens after treatment. Our planned analysis was for 40 participants.|Post the 2 week treatment|||||||
2726494|NCT01048723|Secondary|PD Markers (p70S6K, S6-RP, P-AKT, Cleaved PARP and PCNA)|Quantitative in vivo and ex vivo assessments of PD markers (p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA) were to be normalized within the same sample. The extent of inhibition is defined as the fractional inhibition in each patient calculated as [(PreRx normalized PD marker - PostRx normalized PD marker) / PreRx normalized PD marker] x 100. Same definition would apply to each of these markers. Our planned analysis was for 40 participants.|Post the 2 week treatment|||||||
2726495|NCT01048723|Primary|Pharmacodynamics (PD) Markers|PD markers of RAD001 on downstream signaling pathways in patients with sarcomas: p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA by Western blot, quantitative multiplex assays and immunohistochemical studies measured pre and post the 2 week treatment of RAD001. Patients were to be separated into two groups, responders and non responders based on PD results and downstream up regulation of the referenced pathways. Mean fractional inhibition of each PD marker for the responding and non-responding groups were to be calculated. Our planned analysis was for 40 participants.|Pre and post the 2 week treatment|||||||
2726496|NCT01048697|Primary|Total Clearance of Ethambutol||Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)||||L/h||Standard Deviation|Mean
2726497|NCT01048671|Secondary|Number of Participants With at Least One Adverse Event|An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product.|Up to 25 months after start of raltegravir treatment|Participants enrolled and not excluded for a protocol violation were included in the analysis.|||Participants|||Number
2726498|NCT01048671|Primary|Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||cells/mm^3||95% Confidence Interval|Mean
2726499|NCT01048671|Primary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||cells/mm^3||95% Confidence Interval|Mean
2726500|NCT01048671|Primary|Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||Percentage of participants||95% Confidence Interval|Number
2726501|NCT01048671|Primary|Percentage of Participants Responding to Treatment: All Treated Participants|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||Percentage of participants||95% Confidence Interval|Number
2726502|NCT01048671|Primary|Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.|Up to 25 months after start of raltegravir treatment|Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.|||Percentage of participants|||Number
2726507|NCT01048658|Primary|Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)|Provider report for need to intervene due to blood loss (yes/no)|At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes||||Participants|||Count of Participants
2726508|NCT01048606|Secondary|Physical Capacity: 3 Tests From the Senior Fitness Test (Chair Stand Test, Chair Sit-and-Reach Test, Back Scratch Test) + Handgrip Strength Test (Lafayette Hand Dynamometer, Indiana)||0, 6 and 12 months|||||||
2726509|NCT01048606|Secondary|Maximal Oxygen Uptake Measured Using a Continuous, Incremental Protocol (Balke Modified Protocol) on a Treadmill With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA).||0 and 12 months|||||||
2726510|NCT01048606|Secondary|Metabolic Rate at Rest: During 30 Minutes With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA) After a 12-hour Fast, in the Early Morning.||0, 6 and 12 months|||||||
2726511|NCT01048606|Secondary|Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method||0, 6 and 12 months|||||||
2726512|NCT01048606|Secondary|Physical Activity Level: Physical Activity Scale for the Elderly (PASE)||0, 6 and 12 months|||||||
2726513|NCT01048606|Secondary|Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval)||0, 6 and 12 months|||||||
2726514|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||12 months|||||||
2726515|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||6 months|||||||
2726516|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||12 months|||||||
2726517|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||6 months|||||||
2726518|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||12 months|||||||
2726519|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||6 months|||||||
2726520|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||Baseline|||||||
2726521|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||12 months|||||||
2726522|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||6 months|||||||
2726523|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||12 months|||||||
2726524|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||6 months|||||||
2726525|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||12 months|||||||
2726526|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||6 months|||||||
2726527|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||12 months|||||||
2726528|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||6 months|||||||
2726529|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||Baseline|||||||
2726530|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale.||Baseline|||||||
2726531|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||Baseline|||||||
2726532|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||Baseline|||||||
2726533|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||Baseline|||||||
2726534|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||Baseline||||percent of total fat mass||Standard Deviation|Mean
2726535|NCT01048593|Secondary|Anterior Chamber Cell Grade|Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.|Day 90 post-treatment||||Participants|||Count of Participants
2726536|NCT01048593|Secondary|Corneal Edema Grade|Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.|Day 90 post-treatment||||Participants|||Count of Participants
2726537|NCT01048593|Secondary|Conjunctival Erythema Grade|Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.|Day 90 post-treatment||||Participants|||Count of Participants
2726538|NCT01048593|Secondary|Anterior Chamber Flare (ACF) Grade|Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.|Day 90 post-treatment||||Participants|||Count of Participants
2726539|NCT01048593|Primary|Clearance of Anterior Chamber Cells|Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.|Day 8 post treatment||||Participants|||Count of Participants
2726540|NCT01048541|Secondary|Median Absolute RU Volume||3 catheterisations on 1 day|||||||
2726541|NCT01048541|Secondary|The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)||Study period|||||||
2726546|NCT01048424|Secondary|Change in Sleep Quality|The Pittsburgh Sleep Quality Index. A global sleep quality score derived from the PSQI can be used to index overall quality of sleep over the prior one-week period. Global sleep quality scores are continuous (range 0-21), with high scores reflecting poor sleep quality.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
2726547|NCT01048424|Secondary|Change in Perceived Stress|Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
2726548|NCT01048424|Secondary|Change in Depression Symptoms|Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
2726549|NCT01048424|Secondary|Change in Anxiety Symptoms|Hospital Anxiety and Depression Scale. Anxiety Subscale range from 0 to 21, with scores of less than 8 indicative of absence of anxiety symptoms, 8 or above suggesting anxiety symptoms, and 12 or above suggesting generalized anxiety disorder.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
2726550|NCT01048424|Secondary|Change in Overactive Bladder Symptoms|The Overactive Bladder Questionnaire (OAB-Q). 0- to 100-point scale. Higher scores on the OAB-Q indicate greater bothersomeness and impact of overactive bladder symptoms.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
2726551|NCT01048424|Secondary|Percent Change in Daytime Voiding Frequency.|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks||||Percent Change||Standard Deviation|Mean
2726552|NCT01048424|Secondary|Percent Change in Any Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks||||Percent Change||Standard Deviation|Mean
2726553|NCT01048424|Primary|Percent Change in Urgency Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|baseline to 6 weeks||||Percent Change||Standard Deviation|Mean
2726554|NCT01048333|Secondary|Adverse Events|Number of participants with at least 1 AE.|At baseline and at each day of treatment||||Participants|||Number
2726555|NCT01048333|Secondary|Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1|Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1|Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose||||Percentage of Participants|||Number
2726556|NCT01048333|Secondary|Average FEV1 During 120 Minutes Post Dose|Average FEV1 during 120 minutes post dose, change versus pre dose FEV1|Pre dose and 120 minutes post dose||||percentage change||95% Confidence Interval|Geometric Mean
2726557|NCT01048333|Secondary|Average FEV1 During the First 15 Minutes Post Dose|Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1|Pre dose and 15 minutes post dose||||percentage change||95% Confidence Interval|Geometric Mean
2726558|NCT01048333|Primary|FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose|FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1|Pre-dose and 5 minutes post-dose||||percentage change||95% Confidence Interval|Geometric Mean
2726559|NCT01048242|Primary|Sleep Onset Latency|Time to sleep onset as determined by polysomnography|4 weeks|analysis per protocol|||minutes||Standard Deviation|Mean
2726560|NCT01048125|Primary|Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.||2 years|Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.||||||
2726561|NCT01048099|Primary|Part II: Objective Response Rate of Pertuzumab Therapy|The percentage of patients with HER2 activation (no overexpression) as identified by the PRO Onc Assay who experience an objective benefit from treatment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes patients with only HER2 activation (no overexpression) as detected by the PRO Onc Assay|||percentage of participants|||Number
2726562|NCT01048099|Primary|Part II: Objective Response Rate of Trastuzumab Therapy|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression as identified by the PRO Onc Assay.|18 months|Includes patients with HER2 overexpression detected by the PRO Onc Assay|||percentage of participants|||Number
2726563|NCT01048099|Secondary|Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens|Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.|12 months|Includes all patients with blood drawn and analyzed for CTCs|||percentage of participants|||Number
2726564|NCT01048099|Primary|Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)|The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression/activation as detected by PRO Onc Assay.|18 months||||percentage of participants|||Number
2726565|NCT01048099|Secondary|Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay|Includes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.|12 months||||participants|||Number
2726566|NCT01047839|Secondary|SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups||at Day 56 and Month 7|||||||
2726567|NCT01047839|Secondary|GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7||at Day 56 and Month 7|||||||
2726574|NCT01047709|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The relative treatment effect on AHI using GEE modeling.|1 day||||events/hr||Inter-Quartile Range|Median
2726575|NCT01047553|Secondary|St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
2726576|NCT01047553|Secondary|Use of SABA (Salbutamol) as Reliever Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Times/Day||Standard Deviation|Mean
2726577|NCT01047553|Secondary|Number of COPD Exacerbations Over the Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment was presented here.|Daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||number of exacerbations|||Number
2726578|NCT01047553|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
2726579|NCT01047553|Secondary|Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
2726580|NCT01047553|Secondary|Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
2726581|NCT01047553|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Median
2726582|NCT01047553|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Liter/minute (L/min)||Standard Deviation|Mean
2726583|NCT01047553|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Liter/minute (L/min)||Standard Deviation|Mean
2726584|NCT01047553|Secondary|Forced Vital Capacity (FVC)|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Percentage of baseline||Full Range|Geometric Mean
2726730|NCT01046136|Secondary|Number of Patients With Adverse Events|Total number of patients with adverse events that were possibly or probably related.|7 days|All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused.|||participants|||Number
2726585|NCT01047553|Secondary|Forced Expiratory Volume in One Second (FEV1)|The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||percentage of baseline||Full Range|Geometric Mean
2726586|NCT01047553|Primary|ECG Variables RR Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
2726587|NCT01047553|Primary|ECG Variables QTcF Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
2726588|NCT01047553|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
2726589|NCT01047553|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
2726590|NCT01047553|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||beats/min||Standard Deviation|Mean
2726591|NCT01047553|Primary|Vital Signs - Pulse Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||beats/minute||Standard Deviation|Mean
2726592|NCT01047553|Primary|Vital Signs- Sitting DBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mmHg||Standard Deviation|Mean
2726593|NCT01047553|Primary|Vital Signs- Sitting SBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mmHg||Standard Deviation|Mean
2726594|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dl||Standard Deviation|Mean
2726595|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Protein|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||g/dl||Standard Deviation|Mean
2726596|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Albumin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||g/dl||Standard Deviation|Mean
2726597|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S- Calcium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dl||Standard Deviation|Mean
2726598|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Potassium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mEq/L||Standard Deviation|Mean
2726599|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Sodium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mEq/l||Standard Deviation|Mean
2726600|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dL||Standard Deviation|Mean
2726601|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Creatinine|Change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dL||Standard Deviation|Mean
2726602|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||U/l||Standard Deviation|Mean
2726603|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||U/l||Standard Deviation|Mean
2726604|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||U/l||Standard Deviation|Mean
2726605|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Neutrophil||Standard Deviation|Mean
2726606|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Monocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Monocyte||Standard Deviation|Mean
2726607|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Lymphocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Lymphocyte||Standard Deviation|Mean
2726608|NCT01047553|Primary|Clinical Laboratory Test: Haematology Basophil|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Basophil||Standard Deviation|Mean
2726609|NCT01047553|Primary|Clinical Laboratory Test: Haematology Eosinophils|Change from baseline|baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Eosinophil||Standard Deviation|Mean
2726610|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Platelet Count|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||Platelet Count x10000/μl||Standard Deviation|Mean
2726611|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Leucocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||leukocyte count/µL||Standard Deviation|Mean
2726612|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||g/dL||Standard Deviation|Mean
2726613|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||erythrocytes counts x10000/μl||Standard Deviation|Mean
2726614|NCT01047527|Primary|Week 24 Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|24-week|This analysis was planned to replicate the previous study (Schnoll et al., 2010; Annals of Internal Medicine).|||participants|||Number
2726615|NCT01047527|Primary|Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|52-week|The primary objective of this study was to examine the benefits in terms of cessation of 52-weeks of treatment compared to 8 or 24 weeks.|||participants|||Number
2726616|NCT01047475|Primary|The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)|The primary efficacy analysis, the incidence of best overall response during the study period, was based on the Fisher's exact test for the binary response that was used to test for the differences in the treatment efficacy between MB-6 and Placebo.|16 weeks||||percentage of Best overall Response||95% Confidence Interval|Median
2726617|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose|Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication|12 h (hours) after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h|||Percent reduction||Full Range|Median
2726618|NCT01047436|Primary|Time for Parasite Count to Fall by 50% PCT(50)|The time taken for the parasite count to fall 50% from baseline|3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h||||hours||Standard Deviation|Mean
2726619|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose|Reduction in parasitaemia from baseline at 24 h after the first dose of study medication|24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h|||Percent reduction||Full Range|Median
2726620|NCT01047436|Primary|Time for Parasite Count to Fall by 90% PCT(90)|The time taken for the parasite count to fall 90% from baseline|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h||||hours||Standard Deviation|Mean
2726621|NCT01047436|Secondary|Parasite Clearance Time|Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h||||Hours||Standard Deviation|Mean
2726622|NCT01047436|Primary|Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose||24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h (hours) or 24 h after start of treatment.|||participants|||Number
2726623|NCT01047358|Secondary|Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)|The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of the study, average of 5.6 months|Efficacy Analysis Set.|||Percentage of Participants|||Number
2726624|NCT01047358|Secondary|Time-to-Progression (Early Breast Cancer)|Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.|At the end of the study, average of 5.6 months|This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF.||||||
2726625|NCT01047358|Secondary|Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)|The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF).|At the end of the study, average of 5.6 months.|Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.|||Percentage of Participants|||Number
2726626|NCT01047358|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.|From the first dose of Aromasin through the end of the study for an average of 5.6 months|Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.|||Percentage of Participants|||Number
2726627|NCT01047345|Other Pre-specified|Percentage of Participants Who Experience an SAE- Extension Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to Month 7 - Extension Study|All participants who received at least 1 vaccination in Extension Study and had available follow-up data.|||Percentage of Participants|||Number
2726628|NCT01047345|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7; End of Base Study)|Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.|||Percentage of Participants||95% Confidence Interval|Number
2726629|NCT01047345|Primary|Percentage of Participants Who Experience a Severe Injection-site AE - Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
2726630|NCT01047345|Primary|Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study|"An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be definitely related, probably related, or possibly related is defined as a vaccine-related SAE."|Up to 7 months - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
2726631|NCT01047345|Primary|Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
2726754|NCT01045967|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2726632|NCT01047345|Primary|Percentage of Participants Who Experience a Systemic AE - Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
2726633|NCT01047345|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available temperature data.|||Percentage of Participants|||Number
2726634|NCT01047345|Primary|Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
2726635|NCT01047332|Secondary|Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism|Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.|||participants|||Number
2726636|NCT01047332|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.|From time of stent placement to participant death or lost to follow-up (up to 1302 days)|All randomized participants.|||Participants|||Count of Participants
2726637|NCT01047332|Secondary|Patient Survival|Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.|||days||Inter-Quartile Range|Median
2726638|NCT01047332|Primary|Time to Recurrent Biliary Obstruction|Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.|||days||Inter-Quartile Range|Median
2726639|NCT01047319|Secondary|Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study|"Shifts are presented as Baseline finding / Worse finding at anytime during the study.~Categories for findings are:~normal~abnormal, not clinically significant (Not CS)~abnormal, clinically significant (CS)"|Baseline (Day 0), Day 1 to 7.13 years|Safety analysis set of participants with both a baseline and a post-baseline ECG.|||Participants|||Count of Participants
2726640|NCT01047319|Secondary|Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study|"Counts include two conditions:~a change from High / Non-PCS at baseline to Low PCS at any point during the study~a change from Low / Non-PCS at baseline to High PCS at any point during the study~Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count."|Baseline (Day 0), Day 1 to 7.13 years|Safety analysis set of participants with both a baseline and a post-baseline value for the test.|||Participants|||Count of Participants
2726641|NCT01047319|Secondary|Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study|"Counts include two conditions:~a change from High / Non-PCS at baseline to Low PCS at any point during the study~a change from Low / Non-PCS at baseline to High PCS at any point during the study~Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count.~ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium"|Baseline (Day 0), Day 1 to 7.13 years|Safety analysis set of participants with both a baseline and a post-baseline value for the test.|||Participants|||Count of Participants
2726642|NCT01047319|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs|"Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:~Pulse rate: >=120 and increase >=30 beats/minute~Systolic blood pressure low: <=90 and decrease >=30 mmHg~Systolic blood pressure high: >=180 and increase >=30 mmHg~Diastolic blood pressure low: <=50 and decrease >=20 mmHg~Diastolic blood pressure high: >=100 and increase >=20 mmHg~Note that the change is compared to baseline,"|Baseline (Day 0 for extension), Day 1 up to 7.13 years|Safety analysis set of participants with a baseline and post-baseline value for that vital sign,|||Participants|||Count of Participants
2726650|NCT01047306|Post-Hoc|Change From Baseline in Liver Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Liver volume was obtained via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||milliliters||Standard Deviation|Mean
2726643|NCT01047319|Primary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.|Day 1 up to 7.13 years|Safety|||Participants|||Count of Participants
2726644|NCT01047306|Other Pre-specified|Change From Baseline in Phosphorylated Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF phosphorylated tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that phosphorylated tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||picograms/milliliter||Standard Deviation|Mean
2726645|NCT01047306|Other Pre-specified|Change From Baseline in Total Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that total tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||picograms/milliliter||Standard Deviation|Mean
2726646|NCT01047306|Secondary|Change From Baseline in The Total Sleep Disturbance (TSD) Score of The Children's Sleep Habits Questionnaire (CSHQ)|"The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. The questionnaire was designed for children aged 4 to 12 years. Parents were asked to think of a recent typical week of their child's sleep and to indicate how often sleep disturbance behaviors occurred. A 3-point scale was used for rating: usually if the sleep behavior occurs 5 to 7 times per week, sometimes for 2 to 4 times per week, and rarely for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance."|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||units on a scale||Standard Deviation|Mean
2726647|NCT01047306|Secondary|Change From Baseline in The Infant Toddler Quality of Life Questionnaire (ITQoL) Growth And Development Subscale|The ITQoL Questionnaire is a generic, validated health status measure for children aged 2 months up to 5 years, including items and scales to measure aspects of physical functioning, development, pain, mood, behavior, general health, and impact on parents. In this study the ITQoL was also administered to patients who were developmentally functioning at or below the age of years. Growth and development is one of 12 health concepts measured by ITQoL. Transformed scores for all subscales range from 0 to 100, with a higher score indicating better health. A positive value indicates improvement.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||units on a scale||Standard Deviation|Mean
2726648|NCT01047306|Secondary|"Number of Participants With Somewhat or Much Worse Change in Health as Assessed by The Child Health Questionnaire Parent Form 50 (CHQ-PF50)"|The parent form, CHQ-PF50, is designed to measure the physical and psychosocial well-being of children 5 years and older. In this trial it was used to assess the health of children 5 to 18 years of age. It consists of 13 health concepts including 11 multi-item and 2 single-item scales: physical function, role/social-emotional/behavioral, role/social-physical, bodily pain, general behavior, mental health, self-esteem, general health perceptions, change in health, parental impact-emotional, parental impact-time, family activities, and family cohesion. The parental impact scales capture the amount of emotional distress and time limitation experienced by the parent due to the child's physical health, emotional well-being, attention/learning abilities, ability to get along with others, and general behavior. The Change in Health section assesses changes in health over the previous year.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||participants|||Number
2726649|NCT01047306|Post-Hoc|Change From Baseline in Spleen Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Spleen volume was assessed via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||milliliters||Standard Deviation|Mean
2726755|NCT01045967|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2726651|NCT01047306|Post-Hoc|Change From Baseline in The Ratio of Mitral Valve Early Inflow Velocity (E) to Late Inflow Velocity (A)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Blood flow through the mitral valve is measured during one heartbeat.The E/A ratio measures the relationship between early (E) and late (A) inflow velocity by dividing E by A. A positive value indicates that either early flow through the mitral valve (E) increased or late flow through the valve (A) decreased.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||quotient of E/A||Standard Deviation|Mean
2726652|NCT01047306|Post-Hoc|Change From Baseline in Tricuspid Valve Regurgitant Velocity|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Backwards blood flow through the tricuspid valve is measured during one heartbeat. A negative value indicates decreased velocity.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||meters/second||Standard Deviation|Mean
2726653|NCT01047306|Post-Hoc|Percent of Participants With Trace Regurgitation as Assessed by ECG|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Regurgitation indicates that blood flows backwards through the valve.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726654|NCT01047306|Post-Hoc|Percent of Participants With Thickened Heart Valves as Assessed by Echocardiography (ECG)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726655|NCT01047306|Secondary|Percent of Participants With Profound Hearing Loss, as Assessed by the Auditory Brainstem Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Profound hearing loss: 91+ decibels hearing level (dBHL).|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||percentage of participants|||Number
2726656|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at End of Study, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
2726657|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 12 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
2726686|NCT01047241|Primary|Procedural Pain Intensity Score|Children <5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 5 years but < 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).|Pain assessment during painful medical procedure||||units on a scale||Inter-Quartile Range|Median
2726687|NCT01047189|Secondary|The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count||Baseline to 12 weeks|All patients were analyzed up to end of treatment or last visit.|||percentage of lesions||95% Confidence Interval|Mean
2726658|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 6 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
2726659|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at Baseline, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
2726660|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726661|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726662|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726688|NCT01047189|Primary|Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne|Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks|All patients were analyzed up to end of treatment or last visit.|||Percent of doses||Full Range|Median
2726701|NCT01046903|Other Pre-specified|Participant's Dosage Regimen|Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726663|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726664|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726665|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726666|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726667|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726689|NCT01047007|Secondary|MTD of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Solid Tumors|The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic solid tumors was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.|Cycle 1 (21 days)|Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study.||||||
2726668|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at End of Study|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726669|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 12 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726670|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 6 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726671|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at Baseline|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
2726672|NCT01047306|Secondary|Change From Baseline in The Total Disability Score (TDS) of The Four Point Scoring System (FPSS)|The FPSS is an MPS III-specific disability assessment that evaluates motor function, expressive language, and cognitive function on a 0- to 3- point scale and can be used for individuals of all ages. A score of 3 points is assigned for normal function, 2 points for beginning of regression, 1 point for severe level of regression, and 0 points for lost skills. The total disability score (TDS) is the average of the motor function, speech, and cognitive function scores (range: 0, 3). The scoring is based on the parent's response to a detailed questionnaire that covers several aspects of the disease. A positive value indicates improvement in function.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||units on a scale||Standard Deviation|Mean
2726673|NCT01047306|Secondary|Change From Baseline Values in Gray Matter Volume Assessed by Brain Magnetic Resonance Imaging (MRI)|"Total brain cortical gray matter volume was determined by analysis of brain MRI. The analysis was performed using Freesurfer software, which provides completely automated parcellation of the brain cortex and subcortical structures. In some cases, manual adjustments were necessary in cases of intensity normalization failure, resulting in erroneous white matter segmentation. A negative value indicates that gray matter volume decreased."|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||milliliters||Standard Deviation|Mean
2726674|NCT01047306|Other Pre-specified|Change From Baseline in Urine Glycosaminoglycan (GAG) Levels|Urine GAG was measured by a dye binding assay. A negative value indicates that GAG levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||mg GAG/mmol creatinine||Standard Deviation|Mean
2726756|NCT01045967|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2726675|NCT01047306|Primary|Change From Baseline in VABS-II Overall DQ Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||percentage of chronological age||Standard Deviation|Mean
2726676|NCT01047306|Primary|Change From Baseline in Vineland Adaptive Behavior Scales-II (VABS-II) Age-equivalent Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The mean age-equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||months||Standard Deviation|Mean
2726677|NCT01047306|Primary|Change From Baseline in BSID-III/KABC-II Developmental Quotient (DQ) Scores|The determination of whether a patient received BSID-III was based on an algorithm that includes the patient's calendar age and VABS-II age -equivalent score (See Outcome 1). The BSID-III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC-II is an individually administered measure of processing and reasoning abilities. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID-III DQ score is based on the cognitive domain. The DQ score for KABC-II is calculated from the average non-verbal age-equivalent score. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||percentage of chronological age||Standard Deviation|Mean
2726678|NCT01047306|Primary|Change From Baseline in Bayley Scales of Infant Development-III/Kaufman Assessment Battery for Children-II (BSID-III/KABC-II) Age-Equivalent Scores|Children 1 year-42 months were assessed by the BSID-III; those >42 months and with a developmental age of >42 months by the Vineland Adaptive Behavior Scales-II (VABS-II) were evaluated with the KABC-II. For children >42 months, but <42 months in developmental age, and those unable to complete at least 3 cognitive KABC-II subtests, the BSID-III was used. The BSID-III is a series of measurements to assess the motor, language, and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC-II is an individually administered measure of processing/reasoning abilities. Raw scores were converted to age- equivalent scores to measure ability, skill, and knowledge, expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound ). A positive value indicates improvement. The BSID-III and KABC-II age- equivalent scores were based on the cognitive domain and average non-verbal age-equivalent score, respectively.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||months||Standard Deviation|Mean
2726679|NCT01047293|Primary|Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part)|Number of patients who experienced a Dose Limiting Toxicity (DLT). DLT will be assessed in the first 28 days of dosing. Patients need to get dosed with 2 rounds/sessions of all chemotherapy agents in the first 28 days in order to be evaluable for DLT assessment. The primary endpoint is safety as summarized by dose limiting toxicity (DLT).|December 2011||||participants|||Number
2726680|NCT01047293|Primary|Progression Free Survival at Six Months||6 months|Progression free survival at six month was calculated using all patients receiving one dose of drug therapy at all of the different dosing levels. The six month progression free survival was determined using Kaplan Meier methods|||percentage of participants||95% Confidence Interval|Number
2726681|NCT01047241|Primary|Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine||Time=5-60 min after administration of investigational medicinal product||||minutes||Standard Deviation|Mean
2726682|NCT01047241|Primary|Bioavailability of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product||||percentage bioavailable||Standard Error|Mean
2726683|NCT01047241|Secondary|Acceptance of Intranasal Administration|Asking the children (parents for preverbal children) if they would like to receive this treatment again in a similar situation rather than analgesic suppositories, tablets, oral solutions, or injections?|Immediately after the procedure||||percentage of participants|||Number
2726684|NCT01047241|Secondary|Sedation Score (UMSS)|"University of Michigan Sedation Score (UMSS) (0-4, 0 awake and alert, 4 unarousable)"|Time= 0-70 min. after drug administration||||units on a scale||Full Range|Median
2726685|NCT01047241|Primary|Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product||||mcg/L||Standard Deviation|Mean
2726690|NCT01047007|Primary|Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer|The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic esophageal, head and neck, or gastric cancer was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.|Cycle 1 (21 days)|Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study.||||||
2726691|NCT01047007|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2.|Cycle 1 (21 days)|The DLT-evaluable population consisted of participants who received at least one dose of MK-1775 and completed Cycle 1 of Parts 1, 2A1, 2A2, or discontinued due to toxicity.|||Participants|||Number
2726692|NCT01046903|Other Pre-specified|Number of Participants With Hematoma|Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726693|NCT01046903|Other Pre-specified|Number of Participants Compliant With the Treatment|Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.|Baseline up to Week 5|Data was collected but not statistically summarized for analysis.|||Participants|||Number
2726694|NCT01046903|Other Pre-specified|Administration Schedule of Treatment|Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726695|NCT01046903|Primary|Physician's Assessment of Efficacy of Treatment|Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Full Analysis Set (FAS) included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726696|NCT01046903|Other Pre-specified|Physician's Assessment of Tolerability of Treatment|Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726697|NCT01046903|Other Pre-specified|Participant's Global Evaluation of Treatment|Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726698|NCT01046903|Other Pre-specified|Number of Participants With Bleeding|Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor bleeding was defined as bleeding that did not meet the definition of major bleeding.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726699|NCT01046903|Other Pre-specified|Number of Participants With Thromboembolism|Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin).|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726700|NCT01046903|Other Pre-specified|Number of Participants With Risk Factors|Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA.|Baseline|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
2726702|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|12 months post procedure|One subject was lost to follow-up following the procedure. 2 subjects were lost to follow-up after the 30 day visit. 2 subjects were lost to follow-up after the 3 month visit. 3 subjects were lost to follow-up following the 6 month visit. 4 subjects were lost to follow-up after the 9 month visit and 2 subjects missed the 12 month visit.|||percentage of ears|Participants|95% Confidence Interval|Number
2726703|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|9 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two subjects were lost to follow-up after the 3 month visit. Three additional subjects were lost to follow-up following the 6 month visit and one subject missed the 9 month visit.|||percentage of ears|Participants|95% Confidence Interval|Number
2726704|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|6 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two additional subjects were lost to follow-up after the 3 month visit and two subject missed the 3 month visit.|||percentage of ears|Participants|95% Confidence Interval|Number
2726705|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|3 months|One subject was lost to follow-up immediately following the procedure. Two additional subjects were lost to follow-up after the 30 day visit and one subject missed the 30 day visit.|||percentage of ears|Participants|95% Confidence Interval|Number
2726706|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|30 days|One subject was lost to follow-up immediately following the procedure.|||percentage of ears|Participants|95% Confidence Interval|Number
2726707|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|9 Months|3 subjects lost to follow-up after 6 mo visit. 1 subject missed 9 mo visit. 2 subjects lost to follow-up after 3 mo visit. 2 subjects lost to follow-up after 30 day visit. 1 subject lost to follow-up following procedure. Thus, only 3 ears (= 3 participants) of 16 participants returning at 9 mos had unextruded tubes for assessment of patency.|||percentage of tubes|Participants|95% Confidence Interval|Number
2726708|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|6 months|Two subjects lost to follow-up after 3 month visit. Two subjects missed 6 month visit. Two subjects lost to follow-up after 30 day visit. One subject lost to follow-up immediately following procedure. Thus, only 13 ears (= 9 participants) of 18 participants returning at 6 months had unextruded tubes for assessment of patency.|||percentage of tubes|Participants|95% Confidence Interval|Number
2726709|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|3 months|Two subjects were lost to follow-up after the 30 day visit and one subject missed the 3 month visit. One subject was lost to follow-up immediately following the procedure. Thus, only 28 ears of 21 participants had unextruded tubes for assessment of tube patency.|||percentage of tubes|Participants|95% Confidence Interval|Number
2726710|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|30 days|One subject (one ear) was lost to follow-up immediately following the procedure.|||percentage of tubes|Participants|95% Confidence Interval|Number
2726711|NCT01046877|Secondary|Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure||12 months|Over the course of 12 months, a total of 17 subjects (25 ears) were assessed at varying follow-up time points as having had tubes extruded. Ears analyzed included those for which a tube was observed to extrude at any follow-up visit and ears that completed the 12 month visit.|||percentage of tubes|Participants|95% Confidence Interval|Number
2726712|NCT01046877|Primary|Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.|TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.|Procedural|One subject was missing data on intraprocedural adverse events and is excluded from this analysis.|||percentage of ears|Participants|95% Confidence Interval|Number
2726713|NCT01046695|Primary|Mean Pain Score|Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.|hour 1 to hour 48 after awakening from video-assisted thoracic surgery||||units on a scale||Standard Deviation|Mean
2726714|NCT01046695|Secondary|Satisfaction With Pain Control at 48 Hours|Pain control was measured by using a Visual Analog Scale (VAS) with a range from 0-10; with 0 being very satisfied and 10 being very dissatisfied.|48 hours after awakening from video-assisted thoracic surgery|11 participants on each arm did not complete the VAS.|||participants|||Number
2726715|NCT01046695|Secondary|Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours|As subjects could have been prescribed many different analgesics, the amount of pain medication was converted to the standard oral morphine equivalents (OME), so that the mean dose needed could be compared.|24 hours and 48 hours after awakening from video-assisted thoracic surgery||||mg of oral morphine||Standard Deviation|Mean
2726716|NCT01046682|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks|Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.|Entry and week 13 visits|Number of participants for analysis was determined by the number of participants that had 2 FMD tests performed|||% change from baseline||Inter-Quartile Range|Median
2726717|NCT01046669|Primary|Mortality|Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone|28 days|All subjects randomized|||Participants|||Count of Participants
2726729|NCT01046136|Primary|Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.|Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.|Baseline and Day 4||||units on a scale||Standard Deviation|Mean
2726718|NCT01046643|Secondary|Neuropsychological Testing Scores - Visual Learning Retention|"Changes in neuropsychological testing measures (visual learning retention) with hormone use (either estradiol or progesterone) versus placebo.~Subjects are given tests that present them with a series of pictures. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the California Verbal Learning Test - 2nd edition.~The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.|||percent retention||Standard Deviation|Mean
2726719|NCT01046643|Primary|Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in visual tasks with hormone use (either estradiol or progesterone) versus placebo.~The test is a visual working memory task, where the women are presented with 3 geometric grids on the screen. The target grid is on top, and 2 test grids are on the bottom. The women must decide if the right or left test grid matches the grid on top. There are 3 conditions: a match condition where all 3 grids are shown simultaneously, and 2 delay conditions, where the target grid is shown first, disappears, and the test grids appear after a 1 or a 4 second delay.~The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.|||percent BOLD signal changes||Standard Deviation|Mean
2726720|NCT01046643|Secondary|Neuropsychological Testing Scores - Verbal Learning Retention|"Changes in neuropsychological testing measures (verbal learning retention) with hormone use (either estradiol or progesterone) versus placebo.~Subjects are given tests that present them with a series of words. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the Benton Visual Memory Test, Revised.~The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.|||percent retention||Standard Deviation|Mean
2726721|NCT01046643|Primary|Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in verbal tasks with hormone use (either estradiol or progesterone) versus placebo.~The test is a deep and shallow verbal processing task, where the subjects are presented lists of words, one word at a time, and are asked to make one of 2 decisions about each list. One decision is whether each word is written in upper or lower case letters (shallow processing), and the other decision is whether each word denotes an abstract or concrete concept (deep processing).~The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged and unable to be used in the analysis.|||percent BOLD signal changes||Standard Deviation|Mean
2726722|NCT01046565|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)|||participants|||Number
2726723|NCT01046565|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol|||participants|||Number
2726724|NCT01046396|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire at Week 3|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)|||participants|||Number
2726725|NCT01046396|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol|||participants|||Number
2726726|NCT01046253|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
2726727|NCT01046253|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
2726728|NCT01046253|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng/mL||Standard Deviation|Mean
2726731|NCT01046136|Primary|Investigator's End of Study Assessment of Treatment|Yes the investigator would use this treatment for cold symptoms in the future.|7 days|MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.|||participants|||Number
2726732|NCT01046110|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One site was closed, hence 11 randomised subjects (4 in IDeg and 7 in DPP-IV group/arm) were excluded from the FAS. Fasting plasma glucose values were missing for another 8 subjects, hence did not contribute to the analysis.|||mmol/L||Standard Deviation|Mean
2726733|NCT01046110|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2726734|NCT01046084|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
2726735|NCT01046084|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
2726736|NCT01046084|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng/mL||Standard Deviation|Mean
2726737|NCT01045993|Secondary|Number of Participants Per Categorical Score for Global Assessment of Study Treatment|At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.|||participants|||Number
2726738|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726739|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726740|NCT01045993|Secondary|Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension|Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726741|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||degrees||Standard Deviation|Mean
2726742|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||degrees||Standard Deviation|Mean
2726743|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||degrees||Standard Deviation|Mean
2726744|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726745|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726746|NCT01045993|Secondary|Change From Baseline (Bsl) in Combined Flexibility Score: Extension|Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726747|NCT01045993|Secondary|Change From Baseline in Individual Time-point Back Stiffness Scores|Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness).|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.|||scores on a scale||Standard Deviation|Mean
2726748|NCT01045993|Secondary|Individual Time-Point Pain Relief Scores|Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.|||scores on a scale||Standard Deviation|Mean
2726749|NCT01045993|Secondary|Time to Treatment Failure|Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study).|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population. Time to treatment failure not calculable as there were no treatment failures in this study. No participants required use of rescue medication or discontinued study prior to 8 hour evaluation.||||||
2726750|NCT01045993|Secondary|Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours|Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726751|NCT01045993|Secondary|Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)|TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
2726752|NCT01045993|Primary|Time to First Perceptible Relief (Confirmed by Meaningful Relief)|"First perceptible relief defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled first perceptible relief (any pain relieving effect), provided the participant also depressed the second stopwatch labeled meaningful relief (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee."|Baseline (time of wrap application or oral treatment administration) up to 4 hours|Intent-to-treat population (ITT): all randomized participants who applied/dosed with study product and had a baseline assessment. Median and/or upper limit of CI reported as 240 minutes if >240 minutes. No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.|||minutes||95% Confidence Interval|Median
2726753|NCT01045993|Secondary|Time to Meaningful Relief|"Time to meaningful relief defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating meaningful relief (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee."|Baseline (time of wrap application or oral treatment administration) up to 4 hours|ITT population. Median and/or upper limit of CI reported as 240 minutes if median or upper limit >240 minutes.|||minutes||95% Confidence Interval|Median
2726757|NCT01045798|Primary|The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study.|"The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol.~Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug."|1 to 14 days|Of the 114 participants anticipated to enroll in this study, 15 actually enrolled and only 14 received study drug. The participant who did not receive study drug was discontinued; the remaining 14 received at least one dose of study drug, met inclusion/exclusion criteria, and therefore qualified for the full analysis set used for summary analyses.|||Participants|||Number
2726758|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2726759|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2726760|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2726761|NCT01045707|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed. For 24 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2726762|NCT01045707|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2726763|NCT01045707|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2726764|NCT01045694|Secondary|Strength||twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.||||||
2726765|NCT01045694|Secondary|Range of Motion||twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.||||||
2726766|NCT01045694|Primary|Pain||twenty-four hours, ten days, twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.||||||
2726767|NCT01045551|Secondary|Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)||Week 12, Week 16||||telangiectasia count||Standard Error|Mean
2726768|NCT01045551|Secondary|Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)|physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)|Baseline, Week 12||||telangiectasia count||Standard Error|Mean
2726769|NCT01045551|Secondary|Change From Baseline in Erythema Rating Visit 8 (Week 12)|The change in the Physician Overall Erythema Severity. Scale range 0 - 3. 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe. 0 is considered a better outcome, 3 is considered a worse outcome.|Baseline, Week 12||||units on a scale||Standard Deviation|Mean
2726770|NCT01045551|Secondary|Change in Physician 7 Point Global Assessment From Baseline to Week 12|The Physician Global 7-point Assessment. Scale range: 0-7. 0 = clear, 1 = minimal, 2 = mild, 3 = mild to moderate, 4= moderate, 5= moderate to severe, 6 = severe. 0 is a better outcome, 6 is a worse outcome. No subscales were used.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
2726771|NCT01045551|Primary|Change From Baseline in the Total Number of Papulopustular Lesions at Week 12|Papule and pustule count consisted of direct measurement of the number of papules/pustules on the face. Papule and pustule count, compared between baseline and end of treatment Week 12 was calculated|Baseline to Week 12||||papule count||Standard Deviation|Mean
2726772|NCT01045499|Secondary|Percentage of Excess BMI Change|Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).|Baseline and up to 5 years from start of study.|Includes individuals with confirmed band status at 5 years after surgery.|||percent change||Standard Deviation|Mean
2726773|NCT01045499|Primary|Percentage of Excess Weight Change (EWL)|Weight change evaluated in terms of % excess weight loss (EWL).|Baseline and up to 5 years from start of study.|Includes individuals with confirmed band status at 5 years after surgery.|||percent change||Standard Deviation|Mean
2726774|NCT01045460|Secondary|Effect of aMILs on Clonogenic Myeloma Precursors|• Examine side population of CD19 enriched PBLs throughout study.|Days 60, 180, and 360||2020-10-31|10/2020||||
2726775|NCT01045460|Secondary|The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)|Osteocalcin|Days 60, 180, 360||2020-10-31|10/2020||||
2726776|NCT01045460|Secondary|The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)|bAlkaline phosphatase|Days 60, 180, 360||2020-10-31|10/2020||||
2726777|NCT01045460|Secondary|The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)|Serum C Telopeptide|Days 60, 180, 360||2020-10-31|10/2020||||
2726778|NCT01045460|Secondary|The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)||Days 60, 180, and 360||2020-10-31|10/2020||||
2726779|NCT01045460|Secondary|Anti-tumor Immune Response|"Evaluate tumor specific responses in blood and bone marrow~Examine T cell responses to DC-pulsed myeloma cell lines~Examine induction of novel antibody responses"|Days 60, 180, and 360||2020-09-30|09/2020||||
2726780|NCT01045460|Secondary|Safety as Measured by Grade 3-5 Adverse Events|Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to MILs or the myeloma vaccine.|Up to 1 year||||Participants|||Count of Participants
2726781|NCT01045460|Secondary|Feasibility as Measured by Participant Withdrawal or Removal|Number of participants who withdrew or were removed from the study for reasons other than lack of efficacy prior to completion.|Up to 1 year||||Participants|||Count of Participants
2726782|NCT01045460|Secondary|Evaluate Progression-free Survival and Overall Survival|Median number of months that participants were alive (overall survival) and alive without disease relapse or progression (progression-free survival).|Up to 5 years|||||||
2726783|NCT01045460|Primary|Response Rates by Blade Criteria|"Number of participants with each disease response category utilizing the Blade criteria:~Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.~Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with < 5% plasma cells.~Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein < 100 mg/24 hours.~Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein.~Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein.~Stable Disease (SD): Defined as not falling into any other response category.~Overall response rate (ORR): Total of CR, nCR, VGPR, and PR."|Up to 1 year|Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome.|||Participants|||Count of Participants
2726784|NCT01045447|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS. For 23 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2726785|NCT01045447|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2726786|NCT01045421|Secondary|Phase 2: Relationship Between Clinical Response and Molecular Markers of Response|In SCLC,chemo-sensitive/resistant population were analyzed;in breast cancers,ER2 and ER2 status were analyzed.HR+ =estrogen receptor-positive or progesterone receptor-positive. HER+ =human epidermal growth factor receptor 2 (HER2). Triple negative =negative for estrogen receptors, progesterone receptors, and HER2.Clinical response according to RECIST version 1.1. CR:complete disappearance of all target lesions,non-target disease,except nodal disease;all nodes decrease to normal (short axis <10 mm);no new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions (SLD);short axis was used in the sum for target nodes,longest diameter used in the sum for all other target lesions;no unequivocal progression of non-target disease;no new lesions. Progressive Disease (PD): >=20% rise in SLD from the smallest value on study;unequivocal progression of existing non-target lesions. Stable Disease (SD):Neither sufficient shrinkage for PR nor sufficient increase for PD.|12 months|Response-Evaluable population. Data is reported only for SCLC and breast cancer cohorts becuase these cohorts showed clinical meaningful single agent activity, thus subgroup analysis were done to assess whether a particular subgroup of participants was more or less responsive to alisertib. Rest of the cohorts did not show meaningful activity.|||percentage of participants||95% Confidence Interval|Number
2726787|NCT01045421|Secondary|Phase 1: Steady State Oral Clearance (CLss/F) for Alisertib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-tau), expressed in liter per hour (L/hr).|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2726788|NCT01045421|Secondary|Phase 1: Peak to Trough Ratio for Alisertib|Peak to trough ratio was estimated as a ratio of Cmax at Day 7 and the minimum observed plasma concentration (Ctrough) of alisertib at Day 7. Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Ctrough is the minimum plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||ratio||Standard Deviation|Mean
2726789|NCT01045421|Secondary|Phase 1: Rac- Accumulation Ratio for Alisertib|Rac was estimated as a ratio of AUC (0-tau) at Day 7 and AUC (0-tau) at Day 1. Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||ratio||Standard Deviation|Mean
2726790|NCT01045421|Secondary|Phase 1: Terminal Phase Elimination Half-life (T1/2) for Alisertib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.|||hours||Standard Deviation|Mean
2726791|NCT01045421|Secondary|Phase 1: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||nanomole*hour (nM*hr)||Geometric Coefficient of Variation|Geometric Mean
2726792|NCT01045421|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 1 and Day 7 assessment were available.|||hours||Full Range|Median
2726793|NCT01045421|Secondary|Phase 1: Cmax- Maximum Observed Plasma Concentration for Alisertib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours post-dose|Pharmacokinetic (PK)-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
2726794|NCT01045421|Secondary|Phase 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after the last dose of study drug|Safety population included all participants who received any amount of alisertib.|||participants|||Number
2726795|NCT01045421|Secondary|Phase 2: Duration of Response (DOR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response=(the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). CR: complete disappearance of all target lesions and non-target disease, except nodal disease; all nodes decreased to normal; no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. Tumor progression: >=20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); absolute increase of >=5 mm; appearance of >=1 new lesions is also considered progression. DOR calculated for the subgroup of participants with objective response.|Baseline up to Week 50|Included a subset of response-evaluable population who had objective tumor response.|||days||95% Confidence Interval|Median
2726796|NCT01045421|Secondary|Phase 2: Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until disease progression, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.|||days||95% Confidence Interval|Median
2726811|NCT01045135|Secondary|Change in Bladder Neck Mobility Measured Via 3D Ultrasound|3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Bladder neck mobility was measured at gestational week 21 and 37, at rest and during Valsalva maneuver . The change in mobility from rest to valsalva was computed between the two different timepoints.|gestational week 21 and 37||||cm||Standard Deviation|Mean
2726797|NCT01045421|Secondary|Phase 2: Progression-free Survival (PFS)|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until progressive disease, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.|||days||95% Confidence Interval|Median
2726798|NCT01045421|Primary|Phase 2: Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until complete response or partial response, assessed every 2 cycles up to end of study (up to 50 cycles)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2726799|NCT01045421|Primary|Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)|Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay in initiation of the subsequent therapy cycle by >7 days due to treatment-related toxicity; >=Grade 3 nonhematological toxicity except >=Grade 3 nausea/emesis occurred in the absence of optimal antiemetic therapy; >=Grade 3 diarrhea occurred in the absence of optimal supportive therapy with loperamide/comparable antidiarrheal; Grade 3 fatigue for <1 week; Other Grade 3 nonhematological toxicity that could be safely, reliably controlled to <=Grade 2 with appropriate treatment.|Phase 1: Cycle 1 Day 1 to Cycle 2 Day 21|DLT-Evaluable population: all participants in the Phase 1 portion of the study who either experienced DLT during Cycle 1 or completed at least 85% of the planned doses of alisertib and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.|||participants|||Number
2726800|NCT01045265|Secondary|Semen to Plasma Distribution of Raltegravir|Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.|6 months||||ratio||Inter-Quartile Range|Median
2726801|NCT01045265|Secondary|Seminal Distribution of Raltegravir|Determine the area under the concentration time curve of raltegravir in semen.|6 months||||h mg/l||Inter-Quartile Range|Median
2726802|NCT01045265|Secondary|Semen to Plasma Raltegravir Concentrations|Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.|6 months||||ratio||Inter-Quartile Range|Median
2726803|NCT01045265|Primary|Seminal Concentrations of Raltegravir.|Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.|6 months||||mg/l||Inter-Quartile Range|Median
2726804|NCT01045187|Secondary|Assess Occurence Rate of Toxicities||through 3 month follow up post treatment|||||||
2726805|NCT01045187|Secondary|Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice||through 3 month post treatment|||||||
2726806|NCT01045187|Primary|Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System||through completion of radiation therapy||||Participants|||Number
2726807|NCT01045161|Secondary|Part B: Peak FEV1|Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.|||L||Standard Error|Least Squares Mean
2726808|NCT01045161|Primary|Part B: Morning Predose (Trough) FEV1|Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.|||L||Standard Deviation|Mean
2726809|NCT01045161|Secondary|Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.|||L||Standard Error|Least Squares Mean
2726810|NCT01045161|Primary|Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.|||L||Standard Error|Least Squares Mean
2726812|NCT01045135|Primary|Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound|3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.|gestational week 21 and 37||||cm||Standard Deviation|Mean
2726813|NCT01045135|Other Pre-specified|Health Related Complaints||20 months|||||||
2726814|NCT01045135|Primary|Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37|3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.|21 weeks and 37 weeks of gestation||||cm||Standard Deviation|Mean
2726815|NCT01045135|Primary|Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.|3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes|21 weeks and 37 weeks of gestation||||cm||Standard Deviation|Mean
2726816|NCT01045122|Primary|Respiratory Disturbance Index|respiratory events (apneas, hypopneas) per hour|during infusion of study drugs|Per protocol|||events per hour||Standard Deviation|Mean
2726817|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL||Standard Deviation|Mean
2726818|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL||Standard Deviation|Mean
2726819|NCT01045096|Primary|The Peak Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng/mL||Standard Deviation|Mean
2726820|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL/mg||Standard Deviation|Mean
2726821|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL/mg||Standard Deviation|Mean
2726822|NCT01045096|Other Pre-specified|Dose-normalized Peak Plasma Concentration (Cmax/Dose)|Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng/mL/mg||Standard Deviation|Mean
2726823|NCT01045096|Primary|Time to Reach the Peak Plasma Concentration (Tmax)|Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||hours||Standard Deviation|Mean
2726824|NCT01045057|Secondary|Postoperative Results|Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.|1 month|Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.|||Number of patients|||Number
2726825|NCT01045057|Secondary|Cost Effectiveness Calculation|"cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set.~Measurements are: time needed to perform procedure"|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.|||seconds||Standard Deviation|Mean
2726826|NCT01045057|Secondary|Satisfaction of Physician|Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.|||Number of times new set was preferred|||Number
2726827|NCT01045057|Primary|Success Rate of Procedure|As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.|immediate observation during surgery|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.|||Nr part. with succesful insertions|||Number
2726828|NCT01045031|Secondary|Insulin-like Growth Factor (IGF-1)||Baseline and 5 years||||ng/mL||Standard Deviation|Mean
2726829|NCT01045031|Secondary|Self Rating by Questionnaires|The following self rating scales were used: WHO-5 Quality of Life Assessment (Braeher, E., Muehlan, H., Albani, C., & Schmidt, S. (2007). Testing and standardization of the German version of the EUROHIS-QOL and WHO-5 quality-of life-indices. Diagnostica, 53(2), 83-96.). Range: 0 - 25, higher scores indicate better quality of life.|Baseline and 5 years|Study population (Baseline and follow-up)|||point scale||Standard Deviation|Mean
2726830|NCT01045031|Primary|Brain-derived Neurotrophic Factor (BDNF)||Baseline and 5 years|Baseline values differ from published data, since BDNF-levels had to be re-assessed from banked material due to a manufacturer-based change of the analysis kit.|||ng/mL||Standard Deviation|Mean
2726831|NCT01045031|Primary|the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment|Hypothesis will be tested at the second follow-up examinations.|10 years||2019-12-31|12/2019||||
2726832|NCT01044966|Secondary|Quality of Life Outcomes Measurement|"Participants recorded are those who had an improvement in QOL score, QOL outcomes will be assessed and recorded using the EORTC QLQ C30 version 3.~This 30 question questionnaire will be used to asses our patient overall feeling of well-being during the trial. Questions to assess quality of life are measured from 1-4 with the following graded values:~Not at all~A little~Quite a bit~Very much Lower total scores are consistent with better quality of life and changes of greater or equal to 10 points are considered a significant change in quality of life."|52 weeks||||Participants|||Count of Participants
2726833|NCT01044966|Secondary|Response Rate of Drug Treatment|Those responding to study drug will be recorded. Response will be defined as stable neurological examination in conjunction with the absence of progression as defined above.|52 weeks||||Participants|||Count of Participants
2726834|NCT01044966|Secondary|Progression Free Survival|The progression free survival of patients receiving study drug will be recorded. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|At 6 months||||Participants|||Count of Participants
2726835|NCT01044966|Secondary|Proportion of Patients With Recurrent GBM Treated With ITV DepoCyt in Combination With Oral Temozolomide Who Are Progression-free at 16 Weeks.|Eligibility of patients with GBM that are able to receive study drug to estimate the proportion of patients with recurrent GBM treated with ITV DepoCyt in combination with oral temozolomide who are progression-free at 16 weeks. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|16 weeks||||Participants|||Count of Participants
2726836|NCT01044966|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|The type and number of adverse events will be recorded and reported by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0|52 weeks||||Participants|||Count of Participants
2726837|NCT01044862|Secondary|Live Birth Rate||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||participants|||Number
2726838|NCT01044862|Secondary|Time to Pregnancy||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||days||Standard Deviation|Mean
2726839|NCT01044862|Secondary|Rate of Pregnancy Obtained||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||participants|||Number
2726840|NCT01044862|Primary|Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||number of multiples|||Number
2726841|NCT01044771|Secondary|Patients Without HIV Re-bound|HIV Viral load blood test at week 24|24 weeks|Subjects entered with undetectable Viral Load and Proteinuria|||participants|||Number
2726842|NCT01044771|Primary|Patients With Reduced or Resolved Proteinuria|Measurement of Protein in Urine samples at end of study visit|24 weeks||||participants|||Number
2726843|NCT01044758|Secondary|Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task|Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance.|2 weeks||||percent correct recalled||Standard Error|Mean
2726844|NCT01044758|Primary|Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI|Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.|2 weeks||||mean beta coefficient||Standard Error|Mean
2726845|NCT01044745|Secondary|Transplant-related Mortality (TRM)|Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.|At day 100||||Participants|||Count of Participants
2726846|NCT01044745|Secondary|Overall Survival|Estimated using Kaplan-Meier estimator.|From the date of transplant with death from any cause as a censored event, up to 2 years||||months||Full Range|Median
2726849|NCT01044732|Secondary|Times for Withdrawal Phase and for Complete Procedure|For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|All subjects in study (i.e., Group A and Group B combined)|||Minutes||Standard Deviation|Mean
2726850|NCT01044732|Primary|Detection Rates for Adenomas and for Total Polyps|Numbers of polyps and adenomas detected in first and second procedures for each group|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|Per-protocol population|||Polyps or adenomas detected|||Number
2726851|NCT01044706|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|maximum observed concentration of drug substance in plasma|144 hour||||ng/mL||Standard Deviation|Geometric Mean
2726852|NCT01044706|Primary|AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)|AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)|144 hour|per protocol|||ng*h/mL||Standard Deviation|Geometric Mean
2726853|NCT01044693|Secondary|Change in Heart Rate During the Night|Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect|8 pm - 8 am|Participants who completed the 4 treatment arms|||bpm||Standard Error|Mean
2726854|NCT01044693|Secondary|Orthostatic Tolerance the Following Morning|Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test|10 min standing|Comparisons were made only for patients who could stand after all treatment groups|||mm Hg*min||Standard Error|Mean
2726855|NCT01044693|Secondary|Nocturnal Urinary Sodium Excretion|Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.|8 pm - 8 am|Participants with complete urine collections during the 4 study nights|||mEq/mg||Standard Error|Mean
2726856|NCT01044693|Primary|Change in Systolic Blood Pressure During the Night|Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention|8 pm - 8 am|Participants who completed the 4 treatment arms|||mm Hg||Standard Error|Mean
2726857|NCT01044589|Secondary|Number of Participants Reporting a Decrease in Incontinence Episodes Per Week||24 months||||Participants|||Count of Participants
2726858|NCT01044589|Primary|Number of Participants Reporting a Decrease in Incontinence Episodes Per Week||12 months||||Participants|||Count of Participants
2726859|NCT01044537|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2726860|NCT01044537|Secondary|Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit*deciliter*hour [mU*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*liter*hour [mg*liter*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. ‘N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm group, respectively.|||(mU*dL*hour)/(mg*liter*hour)||Standard Deviation|Mean
2726861|NCT01044537|Secondary|Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)|Ratio of C-peptide Delta C30 (in terms of nanogram*deciliter [ng*dL]) to glucose delta C30 (in terms of milligram*milliliter [mg*mL]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||(ng*dL)/(mg*mL)||Standard Deviation|Mean
2726862|NCT01044537|Secondary|Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of insulin delta C30 (in terms of milliunits*deciliter [mU*dL]) to glucose delta C30 (in terms of milligram*liter [mg*liter]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||(mU*dL)/(mg*Liter)||Standard Deviation|Mean
2726863|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2726875|NCT01044498|Secondary|Serum Soluble Interleukin-6 Receptor (sIL-6R) Level|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. Serum levels of soluble interleukin-6 receptor were analyzed using a validated ELISA.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||ng/mL||Standard Deviation|Mean
2726864|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2726865|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2726866|NCT01044537|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Standard Deviation|Mean
2726867|NCT01044537|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2726868|NCT01044537|Primary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2726869|NCT01044537|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2726870|NCT01044537|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2726871|NCT01044537|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2726872|NCT01044537|Secondary|Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram*deciliter*hour [ng*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*milliliter*hour [mg*mL*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hours pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hours post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm group, respectively.|||(ng*dL*hour)/(mg*mL*hour)||Standard Deviation|Mean
2726873|NCT01044537|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to 10 days after last dose of study medication (up to 11 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2726874|NCT01044498|Secondary|Serum C-reactive Protein (CRP) Level|Blood samples were collected pre-dose of tocilizumab infusion on Day 1 of Cycle 2 and on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and on Days 1, 7, and 21 of Cycle 3. Serum levels of C-reactive protein were measured by the Tina-quant CRP (latex) high-sensitivity Roche Immunoturbidimetric method.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||mg/L||Standard Deviation|Mean
2726876|NCT01044498|Secondary|Apparent Volume of Distribution (Vz) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The apparent volume of distribution (Vz), computed as CL/Kel where CL is clearance and Kel is the apparent elimination rate, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||L||Standard Deviation|Mean
2726877|NCT01044498|Secondary|Clearance (CL) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. Clearance (CL), computed as dose/AUCinf, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||mL/hr||Standard Deviation|Mean
2726878|NCT01044498|Secondary|Terminal Half-life (t½) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The terminal half-life (t½) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
2726879|NCT01044498|Secondary|Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The area under the serum concentration-time curve from 0 to infinity (AUCinf) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above). AUCinf was computed using the linear trapezoidal rule to tlast plus Clast/Kel, where tlast is the time of the last measurable concentration, Clast is the last measurable concentration, and Kel is the apparent elimination rate, computed as the magnitude of the slope from the log-linear regression of the apparent terminal elimination phase of the serum concentration-versus-time curve.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||µg•hr/mL||Standard Deviation|Mean
2726880|NCT01044498|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The time to reach maximum serum concentration was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
2726881|NCT01044498|Secondary|Maximum Observed Serum Concentration (Cmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated enzyme-linked immunosorbent assay (ELISA). The maximum observed plasma concentration (Cmax) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||µg/mL||Standard Deviation|Mean
2726882|NCT01044498|Secondary|Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The apparent oral clearance (CL/F) was derived from the plasma concentrations using a non-compartmental method and computed as dose/AUC0-24 with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||mL/hr||Standard Deviation|Mean
2726883|NCT01044498|Secondary|Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The terminal half-life (t½) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
2726899|NCT01044290|Secondary|FACIT-SP|The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.|Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)||||units on a scale||Standard Deviation|Mean
2726884|NCT01044498|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||pg•hr/mL||Standard Deviation|Mean
2726885|NCT01044498|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The time to reach the maximum plasma concentration (Tmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
2726886|NCT01044498|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The maximum observed plasma concentration (Cmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.|||pg/mL||Standard Deviation|Mean
2726887|NCT01044498|Primary|Serum Progesterone Level|Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.|Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.|||ng/mL||Standard Deviation|Mean
2726888|NCT01044459|Secondary|Change From Baseline in Peak FEV1|Change From Baseline in Peak FEV1 in liters at Week 52.|52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.|||L||Standard Error|Least Squares Mean
2726889|NCT01044459|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.|From baseline to 52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.|||L||Standard Error|Least Squares Mean
2726890|NCT01044433|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0|5 years||||Participants|||Count of Participants
2726891|NCT01044433|Secondary|Progression-free Survival||5 years||||months||90% Confidence Interval|Number
2726892|NCT01044433|Secondary|Disease Control Rate||5 years||||percentage||90% Confidence Interval|Number
2726893|NCT01044433|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|5 years||||percentage||90% Confidence Interval|Number
2726894|NCT01044433|Primary|Overall Survival||5 years||||Months||90% Confidence Interval|Mean
2726895|NCT01044303|Secondary|To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.||24 months||||participants|||Number
2726896|NCT01044303|Primary|Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)||24 months|This was a pilot study to examine the effect of MPA escalation on DSA reduction.|||percent of MFI change||Standard Deviation|Mean
2726897|NCT01044290|Secondary|FACT-G - Social Sub-scale|"Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating not at all and 4 indicating, very much in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being."|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)||||units on a scale||Standard Deviation|Mean
2726898|NCT01044290|Primary|QUAL-E Life Completion Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)||||units on a scale||Standard Deviation|Mean
2726900|NCT01044290|Secondary|CES-D|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)||||units on a scale||Standard Deviation|Mean
2726901|NCT01044290|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)||||units on a scale||Standard Deviation|Mean
2726902|NCT01044290|Primary|QUAL-E - Preparation Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)||||units on a scale||Standard Deviation|Mean
2726903|NCT01044264|Primary|Reduction of Inflammatory Lesions|The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).|Baseline and week 11|per-protocol population|||percentage reduction of lesions|||Number
2726904|NCT01044212|Secondary|Consistency of First Postoperative Bowel Movement|"The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.~The seven types of stool are:~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid"|Within 1 week of surgery||||Bristol Stool Scale||Standard Deviation|Mean
2726905|NCT01044212|Secondary|Pain Level Associated With First Postoperative Bowel Movement|The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.|Within 1 week of surgery||||VAS pain score||Standard Deviation|Mean
2726906|NCT01044212|Primary|Time to First Post-op Bowel Movement|The time to first post-operative bowel movement was measured in hours after surgery.|Within 1 week of surgery|Power analysis|||hours||Standard Deviation|Mean
2726907|NCT01044056|Primary|AUC 0-infinity (PK Parameter) for the ASPE Group.|AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.|21 days of active treatment and the washout period thereafter||||ng.h/mL||Standard Deviation|Mean
2726908|NCT01044056|Primary|AUC 0-tlast (PK Parameter) for the ASPE Group.|AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication.|||ng.h/mL||Standard Deviation|Mean
2726909|NCT01044056|Primary|Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group|AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment|21 days|Subjects who received at least one dose of medication.|||nh.h/mL||Standard Deviation|Mean
2726910|NCT01044056|Primary|Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group|Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication|||pg/ml||Standard Deviation|Mean
2726911|NCT01044030|Secondary|Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.|Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment|12 weeks||||Participants|||Count of Participants
2726912|NCT01044030|Secondary|Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.|Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment|12 weeks||||Participants|||Count of Participants
2726913|NCT01044030|Secondary|Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae|Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites|12 weeks|This outcome measure is limited to those subjects enrolled in the local enrolling sites only.|||percentage of participants|||Number
2726914|NCT01044030|Secondary|Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media|Proportion of subjects with no antibiotic use during the study period|12 weeks||||percentage of participants|||Number
2726915|NCT01044030|Primary|Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media|Proportion of subjects who remained free of acute otitis media throughout the study period|12 weeks||||percentage of particpants|||Number
2726916|NCT01043939|Secondary|Change in High Sensitivity C-Reactive Protein (Hs-CRP)|Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation|4 weeks||||mg/L||95% Confidence Interval|Geometric Mean
2726917|NCT01043939|Secondary|Change in Myeloperoxidase (MPO)|Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress|4 weeks||||ng/mL||95% Confidence Interval|Geometric Mean
2726918|NCT01043939|Secondary|Change in Oxidized LDL|Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress|4 weeks||||Units/Liter||Standard Error|Least Squares Mean
2726919|NCT01043939|Primary|Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)|"Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.~Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during & after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function."|4 weeks (change since baseline)|Intent-to-Treat analysis|||units on a scale||Standard Error|Least Squares Mean
2726920|NCT01043926|Secondary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
2726921|NCT01043926|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
2726922|NCT01043926|Primary|AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|Per protocol, the decision to perform AUC(0-∞) analysis in mild hepatic insufficiency participants was conditional on results of AUC(0-∞) analysis in moderate hepatic insufficiency participants. Since the primary hypothesis in moderate hepatic insufficiency participants was met, AUC(0-∞) analysis in mild hepatic insufficiency was not done.||||||
2726923|NCT01043926|Secondary|Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants|Cmax was defined as the maximum observed concentration of a drug after administration.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants|||μM||95% Confidence Interval|Geometric Mean
2726924|NCT01043926|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants|||μM•hr||95% Confidence Interval|Geometric Mean
2726925|NCT01043874|Secondary|Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set|||% participants w/ durable MMR at 24 mos||95% Confidence Interval|Number
2726926|NCT01043874|Secondary|Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set|||months||Standard Deviation|Mean
2726927|NCT01043874|Secondary|MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|24 months after treatment|Full Analysis Set|||% participants achieving MMR||95% Confidence Interval|Number
2726928|NCT01043874|Primary|MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later.|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|12 months after treatment|Full Analysis Set|||% participants achieving MMR||95% Confidence Interval|Number
2726929|NCT01043705|Primary|CIED Mechanical Complication|All mechanical Complications related to CIED Implant|12 months|"TYRX implants vs. published comparator are prospective arm patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort."|||percentage of Participants||95% Confidence Interval|Number
2726930|NCT01043705|Primary|Major CIED Infection|CIED Major Infections|12 months|Evaluable patients that have valid entry criteria|||percentage of Participants||95% Confidence Interval|Number
2726931|NCT01043653|Secondary|Maryland Assessment of Recovery in Serious Mental Illness|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~ 1-year||||units on a scale||Standard Deviation|Mean
2726932|NCT01043653|Primary|Positive and Negative Symptom Scale (PANSS)|The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.|~1-year|The PANSS had additional missing data from 3 participants|||units on a scale||Standard Deviation|Mean
2726933|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|One year||||percentage of donor cells||Standard Deviation|Mean
2726939|NCT01043640|Secondary|Number of Patients With Grade 4 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
2726940|NCT01043640|Secondary|Number of Patients With Grade 3 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
2726941|NCT01043640|Secondary|Number of Patients With Grade 2 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
2726942|NCT01043640|Secondary|Number of Patients With Grade 1 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
2726943|NCT01043640|Secondary|Number of Patients With Grade 0 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
2726944|NCT01043640|Primary|Number of Patients With Donor Derived Engraftment|Donor derived engraftment is defined as 80 percent or greater donor cells in the recipient's bone marrow and blood cells.|Day 100 Post Transplant||||Participants|||Count of Participants
2726945|NCT01043562|Secondary|Intrinsic Heart Rate in the Immediate Post-defibrillation Period|A patient will be considered to have an intrinsic slow heart rate in the period of time immediately following defibrillation (20 seconds) if any of the following are observed: >7 paced beats, asystole >4 seconds, or experienced >10% decrease in systolic blood pressure.|During clinical ICD procedure, as a single event|Post-defibrillation episodes in which intrinsic rhythm was evaluable and pacing was necessary|||episodes|Post-defibrillation episodes||Number
2726946|NCT01043562|Secondary|Do DFTs Vary by Type of ICD Systems Implanted?|The defibrillation threshold (as measured in Joules as already described in the details regarding the primary outcome) will be compared between patients with two distinct general types of implanted defibrillator systems: 1) transvenous ICD systems (defibrillator leads located inside the vein and attached to the endocardial surface of the heart) and 2) non-transvenous ICD systems (including all other types of debrillation systems).|During clinical ICD procedure, as a single event||||Joules||Inter-Quartile Range|Median
2726947|NCT01043562|Primary|Defibrillation Threshold|The defibrillation threshold is a measure of the minimum amount of energy (in Joules) that is able to successfully defibrillate an episode of ventricular fibrillation. This measurement is specific to each individual patient with his/her specific defibrillator configuration. There are several different strategies to measuring this in an individual patient; this study utilized the binary search protocol.|During clinical ICD procedure, as a single event||||Joules||Inter-Quartile Range|Median
2726948|NCT01043523|Other Pre-specified|Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726949|NCT01043523|Other Pre-specified|Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726950|NCT01043523|Other Pre-specified|Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726951|NCT01043523|Other Pre-specified|Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726952|NCT01043523|Other Pre-specified|Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726978|NCT01043133|Primary|Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record|The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).|immediately after invervention and 30+ days in follow-up||||participants|||Number
2726953|NCT01043523|Secondary|Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.|Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Percentage points|||Number
2726954|NCT01043523|Secondary|Final Diagnosis (SoT) by Clinical Investigator||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726955|NCT01043523|Secondary|The Overall Image Quality for the Postcontrast Image Only||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726956|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management / Therapy - Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented)||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.|||Participants|||Number
2726957|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726958|NCT01043523|Secondary|Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726959|NCT01043523|Secondary|Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726960|NCT01043523|Secondary|Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726961|NCT01043523|Secondary|Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
2726962|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast|||mmHg||Standard Deviation|Mean
2726963|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast|||mmHg||Standard Deviation|Mean
2726964|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Heart Rate||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast|||beats/min||Standard Deviation|Mean
2726965|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection|The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.|Up to 24 hours post-Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected|||Participants|||Number
2726966|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point|Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.|14 days prior to Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected|||Participants|||Number
2726979|NCT01043094|Secondary|Number of Participants With Treatment Emergent Adverse Events||3 Days||||Participants|||Number
2726967|NCT01043523|Primary|Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.|Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Percentage of participants||95% Confidence Interval|Number
2726968|NCT01043432|Primary|Iowa Gambling Test|Iowa Gambling Test - Total Raw Score The Iowa Gambling task requires examinees to sit in front of a computer screen displaying four decks of cards (Decks A, B, C, and D) and select a card from any of the four decks. Decks A and B are the disadvantageous decks because they produce high immediate gains however over time examinees will experience a higher loss. Decks C and D are the advantageous decks because they produce lower gains but over time examinees will experience smaller losses. Examinees will make 100 choices (trials). To measure performance, the 100 trials are divided, in order, into 5 'blocks' of 20. A net score is calculated for each block as the number of cards selected from the advantageous decks minus the disadvantageous decks and the total raw score is the sum of the scores for blocks 1-5. The overall total score can range from -100 (worst outcome) to 100 (best outcome)and the score for each block can range from -20 to 20|One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description.||||Total Raw on a scale from -100 to 100||Standard Deviation|Mean
2726969|NCT01043393|Secondary|Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis|The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|28 days|No statistical analysis provided for Percentage of Participants With a Physician’s Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|||percentage of physician’s global assessm||Standard Deviation|Mean
2726970|NCT01043393|Secondary|Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis|"Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600)~BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~%Body Surface Area Affected the Rule of Nine was be used"|28 days|"No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis.~As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected"|||percentage of Body Surface Area Affected||Standard Deviation|Mean
2726971|NCT01043393|Primary|Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression|Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.|28 days||||participants|||Number
2726972|NCT01043185|Secondary|Number of Weakly Alkaline Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||Full Range|Median
2726973|NCT01043185|Secondary|Number of Weakly Acidic Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||95% Confidence Interval|Geometric Mean
2726974|NCT01043185|Secondary|Number of Acid Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||95% Confidence Interval|Geometric Mean
2726975|NCT01043185|Primary|Total Number of Reflux Episodes During 24 Hours|Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||95% Confidence Interval|Geometric Mean
2726976|NCT01043146|Primary|The Number of Participants Reporting Adverse Events (AEs)|To assess the safety and tolerability of COR-1.|45 days||||Participants|||Number
2726977|NCT01043133|Secondary|Clinical Note Completeness Score|The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.|immediately after intervention and 30+ days in follow-up||||score||Standard Deviation|Mean
2726981|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg|To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value|||mmHg||95% Confidence Interval|Least Squares Mean
2726982|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
2726983|NCT01042977|Secondary|Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
2726984|NCT01042977|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2726985|NCT01042977|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values|||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
2726986|NCT01042977|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Number
2726987|NCT01042977|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
2726988|NCT01042938|Secondary|Pain at Radiation Treatment Site|The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.|4-7 weeks (prescribed course of radiation)|All 30 participants that fully completed the trial were used in these analyses.|||units on a scale||Standard Deviation|Mean
2726989|NCT01042938|Secondary|Redness at Radiation Treatment Site|Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.|4-7 weeks (prescribed course of radiation)|The 30 participants that fullt completed the trial were used in these analyses.|||units on a scale (0.0 to 20.0)||Standard Deviation|Mean
2726990|NCT01042938|Secondary|Moist Desquamation at Radiation Treatment Site|The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.|4-7 weeks (prescribed course of radiation)|All 30 participants who completed the trial were used in all analyses.|||participants|||Number
2726991|NCT01042938|Primary|Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients|The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.|4-7 weeks (prescribed course of radiation)|We used all 30 participants that fully completed the trial in all of our analyses.|||units on a scale||Standard Deviation|Mean
2726992|NCT01042795|Primary|Disease Free Survival|2-year disease free survival|2- year||||months|||Number
2726993|NCT01042678|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|All treated participants.|||Participants|||Number
2726994|NCT01042678|Secondary|Aqueous Humor Levels of MP0112|Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|1 Week|All treated participants who consented to participate.|||nM||Full Range|Median
2726995|NCT01042678|Secondary|Serum Levels of MP0112|Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|16 Weeks|All treated participants.|||Nanomolar (nM)||Full Range|Median
2726996|NCT01042678|Secondary|Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).|Baseline, Week 16|All treated participants.|||microns||Standard Deviation|Mean
2726997|NCT01042678|Secondary|Best-Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision.|Baseline, Week 16|All treated participants with data for a given time point were included for analysis.|||Letters||Standard Deviation|Mean
2726998|NCT01042678|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|16 weeks|All treated participants.|||Participants|||Number
2726999|NCT01042613|Secondary|Number of Skin Punctures|To assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique|At cannulation||||Skin punctures||Standard Deviation|Mean
2727000|NCT01042613|Secondary|Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).|To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique|At cannulation|Of the 146 patients, two patients were excluded due to missing time records.|||Minutes||Standard Deviation|Mean
2727001|NCT01042613|Primary|First Attempt Success Rate of Cannulation|This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.|At cannulation|Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.|||Participants|||Number
2727002|NCT01042600|Secondary|Mortality Rate||2 months||||participants|||Number
2727003|NCT01042600|Secondary|Complications During Insertion of LMA|LMA insertion complications (e.g. trauma, failure of insertion)|96 hrs||||Participants|||Count of Participants
2727004|NCT01042600|Secondary|Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)||2 months||||percentage of participants|||Number
2727005|NCT01042600|Secondary|Rate of Pneumothorax||96 hrs||||percentage of participants|||Number
2727006|NCT01042600|Secondary|Days on Supplemental Oxygen||2 months||||days||Inter-Quartile Range|Median
2727007|NCT01042600|Secondary|Days on Assisted Ventilation|Days on any respiratory support|2 months||||days||Inter-Quartile Range|Median
2727008|NCT01042600|Secondary|Number of Surfactant Doses|Mean number of surfactant doses|96 hr||||mean doses||Standard Deviation|Mean
2727009|NCT01042600|Primary|Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).||96 hours||||participants|||Number
2727010|NCT01042535|Other Pre-specified|Phase 2 - Change in Biomarker Level|Biomarkers include serum kynurenine, serum tryptophan, C reactive protein, and circulating T-regulatory cell levels (CD4+ 25+ CD127low forkhead box protein 3+ (FoxP3+). Appropriate t-tests and/or Wilcoxon test will be employed to study changes over time.|Baseline to week 16|||||||
2727011|NCT01042535|Secondary|Phase 2 - Median Progression Free Survival (PFS) in Weeks|Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS: Time from study entry to documentation of radiologic progressive disease or death, assessed up to 3 years.|Up to 3 years|All evaluable participants at time of analysis|||weeks||Full Range|Median
2727012|NCT01042535|Secondary|Phase 2 - Number of Participants With Clinical Benefit From Chemotherapy After Vaccination|Clinical response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years|All evaluable participants at time of analysis|||participants|||Number
2727013|NCT01042535|Secondary|Phase 1 - Number of Participants With Objective Response at 6 Weeks|Immunologic Response defined as Interferon-γ (IFN-γ) p53 T cell specific enzyme-linked immunospot (ELISPOT) assay count Summarized using both point estimates and the 95% exact confidence intervals based on the binomial distribution. Briefly, 2x10^5 mononuclear cells obtained from the peripheral blood of patients will be plated in quadruplicates in 96-well multiscreen mixed cellulose ester (HA) filtration plates, processed and incubated, spots will be visualized. The number of spots will be calculated per 10^6 cells. Untreated peripheral blood mononuclear cells (PBMNC) will represent a negative control and PBMNC stimulated with 10 µg/ml Concanavalin A (ConA) - positive control.|At 6 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod|||participants|||Number
2727014|NCT01042535|Primary|Phase 2 - Number of Participants With Stable Disease In Response to Study Therapy|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 16 weeks|All evaluable participants at time of analysis|||participants|||Number
2727015|NCT01042535|Primary|Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)|MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).|Up to 4 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod|||indoximod dose in mg|||Number
2727016|NCT01042509|Secondary|Side Effects|Percentage of participants who experienced side effects|365 days|15 consecutive patients were included for the analysis with periodical clinical evaluations to assess adverse effects.|||Participants|||Count of Participants
2727017|NCT01042509|Primary|Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.|Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up|30, 90 and 365 days|All consecutive patients were included in an intention to treat analysis to evaluate clinical response to alemtuzumab and rituximab combination.|||percentage of participants|||Number
2727018|NCT01042496|Secondary|Glutamine/Glutamate Ratio Measured in the LDLPC at Baseline Using the ProFit Magnetic Resonance Spectroscopy (MRS) Technique|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline|Sample sizes varied between both scanning locations LDLPC and MACC and between metabolites due to imaging results/scan viability. Some subject scans yielded more viable information/ less noise during the scan process. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis.|||ratio||Standard Deviation|Mean
2727019|NCT01042496|Secondary|Mean Glutamate (GLU) Measured in the MACC and LDLPC Using the ProFit MRS Technique at Baseline for Both Groups, After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline, 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=8, LDLPC n=8, Bipolar group MACC n=13, LDLPC n=13. Bipolar group 12 weeks MACC n=8, LDLPC n=17. The control group did not do the procedure at 12 weeks.|||Institutional Units (IU)||Standard Deviation|Mean
2727020|NCT01042496|Secondary|N-acetylaspartic Acid (NAA) Measured in the MACC and LDLPC Using the Long TE (TE80) PRESS MRS Technique at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar (BP) Group and BP Responders and Non-responders|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was used for statistical analysis.|baseline, 12 weeks|Samples varied due to imaging results/scan viability. Baseline: control group MACC (M) and LDLPC (L) n=8, BP whole M n=28 (3 didn't complete), L n=27, BP Responders M n=13, L n=11, BP nonresponders M and L n=12; BP whole 12 weeks M and L n=16. BP Responders M and L n=10, BP nonresponders M and L n=6. Controls didn't do the procedure at 12 weeks.|||Institutional Units (IU)||Standard Deviation|Mean
2727021|NCT01042496|Secondary|Glutamate+Glutamine (GLX) Measured in Mid Anterior Cingulate Cortex (MACC) & Left Dorsal Lateral Prefrontal Cortex (LDLPC) Using Long TE PRESS MRS Technique at Baseline for Both Groups; After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in in anterior cingulate and left dorsal lateral prefrontal cortex : an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of cerebrospinal fluid (CSF); the MRS voxel was overlaid onto the CSF map and the fraction of CSF was measured. This CSF corrected measurement was used for statistical analysis.|baseline, after 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=7, LDLPC n=8, Bipolar group MACC n=18, LDLPC n=27. Bipolar group 12 weeks MACC n=12, LDLPC n=16. The control group did not do the procedure at 12 weeks.|||Institutional Units (IU)||Standard Deviation|Mean
2727045|NCT01042236|Secondary|Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS|||Episodes per 24 hours.||Standard Deviation|Mean
2727022|NCT01042496|Primary|Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|The MADRS is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). A score of less than 12 is considered clinical remission of depression.|baseline, 12 weeks|The control group only did the MADRS depression rating scale at baseline. 25 participants in the Bipolar group took the MADRS depression rating scale at 12 weeks.|||units on a scale||Standard Deviation|Mean
2727023|NCT01042392|Secondary|Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|8 weeks + 1 day|All randomized patients except one patient from Aliskiren arm who was lost to follow up after visit 2.|||Participants|||Number
2727024|NCT01042392|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose|The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|From 8 weeks to 48 hours after week 8|Per-protocol missed dose population included all per protocol population patients who had received the study treatment for period 3 according to the protocol (duration of period 3 and treatment intake). Patients with observation at both time points were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2727025|NCT01042392|Secondary|Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)|"The sub-groups were: Riser = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night. The Non-risers in whom the difference is <55 mmHg. Patients called dippers in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients non-dippers  in whom this difference was <10%."|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at different categories were included in this analysis.|||mmHg||Standard Deviation|Mean
2727026|NCT01042392|Secondary|Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient. The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured.|At week 8|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM measurements over 24 hours were included in this analysis.|||mmHg||Standard Deviation|Mean
2727027|NCT01042392|Secondary|Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|Baseline to 4 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.|||mmHg||Standard Error|Least Squares Mean
2727028|NCT01042392|Secondary|Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient. The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient. The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time.|After 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM to evaluate the occurrence or absence of a morning peak were included in this analysis.|||Participants|||Number
2727029|NCT01042392|Secondary|Percentage of Patients With Controlled Blood Pressure|"The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings.~Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg."|At 4 and 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at each time point were included in this analysis.|||Percentage|||Number
2727044|NCT01042236|Secondary|Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.|||Percent||Full Range|Median
2727030|NCT01042392|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at both time points were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2727031|NCT01042392|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.|||mmHg||Standard Error|Least Squares Mean
2727032|NCT01042366|Primary|ELISpot Response to Melanoma|Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays.|12 mo|Patients who met inclusion criteria and received at least 3 doses of the vaccine|||participants|||Number
2727033|NCT01042366|Primary|Delayed Type Hypersensitivity (DTH) Response|Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo|12 mo|Patients who met inclusion criteria and received at least 3 doses of the vaccine|||participants|||Number
2727034|NCT01042288|Secondary|Frequency of Adverse Events and Severity as a Measure of Toxicity|Assessed using NCI CTCAE v4.0|Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter||||participants|||Number
2727035|NCT01042288|Secondary|Objective Response Rate||Projected 18 months|All patients evaluated for response|||percentage of evaluated participants|||Number
2727036|NCT01042288|Secondary|Median Overall Survival (OS)|Defined as the time between Day 1-Cycle 1 to the date of death from any cause.|18 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
2727037|NCT01042288|Secondary|Median Progression-free Survival (PFS)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression or death.|Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
2727038|NCT01042288|Primary|Median Time to Progression (TTP)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.|18 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
2727039|NCT01042236|Secondary|Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration|Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Baseline, Day 7 of each period|Full Analysis Set (FAS): all randomized subjects who had taken at least one dose of study treatment; (n)=number of participants with observations (non-missing concentrations)|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2727040|NCT01042236|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only subjects with >0 participants at baseline were to be included in the analysis.|||Percent||Full Range|Median
2727041|NCT01042236|Secondary|Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS|||Episodes per 24 hours.||Standard Deviation|Mean
2727042|NCT01042236|Secondary|Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.|||Percent||Full Range|Median
2727043|NCT01042236|Secondary|Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS|||Episodes per 24 hours.||Standard Deviation|Mean
2727046|NCT01042236|Secondary|Change From Baseline in Closing Urethral Elastance at Day 7|Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS|||cmH2O/mm^2||Standard Deviation|Mean
2727047|NCT01042236|Secondary|Change From Baseline in Opening Urethral Elastance at Day 7|Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS|||cmH2O/millimeter(mm)^2||Standard Deviation|Mean
2727048|NCT01042236|Secondary|Change From Baseline in Closing Urethral Pressure at Day 7|Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS|||cmH20||Standard Deviation|Mean
2727049|NCT01042236|Primary|Change From Baseline in Opening Urethral Pressure (OUP) at Day 7|OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.|||centimeter of water (cmH2O)||Standard Deviation|Mean
2727050|NCT01042158|Secondary|6-minute Walk Distance|patients were made to take a walk of normal speed to cover a distance in 6 minutes and distance covered was recorded. This was done at baseline (week o) and then repeated t 36 weeks.|baseline and 36 weeks||||meters||Standard Deviation|Mean
2727051|NCT01042158|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE)|The extent of displacement of the tricuspid valves, termed as Tricuspid Annular Plane Systolic Excursion (TAPSE) was measured using a trans-thoracic echocardiogram following Right heart catheterization.|baseline and 36 weeks||||cm||Standard Deviation|Mean
2727052|NCT01042158|Primary|Pulmonary Vascular Resistance (PVR)|Change in Pulmonary Vascular Resistance (PVR) was ascertained via Right Heart Catheterization (RHC) measurement of the difference between the PVR at baseline and 36 weeks|baseline 36 weeks||||Wood units||Inter-Quartile Range|Median
2727053|NCT01042158|Primary|Right Ventricular (RV) Mass|Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies.|baseline and 36 weeks||||grams||Inter-Quartile Range|Median
2727054|NCT01042145|Secondary|Number of Participants With Reported Side Effects||12 days||||percentage of participants|||Number
2727055|NCT01042145|Secondary|Time Missed From Work||12 days||||Hours||Standard Deviation|Mean
2727056|NCT01042145|Secondary|Parental Stress|Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.|12 days||||days||Standard Deviation|Mean
2727057|NCT01042145|Secondary|Nights With Disturbed Sleep||12 days||||nights||Standard Deviation|Mean
2727058|NCT01042145|Secondary|Duration of Croup Symptoms||12 days||||days||Standard Deviation|Mean
2727059|NCT01042145|Primary|Additional Health Care|The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.|11 days||||percentage of participants||95% Confidence Interval|Number
2727060|NCT01042093|Secondary|Knee Society Pain Scores at 6 Week Follow-up Appointment|Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.|6 weeks after surgery||||Scores on a scale 0-50||Full Range|Mean
2727061|NCT01042093|Secondary|Narcotic Consumption During Hospitalization|A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.|4 days||||mg||Standard Deviation|Mean
2727062|NCT01042093|Primary|Numerical Rating Scale (NRS) Pain Scores During Hospitalization.|Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.|2 days after surgery||||scores on a scale 0-10||Standard Deviation|Mean
2727063|NCT01041976|Secondary|Employment|"Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up.~Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up."|18 months||||participants|||Number
2727064|NCT01041976|Primary|Participation in Vocational Rehabilitation Services|"Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up.~Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up."|18 months||||participants|||Number
2727065|NCT01041859|Secondary|Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint|EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems. The health state index is a weighted combination of the 5 items. It has a range of 0 to 1, with 0=deceased and 1=full health.|Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.|||units on a scale||Standard Deviation|Mean
2727066|NCT01041859|Secondary|Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint|The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function. It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine. The pain intensity subscale score is defined as the mean of the scores from these 4 items.|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.|||units on a scale||Standard Deviation|Mean
2727067|NCT01041859|Secondary|Distribution of Patient Global Impression of Change at Week 12 Endpoint|Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is 'very much improved' and 7 is 'very much worse'|End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point|||percentage of participants|||Number
2727068|NCT01041859|Secondary|Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint|"The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating no pain and a score of 10 indicating pain as bad as you can imagine."|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation.|||percentage of participants|||Number
2727069|NCT01041859|Primary|Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12|"For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation|||units on a scale||Standard Deviation|Mean
2727070|NCT01041781|Secondary|Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)|Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 5 years|Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.|||months||95% Confidence Interval|Median
2727071|NCT01041781|Secondary|Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)|prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 5 years|Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.|||months||95% Confidence Interval|Median
2727072|NCT01041781|Secondary|Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)|Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 5 years|Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.|||months||95% Confidence Interval|Median
2727073|NCT01041781|Secondary|Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0|The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment|Up to 5 years||||percentage of patients|||Number
2727074|NCT01041781|Secondary|Response Rate|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
2727075|NCT01041781|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time between randomization and death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2727095|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
2727076|NCT01041781|Primary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time between randomization and disease relapse or death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2727077|NCT01041638|Secondary|Overall Survival (OS)|Overall Survival (OS) for all eligible patients enrolled on the study|From enrollment until death, or until last contact with the patient, up to 3 years|All eligible patients|||percentage||95% Confidence Interval|Number
2727078|NCT01041638|Secondary|Event-free Survival (EFS)|Event-free Survival (EFS) for all eligible patients enrolled on the study|From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years|All eligible patients.|||percentage||95% Confidence Interval|Number
2727079|NCT01041638|Primary|Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).|Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.|Up to 5 years|"There was one patient that did not receive treatment, represented on the baseline form as withdrawal by patient, not included in outcome measure tabulation."|||percentage of participants|||Number
2727080|NCT01041573|Secondary|Rate of Subjects With Abnormal Laboratory Parameters||study duration|||||||
2727081|NCT01041573|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7||Day 56 and up to Month 7|||||||
2727082|NCT01041573|Secondary|Rate of Subjects With Solicited Local and Systemic AEs||study duration|||||||
2727083|NCT01041573|Secondary|Rate of Subjects With SAEs and Medically Attended AEs up to Month 7||up to Month 7|||||||
2727084|NCT01041573|Secondary|Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies and SCR at Days 0, 56 and at Month 7||Day 0, 56 and at Month 7|||||||
2727085|NCT01041573|Primary|Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination|Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix|until Day 56||||percentage of participants||95% Confidence Interval|Number
2727086|NCT01041521|Secondary|Vascular Function|Carotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.|24 months||||m/s||Standard Deviation|Mean
2727087|NCT01041521|Primary|Triglyceride Level||24 months||||mg/dL||Inter-Quartile Range|Median
2727088|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
2727089|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
2727090|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
2727091|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
2727092|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
2727093|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
2727094|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
2727462|NCT01038713|Secondary|Determine the Days of Hospitalization Following Stent Placement|Number of total days of hospitalization for all patients in each group|From stent placement up to 500 days post stent||||Days|||Number
2727096|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
2727097|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
2727098|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
2727099|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
2727100|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 6 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 6 months||||seconds||95% Confidence Interval|Mean
2727101|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 3 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 3 months||||seconds||95% Confidence Interval|Mean
2727102|NCT01041417|Secondary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 6 months||||seconds||95% Confidence Interval|Mean
2727103|NCT01041417|Primary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 3 months||||seconds||95% Confidence Interval|Mean
2727104|NCT01041404|Secondary|Trastuzumab Maximum Serum Concentration (Cmax)|Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population|||mg/L||90% Confidence Interval|Median
2727105|NCT01041404|Secondary|Trastuzumab Minimum Serum Concentration (Cmin)|Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population|||mg/L||90% Confidence Interval|Median
2727106|NCT01041404|Secondary|Steady State Trastuzumab Area Under the Concentration (AUC)|Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.|||mg*day/L||90% Confidence Interval|Median
2727107|NCT01041404|Secondary|Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight|Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.|||percentage of participants|||Number
2727108|NCT01041404|Secondary|Body Weight (Kilograms [kg]) at BL||BL|FAS|||kg||Full Range|Median
2727109|NCT01041404|Secondary|Percentage of Participants With a Change in Analgesic Medication During the Study|Analgesic medications were recorded throughout the study until disease progression.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
2727110|NCT01041404|Secondary|Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)|"The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change indicated improvement."|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.|||mm||Standard Error|Mean
2727131|NCT01041209|Secondary|Treatment Failure in Each Group|"Treatment failure was defined as: Persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.~Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline)."|1, 2, 5, 7 and 10 days from baseline||||participants|||Number
2727132|NCT01041209|Primary|Use of Antibiotics in Each Group|The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).|At baseline||||participants|||Number
2727111|NCT01041404|Secondary|EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores|The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.|||scores on a scale||Standard Error|Mean
2727112|NCT01041404|Secondary|European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n (number) = number of participants assessed for a specific parameter at a given visit.|||scores on a scale||Standard Error|Mean
2727113|NCT01041404|Primary|Overall Survival - Time to Event|The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||months||95% Confidence Interval|Median
2727114|NCT01041404|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants||95% Confidence Interval|Number
2727115|NCT01041404|Secondary|Duration of Response|The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2727116|NCT01041404|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.|||percentage of participants|||Number
2727117|NCT01041404|Secondary|Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)|For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants||95% Confidence Interval|Number
2727118|NCT01041404|Secondary|Time to Progression - Time to Event|The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||months||95% Confidence Interval|Median
2727119|NCT01041404|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
2727120|NCT01041404|Secondary|Progression-Free Survival - Time to Event|The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||months||95% Confidence Interval|Median
2727133|NCT01040871|Secondary|Change in Fatigue and Patient Utility Scores||18-24 months|||||||
2727134|NCT01040871|Secondary|Overall Survival Rate at 1-year|Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.|1 year|Intent to Treat Population|||percentage of partipants||95% Confidence Interval|Number
2727135|NCT01040871|Secondary|Progression-free Survival (PFS)Rate at 1-year|Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.|1 year|Intent to Treat Population|||percentage of partipants||95% Confidence Interval|Number
2727121|NCT01041404|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
2727122|NCT01041404|Primary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
2727123|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|6 months||||meters per second (m/s)||Standard Deviation|Mean
2727124|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|3 months||||meters per second (m/s)||Standard Deviation|Mean
2727125|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|Baseline||||meters per second (m/s)||Standard Deviation|Mean
2727126|NCT01041274|Secondary|Heinrich Quality of Life Scale (QOL)|The Quality of Life Scale (QOL) is a 21-item scale based on a semi-structured interview to assess functional deficits in schizophrenia. Each item is rated on a 7-point scale where 0 indicates a normal level of functioning, or no deficit, and 6 corresponds to more severe deficit. The total score is a sum of all items. The minimum total score is 0 and the maximum total score is 126, higher scores indicate increased impairment in functioning.|Baseline, Week 4, 8, 12, 16, 20, 24, 32, 40, 52|Not all participants completed the QOL assessment at each time point. Results are reported for all participants who completed the QOL assessment.|||units on a scale||Standard Deviation|Mean
2727127|NCT01041274|Secondary|InterSePT Scale for Suicidal Thinking (ISST)|IntraSePT Scale for Suicidal Thinking (ISST) consists of 12 questions rated from 0 to 2 with increasing intensity (i.e. none, weak, moderate to stron). It quantifies the current conscious and overtly expressed suicidal thinking in schizophrenic patients by canvassing various suicidal thoughts and wishes during a 20- to 30-min semi-structured interview. The total score is computed by adding the 12 individual item scores and ranges from 0 to 24. A score of zero indicates low suicidal ideation and a score of 24 indicates high suicidal ideation.|Screening, Baseline, Weeks 1-8|Given the low scores on this assessment, data collection was discontinued.|||score on a scale||Standard Deviation|Mean
2727128|NCT01041274|Secondary|Brief Psychiatric Rating Scale (BPRS)|"The Brief Psychiatric Rating Scale (BPRS) is a 24-item rater-administered scale assessing overall psychiatric and psychotic symptoms. Items 1-14 are assessed through self-report and items 15-24 are assessed on the basis of observed behavior. Each item is rated from 1 to 7 where 1 is not present and 7 is extremely severe. A score of 0 indicates not assessed. The total score is a sum of all items and is reported for each time point. The minimum score is 24 and the maximum score is 168, and higher values indicate increased symptom severity."|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Not all participants completed the BPRS assessment at each time point. Results are reported for all participants who completed the BPRS assessment.|||units on a scale||Standard Deviation|Mean
2727129|NCT01041274|Secondary|Scale for the Assessment of Negative Symptoms (SANS)|"The Scale for the Assessment of Negative Symptoms (SANS) is a 25-item rater-administered scale to assess negative symptoms in schizophrenia. Each item is rated from 0 to 5 where 0 is none and 5 is severe. The SANS consists of five subscales: affective flattening/blunting, alogia, avolition/apathy, ahnedonia/asociality, and attention. Each subscale contains a global rating item which assesses the overall severity of symptoms within the subscale. The total score consists of a sum of all items except the global ratings and items 10, 23, 24, and 25. The total score is reported for each time point. The minimum total score is 0 and the maximum total score is 85. A higher score indicates increased severity of negative symptoms."|Screening, Baseline, Weeks 4, 8, 12, 16, 20, 24, 28,32, 36, 40, 44, 48, 52|Not all participants completed the SANS assessment at each time point. Results are reported for all participants who completed the SANS assessment.|||units on a scale||Standard Deviation|Mean
2727130|NCT01041274|Primary|Calgary Depression Scale for Schizophrenia (CDSS)|"The Calgary Depression Scale for Schizophrenia (CDSS) is a rater-administered assessment that measures depression in schizophrenia. The scale consists of 9 questions each rated 0 to 3. 0 corresponds with absent and 3 corresponds with severe. The total score for all items is provided for each time point. The minimum score is 0 and the maximum score is 27. A higher score indicates increased depressive symptoms."|Screening, Baseline, Weeks 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Not all participants completed the CDRS assessment at each time point. Results are reported for all participants who completed the CDRS assessment.|||units on a scale||Standard Deviation|Mean
2727405|NCT01039428|Secondary|Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL||baseline and end of the treatment|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.|||participants|||Number
2727136|NCT01040871|Secondary|Subsequent Anti-lymphoma Therapy Rate at 1-year|Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.|1 year|Intent to Treat Population|||percentage of participants||95% Confidence Interval|Number
2727137|NCT01040871|Secondary|Rate of Durable Complete Response|Proportion of subjects who achieved a CR with duration of at least 6 months|Median follow up approx 12 months||||percentage of participants||95% Confidence Interval|Number
2727138|NCT01040871|Secondary|Rate of Durable Response|Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.|Median follow up approx. 12 months||||percentage of participants||95% Confidence Interval|Number
2727139|NCT01040871|Secondary|Overall Response Rate|"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment|||percentage of participants||90% Confidence Interval|Number
2727140|NCT01040871|Primary|Complete Response (CR) Rate|"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PET scan was negative.~The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.~If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.~No new sites of disease were detected."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment|||percentage of participants||90% Confidence Interval|Number
2727141|NCT01040858|Secondary|Satisfaction With Life Scale|A brief measure of global life satisfaction. It measures the sum of satisfaction ratings for 5 items on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 5 to 35 with higher scores indicating greater satifaction.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727142|NCT01040858|Secondary|Severity of Dependence Scale|A brief substance dependence measure. It measures the sum of severity ratings for 5 symptoms on a scale from 0 (never) to 3 (always). The total score ranges from 0 15.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727143|NCT01040858|Secondary|Beck Depression Inventory, Second Edition|A depression symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severity ratings for 21 symptoms on a scale from 0 (none) to 3 (severe). BDI total score ranges from 0 to 63.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727144|NCT01040858|Secondary|PTSD Checklist-Military Version|A PTSD symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severit ratings for 17 symptoms on a scale from 1 (not at all) to 5 (extremely). PCL-M total score ranges from 17 to 85.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727145|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Verbal Fluency Subtest|A measure of verbal fluency, generativity, and processing speed. A scaled score of Letter Fluency portion of the test was used. The scores ranged from 0 to 20 with higher scores indicating better outcomes.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727146|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Trails Subtest|A visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Scaled score for Condition 4 was used, and possible scores ranges from 0 to 20 with higher scores indicating better outcome.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727147|NCT01040858|Secondary|Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest|A measure of attention and working memory. Total score was used, and it ranges from 0 to 48, with higher scores indicating greater attentional capacity.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727148|NCT01040858|Secondary|Hopkins Verbal Memory Test-Revised|Verbal list learning and delayed recall. Total recall T-score was used for the analyses. Total recall T-score ranges from 13 (severely impaired) to 86 (very superior).|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727435|NCT01039207|Other Pre-specified|Circulating Levels of HGF/Scatter Factor (SF)|Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).|Up to 1 day prior to course 2|||||||
2727149|NCT01040858|Secondary|Memory Compensation Questionnaire|The MCQ is a 44-item self-report questionnaire that rates the extent to which patients use various strategies to improve memory performance relevant to daily living. The MCQ measures the sum of memory strategies used on a scale from 0 (never) to 4 (always). The total score ranges from 0 to 176.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727150|NCT01040858|Secondary|The Neurobehavioral Symptom Inventory|A post-concussive symptom measure. The total score on the measure is the sum of severity ratings for 22 symptoms on a scale from 0 (none) to 4 (very severe). NSI total score ranges from 0 to 88.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727151|NCT01040858|Secondary|Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &|A 16-item self-report severity measure of prospective and retrospective memory problems relevant to everyday life. The measure reports the sum of severity ratings on a scale from 1 (never) to 5 (very often). The PRMQ total score ranges from 16 to 80.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727152|NCT01040858|Primary|Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version|A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
2727153|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2727154|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2727155|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng/mL||Standard Deviation|Mean
2727156|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2727157|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng-hr/mL||Standard Deviation|Mean
2727158|NCT01040845|Primary|Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss)|The maximum or peak concentration that Colchicine with Norethindrone/Ethinyl Estradiol reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2727159|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2727160|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2727161|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2727436|NCT01039207|Other Pre-specified|Biomarker Panel From Tumor Tissue|A panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.|Baseline|||||||
2727162|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2727163|NCT01040832|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Time from first dose up to Day 42 to 49 after last dose of trial treatment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|Safety population included all the participants who received at least 1 dose study drug.|||participants|||Number
2727164|NCT01040832|Secondary|Overall Survival (OS) Time|The overall survival (OS) time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment. Overall survival data was analyzed only for participants who received cetuximab plus EMD 1201081.|||months||95% Confidence Interval|Median
2727165|NCT01040832|Secondary|Percentage of Participants With Disease Control: Independent Read Assessments|Percentage of participants with disease control, defined as having achieved CR or PR or stable disease (SD) as the tumor response according to radiological assessments (based on RECIST Version 1.0 criteria), was reported. As per RECIST v1.0 for target lesions and assessed by MRI: CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.|||percentage of participants||95% Confidence Interval|Number
2727166|NCT01040832|Secondary|Percentage of Participants With Objective Response: Independent Read Assessments|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as assessed by Independent Read. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.|||percentage of participants||95% Confidence Interval|Number
2727167|NCT01040832|Primary|Progression-free Survival (PFS) Time: Independent Read Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event were censored on the date of last tumor assessment.|Every 6 weeks until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.|||months||95% Confidence Interval|Median
2727168|NCT01040819|Primary|Plasma 15-epi-lipoxin A4|Plasma 15-epi-LXA4 levels|2 months||||ng/ml||Standard Error|Mean
2727169|NCT01040793|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
2727170|NCT01040793|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
2727171|NCT01040793|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
2727172|NCT01040793|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||beats/min||Standard Deviation|Mean
2727173|NCT01040793|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||mmHg||Standard Deviation|Mean
2727174|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
2727175|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
2727176|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727177|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727178|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727179|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727180|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727181|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727182|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727183|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727184|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727185|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727186|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
2727187|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
2727188|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727189|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727190|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.~Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
2727454|NCT01038752|Secondary|Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes|Insufficient data.|Randomization date|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727191|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727192|NCT01040793|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||seconds||Standard Error|Geometric Mean
2727193|NCT01040780|Secondary|Safety and Tolerability|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.~Grade 3 = Severe Grade 4 = Life-threatening or disabling"|Assessed over two years||||participants|||Number
2727194|NCT01040780|Secondary|Time To Progression|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.|2-7 months||||months||95% Confidence Interval|Median
2727195|NCT01040780|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression||||percentage of patients|||Number
2727196|NCT01040780|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death||||months||95% Confidence Interval|Median
2727197|NCT01040780|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|2-7 months|All patients who received at least one dose of study drug with measurable disease at baseline.|||months||95% Confidence Interval|Median
2727198|NCT01040728|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.|||participants|||Number
2727199|NCT01040728|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment for the first period. Trough values were the mean of obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727200|NCT01040728|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment for the first period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727201|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727202|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data for this endpoint after first dose of treatment.|||Liter||Standard Error|Mean
2727203|NCT01040728|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727455|NCT01038752|Secondary|Pre-treatment bFGF Levels Correlation With Survival.|Insufficient data.|Before first treatment|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727204|NCT01040728|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727205|NCT01040728|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727206|NCT01040728|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment for the first period. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727207|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727208|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data for this endpoint after first dose of treatment.|||Liter||Standard Error|Mean
2727209|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727210|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the treatment at the first treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data for this endpoint after first dose of treatment.|||Liter||Standard Error|Mean
2727211|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose at the first randomized treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727221|NCT01040689|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727212|NCT01040728|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727213|NCT01040728|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either of the co-primary endpoints. FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
2727214|NCT01040689|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.|||percentage of participants|||Number
2727215|NCT01040689|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose in first treatment period. Trough values were mean of the values obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727216|NCT01040689|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose in first treatment period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727217|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727218|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data after first dose of treatment.|||Liter||Standard Error|Mean
2727219|NCT01040689|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727220|NCT01040689|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727232|NCT01040624|Primary|Acute Grade 3 or Higher Treatment-related Toxicity Rate.|Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.|6 months after the completion of radiation therapy||||participants|||Number
2752211|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||8 weeks|||||||
2727222|NCT01040689|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of first treatment period. Trough values were the mean of values obtained 23 hours and 23h 50min post the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727223|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727224|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data after first dose of treatment.|||Liter||Standard Error|Mean
2727225|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727226|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data after first dose of treatment.|||Liter||Standard Error|Mean
2727227|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the first visit of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727228|NCT01040689|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727229|NCT01040689|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either co-primary endpoint from the same treatment period. FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
2727230|NCT01040624|Secondary|Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.||After radiation: every 6 months for 3 years, then annually for 20 years|||||||
2727231|NCT01040624|Secondary|Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.||After radiation: every 6 months for 3 years, then annually for 20 years|||||||
2727582|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||52 weeks minus baseline||||mL/min/1.73m^2||Standard Deviation|Mean
2727233|NCT01040403|Secondary|Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry|Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29.|||mmHg||Standard Deviation|Mean
2727234|NCT01040403|Secondary|Pulse Rate Recorded in Conjunction With Spirometry|Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29.|||bpm||Standard Deviation|Mean
2727235|NCT01040403|Secondary|Patients Global Rating|"Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse"|Day 29|FAS|||units on a scale||Standard Error|Mean
2727236|NCT01040403|Secondary|Physicians Global Evaluation|"Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8"|Days 1 and 29|FAS|||units on a scale||Standard Error|Mean
2727237|NCT01040403|Secondary|Weekly Mean Number of Puffs of Rescue Medication Used Per Day|Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).|Weeks 1 and 4|FAS|||number of puffs per day||Standard Error|Mean
2727238|NCT01040403|Secondary|Individual PEF Measurements at Each Time Point on Day 29|Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS|||L/min||Standard Error|Mean
2727239|NCT01040403|Secondary|Individual FVC Measurements at Each Time Point on Day 29|Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
2727240|NCT01040403|Secondary|Individual FEV1 Measurements at Each Time Point on Day 29|Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
2727241|NCT01040403|Secondary|PEF Peak 0-3h Response After the First Dose|Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||L/min||Standard Error|Mean
2727242|NCT01040403|Secondary|PEF Peak 0-3h Response|Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS|||L/min||Standard Error|Mean
2727243|NCT01040403|Secondary|PEF AUC 0-3h Response After the First Dose|Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||L/min||Standard Error|Mean
2727244|NCT01040403|Secondary|PEF AUC 0-3h and AUC 0-6h Responses|Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS|||L/min||Standard Error|Mean
2727245|NCT01040403|Secondary|FVC Peak 0-3h Response After the First Dose|Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||Litres||Standard Error|Mean
2727246|NCT01040403|Secondary|FVC Peak 0-3h Response|Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
2727247|NCT01040403|Secondary|FVC AUC 0-3h Response After First Dose|Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1|FAS|||Litres||Standard Error|Mean
2727354|NCT01039688|Secondary|Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Deviation|Mean
2727248|NCT01040403|Secondary|FVC AUC 0-3h and FEV1 AUC 0-6h Responses|Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS|||Litres||Standard Error|Mean
2727249|NCT01040403|Secondary|FEV1 Peak 0-3h Response After the First Dose|Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||Litres||Standard Error|Mean
2727250|NCT01040403|Secondary|FEV1 Peak 0-3h Response|Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
2727251|NCT01040403|Secondary|FEV1 AUC 0-3h Response After the First Dose|Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||Litres||Standard Deviation|Mean
2727252|NCT01040403|Secondary|FEV1 AUC 0-3h and FEV1 AUC 0-6h Response|Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS|||Litres||Standard Deviation|Mean
2727253|NCT01040403|Secondary|Trough Forced Vital Capacity (FVC) Response|Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.|||Litres||Standard Error|Mean
2727254|NCT01040403|Primary|Trough FEV1 Response|Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.|||Litres||Standard Deviation|Mean
2727255|NCT01040351|Secondary|The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .|The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .|18 weeks after embryo transfer|Patients who underwent embryo transfer were included in the final analysis|||participents|||Number
2727256|NCT01040351|Primary|The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle|"The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound~)in a transfer cycle"|5 weeks after embryo transfer|Patients undergoing embryo transfer were included in final analysis|||participents|||Number
2727257|NCT01040260|Primary|Abstinence Rate|Number of participants who abstained from smoking during the 7 day period verified by CO testing|52 weeks||||participants|||Number
2727258|NCT01040208|Secondary|The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.|||participants|||Number
2727259|NCT01040208|Secondary|The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.|||participants|||Number
2727260|NCT01040208|Primary|The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.||17 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.|||participants|||Number
2727261|NCT01040169|Primary|Tooth Hypersensivity Stimuli to Air|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|12 weeks (Final)||||Units on a scale||Standard Deviation|Mean
2727463|NCT01038713|Secondary|Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.||Costs measured up to 500 days||||United States Dollars|||Number
2727262|NCT01040169|Primary|Tooth Hypersensitity to Touch Stimuli (Tactile)|Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity|12 weeks (Final)||||Units on a scale||Standard Deviation|Mean
2727263|NCT01040130|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
2727264|NCT01040130|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
2727265|NCT01040130|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
2727266|NCT01040130|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||beats/min||Standard Deviation|Mean
2727267|NCT01040130|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||mmHg||Standard Deviation|Mean
2727268|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
2727269|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
2727270|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727271|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727272|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727273|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727274|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727275|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727276|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727277|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727278|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727279|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727280|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
2727281|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2727282|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727283|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727284|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.~Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
2727285|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
2727286|NCT01040130|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||seconds||Standard Error|Geometric Mean
2727287|NCT01040052|Primary|Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine|Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2727288|NCT01039792|Primary|Clinical Global Impression-Improvement (CGI-I)|PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement.|8 weeks|comparing placebo vs active B12 subjects|||CGI- Improvement||Standard Deviation|Mean
2727289|NCT01039688|Secondary|Change From Baseline in Temperature||Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|Temperature was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline in temperature will be analyzed as part of the wider clinical program.|||degrees centigrade||Standard Deviation|Mean
2727290|NCT01039688|Secondary|Change From Baseline in Heart Rate||Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|Heart rate was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline will be analyzed as part of the wider clinical program.|||beats per minute||Standard Deviation|Mean
2727291|NCT01039688|Secondary|Change From Baseline in FACIT-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status|Months 1, 2, 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727355|NCT01039688|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Error|Least Squares Mean
2727292|NCT01039688|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status|Baseline and Months 1, 2, 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727293|NCT01039688|Secondary|Change From Baseline in MOS-SS at Months 6, 12, 18, and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Months 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727294|NCT01039688|Secondary|Change From Baseline in MOS-SS at Months 1, 2, and 3|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Months 1, 2, and 3|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2727295|NCT01039688|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Months 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727296|NCT01039688|Secondary|Percentage of Participants With Optimal Sleep Assessed Using MOS-SS|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported|Months 1, 2, 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||percentage of participants|||Number
2727297|NCT01039688|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Baseline and Months 1, 2, and 3|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727298|NCT01039688|Secondary|Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727299|NCT01039688|Secondary|Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
2727300|NCT01039688|Secondary|Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
2727352|NCT01039688|Secondary|Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly."|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Deviation|Mean
2727301|NCT01039688|Secondary|Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
2727302|NCT01039688|Secondary|Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
2727303|NCT01039688|Secondary|Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
2727304|NCT01039688|Secondary|Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
2727305|NCT01039688|Secondary|Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727306|NCT01039688|Secondary|Change From Baseline in Work Productivity and HCRU at Months 3 and 6|RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727307|NCT01039688|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727308|NCT01039688|Secondary|Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
2727309|NCT01039688|Secondary|Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6|RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
2727310|NCT01039688|Secondary|Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
2727311|NCT01039688|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
2727583|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||12 weeks minus baseline||||mL/min/1.73m^2||Standard Deviation|Mean
2727312|NCT01039688|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
2727313|NCT01039688|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
2727314|NCT01039688|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727315|NCT01039688|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727316|NCT01039688|Secondary|Change From Baseline in EQ-5D Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoints for each group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2727317|NCT01039688|Secondary|European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727318|NCT01039688|Secondary|Change From Baseline in WLQ Work Loss Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).|Months 3, 6, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a specific timepoint for each treatment group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2727319|NCT01039688|Secondary|WLQ Work Loss Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).|Baseline and Months 3, 6, and 12|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727320|NCT01039688|Secondary|Change From Baseline in WLQ Scores|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2727584|NCT01036490|Secondary|Change in Albuminuria||52 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
2727321|NCT01039688|Secondary|Work Limitation Questionnaire (WLQ) Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727322|NCT01039688|Secondary|Change From Baseline in SF-36 Domain Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2727323|NCT01039688|Secondary|SF-36 Domain Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727324|NCT01039688|Secondary|Change From Baseline in SF-36 Physical Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2727325|NCT01039688|Secondary|Change From Baseline in SF-36 Mental Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2727326|NCT01039688|Secondary|SF-36 Physical Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727327|NCT01039688|Secondary|Short Form 36 (SF-36) Mental Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727328|NCT01039688|Secondary|Percentage of Participants With at Least 0.5 Improvement in HAQ-DI|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727329|NCT01039688|Secondary|Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727456|NCT01038752|Secondary|Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.|Insufficient data.|Day 1 of each cycle; end of treatment visit; at follow-up.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2752212|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||Baseline|||||||
2727330|NCT01039688|Secondary|Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727331|NCT01039688|Secondary|Change From Baseline in HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2727332|NCT01039688|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727333|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
2727334|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
2727335|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits|ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
2727336|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits|ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
2727337|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits|ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
2727338|NCT01039688|Secondary|Percentage of Participants With an ACR70 Response Sustained at Least 6 Months|ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
2727339|NCT01039688|Secondary|Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727353|NCT01039688|Secondary|Change From Baseline in Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Error|Least Squares Mean
2727340|NCT01039688|Secondary|Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727341|NCT01039688|Secondary|Percentage of Participants With DAS28-4(ESR) <2.6|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727342|NCT01039688|Secondary|Percentage of Participants With DAS28-3(CRP) <2.6|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727343|NCT01039688|Secondary|Percentage of Participants With DAS28-4(ESR) ≤3.2|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727344|NCT01039688|Secondary|Percentage of Participants With DAS28-3(CRP) ≤3.2|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2727345|NCT01039688|Secondary|Change From Baseline in DAS28-4(ESR)|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2727346|NCT01039688|Secondary|Change From Baseline in DAS28-3(CRP)|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2727347|NCT01039688|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727348|NCT01039688|Secondary|Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
2727349|NCT01039688|Secondary|Change From Baseline in CRP|Change from Baseline in CRP measured in mg/L.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS|||mg/L||Standard Error|Least Squares Mean
2727350|NCT01039688|Secondary|C-Reactive Protein|CRP measured in milligrams per liter (mg/L)|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mg/L||Standard Deviation|Mean
2727351|NCT01039688|Secondary|Change From Baseline in Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly."|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Error|Least Squares Mean
2727457|NCT01038752|Secondary|Overall Response Rate (Complete Response + Partial Response) of Participants|Insufficient data|Tumor assessment at every other cycle|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727356|NCT01039688|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Deviation|Mean
2727357|NCT01039688|Secondary|Change From Baseline in SJC|Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||swollen joints||Standard Error|Least Squares Mean
2727358|NCT01039688|Secondary|Swollen Joints Count (SJC)|Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||swollen joints||Standard Deviation|Mean
2727359|NCT01039688|Secondary|Change From Baseline in TJC|Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||tender joints||Standard Error|Least Squares Mean
2727360|NCT01039688|Secondary|Tender Joints Count (TJC)|Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||tender joints||Standard Deviation|Mean
2727361|NCT01039688|Secondary|Percentage of Participants Achieving an ACR50 Response|ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI)|||percentage of participants|||Number
2727362|NCT01039688|Secondary|Percentage of Participants Achieving an ACR20 Response|ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI)|||percentage of participants|||Number
2727363|NCT01039688|Secondary|Percentage of Participants Achieving an ACR70 Response|ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 1, 2, 3, 9, 12, 15, 18, 21, and 24|FAS (NRI)|||percentage of participants|||Number
2727364|NCT01039688|Secondary|Change From Baseline in JSN Scores|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Months 6, 12, and 24|FAS, imputation using LEP|||units on a scale||Standard Error|Least Squares Mean
2727403|NCT01039428|Secondary|Serum Inorganic Phosphorus Level|Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
2727365|NCT01039688|Secondary|Change From Baseline in Erosion Scores|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Months 6, 12, and 24|FAS, imputation using LEP|||units on a scale||Standard Error|Least Squares Mean
2727366|NCT01039688|Secondary|JSN Scores|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.|Baseline, Months 6, 12, and 24|FAS, imputation using LEP|||score on a scale||Standard Deviation|Mean
2727367|NCT01039688|Secondary|Erosion Scores|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.|Baseline, Months 6, 12, and 24|FAS, imputation using LEP|||units on a scale||Standard Deviation|Mean
2727368|NCT01039688|Secondary|Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.|Months 6, 12, and 24|FAS (LEP)|||percentage of participants|||Number
2727369|NCT01039688|Secondary|Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.|Months 6, 12, and 24|FAS (LEP); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||percentage of participants|||Number
2727370|NCT01039688|Secondary|Change From Baseline in mTSS Score at Months 12 and 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Months 12 and 24|FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||score on a scale||Standard Error|Least Squares Mean
2727371|NCT01039688|Secondary|mTSS Score at Baseline, Months 12 and 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).|Baseline, Months 12 and 24|FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||score on a scale||Standard Deviation|Mean
2727372|NCT01039688|Primary|Change From Baseline in BP Values (mmHg)|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Months 1, 2, 3, 6, 9, 12, 15, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||mmHg||Standard Deviation|Mean
2727373|NCT01039688|Primary|Absolute Blood Pressure (BP) Values (mmHg)|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||mmHg||Standard Deviation|Mean
2727374|NCT01039688|Primary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).|Month 6|FAS. Missing values due to participant withdrawal were imputed using nonresponder imputation (NRI) method.|||percentage of participants|||Number
2727375|NCT01039688|Primary|Change From Baseline at Month 6 in mTSS|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Month 6|FAS, imputation using LEP|||score on a scale||Standard Error|Least Squares Mean
2727376|NCT01039688|Primary|Modified Total Sharp Score (mTSS) at Month 6|mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).|Month 6|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690,550) or MTX (in MTX-naive participants) with a baseline (BL) and at least 1 nonmissing on-study assessment. Missing values due to withdrawal were imputed using linear extrapolation (LEP) of BL/post-BL value before withdrawal.|||score on a scale||Standard Error|Least Squares Mean
2727404|NCT01039428|Secondary|Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P＜5.5 mg/dL at Week 3||week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||participants|||Number
2727377|NCT01039675|Secondary|Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 28|Pulse rate is defined as the number of heartbeats in a minute (m). A maximum post-Baseline pulse rate was derived as the maximum value recorded at Days 1, 14 and 28. A minimum post-Baseline pulse rate was derived as the minimum value recorded at Days 1, 14 and 28. The maximum and minimum pulse rates were calculated using the 0 to 6 hours (h) post dose measurements on Days 1, 14 and 28, which included pre-dose, and post-dose 15 m, 45 m, 1.5 h, 3 h and 6 h. Maximum and minimum post-Baseline rate were calculated using the nominal 0-6 h post-dose records, and only records collected during the actual 0-7 h post-dose interval were used. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the maximum or minimum pulse rate minus the Baseline value. Analysis performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, Day 14 and Day 28|ITT Population. The overall number of participants presented is the number who provided at least one post-Baseline assessment of 0-6 hours maximum or minimum pulse rate. Those participants who provided data at the indicated time point are represented by n=X, X in the category titles.|||Beats per minutes||Standard Error|Least Squares Mean
2727378|NCT01039675|Secondary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 1 and Day 14|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements on Day 1 and Day 14, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 1 or Day 14 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, and Day 14|ITT Population. All participants with >=1 post-BL assessment are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.|||Beats per minutes||Standard Error|Least Squares Mean
2727379|NCT01039675|Primary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements at Day 28, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 28 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline and Day 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >= 1 dose of randomized study medication. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 28.|||Beats per minutes (bpm)||Standard Error|Least Squares Mean
2727380|NCT01039584|Secondary|Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth)|Visit 3: Day 22-31||||participants|||Number
2727381|NCT01039584|Secondary|Clinical Cure|"Clinical cure (clinical success) was defined as follows:~All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure~A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)~The subject did not require additional vulvovaginal or systemic antifungal therapy~The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products"|Visit 3: Day 22-31|per-protocol|||participants|||Number
2727382|NCT01039584|Primary|The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.|Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)|Visit 3: Day 22-31|per-protocol|||participants|||Number
2727383|NCT01039519|Secondary|Count of Participants With Treatment-Emergent Adverse Events (AEs)|"Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.~Dose modification includes dose delay and dose reduction."|Day 1 up to Week 51|Full analysis set|||participants|||Number
2727384|NCT01039519|Secondary|Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)|PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999]. Tumor response was considered a complete response (CR) or a partial response (PR).|Day 2 to Day 10|Participants from one investigative site who provided consent for the PET/CT imaging.|||percentage of participants|||Number
2727385|NCT01039519|Secondary|Kaplan-Meier Estimate of Overall Survival|Overall survival was defined as the time from first dose to death or the date last known alive.|Day 1 up to week 97|Full analysis set|||months||95% Confidence Interval|Median
2752213|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||Baseline|||||||
2727386|NCT01039519|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|"PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as~at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or~the appearance of 1 or more new lesions or~the unequivocal progression of existing nontarget lesions"|Day 1 up to Week 47|Full analysis set|||months||95% Confidence Interval|Median
2727387|NCT01039519|Secondary|Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0|"Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.~CR: disappearance of all target lesions and non-target lesions and no new lesions~PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set|||percentage of participants|||Number
2727388|NCT01039519|Primary|Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|"Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.~CR: disappearance of all target lesions and non-target lesions and no new lesions~PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set which included participants receiving at least one dose of study medication.|||percentage of participants|||Number
2727389|NCT01039467|Secondary|Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)||1 month post-implantation|all participants who completed the 1 month visit with %VP data available.|||percent of ventricular pacing (%VP)||Standard Deviation|Median
2727390|NCT01039467|Secondary|Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)||1 month post-implantation|all participants who completed the 1 month visit with %VP data available.|||percent of ventricular pacing (%VP)||Standard Deviation|Median
2727391|NCT01039467|Secondary|Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)||1 month post-implantation|all participants who completed the 1 month visit with %VP data available.|||percent of ventricular pacing (%VP)||Standard Deviation|Median
2727392|NCT01039467|Secondary|Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)||1 month post-implantation|all participants who completed the 1 month visit with %VP data available.|||Participants|||Count of Participants
2727393|NCT01039467|Secondary|Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)||1 month post-implantation|all participants who completed the 12 months visit with %VP data available.|||Participants|||Count of Participants
2727394|NCT01039467|Secondary|Change in Percent of Ventricular Pacing||from 1 month to 12 months post-implantation|all participants who completed the 12 months visit with %VP data available.|||percent of ventricular pacing (%VP)||Standard Deviation|Median
2727395|NCT01039467|Secondary|Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant|To compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients by measuring the percent burden of atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.|1 month post-implantation|"all participants who completed the 1 month visit with~%AT/AF burden data available."|||Percentage of decreasedAT/AF burden||Standard Deviation|Median
2727396|NCT01039467|Secondary|Percent of Ventricular Pacing||12 months post-implantation|all participants who completed the 12 months visit with %VP data available.|||percent of ventricular pacing (%VP)||Standard Deviation|Median
2727397|NCT01039467|Primary|Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+||1 month post-implantation|all participants who completed the 1 month visit with %VP data available.|||Participants|||Count of Participants
2727398|NCT01039428|Secondary|Serum Intact Fibroblast Growth Factor (FGF) 23 Level|Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||log10(pg/mL)||Standard Deviation|Mean
2727399|NCT01039428|Secondary|Serum Intact Parathyroid Hormone (PTH) Level|Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||pg/mL||Standard Deviation|Mean
2727400|NCT01039428|Secondary|Ca×P|Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/mL*mg/mL||Standard Deviation|Mean
2727401|NCT01039428|Secondary|Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])|Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
2727402|NCT01039428|Secondary|Salivary Inorganic Phosphorus Level|Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
2727458|NCT01038752|Secondary|Overall Survival of Participants|Insufficient Data|First treatment date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727406|NCT01039428|Primary|Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline|Change in serum inorganic phosphorus at the end of treatment from baseline|baseline and end of the chewing treatment during three week treatment period|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
2727407|NCT01039376|Secondary|Plasma Half-life (t1/2) of Ofatumumab|The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
2727408|NCT01039376|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.|Day 1 Month 1 ( Cycle 1) through Month 7 ( Cycle 4)|PK Population. Only those participants available at the indicated time points were analyzed.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2727409|NCT01039376|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||micrograms*hour per mL (µg*hour/mL)||Geometric Coefficient of Variation|Geometric Mean
2727410|NCT01039376|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||millileters per hour (mL/hour)||Geometric Coefficient of Variation|Geometric Mean
2727411|NCT01039376|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2727412|NCT01039376|Secondary|Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers|Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=CY G.|From Baseline until the end of the study (up to 79 months)|ITT Population|||Participants|||Number
2727413|NCT01039376|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every two months from Month 3 until Month 25 and at every followup (up to 88 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Cells per microliter||Standard Deviation|Mean
2727414|NCT01039376|Secondary|Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.|From randomization until the end of the study (up to 88 months)|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Number
2727415|NCT01039376|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value.|Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 88 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||grams per liter||Standard Deviation|Mean
2727459|NCT01038752|Primary|Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria|Insufficient data|Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727585|NCT01036490|Secondary|Change in Albuminuria||12 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
2727416|NCT01039376|Secondary|Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result|All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.|Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.|||Participants|||Number
2727417|NCT01039376|Secondary|Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From randomization until the end of the study (up to 88 months)|Safety Population|||Participants|||Number
2727418|NCT01039376|Secondary|Number of Participants Who Received at Least One Transfusion During the Study|Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.|From randomization until the end of the study (up to 88 months)|Safety Population|||Participants|||Number
2727419|NCT01039376|Secondary|Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points|Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia [low hemoglobin count], neutropenia [low neutrophil count], and thrombocytopenia [low platelet count]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until the end of the study for SAEs (88 months)|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
2727420|NCT01039376|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until end of study for SAEs (88 months)|Safety Population|||Participants|||Number
2727421|NCT01039376|Secondary|Number of Participants With Grade 3 and Above Adverse Event of Infection|Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)|Safety Population: all participants who were randomized in the study and analyses were done based on the treatment the participant received regardless of how they were randomized.|||Participants|||Number
2727422|NCT01039376|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points|Participants with the indicated constitutional or B-symptoms (night sweats [without signs of infection]; unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of > 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of participants with no night sweats, no weight loss, no fever and no extreme fatigue were summarized.|From Screening until the end of the study (up to 88 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Participants|||Number
2727423|NCT01039376|Secondary|Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points|Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). Improvement in ECOG performance status was measured.|From randomization until the end of the study (up to 88 months)|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2727424|NCT01039376|Secondary|Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.|From screening until the end of the study (up to 47 months)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2727460|NCT01038713|Secondary|Assess Rate of Acute Cholecystitis Associated With Each Type of Stent||time from stent placement to 500 days||||Participants|||Number
2727461|NCT01038713|Secondary|Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents|Total number of days in which neoadjuvant therapy was delayed due to stent related issues|Time from stent placement to 500 days||||Days|||Number
2727425|NCT01039376|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from poor (worse quality of life) to excellent (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA."|From randomization until the end of the study (up to 47 months)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2727426|NCT01039376|Secondary|Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single-item scales (social activities [Social Problems (SP) Scale] and future health worries [Future Health (FH) Scale]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).|From randomization until the end of the study (up to 47 months)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2727427|NCT01039376|Secondary|Time to Progression After Next-line Therapy|Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.|From randomization until progression or death (up to 88 months)|ITT Population. Only participants who received next-line therapy and who also had PD prior to next line therapy were analysed. Participants who died prior to next-line therapy were also included for analysis.|||Months||95% Confidence Interval|Median
2727428|NCT01039376|Secondary|Progression-free Survival After Next-line Therapy|Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.|From randomization until progression or death (up to 88 months)|ITT Population. Only participants who received next-line therapy and subjects who died prior to receiving next-line therapy were analyzed.|||Months||95% Confidence Interval|Median
2727429|NCT01039376|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.|From randomization until the end of the study (up to 88 months)|ITT Population|||Months||95% Confidence Interval|Median
2727430|NCT01039376|Secondary|Number of Participants With Improvement in Response From Baseline|Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.|From Baseline until the end of the study (up to 88 months)|ITT Population. Only participants who had PR at study entry were analyzed.|||Participants|||Number
2727431|NCT01039376|Secondary|Overall Survival|Overall survival is defined as time from randomization to date of death.|From randomization until death (up to 88 months)|ITT Population|||Months||95% Confidence Interval|Median
2727432|NCT01039376|Primary|Progression-free Survival, as Assessed by the Independent Review Committee (IRC)|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 79 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.|||Months||95% Confidence Interval|Median
2727433|NCT01039376|Primary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 79 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.|||Months||95% Confidence Interval|Median
2727434|NCT01039207|Other Pre-specified|Circulating Levels of Markers of Angiogenesis|Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).|Up to 1 day prior to course 2|||||||
2727437|NCT01039207|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.|Eligible and treated patients|||months||90% Confidence Interval|Median
2727438|NCT01039207|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients. Measure type = The first quartile of the distribution since follow-up time is insufficient to obtain adequate median estimates.|||months||90% Confidence Interval|Number
2727439|NCT01039207|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients.|||participants|||Number
2727440|NCT01039207|Primary|Progression-free Survival > 6 Months Using RECIST 1.0|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.|Eligible and treated patients|||participants|||Number
2727441|NCT01039207|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.|Eligible and treated patients.|||participants|||Number
2727442|NCT01038921|Primary|Metabolic Syndrome Components||3 years||||mmHg||Standard Deviation|Mean
2727443|NCT01038869|Secondary|Tolerability Assessments as Measured by the Number of Participants With Side Effects|Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus|16 weeks|per protocol|||participants|||Number
2727444|NCT01038869|Secondary|Percentage Change in Total Lesion Counts|Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).|Baseline to 16 weeks|per protocol|||percentage of total lesion count||Standard Deviation|Mean
2727445|NCT01038869|Secondary|Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution|The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%|Baseline to 16 weeks|per protocol|||percentage of participants|||Number
2727446|NCT01038869|Secondary|Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)|IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement|Baseline to16 weeks|per protocol|||percentage of participants|||Number
2727447|NCT01038869|Primary|Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)|IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.|Baseline to 16 weeks|Per protocol|||percentage of participants|||Number
2727448|NCT01038856|Secondary|Decrease of Mutant JAK2V617F Allele Burden||every 2 months until end of treatment and 12 months after end of treatment|did not achieve hematological response|||Participants|||Count of Participants
2727449|NCT01038856|Secondary|Improvement in Splenomegaly Size||4 months, end of treatment and 12 months end of treatment|no improvement in spleen size|||Participants|||Count of Participants
2727450|NCT01038856|Secondary|Toxicity||First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year||||Participants|||Count of Participants
2727451|NCT01038856|Primary|Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response||Day 15||||participants|||Number
2727452|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727453|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
2727586|NCT01036490|Primary|Change in Proteinuria||52 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
2727464|NCT01038713|Primary|Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.|Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement|Time of stent occlusion, attempted surgical resection or patient death to 300 days||||participants|||Number
2727465|NCT01038635|Secondary|Overall Response: Number of Participants With CR or CRi Response|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months||||participants|||Number
2727466|NCT01038635|Secondary|Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months||||percentage of participants|||Number
2727467|NCT01038635|Primary|Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)|DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.|3-8 week cycles, up to 24 weeks||||participants|||Number
2727468|NCT01038609|Secondary|Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
2727469|NCT01038609|Secondary|Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high).|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
2727470|NCT01038609|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
2727471|NCT01038609|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||minutes||95% Confidence Interval|Median
2727472|NCT01038609|Secondary|Participant's Global Assessment of Study Drug|The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
2727473|NCT01038609|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||scores on a scale||Standard Error|Least Squares Mean
2727587|NCT01036490|Primary|Change in Proteinuria||12 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
2727588|NCT01036438|Secondary|Change in Inflammatory Signs|Change in inflammatory signs|4 weeks|||||||
2727474|NCT01038609|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||scores on a scale||Standard Error|Least Squares Mean
2727475|NCT01038557|Secondary|Clinical Outcomes - Infections|Number of subjects who developed infections while hospitalized.|from time of randomization through hospital discharged, assessed up to 6 months||||Participants|||Count of Participants
2727476|NCT01038557|Secondary|Clinical Outcomes - Acute Respiratory Distress Syndrome|Number of subjects who developed acute respiratory distress syndrome while hospitalized.|from time of randomization through hospital discharged, assessed up to 6 months||||Participants|||Count of Participants
2727477|NCT01038557|Secondary|Number of Participants With Acute Renal Failure|Number of participants who developed acute renal failure while hospitalized.|from time of randomization through hospital discharged, assessed up to 6 months||||Participants|||Count of Participants
2727478|NCT01038557|Secondary|Clinical Outcomes - Ventilator Days||from time of randomization through hospital discharged, assessed up to 6 months||||days||Inter-Quartile Range|Median
2727479|NCT01038557|Secondary|Clinical Outcomes - ICU Days|Number of days admitted to the ICU during hospital admission|from time of randomization through hospital discharged, assessed up to 6 months||||days||Inter-Quartile Range|Median
2727480|NCT01038557|Secondary|Clinical Outcomes - Hospital Days|Clinical outcomes - Number of days admitted to the hospital within a 6 month window.|from time of randomization through hospital discharged, assessed up to 6 months||||days||Inter-Quartile Range|Median
2727481|NCT01038557|Secondary|Haptoglobin Levels 12 Hours After Transfusion|Haptoglobin levels after transfusion|12 hours after transfusion|Blood samples to measure haptoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.|||ng/mL||Inter-Quartile Range|Median
2727482|NCT01038557|Secondary|Free Hemoglobin Levels After Transfusion|Free hemoglobin levels 12 hours after transfusion|12 hours after transfusion|Blood samples to measure free hemoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.|||ug/mL||Inter-Quartile Range|Median
2727483|NCT01038557|Secondary|2,3 DPG Levels After Transfusion|2,3 DPG levels 12 hours after transfusion|12 hours post transfusion|Blood samples to measure 2,3 DPG levels could not be collected from all subjects 12 hours after transfusion or results were not measurable.|||g/L||Inter-Quartile Range|Median
2727484|NCT01038557|Primary|Tissue Oxygenation|Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.|Percentage of baseline (3 hours post transfusion compared to baseline)|Mean percent change in tissue oxygenation (StO2) over time is reported for subjects with continuous data. Data on subjects whose NIRS device fell off or there was discontinuity in recording were excluded.|||percentage of baseline||Standard Deviation|Mean
2727485|NCT01038336|Secondary|Change in Cues to Action Score|Cues to action is a construct from the Health Belief Model defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). In the current study it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater cues to action, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Cues to action was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating more Cues to action having been received at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
2727486|NCT01038336|Secondary|Change in Perceived Self-efficacy Score|Perceived Self-efficacy is a construct from the Health Belief Model defined as an individual's assessment of his/her ability to successfully adopt a health behavior. In the current study it assesses the extent to which the individual believes that he/she has the knowledge and abilities to protect hearing. Perceived Self-efficacy was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived self-efficacy, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Self-efficacy was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived self-efficacy at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
2727487|NCT01038336|Secondary|Change in Perceived Barriers Score|Perceived Barriers is a construct from the Health Belief Model defined as an individual's assessment of the influences that discourage adoption of a health behavior. In the current study it assesses the extent to which the individual perceives few negative influences to protecting hearing. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating fewer perceived barriers, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Barriers was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating fewer perceived barriers at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
2727516|NCT01037244|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
2727589|NCT01036438|Primary|Efficacy Will be Defined as Absolute Wound Size Reduction.|Efficacy will be defined as absolute wound size reduction.|8 weeks||||cm2||Standard Deviation|Mean
2727488|NCT01038336|Secondary|Change in Perceived Benefit Score|Perceived Benefit is a construct from the Health Belief Model defined as an individual's assessment of the positive consequences of adopting a health behavior. In the present study that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived benefit, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived benefit was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived benefit at follow-up.|Baseline and 1 month||||units on scale||Standard Deviation|Mean
2727489|NCT01038336|Secondary|Change in Perceived Severity Score|Perceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of the consequences of a condition if it is acquired. In the current study it assesses the extent to which the individual believes that a hearing loss would have negative consequences. Perceived Severity was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived severity, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Severity was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived severity at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
2727490|NCT01038336|Secondary|Change in Perceived Susceptibility Score|Perceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. In the current study it assesses the extent to which the individual feels vulnerable to hearing loss. Perceived Susceptibility was assessed with 5 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived susceptibility, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Susceptibility was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived susceptibility at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
2727491|NCT01038336|Secondary|Knowledge About Hearing Conservation Scale|Knowledge about hearing conservation was assessed with 16 items in the the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). It is a validated questionnaire that assesses knowledge about and attitudes toward hearing and hearing loss prevention. The Knowledge scale is scored as a percent correct, with a higher score indicating more knowledge. Data presented are for change in knowledge between baseline and 1-month follow-up computed such that a higher score indicates greater increase in knowledge.|Baseline and 1 month||||percent of correct answers||Standard Deviation|Mean
2727492|NCT01038336|Primary|Percentage of Time Spent at Sound Levels >80 Decibels|Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels|1 month||||percentage of time||Standard Deviation|Mean
2727493|NCT01038323|Secondary|Identification of Group Assignment|Subjects identifying group assignment correctly|week 21|Information not captured (unfortunately)|||participants|||Number
2727494|NCT01038323|Secondary|Change in Evoked Pain Scores|0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli|Baseline and Week 21 clinic visits||||units on a scale||Standard Error|Mean
2727495|NCT01038323|Primary|Change in Weekly Average Pain Intensity|Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)|Baseline and Week 21clinic visits||||units on a scale||Standard Error|Mean
2727496|NCT01038128|Primary|Brown Assessments of Belief Scale|The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.|Baseline to 12 weeks|This scale was only administered to participants with Body Dysmorphic Disorder. No participants with BDD completed the Baseline Visit and, therefore, no results were available to analyze.||||||
2727497|NCT01038128|Primary|Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale|The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||units on a scale||Standard Deviation|Mean
2727498|NCT01038128|Primary|Clinical Global Impression Scale|Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||units on a scale||Standard Deviation|Mean
2727499|NCT01038128|Primary|Ratings of Eating Pathology|"Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number 777 was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes."|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||units on a scale||Standard Deviation|Mean
2727500|NCT01038128|Primary|Number of Binge Eating and Self-induced Vomiting Episodes|Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||number of episodes||Standard Deviation|Mean
2727517|NCT01037244|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
2728631|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 4 weeks after drug administration|ITT|||Participants|||Number
2727501|NCT01037881|Secondary|Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit|"The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved.~For each body region, the investigator rated four clinical signs of AD using the following severity scale:~0 = none/absent~= mild~= moderate~= severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country."|Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)|Data was tabulated using an observed cases approach and therefore only contains data from participants who attended the specific visit.|||units on a scale||Standard Deviation|Mean
2727502|NCT01037881|Secondary|Number of Participants That Were Symptom Free Responders by Visit|Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) according to Investigator's global assessment of disease severity on trunk and limbs at the end of treatment.|At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)|Occurrences of early withdrawal, non-compliance, prohibited medication, missing application of study medication and participants missing visits resulted in not all participants being analyzed at all visits.|||Participants|||Count of Participants
2727503|NCT01037881|Secondary|Participants' Overall Assessment of Disease Severity|"Participants' overall assessment of disease severity on trunk and limbs (excluding the hands) was assessed at end of treatment by use of the following scale: clear, very mild, mild, moderate, severe.~The assessment was based on the condition of the disease at the time of the evaluation and not in relation to the condition at a previous visit."|At end of treatment (Day 28)||||Participants|||Count of Participants
2727504|NCT01037881|Secondary|Participants' Assessment of Pruritus on Trunk and Limbs|"Participants' assessment of pruritus on trunk and limbs was assessed at end of treatment by use of the scale below.~Absent - no itching~Mild - occasional, slight itching~Moderate - constant or intermittent itching which is not disturbing sleep~Severe - intolerable itching which is disturbing sleep~The assessment was based on the average degree of pruritus over the last 24 hours."|At end of treatment (Day 28)||||Participants|||Count of Participants
2727505|NCT01037881|Secondary|Number of Participants That Were Symptom Free Responders (LOCF)|"The IGA (Investigator's global assessment) of disease severity on the body (trunk and limbs excluding the hands) was assessed based on visual evaluation by use of the following definitions of severity:~0. Clear - no inflammatory signs of AD~Almost clear - just perceptible erythema, and just perceptible papulation/infiltration~Mild - mild erythema, and mild papulation/infiltration~Moderate - moderate erythema, and moderate papulation/infiltration~Severe - severe erythema, and-severe papulation/infiltration~Very severe - severe erythema, and severe papulation/infiltration with oozing/crusting.~Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment."|At end of treatment (Day 28)||||Participants|||Count of Participants
2727506|NCT01037881|Primary|Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])|"The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved.~For each body region, the investigator rated four clinical signs of AD using the following severity scale:~0 = none/absent~= mild~= moderate~= severe~The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country."|Baseline (Day 0) and end of treatment (Day 28)||||units on a scale||Standard Deviation|Least Squares Mean
2727507|NCT01037452|Secondary|Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.||1 day||||participants|||Number
2727508|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day||||millimeters||95% Confidence Interval|Mean
2727509|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day||||millimeters||95% Confidence Interval|Mean
2727510|NCT01037452|Primary|Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal|Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.|1 day||||participants||95% Confidence Interval|Number
2727511|NCT01037309|Secondary|PRO044 Pharmacokinetic Cmax (μg/mL) Following Subcutaneous Administration|Pharmacokinetic population evaluated for maximum plasma concentration (Cmax)|Week 1, Week 5|Pharmacokinetic population evaluated|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2727512|NCT01037309|Primary|Safety and Tolerability of PRO044|number of subjects with 1 or more treatment emergent adverse events following SC or IV PRO044|During the 5 weeks of treatment and during the 13 weeks after treatment||||Participants|||Count of Participants
2727513|NCT01037309|Primary|Increase in Dystrophin Expression in the Muscle Biopsies by Immunofluorescence Analyses of Cross-sections and by Western Blot Analyses of Total Protein Extracts||Within 13 weeks after 5 weeks of treatment|For some participants it was not possible to determine dystrophin expression in muscle biopsy|||Participants|||Count of Participants
2727514|NCT01037244|Primary|Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
2727515|NCT01037244|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
2727518|NCT01037244|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
2727519|NCT01037244|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
2727520|NCT01037244|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0 (poor) - 5/(good) scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
2727521|NCT01037244|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
2727522|NCT01037244|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population|EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline to Week 12|mITT Population|||units on a scale||95% Confidence Interval|Least Squares Mean
2727523|NCT01037244|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)|Baseline to Week 12|mITT Population|||units on a scale||95% Confidence Interval|Least Squares Mean
2727524|NCT01037244|Secondary|Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population||Week 12|mITT Population|||participants|||Number
2727525|NCT01037244|Primary|Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
2727526|NCT01037244|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
2727527|NCT01037218|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
2727528|NCT01037218|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
2727529|NCT01037218|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
2727530|NCT01037218|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity|Baseline and Week 12|mITT|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727544|NCT01037127|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until death due to any cause (up to 134 weeks)|All Treated Population|||Months||95% Confidence Interval|Median
2727531|NCT01037218|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT|EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727532|NCT01037218|Secondary|Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population|While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)|Week 12|mITT|||Yes Responders|||Number
2727533|NCT01037218|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727534|NCT01037218|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727535|NCT01037218|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727536|NCT01037218|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727537|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage of Yes Responses||95% Confidence Interval|Least Squares Mean
2727538|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage of Yes Reponses||95% Confidence Interval|Least Squares Mean
2727539|NCT01037218|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2727540|NCT01037192|Secondary|Microbiological Efficacy|Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.|5 days||||participants|||Number
2727541|NCT01037192|Primary|Clinical Efficacy|Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.|5 days||||participants|Participants||Number
2727542|NCT01037127|Secondary|Number of Participants With Tumor Progression|Tumor progression was assessed as disease progression (DP), defined as at least a 20 percent increase in the sum of diameters of target lesions (representative of all involved organs), taking as reference the smallest sum on study; unequivocal progression of non-target lesions; or the appearance of a new lesion. Because melanoma often progresses to the brain/central nervous system (CNS) and this study enrolled approximately 20% participants with prior brain metastases, tumor progression in the brain/CNS was summarized. Paticipants could have been included in more than one category.|Baseline (Day 1) until tumor progression (up to approximately 57 weeks)|All Treated Population|||Participants|||Number
2727543|NCT01037127|Secondary|Number of Participants Who Survived Until 6 Months, 12 Months and 24 Months From Baseline|Overall survival (defined as the time from the treatment start date until death due to any cause) data data are presented as the number of participants who were alive 6 months, 12 months and 24 months after Baseline. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Month 6, Month 12 and Month 24|All Treated Population|||Participants|||Number
2727590|NCT01036321|Secondary|Biomarkers of Disease Progression - Total Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||ng/dL||Full Range|Median
2727545|NCT01037127|Secondary|PFS in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|PFS was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Per RECIST version 1.1, PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred earliest. Brain metastasis is a cancer that has spread to the brain from another location of the body.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because this subgroup was stopped for futility and nearly all the participants progressed before 4 months.|||Months||95% Confidence Interval|Median
2727546|NCT01037127|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred first. Participants who had not progressed or died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population|||Months||95% Confidence Interval|Median
2727547|NCT01037127|Secondary|Duration of Tumor Response|Duration of tumor response is defined as the time from the first documented evidence of a CR or PR to disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause. No participants who were previously treated with BRAF inhibitors had a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions; thus, no duration of response data can be presented.|From the time of the first documented evidence of a confirmed CR or PR until disease progression or death due to any cause (up to approximately 40 weeks)|All Treated Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
2727548|NCT01037127|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. AE and serious AE (SAE) data were collected from the start of the investigational product and continued until the End of Treatment Visit. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study medication until 28 days after the last dose (up to 477 days)|All Treated Population|||Participants|||Number
2727549|NCT01037127|Secondary|Mean Plasma Concentrations|Human plasma samples were analyzed for trametinib using a validated analytical method.|Day 15, pre-dose, 0.5-2 hours (hrs) post-dose, 2-4 hrs post-dose, and 4-8 hrs post-dose; Week 4, pre-dose; Week 8, pre-dose; Week 12, pre-dose|Pharmacokinetic (PK) Population: all participants in the All Treated Population for whom PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2727550|NCT01037127|Primary|Number of Participants With Best Unconfirmed Response at the Time of the Interim Analysis (Week 8)|An interim analysis was performed using data collected approximately 12 and 13 weeks after the 30th participant was enrolled in the prior BRAF inhibitor and prior standard therapy groups, respectively. The best unconfirmed response by the investigator per RECIST version 1.1 was assessed. The study design permitted stopping the study for futility if <3 best confirmed responses were observed in the first 30 participants of each treatment arm after completing the first post-dose assessment at Week 8. Best response was measured as either a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions.|Week 8|All Treated Population|||Participants|||Number
2727551|NCT01037127|Primary|Number of Participants With Best Confirmed Response in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|The number of participants with best confirmed response was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Objective response was assessed per RECIST version 1.1. Objective response was measured either as CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 mm, or PR, defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met. Brain metastasis is a cancer that has spread to the brain from another location of the body.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed CR or PR (up to approximately 25 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because there were no CRs or PRs among these participants.|||Participants|||Number
2727561|NCT01037114|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2728939|NCT01027273|Secondary|Access to Medical Care|Number of participants who have a primary care doctor|6 months post enrollment into trial|1 missing response from Usual Care group|||participants|||Number
2727552|NCT01037127|Primary|Number of Participants With Best Confirmed Response|Best confirmed response was assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Best response was measured either as a complete response (CR), defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters (mm), or a partial response (PR), defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed complete response or partial response (up to approximately 25 weeks)|All Treated Population: all participants who received at least one dose of investigational product|||Participants|||Number
2727553|NCT01037114|Secondary|Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to Year 20.|The LT Total cohort included all subjects who returned at each annual time point and who belonged to the Total cohort in the primary study.|||Subjects|||Number
2727554|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"One subject received a challenge dose of Havrix at Year 18 and another at Year 20.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.|||subjects|||Number
2727555|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Only 1 subject received a challenge dose at Year 16 of Engerix-B.~An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.|||Subjects|||Number
2727556|NCT01037114|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix.~An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine or Havrix.|||Subjects|||Number
2727557|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix|"Anti-HAV anamnestic response to the challenge dose was defined as:~Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point.~At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point.~Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point."|30 days after the challenge dose of Havrix.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.|||subjects|||Number
2727558|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B|"At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.~Anti-HBs anamnestic response to the challenge dose was defined as:~Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point.~At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point."|30 days after the challenge dose of Engerix-B.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.|||Subjects|||Number
2727559|NCT01037114|Secondary|Anti-HAV Concentrations After the Challenge Dose of Havrix|Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.|Before, 14 days and one month (30 days) after the challenge dose of Havrix.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.|||mIU/mL|||Number
2727560|NCT01037114|Secondary|Anti-HBs Concentrations After the Challenge Dose of Engerix-B|"Concentration was given in mIU/mL.~Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion."|Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.|||mIU/mL|||Number
2727581|NCT01036529|Primary|Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment||3, 6- and 12- months post-index procedure||||proportion of participants|||Number
2727562|NCT01037114|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.|||Subjects|||Number
2727563|NCT01037088|Secondary|Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis|The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). VAS Pain Intensity was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).|baseline to six hours||||units on a scale||Standard Deviation|Mean
2727564|NCT01037088|Primary|Participants With 30% or Greater Reduction in Pain Intensity|The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.|baseline to six hours|This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis.|||percentage of participants||95% Confidence Interval|Number
2727565|NCT01036802|Secondary|Major and Minor Bleeding Complications|We evaluated the safety of warfarin by evaluating for major and minor bleeding complications in study subjects|Evaluations were obtained at Screening, and at Months 3, 6, 9, and 12||||participants|||Number
2727566|NCT01036802|Secondary|All-cause Mortality|We assessed the effect of warfarin on mortality in the study subjects|Assessment was obtained until completion of study at 12 months||||participants|||Number
2727567|NCT01036802|Secondary|Endothelial Activation|We assessed the effect of warfarin on plasma measures of endothelial activation (soluble vascular cell adhesion molecule-1)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|As the number of subjects studied were very few, requiring discontinuation of the study, evaluation of endothelial activation was not performed.||||||
2727568|NCT01036802|Secondary|Platelet Activation|We evaluated the effect of anticoagulation with warfarin on platelet activation assessed by measuring plasma levels of soluble CD40 ligand|Measurements were obtained at Screening, Prior to Run-in, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.||||||
2727569|NCT01036802|Secondary|Thrombin Generation|We evaluated the effect of warfarin on a plasma measure of thrombin generation (thrombin-antithrombin complex)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.||||||
2727570|NCT01036802|Secondary|6-minute Walk Test|We evaluated the distance walked over 6 minutes. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, Months 3, 6, 9, and 12||||feet||Full Range|Mean
2727571|NCT01036802|Primary|Effect of Anticoagulation on Pulmonary Artery Systolic Pressure Was Obtained by Doppler Echocardiography|We determined the effect of anticoagulation with warfarin on estimated pulmonary artery systolic pressure obtained by Doppler echocardiography. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12||||mm Hg||Full Range|Mean
2727572|NCT01036763|Secondary|Physician's Global Evaluation at Visit 2|Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.|after 6 - 12 weeks||||Participants|||Number
2727573|NCT01036763|Secondary|Physician's Global Evaluation at Visit 1|"Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores Poor (1, 2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8) prior to treatment with Spiriva."|0 weeks||||Participants|||Number
2727574|NCT01036763|Primary|Assessment of Tolerability According to Patient|Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks||||Participants|||Number
2727575|NCT01036763|Primary|Assessment of Efficacy According to Patient|patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks||||Participants|||Number
2727576|NCT01036763|Primary|Assessment of Tolerability According to Physician|Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks||||Participants|||Number
2727577|NCT01036763|Primary|Assessment of Efficacy According to Physician|Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks||||Participants|||Number
2727578|NCT01036763|Primary|Success of Treatment With Tiotropium According to Physician's Assessment|Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful|6 - 12 weeks|All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics|||Participants|||Number
2727579|NCT01036724|Secondary|Total Procedure Time||Total Duration of the Procedure||||minutes||Full Range|Median
2727580|NCT01036724|Primary|Total Fluoroscopy Time|The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.|Throughout the Total Duration of the Procedure||||minutes||Full Range|Median
2727591|NCT01036321|Secondary|Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||nmol/L||Full Range|Median
2727592|NCT01036321|Secondary|Biomarkers of Disease Progression - IGF-1|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||ng/mL||Full Range|Median
2727593|NCT01036321|Secondary|Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||mg/L||Full Range|Median
2727594|NCT01036321|Secondary|Biomarkers of Disease Progression - Free Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||pg/ml||Full Range|Median
2727595|NCT01036321|Secondary|Biomarkers of Disease Progression - Estradiol|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||pmo/L||Full Range|Median
2727596|NCT01036321|Secondary|Change in Plasma Concentrations of Isoflavone|Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.|Up to 6 weeks|All participants who were randomized to a study arm.|||mg||Full Range|Median
2727597|NCT01036321|Secondary|Biomarkers of Disease Progression - Serum PSA|Median change from baseline to post intervention: Prostatic specific antigen (PSA). All Participants (ALL); Caucasian Men only (CM only); African American Men only (AAM only).|Up to 6 weeks|All participants who were randomized to a study arm.|||ng/mL||Full Range|Median
2727598|NCT01036321|Primary|Number of Toxicity Events by Final Attribution and Treatment Arm|Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.|Up to 6 weeks|All participants who were randomized to a study arm.|||Toxicity Events|||Number
2727599|NCT01036321|Primary|Median Change in Percent Ki-67 From Baseline|Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.|Baseline to post intervention - up to 6 weeks|All participants who were randomized to a study arm.|||percentage of tumor cells||Full Range|Median
2727600|NCT01036165|Secondary|Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.|The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at Week 12||||Percentage of subjects||95% Confidence Interval|Mean
2727601|NCT01036165|Primary|The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire.|Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 Weeks||||Proportion of subjects||95% Confidence Interval|Mean
2727602|NCT01036022|Secondary|Volume of Distribution Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data|Volume of distribution derived from concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.|Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population.||||||
2727603|NCT01036022|Secondary|Plasma Clearance Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data|Clearance derived from plasma concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.|Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population.||||||
2727604|NCT01036022|Secondary|Pre-dose Trough Concentration at the End of the Dosing Interval (Cτ) on Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing|Cτ was derived on Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).|Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population. Data is presented for the participants available at the time of assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2727605|NCT01036022|Secondary|Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing|Cmax was derived on Day 1 and Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).|Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
2727660|NCT01035658|Secondary|To Determine the Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin.||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.||||||
2732837|NCT00998049|Secondary|CD34 Yield Day 2|Number of CD34 cells/kg collected on day 2|Day 2||||cells/kg||Full Range|Median
2727606|NCT01036022|Secondary|Mean Fecal Lactoferrin Levels Over Time|Fecal lactoferrin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Lactoferrin is an iron binding glycoprotein that is the major component of the secondary granules of polymorphonuclear neutrophils (but not monocytes and lymphocytes). Lactoferrin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Lactoferrin plays an important role in the innate immunity as a bactericidal and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2727607|NCT01036022|Secondary|Mean Fecal Calprotectin Levels Over Time|Fecal calprotectin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Calprotectin is a calcium and zinc-binding protein found in neutrophils, monocytes and macrophages. Calprotectin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Calprotectin plays a regulatory role in the inflammatory process and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||μg/g||Geometric Coefficient of Variation|Geometric Mean
2727608|NCT01036022|Secondary|Median Time to Clinical Response and Clinical Remission|Time to clinical response was defined as the number of days between first dose of study medication and first day of at least 3 consecutive days with SCCAI score decreased for >2 points in comparison with baseline (Day -1 value). Time to clinical remission was defined as the number of days between the first dose of study medication and the first day of at least 3 consecutive days with SCCAI score < 3. Time to clinical response and remission was derived using daily diary data. Participants who did not meet the criteria for clinical response or clinical remission were censored at their last day on study medication.|Up to Week 6|ITT Population. Data is presented for the participants available at the time of assessment. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||Days||Full Range|Median
2727609|NCT01036022|Secondary|Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6|Participants were defined as clinical responders if the average change from baseline total SCCAI score was <-2. (i.e. the post dose total SCCAI score was decreased by >2 points compared to the baseline total SCCAI score). Baseline was defined as the value on Day -1. The change from baseline total SCCAI score was derived by subtracting the baseline value (Day -1) from the individual post-dose values. Participants were defined as in clinical remission if the post dose total SCCAI score was <3 and baseline SCCAI score was not <3 (i.e . =>3).|Week 4 and Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||Participants|||Number
2727610|NCT01036022|Secondary|Mean Simple Clinical Colitis Activity Index (SCCAI) Score|SSCAI included composite score: bowel frequency during day on a scale of 0-3 defined as 0 was <= 3, 1= 4 to 6, 2= 7 to 9 and 3 was > 9, during night on a scale of 0-2 defined as 0= none, 1=1 to 3 and 2 was >=4, defecation urgency on a scale of 0-3 defined as 0=none, 1=hurry, 2=immediately and 3=incontinence, blood in stool on a scale of 0-3 defined as 0= none, 1= trace, 2= occasionally frank and 3= usually frank, general well being on a scale of 0-4 defined as 0=very well, 1= slightly below par, 2= poor, 3 = very poor and 4= terrible, extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis) on a scale of 0-1 defined as 0= absent, 1= present. The SCCAI score was calculated as a sum of scores for each individual component of the SCCAI. Minimum score 0, maximum score 19. Higher score implied worsening of symptoms. Participants were given a diary to score each component of SCCAI each morning. Average SCCAI scores over last 3 days were used for each Week.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the electronic case report form (eCRF) without any imputations added.|||Score on scale||Standard Error|Least Squares Mean
2727611|NCT01036022|Primary|Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose|The assessment was done on the samples collected from the sigmoid colon and from the rectum obtained within 24 hour after the last dose on Week 4 visit after endoscopic evaluation of respective area for determination of GSK1399686 concentration. Non-quantifiable (NQ) concentration values were imputed as 0.|Week 4|Pharmacokinetic (PK) Population which was defined as the participants in the ITT Population for whom a PK sample was obtained and analysed. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)/mL||Standard Deviation|Mean
2727612|NCT01036022|Primary|Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline|Treatment effects was assessed using a low-dose ACTH stimulation test which was performed on Day 1 pre dose (Baseline) and at Week 4 visit. A blood sample for plasma cortisol was taken immediately, before and 30 minutes after an intravenous injection of 1 microgram (μg). tetracosactide acetate, a synthetic peptide displaying the same physiological properties as ACTH. The change from morning basal cortisol was calculated for Day 1 pre-dose (ACTH1) and Week 4 (ACTH2) using the equation: ACTH1 = Day 1 post ACTH - Day 1 pre ACTH; ACTH2 = Week 4 post ACTH - Week 4 pre ACTH. The change from morning basal cortisol between Week 4 and Day 1 (ACTH effect) was calculated as : ACTH effect = ACTH2 - ACTH1. The difference in morning basal cortisol between Week 4 and Day 1 (ACTH morning) was calculated as:- ACTH morning = Week 4 pre ACTH - Day 1 pre ACTH. Adrenocorticol function was classed as normal if the change from post ACTH to pre ACTH (using ACTH1 and ACTH2) was >= 200 nanomoles per liter.|Baseline (Day 1, pre dose) and Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Nanomoles per liter||Standard Error|Least Squares Mean
2727661|NCT01035658|Primary|Phase II: Progression Free Survival|Defined as from date of randomization until objective tumor progression or death.|18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.||||||
2728632|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|before and 3 weeks after surgery|ITT|||Participants|||Number
2727613|NCT01036022|Primary|Number of Participants With Abnormal Electrocardiography (ECG) Findings|Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, and QTc intervals. Criteria for ECG parameter values meeting PCI included absolute QTc interval >500 millisecond (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Only those participants for whom at least one value of abnormal clinically significant or abnormal not clinically significant ECG findings were reported at any visit are summarized.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2727614|NCT01036022|Primary|Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI)|Vital signs assessment included systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate (HR). Criteria for vital sign values meeting PCI included: SBP < 85 and > 160 millimeter of mercury (mmHg); DBP < 45 and > 100 mmHg and HR < 40 and > 110 beats per minute (bpm). The assessments were done on screening, Week 2, Week 4 and Week 6. The participants with values higher and lower than the PCI range is presented. Only those parameters for which at least one value of PCI was reported at any visit are summarized.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2727615|NCT01036022|Primary|Number of Participants of Abnormal Urinalysis Dipstick Results|The urinalysis parameters included urine occult blood, urine general, glucose, ketones and protein by dipstick analysis. The assessments were done on screening, Week 2, Week 4 and Week 6.The number of participants with results of 0, 0.3, 1, 1+, 1.5, 10, 2+, 3+, 30, 4+, 5+, 55, not rated (NR), positive (pos) and trace is presented.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2727616|NCT01036022|Primary|Number of Participants With Hematology Data Outside the Reference Range|Normal reference range for clinical chemistry parameters include: basophils 0 - 0.2 giga cells (GI)/L; eosinophils 0 - 0.4 GI/L; lymphocytes 1 - 4.8 GI/L; monocyte 0 - 0.8 GI/L; total neutrophils (total absolute neutrophils count) 1.8 - 7.7 GI/L; platelet count 150 - 400 GI/L; red blood cell count 4.5 - 5.9 GI/L; white blood cell count 3.9 - 10.6 GI/L; hemoglobin 135 - 175 g/L; hematocrit 0.41 - 0.53 ratio; mean corpuscle hemoglobin concentration 310 - 370 g/L; mean corpuscle hemoglobin 26 - 34 picogram (PG); mean corpuscle volume 80 - 100 femtoliter (FL); reticulocytes 0.05 - 0.1 trillion cells (TI)/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.|Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2727617|NCT01036022|Primary|Number of Participants With Clinical Chemistry Data Outside the Reference Range|Normal reference range for clinical chemistry parameters include: alanine amino transferase (ALT) 0-41 international units per liter (IU/L); aspartate amino transferase (AST) 10 - 38 IU/L; alkaline phosphatase 40 - 129 IU/L; gamma glutamyl transferase (GGT) 10 - 66 IU/L; albumin 39 - 48 gram per liter (g/L); total protein 66 - 87 g/L; direct bilirubin 0 - 5.13 micromole per liter (µmol/L); total bilirubin 0 - 17.1 µmol/L; creatinine 61.88 - 106.08 µmol/L; uric acid 202.232 - 416.36 µmol/L; calcium 2.0958 - 2.42015 millimole per liter (mmol/L); cholesterol 2.8446 - 5.9478 mmol/L; chloride 98 - 106 mmol/L; glucose 2.2204 - 11.102 mmol/L; potassium 3.4 - 4.5 mmol/L; magnesium 0.6576 - 1.0686 mmol/L; sodium 0 - 2.26 mmol/L; urea/ blood urea nitrogen (BUN) 0 - 17.85 mmol/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.|Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2727618|NCT01036022|Primary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Week 6|Intent-To-Treat (ITT) Population was defined as all participants who were randomized to treatment, who received at least one dose of study medication and who had at least one valid post dose assessment.|||Participants|||Number
2727619|NCT01036009|Post-Hoc|Time Until Late Relapse|Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as >5% blasts in bone marrow|24-36 months post-transplant|intervention patients who relapsed after the 2 year primary study endpoint|||months||Full Range|Mean
2727620|NCT01036009|Post-Hoc|Late Relapses|The number of patients who relapsed after 2-year primary endpoint. To assess a potential for late relapse-rate in the intervention arm only, patients in the intervention arm were provided additional follow-up until 3-yrs post transplant. The criterion for relapse was >5% blasts in bone marrow.|24-36 months post-transplant|surviving patients in the intervention arm who had not relapsed as of 24 months were followed for an additional 12 months (until 3 years post-transplant)|||participants|||Number
2727621|NCT01036009|Secondary|The Incidence of Chronic GVHD (cGVHD).|"Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955.~The diagnosis of chronic GVHD requires the following:~1) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses.~Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores."|2 years post transplant||||participants|||Number
2727622|NCT01036009|Secondary|The Incidence of Acute Graft Versus Host Disease (aGVHD).|"Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8.~In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea."|2 years post transplant||||participants|||Number
2727623|NCT01036009|Secondary|2 Years Post-transplant Survival.||2 years post transplant||||participants|||Number
2727624|NCT01036009|Primary|Relapse at 2 Years Post-transplant.|Definition of relapse was >5 % blasts in bone marrow|2 years post transplant.||||participants|||Number
2727625|NCT01035944|Secondary|Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.||2 days and 5 days after debridement.|||||||
2727626|NCT01035944|Primary|Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.||2 days and 5 days after debridement.|Zero participant data were analyzed. Study was terminated early; unable to reach enrollment milestones.||||||
2727627|NCT01035905|Primary|Lens Awareness|Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.|4 weeks of wear|Per Protocol|||Participants|||Number
2727628|NCT01035788|Primary|Clinician-Administered PTSD Scale (CAPS)|The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.|treatment end (approximately 10 weeks after session 1 of the interventions)|This analysis was intention to treat and included the 30 participants of the original 34 who completed the CAPS interview at treatment end.|||units on a scale||95% Confidence Interval|Least Squares Mean
2727629|NCT01035749|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 364)|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2727630|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 21-day (Days 0-20) follow-up period after booster vaccination.|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study."|||Subjects|||Number
2727631|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 42-day (Days 0-41) follow up period after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2727632|NCT01035749|Secondary|Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges|Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).|At Days 0, 21, 42, 182 and 189|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189."|||Subjects|||Number
2727633|NCT01035749|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-364) following first vaccination|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2727634|NCT01035749|Secondary|Number of Subjects Reporting Any Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (Days 0-364) following the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2727635|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following booster dose|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study."|||Subjects|||Number
2732838|NCT00998049|Secondary|CD34 Yield on Day 1|Number of CD34 cells/kg collected on day 1.|Day 1||||cells/kg||Full Range|Median
2727636|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2727637|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity|During the 7-day (Days 0-6) post-vaccination period following booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2727638|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2727639|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Fold increase||95% Confidence Interval|Geometric Mean
2727640|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Fold increase||95% Confidence Interval|Geometric Mean
2727641|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Fold increase||95% Confidence Interval|Geometric Mean
2727642|NCT01035749|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2727643|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, Day 182 and Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Subjects|||Number
2727644|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Subjects|||Number
2727645|NCT01035749|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available|||Subjects|||Number
2727646|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Subjects|||Number
2727647|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Subjects|||Number
2727648|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Subjects|||Number
2727649|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titers were expressed as GMTs.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.|||Titers||95% Confidence Interval|Mean
2727650|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available|||Subjects|||Number
2727651|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Days 0, 182 and 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Titers||95% Confidence Interval|Geometric Mean
2727652|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as GMTs.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
2727653|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.|||Titers||95% Confidence Interval|Geometric Mean
2727654|NCT01035749|Primary|HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2727655|NCT01035749|Primary|Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.|||Subjects|||Number
2727656|NCT01035749|Primary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.|||Subjects|||Number
2727657|NCT01035658|Primary|Phase I - Dose Limiting Toxicites|As requested, this outcome measure reports the number of patients experiencing dose limiting toxicites (DLTs) in the Phase I portion of the study|18 months||||participants|||Number
2727658|NCT01035658|Secondary|To Evaluate the Toxicity of the Combination of Pazopanib and Liposomal Doxorubicin||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.||||||
2727659|NCT01035658|Secondary|To Determine the Efficacy of Pazopanib/Liposomal Doxorubicin (Response Rate, Progression-free Survival, Overall Survival) Separately in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma||18 months|||||||
2731948|NCT01004354|Secondary|Total Cholesterol at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
2727662|NCT01035658|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin|The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months||||mg|||Number
2727663|NCT01035606|Secondary|Change to Attention and Executive Functioning Composite Scores|"Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3.~Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning.~The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time."|5 weeks (After completion of Arm 1 and Arm 2)||||Aggregate Z-scores||Standard Deviation|Mean
2727664|NCT01035606|Secondary|Change From Baseline to Post-training for Task Errors on a Functional Performance Measure|Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).|5 weeks (After completion of Arm 1 and Arm 2)||||Number of task failures||Standard Deviation|Mean
2727665|NCT01035606|Primary|Self-report|Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.|5 Weeks (After completion of active trainings in Arm 1 and Arm 3)||||units on a scale||Standard Deviation|Mean
2727666|NCT01035463|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate the overall survival distribution. This outcome only reports data as it pertains to overall survival at one year. All-cause mortality includes survival for follow up for all subjects on the study.|1 year||||percentage of participants||95% Confidence Interval|Number
2727667|NCT01035463|Secondary|Event-free Survival|The Kaplan-Meier method will be used to estimate the event-free survival distribution.|1 year||||percentage of participants||95% Confidence Interval|Number
2727668|NCT01035463|Primary|Maximum Tolerated Dose of Lenalidomide (Phase I)|The Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 3 out of 6 subjects experience dose limiting toxicities during cycle 1. Dose limiting toxicities graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Cycle 1, 28 days||||milligrams PO daily|||Number
2727669|NCT01035346|Secondary|Rating of Study Medication Relative to Usual Medication|Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||units on a scale||Standard Deviation|Mean
2727670|NCT01035346|Secondary|Global Assessment of Study Medication as an Antipyretic|Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||units on a scale||Standard Deviation|Mean
2727671|NCT01035346|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||percentage of participants|||Number
2727672|NCT01035346|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||hours||95% Confidence Interval|Median
2727673|NCT01035346|Secondary|Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8|Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||Degrees Fahrenheit||Standard Deviation|Mean
2727674|NCT01035346|Secondary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)|STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 4, 0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||Degrees Fahrenheit||Standard Deviation|Mean
2727705|NCT01035138|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12|The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||cubic millimeter (mm³)||Standard Error|Least Squares Mean
2727675|NCT01035346|Primary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)|STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment.|||Degrees Fahrenheit||Standard Deviation|Mean
2727676|NCT01035333|Secondary|Patient Satisfaction||6 months|Patients who completed 6 months of the study.|||participants|||Number
2727677|NCT01035333|Primary|Weight Loss|Weight loss acheived during time on study up to 6 months.|6 months|All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.|||percentage of weight||Standard Deviation|Mean
2727678|NCT01035255|Secondary|Percentage of Participants With New Onset of Atrial Fibrillation (AF)|Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).|up to 51 months|The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).|||Percentage of participants|||Number
2727679|NCT01035255|Secondary|Number of Patients With First Confirmed Renal Dysfunction|Number of patients with first confirmed renal dysfunction|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations|||participants|||Number
2727680|NCT01035255|Secondary|Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 8|FAS included all randomized patients with two exclusions: 6 pts who did not qualify for randomization but were misrandomized into the study and did not receive study meds; 37 pts because they were randomized at sites that were closed due to serious GCP violations The analysis included all FAS patients with at least one KCCQ data up-to Month 8.|||KCCQ Score||Standard Error|Least Squares Mean
2727681|NCT01035255|Secondary|Number of Patients Reported With Adjudicated Primary Causes of Death|Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014|up to 51 months|Randomized set (RAN): Consisted of all patients who received a randomization number, regardless of receiving trial medication.|||participants|||Number
2727682|NCT01035255|Secondary|Number of Patients - All-cause Mortality|Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations|||participants|||Number
2727683|NCT01035255|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations|||participants|||Number
2727684|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmax|Cmax is the maximum (peak) blood drug concentration after dose administration (ng/mL) calculated as the maximum of C1h and C2h. C1h was 1 hour post-dose blood concentration (ng/mL) and C2h was 2 hour post-dose blood concentration (ng/mL). C1h and C2h post-dose samples were collected from all patients in both arms at Visit 3. Steady-state for the C1h and C2h samples was defined as continuous administration of the same dose in the previous 4 days and the day on which the C1h and C2h samples were collected. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid C1h and C2h everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|Safety Set consists of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.|||ng/mL||Standard Deviation|Mean
2727685|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmin|Cmin is the pre-dose blood concentration at steady-state (ng/mL). Pre-dose (Cmin) blood samples were collected from all patients in both arms at Visit 3. Steady-state for the Cmin sample was defined as continuous administration of the same dose in the last 4 days prior to the collection of the Cmin sample. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid pre-dose (Cmin) everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|Safety Set consisted of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.|||ng/mL||Standard Deviation|Mean
2727686|NCT01035229|Secondary|Time to Definitive Deterioration of EORTC QLQ-C30 Scores|The primary quality of life endpoint was the time to definitive 5% deterioration from baseline in the global health status/quality of life scale of the EORTC QLQ-C30 questionnaire. Definitive deterioration by at least 5% is defined as a decrease in score by at least 5% compared to baseline, with no later observed increase above this threshold. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
2727687|NCT01035229|Secondary|Time to Definitive Deterioration of ECOG Performance Score (PS) Score|Change in Eastern Cooperative Oncology Group (ECOG) were assessed by time to definitive performance status deterioration by at least one category on the ECOG scale. Deterioration was considered definitive if no improvement in the ECOG PS was observed at a subsequent measurement. ECOG PS: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5=Dead|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
2727688|NCT01035229|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR is defined as the proportion of participants with a best objective response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST. The BOR was the best response recorded from the start of the treatment until disease progression. CR is disappearance of all target lesions; PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is at least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.|||Percentage of Participants|||Number
2727689|NCT01035229|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of randomization to the date of the first documented radiologic confirmation of disease progression. Since the study did not meet the primary objective, TTP was not formally tested.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
2727690|NCT01035229|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. The comparison of OS between the 2 arms was done using a stratified log-rank test at one-sided 2.5% level of significance.|When 454 OS events were observed|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
2727691|NCT01035151|Primary|Number of Participants Abstinent From Smoking|Reported abstinence validated by exhaled CO and saliva cotinine|12 month||||Participants|||Count of Participants
2727692|NCT01035138|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12|RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||number of hospitalizations||Standard Deviation|Mean
2727693|NCT01035138|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) at Week 24|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727694|NCT01035138|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24|The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727706|NCT01035138|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||percentage of change||Standard Error|Least Squares Mean
2727695|NCT01035138|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24|The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727696|NCT01035138|Secondary|Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24|The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727697|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
2727698|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
2727699|NCT01035138|Secondary|Mean Concentration of LY450139||3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)|Participants who completed Study LFAN, took study drug in extension study and had pharmacokinetics measurements.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2727700|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727701|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727702|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727703|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2727704|NCT01035138|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Due to insufficient sample size, this analysis was not done.||||||
2727909|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 16|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 16|Not all participants answered every question|||percentage of partcipants|||Number
2727707|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
2727708|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
2727709|NCT01035073|Secondary|Functional Symptom Questionnaire||Baseline; Week 6 and Week 8 of Treatment|The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator’s behalf, data are not available.||||||
2727710|NCT01035073|Primary|24-hour Activity Level||Baseline and Week One of Treatment|The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator’s behalf, data are not available.||||||
2727711|NCT01035060|Primary|Muscle Satellite Cells|Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.|Baseline, 2 days post-injury, 7 days post-injury||||Number of Pax7+ cells/muscle fiber||Standard Error|Mean
2727712|NCT01035047|Secondary|Stress Testing-related Adverse Event||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis|||participants|||Number
2727713|NCT01035047|Secondary|Mortality||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis.|||participants|||Number
2727714|NCT01035047|Secondary|Acute Coronary Syndrome||Index Hospitalization discharge through 90 days|Data from all participants was used in outcome analysis.|||participants|||Number
2727715|NCT01035047|Secondary|Length of Stay||Duration of Index Hospitalization, an average of 1-2 days|Data from all participants was used in outcome analysis.|||hours||Full Range|Median
2727716|NCT01035047|Primary|The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.||Index Hospitalization through 90 days|Data from all participants was used in the primary outcome analysis.|||participants|||Number
2727717|NCT01034709|Primary|a) CMV Viral Load|The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined.|3 months||||percentage of agreement|||Number
2727718|NCT01034657|Secondary|Time to Cause-specific Death - Overall Period|Time to cause-specific death was defined as the time from start of treatment to death related to MDS.|52 weeks|Time to cause-specific death could not be evaluated because there was no cause-specific death.||||||
2727719|NCT01034657|Secondary|Disease-free Survival (DFS) - Overall Period|DFS was defined as the time from start of treatment to the time to relapse.|52 weeks|DFS could not be evaluated because there was no disease-free period.||||||
2727720|NCT01034657|Secondary|Progression-free Survival (PFS) - Overall Period|PFS was defined as the time from start of treatment to disease progression or death from MDS.|52 weeks|PFS could not be evaluated because there was no progression.||||||
2727721|NCT01034657|Secondary|Event-free Survival (EFS) - Overall Period|EFS was defined as the time from start of treatment to failure or death from any cause.|52 weeks|Event-free survival could not be evaluated because there was no response, no progression or no disease-free period.||||||
2727722|NCT01034657|Secondary|Time to Response - Overall Period|Time to response was defined as the time from start of treatment to the first documented response (complete [CR] or partial [PR]) according to modified IWG criteria for HI.|52 weeks|Time to response could not be evaluated because there was no response.||||||
2727723|NCT01034657|Secondary|Overall Survival (OS) - Overall Period|OS was defined as the time from start of treatment to death from any cause.|48 weeks|All participants from the core phase were analyzed.|||months||90% Confidence Interval|Median
2727724|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Participants from the randomized phase, who had values at week 52, were included in the analysis.|||units on a scale||Standard Deviation|Mean
2727732|NCT01034631|Secondary|Exploratory Objective: Correlation of PFS With Biomarkers|Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.|6 months|Analysis was pre-specified to look at the correlation irrespective of arm.|||Correlation with PFS P Value|||Number
2727733|NCT01034631|Secondary|Phase II: Overall Survival|Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.|60 months||||probability of OS at 60 months.|||Number
2727725|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.|||units on a scale||Standard Deviation|Mean
2727726|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Only participants from the randomized phase, who had values at week 52, were included in the analysis.|||Percentage of participants|||Number
2727727|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.|||Percentage of participants|||Number
2727728|NCT01034657|Secondary|Percentage of Participants With Objective Response During the Randomized Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|32 weeks, 48 weeks|Participants from the randomized phase, who had valid data, were analyzed.|||Percentage of participants|||Number
2727729|NCT01034657|Secondary|Percentage of Participants With Objective Response During Core Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|16 weeks|Participants from the core phase, who had valid data, were analyzed.|||Percentage of participants|||Number
2727730|NCT01034657|Secondary|Percentage of Participants With HI-E - Randomized Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|32 weeks, 52 weeks|Participants from the randomized phase, who had valid response data, were analyzed.|||Percentage of participants|||Number
2727731|NCT01034657|Primary|Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|16 weeks|Participants from the core phase, who had valid response data, were analyzed.|||Percentage of participants|||Number
2727734|NCT01034631|Secondary|Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.|Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.|12 months||||number of adverse events|||Number
2727735|NCT01034631|Secondary|Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.|Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|12 months||||months||95% Confidence Interval|Median
2727736|NCT01034631|Secondary|Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone|Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|12 months||||Participants|||Count of Participants
2727737|NCT01034631|Secondary|Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.|Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P|12 months|14 participants has sufficient data collected for the analysis of this objective|||hours||Full Range|Geometric Mean
2727738|NCT01034631|Secondary|Phase I: Response Rate of BNC105P in Combination With Everolimus.|Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months||||Participants|||Count of Participants
2727739|NCT01034631|Primary|Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.|Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|6 months||||probability of 6MPFS|||Number
2727740|NCT01034631|Primary|Phase I: Toxicities of BNC105P in Combination With Everolimus.|Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|12 participants who completed at least one cycle of combination therapy.|||participants|||Number
2727741|NCT01034631|Primary|Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.|Phase I|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|12 participants completed at least one cycle of combination therapy and were evaluable.|||mg/m^2|||Number
2727742|NCT01034592|Secondary|Toxicity|Toxicity was assessed as the number of adverse events related to lenalidomide.|6 months|Both participants were assessed and contributed to the analysis.|||Related Adverse Events|||Number
2727743|NCT01034592|Secondary|Duration of Response|The response duration was measured from the last of the consecutive 56 days during which the subject was free of red blood cells (RBC) transfusions to the date of the first RBC transfusion after the 56-day RBC-transfusion-free period.|6 months|Both participants were assessed and contributed to the analysis, but never demonstrated any therapeutic response.|||days||Full Range|Median
2727744|NCT01034592|Secondary|Platelet Response|The effect on platelet levels as assessed as the change in platelet count from baseline.|6 months|Both participants were assessed and contributed to the analysis.|||1000/uL||Full Range|Median
2727745|NCT01034592|Secondary|Neutrophil Response|The effect on neutrophil levels was assessed as the change in neutrophil count from baseline.|6 months|Both participants were assessed and contributed to the analysis.|||1000/uL||Full Range|Median
2727746|NCT01034592|Secondary|Hemoglobin Concentration|The effect on hemoglobin concentration was assessed as the change from baseline, measured in g/dL.|6 months|Both participants were assessed and contributed to the analysis.|||g/dL||Full Range|Median
2727747|NCT01034592|Secondary|Red Blood Cell (RBC) Transfusions|The effect on red blood cell (RBC) transfusions was assessed as the number of participants that achieved a greater than 50% decrease in RBC transfusion requirements.|6 months|Both participants were assessed and contributed to the analysis.|||Participants|||Count of Participants
2727748|NCT01034592|Primary|Red Blood Cell (RBC) Transfusion Independence|"Red blood cell (RBC) transfusion independence is reported as the number of subjects who achieve a continuous absence of the intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period."|6 months|All treated subjects were analyzed.|||participants|||Number
2727749|NCT01034579|Secondary|Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker|Mean number of T2 active lesions was measured by using MRI scans. SNP5 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Mean number of T2 active lesions segregated on the basis of SNP5 marker variables were reported.|Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||T2 lesions||Standard Deviation|Mean
2727826|NCT01034163|Primary|Number of Participants With Adverse Events|Safety monitoring was conducted throughout the study.|23 months|Safety set: The safety set included randomized participants who received at least one dose of study treatment.|||Participants|||Number
2727750|NCT01034579|Secondary|Change in Brain Volume as Defined by SNP2 Marker|Change in brain volume was measured as the brain parenchymal fraction using MRI scans. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Change in brain volume segregated on the basis of SNP2 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||cubic millimeter (mm^3)||Standard Deviation|Mean
2727751|NCT01034579|Secondary|Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers|Change in T1 Gd enhancing lesion volume was measured by using magnetic resonance imaging (MRI) scans. SNP4 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). SNP3 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Change in T1 Gd enhancing lesion volume segregated on the basis of SNP3 and SNP4 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||cubic millimeter (mm^3)||Standard Deviation|Mean
2727752|NCT01034579|Secondary|Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Number of responders segregated on the basis of SNP2 marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||participants|||Number
2727753|NCT01034579|Primary|Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers|A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338). All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6. Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables. For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), the absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). For the three-level allele-based association SNP markers (SNP1, SNP3, and SNP5), the analysis was based on the number of copies of the allele (0, 1 and 2). Percentage of responders segregated on the basis of SNP marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||percentage of participants|||Number
2727754|NCT01034553|Secondary|Overall Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.|||Months||95% Confidence Interval|Median
2727755|NCT01034553|Secondary|Progression-free Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.|||Months||95% Confidence Interval|Median
2727756|NCT01034553|Primary|Overall Response Rate to the Combination of MLN8237 and Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma.|sCR: Normal serum FLC ratio, and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, negative immunofixation of the serum and urine, <5% plasma cells in bone marrow, disappearance of any soft tissue plasmacytomas, and normalization of FLC ratio. VGPR:PR and serum and urine M-component detectable by immunofixation but not on electrophoresis, or if serum measurable,≥90% or greater reduction in serum M-component plus urine M-component <100 mg per 24h and if only measurable non-bone marrow parameter was FLC,≥90% or greater reduction in difference from involved and uninvolved FLC levels. PR:≥50% reduction of serum M-protein or reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24h or if FLC, ≥50% decrease in the difference between involved and uninvolved FLC levels or ≥50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥30%, and ≥50% reduction in the size of soft tissue plasmacytomas|Every 28 day cycle(up to 10 cycles)|All patients that received treatment were evaluated.|||percentage of patients per dose level|||Number
2727757|NCT01034553|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows:~An AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria:~Grade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity~The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose."|28 days||||participants|||Number
2727758|NCT01034540|Secondary|Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.|"Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose.~Disposition index = MISI x insulin secretion index"|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population excluding subjects with poor compliance and protocol violations.|||Index value||Standard Error|Mean
2727983|NCT01033825|Secondary|Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.|Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).|Weeks 1-2, 2-4|Intent to Treat Population|||percentage of correct advances||Standard Deviation|Mean
2727759|NCT01034540|Primary|Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).|Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population in which subjects with poor compliance, protocol violations, and without at least one post-randomization outcome data point during each treatment intervention period were removed.|||Index value||Inter-Quartile Range|Median
2727760|NCT01034527|Primary|Decrease in Knee Valgus Measurement|determine biomechanical risk factors for ACL injury and determine if participation in NMT reduces risk factors compared to sham (speed training)|2 years||||Participants|||Count of Participants
2727761|NCT01034462|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|"The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product.~The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score."|||units on a scale||Standard Error|Least Squares Mean
2727762|NCT01034462|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2727763|NCT01034397|Secondary|Change From Baseline to Week 24 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
2727764|NCT01034397|Secondary|Change From Baseline to Week 12 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
2727765|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum DHEA|Change in DHEA was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
2727766|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Dehydroepiandrosterone (DHEA)|Change in DHEA was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
2727767|NCT01034397|Secondary|Change From Baseline to Week 24 in 17OHP|Change in 17OHP was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
2727768|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
2727769|NCT01034397|Secondary|Change From Baseline to Week 12 in 17 Hydroxy Progesterone (17OHP)|Change in 17OHP was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
2727770|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
2727771|NCT01034397|Secondary|Change From Baseline to Week 24 in Plasma ACTH|Change in plasma ACTH was determined as the difference in the scores at baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
2727772|NCT01034397|Secondary|Change From Baseline to Week 12 in Plasma Adrenocorticotrophic Hormone (ACTH)|Change in Plasma ACTH was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
2727773|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population;|||mg/dL||Full Range|Median
2727774|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
2727775|NCT01034397|Secondary|Change From Baseline to Week 24 in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Week 24|ITT population|||mg/dL||Full Range|Median
2727776|NCT01034397|Secondary|Change From Baseline to Week 12 in C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was measured in milligrams per deciliter (mg/dL).|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mg/dL||Full Range|Median
2727777|NCT01034397|Secondary|Change From Baseline to Week 24 in ESR|ESR is an inflammatory marker and is used to assess disease activity in RA. A reduction in ESR indicates improvement.|Week 24|ITT population|||mm/hr||Full Range|Median
2727778|NCT01034397|Secondary|Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammatory marker and is used to assess disease activity in rheumatoid arthritis (RA). A reduction in ESR indicates improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mm/hr||Full Range|Median
2728633|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 12 months after drug administration|ITT|||Participants|||Number
2727779|NCT01034397|Secondary|Health Assessment Questionnaire - Disease Index (HAQ-DI) Scores|The HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727780|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population|||mm||Full Range|Median
2727781|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mm||Full Range|Median
2727782|NCT01034397|Secondary|Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specific parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mm||Full Range|Median
2727783|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Disease Activity|"General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: In general how would you rate your health over the last 2-3 weeks?. Participants responded by marking the line and the distance from the left edge was recorded."|Week 24|ITT population|||mm||Full Range|Median
2727784|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Disease Activity|"General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: In general how would you rate your health over the last 2-3 weeks?. Participants responded by marking the line and the distance from the left edge was recorded."|Week 12|ITT population|||mm||Full Range|Median
2727785|NCT01034397|Secondary|Change From Baseline to Week 24 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population|||swollen joints||Full Range|Median
2727786|NCT01034397|Secondary|Change From Baseline to Week 12 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population|||swollen joints||Full Range|Median
2727787|NCT01034397|Secondary|Change From Baseline to Week 24 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population|||tender joints||Full Range|Median
2727788|NCT01034397|Secondary|Change From Baseline to Week 12 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population|||tender joints||Full Range|Median
2727789|NCT01034397|Secondary|Tender and Swollen Joint Counts|TJC and SJC were determined using the 28 joint counts. Joints were classified as tender/not tender and swollen/not swollen and counted. The scores ranged from 0 to 28. Higher scores indicated higher disease activity.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||joints||Full Range|Median
2727790|NCT01034397|Secondary|Change From Baseline to Week 24 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population|||units on a scale||Full Range|Median
2727791|NCT01034397|Secondary|Change From Baseline to Week 12 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727792|NCT01034397|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727793|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population|||units on a scale||Full Range|Median
2727794|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population|||percent change||Full Range|Median
2727795|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727796|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
2727797|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;|||units on a scale||Full Range|Median
2727798|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;|||percent change||Full Range|Median
2727799|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2728012|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Error|Least Squares Mean
2727800|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
2727801|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;|||units on a scale||Full Range|Median
2727802|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population|||percent change||Full Range|Median
2727803|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727804|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of initial rate of enhancement (IRE) and number of voxels (Nvox), which are extracted by examining individual signal intensity vs time curves derived from defined regions of interest (ROIs). A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. Maximum enhancement (ME)=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of signal intensity (SI) until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
2727805|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.|||percent change||Full Range|Median
2727806|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.|||percent change||Full Range|Median
2727910|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 12|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 12|Not all participants answered every question|||percentage of participants|||Number
2727807|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727808|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
2727809|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.|||units on a scale||Full Range|Median
2727810|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population|||percent change||Full Range|Median
2727811|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727812|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
2727813|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 24|ITT population.|||units on a scale||Full Range|Median
2727827|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 104|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
2727814|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727815|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.|||units on a scale||Full Range|Median
2727816|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.|||percent change||Full Range|Median
2727817|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
2727818|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
2727819|NCT01034397|Primary|Percent Change From Baseline to Week 12 in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th metacarpophalangeal (MCP) were assessed for synovitis via magnetic resonance imaging (MRI) and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population; n (number) equals (=) number of participants assessed for the specified parameter|||percent change||Full Range|Median
2727820|NCT01034358|Primary|Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])|Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).|One year||||mMU/mL||95% Confidence Interval|Geometric Mean
2727821|NCT01034306|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters||12 weeks|||||||
2727822|NCT01034306|Secondary|Safety: Adverse Event Reporting, Physical Examination, Vital Signs, Clinical Laboratory Testing||12 weeks|||||||
2727823|NCT01034306|Primary|American College of Rheumatology (ACR20)|Primary efficacy was assessed using ACR20 response at Week 12, with all-cause dropouts considered as non-responders, in the ITT population.|12 weeks||||participants|||Number
2727824|NCT01034176|Secondary|Number of Patients With >50% Reduction in BK Virus Copies|Number of patients with >50% reduction in BK viral load at 6 months|Baseline and 6 months|number of patients with >50% reduction in BK viral load at 6 months|||participants|||Number
2727825|NCT01034176|Primary|Percent Change From Baseline in BK Virus Copies at 3 Months|Percent change in BK virus copies/mL from Baseline to 3 months|Baseline and 3 months||||Percent change of BK virus copies||Standard Deviation|Median
2730846|NCT01012167|Secondary|Vital Signs - Weight|Mean weight (kg) by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||kg||Standard Deviation|Mean
2727828|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 52|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 52|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
2727829|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 24|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 24|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
2727830|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 12|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 12|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
2727831|NCT01034137|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Adverse Events Leading to Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), lifethreatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Up to Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment.|||Number of participants|||Number
2727832|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 104|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for 'Cause' domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727833|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 52|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for 'Cause' domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 52|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727841|NCT01034137|Secondary|Mean Change From Baseline in 36-Item Short Form Health Survey of Quality of Life at Weeks 12, 24, 52, and 104|The 36-Item Short Form Health Survey (SF-36) is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Summary (PCS) and Mental Component Summary (MCS) measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2731949|NCT01004354|Secondary|LDL-cholesterol at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
2727834|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 24|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for 'Cause' domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 24|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727835|NCT01034137|Secondary|Mean Change From Baseline in The Revised Illness Perception Questionnaire (IPQ-R) Score of Quality of Life at Week 12|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for 'Cause' domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 12|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727836|NCT01034137|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Score of Quality of Life at Weeks 12, 24, 52, and 104|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participants response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727837|NCT01034137|Secondary|Mean Change From Baseline in Patient General Wellbeing Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their general wellbeing using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as  not active at all  and the right-hand extreme equals 10 as  very active  .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727838|NCT01034137|Secondary|Mean Change From Baseline in Patient Pain Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727839|NCT01034137|Secondary|Mean Change From Baseline in Physician Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Physician global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Physician global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727840|NCT01034137|Secondary|Mean Change From Baseline in Patient Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Patient global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Patient global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727875|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 8|Not all participants answered every question|||participants|||Number
2727842|NCT01034137|Secondary|Mean Change From Baseline in The EuroQol Score of Quality of Life at Weeks 12, 24, 52 and 104|"EuroQol (EQ-5D) is a standard self-completed participant questionnaire that measures health outcome. The EQ-5D questionnaire consists of 2 parts: 1) EQ-5D with five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale as 1 = no problems, 2 = some/moderate problems, 3 = extreme problems. The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, where '1' indicating full health and '0' representing dead. The positive values indicate that during the study the health status improved. 2) EQ-VAS on a scale of 0 to 100, where 0 = worst possible health status and 100 = best possible health status."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727843|NCT01034137|Secondary|Mean Change From Baseline in The Dutch Consensus Health Assessment Questionnaire of Quality of Life at Weeks 12, 24, 52, and 104|The Dutch Consensus Health Assessment Questionnaire (DC-HAQ) disability index is a self-completed participant questionnaire with 8 domains specific for RA. It assesses a participant functional ability, with scores ranging from 0 (without any difficulty) to 3 (unable to do). A change from baseline of -0.22 is considered to be the minimal clinically important difference.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
2727844|NCT01034137|Secondary|Number of Participants With Change in The Therapy Strategy During The Study|Participants who switched treatment strategy from monotherapy (TCZ+ placebo MTX or MTX+ placebo TCZ treatment) to combination therapy (TCZ+MTX treatment) was reported. Also, participants who switched from verum therapy to standard of care was reported in the below table.|From Baseline to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Number of participants|||Number
2727845|NCT01034137|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (participants not responding to the drug as assessed by the physician) was selected by the investigator as a reason for the participant to withdraw from the study.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
2727846|NCT01034137|Secondary|Mean Change From Baseline in Modified Sharp/Van Der Heijde Score at Weeks 52 and 104|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|From Baseline (Week 0) to Weeks 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Standard Deviation|Mean
2727847|NCT01034137|Secondary|Mean Percent Change From Baseline in CRP at Weeks 12, 24, 52, and 104|CRP is a component of ACR. CRP is a marker of inflammation.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2727848|NCT01034137|Secondary|Mean Percent Change From Baseline in Pain Visual Analog Scale at Weeks 12, 24, 52, and 104|Pain VAS is a component of ACR. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2727849|NCT01034137|Secondary|Mean Percent Change From Baseline in The Physician Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Physician health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).An improvement (decrease) in the physician's global assessment based on disease activity parameter relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2727850|NCT01034137|Secondary|Mean Percent Change From Baseline in Patient Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Patient health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). An improvement (decrease) in the patient's global assessment based on disease activity relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment|||Percent change||Standard Deviation|Mean
2727893|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex."|Week 8|Not all participants answered every question|||percentage of participants|||Number
2727851|NCT01034137|Secondary|Mean Percent Change From Baseline in the Tender Joint Count (TJC) at Weeks 12, 24, 52, and 104|The number of tender joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender joints) to 44 (worse possible score; all tender joints).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2727852|NCT01034137|Secondary|Mean Percent Change From Baseline in the Swollen Joint Count (SJC) at Weeks 12, 24, 52, and 104|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2727853|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 90 Response Rate at Weeks 12, 24, 52 and 104|ACR90 response is defined as a >=90% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or erythrocyte sedimentation rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
2727854|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 70 Response Rate at Weeks 12, 24, 52 and 104|ACR70 response is defined as a >=70% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient's Assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
2727855|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 50 Response Rate at Weeks 12, 24, 52 and 104|ACR50 response is defined as a >=50% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient's assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient's Global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
2727856|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 20 Response Rate at Weeks 12, 24, 52 and 104|American College of Rheumatology (ACR) 20 response is defined as a >= 20% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: patient's assessment of pain over the previous 24 hours: using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
2727876|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 4|Not all participants answered every question|||participants|||Number
2729666|NCT01020812|Secondary|To Determine the Overall Survival of TACE and SBRT at 18 Months|Overall survival is defined as the time from the start of treatment until death from any cause.|18 months|All patients who completed treatment|||probability|||Number
2727857|NCT01034137|Secondary|Median Time to First European League Against Rheumatism Response|It is the time to first EULAR response. EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant's DAS28 as the measure of severity of disease.Good or moderate response is defined as follows: Good response : DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2. Response 1 is defined as yes (good) versus no (moderate or no response). Response 2 is defined as yes (good or moderate) versus no (no response).|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Days||Inter-Quartile Range|Median
2727858|NCT01034137|Secondary|Number of Participants With Good European League Against Rheumatism Response Rate at Weeks 24, 52, and 104|European league against rheumatism (EULAR) response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant's DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response : DAS28 at the time point =<3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and =<1.2.|Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
2727859|NCT01034137|Secondary|Median Change From Baseline in Simplified Disease Activity Index Scores at Weeks 24, 52, and 104|The simplified disease activity index (SDAI ) are continuous measures of RA disease activity.The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm VAS), and C-Reactive Protein (CRP) (mg/dL). SDAI total score ranges from 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Full Range|Median
2727860|NCT01034137|Secondary|Median Change From Baseline in Clinical Disease Activity Index Score at Weeks 24, 52, and 104|The clinical disease activity index (CDAI) are continuous measures of RA disease activity. The CDAI is the numerical sum of four outcome parameters: tender joint count (TJC), swollen joint count (SJC) based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS). CDAI total score ranges from 0 to 76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Full Range|Median
2727861|NCT01034137|Secondary|Absolute Change From Baseline in Disease Activity Score 28 at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the participant's disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Full Range|Median
2727862|NCT01034137|Secondary|Mean Duration of First Disease Activity Score 28 Remission|It is the duration of the first period of DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Weeks||Standard Deviation|Mean
2727863|NCT01034137|Secondary|Percentage of Participants With Cumulative Remission Rate at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the subject's disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2727864|NCT01034137|Secondary|Median Time to First Disease Activity Score 28 Remission|It is the time to event analysis for the first DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Days||95% Confidence Interval|Median
2727877|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study."|Week 24|Not all participants answered every question|||percentage of participants|||Number
2730160|NCT01017029|Secondary|Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group|LDL = low density lipoprotein|6 months|safety population|||participants||95% Confidence Interval|Number
2727865|NCT01034137|Secondary|Number of Participants Achieving Disease Activity Score 28 Remission at Weeks 12, 24, 52, and 104|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
2727866|NCT01034137|Secondary|Mean Duration of First Sustained Remission|It is the duration of the first period of sustained DAS28 remission. Participants who switch treatment strategy before reaching sustained remission considered failures.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Weeks||Standard Deviation|Mean
2727867|NCT01034137|Secondary|Median Time to First Sustained Remission|It is the time to event analysis for the first period of sustained remission. Sustained remission is defined as DAS28 <2.6 during ≥23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts (range 0-28), acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||days||95% Confidence Interval|Median
2727868|NCT01034137|Primary|Percentage of Participants Achieving Sustained Remission Rate At Week 104|Sustained remission rate (SRR) is defined as Disease Activity Score 28 (DAS28) <2.6 during ≥ 23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 104|The intent to treat (ITT) population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsules and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
2727869|NCT01034111|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|Calculated as the mean change from baseline in fasting plasma glucose at Week 4.|Baseline and Week 4||||mmol/L||Standard Deviation|Mean
2727870|NCT01034111|Primary|Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment|Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.|4 weeks||||Participants|||Number
2727871|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 24|Not all participants answered every question|||participants|||Number
2727872|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 20|Not all participants answered every question|||participants|||Number
2727873|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 16|Not all participants answered every question.|||participants|||Number
2727874|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 12|Not all participants answered every question.|||participants|||Number
2730198|NCT01016873|Secondary|Change in Mean Visual Acuity (VA)||Weeks 12, 28, 52 and 104.||||Letters||Standard Deviation|Mean
2727878|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study."|Week 20|Not all participants answered every question|||percentage of participants|||Number
2727879|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study."|Week 16|Not all participants answered every question|||percentage of participants|||Number
2727880|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been on this study."|Week 12|Not all participants answered every question|||percentage of participants|||Number
2727881|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study."|Week 8|Not all participants answered every question|||percentage of participants|||Number
2727882|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study."|Week 4|Not all participants answered every question|||percentage of participants|||Number
2727883|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study."|Week 24|Not all participants answered every question|||percentage of participants|||Number
2727884|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study."|Week 20|Not all participants answered every question|||percentage of participants|||Number
2727885|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study."|Week 16|Not all participants answered every question|||percentage of participants|||Number
2727886|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study."|Week 12|Not all participants answered every question|||percentage of participants|||Number
2727887|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study."|Week 8|Not all participants answered every question|||percentage of participants|||Number
2727888|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study."|Week 4|Not all participants answered every question|||percentage of participants|||Number
2727889|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex."|Week 24|Not all participants answered every question|||percentage of participants|||Number
2727890|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex."|Week 20|Not all participants answered every question|||percentage of participants|||Number
2727891|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex."|Week 16|Not all participants answered every question|||percentage of participants|||Number
2727892|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex."|Week 12|Not all participants answered every question|||percentage of participants|||Number
2730199|NCT01016873|Primary|Number of Lucentis® Injections Up To And Including Week 52||During the first 52 weeks.||||Injections||Standard Deviation|Mean
2727894|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex."|Week 4|Not all participants answered every question|||percentage of participants|||Number
2727895|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."|Week 24|Not all participants answered every question|||percentage of participants|||Number
2727896|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."|Week 20|Not all participants answered every question|||percentage of participants|||Number
2727897|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."|Week 16|Not all participants answered every question|||percentage of participants|||Number
2727898|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."|Week 12|Not all participants answered every question|||percentage of participants|||Number
2727899|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."|Week 8|Not all participants answered every question|||percentage of participants|||Number
2727900|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex."|Week 4|Not all participants answered every question|||percentage of participants|||Number
2727901|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 24|Not all participants answered every question|||percentage of participants|||Number
2727902|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 20|Not all participants answered every question|||percentage of participants|||Number
2727903|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 16|Not all participants answered every question|||percentage of participants|||Number
2727904|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 12|Not all participants answered every question|||percentage of participants|||Number
2727905|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 8|Not all participants answered every question|||percentage of participants|||Number
2727906|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 4|Not all participants answered every question|||percentage of participants|||Number
2727907|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 24|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 24|Not all participants answered every question|||percentage of participants|||Number
2727908|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 20|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 20|Not all participants answered every question|||percentage of participants|||Number
2730200|NCT01016847|Secondary|Sputum Cell Counts and Differentials||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
2727911|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 8|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 8|Not all participants answered every question|||percentage of participants|||Number
2727912|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 4|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 4|Not all participants answered every question|||percentage of participants|||Number
2727913|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24||Week 24|Not all participants answered every question|||participants|||Number
2727914|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20||Week 20|Not all participants answered every question|||participants|||Number
2727915|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16||Week 16|Not all participants answered every question|||participants|||Number
2727916|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12||Week 12|Not all participants answered every question|||participants|||Number
2727917|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8||Week 8|Not all participants answered every question|||participants|||Number
2727918|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4||Week 4|Not all participants answered every question|||participants|||Number
2727919|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727920|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Ran Out of Study Pills||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727921|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727922|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Felt Sick or Ill||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727923|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727924|NCT01033942|Primary|Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727925|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727926|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727927|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727928|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727929|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Simply Forgot||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727930|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727931|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Was Away From Home||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
2727932|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 24|No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24.|||percentage of participants|||Number
2727933|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 20|One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20.|||percentage of participants|||Number
2727934|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 16|13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16.|||percentage of participants|||Number
2727935|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 12|One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12.|||percentage of participants|||Number
2727936|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 8|18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8.|||percentage of participants|||Number
2727937|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 4|Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4.|||percentage of participants|||Number
2727938|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Baseline|Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline.|||percentage of participants|||Number
2727939|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Overall|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|20 Weeks||||Missed doses||Full Range|Median
2727940|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 20|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 20||||Missed doses||Full Range|Median
2727941|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 16|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 16||||Missed doses||Full Range|Median
2727942|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 12|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 12||||Missed doses||Full Range|Median
2727943|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 8|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 8||||Missed doses||Full Range|Median
2727944|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 4|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 4||||Missed doses||Full Range|Median
2727945|NCT01033942|Primary|Number of Missed Doses Over Time Based on Self-Report Calendar Data|The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.|24 weeks||||Doses||Standard Error|Least Squares Mean
2727946|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 24|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 24||||Missed Doses||Full Range|Median
2728013|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Deviation|Mean
2727947|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 20|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 20||||Missed Doses||Full Range|Median
2727948|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 16|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 16||||Missed Doses||Full Range|Median
2727949|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 12|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 12||||Missed Doses||Full Range|Median
2727950|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 8|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 8||||Missed Doses||Full Range|Median
2727951|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 4|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|4 weeks||||Missed Doses||Full Range|Median
2727952|NCT01033942|Primary|Acceptability of Health Clinic for Study Visits||Week 24|Not all participants answered every question.|||participants|||Number
2727953|NCT01033942|Primary|Acceptability of Physical Examination by a Doctor||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727954|NCT01033942|Primary|Acceptability of Being Contacted by the Research Team in Between Visits||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727955|NCT01033942|Primary|Acceptability of Questions About Sexual Behavior at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727956|NCT01033942|Primary|Acceptability of Risk Reduction Counseling at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727957|NCT01033942|Primary|Acceptability of Having an HIV Test at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727958|NCT01033942|Primary|Acceptability of Being Randomly Assigned to a Group||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727959|NCT01033942|Primary|Acceptability of Participating in Group Sessions||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727960|NCT01033942|Primary|Acceptability of Taking Part in the Study||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727961|NCT01033942|Primary|Acceptability of Taking the Pill Everyday||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727962|NCT01033942|Primary|Acceptability of the Color of the Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727963|NCT01033942|Primary|Acceptability of the Taste of the Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
2727964|NCT01033942|Primary|Acceptability of Size of Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||Participants|||Number
2731950|NCT01004354|Secondary|HDL-cholesterol at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
2727965|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Baseline||||participants|||Number
2727966|NCT01033942|Primary|Actual Number of Study Visits Completed by 24 Weeks|This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.|24 weeks||||Visits||Standard Error|Least Squares Mean
2727967|NCT01033864|Secondary|Regression Coefficients For Participants Receiving MMF|The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).|Day 1 at 30 minutes and 1 and 2 hours postdose|PK population. Only participants in the MMF/Prednisone group were assessed for this outcome measure, n=12.|||mg/L|||Number
2727968|NCT01033864|Primary|Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)||Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||percentage of participants|||Number
2727969|NCT01033864|Primary|Dose-Normalized MPA AUC0-12|"Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg*h/L||Standard Deviation|Mean
2727970|NCT01033864|Primary|MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)|The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg*h/L||Standard Deviation|Mean
2727971|NCT01033864|Primary|Dose-Normalized Cmax (mg/L)|"Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
2727972|NCT01033864|Primary|Maximum Plasma Concentration (Cmax)|The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
2727973|NCT01033864|Primary|Dose-Normalized Cmin|"Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
2727974|NCT01033864|Primary|Minimum Plasma Concentration (Cmin)|The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
2727975|NCT01033864|Primary|Dose-Normalized C0|"Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)"|Day 1 predose|PK population|||mg/L||Standard Deviation|Mean
2727976|NCT01033864|Primary|Pre-dose Trough Concentration (C0)|The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).|Day 1 predose|Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available.|||mg/L||Standard Deviation|Mean
2727977|NCT01033851|Secondary|Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.|This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).|2 months|The population analyzed included all participants attending at least one class of an intervention.|||units on a scale||Standard Deviation|Mean
2727978|NCT01033851|Primary|Active Symptoms of Generalized Anxiety Disorder|The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.|2 months|The population analyzed included all participants who attended at least one class of an intervention.|||units on a scale||Standard Deviation|Mean
2727979|NCT01033825|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population|||percentage of devices|||Number
2727980|NCT01033825|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population|||Devices|||Number
2727981|NCT01033825|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population|||percentage of devices|||Number
2727982|NCT01033825|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population|||Devices|||Number
2727984|NCT01033825|Secondary|Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||Number of days|||Number
2727985|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727986|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2727987|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727988|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2727989|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727990|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2727991|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727992|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728014|NCT01033825|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population|||percentage of subjects|||Number
2732866|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||0 weeks|||||||
2727993|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727994|NCT01033825|Primary|The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period|Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|week 6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Error|Least Squares Mean
2727995|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2727996|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727997|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2727998|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2727999|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728000|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2728001|NCT01033825|Secondary|Baseline Daily Subject-reported PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728002|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2728003|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728004|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2728005|NCT01033825|Secondary|Baseline Daily Subject-reported AM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728006|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2728007|NCT01033825|Secondary|Baseline Daily Subject-reported PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728008|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
2728009|NCT01033825|Secondary|Baseline Daily Subject-reported AM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
2728010|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Error|Least Squares Mean
2728011|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Deviation|Mean
2728015|NCT01033825|Secondary|Number of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population|||participants|||Number
2728016|NCT01033825|Secondary|Percentage of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population|||percentage of subjects|||Number
2728017|NCT01033825|Secondary|Number of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population.|||participants|||Number
2728018|NCT01033825|Secondary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population|||percentage of subjects|||Number
2728019|NCT01033825|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population.|||participants|||Number
2728020|NCT01033825|Secondary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.|||percentage of subjects|||Number
2728021|NCT01033825|Secondary|Number of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.|||participants|||Number
2728022|NCT01033825|Primary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline|AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Deviation|Mean
2728023|NCT01033747|Secondary|Relative Change in Serum Ferritin From Baseline to 3.5 Years|The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline to 3.5 years|All participants comprised of the full analysis set were evaluated for the change in serum ferritin.|||Percent change||Full Range|Mean
2728024|NCT01033747|Primary|The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox|The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.|Baseline to 7 Years|All participants in the full analysis set treated with deferasirox for more than 3.5 years.|||Percent change||Full Range|Mean
2728025|NCT01033734|Secondary|Participants With Greater Than or Equal to (>=) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Day 1, 6 and 30|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.|||Participants|||Number
2728026|NCT01033734|Secondary|Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not collected because of changes in planned analysis, due to early study termination.||||||
2728027|NCT01033734|Secondary|Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.||||||
2728028|NCT01033734|Secondary|Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.||||||
2728029|NCT01033734|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
2728030|NCT01033734|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728031|NCT01033734|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
2730847|NCT01012167|Secondary|Vital Signs - Systolic Blood Pressure|Mean systolic blood pressure by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||mm-Hg||Standard Deviation|Mean
2728032|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728033|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728034|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728035|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728036|NCT01033734|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2728037|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728038|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728039|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728040|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2728041|NCT01033734|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.|||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2728042|NCT01033565|Primary|Clinical Global Impression-Improvement|Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.|2 weeks||||units on a scale|||Number
2728043|NCT01033487|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
2728044|NCT01033487|Secondary|Change From Baseline in Force Vital Capacity (FVC)|FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
2728045|NCT01033487|Secondary|Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 24.5 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
2728046|NCT01033487|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
2728047|NCT01033487|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.||||||
2728048|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.||||||
2758416|NCT00816777|Secondary|Tumor Response (RECIST)||1 year|Study terminated ealry||||||
2728049|NCT01033487|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.||||||
2728050|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||(pg*hr/mL)/mcg||Standard Deviation|Geometric Mean
2728051|NCT01033487|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||pg*hr/mL||Standard Deviation|Geometric Mean
2728052|NCT01033487|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||hr||Full Range|Median
2728053|NCT01033487|Primary|Dose Normalized Maximum Observed Plasma Concentration|Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||(pg/mL)/mcg||Standard Deviation|Geometric Mean
2728054|NCT01033487|Primary|Maximum Observed Plasma Concentration (Cmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||Picogram/milliliter (pg/mL)||Standard Deviation|Geometric Mean
2728055|NCT01033487|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.|Baseline, 24, 24.5 hrs post-dose|Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
2728056|NCT01033448|Secondary|Percentage of Participants With Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 96|All enrolled participants were analyzed|||Percentage of Participants|||Number
2728057|NCT01033448|Primary|SVR Rates in Genotype 2 and 3.|Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.|Week 72|Participants with CHC Genotype 2 & 3 at week 72.|||Percentage of participants||95% Confidence Interval|Number
2728058|NCT01033448|Primary|Sustained Viral Response (SVR) Rates in CHC Genotype 1|Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.|Week 96|Participants with CHC genotype 1 at Week 96|||Percentage of participants||95% Confidence Interval|Number
2728059|NCT01033448|Primary|End of Treatment Response in Genotype 2 and 3|End of treatment response rate at Week 48 was reported for genotype 2 and 3.|Week 48|Participants with CHC Genotype 2 and 3 at Week 48.|||Percentage of Participants|||Number
2728060|NCT01033448|Primary|End of Treatment Response Rate at Week 72 in Genotype 1|End of treatment response rate at Week 72 was reported for genotype 1.|Week 72|Participants with genotype 1 CHC at Week 72.|||Percentage of Participants|||Number
2728061|NCT01033422|Secondary|Safety: Frequency of Adverse Events|Frequency of adverse events|16 weeks||2020-12-31|12/2020||||
2728062|NCT01033422|Primary|Intraocular Pressure in mmHg|The mean of the IOP measurements obtained at week 16|16 weeks||||Intraocular Pressure in mmHg||Standard Deviation|Mean
2728063|NCT01033383|Secondary|Not Growth|The number of not growth, these include no growth, growth <100,000 CFU/ml, growth >100,000 CFU/ml but no WBCs, and mixed flora.|one month|The analysis population were those with completed labs data.|||urine cultures and urinalyses|Participants||Number
2728064|NCT01033383|Secondary|Other Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) >100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.|one month|The analysis population were those with completed labs data.|||urine cultures and urinalyses|Participants||Number
2728065|NCT01033383|Primary|E.Coli Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.|One month|The analysis population were those with completed labs data.|||urine cultures and urinalyses|Participants||Number
2728066|NCT01033227|Secondary|Secondary End Point|a) reduced the duration and intensity of pain; b) reduced total narcotic analgesic consumption; and c) reduced length of hospitalization.|48 hours|Data were *not collected* and the Outcome was never analyzed, study terminated||||||
2728067|NCT01033227|Primary|48 Hour Sodium Nitrite Infusion Safety as Determined by Number of Participants With No Adverse Events|The primary end points will be to determine if a) a 48-hour sodium nitrite infusion is tolerated without a decrease in mean arterial blood pressure by 15mmHg for greater than 2 hours or development of methemoglobin greater than 5% and b) a 48-hour sodium nitrite infusion is safe as determined by monitoring for adverse events|48 hours from start of infusion||||Participants|||Count of Participants
2728068|NCT01033136|Primary|Change in PDSS Scores Over Time for MCET-V and CPT Groups|The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.|Baseline, 1-week post, and 3-month follow-up||||units on a scale||Standard Deviation|Mean
2728069|NCT01033136|Primary|Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups|The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.|Baseline, 1-week post-treatment and 3-month follow-up||||units on a scale||Standard Deviation|Mean
2728070|NCT01033071|Secondary|Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the non-missing values of the 3 serial trough sitting blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||percent of participants|||Number
2728071|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||percentage of participants|||Number
2728072|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the non-missing values of the 3serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||percentage of participants|||Number
2728073|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728074|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728075|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728076|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728077|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728078|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728079|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728080|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728081|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728082|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728083|NCT01033071|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728084|NCT01033071|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728085|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.|The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728086|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728087|NCT01033071|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2728088|NCT01033032|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)|||participants|||Number
2728089|NCT01033032|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 6 weeks until treatment discontinuation, expected average of 18 months|Includes patients treated at the MTD (Dose Level 3)|||months||95% Confidence Interval|Median
2728090|NCT01033032|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)|||participants|||Number
2728634|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 6 weeks after drug administration|Safety population|||Participants|||Number
2728091|NCT01033032|Primary|Progression-free Survival (PFS)|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 6 weeks until progressive disease|Includes patients treated at the MTD (Dose Level 3)|||months||95% Confidence Interval|Median
2728092|NCT01033019|Primary|Clinical Evaluation of sBCCs Tumors|The clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|Day 43|Efficacy analysis set: the efficacy analysis set included all randomized participants with evaluable data.|||Participants|||Number
2728093|NCT01032993|Secondary|Percentage of Participants With Adverse Effects|serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.|4 weeks|3 serious adverse events occurred during the study that were judged unrelated to the study: specifically, 3 participants were hospitalized prior to randomization, 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.|||% of participants reporting|||Number
2728094|NCT01032993|Secondary|Percentage of Participants With Improvement in Disability Related to Muscle Pain|Disability improvement was based on patient report of improvement they felt was meaningful to them|4 weeks||||% reporting improved function|||Number
2728095|NCT01032993|Secondary|Continuation of Statin|Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.|4 weeks||||participants|||Number
2728096|NCT01032993|Primary|Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use|Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10|4 weeks||||% of participants with pain reduction|||Number
2728097|NCT01032928|Primary|Optimal Respiratory - Swallow Phase|Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks||||percentage of swallows|||Number
2728098|NCT01032928|Secondary|Percentage of Impairment According to the Penetration-Aspiration Scale|The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores < 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks||||percentage of swallows with impaired PAS|||Number
2728099|NCT01032928|Secondary|Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)|Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks||||percentage of impairment|||Number
2728100|NCT01032915|Secondary|Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Score||Standard Deviation|Mean
2728101|NCT01032915|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score.|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Letters||Standard Deviation|Mean
2728112|NCT01032850|Primary|Number of Participants Experiencing Adverse Events|The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.|6 months||||participants|||Number
2728113|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics|The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.|Day 1 through Day 40|ITTI population|||participants|||Number
2728114|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses During the Study|The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.|Day 1 through Day 40|ITTI population|||participants|||Number
2728102|NCT01032915|Secondary|Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks|Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS (or its reduction from baseline) showed better clinical outcome|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Score||Standard Deviation|Mean
2728103|NCT01032915|Primary|Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Days||95% Confidence Interval|Median
2728104|NCT01032889|Secondary|Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.|||mm||95% Confidence Interval|Least Squares Mean
2728105|NCT01032889|Secondary|Change From Baseline in Submental Fat Volume|Submental fat volume was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.|||mm³||95% Confidence Interval|Least Squares Mean
2728106|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728107|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728108|NCT01032889|Primary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified Intent-to-Treat (mITT) population including all randomized participants who received at least 1 injection of study drug and had at least 1 post-baseline observation for CR-SMFRS, Subject Self-Rating Scale (SSRS), or magnetic resonance imaging (MRI) volume. Last observation carried forward (LOCF) method was used to impute missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728109|NCT01032850|Secondary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years||||months||95% Confidence Interval|Median
2728110|NCT01032850|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|5 years||||Months||95% Confidence Interval|Median
2728111|NCT01032850|Secondary|Disease Control Rate of Response (DCR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease|6 months||||percentage of participants|||Number
2767274|NCT00759096|Secondary|Contrast Sensitivity||6 months after sugery of the 2nd eye|||||||
2728115|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Adults|Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including adults only (>12 years old).|||hours||95% Confidence Interval|Median
2728116|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Children|Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including children only (ages 1 - 12 years).|||hours||95% Confidence Interval|Median
2728117|NCT01032837|Secondary|Time to Resolution of Fever|Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.|Day 1 through Day 40|ITTI population with fever at Baseline.|||hours||95% Confidence Interval|Median
2728118|NCT01032837|Secondary|Number of Participants With Development of Oseltamivir-Resistant Influenza Virus|The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.|40 days|ITTI Population|||participants|||Number
2728119|NCT01032837|Secondary|Change From Baseline in Influenza Titer Measured by Viral Culture|Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).|Baseline, Days 2 through 15|ITTI|||Log10 TCID50||Standard Deviation|Mean
2728120|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction|Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI|||percentage of participants|||Number
2728121|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture|Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI|||percentage of participants|||Number
2728122|NCT01032837|Primary|Time to Cessation of Viral Shedding|The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.|Day 1 to Day 40|ITT infected (ITTI) Population, including all patients randomized who received at least one dose of study medication with laboratory confirmation of pandemic (H1N1) 2009 influenza infection, excluding patients infected with oseltamivir-resistant influenza A H1N1 H275Y at baseline and patients not shedding virus at baseline.|||hours||95% Confidence Interval|Median
2728123|NCT01032759|Secondary|Chronic Post-surgical Pain||1 month, 3 month, 6 month|Data was not collected and therefore not analyzed.||||||
2728124|NCT01032759|Secondary|Patient Satisfaction|"Number of participants who reported very satisfied or somewhat satisfied"|48 hours|Number of participants who had this outcome reported and documented.|||participants|||Number
2728125|NCT01032759|Secondary|Hyperalgesia|"Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a painful, sore, or sharper feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision."|Within 48 h|Number of participants who had this outcome measured and documented|||cm2||Standard Deviation|Mean
2728126|NCT01032759|Secondary|Opioid Related Side Effects: Pruritus|Number of participants who experienced pruritus.|0-24 h||||participants|||Number
2728127|NCT01032759|Secondary|Opioid Related Side Effects|Number of participants with postoperative nausea and vomiting.|0-24 h||||participants|||Number
2728128|NCT01032759|Primary|24 hr Opioid Consumption||24 hr|Participants who completed the 24 hour assessment.|||mg morphine equivalents||Standard Deviation|Mean
2728129|NCT01032759|Secondary|Pain Scores|Pain score (0=no pain, 10= worst possible pain)|48 hours|Participants who completed the 48 hour assessment.|||units on a scale||Standard Deviation|Mean
2728130|NCT01032733|Secondary|Mitochondrial Function (Cox IV Subunit)|Western blot analysis was performed to determine complex content. The amount of Cox IV subunit was determined for each Reporting Group via Western Blot analysis at baseline and week 24.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. In addition, the discrepancy for the number of participants is becasue we could only obtain information on a subset of participants due to the nature of the procedure (muscule biopsy).|||fold change (ug/ml)||Standard Deviation|Mean
2728183|NCT01032382|Secondary|Number of Index Lesions Meeting Criteria for Clinical Cure During the Study|Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study.|Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168||||Lesions meeting clinical cure criteria|||Number
2743528|NCT00927784|Primary|Incidence of Myocardial Rupture||Measured within 90 days of study entry||||participants|||Number
2728131|NCT01032733|Secondary|Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).|Maximal knee extension strength using each participant's strongest leg was measured using a Biodex. The participants were asked to develop their maximal isokinetic knee extension strength. Three trials of 5 repetitions were performed and the peak torque value was used for statistical analyses.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.|||kilograms||Standard Deviation|Mean
2728132|NCT01032733|Secondary|Short Physical Performance Battery|Scores on the Short Physical Performance Battery (SPPB) were obtained at baseline and at the 24-week post-treatment assessment visit. The SPPB consists of a 4 meter walk, repeated chair stands, and three hierarchical standing balance tests. The time to complete each of the three performance measures was assigned a categorical score based on normative data, ranging from 0 to 4. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding walking speed, chair stands, and balance scores.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.|||score on the SPPB||Standard Deviation|Mean
2728133|NCT01032733|Secondary|Body Weight|Body weight was measured under fasting conditions following voiding in the morning at baseline and at the 24-week post-treatment assessment.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so 'centered' with a baseline carried forward mechanism).|||kilograms||Standard Deviation|Mean
2728134|NCT01032733|Primary|Performance on the 400 Meter Walk|Walking speed was assessed at baseline and 24-week assessment by the 400 Meter Walk Test, during which participants were asked to complete a standard walking course at their usual pace. Participants were permitted to stop during the walk but were not allowed to sit or receive help from others and were required to complete the course in 15 minutes.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so ‘centered’ with a baseline carried forward mechanism).|||meters per second||Standard Deviation|Mean
2728135|NCT01032694|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percentage of Participants|||Number
2728136|NCT01032694|Secondary|Percent Compliance With the Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percent compliance||Standard Deviation|Mean
2728137|NCT01032694|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.|Days 11-12|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. Missing observations were not imputed. 'N' signifies the number of participants with non-missing data.|||Percentage of Participants|||Number
2728138|NCT01032629|Secondary|Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment|Change from baseline in LDL-C to HDL-C ratio was assessed.|Baseline and end of treatment (approximately 338 weeks)|On-treatment set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline lipid measurements.|||Ratio||Standard Error|Least Squares Mean
2728139|NCT01032629|Secondary|Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment|Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.|Baseline and end of treatment (approximately 338 weeks)|On-treatment set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline lipid measurements.|||mmol/L||Standard Error|Least Squares Mean
2728140|NCT01032629|Secondary|Change From Baseline in Triglycerides Levels at End-of-Treatment|Change from baseline in triglycerides levels was assessed.|Baseline and end of treatment (approximately 338 weeks)|On-treatment set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline lipid measurements.|||mmol/L||Standard Deviation|Mean
2728141|NCT01032629|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment|Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure who and had both baseline and post-baseline blood pressure measurements.|||Millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
2728242|NCT01032174|Secondary|Percent Compliance With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percent compliance||Standard Deviation|Mean
2728142|NCT01032629|Secondary|Percent Change From Baseline in Body Weight at End-of-Treatment|Percent change from baseline in body weight was assessed at the end of treatment.|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and who had both baseline and post-baseline body weight.|||Percent change||Standard Error|Least Squares Mean
2728143|NCT01032629|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment|Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and had both baseline and post-baseline fasting plasma glucose measurements.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2728144|NCT01032629|Secondary|Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment|Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood.|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure who had both baseline and any post-baseline HbA1C measurements.|||HbA1c (%)||Standard Error|Least Squares Mean
2728145|NCT01032629|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment|Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black).|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure who had both baseline and post-baseline eGFR measurements.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2728146|NCT01032629|Secondary|Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment|Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.|Baseline and End of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and had both baseline and post-baseline ACR measurements.|||Milligram per gram (mg/g)||95% Confidence Interval|Geometric Mean
2728147|NCT01032629|Secondary|Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment|A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set: all randomized participants who received at least 1 dose of study drug. 'N' (number of participants analyzed): number of participants evaluable for this outcome measure, had both baseline and any post-baseline PI/I ratio measurements on-treatment prior to initiation of insulin and didn’t receive insulin through baseline.|||Picomole per milli international units||Standard Error|Least Squares Mean
2728148|NCT01032629|Secondary|Percentage of Participants With Progression of Albuminuria at the End-of-Treatment|Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed.|End of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies number of participants who were treated, had both baseline and post−baseline ACR measurements, and baseline ACR<=300 mg/g.|||Percentage of participants|||Number
2728149|NCT01032629|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent.|Baseline and end of treatment (approximately 338 weeks)|On-treatment analysis set included all randomized participants who received at least 1 dose of study drug. Here 'N' (number of participants analyzed) included subset of participants who were not receiving insulin at baseline and had at least one post-baseline HOMA2-%B measurement on-treatment prior to initiation of insulin.|||Percentage of HOMA2||Standard Error|Least Squares Mean
2728150|NCT01032629|Primary|Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke|MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.|Up to approximately 8 years|The primary analysis was based on the intent-to-treat (ITT) analysis set for adjudicated MACE, and included all randomized participants. As per planned analysis, the results were reported separately and combined for both doses.|||Events per 1000 patient-year|||Number
2728318|NCT01031706|Primary|Change in Mucociliary Clearance Rate|"Average radio tracer clearance through 90 minutes (MCC90) is primary index of mucociliary clearance at each study.~Primary study outcome: is absolute change in MCC90 between baseline and at end of treatment (where MCC measured 8-12 hours after final dose of study drug) - reflects sustained impact on MCC"|Baseline versus after completion of 4 week treatment period|All subjects with available data analyzed|||percent clearance||Standard Error|Mean
2728151|NCT01032603|Secondary|Participants Suboptimal Surgical Outcome at 3 Years|"Suboptimal surgical outcome at the 3-year visit was defined as meeting any of the three suboptimal surgical outcome criteria at the 3-year visit (regardless of whether the criterion had been met at an earlier visit), or undergoing reoperation at any time.~The three criteria for suboptimal surgical outcome were:~Exotropia at distance OR near at any time during the exam (i.e., can be constant or intermittent; determined by a cover/uncover test) with a magnitude of ≥10Δ by SPCT, confirmed by a retest~Constant esotropia at distance OR near (determined by at least 3 cover/uncover tests—one must be before any dissociation) with a magnitude of ≥6Δ by SPCT, confirmed by a retest~Decrease in Randot Preschool near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest"|3 years after enrollment|Includes only those who completed the 3 year visit.|||Participants|||Count of Participants
2728152|NCT01032603|Secondary|Number of Participants With Complete or Near-Complete Resolution at 3 Years|Complete or near-complete resolution was defined as meeting all of the following at the 3 year visit: 1) exodeviation <10 Δ (tropia or phoria) by both SPCT and PACT at distance and near and ≥10 Δ reduction in PACT magnitude from the largest of the distance and near angles at enrollment, 2) esotropia <6 Δ at distance and near by SPCT, 3) no decrease in Randot Preschool stereoacuity of ≥2 octaves from the enrollment stereoacuity or to nil, 4) no reoperation or treatment with botulinum toxin, and 5) no non-surgical treatment for a recurrent or residual exodeviation.|3 years after enrollment|Includes only those patients that completed the 3-year visit.|||Participants|||Count of Participants
2728153|NCT01032603|Secondary|Cumulative Number of Patients With Reoperation by 3 Years|"The cumulative proportion of re-operation by 3 years was compared between treatment groups using methods similar to the primary analysis (i.e. using Kaplan-Meier method). A treatment-group difference and a corresponding 95% confidence interval were also calculated. Reasons for re-operation included:~XT; XT and worsening stereo ; XT, worsening stereo and social concerns ; XT, diplopia, and headaches ; XT and squinting with one eye closed ; ET ; ET, worsening stereo, and diplopia; ET, worsening stereo and social concerns ; ET, worsening stereo, social concerns, and amblyopia ; Inferior oblique overaction"|3 years after enrollment||||Participants|||Count of Participants
2728154|NCT01032603|Secondary|Health Related Quality of Life|"Health-related quality of life will be assessed using the Intermittent Exotropia Questionnaire (IXTQ). This questionnaire consists of 6 components:~Child questionnaire - consists of 12 items which assess how the child feels about his/her eye condition.~One version for children aged 5 to < 8 years has a 3-level response scale~The version for children aged 8 years and older has a 5-level response scale~Parent proxy questionnaire - consists of 12 items which assess how the parent feels the child's eye condition affects the child~Parental questionnaire - consists of 17 items which assess how the child's eye condition affects the parent. Has 3 sub-scales: surgical, functional, and psycho-social.~All scales ranged from 0 to 100; higher values indicated a better quality of life. Sub-scales were not combined, but rather were each evaluated individually on a scale of 0-100."|3 years after enrollment|The total number of children/patients was split between two categories: younger and older, which is why the number analyzed is different between rows. 1 patient in the BLR group and 2 patients in the RR group were missing quality of life questionnaire data. Parent information was not missing which is why the total number is equal to number analyzed|||score on a scale||Full Range|Median
2728155|NCT01032603|Secondary|Change in Distance Stereoacuity From Baseline to 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec).~Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement."|Enrollment to 3 years|Range of the mean was -0.9 to 1.1 for the BLR group and -0.8 to 1.1 for the RR group.|||logarithm of seconds of arc (log arcsec)||Standard Deviation|Mean
2728156|NCT01032603|Secondary|Mean Distance Stereoacuity at 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec).~Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following:~Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility.~Distance Randot stereotest (performed at 3 meters)"|3 years after enrollment|Range of the mean was 1.8 to 2.9 for both the BLR and RR groups.|||logarithm of seconds of arc (log arcsec||Standard Deviation|Mean
2728157|NCT01032603|Secondary|Participants Distance Stereoacuity at 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following:~Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility.~Distance Randot stereotest (performed at 3 meters)"|3 years after enrollment||||Participants|||Count of Participants
2728158|NCT01032603|Secondary|Change in Near Stereoacuity From Baseline to 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec).~Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement."|Enrollment to 3 years|Range of the mean was -1.3 to 1.0 for the BLR group and -1.4 to 1.0 for the RR group.|||logarithm of seconds of arc (log arcsec)||Standard Deviation|Mean
2728398|NCT01031004|Primary|Corneal Edema at Month 1|Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728159|NCT01032603|Secondary|Mean Near Stereoacuity at 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec).~Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following:~Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility.~Distance Randot stereotest (performed at 3 meters)"|3 years after enrollment|The range of the mean was -1.6 to 3.2 for both the BLR and RR groups.|||logarithm of seconds of arc (log arcsec)||Standard Deviation|Mean
2728160|NCT01032603|Secondary|Participants With Near Stereoacuity Measures at 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following:~Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility.~Distance Randot stereotest (performed at 3 meters)"|3 years after enrollment|Includes only patients who completed the 3-year visit.|||Participants|||Count of Participants
2728161|NCT01032603|Secondary|Change in Near PACT From Baseline to 3 Years|The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement. If the 3-year PACT is an esodeviation, change in PACT from baseline is the reduction in the exodeviation plus the amount of the 3-year exodeviation.|Enrollment to 3 years|Range of the mean was -14 to 44 for the BLR group and -12 to 41 for the RR group.|||prism diopters||Standard Deviation|Mean
2728162|NCT01032603|Secondary|Mean Near PACT at 3 Years|The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Mean PACT was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. PACT was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year PACT at near will adjust for baseline PACT at near).|3 years after enrollment|Range of the mean was -14 to 40 for the BLR group and -6 to 30 for the RR group.|||prism diopters||Standard Deviation|Mean
2728163|NCT01032603|Secondary|Number of Participants With Near PACT at 3 Years|"The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. PACT was assessed in all patients who completed the 3-year visit.~∆ = prism diopters; eso = esodeviation; exo = exodeviation"|3 years after enrollment||||Participants|||Count of Participants
2728164|NCT01032603|Secondary|Change in Distance PACT From Baseline to 3 Years|The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement. If the 3-year PACT is an esodeviation, change in PACT from baseline is the reduction in the exodeviation plus the amount of the 3-year exodeviation.|Enrollment to 3 years|Range of the mean was -10 to 44 for the BLR group and -5 to 36 for the RR group.|||prism diopters||Standard Deviation|Mean
2728165|NCT01032603|Secondary|Mean Distance PACT at 3 Years|The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Mean PACT was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. PACT was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year PACT at distance will adjust for baseline PACT at distance).|3 years after enrollment|Range of the mean was -14 to 35 for the BLR group and -6 to 30 for the RR group.|||prism diopters||Standard Deviation|Mean
2728166|NCT01032603|Secondary|Number of Participants With Distance PACT at 3 Years|"The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. PACT was assessed in all patients who completed the 3-year visit.~∆ = prism diopters; eso = esodeviation; exo = exodeviation"|3 years after enrollment||||Participants|||Count of Participants
2728167|NCT01032603|Secondary|Change in Near Exotropia Control at 3 Years|"Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|Enrollment to 3 Years|Range of the mean was -3 to 4 for both the BLR and RR groups.|||score on a scale||Standard Deviation|Mean
2728197|NCT01032330|Secondary|PACT Exodeviation at Distance - 6 Months|"The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time).~log arcsec = logarithm of seconds of arc; Δ = prism diopter"|6 months|For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.|||prism diopters||Standard Deviation|Mean
2728168|NCT01032603|Secondary|Mean Near Control at 3 Years|"Mean exotropia control at near was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. Control at near was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|3 years after enrollment|Range of the mean was 0 to 5 for the BLR group and 0 to 4 for the RR group.|||score on a scale||Standard Deviation|Mean
2728169|NCT01032603|Secondary|Number of Participants With Exotropia Control at Near at 3 Years|"Exotropia control at near was assessed in all patients who completed the 3-year visit.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|3 years after enrollment|Includes only patients who completed the 3-year visit.|||Participants|||Count of Participants
2728170|NCT01032603|Secondary|Change in Distance Exotropia Control at 3 Years|"Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|Enrollment to 3 years|Range of the mean was -3 to 5 for the BLR group and -2 to 5 for the RR group.|||score on a scale||Standard Deviation|Mean
2728171|NCT01032603|Secondary|Mean Distance Control at 3 Years|"Mean exotropia control at distance was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. Control at distance was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|3 years after enrollment|Range of the mean was 0 to 5 for both the BLR group and for the RR group.|||score on a scale||Standard Deviation|Mean
2728172|NCT01032603|Secondary|Number of Participants With Exotropia Control at Distance at 3 Years|"Exotropia control at distance was assessed in all patients who completed the 3-year visit. Numeric values for exotropia control were assigned so that the following seven categories were created:~Not applicable (no exodeviation) (0) No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia"|3 years after enrollment|Includes only patients who completed the 3-year visit.|||Participants|||Count of Participants
2728173|NCT01032603|Secondary|Number of Participants With Stereo Loss by 3 Years|Decrease in Preschool Randot near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest, by 3 years. Criteria was met before any reoperation, and regardless of whether suboptimal surgical outcome was met by another criteria.|Enrollment to 3 years||||Participants|||Count of Participants
2728174|NCT01032603|Secondary|Patients With Constant Esotropia by 3 Years|Constant esotropia ≥6Δ by simultaneous prism and cover test (SPCT) at distance or near, confirmed by a retest, by 3 years. Criteria was met before any reoperation, and regardless of whether suboptimal surgical outcome was met by another criteria.|Enrollment to 3 years||||Participants|||Count of Participants
2728175|NCT01032603|Secondary|Patients With Exotropia by 3 Years|Exotropia ≥10Δ by simultaneous prism and cover test (SPCT) at distance or near, confirmed by a retest, by 3 years. Criteria was met before any reoperation, and regardless of whether suboptimal surgical outcome was met by another criteria.|Enrollment to 3 years||||Participants|||Count of Participants
2728176|NCT01032603|Primary|Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years|"A participant's intermittent exotropia (IXT) was considered to be a suboptimal surgical outcome if at any visit occurring 6 months or later, ANY of the following criteria are present by masked examiner testing:~Exotropia at distance OR near at any time during the exam (i.e., can be constant or intermittent; determined by a cover/uncover test) with a magnitude of ≥10Δ by SPCT, confirmed by a retest~Constant esotropia at distance OR near (determined by at least 3 cover/uncover tests—one must be before any dissociation) with a magnitude of ≥6Δ by SPCT, confirmed by a retest~Decrease in Randot Preschool near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest Participants who underwent reoperation (or treatment with botulinum toxin) without first meeting any of the above suboptimal surgical outcome criteria were also counted as suboptimal surgical outcomes in the primary analysis."|3 years||||Participants|||Count of Participants
2728177|NCT01032538|Secondary|Oxford Knee Score||10 years postoperatively|||||||
2728178|NCT01032538|Secondary|Knee Injury and Osteoarthritis Outcome Score||10 years postoperatively|||||||
2728179|NCT01032538|Secondary|UCLA Score||Preoperative until 2 years postoperatively|||||||
2728180|NCT01032538|Secondary|Oxford Knee Score||Preoperative until 2 years postoperatively|||||||
2728181|NCT01032538|Secondary|Range of Motion||Preoperative until 2 years postoperatively||||degrees||95% Confidence Interval|Mean
2728182|NCT01032538|Primary|Knee Injury and Osteoarthritis Outcome Score|Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.|Preoperative until 2 years postoperatively||||units on a scale||95% Confidence Interval|Mean
2728184|NCT01032382|Secondary|Final Clinical Cure on All Lesions Independent of Subjects|"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND,~Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168||||Cured ulcerated lesions|Participants||Number
2728185|NCT01032382|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults (18+ years)|||hr/ML||Standard Deviation|Mean
2728186|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)|||1/ML||Standard Deviation|Mean
2728187|NCT01032382|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). WR 279,396 group measurements Day 1 N = 2 and Day 20 N = 4. One study participant in the Paromomycin Alone Treatment was withdrawn at Day 100.|||hr||Standard Deviation|Mean
2728188|NCT01032382|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)|||ng*hr/mL||Standard Deviation|Mean
2728189|NCT01032382|Secondary|Pharmacokinetic Parameter: Tmax|Pharmacokinetic Parameter: Tmax|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). On day 1, Paromomycin Alone Treatment group N = 4; WR 279,396 group N = 3.|||hr||Standard Deviation|Mean
2728190|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)|||ng/mL||Standard Deviation|Mean
2728191|NCT01032382|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|0 and 4 hours on days 1 and 20|Children ages 5 to 17 (inclusive)|||ng/mL||Standard Deviation|Mean
2728192|NCT01032382|Secondary|Detectable Paromomycin Plasma Levels|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4, 7, 12, 17, 20, 28|Adults (18+ years)|||ng/mL||Standard Deviation|Mean
2728193|NCT01032382|Primary|Final Clinical Cure for Index Lesions|"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,~Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168||||participants|||Number
2728194|NCT01032330|Secondary|PACT at Near - 3 Years|"The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time).~Improvement in PACT at near was defined as a decrease of ≥13∆ because this amount exceed the repeatability coefficient of 12.8∆ for PACT angles larger than 20∆ at near.~log arcsec = logarithm of seconds of arc; Δ = prism diopter"|3 years|Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.|||prism diopters||Standard Deviation|Mean
2728195|NCT01032330|Secondary|PACT at Near - 6 Months|"The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time).~log arcsec = logarithm of seconds of arc; Δ = prism diopter"|6 months|For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.|||prism diopters||Standard Deviation|Mean
2728196|NCT01032330|Secondary|PACT at Distance - 3 Years|"The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time). Improvement in PACT at distance was defined as a decrease of ≥8∆ because this amount exceed the repeatability coefficient of 7.2∆ for PACT angles larger than 20∆ at distance.~log arcsec = logarithm of seconds of arc; Δ = prism diopter"|3 years|Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.|||prism diopters||Standard Deviation|Mean
2728213|NCT01032291|Secondary|Kaplan-Meier Estimates for Duration of Response|"Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR).~Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
2771077|NCT00731198|Secondary|Percentage of Successful Selective Cannulation||Intra-procedure|||||||
2728198|NCT01032330|Secondary|Exotropia Control at Near - 3 Years|"Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|3 years|Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.|||score on a scale||Standard Deviation|Mean
2728199|NCT01032330|Secondary|Exotropia Control at Near - 6 Months|"Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|6 months|For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.|||score on a scale||Standard Deviation|Mean
2728200|NCT01032330|Secondary|Exotropia Control at Distance - 3 Years|"Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|3 years|Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.|||score on a scale||Standard Deviation|Mean
2728201|NCT01032330|Secondary|Exotropia Control at Distance - 6 Months|"Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change.~Numeric values for exotropia control were assigned so that the following categories were created:~Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers <1 secs (phoria)~No exotropia unless dissociated, recovers 1-5 secs~No exotropia unless dissociated, recovers >5 secs~Exotropia <50% of 30-second observation~Exotropia >50% of 30-second observation~Constant exotropia~Lower scores indicate better control."|6 months|For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.|||score on a scale||Standard Deviation|Mean
2728202|NCT01032330|Secondary|Near Stereoacuity - 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at near is reported at 3 years, as is the change in near stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. For change in stereo, positive change indicates improvement in stereo."|between baseline and 3 years|The older cohort occlusion therapy group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.|||log arcsec||Standard Deviation|Mean
2728203|NCT01032330|Secondary|Near Stereoacuity - 6 Months|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at near is reported at 3 years, as is the change in near stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec.~Outcome based on initial testing regardless of whether a retest was completed for suspected deterioration. Change is calculated as baseline level minus 6-month level. For change in stereo, positive change indicates improvement in stereo."|6 months|Stereoacuity data is missing for 2 observation group participants because it was not tested at the visit at which treatment was started in the absence of meeting deterioration criteria. The 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.|||log arsec||Standard Deviation|Mean
2728214|NCT01032291|Secondary|Kaplan-Meier Estimates for Progression Free Survival (PFS)|"PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause.~Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
2728241|NCT01032174|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percentage of Participants|||Number
2728204|NCT01032330|Secondary|Distance Stereoacuity - 3 Years|"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.~A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at distance is reported at 3 years, as is the change in distance stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. For change in stereo, positive change indicates improvement in stereo."|Between baseline and 3 years|Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation group, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.|||log arsec||Standard Deviation|Mean
2728205|NCT01032330|Primary|Deterioration by 3 Years - Younger Cohort|The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was deﬁned as a constant exotropia of 10 D or more at distance and near by SPCT, conﬁrmed by a retest, during any masked examination between 3 months and 3 years after randomization.|3 years|The younger cohort occlusion therapy group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.|||Participants|||Count of Participants
2728206|NCT01032330|Primary|Deterioration by 6 Months - Younger Cohort|The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was deﬁned as a constant exotropia of 10 D or more at distance and near by SPCT, conﬁrmed by a retest, at either the 3- or 6-month visit.|6 months|Previously untreated children aged 12 to 35 months. Motor deterioration was measured by simultaneous prism and cover test.|||Participants|||Count of Participants
2728207|NCT01032330|Primary|Deterioration by 3 Years - Older Cohort|The primary outcome measure for this study was whether the participant's condition had deteriorated within 3 years after randomization. Deterioration was defined as meeting one or both of the following criteria during any masked examination between 3 months and 3 years after randomization: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.|3 years|The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. Because only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis.|||Participants|||Count of Participants
2728208|NCT01032330|Primary|Deterioration by 6 Months - Older Cohort|The primary outcome measure for this study was whether the participant's condition had deteriorated within 6 months after randomization. Deterioration was defined as meeting one or both of the following criteria during a masked examination at either the 3-month or 6-month visit: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.|6 months|Previously untreated children aged 3 to <11 years. The 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.|||Participants|||Count of Participants
2728209|NCT01032291|Primary|Percentage of Participants With a Response to Treatment During the Proof of Concept Period|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).~Treatment response includes both complete response and partial response.~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Analysis was not performed due to the early termination of the study."|week 9 up to week 24|Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study.||||||
2728210|NCT01032291|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.|up to week 28|Participants who took at least one dose of study treatment.|||participants|||Number
2728211|NCT01032291|Secondary|Kaplan-Meier Estimates for Overall Survival|"Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment.~Analysis was not performed due to the early termination of the study."|up to 5.5 years|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
2728212|NCT01032291|Secondary|Percentage of Participants With Disease Control|"Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR.~This analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
2728635|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|before and 3 weeks after surgery|ITT|||Participants|||Number
2728215|NCT01032291|Post-Hoc|Best Overall Response Assessed by an Independent Review Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) During the Proof of Concept Period Prior to Early Study Termination|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions.~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.~Participants with evidence of objective tumor response have the response confirmed with repeat assessments performed at the next scheduled scan."|Week 9 up to week 24|Intent to treat population.|||participants|||Number
2728216|NCT01032291|Primary|Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period|"The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period:~If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg.~If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide.~If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg.~If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide.~If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg.~If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators."|Up to Day 28 (Cycle 1)|All participants who took at least one dose of study medication. If a participant discontinued the study prior to completing the entire first cycle for reasons other than a DLT or if ≥7 days of lenalidomide and/or ≥1 dose of cetuximab were missed during the first cycle for reasons other than a DLT, a replacement would be added at that dose level.|||participants|||Number
2728217|NCT01032265|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)||4 months|Intention-to-treat|||participants|||Number
2728218|NCT01032265|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, 4 months|Intention-to-treat|||episodes per week||Standard Deviation|Mean
2728219|NCT01032265|Secondary|Patient Satisfaction||4 months|Intention-to-treat|||participants|||Number
2728220|NCT01032265|Secondary|Usage of Incontinence Aids|Only those using incontinence aids at baseline were included in the analysis.|baseline, 4 months|Intention-to-treat|||participants|||Number
2728221|NCT01032265|Secondary|EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)|health-specific quality of life, range 0-100, higher scores indicate better quality of life.|baseline, 4 months|Intention-to-treat|||units on a scale||Standard Deviation|Mean
2728222|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.|baseline, 4 months|Intention-to-treat|||units on a scale||Standard Deviation|Mean
2728223|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|summed symptom-score, range 0-21, with higher scores indicating greater severity.|baseline, 4 months|Intention-to-treat|||units on a scale||Standard Deviation|Mean
2728224|NCT01032239|Secondary|Healthcare Resource Utilization|Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6|baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6|Intent to treat analysis.|||Participants|||Count of Participants
2728225|NCT01032239|Secondary|Therapy Satisfaction|"Patients were presented with two statements (I am satisfied with the reduction in spasticity provided by my treatment, and I would recommend this therapy to a friend). They agreed, disagreed or were neutral with the statements."|month 6|Intent to treat analysis.|||Participants|||Count of Participants
2728226|NCT01032239|Secondary|Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6|"SS-QoL questionnaire is a self-assessed quality of life questionnaire specifically designed for post-stroke patients. It evaluates 49 items across 12-domains: personality, energy, language, mobility, vision, upper extremity function, thinking, mood, work/productivity, self-care, and family and social roles. Each item is rated on a 5-point Likert Scale, measuring either positive or negative response to a statement. Summary score is composed of an unweighted average of the 12 domain scores, with higher scores indicating better QoL. Total score ranges from 1 to 5. Change in SS-QoL summary score from baseline to month 6 between ITB and BMT arm was assessed.~Change=SS-QoL score at month 6 - SS-QoL score at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2728227|NCT01032239|Secondary|Change in SF-12 (12-item Short Form) From Baseline to Month 6|The SF-12 is generic assessment of health-related quality of life, which evaluates 8 health dimensions (physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health). Subscale scores for each dimension were aggregated into summary scores for physical (PCS) and mental health (MCS) components (ranging from 0 to 100, with higher scores indicating better health). Changes in the PCS and MCS from baseline to Month 6 were both compared between the BMT and ITB arms. Change=SF-12 score at month 6 - SF-12 score at baseline.|Baseline and month 6|"Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.~SF-12 assessment has been introduced later in a second version of the protocol, hence the lower number of patients."|||units on a scale||Standard Deviation|Mean
2728238|NCT01032200|Secondary|Fatigue|Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.|4 weeks post-RT|Participants with any data|||units on a scale||Standard Error|Least Squares Mean
2728239|NCT01032200|Primary|Adherence|Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)|4 weeks post-RT (approximately 3 months post randomization)|Participants who returned pill diaries|||percentage of ideal number of pills||Full Range|Mean
2728240|NCT01032200|Primary|Retention|Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.|4 weeks post-RT (approximately 3 months post randomization)|All randomized participants|||percentage of participants|||Number
2728228|NCT01032239|Secondary|Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6|"The EQ-5D-3L is a generic measure of health status consisting in the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/depression. Patients were asked to indicate their level of health on each dimension using one of three levels: no health problems, moderate health problems, and severe health problems. Responses from the questionnaire were converted to a single health index utility score; this ranges from -0.595 to 1. EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100 where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). Change in EQ-5D-3L utility score and VAS score from baseline to month 6 between ITB and BMT arm were assessed. Change=EQ-5D-3L utility or VAS score at month 6 - EQ-5D-3L utility or VAS score."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2728229|NCT01032239|Secondary|Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS)|GAS is designed to measure the achievement of treatment goals using the following 6 levels of achievement: worse than start (-3), much less than expected (-2), somewhat less than expected (-1), as expected (0), somewhat more than expected (+1), much more than expected (+2). The primary therapy goal and the criteria for the levels of achievement was defined by the medical team together with the patient and his/her family/legal representative/caregiver at the first day of the study. The number and percentage of patients who achieved the therapeutic goal at Month 6 was compared between the ITB and BMT arm.|month 6|Intent to treat analysis|||Participants|||Count of Participants
2728230|NCT01032239|Secondary|Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6|"NPRS is designed to assess the level of pain a patient is feeling at a point in time. The following questions has been presented to patients: What is your actual spasticity-related or spasm-related pain? What was your least spasticity-related or spasm-related pain during the last week? What was your worst spasticity-related or spasm-related pain during the last week? The patient indicated how much pain he is feeling on a scale from 0 to 10. A score of 0 (zero) is no pain while a score of 10 (ten) is worst possible pain. Change in NPRS related to actual, least or worst pain from baseline to month 6 between ITB and BMT arm was assessed. Change=NPRS at month 6 - NPRS at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2728231|NCT01032239|Secondary|Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance|Patient was asked to transfer from the wheelchair to bed without human assistance. High level functional patient (HLP) could transfer. Low level functional patient (LLP) was not able to transfer. Comparison of the number and percentage of HLP and LLP between ITB and BMT arms was evaluated.|baseline, month 3, month 6|Intent to treat analysis|||Participants|||Count of Participants
2728232|NCT01032239|Secondary|Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6|Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.Only High level functional patients (HLP) were analyzed. HLP were defined as patients able to transfer from the wheelchair to bed without human assistance.|||seconds||Standard Deviation|Mean
2728233|NCT01032239|Secondary|Change in Functional Independence Measure (FIM) Score From Baseline to Month 6|FIM contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Ratings should reflect actual observed performance, not capability. Total score ranges from 18 (lowest) to 126 (highest) level of independence. Change in FIM total score from baseline to month 6 between ITB and BMT arm was assessed. Change=FIM score at month 6 - FIM score at baseline.|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2728234|NCT01032239|Secondary|Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6|"AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the upper extremities were assessed: wrist flexors, elbow flexors, elbow extensors, shoulder abductors and shoulder adductors. Average AS was calculated as the average of AS scores of the 5 muscles of the affected lower extremities. Change in average AS in affected upper extremities from baseline to month 6 between ITB and BMT arm was assessed.~Change= AS at month 6 - AS at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2728235|NCT01032239|Primary|Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6|"AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed.~Change= AS at month 6 - AS at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2728236|NCT01032200|Secondary|HVLT-IR|HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.|4 weeks post-RT|Participants with any data|||number of correctly recalled words||Standard Error|Least Squares Mean
2728237|NCT01032200|Secondary|Sleepiness|Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.|4 weeks post-RT|Participants with any data|||units on a scale||Standard Error|Least Squares Mean
2731951|NCT01004354|Secondary|Changes in Serum Levels of C-reactive Protein.||Baseline and 8 weeks|Data were not collected for this analyte.||||||
2728243|NCT01032174|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.|Day 11|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. 'N' signifies number of participants with non-missing data. Missing observations were not imputed.|||Percentage of Participants|||Number
2728244|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728245|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728246|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728247|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728248|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728249|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728250|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728251|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728252|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 5 ( weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728253|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728254|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~* heavy drinking is defined as five or more drinks per day for men, four or more for women."|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728255|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~*heavy drinking is defined as five or more drinks per day for men, four or more for women"|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728256|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728396|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728257|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 5 (weeks 17 to 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728258|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728259|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728260|NCT01032135|Primary|Any Heavy Drinking Days|days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728261|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 6 (weeks 21 - 24)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728262|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, fromTime Line Follow Back|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728263|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728264|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728265|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
2728266|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728267|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 5 (weeks 16 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728268|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 4 (weeks 13 - 15 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728397|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2771078|NCT00731198|Secondary|Cannulation Time||Intra-procedure|||||||
2728269|NCT01032135|Primary|Any Drinking Days in Previous Month|Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728270|NCT01032135|Primary|Any Drinking Days in Previous Month|Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
2728271|NCT01032135|Primary|Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks|Number of treatment sessions attended|weeks 9 - 12||||treatment days||Standard Deviation|Mean
2728272|NCT01032135|Primary|Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks|Number of treatment sessions attended|weeks 9 - 12||||treatment days||Standard Deviation|Mean
2728273|NCT01032135|Primary|Treatment Engagement|Number of treatment sessions attended|weeks 3 - 12||||treatment days||Standard Deviation|Mean
2728274|NCT01032070|Secondary|Apparent Volume of Distribution (Vz/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||mL/m^2||95% Confidence Interval|Geometric Mean
2728275|NCT01032070|Secondary|Apparent Body Clearance (CL/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||mL/h/m^2||95% Confidence Interval|Geometric Mean
2728276|NCT01032070|Secondary|Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||hours||95% Confidence Interval|Geometric Mean
2728277|NCT01032070|Secondary|Maximum Observed Plasma Concentration of Erlotinib (Cmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||ng/mL||95% Confidence Interval|Geometric Mean
2728278|NCT01032070|Secondary|Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set (PKAS) consisted of the participants treated with erlotinib for whom sufficient analyte concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter. Participants may have been excluded from the PKAS for reasons such as missing data or protocol deviation.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2728279|NCT01032070|Secondary|Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. The relationship of each AE to study drug was assessed as either related or not related."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set).|||participants|||Number
2728280|NCT01032070|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.|From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.|The Full Analysis Set|||days||95% Confidence Interval|Median
2728281|NCT01032070|Secondary|Duration of Stable Disease|"Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD.~Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR, PR, MR or SD.|||days||95% Confidence Interval|Median
2733382|NCT00996333|Secondary|Toxicity Assessment|Data was not analyzed because original PI left institution before data analysis was completed.|Every month|||||||
2728282|NCT01032070|Secondary|Percentage of Participants With Prolonged Stable Disease|Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2728283|NCT01032070|Secondary|Progression Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first.~Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||days||95% Confidence Interval|Median
2728284|NCT01032070|Secondary|Percentage of Participants With Disease Control|"Disease control is a best overall response of CR or PR or MR or Stable disease (SD).~CR:~Complete disappearance of all enhancing tumor and mass effect~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks~If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively).~PR:~≥ 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks.~MR:~≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks.~SD:~Neurologic examination is at least stable~Maintenance corticosteroid dose is not increased~MRI meets neither the criteria for minor response nor for progressive disease~Sustained for ≥ 8 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2728285|NCT01032070|Secondary|Percentage of Participants With a Minor Response|"Participants with a best overall response of minor response (MR), defined as:~≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2728286|NCT01032070|Secondary|Duration of Response|"Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR.~Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR or PR.|||days||95% Confidence Interval|Median
2728287|NCT01032070|Primary|Percentage of Participants With an Objective Response|"Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks.~CR:~Complete disappearance of all enhancing tumor and mass effect~On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses)~Stable or improving neurologic examination sustained for ≥ 4 weeks~If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings).~PR:~≥ 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set (FAS) consisted of all randomized participants. Following the intent-to-treat (ITT) principle, participants were analyzed according to the treatment arm they were assigned to at randomization.|||percentage of participants||95% Confidence Interval|Number
2728288|NCT01032044|Primary|"Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated"|"Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of Optimally Treated, in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up."|3 month follow-up endoscopic procedure|Among the 141 patients who completed the initial procedure, 119 had follow-up visits.|||participants|||Number
2728289|NCT01032018|Primary|Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)||6 months after randomization||||dollars||Standard Error|Mean
2728316|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at Baseline|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.~Scale range (0-52):~A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 00 (baseline)||||units on a scale||Standard Deviation|Mean
2728290|NCT01032018|Primary|Depressive Symptom Reduction|Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.|Change from depression at baseline to depression at 6-months||||Scores on a scale||Standard Deviation|Mean
2728291|NCT01031979|Secondary|Change in Becks Depression Inventory (BDI-II) Score|The BDI-II is a 21-item self-report measure that assesses depressive behavioral symptoms. It has demonstrated adequate psychometric validity, and external validity and is used widely as the dependent variable in treatment outcomes research. The BDI-II produces score ranges from 0-63, with higher scores indicating more severe depression symptom severity. A 5-point decrease on the BDI-II is considered clinically significant.|0 weeks, 15 weeks||||units on a scale||Standard Deviation|Mean
2728292|NCT01031979|Secondary|Change in Post Traumatic Stress Disorder Checklist (PCL) Score|The PCL is a 17-item self-report measure of PTSD symptom severity based on the DSM-IV and has adequate psychometric properties. The PCL produces a score range between 17-85, with higher scores indicating more distress related to PTSD symptoms. A 10-point decrease on the PCL is considered clinically significant.|0 weeks, 15 weeks||||units on a scale||Standard Deviation|Mean
2728293|NCT01031979|Secondary|Change in Clinician Administered PTSD Scale (CAPS) Score|The CAPS is a structured interview for diagnosis of PTSD and is widely considered the gold-standard assessment. The CAPS produces a total score ranging from 0-136, with higher scores indicating more severe PTSD symptom severity. A 15-point decrease is considered clinically significant.|0 Weeks, 15 weeks||||units on a scale||Standard Deviation|Mean
2728294|NCT01031979|Primary|Trauma-Cued Heart Rate Reactivity|The primary outcome was trauma-cued heart rate reactivity a week after the drug visit as measured by the PTSD Brief Reactivity (PBR) task. For each patient, a 3-minute trauma script was constructed containing vivid details of the target trauma and used in tandem with a standard neutral script for baseline measurement. Heart rate reactivity for each time point was the beats per minute (BPM) difference between the neutral and trauma scripts represented as a slope.|One week after drug visit||||beats per minute||Standard Error|Mean
2728295|NCT01031953|Secondary|Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness|Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.|up to 24 hours after study drug administered.||||participants|||Number
2728296|NCT01031953|Secondary|Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant|Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).|up to 24 hours after study drug administered.||||participants|||Number
2728297|NCT01031953|Secondary|Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)|The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome|up to 24 hours after receiving fosaprepitant||||participants|||Number
2728298|NCT01031953|Secondary|Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)|Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief|2 hours after administration of Fosaprepitant 150 mg IV||||participants|||Number
2728299|NCT01031953|Secondary|Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours|Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.|Baseline to 24 hours after study drug administered.||||participants|||Number
2728300|NCT01031953|Secondary|Improvement in Nausea Score From 2 Hours to 24 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure."|2 hours to 24 hours after study drug administered.||||participants|||Number
2728301|NCT01031953|Secondary|Improvement in Nausea Score From Baseline to 12 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure."|Baseline to 12 hours after study drug administered.||||participants|||Number
2728317|NCT01031706|Secondary|FEV1 (Spirometry) Change|Absolute change in % predicted FEV1 between baseline and after 4 weeks of treatment calculated|Baseline and after 4 weeks of treatment|All available data included. Carry-forward of last FEV1 value (after 2 weeks of treatment) performed when data at 4 week time point not available|||Percentage of predicted FEV1||Standard Error|Mean
2730848|NCT01012167|Secondary|Vital Signs - Diastolic Blood Pressure|Mean diastolic blood pressure by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||mm-Hg||Standard Deviation|Mean
2728302|NCT01031953|Primary|Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure."|Baseline to 2 hours after study drug administered.||||participants|||Number
2728303|NCT01031914|Primary|Sleep/Wake Algorithm|We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.|The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.|All the participants completing the sleep study were included in the analysis|||accuracy (%)|||Number
2728304|NCT01031836|Primary|Number of Participants in Each Category of Adverse Events (AE) in Stage II||Stage II (1 year to 3.5 years after first dose)|Safety population|||Participants|||Count of Participants
2728305|NCT01031836|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I||Stage I|Safety population|||Participants|||Count of Participants
2728306|NCT01031836|Secondary|Change From Baseline in 21-gene Signature Fold Change in Stage I|21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.|Stage I|Safety population|||fold change||Standard Deviation|Mean
2728307|NCT01031836|Secondary|Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I||After first dose in Stage I|PK populaton|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2728308|NCT01031836|Primary|Number of Participants With Each Category of Adverse Events in Stage I||Stage I (up to 1 year)|Safety population|||Participants|||Count of Participants
2728309|NCT01031836|Secondary|AUC0-14 of MEDI-545 After First Dose in Stage I|Summary of area under the concentration-time curve from zero to Day 14.|After first dose in Stage I|PK populaton|||day*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2728310|NCT01031836|Secondary|Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I||After first dose in Stage I (0 upto 28 days)|Pharmacokinetics (PK) populaton|||day*ug/mL||Full Range|Median
2728311|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at week12|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.~Scale range (0-52):~A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 12||||Score on a scale||Standard Deviation|Mean
2728312|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 16||||units on a scale||Standard Deviation|Mean
2728313|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 12||||units on a scale||Standard Deviation|Mean
2728314|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 04||||units on a scale||Standard Deviation|Mean
2728315|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Weeks 00||||units on a scale||Standard Deviation|Mean
2729721|NCT01020123|Secondary|Diastolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 240 in CSR)|||mmHg||Standard Deviation|Mean
2728319|NCT01031680|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full analysis set; participants with baseline BMI ≥27 kg/m² and Week 24 (LOCF) body weight value|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2728320|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
2728321|NCT01031680|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
2728322|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, participants with non-missing baseline and Week 8 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
2728323|NCT01031680|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Number
2728324|NCT01031680|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
2728325|NCT01031628|Primary|Evaluation of Lesions for Progression or Response Via RECIST Criteria||Every 3 months|Data were not collected or analyzed due to early termination.||||||
2728326|NCT01031550|Secondary|Decrease in Liver Lipid Peroxidation and Apoptosis||first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
2728327|NCT01031550|Secondary|Length of ICU and Hospital Stay||first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
2728328|NCT01031550|Secondary|Peak Postoperative AST, ALT and T Bili||first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
2728329|NCT01031550|Primary|Post Operative Complications Grade IIIb or Greater According to Clavien's Classification Which is a Classification System Used to Grade Surgical Complications|Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.|first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
2728330|NCT01031537|Primary|TBEV Viral Neutralization Titer >1:10|The number of participants that develop anti-tick borne encephalitis antibody viral neutralization titer levels (>1:10) following receipt of 3 doses of intramuscular FSME-IMMUN (vaccine series)|6 months|Six participants had protective antibody levels (>1:10) reflective of either prior successful immunization or infection at baseline and were not evaluated at the 6 month time point. One participant withdrew from the study prior to the 6 month evaluation time point.|||Participants|||Count of Participants
2728331|NCT01031537|Primary|TBEV Viral Neutralization Titer >1:10|Tick borne encephalitis antibody viral neutralization titer levels (>1:10)|Baseline|Baseline TBEV protective antibody levels (>1:10) reflective of either prior successful immunization or infection at baseline|||Participants|||Count of Participants
2728332|NCT01031498|Primary|Number of Patients With Complete Response|Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.|7 days, starting first day of chemotherapy|Analysis was per protocol. Seven patients were excluded from the efficacy analysis.|||participants|||Number
2728333|NCT01031446|Secondary|Time to Progression in Patients With Metastatic Basal-like Breast Cancer.|Median duration in months from on-study to disease progression in patients with metastatic basal-like breast cancer. All patients with basal-like breast cancer are negative for estrogen, progesterone, and human epidermal growth factor (HER2) receptors.|Up to 64 weeks|Patients who are negative for estrogen, progesterone and HER2 receptors. Time to progression was not determined for 5 patients in this group: toxicity (2), withdrew after beginning treatment (1), no progression (1), and on-treatment (1).|||months||Full Range|Median
2728334|NCT01031446|Primary|Patients With Progression-free Survival|Patients who had not experienced disease progression and who were alive at 6 months after study entry|at 6 months|Patient who received the study drugs. Four patients were not available for measurement of progression at 6 months: toxicity (3), withdrew after beginning treatment (1)|||participants|||Number
2728335|NCT01031446|Secondary|Time to Progression|Duration in months from date on-study to date patient exhibited progressive disease|Up to 64 weeks|Patients who were available for determination of duration of time to progressive disease. Time to progression is unknown for 8 Phase II patients due to: on-treatment (1), toxicity (3), withdrew after beginning treatment (1), and no progression (3)|||months||Full Range|Median
2728336|NCT01031446|Secondary|Patients With Overall Response|Per Response Evaluation Criteria in Solid Tumor (RECIST) criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 12 weeks|Patients for whom an overall response could be measured. Four patients were not evaluable due to: withdrew after beginning treatment (1) and not evaluable due to only 1 cycle of treatment (3).|||participants|||Number
2728337|NCT01031446|Primary|Maximum Feasible Dose in mg of RAD001 (Everolimus)for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per day in Phase I that allows for safe and feasible administration the medication. The MTD is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy|at 8 weeks|Patients enrolled to determine the safety profile and recommended dose of cisplatin + RAD001 + paclitaxel in women with metastatic breast cancer|||mg|||Number
2728338|NCT01031446|Primary|Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.|at 8 weeks|Patients enrolled to determine the safety profile and recommended doses of cisplatin + paclitaxel + everolimus (RAD001) in women with metastatic breast cancer|||mg/m2|||Number
2728339|NCT01031420|Secondary|Toxicity Profile of Dose Dense MVAC Given in the Neoadjuvant Setting.|Defined by number of patients who complete all three cycles of treatment without dose reduction|Ongoing throughout treatment at each MD visit every 14 days.|Forty patients were evaluable for response as predefined in the protocol.|||participants|||Number
2728340|NCT01031420|Primary|Percentage of Participants With Complete Response at Cystectomy or Ureterectomy Following Preoperative Dose Dense MVAC|complete response rate (pT0), as defined by pathologic staging at cystectomy or ureterectomy, following neoadjuvant DD-MVAC chemotherapy.|Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response.||||percentage of total participants||95% Confidence Interval|Number
2728341|NCT01031381|Secondary|Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)|The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Within 4 weeks (28 days) of study treatment initiation (baseline)|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks|||participants|||Number
2728342|NCT01031381|Primary|Progression-free Survival (PFS) at 6-months|The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Up to 36 months (data collection period for the cohort); Up to 6 months for participant|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days|||percentage of participants||95% Confidence Interval|Number
2728343|NCT01031134|Secondary|Change in Hamilton Depression Rating Scale Scores|Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.|Baseline and 12 week|fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome|||units on a scale||Standard Deviation|Mean
2728344|NCT01031134|Primary|Number of Participants Who Adhered to Physician Recommended Treatment|Any mental health service use over 12 weeks.|12 weeks||||Participants|||Count of Participants
2728345|NCT01031095|Primary|Major Adverse Cardiac Event||30 days||||percentage of event|||Number
2728346|NCT01031095|Primary|Major Adverse Cardiac Events||30 days||||percentage of event|||Number
2728347|NCT01031069|Secondary|Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response|The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).|At Day 0, Week 6, Week 10, Month 7 and Month 12|The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-) who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.|||CD4 cells/million T-cells||Inter-Quartile Range|Median
2728348|NCT01031069|Secondary|Frequency of Specific B-cells for HPV-16/18 Antigens|B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).|At Day 0, Week 6, Week 10, Month 7 and Month 12|The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-),who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.|||B-cells/million cells||Inter-Quartile Range|Median
2728349|NCT01031069|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)|Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.|At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included post-menarcheal subjects who volunteered for this procedure, met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2728350|NCT01031069|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum|Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.|At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2728351|NCT01031069|Secondary|Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC|"Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], for HIV- subjects.~Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline)."|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.|||Titers||95% Confidence Interval|Geometric Mean
2728352|NCT01031069|Secondary|Number of HIV+ Subjects by WHO HIV Clinical Staging|HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification [WHO, 2009].|At Months 12, 18 and 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.|||Participants|||Count of Participants
2728353|NCT01031069|Secondary|HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24|HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.|At Months 12, 18 and 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.|||HIV copies/mL||Inter-Quartile Range|Median
2728354|NCT01031069|Secondary|Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24|CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.|At Months 12, 18 and 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.|||cells/mm3||Inter-Quartile Range|Median
2728355|NCT01031069|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728356|NCT01031069|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.|From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728357|NCT01031069|Secondary|Number of Subjects With SAEs|SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 up to Month 24)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728358|NCT01031069|Secondary|Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters|Among assessed haematological parameters were: neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7*, Month 12, Month 18 and Month 24.~* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure."|||Participants|||Count of Participants
2728367|NCT01031069|Secondary|Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).|During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.|||Participants|||Count of Participants
2728359|NCT01031069|Secondary|Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters|Among assessed haematological parameters were: haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP] and monocytes [MONO]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7*, Month 12, Month 18 and Month 24.~* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure."|||Participants|||Count of Participants
2728360|NCT01031069|Secondary|Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters|Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophils [BSPH], creatinine [CRT], eosinophils [ESPH]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7*, Month 12, Month 18 and Month 24.~* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure."|||Participants|||Count of Participants
2728361|NCT01031069|Secondary|Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies|Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.|During the entire study period (from Day 0 up to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2728362|NCT01031069|Secondary|Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)|Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728363|NCT01031069|Secondary|Number of HIV- Subjects With Medically Significant Conditions (MSCs)|Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728364|NCT01031069|Secondary|Number of HIV- Subjects With Serious Adverse Events (SAEs)|SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728365|NCT01031069|Secondary|Number of HIV- Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728366|NCT01031069|Secondary|Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, rash, temperature [defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.|||Participants|||Count of Participants
2728394|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2730894|NCT01011868|Secondary|Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment|Change from baseline in body weight after 18, 54 and 78 weeks of treatment|Baseline, 18, 54, 78 weeks|FAS (OC)|||kg||Standard Error|Mean
2728368|NCT01031069|Primary|Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)|"Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects.~Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline)."|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.|||Titers||95% Confidence Interval|Geometric Mean
2728369|NCT01031069|Primary|Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity|"Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects.~Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline)."|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom Month 7 data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity at Month 7 were available.|||Titers||95% Confidence Interval|Geometric Mean
2728370|NCT01031069|Primary|Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging|HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification [WHO, 2009].|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.|||Participants|||Count of Participants
2728371|NCT01031069|Primary|HIV Viral Load (VL) in HIV+ Subjects at Month 7|HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.|||HIV copies/mL||Inter-Quartile Range|Median
2728372|NCT01031069|Primary|Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7|CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.|||cells/mm3||Inter-Quartile Range|Median
2728373|NCT01031069|Primary|Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities|Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophilis [BSPH], creatinine [CRT], eosinophils [ESPH], haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP], monocytes [MONO], neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|At Month 7 (30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.|||Participants|||Count of Participants
2728374|NCT01031069|Primary|Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies|Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2728375|NCT01031069|Primary|Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728376|NCT01031069|Primary|Number of HIV+ Subjects With Medically Significant Conditions (MSCs)|Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728377|NCT01031069|Primary|Number of HIV+ Subjects With Serious Adverse Events (SAEs)|SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728395|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2743529|NCT00927784|Primary|Incidence of Infectious Myocarditis||Measured within 90 days of study entry||||participants|||Number
2728378|NCT01031069|Primary|Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination|The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2728379|NCT01031069|Primary|Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, rash, temperature [defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.|||Participants|||Count of Participants
2728380|NCT01031069|Primary|Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).|During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.|||Participants|||Count of Participants
2728381|NCT01031043|Primary|Distal Contractile Integral|The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg *s*cm to >10,000 mmHg *s*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction.|Encounter 1 (day 1) and Encounter 2 (Month 14)|All subjects enrolled in the study|||mmHg*s*cm||Standard Deviation|Mean
2728382|NCT01031004|Primary|Average Wear Time||after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||hours per day||Standard Deviation|Mean
2728383|NCT01031004|Primary|Average Wear Time||after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||hours per day||Standard Deviation|Mean
2728384|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.|after 1 month|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728385|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.|after 1 week|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728386|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728387|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728388|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728389|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728390|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728391|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728392|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728393|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728399|NCT01031004|Primary|Slit Lamp Findings - Corneal Edema|Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
2728400|NCT01030965|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28|Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.|Baseline, Day 1, and Day 28|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2728401|NCT01030965|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline, Day 1, and Day 28|ITT Population. Participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.|||Liters||Standard Error|Least Squares Mean
2728402|NCT01030965|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline and Day 29|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.|||Liters||Standard Error|Least Squares Mean
2728403|NCT01030952|Secondary|Change in Percent of 24 Hour Hyperglycemic Measurements|Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.|||percent of measurements||Standard Deviation|Mean
2728404|NCT01030952|Secondary|The Percent of 24 Hour Hypoglycemic Measurements|Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent-to-treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. During different time points, participants with observations at that time point were included in the analysis|||percent of measurements||Standard Deviation|Mean
2728405|NCT01030952|Secondary|Change in Mean Amplitude of Glycaemic Excursion (MAGE)|mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||mmol/l||Standard Deviation|Mean
2728406|NCT01030952|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 3. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
2728407|NCT01030952|Secondary|Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint|TG change in blood lipids level from baseline to endpoint|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
2728636|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 12 months after drug administration|Safety population|||Participants|||Number
2728408|NCT01030952|Secondary|Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point|time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
2728409|NCT01030952|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|change in LDL-C at 0, 30 and 120 minutes|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
2728410|NCT01030952|Secondary|Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline|This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.|||(μU/ml)||Standard Deviation|Mean
2728411|NCT01030952|Secondary|Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment|GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||percent||Standard Deviation|Mean
2728412|NCT01030952|Secondary|Changes in 24 Hour Glucose Area Under Curve (AUCpp)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|baseline, end of study (3 weeks)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol*min/L||Standard Deviation|Mean
2728413|NCT01030952|Secondary|Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)|The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability.|baseline, 3 weeks (end of study)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
2728414|NCT01030952|Secondary|Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.|Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline|||mmol/l||Standard Deviation|Mean
2728415|NCT01030952|Secondary|Change in Mean Blood Glucose (MBG)|The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately.|baseline and at 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline|||millimoles per litre (mmol/l)||Standard Deviation|Mean
2728416|NCT01030952|Secondary|Change in Incremental Glucose Peak (IGP) From Baseline|Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.|||millimoles per litre (mmol/L)||Standard Deviation|Mean
2728417|NCT01030952|Primary|Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)|"The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.~0-4 hours AUC were calculated using trapezoid methods."|3 weeks (end of study) minus baseline|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.|||millimoles hours per litre (mmol*hr/L)||95% Confidence Interval|Least Squares Mean
2728418|NCT01030822|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life- threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|After the first vaccination up to study end (from Month 0 to Month 15)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2728419|NCT01030822|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31-day follow-up period (Days 0-30) after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2728446|NCT01030718|Secondary|Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling|Blood samples for pharmacokinetic analysis of Dasatinib BID that will contribute to population pharmacokinetic modeling were collected.|At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose|There was no individual PK analysis done for this study; analyses were integrated and evaluated as a part of population PK of this drug.|||participants|||Number
2728420|NCT01030822|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2728421|NCT01030822|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2728422|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728423|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728424|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Persistence)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728425|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
2728426|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
2728427|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence)|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2733383|NCT00996333|Secondary|Determine Overall and One Year Survival Rates|Data was not analyzed because original PI left institution before data analysis was completed.|One year|||||||
2728428|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2728429|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Antibodies assessed for this outcome measure were those against the cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2728430|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence)|Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||µg/mL||95% Confidence Interval|Geometric Mean
2728431|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
2728432|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
2728433|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence)|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2728434|NCT01030822|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence)|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB+Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||µg/mL||95% Confidence Interval|Geometric Mean
2728447|NCT01030718|Secondary|Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)|Point mutations of BCR-ABL detected or undetected in the Quantitative real-time PCR polymerase chain reaction (RQ-PCR) products|At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.|Treated participants|||participants|||Number
2728435|NCT01030822|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2728436|NCT01030822|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points. Primary results are results one month after booster vaccination (Month 1).|||µg/mL||95% Confidence Interval|Geometric Mean
2728437|NCT01030783|Secondary|Pharmacokinetics (Serum Concentrations) of Tivozanib|Samples for tivozanib serum concentrations will be collected at the following time points: Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28. The serum concentrations of tivozanib were tabulated for individual subjects and summarized by nominal time using standard descriptive statistics (concentrations presented in ng/mL).|Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28|All patients who had taken at least 1 dose of tivozanib and who had at least one measurable concentration value.|||ng/mL||95% Confidence Interval|Mean
2728438|NCT01030783|Secondary|To Compare Kidney-specific Symptoms and Health Outcome Measurements in Subjects Randomized to Treatment With Tivozanib or Sorafenib|The Disease Related Symptom Scale of the Functional Assessment of Cancer Therapy - Advanced Kidney Cancer Symptom Index (FKSI-DRS) measured kidney specific symptoms on a 0-36 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. The Functional Assessment of Cancer Therapy-General (FACT-G) measured general wellbeing scored on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. The European Quality of Life-5 Dimensions (EQ-5D) measured patient health related quality of life scored on a 0-1 scale, with 0 being worse health state and 1 being perfect health state. The European Quality of Life-5 Dimensions Visual Analog Scales (EQ-5D VAS) measured patient health related quality of life on a visual analog scale from 0 to 100, with 0 being the worst and 100 being the best. These scales were self-administered by patients at the start of the visit.|At Day 1 of each 28 day cycle throughout the course of the study, for an average of 11 months per subject|ITT Population, excluding questionnaires that were not analyzable|||Score on a scale||Standard Error|Least Squares Mean
2728439|NCT01030783|Secondary|Safety and Tolerability of Tivozanib and Sorafenib|Dose reductions and interruptions were allowed for subjects taking tivozanib or sorafenib. Any modification of study drug administration, and the reason for such action, was clearly noted on the subject's eCRF.|From start of treatment therapy to completion of treatment therapy, an average of 11 months|Safety Population|||Participants|||Count of Participants
2728440|NCT01030783|Secondary|Duration of Response (DR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib|Duration of response (DR) is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.0 or to death due to any cause.|Assessed every 8 weeks from date of randomization until date of progression|ITT Population|||Months||95% Confidence Interval|Median
2728441|NCT01030783|Secondary|Objective Response Rate (ORR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib|Objective response rate (ORR) is defined as the percentage of subjects who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.0).|Every 8 weeks from date of randomization until disease progression|ITT Population|||percentage of participants||95% Confidence Interval|Number
2728442|NCT01030783|Secondary|Overall Survival (OS) of Subjects Randomized to Treatment With Tivozanib or Sorafenib|Overall survival (OS) is defined as the time from the date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive. Subjects lacking data beyond randomization will have their survival times censored on the date of randomization.|Date of randomization to date of death|ITT Population|||Months||95% Confidence Interval|Median
2728443|NCT01030783|Primary|Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib|Progression-Free Survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.0 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.|ITT Population|||Months||95% Confidence Interval|Median
2728444|NCT01030757|Secondary|Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.||1 year|Study was terminated due to low accrual; no results to report.||||||
2728445|NCT01030757|Primary|Tumor Response Rate (Complete Response + Partial Response).||1 year|Study was terminated due to low accrual; no results to report||||||
2728448|NCT01030718|Secondary|Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement|Detectable BCR-ABL transcripts (b3a2, b2a2 or minor) >=2.0 log copy/micrograms RNA, as measured by real-time quantitative PCR (RQ-PCR) at baseline and best achievement post-dose.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation|Treated participants|||participants|||Number
2728449|NCT01030718|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of OHR was computed only for participants whose best response was CHR or a MaHR or MiHR & was measured from the first day hematologic response criteria were met, provided they were confirmed 28 days later until the date of PD or death. Median duration of OHR in the CML-AP/BP arm was not yet reached.|||Days||Full Range|Median
2728450|NCT01030718|Secondary|Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Time to OHR = time from first dose of dasatinib until the first day measurement criteria are first met for hematologic response provided they were confirmed 28 days later. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|OHR was computed only for subjects whose best response is CHR or MaHR or Minor HR (MiHR).|||Days||Full Range|Median
2728451|NCT01030718|Secondary|Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response (MaHR)=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of MaHR was computed only for advanced diseases subjects whose best response is a MaHR and was measured from the first day MaHR criteria are met, provided they were confirmed 28 days later until the date of PD or death. Median Duration of MaHR was not yet reached in the CML-AP/BP arm.|||Days||Full Range|Median
2728452|NCT01030718|Secondary|Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Time to major hematologic response (MaHR)=time from first dose of dasatinib until the first day the measurement criteria for MaHR and is computed only for advanced diseases subjects whose best response is a major hematologic response. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving MaHR|||Days||Full Range|Median
2728453|NCT01030718|Secondary|Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|Duration of CHR was computed only for chronic phase CML subjects whose best response is CHR. It was measured from the first day complete hematologic response criteria are met provided they are confirmed 28 days later until the date treatment is discontinued due to PD or death. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR. Duration of CHR in the CML AP/BP arm has not yet been reached.|||Days||Full Range|Median
2728454|NCT01030718|Secondary|Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|CHR=all of the following criteria: WBC ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. Time to CHR=time from first dose of dasatinib until the first day criteria for CHR are met provided they are confirmed 28 days later and was computed only for chronic phase CML subjects whose best response is CHR. Subjects who neither progressed nor died were censored at date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR|||Days||Full Range|Median
2728455|NCT01030718|Secondary|Participants With Ph+ ALL: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=(see Outcome Measure 14, above). NEL=WBC ≤ULN; BM blasts ≤5%; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; <20% peripheral blood basophils; no extramedullary involvement; and at least 1 of the following: ANC ≥500/mm3 and <2000/mm3 or platelets ≥20,000/mm3 and <100,000/mm3. Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated Ph+ ALL participants|||Percentage of Participants||95% Confidence Interval|Number
2728456|NCT01030718|Secondary|Participants With CML-AP/BP: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=WBC <ULN; absolute neutrophil count (ANC) >1,000/mm3; platelets >100,000/mm3; no blasts or promyelocytes in peripheral blood; BM blasts ≤5%; <5% myelocytes + metamyelocytes in peripheral blood; <20% basophils in peripheral blood; no extramedullary involvement. NEL=(see Outcome Measure 15, below). Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-AP/BP participants|||Percentage of Participants||95% Confidence Interval|Number
2729722|NCT01020123|Secondary|Systolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 237 in CSR)|||mmHg||Standard Deviation|Mean
2728457|NCT01030718|Secondary|Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count (WBC) ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-CP participants|||Percentage of Participants||95% Confidence Interval|Number
2728458|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-AP/BP arm.|||Days||Full Range|Median
2728459|NCT01030718|Secondary|Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-CP arm.|||Days||Full Range|Median
2728460|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.|||Days||Full Range|Median
2728461|NCT01030718|Secondary|Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.|||Days||Full Range|Median
2728462|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group.|||Days||Full Range|Median
2728463|NCT01030718|Secondary|Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group.|||Days||Full Range|Median
2728464|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR|||Days||Full Range|Median
2728465|NCT01030718|Secondary|Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),|Participants achieving CCyR|||Days||Full Range|Median
2728466|NCT01030718|Secondary|Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated Ph+ ALL participants|||Percentage of Participants||95% Confidence Interval|Number
2728637|NCT01029340|Secondary|Part A - Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 6 weeks after first injection of study drug|Safety population|||Participants|||Number
2728467|NCT01030718|Secondary|Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated CML-AP/BP participants|||Percentage of Participants||95% Confidence Interval|Number
2728468|NCT01030718|Secondary|Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive [Ph+] Cells in Metaphase in BM).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Treated CML-CP participants|||Percentage of Participants||95% Confidence Interval|Number
2728469|NCT01030718|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation|All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF.|||participants|||Number
2728470|NCT01030666|Secondary|Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD])|If the CEJ was destroyed by the restorative treatment the margin of the restoration was taken as landmark. BD is defined as most coronal point where the periodontal ligament space shows a continuous width. If no periodontal ligament space could be identified, the point where the projection of the alveolar crest (AC) crossed the root surface was taken as a landmark. If both structures could be identified at one defect, the point defined by the periodontal ligament was used as BD and the crossing of the silhouette of the alveolar crest with the root surface was defined as AC. If several bony contours could be identified, the most apical one that crossed the root was defined as the BD and the most coronal one as AC.|Baseline to 12 months after surgery|ITT population. Missing data due to losing to follow-up: last observation carried forward. Patients whose radiographs could not be analysed were excluded.|||mm||Standard Deviation|Mean
2728471|NCT01030666|Primary|Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery|Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.|Baseline to 6 months after surgery|per protocol analysis: all participants who attended the 6 months re-examination|||mm||Standard Deviation|Mean
2728472|NCT01030653|Secondary|The Area Under the Curve Over the Dosing Interval for All Participants While on the High Dose and Low Dose Interventions.||12 hours||||hour*milligram/Liter||95% Confidence Interval|Geometric Mean
2728473|NCT01030653|Primary|Geometric Mean Ratio of the AUC Between the High and Low Dose Voriconazole|AUC is the area under the concentration-time curve. The Geometric Mean Ratio and 90% confidence interval around this value permit an assessment of the bioequivalence of two dosing regimens in the same group. The geometric mean is computed based on the ratio of the AUC value from the high dose compared to the AUC value from the low dose for each individual. This ratio provides a more robust interpretation of the differences between the two dosing arms because each individual serves as their own control.|14 days|This is a comparison of the same group analyzed through a cross-over design of two voriconazole dosing regimens|||Ratio||90% Confidence Interval|Number
2728474|NCT01030653|Primary|Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens|"Cmax is the maximum concentration, and Cmin is the minimum concentration. These measurements are based on analysis of plasma. The units shown are milligrams of voriconazole per liter of plasma. The two dosing regimens are:~a loading dose (400 mg x 2 doses, day 1) and maintenance doses (200 mg every 12 hours x 7 doses) in obese subjects.~a loading dose (400 mg x 2 doses, day 1) and maintenance doses (300 mg every 12 hours x 7 doses) in obese subjects."|Day 5|The same subjects were analyzed in a cross-over design at two dose levels|||mg/L||95% Confidence Interval|Mean
2728475|NCT01030536|Secondary|Percentage of Participants With Stable Disease (SD)||Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
2728476|NCT01030536|Secondary|Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs)|The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
2728680|NCT01028911|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||hours||Full Range|Median
2728477|NCT01030536|Secondary|Number of Participants With CD22 Expression Levels|CD22 Expression was analyzed using Prism® analysis. Flow cytometry was performed to quantitate the CD22 expression for the purpose of evaluating the relationship of CD22 expression with response to treatment.|Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)|Evaluable population for expression of CD22 on malignant cells included all participants with peripheral blood samples containing 10 or more B cells (CD19-positive cells) per cubic millimeter.|||Participants|||Count of Participants
2728478|NCT01030536|Secondary|Number of Participants With Positive Anti-Drug Antibody|The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA).|Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
2728479|NCT01030536|Secondary|Elimination Half Life (t1/2) of Moxetumomab Pasudotox|Plasma decay half life is the time measured for the plasma concentration to decrease by one half.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||hour||Standard Deviation|Mean
2728480|NCT01030536|Secondary|Clearance (CL) of Moxetumomab Pasudotox|CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||milliliter per hour per kilogram||Standard Deviation|Mean
2728481|NCT01030536|Secondary|Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox|Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2728482|NCT01030536|Secondary|Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox|Maximum observed drug concentration of Moxetumomab pasudotox in plasma.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2728483|NCT01030536|Secondary|Duration of Stable Disease (SD)|Duration of SD was defined as the time period from start of moxetumomab pasudotox administration to the event of progressive disease (PD)/relapse. Duration of SD was only calculated for the subgroup of participants with best response of CR, PR, or SD, and was calculated using the Kaplan-Meier method.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
2728484|NCT01030536|Secondary|Duration of Objective Response (DOR)|DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
2728485|NCT01030536|Secondary|Time to Response (TTR)|TTR was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was only assessed in participants who had achieved objective response (OR).|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
2728486|NCT01030536|Secondary|Percentage of Participants With Objective Response (OR)|OR was defined as the percentage of participants with CR or partial response (PR).|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
2728487|NCT01030536|Secondary|Percentage of Participants With Partial Response (PR)||Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
2728488|NCT01030536|Secondary|Duration of Complete Response|Duration of CR was measured from the first documentation of a CR to the time of relapse for the subgroup of participants with CR. Duration of CR was calculated using the Kaplan Meier method. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
2729724|NCT01020123|Secondary|Triglycerides: Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 226 in CSR)|||mg/dL||Standard Deviation|Mean
2728489|NCT01030536|Secondary|Percentage of Participants With Complete Response (CR)|The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
2728490|NCT01030536|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
2728491|NCT01030536|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
2728492|NCT01030536|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
2728493|NCT01030536|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
2728494|NCT01030536|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Any Grade 3 or greater, non-hematological toxicity (including capillary leak syndrome [CLS] and thrombotic microangiopathy/ hemolytic uremic syndrome (HUS), Grade 3 or higher treatment-related hematologic toxicities and only ≥ Grade 3 thrombotic microangiopathy /HUS constituted a DLT with few exceptions.|Day 1 to end of Cycle 1 (approximately 28 days)|Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.|||Participants|||Count of Participants
2728495|NCT01030536|Primary|Maximum Tolerated Dose (MTD)|MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity [DLT]) in more than 30 percent (%) of participants.|Day 1 to end of Cycle 1 (approximately 28 days)|Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.|||mcg/Kg|||Number
2728496|NCT01030458|Secondary|Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up|This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)|6 months follow-up after randomization||||participants|||Number
2728497|NCT01030458|Secondary|Side-effects to Study Medications||6 months follow-up after randomization||||participants|||Number
2728498|NCT01030458|Secondary|Time to Blood Pressure Control|The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.|6 months follow-up after randomization||||weeks||Inter-Quartile Range|Median
2728499|NCT01030458|Primary|Sitting Systolic Blood Pressure on Automated Measurement|Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.|6 months follow-up after randomization|The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.|||mmHg||Standard Deviation|Mean
2728754|NCT01028222|Secondary|OS Rate|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Percentage of participants|||Number
2728500|NCT01030406|Primary|Drug Liking at .5 Hours|"Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question Do you dislike or like the drug effect you are feeling now? and anchored in the center with Neither like nor dislike (score of 50), on the left with Dislike an awful lot (score of 0) and on the right with Like an awful lot (score of 100)."|Measure collected at 0.5 hours post-dose|Per protocol completers|||score on a scale||Standard Deviation|Mean
2728501|NCT01030341|Secondary|Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score|"To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis as assessed by GCSI total score and mean score and quality of life as assessed by PAGI-QOL score in diabetics with gastroparesis.~The outcome is assessed using the self-reported total GCSI score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item postprandial fullness/early satiety subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5.~The self-reported PAGI-QOL total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected in the last 2 weeks.The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks."|Change from baseline (screening) vs 24 weeks of follow-up||||score on a scale||Standard Deviation|Mean
2728502|NCT01030341|Primary|Hypoglycemic Episodes|The incidence rate (events / person-week) of mild/moderate (glucose level < 70 mg/dL) and severe (glucose < 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy.|4 weeks screening vs 24 weeks follow-up|44 patients had non-missing data during screening phase and 37 had non-missing data during treatment phase|||event rate per person-week|||Number
2728503|NCT01030289|Secondary|Confidence Ratings in Guessing of Treatment Condition|"At the end of the participants' second appointment, they were asked to guess which tDCS session was real and which was sham. 0=completely guessing. 10=absolutely sure. We calculated how many participants correctly guessed when they received real and when they received sham. A composite index was created to control for correct-guessing in the mixed model analysis. A new variable was created wherein the guess correct value (0=incorrect guess, 1=correct guess) was multiplied by the guess confidence rating for each participant. Thus, those that guess incorrectly had a guess-composite value of 0 whereas those that guessed correctly had a value equal to their guess confidence."|After treatment||||units on a scale||Standard Deviation|Mean
2728504|NCT01030289|Secondary|Food Ingested and tDCS Condition|"Food was presented on a plate for the participants to eat after treatment. Each participant received a Chocolate Plate, Donut Plate, Cookie Plate, and a Potatoe Chip Plate. Each participant received the same amount of food on each plate. Each plate was weighed in grams separately before and after eating the food. A difference score was calculated to determine how much food was eaten for each type of food.~The mean difference score was calculated for each type of food for the Sham tDCS group & the Real tDCS group. The means and standard deviations of percent change in the decrease of food (weighed in grams) ingested post-tDCS treatment are reported below for the real tDCS group and the sham tDCS group."|After treatment||||percent change in grams of food ingested||Standard Deviation|Mean
2728505|NCT01030289|Secondary|Inability to Resist Food and tDCS Condition|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before, during, and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings, completely resist food) to 100 (extreme food cravings, unable to resist food).~The before treatment, during treatment, and after treatment resist ratings for carbohydrates were used to calculate percent change."|before treatment, during treatment, after treatment||||percentage of change in resist ratings||Standard Deviation|Mean
2728506|NCT01030289|Secondary|Cravings for Carbohydrate Foods|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment, during, and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings) to 100 (extreme food cravings).~The before treatment, during treatment, and after treatment ratings for carbohydrates were used to calculate percent change."|before treatment, during treatment, after treatment||||percentage of change in cravings||Standard Deviation|Mean
2728507|NCT01030289|Secondary|Cravings for Sweet Foods|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment and after real tDCS and Sham tDCS. The scale ranged from 0 (no sweet food cravings) to 100 (extreme sweet food cravings).~The before treatment after treatment ratings for sweet food craving were used to calculate percent change."|before treatment, after treatment||||percentage of change in cravings||Standard Deviation|Mean
2728508|NCT01030289|Primary|Food Cravings|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings) to 100 (extreme food cravings).~The before treatment after treatment food craving ratings were used to calculate percent change."|before treatment, after treatment||||percentage of change in cravings||Standard Deviation|Mean
2730110|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.|Lack of recall of picture shown indicates presence of amnesia the day following surgery.|One day after surgery|Per protocol|||percentage of patients|||Number
2728509|NCT01030133|Secondary|Confidence Ratings of Guessing TMS Condition Assignment|"After participants guessed their TMS condition; whether they received real or sham TMS, They were then asked to rate the confidence in their guess. Ratings were on a scale of 0-10 where 0=complete guess and 10=absolutely sure.~Results below include the mean confidence ratings of those that guessed the TMS condition correctly and those that guessed incorrectly."|After Pain Control Paradigm||||units on a scale||Standard Deviation|Mean
2728510|NCT01030133|Secondary|Number of Participants That Correctly Guessed Their TMS Condition Assignment|"After each participant completed the experiment, they guessed their TMS Condition, whether they received real or sham TMS.~Results below report the number of participants in each group that guessed their TMS condition correctly."|After Pain Control Paradigm||||Participants|||Count of Participants
2728511|NCT01030133|Primary|Pain Intensity During Perceived Control Condition|The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials.), participants in the operator role group rated the pain intensity of each thermal stimulus on a computerized visual analog scale (VAS). Pain intensity ratings are on a scale of 0 to 100. 0=not painful. 100=extremely painful. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean pain intensity rating for both groups during the perceived control condition.|30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS||||units on a scale||95% Confidence Interval|Mean
2728512|NCT01030133|Primary|Pain Unpleasantness During Perceived Control Condition|The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials. Participants in the operator role group rated the unpleasantness of each thermal stimulus on a computerized visual analog scale (VAS). Unpleasantness ratings are on a scale of 0 to 100. 0=not unpleasant. 100=extremely unpleasant. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean unpleasantness rating for both groups during the perceived control condition.|30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS||||units on a scale||95% Confidence Interval|Mean
2728513|NCT01029925|Primary|Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|upto 72 days|Intent to treat analysis was performed. Zero patients achieved complete or partial response in this study.|||participants|||Number
2728514|NCT01029912|Primary|Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).|"The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.~Lower times are considered to be a better outcome.~For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged."|2 timepoints: Prior to treatment, and End of treatment at 6 weeks.||||seconds||Standard Error|Mean
2728515|NCT01029912|Primary|Change in Gait Velocity (cm/Sec) at End of Treatment|Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.|2 timepoints: Prior to treatment, and End of treatment at 6 weeks.||||cm/sec||Standard Error|Mean
2728516|NCT01029912|Primary|Change in Lower Extremity Fugl-Meyer Score at End of Treatment|"The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0.~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and End of treatment at 6 weeks.||||units on a scale||Standard Error|Mean
2728517|NCT01029886|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.|||events per subject-year||Standard Error|Mean
2728518|NCT01029886|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26|Change in DBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmHg||Standard Error|Least Squares Mean
2728779|NCT01027897|Primary|Elimination Constant (ke)|The elimination rate constant of a drug from the central compartment|after 3rd dose of study drug|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation|||per hour||Standard Deviation|Mean
2728519|NCT01029886|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|Change in SBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmHg||Standard Error|Least Squares Mean
2728520|NCT01029886|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||ratio||Standard Error|Least Squares Mean
2728521|NCT01029886|Secondary|Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|Change in HDL-C from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmol/L||Standard Error|Least Squares Mean
2728522|NCT01029886|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in total cholesterol from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmol/L||Standard Error|Least Squares Mean
2728523|NCT01029886|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||kg||Standard Error|Least Squares Mean
2728524|NCT01029886|Secondary|Change in Fasting Serum Glucose From Baseline to Week 26|Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmol/L||Standard Error|Least Squares Mean
2728525|NCT01029886|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 26|Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. Missing data at endpoint was imputed using last observation carried forward approach.|||percentage of patients|||Number
2728526|NCT01029886|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population: all patients who were randomized and received study drug. All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2728527|NCT01029795|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks.|No participants had data analyzed due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
2728528|NCT01029795|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
2728529|NCT01029795|Secondary|Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period|Assigned afternoon dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
2728530|NCT01029795|Secondary|Mean Morning Dose of LY2599506 During the 12-week Treatment Period|Assigned morning dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
2728531|NCT01029795|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to the insufficient sample size.|||beats per minute (bpm)||Standard Deviation|Mean
2728590|NCT01029652|Secondary|Time to First Intake of Rescue Medication After the Last Post Baseline Flare.|The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in analysis.|||Hours||95% Confidence Interval|Median
2728532|NCT01029795|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAJ was terminated after enrolling 38 participants. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes per 30 days|||Number
2728533|NCT01029795|Secondary|Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (Pop PK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.|||nanograms per milliliter times hour||Standard Deviation|Mean
2728534|NCT01029795|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (PopPK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.|||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
2728535|NCT01029795|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.|||percentage of participants|||Number
2728536|NCT01029795|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
2728537|NCT01029795|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2728538|NCT01029795|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||kilograms (kg)||Standard Deviation|Mean
2728539|NCT01029795|Secondary|Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant felt s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes|||Number
2728540|NCT01029795|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBP minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||mm Hg||Standard Deviation|Mean
2730111|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pulse oximetry|During surgical procedure|per protocol|||Percent oxyhemoglobin saturation||Standard Deviation|Mean
2728541|NCT01029795|Secondary|Change From Baseline in the Perceptions About Medications - Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks|"PAM-D assesses participants' perceptions about their diabetes medications during the past month. Responses ranged from None of the time, to All of the time. The sum of all items in the scale equals the scale score, which was linearly transformed to a 0 (least favorable state) to 100 (most favorable state). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed."|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2728542|NCT01029795|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2728543|NCT01029795|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2728544|NCT01029795|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2728545|NCT01029795|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2728546|NCT01029795|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2728547|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.|||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
2728548|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.|||percentage of beta cell function (%B)||Standard Deviation|Mean
2728549|NCT01029795|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.|||milliseconds (ms)||Standard Deviation|Mean
2730112|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pule oximeter|Immediately prior to surgery|per protocol|||Percent oxyhemoglobin saturation||Standard Deviation|Mean
2728550|NCT01029795|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2728551|NCT01029782|Primary|The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid.||72 hours|Per-Protocol Analysis at 72 hours.|||Participants|||Count of Participants
2728552|NCT01029730|Secondary|Number of Participants With Adverse Events as a Measure of Safety.|Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in >1 patient|Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.|All patients|||participants|||Number
2728553|NCT01029730|Secondary|Median Progression-free Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.||||months||95% Confidence Interval|Median
2728554|NCT01029730|Secondary|Overall Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At 3 and 6 months during treatment, then 6 months post-treatment.|All patients evaluable for response.|||percentage of evaluable participants|||Number
2728555|NCT01029730|Primary|Complete Response Rate|Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.|18 months|All evaluable patients|||percentage of evaluable participants|||Number
2728556|NCT01029704|Secondary|Changes From the Baseline in the Urinary Glucose Excretion at End of 28 Days|Urinary glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (day 1) from urinary glucose level at end of treatment (day 28) (i.e urinary glucose level on day 28 minus urinary glucose level on Day 1).|baseline (day 1) and 28 days||||g/24h||Standard Deviation|Mean
2728557|NCT01029704|Secondary|Changes From the Baseline in the Hemoglobin A1c (HbA1c) at End of 28 Days|HbA1c levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the HbA1c level during the study period was calculated by reducing the baseline HbA1c level (day 1) from HbA1c level at end of treatment (day 28) (i.e HbA1c level on day 28 minus HbA1c level on Day 1).|baseline (day 1) and 28 days||||Percent||Standard Deviation|Mean
2728558|NCT01029704|Secondary|Change From the Baseline in the Body Weight at End of 28 Days|Body weight was measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the body weight during the study period was calculated by reducing the baseline body weight (day 1) from body weight at end of treatment (day 28) (i.e body weight on day 28 minus body weight on Day 1).|baseline (day 1) and 28 days||||Kg||Standard Deviation|Mean
2728559|NCT01029704|Primary|Changes From the Baseline in the Fasting Plasma Glucose at End of 28 Days|Fasting glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the fasting plasma glucose level during the study period was calculated by reducing the baseline glucose level (day 1) from glucose level at end of treatment (day 28) (i.e glucose level on day 28 minus glucose level on Day 1).|baseline (day 1) and 28 days||||mg/dL||Standard Deviation|Mean
2728560|NCT01029691|Secondary|NICU Admission|Number of mothers who had one (or more) babies admitted to NICU|at delivery (within 6 months of enrollment)||||Participants|||Count of Participants
2728561|NCT01029691|Secondary|Birth Weight||At delivery (within 6 months of enrollment)|There is one extra baby in each arm to represent the twins born in each group.|||grams|babies|Standard Deviation|Mean
2728562|NCT01029691|Secondary|Gestational Age at Delivery||At delivery (within 6 months of enrollment).||||weeks||Standard Deviation|Mean
2728563|NCT01029691|Primary|Number of Participants With Sleep-disordered Breathing (SDB)|Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)|Baseline night 1|This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).|||Participants|||Count of Participants
2728564|NCT01029691|Primary|Severity of Sleep Disordered Breathing|Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.|at baseline|This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).|||apnea/hypopnea index||Standard Deviation|Mean
2728565|NCT01029691|Primary|Number of Participants With Worsening of Hypertension|This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.|1-6 months after enrollment.|One woman in the standard of care group died during pregnancy and is therefore not included in this analysis.|||participants|||Number
2728566|NCT01029691|Primary|Nocturnal Blood Pressure|measured by a 24 hour cuff, averaged across the night;|baseline and 1 week after PAP treatment.|The standard of care group did not have nocturnal blood pressure monitoring as they were not assigned to use a positive airway pressure device|||mmHg||Standard Deviation|Mean
2728567|NCT01029652|Secondary|Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
2728568|NCT01029652|Secondary|Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
2728569|NCT01029652|Secondary|Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab."|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
2728570|NCT01029652|Secondary|Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
2728571|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
2728572|NCT01029652|Secondary|Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
2728589|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was applied to impute post dose measurements.|||mm||Standard Error|Least Squares Mean
2728573|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.|||Participants|||Number
2728574|NCT01029652|Secondary|Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab|Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included|||mg/L||Standard Deviation|Mean
2728575|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab|High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included|||mg/L||Standard Deviation|Mean
2728576|NCT01029652|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||New flares per patient per year||Standard Deviation|Mean
2728577|NCT01029652|Secondary|Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||days||95% Confidence Interval|Median
2728578|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|7 days post dose (randomization), 24 weeks post-dose|Full Analysis Set includes all patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
2728579|NCT01029652|Secondary|Physician's Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)|Full Analysis Set (FAS): All patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
2728580|NCT01029652|Secondary|Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|"The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that there is pain, patient states there is pain and winces, and patient states there is pain, winces, and withdraws on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported."|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
2728780|NCT01027897|Primary|Clearance (CL)|Clearance is the volume of drug removed from the body per unit of time (hrs).|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation|||liters per hour||Standard Deviation|Mean
2728581|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.|||Participants|||Number
2728582|NCT01029652|Secondary|Patient's Global Assessment of Response to Treatment|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
2728583|NCT01029652|Secondary|Physician's Global Assessment of Response to Treatment|The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment).|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
2728584|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.|||mg/L||95% Confidence Interval|Least Squares Mean
2728585|NCT01029652|Secondary|Percentage of Participants Who Took Rescue Medication|Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.|during 12 weeks core, 24 weeks overall|"The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. 12 weeks:Core consisted of patients taking rescue medication during baseline flare of Core study and 24 weeks:Overall consisted of patients who took rescue medication during last post-baseline flare during 24 weeks."|||Percentage of participants|||Number
2728586|NCT01029652|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|7 days last post-baseline flare (during 24 weeks)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations at 7 days last post-baseline flare were included in this analysis.|||mg||Standard Deviation|Mean
2728587|NCT01029652|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||mm||Standard Error|Least Squares Mean
2728588|NCT01029652|Secondary|Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)|Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|Last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.|||Percentage of participants|||Number
2728601|NCT01029535|Secondary|Change From Baseline in the Subject's Self-Perception of Age (SPA)|The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||years||Standard Deviation|Mean
2728591|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||New flares/patient/24 weeks||Standard Deviation|Mean
2728592|NCT01029652|Secondary|Time to First New Flare|"Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Days||95% Confidence Interval|Median
2728593|NCT01029652|Secondary|SF36 Physical Function Score at Week 12|The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participant observations at Week 12 were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2728594|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||New flares/patient/12 weeks||Standard Deviation|Mean
2728595|NCT01029652|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Percentage of participants|||Number
2728596|NCT01029652|Secondary|Percentage of Participants With Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2728597|NCT01029652|Secondary|Time to Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Hours||95% Confidence Interval|Median
2728598|NCT01029652|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|From baseline to 7 days post dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||Hours||95% Confidence Interval|Median
2728599|NCT01029652|Primary|Time to First New Flare|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Days||95% Confidence Interval|Median
2728600|NCT01029535|Secondary|Percentage of Participants Satisfied or Very Satisfied With the Treatment|Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.|Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
2728847|NCT01027754|Secondary|Number of Counseling Visits Completed|Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.|End of 12 week intervention period||||visits completed||Standard Deviation|Mean
2728602|NCT01029535|Secondary|Subject's Assessment of Global Aesthetic Improvement Score (GAIS)|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2728603|NCT01029535|Secondary|Physician Assessment of Global Aesthetic Improvement Score (GAIS)|The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2728604|NCT01029535|Secondary|Change From Baseline in the MFVDS Score|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2728605|NCT01029535|Secondary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)|The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
2728606|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104|The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728607|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78|The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728608|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52|The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728609|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104|The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728610|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78|The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728611|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52|The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728612|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728613|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728614|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
2728615|NCT01029535|Primary|Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
2728616|NCT01029535|Primary|Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 4|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of particpants|||Number
2728617|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8|The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of particpants|||Number
2728618|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4|The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
2728619|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
2728620|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
2728621|NCT01029405|Secondary|Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.|Day 42|Intent-to-treat population included all randomized participants who received the study medication.|||percenatge of participants|||Number
2728622|NCT01029405|Primary|Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.|Day 42|Intent-to-treat population included all randomized participants who received study medication.|||percenatge of participants|||Number
2728623|NCT01029392|Secondary|Change in Insulin Requirements|Percentage change from baseline number of units of lantus insulin over 6 months.|6 months|20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.|||percentage change of baseline insulin||Standard Deviation|Mean
2728624|NCT01029392|Primary|Change in Hemoglobin A1c|Change in hemoglobin A1c calculated as a percentage change from baseline measurement|6 months|20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.|||percentage change from baseline||Standard Deviation|Mean
2728625|NCT01029366|Secondary|Overall Response Summary|"Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2013 v.1).~Efficacy assessments for CLL were based on lymphadenopathy, hepatomegaly, splenomegaly, bone marrow and blood morphologic and laboratory assessments. The response criteria are consistent with NCCN Guidelines Version 2.2012 CLL/SLL, which is based on the 2008 International Workshop Group on CLL (IWCLL) revisions of the original guidelines for evaluating disease response released in 1996 by the National Cancer Institute Working Group (NCI/WG)."|5 years||||percentage of participants|||Number
2728626|NCT01029366|Primary|Number of Participants With Adverse Events||5 years||||participants|||Number
2728627|NCT01029340|Secondary|Part C - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|at the time of surgery|ITT|||Participants|||Number
2728628|NCT01029340|Secondary|Part B - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|An average of 1 month after start of treatment|ITT|||Participants|||Number
2728629|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|before and 3 weeks after surgery|ITT|||Participants|||Number
2728630|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 12 months after drug administration|ITT|||Participants|||Number
2728638|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Utility Index as Measured by EQ-5D Questionaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 61 of the 62 participants had data available for the Utility Index of the EQ-5D questionnaire at Month 12.|||Scores on a scale||Full Range|Median
2728639|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Quality of Life (QoL) as Measured by Transformed Total Score of Haemo-QoL Questionnaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 51 of the 62 participants had data available for the 12-month QoL analysis.|||Scores on a scale||Full Range|Median
2728640|NCT01029340|Secondary|Part B - Control of Bleeding as Measured by the Number of Injections Required to Treat a Bleed|The number of injections needed by participants to stop a bleed|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.|||Injections|Participants|Full Range|Median
2728641|NCT01029340|Secondary|Part B - Annualized Number of Bleeds in Each 6-month Potency Assignment Period|The annualized number of bleeds experienced by participants in each of the two treatment periods|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.|||Bleeds||Inter-Quartile Range|Median
2728642|NCT01029340|Secondary|Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII)|The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period.|15-30 minutes after the injection|ITT. 1 measurement was taken in all participants at the start of the CS/EP labelled treatment period (CS/ADJ labelled treatment was experimental and will not be used for the future commercial drug, so no measurements were taken). Note: Only 59 of the 62 participants had valid recovery data.|||Kg/dL||Inter-Quartile Range|Median
2728643|NCT01029340|Primary|Part B - Annualized Number of Total Bleeds|The annualized number of bleeds experienced by participants|12 months after randomization|Intent to treat (ITT)|||Bleeds||Inter-Quartile Range|Median
2728644|NCT01029340|Primary|Part A - Half-life (t 1/2)|To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.|PK Analysis Population|||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
2728645|NCT01029340|Primary|Part A - Area Under the Drug Concentration-time Curve (AUC)|To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.|PK Analysis Population|||Int.units x hours/deciliters (IU*h/dL)||Geometric Coefficient of Variation|Geometric Mean
2728646|NCT01029262|Secondary|Healthcare Resource Utilization (HRU): Number of Days of Hospitalization Due to Adverse Events Per Person-Years|Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|Safety population includes all participants who received at least 1 dose of study drug.|||Days per person-years||95% Confidence Interval|Number
2728647|NCT01029262|Secondary|Healthcare Resource Utilization (HRU): Duration of Hospitalizations Due to Adverse Events|Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|Participants with at least one hospitalization.|||Days||Full Range|Median
2728648|NCT01029262|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Related to Adverse Events Per Person Year|Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|Safety population includes all participants who received at least 1 dose of study drug.|||Hospitalizations per person-years||95% Confidence Interval|Number
2728649|NCT01029262|Post-Hoc|Percentage of Participants Who Achieved an Erythroid Response Based on Original IWG 2006 Criteria|"A participant was considered as having achieved an erythroid response when:~- a Hgb increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that had also increased ≥1.5 g/dL for at least 8 weeks. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe can be less than a 1.5 g/dL) OR - had an absolute reduction of 4 RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.~The baseline transfusion burden is the number of units over the 112 days prior to randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9.5 g/dL or less may be used in this response assessment."|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|Intent to treat population includes all participants who were randomized.|||percentage of participants|||Number
2728848|NCT01027754|Secondary|Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.||Week 24||||participants|||Number
2728849|NCT01027754|Primary|Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.||Week 12||||participants|||Number
2728650|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||percentage of participants|||Number
2728651|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point are included.|||percentage of participants|||Number
2728652|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point are included.|||percentage of participants|||Number
2728653|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||percentage of participants|||Number
2728654|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||percentage of participants|||Number
2728681|NCT01028911|Secondary|Maximum Plasma Concentration (Cmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||ng/mL||Standard Deviation|Geometric Mean
2728655|NCT01029262|Secondary|Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728656|NCT01029262|Secondary|Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728657|NCT01029262|Secondary|Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728658|NCT01029262|Secondary|Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728659|NCT01029262|Secondary|Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline, Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2728682|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||ng*hr/mL||Standard Deviation|Geometric Mean
2730113|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Rate of respirations|During surgical procedure|per protocol|||Breaths per Minute||Standard Deviation|Mean
2728660|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline and Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||Standard Deviation|Mean
2728661|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline and Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||Standard Deviation|Mean
2728662|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline and Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||Standard Deviation|Mean
2728663|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline and Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||Standard Deviation|Mean
2728664|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline and Week 12, ±3 days and Week 24, ±3 days|Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included.|||units on a scale||Standard Deviation|Mean
2728683|NCT01028911|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||hours||Full Range|Median
2728684|NCT01028911|Secondary|Maximum Serum Concentration (Cmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||nanogran per millileter (ng/mL)||Standard Deviation|Geometric Mean
2728685|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2741759|NCT00939809|Secondary|Overall Survival||Every other cycle, up to 5 years|Eligible and treated participants|||months||95% Confidence Interval|Median
2728665|NCT01029262|Secondary|Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked.|Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Data is available up to Week 48 due to small sample after that.|||percentage of participants|||Number
2728666|NCT01029262|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|"A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|From the first dose of study drug through 28 days after discontinuation from the study treatment; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide arm and 529 days in the placebo arm.|Safety population includes all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2728667|NCT01029262|Secondary|Kaplan Meier Estimate for Overall Survival (OS)|Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive.|From randomization to final data cut-off date of 03 July 2018; maximum survival follow up was 6.4 years|The ITT population includes all participants who were randomized to either lenalidomide or placebo.|||years||95% Confidence Interval|Median
2728668|NCT01029262|Secondary|Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)|Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact.|From randomization to final data cut-off date of 03 Jul 2018; median follow up time for progression to AML was 2.3 years (range = 0 to 5.0 years) in the placebo arm and 2.6 years (range = 0 to 6.4 years) in the lenalidomide arm.|ITT population includes all participants who were randomized and received either lenalidomide or placebo. One participant in the placebo arm was diagnosed as having AML before enrollment and was excluded from all analyses of progression to AML.|||years||95% Confidence Interval|Median
2728669|NCT01029262|Secondary|Time to 56-Day RBC-Transfusion-Independent (TI) Response as Determined by the Sponsor|The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period - the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|From first dose of study drug until 28 days after the last dose of study drug, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.|||weeks||Full Range|Median
2728670|NCT01029262|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on the Modified International Working Group (IWG) 2006 Criteria|"A participant was considered as having achieved an erythroid response if the participant either:~- had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL) OR - had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.~The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less were used in this response assessment."|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|The ITT population includes all participants who were randomized to either lenalidomide or placebo.|||percentage of participants|||Number
2728723|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||mmHg||Full Range|Median
2728671|NCT01029262|Secondary|Kaplan Meier Estimates of Duration of 56-day RBC Transfusion Independence Response as Determined by the Sponsor|"The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):~For those who received a subsequent RBC transfusion after the response starts, the duration of response was not censored, and was calculated as response duration = last day of response - first day of response +1 where the last day of response was defined as 1 day before the first RBC transfusion which was given at 56 days or more after the response starts.~For those who did not receive a subsequent RBC transfusion after the response started, the end day of the response was censored and duration of the response was calculated as response duration = date of last RBC transfusion assessment - first day of response+ 1. A responder was a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first study drug treatment period"|Response was assessed up to the end of treatment; up to the data cut-off date of 17 Mar 2014.|The analysis was conducted only for those participants who achieved a 56-day transfusion independence response according to the sponsor's assessment. Responders in the intent to treat population.|||weeks||95% Confidence Interval|Median
2728672|NCT01029262|Secondary|Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor|"The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive rolling 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase."|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|The ITT population includes all participants who were randomized to either lenalidomide or placebo.|||percentage of participants|||Number
2728673|NCT01029262|Primary|Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|"The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive rolling 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder."|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|Analysis population includes ITT participants with an erythroid gene expression signature.|||percentage of participants|||Number
2728674|NCT01029262|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|"The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive rolling 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose"|From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.|The Intent-to-Treat (ITT) population includes all participants who were randomized to either lenalidomide or placebo.|||percentage of participants|||Number
2728675|NCT01029054|Primary|The Percentage of Patients That Achieve a Response to Treatment|"The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.~sCR is defined as:~Negative immunofixation on the serum and urine and~Disappearance of any soft tissue plasmacytomas and~< 5% plasma cells in bone marrow and~Normal SFLC ratio and~Absence of clonal cells in bone marrow~VGPR is defined as:~Serum and urine M-protein detectable by immunofixation but not on electrophoresis or~≥ 90% reduction in serum M-component with urine M-component < 100 mg per 24 hours~PR is defined as:~≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours~If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required"|4 Months After Treatment Start||||percentage of patients|||Number
2728676|NCT01029054|Secondary|The Percentage of Patients Alive Without Progression|"The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.~Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia."|12 Months and 24 Months Post Treatment||||percentage of patients|||Number
2728677|NCT01029054|Primary|The Maximum Tolerated Dose (MTD) of Carfilzomib|Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.|6 Months|Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.|||mg/m^2|||Number
2728678|NCT01028937|Secondary|The Proportion of Eyes That Achieve Distance Uncorrected Visual Acuity (D-UCVA) of 20/40 or Better Following Tx and the Proportion of Eyes That Achieve D-UCVA of 20/40 or Better as a Function of the Pre-Tx D-UCVA Will Both be Reported.|The proportion of eyes that achieve distance uncorrected visual acuity (D-UCVA) of 20/40 or better following Tx and the proportion of eyes that achieve D-UCVA of 20/40 or better as a function of the pre-Tx D-UCVA will both be reported.|1 year post-treatment|1 year follow-up|||Eyes|Eyes||Count of Units
2728679|NCT01028937|Primary|The Proportion of Eyes (Target: at Least 85%) That Achieve Successful Distance Uncorrected Visual Acuity (D-UCVA) Improvement Defined as 2 Lines (10 Letters) or More Improvement in D-UCVA Following Tx Will be Reported.|The proportion of eyes (target: at least 85%) that achieve successful distance uncorrected visual acuity (D-UCVA) improvement defined as 2 lines (10 letters) or more improvement in D-UCVA following Tx will be reported|1 year post-treatment|Eyes|||Eyes|Eyes||Count of Units
2730114|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Respirations per minute|Immediately prior to sedation|Randomized per protocol|||Breaths per Minute||Standard Deviation|Mean
2728686|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Follow-up|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728687|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 30|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728688|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 25|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728689|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 20|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728690|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 15|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728691|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 10|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728692|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 5|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728693|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Follow-up|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728694|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 30|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728695|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 25|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728696|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 20|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2731538|NCT01007123|Primary|Change From Baseline in Frequency of Spontaneous Bowel Movements|Primary ep W 1|Baseline, weekly, up to 8 weeks|ITT population|||Number of SBMs||Standard Error|Least Squares Mean
2728697|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 15|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728698|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 10|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728699|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 5|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728700|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Follow-up|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728701|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 30|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 30|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728702|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 25|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728703|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 20|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728704|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 15|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2750579|NCT00871715|Secondary|Upper Extremity Fugl Meyer (UEFM), Motor Component||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2728705|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 10|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728706|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 5|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728707|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2728708|NCT01028911|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
2728709|NCT01028911|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/>1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs), urine epithelial cells (>=6 high-powered field), urine bacteria >20 high-powered field; qualitative urine glucose, ketones, protein values >=1 in urine dipstick test. Total number of participants with any laboratory abnormalities was reported.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
2728710|NCT01028911|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=200 msec, maximum fridericia's corrected QT (QTcF) interval >=500 msec, PR interval or QRS interval increase from baseline >=25 percent (%) or 50 percent (%), QTCF interval increase from baseline 30 to 60 msec or >=60 msec.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
2728711|NCT01028911|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (SBP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm, standing pulse rate <40 bpm or >140 bpm. Maximum increase or decrease from baseline in supine (Su) and standing (St) SBP >=30 mmHg and maximum increase or decrease from baseline in supine and standing DBP >=20 mmHg.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
2728712|NCT01028820|Primary|Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version|The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS—PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant.|"Baseline (Pre-Dose) to 8 Weeks (Post-Dose)"|All randomized participants' scores were analyzed using the PDD-CYBOCS measure. Higher values reflect worse outcomes. Subscales are added to compute the total score (total score does not include compulsion free-interval and peculiarity of the behavior.|||Scores on a scale||Standard Deviation|Mean
2731539|NCT01007110|Secondary|Cardiac Conduction Time||Change from Baseline to 2 Months Post-natal||||milliseconds||Standard Deviation|Mean
2728713|NCT01028820|Secondary|Total Repetitive Behavior Scale - Revised (RBS_R)|"The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.~The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129."|baseline week 0, 8 weeks|All randomized participants' scores were analyzed using the RBS-R measure. Higher values reflect worse outcomes (greater symptom severity). Subscales are added to compute the total score.|||units on a scale||Standard Deviation|Mean
2728714|NCT01028677|Primary|Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks|"The Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response.~Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35"|6 weeks||||rating on a scale||Standard Deviation|Mean
2728715|NCT01028677|Primary|Social Perception as Measured by the Trustworthiness Task at 6 Weeks|The Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.'s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.|6 weeks||||rating on a scale||Standard Deviation|Mean
2728716|NCT01028677|Primary|Theory of Mind as Measured by the Brune Test at 6 Weeks|In The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant's interpretations of the characters' beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.|6 weeks||||correct responses||Standard Deviation|Mean
2728717|NCT01028677|Primary|Theory of Mind as Measured by the Eyes Test at 6 Weeks|The Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, & Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).|6 weeks||||correct responses||Standard Deviation|Mean
2728718|NCT01028677|Secondary|Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks|"The PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome).~Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112"|6 weeks||||rating on a scale||Standard Deviation|Mean
2728719|NCT01028677|Primary|Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point|"The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, & Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified).~The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity."|6 weeks||||number of correct responses||Standard Deviation|Mean
2728720|NCT01028651|Secondary|Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24|NT-proBNP was assessed at Baseline, Weeks 12 and 24.|Baseline to Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||pg/mL||Full Range|Median
2728721|NCT01028651|Secondary|Change in Quality of Life From Baseline to Weeks 12 and 24|The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||units on a scale||Full Range|Median
2728722|NCT01028651|Secondary|Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||cm||Full Range|Median
2731534|NCT01007123|Secondary|LDL/HDL Ratio|Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted|Baseline and 8 weeks of treatment|ITT population|||Ratio||Standard Error|Least Squares Mean
2728724|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||mm||Full Range|Median
2728725|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||cm2||Full Range|Median
2728726|NCT01028651|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.|The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24|||Meters||Full Range|Median
2728727|NCT01028651|Secondary|Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24|The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24|||Wood Units||Full Range|Median
2728728|NCT01028651|Secondary|Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24|The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24|||percentage bound to hemoglobin||Full Range|Median
2728729|NCT01028651|Secondary|Change in Cardiac Output at Rest From Baseline to Week 24|The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented.|24 weeks|All subjects with data available at Baseline and Week 24|||L/min||Full Range|Median
2728730|NCT01028651|Secondary|Change in Heart Rate at Rest From Baseline to Week 24|The change in heart rate was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24|||beats/min||Full Range|Median
2728731|NCT01028651|Secondary|Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24|The change in hemodynamic parameters (including systolic pulmonary arterial pressure [PAPs], diastolic pulmonary arterial pressure [PAPd], mean pulmonary arterial pressure [mPAP], and transpulmonary gradient [TPG]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented.|24 weeks|All subjects with data available at Baseline and Week 24|||mmHg||Full Range|Median
2728732|NCT01028651|Primary|Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.|The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH).|24 Weeks|The total number of subjects enrolled and analyzed.|||participants|||Number
2728733|NCT01028560|Secondary|Incidence Rate of Systemic Corticosteroid Bursts (CSB) Per Child|"Any reported use of consequent systemic corticosteroid use due to asthma exacerbation counted as one corticosteroid burst (CSB). For example, if a child used 5 days of prednisolone due to asthma exacerbation, this counted as one corticosteroid burst (CSB). An interval of at least 7 days was determined to be necessary to count 2 courses of systemic corticosteroids as separated bursts.~The presented data reflect the intention-to-treat analysis. The time between baseline and each participant's study end time was counted towards the years in study. The incidence rate describes the number of CSB per child per year in study."|From baseline through end of study (maximum 36 months)|Participants with available data (intention to treat population)|||Number of CSB per child per year||95% Confidence Interval|Mean
2728734|NCT01028560|Secondary|Peripheral Blood T Regulatory Cells as a Percentage of CD4+ (Cluster of Differentiation 4) Cells|T regulatory cells are thought to play a role in mediating the effects of immunotherapy in increasing allergen tolerance and dampen the clinical expression of allergy. However, existing studies have not found clear relationship between numbers of T regulatory cells in blood and effect of immunotherapy. The aim of this analysis was to observe potential changes in T regulatory cell numbers in response to immunotherapy in this age group. Peripheral blood cells were acquired and analyzed for T regulatory (Treg) cell markers. In molecular biology, CD4+ (cluster of differentiation 4), a particular cell marker, is a glycoprotein found on the surface of immune cells such as T helper cells and certain groups of T regulatory cells. Testing was done at baseline and then every 12 months. Reported values represents the percentage of CD4+ that are Treg cells.|Baseline and every 12 months until end of treatment (36 months)|Only 27 participants had yearly data for Treg cells from baseline through 36 months (+/- 6 months). Data for 23 participants were not included in the analysis because either parents declined to have blood drawn or because results were not returned from the outside laboratory (despite many efforts to retrieve these data).|||% of CD4+ cells are Treg cells||Standard Error|Least Squares Mean
2728735|NCT01028560|Secondary|Number of Newly Gained Allergic Sensitizations as Assessed by Serum Specific Immunoglobulin E (IgE) Testing|"Young children with allergies tend to develop additional environmental allergies over time. This study investigated if allergy immunotherapy could be used to prevent the development of new allergic sensitizations. Participants were tested for sensitivity to a panel of 8 common environmental allergens. Testing was conducted via serum specific immunoglobulin E (IgE) testing. A test was considered negative (non-allergic) if the specific IgE level was <0.35 kIU/L (Kilo International Units/Liter) and positive (allergic) if the levels was >0.35 kIU/L. A test pair is the result of a serum IgE test, for a specific allergen, done at two different times. Test pairs can be negative-negative, negative-positive (newly gained allergic sensitization), positive-negative (lost sensitization) or positive-positive. Reported values indicate the total number of newly gained allergic sensitization (negative-positive) for the group."|Baseline and end of treatment (36 months)|In the intention to treat analysis, only 30 children (15 in each group) had serum tests available at baseline and after 36 months of the study.|||Newly gained allergic sensitizations|test pairs (baseline and at 36+/-6months||Number
2743973|NCT00924781|Primary|Number of Participants With Composite Events of Transfusion-Related Adverse Experiences||12 weeks||||Participants|||Number
2728736|NCT01028560|Primary|Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months)|The Asthma Severity Score is a customized score created for this study due to the lack of standardized instruments for this age group. It takes into account asthma symptom severity and frequency, as well as asthma medication dosing and potency. Data was collected at baseline and every 2 weeks through interviews conducted over the phone. If the caregiver could not be reached by the phone, the interview was conducted at the next face-to face opportunity (study or injection visit). The minimum score on this scale is 0 (no asthma symptoms and no asthma medicines used during the 14 day interview period). The maximum score is 224 (uncontrolled severe asthma with severe cough, shortness of breath and wheezing on 14 of 14 days, using Albuterol 2 puffs 4x/day, budesonide/formoterol 160ug/4.5ug 2 puffs twice daily and Montelukast 4mg daily on 14 of 14 days). Scores calculated from the collected data were averaged to produce one reported value at baseline and year 1, 2 and 3.|baseline and every two weeks up to end of study (up to 36 months)|All participants were included in this analysis that started immunotherapy, regardless if they completed it or not (intention to treat analysis)|||score on a scale||Standard Error|Least Squares Mean
2728737|NCT01028391|Secondary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the extension study. For FAS patients with no data at Week 54, the last observed measurement during extension study was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
2728738|NCT01028391|Primary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54|HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 54 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the 30-week extension study. For FAS patients with no data at Week 54, the last observed measurement during the 30-week extension study was carried forward to Week 54.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
2728739|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728740|NCT01028378|Primary|Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728741|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728742|NCT01028378|Primary|Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728743|NCT01028378|Primary|Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728744|NCT01028378|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728745|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728746|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728747|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
2728748|NCT01028352|Secondary|Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)|A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between.|Baseline, 2, 4 , 6 and 8 weeks||||%of participants with 30% pain reduction||95% Confidence Interval|Number
2728749|NCT01028352|Primary|Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.|Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.|8 weeks|Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine|||percentage of participants|||Number
2728750|NCT01028300|Secondary|No Implant Related Complications||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
2728751|NCT01028300|Secondary|No Re-operations, Revisions, Removals or Supplemental Fixation||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
2728752|NCT01028300|Secondary|Time to Return to Active Duty||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
2728753|NCT01028300|Primary|The Primary Endpoint of This Study is the Assessment of the Mean Oswestry Low Back Pain Disability Questionnaire (ODI) Improvement at the Twelve (12) Month and Twenty-four (24) Month Follow-up Visits Relative to Baseline.||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
2728755|NCT01028222|Secondary|PFS Rate|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Percentage of participants|||Number
2728756|NCT01028222|Secondary|Disease Control Rate (DCR)|DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Participants|||Number
2728757|NCT01028222|Secondary|Time to Objective Response (TOR)|TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||months||95% Confidence Interval|Median
2728758|NCT01028222|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Months||95% Confidence Interval|Median
2728759|NCT01028222|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Months||95% Confidence Interval|Median
2728760|NCT01028222|Secondary|Durable Overall Response Rate (DORR)|DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Participants|||Number
2728761|NCT01028222|Primary|Overall Response Rate (ORR)|ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Participants|||Number
2728762|NCT01028131|Primary|Urinary Cotinine|Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.|8 week follow-up||||participants|||Number
2728763|NCT01028131|Primary|Smoking Behavior (Self-report Confirmed by Expired Breath CO)|All participants were analyzed as assigned. Total N was determined primarily by resource availability in this Stage Ib trial. Number represents number of abstinent participants in each condition.|8 week follow up||||participants|||Number
2728764|NCT01028053|Secondary|The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.|Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.|Up to 36 months post flutemetamol administration.|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).|||Number of subjects|||Number
2728765|NCT01028053|Primary|Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.|"Visual Interpretation of the PET scan by independent readers.~Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases.~Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included)."|Up to 36 months post flutemetamol administration|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).|||Ratio of visual interpretations|||Number
2728766|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.|Baseline, Day 3|The ITT population was used for this secondary efficacy parameters.|||Score on a scale||Standard Deviation|Mean
2728767|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.|Baseline, Day 3|The PP population was used for this secondary efficacy parameters.|||Score on a scale||Standard Deviation|Mean
2728768|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population|The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 8|The ITT population was used in this secondary efficacy parameter.|||Score on a scale||Standard Deviation|Mean
2728769|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population|The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.|Baseline, Day 8|The PP population was used for this secondary efficacy parameters.|||Score on a scale||Standard Deviation|Mean
2728770|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population|The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 15|The ITT population was used in this secondary efficacy parameter.|||Score on a scale||Standard Deviation|Mean
2728771|NCT01028027|Primary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population|The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).|Baseline, Day 15|The PP population was the population used for the primary efficacy analysis.|||Scores on a scale||Standard Deviation|Mean
2728772|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry|Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.|||milliliters per second||Inter-Quartile Range|Median
2728773|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.|Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.|||Milliamps||Inter-Quartile Range|Median
2728774|NCT01028014|Primary|Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG|Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.|||microvolts||Inter-Quartile Range|Median
2728775|NCT01027910|Secondary|Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration.||2 years||||participants|||Number
2728776|NCT01027910|Secondary|Number of Partial Responses (PR)|number of patients who demonstrated partial response to therapy as determined by RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year||||participants|||Number
2728777|NCT01027910|Secondary|Dose Limiting Toxicities|number of patients who experienced dose limiting toxicities|1 year||||participants|||Number
2728778|NCT01027910|Primary|Maximum Tolerated Dose||up to 30 days after starting study drugs|The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2.|||mg/m2|||Number
2730727|NCT01012414|Secondary|Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A||1 year|Data were not collected when study was stopped prematurely.||||||
2728781|NCT01027897|Primary|Volume of Distribution (Vd)|The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation|||liters||Standard Deviation|Mean
2728782|NCT01027884|Secondary|Percentage of Patients Reporting Adverse Events||52 Weeks||||percentage of patients reporting AEs|||Number
2728783|NCT01027884|Secondary|Change From Baseline to Week 52 in Quality of Life Assessed by PedsQL™ Paediatric Quality of Life Inventory|"PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning.~Item Scaling:~5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7).~Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales.~The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome"|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with Baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2728784|NCT01027884|Secondary|Change From Baseline to Week 52 in Muscle Strength|"The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded.~The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N)."|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with baseline assessments|||Newtons||95% Confidence Interval|Mean
2728785|NCT01027884|Secondary|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.|||percentage of Predicted FVC||95% Confidence Interval|Mean
2728786|NCT01027884|Primary|Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.|||percentage||95% Confidence Interval|Geometric Mean
2728787|NCT01027871|Secondary|Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Baseline and Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
2728788|NCT01027871|Secondary|Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.|Baseline through Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance.|||Number of Hypoglycemia episodes/30 days||Standard Deviation|Mean
2728789|NCT01027871|Secondary|Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Baseline through Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance.|||percentage of participants|||Number
2728790|NCT01027871|Secondary|Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 2 and Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/kg||Standard Error|Least Squares Mean
2728791|NCT01027871|Secondary|8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
2728792|NCT01027871|Secondary|Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF).|||percentage of participants|||Number
2728793|NCT01027871|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF).|||percentage of participants|||Number
2728794|NCT01027871|Secondary|Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
2728795|NCT01027871|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
2728796|NCT01027871|Secondary|Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint|The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches.|Week 12|Participants who took at least one dose of study drug and had measurements at Week 12.|||picomoles per liter (pMol/L)||Geometric Coefficient of Variation|Geometric Mean
2728797|NCT01027871|Secondary|Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12|Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Baseline and Week12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
2728798|NCT01027871|Secondary|Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16|Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative.|Week 12 and Week 16|All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements.|||percentage of participants|||Number
2728799|NCT01027871|Secondary|Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.|Baseline through Week 12|All randomized participants who took at least one dose of study drug.|||Number of Hypoglycemia episodes/30 days||Standard Deviation|Mean
2728800|NCT01027871|Secondary|Percentage of Participants With Hypoglycemia From Baseline Through Week 12|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Baseline through Week 12|All randomized participants who took at least one dose of study drug.|||percentage of participants|||Number
2728801|NCT01027871|Secondary|Daily Basal Insulin Dose at Week 2 and Week 12|LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 2 and Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||nanomole per kilogram (nmol/kg)||Standard Error|Least Squares Mean
2728850|NCT01027702|Secondary|Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)|Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.|1 year|Patients who relapsed and received subsequent chemotherapy were no longer followed for infections as these therapies increase the risk of infections.|||participants|||Number
2728802|NCT01027871|Secondary|8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint|8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
2728803|NCT01027871|Secondary|Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Week 12|All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to|||percentage of participants|||Number
2728804|NCT01027871|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to|||percentage of participants|||Number
2728805|NCT01027871|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 dose algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
2728806|NCT01027871|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint|FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/Liter||Standard Error|Least Squares Mean
2728807|NCT01027871|Primary|Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles|8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c [HbA1c] group); visit; visit and treatment interaction; random effect for participant.|Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
2728808|NCT01027845|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From study start at Month 0 up to study end at Month 15-17|The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.|||Participants|||Count of Participants
2728809|NCT01027845|Secondary|Number of Subjects With Unsolicited AEs After Booster Vaccination|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post booster vaccination period|The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.|||Subjects|||Number
2728810|NCT01027845|Secondary|Number of Subjects With Unsolicited AEs After Primary Vaccination|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post-primary vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses.|||Subjects|||Number
2728851|NCT01027702|Primary|Incidence and Severity of GVHD|Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.|180 days after transplant|Patients that had not had grade II-IV acute GVHD following prophylactic DLI but received therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion prior to Day +180 were considered not evaluable because these therapies may cause or prevent GVHD and affect the determination of this endpoint.|||Participants|||Count of Participants
2728811|NCT01027845|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination|Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.|During the 8-day (Days 0-7) period following booster vaccination|The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose and who had their symptoms sheet filled in. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.|||Subjects|||Number
2728812|NCT01027845|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination|General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.|During the 8-day (Days 0-7) after each primary vaccine dose|The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses and who had their symptoms sheet filled in.|||Participants|||Count of Participants
2728813|NCT01027845|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 8-day (Days 0-7) period following booster vaccination|The analysis was performed on the Total Vaccinated cohort for booster epoch, which included all subjects having received the booster dose and who had their symptoms sheet filled in. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.|||Subjects|||Number
2728814|NCT01027845|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 8-day (Days 0-7) after each primary vaccine dose|The analysis was performed on the Total Vaccinated cohort for primary epoch, which included all subjects having received at least one of the 3 primary vaccination doses and who had their symptoms sheet filled in.|||Participants|||Count of Participants
2728815|NCT01027845|Secondary|Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)|Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL|Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization|Analysis was performed on the ATPcohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against PT or FHA before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e. subjects with or without Prevenar vaccination|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728816|NCT01027845|Secondary|Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)|Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Pertussis or Filamentous haemagglutinin after primary vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728817|NCT01027845|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)|Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.|Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization|Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against DT or TT before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2728818|NCT01027845|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)|Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Diphtheria Toxoid or Tetanus Toxoid after primary vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2728819|NCT01027845|Secondary|Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization|Analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects with assay results available for antibodies against Protein D before and after booster vaccination. Analysis was performed on the 10Pn Group and only on the pooled DTPa booster Group, i.e subjects with or without Prevenar vaccination|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728820|NCT01027845|Secondary|Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against Protein D after primary vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2728821|NCT01027845|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.|Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization|The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2728822|NCT01027845|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2728823|NCT01027845|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.|Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization|The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2728824|NCT01027845|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2728825|NCT01027845|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.|Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization|The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2728826|NCT01027845|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2728852|NCT01027702|Primary|Number of Participants With Immune Recovery Following Transplantation|Immune recovery was measured by CD4+ cells > 100/μL by Day 120 following transplantation|120 days after transplant|Patients who received subsequent therapy, such as therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion were considered not evaluable as this could interfere with response assessments.|||Participants|||Count of Participants
2729017|NCT01026805|Secondary|Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score|"a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator(1 = poor and 10 = excellent)."|2-3 months post treatment|All treating physicians completed a survey questionnaire.|||scores on a scale||Full Range|Mean
2728827|NCT01027845|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.~Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group."|Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization|The analysis was performed on the ATP cohort for immunogenicity for booster epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component before and after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2728828|NCT01027845|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)|Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).|1 month following primary immunization (at Month 3)|The analysis was performed on the ATP cohort for immunogenicity for primary epoch, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after primary vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2728829|NCT01027819|Secondary|Knee Society Score||6 months|||||||
2728830|NCT01027819|Primary|Rotational Angle Between Femur and Tibia||2 weeks|The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).|||degree||Standard Deviation|Mean
2728831|NCT01027806|Primary|The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.||16 weeks||||Participants|||Count of Participants
2728832|NCT01027780|Primary|Electroencephalography Measurement|Measurement of alpha asymmetry at the F3/4 (frontal) electrode. Left prefrontal activation has been associated with positive affect, and with higher levels of antibody responses and natural killer cell cytotoxicity.|post-treatment (time 2)|Some subject EEG recordings were excluded from analyses due to reading/equipment factors (e.g., poor signal, external noise) or subject factors (e.g., sleepiness, illness). Subjects were also allowed to opt out of the EEG procedures if desired.|||Log right-log left alpha power||Standard Error|Mean
2728833|NCT01027780|Primary|Trail Making Test|The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively), may be utilized individually, and as a difference (B-A) or ratio (B/A) score. The Trails B/A ratio was used as an index of improvement in executive control throughout the trial, with lower scores indicating better performance.|immediate post-treatment (Time 2)||||Trails B:A score||Standard Error|Mean
2728834|NCT01027780|Primary|IgG Anti-KLH Antibody Response Post-treatment|Immune function--specifically, antibody response to a novel, benign antigen (an antigen to which subjects are immunologically naïve); in this case, keyhole limpet hemocyanin (KLH).|Immediate post-treatment (time 2)||||OD 405 nm||Standard Error|Mean
2728835|NCT01027754|Secondary|Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview||over the intervention period (measured at weeks 2, 4, 8, 12, and 24)||||participants|||Number
2728836|NCT01027754|Secondary|Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview||over the intervention period (measured at weeks 2, 4, 8, 12, and 24)||||participants|||Number
2728837|NCT01027754|Secondary|Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview||over the intervention period (measured at weeks 2, 4, 8, 12, and 24)||||participants|||Number
2728838|NCT01027754|Secondary|Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale||over the intervention period (measured at weeks 2, 4, 8, 12, and 24)||||participants|||Number
2728839|NCT01027754|Secondary|Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory||over the intervention period (measured at weeks 2, 4, 8, 12, and 24)||||participants|||Number
2728840|NCT01027754|Secondary|Adverse Medication Effects||over the intervention period (measured at weeks 2, 4, 8, 12, and 24)||||participants|||Number
2728841|NCT01027754|Secondary|Importance of Quitting Smoking (1-10 Scale)|Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).|Weeks 2, 4, 8, 12, and 24||||units on a scale||Inter-Quartile Range|Median
2728842|NCT01027754|Secondary|Confidence in Quitting Smoking (1-10 Scale)|Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).|Weeks 2, 4, 8, 12, and 24||||units on a scale||Inter-Quartile Range|Median
2728843|NCT01027754|Secondary|Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours||Weeks 2, 4, 8, 12, and 24||||participants|||Number
2728844|NCT01027754|Secondary|Number of Cigarettes Smoked Per Day||Weeks 2, 4, 8, 12, and 24||||cigarettes/day||Inter-Quartile Range|Median
2728845|NCT01027754|Secondary|7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.|salivary cotinine ≤ 15 ng/ml using a semi-quantitative assay (Nymox NicAlert™)|Weeks 2, 4, 8, 12, and 24|Because of the high rate of missing data (6 of 51 cases of self-reported abstinence not verified by cotinine), and because the semi-quantitative assay we used (Nymox NicAlert™) did not use a ≤ 15 ng/ml threshold (10 of 51 cases fell in the 10–30 ng/ml range), this data was not analyzed.||||||
2728846|NCT01027754|Secondary|Number of Study Visits Completed|Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.|24 weeks||||visits completed||Standard Deviation|Mean
2728853|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Number of Letters Read Correctly||Standard Deviation|Mean
2728854|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Safety Population: all patients who received study treatment|||Number of Letters Read Correctly||Standard Deviation|Mean
2728855|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Microns||Standard Deviation|Mean
2728856|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Safety Population: all patients who received study treatment|||Microns||Standard Deviation|Mean
2728857|NCT01027650|Primary|Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Number of Letters Read Correctly||Standard Deviation|Mean
2728858|NCT01027650|Primary|Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Safety Population: all patients who received study treatment|||Number of Letters Read Correctly||Standard Deviation|Mean
2728859|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Microns||Standard Deviation|Mean
2728860|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Safety Population: all patients who received study treatment|||Microns||Standard Deviation|Mean
2728861|NCT01027598|Secondary|Objective Response Rate (ORR)|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|18 Months|Includes all patients who were evaluated for response|||percentage of evaluated participants|||Number
2728862|NCT01027598|Secondary|Overall Survival|The length of time, in months, that patients were alive from first date of protocol treatment until death.|18 months|All treated patients|||months||95% Confidence Interval|Median
2728863|NCT01027598|Primary|Progression-free Survival|The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|14 months|All treated patients|||months||95% Confidence Interval|Median
2728864|NCT01027559|Primary|Hamilton Depression Rating Scale Score at Baseline and 12 Weeks|The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment.|Baseline and 12 weeks|Numbers may differ from Participant Flow but these are the totals of those participants who had data at this time point for the Hamilton Depression Rating Scale.|||units on a scale||Standard Deviation|Mean
2728911|NCT01027351|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, Booster response.|||AU/mL||95% Confidence Interval|Geometric Mean
2729018|NCT01026805|Secondary|Resected Tissue Weight Per Patient|mean weight of resected tissue per patient|at time of treatment||||g||Full Range|Mean
2728865|NCT01027559|Primary|Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.|MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.|baseline visit and 8-week follow-up|fMRI data from a total of 26 depressed participants randomized to receive CBT and 24 control participants was analyzed. The primary aim was to compare depressed and control participants to evaluate regional brain activation during an emotional task, both at baseline and 8-week follow-up. The primary regions analyzed were the amygdala and DLPFC.|||Voxels||Standard Deviation|Mean
2728866|NCT01027468|Secondary|Systemic Complications After Treatment||3 years after initial bevacizumab treatment||||participants|||Number
2728867|NCT01027468|Primary|CRT (Central Retinal Thickness)|Central retinal thickness measured in µm|3 years after initial intravitreal bevacizumab treatment||||µm||Standard Deviation|Mean
2728868|NCT01027468|Primary|Vision|Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis|3 years after first intravitreal bevacizumab treatment||||logMAR||Standard Deviation|Mean
2728869|NCT01027416|Secondary|Total Number of Over-expressed Genes, Across All Participants With Tumor Protein p53-wild Type Breast Tumors That Had RNA Samples Available.|Total number of over-expressed genes, across all participants with tumor protein p53-wild type breast tumors that had ribonucleic acid (RNA) samples available.|2 years|All patients with p53-wild type breast tumors that had RNA samples available|||genes|||Number
2728870|NCT01027416|Primary|Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm|Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm|2 years|All patients with p53-wild type breast tumors|||percentage of positive PLA||Standard Deviation|Mean
2728871|NCT01027364|Primary|Comparison of Annualized Bleeding Rates|Estimated with a factor for arm, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.|||episodes per participant per year||95% Confidence Interval|Number
2728872|NCT01027364|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed pharmacokinetic (PK) sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.|||episodes per participant per year||Inter-Quartile Range|Median
2728873|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in D-dimer|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.|||ng/mL||Standard Deviation|Mean
2728874|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Thrombin-antithrombin (TAT) Complex|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.|||ng/mL||Standard Deviation|Mean
2728875|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Prothrombin Split Fragments 1+ 2 (F 1+2)|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.|||pmol/L||Standard Deviation|Mean
2730728|NCT01012414|Primary|Change in High Sensitivity-C Reactive Protein (Serum)||1 year|Data were not collected when study was stopped prematurely.||||||
2728876|NCT01027364|Secondary|Number of Participants With Clinically Relevant Abnormalities or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFIXFc dose. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; a table was not generated for participants in the perioperative management/surgical arm (Arm 4). n=participants with a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, SBP, and DBP.|||participants|||Number
2728877|NCT01027364|Secondary|Time to 1% and 3% FIX Activity|Time to reach 1 or 3 IU/dL (%) after a single dose. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||days||95% Confidence Interval|Geometric Mean
2728878|NCT01027364|Secondary|Incremental Recovery|IU/dL rise in plasma per IU/kg drug administered. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2728879|NCT01027364|Secondary|Volume in Steady State (Vss)|Volume of distribution at steady state. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||mL/kg||95% Confidence Interval|Geometric Mean
2728880|NCT01027364|Secondary|Mean Residence Time (MRT)|The average time for all the drug molecules to reside in the body. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||hours||95% Confidence Interval|Geometric Mean
2728881|NCT01027364|Secondary|Clearance (CL)|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2728882|NCT01027364|Secondary|Half Life (t1/2) Alpha and t1/2 Beta|Time required for the concentration of the drug to reach half of its original value. Alpha and beta half-life indicate distribution and elimination half-life in a two-compartment PK model. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||hours||95% Confidence Interval|Geometric Mean
2728883|NCT01027364|Secondary|Area Under the Curve (AUC) Per Dose|Dose normalized area under the drug concentration-time curve. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2728884|NCT01027364|Secondary|Maximum Concentration (Cmax)|Maximum concentration during a dosing interval. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||IU/dL||95% Confidence Interval|Geometric Mean
2728885|NCT01027364|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||surgeries|Major Surgeries||Number
2728886|NCT01027364|Primary|Incidence Rate of FIX Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% CI were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFIXFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFIXFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of of rFIXFc and who had a valid inhibitor test; n=number of participants with given number of exposure days who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
2728887|NCT01027364|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||mL|Major Surgeries|Full Range|Median
2728888|NCT01027364|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||IU/kg|Major Surgeries|Full Range|Median
2728889|NCT01027364|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes including the loading dose to the end date/time of surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||injections|Major Surgeries|Full Range|Median
2728890|NCT01027364|Secondary|Investigators'/Surgeons' Assessment of Participants' Response to rFIXFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||responses|Major Surgeries||Number
2728891|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 26 and Week 52|The Haemo-QoL, a quality of life (QoL) assessment instrument for children and adolescents with hemophilia, was administered to participants from 13- to 17-years-old. This instrument assesses domains specific to living with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline, Week 26, Week 52|No summary analysis was done for this outcome measure due to the small number of participants completing the questionnaire.||||||
2750534|NCT00871845|Primary|Body Weight Loss|Mean weight change from week 0 to week 12|Weight loss as of Week 12||||kg||Standard Deviation|Mean
2728892|NCT01027364|Secondary|Haem-A-QoL Questionnaire for Adults: Change From Baseline to Week 52|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 52|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
2728893|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 26|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 26|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
2728894|NCT01027364|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.|||IU/kg||Inter-Quartile Range|Median
2728895|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had evaluable efficacy assessments; n=total number of bleeds at given location.|||injections||Inter-Quartile Range|Median
2728896|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had at least 1 bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
2728897|NCT01027364|Secondary|Number of Days From Last Injection to Treat a New Bleeding Episode|Please see the definition of the Efficacy Period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (bleeding episodes of this type were not evaluable). The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time. The number of days from the last injection to treat a bleed to a new bleeding episode was analyzed across all evaluable bleeding episodes per participant.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and at least 1 evaluable bleeding episode.|||days|Evaluable Bleeding Episodes|Inter-Quartile Range|Median
2729019|NCT01026805|Secondary|Fluid Deficit Per Procedure|mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.|at time of treatment||||mL||Full Range|Mean
2728898|NCT01027364|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.|||episodes per participant per year||Inter-Quartile Range|Median
2728899|NCT01027364|Secondary|Annualized Bleeding Rate by Type of Bleed (Spontaneous and Traumatic)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.|||episodes per participant per year||Inter-Quartile Range|Median
2728900|NCT01027364|Secondary|Average Dosing Interval For the Individualized Interval Prophylaxis Arm|Average dosing interval = sum of days in the included dosing intervals divided by the number of included intervals. Participants could have multiple prophylactic dose interval changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 2 who received at least 1 dose of rFIXFc with >=6 months on study and evaluable data.|||days||Inter-Quartile Range|Median
2728901|NCT01027364|Secondary|Average Weekly Dose For the Fixed Weekly Interval Prophylaxis Arm|Average weekly dose = (total IU/kg of all eligible prophylactic doses in the included intervals / total number of days in the included intervals)*7. Eligible dose = the first of the 2 doses defining the interval. Participants could have multiple prophylactic dose changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 1, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 1 who received at least 1 dose of rFIXFc with evaluable data. 'Overall' n=participants with evaluable data; 'Last 3 Months on Study' n=participants with evaluable data and >=6 months on study.|||IU/kg||Standard Deviation|Mean
2728902|NCT01027364|Secondary|Annualized rFIXFc Consumption Per Participant|Consumption is calculated for the efficacy period (EP). In Arms 1 and 2, the EP started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. Overall units (IU/kg) of annualized rFIXFc consumption = [Total rFIXFc IU/kg received during the EP / number of days in EP]*365.25.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data in the efficacy period. 'Overall' n=all participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=all participants in the Full Analysis Set with evaluable data and >=6 months on study.|||IU/kg rFIXFc per participant per year||Standard Deviation|Mean
2728903|NCT01027364|Secondary|Physicians' Global Assessments of Participants' Response to Treatment With rFIXFc|Physicians assessed each participant's response to rFIXFc using a 4-point scale: excellent=bleeding episodes responded to less than or equal to the usual number of injections or less than or equal to the usual dose of rFIXFc, or the rate of breakthrough bleeding during prophylaxis was less than or equal to that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis or hemostatic control required additional agents. Percentage of the total count of scale responses for all participants is presented. Multiple responses per participant are counted.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had evaluable efficacy assessments, and had nonmissing observations at time point.|||percentage of responses|Responses||Number
2728912|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 & 42 months .|1 month after each booster/ vaccine dose|The analysis was done on the MITT population, booster response.|||AU/mL||95% Confidence Interval|Geometric Mean
2750580|NCT00871715|Secondary|As-Tex Sensory Index||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2728904|NCT01027364|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had a bleeding episode; participants with a non-evaluable bleeding episode are counted in the 'number of participants analyzed,' but not the percentages.|||percentage of responses|Bleeding Episodes||Number
2728905|NCT01027364|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period|SAE=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. TESAE=SAE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOC is abbreviated in the table: Injury, Poisoning, and Procedural (IPP).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).|||participants|Participants With At Least 1 TESAE||Number
2728906|NCT01027364|Primary|Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOCs are abbreviated in the table: Immune System (IS); Injury, Poisoning, and Procedural (IPP); Metabolism and Nutrition (MN); Musculoskeletal and Connective Tissue (MCT); Respiratory, Thoracic and Mediastinal (RTM); Skin and Subcutaneous Tissue (SST).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).|||participants|Participants With At Least 1 TEAE||Number
2728907|NCT01027364|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TE=event present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. Related=related, possibly related, and relationship missing. Data include AEs emergent during the surgical/rehabilitation period; AE data are included in each treatment arm only for the time each participant was enrolled in that arm.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details). Participants with at least one TESAE reported are included in the TEAE count.|||participants|||Number
2728908|NCT01027364|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint. ULN=upper limit of normal.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; n=the number of participants with at least one post-baseline value. For this study, a table was not generated for potentially clinically significant laboratory abnormalities for participants in the perioperative management/surgical arm (Arm 4).|||participants|||Number
2728909|NCT01027351|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.|The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 & 42 months or 60 & 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after any vaccination|Analysis was done on the MITT – Two Dose Catch Up Schedule population.|||Number of subjects|||Number
2728910|NCT01027351|Secondary|Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.|The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population population.|||AU/mL||95% Confidence Interval|Geometric Mean
2752214|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||Baseline|||||||
2728913|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post booster; 1 month post dose for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||AU/mL||95% Confidence Interval|Geometric Mean
2728914|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measure using ELISA."|28 months after last Men B vaccination; baseline for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||AU/mL||95% Confidence Interval|Geometric Mean
2728915|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after last Men B vaccination; Baseline for Naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||AU/mL||95% Confidence Interval|Geometric Mean
2728916|NCT01027351|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.|The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.|||Percentage of subjects||95% Confidence Interval|Number
2728917|NCT01027351|Secondary|Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.|The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.|||Titers||95% Confidence Interval|Geometric Mean
2728918|NCT01027351|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.|The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|The analysis was done on the MITT population, 2-dose catch-up regimen.|||percentage of subjects||95% Confidence Interval|Number
2728919|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.|The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.|||Titers||95% Confidence Interval|Geometric Mean
2728920|NCT01027351|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post -vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.|||Percentages of subjects||95% Confidence Interval|Number
2728921|NCT01027351|Secondary|Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.|||Percentages of subjects||95% Confidence Interval|Number
2728922|NCT01027351|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.|||Percentages of subjects||95% Confidence Interval|Number
2728923|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.|||Titers||95% Confidence Interval|Geometric Mean
2728935|NCT01027286|Secondary|Daily Narcotic Usage (Morphine-equivalent mg)||daily during hospital stay (an expected average of 4 days)||||morphine-equivalent mg||Standard Deviation|Mean
2728936|NCT01027286|Secondary|Preoperative & Postoperative Hemoglobin Values||within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)||||g/dL||Standard Deviation|Mean
2728937|NCT01027286|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)||||participants|||Number
2728924|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|"The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.~Baseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study."|1 month post - booster/ -dose 1 for Naïve|The analysis was done on the MITT population, booster response.|||Percentage of subjects||95% Confidence Interval|Number
2728925|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.|||Percentage of subjects||95% Confidence Interval|Number
2728926|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.|||Titers||95% Confidence Interval|Geometric Mean
2728927|NCT01027351|Secondary|Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.|The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.|28 months after vaccination; baseline for naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||percentage of subjects||95% Confidence Interval|Number
2728928|NCT01027351|Secondary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.|Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after vaccination; Baseline for Naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||Titers||95% Confidence Interval|Geometric Mean
2728929|NCT01027351|Primary|Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.|The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after booster vaccination|Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data.|||participants|||Number
2728930|NCT01027351|Primary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.|"The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after last vaccination; baseline for naïve|The analysis was done on the MITT , 40 months of age, antibody persistence population.|||Percentages of subjects||95% Confidence Interval|Number
2728931|NCT01027351|Primary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.|Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after last vaccination; Baseline for Naïve|The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.|||Titers||95% Confidence Interval|Geometric Mean
2728932|NCT01027286|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|A scoring system used to evaluate the patient's opinion about his/her knee and associated problems. Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale. Subscale scores are generally not combined; rather, they are reported separated. Higher values represent better outcomes (i.e., less extreme symptoms).|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)|||points on a scale||Standard Deviation|Mean
2728933|NCT01027286|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)|||points on a scale||Standard Deviation|Mean
2728934|NCT01027286|Secondary|Length of Stay||day of hospital discharge||||days||Standard Deviation|Mean
2728938|NCT01027286|Secondary|Total Calculated Hospital Blood Loss||daily during hospital stay (an expected average of 4 days)||||mL||Standard Deviation|Mean
2728940|NCT01027273|Secondary|Emotional Health|Number of participants diagnosed as depressed utilizing depression scale. Participant is determined to be depressed if Patient Health Questionnaire (PHQ8) ≥ 10. Scale has a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.|6 months post enrollment into trial||||participants|||Number
2728941|NCT01027273|Secondary|Medication Adherence|"Number of participants adherent to medications as determined with Morisky score ≥ 6 Adherence to medications was measured using the 8-item Morisky Medication Adherence Questionnaire (Morisky). The questionnaire has been validated against an objective measure of adherence and has been used in racially diverse and elderly patient samples. Scores on the questionnaire can be used to classify patients into low and high adherence groups.~Consistent with standard cut points, participants who scored less than 6 points on the Morisky were categorized as nonadherent to medications and participants who scored 6 to 8 points were categorized as adherent."|6 months post enrollment into trial||||participants|||Number
2728942|NCT01027273|Secondary|Knowledge and Attitudes About Stroke Recurrence Risk||6 months post enrollment into trial|||||||
2728943|NCT01027273|Primary|Use of Anti-thrombotic Medication|Number of participants taking anti-thrombotic medication|6 months post enrollment into trial||||participants|||Number
2728944|NCT01027273|Primary|LDL Cholesterol|Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL|6 months post enrollment into trial||||percentage of participants|||Number
2728945|NCT01027273|Primary|Blood Pressure|Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg|6 months post enrollment into trial||||percentage of participants|||Number
2728946|NCT01027195|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery||||points on a scale||Standard Deviation|Mean
2728947|NCT01027195|Secondary|Harris Hip Score (Outcome Score)|A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery||||points on a scale||Standard Deviation|Mean
2728948|NCT01027195|Secondary|Length of Stay||day of hospital discharge||||days||Standard Deviation|Mean
2728949|NCT01027195|Secondary|Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay|Sum of daily morphine-equivalent mg narcotic usage during hospital stay.|daily during hospital stay (an expected average of 4 days)||||total morphine-equivalent mg||Standard Deviation|Mean
2728950|NCT01027195|Secondary|Change in Hemoglobin Level|Change in hemoglobin level from baseline to the day of hospital discharge.|within 30 days before surgery (preop), day of hospital discharge||||g/dL||Standard Deviation|Mean
2728951|NCT01027195|Secondary|Estimated Blood Loss||Intraoperative (day of surgery)||||mL||Standard Deviation|Mean
2728952|NCT01027195|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)||||participants|||Number
2728953|NCT01027195|Secondary|Number of Units Transfused||daily during hospital stay (an expected average of 4 days)||||units of blood||Standard Deviation|Mean
2728954|NCT01027000|Secondary|Chimerism for CD3||5 years post-registration|||||||
2728955|NCT01027000|Secondary|Overall Survival||5 years post-registration|||||||
2728956|NCT01027000|Secondary|Treatment-related Mortality||6 months post-transplant|||||||
2728957|NCT01027000|Secondary|Chronic GVHD||5 years post-registration|||||||
2728958|NCT01027000|Secondary|Acute Graft-vs-host Disease (GVHD)||5 years post-registration|||||||
2728959|NCT01027000|Secondary|Response||5 years post-registration|||||||
2728960|NCT01027000|Primary|2-year Progression-free Survival in Early Disease Participants|"Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A progression is defined as one of the following events:~>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= 2 cm); appearance of new palpable lymph nodes.~>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present.~> 50% increase in peripheral blood lymphocytes with an absolute increase > 5000/μL.~Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with >= 56% prolymphocytes)."|2 years post-registration|Participants with early disease stage were analyzed. Two participants, who did not start protocol therapy, were excluded from this analysis.|||percentage of participants||95% Confidence Interval|Median
2728961|NCT01026974|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age|The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after each vaccination|Analysis was done on the Safety population|||participants|||Number
2728962|NCT01026974|Secondary|Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post dose 2|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Geometric Mean
2729020|NCT01026805|Secondary|Fluid Volume Per Procedure|mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.|at time of treatment||||mL||Full Range|Mean
2728963|NCT01026974|Secondary|Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch-up dose of rMenB+OMV NZ in children at 40 months.|1 month post booster / 1 month post dose 1|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
2728964|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age.|18 months post vaccine dose 2|Analysis was done on MITT population|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
2728965|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40- & 42- months or 60- & 62- months of age are reported.|1 month post vaccine dose two|Analysis was done on the MITT population.|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
2728966|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age.|20 months post booster/ Baseline for Naïve|Analysis was done on MITT population.|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
2728967|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.|The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch-up dose of rMenB+ OMV NZ in children at 40 months.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
2728968|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after primary vaccination/ Baseline for Naïve|Analysis was done on MITT population.|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
2728969|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported.|18 months post vaccine dose two|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
2728970|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs.|18 months post vaccine dose 2|Analysis was done on the MITT population|||Titers||95% Confidence Interval|Geometric Mean
2728971|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
2728972|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The serum bactericidal antibody response in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported as GMTs.|1 month post vaccine dose two|Analysis was done on MITT population|||Titers||95% Confidence Interval|Geometric Mean
2728973|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age|The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported.|1 month post -vaccine dose two|Analysis was done on MITT population|||percentages||95% Confidence Interval|Number
2728974|NCT01026974|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age.|20 months post booster/ Baseline for Naïve|This analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
2728975|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine -naïve subjects of the same age and reported as GMTs.|20 months post booster/ Baseline for Naïve|Analysis was done on the MITT population|||Titers||95% Confidence Interval|Geometric Mean
2729021|NCT01026805|Secondary|Treatment Time Per Patient|mean morcellation(division into and removal of small pieces, as of tissue) time per patient|at time of treatment||||minutes||Full Range|Mean
2752215|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||Baseline|||||||
2728976|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|"The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.~Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive_4042 group."|1 month post booster / 1 month post dose 1 for Naïve|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
2728977|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age|The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.|1 month post-booster/ 1 month post-dose 1 for Naïve|Analysis was done on MITT population.|||percentages of subjects||95% Confidence Interval|Number
2728978|NCT01026974|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.|The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.|Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]|Analysis was done on the Safety population- defined as all subjects who received at least one Men B vaccination and provided post-baseline safety data.|||participants|||Number
2728979|NCT01026974|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.|"The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after primary vaccination; Baseline for Naïve|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
2728980|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population.|||Titers||95% Confidence Interval|Geometric Mean
2728981|NCT01026974|Primary|Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.|The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.|28 months after primary vaccination; Baseline for Naïve|Modified Intention-to-treat (MITT) population was defined as enrolled subjects who actually received at least one vaccine dose,and provided at least one evaluable serum sample both before and after baseline.|||Titers||95% Confidence Interval|Geometric Mean
2728982|NCT01026948|Secondary|Number of Participants Who Were Satisfied With Monitoring at Home|Maternal views were assessed by semi-structured diaries,recording women's ratings on a 4 point scale (very satisfied, satisfied, slightly disatisfied, very disatisfied)of how well they were coping and their satisfaction with outpatient experience.Women completed diaries at least once every two hours at home.Mean scores were calculated for women's ratings of coping, comfort satisfaction and location preference. An interpretive approach was utilised for all open responses. Comments made in the free-text spaces of diaries were categorised to contextualise women's ratings of their experience|6 months|51 women out 70 returned the semistructured diaries. All the diaries were assessed as explained above.|||participants|||Number
2728983|NCT01026948|Primary|Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.|Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.|6 months|70 women were recruited to the study, but 8 women were called back to the unit because of signal loss.|||participants|||Number
2728984|NCT01026909|Secondary|Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.||StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits||||steps/day||Standard Deviation|Mean
2728994|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 13.5|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 13.5|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.|||participants|||Number
2728995|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 9|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 9|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.|||participants|||Number
2728985|NCT01026909|Primary|Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.|"The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are:~Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best.~We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales."|This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.||||units on a scale||Standard Deviation|Mean
2728986|NCT01026844|Secondary|Correlate Epidermal Growth Factor Receptor (EGFR) Mutations and EGFR Amplification With Response to Treatment in Patients With Available Tumor Specimens.||2 years|Because so few responses were observed, this exploratory outcome was not analyzed||||||
2728987|NCT01026844|Secondary|Objective Tumor Response Rate|Number of Response Evaluation Criteria in Solid Tumors (RECIST) responses divided by number of patients treated. Per RECIST version 1.0 complete response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. The objective tumor response rate is the CR + PR divided by the total number of patients|2 years||||percentage of patients||95% Confidence Interval|Number
2728988|NCT01026844|Secondary|Determine the Pharmacokinetic (PK) Parameters of Hydroxychloroquine (HCQ) Plus Erlotinib.|PK parameter tested was dose normalized minimum steady state concentration (Cmin SS) of HCQ in micromolar per gram. Note this outcome was only analyzed for the first 21 patients enrolled, 13 on erlotinib/HCQ and 8 on HCQ arm.|2 years|The patients participating in the randomized portion of the study were analyzed for PK parameters. When the HCQ alone arm of the study was closed, PK measurements were no longer performed|||micromolar per gram||Standard Deviation|Mean
2728989|NCT01026844|Primary|Describe the Number and Type of Observed Dose Limiting Toxcities|HCQ doses tested included 400mg, 600mg, 800mg, and 1000mg. Dose-limiting toxicities (DLTs) were defined as CTC of grade 2 or higher retinopathy or keratitis, or CTC of grade 3 or higher hematologic, skin, CNS, neuropathic, cardiac, respiratory, gastrointestinal, or renal AEs in the first cycle considered at least possibly related to HCQ. If a DLT was observed, an additional three patients were enrolled at that dose level. The maximum tolerated dose for HCQ in each arm would be defined as one dose level below that at which two or more of 6 patients experienced a DLT, or if no DLTs were observed, the highest tested dose.|2 years|In October 2008, after enrollment of 18 patients (8 on arm A and 10 on arm B), the study was amended to limit enrollment to arm B only (HCQ plus erlotinib) given the increasing preclinical evidence supporting a role for combination therapy (but not HCQ monotherapy) and to help increase overall patient accrual.|||participants|||Number
2728990|NCT01026831|Other Pre-specified|Baseline IOP|IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).|Baseline|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.|||mmHg||95% Confidence Interval|Least Squares Mean
2728991|NCT01026831|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)|"IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).~IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12).~Lowering elevated IOP is a treatment goal of glaucoma."|Baseline, Weeks 2, 6, and 12.|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.|||mmHg||95% Confidence Interval|Least Squares Mean
2728992|NCT01026818|Secondary|Change in Penile Length and Girth|Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.|Randomization (Baseline), Month 9|All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.|||millimeter (mm)||95% Confidence Interval|Least Squares Mean
2728993|NCT01026818|Secondary|Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score|EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
2729016|NCT01026805|Secondary|Adverse Events|Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study|2-3 months post-treatment||||events|||Number
2728996|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 2|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 2|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2|||participants|||Number
2728997|NCT01026818|Secondary|Change From Baseline in 'Yes' Answers to Morning Erections|"The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of yes responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country."|Randomization (Baseline), Month 10.5|All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.|||"percentage of yes response"||95% Confidence Interval|Least Squares Mean
2728998|NCT01026818|Secondary|Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)|Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.|||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
2728999|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 13.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 13.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 13.5.|||participants|||Number
2729000|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 10.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 10.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 10.5.|||participants|||Number
2729001|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 9|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 9|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 9.|||participants|||Number
2729002|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 5.|||participants|||Number
2729003|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 2|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 2|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.|||participants|||Number
2729004|NCT01026818|Secondary|Residual Erectile Function (REF) at Baseline|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Baseline|All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.|||participants|||Number
2729005|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 13.5|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.|||participants|||Number
2729006|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 9|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.|||participants|||Number
2729007|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 1 at Month 13.5|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.|||participants|||Number
2729008|NCT01026818|Secondary|Global Assessment Questions (GAQ) Question 1 at Month 9|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.|||participants|||Number
2729009|NCT01026818|Secondary|Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score|The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
2729010|NCT01026818|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score|The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
2729011|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)|Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
2729012|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
2729013|NCT01026818|Secondary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 9 and Month 13.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.|||percentage of participants|||Number
2729014|NCT01026818|Primary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 10.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.|||percentage of participants|||Number
2729015|NCT01026805|Primary|Percentage of Tissue Removed|mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.|immediately post-treatment||||Percentage of tissue removed||Full Range|Mean
2729034|NCT01026454|Secondary|Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.||28 weeks|||||||
2752216|NCT00858689|Secondary|Stanford Binet 5 (SB5)||Baseline|||||||
2729022|NCT01026792|Primary|Objective Response Rate|Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1|Up to 3 years|Patients evaluable for response|||percentage of patients with response||95% Confidence Interval|Number
2729023|NCT01026623|Secondary|Rate of Adverse Events According to NCI CTCAE Version 4.0|"Adverse event summaries will be organized by body system, frequency of occurrence, intensity (ie, severity grade), and causality or attribution.~Please see Adverse Event/Serious Adverse Event Section."|Up to 4 weeks after completion of study treatment||||percentage of participants affected|||Number
2729024|NCT01026623|Secondary|Progression-free Survival|"Summarized using descriptive statistics. Median PFS over time will be determined using Kaplan Meier method.~This Outcome Measure was related to the Phase 2 portion of the study, which did not occur.~Therefore, there is no data to report."|From the time of first dose until objective tumor progression or death, assessed up to 4 weeks after completion of study treatment|All patients had withdrawn from study prior to data analysis.||||||
2729025|NCT01026623|Secondary|Maximal Percentage Change in Serum PSA as Compared to Week 12 Versus Baseline|"Summarized using descriptive statistics (eg, mean, standard deviation, median, minimum, maximum).~Maximum percent change in serum PSA (i.e., 100%*[(value at Week 12 minus value at baseline)/value at baseline])"|From baseline to week 12||||percentage change in Serum PSA||95% Confidence Interval|Median
2729026|NCT01026623|Secondary|Duration of Effect|Summarized using descriptive statistics.|From the time of first dose until the time of progression, assessed up to 4 weeks after completion of study treatment||||weeks||95% Confidence Interval|Median
2729027|NCT01026623|Secondary|Change in PSA Doubling Time|Compared using descriptive statistics. PSA doubling time is defined as the number of months it would take for PSA to increase two-fold. PSADT is inversely proportional to the slope of the regression line for the relation between log PSA and time. If this slope is negative, so the patient's PSA is going down over time, then the PSADT is negative.|Week 1, Week 5, Week 9, Week 13, Week 17, Week 21 and Week 25|Outcome not calculated. PSA decline from baseline and imaging response (at twelve weeks) instead which are recognized PCWG3 endpoints for metastatic castration resistant disease was the outcome.||||||
2729028|NCT01026623|Primary|Tumor Response Rate|Defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) and/or the proportion of patients who achieve a greater than 50% reduction in serum PSA compared to baseline.|Up to 4 weeks after completion of study treatment||||Participants|||Count of Participants
2729029|NCT01026623|Primary|cTTP|"Defined as the time from the first day of treatment to the earliest one of the following: tumor progression by RECIST; unequivocal evidence of progression by bone scan (at least two new lesions with confirmation at subsequent imaging); new skeletal events; symptomatic progression; or other clinical events attributable to prostate cancer that necessitate major interventions.~This Outcome Measure is related to the Phase II portion of the Trial, which did not occur.~Therefore, there is no data to report."|Up to 4 weeks after completion of study treatment|"All patients had withdrawn from study prior to data analysis. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur.~Therefore, there is no data to report."||||||
2729030|NCT01026493|Secondary|Phase II: Overall Survival (OS)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)|Eligible patients|||months||95% Confidence Interval|Median
2729031|NCT01026493|Secondary|Phase II: Objective Response (Partial and Complete Response) Rate for Patients With Measurable Disease After Surgery|Response and progression will be evaluated using standard criteria for patients with malignant gliomas (Macdonald 1990). Partial response and complete response are centrally reviewed.|Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)|Eligible patients with at least one cycle of treatment|||percentage of participants||95% Confidence Interval|Number
2729032|NCT01026493|Primary|Phase II: 6-month Progression-free Survival (PFS) Rate for Patients With Measurable Disease After Surgery|For patients with measureable disease after surgery: Progression defined as ≥ 25% increase in size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable/increased. Bevacizumab (BEV)-naïve group: p0= 15% as estimate of 6-mo. PFS [null hypothesis (NH)], p1= 30%, with a 15% absolute increase [alternative hypothesis (AH)]. Error rates of 10% alpha and 10% beta. If <= 11 patients experience 6-month PFS of the first 53 analyzable patients, then do not reject the null hypothesis that the 6-month PFS rate of experimental arm is less than 15%; BEV-failure group: p0 = 2% as a conservative estimate of 6-month PFS [NH], p1 = 15%, with a 13% absolute increase [AH]. Using first 26 analyzable subjects for each experimental arm, there is >= 90% power to detect >= 15% increase at a significance level of 0.10, using a 1-sided binomial test. If >= 2 patients (8%) are progression free at 6 mo., then claim this regimen to be promising in the patient group.|Randomization to 6 months.|Randomized patients with measurable disease after surgery, at least one cycle of treatment, evaluable for 6 month PFS, and within the required sample size (i.e. the first 53 BEV-naive patients and the first 26 BEV-failure patients- the number of patients will be less than sample size if not enough patients meet the criteria).|||participants|||Number
2729033|NCT01026493|Primary|Phase 1: Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) = any of the following events within 1st 8 weeks of treatment attributable to study drugs: Any grade (gr) 3/4 thrombocytopenia, gr 4 anemia, gr 3 neutropenia with fever (>100.4). gr 4 neutropenia lasting > 7 days; Any non-hematologic (NH) gr 3+ toxicity (TOX), excluding alopecia, despite maximal medical therapy (MLT); NH TOX such as rash, nausea, vomiting, diarrhea, mucositis, hypophosphatemia, and hypertension will only be considered DLTs if they remain gr 3+ despite MLT; 2nd occurrence of thromboembolism; Failure to recover from TOX (<= gr 1) to be eligible for re-treatment with study drugs <= 14 days of last dose of either drug; Any episode of non-infectious radiologically observed pneumonitis gr 2-4 any duration. Dose level will be considered acceptable if <= 1 of the 1st 6 eligible patients experiences a DLT. If current level is considered acceptable, dose escalation occurs. Otherwise preceding acceptable dose level will be declared the MTD.|Start of treatment to 8 weeks.|Eligible patients who started study treatment|||participants|||Number
2729035|NCT01026454|Primary|Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.|Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.|Weekly for 12 weeks per intervention||||log10 copies/mL||95% Confidence Interval|Mean
2729036|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 2|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set|||Participants|||Number
2729037|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 1|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set|||Participants|||Number
2729038|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 2|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set|||Participants|||Number
2729039|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 1|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set|||Participants|||Number
2729040|NCT01026402|Secondary|Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose|Phosphorylation levels of AKT from PRP (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set|||Percent change||Full Range|Median
2729041|NCT01026402|Secondary|Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose|Phosphorylation levels of 4EBP1 from peripheral blood mononuclear cell (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set|||Percent change||Full Range|Median
2729042|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) at Steady State|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set|||L/h||Standard Deviation|Mean
2729043|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) Single Dose|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set|||L/h||Standard Deviation|Mean
2729044|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State|Fraction dose excreted unchanged in the urine from 0-12 hours after dosing (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK|||Percent concentration||Standard Deviation|Mean
2729045|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose|Fraction dose excreted unchanged in the urine from 0-12 hours after a single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 12 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK|||Percent concentration||Standard Deviation|Mean
2729046|NCT01026402|Secondary|Area Under the Curve (AUC) at Steady State|AUC at steady state Continuous dosing - AUCss used Intermittent dosing - Weekly AUC used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2729047|NCT01026402|Secondary|Maximum Concentration (Cmax) at Steady State|Cmax at steady state (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729048|NCT01026402|Secondary|Area Under the Curve (AUC) Single Dose|Area under the curve following single dose Continuous dosing - AUC parameter used Intermittent dosing - AUC(0-12) used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2729065|NCT01026220|Secondary|Event Free Survival|Survival from enrollment to first event: relapse/progression, second malignancy, or death.|At 3 years from enrollment|164 Group 1 All Patients received induction therapy.|||Probability of survival||95% Confidence Interval|Number
2752217|NCT00858689|Secondary|Clinical Global Impression Scale||Baseline|||||||
2729049|NCT01026402|Secondary|Maximum Concentration (Cmax) Single Dose|Maximum concentration following single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729050|NCT01026402|Secondary|Best Objective Response|Best Objective Response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST) 1.1 for target and non target lesions assessed by CT, MRI or X-ray; Complete Response (CR), Disappearance of all target lesions since baseline; Partial Response (PR), At least a 30 percent decrease in the sum of diameters of target lesions; Progressive Disease (PD), At least a 20 percent increase in the sum of diameters of target lesions and an absolute increase of at least 5mm|Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months|Efficacy analysis set - Patients who received at least 1 dose of AZD2014 and have a baseline tumour assessment|||Participants|||Number
2729051|NCT01026402|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in >1 patient|Up to 21 days from first multiple dose|Safety Analysis Set - All patients that received at least 1 dose of AZD2014. This includes dosed patients who are not evaluable for dose escalation decision purposes.|||Participants|||Number
2729052|NCT01026389|Secondary|Sensitivity|sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).|up to one month|Per protocol population|||positive segment with MRA|Participants||Number
2729053|NCT01026389|Secondary|Specificity|Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).|up to one month|per protocol population|||negative segments in MRA|Participants||Number
2729054|NCT01026389|Secondary|Intra-patient Accuracy, in Off-site Readings|• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion|up to one month|"Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice.~Per protocol population"|||percentage of agreement|Participants|Standard Deviation|Mean
2729055|NCT01026389|Primary|Intra-patient Accuracy (Percent Agreement), On-site Data|intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.|up to one month|Per protocol population|||percentage of agreement||Standard Deviation|Mean
2729056|NCT01026324|Secondary|Progression-free Survival||Up to 6 months||||participants|||Number
2729057|NCT01026324|Primary|Percentage of Patients Alive (Phase II)|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II|Up to 1 year|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II||||||
2729058|NCT01026324|Primary|Recommended Phase-2 Dose of SCH727965|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.|14 days|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.||||||
2729059|NCT01026220|Secondary|Overall Survival|Survival from enrollment to death.|At 3 years from enrollment|164 Group 1 All Patients received induction therapy. 161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.|||Probability of survival||95% Confidence Interval|Number
2729060|NCT01026220|Secondary|Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy|The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.|During and after completion of study treatment.|165 eligible patients.|||participants|||Number
2729061|NCT01026220|Secondary|Event Free Survival|Survival from enrollment to first event: relapse/progression, second malignancy, or death.|At 3 years from enrollment|161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.|||Probability of survival||95% Confidence Interval|Number
2729062|NCT01026220|Secondary|Relapse-free Survival|A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.|3 years from enrollment|161 patients began consolidation therapy: 126 patients received risk-adapted radiotherapy after consolidation therapy ABVE-PC and 35 did not.|||Probability of survival||95% Confidence Interval|Number
2729063|NCT01026220|Secondary|Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative|To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.|3 years from enrollment|RER with positive PET-1, Event-Free Survival for RER PET-1 positive patients is compared to that of RER with negative PET-1: n=57 PET-1 positive RER patients, compared to 2 events among n=20 PET-1 negative RER patients. Two PET-1 equivocal RER patients (1 with relapse and 1 censored) are not included in this analysis.|||Probability of survival||95% Confidence Interval|Number
2729064|NCT01026220|Secondary|Second-event-free Survival|Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.|At 4 years from enrollment|This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).|||Probability of survival||95% Confidence Interval|Number
2729066|NCT01026220|Primary|Safety Analysis and Monitoring of Toxic Death|The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.|Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).|The six patients who received induction and reported death. The analysis here examines whether their death is primarily attributable to treatment or not.|||participants|||Number
2729067|NCT01026220|Primary|Second-event-free Survival|Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.|At 4 years from enrollment|This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).|||Probability of survival||95% Confidence Interval|Number
2729068|NCT01026194|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
2729069|NCT01026194|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*h / dL||Standard Error|Least Squares Mean
2729070|NCT01026194|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
2729071|NCT01026194|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||Percent of HbA1c||Standard Error|Least Squares Mean
2729072|NCT01026181|Primary|Change in BMI|"Patients' weight and height were measured at follow up visit 2 years post operation.~BMI was calculated using the formula: weight (kg)/height(meter)^2"|from baseline to 2-year postoperation||||kg/m^2||Standard Deviation|Mean
2729073|NCT01026181|Primary|Change in Body Weight|Change of body weight in Kilograms measured at follow-up visits two year after surgery|baseline to 2-year postoperation||||kg||Standard Deviation|Mean
2729074|NCT01026142|Secondary|Duration of Objective Response|Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).||||Weeks||95% Confidence Interval|Median
2729075|NCT01026142|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2729076|NCT01026142|Secondary|Overall Objective Response Rate (ORR)|Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.|||Percentage of participants|||Number
2729077|NCT01026142|Secondary|Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment|Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.|||Weeks||95% Confidence Interval|Median
2752218|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||Baseline|||||||
2729078|NCT01026142|Secondary|Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment|Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on IRF assessment.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.|||Weeks||95% Confidence Interval|Median
2729079|NCT01026142|Secondary|Investigator Assessment Progression-Free Survival (PFS)|Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 7.5 years).|All randomized participants.|||Months||95% Confidence Interval|Median
2729080|NCT01026142|Secondary|Overall Survival (OS) Rate Based on a 2-year Truncated Analysis|The Overall Survival (OS) 2-year truncated analysis is the Kaplan-Meier estimate of the percentage of participants who were surviving at 2 years. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.|From randomization until death from any cause (up to 2 years)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2729081|NCT01026142|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. The results of the final OS analysis are presented here. Participants who were alive or lost to follow-up at the time of the analysis were censored at the last known alive date. Participants with no postbaseline information were censored at the time of randomization plus 1 day. Prior to the final data analysis cut-off, it was ensured that all participants who were in survival follow-up had been contacted as recently as possible within the last 3 months to confirm current survival status.|From randomization until death from any cause (up to 7.5 years).|All randomized participants.|||Months||95% Confidence Interval|Median
2729082|NCT01026142|Primary|Progression Free Survival (Independent Assessment)|Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.|||months||95% Confidence Interval|Median
2729083|NCT01026103|Secondary|Incidence of Serosal Tearing||30 days post op||||participants|||Number
2729084|NCT01026103|Secondary|Length of Hospital Stay||Date of discharge which averages 3 days||||days||Standard Deviation|Mean
2729085|NCT01026103|Secondary|Incidence of Intra-operative Bleeding Requiring Intervention||Day 0 and 1 month||||participants|||Number
2729086|NCT01026103|Primary|Proportion of Patients With an Uneventful Creation of a Functional Staple Line||Day 0||||participants|||Number
2729087|NCT01026038|Post-Hoc|Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2729088|NCT01026038|Secondary|Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.|||Percentage of Participants||95% Confidence Interval|Number
2729089|NCT01026038|Secondary|Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.|||Percentage of Participants||95% Confidence Interval|Number
2729110|NCT01025817|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1|12 Months|Full Analysis Set (FAS) consisted of all patients randomized after transplantation|||mL/min/1.73m˄2||Standard Deviation|Mean
2729090|NCT01026038|Secondary|Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine|Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2729091|NCT01026038|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Up to 7 days before vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2729092|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Four to seven days after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2729093|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Up to 7 days before vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2729094|NCT01026038|Primary|Percentage of Participants With Prespecified Systemic Events|Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."|||Percentage of Participants|||Number
2729095|NCT01026038|Primary|Percentage of Participants With Prespecified Local Reactions|Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."|||Percentage of Participants|||Number
2729096|NCT01026038|Primary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine|Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2729097|NCT01026012|Primary|Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)|During and 30 minutes after stress test|Subjects whom completed the combined stress test, including imaging|||participants|||Number
2729098|NCT01025843|Secondary|Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.|||µmol/L||Standard Deviation|Mean
2729162|NCT01025284|Secondary|Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355||Day 3 of Cycle 1 (21-day cycle)|All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2729099|NCT01025843|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan|Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.|Baseline and 1 to 3 hours postdose|Results were not analyzed because none showed a > 5% decrease in AIx.||||||
2729100|NCT01025843|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.|||umol.hr/L||Standard Deviation|Mean
2729101|NCT01025843|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|Up to 24 hours after administration of study drug|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.|||Participants|||Number
2729102|NCT01025843|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|Up to 14 days after administration of last dose of study drug (up to Day 52)|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.|||Participants|||Number
2729103|NCT01025830|Secondary|Maximum Plasma Concentration of Drug|Maximum concentration of drug in plasma that was attained post dosing|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Intention to treat analysis used including only participants with sufficient plasma samples for analysis. Separate analyses are given for each drug. Results for this kind of study are not combined.|||milligram/liter||Standard Deviation|Geometric Mean
2729104|NCT01025830|Primary|Area Under the Concentration-Time Curve(AUC)|Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Analyzed population consists only of participants who had sufficient plasma samples for analysis.Intent to treat analysis was used. Separate analyses provided for each drug. Results of such a study are not combined.|||hour*milligram/liter||Standard Deviation|Geometric Mean
2729105|NCT01025817|Secondary|Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events|Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS|||Participants|Participants||Number
2729106|NCT01025817|Secondary|Number of Participants With Incidence of Proteinuria Events|Number of participants with Incidence of proteinuria events indicating chronic kidney disease|Baseline and 12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS|||Participants|Participants||Number
2729107|NCT01025817|Secondary|Number of Participants With Incidence of New Onset of Diabetes Mellitus|Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose ≥200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values ≥126 mg/dL (7 mmol/L)|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.|||Participants|Participants||Number
2729108|NCT01025817|Secondary|Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy|Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS|||Participants|Participants||Number
2729109|NCT01025817|Secondary|Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)|Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.|||Participants|Participants||Number
2729163|NCT01025284|Secondary|Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)||Days 1,5 and 9 of Cycle 1 (21-day cycle)|All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2729111|NCT01025817|Primary|Number of Participants With Incidence of Composite Efficacy Failure|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.|12 Months|Full Analysis Set (FAS) consisted of all participants randomized after transplantation|||Participants|Participants||Number
2729112|NCT01025791|Secondary|Time-Weighted Average of Heart Rate (0-12 Hours)|HR was measured with a validated automatic measuring device. Time weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.|Up to 12 hours|All participants who complied with the protocol sufficiently to ensure that their data likely exhibited the effects of treatment. Panel B MK-8266 0.4 mg fasted and Panel B MK-8266 0.4 mg fed were combined in the analysis. One participant in Panel B 1.2 mg + 0.6 mg did not receive the 1.2 mg dose and was not included in this analysis.|||Beats per Minute||Standard Error|Least Squares Mean
2729113|NCT01025791|Secondary|Effect of Food on MK-8266 PK Parameter Cmax Following Administration of Single Oral Doses of MK-8266 at 0.4 mg to Healthy Male Participants|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Fed Group was administered a high fat meal.|Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose|All participants who complied with the protocol sufficiently to ensure that their data likely exhibited the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2729114|NCT01025791|Secondary|Effect of Food on MK-8266 PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24hr) Following Administration of Single Oral Doses of MK-8266 at 0.4 mg to Healthy Male Participants|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-24 hours] is a measure of the mean concentration levels of drug in the plasma after the dose. The Fed Group was administered a high fat meal.|Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 postdose|All participants who complied with the protocol sufficiently to ensure that their data likely exhibited the effects of treatment, according to the underlying scientific model.|||nM·hr||95% Confidence Interval|Geometric Least Squares Mean
2729115|NCT01025791|Primary|MK-8266 PK Parameter Apparent t1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. Harmonic means +/- Pseudo standard deviations are displayed. t1/2 was not collected, analyzed or summarized for participants receiving placebo.|Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose|t1/2 was not estimated at MK-8266 doses below 1 mg and for the first 2 doses in Panel C due to the lack of measureable concentrations and for participants receiving placebo. One participant in Panel B 1.2 mg + 0.6 mg did not receive the 1.2 mg dose and was not included in this analysis.|||Hours||Standard Deviation|Mean
2729116|NCT01025791|Primary|MK-8266 PK Parameter Observed Time to Reach Cmax (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. Tmax was not collected, analyzed or summarized for participants receiving placebo.|Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose|The analysis population consisted of participants who complied with the protocol sufficiently to ensure that their data likely exhibited the effects of treatment. Tmax was not estimated for participants receiving placebo. One participant in Panel B 1.2 mg + 0.6 mg did not receive the 1.2 mg dose and was not included in this analysis.|||Hours||Full Range|Median
2729117|NCT01025791|Primary|MK-8266 PK Parameter Observed Maximum (Peak) Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. For Panel A 1.0/0.8 mg MK-8266, the second dose was not well characterized due to limited sampling. Observed exposure likely underestimates the true exposure. Cmax was not collected, analyzed or summarized for participants receiving placebo.|Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose|All participants who complied with the protocol sufficiently to ensure that their data likely exhibited the effects of treatment, according to the underlying scientific model. Cmax was not estimated for participants receiving placebo. One participant in Panel B 1.2 mg + 0.6 mg did not receive the 1.2 mg dose and was not included in this analysis.|||nM||Standard Deviation|Mean
2729118|NCT01025791|Primary|MK-8266 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-inf] is a measure of the mean concentration levels of drug in the plasma after the dose. AUC[0-inf] was not collected, analyzed or summarized for participants receiving placebo.|Predose, 0.5, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours postdose|AUC[0-inf] was not estimated at MK-8266 doses <1.0 mg and for the first 2 doses in Panel C due to the lack of measureable concentrations, and for participants receiving placebo. One participant in Panel B 1.2 mg + 0.6 mg did not receive the 1.2 mg dose and was not included in this analysis.|||mg/mL*hr||Standard Deviation|Mean
2729128|NCT01025752|Primary|Change in Numeric Rating Scale of Pain Intensity|"An 11-point NRS for pain was administered to patients, with 0 representing No Pain and 10 representing Worst Possible Pain. Patients were asked to rate the level of pain that best represented their experience of worst pain, least pain and average pain over the past week. We computed the change from baseline."|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2731540|NCT01007110|Secondary|Cord Blood Phospholipids DHA|Newborn red blood cell phospholipids collected at birth.|Birth||||weight percent total fatty acids||Inter-Quartile Range|Median
2729119|NCT01025791|Primary|Aortic Augmentation Index - Time-Weighted Average 0-24 Hours|Central ascending aortic blood pressure augmentation index (AIx) is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. AIx can be measured non-invasively by radial tonometry using aplanation tonometry of radial artery with the SphygmoCor Pulse Wave Analysis System Guide (SphygmoCor system). AIx was performed at prestudy to ensure an adequate waveform can be obtained. At each time point, a minimum of 2 AIx were completed in an attempt to obtain 2 acceptable quality assessments. A time weighted average was calculated. AIx was adjusted for heart rate. A decrease in the AIx of ≥5 percentage is considered clinically meaningful. Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period. The 12-hour measurement was not collected (per protocol) in all periods of Panels A and B.|Predose, 1.5, 3, 12, and 24 hours postdose|All participants who complied with the protocol sufficiently to ensure that their data likely exhibited the effects of treatment. Panel B MK-8266 0.4 mg fasted and Panel B MK-8266 0.4 mg fed were combined in the analysis. One participant in Panel B 1.2 mg + 0.6 mg did not receive the 1.2 mg dose and was not included in this analysis.|||Percentage of central pulse pressure||Standard Deviation|Least Squares Mean
2729120|NCT01025791|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.|Up to 43 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2729121|NCT01025791|Primary|Number of Participants Who Experienced One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Participants in Arms/Groups in which MK-8266 or placebo was administered in more than one period were counted separately for each period.|Up to 14 days after administration of last dose of study drug in each study period (Up to 43 Days)|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2729122|NCT01025752|Secondary|Change in Pittsburgh Sleep Quality Index|The PSQI assess sleep quality, with lower scores indicating better sleep, range 0 to 21.We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2729123|NCT01025752|Secondary|Change in Beck Depression Inventory-II|Depressive symptom severity was assessed using the BDI-II, higher scores indicate more depressive symptomology, range 0-63. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2729124|NCT01025752|Secondary|Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale|The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2729125|NCT01025752|Secondary|Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale|The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2729126|NCT01025752|Secondary|Change in Roland Morris Disability Questionnaire|The RMDQ (Roland & Morris, 1983) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2729127|NCT01025752|Secondary|Change in Multidimensional Pain Inventory Interference Subscale|The interference subscale of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) assesses pain-related interference with quality of life. Scores ranging from 0-6, with higher scores indicating more interference. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
2729160|NCT01025284|Secondary|Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]||Day 3 of Cycle 1 (21-day cycle)|All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞).|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2729129|NCT01025635|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'.|At End of treatment (up to 12 weeks) (LOCF)||||Percentage of participants|||Number
2729130|NCT01025635|Secondary|Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||At End of treatment (up to 12 weeks) (LOCF)||||Percentage of Inflammatory lesions||Standard Deviation|Mean
2729131|NCT01025635|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||Baseline and End of treatment (up to 12 weeks) (LOCF)||||Inflammatory lesions||Standard Deviation|Mean
2729132|NCT01025635|Primary|Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At End of treatment (up to 12 weeks) (LOCF)||||Percentage of participants|||Number
2729133|NCT01025492|Primary|Apolipoprotein A-I Serum Concentration|Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo|12 weeks|The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled. Additionally, the study outcome measure/endpoint (Apolipoprotein A-I serum concentration) was not analyzed.||||||
2729134|NCT01025453|Secondary|Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.|Participant toxicities evaluated by CTCAE version 4.0|3 years||||Participants|||Count of Participants
2729135|NCT01025453|Secondary|Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year||||percentage of patients|||Number
2729136|NCT01025453|Secondary|Duration of Study Treatment for Participants With and Without BRAF Mutations||6 years|The analysis separated the participants into 2 groups (number of patients with BRAF V600E Mutation and number of patients without BRAF V600E Mutation)|||months||Full Range|Median
2729137|NCT01025453|Primary|Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years|7 participants were not evaluable because they came off treatment before the first radiographic scan for reasons other than progression of disease, including but not limited to excessive toxicity (n=1), withdrawal of consent (n=3), and seeing other treatment (n=1).|||Participants|||Count of Participants
2729138|NCT01025336|Primary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
2729139|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729140|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729161|NCT01025284|Secondary|Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]|Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated.|Days 1,5 and 9 of Cycle 1 (21-day cycle)|No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1.||||||
2729141|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729142|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729143|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729144|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729145|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729146|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729147|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729148|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729149|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
2729150|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2752219|NCT00858689|Primary|ABC Irritability Subtest Score|ABC (Aberrant behavior checklist) Irritability subtest score was used|1 year|||||||
2729151|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729152|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729153|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729154|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729155|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729156|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729157|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
2729158|NCT01025336|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
2729159|NCT01025284|Secondary|Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)|LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome).|Baseline and follow-up up to 104 weeks after the first dose of study drug|All participants who received at least 1 dose of study drug and had total LCSS and ASBI scores at baseline and follow-up in Part B.|||units on a scale||Standard Deviation|Mean
2729164|NCT01025284|Secondary|Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)|The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease up to 18.1 weeks|All participants who received at least 1 dose of study drug in Part B.|||percentage of participants||90% Confidence Interval|Number
2729165|NCT01025284|Secondary|Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)|Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease 99.6 weeks|All participants who received at least 1 dose of study drug in Part A.|||percentage of participants||90% Confidence Interval|Number
2729166|NCT01025284|Secondary|Part B: Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.|Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks|All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4.|||weeks||90% Confidence Interval|Median
2729167|NCT01025284|Secondary|Part A: Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.|Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks|All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4.|||weeks||90% Confidence Interval|Median
2729168|NCT01025284|Primary|Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)|Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease up to 18.1 weeks|All participants who received at least 1 dose of study drug in Part B.|||percentage of participants||90% Confidence Interval|Number
2729169|NCT01025284|Primary|Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)|The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease up to 99.6 weeks|All participants who received at least 1 dose of study drug in Part A.|||percentage of participants||90% Confidence Interval|Number
2729170|NCT01025271|Secondary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) to Determine the CSF Penetration and Pharmacokinetic Parameters in This Patient Population (|no analysis completed|5 years|||||||
2729171|NCT01025271|Primary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis|unable to meet enrollment no data available. Study terminated early|5 years|unable to meet enrollment no data available. Study terminated early||||||
2729172|NCT01025232|Secondary|Evaluate the Relationship Between Specific Genetic Polymorphisms Associated With AMD, Disease Characteristics and Processes, and Response to Intravitreal Ranibizumab||1 year|Given lack of clinical benefit of 2.0 mg ranibizumab, as demonstrated in the HARBOR trial [Busbee BG, et al. (2013) Ophthalmology 120(5), 1046-1056], further secondary analyses were suspended.||||||
2729173|NCT01025232|Secondary|Assess Number of Ranibizumab Injections in Each of the Two Doses Required Through Month 12||1 year||||number of injection||Standard Deviation|Mean
2729174|NCT01025232|Secondary|Evaluate Mean Change in Central Retinal Thickness Over Time Through Month12 as Assessed by All Three OCTs (Stratus, Cirrus, and Spectralis)||1 year||||micrometer||Standard Deviation|Mean
2729175|NCT01025232|Secondary|Determine Number of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12 in ETDRS BCVA.||1 year||||participants|||Number
2729176|NCT01025232|Secondary|Determine Number of Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12 and Month 12 in ETDRS BCVA||1 year||||participants|||Number
2729177|NCT01025232|Secondary|Evaluate the Incidence and Severity of Ocular and Non-ocular Adverse Events (AEs) Through Month 12||1 year||||Incidents|||Number
2729207|NCT01024686|Primary|Occurrence of Serious Adverse Events (SAE)||baseline through 28 days|(0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge.|||participants|||Number
2755434|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 8 postop||||percentage of blood volume||Standard Deviation|Mean
2729178|NCT01025232|Primary|Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.)|Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) was used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|1 Year||||ETDRS BCVA Letters||Standard Error|Mean
2729179|NCT01025193|Secondary|Number of Participants With Treatment Related Serious Adverse Events|To assess the safety of belimumab in sensitized patients awaiting kidney transplant we evaluated the number of participants with serious adverse events possibly or definitely related to belimumab.|up to one year pre-transplant|Any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
2729180|NCT01025193|Secondary|Hepatitis B Vaccine Antibody Titers|We investigated if belimumab treatment would decrease Hepatitis B vaccine titers by 12 months after treatment with belimumab. All patients received Hepatitis B vaccine before beginning treatment with belimumab.|up to 12 months of treatment with belimumab|All patients who received at least one dose of belimumab were included in the analysis|||Participants|||Count of Participants
2729181|NCT01025193|Secondary|BLyS Levels Before and After Treatment With Belimumab|We assessed for unexpected changes in bound and unbound BLyS levels before and after treatment with belimumab. These were measured from before treatment and at months 1,2,6,10 and 12 months after belimumab treatment and again at 8 weeks after belimumab treatment.|up to 8 weeks after completion of therapy|Any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
2729182|NCT01025193|Secondary|B and T Lymphocyte Subsets|B and T Lymphocyte subsets were measured through flow cytometry pre-treatment and at months 1,2,12 and at 8 weeks after the last belimumab dose. We looked for clinically significant changes (as determined by Principal Investigator) in these subsets at each time-point.|8 weeks after the last dose of belimumab|Any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
2729183|NCT01025193|Secondary|Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point.|We wanted to look at belimumab pharmacokinetics in sensitized patients awaiting kidney transplant. These are reported as number of participants with specific dilution factors at each studied time-point. Blood for these tests could be drawn pre dose as well as 0-4 hours after the dose was given. Belimumab dilutions factors were measured pre dose at timepoints 0 (first day of belimumab), days 56 and 364. Belimumab dilution factors were measured after the dose on days 14, and 168. Belimumab dilution factors were also measured at 8 weeks after completion of belimumab therapy and pre dose at any unscheduled visits if needed.|Belimumab serum drug dilution factors were measured in patients at at timepoints 0 (first day of belimumab), day 14, day 56, day 168, 364, at any unscheduled visits, and at 8 weeks post completion of belimumab therapy.|any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
2729184|NCT01025193|Primary|Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy)|In order for a sensitized recipient ( a recipient with antibodies) to be transplanted, the cross match with the donor has to be compatible. We wanted to study if belimumab reduced antibodies in sensitized patients and led those patients to subsequently become cross-match compatible with a donor and allow for successful transplant.|one year pre-transplant|All participants enrolled who received at least one dose of belimumab were considered for analysis.|||Participants|||Count of Participants
2729185|NCT01025193|Primary|Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation.|Before transplant it is necessary to measure antibodies that the recipient might have and compare them to the living or decease donor's immune make-up. Recipients with many antibodies or a specific antibody in a high concentration may have a more difficult time finding a compatible donor, and being transplanted. These recipients are referred to as sensitized patients. It is important that the sensitized recipient and the donor be compatible to prevent rejection after transplant. We measured antibodies levels in sensitized patients waiting for kidney transplant, to see if belimumab would decrease these antibody levels.|up to one year pre-transplant|any patient who received at least one dose of belimumab was included in analysis population|||Participants|||Count of Participants
2729186|NCT01025154|Primary|Median Event-Free Survival (EFS)|Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death. Bayesian time-to-event model will be used to monitor progression free survival.|2 years|Two of the fifty-nine participants were not included in the analysis.|||Months||Full Range|Median
2729187|NCT01025154|Primary|Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery|Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy.|8 weeks after Induction therapy (induction cycle 4-6 weeks)|Two of the fifty-nine participants were not evaluable.|||participants|||Number
2729188|NCT01025076|Primary|Primary Outcome: Change in Body Weight|Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.|At 6 months comparing to baseline weight||||kg||Standard Deviation|Mean
2729189|NCT01025037|Secondary|Isometric Strength||baseline, post-op months 6, 12, and 24||||newtons (N)||Standard Deviation|Mean
2729190|NCT01025037|Primary|Simple Shoulder Test (SST)|"The Simple Shoulder Test (SST): a series of 12 yes or no questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome."|baseline, post-op months 3, 6, 12, and 24||||units on a scale||Standard Deviation|Mean
2755435|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 5 postop||||percentage of blood volume||Standard Deviation|Mean
2729191|NCT01025037|Primary|Adjusted Constant-Murley Score|The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005).|baseline, post-op months 6, 12, and 24||||units on a scale||Standard Deviation|Mean
2729192|NCT01025037|Other Pre-specified|Incidence of Complications, Including Infection|Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.|All time points||||percentage of participants|||Number
2729193|NCT01025037|Secondary|Rotator Cuff Re-tear Evaluation|"Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.~Two different definitions of a re-tear were used for the analysis.~Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.~Sub-analysis: Full thickness tear one centimeter or greater in length."|Post-op months 6 and 12|Participants were analyzed at 6 and 12 months post-op. 2 participants not analyzed due to exclusion prior to 6 month post op visit.|||percentage of participants|||Number
2729194|NCT01025037|Primary|American Shoulder and Elbow Score (ASES)|The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.|baseline, post-op months 3, 6, 12, and 24||||units on a scale||Standard Deviation|Mean
2729195|NCT01024972|Secondary|In-hospital Mortality|Number of subjects who expired during hospitalization.|up to 90 days||||participants|||Number
2729196|NCT01024972|Secondary|Liver Toxicity|Number of subjects who developed liver toxicity as evidenced by Liver Function Test elevation greater than 5 times the upper limit of normal.|7 days||||participants|||Number
2729197|NCT01024972|Primary|Hyponatremia|Number of subjects who developed hyponatremia (sNa ≤132mmol/L)|Seven days||||participants|||Number
2729198|NCT01024959|Primary|Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)|The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score >=25 was positive, PCA3 Score <25 was negative|At the time of biopsy|A total of n=466 subjects have valid and reportable PCA3 Scores and disease status (determined by biopsy result), and who were 50 years of age or older.|||participants|||Number
2729199|NCT01024946|Primary|To Determine the Rate of Clinical Benefit (i.e. Rate of Complete or Partial Response Plus Stable Disease) at 16 Weeks for Patients With Malignant Mesothelioma Treated With Everolimus as Second or Third Line Therapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks||||participants|||Number
2729200|NCT01024855|Primary|Number of Eyes With No Change in Corneal Staining|Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.|Change from baseline after 1, 2, 4 and 6+ hours of wear|per protocol|||eyes|||Number
2729201|NCT01024751|Secondary|Slit Lamp Findings|Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.|Over all visits for 1 month|Greater than grade 2 for all dispensed eyes with non-missing scores|||eyes|Participants||Number
2729202|NCT01024751|Primary|Comfort-related Symptoms/Complaints|Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.|At dispensing visit and each follow-up visit at week 2 and week 4.|Summaries included all eligible, dispensed participants, with participants summarized under the study products received.|||Units on a scale|Participants|Standard Deviation|Mean
2729203|NCT01024738|Primary|Plaque Index|Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 Days||||Units on a scale||Standard Deviation|Mean
2729204|NCT01024686|Secondary|P. Falciparum Specific Cell-mediated Immune Responses||From administration of study vaccine through the duration of the trial|(0) data available because the clinical trial was terminated before DAY 90 blood draw for P. falciparum specific cell-mediated immune responses.||||||
2729205|NCT01024686|Secondary|Development of Parasitemia and Time to Parasitemia After Re-challenge Following Administration of GAP||From administration of study vaccine through the duration of the trial|(0) Participants because clinical study was terminated before enrollment for primary malaria challenge.||||||
2729206|NCT01024686|Secondary|Development of Parasitemia and Time to Parasitemia After Primary Malaria Challenge Following Administration of GAP||From administration of study vaccine through the duration of the trial|(0) Participants because clinical study was terminated before enrollment for primary malaria challenge||||||
2739100|NCT00957359|Secondary|QoL Physical Health Scale|4-20 (higher score improved quality of life domain)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2729208|NCT01024686|Primary|Detection of Breakthrough Peripheral Parasitemia by Thick Blood Film||From 7 days after administration of vaccine through 28 days (+ 4 days) post-dosing|(0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge.|||participants|||Number
2729209|NCT01024686|Primary|Occurrence of Laboratory Adverse Events (AE)|Volunteers with any laboratory abnormality.|From administration of study vaccine through 7 days (± 1 days) post dosing|(0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge|||Participants|||Count of Participants
2729210|NCT01024686|Primary|Occurrence of Unsolicited AEs||From administration of study vaccine through 28 days (± 4 days) post dosing|(0) Participants because clinical study was terminated before enrollment for Infectivity Control and p52-p36- GAP Vaccine + Infectivity Challenge.|||events|||Number
2729211|NCT01024686|Primary|Occurrence of Solicited Adverse Events (AE)||From administration of study vaccine through 7 days (± 1 days) post dosing|(0) Zero participants analyzed because the study was terminated prior to enrollment.|||events|||Number
2729212|NCT01024608|Secondary|Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period|"Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).~The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2729213|NCT01024608|Secondary|Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.|Day 0 (Baseline), Day 15|The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
2729214|NCT01024608|Secondary|Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2729215|NCT01024608|Primary|Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).~The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2729216|NCT01024569|Secondary|Quality of Life Brief Assessment|Quality of Life was assessed by the World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF). The 8-item environment sub-scale was utilized for our study. Respondents rate their experience of 8 quality indicators over the past 2 weeks using a 5-point Likert response scale. The minimum value is 8 and the maximum is 40, with higher scores meaning better outcomes.|Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)|The Overall Number of Participants Analyzed reflects the number of participants at Time 1|||Score on a Scale||Standard Deviation|Mean
2729217|NCT01024569|Primary|Recovery From Mental Illness|"This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from strongly disagree to strongly agree. The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms."|Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)|The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.|||score on a scale||Standard Deviation|Mean
2729218|NCT01024569|Primary|Patient Self-Advocacy|"The ability to advocate for oneself with medical care providers is assessed via self-report using The Patient Self-Advocacy Scale, an 18-item scale with a 5-point Likert response set ranging from strongly disagree to strongly agree. Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Values range from a minimum of 18 to a maximum of 90, with higher scores indicating a better outcome."|Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)|The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline|||Score on a Scale||Standard Error|Mean
2731937|NCT01004393|Secondary|Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
2729219|NCT01024569|Primary|Hopefulness|"Hopefulness is measured by the State Hope Scale. Hopefulness as a cross-situational long-term trait is assessed via patient self-report using a 12-item scale assessed on a 4-point Likert response scale with options ranging from definitely false to definitely true and summed to produce a total score and sub-scale scores. The minimum value for this scale is 12 and the maximum value is 48. Higher scores indicate a better income."|Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)|The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.|||Score on a Scale||Standard Deviation|Mean
2729220|NCT01024569|Primary|Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)|The BSI is a patient self-report mental health symptoms research instrument (Piersma et al., 1994). Respondents are asked how much they were bothered in the past week by 53 symptoms on 9 dimensions with a 5-point response scale ranging from ''not at all'' to ''extremely.'' We assessed the BSI Positive Symptom Score which captures the number of symptoms endorsed in a pathological direction, representing the total volume of different symptoms reported to be present to any degree. The minimum value is 0 and the maximum score is 212, where higher scores mean a worse outcome.|Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)||||symptom severity score||Standard Deviation|Mean
2729221|NCT01024465|Primary|Total Weight Loss|Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.|baseline to 180 days|Subjects with a weight recorded at 6 months|||kg||Standard Deviation|Mean
2729222|NCT01024387|Secondary|1-Year Overall Survival|Overall survival (OS) based on the Kaplan-Meier method is defined as the time from treatment start to the date of death or censored at the date last known alive. 1-year overall survival is the probability (%) of remaining alive 1 year from the start of treatment.|Patients in this study cohort were followed up to 20 months.|The analysis dataset is comprised of all enrolled patients.|||percent probability||95% Confidence Interval|Number
2729223|NCT01024387|Secondary|Progression Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from the start of treatment to the date of the first documented disease progression or death due to any cause. Patients without an event were censored at the earliest date of last disease assessment or initiation of non-protocol anti-cancer therapy. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months.|The analysis dataset is comprised of all PFS evaluable patients.|||months||95% Confidence Interval|Median
2729224|NCT01024387|Secondary|Grade 3-4 Toxicity Rate|Grade 3-4 toxicity rate is the percentage of patients who experienced a grade 3 or 4 adverse event with treatment attribution of possible, probable or definite based on CTCAEv4.|Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||95% Confidence Interval|Number
2729225|NCT01024387|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).|This endpoint was not evaluated because zero patients achieved objected response per RECIST criteria.||||||
2729226|NCT01024387|Primary|Objective Response Rate|Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).|The analysis dataset is comprised of all response evaluable patients.|||percentage of patients|||Number
2729227|NCT01024335|Primary|Retention|Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.|retention over 8 weeks.||||participants|||Number
2729228|NCT01024335|Primary|Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .|The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.|3x/week during 8 weeks of the trial or study participation||||units on a scale||Standard Deviation|Mean
2729229|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.|||units on a scale||Inter-Quartile Range|Median
2729230|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.|||units on a scale||Inter-Quartile Range|Median
2729231|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|6 week|A total of 54 participants returned for follow-up at 6 weeks. 3 participants did not complete the WOMAC in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||units on a scale||Inter-Quartile Range|Median
2729232|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).|6 week|54 participants returned for follow-up at 6 weeks. A total of 5 participants did not complete the Harris Hip Score instrument in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||units on a scale||Inter-Quartile Range|Median
2729233|NCT01024309|Secondary|Anteversion Angle|Anteversion angle is a radiographic measure of implant position. 35 degrees of anteversion is optimal. 25-45 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 35 degrees indicate better placement.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||degrees||Inter-Quartile Range|Median
2729234|NCT01024309|Secondary|Abduction Angle|Abduction angle is a radiographic measure of implant position. 40 degrees of abduction is optimal. 30-50 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 40 degrees indicate better placement.|6 wk|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||degrees||Inter-Quartile Range|Median
2729235|NCT01024309|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC)|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.|||units on a scale||Inter-Quartile Range|Median
2729236|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.|||units on a scale||Inter-Quartile Range|Median
2729294|NCT01023958|Secondary|Cmax of Volasertib|Maximum measured concentration in plasma (Cmax) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729237|NCT01024309|Primary|Number of Days for Discontinue Assistive Devices|The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||days||Inter-Quartile Range|Median
2729238|NCT01024296|Primary|Time of Port Site Closure||Day 1, from insertion to removal of Port Close device during surgery|Participants with successful closure using the Port Close device were included in the analysis.|||seconds||Standard Deviation|Mean
2729239|NCT01024296|Primary|Count of Participants With Successful Port Site Closure Using Port Close Device||Day 1, at the end of surgery||||Participants|||Count of Participants
2729240|NCT01024244|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||beats per minute (bpm)||Standard Deviation|Mean
2729241|NCT01024244|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes per 30 days|||Number
2729242|NCT01024244|Secondary|Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.|||nanograms per milliliter times hour||Standard Deviation|Mean
2729243|NCT01024244|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and the sparse sampling approach.|||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
2729244|NCT01024244|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|No participants had data analyzed due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
2729245|NCT01024244|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729246|NCT01024244|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729247|NCT01024244|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2755436|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 1 postop||||percentage of blood volume||Standard Deviation|Mean
2729248|NCT01024244|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks, Baseline through 16 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.|||percentage of participants|||Number
2729249|NCT01024244|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
2729250|NCT01024244|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
2729251|NCT01024244|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2729252|NCT01024244|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||kilograms (kg)||Standard Deviation|Mean
2729253|NCT01024244|Secondary|Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes|||Number
2729254|NCT01024244|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||mm Hg||Standard Deviation|Mean
2729255|NCT01024244|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729256|NCT01024244|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.|||millimoles per liter (mmoL/L)||Standard Deviation|Mean
2729295|NCT01023958|Secondary|AUC0-∞ of Volasertib|Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|Pharmacokinetic set (PKS) including patients with analyzable data for this endpoint.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2729257|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.|||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
2729258|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.|||percentage of beta cell function (%B)||Standard Deviation|Mean
2729259|NCT01024244|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.|||milliseconds (ms)||Standard Deviation|Mean
2729260|NCT01024244|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2729261|NCT01024036|Secondary|Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline|SF-36 is a questionnaire and PCS is a part of subscale assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
2729262|NCT01024036|Secondary|Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline|"The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from not at all (0) to very much (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes."|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
2729263|NCT01024036|Secondary|Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline|A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||Full Range|Median
2729264|NCT01024036|Secondary|6-year Survival Rate|Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed.|until 6 years|Safety Analysis set included all randomized participants who received at least 1 dose of study agent.|||Percent chance of survival||95% Confidence Interval|Median
2729265|NCT01024036|Secondary|Percentage of Participants Who Discontinued Corticosteroids|Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).|From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)|All randomized participants who were dependent on corticosteroids at baseline.|||Percentage of participants|||Number
2729266|NCT01024036|Secondary|Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)|Hemoglobin response rate is defined as percentage of participants who achieved >= 20 g/L hemoglobin at Week 13.|Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation.|||Percentage of participants|||Number
2729267|NCT01024036|Secondary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)|Hemoglobin response rate is defined as percentage of participants who achieved >= 15 g/L hemoglobin at Week 13.|Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation.|||Percentage of participants|||Number
2729296|NCT01023958|Secondary|Duration of Disease Control|Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first.|Time of first response to progression or death, up to 2 years|Patients who achieved disease control in the TS.|||Weeks||Full Range|Median
2729268|NCT01024036|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman's disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).|From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
2729269|NCT01024036|Secondary|Median Duration of Tumor Response - by Independent Radiology Review|Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)|All randomized participants who achieved tumor response during blinded treatment period as per independent review.|||Days||Full Range|Median
2729270|NCT01024036|Secondary|Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review|Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)|Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation.|||Percentage of participants|||Number
2729271|NCT01024036|Secondary|Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review|Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.|From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years)|All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review.|||Days||Full Range|Median
2729272|NCT01024036|Primary|Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review|Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants.|||Percentage of participants|||Number
2729273|NCT01024010|Secondary|Treatment-free Survival|Treatment-free survial is defined as the time from registration to the date of initiation of subsequent treatment for CLL or death due to any cause. The distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.|up to 5 years from registration||||months||95% Confidence Interval|Median
2729274|NCT01024010|Secondary|Depth of Response After Ofatumumab Consolidation|The proportion of patients with an improvement in depth of response with the addition of ofatumumab consolidation after PCO induction will be estimated by the number of patients with improvement in response from the time of response evaluation at the completion of PCO to the time of response evaluation at the completion of ofatumumab consolidation divided by the total number of evaluable patients. The hierarchy for depth of response will be in the following increasing order: SD, PR, nPR, CR/CRi with MRD+, CR/CRi with MRD-. An improvement in depth of response will be defined as an improvement of at least one level in the hierarchy. Exact binomial 95% confidence intervals for the true overall improvement rate will be calculated.|14 months|Thirty-one out of the 34 patients registered to Arm B: PCO+O began consolidation, 28 were evaluated for response at the end of consolidation treatment (3 patients did not return for response evaluation at the end of treatment).|||percentage of participants||95% Confidence Interval|Number
2729297|NCT01023958|Secondary|Disease Control Rate|Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD).|From first drug administration until end of study, up to 2 years|TS|||Percentage of participants||95% Confidence Interval|Number
2729298|NCT01023958|Secondary|Duration of Overall Response|The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first.|From the time of first response (CR or PR) to progression or death, up to 2 years|TS|||Weeks||Full Range|Median
2729275|NCT01024010|Secondary|Overall Response Rate|"The overall response rate will be estimated by the total number of complete or partial responses (CCR, CR, CRi, nPR, or PR) divided by the total number of evaluable patients. Responses will be evaluated using NCI Working Group criteria. Minimum requirements for a Partial Response (PR) requires:~50% decrease in peripheral blood lymphocyte count from the baseline~50% reduction in the sum of the products of the largest measured node or nodal masses on physical examination.~50% reduction in size of liver and/or spleen~50% improvement in neutrophils, platelets and hemoglobin"|14 months|All patients were evaluable for this endpoint.|||percentage of participants||95% Confidence Interval|Number
2729276|NCT01024010|Primary|Arm B: Treatment-free Survival at 18 Months|The primary endpoint Arm B: PCO+O is treatment-free survival rate at 18 months. An event for treatment-free survival will be defined as initiation of subsequent therapy for CLL or death due to any cause. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for event-free survival at 18 months. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.|18 months||||percentage of participants||95% Confidence Interval|Number
2729277|NCT01024010|Primary|Arm A: Percentage of Complete Responses|"In Arm A: PCO, the primary endpoint of this trial is the percentage of complete responses. The NCI Working Group criteria was used to assess response to therapy:~A Complete Response (CR) is briefly defines as the absence of lymphadenopathy, no heptomegaly nor splenomegaly, neutrophils greater than 1500/ul, platelets > 100,000/ul, hemoglobin >11.0 gm/dl, and peripheral blood lymphocytes <4000uL."|7 months|All patients that began Arm A protocol treatment were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2729278|NCT01023958|Secondary|Laboratory Investigation: Total Bilirubin|Difference from baseline in laboratory parameter total Bilirubin|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available total bilirubin data.|||umol/L||Standard Deviation|Mean
2729279|NCT01023958|Secondary|Laboratory Investigation: Creatinine|Difference from baseline in laboratory parameter Creatinine|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available creatinine data.|||umol/L||Standard Deviation|Mean
2729280|NCT01023958|Secondary|Laboratory Investigation: Alkaline Phosphatase|Difference from baseline in laboratory parameter Alkaline phosphatase|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available alkaline phosphate data.|||U/L||Standard Deviation|Mean
2729281|NCT01023958|Secondary|Laboratory Investigation: ALT/GPT, SGPT|Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available ALT/GPT, SGPT data.|||U/L||Standard Deviation|Mean
2729282|NCT01023958|Secondary|Laboratory Investigation: AST/GOT, SGOT|Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available AST/GOT, SGOT data.|||U/L||Standard Deviation|Mean
2729283|NCT01023958|Secondary|Laboratory Investigation: Lymphocytes|Difference from baseline in laboratory parameter Lymphocytes|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available lymphocytes data.|||10^9 cells/L||Standard Deviation|Mean
2729284|NCT01023958|Secondary|Laboratory Investigation: Neutrophils|Difference from baseline in laboratory parameter Neutrophils|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available neutrophils data.|||10^9 cells/L||Standard Deviation|Mean
2729285|NCT01023958|Secondary|Laboratory Investigation: Platelets|Difference from baseline in laboratory parameter Platelets|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available platelets data.|||10^9 cells/L||Standard Deviation|Mean
2729286|NCT01023958|Secondary|Laboratory Investigation: White Blood Cell Count|Difference from baseline in laboratory parameter white blood cell count|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available white blood cell count data.|||10^9 cells/L||Standard Deviation|Mean
2729287|NCT01023958|Secondary|Laboratory Investigation: Haemoglobin|Difference from baseline in laboratory parameter Haemoglobin|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available haemoglobin data.|||g/L||Standard Deviation|Mean
2729288|NCT01023958|Secondary|Occurrence of Unacceptable Toxicity|Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia.|From first drug administration up to 21 days after final administration, up to 2 years|TS|||Percentage of participants|||Number
2729289|NCT01023958|Secondary|Occurrence and Intensity of AE's Graded According to CTCAE|"Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)."|From first drug administration until end of study, up to 2 years|TS|||Percentage of participants|||Number
2729290|NCT01023958|Secondary|Tmax of Volasertib|Time from dosing to maximum measured concentration (Tmax) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||Hours||Full Range|Median
2729291|NCT01023958|Secondary|Vss of Volasertib|Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||Litres||Geometric Coefficient of Variation|Geometric Mean
2729292|NCT01023958|Secondary|CL of Volasertib|Total plasma clearance after intravascular administration (CL) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2729293|NCT01023958|Secondary|t1/2 of Volasertib|Terminal half-life (t1/2) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
2729299|NCT01023958|Secondary|Overall Survival|"Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.~Overall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals."|Time from first infusion to death, up to 2 years|TS|||Months||95% Confidence Interval|Median
2729300|NCT01023958|Secondary|Progression-free Survival|"Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.~Patients without evidence of disease progression were to be censored at the last image date."|Time from first treatment to the occurrence of tumor progression or death, up to 2 years|TS|||Weeks||95% Confidence Interval|Median
2729301|NCT01023958|Primary|Objective Tumour Response According to RECIST Criteria|Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.|From first drug administration until end of study, up to 2 years|TS|||Percentage of participants||95% Confidence Interval|Number
2729302|NCT01023841|Primary|Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score|The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2729303|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.|||Intensity units||Standard Deviation|Mean
2729304|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.|||mm^2||Standard Deviation|Mean
2729305|NCT01023841|Secondary|Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent-to-treat population included all randomized participants.|||mm||Standard Deviation|Mean
2729306|NCT01023841|Primary|Percentage of Participants With Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|5 Months|Safety population included all randomized participants who received treatment.|||Percentage of participants|||Number
2729307|NCT01023815|Secondary|Change in Serum Creatinine|Serum creatinine (a blood measurement) is an important indicator of renal health because it is an easily-measured by-product of muscle metabolism. Measuring serum creatinine is a simple test and it is the most commonly used indicator of renal function.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||mg/dL||Standard Deviation|Mean
2729308|NCT01023815|Secondary|Change in Estimated Creatine Clearance|At each visit, estimated creatinine clearance was measured in the local laboratory to analyze the evolution of the renal function. The following indirect measures of renal function were computed: estimated creatinine clearance according to Cockcroft and Gault formula and MDRD formula.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||mL/min||Standard Deviation|Mean
2729309|NCT01023815|Secondary|Number of Participants With Graft and Patient Survival After Randomization|"Graft Survival, calculated from the date of transplantation to the date of irreversible graft failure signified by return to long‐term retransplantation or the date of the last follow‐up during the period when the transplant was still functioning or to the date of death.~Patient survival, calculated from the date of transplantation to the date of death or the date of the last follow‐up."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||Participants|||Number
2729310|NCT01023815|Secondary|Biopsy Proven Acute Rejection (BPAR) Rate Between Randomization and Month 12|"Occurrence of BPAR (after randomization) between arm B (steroid withdrawal group) and arm c (standard twice-a-day group).~BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III according to Banff 1997 grading with 2007 update."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||Participants|||Number
2729311|NCT01023815|Secondary|Changes in the Estimated Glomerular Filtration Rate (eGFR) Between Randomization (Month 3) and Month 12|eGFR by Nankivell, in terms of descriptive statistics and change vs randomization visit - to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non-inferiority|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||mL/min||Standard Deviation|Mean
2733384|NCT00996333|Primary|To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks|||||||
2729312|NCT01023815|Primary|Treatment Failure Rate|Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff '97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9).|Between randomization (Month 3) and Month 12|ITT population: all randomized pts who received at least one dose of study drug after Visit 5 & have at least one post-baseline assessment of the primary efficacy variable. Change in study design stopped the randomization into Group A, due to overall slow enrollment rate & shifted all relative objectives to exploratory, due to small sample size.|||Participants|||Number
2729313|NCT01023789|Secondary|Calculated Diameter Stenosis|The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||Percent Diameter stenosis||Standard Deviation|Mean
2729314|NCT01023789|Secondary|Calculated Minimum Lumen Diameter|The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.|18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm||Standard Deviation|Mean
2729315|NCT01023789|Secondary|Mean Reference Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729316|NCT01023789|Secondary|Maximum Plaque Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729317|NCT01023789|Secondary|Minimum Plaque Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729318|NCT01023789|Secondary|Mean Plaque Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729319|NCT01023789|Secondary|Maximum Lumen Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729320|NCT01023789|Secondary|Mean Lumen Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729321|NCT01023789|Secondary|Maximum Vessel Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729322|NCT01023789|Secondary|Minimum Vessel Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729323|NCT01023789|Secondary|Mean Vessel Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729324|NCT01023789|Secondary|Minimum Lumen Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
2729325|NCT01023789|Secondary|Area Stenosis (%)||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||Percentage||Standard Deviation|Mean
2729459|NCT01023074|Secondary|SCAN-A: Competing Words Test|The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.|Test administered during one session||||units on a scale||Standard Deviation|Mean
2729326|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 3 years|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729327|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 2 years|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729328|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis (Very Late)|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|366 days to 2 years|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729329|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 1 year|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729330|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis (Late)|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|31 - 365 days|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729331|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 180 days|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729344|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||percentage of participants|||Number
2755437|NCT00839241|Secondary|Erythrocyte Volume Fraction||Baseline||||percentage of blood volume||Standard Deviation|Mean
2729332|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis (Early)|"According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including primary as well as secondary late stent thrombosis; secondary late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 30 days|ITT population (Per Subject Analysis)|||Participants|||Count of Participants
2729333|NCT01023789|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729334|NCT01023789|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 2 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729335|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729336|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 2 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729337|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729338|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729339|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729340|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|≤ 7 days post index procedure (In hospital)|ITT population (per subject analysis).|||Participants|||Count of Participants
2729341|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729342|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729343|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729402|NCT01023516|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||inhalations||Standard Error|Least Squares Mean
2729345|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729346|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729347|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729348|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729349|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729350|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729351|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729352|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729353|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729354|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729355|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729356|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729415|NCT01023516|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729357|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729358|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729359|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729360|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729361|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729362|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729363|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729364|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729365|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729366|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
2729367|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
2729368|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
2729369|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
2729370|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
2729371|NCT01023789|Secondary|Clinical Procedure Success|Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.|On day 0 (immediate post-index procedure)|ITT population (Per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||percentage of participants|||Number
2729372|NCT01023789|Secondary|Clinical Device Success|Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.|On day 0 (immediate post-index procedure)|ITT population (Per Lesion analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||percentage of lesions|Target Lesions||Number
2729373|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
2729374|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729375|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
2729376|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),~Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI)."|≤ 7 days post index procedure (In hospital)|ITT population (per subject analysis).|||Participants|||Count of Participants
2729377|NCT01023776|Secondary|Mean Difference Between Cycle Time and Detection Threshold|The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.|day 10 post vaccine 1|per protocol|||cycles||95% Confidence Interval|Mean
2729378|NCT01023776|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|28 days post vaccine 1 and 28 days vaccine 2|per protocol|||participants|||Number
2729379|NCT01023724|Primary|Anterior Chamber Inflammation (Flare)|Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.|Day 14 of treatment||||photon count per msec (pc/ms)||Standard Deviation|Mean
2729380|NCT01023711|Secondary|Assessment of the Reactogenicity Events Post Vaccination.|Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination|7 days|Subjects who completed the 7 day diary card|||participants|||Number
2729381|NCT01023711|Primary|Determination of Immune Response to Vaccination.|Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination|28 days|All subjects who completed Day 28 visit post vaccination were analyzed.|||participants|||Number
2729382|NCT01023672|Primary|Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|"The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day.~The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.~In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal."|baseline, 12 weeks|Per Protocol; 3 subjects did not complete the study (2 had worsening disease, and 1 died) and did not complete this test.|||minutes||Inter-Quartile Range|Median
2729383|NCT01023659|Primary|Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician|Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed|End of Treatment|total number of eligible participants in study|||Participants|||Count of Participants
2729384|NCT01023659|Primary|7-day Point Prevalence of Abstinence|"7-day point prevalence of abstinence was assessed by the question Have you had a cigarette, even a puff, in the past 7 days?"|6-month|Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)|||Participants|||Count of Participants
2729385|NCT01023620|Secondary|Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg||16 weeks|Investigator left the university mid way through the study and unable to find him.||||||
2729386|NCT01023620|Primary|Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg|No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed|16 weeks|No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed||||||
2729416|NCT01023516|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729387|NCT01023581|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. Includes only data collected on or after baseline and within 1 day after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.|||mg/dL||Standard Error|Least Squares Mean
2729388|NCT01023581|Secondary|Change From Baseline in HbA1c Over Time|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.~Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate."|Baseline and Weeks 4, 8, 12, 16, and 20.|The full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. The analysis includes only data collected on or after baseline and within 7 days after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2729389|NCT01023581|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26.|Full analysis set (patients who took at least 1 dose of study medication) where baseline and at least 1 postbaseline assessment were available. Analysis includes only data collected on or after baseline and within 7 days after last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2729390|NCT01023568|Secondary|Number of Participants Who Experienced Desaturation|Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after|measured at 1 minute interval at induction time and from intubation for 10 minutes.||||participants|||Number
2729391|NCT01023568|Secondary|Mean Hemodynamic Response: Heart Rate||measured at 1 minute interval at induction time and from intubation for 10 minutes.||||beats/min||Standard Deviation|Mean
2729392|NCT01023568|Secondary|Cormack-Lehane Grade||immediately after intubation||||participants|||Number
2729393|NCT01023568|Secondary|Mean Hemodynamic Response: Mean Arterial Blood Pressure||measured at 1 minute interval at induction time and from intubation for 10 minutes||||mmHg||Standard Deviation|Mean
2729394|NCT01023568|Primary|Time to Successfully Intubate Patient.||from start of intubation to successfully intubated up to 5 minutes||||seconds||Inter-Quartile Range|Median
2729395|NCT01023516|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation.|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Participants|||Number
2729396|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
2729397|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Deviation|Mean
2729398|NCT01023516|Secondary|Endurance Shuttle Walk Test - End Value|Assessed at vist 6 -( last on treatment clinic visit)|Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Error|Least Squares Mean
2729399|NCT01023516|Secondary|Endurance Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Deviation|Mean
2729400|NCT01023516|Secondary|Incremental Shuttle Walk Test - End Value||Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Error|Least Squares Mean
2729401|NCT01023516|Secondary|Incremental Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Deviation|Mean
2729460|NCT01023074|Secondary|Neural Magnetic Resonance Imaging (MRI)|Gray matter volume|Results were recorded during one scanning session|Data reported for 47 study participants who underwent MRI|||cubic cm||Standard Deviation|Mean
2729403|NCT01023516|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status). End of treatment week 12|End of treatment week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
2729404|NCT01023516|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Deviation|Mean
2729405|NCT01023516|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
2729406|NCT01023516|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Deviation|Mean
2729407|NCT01023516|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
2729408|NCT01023516|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Deviation|Mean
2729409|NCT01023516|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729410|NCT01023516|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729411|NCT01023516|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak expiratory flow (PEF)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2729412|NCT01023516|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Deviation|Mean
2729413|NCT01023516|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729414|NCT01023516|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729417|NCT01023516|Secondary|End-value Post-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Error|Least Squares Mean
2729418|NCT01023516|Secondary|Baseline Post-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Deviation|Mean
2729419|NCT01023516|Secondary|End-value Pre-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Error|Least Squares Mean
2729420|NCT01023516|Secondary|Baseline Pre-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Deviation|Mean
2729421|NCT01023516|Secondary|End-value Post-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729422|NCT01023516|Secondary|Baseline Post-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729423|NCT01023516|Secondary|End-value Pre-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729424|NCT01023516|Secondary|Baseline Pre-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729425|NCT01023516|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729426|NCT01023516|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729427|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729428|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729429|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729430|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729431|NCT01023516|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2729432|NCT01023516|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2729433|NCT01023308|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group|Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.|12, 24 and 48 weeks|Full Analysis Set|||score on a scale||95% Confidence Interval|Least Squares Mean
2729434|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group|"The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set|||score on a scale||95% Confidence Interval|Least Squares Mean
2729435|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group|"Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set|||score on a scale||95% Confidence Interval|Least Squares Mean
2729436|NCT01023308|Secondary|Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||months||95% Confidence Interval|Median
2729437|NCT01023308|Secondary|Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||duration of response in months||95% Confidence Interval|Median
2729438|NCT01023308|Secondary|Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||time to response in months||95% Confidence Interval|Median
2729439|NCT01023308|Secondary|Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.|Best overall response based on mEBMT criteria per investigator assessment|45 months||||% participants with response|||Number
2729440|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|survival time in months|45 months|FAS|||months||95% Confidence Interval|Median
2729441|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|Number of OS events|45 months||||Number of OS events|||Number
2729442|NCT01023308|Primary|Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|Full Analysis Set|||months||95% Confidence Interval|Median
2729443|NCT01023308|Primary|Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||number of events|||Number
2729461|NCT01023074|Primary|Electrophysiological Auditory Test|"auditory P300 amplitude in response to rare 1000 Hz tones"|Recordings were conducted during one session||||microvolts||Standard Deviation|Mean
2729444|NCT01023269|Primary|Functional Bladder Capacity|Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.|Baseline, 4 weeks after implant, 8 weeks after implant|Due the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.|||ml||Standard Deviation|Mean
2729445|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 8|At week 8, MRI data were not available for 6 placebo patients, 5 MOR103 0.3 mg/kg patients, 1 MOR103 1.0 mg/kg patient, and 2 MOR103 1.5 mg/kg patients.|||units on a scale||Standard Deviation|Mean
2729446|NCT01023256|Secondary|Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8|Patient-reported outcomes included patient's self-assessment of pain (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).|Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8|All treated patients|||units on a scale||Standard Deviation|Mean
2729447|NCT01023256|Secondary|Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8|Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.|Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8|All treated patients|||joints||Standard Deviation|Mean
2729448|NCT01023256|Secondary|Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4|The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.|Week 4 (1 week after last MOR103 dose)|All participants were included in ACR response calculations. Patients lacking data required for calculation of an ACR response were considered as not having an ACR response. 1 patient in the MOR103 0.3 mg/kg group, 1 patient in the MOR103 1.0 mg/kg group, and 5 patients in the pooled placebo group had missing data for ACR calculations.|||percentage of participants|||Number
2729449|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)|Change from baseline to week 8 (5 weeks after last MOR103 dose)|All treated patients|||units on a scale||Standard Deviation|Mean
2729450|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 4 (1 week after last MOR103 dose)|At week 4, MRI data were not available for 5 placebo patients, 2 MOR103 0.3 mg/kg patients, 2 MOR103 1.0 mg/kg patients, and 1 MOR103 1.5 mg/kg patient.|||units on a scale||Standard Deviation|Mean
2729451|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).|Change from baseline to week 4 (1 week after last MOR103 dose)|All treated patients|||units on a scale||Standard Deviation|Mean
2729452|NCT01023256|Primary|Percentages of Patients With Treatment-emergent or Serious Adverse Events|Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of >5 % (>1 patient) in any treatment group, please see the adverse events listing.|From the first dose through the 16-week visit|All patients who received treatment.|||percentage of participants|||Number
2729453|NCT01023217|Secondary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 104 from randomization|||||||
2729454|NCT01023217|Secondary|Normalization of ALT Level||at week 52 and at week 104 from randomization|||||||
2729455|NCT01023217|Secondary|Genotypic Resistance to ADV or ETV||at week 52 and at week 104 from randomization|||||||
2729456|NCT01023217|Secondary|Reduction in Serum HBV DNA Levels||at week 52 and at week 104 from randomization|||||||
2729457|NCT01023217|Primary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 52 from randomization||||participants|||Number
2729458|NCT01023178|Primary|Estradiol|Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.|end of study (up to 2 years)||||pg/mL||Standard Error|Mean
2755438|NCT00839241|Secondary|Hemoglobin||Day 8 postop||||g/dL||Standard Deviation|Mean
2729462|NCT01023061|Secondary|Median Time to Prostate Specific Antigen Progression|Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals.|6 months|Treated patients|||years||Standard Deviation|Mean
2729463|NCT01023061|Primary|Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry|The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care.|Week 12|Treated patients with measurable tissue DHT|||pg/mg||90% Confidence Interval|Median
2729464|NCT01023061|Primary|Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.|Up to 24 months after initiation of radiation therapy|Treated patients|||Participants|||Count of Participants
2729465|NCT01023035|Secondary|Percentage of Participants Who Discontinued Treatment|Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification [LLQ] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).|From Study Day 1 up to Study Treatment Week 48|All Treated Participants, defined as all participants who were treated with any study medication.|||percentage of participants||95% Confidence Interval|Number
2729466|NCT01023035|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24|At Follow-up Week 24|The primary efficacy analysis was performed on all participants who were randomized to either the RBV Dose Reduction Arm or the EPO Use Arm for anemia management (i.e. the Full Analysis Set of patients requiring anemia management [FAS, n=500]).|||percentage of participants|||Number
2729467|NCT01023022|Secondary|Handling of Unscheduled Activities (for Example, Symptoms and Events)|"Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other"|Baseline to max. 12 months|The 68 patients of total population (176) were analyzed as this number of pt. had experienced unscheduled visit during the study.|||% of unscheduled visits due to reasons|unscheduled visits||Number
2729468|NCT01023022|Secondary|Efficiency Through Increased Flexibility and Per Procedure Time||Baseline to max. 12 months|||||||
2729469|NCT01023022|Secondary|Time and Costs Savings for Physicians||Baseline to max. 12 months|||||||
2729470|NCT01023022|Secondary|Time and Cost Savings for Patients||Baseline to max. 12 months|||||||
2729471|NCT01023022|Secondary|Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)||Baseline to max. 12 months|||||||
2729472|NCT01023022|Secondary|Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)||Baseline to max. 12 months|||||||
2729473|NCT01023022|Secondary|Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)|"Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data"|Baseline to max. 12 months|Number of patients who provided responses for these questions at the end of the Study.|||percentage of patients|||Number
2729474|NCT01023022|Primary|Comparison of Remote Device Check and In-clinic Device Assessment|"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"|Baseline to max. 12 months|Number of Investigators who provided responded for these questions at the end of evaluation.|||percentage of Investigators|||Number
2729475|NCT01022996|Secondary|Progression Free Survival (PFS) by Kaplan-Meier Estimate|Progression-free survival (PFS) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||95% Confidence Interval|Median
2729487|NCT01022853|Secondary|Tmax of Nintedanib|"Time from dosing to the maximum measured concentration, Cmax, of Nintedanib (tmax) in Cycle 1.~400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient."|5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9|PK analysis set.|||h||Full Range|Median
2729476|NCT01022996|Secondary|Duration of Disease Control|The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||Standard Deviation|Mean
2729477|NCT01022996|Secondary|Disease Control Rate (DCR)|The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Percentage of participants||95% Confidence Interval|Number
2729478|NCT01022996|Secondary|Duration of Overall Response (DoR)|The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||Standard Deviation|Mean
2729479|NCT01022996|Secondary|Time to Overall Response (TTR) Per Kaplan-Meier Estimate|Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||95% Confidence Interval|Median
2729480|NCT01022996|Primary|Overall Response Rate (ORR) Based on the Assessments by Investigator|ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal & extranodal lesions: Radiological regression to normal size of all lymph nodes & nodal masses & complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal & extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal & extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented & one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.|at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||percentage of participants|||Number
2729481|NCT01022853|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from start of treatment with study medication to tumour progression or death whichever occurs first. Tumour response was to be documented using appropriate techniques such as magnetic resonance imaging (MRI) or computer tomography (CT).|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||days||Full Range|Median
2729482|NCT01022853|Secondary|Duration of Disease Control|Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|All patients of the treated set that were assessed to show disease control.|||days||Full Range|Median
2729483|NCT01022853|Secondary|Number of Patients With Disease Control|Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Disease control is defined as complete response (CR), partial response (PR) or stable disease (SD) as best response throughout the study.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||participants|||Number
2729484|NCT01022853|Primary|Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib|The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development.|28 days|Treated Set. All patients who received >= 1 dose of study medication.|||mg|||Number
2729485|NCT01022853|Secondary|Number of Patients With Objective Response (OR)|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR) as best response throughout the study.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||participants|||Number
2729486|NCT01022853|Secondary|Number of Patients With Best Overall Response|Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as the best overall response (complete response, partial response, stable disease, progressive disease or not evaluable) since the start of treatment.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||participants|||Number
2729505|NCT01022762|Secondary|Change in Fasting Plasma Glucose||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
2729488|NCT01022853|Secondary|AUC(0-6h) of Nintedanib|"Area under the concentration-time curve (AUC) of Nintedanib over the time interval 0 to 6 hours in Cycle 1.~400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient."|5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9|PK analysis set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2729489|NCT01022853|Secondary|Cmax of Nintedanib|"Maximum measured concentration (Cmax) of Nintedanib in Cycle 1.~400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient."|5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9|PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729490|NCT01022853|Secondary|Vss of Volasertib|Volume of distribution at steady state (Vss) of Volasertib in Cycle 1.|0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion|PK analysis set.|||L||Geometric Coefficient of Variation|Geometric Mean
2729491|NCT01022853|Secondary|CL of Volasertib|Total plasma Clearance (CL) of Volasertib in Cycle 1.|0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion|PK analysis set.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2729492|NCT01022853|Secondary|Cmax of Volasertib|Maximum measured concentration (Cmax) in plasma of Volasertib in Cycle 1.|0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion|Pharmacokinetic (PK) analysis set. The PK analysis set included all patients who took at least 1 dose of study medication and provided at least 1 blood sample following drug administration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729493|NCT01022853|Secondary|Number of Participants With Dose Limiting Toxicities|"Number of participants with dose limiting toxicities (DLTs).~DLT was defined as:~Drug-related CTCAE grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or~Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or~CTCAE grade 4 thrombocytopenia"|From first study drug administration until 28 days after the last administration of any study medication, up to 485 days|Treated Set.|||participants|||Number
2729494|NCT01022853|Secondary|Number of Participants With Drug Related Adverse Events|Number of participants with investigator-defined drug related adverse events.|From first study drug administration until 28 days after the last administration of any study medication, up to 485 days|Treated Set.|||participants|||Number
2729495|NCT01022853|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).|"DLT was defined as:~Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or~Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or~CTCAE grade 4 thrombocytopenia"|28 days|Treated set. All patients who received ≥1 dose of study medication were included in the treated set.|||participants|||Number
2729496|NCT01022762|Secondary|Change in Body Weight||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation|||kg||Standard Error|Least Squares Mean
2729497|NCT01022762|Secondary|Cholesterol|"The number of participants having a change in cholesterol from normal to abnormal. Abnormal means a value of blood cholesterol is out of the normal range."|Week 0, week 16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s)|||participants|||Number
2729498|NCT01022762|Secondary|Number of All Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.|Weeks 0-16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s). One participant was randomised into repaglinide group, but was dispensed gliclazide from the very beginning of the study due to the investigator's negligence. This participant continued the gliclazide treatment until the end of the study.|||episodes|||Number
2729499|NCT01022762|Secondary|Change in AUC0-180 of Plasma Glucose Concentration of IVGTT||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.|||min*mmol/L||Standard Deviation|Mean
2729500|NCT01022762|Secondary|Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.|||min*pmol/L||Standard Deviation|Mean
2729501|NCT01022762|Secondary|Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
2729502|NCT01022762|Secondary|Change in Fasting Serum Free Fatty Acid (FFA) From Baseline||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
2729503|NCT01022762|Secondary|Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%||Week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||percentage of participants|||Number
2729504|NCT01022762|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal|A standard meal contains 100g carbohydrate|Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
2740728|NCT00946088|Secondary|Maternal Anticipated Adverse Medication Reaction||Up to the maternal discharge from delivery hospitalization||||Participants|||Count of Participants
2729506|NCT01022762|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
2729507|NCT01022567|Secondary|The Recurrence of Conservatively Treated Appendicitis||up to 10 years||2022-06-30|06/2022||||
2729508|NCT01022567|Secondary|The Direct and Indirect Costs of Both Treatment Arms||1 year|||||||
2729509|NCT01022567|Secondary|The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment||1 year|||||||
2729510|NCT01022567|Primary|The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis|A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.|Up to 10 years|Treatment success|||percentage of successful treatment||95% Confidence Interval|Number
2729511|NCT01022502|Secondary|Patients Preferred Ointment Type.|At the end of the trial, the patients were asked which ointment they preferred.|Week 8|Total number of participants completing the 8 week period with study intervention.|||participants|||Number
2729512|NCT01022502|Secondary|Patients' Rating of the Overall Improvement at Week 8|At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention and who reported excellent or cleared at week 8 were used for analysis.|||participants|||Number
2729513|NCT01022502|Primary|Percentage Improvement Compared to Baseline in the Target Plaque.|The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared percent of improvement related to baseline between the two lesions and before treatment with those after treatment.|||percent change of target plaque||95% Confidence Interval|Mean
2729514|NCT01022502|Primary|Clearing Percentage of Target Plaque Area|The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared clearing percent of target plaque between the two lesions and before treatment with those after treatment.|||percentage of the target area||95% Confidence Interval|Mean
2729515|NCT01022502|Primary|Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.|The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared PSI scores between the two lesions and before treatment with those after treatment.|||units on a scale||95% Confidence Interval|Mean
2729516|NCT01022424|Primary|Renal Function Test (eGFR)|"Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period.~Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded."|Baseline, Week 48, 96, 144, and 192||||mL/min/1.73 m2||Inter-Quartile Range|Median
2729517|NCT01022424|Primary|Total Kidney Volume|"Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.~Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.~Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded."|Baseline, Week 48, 96, 144, and 192||||mL||Inter-Quartile Range|Median
2729518|NCT01022398|Primary|Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy||6 months|||||||
2729519|NCT01022307|Primary|Performance on Trail-making Test, Part B|z-score based on response time, regressed for age and computer use|Single session generally several years after TBI depending on time of recruitment of subjects.|z-score|||z-score||Standard Deviation|Mean
2729520|NCT01022242|Primary|TAM2|The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.|At 12 weeks after surgery|FAS population|||Degrees||Full Range|Median
2729521|NCT01022203|Secondary|Emotion Regulation|Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.|||units on a scale||Standard Deviation|Mean
2729522|NCT01022203|Secondary|Relationship Functioning|Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.|||units on a scale||Standard Deviation|Mean
2740729|NCT00946088|Secondary|Maternal Chorioamnionitis||Up to maternal hospital discharge||||Participants|||Count of Participants
2729523|NCT01022203|Primary|Psychological Functioning|Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.|||units on a scale||Standard Deviation|Mean
2729524|NCT01022190|Primary|Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively.|"Percentage of participants in which Heterotopic Ossification of the hip was assessed, according to the Brooker grade.~Brooker-0): No ossification. Brooker-1): Isolated bone islands, Brooker-2): Bone spurs from the pelvis or proximal femur;space between opposing surface ≥ 1 cm, Brooker-3): Bone spurs from the pelvis or proximal femur;space between opposing surface < 1 cm, Brooker-4): Apparent bony ankylosis. Brooker score 1 to 4 are considered 'heterotopic ossification'."|6 months postoperatively|Patients who underwent total hip arthroplasty and received afterwards Etoricoxib medication.|||percentage of participants|||Number
2729525|NCT01022112|Secondary|Safety and Tolerability||14 weeks|||||||
2729526|NCT01022112|Secondary|Fasting Blood Glucose, Body Weight||12 weeks|||||||
2729527|NCT01022112|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||12 weeks|Full analysis set, last observation carried forward|||percent HbA1C||Standard Error|Least Squares Mean
2729528|NCT01022073|Primary|Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher the value, the worse the outcome.|The change score of UPDRS Part III from baseline to 9 years post surgery|Patients had completed the 9 year follow-up post surgery|||units on a scale||Standard Deviation|Mean
2729529|NCT01021956|Post-Hoc|Number of Participants With Any Ocular or Non-ocular Adverse Events|Global safety assessment including record of all complications and AEs, loss of lines in BCVA, slit lamp findings, IOP(Intra Occular Pressure), and fundus findings. All ocular and non-ocular AEs must be assessed for severity and relationship to the investigational product. Of note: the primary end point only concern patient with eye disorders events.|Day 1;Week 1;Week 5;Week 12.||||participants|||Number
2729530|NCT01021956|Secondary|Visual Acuity|"Variation from baseline to week 12 in visual acuity score using Early Treatment Diabetic Retinopathy Study (ETDRS) 4.0 meter distance acuity chart.~The patient is asked to read letter on a board from a distance of 4 meters. The charts use a geometric progression in letter size from line to line. The scores range from 0 (worse outcome) to 100/100 (best outcome)"|Week 12.|Although STAKEL® VTP procedure induced effective neovessels occlusion in some patients, as observed in the previous study (study MLT 2.01 ), due to the small number of patients treated and the early termination of the study, limited efficacy data is available and no efficacy conclusion can be drown from this study.|||score on a scale||Full Range|Median
2729531|NCT01021956|Primary|Adverse Events (AEs) - Number of Subjects With Eye Disorders|Adverse events (AEs) consisting in Eye disorders, related or non related were collected throughout the study.|12 week follow-up|The safety analysis set included all subjects with a signed informed consent form who received study treatment|||participants|||Number
2729532|NCT01021878|Secondary|Total Ultrafiltration|Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.|3 months||||millilitre||95% Confidence Interval|Mean
2729533|NCT01021878|Secondary|Glycated Hemoglobin|"Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.~Glycated hemoglobin was measured by high-performance liquid chromatography."|3 months||||percentage of haemoglobin||95% Confidence Interval|Mean
2729534|NCT01021878|Secondary|Serum Insulin|Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.|3 months||||log(mmol/L)||95% Confidence Interval|Mean
2729535|NCT01021878|Secondary|Oral Fasting Serum Glucose|"Serum glucose measured in oral fasting but not peritoneal fasting.~For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05."|3 months||||mg/dl||95% Confidence Interval|Mean
2729536|NCT01021878|Primary|Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor|"Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:~(fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405"|3 months||||IR score||95% Confidence Interval|Mean
2729551|NCT01021813|Primary|Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase|Falls were adjudicated (to establish whether a fall event was due to cataplexy).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2729552|NCT01021813|Primary|Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase|Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2729537|NCT01021852|Primary|Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.|||percentage of participants|||Number
2729538|NCT01021852|Primary|Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.|||percentage of participants|||Number
2729539|NCT01021852|Secondary|Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment|LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R&K scoring. LS mean LPS was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization LPS efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
2729540|NCT01021852|Secondary|Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment|WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization WASO efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
2729541|NCT01021852|Primary|Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment|SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||percentage of time in bed spent sleeping||Standard Error|Least Squares Mean
2729542|NCT01021813|Other Pre-specified|Number of Participants Who Reported Suicidal Ideation and/or Behavior On Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidal ideation and/or behavior that occurred on study was also assessed using the C-SSRS, a rater-administered questionnaire used to prospectively assess suicidal ideation and suicidal behavior. C-SSRS assessment was based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale.~Suicidal ideation and/or behaviors identified on the C-SSRS may not have been considered an adverse event, based on the investigator's judgment."|From the first day of study treatment through study follow-up (up to 14 months)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||participants|||Number
2729543|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase|The sTSOm was defined as the average over time of daily e-diary values for a participant's report of the time he or she required to fall asleep (measured in minutes). Weekly sTSOm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSOm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.|||minutes||95% Confidence Interval|Least Squares Mean
2729544|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase|The sTSTm was defined as the average over time of daily e-diary values for a participant's report of the total amount of time spent asleep before waking for the day (measured in minutes). Weekly sTSTm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSTm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.|||minutes||95% Confidence Interval|Least Squares Mean
2729545|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective time to sleep onset (sTSO) as recorded in the participant's morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTSO value (in minutes) on any of the first 3 nights of the Run-out Phase occurring after one year of treatment (Month 13) was greater than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.|||percentage of participants|||Number
2729546|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective total sleep time (sTST) as recorded in the participant's morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTST value (in minutes) on any of the 3 nights of the Run-out Phase (first 3 nights of the Discontinuation Phase) occurring after one year of treatment (Month 13) was less than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.|||percentage of participants|||Number
2729547|NCT01021813|Secondary|Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ)|"Withdrawal effects assessed using Tyrer WSQ, which evaluated the presence/absence and severity of withdrawal symptoms with 20 items (i.e. sensitivity to noise, light, smell, touch, feeling unreal, etc). The Tyrer WSQ was completed as part of the evening e-diary prior to dosing on the Month 12 visit and on the 3 consecutive evenings of the DB Run-out Phase (first 3 nights of DB Discontinuation Phase). Responses rated 0 (No), 1 (Yes-moderate), or 2 (Yes-severe); range from 0 (no withdrawal) to 40 (severe withdrawal).~A participant was defined to have a withdrawal symptom if an item during any of the 3 DB Run-out days had emerged for the first time, or had worsened compared to the measurement obtained at the end of the Treatment phase (Month 12). For single night analysis, a patient was defined to have withdrawal effects if the number of withdrawal symptoms (emergent or worsening) was ≥3. For across night analysis, withdrawal was defined as a total of ≥3 symptoms across the 3 nights."|Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out])|Participants in the APaT population who completed the entire DB Treatment Phase, had at least one measurement at the end of the DB Treatment Phase (Month 12), had taken at least one dose of Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.|||percentage of participants|||Number
2729548|NCT01021813|Primary|Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase|The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2729549|NCT01021813|Primary|Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase|Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2729550|NCT01021813|Primary|Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase|Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2735895|NCT00977574|Secondary|Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.||Median of 10 cycles of treatment plus 30 days|Treated patients|||Participants|||Count of Participants
2729553|NCT01021813|Primary|Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase|Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment|||percentage of participants|||Number
2729554|NCT01021813|Primary|Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase|Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
2729555|NCT01021761|Primary|Aqueous PGE2 Inhibition|A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.|Day 4 of treatment|Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.|||pg/ml||Standard Deviation|Mean
2729556|NCT01021748|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which was temporally associated with the use of study drug was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 20 months|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2729557|NCT01021748|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which was temporally associated with the use of study drug was also an AE. The number of participants who experienced at least one AE is presented.|Up to approximately 23 months|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2729558|NCT01021748|Secondary|Number of Participants With a Tumor Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Radiological evaluation (via computed tomography [CT] or magnetic resonance imaging [MRI]) of tumor response was assessed every 8 weeks post-treatment during Cycles 1-6, and per institutional standard of care in Cycle 7 and beyond. The best overall tumor response was the best response based on RECIST 1.1 recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants whose tumor was not evaluable (NE) were missing a valid RECIST1.1 measurement at baseline. The best overall tumor response for participants is presented.|Baseline and after every 8 weeks of treatment until documentation of objective response or disease progression (Up to 2 years)|The analysis population consisted of all participants with assessable disease at baseline or measureable disease at baseline per RECIST1.1.|||Participants|||Number
2729559|NCT01021748|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|Adverse events (AEs) were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. DLTs included: Grade 4 neutropenia lasting for ≥7 days; Grade 3 or Grade 4 neutropenia with fever >38.5ºC and/or infection requiring antibiotic or anti-fungal treatment; Grade 4 thrombocytopenia (≤25.0 x 10^9/L); Grade ≥3 non-hematologic toxicity with exceptions; Any drug-related AE, regardless of CTCAE Grade, leading to a dose modification of MK-2206 or AZD6244; Unresolved CTCAE Grade ≥3 drug-related toxicity requiring drug interruption for >14 days; ≥ Grade 3 signs or symptoms of glucose intolerance and accompanied by ≥ Grade 2 hyperglycemia (glucose >160 dL or 8.9 mmol/L); ≥ Grade 3 electrolyte abnormalities due to glucose intolerance and not attributable to another cause; Diagnosis of lactoacidosis or ketoacidosis; Persistent increases in corrected QT (QTc) interval (>60 msec from baseline and/or >500 msec); Clinically significant bradycardia.|Cycle 1 (Up to 28 days)|The population consisted of all participants who completed ≥ 80% of the first cycle of combination therapy unless interruption of study medication was due to toxicity (e.g. DLT).|||Participants|||Number
2729560|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Breakthrough Fungal Infection|Plasma level of itraconazole was defined as the sum of IC and HIC. A breakthrough fungal infection was defined as any fungal infection that was diagnosed more than (>) 3 days on or during therapy or within 7 days after completion of therapy. Blood cultures were assessed to identify fungus.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.|||ng/mL||Standard Deviation|Mean
2729561|NCT01021683|Secondary|Percentage of Participants With Baseline Fungal Infection|Blood cultures (a laboratory test on a sample of blood) were assessed to identify fungus. Percentage of participants with presence or absence of fungus before starting the study drug were calculated.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Percentage of Participants|||Number
2729573|NCT01021553|Secondary|Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone)|Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2731938|NCT01004393|Secondary|Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
2729562|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment|Plasma level of itraconazole was defined as the sum of IC and HIC. The OSR was defined based on satisfaction of the following criteria: (1) participants if treated for baseline fungal infection, there was either eradication (removal of fungus in culture), or presumed eradication; no evidence in culture but appeared to be treated clinically, (2) absence of breakthrough fungal infection during the treatment and for 7 days after completing the treatment, (3) survival for 7 days after completing the treatment, (4) absence of early withdrawal due to adverse events or lack of efficacy, and (5) defervescence. The presence and absence of OS was reported.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.|||ng/mL||Standard Deviation|Mean
2729563|NCT01021683|Secondary|Percentage of Participants With Defervescence by Plasma Level of Itraconazole|Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment. Plasma level of itraconazole was defined as the sum of IC and HIC.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'n' signifies participants who were evaluable for this measure at given time points.|||Percentage of Participants|||Number
2729564|NCT01021683|Secondary|Absolute Neutrophil Count (ANC)|The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Cells/mm^3||Standard Deviation|Mean
2729565|NCT01021683|Secondary|Duration of Neutropenia|The duration of neutropenia was reported. Neutropenia was defined as neutrophil count less than or equal to (<=) 500 cells per cubic millimeter (cells/mm^3), or neutrophil count <=1000 cells/mm^3 and anticipated to decrease to <=500 cells/mm^3 within several days.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Days||Standard Deviation|Mean
2729566|NCT01021683|Secondary|Mean Time to Defervescence in Participants Who Received the Study Treatment|The mean time to defervescence was reported in participants who received the study treatment. Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
2729567|NCT01021683|Secondary|Percentage of Participants With Deferevescence After Administration of Study Treatment|Defervescence was defined as fall of the body temperature below 38.0 degree Celsius (C) at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Percentage of Participants|||Number
2729568|NCT01021683|Primary|Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment|Percentage of participants who achieved more than or equal to 1000 ng/ml level after administration of study treatment were reported. Plasma level of itraconazole was defined as the sum of itraconazole concentration (IC) and hydroxyitraconazole concentration (HIC).|Day 5|The intent-to-treat (ITT) population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Percentage of Participants||95% Confidence Interval|Number
2729569|NCT01021618|Secondary|Myocardial Perfusion Image Quality|Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).|0 hours|Note that images were unavailable in one vasodilator-exercise patient because of urgent catheterization after stress test without imaging and one exercise-vasodilator patient for technical reasons.|||participants|||Number
2729570|NCT01021618|Primary|"Number of Participants With Major Adverse Events or Side Effects Graded Severe on Symptom Questionnaire"|"Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as severe by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis."|24 hours|Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.|||participants|||Number
2729571|NCT01021553|Secondary|Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling|The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models.|Up to Week 8|ITT Population. Data was not collected for this outcome measure.||||||
2729572|NCT01021553|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication.|Baseline and up to follow up (post treatment 48 hours)|Safety Population.|||Participants|||Number
2729574|NCT01021553|Secondary|Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry)|Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2729575|NCT01021553|Secondary|Mean Change From Baseline in Electrocardiogram (ECG) Values|ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia's formula (QTc [Fridericia]), QT duration corrected for heart rate by Bazett's formula (QTc [Bazett]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant's Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
2729576|NCT01021553|Secondary|Mean Change From Baseline in Heart Rate|Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2729577|NCT01021553|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.|Baseline and up to follow up (post treatment 48 hours)|The Safety Population consisted of all participants randomized to study treatment who received at least one dose of study drug. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2729578|NCT01021553|Secondary|Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296|The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population. Only those participants with data available at the indicated time points were analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
2729579|NCT01021553|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK557296|The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2729580|NCT01021553|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296|The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population consisted of all participants from whom a PK sample had been obtained and analyzed. Only those participants with data available at the indicated time points were analyzed.|||Hours times nanograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
2729581|NCT01021553|Secondary|Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included.|Baseline and Week 4|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||minutes||Standard Deviation|Mean
2729582|NCT01021553|Secondary|Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included.|Baseline and up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||minutes||Standard Deviation|Mean
2729583|NCT01021553|Secondary|Mean IELT Compared After the First Dose of Study Drug or Placebo|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||minutes||Standard Error|Geometric Mean
2729584|NCT01021553|Secondary|Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation|Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||minutes||Standard Error|Geometric Mean
2729585|NCT01021553|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation|Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|Intent to Treat (ITT) Population consisted of all participants randomized to study treatment. Only those participants with data available at the indicated time points were analyzed.|||minutes||Standard Error|Geometric Mean
2729586|NCT01021423|Secondary|Participants With a Tumor Response|"Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.||||||
2729587|NCT01021423|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.|up to 2 years|Study terminated prematurely. Analysis not conducted.||||||
2729588|NCT01021423|Secondary|Time to Progression|"Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.||||||
2729589|NCT01021423|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|"Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to 9 months|Safety population of participants who received at least one dose of study drug|||participants|||Number
2729590|NCT01021423|Secondary|Overall Survival|"Overall survival was defined as the time from randomization to death from any cause.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.||||||
2729591|NCT01021423|Primary|Progression-free Survival (PFS)|"PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.||||||
2729592|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729723|NCT01020123|Secondary|C-reactive Protein: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 234 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
2729593|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
2729594|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
2729595|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
2729596|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
2729597|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
2729598|NCT01021332|Secondary|Number of OAB-q Responders Based on Health-related Quality of Life: Total Score|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||percentage of participants|||Number
2729599|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729600|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729601|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729602|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2755439|NCT00839241|Secondary|Hemoglobin||Day 5 postop||||g/dL||Standard Deviation|Mean
2729603|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729604|NCT01021332|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729605|NCT01021332|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2729606|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2729607|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2729608|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2729609|NCT01021332|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2729610|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.|||pads||Standard Deviation|Mean
2729611|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.|||nocturia episodes||Standard Deviation|Mean
2729612|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.|||incontinence episodes||Standard Deviation|Mean
2729626|NCT01021293|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.|During the entire study period (from Day 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2755440|NCT00839241|Secondary|Hemoglobin||Day 1 postop||||g/dL||Standard Deviation|Mean
2729613|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.|||urgency incontinence episodes||Standard Deviation|Mean
2729614|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with at least 1 urgency episode at baseline. LOCF imputation was used.|||urgency episodes||Standard Deviation|Mean
2729615|NCT01021332|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||ml||Standard Deviation|Mean
2729616|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||ml||Standard Deviation|Mean
2729617|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||micturitions||Standard Deviation|Mean
2729618|NCT01021332|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and up to 52 weeks of FDC treatment|Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2729619|NCT01021332|Primary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline micturition episode.|||ml/s||Standard Deviation|Mean
2729620|NCT01021332|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseine and one post-baseline micturition episode.|||ml/s||Standard Deviation|Mean
2729621|NCT01021332|Primary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline PVR volume measured.|||ml||Standard Deviation|Mean
2729622|NCT01021332|Primary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).|From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)|Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period|||participants|||Number
2729623|NCT01021306|Secondary|Bothersomeness of Symptoms|Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)|2 months||||units on a scale||95% Confidence Interval|Mean
2729624|NCT01021306|Secondary|Oral Health Impact Profile (OHIP-14)|The OHIP-14 contains 2 questions about each of 7 dimensions (14 items), indicating how often the participant had experienced each difficulty in the previous month; possible responses range from 0 (never) to 4 (very often). The OHIP score was obtained by summing the 14 ratings.|2 months||||units on a scale||95% Confidence Interval|Mean
2729625|NCT01021306|Primary|Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)|The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).|2 months||||units on a scale||95% Confidence Interval|Mean
2741862|NCT00939211|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h||||mmHg||Standard Deviation|Mean
2729627|NCT01021293|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2729628|NCT01021293|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
2729629|NCT01021293|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.|During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
2729630|NCT01021293|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2729631|NCT01021293|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.|At Day 0, prior to the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2729632|NCT01021293|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).|At Month 3, one month after the third vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2729633|NCT01021215|Secondary|Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels|Proportion of cases with a post-treatment increase in urinary PGE-M levels by comparing those treated with Zileuton and Celecoxib combined therapy compared to those treated with Zileuton alone. Pre/postchange in levels (Increase) derived from baseline level to Day 6 +/- 1 day. Differences in baseline levels between 2 treatment arms were examined using the Wilcoxon rank-sum test.|Baseline to Day 6|Analysis includes only number of participants in each treatment arm with post-treatment increase in urinary PGE-M levels as measured from baseline.|||proportion of participants|||Number
2729634|NCT01021215|Primary|Median Urinary LTE4 Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary LTE4 levels measured in each treatment arm compared using paired t-test should the data conform to the normality assumption or one-sample Wilcoxon rank-sum test. LTE4 levels reported as median with full range (pg/mg creatinine) for Pre treatment versus Post treatment LTE4 levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and day 6|Seventy-seven subjects completed the entire study, three withdrew for personal reasons. Seven of those participants were excluded from analysis as non-compliant (study medications were undetectable).|||pg/mg creatinine||Full Range|Median
2729635|NCT01021215|Primary|Median Urinary PGE-M Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary PGE-M levels measured in each treatment arm. PGE-M levels reported as median with full range (ng/mg creatinine) for Pre treatment versus Post treatment PGE-M levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and Day 6|Seventy-seven subjects completed the entire study with seven of those excluded from analysis as non-compliant (study medications were undetectable). Urine of two participants contained interfering substances thus were excluded from PGE-M related analysis.|||ng/mg creatinine||Full Range|Median
2729636|NCT01021137|Secondary|Dizziness Handicap Inventory|"The Dizziness Handicap Inventory (DHI) was used as a quality of life measure.The DHI measures the subject's self-perceived dizziness. The scale has 25 questions with 3 possible answers each: Yes = 4 points, Sometimes = 2 points, and No = 0 points. The minimum number of points that a subject can score is 0 and the maximum number of points is 100. The subject's self-perceived dizziness is reported as a percentage with a range of 0-100%, and is calculated by: subject's total number of points/maximum number of points (100) x 100%. The higher the score on the DHI, the worse a patient's self-perceived dizziness."|Up to 10 minutes||||score on a scale||Standard Deviation|Mean
2755441|NCT00839241|Secondary|Hemoglobin||Baseline||||g/dL||Standard Deviation|Mean
2729637|NCT01021137|Secondary|Postural Stability: Sensory Organization Test (SOT)|This measure is the composite equilibrium score from six conditions of the sensory organization test obtained with the Neurocom Equitest. Results of the SOT were calculated based on maximum peak-to-peak anterior-posterior sway expressed as an equilibrium score ranging from 0 to 100, with 0 indicating loss of balance (i.e., required support of harness, took a step, touched walls for support or opened eyes in eyes closed conditions) and 100 indicating perfect stability. The outcome measure was the equilibrium composite score and was calculated by the software as the weighted average of the equilibrium scores for the six conditions. For ages 18-59 years, the normative value (mean - 1.67 SD) for the composite score is at least 70 (NeuroCom, 2011).|Up to 20 minutes|The composite equilibrium score of the sensory organization test was not obtained for 4 participants in the TBI & Blast group, 2 participants in the Blast Only group and 2 participants in the Healthy Control group.|||units on a scale||Standard Deviation|Mean
2729638|NCT01021137|Secondary|Central Vestibular/Central Nervous System (CNS) Function: Visual Fixation Suppression|Visual fixation suppression was used as a measure of central vestibular/CNS function. Visual fixation suppression is a measure of vestibulo-ocular reflex (VOR) gain obtained during visual fixation at 0.16 Hz slow harmonic acceleration on the rotary chair. VOR gain was defined as the ratio of the slow component velocity eye movement (output) to the velocity of the head movement (input). Visual fixation suppression was considered normal if VOR gain is suppressed > 50% with visual fixation compared to no fixation.|1 minute|VOR gain during a visual fixation task and 0.16 Hz could not be obtained on 2 participants in the TBI & Blast group and 3 participants in the Blast Only group.|||unitless||Standard Deviation|Mean
2729639|NCT01021137|Primary|Peripheral Vestibular Function (Utricular-ocular Pathway): Ocular Vestibular Evoked Potential (oVEMP)|"Bone-conducted ocular vestibular evoked potential (oVEMP) inter-ear amplitude asymmetry ratio was used as a measure of otolith organ function (utricular-ocular pathway). Inter-ear amplitude asymmetry ratio was calculated as: [(|L_N1-P1| - |R_N1-P1|)/ (|L_N1-P1| + |R_N1-P1|)] x100, where L_N1-P1 = peak-to-peak oVEMP amplitude of the left eye/right ear and R_N1-P1 = peak-to-peak oVEMP amplitude of the right eye/left ear. The oVEMP is a contralateral response; therefore, recordings from the left eye reflect the response of the right ear and vice versa. The amplitudes were calculated from oVEMP responses at a stimulus intensity of 155 dB peakFL. The criterion for abnormal oVEMP was defined as an absent oVEMP or a corrected oVEMP amplitude asymmetry ratio greater than or equal to 40%, either of which would indicate a unilateral vestibular loss. A bilateral vestibular loss was indicated by absent oVEMPs bilaterally."|Up to 20 minutes|Ocular VEMP could not be obtained from 4 participants from the TBI & Blast group.|||percentage of inter-aural asymmetry||Standard Deviation|Mean
2729640|NCT01021137|Primary|Rotary Chair Slow Harmonic Acceleration (SHA) Phase|Rotary chair slow harmonic acceleration (SHA) vestibulo-ocular reflex (VOR) phase at 0.01 Hz was used as a measure of peripheral vestibular function (VOR/horizontal semicircular canal). The phase is the timing difference between the velocity of head movement and the slow-phase eye velocity. This parameter is normalized for a full cycle of a sinusoid (360 degrees) and presented in an angular unit of degrees rather than a unit of time. For perfectly compensatory eye movements the phase is 0 degrees, meaning there is no difference between the actual eye velocity and the ideal VOR (by convention, degrees is added to the phase so that the comparison is based on the ideal VOR responses instead of the actual head motion).|Up to 30 minutes (SHA phase is obtained simultaneously with SHA gain)|Rotary chair slow harmonic acceleration (SHA) phase at 0.01 Hz was not calculated for 2 participants in the TBI & Blast group and 1 participant in the Blast Only group. Phase at 0.01 Hz could not be calculated for individuals with bilateral vestibular loss.|||degrees||Standard Deviation|Mean
2729641|NCT01021137|Primary|Peripheral Vestibular Function (Saccular-collic Pathway): Cervical Vestibular Evoked Potential (cVEMP)|"Air-conducted cervical vestibular evoked potential (cVEMP) inter-ear amplitude asymmetry ratio was used as a measure of otolith organ function (saccular-collic pathway). Inter-ear amplitude asymmetry ratio was calculated as: [(|L_P1-N1| - |R_P1-N1|)/ (|L_P1-N1| + |R_P1-N1|)] x100, where L_P1-N1 = peak-to-peak cVEMP amplitude of the left side and R_P1-N1 = peak-to-peak cVEMP amplitude of the right side. The amplitudes were calculated from cVEMP responses at a stimulus intensity of 120 dB peakSPL. The criterion for abnormal cVEMP was defined as an absent cVEMP or a corrected cVEMP amplitude asymmetry ratio greater than or equal to 40%, either of which would indicate a unilateral vestibular loss. A bilateral vestibular loss was indicated by absent cVEMPs bilaterally."|Up to 30 minutes|Cervical VEMP could not be evaluated on 2 participants in the TBI & Blast group and 3 participants in the Blast Only group.|||percentage of inter-ear asymmetry||Standard Deviation|Mean
2729642|NCT01021137|Primary|Rotary Chair Slow Harmonic Acceleration (SHA) Gain|Rotary chair slow harmonic acceleration (SHA) vestibulo-ocular reflex (VOR) gain at 0.01 Hz was used as a measure of peripheral vestibular function (VOR/horizontal semicircular canal). VOR gain is defined as the ratio of the slow component velocity eye movement (output) to the velocity of the head movement (input).|up to 30 minutes|Rotary chair slow harmonic acceleration (SHA) VOR gain at 0.01 Hz was not evaluated in 1 participant in the TBI & Blast group.|||Unitless||Standard Deviation|Mean
2729643|NCT01021137|Primary|Peripheral Vestibular Function (Vestibulo-ocular Reflex/Semicircular Canal): Caloric Weakness|"The caloric weakness was determined using monothermal warm inter-ear difference (MWIED) which was calculated as: (|RW| - |LW| )/( |RW| + |LW|) x 100, where RW = the maximum slow phase velocity (SPV) of nystagmus induced by warm water irrigation in the right ear and LW = the maximum SPV of nystagmus induced by warm water irrigation in the left ear. For participants with MWIED > 10, then cool caloric irrigation was also performed and caloric weakness was determined using a bithermal inter-ear difference (BIED) calculated as: (|RW| + |RC|) - (|LW| + |LC|) / (|RW| + |RC| + |LW| + |LC|) x 100, where RC = maximum SPV of nystagmus induced by cool water irrigation in the right ear and LC = maximum SPV of nystagmus induced by cool water irrigation in the left ear."|up to 30 minutes|Caloric weakness could not be obtained from 1 participant in the Blast Only group and 2 participants in the Healthy Control group.|||percentage of caloric weakness||Standard Deviation|Mean
2729644|NCT01021111|Secondary|Thigh Coronal Angular Velocity After Feedback Training|How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.|1 day||||degrees/second||Standard Deviation|Mean
2729645|NCT01021111|Primary|Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback|Knee flexion angle describes the angle between the tibia and femur during the activity. Trunk flexion is the angle between the shoulders and the hips during the activity.|1 day||||degrees||Standard Deviation|Mean
2755442|NCT00839241|Secondary|TNF-Alpha||Day 8 postop||||pg/mL||Standard Deviation|Mean
2729646|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Colchicine(fasted)-could not be determined for Subject 25. Colchicine(high-fat meal)-could not be determined for Subjects 22,25, and 28. Colchicine/Probenecid(fasted)-could not be determined for Subject 25.|||pg-hr/mL||Standard Deviation|Mean
2729647|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose||||pg-hr/mL||Standard Deviation|Mean
2729648|NCT01021020|Primary|Maximal Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose||||pg/mL||Standard Deviation|Mean
2729649|NCT01021007|Primary|Plaque Index (Quigley-Hein Score)|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||Units on a scale||Standard Deviation|Mean
2729650|NCT01021007|Primary|EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale|0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 & 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.|6 weeks||||bleeding sites||Standard Deviation|Mean
2729651|NCT01021007|Primary|Gingival Index|1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding|6 weeks||||Units on a scale||Standard Deviation|Mean
2729652|NCT01020981|Secondary|PTSD Symptoms|"The PCL is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The PCL-M is a military version and questions refer to a stressful military experience. Total possible scores range from 17 to 85. Higher scores indicate more symptoms of PTSD and a cut-off score of 50 is used for indicating a probable diagnosis of combat-related PTSD."|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|86% of MI NG soldiers who completed surveys returned a complete PCL scale and 87% of IN NG soldiers who completed surveys returned a complete PCL scale.|||units on PCL scale||Standard Deviation|Mean
2729653|NCT01020981|Secondary|Depressive Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|Data were analyzed for those with complete outcome data. Thus, 1 participant in Michigan Army National Guard and 1 participant in Indiana Army National Guard are not included in these results.|||units on a BDI-II scale||Standard Deviation|Mean
2729654|NCT01020981|Primary|Feasibility-response Rate|Response rate of Soldiers to a mailed survey.|Survey was fielded to Michigan National Guard Service Members on three occasions, March 2011, April 2011, and May 2011. The survey was also fielded to Indiana National Guard Service Members on September 2011, October 2011, and November 2011.|"8 or 5% of surveys to Michigan NG Soldiers were not deliverable. 32 (21%) of Indiana NG soldier surveys were not deliverable.~66 of 142 delivered surveys to MI soldiers were returned for a response rate of 46%. 60 of 118 deliverable surveys to Indiana NG Soldiers were returned for a response rate of 51%."|||% of Soldiers returning mailed survey|||Number
2729655|NCT01020903|Primary|Post-operative Nausea and Vomiting|Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.|1 year|"Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to 0."||||||
2729656|NCT01020877|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2729657|NCT01020877|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2729658|NCT01020877|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.|||ng/mL||Standard Deviation|Mean
2729665|NCT01020812|Secondary|Median Progression Free Survival|Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.|18 months||||months||95% Confidence Interval|Median
2755443|NCT00839241|Secondary|TNF-Alpha||Day 5 postop||||pg/mL||Standard Deviation|Mean
2729659|NCT01020838|Secondary|Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans|Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans.|90-110 minutes post injection (PET image acquisition)||||Standardized Uptake Value Ratio (SUVR)||Standard Deviation|Mean
2729660|NCT01020838|Secondary|Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.|Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.|90-110 minutes post injection (PET image acquisition)|Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs.|||percentage of subjects|||Number
2729661|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3)."|||percentage of subjects||95% Confidence Interval|Number
2729662|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2)."|||percentage of subjects||95% Confidence Interval|Number
2729663|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1)."|||percentage of subjects||95% Confidence Interval|Number
2729664|NCT01020838|Primary|Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens|"The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as normal or abnormal depending on the presence or absence of regional tracer uptake in the respective region. Normal therefore meant absence of β-amyloid and abnormal presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was β-amyloid present. Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|All participants included in the Interim Analysis Set were included in this analysis.|||percentage of regions|||Number
2729667|NCT01020812|Secondary|To Determine the Progression-free Survival of TACE and SBRT at 18 Months|Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.|18 months|All patients who completed the treatment|||survival probability at 18 months|||Number
2729668|NCT01020812|Primary|Freedom From Local Progression of TACE and SBRT at 12 Months|Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.|12 months|All patients who completed treatment|||proportion of participants||95% Confidence Interval|Number
2729669|NCT01020799|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline|HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
2729670|NCT01020799|Secondary|Clinical Global Impression - Severity (CGI-S) Score Change From Baseline|"CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 (Normal, not ill) to 7 (Among the most extremely ill patients). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]"|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
2729671|NCT01020799|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.|HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
2729672|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Remission|Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4||||Participants|||Number
2729673|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Response|Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4||||Participants|||Number
2729674|NCT01020799|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.|MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
2729675|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period|"Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants||95% Confidence Interval|Number
2729676|NCT01020786|Secondary|Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period|"Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants||95% Confidence Interval|Number
2729685|NCT01020747|Primary|The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period.|Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.|6 months|All subjects were analyzed.|||total percentage change||Standard Deviation|Mean
2729686|NCT01020591|Secondary|The Knee Flexion Active Range of Motion, Balance and Pain (VAS)||Jan 2010 to March 2010|||||||
2755444|NCT00839241|Secondary|TNF-Alpha||Baseline||||pg/mL||Standard Deviation|Mean
2729677|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period|"Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.|||percentage of participants||95% Confidence Interval|Number
2729678|NCT01020786|Secondary|Overall Survival (OS) During the Maintenance Therapy Period|OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively.|||months||95% Confidence Interval|Median
2729679|NCT01020786|Secondary|Progression Free Survival (PFS) During the Maintenance Therapy Period|"Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)|Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off.|||months||95% Confidence Interval|Median
2729680|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants|||Number
2729681|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants||95% Confidence Interval|Number
2729682|NCT01020786|Secondary|Overall Survival (OS) During the Induction and Maintenance Therapy Periods|OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.|Enrollment to the date of death from any cause (up to 30.8 months)|Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off.|||months||95% Confidence Interval|Median
2729683|NCT01020786|Primary|Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods|"PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD.|||months||95% Confidence Interval|Median
2729684|NCT01020773|Primary|Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality||13 months||||participants|||Number
2741863|NCT00939211|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h||||mmHg||Standard Deviation|Mean
2729687|NCT01020591|Primary|Resistive Index (RI)|Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.|Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day||||ratio||Standard Deviation|Mean
2729688|NCT01020526|Primary|Change From Baseline in Pain Numeric Rating Scale by Week|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.|Baseline, Weeks 3, 8, 16, 24 and Last Visit.|This population will include all participants who have received at least one dose of study medication.|||Number||Standard Deviation|Mean
2729689|NCT01020474|Secondary|Proportion of Patient Global Impression Change (PGIC) at Week 15|Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.|||percentage of participants|||Number
2729690|NCT01020474|Secondary|Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.|||percentage of participants|||Number
2729691|NCT01020474|Secondary|Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.|||percentage of participants|||Number
2729692|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.|||Units on a scale||Standard Error|Least Squares Mean
2729693|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)|"Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep."|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2729694|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)|Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2729695|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Sleep Quality Diary Score|"Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep."|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.|||Units on a scale||Standard Error|Least Squares Mean
2729696|NCT01020474|Primary|Change From Baseline to Week 15 in Mean Pain Diary Score|"The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (no pain) and 10 (worst possible pain)."|Week 15|The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2729697|NCT01020448|Secondary|Safety, Assessed Through the Collection of Adverse Events (AEs)||For the duration of the study (up to month 6)||||participants|||Number
2729698|NCT01020448|Secondary|PSA Level||At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.|||μg/L||Full Range|Median
2729699|NCT01020448|Secondary|Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)||At month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.|||percentage of participants|||Number
2729720|NCT01020123|Secondary|Pulse, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 236 in CSR)|||Beats/min||Standard Deviation|Mean
2729700|NCT01020448|Secondary|TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)|"TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000~A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'"|At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.|||participants|||Number
2729701|NCT01020448|Secondary|PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000~Non-assessable = Associated PSA mRNA <7500 copies/mL~≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL~<35 = PCA-3 mRNA above BLQ and less than 35~≥35 = PCA-3 mRNA greater or equal to 35"|At month 1 and 3 post-treatment|Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.|||participants|||Number
2729702|NCT01020448|Primary|PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000~Non-assessable = Associated PSA mRNA <7500 copies/mL~≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL~<35 = PCA-3 mRNA above BLQ and less than 35~≥35 = PCA-3 mRNA greater or equal to 35"|At month 6 post-treatment|Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No post-baseline assessment was available for this patient.|||participants|||Number
2729703|NCT01020435|Other Pre-specified|Study Duration From Launch Date to Final Outcomes|To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. Feasibility measured by and duration of study from launch date to final outcomes.|19 months|51 participants were enrolled; however, the table below shows the number enrolled and consented before the 51 were enrolled. The final row of data shows, 19, signifying the study duration in MONTHS (October 2010 - April 2012).|||months|||Number
2729704|NCT01020435|Other Pre-specified|Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study|To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. Feasibility measured by: patient recruitment, enrollment, and retention, and duration of study from launch date to final outcomes.|19 months|In this study, participants are not allocated to a treatment arm until they have met all eligibility criteria through the Final Case Review. Because of this it is not possible to report feasibility outcomes by treatment arm.|||# participants|||Number
2729705|NCT01020435|Primary|Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6|"To estimate the effect size and variability of change in systolic (SBP) and/or diastolic blood pressure (DBP) over a six week treatment period to use in planning a full-scale randomized controlled trial and to assess the believability of the placebo manipulation.~The table shows the unadjusted and adjusted mean change in SBP and DBP from baseline to after Treatment 1 (Tx 1), 3 (Wk 3), and 6 (Wk 6) Weeks.~Adjusted values were adjusted for age, sex, BMI, and respective baseline blood pressure.~Wk 3 and Wk 6 DBP were also adjusted for stage of blood pressure (prehypertension or Stage 1 hypertension)."|Baseline after 1, 3, and 6 Weeks of treatment||||mmHg||95% Confidence Interval|Mean
2729706|NCT01020305|Primary|Reduction in Serum PSA|Proportion of subjects with > 50% drop in serum PSA as compared to baseline, assessed at 16 weeks|12 weeks treatment, with primary outcome assessed at 16 weeks||||participants|||Number
2729707|NCT01020123|Secondary|EC50 to Characterise the PD Properties of AZD1656.|The value is model based. The value is independent treatment given.|at 4 month||||nmol/L||Standard Error|Mean
2729708|NCT01020123|Secondary|CL/F to Characterise the PK Properties of AZD1656.|The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.|at 4 month||||L/h||Standard Error|Mean
2729709|NCT01020123|Secondary|Bilirubin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 209 in CSR)|||mg/dL||Standard Deviation|Mean
2729710|NCT01020123|Secondary|Alkaline Phosphatase; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 208 in CSR)|||IU/L||Standard Deviation|Mean
2729711|NCT01020123|Secondary|AST; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 207 in CSR)|||IU/L||Standard Deviation|Mean
2729712|NCT01020123|Secondary|ALT; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 206 in CSR)|||IU/L||Standard Deviation|Mean
2729713|NCT01020123|Secondary|Creatinine; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 211 in CSR)|||IU/L||Standard Deviation|Mean
2729714|NCT01020123|Secondary|Potassium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 214 in CSR)|||mEq/L||Standard Deviation|Mean
2729715|NCT01020123|Secondary|Sodium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 215 in CSR)|||mEq/L||Standard Deviation|Mean
2729716|NCT01020123|Secondary|Leukocytes; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 198 in CSR)|||*10^3 cells/µL||Standard Deviation|Mean
2729717|NCT01020123|Secondary|Haemoglobin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|population is safety analysis set regardless of rescue, using the observed cases (see table 197 in CSR)|||g/dL||Standard Deviation|Mean
2729718|NCT01020123|Secondary|QTcF; Electorcardiagram Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 258 in CSR)|||msec||Standard Deviation|Mean
2729719|NCT01020123|Secondary|Weight, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 244 in CSR)|||kg||Standard Deviation|Mean
2729725|NCT01020123|Secondary|Total Cholesterol: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 232 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
2729726|NCT01020123|Secondary|HDL-C: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 230 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
2729727|NCT01020123|Secondary|LDL-C: Mean Ratio|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
2729728|NCT01020123|Secondary|HbA1c ≤ 6.5|Number of Responders ≤ 6.5, FAS Prior to Rescue|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR).|||Participants|||Number
2729729|NCT01020123|Secondary|HbA1c ≤ 7|Number of responders ≤ 7, FAS prior to rescue.|baseline to 4 month|The population is FAS prior to rescue, using the observed cases (see table 35 in CSR).|||Participants|||Number
2729730|NCT01020123|Secondary|OGTT/Pro-insulin/Insulin|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 154 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||Ratio||95% Confidence Interval|Geometric Mean
2729731|NCT01020123|Secondary|OGTT/C-peptide|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 150 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||ratio||95% Confidence Interval|Geometric Mean
2729732|NCT01020123|Secondary|OGTT/Insulin|The Relative Change in AUC FAS Prior to Rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 146 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||ratio||95% Confidence Interval|Geometric Mean
2729733|NCT01020123|Secondary|OGTT/Plasma Glucose|The relative change in AUC|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 142 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||ratio||95% Confidence Interval|Geometric Mean
2729734|NCT01020123|Secondary|SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 31 in CSR)|||mmol/L||95% Confidence Interval|Mean
2729735|NCT01020123|Secondary|FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 29 in CSR)|||mmol/L||95% Confidence Interval|Mean
2729736|NCT01020123|Primary|HbA1c: Change From Baseline to 4 Month|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue|Baseline to 4th Month|The population is FAS prior to rescue, using the LOCF values (see table 27 in CSR)|||Percentage||95% Confidence Interval|Mean
2729737|NCT01020019|Primary|21 Days of Consecutive Abstinence as Measured by the Time-line Followback.||reported daily for 12 weeks/ or study participation||||participants|||Number
2729738|NCT01020006|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0|First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).||||participants|||Number
2729739|NCT01019980|Secondary|The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever||2 hours|||||||
2729740|NCT01019980|Secondary|Safety of Diclofenac Potassium Therapy in the Study Period||6 hours|||||||
2729741|NCT01019980|Secondary|Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours||6 hours|||||||
2729742|NCT01019980|Secondary|Time to Reach a Reduction of Temperature as 0.5 and 1 °C||2 hours|||||||
2729743|NCT01019980|Primary|The Reduction of Temperature||2 hours|||||||
2729744|NCT01019928|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)|Pre-entry to follow-up||||Participants|||Number
2729745|NCT01019928|Secondary|Body Temperature|Oral Body Temperature at 1.5 hours post dose|1.5 hours post dose||||degrees Celsius||Standard Deviation|Mean
2729746|NCT01019928|Secondary|QTcF|QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose|1.5 hours post dose||||ms||Standard Deviation|Mean
2729747|NCT01019928|Secondary|Pulse|Supine Pulse at 1.5 hours post dose|1.5 hours post dose||||beats/min||Standard Deviation|Mean
2729748|NCT01019928|Secondary|DBP|Supine Diastolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose||||mmHg||Standard Deviation|Mean
2729749|NCT01019928|Secondary|SBP|Supine Systolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose||||mmHg||Standard Deviation|Mean
2729750|NCT01019928|Secondary|Tmax|Time of maximum plasma concentration|0 to 4 hours post dose||||hours||Full Range|Median
2729751|NCT01019928|Secondary|Cmax|Maximum plasma concentration|0 to 4 hours post dose||||nmol/L||95% Confidence Interval|Geometric Mean
2729752|NCT01019928|Secondary|AUCt|Area under the plasma concentration curve from time zero to the last quantifiable concentration|0 to 4 hours post dose||||nmol*h/L||95% Confidence Interval|Geometric Mean
2741864|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose|15 min FEV1 value|15 min||||L||Standard Deviation|Mean
2729753|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose||||mA||Full Range|Geometric Mean
2729754|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose||||mA||Full Range|Geometric Mean
2729755|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose||||mA||Full Range|Geometric Mean
2729756|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose||||ml||Full Range|Geometric Mean
2729757|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose||||ml||Full Range|Geometric Mean
2729758|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose||||ml||Full Range|Geometric Mean
2729759|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose||||seconds||Full Range|Geometric Mean
2729760|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose||||seconds||Full Range|Geometric Mean
2755445|NCT00839241|Secondary|Interleukin-10||Day 8 postop||||pg/mL||Standard Deviation|Mean
2729761|NCT01019928|Primary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose||||seconds||Full Range|Geometric Mean
2729762|NCT01019707|Primary|Heart Rate|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion||||BPM|Timepoints|Standard Deviation|Mean
2729763|NCT01019707|Primary|Diastolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion||||mm Hg|Timepoints post infusion|Standard Deviation|Mean
2729764|NCT01019707|Primary|Systolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion||||mm Hg|Timepoints|Standard Deviation|Mean
2729765|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization||48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||participants|||Number
2729766|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations||48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||participants|||Number
2729767|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
2729768|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
2729769|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
2729770|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
2729771|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
2729772|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Deviation|Mean
2729773|NCT01019694|Secondary|Change From Baseline in FVC at Week 48|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729774|NCT01019694|Secondary|Change From Baseline in FVC at Week 24|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729775|NCT01019694|Secondary|Change From Baseline in FVC at Week 12|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729776|NCT01019694|Secondary|Change From Baseline in FVC at Day 1|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729777|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 48|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729778|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 24|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729779|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 12|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2729780|NCT01019694|Secondary|Change From Baseline in FEV1 at Day 1|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
2742841|NCT00932126|Secondary|Baseline Tumor Expression of PAK-related Pathway Molecules and Other Known Biomarkers||Baseline|Data not analyzed due to early study termination.||||||
2729781|NCT01019694|Secondary|Physician's Global Evaluation at Week 48|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729782|NCT01019694|Secondary|Physician's Global Evaluation at Week 36|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729783|NCT01019694|Secondary|Physician's Global Evaluation at Week 24|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729784|NCT01019694|Secondary|Physician's Global Evaluation at Week 12|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729785|NCT01019694|Secondary|Physician's Global Evaluation at Week 3|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729786|NCT01019694|Secondary|Physician's Global Evaluation at Week 0|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||units on a scale||Standard Deviation|Mean
2729787|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729788|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729789|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729790|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729791|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729792|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||units on a scale||Standard Deviation|Mean
2729793|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729794|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729795|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729796|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729797|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729798|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||units on a scale||Standard Deviation|Mean
2735787|NCT00978562|Secondary|Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
2729799|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729800|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729801|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729802|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729803|NCT01019694|Primary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
2729804|NCT01019486|Secondary|Myocardial Perfusion Index|Myocardial perfusion indices radionuclide stress and rest images and were obtained from 6 regions within the mid ventricular LV short axis slice. Each was corrected for decay and standardized to a 30 mCi administered dose for each part of a two day study.|1 month||||percentage of Ratio Stress/ rest counts||Standard Deviation|Mean
2729805|NCT01019486|Secondary|Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.|Regional coronary blood flow reserve (CFR) in a target artery (defined on MPI study) compared to flow in a less diseased atherosclerotic vessel following vasodilator response to intravenously administered regadenoson.|within 6 months|Only 3 individuals met the prescribed perfusion defect on MPI study to proceed to the CFR measurement arm of the study. Therefore numbers were too small for statistical comparison and only mean value and standard deviation of the flow ratio(CFR measurements) are reported..|||CFR ratio||Standard Deviation|Mean
2729806|NCT01019486|Primary|Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.|Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.|1 month|"Determine the MBF obtained from cardiac MRI from 6 regions of the mid-ventricular LV myocardium and a ratio between stress/rest myocardial blood flow ratio. Differences between group were compared using a unpaired t test analyzed for: control(Con) vs T1DM low risk; Con. vs T1DM High Risk; and T1DM low vs high risk."|||percentage of StressMBF/ Rest MBF||Standard Deviation|Mean
2729807|NCT01019369|Secondary|Average Minutes Spent Getting Ready for and Giving the Injection|In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.|0-12 months|Data were not collected. No analysis was performed.||||||
2729808|NCT01019369|Secondary|Scaled Satisfaction Score|This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.|6, 12 months|Data were not collected. No analysis was performed.||||||
2729809|NCT01019369|Secondary|Prevalence of Participants With Persistent Skin Changes|The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)|12 months|Data were not collected. No analysis was performed.||||||
2729810|NCT01019369|Secondary|Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available|The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA|6, 12 months|Data were not collected. No analysis was performed.||||||
2729811|NCT01019369|Secondary|Number of Participants Continuing DMPA|The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.|3, 9, 12 months|115 women w 12 month follow-up data (76 and 39) . 10 participants LTFU in self-administration group, and 7 participants LTFU in the clinic administration group.|||Participants|||Count of Participants
2729812|NCT01019369|Primary|Number of Participants Continuing DMPA at 6 Months|The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA|6 months|"Data was analyzed with the assumption that participants who were lost to follow-up had discontinued DMPA use."|||participants|||Number
2729813|NCT01019317|Primary|Participants With a Complete Response|Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.|Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)|Of participants enrolled, 147 participants received treatment and were evaluable.|||Participants|||Number
2729825|NCT01018992|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.|||Score on a scale||Standard Deviation|Mean
2729814|NCT01019252|Primary|Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report|-Independent blinded evaluator rated parent report of symptom severity (ADHD Rating Scale-IV) to the parent of the adolescent participant. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.|baseline, 4-months, and 8-months|The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).|||units on a scale||Standard Deviation|Mean
2729815|NCT01019252|Primary|Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating|-Independent, blinded evaluator rating of ADHD symptom severity (Clinical Global Impressions - severity scale). The Clinical Global Impression (CGI) Scale is a widely used rating scale to measure overall severity related to ADHD symptoms. The Global Severity rating ranges from; 1=not ill, to 7= extremely ill, with higher scores indicating greater severity.The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.|before randomization, 4-months, 8-months|The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).|||units on a scale||Standard Deviation|Mean
2729816|NCT01019252|Primary|Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report|-Independent blinded evaluator rated adolescent report of symptom severity (Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV). The independent evaluator administered the ADHD rating scale-IV to adolescent participants. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.|before randomization, 4-months, 8-months|The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).|||units on a scale||Standard Deviation|Mean
2729817|NCT01019135|Secondary|Smoking|Current smoking status|6 months|Participants with available data for current smoking status. Reported values in the table represent number of participants who were current smokers.|||Participants|||Number
2729818|NCT01019135|Secondary|Medication Adherence|The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.|6 months|Participants with available data for medication adherence|||Scores on a scale||Standard Deviation|Mean
2729819|NCT01019135|Secondary|Diet|"The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt.~Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range."|6 months|Participants with available data for diet|||Scores on a scale||Standard Deviation|Mean
2729820|NCT01019135|Secondary|Self-reported Exercise|"The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is active. There is no max score."|6 months|Participants with available data for self-reported exercise|||Scores on a scale||Standard Deviation|Mean
2729821|NCT01019135|Secondary|Exercise|Mean daily steps as measured by a pedometer over 7 days|6 months|Participants with available data for exercise|||Daily steps||Standard Deviation|Mean
2729822|NCT01019135|Secondary|Exercise Capacity|Exercise capacity as measured by VO2peak on a graded stress test.|6 months|Participants with available data for exercise capacity|||mL/(kg·min)||Standard Deviation|Mean
2729823|NCT01019135|Primary|CR Program Adherence||6 months|Participants with available data for adherence|||percentage of sessions attended||Standard Deviation|Mean
2729824|NCT01018992|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Week 6|Intent to Treat|||participants|||Number
2729841|NCT01018953|Secondary|Minimum Concentration (Cmin) BIM 23A760 Plasma Levels||At 9 timepoints up to 1 week after 24th administration in week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
2755446|NCT00839241|Secondary|Interleukin-10||Day 5 postop||||pg/mL||Standard Deviation|Mean
2729826|NCT01018992|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6|Intent to treat analysis was performed with missing subjects considered to be non-responders.|||participants|||Number
2729827|NCT01018992|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.|||Score on a scale||Standard Deviation|Mean
2729828|NCT01018979|Secondary|Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion||||cells/μL||Standard Deviation|Mean
2729829|NCT01018979|Secondary|Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||mL/kg||Standard Deviation|Mean
2729830|NCT01018979|Secondary|Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||mL/kg||Standard Deviation|Mean
2729831|NCT01018979|Secondary|Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||mL/ hr/kg||Standard Deviation|Mean
2729832|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr*ng/mL||Standard Deviation|Mean
2729833|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr*ng/mL||Standard Deviation|Mean
2729834|NCT01018979|Secondary|Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||1/hr||Standard Deviation|Mean
2729835|NCT01018979|Secondary|Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr||Standard Deviation|Mean
2729836|NCT01018979|Secondary|Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr||Standard Deviation|Mean
2729837|NCT01018979|Secondary|Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion||||fold||Standard Deviation|Mean
2729838|NCT01018979|Secondary|Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||ng/mL||Standard Deviation|Mean
2729839|NCT01018979|Primary|Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).|Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.|1 week|"In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure.~In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure."|||participants|||Number
2729840|NCT01018953|Secondary|Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels||At 8 timepoints up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
2735803|NCT00978419|Secondary|A Reduction in CK Levels Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14, 21, 28||28 days|||||||
2729842|NCT01018953|Secondary|Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)||Up to week 26|Both ITT (Intent-To-Treat) and safety populations were the same analysis group. Treatment emergent adverse events (TEAE) reported by 2 or more patients (safety population) by primary system organ class.|||Participants|||Number
2729843|NCT01018953|Secondary|Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
2729844|NCT01018953|Secondary|Change in the Quality of Life (QoL) Assessment||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
2729845|NCT01018953|Secondary|Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)||Up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
2729846|NCT01018953|Primary|Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale|Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)|Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
2729847|NCT01018862|Secondary|Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo|change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2729848|NCT01018862|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2729849|NCT01018862|Secondary|Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2729850|NCT01018862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2729851|NCT01018810|Secondary|Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks|Measures anti-LY2525263 antibody as positive or negative. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||participants|||Number
2729852|NCT01018810|Secondary|Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks|Area under the curve of serum drug concentration, including absolute bioavailability. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and in each treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2729853|NCT01018810|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks|A 14-item questionnaire with anxiety and depression subscales; 21 maximum score. Scores of 11+ on either subscale (significant case of psychological morbidity); 8-10 (borderline); 0-7 (normal). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729854|NCT01018810|Secondary|Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729855|NCT01018810|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks|10-item, validated questionnaire covers 6 domains. Responses range from 0 (not at all) to 3 (very much); totals range from 0 to 30 (more impairment). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729905|NCT01018511|Secondary|Apparent Clearance (CL/F) of Tamsulosin||Week 4, Week 8 and Week 12|"Pharmacokinetics Analysis Set (PKAS)- randomized participants who received at least 1 dose of double-blind study drug and had at least 1 quantifiable plasma concentration of tamsulosin OCAS and/or solifenacin. N indicates the number of participants with available data at each timepoint."|||L/h||Geometric Coefficient of Variation|Geometric Mean
2729856|NCT01018810|Secondary|Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks|A scale measures patient perception of psoriatic condition with a continuous range of 0 (good) to 5 (severe). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729857|NCT01018810|Secondary|Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks|A global estimate of pain caused by joint disease on arising made by the subject by placing a vertical mark or tick on a 100-mm VAS from not present to worse, range from 0 to 100mm. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||millimeters (mm)||Standard Deviation|Mean
2729858|NCT01018810|Secondary|Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks|The rPGA rates the subject's psoriasis relative to baseline as 1 (100% clearing), 2 (excellent; 75%-99% clearing), 3 (good; 50%-74% clearing), 4 (fair; 25%-49% clearing), 5 (poor; 0%-24% clearing), or 6 (worsening). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
2729859|NCT01018810|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24|PASI combines body-surface assessments and severity of desquamation, erythema, and plaque induration/infiltration. Overall score:0(no psoriasis) to 72(severe disease). Percent(%) improvement=(baseline PASI-observed PASI)/baseline PASI*100. Study BDAD was terminated after enrolling only 8 patients. Least Squares (LS) Mean Values were adjusted for time, treatment, and baseline. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||percentage of units on a scale||95% Confidence Interval|Least Squares Mean
2729860|NCT01018810|Primary|Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12|PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||percentage of participants|||Number
2729861|NCT01018732|Secondary|Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination|Local and systemic reactions were solicited to assess safety and tolerability of vaccination|Up to Day 7||||participants|||Number
2729862|NCT01018732|Secondary|Percentage of Subjects With hSBA Seroresponse After Booster Vaccination|For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2729863|NCT01018732|Secondary|Geometric Mean Ratio After Booster Vaccination|Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1|Day 8 and Day 29 (at 5 Years After Primary Vaccination)|full analysis set|||Geometric mean ratio||95% Confidence Interval|Mean
2729864|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set|||Percentage of participants||95% Confidence Interval|Number
2729865|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set|||Percentage of participants||95% Confidence Interval|Number
2729866|NCT01018732|Secondary|Geometric Mean Titer at 5 Years After Primary Vaccination|Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set|||Titer||95% Confidence Interval|Geometric Mean
2729867|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination|Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2729906|NCT01018511|Secondary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.|||mL/s||Standard Deviation|Mean
2755447|NCT00839241|Secondary|Interleukin-10||Baseline||||pg/mL||Standard Deviation|Mean
2729868|NCT01018732|Primary|Geometric Mean Titer After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set|||Titer||95% Confidence Interval|Geometric Mean
2729869|NCT01018732|Primary|Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination|Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination)|Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).|||Percentage of participants||95% Confidence Interval|Number
2729870|NCT01018680|Other Pre-specified|Percentage of Participants With a Change of Better, Worse, or No Change in Health Outcomes as Measured by Resource Utilization (REU) up to 10 Weeks|"REU captures information regarding the participant's work status and/or health care utilization. Investigators gather information from medical records, psychiatric history, and direct questioning of the participant and his or her family to complete the questionnaire. Responses to each item, comparing baseline to endpoint, are characterized as Better, Same, or Worse. Better: an increase in time spent working/volunteering/holding a job, decrease in number of health care visits; Same: no change in time spent working/volunteering/holding a job, no change in number of health care visits; Worse: decrease in time spent working/volunteering/holding a job, increase in number of health care visits."|Up to 10 weeks|Intent-to-treat (ITT) participants with a baseline and at least 1 post-baseline REU value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
2729871|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Pulse Rate up to 10 Weeks|Abnormal pulse rate (tachycardia) is defined as a sitting heart rate (HR) ≥ 100 beats per minute (bpm) that is also ≥ 10 bpm compared to baseline, at last visit if highest baseline HR < 100 bpm.|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline pulse rate value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
2729872|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) up to 10 Weeks|"Abnormal DPB (diastolic hypertension) is defined as sitting DBP ≥ 90 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline DBP < 90 mm Hg.~Abnormal SBP (systolic hypertension) is defined as sitting SBP ≥ 140 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline SBP < 140 mm Hg."|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline DBP and SBP value, last-observation-carried forward (LOCF) were included in the analysis. Participants with a normal baseline value and a nonmissing endpoint value for the variable of interest were included in the analysis.|||percentage of participants|||Number
2729873|NCT01018680|Secondary|Percentage of Participants Who Discontinued Due to an Adverse Event During the 10-Week Treatment Period||Baseline through 10 weeks|All randomized participants were included in the analysis.|||percentage of participants|||Number
2729874|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Weight Gain and Weight Loss up to 10 Weeks|"Abnormal weight gain (potentially clinically significant [PCS] weight gain) is defined as weight gain at last visit ≥ 7% of the baseline weight.~Abnormal weight loss (PCS weight loss) is defined as weight loss at last visit ≥ 7% of the baseline weight."|Up to 10 weeks|Participants with a baseline and at least 1 post-baseline weight value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
2729875|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal High Hemoglobin A1c (HbA1c) up to 10 Weeks|Abnormal high HbA1c is defined as a post-baseline HbA1c > 6.1% if baseline HbA1c ≤ 6.1% for lab samples obtained before November 17, 2010 and post-baseline HbA1c > 6.4% if baseline HbA1c ≤ 6.4% for lab samples obtained November 17, 2010 and beyond.|Up to 10 weeks|Number of participants with a normal baseline and at least 1 post-baseline abnormal HbA1C value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
2729876|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Brief Pain Inventory-Severity (BPI-S) Average Pain Score up to 8 Weeks|Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for BPI-S average pain rating. The BPI-S self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S average pain value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
2729877|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Weekly Mean of the 24-Hour Average Pain Score up to 8 Weeks|"Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for the weekly mean of the 24-hour average pain ratings. The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain rating assessed on an 11-point numeric rating scale, with scores from 0 (no pain) to 10 (worst possible pain)."|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean of the 24-hour average pain score value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
2729907|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.|||mL/s||Standard Deviation|Mean
2729908|NCT01018511|Secondary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline PVR volume measured.|||mL||Standard Deviation|Mean
2755448|NCT00839241|Secondary|Interleukin-6||Day 8 postop||||pg/mL||Standard Deviation|Mean
2729878|NCT01018680|Secondary|Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks|"OARSI response is composite Yes/No response assessed at 8 weeks based on decrease in 24-hour average pain ratings, range: 0 (no pain) to 10 (worst possible pain), improvement in functioning (using WOMAC physical function scores, range: 0 [no difficulty] to 68 [extreme difficulty]), and improvement in participant's impression of illness (using PGAI scores, range: 0 to 10; 10=greatest severity). OARSI responder=large response in pain or function components (50% relative and 20% absolute improvement), or moderate response (20% relative and 10% absolute improvement) in 2 of 3 components."|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline OARSI response value, last-observation-carried forward (LOCF) based on values of each of the 3 components listed in the outcome measure description were included in the analysis.|||percentage of responders|||Number
2729879|NCT01018680|Secondary|Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period|The Least Squares (LS) Mean percentage estimates of participants using acetaminophen was determined during each week individually over the full 10-week treatment period based on participant's daily Yes/No assessments for the use of acetaminophen. The LS Mean estimates for the main effect of treatment (average weekly use) were adjusted for baseline value, treatment, investigator (pooled), week, and treatment*week.|Baseline through 10 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly acetaminophen use value were included in the analysis.|||percentage of participants||Standard Error|Least Squares Mean
2729880|NCT01018680|Secondary|Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks|30-item BPOMS measures positive and negative aspects of mood states (item score: 0=not at all to 4=extremely). 5 negative factors: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; 1 positive factor: vigor-activity. Factor scores range: 0 to 20; high scores=negative mood (positive mood for vigor). Total score=sum of 5 negative factor scores minus vigor score; range: -20=least disturbed to 100=most disturbed. Least Squares Mean estimates adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPOMS value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729881|NCT01018680|Secondary|Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks|The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline PGAI value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729882|NCT01018680|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks|The CGI-S scale evaluates the severity of illness at the time of assessment. The scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S must be administered by a study physician in the presence of the participant or after having been in the presence of the participant. The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline CGI-S value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729883|NCT01018680|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks|Measures pain severity and pain interference with function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Mean interference is the average across the 7 interference items. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S/BPI-I value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729884|NCT01018680|Secondary|Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks|"Weekly mean 24-hour night pain and worst pain values are calculated from the participant's daily assessments of pain at night and worst pain during the previous 24 hours on an 11-point numeric rating scale, with scores from 0 (indicating no pain) to 10 (indicating the worst possible pain). The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), week, treatment*week, and baseline*week."|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline night/worst pain value and at least 1 post-baseline weekly mean 24-hour night/worst pain value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729885|NCT01018680|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks|Self-administered questionnaire captures elements of pain, stiffness, and physical disability in participants with osteoarthritis of the knee and/or hip. Index has 24 questions (5 on pain, 2 on stiffness, 17 on physical function). Each question uses a 5-point numeric rating scale ranging from 0 (none) to 4 (extreme). Pain scores range: 0 to 20. Stiffness scores range: 0 to 8. Physical function scores range: 0 to 68. Higher scores=greater impairment. Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline WOMAC value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2730158|NCT01017029|Secondary|Participants With at Least One Occurrence of Composite Treatment Failure Events|Comparison of 6-months cumulative incidence of composite treatment failure events (BPAR ≥ 2R, rejection with hemodynamic compromise, graft loss, or death) between delayed everolimus arm and immediate everolimus arm|6 months||||participants||95% Confidence Interval|Number
2729886|NCT01018680|Secondary|Patient Global Impression of Improvement (PGI-I) at 8 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares Mean estimates were adjusted for baseline value of Patient Global Impression of Severity (PGI-S), treatment, investigator (pooled), visit, and treatment*visit. The PGI-S measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline PGI-S rating and at least 1 post-baseline PGI-I rating were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729887|NCT01018680|Primary|Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks|"The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain ratings using an 11-point numeric rating scale, with scores from 0 (indicating no pain) to 10 (indicating the worst possible pain). The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), week, treatment*week, and baseline*week."|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean 24-hour average pain value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2729888|NCT01020487|Secondary|Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)|The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.|Baseline and Weeks 4, 8 and 12|Intent-to-treat dataset with available Baseline data, and available data at each time point|||mg/g||Standard Error|Least Squares Mean
2729889|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges|"The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits:~Age 6 - 12: 3.6 - 5.8 mg/dL (1.16 - 1.87 mmol/L); Age 13 - 20: 2.3 - 4.5 mg/dL (0.74 - 1.45 mmol/L)."|Week 12|Intent to treat dataset|||percentage of participants|||Number
2729890|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges|"KDOQI recommends serum calcium is maintained within age appropriate normal ranges:~Age 6 - 12: 9.4 - 10.2 mg/dL (2.35 - 2.55 mmol/L); Age 13 - 20: 8.8 - 10.2 mg/dL (2.20 - 2.55 mmol/L)."|Week 12|Intent to treat dataset|||percentage of participants|||Number
2729891|NCT01020487|Secondary|Part 2: Change From Baseline in iPTH to Each Post-baseline Visit||Baseline and Weeks 2, 4, 8 and 12|Intent to treat dataset with available data at each time point|||pg/mL||Standard Error|Least Squares Mean
2729892|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges|"The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows::~CKD Stage 3: 35 - 69 pg/mL; CKD Stage 4: 70 - 110 pg/mL."|Week 12|Intent to treat dataset|||percentage of participants|||Number
2729893|NCT01020487|Primary|Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH|The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.|12-week double-blind treatment period|The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug.|||percentage of participants|||Number
2729894|NCT01020487|Primary|Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)||Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|All participants enrolled and administered paricalcitol for the PK Portion, Part 1|||ng*hr/mL||Standard Deviation|Mean
2729895|NCT01020487|Primary|Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)||Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1|||ng/mL||Standard Deviation|Mean
2729896|NCT01018511|Secondary|AUCss of Solifenacin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2729897|NCT01018511|Secondary|Tmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||h||Geometric Coefficient of Variation|Geometric Mean
2729898|NCT01018511|Secondary|Cminss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729899|NCT01018511|Secondary|Cmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729900|NCT01018511|Secondary|CL/F of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||L/h||Geometric Coefficient of Variation|Geometric Mean
2729901|NCT01018511|Secondary|Area Under the Curve at Steady State (AUCss) of Tamsulosin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2729902|NCT01018511|Secondary|Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||h||Geometric Coefficient of Variation|Geometric Mean
2729903|NCT01018511|Secondary|Minimum Concentration at Steady State (Cminss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2729904|NCT01018511|Secondary|Maximum Concentration at Steady State (Cmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2755449|NCT00839241|Secondary|Interleukin-6||Day 5 postop||||pg/mL||Standard Deviation|Mean
2729909|NCT01018511|Secondary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.|From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)|Safety Analysis Set (SAF) - consisted of participants who received at least one dose of double blind study drug and for whom any data was reported after intake of the first dose of study drug.|||participants|||Number
2729910|NCT01018511|Secondary|Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729911|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: General Health|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729912|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729913|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2729914|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729915|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729916|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729917|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729918|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
2729919|NCT01018511|Secondary|Percentage of Participants Who Were OAB-q Responders at End of Treatment|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Week 12 (end of treatment)|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||percentage of participants|||Number
2729920|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729921|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729922|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729923|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729924|NCT01018511|Secondary|Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729925|NCT01018511|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729926|NCT01018511|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729927|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS QoL Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729928|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729929|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729930|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.|||pads||Standard Error|Least Squares Mean
2729931|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.|||nocturia episodes||Standard Error|Least Squares Mean
2729932|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.|||incontinence episodes||Standard Error|Least Squares Mean
2729933|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2729934|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency episode at baseline. LOCF imputation was used.|||urgency episodes||Standard Error|Least Squares Mean
2729935|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||mL||Standard Error|Least Squares Mean
2729936|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||mL||Standard Error|Least Squares Mean
2729937|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||micturitions||Standard Error|Least Squares Mean
2729938|NCT01018511|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence~TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and Week 12|FAS population. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729939|NCT01018511|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and Week 12|Full Analysis Set (FAS)-participants who received at least 1 dose of double-blind study drug and had either a total IPSS or TUS at baseline and at least 1 postbaseline total IPSS or TUS. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2729940|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Moxifloxacin)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia's adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after dose||||milliseconds||Standard Deviation|Mean
2729941|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Colchicine)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia's adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to first dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after first dose||||milliseconds||Standard Deviation|Mean
2729942|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose||||ng-hr/mL||Standard Deviation|Mean
2729943|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose||||ng-hr/mL||Standard Deviation|Mean
2729944|NCT01018420|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose||||ng/mL||Standard Deviation|Mean
2729945|NCT01018394|Primary|Tobacco Abstinence at 12 Weeks|Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.|week 12||||participants|||Number
2729946|NCT01018394|Other Pre-specified|Smokeless Tobacco Reduction Greater or Equal to 50%|Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline|baseline, week 4||||percentage of participants|||Number
2729947|NCT01018264|Secondary|Number of Nocturia Episodes Per 24 Hour Period|To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity|12 weeks||||Number of nocturia episodes per 24 hours||Standard Deviation|Mean
2729948|NCT01018264|Secondary|Parkinson's Disease Quality of Life Scale (PDQOL)|This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life.|12 weeks||||units on a scale||Standard Deviation|Mean
2729949|NCT01018264|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total|To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability).|12 weeks||||units on a scale||Standard Deviation|Mean
2729950|NCT01018264|Secondary|Number of Urinary Incontinence Episodes Per 24 Hour Period|This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity.|12 weeks||||Number of incontinence episodes/24 hours||Standard Deviation|Mean
2729951|NCT01018264|Primary|Number of Micturations Per 24 Hour Period|The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries.|12 weeks||||Number of micturations per 24 hours||Standard Deviation|Mean
2729952|NCT01018186|Primary|Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. Holter monitor data were transmitted to a centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||beats per minute||Standard Deviation|Mean
2729953|NCT01018186|Primary|Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart's rhythm while the monitor is worn. At the end of the 24 hour period, the data from the monitor are downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||beats per minute||Standard Deviation|Mean
2729954|NCT01018186|Primary|Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF)|The QT interval is an electrocardiogram (ECG) parameter that represents the electrical depolarization and repolarization of the left and right ventricles of the heart. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the ECG. Corrected QT (QTc) is the QT interval corrected for heart rate by using Bazett's formula (QTcB) and Fridericia's formula (QTcF). 12-lead ECG measurements were perfomed at the following scheduled time points: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the value taken pre-dose at screening. The maximum post-Baseline value was derived using all scheduled, unscheduled, and Early Withdrawal ECG assessments. Maximum change from Baseline was calculated as the maximum post-Baseline value minus the value at Baseline.|Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
2729963|NCT01018186|Primary|Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP)|SBP and DBP were measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum and minimum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2755450|NCT00839241|Secondary|Interleukin-6||Baseline||||pg/mL||Standard Deviation|Mean
2729955|NCT01018186|Primary|Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52|Visual acuity is defined as the acuteness or clearness of vision. The minimum angle of resolution (MAR) is the angle a viewed object subtends at the eye, usually stated in degrees/minutes of arc. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in decimal numbers. The LogMAR scale is used to express the visual acuity in a linear scale as the logarithm to base 10 of the MAR. A lower score indicates better visual acuity; visual acuity decreases with an increasing score. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
2729956|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52|NO is the opalescence of the nucleus (central layer) of the lens. Per LOC III, NO ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
2729957|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52|NC is the color of the nucleus (central layer) of the lens. Per LOC III, NC ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
2729958|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52|C is defined as the opacification of the cortex (outer layer) of the lens. Per LOC III, C ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2729959|NCT01018186|Primary|Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52|Funduscopic examination was performed at Baseline, Week 28, and Week 52 to measure the horizontal cup-to-disc ratio of both eyes. The horizontal cup-to-disc ratio is the ratio of the horizontal diameter of the physiological cup to that of the horizontal diameter of the optic disc. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
2729960|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52|Intraocular pressure (IOP) is the fluid pressure inside the eye. IOP was measured twice for each eye at Baseline, Week 28, and Week 52 using Goldmann Applanation tonometry. The second IOP reading was used for analysis. The number of participants with a change from Baseline in IOP of <0 mmHg, >=0 to <4 mmHg, >=4 to <7 mmHg, >=7 to <11 mmHg, and >=11 mmHg are presented. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2729961|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52|P is defined as the opacification at the back of the lens adjacent to the capsule (or bag) in which the lens sits. An event of P is defined as an increase of >=0.3 from Baseline in LOCS III grade for P in either eye at any time post-Baseline. Per LOC III, P ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2729962|NCT01018186|Primary|Maximum Change From Baseline in Pulse Rate|Pulse rate was measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20,Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population|||Beats per minute||Standard Deviation|Mean
2729964|NCT01018186|Primary|Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline|A detailed oropharyngeal examination was done at all clinic visits for visual/clinical evidence of oral candidiasis over the entire Treatment Period (worst case any time post-Baseline). For participants with visual/clinical evidence of candidiasis during the Treatment Phase of the study, a culture swab was taken and analyzed for infection.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2755451|NCT00839241|Secondary|Interleukin-4||Day 8 postop||||pg/mL||Standard Deviation|Mean
2729965|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 52. The ratio of the Week 52 LSGM to the Baseline LSGM was calculated as the value at Week 52 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 52|UC Population. Only those participants available at the specified time point were analyzed.|||Ratio of LSGM of UCE to Baseline|||Number
2729966|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 28. The ratio of the Week 28 LSGM to the Baseline LSGM was calculated as the value at Week 28 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 28|UC Population. Only those participants available at the specified time point were analyzed.|||Ratio of LSGM of UCE to Baseline|||Number
2729967|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline|A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 12|Urinary cortisol (UC) Population: participants in the ITT Population whose urine samples did not have confounding factors that affected the interpretation of results. These participants were determined prior to breaking the blind. Only those participants available at the specified time point were analyzed.|||Ratio of LSGM of UCE to Baseline|||Number
2729968|NCT01018186|Primary|Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion|"A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the To high and To low categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value became normal, are presented in the To normal or no change category. The normal range for UCE is defined as: 11 to 138 nanomoles per 24 hours (nmol/24 hr) for participants >=18 years of age, 8.3 to 151.7 nmol/24 hr for participants 14 to 17 years of age, and 2.8 to 124.2 nmol/24 hr for participants 12 and 13 years of age."|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2729969|NCT01018186|Primary|Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2729970|NCT01018186|Primary|Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1.0||Standard Deviation|Mean
2729971|NCT01018186|Primary|Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2729972|NCT01018186|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage||Standard Deviation|Mean
2730159|NCT01017029|Secondary|Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group|CMV infection is defined as pp65 antigenemia or DNAemia|6 months|safety population|||participants||95% Confidence Interval|Number
2729973|NCT01018186|Primary|Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2729974|NCT01018186|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2729975|NCT01018186|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2729976|NCT01018186|Primary|Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2729977|NCT01018186|Primary|Number of Participants With Severe Asthma Exacerbations During the Treatment Period|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population|||participants|||Number
2729978|NCT01018186|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication|||participants|||Number
2729979|NCT01018134|Secondary|Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).|"Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~%Body Surface Area Affected the Rule of Nine was be used."|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.|||percentage of Body Surface Area Affected||Standard Deviation|Mean
2729980|NCT01018134|Secondary|Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28|Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.|||units on a scale||Standard Deviation|Mean
2730037|NCT01017731|Secondary|Number of Participants With Drug-Related Adverse Events (AEs)|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline up to data cut off (approximately 105.6 weeks)|Safety population: participants who received any quantity of ramucirumab, regardless of their eligibility for the study.|||participants|||Number
2729981|NCT01018134|Secondary|Mean Change From Baseline in PGA Score at Day 28 Using the ITT|Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.|||units on a scale||Standard Deviation|Mean
2729982|NCT01018134|Primary|Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).|"The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28.~Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.~A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success."|Day 28|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.|||percentage of Participants|||Number
2729983|NCT01018134|Primary|Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28|"The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)~The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population.~On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1.~A score of 0 = Clear or 1= Almost Clear was considered clinical success.~A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response"|28 days|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.|||percentage of participants|||Number
2729984|NCT01018095|Secondary|TV Culture Positive Result|Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.|3 months post-enrollment|Participants who returned for their 3 mo follow up visit|||participants|||Number
2729985|NCT01018095|Primary|TV Culture Positive Result|At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.|test-of-cure visit at 6-12 days post-treatment completion|Participants who returned for their test of cure visit|||participants|||Number
2729986|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 8||||units on a scale||Full Range|Mean
2729987|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 6||||units on a scale||Full Range|Mean
2729988|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 4||||units on a scale||Full Range|Mean
2729989|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 2||||units on a scale||Full Range|Mean
2729990|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Baseline||||units on a scale||Full Range|Mean
2730063|NCT01017536|Secondary|Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools.|Study days 28 and 56|percentage of CD4 or CD8 T-cell response|||percentage of T-cell response||95% Confidence Interval|Median
2735804|NCT00978419|Secondary|Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo, Adjusted for Cardiovascular Co-morbidities||28 days|||||||
2729991|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Multi-Dimensional Anxiety Scale for Children (MASC)|"Multidimensional Anxiety Scale (MAS): Anxiety will be followed using the Multidimensional Anxiety Scale for Children (MASC), which has been developed by Dr. John March at Duke University and is now considered the preferred instrument for rating anxiety. The MASC asks the patient how they have been thinking and acting recently. It has a maximum possible score of 117 and a minimum score of 0. Higher score on this scale indicates greater severity of anxiety in children.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4.|||units on a scale||Standard Deviation|Mean
2729992|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Child Depression Inventory - Short Version (CDI-S) Scale|"Depression Inventory-Short Version (DI-S): Depression severity will be rated by using the Depression Inventory-Short Version (DI-S). This 10 item scale takes about 5 minutes to complete. It has excellent psychometric properties and is designed for repeated administrations over time. The maximum possible score of 20, and a minimum score of 0. Higher score on this scale indicates greater severity of depression in children.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 3). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3.|||units on a scale||Standard Error|Mean
2729993|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the DuPaul Attention Deficit Hyperactivity Disorder Rating Scale.|"DuPaul ADHD Rating Scale: The presence of ADHD symptoms will be assessed using the DSM-IV version of the ADHD rating scale developed by DuPaul. This scale has been normed in large clinical and community samples and has excellent psychometric properties including a test-retest reliability over a 2-week period of 0.93 and significant correlations with direct observations of classroom behavior. The scale has a maximum possible score of 72, and a minimum of 0. The scale ranges from 0 (the best possible outcome) to 70 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6 weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4.|||units on a scale||Standard Deviation|Mean
2729994|NCT01018056|Secondary|The Change From Baseline to 6-week in Plasma Amino Acid Levels|Blood testing was performed at baseline and at each clinic visit. Data shown below reflects baseline Glutamic Acid minus Week 6 Glutamic Acid, and baseline Serine minus Week 6 Serine levels; as acquired from the blood tests during these respective clinic visits.|Baseline and 6 weeks.||||micromol/L||Standard Deviation|Mean
2729995|NCT01018056|Secondary|Changes in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) From Baseline to 6-weeks.|"Secondary outcome for obsessive-compulsive behaviors will be measured by changes in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from baseline to 6-weeks.~The severity of OCD was evaluated using either the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) or Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The (C)Y-BOCS is the most widely used instrument to assess the severity of obsessive-compulsive symptoms in research studies involving children. The (C)Y-BOCS has well established psychometric properties. The scale ranges from 0 (the best possible outcome) to 10 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks||||units on a scale||Standard Error|Mean
2729996|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Patient Global Impression of Improvement (PGI-I).|"Patient Global Impression of Improvement (PGI-I) is a single seven point scale in which the patient/parent is asked to assess the change in overall condition ranging from very much improved to very much worse.~A score of 1 corresponds to very much better; 2 equals much better; 3 denotes a little better; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals a little worse; 6 is much worse; and 7 is very much worse.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that only summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)--this applies to all outcome measures reported in the results."|Baseline and 6 weeks||||units on a scale||Standard Error|Mean
2729997|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Clinical Global Impression -Improvement (CGI-I).|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to very much improved; 2 equals much improved; 3 denotes minimal change; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals minimally worse; 6 is much worse; and 7 is very much worse.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks||||units on a scale||Standard Error|Mean
2730007|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2729998|NCT01018056|Secondary|The Change From Baseline to 6-week Scores for the Yale Global Tic Severity Scale (YGTSS) Total Score.|"i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50), total maximum score is 100. This scale has established validity, as assessed by Dr. Walkup and colleagues and is considered the best currently available scale to rate the severity of tics. This scale ranges from 0 (the best possible outcome) to 100 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks||||units on a scale||Standard Deviation|Mean
2729999|NCT01018056|Primary|The Change From Baseline to 6-week Scores for The Total Tic Subscale (TTS)|"The primary outcome measure is effective tic suppression as determined by the difference in the Total Tic subscale (TTS) scores of the Yale Global Tic Severity Scale (YGTSS) at baseline and 6 weeks.~i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50). The Total Tic Score (TTS: 0-50) has been selected as the primary outcome measure. The scale ranges from 0 (the best possible outcome) to 50 (the worst possible outcome). This scale is considered the best currently available scale to rate the severity of tics. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks||||units on a scale||Standard Deviation|Mean
2730000|NCT01018030|Secondary|Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)|Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.|4 weeks|ITT Population|||participants|||Number
2730001|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730002|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730003|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730004|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730005|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730006|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730008|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730009|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730010|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in PM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730011|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in AM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
2730012|NCT01018030|Secondary|First Time to Symptom Improvement|Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe.|Entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||days||Full Range|Median
2730013|NCT01018030|Primary|Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)|The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of double-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2730014|NCT01017952|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2730015|NCT01017952|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2735805|NCT00978419|Secondary|Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo||28 days|||||||
2730016|NCT01017952|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population|||Participants|||Number
2730017|NCT01017952|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2730018|NCT01017874|Secondary|Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)|The LCSS data included participant ratings of 6 symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) and 3 summary items (overall symptom severity, interference with daily activities, and overall QoL). Participants recorded their ratings for each item, by placing a mark on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (lower symptom burden, less interference with normal activity, or better QoL) to 100 mm (higher symptom burden, more interference with normal activity, or worse QoL). TWQ was evaluated from date of randomization to first date of worsening, defined as a half standard deviation change as determined from the corresponding baseline item score in the pooled treatment group. For participants not known to have worsened or who were lost to follow-up, TWQ was censored at date of the participant's last LCSS assessment.|Every cycle while on-study therapy and at 3 months post last dose|Participants who received at least 1 dose of study treatment and had LCSS data available. Participants censored (Pemetrexed + Cisplatin + Gefitinib, Gefitinib): Loss of appetite (33,59), Fatigue (42,54), Cough (52,65), Dyspnea (51,66), Hemoptysis (69,74), Pain (48,67), Overall symptoms (52,63), Interference (42,59), Overall QoL (51,51).|||months||Full Range|Median
2730019|NCT01017874|Secondary|Duration of Tumor Response|The duration of a complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria was defined as the time from first objective status assessment of CR or PR to the first time of objective disease progression or death as a result of any cause. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared. Participants who were not known to have died or had objective progression of disease as of the data-inclusion cut-off date were censored at the date of the participant's last complete objective progression-free disease assessment prior to that cut-off date.|Date of initial response to the date of measured PD or death up to 34.43 months|A subset of the Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned who had confirmed CR or PR. Pemetrexed + Cisplatin + Gefitinib= 19, Gefitinib= 9.|||months||95% Confidence Interval|Median
2730020|NCT01017874|Secondary|Time to Progressive Disease (TtPD)|TtPD was defined as the time from randomization to the first date of objectively determined progressive disease (PD). For participants who were not known to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, or who had died without objective progression of disease, TtPD was censored at the date of the participant's last objective progression-free disease assessment prior to cut-off date.|Randomization to the first date of measured PD up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed + Cisplatin + Gefitinib (G) =37, G=26.|||months||95% Confidence Interval|Median
2730021|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR was defined as the percentage of randomized participants with overall response of CR, PR or SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared; SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD. PD defined as at least 20% increase in the sum of LD of target, lesions taking as reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions or progression of nontarget lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.|||percentage of participants||95% Confidence Interval|Number
2735806|NCT00978419|Secondary|Mortality Compared to Placebo, Adjusted for Cardiovascular Co-morbidities||90 days|||||||
2735807|NCT00978419|Secondary|Mortality Compared to Placebo||90 days|||||||
2730022|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the percentage of randomized participants having a best overall study response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and the appearance of no new lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.|||percentage of participants||95% Confidence Interval|Number
2730023|NCT01017874|Secondary|Overall Survival (OS)|OS was the duration from randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date for a particular analysis, OS was censored at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date included adverse event date, lesion assessment date, visit date, and last known alive date).|Randomization up to date of death from any cause up to 57.13 months|ITT population: All data from all randomized participants according to the treatment they were assigned.|||months||95% Confidence Interval|Median
2730024|NCT01017874|Primary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.|Randomization to the first date of measured PD or death up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed+Cisplatin+Gefitinib=32, Gefitinib=22.|||months||95% Confidence Interval|Median
2730025|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 3|The area under the concentration versus time curve over the dosing interval at steady state [AUC(tau,ss)] is reported during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 3.|||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2730026|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 2, Day 1|AUC was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Approximately Week 1 (Cycle 2, Day 1)|No participants were analyzed.||||||
2730027|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 15|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 3 (Cycle 1, Day 15)|No participants analyzed.||||||
2730028|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 8|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.||||||
2730029|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 4|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.||||||
2730030|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1|The area under the concentration versus time curve from time 0 to infinity [AUC(0-inf)] is reported during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 1.|||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2730031|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 3|The maximum observed serum concentration of IMC-1121B (ramucirumab) at steady state (Cmax,ss) during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 3.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2730032|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 2|Cmax was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Cycle 2 (predose and 1.25 hours postdose)|No participants were analyzed.||||||
2730033|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 15|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 3 (Cycle 1, Day 15)|No participants were analyzed.||||||
2730034|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 8|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.||||||
2730035|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 4|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.||||||
2730036|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1|Maximum observed concentration of IMC-1121B (ramucirumab) in serum during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 1.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2735808|NCT00978419|Primary|Primary Endpoint: Reduction in CRP Level Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14. The Mean CRP Levels at Specified Days Will be the Endpoints.||Days 1, 3, 7, 14|||||||
2730038|NCT01017731|Primary|Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants|All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration.|Baseline, Cycle 3 (1 cycle=21 days)|Participants who received a full study dose of ramucirumab in Cycle 3 and had at least 1 pretreatment ECG and postinfusion ECG at scheduled times as specified in the protocol.|||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
2730039|NCT01017653|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|18 months||||months||95% Confidence Interval|Median
2730040|NCT01017653|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|16 months|2 patients' response was unknown due to withdrawal from the study before an MRI was performed.|||participants|||Number
2730041|NCT01017653|Secondary|Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity|Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived < 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0|16 months|Insufficient data to analyze the relationship between EGF-R analysis and efficacy or toxicity. Data was not collected for this outcome.|||participants|||Number
2730042|NCT01017653|Secondary|Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose|Average change in corticosteroid dose from baseline to the end of cycle 1.|Baseline and Day 29|Insufficient data to analyze the effect of the treatment regimen on corticosteroid dose. Data was not collected for this outcome.|||mg|||Number
2730043|NCT01017653|Secondary|Safety of Panitumumab in Combination With Irinotecan|Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0|16 months||||participants|||Number
2730044|NCT01017653|Secondary|One-Year Overall Survival|Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.|1 year||||percentage of participants||95% Confidence Interval|Number
2730045|NCT01017653|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).|6 months||||percentage of participants||95% Confidence Interval|Number
2730046|NCT01017601|Secondary|Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.|Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.|||percentage of participants|||Number
2730047|NCT01017601|Secondary|Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.|Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.|||percentage of participants|||Number
2730048|NCT01017601|Secondary|Change From Baseline to Day 30-59 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.|Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.|||units on a scale||Standard Deviation|Mean
2730064|NCT01017536|Secondary|Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)||6 months (day 182) post Study Day 0 vaccination.||||Change in copies/mL over time||95% Confidence Interval|Median
2730049|NCT01017601|Secondary|Change From Baseline to Day 20-29 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.|Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.|||units on a scale||Standard Deviation|Mean
2730050|NCT01017601|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 23 months|All registered participants who have met eligibility criteria and started the treatment.|||Participants|||Count of Participants
2730051|NCT01017601|Secondary|Duration of Response|Duration of response was defined as the time from the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|All participants with the patient's earliest best objective status was first noted to be a CR or PR.|||months||95% Confidence Interval|Median
2730052|NCT01017601|Secondary|Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all non-nodal target lesions and each target lymph node must have reduction in short axis to <1.0 cm.; Partial Response (PR), at least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the Baseline Sum of Diameters; Overall Response (OR) = CR + PR.|Up to 5 years|All registered participants who have met eligibility criteria and started the treatment.|||percentage of participants|||Number
2730053|NCT01017601|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All registered participants who have met eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
2730054|NCT01017601|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from randomization to the disease progression or death (up to 5 years)|All registered participants who have met eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
2730055|NCT01017575|Other Pre-specified|Number of Participants With Grade 3 to 4 Laboratory Abnormalities|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.|From screening up to Week 12 (treatment period)|All treated participants who received at least 1 dose of study therapy.|||Participants|||Number
2730056|NCT01017575|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Baseline up to 30 days after last dose of study drug|All treated participants who received at least 1 dose of study therapy.|||participants|||Number
2730057|NCT01017575|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.|From Week 4 up to Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
2730058|NCT01017575|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24|SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.|Follow up Week 12, Follow up Week 24|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
2730059|NCT01017575|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.|Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
2730060|NCT01017575|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.|Week 4|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
2730061|NCT01017549|Secondary|Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.|Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.|Through 6 months|All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up.|||events|||Number
2730062|NCT01017549|Primary|Number of Participants With Delivery of 34 Gy in 10 Fractions|Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)|measured at end of 10th fraction, usually within 7 days|All patients treated were analyzed|||Participants|||Number
2730065|NCT01017536|Primary|CD4+ Lymphocyte Count|Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease) Change in cells/mm^3 pre-vaccination to Study Day 182|CD4+ counts from samples collected on Study days 0 and 182.||||cells/mm^3||95% Confidence Interval|Median
2730066|NCT01017497|Secondary|Rate of Death Due to Neurologic Causes|The rate of death due to neurologic causes is defined as the percentage of participants whose death is attributable to the progression of neurological disease.|24 months after SRS||||percentage of participants|||Number
2730067|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT) from baseline to 3 months after SRS. The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Change score = score at 3 months after SRS - score at baseline. Negative change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.|||Change in seconds baseline to 3 months||Standard Error|Mean
2730068|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in MMSE scores from baseline to 3 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The minimum score is 0 and teh maximum score is 30 with higher MMSe scores indicating better cognition. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.|||Change in score from baseline to 3 month||Standard Error|Mean
2730069|NCT01017497|Secondary|Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline to 3 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.|||Change in score from baseline to 3 month||Standard Error|Mean
2730070|NCT01017497|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|24 months after SRS||||months||95% Confidence Interval|Median
2730071|NCT01017497|Secondary|12 Month Rate of Distant Brain Metastases|The 12-month rate of distant brain metastases is defined as the percentage of participants with the appearance of new brain metastasis located away from the previously treated lesion (i.e. distant brain failure) 12 months after SRS. Time to the appearance of new brain metastasis was defined as the time between SRS and distant brain failure. Patients without new distant brain metastases as of the last follow-up were censored at the last follow-up date. Kaplan-Meier methods were used to describe the time to distant brain failure.|12 month after SRS|The rate of distant brain metastases is a patient-specific outcome. Of the 49 patients enrolled, six had insufficient post-SRS imaging data to be included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2730072|NCT01017497|Secondary|Rate of Radionecrosis at SRS Treatment Site|The rate of radionecrosis is defined as the proportion of lesions with an indication of radiation-associated changes but no evidence of viable tumor on follow-up imaging (and confirmed by tissue biopsy whenever possible).|24 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.|||proportion of lesions|Participants|95% Confidence Interval|Number
2730073|NCT01017497|Primary|12-month Local Control Rate|The 12-month local control rate is the percentage of lesions without recurrence at the lesion site 12 months after SRS. Time to local recurrence was defined as the time between SRS and local recurrence. If local recurrence did not occur, the time to local recurrence was censored at last follow-up (including deaths without local recurrence). Kaplan-Meier methods were used to describe the time to local recurrence.|12 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.|||percentage of lesions|Participants|95% Confidence Interval|Number
2730074|NCT01017263|Primary|Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.|The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.|Baseline to end of study|Study terminated early - no analysis performed on the single subject with data.||||||
2730075|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-6) mm^2/s||Inter-Quartile Range|Median
2730076|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-6) mm^2/s||Inter-Quartile Range|Median
2730077|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-1)||Inter-Quartile Range|Median
2730078|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. By measuring extracellular extravascular volume fraction (EVF) it is possible to gain information on brain tissue perfusion. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-1)||Inter-Quartile Range|Median
2730079|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||mmol/kg∙s||Inter-Quartile Range|Median
2730080|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||mmol/kg∙s||Inter-Quartile Range|Median
2730081|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-2) min(-1)||Inter-Quartile Range|Median
2730082|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume, with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-2) min(-1)||Inter-Quartile Range|Median
2730083|NCT01017250|Secondary|Steroid Usage After Stereotactic Radiosurgery (SRS)|Number of patients using steroids at baseline and at 2 months after SRS.|2 months after SRS 2 months after SRS 2 months after SRS||||participants|||Number
2730084|NCT01017250|Secondary|Performance Status at 2 Months After Stereotactic Radiosurgery (SRS)|"Number of patients with a 10% decline in Karnofsky Performance Status (KPS) from baseline to 2 months after SRS. KPS is rated on a 0 to 100 scale representing a patient's ability to perform normal activity, ability to do active work, and the need for assistance. A score of 100 is perfect health and 0 represents death."|2 months after SRS|Intent to Treat: only 13 out of 15 patients completed month 2 KPS scores|||participants|||Number
2730085|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT). The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Shorter time scores indicates improved cognition. Change score = score at 2 months after SRS - score at baseline. Negative change scores indicate improved cognition.|2 months after SRS|Intent to treat: only 14 of 15 patients completed the month 2 questionnaire|||seconds||Standard Error|Mean
2730086|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline to 2 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score at 2 months after SRS - score at baseline. Higher scores for this scale indicate improved quality of life(QOL). Positive change scores indicate improved cognition.|2 months after SRS|Intent to Treat: only 14 patients out of 15 completed the month 2 questionnaire|||units on a scale||Standard Error|Mean
2730109|NCT01017237|Primary|Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.|Percentage of patients unable to recall picture|Day of Surgery prior to discharge|Per protocol|||percentage of patients|||Number
2755452|NCT00839241|Secondary|Interleukin-4||Day 5 postop||||pg/mL||Standard Deviation|Mean
2730087|NCT01017250|Secondary|Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)|Quality of life as measured by the change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) scores from baseline to 2 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Higher scores for all scales indicate improved quality of life (QOL).Change score = score at 2 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|2 months after SRS|Intent to Treat; only 10 patients out of 15 completed the month 2 questionnaire.|||units on a scale||Standard Error|Mean
2730088|NCT01017250|Secondary|Overall Survival(OS)|Time in months from the start of stereotactic radiosurgery (SRS) to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat|||months||95% Confidence Interval|Median
2730089|NCT01017250|Secondary|Radiographic Response at Month 2|Radiographic response at 2 months after stereotactic radiosurgery (SRS) assessed by MRI and based on modified Response Assessment in Neuro-Oncology (RANO) criteria.Per RANO, complete response (CR) is the disappearance of all target lesions;Partial Response(PR)is a >=30% decrease in the sum of the longest diameter of target lesions.|2 months after SRS|Intent to treat|||Participants|||Number
2730090|NCT01017250|Secondary|Progression-free Survival (PFS)|Time in months from the start of stereotactic radiosurgery (SRS) to the date of first progression according to Revised Assessment in Neuro-Oncology (RANO)criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Per RANO, progression is defined as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in a non-target lesion or the appearance of new lesions.|1 year|Intent to treat|||months||95% Confidence Interval|Median
2730091|NCT01017250|Primary|Central Nervous System (CNS) Toxicity|"Number of participants who experience Grade 3 or higher adverse events in the Nervous System Disorder domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0."|2 months after Stereotactic Radiosurgery|The number of participants with CNS toxicity is reported.|||participants|||Number
2730092|NCT01017237|Secondary|Bispectral Index Score (BIS)|Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.|During surgery duration.|per protocol|||units on a scale||Standard Deviation|Mean
2730093|NCT01017237|Secondary|Ramsey Sedation Scale Score|Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive|During surgical procedure|per protocol|||units on a scale||Standard Deviation|Mean
2730094|NCT01017237|Secondary|Patient Satisfaction With Sedation Technique|Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied|after completion of surgery (within 15 minutes)|per protocol|||units on a scale||Standard Deviation|Mean
2730095|NCT01017237|Secondary|Surgeon Satisfaction With Sedation Technique|Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)|After surgery completed: day of surgery, within 15 minutes|per protocol|||units on a scale||Standard Deviation|Mean
2730096|NCT01017237|Secondary|Heart Rate|Per EKG monitor|Duration of surgery|per protocol|||Beats per minute||Standard Deviation|Mean
2730097|NCT01017237|Secondary|Heart Rate|Heart rate per EKG monitor|Prior to sedation|per protocol|||Beats per minute||Standard Deviation|Mean
2730098|NCT01017237|Secondary|Mean Arterial Blood Pressure|Measured using automated blood pressure monitor|During duration of surgery|per protocol|||mmHg||Standard Deviation|Mean
2730099|NCT01017237|Secondary|Mean Arterial Blood Pressure|Blood pressure per automated monitor|Immediately prior to surgery|per protocol|||mmHg||Standard Deviation|Mean
2730100|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured by capnography at nares|Duration of surgery|per protocol|||mmHg||Standard Deviation|Mean
2730101|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured via capnography at nares|Immediately prior to sedation|per protocol|||mmHg||Standard Deviation|Mean
2730102|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|per protocol|||percentage of patients|||Number
2730103|NCT01017237|Primary|Amnesia: Lack of Picture Recall at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia|Day of surgery prior to discharge|per protocol|||percentage of patients|||Number
2730104|NCT01017237|Primary|Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|Per protocol|||percentage of patients|||Number
2730105|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery|Lack of recall of picture shown indicates presence of amnesia|Day of Surgery prior to discharge|per protocol|||percentage of patients|||Number
2730106|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.|Lack of recall of picture demonstrates presence of amnesia on day following surgery|One day after surgery|per protocol|||percentage of patients|||Number
2730107|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery|Lack of recall of picture shown at this time indicates presence of amnesia|Day of Surgery prior to discharge|per protocol|||percentage of patients|||Number
2730108|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.|Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.|One day after surgery|per protocol|||percentage of patients|||Number
2755453|NCT00839241|Secondary|Interleukin-4||Baseline||||pg/mL||Standard Deviation|Mean
2730115|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown Prior to Sedation.|Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery|Day of surgery prior to discharge|Randomized per protocol|||percentage of participants|||Number
2730116|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730117|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730118|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730119|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness: skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of drying reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730120|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study|||participants|||Number
2730121|NCT01017146|Secondary|Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants' skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-6=small effect on the participant's life; 7-12=moderate effect on the participant's life; 13-18=very large effect on the participant's life; 19-30=extremely large effect on the participant's life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.|||scores on a scale||Standard Deviation|Mean
2730122|NCT01017146|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants' skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-5=small effect on the participant's life; 6-10=moderate effect on the participant's life; 11-20=very large effect on the participant's life; 21-30=extremely large effect on the participant's life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.|||Scores on a scale||Standard Deviation|Mean
2730123|NCT01017146|Secondary|Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set|||participants|||Number
2730124|NCT01017146|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
2730125|NCT01017146|Secondary|Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set|||participants|||Number
2730126|NCT01017146|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.|||days||95% Confidence Interval|Median
2730127|NCT01017146|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.|||lesion counts||Standard Deviation|Mean
2730128|NCT01017146|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.|||percent change||Standard Deviation|Mean
2730129|NCT01017146|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
2730130|NCT01017146|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set|||participants|||Number
2730131|NCT01017146|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.|||lesion counts||Standard Deviation|Mean
2730132|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730133|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730134|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730157|NCT01017042|Primary|Maximum Plasma Concentration|The maximum or peak concentration that the drug reaches in the plasma.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).||||picograms/ml||Standard Deviation|Mean
2755454|NCT00839241|Secondary|Interleukin-2||Day 8 postop||||pg/mL||Standard Deviation|Mean
2730135|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
2730136|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study|||participants|||Number
2730137|NCT01017120|Secondary|Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants' skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-6=small effect on the participant's life; 7-12=moderate effect on the participant's life; 13-18=very large effect on the participant's life; 19-30=extremely large effect on the participant's life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Week 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.|||scores on a scale||Standard Deviation|Mean
2730138|NCT01017120|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants' skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-5=small effect on the participant's life; 6-10=moderate effect on the participant's life; 11-20=very large effect on the participant's life; 21-30=extremely large effect on the participant's life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.|||scores on a scale||Standard Deviation|Mean
2730139|NCT01017120|Secondary|Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12|A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||closed comedone count||Standard Deviation|Mean
2730140|NCT01017120|Secondary|Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12|An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||open comedone count||Standard Deviation|Mean
2730141|NCT01017120|Secondary|Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12|A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||nodule count||Standard Deviation|Mean
2730142|NCT01017120|Secondary|Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12|A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||pustule count||Standard Deviation|Mean
2730143|NCT01017120|Secondary|Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12|A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||papule count||Standard Deviation|Mean
2730144|NCT01017120|Secondary|Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||participants|||Number
2730145|NCT01017120|Secondary|Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set|||participants|||Number
2739101|NCT00957359|Secondary|QoL Physical Health Scale|4-20 (higher score improved quality of life domain)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2730146|NCT01017120|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
2730147|NCT01017120|Secondary|Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set|||participants|||Number
2730148|NCT01017120|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.|||days||95% Confidence Interval|Median
2730149|NCT01017120|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.|||lesion counts||Standard Deviation|Mean
2730150|NCT01017120|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.|||percentage change||Standard Deviation|Mean
2730151|NCT01017120|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
2730152|NCT01017120|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set|||participants|||Number
2730153|NCT01017120|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.|||lesion counts||Standard Deviation|Mean
2730154|NCT01017042|Primary|Area Under The Concentration Time Curve From Zero Through Infinity (AUC∞)|"The area under the plasma concentration versus time curve extrapolated to infinity.~AUC∞ is calculated as the sum of Total AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant"|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).||||pg-hr/ml||Standard Deviation|Mean
2730155|NCT01017042|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (96 Hours) (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration (96hours), calculated by the linear trapezoidal rule.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).||||pg-hr/ml||Standard Deviation|Mean
2730156|NCT01017042|Secondary|Electrocardiogram Corrected QT Interval (QTcF)|Corrected QT interval by Fridericia's formula -Measured at baseline, 0.5, 1, 2, and 4 hours|Measured at baseline, 0.5, 1, 2, and 4 hours|All participants|||Milliseconds||Standard Deviation|Mean
2739102|NCT00957359|Secondary|Demoralization Scale|0-96 (higher score more demoralized)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2730161|NCT01017029|Secondary|Hazard Cox's Model Analysis of Pericardial/Pleural Effusions|Pericardial effusions: any pericardial effusion defined as at least moderate (i.e. measuring at least 2.0 cm in diastole, in the point of largest distance between the pericardial leaflets), with or without signs of hemodynamic compromise, or leading to drainage or to prolonged hospitalization. Pleural effusions: need for surgical drainage tubes for longer than 7 days after surgery and subsequent pleural effusions leading to drainage. CI = confidence interval, HR = hazard ratio, MDRD = Modification of Diet in Renal Disease|6 months|safety population|||participants|||Number
2730162|NCT01017029|Secondary|Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group||6 months|safety population|||participants|Participants|95% Confidence Interval|Number
2730163|NCT01017029|Primary|Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group|Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm|6 months|safety population|||participants||95% Confidence Interval|Number
2730164|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|by protocol|||pg-h/ml||Standard Deviation|Mean
2730165|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.|0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing|by protocol|||pg-h/ml||Standard Deviation|Mean
2730166|NCT01017003|Primary|Maximum Serum Concentration (Cmax)|maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions|Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|per protocol|||pg/mL||Standard Deviation|Mean
2730167|NCT01016977|Secondary|Overall Satisfaction With Study Product at Week 12|"Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): What is your overall satisfaction with the study product. Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied."|Week 12|ITT Population|||units on a scale||Standard Deviation|Mean
2730168|NCT01016977|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
2730169|NCT01016977|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
2730170|NCT01016977|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
2730171|NCT01016977|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
2730223|NCT01016652|Secondary|Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper|Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects|Baseline|Analysis was on those subjects who were randomized to either treatment arm with the intent to treat.|||percentage of participants|||Number
2730172|NCT01016977|Secondary|Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12|The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population|||lesions||Standard Deviation|Mean
2730173|NCT01016977|Secondary|Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12|Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population|||lesions||Standard Deviation|Mean
2730174|NCT01016977|Secondary|Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12|The investigator conducted the overall assessment of the participant's facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe.|Baseline and Week 12|ITT Population|||participants|||Number
2730175|NCT01016977|Primary|Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2730176|NCT01016977|Primary|Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2730177|NCT01016977|Primary|Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2730178|NCT01016977|Primary|Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2730179|NCT01016977|Primary|Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2730180|NCT01016977|Primary|Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2730181|NCT01016977|Primary|Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
2731939|NCT01004393|Secondary|Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
2730182|NCT01016964|Primary|Change in Hair Count at 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks||||hairs per cm^2||Standard Deviation|Mean
2730183|NCT01016938|Secondary|Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation|The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.|2 years||||participants|||Number
2730184|NCT01016938|Primary|Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors|"Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm.~The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI."|2 years||||participants|||Number
2730185|NCT01016912|Secondary|Percentage of Participants With Virologic Failure|Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.|From on-treatment Week 1 to Follow-up Week 24|All participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
2730186|NCT01016912|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24|SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .|Follow-up Weeks 4, 12, and 24|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2730187|NCT01016912|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory|At Week 12 on treatment|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2730188|NCT01016912|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .|At Week 4 on treatment|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2730189|NCT01016912|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.|At Weeks 4 and 12 on treatment|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
2730190|NCT01016912|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.|||participants|||Number
2730191|NCT01016912|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.|||participants|||Number
2730192|NCT01016873|Secondary|Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52||Week 52||||CNV as % of Lesion||Standard Deviation|Mean
2730193|NCT01016873|Secondary|Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.||Week 12, 28, and 104||||Number of Injections||Standard Deviation|Mean
2730194|NCT01016873|Secondary|Time From Mandatory Injection at Day 0 to the First PRN Injection.||52 Weeks||||Weeks||95% Confidence Interval|Median
2730195|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"|||Percentage of Patients|||Number
2730196|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"|||Proportion of Patients|||Number
2730197|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"|||Percentage of Patients|||Number
2730201|NCT01016847|Secondary|Asthma Exacerbation|Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.|Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
2730202|NCT01016847|Secondary|Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
2730203|NCT01016847|Secondary|Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
2730204|NCT01016847|Secondary|Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
2730205|NCT01016847|Primary|Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
2730206|NCT01016834|Secondary|Treatment Confidence|Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.|After 4 migraines or 60 days||||participants|||Number
2730207|NCT01016834|Secondary|Treatment Preference|Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).|After 4 migraines or 60 days||||participants|||Number
2730208|NCT01016834|Primary|Overall Satisfaction|"Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c Overall satisfaction was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)"|After 4 migraines or 60 days|The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.|||Scale of 0-100; 100= very satisfied||Standard Deviation|Mean
2730209|NCT01016769|Secondary|Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition||2 years||||Participants|||Count of Participants
2730210|NCT01016769|Secondary|Median Overall Survival||2 years|The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 7 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis.|||months||95% Confidence Interval|Median
2730211|NCT01016769|Secondary|Number of Participants Who Experienced Adverse Events|Safety will be assessed in terms of AEs according to CTCAE version 3.0|2 years||||Participants|||Count of Participants
2730212|NCT01016769|Primary|To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC|"Evaluation of target lesions:~Complete Response - disappearance of all target lesions Partial Response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Progressive Disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one of more new lesions Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started"|6 weeks|The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 6 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis.|||Participants|||Count of Participants
2730213|NCT01016769|Primary|Phase II Recommended Dose for the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin.||2 years|The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 6 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis.|||mg|||Number
2730214|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 5||Day 4 to Day 5|||||||
2730215|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 4||Baseline to Day 4|||||||
2730216|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 3||Baseline to Day 3|||||||
2730217|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 2||Baseline to Day 2|||||||
2730218|NCT01016691|Primary|Mean Change in Intraocular Pressure at Day 1||Baseline to Day 1|per-protocol population|||mmHg||Standard Deviation|Mean
2730219|NCT01016678|Secondary|To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.|Collected from patient reported paper diaries|3 years|This analysis data was not collected.||||||
2730220|NCT01016678|Primary|Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention|All data was collected and measured from self-reported patient diaries|3 years|94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks|||percentage of attacks|Participants||Number
2730221|NCT01016678|Primary|Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose|All data was collected and measured from self-reported patient diaries|3 years|Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours|||percentage of attacks|Participants||Number
2730222|NCT01016678|Primary|Number of Participants With 2-hour Pain Free Active Study Drug|All data was collected and measured from self-reported patient diaries|3 years|The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis|||Participants|||Number
2755455|NCT00839241|Secondary|Interleukin-2||Day 5 postop||||pg/mL||Standard Deviation|Mean
2730224|NCT01016652|Secondary|Comfortable Wearing Time|Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.|week 4|Analysis was on those subjects randomized to either arm with the intent to treat.|||hours||Inter-Quartile Range|Median
2730225|NCT01016652|Secondary|Subject Reported Lens Comfort Using CLUE Questionnaire|Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.|week 4|Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat.|||units on a scale||Inter-Quartile Range|Median
2730226|NCT01016652|Secondary|Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ|Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).|week 4|The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm.|||percentage of participants|||Number
2730227|NCT01016652|Primary|Monocular Amplitude of Accommodation|The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.|week 4|Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen.|||diopters||Inter-Quartile Range|Median
2730228|NCT01016652|Primary|Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire|The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.|week 4|Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study.|||units on a scale||Inter-Quartile Range|Median
2730229|NCT01016600|Primary|Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age|"Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment.~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul."|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|Participants in Cohort 1, 2, and 3 were not analyzed for this outcome as it is a Phase II outcome measure only. (3) participants in Phase II cohort were not evaluable for response because they did not complete cycle 1.|||percentage of participants|||Number
2730230|NCT01016600|Secondary|Toxicity Profile (Grade 3/4 Toxicities)|AML ≥18 years or untreated AML ≥60 years|30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))||||participants|||Number
2730231|NCT01016600|Secondary|Duration of CR for Complete Responders||Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(6) participants in Cohort 1, (3) participants in Cohort 2, (4) participants in Cohort 3, and (10) participants in Phase II did not have a complete response and are not evaluable for this outcome.|||months||Full Range|Median
2730232|NCT01016600|Secondary|Relapse Free Survival (RFS)|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))||||months||Full Range|Median
2730233|NCT01016600|Secondary|Time to Progression (TTP)|Defined as the interval from the date of the first dose of study drug to the date of progressive disease.|Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))|(2) cohort 1 participants were not evaluable for this outcome measure because (1) was removed for DLT & (1) withdrew from study. (2) phase II participants were not evaluable because both were removed from study in the first cycle for adverse events.|||months||Full Range|Median
2730234|NCT01016600|Secondary|Event Free Survival|Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))||||months||Full Range|Median
2730235|NCT01016600|Secondary|Overall Survival|Defined as the date of first dose of study drug to the date of death from any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))||||months||Full Range|Median
2730236|NCT01016600|Secondary|Partial Remission Rate (PR)|Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
2730237|NCT01016600|Secondary|CR With Incomplete Blood Counts Rate|Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
2730238|NCT01016600|Secondary|Cytogenetic CR (CRc) Rate|Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
2730239|NCT01016600|Secondary|Morphologic Complete Remission Rate (CRm)|Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
2730240|NCT01016600|Secondary|Morphologic Leukemia-free State|Defined as < 5% blasts on the BM aspirate with spicules and a count of >200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
2730241|NCT01016600|Secondary|Response Rate (CRm + CRc + CRi + PR)|"Response rate (CRm + CRc + CRi + PR)~CRm = morphologic complete remission~CRc = cytogenetic complete remission~CRi = morphologic complete remission with incomplete blood count recovery~PR = partial remission"|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response. (1) participant in Cohort one had both CRm and CRc.|||participants|||Number
2730242|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.~Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.~Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)||||mg/m^2|||Number
2730243|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.~Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.~Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)|(1) participant in Cohort 1 did not start treatment. The Phase II cohort was not analyzed because this was a Phase I outcome only.|||dose-limiting toxicities|||Number
2730244|NCT01016483|Secondary|Phase II: Volume of Central Compartment (V1/f) and Volume of Peripheral Compartment (V2/f) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.||||||
2730245|NCT01016483|Secondary|Phase II: Clearance From Central Compartment (CL/f) and Intercompartmental Clearance (Q/f) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.||||||
2730246|NCT01016483|Secondary|Phase II: Absorption Rate Constant (ka) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.||||||
2730247|NCT01016483|Secondary|Phase II: Overall Survival (OS) Time|Overall survival (OS) time is defined as the time (in months) from randomization to death.|Baseline, every 8 weeks up to EOT (6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||months||95% Confidence Interval|Median
2730248|NCT01016483|Secondary|Phase II: Time to Progression (TTP)|Time to progression (TTP) is defined as the time (in months) from the randomization date to the date of progression prior to the start of any subsequent therapy for the primary disease, as reported and documented by the Investigator (i.e. radiological progression per RECIST).|From randomization every 8 weeks up to EOT (6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||months||95% Confidence Interval|Median
2730249|NCT01016483|Secondary|Phase II: Percentage of Subjects With Clinical Benefit|Clinical Benefit was defined as the presence of at least one CR, PR or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||percentage of subjects|||Number
2730299|NCT01015703|Primary|Safety Events|Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.|Duration of study||||percentage of patients|||Number
2739103|NCT00957359|Secondary|Demoralization Scale|0-96 (higher score more demoralized)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2730250|NCT01016483|Secondary|Phase II: Percentage of Subjects With Best Overall Response (BOR)|Best overall response was defined as the presence of at least one complete response (CR), partial response (PR) or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||percentage of subjects|||Number
2730251|NCT01016483|Secondary|Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.|From the first dose of study drug administration until EOT (6 years)|SAF for the Phase II included all subjects who had received at least 1 administration of the trial medication Gemcitabine or Placebo if the subject is in the gemcitabine + Placebo treatment arm (Arm 1) and MSC1936369B or gemcitabine in the MSC1936369B + gemcitabine treatment arm (Arm 2).|||subjects|||Number
2730252|NCT01016483|Secondary|Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2|ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.|pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1|"Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here n signifies those subjects who were evaluable at the specified time point for each arm respectively."|||Fluorescence Intensity||Standard Deviation|Mean
2730253|NCT01016483|Secondary|Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e. gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
2730254|NCT01016483|Secondary|Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
2730255|NCT01016483|Secondary|Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2730256|NCT01016483|Secondary|Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||Liter per hour (L/H)||Geometric Coefficient of Variation|Geometric Mean
2730257|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
2730258|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1.Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
2739104|NCT00957359|Secondary|Demoralization Scale|0-96 (higher score more demoralized)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2730259|NCT01016483|Secondary|Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2|AUC:0 to infinity is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2730260|NCT01016483|Secondary|Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2730261|NCT01016483|Secondary|Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1|ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.|pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1|"Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here n signifies those subjects who were evaluable at the specified time point for each arm, respectively."|||Fluorescence Intensity||Standard Deviation|Mean
2730262|NCT01016483|Secondary|Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
2730263|NCT01016483|Secondary|Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
2730264|NCT01016483|Secondary|Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|"PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here n signifies those subjects who were evaluable at the specified time point."|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2730265|NCT01016483|Secondary|Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2730266|NCT01016483|Secondary|Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1|AUC:0 to infinity was a measure of the serum concentration of the drug over time. It was used to characterize drug absorption.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2730267|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1|Plasma decay half-life was the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
2730356|NCT01015170|Primary|7-day Point Prevalence of Smoking Abstinence|"Number of participants who report Not Smoking (not even a puff) in past 7 days when asked at week 8"|End of Treatment (8 weeks after Zyban start date)|Participants who completed survey 8 weeks after Zyban start date|||participants|||Number
2730268|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
2730269|NCT01016483|Secondary|Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|Pharmacokinetic set (PKS) of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2730270|NCT01016483|Secondary|Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.|From the first dose of study drug administration until EOT (6 years)|Safety analysis set (SAF) for the safety run-in part included all subjects who had received at least 1 administration of the trial medication (pimasertib or gemcitabine).|||subjects|||Number
2730271|NCT01016483|Primary|Phase II: Progression-Free Survival (PFS) Time|PFS was defined as the time from randomization to the first documentation of objective tumor progression (Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline, Progressive Disease (PD): At least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started) or to death due to any cause, whichever occurred first. PFS calculated as (Months) = Date of first PD or death or censoring date minus date of randomization plus 1) divided by 30.4375.|From the time of randomization to every 8 weeks up to end of treatment (EOT) (6 years)|Intent to Treat (ITT) analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||months||95% Confidence Interval|Median
2730272|NCT01016483|Primary|Safety Run-In Part: Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia > 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay > 2 weeks due to drug-related adverse effects.|Up to 28 days in Cycle 1|DLT analysis set included all subjects of safety run-in part who received any dose of pimasertib on at least 18 out of 20/25 out of 28 of the planned days on pimasertib & least 3 gemcitabine weekly infusions during first 28 days of treatment or experienced DLT during the 28 first days of treatment regardless of the amount of each drug received.|||subjects|||Number
2730273|NCT01016353|Primary|Number of Participants With Primary Fascial Closure||Up to 30 days||||Participants|||Count of Participants
2730274|NCT01016262|Secondary|Time to Relief of Tenesmus|Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.|Day 1 up to Week 6|ITT population included all randomized participants.|||days||95% Confidence Interval|Median
2730275|NCT01016262|Secondary|Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6|The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.|Baseline, Week 6|The ITT population included all the participants randomized to study treatment. Missing values were imputed using remaining item average (RIA) imputation algorithm. Here 'n' signifies those participants who were evaluable at specific time point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2730276|NCT01016262|Secondary|Time to Relief of Rectal Bleeding|Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.|Day 1 up to Week 6|ITT population included all randomized participants.|||days||95% Confidence Interval|Median
2730386|NCT01014988|Secondary|Number of Participants With the Indicated Mortality Status at Day 14 and Day 28|The number of participants who died on or before Study Day 14 and Study Day 28 was summarized. Only those participants available at the specified time points were analyzed.|Day 14 and Day 28|ITT-E Population|||Participants|||Number
2730277|NCT01016262|Secondary|Percentage of Participants Who Were Responders at Week 3|Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).|Week 3|ITT population included all randomized participants. Missing values were imputed using NR imputation method.|||percentage of participants|||Number
2730278|NCT01016262|Primary|Percentage of Participants Who Were Responders at Week 6|Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).|Week 6|ITT population included all randomized participants. Missing values were imputed using non-responder (NR) imputation method.|||percentage of participants|||Number
2730279|NCT01016132|Primary|Overall Preference|"Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses."|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Participants|||Number
2730280|NCT01016106|Primary|Heterozygous for Filaggrin (FLG) Null Mutations|Buccal swab samples were obtained from each subject. Deoxyribonucleic acid (DNA) was purified from buccal swabs (IsoHelix Swabs, BocaScientific, Boca Raton, FL) and quantified by ultraviolet spectrophotometry. Purified genomic DNA and controls were amplified by polymerase chain reaction (PCR) from three different regions of FLG exon 3 with three primer sets. PCR products were analyzed by electrophoresis, purified (Qiaquick, Qiagen, Valencia, CA), and subjected to duplicate cycle sequencing reactions using ABI BigDye v3.1 reagents (Applied Biosystems, Carlsbad, CA). Labeled sequencing products were purified for capillary electrophoresis (ABI3730 or ABI3130 sequencer with POP7 polymer), and sequence results were examined using ABI SeqScape software. All nucleotide changes were noted, including 30 single nucleotide polymorphism (SNPs) in the population tested, the most common of which were coding changes at T454A, H2507Q, and G2545R, and silent change at nucleotide t2508c.|1 month||||participants|||Number
2730281|NCT01016067|Secondary|"Number of Subjects Having Additional Surgical Procedure Classified as a Treatment Failure"|"Subject who had a surgery after the original study treatment was classified as a treatment failure if the additional surgery or treatment occurred in the involved limb and affected the study treatment and/or its mechanism of action in relation to the diagnosis or condition of the subject that was the cause for having the original study treatment."|12 months||||participants|||Number
2730282|NCT01016067|Secondary|Success in Short Form 36-Item (SF-36) Health Survey|SF-36 was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success was defined as any improvement in a subject's SF-36 PCS post-operatively as compared to the pre-operative condition.|12 months||||participants|||Number
2730283|NCT01016067|Secondary|Success in Short Musculoskeletal Functional Assessment (SMFA)|The SMFA is an assessment tool that measures a subject's overall function for a broad range of musculoskeletal injuries and disorders. The SMFA results were summarized into two components, the dysfunctional index and the bother index. Success for the SMFA assessment was defined as any improvement post-operatively as compared to the pre-operative condition.|12 months||||participants|||Number
2730284|NCT01016067|Secondary|Success of Pain Status at the Delayed Healing Site|"After walking five or six steps, subjects rated their intensity of pain/discomfort at the delayed healing site using a numerical rating scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Subjects who were unable or declined to walk because of severe leg pain were considered to have a score of 10. Success for pain at the delayed healing site was defined as at least a 2-point improvement in pain from the pre-operative score. Success of pain status at the delayed healing site was a component of overall success."|12 months||||participants|||Number
2730285|NCT01016067|Secondary|Success in Weight Bearing Ability|Success in weight bearing ability (a component of overall success) was defined that subject was able to bear weight without severe pain on the affected limb. The subject was asked to stand, bearing full weight on the affected limb in a single-leg stance without ambulatory assistance for 10 seconds. If the subject was able to do so without severe pain, a positive (success) response was recorded. If the subject was either unable to stand on the affected limb in a single-leg stance or declined to do so because of limb weakness, poor balance, or severe leg pain, a negative (failure) response was documented.|12 months||||participants|||Number
2730286|NCT01016067|Secondary|Radiographic Union Success|Radiographic union success (a component of overall success) was defined as complete disappearance of fracture lines or the presence of bridging bone across the delayed healing site as observed on at least three of the four cortices (anterior, posterior, medial, and lateral), using plain films. If there was more than one delayed healing fracture line, all fracture lines must have been united in order to be considered a successful fracture union.|12 months||||participants|||Number
2730287|NCT01016067|Primary|Overall Success|"Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as implant-associated or implant/surgical procedure-associated (device-related); 5.no additional surgical procedures classified as a failure."|12 Months|"Ten investigational and 9 control subjects were evaluable for overall success while only 9 investigational and 8 control subjects completed the study at 12-month follow-up. Two subjects were classified as failure due to related serious adverse event or additional surgery before completion of the study."|||participants|||Number
2732021|NCT01003639|Secondary|Visual Function Questionnaire (VFQ-25)|Visual Function Questionnaire (VFQ-25) total score, VFQ-25 10-item neuro-ophthalmic supplement total score: 0-100 (higher scores indicate better quality of life)|baseline||||units on a scale||Standard Deviation|Mean
2730288|NCT01016015|Primary|Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks||||participants|||Number
2730289|NCT01015976|Primary|AUC Post Surgery (n =5) Compared to AUC Control (n=5)|AUC of surgery group compared to the AUC of control group|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours|Per protocol|||ng-hr/mL||Standard Deviation|Mean
2730290|NCT01015833|Secondary|Best Overall Response Rate|Best Overall Response Rate is defined as is the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|Up to 3 years|Patients who started treatment and had follow-up assessments were included in this analysis.|||percentage of patients|||Number
2730291|NCT01015833|Secondary|Time to Progression (TTP)|Time to Progression (TTP) is defined as the time from on study to progression. Progression is defined by the RECIST criteria as Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Median and 95% confidence intervals are provided for each arm below.|Up to 3 years||||months||95% Confidence Interval|Median
2730292|NCT01015833|Secondary|Progression Free Survival|Progression free survival is defined as the time from study entry to earliest date of disease progression. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression).|Up to 3 years||||months||95% Confidence Interval|Median
2730293|NCT01015833|Secondary|Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 3 years||||percentage of patients|||Number
2730294|NCT01015833|Primary|Overall Survival|Overall survival is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|Up to 3 years||||month||95% Confidence Interval|Median
2730295|NCT01015820|Primary|Mean Blood Vessel Radius (BVR)|BVR serves as a marker for early increase of blood supply (EIBS).|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.|||cm||95% Confidence Interval|Mean
2730296|NCT01015820|Primary|Deoxyhemoglobin Concentration (DHb)|Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.|||alpha units||95% Confidence Interval|Mean
2730297|NCT01015807|Primary|Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups|Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.|48hrs after CS||||cm^2||Inter-Quartile Range|Mean
2730298|NCT01015781|Primary|Tinnitus Functional Index Change Score|"The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for responsiveness (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change.~Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores:~<25 = relatively mild tinnitus (little or no need for intervention)~25-50 = significant problems with tinnitus (possible need for intervention) •>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful."|Baseline, 6 months (from Baseline)|"The analysis was intention to treat (ITT). Includes all subjects from whom both baseline and 6 month data were collected."|||units on a scale||Standard Deviation|Mean
2732080|NCT01002742|Secondary|Overall GVHD-free Survival Post-randomization||Months 6 and 12||||percentage of participants||95% Confidence Interval|Number
2730300|NCT01015677|Secondary|Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4|FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint).|Baseline and Week 4|The Per-Protocol (PP) population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.|||mIU/mL||90% Confidence Interval|Least Squares Mean
2730301|NCT01015677|Secondary|Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4|Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.|||Percent change||95% Confidence Interval|Least Squares Mean
2730302|NCT01015677|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The APaT population is all participants who received at least one dose of study drug.|||Participants|||Number
2730303|NCT01015677|Primary|Number of Participants Who Experienced at Least One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 6 weeks|The All-Patients-as Treated (APaT) population is all participants who received at least one dose of study drug.|||Participants|||Number
2730304|NCT01015677|Primary|Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4|Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.|||Percent change||95% Confidence Interval|Least Squares Mean
2730305|NCT01015638|Secondary|Subject Assessment - Oiliness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
2730306|NCT01015638|Secondary|Subject Assessment - Blistering|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
2730307|NCT01015638|Secondary|Subject Assessment - Crusting|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
2730308|NCT01015638|Secondary|Subject Assessment - Pain|"At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.~Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
2730309|NCT01015638|Secondary|Subject Assessment - Roughness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here."|2 weeks||||units on a scale||Standard Deviation|Mean
2730387|NCT01014988|Secondary|Median Time to Return to Pre-morbid Functional Status|Time to return to pre-morbid functional status was assessed on a 3-point scale (bed rest, limited ambulation, or unrestricted). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Days||Full Range|Median
2732081|NCT01002742|Secondary|Incidence of Topical/Non-absorbable Therapy||Day 56||||participants|||Number
2730310|NCT01015638|Secondary|Subject Assessment - Dryness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here."|2 weeks||||units on a scale||Standard Deviation|Mean
2730311|NCT01015638|Secondary|Subject Tolerability - Stinging|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here."|2 weeks||||units on a scale||Standard Deviation|Mean
2730312|NCT01015638|Secondary|Subject Tolerability - Burning|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here."|2 weeks|ITT|||units on a scale||Standard Deviation|Mean
2730313|NCT01015638|Secondary|Changes in the Skin Surface Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|14 days|ITT|||microsiemens||Standard Deviation|Mean
2730314|NCT01015638|Primary|Skin Dryness|"Visual Dryness was evaluated using the following scale:~Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring"|14 days|ITT|||units on a scale||Standard Deviation|Mean
2730315|NCT01015638|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration."|14 days||||grams/m^2/hour||Standard Deviation|Mean
2730316|NCT01015638|Primary|Erythema (Redness)|"Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.~Erythema (redness) was evaluated using the following scale:~Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion"|14 days|ITT|||units on a scale||Standard Deviation|Mean
2730317|NCT01015612|Secondary|Re-intervention|Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.|30 days||||probability of events at 30 days|||Number
2730318|NCT01015612|Secondary|Stroke|Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.|30 days||||probability of events at 30 days|||Number
2730319|NCT01015612|Secondary|Myocardial Infarction|Included Q-wave and non-Q-wave.|30 days||||probability of events at 30 days|||Number
2730320|NCT01015612|Secondary|All-Cause Mortality|is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.|30 days||||probability of events at 30 days|||Number
2730321|NCT01015612|Primary|Cardiac-related Death|Defined as all death resulting from a cardiac cause or complications of a cardiac procedure and / or death of an unknown cause; this category includes valve-related deaths and non-valve-related cardiac deaths (e.g. congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).|30 days||||probability of events at 30 days|||Number
2730322|NCT01015612|Primary|Percentage of Participants With Overall Device Success|"Vascular access, delivery and deployment of the device, and retrieval of the delivery system~Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)~Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg, without moderate or severe prosthetic valve aortic regurgitation)~Only one valve implanted~No occurrence of in-hospital MACCE"|24-48 hours after the procedure or before the discharge||||% of participants with device success|||Number
2730323|NCT01015612|Primary|Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate|Defined as a composite of all cause death, myocardial infarction(MI) (Q-wave & non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)|30 days||||probability of events at 30 days|||Number
2730324|NCT01015586|Secondary|Neurocognitive Performance (California Verbal Learning Test)|Adjusted scale scores (T scores) on the California Verbal Learning Test (CVLT) of verbal working memory at study endpoint. CVLT Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (mean = 50; SD=10) with higher scores indicating better performance.|Study endpoint 12 weeks after randomization|Sample analyzed includes study completers only (total n=25) as this measure was obtained at study endpoint.|||T scores||Standard Deviation|Mean
2730388|NCT01014988|Secondary|Duration of Mechanical Ventilation and Supplemental Oxygen Use|Due to the conditional nature of data collection post treatment, the duration of mechanical ventilation and supplemental oxygen use were not determined.|Up to discharge from the hospital|ITT-E Population||||||
2755456|NCT00839241|Secondary|Interleukin-2||Baseline||||pg/mL||Standard Deviation|Mean
2730325|NCT01015586|Secondary|Young Mania Rating Scale (YMRS) Scores|Mania/hypomania symptoms at study endpoint as assessed by the Young Mania Rating Scale (YMRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of eleven (11) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes.|Baseline and 12 weeks|Baseline YMRS scores include all randomized subjects (total n=43). Study endpoint YMRS scores include study completers only (total n=25).|||score on a scale||Standard Deviation|Mean
2730326|NCT01015586|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Score|Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of ten (10) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes.|Baseline and 12 weeks|All randomized subjects (total n=43) included in analysis at baseline. Study completers only (total n=25) included in analysis at study endpoint.|||units on a scale||Standard Deviation|Mean
2730327|NCT01015586|Secondary|Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT)|Serum levels of biomarkers of alcohol use: Gamma-glutamyltransferase (GGT) at study endpoint in study completers|12 weeks after randomization|Sample in this analysis is limited to study completers only (total n=25) because this measure was obtained at study endpoint.|||Units per liter (U/L)||Standard Deviation|Mean
2730328|NCT01015586|Secondary|Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT)|Serum levels of biomarkers of alcohol use: carbohydrate-deficient transferrin (CDT) at study endpoint in study completers|12 weeks after randomization|The sample analyzed is limited to study completers (total n=25) due to this measure being obtained at study endpoint.|||"percent CDT"||Standard Deviation|Mean
2730329|NCT01015586|Secondary|Percent Heavy Drinking Days|Percentage of days in trial that were heavy drinking days (5 or more drinks/day for men, 4 or more drinks/day for women); minimum = 0, maximum = 100; lower numbers indicate better outcome. Percent heavy drinking days was calculated as: (number of days of heavy drinking per self-report / total number of days in trial)*100.|12 weeks|Analysis is of modified intention to treat (mITT) sample comprised of all randomized subjects who returned for at least one study visit after randomization (total mITT sample n=37).|||Percentage of heavy drinking days||Standard Deviation|Mean
2730330|NCT01015586|Primary|Percent Days Abstinent From Alcohol|Percentage of days in trial without consumption of alcoholic beverages per participant self-report; minimum = 0, maximum = 100; higher numbers indicate better outcome. Percent days abstinent was calculated as: (number of days abstinent per self-report / total number of days in trial)*100.|12 weeks|Analysis is of modified intention to treat (ITT) sample comprised of all randomized subjects who returned for at least one study visit after randomization.|||Percentage of days abstinent||Standard Deviation|Mean
2730331|NCT01015560|Primary|uNTX Response Rate at 43 Days|Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.|43 days|Eligible and analyzable patients|||percentage of participants||95% Confidence Interval|Number
2730332|NCT01015534|Secondary|Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.|"AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0~Grade 3 Severe AE.~Grade 4 Life-threatening or disabling AE."|4 months|Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity .|||Events|||Number
2730333|NCT01015534|Secondary|Overall Survival|Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.|1 year|Data on all enrolled participants were included in an intention-to-treat analysis.|||Months of Overall Survival||95% Confidence Interval|Median
2730334|NCT01015534|Secondary|Survival Free of Brain Metastases Progression (PFS of BM)|Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.|at 90 days|Data on all enrolled participants were included in an intention-to-treat analysis.|||Percentage of Participants||95% Confidence Interval|Number
2730335|NCT01015534|Primary|Objective Response Rates. Assessed With Cranial MRI|"Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.~Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants."|90 days|Data on all enrolled participants were included in an intention-to-treat analysis.|||Percentage of participants with OR||95% Confidence Interval|Number
2730336|NCT01015443|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.|From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years|Safety analysis set included all subjects who received at least one dose of trial treatment.|||Subjects|||Number
2730474|NCT01014767|Primary|Time to Disease Progression|PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available|Till disease progression or death (up to 6 cycles of 28-day treatment)|PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available||||||
2730337|NCT01015443|Secondary|Time to Treatment Failure (TTF)|TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.|From the date of randomization to the date of first missed treatment, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
2730338|NCT01015443|Secondary|Progression Free Survival (PFS)|Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.|From the date of randomization to PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
2730339|NCT01015443|Secondary|Time to Progression (TTP)|Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.|From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
2730340|NCT01015443|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.|From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
2730341|NCT01015443|Primary|Overall Survival (OS) Time|OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.|From the date of randomization until death, assessed up to 5.6 years|The modified intent-to-treat (mITT) analysis set was based on the intention-to-treat (ITT) analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
2730342|NCT01015326|Primary|Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)|"Patients were asked How important is this symptoms or concern to your quality of life? They were given a series of items (listed in the table) and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. Experts were asked How important is this symptom or concern to patients' quality of life? They were given the same series of items and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. For each item, a mean score was calculated using the values assigned to that item from all patients, and a second mean score was calculated using the values assigned to that item from all experts. An item's mean score may range from 0 to 3, where 0 is equivalent to not at all important to quality of life and where 3 is equivalent to extremely important to quality of life."|at time of questionnaire|Additional items that were variably collected and recorded have been omitted from the data set.|||units on a scale||Standard Deviation|Mean
2730343|NCT01015287|Other Pre-specified|Summary of All-Cause Death|All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.|Randomization through 30 days|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2730475|NCT01014741|Secondary|Radiofrequency Ablation Time||at time of the procedure||||minutes||Standard Deviation|Mean
2730476|NCT01014741|Secondary|AF Termination|AF termination with complex fractionated atrial electrograms (CFAE) ablation|at time of the procedure||||participants|||Number
2730344|NCT01015287|Secondary|Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730345|NCT01015287|Secondary|Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)|Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.|Baseline, before PCI (not greater than 48 hours after randomization)|All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).|||ratio of assayed troponin/ULN||Standard Error|Least Squares Mean
2730346|NCT01015287|Secondary|Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730347|NCT01015287|Secondary|Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)|ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730348|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730349|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730350|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730351|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730352|NCT01015287|Secondary|Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730353|NCT01015287|Primary|The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout|The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2730354|NCT01015170|Secondary|7-day Point Prevalence of Smoking Abstinence|"Number of participants who report Not Smoking (not even a puff) in past 7 days when asked 6 months after Zyban start date"|6 months after Zyban start date|Number of participants who completed 6 month post treatment survey|||Participants|||Count of Participants
2730355|NCT01015170|Secondary|Serious Quit Attempt (at Least 24 Hours of Abstinence)|Number of participants who report a serious quit attempt at End of treatment|End of Treatment (8 weeks after Zyban start date)|This secondary outcome was not collected at 8 week followup.||||||
2755457|NCT00839241|Secondary|Interferon Gamma||Day 8 postop||||pg/mL||Standard Deviation|Mean
2730357|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmean measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
2730358|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmax measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
2730359|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmax determined at the end of Cycle 1 of chemotherapy.|||Correlation coefficient||90% Confidence Interval|Number
2730360|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmean determined at the end of Cycle 1 of chemotherapy.|||Correlation coefficient||90% Confidence Interval|Number
2730361|NCT01015131|Primary|Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI).|Baseline and up to 3 weeks|Participants whose Ki-67 Labeling Index were measured at Baseline and after 1 cycle of chemotherapy|||Labeling Index||Standard Deviation|Mean
2730362|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy|||SUV||Standard Deviation|Mean
2730363|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their Ki-67 LI measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
2730364|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their PSS measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
2730365|NCT01015131|Secondary|Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|MRI of participants was used to measure tumor volumes at baseline and after completing chemotherapy, after approximately 11 to 30 weeks of treatment.|Baseline and up to 30 weeks|Participants who had tumors measured by MRI at Baseline and at the end of chemotherapy|||cm^3||Standard Deviation|Mean
2730366|NCT01015131|Secondary|Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNBs) obtained at baseline and after approximately 2-3 weeks of treatment, at the end of the first cycle of chemotherapy, are used to measure cell proliferation by a Proliferation Signature Score (PSS). PSS is calculated from the messenger RNA (mRNA) expression of 47 genes that negatively correlate with time to recurrence, and involves taking their average normalized scores. For reference, a database of 16,000 tumors gave a minimum PSS of 1.51 and a maximum PSS of 2.89; where a higher PSS is associated with an increase in proliferation, higher tumor grade and worse outcomes.|Baseline and up to 3 weeks|Participants who had PSS determined at Baseline and after 1 cycle of chemotherapy|||Proliferation Score||Standard Deviation|Mean
2730367|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy|||SUV||Standard Deviation|Mean
2730477|NCT01014741|Secondary|Procedure Time|Overall procedure duration|at time of the procedure||||minutes||Standard Deviation|Mean
2730368|NCT01015118|Secondary|Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.|"Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.~As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).~Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with global health status/QoL|||units on a scale||Standard Error|Mean
2730369|NCT01015118|Secondary|Change in Abdominal/Gastro-intestinal Symptoms Over Time|"Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).~As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).~Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms|||units on a scale||Standard Error|Mean
2730370|NCT01015118|Secondary|Objective Response Based on Investigator Assessment|Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with at least 1 target lesion reported at baseline|||percentage of participants|||Number
2730371|NCT01015118|Secondary|Time to CA-125 Tumour Marker Progression|Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > Upper limit of normal (ULN) or CA-125 >=2 x ULN in case nadir value <= ULN.|First drug administration until final DBL 26September16, upto 62 months|Randomised set (RS)|||Months||Inter-Quartile Range|Median
2730372|NCT01015118|Secondary|Overall Survival|"Overall survival is defined as time from randomization to date of death (irrespective of reason).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of death until final DBL 26September16, upto 62 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
2730373|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).|Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.|First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
2730374|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).|"Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.~The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first , upto 29 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
2730375|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).|"Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
2730376|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.|"Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.~The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first , upto 29 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
2730377|NCT01014988|Secondary|Geometric Mean Volume of Distribution (Vd) of Zanamivir|"The Vd of zanamivir was evaluated. Volume of distribution is defined as the apparent volume in which zanamivir is distributed. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >= 80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2739105|NCT00957359|Secondary|Hopelessness|0-16 (higher score more hopeless)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2730378|NCT01014988|Secondary|Geometric Mean Serum Clearance of Zanamivir|"The serum clearance of zanamivir was evaluated. Clearance is defined as the volume of zanamivir per unit time eliminated from serum. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||mL per minutes||Geometric Coefficient of Variation|Geometric Mean
2730379|NCT01014988|Secondary|Geometric Mean Terminal Half Life (t1/2) of Zanamivir|"The t1/2 of zanamivir was evaluated. Terminal half life is defined as the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Day 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr>=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2730380|NCT01014988|Secondary|Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir|"The AUC(0-tau) during the repeat dose interval and AUC(0-inf) for the initial dose were evaluated. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||Micrograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2730381|NCT01014988|Secondary|Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion|"The Cmax of zanamivir was evaluated at the end of infusion. Serial blood samples for pharmacokinetic (PK) analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants who were neither on extracorporeal membrane oxygenation (ECMO) nor on continuous renal replacement therapy (CRRT), who were with CLcr >=80 mL/minutes (>=80mL/minute/1.73m^2 for cohorts 1-4) and who received an initial dose (ID) and a maintenance dose (MD) of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population: participants with one or more estimated zanamivir PK parameters|||Micrograms per mL||Geometric Coefficient of Variation|Geometric Mean
2730382|NCT01014988|Secondary|Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays|The duration of hospitalization (H) reflects the number of hospitalization days between the date of the first dose of investigational product and the date of discharge. ICU stay includes total duration in ICU and may include days in ICU before entry into the study. For participants with a missing discharge date who were not discharged at the end of the study, the date of discharge was imputed to the last follow-up visit (post-treatment +23 days). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to discharge from hospital|ITT-E Population|||Days||Full Range|Median
2730383|NCT01014988|Secondary|Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza|Concomitant medications (prescription and non-prescription) were permitted during the course of the study at the Investigator's discretion (except for prohibited medications: during the treatment period with IV zanamivir, other influenza antiviral drugs were not permitted). The number of participants who were treated with antibiotics for influenza complications was summarized.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
2730384|NCT01014988|Secondary|Number of Participants With Any AE Categorized as an Influenza Complication|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
2730385|NCT01014988|Secondary|Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)|Sustained resolution of the following vital signs (composite) was assessed: afebrile status, normal oxygen saturation, normal respiratory status, normal HR, and normal BP. Clinical response is defined as the resolution of at least four of five vital signs within the following resolution criteria, maintained for 24 hours or hospital discharge, whichever occurred first: Temperature in degrees Centigrade (<=36.6 axilla, <=37.2 oral, <=37.7 rectal, core or tympanic); oxygen saturation (>=95%, without supplemental oxygen); respiratory status (return to pre-morbid oxygen requirement, or no need for supplemental oxygen, or respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute without supplemental oxygen for Cohorts 1-6 respectively); HR (<=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively); SBP (>=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Days||Full Range|Median
2737018|NCT00971997|Secondary|Change From Baseline in Body Weight at Week 48 Endpoint||Baseline, Week 48|Participants who completed treatment through Week 48, and had both baseline and post-baseline value.|||kilogram (kg)||Standard Deviation|Mean
2730389|NCT01014988|Secondary|Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation|"Ventilation status was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Ventilation status was assessed once daily during inpatient follow-up visits. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD) at any time (AT) on study and at Baseline (Day 1) are summarized."|Up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
2730390|NCT01014988|Secondary|Median Time to Resolution of Individual Vital Signs|Times to return to afebrile status (normal body temperature), normal respiratory status, normal heart rate, and normal systolic blood pressure were assessed. Afebrile status is defined as a temperature <=36.6 axilla, <=37.2 oral, or <=37.7 rectal, core or typanic, degrees Centigrade. A return to normal respiratory status is defined as either: (a) return to pre-morbid oxygen requirement; or (b) return to no need for supplemental oxygen; or (c) respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute (without supplemental oxygen) for Cohorts 1-6 respectively . A normal HR is defined as <=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively, and a normal SBP is defined as >=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).|Up to post-treatment (PT) + 23 days|ITT-E Population|||Days||Full Range|Median
2730391|NCT01014988|Secondary|Number of Participants With Treatment-emergent (TE) Mutations|Viral RNA isolated from participants at Baseline (Day 1) and post-Baseline visits were sequenced to determine the presence of TE neuraminidase (NA) and hemagglutinin (HA) mutations resulting from selective pressure. A mutation was considered to be TE if it was not present at Baseline and was present in the last post-Baseline sample analyzed.These mutations were classified as either known to confer zanamvir resistance or novel mutations with unknown clinical significance. Please note: pediatric data are pending and will be updated when available.|Baseline and up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
2730392|NCT01014988|Secondary|Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively|"Viral susceptibility to zanamivir at Baseline and at all post-Baseline visits collectively was assessed by neuraminidase (NA) enzyme inhibition assay. The mean IC50 data are summarized by subtype (A/H1N1, A/H3N2, B) and by visit. IC50 is defined as the concentration of zanamvir required to inhibit NA activity by 50%. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data are not available/analysis was not performed. Please note: pediatric data are pending and will be updated when available."|Baseline and up to post-treatment (PT) + 23 days|ITT-E Population|||Nanomolar (nM)||Standard Deviation|Mean
2730393|NCT01014988|Secondary|Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points|"Change from Baseline in viral load was measured from nasopharyngeal swab samples, as determined by RT-PCR (PCR positive at Baseline). Nasopharyngeal swab samples were collected at Baseline (Day 1); Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10; and, only if the participants had continued symptoms and were hospitalized, post-treatment (PT) samples were collected at +2 days, +5 days, +9 days, +16 days, and +23 days. 'PT +23 days' also comprises viral load values at early study withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). NA indicates that data are not available/analysis was not performed."|Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days|ITT-E Population|||Log10 copies per milliliter||Full Range|Median
2730394|NCT01014988|Secondary|Median Time to Virologic Improvement|Time to virologic improvement is defined as a 2-log drop in viral load or undetectable viral ribonucleic acid (RNA) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples (PCR positive at Baseline). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population consisted of all participants who receiveed at least one dose of IV zanamivir.|||Days||Full Range|Median
2730395|NCT01014988|Primary|Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5|"Twelve-lead ECGs were recorded for the parameters of QTcF and QTcB. The first set of pre-dose ECG values at Baseline (Day 1) and the pre-dose ECG values at Day 5 are presented. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles). NA indicates that data are not available/analysis was not performed. Cohort 1 QTcF and QTcB minimum values of 0.0 were data entry errors that could not be addressed after Data Base Freeze."|Baseline (Day 1) and Day 5|Safety Population|||Milliseconds||Full Range|Median
2730396|NCT01014988|Primary|Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)|The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).|Baseline (Day 1)|Safety Population|||Participants|||Number
2730397|NCT01014988|Primary|Median Body Temperature at Baseline (Day 1) and Day 5|Body temperature was recorded at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Body temperature was recorded once daily during inpatient or outpatient follow-up visits. Median body temperature at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Degrees centigrade||Full Range|Median
2730478|NCT01014741|Primary|Number of Participants With 1 Year Freedom From AF / AT|Freedom from atrial arrhythmia after repeat procedures with or without drugs|one year|Ninety-two patients in the ibutilide group and 93 patients in the placebo group remained in AF after study drug administration and underwent CFAE ablation.|||participants|||Number
2730398|NCT01014988|Primary|Median Respiration Rate at Baseline (Day 1) and Day 5|Respiration rate was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Respiration rate was assessed once daily during inpatient or outpatient follow-up visits. The median respiration rate at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Breaths per minute||Full Range|Median
2730399|NCT01014988|Primary|Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5|TCPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. Because oxygen is carried to tissues by blood flow in the arteries, TCPO2 is an indirect measure of blood flow. The percent (%) oxygen saturation was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Oxygen saturation was assessed once daily during inpatient follow-up visits. The median oxygen saturation values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Percentage of oxygen level in blood||Full Range|Median
2730400|NCT01014988|Primary|Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5|SBP and DBP were measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. SBP and DBP were assessed once daily during inpatient or outpatient follow-up visits. SBP and DBP values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Millimeters of mercury (mmHg)||Full Range|Median
2730401|NCT01014988|Primary|Median Heart Rate at Baseline (Day 1) and Day 5|Heart rate was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Heart rate was assessed once daily during inpatient or outpatient follow-up visits. Heart rate values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Beats per minute (bpm)||Full Range|Median
2730402|NCT01014988|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to post-treatment (PT) + 23 days|Safety Population|||Participants|||Number
2730403|NCT01014988|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included ALT, TB, and creatinine. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to post-treatment (PT) + 23 days|Safety Population|||Participants|||Number
2730404|NCT01014988|Primary|Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5|Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Hematology parameters included hemoglobin, total neutrophils (TN), and white blood cell (WBC) count. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated hematology parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Participants|||Number
2730405|NCT01014988|Primary|Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5|Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Clinical chemistry parameters included alanine aminotransferase (ALT), direct bilirubin (DB), total bilirubin (TB), and creatinine. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated clinical chemistry parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Participants|||Number
2730406|NCT01014988|Primary|Number of Participants Who Were Permanently Discontinued From the Study Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to post-treatment (PT) + 23 days|Safety Population.|||Participants|||Number
2730479|NCT01014728|Secondary|Surgeon's Numeric Rating Scale (SNRS)|The surgeon's numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.|||units on a scale||Full Range|Median
2730407|NCT01014988|Primary|Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to 10 days|Safety Population.|||Participants|||Number
2730408|NCT01014988|Primary|Number of Participants With Any Severe or Grade 3/4 Treatment-related AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.|Up to post-treatment (PT) + 23 days|Safety Population.|||Participants|||Number
2730409|NCT01014988|Primary|Number of Participants With Any Severe or Grade 3/4 AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening.|Up to post-treatment (PT) + 23 days|Safety Population.|||Participants|||Number
2730410|NCT01014988|Primary|Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. All AEs were assesed by the Investigateor as related or not related to the study treatment.|Up to post-treatment (PT) + 23 days|Safety Population: participants who received >=1 dose of study medication.|||Participants|||Number
2730411|NCT01014975|Primary|Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort||90 days|Safety Population|||participants|||Number
2730412|NCT01014936|Secondary|Progression-free Survival (PFS)|PFS was defined as the time (in months) between the first dosing day and radiographic PD or clinical PD (as recorded on the study termination form) or death, if death occurred within 12 weeks (84 days) after the last tumor assessment without documented progressive disease, whichever occurred first. Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment.|Baseline up to 153.3 weeks|"Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||months||90% Confidence Interval|Median
2730413|NCT01014936|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Baseline up to 153.3 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
2730414|NCT01014936|Secondary|Relative Percentage Change In Sum of Longest Diameter (SOLD) of Target Lesions to Post-Baseline Nadir|The post-baseline nadir was defined as the the smallest SOLD recorded after baseline. The relative change (%) was derived based on the SOLD of target lesions as follows: 100* (SOLD at post-baseline nadir - baseline SOLD) / baseline SOLD.|Baseline, On Treatment (up to 153.3 weeks)|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here “Number of Participants Analyzed” signifies those subjects who presented a measurable tumor at baseline and at least one post-baseline tumor assessment.|||percent change||Standard Deviation|Mean
2730415|NCT01014936|Secondary|Number of Subjects With Monovalent Antagonist Antibody to Receptor MET (MetMAb) Score (MMS)|MetMAb score was used to assess the tumor c-Met expression and ranged from 0 to 3, where a score of 0 corresponds to the lowest c-Met expression and a score of 3 corresponds to the highest c-Met expression in tumor tissue by immunohistochemistry.|Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
2730416|NCT01014936|Secondary|Fold Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2|Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. Fold change = on-treatment value/ baseline value|Baseline, Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome and “n” signifies those subjects who were evaluable in the specified category for each arm, respectively.|||fold change||Standard Deviation|Mean
2755458|NCT00839241|Secondary|Interferon Gamma||Day 5 postop||||pg/mL||Standard Deviation|Mean
2730417|NCT01014936|Secondary|Absolute Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2|Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Baseline, Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730418|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 3|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
2730419|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 2|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
2730420|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 1|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
2730421|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 3|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
2730422|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 2|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
2730423|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 1|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
2730424|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 3|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
2730425|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
2730426|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
2730427|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 3|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
2730480|NCT01014728|Secondary|Anesthesiologist Numeric Rating Scale (ANRS)|The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.|||units on a scale||Full Range|Median
2755459|NCT00839241|Secondary|Interferon Gamma||Baseline||||pg/mL||Standard Deviation|Mean
2730428|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
2730429|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
2730430|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 3|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
2730431|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 2|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
2730432|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
2730433|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730434|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730435|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730436|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730437|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730438|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730481|NCT01014728|Primary|Estimated Blood Loss|Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.|from the start of surgery to the end of surgery, up to 6 hours||||mL/h||Standard Deviation|Mean
2730439|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 3|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.||||||
2730440|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 2|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.||||||
2730441|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 1|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.||||||
2730442|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 3|"Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730443|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 2|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730444|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730445|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 3|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730446|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 2|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730447|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve From Time Zero to Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730448|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 3|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2730449|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 2|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2730450|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 1|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2730451|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 3|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2730452|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 2|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2730453|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 1|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2730454|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||hours||Full Range|Median
2730455|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure|||hours||Full Range|Median
2730456|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||hours||Full Range|Median
2730457|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||hours||Full Range|Median
2730458|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48, 49.32 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||hours||Full Range|Median
2730459|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||hours||Full Range|Median
2730460|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2739106|NCT00957359|Secondary|Hopelessness|0-16 (higher score more hopeless)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2730461|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730462|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730463|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730464|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2730465|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2730466|NCT01014936|Secondary|Number of Subjects With Treatment-Emergent AEs (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 158.01 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
2730467|NCT01014936|Primary|Number of Subjects With Treatment-Related Adverse Events|Related AE was defined as any untoward medical occurrence which was considered to have a relationship with the study drug (suspected to be reasonably related to the study drug or AE was medically (pharmacologically/clinically) attributed to the study drug as per Investigator's assessment.|Baseline up to 158.01 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
2730468|NCT01014936|Primary|Recommended Phase 2 Dose (RP2D)|MTD was defined as the dose level at which 2 out of 3 subjects or 2 out of 6 subjects experienced a DLT. The primary endpoint was to determine MTD of MSC2156119J for each of the 3 treatment regimens in subjects with advanced solid tumors. However, during the course of the trial it was established that the MTD could not be determined and instead, RP2D was to be determined.|Cycle 1 (Day 1 to Day 21)|DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1.|||milligram|||Number
2730469|NCT01014936|Primary|Number of Subjects With Any Dose Limiting Toxicity (DLT)|DLT was defined as one of the following adverse events (AEs) observed during Cycle1, regardless of MSC2156119J relationship, excluding AEs assessed by investigator exclusively related to subject's underlying disease or medical condition: Grade 4 neutropenia for >7 days; Grade >=3 febrile neutropenia for >1 day; Grade 4 thrombocytopenia/Grade 3 with bleeding; Grade >=3 nausea and emesis, despite optimal treatment; Grade >=3 non-hematological AE, except emesis and nausea with no adequate therapy and alopecia, Grade >= 3 liver AE with a recovery period of >7 days or to Grade <=1 for subjects without liver metastases or to <=2 for subjects with liver metastases; Grade >=3 lipase and/or amylase rise with pancreatitis confirmation, either based on clinical or radiological signs. Any AE not otherwise defined as a DLT that, due to prolonged recovery to Grade <=1 or baseline status, leads to delay of above 21 days in planned administration of study drug.|Day 1, 3, 8, 14, 17 of Cycle 1 (for Regimen 1 and 3); Day 1, 3, 8, 15, 19 of Cycle 1 (for Regimen 2)|DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1.|||subjects|||Number
2730470|NCT01014910|Secondary|Clinical Deterioration Necessitating Transfer to Higher Level of Care||Summarized from admission to hospital discharge||||participants|||Number
2730471|NCT01014910|Primary|Length of Stay in the Hospital||Summarized from admission to hospital discharge||||hours||Inter-Quartile Range|Median
2730472|NCT01014871|Primary|Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead|Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.|5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5|Intention To Treat|||Scores on a scale||Standard Deviation|Mean
2730473|NCT01014767|Primary|Toxicity During First 4 Months of Therapy|PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available|4 Months|PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available||||||
2730797|NCT01012167|Secondary|Side Effect Checklist (SEC) - Sore Throat|"Percentage of participants with new onset or worsening compared to baseline of Sore Throat rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730482|NCT01014689|Secondary|Success Rate on the Investigator's Global Assessment (IGA) at Week 12|"Percentage of Subjects Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12."|Baseline and Week 12|Intention To treat - Last Observation Carried Forward|||percent of subjects|||Number
2730483|NCT01014689|Primary|Percent Change From Baseline in Total Lesion Count|Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.|Baseline and Week 12|Intention to treat - Last observation carried forward|||percent of change||Full Range|Median
2730484|NCT01014624|Secondary|Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose.|Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to R-to-B PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to R-to-B PRU derived from: Number days to R-to-B PRU=-3.350+0.079*PI(1)+0.014*baseline PRU.|up to 12 days after the last dose|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.|||days to return to baseline PRU|||Number
2730485|NCT01014624|Secondary|Percentage of Platelet Inhibition on Washout Day 1|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|Washout Day 1|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3).|||Percentage||Standard Deviation|Mean
2730486|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%|up to 12 days after the last dose|Subjects in Responder Pop. using secondary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Pop. was primary pop. excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) <= 20%|||day50%, 75%, 90% returned to baseline|||Number
2730487|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Responder Pop. using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Pop. was Primary Pop. excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units|||day 50%, 75%, 90% returned to baseline|||Number
2730488|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using secondary definition of return to baseline. Primary Population included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%|||day 50%, 75%, 90% returned to baseline|||Number
2730489|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using primary definition of return to baseline. Primary population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units|||day 50%, 75%, 90% returned to baseline|||Number
2730490|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline.|On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|up to 12 days after last dose|Subjects in Primary Pop. using secondary definition of return to baseline. Primary Population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%|||cumulative percent returned to baseline|||Number
2730491|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of subjects.|up to 12 days after last dose|Subjects in Primary Population (Pop.) using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units.|||cumulative percentage of subjects|||Number
2730492|NCT01014585|Secondary|Time to Worsening in Multidimensional Assessment of Fatigue (MAF)|Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.|||Days||95% Confidence Interval|Median
2730493|NCT01014585|Secondary|Time to Worsening in Patient Global Impression of Change (PGIC)|"Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse."|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.|||Days||95% Confidence Interval|Median
2730494|NCT01014585|Primary|Time to Loss of Therapeutic Response (LTR)|Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.|||Days||95% Confidence Interval|Median
2730495|NCT01014533|Secondary|Relapse to Any Drinking|Relapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later|12 weeks||||Participants|||Count of Participants
2730496|NCT01014533|Primary|Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication|Wake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset)|1 week||||minutes||Standard Deviation|Mean
2730497|NCT01014533|Primary|Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)|Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep|1 week||||percentage of total sleep time||Standard Deviation|Mean
2730498|NCT01014455|Primary|Exhaled CO Level Measured Immediately Prior to Surgery|On the morning of surgery, as matter of clinical routine all patients receiving surgery requiring anesthesia services at one of the two main surgical facilities at Mayo Clinic Rochester and who self-report as a current smoker are asked about their typical cigarette consumption (cigarettes per day), if they have smoked cigarettes today, and have their exhaled CO levels measured (Micro Smokerlyzer; Bedfont, United Kingdom). This information is entered into the clinical record. The CO monitors are maintained by the Division of Respiratory Therapy, including regular calibration.|The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.|5 participants did not complete CO measures and were excluded from the analysis of primary outcome|||ppm||Standard Deviation|Mean
2730499|NCT01014455|Primary|Preoperative Carbon Monoxide Levels||the morning of surgery|||||||
2730500|NCT01014442|Secondary|Percentage of Participants With Opportunistic Infections|Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.|Up to Day 90|Safety Population|||percentage of participants|||Number
2730501|NCT01014442|Secondary|Change From Baseline in T-Cell Phenotype|Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.|Baseline, Days 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||percentage of lymphocytes||Standard Deviation|Mean
2730502|NCT01014442|Secondary|Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels|iATP was expressed in ng/mL.|Baseline, Days 4, 8, 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||ng/mL||Standard Deviation|Mean
2730503|NCT01014442|Secondary|Forced Vital Capacity (FVC) at Day 90 Post-Transplantation|FVC at Day 90 post-transplantation is reported.|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||L||Standard Deviation|Mean
2730504|NCT01014442|Secondary|Percent of Predicted FEV1 at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100%|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||percentage of predicted FEV1||Standard Deviation|Mean
2730505|NCT01014442|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 90 post-transplantation|ITT Population (total 64 participants). Here, Number of participants analyzed = participants evaluable for this outcome measure.|||L||Standard Deviation|Mean
2730506|NCT01014442|Primary|Free Fraction of Free MPA at Day 90|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
2730507|NCT01014442|Primary|Free Fraction of Free MPA at Day 20|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
2730508|NCT01014442|Primary|Free Fraction of Free MPA at Day 8|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
2730509|NCT01014442|Primary|Free Fraction of Free MPA at Day 4|MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
2730510|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
2730511|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
2730512|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
2730513|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
2730514|NCT01014442|Primary|AUC0-12 of Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
2730515|NCT01014442|Primary|AUC0-12 of Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
2730516|NCT01014442|Primary|AUC0-12 of Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
2730517|NCT01014442|Primary|AUC0-12 of Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
2730518|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours*(mg/L)||Standard Deviation|Mean
2755460|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 8 postop||||Percent||Standard Deviation|Mean
2730519|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*(mg/L)||Standard Deviation|Mean
2730520|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*(mg/L)||Standard Deviation|Mean
2730521|NCT01014442|Primary|Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*(mg/L)||Standard Deviation|Mean
2730522|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 90|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||L/hour||Standard Deviation|Mean
2730523|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 20|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||L/hour||Standard Deviation|Mean
2730524|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 8|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||L/hour||Standard Deviation|Mean
2730525|NCT01014442|Primary|Clearance (CL) of MPA, MPAG and AcMPAG at Day 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||L/hours||Standard Deviation|Mean
2730526|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 90|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
2730527|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 20|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
2730528|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 8|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
2730529|NCT01014442|Primary|Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
2730530|NCT01014442|Primary|Cmin of Free MPA at Day 90|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730531|NCT01014442|Primary|Cmin of Free MPA at Day 20|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730532|NCT01014442|Primary|Cmin of Free MPA at Day 8|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730533|NCT01014442|Primary|Cmin of Free MPA at Day 4|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730534|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 90|Cmin was expressed in mg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
2730535|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 20|Cmin was expressed in mg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
2730536|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 8|Cmin was expressed in mg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
2730537|NCT01014442|Primary|Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4|Cmin was expressed in mg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
2730538|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
2730539|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
2730540|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
2730541|NCT01014442|Primary|Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
2730542|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
2730543|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
2730544|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
2730545|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4|Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
2730546|NCT01014442|Primary|Cmax of Free MPA at Day 90|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730547|NCT01014442|Primary|Cmax of Free MPA at Day 20|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730548|NCT01014442|Primary|Cmax of Free MPA at Day 8|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730549|NCT01014442|Primary|Cmax of Free MPA at Day 4|Cmax was expressed in micrograms per liter (mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
2730550|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 90|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
2730551|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 20|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
2730552|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 8|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
2730564|NCT01014208|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause. Participants who were still alive by the end of the study were censored.|From randomization to death due to any cause (assessed for up to 5 years)|ITT Population|||Months||95% Confidence Interval|Median
2730553|NCT01014442|Primary|Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4|Cmax was expressed in milligrams per liter (mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation|Per Protocol (PP) Population: Intent-to treat (ITT) population (received at least one dose of study drug and where the primary variable was measured at least once under study drug) excluding participants with major protocol violations (total 46 participants). Number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
2730554|NCT01014390|Primary|Stent Removability|Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.|At stent removal|10 Patients were excluded because of death (from unrelated cause), withdrawal of consent, or switch to palliative treatment.|||Participants|||Count of Participants
2730555|NCT01014351|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||percentage of patients|||Number
2730556|NCT01014351|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from randomization until death from any cause.|18 months||||Months||95% Confidence Interval|Median
2730557|NCT01014351|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months||||Months||95% Confidence Interval|Median
2730558|NCT01014208|Secondary|Time to Engraftment After High-dose Therapy (HDT)/ASCT|Engraftment is defined as 1) three consecutive days when the ANC is ≥0.5x109/L and 2) an unsupported platelet count of ≥20x109/L, and the engraftment date is the date that this occurs. If engraftment was not achieved by Day 42 or the last observation, engraftment was deemed to be a failure, and censoring took place at Day 42 or at the last observation.|From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)|Safety population. Only participants completing HDT/ASCT are included.|||Days||95% Confidence Interval|Median
2730559|NCT01014208|Secondary|Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy|Neutrophil (absolute neutrophil count [ANC]) recovery is defined as ANC >=0.5*10^9/Liter and increasing, and platelet (PLT) recovery is defined as PLT >=10*10^9/Liter and increasing. For each cycle, time to ANC recovery is defined as the time from the first dose to the first ANC >=0.5*10^9/Liter and increasing after the nadir in the cycle. For each cycle, time to PLT recovery is defined as the time from the first dose to the first PLT >=10*10^9/L and increasing after the nadir in the cycle.|From the start of each cycle for a maximum of 5 weeks per cycle (assessed during treatment period of Baseline up to approximately 3 months)|Safety Population. Only those participants available for analysis in the given cycle were assessed.|||days||95% Confidence Interval|Median
2730560|NCT01014208|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment|"The FACT-Lym TOI is a measure that combines the FACT-Lym subscale (15 items; responses to each item range from 0, Not at all to 4, Very much) with two domains taken from the FACT-G (responses to each item range from Not at all  to Very much): Physical Well-being (7 items: lack of energy, nausea, meeting family needs, pain, side effects, feels ill, spends time in bed) and Functional Well-being (7 items: ability to work, work fulfilment, ability to enjoy life, illness acceptance, ability to sleep well, enjoying things done for fun, satisfaction with quality of life). This index is designed to be sensitive to changes in treatment regimens. The total FACT-Lym TOI score ranges from 0 to 116; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.|||scores on a scale||Standard Error|Mean
2730561|NCT01014208|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment|"The FACT-G was developed by the Functional Assessment of Chronic Illness Therapy (FACIT) group for use in adults in a wide range of oncology clinical trial populations. The 27 items of the FACT-G are scored in the following domains: Physical Well-being (7 items), Social/Family Wellbeing (7 items), Emotional Well-being (6 items), and Functional Well-being (7 items). Participants responded to the items on a five-point Likert scale ranging from 0, Not at all to 4, Very much. The total score ranges from 0 to 108; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.|||scores on a scale||Standard Error|Mean
2730562|NCT01014208|Secondary|Number of Participants Completing Autologous Stem Cell Transplant (ASCT)|The number of participants who completed ASCT is reported.|Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)|ITT Population|||Participants|||Number
2730563|NCT01014208|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood|Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization is defined as the collection of >2*10^6 CD34+ cells/kg. Only those participants, who commenced harvest, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of CD34+ stem cells (at least 2*10^6 CD34+ cells/kg) after dosing of salvage therapy in Cycle 2 and Cycle 3 was analyzed.|During Cycles 2 and/or 3 (Weeks 4-9)|ITT Population. Only participants commencing leukapheresis are included.|||Participants|||Number
2730820|NCT01012167|Secondary|Laboratory Measures - BUN|BUN blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730565|NCT01014208|Secondary|Event-free Survival|Event-free survival is defined as the time from randomization to progressive disease (PD; disease whose course is growth, or spread of the disease), stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for PD) after completion of 2 cycles of therapy, commencement of a new treatment for diffuse large B cell lymphoma (DLBCL) (e.g., radiotherapy), or death from any cause, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization to progressive disease, stable disease after completion of 2 cycles of therapy, commencement of a new treatment for DLBCL, or death due to any cause (assessed for up to 5 years)|ITT Population|||Months||95% Confidence Interval|Median
2730566|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)|ITT Population. Only participants completing HDT/ASCT are included.|||Participants|||Number
2730567|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)|ITT Population|||Participants|||Number
2730568|NCT01014208|Primary|Progression-free Survival as Assessed by Independent Reviewers|Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease [PD]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)|Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug)|||Months||95% Confidence Interval|Median
2730569|NCT01014169|Secondary|Maternal Practice Related to Correct Car Seat Use|Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.|two days after discharge||||participants with correct car seat use|||Number
2730570|NCT01014169|Secondary|Maternal Practice Related to Breastfeeding Initiation|This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.|two days after discharge||||participants who report breastfeeding|||Number
2730571|NCT01014169|Primary|The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.|This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.|two days after discharge||||participants who report supine position|||Number
2730572|NCT01014143|Primary|Plaque Index|Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Four days|per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.|||Units on a scale||Standard Deviation|Mean
2730573|NCT01014091|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730574|NCT01014091|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730575|NCT01014091|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)|Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730615|NCT01013753|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|4 weeks|Treated Set|||Participants|||Number
2730576|NCT01014091|Secondary|Number of Subjects With Any Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the entire study period (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730577|NCT01014091|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever > 39.0 °C.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730578|NCT01014091|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730579|NCT01014091|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2730580|NCT01014091|Secondary|Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2730581|NCT01014091|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Participants|||Count of Participants
2730582|NCT01014091|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below < 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Participants|||Count of Participants
2730583|NCT01014091|Secondary|HI Antibody Titers Against Vaccine H1N1 Antigen|Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2730584|NCT01014091|Secondary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Participants|||Count of Participants
2730585|NCT01014091|Primary|Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2730616|NCT01013753|Secondary|Potassium 3 Hours Post-dose|Effect on potassium evaluated 3 hours post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set|||mmol/L||95% Confidence Interval|Geometric Mean
2730586|NCT01014091|Primary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Participants|||Count of Participants
2730587|NCT01014091|Primary|Number of Seroconverted Subjects in Terms of HI Antibodies|Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Participants|||Count of Participants
2730588|NCT01014091|Primary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Participants|||Count of Participants
2730589|NCT01014091|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen|Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2730590|NCT01014013|Secondary|Clinical Response Assessment Profile|The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)|||Participants|||Number
2730591|NCT01014013|Primary|The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment|Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.|Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days|Safety Analysis has been done 267 patients who received at least 1 dose of parenteral therapy (132 patients from MK0826 and 135 patients from Ceftriaxone)|||Participants|||Number
2730592|NCT01014013|Primary|Microbiological Response Assessment Profile|The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)|||Participants|||Number
2730593|NCT01013961|Secondary|Duration of Response|Duration of response is defined to be time from first confirmed CR, PR or clinical CR to progression or to death without documentation of progression. Patients without confirmed CR, PR or clinical CR are censored at time 0. Those without documentation of progression are censored at the date of last disease assessment without progression, unless death occurs within three months following the date last known progression free.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
2730594|NCT01013961|Secondary|Time to Response|Time to response is defined to be time from randomization to first confirmed CR, PR or clinical CR. Those without confirmed CR, PR or clinical CR are censored at the date of last disease assessment.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
2730595|NCT01013961|Secondary|Progression-free Survival (PFS)|"PFS is defined to be time from randomization to progression (PD) or to death without documentation of progression. For patients without PD, follow-up is censored at the date of last disease assessment without PD, unless death occurs within three months following the date last known progression free.~PD is characterized by at least one of the following:~≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart (at least 1 node must be >2 cm). Appearance of new palpable lymph nodes (>1 cm in diameter).~≥50% increase in the size of liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly which was not previously present.~Absolute number of circulating lymphocytes with a count of >5x10^9/L~Transformation to a more aggressive histology"|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
2730596|NCT01013961|Secondary|Overall Survival (OS)|OS is defined to be time from randomization to death from any cause. Those still alive are censored at the date of last contact.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
2730617|NCT01013753|Secondary|Potassium 1 Hour Post-dose|Effect on potassium evaluated 1 hour post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set|||mmol/L||95% Confidence Interval|Geometric Mean
2739107|NCT00957359|Secondary|Death Transcendence Scale|0-60 (higher score more death transcendence)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2730597|NCT01013961|Primary|Proportion of Patients With Overall Response (OR)|"OR is defined as either CR, clinical CR, or partial response (PR) evaluated by NCI-WG96 criteria. CR has been defined in the other primary endpoint.~A clinical CR requires all of the following:~Absence of lymphadenopathy by physical examination~No hepatomegaly or splenomegaly. Spleen and/or liver, if considered enlarged at baseline, should not be palpable, due to disease, on physical exam~Absence of constitutional symptoms~Normal CBC as exhibited by:~A PR requires all the following for ≥2 months:~≥50% decrease in peripheral blood lymphocyte count from baseline~≥50% reduction in lymphadenopathy~≥50% reduction in size of liver and/or spleen~Polymorphonuclear leukocytes ≥1.5x10^9/L or 50% improvement over baseline~Platelets >100x10^9/L or 50% improvement over baseline~Hemoglobin >11.0 gm/dl or 50% improvement over baseline without transfusions~Any constitutional symptoms"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2730598|NCT01013961|Primary|Proportion of Patients With Complete Response (CR)|"Response was evaluated using NCI-WG96 criteria.~A CR requires all of the following for >= 2 months:~Absence of lymphadenopathy > 1 cm in diameter by physical examination~No hepatomegaly or splenomegaly on physical exam~No constitutional symptoms~Normal complete blood count (CBC)~Patients achieving a clinical CR with negative CT scan after 2 cycles of therapy are re-evaluated using immunohistochemical examination of bone marrow biopsy for residual CLL cells. Patients with no evidence of residual disease and no radiological evidence of residual CLL on CT scan of chest-abdomen-pelvis and no clinical evidence of CLL on clinical evaluation after completion of 2 cycles of therapy will be considered to have a CR with no evidence of residual disease"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2730599|NCT01013883|Secondary|Admission to Hospital for Any Cause|Number of patients admitted to the hospital will be recorded|During the follow up period of 7 years||||participants|||Number
2730600|NCT01013883|Secondary|Cardiovascular Mortality||Patients would be followed up for average of 7years||||participants|||Number
2730601|NCT01013883|Primary|All Cause Mortality||Patients would be followed up for average of 7 years||||participants|||Number
2730602|NCT01013870|Secondary|Symbol Digit Modalities Test - Written Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730603|NCT01013870|Secondary|Symbol Digit Modalities Test - Oral Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730604|NCT01013870|Secondary|Brief Visuospatial Memory Test - Revised|The BVMT-R is a measure of visuospatial memory. Six equivalent, alternate stimulus forms consist of six geometric figures printed in a 2 x 3 array on separate pages. In three Learning Trials, the subject views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Scoring of the immediate and delayed recall are based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730605|NCT01013870|Secondary|Center for Epidemiological Study Depression Scale|The CES-D is a widely used screening scale for depression, assessing depressive feelings and behaviors occurring in the past week of a patient's life. The CES-D consists of 20 items, which make up six scales reflecting depressive symptomatology: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Each item is scored on a 4-point scale ranging from 0 (rarely/none of the time) to 3 (most/all of the time). Scores for items 4, 8, 12, and 16 are reversed before summing all items to yield a total score, which can range from 0-60. Higher scores indicate more depressive symptoms. (Radloff, LS [1977]. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas, 1, 385-401.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730821|NCT01012167|Secondary|Laboratory Measures - Protein|Protein blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
2730606|NCT01013870|Secondary|Connor Davidson Resilience Measure|The Connor-Davidson Resilience scale (CD-RISC) has 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The sum score has a range from 0 to 100. (Conner KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale [CD-RISC]. Depress Anxiety 18[2]:76-82,2003].|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730607|NCT01013870|Secondary|Post-traumatic Stress Checklist - Civilian Form|"The Post Traumatic Stress Disorder Checklist (PCL) is a 17-item self report measure of the DSM-IV symptoms of PTSD. Respondents rate how much they were bothered by a symptom on a 5-point scale ranging from 1 (not at all) to 5 (extremely). The PCL was scored as a total score (range 17-85), with higher total scores indicating more symptoms. (Weathers, F., Litz, B., Herman, D., Huska, J., & Keane, T. [October 1993]. The PTSD Checklist [PCL]: Reliability, Validity, and Diagnostic Utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX.)"|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730608|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Physical Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730609|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Mental Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
2730610|NCT01013870|Primary|Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.|The Rivermead Post-Concussive Symptoms Questionnaire (RPQ) is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms found in the literature. The scale compares any current symptoms to pre-injury symptom levels to account for potential symptom exacerbation due to TBI. The range of scores is 0-64. Values for each of the 16 items include 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), 4 (severe problem). The total score was a summation of symptoms that represented new symptom onset or an exacerbation of a symptom present pre-injury. (King, N.S., Crawford, S., Wenden, F.J., Moss, N.E., & Wade, D.T. [1995]. The Rivermead Post Concussion Symptoms Questionnaire: A Measure of Symptoms Commonly Experiences after Head Injury and its Reliability. Journal of Neurology 242: 587-92.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Full Range|Median
2730611|NCT01013844|Primary|Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.|4 months||||Number of times reviewed SSE guidelines||Standard Deviation|Mean
2730612|NCT01013844|Primary|Mean Number of Skin Examinations With Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.|4 months||||Times examined skin with a partner||Standard Deviation|Mean
2730613|NCT01013844|Primary|Mean Number of Skin Examinations Without Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.|4 months||||Times examined skin by self||Standard Deviation|Mean
2730614|NCT01013792|Primary|Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit|A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.|up to 8 weeks|All participants that are randomized|||percent change of baseline area||Full Range|Median
2730618|NCT01013753|Secondary|Potassium 1 Hour Pre-dose|Effect on potassium evaluated 1 hour pre-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set|||mmol/L||95% Confidence Interval|Geometric Mean
2730619|NCT01013753|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.|||units on a scale||Standard Error|Mean
2730620|NCT01013753|Secondary|Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.|||units on a scale||Standard Error|Mean
2730621|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of patients|||Number
2730622|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of patients|||Number
2730623|NCT01013753|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of patients|||Number
2730624|NCT01013753|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM2+ device.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Percentage of asthma symptom free days||Standard Error|Mean
2730625|NCT01013753|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of Puffs||Standard Error|Mean
2730626|NCT01013753|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||L||Standard Error|Mean
2730627|NCT01013753|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||L||Standard Error|Mean
2730628|NCT01013753|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Percentage||Standard Error|Mean
2730629|NCT01013753|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Liter/min||Standard Error|Mean
2730630|NCT01013753|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Liter/min||Standard Error|Mean
2730631|NCT01013753|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
2730632|NCT01013753|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
2730729|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|6 months||||participants|||Number
2730633|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
2730634|NCT01013753|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
2730635|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
2730636|NCT01013753|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730637|NCT01013753|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730638|NCT01013753|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730639|NCT01013753|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730640|NCT01013753|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730641|NCT01013753|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730642|NCT01013753|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730643|NCT01013753|Secondary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2755461|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 5 postop||||Percent||Standard Deviation|Mean
2730644|NCT01013753|Secondary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
2730645|NCT01013753|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.|||Liter||Standard Error|Mean
2730646|NCT01013740|Secondary|Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE.|From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)|Safety Population: participants who received at least one dose of study medication, based on the actual treatment received|||participants|||Number
2730647|NCT01013740|Secondary|Maximum Concentration (Cmax) for Vinorelbine|Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose|||||||
2730648|NCT01013740|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine|AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose|||||||
2730649|NCT01013740|Secondary|Number of Participants With Clinical Benefit (CB) in the Randomized Phase|CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population|||participants|||Number
2730650|NCT01013740|Secondary|Time to Response in the Randomized Phase|Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for time to response.|||weeks||95% Confidence Interval|Median
2730651|NCT01013740|Secondary|Duration of Response (DOR) in the Randomized Phase|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||months||95% Confidence Interval|Median
2730652|NCT01013740|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From the date of randomization until death (average of 55 study weeks)|ITT Population|||months||95% Confidence Interval|Median
2730653|NCT01013740|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population|||participants|||Number
2730730|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|3 months||||Participants|||Number
2737019|NCT00971997|Secondary|Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||mg/dL||Standard Deviation|Mean
2730654|NCT01013740|Primary|Progression Free Survival (PFS) in the Randomized Phase|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population: participants who were randomized to study treatment, regardless of whether they actually received study medication|||months||95% Confidence Interval|Median
2730655|NCT01013701|Secondary|To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.||18 weeks|No data was collected/is available for the study as it was terminated prematurely and the PI has since left the institution.||||||
2730656|NCT01013701|Primary|To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.||18 weeks|The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board.||||||
2730657|NCT01013597|Secondary|Tolerability of LBH589|Tolerability and toxicity were not assessed separately, therefore tolerability is reported as toxicity.|Every 4 weeks, up to 5 years|||||||
2730658|NCT01013597|Secondary|Toxicity of LBH589|Most frequent toxicities at least possibly related to panobinostat, grades 2-4 (grading based on NCI common terminology criteria for adverse events CTCAE version 3). Toxicities were collected from the time the patient provided informed consent until 4 weeks after the patient stopped LBH589.|Every 4 weeks, up to 5 years||||participants|||Number
2730659|NCT01013597|Secondary|Impact of LBH589 on Tumor Markers for Thyroid Cancer|Change in serum Thyroglobulin level from baseline to end of treatment. Treatment continued until either extraordinary medical circumstances, disease progression, toxicity, subject withdrawal, or death. At the time subjects came off of study treatment for one of the reasons already listed, a sample was collected for tumor markers.|Baseline and end of treatment, up to 1 year||||ng/mL||Standard Deviation|Mean
2730660|NCT01013597|Secondary|Overall Survival|For a given patient, overall survival (OS) is defined as the number of days from the day of first LBH589 administration until the patient's death. If a patient was alive at the time of analysis, then the patient's data is censored at the date of the last available evaluation.Survival was assessed every three months until death or final data analysis, whichever occurred first.|Every 3 months up to 5 years||||months||95% Confidence Interval|Median
2730661|NCT01013597|Secondary|Time to Progression of Thyroid Cancer|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is defined as the number of days from the day of first LBH589 administration to the day the patient experienced an event of disease progression or death, whichever came first. Progression was assessed every 3 months until death or up to 5 years, whichever occurred first.|Every 3 months until progression up to 5 years||||months||95% Confidence Interval|Median
2730662|NCT01013597|Secondary|Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.||End of study|Notch1 protein expression was not measured due to lack of efficiency of study intervention||||||
2730663|NCT01013597|Primary|Tumor Response Rate to LBH589.|"per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: Response includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, >=30% decrease in the sum of the longest diameter of target lesions). No Response includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).)"|Every 8 weeks.||||participants|||Number
2730664|NCT01013350|Secondary|Number of Participants With Pregnancy Outcomes|Pregnancies occurred among female participants exposed to cladribine were identified by a participant-reported positive pregnancy test and at least a 2-week delay in menses, or a participant-reported pregnancy diagnosed by a physician. Pregnancy outcomes were Live birth, Induced abortion (Termination), Spontaneous loss (Miscarriage) (< 22 weeks), Foetal death (stillbirth) (>=22 weeks), Ectopic pregnancy, Congenital malformations and others (unknown). Number of participants as per pregnancy outcome category were reported.|up to 3251 days|"Safety analysis set. Here, Overall Number of Participants Analyzed signifies number of participants with pregnancies."|||Participants|||Count of Participants
2730665|NCT01013350|Primary|"Number of Participants With Adverse Events (AEs) in the Blood and Lymphatic System Disorders System Organ Class (SOC) and in the Neoplasms Benign, Malignant, and Unspecified SOC"|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug.|up to 3251 days|Safety analysis set included all participants in the current study who either received placebo matched to cladribine or cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537, NCT00725985).|||Participants|||Count of Participants
2730666|NCT01013350|Primary|Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia|"Persistent lymphopenia was defined as Grade 3 (less than [<] 500-200 per millimeter [mm] ^3 or < 0.5-0.2 multiply [*]10^9 per Liter) or Grade 4 (< 200/mm^3 or < 0.2*10^9 per Liter) lymphopenia as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The resolution is the achievement of a CTCAE Grade 1 (< lower limit of normal [LLN] to 800 per mm^3 or < LLN to 0.8*10^9 per Liter) or Grade 0 (< 910 per mm^3 ) lymphocyte count. Persistent Lymphopenia was reported only in Cladribine group, hence results are reported only for Exposed to Cladribine arm. Time to resolution is reported."|up to 3251 days|"Lymphocyte Population included participants from safety analysis set who had persistent lymphopenia. Here, overall number of participants analyzed signified participants with resolved lymphopenia."|||months||Standard Deviation|Mean
2757830|NCT00821951|Secondary|Vorinostat Modification of the DNA Damage Response in Patient Samples||1 Year|||||||
2730667|NCT01013350|Primary|Number of Participants With Serious Adverse Drug Reactions (SADRs)|SADR is an adverse drug reaction that fulfils at least one of the seriousness criterion; results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is otherwise considered as medically important. An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the restoration, correction, or modification or physiological functions. Number of participants with SADRs were reported.|up to 3251 days|Safety analysis set included all participants in the current study who either received placebo matched to cladribine or cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537 and NCT00725985).|||Participants|||Count of Participants
2730668|NCT01013207|Secondary|Usability of the Nexus (S9) CPAP.|The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.|4 weeks||||Units on a scale||Standard Deviation|Mean
2730669|NCT01013207|Primary|Compliance on CPAP|Compliance on CPAP was measured as average daily usage|12 weeks||||Hours||Standard Deviation|Mean
2730670|NCT01013194|Secondary|Analysis of Meld Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Meld score.~The Model for End-stage Liver Disease (MELD) scoring system aims at stratifying recipients by their disease severity according to a score estimating the 3-month probability of death on the waiting list. The calculation of an individual's MELD score is based on three objective lab parameters (bilirubin, serum creatinine and prothrombin time expressed as international normalized ratio, INR) and it includes logarithmic transformations and multiplication by several factors. It ranges between 6 and 40. The highest is the score the lower is the patient's survival."|Baseline and 1 year Follow-up||||units on a scale||Standard Deviation|Mean
2730671|NCT01013194|Secondary|Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Child-Pugh score.~The Child-Pugh (CP) classification is a scoring system used for the classification of the severity of cirrhosis. It includes three continuous variables (bilirubin, albumin and INR) and two discrete variables (ascites and encephalopathy). Each variable is scored 1-3 with 3 indicating most severe derangement. The determination of CP score may range from 5 to 15 and the final score allows to categorize patients in Child-Pugh A (5-6 points), B (7-9 points) and C (10-15 points). The highest is the score the sickest is the patient."|Baseline and 1 year Follow-up|Baseline Child-Pugh score vs Follow-up|||units on a scale||Standard Deviation|Mean
2730672|NCT01013194|Primary|Patient Survival|Assessment of treated and control patients survival at 1 year follow-up|1 year||||participants|||Number
2730673|NCT01012999|Primary|Pain Relief at Thirty Minutes|Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).|30 min post dose||||Units on a scale||Standard Deviation|Mean
2730674|NCT01012973|Secondary|Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||Scores on a scale||Standard Deviation|Mean
2730675|NCT01012973|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||Scores on a scale||Standard Deviation|Mean
2730676|NCT01012973|Secondary|Percentage of Participants Who Developed Neovascularization During the First 24 Weeks|Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24|From baseline until Week 24|Full analysis set|||Percentage of participants|||Number
2730677|NCT01012973|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||microns||Standard Deviation|Mean
2730678|NCT01012973|Secondary|Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.|Baseline and Week 24|Full analysis set|||Letters correctly read||Standard Deviation|Mean
2730679|NCT01012973|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline and Week 24|Full analysis set|||Percentage of participants|||Number
2730690|NCT01012739|Secondary|Indacaterol Exposure (Cmax) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.|||pg/mL||Standard Deviation|Mean
2757831|NCT00821951|Secondary|Target Lesion Response||1 Year|||||||
2730680|NCT01012947|Primary|Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group|"The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment.~In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation."|baseline and 18 months|The location of the survey was Suwon City, with a population of 1 million, located adjacent to Seoul, the nation's capital. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.|||units on a scale||Standard Deviation|Mean
2730681|NCT01012921|Primary|The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.|Change between baseline (regenerative therapy) and the 6 months timepoint is reported.|Assessed at 6 months reported|PP|||mm||Standard Deviation|Mean
2730682|NCT01012765|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 20 days were included in the analysis.|||Liters||95% Confidence Interval|Least Squares Mean
2730683|NCT01012765|Secondary|FEV1 30 Minutes Post-dose After 21 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.|||Liters||95% Confidence Interval|Least Squares Mean
2730684|NCT01012765|Secondary|Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment|Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.|||kPa*sec||95% Confidence Interval|Least Squares Mean
2730685|NCT01012765|Secondary|Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment|Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.|||Ratio||95% Confidence Interval|Least Squares Mean
2730686|NCT01012765|Secondary|Peak Total Lung Capacity (TLC) After 21 Days of Treatment|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.|||Liters||95% Confidence Interval|Least Squares Mean
2730687|NCT01012765|Secondary|Peak Residual Volume (RV) After 21 Days of Treatment|Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.|||Liters||95% Confidence Interval|Least Squares Mean
2730688|NCT01012765|Secondary|Trough IC After 20 Days of Treatment|Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 20 days were included in this analysis.|||Liters||95% Confidence Interval|Least Squares Mean
2730689|NCT01012765|Primary|Peak Inspiratory Capacity (IC) After 21 Days of Treatment|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.|||Liters||95% Confidence Interval|Least Squares Mean
2730723|NCT01012492|Primary|Percentage of Participants With Grade III-IV Acute GVHD by Day 100.|Grade III-IV Acute GVHD by Day 100. The incidence of Gr III-IV acute GVHD was measured by the modified Glucksburg scale.|Day 100 post-transplant||||percentage of participants|||Number
2730724|NCT01012440|Primary|Reduction in Tumor Size|Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.|1-2 weeks post treatment onset|This study has been terminated due to poor accrual.|||mm||Standard Deviation|Mean
2759979|NCT00807742|Primary|Average Number of Cigarettes Per Day||1-month follow up||||cigarettes||Standard Deviation|Mean
2730691|NCT01012739|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.|||pg*hr/mL||Standard Deviation|Mean
2730692|NCT01012739|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|From 5 minutes to 4 hours post-dose for each treatment|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||Standard Deviation|Mean
2730693|NCT01012739|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|From 5 minutes to 12 hours post-dose|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Hours||Standard Deviation|Mean
2730694|NCT01012739|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||Standard Deviation|Mean
2730695|NCT01012739|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||Standard Deviation|Mean
2730696|NCT01012713|Secondary|A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.||12 weeks||||percent||95% Confidence Interval|Number
2730697|NCT01012713|Secondary|The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.||8 weeks||||percent||95% Confidence Interval|Number
2730698|NCT01012713|Primary|The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.||12 weeks||||percent||95% Confidence Interval|Number
2730699|NCT01012674|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2 - 42 days||||percentage of arterial segments|Participants|95% Confidence Interval|Number
2730700|NCT01012674|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2-42 days||||percentage of arterial segments|Participants|95% Confidence Interval|Number
2730701|NCT01012674|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).|2 - 28 days||||percentage of arterial segments|Participants|95% Confidence Interval|Number
2730702|NCT01012661|Primary|Patients With Clinically Significant Reduction in Pain|Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)||||Participants|||Number
2730703|NCT01012661|Primary|Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)|Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)||||cm||Standard Deviation|Mean
2730704|NCT01012622|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||participants|||Number
2730705|NCT01012622|Secondary|Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2730706|NCT01012622|Secondary|Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12|"Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from never to very truly. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent."|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730707|NCT01012622|Secondary|Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12|Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730708|NCT01012622|Secondary|Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12|APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730709|NCT01012622|Secondary|Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||correct responses||Standard Deviation|Mean
2730710|NCT01012622|Secondary|Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||correct responses||Standard Deviation|Mean
2730711|NCT01012622|Secondary|Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730712|NCT01012622|Secondary|Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730725|NCT01012414|Secondary|Effect on Carotid Intima-media Thickening (CIMT)||1 year|Data were not collected when study was stopped prematurely.||||||
2730726|NCT01012414|Secondary|Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.||1 year|Data were not collected when study was stopped prematurely.||||||
2755462|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Baseline||||Percent||Standard Deviation|Mean
2730713|NCT01012622|Secondary|Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730714|NCT01012622|Secondary|Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730715|NCT01012622|Secondary|Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2730716|NCT01012622|Secondary|Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12|CHIP was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health.|Baseline and Week 12|"ITT population included participants who took study drug at least once and had primary efficacy endpoint data available. Last Observation Carried Forward (LOCF) method was used. n signifies participants who were evaluated for each specified category for this measure."|||units on a scale||Standard Deviation|Mean
2730717|NCT01012622|Primary|Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12|"Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) Very much improved or Much improved in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse, higher score indicates worsening of condition."|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||participants|||Number
2730718|NCT01012622|Primary|Number of Participants With Response Based on K-ARS Total Score at Week 12|Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||participants|||Number
2730719|NCT01012622|Primary|Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12|K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Baseline and Week 12|Intention-to-treat (ITT) population included participants who received the study drug at least once and had the primary efficacy endpoint data available|||units on a scale||Standard Deviation|Mean
2730720|NCT01012492|Secondary|Protective Immunity|Percent of CMV virus binding CD8+ t-cells at day +365 post-transplant|Day +365 post-transplant||||percentage of total CD8+ t-cells||Standard Error|Mean
2730721|NCT01012492|Secondary|Hematologic and Immunologic Reconstitution|Flow cytometric analysis of CD4 t-cell t-cell reconstitution was performed at day +100 post-transplant.|Day +100 post-transplant||||cell per microlitre||Standard Error|Mean
2730722|NCT01012492|Secondary|Percentage of Participants With Grades III-IV Acute GVHD at 2 Years|The rates of Grades III-IV acute GVHD were measured at 2 years according to standard Glucksberg criteria, which was 10%.|2 years after transplant||||percentage of participants|||Number
2730731|NCT01012362|Secondary|Number of Participants With Treatment-Related Adverse Events|Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.|Up to 30 days post treatment|Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.|||Participants|||Count of Participants
2730732|NCT01012362|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)|A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for >7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding >/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by >2 weeks due to incomplete hematologic recovery (absolute neutrophil count > 1.5 X 10^9/L or platelets >100 X 10^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).|Week 3 of each dose|6 participants were included at Dose Level 1 to confirm safety after escalation to Dose level 2, but are grouped with the original 3 participants enrolled at Dose Level 1.|||Participants|||Count of Participants
2730733|NCT01012362|Primary|The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination|The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.|Week 3 of each dose level||||Dose Level|||Number
2730734|NCT01012336|Secondary|Time to First Vomiting Episode or Use of Rescue Medication||120 hours|||||||
2730735|NCT01012336|Secondary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy||120 hours|||||||
2730736|NCT01012336|Primary|Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen||120 hours|||||||
2730737|NCT01012336|Primary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.|Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).|120 hours||||Percentage of Participants|||Number
2730738|NCT01012323|Secondary|Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study|The Quality of Life (QoL) questionnaire Short Form-36 Health Survey (SF-36-HS) was completed by participants ≥ 14 years of age. The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Units on a scale||Standard Deviation|Mean
2730739|NCT01012323|Secondary|Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study|The Quality of Life (QoL) questionnaire Child Health Questionnaire-Parent Form (CHQ-PF50) was completed by a parent or guardian in study participants < 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates more positive functioning or better health status. A positive change score indicates improvement.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Units on a scale||Standard Deviation|Mean
2730740|NCT01012323|Secondary|Percentage of Participants That Missed School or Work Due to an Infection||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Percentage of participants|||Number
2730741|NCT01012323|Secondary|Percentage of Participants With at Least 1 Episode of Fever||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Percentage of participants|||Number
2730742|NCT01012323|Secondary|Number of Participants Hospitalized Due to an Infection||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Participants|||Number
2730743|NCT01012323|Secondary|Number of Antibiotic Treatment Days Per Person-year of Treatment|The number of antibiotic treatment days per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment days / patient-years of NewGam treatment.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Treatment days/person/year|||Number
2730744|NCT01012323|Secondary|Number of Antibiotic Treatment Episodes Per Person-year of Treatment|The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of NewGam treatment.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Treatment episodes/person/year|||Number
2730822|NCT01012167|Secondary|Laboratory Measures - Bilirubin|Bilirubin blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730745|NCT01012323|Secondary|Percentage of Participants Treated With Antibiotics|The total percentage of participants treated with antibiotics, as well as, the percentage of participants treated with antibiotics therapeutically and prophylactically are reported.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Percentage of participants|||Number
2730746|NCT01012323|Secondary|Time to Resolution of Serious and Other Infections|Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Days||Standard Deviation|Mean
2730747|NCT01012323|Secondary|Number of Non-serious Infections|The MedDRA preferred term was used to determine the type of non-serious infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. The total number of infections and the number in each category are reported.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Infections|||Number
2730748|NCT01012323|Secondary|Total Number of Infections|The number of infections included serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) and other infections. For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Infections|||Number
2730749|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Varicella-zoster Virus|Trough level concentrations of antibodies against varicella-zoster virus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||U/mL||Standard Deviation|Mean
2730750|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Tetanus|Trough level concentrations of antibodies against tetanus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||IU/mL||Standard Deviation|Mean
2730751|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Cytomegalovirus|Trough level concentrations of antibodies against cytomegalovirus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||U||Standard Deviation|Mean
2730752|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae|Trough level concentrations of antibodies against Streptococcus pneumoniae (serotypes types 6B, 14, 9V, 18C, 19F, 4, and 23F) were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||µg/mL||Standard Deviation|Mean
2730753|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Measles|Trough level concentrations of antibodies against measles were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||mIU/mL||Standard Deviation|Mean
2730754|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Haemophilus Influenzae|Trough level concentrations of antibodies against Haemophilus influenzae were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||µg/mL||Standard Deviation|Mean
2730755|NCT01012323|Secondary|IgG Trough Level Concentration|Total IgG trough concentrations were measured in serum samples taken before each infusion.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||g/L||Standard Deviation|Mean
2730768|NCT01012245|Secondary|Visual Impairment Due to Glaucoma|Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups|||participants|||Number
2730756|NCT01012323|Primary|Number of Serious Bacterial Infections Per Person-year of Treatment|The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Serious infections per person-year of tr|||Number
2730757|NCT01012297|Secondary|Objective Response Rate as Measured by RECIST 1.1 Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 5 years|All randomized|||percentage of participants||95% Confidence Interval|Number
2730758|NCT01012297|Secondary|Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0|"Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse.~Please refer to the adverse event reporting for more detail."|Up to 5 years|All randomized.|||Participants|||Count of Participants
2730759|NCT01012297|Secondary|Overall Survival|"Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan.~The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group."|Up to 5 years|All randomized|||months||95% Confidence Interval|Median
2730760|NCT01012297|Primary|Progression-free Survival|"Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.~Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|All randomized|||months||95% Confidence Interval|Median
2730761|NCT01012258|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).|Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant|ITT population included all participants who received at least one dose of the IMP cetuximab or RT.|||months||95% Confidence Interval|Median
2730762|NCT01012258|Primary|Best Overall Response (BOR)|Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit|Intention-to-treat (ITT) population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or RT.|||percentage of participants||95% Confidence Interval|Number
2730763|NCT01012245|Secondary|Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment|Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.|Baseline up to 3 years|Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized.|||participants|||Number
2730764|NCT01012245|Secondary|Reasons for Discontinuation From Study|Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.|January 2000 through December 2008|Subjects from the All subjects group population who discontinued the study.|||participants|||Number
2730765|NCT01012245|Secondary|Investigator Assessment of Tolerability of Xalatan® Treatment|Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.|Baseline up to 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).|||participants|||Number
2730766|NCT01012245|Secondary|Reasons for Changes in Glaucoma Therapy|Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.|January 2000 through December 2008|"Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to other therapy (Other Medication) were not included in this analysis; not summarized by subgroups."|||participants|||Number
2730767|NCT01012245|Secondary|Subject Self-care: Application of Eye Drops|Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups|||participants|||Number
2730845|NCT01012167|Secondary|Vital Signs - Pulse|Mean sitting pulse (bpm) by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||bpm||Standard Deviation|Mean
2730769|NCT01012245|Secondary|Visual Acuity (Visus)|Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations|||participants|||Number
2730770|NCT01012245|Secondary|Subject Assessment of Satisfaction With Xalatan® Treatment|Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).|||participants|||Number
2730771|NCT01012245|Secondary|Investigator Assessment of Xalatan® Efficacy|Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit).|||participants|||Number
2730772|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.|||ratio||Standard Deviation|Mean
2730773|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.|||ratio||Standard Deviation|Mean
2730774|NCT01012245|Primary|Aulhorn Stage (Visual Field Defects)|Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations|||participants|||Number
2730775|NCT01012245|Primary|Change From Baseline in Intraocular Pressure (IOP)|Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).|Baseline, 1 year, 2 years, and 3 years|All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.|||mm Hg||Standard Deviation|Mean
2730776|NCT01012219|Primary|Cutaneous Bleeding Time (BT)|"Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.~The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.~Period 3 was not analyzed as bleeding time was not an objective for this part of the study."|Day 8|Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis.|||Seconds||95% Confidence Interval|Least Squares Mean
2730777|NCT01012167|Secondary|Willingness to Interact|"Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being definitely willing and 5 being definitely unwilling. The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
2730778|NCT01012167|Secondary|Reactions to Partner|"Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being completely agree and 5 being completely disagree. The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
2730779|NCT01012167|Secondary|Positive and Negative Affect Schedule (PANAS) - Positive|"Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
2730796|NCT01012167|Secondary|Side Effect Checklist (SEC) - Stiffness|"Percentage of participants with new onset or worsening compared to baseline of Stiffness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730780|NCT01012167|Secondary|Positive and Negative Affect Schedule (PANAS) - Negative|"Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
2730781|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Working Memory|MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730782|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Visual Learning|MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test—Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730783|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Verbal Learning|MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test—Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730784|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Social Cognition|MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730785|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving|MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730786|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Processing Speed|MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730787|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Attention Vigilance|"MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome.~."|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730788|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Composite Score|MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
2730789|NCT01012167|Secondary|Side Effect Checklist (SEC) - Wheezing|"Percentage of participants with new onset or worsening compared to baseline of Wheezing rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants with missing wheezing data."|||percentage of participants|||Number
2730790|NCT01012167|Secondary|Side Effect Checklist (SEC) - Weight Loss|"Percentage of participants with new onset or worsening compared to baseline of Weight Loss rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730791|NCT01012167|Secondary|Side Effect Checklist (SEC) - Vomiting|"Percentage of participants with new onset or worsening compared to baseline of Vomiting rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730792|NCT01012167|Secondary|Side Effect Checklist (SEC) - Uterine Contractions|"Percentage of participants with new onset or worsening compared to baseline of Uterine Contractions rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Female participants|||percentage of participants|||Number
2730793|NCT01012167|Secondary|Side Effect Checklist (SEC) - Urticaria|"Percentage of participants with new onset or worsening compared to baseline of Urticaria rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730794|NCT01012167|Secondary|Side Effect Checklist (SEC) - Tremor|"Percentage of participants with new onset or worsening compared to baseline of Tremor rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730795|NCT01012167|Secondary|Side Effect Checklist (SEC) - Tinnitus|"Percentage of participants with new onset or worsening compared to baseline of Tinnitus rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730798|NCT01012167|Secondary|Side Effect Checklist (SEC) - Sedation|"Percentage of participants with new onset or worsening compared to baseline of Sedation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730799|NCT01012167|Secondary|Side Effect Checklist (SEC) - Restlessness|"Percentage of participants with new onset or worsening compared to baseline of Restlessness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730800|NCT01012167|Secondary|Side Effect Checklist (SEC) - Rash|"Percentage of participants with new onset or worsening compared to baseline of Rash rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730801|NCT01012167|Secondary|Side Effect Checklist (SEC) - Nausea|"Percentage of participants with new onset or worsening compared to baseline of Nausea rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730802|NCT01012167|Secondary|Side Effect Checklist (SEC) - Nasal Irritation|"Percentage of participants with new onset or worsening compared to baseline of Nasal Irritation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing nasal irritation data."|||percentage of participants|||Number
2730803|NCT01012167|Secondary|Side Effect Checklist (SEC) - Mucosal Ulceration|"Percentage of participants with new onset or worsening compared to baseline of Mucosal Ulceration rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730804|NCT01012167|Secondary|Side Effect Checklist (SEC) - Malaise|"Percentage of participants with new onset or worsening compared to baseline of Malaise rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730805|NCT01012167|Secondary|Side Effect Checklist (SEC) - Insomnia|"Percentage of participants with new onset or worsening compared to baseline of Insomnia rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730806|NCT01012167|Secondary|Side Effect Checklist (SEC) - Hypersalivation|"Percentage of participants with new onset or worsening compared to baseline of Hypersalivation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730807|NCT01012167|Secondary|Side Effect Checklist (SEC) - Hyperhydrosis|"Percentage of participants with new onset or worsening compared to baseline of Hyperhydrosis rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing Hyperhydrosis data."|||percentage of participants|||Number
2730808|NCT01012167|Secondary|Side Effect Checklist (SEC) - Headache|"Percentage of participants with new onset or worsening compared to baseline of Headache rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730809|NCT01012167|Secondary|Side Effect Checklist (SEC) - Fever|"Percentage of participants with new onset or worsening compared to baseline of Fever rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730810|NCT01012167|Secondary|Side Effect Checklist (SEC) - Excessive Tearing of the Eye|"Percentage of participants with new onset or worsening compared to baseline of Excessive Tearing of the Eye rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing excessive tearing of the eye data."|||percentage of participants|||Number
2730811|NCT01012167|Secondary|Side Effect Checklist (SEC) - Enuresis|"Percentage of participants with new onset or worsening compared to baseline of Enuresis rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730812|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dry Mouth|"Percentage of participants with new onset or worsening compared to baseline of Dry Mouth rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730813|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dry Eye|"Percentage of participants with new onset or worsening compared to baseline of Dry Eye rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing dry eye data."|||percentage of participants|||Number
2730814|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dizziness|"Percentage of participants with new onset or worsening compared to baseline of Dizziness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730815|NCT01012167|Secondary|Side Effect Checklist (SEC) - Diarrhea|"Percentage of participants with new onset or worsening compared to baseline of Diarrhea rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730816|NCT01012167|Secondary|Side Effect Checklist (SEC) - Constipation|"Percentage of participants with new onset or worsening compared to baseline of Constipation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730817|NCT01012167|Secondary|Side Effect Checklist (SEC) - Bruising Easily|"Percentage of participants with new onset or worsening compared to baseline of Bruising Easily rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730818|NCT01012167|Secondary|Side Effect Checklist (SEC) - Anorexia|"Percentage of participants with new onset or worsening compared to baseline of Anorexia rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730819|NCT01012167|Secondary|Side Effect Checklist (SEC) - Abdominal Pain|"Percentage of participants with new onset or worsening compared to baseline of Abdominal Pain rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
2730823|NCT01012167|Secondary|Laboratory Measures - A/G Ratio|Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant date for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
2730824|NCT01012167|Secondary|Laboratory Measures - Globulin|Globulin blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
2730825|NCT01012167|Secondary|Laboratory Measures - Albumin|Albumin blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
2730826|NCT01012167|Secondary|Laboratory Measures - Glucose|Glucose blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730827|NCT01012167|Secondary|Laboratory Measures - VLDL|Very low density lipoprotein (VLDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730828|NCT01012167|Secondary|Laboratory Measures - Triglycerides|Triglyceride blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730829|NCT01012167|Secondary|Laboratory Measures - LDL|Low-density lipoprotein (LDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730830|NCT01012167|Secondary|Laboratory Measures - HDL|High-density lipoprotein (HDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data from Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730831|NCT01012167|Secondary|Laboratory Measures - Cholesterol|Total cholesterol blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730832|NCT01012167|Secondary|Laboratory Measures - CO2|Carbon Dioxide (CO2) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
2730833|NCT01012167|Secondary|Laboratory Measures - Chloride|Chloride blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
2730834|NCT01012167|Secondary|Laboratory Measures - Potassium|Potassium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
2730835|NCT01012167|Secondary|Laboratory Measures - Sodium|Sodium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
2730836|NCT01012167|Secondary|Laboratory Measures - Calcium|Calcium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
2730837|NCT01012167|Secondary|Laboratory Measures - Alkaline Phosphatase|Alkaline phosphatase blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation at Week 6.|||U/L||Standard Deviation|Mean
2730838|NCT01012167|Secondary|Laboratory Measures - AST/SGOT|Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||U/L||Standard Deviation|Mean
2730839|NCT01012167|Secondary|Laboratory Measures - ALT/SGPT|Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||U/L||Standard Deviation|Mean
2730840|NCT01012167|Secondary|Blood Oxytocin Levels|Blood Oxytocin Levels by Treatment and Visit|Treatment Week 0 and Week 6|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.|||pg/mL||Standard Deviation|Mean
2730841|NCT01012167|Secondary|Barnes Akathisia Scale (BAS) - Global Score|"For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from 0=Absent to 5=Severe Akathisia. Higher scores indicate a more severe global rating of akathisia."|Treatment Week 0 and Week 6|50 participants who completed the trial.|||percentage of participants|||Number
2730842|NCT01012167|Secondary|Electrocardiogram (EKG)|Mean corrected QT interval (QTc) by study week and treatment.|Once during Evaluation and once at Treatment Week 6|50 participants who completed the trial.|||QTc||Standard Deviation|Mean
2730843|NCT01012167|Secondary|Abnormal Involuntary Movement Scale (AIMS)|"AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from 0=None to 4=Severe. The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating."|Treatment Week 0 and Week 6|50 participants who completed the trial.|||percentage of participants|||Number
2730844|NCT01012167|Secondary|Simpson-Angus Scale (SAS)|"SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from 0=None/Normal to 4=Extreme/Severe. The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating."|Baseline, week 3, and week 6|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||percentage of participants|||Number
2730849|NCT01012167|Secondary|Arizona Sexual Experience Questionnaire (ASEX) Male|"Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences."|Once during evaluation and once at the end of 6 weeks of study treatment|Male participants who completed at least two weeks follow-up.|||units on a scale||Standard Deviation|Mean
2730850|NCT01012167|Secondary|Arizona Sexual Experience Questionnaire (ASEX) Female|"Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences."|Once during evaluation and once at the end of 6 weeks of study treatment|Female participants who completed at least two weeks follow-up.|||units on a scale||Standard Deviation|Mean
2730851|NCT01012167|Secondary|Calgary Depression Scale (CDS) - Total Score|"Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating."|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
2730852|NCT01012167|Secondary|Brief Psychiatric Rating Scale (BPRS) - Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Every other week for 6 weeks|Safety data available for the 56 participants exposed to study treatment.|||units on a scale||Standard Deviation|Mean
2730853|NCT01012167|Secondary|Brief Psychiatric Rating Scale (BPRS) - Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Every other week for 6 weeks|Safety data available for 56 participants exposed to study treatment.|||units on a scale||Standard Deviation|Mean
2730854|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
2730855|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Alogia|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
2730856|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
2730857|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Avolition|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
2730858|NCT01012167|Primary|Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week|* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.|Treatment Week 0 and Week 6|Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.|||units on a scale||Standard Deviation|Mean
2730859|NCT01012167|Primary|Scale for the Assessment of Negative Symptoms (SANS) Total Score|Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
2730860|NCT01012089|Primary|Drug Clearance Due to Dialysis (CLdialysis)|The rate at which a drug substance is removed from the body due to dialysis therapy|0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mL/hr||Full Range|Mean
2730861|NCT01012089|Primary|Total Drug Clearance (CLtotal)|The rate at which a drug substance is removed from the body|0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mL/hr||Full Range|Mean
2732867|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||0 weeks|||||||
2730862|NCT01012089|Primary|Elimination Rate Constant (Ke)||0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||hr-1||Full Range|Mean
2730863|NCT01012089|Primary|Volume of Distribution at Steady State (Vss)|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug|0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||L||Full Range|Mean
2730864|NCT01012089|Primary|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)||0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg∙hr/L||Full Range|Mean
2730865|NCT01012089|Primary|Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)||0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg∙hr/L||Full Range|Mean
2730866|NCT01012089|Primary|Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)||0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg∙hr/L||Full Range|Mean
2730867|NCT01012089|Primary|Maximum Plasma Concentration (Cmax)||0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg/L||Full Range|Mean
2730868|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 6.5%|||percentage of participants|||Number
2730869|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 7.0%|||percentage of participants|||Number
2730870|NCT01012037|Secondary|Percentage of Patients With Rescue Therapy|Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.|12 weeks||||percent|||Number
2730871|NCT01012037|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12|Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.|Week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Patients without a value at Week 12 were analysed as non-responders|||percent|||Number
2730872|NCT01012037|Secondary|FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.|||percent||Standard Error|Mean
2730873|NCT01012037|Secondary|FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.|||percent||Standard Error|Mean
2730874|NCT01012037|Secondary|FPG Change From Baseline at Week 12|Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Mean
2730875|NCT01012037|Secondary|HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.|||percent||Standard Error|Mean
2730876|NCT01012037|Secondary|HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 6 value were handled by the statistical model.|||percent||Standard Error|Mean
2730877|NCT01012037|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
2730928|NCT01011556|Secondary|Pharmacokinetics Parameters: Maximal Concentration (Cmax)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, 12 Months|Due to high intra-subject variability, zero participants were analyzed for this outcome measure.||||||
2730878|NCT01011946|Primary|Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer|"Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as normal or abnormal. Lymph Node (LN) sampling and histopathology determined true positives and true negatives."|PEM was performed prior to surgery and LN sampling immediately following surgery||||percentage of subjects||95% Confidence Interval|Number
2730879|NCT01011933|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry.|Study entry up to 2 years||||participants|||Number
2730880|NCT01011933|Other Pre-specified|Number of Participants Off Study Therapy for Each Reason Specified.||from study entry until end of study treatment, up to 5 years.||||participants|||Number
2730881|NCT01011933|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients|||months||Inter-Quartile Range|Median
2730882|NCT01011933|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for the first 6 months; then every 3 months thereafter for up to 5 years|Eligible and treated patients|||months||Inter-Quartile Range|Median
2730883|NCT01011933|Primary|Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0||Each cycle during treatment and 30 days after the last treatment.|Eligible and evaluable patients|||Participants|||Count of Participants
2730884|NCT01011933|Primary|Objective Tumor Response Rate Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at study entry, is required; Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry; Stable Disease is any condition not meeting the above criteria.|From study entry, assessed up to 5 years||||participants|||Number
2730885|NCT01011933|Primary|Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST)|"Number of participants who survived progression-free for more than 6 months.~Progression is defined using Response Evaluation Criteria for Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions in the opinion of the treating physician, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression."|> 6 months from study entry||||participants|||Number
2730886|NCT01011907|Secondary|Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.|Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.|Week 1 to Week 12||||Scores on a scale||Standard Error|Mean
2730887|NCT01011907|Secondary|Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.||Weeks 1-12||||drinks||Standard Error|Mean
2730888|NCT01011907|Primary|Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.||Weeks 1-12||||cigarettes||Standard Error|Mean
2730889|NCT01011894|Primary|Best Response|The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Complete Response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment), No constitutional symptoms, ANC >/= 1,500/ul, platelets> 100,000/ul, Hgb>11gm/dl (untransfused); Partial Response (PR): >50% decrease in peripheral blood lymphocyte count from the pre-treatment baseline value, reduction in lymphadenopathy, reduction in size of the liver and/or the spleen; Progressive Disease (PD): Characterized by at least one of the following: > 50% increase in the sum of the products of at least 2 lymph nodes on at least 2 consecutive exams at least 2 weeks apart. At least 1 node must be >/= to 2cm in size, Appearance of new palpable LN, > 50% increase in size of liver or spleen determined by measurement below the respective costal|2 years|20 participants had Stable Disease, 3 had Progression of Disease, 3 were not evaluable due to toxicity|||Participants|||Count of Participants
2730890|NCT01011868|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment|The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (NCF)|||participants|||Number
2730891|NCT01011868|Other Pre-specified|Confirmed Hypoglycemic Events|Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).|During the course of the study (82 weeks)|Treated set (TS). Treatment assignment as first medication taken.|||participants|||Number
2730892|NCT01011868|Secondary|Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment|Change from baseline in HbA1c after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|Week 54 - FAS (OC-78) Week 78 - FAS78-completers (LOCF-78)|||percentage of HbA1c||Standard Error|Mean
2730893|NCT01011868|Secondary|Change From Baseline in Body Weight at Follow-up|Change from baseline in body weight at follow up (82 weeks)|Baseline and 82 weeks|FAS-FU (OR)|||kg||Standard Deviation|Mean
2730895|NCT01011868|Secondary|Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment|Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|FAS (OC-78) for week 54 FAS78-completers (LOCF-78) for week 78 - Values after start of antidiabetic rescue therapy except changes in basal insulin dose were set to missing and last observation carried forward (LOCF) was used for imputation of missing values|||IU||Standard Error|Mean
2730896|NCT01011868|Secondary|Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (OC)|||percentage of Change from BL in FPG||Standard Error|Mean
2730897|NCT01011868|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS observed cases (OC)|||mg/dL||Standard Error|Mean
2730898|NCT01011868|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment|Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment|Baseline and 18, 54 and 78 weeks|FAS with non-completers considered failure (NCF)|||participants|||Number
2730899|NCT01011868|Primary|Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment|Baseline and 18 weeks|"FAS18-completers-included FAS patients not prematurely discontinue prior to Week 18, completed required minimum treatment duration, and had an on treatment HbA1c value within Week 18 time window. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF-18) was used for imputation.~(LOCF-18)"|||percentage of HbA1c||Standard Error|Mean
2730900|NCT01011829|Secondary|Retention (Completion)|Retention was determined by the proportion of participants retained for the entire trial and time until drop-out.|8-weeks|Intention to treat|||participants|||Number
2730901|NCT01011829|Primary|Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|8-weeks|Intention to treat|||total MA-free urine drug screens|Participants|Standard Deviation|Mean
2730902|NCT01011816|Secondary|Roland-Morris Disability Questionnaire Score|"Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score~The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject's back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability."|26-weeks|All subjects assigned as success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).|||percentage of subjects|||Number
2730903|NCT01011816|Secondary|Visual Analog Scale for Low Back Pain|"Percent of subjects achieving a minimum 30% decrease in pain from baseline.~The visual analog scale is a horizontal 100 mm line anchored on the left with the words No Pain and on the right with the words Worst Possible Pain. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject's level of low back pain experienced over the last week."|26-weeks|All subjects assigned success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).|||percentage of subjects|||Number
2730904|NCT01011816|Primary|Subject Composite Success|Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.|26 weeks|All subjects adjudicated as a success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).|||percentage of subjects|||Number
2730905|NCT01011738|Secondary|Number of Deaths During Observation Period|The clinical endpoint of deaths due to any cause during observation period is presented.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of peginterferon alfa-2a and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
2730906|NCT01011738|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
2730907|NCT01011738|Secondary|Number of Participants With Non-Serious Adverse Drug Reactions|Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
2730929|NCT01011556|Secondary|Pharmacokinetics Parameters: Area Under the Curve (AUC)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, and 12 Months|Due to high intra-subject variability, zero participants were analyzed on this outcome measure.||||||
2760003|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|up to 44 weeks||||inches||Standard Deviation|Mean
2730908|NCT01011738|Secondary|Number of Participants With Serious Adverse Drug Reactions|"A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect."|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
2730909|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis|Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Participants|||Number
2730910|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation|Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Participants|||Number
2730911|NCT01011738|Secondary|Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status|ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Ratio||Standard Deviation|Mean
2730912|NCT01011738|Secondary|Percentage of Participants With Normalization of Alanine Transaminase|A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730913|NCT01011738|Secondary|Quantitative Hepatitis B Surface Antigen|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Log10 IU/mL||Standard Deviation|Mean
2730914|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion|Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) 'POSITIVE' or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730915|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants|The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730916|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants|"A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA ≥ 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered.~Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730917|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants|A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730918|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants|"HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) 'POSITIVE' or (ii) a quantitative result considered 'positive' in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL.~Abbreviations for pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730919|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants|The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2730920|NCT01011738|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
2730921|NCT01011738|Primary|Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance|"Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) 'Negative' or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis as observed)."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2730922|NCT01011673|Secondary|Satisfaction Scores|"24 hours after the emergency department visit, patients were asked, The next time you come to the Er with this type of headache, do you want to receive the same medication? Affirmative answers are tabulated here."|24 hours|3 patients in each group were lost to follow-up. All others are tabulated here.|||participants|||Number
2730923|NCT01011673|Primary|Change in Pain Score|At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score|Baseline, 60 minutes|3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized.|||units on a scale||Standard Deviation|Mean
2730924|NCT01011634|Primary|Pain Score Within 5 Mins After Procedure||within 5 mins after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.||||||
2730925|NCT01011634|Secondary|Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration||30 min after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.||||||
2730926|NCT01011556|Secondary|DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up|Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.|||participants|||Number
2730927|NCT01011556|Secondary|DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up|Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.|||participants|||Number
2730930|NCT01011556|Secondary|Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels|Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).|Baseline and 1, 3, 12, and 13 Months (mon)|All randomized participants who received at least one dose of study drug and had antibody results.|||participants|||Number
2730931|NCT01011556|Secondary|Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).||Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.|||beats per minute (bpm)||Standard Deviation|Mean
2730932|NCT01011556|Secondary|Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.|Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.|||mmHg||Standard Deviation|Mean
2730933|NCT01011556|Secondary|Change From Baseline in Urine Calcium Excretion at 6 and 12 Months||Baseline, 6 Months, 12 Months|All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.|||millimole/day (mmol/day)||Standard Deviation|Mean
2730934|NCT01011556|Secondary|Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours|Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).|Baseline, 12 Months|All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2730935|NCT01011556|Secondary|Convenience/Ease of Use Questionnaire (CEUQ)|CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.|baseline up to 12 months|All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.|||participants|||Number
2730936|NCT01011556|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.|||percentage change in P1CP||Standard Deviation|Median
2730937|NCT01011556|Secondary|Percent Change From Baseline of C-Terminal Telopeptide (CTX)|C-terminal telopeptide is a marker of bone resorption.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.|||percentage change in CTX||Standard Deviation|Mean
2730938|NCT01011556|Secondary|Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.|||percentage change in P1NP||Standard Deviation|Mean
2730939|NCT01011556|Secondary|Time Course Change of BMD Response at the Lumbar Spine|To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).|Baseline to 6 Months and 12 Months|All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.|||percentage change in BMD||90% Confidence Interval|Least Squares Mean
2730940|NCT01011556|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|Baseline, 6 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.|||percentage change in BMD||90% Confidence Interval|Least Squares Mean
2730941|NCT01011556|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.|Baseline, 12 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.|||percentage change in BMD||90% Confidence Interval|Least Squares Mean
2730951|NCT01011439|Primary|Progression-free Survival Rate at 3 Months|The proportion of successes (i.e. patients alive and progression free at 3 months since treatment start) out of the total number of evaluable patients|3 months since treatment start|"Evaluable patients: population consisting of all treated patients who fulfill the following conditions:~histological confirmation of thymic carcinoma by an Independent Review Committee~received at least 80% of drug in the first two cycles overall~baseline and >/= 1 on treatment tumor assessment or die before tumor re-assessment"|||Participants|||Count of Participants
2730952|NCT01011413|Secondary|Steady-state Efavirenz Concentrations|Steady-state efavirenz mid-dosing interval plasma concentrations|Week 4|Available data analysis|||milligram per Litre||90% Confidence Interval|Geometric Mean
2730942|NCT01011465|Primary|Speech Threat and Challenge|Measure of threat and challenge calculated from observation of non-verbal behavioral cues during stress exposure. Threat (negative reaction) results when an individual does not feel that he or she has sufficient resources to complete a task or manage a difficult situation. Its reverse, challenge (positive reaction), occurs when an individual perceives that he or she has sufficient resources. Independent observers used videotapes of behavior during the stress tasks and rated participants on 7 point scales for 11 challenge-related behaviors (comfortable, confident, enthusiastic, clear, alert, high level of eye contact, etc), and for 8 threat-related behaviors (agitation, rigid posture, speech disfluency, etc). Challenge scores were averaged, and threat scores averaged then reverse-scored. The mean of challenge and reversed threat scores comprise the score used here. Range: 1.1 to 6.1, with higher scores representing more challenge orientation and reflecting a better outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom speech threat score was calculated, were included|||units on a scale||Standard Deviation|Mean
2730943|NCT01011465|Primary|Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure).|Based on 20-item Positive and Negative Affect Schedule (PANAS) which comprises two mood scales, positive affect and negative affect. Each item is rated on a 5-point scale ranging from (1 = very slightly or not at all) to (5 = extremely) to indicate how the respondent felt at the moment the question was asked. Here, we've used the negative affect sub-scale which consists of the sum of the 10 negative affect items, with a possible range of 10 (least negative affect) to 50 (most negative affect). This score was measured at baseline (study range: 10 to 29) and directly before stress exposure (study range: 10 to 37), and the reported value is the difference between these two scores (range of differences: -13 to 26). It estimates negative affect due to anticipatory stress. The value is the difference between the pre-stress measure and baseline measure, therefore a larger number for the difference means a bigger increase in negative affect due to anticipatory stress, and is a worse outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom negative affect score was calculated, were included|||units on a scale||Standard Deviation|Mean
2730944|NCT01011465|Primary|Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure|Systolic blood pressure (SBP)is connected with reaction to exposure to stress. Systolic blood pressure is collected at baseline and after nasal spray administration/directly before stress tasks; it represents anticipatory stress reaction. This measure represents the difference between baseline and pre-task systolic blood pressure values. A greater difference score represents an increase from baseline in systolic blood pressure during the pre-task, and so a larger difference score represents higher reactivity. A lower difference score, or negative difference score, indicates a lower increase, or even decrease, from baseline in systolic blood pressure during the pre-task and reflects less reactivity. Reactivity is associated with increased risk of developing hypertension. Range of baseline/pre-count differences in SBP: -11 to 37.7|within 2 hours of treatment|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom systolic blood pressure was collected, were included|||mm Hg||Standard Deviation|Mean
2730945|NCT01011439|Secondary|Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters)|"The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment.~Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities was evaluated by considering the worst occurrence for each patient throughout the whole treatment period."|Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles.|All treated patients|||Participants|||Count of Participants
2730946|NCT01011439|Secondary|Overall Survival|The length of time from the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still alive.|Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.|Evaluable patients|||Months||95% Confidence Interval|Median
2730947|NCT01011439|Secondary|Duration of Response|Assessed in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.|Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.||||Months||95% Confidence Interval|Median
2730948|NCT01011439|Secondary|Progression-free Survival|The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.|Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.|Evaluable patients|||Months||95% Confidence Interval|Median
2730949|NCT01011439|Secondary|Disease Control Rate|Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD>/= 6 weeks). The analysis was performed in the evaluable populations.|Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.|Evaluable patients|||Percentage of patients||95% Confidence Interval|Number
2730950|NCT01011439|Secondary|Confirmed Objective Response Rate (ORR)|Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1) The analysis was performed in the evaluable population.|Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.|Evaluable patients|||Percentage of patients||95% Confidence Interval|Number
2730953|NCT01011413|Secondary|Change From Baseline in Estimate Creatinine Clearance|Change from baseline to week 96 in estimate creatinine clearance between randomised treatment arms|Baseline and 2 years|Available data analysis|||millilitres per minute||95% Confidence Interval|Mean
2732868|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||0 weeks|||||||
2730954|NCT01011413|Secondary|Change in Selected Serum Biochemical Parameters|Change from baseline to week 96 in alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase levels between randomised treatment arms|Baseline and 2 years|Available data analysis|||Units per Litre||95% Confidence Interval|Mean
2730955|NCT01011413|Secondary|Change From Baseline in Fasted Insulin Levels|Change from baseline to week 96 in fasted insulin levels|Baseline and 2 years|Available data analysis|||mU per litre||95% Confidence Interval|Mean
2730956|NCT01011413|Secondary|Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications|AIDS Clinical Trials Group (ACTG) 7-day adherence questionnaire scores. Maximum value is all pills taken every day; minimum value is no pills taken per day. Higher scores indicate a better outcome.|2 years|Number of participants attending week 96 visit|||Participants|||Count of Participants
2730957|NCT01011413|Secondary|Change From Baseline in Metabolic Endpoints|Change from baseline to week 96 in fasted total cholesterol, high density cholesterol and low density cholesterol, and glucose between randomised treatment arms|Baseline and 2 years|Available data analysis|||mmol per Litre||95% Confidence Interval|Mean
2730958|NCT01011413|Secondary|Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality|Number of participants in each randomised arm diagnosed with a serious non-AIDS defining event, who die from an AIDS-defining event, who die from a non-AIDS-defining event|up to 2 years|modified ITT population|||Participants|||Count of Participants
2730959|NCT01011413|Secondary|Mean Change From Baseline in CD4+ T-cell Count|Mean change from baseline to week 96 in CD4+ T-cell count/mm3 between the two treatment arms|Baseline and 2 years|modified ITT (all participants who received at least one dose of study treatment and attended at least one follow up visit, irrespective of treatment received)|||cells per mm3||95% Confidence Interval|Mean
2730960|NCT01011413|Secondary|Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL and <50 Copies/mL at 48 and 96 Weeks After Randomisation|Percentage of participants in each of the two treatment arms with plasma HIV-1 RNA <400 copies/mL and <50 copies/mL at 48 and 96 weeks after randomisation|Baseline and 2 years|Modified ITT including all randomised participants who took at least one dose of study medication and attended at least one follow-up visit|||participants|||Number
2730961|NCT01011413|Primary|Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation|Percentage of participants in each of the treatment arms with centrally quantified plasma HIV-1 RNA viral load <200 copies/mL 48 weeks after randomisation.|48 weeks|modified intention to treat including all randomised patients who took at least one dose of study medication AND attended at least one follow-up visit.|||percentage of participants||95% Confidence Interval|Number
2730962|NCT01011387|Primary|Mean Change in Wound Area.|Measured by tracing of wound and measured by planimeter.|From baseline to maximum 4 weeks||||cm2||Full Range|Mean
2730963|NCT01011335|Primary|Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population|Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold.|Up to 3 months||||μg/mL||95% Confidence Interval|Geometric Mean
2730964|NCT01011335|Primary|Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports|Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary|Up to 6 months||||events|||Number
2730965|NCT01011309|Secondary|IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)|Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.|Days 0, 56 or 84, and 168|Per-protocol population: patients who received all three study injections (immunotherapy groups) or at least 15 SSG injections (chemotherapy group) and completed the Day 84 or Day 56 visit.|||Relative ELISA Units||Full Range|Median
2730966|NCT01011309|Primary|Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.|Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.|Day 0 through Day 84|Safety population: All patients who received at least one study injection.|||participants|||Number
2730967|NCT01011309|Primary|Date of Clinical Cure|Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.|Day 84|Per-protocol population: All patients who received all three study injections if in the immunotherapy groups or at least 15 injections of SSG if in the chemotherapy group, and completed the Day 56 visit (Immunotherapy v1.6), the Day 84 visit (Immunotherapy v1.4/1.5), or the Day 56 or Day 84 visit (Chemotherapy group).|||participants|||Number
2730968|NCT01011283|Secondary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.~Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|36 Weeks|Intent to Treat Population|||Percentage of Participants|||Number
2731408|NCT01008449|Secondary|Subject Satisfaction With Comfort With Scar|Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort|at end of follow-up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
2730969|NCT01011283|Primary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.~Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|13 Weeks|Intent to Treat Population|||Percentage of Participants|||Number
2730970|NCT01011218|Other Pre-specified|Brief Fatigue Inventory (BFI)|"The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers (No fatigue to As bad as you can imagine), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue.~The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation."|up to 32 Weeks|After baseline, it was not uncommon for participants to not contribute data for every time point.|||units on a scale||Standard Deviation|Mean
2730971|NCT01011218|Other Pre-specified|The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|"The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.~The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation."|up to 32 Weeks|After baseline, it was not uncommon for participants to not contribute data for every time point.|||units on a scale||Standard Deviation|Mean
2730972|NCT01011218|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.~The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation."|up to 32 Weeks|After baseline, it was not uncommon for participants to not contribute data for every time point.|||units on a scale||Standard Deviation|Mean
2730973|NCT01011218|Primary|Insomnia Severity Index (ISI)|"Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows.~0 to 7 No clinically significant insomnia~8 to14 Subthreshold insomnia~15 to 21 Clinical insomnia (moderate severity)~22 to 28 Clinical insomnia (severe)~ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation."|up to 32 Weeks|After baseline, it was not uncommon for participants to not contribute data for every time point.|||units on a scale||Standard Deviation|Mean
2730974|NCT01011179|Secondary|Stress (Perceived Stress Questionnaire; PSQ)||Baseline (prior to randomization) and 3 months after intervention|||||||
2730975|NCT01011179|Secondary|Adherence to Treatment (Child Adherence Report Questionnaire; CARQ)||Baseline (prior to randomization) and 3 months after intervention|||||||
2730976|NCT01011179|Secondary|Self-efficacy (Children's Arthritis Self-Efficacy Scale; CASE)||Baseline (prior to randomization) and 3 months after intervention|||||||
2730977|NCT01011179|Secondary|Pain Coping (Pain Coping Questionnaire)||Baseline (prior to randomization) and 3 months after intervention|||||||
2730978|NCT01011179|Secondary|Disease Specific Knowledge (Medical Issues, Exercise, Pain and Social Support Questionnaire; MEPS)||Baseline (prior to randomization) and 3 months after intervention|||||||
2730979|NCT01011179|Primary|Juvenile Arthritis Quality of Life Questionnaire (JAQQ)|The questionnaire is divided into 4 dimensions: gross motor function, fine motor function, psychosocial function, and general symptoms. A 7-point ordinal scale is used to rate responses to each item from 1 (none of the time) to 7 (all of the time), based on how often the item was a problem for the child over the past 2 weeks. Total score was composed of the 4 dimension scores (top 5 items of that dimension) divided by 4, with higher scores denoting poorer HRQOL.|Baseline (prior to randomization) and 3 months after intervention||||units on a scale||Standard Deviation|Mean
2730980|NCT01011153|Secondary|To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.|For each case reviewed, physicians were asked if they thought the lesion was a melanoma (diagnostic sensitivity/specificity) and whether or not they would biopsy or refer the lesion (biopsy/referral sensitivity/specificity. These measurements were compared using areas under the corresponding receiver operating characteristic curves. (see statistical analysis for results) ROC curves (reciver operating curves) are plotted on graphs with an x-axis of sensitivity and a y-axis of 1-specificity.|June 2010||||Area Under Curve for biopsy/referral||Standard Deviation|Geometric Mean
2730981|NCT01011153|Secondary|Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.|Each physician was given up to 130 cases and asked whether or not they would biopsy the lesion. Interobserver variability was measured via the kappa statistic indicating how well the physicians' answers to that question agreed within each group. Kappa statistics are reported in the statistical analysis. while numbers rep, they dont reflect the sgreement among the subjects|December 2009|The statistical analysis section contains the Kappa results within Each of the Caregiver Groups|||Number of Cases|||Number
2739108|NCT00957359|Secondary|Death Anxiety Scale|0-15 (higher score more death anxiety)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2730982|NCT01011153|Secondary|Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of each group of physicians to that of Melafind, which is presented in the statistical analysis.|December 2009|Each category was diminished after excluded subjects were taken into account. These included subjects who did not complete at least 78 cases, subjects who previously participated in other EOS studies, pediatricians, and a board eligible dermatologist.|||Proportion of True Cases||95% Confidence Interval|Mean
2730983|NCT01011153|Primary|Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.|April 2010|Participants were invited to enroll in this study via mail. Minimum number of participants was determined by statistician based on power analyses and number of cases completed. The time frame of the study was about 6 months and the comparison between Dermatologists and MelaFind is presented in the statistical analysis section below.|||Proportion of True Cases||95% Confidence Interval|Mean
2730984|NCT01011075|Secondary|Toxicities|Adverse events of grade 3 or higher, according to CTCAE version 3|12 months|All enrolled and treated patients were evaluated for grade 3 or higher toxicities.|||Number of events|||Number
2730985|NCT01011075|Secondary|Progression Free Survival|Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)|12 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.|||Months||95% Confidence Interval|Median
2730986|NCT01011075|Secondary|Overall Survival|Overall survival as measured by the Kaplan-Meier method|12 Months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.|||Months||95% Confidence Interval|Median
2730987|NCT01011075|Primary|Response Rate|Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.|6 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.|||Percentage of Participants||95% Confidence Interval|Number
2730988|NCT01011049|Secondary|Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per protocol population.|||Percentage of Participants|||Number
2730989|NCT01011049|Secondary|Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
2730990|NCT01011049|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2730991|NCT01011049|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
2730992|NCT01010984|Secondary|Percentage of Tumor Response|Progression is determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Progressive disease is defined as at least 20% increase in the sum of the longest target lesions, taking as reference the smallest sum longest diameter recorded since start of treatment OR appearance of one or more new lesions greater then 1cm in size. Percentage of tumor response will be assessed up to 1 year post treatment.|Percentage of tumor response assessed up to 1 year post treatment.|Those who receive at least one dose of LC bead with doxorubin.|||percentage of tumor response||95% Confidence Interval|Median
2730993|NCT01010984|Primary|Incidence of Adverse Events|Adverse events were collected from all 20 subjects.|Date of surgery through 2 years post procedure or until patient death|Participants who received at least one dose of LC beads with doxorubin.|||Events|||Number
2730994|NCT01010971|Secondary|Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.|Week 0-2||||Days||Standard Error|Least Squares Mean
2731022|NCT01010932|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2-42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.|||percentage of stenotic segments|Participants|95% Confidence Interval|Number
2730995|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In Impaired Subjects with Baseline RQLQ(S) Score of ≥3.0|||units on a scale||Standard Error|Least Squares Mean
2730996|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
2730997|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0|||participants||Standard Error|Least Squares Mean
2730998|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0|||participants||Standard Error|Least Squares Mean
2730999|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731000|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731001|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731002|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731003|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731023|NCT01010932|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).|2 - 28 days|For 2 patients, MRA images were not analyzed because images were incomplete.|||percentage of arterial segments|Participants|95% Confidence Interval|Number
2739109|NCT00957359|Secondary|Hopelessness|0-16 (higher score more hopeless)|Baseline||||score on a scale||Standard Error|Mean
2731004|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731005|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731006|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731007|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731008|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731009|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731010|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731011|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731012|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
2731057|NCT01010763|Secondary|Radiographic Assessment|number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)|5 year|45 patients in M2a Magnum group and 36 patients in M2a Taper group were failed to be assessed radiographically at 5 year follow-up visit.|||Participants|||Count of Participants
2731013|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731014|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731015|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731016|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731017|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731018|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731019|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2731020|NCT01010971|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
2731021|NCT01010932|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2 - 42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.|||percentage of non-stenotic segments|Participants|95% Confidence Interval|Number
2731409|NCT01008449|Secondary|Subject Reported Satisfaction With Appearance of Scar|Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance|4 - 6 weeks post delivery||||units on a scale||Inter-Quartile Range|Median
2731024|NCT01010906|Secondary|Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug.|||µM||95% Confidence Interval|Geometric Mean
2731025|NCT01010906|Primary|Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.|||µM.hr||95% Confidence Interval|Geometric Mean
2731026|NCT01010867|Secondary|Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum||Up to Day +100 of HSCT||||Number of GVHD events|||Number
2731027|NCT01010867|Secondary|Number of Non-lactobacillus Infections|To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.|36 days (day -7 to +28 of HSCT)||||Number of non-lactobacillus infections|||Number
2731028|NCT01010867|Secondary|Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses|To determine the feasibility of administration of L. plantarum 299 and 299v. The treatment is considered feasible for a patient if he/she received at least 50% of the probiotic dose (>= 11 days of treatment).|22 days (day -7 to +14 of HSCT)||||percentage of prescribed doses||Full Range|Median
2731029|NCT01010867|Primary|Number of Lactobacillus Plantarum Bacteremia Infections||36 days (day -7 to +28 of HSCT)|Children and adolescents undergoing hematopoietic stem cell transplantation (HSCT)|||Number of infections||95% Confidence Interval|Number
2731030|NCT01010854|Secondary|Clinical Response Based on Tumor Measurement||after 4 cycles of therapy||||Participants|||Count of Participants
2731031|NCT01010854|Primary|Pathologic Response at Definitive Surgery||after 4 cycles of therapy||||Participants|||Count of Participants
2731032|NCT01010776|Other Pre-specified|Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13, 26, 39 and 52|The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731033|NCT01010776|Other Pre-specified|Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13 and 26|The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731034|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2731035|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2739110|NCT00957359|Secondary|Death Transcendence Scale|0-60 (higher score more death transcendence)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2731036|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase|Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of participants|||Number
2731037|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction - Main Phase|Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of Participants|||Number
2731038|NCT01010776|Secondary|Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Week 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Participants|||Number
2731039|NCT01010776|Secondary|Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Participants|||Number
2731040|NCT01010776|Secondary|Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731041|NCT01010776|Secondary|Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731042|NCT01010776|Secondary|Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731043|NCT01010776|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731056|NCT01010763|Secondary|Harris Hip Score|"Harris Hip Score is physician assessing hip functional scoring system, which includes 4 components (pain, function, deformity and range of motion) with minimum score of 0 & maximum score of 100.~Maximum & Minimum score of each subscale is pain: 0-44, function: 0-47, Deformity: 0-4 and Range of motion: 0-5.~Current report uses summed score of each patient to compare total Harris Hip Score.~Higher score means better outcomes."|5 year|68 patients in M2a Magnum group and 62 patients in M2a Taper group were failed to obtain Harris Hip Score data at 5 year follow-up visit.|||units on a scale||Full Range|Mean
2731044|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731045|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase|The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731046|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.|||Percentage of participants||95% Confidence Interval|Number
2731047|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.|||Percentage of participants||95% Confidence Interval|Number
2731048|NCT01010776|Primary|Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.|||Units on a scale||Standard Deviation|Mean
2731049|NCT01010776|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 26|The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
2731050|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|5 year|33 patients in M2a Magnum group and 30 patients in M2a Taper group were failed to obtain Metal Ion data at 5 year follow-up visit.|||microgram/Litter||Full Range|Mean
2731051|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|4 year|50 patients in M2a Magnum group and 46 patients in M2a Taper group were failed to obtain Metal Ion data at 4 year follow-up visit.|||microgram/Litter||Full Range|Mean
2731052|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|3 year|21 patients in M2a Magnum group and 19 patients in M2a Taper group were failed to obtain Metal Ion data at 3 year follow-up visit.|||microgram/Litter||Full Range|Mean
2731053|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|2 year|12 patients in M2a Magnum group and 10 patients in M2a Taper group were failed to obtain Metal Ion data at 2 year follow-up visit.|||microgram/Litter||Full Range|Mean
2731054|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|1 year|7 patients in M2a Magnum group and 9 patients in M2a Taper group were failed to obtain Metal Ion data at 1 year follow-up visit.|||microgram/Litter||Full Range|Mean
2731055|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|6 month|4 patients in M2a Taper group were failed to obtain Metal Ion data at 6 month follow-up visit.|||microgram/Litter||Full Range|Mean
2739111|NCT00957359|Secondary|Death Anxiety Scale|0-15 (higher score more death anxiety)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2731058|NCT01010763|Secondary|UCLA Activity Score|"UCLA is physician assessing scoring system to assess patient's activity level. Minimum score is 0 (completely inactive) and maximum score is 9 (Regularly participates in impact sports) with 1 point increments depending on patient's activity level.~Higher score means higher activity level achieved."|5 year|59 patients in M2a Magnum group and 59 patients in M2a Taper group were failed to obtain UCLA Activity Score data at 5 year follow-up visit.|||units on a scale||Full Range|Mean
2731059|NCT01010763|Secondary|Metal Ion|Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.|3 month|3 patients in M2a Taper group were failed to obtain Metal Ion data at 3 month follow-up visit.|||microgram/Litter||Full Range|Mean
2731060|NCT01010763|Primary|Range of Motion|Hip Flexion Angle at 1 year postoperatively|1 year|2 patients in M2a Magnum group and 4 patients in M2a Taper group were failed to obtain Range of Motion data at 1 year follow-up visit.|||degrees||Full Range|Mean
2731061|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index|Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
2731062|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Problems With Self-Concept|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
2731063|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
2731064|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
2731065|NCT01010750|Secondary|Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
2731066|NCT01010750|Primary|Power of Attention Score|The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.|pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7|The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||milliseconds||Standard Error|Mean
2731067|NCT01010633|Primary|Grade 0 Pain|Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.|Visit 5 (Postoperative Day 8)|Intent to treat population (ITT)|||Eyes|Participants||Number
2731068|NCT01010633|Secondary|Resolution of Anterior Chamber Cells.|Study eyes with complete resolution of anterior chamber cells (ACC)|At visits 4-7- postoperative day 3, 8,15 & 18||||Eyes|||Number
2731069|NCT01010633|Primary|Resolution of Anterior Chamber Cells (ACC).|Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.|Visit 5 (Postoperative day 8)|Intent to treat (ITT) population|||Eyes|Participants||Number
2731070|NCT01010568|Secondary|Median PFS|Kaplan Meyer PFS|2 years||||months||95% Confidence Interval|Median
2731071|NCT01010568|Secondary|Complete Response Rate|NCI IWG response criteria|6 months||||participants|||Number
2731072|NCT01010568|Primary|Overall Response Rate|40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia|6 months||||participants|||Number
2731073|NCT01010555|Primary|On-eye Wettability|On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
2731074|NCT01010503|Secondary|Short Form-36 (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.|Weeks 0, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2731106|NCT01010230|Primary|Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in g/cm^2||Standard Deviation|Mean
2739112|NCT00957359|Secondary|Death Anxiety Scale|0-15 (higher score more death anxiety)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2731075|NCT01010503|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2731076|NCT01010503|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase protein. Levels of CRP increase with inflammation.|Weeks 0, 4, 12, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
2731077|NCT01010503|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Weeks 0, 4, 12, 20, and 24|TT population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2731078|NCT01010503|Secondary|Tender Joint Count (TJC)|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
2731079|NCT01010503|Secondary|Swollen Joint Count (SJC)|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
2731080|NCT01010503|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2731081|NCT01010503|Secondary|Patient Global Assessment of Disease Activity|The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2731082|NCT01010503|Secondary|Patient Global Assessment of Pain|Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2731083|NCT01010503|Primary|Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg||Weeks 0, 4, 8, 12, 16, and 20|ITT Population|||percentage of participants|||Number
2731084|NCT01010503|Primary|Percentage of Participants Withdrawing From the Study Prematurely for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2731085|NCT01010503|Primary|Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2731086|NCT01010503|Primary|Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2731087|NCT01010503|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Weeks 0, 4, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2731088|NCT01010503|Primary|Percentage of Participants Adherent to Original Treatment|Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.|Week 24|Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug|||percentage of participants|||Number
2731089|NCT01010477|Primary|The Number of Subjects Who Quit Smoking From Weeks 5 to 8|Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.|4 weeks||||participants|||Number
2731090|NCT01010399|Secondary|Proportion of Subjects With HIV-1 RNA <50 Copies/mL||24 weeks||||participants|||Number
2731091|NCT01010399|Primary|Proportion of Subjects With Triglycerides <200 mg/dL||24 weeks||||participants|||Number
2731410|NCT01008449|Secondary|Post Operative Pain - 72 - 96 Hours Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|72 - 96 hours post delivery||||units on a scale||Inter-Quartile Range|Median
2731092|NCT01010282|Secondary|Change From Baseline in Conjunctival Staining Severity Score at Day 90|Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
2731093|NCT01010282|Secondary|Change From Baseline in Corneal Staining at Day 90|Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
2731094|NCT01010282|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Day 90|Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Seconds||Standard Deviation|Mean
2731095|NCT01010282|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90|Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
2731096|NCT01010282|Primary|Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90|Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
2731097|NCT01010230|Secondary|Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups|"Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index.~Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||ratio of RANKL/OPG||Standard Deviation|Mean
2731098|NCT01010230|Secondary|Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of 10 nmol BCE/L||Standard Deviation|Mean
2731099|NCT01010230|Secondary|Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of µg/l||Standard Deviation|Mean
2731100|NCT01010230|Secondary|Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of µg/L||Standard Deviation|Mean
2731101|NCT01010230|Secondary|Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of ng/mL||Standard Deviation|Mean
2731102|NCT01010230|Primary|Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in mg/cm^4||Standard Deviation|Mean
2731103|NCT01010230|Primary|Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in mg/cc||Standard Deviation|Mean
2731104|NCT01010230|Primary|Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in mg/cc||Standard Deviation|Mean
2731105|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in g/cm^2||Standard Deviation|Mean
2731107|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after start of intervention/|This was an intent to treat analysis.|||% change in grams/cm||Standard Deviation|Mean
2731108|NCT01010230|Secondary|Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of µg/L||Standard Deviation|Mean
2731109|NCT01010230|Primary|Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after start of intervention|This was an intent to treat analysis.|||% change in grams/cm||Standard Deviation|Mean
2731110|NCT01010217|Secondary|Disease Free Survival|Participants who have survived without their original disease.|1 year|Second Transplant and Myelofibrosis was not evaluated due to low accrual.|||Participants|||Count of Participants
2731111|NCT01010217|Secondary|cGVHD|Chronic graft vs host disease|1 year|Second Transplant and Myelofibrosis was not evaluated due to low accrual.|||Participants|||Count of Participants
2731112|NCT01010217|Secondary|Grade III-IV aGVHD|Acute Graft vs host disease|100 days|Second Transplant and Myelofibrosis was not evaluated due to low accrual|||Participants|||Count of Participants
2731113|NCT01010217|Secondary|Engraftments||Day 28|Second Transplant and Myelofibrosis was not evaluated due to low accrual.|||Participants|||Count of Participants
2731114|NCT01010217|Secondary|Number of Participants With Non Related Mortality (NRM)|Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease.|six months|Second Transplant and Myelofibrosis was not evaluated due to low accrual.|||Participants|||Count of Participants
2731115|NCT01010217|Primary|Number of Participants With Non-relapse Mortality (NRM)|Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease. Bayesian monitoring scheme described in Thall, Simon, and Estey (1996) employed to perform interim monitoring of the data during the course of the trial separately within each group.|At 100 days|Second Transplant and Myelofibrosis was not evaluated due to low accrual.|||Participants|||Count of Participants
2731116|NCT01010204|Secondary|Participants Experiencing Neuropsychiatric Events|Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder.|24 weeks|Bipolar Patients|||Participants|||Count of Participants
2731117|NCT01010204|Primary|7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence|24 weeks|bipolar patients|||participants|||Number
2731118|NCT01010204|Primary|7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks|12 weeks|bipolar subjects|||participants|||Number
2731119|NCT01010126|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from study entry to the date patients end treatment.Time to treatment failure will be evaluated using the method of Kaplan-Meier.|Time from study entry to the date patients end treatment, assessed up to 3 years|All patients that began study treatment were included in this analysis.|||months||95% Confidence Interval|Median
2731120|NCT01010126|Secondary|Time to Disease Progression|Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.|Time from registration to disease progression, assessed up to 3 years|All patients that began protocol treatment and were evaluated for response are included in this analysis.|||months||95% Confidence Interval|Median
2731121|NCT01010126|Secondary|Overall Survival|Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.|Time from registration to death, assessed up to 3 years|All patients that received study intervention and were followed for survival were included in this analysis.|||months||95% Confidence Interval|Median
2731122|NCT01010126|Secondary|Incidence of Adverse Events|Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.|Every cycle of treatment, up to 3 years|All patients that received protocol treatment and were evaluated for adverse events are reported in this analysis.|||Participants|||Count of Participants
2731123|NCT01010126|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.|Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years|All patients that were assessed as a Complete Response or Partial Response were included in this analysis.|||months||95% Confidence Interval|Median
2731176|NCT01009814|Secondary|AUC (0-24) of BMS-626529 Following QHS Dosing|Blood samples were collected at indicated time points to assess AUC (0-24) of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.|Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731124|NCT01010126|Primary|Tumor Response Rate|Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to <1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort.|Up to 3 years|For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response.|||proportion of participants||95% Confidence Interval|Number
2731125|NCT01010126|Primary|Progression Free Survival Rate|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval).|6 months|All patients that received study treatment and were evaluated for response are included in this analysis|||proportion of patients||95% Confidence Interval|Number
2731126|NCT01010061|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.|||unit on a scale||Standard Deviation|Mean
2731127|NCT01010061|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score|The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.|||unit on a scale||Standard Deviation|Mean
2731128|NCT01010061|Secondary|Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)|Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).|Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)|PK population includes all participants with PK data available at the given time-point.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2731129|NCT01010061|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.|||Months||95% Confidence Interval|Median
2731130|NCT01010061|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
2731131|NCT01010061|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.|||Months||95% Confidence Interval|Median
2731132|NCT01010061|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.|||Months||95% Confidence Interval|Median
2731133|NCT01010061|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.|||Months||95% Confidence Interval|Median
2731134|NCT01010061|Secondary|Percentage of Participants With Best Overall Response|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
2731135|NCT01010061|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
2731136|NCT01010061|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)|Intent-to-treat population included all randomized participants. Participants without PFS events were censored.|||Percentage of participants|||Number
2731137|NCT01010061|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||Months||95% Confidence Interval|Median
2731138|NCT01010061|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2731139|NCT01010061|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||Months||95% Confidence Interval|Median
2731140|NCT01010009|Primary|Modulation of Deoxygenated Levels of Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.|||µmol/L||Standard Error|Mean
2731141|NCT01010009|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.|46-81 mins post dose|Cognitive performance data was analysed for all subjects who completed the trial. If data was not utilized in the final analysis then this was either due to technical issues (i.e. the computer did not save data) or it was clear that the participant had not engaged with the task/s.|||Participants|||Number
2731142|NCT01010009|Primary|Modulation of Levels of Total Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.|||µmol/L||Standard Error|Mean
2731143|NCT01009983|Secondary|Expression of EGFR and Other Protein Markers||baseline|Test not completed as specified in protocol that will only be completed if a full sample was accrued.||||||
2731144|NCT01009983|Secondary|Survival||Approximately 7 months||||months||95% Confidence Interval|Median
2731145|NCT01009983|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Approximately 7 months||||months||95% Confidence Interval|Median
2731146|NCT01009983|Primary|Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria|Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.|every 28 days for a minimum of 84 days||||participants|||Number
2731147|NCT01009931|Secondary|Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression|Cycle 1 of treatment|48 months|The study participant died before the study data collection completed.||||||
2731148|NCT01009931|Primary|Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%||43 months|The study participant died before the study data collection completed.||||||
2731149|NCT01009931|Primary|Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)||42 months|The study participant died before the study data collection completed.||||||
2731150|NCT01009840|Secondary|Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria|The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin > 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) > 5% weight gain, or (3) ascites.|6 Months|Safety population included all participants who received IV busulfan.|||Percentage of participants|||Number
2731151|NCT01009840|Secondary|Percentage of Participants With Transplant-Related Mortality|The percentage of participants with death related to transplant.|6 Months|Safety population included all participants who received IV busulfan.|||Percentage of participants|||Number
2731152|NCT01009840|Secondary|Percent Difference Between Area Under Curve (AUC) and Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percent difference||Full Range|Median
2731153|NCT01009840|Secondary|Ratio Area Under Curve (AUC)/Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Ratio||Full Range|Median
2731154|NCT01009840|Secondary|Percent Change in IV Busulfan Dose|The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day −5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percent change||Full Range|Median
2731155|NCT01009840|Secondary|Percentage of Participants With Progression-free Survival Events|Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percentage of participants|||Number
2731167|NCT01009814|Secondary|Ctrough of Ritonavir Following Q12H Dosing|Blood samples were collected at indicated time points to access Ctrough of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8, Day 8 morning dose (AM) and Day 8 evening dose (PM).|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Days 5,6,7: pre-morning dose|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2731411|NCT01008449|Secondary|Post Operative Pain - 4 - 6 Weeks Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|at end of follow-up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
2731156|NCT01009840|Secondary|Progression-free Survival|Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Days||95% Confidence Interval|Median
2731157|NCT01009840|Secondary|Percentage of Participants With Overall Survival Events|Overall Survival Event was death.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percentage of participants|||Number
2731158|NCT01009840|Secondary|Overall Survival|Overall Survival was defined as the time in days from transplantation to death due to all causes.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Days||95% Confidence Interval|Median
2731159|NCT01009840|Primary|Percentage of Participants With Overall Disease Response at Month 6|The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: [stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow], [Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow], [Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level <100 mg/24 hour], [Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to <200 mg per 24 hour], [Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease] or [Progressive Disease (PD)].|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percentage of participants|||Number
2731160|NCT01009814|Secondary|Accumulation Index of Ritonavir Following QHS Dosing|Blood samples were collected at indicated time points to assess Accumulation Index of ritonavir following QHS dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 evening dose (PM).|Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population. Only those participants with data available at the specified time points were analyzed.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2731161|NCT01009814|Secondary|Accumulation Index of Ritonavir Following Q12H Dosing|Blood samples were collected at indicated time points to assess Accumulation Index of ritonavir following Q12H dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 morning dose (AM).|Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2731162|NCT01009814|Secondary|AUC (0-24) of Ritonavir Following QHS Dosing|Blood samples were collected at indicated time points to assess AUC (0-24) of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.|Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731163|NCT01009814|Secondary|AUC (0-24) of Ritonavir Following Q12H Dosing|Blood samples were collected at indicated time points to assess AUC (0-24) of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.|Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed.|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731164|NCT01009814|Secondary|AUC (Tau) of Ritonavir Following QHS Dosing|Blood samples were collected at indicated time points to assess AUC (tau) of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1 and Day 8 evening dose (PM).|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731165|NCT01009814|Secondary|AUC (Tau) of Ritonavir Following Q12H Dosing|Blood samples were collected at indicated time points to assess AUC (tau) of ritonavir following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM) and Day 8 evening dose (PM).|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731166|NCT01009814|Secondary|Ctrough of Ritonavir Following QHS Dosing|Blood samples were collected at indicated time points to assess Ctrough of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8 and Day 8 evening dose (PM).|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2731168|NCT01009814|Secondary|Cmax of Ritonavir Following QHS Dosing|Blood samples were collected at indicated time points to assess Cmax of ritonavir following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 evening dose (PM) and Day 8 morning (AM) + evening dose (PM).|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2731169|NCT01009814|Secondary|Cmax of Ritonavir Following Q12H Dosing|Blood samples were collected at indicated time points to assess Cmax of ritonavir following Q12H dosing. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM), Day 8 evening dose (PM) and Day 8 morning + evening dose (AM+PM). Pharmacokinetic parameter values were derived by non-compartmental methods. PK Population was used which comprised of all participants who receive ritonavir and provided pharmacokinetic samples.|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2731170|NCT01009814|Secondary|Inhibitory Quotient of BMS-626529 by Ctrough Following QHS Dosing|Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measure was used in evaluating IQ: Ctrough. Geometric mean and geometric coefficient of variation are presented.|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 2: pre-evening dose, 12,16 hours; Day 9: pre-dose, 12,16 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-evening dose|PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2731171|NCT01009814|Secondary|Inhibitory Quotient of BMS-626529 by Ctrough Following Q12H Dosing|Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measure was used in evaluating IQ: Ctrough. Geometric mean and geometric coefficient of variation are presented.|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Day 9: pre-dose, 4,12 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-morning dose|PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2731172|NCT01009814|Secondary|Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following QHS Dosing|Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measures were used in evaluating IQ: Cmin and Css,avg. Geometric mean and geometric coefficient of variation are presented.|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Day 2: pre-evening dose, 12,16 hours; Day 9: pre-dose, 12,16 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-evening dose|PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2731173|NCT01009814|Secondary|Inhibitory Quotient (IQ) of BMS-626529 by Css,Avg and by Lowest Concentration of a Drug During Dosing Interval (Cmin) Following Q12H Dosing|Blood samples were collected at indicated time points to assess IQ of BMS-626529. Inhibitory quotient was calculated as the ratio of BMS-626529 in vivo exposure to in vitro measured protein binding adjusted EC90 (PBA-EC90). The following in vivo exposure measures were used in evaluating IQ: Cmin and Css,avg. Geometric mean and geometric coefficient of variation are presented.|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Day 9: pre-dose, 4,12 hours; Day 10: pre-dose, 12 hours; Day 11: pre-dose; Days 5,6,7: pre-morning dose|PK Population. Only those participants with data available at the specified time points were analyzed. No evidence of a correlation between changes in viral load from Baseline (on Day 9 or the nadir) and the BMS-626529 PK parameters was found. Log10 PBA EC90 and IQs of Cmin and Css,avg were found to correlate with antiviral activity.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2731174|NCT01009814|Secondary|Accumulation Index of BMS-626529 Following QHS Dosing|Blood samples were collected at indicated time points to assess Accumulation Index of BMS-626529 following QHS dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 evening dose (PM).|Day 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population. Only those participants with data available at the specified time points were analyzed.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2731175|NCT01009814|Secondary|Accumulation Index (AI) of BMS-626529 Following Q12H Dosing|Blood samples were collected at indicated time points to assess Accumulation Index of BMS-626529 following Q12H dosing. AI was calculated as ratio of AUC(tau) at steady-state to AUC(tau) after the first dose. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8 morning dose (AM).|Day 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2731412|NCT01008449|Secondary|Operative Procedure Time.|time for procedure as measured in minutes|Intraoperative, at time of intervention.||||minutes||Inter-Quartile Range|Median
2739113|NCT00957359|Primary|HADS Depression|Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2731177|NCT01009814|Secondary|Area Under the Concentration-time Curve Over a 24-hour Period (AUC [0-24]) of BMS-626529 Following Q12H Dosing|Blood samples were collected at indicated time points to assess AUC (0-24) of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 8.|Day 8: pre-morning dose, 1,2,3,4,5,6,8,12, 13,14,15,16,17,18,20 hours|PK Population|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731178|NCT01009814|Secondary|AUC (Tau) of BMS-626529 Following QHS Dosing|Blood samples were collected at indicated time points to assess AUC (tau) of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1 and Day 8 evening dose (PM).|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731179|NCT01009814|Secondary|Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-626529 Following Q12H Dosing|Blood samples were collected at indicated time points to assess AUC (tau) of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (AM) and Day 8 evening dose (PM).|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2731180|NCT01009814|Secondary|Ctrough of BMS-626529 Following QHS Dosing|Blood samples were collected at indicated time points to assess Ctrough of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8 and Day 8 evening dose (PM).|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours; Days 5,6,7: pre-evening dose|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2731181|NCT01009814|Secondary|Trough Observed Plasma Concentration (Ctrough) of BMS-626529 Following Q12H Dosing|Blood samples were collected at indicated time points to access Ctrough of BMS-626529 following Q12H dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Days 5, 6, 7, 8, Day 8 morning dose (AM) and Day 8 evening dose (PM).|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours; Days 5,6,7: pre-morning dose|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2731182|NCT01009814|Secondary|Cmax of BMS-626529 Following QHS Dosing|Blood samples were collected at indicated time points to assess Cmax of BMS-626529 following QHS dosing. Pharmacokinetic parameter values were derived by non-compartmental methods. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 evening dose (PM) and Day 8 morning (AM) + evening dose (PM).|Days 1, 8: pre-evening dose, 1,2,3,4,5,6,8 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2731183|NCT01009814|Secondary|Maximum Observed Plasma Concentration (Cmax) of BMS-626529 Following Q12H Dosing|Blood samples were collected at indicated time points to assess Cmax of BMS-626529 following Q12H dosing. Geometric mean and geometric coefficient of variation are presented for Day 1, Day 8 morning dose (Anti Meridiem [AM]), Day 8 evening dose (Post Meridiem [PM]) and Day 8 morning + evening dose (AM+PM). Pharmacokinetic parameter values were derived by non-compartmental methods. Pharmacokinetic (PK) Population was used which comprised of all participants who receive BMS-663068 and provided pharmacokinetic samples.|Days 1, 8: pre-morning dose, 1,2,3,4,5,6,8,12 hours; Day 8: 13,14,15,16,17,18,20 hours|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2731184|NCT01009814|Secondary|Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters|Laboratory parameters included hematology, clinical chemistry and urine parameters. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented.|Up to 50 days|Safety Population|||Participants|||Count of Participants
2731185|NCT01009814|Secondary|Number of Participants With Worst-case Abnormalities in Electrocardiogram (ECG) Parameters|A 12-lead ECG was recorded during the study using an ECG machine that automatically measures ECG parameters. Normal range for ECG parameters were: PR interval (upper: 200 milliseconds [ms]); QRS (lower: 50 ms; upper: 120 ms); Corrected QT interval by Bazett formula (QTcB) (change from Baseline - increases by > 30 ms); Corrected QT interval by Fredericia formula (QTcF) (change from Baseline - increases by > 30 ms). Number of participants with worst-case abnormalities are presented which was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.|Up to 50 days|Safety Population|||Participants|||Count of Participants
2731206|NCT01009580|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2731186|NCT01009814|Secondary|Number of Participants With Worst-case Abnormalities in Body Temperature, Respiratory Rate [RR], and Heart Rate [HR]|Vital signs (body temperature, RR, and HR) were recorded. Normal range were: For HR, lower limit: 55 beats per minute (bpm) and change <-15 bpm; upper limit: >100 bpm and change >30 bpm). For temperature, lower limit: 36.0 Celsius; upper limit: >37.5 Celsius or change >1.7 Celsius). For RR, lower limit: 8 breaths per minute; upper limit: >16 breaths per minute or change >10 breaths per minute. Number of participants with worst-case abnormalities are presented. Worst-case abnormality was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. (3) Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.|Up to 50 days|Safety Population|||Participants|||Count of Participants
2731187|NCT01009814|Secondary|Number of Participants With Worst-case Abnormalities in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Vital signs including DBP and SBP were recorded. Normal ranges were as following: For DBP, lower limit: value <55 millimeter of mercury (mmHg) and change <-20 mmHg; upper limit: value >90 mmHg and change >20 mmHg). For SBP, lower limit: value <90 mmHg and change <-10 mmHg; upper limit: value >140 mmHg and change >10 mmHg. Number of participants with worst-case abnormalities are presented. Worst-case abnormality was defined as: (1) Below Normal: at least one post-Baseline assessment was below normal range, and no post-Baseline assessment was above normal range. (2) Above Normal: at least one post-Baseline assessment was above normal range, and no post-Baseline assessment was below normal range. (3) Within Normal: all post-Baseline assessments were within normal range. It was to be considered as 'Missing' when there were no post-Baseline assessments.|Up to 50 days|Safety Population|||Participants|||Count of Participants
2731188|NCT01009814|Secondary|Number of Participants With Any Abnormality in Physical Examination|A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. A brief physical examination included, at a minimum assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Any abnormality found by investigator during physical examination were recorded. Number of participants with any abnormality in physical examination during study have been reported.|Up to 50 days|Safety Population|||Participants|||Count of Participants
2731189|NCT01009814|Secondary|Number of Participants With Treatment Emergent Non-serious Adverse Event (Non-SAE) and Serious AE (SAE)|An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Treatment emergent adverse events (occurred after start of treatment) have been presented.Safety Population comprised of all randomized participants who used the trial medication at least once.|Up to 50 days|Safety Population|||Participants|||Count of Participants
2731190|NCT01009814|Secondary|Change From Baseline in Percent CD4+ Cell Count and Percent CD8+ Cell Count|Blood samples were collected for evaluation of percent CD4+ and percent CD8+ cells at Baseline (Day 1, pre-dose), Day 8, Day 15 (Follow up) and Day 50 (study discharge). Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline visit value from post-Baseline visit value.|Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50|Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percent cells per microliter||Standard Error|Mean
2731191|NCT01009814|Secondary|Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count and Cluster of Differentiation 8 Positive (CD8+) Cell Count|Blood samples were collected for evaluation of CD4+ and CD8+ cells at Baseline (Day 1, pre-dose), Day 8, Day 15 (Follow up) and Day 50 (study discharge). Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value.|Baseline (Day 1 pre-dose), Day 8, Day 15 and Day 50|Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per microliter (cells/μL)||Standard Error|Mean
2731192|NCT01009814|Primary|Mean Logarithm With Base 10 (Log10) Change From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Day 9|The primary assessment of the antiviral activity of BMS-663068 was assessed on the log10 change from Baseline in HIV RNA to Day 9. Baseline was the last non-missing observation before first dose (Day 1 pre-dose) and change from Baseline was calculated by subtracting Baseline value from post-Baseline visit value. An analysis of covariance (ANCOVA) model correcting for Baseline HIV viral load and treatment group was used to test the differences in mean log10 decrease in HIV RNA at Day 9 between 2 regimen groups by antiretroviral treatment history (ARV [antiretroviral] naive, ARV experienced, and combined [ARV naive + ARV experienced]). For the combined group (ARV naive +ARV experienced) an additional ANCOVA was used correcting also for treatment history as an additional covariate. Only Clade B participants were included in the population.|Baseline and Day 9|Pharmacodynamic Population. It comprised of all participants for whom pharmacodynamic measurements were available at Baseline and at least one other time.|||Log10 copies per milliliter (c/mL)||Standard Error|Mean
2731193|NCT01009762|Secondary|Numbers of Participants With Lowering of HIV RNA Viral-load|"HIV-1 RNA Viral load was measured by Quantitative-PCR in plasma as numbers of virus RNA copies/mm^3 relative to baseline viral-load for each participant. The numbers of participant with lowering of HIV RNA plasma Viral-load is counted at base-line and at 6 months (end of study) and provided in the table (analysis population description) and the number of participants that showed lowering of viral-load was counted.~Criteria for this anticipated end-point was a significant lowering of HIV RNA viral-load in >50% of responders (defined as participants with new T-cell responses)."|up to 6 months after treatment stop|the numbers of participants that showed changes (lowering of) in Viral load (measured as HIV-1 RNA copies/mm^3 plasma in commercial quantitative PCR) at end of study (6 months after vaccination) relative to base-line viral-load was counted at 6 month after vaccination (end of study)|||participants|||Number
2731194|NCT01009762|Secondary|Number of Participants With New T Cell Response to the Vaccine Target Epitopes|"Number of Participants with New T Cell Response to the Vaccine Target Epitopes as Measured by Intracellular Cytokine Stain Flowcytometry (IC-FACS) and/or IFNg-ELISPOT Analysis.~Criteria's for meeting anticipated secondary end-point was that >50% of vaccinees reacted with new Clusters of differentiation 8 (CD8) T-cell and/or Clusters of differentiation 4 (CD4) T-cell response to al least one of the vaccine target epitopes as measured by IC-Facs and/or interferon-gamma (IFNg) - Enzyme-Linked ImmunoSpot (ELISPOT) assays."|10-14 days or 3 months or 6 months after last immunisation|Peripheral Blood Mononuclear Cells (PBMC) from blood was measured in IFNg-ELISPOT and/or Intracellular Cytokines (ICS) Flowcytometry for T cell responses. All 10 vaccinee developed a new T cell immune response to at least one vaccine epitope. The saline placebo did not develop any new t cell responses.|||participants|||Number
2731195|NCT01009762|Primary|Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More)|the numbers of treatment related side effects (DLT = reaction 3 or more) are registered for participants|up to 6 months after end of treatment|Interview, questionaire, objective examination by medical doctor, blood testing for hematology, clinical chemistry, CD4 counts, HIV-1 viral load|||side effects|||Number
2731196|NCT01009645|Secondary|Recall Accuracy|"Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been presented as a fact, presented as a myth, presented, but I don't recall if it was a fact or a myth, or not presented. Participants scored 1 for each correct answer; 0 for each incorrect answer or for response I don't recall. Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are units on a scale to represent participant scores out of 8 on the recall items."|1 week following receipt of message||||units on a scale||Standard Deviation|Mean
2731197|NCT01009645|Primary|Influenza Vaccination|The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.|1 week following randomization||||participants|||Number
2731198|NCT01009619|Secondary|Plasma C-reactive Protein (CRP) Levels|Plasma C-reactive protein (CRP) levels were assessed using Tina-quant CRP latex assay, Roche, Mannheim, Germany; sensitivity threshold of 1 mg/L, upper limit of normal 5 mg/L.|during the first two years post-transplant||||mg/L||Standard Deviation|Mean
2731199|NCT01009619|Secondary|Broncho-alveolar (BAL) Neutrophilia|BAL was performed with two 50 mL aliquots of sterile saline at room temperature. Five mL of the recovered BAL fluid was sent for microbiological and virological assessment, whereas the remaining fluid was analysed for cell counts after a cytospin was made in a Shandon cytocentrifuge and stained with May-Grünwald-Giemsa. Differential cell counts were determined by counting at least 300 cells.|during first two years post-transplant||||percent cells||Standard Deviation|Mean
2731200|NCT01009619|Secondary|Pulmonary Function|Spirometry (Masterscreen, Jaeger, Hoechberg, Germany) was performed at twice weekly intervals for the first 2 postoperative months, thereafter at weekly to biweekly intervals until 6 months post-transplantation, then every 2 to 4 weeks until the first postoperative year and afterwards life-long at intervals of 2 to 3 months according to American Thoracic Society standards and forced expiratory volume in one second (FEV1) expressed in terms of the percentage of predicted values.|during first two years post-transplant||||percent predicted||Standard Deviation|Mean
2731201|NCT01009619|Secondary|Infection Incidence Rate|Cytomegalovirus (CMV)-status was assessed on on every broncho-alevolar lavage sample and by serum CMV DNA at weekly intervals during hospitalization and thereafter at each outpatient evaluation or hospital admission. Immunohistochemical staining for CMV was performed on transbronchial biopsies in case of clinical suspicion of infection (i.e. dyspnea, cough, sputum, fever, increased plasma C-reactive protein, new chest radiograph infiltrates, or a decrease of at least 10% in peak expiratory flow (PEF) as measured by patient's peak flow measurements.|2 years post-transplant|intention to treat|||incidence rate (events/person per year)||Standard Deviation|Mean
2731202|NCT01009619|Secondary|Acute Rejection Incidence Rate|Bronchoscopy and broncho-alveolar lavage (BAL) was routinely performed at discharge, 3, 6, 12, 18, 24 months post-transplantation and later at intervals of 1 year, or in case of clinically suspected acute allograft rejection, infection or chronic rejection. Transbronchial biopsies were routinely performed at discharge and 3 months post-transplant or in case of suspected acute rejection, infection or chronic rejection. Biopsies were graded according to the 1996 ISHLT-guidelines (grade A0-4 with concomitant B0-4), as well as assessed for other interstitial lesions of the pulmonary graft.|2 years post-transplant||||incidence rate (events/person per year)||Standard Deviation|Mean
2731203|NCT01009619|Primary|Overall Survival|Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.|2 years post-transplant|intention to treat|||participants|||Number
2731204|NCT01009619|Primary|Prevalence of Bronchiolitis Obliterans Syndrome (BOS)|BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.|2 years post-transplant|intention to treat analysis|||participants|||Number
2731205|NCT01009580|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2731207|NCT01009580|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS. For 24 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2731208|NCT01009580|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2731209|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731210|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731211|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731212|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731213|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731214|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731446|NCT01008150|Primary|Pathologic Complete Response in Breast and Axillary Lymph Nodes.|Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy|At time of surgery, approximately 7 months||||Participants|||Count of Participants
2731215|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731216|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731217|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731218|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731219|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731220|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731358|NCT01008696|Secondary|Overall Assessment of Study Medication by Investigator|Investigator's overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad.|Day 57|The FAS included participants who received the study medication at least once and had follow-up data that could be used after the Baseline among the participants meeting the eligibility criteria of this study. LOCF was used. Here, 'N'=participants evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2731221|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731222|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731223|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731224|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731225|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731226|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731290|NCT01009138|Secondary|Health-care Costs: Medication Intake|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU||||number of daily medications/half year||Standard Deviation|Mean
2731227|NCT01009554|Secondary|Mean Stain Area for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731228|NCT01009554|Secondary|Mean Stain Area for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731229|NCT01009554|Secondary|Mean Stain Area for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731230|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731231|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731232|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731233|NCT01009554|Secondary|Mean Stain Score for Body Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731291|NCT01009138|Secondary|Health-care Costs: Non-productive Time|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU||||number of days on sick leave/half year||Standard Deviation|Mean
2731234|NCT01009554|Secondary|Mean Stain Score for Body Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731235|NCT01009554|Secondary|Mean Stain Score for Body Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731236|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731237|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731238|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731239|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731240|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731268|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731241|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731242|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731243|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731244|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731245|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731246|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731247|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731447|NCT01008059|Primary|Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity|AUC(0-inf)|9 hours||||(hr*ng/ml/mg)||Standard Deviation|Mean
2767521|NCT00757588|Secondary|Change From Baseline in Fasting Plasma Glucose Values||Baseline to Week 24||||mg/dL||Standard Error|Mean
2731248|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731249|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731250|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731251|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731252|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731253|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731254|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731458|NCT01007838|Secondary|Muscle Strength|Bilateral knee extensor isometric strength.|Change from baseline in muscle strength at 12 weeks|||||||
2731255|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731256|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731257|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731258|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731259|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731260|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731269|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731261|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731262|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731263|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731264|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731265|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731266|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731267|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731288|NCT01009203|Secondary|Toxicity Profile|Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.|3 years|Participants who received t least one dose of on-study treatment|||participants|||Number
2731270|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731271|NCT01009554|Primary|Oral Tissue Tolerance|Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.|through 8 weeks|Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.|||percentage of participants|||Number
2731272|NCT01009554|Primary|Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2731273|NCT01009515|Secondary|Time to Progression|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|The 16 patients who completed treatment were evaluable for progression-free survival.|||weeks||95% Confidence Interval|Median
2731274|NCT01009515|Secondary|Safety Profile|All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.|Up to 30 days after last on-study treatment, for up to 2 years|All patients who had received at least one dose of on-study treatment were evaluable for toxicity.|||participants|||Number
2731275|NCT01009515|Secondary|Overall Survival|The time from treatment initiation to death by any cause.|2 years|The 16 patients who completed treatment were evaluable for survival analysis.|||weeks||95% Confidence Interval|Median
2731276|NCT01009515|Primary|Objective Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.|6 months|The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.|||participants|||Number
2731277|NCT01009463|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2731289|NCT01009203|Primary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.|3 years||||Months||Full Range|Median
2731310|NCT01009060|Secondary|Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern|Samples for urinalysis were collected on Days 1, 7, 14, 21, 28, 35, 42, 49 and up to Day 59 (follow-up) to assess specific gravity, pH, glucose, protein, blood and ketone by dipstick and microscopic examination (if blood or protein is abnormal).|Up to Day 59|Safety Population.|||Participants|||Count of Participants
2731278|NCT01009463|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2731279|NCT01009463|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population|||Participants|||Number
2731280|NCT01009463|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2731281|NCT01009346|Secondary|Progression Free Survival (PFS) of RAD001 in Combination With Weekly Cetuximab and Cisplatin.|Median number of months for which participants are free of progression after initiating treatment with RAD001 in combination with weekly cetuximab and cisplatin.|2 years|Only 5 patients received at least one cycle of RAD001|||months||95% Confidence Interval|Median
2731282|NCT01009346|Primary|Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin.|MTD will be defined as a) the dose of RAD001 producing DLT in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 10mg po qd with less than 33% rate of DLT|6 months|Patients who received at least one cycle of RAD001 were included in the analysis.|||mg|||Number
2731283|NCT01009333|Secondary|Number of Pads Per Day|In a diary, subjects are asked to provide number of pads they used per day.|three weeks||||Pads Per Day||Standard Deviation|Mean
2731284|NCT01009333|Secondary|Number of Voids Per Day|In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.|||Voids Per Day||Standard Deviation|Mean
2731285|NCT01009333|Primary|Number of Urinary Incontinent Episodes Per Day|In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.|||Episodes Per Day||Standard Deviation|Mean
2731286|NCT01009203|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|3 years||||months||Full Range|Median
2731287|NCT01009203|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses|3 years|Participants evaluable for response|||percentage of evaluable participants|||Number
2740298|NCT00949988|Secondary|To Assess Duration of Progression-free Survival||5 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2731292|NCT01009138|Secondary|Health-care Costs: Health-care Utilisation|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU||||number of medical appointment/half year||Standard Deviation|Mean
2731293|NCT01009138|Secondary|Inflammatory Marker Hs-CRP|The inflammatory marker high sensitivity C-reactive protein (hs-CRP) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU||||mg/dl||95% Confidence Interval|Mean
2731294|NCT01009138|Secondary|Inflammatory Marker IL-1Ra|The inflammatory marker Interleukin 1 receptor antagonist (IL-1Ra) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU||||pg/ml||95% Confidence Interval|Mean
2731295|NCT01009138|Secondary|Inflammatory Marker IL-6|The inflammatory marker Interleukin 6 (IL-6) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU||||pg/ml||95% Confidence Interval|Mean
2731296|NCT01009138|Secondary|Glycemic Control (HbA1c)|The HbA1c was used as measure of glycemic control. All blood samples were analysed in a central laboratory using the Bio-Rad II Turbo analyser; the measurement units were %-points. Based on the measurement at baseline and 12-month follow up, the difference of the HbA1c values between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||%-points||Standard Deviation|Mean
2731297|NCT01009138|Secondary|Diabetes Acceptance (AADQ Score)|The Acceptance and Action Diabetes Questionnaire (AADQ) was used to assessment of diabetes acceptance. Using 11 items on diabetes-related experiential avoidance behaviours and a 5-point Likert response scale (1 - 5), the AADQ estimates the overall level of diabetes acceptance. Item scores are summed to a total score between 11 and 55 with higehr scores indicating better acceptance. Based on the measurement of diabetes acceptance at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
2731298|NCT01009138|Secondary|Diabetes Self-Care (SDSCA Score)|The Summary of Diabetes Self-Care Activities Measure (SDSCA) was used to assess diabetes self-care. The SDSCA assesses the number of days of the previous week (0 - 7) on which several specific self-care activities (appropriate diet, physical activity, self-monitoring of blood glucose, foot care) were performed. The item scores are summed and averaged to a total score from 0 to 7 with higher scores indicating better overall self-care. Based on the measurement of diabetes self-care at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
2731299|NCT01009138|Secondary|Diabetes-specific Distress (PAID Score)|The Problem areas in Diabetes Scale (PAID) was used to assess diabetes-specific distress. The PAID assesses diabetes-specific distress using 20 items and a five-point Likert scale (0 - 4). Item scores are summed and transformed to a range from 0 - 100 with higher scores indicating higher distress. Based on the measurement of diabetes-specific distress at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
2731300|NCT01009138|Secondary|Quality of Life (EQ-5D TTO Score)|The EuroQol Five Dimension Questionnaire (EQ-5D) was used to assess health-related quality of life (HRQOL). The EQ-5D assesses five dimensions of HRQOL using a 3-point scale. The item scores are weighted based on population data and used to calculate a standardised total score from 0 to 1 with higher scores indicating better HRQOL. Based on the measurement of HRQOL at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline,12 month FU||||Scores on a scale||Standard Deviation|Mean
2731301|NCT01009138|Primary|Depressive Symptoms (CES-D Score)|The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive symptoms. The CES-D assesses the frequency of 20 typical symptoms of depression during the previous week on a 4-point Likert scale. Summing of the item scores estimates the total score with a range between 0 and 60 and higher scores indicating more severe depressive mood. Based on the measurement of depressive symptoms at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
2731302|NCT01009099|Primary|Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)|The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.|baseline and 12 weeks|Patients who completed 12 weeks of exercise training were analyzed. There was one patient in each group that did not complete the treadmill test at 12 weeks although they completed other secondary outcome measures. Although they did not complete this measure, they remained in the study and were not counted as a drop.|||minutes||Standard Deviation|Mean
2731311|NCT01009060|Secondary|Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment|Clinical chemistry parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Creatinine, Direct Bilirubin, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Sodium, Total Bilirubin, Total protein, Urea/ Blood urea nitrogen (BUN) were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.|Up to Day 59|Safety Population. Only those par. available at the indicated time point were analyzed.|||Participants|||Count of Participants
2731376|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4|Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
2739114|NCT00957359|Primary|HADS Depression|Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)|6 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2731303|NCT01009086|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.|||Score on a scale||Standard Deviation|Mean
2731304|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
2731305|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
2731306|NCT01009086|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.|||Percentage of participants|||Number
2731307|NCT01009086|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Score on a scale||Standard Deviation|Mean
2731308|NCT01009086|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
2731309|NCT01009060|Secondary|Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment|One Pharmacokinetic (PK) sample was collected within 15 minutes prior to the start of the CSSB and one PK sample was collected within 15 minutes after completion of the CSSB. 'n' was the number of samples available for analysis.|15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7|PK-concentration population included all par. for whom a PK sample was obtained and analyzed. Number of units analyzed are number of samples available for analysis.|||nanograms per milliliter (ng/mL)|Plasma sample|Geometric Coefficient of Variation|Geometric Mean
2731406|NCT01008462|Primary|Event-Free Survival (EFS)|Number of patients surviving without relapsed/progressive disease|1 Year post-autograft||||Participants|||Count of Participants
2743457|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms.||2 years||||percentage of participants|||Number
2731312|NCT01009060|Secondary|Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment|Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Hemoglobin concentration (MCHC), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red blood cell count (RBC), Reticulocytes, Neutrophils count and White blood cell (WBC) count were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.|Up to Day 59|Safety Population. Only those par. available at the indicated time point were analyzed.|||Participants|||Count of Participants
2731313|NCT01009060|Secondary|Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range|Heart rate readings were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the participant got discharged. It was measured in both supine and standing position. For both Std and Sup positions, heart rate data of concern was <50 or >100 and IFB >=30; <50 or >100 and DFB >=30. Data with only abnormal values were presented.|Up to Day 59|Safety Population. Only those par. available at the specified time points were analyzed.|||Participants|||Count of Participants
2731314|NCT01009060|Secondary|Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range|Blood pressure readings both systolic and diastolic were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the par. got discharged. Blood pressure was measured in both standing (Std) and supine (Sup) position. Data with only abnormal values were presented. For SBP the data of concern was <90 or >140 and increase from Baseline (IFB) >=40; <90 or >140 and decrease from Baseline (DFB) >=30. For DBP the data of concern was <50 or >90 and IFB >=30; <50 or >90 and DFB >=20.|Up to Day 59|Safety Population. Only those par. available at the specified time points were analyzed.|||Participants|||Count of Participants
2731315|NCT01009060|Secondary|Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings|Triplicate 12-lead ECGs were obtained at Baseline (screening visit). Single 12-lead ECGs were obtained at each subsequent time point during the study. Abnormal ECG findings were presented for the most severe on-treatment result.|Up to Day 59|Safety Population. Only those participants who showed most severe on-treatment abnormal ECG findings are presented.|||Participants|||Count of Participants
2731316|NCT01009060|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Day 59|Safety Population consisted of all randomized par. who took at least one dose of investigational product.|||Participants|||Count of Participants
2731317|NCT01009060|Secondary|Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7|The UPSA is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains- comprehension and planning, finance, communication, mobility and house management. When combined, measures functional capacity. The comprehension and planning ranges from 0 to 14, the finance ranges from 0 to 11, the communication ranges from 0 to 12, the mobility ranges from 0 to 9, and the house management ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was score at a given time post Baseline minus Baseline score|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2731318|NCT01009060|Secondary|Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7|The SANS was a tool used to assess five symptom complexes to obtain clinical ratings of negative symptoms in par. with schizophrenia. Complexes include: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessment was conducted on six-point scale (0=not at all to 5=severe) for a total scoring range of 0-120. Lower scores represent better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2731319|NCT01009060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; lower score is 18 and highest score is 126. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2731326|NCT01009047|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182|"The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Full Range|Median
2734084|NCT00990938|Primary|At Least 1 TEAE|The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category.|From first dose of study treatment to day 59 (end of study)|Safety population|||Participants|||Count of Participants
2731320|NCT01009060|Secondary|Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7|MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants at indicated time point were analyzed.|||T-scores||Standard Error|Least Squares Mean
2731321|NCT01009060|Secondary|Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7|The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.|Baseline and Week 7|ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.|||Scores on a scale||Standard Error|Least Squares Mean
2731322|NCT01009060|Secondary|Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7|MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2731323|NCT01009060|Primary|Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512|The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.|Baseline and up to Week 7|ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.|||Scores on a scale||Standard Error|Least Squares Mean
2731324|NCT01009047|Secondary|Number of Participants With PANSS Response|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Participants|||Number
2731325|NCT01009047|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182|The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a Scale||Standard Deviation|Mean
2731338|NCT01008995|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.|Scores could range from 0 (mild) to 72 (severe).|Baseline (Week 0) to Week 12|All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.|||Participants|||Number
2731327|NCT01009047|Secondary|Number of Participants With Clinical Stability|Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Participants|||Number
2731328|NCT01009047|Secondary|Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
2731329|NCT01009047|Secondary|Change From Baseline in Other Marder Factors Scores at Day 56 and 182|The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
2731330|NCT01009047|Secondary|Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182|The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
2731331|NCT01009047|Secondary|Change From Baseline in PANSS Total Score at Day 182|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
2731332|NCT01009047|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 56|The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
2731333|NCT01009034|Secondary|Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.||6 months||||h*mg/L||Inter-Quartile Range|Median
2731334|NCT01009034|Secondary|Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval|For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample||||ratio||Inter-Quartile Range|Mean
2731335|NCT01009034|Primary|Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals.|||Inhibitory concentration ratio||Inter-Quartile Range|Median
2731336|NCT01008995|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline (Week 0) to Week 12|Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.|||Score||Standard Deviation|Mean
2731337|NCT01008995|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|All participants were included and analyzed according to their randomized treatment group.|||Participants|||Number
2731357|NCT01008722|Primary|Survival Free of Atrial Fibrillation|Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds.|6 -12 months||||participants|||Number
2731339|NCT01008969|Secondary|Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. We calculated the percentage of images with detectable lymph nodes from SPECT/CT images in these participants.|||percentage of images identifying LNs|||Number
2731340|NCT01008969|Primary|Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection|Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. Percentage of participants who received SPECT/CT scans of 99mTc-sulfur nanocolloid was analyzed.|||Percentage of Participants|||Number
2731341|NCT01008943|Primary|Number of Participants That Experienced AMDC Product-related Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.~No adverse events reported during the study were adjudicated as AMDC product-related."|12 months||||participants|||Number
2731342|NCT01008943|Primary|Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days||||events|||Number
2731343|NCT01008943|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days||||participants|||Number
2731344|NCT01008943|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.|at biopsy or between biopsy and treatment, approximately 6 weeks|One patient experienced procedural dizziness.|||participants|Participants||Number
2731345|NCT01008904|Secondary|Difference in Quality of Life|Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.|from baseline to week 5|Participants who completed treatment|||units on a scale||Standard Error|Mean
2731346|NCT01008904|Primary|Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)|Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.|from baseline to week 5|25 patients completed the complete study and were analyzed|||percentage of difference||Standard Error|Mean
2731347|NCT01008748|Primary|7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence|Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach|Week 26 post quit day|Continuous Abstinence Completers-only|||Participants|||Count of Participants
2731348|NCT01008748|Primary|7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence|Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach|Week 3 post quit day|Continuous Abstinence Completers-only|||Participants|||Count of Participants
2731349|NCT01008748|Primary|7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat|Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach|Week 26 post quit day|Continuous Abstinence Intent-to-treat|||Participants|||Count of Participants
2731350|NCT01008748|Primary|7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat|Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach|Week 3 post quit day|Continuous Abstinence Intent-to-treat|||Participants|||Count of Participants
2731351|NCT01008748|Primary|30-Day Smoking Abstinence (Week 26 Post Quit Day)|Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.|Week 26 post quit day|Completers only|||Participants|||Count of Participants
2731352|NCT01008748|Primary|7-Day Smoking Abstinence (Week 26 Post Quit Day)|Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.|Week 26 post quit day|Completers only|||Participants|||Count of Participants
2731353|NCT01008748|Primary|7-Day Smoking Abstinence (Week 3 Post Quit Day)|Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.|Week 3 post quit day|Completers-only|||Participants|||Count of Participants
2731354|NCT01008748|Primary|24-Hour Smoking Abstinence (Week 26 Post Quit Day)|Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.|Week 26 post quit day|Completers -only|||Participants|||Count of Participants
2731355|NCT01008748|Primary|Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)|Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.|Week 3 post quit day|Completers-Only|||Participants|||Count of Participants
2731356|NCT01008722|Secondary|Termination or Slowing of Atrial Fibrillation During Ablation|Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus.|acute||||Participants|||Count of Participants
2731359|NCT01008696|Secondary|Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire|Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping.|Baseline and Day 57|The FAS included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure|||Units on a scale||Standard Deviation|Mean
2731360|NCT01008696|Primary|Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19|Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers.|Day 57|The Full analysis set (FAS) included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure.|||Percentage of participants|||Number
2731361|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
2731362|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Participants|||Number
2731363|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731364|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731365|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731366|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731367|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
2731368|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
2731369|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied."|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
2731370|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied."|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
2731371|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported."|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2731372|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported."|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2731373|NCT01008618|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Days||95% Confidence Interval|Median
2731374|NCT01008605|Secondary|Number of Participants Providing Comments to Any Question on the Participant Assessment Tool|Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
2731375|NCT01008605|Secondary|Time Required to Perform Each Step While Using the Caverject Impulse Delivery System|Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.|Day 1|FAS. Each participant tested one device/dose combination. n = number of participants with available data.|||seconds||Standard Deviation|Mean
2731377|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3|Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
2731378|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2|Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
2731379|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1|Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
2731380|NCT01008605|Primary|Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System|Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (>) 80% overall.|Day 1|Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.|||percentage of participants|||Number
2731381|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
2731382|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Participants|||Number
2731383|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731384|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731385|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731386|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2731459|NCT01007838|Primary|Muscle Cross Sectional Area|Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.|Change from baseline in cross sectional area at 12 weeks|Per protocol. All participants completing the study were analyzed.|||cm2||Standard Deviation|Mean
2731387|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
2731388|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
2731389|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied."|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
2731390|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied."|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
2731391|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported."|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2731392|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported."|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2731393|NCT01008553|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Days||95% Confidence Interval|Median
2731394|NCT01008475|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.|Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||months||95% Confidence Interval|Median
2731407|NCT01008449|Secondary|Subject Satisfaction With Location of Scar|Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar|at end of follow-up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
2731395|NCT01008475|Secondary|Number of Subjects With Tumor Response|Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.|Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||Subjects|||Number
2731396|NCT01008475|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.|Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||months||95% Confidence Interval|Median
2731397|NCT01008475|Secondary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.|Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||months||95% Confidence Interval|Median
2731398|NCT01008475|Primary|Randomized Part: Progression Free Survival (PFS)|PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.|Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups.|||months||95% Confidence Interval|Median
2731399|NCT01008475|Primary|Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)|DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.|Time from the first dose of study drug up to 2 weeks|Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation.|||subjects|||Number
2731400|NCT01008462|Secondary|Number of Patients Who Had Infections|Number of patients who had infections.|1 Year post-autograft||||Participants|||Count of Participants
2731401|NCT01008462|Secondary|Number of Patients Who Engrafted|Number of patients with donor engraftment.|Day 84 post-allograft|Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.|||Participants|||Count of Participants
2731402|NCT01008462|Secondary|Non-relapse Mortality (NRM)|Number of patients with non-relapse mortalities.|200 days and 1 Year post-allograft|Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.|||Participants|||Count of Participants
2731403|NCT01008462|Secondary|Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease|"aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).~GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death~CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD."|1 year post-allograft,|Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.|||Participants|||Count of Participants
2731404|NCT01008462|Secondary|Overall Survival|Number of patients surviving one year post-autograft|1 year post-autograft||||Participants|||Count of Participants
2731405|NCT01008462|Secondary|Number of Patients With Relapsed/Progressive Disease|"Relapse/Progression defined as:~Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies.~Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy ."|1 year post-autograft||||Participants|||Count of Participants
2731413|NCT01008449|Secondary|Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))|The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).|at the end of follow up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
2731414|NCT01008449|Primary|Percent of Subjects With Composite Wound Morbidity.|this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed|4-6 weeks post partum||||percentage of subjects|||Number
2731415|NCT01008423|Secondary|Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.|Baseline, Week 6|ITT population included all randomized participants. Here, ‘Number analyzed’ signifies number of participants evaluable for specified categories.|||unit on a scale||Standard Deviation|Mean
2731416|NCT01008423|Secondary|Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731417|NCT01008423|Secondary|Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731418|NCT01008423|Secondary|Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731419|NCT01008423|Secondary|Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731420|NCT01008423|Secondary|Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency (BF) and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731421|NCT01008423|Secondary|Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731521|NCT01007253|Secondary|Total Number of Sneezes||50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||sneezes||Full Range|Median
2731422|NCT01008423|Secondary|Number of Scheduled Assessments With Rectal Bleeding Responder Classification|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method.|Weeks 1, 2, 4, and 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731423|NCT01008423|Secondary|Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731424|NCT01008423|Primary|Percentage of Participants Who Achieved Remission|Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).|Week 6|ITT population included all randomized participants. Missing data was imputed using last observation carried forward (LOCF) method.|||percentage of participants|||Number
2731425|NCT01008410|Secondary|Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.|Baseline, Week 6|ITT population included all randomized participants.|||unit on a scale||Standard Deviation|Mean
2731426|NCT01008410|Secondary|Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731427|NCT01008410|Secondary|Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731428|NCT01008410|Secondary|Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731429|NCT01008410|Secondary|Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Physician global assessment (PGA) subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2734104|NCT00990652|Other Pre-specified|Pharmacokinetics of Bortezomib in Tumor Tissue Taken at the Time of Surgery.||Tissue sample taken at the time of surgery for all patients.|||||||
2731430|NCT01008410|Secondary|Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Bowel frequency (BF) subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731431|NCT01008410|Secondary|Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731432|NCT01008410|Secondary|Number of Scheduled Assessments With Rectal Bleeding Responder Classification|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method.|Weeks 1, 2, 4, and 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731433|NCT01008410|Secondary|Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6|The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method.|Week 6|ITT population included all randomized participants.|||percentage of participants|||Number
2731434|NCT01008410|Primary|Percentage of Participants Who Achieved Remission|Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).|Week 6|ITT population included all randomized participants. Missing data was imputed using last observation carried forward (LOCF) method.|||percentage of participants|||Number
2731435|NCT01008319|Secondary|Delivery Outcomes|Proportion of participants that delivered a baby based on which protocol they were randomized to.|5 years|Number of participants randomized to each arm.|||Participants|||Count of Participants
2731436|NCT01008319|Secondary|Rate of Ovulation|Rate of ovulation with each dose of clomid within each protocol|5 years|Proportion of subjects that ovulated at each dose of Clomid based on which protocol they were randomized to.|||Participants|||Count of Participants
2731437|NCT01008319|Primary|Time to Ovulation With Each Protocol|We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.|5 years||||days||Standard Error|Mean
2731438|NCT01008280|Primary|Number of Heavy Drinking Days Per Two Week Segment|A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male|12 weeks||||Number of heavy drinking days/2 weeks||Standard Error|Mean
2731439|NCT01008280|Primary|Number of Drinks Consumed Per Two Week Segments||12 weeks||||Number of Drinks/2 Weeks||Standard Error|Mean
2731440|NCT01008280|Primary|Number of Drinking Days in the Past Two Weeks||12 Weeks||||Number of Drinking Days/2 weeks||Standard Error|Mean
2731441|NCT01008150|Secondary|Adverse Events Experienced by Participants as a Measure of Toxicity|Number of patients with at least one adverse event.|Assessed through 2 years from randomization|Refer to Adverse Events section for more details.|||Participants|||Count of Participants
2731442|NCT01008150|Secondary|Overall Survival|Number of participants alive at 24 months.|24 months||||Participants|||Count of Participants
2731443|NCT01008150|Secondary|Recurrence-free Interval (RFI)|Number of participants with no events of inoperable progressive disease and local, regional and distant recurrence.|2 years||||Participants|||Count of Participants
2731444|NCT01008150|Secondary|Clinical Complete Response, as Measured by Physical Exam|Upon physical exam the number of participants with resolution of all target and non-target lesions identified at baseline and no new lesions or other signs of disease progression.|At the completion of AC prior to surgery, approximately 7 months|Only patients with palpable disease at baseline are included in this outcome. Arm1-38 patients at baseline, 2 patients missing data. Arm 2-35 patients at baseline, 4 patients missing data. Arm 3-38 patients at baseline, 4 patients missing data. Arm 3 NR-10 patients at baseline, 1 patient missing data.|||Participants|||Count of Participants
2731445|NCT01008150|Secondary|Pathologic Complete Response in Breast.|Number of participants with by no histologic evidence of invasive tumor cells in the surgical breast specimen.|At time of surgery, approximately 7 months||||Participants|||Count of Participants
2769191|NCT00744380|Secondary|Cumulative Doses of Conventional Sedatives and Analgesics||Duration of ICU stay, for up to 24 weeks||||mg||Inter-Quartile Range|Median
2731448|NCT01007916|Primary|Comfort Upon Insertion|Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.|||Units on a Scale||Standard Deviation|Mean
2731449|NCT01007942|Secondary|Trastuzumab Blood Concentrations by Leading Dose and Time Point|Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.|Cycle 3, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.|||ng/ml||Standard Deviation|Mean
2731450|NCT01007942|Secondary|Vinorelbine Blood Concentrations by Leading Dose and Time Point|Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.|Cycle 2, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.|||ng/ml||Standard Deviation|Mean
2731451|NCT01007942|Secondary|Everolimus Blood Concentrations by Leading Dose and Time Point|Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.|Cycle 2, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.|||ng/ml||Standard Deviation|Mean
2731452|NCT01007942|Secondary|PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)|PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, & social functioning [EF, PF, & SF]). It contains 30 items & is composed of multi-item scales & single-item measures. These include 5 functional scales (physical, role, emotional, social & cognitive functioning), 3 symptom scales (fatigue, pain, nausea, & vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia & financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest & disclosed here.|Baseline, until disease progression or death up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
2731453|NCT01007942|Secondary|Median Time to Deterioration of the ECOG Performance Status Score|Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, & physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead|baseline, until disease progression or death up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
2731454|NCT01007942|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2731455|NCT01007942|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2731456|NCT01007942|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.|Every 3 months until death up to 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
2731457|NCT01007942|Primary|Progressive-free Survival (PFS) Per Investigator Assessment|PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
2731460|NCT01007812|Primary|Overall Vision|Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per Protocol|||Units on a Scale||Standard Deviation|Mean
2731461|NCT01007656|Primary|R-glutamyl Transpeptidase (r-GT)||90 days||||U/L||Standard Deviation|Mean
2731462|NCT01007656|Primary|Glucose||90 days||||mg/dL||Standard Deviation|Mean
2731463|NCT01007656|Primary|Globulin||90 days||||g/dL||Standard Deviation|Mean
2731464|NCT01007656|Primary|Creatinine||90 days||||mg/dL||Standard Deviation|Mean
2731465|NCT01007656|Primary|Cholesterol||90 days||||mg/dL||Standard Deviation|Mean
2731466|NCT01007656|Primary|BUN||90 days||||mg/dL||Standard Deviation|Mean
2731467|NCT01007656|Primary|Total Bilirubin|Bilirubin is released into the blood when red blood cells break down. The liver uses bilirubin to make bile. Normally there is only a small amount of bilirubin in the blood. High levels may be caused by liver or blood problems.|90 days||||mg/dL||Standard Deviation|Mean
2731468|NCT01007656|Primary|Direct Bilirubin|Direct bilirubin is referred to as conjugated bilirubin, which is water-soluble. It's taken up by the liver cells and conjugated to form the water-soluble bilirubin diglucuronide. It's used to diagnose and/or monitor liver diseases, such as cirrhosis, hepatitis or gallstones. If direct bilirubin is elevated more than unconjugated bilirubin, there's typically a problem associated with decreased elimination of bilirubin by the liver cells.|90 days||||mg/dL||Standard Deviation|Mean
2731469|NCT01007656|Primary|Alkaline Phosphatase||90 days||||U/L||Standard Deviation|Mean
2731470|NCT01007656|Primary|Albumin||90 days||||g/dL||Standard Deviation|Mean
2731471|NCT01007656|Primary|Uric Acid||90 days||||mg/dL||Standard Deviation|Mean
2731472|NCT01007656|Primary|Total Protein|The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.|90 days||||g/dL||Standard Deviation|Mean
2731473|NCT01007656|Primary|Triglycerides (TG)||90 days||||mg/dL||Standard Deviation|Mean
2731474|NCT01007656|Primary|Serum Glutamic Pyruvate Transaminase (ALT/SGPT)||90 days||||U/L||Standard Deviation|Mean
2731475|NCT01007656|Primary|Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)||90 days||||U/L||Standard Deviation|Mean
2731476|NCT01007643|Secondary|Change in Vastus Medialis Oblique Muscle Strength||3 months|||||||
2731477|NCT01007643|Secondary|Change in Quadriceps Flexibility||3 months|||||||
2731478|NCT01007643|Secondary|Change in Hamstring Flexibility||3 months|||||||
2731479|NCT01007643|Secondary|Changes in Patellofemoral Symptoms||3 months|||||||
2731480|NCT01007643|Primary|Percentage of Exercise Days Completed.|Calculated for the 12 week period as daily exercise completion rate as percentage|3 months|Per Protocol|||percentage of days completed||Full Range|Mean
2731481|NCT01007591|Secondary|The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF|"For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below:~Redness 0.none~mild~moderate~severe~very severe~Thickness~0.none~mild~moderate~severe~very severe~Scaliness~0.none~mild~moderate~severe~very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12."|From baseline (Day 0) to end of treatment (Week 8)|The intertriginous analysis set consisted of all participants having 'Mild' or worse according to IGA of the intertriginous areas at baseline. The intertriginous analysis set therefore consisted of 11 participants.|||percentage in TSS||Standard Deviation|Mean
2731482|NCT01007591|Secondary|"Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF"|"At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale.~Clear, almost clear, mild, moderate, severe and very severe.~For subjects with a baseline (Day 0) severity of moderate or worse - controlled disease of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas.~For subjects with a baseline (Day 0) severity of mild - controlled disease of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas."|At end of treatment (Week 8)|The intertriginous analysis set consisted of all participants having ‘Mild’ or worse according to IGA of the intertriginous areas at baseline. The intertriginous analysis set therefore consisted of 11 participants.|||Participants|||Count of Participants
2731483|NCT01007591|Secondary|The Percentage Change in PASI of the Face LOCF at Week 4|"PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:~0.05 (R+T+S) E It ranged from 0 to 3.6."|From baseline (Day 0) to Week 4 (Day 28)||||percentage of change in PASI||Standard Deviation|Mean
2731484|NCT01007591|Secondary|"Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF"|"For subjects with a baseline (Day 0) severity of moderate or worse - controlled disease of the face was defined as clear or almost clear according to the IGA of the face.~For subjects with a baseline (Day 0) severity of mild - controlled disease of the face was defined as clear according to the IGA of the face.~At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.~Clear, almost clear, mild, moderate, severe and very severe."|At end of treatment (Week 8)||||Participants|||Count of Participants
2731485|NCT01007591|Primary|The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment|"PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:~0.05 (R+T+S) E~It ranged from 0 to 3.6."|From baseline (Day 0) to end of treatment (Week 8)||||percentage of change in PASI||Standard Deviation|Mean
2731535|NCT01007123|Secondary|Stool Consistency Change From Baseline|Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.|Baseline, weekly and up to 8 weeks|ITT population|||units on a scale (1-7)||Standard Deviation|Least Squares Mean
2731486|NCT01007552|Secondary|Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional)|This was a tissue banking end point of sample collection for future studies. No analysis was completed.|Baseline, day 8 and day 43|No patients were analyzed and no data were collected for this Outcome Measure. This was an optional aim and the research team decided to opted out of analyzing.||||||
2731487|NCT01007552|Secondary|Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43|Mean number of CTCs in 7.5 ml of whole blood|baseline, day 22 and day 43|All treated and eligible patients|||cells||Standard Deviation|Mean
2731488|NCT01007552|Secondary|Assess Overall Survival (OS)||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Mean
2731489|NCT01007552|Secondary|Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.|"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life.~For a Detailed description see:~Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239.~No subscales were analyzed.~."|Baseline, Day 22 and Day 43|All treated and eligible patients. Some measures were not complete for leading to missing values.|||units on a scale||Standard Deviation|Mean
2731490|NCT01007552|Secondary|Assess the Toxicity of the Regimen.|Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail.|up to 5 years|All treated and eligible patients|||participants|||Number
2731491|NCT01007552|Secondary|Estimate the Proportion of Patients With Clinical Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2731492|NCT01007552|Primary|The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.|"Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term evaluable in reference to measurability will not be used because it does not provide additional meaning or accuracy."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2731493|NCT01007526|Secondary|Overall Response Rate, Survival, Toxicity||Up to 5 years after the completion of treatment|||||||
2731494|NCT01007526|Primary|Compete Response Rate|Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease|Within 3 weeks after the completion fo treatment||||participants|||Number
2731495|NCT01007448|Secondary|Time to Tumor Progression as Determined by Percent BSA Involvement|Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. PD=an increase from Baseline in percent BSA of at least 25%.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with progression.|||days||Standard Deviation|Mean
2731496|NCT01007448|Secondary|Time to Tumor Progression as Determined by PGA of Clinical Condition|Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. PD=PGA grade of 6 (worse disease [≥25%] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with progression.|||days||Standard Deviation|Mean
2731497|NCT01007448|Secondary|Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity|Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Criteria for PD requires at least 1 component of the following: CA ratio=≥1.25, ≥25% increase in number/aggregate area of abnormal lymph nodes/tumors, or no new abnormal lymph nodes in documented area of absence of disease.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with evaluable PD data for CA of index lesion disease severity.|||days||Standard Deviation|Mean
2731536|NCT01007123|Secondary|Time to First Bowel Movement||First week|ITT population|||hours||95% Confidence Interval|Median
2731537|NCT01007123|Secondary|Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)|"A CSBM responder is defined as per FDA draft guidance for IBS-C:~An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment"|Baseline, weekly and up to 8 weeks|ITT population|||participants|||Number
2731498|NCT01007448|Secondary|Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement|Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement.|||days||Standard Deviation|Mean
2731499|NCT01007448|Secondary|Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition|Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline).|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition.|||days||Standard Deviation|Mean
2731500|NCT01007448|Secondary|Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity|Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of CTCL histologic signs); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease).|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity.|||days||Standard Deviation|Mean
2731501|NCT01007448|Secondary|Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement|Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement.|||days||Standard Deviation|Mean
2731502|NCT01007448|Secondary|Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition|Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline).|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition.|||days||Standard Deviation|Mean
2731503|NCT01007448|Secondary|Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity|Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, absence of CTCL histologic signs); CCR (CA ratio=0; no clinically abnormal lymph nodes); PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, no new abnormal lymph nodes in documented area of absence of disease).|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity.|||days||Standard Deviation|Mean
2731504|NCT01007448|Primary|Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement|To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. SD=none of the response classifications (that is, CR, CCR, PR, or PD) accurately describe the disease status. PD=an increase from Baseline in percent BSA of at least 25%.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population).|||Participants|||Count of Participants
2731505|NCT01007448|Primary|Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition|The PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). Stable Disease (SD)=PGA grade of 4 (slight improvement [<25%-<50%] of disease since Baseline) or 5 (no change in disease [+/-<25% change since Baseline]). Progressive Disease (PD)=PGA grade of 6 (worse disease [≥25%] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant.|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population).|||Participants|||Count of Participants
2731506|NCT01007448|Primary|Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity|Index lesion symptoms/grade include: erythema=0 (no evidence)-8 (very severe); scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence of change)-8 (very severe change); area of involvement=0 (0 centimeters [cm]^2)-18 (>300 cm^2). CA generated by sum of grades of signs/symptoms for each index lesion. Index lesion CA grade at baseline was divided into CA grade at each subsequent study visit to determine participant's response to treatment. Ratio of CA <1.0=improvement in disease; ratio >1.0=worsening of disease. Tumor response as determined by CA=percentage of participants achieving CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of histologic signs of CTCL); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease).|Baseline up to Week 24|Participants who received at least 1 dose of study drug (Full Analysis Population).|||Participants|||Count of Participants
2731507|NCT01007435|Secondary|Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52|The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
2731508|NCT01007435|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52|The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
2731509|NCT01007435|Secondary|Percentage of Participants With a Major Clinical Response at Week 52|A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
2731510|NCT01007435|Secondary|Change From Baseline in Sharp Joint Space Narrowing Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
2731511|NCT01007435|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
2731512|NCT01007435|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
2731522|NCT01007253|Secondary|Total Nasal Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one nostril and was asked to rate nasal symptoms (congestion, rhinorrhea, and itchy nose/throat) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of nasal symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other nostril. The outcome is the total number of score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (congestion, rhinorrhea, and itchy nose/throat), and nostrils (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||units on a scale||Full Range|Median
2731513|NCT01007435|Secondary|Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52|"Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing."|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
2731514|NCT01007435|Secondary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52||Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
2731515|NCT01007435|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24|A participant has a DAS28 remission response if their DAS28 < 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Week 24|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
2731516|NCT01007396|Secondary|Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)|"The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation~Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution.~The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml."|3 months after LTBI treatment|Thirteen participants agreed to undergo treatment for latent tuberculosis infection and completed 3 months therapy.|||Percentage of participants|||Number
2731517|NCT01007396|Primary|Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea|The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).|QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.|Of the 322 healthcare workers (HCWs), 275 (85%) underwent repeat QuantiFERON-TB Gold In-Tube test (QFT-IT test) after 1 year of employment; the 47 participants who had resigned were excluded. Two participants with indeterminate results on the baseline QFT-IT test were excluded from the analysis.|||number of new cases per 1000 person/year|||Number
2731518|NCT01007253|Secondary|Total Number of Eosinophils|The percentage of eosinophils among white blood cells was determined under light microscopy at 1000x magnification, and the total number of eosinophils in each lavage was then calculated. The specimens that had no eosinophils identified on differential counting despite adequate cells on the smear were assigned a number that corresponded to the lowest number of eosinophils on a slide where the number could be counted. That number was 33 total eosinophils.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||eosinophils||Full Range|Median
2731519|NCT01007253|Secondary|Change in Tryptase Level (Across Nasal Challenges)|"Tryptase is an enzyme that is released, along with histamine and other chemicals, from mast cells when they are activated, often as part of an allergic immune response. Tryptase in nasal lavages was measured using the ImmunoCap tryptase assay, by Phadia (Uppsala, Sweden). The limit of detection of the assay is 1.0 ng/mL, and levels below this value were arbitrarily assigned a value of 0.5 ng/mL.~For each patient, tryptase levels recorded after the diluent challenge were subtracted from tryptase levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in tryptase level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||ng/mL||Full Range|Median
2731520|NCT01007253|Secondary|Change in Histamine Level (Across Nasal Challenges)|"Histamines are simple chemical substances produced by immune system cells when reacting to an antigen in response to foreign invaders like germs and bacteria.~Histamine in nasal lavages was measured using a histamine enzyme immunoassay kit market by SPI-BIo, Bertin Pharma (Montigny le Bretonneux, France). The limit of detection of the assay is 0.4 nM, and levels below the detection limit were arbitrarily assigned a value of 0.2 nM. Samples that yielded values above the upper detection limit of the assay were diluted and reassayed.~For each patient, histamine levels recorded after the diluent challenge were subtracted from histamine levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in histamine level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||nM||Full Range|Median
2731523|NCT01007253|Primary|Total Eye Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||units on a scale||Full Range|Median
2731524|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI|||Percent change in MFI||Standard Deviation|Mean
2731525|NCT01007149|Secondary|Number of Patients With at Least One Asthma-related Event Over 16 Weeks|Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Participants|||Number
2731526|NCT01007149|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks|Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Liters||Standard Deviation|Mean
2731527|NCT01007149|Secondary|Physician and Patient Global Evaluation of Treatment Effectiveness|The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Participants|||Number
2731528|NCT01007149|Secondary|Change From Baseline in Nasal Symptom Global Score and Individual Components|Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Score units||Standard Deviation|Mean
2731529|NCT01007149|Secondary|Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)|The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Score units||Standard Deviation|Mean
2731530|NCT01007149|Secondary|Change From Baseline in Induced Sputum Eosinophil Count|The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.|Baseline and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Only patients with measurements at both baseline and week 16 were included in this analysis.|||Percentage of total nonsquamous cells||Standard Deviation|Mean
2731531|NCT01007149|Secondary|Change in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.|Baseline and 4, 8, 12 and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. During different time points, participants with observations at that time point were included in the analysis.|||parts per billion (ppb)||Standard Deviation|Mean
2731532|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI|||Percent change in MFI||Standard Deviation|Mean
2731533|NCT01007123|Secondary|Straining Change From Baseline|Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.|Baseline and during 8 weeks of treatment|ITT population|||units on a scale (1-5)||Standard Error|Least Squares Mean
2731541|NCT01007110|Secondary|Maternal Red Blood Cell (RBC) Phospholipids at Delivery|Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).|Time of delivery, 36 weeks to term||||weight percent Total Fatty Acids||Inter-Quartile Range|Median
2731542|NCT01007110|Secondary|Neonatal Behavioral Assessment Scale (NBAS) Scores|"The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.~For behavioral items a higher score corresponds to more desirable outcomes:~Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.~Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 - 63.~Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.~Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.~Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.~Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.~Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite."|within 2 weeks of delivery||||units on a scale||Standard Deviation|Mean
2731543|NCT01007110|Primary|Heart Rate|Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.|24, 32 and 36 weeks gestational age|"Placebo: 19 subjects @ 24 wks GA, 25 subjects @ 32 wks GA, 24 subjects @ 36 wks GA~DHA: 21 subjects @ 24 wks GA, 23 subjects @ 32 wks GA, 22 subjects @ 36 wks GA"|||Beats per minute||Standard Deviation|Mean
2731544|NCT01007071|Secondary|Neuropsychological Testing of Executive Function|Executive function was assessed in part B of the 2-part Trail Making Test. In Part A, 25 circles are distributed over a sheet of paper, numbered 1 - 25, and the patient draws lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient is instructed to connect the circles as quickly as possible. The amount of time the patient takes to connect the circles is recorded as their score. If patients make an error, they are corrected then continue from the last correct circle. The number of seconds for completion of part B is reported, therefore higher scores reveal greater impairment.|16 weeks||||seconds||Standard Deviation|Mean
2731545|NCT01007071|Primary|BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI|Functional MRI scans were to be performed at baseline and at 16 weeks. Changes in functional connectivity before and after 16 weeks of treatment were analyzed. The analysis involved approximately 40,000 paired sample t-tests. The dependent variable here for each subject is the correlation between the BOLD timeseries in the seed region (posterior cingulate cortex) and the BOLD timeseries in a given, standard space, brain voxel. This paired-sample t-test is run, separately, for every voxel in the brain. The pre-specified Outcome Measure intended to report the number of voxels that showed significant changes with active treatment. A preliminary analysis was conducted using a paired-sample t-test at each of the 40,000+ voxels, however, none of the voxels reached the level of significance. Since no significant voxels were detected, subsequent planned analyses were not performed, and summary level data cannot be reported for this Outcome Measure.|Baseline and 16 weeks|Preliminary analysis did not work as intended and subsequent data were not collected from any participants (please see the detailed explanation in the Measure Description).||||||
2731546|NCT01007032|Primary|Drug Clearance (CL)||Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 hours) Following End of Infusion|All participants who received at least 1 dose of study drug and had evaluable PK data for CL estimation (First Dose and Fourth doses for Cohorts 1 and 2 and First Dose and Third doses for Cohorts 3 and 4.)|||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2731547|NCT01007032|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions.|From the First Dose up to 32 Months|All participants who received 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2731548|NCT01007032|Primary|Half-life (t1/2)||Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 hours) Following End of Infusion|All participants who received at least 1 dose of study drug and had evaluable PK data for t1/2 estimation (First Dose and Fourth doses for Cohorts 1 and 2 and First Dose and Third doses for Cohorts 3 and 4.)|||day||Full Range|Geometric Mean
2731549|NCT01007032|Primary|PK: Area Under Concentration Versus Time Curve During One Dosing Interval (AUCtau)||Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 Hours Following End of Infusion|All participants who received 1 dose of study drug and had evaluable PK data for (AUCtau). Fourth doses for Cohorts 1 and 2. No participant was evaluable in Cohorts 3 and 4.|||(μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2731550|NCT01007032|Secondary|Number of Participants With Serum Anti-Cixutumumab Antibody Assessment Immunogenicity|No participants were analyzed for the development of circulating positive anti-cixutumumab antibodies due to no assay available.|6 months|No participants were analyzed due to no assay available.||||||
2731551|NCT01007032|Primary|PK: Area Under the Curve From Zero to Infinity AUC(0-∞)||Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 Hours Following End of Infusion|All participants who received at least 1 dose of study drug and had evaluable PK data for AUC(0-∞). First Dose for Cohorts 1, 2, 3, and 4.|||micrograms•hour/milliliter (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2743921|NCT00925054|Secondary|Number of Participants With Positive PEG IgM Antibody|Antibody positivity over time|Baseline, Week 16|safety population|||Participants|||Count of Participants
2731552|NCT01007032|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax)||Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 Hours Following End of Infusion|All participants who received at least 1 dose of study drug and had evaluable PK data for Cmax (First Dose and Fourth doses for Cohorts 1 and 2 and First and Third doses for Cohorts 3 and 4.)|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2731553|NCT01007032|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|DLTs were defined as any cixutumumab-related Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) Grade 3 or 4 adverse events (reported in the subsequent Primary Outcome Measure).|First Dose Up to 6 Weeks|All participants who completed the first cycle of 6 weeks or discontinued due to Dose Limiting Toxicities (DLTs).|||participants|||Number
2731554|NCT01007032|Primary|Summary Listing of Percentage of Participants Reporting Treatment-Emergent Adverse Events|A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Up To 63 Months|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2731555|NCT01006980|Secondary|Pre and Post-dose Plasma Vemurafenib Concentration by Study Day|The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.|Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).|"The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. n indicates the number of participants with available PK data at each time point."|||μg/mL||Standard Deviation|Mean
2731556|NCT01006980|Secondary|Number of Participants With Adverse Events (AEs)|The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.|From randomization (initiated January 2010) until December 30, 2010.|The safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received.|||participants|||Number
2731557|NCT01006980|Secondary|Time to Treatment Failure|Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.|approximately 3 years|||||||
2731558|NCT01006980|Secondary|Time to Confirmed Response|Time to response was defined as the time from randomization to confirmed response (complete response or partial response).|From randomization (initiated January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.|||months||Full Range|Median
2731559|NCT01006980|Secondary|Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.|From randomization (initiated in January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.|||months||95% Confidence Interval|Median
2731560|NCT01006980|Secondary|Participants With a Best Overall Response (BOR) of Complete Response or Partial Response|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.|From randomization (initiated January 2010) until December 30, 2010|The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.|||participants|||Number
2731561|NCT01006980|Primary|Progression-free Survival|A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).|From randomization (initiated January 2010) to December 30 2010.|The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan.|||participants|||Number
2731562|NCT01006980|Primary|Overall Survival|An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.|From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).|The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.|||participants|||Number
2731753|NCT01005719|Secondary|Median 24-hr Intragastric pH on Day 7|The median intragastric pH values were recorded over a 24-hr period.|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||pH||Full Range|Median
2731563|NCT01006967|Secondary|Change in Activities-specific Balance Confidence From Baseline|The Activity-specific Balance Confidence scale (ABC) is a patient self-report measure tthat measures the subject's self-assessed confidence in being able to perform 16 specific activities without losing their balance or becoming unsteady. For each task (i.e. walking around the house, sweeping the floor, walking outside on an icy sidewalk) the subject indicates their level of confidence in doing the activity without losing their balance. For items the subject does not normally perform, they are asked to try and imagine how confident they would feel if they had to do the activity. For subjects who normally use a walking aid to do the specific activity, they are asked to rate their confidence as if they were using these supports. Each item is rated 0-100 for each item. To obtain the final score, the ratings are averaged across the 16 items to produce an overall score from 0-100 with higher scores indicated greater balance confidence.|End of Treatment||||units on a scale||Standard Deviation|Mean
2731564|NCT01006967|Secondary|Change in Dynamic Gait Index From Baseline|"The Dynamic Gait Index (DGI) is another instrument that was developed to assess the likelihood of falling in older adults and tests eight facets of gait. The DGI takes about 15 minutes and requires the following equipment: a Box (Shoebox); 2 Cones; Stairs; and a 20' walkway that is 15 wide. Each item is scored on a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function, resulting in a total score of 0 to 24. The interpretation guidelines state that a score < 19/24 is predictive of falls in the elderly while as score of > 22/24 indicate safe walkers. The outcome reported is the change in the DGI between baseline and end-of-treatment."|End of Treatment||||units on a scale||Standard Deviation|Mean
2731565|NCT01006967|Secondary|Change in Berg Balance Scale From Baseline|The Berg Balance Measure (Berg) was designed to test an elderly patient's level of balance. The test consists of 14 balance items that have been deemed safe for elderly patients to perform. The Berg is a task performance exam that takes about 15 to 20 minutes to complete. The test is scored while it is administered. Each of the independent items are scored on a five point ordinal scale where 0 indicates the patient's inability to perform the task and 4 represents independence; the individual points are then summed to achieve a total score (range 0 - 56). The higher the patient's score on the Berg the more independent the patient. The reported outcome is the change in the Berg between baseline and end of treatment.|End of Treatment||||units on a scale||Standard Deviation|Mean
2731566|NCT01006967|Secondary|Change in Timed Up and Go From Baseline||End of Treatment||||seconds||Standard Deviation|Mean
2731567|NCT01006967|Primary|Number of Subjects Reporting a Fall-related Injury||3 months||||Participants|||Count of Participants
2731568|NCT01006967|Primary|Number of Subjects Reporting Any Fall||3 months||||Participants|||Count of Participants
2731569|NCT01006889|Secondary|Change in Anthropometric Variables (BMI).||6 months|The number of participants included were the ones that completed the study.|||Kg/m2||Standard Deviation|Mean
2731570|NCT01006889|Secondary|Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience).|Change in lipid levels vs. pretreatment.|6 months|Number of patients completing.|||mg/dl||Standard Deviation|Mean
2731571|NCT01006889|Secondary|Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp|M value represents glucose infusion change|6 months|The number of participants included were the ones that completed the study.|||percentage change vs pretreatment||Standard Deviation|Mean
2731572|NCT01006889|Secondary|Insulin Secretion (Hyperglycemic Clamp)|Change in C-peptide levels vs. pretreatment in the first and second phase.|6 months|The number of participants included were the ones that completed the study.|||ng/ml||Standard Deviation|Mean
2731573|NCT01006889|Secondary|Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.||6 months|The number of participants included were the ones that completed the study.|||number of events|||Number
2731574|NCT01006889|Secondary|Change in Anthropometric Variables (Weight).||6 months|The number of participants included were the ones that completed the study.|||Kg||Standard Deviation|Mean
2731575|NCT01006889|Secondary|A1c|Patients with controlled T2DM with bedtime insulin alone (n=5) or bedtime insulin and premeal rapid-acting insulin novolog (n=15) had eventide given twice daily for 6 months (if on premeal insulin it was stopped). The goal is to assess if adding SQ exenatide is effective to maintain optimal glycemic control in this population.|6 months|The number of participants included were the ones that completed the study.|||percentage of A1c||Standard Deviation|Mean
2731576|NCT01006889|Primary|Hepatic Steatosis|Hepatic steatosis was assessed non-invasively by MRS.|6 months|The number of participants included were the ones that completed the study.|||Percentage of liver fat||Standard Deviation|Mean
2731577|NCT01006707|Secondary|Subjective Opioid Withdrawal Scale (SOWS) Score 20 Minutes Following Ondansetron or Placebo Administration|The SOWS consists of 16 physical and emotional symptoms that are rated by the participant on a scale from 0 (not at all) to 4 (extremely), to indicate the extent to which the symptom describes how they are feeling at the time. The total SOWS score is determined by summing the scores of the 16 items. Scores range from a low of 0 to a high of 64. A score of 0 would suggest that the individual is experiencing no symptoms of withdrawal while a score of 64 would suggest that the individual is experiencing all 16 symptoms of withdrawal to the fullest extent possible.|20 minutes following Ondansetron or Placebo administration|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2731578|NCT01006707|Secondary|Objective Opioid Withdrawal Scale Score 15 Minutes Following Ondansetron or Placebo Administration|The OOWS consists of 13 observable physical symptoms that are assessed over a five-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from a low of 0 to a high of 13. A score of 0 would suggest that no objective signs of withdrawal were observed while a score of 13 would suggest that every observable sign of withdrawal was observed.|15 Minutes Following Ondansetron or Placebo Administration|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2731668|NCT01006252|Secondary|Progression Free Survival (PFS)|PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.|Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
2731579|NCT01006707|Secondary|Objective Opioid Withdrawal Scale Score 5 Minutes Following Ondansetron or Placebo Administration|The OOWS consists of 13 observable physical symptoms that are assessed over a five-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from a low of 0 to a high of 13. A score of 0 would suggest that no objective signs of withdrawal were observed while a score of 13 would suggest that every observable sign of withdrawal was observed.|5 Minutes Following Ondansetron or Placebo Administration|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2731580|NCT01006707|Primary|Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration|Changes are reporting using Spearman's correlation coefficient, using within-subject factors of time (pre-naloxone, post-naloxone) and pre-treatment (placebo, ondansetron). Changes in Objective Opioid Withdrawal Scale (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) with correlation coefficient >0.45 are reported. The OOWS consists of 13 observable physical symptoms assessed over a 5-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from 0 to 13; lower scores correspond to fewer symptoms. SOWS consists of 16 physical and emotional symptoms rated by the participant on a scale from 0 (not at all) to 4 (extremely), to indicate the extent to which the symptom describes how they are feeling at the time. The total SOWS score is determined by summing the scores of the 16 items. Scores range from 0 to 64; lower scores correspond to fewer symptoms.|36 minutes||||correlation coefficient|||Number
2731581|NCT01006655|Primary|Adenosine Challenge Test|Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded|ten weeks||||mg/ml||Standard Deviation|Mean
2731582|NCT01006629|Secondary|Total Days of Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
2731583|NCT01006629|Secondary|Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||participants|||Number
2731584|NCT01006629|Secondary|Total Days of RSV ICU Stay|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
2731585|NCT01006629|Secondary|Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization|Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||participants|||Number
2731586|NCT01006629|Secondary|Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
2731587|NCT01006629|Secondary|Total Number of RSV Hospitalization Days|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
2731588|NCT01006629|Primary|Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)|Number of subjects experiencing an RSV hospitalization|Through 30 days following the last injection of palivizumab||||participants||95% Confidence Interval|Number
2731589|NCT01006629|Primary|Frequency of Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.|Through 30 days following the last injection of palivizumab||||participants|||Number
2731590|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Any Type of Infection|The percentage of participants who experienced an AE related to any type of infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.|||Percentage of Participants|||Number
2731591|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Respiratory Infection|The percentage of participants who experienced an AE related to a respiratory infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.|||Percentage of Participants|||Number
2731592|NCT01006616|Secondary|Change From Baseline in Percent of Arterial Oxygen Saturation Measured by Pulse Oximetry Before and After the 6-Minute Walk Test|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. Percent (%) of arterial oxygen saturation, as measured by pulse oximetry, was to be assessed before and after the 6-minute walk test at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test arterial oxygen saturation. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Percent Oxygen Saturation||Standard Error|Least Squares Mean
2731593|NCT01006616|Secondary|Change From Baseline in Pre- and Post-6-Minute-Walk-Test Borg Scale Score|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. The Borg scale is a method use to rate perceived exertion (0=Nothing at all [no exertion] to 10=Maximal [exertion]). Borg scale scores were to be assessed pre- and post-walk-test at Baseline, Week 26, Week 52 and Week 104. A higher score indicates greater perceived exertion.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test Borg scale score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
2731594|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Epithelial Cell-Derived Neutrophil Activating Peptide 78 (ENA-78)|Blood samples were to be collected prior to study drug administration to determine participant plasma ENA-78 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for ENA-78 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||pg/mL||Standard Deviation|Least Squares Mean
2731595|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Plasma Neutrophil Elastase|Blood samples were to be collected prior to study drug administration to determine participant plasma neutrophil elastase levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma neutrophil elastase level. The study was terminated during Period 2; no data were collected for the endpoint at Week 104.|||ng/mL||Standard Deviation|Least Squares Mean
2731596|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Matrix Metallopeptidase-9 (MMP-9)|Blood samples were to be collected prior to study drug administration to determine participant plasma MMP-9 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||ng/mL||Standard Deviation|Least Squares Mean
2731597|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Myeloperoxidase (MPO)|Blood samples were to be collected prior to study drug administration to determine participant plasma MPO levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||ng/mL||Standard Deviation|Least Squares Mean
2731598|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Fibrinogen|Blood samples were to be collected prior to study drug administration to determine participant plasma fibrinogen levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma fibrinogen level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||mg/dL||Standard Deviation|Least Squares Mean
2731599|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: High-sensitivity C-reactive Protein (Hs-CRP)|Blood samples were to be collected prior to study drug administration to determine participant plasma hs-CRP levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma hs-CRP level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||mg/dL||Standard Deviation|Least Squares Mean
2731669|NCT01006252|Primary|Overall Survival (OS)|OS is duration from enrollment to death; OS censored for participants who were alive at last contact.|Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
2731670|NCT01006135|Secondary|Patients With Any Adverse Events||6 months|TS|||Number of participants|||Number
2731600|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Matrix Metallopeptidase-9 (MMP-9)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MMP-9 levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for induced sputum MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||ng/mL||Standard Deviation|Least Squares Mean
2731601|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Sputum Neutrophil Elastase|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. Neutrophil elastase levels were measured in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum neutrophil elastase level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||ng/mL||Standard Deviation|Least Squares Mean
2731602|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Myeloperoxidase (MPO)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MPO levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||ng/mL||Standard Deviation|Least Squares Mean
2731603|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Interleukin 8 (IL-8)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. IL-8 levels were measured by enzyme-linked immunosorbent assay (ELISA) in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum IL-8 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||pg/mL||Standard Deviation|Least Squares Mean
2731604|NCT01006616|Secondary|Change From Baseline in Modified Medical Research Council (MMRC) Dyspnea Score|The MMRC dyspnea scale is used to assess participant breathlessness. The MMRC dyspnea scale consists of five grades that describe almost the entire range of respiratory disability from none (Grade 0=Not troubled with breathlessness except with strenuous exercise) to almost complete incapacity (Grade 4=Too breathless to leave the house or breathless when dressing or undressing). MMRC dyspnea scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for MMRC dyspnea score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
2731605|NCT01006616|Secondary|Change From Baseline in Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index Score|The BODE index is a composite score assessing COPD prognosis that consists of 4 variables that are individually scored: FEV1 percent predicted, 6-Minute Walk Test, Modified Medical Research Council (MMRC) dyspnea scale and body mass index (BMI). The FEV1 percent predicted was scored from ≥65% (0 points, less airway obstruction) to ≤35% (3 points, greater airway obstruction). The 6-Minute Walk Distance was scored from: ≥350 meters (0 points, good exercise capacity) to ≤149 meters (3 points, poor exercise capacity). The MMRC Dyspnea Scale was scored from: MMRC 0: Dyspneic on strenuous exercise (0 points) to MMRC 4: Cannot leave house; breathless on dressing/undressing (3 points). BMI was scored as: >21 (0 points) and ≤21 (1 point). Variable scores were summed to produce a BODE index score. BODE index scores could range from 0 to 10, with a higher score correlating with an increased risk of COPD mortality. BODE index scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for BODE index score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
2731606|NCT01006616|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute with a peak flow meter, is the maximum speed of expiration. Participants were to perform at least 3 and up to 5 PEF measurements in the morning before taking study drug. PEF was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for PEF. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters/minute||Standard Error|Least Squares Mean
2731607|NCT01006616|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC, as measured in liters by body plethysmography, is the maximum amount of air inspired when taking a slow, full inspiration with no hesitation from a position of passive end-tidal expiration (i.e. FRC) to a position of maximal inspiration. IC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for IC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
2731608|NCT01006616|Secondary|Change From Baseline in Total Lung Capacity (TLC)|TLC, as measured in liters by body plethysmography, is the most amount of air lungs can hold at the top of breathing in. TLC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for TLC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
2731609|NCT01006616|Secondary|Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters by body plethysmography, is the volume of air present in the lungs at the end of passive expiration. FRC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FRC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
2731610|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|FVC, as measured in liters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for post-bronchodilator FVC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
2731611|NCT01006616|Secondary|Change From Baseline in Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity (FEF25%-75%) Test|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute by spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. FEF25%-75% was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FEF25%-75%. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters/minute||Standard Error|Least Squares Mean
2731612|NCT01006616|Secondary|Change From Baseline in Pre-bronchodilator FEV1|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Pre-bronchodilator FEV1 was to be assessed immediately before bronchodilator administration at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre-bronchodilator FEV1. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
2731613|NCT01006616|Secondary|Change From Baseline in Distance Walked in 6 Minutes (6-Minute Walk Test)|The 6-minute walk test measures the distance participants can walk quickly on a flat, hard surface in 6 minutes. The 6-minute walk test was to be conducted at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for 6-minute walk test. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Meters||Standard Error|Least Squares Mean
2731614|NCT01006616|Secondary|Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score|The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms (frequency/severity), Activity (limited by breathlessness), Impacts (social functioning, psychological disturbances), and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. The Total score is calculated by summing the weights to all the positive responses in each component, dividing by the sum of weights for all items in the questionnaire, and multiplying this number by 100. SGRQ-C Total scores could range from 0-100, with a higher SGRQ-C Total score indicating greater disease burden. Participants were to assess their COPD symptoms, activity and impact at Baseline, Week 26, Week 52, and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for SGRQ-C score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
2731615|NCT01006616|Secondary|Induced Sputum Absolute Neutrophil Counts|Induced sputum samples were to be obtained from participants via the nebulized method for analysis of absolute neutrophil counts at Week 26, Week 52 and Week 104. The reported Baseline least squares (LS) means and standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a baseline and Week 26, Week 52 or Week 104 assessment for sputum neutrophil count. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||10^9 cells/L||Standard Deviation|Least Squares Mean
2731616|NCT01006616|Secondary|Total Exacerbations of Chronic Pulmonary Disease Tool-Patient-Recorded Outcome (EXACT-PRO) Questionnaire Score|The total score on the EXACT-PRO questionnaire is used to determine the frequency, severity, and duration of exacerbations of COPD. The 14-item EXACT-PRO questionnaire was to be completed by participants every evening to describe their experience of COPD during that day. Assessments were included for Breathlessness (5 items), Cough and Sputum (2 items), Chest Symptoms (3 items), and 4 additional items (Difficulty with Sputum, Tired or Weak, Sleep Disturbance, and Psychological State). Each item was measured on a 5- or 6-point scale. The total EXACT-PRO questionnaire score could range from 0 to 100, with a higher score indicating a more severe health state.|At 26, 52 and 104 weeks|The FAS population was to consist of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for total EXACT-PRO score. This analysis was not conducted if results for percentage of participants with moderate to severe COPD exacerbation suggested no need for further investigation.||||||
2731617|NCT01006616|Secondary|Percentage of Participants With a Moderate to Severe COPD Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The percentages of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26, 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.|||Percentage of Participants|||Number
2731618|NCT01006616|Secondary|Number of Participants With a Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The numbers of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26 , 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.|||Participants|||Number
2731619|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator FEV1 (Period 2)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline, Week 52 and Week 104.|Baseline and Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 52 or Week 104 assessment for post-bronchodilator FEV1 in Period 2. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
2731620|NCT01006616|Primary|Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L|The percentage of participants who experienced an AE related to an ANC of less than 1.5x10^9 cells/L at one or more visits during the first 26 weeks, the first 52 weeks and the first 104 weeks was to be calculated.|Up to 104 weeks|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 52 and up to 104 weeks.|||Percentage of Participants|||Number
2731621|NCT01006616|Primary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline and Week 26.|Baseline and Week 26|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26 assessment for post-bronchodilator FEV1.|||Liters||Standard Error|Least Squares Mean
2731622|NCT01006603|Secondary|Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]|β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||percentage of change from baseline||95% Confidence Interval|Mean
2731623|NCT01006603|Secondary|Change From Baseline to Week 52 in Insulin|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||µU/mL||95% Confidence Interval|Mean
2731624|NCT01006603|Secondary|Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||mmol/L||95% Confidence Interval|Mean
2731625|NCT01006603|Secondary|Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%|Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||percentage of responders|||Number
2731626|NCT01006603|Secondary|Change From Baseline to Week 52 in HbA1c.|Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.|From week 0 to week 52.|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||% of glycosylated hemoglobin||95% Confidence Interval|Mean
2731627|NCT01006603|Secondary|Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.|"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).|||percentage of patients|||Number
2731628|NCT01006603|Primary|Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.|"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.~Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).|||percentage of participants|||Number
2731629|NCT01006590|Secondary|Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta||Baseline and 24 weeks||||Percent (%)||Standard Error|Mean
2731630|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Insulin||Baseline and 24 weeks||||microUnit/milliLiter||Standard Error|Mean
2731631|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose||Baseline and 24 weeks||||millimol/Liter||Standard Error|Mean
2731632|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent|24 Weeks||||Percentage of patients|||Number
2731633|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent|24 Weeks||||Percentage of patients|||Number
2731634|NCT01006590|Primary|Absolute Change From Baseline in HbA1c at Week 24||Baseline and 24 weeks||||Percent (%)||Standard Error|Mean
2731635|NCT01006538|Secondary|Foveal Thickness Measured Using Optical Coherence Tomography (OCT) From Baseline to Month 12||12 months||||μm||Standard Deviation|Mean
2731636|NCT01006538|Secondary|Change in Total Choroidal Neovascular Membrane (CNV) Size by Fluorescein Angiography From Baseline to Month 12||12 months||||mm2||Standard Deviation|Mean
2731637|NCT01006538|Secondary|Change in Total Lesion Size by Fluorescein Angiography From Baseline to Month 12||12 months||||mm2||Standard Deviation|Mean
2731638|NCT01006538|Secondary|Percentage of Subjects Gaining ≥ 15 ETDRS Letters|"Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested.~Participants with an improvement in BCVA by more than 15 EDTRS letters at month 12 compared with baseline were considered for this outcome measure."|12 months||||Participants|||Count of Participants
2731648|NCT01006356|Secondary|Pain Intensity Score|Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.|Day 3 and Day 13|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2731639|NCT01006538|Secondary|Percentage of Subjects Gaining ≥ 0 ETDRS Letters|"Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested.~Participants with an improvement in BCVA by more than 0 EDTRS letters at month 12 compared with baseline were considered for this outcome measure."|12 months||||Participants|||Count of Participants
2731640|NCT01006538|Secondary|Percentage of Subjects Losing < 15 ETDRS Letters|"Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested.~Participants with worsening in BCVA by less than 15 EDTRS letters at month 12 compared with baseline were considered for this outcome measure."|12 months||||Participants|||Count of Participants
2731641|NCT01006538|Primary|Mean Number of Re-treatment Injections of Lucentis® Per Patient, Per Year.||12 months||||injections per patient per year||Standard Deviation|Mean
2731642|NCT01006538|Primary|Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to Month 12|"Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested.~The mean change in ETDRS BCVA was calculated from baseline to month 12."|12 months||||ETDRS Letters||Standard Deviation|Mean
2731643|NCT01006356|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.|Day 1 and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a Scale||Standard Deviation|Mean
2731644|NCT01006356|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.|Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.|||Participants|||Number
2731645|NCT01006356|Secondary|Participant's Preferences Along With Reasons|The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.|Day 15|The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.|||Participants|||Number
2731646|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Participant|Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."|||Participants|||Number
2731647|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Investigator|Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."|||Participants|||Number
2731649|NCT01006356|Secondary|Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15|K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.|Baseline and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.|||Units on a scale||Standard Deviation|Mean
2731650|NCT01006356|Secondary|Frequency of Experiencing Breakthrough Pain|Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.|Day 1 and Day 15|The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.|||Pain episodes per day||Standard Deviation|Mean
2731651|NCT01006356|Primary|Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain|Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).|Day 15|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.|||Percentage of Participants|||Number
2731652|NCT01006291|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group|||Episodes/100 years of patient exposure|||Number
2731653|NCT01006291|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group|||Episodes/100 years of patient exposure|||Number
2731654|NCT01006291|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'. For 28 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2731655|NCT01006291|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2731656|NCT01006252|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2||After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)|The analysis population included all participants who received at least 2 doses of study drug for whom pharmacokinetic data were available. PK analysis were only performed on Tasisulam per protocol.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2731657|NCT01006252|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1||After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)|The analysis population included all participants who received at least 1 dose of study drug for whom PK data were available. PK analysis were only performed on Tasisulam per protocol.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2731658|NCT01006252|Secondary|Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation|EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 4, up to 30 days after treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2731667|NCT01006252|Secondary|Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)|Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions.|First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
2731659|NCT01006252|Secondary|Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation|EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 3, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2731660|NCT01006252|Secondary|Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation|EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 2, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2731661|NCT01006252|Secondary|Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 4, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2731662|NCT01006252|Secondary|Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 3, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2731663|NCT01006252|Secondary|Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 2, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2731664|NCT01006252|Secondary|Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death.|Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||months||95% Confidence Interval|Median
2731665|NCT01006252|Secondary|Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria; PD=20% increase in sum of the longest diameter of target lesions.|First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
2731666|NCT01006252|Secondary|Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed.|First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis per study report.||||||
2731671|NCT01006135|Secondary|Compliance of Patients|Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.|6 months|Patients from FAS|||Number of participants|||Number
2731672|NCT01006135|Secondary|Additional Bronchodilator or Inhaled Corticosteroids (ICS)|Pulmonary medication from baseline to visit 3 (6 months)|6 months|Patients from Full Analysis Set (FAS) which includes all patients from the TS who were assessed after administration of Spiriva, i.e. who have evaluable SGRQ measurements at visit 2 or visit 3.|||Number of participants|||Number
2731673|NCT01006135|Primary|Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline and 6 months|Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)|||Units on a scale||Standard Deviation|Mean
2731674|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState ) Composite Score|CogState had 5 outcome measures that measured the cognitive constructs. GMLT, detection, identification, one card learning and CPAL. GMLT score range: 0 (best) to infinity (worst), detection and identification score range: 2 (best) to 3.3 (worst); One card learning score range: 0 (worse) to 1.57 (best) and CPAL score range: 0 (best) to infinity (worst). The individual score was standardized at each assessment and was then averaged to yield a composite score; total possible score: minus infinity to plus infinity. Positive composite score=improved performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2731675|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||errors||Standard Deviation|Mean
2731676|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Score ranges from 0 (worse) to 1.57 (best). Higher scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||arcsine (square root proportion correct)||Standard Deviation|Mean
2731677|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 msec). Score ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||log10 msec||Standard Deviation|Mean
2731678|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (msec)]. Scores ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||log10 msec||Standard Deviation|Mean
2731679|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 multiplied by 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||errors||Standard Deviation|Mean
2731687|NCT01006122|Secondary|Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase|Cataplexy is a medical condition in which a person suffers sudden physical collapse though remaining conscious. Cataplexy episodes is number of counts the participant had cataplexy.|Baseline, Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||cataplexy episodes||Standard Deviation|Mean
2743922|NCT00925054|Secondary|Number of Participants With Positive PAL IgM Antibody|Antibody positivity over time|Baseline, Week 12|safety population|||Participants|||Count of Participants
2731680|NCT01006122|Other Pre-specified|Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)|Sheehan-STS is an 8-item clinician/participant administered prospective rating scale and an indicator of trigger assessment that tracks both treatment-emergent suicidal ideation and behaviors). Items 1a, 2-6, 8 scored on 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Items 1, 1b, 7, an indicator of trigger assessment (TA) require yes/no response. Items included 1= Ever suffer any accident, 1a= Extent plan/intend to hurt yourself, 1b= Intend to die, 2= Wish dead, 3= Want to harm yourself, 4= Think about suicide, 5= Plan for a suicide, 6= Prepare for suicide (PS) with intent to die (ITD), 7= Injure yourself on purpose, 8= Attempt suicide. Result for item 1 indicates if any of the participant ever suffered any accident, 1b indicates if any of the participant intended to die, 7 indicates if any of the participant injured themselves purposely and trigger assessment indicates if any of the participant evoked trigger assessment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively. Results for a parameter are not reported at certain time points since none of the participants were evaluable for the parameter at those time points.|||participants|||Number
2731681|NCT01006122|Other Pre-specified|Medical Outcomes Study (MOS) Sleep Scale Score|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1(some questions are reversed so that high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range:0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create 7 scale scores and 2 sleep scale index. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), sleep quantity, snoring, awaken short of breath (ASoB), somnolence, sleep adequacy and optimal sleep; and a 9-item overall sleep problems index(SPI) I and II Subscales range from 0-100 except for sleep quantity (SQ) ranging from0 to 24. Except for sleep quantity, higher scores=greater impairment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2731682|NCT01006122|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum Fridericia's correction of QT (QTcF) interval of 450 to <480 msec, 480 to <500 msec and >=500 msec. Number of participants who met the criteria for potential clinical concern in ECG findings were reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
2731683|NCT01006122|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
2731684|NCT01006122|Other Pre-specified|Number of Participants With Vital Signs Data|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (BP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP <50 mmHg, supine and standing heart rate <40 beats per minute (bpm) or >140 bpm. Number of participants who met the criteria for potential clinical concern was reported.|Baseline up to 7-10 days after Day 21 (stable dosing phase)|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
2731685|NCT01006122|Secondary|Clinical Global Impression of Improvement (CGI-I) Scale Score|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: Compared to your subject's condition at the beginning of treatment, how much has your subject changed?. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected."|Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2731686|NCT01006122|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality, social functioning (SF), role emotional (RE) and mental health (MH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2731720|NCT01005888|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=19 C1INH-nf, N=22 placebo).|||mg/dL||Standard Deviation|Mean
2731688|NCT01006122|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|"BFI is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. There are 3 questions that pertain specifically to level of fatigue and 6 questions regarding general activity level, mood and quality of life, all are answered on an 11-point scale, with 0 being No fatigue at all to 10 being As bad as you can imagine. The global score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher global scores are associated with more severe fatigue."|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2731689|NCT01006122|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|ESS is a simple, self-administered questionnaire which provides a measurement of the participant's general level of daytime sleepiness. The participant rates the chance that he/she would fall asleep when in 8 different situations (e.g. sitting and reading, talking to someone, etc.) commonly encountered in daily life on a scale of 0 (no daytime sleep) to 3 (maximum daytime sleep). Total score was the sum of 8 situations ranges from 0 to 24 with a higher score indicating greater daytime sleepiness.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2731690|NCT01006122|Primary|Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase|MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.|Baseline, Day 21 of stable dosing phase|"Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here N(number of participants analyzed) signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm."|||minutes||Standard Deviation|Mean
2731691|NCT01006018|Primary|Insulin Secretion|Not measured as study was prematurely terminated due to unanticipated delays.|baseline, 6 months, 9 months (after a 3 month washout)|||||||
2731692|NCT01005966|Secondary|Change From Baseline in Enamel Fluoride Uptake Potential|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population.|||micrograms (μg)* F/centimeters(cm)^2||Standard Error|Mean
2731693|NCT01005966|Secondary|Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)|SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.|||Percentage SMHR||Standard Error|Mean
2731694|NCT01005966|Primary|Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).|Baseline to 14 days|Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.|||Percentage SMHR||Standard Error|Mean
2731695|NCT01005914|Secondary|Half-life of Pegaspargase||The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.|||||||
2731696|NCT01005914|Secondary|Rate of Minimal Residual Disease|Cycle 1A: Days 1 through 14 Cycle 1B: Days 1 through 8, after the first 14 days of cycle 1A|End of cycles 1A and 1B|||||||
2731697|NCT01005914|Secondary|Overall Survival||At least every 6 months until death.|||||||
2731698|NCT01005914|Secondary|Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2||An interim analysis of safety is planned after the enrollment of 15 evaluable patients.|||||||
2731699|NCT01005914|Secondary|2-year Progression-free Survival||After completion of 8 cycles|||||||
2731700|NCT01005914|Primary|Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.||The assessment of safety will be based mainly on the frequency of adverse events|||||||
2731701|NCT01005914|Primary|Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen|The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.|After day 4 of treatment|Outcome Measure analysis was not performed due to early termination of the study due to safety concerns||||||
2731702|NCT01005901|Secondary|Mean Daily Total Symptom Score Over the 26 Week Treatment Period|"The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement.~Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2731703|NCT01005901|Secondary|Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period|"The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made.~Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.|||percentage of days||Standard Error|Least Squares Mean
2731704|NCT01005901|Secondary|Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period|"The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made.~Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.|||percentage of days with no symptoms||Standard Error|Least Squares Mean
2731705|NCT01005901|Secondary|Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period|"The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made.~Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.|||percentage of nights with no awakenings||Standard Error|Least Squares Mean
2731706|NCT01005901|Secondary|Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period|One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.|||exacerbations per year|||Number
2731707|NCT01005901|Secondary|Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|26 Weeks and 30 Day follow-up|The safety set included all patients who received at least one dose of study medication whether or not being randomized. Patients were randomized according to the treatment they received.|||participants|||Number
2731708|NCT01005901|Secondary|Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26|The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.|Baseline, Day 1, Week 12 and Week 26|"The safety set included all patients who received at least one dose of study medication whether or not being randomized. A sub-set of the safety population had 24 hour Holter monitoring. n indicates patients with observations both at baseline and each endpoint."|||beats per minute||Standard Deviation|Mean
2731709|NCT01005901|Secondary|Trough FEV1 and FVC at Day 1 and Week 26|"Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.~Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. If one of the 23 h 15 min or 23 h 45 min values are missing then the remaining non-missing value is taken as trough FEV1 or trough FVC. If both values are missing, then their trough FEV1 or trough FVC is regarded as missing|||Liters||Standard Error|Least Squares Mean
2731710|NCT01005901|Secondary|FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Week 12 and Week 26|Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed.|||Liters||Standard Error|Least Squares Mean
2731711|NCT01005901|Secondary|FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1, Week 12 and Week 26|"Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed. n is the number of patients with non-missing observations at each time point."|||Liters||Standard Error|Least Squares Mean
2731712|NCT01005901|Secondary|Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point.|||Liters||Standard Error|Least Squares Mean
2731713|NCT01005901|Secondary|FEV1 at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point|||Liters||Standard Error|Least Squares Mean
2731714|NCT01005901|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients with observations both at baseline and week 26 were included in this analysis|||Puffs per day||Standard Error|Least Squares Mean
2731715|NCT01005901|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment|The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|"Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.~The median values were not estimable."|||Days||95% Confidence Interval|Median
2731716|NCT01005901|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Individual component score was imputed with LOCF (last observation carried forward).|||Units on a scale||Standard Error|Least Squares Mean
2731717|NCT01005901|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients per treatment group with no missing data were included in this analysis.|||Units on a scale||Standard Error|Least Squares Mean
2731718|NCT01005901|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|12 weeks|Full Analysis Set (FAS) The FAS included all randomized patients who received at least one dose of study medication. Patients in this group were analyzed according to the treatment to which they were randomized. Missing trough FEV1 values at week 12 were imputed using LOCF with pre-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2731719|NCT01005888|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=20 C1INH-nf, N=22 placebo).|||percent of functional C1INH||Standard Deviation|Mean
2731721|NCT01005888|Other Pre-specified|Total Number of Days of Swelling During Each Prophylactic Therapy Period|A day of swelling was defined as a day that a subject reported swelling at any of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity).|12 weeks|Efficacy Dataset.|||days||Standard Deviation|Mean
2731722|NCT01005888|Secondary|Number of Open-label C1INH-nf Infusions Required During Each Prophylactic Therapy Period|The study design allowed for subjects to be treated with open-label C1INH-nf for laryngeal angioedema, if deemed necessary by the investigator, or prior to emergency surgical procedures.|12 weeks|Efficacy Dataset.|||infusions||Standard Deviation|Mean
2731723|NCT01005888|Secondary|Average Duration of HAE Attacks During Each Prophylactic Therapy Period|"The duration of an attack was measured from the first report of swelling at any one of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity) until the first subsequent report of no swelling at all five locations."|12 weeks|Efficacy Dataset.|||days||Standard Deviation|Mean
2731724|NCT01005888|Secondary|Average Severity of HAE Attacks During Each Prophylactic Therapy Period|All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the subject to any swelling location during the attack. Average severity was set to 0 if there was no attack in a period.|12 weeks|Efficacy Dataset.|||units on a scale||Standard Deviation|Mean
2731725|NCT01005888|Secondary|Number of Subject Withdrawals During Each Prophylactic Therapy Period|At the end of each therapy period, each subject was assigned a yes/no drop-out status. A drop-out was defined as a subject who did not have a Week 12 visit record.|12 weeks|The Safety Dataset (N=24) consisted of all randomized subjects who received at least 1 complete or partial infusion of study drug. 24 subjects began Period 1 (12 C1INH-nf, 12 placebo) and received study drug. 22 subjects crossed over to Period 2 (11 placebo, 11 C1INH-nf) and received study drug. Thus, 23 randomized subjects received each therapy.|||participants|||Number
2731726|NCT01005888|Primary|Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period|An HAE attack was defined as the subject-reported indication of swelling at any location following a report of no swelling on the previous day. Analyses include observed attack counts and normalized attack counts (i.e., the number of attacks observed during each therapy period, normalized for the number of days the subject participated in that period).|12 weeks|The Efficacy Dataset (N=22) consisted of all randomized subjects who completed 12 weeks of therapy in Period 1 and received at least one infusion of study drug in Period 2.|||attacks||Standard Deviation|Mean
2731727|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).|the measured ADC at baseline, 4 weeks after baseline and then 10 weeks after baseline. ADC quantifies the motion of water protons from an MRI.|baseline, 4 weeks post baseline, 10 weeks post baseline||||milimeters^2/sec||Standard Deviation|Mean
2731728|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.|The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.|baseline, 4 weeks after baseline and 10 weeks post baseline||||Min^ -1||Standard Deviation|Mean
2731729|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).|The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.|baseline, 4 weeks and 10 weeks||||min^ -1||Standard Deviation|Mean
2731730|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume|mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment|baseline, 4 weeks and 10 weeks||||centimeters^3||Standard Deviation|Mean
2731731|NCT01005875|Primary|Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma|Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib|between baseline and 3 years||||participants|||Number
2731732|NCT01005810|Primary|Percentage of Negative Urine Cannabinoid Tests During Treatment|[Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100|weekly during treatment, for 8 weeks||||percentage of negative urine tests|||Number
2731733|NCT01005745|Secondary|Number of Participants With Objective Response (OR)|OR is defined as the patient being alive at Day 70 and tumor size evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response or partial response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Evaluations were made by computed tomography (CT) scan approximately 6 to 8 weeks after the cell infusion, or CT scan approximately 10 weeks after the cell infusion, or by clinical evaluation during the first 70 days.|Average of 10 Months Follow-up|All participants who completed treatment|||participants|||Number
2731734|NCT01005745|Primary|Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth|Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.|192 Days Post Surgical Resection|All participants|||participants|||Number
2731735|NCT01005732|Secondary|Compliance With Wearing Compression Garment|The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.|About 12 months (follow-up visit 5)|All Participants with available and evaluable data.|||hours per day||Standard Deviation|Mean
2731750|NCT01005719|Secondary|Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 4 for at least 12 hrs at~steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
2731751|NCT01005719|Secondary|Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7||Treatment dose to 24-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
2731736|NCT01005732|Secondary|Clinical Appearance of Wound|"Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or no difference) that the indicated zone had the better appearance."|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.|||Participants|||Number
2731737|NCT01005732|Secondary|Thickness of Wound|Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.|||mm||Standard Deviation|Mean
2731738|NCT01005732|Secondary|Color of Wound|A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L*a*b* color space was described by The Commission Internationale de I'Eclairage (CIE)(L=brightness [100=white,0=black], a=red-green[red=60,green=-60], b=yellow-blue[yellow=60,blue=-60])|Approximately12 months (follow-up visits 5)|All Participants with available and evaluable measurement.|||color space parameter units|Participants|Standard Deviation|Mean
2731739|NCT01005732|Secondary|Durometer (Hardness) of Wound|"A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in durometer units (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm."|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.|||durometer units||Standard Deviation|Mean
2731740|NCT01005732|Primary|Pressure Under Compression Garment|Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits.|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.|||mm Hg||Standard Deviation|Mean
2731741|NCT01005719|Secondary|Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing|"The earliest time during the first 4 hours after dosing that the median~pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.)"|Treatment dose to event on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Minutes||Full Range|Median
2731742|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1||Treatment dose to 4-hours post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
2731743|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1||Treatment dose to 24-hour post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
2731744|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
2731745|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
2731746|NCT01005719|Secondary|Time to Onset of Inhibition of Acid Secretion on Day 1|The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed.|Treatment dose to onset of event on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Minutes||Full Range|Median
2731747|NCT01005719|Secondary|Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7|The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed.|Treatment dose to 2-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Minutes||Full Range|Median
2731748|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
2731749|NCT01005719|Secondary|Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at~steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
2731752|NCT01005719|Secondary|Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of time||Full Range|Median
2731754|NCT01005719|Secondary|Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7||Treatment dose to 4 hours Post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of time||Full Range|Median
2731755|NCT01005719|Secondary|Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period|The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of study treatment, and did not have missing values.|||Minutes||Full Range|Median
2731756|NCT01005719|Secondary|The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||pH||Full Range|Median
2731757|NCT01005719|Secondary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||pH||Full Range|Median
2731758|NCT01005719|Primary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 7|Participants who received at least one dose of study treatment, and did not have missing values.|||pH||Full Range|Median
2731759|NCT01005706|Primary|Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection|Number of Participants with Kidney Rejections|12 months||||participants|||Number
2731760|NCT01005680|Other Pre-specified|Survival Without Toxicity (SWT)|SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.|Randomization to date of toxicity or date of death up to 34.6 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10.|||months||95% Confidence Interval|Median
2731761|NCT01005680|Other Pre-specified|Disease Control Rate (DCR)|DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy.|||percentage of participants|||Number
2731762|NCT01005680|Secondary|Risk/Benefit Ratio|Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.|Randomization to date of death from any cause up to 35.8 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle.|||ratio|||Number
2731763|NCT01005680|Secondary|Tumor Response Rate|Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.|Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy.|||percentage of participants|||Number
2731799|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
2731764|NCT01005680|Secondary|Time to Treatment Failure (TtTF)|TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.|Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91.|||months||95% Confidence Interval|Median
2731765|NCT01005680|Secondary|Duration of Response (DoR)|DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions|Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0.|||months||95% Confidence Interval|Median
2731766|NCT01005680|Secondary|Time to Progressive Disease (TtPD)|TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.|Randomization to first date of PD up to 23.7 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19.|||months||95% Confidence Interval|Median
2731767|NCT01005680|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.|Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization|Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10.|||months||95% Confidence Interval|Median
2731768|NCT01005680|Primary|Overall Survival (OS)|OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.|Randomization to date of death from any cause up to 35.8 months post-randomization|Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39.|||months||95% Confidence Interval|Median
2731769|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP G2677T/A|Serum digoxin concentration by ABCB1 SNP genotypes|Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
2731770|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP C3435T|Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T|Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
2731771|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T|55 patients in the Digoxin Dosing per Nomogram group consented to the Pharmacogenetic substudy and provided blood samples to perform pharmacogenetic analyses. We compared serum digoxin concentrations by ABCB1 genotype.|Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
2731772|NCT01005602|Secondary|Serum Digoxin Concentration < 1.0 ng/ml||Steady-state (2 - 4 weeks after initiation)||||percentage of participants|||Number
2731773|NCT01005602|Secondary|Mean Serum Digoxin Concentration||Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
2731774|NCT01005602|Primary|Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml||Steady-state (2 - 4 weeks after initiation)||||percentage of participants|||Number
2731775|NCT01005576|Secondary|Incidence of Disease Recurrence||2 years||||Participants|||Count of Participants
2731776|NCT01005576|Secondary|Median Time to Platelet Engraftment||100 days|3 participants did not engraft platelets|||days||Full Range|Median
2731777|NCT01005576|Secondary|Median Time to ANC Engraftment||100 days||||days||Full Range|Median
2731778|NCT01005576|Secondary|Development of Graft Versus Host Disease (GVHD)||2 years||||Participants|||Count of Participants
2731779|NCT01005576|Primary|Primary Objective: Event-free Survival at 1 Year.||1 year||||Participants|||Count of Participants
2731780|NCT01005459|Primary|Spinal Analgesic Duration|duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete|1-2 hrs||||minutes||Standard Deviation|Mean
2731781|NCT01005407|Secondary|Percentage of Participants With Local and Systemic Reaction to Injections||within 7 days for post-injection reactions|Safety population: All participants who received at least 1 study injection and had at least 1 post-baseline safety data. NOTE: Only subjects with non-missing injection results in the Safety population are included in this analysis.|||percentage of participants|||Number
2731782|NCT01005407|Primary|Percentage of Subjects Who Have a Seroprotective Immune Response|Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®|at Week 12 and at Week 32|Non-Inferiority per Protocol population:Randomized subjects who received 1 of 3 consistency lots of HEPLISAV or Engerix-B within the study visit windows, had all 3 study injections as randomized and within the study visit windows, no major protocol deviations, and anti-HBs levels obtained within study visit windows at baseline, Week 12, and Week 32|||Percentage of participants|||Number
2731783|NCT01005355|Secondary|Screen for the Development of Circulating Antibodies Against IMC-1121B (Immunogenicity)|Data presented are the number of participants with treatment emergent antibody positive.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.|||participants|||Number
2731784|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour post-dose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731785|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 1 and 2||Day 1 and Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.|||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
2731786|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731787|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.|||hours||Full Range|Median
2731788|NCT01005355|Primary|IMC-1121B Pharmacokinetics - Area Under the Concentration (AUC) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731789|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohort 3 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
2731790|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731791|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
2731792|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731793|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.|||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
2731794|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731795|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.|||hours||Full Range|Median
2731796|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2731797|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) Versus Time Curve - Cohorts 1 and 2 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
2731798|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
2739115|NCT00957359|Primary|HADS Depression|Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)|1 day post drug administration 2||||score on a scale||Standard Error|Mean
2731800|NCT01005355|Primary|Number of Participants With Drug-Related Adverse Events|Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.|||participants|||Number
2731801|NCT01005329|Secondary|Distant Failure (Two-year Rate Reported)|Distant Failure (DF) was defined as the appearance of distant metastasis. Death was considered a competing risk. DF rates were estimated using the cumulative incidence method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Median
2731802|NCT01005329|Secondary|Pelvic Failure Rate (Two-year Rate Reported)|Pelvic failure (PF) was defined as disease recurrence in the pelvis, including the pelvic or sacral lymph nodes, and required confirmation by histologic or cytologic biopsy of the recurrent lesion. Death was considered a competing risk. PF rates were estimated using the cumulative incidence method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2731803|NCT01005329|Secondary|Disease-free Survival (Two-year Rate Reported)|Failure was defined as pelvic failure (recurrence in the pelvis, which must be confirmed by histologic or cytologic biopsy of the recurrent lesion), distant failure (confirmed by histologic or cytologic biopsy of the recurrent lesion), or death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Disease-free survival rate at two years was estimated using the Kaplan-Meier method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2731804|NCT01005329|Secondary|Overall Survival (Two-year Rate Reported)|Failure was defined as death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Survival rate at two years was estimated using the Kaplan-Meier method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2731805|NCT01005329|Secondary|Treatment-related Grade 3+ Adverse Events|The highest grade adverse event per patient reported as definitely, probably, or possibly related to study treatment is counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.|Eligible patients who started treatment|||Participants|||Count of Participants
2731806|NCT01005329|Secondary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events reported as definitely, probably, or possibly related to study treatment.|From start of treatment to one year|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2731807|NCT01005329|Primary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to 90 days|Eligible patients who started study treatment|||percentage of participants||90% Confidence Interval|Number
2731808|NCT01005316|Secondary|Time to Acute Rejection|Time (in days) to acute rejection. Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). Time to acute rejection is time from transplantation to first acute rejection date.|Transplantation to the end of study.|Transplanted Participants|||Days||Full Range|Mean
2731809|NCT01005316|Secondary|Percentage of Participants Experiencing Acute Rejection|Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT)) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression).|Transplantation to the end of study.|Transplanted Participants|||percentage of participants|||Number
2731810|NCT01005316|Secondary|Time to New-Onset Diabetes Mellitus|Time (in days) to new-onset diabetes mellitus. New-onset diabetes mellitus is defined as the new onset of insulin dependency or the need for oral hypoglycemic agents lasting more than 30 days post-transplant. Time to new-onset diabetes is time from transplantation until the diagnosis of new-onset diabetes.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants. Note to provide relevant outcome measure perspective -Of the overall number of participants analyzed, the number of new onset diabetes mellitus cases diagnosed within groups were: Cohort A: Non-Sensitized (N=1); Cohort B: Sensitized, Crossmatch Positive (N=2); and Cohort B: Sensitized, Crossmatch Negative (N=7).|||Days||Full Range|Mean
2731811|NCT01005316|Secondary|Time to Post-Transplantation Lymphoproliferative Disorder|Time (in days) post-transplant lymphoproliferative disorder (PTLD). PTLD is defined as histopathological evidence of lymphoid proliferation (nodal or extranodal) fulfilling the criteria of the revised classification of the WHO 2008 (Swerdlow 2008). Time to PTLD is time from transplantation until the diagnosis of PTLD.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants. Note to provide relevant outcome measure perspective- Of the overall number of participants analyzed, the number of diagnosed PTLD cases within groups were: Cohort A: Non-Sensitized (N=1); Cohort B: Sensitized, Crossmatch Positive (N=0); and Cohort B: Sensitized, Crossmatch Negative (N=3).|||Days||Full Range|Mean
2731812|NCT01005316|Secondary|Time to Diagnosis of Chronic Rejection|Time (in days) to the diagnosis of chronic rejection. Chronic rejection is defined as stenosis, irregularity, or ectasia of the epicardial vessels, or severe peripheral pruning of the distal coronary artery tree. Time to diagnosis is time from transplantation until the first diagnosis of chronic rejection.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||Days||Full Range|Mean
2731813|NCT01005316|Secondary|Percentage of Participants Positive for Severe Infection(s)|Severe infections are defined as a clinical illness considered likely infectious in origin that leads to hospitalization.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
2731814|NCT01005316|Secondary|Percentage of Participants With Occurrence of Re-Hospitalization(s)|Hospitalization is defined as any hospitalization lasting greater than 24 hours.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
2731815|NCT01005316|Secondary|Presence of C4d on Endomyocardial Biopsy (EMB)|The biopsy of the heart stained positive for the presence of C4d, a potential marker of rejection.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
2731816|NCT01005316|Secondary|Percentage of Participants -Overall Participant and Graft Survival|This measure looks at the participants who did not die and/or did not receive a subsequent heart transplant.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
2731817|NCT01005316|Secondary|Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay|Major histocompatibility complex class I chain-related gene A (MICA) is an antigen that is a potential marker of rejection. Luminex TM assay was used to detect its presence.|Pre-Transplantation|Transplanted Participants|||percentage of participants|||Number
2731818|NCT01005316|Secondary|Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing|Quantification of anti-HLA IgG antibodies is measured in mean fluorescence intensity (MFI). The maximum MFI for the given subject is provided.|Pre-transplantation|Transplanted Participants|||percentage of participants|||Number
2731819|NCT01005316|Secondary|Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing|Luminex SA testing was used to detect the presence of anti-HLA IgG Antibodies for all samples at a central laboratory.|Pre-transplantation|Transplanted Participants|||percentage of participants|||Number
2731820|NCT01005316|Secondary|Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing|Time (in days) from listing on the organ wait-list to receiving an organ transplant, death or de-listing. This measure is calculated as time from listing on the organ wait-list until the earliest time among transplantation, death and de-listing.|Study enrollment to transplantation|Enrolled participants who died, were transplanted or de-listed.|||Days||Full Range|Mean
2731821|NCT01005316|Secondary|Percentage of Participants- Mortality While on Transplantation Wait-List|Death that occurred while on the transplantation wait-list, and thus before receiving a heart transplant.|Pre-transplantation|Participants Enrolled, Not Transplanted|||percentage of participants|||Number
2731822|NCT01005316|Secondary|Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation|A de novo donor-specific alloantibody (DSA) is a newly developed alloantibody that is against the donor organ. This measure includes all de novo DSA (≥1000 MFI) regardless of is persistence or timing within the first year post-transplant. Alloantibodies are important mediators of acute and chronic rejection.|Transplantation to first year post transplant (up to 12 months post transplant).|Transplanted Participants|||percentage of participants|||Number
2731823|NCT01005316|Secondary|Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies|Time (in days) from transplant to development of de novo donor-specific alloantibodies (DSA). This measure is calculated as time from transplant until the earliest time of development of any de novo DSA. The DSA is a newly developed alloantibody that is against the donor organ. Alloantibodies are important mediators of acute and chronic rejection.|Transplantation to first year post transplant (up to 12 months post transplant).|Transplanted Participants|||Days||Full Range|Mean
2731824|NCT01005316|Primary|Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation|"This is a composite outcome of death, graft loss or rejection with hemodynamic compromise.~Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure."|12 months post-transplantation|Transplanted Participants|||percentage of participants|||Number
2731825|NCT01005290|Secondary|Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period|Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.|||mm Hg||Standard Deviation|Mean
2731840|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to Skin Change|No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=27 participants with non-missing data.|||days||Full Range|Median
2731826|NCT01005290|Primary|Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.|Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.|||mm Hg||Standard Deviation|Mean
2731827|NCT01005251|Secondary|Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary~(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment||||Percent||Inter-Quartile Range|Median
2731828|NCT01005251|Primary|Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.~(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment||||Participants|||Number
2731829|NCT01004991|Primary|Complete Response|Complete Response|13 months||||Participants|||Count of Participants
2731830|NCT01004939|Secondary|Duration From Start of Fondaparinux Therapy to HIT|For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only one participant developed HIT after receiving Fondaparinux; thus, rather than presenting median data, data are presented as the number of days from start of therapy to HIT.|||days|||Number
2731831|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy|The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731832|NCT01004939|Secondary|Number of Participants With Skin Changes Under Fondaparinux Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731833|NCT01004939|Secondary|Number of Participants With Bleedings Under Fondaparinux Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731834|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under Fondaparinux Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731835|NCT01004939|Secondary|Number of Participants With and Without Complications Under Fondaparinux Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731836|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to HIT||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=8 participants with non-missing data.|||days||Full Range|Median
2731837|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy|HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731838|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy|Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.|||participants|||Number
2731839|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy|Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.|||participants|||Number
2731940|NCT01004393|Secondary|Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||units on a scale||Standard Deviation|Mean
2731841|NCT01004939|Secondary|Number of Participants With Skin Changes Under UFH/LMWH Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731842|NCT01004939|Secondary|Number of Participants With Bleedings Under UFH/LMWH Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731843|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under UFH/LMWH Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731844|NCT01004939|Secondary|Number of Participants With Complications Under UFH/LMWH Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731845|NCT01004939|Secondary|Duration of Hospitalizations Before, During, and After Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=3 participants (before Fondaparinux), n=5 participants (during Fondaparinux), and n=1 participant (after Fondaparinux) with non-missing data.|||days||Full Range|Median
2731846|NCT01004939|Secondary|Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=9 participants with non-missing data.|||days||Full Range|Median
2731847|NCT01004939|Secondary|Number of Participants Hospitalized Because of Thromboembolic Treatment|Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731848|NCT01004939|Primary|Number of Newborns With Abnormalities|No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||newborns|Participants||Number
2731849|NCT01004939|Primary|"Number of Newborns Who Had a Healthy Postnatal Classification"|"A healthy documentation was based on the investigators' individual assessment."|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins.|||newborns|Participants||Number
2731850|NCT01004939|Primary|Mean APGAR Score at 1, 5, and 10 Minutes After Birth|APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=26 (1 min) or n=27 (5 and 10 min) newborns with non-missing data.|||scores on a scale|Participants|Standard Deviation|Mean
2731851|NCT01004939|Primary|Mean Head Circumference of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=27 newborns with non-missing data.|||centimeters|Participants|Standard Deviation|Mean
2731852|NCT01004939|Primary|Mean Height of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=37 newborns with non-missing data.|||centimeters|Participants|Standard Deviation|Mean
2731853|NCT01004939|Primary|Mean Weight of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=63 newborns with non-missing data.|||grams|Participants|Standard Deviation|Mean
2731854|NCT01004939|Primary|Number of Participants Who Delivered a Single Child Versus Twins||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731855|NCT01004939|Primary|Number of Participants With the Indicated Type of Conception/Fertilization||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731941|NCT01004393|Secondary|Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||units on a scale||Standard Deviation|Mean
2731856|NCT01004939|Primary|Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731857|NCT01004939|Primary|Number of Participants With the Indicated Reason for the End of Fondaparinux Administration|It is possible that a participant stopped receiving Fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731858|NCT01004939|Primary|Number of Hours After Birth at Which Fondaparinux Administration Was Restarted||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=86 participants with non-missing data.|||hours||Standard Deviation|Mean
2731859|NCT01004939|Primary|Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=45 participants with non-missing data.|||hours||Standard Deviation|Mean
2731860|NCT01004939|Primary|Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731861|NCT01004939|Primary|Duration of Postnatal Fondaparinux Administration|The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=90 participants with non-missing data.|||days||Full Range|Median
2731862|NCT01004939|Primary|Duration of Prenatal Fondaparinux Administration|The prenatal interval is defined as the interval of time until 3 days before birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=99 participants with non-missing data.|||days||Full Range|Median
2731863|NCT01004939|Primary|Duration of Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=101 participants with non-missing data.|||days||Full Range|Median
2731864|NCT01004939|Primary|Number of Participants Administered the Indicated Dose of Fondaparinux Per Day||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731865|NCT01004939|Primary|Number of Participants With the Indicated Reason for Change to Fondaparinux|It was possible for a participant to have changed to fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731866|NCT01004939|Primary|Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals|The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
2731867|NCT01004874|Secondary|Median Progression-free Survival|PFS was defined as time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat|||months||95% Confidence Interval|Median
2731868|NCT01004874|Secondary|Number of Patients Experiencing a Greater Than or Equal to Grade 4 Hematologic or a Greater Than or Equal to Grade 3 Non-hematologic Toxicity|Number of times a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity was experienced|27 months|Intent to treat|||participants|||Number
2731869|NCT01004874|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|27 months|Intent to treat|||participants|||Number
2731870|NCT01004874|Secondary|Median Overall Survival|OS was defined as time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat|||months||95% Confidence Interval|Median
2731871|NCT01004874|Secondary|One and Two Year Overall Survival|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date.|One year and two years|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2731872|NCT01004874|Primary|6-month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2731935|NCT01004406|Secondary|Change in % Necrotic Core (NC) Component of Atheroma From Baseline to 12 Weeks Post-PCI as Assessed Via IVUS-VH|The %NC component of atheroma were obtained via IVUS-VH at 2 time points (baseline during index PCI and 12-week follow-up).|baseline and 12-week follow-up|Reported results are based on ITT approach.|||percentage of atheroma component||Standard Deviation|Mean
2731942|NCT01004393|Secondary|Time to Laxation After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||hours||Standard Error|Mean
2731873|NCT01004861|Primary|Numeric Rating Scale (NRS) for PVNS Symptoms Sum of Scores Through Cycle 2 (Efficacy Evaluable Population) - Dose Extension|"The NRS for PVNS Symptoms instrument is a 5-item self-administered questionnaire to assess the worst of each of the symptoms pain, swelling, stiffness, instability and limited motion in the last 24 hours. A 0 to 10 NRS is provided for each symptom. For pain, 0 indicates no pain and 10 indicates pain as bad as you can imagine. For the other 4 symptoms, 0 indicates no (symptom) and 10 indicates (symptom) worst imaginable, e.g., swelling - worst imaginable. Higher scores indicated worse outcome."|Baseline, Cycle 1 Day 15, Cycle 2, Cycle 3, Cycle 12, Cycle 24, and Cycle 36|NRS for PVNS symptoms were assessed in the Efficacy Evaluable Population.|||units on a scale||Standard Deviation|Mean
2731874|NCT01004861|Primary|Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Area Under the Curve (AUC0-24), Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation|Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing, predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.|Cycle 1, Day 15 (QD dosing: predose [morning] and 0.5, 1, 2, 4, and 8 hours postdose; BID dosing: predose [morning] and 1, 2, 4, and 7 hours postdose)|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng*hr/mL||Full Range|Median
2731875|NCT01004861|Primary|Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Tmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation|Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.|Cycle 1, Day 15|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||hour||Full Range|Median
2731876|NCT01004861|Primary|Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Cmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation|Cycle 1 Day 15 pharmacokinetic (PK) timepoints taken are: For once daily (QD) dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For twice a day (BID) dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.|Cycle 1, Day 15|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng/mL||Full Range|Median
2731877|NCT01004861|Primary|Best Overall Tumor Response (PVNS Cohort) Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension|"Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE).~RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 2 months beginning Cycle 3, Day 1 until disease progression|Best overall tumor response was assessed in the Efficacy Evaluable Population.|||Participants|||Count of Participants
2731878|NCT01004861|Primary|Progression-free Survival (Efficacy Evaluable Population) - Dose Extension|Progression-Free Survival (PFS) is defined as the number of days from the first day of treatment to the first documented disease progression or date of death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, PFS is censored at the date of last evaluable tumor assessment.|From Cycle 1 Day 1 to disease progression or death|Progression-free survival was assessed in the Efficacy Evaluable Population.|||days||95% Confidence Interval|Median
2731879|NCT01004861|Primary|Duration of Response (Efficacy Evaluable Population) - Dose Extension|Duration of Response (DOR) is defined as the number of days from the date of initial response (CR or PR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, DOR is censored as of the date of their last imaging exam of target or non-target lesions prior to post-surgery and/or off-treatment scans.|From initial response until disease progression or death, up to approximately 30 months postdose|Duration of response was assessed among participants with response of CR or PR in the Efficacy Evaluable Population.|||days||95% Confidence Interval|Median
2731880|NCT01004861|Primary|Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension (Efficacy Evaluable Population)|"Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE).~RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose)|Best overall tumor response was assessed in the Efficacy Evaluable Population.|||Participants|||Count of Participants
2731943|NCT01004393|Secondary|Laxation After Administration of Subcutaneous Methylnaltrexone||24 and 48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
2731944|NCT01004393|Primary|Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone||4 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
2731881|NCT01004861|Primary|Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population)|"Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE).~RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose)|Best overall tumor response was assessed in the Efficacy Evaluable Population.|||Participants|||Count of Participants
2731882|NCT01004848|Secondary|Knowledge & Attitudes About Diabetes Risk||6 months|||||||
2731883|NCT01004848|Secondary|Physical Activity (Self-report)||6 months|||||||
2731884|NCT01004848|Secondary|Fiber Intake||Change from Baseline to 6 Months||||grams per day||Standard Deviation|Mean
2731885|NCT01004848|Secondary|Energy Expenditure|percent energy expenditure|Change from Baseline to 6 Months||||percent expenditure/day||Standard Deviation|Mean
2731886|NCT01004848|Secondary|HbA1c||Change from Baseline to 6 Months||||percent change||Standard Deviation|Mean
2731887|NCT01004848|Secondary|Triglycerides||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
2731888|NCT01004848|Secondary|Total Cholesterol||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
2731889|NCT01004848|Secondary|HDL Cholesterol||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
2731890|NCT01004848|Secondary|LDL Cholesterol||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
2731891|NCT01004848|Secondary|Waist Circumference||Change from Baseline to 6 Months||||inches||Standard Deviation|Mean
2731892|NCT01004848|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months||||mmHg||Standard Deviation|Mean
2731893|NCT01004848|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months||||mmHg||Standard Deviation|Mean
2731894|NCT01004848|Secondary|Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months|Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline|Change in 6 Months from Baseline||||mg/dL||Standard Deviation|Mean
2731895|NCT01004848|Secondary|Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months|Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline|Change from Baseline to 6 Months||||mg/dL||Standard Deviation|Mean
2731896|NCT01004848|Primary|Change in Weight From Baseline to 6 Months||Change from Baseline to 6 Months||||pounds||Standard Deviation|Mean
2731897|NCT01004822|Secondary|Participants With Reduction in Tumor Vascular Permeability: Blood Flow and Blood Volume as Measured by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI is a non-invasive method that provides a functional assessment of microvasculature. The technique can measure changes in vascular permeability, extracellular, and extravascular and vascular volumes. Based on its ability to detect vascular changes, DCE-MRI has recently been evaluated as a biomarker of drug efficacy in clinical trials of angiogenesis inhibitors. Assessment of DCE-MRI started at the 3.0 mg/kg dose cohort.|Stage 2 predose up to end of study|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.||||||
2731898|NCT01004822|Secondary|Participants WithTumor Response of CA-125 Epithelial Ovarian Cancer (EOC)/ Primary Peritoneal Cancer (PPC)|Participants with epithelial ovarian cancer or primary peritoneal cancer having CA-125 levels greater than 2x the upper limit of normal, 2 weeks prior to starting therapy were evaluated for CA-125 response and response is defined as a 50% decrease in CA-125 from a pre-treatment sample. The response was confirmed and maintained for at least 28 days. CA-125 response was calculated as intervening samples and the 28-day confirmatory sample must be less than or equal to (within assay variability of 10%) the previous sample Progression or recurrence based on serum CA-125 is defined according to the participants baseline levels.|Stage 2 every cycle|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.||||||
2731899|NCT01004822|Secondary|Objective Response Rate - Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and Progressive Disease.|Every 8 weeks from start of treatment until last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||percentage of participants|||Number
2731900|NCT01004822|Secondary|Number of Anti Drug Antibody Samples With Positive Anti-CVX-241 Antibodies|Results were summarized for overall study population as per planned analysis.|Day 1 pre-dose of each cycle up to last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||samples|||Number
2731945|NCT01004354|Secondary|Leptin at Baseline and Post-treatment||Baseline and 8 weeks||||ng/mL||Standard Deviation|Mean
2731946|NCT01004354|Secondary|Adiponectin at Baseline and Post-treatment||Baseline and 8 weeks||||mcg/mL||Standard Deviation|Mean
2731901|NCT01004822|Secondary|Change From Baseline in Serum Angiopoietin-2 (Ang2) Concentrations|Angiopoietin-2 (Ang2) and a related protein, angiopoietin-1 (Ang1) are ligands of the endothelial cell receptor Tie-2, a receptor tyrosine kinase, and are known to mediate the angiogenesis process together with VEGF and other angiogenic regulators. Ang1 stimulates the phosporylation of Tie-2, recruits pericytes to newly formed blood vessels, and promotes their maturation. Ang2 competes with Ang1 for binding of Tie-2, promotes the dissociation of pericytes, and results in unstable blood vessels. In the presence of VEGF and other angiogenic factors, endothelial cells in these unstable vessels proliferate and migrate to form new blood vessels.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||pg/mL||Standard Deviation|Mean
2731902|NCT01004822|Secondary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentrations|VEGF family consists of five glycoproteins known as VEGF-A, -B, -C, and -D, and placental growth factor (PlGF), which bind to three structurally similar receptor tyrosine kinases VEGFR1, VEGFR2, and VEGFR3. The different ligands have distinctive binding specificities for each of the receptors. In response to ligand binding, the VEGFRs activate distinct downstream signalling pathways. VEGFR2 is expressed in the vasculature and is the key mediator of VEGF-induced angiogenesis.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2731903|NCT01004822|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||hours||Standard Deviation|Mean
2731904|NCT01004822|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Due to premature termination of the study, only certain exposure-related noncompartmental PK parameters were calculated.|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study, CL data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.||||||
2731905|NCT01004822|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study Cmin data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.||||||
2731906|NCT01004822|Secondary|Maximum Observed Plasma Concentration (Cmax)|Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2731907|NCT01004822|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - ∞)u for unbound drug. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|"Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2731908|NCT01004822|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs and non-SAEs that occurred during the study.|Baseline up to 28 days after last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||participants|||Number
2731909|NCT01004822|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Week 4|Safety analysis set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2731910|NCT01004822|Primary|Recommended Phase 2 Dose (RP2D)|RP2D was the highest dose where 0 of 3 or less than (<2) out of 6 participants experience a DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study RP2D could not be assessed.||||||
2731947|NCT01004354|Secondary|Triglycerides at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
2731911|NCT01004822|Primary|Maximum Tolerated Dose (MTD)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study MTD could not be assessed.||||||
2731912|NCT01004770|Primary|Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image|Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase|Pre and post contrast administration|Per Study Protocol|||Hounsfield Units||Standard Deviation|Mean
2731913|NCT01004770|Primary|12-Lead Electrocardiogram (ECG) Values|12-Lead ECG values taken up to and including 24 hours|Baseline and up to and including 24 hours post contrast administration|Per Study Protocol|||QTcB (msec)||Standard Deviation|Mean
2731914|NCT01004770|Primary|Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values|Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.|Baseline and up to and including 8 hours post contrast administration|Per Study Protocol|||> 10 beats per minute (bpm)||Standard Deviation|Mean
2731915|NCT01004770|Primary|Vital Signs (Blood Pressure) Systolic and Diastolic Values|Systolic and Diastolic bolld pressure taken up to and including 8 hours|Baseline and up to and including 8 hours post contrast administation.|Per Study Protocol|||mm Hg||Standard Deviation|Mean
2731916|NCT01004770|Primary|Blood Urea Nitrogen and Creatinine Serum Values|Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.|Baseline and up to and including 72 hours post contrast administration|Per Study Protocol|||mg/dL||Standard Deviation|Mean
2731917|NCT01004705|Secondary|The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population|||mg/dL||Standard Deviation|Mean
2731918|NCT01004705|Primary|The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population|||mg/dL||Standard Deviation|Mean
2731919|NCT01004614|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||hour||Full Range|Median
2731920|NCT01004614|Secondary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||hour||Standard Deviation|Mean
2731921|NCT01004614|Secondary|Apparent Terminal Elimination Half-Life (T-half)|Terminal phase half-life calculated as ln(2) / kel|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||hour||Standard Deviation|Mean
2731922|NCT01004614|Secondary|Apparent Terminal Elimination Phase Rate Constant (Kel)|Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||L/h||Standard Deviation|Mean
2731923|NCT01004614|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)|"AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.~AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration."|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||ng*h/mL||Standard Deviation|Mean
2731924|NCT01004614|Primary|Maximum Observed Plasma Concentration (Cmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||ng/mL||Standard Deviation|Mean
2731925|NCT01004614|Primary|Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)|Area under the concentration-time curve from zero time until the last sampling time|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||ng*h/mL||Standard Deviation|Mean
2731926|NCT01004510|Primary|Rate of Control (Lack of Need for Palliative Intervention of Malignant Pleural Effusions) in Patients With Non Small Cell Lung Cancer Treated With Standard Regimens of Cytotoxic Chemotherapy With the Addition of Zometa||3 months|Too few patients enrolled to analyze data||||||
2731936|NCT01004406|Primary|Change in the Total Atheroma Volume of the Target Coronary Artery From Baseline to 12 Weeks Post-PCI as Assessed Via Intravascular Ultrasound With Virtual Histology (IVUS-VH)|The primary effectiveness outcome measure was the change in the total atheroma volume within a ≥ 20 mm long segment of the target coronary artery from baseline to 12 weeks post-PCI. The measurement was done via IVUS-VH at 2 time points (baseline during index PCI and 12-week follow-up).|baseline and 12-week follow-up|Reported results are based on Intent-to-Treat (ITT) approach.|||mm^3||Standard Deviation|Mean
2731927|NCT01004432|Secondary|Change in ESR-based DAS28 Score at Week 76 Relative to Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.|Week 52, 76|Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and ‘n’ = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).|||units on a scale||Standard Deviation|Mean
2731928|NCT01004432|Secondary|Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.|Week 76|Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).|||percentage of participants||95% Confidence Interval|Number
2731929|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.|Week 52|Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.|||percentage of participants||95% Confidence Interval|Number
2731930|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.|Week 52|Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period.|||percentage of participants||95% Confidence Interval|Number
2731931|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Within 2 weeks of initiating therapy|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2731932|NCT01004432|Primary|Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Week 14|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2731933|NCT01004406|Secondary|Major Adverse Cardiovascular Events|The number of patients who experienced major adverse cardiovascular endpoints (MACE) including death, myocardial infarction, coronary revascularization, and stroke during the follow-up periods.|6 months||||Participants|||Count of Participants
2731934|NCT01004406|Secondary|Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) Per Milliliter of Peripheral Blood Across Time|The cell culture assay and quantification of circulating EPC-CFU were performed for patients recruited at the Dallas VA center only. The assay were done at 4 time points (pre-PCI, post-PCI, 4-week follow-up, and 12-week follow-up).|pre-PCI, post-PCI, 4-week follow-up, and 12-week follow-up|Reported results are based on observed data from participants who had secondary outcome measured. This outcome was captured for Dallas site only.|||colonies/ml||Standard Deviation|Mean
2731952|NCT01004354|Secondary|Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment|"HOMA-IR:~It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5"|Baseline and 8 weeks||||HOMA-IR score||Standard Deviation|Mean
2731953|NCT01004354|Primary|Change in Weight||Baseline and 8 weeks||||kilograms||Standard Deviation|Mean
2731954|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
2731955|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
2731956|NCT01004263|Secondary|Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.|2 hours post dose|All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation|||percentage of participant's attacks||Standard Deviation|Mean
2731957|NCT01004263|Primary|Number of Participants With AEs Within 14 Days Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
2731958|NCT01004263|Primary|Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
2731959|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Percentage of Participants||95% Confidence Interval|Number
2731960|NCT01004250|Secondary|Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Percentage of Participants||95% Confidence Interval|Number
2731961|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)|Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Percentage of Participants||95% Confidence Interval|Number
2732000|NCT01004003|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set which included all patients who received at least one single dose of trial medication, including phase I patients from the dose escalation part that were not replaced for MTD determination.|||mg bid|||Number
2731962|NCT01004250|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.|From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)|32 participants were censored. All enrolled participants receiving at least one dose of study drug.|||Months||95% Confidence Interval|Median
2731963|NCT01004250|Primary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.|From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)|"30 participants were censored. Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Months||90% Confidence Interval|Median
2731964|NCT01004185|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.|Week 26|mITT Subjects who took at least one dose of study medication and did not have baseline stool examination positive for C. difficile, bacterial pathogens or ova/parasites.|||percentage of participants|||Number
2731965|NCT01004185|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.|Week 26|MITT subjects who took at least one dose of study medication and did not have baseline stool exam positive for C. difficile, bacterial pathogens or ova/parasites.|||percentage of participants|||Number
2731966|NCT01004172|Secondary|Overall Survival|Participants were assessed every 6 months post-treatment. Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Maximum survival follow-up for the study cohort was 66 months.|The analysis dataset is comprised of enrolled patients.|||months||95% Confidence Interval|Median
2731967|NCT01004172|Secondary|Site of First Progression|"Site of first progression is classified as follows:~CNS Disease~>/=40% increase in the volumetric sum of all measurable lesions as compared to the smallest volume on treatment~Progression of non-measurable lesions~New lesions (>/=6 mm) Non-CNS Disease~Per RECIST 1.0 criteria: PD is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.~Symptomatic~Increasing steroid requirement~Global deterioration of health status requiring discontinuation of treatment~New/progression tumor-related neurologic signs and symptoms (NSS) except for transient worsening lasting </=14 days"|Disease was evaluated radiologically at baseline, cycle 2, cycle 4 and thereafter on treatment every 2 cycles (CNS disease) and every 4 cycles (non-disease). Maximum progression follow-up for this study cohort was 18.6 months.|The analysis dataset is comprised of all enrolled participants.|||participants|||Number
2731968|NCT01004172|Secondary|CNS Best Response|"CNS best response was defined based on standard criteria. Adding to CR and PR (defined in the primary outcome measure):~CNS stable disease (SD) is achieving all the following:~< 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline~No progression on non-measurable lesions~No new CNS lesions (defined as any new lesion >/= 6 mm in LD)~Stable or decreasing steroid dose~No new/progressive tumor-related neurologic signs or symptoms~No progression of extra-CNS disease as assessed by RECIST~CNS Progressive Disease (PD) was experiencing any of the following:~->/- 40% increase in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline~Progression on non-measurable lesions~New CNS lesions (defined as any new lesion >/= 6 mm in LD)~Increasing steroid dose~New/progressive tumor-related neurologic signs or symptoms~Progression of extra-CNS disease as assessed by RECIST"|Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.|The analysis dataset is comprised of assessable participants. Per protocol, assessable is defined as those who have at least one lesion on baseline MRI with longest with longest diameter >10 mm on T1-weighted, gadolinium-enhanced. All enrolled participants were assessable.|||Participants|||Count of Participants
2732019|NCT01003886|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.|||Participants|||Number
2732020|NCT01003639|Secondary|Visual Acuity (No. of Correct Letters)||Baseline||||correct letters||Standard Deviation|Mean
2731969|NCT01004172|Secondary|Progression-Free Survival|"Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of disease progression (PD), second cancer, or death, whichever occurs first. PD if any of the following occur:~CNS Disease~>/=40% increase in the volumetric sum of all measurable lesions as compared to the smallest volume on treatment~Progression of non-measurable lesions~New lesions (>/=6 mm)~Non-CNS Disease~• RECIST 1.0 criteria: at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded on treatment or the appearance of >/=1 new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.~Symptomatic~Increasing steroid requirement~Global deterioration of health status requiring discontinuation of treatment~New/progression tumor-related neurologic signs and symptoms except for transient worsening lasting </=14 days"|Disease was evaluated radiologically at baseline, cycle 2, cycle 4 and thereafter on treatment every 2 cycles (CNS disease) and every 4 cycles (non-disease). Maximum PFS follow-up for this study cohort was 18.6 months.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2731970|NCT01004172|Primary|Central Nervous System (CNS) Objective Response Rate|"CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows:~CNS complete response (CR) is achieved if all of the following are satisfied:~Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases~No new CNS lesions (defined as any new lesion >= 6 mm in LD)~Stable or decreasing steroid dose~No new/progressive tumor-related neurologic signs or symptoms~No progression of extra-CNS disease as assessed by RECIST~CNS partial response (PR) is achieved if all of the following are satisfied:~->/= 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline~No progression on non-measurable lesions~No new CNS lesions (defined as any new lesion >/= 6 mm in LD)~Stable or decreasing steroid dose~No new/progressive tumor-related neurologic signs or symptoms~No progression of extra-CNS disease as assessed by RECIST"|Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.|The analysis dataset is comprised of assessable participants. Per protocol, assessable is defined as those who have at least one lesion on baseline MRI with longest with longest diameter >10 mm on T1-weighted, gadolinium-enhanced. All enrolled participants were assessable.|||percentage of participants||95% Confidence Interval|Number
2731971|NCT01004159|Secondary|Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population||18 months|All treated and eligible patients|||percentage of particitpants||95% Confidence Interval|Number
2731972|NCT01004159|Primary|12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer||12 week|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2731973|NCT01004146|Secondary|Respiratory Rate||one week prior to surgery to post operative day 1|||||||
2731974|NCT01004146|Secondary|Heart Rate||one week prior to surgery to post operative day 1|||||||
2731975|NCT01004146|Secondary|Oxygen Saturation||one week prior to surgery up to one day after|||||||
2731976|NCT01004146|Secondary|Level of Compliance||3 days to 2 weeks after clinic visit on the day of surgery|||||||
2731977|NCT01004146|Primary|Post Operative Incentive Spirometry Volume|After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.|1 week before surgery to the day after||||cc||Standard Deviation|Mean
2731978|NCT01004107|Secondary|Normal Work During Prior Week Evaluation|"Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never:~How often were you unable to do your work because of problems with your hand(s) / wrist(s)?~How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?~How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?~How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?~How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.|||units on a scale||Standard Deviation|Mean
2731979|NCT01004107|Secondary|Difficulty Performing Activities During Prior Week, Both Hands|"Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:~Open a jar~Button a shirt / blouse~Eat with a knife and fork~Carry a grocery bag~Wash dishes~Wash your hair~Tie shoelaces / knots"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.|||units on a scale||Standard Deviation|Mean
2731980|NCT01004107|Secondary|Difficulty Performing Activities During Prior Week|"Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:~Turn a knob~Pick up a coin~Hold a glass of water~Turn a key in a lock~Hold a frying pan"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set; see previously reported population description. 1 subject did not complete baseline, right hand questionnaire. 2 subjects did not complete baseline, left hand questionnaire.1 subject did not complete 6-month questionnaire for either hand.|||units on a scale||Standard Deviation|Mean
2731981|NCT01004107|Secondary|Mean Hand Function Rating During Prior Week|"Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor:~Overall, how well did you hand work?~How well did your fingers move?~How well did your wrist move?~How was the strength in your hand?~How was the sensation (feeling) in your hand?"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 1 subject did not complete questionnaire at 6 months.|||units on a scale||Standard Deviation|Mean
2731982|NCT01004107|Secondary|Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments|Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months|3, 6, 9, and 12 months from baseline|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of participants|||Number
2731983|NCT01004107|Secondary|Patient Satisfaction Evaluation|Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months|3, 6, 9, and 12 months from baseline|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of participants|||Number
2731984|NCT01004107|Secondary|Physician Satisfaction Evaluation|Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject|3, 6, 9, and 12 months from baseline|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of physicians|||Number
2731985|NCT01004107|Secondary|"Global Aesthetic Improvement Scale (GAIS) Ratings of at Least Improved Over Study"|Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators|3, 6, 9, and 12 months from baseline|GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.|||percentage of participants|||Number
2731986|NCT01004107|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand|To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.|3, 6, 9, and 12 months from baseline|GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.|||percentage of hands|Hands||Number
2731987|NCT01004107|Secondary|"Global Aesthetic Improvement Scale (GAIS) Ratings of at Least Improved Among the Original Treatment Group Only"|Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators|3 months from baseline|3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once|||percentage of participants|||Number
2731988|NCT01004107|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only|To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.|3 months from baseline|3-month GAIS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of hands|Hands||Number
2731989|NCT01004107|Secondary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3, 6, 9, and 12 months from baseline|3-,6-, 9-, and 12-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. After 3 months, the untreated controls were treated with Radiesse and were followed as per the original treatment group.|||percentage of participants|||Number
2732018|NCT01003886|Secondary|Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12|The IPSS total score is obtained by combining the scores of the responses to 1 through 7 component questions all of which were on a 6 point likert scale. Each question is scored from 0-5 for an IPSS range of 0-35 points where 0 = best possible score to 35 = worst possible score.|Baseline, Week 4 and Week 12|Full analysis set (FAS) population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the last observation carried forward (LOCF). The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Units on a scale||Standard Deviation|Mean
2739116|NCT00957359|Primary|HADS Anxiety|0-21 (higher score more anxiety)|1 day post drug administration 2||||score on a scale||Standard Error|Mean
2731990|NCT01004107|Secondary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3, 6, 9, and 12 months from baseline|BHVSS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.|||percentage of hands|Hands||Number
2731991|NCT01004107|Secondary|Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3, 6, 9, and 12 months from baseline|BHVSS: safety analysis set or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||units on a scale|Hands|Standard Deviation|Mean
2731992|NCT01004107|Primary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3 months from baseline||||percentage of participants|||Number
2731993|NCT01004107|Primary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3 months from baseline|3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once|||percentage of hands|Hands||Number
2731994|NCT01004107|Primary|Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3 months from baseline|3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled & withdrew prior to treatment.|||units on a scale|Hands|Standard Deviation|Mean
2731995|NCT01004003|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants|||months||Inter-Quartile Range|Median
2731996|NCT01004003|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants|||months||Inter-Quartile Range|Median
2731997|NCT01004003|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.~95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, phase II participants only|||percentage of participants||95% Confidence Interval|Number
2731998|NCT01004003|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).|||participants|||Number
2731999|NCT01004003|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants.|||months||Inter-Quartile Range|Median
2732001|NCT01003990|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.|Date of First Dose to 30 days post the last dose; approximately 405 weeks)|All Treated Participants|||Participants|||Count of Participants
2732002|NCT01003938|Secondary|Toxicity Profile|"Number of participants (patients) who experienced AEs.~Dry skin, dry eye, acne, erythema, rash, pruritus, and diarrhea were related erlotinib; dehydration, anemia, leukopenia, nausea, vomiting, platelets, and fatigue were realted to topotcan."|the whole treatment phase and 30 days post-treatment||||participants|||Number
2732003|NCT01003938|Secondary|Overall Survival|estimated total time from the start of the trial|4 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
2732004|NCT01003938|Secondary|Time to Progression|Time to progression is defined as the time from first study drug administration until the first day radiological and /or symptomatic disease progression is documented, or until death in the absence of progression.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
2732005|NCT01003938|Secondary|CA125 Stable Disease Duration|Stable disease (SD) duration is measured from the tile of start of therapy until the criteria for progression are met. SD: CA125 decreases <50% or increases <100%. Disease progression: CA125 doubles the value of baseline, or more, over time.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
2732006|NCT01003938|Secondary|CA125 Response Duration|Response duration is measured from the time measurement criteria for CA125 CR/PR at the first met until the first date that recurrent or progressive disease is objectively documented.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
2732007|NCT01003938|Primary|CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib|Response was assessed after every treatment cycle. Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR). CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by >50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.|Up to 3 years||||participants|||Number
2732008|NCT01003899|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Baseline till progression or death|||||||
2732009|NCT01003899|Secondary|Time to OR|The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.|Baseline till progression or death|||||||
2732010|NCT01003899|Secondary|Duration of Disease Control (DC)|Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).|Baseline till progression or death|FAS - Full Analysis Set|||weeks||Full Range|Median
2732011|NCT01003899|Secondary|Progression Free Survival (PFS) Time|PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death|Baseline till end of study or death|FAS - Full Analysis Set|||Weeks||95% Confidence Interval|Median
2732012|NCT01003899|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.|Baseline till progression or death|FAS - Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2732013|NCT01003899|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).|Baseline till progression or death|FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.|||Percentage of participants||95% Confidence Interval|Number
2732014|NCT01003886|Secondary|Percentage of Participants With Postural Hypotension|Postural or orthostatic hypotension is a medical condition where blood pressure falls rapidly after the body changes position most commonly occurring after standing up after sitting for long periods of time.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.|||Percentage of participants|||Number
2732015|NCT01003886|Secondary|Change From Baseline in Diastolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||mmHg||Standard Deviation|Mean
2732016|NCT01003886|Secondary|Change From Baseline in Systolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||mmHg||Standard Deviation|Mean
2732017|NCT01003886|Secondary|Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12|The IPSS QoL Score is obtained by assessment of a single QoL question on a 7-point likert scale which was scored on a scale of 0-6 where 0 = best possible score to 6 = worst possible score.|Baseline, Week 4 and Week 12|FAS population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the LOCF. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Units on a scale||Standard Deviation|Mean
2732022|NCT01003639|Secondary|Mean Change of Papilledema Grade on Fundus Photography|Mean change at month 6 as compared to baseline. Frisén papilledema grade is an ordinal scale that uses ocular fundus features to rate the severity of papilledema; grade 0 indicates no features of papilledema and grade 5 indicates severe papilledema.|Baseline and 6 Months|Sixty-nine of the 86 participants (80%) in the acetazolamide group completed follow-up compared with 57 of the 79 participants (72%) in the placebo group.|||units on a scale||Standard Error|Mean
2732023|NCT01003639|Primary|Mean Change in Perimetric Mean Deviation|Treatment Effects on the Primary Outcome Variable, Mean change From Baseline to Month 6 in Perimetric Mean Deviation (PMD) in the Study Eye. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to −32 dB; larger negative values indicate greater vision loss.|base line and 6 months|Sixty-nine of the 86 participants (80%) in the acetazolamide group completed follow-up compared with 57 of the 79 participants (72%) in the placebo group.|||dB||Standard Error|Mean
2732024|NCT01003418|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Results about SAEs were based on individual listings.|During the entire study period (From Month 0 up to Month 11)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2732025|NCT01003418|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. Results about unsolicited AEs for this endpoint were based on individual listings.|During the 28-day (Days 0-27) follow-up period after each study vaccine administration|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2732026|NCT01003418|Secondary|Number of Subjects With Any Solicited Local or General Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.|During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)||||Participants|||Count of Participants
2732027|NCT01003418|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the 2-weeks post-Dose 1 period (Days 0-13)||||Participants|||Count of Participants
2732028|NCT01003418|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.|During the 2-weeks post-Dose 1 period (Days 0-13)||||Participants|||Count of Participants
2732029|NCT01003418|Primary|Number of Subjects With Any Solicited Local or General Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.|During the 7-days post-Dose 1 period (Days 0-6)||||Participants|||Count of Participants
2732030|NCT01003301|Primary|The the Size of the 8 Late-phase Skin Response|Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.|Baseline, 2-6 wks||||percentage decline from NAC-1||Standard Deviation|Mean
2732031|NCT01003288|Secondary|Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay|Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response|7, 14, 21 days post vaccination and long term follow up for 5 years|Only HCW 251 were assessed for HI antibodies at 21 days post vaccination|||participants|||Number
2732032|NCT01003288|Primary|Number of Participants With Local and Systemic Adverse Events|Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.|21 days after vaccination|solicited adverse event forms were collected from the volunteers|||participants|||Number
2732033|NCT01003275|Primary|Glucose Area Under the Curve (AUC)|Glucose AUC during a 2-hour oral glucose tolerance test|8 weeks||||mg*min/dL||Geometric Coefficient of Variation|Geometric Mean
2732034|NCT01003249|Secondary|Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day|The number of voiding per day before and after treatment.|Baseline and 4 weeks||||number of voids||Standard Deviation|Mean
2732035|NCT01003249|Secondary|Number (and Percentage) of Participants With External Anal Sphincter Muscle Dysfunction Via Patient Symptoms.|The percent of patient in each group who had defecation problem|Baseline and 4 weeks||||Participants|||Count of Participants
2732036|NCT01003249|Primary|Average Scores on Dysfunctional Voiding as Measured With Quality of Life (QOL) Questionnaire|This was measured using the Urogenital Distress Inventory (UDI-6). The UDI-6 is a symptom inventory specific to lower urinary tract dysfunction and genital prolapse. There are 6 items scored. The score range is from 0-100 Lower scores denotes better outcomes.|Baseline and 4 weeks||||scores on a scale||Standard Deviation|Mean
2732082|NCT01002742|Secondary|Cumulative Steroid Dose|The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week's dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.|Days 28 and 56||||mg/kg|||Number
2732037|NCT01003249|Primary|Average Scores on International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|Diagnosis of dysfunctional bladder is based on symptoms demonstrating no relaxation or over stimulation of external urinary sphincter during voiding. Symptoms will be scored by International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). The ICIQ-LUTSqol is a patient-completed questionnaire for evaluating quality of life (QoL) in urinary incontinent patients There are 20 items and the score range is 10-200. Higher scores denotes better outcomes.|Baseline and 4 weeks||||scores on a scale||Standard Deviation|Mean
2732038|NCT01003249|Primary|Number of Participants Exhibiting Abnormal EMG Activity During Voiding|EMG with patch electrodes was completed at the end of this four week period. The number of participants with EMG activity during voiding was collected. EMG activity during the voiding is considered abnormal and is a criteria for voiding dysfunction.Lower numbers denotes better outcomes.|Baseline and 4 weeks||||Participants|||Count of Participants
2732039|NCT01003249|Primary|Urine Flow Rate, as Measured With Uroflometry|Uroflometry with patch electrodes will also be completed at the end of this four week period. Higher flow rate denotes better outcome.|Baseline and 4 weeks||||ml/s||Standard Deviation|Mean
2732040|NCT01003210|Secondary|Side Effects From Study Remedy|"Any other symptoms reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone."|15 days|The number of participants analyzed includes only those whose parents returned logbooks.|||participants|||Number
2732041|NCT01003210|Primary|Administration of Antibiotics|Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.|15 days||||participants|||Number
2732042|NCT01003210|Primary|Severity of Symptoms of Otitis Media|Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment|15 days||||units on a scale||Standard Deviation|Mean
2732043|NCT01003184|Secondary|Hypoglycemia Rate Per Year|All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.|Baseline, Week 26|Full analysis set (as randomized).|||events per subject-year||95% Confidence Interval|Number
2732044|NCT01003184|Secondary|Change in Triglycerides From Baseline to Endpoint (Week 26).|Change in triglycerides from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.|||mmol/L||Standard Error|Least Squares Mean
2732045|NCT01003184|Secondary|Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).|Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.|||mmol/L||Standard Error|Least Squares Mean
2732046|NCT01003184|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26).|Change in total cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).~The last observation carried forward (LOCF) of post baseline values was used for this analysis."|||mmol/L||Standard Error|Least Squares Mean
2732047|NCT01003184|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in diastolic blood pressure from baseline to week 26.|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||mmHg||Standard Error|Least Squares Mean
2732048|NCT01003184|Secondary|Changes in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline to Week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||mmHg||Standard Error|Least Squares Mean
2732049|NCT01003184|Secondary|Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).|Change in fasting serum glucose from baseline to endpoint (Week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).~The last observation carried forward (LOCF) of post baseline values was used for this analysis."|||mmol/L||Standard Error|Least Squares Mean
2732050|NCT01003184|Secondary|Percentage of Patients Achieving ≤6.5% at Endpoint|Percentage of patients achieving HbA1c ≤6.5% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.|||Percentage||95% Confidence Interval|Number
2732051|NCT01003184|Secondary|Percentage of Patients Achieving ≤7.0% at Endpoint|Percentage of patients achieving ≤7.0% at endpoint.|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.|||Percentage||95% Confidence Interval|Number
2732052|NCT01003184|Secondary|Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint|Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.|||Percentage||95% Confidence Interval|Number
2732053|NCT01003184|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||kilograms||Standard Error|Least Squares Mean
2732054|NCT01003184|Secondary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
2732083|NCT01002742|Secondary|Incidence of Discontinuation of Immune Suppression Without Flare||Day 56, Day 180 and Day 360 post-treatment|No data collected||||||
2739117|NCT00957359|Primary|HADS Depression|Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)|6 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2732055|NCT01003184|Secondary|Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)|Baseline, Week 26|The analysis was done for the FAS population (as randomised). For secondary analyses including both final HbA1c concentration and change in weight the last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value.|||Percentage||95% Confidence Interval|Number
2732056|NCT01003184|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.|Baseline, Week 26|The full analysis set (FAS) includes all data from all randomised patients receiving at least one dose of the study drug according to the treatment the patients were assigned.|||Percentage||95% Confidence Interval|Number
2732057|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36||||microns||Standard Error|Mean
2732058|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6||||microns||Standard Error|Mean
2732059|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36||||Letters||Standard Error|Mean
2732060|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6||||Letters||Standard Error|Mean
2732061|NCT01003106|Primary|Incidence and Severity of Ocular and Non-ocular Adverse Events.||36 months||||participants|||Number
2732062|NCT01003080|Primary|Drain Output.|This is a measure of the average drain output collected in the first 24 hours following surgery.|First 24 hours following surgery.||||mL||Standard Deviation|Mean
2732063|NCT01003067|Secondary|Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.|Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.|5 Years||2020-06-30|06/2020||||
2732064|NCT01003067|Primary|Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy|Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.|2 years||||participants|||Number
2732065|NCT01002989|Primary|Mean Watch BP Office Ankle-Brachial Index||once (cross-sectional)||||ratio||Standard Deviation|Mean
2732066|NCT01002989|Primary|Mean Doppler Ankle-Brachial Index||once (cross-sectional)||||ratio||Standard Deviation|Mean
2732067|NCT01002989|Secondary|Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis|This outcome measure represents what percentage of the patients diagnosed with PAD using Doppler ABI method (reference method) were diagnosed with PAD using WatchBP Office ABI method. It also represents in what percentage of the patients in whom PAD was excluded with Doppler ABI method (reference method), PAD was excluded using WatchBP Office ABI method as well.|Once (cross-sectional)||||Percentage of participants|||Number
2732068|NCT01002989|Primary|Watch BP Office Minus Doppler Ankle-Brachial Index Difference|The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors.|once (cross-sectional)|Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic were invited to participate in the study. Subjects with atrial fibrillation or incompressible ankle arteries (ABI ≥1.4) were excluded.|||ratio||Standard Deviation|Mean
2732069|NCT01002755|Secondary|Progression Free Survival|The time from the start of therapy to death, disease progression, or the initiation of the next therapy. Disease progression is the loss of response or transformation to a more aggressive histology.|Up to 8 years||||months||95% Confidence Interval|Median
2732070|NCT01002755|Secondary|Number of Participants With Tolerance of the Medication Combination|Incidence of grade 3 and 4 non-hematological toxicity in more than 50 percent of the participants. Will be monitored based on the Bayesian model (beta-binomial).|Up to 8 years||||participants|||Number
2732071|NCT01002755|Primary|Overall Response Rate|A Simon's two-stage minmax design will be used. Includes complete remission (CR) and partial remission (PR). Complete Response Requires the absence of disease signs and symptoms, and normalization of Peripheral blood and bone marrow. Partial Response it at lease a 50% reduction in disease signs and symptoms and normalization of peripheral blood.|Up to 8 years|Two participants were not evaluable for response.|||Participants|||Count of Participants
2732072|NCT01002742|Secondary|Change in Patient Reported Outcomes From Enrollment to Day 56||Day 56|No data collected||||||
2732073|NCT01002742|Secondary|Treatment Related Mortality (TRM)||Year 1||||percentage of participants||95% Confidence Interval|Number
2732074|NCT01002742|Secondary|Disease-Free Survival (DFS) Post-Randomization|DFS includes death or progression/relapse of malignancy|Year 1||||percentage of participants||95% Confidence Interval|Number
2732075|NCT01002742|Secondary|Cumulative Incidence of a Severe/Life-threatening/Fatal Infections||Year 1||||percentage of participants||95% Confidence Interval|Number
2732076|NCT01002742|Secondary|Incidence of Cytomegalovirus (CMV) Reactivation||Year 1||||percentage of participants|||Number
2732077|NCT01002742|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||12 months||||participants|||Number
2732078|NCT01002742|Secondary|Incidence of Systemic Infections|Number of participants that experienced at least one infection.|6 Months||||participants|||Number
2732079|NCT01002742|Secondary|Incidence of Chronic GVHD||12 months post-randomization||||percentage of participants||95% Confidence Interval|Number
2732084|NCT01002742|Secondary|Incidence of GVHD Flares Requiring Increased Therapy|Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.|Day 90||||participants|||Number
2732085|NCT01002742|Secondary|Percentage of Surviving Participants With Complete Response (CR)|CR is defined as a score of 0 for the GVHD grading in all evaluable organs.|Days 14, 28, and 56||||percentage of participants|||Number
2732086|NCT01002742|Primary|GVHD-free Survival|Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.|Day 56||||participants|||Number
2732087|NCT01002573|Secondary|Number of Afebrile and Febrile Subject at 4 Hours Post-Dose|Number of Afebrile and Febrile Subject at 4 Hours Following Treatment|4 Hours Post-Dose|Some participants data was not included in the analysis due to having too few/insufficient data|||participants|||Number
2732088|NCT01002573|Secondary|Time to Afebrility (in Hours)|Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.|4 Hour post treatment||||Hours||Standard Deviation|Mean
2732089|NCT01002573|Secondary|Change From Baseline in Temperature After the First Four Hours of Treatment|Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)|0 to 4 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data|||degree Celsius*Time||Standard Deviation|Mean
2732090|NCT01002573|Secondary|Change in Temperature|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.|4 hours following treatment|Some participants data was not included in the analysis due to having too few/insufficient data|||Celsius||Standard Deviation|Mean
2732091|NCT01002573|Secondary|Change From Baseline in Temperature After the First 60 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.|60 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data|||Celsius||Standard Deviation|Mean
2732092|NCT01002573|Secondary|Change From Baseline in Temperature After the First 30 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.|30 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data|||Celsius||Standard Deviation|Mean
2732093|NCT01002573|Primary|Fever Reduction|Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)|0 to 2 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data|||degree Celsius*Time||Standard Deviation|Mean
2732094|NCT01002547|Secondary|LDL-cholesterol|Change from baseline in plasma LDL-cholesterol after 18 months of therapy|Month 18|All patients completing 18 months of therapy|||mg/dl||Standard Deviation|Mean
2732095|NCT01002547|Secondary|HDL-cholesterol|Change from baseline in plasma HDL-cholesterol after 18 months of therapy|Month 18|All patients completing 18 months of follow-up|||mg/dl||Standard Deviation|Mean
2732096|NCT01002547|Secondary|Triglycerides|Change from baseline in plasma triglycerides after 18 months of therapy|Month 18|All patients completing 18 months of follow-up|||mg/dl||Inter-Quartile Range|Median
2732097|NCT01002547|Secondary|Total Cholesterol|Change from baseline in plasma total cholesterol after 18 months of therapy|Month 18||||mg/dl||Standard Deviation|Mean
2732098|NCT01002547|Secondary|Matsuda Index|This is a method for assessing insulin resistance (IR) based on measurements of glucose and insulin during the oral glucose tolerance test. The formula used is = (10000/(SQRT(fasting plasma glucose * fasting plasma insulin * ((fasting plasma glucose * 15 + glucose at minute 30 * 30 + glucose at minute 60 * 30 + glucose at minute 90 * 30 + glucose at minute 120 * 15)/120)*((fasting plasma insulin * 15 + insulin at minute 30 * 30 + insulin at minute 60 * 30 + insulin at minute 90 * 30 + insulin at minute 120 * 15)/120))), with a lower value representing worse insulin resistance.|Month 18|Patients completing 18 months of follow-up, not on insulin therapy|||units on a scale||Standard Error|Mean
2732099|NCT01002547|Secondary|Fasting Plasma Insulin|Change from baseline after 18 months of therapy|Month 18|Patients completing 18 months of follow-up, not on insulin therapy|||uU/ml||Standard Deviation|Mean
2732100|NCT01002547|Secondary|Fasting Plasma Glucose|Change from baseline after 18 months of therapy|Month 18|Patients completing 18 months of therapy|||mg/dl||Standard Deviation|Mean
2732101|NCT01002547|Secondary|Plasma ALT|Change from baseline in plasma ALT after 18 months of therapy|Month 18|Patients completing 18 months of follow-up|||U/L||Standard Deviation|Mean
2732102|NCT01002547|Secondary|Plasma AST|Change from baseline in plasma AST after 18 months of therapy|Month 18|Patients completing 18 months of follow-up|||U/L||Standard Deviation|Mean
2732103|NCT01002547|Secondary|Total Body Fat by DEXA|Change from baseline in total body fat by DEX after 18 months of therapy|Month 18|Patients completing 18 months of follow-up|||percentage||Standard Deviation|Mean
2732104|NCT01002547|Secondary|Body Mass Index|Weight (in kg) / (Height [in m] x Height [in m])|Month 18|Patients completing 18 months of follow-up.|||kg/m2||Standard Deviation|Mean
2732105|NCT01002547|Secondary|Weight|Change from baseline in weight|Month 18|Patients completing 18 months of follow-up|||kg||Standard Deviation|Mean
2732106|NCT01002547|Secondary|Liver Fat by Magnetic Resonance Imaging and Spectroscopy (MRS).|Change from baseline in intrahepatic triglyceride content after 18 months of therapy|Month 18|Patients completing 18 months of therapy|||percentage||Standard Deviation|Mean
2732107|NCT01002547|Secondary|Individual Histological Scores|"Number of patients with improvement of at least 1 grade in each of the histological parameters.~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x.~Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning.~Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis."|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
2739118|NCT00957359|Primary|HADS Depression|Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)|1 day post drug administration 1||||score on a scale||Standard Error|Mean
2732108|NCT01002547|Secondary|Mean Individual Histological Scores|"Mean change in individual scores compared to baseline. Steatosis range 0-3, where: 0 = <5% fat; 1 = 5-33% fat; 2 = >33-66% fat; 3 = >66% fat.~Lobular Inflammation, range 0-3, where: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x.~Hepatocyte Ballooning, range 0-2, where: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning.~Fibrosis stage, range 0-4, where: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis."|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||units on a scale||Standard Deviation|Mean
2732109|NCT01002547|Secondary|Number of Participants With Resolution of NASH Without Worsening of Fibrosis|Resolution of NASH was defined as absence of NASH after 18 months of therapy in patients with definite NASH (presence of zone 3 accentuation of macrovesicular steatosis of any grade, hepatocellular ballooning of any degree, and lobular inflammatory infiltrates of any amount) at baseline.|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
2732110|NCT01002547|Primary|Liver Histology (Kleiner's et al Criteria, Hepatology 2005)|"Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 .~The scoring system is based on the following grading:~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis."|18 months|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
2732111|NCT01002482|Secondary|Incidence of Nosocomial Bacteriemia||Date of discharge from the ICU|||||||
2732112|NCT01002482|Secondary|Intensive Care Unit Length of Stay||Date of discharge from the ICU||||days||Inter-Quartile Range|Median
2732113|NCT01002482|Secondary|Hospital Length of Stay||Date of discharge from the hospital||||days||Inter-Quartile Range|Median
2732114|NCT01002482|Secondary|Severe Hypoglycemia|Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs|Date of discharge from the ICU||||participants|||Number
2732115|NCT01002482|Secondary|Time Spent in Blood Glucose Target||Day of discharge from the ICU|||||||
2732116|NCT01002482|Secondary|Intensive Care Unit Free Days|Intensive care unit free days was 28-day-ICU-free-days i.e. was calculated by subtracting the actual ICU duration in days from 28 with patients who died at day 28 or before being assigned 0 free-days and those who had a stay in ICU of 28 days or more being also assigned 0 free-days|28 days||||days||Inter-Quartile Range|Median
2732117|NCT01002482|Secondary|All-cause In-hospital Mortality||Day of discharge from the hospital||||participants|||Number
2732118|NCT01002482|Secondary|All-cause Intensive Care Unit Mortality||Date of discharge from the ICU||||participants|||Number
2732119|NCT01002482|Secondary|All-cause 28-day Mortality||Day 28||||participants|||Number
2732120|NCT01002482|Primary|All-cause 90-day Mortality||Day 90||||participants|||Number
2732121|NCT01002456|Secondary|Progress Toward Adherence to Guideline Prescription|either change to a guideline agent or dose increase of a guideline agent|6 months||||patients|||Number
2732122|NCT01002456|Primary|Rate of Adherence to Guideline Prescription|full adherence to guideline medication and dose|6 months||||patients|||Number
2732123|NCT01002339|Secondary|Percentage of Patients Using Acetylsalicylic Acid (ASA)||1 year|Analysis population description: participants living with a functioning graft at study end.|||percentage of participants||95% Confidence Interval|Number
2732124|NCT01002339|Secondary|Changes of Carotid Intima-media Thickness Over Time|absolute difference between carotid intima-media thickness at study end versus baseline.|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mm||95% Confidence Interval|Mean
2732125|NCT01002339|Secondary|Percentage of Patients Using Statins||1 year|Participants analyzed: participants living with a functioning graft at study end.|||percentage of participants||95% Confidence Interval|Number
2732126|NCT01002339|Secondary|Lipidic Profile (LDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
2732127|NCT01002339|Secondary|Lipidic Profile (HDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
2732128|NCT01002339|Secondary|Lipidic Profile (Cholesterol)|Lipidic Profile (total cholesterol)|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
2732129|NCT01002339|Secondary|Lipidic Profile (Triglycerides)||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
2732130|NCT01002339|Secondary|Number of Antihypertensive Drugs Patients Reported Taking.||1 year|Participants analyzed: participants living with a functioning graft at study end.|||number of antihypertensive drugs||Inter-Quartile Range|Median
2732131|NCT01002339|Secondary|Blood Pressure|Diastolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mmHg||Standard Deviation|Mean
2732132|NCT01002339|Secondary|Blood Pressure|Systolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mmHg||Standard Deviation|Mean
2732133|NCT01002339|Secondary|Proteinuria||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/day||95% Confidence Interval|Mean
2732134|NCT01002339|Secondary|Renal Function|Estimated Glomerular Filtration Rate (ml/min/1.73 m^2)|1 year|Participants analyzed: Participants living with a functioning graft at study end.|||ml/min/1.73 m^2||95% Confidence Interval|Mean
2732135|NCT01002339|Secondary|Rejection|Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.|1 year||||percentage of participants||95% Confidence Interval|Number
2732136|NCT01002339|Primary|Primary Outcome Measure (Glucose Intolerance)|Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.|1 year|Participants included are those that did not develop NODAT based on not reporting the use of anti-diabetic drugs plus a fasting plasma glucose <126 mg/dl .|||percentage of participants||95% Confidence Interval|Number
2732137|NCT01002339|Primary|Patients Treated With Insulin or Oral Antidiabetic Drugs||1 year|Participant analyzed: participants living with a functioning graft at study end.|||percentage of participants||95% Confidence Interval|Number
2732138|NCT01002339|Primary|"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"|American Diabetes Association criteria (ADA) including an oral glucose tolerance test.|1 year|Participants analyzed: participants living with a functioning graft at study end|||percentage of participants||95% Confidence Interval|Number
2732139|NCT01002287|Secondary|Mobilization Time|The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.|average 10-12 weeks post surgery|All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.|||minutes||Standard Deviation|Mean
2732140|NCT01002287|Secondary|Adhesion Involvement Along the Midline Incision (Percentage)|The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.|average 10-12 weeks post surgery|These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) * 100.|||percentage of midline incision||Standard Deviation|Mean
2732141|NCT01002287|Secondary|Severity of Adhesions|"Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are 1, 2, and 3. Subjects without adhesions were assigned a severity rating of 0."|Average 10-12 weeks post surgery|All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.|||units on a scale||Standard Deviation|Mean
2732142|NCT01002287|Primary|The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.||10-12 Weeks post Initial Surgery for J-Pouch|All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.|||percentage of subjects with adhesions|||Number
2732143|NCT01002118|Secondary|Medication Adherence|percent of pills taken each month calculated as number of pills taken/number of pills dispensed|4 months||||percentage of pills|||Number
2732144|NCT01002118|Secondary|Assess the Effectiveness of Omega-3 Fatty Acid Compared to Placebo on Electrocardiographic Parameters.|percent of subjects with significant arrhythmia present on Holter electrocardiography|4 months||||percentage of Holter montiors obtained|||Number
2732145|NCT01002118|Primary|Determine Recruitment Rates|Determine recruitment by number eligible/number enrolled|4 months||||Participants|||Count of Participants
2732146|NCT01002105|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing overall life satisfaction was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
2732147|NCT01002105|Secondary|Multidimensional Scale of Perceived Social Support|The MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales - family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.|Baseline, 52 weeks||||units on a scale||Standard Deviation|Mean
2732148|NCT01002105|Secondary|General Self-Efficacy Scale|"The GSES measures one's belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. Usually I am able to control a situation or In unexpected situations, I always know how I must behave myself). Responses are rated on a 4- point Likert-scale ranging from absolutely not true (weighted as 1) to absolutely true (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
2732149|NCT01002105|Secondary|General Health Questionnaire|The General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
2732212|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Liters||Standard Error|Least Squares Mean
2732150|NCT01002105|Secondary|Obsessive-Compulsive Drinking Scale Scores|Used to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
2732151|NCT01002105|Primary|Percent Abstinent Days|Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.|one year||||percentage of abstinent days|||Number
2732152|NCT01001988|Primary|Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV|Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.|Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2732153|NCT01001988|Primary|Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV|Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination|Seroprotection was analyzed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2732154|NCT01001975|Primary|Determination of Ultraviolet A Protection Factor (PFA)|Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).|2 to 4 hours post-exposure|Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA|||Score on a scale||Standard Deviation|Mean
2732155|NCT01001975|Primary|Determination of Sunscreen Protection Factor (SPF)|Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).|16 to 24 hours post-exposure|Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF|||Score on a scale||Standard Deviation|Mean
2732156|NCT01001832|Secondary|Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732157|NCT01001832|Primary|Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.|||units on a scale||95% Confidence Interval|Mean
2732158|NCT01001832|Primary|Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period|The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period.|Day 533|N=number of participants treated with at least 1 dose of study drug and with HAQ data available. n=number of participants with HAQ response. n/N = 41/52 and 31/51 in SC and IV arms, respectively. Treatment groups represent treatment received in the short term period.|||percentage of participants||95% Confidence Interval|Number
2732195|NCT01001559|Secondary|Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.~Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence."|60 days|All participants|||Days||Inter-Quartile Range|Median
2732159|NCT01001832|Primary|Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.|||units on a scale||95% Confidence Interval|Mean
2732160|NCT01001832|Primary|Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period|The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have >=20%, >=50% or >=70%, respectively, fewer tender joints and >=20%, >=50% or >=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period.|Day 533|m=Long term period participants who received at least one dose of drug and were ACR responders in short term period: ACR20= 49, 46; ACR50= 35, 34; ACR70= 20, 16. n=number of paticipants with sustained ACR response at Day 533. n/m = percentage|||percentage of participants||95% Confidence Interval|Number
2732161|NCT01001832|Secondary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; GGT (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732162|NCT01001832|Secondary|Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732163|NCT01001832|Secondary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; aspartate aminotransferase (AST) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; alanine aminotransferase(ALT) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; Gamma glutamyltransferase(GGT) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732164|NCT01001832|Secondary|Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732165|NCT01001832|Secondary|Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732196|NCT01001559|Primary|Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.~Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline."|60 days|All participants|||Participants|||Number
2732166|NCT01001832|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 533 and up to 56 days following last dose in Long-Term period|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732167|NCT01001832|Secondary|Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2732168|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period|EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP<2.6.|Day 533|m=All treated participants in the long term period in the analysis with available LDAS and REM data. n=number of participants with either EULAR-defined LDAS response or EULAR-defined REM response. n/m = percentage of participants|||percentage of participants||95% Confidence Interval|Number
2732169|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period|EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (<) 2.6.|Day 169|m=All randomized participants who received at least 1 dose of study medication and with LDAS and REM data available. n= number of participants with LDAS and REM. n/m=percentage of participants.|||Percentage of participants||95% Confidence Interval|Number
2732170|NCT01001832|Secondary|Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value.|Baseline to 6 Months|All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.|||Units on a scale||95% Confidence Interval|Mean
2732171|NCT01001832|Secondary|Percentage of Participants With HAQ Response at Day 169 in the Short Term Period|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline.|Day 169|N=All randomized participants who received at least 1 dose of study medication in short term period. n=number of participants with HAQ response in short term period; n/N=percentage of participants: 41/59 and 30/59|||Percentage of participants||95% Confidence Interval|Number
2732172|NCT01001832|Secondary|Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.|Baseline to Day 169|All participants who received at least 1 dose of study medication were analyzed.|||Units on a scale||95% Confidence Interval|Mean
2732173|NCT01001832|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period|The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have >=50% or >=70%, respectively, fewer tender joints and >=50% or >=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation).|Day 169|m= All participants who received at least 1 dose of study medication in short term period and had data available. n= participants with ACR50 or ACR70 response in the short term period. n/m= percentage|||Percentage of participants||95% Confidence Interval|Number
2732197|NCT01001546|Primary|The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)||3 months post treatment||||percentage of participants|||Number
2732226|NCT01001429|Primary|Intraoperative Hemodynamic Stability|systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm|Intraoperative up to 120 min||||mm/Hg||Inter-Quartile Range|Mean
2736198|NCT00976599|Primary|Plasma Level of Matrix Metallopeptidase (MMP13)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of MMP13 was not performed as valid assay for MMP13 was not available.||||||
2732174|NCT01001832|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period|The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.|Day 169|N= All randomized participants who received at least 1 dose of study medication and were analyzed. n=number of participants with ACR20 response at Day 169: 54, 49, respectively. n/N= percentage: 54/59; 49/59.|||Percentage of participants||95% Confidence Interval|Number
2732175|NCT01001806|Primary|Peak Aqueous Penetration||day 4 of treatment|Protocol specified enrollment of 126 subjects and analysis was performed per protocol.|||ng/ml||Standard Deviation|Mean
2732176|NCT01001767|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery|Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.|baseline and week 24|Randomized to have equal number in both groups|||percent change||Standard Deviation|Mean
2732177|NCT01001702|Secondary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.|Baseline, Up to 72 months|All participants with available assessment.|||Participants|||Number
2732178|NCT01001702|Secondary|Number of Participants Showing Significant Weight Gain or Loss|Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.|||Participants|||Number
2732179|NCT01001702|Secondary|Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations|"A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.~Clinically significant ECGs were defined as:~Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.~Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.~Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett's formula), QTcF (QT interval corrected Fridericia's formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline."|Baseline, Up to 72 months|Participants with at least one post-baseline numeric result for the given parameter.|||Participants|||Number
2732180|NCT01001702|Secondary|Number of Participants With Clinically Significant Blood Pressure|"Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.~Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.~A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline."|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.|||Participants|||Number
2732181|NCT01001702|Secondary|Number of Participants With Clinically Significant Heart Rate|Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.|||Participants|||Number
2732182|NCT01001702|Secondary|Number of Participants With Clinical Significant Laboratory Tests|"Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.~Clinically significant values are defined as the following:~Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].~Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.~Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)]."|Baseline, Up to 72 Months|Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.|||Participants|||Number
2732183|NCT01001702|Secondary|Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score|"The rater or investigator answered the following question:~Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement"|Baseline, Last Visit (Up to 72 Months)|Participants with baseline assessment and at least one post-baseline measurement for analysis.|||Score on a scale||Standard Deviation|Mean
2736336|NCT00975975|Primary|Grade 3-4 Acute GVHD Rate|The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment|||percentage of participants||95% Confidence Interval|Number
2732184|NCT01001702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths|"An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.~An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.~Additional information about Adverse Events can be found in the Adverse Event section."|Up to 72 months|Safety population included all participants who received at least one dose of study drug.|||Participants|||Number
2732185|NCT01001598|Secondary|The Gene Expression Profile of Progenitor Cells in Response to Danazol, Both to Predict Responsiveness and to Screen for Small Molecules That Show a Profile Similar to That of Responsive Patients|The gene expression profiles were planned to be run on bone marrow samples collected from patients at baseline and 24 weeks but bone marrow was never collected at 24 weeks.|Baseline and 24 weeks|Baseline samples were too noisy to determine gene expression.||||||
2732186|NCT01001598|Secondary|The Optimal Dose and Number of Participants With Hematologic Response Rate in Fanconi Anemia (FA) and Dyskeratosis Congenita (DC) Patients Receiving Danazol Therapy|"The optimal dose could not be calculated because the number of participants needed to do this were not enrolled. Hematologic response rate (HR) was calculated for each participant at Week 12, 18, and 24. HR was defined by hemoglobin (Hg), platelets or neutrophil response. Please find the evaluation criteria used below:~Hemoglobin response: Hgb≥8 g/dL if baseline Hgb≤7 g/dL, or Hgb rise ≥1 g/dL from baseline if baseline Hgb>7 g/dL. No RBC transfusion during the 8 weeks prior to response evaluation.~Platelet response: Platelet count ≥30,000/ μL if baseline platelet count ≤20,000/ μL, or platelet count rise >10,000/ μL from baseline if baseline platelet count >20,000/ μL. No platelet transfusion during the 4 weeks prior to response evaluation.~ANC response: ANC count ≥1,000/ μL if baseline ANC count ≤500/ μL, or ANC count rise >500/ μL from baseline if baseline ANC count >500/ μL."|12, 18 and 24 weeks|2 participants withdrew before HR could be assessed.|||Participants|||Count of Participants
2732187|NCT01001598|Primary|Number of Participants With Toxicity Associated With Danazol Therapy: Virilization, and/or New or Progressive Evidence of Either Hepatic or Renal Toxicity at a Grade II Level Using National Cancer Institute Common Toxicity Criteria (NCI-CTC).|All toxicities were collected and adjudicated to definitely-related, possibly-related, or unrelated to the treatment.|48 weeks (24 weeks treatment and 24 weeks extension phase)|4 patients with Fanconi anemia and 1 with dyskeratosis congenita|||Participants|||Count of Participants
2732188|NCT01001572|Secondary|Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
2732189|NCT01001572|Secondary|Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
2732190|NCT01001572|Secondary|Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint|The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
2732191|NCT01001572|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.|||mmHg||Standard Error|Least Squares Mean
2732192|NCT01001572|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.|||mmHg||Standard Error|Least Squares Mean
2732193|NCT01001559|Secondary|Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications||60 days||||Alterations in antidepressant therapy|||Number
2732194|NCT01001559|Secondary|Number of Hospitalizations Due to MDD|Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts|60 days||||Hospitalizations due to MDD|||Number
2733108|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2732198|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Ventromedial Prefrontal Cortex; vmPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
2732199|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Posterior Cingulate Cortex; PCC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
2732200|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Dorsal Cingulate/Medial Prefrontal Cortex; MF/CG)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
2732201|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Left Dorsolateral Prefrontal Cortex; Left DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
2732202|NCT01001520|Secondary|Subjective Symptoms: Withdrawal Symptoms|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales. The MNWS-N (right now/at the moment) was assessed during each fMRI scanning session visit (Day 8).~To assess if tolcapone (vs. placebo) affect withdrawal symptoms, we statistically analyzed the average of the total MNWS scores across, all 20 subjects, for each study medication period. Specifically, we analyzed for significant differences between reported withdrawal symptoms while taking tolcapone vs. taking placebo."|Day 8 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||units on a scale||Standard Deviation|Mean
2732209|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment|Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Percentage of participants|||Number
2732210|NCT01001494|Secondary|Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Liters||Standard Error|Least Squares Mean
2732275|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Full Range|Median
2732203|NCT01001520|Secondary|Subjective Symptoms: Cigarette Craving|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). Specifically, subjects completed the QSU-B at day 5, day 8 (fMRI scanning session 1), day 26 (day 5 of study medication period 2), and day 29 (day 8 of study medication period 2; fMRI scanning session 2).~The range of possible scores on the QSU-B is 10-70, with higher values indicating an increased craving for cigarettes. This range of scores represent a total score; there are no subscales.~While the QSU-B was collected at all in-person sessions, we only analyzed the scores collected from the fMRI scanning sessions of each period (day 8 and day 29). To analyze, we averaged the total scores across all 20 subjects from each fMRI scanning session and statistically analyzed for significant differences between these two averages. This was a within-subject analysis."|Day 8 (fMRI scanning session) of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects|||units on a scale||Standard Deviation|Mean
2732204|NCT01001520|Secondary|Subjective Symptoms: Smoking Behavior|In order to determine if tolcapone (vs. placebo) would affect subject smoking behavior, we collected the daily number of cigarettes each subject smoked from Days 1 through 7 during each study medication period. This allowed us to calculate the average number of daily cigarettes smoked, across all subjects, during each study medication period (i.e., the average number of cigarettes/day smoked while all subjects took tolcapone and the average number of cigarettes/day smoked while all subjects took placebo). Then, we statistically assessed if there was a significant difference between these averages.|Days 1 through 7 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||Average number of cigarettes smoked/day||Standard Deviation|Mean
2732205|NCT01001520|Secondary|Cognitive Performance: Reaction Time|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.~Specifically, we tested whether subjects, while taking tolcapone, would display increased average reaction time (in milliseconds) during the N-back working memory task compared to their performance while they took the placebo. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||Milliseconds||Standard Error|Mean
2732206|NCT01001520|Secondary|Cognitive Performance: Accuracy|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.~Specifically, we tested whether subjects, while taking tolcapone, would display increased accuracy during the N-back working memory task compared to their performance while they took the placebo. We measured accuracy by counting the absolute number of true positives scored (the number each subject got correct during the task). This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||Number of true positives||Standard Error|Mean
2732207|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Right Dorsolateral Prefrontal Cortex; Right DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||BOLD signal||Standard Error|Mean
2732208|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment|Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Percentage of participants|||Number
2732211|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment||Baseline and Week 12|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Liters||Standard Error|Least Squares Mean
2732213|NCT01001442|Secondary|Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS)|"Progressive disease~Requires any one or more of the following:~Increase of ≥ 25% from baseline in~Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL) (increases of ≥ 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL).~Urine M-component and/or (the absolute increase must be ≥ 200mg/24h).~Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL.~Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%).~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder."|Starting with first study drug administration until death or 3 years from first study treatment.|The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34).|||months||95% Confidence Interval|Median
2732214|NCT01001442|Secondary|Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria|sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level <100mg per 24h,>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still >200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD.|On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months).|ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).|||Participants|||Count of Participants
2732215|NCT01001442|Secondary|Multi-dose Pharmacokinetics Properties of BT062 - Cmax|"Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate.~Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4."|Starting with first study drug administration until 30-day follow-up visit (average 4.99 months).|"Safety Population: The Safety population included all subjects who were enrolled and received at least~1 dose of BT062 (n = 35)."|||ng/ml||Full Range|Median
2732216|NCT01001442|Secondary|Qualitative and Quantitative Toxicities of BT062|"Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results.~The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs)."|Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)|Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).|||Participants|||Count of Participants
2732217|NCT01001442|Primary|Maximum Tolerated Dose (MTD)|"The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD.~Only DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions.~Three subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available.~In case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level.~If 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped.~The highest dose level at which < 2 of 6 subjects experienced a DLT is defined as the MTD."|First 28-day cycle||||mg/m²|||Number
2732218|NCT01001442|Primary|Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT|The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.|Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)|"The Safety population included all subjects who were enrolled and received at least~1 dose of BT062 (n = 35)."|||Participants|||Count of Participants
2732219|NCT01001429|Secondary|Hemodynamic Stability Post Operatively in PACU|heart rate recorded at 30 min intervals in PACU up to 120 min|PACU to 2 hours post op||||beats per minute||Inter-Quartile Range|Mean
2732220|NCT01001429|Secondary|Post Operative Hemodynamic Stability|blood pressure documented at 30 minute intervals in PACU up to 120 min|2 hours in PACU||||mmHg||Inter-Quartile Range|Mean
2732221|NCT01001429|Secondary|Patient Satisfaction|1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent|measured prior to discharge up to 2 hours||||units on a scale||Full Range|Mean
2732222|NCT01001429|Secondary|Surgeon Satisfaction for Adequate Sedation at Completion of Procedure|surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent|immediately following the completion of the procedure up to one hour||||units on a scale||Full Range|Mean
2732223|NCT01001429|Secondary|Surgeon Satisfaction for Adequate Sedation|1=very poor, 2=poor,3=fair, 4=good, 5=excellent|at 10 minutes into the procedure||||units on a scale||Full Range|Mean
2732224|NCT01001429|Primary|Intraoperative Heart Rate Stability|Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm|Intraoperative up to 120 min||||beats per minute||Full Range|Mean
2732225|NCT01001429|Primary|Intraoperative Respiratory Stability|respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm|Intraoperative up to 120 min||||breaths per minute||Full Range|Mean
2732227|NCT01001429|Secondary|"Time to Achieve Street Fitness"|Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.|for 2 hours post-operatively in Post Anesthesia Care unit|Subjects meet criteria for discharge based upon the assessment from a professional independent of the study|||minutes||Inter-Quartile Range|Mean
2732228|NCT01001429|Primary|Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)|Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.|Intraoperative up to 120 min||||units on a scale||Inter-Quartile Range|Mean
2732229|NCT01001403|Primary|Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)|"Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. Moderate PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a severe form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs."|during 5 min after reperfusion of liver graft||||participants|||Number
2732230|NCT01001390|Secondary|Number of Participants With Improvement in Gait Efficiency While Using an AFO|The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables.|One month after baseline evaluation|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.||||||
2732231|NCT01001390|Primary|Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.|Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace.|Baseline|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.||||||
2732232|NCT01001377|Secondary|Number of Participants With Adverse Events (AEs)|Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.|From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.|Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.|||participants|||Number
2732233|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Functional Well-being Scale Score|"The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from 0 to 4 representing Not at All through to Very Much True. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more)."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2732234|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Physical Well-being Scale Score|"The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from 0 to 4 representing Not at All through to Very Much True. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more)."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2732235|NCT01001377|Secondary|Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score|"The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from 0 to 4 representing Not at All through to Very Much True. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more)."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2732292|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L/hr/m^2||Standard Deviation|Mean
2732236|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)|"The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as Worst imaginable health state and 100 labeled as Best imaginable health state. The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data|||scores on a scale||95% Confidence Interval|Least Squares Mean
2732237|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2732238|NCT01001377|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set|||months||95% Confidence Interval|Median
2732239|NCT01001377|Secondary|Time to Response|Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response|||months||Inter-Quartile Range|Median
2732240|NCT01001377|Secondary|Duration of Response|Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response|||months||95% Confidence Interval|Median
2732241|NCT01001377|Secondary|Objective Response|Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1.|||percentage of participants||95% Confidence Interval|Number
2732242|NCT01001377|Secondary|Progression-free Survival|"Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.~Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set|||months||95% Confidence Interval|Median
2732243|NCT01001377|Primary|Overall Survival|Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.|||months||95% Confidence Interval|Median
2732244|NCT01001325|Primary|Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab|Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)|day +7 post seasonal influenza vaccination (or placebo) to end of study||||participants||95% Confidence Interval|Number
2732255|NCT01001299|Primary|Tmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||hours||Full Range|Median
2732245|NCT01001299|Secondary|Progression-Free Survival (PFS)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in participants without disease progression were to be considered to be a PFS event on the date of death. Participants who neither progressed nor died were to be censored on the date of the last evaluable tumor assessment prior to the data cutoff date. PD, as assessed by investigator, was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
2732246|NCT01001299|Secondary|Time to Response|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed CR or PR (as assessed by investigator), whichever occurred first. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
2732247|NCT01001299|Secondary|Duration of Response|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those participants whose best overall response was CR or PR, as assessed by investigator. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
2732248|NCT01001299|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than [<] 10 millimeter [mm]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|Efficacy population included all enrolled participants who received any vemurafenib and had at least one post-baseline tumor assessment.|||percentage of participants|||Number
2732249|NCT01001299|Primary|CL/F of Probe Parent Drugs on Day 20|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||mL/h||Standard Deviation|Mean
2732250|NCT01001299|Primary|Apparent Plasma Clearance (CL/F) of Probe Parent Drugs on Day 1|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||milliliters per hour (mL/h)||Standard Deviation|Mean
2732251|NCT01001299|Primary|t1/2 of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.|||hours||Standard Deviation|Mean
2732252|NCT01001299|Primary|Apparent Elimination Half-Life in Plasma (t1/2) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.|||hours||Standard Deviation|Mean
2732253|NCT01001299|Primary|Trough Plasma Concentration (Cmin) of Vemurafenib||Before morning dose (0 hour) on Day 19|Primary PK analysis population. Here, number of participants analyzed signifies participants with evaluable data for this outcome.|||mcg/mL||Standard Deviation|Mean
2732254|NCT01001299|Primary|Tmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.|||hours||Full Range|Median
2737285|NCT00969332|Secondary|Platelet Counts at the End of the Study - Risk of Bleeding|platelet counts at the end of the study|24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)||||x10^3 cells/mL||Standard Deviation|Mean
2732256|NCT01001299|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||hours||Full Range|Median
2732257|NCT01001299|Primary|Cmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2732258|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ng/mL||Standard Deviation|Mean
2732259|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2732260|NCT01001299|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8, 12, and 24 Hours (AUC[0-8], AUC[0-12], AUC[0-24]) of Vemurafenib|Area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to 8, 12, and 24 hours (AUC[0-8], AUC[0-12], AUC[0-24], respectively).|0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
2732261|NCT01001299|Primary|AUC(0-last) and AUC(0-inf) of Probe Parent Drugs and Their Metabolites on Day 20|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ng*hr/mL||Standard Deviation|Mean
2732262|NCT01001299|Primary|AUC(0-last) and Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Probe Parent Drugs and Their Metabolites on Day 1|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||nanograms*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2732263|NCT01001299|Primary|Geometric Mean Ratio of AUC(0-last) and Cmax of Metabolites of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of AUC(0-last) and Cmax of metabolites of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) and Cmax (Day 20/Day 1) for each of the 4 probe drug metabolites is reported (paraxanthine [caffeine metabolite], dextrorphan [dextromethorphan metabolite], OH-midazolam [midazolam metabolite], OH-omeprazole (omeprazole metabolite); S-warfarin does not have a metabolite).|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for paraxanthine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120, dextrorphan 0.5, 1.5, 2, 12, 18, 48, OH-midazolam 0.08, 0.25, 0.5, 0.75, 2, 10, OH-omeprazole 0.5, 1.5, 2, 2.5, 12, 18 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ratio||90% Confidence Interval|Geometric Mean
2732264|NCT01001299|Primary|Geometric Mean Ratio of Maximum Plasma Concentration (Cmax) of Probe Parent Drugs|To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of Cmax of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of Cmax (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ratio||90% Confidence Interval|Geometric Mean
2732274|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
2732265|NCT01001299|Primary|Geometric Mean Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Observed Sampling Time (AUC[0-last]) of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90 percent (%) confidence interval (CI) of AUC(0-last) of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary pharmacokinetic (PK) population: all participants who received all planned doses of vemurafenib without dose modification/interruption up to Day 25 and all doses of 5 cocktail probes, without major protocol violation. Number of Participants Analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ratio||90% Confidence Interval|Geometric Mean
2732266|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
2732267|NCT01001234|Secondary|Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
2732268|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
2732269|NCT01001234|Primary|Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
2732270|NCT01001221|Primary|Objective Response Rate With MTD|"Objective response was defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the treatment period, based on RECIST 1.1, as assessed by the Investigator.~CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.~The objective response rate (ORR) was to be calculated as the proportion of participants with confirmed objective response relative to the total number of participants in the analysis population. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months|||||||
2732271|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC|Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure.|Day 1 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) and Day 8 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion)|Enrolled participants who received at least 1 part of a dose of study treatment and had valid Day 1 and Day 8 PK samples. Valid PK samples included at least 1 post treatment analyzable PK sample and no prohibited concomitant medications.|||ratio||Full Range|Mean
2732272|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
2732273|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Standard Deviation|Mean
2732276|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample and with no prohibited concomitant medications.|||ng/ml||Standard Deviation|Mean
2732277|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||ng*hr/ml||Standard Deviation|Mean
2732278|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Standard Deviation|Mean
2732279|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
2732280|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Full Range|Median
2732281|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng/ml||Standard Deviation|Mean
2732282|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L/m^2||Standard Deviation|Mean
2732283|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L/hr/m^2||Standard Deviation|Mean
2732284|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L||Standard Deviation|Mean
2732285|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L/hr||Standard Deviation|Mean
2732286|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||ng*hr/ml||Standard Deviation|Mean
2732287|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||hours (hr)||Standard Deviation|Mean
2732288|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
2732289|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours (hr)||Full Range|Median
2732290|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;~Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng/ml||Standard Deviation|Mean
2732291|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L/m^2||Standard Deviation|Mean
2732293|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L||Standard Deviation|Mean
2732294|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L/hr||Standard Deviation|Mean
2732295|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||hours||Standard Deviation|Mean
2732296|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||ng*hr/ml||Standard Deviation|Mean
2732297|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
2732298|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours (hr)||Full Range|Median
2732299|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;~Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined.|||ng/ml||Standard Deviation|Mean
2732300|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assays could not be used for Vss/BSA.|||L/m^2||Standard Deviation|Mean
2732301|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL/BSA.|||L/hr/m^2||Standard Deviation|Mean
2732302|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assay could not be used for Vss.|||L||Standard Deviation|Mean
2732303|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL.|||L/hr||Standard Deviation|Mean
2732304|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined|||hours (hr)||Standard Deviation|Mean
2732305|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)|Area under the plasma concentration versus time curve extrapolated to infinity|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for AUC.|||ng*hr/ml||Standard Deviation|Mean
2732306|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)|Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t.|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
2732307|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined|||hours (hr)||Full Range|Median
2732318|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 12|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 12. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2732308|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.~Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis."|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population: All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample, and with no prohibited concomitant medications|||ng/ml||Standard Deviation|Mean
2732309|NCT01001221|Post-Hoc|Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|"Participant Best response was assessed by investigator using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1:~Complete response (CR): Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm:~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion;~Progressive disease (PD): >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions;~Stable disease (SD): not a CR, PR or PD."|Up to a maximum of 22 cycles (median 4 cycles)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment.|||participants|||Number
2732310|NCT01001221|Secondary|Participants With Adverse Events|"Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.~Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.~NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling."|from first dose of study medication up to 30 days after the last dose of study medication (maximum follow-up of 68 weeks)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment|||participants|||Number
2732311|NCT01001221|Secondary|Duration of Response With MTD|"Duration of Response (DR) was defined as the time from the first documentation of RECIST-defined objective tumor response to the first documentation of RECIST-defined objective tumor progression or death.~Median DR was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months|||||||
2732312|NCT01001221|Secondary|Time To Progression With MTD|"Time to progression (TTP) was defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression (>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions).~Median TTP was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months|||||||
2732313|NCT01001221|Primary|Participants With Dose Limiting Toxicities During Dose Escalation|Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4).|Day 1 to Day 21 of the first treatment cycle|"DLT population: All participants who completed assessments for DLT evaluation for Cycle 1 and either:~received study treatment during Cycle 1 and had DLT or~did not have DLT and received a full dose of study treatment (no delay/reduction) during Cycle 1 and did not receive hematopoietic growth factors."|||participants|||Number
2732314|NCT01001208|Secondary|Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24|A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 24 score; a positive change from Baseline therefore indicates improvement.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of BSA||Standard Deviation|Mean
2732315|NCT01001208|Secondary|Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12|A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 12 score; a positive change from Baseline therefore indicates improvement.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of BSA||Standard Deviation|Mean
2732316|NCT01001208|Secondary|PASI 90 Response at Week 24|Percentage of participants achieving at least a 90% decrese (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2732317|NCT01001208|Secondary|PASI 90 Response at Week 12|Percentage of participants achieving at least a 90% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2733164|NCT00996840|Primary|Mean Clinical Chemistry Parameters-Blood pH at Screening|Absolute values of Blood pH at screening were reported as clinical chemistry parameter.|Screening|All subject population. Only those participants available at the specified time points were analyzed.|||pH Units||Standard Deviation|Mean
2732319|NCT01001208|Secondary|PASI 75 Response at Week 12|Percentage of participants achieving at least a 75% decrease (i.e. improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used|||Percentage of participants|||Number
2732320|NCT01001208|Secondary|PASI 50 Response at Week 12|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2732321|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 24|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 24. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2732322|NCT01001208|Secondary|PASI 50 Response at Week 24|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2732323|NCT01001208|Primary|PASI 75 Response at Week 24|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
2732324|NCT01001195|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 29 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2732325|NCT01001169|Secondary|Number of Subjects With Normal or Abnormal Values of Haematological Parameters|"Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC).~Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Days 0, 7 and 42|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
2732326|NCT01001169|Secondary|Number of Subjects With Normal or Abnormal Biochemical Levels|"Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN).~Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Days 0, 7 and 42|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732327|NCT01001169|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732328|NCT01001169|Secondary|Number of Subjects With Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732329|NCT01001169|Secondary|Number of Subjects With Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732905|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732330|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to 84 days (Days 0-83) after the first vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732331|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location, muscle aches, shivering, sweating, and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C - ≤ 40.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732332|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732333|NCT01001169|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain [child below (<) 6 years] = cried when limb was moved/spontaneously painful. Grade 3 pain [child equal to or above (≥) 6 years] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on The Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2732334|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
2732335|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732336|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
2732337|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
2732338|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||95% Confidence Interval|Geometric Mean
2732339|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2732340|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
2732341|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732342|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
2732343|NCT01001169|Secondary|SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5."|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
2732344|NCT01001169|Secondary|SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||95% Confidence Interval|Geometric Mean
2732345|NCT01001169|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2732346|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%."|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
2732347|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732348|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%."|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
2732367|NCT01001104|Secondary|Change From Baseline in Total Body Weight at 12 Weeks|Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
2732349|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%."|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
2732350|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732351|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
2732352|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
2732353|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||95% Confidence Interval|Geometric Mean
2732354|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2732355|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
2732356|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|"The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732357|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
2732458|NCT01000649|Secondary|Pulmonary Function : Change From Baseline in Tidal Volume|"Change from Baseline in tidal volume was observed at each time-point.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||mL/kg||Standard Deviation|Mean
2732358|NCT01001169|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for GMFR was > 2.5."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||97.5% Confidence Interval|Geometric Mean
2732359|NCT01001169|Primary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was > 70%.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732360|NCT01001169|Primary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.~The CHMP criterion was fulfilled if the point estimate for SCR was > 40%."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732361|NCT01001169|Primary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||97.5% Confidence Interval|Geometric Mean
2732362|NCT01001169|Primary|Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value|"The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance."|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
2732363|NCT01001104|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period|Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage of participants|||Number
2732364|NCT01001104|Secondary|Steady-State Concentrations of LY2189265|Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
2732365|NCT01001104|Secondary|Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks|HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage beta-cell function||95% Confidence Interval|Least Squares Mean
2732366|NCT01001104|Secondary|Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks|HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage insulin sensitivity (%S)||95% Confidence Interval|Least Squares Mean
2732735|NCT00998790|Primary|Percentage of Subjects in Each Range of Pads Per Day Use|Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day|24 months|93 subjects who completed the final 24 month follow-up visit|||percentage of subjects|||Number
2732368|NCT01001104|Secondary|Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2732369|NCT01001104|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks|Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2732370|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks|Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).|||percentage of participants|||Number
2732371|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks|Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).|||percentage of participants|||Number
2732372|NCT01001104|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2732373|NCT01001078|Secondary|Airway Manipulation and Blood on Device at Removal||During and after anesthesia when the device is removed.||||participants|||Number
2732374|NCT01001078|Secondary|Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)|Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.|On the day following surgery|"5 participants were lost to follow-up and 4 participants had the crossover device or were intubated in the I-Gel group.~4 participants were lost to follow-up and 3 participants had the crossover device or were intubated in the LMA Supreme group (one of participants was lost to follow-up and had the crossover device or was intubated)"|||participants|||Number
2732375|NCT01001078|Secondary|Number of Participants With Successful Attempts to Introduce the Devices||At the beginning of anesthesia before the beginning of the surgery.||||participants|||Number
2732376|NCT01001078|Secondary|Time Needed to Secure the Airway||From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.||||seconds||Standard Deviation|Mean
2732377|NCT01001078|Secondary|Measure of the Peak Airway Pressure||After introduction of the SAD before the beginning of the surgery.||||cm H20||Standard Deviation|Mean
2732378|NCT01001078|Primary|Measure of the Airway Leak Pressure||After introduction of the supraglottic device before the beginning of the surgery.||||cmH2O||Standard Deviation|Mean
2732379|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colcrys™|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose||||ng*hr/mL||Standard Deviation|Mean
2732380|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Colcrys™|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose||||ng*hr/mL||Standard Deviation|Mean
2732381|NCT01001052|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2732382|NCT01000987|Primary|Cognitive Function as Measured by Omissions on the CPT|"Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with stop and go targets that appear on a computer screen. They are told to press the space bar (respond) to go targets and to avoid pressing the space bar when stop targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324)."|Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.||||Number of Omissions||Standard Error|Mean
2732459|NCT01000649|Secondary|Pulmonary Function : Change From Baseline in PaO2/FiO2|"Change from Baseline in PaO2/FiO2 was observed at each time-point.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||Ratio||Standard Deviation|Mean
2732383|NCT01000974|Secondary|Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|pre-booster and one month after booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||EL.U/mL||95% Confidence Interval|Geometric Mean
2732384|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.|||Subjects|||Number
2732385|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to Day 30) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.|||Subjects|||Number
2732386|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.|||Subjects|||Number
2732387|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.|||Subjects|||Number
2732388|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.|||Subjects|||Number
2732389|NCT01000974|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.|Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Subjects|||Number
2732390|NCT01000974|Secondary|Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8|Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated.|Prior to booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Subjects|||Number
2732391|NCT01000974|Secondary|Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8|Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers.|Prior to the booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2732392|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL|Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Subjects|||Number
2732393|NCT01000974|Secondary|Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL|The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|Prior to booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||Subjects|||Number
2732736|NCT00998790|Primary|Percentage of Subjects in Each Range of Pads Per Day Use|Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day|Baseline||||percentage of subjects|||Number
2732394|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL|Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).|Prior to the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
2732395|NCT01000974|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2732396|NCT01000974|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values|The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732397|NCT01000974|Secondary|Antibody Titers for Poliovirus Types 1, 2 and 3|Antibody titers were given as geometric mean titers(GMTs).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2732398|NCT01000974|Secondary|Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL|Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination.|At 1 month after the last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732399|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations|Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
2732400|NCT01000974|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL|Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||Subjects|||Number
2732401|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL|Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732402|NCT01000974|Secondary|Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA|Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732403|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.|||Subjects|||Number
2732404|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 until 6 months following the last primary dose|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.|||Subjects|||Number
2732405|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) follow-up period after primary vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.|||Subjects|||Number
2732406|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed.|||Subjects|||Number
2732407|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed.|||Subjects|||Number
2732408|NCT01000974|Secondary|Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2732409|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL|Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP|At 1 month after booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||Subjects|||Number
2732410|NCT01000974|Primary|Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value|"The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity).~The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database."|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732411|NCT01000974|Primary|Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)|Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732412|NCT01000974|Primary|Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations|Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2732413|NCT01000974|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2732414|NCT01000974|Primary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2732607|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732415|NCT01000974|Primary|Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)|Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732416|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL|Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
2732417|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, AUC(0-t), Between RP103 and Cystagon®.||6 hours post dosing for Cystagon®; 12 hours post dosing for RP103.||||AUC(0-t) (min*mg/L)||Standard Deviation|Least Squares Mean
2732418|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Tmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study||||Tmax (minute)||Standard Deviation|Least Squares Mean
2732419|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Cmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study||||Cmax (mg/L)||Standard Deviation|Least Squares Mean
2732420|NCT01000961|Primary|The Steady-state White Blood Cell Cystine Levels of RP103 Compared to Cystagon®||4 weeks after the last subject has completed the study||||nmol ½ Cystine / mg protein||Standard Error|Least Squares Mean
2732421|NCT01000818|Primary|Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir|Area Under the Plasma Concentration-Time Curve and peak concentration|12 hours postdose|Eighteen HIV-Infected Patients|||µM*hr||95% Confidence Interval|Geometric Mean
2732422|NCT01000805|Secondary|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."|||kilograms (kg)||Standard Error|Least Squares Mean
2732423|NCT01000805|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."|||mm Hg||Standard Error|Least Squares Mean
2732424|NCT01000805|Secondary|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, LOCF."|||beats per minute (bpm)||Standard Error|Least Squares Mean
2732425|NCT01000805|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-blind Treatment Phase - High Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT)|Laboratory assessment of ALT/SGPT during the double-blind treatment phase. Normal ALT/SGPT ranges for males are 6.00 units per liter (U/L) (low) to 43.00 U/L (high). Normal ALT/SGPT ranges for females are 6.00 U/L (low) to 34.00 U/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.|||participants|||Number
2732426|NCT01000805|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with at least 1 post-baseline C-SSRS result.|||participants|||Number
2732427|NCT01000805|Secondary|Patient's Global Impressions of Improvement Scale (PGI-I) at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732940|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|24 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
2732428|NCT01000805|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732429|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732430|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732431|NCT01000805|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing consecutive visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
2732432|NCT01000805|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a post-baseline result, Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
2732433|NCT01000805|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732434|NCT01000805|Primary|Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732435|NCT01000805|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2732436|NCT01000727|Secondary|Number of Participants With All-cause Mortality During the Time Period for Vital Status|Number of participants who died, during the vital status time-period were reported. The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732445|NCT01000727|Secondary|Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events|CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2737307|NCT00969124|Primary|Detection Rates for Adenomas|Adenomas detected with the colonoscope alone vs. with the Retroscope|During the colonoscopy procedure (up to 1 hour, average 25 minutes)||||Adenomas|||Number
2732437|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732438|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732439|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event|All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting. The number of participants, with first occurrence of any coronary revascularization procedures, were reported.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732440|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events|CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732441|NCT01000727|Secondary|Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events|Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft [CABG]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732442|NCT01000727|Secondary|Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events|CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732443|NCT01000727|Secondary|Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events|Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732444|NCT01000727|Secondary|Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732737|NCT00998790|Primary|Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up|24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.|24 months|Baseline to 24 month measurement of 24-hour pad weight test. 113 subjects available at baseline, 89 available at 24 month follow-up.|||grams||Standard Deviation|Mean
2732446|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events|CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
2732447|NCT01000727|Primary|Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event|Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized intent-to-treat (ITT) Population consisted of all randomized participants.|||Participants|||Count of Participants
2732448|NCT01000662|Secondary|Late Radiation Toxicities Recorded According to LENT/SOMA||yearly for five years after completion of treatment|||||||
2732449|NCT01000662|Secondary|QOL (Quality of Life) Questionnaire of Patients on the 2 Different Arms of Treatment||at baseline, at the end of last week of treatment, and at 2 year Follow-up|||||||
2732450|NCT01000662|Primary|Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)|Proportion of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects|Day 1 of radiation treatment to day 60|Patients receiving either daily or weekly boost to radiation therapy|||participants|||Number
2732451|NCT01000649|Secondary|Incidence of Abnormal Changes in ECG|"The number of patients having abnormal changes in ECG variables during the trial period was presented.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||Number of patients|||Number
2732452|NCT01000649|Secondary|Mortality|"Mortality was assessed as percentage of patients dead at pre-specified time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, 7, 14, and 28|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of patients|||Number
2732453|NCT01000649|Secondary|Percentage of Days Alive and Free of Ventilation|"Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of days||Standard Deviation|Mean
2732454|NCT01000649|Secondary|Percentage of Days Alive and Free of Dialysis|"Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7, Day 14 and Day 28|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of days||Standard Deviation|Mean
2732455|NCT01000649|Secondary|Percentage of Patients Alive and Free of All Vasopressors|"Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7, Day 14 and Day 28|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of patients|||Number
2732456|NCT01000649|Secondary|Days Alive and Free of Any Organ Dysfunction at Day 7|"Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of days||Standard Deviation|Mean
2732457|NCT01000649|Secondary|Change From Baseline in Arterial Blood Gas (Lactate)|"Change from Baseline in arterial blood gas (lactate) was observed at each time-point.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||mmol/L||Standard Deviation|Mean
2732941|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|4 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
2732460|NCT01000649|Secondary|SOFA Score|"The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).~Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7, Day 14 and Day 29|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Score on a scale||Standard Deviation|Mean
2732461|NCT01000649|Secondary|Change From Baseline in Fluid Balance|"The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||mL/hour/kg||Standard Deviation|Mean
2732462|NCT01000649|Secondary|Change From Baseline in Heart Rate|"The change from Baseline in heart rate was analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||Beats per minute||Standard Deviation|Mean
2732463|NCT01000649|Secondary|Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist|"The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||µg/L||Standard Deviation|Mean
2732464|NCT01000649|Primary|Infusion Rates of Open Label NE.|"Mean open label NE infusion rate within each predefined time period.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||µg/kg/min||Standard Deviation|Mean
2732465|NCT01000649|Secondary|Change From Baseline in Interleukin-10 (IL-10)|"The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/L||Standard Deviation|Mean
2732466|NCT01000649|Secondary|Change From Baseline in Interleukin-6 (IL-6)|"The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/L||Standard Deviation|Mean
2732467|NCT01000649|Secondary|Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha|"The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/L||Standard Deviation|Mean
2732468|NCT01000649|Secondary|Change From Baseline in C-reactive Protein (CRP)|"The change from Baseline in CRP levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||mg/L||Standard Deviation|Mean
2732469|NCT01000649|Secondary|PK Parameter in Patients : Terminal Elimination Half-life|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Hour||Standard Deviation|Mean
2732470|NCT01000649|Secondary|PK Parameter in Patients : Initial Elimination Half-life|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Hour||Standard Deviation|Mean
2732471|NCT01000649|Secondary|PK Parameter in Patients : Steady State Volume of Distribution|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Litre||Standard Deviation|Mean
2732472|NCT01000649|Secondary|PK Parameter in Patients : Clearance|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Litre/hour||Standard Deviation|Mean
2732473|NCT01000649|Secondary|PK Parameter in Patients : Time to Steady State|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Hour||Standard Deviation|Mean
2732474|NCT01000649|Secondary|Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/mL||Standard Deviation|Mean
2732475|NCT01000649|Primary|Cumulative Dose of Open Label NE.|"Cumulative Dose of Open Label NE over 7 days.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.|||µg/kg||Standard Deviation|Mean
2732476|NCT01000649|Primary|Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE|"Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.|||Percentage of patients||95% Confidence Interval|Number
2732477|NCT01000649|Primary|Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)|"Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.|||Percentage of patients||95% Confidence Interval|Number
2732478|NCT01000610|Secondary|Change in Bone Density (in Participants Untreated With Bisphosphonates)|Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.|Screening and Week 84|ITT population; only participants with an assessment at both screening and Week 84 were included in the analysis.|||t-score|||Number
2732479|NCT01000610|Secondary|Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.|||percentage of participants|||Number
2732480|NCT01000610|Secondary|Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.|||percentage change from baseline||Standard Deviation|Mean
2732481|NCT01000610|Primary|Number of Participants Reporting Adverse Events (AEs)||Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks|Safety Population: Included all participants who have received any part of an infusion of study medication.|||number of participants|||Number
2732482|NCT01000506|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period|The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.|||Scores on a scale||Standard Error|Least Squares Mean
2739119|NCT00957359|Primary|HADS Depression|0-21 (higher score more depression)|1 day prior to drug administration 1||||score on a scale||Standard Error|Mean
2732483|NCT01000506|Secondary|Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.|||mL||Standard Error|Least Squares Mean
2732484|NCT01000506|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.|||Milliliters (mL)||Standard Error|Least Squares Mean
2732485|NCT01000506|Secondary|Time to First All Recorded Exacerbation|All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population|||Percentage of participants||95% Confidence Interval|Number
2732486|NCT01000506|Secondary|Number of All Recorded Exacerbations Per Year|Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population|||Exacerbations per year|||Number
2732487|NCT01000506|Secondary|Time to First Exacerbation Requiring Hospitalization or ED Visit|Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population|||Percentage of participants||95% Confidence Interval|Number
2732488|NCT01000506|Secondary|Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year|The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population|||Exacerbations per year|||Number
2732489|NCT01000506|Secondary|Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population|||Percentage of participants||95% Confidence Interval|Number
2732490|NCT01000506|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable|From randomization (Week 0) to Week 52 or early withdrawal (EW)|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.|||Exacerbations per year|||Number
2732491|NCT01000493|Secondary|Number of Participant by Maximum Suicidal Ideation, Based on the C-SSRS During and Post Treatment|The C-SSRS used to assess severity and change of suicidality by integrating both behavior and ideation and to be completed by the participants. The SSRS track change in the severity/density of suicidality. It assessed intensity of ideation (a potentially important marker of severity), specifically asking about frequency, duration, intrusiveness, controllability, and deterrents. The interview was initiated with 5 (yes/no) questions; rated on 1-5 point scale, presented in ascending order of severity, about suicidal ideation. The clinician asked 5 questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation without intent to act, active suicidal ideation with any methods (not plan) without intent to act and active suicidal ideation with specific plan and intent. Participants analyzed were number of participants with at least one C-SSRS assessment after the first dose of study medication (that is on treatment or post treatment).|Baseline, Week 1, 2, 4, 6, 8, 10, 12 and Day 14 of follow-up (approximately 14 weeks)|All subject population. Only those participants available at the time of indicated time points were analyzed.|||Participants|||Number
2732492|NCT01000493|Secondary|Number of Participant With Suicidal Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During and Post Treatment|"The C-SSRS used to assess severity and change of suicidality by integrating both behavior and ideation and to be completed by the participants. The SSRS track change in the severity/density of suicidality. The interview was initiated with 5 (yes/no) questions; rated on 1-5 point scale, presented in ascending order of severity, about suicidal ideation. If the answers to the first 2 ideation questions were yes, the clinician asked questions 3-5. If the answers to ideation questions 1 and 2 were no, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt and preparatory acts or behaviors. Participants analyzed were number of participants with at least one C-SSRS assessment after the first dose of study medication (that is on treatment or post treatment)."|Baseline, Week 1, 2, 4, 6, 8, 10, 12 and Day 14 of follow-up (approximately 14 weeks)|All subject population. Only those participants available at the time of indicated time points were analyzed.|||Participants|||Number
2732493|NCT01000493|Secondary|Change From Baseline in MSFQ Items (Diminished/Absent Libido; Arousal Difficulties; Orgasm Difficulties/Anorgasmia and Degree of Sexual Satisfaction) Scores|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent). The areas of sexual functioning included were diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia and degree of sexual satisfaction. A follow-up version of the questionnaire includes an additional sixth item of the participant's global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|All subject population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732494|NCT01000493|Secondary|Change From Baseline in MSFQ Total Score in Females|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent with total score 5-30; higher score indicating more dysfunction). The areas of sexual functioning included were total score used as a global measure of sexual dysfunction. A follow-up version of the questionnaire includes an additional sixth item of the participant's global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|Female participants from all subject population used. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732495|NCT01000493|Secondary|Change From Baseline in Massachusetts Sexual Function Questionnaire (MSFQ) Total Score and Erectile Dysfunction Score in Males|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent with total score 5-30; higher score indicating more dysfunction). The areas of sexual functioning included were total score and erectile dysfunction (males only). A total score was used as a global measure of sexual dysfunction. A follow-up version of the questionnaire includes an additional sixth item of the participant's global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|Male participants from all subject population used. All subject population defined as participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732496|NCT01000493|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score, by Visit Week|The Massachusetts CPFQ was a brief self-report scale to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1: greater than normal, 2: normal, 3: minimally diminished, 4: moderately diminished, 5: markedly diminished and 6: totally absent functioning with total score 7-42; higher score indicating more dysfunction. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732942|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|3 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
2732497|NCT01000493|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D), by Visit Week|The HAM-D was observer-rated depressive symptom rating scale to measure the severity of depressive symptoms in participants with primary depressive illness. The items were ranked on a scale of 0-4 (0: absent; 4: greatest severity) or 0-2 (0: no difficulty; 2: difficulty falling asleep). In addition to the total score (0-66; with higher score indicates more depression), the HAM-D anxiety factor score (sum of items 10, 11, 12, 13, 15 and 17) and the melancholia subscore (sum of items 1, 2, 7, 8, 10, and 13) of the 17-item HAM-D scale was analyzed. The melancholia subscale was derived from three formal psychometric criteria (calibration, ascending monotonicity and dispersion). It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2732498|NCT01000493|Secondary|Change From Baseline in the CAPS Recurrent Distressing Dreams Item (B2) at Weeks 1, 4, 8, and 12|The B2 asked participant about 'Have you ever had unpleasant dreams about the event(s)? How often in the past month?' Both frequency (0: never; 4: daily or all the time) and 'at their worst, how much distress or discomfort did these dreams cause you? Did these dreams wake you up? [If yes, ask:] What were you feeling or doing when you awoke? How long does it usually take to get back to sleep? [Listen for report of panic symptoms, yelling, posturing] intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The total score 0-8, higher scores means more severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732499|NCT01000493|Secondary|Change From Baseline in the PSQI Addendum for PTSD (PSQI-A) Global Score, by Visit Week|The PSQI-A was self-report instrument to assess disruptive nocturnal behavior (DNB) in PTSD participants with 7 types of DNB. These items include frequency of 1: hot flashes, 2: general nervousness, 3: memories or nightmares of traumatic experience, 4: severe anxiety or panic, not related to traumatic memories, 5: bad dreams, not related to traumatic memories, 6: episodes of terror or screaming during sleep without fully awakening and 7: episodes of acting out dreams, such as kicking, punching, running, or screaming. Each item was rated on a scale (0: not in the past month, 1: less than once a week, 2: once or twice a week and 3: three or more times a week) with global score range of 0-21. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732500|NCT01000493|Secondary|Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Global Score, by Visit Week|The PSQI was a self-rated questionnaire to assess sleep quality and disturbances. Individual items (19) generate 7-component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. The global score generated by addition of individual score excluding use of sleeping medication component. It contains 15 objective (about frequency of sleep disturbances and subjective sleep quality) and 4 subjective (typical bedtime, wake-up time, sleep latency and sleep duration) items with score range from 0: no to 3: severe difficulty. The PSQI Global Score ranges from 0 to 21 and a global score > 5 was suggestive of significant sleep disturbance. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732501|NCT01000493|Secondary|Change From Baseline in the DTS Cluster Sub Score|This instrument consists of 17 items which parallel the DSM criteria for PTSD. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem; 4: extreme, incapacitating) rated using 5-point scale and added to get total score. There were 8 items including guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment. The DTS cluster includes intrusion (items 1-4, 17 [score 0-40]), A/N (items 5-11 [score 0-56]) and hyperarousal (items 12-16 [score 0-40]) with lower score indicates less symptoms and higher scores means more severity, <20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and >80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732502|NCT01000493|Secondary|Change From Baseline in the Self-rated Davidson Trauma Scale (DTS), by Visit Week|This instrument consists of 17 items which parallel the DSM criteria for PTSD. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) rated using 5-point scale. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The DTS cluster includes intrusion (items 1-4, 17 [score 0-40]), avoidance/numbing (A/N; items 5-11 [score 0-56]) and hyperarousal (items 12-16 [score 0-40]). The total score (0-136) was added, lower score indicates less symptoms and higher scores means more severity, <20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732650|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732503|NCT01000493|Secondary|Change From Baseline in the Short PTSD Rating Review (SPRINT), by Visit Week|The SPRINT consists of 8 items that assess the core symptoms of PTSD, as well as related aspects of somatic malaise, stress vulnerability and functional impairment. Each item was rated on a 5 point scale (0: not at all, 1: a little bit, 2: moderately, 3: quiet a lot and 4: very much), total score 0-32; with higher scores means more severity. Also, it provided the information about how the participant feeling (as a percentage) and symptoms improved since beginning of treatment (rated on a 5 point scale [0: worse, 1: a no change, 2: minimally, 3: much and 4: very much]). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732504|NCT01000493|Secondary|Change From Baseline in the CGI-S Score, by Visit Week|The severity of illness items were rated on a 1-7 scale with 0 means not assessed (1: normal, not at all ill, 2: borderline mentally ill, 3: mildly ill, 4: moderately ill, 5: markedly ill, 6: severely ill, 7: among the most extremely ill participants). For the severity of illness item, the clinician indicated his/her assessment of the participant severity of illness considering their total clinical experience with the particular population being studied. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2732505|NCT01000493|Secondary|Percentage of Participants Responding, Based on a Clinical Global Impression- Global Improvement (CGI-I) Score of 1 or 2, by Visit Week|The global improvement items were rated on a 1-7 scale with 0 means not assessed (1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse). For the global improvement item, the clinician indicated their assessment of the participant's total improvement or worsening compared with that individual's condition at the start of the study (the Baseline visit) whether or not the change was judged to be due to drug treatment. Responder was defined as a participant who had a CGI-I score of 1 or 2 ('very much improved' or 'much improved'). It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2732506|NCT01000493|Secondary|Change From Baseline in the CAPS Hyperarousal Subscale Cluster Score at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed DSM-IV diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of hyperarousal). The re-experiencing subscale cluster score was derived from the CAPS. The possible range is 5 to 25 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2732507|NCT01000493|Secondary|Change From Baseline in the CAPS Avoidance/Numbing (A/N) Subscale Cluster Score at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed DSM-IV diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of A/N). The re-experiencing subscale cluster score was derived from the CAPS. The possible range is 7 to 35 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2732508|NCT01000493|Secondary|Change From Baseline in the CAPS Re-experiencing Subscale Cluster Score at Weeks 1, 4, 8 and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of re-experiencing). The re-experiencing subscale cluster score was derived from the CAPS. The possible range was 5 to 25 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2732509|NCT01000493|Secondary|Percentage of Participants Remitting, Based on a CAPS Total Score < 20 at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. Remitter defined as a participants who has a CAPS total score <20. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Up to Week 12|ITT population. Only those participants available at the specified time points were analyzed. The analysis method was logistic regression adjusted for Baseline CAPS total score. At a visit where there were no remitters, no analysis was performed.|||Percentage of participants|||Number
2772318|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Distractibility Observed||May-7-2008 to July -14-2010|||||||
2732510|NCT01000493|Secondary|Change From Baseline in the 17-item CAPS Total Severity Score at Weeks 1, 4, and 8|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and Week 1, 4, 8|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2732511|NCT01000493|Secondary|The Time to (Maintained) Clinical Response in Each Participants|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The time required to maintain CAPS response has been summarized.|Up to Week 12|ITT Population. Only those participants available at the indicated time points were analyzed.|||Days||Inter-Quartile Range|Median
2732512|NCT01000493|Secondary|Percentage of Participants Responding, Based on More Than Equal to (>=) 30 Percent (%) Reduction From Baseline in CAPS Total Severity Score at Weeks 1, 4, 8 and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Baseline (Day 1 pre-dose) and up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2732513|NCT01000493|Primary|Change From Baseline in the 17-item Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) Total Severity Score at Week 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and Week 12|ITT population, consisted of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2732514|NCT01000480|Secondary|Number of Participants With an Objective Tumor Response|Participants with confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria, as well as participants with a not evaluable/tumor response unknown. CR: disappearance of all tumor lesions. PR: either a) at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as a reference baseline sum LDs, or b) complete disappearance of target lesions, with persistence (not worsening) of 1 or more nontarget lesions. In either case, no new lesions appeared. SD: small changes that did not meet above criteria. PD: at least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.|Date of first dose through end of follow-up [up to 30 weeks (1 cycle=21 days)]|Intent-to-treat population: Participants who received at least 1 dose of study drug (pemetrexed or cisplatin).|||participants|||Number
2732515|NCT01000480|Secondary|Overall Survival|Overall survival (OS) was the duration from enrollment to death due to any cause. Participants who were alive were censored at the last contact.|Date of first dose to date of death (up to 35.4 months)|Intent-to-treat population: participants who received at least 1 dose of study drug (pemetrexed or cisplatin). The number of participants censored was 45.|||months||95% Confidence Interval|Median
2732528|NCT01000324|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity. They were included in the ATP analysis for the primary study, did not receive hepatitis A or B (hep A/B) vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.|||Subjects|||Number
2772319|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Irritability Observed||May-7-2008 to July -14-2010|||||||
2732516|NCT01000480|Primary|1 Year Progression Free Survival|Progression free survival (PFS) was defined as the time from study enrollment to the first observation of progressive disease (PD) or death from any cause. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined PD or death, PFS was censored at the date of the last objective progression-free disease assessment prior to start of postdiscontinuation chemotherapy. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.|Date of first dose to date of objectively determined PD or death [every cycle up to 4 cycles and then every 3 months up to 1 year (1 cycle=21 days)]|Intent-to-treat population: participants who received at least 1 dose of either study drug (pemetrexed or cisplatin). The number of participants censored was 35.|||percentage of participants||95% Confidence Interval|Number
2732517|NCT01000376|Secondary|Safety of Eribulin Administered Alone or Coadministered With Oral Ketoconazole, as Measured by Number of Subjects With Adverse Events.||monitored throughout|||||||
2732518|NCT01000376|Primary|Mean (SD) Area Under Concentration Time Curve From Zero to Infinity (AUC 0-oo) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had AUC (0-oo) data.|||ng*hr/mL||Standard Deviation|Mean
2732519|NCT01000376|Primary|Mean (SD) Maximum Observed Concentration (Cmax) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had Cmax data.|||ng*mL||Standard Deviation|Mean
2732520|NCT01000337|Secondary|Transaminases||February 2011|||||||
2732521|NCT01000337|Primary|Changes in the M30 and M65 Markers Related to the Anesthesia Type|Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively.|preoperatively, end of surgery, 24 and 48 hours postoperatively|For an effect size of 0.20 assuming a two-sided error type I error of 0.05 and a power of 0.80, a sample size of 60 sixty patients (30 patients in each group) would be required.|||U/L||Standard Deviation|Mean
2732522|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Up to Year 20.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.|||Subjects|||Number
2732523|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.|||Subjects|||Number
2732524|NCT01000324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study|||Subjects|||Number
2732525|NCT01000324|Secondary|Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration|Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL.|At Year 18, 14 days and 30 days post challenge dose (Year 19).|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2732526|NCT01000324|Secondary|Number of Subjects With Immune Response to the Challenge Vaccine Antigen|None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19.|Before, 14 days and one month after the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.|||Subjects|||Number
2732527|NCT01000324|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity.They were included in the ATP analysis for the primary study, did not receive hepatitis A or B vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2732606|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732529|NCT01000311|Secondary|Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations|"Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination.~Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine."|From day 1 to 18 months|Analysis was performed on the safety dataset, i.e. all subjects in the exposed population who provided postbaseline safety data|||Number of subjects|||Number
2732530|NCT01000311|Secondary|Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.|One month after MenACWY-CRM toddler vaccination|Analysis was performed on the PP toddler dataset for MenACWY-CRM.|||Percentage of subjects||95% Confidence Interval|Number
2732531|NCT01000311|Secondary|Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.|||Titers||95% Confidence Interval|Geometric Mean
2732532|NCT01000311|Secondary|Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.|||Percentage of subjects||95% Confidence Interval|Number
2732533|NCT01000311|Secondary|Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.|||Percentage of subjects||95% Confidence Interval|Number
2732534|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.|||μg/mL||95% Confidence Interval|Geometric Mean
2732535|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.|One month after third dose of routine infant series vaccination|Analysis was performed on the PP datasets of infants for concomitant, pertussis and hepatitis B vaccinations|||μg/mL||95% Confidence Interval|Geometric Mean
2732536|NCT01000311|Secondary|Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|"The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.~The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age."|One month after third dose of routine infant series vaccination|Analysis was performed on the PP concomitant, pertussis and hepatitis B infant populations.|||Percentage of subjects||95% Confidence Interval|Number
2732537|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.|||Titers||95% Confidence Interval|Geometric Mean
2732943|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|2 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
2732538|NCT01000311|Secondary|Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age.~Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM."|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.|||Percentage of subjects||95% Confidence Interval|Number
2732539|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2732540|NCT01000311|Primary|Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.~The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A."|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was done on the per-protocol (PP) toddler dataset for MenACWY-CRM, i.e. the subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to database lock.|||Percentage of subjects||95% Confidence Interval|Number
2732541|NCT01000285|Secondary|Effects of HTLV-1 Integration Sites After Treatment||6 months||||number of integration sites||Standard Error|Mean
2732542|NCT01000285|Secondary|Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence||6 months||||percentage of nucleotide divergence||Standard Error|Mean
2732543|NCT01000285|Secondary|Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA||6 months||||copies/peripheral blood mononuclear cell||Standard Error|Mean
2732544|NCT01000285|Secondary|Relation of NFκB Gene Expression Profile on Response|Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated.|6 months|Average RPKM values normalized to Patient A before therapy.|||fold expression||Standard Error|Mean
2732545|NCT01000285|Secondary|Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads||6 months||||copies/peripheral blood mononuclear cell||Standard Error|Mean
2732546|NCT01000285|Secondary|Time to Progression|-The progression definitions used for this study are from the 2007 Cheson criteria.|Up to 4 years following completion of therapy|12 out of the 18 participants had a complete or partial response.|||days||Full Range|Median
2732547|NCT01000285|Primary|Efficacy of Treatment as Measured by Best Overall Response|-The response definitions used for this study are the 2007 Cheson criteria.|Up to 4 years following completion of therapy||||participants|||Number
2732548|NCT01000285|Primary|Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|Up to 30 days after completion of treatment||||participants|||Number
2732549|NCT01000155|Secondary|γ-globin to β-globin Ratio|Levels of peripheral blood γ-globin to β-globin messenger RNA were estimated based on established methods. The ratio of γ-globin to β-globin was then calculated.|Measured at baseline and end of treatment, up to 16 weeks.|The analysis dataset is comprised of all treated patients.|||Change in γ-globin to β-globin ratio||Full Range|Median
2732550|NCT01000155|Secondary|F-Cell Percentage Level|F-cell percentage levels were estimated based on established methods.|Measured at baseline and end of treatment, up to 16 weeks.|The analysis dataset is comprised of all treated patients.|||F-cell percentage||Full Range|Median
2732551|NCT01000155|Primary|Percent Fetal Hemoglobin (HbF%) Induction Success Rate|Success will be defined by comparing the maximum HbF% on study drug to the HbF% at baseline. An absolute increase in HbF% of 4% of more, or an increase to 100% or more of baseline in patients with HbF under 4% at baseline will be considered a success. HbF% induction success rate is calculated as the count of successes divided by the count of patients in the analysis population.|HbF% was measured at baseline and weekly on treatment. Median duration of treatment was 3 months.|The analysis dataset is comprised of all treated patients.|||proportion of patients||90% Confidence Interval|Number
2732552|NCT01000064|Secondary|The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response.||12 weeks|Based on the analysis of neurobehavioral assessment data, complications with screening, and limited sample size, the neural mechanisms of response to Vyvanse vs placebo were not significant enough to be measured and compared by fMRI. There is no data from the fMRI to be reported because it was abandoned as an aspect of this study before analysis.||||||
2732553|NCT01000064|Secondary|Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment||12 weeks|No data were collected.||||||
2732554|NCT01000064|Primary|"Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Behaviour Rating Inventory of Executive Function-Adult Version (BRIEF-A) Organization of Materials Sub-scale."|"The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The Organization of Materials scale measures orderliness of work, living, and storage spaces.~T-scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area."|12 weeks||||t-scores||Standard Deviation|Mean
2732944|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|1 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
2732555|NCT01000064|Primary|"Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Conners Adult ADHD Rating Scale: Long Form (CAARS:L) Inattention/Memory Problems Sub-scale."|"The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the Inattention/Memory Problems sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized.~T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk."|12 weeks||||t-scores||Standard Deviation|Mean
2732556|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Wechsler Adult Intelligence Scale -- Fourth Edition (WAIS-IV) Digit Span-Backward Subtest.|Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms.|12 weeks||||units on a scale||Standard Deviation|Mean
2732557|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention."|12 weeks||||ms||Standard Deviation|Mean
2732558|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II)|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased.~Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation."|12 weeks||||t-scores||Standard Deviation|Mean
2732559|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time."|12 weeks||||t-scores||Standard Deviation|Mean
2732560|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance."|12 weeks||||ms||Standard Deviation|Mean
2732561|NCT01000051|Primary|Comparing the Efficacy of Eltrombopaq and Placebo|Comparison of the efficacy of eltrombopag and placebo in patients with thrombocytopenia post hematopoietic cell transplantation (HCT).|Baseline to Day 57||||Participants|||Count of Participants
2732562|NCT01000025|Secondary|Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0|Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0|42 Months|As treated population|||participants|||Number
2732563|NCT01000025|Secondary|Objective Response Rate|Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.|42 months|ITT|||percentage of participants||95% Confidence Interval|Mean
2732564|NCT01000025|Secondary|Progression-free Survival|progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee|42 Months|ITT|||Months||95% Confidence Interval|Median
2732565|NCT01000025|Secondary|Overall Survival in EGFR-mutant Patients|Overall survival by EGFR-mutantion subgroups|42 Months|Patients with EGFR mutation|||Months||95% Confidence Interval|Median
2732566|NCT01000025|Secondary|Overall Survival in KRAS-WT Patients|Median and 95% confidence intervals of Overall survival in KRAS-WT patients|42 Months|Patients with K-Ras mutation wild type|||Months||95% Confidence Interval|Median
2732567|NCT01000025|Primary|Overall Survival|Median and 95% confidence intervals|42 Months|ITT|||Months||95% Confidence Interval|Median
2732568|NCT00999921|Secondary|Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)|"All patients who had an increase in breast pain in the perimenstrual period were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia"|3 months|114 patients were identified as having cyclical mastalgia of whom 58 patients(37 fibroadenosis, 3 fibroadenonomas and 18 mastalgias with no lump) received Tamoxifen and 56 (36 fibroadenosis, 3 fibroadenomas and 17 mastalgias with no lump) received Evening Primrose Oil for 3 months. Good response was defined as disappearance of cyclical mastalgia.|||participants|||Number
2732569|NCT00999921|Primary|Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).|All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response|3 months|88 patients treated with Tamoxifen and 47 patients treated with Evening Primrose Oil were assessed for Cardiff Breast Pain Score. Patients with fibroadenomas and those with Grade 0 pain at the beginning of therapy were excluded from this analysis.|||participants|||Number
2743974|NCT00924781|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)||12 weeks||||Participants|||Number
2732570|NCT00999921|Primary|Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)|Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.|3 months|102(out of 127) patients receiving Tamoxifen and 99(out of 129) receiving Evening Primrose Oil were assessed for reduction in lump size. The remaining patients had mastalgia with no lump, hence were excluded from this assessment. A 60% or more reduction in lump size after completion of the therapy was considered as a satisfactory response.|||participants|||Number
2732571|NCT00999908|Secondary|Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.|||Liters||Standard Deviation|Mean
2732572|NCT00999908|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.|||Liters||Standard Deviation|Mean
2732573|NCT00999908|Primary|Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.|4 hour period following inhalation of study treatment|Per protocol population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period and who were compliant with the protocol and without any major deviation likely to affect the analysis of pulmonary function measurements.|||Liters||Standard Deviation|Mean
2732574|NCT00999830|Secondary|Safety Assessment|Adverse Events, Serious Adverse Events, physical examination and biological changes.|from screening visit to the End of Study (at each study visit)||||participants|||Number
2732575|NCT00999830|Secondary|Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment|KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.|From the start up to the end of study (15 months)||||% of occupancy||Full Range|Median
2732576|NCT00999830|Primary|Rate of Patients Achieving a Response Based on M-protein or Free Light Chains|"Response was defined:~In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;~In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis~In patients with serum M-protein < 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (<0.26 or > 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels."|From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices||||participants|||Number
2732577|NCT00999804|Secondary|Clinical Response||12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participants were not evaluable for efficacy.|||participants|||Number
2732578|NCT00999804|Secondary|Total Pathologic Complete Response|pathologic complete response was defined as no residual invasive cancer in the breast and the axillary lymph nodes.|12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.|||participants|||Number
2732579|NCT00999804|Secondary|Number of Participants With Adverse Events|the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy|12 week or 24 weeks depending on arm assignment|Participants who started the study treatment will be evaluable for safety analysis|||participants|||Number
2732580|NCT00999804|Primary|Pathologic Complete Response|"Pathologic complete response was defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy.~This outcome is based on patient's pathological report. We are not measuring the clinical response.~Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable."|12 or 24 week depending the arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.|||participants|||Number
2732581|NCT00999713|Secondary|Change in Oxygenation: Second Intervention|The Oxygenation Index after the second intervention (if applicable) is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.|48 hours after enrollment, up to 12 hours after each intervention|Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).|||index number||95% Confidence Interval|Geometric Mean
2732582|NCT00999713|Secondary|Change in Oxygenation: First Intervention|The Oxygenation Index after the first intervention is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.|48 hours after enrollment, up to 12 hours after each intervention|Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).|||index number||95% Confidence Interval|Geometric Mean
2732583|NCT00999713|Secondary|Total Duration of Stay Required|Length of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.|Admission to discharge, up to 120 days||||days||Inter-Quartile Range|Median
2732584|NCT00999713|Secondary|Ventilator Free Days (VFDs)|Number of days the patient is alive and off of the ventilator|60 days after study enrollment||||Days||Inter-Quartile Range|Median
2732585|NCT00999713|Primary|All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge|Overall mortality rate from admission to PICU discharge|Admission to PICU discharge, up to 120 days||||Participants|||Count of Participants
2732586|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 24|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.|||units on a scale||95% Confidence Interval|Mean
2732587|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 12|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.|||units on a scale||95% Confidence Interval|Mean
2732588|NCT00999661|Secondary|Change in Body Mass Index From Baseline to 24 Months|Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.|Baseline to 24 months||||kilograms per meters squared||Standard Deviation|Mean
2732589|NCT00999661|Secondary|% Excess Weight Change From Baseline to 12 Months|Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 12 months|Intent to Treat Population|||percent of excess weight at baseline||Standard Deviation|Mean
2732590|NCT00999661|Primary|Percent Excess Weight Change From Baseline to 24 Months|Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 24 months|Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.|||percent of excess weight at baseline||Standard Deviation|Mean
2732591|NCT00999609|Secondary|Visual Acuity|Measurement of the sharpness of vision, determined by the ability to read letters on a standardized chart from a specified distance.|One year (change from baseline)||||LogMAR||Standard Error|Mean
2732592|NCT00999609|Secondary|Multi-luminance Mobility Testing (Monocular)|The MLMT measures changes in functional vision, as assessed by the ability to navigate a course accurately and at a reasonable pace at different levels of environmental illumination. MLMT was assessed using the first eye at 1 or more of 7 levels of illumination, ranging from 400 lux (a brightly lit office) to 1 lux (a moonless summer night). Each light level was assigned a score code ranging from 0 to 6. A higher score indicated that a subject was able to pass the MLMT at a lower light level. A score of -1 was assigned to those who could not pass MLMT at 400 lux. The MLMT of each subject was videotaped and assessed by independent graders. The MLMT score was determined by the lowest light level at which the subject was able to pass the MLMT. The MLMT score change was defined as the difference between the score at Baseline and the score at Year 1. A positive MLMT score change from Baseline to Year 1 visit indicated that the subject was able to complete the MLMT at a lower light level.|One year (change from baseline)||||Score Change in Light Levels||Standard Deviation|Mean
2732593|NCT00999609|Secondary|Full-field Light Sensitivity Threshold (FST) Testing: White Light|Measures the light sensitivity of the entire visual field by recording the luminance at which a subject reliably reports seeing the dimmest flash.|One year (change from baseline)||||log10(cd.s/(m^2))||Standard Error|Mean
2743975|NCT00924781|Primary|Change From Baseline in Hemoglobin (Hg) Level at Week 4||4 weeks|Full analysis set|||g/dL||Standard Deviation|Mean
2732594|NCT00999609|Primary|Multi-luminance Mobility Testing (MLMT), Bilateral|The MLMT measures changes in functional vision, as assessed by the ability to navigate a course accurately and at a reasonable pace at different levels of environmental illumination. MLMT was assessed using both eyes at 1 or more of 7 levels of illumination, ranging from 400 lux (a brightly lit office) to 1 lux (a moonless summer night). Each light level was assigned a score code ranging from 0 to 6. A higher score indicated that a subject was able to pass the MLMT at a lower light level. A score of -1 was assigned to those who could not pass MLMT at 400 lux. The MLMT of each subject was videotaped and assessed by independent graders. The MLMT score was determined by the lowest light level at which the subject was able to pass the MLMT. The MLMT score change was defined as the difference between the score at Baseline and the score at Year 1. A positive MLMT score change from Baseline to Year 1 visit indicated that the subject was able to complete the MLMT at a lower light level.|One year (change from baseline)||||Score Change in Light Levels||Standard Deviation|Mean
2732595|NCT00999596|Primary|FFDM (Full Field Digital Mammography) Mammogram Scores|6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.|Day 1|This was not a statistical sample per FDA FFDM Guideline. FDA Guideline specified that a minimum of 6 film sets from the participants be analyzed. The number of participants required by FDA changed mid-study.|||FFDM Mammogram set|||Number
2732596|NCT00999544|Secondary|Respiration Depression|Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure.|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges.|||number of breaths per minute||Standard Deviation|Mean
2732597|NCT00999544|Primary|Abuse Liability Proxy|"Visual analog scale ratings (from 0-100) on the subject-rated measure of How much do you like the drug? with higher scores indicating greater abuse liability (and 100 anchored with extremely and zero indicating none anchored with none at all. Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure."|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges. The within subject data analysis does not lend itself to reporting data in the format provided below.|||units on a scale (points 0-100)||Standard Deviation|Mean
2732598|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732599|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732600|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732601|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732602|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732603|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732604|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732605|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732869|NCT00997672|Primary|Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.|Number of Adverse Events and their relative frequency in treatment groups was analyzed|the endpoint will be recorded at all visits||||number of AEs|||Number
2732608|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732609|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732610|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732611|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732612|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732613|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732614|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732615|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732616|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732617|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732618|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732619|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732620|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732621|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732622|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732623|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732624|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732625|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732626|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732627|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
2732628|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
2732629|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
2732630|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
2732631|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
2732632|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
2732633|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
2732634|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732635|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732636|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732637|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732638|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732639|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732640|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732641|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732642|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732643|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732644|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732645|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732646|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732647|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732648|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732649|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2737308|NCT00968981|Primary|Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449||0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1|PK Evaluable Population.|||hours||Full Range|Median
2732651|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732652|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732653|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732654|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732655|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732656|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732657|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732658|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732659|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732660|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732661|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732662|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732663|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732664|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2737818|NCT00965185|Secondary|Immune Function|12 month change in CD4 T-lymphocytes|Measured at baseline and 1 year|All available data were used; data were not available for one subject who completed the study.|||cells per microliter||95% Confidence Interval|Mean
2732665|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732666|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732667|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732668|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732669|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732670|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732671|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732672|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732673|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732674|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732675|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
2732676|NCT00999466|Secondary|PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
2732677|NCT00999466|Secondary|PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
2732678|NCT00999466|Secondary|PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
2732679|NCT00999466|Secondary|PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
2732680|NCT00999466|Secondary|PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
2732681|NCT00999466|Secondary|PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
2732682|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
2732683|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
2732684|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) - Pre-treatment|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
2732685|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
2732686|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
2732687|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) - Pre-treatment|Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
2732688|NCT00999167|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|Changes from Baseline to Day 56 and the Final Visit were compared between treatment groups using an ANCOVA model for the total index RBANS score ). The index score is a sum of the scores for each of the 5 individual domains (immediate memory, visuospatial/constructional, language, attention). The minimum and maximum total index scores are 40 and 160, respectively; a higher score is better.|Day 56, Final Visit (D112)|Intent to treat (ITT)|||units on a scale||Standard Error|Least Squares Mean
2732689|NCT00999167|Secondary|Time to Meeting the Primary Endpoint|Secondary efficacy endpoint. The time to the first HE episode during the treatment period was calculated using the Kaplan-Meier method. Subjects who did not experience an HE episode were censored at the time of their last asterixis assessment. Subjects who had no post-randomization data for the primary endpoint were considered to have an HE episode at Day 1.|112 Days|Intent to treat (ITT)|||Days||95% Confidence Interval|Median
2732706|NCT00999141|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14|"Participants responded to the following question during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2739120|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|6 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2732690|NCT00999167|Primary|Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0|"An HE event was defined as occurrences of either a West Haven (WH) Grade ≥2 or a WH Grade 1 and asterixis grade increase of 1 (if baseline WH = 0).~The WH criteria are widely used for rating the severity of HE and are summarized below:~Grade 1: trivial lack of awareness, euphoria or anxiety, shortened attention span, impaired performance of addition Grade 2: lethargy or apathy, minimal disorientation for time or place, subtle personality change, inappropriate behavior, impaired performance of subtraction Grade 3: somnolence to semi-stupor but responsive to verbal stimuli, confusion, gross disorientation Grade 4: coma (unresponsive to verbal or noxious stimuli)~Asterixis was assessed after arm and forearm extension along with wrist dorsiflexion for 30 seconds and assigned a grade according to the following criteria:~Grade 1: rare flaps Grade 2: occasional irregular flaps Grade 3: frequent flaps Grade 4: continuous flaps"|Part B: 112 Days|Intent to Treat (ITT)|||participants|||Number
2732691|NCT00999167|Secondary|Total Number of HE Events|Secondary efficacy endpoint. The total number of HE events during the treatment phase for subjects in the placebo and active arms.|112 Days|Intent to treat (ITT)|||HE event|||Number
2732692|NCT00999167|Primary|Part A: The Rate of AEs and Tolerability of HPN-100|Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms.|Part A: 28 days|Safety population|||Subjects|||Number
2732693|NCT00999141|Primary|Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)||Day 0 (day of surgery) through postoperative Day 14|Safety Analysis Set|||Events|||Number
2732694|NCT00999141|Other Pre-specified|Total Aspiration Volumes From Hematomas and Seromas||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||mL||Full Range|Median
2732695|NCT00999141|Other Pre-specified|Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732696|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Treatment|During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732697|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Rate of Healing|During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732698|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Quality of Flap Adherence|During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732699|NCT00999141|Other Pre-specified|Investigator Preference for Side of Face|Investigator reported outcomes data was collected for overall preference for 1 side of face|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732700|NCT00999141|Other Pre-specified|Participants' Assessment of Difference in Numbness Between Two Sides of Face|"During each postoperative visit (Day 1, 3, 7, and 14), participants were asked:~How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible?~Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score)~The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Scores on a scale||Standard Deviation|Mean
2732701|NCT00999141|Secondary|Reasons for Participants' Preferences for Side of Face|"Participants responded to the following questions during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?~If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side~Better skin sensation~Less numbness~Looks better~Less bruising~Less swelling~Less pain~Less itching~Less tingling~Less feeling of pins and needles~Other ________________ (Free Text)"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Participants|||Number
2732702|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14|"Participants responded to the following question during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
2732703|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7|"Participants responded to the following question during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?"|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
2732704|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3|"Participants responded to the following question during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?"|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
2732705|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1|"Participants responded to the following question during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?"|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
2732707|NCT00999141|Secondary|Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14|Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).|Day 0 (preoperative) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Handle number(s)||95% Confidence Interval|Mean
2732708|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732709|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732710|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732711|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732712|NCT00999141|Secondary|Number of Participants With Hematoma/Seroma Anytime During the Study||Day 0 (day of surgery) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732713|NCT00999141|Secondary|Participants With Hematoma/Seroma by Study Day|Investigators assessed each side of the face for the presence of hematoma and/or seroma|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732714|NCT00999141|Secondary|Participants' First Occurrence of Hematoma or Seroma by Study Day|Investigators assessed each side of the face for the presence of hematomas and/or seromas|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
2732715|NCT00999141|Primary|Total Volume of Drainage on Each Side of the Face|Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).|24 hours (± 4h) after surgery|Full Analysis Data Set = All randomized and treated participants|||mL||Full Range|Median
2732716|NCT00999102|Primary|Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination.|Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination (in minutes). The Treadmill Test was Performed at the 4-week Visit of Each Drug/Dose Combination.|After 4 weeks of treatment on each drug/dose combination|All participants who received both interventions and completed all study visits were included in the efficacy analysis.|||minutes||Standard Deviation|Mean
2732717|NCT00999102|Primary|Multidimensional Assessment of Fatigue (MAF) Questionnaire: Global Fatigue Score After 4 Weeks of Treatment on Each Drug/Dose Combination.|"A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living.~Range: 1 (no fatigue) to 50 (extreme fatigue)."|After 4 weeks of treatment on each drug/dose combination|All participants who received both interventions and completed all study visits were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2732718|NCT00999037|Secondary|Serum Phosphate Concentration|Change in serum phosphate at 12 weeks from baseline|12 weeks||||percent change from baseline||Standard Deviation|Mean
2732719|NCT00999037|Secondary|1,25(OH)2vitamin D Value|Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.|12 week||||percent change from baseline||Standard Deviation|Mean
2732720|NCT00999037|Primary|Change in FGF-23 Level|Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.|12 weeks||||percentage change from baseline||Standard Deviation|Mean
2732721|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT3 participant treated with 800 mg grazoprevir, who discontinued, and all GT1 participants were excluded from analysis.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2732722|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT1 participant treated with 50 mg grazoprevir, who discontinued, and all GT3 participants treated with grazoprevir were excluded from analysis.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2732723|NCT00998985|Secondary|24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.|Day 7 at 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.|||nM||90% Confidence Interval|Geometric Mean
2732724|NCT00998985|Secondary|Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.|Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.|||uM.hr||90% Confidence Interval|Geometric Mean
2732725|NCT00998985|Primary|Number of Participants With Clinical and Laboratory Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)|All participants who received at least one dose of the investigational drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment were combined for the summary into a single GT1 and GT3 arm.|||Participants|||Number
2732726|NCT00998881|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
2732727|NCT00998881|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*h / dL||Standard Error|Least Squares Mean
2732728|NCT00998881|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
2732729|NCT00998881|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||Percent||Standard Error|Least Squares Mean
2732730|NCT00998868|Secondary|Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System|"Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.~MRC scale:~Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement."|within one month after enrollment||||Units on a scale (minimum 0, maximum 5)||Standard Deviation|Mean
2732731|NCT00998868|Secondary|Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination|The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.|within one month after enrollment||||participants|||Number
2732732|NCT00998868|Secondary|Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography|All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment||||participants|||Number
2732733|NCT00998868|Primary|Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography|All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment||||participants|||Number
2732734|NCT00998790|Secondary|To Evaluate Patient Quality of Life|"The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.~The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 0-21."|24 months|113 subjects available at baseline. 90 subjects available at 24 month follow-up.|||Score on a scale||Standard Deviation|Mean
2733198|NCT00996736|Secondary|Hard Contact Lens-corrected Visual Acuity Measured in logMAR|Hard contact lens-corrected visual acuity measured in logMAR (logarithm of the Minimum Angle of Resolution) 3 months after enrollment|3 months after enrollment||||logMAR||95% Confidence Interval|Mean
2732738|NCT00998790|Primary|Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up|1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.|24 months|Baseline to 24 month measurement of 1-hour pad weight test. 113 subject available at baseline, 83 available at 24 month follow-up.|||grams||Standard Deviation|Mean
2732739|NCT00998764|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732740|NCT00998764|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732741|NCT00998764|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732742|NCT00998764|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732743|NCT00998764|Secondary|Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|"The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant's caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is yes and a zero score was assigned if the answer is no. For questions answered as not applicable, no score will be assigned. The DAD total score was calculated as the total number of questions answered as yes divided by the total number of questions answered as yes or no, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline."|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on scale||Standard Error|Least Squares Mean
2732744|NCT00998764|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|"The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant's caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is yes and a zero score was assigned if the answer is no. For questions answered as not applicable, no score will be assigned. The DAD total score was calculated as the total number of questions answered as yes divided by the total number of questions answered as yes or no, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline."|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732745|NCT00998764|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8)remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732746|NCT00998764|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8 remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2732747|NCT00998764|Primary|Number of Participants Reporting a Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|Safety population|||Number of Participants|||Number
2732748|NCT00998738|Secondary|Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy|Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.|First cycle of therapy (up to 21 days)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732749|NCT00998738|Secondary|Severity of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.~The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732750|NCT00998738|Secondary|Incidence of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.~The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732751|NCT00998738|Secondary|Toxicity Profile of CaMg Per CTCAE Active Version||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732752|NCT00998738|Secondary|Average Cumulative Ixabepilone Dose||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732753|NCT00998738|Secondary|Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732754|NCT00998738|Secondary|Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version|Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity. Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.|Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732755|NCT00998738|Secondary|Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732756|NCT00998738|Primary|Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.|During the first 18 weeks of ixabepilone-based therapy|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2732839|NCT00998049|Primary|Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis|"Number of CD34 cells/kg collected on days 1-2.~Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm."|After 2 days of apheresis||||participants|||Number
2732757|NCT00998660|Primary|Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.|Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.|3 months|The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee.|||Event rate per 100 subject-months||95% Confidence Interval|Number
2732758|NCT00998582|Primary|Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease.|Change from baseline to 24 weeks|Large artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in large artery elasticity (mL/mmHg x10) from baseline to week 24|||ml/mmHg x10||Inter-Quartile Range|Median
2732759|NCT00998582|Primary|Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|Change from baseline to 24 weeks|Small artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in small artery elasticity (mL/mmHg x100) from baseline to week 24|||ml/mmHg x100||Inter-Quartile Range|Median
2732760|NCT00998517|Secondary|Rates of Gain in Mid-upper Arm Circumference, and Length|These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks||||mm/d||Standard Deviation|Mean
2732761|NCT00998517|Secondary|Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)|Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.|12 months|Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol.|||participants|||Number
2732762|NCT00998517|Secondary|Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment||2 weeks||||participants|||Number
2732763|NCT00998517|Secondary|Number of Patients With Adverse Outcomes|This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.|12 months||||participants|||Number
2732764|NCT00998517|Secondary|Rate of Weight Gain|This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks||||g/kg/d||Standard Deviation|Mean
2732765|NCT00998517|Primary|Number of Patients With Absence of Bilateral Pedal Pitting Edema||12 weeks or recovery||||participants|||Number
2732766|NCT00998517|Primary|Number of Participants With Nutritional Recovery|"Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.~WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/"|12 weeks or upon completion of recovery||||participants|||Number
2732767|NCT00998426|Primary|Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection|All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).|Pre-dose, immediately following, 60 min and 120 min after injection||||mg/dL||Standard Deviation|Mean
2732768|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales (Self-acceptance Dimension), Compared to Clinical Management"|Self-acceptance dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732769|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales (Purpose in Life Dimension), Compared to Clinical Management"|Purpose in life dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732796|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732770|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales (Positive Relations Dimension), Compared to Clinical Management"|Positive relations dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732771|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales (Personal Growth Dimension), Compared to Clinical Management"|Personal growth dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732772|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales (Environmental Mastery Dimension), Compared to Clinical Management"|Environmental mastery dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732773|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire (Hostility Subscale), Compared to Clinical Management"|"Hostility symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress."|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732774|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire (Somatization Subscale), Compared to Clinical Management"|"Somatic symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress."|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732775|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire (Depression Subscale), Compared to Clinical Management"|"Depressive symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress."|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732776|NCT00998400|Secondary|Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up.|Frequencies of negative cardiac outcomes, such as re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty, cardiac surgery, and cardiac mortality occuring after the first episode of ACS.|30-month follow-up post-treatment||||Participants|||Count of Participants
2732777|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales (Autonomy Dimension), Compared to Clinical Management"|Autonomy dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732797|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732864|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||24 weeks|||||||
2732778|NCT00998400|Primary|"Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire (Anxiety Subscale), Compared to Clinical Management"|"Anxious symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress."|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732779|NCT00998400|Primary|Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management|Paykel's 20-item change version of the Clinical Interview for Depression (CID) allows a comprehensive assessment of affective symptomatology and contains 20 items rated on 7-point scales with specification of each anchor point based on severity, frequency and/or quality of symptoms. It adds a dimensional description of mental suffering to traditional psychiatric nosography (DSM). The total score is obtained by adding each of 20 items and it may range from 20 to 140. The higher the score, the worse the psychological condition.|Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up||||score on a scale||Standard Deviation|Mean
2732780|NCT00998374|Primary|Reactive Hypoglycemia Status|"Postoperative reactive hypoglycemia was defined as either~serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing~serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing"|6 months, 9 months, 12 months post-op||||participants|||Number
2732781|NCT00998374|Secondary|Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing|Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response|6, 9, and 12 months post-op||||participants|||Number
2732782|NCT00998374|Secondary|Insulin Resistance|Measured by levels of post prandial insulin|6, 9, and 12 months post-operatively||||pmol/L||Standard Deviation|Mean
2732783|NCT00998374|Primary|Mean Serum Glucose Levels|Serum glucose levels measured to assess reactive hypoglycemia status|30, 60, and 120 minutes at 6, 9, and 12 months post-operatively||||mg/dl||Standard Deviation|Mean
2732784|NCT00998335|Secondary|Percent Change From Baseline in Vascular Inflammatory Markers|Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM|3 and 6 months||||Percentage of change||Standard Deviation|Mean
2732785|NCT00998335|Secondary|Change in Anthropometric Measure (Body Mass Index [BMI]).|Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||Change from baseline (Kg/m2)||Standard Deviation|Mean
2732786|NCT00998335|Secondary|Advanced Lipid Testing|Change in lipoprotein particle number was determined using NMR.|3 and 6 months||||Change in number of particles (nmol/L)||Standard Deviation|Mean
2732787|NCT00998335|Secondary|Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||mg/dL||Standard Deviation|Mean
2732788|NCT00998335|Secondary|Metabolic Control as Measured by the Fasting Plasma Glucose Concentration||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||mg/dL||Standard Deviation|Mean
2732789|NCT00998335|Secondary|Number of Hypoglycemic Events|Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.|3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||Number of events|||Number
2732790|NCT00998335|Secondary|Change in Anthropometric Measure (Body Weight).|Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||Change from baseline (Kg)||Standard Deviation|Mean
2732791|NCT00998335|Secondary|Plasma Lipid Concentration.|Fasting plasma lipid concentration on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||mg/dL||Standard Deviation|Mean
2732792|NCT00998335|Secondary|Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).|Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||% of intramyocellular triglyceride||Standard Deviation|Mean
2732793|NCT00998335|Secondary|Change in Insulin Secretion|Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 at 3 months and N=28 at 6 months."|||ng/ml||Standard Deviation|Mean
2732794|NCT00998335|Secondary|Metabolic Control as Measured by the A1c||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms."|||percentage of A1c||Standard Deviation|Mean
2732795|NCT00998335|Primary|Hepatic Steatosis|Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).|3 and 6 months|In six patients liver MRS was not possible due to claustrophobia, metal parts, or too large for MRI scanner. N=30 participants in the Insulin detemir x 3 months, N=8 participants in the Insulin Detemir alone and 22 in the Detemir Plus Aspart at 6 months.|||percentage of liver fat||Standard Deviation|Mean
2732865|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||0 weeks|||||||
2732798|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732799|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732800|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732801|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732802|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732803|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732804|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732805|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection|"Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732806|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732807|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732808|NCT00998309|Primary|Number of Unlisted Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||Events|||Number
2732809|NCT00998309|Primary|Number of Participants With Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2732810|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy|Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732835|NCT00998049|Secondary|Time to Reach 6 Million CD34 Cells|Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.|Duration of apheresis (up to 7 days)||||days||95% Confidence Interval|Median
2732811|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)|Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732812|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)|Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732813|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications|Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732814|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)|Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732815|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)|Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732816|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)|Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732817|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity|"Number of participants with responders of azithromycin to determine whether Infection severity, mild infection, moderate infection, or severe infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732818|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection|"Number of participants with responders of azithromycin to determine whether type of infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732819|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age|Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732820|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender|Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732821|NCT00998309|Primary|Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.|The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2732822|NCT00998296|Secondary|Percentage Change in the Tumour Size From Baseline During the Expansion Phase|Percentage change in the tumour size from baseline is expressed as Number of subjects with maximum decrease from baseline in the sum of longest diameters of target lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||participants|||Number
2732823|NCT00998296|Secondary|Stable Disease for at Least 12 Weeks During the Expansion Phase|"SD: Neither sufficient shrinkage to qualify for PR (Partial response) nor sufficient increase to qualify for PD(Progressive disease), taking as references the smallest sum of diameters SoD while on study.~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||percentage of participants|||Number
2732836|NCT00998049|Secondary|Median Number of Days of Apheresis||Duration of apheresis (up to 7 days)||||days||Full Range|Median
2732824|NCT00998296|Secondary|Disease Control (DC) During the Expansion Phase|DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:- CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||percentage of participants|||Number
2732825|NCT00998296|Secondary|Objective Response (OR) During the Expansion Phase|"OR is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be nonpathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:~CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||percentage of participants|||Number
2732826|NCT00998296|Secondary|Trough Plasma Concentration of Afatinib at Steady State|"C(pre,ss) is defined as pre-dose (trough) concentration of afatinib in plasma at steady state immediately before administration of the next dose.~C24,7 corresponds to the plasma concentration at 24 hours on Day 7. C24,13 corresponds to the plasma concentration at 24 hours on Day 13. C24,27 corresponds to the plasma concentration at 24 hours on Day 27."|Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"|||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2732827|NCT00998296|Secondary|Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)|"Cpre,ss,norm (Dose normalized trough plasma concentration of nintedanib at steady state) are presented for the 2 MTD treatment groups (continuous administered nintedanib at 150 mg b.i.d. concomitantly with continuously administered afatinib 30 mg q.d. or with intermittently administered afatinib 40 mg q.d.)~As nintedanib is given twice daily, samples are taken at Day 8, Day 15, Day 22 and Day 28; the Pharmacokinetic (PK) parameter names will be Cpre,ss,15,norm (Day 8), Cpre,ss,29,norm (Day 15), Cpre,ss,43,norm (Day 22) and Cpre,ss,55,norm (Day 28)"|Day 8, Day 15, Day 22 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"|||nanogram/millilitre/milligram (ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
2732828|NCT00998296|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|First treatment administration until cut-off date of 02 October 2014, up to 336 days|TS|||participants|||Number
2732829|NCT00998296|Secondary|Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First treatment administration until cut-off date of 02Oct2014; up to 336 days|TS|||participants|||Number
2732830|NCT00998296|Secondary|Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|"The investigator evaluated whether complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) occurred in a patient.~CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions"|6 weeks|TS|||percentage of participants|||Number
2732831|NCT00998296|Primary|Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities|Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.|first treatment cycle, up to 28 days|TS|||percentage of participants|||Number
2732832|NCT00998205|Secondary|Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E')|Echocardiography was performed at rest and with dobutamine stress at 3 minutes, 6 minutes, 9 minutes, and 12 minutes, to measure differences in E/E' at the septum and lateral mitral annulus. Change from baseline at recovery reported.|Baseline, recovery||||Ratio||Full Range|Mean
2732833|NCT00998205|Primary|Change in Left Ventricle Mean Diastolic Pressure|Left ventricle filling pressures were measured using a pigtail catheter inserted into the left ventricle. Measurements of left ventricle pressures were taken at baseline, 3 minutes, 6 minutes, 9 minutes, 12 minutes, and recovery. Change from baseline at recovery reported.|Baseline, recovery||||mmHg||Full Range|Mean
2732834|NCT00998049|Secondary|Rate of Failure to Mobilize|The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.|Duration of apheresis (up to 7 days)||||percentage of participants||95% Confidence Interval|Number
2732840|NCT00998023|Secondary|Major Complications|Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention|1 Day|Per protocol|||Participants|||Number
2732841|NCT00998023|Primary|Mean Score on the Visual Analogue Scale|The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).|Immediately before vascular closure and immediately after vascular closure.|Per protocol|||Scores on a Scale||Standard Error|Mean
2732842|NCT00997984|Secondary|Change From Baseline in Weight at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||pounds||Standard Deviation|Mean
2732843|NCT00997984|Secondary|Change From Baseline in Height at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||inches||Standard Deviation|Mean
2732844|NCT00997984|Secondary|Change From Baseline in Oral Temperature at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||º F||Standard Deviation|Mean
2732845|NCT00997984|Secondary|Change From Baseline in Pulse Rate at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||beats per minute||Standard Deviation|Mean
2732846|NCT00997984|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||mmHg||Standard Deviation|Mean
2732847|NCT00997984|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||mmHg||Standard Deviation|Mean
2732848|NCT00997984|Secondary|Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2732849|NCT00997984|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 8 weeks|FAS|||Percent of Participants|||Number
2732850|NCT00997984|Secondary|Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF|The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2732851|NCT00997984|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2732852|NCT00997984|Secondary|Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2732853|NCT00997984|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and up to 8 weeks|Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.|||Units on a scale||Standard Error|Least Squares Mean
2732854|NCT00997984|Secondary|Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS|||Percent of Participants|||Number
2732855|NCT00997984|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and up to 8 weeks|FAS|||Percent of Participants|||Number
2732856|NCT00997984|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.|||Units on a scale||Standard Error|Least Squares Mean
2732857|NCT00997932|Primary|IUD Expulsion|Expulsion of the LNG-IUS|From time of insertion to final study date which is 6 months after IUD insertion.||||Participants|||Count of Participants
2732858|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||48 weeks|||||||
2732859|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||24 weeks|||||||
2732860|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||48 weeks|||||||
2732861|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||24 weeks|||||||
2732862|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||48 weeks|||||||
2732863|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||48 weeks|||||||
2732870|NCT00997620|Secondary|Nasal Symptom Scores|Total nasal symptom score was measured AM and PM. The reflective scale measures subjective symptoms over the previous 12 hours. Instantaneous symptoms measure how subjects felt at the present time. The score consists of subjective perception of nasal congestion, rhinorrhea, nasal itching and sneezing. The scale for each symptom is 0 - not present, 1- mild (present but minimal), 2 - moderate (symptoms are bothersome but tolerable), 3 - severe (symptoms are not tolerable). The baseline value was the mean of the 7 day placebo run-in for the combined scores. This was calculated for the placebo group and the fluticasone group for both the instantaneous and the reflective scores. The intervention time utilized the same combined AM and PM reflective and instantaneous scoring. The data was analyzed using two sample t test comparison of the placebo vs fluticasone furoate group. Low value, less symptoms. High value, more symptoms. Minimum score is 0. Maximum score is 24.|2 weeks||||units on a scale||Standard Deviation|Mean
2732871|NCT00997620|Secondary|Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire|In nocturnal rhinoconjunctivitis quality of life questionnaire instrument to measure the effects of nasal disorder on nighttime sleep and awakening. It consists of 16 questions. The scale is from 0-6, 0 being not troubled and 6 reflecting extreme trouble. This survey is interpreted as a minimal clinically important difference of each question. A change of +/- 0.5 is a threshold of minimally important clinical difference. Higher value mean more disturbance.|2 weeks|The NRQLQ values represent the average for each intervention.|||units on a scale||Standard Error|Mean
2732872|NCT00997620|Secondary|Change in Epworth Sleep Scale|The Epworth sleepiness scale measures is a validated test of daytime sleepiness which involved the subjects answering 8 questions. Each question is answered on a 0 - 3 scale with 3 being the most likely associated with drowsiness. The score is reported as a composite score of 8 questions, with a minimum score of 0 and a maximum score of 24. A higher composite score represents more likelihood of daytime sleepiness. It is administered between 1500 and 1700 daily.|Baseline and after 2 weeks intervention||||units on a scale||Standard Deviation|Mean
2732873|NCT00997620|Primary|Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.|The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.|over 2 weeks||||milliseconds||Standard Deviation|Mean
2732874|NCT00997620|Primary|Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.|The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.|after 2 weeks intervention||||non identified targets||Standard Deviation|Mean
2732875|NCT00997620|Primary|Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance|The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.|over 2 weeks||||number of errors||Standard Deviation|Mean
2732876|NCT00997594|Primary|Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation|Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.|1 week||||participants|||Number
2732877|NCT00997594|Primary|Serum Cathecholamine Levels||around one year||2015-10-31|10/2015||||
2732878|NCT00997594|Secondary|Increase in Cortisol||1 day|||||||
2732879|NCT00997594|Primary|Increase in Catecholamine||One day|||||||
2732880|NCT00997555|Secondary|Length of Hospital Stay|Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).|until discharge from hospital, data reviewed every 6 months||||days||95% Confidence Interval|Median
2732881|NCT00997555|Secondary|Length of ICU Stay|Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).|until discharge from hospital, data reviewed every 6 months||||days||95% Confidence Interval|Median
2732882|NCT00997555|Secondary|Length of Mechanical Ventilation|Days of mechanical ventilation (bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|until discharge from hospital, data reviewed every 6 months||||days||95% Confidence Interval|Median
2732883|NCT00997555|Secondary|Incidence of Pneumonia|Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)|until discharge from the hospital, data reviewed every 6 months||||participants|||Number
2732884|NCT00997555|Primary|Respiratory Associated Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months||||participants|||Number
2732885|NCT00997555|Primary|All Cause Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months||||participants|||Number
2732886|NCT00997516|Secondary|Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months.|"The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.~Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)"|6 months|Participants who returned surveys for long-term follow-up|||units on a scale||Standard Deviation|Mean
2732904|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2740730|NCT00946088|Primary|Reduction in Delivery Rate Prior to 37 Weeks Gestation|Reduction in delivery rate prior to 37 weeks gestation (preterm birth).|Up to 37 weeks of gestation||||Participants|||Count of Participants
2732887|NCT00997516|Secondary|Body Image Score at 6 Months|"After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.~Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?"|6 months|67 of 75 patients completed and returned follow-up surveys|||units on a scale||Standard Deviation|Mean
2732888|NCT00997516|Secondary|Readmission Within 30 Days.|Number of participants readmitted to the hospital within 30 days of surgery|30 days||||participants|||Number
2732889|NCT00997516|Secondary|Time to Return to Work|Number of calendar days between participants' discharge from the hospital and the first day back at work.|30 days||||Days||Standard Deviation|Mean
2732890|NCT00997516|Secondary|Wound Seroma|Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.|6 months||||participants|||Number
2732891|NCT00997516|Secondary|Deep Space Infection|Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.|6 months||||participants|||Number
2732892|NCT00997516|Secondary|Wound Infection|Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.|6 months||||participants|||Number
2732893|NCT00997516|Secondary|Length of Stay|Number of calendar days the participant was hospitalized.|up to 14 days||||Days||Standard Deviation|Mean
2732894|NCT00997516|Secondary|Visceral or Vascular Injury|Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.|during surgery, up to 6 hours||||participants|||Number
2732895|NCT00997516|Secondary|Procedures Requiring Conversion to Open or Additional Port|Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.|during surgery , up to 6 hours||||participants|||Number
2732896|NCT00997516|Secondary|Operative Time|The amount of time to perform the operation from skin-incision to application of the dressing. This time is routinely charted by the circulating nurse in the operating room.|up to 6 hours||||minutes||Standard Deviation|Mean
2732897|NCT00997516|Primary|Pain After Surgery|Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.|12 hours post-surgery||||units on a scale||Standard Deviation|Mean
2732898|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732899|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732900|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium~Binary Rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732901|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732902|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732903|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2739142|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|1 day prior to drug administration 1||||score on a scale||Standard Error|Mean
2732906|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732907|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732908|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732909|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732910|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732911|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732912|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732913|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732914|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732915|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732916|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732917|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732918|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732919|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732920|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732921|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732922|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732923|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.~Binary Rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2733109|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2732924|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732925|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732926|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732927|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732928|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732929|NCT00997503|Secondary|Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related|MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732930|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732931|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732932|NCT00997503|Secondary|Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population|Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations|12 months|To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis.|||percentage of participants|||Number
2732933|NCT00997503|Secondary|Incremental Rate of Stent Thrombosis (Protocol Definition)|"Stent Thrombosis (protocol definition):~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|1-2 years|To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis.|||percentage of participants|||Number
2732934|NCT00997503|Primary|Cardiac Death or Myocardial Infarction|Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
2732935|NCT00997438|Secondary|RANTES Levels||48 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.|||pg/mL||Standard Error|Mean
2732936|NCT00997438|Secondary|RANTES Levels||24 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.|||pg/mL||Standard Error|Mean
2732937|NCT00997438|Primary|cAMP Levels||4 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients|||pmol cAMP/mg protein||Inter-Quartile Range|Median
2732938|NCT00997438|Primary|cAMP Levels||2 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients|||pmol cAMP/mg protein||Inter-Quartile Range|Median
2732939|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|48 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
2732945|NCT00997425|Primary|Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)|Door and floor cover interventions were compared for efficacy in reducing wandering behavior defined as patient approaching or passing through the equipped exit door. Counts of each behavior were collected on each patient for each intervention period. Mean values of counts were compared.|eight weeks|per protocol|||behavior counts||Standard Error|Mean
2732946|NCT00997386|Secondary|Number of Participants With Overall Survival.|To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.|Day +100|Data were collected but could not be analyzed. PI for this study has retired and any data that were gathered, are lost. No data are available for this assessment||||||
2732947|NCT00997386|Secondary|Number of Participants With Event-free Survival.|To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.|Day +100|Data were collected but could not be analyzed. PI for this study has retired and any data that were gathered, are lost. No data are available for this assessment||||||
2732948|NCT00997386|Secondary|Number of Participants With Relapse-free Survival.|To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.|Day +100|Data were collected but could not be analyzed. PI for this study has retired and any data that were gathered, are lost. No data are available for this assessment.||||||
2732949|NCT00997386|Primary|Number of Participants With Presence of Donor Lymphohematopoietic Chimerism (Defined as at Least 50% Donor Cells in the Peripheral Blood) in Peripheral Blood by Day +100 (i.e., 100 Days After Allogeneic PBSCT).|To determine the efficacy of related or unrelated allogeneic PBSC transplantation (PBSCT) using a preparative regimen of busulfan, melphalan and alemtuzumab, as measured by durable donor lymphohematopoietic cell engraftment. The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).|Day +100|Data were collected but could not be analyzed. PI for this study has retired and any data that were gathered, are lost. No data are available for this assessment||||||
2732950|NCT00997373|Primary|Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer|Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue|At time of consent and after hysterectomy (generally about 3 weeks)|"Subjects completing treatment who had confirmed histopathology compared to a non-randomized group of untreated control subjects. Aromatase inhibitor responsiveness was defined as a proportionate decline in %Ki67 staining of at least 70% between pre-treatment biopsy and hysterectomy 9or repeat biopsy)."|||percentage of Ki67 staining cells||Full Range|Mean
2732951|NCT00997334|Post-Hoc|Feasibility Rate|Feasibility in this study is defined as the percentage of patients who completed a repeated biopsy per protocol after evidence of disease progression.|Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.|The analysis dataset is comprised of all patients eligible for repeat biopsy.|||percentage of participants||90% Confidence Interval|Number
2732952|NCT00997334|Post-Hoc|Time to Repeat Biopsy|Time to repeat biopsy is the duration of time from clinical determination of progressive disease to time of repeat biopsy.|At time of removal from study, patients were asked to undergo a repeat biopsy of their progressing or new tumor lesion. Progression follow up was up to 3 years in this study cohort.|The analysis dataset is comprised of all evaluable patients.|||days||Full Range|Median
2732953|NCT00997334|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2732954|NCT00997334|Primary|Resistance Mechanism|Participants were classified into 4 potential resistant mechanism groups (4 genetic/ 1 histologic) based on evaluation of rebiopsy tissue: EGFR mutations (T790M mutation, exon 20 insertion), KRAS mutations, MET amplification or small-cell lung cancer (SCLC) transform using established methods.|Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort.|The analysis dataset is comprised of all evaluable patients.|||participants|||Number
2732955|NCT00997321|Secondary|Depth of Sedation|Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain|single measurement during sedation procedure|100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation|||score on a scale||Full Range|Median
2732956|NCT00997321|Secondary|Patient Reported Pain or Recall of the Procedure|"patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question"|single measurement immediately after patient returns to baseline mental status after sedation procedure|100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group|||percentage of participants||95% Confidence Interval|Number
2732957|NCT00997321|Secondary|Time to Return of Baseline Mental Status|time in seconds from the first dose of medication until the patient has regained baseline mental status|from start of procedure until the return of baseline mental status up to 120 minutes|50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group|||minutes||95% Confidence Interval|Median
2732958|NCT00997321|Primary|Respiratory Depression (Sub-clinical and Clinical Signs)|binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform|From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)|50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm|||percentage of participants||95% Confidence Interval|Number
2732959|NCT00997243|Secondary|Explore the Biologic Role of microRNAs in Determining Clinical Response to the AZA Plus Lintuzumab Combination and Achievement of the Other Pharmacodynamic Endpoints||Up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
2732960|NCT00997243|Secondary|Perform Exploratory Studies of AZA-triphosphate With Global DNA Methylation||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
2732961|NCT00997243|Secondary|Provide Preliminary Data on the Biological Activity of AZA as a Demethylating Agent (Changes in Target Gene Methylation and Gene Expression, DNMT1[Deoxyribonucleic Acid Methyltransferase 1 DNA Methyltransferase 1]Protein Expression, Global Methylation)||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
2732962|NCT00997243|Secondary|Determine the Relationship Between Pretreatment Expression of Syk and Clinical Response; to Determine Whether the Investigational Agents Modulate Syk Expression and Correlate Drug-induced Changes in Syk With Response to Treatment||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
2732963|NCT00997243|Secondary|Toxicities of the Combination|All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.|up to 5 years||||percentage of participants|||Number
2732964|NCT00997243|Secondary|Overall Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years||||percentage of participants|||Number
2732965|NCT00997243|Primary|Complete Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years||||percentage of participants|||Number
2732966|NCT00997204|Secondary|Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort|"Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed."|48 hours post-dose||||Hours||Inter-Quartile Range|Median
2732967|NCT00997204|Primary|Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant|"Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed.~The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale."|7 days from the beginning of each phase||||participants|||Number
2732968|NCT00997139|Primary|MRSA Clearance Rate|Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.|14 days||||percentage of subjects|||Number
2732969|NCT00997139|Primary|MSSA Clearance Rate|Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.|14 days||||percentage of subjects|||Number
2732970|NCT00997139|Primary|Carrier Rate for Staphylococcus Aureus|Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)|Baseline||||percentage of subjects|||Number
2732971|NCT00997126|Secondary|Patient Reported Recall of the Procedure||Single measurement immediately after patient returns to baseline mental status after sedation procedure||||participants|||Number
2732972|NCT00997126|Secondary|Patient Reported Pain||Single measurement immediately after patient returns to baseline mental status after sedation procedure||||participants|||Number
2732973|NCT00997126|Secondary|Depth of Sedation Measured Using the OAAS Scale|Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli|Single measurement during sedation procedure||||units on a scale||Inter-Quartile Range|Median
2732974|NCT00997126|Secondary|Time to Return of Baseline Mental Status From Start of Procedure in Minutes||Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours||||minutes||Inter-Quartile Range|Median
2732975|NCT00997126|Primary|Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure||From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)||||participants|||Number
2732976|NCT00997113|Secondary|Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure|Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.|single time point measured after sedation procedure completed||||participants|||Number
2732977|NCT00997113|Secondary|Respiratory Depression|categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.|From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status||||participants|||Number
2732978|NCT00997113|Primary|Change in Serum Catecholamines|change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.|one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes||||mcg/ml||Inter-Quartile Range|Median
2732979|NCT00997035|Secondary|Minimum Inhibitory Concentration of Isolates - Voriconazole|Minimum Inhibitory Concentration (MIC) of isolates to voriconazole by treatment arm|7 days||||mg/L||Inter-Quartile Range|Median
2732980|NCT00997035|Secondary|Minimum Inhibitory Concentration of Isolates - Natamycin|Minimum Inhibitory Concentration (MIC) of isolates to natamycin by treatment arm|7 days||||mg/L||Inter-Quartile Range|Median
2732981|NCT00997035|Secondary|Number of Adverse Events|Comparing the number of serious and non-serious adverse events by treatment arm.|3-months from enrollment||||adverse events|||Number
2732982|NCT00997035|Secondary|Microbiological Cure at 7 Days|Fungal Culture negative at 7 days post treatment|7 days|Fungal Culture negative at 7 days post treatment|||Participants|||Count of Participants
2732983|NCT00997035|Secondary|Hazard Ratio for Re-epithelialization|Hazard Ratio of re-epithelialization comparing the treatment groups|Up to 21 days||||Number re-epthelialized/person-days|||Number
2732984|NCT00997035|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks after enrollment|Mean infiltrate scar size at three weeks.|||mm^2||Standard Error|Mean
2732985|NCT00997035|Secondary|Size of Infiltrate/Scar - 3 Months|Size of infiltrate/scar at 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 months after enrollment|Mean infiltrate scar size at three months correcting for baseline scar size and site|||mm^2||Standard Error|Mean
2732986|NCT00997035|Secondary|Best Spectacle-corrected logMAR Visual Acuity at 3-weeks|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear|3 weeks after enrollment|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and study site.|||logMAR||Standard Error|Mean
2732987|NCT00997035|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR visual acuity at 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear|3 months after enrollment|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and study site|||logMAR||Standard Error|Mean
2732988|NCT00997035|Primary|Incidence of Perforation or Therapeutic Penetrating Keratoplasty|Hazard ratio of perforation or therapeutic penetrating keratoplasty (TPK) comparing voriconazole to placebo|3 months from enrollment|Comparison of rate of perforation or TPK between the treatment groups (topical voriconazole with oral voriconazole vs. topical voriconazole with oral placebo)|||New perforations or TPK/person-days|||Number
2732989|NCT00996996|Secondary|Number of Participants Who Received Thyroid Medication After Treatment|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population|||participants|||Number
2732990|NCT00996996|Secondary|Number of Participants With Low or Normal Baseline TSH Levels That Developed Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal Baseline TSH levels were assessed.|||participants|||Number
2732991|NCT00996996|Secondary|Number of Participants With the Adverse Event (AEs) of Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication. An AE is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered to be related to the medical treatment or procedure, that occurs during the course of the study.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population|||participants|||Number
2732992|NCT00996996|Secondary|Time to Elevated TSH Post Baseline for Participants Who Had Low or Normal TSH Levels at Baseline and Elevated Levels Post Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were categorized to have elevated or normal/low TSH values per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal TSH levels at Baseline and elevated levels post Baseline were assessed.|||months||Full Range|Median
2732993|NCT00996996|Secondary|Participants With Elevated TSH Levels at Baseline With Post Baseline TSH Levels of Low/Normal and Elevated|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants with elevated TSH levels at Baseline were assessed.|||participants|||Number
2740731|NCT00946023|Secondary|Graft Failure|Percentage of participants who failed to engraft.|Day 60|Two participants were not analyzed because they died prior to Day 60.|||Participants|||Count of Participants
2732994|NCT00996996|Secondary|Number of Participants With Elevated, Low, and Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline|ITT-Exposed Population. Only those participants for whom TSH levels were recorded at Baseline were assessed.|||participants|||Number
2732995|NCT00996996|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who converted from being negative for HAMA at Baseline to being positive for HAMA any time following treatment were assessed.|||days||Standard Deviation|Mean
2732996|NCT00996996|Secondary|Number of Participants With Conversion to HAMA Positivity Any Time During the Study From Baseline|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who were evaluable for HAMA were assessed.|||participants|||Number
2732997|NCT00996996|Secondary|Number of Participants Evaluable and Not Evaluable for Human Anti-Murine Antibodies (HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population|||participants|||Number
2732998|NCT00996996|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE)|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. A fatal SAE is a medical event that results in death.|From Baseline up to 12 years from the start of treatment (long-term follow up)|ITT-Exposed Population|||participants|||Number
2732999|NCT00996996|Secondary|Normal Organ Dosimetry for the Indicated Organs|Organ dosimetry was performed in participants using the kidneys, liver, lungs, spleen, red marrow, urinary bladder, and the remainder of the body as source organs. Organ doses and Iodine I-131 Anti-B1 Antibody biodistribution were comparable across the three Anti-B1 Antibody manufacturers. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). For the spleen (corrected) category, participant-specific corrections were made to account for individual spleen size.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants who had available gamma camera images for the indicated organs were assessed.|||cGy/75 cGy total body dose (TBD)||Standard Deviation|Mean
2733000|NCT00996996|Secondary|Total Body Effective Half-life (EHL)|Total body EHL is the time required for a radioactive element in the body to be diminished by 50% as a result of radioactive decay and biologic elimination. The EHL is equal to the product of the biologic half-life (BHL) and the radioactive half-life (RHL) divided by the sum of the BHL and the RHL: EHL=(BHL * RHL)/(BHL + RHL). BHL is the time it takes for a drug to lose half of its pharmacologic, physiologic, or radiologic activity. RHL is the time taken for half of the radioactive nuclei to decay.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population|||hours||Standard Deviation|Mean
2733001|NCT00996996|Secondary|Volume of Distribution at Infusion Time 0 (Vd0) and Steady State (Vdss)|Volume of distribution at the start of infusion and at steady state of I-131 tositumomab. The volume of distribution measures how much the drug spreads through the body after the dose. Steady state is defined as that state at which the overall intake of a drug is fairly in dynamic equilibrium with its elimination.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||milliliters (ml)||Standard Deviation|Mean
2733002|NCT00996996|Secondary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed I-131 tositumomab concentration from time zero (end of the dosimetric dose infusion) to 120 hours after the end of the infusion. Unit: %ID/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. Cmax is the highest drug concentration in the blood after infusion.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||%ID/ml||Standard Deviation|Mean
2733003|NCT00996996|Secondary|Clearance Values|Clearance of I-131 tositumomab after intravenous administration was measured. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||Milliliters per hour (ml/hr)||Standard Deviation|Mean
2739143|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|2-4 weeks prior to drug administration||||score on a scale||Standard Error|Mean
2733004|NCT00996996|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours and 0 to Infinity Hours|Area under the concentration-time curve for I-131 tositumomab from time 0 to 120 hours and time 0 to infinity hours (extrapolated) after the end of the dosimetric dose infusion was measured. Unit: %ID*h/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours and 0-infinity hours from the dosimetric dose (given only on Day 0) and 0-120 hours and 0-infinity hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||%ID*h/ml||Standard Deviation|Mean
2733005|NCT00996996|Secondary|Terminal Half-life (t1/2beta)|t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||hours||Standard Deviation|Mean
2733006|NCT00996996|Secondary|Initial Half-life (t1/2alpha)|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||hours||Standard Deviation|Mean
2733007|NCT00996996|Secondary|Progression-free Survival (PFS) Based on Participants' Baseline PCR Status|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent. PFS is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR status taken at Baseline were evaluated for PFS.|||months||95% Confidence Interval|Median
2733008|NCT00996996|Secondary|Duration of Response (the Time From the First Documented Response to the First Documented Progression) for Participants Who Were PCR Positive at Baseline and Converted to PCR Negative Status After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who were PCR positive at Baseline and converted to a status of PCR negative were assessed.|||months||95% Confidence Interval|Median
2733009|NCT00996996|Secondary|Number of Participants Who Were Polymerase Chain Reaction (PCR)-Positive at Baseline With Bone Marrow Conversion to a Status of PCR Positive and Negative Any Time After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR-positive status at Baseline were assessed. One participant had a Baseline measurement but no post Baseline measure, and was thus not assessed.|||participants|||Number
2733010|NCT00996996|Secondary|Number of Participants With Resolution of All Baseline B-symptoms by the End of the Study|"The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (called B-symptoms) are present, a B classification is added to the stage: night sweats, intermittant fever, and weight loss. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas."|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced any B-symptom at Baseline were assessed. Not all participants experienced all B-symptoms at Baseline; thus, the number of participants analyzed represents all participants who experienced at least one B-symptom.|||participants|||Number
2733011|NCT00996996|Secondary|Time to Progression of Disease or Death (Progression-free Survival)|Time to progression is defined as the time from the treatment start date to the first documented progression or death. Progressive Disease is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced disease progression or died were assessed.|||months||95% Confidence Interval|Median
2733012|NCT00996996|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who died during the study due to any cause were assessed.|||months||95% Confidence Interval|Median
2733013|NCT00996996|Secondary|The Estimated Value Represents the Percentage of Participants With a PR|Duration of response (CR, CCR, or PR) is defined as the time from the first documented response to the first documented progression. Progressive Disease (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants who experienced confirmed CR, CCR, or PR with PD were assessed. Response (R) had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented.|||months||95% Confidence Interval|Median
2733014|NCT00996996|Primary|Number of Participants With Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population|||participants|||Number
2733015|NCT00996996|Primary|Number of Participants With Confirmed Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|Responses were confirmed by two separate response evaluations at least 4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants evaluable for confirmed response (R) were assessed. R had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented in the table.|||participants|||Number
2733016|NCT00996996|Primary|Number of Participants With Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), or Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population|||participants|||Number
2733017|NCT00996996|Primary|Number of Participants With Confirmed Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|Confirmed response required CR, CCR, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population: all participants who were enrolled in the study and received at least one dose of study drug. Only participants evaluable for confirmed response were assessed.|||participants|||Number
2733018|NCT00996944|Secondary|Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period)|For on-dialysis analysis, measurements were to have been taken 1 hour before dialysis, in the artery/vein at the beginning, during, and end of dialysis, and 1 hour after dialysis. For off-dialysis analysis, measurements were to have been taken 1 hour before dialysis, at the beginning, during, and end of dialysis, and 1 hour after dialysis.|Week 12 through Week 64|PK analysis was not performed because there were no participants (who had received a maintenance dose of the IP for more than 1 week in the long-term treatment period) from whom a blood sample could be collected when decision of study termination was made.||||||
2733019|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|LONG WD (up to Week 64)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the and LONG WD data.|||hours||Standard Deviation|Mean
2733020|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|DBT WD (up to Week 12)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the DBT WD data.|||hours||Standard Deviation|Mean
2733021|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|Week 0 and Week 12|FAS. Participants without symptoms were not included in the analysis of Week 0 data. Participants without symptoms and participants prematurely withdrawn from the study were not included in the analysis of Week 12 data.|||hours||Standard Deviation|Mean
2733022|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.|||participants|||Number
2733023|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||participants|||Number
2739144|NCT00957333|Secondary|Urinary Bladder Capacity||1 day|||||||
2733024|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||participants|||Number
2733025|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2733026|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2733027|NCT00996944|Secondary|The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2733028|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2733029|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2733030|NCT00996944|Primary|IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12, and 2 participants had missing DBT WD data.|DBT WD (up to Week 12)|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.|||units on a scale||Standard Deviation|Mean
2733031|NCT00996944|Secondary|Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2733032|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||participants|||Number
2733033|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.|||participants|||Number
2733034|NCT00996944|Secondary|Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||participants|||Number
2733035|NCT00996944|Secondary|IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS.|LONG WD (up to Week 64)|FAS. One participant in each group had no measurement data and thus was not included in the analysis. These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.|||units on a scale||Standard Deviation|Mean
2733036|NCT00996944|Primary|International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.|Week 0 and Week 12|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.|||units on a scale||Standard Deviation|Mean
2733037|NCT00996931|Secondary|Change in Childhood Autism Rating Scale (CARS)Value From Baseline to 6 Weeks|Change in CARS value from baseline to 6 weeks. Total CARS scores range from a fifteen to 60, with a minimum score of thirty serving as the cutoff for a diagnosis of autism on the mild end of the autism spectrum.|Baseline and 6 weeks|Intention to treat|||mean change in units on scale||Standard Deviation|Mean
2733038|NCT00996931|Primary|Change in TNF-alpha Levels|Change in CSF-TNF-α from baseline to 12 weeks.|Baseline and 12 weeks|Intention to treat|||mean % change||Standard Deviation|Mean
2733039|NCT00996918|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state|Weeks 6, 19, 32, 45 and 78||||Units on a scale||Standard Error|Least Squares Mean
2733040|NCT00996918|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Weeks 6, 19, 32, 45 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733041|NCT00996918|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733042|NCT00996918|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733059|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733043|NCT00996918|Secondary|Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78|The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733044|NCT00996918|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733045|NCT00996918|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733046|NCT00996918|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
2733047|NCT00996918|Primary|Number of Participants Reporting a Serious Adverse Event.|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|The Safety Population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).|||Number of participants|||Number
2733048|NCT00996892|Secondary|Progression-Free Survival (PFS) - Dose Escalation Stages 1, 1A and 1B|PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.||||||
2733071|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733049|NCT00996892|Secondary|Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B|Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.||||||
2733050|NCT00996892|Secondary|Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B|Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
2733051|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733052|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733053|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733054|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733055|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733056|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733057|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733058|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733106|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733060|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733061|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733062|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733063|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733064|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733065|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733066|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733067|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733068|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733069|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733070|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733107|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733072|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733073|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733074|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733075|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733076|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733077|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733078|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733079|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733080|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733081|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733082|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733083|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733084|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2 All Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733085|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733086|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733087|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733088|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733089|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733090|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733091|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733092|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733093|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733094|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733095|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733096|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733097|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733098|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733099|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733100|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733101|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733102|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733103|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733104|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733105|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733110|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733111|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733112|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733113|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733114|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733115|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733116|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733117|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733118|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733119|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733120|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733121|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733122|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2733123|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733124|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733125|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733126|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733127|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733128|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733129|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733130|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2733131|NCT00996892|Secondary|Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2733132|NCT00996892|Secondary|Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
2733133|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733134|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733135|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733136|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733137|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733138|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733139|NCT00996892|Primary|AUC0-24 of Pictilisib on Day 1 - Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733140|NCT00996892|Primary|Cmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733141|NCT00996892|Primary|Tmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3||0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733142|NCT00996892|Primary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nonograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2733143|NCT00996892|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2733144|NCT00996892|Primary|Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3||0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4|Pharmacokinetic (PK) population included all participants who had at least one cobimetinib and pictilisib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2733145|NCT00996892|Primary|Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B|MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants evaluable for specified categories.|||mg|||Number
2733146|NCT00996892|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B|DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population included all participants who received at least one dose of study drug. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
2733147|NCT00996840|Secondary|Maximum Observed Concentration (Cmax) of SB-681323|Absolute values of the Cmax of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3)|PK population. Only those participants available at the specified time points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2733148|NCT00996840|Secondary|Mean Average Concentration (Cavg) of SB-681323|Absolute values of mean Cavg of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10minutes [min], 24h 45min, 27, 34, 40, 80 h since doing on Day 3)|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2733149|NCT00996840|Secondary|Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)|Absolute values of the mean AUC 0-24 of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h10minutes [min], 24h45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose)|Pharmacokinetic (PK) population was defined as patients in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Note: Due to some placebo patients PK samples being assayed in error, the above PK population definition was adjusted to also exclude any patient receiving Placebo.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2733150|NCT00996840|Secondary|Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of MPO levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||pg/mL||95% Confidence Interval|Geometric Mean
2739121|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|6 weeks prior to drug administration 2||||score on a scale||Standard Error|Mean
2733151|NCT00996840|Secondary|Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I|Samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of soluble tumor necrosis factor receptors-I levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||pg/mL||95% Confidence Interval|Geometric Mean
2733152|NCT00996840|Secondary|Mean Serum C-Reactive Protein (CRP) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of serum CRP levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||mg/L||95% Confidence Interval|Geometric Mean
2733153|NCT00996840|Secondary|Mean Serum CXCL8 (Interleuin-8) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum CXCL8 (Interleuin-8) levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||pg/ml||95% Confidence Interval|Geometric Mean
2733154|NCT00996840|Secondary|Mean Serum Interleukin-6 Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum interleukin-6 levels at these specified time oints were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|Pharmacodynamic (PD) Population was defined as patients in the ‘All Subjects’ population for whom a pharmacodynamic sample was obtained and analysed (Flow Cytometry data were excluded from the definition of pharmacodynamic sample). Only those participants available at the specified time points were analyzed.|||Picogram per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2733155|NCT00996840|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Follow-up (Day 7)|All subject population.|||Participants|||Count of Participants
2733156|NCT00996840|Primary|Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals|12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measures RR, PR, QRS, QT, and QTc intervals. Absolute mean values of PR, QRS, QT, and QTcB, QTcF, RR intervals were reported.|Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow-up (Day 7)|All subject population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
2733157|NCT00996840|Primary|Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry|Assessment of mean FiO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h"|All subject population. Data was not collected for this parameter.||||||
2733158|NCT00996840|Primary|Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures|Assessment of mean level of peak and plateau ventilator pressures was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h"|All subject population. Data was not collected for this parameter.||||||
2733159|NCT00996840|Primary|Vital Signs: Mean Level of Positive End Expiratory Pressure|Assessment of level of positive end expiratory pressure was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h"|All subject population. Data was not collected for this parameter.||||||
2733160|NCT00996840|Primary|Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry|Assessment of SaO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h; for Cohort 2 and 4: Day 2, pre-dose, and Day 3, pre-dose and 24 h"|All subject population. Data was not collected for this parameter.||||||
2733161|NCT00996840|Primary|Vital Sign: Mean Percent Oxygen (O2) in Blood|Absolute values of mean percent O2 in blood were reported.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Percent O2||Standard Deviation|Mean
2733162|NCT00996840|Primary|Vital Parameter: Mean Heart Rate|Absolute values of mean heart rate were reported.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2733163|NCT00996840|Primary|Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Absolute values of SBP and DBP were reported.|"For Cohort 1 and 3: Day 1, 4 h, Day 2, pre-dose, Day 3, pre-dose and 24 h and Follow up (Day 7); for Cohort 2 and 4: Day 2, pre-dose, Day 3, pre-dose and 24 h, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Millimeter of Mercury (mmHg)||Standard Deviation|Mean
2733165|NCT00996840|Primary|Mean Clinical Chemistry Parameters-estradiol|Absolute values of Estradiol were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|Day 1 (pre-dose) and Day 3 (24 h)|All subject population. Only those participants available at the specified time points were analyzed. Data were not collected from participants in Cohort 2-SB-681323, 7.5 mg, 24 h, Cohort 3-SB-681323, 7.5 mg, 4 h, and Cohort 4-SB-681323, 10 mg, 24 h.|||Picomole per liter||Standard Deviation|Mean
2733166|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)|Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Millimole per liter||Standard Deviation|Mean
2733167|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Micromol per liter||Standard Deviation|Mean
2733168|NCT00996840|Primary|Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase|Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2733169|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Albumin and Total Protein|Absolute values of albumin and total protein were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2733170|NCT00996840|Primary|Mean Hematology Parameters-reticulocytes, Red Blood Cell Count|Absolute values of reticulocytes and red blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Trillion cells per liter (TI/L)||Standard Deviation|Mean
2733171|NCT00996840|Primary|Hematology Parameters-Mean Corpuscle Volume|Absolute values of mean corpuscle volume were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
2733172|NCT00996840|Primary|Mean Hematology Parameters- Mean Corpuscle Hemoglobin|Hematology parameter mean corpuscle hemoglobin was reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Picogram (pg)||Standard Deviation|Mean
2733173|NCT00996840|Primary|Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)|Mean hematology parameters including hemoglobin, MCHC were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2733174|NCT00996840|Primary|Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count|Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject Population comprised of as all participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Giga cells per liter||Standard Deviation|Mean
2733175|NCT00996801|Primary|Number of Participants With Predefined Tier 1 Adverse Events|Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2733176|NCT00996801|Primary|Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a Tier 1 AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons)."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2733177|NCT00996801|Primary|Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a Tier 1 adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2733178|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Osteocalcin|"Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter~(mL)."|Baseline and Month 12|Analysis of osteocalcin was not conducted when it was determined that the efficacy of MK-5442 was not significantly different than placebo.||||||
2733179|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733180|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)|s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733181|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml).|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733182|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)|"Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine.~uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr"|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733183|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcomes analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733184|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733185|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733186|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine|vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733224|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level|Level of HELIX-II was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733187|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733188|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733189|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733190|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733191|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733192|NCT00996801|Primary|Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)|"Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
2733193|NCT00996775|Primary|Reduction in Percentage of Heavy Drinking Days|"reduction in the percentage of heavy drinking days over the prior 30-days.~a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men)."|baseline to six-month follow-up||||percentage of heavy drinking days||Standard Deviation|Mean
2733194|NCT00996736|Secondary|Microbiological Cure at 6 Days|Microbiological cure defined as no fungal growth on culture at 6 (+/-1) days from enrollment|7 days after enrollment|Of the 323 participants with smear-positive ulcers enrolled in the trial, 299 (92.6%) were scraped and cultured 6 days after enrollment - 155 in the natamycin arm, and 144 in the voriconazole arm.|||participants|||Number
2733195|NCT00996736|Secondary|Minimum Inhibitory Concentration of Isolates|Minimum inhibitory concentration (50th percentile) of fungal isolates to natamycin and voriconazole|3 months after enrollment|The population for analysis included only those subjects with positive fungal cultures and for whom Minimum Inhibitory Concentrations were available (108 subjects who were randomized to natamycin and 113 who were randomized to voriconazole).|||μg/ml||95% Confidence Interval|Mean
2733196|NCT00996736|Secondary|Time to Resolution of Epithelial Defect|Time in days from enrollment to resolution of epithelial defect. For those subjects with more than 21 days to resolution, 21 days was used.|From enrollment to the time of resolution of epithelial defect||||days||Standard Deviation|Mean
2733197|NCT00996736|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks and 3 months after enrollment||||mm||95% Confidence Interval|Mean
2739145|NCT00957333|Primary|Substance Abuse Situation Record|Substance abuse situation record: ketamine|1 day||||years||Full Range|Mean
2733199|NCT00996736|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR (logarithm of the Minimum Angle of Resolution) visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model|3 weeks after enrollment|306 total subjects (155 in natamycin arm, 151 in voriconazole arm) returned after enrollment for a second visit, but only 293 of those (149 in natamycin arm and 144 in voriconazole arm) visited within the 3-week window (2.5-5 weeks). Only those who visited within the window were included in the analysis.|||logMAR||95% Confidence Interval|Mean
2733200|NCT00996736|Primary|Best Spectacle-corrected logMAR Visual Acuity|The primary analysis is best spectacle-corrected logMAR (logarithm of the Minimum Angle or Resolution) visual acuity, correcting for enrollment BSCVA and treatment arm in a multiple linear regression model. The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
2733201|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
2733202|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
2733203|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
2733204|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
2733205|NCT00996658|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication. Three subjects in each arm excluded for site non-compliance.|||Participants|||Number
2733206|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=6.5% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.|||Participants|||Number
2733207|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=7.0% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.|||Participants|||Number
2733208|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2733209|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2733210|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2733211|NCT00996658|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
2733212|NCT00996632|Secondary|Time of Discharge|evaluation about the time of discharge from hospital|days||||Days||Standard Deviation|Mean
2733213|NCT00996632|Primary|Drainage Volume|volume in milliliters of axillary drainage|discharge day|the number of participants for analysis was determined by mean of power sample size calculation|||milliliters||Standard Deviation|Mean
2733225|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level|Level of PIIANP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2740299|NCT00949988|Secondary|To Assess the Safety Profile of D+R in Relapsed/Refractory CLL Patients||2 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2733214|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis|Ntotal and ME were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of NtotalME was expressed as voxels times ratio of signal intensity before and after contrast injection (v*ratio). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||v*ratio||Standard Deviation|Mean
2733215|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis|Ntotal and IRE were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of IRE. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of Ntotal×IRE was expressed as voxels times change in relative intensity per second (v*ΔI/sec). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||v*ΔI/sec||Standard Deviation|Mean
2733216|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis|Nwashout was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nwashout. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||washout enhancing voxels||Standard Deviation|Mean
2733217|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis|Nplateau was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nplateau. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||plateau enhancing voxels||Standard Deviation|Mean
2733218|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis|Npersistent was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Npersistent. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||persistent enhancing voxels||Standard Deviation|Mean
2733219|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis|Ntotal was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||enhancing voxels||Standard Deviation|Mean
2733220|NCT00996606|Secondary|Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis|ME was approximated by parametric mapping via DYNAMIKA software and expressed as ratio of signal enhancement before and after contrast injection. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||ratio||Standard Deviation|Mean
2733221|NCT00996606|Secondary|Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis|IRE was approximated by parametric mapping via DYNAMIKA software and expressed as change in relative signal intensity per second (ΔI/sec). The mean of three different slices was used in the determination of IRE. Each slice consisted of a two-dimensional (2D) sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||ΔI/sec||Standard Deviation|Mean
2733222|NCT00996606|Secondary|Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration|Level of STR was measured in pg/mL. Baseline AV and changes from Baseline to Day 2 and Weeks 2 and 4 were averaged among all participants.|Baseline; Day 2; and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733223|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration|Level of Hb was measured in grams per liter (g/L). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||g/L||Standard Deviation|Mean
2733226|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level|Level of ICTP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733227|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level|Level of CTX-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733228|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level|Level of Type I collagen N-propeptide was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733229|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Osteocalcin Level|Level of osteocalcin was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733230|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level|Level of MCaP-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733231|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-17 Level|Level of IL-17 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733232|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-1β Level|Level of IL-1β was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733233|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level|Level of TNF-α was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733234|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level|Level of APRIL was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733235|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level|Level of BAFF was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733236|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level|Level of SDF1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733237|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level|Level of BCA was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733238|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733239|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733240|NCT00996606|Secondary|Change From Baseline to Week 4 in Plasma B Cell Level|The absolute number of plasma B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
2733241|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells|The intensity of plasma B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
2733242|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs|The intensity of plasma B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733243|NCT00996606|Secondary|Change From Baseline to Week 4 in Transitional B Cell Level|The absolute number of transitional B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
2733244|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells|The intensity of transitional B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
2733245|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs|The intensity of transitional B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733246|NCT00996606|Secondary|Change From Baseline to Week 4 in Memory B Cell Level|The absolute number of memory B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
2733247|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells|The intensity of memory B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
2733248|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs|The intensity of memory B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733249|NCT00996606|Secondary|Change From Baseline to Week 4 in Mature B Cell Level|The absolute number of mature B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
2733250|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells|The intensity of mature B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
2733251|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs|The intensity of mature B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733252|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence|The mean fluorescence intensity of IgM-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733253|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs|The intensity of IgM-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733254|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD38-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733255|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs|The intensity of CD38-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733256|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD27-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733257|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs|The intensity of CD27-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733258|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD24-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733259|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs|The intensity of CD24-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733260|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733261|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs|The intensity of CD19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733262|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cell Level|The absolute number of Th17 cells was expressed as cells/mcL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
2733263|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells|The intensity of Th17 cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of T cells||Standard Deviation|Mean
2733264|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs|The intensity of Th17 cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733385|NCT00996307|Secondary|Antibody Persistence by Geometric Mean Titers (GMT)|Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.|6 months (Day 202) and 12 months (Day 387) after second vaccination|The analysis was done on the subgroup of the per-protocol set (PPS).|||Titer||95% Confidence Interval|Geometric Mean
2733265|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cell Level|The absolute number of Treg cells was expressed as cells per microliter (cells/mcL). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
2733266|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells|The intensity of Treg cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of T cells||Standard Deviation|Mean
2733267|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs|The intensity of Treg cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733268|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence|The mean fluorescence intensity of IL-23Rp19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733269|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs|The intensity of IL-23Rp19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733270|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733271|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs|The intensity of CCR4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733272|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR6-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733273|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs|The intensity of CCR6-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733274|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence|The mean fluorescence intensity of CD45RO-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733275|NCT00996606|Secondary|"Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs"|The intensity of CD45RO-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733276|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD25-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733409|NCT00996203|Secondary|C-Reactive Protein|CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mg/L||Standard Deviation|Mean
2733277|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs|The intensity of CD25-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733278|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
2733279|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs)|The intensity of CD4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
2733280|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level|Level of mRNA for FOXP3 (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
2733281|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level|Level of ROR-γT (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
2733282|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level|Level of mRNA for IL-23 receptor (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
2733283|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level|Level of mRNA for IL-17 (2^ΔCt) was quantified by polymerase chain reaction (PCR). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
2733284|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level|Level of sIL6R was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733285|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration|Level of hsCRP was measured in mg/dL. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||mg/dL||Standard Deviation|Mean
2733286|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR)|ESR was measured in millimeters per hour (mm/h). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||mm/h||Standard Deviation|Mean
2733287|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration|Level of VEGF was measured in picograms per milliliter (pg/mL). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
2733288|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score|The DAS28 was derived from assessments of C-reactive protein (CRP), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] plus (+) [0.28 × square root of SJC] + [0.36 × natural log (CRP + 1)] + [0.014 × VAS] + 0.96. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. CRP was measured in milligrams per deciliter (mg/dL). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
2733289|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assessed 20 items in eight functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score was calculated as an average of all item scores, and thus also ranged from 0 to 3. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an increase in ability to perform activities independently.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
2733290|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score|Global assessment of disease activity was performed using a 0- to 100-mm VAS, where the distance from 0 mm represented the investigator's evaluation or the participant's self evaluation of disease activity (0 mm = no disease activity, 100 mm = maximum disease activity). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||mm||Standard Deviation|Mean
2733291|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score|Perceived pain was assessed on a 0- to 100-millimeter (mm) VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated a decrease in perceived pain.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||mm||Standard Deviation|Mean
2733292|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score|The Ritchie Articular Index was scored on a scale of 0 to 3, according to the grades of tenderness in each of 26 assessed joints. The total score was taken as the sum of joint scores and ranged from 0 to 78. Scores of 0 reflected no tenderness, while higher scores reflected increased tenderness. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in joint tenderness.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
2733293|NCT00996606|Secondary|Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS)|The TMSS was calculated as the sum of ES and JSNS and ranged from 0 to 202. The ES was taken as the sum of joint scores collected for 14 joints in each hand (individually scored from 0 to 7) and ranged from 0 to 98 for both hands. The JSNS was the sum of joint scores collected for 13 joints in each hand (individually scored from 0 to 8) and ranged from 0 to 104 for both hands. Scores of 0 reflected no change, while higher scores reflected increased disease activity. Baseline AV and changes from Baseline to Weeks 24 and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2733294|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 45) and MCP joints (range, 0 to 24). Aggregate wrist and MCP joint scores could range from 0 to 69 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2733295|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. The number of bones with edema was taken as the count of joints with a bone edema score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||bones with bone marrow edema||Standard Deviation|Mean
2733296|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to 10% increase in extent of erosion. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 150) and MCP joints (range, 0 to 80). Aggregate wrist and MCP joint scores could range from 0 to 230 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2773215|NCT00717977|Primary|Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
2733297|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to a 10% increase in extent of erosion. The number of bones with erosion was taken as the count of joints with a bone erosion score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||bones with erosion||Standard Deviation|Mean
2733298|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Synovitis of MCP joints was determined on the basis of Short Inversion Time Inversion Recovery (STIR) sequence evaluation with modification of the RAMRIS score. Four MCP joint compartments were each assessed 0 to 3, so the aggregated MCP joint score ranged from 0 to 12. Combined synovitis in wrist and MCP joints was determined on the basis of STIR sequences to produce overall score from 0 to 21. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2733299|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection|REE per second was calculated as [S55 - S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent rate of early enhancement||Standard Deviation|Mean
2733300|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection|RE was calculated as [S0 - S55] ÷ S0 × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent relative enhancement||Standard Deviation|Mean
2733301|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2733302|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection|REE per second was calculated as [S55 - S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent rate of early enhancement||Standard Deviation|Mean
2733303|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection|RE was calculated as [S0 minus (-) S55] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent relative enhancement||Standard Deviation|Mean
2734105|NCT00990652|Other Pre-specified|Change in MGMT Methylation Status as Well as Other Methylation Patterns in Plasma|To determine MGMT methylation status as well as other methylation patterns in plasma|Blood samples drawn on days 1, 4, and 8 pre-surgery, and then prior to cycle 1 and every 2 cycles thereafter|||||||
2733304|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score|Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2733305|NCT00996593|Primary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
2733306|NCT00996593|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.|||days||Full Range|Median
2733307|NCT00996593|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||participants|||Number
2733308|NCT00996593|Secondary|Nadir Values for Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||cells/microliter||Full Range|Median
2733309|NCT00996593|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||G/dL||Full Range|Median
2733310|NCT00996593|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||cells/millimeters cubed (mm^3)||Full Range|Median
2733311|NCT00996593|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||days||Full Range|Median
2733312|NCT00996593|Secondary|Number of Participants With Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants who experienced any SAE were analyzed.|||participants|||Number
2733313|NCT00996593|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.|||participants|||Number
2733314|NCT00996593|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||participants|||Number
2733315|NCT00996593|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||participants|||Number
2733316|NCT00996593|Primary|Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who experienced progression were evaluated.|||months||95% Confidence Interval|Median
2733317|NCT00996593|Primary|Progression-free Survival for Participants With or Without a Prior Response to Rituximab|Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.|||months||95% Confidence Interval|Median
2733318|NCT00996593|Primary|Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.|||months||95% Confidence Interval|Median
2733319|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.|||participants|||Number
2733320|NCT00996593|Primary|Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.|||months||95% Confidence Interval|Median
2733321|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study|Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.|||participants|||Number
2733322|NCT00996593|Primary|Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator|Response duration is defined as the time from the first documented response until progressive disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2733323|NCT00996593|Primary|Duration of Response for CR and CCR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2733324|NCT00996593|Primary|Duration of Response for Confirmed CR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2733325|NCT00996593|Primary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2733791|NCT00992784|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
2733326|NCT00996593|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.|||participants|||Number
2733327|NCT00996593|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.|||participants|||Number
2733328|NCT00996593|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2733329|NCT00996593|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2733330|NCT00996580|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication|||pregnancies / cumulative exposure||95% Confidence Interval|Number
2733331|NCT00996580|Primary|Summary of Participants With Treatment-emergent Adverse Events|"The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date.~Relationship to study drug was assessed by the investigator.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Day 1 up to 13 months|Safety population of treated participants|||participants|||Number
2733332|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
2733333|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods including condoms were used.|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
2774964|NCT00706823|Secondary|Number of Attempts|The number of attempts taken to place the device|Before intubation||||participants|||Number
2733334|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 28-day cycle.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
2733335|NCT00996580|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.|||pregnancies / cumulative exposure||95% Confidence Interval|Number
2733336|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
2733337|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods including condoms were used.|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
2733338|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
2733339|NCT00996502|Secondary|Proportion of Patients Alive at One Year (Phase II)||One year|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.||||||
2733340|NCT00996502|Secondary|Overall Survival Rate||2 years|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.||||||
2733341|NCT00996502|Secondary|Objective Response Rate at the Recommended Phase II Dose Level of Docetaxel, Bevacizumab, Erlotinib, and Prednisone||Every 9 weeks|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.||||||
2733342|NCT00996502|Primary|Maximum Tolerated Dose of Docetaxel in Combination With Erlotinib, Bevacizumab, and Prednisone (Phase I)||After three 21-day cycles|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.||||||
2734319|NCT00989157|Primary|Cmax|The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||ng/ml||Standard Deviation|Mean
2733343|NCT00996489|Secondary|Mean Number of Sites Injected by Coaptite||Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||number of sites||Standard Deviation|Mean
2733344|NCT00996489|Secondary|Volume of Coaptite Injected Per Treatment||Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||milliliter (mL)||Standard Deviation|Mean
2733345|NCT00996489|Secondary|Incontinence Quality of Life (iQoL) Scores|The iQoL measured the effect of urinary incontinence on QoL. It was divided into 3 subscales: 1 (avoidance and limiting behaviour); 2 (psychosocial impact), and 3 (social embarrassment). The iQOL was comprised of 22 items, each with the response scale from 1 (extremely) to 5 (not at all). A mean score for each subscale was calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores were then transformed to a scale score ranging from 0 to 100 points, where higher scores indicated less impact of incontinence on QoL.|Baseline and Months 6, 12, 18, 24, 30, and 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||units on a scale||Standard Deviation|Mean
2733346|NCT00996489|Secondary|Number of Participants With Urge Incontinence Medication (UIM) Status|The use of urge incontinence medications was collected pre-treatment and post-treatment.|Baseline up to Month 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||participants|||Number
2733347|NCT00996489|Secondary|Number of Participants With Alternative Treatments for Incontinence|Number of participants with alternative treatment such as kegel exercises, sling, sling/cystocele repair, surgery, permanent abdominal tube, intravesical botox, sling/graft, sling removal, estradiol vaginal cream, bladder neck suspension, tension free vaginal tape, biofeedback, polydimethylsiloxane injections, solifenacin orally, bladder specific control physical therapy, for stress urinary incontinence were assessed.|Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36|The SES was the subset of all participants enrolled who were exposed to the study device at least once.|||participants|||Number
2733348|NCT00996489|Secondary|Time to Coaptite Retreatment|Time to additional coaptite treatment or any other alternative treatment for stress urinary incontinence was recorded to assess the durability of effect.|Baseline up to Month 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||days||Standard Deviation|Mean
2733349|NCT00996489|Secondary|Number of Participants Who Received Each of the Six Coaptite Injections|Coaptite injection were given to any participant during the 36 months of evaluation.|Baseline up to Month 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value.|||participants|||Number
2733350|NCT00996489|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to Month 36|The SES was the subset of all participants enrolled who were exposed to the study device at least once.|||participants|||Number
2733351|NCT00996489|Primary|Number of Participants With Change From Baseline in Stamey Grade Scores Over Time|The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).|Baseline up to Months 6 and 12|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value.|||participants|||Number
2733352|NCT00996489|Primary|Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline|The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).|Months 6, 12, 18, 24, 30, and 36|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||participants|||Number
2733353|NCT00996489|Primary|Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12|The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).|Baseline up to Month 12|The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. The FAS, where 6 and 12 months follow up data for the participants was available.|||participants|||Number
2740732|NCT00946023|Secondary|Engraftment|Percentage of patients who engrafted neutrophils and platelets.|Day 60||||percentage of participants||95% Confidence Interval|Number
2733354|NCT00996489|Primary|Incontinence Status as Assessed by Stamey Grade Score|The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).|Baseline and Months 6, 12, 18, 24, 30, and 36|The full analysis set (FAS) consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||score on a scale||Standard Deviation|Mean
2733355|NCT00996476|Primary|The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications|"The table below shows the number of participants who met response-guided treatment (RGT) stopping criteria in the TMC435 treatment groups. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20 were to stop all study medication (TMC435, PegIFNα-2a, and ribavirin) at Week 24. All other participants continued PegIFNα-2a and ribavirin until Week 48. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
2733356|NCT00996476|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|"The table below shows the median time in hours to reach the maximum plasma concentration (tmax) of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.|||Hours||Full Range|Median
2733357|NCT00996476|Primary|The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435|"The table below shows the mean AUC24 of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.|||ng∙h/mL||Standard Deviation|Mean
2733358|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling)|"The table below shows the mean predose plasma concentration (C0h) for participants in the 2 TMC435 50 mg treatment groups combined and for participants in the 2 TMC435 100 mg treatment groups combined who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4 to 6|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Standard Deviation|Mean
2733359|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling)|"The table below shows the mean (standard deviation) predose plasma concentration (C0h) for participants in each treatment group at Weeks 4, 12, and 24. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, and 24|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Standard Deviation|Mean
2733360|NCT00996476|Primary|The Percentage of Participants With Sustained Virologic Response (SVR)|"The table below shows the percentage of participants with a SVR4, SVR12, and SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) (up to Weeks 24 or 48) and at 4, 12, and 24 weeks, respectively, after the last dose of treatment. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
2733361|NCT00996476|Primary|The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT)|"The table below shows the number of participants whose ALT results were within the normal range on Day 1 (initial day of treatment), Week 24, 48, and EOT (up to Weeks 24 or 48).The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
2733362|NCT00996476|Primary|Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period|"The table below shows the mean (standard deviation) of the actual HCV RNA values by treatment group at Baseline and Weeks 4, 12, 24, 48, end of treatment (EOT, up to Weeks 24 or 48), Weeks 60 and 72 (Week 24 in the post-treatment follow-up period). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||log10 IU/mL||Standard Deviation|Mean
2733363|NCT00996476|Primary|The Percentage of Participants With Viral Relapse|"The table below shows the percentage of participants in each treatment group who experienced viral relapse within 12 weeks (ie, at Week 36 or 60) after actual end of treatment (EOT) (up to Week 24 or 48). Viral relapse was defined as confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels during the post treatment follow-up period at Weeks 36 or 60 in participants with undetectable plasma HCV RNA at EOT. The statistical analysis shows the difference in treatments (ie, each TMC435 group minus PR48 control) in viral relapse. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
2733364|NCT00996476|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the 48 week treatment period with at least one study medication (TMC435 or PegIFNα-2a and ribavirin). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to EOT (up to Week 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
2733365|NCT00996476|Primary|The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up|"The table below shows the percentage of participants in each treatment group with plasma HCV RNA levels undetectable or below the limit of quantification (<1.2 log10 IU/mL detectable ) at time points during treatment and post treatment follow-up.The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
2733366|NCT00996476|Primary|The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period|"The table below shows the percentage of participants in each treatment group with a decrease of greater than (>) or equal (=) to 2 log10 IU/mL from baseline in plasma HCV RNA levels at time points during the treatment period and post treatment follow-up period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
2733367|NCT00996476|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study|"The table below shows the percentage of participants in each treatment group with undetectable plasma HCV RNA levels at Weeks 4, 12, 24, 48, and end of treatment (EOT, up to Week 24 or 48). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the Number of Participants Analyzed.NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
2733381|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Irinotecan|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month||||milligrams/meter squared|||Number
2733368|NCT00996476|Primary|Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4|"The table below shows the least-squares (LS) mean change and 95% confidence intervals (CI) change from baseline at Week 4 in HCV RNA levels for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg). The statistical analyses show the difference in LS mean change from baseline from the PR48 control group and the 95% CI for each dose group (ie, each TMC435 dose group minus PR48 control). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1 (Baseline) and Week 4|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2733369|NCT00996437|Secondary|Very Severe Visual Acuity Loss (Defined as <20/800)||4,8 and 12 weeks|Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis.|||percentage of participants|||Number
2733370|NCT00996437|Secondary|Severe Visual Acuity Loss (Defined as <20/200)||4,8 and 12 weeks|Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis.|||percentage of participants|||Number
2733371|NCT00996437|Secondary|Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit||4, 8 and 12 weeks|This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure.|||percentage of participants|||Number
2733372|NCT00996437|Secondary|Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status|Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.|4, 8 and 12 weeks|Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement.|||letter scores||Standard Deviation|Mean
2733373|NCT00996437|Secondary|Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength|Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.|4, 8 and 12 weeks|This analysis followed the intent-to-treat principle|||percentage of eyes|||Number
2733374|NCT00996437|Secondary|Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy|"The proportion of eyes with complete panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test."|within 112 days of randomization|The secondary analysis followed the intent-to-treat principle and included all randomized eyes.|||percentage of eyes|||Number
2733375|NCT00996437|Primary|Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)||Baseline to 16 weeks|Adverse events for each participants was collected throughout study duration.|||participants|||Number
2733376|NCT00996437|Primary|"Treatment or Failure Defined as Vitrectomy"|The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.|within 112 days of randomization|The primary analysis followed the intent-to-treat principle and included all randomized eyes.|||percentage of participants|||Number
2733377|NCT00996372|Secondary|Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)|The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).|change from baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Least Squares Mean
2733378|NCT00996372|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire).|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.|||units on a scale||Standard Deviation|Mean
2733379|NCT00996372|Primary|Change From Baseline in the Number of Satisfying Sexual Events|A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.|||sexual events||Standard Deviation|Mean
2733380|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month||||milligrams|||Number
2733386|NCT00996307|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set (PPS).|||Titres||95% Confidence Interval|Geometric Mean
2733387|NCT00996307|Secondary|Antibody Response Based on Baseline Seropositivity|Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set (PPS).|||Percentages of Subjects||95% Confidence Interval|Number
2733388|NCT00996307|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup on the per-protocol set (PPS).|||Titers||95% Confidence Interval|Geometric Mean
2733389|NCT00996307|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set(PPS).|||Percentages of Subjects||95% Confidence Interval|Number
2733390|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination|Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.|Day 22 to 28|The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination.|||Participants|||Number
2733391|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination|Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.|Day 1 to 7|The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS.|||Participants|||Number
2733392|NCT00996307|Secondary|Immunogenicity Measurement by Geometric Mean Titers (GMT)|Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.|21 days after each vaccination|The analysis was done on the Full Analysis Set (FAS).|||Titers||95% Confidence Interval|Geometric Mean
2733393|NCT00996307|Primary|Antibody Responses After the First and Second Vaccinations|CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.|21 days after each vaccination|The analysis was done on the per-protocol set (PPS).|||Percentages of Subjects||95% Confidence Interval|Number
2733394|NCT00996281|Secondary|Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)|Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations).|Baseline and Week 52|Safety analysis set.|||percentage of participants|||Number
2733395|NCT00996281|Primary|Percentage of Participants With at Least 1 Adverse Event|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality.|From Week 0 (Day 1) to Week 52.|Safety analysis set: All participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2733396|NCT00996216|Secondary|Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)|SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.|From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.|||Participants|||Number
2733397|NCT00996216|Primary|Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population|||Participants|||Number
2733441|NCT00995930|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples were collected to analyze hsCRP.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||mg/L||95% Confidence Interval|Geometric Mean
2733398|NCT00996216|Primary|Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population|||Participants|||Number
2733399|NCT00996216|Primary|Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2|Visual acuity (VA) is defined as acuteness or clearness of vision.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population: all participants in the Pre-antiviral Safety Population|||Participants|||Number
2733400|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2|Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population|||Participants|||Number
2733401|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1|Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.|||Participants|||Number
2733402|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population|||Participants|||Number
2733403|NCT00996216|Primary|Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.|||Participants|||Number
2733404|NCT00996216|Primary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy|||Participants|||Number
2733405|NCT00996216|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study|||Participants|||Number
2733406|NCT00996216|Secondary|Number of Particpants Who Initiated Antiviral Therapy|The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.|From the start of the investigational product up to 9 weeks (median of 21 days)|Pre-antiviral Safety Population|||Participants|||Number
2733407|NCT00996216|Secondary|Platelet Counts at the Indicated Time Points|Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Pre-antiviral Safety Population|||Gi/L||Standard Deviation|Mean
2733408|NCT00996203|Secondary|Erythrocyte Sedimentation Rate|ESR (mm/hr) is used to determine the acute phase response.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mm/hr||Standard Deviation|Mean
2733410|NCT00996203|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of participants|||Number
2733411|NCT00996203|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of participants|||Number
2733412|NCT00996203|Secondary|Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of participants|||Number
2733413|NCT00996203|Primary|Change in HAQ Score at Week 24|HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline and Week 24|ITT population|||units on a scale||Standard Deviation|Mean
2733414|NCT00996203|Primary|Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment|HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|ITT population:|||percentage of participants|||Number
2733415|NCT00996203|Secondary|Change in DAS28 Score From Baseline to Week 24||Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2733416|NCT00996203|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||units on a scale||Standard Deviation|Mean
2733417|NCT00996203|Secondary|Change in General Health Assessed by VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
2733418|NCT00996203|Secondary|Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of Participants|||Number
2733419|NCT00996203|Secondary|General Health Score as Assessed by EQ-5D VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mm||Standard Deviation|Mean
2733420|NCT00996203|Secondary|Change in EQ-5D Score at Week 24 From Baseline|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2733452|NCT00995865|Secondary|Distribution of Geometric Mean Antibody Titers (GMTs) to Yellow Fever 17D Virus.|Geometric mean antibody titers (GMT) neutralizing antibody titers for each dose groups.|GMT titers measured at days 21, 31 and 42 for different dose rates.||||Geometric Antibody titers||95% Confidence Interval|Geometric Mean
2747757|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)|12 hours|Safety population|||Ratio||Full Range|Mean
2733421|NCT00996203|Secondary|European Quality of Life - 5 Dimensions (EQ-5D) Score|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||units on a scale||Standard Deviation|Mean
2733422|NCT00996203|Secondary|Pain Score as Assessed by Visual Analogue Scale (VAS)|Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mm||Standard Deviation|Mean
2733423|NCT00996203|Primary|Health Assessment Questionnaire (HAQ) Score|HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.|Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit|Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit.|||units on a scale||Standard Deviation|Mean
2733424|NCT00996164|Primary|Change From Baseline in the SSE Count From Baseline to 24 Weeks|"The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).~Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.~An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry."|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.|||SSEs||Standard Deviation|Mean
2733425|NCT00996164|Primary|The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.|The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Mean
2733426|NCT00996125|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733427|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 - 29) after any vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733428|NCT00996125|Secondary|Number of Subjects Reporting Pregnancies and Pregnancy Outcomes||Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733429|NCT00996125|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs)|"Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.~MSCs were collected regardless of causal relationship to vaccination and intensity."|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2734334|NCT00989014|Primary|Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.||Baseline and every hour for 12 hours following application||||participants|||Number
2733430|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0 - 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2733431|NCT00996125|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 7 days (Days 0 - 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2733432|NCT00996125|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.|At Month 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2733433|NCT00996125|Primary|Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens|Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month after the third dose (at Month 7)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2733434|NCT00996034|Primary|Mean of the Average Nicotine Binding % at Scan 1 and Scan 2|nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.|3 months||||percentage of average nicotine binding||Standard Deviation|Mean
2733435|NCT00995930|Secondary|Pharmacokinetics: ACZ885 Serum Concentrations|Blood samples were collected to analyze the ACZ885 serum concentrations.|pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12|Only participants from the PK analysis set, who had evaluable data at each time point, were included in the analysis for that time point. The PK analysis set included randomized participants from the ACZ885 arm who received at least one dose of study medication.|||ng/mL||Standard Deviation|Mean
2733436|NCT00995930|Secondary|Change From Baseline Insulin Resistance (HOMA-IR)|Blood samples were collected to analyze insulin resistance. Insulin resistance was calculated by the Homeostasis Model Assessments of insulin resistance (HOMA-IR)) as follows: HOMA-IR: The product of basal glucose (mmol/L) and insulin (µU/mL) levels divided by 22.5 [i.e., HOMA-IR = basal glucose*basal insulin/22.5].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||IR score||95% Confidence Interval|Geometric Mean
2733437|NCT00995930|Secondary|Change From Baseline in Beta Cell Function (HOMA-B)|Blood samples were collected to analyze beta cell function. Beta cell function was calculated by the Homeostasis Model Assessments (of beta cell function (HOMA-B) as follows: HOMA-B: The product of 20 and basal insulin (µU/mL) levels divided by the value of basal glucose (mmol/L) concentrations minus 3.5 [i.e., HOMA-B = 20*basal insulin/(basal glucose-3.5)].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||percentage of beta cell function||95% Confidence Interval|Geometric Mean
2733438|NCT00995930|Secondary|Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)|Blood samples were collected to analyze the 2 hour glucose post OGTT.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||mmol/L||95% Confidence Interval|Geometric Mean
2733439|NCT00995930|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|Blood samples were collected to analyze HbA1c.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||percentage||95% Confidence Interval|Geometric Mean
2733440|NCT00995930|Secondary|Change From Baseline in Fasting Plasma Glucose|Blood samples were collected to analyze fasting plasma glucose.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||mmol/L||95% Confidence Interval|Geometric Mean
2733685|NCT00993421|Secondary|Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint|Percentage change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT|||percent change||Standard Deviation|Least Squares Mean
2733442|NCT00995930|Secondary|Change From Baseline in Aortic Strain|Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle. The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively..|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||ratio||Standard Error|Least Squares Mean
2733443|NCT00995930|Secondary|Change From Baseline in Plaque Composition|During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired. In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||mm^2||Standard Deviation|Mean
2733444|NCT00995930|Secondary|Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||ms^-1||Standard Error|Least Squares Mean
2733445|NCT00995930|Primary|Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)|For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding. Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta. The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans. For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence. The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region. The mean values reported here for the carotid are reported for the proximal common carotid region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||mm^2||Standard Error|Least Squares Mean
2733446|NCT00995930|Primary|Change From Baseline in Aortic Distensibility|Two axial, ECG-gated, steady state free precession (SSFP) 'cine' images were acquired during breath-hold to determine aortic distensibility. The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm. Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||mmHg^-1||Standard Error|Least Squares Mean
2733447|NCT00995930|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|12 months|Safety analysis set: The safety analysis set included all randomized participants who received at least one dose of study drug.|||Number of participants|||Number
2733448|NCT00995904|Primary|Half-life (t1/2) of Budesonide After Administration of MAP0020|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|12 hours|Patients with available data at specified time points are included in the analysis population.|||minutes||Standard Deviation|Mean
2733449|NCT00995904|Primary|AUC(0-inf) of Budesonide After Administration of MAP0020|The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.|||pg*min/ml||Standard Deviation|Mean
2733450|NCT00995904|Primary|Cmax of Budesonide After Administration of MAP0020|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Mean
2733451|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.~After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.~Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.~At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 22 up to 42 Days.|Subjects were to combined at days 22 to 42 . At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.|||participants|||Number
2733453|NCT00995865|Secondary|Percentage of Subjects With Seroconversions or Who Are Seropositive Using 2 Dose Levels of XRX-001|Secondary immunogenicity endpoints will use 2 dose levels of XRX-001 inactivated yellow fever vaccine determined by 50% plaque reduction neutralization test (PRNT50). Dose groups were to be compared for neutralizing antibody seroconverison rate, distribution of antibody titers, and geometric mean antibody titers (GMTs) to yellow fever 17D virus. The seroconversion rates and GMT neutralizing antibody titers for each dose group and all dose groups combined; The reverse cumulative distribution curve of antibody titers;|Days 21 and 42, 12 months|Seropositive was to show a significant level of serum antibodies, or other immunologic marker in the serum, indicating previous exposure to the infectious agent being tested. In immunology, seroconversion is the time period during which a specific antibody develops and becomes detectable in the blood.|||Percentage of subjects||95% Confidence Interval|Number
2733454|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.~After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.~Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.~At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 0 up to 21 Days|Subjects were to return to the clinic on Days 3,10, 21, 24, 31,and 42 with the second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.|||participants|||Number
2733455|NCT00995774|Secondary|A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).||pre-treatment, post treatment|Data initially collected but could not interpret results due to a lack of resources and incomplete data analysis. No further staff, tools, or information is available to report conclusions.||||||
2733456|NCT00995774|Secondary|Action Research Arm Test|This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2||||units on a scale||Standard Deviation|Mean
2733457|NCT00995774|Primary|Fugl-Meyer Test of Motor Function|This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2||||units on a scale||Standard Deviation|Mean
2733458|NCT00995761|Primary|We Conducted the Present Phase II Study to Investigate the Efficacy and Safety of a Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable NSCLC.|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)|after every 2 cycles of docetaxel and cisplatin||2012-12-31|12/2012||||
2733459|NCT00995761|Secondary|Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment||From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin|||||||
2733460|NCT00995761|Primary|Response Rates Confirmed With CT or MRI|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0."|after every 2 cycles of docetaxel and cisplatin|The sample size was calculated according to Simon's two-stage optimal design.The statistical evaluation was performed based on an ITT analysis. Descriptive statistics are reported as proportions and medians. OS and TTP were assessed by the K-M method, and the 95% CI for the median time to events was computed.|||percentage of participants||95% Confidence Interval|Number
2733461|NCT00995722|Secondary|Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25||4 months||||units on a scale||95% Confidence Interval|Mean
2733462|NCT00995722|Secondary|Change in Quality of Life as Measured by the MG-QOL-15 Score||4 Months||||units on a scale||95% Confidence Interval|Mean
2733463|NCT00995722|Secondary|Change in Quality of Life as Measured by the NEI-VFQ-25 Measures||4 months||||units on a scale||95% Confidence Interval|Mean
2733464|NCT00995722|Secondary|Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16||4 months||||units on a scale||95% Confidence Interval|Mean
2733465|NCT00995722|Primary|Treatment Failure|Failure to achive sustatined minimal manifestation status by week 16|4 months||||percentage of participants||95% Confidence Interval|Number
2733466|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment|Patients number of occurences during a 24 week period.|24 weeks|Full analysis set|||Participants|||Number
2733479|NCT00995566|Primary|Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline|Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.|||percentage of participants|||Number
2733467|NCT00995709|Secondary|To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form.|The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.|baseline and wk 24 (end of study)|Full Analysis set|||change from baseline score||Standard Deviation|Mean
2733468|NCT00995709|Secondary|To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.|The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.|screening, and wk 24 (end of study)|Full Analysis Set|||Score||Standard Deviation|Mean
2733469|NCT00995709|Secondary|To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography.|Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.|baseline, and wk 24 (end of study)|(Full Analysis Set)|||change from baseline : micrometers||Standard Deviation|Mean
2733470|NCT00995709|Secondary|Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)|For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.|24 weeks|Full Analysis Set|||immunosuppressive medication score||Standard Deviation|Mean
2733471|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment||Baseline to week 24|Full Analysis Set|||Ocular Exacerbations||Standard Deviation|Mean
2733472|NCT00995670|Primary|Forearm Blood Flow|endothelial (forearm blood flow) responses to acetylcholine stimulation at baseline, and under conditions of high glucose before and after ischemia/reperfusion injury, and same with the addition of an intervention: sevoflurane (Arm 1), vitamin C (Arm 2), and high statin (Arm 3).|Baseline, Glucose Control, 15-min post ischemia||||ml/100 ml tissue/min||Standard Error|Mean
2733473|NCT00995566|Primary|Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease|The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.|Baseline up to year 1|FAS|||percentage of participants|||Number
2733474|NCT00995566|Primary|Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results|Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS|||participants|||Number
2733475|NCT00995566|Primary|Concomitant Medications|Number of participants with concomitant medication usage reported by drug categories.|Baseline, monthly up to 1 year|Data not summarized due to the small number of participants in database.|||participants|||Number
2733476|NCT00995566|Primary|Clinical Status Since Last Visit|Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.|||participants|||Number
2733477|NCT00995566|Primary|Adverse Events (AEs) by Seriousness and Relationship to Treatment|Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS|||participants|||Number
2733478|NCT00995566|Primary|Duration of Exposure to Thelin|Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS' Thelin start date was used.|1 Year|FAS|||months||Standard Deviation|Mean
2733480|NCT00995566|Primary|Percentage of Participants With a Decrease in Hemoglobin Post-baseline|Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.|||percentage of participants|||Number
2733481|NCT00995566|Primary|Percentage of Participants With Elevated Liver Function Post-baseline|Elevated liver function: greater than 3 times the upper limit of normal (>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Full Analysis Set (FAS): participants enrolled in Patient Registry of Sitaxentan in Europe (PROSE). Number of participants analyzed (N): participants with evaluable data.|||percentage of participants|||Number
2733482|NCT00995553|Secondary|Functional Capacity - University of California, San Diego Performance-Based Skills Assessment|The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2733483|NCT00995553|Primary|Cognitive Assessment - MATRICS Consensus Cognitive Battery|The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.|||T-score||Standard Deviation|Mean
2733484|NCT00995501|Secondary|1 Year Mortality|All-cause mortality|1 year after surgery||||Participants|||Count of Participants
2733485|NCT00995501|Primary|Major Perioperative Morbidity|Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.|30 day after surgery||||Participants|||Count of Participants
2733486|NCT00995488|Secondary|Median Overall Survival|The Median Overall Survival was captured in months.|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.|||months||95% Confidence Interval|Median
2733487|NCT00995488|Primary|Percentage of Participants With a Partial or Complete Response|"Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response [PR] + Complete Response[CR]) to therapy.~Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions.~Complete Response: Disappearance of all target lesions."|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.|||percentage of participants||95% Confidence Interval|Number
2733488|NCT00995475|Secondary|OUCC|Overnight urinary cortisol creatinine ratio|4 weeks||||nmol/mmol||95% Confidence Interval|Geometric Mean
2733489|NCT00995475|Secondary|Alveolar Nitric Oxide||4 weeks||||ppb||95% Confidence Interval|Geometric Mean
2733490|NCT00995475|Primary|CRP|C-reactive protein|4 weeks||||mg/L||95% Confidence Interval|Geometric Mean
2733491|NCT00995449|Primary|This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.|KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)|Weeks 14 & 30|This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.|||Participants|||Number
2733492|NCT00995436|Secondary|Patient Perception of the Different Treatment Methods, Including Surgical Experience||2 years|||||||
2733493|NCT00995436|Primary|Anchorage Loss Measured From 3-D Model Scanning||2 years||||mm||Standard Deviation|Mean
2733494|NCT00995410|Secondary|Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation|Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation|12 months|Overall Safety Population. Events were collected by systematic assessment. One subject reported two adverse events leading to discontinuation from the study. SOC from vocabulary, MedDRA (12.1).|||participants|Participants||Number
2733495|NCT00995410|Primary|Number of Subjects Monitored for Long-term Safety of PA32540|Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).|12 months||||participants|||Number
2733496|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.~The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value"|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.|||units on a scale||95% Confidence Interval|Mean
2733497|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.|||units on a scale||95% Confidence Interval|Mean
2733498|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.~The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value"|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.|||units on a scale||95% Confidence Interval|Mean
2733499|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.|||units on a scale||95% Confidence Interval|Mean
2733500|NCT00995345|Secondary|Percentage of Patients Requiring Rescue Therapy for Elevated Glucose|Percentage of Subjects Requiring Rescue Therapy - Intent-to-Treat Population|24 weeks of treatment.||||% of subjects in group|||Number
2733501|NCT00995345|Secondary|Percentage of Patients Achieving HbA1c Less Than 7%|Subjects Achieving Target of Hemoglobin A1c <7.0% at Week 24 with LOCF - Intent-to-Treat Population|24 weeks||||% of subjects in group|||Number
2733502|NCT00995345|Secondary|Change in Body Weight|Mean Change in Body Weight (kg) from Baseline to Week 24 with LOCF- ITT|24 weeks||||kg body weight on scale||Standard Error|Least Squares Mean
2733503|NCT00995345|Primary|Change in HbA1c From Baseline (Week 0) to Week 24|Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)|Week 24|Conducted analyses of ITT population of change in HbA1c from baseline (Week 0) to Week 24. If the Wk 24 measurement was missing, the last valid post-baseline observation (LOCF) algorithm was used to impute Week 24 value (1 on-treatment value required). Efficacy data collected after the initiation of rescue therapy was excluded from the analyses.|||% HbA1c||95% Confidence Interval|Least Squares Mean
2733504|NCT00995215|Primary|The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes|The effects of SCS with temporarily placed parallel wire leads and then with permanently implanted disc electrodes on airway pressure generation in each participant was evaluated in the operating room. The wire electrodes were temporarily placed (immediately prior to placement of disc electrodes as part of the current clinical trial) over the surface of the spinal cord on the lower back. These electrodes were activated, and the degree of expiratory muscle activation were assessed. The wire electrodes were then removed. Small, disc electrodes were then permanently implanted to stimulate expiratory muscles and restore cough. All measurements were repeated. Since SCS with the disc electrode leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.|intra-operative|Patients with spinal cord injury with expiratory muscle paralysis.|||cmH2O||Standard Error|Mean
2733505|NCT00995085|Primary|Safety and Tolerability|Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug|24 hours after drug adminstration||||events|||Number
2733506|NCT00995072|Secondary|Change in Sexual Functioning Questionnaire Score|This scale is a self-reported instrument used to detect sexual functioning. The scale ranges from 14 to 70. The higher scores reflects higher sexual functioning.|Baseline, 12 weeks|The number of participants analyzed for the measure are participants that had data available for both of the study periods.|||units on a scale||Standard Deviation|Mean
2733507|NCT00995072|Primary|Change in Female Sexual Function Index|This scale is a self-reported instrument used to detect female sexual function. The scale ranges from 2 to 36. The higher score indicates higher sexual function.|Baseline, 12 weeks|The number of participants analyzed for the measure are participants that had data available for both of the study periods.|||units on a scale||Standard Deviation|Mean
2733508|NCT00995020|Secondary|Time Spent to Perform the Procedure|Time was recorded from insertion until removal of the vaginal speculum.|Time spent from randomization to complete the procedure||||minuts||Standard Deviation|Mean
2733509|NCT00995020|Primary|Endocervical Margin Not Free of Disease.|Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.|3 months after the surgery is performed.|All data were analysed bu intention to treat.|||participants|||Number
2733510|NCT00995007|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|70 months and 19 days||||participants|||Number
2733511|NCT00995007|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, up to 1.5 years|The group data is displayed per the report provided to the Food and Drug Administration.|||Months||95% Confidence Interval|Median
2733512|NCT00995007|Primary|Progression Free Survival at 6 Months|Percentage of participants who are alive and progression-free at 6 months.|6 months|The group data is displayed per the report provided to the Food and Drug Administration.|||percentage of participants|||Number
2733513|NCT00994929|Secondary|The Mechanism of Study Drug Effect by VWF mRNA.||within 11 days of study drug.||||fold increase||Full Range|Mean
2733514|NCT00994929|Secondary|The Frequency of Adverse Events||within 11 days of study drug||||participants|||Number
2733515|NCT00994929|Primary|Biologic Effects by Coagulation Tests|"VWF activity was measured by ristocetin-induced platelet agglutination using a Chronolog aggregometer11-14 and VWF:Ag by sandwich ELISA, using anti-VWF antibodies (DakoA082, Carpintera CA). Results were expressed in percent, with normal human plasma pool designated 100%, and severe type 3 VWD plasma used as the negative control"|within 4 days of study drug.|Four subjects had VWD and five subjects had mild hemophilia A|||percentage of normal||Standard Error|Mean
2733516|NCT00994760|Secondary|Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...|Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more|after therapy with Instanyl (last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed'). N= number of valid cases"|||units on a scale||Standard Deviation|Mean
2733517|NCT00994760|Secondary|Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed') =N."|||units on a scale||Standard Deviation|Mean
2733518|NCT00994760|Secondary|Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|after therapy with Instanyl (first/last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.~All patients with valid values ('as observed'). N= number of valid cases."|||units on a scale||Standard Deviation|Mean
2733519|NCT00994760|Secondary|Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
2733520|NCT00994760|Secondary|Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
2733521|NCT00994760|Secondary|Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)|5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases."|||units on a scale||Standard Deviation|Mean
2733522|NCT00994760|Secondary|Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed')."|||units on a scale||Standard Deviation|Mean
2733523|NCT00994760|Secondary|Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
2733524|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5|conspicuous score <1.5 inconspicuous score ≥1.5|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||participants|||Number
2733525|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)|Scale: 0=worst, 5=best|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=93~Last Visit N=81"|||units on a scale||Standard Deviation|Mean
2733526|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20|"0= conspicuous ≤20~1= inconspicuous >20"|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||participants|||Number
2733527|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)|Scale: 0=complete impairment, 43=no impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=93~Last Visit N=82"|||units on a scale||Standard Deviation|Mean
2733528|NCT00994760|Secondary|Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)|Scale: 0=no impairment, 70=complete impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=92~Last Visit N= 80"|||units on a scale||Standard Deviation|Mean
2733529|NCT00994760|Secondary|Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?|Scale: 0=not at all, 10=completely|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=94~Last Visit N=83"|||units on a scale||Standard Deviation|Mean
2740891|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2733530|NCT00994760|Secondary|Patient: How do You Feel Today?|Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=94~Last Visit N=83"|||units on a scale||Standard Deviation|Mean
2733531|NCT00994760|Secondary|Patient: Description of Pain at Initial Visit|0=no pain, 10= most intense pain imaginable|initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed') =N."|||units on a scale||Standard Deviation|Mean
2733532|NCT00994760|Secondary|Patient: How Many Episodes of Pain You Experience on Average?||initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit."|||episodes per day||Standard Deviation|Mean
2733533|NCT00994760|Primary|Physician: What is the Current Treatment Needs of Your Patient Regarding ...|Scale: 0=no, 1=low, 2=medium, 3=high|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||units on a scale||Standard Deviation|Mean
2733534|NCT00994760|Primary|Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N=number of valid cases."|||units on a scale||Standard Deviation|Mean
2733535|NCT00994760|Primary|Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)|5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
2733536|NCT00994760|Primary|Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed')= N."|||units on a scale||Standard Deviation|Mean
2733537|NCT00994760|Secondary|Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
2733538|NCT00994760|Primary|Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination|Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||units on a scale||Standard Deviation|Mean
2733539|NCT00994760|Primary|Dose of Instanyl|Initially prescribed dose/ most efficient single dose of Instanyl at study end|during therapy with Instanyl (planned: 28 days)|"Patients included and treated (without imputation of missing values), intention to treat.~All patients included"|||participants|||Number
2733540|NCT00994682|Secondary|Bone Mineral Density|Bone mineral density measured at the levels of spine, femoral neck, hip, and wrist by DXA.|18 and 36 months|Data analysis included 78 patients at month 18 and 62 at month 36 (based on DXA availability).|||g/cm^2||Standard Deviation|Mean
2733541|NCT00994682|Secondary|Molecular Pathways of Liver Glucose and Lipid Signaling; Inflammatory Pathways; Oxidative Stress; Other.||At 18 (2nd liver biopsy) and 36 (3rd liver biopsy) months.|||||||
2733542|NCT00994682|Secondary|Osteoporotic Fractures|Number of patients with osteoporotic fractures|18 and 36 months||||Participants|||Count of Participants
2733543|NCT00994682|Secondary|Prevention of the Onset of T2DM and/or Reversal From IFG/IGT to NGT in Non-diabetics.|Number of patients developing T2DM and number of patients regressing to NGT among patients with prediabetes (IFG/IGT).|18 months|Only patients with prediabetes are included in this analysis|||Participants|||Count of Participants
2733544|NCT00994682|Secondary|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (CK-18).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||U/L||95% Confidence Interval|Mean
2733545|NCT00994682|Secondary|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (Adiponectin).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||μg/ml||95% Confidence Interval|Mean
2733546|NCT00994682|Secondary|Total Body Fat|Total body fat measured by dual-energy x-ray absorptiometry (DXA)|Months 18|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively).|||Percentage of body weight that is fat||Standard Deviation|Mean
2733547|NCT00994682|Secondary|Body Mass Index (BMI)||Months 18 and 36|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||kg/m^2||Standard Deviation|Mean
2733548|NCT00994682|Secondary|Skeletal Muscle Insulin Sensitivity|Rate of glucose disappearance (Rd) during high-dose insulin infusion. The rate of plasma glucose disappearance was calculated using Steele's non-steady-state equation.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||mg/kgLBM/min||95% Confidence Interval|Mean
2733549|NCT00994682|Secondary|Adipose Tissue Insulin Sensitivity|Suppression of free fatty acids by low dose insulin (i.e., percentage of reduction of plasma FFA with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((plasma FFA without insulin - plasma FFA with insulin infusion)/plasma FFA without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||% of suppression of FFA||95% Confidence Interval|Mean
2733550|NCT00994682|Secondary|Hepatic Insulin Sensitivity|Suppression of endogenous glucose production (Supp EGP) by low dose insulin (i.e., percentage of reduction of EGP with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((EGP without insulin - EGP with insulin infusion)/EGP without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||% of suppression of EGP||95% Confidence Interval|Mean
2733551|NCT00994682|Secondary|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Homeostatic model assessment of insulin resistance (HOMA-IR) is a method for assessing insulin resistance (IR) from basal fasting plasma glucose (FPG) and fasting plasma insulin (FPI). It is calculated as (FPG x FPI)/405.|18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||Arbitrary units||95% Confidence Interval|Mean
2733552|NCT00994682|Secondary|Liver Fat by Magnetic Resonance and Spectroscopy (MRS).|Liver fat content was calculated as the fat fraction: 100*(area under the curve [AUC] of fat peak / [AUC of fat peak + AUC of water peak]).|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||percentage of fat in liver||Standard Deviation|Mean
2733553|NCT00994682|Secondary|Liver Transaminases (AST and ALT).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||U/L||Standard Deviation|Mean
2733554|NCT00994682|Secondary|Mean Individual Histological Scores|Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis|Month 36||||units on a scale||95% Confidence Interval|Mean
2733555|NCT00994682|Secondary|Individual Histological Scores|"Number of patients with improvement of at least 1 grade in each of the histological parameters.~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal, 1A = Mild, zone 3, perisinusoidal delicate fibrosis; 1B = Moderate, zone 3, perisinusoidal dense fibrosis; 1C = Portal/periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis"|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
2733556|NCT00994682|Secondary|Mean Individual Histological Scores|Mean change in individual scores compared to baseline. Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis|Baseline and Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||units on a scale||95% Confidence Interval|Mean
2733557|NCT00994682|Secondary|Number of Participants With Resolution of NASH|Resolution of NASH was defined as absence of NASH after 18 months of therapy in patients with definite NASH (presence of zone 3 accentuation of macrovesicular steatosis of any grade, hepatocellular ballooning of any degree, and lobular inflammatory infiltrates of any amount) at baseline.|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
2733558|NCT00994682|Primary|Liver Histology (Using Kleiner et al Criteria, Hepatology 2005)|"Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 .~The scoring system is based on the following grading:~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis."|At 18 months||||Participants|||Count of Participants
2733559|NCT00994643|Primary|Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma|Patients were enrolled based on having obtained complete remission or at least a partial remission. Efficacy was therefore determined by the number of patients that remained in remission following treatment.|1 year||||Participants|||Count of Participants
2733560|NCT00994604|Secondary|Changes in Airway Size by Computed Tomography|Changes in size airways as measured by computed tomography|baseline and after two weeks||||size in mm^2||Standard Deviation|Mean
2733561|NCT00994604|Primary|The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract|"Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100~Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100"|baseline and two weeks||||index||Standard Deviation|Mean
2733562|NCT00994461|Secondary|Incidence of Treatment-emergent, All-causality GI Body System Adverse Events|The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
2733563|NCT00994461|Secondary|Number of Gastroduodenal Erosions in Each Subject|Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Participants|||Number
2733564|NCT00994461|Secondary|Number of Gastroduodenal Ulcers in Each Subject|Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Participants|||Number
2733565|NCT00994461|Secondary|Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)|Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Participants|||Number
2733566|NCT00994461|Secondary|Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions|The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
2733567|NCT00994461|Secondary|Incidence of Any Gastric, and Duodenal Ulcers|The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
2733568|NCT00994461|Primary|Incidence of Gastroduodenal Ulcers|The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
2733569|NCT00994448|Primary|Feasibility of Retaining Adolescents in Trial|the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)|8 weeks|mean days retained in treatment for each grou[p|||days||Standard Deviation|Mean
2733570|NCT00994422|Primary|Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator.~Severe scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Local tolerability was assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
2733571|NCT00994422|Primary|Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)||Day 1 up to Day 28 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
2733572|NCT00994422|Primary|Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.|Days 2 up to Day 15 post-treatment|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
2733587|NCT00994123|Primary|Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination|"This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, with a median of 8.1 weeks||||weeks||95% Confidence Interval|Median
2740892|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||logMAR||Standard Deviation|Mean
2733573|NCT00994318|Primary|Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger|"Endpoint reported number of participants with/without events and was reached:~First time of initiation of additional or alternative anaemia management,~First time the subject reached the Hb trigger.~3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:~FCM (high ferritin target) compared with oral iron.~FCM (high ferritin target) compared with FCM (low ferritin target).~FCM (low ferritin target) compared with oral iron.~Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:~Without taking into account the Hb trigger.~Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory."|Up to 1 year after baseline|The Full Analysis Set (FAS) was used for the primary endpoint analysis, which consisted of all subjects randomised to treatment, received at least 1 dose of study treatment or, according to the protocol, were not treated due to ferritin value <100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment available.|||participants|||Number
2733574|NCT00994279|Secondary|Fatigue at 10 Weeks|FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.|10 weeks|Participants with 10 week outcome data. Note that one participant in the Wellness group was missing this outcome even though they completed the study.|||units on a scale||Standard Error|Least Squares Mean
2733575|NCT00994279|Primary|Retention|Proportion of participants completing the 10 week study|10 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2733576|NCT00994240|Primary|Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.|Clinical evidence of BCC recurrence post treatment|base line, every 3 months until 12 month completion|Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived.|||participants|||Number
2733577|NCT00994214|Secondary|Number of Subjects Reported Adverse Events During the Study|"For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.~TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study."|Up to Visit 10 (An average of 6.5 Months)|"Safety Population~Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received."|||Participants|||Number
2733578|NCT00994214|Secondary|Percentage Change in Ring Finger Circumference|Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.|Baseline (Day 1) and Month 6|ITT population. N=Number of subjects attended Month 6 (visit 9).|||Percentage of Change in Ring Finger circ||Standard Deviation|Mean
2733579|NCT00994214|Secondary|Changes in IGF-1||Baseline (Day 1) and Month 6|ITT population|||Percentage of ULN||Standard Deviation|Mean
2733580|NCT00994214|Secondary|Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6|Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline|0-3 hr on Baseline (Day 1) and Months 1, 3 and 6|N=Number of patients randomised to treatment in IGF-1 <2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.|||Percentage of change in mean GH||Standard Deviation|Mean
2733581|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 1|ITT population. N=Number of subjects attended Month 1 (visit 5).|||Percentage of subjects|||Number
2733582|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 3|ITT population. N=Number of subjects attended Month 3 (visit 7).|||Percentage of subjects|||Number
2733583|NCT00994214|Primary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 6|Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).|||Percentage of subjects|||Number
2733584|NCT00994175|Primary|Baseline - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score|Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired|Baseline|All subjects who completed both treatment phases of the study|||units on a scale||Standard Deviation|Mean
2733585|NCT00994175|Primary|16 Weeks - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score|Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired|16 weeks|All subjects who completed both treatment phases of the study|||units on a scale||Standard Deviation|Mean
2733586|NCT00994123|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Erlotinib in Formalin Fixed (FFPE) Tumor Samples|Tumor tissue samples were obtained from patients prior to enrollment. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to erlotinib can increase PFS in HRG-high patients.|Time from first dose to date of progression, with a median of 8.1 weeks|Patients with available tissue for heregulin testing|||months PFS||95% Confidence Interval|Median
2733616|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733588|NCT00994123|Primary|Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|"Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs.~The determined MTD was used as the recommended Phase 2 dose."|From date of first dose to 30 days after termination, the longest 175 weeks|All participants treated in the Phase 1 dose-escalation portion of the study|||dose level of MTD|||Number
2733589|NCT00994123|Primary|Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.|To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 175 weeks||||participants reporting DLTs|||Number
2733590|NCT00994110|Primary|To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo.||60 days||||percentage of participants|||Number
2733591|NCT00993967|Other Pre-specified|Measures of Safety and Tolerability: Haematological and Biochemical Laboratory Parameters|Safety haematological analysis were done at every visit. Analyses included red blood cell count, haemoglobin, haematocrit, red cell indices, white blood cell count including differential, platelet count Safety biochemistry were done at every visit. Analyses included sodium, potassium, chloride, bicarbonate, urea, creatinine, calcium, inorganic phosphate, glucose, total bilirubin, total protein, albumin, aspartate amiotransferase (AST), alanine aminotransferase (ALT), alkaline phosphotase, Gamma GT, creatine kinase (CK)^, cholesterol, triglycerides, uric acid.|Month 1, 3, 6, 12, 18 and 24|||||||
2733592|NCT00993967|Other Pre-specified|Measures of Safety and Tolerability: Electrocardiograms (ECGs)|12-lead ECG recordings were performed at every visit. Each ECG was measured using 3 complexes: PR interval in lead II or V2, QRS and QT intervals and heart rate in lead II, corrected QT intervals QTcB and QTcF.|Month 1, 3, 6, 12, 18 and 24|||||||
2733593|NCT00993967|Other Pre-specified|Measures of Safety and Tolerability: Physical Examinations and Vital Signs|Assessment of the head, eyes, ears, nose, throat, heart, chest, lungs, abdomen, extremities, peripheral pulses, skin and any other physical conditions of note.|Month 1, 3, 6, 12, 18 and 24|||||||
2733594|NCT00993967|Primary|Absolute Change in The International Cooperative Ataxia Rating Scale (ICARS)|The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline, Month 12 and month 24|Changes in Total ICARS Score for all patients completing the study (CC Population)|||units on a scale||Standard Deviation|Mean
2733595|NCT00993967|Primary|Measures of Safety and Tolerability: Nature and Frequency of Adverse Events (AEs)|Global Overvbiew of accurance of AEs-Safety population. The Safety population included all subjects who received at least one dose of the study medication.|overall study, up to 24 months||||participants|||Number
2733596|NCT00993954|Secondary|Proportion of Patients With RHS Not Identified by Nurse Pathway.||End of enrollment||||participants|||Number
2733597|NCT00993954|Secondary|Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.||Every 3 months during enrollment||||participants|||Number
2733598|NCT00993954|Secondary|Time to Discharge From ED (Minutes)||End of enrollment|2 missing data point in the physician group|||minutes||Full Range|Median
2733599|NCT00993954|Primary|Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls||10-15 minutes post reduction attempt||||percentage of patients reduced|||Number
2733600|NCT00993928|Secondary|Distress at Week 6|The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.|From baseline to week 7|All patients that completed a Distress Thermometer assessment at baseline and week 7 were included in the analysis.|||percentage of change||Full Range|Median
2733601|NCT00993928|Secondary|Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)|"The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as tense, angry, worn out, etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms."|At baseline and week 7|Patients that completed the POMS-B questionnaire at baseline and week 7 were used in this analysis.|||percentage of change||Full Range|Median
2733617|NCT00993668|Secondary|Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 216 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2734381|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent-to-treat population.|||Percent of Participants|||Number
2733602|NCT00993928|Secondary|Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)|The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.|Baseline and 7 weeks|Thirty-six patients from Arm A and 31 patients from Arm B had PSQI measurements available for analysis.|||percentage of participants|||Number
2733603|NCT00993928|Secondary|Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7.|"Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively: >~How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy) >~How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply) >~How many times did you awaken last night? >~How long did it take you to get to sleep last night? > > The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test."|Baseline and 7 weeks|In Arm A, 38 patients responded to questions during week 4 and 37 responded during week 7. In Arm B, 31 patients responded during week 4 and 30 responded during week 7.|||percentage of change||Full Range|Median
2733604|NCT00993928|Primary|Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7|"The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: How long did it take you to get to sleep last night? and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: When waking up after first falling asleep, how long did it take you to fall back to sleep? >~> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test."|Baseline and 7 weeks|In Arm A, 4 went off treatment prior to week 7 and 2 had missing data. 23 patients were able to respond to question 6A. In Arm B, 7 did not finish 7 weeks of treatment and 1 patient had missing data. 16 patients responded to question 6A. Therefore, Q3 and Q6A are based on 37 and 23 patients in Arm A and 30 and 23 patients from Arm B, respectively.|||percentage change||Full Range|Median
2733605|NCT00993915|Other Pre-specified|Percent Change From Baseline in Lipid Parameters at 1 Month|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.||||||
2733606|NCT00993915|Other Pre-specified|Change From Baseline in Lipid Parameters at 1 Month|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.||||||
2733607|NCT00993915|Secondary|Percent Change From Baseline in Lipid Parameters|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 6|FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.|||percent change||95% Confidence Interval|Mean
2733608|NCT00993915|Secondary|Change From Baseline in Lipid Parameters|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 6|FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.|||mg/dL||95% Confidence Interval|Mean
2733609|NCT00993915|Secondary|Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit||Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure.||||||
2733610|NCT00993915|Primary|Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit||Month 6|Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.|||percentage of participants||95% Confidence Interval|Number
2733611|NCT00993824|Primary|Hypoglycemia Percentage of Time <70 mg/dL Average by Group|Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||percentage of time <70 mg/dL||Standard Deviation|Mean
2733612|NCT00993824|Primary|Wake Norm AUC Average by Group (Normalized)|Wake glucose captured by continuous glucose monitoring (CGM).|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||mg/(dL/hr) (normalized)||Standard Deviation|Mean
2733613|NCT00993824|Primary|Sleep Norm AUC Average by Group (Normalized)|Overnight glucose captured by CGM.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||mg/(dL/hr) normalized||Standard Deviation|Mean
2733614|NCT00993824|Primary|Total Norm AUC Average by Group (Normalized)|Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||mg/(dL/hr) normalized||Standard Deviation|Mean
2733615|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733618|NCT00993668|Secondary|Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733619|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||Baseline, End of single blind period (week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers but with protective influenza antibody titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733620|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 180 were in the Per Protocol Set Pneumococcal (PPSP) population (90 Placebo, 90 CZP) without baseline protective titers. Of these 180 subjects 150 (75 Placebo, 75 CZP) had protective pneumococcal antibody titers and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733621|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 109 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733622|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733623|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733624|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2733625|NCT00993655|Secondary|Overall Survival|Time from the day of randomization to death from any cause.|During the study with median follow-up of 33 months||||months||95% Confidence Interval|Median
2733626|NCT00993655|Secondary|Progression Free Survival|Time from the day of randomization until the time when first observation of disease progression (earliest of the dates of first CA125 which meets progression definition and first objective relapse or progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, has been documented or when death due to any cause has been observed.|During the study with median follow-up of 33 months|All patients randomized to the study|||months||95% Confidence Interval|Median
2733627|NCT00993655|Primary|9-month Progression Rate Post-randomization|It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, recorded) has been documented or when death due to any cause has been observed was less than or equal to 9 months.|9 months|All randomized patients|||Porportion of participants|||Number
2733628|NCT00993616|Other Pre-specified|Duration of Progression-free Interval for All Patients||up to 5 years|Please note: this outcome measure is not an endpoint as per the protocol document. Data will not be reported.||||||
2733629|NCT00993616|Primary|Progression Free Survival at 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months|Eligible and treated patients|||percentage of participants|||Number
2733630|NCT00993616|Primary|Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0||Every cycle during treatment and 30 days after the end of treatment|Eligible and treated patients|||Participants|||Count of Participants
2733631|NCT00993616|Primary|Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1)|Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (version 1.1): Complete Response (CR) is disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Increasing Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest|From study entry, up to 5 years||||participants|||Number
2733632|NCT00993499|Secondary|Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin|Evaluation of laboratory parameters included assessment of the frequency of patients with ALT and AST elevations concurrent with elevated bilirubin and indicative of Hy's law cases.|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
2733633|NCT00993499|Secondary|Percentage of Patients With Drug-related AEs|Percentage of patients with drug-related adverse events (AEs).|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
2733634|NCT00993499|Secondary|Occurrence of Adverse Events According to CTCAE, Version 3.0|Percentage of participants with adverse events according to highest Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
2733635|NCT00993499|Secondary|AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of sirolimus at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733636|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)|Maximum measured plasma concentration of sirolimus at steady state (Cmax,ss)|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733637|NCT00993499|Secondary|AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of Afatinib at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2733638|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)|Maximum measured plasma concentration of Afatinib at steady state (Cmax,ss)|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2733639|NCT00993499|Secondary|Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.|"Exploratory examination of Epidermal growth factor (receptor)(EGFR) mutations (Exons 19, 20 and 21 and others) in serum/plasma DNA and tumour DNA.~This endpoint was not analysed in the study report as the available data was too limited."|Multiple time points during the trial|Treated set. This endpoint was not analysed in the study report as the available data was too limited.||||||
2733640|NCT00993499|Secondary|Rate of Disease Control|Rate of (unconfirmed) disease control defined as CR, PR, or stable disease (SD), according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
2733641|NCT00993499|Secondary|Objective Response|Rate of (unconfirmed) objective response, defined as complete response (CR) or partial response (PR) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
2733642|NCT00993499|Secondary|Best Overall Response|Best overall response (unconfirmed) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
2733643|NCT00993499|Primary|Occurrence of Dose Limiting Toxicities (DLT)|Number of participants with of dose limiting toxicities (DLT)|2 first cycles, 56 days|Treated set|||Participants|||Number
2733644|NCT00993473|Other Pre-specified|Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours).|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).|||mmol/L||Standard Deviation|Mean
2733645|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low FSBG (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low FSBG consisted of all low FSBG readings (values <70 mg/dL) performed at other times."|6 months|Same as for primary endpoint: mITT population.|||events per patient-year||Standard Deviation|Mean
2733646|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low CGMS Excursions (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low CGMS excursions consisted of all low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL."|6 months|Same as for primary endpoint: mITT population.|||events per patient-year||Standard Deviation|Mean
2733647|NCT00993473|Other Pre-specified|Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).|||mmol/L||Standard Deviation|Mean
2733648|NCT00993473|Other Pre-specified|Percent of Blood Glucose (BG) Within the Range of 70 - 180 mg/dL (3.9-10 mmol/L)|Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 - 180 mg/dL (3.9 - 10 mmol/L) inclusive.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).|||percent of CGMS values within the range||Standard Deviation|Mean
2733649|NCT00993473|Other Pre-specified|Number of Patients With Different Types of Hypoglycemia Events|Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates.|6 months|Same as for primary endpoint: mITT population.|||participants|||Number
2733650|NCT00993473|Secondary|Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However 1 patient in the NPH group did not have baseline CGM value and 2 other patients (1 in the Lantus group and 1 in the NPH group) did not have on-treatment CGM values.|||mmol/L||Standard Deviation|Mean
2733651|NCT00993473|Secondary|Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit|Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with post-baseline HbA1c values. 2 patients from the Lantus group and 7 from the NPH group had no post-baseline HbA1c value.|||percentage of participants|||Number
2733652|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)|Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate.|baseline, 6 months|Same as for primary endpoint: mITT population.|||percent HbA1c||Standard Error|Least Squares Mean
2733653|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However post-baseline HbA1c values were missing for 9 patients: 2 patients in the Lantus group and 7 in the NPH group.|||percent HbA1c||Standard Deviation|Mean
2733654|NCT00993473|Secondary|Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year|Participants|Standard Deviation|Mean
2733655|NCT00993473|Secondary|Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year||Standard Deviation|Mean
2733656|NCT00993473|Secondary|"Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years"|"Nocturnal hypoglycemia: any event from the all hypoglycemia total that occurred between 23:00 and 07:00 hours."|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year||Standard Deviation|Mean
2733657|NCT00993473|Secondary|Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year|Participants|Standard Deviation|Mean
2733658|NCT00993473|Secondary|Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)|Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries.|6 months|Same as for primary endpoint: mITT population.|||events per patient-year||Standard Deviation|Mean
2733659|NCT00993473|Primary|"Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"The rate of all hypoglycemia was calculated from all hypoglycemia episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times."|6 months|The efficacy population consisted of all randomized patients who received at least one dose of the study medication (modified intent-to-treat [mITT] population). For efficacy analyses, patients were analyzed in the treatment group allocated by the Interactive Voice Response System (IVRS) at randomization (as randomized).|||number of events per patient-year||Standard Deviation|Mean
2733660|NCT00993447|Primary|Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post-each vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
2750334|NCT00874250|Primary|The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment||Treatment through 1 month post treatment||||participants|||Number
2733661|NCT00993447|Primary|Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|"Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).~Flavivirus-naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain."|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2733662|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with < 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2733663|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (pre each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2733664|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2733665|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2733666|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2733667|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.|||Percentage of participants|||Number
2733668|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.|||Percentage of participants|||Number
2733669|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.|||Percentage of participants|||Number
2733684|NCT00993421|Secondary|Change in Total Cholesterol From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2733670|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Percentage of participants|||Number
2733671|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Percentage of Participants|||Number
2733672|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2733673|NCT00993421|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|Analysis of Cmax was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed due to the small sample size.|||nanograms per milliliter (ng/mL)||Standard Error|Geometric Mean
2733674|NCT00993421|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC)|Analysis of AUC was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed because of the low sample size.|||nanograms*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
2733675|NCT00993421|Secondary|Change in Insulin Resistance From Baseline to 24 Weeks Endpoint|Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to inadequate number of samples.|||Units of Insulin/Day||Standard Deviation|Mean
2733676|NCT00993421|Secondary|Change in Fasting Insulin From Baseline to 24 Weeks Endpoint|Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.|||micro Units/milliliter (μU/mL)||Standard Deviation|Mean
2733677|NCT00993421|Secondary|Change in Fasting Glucose From Baseline to 24 Weeks Endpoint|Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2733678|NCT00993421|Secondary|Change in Glycated Hemoglobin A1c (HbA1c) From Baseline|Analysis of change in HbA1c was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to the small sample size.|||percent glycated hemoglobin||Standard Deviation|Mean
2733679|NCT00993421|Secondary|Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale|Vitality change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body mass index was used as covariate. SF-36 is a self-reported questionnaire that consists of 36 questions covering 8 health domains including vitality. The vitality domain results are presented. The vitality domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2733680|NCT00993421|Secondary|Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)|Results presented as Least Squares Mean with treatment, visit, and their interaction as fixed effects, subject as random effect, baseline body mass index used as covariate. OWL-QoL consists of 17 items on scale ranging from 0 (Not at all) to 6 (A very great deal). Before calculating scores, each item is reversed. A single quality of life score is computed by summing each item and transforming this raw score onto standardized scale of 0 (greatest impact) to 100 (lowest impact) using formula: score = [(sum of component items score (minus) lowest possible score/ possible raw score range)*100].|Baseline, 24 weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
2733681|NCT00993421|Secondary|Change in Triglycerides From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2733682|NCT00993421|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2733683|NCT00993421|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2740893|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||participants|||Number
2733686|NCT00993421|Secondary|Change in Waist Circumference From Baseline to 24 Week Endpoint|Change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||centimeter (cm)||Standard Error|Least Squares Mean
2733687|NCT00993421|Secondary|Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint|Change in body composition (lean body mass and fat mass) was assessed using dual energy x-ray absorptiometry (DXA) and is presented as LSMEAN values with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body composition, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||kilograms (kg)||Standard Error|Least Squares Mean
2733688|NCT00993421|Secondary|Change in Blood Pressure From Baseline to 24 Week Endpoint|Blood pressure change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline blood pressure, age, gender were used as covariates.|Baseline, 24 weeks|ITT|||mm Hg||Standard Error|Least Squares Mean
2733689|NCT00993421|Secondary|Change in Heart Rate From Baseline to 24 Week Endpoint|Heart rate change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline heart rate, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2733690|NCT00993421|Secondary|Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks||24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||percentage of participants|||Number
2733691|NCT00993421|Secondary|The Mean Change in Body Weight From Baseline to 24 Week Endpoint|Body weight change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||kilograms||Standard Error|Least Squares Mean
2733692|NCT00993421|Primary|Percent Change in Body Weight From Baseline to 24 Week Endpoint|Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||percent change||Standard Error|Least Squares Mean
2733693|NCT00993317|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.|Baseline and Week 24|FAS population|||scores on a scale||Standard Deviation|Mean
2733694|NCT00993317|Secondary|ACR70 Responses at Week24||Week 24|FAS population|||participants|||Number
2733695|NCT00993317|Secondary|ACR50 Responses at Week 24||Week 24|FAS population|||participants|||Number
2733696|NCT00993317|Secondary|ACR70 Responses at Week 12|Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week12|FAS population|||participants|||Number
2733697|NCT00993317|Secondary|ACR50 Responses at Week 12|Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population|||participants|||Number
2733698|NCT00993317|Secondary|ACR 20 Responses at Week 12|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population|||participants|||Number
2733699|NCT00993317|Primary|ACR20 Responses at Week 24|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 24|Full Analysis Set (FAS) Population The full set population will consist of all the subjects who were randomized and treated with the drug and received the primary efficacy evaluation at baseline. In the case of dosing administration error, analyses on the FAS population will be conducted according to the drug the subjects were randomized to.|||participants|||Number
2733700|NCT00993291|Secondary|Time to Walk 14 Meters|Change in the time to walk 14 meters compared to baseline measured in seconds|5 hours|||||||
2733701|NCT00993291|Secondary|Gait Velocity|gait velocity measured as change from baseline in in CM/second|5 hours|||||||
2733702|NCT00993291|Primary|Change in Stride Length From Baseline|Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length|1 hour||||CM||Full Range|Mean
2733703|NCT00993265|Secondary|National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)|The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment.|Week 12||||units on a scale||Standard Error|Mean
2733704|NCT00993265|Secondary|The Milwaukee Inventory for Styles of Trichotillomania-Child Version|"The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses focused pulling, hair pulling that occurs intentionally to relieve tension or distress, and automatic pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the focused pulling subscale and 4 questions in the automatic pulling subscale. The scores range from 0-36 on the automatic pulling subscale and 0-189 on the focused pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style."|Week 12||||units on a scale||Standard Error|Mean
2733705|NCT00993265|Secondary|Trichotillomania Scale for Children - Parent Version|The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12||||units on a scale||Standard Error|Mean
2733706|NCT00993265|Secondary|Children's Depression Inventory|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12||||units on a scale||Standard Error|Mean
2733707|NCT00993265|Secondary|Multidimensional Anxiety Scale for Children (MASC)|The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.|Week 12||||units on a scale||Standard Error|Mean
2733708|NCT00993265|Secondary|Trichotillomania Scale for Children - Child Version|The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12||||units on a scale||Standard Error|Mean
2733709|NCT00993265|Primary|Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12||||units on a scale||Standard Error|Mean
2733710|NCT00993200|Secondary|Thrombotic Complication|Number of thrombotic events|12 week||||number of thrombotic events|||Number
2733711|NCT00993200|Secondary|Adverse Major and Minor Bleeding Events|Number of major and minor bleeding events|12 week||||number of bleeding events|||Number
2733712|NCT00993200|Primary|The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range|The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.|variable as defined|analysis per protocol|||days||Standard Deviation|Median
2733713|NCT00993187|Secondary|Percentage of Participants With HbA1C < 7.0% at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).|Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.|||Percentage of Participants|||Number
2733714|NCT00993187|Secondary|Change From Baseline in Body Weight at Week 30|Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)|Baseline and Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.|||kg||95% Confidence Interval|Least Squares Mean
2733715|NCT00993187|Secondary|Percentage of Participants With One or More Episodes of Hypoglycemia|Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.|Up to Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.|||Percentage of participants|||Number
2733716|NCT00993187|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).|Baseline and Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2733717|NCT00993187|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 30 weeks|The APaT Population includes all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2733718|NCT00993187|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 32 weeks|The All Patients as Treated (APaT) Population includes all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2733719|NCT00993187|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).|Baseline and Week 30|Full-Analysis-Set (FAS) Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.|||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
2733720|NCT00993148|Secondary|Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL|Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|96 weeks||||percentage of participants||95% Confidence Interval|Number
2733721|NCT00993148|Secondary|Median CD4 Count Change From Baseline|Median changes from baseline in peripheral CD4+ T-cell count|96 weeks||||cells per mm^3||Inter-Quartile Range|Median
2733722|NCT00993148|Secondary|Trough Concentrations (Ctrough) of Maraviroc|Average trough concentration (Ctrough) of maraviroc|24 hours||||ng/mL||Standard Deviation|Mean
2733723|NCT00993148|Secondary|Drug Adherence, Number of Participants With Missed Doses|Drug adherence, assessed as number of participants with missed doses over four-day recall|Week 24||||participants|||Number
2733724|NCT00993148|Secondary|Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES||At study entry and at the time of virologic failure||||participants|||Number
2733725|NCT00993148|Secondary|Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher|Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen|96 weeks||||participants|||Number
2733726|NCT00993148|Secondary|Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL|Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|48 weeks||||percentage of participants||95% Confidence Interval|Number
2733727|NCT00993148|Secondary|Percentage of Participants With Virologic Failure or Off Study Treatment Regimen|Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)|24 weeks||||percentage of participants||95% Confidence Interval|Number
2733728|NCT00993148|Primary|Percentage of Participants With Plasma HIV-1 RNA >50|Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL|24 weeks||||percentage of participants||95% Confidence Interval|Number
2733729|NCT00993044|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity events|2 years||||participants|||Number
2733730|NCT00993031|Secondary|Number of Participants With Grade 3 or 4 Toxicity in the Two Treatment Groups in Women||Randomization to one month postpartum||||Participants|||Count of Participants
2733731|NCT00993031|Secondary|ART Levels in Hair Samples at Delivery|antiretroviral hair concentrations (per doubling)|delivery|Note: The above numbers differ from the numbers of participants who delivered according to the Patient Flow Overview (187 and 190, respectively) due to the fact that a small number participants chose to decline this optional measurement.|||antiretroviral hair concentration(ng/mg)||Full Range|Mean
2733732|NCT00993031|Secondary|Number of Participants With Maternal to Child Transmission of HIV, Measured by Infant HIV DNA PCR|HIV tested by DNA PCR|Delivery to 48 weeks postpartum||||Participants|||Count of Participants
2733733|NCT00993031|Secondary|Change in Maternal CD4 Cell Counts|CD4 cell count recovery efavirenz at delivery|Time of randomization to delivery, an average of 20 weeks||||CD4 cell count||Standard Deviation|Median
2733734|NCT00993031|Secondary|Number of Participants With Maternal HIV RNA Suppression of <400 Copies/mL|Virologic suppression was defined as plasma HIV-1 RNA 400 copies/ml or less based on the lower limit of detection of the available test.|Time from randomization until delivery, an average of 20 weeks|Note: The above numbers differ from the numbers of participants who delivered according to the Patient Flow Overview (187 and 190, respectively) due to the inability to measure HIV RNA a small number of women at delivery, for technical or logistical reasons.|||Participants|||Count of Participants
2733735|NCT00993031|Secondary|Incidence of Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick|Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick|Time from randomization until delivery||||Participants|||Count of Participants
2733736|NCT00993031|Secondary|Number of Participants With Severe Maternal Anemia Defined by Hemoglobin < 8g/dl at Any Point During the Trial in Each Treatment Group|Proportion of women with severe maternal Anemia (hemoglobin < 8g/dl by hemacue or CBC) at any point during the trial in Each Treatment Group|Time from randomization until one year follow up||||Participants|||Count of Participants
2733737|NCT00993031|Secondary|Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk After Pregnancy||Number of treatments given for clinical malaria based on postive blood smear from time from delivery until 24 months after delivery or cessation of breastfeeding||||treatments|||Number
2733738|NCT00993031|Secondary|Placental Malaria Defined Placental Histopathologic Analysis|Number of participants with positive placental histopathology slide for malaria|Delivery||||participants|||Number
2733739|NCT00993031|Secondary|Prevalence of Composite Clinical Outcome Defined by LBW, Stillbirth(Intrauterine Fetal Demise >20wks GA), Late Spontaneous Abortion(Miscarriage 12-20wks GA), Preterm Delivery(<37wks Gestation), Neonatal Death(Death of Liveborn Infant Within First 28days)|Percent of evaluated participants with composite clinical outcome defined by LBW, stillbirth (intrauterine fetal demise >20wks GA), late spontaneous abortion(miscarriage 12-20wks GA), preterm delivery(<37wks gestation), neonatal death(death of live-born infant within first 28 days)|Time from randomization until 24 months postpartum or cessation of breastfeeding||||% of evaluated participants with outcome|||Number
2733740|NCT00993031|Secondary|Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk During Pregnancy||Number of treatments given for clinical malaria based on postive blood smear from time from randomization until 24 months after delivery or cessation of breastfeeding||||treatments|||Number
2733777|NCT00992784|Secondary|HI Antibody Seroconversion Factors (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||fold change||95% Confidence Interval|Geometric Mean
2733741|NCT00993031|Secondary|Placental Malaria Defined as Positive Placental RDT|Number of participants with positive placental RDT for malaria. Malaria rapid diagnostic tests (RDTs) assist in the diagnosis of malaria by detecting evidence of malaria parasites (antigens) in human blood. RDTs permit a reliable detection of malaria infections particularly in remote areas with limited access to good quality microscopy services.|Delivery|Some participants did not have a placental specimen taken at delivery in the hospital (e.g. deliveries that occurred at home, missed by staff error, etc)|||participants|||Number
2733742|NCT00993031|Primary|Prevalence of Malaria Defined as Positive Placental Blood PCR|Number of participants with positive placental blood PCR for malaria|Delivery|Placental blood PCR|||participants|||Number
2733743|NCT00993031|Primary|Prevalence of Malaria Defined as Positive Placental Blood Smear|Number of participants with positive placental blood smear for malaria|Delivery|Placental blood smear|||participants|||Number
2733744|NCT00992992|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment to the date of death from any cause.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Months||95% Confidence Interval|Median
2733745|NCT00992992|Secondary|Number of Participants With an Adverse Event of Cytopenia|The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Participants|||Number
2733746|NCT00992992|Secondary|Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).|Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months)|ITT-Exposed Population. Only those participants evaluable for HAMA were analyzed.|||Participants|||Number
2733747|NCT00992992|Secondary|Time to Recovery From the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.|||Days||95% Confidence Interval|Median
2733748|NCT00992992|Secondary|Time to Nadir for the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.|||Days||Standard Deviation|Mean
2733749|NCT00992992|Secondary|Mean Nadir Values for Platelets and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had platelet and WBC data available.|||1000 cells/microliter||Standard Deviation|Mean
2733750|NCT00992992|Secondary|Mean Nadir Value for Hemoglobin|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had hemoglobin data available.|||grams/deciliter (g/dL)||Standard Deviation|Mean
2733751|NCT00992992|Secondary|Mean Nadir Value for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights infection.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had ANC data available.|||1000 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
2733752|NCT00992992|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Participants|||Number
2733753|NCT00992992|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Months||95% Confidence Interval|Median
2733754|NCT00992992|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Months||95% Confidence Interval|Median
2733755|NCT00992992|Secondary|Duration of Response for Confirmed Complete Responders|Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with confirmed CR were analyzed.|||Months||95% Confidence Interval|Median
2733756|NCT00992992|Secondary|Duration of Response for Unconfirmed Complete Responders|Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with unconfirmed CR were analyzed.|||Months||95% Confidence Interval|Median
2733757|NCT00992992|Secondary|Duration of Response for All Unconfirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with an unconfirmed response (CR, CRu, or PR) were analyzed for duration of response.|||Months||95% Confidence Interval|Median
2733758|NCT00992992|Secondary|Duration of Response for All Confirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants (par.) with a confirmed CR, CRu, or PR were analyzed. The number of par. analyzed represents the par. with a confimed CR, CRu, or PR who also had the same response or a better response as confirmation (for example, a par. with an initial CRu and a subsequent CR has been included in the analysis).|||Months||95% Confidence Interval|Median
2733759|NCT00992992|Secondary|Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)|A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants evaluable for response (those with at least one response assessment) were analyzed.|||Participants|||Number
2733760|NCT00992992|Primary|Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)|Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 centimeters [cm] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population: all participants who received any iodine I-131 tositumomab or CHOP treatment. Only those participants evaluable for response (those with at least one response assessment) were analyzed.|||Participants|||Number
2733761|NCT00992927|Secondary|Pain Measured by Visual Analogue Scale (VAS)|"before intervention for all participants~using 10cm horizontal visual analog scale~best: 0cm (no pain)~worst: 10cm (worst pain)"|1 month||||cm||Standard Deviation|Mean
2733762|NCT00992927|Primary|Range of Motion (ROM) of the Glenohumeral Joint|"before intervention for all participants~using a goniometer~patient sitting on a stool with the arm at anatomical position~worst: 0 degree~best: 360 degree"|1 month||||degree||Standard Deviation|Mean
2733763|NCT00992836|Secondary|Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens|"The TIV assay was not performed due to lack of available cells after completion of other planned assays.~The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10^6 peripheral blood mononucleated cell (PBMC).~The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10^6 PBMC.~The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10^6 PBMC."|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||SFC/10^6 PBMC||Inter-Quartile Range|Median
2751680|NCT00862940|Secondary|Changes in Total Hippocampal Volume (HCV)|Estimated mean changes in total HCV|Baseline to 1 year|FAS-MRI|||mm^3/year||Standard Deviation|Mean
2733764|NCT00992836|Secondary|HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||titer||Inter-Quartile Range|Median
2733765|NCT00992836|Secondary|Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
2733766|NCT00992836|Secondary|Geometric Mean Antibody Titers (GMT) HAI|Presents the value of the geometric mean titer at each time point.|Measured after first and second doses and 6 months after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.|||titers||95% Confidence Interval|Geometric Mean
2733767|NCT00992836|Secondary|Percent of Participants With an HAI Titer >=40 at Long-term Follow-up||Measured at 6 months after second dose|The HAI titers were summarized for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.|||percentage of participants||95% Confidence Interval|Number
2733768|NCT00992836|Primary|Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and 10 days after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.|||percentage of participants||95% Confidence Interval|Number
2733769|NCT00992836|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|The 154 study participants who received at last one vaccination are included in this analysis.|||participants|||Number
2733770|NCT00992836|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 7 months after vaccination|The 154 study participants who received at last one vaccination are included in this analysis.|||participants|||Number
2733771|NCT00992836|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|"Shows the number of participants who had at least one adverse event (AE) in each category. The AEs include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs.~Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death."|Measured up to 7 months after vaccination||||participants|||Number
2733772|NCT00992784|Secondary|The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180|The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 180 in subjects for whom data concerning immunogenicity were available for at least one test, 180 Days after vaccination.|||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
2733773|NCT00992784|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 21 in subjects for whom data concerning immunogenicity were available for at least one test, 21Days after vaccination.|||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
2733774|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||Participants|||Count of Participants
2733775|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||Participants|||Count of Participants
2733776|NCT00992784|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||fold change||95% Confidence Interval|Geometric Mean
2734382|NCT00988533|Secondary|Number of Participants Reporting Adverse Events Following Ivermectin Treatment|Adverse events were assessed at each visit and during the follow up phone call on Day 28.|Day 1 up Day 28 post-application|Adverse events were assessed in the intent-to-treat population.|||Participants|||Number
2733778|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||Participants|||Count of Participants
2733779|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||Participants|||Count of Participants
2733780|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||Participants|||Count of Participants
2733781|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||Participants|||Count of Participants
2733782|NCT00992784|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||titer||95% Confidence Interval|Geometric Mean
2733783|NCT00992784|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||titer||95% Confidence Interval|Geometric Mean
2733784|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|After Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733785|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Up to Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733786|NCT00992784|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733787|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733788|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2733789|NCT00992784|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Days||Full Range|Median
2733790|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2733792|NCT00992784|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2733793|NCT00992719|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to and at Day 21 post vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 21 following vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||participants|||Number
2733794|NCT00992719|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination as well as 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||participants|||Number
2733795|NCT00992719|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post vaccination|All participants receiving the vaccination and who reported temperatures are included in the safety cohort. One participant did not report temperatures. Analyses are as treated.|||participants|||Number
2733796|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
2733797|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.|||participants|||Number
2733798|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.|||participants|||Number
2733799|NCT00992719|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
2733800|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
2733801|NCT00992719|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
2743458|NCT00928018|Secondary|To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms||6 months||||percentage of participants|||Number
2733802|NCT00992719|Primary|Number of Births With Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.|||births|||Number
2733803|NCT00992719|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.|||participants|||Number
2733804|NCT00992602|Secondary|Overall Survival||Time from start of therapy until death, assessed up to 4 years||||months||95% Confidence Interval|Median
2733805|NCT00992602|Primary|Survival Free of Neurological Progression, Measured in Weeks|Neurological progression defined by either clinical impression (measured by Karnofsky Performance Status), radiographical response (using Macdonald criteria), or cytologic response (measured by CSF cytology).|Time from start of therapy, assessed up to 4 years||||weeks||95% Confidence Interval|Median
2733806|NCT00992589|Primary|Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2733807|NCT00992589|Primary|Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2733808|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2733809|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2733810|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2733811|NCT00992589|Secondary|The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||number of episodes||Standard Deviation|Mean
2733812|NCT00992589|Primary|Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)|Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant's age and gender (Borghi E, 2006).|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||Z-score||Standard Deviation|Mean
2733813|NCT00992589|Primary|Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||frequency of Regurgitation||Standard Deviation|Mean
2733814|NCT00992511|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2733815|NCT00992511|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2733816|NCT00992511|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Related pIMD was defined as an event assessed by the investigator as possibly related to the study vaccination.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2733817|NCT00992511|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and overall|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Days||Inter-Quartile Range|Median
2733818|NCT00992511|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2733819|NCT00992511|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and overall|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Days||Inter-Quartile Range|Median
2733820|NCT00992511|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2733821|NCT00992511|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 182 and 364|The ATP cohort for antibody persistence at Day 182 and 364 included all evaluable subjects for whom one or two doses were taken and for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Day 182 and 364|||Fold increase||95% Confidence Interval|Geometric Mean
2733822|NCT00992511|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21 and 42|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
2733823|NCT00992511|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 182 and 364|The ATP cohort for antibody persistence at Day 182 and 364 included all evaluable subjects for whom one or two doses were taken and for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Day 182 and 364|||Participants|||Count of Participants
2733824|NCT00992511|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2733825|NCT00992511|Secondary|Number of SCR Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The ATP cohort for antibody persistence at Day 182 and 364 included all evaluable subjects for whom one or two doses were taken and for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Day 182 and 364|||Participants|||Count of Participants
2733826|NCT00992511|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 21 and 42|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2733827|NCT00992511|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 182 and 364|The ATP cohort for antibody persistence at Day 182 and 364 included all evaluable subjects for whom one or two doses were taken and for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Day 182 and 364|||Titers||95% Confidence Interval|Geometric Mean
2733828|NCT00992511|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.|At Days 182 and 364|The ATP cohort for antibody persistence at Day 182 and 364 included all evaluable subjects for whom one or two doses were taken and for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Day 182 and 364|||Participants|||Count of Participants
2733829|NCT00992511|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 42|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Titer||95% Confidence Interval|Geometric Mean
2733830|NCT00992511|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 0 and 42|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2733831|NCT00992511|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 21|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2733832|NCT00992511|Primary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.|At Day 21|The According-to Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom one or two doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2733833|NCT00992459|Secondary|U-PAGN24-hour Excr of NaPBA and HPN-100||24 hours on Day 14 of each treatments|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg||Standard Deviation|Mean
2733834|NCT00992459|Secondary|Cmax PAGN of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg/mL||Standard Deviation|Mean
2733835|NCT00992459|Secondary|Cmax for PBA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg/mL||Standard Deviation|Mean
2733836|NCT00992459|Secondary|Cmax for PAA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg/mL||Standard Deviation|Mean
2733837|NCT00992459|Secondary|Rate of Adverse Events in Each Treatment Group||29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.|||participants|||Number
2733838|NCT00992459|Secondary|Number and Severity of Symptomatic Hyperammonemic Crises|Severity of symptomatic hyperammonemic crises was measured by peak ammonia level (µmol/L) when it is >= 100 µmol/L.|29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.|||events|||Number
2733839|NCT00992459|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA Versus HPN-100|NaPBA treated arm: total 345 blood samples were collected. HPN-100 treated arm: 343 blood samples were collected.|on Day 14 and Day 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||samples|blood samples||Number
2733840|NCT00992459|Secondary|Maximum Ammonia Values Observed on NaPBA Versus HPN-100|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||µmol/L||Standard Deviation|Mean
2733841|NCT00992459|Secondary|Correlation Between Urinary Phenylacetylglutamine (PAGN) Excretion Over 24 Hours (U-PAGN24-hour Excr) and Venous Ammonia - Area Under the Concentration-time Curve From Time 0 (Predose) to 24 Hours (AUC0-24)|The correlation between 24-hour urinary phenylacetylglutamine (PAGN) excretion (U-PAGN24-hour Excr) and venous ammonia AUC0-24 was summarized and the correlation was tested using the Spearman rank-order correlation.|28 Days|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||correlation coefficient|||Number
2733842|NCT00992459|Primary|The Primary Endpoint Was the 24-hour Area Under the Curve for Blood Ammonia (NH324-hour AUC) on Days 14 and 28.|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. Arm A day 14 and Arm B day 28 data were combined as a NaPBA treatment Arm. Arm B day 14 and Arm A day 28 data were combined as a HPN-100 treatment Arm.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μmol∙h/L||Standard Deviation|Mean
2733843|NCT00992446|Secondary|Event-free Survival|Number of patients alive without disease progression/relapse|6.64 Years Post-Transplant||||Participants|||Count of Participants
2733844|NCT00992446|Secondary|Overall Survival|Number of patients alive who received maintenance therapy|6.64 Years Post-Transplant||||participants|||Number
2733845|NCT00992446|Secondary|Ability to Complete Planned 12 Cycles of Maintenance Therapy|Number of patients who completed all 12 cycles of maintenance therapy.|Approximately 12 months following start of maintenance therapy||||Participants|||Count of Participants
2733846|NCT00992446|Secondary|Median Time to Disease Progression|median days from transplant to relapse/progression|time post ASCT to progression|median time to progression /relapse|||years||Full Range|Median
2733847|NCT00992446|Primary|Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant|Number of patients on maintenance therapy post-transplant who experienced grade 3 or higher toxicity per NCI-Common Terminology Criteria for Adverse Events, version 3. The first three months of bortezomib and vorinostat therapy will be used as the time period to evaluate toxicity for stopping rules of the study. Toxicity that meets stopping rules will be determined based on the number of patients that are withdrawn from study for significant toxicity (grade IV, non-hematological, non-metabolic, non-peripheral neuropathy).|3 months after start of maintenance therapy||||Participants|||Count of Participants
2733848|NCT00992433|Primary|Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2733849|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2733850|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2733851|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2733852|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2733853|NCT00992433|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2733854|NCT00992433|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. One participant did not record temperatures. Analyses are as treated.|||Participants|||Number
2733855|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2733856|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2733857|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733858|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 and Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733859|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733860|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733861|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733862|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733863|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733864|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733865|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733866|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733867|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733868|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733869|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733870|NCT00992433|Primary|Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733871|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733872|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733873|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733874|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733929|NCT00992186|Secondary|Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)||Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.|||mcg*day/mL||Standard Deviation|Mean
2733875|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733876|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
2733877|NCT00992407|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52|The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Units on a scale||Standard Deviation|Mean
2733878|NCT00992407|Secondary|Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52|The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Full Range|Median
2733879|NCT00992407|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52|The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Full Range|Median
2733880|NCT00992407|Secondary|Change From Baseline in Number of Outpatient Clinic Visits at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||number of visits||Standard Deviation|Mean
2733881|NCT00992407|Secondary|Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Won||Standard Deviation|Mean
2733882|NCT00992407|Secondary|Change From Baseline in Total Outpatients and Inpatients Hours at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||hours||Standard Deviation|Mean
2739122|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day post drug administration 2||||score on a scale||Standard Error|Mean
2733883|NCT00992407|Secondary|Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||days||Standard Deviation|Mean
2733884|NCT00992407|Secondary|Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||participants||Standard Deviation|Mean
2733885|NCT00992407|Secondary|Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733886|NCT00992407|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52|The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733887|NCT00992407|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733888|NCT00992407|Secondary|Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52|Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733889|NCT00992407|Secondary|Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52|The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733890|NCT00992407|Secondary|Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Errors||Standard Deviation|Mean
2733891|NCT00992407|Secondary|Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Words||Standard Deviation|Mean
2733892|NCT00992407|Secondary|Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Seconds||Standard Deviation|Mean
2733893|NCT00992407|Secondary|Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Correct responses||Standard Deviation|Mean
2733894|NCT00992407|Secondary|Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52|For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733895|NCT00992407|Secondary|Change From Baseline in Social Functioning Scale (SFS) Score at Week 52|Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2733896|NCT00992407|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
2733897|NCT00992407|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
2733930|NCT00992186|Secondary|Maximum Observed Serum Concentration (Cmax)|The maximum observed analyte concentration was measured.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab.|||mcg/mL||Standard Deviation|Mean
2752220|NCT00858689|Primary|ABC Irritability Subtest Score|ABC Irritability subtest score was used|8 weeks|completed 8 weeks of minocycline treatment|||units on a scale||Standard Deviation|Mean
2733898|NCT00992407|Primary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52|The PSP assesses degree of participant's dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline and Week 52|Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
2733899|NCT00992394|Secondary|Physician Global Assessment (PGA) of Disease Activity at Week 52|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Week 52|The modified intent-to-treat (mITT) population will be the primary efficacy population and will correspond to all randomized subjects who have a baseline PGA and at least one postbaseline PGA.|||Units on a scale||Standard Deviation|Mean
2733900|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733901|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733902|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733903|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733904|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733905|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733906|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733931|NCT00992186|Secondary|Minimum Observed Serum Concentration (Cmin)||Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
2743459|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms||2 years||||percentage of participants||95% Confidence Interval|Number
2733907|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733908|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733909|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733910|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733911|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733912|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733913|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733914|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
2733915|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of participants|||Number
2733916|NCT00992394|Secondary|Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Units on a scale||Standard Deviation|Mean
2741865|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose|Average FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h||||L||Standard Deviation|Mean
2733917|NCT00992394|Primary|Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52|"PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and Almost clear' includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks*7days + 1."|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2733918|NCT00992264|Primary|Treatment Utilization for Smoking Cessation|confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program|12 months|Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.|||% of participants using adjunct treatmen|||Number
2733919|NCT00992264|Primary|Smoking Abstinence|7 day point prevalent abstinence|12 months|Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.|||percentage of abstinent participants|||Number
2733920|NCT00992225|Secondary|Maximum Concentration (Cmax)||After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]|All participants who received at least one dose of the study drug.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2733921|NCT00992225|Secondary|The Percentage of Participants With Exposures in the Target Range|Exposure is the amount of drug the body sees in a period of time. Target range is an exposure thought to offer the optimal balance of safety and efficacy based on prior research.|After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)|All participants who received at least one dose of the study drug.|||Percentage of participants|||Number
2733922|NCT00992225|Secondary|Duration of Stable Disease|Duration of stable disease (SD) is defined from date of documented SD to first date of progressive disease (PD) or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months|All participants who received at least one dose of the study drug.|||months||90% Confidence Interval|Median
2733923|NCT00992225|Secondary|Duration of Overall Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to RECIST guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to progressive disease or death up to 12 months|Zero participants analyzed. Duration of Overall Response for CR and PR data was not collected for analysis.||||||
2733924|NCT00992225|Secondary|Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]|Clinical Benefit Rate = [(CR) + (PR) + Stable Disease (SD)] of at least 4 cycles/N as classified by the investigator according to the RECIST guidelines, where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|Baseline to measured progressive disease or death from any cause up to 12 months|All participants who received at least one dose of the study drug.|||percentage of participants||90% Confidence Interval|Number
2733925|NCT00992225|Secondary|Progression-free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to measured progressive disease or death from any cause up to 12 months|All participants who received at least 1 dose of the study drug.|||months||90% Confidence Interval|Median
2733926|NCT00992225|Primary|Percentage of Participants With an Objective Overall Response|Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease or death from any cause up to 12 months|All participants who received at least one dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2733927|NCT00992186|Other Pre-specified|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score|A worsening in ECOG performance status score was defined as greater than or equal to 1-point increase from Baseline. Time to worsening is defined as the number of days from first dose to the first day of worsening in ECOG score, or death, whichever occurred first. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all selfcare, 3=Capable of limited selfcare, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no selfcare, totally confined to bed or chair, 5=Dead.|Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.|||Days||95% Confidence Interval|Median
2733928|NCT00992186|Secondary|Half-life (t1/2)|The time measured for the serum concentration to decrease by one half.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.|||Days||Full Range|Median
2734588|NCT00986986|Secondary|High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12|"HDL, often referred to Good cholesterol levels, will be obtained in both arms. HDL is a marker of coronary heart disease."|Two time points (baseline and study week 12)||||mg/dl||Inter-Quartile Range|Median
2733932|NCT00992186|Secondary|Duration of Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.||||||
2733933|NCT00992186|Secondary|Time to Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.||||||
2733934|NCT00992186|Secondary|Percentage of Participants With Pain Response|Pain response is defined as 2-point decrease from Baseline in 'worst pain' intensity score (item 3) on the Brief Pain Inventory (BPI) questionnaire. The BPI is a nine-item questionnaire with 0 to 10 numeric rating scales in response to each item, where 0=No pain and 10=Pain as bad as you can imagine. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab, had Baseline BPI ‘worst pain’ intensity score (item 3) more than or equal to 2, and at least 1 post-treatment pain evaluation. Participants with disease progression were considered to be evaluable, regardless of the post-dose evaluation.|||Percentage of participants|||Number
2733935|NCT00992186|Secondary|Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response|Urinary NTx response for participants with elevated NTx level at Baseline (more than or equal to 50 nanomole per millimole (nmol/mmol)) is defined as a 30% reduction from Baseline NTx value, confirmed by a second NTx value 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had elevated urinary NTx level at Baseline (more than or equal to 50 nmol/mmol) and at least 1 post-treatment urinary NTx measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2733936|NCT00992186|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response for participants with elevated PSA levels at Baseline (more than or equal to 5 nanogram per milliliter (ng/mL) is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value measurement 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a Baseline PSA more than or equal to 5 ng/mL and at least 1 post-treatment PSA measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2733937|NCT00992186|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of initiation of study treatment to death due to any cause. Participants were followed for 1 year after the last administration of carlumab for survival or until the end of study, whichever occurs first. For participants with unknown survival status as of the data cutoff date, OS was censored at the last date that the participant was known to be alive.|Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.|||Days||Full Range|Median
2733938|NCT00992186|Secondary|Progression-Free Survival (PFS)|The PFS is defined as the time from the date of initiation of study treatment to the date of initial documented skeletal or extra-skeletal progressive disease, or date of death, whichever occurs first. A participant is considered to have extra-skeletal disease progression if the disease has progressed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria. A participant is considered to have skeletal disease progression if they have 1 post-baseline bone scan demonstrating 2 or more new skeletal lesions compared to Baseline and confirmed by a second bone scan 6 to 12 weeks later or with evidence of clinical progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.|||Days||95% Confidence Interval|Median
2733939|NCT00992186|Secondary|Percentage of Participants With Objective Tumor Response|Objective response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a measurable, non-measurable or bone lesion at Baseline and had at least 1 post-treatment tumor evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2733969|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733970|NCT00991939|Primary|The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.||From 60 days through 365 days after study entry.||||percentage of subjects|||Number
2733940|NCT00992186|Primary|Percentage of Participants With Composite Response|The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had at least 1 post-baseline disease evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2733941|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening|maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)|baseline, 4 months|Participants completing the 4-month follow-up|||participants|||Number
2733942|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold|measurements were obtained by placing examiner's index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).|baseline, 4 months|Participants completing the 4-month follow-up|||participants|||Number
2733943|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|6 weeks||||participants|||Number
2733944|NCT00992108|Primary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|4 months|participants who completed the 4-month follow-up|||participants|||Number
2733945|NCT00992056|Primary|Change in 24-hour Mean Systolic Blood Pressure by ABPM From Day 5 of Low Sodium to Day 10 of High Sodium||Day 5, Day 10|24 subjects were randomized. Three withdrew informed consent during the study. One was withdrawn during the washout period. One completed all phases of the study but had a faulty ABPM reading on the last determination|||mmHg||95% Confidence Interval|Mean
2733946|NCT00992017|Secondary|Response to Seasonal Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry|Pregnant women who received the first H1N1 immunization.|||titer||Inter-Quartile Range|Median
2733947|NCT00992017|Secondary|Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 PBMC and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose|The pregnant women who had not delivered prior to the evaluation, had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
2733948|NCT00992017|Secondary|Infant GMT of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at birth and at 3 and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.|||units on the HAI titer scale||95% Confidence Interval|Geometric Mean
2733949|NCT00992017|Secondary|Maternal Geometric Mean Titers (GMT) of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery|The population consists of eligible women with nonmissing HAI titers, who had not delivered before the evaluation post first or second dose, and received all vaccines up to that point, respectively. The N for analyses after the first and second vaccinations, at delivery, 3 and 6 months after were 104, 94, 102, 92 and 58, respectively.|||titers||95% Confidence Interval|Geometric Mean
2733950|NCT00992017|Secondary|Percent of Infants With an HAI Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at birth (via cord blood) and at 3 months and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.|||Percent of participants||95% Confidence Interval|Number
2733971|NCT00991887|Primary|Mayo Elbow Performance Score|Mayo Elbow Performance Score (MEPS) is an outcome tool based on a 100 point scale, with higher score indicating better function. It measures pain, stability, function, and motion. The score is graded on the basis of the MEPS as excellent (>=90), good (75-89), fair (60-74), and poor (<60).|6 month|Patients with elbow trauma treated with radiation therapy in the prevention of post-traumatic heterotopic ossification. Subjects are randomized to either radiation therapy or no radiation therapy.|||units on a scale||Standard Deviation|Mean
2733951|NCT00992017|Secondary|Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at delivery of the baby, and at 3 months and 6 months after delivery|The population consists of eligible pregnant women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for the analyses of HAI titers at delivery, and at 3 and 6 months after were 102, 92 and 58, respectively. Only some women had a clinic visit at 6 months post delivery.|||Percent of participants||95% Confidence Interval|Number
2733952|NCT00992017|Primary|Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and at 10 days after second dose of study vaccine|The analysis population consists of the eligible pregnant women with nonmissing HAI titers, who had not delivered prior to the evaluation, and had received all doses of vaccine up to that timepoint. The N for the analyses of HAI titers after the first and second vaccinations were 118 and 108, respectively.|||Percent of participants||95% Confidence Interval|Number
2733953|NCT00992017|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|All 128 pregnant women who received at least one vaccination are included.|||Participants|||Number
2733954|NCT00992017|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included.|||Participants|||Number
2733955|NCT00992017|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included in this analysis.|||Participants|||Number
2733956|NCT00991952|Primary|Overall Response Rate|Response was determined as indicated in the protocol.|From the start of treatment for up to 3 months||||participants|||Number
2733957|NCT00991939|Secondary|The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy||Through 1 year after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733958|NCT00991939|Secondary|The Percentage of Patients Not Completing Study Therapy||49 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733959|NCT00991939|Secondary|The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733960|NCT00991939|Secondary|Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey||Weeks 4, 8, and 52 after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733961|NCT00991939|Secondary|The Percentage of Patients Undergoing Splenectomy||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733962|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733963|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733964|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733965|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry||Through 60 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733966|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733967|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2733968|NCT00991939|Secondary|The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365||365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
2741866|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h||||L||Standard Deviation|Mean
2733972|NCT00991809|Secondary|Pain Threshold|The amount of time (in seconds) before the participant first verbally reports feeling pain after placing hand in 4 degree Celsius circulating water bath at the 30 minute time point. Truncated at 300 seconds for safety purposes.|8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.|||seconds||Full Range|Mean
2733973|NCT00991809|Primary|Pain Tolerance|The participant places their hand in a water bath kept at 4 degrees Celsius (cold pressor test). They then continue to hold the hand in the water bath until they can no longer tolerate the pain (pain tolerance) or until the end of the testing (truncated at 300 seconds for safety purposes). Reported as the mean (time to hand removal in seconds) at the 30 minute time point.|8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.|||seconds||Full Range|Mean
2733974|NCT00991510|Secondary|Summary of Participants With Adverse Events|"Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator.~The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.~Severity was measured on a three-point scale: mild, moderate, severe."|Day 1 up to Day 112|Safety population. One participant discontinued the study prior to Period II so the Myfenax # participants analyzed is one less than the CellCept arm.|||participants|||Number
2733975|NCT00991510|Secondary|Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil|Tmax was directly obtained from measured values.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||hours||Standard Deviation|Mean
2733976|NCT00991510|Secondary|Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)|PTF was calculated as: (Cmax-Cmin)/(AUCt/t)*100|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||percentage of AUC for a dosing interval||Standard Deviation|Mean
2733977|NCT00991510|Secondary|Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)|Cpd was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||µg /ml||Standard Deviation|Mean
2733978|NCT00991510|Secondary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil|Cmin was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||µg /ml||Standard Deviation|Mean
2733979|NCT00991510|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil|Cmax was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||µg /ml||Standard Deviation|Mean
2733980|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil|For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||hour* µg /ml||Standard Deviation|Mean
2733981|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil|Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||hour* µg /ml||Standard Deviation|Mean
2733982|NCT00991458|Secondary|Worst Outcome Post-LASIK Surgery in Reading Speed Assessment|Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X [Number of words on card - (reading errors)]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.|||Words Per Minute (WPM)||Standard Deviation|Mean
2734058|NCT00991081|Secondary|Perceived Control|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2733983|NCT00991458|Secondary|Percentage of Patients With Cumulative Poor Vision|Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.|Month 3, Month 4, Month 5, Month 6|Intent to treat: all randomized patients.|||Percentage of Patients|||Number
2733984|NCT00991458|Secondary|Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment|The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.|||Seconds||Standard Deviation|Mean
2733985|NCT00991458|Primary|Time to Cure|Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.|6 Months|Modified Intent to Treat: all randomized and treated patients with both eyes having Post-LASIK surgery and corneal sensitivity measurements of < 25 mm in the 3 central regions at Post-Surgery Week 1.|||Days||Inter-Quartile Range|Median
2733986|NCT00991406|Secondary|The Impulse of the Anterior Ground Reaction Force Normalized by Body Mass.|The is the magnitude of ground reaction force over time per step in the anterior direction during walking.|Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study|Volitional and FES data available for participants with hemiparesis.|||Newtons*seconds/body mass in kilograms||Standard Deviation|Mean
2733987|NCT00991406|Secondary|Positive Ankle Work|This is the amount of positive work performed by the ankle during walking normalized by body mass.|Same day; pre-stimulation (volitional) and post-stimulation (FES), day of the study|Volitional and FES data available for participants with hemiparesis.|||Joules/body mass in kilograms||Standard Deviation|Mean
2733988|NCT00991406|Secondary|Peak Ankle Power|This is the peak ankle power during walking normalized by body weight.|Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study|Volitional and FES data available for participants with hemiparesis.|||Watts/body mass in kilograms||Standard Deviation|Mean
2733989|NCT00991406|Primary|Walking Stability and Speed|This was a feasibility study of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. We developed computer models and walking simulations of hemiplegic gait from 8 subjects. We related the model results (muscle activations) to the optimized data collected from hemiplegic subjects & calculated the FES pattern to be delivered in 2 forms (open loop & foot switch triggered). The primary outcome measure turned out to be the feasibility of the methods because after developing our computer modeling and computational optimization framework we could only test walking with the 2 forms of FES at the same preferred walking speed on a treadmill. Thus, the simulated walking speed and the real walking speed pre and post FES turned out to be the same. Walking stability was measured with variability in work performed at the ankle. The additional volitional and FES biomechanical data that were measured are listed in the secondary measures.|pre-stimulation (volitional) and post-stimulation (FES), day of the study|Volitional and FES data available for participants with hemiparesis.|||Joules/body mass in kilograms||Standard Deviation|Mean
2733990|NCT00991341|Secondary|Any Mechanical Ventilation More Than 48 Hours Post-operation||48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
2733991|NCT00991341|Secondary|Days Alive and Ventilator Free Through Post-op Day 28||Through post-op day 28|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||days||Standard Deviation|Mean
2733992|NCT00991341|Secondary|Days to First Solid Food|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative solid food.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.|||days||Standard Error|Mean
2734021|NCT00991289|Primary|Percentage of Participants With Early Virologic Response (EVR)|Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Weeks 0, 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
2734401|NCT00988442|Secondary|Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)|Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.|Week 12|Only participants in the telephone support group were analyzed.|||minutes||Inter-Quartile Range|Median
2733993|NCT00991341|Secondary|Days to First Bowel Movement|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.|||days||Standard Error|Mean
2733994|NCT00991341|Secondary|Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.||||||
2733995|NCT00991341|Secondary|Change in Bilirubin From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||mg/dL||Standard Deviation|Mean
2733996|NCT00991341|Secondary|Change in Lactate From Pre-operative Value to Worst Post-operative Value|The arterial lactate levels were adjusted to make them comparable to venous lactate levels.|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||mmol/L||Standard Deviation|Mean
2733997|NCT00991341|Secondary|Change in Troponin-I From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||ng/mL||Standard Deviation|Mean
2733998|NCT00991341|Secondary|Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||mg/dL||Standard Deviation|Mean
2733999|NCT00991341|Secondary|Ventilation Duration|Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||days||Standard Deviation|Mean
2734000|NCT00991341|Secondary|Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
2734001|NCT00991341|Secondary|Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
2734002|NCT00991341|Secondary|Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
2734003|NCT00991341|Secondary|Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.|The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through 28 days post-surgery, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||MOD score points||Standard Deviation|Mean
2734492|NCT00988169|Primary|Radiographic Objective Response Rate|(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101|21 days after cycle one||||participants|||Number
2734004|NCT00991341|Secondary|All-cause Mortality|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.|28 days post-surgery|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
2734005|NCT00991341|Primary|The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.|The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||MOD score points||Standard Deviation|Mean
2734006|NCT00991302|Secondary|Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)|"The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72.~New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included.~Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit."|From study entry to week 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
2734007|NCT00991302|Secondary|Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score|"The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one's actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant's stronger belief in self-efficacy.~The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero."|At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||scores on a scale||Inter-Quartile Range|Median
2734008|NCT00991302|Secondary|Virologic Suppression|Virologic suppression was defined as HIV-1 RNA <=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.|At week 24, 48, 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2734009|NCT00991302|Secondary|Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48|"The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48.~Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit."|From study entry to week 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
2734010|NCT00991302|Secondary|Mean Self-reported Adherence Score Over a One-month Recall|The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.|Weeks 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||percentage of adherence score||Inter-Quartile Range|Median
2734022|NCT00991289|Primary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
2734059|NCT00991081|Secondary|Motivation|Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734011|NCT00991302|Primary|Mean Self-reported Adherence Score (%) Over a One-month Recall|"The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored.~Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences."|At weeks 4, 12, 24, 36, and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||percentage of adherence score||Inter-Quartile Range|Median
2734012|NCT00991289|Secondary|Number of Participants With HCV Genotype 1|Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).|Week 0|All participants who enrolled, except one participant who was found to have been ineligible after entry.|||participants|||Number
2734013|NCT00991289|Secondary|Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.|Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.|Weeks 0, 4|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HCV viral load measurements available at entry and at Week 4 were analyzed.|||log10 IU/mL||Inter-Quartile Range|Median
2734014|NCT00991289|Secondary|Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry|HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled (except one participant who was found to have been ineligible after entry) and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point.|||percentage of HOMA-IR at study entry||Inter-Quartile Range|Median
2734015|NCT00991289|Secondary|Percent Change in Fasting Glucose Level From Study Entry|Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled (except one participant who was found to have been ineligible after entry) and had FGLUC measurements available at entry and the respective post-entry time point.|||percentage of FGLUC at study entry||Inter-Quartile Range|Median
2734016|NCT00991289|Secondary|Percent Change in Fasting Insulin Level From Study Entry|Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled (except one participant who was found to have been ineligible after entry) and had FINS measurements available at entry and the respective post-entry time point.|||percentage of FINS at study entry||Inter-Quartile Range|Median
2734017|NCT00991289|Secondary|Change in Hemoglobin Level From Study Entry|Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.|All participants who enrolled (except one participant who was found to have been ineligible after entry) and had HGB measurements available at entry and at the respective post-entry time point.|||g/dL||Inter-Quartile Range|Median
2734018|NCT00991289|Secondary|Number of Participants With Adverse Events of Grade 2 or Higher|Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to up to week 76|All participants who enrolled, except one participant who was found to have been ineligible after entry.|||participants|||Number
2734019|NCT00991289|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 8|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 8 HCV viral load result were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
2734020|NCT00991289|Secondary|Percentage of Participants With Sustained Virologic Response (SVR)|Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.|24 weeks after treatment discontinuation|All participants who enrolled, except one who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
2734057|NCT00991081|Secondary|Risk Perception|Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734023|NCT00991276|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)|RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2734024|NCT00991276|Secondary|Medical Outcomes Study - Sleep Scale (MOS-SS)|MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed for particular subscale for each arm group respectively."|||units on a scale||95% Confidence Interval|Least Squares Mean
2734025|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale|SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734026|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2734027|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734028|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||awakenings||95% Confidence Interval|Least Squares Mean
2734029|NCT00991276|Secondary|Hourly and Quarterly Assessment of Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of time asleep||95% Confidence Interval|Least Squares Mean
2734083|NCT00990964|Primary|Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter|Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.|Implant||||participants|||Number
2734030|NCT00991276|Secondary|Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)|PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
2734031|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Arousals (NASO)|NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||arousals||95% Confidence Interval|Least Squares Mean
2734032|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||awakenings||95% Confidence Interval|Least Squares Mean
2734033|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||awakenings||95% Confidence Interval|Least Squares Mean
2734034|NCT00991276|Secondary|Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)|WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||minutes||95% Confidence Interval|Least Squares Mean
2734035|NCT00991276|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Percentage of time asleep||95% Confidence Interval|Least Squares Mean
2734036|NCT00991276|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734037|NCT00991276|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734038|NCT00991276|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734039|NCT00991276|Secondary|Latency to Persistent Sleep (LPS)|"LPS, as determined by PSG, was number of epochs from the beginning of the recording (lights-out) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model."|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734040|NCT00991276|Secondary|Latency to Stage R Sleep (LREM)|LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734041|NCT00991276|Secondary|Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale|CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected.|Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants|||Number
2734042|NCT00991276|Secondary|International Restless Legs Syndrome Study Group Rating Scale (IRLS)|IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2734043|NCT00991276|Secondary|Arousal Index (NASOI)|Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||arousals/hour||95% Confidence Interval|Least Squares Mean
2734044|NCT00991276|Secondary|Number of Arousals (NASO)|NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||arousals||95% Confidence Interval|Least Squares Mean
2734045|NCT00991276|Secondary|Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||awakenings||95% Confidence Interval|Least Squares Mean
2734046|NCT00991276|Secondary|Periodic Limb Movement in Sleep Index (PLMSI)|PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
2734047|NCT00991276|Secondary|Periodic Limb Movement Index (PLMI)|PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
2734048|NCT00991276|Secondary|Restless Legs Syndrome-Next Day Impact (RLS-NDI)|RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2734049|NCT00991276|Secondary|Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||awakenings||95% Confidence Interval|Least Squares Mean
2734050|NCT00991276|Secondary|Minutes of Stage N1, N2, N3 and R Sleep|Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734051|NCT00991276|Secondary|Subjective Total Sleep Time (sTST)|sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734052|NCT00991276|Secondary|Periodic Limb Movement Arousal Index (PLMAI)|PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
2734053|NCT00991276|Primary|Wake After Sleep Onset (WASO)|WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)|Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
2734054|NCT00991185|Primary|CSF:Serum Ratio of Vancomycin|CSF:serum ration of vancomycin|within 1 week of drug administration||||ratio||Full Range|Median
2734055|NCT00991081|Secondary|Threat Minimization|Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734056|NCT00991081|Secondary|Self-Efficacy|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734060|NCT00991081|Secondary|Intention to Quit|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734061|NCT00991081|Secondary|Fatalism|Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs|12 weeks after Target Quit Date|Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30)|||units on a scale||Standard Deviation|Mean
2734062|NCT00991081|Secondary|Depression|Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 30)|||units on a scale||Standard Deviation|Mean
2734063|NCT00991081|Secondary|Treatment Interest Scale|Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734064|NCT00991081|Secondary|Satisfaction Scale|Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734065|NCT00991081|Secondary|Communication Scale|Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734066|NCT00991081|Secondary|Trust Scale|Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
2734067|NCT00991081|Secondary|Morisky Adherence Scale|Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance|12 weeks after Target Quit Date|Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30)|||units on a scale||Standard Deviation|Mean
2734068|NCT00991081|Primary|Continuous Abstinence at 12 Weeks Post Target Quit Date|"Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as abstinent. All others were recorded as not abstinent."|12 weeks after Target Quit Date|All randomized participants were included in the data analysis.|||participants|||Number
2734069|NCT00991029|Other Pre-specified|Death From Any Cause|Other safety outcome: Number of Participants with Death from any cause|up to 90 days||||Participants|||Count of Participants
2734070|NCT00991029|Other Pre-specified|Minor Hemorrhage|Other safety outcome:Number of Participants with Minor hemorrhage|up to 90 days||||Participants|||Count of Participants
2734071|NCT00991029|Other Pre-specified|Major Hemorrhage Other Than Intracranial Hemorrhage|Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage|up to 90 days||||Participants|||Count of Participants
2734072|NCT00991029|Other Pre-specified|Other Symptomatic Intracranial Hemorrhage|Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage|up to 90 days||||Participants|||Count of Participants
2734073|NCT00991029|Other Pre-specified|Symptomatic Intracerebral Hemorrhage|Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage|up to 90 days||||Participants|||Count of Participants
2734074|NCT00991029|Other Pre-specified|Hemorrhagic Stroke|Other safety outcome: Number of participants with Hemorrhagic stroke|up to 90 days||||Participants|||Count of Participants
2734075|NCT00991029|Secondary|Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage|Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage|Up to 90 days||||Participants|||Count of Participants
2734076|NCT00991029|Secondary|Ischemic or Hemorrhagic Stroke|Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke|Up to 90 days||||Participants|||Count of Participants
2734077|NCT00991029|Secondary|Death From Ischemic Vascular Causes|Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes|Up to 90 days||||Participants|||Count of Participants
2734078|NCT00991029|Secondary|Myocardial Infarction|Secondary efficacy outcome: Number of participants with Myocardial infarction|Up to 90 days||||Participants|||Count of Participants
2734079|NCT00991029|Secondary|Ischemic Stroke|Secondary efficacy outcome:Number of participants with Ischemic stroke|Up to 90 days||||Participants|||Count of Participants
2734080|NCT00991029|Primary|Major Hemorrhage|Primary safety outcome: Number of Participants with major hemorrhage|Up to 90 days||||Participants|||Count of Participants
2734081|NCT00991029|Primary|Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes|Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes|Up to 90 days||||Participants|||Count of Participants
2734082|NCT00990964|Primary|Subjects Without a Left-heart Lead and Delivery Catheter Related Complication|A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).|Implant to 3 months||||participants|||Number
2734085|NCT00990821|Primary|Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V|AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.|Up to 72 Hours Post Dose|All participants in Part V who had at least one period of AUC data were included in the evaluation of pharmacokinetics. Participants without sufficient concentration data for an AUC calculation included: 6 participants in the Aprepitant (125 mg) , 8 participants in the MK-0517 (100 mg) group, and 5 participants in the MK-0517 (115 mg) group.|||ng*hr/mL||Standard Deviation|Least Squares Mean
2734086|NCT00990782|Secondary|Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA||14 Days||||Participants|||Count of Participants
2734087|NCT00990782|Primary|Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy||14 days||||Participants|||Count of Participants
2734088|NCT00990769|Secondary|Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)|Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.|Within 30 minutes of arrival in recovery room|All patients were analyzed.|||units on a scale||Standard Deviation|Mean
2734089|NCT00990769|Secondary|Time to Emergence From Anesthesia|The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.|After the completion of surgery|All patients were analyzed|||minutes||Standard Deviation|Mean
2734090|NCT00990769|Primary|Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)|The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.|Within 30 minutes of arrival in recovery room|All patients in each group were analyzed.|||units on a scale||Standard Deviation|Mean
2734091|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH||Over the 12-week treatment period||||Occurrences per participant||Standard Deviation|Mean
2734092|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline||Over the 12-week treatment period||||Occurrences per participant||Standard Deviation|Mean
2734093|NCT00990704|Secondary|Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia||||Percentage of participants|||Number
2734094|NCT00990704|Secondary|Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia||||Percentage of participants|||Number
2734095|NCT00990704|Secondary|Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks||Baseline and the last 3 weeks (Weeks 11, 12, and 13)||||pg/mL||Standard Deviation|Mean
2734096|NCT00990704|Secondary|Mean iPTH at Each Visit||Screening (up to 2 weeks before Baseline) to Week 13||||pg/mL||Standard Deviation|Mean
2734097|NCT00990704|Secondary|The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks||During the last 3 weeks (Weeks 11, 12, and 13)||||Percentage of participants|||Number
2734098|NCT00990704|Primary|The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.||Baseline and the last 3 weeks (Weeks 11, 12, and 13)|All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.|||Percentage of participants|||Number
2734099|NCT00990665|Primary|The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.|The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).|3 Months||||percentage of participants||97.5% Confidence Interval|Number
2734100|NCT00990665|Primary|Freedom From System-related Complications Through 3 Months|The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.|3 Months|Participants implanted with a Promote Q CRT-D device and Quartet LV lead.|||percentage probability||97.5% Confidence Interval|Number
2734101|NCT00990665|Primary|Freedom From Left Ventricular Lead-Related Complications Through 3 Months|The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.|3 months|Patients implanted with a Promote Q CRT-D device and Quartet LV lead.|||percentage probability||97.5% Confidence Interval|Number
2734102|NCT00990652|Secondary|Overall Survival Rate at 6 Months|The rate of overall survival at 6 months (regardless of disease progression) was calculated.|After 6 months on study|The 6-month overall survival rate was based on a median of 168 days of follow-up.|||percentage of participants|||Number
2734103|NCT00990652|Secondary|Overall Survival (in Days)||Days 1, 4, 8 pre-surgery, once per cycle (every 4 weeks) while on treatment post-surgery, and then every 3 months up to 2 years during follow-up||||days||95% Confidence Interval|Median
2734106|NCT00990652|Secondary|Number of Grade 1, 2, 3, 4, and 5 Adverse Events Observed During Study Treatment (Defined by CTCAE v 3.0)|"Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Days 1, 4, 8 pre-surgery, and then at the start of every cycle (approximately every 4 weeks) post-surgery while on treatment||||adverse events|||Number
2734107|NCT00990652|Secondary|Number of Participants Achieving a Response to Treatment (Either Complete or Partial Response) as Defined by MacDonald Criteria|"This measure was assessed only in patients who had residual tumor post-operatively. Per MacDonald Criteria:~Complete Response requires complete disappearance of all measurable & evaluable disease, no new lesions, no evidence of non-evaluable disease, and only minimal or no use of steroids.~Partial Response is defined as >= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, and no new lesions. Responders must be on the same or decreasing doses of steroid.~Response was assessed by imaging (MRI or CT with contrast)."|Day of treatment post-surgery and then approximately every 8 weeks thereafter until off treatment|Only those participants who had residual tumor remaining after surgical resection were evaluated for this outcome.|||participants|||Number
2734108|NCT00990652|Primary|Number of Patients Surviving Without Disease Progression After 6 Months|"Patients will be monitored from date of first treatment to the date of first observation of progressive disease, non-reversible neurologic progression or increasing steroid requirements, death due to any cause, or early discontinuation of treatment. Progression-free survival will be defined as the absence of any of the above after 6 months.~Progression (defined by MacDonald Criteria) is a 25% increase in the sum of products of all measurable lesions over smallest sum observed compared to baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to the cancer)."|From date of first treatment until disease progression, death, or early discontinuation of treatment (up to 24 months)||||participants|||Number
2734109|NCT00990652|Other Pre-specified|Correlation of Expression of NFKBIA Gene With Response to Therapy and Survival.|The effects of bortezomib on the endogenous modulators of NF-Kappa B pathways, especially the NFKBIA gene (nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha) were assessed using novel assay technology; expression of NFKBIA was then correlated with response to therapy and patient survival.|Tissue samples for analysis were obtained on the day of surgery for all patients|||||||
2734110|NCT00990561|Primary|Change in Modified Psoriasis Area Severity Index (PASI) Score|PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).|2 weeks|This was a pilot study and the number was based on the available budget to perform the study.|||units on a scale||Full Range|Mean
2734111|NCT00990509|Primary|Mean Intracerebral Hemorrhage (ICH) Volume|11 of 14 participants received a Day 5 MRI. Mean ICH volume based on 11 participants is presented.|Day 5 MRI||||cc||Standard Deviation|Mean
2734112|NCT00990509|Primary|Assessment of Safety of Albumin Administration in Primary ICH|Serious adverse events. Specific safety outcomes assessed: frank pulmonary edema as visualized on chest X-Ray, congestive heart failure, neurological deterioration (4-point worsening on NIHSS), death|Through Day 90 following enrollment||||events|||Number
2734113|NCT00990509|Primary|Mean Hyperintense Acute injuRy Marker (HARM)|Hyperintense Acute injuRy Marker (HARM) characterizes the frequency and severity of blood brain barrier disruption. Mean HARM is assessed on the post-contrast study using a previously developed 5 point scale (0 to 5).). A score of 0 indicates no HARM, whereas a score of 5 indicates diffuse and generalized HARM. 11 of 14 participants received a Day 5 MRI. HARM reads could only be performed on 4 of the 7 placebo subjects due to insufficient sequences or presence of subarachnoid blood. Mean HARM score is presented.|Day 5 MRI||||points|||Number
2734114|NCT00990340|Secondary|Subject-reported Overall Satisfaction Following the End of Each Period of the Study.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
2734115|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
2734154|NCT00989989|Secondary|Percent of Participants With Visual Acuity Above 73 Letters at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||percentage of participants|||Number
2734116|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like arms were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|2 weeks|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
2734117|NCT00990340|Secondary|Subject-reported Injection Pain Immediately Following Administration.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
2734118|NCT00990340|Primary|Subject-reported Injection Anxiety Immediately Before Administration|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Mean
2734119|NCT00990314|Secondary|Number of Participants With a Change in WHO Functional Class|Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.|Baseline and 42 months|Only participants with both a measurement at Baseline and at the End of Study visit are presented.|||Participants|||Count of Participants
2734120|NCT00990314|Secondary|Number of Participants That Experienced Clinical Worsening|Number of Participants that experienced Clinical Worsening in the opinion of the Investigator. Clinical Worsening was defined as any of these events following the Baseline visit: Death, Transplantation or atrial septostomy, Clinical deterioration as defined by: Hospitalization as a result of PAH symptoms or Initiation of any new PAH specific therapy (e.g. ERA, PDE-5 inhibitor, prostanoid). All efficacy results are descriptive; no statistical analysis was conducted.|Up to 42 months||||Participants|||Count of Participants
2734121|NCT00990314|Secondary|Change in Borg Dyspnea Score|The modified 0-10 category-ratio Borg scale consists of an 11-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) and 10 (for the worst condition) with nonlinear spacing of verbal descriptors of severity corresponding to specific numbers. The participant chose the number or the verbal descriptor to reflect presumed ratio properties of sensation or symptom intensity. Baseline was defined as the last non-missing evaluation preceding the first dose of study drug in study BPS-MR-PAH-203. Only participants with both a measurement at baseline and at the given visit are presented. All efficacy results are descriptive; no statistical analysis was conducted.|Baseline and 42 months|Only participants with both a measurement at Baseline and at the End of Study visit are presented.|||scores on a scale||Standard Deviation|Mean
2734122|NCT00990314|Primary|Number of Reported Treatment-Emergent Adverse Events|A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted.|Up to 42 months||||TEAEs|||Number
2734123|NCT00990314|Secondary|Change in Six-Minute-Walk Distance (6MWD)|"Area used for the Six Minute Walk Test (6MWT) was pre-measured at 30 meters in length. Rest periods were allowed if patient could no longer continue. If patient needed to rest, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called stop while stopping the watch and then measured the distance walked. For purposes of the 6MWT, if patient was assessed at Baseline using oxygen therapy, all future 6MWT were conducted in the same manner. All efficacy results are descriptive; no statistical analysis was conducted."|Baseline and 42 months|Only participants with both a measurement at Baseline and at the End of Study visit are presented.|||meters||Standard Deviation|Mean
2734176|NCT00989833|Secondary|Use of as Needed Medication|Mean number of as needed inhalations taken before exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||number of inhalations per day||Standard Deviation|Mean
2734124|NCT00990314|Primary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)|A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted|Up to 42 months||||Participants|||Count of Participants
2734125|NCT00990288|Secondary|Visual Analog Pain Scale at 6 Weeks|"A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.~The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity."|6 weeks postoperatively|Patients whose pain level at 6-week followup appointment was taken were included in analysis.|||points on visual analog pain scale||Standard Deviation|Mean
2734126|NCT00990288|Primary|Homologous Amount of Transfusion||three days postoperatively||||units of blood||Standard Deviation|Mean
2734127|NCT00990288|Primary|Autologous Amount of Transfusion||three days postoperatively||||units of blood||Standard Deviation|Mean
2734128|NCT00990288|Primary|Drain Output||24 hours postoperatively|Drain output at 24 hours was recorded for all patients.|||mL||Standard Deviation|Mean
2734129|NCT00990288|Primary|Change in Hematocrit on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/L||Standard Deviation|Mean
2734130|NCT00990288|Primary|Change in Hemoglobin on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
2734131|NCT00990288|Secondary|Range of Motion at Six Weeks||6 weeks postoperatively|Patients whose range of motion at 6-week followup appointment was taken were included in analysis.|||degrees||Standard Deviation|Mean
2734132|NCT00990288|Primary|Change in Hematocrit on Day 1 Compared to Preoperatively||preoperatively and 1 day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/L||Standard Deviation|Mean
2734133|NCT00990288|Secondary|Visual Analog Pain Scale on Day 3|"A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.~The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity."|3 days postoperatively|All patients whose pain score was collected were included in analysis.|||points on visual analog pain scale||Standard Deviation|Mean
2734134|NCT00990288|Secondary|Range of Motion on Day 3||3days postoperatively|Patients whose range of motion at 3 day followup appointment was taken were included in analysis.|||degrees||Standard Deviation|Mean
2734135|NCT00990288|Primary|Change in Hemoglobin On Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/dL||Standard Deviation|Mean
2734136|NCT00990288|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis.|||g/L||Standard Deviation|Mean
2734137|NCT00990288|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and on the day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/dL||Standard Deviation|Mean
2734138|NCT00990249|Primary|Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM)|NRM was defined as death from any cause other than disease progression or relapse and reported as percentage of participant deaths. Treatment related deaths after transplant are defined either by deaths which could not be attributed to disease relapse or progression or by deaths without previous relapse or progression. For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring.|100 Days|Only 107 participants were evaluated.|||percentage of participants|||Number
2734139|NCT00990236|Secondary|Incidence of Bleeding Complications|An increase in bleeding complications will be assessed daily during hospitalization|Through study completion, assessed up to 120 days post randomization||||Participants|||Count of Participants
2734140|NCT00990236|Primary|Development of Deep Vein Thrombosis (DVT)|An ultrasound duplex will be completed at least one time after randomization to determine if the subject has developed a DVT.|Through study completion, assessed up to 120 days post randomization||||Participants|||Count of Participants
2734141|NCT00990184|Secondary|Glucose Disappearance Rate|Rate of fall of glucose in the blood|Baseline and 8 weeks||||percentage of glucose/min||Standard Error|Mean
2734142|NCT00990184|Secondary|Insulin Sensitivity|"Tissue response to circulating insulin in the blood. Insulin sensitivity is measured using a mathematical model that quantifies the fractional rate of change in glucose concentrations per unit of insulin. Low values are insulin resistant and high values are insulin sensitive. *Please note: the -1 in the Unit of Measure should be a superscripted value."|Baseline and 8 weeks||||min-1 per pmol/L||Standard Error|Mean
2734143|NCT00990184|Primary|Acute Insulin Response (AIRg) to Intravenous Glucose|Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.|Baseline and 8 weeks|Subjects who completed the study|||pmol/1*min||Inter-Quartile Range|Median
2734177|NCT00989833|Secondary|Concentration of Exhaled Nitric Oxide||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||ppb||Standard Deviation|Mean
2741867|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h||||L||Standard Deviation|Mean
2734144|NCT00990106|Primary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.|Change from Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.|||Percentage of responders||95% Confidence Interval|Number
2734145|NCT00990106|Primary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.|Baseline to Week 15||||Scores on a Scale||Standard Error|Mean
2734146|NCT00990106|Primary|Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15."|Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.|||Scores on a Scale||Standard Error|Mean
2734147|NCT00990093|Primary|Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.|"Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.~At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)"|14 days|Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.|||units on a scale||Standard Deviation|Mean
2734148|NCT00989989|Secondary|Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||units on a scale||Standard Deviation|Mean
2734149|NCT00989989|Secondary|Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Letters||Standard Deviation|Mean
2734150|NCT00989989|Secondary|Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
2734151|NCT00989989|Secondary|Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
2734152|NCT00989989|Secondary|Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
2734153|NCT00989989|Secondary|Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
2734155|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline|Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline.|||percentage of participants|||Number
2734156|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline|Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline.|||percentage of participants|||Number
2734157|NCT00989989|Secondary|Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12|Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system.|||micrometers||Standard Deviation|Mean
2734158|NCT00989989|Primary|Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Letters||Standard Deviation|Mean
2734159|NCT00989950|Primary|Sleep Latency|Measure by daily subject sleep diary|9 weeks|All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter|||minutes||95% Confidence Interval|Mean
2734160|NCT00989937|Secondary|Global Assessment of Functioning (GAF)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734161|NCT00989937|Secondary|Childhood Trauma Questionnaire [CTQ]||Visit 1 (only once)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734162|NCT00989937|Secondary|Reading Trust in the Mind in the Eyes Test (RTET)||Visits 1, 4, 5, 8|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734163|NCT00989937|Secondary|Hamilton-Depression Scale (HAM-D)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734164|NCT00989937|Secondary|Arizona Sexual Experience Scale (ASEX)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734165|NCT00989937|Secondary|Sheehan Disability Scale (SDS)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734166|NCT00989937|Secondary|The Profile of Mood States (POMS)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734167|NCT00989937|Secondary|The State-Trait Anxiety Inventory (STAI)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734168|NCT00989937|Secondary|Social Phobia Inventory (SPIN)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734169|NCT00989937|Secondary|Clinical Global Impression - Global Improvement (CGI-I||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734170|NCT00989937|Secondary|Clinical Global Impression - Severity of Illness (CGI-S||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734171|NCT00989937|Primary|Total Score on the Hamilton Anxiety Scale (HAM-A)||Performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2734172|NCT00989911|Primary|Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months|Magnetic resonance imaging-derived aortic flow|3-6 months||||L/min||Standard Deviation|Mean
2734173|NCT00989833|Secondary|Number of Participants With an Adverse Event During the Study||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Participants|||Number
2734174|NCT00989833|Secondary|Diary Recording of Asthma Symptoms|Asthma symptoms during days with exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Percent of exercise days||Standard Deviation|Mean
2734175|NCT00989833|Secondary|Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)|Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.|Baseline e and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||units on a scale||Standard Deviation|Mean
2734178|NCT00989833|Secondary|Bronchial Responsiveness to Mannitol|Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)|Baseline and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||mg||Standard Deviation|Mean
2734179|NCT00989833|Secondary|Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks|FEV1|Baseline and 3 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Percent change||Standard Deviation|Mean
2734180|NCT00989833|Primary|Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks|FEV1|Baseline and Visit 6|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Percent change||Standard Deviation|Mean
2734181|NCT00989781|Other Pre-specified|Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls|3-D ultrasound was not assessed; instead 2-D ultrasound was performed|baseline||||Antral Follicle Count||Standard Error|Mean
2734182|NCT00989781|Secondary|Anti-Mullerian Hormone (AMH)||Baseline||||ng/ml||Standard Error|Mean
2734183|NCT00989781|Secondary|17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.|17 hydroxyprogesterone levels|Baseline and 24 after hCG||||Participants|||Count of Participants
2734184|NCT00989781|Secondary|Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls|17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame.|Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH||||ng/ml||Standard Error|Mean
2734185|NCT00989781|Primary|17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls|Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection|Baseline and 24 hours after hCG||||ng/ml||Standard Error|Mean
2734186|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|112 days||||microVolts||Standard Deviation|Mean
2734187|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days||||microvolts||Standard Deviation|Mean
2734188|NCT00989768|Primary|Horizontal Action Halo Diameter at 112 Days|The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|112 days||||centimeter||Standard Deviation|Mean
2734189|NCT00989768|Primary|Horizontal Action Halo Diameter at 28 Days|The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|28 Days||||centimeter||Standard Deviation|Mean
2734190|NCT00989664|Secondary|Number of Participants With Hypothyroidism Prior to Therapy and After the Therapeutic Dose|Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the Iodine 131 on thyroid function. Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who were evaluable for thyroid function assessment were analyzed.|||participants|||Number
2734191|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. Grade 3/4 hematological toxicities: hemoglobin <8.0 g/dL; platelets <50,000 cells per millimeters (mm)^3; ANC <1000 cells per mm^3; WBC <2000 cells per mm^3.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population|||participants|||Number
2734192|NCT00989664|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|HAMA are human immunoglobulins with specificity for mouse immunoglobulins. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment. Time to HAMA positivity was calculated as the difference between the day on which HAMA positivity occurred and the first dosimetric dose administration day.|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were analyzed.|||days||Full Range|Median
2734202|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or Grade 4 AEs were analyzed.|||participants|||Number
2741868|NCT00939198|Secondary|Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction||Upon skin testing||||kU/L||Inter-Quartile Range|Median
2734193|NCT00989664|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Before Receiving the Dosimetric Dose) But Positive or Negative After Receiving the Dosimetric Dose|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit."|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.|||participants|||Number
2734194|NCT00989664|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.|||participants|||Number
2734195|NCT00989664|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced any infection were analyzed.|||participants|||Number
2734196|NCT00989664|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced SAEs were analyzed.|||participants|||Number
2734197|NCT00989664|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious AEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.|||participants|||Number
2734198|NCT00989664|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE) Unrelated to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgment.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.|||participants|||Number
2734199|NCT00989664|Secondary|Number of Participants With the Indicated Time to Death From the Last Dose of Study Drug|Time to death from the last dose of study drug is the time period difference between when study drug treatment stopped and when death occurred.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.|||participants|||Number
2734200|NCT00989664|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.|||participants|||Number
2734201|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Related to Study Drug and Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or 4 AEs related to study drug were analyzed.|||participants|||Number
2734493|NCT00988156|Primary|Responder Rate|Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|baseline up to Visit 7||||participants|||Number
2734203|NCT00989664|Secondary|Number of Participants With the Indicated Adverse Events (AE) Related to Study Drug Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced any AE related to study drug were analyzed.|||participants|||Number
2734204|NCT00989664|Secondary|Number of Participants With Responses of CR, CCR, CR+CCR, and PR Following TST and I 131 TST and Following the LQCR, as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
2734205|NCT00989664|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
2734206|NCT00989664|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced treatment failure were analyzed.|||months||95% Confidence Interval|Median
2734207|NCT00989664|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced disease progression or died were analyzed.|||months||95% Confidence Interval|Median
2734208|NCT00989664|Secondary|Number of Participants With Any Confirmed Response (CR, CCR, or PR), Confirmed CR, Confirmed CCR, Confirmed CR+CCR, and Confirmed PR, as Assessed by Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with CR, CCR , or PR. A confirmed response (CR/CCR/PR) had to be confirmed by a consecutive response (>=28 days [ 4 weeks] later) that was the same or better. Individual confirmed response data only counts that response confirmed by the same response; thus, not all possible combinations are represented.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2734209|NCT00989664|Secondary|Number of Participants With Any Uncofirmed Response (CR, Clinical Complete Response [CCR], or PR), CR, CCR, CR+CCR, and PR), as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
2734210|NCT00989664|Primary|Duration of Response for Par. Receiving TST and I 131 TST With a Response >=30 Days Versus the Number of Par. With a Response >=30 Days After Their LQCR, as Assessed by the MIRROR Panel|Duration of response is defined as the time from the first documented response (for par. with complete response, complete response unconfirmed, or partial response) until disease progression (DP). DP is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants with complete response, complete response unconfirmed, or partial response were analyzed.|||months||95% Confidence Interval|Median
2734211|NCT00989664|Primary|Number of Participants (Par.) Receiving TST and I 131 TST With a Response >=30 Days Versus Par. With a Response >=30 Days After Their Last Qualifying Chemotherapy Regimen (LQCR), Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Par. with response are those with complete response (CR; complete resolution of all disease-related radiological abnormalities and the disappearance of all signs/symptoms related to disease), complete response unconfirmed (CRu; meets characteristics of CR, except the nodal size hasn't regressed sufficiently, or there is indeterminate bone marrow), or partial response (PR; >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Participants' LQCR was used as a comparator for subsequent treatment with Iodine I 131TST.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population|||participants|||Number
2734212|NCT00989612|Secondary|Number of Days With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom.|During a 7-day (Days 0-6) follow-up after each vaccination|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Days||Full Range|Median
2734213|NCT00989612|Secondary|Number of Days With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom.|During a 7-day (Days 0-6) follow-up after each vaccination|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Days||Full Range|Median
2734214|NCT00989612|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs).|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (Days 0-182)|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2734215|NCT00989612|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Days 0-182)|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2734216|NCT00989612|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2734217|NCT00989612|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 7-day (Days 0-6) follow-up after each vaccination|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2734218|NCT00989612|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 7-day (Days 0-6) follow-up after each vaccination|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2734219|NCT00989612|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen|A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.|At Days 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734220|NCT00989612|Secondary|Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen|A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8.|At Days 0, 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734221|NCT00989612|Secondary|Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen|Titers are presented as geometric mean titers (GMTs).|At Days 0, 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Titers||95% Confidence Interval|Geometric Mean
2734222|NCT00989612|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.|At Days 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Fold change||95% Confidence Interval|Geometric Mean
2734223|NCT00989612|Secondary|Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Days 0, 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734494|NCT00988156|Primary|Change From Baseline in Seizure Frequency|Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|Baseline up to Visit 7||||seizures/month||Standard Deviation|Mean
2734224|NCT00989612|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.|At Days 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734225|NCT00989612|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|Titers are presented as geometric mean titers (GMTs).|At Days 0, 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Titers||95% Confidence Interval|Geometric Mean
2734226|NCT00989612|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen|A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.|At Days 0, 21, 42 and 182|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734227|NCT00989612|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.|At Day 42|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Fold change||97.5% Confidence Interval|Geometric Mean
2734228|NCT00989612|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Fold change||97.5% Confidence Interval|Geometric Mean
2734229|NCT00989612|Primary|Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 42|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734230|NCT00989612|Primary|Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available|||Participants|||Count of Participants
2734231|NCT00989612|Primary|Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734232|NCT00989612|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.|At Day 42|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734233|NCT00989612|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734234|NCT00989612|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.|At Day 42|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734235|NCT00989612|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734613|NCT00986674|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients|||months||95% Confidence Interval|Median
2734236|NCT00989612|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen|A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Participants|||Count of Participants
2734237|NCT00989612|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|Titers are presented as geometric mean titers (GMTs).|At Day 42|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Titers||97.5% Confidence Interval|Geometric Mean
2734238|NCT00989612|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|Titers are presented as geometric mean titers (GMTs).|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Titers||97.5% Confidence Interval|Geometric Mean
2734239|NCT00989612|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen|Titers are presented as geometric mean titers (GMTs).|At Day 0|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.|||Titers||97.5% Confidence Interval|Geometric Mean
2734240|NCT00989586|Secondary|Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)|Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).|up to 36 weeks|HAHA titres were assayed for patients in Phase I and Phase II|||patients|||Number
2734241|NCT00989586|Secondary|Access Pharmacokinetics Through Cmax|Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-dose|Cmax for patients dosed at 20 mg/kg|||ug/ml||Standard Deviation|Mean
2734242|NCT00989586|Secondary|Access Pharmacokinetics Through AUC0-∞ (Area Under Curve)|Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-does|AUC0–∞ for patients dosed at 20 mg/kg|||d*ug/ml||Standard Deviation|Mean
2734243|NCT00989586|Secondary|Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry|Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year.|up to 1 year|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.||||||
2734244|NCT00989586|Secondary|Fcγ-receptor Polymorphism Response to Treatment|The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.|up to 2 years|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.||||||
2734245|NCT00989586|Secondary|Progression-free Survival (PFS)|Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.|up to 2 years||||months||95% Confidence Interval|Median
2734246|NCT00989586|Primary|Overall Objective Response Rate|Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR.|Up to 2 years||||percent of patients|||Number
2734247|NCT00989586|Primary|Maximum Tolerated Dose (MTD)for Phase I Patients|Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated|up to 2 years||||mg/kg|||Number
2734248|NCT00989586|Primary|Dose Limiting Toxicity (DLT) for Phase I Patients|Dose-limiting toxicity was assessed during induction therapy for phase I.|up to 2 years||||patients|||Number
2734249|NCT00989287|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2734250|NCT00989287|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2741869|NCT00939198|Primary|Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection||15 minutes after skin test application||||cm||Inter-Quartile Range|Median
2734251|NCT00989287|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 364|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2734252|NCT00989287|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period. No subjects from the GSK2340269A Group reported any temperature after Dose 2.|During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2734253|NCT00989287|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2734254|NCT00989287|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period. No subjects in GSK2340269A Group reported redness or swelling.|During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2734255|NCT00989287|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2734256|NCT00989287|Secondary|Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
2734257|NCT00989287|Secondary|Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2734258|NCT00989287|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2734259|NCT00989287|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2734260|NCT00989287|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects (antibody titer < 10 post-vaccination), antibody titer ≥ 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2734272|NCT00989287|Primary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2743460|NCT00928018|Secondary|To Compare 2-year Progression-free Survival Between the Two Treatment Arms||2 years||||percentage of participants||95% Confidence Interval|Number
2734261|NCT00989287|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2734262|NCT00989287|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2734263|NCT00989287|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2734264|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2734265|NCT00989287|Secondary|Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2734266|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2734267|NCT00989287|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734268|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2734269|NCT00989287|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734270|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2734271|NCT00989287|Primary|Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2734273|NCT00989287|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
2734274|NCT00989261|Secondary|Early Treatment-related Death|Early treatment-related deaths included all treatment-related deaths prior to the end of Cycle 3 with a 3-day window (Cycle 3 end date + 3 days), unless the death was following a CRc response assessed by the Investigator.|Within first 3 cycles of treatment (84 days)|Early treatment-related deaths were assessed in the Safety Population.|||participants|||Number
2734275|NCT00989261|Secondary|Median Duration of Overall Survival in FLT3-ITD (-) Participants|Kaplan-Meier analysis of overall survival (Safety Population)|Time from first dose to death from any cause, up to approximately 3 years post treatment|Overall survival was assessed in the Safety Population (FLT3-ITD [-] participants).|||weeks||95% Confidence Interval|Median
2734276|NCT00989261|Secondary|Median Duration of Overall Survival in FLT3-ITD (+) Participants|Kaplan-Meier analysis of overall survival (Safety Population)|Time from first dose to death from any cause, up to 3 years post treatment|Overall survival was assessed in the Safety Population (FLT3-ITD [+] participants).|||weeks||95% Confidence Interval|Median
2734277|NCT00989261|Secondary|Median Duration of Leukemia-free Survival in FLT3-ITD (-) Participants|Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).|From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment|Leukemia-free survival (based on local morphology) was assessed in the Safety Population (FLT3-ITD [-] participants).|||weeks||95% Confidence Interval|Median
2734278|NCT00989261|Secondary|Median Duration of Leukemia-free Survival in FLT3-ITD (+) Participants|Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).|From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment|Leukemia-free survival (based on local morphology) was assessed in the Safety Population (FLT3-ITD [+] participants).|||weeks||95% Confidence Interval|Median
2734279|NCT00989261|Secondary|Duration of Any Response in FLT3-ITD (-) Participants|Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).|From the time of any response until disease progression or death, up to approximately 3 years post treatment|Response (based on local morphology) was assessed in the Safety Population (FLT3-ITD [-] participants).|||weeks||95% Confidence Interval|Median
2734280|NCT00989261|Secondary|Duration of Any Response in FLT3-ITD (+) Participants|Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).|From the time of any response until disease progression or death, up to approximately 3 years post treatment|Response (based on local morphology) was assessed in the Safety Population (FLT3-ITD [+] participants).|||weeks||95% Confidence Interval|Median
2734281|NCT00989261|Secondary|Duration of Composite Complete Remission in FLT3-ITD (-) Participants Who Achieved CRc Based on All On-Treatment Data|"Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).~The definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of >1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria."|From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment|Duration of composite complete remission was assessed in the Safety Population based on FLT3-ITD (-) participants available for this analysis (Cohort 1: n=16; Cohort 2: n=12).|||weeks||95% Confidence Interval|Median
2734282|NCT00989261|Secondary|Duration of Composite Complete Remission in FLT3-ITD (+) Participants Who Achieved CRc Based on All On-Treatment Data|"Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).~The definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of >1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria."|From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment|Duration of composite complete remission was assessed in the Safety Population based on FLT3-ITD (+) participants available for this analysis (Cohort 1: n=63; Cohort 2: n=62).|||weeks||95% Confidence Interval|Median
2734283|NCT00989261|Primary|Number of Participants With Composite Complete Remission (CRc), Categorised by FLT3-ITD Status|CRc is defined as composite complete remission (CR+CRp+CRi) - CR = complete remission; CRp = complete remission with incomplete platelet recovery; CRi = complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia = all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib = all criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion.|within 28 months|Composite complete remission was assessed in the Safety Population.|||participants|||Number
2734292|NCT00989235|Secondary|Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment|All neoplasms were assessed by medical review as to whether or not the event was malignant.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
2734643|NCT00986427|Secondary|Growth of the Treated and Untreated Nail in the Previous 4 Weeks|Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.|Week 24||||Millimeters (mm)||Standard Deviation|Mean
2734284|NCT00989261|Primary|Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [-] Participants)|"Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD[-] Participants)~Modified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission."|Within the first 3 cycles of treatment (84 days)|Derived disease assessments were conducted in the Safety Population (FLT3-ITD [-] participants).|||participants|||Number
2734285|NCT00989261|Primary|Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)|"Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD[+] Participants)~Modified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission."|Within the first 3 cycles of treatment (84 days)|Derived disease assessments were conducted in the Safety Population (FLT3-ITD [+] participants).|||participants|||Number
2734286|NCT00989235|Secondary|Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment|A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'|After 12 months of treatment|Number of participants analyzed= Number of participants with available immunogenicity measurements|||participants|||Number
2734287|NCT00989235|Secondary|Clinically Significant Changes in Vital Signs and Physical Findings|Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.|||participants|||Number
2734288|NCT00989235|Secondary|Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment|Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure|||percentage of participants|||Number
2734289|NCT00989235|Secondary|Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity|A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
2734290|NCT00989235|Secondary|Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
2734291|NCT00989235|Secondary|Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
2734316|NCT00989157|Primary|AUCo-inf,|Area under the plasma concentration time curve|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||ng h/mL||Standard Deviation|Mean
2734317|NCT00989157|Primary|Tmax|Time to maximum plasma concentration|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||Hours||Standard Deviation|Mean
2734293|NCT00989235|Secondary|Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
2734294|NCT00989235|Secondary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
2734295|NCT00989235|Secondary|Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment||Day 701 of the main study; sub-study Days 1, 85, 169, 253|Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted..|||ng/mL||Standard Deviation|Mean
2734296|NCT00989235|Secondary|Percentage of Participants Who Lost Remission Status|Loss of remission is defined as DAS 28 CRP >=2.6.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
2734297|NCT00989235|Secondary|Percentage of Participants Who Modified Therapy During Double-Blind Treatment|Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
2734298|NCT00989235|Secondary|Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
2734299|NCT00989235|Primary|Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)|An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.|||Percentage of Events|||Number
2734300|NCT00989235|Secondary|Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids|A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants|||Number
2734301|NCT00989235|Secondary|Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment|Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
2734302|NCT00989235|Secondary|Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)|DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
2734303|NCT00989235|Secondary|Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.|||units on a scale||Standard Error|Mean
2734318|NCT00989157|Secondary|Emesis|episodes of emesis.|4 days||||number of occurences|||Number
2737819|NCT00965185|Secondary|Endothelial Function|Assessment of endothelial function was to be measured by endothelial vasodilator function.|1 year|"Please note that we were unable to collect data for this outcome measure, entitled Endothelial Function due to equipment malfunction."||||||
2734304|NCT00989235|Secondary|Mean Time-Matched Baseline DAS28 CRP Scores|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline|Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2734305|NCT00989235|Secondary|Number of Participants Experiencing Disease Relapse|Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits.|After 12 Months of treatment|Number of participants analyzed=number randomized.|||Participants|||Number
2734306|NCT00989196|Secondary|Immunogenicity (Number of Patients That Developed an Inhibitor During the Course of the Study)|Inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) at study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for some patients who may finish the study before they achieve 50 EDs), with human-cl rhFVIII (i.e. at the study completion visit).|study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for||||participants|||Number
2734307|NCT00989196|Secondary|Efficacy of On-demand Treatment of Bleeding Episodes|"After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 - 12 hours after an infusion requiring up to 2 infusions for complete resolution.~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.~The assessment was made at the end of a BE in case more than one infusion was needed."|From 1st treatment after PK cycle 2 until study end.||||percentage of bleeding episodes|Bleeding episodes||Number
2734308|NCT00989196|Secondary|Clearance (CL) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||mL/h/kg||Standard Deviation|Mean
2734309|NCT00989196|Secondary|Volume of Distribution at Steady State (Vss) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||mL/kg||Standard Deviation|Mean
2734310|NCT00989196|Secondary|Mean Residence Time (MRT) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||hours||Standard Deviation|Mean
2734311|NCT00989196|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||hours||Standard Deviation|Mean
2734312|NCT00989196|Secondary|Maximum Plasma Concentration (Cmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||IU/mL||Standard Deviation|Mean
2734313|NCT00989196|Secondary|Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||hours||Standard Deviation|Mean
2734314|NCT00989196|Primary|The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||h IU/mL (IU/kg)||Standard Deviation|Mean
2734315|NCT00989157|Primary|T1/2|Half life|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||hours||Standard Deviation|Mean
2734320|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During Weeks 5-12|The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).|||days||Standard Deviation|Mean
2734321|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During Weeks 5-12|The number of standard units of RBCs transfused during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of week 5 (study day 29).|||units of red blood cells||Standard Deviation|Mean
2734322|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12|The number of participants with at least one RBC transfusion during weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).|||Participants|||Number
2734323|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During the Test Period|The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.|||days||Standard Deviation|Mean
2734324|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During the Test Period|The average number of standard units of red blood cells transfused during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.|||units of red blood cells||Standard Deviation|Mean
2734325|NCT00989092|Primary|Number of Hospitalizations During the Test Period|Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.|||hospitalizations||Standard Deviation|Mean
2734326|NCT00989092|Primary|Days of Hospitalization During the Test Period|Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.|||days||Standard Deviation|Mean
2734327|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period|Number of participants with at least one RBC transfusion during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm with available data.|||Participants|||Number
2734328|NCT00989092|Secondary|Change From Baseline in Hemoglobin Level|The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion. LVCF imputation was used.|||g/dL||Standard Deviation|Mean
2734329|NCT00989092|Secondary|Hematopoietic Response During the Test Period|The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.|||Participants|||Number
2734330|NCT00989092|Secondary|Hemoglobin Response During the Test Period|The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.|||Participants|||Number
2734331|NCT00989092|Secondary|Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13|The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Participants also needed to have completed the baseline and at least 1 post-baseline FACT-Fatigue questionaire. Last Value Carried Forward (LVCF) imputation used.|||units on a scale||Standard Deviation|Mean
2734332|NCT00989092|Secondary|Total Hospital Costs During the Test Period|The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and were included in the hospital bill database. Participants who were not hospitalized had a cost of $0 imputed.|||dollars||Standard Deviation|Mean
2734333|NCT00989092|Primary|Number of Participants Hospitalized During the Test Period|Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.|Weeks 1- 12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.|||Participants|||Number
2753408|NCT00853242|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2734335|NCT00988884|Secondary|Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™|Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves >50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||Titer||95% Confidence Interval|Geometric Mean
2734336|NCT00988884|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
2734337|NCT00988884|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
2734338|NCT00988884|Primary|Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.|Day 1 through Day 5 following Day 1 or Month 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs|||Percentage of participants|||Number
2734339|NCT00988884|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs|||Percentage of participants|||Number
2734340|NCT00988884|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||ELU/mL||Full Range|Geometric Mean
2734341|NCT00988884|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
2734342|NCT00988884|Primary|Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups|For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.|Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
2734343|NCT00988884|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||milli Merck Units/mL||Full Range|Geometric Mean
2734344|NCT00988858|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pemetrexed||Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr|All randomized participants who received at least 1 dose of drug and had evaluable PK data.|||microgram*hour per milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2734345|NCT00988858|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618||Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of drug and had evaluable PK data|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2734346|NCT00988858|Secondary|PK: Maximum Plasma Concentration (Cmax) of Pemetrexed||Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr|All randomized participants who received at least 1 dose of drug and evaluable PK data.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2734347|NCT00988858|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618||Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of drug and evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2734348|NCT00988858|Secondary|Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)|The LCSS participants scale is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS.|Baseline until End of Study (Up to 27.1 Months)|The LCSS evaluable population consisted of all enrolled participants who had a baseline LCSS measurement and at least 1 post-baseline measurement. The population was evaluated for changes in the ASBI (improved, stable, worsened), with improvement/worsening based on trends seen in sets of consecutive ASBI assessments with respect to baseline ASBI.|||participants|||Number
2734349|NCT00988858|Secondary|Duration of Response|Duration of Response is defined as the time from the first observation of CR or PR to the first observation of progressive disease (PD) or death from any cause. A response is defined as a confirmed objective status of CR or PR. For participants who are not known to have died as of the data inclusion cut-off date and who do not have PD, the duration will be censored at the date of the last objective progression free disease assessment prior to the date of any subsequent anticancer therapy.|First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)|All randomized participants who received at least 1 dose of drug with Best Overall Response of Complete Response or Partial Response.5 participants were censored.|||months||90% Confidence Interval|Median
2734350|NCT00988858|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)|All randomized participants who received at least 1 dose of drug. 9 participants were censored.|||months||90% Confidence Interval|Median
2734351|NCT00988858|Secondary|Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)|Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)|All randomized participants who received at least 1 dose of drug.|||percentage of participants||90% Confidence Interval|Number
2734352|NCT00988858|Primary|Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)|All randomized participants who received at least 1 dose of drug.|||percentage of participants||95% Confidence Interval|Number
2734353|NCT00988832|Primary|Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of diagnostic tests conducted during outpatient consultations were calculated as per the 2008-2009 NHS Reference Costs. Costs for diagnostic tests during hospitalizations and A&E visits were incorporated into cost analyses for those categories and are not included here.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734700|NCT00986180|Secondary|Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event|Number of subjects that reported constipation as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
2734354|NCT00988832|Primary|Mean Cost Per Participant for Crohns-related Medications|Costs of biologics were calculated by multiplying the number of vials of drug used per participant by the 2009 British National Formulary (BNF) cost per vial. Costs of other drugs with ≥10 prescriptions were calculated by multiplying the 2009 BNF daily cost of the standard/most-prescribed dose of the most-prescribed drug (reference drug) in each drug group (Anatomical Therapeutic Classification [ATC] Level 4) by the length of treatment. Costs for drugs in drug groups with ≤9 prescriptions were calculated using the average cost of all Crohns medications multiplied by the length of treatment.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734355|NCT00988832|Primary|Mean Cost Per Participant of Accident and Emergency (A&E) Visits|Costs for visits to A&E without admission. Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease as per the 2009 Healthcare Resource Group (HRG) descriptors.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734356|NCT00988832|Primary|Mean Cost Per Participant for All Hospitalizations|"Costs for all hospitalizations, including costs associated with elective~and emergency (non-elective) admissions as well as outpatient procedures."|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734357|NCT00988832|Primary|Mean Cost Per Participant for Admissions for Day Case Surgery|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of day case (outpatient) surgeries were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for any surgeries that did not require the participant to stay overnight in the hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734358|NCT00988832|Primary|Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734359|NCT00988832|Primary|Mean Cost Per Participant of Elective Surgical Procedures|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of elective surgical procedures were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for elective surgeries that required participants to be admitted into a hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734360|NCT00988832|Primary|Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of outpatient consultations are based on the 2009 Unit Cost of Health and Social Care published by the Personal Social Service Research Unit. Consultations with gastroenterologists, gastric/gastrointestinal surgeons, radiologists, nurses/Inflammatory Bowel Disease nurses, dieticians/nutrition specialists, psychologists/psychiatrists, pharmacists, and occupational therapists are included in the analysis.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
2734361|NCT00988637|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4|Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.|Baseline to Week 4|Safety|||participants|||Number
2734362|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I Would Use This Treatment Program Again if Recommended by the Dermatologist at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I would use this treatment program again if recommended by the dermatologist at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)|||participants|||Number
2734363|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With the Results of This Treatment Program at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am satisfied with the results of this treatment program at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)|||participants|||Number
2734364|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With my Appearance at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am Satisfied with my Appearance at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)|||participants|||Number
2734365|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question The Treatment Program Was Easy to Follow at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question The treatment program was easy to follow at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Baseline and Week 4|ITT (Intent to Treat)|||participants|||Number
2734380|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent to treat population.|||Percent of Participants|||Number
2734366|NCT00988637|Secondary|Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4|Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.|Baseline to Week 4|ITT (Intent to Treat)|||Units on a scale||Standard Deviation|Mean
2734367|NCT00988637|Secondary|Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4|Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||Percent change||Standard Deviation|Median
2734368|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||participants|||Number
2734369|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||participants|||Number
2734370|NCT00988637|Secondary|Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4|Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)|||participants|||Number
2734371|NCT00988637|Secondary|Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4|Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||participants|||Number
2734372|NCT00988637|Secondary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to week 2|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2734373|NCT00988637|Primary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2734374|NCT00988559|Secondary|Absence of CIN2/3 Lesion by Week 15|Number of participants with no CIN2/3 lesion at the week 15 visit|15 weeks|Number of participants who had no CIN2/3 at the week 15 resection|||Participants|||Count of Participants
2734375|NCT00988559|Primary|Number of Participants With Related Serious Adverse Events|Presence of intervention-related serious adverse events as defined by CTCAE|9 months|Related Serious Adverse Events|||Participants|||Count of Participants
2734376|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||hour||Standard Deviation|Mean
2734377|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||ng/mL||Standard Deviation|Mean
2734378|NCT00988533|Secondary|Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.|||mg/dL||Standard Deviation|Mean
2734379|NCT00988533|Secondary|Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.|||U/L||Standard Deviation|Mean
2737820|NCT00965185|Secondary|Plaque Progression|12 month percent change in plaque volume|Measured at baseline and 1 year|All available data were used.|||Percent change||95% Confidence Interval|Mean
2734383|NCT00988533|Primary|Summary of Pharmacokinetic Parameters Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||ng/h/mL||Standard Deviation|Mean
2734384|NCT00988533|Primary|Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||ng/mL||Standard Deviation|Mean
2734385|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Anxiety/Depression|Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.|Week 24|Available data from participants who made it to week 24 are summarized.|||Participants|||Count of Participants
2734386|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Pain/Discomfort|Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.|Week 24|Available data from participants who reached week 24 are summarized.|||Participants|||Count of Participants
2734387|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Usual Activities|Quality of Life Measured by Euro-QoL - Question 3: Usual activities.|Week 24|All available data from participants that reached week 24 are summarized.|||Participants|||Count of Participants
2734388|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Self-Care|Quality of Life Measured by Euro-QoL - Question 2: Self-Care.|Week 24|All available data from participants that reached week 24 are summarized.|||Participants|||Count of Participants
2734389|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Mobility|Quality of life measured by Euro-QoL - Question 1: Mobility.|Week 24|Available data for participants that reached week 24 are summarized.|||Participants|||Count of Participants
2734390|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale|ARV medication adherence at Week 24, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.|Week 24|Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome.|||percentage of HIV meds taken last month||Inter-Quartile Range|Median
2734391|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale|ARV medication adherence at week 12, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.|Week 12|Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome.|||percentage of HIV meds taken last month||Inter-Quartile Range|Median
2734392|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall|"ARV medication adherence, as measured by four day recall, i.e. Missed doses in last 4 days."|Week 24|Due to early study closure, only 39 participants had adherence data at week 24.|||Participants|||Count of Participants
2734393|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall|"ARV medication adherence at week 12, as measured by four day recall, i.e. Missed doses in last 4 days."|Week 12|Due to early study closure, only 42 participants had adherence data at week 12 for this outcome.|||Participants|||Count of Participants
2734394|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire|ARV medication adherence at week 24, as measured by the ACTG adherence questionnaire index. The ACTG adherence questionnaire index is on a 0-100 scale where higher scores indicate better adherence.|Week 24|Due to early study closure, 31 participants had complete adherence data for this outcome.|||units on a scale||Inter-Quartile Range|Median
2734395|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire|ARV medication adherence at week 12, as measured by the ACTG adherence questionnaire index. This questionnaire index is on a 0-100 scale, with higher scores indicating higher adherence.|Week 12|Due to early study closure, only 30 participants had complete adherence data for this outcome.|||units on a scale||Inter-Quartile Range|Median
2734396|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48.|Measured at Week 48|Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis.|||Participants|||Count of Participants
2734397|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.|Week 24|Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.|||Participants|||Count of Participants
2734398|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.|Week 12|Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis.|||Participants|||Count of Participants
2734399|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.|Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.|Week 24|Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.|||Participants|||Count of Participants
2734400|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12|Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.|Week 12|Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis.|||Participants|||Count of Participants
2753409|NCT00853242|Secondary|Change From Baseline in Total Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2734402|NCT00988442|Secondary|Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)|Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.|Measured at Week 12|Only participants in the telephone support group were analyzed.|||percent of scheduled calls delivered||Standard Deviation|Mean
2734403|NCT00988442|Secondary|Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period|Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.|Measured from entry to Week 72 or premature study discontinuation|Only participants in the telephone support group were analyzed.|||participants|||Number
2734404|NCT00988442|Secondary|Number of Participants With Virological Suppression|Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.|Measured from entry to Week 72 or premature study discontinuation|All participants with scheduled post baseline HIV-1 RNA measurements.|||participants|||Number
2734405|NCT00988442|Secondary|Number of Participants With Illness Events or Mortality|Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.|Measured from entry to Week 72 or premature study discontinuation|Due to early study closure, only 59 participants were accrued and followed on study.|||Participants|||Count of Participants
2734406|NCT00988442|Secondary|Cost of the Adherence Telephone Interventions|This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.|Week 48|This outcome was not analyzed, since the intervention was not determined to be successful.||||||
2734407|NCT00988442|Secondary|Confirmed Virologic Failure|Number of participants with confirmed virologic failure. Virologic failure is defined as confirmed HIV-1 RNA ≥200 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 20 weeks after the date of randomization).|Week 24 through Week 72|The analysis population was all participants randomized to a treatment arm in this trial.|||Participants|||Count of Participants
2734408|NCT00988442|Secondary|Change in CD4 Cell Count at Week 48|Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.|Baseline and Week 48|Only 16 participants had week 48 CD4 observations to be included in this analysis.|||cells/mm^3||95% Confidence Interval|Mean
2734409|NCT00988442|Secondary|Change in CD4 Cell Count at Week 24|Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.|Baseline and Week 24|Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis.|||cells/mm^3||95% Confidence Interval|Mean
2734410|NCT00988442|Secondary|Change in CD4 Cell Count at Week 12|Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.|Baseline and Week 12|Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis.|||cells/mm^3||95% Confidence Interval|Mean
2734411|NCT00988442|Secondary|Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation|Number of premature ART regimen discontinuations, defined as the first substitution, subtraction, or addition of one or more ARVs made to the initial study regimen.|From study entry to Week 72|All participants with available ART data.|||participants|||Number
2734412|NCT00988442|Primary|Number of Participants With Virologic Suppression|Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.|Week 48|All participants enrolled who had Week 48 HIV-1 RNA results available were included in this intent-to-treat-analysis. At the time of early study closure, 14 participants had reached week 48.|||Participants|||Count of Participants
2734413|NCT00988429|Secondary|Proportion of Responders|Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.|Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||percentage of participants||95% Confidence Interval|Number
2734414|NCT00988429|Primary|Seizure Frequency Over the 12-week Maintenance Period.||12-week maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||Nº Standardized Seizures by 4 weeks||Standard Error|Least Squares Mean
2734415|NCT00988351|Secondary|Treatment Pressure (Level of CPAP or 90th Percentile APAP)|The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.|6 weeks clinic|participants using PAP at the 6 weeks clinic visit|||cm H2O||Standard Deviation|Mean
2734416|NCT00988351|Secondary|Residual Apnea-hypopnea Index|The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.|over first 6 weeks of treatment|participants using PAP at clinic visit (>= 1/2 hour of nightly use)|||events (apneas+hypopneas)/hour||Standard Deviation|Mean
2734417|NCT00988351|Secondary|Change in Functional Outcomes of Sleep Questionnaire|The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.|6 weeks at clinic|Using PAP 1/2 hour or more nightly|||units on a scale||Standard Deviation|Mean
2734418|NCT00988351|Secondary|Change in Epworth Sleepiness Scale|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.|6 weeks after starting treatment||||units on a scale||Standard Deviation|Mean
2734419|NCT00988351|Primary|Positive Airway Pressure Adherence (Nightly Use of Treatment)|average nightly hours of using positive airway pressure (including 0 for nights not used)|6 weeks after starting treatment|patients using cpap or apap at clinic visit|||hours||Standard Deviation|Mean
2734420|NCT00988325|Secondary|Number of Participants Showing Within-patient Variability in Vital Signs|Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and heart rate were examined for any consistent within-patient post-baseline changes.|Post baseline, Day 3, 4, 6, 11, 18+/- 2 days, 30+/-2 days|Safety population included all treated participants with at least one post-baseline safety assessment. Due to the small numbers of participants and the extent of influenza induced variability, changes in vital sign patterns cannot be detected.||||||
2734421|NCT00988325|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Secondary Illness|An Adverse Event (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Secondary illnesses were influenza disease-related events, namely bronchitis, pneumonia, otitis media, and sinusitis that resolved without sequelae. Adverse events, serious adverse events, and secondary illness are reported for on-treatment period (from the first dose of oseltamivir upto 3 days after the last dose of oseltamivir [Approximately 14 days].|Up to 3 days after the last dose of oseltamivir (Approximately 14 days)|Safety population included all treated participants with at least one post-baseline safety assessment|||Participants|||Number
2734422|NCT00988325|Secondary|Percentage of Participants With Decline of Body Temperature to the Afebrile State|This was performed for all participants who had fever at baseline Fever is defined as body temperature >37.0ºC. Rectal temperature is converted by subtracting 1 ºC. The rate of decline of body temperature was calculated as the slope of body temperature between the baseline temperature and the 1st temperature below 37°C. Participants with decline in body temperature were considered to have no fever; however, participants who did not show any decline in body temperature were considered to have persisting fever.|Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 days|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||percentage of participants|||Number
2734423|NCT00988325|Secondary|Time to Resolution of Fever in Participants With Fever at the Baseline|This was performed for all participants who had fever at baseline. Fever is defined as body temperature >37.0 degree Celsius. Rectal temperature is converted by subtracting 1 degree Celsius. Time to Resolution of Fever was defined as the time from the initiation of treatment to first time the afebrile state was reached and maintained for at least 21.5 hours, where afebrile state was defined as axillary temperature ≤ 37 degree Celsius.|Days 1 to 11; Day 18; Day 30|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||hours||Full Range|Median
2734424|NCT00988325|Secondary|Number of Participants With Virus Shedding by Virus Type|The viral titer was measured by culture and reported in log10 (50% tissue culture infective dose [TCID50]). The viral load was analyzed by PCR and reported as log10 particles/mL. The number of patients positive for viral shedding by virus sub-type was measured on specified days from baseline to last visit on Day 30.|Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 days|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||Participants|||Number
2734425|NCT00988325|Secondary|Median Time to Cessation of Viral Shedding in Participants With Positive Culture at Baseline|Median time to cessation of viral shedding was calculated for all patients with positive by culture / by polymerase chain reaction (PCR) at baseline using all data points between the start of the treatment and the 1st time point of negative culture without subsequent positive culture results. These time-to event analyses were only performed for the viral titre.|Days 1, 3 or 4, 6, 11, 18, and 30|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||hours||95% Confidence Interval|Median
2734426|NCT00988325|Secondary|Number of Participants With Change From Baseline in Neurological Assessment Scores|Neurological assessment was performed to assess the mental state of the participants through two scales: Infant face scale and Glasgow coma scale. Each scale consists of 3 subscales: eye opening (ranging 1 to 4), verbal response (ranging 1 to 5), and motor responses (ranging 1 to 6). The final score is the sum of these ranges and is scored between 3 and 15. 3 being the worst, and 15 the best. Change from baseline is change of final score post-baseline minus the final score at baseline.|Baseline (Day 1); Day 3 for who received two does on Day 1 or Day 4 for who received one dose on Day 1; Day 6, Day 11, Day 18, Day 30|Safety population included all treated participants with at least one post-baseline safety assessment|||participants|||Number
2734427|NCT00988325|Secondary|Time of the Last Measurable Plasma Concentration for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.|||hours||Geometric Coefficient of Variation|Geometric Mean
2734428|NCT00988325|Secondary|Clast of Oseltamivir and Oseltamivir Carboxylate|The last measurable plasma concentration of oseltamivir and oseltamivir carboxylate was the last quantifiable concentration of oseltamivir or oseltamivir carboxylate, respectively.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated patients with at least one blood sample evaluable for drug concentration level and who were adhered to the protocol|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2734508|NCT00988091|Secondary|Change From Baseline in Patient Global Assessment at Week 26|Participants were asked to mark along a 100mm visual analog scale (VAS) indicating the point best representing the severity of the knee pain that day. The left side of the VAS was 0=no pain and the right side was 100 = extreme pain. Change from baseline was calculated as Week 26 - Baseline.|Day 0 (baseline), Week 26|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2734429|NCT00988325|Secondary|The Volume of Distribution as a Function of Bioavailability of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.|||mL||Geometric Coefficient of Variation|Geometric Mean
2734430|NCT00988325|Secondary|Total Plasma Clearance as a Function of Bioavailability and Apparent Plasma Clearance of the Metabolite as a Function of Bioavailability (CLm/F) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||mL/hour||Standard Deviation|Mean
2734431|NCT00988325|Primary|Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2734432|NCT00988325|Primary|Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2734433|NCT00988325|Secondary|Apparent First-order Elimination Rate Constant of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir.The apparent first-order elimination rate constant (Lambda Z) was determined by linear regression analysis of terminal data points. A minimum of 3 data points were used for lambda Z estimation. By reporting tool convention, if n<3, no summary statistics were calculated|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2734434|NCT00988325|Secondary|Apparent Elimination Half Life of Oseltamivir and Oseltamivir Carboxylate|Elimination half-life is defined as the time required for elimination of a drug to half its plasma concentration and was computed using non-compartmental method|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/-15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||hours||Geometric Coefficient of Variation|Geometric Mean
2734435|NCT00988325|Secondary|Time to the Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.Tmax was estimated using non-compartmental methods|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||hours||Full Range|Median
2734436|NCT00988325|Primary|Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||hour (h)*nanogram(ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2734437|NCT00988247|Secondary|Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 52 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 52|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
2734438|NCT00988247|Secondary|Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 30 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 30|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
2734439|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2734440|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
2734441|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2734442|NCT00988247|Primary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2734443|NCT00988221|Secondary|Height Standard Deviation Score at Baseline, Week 52, and Week 104|The height Standard Deviation Score was calculated using the following formula: (Observed height - median of the reference population)/standard deviation of the reference population. The reference population was defined as that of the same sex and age to the nearest completed year and month using the World Health Organization norms. A negative score indicates less height than the reference population.|Baseline to Week 104|Growth population: All participants who received at least 1 dose of tocilizumab but who did not take the growth hormone somatotropin.|||Standard deviation score||Standard Deviation|Mean
2734444|NCT00988221|Secondary|Methotrexate Dose at Baseline, Week 52, and Week 104|Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.|||mg/m^2/week||Standard Deviation|Mean
2734445|NCT00988221|Secondary|Oral Corticosteroid Dose at Baseline, Week 52, and Week 104|Due to the different types of corticosteroid medications available, the prednisone equivalent was used in the calculation of the oral corticosteroid dose. Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All patients randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.|||mg/kg/day||Standard Deviation|Mean
2734446|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.|||Percent of patients|||Number
2734447|NCT00988221|Secondary|Percent of Patients in Clinical Remission From Week 40 to 104|A patient was in clinical remission if they had inactive disease at all visits in the 6 months prior to and including the visit assessment day. A patient was judged to have inactive disease if all of the following criteria were met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms 'uveitis' and 'intermediate uveitis'; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician's global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 40 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.|||Percent of patients|||Number
2734448|NCT00988221|Secondary|Percent of Patients With Inactive Disease From Week 16 to Week 104|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms 'uveitis' and 'intermediate uveitis'; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician's global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 16 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.|||Percent of patients|||Number
2734449|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104|The patient or parent/guardian, as appropriate, provides a rating of the patient's pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'no pain' and the extreme right end represents 'very extreme pain'. A higher score indicates more pain. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Units on a scale||Standard Deviation|Mean
2734450|NCT00988221|Secondary|C-reactive Protein Levels From Baseline to Week 104|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.|||mg/L||Standard Deviation|Mean
2734451|NCT00988221|Secondary|Percent of Patients With a Minimally Important Improvement in the Children's Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104|The CHAQ-DI consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A minimally important improvement is an improvement ≥ 0.13 over Baseline. Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.|||Percent of patients|||Number
2734452|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at Week 104|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Percent change||Standard Deviation|Mean
2734453|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at Week 104|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Percent change||Standard Deviation|Mean
2734701|NCT00986180|Secondary|Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event|Number of subjects that reported vomiting as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
2734454|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at Week 104|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Percent change||Standard Deviation|Mean
2734455|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at Week 104|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.|||Percent change||Standard Deviation|Mean
2734456|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at Week 104|The patient or parent/guardian, as appropriate, provides a rating of the patient's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.|||Percent change||Standard Deviation|Mean
2734457|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at Week 104|The patient's treating physician provides a rating of the patient's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.|||Percent change||Standard Deviation|Mean
2734458|NCT00988221|Secondary|Change From Baseline in the Juvenile Arthritis Disease Activity Score-71 (JADAS-71) at Week 104|The JADAS-71 is composed of 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range = 0-10, left end of the line = arthritis inactive, ie, symptom-free and no arthritis symptoms; right end = arthritis very active), patient/parent global assessment of overall well-being on a VAS (range = 0-10, left end of the line = very well, ie, symptom-free and no arthritis disease activity; right end = very poor, ie, maximum arthritis disease activity), normalized erythrocyte sedimentation rate (ESR) (range = 0-10, If ESR is ≤ 20 mm/h, set to 0. If ≥ 120 mm/h, set to 10 mm/h. If > 20 mm/h and < 120 mm/h, apply formula: [ESR − 20 mm/h]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). The JADAS-71 is the sum of the 4 component scores and ranges from 0-101. A higher score indicates more arthritis disease activity. A positive change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Only patients with non-missing data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2734459|NCT00988221|Secondary|Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Results are reported for the subgroups: Previous biologic treatment (yes/no), concomitant methotrexate use (yes/no), rheumatoid factor (positive/negative), concomitant oral corticosteroid use (yes/no). Last observation carried forward was applied to missing components at visits.|Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.|||Percent of patients|||Number
2734460|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Week 2 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study.|||Percent of patients|||Number
2734461|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part II of the Study (Week 40)|"A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms 'uveitis' and 'intermediate uveitis'; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician's global assessment of overall well-being visual analog scale score ≤ 10.~The statistical test is not significant due to a break in the hierarchical chain of significance testing."|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Percent of patients||95% Confidence Interval|Number
2734462|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient's pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'no pain' and the extreme right end represents 'very extreme pain'. A higher score indicates more pain. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward (LOCF) imputation for missing values. The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids, and the pain visual analog scale score at Baseline. The adjusted means from the fitted model are presented.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
2734463|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) at the End of Part II of the Study (Week 40)|The Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
2734464|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part II of the Study (Week 40)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||mm/hour||Standard Deviation|Mean
2734465|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part II of the Study (Week 40)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Joints||Standard Deviation|Mean
2734466|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part II of the Study (Week 40)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Joints||Standard Deviation|Mean
2734467|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
2734497|NCT00988143|Other Pre-specified|Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 up to 21 days post-vaccination|Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
2734468|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part II of the Study (Week 40)|The patient's treating physician provides a rating of the patient's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A higher score indicates more disease activity. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
2734469|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Percent of patients||95% Confidence Interval|Number
2734470|NCT00988221|Secondary|Percent of Patients With an Elevated White Blood Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|White blood cells were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
2734471|NCT00988221|Secondary|Percent of Patients With an Elevated Platelet Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Platelets were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
2734472|NCT00988221|Secondary|Percent of Patients With an Elevated Erythrocyte Sedimentation Rate at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
2734473|NCT00988221|Secondary|Percent of Patients With an Elevated C-reactive Protein Concentration at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
2734474|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part I of the Study (Week 16)|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms 'uveitis' and 'intermediate uveitis'; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician's global assessment of overall well-being visual analog scale score ≤ 10.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
2734475|NCT00988221|Secondary|Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient's pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'no pain' and the extreme right end represents 'very extreme pain'. A higher score indicates more pain.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Units on a scale||Standard Deviation|Mean
2734476|NCT00988221|Secondary|Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16)|The JADAS-27 is derived from the following components: Physician's global assessment of disease activity on a 0-100 mm visual analog scale (VAS)/10, patient/parent's global assessment of overall well-being on a 0-100 mm VAS/10, normalized erythrocyte sedimentation rate (ESR) (if ESR is ≤ 20 then set to 0, if ≥ 120 then set to 10, and if > 20 and < 120 then apply formula [ESR-20]/10), and number of joints (maximum of 27) with active arthritis (cervical spine, left/right elbow, left/right wrist, left/right MCP1-3, left/right PIP1-5, left/right hips, left/right knee and left/right ankle). The scores for the first 3 components range from 0-10; the score for the final component ranges from 0-27. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Units on a scale||Standard Deviation|Mean
2734495|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).|||Titers||95% Confidence Interval|Geometric Mean
2753410|NCT00853242|Secondary|Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22||Baseline, Day 22|Full Analysis Set.|||mg^2/dL^2||Standard Deviation|Mean
2734477|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16)|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
2734478|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
2734479|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
2734480|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
2734481|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
2734482|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16)|The patient's treating physician provides a rating of the patient's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
2734483|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
2734496|NCT00988143|Other Pre-specified|Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)."|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
2734702|NCT00986180|Secondary|Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event|Number of subjects that reported nausea as a treatment-emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
2734484|NCT00988221|Primary|Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40)|JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving > 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 16 through Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Percent of patients||95% Confidence Interval|Number
2734485|NCT00988208|Secondary|Time to Onset of Secondary Primary Malignancies|Time of Onset of Secondary Primary Malignancies was considered an event of interest|The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).|||months||Full Range|Median
2734486|NCT00988208|Secondary|Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial|Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.|The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment lenalidomide/placebo, Docetaxel, or Prednisone).|||percentage of participants|||Number
2734487|NCT00988208|Secondary|Percentage of Participants Who Received Post-Study Therapies|Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.|The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).|||Percentage of Participants|Participants||Number
2734488|NCT00988208|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).|||participants|||Number
2734489|NCT00988208|Secondary|Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria|Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones|From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months|Based on the ITT population|||percentage of participants|||Number
2734490|NCT00988208|Secondary|Progression-Free Survival (PFS)|PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan|From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months|Based on the Intent to treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not.|||Weeks||95% Confidence Interval|Median
2734491|NCT00988208|Primary|Overall Survival (OS)|Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.|From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months|Intent-to-Treat (ITT) population defined as all randomized patients irrespective of whether they received treatment or not.|||weeks||95% Confidence Interval|Median
2734498|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2734499|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 21 post-vaccination|Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.|||Participants|||Number
2734500|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2734501|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)"|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.|||Participants|||Number
2734502|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2734503|NCT00988143|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.|"Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.~(24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.~(Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.~Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity."|Day 0 up to 7 days post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.|||Participants|||Number
2734504|NCT00988117|Secondary|Pre-post Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2734505|NCT00988117|Primary|Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)|On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.|Baseline and 12 weeks|Data were missing for two of the patients on the CPT post-treatment due to a computer error.|||milliseconds||Full Range|Median
2734506|NCT00988117|Primary|Resting State Functional Activity Change From Baseline to 12 Weeks|Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.|Baseline and 12 weeks|All patients who completed the study were included.|||z-score||Standard Deviation|Mean
2734507|NCT00988091|Secondary|Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function (WOMAC Disability score) and global assessment (Patient Global Assessment Score) scales. Each of the individual scales was completed by the participant. A responder showed considerable improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. Response at Week 26 is compared to baseline.|Day 0 (baseline), week 26|Intent to treat population|||percentage of participants|||Number
2734509|NCT00988091|Secondary|Number of Tablets of Rescue Medication Used Between Visits|Acetaminophen (500-mg tablets) was provided to study participants as a rescue medication in case they needed a pain medication during the study. The mean number of tablets of rescue medication should have been summarized, however the data was not captured in a reliable way and is therefore not reported.|Day 1 to week 26||||tablets||Standard Deviation|Mean
2734510|NCT00988091|Secondary|Subjective Patient Assessment of Treatment at Week 26|"At the end of the double-blind period (week 26), participants were asked: Are you satisfied with the results of the injection? Answers could be: 1=dissatisfied; 2=slightly satisfied; 3=satisfied; or 4=very satisfied."|Week 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
2734511|NCT00988091|Secondary|Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score. The percent of participants who showed a 20mm or greater improvement in the pain scores at week 26 compared to baseline are reported.|Day 0 (baseline), Week 26|Intent to treat population|||percentage of participants|||Number
2734512|NCT00988091|Secondary|Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26|Adjusted mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm = no pain, stiffness and difficulty; 100 mm = extreme pain, stiffness and difficulty. Change from baseline calculated as: Week 26 minus baseline.|Day 0 (baseline), week 26|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2734513|NCT00988091|Primary|Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.|Day 0 (baseline) through Week 26|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2734514|NCT00988065|Other Pre-specified|Percentage of Participants With an Adverse Event Suggestive of a Dose-dependent Trend That Also Exceeds a Frequency Threshold Above 5% in Any Treatment Arm (Including Both Serious and Non-serious Adverse Events).|All adverse events from the study were reviewed for potential safety signals. The reported incidences suggestive of a dose-dependent trend and with a frequency threshold above 5% (including both serious and non-serious adverse events) are presented.|From first randomized dose (Day 8) up to 30 days after day of last randomized dose of study medication.|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants|||Number
2734515|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review & determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.~The percentages of subjects who had adjudicated hypersensitivity (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) are presented for each of the 3 treatment arms for each dose."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated, per dose (i.e. who received the corresponding dose of randomized study medication).|||percentage of participants|||Number
2734516|NCT00988065|Secondary|The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine anaphylaxis according to the criteria put forth by the guidelines of the Brighton Collaboration Anaphylaxis Working Group as described by Rüggeberg et al. (Vaccine 2007; 25:5675-5684).~Level 1 represents the highest level of certainty of anaphylaxis and level 3 the lowest level of certainty.~The percentages of subjects who had adjudicated anaphylaxis according to the Rüggeberg Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants|||Number
2734517|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine whether the subject's hypersensitivity sign/symptoms fulfilled the definition of anaphylaxis according to the criteria defined by the Symposium on the Definition and Management of Anaphylaxis as described by Sampson et al. (J Allergy Clin Immunol 2006; 117:391-7).~The percentages of subjects who had adjudicated anaphylaxis according to the Sampson Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants||95% Confidence Interval|Number
2734518|NCT00988065|Primary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review and determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.~The percentages of subjects who had adjudicated hypersensitivity at any dose (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants||95% Confidence Interval|Number
2734703|NCT00986180|Secondary|Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation||Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
2734519|NCT00988052|Secondary|Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study|"Shifts are presented as Baseline finding / Worse finding at anytime during the study.~Categories for findings are:~normal~abnormal, not clinically significant (Not CS)~abnormal, clinically significant (CS)"|Day 1 up to 7.64 years|Safety analysis set of participants with both a baseline and a post-baseline ECG.|||Participants|||Count of Participants
2734520|NCT00988052|Secondary|Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study|"Counts include two conditions:~a change from High / Non-PCS at baseline to Low PCS at any point during the study~a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count."|Day 1 up to 7.64 years|Safety analysis set of participants with both a baseline and a post-baseline value for the test.|||Participants|||Count of Participants
2734521|NCT00988052|Secondary|Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study|"Counts include two conditions:~a change from High / Non-PCS at baseline to Low PCS at any point during the study~a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non- PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium"|Day 1 up to 7.64 years|Safety analysis set of participants with both a baseline and a post-baseline value for the test.|||Participants|||Count of Participants
2734522|NCT00988052|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs|"Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria:~Pulse rate low: <=45 and decrease >=30 beats/minute~Pulse rate high: >=120 and increase >=30 beats/minute~Systolic blood pressure low: <=90 and decrease >=30 mmHg~Systolic blood pressure high: >=180 and increase >=30 mmHg~Diastolic blood pressure low: <=50 and decrease >=20 mmHg~Diastolic blood pressure high: >=100 and increase >=20 mmHg"|Day 1 up to 7.64 years|Safety analysis set of participants with a baseline and post-baseline value for that vital sign.|||Participants|||Count of Participants
2734523|NCT00988052|Primary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.|Day 1 up to 7.64 years|Safety analysis set|||Participants|||Count of Participants
2734524|NCT00988000|Secondary|Number of Required Investigations|reduction in number of required investigations|0-6 months||||number of investigation|||Number
2734525|NCT00988000|Primary|Patient Satisfaction of the Alternative Consultation|Patient Satisfaction assessed by MISS scale, Medical interview satisfaction score. The score 0-7, 0 means dissatisfaction, higher scores indicate higher satisfaction.|First clinic appointment (Month 0) and Follow-up appointment (6 months|Incomplete data and those that had an alternative consultation did not need a follow up appointment|||score on a scale||Standard Deviation|Mean
2734526|NCT00987948|Secondary|Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores|The Z-score represents the number of standard deviations away from the mean, with positive Z-scores representing better neuropsychological performance and negative Z-scores representing poorer neuropsychological performance. Z-scores have been adjusted based on age- and education-matched norms.|Baseline to 24 Weeks|6 of 12 patients who completed the study who had mild to moderate cognitive impairment|||Z-score||Inter-Quartile Range|Median
2734527|NCT00987948|Primary|Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells|Week 24 minus baseline|Baseline to 24 weeks|Outcome measure in the 12 patients who completed the study.|||Log-10 copies/10^6 cells||Inter-Quartile Range|Median
2734528|NCT00987935|Secondary|fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib|"fe0-12,ss (fraction excreted in urine between 0 and 12 hours at steady state) for Nintedanib.~The reported value corresponds to the percentage of administered dose."|0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanib|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||percentage||Geometric Coefficient of Variation|Geometric Mean
2734529|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 glucuronide in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2734540|NCT00987935|Secondary|Time to Progression (TTP) in Phase II (Follow-up Analyses)|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeks|Treated set, Only phase II participants|||months||Inter-Quartile Range|Median
2734530|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2734531|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the Nintedanib in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2734532|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 Glucuronide (Metabolite of Nintedanib)|"AUC0-12,ss,norm of BIBF 1202 glucuronide (Metabolite of Nintedanib):~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2734533|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 (Metabolite of Nintedanib)|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of BIBF 1202 (metabolite of Nintedanib).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2734534|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of Nintedanib~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2734535|NCT00987935|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, include only phase II participants|||months||Inter-Quartile Range|Median
2734536|NCT00987935|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.|||months||Inter-Quartile Range|Median
2734537|NCT00987935|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.~95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.|||percentage of participants||95% Confidence Interval|Number
2734538|NCT00987935|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).|||participants|||Number
2734539|NCT00987935|Secondary|Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.|Incidence and worst intensity (severity) of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)|Treated set|||participants|||Number
2734541|NCT00987935|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (28 Sep 2012); Up to 77 weeks|Treated set, only phase II participants.|||months||Inter-Quartile Range|Median
2734542|NCT00987935|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set (Patients from the dose escalation part that were not replaced for MTD determination)|||mg|||Number
2734543|NCT00987831|Post-Hoc|Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).||12 months|Only 40/41 entered patients completed the study by the definition of the endpoint which was flare.|||days to flare||95% Confidence Interval|Median
2734544|NCT00987831|Primary|Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline|Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI </= 10. Severe disease required >3 BILAG B, OR at least one BILAG A OR SLEDAI > 10 or meeting criteria for a severe flare on the SELENA SLEDAI flare index. At baseline 25 patients with moderate disease. 16 patients had severe disease. Note: severe rash with A on BILAG is only SLEDAI=2, explaining some discrepancies in measures|12 months|This prespecified primary outcome was restricted to Group A only. This was an exploratory proof of concept study, not powered for the primary endpoint|||days to flare||95% Confidence Interval|Median
2734545|NCT00987727|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35|Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.|||Number on a scale (score)||Standard Deviation|Mean
2734546|NCT00987727|Primary|Change From Baseline in Global Ocular Staining Score at Day 35|Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.|||Number on a scale (score)||Standard Deviation|Mean
2734547|NCT00987623|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent|1 week|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
2734548|NCT00987558|Primary|Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14||||ng.h/mL||Standard Deviation|Mean
2734549|NCT00987558|Primary|Simvastatin AUC0-t|"AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification~Simvastatin (Reference) ESL + Simvastatin (Test)"|Day 1 and Day 14||||ng.h/mL||Standard Deviation|Mean
2734550|NCT00987558|Primary|Simvastatin Tmax (Time of Occurrence of Cmax)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14||||hours||Standard Deviation|Mean
2734551|NCT00987558|Primary|Simvastatin Cmax (Maximum Plasma Concentration)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14||||ng/mL||Standard Deviation|Mean
2734552|NCT00987480|Secondary|Disease-free Survival at 3 Years|"Defined as time from date of transplant to relapse, graft rejection or graft failure, or death.~Primary non-engraftment is diagnosed when the participants fails to achieve an ANC >/= 500/ul at any time in the first 28 days post-transplant.~For participants with MDS or AML, relapse will be analyzed as to type and genetic origin of the MDS/leukemic cells. These will be defined by an increasing number of blasts in the marrow over 5% by the presence of circulating peripheral blasts, or by the presence of blasts in any extramedullary site. Cytogenetic analysis of the marrow and/or peripheral blood will also be obtained for the diagnosis of relapse."|3 years||||percentage of participants|||Number
2734553|NCT00987480|Secondary|Overall Survival at 3 Years|Overall Survival is defined as time from date of transplant to event (death from any cause) or last follow-up.|3 years||||percentage of participants|||Number
2734554|NCT00987480|Primary|The Incidence of Chronic GvHD||2 years||||Participants|||Count of Participants
2734555|NCT00987480|Primary|The Incidence of Acute GvHD||100 days||||percentage of participants|||Number
2734556|NCT00987480|Primary|The Incidence of Early Transplant Related Mortality||2 years||||Participants|||Count of Participants
2734557|NCT00987480|Primary|Successful Neutrophil Engraftment||2 years||||Participants|||Count of Participants
2734558|NCT00987467|Secondary|Corticosteroid Usage|Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period|Entire follow-up period (Approximately 12 months)||||Total number of flare-up episodes|||Number
2734583|NCT00986999|Secondary|Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels||3 months|||||||
2734584|NCT00986999|Secondary|Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes||3 months|||||||
2734559|NCT00987467|Primary|Ocular Symptoms and Signs Total Composite Score|Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0- maximum 18. These scores are combined to yeild a total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of Atopic Keratoconjunctivitis (AKC). The composite score is reported.|Baseline and 8 weeks||||units on a scale||Full Range|Mean
2734560|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||meters||Standard Deviation|Mean
2734561|NCT00987415|Secondary|Change in Quality of Life (KCCQ)|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||units on a scale||Standard Deviation|Mean
2734562|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||meters||Standard Deviation|Mean
2734563|NCT00987415|Secondary|Change in Quality of Life (KCCQ).|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||units on a scale||Standard Deviation|Mean
2734564|NCT00987415|Primary|A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.|CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved|24 Weeks||||participants|||Number
2734565|NCT00987402|Primary|Surgical Site Infection|255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).|30 days post-operatively||||Participants|||Number
2734566|NCT00987402|Secondary|Cost of Hand Preparation Agent|Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.|30 days|||||||
2734567|NCT00987337|Secondary|Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin||Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose|Data could not be summarized due to sparse sampling time points adopted for this study.||||||
2734568|NCT00987337|Secondary|Number of Participants With Laboratory Test Abnormalities by Severity|Number of participants with laboratory abnormalities by Division of Auto Immune Disease Syndrome (DAIDS) grade of 4; 3 or 4; 2, 3 or 4 was summarized. Abnormal laboratory values refers to a DAIDS grade greater than 0, where grade 1= mild, grade 2= moderate, grade 3= severe and grade 4 = potentially life-threatening.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2734569|NCT00987337|Secondary|Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||participants|||Number
2734570|NCT00987337|Secondary|Number of Participants Who Discontinued Study Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||participants|||Number
2734571|NCT00987337|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 72 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. Treatment-related were events considered related to study drug by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||participants|||Number
2734585|NCT00986999|Primary|Change in Flow Mediated Dilatation (FMD) of the Brachial Artery||3 months|Not analyzed||||||
2734586|NCT00986986|Secondary|HDL||12 weeks|||||||
2734587|NCT00986986|Primary|Flow Mediated Vasodilation|Flow mediated vasodilation is a marker of endothelial function|12 weeks||||percentage change in FMD||Inter-Quartile Range|Median
2734572|NCT00987337|Secondary|Number of Adverse Events (AEs) by Severity (All Causality)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). The most severe grade was used in case of multiple occurrences of the same event.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||adverse events|||Number
2734573|NCT00987337|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24|Plasma HCV RNA levels were measured using the Roche COBAS TaqMan assay (limit of detection: 15 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4, 12, 24|ITT population included all randomized participants who took at least 1 dose of study drug. LOCF method was used for imputing missing values for participants who did not discontinue from study. Final value was imputed as baseline for participants who discontinued before the time point of interest.|||log10 IU/mL||Standard Deviation|Mean
2734574|NCT00987337|Secondary|Percentage of Participants With Relapsed Response|A participant was considered to have relapsed response if the plasma HCV RNA levels were undetectable at end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) but detectable (>=15 IU/mL) during the off-treatment follow-up period up to Week 72. Overall percentage of participants with relapsed response was summarized.|Week 24 or Week 48 up to Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Participant with all the HCV RNA values missing during follow-up was imputed as having relapsed.|||percentage of participants|||Number
2734575|NCT00987337|Secondary|Percentage of Participants With Breakthrough Viremia|A participant was considered to have breakthrough viremia if there was a >2 log10 increase from nadir in HCV RNA concentration while on treatment or HCV RNA that became undetectable with treatment but then became persistently detectable (2 or more consecutive viral RNA measurements >1000 IU/mL) again during treatment. Overall percentage of participants with breakthrough viremia was summarized.|Baseline up to Week 48|ITT population included all randomized participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2734576|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)|SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48).|24 weeks after completion of therapy (Week 48 or 72)|ITT population.N (number of participants analyzed)=evaluable participants for the measure. Missing HCV RNA value at EOT, all follow-up visits/at specified time point, all subsequent visits was considered not to have undetectable HCV RNA.Missing HCV RNA value at 24 weeks after EOT was imputed using value of subsequent follow-up visit, if available.|||percentage of participants|||Number
2734577|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)|A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized.|12 weeks after completion of therapy (Week 36 or 60)|ITT population. Participant with missing HCV RNA values at end of treatment and all follow-up visits or at the specified time point and all subsequent visits was considered not to have undetectable HCV RNA. Missing HCV RNA value at 12 weeks following completion of therapy was imputed using value of subsequent follow-up visit, if available.|||percentage of participants|||Number
2734578|NCT00987337|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48|Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL.|Week 4, 12, 24, 48|ITT population included all randomized participants who took at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values for participants who did not discontinue from study. Participants who discontinued early from the study were considered not to have undetectable HCV RNA.|||percentage of participants|||Number
2734579|NCT00987337|Primary|Percentage of Participants With Sustained Viral Response (SVR) at Week 72|For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 24 (End of Treatment [EOT]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.|Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. If a participant had a missing value at Week 72, participant was considered a failure; if a participant had achieved SVR but died or discontinued within same time period, the participant was considered a success.|||percentage of participants|||Number
2734580|NCT00986999|Secondary|Change in hsCRP||3 months|||||||
2734581|NCT00986999|Secondary|Change in Total, HDL and LDL Cholesterol and Triglyceride Levels||3 months|||||||
2734582|NCT00986999|Secondary|Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing||3 months|||||||
2734589|NCT00986986|Primary|Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12|Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.|Two time points (baseline and study week 12)|HIV infected patients with HDL-C < 40|||percentage change in FMD||Inter-Quartile Range|Median
2734590|NCT00986973|Secondary|Delis-Kaplan Executive Function System Verbal Fluency Subtest (D-KEFS)|The Delis-Kaplan Executive Function System (D-KEFS) is a neuropsychological test is used to measure a variety of verbal and nonverbal executive functions for both children and adults. Among the 9 subtests is the Verbal Fluency Test which measures letter fluency, category fluency, and category switching. Verbal Fluency Test. This subtest requires an individual to randomly generate words based upon given parameters (ex., as words beginning with the letter F) and the believed areas of executive function assessed are cognitive flexibility, response inhibition, and verbal fluency. Raw scores are calculated based on the number of correct answers, which are then converted to scaled scores with a mean of 10 and standard deviation of 3. Higher scaled score represents a higher level of executive verbal and nonverbal function.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all assessments.|||units on a scale||Inter-Quartile Range|Median
2734591|NCT00986973|Secondary|Wechsler Adult Intelligence Scale (WAIS-IV)-Digit Span|The Wechsler Adult Intelligence Scale (WAIS) is a test designed to measure intelligence in adults and older adolescents. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale intelligence quotient (IQ). Contained within the WAIS is an assessment of digit-coding which consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured, with a higher score representative of a higher performance component of IQ/intelligence.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all WAIS-IV assessments.|||Number of correct symbols||Inter-Quartile Range|Median
2734592|NCT00986973|Secondary|Symbol-Digit Modalities Test (SMTD)|The symbol-digit modalities test (SDMT) was developed to identify individuals with neurological impairment. The SDMT requires individuals to identify nine different symbols corresponding to the numbers 1 through 9, and to practice writing the correct number under the corresponding symbol. Then they manually fill the blank space under each symbol with the corresponding number. A second oral administration is then completed. The participant is given a blank copy of the test and asked to state the correct number for each corresponding symbol. The participant is given 90 s to complete each of these administrations. A written and oral score is calculated by totaling the number of correct answers for each section. The score is the number of correctly coded items from 0-110 in 90 seconds, with a higher score representing less neurological impairment with respect to attention, scanning abilities and motor skills. The total raw score was used for purposes of this study.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all SMTD assessments.|||units on a scale||Inter-Quartile Range|Median
2734593|NCT00986973|Secondary|Paced Auditory Serial Addition Task (PASAT)|"The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. For Rates #1 and #2, single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score preferred as it indicates higher auditory processing speed) for each trial. All scores are expressed as z-scores which are generated based on norms for 101 healthy adults, with separate norms for <12 years of education versus >12years of education. Using a reference population as a basis of comparison, the z-score is the number of standard deviations the score is above (positive) or below (negative) the mean of the reference population (zero). Possible z-scores lie on a continuous scale."|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all PASATassessments.|||units on a scale||Inter-Quartile Range|Median
2734594|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|"The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to T-scores by means of age-based tables provided in test manual (T-scores can go from 0 - 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared."|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.|||units on a scale||Inter-Quartile Range|Median
2734595|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Total Recall|"The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to T-scores by means of age-based tables provided in test manual (T-scores can go from 0 - 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared."|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.|||units on a scale||Inter-Quartile Range|Median
2734596|NCT00986973|Primary|Plasma Phenylalanine Level (mg/dl)|Plasma phenylalanine level (mg/dl) served as the primary means of evaluating brain glucose metabolism before and after sapropterin (KUVAN) therapy. Blood tests for phenylalanine levels (Phe) were collected before and 4 months after sapropterin (KUVAN) therapy. All subjects received KUVAN at a dose of 20/mg/kg/day for four months. The goal was to estimate the change in blood glucose metabolism after treatment with Sapropterin (if any), with the hypothesis that treatment would decrease plasma Phe levels.|Measurements were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 subject was withdrawn from the study due to poor compliance with KUVAN therapy.|||mg/dl||Standard Deviation|Mean
2734597|NCT00986960|Secondary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. in RRMS on Anterior Optic Pathway Pathology, as Measured by OCT and LCLA in Patients With RRMS.|The study was terminated - no activity.|The study was terminated - no activity.|||||||
2734598|NCT00986960|Primary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. on a Voxel-wise MTR Dynamic Mapping of the Lesions and NABT in Patients With RRMS|None. Study did not initiate recruitment or data collection. The study was terminated - no activity.|1 year|The study was terminated - no activity.||||||
2734599|NCT00986947|Secondary|Decrease in Panel Reactive Antibody||4 months|Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.||||||
2734600|NCT00986947|Primary|Time to Kidney Transplantation||4 months|Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.||||||
2734601|NCT00986921|Secondary|Moderate or Severe Pain Overnight|Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)|Overnight|All participants are included|||percentage of participants|||Number
2734602|NCT00986921|Secondary|Assessment of Ease of Procedure by Operator|"The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult."|It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.|"All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated easy or very easy is tabulated"|||percentage of participants|||Number
2734603|NCT00986921|Primary|Time for Completion of Procedure|Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)|Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.|Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.|||Minutes||95% Confidence Interval|Mean
2734604|NCT00986856|Secondary|The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).|Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.|EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)|||Units on a scale||Standard Error|Mean
2734605|NCT00986856|Secondary|Number of Patients With Bacteriological Success at EOT||EOT: Visit at day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline|||Participants|||Number
2734606|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation|||Participants|||Number
2734607|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 2||Visit 2: Day 4|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline|||Participants|||Number
2734608|NCT00986856|Secondary|Number of Patients With Clinical Success at EOT||EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)|||Participants|||Number
2734609|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation|||Participants|||Number
2734610|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 2||Visit 2: Day 4|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)|||Participants|||Number
2734611|NCT00986856|Primary|Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).||EOT: Visit at Day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline|||Participants|||Number
2734612|NCT00986674|Secondary|Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients who have response data. 3 patients on arm I and 1 patient on arm III had unknown/missing tumor response and were excluded from the analysis|||percentage of participants||95% Confidence Interval|Number
2743923|NCT00925054|Secondary|Number of Participants With Positive PAL IgG Antibody|Antibody against PAL (phenylalanine ammonia lyase) measured over time|Baseline, Week 12|safety population|||Participants|||Count of Participants
2734614|NCT00986674|Primary|Progression Free Survival|"Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .~All eligible and treated patients were included in the analysis."|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients|||months||95% Confidence Interval|Median
2734615|NCT00986583|Secondary|Fasciculation|The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.|postoperative||||participants|||Number
2734616|NCT00986583|Secondary|Duration of Succinylcholine Block|Time required to reach maximum block by succinylcholine after succinylcholine administration.|intraoperative: from succinylcholine administration||||minute||Inter-Quartile Range|Median
2734617|NCT00986583|Secondary|Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively|Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively|2 and 24 hours postoperatively|Two patients in the nonstatin group had missing CK value at 2 hour|||units/l||Inter-Quartile Range|Median
2734618|NCT00986583|Secondary|Serum Potassium Concentration||At 5 and 20 min after succinylcholine|Two patients in non-statin group had missing value at 20 minute.|||mEq/l||Inter-Quartile Range|Median
2734619|NCT00986583|Secondary|Muscle Pain|"verbal rating scale score and the pain score both at 2 and 24 hours postoperatively.~The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable).~The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain."|2 and 24 hours postoperatively||||participants|||Number
2734620|NCT00986583|Primary|Plasma Myoglobin Concentration||induction, 5 minutes after administration, 20 minutes and 24 hours post operatively||||ug/l||Inter-Quartile Range|Median
2734621|NCT00986570|Primary|Treatment Success|Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.|Baseline (pre-treatment) and Visit 3 (Day 15)||||% of participants||95% Confidence Interval|Number
2734622|NCT00986544|Secondary|Number of Participants With Postoperative Complications||1 month|Intention to treat analysis|||participants|||Number
2734623|NCT00986544|Primary|Number of Participants With Subhepatic Collection at Ultrasonographic Examination|An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.|first postoperative day|An intention to treat (ITT) analysis was performed.|||Participants|||Number
2734624|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Positive Score.|Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.||||Units on a scale||Standard Error|Least Squares Mean
2734625|NCT00986479|Secondary|Visual Analogue Scale (VAS) Anxious Score.|"The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between extreme sad (0-mm) and extreme happy (100-mm), with a median normal point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734626|NCT00986479|Secondary|Young Mania Rating Scale (YMRS) Score.|Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734627|NCT00986479|Secondary|Beck Depression Inventory (BDI) Score.|Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734628|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Score.|"The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126.~18 is considered to be the best outcome, 126 the worst."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734644|NCT00986427|Secondary|Change From Baseline in Quality of Life (QOL) Related to Nail Disease|"Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: Overall, how satisfied are you with your nails? Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24||||scores on a scale||Standard Deviation|Mean
2734629|NCT00986479|Secondary|Clinician-Administered Dissociative States Scale (CADSS) Score.|Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734630|NCT00986479|Secondary|Visual Analogue Scale (VAS) Depressed Score|"The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between extreme sad (0-mm) and extreme happy (100-mm), with a median normal point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.|||Scores on a scale||Standard Error|Least Squares Mean
2734631|NCT00986479|Secondary|Hamilton Depression Rating Scale-17 Item (HDRS) Total Score|Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734632|NCT00986479|Secondary|Hamilton Anxiety Rating Scale (HAM-A) Total Score.|Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.|60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.||||Units on a scale||Standard Error|Least Squares Mean
2734633|NCT00986479|Secondary|Scale for Suicide Ideation (SSI) Total Score.|Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734634|NCT00986479|Secondary|The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).|Response defined as a >= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Participants|||Number
2734635|NCT00986479|Secondary|The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).|Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score <10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Participants|||Number
2734636|NCT00986479|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2734637|NCT00986453|Secondary|Dissection Performance|Amount of tissue (g) removed over time (min)|Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||g/min|Participants|Standard Deviation|Mean
2734638|NCT00986453|Secondary|Amount of Tissue Removed||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||g|Participants|Standard Deviation|Mean
2734639|NCT00986453|Secondary|Operative Time||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||minutes|Participants|Standard Deviation|Mean
2734640|NCT00986453|Secondary|Estimated Blood Loss||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||mL|Participants|Standard Deviation|Mean
2734641|NCT00986453|Primary|Postoperative Pain|"The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.~Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days."|0 to 10 days postoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||units on a scale|Participants|Standard Deviation|Mean
2734642|NCT00986427|Secondary|Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)|Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.|Week 24||||participants|||Number
2734645|NCT00986427|Primary|Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2|"Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24.~The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24||||scores on a scale||Standard Deviation|Mean
2734646|NCT00986401|Secondary|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2734647|NCT00986401|Primary|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2734648|NCT00986362|Primary|Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).|Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.|Beginning of vitrectomy or after application of suction|Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups|||percentage of eyes|Participants||Number
2734649|NCT00986349|Other Pre-specified|Fasting Plasma Glucose Over Time for All Subjects||Baseline to 12 months post Device Explant|Subjects with a Successful Device Implant Procedure|||mmol/L||Full Range|Median
2734650|NCT00986349|Secondary|Total Weight Change (kg) at Week 52 Compared to Baseline Weight||Baseline to 52 weeks||||kg||Standard Deviation|Mean
2734651|NCT00986349|Primary|Change in Anti-diabetes Medications|"Medications were classified as increased if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as decreased if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as not assessable."|Baseline to 52 weeks||||Participants|||Count of Participants
2734652|NCT00986349|Primary|Assessment of Glycemic Control (HbA1c) Over Time|HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12|Baseline to 12 Months with device implanted|20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE|||HbA1c %||Full Range|Median
2734653|NCT00986310|Secondary|The Secondary End Point is, in the Group of Seizures With Desaturations Below 90%, a 30% Fluoxetine-related Improvement in the Oxygen Desaturation Nadir Relative to Placebo.||6 weeks|The study was completed and the PI has left the institution without entering the results information. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2734654|NCT00986310|Primary|The Primary End Point for This Study is a 50% Fluoxetine-related Reduction in the Number of Seizures With Associated Oxygen Desaturations Below 90% Compared With Placebo.||6 weeks|The study was completed and the PI has left the institution without entering the results information. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2734655|NCT00986258|Secondary|painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2734656|NCT00986258|Secondary|painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2734657|NCT00986258|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2734658|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone|Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 8 participants with previous hydromorphone treatment.|||Ratio|||Number
2734659|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Morphine|Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 14 participants with previous morphine treatment.|||Ratio|||Number
2734660|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Fentanyl|Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 22 participants with previous transdermal fentanyl treatment.|||Ratio|||Number
2734661|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 24 participants with previous buprenorphine treatment.|||Ratio|||Number
2734662|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 35 participants with previous oxycodone treatment.|||Ratio|||Number
2734663|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.~The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2734664|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 6|"Intention to treat (ITT).~For the sub-scores Overall Score and Pressing Pain there were only 60 participants with data available at Visit 6."|||units on a scale||Standard Deviation|Mean
2734665|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|Baseline|"Intention to treat (ITT).~For the sub-scores Overall Score and Pressing Pain there were only 69 participants with data available at baseline."|||units on a scale||Standard Deviation|Mean
2734666|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 Weeks)|"Intention to Treat (ITT).~For the sub-scores Role Emotional and Role Physical, there were only 91 participants with data available for the change of these sub-scores from baseline to visit 12."|||units on a scale||Standard Deviation|Mean
2734667|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 Weeks)|"Intention to treat (ITT).~For the sub-scores Role Emotional and Role Physical there were 98 participants, for sub-scores Physical Functioning, Vitality and Mental Health there were 99 participants, for sub-score General Health there were 100 participants with data available for the change of these sub-scores from baseline to visit 6."|||units on a scale||Standard Deviation|Mean
2734668|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT)|||participants|||Number
2734669|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT)|||participants|||Number
2734670|NCT00986258|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2734671|NCT00986258|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2734672|NCT00986258|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat|||units on a scale||Standard Deviation|Mean
2734673|NCT00986258|Primary|Number of Participants That Responded to Treatment|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).|||participants|||Number
2734674|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Dyskinesia|Patients who have Global Impression for Improvement to Severity of Dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia severity.|||participants|||Number
2734675|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Dyskinesia|Patients who have global impression for improvement to duration of dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia duration.|||participants|||Number
2734676|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation|Patients who have global impression for improvement to severity of motor fluctuation compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation severity.|||participants|||Number
2734677|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation|Patients who have global impression for improvement to duration of motor fluctuation|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation duration.|||participants|||Number
2734678|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement|Patients who have global impression for improvement for each dosing.|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression.|||participants|||Number
2734679|NCT00986245|Secondary|Adverse Events|Patients who have adverse events|After 8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||participants|||Number
2734680|NCT00986245|Secondary|Compliance|Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||percentage of used medication||Standard Deviation|Mean
2734681|NCT00986245|Secondary|Epworth Sleep Scale|"Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.~Range: 0~24 Higher values represent worse daytime-sleepiness."|8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
2734682|NCT00986245|Secondary|Early Morning Off Symptoms|"Sleep questionnaire 3 for early morning off symptoms Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
2734683|NCT00986245|Secondary|Nocturnal Off-symptoms|"Sleep questionnaire 2 for Nocturnal off-symptoms Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
2734684|NCT00986245|Secondary|Overall Quality of Sleep|"Sleep questionnaire 1 for Overall quality of sleep Visual analogue scale: 0~10 Higher values represent worse overall sleep quality."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
2734685|NCT00986245|Secondary|Hoehn and Yahr Stage|Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||Scores on a scale||Standard Deviation|Mean
2734686|NCT00986245|Secondary|Unified Parkinson's Disease Rating Scale, Part 3|"Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.~UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
2734687|NCT00986245|Primary|Patient Preference|Patient preference between once-daily and twice-daily regimen|After 16 weeks or at last visit for early completion|"Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover.~61 of participants completing period with study intervention."|||participants|||Number
2734688|NCT00986232|Secondary|Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2734689|NCT00986232|Secondary|Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2734690|NCT00986232|Secondary|Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2734691|NCT00986232|Secondary|Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2734692|NCT00986232|Secondary|Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)|Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination Visit 1 or Visit 2|All participants with follow-up for safety were included in the analysis.|||Participants|||Number
2734693|NCT00986232|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
2734694|NCT00986232|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL|Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
2734695|NCT00986232|Secondary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL|Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
2734696|NCT00986232|Primary|Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units|Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.|||Participants|||Number
2734697|NCT00986180|Secondary|Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain|50% response means >= 50% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Hours||95% Confidence Interval|Median
2734698|NCT00986180|Secondary|Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain|30% response means >= 30% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Hours||95% Confidence Interval|Median
2734699|NCT00986180|Secondary|Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event|Number of subjects that reported pruritus as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
2738720|NCT00958789|Secondary|Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-op, 1, 2, 5 years|||||||
2734704|NCT00986180|Secondary|Incidence of 50% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Participants|||Number
2734705|NCT00986180|Secondary|Incidence of 30% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Participants|||Number
2734706|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population with subject's satisfaction assessment at end of the study.|||Units on a Scale||Standard Deviation|Mean
2734707|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population.|||Units on a Scale|||Number
2734708|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population with subject's satisfaction assessment on Day 5.|||Units on a Scale||Standard Deviation|Mean
2734709|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population.|||Units on a Scale|||Number
2734710|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population with CGIC assessment.|||Units on a Scale||Standard Deviation|Mean
2734711|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.|||Units on a Scale|||Number
2734712|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/lst visit|Intent-To-Treat Population with PGIC assessment.|||Units on a Scale||Standard Deviation|Mean
2734713|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.|||Units on a Scale|||Number
2734714|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 10|Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734715|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734716|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734717|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||score of scale||Standard Deviation|Mean
2738967|NCT00957801|Primary|Hematocrit Measured on Treatment Day 1 (Baseline Study)|Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.|treatment day 1||||percent||Standard Deviation|Mean
2734718|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit|"Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles and numbness."|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734719|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5|"Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles and numbness."|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734720|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734721|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734722|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
2734723|NCT00986180|Secondary|SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5|Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 5|Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement|||Units on a Scale||Standard Deviation|Mean
2734724|NCT00986180|Secondary|Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days|Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
2734725|NCT00986180|Secondary|SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
2734726|NCT00986180|Secondary|SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
2734727|NCT00986180|Secondary|SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
2747758|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)|12 hours|Safety population|||% predicted||Full Range|Mean
2734728|NCT00986180|Secondary|SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
2734729|NCT00986180|Secondary|SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a scale||Standard Error|Least Squares Mean
2734730|NCT00986180|Secondary|SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a scale||Standard Error|Least Squares Mean
2734731|NCT00986180|Secondary|Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
2734732|NCT00986180|Primary|Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.|0 hour (prior to first dose) and 120 hours|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a scale||Standard Error|Least Squares Mean
2734733|NCT00986154|Secondary|Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment|Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.|12 months from time of randomization|Safety Analysis Set|||participants with an event|||Number
2734734|NCT00986154|Secondary|The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality||12 months from time of randomization|mITT Analysis set|||number of participants with event|||Number
2734735|NCT00986154|Primary|Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE|"Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.~Overall Study Period defined as The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."|12 months from time of randomization|(mITT) modified Intent To Treat Analysis Set|||number or participants with an event|||Number
2734736|NCT00986102|Secondary|Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734737|NCT00986102|Secondary|Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734738|NCT00986102|Secondary|Medical Resource Utilization|Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.|From Baseline (Day -1) upto the duration of hospital stay of a participant|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Days||Full Range|Median
2734739|NCT00986102|Secondary|Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit||Day 5 or Day 7 or Day 14|Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.|||Participants|||Number
2734740|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit||End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734741|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)||Day 5 or Day 7 or Day 14|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734756|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I|Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2|||ng/mL||Standard Deviation|Mean
2734742|NCT00986102|Primary|Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score|APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.|Baseline (Day -1)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734743|NCT00986102|Primary|Duration of Antibiotic Therapy|Duration of doripenem and duration of doripenem plus oral antibiotics therapy|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Days||Standard Deviation|Mean
2734744|NCT00986102|Primary|Number of Participants With Different Mode of Usage of Doripenem||5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734745|NCT00986102|Primary|Number of Participants With the Usage of Doripenem as Per the Approved Indication|Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2734746|NCT00985985|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs|All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.|Weekly assessments from first treatment dose up to 15 days after last treatment dose|Safety Population of this study consists of all randomized participants who have had study medication for at least once.|||Participants|||Number
2734747|NCT00985985|Secondary|Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.|Change in body weight was analyzed at Weeks 6, 12, and 24.|Baseline, Week 6, 12 and Week 24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point i.e. Week 6, Week 12 and Week 24. Missing values were not imputed.|||kilogram (kg)||Standard Deviation|Mean
2734748|NCT00985985|Secondary|Mean Daily Dose at Visit 4, 5, 6, 7 and 10|Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.|Weeks 1-2, 3-4, 5-6, 7-12 and 13-24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point. Missing values were not imputed.|||Number of lozenges||Standard Deviation|Mean
2734749|NCT00985985|Secondary|Mean Score of Relief of Craving/ Total Withdrawal Symptoms|The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.|Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6|Analysis was carried out per FAS population, which consisted of all randomized subjects who have had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the number of participants analyzed (n) for this outcome measure. Missing values were not imputed.|||Score on a scale||Standard Deviation|Mean
2734750|NCT00985985|Secondary|Proportion of Participants With Seven Day Point Prevalence Abstinence|Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.|Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24|Analysis was carried out per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
2734751|NCT00985985|Secondary|Rate of Long-term Successful Smoking Cessation at Week 24|Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.|From Week 6 to Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
2734752|NCT00985985|Secondary|Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24|Continuous abstinence was verified by measurement of CO breath levels.|From baseline to Week 12 and Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
2734753|NCT00985985|Primary|Rate of Successful Smoking Cessation at Week 6|Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.|From baseline to Week 6|Analysis was considered per Full Analysis Set (FAS) population. FAS population consisted of all randomized participants who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
2734754|NCT00985959|Secondary|Median Time to First Response - Phase II|Time to first response is the duartion of time required to achieve first response to treatment|up to 54 weeks|Full analysis set: All participants who received at least one dose of the study medication.|||Days||95% Confidence Interval|Median
2734755|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I|Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2|||ng/mL||Standard Deviation|Mean
2747759|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose|12 hours|Safety population|||Liters||Full Range|Mean
2734757|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2|||ng/mL||Standard Deviation|Mean
2734758|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)|Day 25 of Cycle 1|Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population|||ng/mL||Standard Deviation|Mean
2734759|NCT00985959|Primary|Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II|Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions|54 weeks|Full analysis set: All participants who received at least one dose of the study medication.|||Participants|||Number
2734760|NCT00985959|Primary|Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)|Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1|6 weeks|Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I|||Participants|||Number
2734761|NCT00985946|Secondary|Evaluate the Overall Survival of Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat||Up to 5 years||||months||90% Confidence Interval|Median
2734762|NCT00985946|Secondary|Delineate the Expression of Notch 1 in Neuroendocrine Tumor Samples Before and During Treatment With Panobinostat|The expression of Notch 1 in neuroendocrine tumor samples will be evaluated prior to Cycle 1 Day 1 dose and at the end of Cycle 2 of treatment of treatment.|Pre-treatment and up to week 12|Data to delineate the expression of Notch 1 in neuroendocrine tumor samples was not collected. The question regarding the role of Notch1 in well-differentiated NET remains unanswered.||||||
2734763|NCT00985946|Secondary|Evaluate the Time to Progression for Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat||Up to 5 years||||months||90% Confidence Interval|Median
2734764|NCT00985946|Secondary|Number of Participants With Toxicities|Evaluate the toxicity and tolerability of panobinostat in the patient population|up to 5 years||||participants|||Number
2734765|NCT00985946|Primary|Tumor Response Rate of Patients With Gastrointestinal Neuroendocrine Tumors Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Confirmed anti-tumor response rate will be validated by the Response Evaluation Criteria in Solid Tumors (RECIST). All participants included in the study will be assessed for response to the proposed panobinostat treatment, even if there are protocol treatment deviations. Each participant will be assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death from malignant disease, early death from toxicity, early death because of other cause, or unknown.|every 8 weeks, up to 5 years||||participants|||Number
2734766|NCT00985829|Other Pre-specified|Past Medical History of Radiotherapy|past medical history of radiotherapy to the site of tumor before its appearance(for another reason)|baseline||||lesions|||Number
2734767|NCT00985829|Other Pre-specified|BCC Type|superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)|baseline||||lesions|||Number
2734768|NCT00985829|Other Pre-specified|Location of Lesion||baseline||||lesions|||Number
2734769|NCT00985829|Other Pre-specified|Cosmetic Result|excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration|1 month after termination of treatment course (with an average of 6 months after initiation of PDT)|cosmetic result was assessed among patients with complete response|||lesions|||Number
2734770|NCT00985829|Secondary|Histologic Resolution of Lesion|disappearance of the lesion in histologic examination|immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)|from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically.|||lesions|||Number
2734771|NCT00985829|Primary|Clinical Response to Photodynamic Therapy|categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced|immediately after termination of treatment course (with an average of 5 month after initiation of PDT)||||lesions|||Number
2734772|NCT00985790|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs).|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2734773|NCT00985790|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2747760|NCT00893971|Primary|ECG Change From Baseline|Change from baseline for ECG parameters 12-hours post-dose|12 hours|Safety population|||ms||Full Range|Mean
2734774|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.|During the 28-day follow-up period (Days 0 to 27) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2734775|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.|||Participants|||Count of Participants
2734776|NCT00985790|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.|||Participants|||Count of Participants
2734777|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2734778|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2734779|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold change||95% Confidence Interval|Geometric Mean
2734780|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold change||95% Confidence Interval|Geometric Mean
2734781|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2734792|NCT00985751|Secondary|Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||LU/mL||95% Confidence Interval|Geometric Mean
2734782|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2734783|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2734784|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Participants|||Count of Participants
2734785|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and Day 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2734786|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2734787|NCT00985790|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.|At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2734788|NCT00985751|Secondary|Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity|Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2734789|NCT00985751|Secondary|Antibody Concentrations to Protein D (Anti-PD)|Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||LU/mL||95% Confidence Interval|Geometric Mean
2734790|NCT00985751|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2734791|NCT00985751|Secondary|Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2734793|NCT00985751|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2734794|NCT00985751|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|During the 31-day (Days 0-30) follow-up period after the booster dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2734795|NCT00985751|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|During the 31-day (Days 0-30) follow-up period after each primary dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2734796|NCT00985751|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2734797|NCT00985751|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2734798|NCT00985751|Primary|Number of Subjects With Fever > 40.0°C (Rectal Temperature)|The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.|Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2734799|NCT00985751|Primary|Number of Subjects With Fever > 40.0°C (Rectal Temperature)|The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.|Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2734800|NCT00985738|Primary|To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.|The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.|24 Months|"The study was terminated. Study end points were not reached. No data were collected"||||||
2734801|NCT00985725|Secondary|Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9|The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.|Baseline and week 9|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.|||Scores on a scale||Standard Deviation|Mean
2734802|NCT00985725|Secondary|Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF|The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.|Baseline and week 9|SAS|||Scores on a scale||Standard Deviation|Mean
2734803|NCT00985725|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Baseline and week 11|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.|||Scores on a scale||Standard Deviation|Mean
2734817|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24|Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.|||number of events per 30 days||Standard Deviation|Mean
2734804|NCT00985725|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint|The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||Scores on a scale||Standard Deviation|Mean
2734805|NCT00985725|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 9|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||Scores on a scale||Standard Deviation|Mean
2734806|NCT00985725|Secondary|Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|Only the females from the SAS population were used and not all of them completed this outcome assessment.|||Scores on a scale||Standard Deviation|Mean
2734807|NCT00985725|Secondary|Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.|||Scores on a scale||Standard Deviation|Mean
2734808|NCT00985725|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint|The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||Scores on a scale||Standard Error|Least Squares Mean
2734809|NCT00985725|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 9|FAS|||percentage of participants|||Number
2734810|NCT00985725|Secondary|Percent of Participants With CGI-S at up to 9 Weeks/Endpoint|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||percentage of participants|||Number
2734811|NCT00985725|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS|||percentage of participants|||Number
2734812|NCT00985725|Secondary|Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint|This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better.|Baseline and up to 9 weeks/Endpoint|FAS|||Response scores||Standard Deviation|Mean
2734813|NCT00985725|Secondary|Change From Baseline in BRIEF-A T-scores at Week 9, LOCF|BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|FAS|||T-scores||Standard Error|Least Squares Mean
2734814|NCT00985725|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 9|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2734815|NCT00985725|Primary|Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.|||T-scores||Standard Error|Least Squares Mean
2734816|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24|Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.|||number of events per 30 days||Standard Deviation|Mean
2734818|NCT00985712|Secondary|Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint|IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.|Week 24|Participants in full analysis population set who had Week 24 measurements.|||units on a scale||95% Confidence Interval|Least Squares Mean
2734819|NCT00985712|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint||Week 24|Participants in full analysis population set who had Week 24 measurements.|||percentage of participants|||Number
2734820|NCT00985712|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.|Baseline, Week 24|Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2734821|NCT00985686|Secondary|Spiritual Involvement and Belief Scale (SIBS)|Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.|At 8 week intervals over a 24 week period|||||||
2734822|NCT00985686|Secondary|Spiritual Well-Being Scale (SWBS)|Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.|At 8 week intervals over a 24 week period|||||||
2734823|NCT00985686|Secondary|Profile of Mood States (POMS)|Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.|At 8 week intervals over a 24 week period|||||||
2734824|NCT00985686|Secondary|Six Factor Self-Concept Scale|Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.|At 8 week intervals over a 24 week period|||||||
2734825|NCT00985686|Secondary|Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)|Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.|At 8 week intervals over a 24 week period|||||||
2734826|NCT00985686|Primary|Hamilton Depression Rating Scale (HAMD)|Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.|At 8 week intervals over a 24 week period||||units on a scale||Standard Error|Mean
2734827|NCT00985686|Primary|Children's Depression Rating Scale Revised (CDRS-R)|Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.|At 8 week intervals over a 24 week period||||units on a scale||Standard Error|Mean
2734828|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after dose 1 vaccination|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Titers||95% Confidence Interval|Geometric Mean
2734829|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734830|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Fold||95% Confidence Interval|Mean
2734839|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against A/California Strain.|Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Fold||95% Confidence Interval|Mean
2734831|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Fold||95% Confidence Interval|Mean
2734832|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after the first dose|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Subjects|||Number
2734833|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
2734834|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Subjects|||Number
2734835|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
2734836|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Fold||95% Confidence Interval|Mean
2734837|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
2734838|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
2735018|NCT00984620|Primary|Virological Response at Week 28 (W28VR)|Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.|28 weeks|Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.|||participants|||Number
2734840|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against A/California Strain.|Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
2734841|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against A/ California Strain.|"Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.~Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer"|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
2734842|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Titers||95% Confidence Interval|Geometric Mean
2734843|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|On Days 0, 21, 42 and 63|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734844|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734845|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734846|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734847|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734859|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
2747761|NCT00893971|Primary|ECG Change From Baseline|Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)|12 hours|Safety population|||bpm||Full Range|Mean
2734848|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the pandemic vaccine (at Day 63)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734849|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734850|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734851|NCT00985673|Secondary|Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0.~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.||||||
2734852|NCT00985673|Secondary|Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.~Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.||||||
2734853|NCT00985673|Secondary|Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.~Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.||||||
2734854|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
2734855|NCT00985673|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|"The day 329 was the last contact day with the subjects reporting serious adverse events.~SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects."|During the entire study period (Days 0-329).|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
2734856|NCT00985673|Secondary|Number of Subjects Reporting Potential Immune Diseases (pIMDs).|The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-406).|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
2734857|NCT00985673|Secondary|Number of Subjects Reporting Medically Attended Visits (MAEs).|The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Days 0-368).|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
2734858|NCT00985673|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 84-day (Days 0-83) post-vaccination period.|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
2734860|NCT00985673|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
2734861|NCT00985673|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
2734862|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
2734863|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
2734864|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.~Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.|||Number of T cells/million||Standard Deviation|Mean
2734865|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.~Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.|||Number of T cells/million||Standard Deviation|Mean
2734866|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734867|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (at Day 42).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2734868|NCT00985543|Secondary|Adverse Events|Number of reported adverse events, severity of adverse events and relationship to study drug was assessed by questions, physical examination and laboratory parameters. Adverse event data was used to assess the safety and tolerability of low lopinavir/ritonavir doses.|Up to 11 weeks from screening to final study visit|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).|||number of adverse events|||Number
2734869|NCT00985543|Primary|Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h).|Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.|at the end of each 7-day dosing phase|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).|||ng.h/mL||90% Confidence Interval|Geometric Mean
2734880|NCT00985504|Secondary|Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8|RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline at and least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734870|NCT00985517|Primary|"Phase 1 and Phase 2: Change From Baseline in Motor Examination Part III Total Score in the Off Condition for the CERE-120 Group as Compared to the Sham Surgery Control Group at the Last Double-blind Assessment."|"UPDRS is a tool to evaluate the impact of symptomatic and potential disease modifying treatments. Part III focuses on 14 motor functions, assessing each on a scale from 0 (normal) to 4 (severe) with total score 0 - 56. The 5 Feb 2003 version of the UPDRS Rating was used in this trial. The total score is the sum of 14 motor functions. Change from baseline in total score is reported.~The last double blind assessment for each subject is defined as the most recent assessment at the time when the final randomized subject completes the Month 15 Visit. The length of the double-blind follow-up period for each subject ranged from 15 to 24 months, depending on the enrollment rate."|Baseline, Months 15, 18, 21 and 24||||score on a scale||Full Range|Mean
2734871|NCT00985517|Primary|Number of Participants Who Received CERE-120 Treatment|Number of Participants who received CERE-120 Treatment|5 years|Phase 1: Cohort 1, Phase 1: Cohort 2, Phase 2: CERE-120, Phase 2: Sham Surgery|||Participants|||Count of Participants
2734872|NCT00985504|Secondary|Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks|Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion.|Baseline through 8 weeks|All randomized participants.|||percentage of participants|||Number
2734873|NCT00985504|Secondary|Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks|The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored).|Baseline through 8 weeks|Number of participants in each treatment group having time to relapse plus the participants censored. Duloxetine had 200 participants censored and escitalopram had 199 participants censored.|||days|||Number
2734874|NCT00985504|Secondary|Percentage of Participants Who Relapsed During 8 Weeks|Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||percentage of participants|||Number
2734875|NCT00985504|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8|The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734876|NCT00985504|Secondary|Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8|"The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 2 (normal) to 6 (totally absent). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline."|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734877|NCT00985504|Secondary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8|MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734878|NCT00985504|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8|The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734879|NCT00985504|Secondary|Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8|The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit.|8 weeks|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2734890|NCT00985465|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the first vaccination up to one month (31 days) after the last vaccination for each subject|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734881|NCT00985504|Secondary|Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8|AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734882|NCT00985504|Primary|Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8|The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2734883|NCT00985491|Secondary|Improvement in Type 2 Diabetic Status|Subjects who achieved HbA1c reduction of 0.5%|12 months|7 subjects were enrolled that had Type 2 Diabetes; endpoint evaluated subjects who achieved HbA1c reduction of 0.5%|||% of subjects with T2DM|||Number
2734884|NCT00985491|Primary|Assessment of % Excess Weight Loss|Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as [(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)] * 100).|12 months||||%EWL||Standard Error|Mean
2734885|NCT00985465|Secondary|Concentrations of Antibodies Against Protein D (PD)|Concentrations of antibodies against protein D (PD) were determined by ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is ≥ 100 ELISA units per milliliter (EL.U/mL).|Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2734886|NCT00985465|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and Opsono-19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.|Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2734887|NCT00985465|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.|Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2734888|NCT00985465|Secondary|Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.|Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2734889|NCT00985465|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). Pneumococcal serotype specific total immunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.|Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2734891|NCT00985465|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0-Day 30) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734892|NCT00985465|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4 days (Day 0-Day 3) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734893|NCT00985465|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within 4 days (Day 0-Day 3) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734894|NCT00985465|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4 days (Day 0-Day 3) after the booster dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734895|NCT00985465|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within 4 days (Day 0-Day 3) after the booster dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734896|NCT00985465|Primary|Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)|The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.|Within 31 days (Day 0-Day 30) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2734897|NCT00985439|Primary|Total Patient Pain Relief Over 0 to 12 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|12 hours.||||units on a scale||95% Confidence Interval|Least Squares Mean
2734898|NCT00985257|Primary|Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.|1-2 hours|To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.|||percent of blood glucose results|Participants||Number
2734899|NCT00985231|Secondary|Subjective Ratings of Eye Strain|Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always|2 week visit|All Eligible, Dispensed Eyes, CISS Composite Score|||CISS Composite Score||Standard Deviation|Mean
2734900|NCT00985231|Primary|Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.|Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.|2 weeks|All Eligible, Dispensed Eyes with non-missing scores|||eyes|Participants||Number
2734901|NCT00985192|Secondary|Biomarker Correlations: Time to Progression|Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"|||months||95% Confidence Interval|Median
2734902|NCT00985192|Secondary|Biomarker Correlations: Progression Free Survival|Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"|||months||95% Confidence Interval|Median
2739123|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day prior to drug administration 2||||score on a scale||Standard Error|Mean
2734903|NCT00985192|Secondary|Observed Biomarkers|Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"|||number of tissue blocks|||Number
2734904|NCT00985192|Secondary|Efficacy in Terms of Progression Free Response|Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan-Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.|evry 3 months in year 1, every 6 months after that||||months||95% Confidence Interval|Median
2734905|NCT00985192|Secondary|Overall Survival|Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan-Meier method.|2.5 year||||months||95% Confidence Interval|Median
2734906|NCT00985192|Primary|Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.|Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.||||percent subjects with disease control||95% Confidence Interval|Number
2734907|NCT00985166|Primary|Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
2734908|NCT00985166|Primary|Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||ELISA AB units/mL||95% Confidence Interval|Geometric Mean
2734909|NCT00985166|Primary|Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2734910|NCT00985166|Primary|Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2734911|NCT00985153|Primary|Number of Participants With Serious Vaccine-related CAEs|Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination|All subjects with follow-up for safety were included in the analysis.|||Participants|||Number
2734912|NCT00985153|Primary|Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||ELISA AB units||95% Confidence Interval|Mean
2734913|NCT00985153|Primary|Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||ELISA AB units||95% Confidence Interval|Mean
2734914|NCT00985153|Primary|Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Mean
2734915|NCT00985153|Primary|Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer < 1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||gpELISA||95% Confidence Interval|Mean
2734916|NCT00985153|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
2734917|NCT00985153|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
2734918|NCT00985153|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
2734919|NCT00985153|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||Participants|||Number
2734920|NCT00985140|Primary|Clinical Response Rate|"After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy.~The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease."|1 year|All patients who completed treatment.|||participants|||Number
2734921|NCT00985114|Primary|Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.||6 months||||% of participants|||Number
2734922|NCT00985088|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Results were tabulated for subjects aged between 18-64 years and older (>64y).|During the entire study period (from Day 0 to Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2734923|NCT00985088|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18-64 years and older (>64y).|Within the 84-day (Days 0-83) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2734924|NCT00985088|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2734925|NCT00985088|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Results were tabulated for subjects aged between 18-64 years and above 65 years (+65y).|Days 0 to 365|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2734926|NCT00985088|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any MAE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18 and 64 years and older (>64y).|Days 0 to 385|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2734927|NCT00985088|Secondary|Number of Subjects With Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.|At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2734928|NCT00985088|Secondary|Number of Subjects With Abnormal Biochemical and Haematological Levels|"Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC].~Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter."|At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age|The analysis was performed on the Total Vaccinated cohort included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2754582|NCT00844831|Secondary|Small Bowel and Colon Transit Time by SmartPill® Transit Study||28 days|We were unable to obtain the smart pills for this section of the protocol.||||||
2734929|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).|During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in. This analysis focused on subjects who received an additional dose of GSK2340273A F2 vaccine from GSK2340273A F2_1D Group.|||Participants|||Count of Participants
2734930|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).|During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in. This analysis focused on subjects who received an additional dose of GSK2340273A F2 vaccine from GSK2340273A F2_1D Group.|||Participants|||Count of Participants
2734931|NCT00985088|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
2734932|NCT00985088|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
2734933|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
2734934|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
2734935|NCT00985088|Secondary|Adjusted GMT Ratios for A/California Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F1_1D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine vs. GSK2340273A F1_1D vaccine|||Titer|||Number
2734936|NCT00985088|Secondary|Adjusted GMT Ratios for A/California Virus Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F2 and GSK2340273A F2.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine versus GSK2340273A F2 vaccine|||Titer|||Number
2735469|NCT00981253|Secondary|Change in High-sensitivity C-Reactive Protein|High-sensitivity C-reactive protein was quantified by ELISA. Values >10 mg/L were truncated at 10 to account for acute inflammatory processes that may have skewed the distribution of this blood marker.|Baseline; 12 weeks||||mg/L||95% Confidence Interval|Least Squares Mean
2734937|NCT00985088|Secondary|Adjusted GMT Ratios of A/California Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F3_2D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine versus GSK2340273A F3 vaccine|||Titer|||Number
2734938|NCT00985088|Secondary|Adjusted GMT Ratios of A/California Virus Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and the GSK2340273A F1_1D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine vs GSK2340273A F1_1D vaccine|||Titer|||Number
2734939|NCT00985088|Secondary|Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F1 and GSK2340273A F2.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine versus GSK2340273A F2 vaccine|||Titer|||Number
2734940|NCT00985088|Secondary|Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and GSK2340273A F3_2D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine versus GSK2340273A F3 vaccine|||Titers|||Number
2734941|NCT00985088|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2734942|NCT00985088|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734943|NCT00985088|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734944|NCT00985088|Secondary|Titers for HI Antibodies Against the A/California Virus Strain|Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Titers||95% Confidence Interval|Geometric Mean
2734945|NCT00985088|Secondary|Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2735019|NCT00984594|Secondary|Lysholm Score at 24 Months|The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
2755463|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 8 postop||||total number of cells * 10^5/mL||Standard Deviation|Mean
2734946|NCT00985088|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2734947|NCT00985088|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734948|NCT00985088|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734949|NCT00985088|Secondary|Titers for HI Antibodies Against the A/California Virus Strain|Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Titers||95% Confidence Interval|Geometric Mean
2734950|NCT00985088|Secondary|Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734951|NCT00985088|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2734952|NCT00985088|Secondary|Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734953|NCT00985088|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734954|NCT00985088|Secondary|Titers for HI Antibodies Against A/California Strain|Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Titers||95% Confidence Interval|Geometric Mean
2734955|NCT00985088|Secondary|Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734956|NCT00985088|Primary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (>64y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2734957|NCT00985088|Primary|Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (>60y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2734958|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734959|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734960|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (>60y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734961|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (>60y).|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734962|NCT00985088|Primary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (>64y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734963|NCT00985088|Primary|Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (>60y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734964|NCT00985088|Primary|Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2735020|NCT00984594|Secondary|Magnetic Resonance Imaging (MRI) Results|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
2734965|NCT00985088|Primary|Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734966|NCT00985088|Primary|Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects > 60 years.|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734967|NCT00985088|Primary|Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (>) 60 years.|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on Days 0, 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
2734968|NCT00985010|Secondary|Manganese Levels|From encephalopathic patients, we took individual blood samples, analyzed in the biochemistry laboratory at the National Institute of Neurology and Neurosurgery, Mexico, City, with a graphite furnace atomic absorption spectrometer, according to the technique reported by Pleban.|Up to six months we followed the recruited patients to determine who were still alive|All patients attended at the Internal Medicine Service with Hepatic Encephalopathy were included. The analysis was per protocol.|||μg/L||Standard Deviation|Mean
2734969|NCT00985010|Primary|Clinical Evolution|Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room|six months|We made a clinical follow up from nine encephalopathic patients. After six months we studied the differences in Mn, hemoglobin, etc., between those patients still alive and those who died.|||participants|||Number
2734970|NCT00984867|Secondary|Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline|To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2734971|NCT00984867|Secondary|Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise|To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2734972|NCT00984867|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg|To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full analysis set, participants with baseline SBP>=130mmHg and Week 8 (LOCF) value|||mmHg||95% Confidence Interval|Least Squares Mean
2734973|NCT00984867|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2734974|NCT00984867|Secondary|Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%|To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full analysis set, participants with baseline HbA1c >=8% and Week 24 (LOCF) value|||Percent||95% Confidence Interval|Least Squares Mean
2734975|NCT00984867|Secondary|Adjusted Mean Change in Body Weight|To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2734976|NCT00984867|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
2734977|NCT00984815|Secondary|Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.|Baseline and 54 Weeks|55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.|||Scores on a scale||Standard Deviation|Mean
2755464|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 5 postop||||total number of cells * 10^5/mL||Standard Deviation|Mean
2734978|NCT00984815|Secondary|Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.|||Scores on a scale||Standard Deviation|Mean
2734979|NCT00984815|Primary|Number of Participants With Treatment Emergent Adverse Events||54 weeks|All participants enrolled and who received at least one dose of study drug comprised the Safety Population.|||participants|||Number
2734980|NCT00984815|Secondary|Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.|||Scores on a scale||Standard Deviation|Mean
2734981|NCT00984698|Primary|Depression|Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point~PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point"|||units on a scale||Standard Deviation|Mean
2734982|NCT00984698|Secondary|PTSD|Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment~PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment"|||units on a scale||Standard Deviation|Mean
2734983|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From Baseline to Last Treatment Week in the SOBDA Score Based on Forced Expiratory Volume in One Second (FEV1) Change From Baseline of 50 Milliliters (mL) to <100 mL|"FEV1 response was rated as 1=No change or worse (i.e., change of <50 mL); 2=Better (i.e., change of 50 to <100 mL); 3=Much better (i.e., change of >=100 mL). The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on study assessment (FEV1) scores pre-specified as better or demonstrating meaningful improvement."|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||mL||Standard Deviation|Mean
2734984|NCT00984659|Primary|"SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CRQ-SAS Dyspnea Domain (DD) Response Rated as Better"|"The threshold of response (TOR) is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit. The TOR was evaluated as the change from Baseline in the SOBDA score based on CRQ-SAS scores pre-specified as better or demonstrating meaningful improvement. The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing)."|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
2734985|NCT00984659|Primary|"SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CGI-C Response Rated as Better"|"The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on CGI-C scores pre-specified as better or demonstrating meaningful improvement. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse, 2, worse; 3, no change; 4, better; 5, much better."|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
2734999|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Clinician Global Assessment of Dyspnea Severity (CGI-S) Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure the required information and was assessed by examining the relationship between the SOBDA score with the CGI-S score. Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other. Clinicians were asked to assess the severity of the participant's dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe).|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.|||Spearman rank correlation coefficient|||Number
2734986|NCT00984659|Primary|"SOBDA Threshold for Response Assessed as Mean Change From the Previous Week's SOBDA Score Based on a Participant-completed PGAC Score Rated of Better"|"Changes from Baseline in the SOBDA score for responders (Rs) and non-responders (NRs) (using the PGAC assessment; 1 [much worse] to 5 [much better]), together with the cumulative proportions of Rs and NRs, was used to establish the threshold for defining SOBDA questionnaire Rs. The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on PGAC scores pre-specified as better or demonstrating meaningful improvement."|Baseline (last week of the 2-week Run-in Period) and Weeks 1, 2, 3, 4, 5, and 6 (6-week Treatment Period)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||scores on a scale||Standard Deviation|Mean
2734987|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by Physician-completed mMRC and Participant-completed mMRC Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The mMRC ranges from 0 (no breathlessness except with strenous exercise) to 4 (too breathless to leave the house; breathless when dressing/undressing) and is completed by the clinician or the participant as indicated. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the Physician-completed (Ph-C) and Participant-completed (Pa-C) mMRC conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
2734988|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CRQ-SAS Dyspnea Domain (DD) Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes of responders (Rs) versus non-responders (NRs). The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing). Changes in mean SOBDA scores during the last treatment week in Rs and NRs using definitions based on the CRQ-SAS DD conducted at Visit 3/PD were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
2734989|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CGI-C Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the CGI-C conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||scores on a scale||Standard Deviation|Mean
2734990|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Physician-completed and Participant-completed mMRC Response at Visit 3/PD|A Physician-completed and Participant-completed mMRC responder was defined as a participant who had a score decrease of one unit or more between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had the same score or an increase in score.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||participants|||Number
2734991|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by CRQ-SAS Dyspnea Domain Response at Visit 3/PD|A CRQ-SAS dyspnea domain responder was defined as a participant who had a score increase of 0.5 units or more for the dyspnea domain of the CRQ-SAS between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had a decrease in the score, or an increase of less than 0.5 units.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||participants|||Number
2734992|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Clinician Global Impression of Change Question (CGI-C) Response at Visit 3/PD|"Clinicians were asked to provide their clinical impression regarding change in the participant's shortness of breath by CGI-C. This was evaluated on a 1-5 Likert scale: 1 (much worse) to 5 (much better), with 3 being no change. A CGI-C responder was defined as a participant who had a response of better (4) or much better (5), and a non-responder was defined as a participant who had a response of much worse (1), worse (2), or no change (3)."|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||participants|||Number
2755465|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Baseline||||total number of cells * 10^5/mL||Standard Deviation|Mean
2734993|NCT00984659|Primary|Change From the Previous Week to the Current Week's SOBDA Score by Participant-completed PGAC Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/PD (End of the 6-week Treatment Period or PD)|"Responsiveness reflects the ability of the SOBDA questionnaire to detect change under conditions of known change. Responders (Rs)=participants (par.) with a rating of better/much better (score of 4/5) on the PGAC (range; 1 [much worse] to 5 [much better]) at the relevant week; NRs=par. with a response of much worse, worse, or no change (score of 3). Mean difference between Rs and NRs in the change from the previous week to the current week's SOBDA score was calculated. For Visit 3/PD, the change from Baseline to the last treatment week's SOBDA score for Rs and NRs was calculated."|Baseline; Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||scores on a scale||Standard Deviation|Mean
2734994|NCT00984659|Primary|Participants (Par.) Classified as Responders/Non-responders According to the Patient Global Assessment of Change (PGAC) Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/Premature Discontinuation (PD) (the End of the 6-week Treatment Period or PD)|"The PGAC is par. completed on a 1-5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Responders were defined as par. with a rating of better or much better (score of 4 or 5) on the PGAC at the relevant week; non-responders were defined as par. with a response of much worse, worse, or no change on the PGAC. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect."|Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|Modified Intent-to-Treat (MITT) Population: all participants randomized to treatment who received at least one dose of study medication. Analyses were conducted on data available for each specified time point.|||participants|||Number
2734995|NCT00984659|Primary|Known Group Validity (KGV) for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of CGI-S Scores at Visit 2|SOBDA KGV refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the CGI-S score. Clinicians were asked to assess the severity of the participant's dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe). KGV was confirmed if the SOBDA score increased with increasing values of CGI-S, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatement on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the CGI-S score at Visit 2 were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2734996|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Participant-completed (ParC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the ParC mMRC. The participant rated the degree of his/her dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of ParC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Participant-completed mMRC score at Visit 2 were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2734997|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Physician-completed (PyC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the PyC mMRC. The physician rated the degree of the participant's dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of PyC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Physician-completed mMRC score at Visit 2 were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2734998|NCT00984659|Primary|Convergent Validity (CV) for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) Dyspnea Domain Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the CRQ-SAS dyspnea domain score. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 will occur if the data from the 2 variables lie exactly on a line. The CRQ is a 20-item instrument measuring 4 domains (each measured on a scale of 1 [maximum impairment] to 7 [no impairment]) of functioning: mastery, fatigue, emotional function, and dyspnea.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.|||Pearson's correlation coefficient|||Number
2735016|NCT00984620|Secondary|Virological Response at Week 24 (W24VR)|virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.|24 weeks|PPS|||participants|||Number
2735017|NCT00984620|Secondary|Rapid Virological Response at Week 4 (RVR)|Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.|4 weeks|PPS|||participants|||Number
2735099|NCT00983983|Secondary|Rate of Change in ALSFRS-R in Units/Month|Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.|Over 5 months||||units on a scale/month||95% Confidence Interval|Mean
2735000|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as Correlations of the Baseline SOBDA Score With Participant-completed Modified Medical Research Council (mMRC) and Physician-completed mMRC Scores at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the participant/physician-completed mMRC Dyspnea Scale assessments. The physician/participant rated the degree of the participant's dyspnea (trouble breathing) on the 5-point mMRC scale (0, none; 4, very severe). Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed. One participant who rated their own trouble breathing had missing data for the physician assessment.|||Spearman rank correlation coefficient|||Number
2735001|NCT00984659|Primary|Test-retest Reliability (T-RR) of SOBDA Scores Measured as the Difference in the SOBDA Weekly Score Between Week 1 and Week 2 of the 2-week Run-in Period|T-RR=stability during repeat measures over time in a stable population. SOBDA score was determined by the 13-item (it.) scoring algorithm, assigning a weekly mean score of 1-4 (higher scores=more severe breathlessness with daily activities) based on the mean of 7 days of data (or >=4 days). Daily total score is computed from the mean of the participant's (par.) scores on the 13 it. (>=7 it. must have non-missing responses). Only scores of stable par. (indicating no change [score=3] on the par.-completed Patient Global Assessment of Change [PGAC]; 1 [ much worse] to 5 [much better]) were used.|Week 1 and Week 2 of the 2-week Run-in Period|Run-in Population. Data from participants with weekly SOBDA scores at Week 1 and Week 2 of the 2-week Run-in Period and reporting no change on the second weekly PGAC were analyzed.|||scores on a scale||Standard Deviation|Mean
2735002|NCT00984659|Primary|Internal Consistency (IC) of the Shortness of Breath With Daily Activities (SOBDA) Questionnaire in Participants With Chronic Obstructive Pulmonary Disease (COPD) Assessed as Cronbach's Alpha Value|Cronbach's alpha (CA) is a measure of the IC of the 13-item SOBDA questionnaire (completed via electronic diary by a sample of participants). It is the ratio of the variance (var.) of the sum of the individual scores and the var. of the total score. The var. of the sum of a group of independent variables is the sum of their var.; thus, if the variables are positively correlated, the var. of the sum will be increased. If the items making up the score are identical and so perfectly correlated, CA=1. If the items are independent, CA=0. Higher scores indicate a more reliable (precise) instrument.|Day 1 of the 2-week Run-in Period|Run-in Population: all participants who completed Visit 2 (Day 1 of Treatment Period), including those who were not randomized, were randomized but did not receive a dose of study medication, and those who were randomized and received study medication. Participants with a score for each SOBDA item on Day 1 of the 2-week Run-in Period were analyzed.|||ratio of variance|||Number
2735003|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)|Change from baseline (CFB) in PT-INR (ratio).|baseline and 48 weeks|TS|||ratio||Standard Deviation|Mean
2735004|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)|Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.|baseline and 48 weeks|TS|||U/L||Standard Deviation|Mean
2735005|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)|Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.|baseline and 48 weeks|TS|||mmol/L||Standard Deviation|Mean
2735006|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)|Change from baseline (CFB) in Platelets and white blood cells.|baseline and 48 weeks|TS|||10^9 cells/L||Standard Deviation|Mean
2735007|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)|Change from baseline (CFB) in haematocrit and Eosinophils.|baseline and 48 weeks|TS|||% of laboratory test substance||Standard Deviation|Mean
2735008|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)|Change from baseline (CFB) in Red blood cells.|baseline and 48 weeks|TS|||10^12 cells/L||Standard Deviation|Mean
2735009|NCT00984620|Secondary|Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination|No number of participants with clinically relevant abnormalities in vital signs and physical examination.|48 weeks|TS|||participants with abnormality|||Number
2735010|NCT00984620|Secondary|Laboratory Test Abnormalities and Study Medication Tolerabilities|Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.|48 weeks|Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.|||participants|||Number
2735011|NCT00984620|Secondary|Time to Reach a Plasma HCV RNA Level BLD While on Treatment|Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment|48 weeks|PPS|||week||Inter-Quartile Range|Median
2735012|NCT00984620|Secondary|Viral Load (HCV RNA) at All Visits During Treatment and Follow-up|Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.|From baseline to 72 weeks|PPS|||IU/mL||Standard Deviation|Mean
2735013|NCT00984620|Secondary|Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy|Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.|72 weeks|PPS|||participants|||Number
2735014|NCT00984620|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.|up to 48 weeks|PPS|||participants|||Number
2735015|NCT00984620|Secondary|Virological Response at Week 36 (W36VR)|Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.|36 weeks|PPS|||participants|||Number
2735021|NCT00984594|Secondary|IKDC Assessment|The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
2735022|NCT00984594|Secondary|Current Health Assessment (CHA)|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
2735023|NCT00984594|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
2735024|NCT00984568|Primary|Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50|Response at Week 4 was defined as a minimum decrease from baseline in Mayo score of 3 points and 30%. Steroid-free remission at Week 50 was defined as a total Mayo score (including endoscopic assessment) of 2 points or lower and no individual subscore exceeding 1. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician's global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst).|Week 50|The FAS consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2735025|NCT00984568|Secondary|Number of Participants Achieving Treatment Response|"Response was defined as a minimum decrease from baseline in total Mayo score of 3 points and 30% up to and including 4 weeks after the start of treatment. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician's global assessment. Each subscore~is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst)."|Up to Week 4|The full analysis set (FAS) consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2735026|NCT00984542|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2735027|NCT00984542|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2735028|NCT00984542|Secondary|Best Response|"Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details):~complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On‐treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. 8 patients were not evaluable.|||participants|||Number
2735029|NCT00984542|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days|Total number of patients reported with any toxicity|||participants|||Number
2735030|NCT00984542|Primary|Time to Progression|Estimated probable duration from on-study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)|All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.|||days||95% Confidence Interval|Median
2735031|NCT00984490|Secondary|Changes in Circulating Insulin-like Growth Factor 1 (IGF-1) and IGF Binding Protein 3 (IGFBP-3)|Effect of study drug on circulating IGF-1 and IGFBP-3 as measured in ng/mL in peripheral blood samples taken pre-treatment and post-treatment with metformin|baseline and 23 days|No levels of IGF-1 and IGFBP-3 were determined. This clinical trial was closed due to slow accrual.|||units on a scale||Standard Deviation|Mean
2735032|NCT00984490|Primary|Change in Ki67 Levels Before and After Treatment|Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.|baseline and between 8-23 days|No Ki67 levels were determined. This clinical trial was closed due to slow accrual|||percentage of stained cell nuclei||Standard Deviation|Mean
2735033|NCT00984334|Primary|Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing.|Incidence and severity of treatment emergent adverse events on single dosing.|3 weeks|Intent to treat.|||participants|||Number
2735034|NCT00984308|Secondary|Sleep Apnea Treatment Rate||One year|Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.|||participants|||Number
2735035|NCT00984308|Primary|Hypertension Control|Medication-Adjusted Systolic Blood Pressure|One year|ITT|||mm Hg||Standard Deviation|Mean
2735036|NCT00984308|Primary|Sleep Apnea Diagnosis Rate|The number of patients with a diagnosis of sleep apnea|The entire study period (baseline and up to one-year)|The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.|||participants|||Number
2735037|NCT00984295|Primary|Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
2735038|NCT00984295|Primary|Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT|Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2735039|NCT00984295|Primary|Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2735040|NCT00984295|Primary|Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||units/mL||95% Confidence Interval|Geometric Mean
2735041|NCT00984295|Primary|Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||units/mL||95% Confidence Interval|Geometric Mean
2735042|NCT00984295|Primary|Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
2735043|NCT00984295|Primary|Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2735044|NCT00984295|Primary|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
2735045|NCT00984295|Primary|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT|Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||ELISA Ab units/mL||95% Confidence Interval|Geometric Mean
2735046|NCT00984295|Primary|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2735124|NCT00983853|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment||12 weeks after last dose of study drug|subjects who received at least 1 dose of study drug.|||participants|||Number
2755640|NCT00837616|Secondary|Rates of Lipid Oxidation After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||Kcal/Fat Free Mass/day||Standard Error|Mean
2735047|NCT00984295|Primary|Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL|Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2735048|NCT00984295|Primary|Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL|Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2735049|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer|Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2735050|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer|Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2735051|NCT00984295|Primary|Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL|Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2735052|NCT00984295|Primary|Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL|Antibody response to Diphtheria at 6 weeks postvaccination|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2735053|NCT00984295|Primary|Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL|Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline|6 weeks Postvaccination|"The per-protocol analysis set included participants~who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to~varicella at baseline, and followed protocol procedures."|||Participants|||Number
2735054|NCT00984295|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
2735055|NCT00984295|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
2735056|NCT00984295|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline|6 Weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
2735057|NCT00984282|Secondary|AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)|Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.|A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)|Pharmacokinetic (PK) analysis set=participants with PK data collected after 14 days of uninterrupted and unmodified dosing of sorafenib. If an interruption occurred within 14 days prior to the sample, no doses may be missed for 3 days prior to the sample, and no more than 3 doses could be missed 4 to 14 days prior to the sample collection date.|||mg*h/L||Standard Deviation|Geometric Mean
2735058|NCT00984282|Secondary|Maximum Percent Reduction in Target Lesion Size Based on Central Assessment|The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS|||Percentage of participants|||Number
2735059|NCT00984282|Secondary|Duration of Response (DOR) Based on Central Assessment|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS - responders only|||Days||Full Range|Median
2735125|NCT00983853|Secondary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12|number of subjects with undetectable HCV RNA|4 and 12 weeks after the first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug|||participants|||Number
2749529|NCT00880022|Primary|Arm Volume at End of Study|measured by tape and then volume was calculated.|end of scheduled treatments-day 30 of treatment|Study withdrawals were not included.|||ml||Inter-Quartile Range|Median
2735060|NCT00984282|Secondary|Response Rate Based on Central Assessment|Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS|||Percentage of participants||95% Confidence Interval|Number
2735061|NCT00984282|Secondary|Disease Control Rate (DCR) Based on Central Assessment|Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2735062|NCT00984282|Secondary|Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS|||Days||95% Confidence Interval|Median
2735063|NCT00984282|Secondary|Overall Survival (OS)|Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.|From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years|Full Analysis Set (FAS)|||Percentage of participants|||Number
2735064|NCT00984282|Primary|Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.|Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years|Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.|||Days||95% Confidence Interval|Median
2735065|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of Area Under the Curve|Plasma concentrations were used to determine the pharmacokinetic curves with determinations of area under the curve (AUC).The smallest AUC Day 0-6.5 associated with protection from detectable parasitemia, and the highest AUC Day 0-6.5 observed in any cases of malaria (prophylactic failures) were to be reported.|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Analysis was done on subjects who completed the study according to protocol|||ng*day/ml||Standard Deviation|Mean
2735066|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of T1/2.|Plasma concentrations (ng/ml) were used to determine the elimination half life (t1/2) of atovaquone (days).|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Population for analysis included According to Protocol Population.|||Days||Standard Deviation|Mean
2735067|NCT00984256|Primary|Prophylactic Efficacy of 3 Different Doses of Atovaquone/Proguanil (Malarone@) Given 1 Week Before Infectious Sporozoite Challenge Using the P. Falciparum Human Challenge Model.|Number of participants with prophylactic efficacy was determined by the absence of cases of malaria parasitemia, defined as microscopically detectable parasitemia by Giemsa-stained thick smears, in those receiving any dose of Malarone as compared to the control (no treatment) group|Days 6-20|"Analysis population was According to Protocol which included participants meeting all eligibility criteria, not meeting any elimination criteria, complying with defined protocol procedures and for whom data are available."|||participants with negative parasitemia|||Number
2735068|NCT00984204|Secondary|Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure||3 months||||participants|||Number
2735069|NCT00984204|Primary|Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.||30 mins||||participants|||Number
2735070|NCT00984204|Primary|Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.||7 days||||participants|||Number
2735071|NCT00984165|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 36 months.||||Participants|||Count of Participants
2749878|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
2735072|NCT00984165|Primary|Response to Graft Versus Host Disease (GVHD) Treatment|The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score >/= 70%). Non-responder (NR) <50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score </= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.|Up to 100 days|"No results were collected on the Donor Lymphocyte Infusion-Donor Arm. This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group."|||participants|||Number
2735073|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
2735074|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
2735075|NCT00984139|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)|The analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
2735076|NCT00984139|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
2735077|NCT00984139|Secondary|Number of Subjects With Solicited Local and General Symptoms|"Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.~Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius."|During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
2735078|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values|The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
2735079|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values|"The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.~Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure."|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
2735080|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
2735081|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
2735126|NCT00983853|Primary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 12||12 weeks after first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug|||participants|||Number
2735082|NCT00984126|Secondary|Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds.|Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent. The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion. 4. None: No improvement, or worsening of symptoms. This endpoint is measured during the preventive and on-demand sub-trial (during 90 months).|After 90 months|Full Aanalysis Set. The endpoint was measured for preventive and on-demand regimen for comparison of the efficacy of turoctocog alfa between regimens. Number of subjects analysed=subjects who received preventive and on-demand regimen and were evaluable for this outcome.|||Number of bleeds|||Number
2735083|NCT00984126|Secondary|Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen)|The number of bleeding episodes per year reported during the prevention period (during 90 months).|After 90 months|Full Analysis Set. Number of subjects analysed=Subjects who received preventive regimen and were evaluable for the outcome.|||Bleeding episodes/year||Full Range|Median
2735084|NCT00984126|Secondary|Frequency of Adverse Events and Serious Adverse Events|The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).|After 90 months|Safety Analysis Set includes all dosed subjects with data after dosing.|||Number of Events|||Number
2735085|NCT00984126|Primary|Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)|The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.|After 90 months|Full analysis set|||subjects|||Number
2735086|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration||||ng-hr/mL||Standard Deviation|Mean
2735087|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration||||ng-hr/mL||Standard Deviation|Mean
2735088|NCT00984061|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration||||ng/mL||Standard Deviation|Mean
2735089|NCT00984022|Secondary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.|Participants were assessed to see whether or not the surface area of the cellulitis was reduced by at least 30% and the number of such participants was reported.|2 weeks||||Participants|||Number
2735090|NCT00984022|Secondary|Change in Patient Rating of Pain|Change in mean pain score based on patient self-report, using Wong-Baker FACES pain rating scale. Scale ranges from 0 to 5, where 5 means the worst pain possible and 0 means no pain at all.|Baseline and 2 weeks||||Scores on a scale||Standard Deviation|Mean
2735091|NCT00984022|Primary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess|Participants were assessed to see whether or not the surface area of the abscess was reduced by at least 30%, and the number of such participants is reported.|2 weeks||||Participants|||Number
2735092|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735093|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735094|NCT00984009|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
2735095|NCT00983983|Primary|Tolerability|Number of participants who completed the study on their assigned study intervention.|5 months|The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).|||participants|||Number
2735096|NCT00983983|Primary|Serious Adverse Events|SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|5 months||||Number of Serious Adverse Events|||Number
2735097|NCT00983983|Primary|Safety Outcomes: Frequency of Adverse Events||5 months||||Total Number of Adverse Events|||Number
2735098|NCT00983983|Secondary|Biomarkers of Body Composition and Lipid Metabolism||5 months follow-up|||||||
2735127|NCT00983827|Primary|Safety|Number of procedure related adverse events that occurred during study.|16 weeks||||adverse events|||Number
2735100|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||hours||Full Range|Median
2735101|NCT00983957|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2735102|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters|The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).|Screening, Day 1, Day 67, Day 77|All participants who received at least one dose of study drug.|||participants|||Number
2735103|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs|Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.|Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge|All participants who received at least one dose of study drug.|||participants|||Number
2735104|NCT00983957|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*Pre-treatment (PreRx), Hemoglobin (low) as <0.85*PreRx, Aspartate Aminotransferase (AST) (high) as >1.25*PreRx if PreRx > upper limits of normal (ULN); >1.25*ULN if PreRx <=ULN; >1.25*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx <1; ≥2 if PreRx = Missing.|From start of treatment (Day 1) up to Day 78 or discharge|All participants who received at least one dose of study drug.|||participants|||Number
2735105|NCT00983957|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug|All participants who received at least one dose of study drug.|||participants|||Number
2735106|NCT00983957|Primary|Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2735107|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug|||hours||Full Range|Median
2735108|NCT00983957|Secondary|Time of Maximum Observed Plasma Concentration of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||hours||Full Range|Median
2735109|NCT00983957|Secondary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2735147|NCT00983580|Secondary|Characterization of ACF|A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. The number and total size of ACF sites may serve as risk markers for adenoma/carcinoma development. The median number of ACF sites per patient were collected prior to treatment.|Baseline|Of the 49 eligible patients receiving treatment in Arm I, 2 patients did not have ACF analysis done. The same number of patients of patients did not have ACF done in Arm II.|||number of ACF sites||Full Range|Median
2735110|NCT00983957|Primary|Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2735111|NCT00983957|Secondary|Maximum Observed Plasma Concentration of Norgestrel|Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography-mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2735112|NCT00983957|Primary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol|Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77|All participants who received the study drug.|||picogram per millilitre (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2735113|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735114|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735115|NCT00983931|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
2735116|NCT00983918|Primary|Pain Measured on Verbal Scale of 0-10|Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.|24 hours||||units on a scale||Standard Deviation|Mean
2735117|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the theophylline plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable theophylline plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration||||µg-hr/mL||Standard Deviation|Mean
2735118|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the theophylline plasma concentration versus time curve, from time 0 to the time of the last measurable theophylline concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration||||µg-hr/mL||Standard Deviation|Mean
2735119|NCT00983905|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that theophylline drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration||||µg/mL||Standard Deviation|Mean
2735120|NCT00983892|Primary|Summed Symptom Severity|Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.|3 months||||units on a scale||Standard Deviation|Mean
2735121|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)|Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data|||ratio (test/reference)||Full Range|Median
2735122|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)|Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data|||ratio (test/reference)||Full Range|Median
2735123|NCT00983853|Secondary|Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure||through 12 weeks after first dose of study drug|subjects with available plasma concentration data|||ratio (test/reference)||90% Confidence Interval|Least Squares Mean
2741870|NCT00939185|Secondary|Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital|Time of exam completion minus the start time of the examination.|Day 1|Safety population|||minutes||Full Range|Median
2735128|NCT00983801|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period.|||participants|||Number
2735129|NCT00983801|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period.|||participants|||Number
2735130|NCT00983801|Other Pre-specified|Number of Participants With Best Response as Assessed With Modified RECIST|Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).|||participants|||Number
2735131|NCT00983801|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks)|Participants who received at least 1 dose of study therapy.|||participants|||Number
2735132|NCT00983801|Secondary|Percentage of Participants With Disease Control Rate|Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).|||percentage of participants||95% Confidence Interval|Number
2735133|NCT00983801|Secondary|Progression Free Survival (PFS)|PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method).|From the date of initiation of study therapy to the date of progression (up to 8.1 months).|Participants who received at least 1 dose of ixabepilone. Participants who died without reporting prior progression were considered to have progressed on their death day. Participants who did not progress or die were censored on their last tumor assessment day. Participants without on-study tumor assessments were censored at start date of therapy.|||months||95% Confidence Interval|Median
2735134|NCT00983801|Secondary|Duration of Response|Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method.|From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)|Participants who received at least 1 dose of ixabepilone and had either CR or PR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
2741886|NCT00939107|Secondary|Quality of Life|Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)|twelve months posttreatment||2010-08-31|08/2010||||
2735135|NCT00983801|Secondary|Time to Response|Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure <10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment.|Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)|Participants who received at least 1 dose of study therapy and had a response of either CR or PR.|||weeks||Full Range|Median
2735136|NCT00983801|Primary|Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).|||percentage of participants||95% Confidence Interval|Number
2735137|NCT00983749|Primary|Safety (Including Endpoints Such an Increase NIHSS During or Immediately After ECP, and Acute Hemorrhage on Repeating Imaging, Serious Adverse Events Related to ECP, Mortality)|Safety was evaluated by the incidence of serious adverse events (SAEs) or acute neurological deterioration in relation to the study device and/or procedures at 30 days, the incidence of acute symptomatic hemorrhage on repeat imaging at 24 hours, the incidence of all adverse events (AEs) in the first 48 hours, and mortality at 30 days. The National Institutes of Health Stroke Scale (NIHSS) is a stroke severity scale, based on examination, that goes from 0 (no deficit) to a maximum of 42. Acute neurological deterioration - which was captured as a serious adverse event - was defined as a ≥4-point increase on the NIHSS, or a ≥2-point decline in level of consciousness item 1a on the NIHSS, or a new neurological deficit, or clinically significant worsening of motor function lasting more than 8 hours and attributable to a neurological entity. Symptomatic intracranial hemorrhage was defined as new hemorrhage on CT that was associated with acute neurological deterioration.|30 days||||participants|||Number
2735138|NCT00983749|Primary|Feasibility and Tolerability of External Counterpulsation|The first primary outcome measure was tolerability and feasibility. Tolerance was defined as the absence of any indications to stop the procedure or reduce the pressure to a non-therapeutic level. Feasibility was defined in the full-pressure group as the sustained (at least 30 minutes) tolerance of any pressure capable of causing a 15% augmentation of MFV in 90% of subjects, and defined in the sham-pressure group as the sustained tolerance of the sham pressure in all subjects.|During one hour of treatment||||participants|||Number
2735139|NCT00983645|Secondary|Lipid Levels||6 months post-transplant|Data cannot be located for analysis.||||||
2735140|NCT00983645|Secondary|Post-transplant Diabetes Mellitus||6 months post-transplant|Data cannot be located for analysis.||||||
2735141|NCT00983645|Secondary|Renal Function||6 months post-transplant|Data cannot be located for analysis.||||||
2735142|NCT00983645|Primary|Rejection||6 months post-transplant|Data cannot be located for analysis.||||||
2735143|NCT00983580|Other Pre-specified|Gene Expression Analysis|Differences in log-transformed values among ACF or patient characteristics will be compared using t tests or analysis of variance (ANOVAs).|Baseline and 12 months|Data were not collected for this endpoint.||||||
2735144|NCT00983580|Other Pre-specified|Effect of the Study Drugs and Placebo With Respect to Biomarkers|For continuous variables, we will use the 2-sample t-test (or nonparametric equivalent) to compare the active arm to the placebo arm. For categorical data, we will explore the relationship between the treatment arms and biomarkers with chi-square or fisher's exact tests. Correlations will be sought between caspase-3 staining, proliferative indices and their ratio, as well as other biomarkers using a chi-square test.|Baseline and 12 months|Data were not collected for this endpoint.||||||
2735145|NCT00983580|Secondary|Safety, Tolerability, and Adverse Events of Study Treatment|The National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 3.0 was used to grade all adverse events. The number of patients reporting a grade 3 or higher event are tabulated here. A grade 3 event is one categorized as being severe or medically significant but not immediately life-threatening. A grade 4 is considered life-threatening, and a grade 5 is death related to the event. A complete list of all adverse events is given in the Adverse Events section.|Up to 48 months from beginning treatment.|On Arm 1, 1 patient cancelled prior to treatment, 1 was a violation, 3 were deemed ineligible. On Arm 2, 3 were ineligible, 1 was a violation. All other patients were treated and evaluated for toxicity and included in this evaluation.|||Participants|||Count of Participants
2735146|NCT00983580|Secondary|Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms|The number of ACF sites per patient was collected at baseline and at 1-year time points. The percent change in ACF number was calculated as the number of ACF present at the 12-month post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites from baseline to year 1 post-treatment. A positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. The percent change in ACF number between arms was compared using a t-test.|At baseline and 12 months|All eligible treated patients that were assessed for ACF at baseline and after 1-year of treatment were included in this analysis.|||percentage of change in ACF number||Standard Deviation|Mean
2735368|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).|||participants|||Number
2735148|NCT00983580|Secondary|ACF Characteristics vs Adenoma Recurrence Rate|A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. At the 1-year time point, the presence of adenoma recurrence and the number of ACF sites was recorded for each patient. The percent change in ACF number was calculated as the number of ACF present at the 1-year post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites and a positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. A Wilcoxon Rank-sum test was used to assess the relationship between ACF percent change and adenoma recurrence rate. This analysis was only conducted in those participants who had at least 5 rectal ACF at baseline.|At baseline and 1 year|All patients that were eligible, treated, analyzed for ACF at baseline and 12-months, and had 5 or more ACF at baseline were included in this analysis.|||percentage of change in ACF number||Full Range|Median
2735149|NCT00983580|Primary|Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo|The primary endpoint is the proportion of participants with an adenoma recurrence at the 1-year follow-up colonoscopy exam. All eligible, randomized participants who have signed a consent form and received at least one follow-up endoscopy exam will be considered evaluable for the primary endpoint. This adenoma recurrence rate for DFMO + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. A 1-sided Chi-square test was used to determine if there was a significant difference between treatment arms.|At 1 year|On Arm 1, 1 patient cancelled prior to treatment, 1 was a violation, 3 were deemed ineligible, and 7 patients did not receive a follow-up endoscopy. On Arm 2, 3 patients cancelled prior to treatment, 1 was a violation, and 6 did not receive a follow-up endoscopy.|||proportion of participants|||Number
2735150|NCT00983541|Secondary|Evaluate Rate of Distant Mets Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
2735151|NCT00983541|Secondary|Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
2735152|NCT00983541|Secondary|Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months.|Trial did not meet accrual goals so analysis was not performed||||||
2735153|NCT00983541|Secondary|Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
2735154|NCT00983541|Secondary|Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy.||9 months|Trial did not meet accrual goals so analysis was not performed||||||
2735155|NCT00983541|Secondary|Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
2735156|NCT00983541|Primary|Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.||Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled.||||participants|||Number
2735157|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735158|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735159|NCT00983515|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
2735160|NCT00983489|Primary|Exclusive Breast Feeding Rate at Six Weeks Postnatal Age||6 weeks||||Participants|||Number
2735161|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|12 months|All randomized participants who received the intervention as randomized and who completed a 12 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||kg/meter square||Standard Deviation|Mean
2735162|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|9 months|All randomized participants who received the intervention as randomized and who completed a 9 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||kg/meter squared||Standard Deviation|Mean
2735163|NCT00983476|Secondary|Quality of Life: Sexual Life|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale.~The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
2735164|NCT00983476|Secondary|Quality of Life: Self-Esteem|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale.~The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and had data at 6 months were included in the analyses. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
2735165|NCT00983476|Secondary|Quality of Life: Physical Functioning|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale.~The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
2735166|NCT00983476|Primary|Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor.~The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
2735167|NCT00983476|Primary|Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor.~The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
2735168|NCT00983476|Primary|Body Mass Index (BMI) Within Obese Sample|BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30|6 months|Analyses excluded participants with BMI of 28-29.9 (overweight) at baseline, leaving only those with BMI >= 30 at baseline who received the intervention as randomized.|||kilogram/(meters squared)||Standard Error|Mean
2735169|NCT00983476|Primary|Body Mass Index (BMI)|BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1|6 months|All randomized participants who received any intervention as randomized were included in the primary analyses, regardless of the number of assessments completed. Receiving intervention as randomized was defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||kg/(meters squared)||Standard Error|Mean
2735170|NCT00983437|Secondary|Change From Baseline in the Medical Outcomes Study 6-Item Cognitive Functioning Scale (MOS-CF6) Total Score at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|"The MOS-CF 6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6-item responses include 6 choices, ranging from none of the time to all of the time. The CF-6 is scored by summing responses across the 6 items and converting the total to a 0- to 100-point scale, with higher scores indicating better cognitive functioning. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Months 3, 6, 9, and 12 (or last postbaseline observation)|Changes from baseline in MOS-CF6 total score were not summarized. This assessment was not performed in study C10953/3067/ES/MN (NCT00893789); therefore, the data obtained at screening for the current study would represent true baseline data only for new participants, of which there were none.||||||
2735171|NCT00983437|Primary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set with a Baseline value; n=number of participants with baseline and postbaseline value at given time point.|||units on a scale||Standard Deviation|Mean
2735186|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants|||Units on a scale||Standard Deviation|Mean
2735172|NCT00983437|Primary|"Number of Participants Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)"|The percentage of participants answering 'yes' to any of the 9 yes/no questions about suicidal behaviors, ideations, and acts at given time points are presented. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). Questions included the presence (yes) or absence (no) of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; n=number of participants with nonmissing value at given time point.|||participants|||Number
2735173|NCT00983437|Primary|Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT= head, eyes, ears, nose, throat. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint physical examination findings are summarized.|||participants|||Number
2735174|NCT00983437|Primary|Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint ECG findings are summarized.|||participants|||Number
2735175|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure ≥90 mm Hg plus increase of ≥10% from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; participants with a baseline and postbaseline value.|||participants|||Number
2735176|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results|Criteria for clinically significant abnormal urinalysis values: blood (hemoglobin) ≥2 unit increase from baseline; glucose ≥2 unit increase from baseline; ketones ≥2 unit increase from baseline; total protein ≥2 unit increase from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
2735177|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results|Criteria for clinically significant abnormal hematology values: hematocrit, men <0.37 L/L or women <0.32 L/L; hemoglobin, men ≤115 g/L or women ≤95 g/L; white blood cell (WBC) count ≤3x10^9/L or ≥20x10^9/L; eosinophils ≥10%; absolute neutrophil count (ANC) ≤1x10^9/L; platelet count ≤75x10^9/L or ≥700x10^9/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
2735178|NCT00983437|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk for work instability is low; 2 to 23, the risk is medium; and >23, the risk is high. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability). Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Months 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Full Analysis Set (those in the Safety Analysis Set with at least 1 post-baseline efficacy assessment) with a TBI-WIS score at baseline; n=number of participants with value at baseline and given time point.|||units on a scale||Standard Deviation|Mean
2735187|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants|||Units on a scale||Standard Deviation|Mean
2755641|NCT00837616|Secondary|Lipids Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||mg/dl||Standard Error|Mean
2735179|NCT00983437|Secondary|Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Improvement is defined as at least 1 point improvement from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.|||percentage of participants|||Number
2735180|NCT00983437|Secondary|Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.|||units on a scale||Standard Deviation|Mean
2735181|NCT00983437|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The participant's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.|||units on a scale||Standard Deviation|Mean
2735182|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements|Criteria for clinically significant abnormal vital signs values: pulse, ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure, ≥180 mm Hg and increase from baseline of ≥20 mm Hg or ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure, ≥105 mm Hg and increase from baseline of ≥15 mm Hg or ≤50 mm Hg and decrease from baseline of ≥15 mm Hg; temperature >38.3º celsius (C) and change from baseline of ≥1.1°C. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
2735183|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results|Criteria for clinically significant abnormal serum chemistry values: alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN); aspartate aminotransferase (AST) ≥3x ULN; alkaline phosphatase ≥3x ULN; gamma-glutamyl transpeptidase (GGT) ≥3x ULN; lactate dehydrogenase (LDH) ≥3x ULN; blood urea nitrogen (BUN) ≥10.71 mmol/L; creatinine ≥177 μmol/L; uric acid, men ≥625 μmol/L, women ≥506 μmol/L; bilirubin (total) ≥34.2 μmol/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set who had a baseline and at least one post-baseline value.|||participants|||Number
2735184|NCT00983437|Primary|Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study|Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category.|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
2735185|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship to study drug. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis, and seizure or suspected seizure were considered to be of potential clinical importance. DB=double-blind portion of the study (NCT00893789).|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set (study participants who received at least 1 dose of study drug)|||participants|||Number
2739124|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|6 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2735188|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants|||Units on a scale||Standard Deviation|Mean
2735189|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants|||Units on a scale||Standard Deviation|Mean
2735190|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants|||Units on a scale||Standard Deviation|Mean
2735191|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants|||Units on a scale||Standard Deviation|Mean
2735192|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 12|Intention to treat (ITT).|||participants|||Number
2735193|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 8|Intention to treat (ITT).|||participants|||Number
2735194|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 6|Intention to treat (ITT).|||participants|||Number
2735195|NCT00983385|Secondary|Participant's Satisfaction With Previous Analgesic Treatment at Baseline|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.|Baseline||||participants|||Number
2735196|NCT00983385|Secondary|Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.|Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.|Week 6|Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT).|||milligrams (mg)||Standard Deviation|Mean
2735197|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|"Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants.~Intention to Treat (ITT)."|||units on a scale||Standard Deviation|Mean
2735198|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear or positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
2735199|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Depression Score at Baseline|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
2735200|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
2755642|NCT00837616|Secondary|Changes in Insulin Growth Factor-I From Baseline at 12 Months||12 months||||ng/ml||Standard Error|Mean
2735201|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
2735202|NCT00983385|Secondary|Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
2735203|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Maintenance Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).|||participants|||Number
2735204|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT).|||participants|||Number
2735205|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants.|||Units on a scale||Standard Deviation|Mean
2735206|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants.|||units on a scale||Standard Deviation|Mean
2735207|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants.|||Units on a scale||Standard Deviation|Mean
2735208|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants.|||Units on a scale||Standard Deviation|Mean
2735209|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2735210|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2735211|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2755643|NCT00837616|Primary|Change in Weight From Baseline at 12 Months||12 months||||kilograms||Standard Error|Mean
2735212|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 6|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2735213|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|Baseline Visit|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2735214|NCT00983385|Secondary|painDETECT Assessment for Participants at End of the Maintenance Period|"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2735215|NCT00983385|Secondary|painDETECT Assessment for Participants at End of Titration and Optimal Dose Period|"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2735216|NCT00983385|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
2735217|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 weeks)||||Units on a scale||Standard Deviation|Mean
2735218|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2735219|NCT00983385|Secondary|Patient Global Impression of Change at End of the Maintenance Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).|||participants|||Number
2735220|NCT00983385|Secondary|Patient Global Impression of Change at End of Titration and Optimal Dose Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).|||participants|||Number
2735221|NCT00983385|Primary|The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|Baseline; End of Week 6 (6 Weeks)|Intention to treat. Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
2735222|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration||||pg-hr/mL||Standard Deviation|Mean
2735223|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration||||pg-hr/mL||Standard Deviation|Mean
2735224|NCT00983372|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration||||pg/mL||Standard Deviation|Mean
2735495|NCT00981084|Primary|Stroop|Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||number of colors named||Standard Deviation|Mean
2735225|NCT00983359|Secondary|Karnofsky Decay Time|Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.|From time of enrollment up to 5 years||||months||Full Range|Median
2735226|NCT00983359|Secondary|Time to Systemic Death|Descriptive analysis will be conducted using Kaplan-Meier survival analysis|From time of enrollment up to 5 years||||months||95% Confidence Interval|Median
2735227|NCT00983359|Secondary|Time to Neurological Death|Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death.|From time of enrollment up to 5 years||||months||Full Range|Median
2735228|NCT00983359|Secondary|Progression-free Survival (PFS)|Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.|Up to 5 years||||months||95% Confidence Interval|Median
2735229|NCT00983359|Primary|Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status|Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.|Up to 5 years||||patients|||Number
2735230|NCT00983346|Primary|Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.|The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.|Baseline and 6 weeks|Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study|||Percentage of Baseline Value|||Number
2735231|NCT00983307|Primary|Number of Participants That Experience Progression-free Survival.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||Participants|||Count of Participants
2735232|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735233|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735234|NCT00983294|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
2735235|NCT00983281|Primary|Mortality||Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.||||participants|||Number
2735236|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.||||pg-hr/mL||Standard Deviation|Mean
2735237|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.||||pg-hr/mL||Standard Deviation|Mean
2735238|NCT00983242|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.||||pg/mL||Standard Deviation|Mean
2735239|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735369|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).|||participants|||Number
2735240|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
2735241|NCT00983216|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
2735242|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||units on a scale||Standard Deviation|Mean
2735243|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||units on a scale||Standard Deviation|Mean
2735244|NCT00983073|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Number of participants with data available|||units on a scale||Standard Deviation|Mean
2735245|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||participants|||Number
2735246|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||participants|||Number
2735247|NCT00983073|Secondary|Participant's Satisfaction With Previous Analgesic Treatment|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Number of participants with data available.|||participants|||Number
2735248|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||Participants|||Number
2735249|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||Participants|||Number
2735250|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||Participants|||Number
2735251|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||Participants|||Number
2735252|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline, End of Week 12 (12 Weeks)|Number of participants with data available|||Units on a scale||Standard Deviation|Mean
2735253|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.|||Units on a scale||Standard Deviation|Mean
2741887|NCT00939107|Secondary|Number of Patients on Sick Leave|Measured by self-report of beeing on sick leave at the moment because of LBP|twelve months posttreatment|Number of patients on sick leave due to LBP pre-treatment.|||Participants|||Number
2735254|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||Units on a scale||Standard Deviation|Mean
2735255|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.|||Units on a scale||Standard Deviation|Mean
2735256|NCT00983073|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2735257|NCT00983073|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2735258|NCT00983073|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS)where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline||||units on a scale||Standard Deviation|Mean
2735259|NCT00983073|Primary|The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline to end of week 6|All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2735260|NCT00982995|Secondary|To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.||||||
2735261|NCT00982995|Primary|To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.||||||
2735262|NCT00982878|Secondary|Number of Participants With Adverse Events|To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy|15 days||||Participants|||Count of Participants
2735263|NCT00982878|Primary|CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)|"To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.~It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS).~Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist"|15 days||||ratio||Full Range|Mean
2735264|NCT00982865|Secondary|Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)|Number of subjects with clinical benefit (CR, PR, or SD) and PD according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Baseline until disease progression (assessed up to end of treatment [253 weeks])|"The SAF included all subjects who received at least 1 administration of MSC1936369B. Here Number of Subjects analysed = subjects evaluable for this endpoint."|||Subjects|||Number
2735265|NCT00982865|Secondary|Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)||Pre-dose on C1D1, C1D2, C1D5, C1D8; 2, 4, 8 h post-dose on C1D1; pre-dose, 2, 8, 24 h post-dose on C1D12-15; pre-dose, 2, 4 h post-dose on C1D3|Analysis population included subjects from safety analysis set having at least one pERK/tot ERK sample and not excluded from the analysis as per SAP. Number analyzed= subjects who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||fold change||Standard Deviation|Mean
2735266|NCT00982865|Secondary|Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Twice Daily|AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||Percentage of AUC 0-∞||Geometric Coefficient of Variation|Geometric Mean
2735267|NCT00982865|Secondary|Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Once Daily|AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||percentage of AUC 0-∞||Geometric Coefficient of Variation|Geometric Mean
2735268|NCT00982865|Secondary|Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (With Food Effect)|AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here, “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.|||Percentage of AUC 0-∞||Geometric Coefficient of Variation|Geometric Mean
2735269|NCT00982865|Secondary|Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (Without Food Effect)|AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Percentage of AUC 0-∞||Geometric Coefficient of Variation|Geometric Mean
2735270|NCT00982865|Secondary|Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 1|AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Percentage of AUC 0-∞||Geometric Coefficient of Variation|Geometric Mean
2735271|NCT00982865|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Twice Daily|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2735272|NCT00982865|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Once Daily|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2735273|NCT00982865|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (With Food Effect)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here, “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2735274|NCT00982865|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (Without Food Effect)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was >20% of AUC0-inf, Vz/F derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2735275|NCT00982865|Secondary|Apparent Volume of Distribution Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was >20% of AUC0-inf, Vz/F derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2735276|NCT00982865|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Twice Daily|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number analyzed” signifies those who were evaluated at the specified time point.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2735277|NCT00982865|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Once Daily|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2735278|NCT00982865|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (With Food Effect)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2735279|NCT00982865|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (Without Food Effect)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf. As AUCextra was >20% of AUC0-inf, CL/f derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2735280|NCT00982865|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf. As AUCextra was >20% of AUC0-inf, CL/f derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2735281|NCT00982865|Secondary|Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Twice Daily|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2735282|NCT00982865|Secondary|Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Once Daily|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2735283|NCT00982865|Secondary|Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (With Food Effect)|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2735325|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 126 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2735284|NCT00982865|Secondary|Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 2 (Without Food Effect)|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was >20% of AUC0-inf, t1/2 derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
2735285|NCT00982865|Secondary|Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 1|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was >20% of AUC0-inf, t1/2 derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
2735286|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Once Daily|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735287|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Twice Daily|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735288|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (With Food Effect)|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735289|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (Without Food Effect)|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735290|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B : Regimen 1|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735291|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Twice Daily|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735292|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Once Daily|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number analyzed” signifies those who were evaluated at the specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735293|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 2 (With Food Effect)|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735294|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: : Regimen 2 (Without Food Effect)|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number Analyzed=0 because there was no subject analyzed at specified time point.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735295|NCT00982865|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2735296|NCT00982865|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Twice Daily|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||Hours (h)||Full Range|Median
2735297|NCT00982865|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Once Daily|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies those who were evaluated at the specified time point.|||Hours (h)||Full Range|Median
2735298|NCT00982865|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (With Food Effect)|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set (FES). Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Hours (h)||Full Range|Median
2735299|NCT00982865|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (Without Food Effect)|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.|||Hours (h)||Full Range|Median
2735300|NCT00982865|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.|||Hours (h)||Full Range|Median
2735301|NCT00982865|Secondary|Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily|Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1|PKS analysis set. Here “Number analyzed” signifies those who were evaluated at the specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735302|NCT00982865|Secondary|Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily|Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number Analyzed” signifies the subjects who were evaluated at that specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735303|NCT00982865|Secondary|Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect)|Cmax was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2|The food effect analysis set included all subjects who fulfilled following conditions: Food & drink intake, trial medication administration according to protocol, & not excreted irregularly, PK samples collected. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this endpoint.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735304|NCT00982865|Secondary|Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect)|Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1|PKS analysis set. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure and “Number analyzed” signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735305|NCT00982865|Secondary|Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1|Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours (h) post-dose on Cycle 1(C1) Day 1 (D1), Cycle 1 Day 12 (D12) and Cycle 3 (C3) Day 1|PK analysis set: subjects received at least 1 dose of drug & provided sufficient PK serum samples for at least 1st 24h following 1st dose of C1D1. Number of Participants Analyzed=subjects evaluable for this endpoint & Number analyzed=subjects evaluated at specified time point & “0”indicates no subject analyzed for that specific time point.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2735306|NCT00982865|Secondary|Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events|Any clinically significant changes in laboratory evaluations and vital signs were recorded as treatment emergent adverse events. The clinical laboratory parameters that were assessed included: Hematological parameters, Blood chemistry parameters, Urinalysis and the vital signs that were assessed included: Blood pressure, Heart rate, Temperature and Weight. SAF analysis was used.|Baseline up to 253 weeks|SAF analysis was used.|||Subjects|||Number
2735307|NCT00982865|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Death||Baseline up to 253 weeks|ALL subject analysis set was used which included all the subjects who signed the informed consent form and entered the study.|||Subjects|||Number
2735308|NCT00982865|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 253 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 253 weeks|Safety Analysis Set (SAF) included all subjects who received at least 1 dose of MSC1936369B treatment.|||Subjects|||Number
2735309|NCT00982865|Primary|Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21|DLT was defined as any of following toxicities at any dose level according to using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) v3.0(CTCAE), probably or possibly related to trial medication by investigator or sponsor: a)Any Grade 3 or more non-haematological toxicity excluding: (i)Grade 3 asymptomatic increase in liver function tests (Aspartate Aminotransferase, Alanine transaminase, Alkaline Phosphatase reversible within 7 days for subjects without liver involvement, or grade 4 for subjects with liver involvement; (ii)Grade 3 vomiting if it is encountered despite adequate and optimal therapy (e.g. serotonin [5HT3] antagonists and corticosteroids); (iii)Grade 3 diarrhoea if it is encountered despite adequate and optimal anti diarrhoea therapy; b)Grade 4 neutropenia of >5 days duration or febrile neutropenia lasting for more than 1 day; c)Grade 4 thrombocytopenia >1 day or grade 3 with bleeding; d)Any treatment delay >2 weeks due to drug-related AEs.|Day 1 up to Day 21 of Cycle 1|"Dose Escalation Analysis Set included all subjects who meet at least 1 of following criteria:~subjects who experienced any DLT during Cycle 1 & who received planned treatment."|||Subjects|||Number
2735310|NCT00982735|Secondary|Change From Baseline in Microalbuminuria at 24 Weeks||Baseline and 24 weeks||||Participants|||Number
2735311|NCT00982735|Secondary|Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion|A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).|24 weeks||||Participants|||Number
2735312|NCT00982735|Primary|Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.||24 weeks||||Participants|||Number
2735313|NCT00982657|Secondary|Number of Participants With Anti- CVX-060 Antibodies||Baseline up to 28 days after last CVX-060 dose|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, no Anti-CVX-060 antibody assessment was conducted.||||||
2735314|NCT00982657|Secondary|Duration of Response|Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.|Baseline up to 7 days post last dose of study medication|Duration of response was not calculated as there were no participants with objective response.||||||
2735326|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2735315|NCT00982657|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|Baseline up to 7 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2735316|NCT00982657|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.|||Participants|||Number
2735317|NCT00982657|Secondary|Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels||Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, pharmacodynamics assessment was not conducted.||||||
2735318|NCT00982657|Secondary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
2735319|NCT00982657|Secondary|Pharmacokinetic Parameters of CVX-060|Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.|Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study,pharmacokinetics assessment was not conducted.||||||
2735320|NCT00982657|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.|Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study.The PFS endpoint was a pre-specified endpoint for the Phase II portion of the study, and was therefore not assessed.||||||
2735321|NCT00982657|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.|Baseline up to Cycle 1( Day 1 to Day 42)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study, no MTD was assessed.||||||
2735322|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days of follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Events/100 years of patient exposure|||Number
2735323|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735324|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104|Mean of 9-point SMPG at 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 140 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2735327|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2735328|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2735329|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735330|NCT00982644|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2735331|NCT00982592|Secondary|Incidence of Toxicities (grades1 and 2)|Defined as percentage of patients who experienced a toxicity with grade 1 or 2 (worst grade) related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|Up to 4 years|All the patients who started the treatment.|||percentage of patients|||Number
2735332|NCT00982592|Secondary|Incidence of Toxicities (Grade 3 and Higher)|Defined as percentage of patients who experienced a toxicity with grade 3 or higher related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0|Up to 4 years|All the patients who started the treatment.|||percentage of patients|||Number
2735333|NCT00982592|Secondary|Overall Survival|Defined as time from randomization day until death from any cause.|up to 4 years|Intent-to-treat population|||months||95% Confidence Interval|Median
2735334|NCT00982592|Secondary|Objective Response Rate|Defined as the percentage of the patients who had complete response (CR) or partial response (PR) per RECIST 1.1.|Up to 4 years|Intent-to-treat population|||percentage of patients|||Number
2735335|NCT00982592|Primary|Median Progression-free Survival (PFS)|PFS is defined as the time from randomization until objective tumor progression or death from any cause and is evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|up to 4 years|Intent-to-treat population|||months||95% Confidence Interval|Median
2735336|NCT00982553|Primary|Raltegravir Minimum Plasma Concentrations|Raltegravir minimum plasma concentrations by pharmacokinetic analyses|Day 20||||ng/mL||95% Confidence Interval|Geometric Mean
2735337|NCT00982553|Primary|Ribavirin Minimum Plasma Concentration|Ribavirin minimum plasma concentration by pharmacokinetic analyses|Day 20||||ng/mL||95% Confidence Interval|Geometric Mean
2735338|NCT00982553|Primary|Raltegravir Maximum Plasma Concentration||Day 20||||ng/mL||95% Confidence Interval|Geometric Mean
2735339|NCT00982553|Primary|Ribavirin Maximum Plasma Concentration|Pharmacokinetic analyses of blood samples|Day 20|Per protocol|||ng/mL||95% Confidence Interval|Geometric Mean
2735340|NCT00982488|Primary|Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment through a maximum of 82 months + 30 days|All participants who received at least 1 dose of study drug|||Participants|||Number
2735341|NCT00982423|Secondary|Plasma Cyclic Guanosine Monophosphate (cGMP) at Baseline and in Response to Decreasing Furosemide Dose|Any change in atrial filling pressures leads to the release of atrial natriuretic peptides (ANP) from the heart. Once released, atrial peptides exert potent direct vasodilator and natriuretic actions by virtue of the ability to increase their intracellular second messenger, cGMP. Plasma cGMP correlates closely with the severity of congestive heart failure.|3 weeks, approximately 6 weeks||||pg/mL||Standard Deviation|Mean
2735342|NCT00982423|Secondary|Angiotensin II at Baseline and in Response to Decreasing Furosemide Dose|Renin activates the renin-angiotensin system by cleaving angiotensinogen, produced by the liver, to yield angiotensin I, which is further converted into angiotensin II by the angiotensin-converting enzyme (ACE) primarily within the capillaries of the lungs. Angiotensin II then constricts blood vessels, increases the secretion of antidiuretic hormone (ADH) and aldosterone, and stimulates the hypothalamus to activate the thirst reflex, each leading to an increase in blood pressure.|3 weeks, approximately 6 weeks||||pg/mL||Standard Deviation|Mean
2742118|NCT00937937|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years||||months||95% Confidence Interval|Median
2735343|NCT00982423|Secondary|Plasma Renin Activity at Baseline and in Response to Decreasing Furosemide Dose|Plasma renin activity is a measure of the activity of the plasma enzyme renin, which plays a major role in the body's regulation of blood pressure, thirst, and urine output. Renin is an enzyme that hydrolyses angiotensinogen secreted from the liver into the peptide angiotensin I. Renin's primary function is to cause an increase in blood pressure, leading to restoration of perfusion pressure in the kidneys.|3 weeks, approximately 6 weeks||||ng/mL/hr||Standard Deviation|Mean
2735344|NCT00982423|Secondary|Aldosterone at Baseline and in Response to Decreasing Furosemide Dose|Aldosterone is part of the renin-angiotensin-aldosterone system (RAAS). Drugs that interfere with the secretion or action of aldosterone are in use as antihypertensives, like lisinopril, which lowers blood pressure by blocking the angiotensin-converting enzyme (ACE), leading to lower aldosterone secretion. The net effect of these drugs is to reduce sodium and water retention but increase retention of potassium.|3 weeks, approximately 6 weeks||||ng/dL||Standard Deviation|Mean
2735345|NCT00982423|Secondary|Renal Plasma Flow at Baseline and in Response to Decreasing Furosemide Dose|Effective renal plasma flow (eRPF) is a measure used to calculate renal plasma flow (RPF) and hence estimate renal function. Renal plasma flow is the volume of blood plasma that flows through the kidneys per unit time, measured as ml/min.|3 weeks, approximately 6 weeks||||ml/min||Standard Deviation|Mean
2735346|NCT00982423|Primary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at Baseline and in Response to Decreasing Furosemide Dose|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|3 weeks, approximately 6 weeks||||ml/min||Standard Deviation|Mean
2735347|NCT00982410|Secondary|As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. The outcome measure below represents the average WHY MPI General Activity score in each Arm/Group, across the entire follow-up period, adjusted for baseline WHY MPI General Activity score, but restricted here to study participants that partook in at least one treatment group session.|Baseline, 3mo, 6mo, 12mo follow-up||||units on a scale||Standard Error|Mean
2735348|NCT00982410|Secondary|As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|Per study protocol, participants were asked to attend 10 sessions, which comprised the intervention for CBT participants and educational support for EUC participants. Some participants in each group did not attend any sessions, yet participated in follow-up assessments. The As-treated analysis was undertaken to evaluate the impact of the intervention, among participants that attended at least 1 session. As in the Primary Analysis, average pain last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation|Baseline, 3-, 6-, 12-months||||units on a scale||Standard Error|Mean
2735349|NCT00982410|Secondary|Self-efficacy of Physical Functioning|The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS subscale, self-efficacy for physical function (FSE), utilized to assess management of pain-related disability, with respect to several aspects of daily functioning. This scale have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS FSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of CPSS FSE.|Baseline, 3-, 6-, 12- months||||units on a scale||Standard Error|Mean
2735350|NCT00982410|Secondary|Self-efficacy of Pain Management|As measured via CPSS PSE score at each time point. The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS PSE subscale is a measure of self-efficacy for pain management. These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS PSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline CPSS PSE.|Baseline, 3-, 6-, 12- months||||units on a scale||Standard Error|Mean
2735351|NCT00982410|Primary|Pain Tolerance|Pain tolerance was measured by the amount of time the participant could hold their hand immersed in a vessel of cold water in seconds. The maximum allowed duration of the test was two minutes. The outcome measure below represents the average duration of task in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of pain tolerance.|Baseline, 3-,6-,12-months||||seconds||Standard Error|Mean
2735352|NCT00982410|Primary|Drug Use|# days used illicit drugs in the past 30 days, as assessed via timeline follow-back (TLFB) calendars. Use of illicit drugs and misuse of prescription drugs (e.g., Rx opioids) were recorded for the 30 days prior to the follow-up visit. #days in a controlled environment (e.g., hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days drug use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used illicit drugs.|Baseline, 3-, 6-, 12- months||||#Days used||Standard Error|Mean
2735353|NCT00982410|Primary|Alcohol Use|#days used alcohol in the past 30 days, as assessed via timeline follow-back(TLFB) calendars. #days in a controlled environment (e.g. hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days alcohol use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used alcohol.|Baseline, 3-, 6-, 12- months||||#Days used||Standard Error|Mean
2735367|NCT00982280|Secondary|Participant's Satisfaction With Previous Analgesic Treatment.|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Intention to treat (ITT).|||participants|||Number
2742119|NCT00937833|Primary|Number of Continent Patients Post Prostatectomy||1 Month||||participants|||Number
2735354|NCT00982410|Primary|The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. Aspects include ability to perform chores inside the home, activities away from the home, and social functioning. The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period, and was adjusted for baseline WHY MPI General Activity score.|Baseline, 3-,6-, 12-month||||units on a scale||Standard Error|Mean
2735355|NCT00982410|Primary|Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period. Average pain in the last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation.|Baseline, 3-, 6-, & 12-months||||units on a scale||Standard Error|Mean
2735356|NCT00982397|Secondary|Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free||Implant to one year post-implant|Includes randomized secondary prevention patients from Phase II.|||percentage of patients|||Number
2735357|NCT00982397|Primary|Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off|In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.|At implant|Of the 236 subjects implanted, 40 subjects / episodes were classified as not useable. In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.|||percentage of patients||97.5% Confidence Interval|Number
2735358|NCT00982397|Primary|Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I)|In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.|Implant to one month post-implant|Phase I subjects (a subset of the total number of subjects) implanted with a Protecta device with at least 30 days of follow-up or a USADE within the first 30 days post-implant are included in this analysis. One hundred subjects met the criteria above and are included in the analysis.|||percentage of patients||95% Confidence Interval|Number
2735359|NCT00982397|Primary|Percentage of Subjects Who Are Inappropriate Shock Free|Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .|Implant to one year post-implant||||percentage of patients||95% Confidence Interval|Number
2735360|NCT00982345|Primary|17-item Hamilton Depression Rating Scale (HDRS)|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|Started: March 2009 Ending March 2011||||units on a scale||Standard Deviation|Mean
2735361|NCT00982319|Secondary|Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor|"Phase II protein expression of cytoprotective enzymes known to be modulated by sulforaphane in DCIS specimens.~Cytoprotective enzymes measured (NQ01 and AKR1C1 expression) based on immunohistochemical analysis. Expression was categorized by the study pathologist based on percentage of cells expressing antibody on the slide."|Change from baseline to 14 days post-intervention||||% change of expression in tumor cells||Standard Deviation|Mean
2735362|NCT00982319|Primary|Absolute Change in Mean Proliferative Rate Measured by Ki67%|Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.|Change from baseline to 14 days post-intervention|All participants who completed the 14-day intervention on either study arm were included in analysis.|||percentage of Ki67||Standard Deviation|Mean
2735363|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 6 participants with previous oxycodone treatment.|||Ratio|||Number
2735364|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Transdermal Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Transdermal Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 48 participants with previous transdermal buprenorphine treatment.|||Ratio|||Number
2735365|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 12 weeks|Intention to treat (ITT).|||participants|||Number
2735366|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 6 weeks|Intention to treat (ITT).|||participants|||Number
2735370|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).|||participants|||Number
2735371|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).|||participants|||Number
2735372|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|12 Weeks|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2735373|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|6 Weeks|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2735374|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|12 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Median
2735375|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|6 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Median
2735376|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|12 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Mean
2735377|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|6 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Mean
2735378|NCT00982280|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Mean
2735379|NCT00982280|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 12 (12 weeks)|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2735380|NCT00982280|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 6 (6 weeks)|Intention to treat|||Units on a scale||Standard Deviation|Mean
2735381|NCT00982280|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat|||units on a scale||Standard Deviation|Mean
2735382|NCT00982280|Primary|Responder Rate|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period after 6 weeks of tapentadol PR treatment as with their previous analgesic treatment.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).|||Participants|||Number
2735383|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 7 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2735384|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735385|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735386|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment|Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Treatment week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 12 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2735387|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2735388|NCT00982228|Primary|Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin|The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.|Week 0, Week 106|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||%B/T||Standard Deviation|Mean
2735389|NCT00982228|Secondary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2735390|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2735391|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Events/100 years of patient exposure|||Number
2735392|NCT00982228|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using LOCF (last observation carried forward).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2735393|NCT00982189|Secondary|Changes TNFa (Tumor Necrosis Factor Alpha)|This biomarker represents systemic inflammation within in the body.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||pg/mL||Standard Error|Geometric Mean
2735394|NCT00982189|Secondary|Changes IL-6 (Interleukin-6)|This biomarker represents systemic inflammation within in the body.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||pg/mL||Standard Error|Geometric Mean
2735395|NCT00982189|Secondary|Changes hsCRP (C-reactive Protein)|This biomarker represents systemic inflammation within in the body.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||mcg/mL||Standard Error|Geometric Mean
2735396|NCT00982189|Secondary|Changes in Small Artery Elasticity|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||mL/mmHgx100||Standard Error|Mean
2735397|NCT00982189|Secondary|Changes in Blood Lipids|Blood lipids include routine cholesterol measurements that are monitored in clinical practice. They are measured in blood after a blood draw is performed. The specific measurements include: a) total cholesterol, b) low-density lipoprotein cholesterol, c) high-density lipoprotein cholesterol, and d) triglycerides|change from baseline to 4 months|n = 18 Pravastatin vs. n = 16 P-placebo The outcome is analyzed as the 'main effect' for pravastatin versus placebo, as standard for factorial study designs. Since pravastatin, but not lisinopril, influences cholesterol, the analysis defines Pravastatin and P-placebo groups by pooling across lisinopril groups (i.e., L-placebo + Lisinopril group).|||(mg/dL)||95% Confidence Interval|Mean
2735398|NCT00982189|Secondary|Changes in Blood Pressure|Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)|change from baseline to 4 months|n=17 Lisinopril vs. n=17 L-placebo The outcome is analyzed as the 'main effect' for lisinopril versus placebo, as standard for factorial study designs. Since lisinopril, but not pravastatin, influences blood pressure, the analysis defines Lisinopril and L-placebo groups by pooling across pravastatin groups (i.e., P-placebo + Pravastatin groups).|||(mmHG)||95% Confidence Interval|Mean
2735399|NCT00982189|Primary|Change From Baseline to Month 4 in the Framingham Risk Score (FRS)|The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)|Change from baseline to 4 months|All participants had Framingham risk score (FRS) estimated at baseline and month 4. The change from baseline to month 4 was calculated as the outcome.|||Percent probability of CHD event in 10yr||Inter-Quartile Range|Median
2735400|NCT00982189|Primary|Number of Participants Who Took >90% of Their Doses (by Pill Count)|The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'|4 months|Number of participants who took >90% of their doses (by pill count)were studied. All participants who returned unused medications at end of the study were included for these analyses|||participants|||Number
2735401|NCT00982189|Primary|Number of Participants Who Stated (by Self-report) That They Had Side Effects|Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.|4 months|Number of participants who stated (by self-report) that they had side effects|||participants|||Number
2735402|NCT00982137|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.~All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups."|Day 0 up to Day 60 post-vaccination|Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).|||Participants|||Number
2735403|NCT00982137|Primary|Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination|Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.|Day 0 (Pre-vaccination) through Day 30 post-vaccination|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).|||Participants|||Number
2735496|NCT00981084|Primary|CPT -Test of Information Processing Speed|"Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores.~Continuous Performance Test (CPT) - Vigilance and reaction time."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||milliseconds||Standard Deviation|Mean
2735404|NCT00982137|Secondary|Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.~Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2735405|NCT00982137|Secondary|Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.~Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)"|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2735406|NCT00982137|Primary|Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.|"Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.~The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).|||Participants|||Number
2735407|NCT00982137|Primary|Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.~The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).|||Participants|||Number
2735408|NCT00982111|Secondary|Percentage of Participants With EGFR Measured by IHC|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment|||percentage of participants|||Number
2735409|NCT00982111|Secondary|Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.|||H-Score||Standard Deviation|Mean
2735410|NCT00982111|Secondary|Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle =3 Weeks)|All randomized participants who had evaluable baseline and postbaseline LCSS data.|||millimeter (mm)||Standard Deviation|Mean
2735453|NCT00981409|Secondary|The Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|FPX or UFH treatment period (Days 5-10, on average)|Safety population: all participants who received at least one dose of medication (FPX or UFH).|||percentage of participants|||Number
2735411|NCT00982111|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.|||units on a scale||Standard Deviation|Mean
2735412|NCT00982111|Secondary|Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline to Study Completion (Up to 31.6 Months)|All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.|||participants|||Number
2735413|NCT00982111|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks|Participants who were randomized to necitumumab and had evaluable PK data.|||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
2735414|NCT00982111|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.|Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13|||Months||95% Confidence Interval|Median
2735415|NCT00982111|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 30.4 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2735416|NCT00982111|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79|||Months||95% Confidence Interval|Median
2735417|NCT00982111|Primary|Overall Survival Time (OS)|OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31.6 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72|||Months||95% Confidence Interval|Median
2735418|NCT00982033|Primary|Exercise Treadmill Time|"Treadmill exercise time to exhaustion on the modified naughton protocol.~LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model."|Baseline, 24 week visit||||seconds||Standard Deviation|Mean
2735419|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline, 52 weeks|All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
2735420|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants|The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.|Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
2735421|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug.|||centimeters (cm)||Standard Error|Least Squares Mean
2735422|NCT00982020|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants|The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).|52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
2735423|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).|Baseline, 52 weeks|All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
2735424|NCT00982020|Secondary|Time to Event for 7%, 15%, and 25% Weight Gain for All Participants|Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).|Baseline up to 52 weeks|"65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued.~122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.~161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued."|||days||95% Confidence Interval|Median
2735425|NCT00982020|Secondary|Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology.|||kg/m^2||Standard Error|Least Squares Mean
2735426|NCT00982020|Primary|Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
2735427|NCT00982007|Primary|Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.||Day 35|Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment|||g/dL||Standard Deviation|Mean
2735428|NCT00981825|Primary|CFU (Colony Forming Units)|Total number of salivary bacterial colony forming units (lower number = less colonies present)|4 hours||||number of colony forming units||Standard Deviation|Mean
2735429|NCT00981812|Primary|Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.||At time of biopsy||||Breast Lesions|||Number
2735430|NCT00981747|Secondary|Change in Shortness of Breath (SOB) Score|Change in symptoms of SOB as determined by St. Georges Respiratory Questionnaire score. This score ranges from 0 to 100 with a higher score indicating more problems breathing.|At baseline and three months post each intervention.||||score on a scale||Standard Deviation|Mean
2735431|NCT00981747|Secondary|Change in Forced Vital Capacity (FVC)|Change in FVC before and after treatment compared to placebo. FVC is a measure of lung size.|At baseline and three months post each intervention.||||liters||Standard Deviation|Mean
2735432|NCT00981747|Primary|Change in Six Minute Walk Distance in Meters|Change in 6MWD before and after treatment compared to placebo|At baseline and three months post each intervention.||||meters||Standard Deviation|Mean
2735433|NCT00981669|Primary|Number of Participants With Adverse Events.|Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.|Within the first five days post-vaccination.||||participants|||Number
2735434|NCT00981669|Secondary|Anti-rotavirus IgA Level.|It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.|before each dose (total of doses:3) and after 6 weeks of the third dose|As in most phase I trials, sample size was not calculated to provide statistically significant differences between groups. Rather, a descriptive analysis on the frequency of AE and immunogenicity data was undertaken.|||Arbitrary units||Inter-Quartile Range|Median
2735435|NCT00981630|Secondary|Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer < 1:10.|Day 30 up to 12 months post-vaccination|Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).|||Participants|||Number
2735436|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.|Day 30 post-vaccination|Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2735437|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.|Day 11 and Day 30 post-vaccination|Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2735468|NCT00981253|Secondary|Heart Rate Variability During Controlled Breathing (HRV-DB)|Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during a 100-second controlled breathing task.|At 12 weeks||||ms||95% Confidence Interval|Least Squares Mean
2735438|NCT00981630|Primary|Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.|Day 0 (post-vaccination) up to Day 30 post-vaccination|Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).|||Participants|||Number
2735439|NCT00981630|Primary|Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.|||Participants|||Number
2735440|NCT00981630|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 11 and Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.|||Participants|||Number
2735441|NCT00981578|Secondary|Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months|Quality of life was evaluated using average change from baseline at 3 Months using the Pain Interference section of the Brief Pain Inventory (BPI-Pain Interference). Larger change from Baseline numbers indicate improved function. Pain Interference is the mean of seven questions scored on an 11-point scale of 0 (does not interfere) to 10 (completely interferes). A positive change from Baseline (higher values) at the 3 Month visit indicates improvement or a reduction in pain interference|Baseline, 3 months||||Score on a Scale||Standard Deviation|Mean
2735442|NCT00981578|Secondary|Change in NRS Pain Scores From Baseline at 3 Months|Efficacy was evaluated by change in Numerical Rating Scale (NRS) pain scores at 3 months post treatment The NRS is an 11 point scale (0-10) with 0 as no pain and 10 as the worst pain. Larger numbers in score change from baseline indicate improvement (decrease) in pain. Two points improvement has been reported as a clinically meaningful.|Baseline, 3 months||||Score on a scale||Standard Deviation|Mean
2735443|NCT00981578|Primary|Number of Adverse Device Effects|Adverse effects outcomes are reported in the adverse events module.|3 months||||Events|||Number
2735444|NCT00981526|Secondary|Body Composition: Percent Total Body Fat|Body composition estimated by percent total body fat as measured by a dual energy absorptiometry (DXA) scan in both experimental and placebo arms at 12 weeks.|12 weeks||||percentage of body fat||Standard Deviation|Mean
2735445|NCT00981526|Secondary|Body Composition: Waist to Hip Ratio|Body composition as estimated by waist to hip ratio in both experimental and placebo arms at 12 weeks.|12 weeks||||Ratio||Standard Deviation|Mean
2735446|NCT00981526|Secondary|Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores.|The Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS) were used to assess the positive and negative symptoms in experimental and placebo arms at 12 weeks. The PANSS total scale includes positive and negative subscales. For both subscales, the score ranges from 7-49 and total PANSS score ranges from 30-210. The total scale is a summation of all the subscales. The SANS score ranges from 0-100. For all scales, a greater score represents a worse outcome.|12 weeks||||units on a scale||Standard Deviation|Mean
2735447|NCT00981526|Secondary|Lipid Metabolism - LDL-cholesterol and HDL-cholesterol|Lipid metabolism - fasting low density lipoprotein (LDL) and high density lipoprotein (HDL) are estimated in both experimental and placebo arms at 12 weeks.|12 weeks||||mg/dl||Standard Deviation|Mean
2735448|NCT00981526|Primary|Triglycerides|Fasting triglycerides assessed in both experimental and placebo arm at week 12.|12 weeks||||mg/dl||Standard Deviation|Mean
2735449|NCT00981526|Primary|Insulin Resistance|Insulin resistance as estimated by homeostasis model of assessment of insulin resistance (HOMA-IR) at week 12 in both the experimental and placebo arm. Insulin resistance is a condition in which cells fail to respond to the normal action of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.|12 weeks||||HOMA-IR scores||Standard Deviation|Mean
2735450|NCT00981461|Primary|Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks||||hairs per cm^2||Standard Deviation|Mean
2735451|NCT00981435|Secondary|Intraocular Inflammation|The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.|Up to week 12|Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).|||Participants|||Count of Participants
2735452|NCT00981435|Primary|Intraocular Pressure (IOP) Change|IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.|Baseline to Week 12|Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available at 6 weeks, 25 at 12 weeks); Non-steroidal anti-inflammatory (28 enrolled, 27 available at 6 and 12 weeks); Steroid (37 enrolled, 33 available at 6 weeks, 29 at 12 weeks).|||mmHg||Standard Deviation|Mean
2735454|NCT00981409|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10|The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||points on a scale||Standard Deviation|Mean
2735455|NCT00981409|Secondary|The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse|"Improved, No change, or Worse was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE."|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||percentage of participants|||Number
2735456|NCT00981409|Secondary|The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||percentage of participants|||Number
2735457|NCT00981409|Primary|The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||percentage of participants|||Number
2735458|NCT00981370|Primary|To Determine if Red Cell Survival as Assessed by Hemoglobin Level, Reticulocyte Count, Lactic Acid Dehydrogenase, and Plasma Hemoglobin in Sickle Cell Patients is Related to the Degree of Iron Overload||Baseline, 6 months and 12 months|||||||
2735459|NCT00981305|Secondary|Change of Vaginal Maturation Index|Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).|Baseline and 8 weeks||||vaginal maturation index||Standard Deviation|Mean
2735460|NCT00981305|Secondary|Change of Vaginal pH||Baseline and 8 weeks||||pH||Standard Deviation|Mean
2735461|NCT00981305|Secondary|Change of a Total and Other Five Domains of Female Sexual Function Index Score|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2735462|NCT00981305|Primary|Change of Pain Score of Female Sexual Function Index|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2735463|NCT00981292|Secondary|Number of Participants With Significant Modulation of Mood.|Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.|42 minutes|As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.|||Participants|||Number
2735464|NCT00981292|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.|42 minutes|If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.|||Participants|||Number
2735465|NCT00981292|Primary|Modulation of Levels of Total Haemoglobin|This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.|42 minutes|If NIRS readings were deemed not too affected by artefacts (usually caused by participants moving the headband in some way) then they were utilized in the analysis.|||μmol/L||Standard Error|Mean
2735466|NCT00981253|Secondary|Heart Rate Variability During Rest|Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during 5 minutes of normal relaxed breathing|At 12 weeks||||ln (ms^2)||95% Confidence Interval|Least Squares Mean
2735467|NCT00981253|Secondary|Baroreflex Sensitivity|Baroreflex sensitivity was obtained from beat-to-beat heart rate and blood pressure recorded from patients in the supine position with a Nexfin noninvasive blood pressure monitor.|At 12 weeks||||ms/mm Hg||95% Confidence Interval|Least Squares Mean
2735470|NCT00981253|Secondary|Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization.|Patients documented all medical encounters on an annual basis after enrollment. Medical records were reviewed, and events, categorized on the basis of American College of Cardiology/American Heart Association criteria. The following medical events were included: all-cause mortality, fatal and nonfatal myocardial infarction (MI), coronary or peripheral artery revascularization, stroke/transient ischemic attack, and unstable angina requiring hospitalization.|Baseline through Follow-up (median, 3.2 years)||||Participants|||Count of Participants
2735471|NCT00981253|Primary|Change From Baseline to 12 Weeks in Individual Scaled Scores|"Beck Depression Inventory II: 21-item scale used to measure depression. Scores range from 0 to 63, with higher scores suggesting greater depressive symptoms.~State-Trait Anxiety Inventory: 20-item scale which assess levels of state anxiety. Scores range from 20 to 80 with scores ≥40 suggesting clinically significant anxiety.~General Health Questionnaire:12-item measure of general distress. Scores range from 0 to 36, with higher scores indicating greater emotional distress.~Patient-Reported Outcomes Measurement Information System (PROMIS) Anger: 8-item scale which assesses anger. Scores range from 8 to 40, with higher scores indicating greater anger.~Perceived Stress Scale: 10-item measure of general distress and perceived ability to cope. Scores range from 0 to 40, higher scores indicate greater stress."|Baseline; 12 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2735472|NCT00981253|Primary|Absolute Composite Stress Score|A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2.|Baseline; 12 weeks||||Mean rank score||95% Confidence Interval|Least Squares Mean
2735473|NCT00981227|Other Pre-specified|Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose|"Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 no pain to 10 worst possible pain) NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting."|baseline and 13 weeks||||Points||Standard Error|Least Squares Mean
2735474|NCT00981227|Primary|Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain|"The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours.~Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:~Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation.~Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period."|baseline and 13 weeks||||Points||Standard Error|Least Squares Mean
2735475|NCT00981214|Secondary|Percentage of Stool With Visible Oil or Grease|Mean percentage of oil or grease at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of stools||Standard Deviation|Mean
2735476|NCT00981214|Secondary|Percentage of Blood in Stool|Mean percentage of stools with blood at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.|||percentage of stools||Standard Deviation|Mean
2735477|NCT00981214|Secondary|Physician's and Parent's or Legal Guardians Assessment of Improvement in Clinical Symptoms|Clinical symptoms of exocrine pancreatic insufficiency (EPI) were assessed by the physician and parent or guardian to determine if the participant showed improvement in symptoms of EPI at end of study after the dose stabilization period. EPI is a syndrome characterized by clinical symptoms of poor absorption of fats, proteins, and to a lesser extent, carbohydrates, which manifests primarily in patients with cystic fibrosis. Number of participants with improvement in clinical symptoms was reported.|Day 19 (end of study)|Analysis population set included all participants who received at least 1 dose of study.|||participants|||Number
2735478|NCT00981214|Secondary|Mean Number of Pain Symptoms|Symptoms of pain was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.|||pain symptoms per day||Standard Deviation|Mean
2735479|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||flatulences per day||Standard Deviation|Mean
2735507|NCT00981045|Primary|Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.|The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.|Day 120||||participants|||Number
2735508|NCT00981045|Primary|Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.||Day 56||||g/dL||Standard Deviation|Mean
2735480|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||bloatings per day||Standard Deviation|Mean
2735481|NCT00981214|Secondary|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery or overt diarrhea. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period) and Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of stools||Standard Deviation|Mean
2735482|NCT00981214|Primary|Percentage of Participants Who Were Responders After 2 Weeks of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30% fecal fat content) and without signs and symptoms of malabsorption after 2 weeks of treatment with study medication.|Day 18 (end of treatment)|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2735483|NCT00981214|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||stools per day||Standard Error|Mean
2735484|NCT00981214|Secondary|Change From Baseline in Weight at Day 12, 19||Baseline, Day 12, 19|Analysis population included all participants who received at least 1 dose of study medication.|||kilogram||Standard Deviation|Mean
2735485|NCT00981214|Primary|Percentage of Participants Who Were Responders After 1 Week of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.|Day 11|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2735486|NCT00981175|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.|Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.|Day 0 up to 28 post-vaccination|Treatment emergent adverse events were assessed in the Safety Population.|||Participants|||Number
2735487|NCT00981175|Primary|Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.|Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.|Days 0 to 28 post-vaccination|Injection site reactions were assessed in the Safety Population.|||Participants|||Number
2735488|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.|Month 24 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population|||Participants|||Number
2735489|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.|Month 12 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population|||Participants|||Number
2735490|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.|Month 6 pre- and post-vaccination|Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.|||Participants|||Number
2735491|NCT00981175|Primary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.|Day 28 post-vaccination|Immunogenicity was assessed in the Intent-to-Treat Population.|||Participants|||Number
2735492|NCT00981149|Secondary|Evoked Pain Via Algometry .|Assessment of evoked pain using digital palpation examination at 18 predefined bodily sites.|6 weeks||||Pain pressure threshold (kg/cm2)||Standard Deviation|Mean
2735493|NCT00981149|Primary|Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks.|Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).|1, 3, 6 weeks||||units on a scale||Standard Deviation|Mean
2735494|NCT00981084|Primary|Word Generation|Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||number of words generated||Standard Deviation|Mean
2735497|NCT00981084|Primary|Learning and Memory Measures.|"Testing was completed after first intervention and again after second intervention.~Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.~Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75).~RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15).~Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36).~BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12)."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||Items recalled||Standard Deviation|Mean
2735498|NCT00981058|Secondary|Number of Participants With a Serum Anti-Necitumumab Antibody Assessment|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.|Baseline through 31 Months|All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.|||participants|||Number
2735499|NCT00981058|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months|All randomized participants who received at least one dose of study drug and had evaluable data for PK.|||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2735500|NCT00981058|Secondary|Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|31 Months|All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.|||participants|||Number
2735501|NCT00981058|Secondary|Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable data for LCSS.|||millimeter (mm)||Standard Deviation|Mean
2735502|NCT00981058|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.|||units on a scale||Standard Deviation|Mean
2735503|NCT00981058|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.|Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20|||Months||95% Confidence Interval|Median
2735504|NCT00981058|Secondary|Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 31 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2735505|NCT00981058|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131|||months||95% Confidence Interval|Median
2735506|NCT00981058|Primary|Overall Survival Time (OS)|Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106|||Months||95% Confidence Interval|Median
2735509|NCT00981019|Secondary|Number of Physicians (= Participants) Assuming a Benefit of Screening|Physicians are faced with four different medical statistics about the effect of screening (e.g., 5-year survival) within four successive scenarios and after each scenario asked whether they assume the screening to be beneficial given the statistical information. Options to answer are: yes, no, can't decide. If yes, then participants are further asked to describe this benefit by the following categories: Very large, large, moderate, small, very small.|25 minutes (mean duration of the survey)||2011-08-31|08/2011||||
2735510|NCT00981019|Primary|Number of Physicians (=Participants) Recommending the Screening|The aim of the study was to learn how different medical cancer screening statistics would influence doctors' recommendation behavior and their effectiveness judgments of screening tests. For that reason the online survey study presented physicians with four different medical statistics (e.g., 5-year survival) within four successive scenarios and asked after each scenario whether they would recommend the screening to a (hypothetical) patient given the data. Options to answer are: Definitely yes, Probably yes, Probably no, Definitely no, Can't decide.|25 minutes (mean duration of the survey)|We calculated that a sample size of 300 physicians was needed to have 90% power to detect differences of 20% or higher in the proportion of respondents correctly answering questions about the different cancer statistics (2-sided alpha of .05).|||participants|||Number
2735511|NCT00980980|Secondary|Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates|Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC >4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital.|25-month time frame represents 7-month baseline and 18-month intervention periods|The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.|||MRSA isolates non-susceptible to CHG|MRSA+ isolates||Number
2735512|NCT00980980|Secondary|Intervention Impact on Mupirocin Susceptibility of MRSA Isolates|Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital.|25-month time frame represents 7-month baseline and 18-month intervention periods|The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.|||Odds Ratio|MRSA+ isolates|95% Confidence Interval|Number
2735513|NCT00980980|Secondary|Intervention Impact on Bacteriuria and Candiduria|Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL.|30-month time frame represents 12-month baseline and 18-month intervention periods.|The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm.|||Hazard Ratio||95% Confidence Interval|Number
2735514|NCT00980980|Secondary|Blood Culture Contamination Rates|Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.|24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.|The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm.|||Odds Ratio||95% Confidence Interval|Number
2735515|NCT00980980|Secondary|Intervention Impact on Healthcare Costs|Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).|12-month period|Annual adult ICU admissions per hospital, over the course of 1 year.|||Dollars per 1000 ICU-admissions|||Number
2735516|NCT00980980|Secondary|ICU-attributable All-pathogen Bloodstream Infection|Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.|||Hazard ratio||95% Confidence Interval|Number
2735517|NCT00980980|Secondary|MRSA Bloodstream Infection|Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.|||hazard ratio||95% Confidence Interval|Number
2735518|NCT00980980|Primary|Main Outcome: Patients With Nosocomial MRSA Clinical Cultures|Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.|||hazard ratio||95% Confidence Interval|Number
2735519|NCT00980798|Secondary|The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event|The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.|At each study visit from baseline until week 16|Safety population: All randomised patients who received at least one dose of study drug.|||participants|||Number
2735565|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735520|NCT00980798|Primary|Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)|"The analgesic effect was assessed by the BPI item 5 pain on average using a 0 to 10 numeric rating scale, with 0 being no pain and 10 being pain as bad as you can imagine."|At each study visit from screening to week 16|The primary population for the efficacy analyses was the intention to treat (ITT) population: all randomised patients who received at least one dose of study drug excluding patients who had no post-baseline efficacy data. This population included patients who discontinued early owing to lack of efficacy or other reasons.|||units on a scale||Standard Deviation|Mean
2735521|NCT00980746|Primary|Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain|﻿Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.|17 weeks||||units on a scale||Standard Error|Least Squares Mean
2735522|NCT00980681|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared|1 to 7 days||||percentage of non-assessable segments|||Number
2735523|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735524|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735525|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735526|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735527|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735528|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735529|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735530|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2735531|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.|1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
2735532|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
2735533|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
2735566|NCT00980330|Secondary|The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment|The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.|Weeks, 2, 4, 8, and 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735707|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.|||Participants|||Number
2735534|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
2735535|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2735536|NCT00980655|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.|||fold rise||95% Confidence Interval|Geometric Mean
2735537|NCT00980642|Secondary|Specificity for Detection of Hypothermia|Hypothermia will be defined as a temperature < 36 Celsius degree|From anesthesia induction to the end of surgery||||percent of non-hypothermias||95% Confidence Interval|Number
2735538|NCT00980642|Secondary|Sensitivity for Detection of Hypothermia|Hypothermia is defined as a temperature < 36 Celsius degree|From anesthesia induction to the end of surgery||||percent of hypothermias||95% Confidence Interval|Number
2735539|NCT00980642|Primary|The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature|Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.|From anesthesia induction to the end of surgery||||Celsius degree||95% Confidence Interval|Mean
2735540|NCT00980590|Secondary|Incidence of Intubation Complications|Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation|Intubation period||||cases|||Number
2735541|NCT00980590|Secondary|Number of Intubation Attempts||Intubation period||||times|||Number
2735542|NCT00980590|Secondary|Overall Intubation Success Rate||Intubation period||||Percentage of overall intubation|||Number
2735543|NCT00980590|Primary|Intubation Time|For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time.|The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.|Patients with number of intubation attempt no more than 3|||seconds||Standard Deviation|Mean
2735544|NCT00980395|Secondary|Partial Response||Two years||||Participants|||Count of Participants
2735545|NCT00980395|Secondary|Complete Response Rate||Two years||||Participants|||Count of Participants
2735546|NCT00980395|Secondary|Overall Survival at 2 Years||2 years||||Participants|||Count of Participants
2735547|NCT00980395|Primary|Progression-free Survival at 2 Years|PFS was calculated from the first dose of study drug to the first documentation of disease progression, death regardless of cause, or change in therapy due to disease progression, whichever occurred first. If disease progression did not occur by the end of treatment, patients were evaluated every 3 months until progression with physical examination, laboratory studies, and conventional computed tomographic imaging, up to a maximum of 2 years. The Kaplan-Meier product-limit method will be used to estimate progression-free survival in the presence of censoring.|2 years||||Participants|||Count of Participants
2735548|NCT00980343|Secondary|Determine Drug Effect (Pharmacokinetics) in Plasma for Arm 1|samples collected pre tumor resection (day of surgery) and post-tumor resection (day of surgery|Day of surgery||||ng/ml||Standard Deviation|Median
2735549|NCT00980343|Secondary|Changes in Sonic Hedgehog Pathway Activation|determined by Reverse transcription polymerase chain reaction (RT-PCR) and immunohistochemistry (IHC) (Gli-1, Gli-2, PATCH (PTCH-1b)|Pre-tumor resection and post tumor resection (12 hours)|only small number of samples and thus not enough to give useful information. Samples not processed for outcome and analysis was not performed. No numerical data to report||||||
2735550|NCT00980343|Secondary|Incidence of CD133+ Neurospheres by Arm|number of tumor-derived CD133 neurospheres undergoing proliferation and self-renewal|12 hours post-vismodegib administration||||percent of CD133 Neuospheres|||Number
2735551|NCT00980343|Secondary|Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0|NCI CTCAE grade 3 or 4 possible, probable or definitely related events Grade 3 - severe Grade 4 - life threatening|30 days from last dose of drug treatment - 1.5 years||||percent of participants|||Number
2735552|NCT00980343|Secondary|Best Tumor Response Assessed by the Modified Macdonald Radiographic Response Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|evaluated every 8 weeks - 1 year|3 subjects not evaluable for radiographic response Arm 1 and 4 subjects not evaluable for radiographic response in Arm 2|||participants|||Number
2735553|NCT00980343|Secondary|Overall Survival Time|The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.. Start date based on onset of treatment.|3 years||||months||95% Confidence Interval|Median
2735554|NCT00980343|Primary|6 Months Progression-free Survival (PFS)|Estimated using Kaplan Meier curves. six months calculated from date of treatment onset post-operatively. MRI scan at 6 months must be free of progression Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.|6 months||||percentage of patients||95% Confidence Interval|Number
2735555|NCT00980330|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng.h/mL||Full Range|Median
2735556|NCT00980330|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng/mL||Full Range|Median
2735557|NCT00980330|Secondary|The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735558|NCT00980330|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.|Up to Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735559|NCT00980330|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735560|NCT00980330|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.|Week 60|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735561|NCT00980330|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma levels of Hepatitis C virus ribonucleic acid at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735562|NCT00980330|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735563|NCT00980330|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.|Week 4|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735564|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of Participants|||Number
2735687|NCT00979459|Secondary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event||up to 8 days|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.|||participants|||Number
2735567|NCT00980330|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)|The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.|Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
2735568|NCT00980278|Secondary|Final Bone Volume: Initial Graft Volume Ratio|Bone volume fraction of bone core histological and µCT analyses|4 months||||ratio||Standard Deviation|Mean
2735569|NCT00980278|Secondary|Change in Sinus Bone Volume|CBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity|Pre-baseline and within 2 weeks of 4 Month visit||||cm3||Standard Deviation|Mean
2735570|NCT00980278|Primary|Bone Volume Fraction of Bone Core|Bone volume fraction of bone core histological and µCT analyses|4 months||||ratio||Standard Deviation|Mean
2735571|NCT00980278|Secondary|Change in Linear Radiographic Bone Height|Change in linear radiographic bone heights were measured before and after bone graft reconstruction|Screening and 1 week post-op from baseline||||mm||Standard Deviation|Mean
2735572|NCT00980278|Primary|Bone Mineral Density of Bone Core|Bone mineral density of bone core was measured by histological and µCT analyses|4 months||||mg/mm^3||Standard Deviation|Mean
2735573|NCT00980200|Secondary|Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2735574|NCT00980200|Primary|Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|Intent-to Treat (ITT) Population: all participants randomized to treatment who received at least one dose of trial medication. Randomized participants were assumed to have received trial medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2735575|NCT00980174|Secondary|Serum Type 1 Collagen C-telopeptide (CTX) Percent Change From Baseline at Day 15||From Baseline to Day 15||||Percent||Inter-Quartile Range|Median
2735576|NCT00980174|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
2735577|NCT00980174|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
2735578|NCT00980174|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
2735579|NCT00980174|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
2735580|NCT00980174|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|Subjects with baseline and at least one post baseline measurements|||Percent||95% Confidence Interval|Mean
2735581|NCT00980148|Secondary|Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.||Baseline and study visit #2 (Day 28 after therapy is started)|||||||
2735582|NCT00980148|Primary|Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.|The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).|Study visit # 2 (Day 28 after therapy started)|The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.|||percentage of participants|||Number
2735583|NCT00980057|Secondary|Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)|The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.|baseline to six month visit||||units on a scale||Standard Deviation|Mean
2735584|NCT00980057|Secondary|Change in Distance Walked During the Six Minute Hall Walk||baseline to six month visit||||meters||Standard Deviation|Mean
2735688|NCT00979459|Secondary|Number of Participants Who Experienced at Least One Adverse Event||Through 30 days post-dose|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.|||participants|||Number
2735689|NCT00979459|Primary|Maximum Plasma Concentration (Cmax) for MK-1006|Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose||||nM||95% Confidence Interval|Geometric Mean
2735585|NCT00980057|Secondary|Change in New York Heart Association (NYHA) Classification|"The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity.~Class - Patient Symptoms I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~IV- Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|baseline to six month visit||||NYHA class||Standard Deviation|Mean
2735586|NCT00980057|Secondary|Change in Left Ventricular Ejection Fraction (LVEF)||baseline to six month visit||||percent||Standard Deviation|Mean
2735587|NCT00980057|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVi)|Change in left ventricular end systolic volume index (LVESVi).|baseline to six month visit||||milliliters per meter squared||Standard Deviation|Mean
2735588|NCT00980057|Secondary|Right Ventricular Pacing Percentage|The percentage of time the right ventricle is paced by the device|implant to six months post randomization||||percentage of right ventricle pacing||Standard Deviation|Mean
2735589|NCT00980057|Primary|Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)|For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (>60 ms)|randomization to 6 months post randomization|17 participants did not have data available for analysis of this endpoint.|||Participants|||Count of Participants
2735590|NCT00980057|Primary|Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings|Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.|randomization visit and six month visit|Concordance correlations have been calculated between AoVTI at Adaptive CRT AV and VV settings vs. echo-optimized AV and VV settings at randomization and 6 M. Paired AoVTI measurements were used for concordance correlation analysis, where each subject served as his/her own control. AoVTI was not obtained at both settings for 79 patients.|||Concordance correlation coefficient||95% Confidence Interval|Number
2735591|NCT00980057|Primary|Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score|"Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant~Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse"|randomization to six month visit||||Participants|||Count of Participants
2735592|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 8-13 (all groups now on placebo)|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean number of doses/day across the days listed.|||mean # of doses per day||Standard Error|Mean
2735593|NCT00980044|Primary|Subjective Opioid Withdrawal Adjective Total Score Week 2|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present|days 8-13|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean total withdrawal score across the days listed.|||units on a scale||Standard Error|Mean
2735594|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 1-7|These are data from week 1 -- the 12 people who completed this week in each group. This is the analysis that was specified at the start of the study. The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.|||Mean doses per day||Standard Error|Mean
2735595|NCT00980044|Primary|Subjective Opioid Withdrawal Total Adjective Score|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T|Days 1-7|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.|||units on a scale||Standard Error|Mean
2735596|NCT00980005|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735597|NCT00980005|Secondary|Number of Subjects Reporting Medically Attended Adverse Events (MAEs).|For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2736730|NCT00974259|Secondary|Adherence to PbtO2 and ICP-directed Treatment Protocol|"Number of protocol deviations and violations for ICP/PbtO2 group and ICP only group.~The unit of measure for this outcome is number of events, where an event can be either a deviation or a violation."|5 days||||Events (sum of deviations & violations)|||Number
2735598|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.~Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735599|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735600|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.|"Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.~Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735601|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|"Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.~Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735602|NCT00980005|Secondary|Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).~Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.~Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.~Related = symptom assessed by the investigator as causaly related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735603|NCT00980005|Secondary|Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).~Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.~Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.~Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.~Related = symptom assessed by the investigator as causally related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2735604|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.~Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Fold change||95% Confidence Interval|Mean
2735605|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.~Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Fold change||95% Confidence Interval|Mean
2735606|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Participants|||Count of Participants
2735607|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Participants|||Count of Participants
2735608|NCT00980005|Secondary|Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Participants|||Count of Participants
2735609|NCT00980005|Secondary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs).~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2735610|NCT00980005|Primary|Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Participants|||Count of Participants
2735611|NCT00980005|Primary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2735612|NCT00979992|Other Pre-specified|Changes in Serum and Plasma Angiogenesis Markers by Enzyme-linked Immunosorbent Assays||Baseline to up to 5 years|||||||
2735613|NCT00979992|Other Pre-specified|Change in Pro-angiogenic Protein Levels||Baseline to up to 5 years|||||||
2735614|NCT00979992|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTC AE v 4.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.|Eligible and treated patients|||participants|||Number
2735615|NCT00979992|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter for up to 5 years.|Eligible and treated patients.|||months||90% Confidence Interval|Median
2735616|NCT00979992|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, for a total duration of 8.25 years|Eligible and treated patients.|||months||90% Confidence Interval|Median
2735617|NCT00979992|Primary|The Percentage of Patients Who Survive Progression Free for at Least 6 Months|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2735618|NCT00979992|Primary|Objective Tumor Response Rate (Complete and Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2735619|NCT00979953|Primary|Change From Baseline in the Average Pain Score (NPRS) for Week 2|The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.|Baseline, Week 2|All participants who received at least 1 dose of study medication and had at least evaluable 1 NPRS postdose measurement. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.|||units on a scale||Standard Deviation|Least Squares Mean
2735620|NCT00979940|Primary|Periprocedural Myonecrosis||16-24 hours post PCI||||participants|||Number
2735621|NCT00979901|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2|Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2735622|NCT00979901|Secondary|Physician's Global Evaluation of Allergic Rhinitis at Week 2|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2735623|NCT00979901|Secondary|Patient's Global Evaluation of Allergic Rhinitis at Week 2|"An evaluation by the patient, administered at the last visit (or~upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the~study. Scores were measured as 0 (best) to 6 (worst)."|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2735624|NCT00979901|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2735625|NCT00979901|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2735626|NCT00979901|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily~on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal~Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The primary efficacy analysis was based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2735627|NCT00979875|Secondary|Time to Percentage of Total Insulin Exposure|Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + rHuPH20, Glulisine alone, Glulisine + recombinant human hyaluronidase PH20 (rHuPH20), Aspart alone, or Aspart + rHuPH20 with evaluable total insulin exposure data.|||minutes||Standard Deviation|Mean
2735628|NCT00979875|Secondary|Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)|Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.|Predose up to 120 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20) , Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-t data.|||percentage of total AUC||Standard Deviation|Mean
2735629|NCT00979875|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tGIR(max) data.|||minutes||Standard Deviation|Mean
2735690|NCT00979459|Primary|Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006|AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose||||nM*hr||95% Confidence Interval|Geometric Mean
2735630|NCT00979875|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable t(50%max) data.|||minutes||Standard Deviation|Mean
2735631|NCT00979875|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tmax data.|||minutes||Standard Deviation|Mean
2735632|NCT00979875|Primary|Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)|Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.|Predose up to 60 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-60 data.|||minutes*nanomolars (min*nM)||Standard Deviation|Mean
2735633|NCT00979654|Secondary|Number of Participants With Positive Anti-Drug Antibody|Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.|Day 1 and Week 12, 24, 52, 104, 156 and 168|Safety Population included all participants who received at least one dose of investigational product.|||Participants|||Number
2735634|NCT00979654|Secondary|Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||ratio||Standard Deviation|Mean
2735635|NCT00979654|Secondary|Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab|The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2735636|NCT00979654|Secondary|Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab|The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||microgram.day per milliliter(mcg*day/mL)||Standard Deviation|Mean
2735637|NCT00979654|Secondary|Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2735638|NCT00979654|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab|The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||days||Standard Deviation|Mean
2735639|NCT00979654|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab|The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||days||Full Range|Median
2735640|NCT00979654|Secondary|Maximum Observed Serum Concentration (Cmax) for Sifalimumab|The Cmax is the maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2735641|NCT00979654|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until week 182|Safety Population included all participants who received at least one dose of investigational product.|||participants|||Number
2735691|NCT00979420|Secondary|Number of Participants With Drug Related Adverse Events|Number of participants with drug related Adverse Events (AEs)|Up to 185 months|Treated set|||participants|||Number
2735642|NCT00979628|Secondary|Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments|Effective Glycemic control is also assessed by number of hypoglycemia events among the patients treated with Basal plus, basal-bolus and SSRI treatments. Hypoglycemia event is defined as blood glucose levels <70 mg/dL. Number of patients with hypoglycemia episodes that are treated with Basal plus, basal-bolus and SSRI treatment regimens during their hospital stay are examined and compared.|During hospital stay, up to 12 days||||participants|||Number
2735643|NCT00979628|Primary|Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments|The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG >126 mg/dl or random BG >200 mg/dl on two or more occasions).|Randomization and 24 hrs after treatment||||mg/dL||Standard Deviation|Mean
2735644|NCT00979615|Secondary|Mean Change in Sneezing Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks||||Units on a scale||Standard Deviation|Mean
2735645|NCT00979615|Secondary|Mean Change Nasal Congestion Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks||||Units on a scale||Standard Deviation|Mean
2735646|NCT00979615|Secondary|Mean Change Postnasal Drip Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks||||Units on a scale||Standard Deviation|Mean
2735647|NCT00979615|Secondary|Mean Change in Rhinorrhea Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week||||Units on a scale||Standard Deviation|Mean
2735648|NCT00979615|Primary|Mean Change in 2-week rTNSS From Baseline|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week||||Units on a scale||Standard Deviation|Mean
2735649|NCT00979602|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2735650|NCT00979602|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2735651|NCT00979602|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2736731|NCT00974259|Secondary|Total Number Participants With Adverse Events Associated With PbtO2 Monitoring.|Total number participants with PbtO2 directed intervention-related Serious Adverse Events|5 days||||participants|||Number
2735652|NCT00979602|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2735653|NCT00979602|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).|At Days 7 and 21|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2735654|NCT00979602|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2735655|NCT00979602|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2735656|NCT00979602|Secondary|Number of ILI Symptoms in All Reported ILI Cases|Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.|From Day 14 post-vaccination through the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
2735657|NCT00979602|Secondary|Number of ILI Symptoms in All Reported ILI Cases|Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.|From Day 0 up to the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
2735658|NCT00979602|Secondary|Number of A/California Influenza Related Cases|Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.|From Day 0 up to the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
2735659|NCT00979602|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2735660|NCT00979602|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2735661|NCT00979602|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Participants|||Count of Participants
2735662|NCT00979602|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Participants|||Count of Participants
2735663|NCT00979602|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Participants|||Count of Participants
2735664|NCT00979602|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Participants|||Count of Participants
2735665|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
2735666|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Participants|||Count of Participants
2735667|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Titers||95% Confidence Interval|Geometric Mean
2735668|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Participants|||Count of Participants
2735669|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Titers||95% Confidence Interval|Geometric Mean
2735670|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|"Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.~The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance."|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
2735671|NCT00979602|Primary|Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases|The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.|From Day 14 post-vaccination up to study end (at Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
2735672|NCT00979602|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2735673|NCT00979602|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
2735674|NCT00979602|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
2735675|NCT00979602|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
2735676|NCT00979576|Secondary|Cmax of Pemetrexed|Maximum measured concentration of pemetrexed in plasma (Cmax)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735677|NCT00979576|Secondary|AUC0-inf of Pemetrexed|Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2735678|NCT00979576|Secondary|Cmax of Nintedanib|Maximum measured concentration of nintedanib in plasma (Cmax)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735679|NCT00979576|Secondary|AUC0-inf of Nintedanib|Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|Pharmacokinetic (PK) set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2735680|NCT00979576|Secondary|Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set|||participants|||Number
2735681|NCT00979576|Secondary|Duration of Disease Control|Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.|From first study drug administration until PD or death, up to 1003 days|Patients from the treated set who achieved disease control|||Days||Full Range|Median
2735682|NCT00979576|Secondary|Disease Control Rate|Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set|||Participants|||Number
2735683|NCT00979576|Secondary|Overall Response Rate|Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set|||Participants|||Number
2735684|NCT00979576|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.~CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE)."|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set|||participants|||Number
2735685|NCT00979576|Primary|Dose Limiting Toxicities|Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course|During the first course, 21 days|Treated set|||Participants|||Number
2735686|NCT00979550|Primary|Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)|Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software|3 months|||||||
2735692|NCT00979420|Secondary|Course of Absolute CD4+ Cell Count|The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years|||CD4+ cells/mm3||Full Range|Median
2735693|NCT00979420|Secondary|History of Therapy With Antiretroviral Medication|Participants with a history of therapy with antiretroviral medication.|Baseline|Treated set|||participants|||Number
2735694|NCT00979420|Secondary|Duration of Intake of Viramune|Duration of intake of Viramune|End of treatment, up to 185 months|Treated set|||months||Full Range|Median
2735695|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.|||Participants|||Number
2735696|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.|||Participants|||Number
2735697|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST|||Participants|||Number
2735698|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT|||Participants|||Number
2735699|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose|||Participants|||Number
2735700|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.|||Participants|||Number
2735701|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.|||Participants|||Number
2735702|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.|||Participants|||Number
2735703|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.|||CD4+ cells/mm3||Full Range|Median
2735704|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.|||Participants|||Number
2735705|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.|||log10 copies/ml||Full Range|Median
2735706|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.|||CD4+ cells/mm3||Full Range|Median
2735708|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.|||log10 copies/ml||Full Range|Median
2735709|NCT00979407|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2735710|NCT00979407|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2735711|NCT00979407|Secondary|Number of Subjects With Any Adverse Event of Special Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2735712|NCT00979407|Secondary|Number of Subjects With pIMDs|A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2735713|NCT00979407|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2735714|NCT00979407|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2735715|NCT00979407|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
2735716|NCT00979407|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2735717|NCT00979407|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
2735718|NCT00979407|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Fold increase||95% Confidence Interval|Geometric Mean
2735719|NCT00979407|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
2736732|NCT00974259|Primary|Fraction of Time That Brain Oxygen Levels Are Below the Critical Threshold of 20 mm Hg .|Proportion of time PbtO2 below 20 mm Hg|5 days||||Proportion||Standard Deviation|Mean
2735720|NCT00979407|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Participants|||Count of Participants
2735721|NCT00979407|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.|||Participants|||Count of Participants
2735722|NCT00979407|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Titers||95% Confidence Interval|Geometric Mean
2735723|NCT00979407|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2735724|NCT00979407|Secondary|Number of SCR Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Participants|||Count of Participants
2735725|NCT00979407|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.|||Participants|||Count of Participants
2735726|NCT00979407|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received 1 vaccine dose and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2735727|NCT00979303|Secondary|Total Radiation Exposure|Total radiation exposure measured in mGy|During Ablation Procedure||||mGy||Full Range|Median
2735728|NCT00979303|Primary|Total Fluoroscopy Time|Total fluoroscopy time in minutes|During the Ablation procedure||||minutes||Full Range|Median
2735729|NCT00979212|Secondary|Response Rate|Patients are assessed for best response to protocol treatment using the RECIST criteria. The response rate was calculated as the number of patients who have a complete response (CR) or partial response (PR) divided by the total number of analyzable patients at completion of induction chemoradiation +/- panitumumab and prior to anticipated surgery in each arm. Patients without a documented assessment are considered as not having a CR or PR. Rates are not compared across arms.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2735730|NCT00979212|Secondary|Ability of FDG-PET/CT Scan Data to Predict Outcome||Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|FDG-PET/CT scan data was not obtained and therefore this outcome measure cannot be reported.||||||
2735731|NCT00979212|Secondary|Surgical Morbidities in Patients With Resectable Disease at Reassessment|A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.|From date of surgery to 30 days following surgery.|All eligible patients who started study treatment and received protocol surgery|||percentage of patients||95% Confidence Interval|Number
2735748|NCT00979134|Secondary|AUC(0-infinity)|To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.|"PK samples out to 96 hours 0 to 96 hours post-dose after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing."|PK|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2756302|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2735732|NCT00979212|Secondary|Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Does not include surgical morbidities. An acute adverse event is defined as any grade 3 or worse toxicity occurring during protocol treatment and within 30 days from the end of protocol treatment that is possibly, probably, or definitely related to treatment. Acute adverse events are any adverse events occurring within 30 days of the end of all protocol treatment. Late adverse events are any adverse events occurring after 30 days after the end of all protocol treatment.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2735733|NCT00979212|Secondary|Patterns of First Failure|The first failure site will be tabulated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment|||participants|||Number
2735734|NCT00979212|Secondary|Overall Survival|Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2735735|NCT00979212|Primary|Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.|The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2735736|NCT00979199|Secondary|Cost-benefit and Cost-effectiveness Analysis|Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point.|3 months|||||||
2735737|NCT00979199|Primary|Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement|The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).|3 months from enrollment||||participants|||Number
2735738|NCT00979134|Primary|Number of Participants With at Least 1 Causally Related SAE|To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547|SAEs are continually monitored from screening to end of 30 FU period||||Number of participants|||Number
2735739|NCT00979134|Primary|Number of Participants Who Experienced at Least One SAE|To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.|Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.||||Number of participants|||Number
2735740|NCT00979134|Primary|Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3|To investigate the safety and tolerability of AZD4547|Ongoing up to discontinuation up to 30 day FU.||||Participants|||Number
2735741|NCT00979134|Primary|Number of Participants With at Least 1 AE of CTCAE >=G3|To investigate the safety and tolerability of AZD4547|Ongoing up to discontinuation up to 30 day FU.||||Participants|||Number
2735742|NCT00979134|Primary|Number of Participants Who Experienced at Least 1 Causally Related AE.|To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.|AEs are continually assessed from screening up to 30 day FU period||||Participants|||Number
2735743|NCT00979134|Primary|Number of Patients Who Experienced at Least 1 AE|To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.|AEs are monitored from screenng through to 30 day follow up period||||Participants|||Number
2735744|NCT00979134|Secondary|AUC,ss(0-infinity)|To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.|"PK samples out to 96 hours 0-96 hours post dose after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing."|PK|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2735745|NCT00979134|Secondary|Css,Max (ng/mL)|To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.|"PK samples out to 96 hours 0-96 hours post-dose after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing."|PK|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735746|NCT00979134|Secondary|Cmax (ng/mL)|To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.|"PK samples out to 96 hours 0-96 hours post dose after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing."|PK|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2735747|NCT00979134|Secondary|Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)|To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is >=30% reduction in sum of longest diameter of target lesions|Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.|Efficacy/Tumour response: All dosed patients meeting the final FISH 6 score criteria with a baseline tumour assessment and had a FGFR1 FISH ratio ≥2 if the patient was from Part C|||Patients|||Number
2735749|NCT00979121|Other Pre-specified|Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14|CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis.|6 and 14 days after randomization||||mg/dL||Standard Deviation|Mean
2735750|NCT00979121|Other Pre-specified|Other Secondary Out-comes|Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured.|28 days after randomization||||percentage of participants||95% Confidence Interval|Number
2735751|NCT00979121|Other Pre-specified|ICU Free Days to Day 28||28 days after randomization||||days||Standard Deviation|Mean
2735752|NCT00979121|Other Pre-specified|Organ Failure Free Days at Day 14|The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function.|14 days after randomization||||days||Standard Deviation|Mean
2735753|NCT00979121|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28 after study randomization||||days||Standard Deviation|Mean
2735754|NCT00979121|Primary|Hospital Mortality to Day 60.|The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization||||percentage of participants||95% Confidence Interval|Number
2735755|NCT00979069|Primary|Executive Language Functions|The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, & Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct|number of correct words at pre and post separated by 12 weeks||||Mean outpoint by group at pre and post||Standard Deviation|Mean
2735756|NCT00979017|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat|||months||95% Confidence Interval|Median
2735757|NCT00979017|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, worsening T2/FLAIR, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat|||months||95% Confidence Interval|Median
2735758|NCT00979017|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of treatment-related, grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat|||participants|||Number
2735759|NCT00979017|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage and Systemic Hemorrhage|Incidence and severity of CNS hemorrhage and systemic hemorrhage- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat|||participants|||Number
2735760|NCT00979017|Primary|Response Rate|The percentage of participants with a complete or partial response as determined by a modification of the Response Assessment in Neuro-Oncology (RANO) criteria. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Per the criteria, confirmation of response was required. Response rate = CR+PR.|4 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2735761|NCT00978757|Primary|The Effect of Ketamine on Interleukin 6 (IL-6) Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)|As an outcome, Interleukin 6 (IL-6) was measured in plasma concentration of hepatic resections requiring temporary porto-arterial occlusion patients.|Plasma concentration of IL-6 levels were obtained prior to surgery, upon placement of the first intravenous||||pg/ml||Standard Deviation|Mean
2735762|NCT00978731|Secondary|Median Number of Months of Overall Survival (OS) (Kaplan Meier Method)|Overall survival was defined as the median number of months from baseline to death from any cause.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||months||95% Confidence Interval|Median
2735763|NCT00978731|Secondary|Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||months||95% Confidence Interval|Median
2735764|NCT00978731|Secondary|Number of Participants With Best Cytogenetic Response|Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: >0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: >35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: >65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: >95% to 100% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.|||participants|||Number
2735765|NCT00978731|Primary|Number of Participants With Dose Interruptions and Dose Reductions|Dose interruptions and reductions were allowed, in order to optimize individual participant's hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times.|From start of study to final assessment (up to 32.2 months).|All treated participants.|||participants|||Number
2735766|NCT00978731|Secondary|Median Number of Months of Major Cytogenetic Response (MCyR)|MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had MCyR (13 participants had MCyR in QD group and 9 in BID group). Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.|||months||95% Confidence Interval|Median
2735767|NCT00978731|Primary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; Calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; Bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN; Creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-<0.8 or >2.46-6.6mEq/L, Grade 4: <0.6 or >6.6mEq/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
2735768|NCT00978731|Secondary|Number of Participants With Major Cytogenetic Response (MCyR)|Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.|||participants|||Number
2735769|NCT00978731|Secondary|Median Number of Months of CHR (Kaplan Meier Method)|CHR: WBC<=ULN (range: 9.29-12.5*10^3 c\uL); ANC >=1000/mm^3;Platelets <450000/mm^3,no blasts/promyelocytes in peripheral blood; <5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood <20% & no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had CHR. Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.|||months||95% Confidence Interval|Median
2735770|NCT00978731|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR should meet all of the following criteria: WBC <= Institutional ULN; ANC >= 1000/mm^3 ; Platelets < 450 000/mm^3 , no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood < 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants. Data was not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.|||participants|||Number
2735771|NCT00978731|Primary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
2735772|NCT00978731|Primary|Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
2735786|NCT00978562|Secondary|Number of Enhancing Lesions|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
2735773|NCT00978731|Primary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
2735774|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 53 + 7 days of follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2735775|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects, FPG values were missing.|||mmol/L||Standard Deviation|Mean
2735776|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735777|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735778|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735779|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2735780|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 22 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2735781|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2735782|NCT00978627|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2735783|NCT00978562|Secondary|Volume of Enhancing Lesions|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
2735784|NCT00978562|Secondary|Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
2735785|NCT00978562|Secondary|Tumor Vascularity|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
2735788|NCT00978562|Primary|Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent|Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.|up to 2 years||||min^-1||Standard Deviation|Mean
2735789|NCT00978562|Primary|Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol|Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).|Up to 2 years||||mL/g||Standard Deviation|Mean
2735790|NCT00978445|Secondary|Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire|"we are interested in the relative measure of quality of life by comparing quality of life measures through use of PSQ-18 and other measures listed.~Higher scores indicate a better quality of life."|During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3|power analysis|||scores on a scale||Standard Deviation|Mean
2735791|NCT00978445|Primary|Time Spent Per PT/INR Monitoring Encounter|minutes spent measuring coagulation time of blood on standard versus home protocol|Once per week during 12 week study|through minimum power study|||minutes||Standard Deviation|Mean
2735792|NCT00978432|Secondary|Evaluate the Association of Observed Response to the Doublet With the Response Predicted by Molecular Signatures for Activated B Cell Like (ABC) DLBCL and for Germinal Center B Cell Like (GCB) DLBCL.|"Response rates seen in subjects with activated B cell like DLBCL and for Germinal center B cell like DLBCL will be reported and assessed to see if GCB is associated with improved outcomes compared to ABC in subjects with relapsed disease who have received RAD + LBH. We will estimate the association of the ABC and GCB with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses.~The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis."|up to 13 cycles of therapy; approximately 1 year|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.||||||
2735793|NCT00978432|Secondary|Distribution of Change Across Time of mTOR and HDAC-I Inhibition From Baseline Until After the 1st 2 Cycles of Study Drug in Patients Who Received LBH and RAD.|Serum markers will be measured on the first day of cycle 1 and on the first day of cycle 3. The distribution of change across time in a marker will be summarized.|after 2 cycles of study therapy; up to 8 weeks|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, serum marker analysis was not performed and no results are available.||||||
2735794|NCT00978432|Secondary|Summary of Adverse Events (AEs)|Counts of adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose) experienced by patients on study drug(s). National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) is used to assess severity. Relatedness to study drug is assessed by the investigator.|From the time of first dose of study drug until 4 weeks after participant has stopped study drug; up to 1 year|Participants who consented to the study and took study drug were analyzed for this outcome measure. Total number of events per CTCAE v4 category per arm are reported if more than one event occurred.|||events|||Number
2735795|NCT00978432|Primary|Assessment of Association Between Observed Response to RAD001 and LBH589 and the Response Predicted by Molecular Signatures Developed in Our Pre-clinical Model|We will estimate the association of the molecular signature-predicted response to the doublet (CR+PR) with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses. Contingency tables will be used to present these associations.|From the start of combination therapy until a maximum of 2 years after completion of therapy|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.||||||
2735796|NCT00978432|Primary|Overall Response Rate|Overall Response Rate is the number of participants with a partial and complete response assessed by the Updated Cheson criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. If a subject has residual lesions on CT scan and the disease was fluorodeoxyglucose (FDG) avid pre-treatment, then that subject will be considered to be in a complete response. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|after 2 cycles of each study drug or after 2 cycles of doublet, up to 24 weeks|Patients have to be on each drug for at least 2 cycles to be evaluable for response.|||participants|||Number
2735797|NCT00978419|Secondary|Determine the Prevalence of Functional Impairment in Burn Patients and by Study Group||90 days|||||||
2735798|NCT00978419|Secondary|Determine the Prevalence of De-novo Long-term Neurocognitive Impairment in Burn Patients and by Study Group.||90 days|||||||
2735799|NCT00978419|Secondary|Determine the Prevalence of Delirium in the Two Subgroup of Patients||28 days|||||||
2735800|NCT00978419|Secondary|Determine Which Are Appropriate Attainable Endpoints for Future Trials and the Number of Participants Required to Reach Significance in Analysis of a Variety of Variables||28 days|||||||
2735801|NCT00978419|Secondary|Determine the Safety of Rosuvastatin Compared to Placebo in Burn Patients by Comparing the Frequency, Type and Severity of Adverse Events||28 days|||||||
2735802|NCT00978419|Secondary|A Reduction in ALT Levels Over Time, Compared to Placebo, Measured at Baseline, Days 1, 7, 14, 21, 28||28 days|||||||
2735809|NCT00978380|Secondary|Antibody and Inhibitor Development|All subjects who received rFXIII were monitored for anti-rFXIII antibodies and inhibitor development. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. Percentage of subjects with antibody and inhibitor development were reported.|From week 0 to week 52|The safety analysis set included all subjects exposed to trial product in this extension trial.|||Percentage of subjects|||Number
2735810|NCT00978380|Primary|Adverse Events (AEs)(Serious and Non-serious)|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.|All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit.|The FAS included the 60 unique subjects exposed to trial product in this extension trial.|||Events|||Number
2735811|NCT00978341|Secondary|Pharmacokinetic Evaluations of Pregabalin|Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.|Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose|||||||
2735812|NCT00978341|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.|FAS; Combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Inter-Quartile Range|Median
2735813|NCT00978341|Secondary|Mechanical Pain Sensitivity Stimulus-Response Function|Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).|Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose|FAS; combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
2735814|NCT00978341|Secondary|Punctate Allodynia Area|Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]).|Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose|FAS; combined results for At-level and Below-level spinal cord injury.|||cm2||Standard Deviation|Mean
2735815|NCT00978341|Secondary|Dynamic Allodynia Pain Score|Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.|Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose|FAS; Combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
2735816|NCT00978341|Secondary|Dynamic Allodynia Area|Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]).|Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,|FAS; Combined results for At-level and Below-level of spinal cord injury.|||cm2||Standard Deviation|Mean
2735817|NCT00978341|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)|FAS; Combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
2735818|NCT00978341|Primary|Present Pain Intensity Score|Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)|Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
2735831|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
2736733|NCT00974246|Primary|Pulmonary Function FEC/FVC Ratio at 16 Weeks|To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.|16 weeks||||ratio||Standard Deviation|Mean
2735819|NCT00978250|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0).|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 109 months and 16 days.|Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.|||Participants|||Count of Participants
2735820|NCT00978250|Primary|Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd)|Response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.|until subject progressed or went off study for other reasons (up to approximately 1 year)|All 93 patients eligible for the study were assessed for complete response (CR) or partial response (PR), including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug.|||percentage of participants||95% Confidence Interval|Number
2735821|NCT00978250|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.|until subject progressed or went off study for other reasons (up to approximately 1 year)|All 93 patients eligible for the study were assessed for PFS, including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug.|||months||95% Confidence Interval|Median
2735822|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
2735823|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
2735824|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
2735825|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroprotection: The percentage of participants with a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
2735826|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
2735827|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
2735828|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
2735829|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
2735830|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
2735832|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay(HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
2735833|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
2735834|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2|Percentage of participants with asthma exacerbations within 8 days after vaccination 2. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 21 to 28||||percentage of participants|||Number
2735835|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1|Percentage of participants with asthma exacerbations within 8 days after vaccination 1. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 1 to 8||||percentage of participants|||Number
2735836|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 2 by Dose Level Group.|Days 21 through 28||||percentage of participants|||Number
2735837|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 1 by Dose Level Group.|Days 1 through 8||||percentage of participants|||Number
2735838|NCT00978120|Primary|Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination|Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.|Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201||||percentage of participants|||Number
2735839|NCT00978068|Secondary|63-day Risk of Recurrent Malaria|To assess the effect of potential interactions between ART and artemether-lumefantrine, the risks of recurrent malaria at 63 days were compared between the two groups.|28 days after antimalarial therapy|The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether–lumefantrine.|||Cumulative Risk Percentage||95% Confidence Interval|Number
2735840|NCT00978068|Secondary|28-day Risk of Recurrent Parasitemia|To assess the effect of potential interactions between ART and artemether-lumefantrine, the risks of recurrent parasitemia at 28 days were compared between the two groups.|28 days after antimalarial therapy|The risk of recurrence was assessed among patients who had had uncomplicated malaria that had been treated with artemether–lumefantrine.|||Cummulative Risk Percentage||95% Confidence Interval|Number
2735841|NCT00978068|Secondary|Estimates of the 6-month Risk of a First Episode of Malaria|To assess the effect of ART independently of potential interactions with antimalarial therapy after treatment for malaria, we compared the two groups with respect to the time to the first episode of malaria. Cumulative risk was estimated using the Kaplan-Meier product-limit formula.|Enrollment to 6 months follow up|Among patients who were followed for 6 months, malaria did not develop in 34 patients in the NNRTI group and 44 in the lopinavir–ritonavir group; data on 10 patients in the NNRTI group and 7 in the lopinavir–ritonavir group were censored before the 6-month follow-up assessment.|||Cumulative Risk Percentage||95% Confidence Interval|Number
2735842|NCT00978068|Secondary|Incidence-density of Malaria Defined as the Number of Incident Episodes of Complicated Malaria Per Time at Risk.||Time from randomization to at least 24 months of follow up or until end of the study||||Episodes/ Person-Yr at Risk|||Number
2735843|NCT00978068|Secondary|Percentage of Uncomplicated Malaria Episodes With Accompanying Adverse Events That Occurred in the 28 Days Following Antimalarial Therapy|The rates of adverse events, defined as severity grade 2 or higher that are possibly, probably or definitely related to study drugs over the course of the 28-day period after antimalarial therapy with artemether-lumefantrine (AL).|28 days after antimalarial therapy||||% uncomplicated malaria episodes w/ AEs|||Number
2735844|NCT00978068|Primary|Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk.||Time from randomization to at least 24 months of follow up or until end of the study||||Episodes/ Person-Yr at Risk|||Number
2735845|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on MFVDS by Facial Region|"The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a responder, the average of the blinded, independent Evaluating Investigators' assessments of the participant's respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region."|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.|||percentage of responders|||Number
2735846|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)|"The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a responder, the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments."|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.|||Percentage of responders|||Number
2735847|NCT00978042|Secondary|Duration of Treatment Effect|Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators' assessments (with 95% Greenwood's Confidence Interval).|24 Months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to no treatment control arm who received treatment, with data available for analysis."|||Percentage of participants||95% Confidence Interval|Number
2735848|NCT00978042|Primary|Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)|"The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a responder, the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments."|6 months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to no treatment control arm, with data available for analysis."|||percentage of responders||95% Confidence Interval|Number
2735849|NCT00978029|Secondary|Proportion of Participants Who Discontinued Due to Adverse Events.|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 28|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
2735850|NCT00978029|Secondary|Proportion of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
2735851|NCT00978029|Secondary|Proportion of Participants Reporting Throat Irritation|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
2735852|NCT00978029|Secondary|Proportion of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
2735853|NCT00978029|Secondary|Proportion of Participants Reporting Oral Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
2735854|NCT00978029|Primary|The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 42|All subjects as treated (ASAT) consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
2735855|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).|||percentage of patients|||Number
2735856|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735857|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735858|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).|||percentage of patients|||Number
2735859|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735860|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735861|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).|||percentage of patients|||Number
2735862|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735863|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT||21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735864|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.|||percentage of patients|||Number
2735865|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.|||percentage of patients|||Number
2735866|NCT00977938|Primary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).|||percentage of patients|||Number
2735867|NCT00977938|Primary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735868|NCT00977938|Primary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
2735869|NCT00977808|Primary|Occurrence of Hypoglycemic Episodes|Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).|Overnight (21:30 until 08:00)|Only participants who completed both study periods were considered for this assessment.|||Hypoglycemic Episodes|||Number
2735870|NCT00977769|Secondary|Bleeding|The calculated estimated blood loss from delivery until 2 h after intervention|120 minutes||||ml blood loss||Standard Deviation|Mean
2735871|NCT00977769|Primary|Arterial Blood Pressure|The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 min||||percentage change in arterial blood pres||95% Confidence Interval|Mean
2735872|NCT00977769|Primary|Cardiac Output|The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 minutes||||percentage change in cardiac output||95% Confidence Interval|Mean
2735873|NCT00977704|Primary|Local and Systemic Adverse Events|"To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:~All local adverse events as reported by healthcare professional~All systemic adverse events (related and unrelated)"|2-weeks|Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.|||percentage of participants|||Number
2735874|NCT00977691|Primary|Patients With Donor Type Hemoglobin|Percentage of patients post transplant with sustained donor type hemoglobin on hemoglobin electrophoresis|1 year||||Participants|||Count of Participants
2735875|NCT00977665|Secondary|Total Number of Falls During the Study|Participants recorded each time they fell during the study in a diary.|Day 1 up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment, and who maintained diaries.|||falls||Inter-Quartile Range|Median
2735876|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)|The Beck Depression Inventory (BDI-II), is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Participants are asked to pick the answer for each question that best describes the way they have been feeling in the past two weeks, including the day participants complete the questionnaire. Each question is rated on a scale of 0-3, with 0 meaning the participant does not feel the emotion described in the question, and 3 meaning the participant has extremely strong feelings. Total scale is 0 (no evidence of depression) to 63 (extreme depression). Negative change from baseline scores indicate improvement in level of depression.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735877|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)|"UMSARS' questions are rated on a scale of 0=normal to 4=extreme impairment.~This endpoint reports the percentage of participants rated a 3 or worse. Rating 3 = Severely impaired speech (Question #1), swallowing (Question #2) or falling more frequently than once per week (Question #8)."|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||percentage of participants|||Number
2735878|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale|MoCA is a cognitive screening test which helps health professionals identify mild cognitive impairment. The total scale is 0 (significant cognitive impairment) to 30 (no impairment detected). Scores >=26 are considered normal. Positive change from baseline scores indicate improvement in cognition.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735879|NCT00977665|Secondary|Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications|"Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events:~An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study.~Dose modification of anti-parkinsonian or anti-orthostatic hypotension concomitant medications reflecting disease progression.~The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date.~Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible."|Day 0 (baseline) to Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||days||95% Confidence Interval|Median
2735880|NCT00977665|Secondary|Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect|This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.|Day 0 (baseline), Week 12|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2735881|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV|UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease).|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735882|NCT00977665|Secondary|Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment.~The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48."|Day 0 (baseline), Weeks 12-48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale/week||Standard Error|Mean
2735883|NCT00977665|Secondary|Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale|"The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= extreme problem."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735884|NCT00977665|Secondary|Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit|COMPASS_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse.|48 weeks|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735885|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation|UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally.|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||percentage of participants|||Number
2735886|NCT00977665|Secondary|Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.~In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 24|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735887|NCT00977665|Secondary|Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit|"Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse.~In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6."|Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2735888|NCT00977665|Primary|Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)|"This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.~In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment were included in the principal efficacy analysis, according to the treatment group to which they were originally assigned.|||units on a scale||Standard Error|Least Squares Mean
2735889|NCT00977613|Secondary|Overall Survival||after 6 months|||||||
2735890|NCT00977613|Secondary|Recurrence-free Survival||after 6 months|||||||
2735891|NCT00977613|Secondary|Disease-free Survival||after 6 months|||||||
2735892|NCT00977613|Primary|Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater|One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.|6 months|34 of the 50 enrolled subjects had at least 6 months of follow-up. There was no evaluable data for the remaining 16 subjects.|||participants|||Number
2735893|NCT00977574|Secondary|The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.|RECIST 1.1 was used to define objective tumor response. A complete response is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A partial response is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. There can be no unequivocal progression of non-target lesions and no new lesions. Complete and partial responses are included in the objective tumor response rate. Confirmation of response was not required.|Imaging was done every 3 cycles and at any other time clinically indicated. Imaging was required every 9 weeks until progression or initiation on non protocol therapy. After 2 years of protocol therapy or follow up, CT scan or MRI was every 3 months|Enrolled patients with measurable disease|||Participants|||Count of Participants
2735894|NCT00977574|Secondary|The Median Duration of Overall Survival for Each of the Three Arms.|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Time from date of study entry to time of death or the date of last contact, assessed up to 5 years|All enrolled patients|||months||95% Confidence Interval|Median
2735896|NCT00977574|Primary|Number of Participants Who Progressed or Died by 25 Months From Enrollment|PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574|at 25 months|All enrolled patients|||Participants|||Count of Participants
2735897|NCT00977561|Secondary|Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs|Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs|Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)|No analysis of total CTCs and IGF-IR-expressing CTCs was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735898|NCT00977561|Secondary|Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers||Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)|No analysis for serum circulating IGF pathway related markers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735899|NCT00977561|Secondary|Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway||Baseline prior to dosing|No analysis of tumor biomarkers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735900|NCT00977561|Secondary|Numeric Rating Scale (NRS) Score|"The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess worst pain severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for NRS score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735901|NCT00977561|Secondary|Cancer Dyspnea Scale (CDS) Score|"The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 Not at All to 5 Very Much)."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for cancer dyspnea scale score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735902|NCT00977561|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose|No analysis of ADA response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735903|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etoposide||Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of PK parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735904|NCT00977561|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of pharmacokinetics (PK) parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735905|NCT00977561|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmin for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735906|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmax for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2736199|NCT00976599|Primary|Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
2735907|NCT00977561|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.|Baseline up to follow-up (90 days post dose)|All randomized participants who received at least one dose of any agent of the combination were included in the safety analysis.|||participants|||Number
2735908|NCT00977561|Secondary|Overall Survival (OS)|Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].|Every 3 months until death or 12 months from the date the last participant was randomized|No analysis of overall survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735909|NCT00977561|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of objective response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735910|NCT00977561|Primary|Progression-Free Survival (PFS)|Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of progression-free survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
2735911|NCT00977548|Secondary|Leukemia Free Survival (LFS)|LFS: Survival without evidence of relapse at any time post-transplant. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||months||95% Confidence Interval|Median
2735912|NCT00977548|Secondary|Median Progression Free Survival (PFS)|PFS: The time elapsed between treatment initiation and tumor progression or death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis. Disease Progression is defined using International Working Group (IWG) Response Criteria for MDS, as at least 50% decrement from maximum remission/response levels in granulocytes or platelets; reduction in hemoglobin (Hgb) concentration by ≥ 2 g/dL; transfusion dependence.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||months||95% Confidence Interval|Median
2735913|NCT00977548|Secondary|Median Overall Survival (OS)|OS: The time from randomization until death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||months||95% Confidence Interval|Median
2735914|NCT00977548|Primary|Combined Overall Response Rate (ORR)|Best Response Categories: Marrow complete response (CR), Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment; Hematological improvement (HI), Hgb increase by ≥ 1.5 g/dL, Absolute increase of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L, At least 100% increase and an absolute increase of > 0.5 x 10^9/L, as defined by the International Working Group (IWG) 2006 criteria.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||participants|||Number
2735915|NCT00977470|Other Pre-specified|Percent of Participants in Which FMISO-PET ([18F]-Fluoromisonidazole-positron Emission Tomography) is Able to Detect and Quantify Changes in Tumor Hypoxia After Erlotinib.|[18F]-FMISO-PET/CT was performed on a 64-slice PET/CT scanner and tracer uptake was assessed using SUV (standardized uptake value), normalizing the radioactivity measured in tissue by the injected dose and the body weight of the patient. Mean and maximum SUV and threshold volume of FMISO uptake were measured to quantify the extent of hypoxia in the primary tumor. Imaging was performed before and after initiation of therapy with erlotinib.|12 weeks|Only 2 participants were enrolled in this pilot companion study|||Participants|||Count of Participants
2735916|NCT00977470|Other Pre-specified|EGFR Mutational Status|Correlation of molecular and genetic tumor characteristics with disease response. Genomic DNA will be extracted from tumor tissue and direct sequencing analysis will be performed to identify additional mutations.|2 years|Tumor tissue analysis was not performed for this correlative outcome.||||||
2735917|NCT00977470|Other Pre-specified|Circulating Tumor Cell Quantification|Serial circulating tumor cell (CTC) analyses will be performed on peripheral blood and correlated with disease response.|Until disease progression (median of 10.8 months)|Due to technical reasons, this assay was not ready and therefore circulating tumor cell analysis was not done.||||||
2735918|NCT00977470|Secondary|Overall Survival of Patients Treated With Erlotinib and With Erlotinib/HCQ||Until death||2019-12-31|12/2019||||
2739125|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day post drug administration 1||||score on a scale||Standard Error|Mean
2735919|NCT00977470|Secondary|Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.|"Response is assessed via spiral CT scan, done at baseline and after every 2 cycles of study treatment. Standard RECIST (Response Evaluation Criteria in Solid Tumors) was used. Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the size of target lesions, as compared to baseline; Progressive Disease (PD) = at least at 20% increase in the size of target lesions, or the appearance of one or more new lesions; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.~Response rate = CR + PR. Disease control rate = CR + PR + SD"|2 years|1 participant in each arm (2 participants total) did not have any scans done after baseline and therefore response could not be assessed.|||Participants|||Count of Participants
2735920|NCT00977470|Secondary|Treatment Related Toxicity, > 10% Frequency, Any Grade|To evaluate the safety of treatment with erlotinib with and without hydroxychloroquine (HCQ). All participants receiving study treatment were evaluated for safety. Parameters included laboratory tests, hematological abnormalities, physical exam findings and spontaneous reports of adverse events reported by participants. Toxicities were evaluated and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = fatal.|2 years||||Participants|||Count of Participants
2735921|NCT00977470|Primary|Nine-month Progression-free Survival Rate|This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus hydroxychloroquine (HCQ) arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test. Progression is defined as at least a 20% increase in the size of existing lesions or the appearance of one or more new lesions.|Nine months||||percentage of participants||95% Confidence Interval|Number
2735922|NCT00977470|Primary|Median Progression Free Survival|A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan.|From start of treatment until report of disease progression, assessed up to 10 years.||||months||Full Range|Median
2735923|NCT00977431|Secondary|Concentration of Afatinib in Plasma at Steady State Pre-dose on Days 8, 15 and 29|Concentration of afatinib in plasma at steady state pre-dose (Cpre,ss) on days 8, 15 and 29.|Pharmacokinetic blood sample were taken at 5 minutes before drug on days 8, 15 and 29 and 1, 3 and 6 hours after drug administration on day 15|Treated Set; only evaluable patients were included in the pharmacokinetic analysis|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2735924|NCT00977431|Secondary|The Objective Tumour Response According to the Macdonald Criteria|Objective response was defined as a best overall response of complete response (CR) or partial response (PR). The best overall response was the best overall response to trial medication according to the Macdonald criteria recorded since the first administration of trial medication and until the earliest of disease progression, death, or start of further anti-cancer treatment. Tumour response was assessed based on local radiological image evaluation by the investigators according to the Macdonald criteria: Complete Response (CR): Disappearance of all enhancing tumour on consecutive Magnetic resonance imaging (MRI) scans at least 28 days apart, off steroids, and neurologically stable or improved. Partial Response (PR): At least 50% reduction in size of enhancing tumour on consecutive MRI scans at least 28 days apart, steroids stable or reduced, and neurologically stable or improved.|From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks|Treated Set|||Participants|||Number
2735925|NCT00977431|Primary|Maximum Tolerated Dose (MTD) of Afatinib|The MTD was defined as the highest afatinib dose level, at which no more than 1 out of 6 patients experienced drug-related DLT, i.e. the highest afatinib dose with a DLT incidence ≤17%. A separate MTD was determined for afatinib and RT (Regimen U), and for afatinib, TMZ, and RT (Regimen M).|6 weeks|Treated Set (TS); 3 patients were not evaluable for the determination of the maximum tolerated dose replaced in regimen M. 7 patients were excluded from the Afatinib 40 mg arm regimen U count as these were part of the expansion phase after the Maximum Tolerated Dose (MTD) had been determined.|||Milligram (mg)|||Number
2735926|NCT00977431|Secondary|Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0)|Incidence and intensity of adverse events (AE) according to Common Terminology Criteria of Adverse Events (CTCAE v.3.0). The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks|Treated Set|||Participants|||Number
2735927|NCT00977431|Primary|Number of Patients With Investigator Defined Dose Limiting Toxicities (DLT) During the RT Phase|"Adverse event (AE) related to afatinib with any one criteria; Hematological: Common terminology criteria for adverse events (CTCAE) Grade 4 neutropenia (Absolute neutrophil count, including bands <500/cubic millimeter (mm³)) for >7 days, CTCAE Grade 3 or 4 neutropenia of any duration associated with fever >38.3 Celsius, CTCAE Grade 3 thrombocytopenia (platelet count <50000 - 25000/mm³), All other toxicities of CTCAE Grade ≥3 leading interruption of treatment > 14 days.~Non-hematological: CTCAE Grade ≥3 nausea or vomiting despite appropriate use of standard anti-emetics for ≥3 days, CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for ≥3 days, CTCAE Grade ≥3 rash despite standard medical management and lasting >7 days, CTCAE Grade ≥2 cardiac left ventricular function, CTCAE Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria or decrease in glomerular filtration rate, All other toxicities of CTCAE Grade ≥3."|6 weeks|Treated Set (TS); 3 patients were not evaluable for the determination of the maximum tolerated dose replaced in regimen M. 7 patients were excluded from the Afatinib 40 mg arm regimen U count as these were part of the expansion phase after the Maximum Tolerated Dose (MTD) had been determined.|||Participants|||Number
2736200|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
2735928|NCT00977379|Secondary|Absolute Change From Baseline in Mini Mental State (MMS) Total Score|MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state.|Baseline, Up to end of Treatment (up to 10.6 months overall)|ITT population. Here, number of participants analyzed = participants evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2735929|NCT00977379|Secondary|Overall Survival (OS)|OS was defined as the time from the start of study treatment to date of death due to any cause. OS was assessed using Kaplan-Meier analysis.|Baseline until death (up to approximately 1 year 5.5 months overall)|ITT population.|||months||95% Confidence Interval|Median
2735930|NCT00977379|Secondary|Time to Progression, Assessed by Investigator According to MRI and CT|Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial). PD was assessed by MRI or CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||months||Full Range|Median
2735931|NCT00977379|Secondary|Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT|Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions. PD was assessed by CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||months||Full Range|Median
2735932|NCT00977379|Secondary|Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT|Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"|ITT population.|||percentage of participants|||Number
2735933|NCT00977379|Secondary|Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)|Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||percentage of participants|||Number
2735934|NCT00977379|Secondary|Time to CNS Progression, Assessed by Investigator According to MRI|Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis. PD was assessed by contrast-enhanced MRI according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||months||Full Range|Median
2735935|NCT00977379|Secondary|Duration of CNS Response, Assessed by Investigator According to MRI|Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population. Here, number of participants analyzed = participants having had a CR or PR during the study.|||months||Full Range|Median
2735936|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"|ITT population.|||percentage of participants|||Number
2735946|NCT00977197|Secondary|Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|baseline, week 12|Intent to Treat analysis|||participants|||Number
2735937|NCT00977379|Secondary|Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI|Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||percentage of participants|||Number
2735938|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI in 3 Dimension|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by 3 dimensional MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"|The data for this outcome was not collected as per changes in planned analysis because sufficient information on the method used was not available.||||||
2735939|NCT00977379|Secondary|Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||percentage of participants|||Number
2735940|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)"|ITT population.|||percentage of participants|||Number
2735941|NCT00977379|Primary|Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|"Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|PP population included all ITT population participants excluding participants with following major protocol violations: inclusion and exclusion criteria not met; intake of prohibited treatment, protocol design and/or visit dates not respected; and missing values for main criterion without premature withdrawal.|||percentage of participants|||Number
2735942|NCT00977379|Primary|Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population|Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST). CR: disappearance of all CNS lesions. PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD.|"Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm WBRT Followed by Standard of Care only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)"|ITT population.|||percentage of participants|||Number
2735943|NCT00977314|Secondary|Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)|30 days||||Global Benefit Score||Standard Deviation|Mean
2735944|NCT00977314|Primary|Efficacy: Ability to Understand Speech in Noise|The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.|Day 1, Day 30||||dB||Standard Deviation|Mean
2735945|NCT00977314|Primary|Incidence of Device- and Procedure-related Adverse Events at 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination."|30 days||||participants|||Number
2735947|NCT00977197|Secondary|Mean Bloating BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735948|NCT00977197|Secondary|Mean Diarrhea BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735949|NCT00977197|Secondary|Mean Constipation BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735950|NCT00977197|Secondary|Mean Overall Severity BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735951|NCT00977197|Secondary|Mean Pain BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735952|NCT00977197|Secondary|Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy|"One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No."|Weeks 9-12|Intent to treat analysis|||participants|||Number
2735953|NCT00977197|Secondary|Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12)|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735954|NCT00977197|Secondary|Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735955|NCT00977197|Secondary|Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2735956|NCT00977197|Secondary|Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2736032|NCT00976989|Primary|Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period|Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period.|From baseline up to approximately 18 weeks|Safety population included all participants who were randomized and received study drug.|||percentage of participants|||Number
2735957|NCT00977197|Primary|Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|Intent to treat analysis|||units on a scale||Standard Deviation|Mean
2735958|NCT00977184|Secondary|Activities of Daily Living UPDRS|The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).|Baseline, 1 day post rTMS|Intent to treat|||units on a scale||Standard Deviation|Mean
2735959|NCT00977184|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.|Baseline, 1 day post rTMS|Intent to treat.|||units on a scale||Standard Deviation|Mean
2735960|NCT00977184|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|Baseline, 1 day post rTMS|Intent to treat|||units on a scale||Standard Deviation|Mean
2735961|NCT00977184|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|Baseline, 1 day post rTMS||||seconds||Standard Deviation|Mean
2735962|NCT00977184|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real rTMS and sham rTMS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline and 1 day post intervention.|Baseline, 1 day post rTMS|Intent to treat|||seconds||Standard Deviation|Mean
2735963|NCT00977171|Primary|Patient Global Impression of Improvement|The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.|Baseline to end of 12 week treatment period|3 patients enrolled in the study prior to it being stopped due to difficulty enrolling patients.|||units on a scale||Standard Deviation|Mean
2735964|NCT00977106|Secondary|DAS40 During the Open Treatment Period|DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2735965|NCT00977106|Secondary|Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period|DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
2735966|NCT00977106|Secondary|DAS28 During the Open Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2735967|NCT00977106|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
2736033|NCT00976989|Primary|Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator|Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.|From baseline up to approximately 3.5 years|Safety population included all participants who were randomized and received study drug.|||percentage of participants|||Number
2735968|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
2735969|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2735970|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||swollen joints||Standard Deviation|Mean
2735971|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints) . Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
2735972|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2735973|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||swollen joints||Standard Deviation|Mean
2735974|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
2735975|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.|Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2735976|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||tender joints||Standard Deviation|Mean
2735977|NCT00977106|Secondary|TJC Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
2735978|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2736034|NCT00976950|Secondary|Change in CD4+ Cell Count From Baseline at Week 48||48 weeks|Treated set with with non-missing data at the visit|||cells/mm^3||Standard Deviation|Mean
2743712|NCT00926497|Primary|Absolute Duration of Antibiotic Therapy|Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)|1 month||||hours||Full Range|Mean
2735979|NCT00977106|Secondary|Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||tender joints||Standard Deviation|Mean
2735980|NCT00977106|Secondary|Hemoglobin Concentration During the Open Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.|Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
2735981|NCT00977106|Secondary|Hemoglobin Concentration During the Double-Blind Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
2735982|NCT00977106|Secondary|FACIT-F During the Open Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2735983|NCT00977106|Secondary|Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Week 1 and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2735984|NCT00977106|Secondary|Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Day 0, Week 1, and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2735985|NCT00977106|Secondary|HAQ-DI During the Open Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
2735986|NCT00977106|Secondary|HAQ-DI During the Double-Blind Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Screening and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2735987|NCT00977106|Secondary|Weekly Methotrexate (MTX) Dose|Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week [mg/week] of oral or parenteral MTX). During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator's discretion.|Baseline and Weeks 24 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/week||Standard Deviation|Mean
2735988|NCT00977106|Secondary|Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period|S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L). Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||pmol/L||Standard Deviation|Mean
2743713|NCT00926497|Primary|Antibiotic Treatment for More Than 72 Hours|Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)|1 month||||participants|||Number
2735989|NCT00977106|Secondary|Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period|S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism. Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||ng/mL||Standard Deviation|Mean
2735990|NCT00977106|Secondary|S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period|S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL). Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline, Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||pg/mL||Standard Deviation|Mean
2735991|NCT00977106|Secondary|Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period||Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2735992|NCT00977106|Secondary|Bone Mineral Density|To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used. All DXA at baseline were taken into account (done from before screening to Week 8). DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab. Values were measured in milligrams per square centimeter (mg/cm^2).|Baseline and Week 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/cm^2||Standard Deviation|Mean
2735993|NCT00977106|Secondary|Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation. If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2735994|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mg/L||Standard Deviation|Mean
2735995|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Open Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population;n=number of participants assessed for the specified parameter at a given visit.|||mcg/mL||Standard Deviation|Mean
2735996|NCT00977106|Secondary|Serum Amyloid A Component During the Open Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
2735997|NCT00977106|Secondary|Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation. A negative change from baseline indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2735998|NCT00977106|Secondary|Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L. A reduction in SAA indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mg/L||Standard Deviation|Mean
2735999|NCT00977106|Secondary|C- Reactive Protein During the Open Treatment Period|C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||ng/L||Standard Deviation|Mean
2736000|NCT00977106|Secondary|Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation. Negative changes from baseline indicate improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2736001|NCT00977106|Secondary|C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). A reduction in CRP indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||ng/mL||Standard Deviation|Mean
2736035|NCT00976950|Secondary|Virologic Response|Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.|48 weeks|Treated set (TS), defined as patients treated with Aptivus|||Number of participants|||Number
2736002|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Open Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr. A reduction in ESR indicates improvement. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2736003|NCT00977106|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment|Erythrocyte sedimentation rate is a biological marker of inflammation. A negative change indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2736004|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr). A reduction in ESR indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm/hr||Standard Deviation|Mean
2736005|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound|"Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from 0 to 3, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline."|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2736006|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound|"Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from 0 to 3, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline."|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
2736007|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound|"Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from 0 to 3, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement."|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
2736008|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound|"Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from 0 to 3, for each of 40 joints (5 metacarpal phalangeal [MCP; left and right] joints, 5 proximal interphalangeal [PIP; left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal [MTP; left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120. A score of 0 indicated no damage and a score of 120 indicated most severe damage. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement."|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
2736009|NCT00977106|Secondary|Patient Global Assessment of Pain During the Open Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed at a specific visit|||mm||Standard Deviation|Mean
2736010|NCT00977106|Secondary|Patient Global Assessment of Pain During the Double-Blind Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
2736011|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Open Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
2736012|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
2736013|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Open Treatment Period|Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36 and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
2736014|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period|Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 1 and 4|ITT Population; number (n) = number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
2736015|NCT00977106|Primary|Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.|Week 4|ITT Population|||percentage of participants|||Number
2736016|NCT00977080|Secondary|Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
2736017|NCT00977080|Secondary|Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
2736018|NCT00977080|Secondary|Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
2736019|NCT00977080|Secondary|Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
2736020|NCT00977080|Secondary|Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
2736036|NCT00976950|Primary|Number of Patients Reporting Adverse Events (AE)|Any type of adverse events|48 weeks|Treated set (TS), defined as patients treated with Aptivus|||Participants|||Number
2749879|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
2736021|NCT00977080|Primary|The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
2736022|NCT00976989|Secondary|Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures|Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.|From baseline up to approximately 3.5 years|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable.|||percentage (ejection fraction)||Standard Deviation|Mean
2736023|NCT00976989|Secondary|Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events|Percentage of participants with LVEF events without signs or symptoms of cardiac events.|From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.|||percentage of participants|||Number
2736024|NCT00976989|Secondary|Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)|Percentage of participants with signs or symptoms of cardiac events.|From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.|||percentage of participants|||Number
2736025|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event|Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.|||percentage of participants|||Number
2736026|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event|The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.|||percentage of participants|||Number
2736027|NCT00976989|Secondary|Efficacy: Percentage of Participants Without an Overall Survival (OS) Event|Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.|||percentage of participants|||Number
2736028|NCT00976989|Secondary|Efficacy: Percentage of Participants Achieving Breast Conserving Surgery|This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.|At approximately 18 weeks|Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.|||percentage of participants|||Number
2736029|NCT00976989|Secondary|Efficacy: Time to Clinical Response|Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks|ITT population included all participants who were randomized to treatment.|||weeks||95% Confidence Interval|Median
2736030|NCT00976989|Secondary|Efficacy: Clinical Response Rate|Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|During each 3-week cycle of 6 total cycles: up to 18 weeks|ITT population included all participants who were randomized to treatment.|||percentage of participants|||Number
2736031|NCT00976989|Secondary|Efficacy: Percentage of Participants With Complete Pathological Response (pCR)|pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.|At surgery, after 18 weeks (6 cycles) of treatment|Intent to treat (ITT) population included all participants who were randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
2739126|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day prior to drug administration 1||||score on a scale||Standard Error|Mean
2736037|NCT00976937|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2736038|NCT00976937|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ratio||Standard Error|Least Squares Mean
2736039|NCT00976937|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2736040|NCT00976937|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2736041|NCT00976937|Other Pre-specified|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2736042|NCT00976937|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2736043|NCT00976937|Secondary|Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment-Beta (HOMA-beta) at Week 24|HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||percentage of normal beta cells function||Standard Error|Least Squares Mean
2736044|NCT00976937|Secondary|Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24|HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-IR assessment during on-treatment period.|||mU * mmol/L^2||Standard Error|Least Squares Mean
2736045|NCT00976937|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
2736046|NCT00976937|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ng/L||Standard Error|Least Squares Mean
2736047|NCT00976937|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||nmol/L||Standard Error|Least Squares Mean
2736048|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
2736049|NCT00976937|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2736050|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2736051|NCT00976937|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2736052|NCT00976937|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2736053|NCT00976937|Secondary|Absolute Change From Baseline in HbA1c at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2736054|NCT00976937|Primary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24|Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population included randomized patients who received at least 1 dose of study drug. Missing data was imputed using Last observation carried forward (LOCF).|||percentage of participants|||Number
2736055|NCT00976911|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)|The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.|Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)|ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.|||percentage of participants||95% Confidence Interval|Number
2736414|NCT00975585|Primary|Overall Comfort|After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks and 4 weeks|Analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2736056|NCT00976911|Secondary|Overall Survival (Data Cutoff 25 January 2013)|Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
2736057|NCT00976911|Primary|Progression Free Survival (PFS; Data Cutoff 14 November 2011)|PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with an event of progression or death were included in the analysis|||months||95% Confidence Interval|Median
2736058|NCT00976911|Secondary|Percentage of Participants Who Died (Data Cutoff 25 January 2013)||Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population|||percentage of participants|||Number
2736059|NCT00976911|Secondary|Duration of Objective Response (Data Cutoff 14 November 2011)|For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan−Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with a best overall confirmed response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2736060|NCT00976911|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2736061|NCT00976911|Primary|Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)|Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomization|||percentage of participants|||Number
2736062|NCT00976898|Secondary|Patterns of Failure|A summary of the patterns of treatment failure, shown as the number of participants that fall into each category at the end of study follow-up|2 years||||Participants|||Count of Participants
2736063|NCT00976898|Secondary|Number of Participants With Treatment Related Adverse Events ≥ Grade 3|Summary of the proton radiation related grade 3 or greater adverse events that participants experienced. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v3).|2 years||||Participants|||Count of Participants
2736064|NCT00976898|Primary|Median Overall Survival|The median survival time in months as measured from the start of treatment until death due to any cause or until the participants is censored. Participants are censored at the date of their last follow-up.|5 years||||Months||95% Confidence Interval|Median
2736065|NCT00976898|Primary|2 Year Local Control Rate|The percentage of participants with local control after two years as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The duration of control was measured from the start of treatment. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesion(s).|2 years||||percentage of participants||95% Confidence Interval|Number
2736415|NCT00975585|Primary|Overall Comfort|After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2736066|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736067|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 182 days (Days 0-181) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736068|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 42 days (Day 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736069|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - First Analysis|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736070|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736071|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736072|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 182 days (Days 0-181) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736073|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736074|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736075|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736076|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736077|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 182 days (Days 0-181) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736078|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736919|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alanine Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736079|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 41 days (Days 0-40) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736080|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736081|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 84 days (Days 0-83) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736082|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 41 days (Days 0-40) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736083|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736084|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736085|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 182|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736086|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 182|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736087|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7, at Day 21 and at Day 42|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736088|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7 and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736922|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736089|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7, at Day 21 and at Day 42|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736090|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities - First Analysis|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7, at Day 21 and at Day 42|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736091|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7 and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736092|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7 and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736093|NCT00976820|Secondary|Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736094|NCT00976820|Secondary|Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736095|NCT00976820|Secondary|Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736096|NCT00976820|Secondary|Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736097|NCT00976820|Secondary|Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736201|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
2736098|NCT00976820|Secondary|Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736099|NCT00976820|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736100|NCT00976820|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736101|NCT00976820|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736102|NCT00976820|Secondary|Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations|Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736103|NCT00976820|Secondary|Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations|Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736104|NCT00976820|Secondary|Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736105|NCT00976820|Secondary|Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736106|NCT00976820|Secondary|Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736107|NCT00976820|Secondary|Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736108|NCT00976820|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
2736181|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736109|NCT00976820|Secondary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0 (PRE) and at Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736110|NCT00976820|Secondary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736111|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736112|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736113|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736114|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736115|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2736116|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2736117|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736118|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - Second Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736119|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - First Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736120|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - Second Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736182|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736121|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - First Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736122|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736123|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
2736124|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
2736125|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
2736126|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
2736127|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2736128|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736129|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736130|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736131|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736132|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736183|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736133|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736134|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736135|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736136|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 21|The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736137|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736138|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736139|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736140|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736141|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2736142|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
2736143|NCT00976716|Secondary|Summary of Adverse Events|The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|8 days|The safety analysis set consisted of all patients who had taken at least one study medication.|||Participants|||Number
2736144|NCT00976716|Secondary|Withdrawal Due to Lack of Efficacy|The number of subjects who withdrew due to insufficient clinical response was evaluated.|8 days|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.|||Participants|||Number
2736145|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose|"The investigator assessed the localized warmth, using the categories None, Mild, Moderate, and Severe at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit."|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||Participants|||Number
2736146|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose|"The investigator assessed the redness, using the categories None, Mild, Moderate, and Severe at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit."|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||Participants|||Number
2736147|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose|"The investigator assessed the swelling, using the categories None, Mild, Moderate, and Severe at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit."|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||Participants|||Number
2736148|NCT00976716|Secondary|Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.|Two, 4 and 6 hours post first dose|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.|||mm||95% Confidence Interval|Mean
2736149|NCT00976716|Secondary|Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose|6 hours|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.|||mm||95% Confidence Interval|Mean
2736150|NCT00976716|Secondary|PID in Pain on Active Movement Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
2736151|NCT00976716|Secondary|Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
2736152|NCT00976716|Secondary|PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose|The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
2736153|NCT00976716|Secondary|Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose|The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
2736154|NCT00976716|Secondary|"Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated Excellent and Good)"|"The patient impression of the study medication was entered in the patient diary based on the following categories: excellent, good, fair and poor.~Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until each time point."|6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.|||Participants|||Number
2736167|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
2736155|NCT00976716|Primary|"Patient Impressions at Final Visit (the Number of Participants Who Have Rated Excellent and Good)"|"The patient impression of the study medication was entered in the patient diary based on the following categories: excellent, good, fair and poor.~Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until Final Visit."|8 days|The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.|||Participants|||Number
2736156|NCT00976703|Other Pre-specified|Maternal Morbidities|post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT|30 days after delivery||||diagnoses|||Number
2736157|NCT00976703|Secondary|Time to Foley Expulsion|time from Foley placement until it is spontaneously expulsed from the cervix|an average of 2 hours, up to 12 hours||||hours||Full Range|Median
2736158|NCT00976703|Secondary|Patient Pain/Comfort Rating|Using a visual analog pain scale, with 0 being no pain and 10 being the most severe pain possible, the patients were asked to assess their pain every hour. The highest pain score recorded while the Foley catheter was in place was used. The data are reported as the median and range.|an average of 20 hours, up to 40 hours|All patients had pain scores recorded and used in analysis. The values in the table represented the recorded data available and used in the analysis.|||units on a scale||Full Range|Median
2736159|NCT00976703|Primary|Time to Delivery||an average of 20 hours, up to 40 hours|In order to find a 20% difference with a 40% standard deviation, power of 90%, and alpha of 0.05, we estimated we needed 86 patients in each arm. We aimed to recruit 194 patients to account for potential dropouts and missing data.|||hours||Standard Deviation|Mean
2736160|NCT00976677|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years|All eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
2736161|NCT00976664|Primary|Oswestry Disability Index (ODI)|This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.|||units on a scale||Standard Deviation|Mean
2736162|NCT00976664|Primary|Visual Analog Scale (VAS)|This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.|||units on a scale||Standard Deviation|Mean
2736163|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
2736164|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
2736165|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
2736166|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
2736197|NCT00976599|Primary|Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.||||||
2736168|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
2736169|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in TJC; >= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
2736170|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in TJC; >= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
2736171|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
2736172|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
2736173|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
2736174|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mmol Cr||Standard Deviation|Mean
2736175|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
2736176|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as nanogram per millimoles of creatinine (ng/mmol Cr).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
2736177|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736178|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736179|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||pg/mL||Standard Deviation|Mean
2736180|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||pg/mL||Standard Deviation|Mean
2756303|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2736184|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736185|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736186|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736187|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736188|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736189|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||ng/mL||Standard Deviation|Mean
2736190|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736191|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736192|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736193|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736194|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736195|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736196|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1|Serum samples were analyzed for SAA concentrations using meso scale discovery (MSD) single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific Electro ChemiLuminescent ImmunoAssay (ECLIA).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||ng/mL||Standard Deviation|Mean
2736202|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
2736203|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
2736204|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
2736205|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 10|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
2736206|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2736207|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
2736208|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2736209|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736210|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736211|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736212|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736213|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736214|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736215|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 10|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736216|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736217|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736218|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2739127|NCT00957359|Primary|STAI Trait|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2736219|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736220|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736221|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736222|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2736223|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736224|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736225|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736226|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736227|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
2736228|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific Enzyme-Linked Immunosorbent Assay [ELISA] method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2736229|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736230|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736320|NCT00976339|Primary|Number of Participants That Successfully Completed the 1-year Intervention||1 year|Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.||||||
2736231|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736232|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736233|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736234|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736235|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736236|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736237|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2736238|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1|Blood samples were collected for fluorescence-activated cell sorting [FACS] analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, Bone-marrow cells (B cells) and natural killer (NK) cells were analyzed using fluorescent-labeled antibodies against clusters of differentiation (CD) markers.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
2736239|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 35 or Early Termination|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736240|NCT00976599|Primary|Blood Cytokine Level at 24 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736241|NCT00976599|Primary|Blood Cytokine Level at 8 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736242|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736321|NCT00976274|Secondary|Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)||baseline and 12 weeks||||uIU/mL||Standard Deviation|Mean
2736322|NCT00976274|Primary|Change in the Pre- and Post-treatment Systolic Blood Pressure||baseline and 12 weeks||||mm Hg||Standard Deviation|Mean
2736243|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736244|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736245|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 10|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736246|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 hours post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
2736247|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 hour post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736248|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, active 70 kDa (p70) form of IL-12(IL-12p70), interferon gamma (IFNgamma) - induced protein 10 (IP-10), TNFalpha, granulocyte macrophage colony-stimulating factor (GM-CSF), macrophage inflammatory protein 1 alpha (MIP1a), monocyte chemotactic protein 1 (MCP1), soluble vascular endothelial growth factor (sVEGF), soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), granulocyte colony-stimulating factor (G-CSF) was measured by immunoassay and the levels were expresses as picogram per milliliter (pg/mL).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
2736249|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3E, STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||REU||Standard Deviation|Mean
2736250|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3 epsilon (CD3E), STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Baseline (Day -7)|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||REU||Standard Deviation|Mean
2736251|NCT00976599|Primary|Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28|The intensity of CD3 and CD68 cell infiltration was expressed as the percentage area of the tissue section occupied by positively stained cells. Surface marker CD68 macrophages and CD3 thymus cells (T cells) in the inflammatory cells of synovial tissue were detected by immunohistochemical staining.|Baseline (Day -7), Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage area stained||Standard Deviation|Mean
2736252|NCT00976599|Primary|Change From Baseline in Protein Expression of Tumor Necrosis Factor Alpha (TNFalpha), Interleukin-6 (IL-6), Interleukin-17a (IL-17a) and Interleukin-10 (IL-10) at Day 28|Synovial tissue biopsy was to be performed and assayed for protein expression by quantitative PCR using standard curve method. Standard curve was to be generated by linear regression using log threshold cycle versus log (cell number). TNFalpha, IL-6, IL-17 and IL-10 data were to be presented as control normalized expression (relative expression) within synovial tissue.|Baseline (Day -7), Day 28|Analyses of TNFalpha, IL-6, IL-17 and IL-10 were not performed due to insufficient samples and lack of appropriate method to process/analyze the samples.||||||
2736323|NCT00976248|Primary|Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM||End of follow-up, an average of 18 months|13 participants were censored due to follow-up ending prior to new therapy initiation.|||Months||Full Range|Median
2736253|NCT00976599|Primary|Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28|Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.|Day -7 (Baseline), Day 28|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study medication. Analyses of tumor necrosis factor alpha(TNFα), receptor activator of nuclear factor kappa-B ligand(RANKL), osteoprotegerin(OPG) were not performed due to insufficient samples and lack of appropriate method to process/analyze samples.|||relative expression unit (REU)||Standard Deviation|Mean
2736254|NCT00976573|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival times will be estimated using the method of Kaplan-Meier.|up to 5 years|Intent-to-treat analysis population: All participants enrolled are included.|||months||95% Confidence Interval|Median
2736255|NCT00976573|Secondary|Confirmed Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Confirmed Tumor Response: A confirmed tumor response is defined to be a CR or PR (by the RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The proportion of tumor responses will be estimated by the number of confirmed tumor responses divided by the total number of evaluable patients. A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.|Up to 5 years|Intent-to-treat analysis population: All participants enrolled are included.|||percentage of patients||95% Confidence Interval|Number
2736256|NCT00976573|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The percentage of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 5 years|Participants who completed the study (specified in the Participant Flow) are included.|||percentage of participants|||Number
2736257|NCT00976573|Primary|Progression-free Survival|The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of disease progression or death without documentation of progression. The distribution of PFS times will be estimated using the Kaplan-Meier method. Progression is defined using the RECIST Criteria as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum of diameters recorded on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm of target lesions, or the appearance of one or more new lesions, unequivocal progression of existing non-target lesions, although unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Time from randomization to documentation of disease progression or death without documentation of progression;Up to 5 years|Intent-to-treat analysis population: All participants enrolled are included in the primary analysis.|||months||95% Confidence Interval|Median
2736258|NCT00976560|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) up to 6 Weeks|"CGI-S assesses the severity of the participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). The number of participants with a CGI-I score of either 1 (very much improved) or 2 (much improved) were grouped together for each timepoint. Participants with no missing CGI-S scores were categorised as having a CGI-S score of ≤ 2 or > 2. The total score was calculated for each participant at each timepoint and percentage was calculated."|Upto Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736259|NCT00976560|Secondary|"Percentage of Participants With a Clinicians Global Impression of Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 3, 4, 5 and 6."|"The number of participantts with a CGI-I score of either 1 (very much improved) or 2 (much improved) were grouped together for each timepoint. Participants with no missing CGI-I scores were categorised as having a CGI-I score of ≤ 2 or > 2."|Weeks 1, 2, 3, 4, 5 and 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736260|NCT00976560|Secondary|Percentage of Bech Remitters (Participants Whose Total Score Was ≤ 4 at Week 6/Study Exit).|The Bech scale was extracted from the HAMD-17 and comprised of 6 items out of which 5 were 5 point questions and 1 was 3 point question. The Bech Total Score was calculated by summing the individual response scores. Due to the small number of items, missing data was not imputed for the Bech Total Score. If any of the 6 items were missing, the total score was not calculated at that visit. The change from randomization was analysed using suitable BMMRM assuming missing at random MAR. The BECH total score was calculated for each subject at each timepoint and those perticipants with no missing value for BECH total score were categorised as having a BECH total score of ≤ 4 or > 4.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736324|NCT00976248|Primary|Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM.|Progression is defined as a 25% increase in serum IgM from the lowest attained response value or progression of clinically significant disease related symptoms.|End of Treatment, an average of 16 months|13 participants were excluded from this analysis due to treatment and follow-up ending prior to progression.|||Months||Full Range|Median
2739128|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2736261|NCT00976560|Secondary|Percentage of Bech Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).|The Bech scale was extracted from the HAMD-17 and comprised of 6 items out of which 5 were 5 point questions and 1 was 3 point question. The Bech Total Score was calculated by summing the individual response scores. Due to the small number of items, missing data was not imputed for the Bech Total Score. If any of the 6 items were missing, the total score was not calculated at that visit. A responder is a participant who has a ≥50% reduction from randomisation in the total score for that given endpoint. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%. The change from randomization was analysed using suitable BMMRM assuming missing at random.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736262|NCT00976560|Secondary|Percentage of QIDS-SR16 Remitters (Subjects Whose Total Score Was ≤ 5 at Week 6/Study Exit).|QIDS-SR assesses symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It contains 16 separate items (corresponding to 16 items of the much longer IDS-SR), defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The QIDS-SR total score was calculated by summing over the domain scores. The highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. The QIDS total score was calculated for each subject at each timepoint and those subjects with no missing value for QIDS total score was categorised as having a QIDS total score of ≤ 5 or > 5. Participants whose total score was ≤ 5 were included here.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736263|NCT00976560|Secondary|Percentage of QIDS-SR16 Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).|QIDS-SR assesses symptoms severity of DSM-IV diagnostic criterion for major depressive disorder. It contains 16 separate items (corresponding to 16 items of the much longer IDS-SR), defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain.The highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. A responder is a participant who has a ≥50% reduction from randomisation in the total score for that given endpoint. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of Participants|||Number
2736264|NCT00976560|Secondary|Percentage of IDS-SR Remitters (Participants Whose Total Score Was ≤ 15 at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. IDS-SR total score was calculated for each participant at each timepoint and those participants with non-missing values for IDS-SR total scores were categorised as having an IDS-C for the respective endpoint of ≤ 15 or > 15. Participants whose total score was ≤ 15 were included here.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736265|NCT00976560|Secondary|Percentage of IDS-SR Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. A responder is a participant who has a ≥50% reduction from randomisation in the total score for IDS-SR. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%. The change from randomization was analysed using suitable BMMRM assuming missing at random.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
2736266|NCT00976560|Secondary|Percentage of IDS-C Remitters (Participants Whose Total Score Was ≤ 15 at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. IDS-C total score was calculated for each participant at each timepoint and those participants with non-missing values for IDS-C total scores were categorised as having an IDS-C for the respective endpoint of ≤ 15 or > 15. Participants whose total score was ≤ 15 were included here.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2736267|NCT00976560|Secondary|Percentage of IDS-C Responders (Participants With a Reduction in Total Score of ≥50% From Randomization at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. A responder is a participant who has a ≥50% reduction from randomisation in the total score for IDS-C. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%. The change from randomization was analysed using suitable Bayesian mixed-effects model repeated measures (BMMRM) assuming missing at random (MAR).|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of Participants|||Number
2736268|NCT00976560|Secondary|Mean Quick Inventory of Depressive Symptomatology Self Report-16 Item (QIDS-SR16) Total Score Derived From the IDS-SR (Only at Weeks 0, 2, 4 and 6)|QIDS-SR assesses symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It contains 16 separate items (corresponding to 16 items of the much longer IDS-SR), defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The QIDS-SR total score was calculated by summing over the domain scores. The highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score.|Weeks 0, 2, 4 and 6|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
2736269|NCT00976560|Secondary|Mean IDS-SR Total Score|The 30 item IDS is available in two versions IDS-SR and IDS-C. To calculate the total score of IDS, 28 out of the 30 items were scored. Either weight loss or weight gain, appetite loss or appetite gain is scored because only one member of each pair is applicable to any given respondent. The standard total score is obtained by summing the ratings of 28 of the 30 items. Each of the 28 items is scored on a 0 to 3 scale (0 - the absence of pathology; 3 - severe pathology). The total scores range from 0 to 84. If more than one response was missing then the score was calculated using the formula Observed Total Score*[1+(Sum of the Maximum Score of the missing values/Sum of the Maximum Score of the non -missing values)].|Up to Week 6|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
2736270|NCT00976560|Secondary|Mean Inventory of Depressive Symptomatology Clinician (IDS-C) Total Score|The 30 item IDS is available in two versions IDS-C and Inventory of Depressive Symptomatology self-rated (IDS-SR). To calculate the total score of IDS, 28 out of the 30 items were scored. Either weight loss or weight gain, appetite loss or appetite gain is scored because only one member of each pair is applicable to any given respondent. The standard total score is obtained by summing the ratings of 28 of the 30 items. Each of the 28 items is scored on a 0 to 3 scale (0 - the absence of pathology; 3 - severe pathology). The total scores range from 0 to 84. If more than one response was missing then the score was calculated using the formula Observed Total Score*[1+(Sum of the Maximum Score of the missing values/Sum of the Maximum Score of the non -missing values)].|Up to Follow-up visit (Day 53)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
2736271|NCT00976560|Secondary|Mean HAMD-17 Total Score|HAMD-17 is Hamilton Depression Rating Scale which has 17 questions. The HAMD-17 Total Score was calculated by summing the individual response scores over the 17 individual components of the interview. The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. If not more than 1 response was missing, the total score was caculated as Observed Total Score * [1 + (Sum of the Maximum Score of the missing values/Sum of the Maximum Score of the non -missing values)]. There were 9 five point questions and 8 three point questions. The responses to the individual questions can have values of 0-2 (three points response) or 0-4 (five points response).|Up to Follow-up visit (Day 53)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
2736272|NCT00976560|Secondary|Change From Randomisation Bech Total Score: Bech Score|HAMD-17 has 17 questions. The BECH scale was extracted from the HAMD-17 and comprises of 6 items out of which 5 are 5 point questions and 1 is 3 point question. The Bech scale was extracted from the HAMD-17 and comprised of 6 items out of which 5 were 5 point questions and 1 was 3 point question. The Bech Total Score was calculated by summing the individual response scores and ranged from 0 to 22, with higher scores indicating more severe depression. Due to the small number of items, missing data was not imputed for the Bech Total Score. If any of the 6 items were missing, the total score was not calculated at that visit. The change from randomization was analysed using suitable Bayesian Mixed-Effects Models for Repeated Measures (BMMRM) assuming missing at random MAR.|Up to Follow-up visit (Day 53)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2736273|NCT00976560|Secondary|Changes From Randomization (Week 0)in IL-6 and TNF-alpha Associated With GW856553 Versus Placebo at Week 1 and Week 6 in the Morning Plasma Levels|Interlukin-6 (IL-6) and Tumor Necrosis Factor-Alpha (TNF-alpha) from the participants with Major Depressive Disorder (MDD) were evaluated and analyzed using suitable mixed-effects model repeated measures (MMRM). Exploratory analysis on plasma levels of IL-6 and TNF-alpha were performed. Week 0 values were considered as Baseline.The change from Baseline was calculated by subtracting the baseline values from the individual post-randomisation values.|Upto Week 6|"Intent-to-Treat (ITT) Population - It consists of all randomised subjects who receive at least one dose of study medication and had at least one post-dose efficacy assessment.~Only those participants with data available at the indicated time points were analyzed."|||picogram/mililitre (pg/mL)||Standard Deviation|Mean
2736274|NCT00976560|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|ECG was obtained at Week 2 and Week 6. ECG was recorded using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and Corrected QT (QTc) intervals (Bazett's correction was applied to QTc measurements). Number of participants with abnormal ECG readings are summarized.|Up to follow-up Visit (Day 53)|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2736275|NCT00976560|Secondary|Number of Participants With Abnormal Vital Signs (Blood Pressure, Heart Rate)|Vital signs including systolic and diastolic blood pressure and heart rate were taken from day 1 upto follow-up visit. Number of participants with abnormal systolic blood pressure, diastolic blood pressure and heart rate values were summarized.|Up to follow-up Visit (Day 53)|All Subjects Population. Only those participants with data available at the indicated time points were analyzed|||Participants|||Count of Participants
2736337|NCT00975923|Secondary|Access of Tools and Use of Quality Improvement Strategies|Follow-up survey of ICU nurse and quality managers for all participating medical centers from Jan 2008 through April 2008 included questions about the implementation of process interventions: Access and use of clinical guidelines tools, access and use of quality improvement tools, and types of quality improvement implementation strategies.|18 months|per protocol|||Percentage of ICUs|||Number
2736276|NCT00976560|Secondary|Number of Participants With Abnormal Haematology and Clinical Chemistry Values|Samples for haematology and clinical chemistry were collected on Weeks 1, 5 and 6. The analyzed haematological parameters were platelet count, red blood cells count, white blood cells count, reticulocyte count, hemoglobin and hematocrit. The analyzed clinical chemistry parameters were urea, creatinine, glucose (fasting), sodium, lactate dehydrogenase (LDH), potassium, chloride, calcium, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, creatine kinase (CK), total and direct bilirubin, albumin, total protein and total cholesterol. Number of participants with any abnormal haematological or clinical chemistry parametrs are summarized here.|Upto Week 6|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2736277|NCT00976560|Secondary|Number of Participants With Suicidality as Assessed by the Columbia Suicidality Severity Rating Scale Score|"Suicidility was defined as participants with major depressive disorder who experienced worsening of their depression and/or the emergence of suicidal ideation and behavior. Number of partcipants who experienced suicidality were reported. On the Suicidal Ideation scale of the Columbia Suicide-Severity Rating Scale (C-SSRS) participants were scored as non-suicidal (00), wish to be dead (01), non-specific active suicidal thoughts (02), active suicidal ideation with associated thoughts of methods without intent (03), active suicidal ideation with some intent to act on suicidal thoughts without clear plan (04) and active suicidal ideation with plan and intent (05), based on the most severe score (5 being the most severe).Suicidal ideation of type 4 or 5 in the C-SSRS was categorized as suicidility here."|Upto Week 6|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2736278|NCT00976560|Secondary|Number of Participants With Adverse Events|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. The AEs row include participants with SAEs.|6 Weeks|All Subjects Population - It comprised of all participants who receive at least one dose of study medication.|||Participants|||Count of Participants
2736279|NCT00976560|Primary|Change From Randomization (Week 0) Associated With GW856553 Versus Placebo at Week 6 in the Bech (6-item HAMD-17 [Hamilton Depression Rating Scale]) Score.|HAMD-17 has 17 questions. The HAMD-17 Total Score was calculated by summing the individual response scores over the 17 individual components of the interview. The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. There were 9 five point questions and 8 three point questions. The responses to the individual questions had values of 0-2 (three points response) or 0-4 (five points response). The BECH scale was extracted from the HAMD-17 and comprises of 6 items out of which 5 are 5 point questions and 1 is 3 point question. The Bech Total Score was calculated by summing the individual response scores and ranged from 0 to 22, with higher scores indicating more severe depression. Week 0 values were considered as Baseline.The change from randomization was analysed using suitable Bayesian mixed-effects model repeated measures (BMMRM) assuming missing at random (MAR).|At Week 6|"Intent-to-Treat (ITT) - It comprised of all randomised participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.~Only those participants with data available at the indicated time points were analyzed."|||Scores on scale||Standard Deviation|Mean
2736280|NCT00976521|Secondary|Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration|The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.|30 Days|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total myocardial mass were available for 192 and 190 patients randomized to thrombus aspiration versus no no thrombus aspiration, respectively for the ITT (intention to treat) analysis set.|||Percentage of Total Myocardial Mass||Inter-Quartile Range|Median
2736281|NCT00976521|Primary|Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion|The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.|30 Days Post Index Procedure|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total left ventricular mass were available for 181 and 172 patients randomized to intracoronary abciximab infusion versus no abciximab infusion, respectively for the ITT (intention to treat) analysis set.|||Percentage of Left Ventricular Mass||Inter-Quartile Range|Median
2736282|NCT00976508|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)|Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment.|||participants|||Number
2736283|NCT00976508|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing ADA for figitumumab.|Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736923|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Bilirubin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736284|NCT00976508|Secondary|Mean Change in Glucose Levels Between Fasting and Post Glucose Load|The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.|Screening; Day 8 of Cycle 1; Day 15 of Cycle 2|Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2736285|NCT00976508|Secondary|Area Under the Trough Concentrations (AUCtrough)|The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.|Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736286|NCT00976508|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736287|NCT00976508|Secondary|Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.|Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736288|NCT00976508|Secondary|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736289|NCT00976508|Secondary|Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736290|NCT00976508|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736291|NCT00976508|Secondary|Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
2736292|NCT00976508|Secondary|Serum Circulating Insulin-like Growth Factor (IGF-1) Levels|The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.|Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2736293|NCT00976508|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.|From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications.|||participants|||Number
2736294|NCT00976508|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From Screening to the follow-up visit (90 days after last dose of figitimumab)|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications.|||Participants|||Number
2736395|NCT00975715|Secondary|Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group|Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).|56 days|The Analysis set included all participants who received study drug and had data available for analysis.|||participants|||Number
2736295|NCT00976495|Secondary|Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)|||mmHg||Standard Error|Mean
2736296|NCT00976495|Secondary|Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)|||mmHg||Standard Error|Mean
2736297|NCT00976495|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)|||mmHg||Standard Error|Mean
2736298|NCT00976495|Primary|Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)|||% Change of Baseline GFR||Standard Error|Mean
2736299|NCT00976482|Primary|Two-year All-cause Mortality||2 years||||percentage of participants||95% Confidence Interval|Number
2736300|NCT00976456|Secondary|Overall Survival|Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).|42 months||||months||95% Confidence Interval|Median
2736301|NCT00976456|Primary|Progression Free Survival|Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).|42 months||||months||95% Confidence Interval|Median
2736302|NCT00976404|Secondary|Serious Adverse Events Attributed to Study Treatments|Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)|56 weeks||||serious adverse events|||Number
2736303|NCT00976404|Secondary|HIV Specific T-cell Response to Env|HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)|36 weeks||||response per 10^6 PBMCs||Standard Deviation|Median
2736304|NCT00976404|Secondary|Change From Baseline in CD4+ T Cell Count at Week 56||Week 56||||cells per mm^3||Inter-Quartile Range|Median
2736305|NCT00976404|Secondary|Change From Baseline in HIV DNA in Rectal Tissue at Week 56||Week 56||||log^10 copies per 10^6 cells||Inter-Quartile Range|Median
2736306|NCT00976404|Primary|Change From Baseline in HIV DNA in PBMCs at Week 56||56 weeks||||log^10 copies per 10^6 PBMCs||Inter-Quartile Range|Median
2736307|NCT00976391|Secondary|Change From Baseline in Body Weight at Weeks 36, 48 and 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed (represented by n=X, X in the category title).|||Kilograms||Standard Deviation|Mean
2736308|NCT00976391|Secondary|Change From Baseline in Body Weight at Week 26|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.|Baseline and Week 26|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.|||Kilograms||Standard Error|Least Squares Mean
2736335|NCT00975975|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.|||days||95% Confidence Interval|Median
2736309|NCT00976391|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 4 and <Week 8; HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 8 and <Week 12; HbA1c >8.5% and >=4 weeks since uptitration between >=Week 12 and <Week 16; HbA1c >8.0% and >=4 weeks since uptitration; HbA1c >7.5% and >=4 weeks between >Week 26 and >=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 52)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
2736310|NCT00976391|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7.0% at Week 26) were assessed.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
2736311|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category title).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2736312|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2736313|NCT00976391|Secondary|Change From Baseline in HbA1c at Weeks 36, 48 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2736314|NCT00976391|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 26.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2736315|NCT00976352|Secondary|Evaluation of Tidal Volume Benefit of rAAV1-CMV-GAA Gene Transfer and Respiratory Muscle Strength Training, Compared to Respiratory Muscle Strength Training Alone.|Best effort tidal volume, referenced to body mass, without use of ventilator assistance. Timeframe for respiratory muscle strength training alone was 90 days prior to dosing, timeframe post adminstration of rAAV1-CMV-GAA was 365 days.|Screening, Baseline, and Day 365 post study agent administration||||mL/kg||Full Range|Median
2736316|NCT00976352|Secondary|Evaluation of Ventilatory Performance Benefit of rAAV1-CMV-GAA Gene Transfer and Respiratory Muscle Strength Training (RMST) Compared to RMST Alone.|Median (range) maximal inspiratory pressure, in cm H2O. Timeframe for RMST training was 90 days prior to rAAV1-CMV-GAA gene transfer. Timeframe for following subjects after rAAV1-CMV-GAA gene transfer was 365 days.|Screening, Baseline, and 365 post study agent administration.||||cm H2O||Full Range|Median
2736317|NCT00976352|Secondary|Maximal Inspiratory Pressure|Median (range) Maximal Inspiratory Pressure (MIP), in cm H2O|Baseline and 365 post study agent administration||||cm H2O||Full Range|Median
2736318|NCT00976352|Primary|Safety Assessments of the rAAV1-CMV-GAA (Study Agent), Changes Post Study Agent Administration.|Change in Adeno-associated virus (AAV) antibody level; Change in Alglucosidase alpha (GAA) Antibody level|Change from baseline to 365 post study agent administration.||||mU/mL||Standard Deviation|Mean
2736319|NCT00976339|Secondary|Change in Mammographic Breast Density||1 year|Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.||||||
2736325|NCT00976248|Primary|Overall Response Rate of RAD001 in Patients With Previously Untreated WM|"Overall Response = Complete Response + Near Complete Response + Very Good Partial Response + Partial Response + Minor Response Complete Response: resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A near CR (nCR) is defined as fulfilling all CR criteria in the presence of positive immunofixation test for an IgM paraprotein.~Very Good Partial Response: > 90% reduction in serum IgM levels. Partial Response: > 50% reduction in serum IgM levels. Minor Response: 25-49% reduction in serum IgM levels Progressive Disease: greater than 25% increase in serum IgM level occurs from the lowest attained response value or progression of clinically significant disease related symptom(s).~Stable Disease: < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM"|End of Treatment, an average of 16 months||||participants|||Number
2736326|NCT00976209|Secondary|Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets|"Convenience was calculated based on total participants that completed the study.~Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:~Secondary Endpoint~Which product, if any, was more convenient?~The possible answers were:~I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)~I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)~or~• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.|||Percentage of participants|||Number
2736327|NCT00976209|Primary|Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion|"Preference was calculated based on total participants that completed the study.~Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:~Which product, if any, did you prefer for the relief of nasal congestion?~The possible answers were:~I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)~I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)~or~• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.|||Percentage of participants|||Number
2736328|NCT00976183|Secondary|Number of Participants With Progression Free Survival (PFS) up to 24 Months|Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression|2 years or 24 months||||participants|||Number
2736329|NCT00976183|Primary|Objective Response Rate|Clinical response was assessed by clinical, serologic, and radiographic means.|2 years or 24 months|Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|||participants|||Number
2736330|NCT00976027|Other Pre-specified|Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone|Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis|Day 0 before vaccination to Day 180 after vaccination|Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).|||Participants|||Number
2736331|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)|Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 14 (post-vaccination) up to 12 Months post-vaccination|The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).|||Participants|||Number
2736332|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)|Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 0 (pre-vaccination) up to the end of the influenza season|The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).|||Participants|||Number
2736333|NCT00976027|Primary|Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.|The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.|Day 0 (pre-vaccination) up to Year 1 post-vaccination|Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).|||Participants|||Number
2736334|NCT00975975|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.|||days||95% Confidence Interval|Median
2736338|NCT00975923|Primary|CLABSI and VAP Rates|Central line associated bloodstream infections(CLABSI) and ventilator associated pneumonias (VAP) using Centers for Disease Control and Prevention definitions as number of events per 1,000 device days, data collection and surveillance methods.|18 Months: 3-month baseline and quarterly post-intervention periods|A cluster randomized trial randomly assigned hospitals to either the Collaborative or Tool Kit groups, stratified by region within the United States and ICU volume. Implementation and analysis was at the level of the ICU. One of the 30 hospital in the Tool Kit Group was sold, leaving 29 hospitals. Analysis was conducted per protocol.|||events/1000 device days||Inter-Quartile Range|Median
2736339|NCT00975884|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 546|The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736340|NCT00975884|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 364|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736341|NCT00975884|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 21-days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 30 days post-Dose 2 vaccination (Days 182-212 in M6 groups)|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736342|NCT00975884|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21- days post-Dose 1 vaccination (Days 0-20 in both groups) and either 63 days post-Dose 2 vaccination (Days 21-84 in D21 groups) or 21 days post-Dose 2 vaccination (Day 182-203 in M6 groups) - Interim analysis at Day 182/203|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736343|NCT00975884|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Note: GSK2340272A 18-60 years (D21) GROUP and GSK2340272A >60 years (D21) GROUP presents results after the 2 vaccine dose; GSK2340272A 18-60 years (M6) GROUP and GSK2340272A >60 years (M6) GROUP presents result after 1 vaccine dose.|Within the 42-day (Days 0-41) post vaccination period - Interim analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736344|NCT00975884|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.|At Day 364|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.|||Participants|||Count of Participants
2736345|NCT00975884|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.|At Days 0, 21, 42 and 182|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.|||Participants|||Count of Participants
2736346|NCT00975884|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.|At Days 0, 21 and 42 - Interim analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.|||Participants|||Count of Participants
2739129|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|6 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2736347|NCT00975884|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and > 6 years old.|At Day 0 and 21 - Interim analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.|||Participants|||Count of Participants
2736348|NCT00975884|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)|An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 546|The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736349|NCT00975884|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 364|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736350|NCT00975884|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)|An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 364|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736351|NCT00975884|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)|An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 203 - Interim analysis posted at Day 182/203|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2736352|NCT00975884|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Diseases (pIMDs)|An AESI/pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 42 - Interim analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented.|||Participants|||Count of Participants
2736353|NCT00975884|Secondary|Duration of Solicited General Symptoms Occurring in Response to Individual Doses|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Days|Doses|Inter-Quartile Range|Median
2736354|NCT00975884|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2736355|NCT00975884|Secondary|Duration of Solicited General Symptoms Occurring in Response to Individual Doses|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim analysis posed at Day 42|The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Days|Doses|Inter-Quartile Range|Median
2736356|NCT00975884|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2736357|NCT00975884|Secondary|Duration of Solicited General Symptoms Occurring in Response to Individual Doses|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following first dose - Interim analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented, who filled in their symptom sheets.|||Days|Doses|Inter-Quartile Range|Median
2736411|NCT00975585|Secondary|Symptoms of Dryness|Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2736412|NCT00975585|Secondary|Bulbar Redness|The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2736358|NCT00975884|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2736359|NCT00975884|Secondary|Duration of Solicited Local Symptoms Occurring in Response to Individual Doses|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Days|Doses|Inter-Quartile Range|Median
2736360|NCT00975884|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2736361|NCT00975884|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses - Interim Analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2736362|NCT00975884|Secondary|Duration of Solicited Local Symptoms Occurring in Response to Individual Doses|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Days|Doses|Inter-Quartile Range|Median
2736363|NCT00975884|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following first dose - Interim Analysis posted at Day 42|The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2736364|NCT00975884|Secondary|Percentage of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09|Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Netherlands/602/09. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 21 and 42|The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.|||Percentage of subjects||95% Confidence Interval|Number
2736365|NCT00975884|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.|At Days 0, 21 and 42|The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2736366|NCT00975884|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.|At Day 364|The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.|||Ratio||95% Confidence Interval|Geometric Mean
2736367|NCT00975884|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.|At Day 203|The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.|||Ratio||95% Confidence Interval|Geometric Mean
2736368|NCT00975884|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.|At Day 182|The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.|||Ratio||95% Confidence Interval|Geometric Mean
2736369|NCT00975884|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.|At Day 21 and 42|The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.|||Ratio||95% Confidence Interval|Geometric Mean
2736370|NCT00975884|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.|At Day 364|The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.|||Participants|||Count of Participants
2736371|NCT00975884|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.|At Day 203|The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.|||Participants|||Count of Participants
2736372|NCT00975884|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.|At Day 182|The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
2736373|NCT00975884|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.|At Days 0, 21 and 42|The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.|||Participants|||Count of Participants
2736374|NCT00975884|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 364|The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.|||Participants|||Count of Participants
2736375|NCT00975884|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 203|The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.|||Participants|||Count of Participants
2736413|NCT00975585|Secondary|Limbal Redness|The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2736376|NCT00975884|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 182|The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
2736377|NCT00975884|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 21 and 42|The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.|||Participants|||Count of Participants
2736378|NCT00975884|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 364|The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.|||Titers||95% Confidence Interval|Geometric Mean
2736379|NCT00975884|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 203|The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.|||Titers||95% Confidence Interval|Geometric Mean
2736380|NCT00975884|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 182|The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2736381|NCT00975884|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease|Titres are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 0, 21 and 42|The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2736382|NCT00975884|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.|At Day 21|The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.|||Ratio||95% Confidence Interval|Geometric Mean
2736383|NCT00975884|Primary|Percentage of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 21|The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.|||Percentage of subjects||95% Confidence Interval|Number
2736384|NCT00975884|Primary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.|At Day 21|The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.|||Participants|||Count of Participants
2736385|NCT00975884|Primary|Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.|At Day 21|The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.|||Participants|||Count of Participants
2736386|NCT00975806|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the start of study drug therapy to death.|Day 1 of study drug to death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
2736387|NCT00975806|Secondary|Duration of Response|Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)|Day 1 of initial response date to progressive disease|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
2736388|NCT00975806|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.|Day 1 of study drug to disease progression or death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
2736389|NCT00975806|Secondary|Phase 1 : Tumor Response Rate According to RECIST 1.1|"Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria:~Treatment response includes both complete response and partial response~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir"|Every 3 cycles; up to month 25|Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported.|||participants|||Number
2736390|NCT00975806|Secondary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death|First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
2736391|NCT00975806|Primary|Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|"Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions.~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir."|After at least 3 cycles of treatment|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
2736392|NCT00975806|Primary|Phase 1: Maximum Tolerated Dose (MTD)|"The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were:~• Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:~Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days~Febrile neutropenia~Gr 4 neutropenia lasting for ≥ 7 days~Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT.~If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation."|Within 21 days of first dose of treatment|Safety population includes all participants who received at least one dose of the study drug.|||mg|||Number
2736393|NCT00975780|Secondary|Lower Respiratory Tract Infection Other Than Pneumonia|The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.|2.5 years||||participants|||Number
2736394|NCT00975780|Primary|Pneumonia|The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.|2.5 years||||participants|||Number
2736396|NCT00975715|Secondary|Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type|Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.|28 days|Analyzed set includes all participants who received study drug and had both baseline and post baseline data available.|||percentage change in seizure frequency||Standard Deviation|Mean
2736397|NCT00975715|Secondary|Percent of Participants With Response During Double-blind Phase, by Treatment Group|Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.|screening to 28 days|The Full Analysis set included all participants who received study drug.|||percentage of participants|||Number
2736398|NCT00975715|Secondary|Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group|"Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days) = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28."|baseline, 28 days and 56 days|The Full Analysis set included all participants who received study drug.|||seizures per 28 days||Standard Deviation|Mean
2736399|NCT00975715|Primary|Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group|"Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: Percent change in partial onset seizure frequency per 28 days from the screening phase = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 Partial onset seizure frequency per 28 days = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28."|screening and 28 days|The Full Analysis set included all participants who received study drug.|||percentage change per 28 days||Standard Deviation|Mean
2736400|NCT00975689|Primary|Oxysterol Levels||Six months|Every patient in the trial received the study drug as well as the placebo.|||ng/mL||Standard Error|Mean
2736401|NCT00975650|Primary|Percentage of Subjects With Cavg Within the Reference Range|The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.|Each period is 7 days|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||Participants|||Count of Participants
2736402|NCT00975650|Primary|Serum Dihydrotestosterone Cavg||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
2736403|NCT00975650|Primary|Serum Dihydrotestosterone Ln-AUCt||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng.h/dL||Standard Deviation|Mean
2736404|NCT00975650|Primary|Serum Dihydrotestosterone Ln-Cmax||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
2736405|NCT00975650|Primary|Serum Testosterone Cavg||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
2736406|NCT00975650|Primary|Serum Testosterone Ln-AUCt||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng.h/dL||Standard Deviation|Mean
2736407|NCT00975650|Primary|Serum Testosterone Ln-Cmax|The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.|0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
2736408|NCT00975637|Secondary|Change in Percent of Body Surface Area (BSA) Affected by Psoriasis|To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred.|Baseline and Week 12||||percentage improvement in BSA||Standard Deviation|Mean
2736409|NCT00975637|Primary|Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12|At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.|Baseline and 12 weeks||||percentage of psoriasis improvement||Standard Deviation|Mean
2736410|NCT00975611|Primary|Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.||week 4 and week 8|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.||||||
2756304|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2736416|NCT00975585|Primary|Visual Acuity|Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|2 weeks||||logMAR units||Standard Error|Least Squares Mean
2736417|NCT00975585|Primary|Average Corneal Staining|The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.|2 weeks|Analysis included all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2736418|NCT00975507|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
2736419|NCT00975507|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
2736420|NCT00975507|Secondary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||Participants|||Number
2736421|NCT00975507|Secondary|Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
2736422|NCT00975507|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.|||Participants|||Number
2736423|NCT00975481|Primary|Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)|ARCI (BG) is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select 'False' / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects. Emax: largest effect score between 0 - 24 hours post-dose. Emin: smallest effect score between 0 - 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on Scale||Standard Deviation|Mean
2736424|NCT00975481|Primary|Other Subjective Effects- Drug Similarity|Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar). Recently received drugs were compared with placebo, benzodiazepines, codeine/morphine, Tetrahydrocannabinol (THC), pseudoephedrine.|12 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period. 'n' is signifying those participants who were evaluated for this measure for various drugs for similarity in each treatment group.|||mm||Standard Deviation|Mean
2736425|NCT00975481|Primary|Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])|Any drug effects VAS is one of the measures of other subjective effects. It assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is the largest effect score between 0.5 to 24 hours post-dose.|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736426|NCT00975481|Primary|Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)|"Alertness/Drowsiness VAS is one of the measures of sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither drowsy nor alert (score of 50 mm), on the left with very drowsy (score of 0 mm) and on the right with very alert (score of 100 mm). Emin is the smallest effect score between 0 to 24 hours post-dose."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2739130|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day post drug administration 2||||score on a scale||Standard Error|Mean
2736427|NCT00975481|Primary|Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)|ARCI (PCAG) is one of the measures of sedative effects. It is a set of 15 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when answer is opposite to scoring direction. Score range: 0 to 15, higher score indicated higher sedative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on Scale||Standard Deviation|Mean
2736428|NCT00975481|Primary|Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)|ARCI (LSD) is one of the measures of negative effects. It is a set of 14 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to scoring direction. Score range: 0 to 14, higher score indicated higher negative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on Scale||Standard Deviation|Mean
2736429|NCT00975481|Primary|Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])|"Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is largest effect score between 0.5 to 24 hrs."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736430|NCT00975481|Primary|Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])|"High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is largest effect score between 0 to 24 hours."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736431|NCT00975481|Primary|Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])|"Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is the largest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736432|NCT00975481|Primary|Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)|ARCI (MBG) is one of the measures of positive effects. It is a set of 16 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to the scoring direction. Score range: 0 to 16, higher score indicated positive effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on scale||Standard Deviation|Mean
2736433|NCT00975481|Primary|Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)|SDV is one of measures of balance of effects. It is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values. Participants were asked to choose between receiving another dose of same drug or an envelope containing specified amount of money, but they did not receive drug or money as described. Possible score range from 0.25 to 50. Higher score range indicates higher SDV. Emax: largest effect score between 6-24 hours post-dose.|6, 12, 24 hrs post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Dollar||Standard Deviation|Mean
2736434|NCT00975481|Primary|Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Good and Bad effects VAS is one of the measures of balance of effects that assesses the effect experienced by the participant on a 100 mm bipolar VAS, anchored in the center with a neutral anchor of neither good nor bad effects (score of 50 mm), on the left with bad effects(score of 0 mm) and on the right with good effects (score of 100 mm).~Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736453|NCT00975221|Secondary|Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).|||percent change||Standard Error|Least Squares Mean
2736435|NCT00975481|Primary|Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])|"Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely not, 50 mm = do not care, and 100 mm = definitely so).~Emax is largest effect score between 6 hours to 24 hours."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736436|NCT00975481|Primary|Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm= neither like nor dislike, and 100 mm= strong liking).~Emax is the largest effect score between 6 to 24 hours post-dose. Emin is the smallest effect score between 6 to 24 hours post-dose."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736437|NCT00975481|Primary|Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm).~Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis population included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
2736438|NCT00975416|Other Pre-specified|Drug Craving|Cocaine Craving Questionnaire|Post-treatment|||||||
2736439|NCT00975416|Primary|Therapeutic Alliance|"Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance).~Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance)."|Post 12 weeks treatment with cognitive behavioral therapy|Number of participants for analysis was determined by the number of participants who had post-treatment outcome measures.|||units on a scale||Standard Deviation|Mean
2736440|NCT00975286|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2736441|NCT00975286|Secondary|Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline DTSQ assessment during on-treatment period. Missing data was imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2736442|NCT00975286|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-blind Period|Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2736443|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2736924|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Creatinine|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736444|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2736445|NCT00975286|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2736446|NCT00975286|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period. Missing data was imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
2736447|NCT00975286|Secondary|Change From Baseline in Average Insulin Glargine Daily Dose at Week 24|Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline insulin glargine dose assessment during on-treatment period. Missing data was imputed using LOCF.|||units per day||Standard Error|Least Squares Mean
2736448|NCT00975286|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period. Missing data was imputed using LOCF.|||kilogram||Standard Error|Least Squares Mean
2736449|NCT00975286|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period. Missing data was imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
2736450|NCT00975286|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period. Missing data was imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
2736451|NCT00975286|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period. Missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
2736452|NCT00975286|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. Last observation carried forward used.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2744161|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||pg/ml||Standard Deviation|Mean
2736454|NCT00975221|Secondary|Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).|||percent change||Standard Error|Least Squares Mean
2736455|NCT00975221|Secondary|Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.|||percentage of participants|||Number
2736456|NCT00975221|Primary|Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP||Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.|||percentage of participants|||Number
2736457|NCT00975195|Secondary|Change in On-treatment Physician Global Evaluation|"Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736458|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736459|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736460|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736461|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736462|NCT00975195|Secondary|Change in On-treatment PEFR as Measured by Home Based Spirometry|Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set|||Litres/sec||Standard Error|Least Squares Mean
2736463|NCT00975195|Secondary|Change in On-treatment FVC as Measured by Home Based Spirometry|Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set|||Litres||Standard Error|Least Squares Mean
2736464|NCT00975195|Secondary|Change in On-treatment FEV1 as Measured by Home Based Spirometry|Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set|||Litres||Standard Error|Least Squares Mean
2736465|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to extremely/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
2736466|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to a lot/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
2736467|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to a lot/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
2736468|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to extremely/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
2736469|NCT00975195|Secondary|Change in On-treatment BODE Index|Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736470|NCT00975195|Secondary|Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)|Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set|||meters||Standard Error|Least Squares Mean
2736471|NCT00975195|Secondary|Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)|Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set|||kg/m2||Standard Error|Least Squares Mean
2736472|NCT00975195|Secondary|Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale|"Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.~Scale from 0 to 4:~0 = not troubled by breathlessness, except during strenuous exercise~1 = short of breath when hurrying or walking up a slight hill~2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace~3 = stops for breath after approximately 100 yards, or after a few minutes on the level~4 = too breathless to leave the house, or breathless when dressing or undressing~No breathlessness was given a score of -1~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 18 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
2736473|NCT00975195|Secondary|Change in On-treatment Lung Function as Measured by Trough FEV1|Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18 and 52 visits|Treated set|||Litres||Standard Error|Least Squares Mean
2736474|NCT00975195|Secondary|Severity of On-treatment COPD Exacerbations|Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
2736475|NCT00975195|Secondary|Proportion of Patients With at Least One On-treatment COPD Exacerbation|Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
2736476|NCT00975195|Secondary|Number of On-treatment COPD Exacerbations|"Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.~Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set|||exacerbations per patient-year||95% Confidence Interval|Mean
2736477|NCT00975195|Secondary|Time to First On-treatment COPD Exacerbation|"Time to first on-treatment COPD exacerbation of any severity. The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set|||days||95% Confidence Interval|Number
2736594|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736478|NCT00975195|Secondary|Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.|Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
2736479|NCT00975195|Secondary|Number of Severe On-treatment COPD Exacerbations|"Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set|||exacerbations per patient-year||95% Confidence Interval|Mean
2736480|NCT00975195|Secondary|Time to First Severe On-treatment COPD Exacerbation|"Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set|||days||95% Confidence Interval|Number
2736481|NCT00975195|Secondary|Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation|Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
2736482|NCT00975195|Secondary|Number of Moderate or Severe On-treatment COPD Exacerbations|"Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.~Measured values show adjusted mean event rate."|During randomised treatment, up to 488 days|Treated Set|||exacerbations per patient-year||95% Confidence Interval|Mean
2736483|NCT00975195|Primary|Time to First Moderate or Severe On-treatment COPD Exacerbation|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set|||days||95% Confidence Interval|Number
2736484|NCT00975156|Secondary|6 Minute Walking Distance (6MWD)||Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention||||meters (m)||Standard Deviation|Mean
2736485|NCT00975156|Primary|10-meter Walking Test (10mWT)||Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention|Analysis was determined per protocol (i.e.between-group variation)|||meters per second (m/s)||Standard Deviation|Mean
2736486|NCT00975143|Primary|Co-Primary Outcome 2: Proportion of Patients Who Achieve at Least a 90% Reduction in Total Number of Nodular Lesions (Facial and Truncal).|"The percentage of patients in each group who achieved ≥90% reduction in the total nodular lesion count from Baseline to Week 20 was calculated along with its 95% CI (normal approximation). A 95% 2-sided CI on the difference between treatments (CIP-ISOTRETINOIN minus Isotretinoin) was also computed.~Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference > -10."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.|||percentage of participants||95% Confidence Interval|Number
2736487|NCT00975143|Secondary|Proportion of Patients Who Are Rated as Clear/Almost Clear on the Six-point Physicians' Global Assessment Scale (PGSA).|PGSA categories: 1 (Almost clear); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very severe). A grade of either 0 (clear) or 1 (almost clear) on the 6-point PGSA scale within the Week 20 analysis window was considered a success.|20 weeks|Analysis based on the Per Protocol (PP) Population. Patients with a Baseline PGSA score of 0 or 1 (i.e., who had primarily truncal lesions at Baseline) were excluded from the analysis, as PGSA evaluated facial lesions.|||percentage of participants||95% Confidence Interval|Number
2736595|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736488|NCT00975143|Primary|Co-primary Outcome 1: Change From Baseline in Total Nodular Lesion Count (Facial and Truncal)|"The change from Baseline to Week 20 in the total number of nodular lesions was calculated as the Week 20 lesion count minus Baseline lesion count and compared using Analysis of Covariance (ANCOVA), controlling for Baseline total nodular lesion count, gender and analysis site.~The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was also calculated using the ANCOVA model.~Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference < 4."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.|||Lesions||Standard Deviation|Mean
2736489|NCT00975130|Secondary|Percentage of Participants Achieving Remission|Remission was defined as achievement of a DAS28-ESR < 2.6.|Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.|||Percentage of Participants||95% Confidence Interval|Number
2736490|NCT00975130|Secondary|Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12|"The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time.~The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale."|End of Month 6, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.|||Units on a Scale||Standard Deviation|Mean
2736491|NCT00975130|Secondary|Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8|The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
2736492|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736493|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736494|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736596|NCT00975130|Secondary|Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736495|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736496|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736497|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736498|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736499|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736500|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736516|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736501|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736502|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736503|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736504|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736505|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736506|NCT00975130|Secondary|Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6|Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736507|NCT00975130|Secondary|Number of Participants Who Achieved Minimal or Absence of Functional Impairment|The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
2736508|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736509|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736510|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736511|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736512|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736513|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736514|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736515|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2739131|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day prior to drug administration 2||||score on a scale||Standard Error|Mean
2736517|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736518|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736519|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736520|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736521|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736522|NCT00975130|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736523|NCT00975130|Secondary|Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6|The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
2736524|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-CRP EULAR Response|DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
2736525|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-ESR EULAR Response|EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Participants|||Number
2736526|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736527|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736528|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736529|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736530|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736531|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736532|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736675|NCT00974922|Secondary|Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP.||6 weeks|Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.||||||
2736533|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736534|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736535|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736536|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736537|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736538|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736539|NCT00975130|Secondary|Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736746|NCT00974142|Secondary|Effects of Cyclosporin A on Respiratory Function - Change in the Percentage of Post Predicted Value of Forced Vital Capacity|Outcome measured the change in the percentage of post predicted value of forced vital capacity at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||Percentage of post predicted value||Full Range|Median
2736540|NCT00975130|Secondary|Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736541|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736542|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736543|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736544|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736545|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736546|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736547|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736548|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736549|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736550|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736551|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736552|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736553|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736597|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736554|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736555|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736556|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736557|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736558|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736559|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736560|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736561|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736562|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736563|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736564|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736565|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736566|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736567|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736598|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736568|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736569|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736570|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736571|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736572|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
2736573|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736574|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736676|NCT00974922|Primary|Change From Baseline in Ambulatory Diastolic Blood Pressure|The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency.|six weeks|Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.||||||
2736575|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736576|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736577|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736578|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR or at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736579|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736580|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736581|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736582|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736592|NCT00975130|Secondary|Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736583|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736584|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736585|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736586|NCT00975130|Secondary|Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736587|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736588|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736589|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736590|NCT00975130|Secondary|Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||mg/L||Standard Deviation|Mean
2736591|NCT00975130|Secondary|Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736593|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736599|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736600|NCT00975130|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
2736601|NCT00975130|Secondary|Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736602|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736603|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736604|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736605|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||mm/h||Standard Deviation|Mean
2736606|NCT00975130|Secondary|Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736607|NCT00975130|Secondary|Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736608|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736609|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736610|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736611|NCT00975130|Secondary|Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736612|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736613|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736614|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736615|NCT00975130|Secondary|Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
2736616|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736617|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736618|NCT00975130|Secondary|mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736636|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736619|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736620|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
2736621|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736622|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736623|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736624|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736625|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736626|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736674|NCT00974974|Primary|"Percentage of Off Time During Waking Hours at End of Study"|"Percentage of off time during waking hours at end of study is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects|||percentage||Standard Deviation|Mean
2736627|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736628|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736629|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736630|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
2736631|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736632|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736633|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736634|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736635|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Tender Joints||Standard Deviation|Mean
2736637|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736638|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736639|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736640|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736641|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736642|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736643|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736644|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736645|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
2736646|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736677|NCT00974818|Primary|Response to Treatment|will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.|2 years|Due to a lack of patients accrued to the protocol the protocol was closed and the analysis of the 2 year relapse rates could not be compared.|||participants|||Number
2736647|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736648|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736649|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736650|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Swollen Joints||Standard Deviation|Mean
2736651|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736652|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736653|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736654|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736655|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736656|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736657|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736658|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736659|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736660|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
2736661|NCT00975130|Primary|Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12|The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6.|Start of Month 11, End of Month 12|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
2736662|NCT00975130|Primary|Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6|EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units|Month 6|The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation.|||Participants|||Number
2736663|NCT00975000|Secondary|Time to Parathyroidectomy||56 weeks|Full analysis set who underwent a parathyroidectomy||||||
2736664|NCT00975000|Secondary|Percentage of Participants With a Parathyroidectomy||56 weeks|Full analysis set|||percentage of participants|||Number
2736665|NCT00975000|Secondary|Change From Baseline to the EAP in Urine Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data|||mg/dL||Standard Deviation|Mean
2736666|NCT00975000|Secondary|Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set|||pg/mL||Standard Deviation|Mean
2736667|NCT00975000|Secondary|Change From Baseline to the EAP in Corrected Total Calcium||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set|||mg/dL||Standard Deviation|Mean
2736668|NCT00975000|Secondary|Change From Baseline to Week 52 in eGFR|eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Baseline and Week 52|Full analysis set with available data|||mL/min/1.73 m²||Standard Deviation|Mean
2736669|NCT00975000|Secondary|Change From Baseline to the EAP in Mean Serum Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data|||mg/dL||Standard Deviation|Mean
2736670|NCT00975000|Secondary|Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck|Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).|Baseline and Week 52|Full analysis set with available data|||percent change||Inter-Quartile Range|Median
2736671|NCT00975000|Primary|Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)||Weeks 21 to 26 (EAP)|Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)|||percentage of participants|||Number
2736672|NCT00974974|Secondary|"On Time Without Troublesome Dyskinesia"|"On time without troublesome dyskinesiais measured by using the Parkinson's disease diary. On time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."|22 weeks|All randomized subjects|||hours||Standard Deviation|Mean
2736673|NCT00974974|Secondary|"Off Time"|"Off time hours is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects|||hours||Standard Deviation|Mean
2736678|NCT00974675|Primary|Accumulation Ratio (R0) for CAT-354|Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2736679|NCT00974675|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to Day 147|Safety population included all participants who received at least 1 dose of IMP (CAT-354 or placebo) including those who did not complete the study.|||participants|||Number
2736680|NCT00974675|Primary|Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose||Day 84|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2736681|NCT00974675|Primary|Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose||Pre-dose on Day 56|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2736682|NCT00974675|Primary|Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose||Pre-dose on Day 28|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2736683|NCT00974675|Primary|Volume of Distribution (Vd) for CAT-354 After First Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||mL/kg||Standard Deviation|Mean
2736684|NCT00974675|Primary|Clearance (CL) for CAT-354 After First Dose|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||(mL/day)/kilogram||Standard Deviation|Mean
2736685|NCT00974675|Primary|Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose|Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||days||Standard Deviation|Mean
2736686|NCT00974675|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||(mcg*day)/mL||Standard Deviation|Mean
2736687|NCT00974675|Primary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||(mcg*day)/mL||Standard Deviation|Mean
2736688|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2736689|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2736690|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
2736728|NCT00974311|Primary|Overall Survival|Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).|During study period (up to 101 months)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2736691|NCT00974571|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736692|NCT00974571|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736693|NCT00974571|Secondary|Mean Change From Baseline in Composite Symptoms Score|Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.|||Score 0 (best) to 3 (worst)||95% Confidence Interval|Least Squares Mean
2736694|NCT00974571|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736695|NCT00974571|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 4 weeks of a 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736696|NCT00974480|Secondary|Tolerance Evaluated by Investigator.|"Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale.~Scaling, Dryness and Erythema Evaluations~- None (0) - Very Severe = (4)~Burning and Itching Evaluation Scale~None (0) = Normal, no discomfort~Mild (1) = Slight discomfort that is not bothersome~Moderate (2) = Discomfort that is somewhat bothersome~Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities~Severe (4) = Continuous discomfort that interferes with normal daily activities"|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
2736697|NCT00974480|Secondary|Facial Skin Self-evaluation.|A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
2736698|NCT00974480|Secondary|Sensitivity of the Face Evaluated by Subject.|"Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately.~Each score is from 0 = absent to 10 important."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
2736699|NCT00974480|Secondary|Clinical Skin Evaluation.|A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
2736700|NCT00974480|Secondary|Area Ratio - Analysis of Skin Replicas of Crow's Feet.|An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling.|24 weeks|Only the per protocol (PP) population was considered for this analysis. Early termination and lost subjects were excluded from this analysis. Furthermore, some replicas of subjects who completed the study could not be analyzed with precision and were consequently excluded from the analysis by the laboratory.|||mm²||Standard Deviation|Mean
2736701|NCT00974480|Secondary|Skin Elasticity.|Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||kilo Pascals||Standard Deviation|Mean
2736702|NCT00974480|Secondary|Skin Hydration (Conductance)|"Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe.~Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||µsiemens (µmho)||Standard Deviation|Mean
2749880|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
2736703|NCT00974480|Secondary|Trans-epidermal Water Loss (TEWL).|Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||g / m² / h||Standard Deviation|Mean
2736704|NCT00974480|Secondary|Photographic Evaluation by a Panel of Blinded Dermatologists.|"A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind.~When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as improvement. When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as worsening. When there was no noticeable difference between the photographs, it was scored as stable."|24 weeks|Analysis was intent to treat (ITT). Photographs taken at early termination visit were not available for every early termination subject as some subjects refused to have their photographs taken. Thus, early termination and lost to follow-up subjects were excluded from this analysis. The total number of subjects included in the ITT analysis was 92.|||Participants|||Number
2736705|NCT00974480|Primary|Skin Aging Measured With the Photonumeric Scale.|Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
2736706|NCT00974376|Primary|Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period|Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).|12 weeks|Two participants in the gabapentin group and one in the placebo group were lost to follow up after randomization and did not submit any UDS for testing while on study. Two participants in the placebo group withdrew from the study at the week 1 visit, and thus did not submit any UDS for testing while on study.|||percentage of negative UDS||Standard Deviation|Mean
2736707|NCT00974363|Secondary|Antibody Concentrations Against the Vaccine Polysaccharides|Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).|At Month 24 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2736708|NCT00974363|Secondary|Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides|Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).|At Month 24 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
2736709|NCT00974363|Secondary|Antibody Titers Against the Vaccine Meningococcal Serogroups|Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals' laboratory.|At Months 24, 36, 48 and 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Titers||95% Confidence Interval|Geometric Mean
2736710|NCT00974363|Secondary|Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups|A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals' laboratory.|At Months 24, 36, 48 and 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
2736711|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
2736729|NCT00974259|Secondary|Relative Risk of Good Outcome of ICP/PbtO2 Group Compared to ICP Only Group.|"Dichotomized Glagow Outcome Score-Extended:~GOSE 1-4 = Poor Outcome GOSE 5-8 = Good Outcome GOSE is a 8-point scale, with 1 = death, 8 = full recovery."|6 months||||participants|||Number
2736947|NCT00972543|Primary|Static Physician Global Assessment Hands and Feet (sPGA - H&F)|Minimum possible score 0, maximum possible score 4.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit|Results not analysed due to early termination of the study||||||
2736712|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 48 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
2736713|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 36 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
2736714|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.|At Month 24 post primary dose|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
2736715|NCT00974311|Other Pre-specified|Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)|Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.|Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)|Safety population was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2736716|NCT00974311|Other Pre-specified|Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)|Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval > 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.|Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)|Safety population was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2736717|NCT00974311|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (>) 180 millimeter of mercury (mmHg) and >40 mmHg increase from baseline (BL) and less than (<) 90 mmHg and >30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result >105 mmHg and >30 mmHg increase from BL and absolute result < 50 mmHg and >20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result > 120 beats per minute (bpm) and >30 bpm increase from BL and absolute result < 50 bpm and >20 bpm decrease from BL or any abnormalities in heart rate. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.|Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)|Safety population was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2736718|NCT00974311|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events which occurred between first dose of study drug and up to the safety follow-up visit or the initiation of another anti-neoplastic therapy, whichever occurred first (up to 101 months). AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.|Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)|Safety population was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2736719|NCT00974311|Secondary|Percentage of Participants With Circulating Tumor Cell (CTC) Conversion|CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.|Baseline up to 24 months|CTC evaluable population included participants with a baseline and at least 1 post baseline CTC assessment.|||percentage of participants||95% Confidence Interval|Number
2736720|NCT00974311|Secondary|European Quality of Life Five-Domain (EQ-5D) Scale|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.|Week 13|Evaluable ITT included participants who were part of the ITT Population and who were evaluable for EQ-5D.|||units on a scale||Standard Deviation|Mean
2736721|NCT00974311|Secondary|Percentage of Participants With Soft-tissue Objective Response|The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators' response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.|During DB phase (up to 24 months)|ITT with measurable disease population included participants who were part of the ITT Population and had measurable soft tissue disease at screening, defined by at least 1 target lesion according to RECIST v1.1.|||Percentage of participants|||Number
2736722|NCT00974311|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.|During DB phase (up to 24 months)|Evaluable ITT population included participants who were part of the ITT Population and had a PSA level measured at baseline and at least 1 post-baseline assessment.|||Percentage of participants|||Number
2736723|NCT00974311|Secondary|Percentage of Participants With Pain Palliation|The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.|Baseline up to 24 months|Evaluable ITT Population included participants with metastatic bone disease at baseline; provided answers to Question #3 of the Brief Pain Inventory – Short Form for a minimum of 4 out of 7 days in the baseline run-in period; stable baseline pain; stable analgesic use; and had an average pain score during the baseline run-in period of >= 4.|||Percentage of participants||95% Confidence Interval|Number
2736724|NCT00974311|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).|Baseline and at every study visit from Week 13 while on study drug (up to 24 months)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2736725|NCT00974311|Secondary|Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)|The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.|Baseline up to 24 months|Evaluable intent to treat (ITT) - all participants who were part of the ITT population and had a global FACT-P score at baseline and at least 1 post-baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2736726|NCT00974311|Secondary|Time to First Skeletal-related Event|The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.|During DB Phase (up to 24 months)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2736727|NCT00974311|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.|During DB phase (up to 24 months)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2736734|NCT00974246|Primary|To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.|FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks||||units on a scale||Standard Deviation|Mean
2736735|NCT00974246|Primary|To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0|The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks||||units on a scale||95% Confidence Interval|Mean
2736736|NCT00974233|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|Overall survival (OS) was measured for all enrolled subjects as the time from the day of first study drug administration until death from any cause.|||months||95% Confidence Interval|Median
2736737|NCT00974233|Secondary|Toxicities Observed With Induction Chemotherapy and Maintenance Therapy|Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.|||participants|||Number
2736738|NCT00974233|Secondary|Objective Response Rate (Complete + Partial Responses)|Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)||||participants|||Number
2736739|NCT00974233|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)||||Proportion of participants||95% Confidence Interval|Median
2736740|NCT00974233|Primary|Progression Free Survival|The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|The study was designed to test the null hypothesis that the median PFS with induction BR and maintenance lenalidomide is at most 18 months versus the alternative hypothesis that median PFS is >18 months, at a one-sided significance level of 0.10 with a power of 80%.|||months||95% Confidence Interval|Median
2736741|NCT00974220|Secondary|Cycle Exercise Endurance Time|Constant workrate cycle endurance during tests at 75% of the peak incremental workrate|10-minutes post-treatment|Subjects completing both treatment arms were included in this analysis|||minutes||Standard Error|Mean
2736742|NCT00974220|Primary|Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise|"The 10-point Borg scale ranges from 0 nothing at all to 10 maximal/extremely strong and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests."|10-minutes post-treatment|Subjects who completed both treatment arms of the crossover study were included in the primary analysis.|||units on a scale||Standard Error|Mean
2736743|NCT00974142|Secondary|Effects of Cyclosporin A on Symptoms - Change in Scores on a Shortness of Breath Scale|Scores on a shortness of breath scale (University of California at San Diego Dyspnea scale): shortness of breath questionnaire scores are summed as a total score ranging from 0-120 with higher scores indicating more severe breathlessness. Assessments were performed at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||units on a scale||Full Range|Median
2736744|NCT00974142|Secondary|Effects of Cyclosporin A on Respiratory Function - Change in Exercise Capacity by a Shuttle Walk Distance Measured in Feet|Measurement of exercise capacity by a shuttle walk distance measured in feet at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). The purpose of the shuttle walk test is to see how far and fast a patient can walk (without stopping for a rest) by following a series of time signals.Values expressed as median (full range).|at Week 8 and Week 16||||feet||Full Range|Median
2736745|NCT00974142|Secondary|Effects of Cyclosporin A on Respiratory Function - Change in the Percentage of Post Predicted Value of Forced Expiratory Volume in 1 Second|Outcome measured the change in the percentage of post predicted value of forced expiratory volume in 1 second at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||Percentage of post predicted value||Full Range|Median
2749881|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
2736747|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8+ Tumor Necrosis Factor|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - CD8+ tumor necrosis factor at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
2736748|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 4+ Interleukin-2|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - cluster of differentiation 4+ interleukin-2 at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
2736749|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8+ Interferon Gamma|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - CD8+interferon gamma at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
2736750|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8 and Major Histocompatibility Complex II|Outcome measured the change in the percentage of peripheral blood cells expressing biomarker - cluster of differentiation 8 (CD8), major histocompatibility complex (MHC) II at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
2736751|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over 16 Week Treatment Interval - Change in the Percentage of Cluster of Differentiation 8 and Cluster of Differentiation 28|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - cluster of differentiation 8 (CD8), cluster of differentiation 28 (CD28) at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
2736752|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over 16 Week Treatment Interval - Change in the Percentage of Cluster of Differentiation 4 (CD4)|Outcome measured the change in the percentage of cluster of differentiation 4 (CD4) at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
2736753|NCT00974142|Secondary|Pharmacokinetic - Pharmacodynamic Relationship of Oral Cyclosporine and Biomarkers of an Adaptive Immune Response - Cyclosporine Blood Levels|Cyclosporine blood levels on therapy over 16 week treatment interval were measured at Weeks 2, 4, 6, 8, 10, 12 & 16. The median for each participant was found and then the overall median was determined. Values expressed as median (full range).|16 weeks|Cyclosporine blood levels were not analyzed in placebo group.|||ng/mL||Full Range|Median
2736754|NCT00974142|Primary|Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients - Number of Patients That Developed Infection Requiring Systemic Antibiotic Therapy|Clinical diagnosis of infection which requires systemic antibiotic therapy during the 16 week study interval at Week 2, 4, 6, 8, 10, 12 and 16. Outcome measured the number of subjects who developed an infection requiring systemic antibiotic therapy during the study treatment interval.|16 weeks||||Participants|||Count of Participants
2736755|NCT00974142|Primary|Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients - Number of Patients That Developed Renal Insufficiency|Development of renal insufficiency defined as > 30% elevation in serum creatinine above baseline which required dose modification of the cyclosporine over 16 week treatment interval at Week 2, 4, 6, 8, 10, 12 and 16. Outcome measured the number of subjects who developed renal insufficiency during the study treatment interval.|16 weeks||||Participants|||Count of Participants
2736756|NCT00974142|Primary|Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients- Nephrotoxicity - Measured by Serum Creatinine|Measurement of nephrotoxicity by monitoring serum creatinine over 16 week treatment interval. Mean serum creatinine values were assessed at Week 2, 4, 6, 8, 10, 12 and 16. The mean values of all measurements for each participant were calculated and then the mean across participants was calculated. Values expressed as mean ± SD.|16 weeks||||mg / dL||Standard Deviation|Mean
2736757|NCT00974090|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
2736758|NCT00974090|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg・hr/dL||Standard Error|Least Squares Mean
2736759|NCT00974090|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
2736948|NCT00972543|Primary|Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
2736760|NCT00974090|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
2736761|NCT00974051|Primary|Blood Glucose Nadir|BG nadir overnight after intervention|overnight hours||||mg/dl||Standard Deviation|Mean
2736762|NCT00974051|Secondary|Percent of Nighttime Glucose Levels >250 mg/dl||10:00pm to 6:00am||||percentage of overnght glucose values|||Number
2736763|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <70||10:00pm to 6:00am||||percentage of nighttime glucose values|||Number
2736764|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <80||9:00pm to 6:00am||||percentage of overnight glucose levels|||Number
2736765|NCT00973973|Secondary|Number of Days to First Posttreatment Menses|Defined as the number of days from the last dose of study drug until the start date of the first post-treatment menses.|From last day of study drug up to 6 weeks after the last dose.|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) with non-missing post-treatment data.|||days||Full Range|Median
2736766|NCT00973973|Secondary|Percentage of Days With Uterine Bleeding During the Double- Blind Treatment Phase|"Uterine bleeding was reported daily by participants during the study using the e-Diary.~The percentage of days a participant reported any bleeding was calculated as the total number of days the participant reported any bleeding ( light, moderate, or heavy) divided by the total number of days the participant had a non-missing e-Diary report of vaginal bleeding in the phase."|Screening (8 weeks prior to day 1) and the double-blind treatment phase (Weeks 1-8)|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) with non-missing data.|||percentage of days||Standard Error|Mean
2736767|NCT00973973|Secondary|Change From Baseline to the End of the Open-label Treatment Phase in Endometriosis Health Profile-5 (EHP-5)|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the impact of endometriosis on areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)~A supplemental questionnaire consisting of six additional questions which assess the impact of endometriosis on areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.~The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life."|Baseline and week 24|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at baseline and week 24 for each question.|||units on a scale||Standard Error|Mean
2736768|NCT00973973|Secondary|Change From Baseline to the End of the Double-blind Treatment Phase in Endometriosis Health Profile-5 (EHP-5)|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the impact of endometriosis in areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)~A supplemental questionnaire consisting of six additional questions which assess the impact of endometriosis on the areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.~The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life."|Baseline and week 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at baseline and week 8 for each question.|||units on a scale||Standard Error|Mean
2736769|NCT00973973|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Open-label Treatment Phase|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||percentage of participants|||Number
2736770|NCT00973973|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved During the Double-blind Treatment Phase|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2736920|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Aspartate Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736771|NCT00973973|Secondary|Patient Global Impression of Change During the Open-Label and Posttreatment Phases|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2736772|NCT00973973|Secondary|Patient Global Impression of Change During the Double-blind Treatment Phase|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2736773|NCT00973973|Secondary|Change From Baseline to the End of the Open-label Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and non-menstrual pelvic pain scores are based on the participant's assessment of symptoms during the past 28 days; pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning). Individual component scores range from 0 (absent) to 3 (severe)."|Baseline and week 24|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 24. The analysis includes participants with non-missing data for each component at baseline and week 24.|||units on a scale||Standard Error|Mean
2736774|NCT00973973|Secondary|Change From Baseline to the End of the Double-blind Treatment Phase in Composite Pelvic Signs and Symptoms Score (CPSSS) Total Score and Component Scores|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and non-menstrual pelvic pain scores are based on the participant's assessment of symptoms during the past 28 days; pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning). Individual component scores range from 0 (absent) to 3 (severe)."|Baseline and Week 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at baseline and week 8.|||units on a scale||Standard Error|Least Squares Mean
2736775|NCT00973973|Secondary|Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Open-Label and Posttreatment Phases|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit (except for week 30 which is based on 6 weeks of data) that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2736776|NCT00973973|Secondary|Change From Baseline in the Percentage of Days of Narcotic Analgesic Use During the Double-Blind Treatment Phase|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2736777|NCT00973973|Secondary|Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Open-Label and Posttreatment Phases|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit (except for week 30 which is based on 6 weeks of data) that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2736778|NCT00973973|Secondary|Change From Baseline in the Percentage of Days of Prescription Analgesic Use During the Double-Blind Treatment Phase|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2736779|NCT00973973|Secondary|Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit (except for week 30 which is based on 6 weeks of data) that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2736780|NCT00973973|Secondary|Change From Baseline in the Percentage of Days of Any Analgesic Use During the Double-Blind Treatment Phase|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2736781|NCT00973973|Secondary|Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8|"Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options:~0 = Absent; No discomfort during sexual intercourse~1 = Mild; I was able to tolerate the discomfort during sexual intercourse~2 = Moderate; Intercourse was interrupted due to pain~3 = Severe; I avoided intercourse because of pain~Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse~The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each time point.~Response is defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%)."|Baseline and Week 8|"All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8. If a participant's responses were all does not apply for that month the score was treated as missing."|||percentage of participants|||Number
2736782|NCT00973973|Secondary|Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8|"Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time every day in an e-Diary according to the following:~0 = No discomfort~1 = Mild discomfort~2 = Moderate discomfort or pain~3 = Severe pain~The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) in the 4 weeks prior to each time point.~Response is the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%)."|Baseline and Week 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8.|||percentage of participants|||Number
2736783|NCT00973973|Secondary|Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having their period in an e-Diary according to the following response options:~0 = No discomfort~1 = Mild discomfort but I was easily able to do the things I usually do~2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do~3 = Severe pain that made it difficult to do the things I usually do.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each time point.~Response is defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%)."|Baseline and Week 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8.|||percentage of participants|||Number
2736804|NCT00973739|Primary|Estimated Volumetric Progression Free Survival at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of volumetric progression. PFS was analyzed using the Kaplan-Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.~Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan-Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.|||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
2736784|NCT00973973|Secondary|Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each time point.~Response was defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%)."|Baseline and Week 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8.|||percentage of participants|||Number
2736785|NCT00973973|Primary|Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases|"Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options:~0: Absent; No discomfort during sexual intercourse~1: Mild; I was able to tolerate the discomfort during sexual intercourse~2: Moderate; Intercourse was interrupted due to pain~3: Severe; I avoided intercourse because of pain~Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse~The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit, except for week 30 which is based on 6 weeks of data. Responses of does not apply were not included in the calculations."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|"Randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12 and non-missing data at each time point. If a participant's responses were all does not apply for that month the score was treated as missing."|||units on a scale||Standard Error|Mean
2736786|NCT00973973|Primary|Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase|"Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options:~0 = Absent; No discomfort during sexual intercourse~1 = Mild; I was able to tolerate the discomfort during sexual intercourse~2 = Moderate; Intercourse was interrupted due to pain~3 = Severe; I avoided intercourse because of pain~Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse~The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit. Responses of does not apply were not included in the calculations."|Baseline and weeks 4 and 8|"All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at each time point. If a participant's responses were all does not apply for that month the score was treated as missing."|||units on a scale||Standard Error|Least Squares Mean
2736787|NCT00973973|Primary|Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases|"Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following:~0: No discomfort~1: Mild discomfort, I was easily able to do the things I usually do~2: Moderate discomfort or pain making it difficult to do some of the things I usually do~3: Severe pain making it difficult to do the things I usually do~The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2736788|NCT00973973|Primary|Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase|"Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following:~0 = No discomfort~1 = Mild discomfort but I was easily able to do the things I usually do~2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do~3 = Severe pain that made it difficult to do the things I usually do.~The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit."|Baseline and weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2736789|NCT00973973|Primary|Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having their period in an e-Diary according to the following response options:~0 = No discomfort~1 = Mild discomfort but I was easily able to do the things I usually do~2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do~3 = Severe pain that made it difficult to do the things I usually do.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2736805|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).~Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.~The analyses were performed on the safety set."|7 days after each vaccination|The analysis is done on the safety set.|||Number of subjects|||Number
2736790|NCT00973973|Primary|Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having their period in an e-Diary according to the following response options:~0 = No discomfort~1 = Mild discomfort but I was easily able to do the things I usually do~2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do~3 = Severe pain that made it difficult to do the things I usually do.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2736791|NCT00973973|Primary|Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an electronic diary (e-Diary) according to the following response options:~0 = No discomfort~1 = Mild discomfort but I was easily able to do the things I usually do~2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do~3 = Severe pain that made it difficult to do the things I usually do.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data."|Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2736792|NCT00973973|Primary|Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an electronic diary (e-Diary) according to the following response options:~0 = No discomfort~1 = Mild discomfort but I was easily able to do the things I usually do~2 = Moderate discomfort or pain that made it difficult to do some of the things I usually do~3 = Severe pain that made it difficult to do the things I usually do.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4 and 8|All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2736793|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the QCA and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||mm||Standard Deviation|Mean
2736794|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||percentage of correct decision by QCA|||Number
2736795|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||mm||Standard Deviation|Mean
2736796|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On the procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||percentage of correct decisions by SO|||Number
2736797|NCT00973856|Secondary|Change in Size of Warts Treated by Each Product at Each Time Point.|Data is not available due to study closure and data destruction|Baseline, 4, 8 and 12 weeks, change at 12 weeks reported||2020-07-31|07/2020||||
2736798|NCT00973856|Primary|Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint|Data is not available due to study closure and data destruction|Baseline, 4, 8, and 12 weeks, change at 12 weeks reported|Data is not available due to study closure and data destruction||||wart reduction %||
2736799|NCT00973765|Primary|Treatment Failures at 7 Days|worsening abscess or new recurrence of abscess|7 days||||participants|||Number
2736800|NCT00973752|Primary|Overall Survival at One Year|The number of participants alive one year after baseline.|1 years||||Participants|||Count of Participants
2736801|NCT00973739|Secondary|Participants Experiencing Grade 3 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year||||participants|||Number
2736802|NCT00973739|Secondary|Participants Experiencing Grades 1 or 2 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year||||participants|||Number
2736803|NCT00973739|Secondary|Estimated Volumetric Progression Free Survival for Hearing at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of hearing progression. PFS was analyzed using the Kaplan-Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.~Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan-Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.|||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
2736806|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).~Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.~Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination."|7 days after each vaccination|The analysis is done on the safety set.|||Number of subjects|||Number
2736807|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).~Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination"|7 days after each vaccination|The analysis is done on the safety set.|||Number of subjects|||Number
2736808|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the per-protocol set (PPS)."|7 days and 21 days after each vaccination|The analysis is done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
2736809|NCT00973700|Secondary|HI GMR, in Adults 18 to 64 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.|||Ratio||95% Confidence Interval|Geometric Mean
2736810|NCT00973700|Secondary|HI GMRs, in 3 to <9 Years and 9 to 17 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).~The analyses were performed on the the per-protocol set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.|||Ratio||95% Confidence Interval|Geometric Mean
2736811|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
2736812|NCT00973700|Secondary|Age Distribution at Baseline||Baseline|The overall number of baseline participants.|||years||Standard Deviation|Mean
2736813|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~Analyses were performed on the Per-Protocol set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
2736814|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
2736815|NCT00973674|Secondary|Acute Respiratory Distress Syndrome (ARDS) Free Survival|ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score indicates better prognosis.|Days 0-28||||days||Standard Deviation|Mean
2736816|NCT00973674|Secondary|6-month Glasgow Outcomes Scale- Extended (GOSE) Score|The GOSE is a scale for functional outcome following a severe traumatic injury. The GOSE is an ordinal variable with the following categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery. The GOSE score is determined by a structured interview with questions surrounding consciousness, independence inside and outside the home, social and leisure activities and return to normal life among others. A higher score is considered to be a better result. A lower score indicates a worse result. The scale is 1-8, level 1 minimum score, level 8 maximum score.|Up to 6 months post-injury|The study specifically measures long-term GOSE, defined as post 6 months. Six month follow-up were not available for all patients and thus the lower sample size. As a secondary measure, missing values were not imputed.|||units on a scale||Standard Deviation|Mean
2736817|NCT00973674|Secondary|28-day Mortality|Mortality is defined as the number of patients who died prior to 28 days post injury. Patients who are still in the hospital 28-days post injury are considered alive. The trial examines the rate of enrolled patients on each arm who died prior to 28 days post injury.|28 Days||||participants|||Number
2736818|NCT00973674|Primary|Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury|The GOAT is a measure of early cognitive recovery following a severe traumatic injury. The score is determined after examination by health professionals with respect to orientation to person, place and time. On a scale 0 to 100, 76-100 represents normal recovery. The trial measures the percentage of patients who pass the Galveston Orientation Amnesia Test (GOAT) within 28 days post injury.|28 Days||||Participants|||Count of Participants
2736819|NCT00973622|Primary|A Difference Score for the Log Value of K.|K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.|baseline and immediately after stimulation, an average of 25 seconds.|All participants that attended at least one session and provided at least some outcome data were included in the analyses|||log transformed values of K||Standard Deviation|Log Mean
2736820|NCT00973479|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.|Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Scores on a scale||Standard Deviation|Mean
2736821|NCT00973479|Secondary|Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Percentage of Participants|||Number
2736822|NCT00973479|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Scores on a scale||Standard Deviation|Mean
2736823|NCT00973479|Secondary|Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14|"DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant's global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score >1.2 is being referred to as a good response and a decrease of 0.6-1.2 as a moderate response."|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Percentage of Participants|||Number
2736824|NCT00973479|Primary|Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 [no pain] to 10 [worst pain]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Percentage of Participants|||Number
2736825|NCT00973362|Secondary|ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)|ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay|Baseline Evaluation|74 women with Aptima HPV assay results did not have FDA-Approved HPV DNA test results primarily due to insufficient volume of the cytology specimen for an N of 865 results for the FDA-Approved HPV DNA assay compared to 939 results for the Aptima HPV assay.|||participants|||Number
2736826|NCT00973362|Secondary|ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)|ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)|Baseline Evaluation||||participants|||Number
2736827|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation|18 women with Aptima HPV results did not have FDA-Approved DNA test results due to insufficient volume of the cytology specimen for a N of 801 compared to a N of 819 for the Aptima HPV assay results.|||participants|||Number
2736828|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation||||participants|||Number
2736829|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.|||Participants|||Number
2736830|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.|||Participants|||Number
2736831|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.|||Participants|||Number
2736832|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The population used in analysis was the safety set|||Participants|||Number
2736833|NCT00973349|Secondary|Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.|21 days after vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.|||Geometric Mean Ratio||95% Confidence Interval|Geometric Mean
2736834|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.|||Participants|||Number
2736835|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age|Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.|||Participants|||Number
2736836|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.|||Participants|||Number
2736837|NCT00973349|Secondary|Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age|Geometric mean hemagglutinin inhibition (HI) titer = GMT|21 days after each vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.|||Geometric Mean Titer||95% Confidence Interval|Geometric Mean
2736838|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age|Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was based on the per protocol population.|||Participants|||Number
2736839|NCT00973102|Secondary|Acute Respiratory Distress Syndrome (ARDS) Free Survival|ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is >10-14 days.|28 days||||units on a scale||Standard Deviation|Mean
2736840|NCT00973102|Primary|Survival|Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.|28 Days||||participants|||Number
2736841|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): bone formation marker [bone-specific alkaline phosphatase (bALP) ].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||U/L||Full Range|Median
2736842|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA) bone formation marker [bone-specific alkaline phosphatase (bALP)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||U/L||Full Range|Median
2736843|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery) after 18 months post VD|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
2736844|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related events (SRE: pathologic fractures, need for bone radiation therapy or surgery) following 8 cycles (day 168) of therapy|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
2736845|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] every 6 months for up to 18 months|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
2736921|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Calcium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736846|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
2736847|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 8 (day 168).~Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The VAS for Bone Pain was constructed as follows:~None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||units on a scale||Full Range|Median
2736848|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 4 (day 84).~Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The VAS for Bone Pain was constructed as follows:~None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||units on a scale||Full Range|Median
2736849|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 8 (day 168) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker [osteocalcin (OC)].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||ng/ml||Full Range|Median
2736850|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation markers [osteocalcin (OC)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||ng/ml||Full Range|Median
2736851|NCT00972959|Secondary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||T-score||Full Range|Median
2736852|NCT00972959|Primary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by dual energy X-ray absorptiometry (DXA) using a Hologic QDR-1000 scanner on day 21 of cycle 4 (day 84)|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||T-scores||Full Range|Median
2736853|NCT00972816|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AEs)|Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)|Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination|The analysis was done on unsolicited safety set population.|||Subjects|||Number
2736854|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination|Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)|7 days after second vaccination|The analysis was performed on safety set population|||Participant|||Number
2736855|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination|Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).|7 days after first vaccination|The analysis was performed on safety set population|||Participants|||Number
2736856|NCT00972816|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.~Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10)."|Day 1, Day 22, Day 29, Day 43||||Titers||95% Confidence Interval|Geometric Mean
2736857|NCT00972816|Secondary|Antibody Response Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.~Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.~Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29 and Day 43||||percentage of Subjects||95% Confidence Interval|Number
2736916|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - C Reactive Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736858|NCT00972816|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|"Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines~Subgroups without recent seasonal flu vaccine:~PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.~Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.~PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively"|Day 1, Day 22, Day 29, Day 43|The analysis was done on PPS population.|||Titers||95% Confidence Interval|Geometric Mean
2736859|NCT00972816|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.|HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.|Day 22, Day 29, Day 43|The analysis was done on PPS population|||percentage of Subjects||95% Confidence Interval|Number
2736860|NCT00972816|Secondary|Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group|"Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.~PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population|||Titers||95% Confidence Interval|Geometric Mean
2736861|NCT00972816|Primary|Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations|"HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.~PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.~PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population|||percentage of subjects||95% Confidence Interval|Number
2736862|NCT00972777|Secondary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 3|Microbial Eradication at Visit 3, (LOCF), mITT Population.|||eyes|||Number
2736863|NCT00972777|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 3|Clinical Resolution at Visit 3, (LOCF) mITT Population.|||eyes|||Number
2736864|NCT00972777|Primary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 2|Microbial Eradication at Visit 2, (LOCF), mITT Population.|||eyes|||Number
2736865|NCT00972777|Primary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 2|Clinical Resolution at Visit 2, (LOCF), mITT Population.|||eyes|||Number
2736866|NCT00972738|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period|Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.|Baseline and at the end of 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and a week 2 measurement were included. No missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736867|NCT00972738|Secondary|Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736868|NCT00972738|Secondary|Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736917|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736869|NCT00972738|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736870|NCT00972738|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736871|NCT00972738|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2736872|NCT00972725|Secondary|Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mEL.U/mL||95% Confidence Interval|Geometric Mean
2736873|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736874|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736875|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736876|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736877|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736878|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736879|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2750735|NCT00870870|Secondary|Cmax of Cixutumumab for Cycle 1||Week 1 (Cycle 1, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2736880|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736881|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736882|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736883|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736884|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736885|NCT00972725|Secondary|Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines|Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736886|NCT00972725|Secondary|Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens|Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2736887|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736888|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736889|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736890|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736918|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736891|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736892|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736893|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736894|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736895|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736896|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736897|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736898|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736899|NCT00972725|Secondary|Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2736900|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.|At Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736901|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736902|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736903|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736904|NCT00972725|Primary|Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)|Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.|During the entire study period (from Day 0 up to Day 360)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736905|NCT00972725|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 360)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736906|NCT00972725|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736907|NCT00972725|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7 Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736908|NCT00972725|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7 Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2736909|NCT00972725|Primary|Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens|Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).|At Day 14|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2736910|NCT00972621|Secondary|Postoperative Mean Endothelial Cell Count|mean endothelial cell count (measured by Konan specular microscope) at 3 months|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting mean endothelial cell count for ITT population, which differs from the safety population used in the Participant Flow.|||number of endothelial cells||Standard Deviation|Mean
2736911|NCT00972621|Primary|Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively|Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow.|||percentage of participants||90% Confidence Interval|Number
2736912|NCT00972595|Primary|Peak Plasma Concentration (Cmax) for Ondansetron||24 hours post-dose|All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.|||ng/mL||Standard Deviation|Least Squares Mean
2736913|NCT00972595|Primary|Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose|All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Least Squares Mean
2736914|NCT00972543|Secondary|Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)||||participants|||Number
2736915|NCT00972543|Secondary|Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)||||participants|||Number
2736925|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Urea|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736926|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Potassium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736927|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Sodium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736928|NCT00972543|Secondary|Haematology Laboratory Assessments - Basophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736929|NCT00972543|Secondary|Haematology Laboratory Assessments - Eosinophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736930|NCT00972543|Secondary|Haematology Laboratory Assessments - Monocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736931|NCT00972543|Secondary|Haematology Laboratory Assessments - Lymphocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736932|NCT00972543|Secondary|Haematology Laboratory Assessments - Neutrophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736933|NCT00972543|Secondary|Haematology Laboratory Assessments - Platelets|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736934|NCT00972543|Secondary|Haematology Laboratory Assessments - White Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736935|NCT00972543|Secondary|Haematology Laboratory Assessments - Red Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736936|NCT00972543|Secondary|Haematology Laboratory Assessments - Haematocrit|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736937|NCT00972543|Secondary|Haematology Laboratory Assessments - Haemoglobin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
2736938|NCT00972543|Secondary|Weight Measurements||Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
2736939|NCT00972543|Secondary|Temperature||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study||||||
2736940|NCT00972543|Secondary|Arterial Blood Pressure||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study||||||
2736941|NCT00972543|Secondary|Heart Rate||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study||||||
2736942|NCT00972543|Secondary|Complaint Directed Physical Examinations|Number of participants undergoing complaint directed physical examinations|Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)|Results not analysed due to early termination of the study||||||
2736943|NCT00972543|Secondary|Participants With Direct Physical Examination Abnormalities|Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum|Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits|Results not analysed due to early termination of the study||||||
2736944|NCT00972543|Primary|Dynamic Physician's Global Assessment of Change (dPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
2736945|NCT00972543|Primary|Static Physician Global Assessment (SPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Screening, Day 0 and Day 7|Results not analysed due to early termination of the study||||||
2736946|NCT00972543|Primary|Psoriasis Area and Severity Index (PASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
2736949|NCT00972530|Primary|Relapse of Arthritis|The patients were followed for six months and if signs and symptoms recurred in between the patients were told to contact the rheumatology department. In such cases the elbow was re-examined and if a relapse could be confirmed the duration of effect was recorded and if needed the patient was offered another injection.|Regular visits at one week, 3 months and 6 months.||||participants|||Number
2736950|NCT00972517|Secondary|Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)|Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.|At Day 0, Day 21, Day 42 and Month 6 (M6)|The Total Vaccinated cohort including all vaccinated subjects with data available for the respective assays at the considered timepoints. Note that for Flu BS2 Groups, no blood samples were taken at Day 0 and Day 21 and hence no data for these timepoints are reported for the Flu BS2 Groups.|||Participants|||Count of Participants
2736951|NCT00972517|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 to Month 12)|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2736952|NCT00972517|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2736953|NCT00972517|Secondary|Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. Any pIMD was defined as at least one pIMD experienced by the study subject."|During the entire study period (Day 0 to Month 12)|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2736954|NCT00972517|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.|During the entire study period (Day 0 to Month 12)|The Total Vaccinated cohort included all vaccinated subjects.|||Participants|||Count of Participants
2736955|NCT00972517|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet.|||Participants|||Count of Participants
2736956|NCT00972517|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet.|||Participants|||Count of Participants
2736957|NCT00972517|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.|At Month 6|The ATP cohort for antibody persistence at Month 6 including subjects with assay results available for Day 0, Day 21 and Month 6. As no pre-vaccination (Day 0/21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was done on a randomly selected subset of a third of the subjects.|||Participants|||Count of Participants
2736958|NCT00972517|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.|At Day 21 and Day 42|The ATP cohort for immunogenicity including subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was conducted on a randomly selected subset of one third of the subjects.|||Participants|||Count of Participants
2736959|NCT00972517|Secondary|Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs).|At Month 12|The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at Month 12. No blood samples were planned at Month 12 the Flu BS1 Groups and hence no GMTs computed for these Groups. This analysis was conducted on a randomly selected subset of one third of the subjects.|||Titers||95% Confidence Interval|Geometric Mean
2736960|NCT00972517|Secondary|Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 0, Day 21, Day 42 and Month 6|The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at the considered time points. No blood samples were taken at Day 0 and Day 21 and hence no GMTs computed for the Flu BS2 Groups. This analysis was conducted on a randomly selected subset of one third of the subjects.|||Titers||95% Confidence Interval|Geometric Mean
2736961|NCT00972517|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years|At Month 6|The ATP cohort for antibody persistence at Month 6 including all subjects for whom assay results were available for antibodies against the study vaccine antigen component pre-vaccination (Day 0 and Day 21) and at Month 6. As no pre-vaccination blood samples were planned for the Flu BS2 Groups, GMFR at Month 6 could not be computed for those groups.|||Fold change||95% Confidence Interval|Geometric Mean
2736962|NCT00972517|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.|At Month 12|The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, no data were computed for these groups.|||Participants|||Count of Participants
2736963|NCT00972517|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.|At Month 6|The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
2736964|NCT00972517|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.|At Month 6|The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available at pre-vaccination time points (Day 0 and Day 21) and post-vaccination time point (Month 6). No pre-vaccination blood samples were taken from Flu BS2 Groups and hence seroconversion could not be assessed for these groups.|||Participants|||Count of Participants
2736965|NCT00972517|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain|Antibody titers were expressed as geometric mean titers (GMTs)|At Month 12|The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, GMTs could not be computed for those groups.|||Titers||95% Confidence Interval|Geometric Mean
2736966|NCT00972517|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain|Antibody titers were expressed as geometric mean titers (GMTs)|At Month 6|The ATP cohort for antibody persistence at Month 6 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for antibodies against the study vaccine antigen component at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2736967|NCT00972517|Primary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years|At Day 42|This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, GMFR at Day 42 could not be computed for those groups.|||Fold change||95% Confidence Interval|Geometric Mean
2736968|NCT00972517|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.|At Day 42|The ATP cohort for immunogenicity included all evaluable subjects for whom 2 doses were administrated and assay results were available for antibodies against H1N1 antigen for the blood sample taken after the second vaccine dose (Day 42).|||Participants|||Count of Participants
2737017|NCT00971997|Secondary|Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48||Baseline and Weeks 16, 32 and 48|Participants who completed treatment through Week 48.|||units of insulin/day||Standard Deviation|Mean
2736969|NCT00972517|Primary|Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.|At Day 42|This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion at Day 42 could not be computed for those groups.|||Participants|||Count of Participants
2736970|NCT00972517|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 0, Day 21 and Day 42|The ATP cohort for immunogenicity included all subjects for whom 2 doses were administrated and assay results were available for the blood samples taken before the first vaccination (Day 0), before the second vaccination (Day 21) and after the second vaccine dose (Day 42). No blood samples were planned at Day 0 and Day 21 for Flu BS2 Groups.|||Titers||95% Confidence Interval|Geometric Mean
2736971|NCT00972504|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or is associated with liver injury and impaired liver function defined as: alanine aminotransferase >=3 times upper limit of normal (ULN), and total bilirubin >=2 times ULN or international normalized ratio more than 1.5.|approximately up to 63 days|All Subjects population.|||Participants|||Number
2736972|NCT00972504|Secondary|Mean Forced Expiratory Volume in 1 Second (FEV1)|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Liters||Standard Deviation|Mean
2736973|NCT00972504|Secondary|Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2736974|NCT00972504|Secondary|Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Grams||95% Confidence Interval|Least Squares Mean
2736975|NCT00972504|Secondary|Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2736976|NCT00972504|Primary|Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|The all subjects population was used defined as all participants who receive at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2750736|NCT00870870|Secondary|Maximum Concentration (Cmax) of Cixutumumab at Study Day 1||Day 1|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2736977|NCT00972478|Secondary|Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to week 26|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2736978|NCT00972478|Secondary|Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to week 26|Eligible patients who received the protocol treatment in the Phase II portion of the study|||percentage of participants||95% Confidence Interval|Number
2736979|NCT00972478|Secondary|Overall Survival (Phase II)|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.|||percentage of participants||95% Confidence Interval|Number
2736980|NCT00972478|Primary|Progression-free Survival (Phase II)|From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.|||percentage of participants||95% Confidence Interval|Number
2736981|NCT00972478|Primary|Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)|Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|21 days|Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).|||mg PO Once daily Days 1-9|||Number
2736982|NCT00972439|Primary|Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups|Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells|32 weeks|Five of the breast biopsy specimens contained insufficient TDLU epithelial tissue for analysis and one of the remaining women was diagnosed with a follicular cyst on the day of the biopsy, leaving 27 evaluable women.|||Percent of cells staining for Ki67||95% Confidence Interval|Mean
2736983|NCT00972374|Other Pre-specified|Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit|IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.|12 Months|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2736984|NCT00972374|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 3|Intent to Treat: all randomized patients|||Number of Letters Read Correctly||Standard Deviation|Mean
2736985|NCT00972374|Primary|Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.|Month 3|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2736986|NCT00972335|Secondary|To Correlate the Activity of This Treatment Regimen With Expression of Selected Intra-tumoral Biomarkers.||18 months|||||||
2736987|NCT00972335|Secondary|To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.||18 months|Includes all treated patients (one patient not treated)|||participants|||Number
2736988|NCT00972335|Primary|Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.|18 months|Includes all enrolled and treated patients (one patient not treated)|||months||95% Confidence Interval|Median
2736989|NCT00972322|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Day 28|All participants who received at least one dose of the investigational drug.|||Participants|||Number
2736990|NCT00972322|Primary|Number of Participants Who Experienced Serious or Non-serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to Day 31|All participants who received at least one dose of the investigational drug.|||Participants|||Number
2751645|NCT00863265|Primary|Cholesterol Excretion|Milligrams of fecal cholesterol and cholesterol metabolites excreted per day|At the end of week 3 on each diet|Healthy subjects|||mg per day||95% Confidence Interval|Mean
2736991|NCT00972322|Primary|Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose."|Baseline and Day 28|All participants who were compliant with the study procedures and have available data from at least one treatment were included in the primary analysis dataset.|||mg/dL||Standard Deviation|Least Squares Mean
2736992|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2736993|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2736994|NCT00972283|Primary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2736995|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2736996|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 78 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
2736997|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78|Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast.|Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2736998|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
2736999|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment|Change from baseline in HbA1c after 78 weeks of treatment|Week 0, Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2737000|NCT00972283|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF)|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2737001|NCT00972244|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy|At Week 12|Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values|||Percentage of participants|||Number
2737002|NCT00972244|Secondary|Adjusted Mean Change in Fasting Plasma Glucose|Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2737003|NCT00972244|Primary|Adjusted Mean Change in HbA1c Levels|The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values|||percent||95% Confidence Interval|Least Squares Mean
2737004|NCT00972205|Secondary|Number of Participants Who Had an Overall Response|"Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.~See the Protocol Link module for further details about the RECIST Criteria."|Baseline to progression||||participants with response|||Number
2737005|NCT00972205|Secondary|Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment|Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms.|Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.|Rhodamine 123 fluorescence was assessed in CD56+cells after a 30 min loading period with or without exogenously added valspodar and a 60 min efflux period followed, continuing the cells with or without exogenous valspodar to generate Efflux and PSC/Efflux histograms. Percent decrease in difference between these histograms is reported.|||Percent inhibition of rhodamine efflux||Full Range|Mean
2737006|NCT00972205|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months||||Participants|||Number
2737007|NCT00972205|Primary|Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition|An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: [(AUCpost - AUC baseline)/(AUC baseline)] x 100.|sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration|As planned imaging data from 10 pts were analyzed.|||percent increase sestamibi retention||Full Range|Median
2737008|NCT00972153|Secondary|Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter|Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.|Ten minute intervals throughout surgery||||>10 micrometer particles / cubic meter||Full Range|Median
2737009|NCT00972153|Primary|Surgery Site CFU Density|"Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol slit sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter."|Ten minute intervals throughout surgery|Airborne CFU densities were obtained in ten-minute intervals throughout each procedure. Average surgery duration was 69 minutes in the control and sham groups; 66 minutes in the experiment group. A total of 208 density readings were obtained.|||CFU/cubic meter||Full Range|Median
2737010|NCT00972088|Primary|Prevalence of Inflammation as Diagnosed by Capsule Endoscopy|The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.|up to 7 days|per protocol|||participants|||Number
2737011|NCT00972023|Secondary|Toxicity||Within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
2737012|NCT00972023|Secondary|Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
2737013|NCT00972023|Secondary|Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
2737014|NCT00972023|Primary|Tumor Proliferation (Percentage of Ki-67 Positive Cells)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
2737015|NCT00971997|Secondary|Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48|A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.|||number of hypoglycemic episodes|||Number
2737016|NCT00971997|Secondary|Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48|Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.|||percentage of participants|||Number
2737020|NCT00971997|Secondary|Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint|C-peptide is a protein that is produced in the body along with insulin.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2737021|NCT00971997|Secondary|Change From Baseline in Blood Glucose Profile at Week 48 Endpoint|Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||mg/dL||Standard Deviation|Mean
2737022|NCT00971997|Secondary|Change From Baseline in Fasting Glucose at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2737023|NCT00971997|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2737024|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.|Week 48|Participants completed treatment through Week 48.|||percentage of participants||95% Confidence Interval|Number
2737025|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.|Week 16 and Week 32 and Week 48|Participants received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2737026|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 16 and Week 32|Participants received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2737027|NCT00971997|Primary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 48|Participants received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2737028|NCT00971932|Secondary|Time to Treatment Failure|Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.|Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|"ITT population included all participants who received at least one dose of the study medication. Here number of participants analyzed N is signifying those participants for whom trial treatment failed."|||months||95% Confidence Interval|Median
2737029|NCT00971932|Secondary|Overall Survival (OS) Time|Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||months||95% Confidence Interval|Median
2737030|NCT00971932|Secondary|Progression-Free Survival (PFS) Time|The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||months||95% Confidence Interval|Median
2737031|NCT00971932|Secondary|Duration of Response|Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).|Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|Subgroup of participants from the study population with a best overall response (CR or PR).|||months||95% Confidence Interval|Median
2737063|NCT00971620|Primary|Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory|Change in worst lesional pain in the past week based on Brief Pain Inventory (BPI) from Week 0 to Week 4 in treated patients versus controls. The BPI uses an arbitrary units on a 0-10 scale. For the purposes of the statistical calculation, a difference of 1 standard deviation between groups at baseline vs. week 4 was considered significant. Any BPI value above zero (no pain) is abnormal. The mean change indicates mean change in pain score.|Between week 0 and week 4||||units on a scale||Standard Error|Mean
2737032|NCT00971932|Secondary|Disease Control Rate|Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (>=50 percent decrease in sum of the products of diameters [SOPD] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease [SD] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
2737033|NCT00971932|Secondary|Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
2737034|NCT00971932|Primary|Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria|Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).|Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011|Intention-to-treat (ITT) population included all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
2737035|NCT00971841|Secondary|Number of Participants With Complete Response to Tumor|Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).|Every 7 weeks Day 1 to 4 years|Only one participant enrolled so results are for one participant.|||participants|||Number
2737036|NCT00971841|Primary|Number of Adverse Events (AEs) Per Participant|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.|Weekly Day 1 to 4 years|Only one participant enrolled in the study so all results represent one participant.|||adverse events|||Number
2737037|NCT00971789|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events|47 months||||Participants|||Number
2737038|NCT00971789|Primary|Biochemical Changes in Benign and Malignant Tumor Tissues as Assessed by Immunohistochemistry.|A biochemical change is defined as a decrease in certain protein levels (e.g. P-AKT (phosphorylated AKT), total S6, P-S6, and P-4E-BP1) important in cell growth. These are measured by collecting tissue samples which stained and protein levels are measured under the microscope. Scoring will be based on distribution and intensity of staining. Distribution will be scored as 0 (0%), 1 (1% to 50%), and 2 (51% to 100%) to indicate the percentage of positive cells of interest in a single core. The intensity of the signal will be scored as 1 (weak), 2 (moderate), and 3 (strong). The distribution score and intensity score will be summed into a total score (TS).|Baseline, day 14, and day 56|No patient underwent biopsy after the study treatment, so no such tissue analysis was done.||||||
2737039|NCT00971750|Primary|Polyps on Transabdominal and Laparoscopic Ultrasound|Number of patients with polyps.|6 years||||participants|||Number
2737040|NCT00971750|Secondary|Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Mean CBD diameter.|transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively||||millimeters||Standard Deviation|Mean
2737041|NCT00971750|Primary|Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Number of patients with cholelithiasis.|transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively||||participants|||Number
2737042|NCT00971737|Secondary|Characterization of the T-cell Memory Pool Pre- and Post-vaccination||3 years|Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure.||||||
2737043|NCT00971737|Secondary|Enumeration of CD8+ T Cells Specific for hTERT by ELISPOT||3 years|Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure.||||||
2737044|NCT00971737|Secondary|Immune Priming in In-vivo Vaccine-site Biopsies||3 years|Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure||||||
2737045|NCT00971737|Primary|Pharmacodynamics of Peripheral CD4+CD25+ Regulatory T Cells||3 years|Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure.||||||
2737046|NCT00971737|Primary|HER-2/Neu-specific Immune Responses as Measured by Number of Participants With Positive for Delayed-type Hypersensitivity (DTH) Response||3 years|Data was not evaluable in 2/30 participants from the cyclophosphamide and vaccine-only arm.|||Participants|||Count of Participants
2737064|NCT00971425|Secondary|Number of Subjects With AEs of Specific Interest|Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737047|NCT00971737|Primary|Clinical Benefit (CB) as Assessed by Progression Free Survival at Six Months|Progression-free survival is measured as percentage of participants with stable disease or complete response, as defined by RECIST criteria, six months after receiving last vaccination. Progressive disease (PD) will be defined by the appearance of a new lesion, or by an increase of at least 20% in the sum of the longest diameter of target lesions, taking as a reference that smallest sum longest diameter recorded since the study intervention began. In the case of bone lesions, progressive disease will be established after eight weeks of increasing or new lesions if there is subjective progressive disease as noted by increasing bone pain or decreasing performance status. These observations must be present for at least two measurement periods separated by at least four weeks.|6 months post-intervention|Data was not evaluable in 2/30 participants from the cyclophosphamide and vaccine-only arm.|||percentage of participants||95% Confidence Interval|Number
2737048|NCT00971737|Primary|Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events|Number of grade 3 or 4 nonhematologic toxicity (except alopecia), or any grade 4 hematologic toxicity as defined by NCI CTCAE v3.0|3 years|Data was not evaluable in 2/30 participants from the cyclophosphamide and vaccine-only arm.|||adverse events|||Number
2737049|NCT00971633|Primary|Maximum Plasma Concentration (Cmax) of Ondansetron||24 hours post dose|All study participants (N=12)|||nM||Standard Deviation|Least Squares Mean
2737050|NCT00971633|Primary|Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose|All study participants (N=12)|||nM*hr||Standard Deviation|Least Squares Mean
2737051|NCT00971620|Secondary|Worst Pain Severity|Pain severity was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)). This outcome was based on a single 0-10 question on the BPI.|Week 0 vs. week 4||||Score||Full Range|Median
2737052|NCT00971620|Secondary|Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 = worse pain.|Week 0 vs. week 4||||percentage of patients|||Number
2737053|NCT00971620|Secondary|Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale of 0-10. 10 = worse pain.|Week 0 vs. week 4||||percentage of patients|||Number
2737054|NCT00971620|Secondary|Percentage of Patients With a Change in Average Pain Score|Average pain was determined from a 0-10 scale question on the Brief Pain Inventory (BPI). 10 denotes worse pain.|Week 0 score vs. week 4 score||||percentage of patients|||Number
2737055|NCT00971620|Secondary|Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration|c-fos, a marker of neuronal activation after pain stimulation, was scored as 0 (none), 1 (scattered), 2 (<66% of tumor cells), or 3 (≥66% of tumor cells).|Week 0 vs. week 12||||Score||Full Range|Median
2737056|NCT00971620|Secondary|Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration|AchE staining was scored as 0 (none), 1 (rare), 2 (scattered), or 3 (focal or greater).|Week 0 vs. week 12||||Score||Full Range|Median
2737057|NCT00971620|Secondary|Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 denotes worse pain than 0.|Between week 12 and 24||||Score||Full Range|Median
2737058|NCT00971620|Secondary|Specific Skin Pain-Related Question on the Dermatology Life Quality Index|"The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Participants response to the question Over the last week, how itchy, sore, painful or stinging has your skin been? was assessed by the Dermatology Life Quality Index. This outcome refers to a single specific question on the DLQI, so the range for this outcome is 0-3. Lower values in the DLQI indicate less impairment (or greater improvement) in life quality from the skin disease."|Week 0 vs. week 4||||Units on a scale||Full Range|Median
2737059|NCT00971620|Secondary|Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4|The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Score is 0-30 based on 10 questions. The higher the score, the more quality of life is impaired.|Week 0 vs. week 4||||Units on a scale||Full Range|Median
2737060|NCT00971620|Secondary|Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4|The VAS is a commonly used validated tool for assessment of pain. For this measure, a 10-cm VAS was used to assess current patient pain/discomfort before application of ice to study lesions at week 0 and week 4. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Range is 0-10; 0 is no pain and 10 is worst possible pain.|Week 0 vs. week 4||||Score||Full Range|Median
2737061|NCT00971620|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|37 months||||participants|||Number
2737062|NCT00971620|Primary|Median Change in Average Pain Between Two Arms|Change in average pain was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)).|Between weeks 0 and week 4||||Score||Full Range|Median
2737065|NCT00971425|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737066|NCT00971425|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination"|During 21 days (Day 0-20) after each vaccination|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737067|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix|Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)|During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix|The analysis was performed on the Total Vaccinated cohort on subjects with available results.|||subjects|||Number
2737068|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix|Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).|During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix|The analysis was performed on the Total Vaccinated cohort on subjects with available results|||subjects|||Number
2737069|NCT00971425|Secondary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.~Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
2737070|NCT00971425|Secondary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"For the definition of seroconversion factor, please refer to the primary outcome measure.~Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||fold increase||95% Confidence Interval|Mean
2737071|NCT00971425|Secondary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
2737072|NCT00971425|Secondary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"The cut-off was a titer of 1:10 and this titer was considered as seropositivity.~Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
2737073|NCT00971425|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||titer||95% Confidence Interval|Geometric Mean
2737074|NCT00971425|Primary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
2737075|NCT00971425|Primary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain|"Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0).~The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||fold increase||95% Confidence Interval|Mean
2737076|NCT00971425|Primary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
2737077|NCT00971425|Primary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~The cut-off was a titer of 1:10 and this titer was considered as seropositivity."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
2737078|NCT00971425|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain|"Titers were expressed as GMTs.~The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||titer||95% Confidence Interval|Geometric Mean
2737079|NCT00971321|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 up to Month 11-12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737080|NCT00971321|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737081|NCT00971321|Secondary|Number of Subjects With Normal/Abnormal Biochemical Levels|Among biochemical parameters assessed were: alanine aminotrasferase [ALAT], aspartate aminotransferase [ASAT], bilirubin total [BIL/T], bilirubin direct [BIL/D], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.|At Days 0, 21 and 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737082|NCT00971321|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (Day 0 up to Month 11-12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737083|NCT00971321|Secondary|Number of Subjects With Any Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737084|NCT00971321|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who has their symptom sheets filled in.|||Participants|||Count of Participants
2737085|NCT00971321|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had their symptom sheets filled in.|||Participants|||Count of Participants
2737086|NCT00971321|Secondary|Number of Subjects With Vaccine Response for Serum Neutralising Antibodies|Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.|At Days 21, 42 and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Participants|||Count of Participants
2744162|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||pg/ml||Standard Deviation|Mean
2737087|NCT00971321|Secondary|Number of Subjects With Vaccine Response for Serum Neutralising Antibodies|Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.|At Days 21 and 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Participants|||Count of Participants
2737088|NCT00971321|Secondary|Titers for Serum Neutralising Antibodies|Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.|At Days 0, 21, 42 and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Titers||95% Confidence Interval|Geometric Mean
2737089|NCT00971321|Secondary|Titers for Serum Neutralising Antibodies|Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Titers||95% Confidence Interval|Geometric Mean
2737090|NCT00971321|Secondary|Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers|Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).|At Days 21, 42 and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Fold change||95% Confidence Interval|Geometric Mean
2737091|NCT00971321|Secondary|Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies|Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).|At Days 0, 21, 42 and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Participants|||Count of Participants
2737092|NCT00971321|Secondary|Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers|Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).|At Days 21, 42 and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Participants|||Count of Participants
2737093|NCT00971321|Secondary|Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies|Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).|At Days 0, 21, 42 and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Titers||95% Confidence Interval|Geometric Mean
2737094|NCT00971321|Secondary|Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies|Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).|At Days 0, 21, 42, and at Month 11-12|The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.|||Participants|||Count of Participants
2737095|NCT00971321|Primary|Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers|Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Fold change||95% Confidence Interval|Geometric Mean
2737096|NCT00971321|Primary|Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies|Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Participants|||Count of Participants
2737268|NCT00969540|Secondary|Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Minutes||Standard Deviation|Mean
2737097|NCT00971321|Primary|Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies|Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Participants|||Count of Participants
2737098|NCT00971321|Primary|Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies|Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Titers||95% Confidence Interval|Geometric Mean
2737099|NCT00971321|Primary|Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies|Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjeects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Titers||95% Confidence Interval|Geometric Mean
2737100|NCT00971321|Primary|Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies|Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Participants|||Count of Participants
2737101|NCT00971321|Primary|Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies|Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.|||Participants|||Count of Participants
2737102|NCT00971295|Secondary|AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity|area under the plasma metformin concentration from time zero to infinity|3 weeks||||ng*h/mL||Standard Deviation|Mean
2737103|NCT00971295|Secondary|Tmax - Time of Occurrence of Cmax|time of occurrence of maximum observed plasma metformin concentration|3 weeks||||hours||Standard Deviation|Mean
2737104|NCT00971295|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum Observed Plasma Metformin Concentration|3 weeks||||ng/mL||Standard Deviation|Mean
2737105|NCT00971282|Primary|Pruritus|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
2737106|NCT00971282|Primary|Stinging/Burning|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
2737107|NCT00971282|Primary|Dryness|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
2737108|NCT00971282|Primary|Scaling|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
2737109|NCT00971282|Primary|Erythema Rating Scale|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
2737110|NCT00971243|Secondary|Adverse Events, Laboratory Tests, Vital Signs, Etc.||Weeks 24, 52|||||||
2737111|NCT00971243|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.|Baseline and Week 24|LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.|||mg/dL||Standard Error|Least Squares Mean
2737112|NCT00971243|Primary|Change in HbA1c From Baseline to Week 24|The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.|Baseline and Week 24|LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.|||percentage of HbA1c||Standard Error|Least Squares Mean
2737113|NCT00971204|Primary|Freedom From Recurrence of Atrial Fibrillation|Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.|12 months|Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.|||successful participants|||Number
2737114|NCT00971048|Secondary|Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|At every visit: Day 8, Day 15, Day 22, Day 29||||BWAT-m Exudate Score||Standard Error|Least Squares Mean
2737115|NCT00971048|Secondary|Pain Assessed by a 100-mm VAS Scale.|100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)|At every visit: Day 8, Day 15, Day 22, Day 29|Intent-to-Treat|||VAS Pain Scores||Standard Error|Least Squares Mean
2737116|NCT00971048|Secondary|Number of Participants With Wound Closure by Day 22.||22 days||||Subjects|||Number
2737282|NCT00969332|Secondary|Markers of Sterol Metabolism|Serum Phytosterols - stigmasterol|24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)||||mg/dL||Standard Deviation|Mean
2737283|NCT00969332|Secondary|Markers of Inflammation|Serum Cytokines - interleukin-8|24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)||||pg/mL||Standard Deviation|Mean
2737117|NCT00971048|Primary|Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|22 - 29 days|Intent-to-Treat|||units on a scale||Standard Error|Least Squares Mean
2737118|NCT00970944|Primary|Disability Rating Scale: Functional Status|"Measure of function after traumatic brain injury (TBI) intended to measure function from coma to community. Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability)."|Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6.|Analyses were conducted according to the intention-to-treat principle. 184 subjects were randomized and included for analysis. Since missing data were infrequent and unrelated to the study outcome, imputation methods were not undertaken.|||units on a scale||Standard Deviation|Mean
2737119|NCT00970944|Secondary|JFK Coma Recovery Scale-Revised: Neurobehavioral Status|"Measure of neurobehavioral function and clinical change for individuals with severe alterations of consciousness.~Minimum score= 0; Maximum score= 23 (Higher scores are indicative of a higher-level of neurobehavioral function)."|Week 4 (primary endpoint); Week 6 (post-washout)|Analyses were conducted according to the ITT principle so that all 184 patients randomized were included for analysis. Imputation techniques were not undertaken since missing data were infrequent and unrelated to study outcome.|||units on a scale||Standard Deviation|Mean
2737120|NCT00970853|Secondary|Teacher Rating Form (TRF), Total Problems|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737121|NCT00970853|Secondary|Teacher Rating Form (TRF), Externalizing|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737122|NCT00970853|Secondary|Teacher Rating Form (TRF), Internalizing|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with scores from age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. value is 80; best value is 30."|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737123|NCT00970853|Secondary|Child Behavior Checklist (CBCL),Total Problems|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30."|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737124|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Externalizing|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. The worst possible score is 80 and the best possible score is 30."|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737125|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Internalizing|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30."|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737126|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math|The WJR-III, Ach, Broad Math measures math academic achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Math was selected because its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families. The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737127|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading|The WJR-III, Ach, Broad Reading measures reading achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Broad Reading was selected because it includes indices of reading and a recent standardization sample that includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry||||units on a scale||Standard Deviation|Mean
2737128|NCT00970853|Primary|Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)|The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years post original enrollment in study|All were included.|||units on a scale||Standard Deviation|Mean
2737129|NCT00970814|Primary|The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Study Weeks 5-14||||percentage of heavy drinking days||Standard Error|Least Squares Mean
2737130|NCT00970814|Secondary|The Number of Drinks Per Drinking Day Study Weeks 5-14.|based on self report|Study Weeks 5-14||||drinks per day||Standard Error|Least Squares Mean
2737131|NCT00970814|Primary|The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Weeks 5-14||||percentage of subjects|||Number
2737132|NCT00970736|Secondary|Area of Submental Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.|2 weeks|This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses.||||||
2737133|NCT00970736|Secondary|Motor Map Center of Gravity|Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).|2 weeks|This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses.||||||
2737134|NCT00970736|Primary|Mean Motor Evoked Potential Amplitude for Submental Cortical Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.|2 weeks|This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses.||||||
2737135|NCT00970684|Secondary|Best Response|The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)|1 year|One patient was unevaluable for response due to missing baseline tumor measurement.|||participants|||Number
2737136|NCT00970684|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.|1 year|Intent to treat|||months||95% Confidence Interval|Median
2737137|NCT00970684|Primary|Progression Free Survival(PFS)|PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.|1 year|Intent to treat|||months||95% Confidence Interval|Median
2737138|NCT00970632|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|PVR was the amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliter (mL)||Standard Deviation|Median
2737139|NCT00970632|Secondary|Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks|V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliter (mL)||Standard Deviation|Median
2737140|NCT00970632|Secondary|Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks|Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliters per second (mL/sec)||Standard Deviation|Median
2737284|NCT00969332|Secondary|Number of Participants With Essential Fatty Acid Deficiency|triene:tetraene ratio less than 0.2|24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)||||Participants|||Count of Participants
2737141|NCT00970632|Secondary|Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks|Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliters per second (mL/sec)||Standard Deviation|Median
2737142|NCT00970632|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks|IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all randomized sexually active participants with erectile dysfunction who started study medication, and had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737143|NCT00970632|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline measurement.|||units on a scale||Standard Deviation|Median
2737144|NCT00970632|Secondary|Clinician Global Impression of Improvement (CGI-I) at 12 Weeks|"The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant's symptoms based on a 7-point scale. A score of 1=participant felt symptoms were very much better; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt no change in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were very much worse."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.|||participants|||Number
2737145|NCT00970632|Secondary|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|"The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant's symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were very much better; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt no change in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were very much worse."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.|||participants|||Number
2737146|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737147|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737148|NCT00970632|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week|The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 1 week|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737149|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks|IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2744163|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||pg/ml||Standard Deviation|Mean
2737150|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks|The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737151|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.|IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737152|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks|IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737153|NCT00970632|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737154|NCT00970632|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2737155|NCT00970606|Primary|Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).|No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of >2000 participants planned/anticipated actually enrolled.|28 days|Only 7 participants were enrolled in this study designed for >2000. No formal anlaysis of outcomes was performed as tne n was too small to show any differences||||||
2737156|NCT00970502|Secondary|Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity|At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.|1 year||||percentage of participants|||Number
2737157|NCT00970502|Secondary|Locoregional Progression|Patients with locoregional and/or distant progression|20 months||||participants|||Number
2737158|NCT00970502|Secondary|Clinical Response|Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|20 months||||Participants|||Count of Participants
2737159|NCT00970502|Primary|Toxicity|Number of participants with acute and late toxicity|30 DAYS|Erlotinib and celecoxib were administered orally|||participants|||Number
2737160|NCT00970489|Secondary|Other Endpoints|"Number of days in the ICU, of telemetry monitoring, and of total hospital stay.~Non-AF arrhythmias of at least 30 sec duration, including non-AF-SVT, ventricular tachycardia (VT), and ventricular flutter (VF), assessed and adjudicated by the Events Committee.~MACE: Combined total mortality, myocardial infarction, and stroke.~Bleeding, assessed by (a) chest tube output in the 24 hour period following surgery and (b) total number of packed red blood cell (RBC) transfusions from enrollment to end of treatment (hospital discharge or post-op day 10).~Significant adverse events: Discontinuation of study treatment, at the discretion of the treating physicians, for suspected significant allergic reaction, severe gastrointestinal intolerance, significant bleeding, or other side effects requiring discontinuation.~Thirty-day mortality assessed~One-year mortality assessed"|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
2737161|NCT00970489|Secondary|Other Arrhythmias|"The first 3 suspected episodes of atrial fibrillation or flutter of at least 30 sec duration following randomization were documented, including the following information:~Printed or digital rhythm strip and/or 12-lead ECG.~Recording of time of onset and time of cessation.~Additional documentation of temporally associated signs of symptoms, such as new or worsening chest pain, shortness of breath, or lightheadedness; drop in blood pressure requiring escalation of fluid or pressor treatment; or need for electrical or pharmacologic cardioversion.~The first suspected episode of each of other supraventricular or unknown narrow-complex tachycardia of at least 30 sec duration following randomization was also documented."|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
2737162|NCT00970489|Secondary|Post-op Af|Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality.|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
2737163|NCT00970489|Primary|Any First Post-op Atrial Fibrillation or Flutter (AF)|Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
2737164|NCT00970359|Secondary|Change From Baseline in Serum Thyroglobulin Levels After Treatment With 131I|Will perform a Wilcoxon signed rank test for paired samples to compare the serum thyroglobulin level before and after 131I treatment in the subset of patients treated with 131I following AZD6244.|At 2 months and 6 months after Radioiodine administration|Only patients treated with Radioiodine.|||percentage of reduction of levels||Full Range|Mean
2737165|NCT00970359|Primary|Tumor Response Defined as Either a Complete Response or Partial Response|as defined by the RECIST v1.1 criteria Descriptive statistics will be used to summarize the data.|6 months|Only patients treated with radioiodine.|||participants|||Number
2737166|NCT00970359|Primary|Number of Patients Whose Tumor(s) Acquire an Increased Propensity for Iodine Uptake as Detected on Iodine-124 Positron Emission Tomography Scan||2 years||||participants|||Number
2737167|NCT00970320|Secondary|Change in Manometry Measurements|manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction|12 to 24 months postpartum|||||||
2737168|NCT00970320|Secondary|Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale|Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).|12 to 24 months postpartum|||||||
2737169|NCT00970320|Secondary|Fecal Incontinence of Life (FIQL) Scale|Change in health-related quality of Life as measured on the fecal incontinence quality of life scale (FIQL). There is no total scale, only four sub scales ranging from 4 (complete continence, no impact on QoL) to 1 (complete incontinence, severe impact on QoL) Data from the postpartum period has not and will not be analysed due to low numbers.|0 to 24 months postpartum|||||||
2737170|NCT00970320|Secondary|Change in Urinary Incontinence as Measured on ICI-Q UI SF|"International Consultation of Incontinence Questionnaire, short form (ICI-Q SF) ranges from 0 (Complete continence) to 21 (Complete incontinence) and measures the frequency of UI, amount of leakage and impact on quality of life.~Data have not been analysed."|0 to 24 months postpartum|||||||
2737171|NCT00970320|Primary|Change in Anal Incontinence as Measured on the St. Mark's Score|Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI). The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum. Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.|0 to 24 months postpartum||||units on a scale||Standard Deviation|Mean
2737172|NCT00970307|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (from Month 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2737173|NCT00970307|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2737174|NCT00970307|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.|||Participants|||Count of Participants
2737175|NCT00970307|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.|||Participants|||Count of Participants
2737176|NCT00970307|Secondary|Anti-PD Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2737177|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-protein D (Anti-PD)|A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737178|NCT00970307|Secondary|Anti-pneumo Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||µg/mL||95% Confidence Interval|Geometric Mean
2737179|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes|A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737180|NCT00970307|Secondary|Anti-polio Types 1, 2 and 3 Antibody Titers|Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Titers||95% Confidence Interval|Geometric Mean
2737181|NCT00970307|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737182|NCT00970307|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2737183|NCT00970307|Secondary|Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737184|NCT00970307|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN|A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737185|NCT00970307|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2737186|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737187|NCT00970307|Secondary|Anti-D and Anti-T Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2737188|NCT00970307|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)|A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737189|NCT00970307|Secondary|Anti-PSC Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||µg/mL||95% Confidence Interval|Geometric Mean
2737190|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)|A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737191|NCT00970307|Secondary|Antibody Titers Against rSBA-MenC|The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Titers||95% Confidence Interval|Geometric Mean
2737192|NCT00970307|Secondary|Anti-PRP Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||µg/mL||95% Confidence Interval|Geometric Mean
2737193|NCT00970307|Primary|Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)|A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737194|NCT00970307|Primary|Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
2737195|NCT00970294|Secondary|Glycemic Control|HbA1c measure|Baseline and at 10 weeks (change score)||||percentage of glycosolated hemoglobin||Standard Deviation|Mean
2737196|NCT00970294|Secondary|Aerobic Fitness|peak VO2 as measured with a graded maximal exercise test on a cycle ergometer|Baseline and at 10 weeks (change score)||||mL/kg/m||Standard Deviation|Mean
2737197|NCT00970294|Primary|Recruitment, Retention, Adherence|% of enrolled subjects who completed the trial|10 weeks||||percentage of participants|||Number
2737198|NCT00970281|Secondary|Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection|Assesses extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms; 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). Total points of 8 items are defined as DIEPSS total (0 to 32 points). Items for assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by points given to corresponding items (item 6, item 7, and item 8, respectively).|Up to 24 hours after the first IM injection|Participants with an abnormal value at post-baseline, last observation carried forward (LOCF).|||percentage of participants|||Number
2737199|NCT00970281|Secondary|Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|up to 24 hours after the first IM injection|Participants having a post-baseline measure, last observation carried forward (LOCF).|||percentage of participants|||Number
2737216|NCT00969761|Secondary|Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment|"Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.~Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)."|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737200|NCT00970281|Secondary|Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Up to 2 hours after the first (IM) injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).|||percentage of participants|||Number
2737201|NCT00970281|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 24 hours after first IM injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2737202|NCT00970281|Secondary|Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2737203|NCT00970281|Primary|Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 2 hours after first IM injection|Participants with a baseline and a value at the time, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2737204|NCT00970268|Secondary|Change From Baseline in Peak FEV1|Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).|52 weeks||||L||Standard Error|Least Squares Mean
2737205|NCT00970268|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1|Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks|From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population|||L||Standard Error|Least Squares Mean
2737206|NCT00970216|Primary|HBV-DNA < 300 Copies/mL in 48 Weeks||48 weeks||||participants|||Number
2737207|NCT00970073|Secondary|Allograft Rejection Rates at 30 Days|Acute Allograft Rejection|30 days||||Participants|||Count of Participants
2737208|NCT00970073|Secondary|Graft Survival|90% graft survival, related to the deaths of 3 patients during the study period.|12 months post transplant|Kaplan Meier for patient survival|||Participants|||Count of Participants
2737209|NCT00970073|Secondary|Patient Survival||12 months post-transplant|Kaplan- Meier|||Participants|||Count of Participants
2737210|NCT00970073|Primary|Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery|Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.|12 Months||||mL/min||90% Confidence Interval|Median
2737211|NCT00969878|Secondary|•The Immunogenicity of TA-CD;|Peak antibody levels after five vaccinations with TA-CD, which occurred at week 16.|During the 18 weeks study period.||||micrograms/ml||95% Confidence Interval|Mean
2737212|NCT00969878|Primary|Cocaine Abstinence During Weeks 9 to 16 Inclusive|Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo|Over 8 weeks ( Study Weeks 9 to 16 inclusive)||||participants|||Number
2737213|NCT00969761|Secondary|Worst CTCAE Grade on Treatment for Neutrophils|Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Units on a scale|||Number
2737214|NCT00969761|Secondary|Worst CTCAE Grade on Treatment for Platelets|Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Units on a scale|||Number
2737215|NCT00969761|Secondary|Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment|"Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.~Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)"|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737251|NCT00969553|Secondary|Disease Control|The disease control (DC) presented are the percentage of patients with CR, PR or stable disease as best response throughout the study assessed by tumour measurement and evaluated according to RECIST, version 1.0.|At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)|The treated set|||percentage of patients|||Number
2737217|NCT00969761|Secondary|Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment|"Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.~Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)"|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737218|NCT00969761|Secondary|Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment|"Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.~Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)."|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737219|NCT00969761|Secondary|Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets|"Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets >=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.~The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)."|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737220|NCT00969761|Secondary|Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils|Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils >=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737221|NCT00969761|Secondary|Change From Baseline in Platelets|Change from baseline in platelets with the maximum value on treatment|Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||10^9 cells /L||Standard Deviation|Mean
2737222|NCT00969761|Secondary|Change From Baseline in Neutrophils|Change from baseline in neutrophils with the maximum value on treatment|Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||10^9 cells /L||Standard Deviation|Mean
2737223|NCT00969761|Secondary|Change From Baseline in Pulse Rate|Change from baseline in pulse rate at last value on treatment|Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||bpm||Standard Deviation|Mean
2737224|NCT00969761|Secondary|Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)|Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.|1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion|PK set|||Litres||Geometric Coefficient of Variation|Geometric Mean
2737225|NCT00969761|Secondary|Total Plasma Clearance After Intravascular Administration (CL)|Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.|1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion|Pharmacokinetic (PK) set which included all participants in the treated set with evaluable PK data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2737226|NCT00969761|Secondary|Percentage of Participants With Significant Adverse Events|"Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.~DLTs (i.e. significant AEs) per protocol were:~drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)~drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection~drug related CTCAE Grade 4 thrombocytopenia~drug related febrile neutropenia grade 3 (ANC<1000/mm³ and fever≥ 38.5°C)"|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737227|NCT00969761|Secondary|Percentage of Participants With Serious Adverse Events|Percentage of participants with serious adverse events (AEs)|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737228|NCT00969761|Secondary|Incidence and Intensity of Adverse Events According to CTCAE Version 3.0|Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737229|NCT00969761|Secondary|Progression-free Survival|Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Days||Full Range|Median
2737230|NCT00969761|Secondary|Duration of Disease Control|Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set restricted to participants with confirmed disease control.|||Days||Standard Deviation|Median
2737231|NCT00969761|Secondary|Disease Control Rate|Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737232|NCT00969761|Secondary|Best Overall Response|Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2752996|NCT00855738|Secondary|Time to First Seizure|Number of days to first seizure after baseline.|Baseline to Month 6 (or end of treatment)|FAS LOCF. N=number of subjects with evaluable data.|||days||Standard Deviation|Mean
2737233|NCT00969761|Secondary|Duration of Objective Response|"Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.~Tumour response was documented using appropriate techniques"|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set restricted to participants with confirmed objective response.|||Days||Full Range|Median
2737234|NCT00969761|Secondary|Objective Response Rate|"Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).~Tumour response was documented using appropriate techniques"|From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days|Treated set|||Percentage of participants|||Number
2737235|NCT00969761|Secondary|Percentage of Participants With Dose Limiting Toxicities|Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.|3 weeks|"Treated set.~There was one patient in the V300+Car6 group whose DLT data was not evaluable, so only 12 patients had evaluable data."|||Percentage of participants|||Number
2737236|NCT00969761|Primary|Maximum Tolerated Dose|"The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.~0=not maximum tolerated dose, 1=was maximum tolerated dose."|3 weeks|Treated set|||Units on a scale|||Number
2737237|NCT00969709|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe for all measured symptoms)|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment(Intent to Treat [ITT] Population).|||units on a scale||Standard Error|Mean
2737238|NCT00969709|Primary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|"The MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity for all measured symptoms)."|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment (Intent to Treat [ITT] Population).|||Units on a scale||Standard Error|Least Squares Mean
2737239|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items|The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMD-17 measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2737240|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A Informant scores measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2737241|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CGI-ADHD-S measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2737242|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items|The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMA-14 measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2754583|NCT00844831|Primary|Presence of Small Intestinal Bacterial Overgrowth|Percent of patients with bacterial overgrowth before and after treatment.|28 days|ITT|||Participants|||Count of Participants
2737243|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A self report measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2737244|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores|AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline AAQoL measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2737245|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)|CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CAARS measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
2737246|NCT00969618|Primary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through 48 weeks|All participants who received at least one dose of study drug.|||participant|||Number
2737247|NCT00969553|Secondary|Pharmacokinetics (PK) Cmax of Volasertib|The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure Cmax is presented.|Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h|Treated Set. All evaluable patients were included in the PK analyses. Patients who were considered not evaluable were not included. A patient was considered to be not evaluable if they had an important protocol violation relevant to the evaluation of PK, or they had insufficient data. D1 Schedule, no administration of trial drug on Day 8.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2737248|NCT00969553|Secondary|Pharmacokinetics (PK) AUC0-168 of Volasertib|The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-168 is presented.|Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h|Treated Set. All evaluable patients were included in the PK analyses.|||in nanogram*hours/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2737249|NCT00969553|Secondary|Pharmacokinetics (PK) AUC0-∞ of Volasertib|The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-∞ is presented.|Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h|Treated Set. All evaluable patients were included in the PK analyses. Patients who were considered not evaluable were not included. A patient was considered to be not evaluable if they had an important protocol violation relevant to the evaluation of PK, or they had insufficient data.|||in nanogram*hours/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2737250|NCT00969553|Secondary|Sum of the Largest Diameters of Target Lesions|The individual time profile of the sum of the largest diameters of target lesions (LD) is presented graphically for each patient in the Clinical Trial Report (CTR) only. No descriptive statistics were planned.|At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)|No descriptive statistics were calculated, but the time profile of sum of largest diameter was plotted for each patient.||||||
2737267|NCT00969540|Secondary|Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Minutes||Standard Deviation|Mean
2737252|NCT00969553|Secondary|Response Duration|The duration of overall response was measured from the time measurement criteria were met for complete response (CR) or partial response (PR), whichever was recorded first, until the first date that recurrent or progressive disease was objectively documented. The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented.|From first drug administration up to at 3 month interval after final End of treatment visit until disease progression, death, or lost to follow-up, up to 548 days|The reason not to analyze the duration of objective response is that only 2 patients in different arms achieved an objective response and the analysis would reduce to a single patient case report.||||||
2737253|NCT00969553|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. PFS was assessed by tumour measurement and evaluated according to RECIST, version 1.0.|At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)|The treated set|||days||Full Range|Median
2737254|NCT00969553|Secondary|Objective Response|"The objective response (OR) was defined as complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest) assessed by tumour measurement and evaluated according to the Response Evaluation Criteria in solid tumours (RECIST), version 1.0.~The data represents the percentage of patients."|At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)|The treated set|||percentage of patients|||Number
2737255|NCT00969553|Secondary|ECG|This endpoint will be presented as a change from individual baseline in QT interval, corrected according to Fridericias formula (QTcF) to end of infusion (2 hours) and 24 hours after first infusion in Cycle 1.|Baseline, 2 hours (before the end of infusion of volasertib) and 24 hours after first infusion in Cycle 1|Treated Set, only the patients in the Maximum Tolerated Dose (MTD) groups are evaluated for this endpoint.|||milliseconds (ms)||Standard Deviation|Mean
2737256|NCT00969553|Secondary|Vital Signs (Pulse Rate)|This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure the pulse rate is presented.|Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)|Treated Set|||bpm||Standard Deviation|Mean
2737257|NCT00969553|Secondary|Vital Signs (Blood Pressure)|This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure SBP and DBP are presented.|Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)|Treated Set|||mmHg||Standard Deviation|Mean
2737258|NCT00969553|Secondary|Patient Performance|This endpoint will present the best clinical assessment. The investigator will perform a clinical assessment. An evaluation will be done whether the patient appears to be clinically improved, unchanged, or deteriorated. The presented numbers show the percentage of patients.|From first administration of volasertib to the last dose, up to 527 days|Treated Set|||percentage of participants|||Number
2737259|NCT00969553|Secondary|Change From Baseline to Last Value on Treatment in Neutrophils|This endpoint will be presented as a change from baseline to last value on treatment in neutrophils.|Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)|Treated Set|||10^9 neutrophils / Litre (L)||Standard Deviation|Mean
2737260|NCT00969553|Secondary|Change From Baseline to Last Value on Treatment in Platelets|This endpoint will be presented as a change from baseline to last value on treatment in platelets.|Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)|Treated Set|||10^9 platelets/ Litre (L)||Standard Deviation|Mean
2737261|NCT00969553|Secondary|Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0|Percentage of participants with incidence and intensity of drug-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. This endpoint will be presented as a percentage of patients with adverse event by treatment and the highest CTCAE grade of the related AE.|From first administration of volasertib to 21 days after the last dose, up to 548 days|Treated Set|||Percentage of participants|||Number
2737262|NCT00969553|Primary|MTD of Volasertib|Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. This outcome measure shows the MTD.|From the first administration of study drug up to 3 weeks|The treated set.|||milligram (mg)|||Number
2737263|NCT00969553|Primary|Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib|Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. The MTD was defined on the basis of DLTs observed during the first treatment course only. In this outcome measure the percentage of participants with DLTs in cycle 1 is presented.|From first administration of study drug up to 3 weeks|The treated set consisted of all patients whe received at least one dose of volasertib.|||percentage of participants|||Number
2737264|NCT00969540|Secondary|Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Minutes||Standard Deviation|Mean
2737265|NCT00969540|Secondary|Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Percentage of time asleep||Standard Deviation|Mean
2737266|NCT00969540|Secondary|Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Awakenings||Standard Deviation|Mean
2737269|NCT00969540|Primary|Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).|"The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention).~The daily scores range from 1 (very much improved) to 7 (very much worse)."|14 days|The sponsor determined the size of the study.|||units on a scale||Standard Deviation|Mean
2737270|NCT00969501|Primary|Number of Participants With a Reduction in Pain by the Scores.|Greater than 50 percent reduction in pain scores from baseline.|6 months|￼|||participants|||Number
2737271|NCT00969436|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.|From the first study dose up to study end (Month 0 to Month 7.5 approximately)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737272|NCT00969436|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event|An unsolicited Adverse Event (AE) covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 43-day (Days 0-42) after the first and second vaccination dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737273|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Rash|Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination|During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2737274|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2737275|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2737276|NCT00969436|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2737277|NCT00969436|Secondary|Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses|Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).|At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
2737278|NCT00969436|Secondary|Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.|Approximately 42 to 56 days after the first vaccine dose at week 6|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.|||Participants|||Count of Participants
2737279|NCT00969436|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies|Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42 - 56 days after the second vaccination dose at week 30|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.|||Participants|||Count of Participants
2737280|NCT00969332|Secondary|Markers of Fatty Acid Metabolism|Erythrocyte fatty acid - Docosahexaenoic Acid|24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)||||Percent of Sum of Fatty Acids||Standard Deviation|Mean
2737281|NCT00969332|Secondary|Markers of Bile Acid Metabolism|Serum Bile acids - total chenodeoxycholic acid|24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)||||umol/L||Standard Deviation|Mean
2737286|NCT00969332|Secondary|Growth Z-scores|"Weight Z-scores at the end of the study. Formula used: (weight at end of study-average weight of reference population)/standard deviation of weight of reference population.~The Z-score indicates the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A weight Z-score </= -2 indicates an underweight or malnourished status, while a weight Z-score >/= 2 indicates an overweight or obese status."|24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)||||Z-score||Standard Deviation|Mean
2737287|NCT00969332|Secondary|Time to Full Enteral Feeds|discontinuation of parenteral nutrition|24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)||||weeks||Standard Deviation|Mean
2737288|NCT00969332|Secondary|Number of Participants Who Underwent a Transplant|includes isolated liver or multi-visceral transplant including liver graft|24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)||||Participants|||Count of Participants
2737289|NCT00969332|Secondary|Death|expiration|24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)||||Participants|||Count of Participants
2737290|NCT00969332|Primary|Time to Reversal of Parenteral Nutrition Associated Cholestasis|weeks|24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)||||weeks||Standard Deviation|Mean
2737291|NCT00969280|Secondary|General Assessment||visit 11|||||||
2737292|NCT00969280|Secondary|Medication Quantification Scale (MQS)||every visit|||||||
2737293|NCT00969280|Secondary|Tear Film Break-up Time : BUT||Visit 1, 10|||||||
2737294|NCT00969280|Secondary|Schirmer 1 Test||visit 1,10|||||||
2737295|NCT00969280|Secondary|Visual Analogue Scale of Self Symptoms||every visit|||||||
2737296|NCT00969280|Primary|Ocular Surface Disease Index : OSDI|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline."|Visit 11 (after 3 weeks from baseline)|Statistical analyses were conducted on an intention-to-treat basis (ITT analysis, significance p<0.05). According to the last observation carried forward method (LOCF method), the last observed missing values were used to complete missing values from drop-out participants.|||Scores on the OSDI score|Participants|Standard Deviation|Mean
2737297|NCT00969228|Secondary|Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)||From Dose 1 up to 1 month after Dose 2.|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2737298|NCT00969228|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (2-3 months).|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2737299|NCT00969228|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2737300|NCT00969228|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.|During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2737301|NCT00969228|Secondary|Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
2737302|NCT00969228|Primary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A|Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2737303|NCT00969150|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8||||units on a scale||Standard Error|Least Squares Mean
2737304|NCT00969150|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat [ITT] Population).|||units on a scale||Standard Error|Least Squares Mean
2737305|NCT00969124|Secondary|Time Spent During Withdrawal Phase and Total Procedure|Time in minutes for withdrawal phase of procedure and for total procedure|During the colonoscopy procedure (up to 1 hour, average 25 minutes)||||minutes||Standard Deviation|Mean
2737306|NCT00969124|Primary|Detection Rates for All Polyps|All polyps detected with the colonoscope alone vs. with the Retroscope|During the colonoscopy procedure (up to 1 hour, average 25 minutes)||||All polyps|||Number
2737309|NCT00968981|Secondary|Duration of Response (DR)|DR during first line therapy is defined as the time from when response (complete response [CR] or partial response [PR]) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. CR: disappearance of all target lesions (TLs) with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters. PR: at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum diameters. DR was not calculated as only 1 responding participant reached their response at the last scheduled response assessment, hence follow-up data are not available.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|||||||
2737310|NCT00968981|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449|AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified time point in each group.|||mcM*hour||Standard Deviation|Mean
2737311|NCT00968981|Primary|Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified timepoint in each group.|||mcM*hour||Standard Deviation|Mean
2737312|NCT00968981|Primary|Maximum Plasma Concentration (Cmax) of Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.|0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose|PK Evaluable Population. 'n' signifies number of participants with data available at specified timepoint in each group.|||mcM||Standard Deviation|Mean
2737313|NCT00968981|Primary|Plasma Concentration at Steady State (Css) for Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. N = participants with baseline and post baseline data available for measurement of Css at steady state.|||mcM||Standard Deviation|Mean
2737314|NCT00968981|Primary|Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15|Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. N = participants who completed Day 57 of the study were included in this analysis.|||ratio||Full Range|Mean
2737315|NCT00968981|Primary|Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)|Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. Here number of participants analyzed (N) = participants with baseline and at least 1 post baseline assessment for this outcome.|||participants|||Number
2737316|NCT00968981|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449||Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. Number of participants analyzed (N) is equal to (=) participants with baseline and at least one post-baseline assessment for this outcome; n = participants evaluable at specified time-points.|||hours||Full Range|Median
2737317|NCT00968981|Secondary|Progression-Free Survival (PFS) Time|PFS defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by the investigator review of tumor assessments using RECIST, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population.|||months||95% Confidence Interval|Median
2737318|NCT00968981|Secondary|Percentage of Participants With a Response by Best Overall Response (BOR)|BOR was defined as the best overall response observed during the treatment period according to RECIST. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population; only participants with measurable disease at baseline were included in the analysis.|||percentage of participants|||Number
2737331|NCT00968890|Secondary|Number of Seroprotected Subjects|A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
2737319|NCT00968981|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression (assessed by Response Evaluation Criteria in Solid Tumors [RECIST]) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing non target lesions.|Screening, Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population: all participants who had measurable disease at baseline and either had at least one follow-up tumor assessment or discontinued the study due to disease progression.|||percentage of participants|||Number
2737320|NCT00968968|Secondary|Adverse Event Profile of the Two Treatment Arms||From first dose of study treatment until 30 days after the last dose of study treatment, approximately 8 years.|Safety population: All subjects who received any dose of lapatinib + trastuzumab or trastuzumab.|||Participants|||Count of Participants
2737321|NCT00968968|Secondary|Clinical Benefit Response Rate (CR, PR or SD ≥24 Weeks)|"Clinical Benefit Rate (CBR) was defined as the percentage of patients achieving either a confirmed CR or PR at any time or maintaining SD for at least 24 weeks while on study, according to the investigator assessment of response per RECIST 1.1 criteria.~Confirmed CR - at least two determinations of CR at least 4 weeks apart before PD; Confirmed PR - at least two determinations of PR or better at least 4 weeks apart before PD."|approximately 4 years|Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized|||Percentages of participants||95% Confidence Interval|Number
2737322|NCT00968968|Secondary|Best Overall Response|The best overall response was the best response from the start of the treatment until disease progression/recurrence and was determined programmatically using investigators assessment of responses of target lesion, non-target lesion and new lesions based on RECIST v1.1. Complete Response (CR) = disappearance of all target lesion and non-target lesions if applicable, and no new lesion; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions and non-target lesion was neither complete response nor progressive disease (Non-CR/Non-PD) or not evaluable (NE); SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD = ≥ 20% increase from nadir of the target lesions or appearance of new lesion. CR and PR were confirmed responses. Confirmed CR - at least two determinations of CR at least 4 weeks apart before PD; Confirmed PR - at least two determinations of PR or better at least 4 weeks apart before PD.|approximately 4 years|Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized|||Participants|||Number
2737323|NCT00968968|Secondary|Overall Survival|Overall Survival is defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.|Time from randomization until death, approximately 4 years|Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized.|||Months||95% Confidence Interval|Median
2737324|NCT00968968|Primary|Progression-free Survival|"Progression-free survival (PFS) with lapatinib plus trastuzumab versus trastuzumab alone.~Progression-free survival (PFS) is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to last contact date up to 21Feb2014.~Disease Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1), a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum diameters recorded since the treatment started (the sum must have an absolute increase from nadir of 5mm), or an unequivocal progression of existing non-target lesions, or the appearance of new lesions."|Time from randomization until disease progression or death, approximately 4 years|Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized.|||months||95% Confidence Interval|Median
2737325|NCT00968890|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737326|NCT00968890|Secondary|Number of Subjects With Adverse Events of Specific Interest|Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737327|NCT00968890|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|From Day 0 to Day 83|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737328|NCT00968890|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).|Within 7 days (Day 0-Day 6) after each vaccination|Analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2737329|NCT00968890|Secondary|Number of Subjects With Titers Equal to or Above Titer 1:10|"The cut-off 1:10 was considered as seropositivity.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
2737330|NCT00968890|Secondary|Geometric Mean Fold Rise (GMFR)|The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||ratio||95% Confidence Interval|Geometric Mean
2739132|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|6 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2737332|NCT00968890|Secondary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
2737333|NCT00968890|Secondary|Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains|"Titers are expressed as GMTs.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2737334|NCT00968890|Primary|Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix|"The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||ratio||95% Confidence Interval|Geometric Mean
2737335|NCT00968890|Primary|Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
2737336|NCT00968890|Primary|Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
2737337|NCT00968864|Secondary|Device Performance: Dose of CD34+ Cells and CD3+ Cells Given|"For mismatched related donors, the target cell dose after processing is >/= 20 x 10^6 CD34+ cells/kg patient body weight, but >/= 8 x 10^6 is acceptable.~For unrelated donors the target cell dose after processing is >/= 10 x 10^6 CD34+ cells/kg patient body weight, but >/= 4 x 10^6 is acceptable.~The target T cell dose is </= 3 x 10^4 CD3+ cells/ kg."|Length of the trial (5 years)||||cells/ kg||Full Range|Mean
2737338|NCT00968864|Secondary|Overall Survival||2 years|Subjects at least 2 years after transplant are evaluable for 2 year overall survival.|||Participants|||Count of Participants
2737339|NCT00968864|Secondary|Number of Participants With Transplant-related Toxicities||1 year||||Participants|||Count of Participants
2737340|NCT00968864|Secondary|Number of Participants With Transplant-related Mortality|Transplant-related mortality includes death due to regimen-related toxicity or GVHD (all causes other than disease relapse). Those who died due to disease relapse are not included in the analyzed population for that time point.|2 year|Those who died due to disease relapse are not included in the analyzed population for that time point.|||Participants|||Count of Participants
2737341|NCT00968864|Secondary|Number of Participants With Post-transplant Leukemia Relapse||5 years|Of the 43 recipients in the mismatched related donor cohort, 24 of those had leukemia. No recipients in the matched unrelated donor cohort had leukemia.|||Participants|||Count of Participants
2737342|NCT00968864|Secondary|Number of Participants With EBV-related Post Transplant Lymphoproliferative Disorder (PTLD)||5 years||||Participants|||Count of Participants
2737343|NCT00968864|Secondary|Number of Participants With Post-transplant Infections||1 year||||Participants|||Count of Participants
2737344|NCT00968864|Secondary|Number of Participants With Engraftment and Time to Engraftment|Engraftment was measured as time to absolute neutrophil count >500|Within 28 days after stem cell transplant|There were 2 cases of primary graft failure in the mismatched related donor cohort; both achieved engraftment following a second transplant.|||days||Full Range|Mean
2737345|NCT00968864|Primary|Number of Participants With Severe Graft vs. Host Disease (GVHD).|Severe GVHD defined as grade III/IV GVHD.|Within 30 days after stem cell transplant||||Participants|||Count of Participants
2737346|NCT00968838|Primary|Number of Participants Alive at Day 30|Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).|30 Days||||Participants|||Number
2737347|NCT00968812|Secondary|Change in HbA1c From Baseline to Week 104|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Baseline, Week 104|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug).|||Percent||Standard Error|Least Squares Mean
2737348|NCT00968812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2737349|NCT00968812|Secondary|Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52|The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2737350|NCT00968812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2737351|NCT00968799|Secondary|Pharmacokinetics|data not analysed due to poor accrual|intraoperative and 1 week after surgery|||||||
2737352|NCT00968799|Secondary|Overall Survival||5 years||||months||Full Range|Median
2737353|NCT00968799|Secondary|Surgical Complications|any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)|6 weeks post operation||||participants|||Number
2737354|NCT00968799|Secondary|Nephrotoxicity|glomerular filtration rate (GFR)|6 weeks post operation||||participants|||Number
2737355|NCT00968799|Primary|Fitness for Systemic Chemotherapy|"Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial.~If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit.~If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit."|3 months post operation||||participants|||Number
2737356|NCT00968708|Secondary|Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)|Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.|From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).|Full analysis set|||percentage of participants|||Number
2737357|NCT00968708|Primary|Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)|Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.|From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).|Full analysis set (all randomized participants)|||percentage of participants|||Number
2737358|NCT00968669|Secondary|Accumulation Ratio of Trough Concentrations of MEDI-528|Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product.|||Ratio||Standard Deviation|Mean
2737359|NCT00968669|Secondary|Half Life of MEDI-528|Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).|||Days||Standard Deviation|Mean
2737360|NCT00968669|Secondary|Day 169 Steady State Trough Concentration of MEDI-528|Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169.|Day 169|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).|||Microgram per milliliter||Standard Deviation|Mean
2737361|NCT00968669|Secondary|First Dose Trough Concentration of MEDI-528|First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose.|Day 15|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).|||Microgram per milliliter||Standard Deviation|Mean
2737362|NCT00968669|Secondary|Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528|Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo|Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product.|||Participants|||Number
2737469|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study|Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737363|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively).|||Participants|||Number
2737364|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 85|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively).|||Participants|||Number
2737365|NCT00968669|Secondary|Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176|Day 176|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo).|||Liters||Standard Deviation|Mean
2737366|NCT00968669|Secondary|Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo).|||Liters||Standard Deviation|Mean
2737367|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176.|||Day||95% Confidence Interval|Median
2737368|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92.|||Day||95% Confidence Interval|Median
2737369|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.|||Participants|||Number
2739133|NCT00957359|Primary|HADS Depression|0-21 (higher score more depression)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2737370|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92.|||Participants|||Number
2737371|NCT00968669|Secondary|Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)|Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.|||Scores on a scale||Standard Deviation|Mean
2737372|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Day||95% Confidence Interval|Median
2737373|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Day||95% Confidence Interval|Median
2737374|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Participants|||Number
2737375|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Participants|||Number
2737468|NCT00968201|Secondary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737376|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Exacerbations per participant year||95% Confidence Interval|Number
2737377|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Exacerbations per participant year||95% Confidence Interval|Number
2737378|NCT00968669|Primary|Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)|Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups.|||Scores on a scale||Standard Deviation|Mean
2737379|NCT00968617|Secondary|Number of Participants Who Were Responders|Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.|Each week up to 12 weeks||||Participants|||Number
2737380|NCT00968617|Secondary|Change From Baseline in Hemoglobin Level||Weeks 1-3, 5-10, and Week 12||||g/dL||Standard Deviation|Mean
2737381|NCT00968617|Secondary|Hemoglobin Concentration After Treatment With MK2578||Weeks 1-10 and Week 12||||g/dL||Standard Deviation|Mean
2737382|NCT00968617|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||16 Weeks||||Participants|||Number
2737383|NCT00968617|Primary|Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia||16 Weeks||||Participants|||Number
2737384|NCT00968617|Primary|Number of of Participants With Composite Events of Injection Site Reactions||16 Weeks||||Participants|||Number
2737385|NCT00968617|Primary|Number of Participants With Composite Events of Transfusion-related Adverse Experiences||16 Weeks||||Participants|||Number
2737386|NCT00968617|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events||16 Weeks||||Participants|||Number
2737387|NCT00968617|Primary|Change From Baseline in Hemoglobin Level at Week 4||4 weeks||||g/dL||Standard Deviation|Mean
2737388|NCT00968539|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737389|NCT00968539|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737390|NCT00968539|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 83)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2756609|NCT00831129|Secondary|Change in Glycosylated Haemoglobin|change in glycosylated haemoglobin between baseline and 6 month|Baseline and 6 months||||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2737391|NCT00968539|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Temperature.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2737392|NCT00968539|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2737393|NCT00968539|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Redness or Swelling.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with the symptom sheet filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2737394|NCT00968539|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2737395|NCT00968539|Secondary|Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09|Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737396|NCT00968539|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2737397|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Fold increase||95% Confidence Interval|Geometric Mean
2737398|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Fold increase||95% Confidence Interval|Geometric Mean
2737399|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
2737400|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
2737401|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737402|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
2737403|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737404|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737405|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737406|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
2737407|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737408|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737409|NCT00968539|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
2737410|NCT00968539|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2737411|NCT00968539|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2737412|NCT00968539|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/09.|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737413|NCT00968539|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09.|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
2739134|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day post drug administration 1||||score on a scale||Standard Error|Mean
2737414|NCT00968539|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737415|NCT00968539|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
2737416|NCT00968539|Primary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737417|NCT00968539|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737418|NCT00968526|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The results were tabulated per age stratum.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.|||Participants|||Count of Participants
2737419|NCT00968526|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. The results were tabulated per age stratum.|Within 84 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 83)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.|||Participants|||Count of Participants
2737420|NCT00968526|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.|Within 21 days after the first vaccination (Day 0 - Day 20)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.|||Participants|||Count of Participants
2737421|NCT00968526|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], total bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and > 60 years old.|At Days 0, 21, 42, 182 and 364|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.|||Participants|||Count of Participants
2737422|NCT00968526|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. The results were tabulated per age stratum.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.|||Participants|||Count of Participants
2737423|NCT00968526|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (>60y) Sub-Group reported any temperature.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.|||Days||Inter-Quartile Range|Median
2737424|NCT00968526|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome inlcuded only subjects who received two doses of the study product and the results were tabulated per age stratum.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.|||Participants|||Count of Participants
2737425|NCT00968526|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.|During the 7-day (Days 0-6) post-dose 1 vaccination period|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.|||Days||Inter-Quartile Range|Median
2737426|NCT00968526|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (>) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.|During the 7-day (Days 0-6) post-dose 1 vaccination period|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.|||Participants|||Count of Participants
2737427|NCT00968526|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included only subjects who received 2 doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (18-60y) Sub-Group presented any redness post dose 1.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A and who filled in their symptom sheets.|||Days||Inter-Quartile Range|Median
2737428|NCT00968526|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.|||Participants|||Count of Participants
2737429|NCT00968526|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.|During the 7-day (Days 0-6) post-dose 1 vaccination period|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.|||Days||Inter-Quartile Range|Median
2737430|NCT00968526|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.|During the 7-day (Days 0-6) post-dose 1 vaccination period|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.|||Participants|||Count of Participants
2737431|NCT00968526|Secondary|Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09|Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:8 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09. The results were tabulated per age stratum.|At Days 21, 42 and 182|The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against the study vaccine antigen component at Day 182 were available.|||Participants|||Count of Participants
2737432|NCT00968526|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8. The results for this assay were tabulated per age stratum.|At Days 0, 21, 42 and 182|The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against the study vaccine antigen component at Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
2737433|NCT00968526|Secondary|Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:8, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/Neth/602/09. The results for this assay were tabulated per age stratum.|At Days 0, 21, 42 and 182|The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 were available.|||Participants|||Count of Participants
2737434|NCT00968526|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was > 2.5 in subjects 18 to 60 years old or > 2 for subjects > 60 years of age.|At Day 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.|||Fold change||95% Confidence Interval|Geometric Mean
2737435|NCT00968526|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was > 2.5 in subjects 18 to 60 years old or > 2 for subjects > 60 years of age.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 and 42 days after the first vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2737436|NCT00968526|Secondary|Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.|||Participants|||Count of Participants
2737437|NCT00968526|Secondary|Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 and 42 days after the first vaccine dose.|||Participants|||Count of Participants
2737438|NCT00968526|Secondary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post to vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.|||Participants|||Count of Participants
2737439|NCT00968526|Secondary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post to vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days and 42 days after the first vaccine dose.|||Participants|||Count of Participants
2737440|NCT00968526|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. The results for this assay were tabulated per age stratum.|At Day 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and whom assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.|||Titers||95% Confidence Interval|Geometric Mean
2756610|NCT00831129|Secondary|Change in High-density Lipoprotein|change in high-density lipoprotein between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
2737441|NCT00968526|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.|At Day 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.|||Participants|||Count of Participants
2737442|NCT00968526|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. The results for this assay were tabulated per age stratum.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose and 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2737443|NCT00968526|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose and 2 doses were administered and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737444|NCT00968526|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was > 2.5 in subjects 18 to 60 years old or > 2 for subjects > 60 years of age.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2737445|NCT00968526|Primary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.|||Participants|||Count of Participants
2737446|NCT00968526|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer (below) < 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age .|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second dose.|||Participants|||Count of Participants
2737447|NCT00968344|Primary|Lean Leg Mass|DEXA scan of both legs pre/post bed rest|At baseline prior to beginning bed rest and after 14 days of bed rest|Healthy community-dwelling men and women aged 45–60 y|||g||Standard Error|Mean
2737448|NCT00968253|Secondary|Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)|Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures.|Up to 20 cycles of study drugs (21 day cycles) or till disease progression||||participants|||Number
2737449|NCT00968253|Primary|Overall Response Rate (OR) Where OR = CR + CRp + CRi|Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl.|8 courses of treatment, up to 24 weeks||||percentage of participants|||Number
2737450|NCT00968253|Primary|Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)|"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs."|Following first two dose cycles (21 days/each), up to 42 days|Maximum tolerated dose was an outcome measure for the phase I portion of this study only. MTD was already established, therefore, not analyzed on the participants for the phase II portion of this study.|||Participants|||Count of Participants
2737451|NCT00968227|Secondary|Change in Oxygen Extraction Fraction in Regions With Low Baseline Delivery.|Change in oxygen extraction fraction after transfusion of 1 unit of RBC in regions with low baseline delivery (DO2 < 4.5 ml/100g/min.|1 hour||||fraction||Standard Deviation|Mean
2737452|NCT00968227|Primary|Change in Oxygen Delivery in Vulnerable Brain Regions|Change in oxygen delivery after transfusion in brain regions with low baseline delivery.|1 hour||||ml/100g/min||Standard Deviation|Mean
2737453|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension|Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737454|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious LAEs - Extension|Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737455|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension|Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737456|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Extension|Patients who were discontinued due to LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737457|NCT00968201|Secondary|Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients who reported serious drug-related LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737458|NCT00968201|Secondary|Number of Patients With Serious LAEs - Extension|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2737459|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737460|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737461|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension|Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737462|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Extension|Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737463|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension|Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737464|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Extension|Patients who were discontinued due to CAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737465|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension|"Patients who reported serious drug-related CAEs up to 2.8 years of~treatment"|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737466|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Extension|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737467|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
2737470|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Base Study|Patients who were discontinued due to LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737471|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737472|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737473|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study|Patients who were discontinued due to serious CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2737474|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study|Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2737475|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Base Study|Patients who were discontinued due to CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2737476|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study|Patients who reported serious drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2737477|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Base Study|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks of treatment|"All patients who took study medication were included in the analysis.~A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number"|||Participants|||Number
2737478|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|12 weeks of treatment|"All patients who took study medication were included in the analysis.~Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related."|||Participants|||Number
2737479|NCT00968201|Primary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2737480|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737481|NCT00968149|Secondary|Number of Patients With Drug-related LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737482|NCT00968149|Secondary|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737483|NCT00968149|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
2737484|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to CAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
2737485|NCT00968149|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
2737486|NCT00968149|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
2737487|NCT00968149|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
2737488|NCT00968071|Primary|Number of Participants With Complete Response (CR)|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral anc >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.|Up to 36 weeks||||participants|||Number
2737489|NCT00968032|Primary|Number of Participants With a Successful Implantation.|The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.|6 weeks ± 2 weeks||||participants|||Number
2737490|NCT00968019|Secondary|Stroke||Up to 12 months||||participants|||Number
2737491|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 12 months||||participants|||Number
2737492|NCT00968019|Secondary|Major Bleeding||Up to 12 months||||participants|||Number
2737493|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:~Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:~ischemic symptoms~ECG changes indicative of ischemia (ST segment elevation or depression)~Development of pathological Q waves in the ECG~Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality~Pathological findings of an acute myocardial infarction"|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
2737494|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.~Target vessel failure will be reported when:~MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is performed."|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
2737495|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
2737496|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
2737497|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 30 days||||participants|||Number
2737498|NCT00968019|Secondary|Stroke||Up to 30 days||||participants|||Number
2737499|NCT00968019|Secondary|Major Bleeding||Up to 30 days||||participants|||Number
2737500|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:~Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:~ischemic symptoms~ECG changes indicative of ischemia (ST segment elevation or depression)~Development of pathological Q waves in the ECG~Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality~Pathological findings of an acute myocardial infarction"|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
2737501|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.~Target vessel failure will be reported when:~MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is performed."|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
2737502|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
2737503|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
2737504|NCT00968019|Secondary|Procedural Success|Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)|||percentage of Procedural Success|Participants||Number
2737505|NCT00968019|Secondary|Lesion Success|Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)|||percentage of lesion Success|Participants||Number
2737506|NCT00968019|Secondary|Device Success|Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)|||percentage of device success|Participants||Number
2737874|NCT00964444|Primary|Force Exerted on a Fetus as the Delivery Occurs|The amount of force exerted on the fetus was measured in ounces. It was calculated based on measurements from the force transducers in the platform. The obstetrician stands or sits on the platform as the infant is delivered.|Assessment was done after the delivery||||ounces||Standard Deviation|Mean
2737507|NCT00968019|Primary|Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))|"Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).~The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%)."|at 12 months follow-up|No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.|||participants|||Number
2737508|NCT00967993|Secondary|The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.||6 weeks|||||||
2737509|NCT00967993|Primary|The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.||4 weeks||||mg/dL||Standard Deviation|Mean
2737510|NCT00967941|Secondary|Overall Groin Procedures in Patients With and Without Any Infection.||30 days post-operative|Patients with groin procedures.|||Participants|||Number
2737511|NCT00967941|Primary|Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.||30 days post-operative|Patients with MRSA infections.|||participants|||Number
2737512|NCT00967798|Secondary|Change in Percent Predicted FEV1|The decline of lung function was assessed with forced expiratory volume (FEV1), which measures how much air is exhaled during one second of a forced exhale. Change is described as the difference in FEV1 at baseline subtracted from FEV1 at the end of treatment study visit. A protocol change during the study reduced the treatment time from 24 months to 12 months. The end of treatment study visit for participants in the early part of the study occurred at 24 months, while the end of treatment visit was a 12 months for participants enrolling later. Negative values indicate a decline in lung function over the course of the study.|Baseline, end of treatment (Month 12 or Month 24)|The participants included in this analysis are limited to those who have a FEV value for the baseline and end of treatment visits.|||percent predicted||Standard Deviation|Mean
2737513|NCT00967798|Secondary|Change in Inflammatory Cytokines|Hyperglycemia causes release of pro-inflammatory cytokines which can further compromise beta-cell function by increasing insulin resistance and by inducing beta-cell apoptosis. Inflammatory cytokines that have been shown to contribute to destruction of beta-cells include interleukin 1 beta (IL-1b), tumor necrosis factor alpha (TNFa), and interleukin 6 (IL-6).|Baseline through Month 12|Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.||||||
2737514|NCT00967798|Secondary|Change in Redox Couples Glutathione/Glutathione Disulfide and Cysteine/Cystine|Cysteine (Cys)/cystine (CySS) and glutathione (GSH)/glutathione disulfide (GSSG) redox couples are biomarkers of oxidative stress.|Baseline through Month 12|Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.||||||
2737515|NCT00967798|Secondary|Change in Beta-cell Disposition Index|Preservation of beta-cell function was to be assessed with the disposition index, which is a measurement of beta-cell function adjusted for insensitivity to insulin.|Baseline through Month 15|Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.||||||
2737516|NCT00967798|Primary|Number of Participants With Conversion to Cystic Fibrosis Related Diabetes|The number of participants with conversion to cystic fibrosis related diabetes was determined.|Month 15||||Participants|||Count of Participants
2737517|NCT00967694|Primary|Change in Intraocular Pressure During Nitrous Oxide Sedation||Before, during and after administration of nitrous oxide (45 minutes total)||||mmHg (difference in IOP)||95% Confidence Interval|Mean
2737518|NCT00967668|Secondary|Change in Weight|Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.|24 months after enrollment|Includes only individuals who formally consented to participate in the second 12 months of the study.|||kilograms||95% Confidence Interval|Mean
2737519|NCT00967668|Primary|Change in Weight|Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data|12 months after enrollment||||Kilograms||95% Confidence Interval|Mean
2737520|NCT00967551|Secondary|Proportion of Children With Respiratory Infections|Number of children with respiratory infections divided by the total number of children in the group|6 months|All children enrolled|||percentage of participants|||Number
2737521|NCT00967551|Primary|Proportion of Children of Diarrhea Episodes|Number of children with diarrhea divided by the number of children in the group|6 months|All children enrolled|||percentage of participants|||Number
2737522|NCT00967486|Primary|Overall Perioperative Complications Between Selective vs. Routine Shunting.|perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.|Within 30 days of enrollment||||Participants|||Number
2737523|NCT00967473|Primary|Lens Axis Misalignment|Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.|Time of surgery|All implanted subjects were included in this analysis.|||Degrees||Full Range|Mean
2737524|NCT00967473|Primary|Reduction of Cylinder|Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.|6 months after surgery on second eye|All implanted subjects were included in this analysis.|||Percent reduction of cylinder||95% Confidence Interval|Mean
2737890|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 1, Week 2|ITT|||Participants|||Number
2737525|NCT00967473|Primary|Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment|Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.|Before Surgery and 180 days after second eye implant|Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.|||Participants|||Number
2737526|NCT00967447|Secondary|Volume of Wound Drainage||From 12 To 37 Days|The trial was stopped due poor enrollment||||||
2737527|NCT00967447|Secondary|Major Extra Surgical Site Bleedings||From 12 To 37 Days|The trial was stopped due poor enrollment||||||
2737528|NCT00967447|Secondary|Major Bleeding Events (MBE)||From 12 To 37 Days|The trial was stopped due poor enrollment||||||
2737529|NCT00967447|Primary|Venous Thromboembolic Events||6 Months|The trial was stopped due poor enrollment||||||
2737530|NCT00967369|Secondary|Baseline Cytokine/Chemokine Levels With Response to Therapy.||106 weeks/13 months/426 days|Incomplete report as study was stopped early due to futility. Participant with relapsed/refractory HL prior to autologous transplant||||||
2737531|NCT00967369|Secondary|Serum Levels of Tumor Necrosis Factor (TNF) Proteins (APRIL, BLyS, sCD30, and CD40L) and CC Thymus and Activation-related Cytokine (TARC) at Baseline and After 3 Cycles of BICE Versus ICE Chemotherapy||November 2009 and December 2010|Incomplete report as study was stopped early due to futility||||||
2737532|NCT00967369|Secondary|PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy.|Response rates for BICE and ICE treatment groups will be assessed by 1999 IWG (CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria.|Baseline up to 1 year||||Participants|||Count of Participants
2737533|NCT00967369|Primary|Overall Survival (OS) Rate at 24 Months|Overall Survival is time from date of treatment start until date of death due to any cause or last Follow-up within 24 months.|24 months||||percentage of participants|||Number
2737534|NCT00967369|Primary|Progression Free Survival (PFS) Rate at 12 Months|Progression free survival time is defined as the time interval from treatment start to progression or death due to any cause whichever happens first. Participants will be censored at the last follow-up date, if an event(progression/death) is not observed during the follow-up.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||percentage of participants|||Number
2737535|NCT00967369|Primary|Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma|Response rates for Bortezomib, Ifosfamide, Carboplatin, Etoposide (BICE) and Ifosfamide, Carboplatin, Etoposide (ICE) treatment groups were assessed by the 1999 International Working Group (IWG)(CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From baseline to 3 cycles of treatment||||Participants|||Count of Participants
2737536|NCT00967330|Secondary|Time to Treatment Failure||From baseline until end of study (up to 4.5 years)|Data for this outcome measure were not collected as this outcome was removed as per changes in planned analysis.|||years||Full Range|Median
2737537|NCT00967330|Secondary|Percentage of Participants Who Received Corticosteroid for Glioblastoma|Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone.|From baseline to Month 6|The safety population (SAF) was defined to include all participants who received at least 1 dose of study medication. Data were analyzed according to the treatment actually received (as treated).|||percentage of participants|||Number
2737538|NCT00967330|Secondary|Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)|KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score.|Baseline, Post-Baseline (up to Month 30)|ITT population|||units on a scale||95% Confidence Interval|Least Squares Mean
2737539|NCT00967330|Secondary|Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)|The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function.|Baseline, Post-Baseline (up to Month 30)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2737540|NCT00967330|Secondary|Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)|EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Baseline, Post-Baseline (up to Month 30)|ITT population|||units on a scale||95% Confidence Interval|Least Squares Mean
2737541|NCT00967330|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)|The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase.|Baseline, Post-Baseline (up to Month 30)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2737542|NCT00967330|Secondary|Percentage of Participants With Response on FLAIR Imaging|"FLAIR lesions were determined as stable, progressive or decreased. FLAIR lesions was determined as progressive only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population.~Dis.=Discontinuation."|At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)|ITT population. Here, n = participants with at least 1 assessment during specified time-point.|||percentage of participants|||Number
2737543|NCT00967330|Secondary|Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)|BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved.|4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6|ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point.|||participants|||Number
2737544|NCT00967330|Secondary|Percentage of Participants Who Discontinued|Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones.|From baseline until death (up to 4.5 years)|ITT population|||percentage of participants|||Number
2737545|NCT00967330|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method.|From baseline until death (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).|||Months||95% Confidence Interval|Median
2737546|NCT00967330|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method.|From baseline to the end of the study (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).|||Months||95% Confidence Interval|Median
2737547|NCT00967330|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported.|6 months|Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized).|||percentage of participants||95% Confidence Interval|Number
2737548|NCT00967226|Secondary|Constitutional Adverse Events|Number of constitutional AEs in each study arm.|enrollment to study close out or withdrawal up to 9 months||||Adverse Events|||Number
2737549|NCT00967226|Secondary|Vascular Adverse Events|Number of Vascular AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
2737550|NCT00967226|Secondary|Metabolic or Laboratory AEs|Number of Metabolic or Laboratory AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
2737551|NCT00967226|Secondary|Infectious Adverse Events|Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
2737552|NCT00967226|Secondary|Gastrointestinal Adverse Events|Number of Gastrointestinal AEs in each arm|enrollment to study withdrawal or study close out up to 9 months||||Adverse Events|||Number
2737553|NCT00967226|Secondary|Endocrinologic Adverse Events|Number of Endocrinologic AEs (of which adrenal crisis does not overlap).|enrollment to close out or study withdrawal up to 9 months||||Adverse Events|||Number
2737554|NCT00967226|Secondary|Dermatologic Adverse Events|Number of Dermatologic Adverse Events in each study arm.|enrollment to study close out or withdrawal up to 9 months||||Adverse Events|||Number
2737555|NCT00967226|Secondary|Allergy/Immunology Adverse Events|Number of allergy/immunology AE per study arm|enrollment through study closeout or study withdrawal up to 9 months||||Adverse Events|||Number
2737556|NCT00967226|Secondary|Pulmonary/Respiratory Adverse Events|Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm|enrollment through study close out or withdrawal, up to 9 months||||Adverse Events|||Number
2737557|NCT00967226|Secondary|Growth and Development Adverse Events|Number of Growth and Development AEs in each study arm|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
2737558|NCT00967226|Secondary|Number of Serious Adverse Events (SAEs)|Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|enrollment until study close out or withdrawal up to 9 months||||Serious Adverse Events|||Number
2737891|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 8|ITT|||Participants|||Number
2737559|NCT00967226|Secondary|Tolerability of Medication|All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.|enrollment until study close out or withdrawal up to 9 months|"All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. In this table Adverse Events are those exclusive of the Serious Adverse Events which are noted separately."|||Events|||Number
2737560|NCT00967226|Primary|Decrease in Size of Hemangioma (Length x Width) in Square mm|A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.|4-5 months after initiating therapy|Data available at 4 or 5 months for only 9/11 propranolol participants and for 6/8 prednisolone participants due to missed appointments. Overall, 90% (138/154) study appointments were completed.|||mm squared||95% Confidence Interval|Mean
2737561|NCT00967044|Primary|Maximum Tolerated Dose (MTD) of Everolimus With Panobinostat|MTD of the novel combination of Everolimus + Panobinostat (LBH589) in a phase-I study in participants with relapsed lymphoma (Hodgkin and non-Hodgkin) where MTD is defined as the highest dose at which no more than 1 in 6 of the participants in the cohort experiences one or more dose limiting toxicities (DLTs) in the first 28 day treatment cycle. Thirty patients were enrolled onto four dose levels: Everolimus (mg, orally) 5, 5, 10, 10 daily or Panobinostat (mg, orally) 10, 20, 20, 30 three times per week. The MTD was established without the use of colony stimulating factor in cycle 1.|28 day treatment cycle||||mg, orally|||Number
2737562|NCT00967018|Other Pre-specified|Serum Levels of Testosterone Over Time|Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)|from baseline to week 72|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)|||ng/mL||Full Range|Median
2737563|NCT00967018|Other Pre-specified|Serum Levels of Prostate Specific Antigen (PSA)Over Time|PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)|from baseline to 72 weeks|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)|||ng/mL||Full Range|Median
2737564|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Up to 22.5 months||||Participants|||Number
2737565|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Up to 22.5 months||||Participants|||Number
2737566|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 24||||units on a scale||Standard Deviation|Mean
2737567|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
2737568|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 6||||units on a scale||Standard Deviation|Mean
2737569|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 0 corresponds to baseline. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 0||||units on a scale||Standard Deviation|Mean
2737570|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 24||||units on a scale||Standard Deviation|Mean
2737571|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
2737892|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 1, Week 2|ITT|||Participants|||Number
2737572|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 6||||units on a scale||Standard Deviation|Mean
2737573|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 0 corresponds to baseline. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 0||||units on a scale||Standard Deviation|Mean
2737574|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 24||||units on a scale||Standard Deviation|Mean
2737575|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 12||||units on a scale||Standard Deviation|Mean
2737576|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 6||||units on a scale||Standard Deviation|Mean
2737577|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 0 corresponds to baseline. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 0||||units on a scale||Standard Deviation|Mean
2737578|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 24||||units on a scale||Standard Deviation|Mean
2737579|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 12||||units on a scale||Standard Deviation|Mean
2737580|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. . Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 6||||units on a scale||Standard Deviation|Mean
2737581|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 0 corresponds to baseline. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 0||||units on a scale||Standard Deviation|Mean
2737582|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 24||||units on a scale||Standard Deviation|Mean
2737583|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 12||||units on a scale||Standard Deviation|Mean
2737584|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 6||||units on a scale||Standard Deviation|Mean
2737585|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 0 corresponds to baseline. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 0||||units on a scale||Standard Deviation|Mean
2737893|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No|Week 8|ITT|||Participants|||Number
2737586|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 24||||units on a scale||Standard Deviation|Mean
2737587|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 12||||units on a scale||Standard Deviation|Mean
2737588|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 6||||units on a scale||Standard Deviation|Mean
2737589|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 0||||units on a scale||Standard Deviation|Mean
2737590|NCT00966992|Secondary|Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease||3 months after completion of treatment and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
2737591|NCT00966992|Secondary|If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood||At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
2737592|NCT00966992|Secondary|Change in Biochemical Markers of Bone Turnover||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
2737593|NCT00966992|Secondary|Change in Bone Mineral Density||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
2737594|NCT00966992|Primary|Incidence of Disseminated Tumor Cells in Bone Marrow||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
2737595|NCT00966992|Primary|Incidence of Circulating Tumor Cells (CTCs)||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
2737596|NCT00966953|Primary|Plaque Index|Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|8 weeks||||Units on a scale||Standard Deviation|Mean
2737597|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 6:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2737598|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 4:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2737599|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 2:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2737600|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 12:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2737601|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 10:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2737602|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 8:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2737603|NCT00966940|Primary|Mean Intraocular Pressure (IOP) at 8:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
2744164|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
2737604|NCT00966875|Secondary|Percentage of Participants With Anti-LY2439821 Antibodies|Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.|Week 16, Week 64|Part A (Week 16) FAS: all randomized participants who received at least 1 dose of study drug with antibody testing performed; Part B (Week 64): All participants from Part A who entered the open-label portion of the study, part B, with baseline and at least 1 post-baseline antibody testing.|||percentage of participants|||Number
2737605|NCT00966875|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State|Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).|Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6|All randomized participants who received at least 1 dose of study drug in Part A and had estimable PK data, as well as, participants from Part A who entered the open-label portion of the study, Part B, and had estimable PK data.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
2737606|NCT00966875|Secondary|Relationship Between Exposure and Response of EULAR28||Through Week 72|Relationship between exposure and response of EULAR 28 analysis was reported in OMs 22 and 23 as percentage of participants in EULAR28 (Parts A and B), respectively. No further analyses were completed for EULAR28.||||||
2737607|NCT00966875|Secondary|Relationship Between Exposure and Response of DAS28||Through Week 72|Relationship between exposure and response of DAS28 analysis was reported in OMs 6 and 7 as change from baseline in DAS28 (Parts A and B) respectively. No further analyses were completed for DAS28.||||||
2737608|NCT00966875|Secondary|Relationship Between Exposure and Response of ACR20/50/70/N||Through Week 72|Relationship between exposure and response ACR20/50/70/N analysis was reported in OMs 8 and 9, as percentage of participants with ACR 20/50/70 Response (Parts A and B) and OMs 24 and 25 as percentage of participants with ACR-N (Parts A and B) respectively. No further analyses were completed for ACR20/50/70/N.||||||
2737609|NCT00966875|Secondary|Relationship Between Exposure and Response of Individual Components of the ACR Core Set||Through Week 72|Relationship between exposure and response in Individual Components (IC) of ACR Core Set analysis was reported in outcome measures (OMs) 10-21 as change from baseline in IC of ACR Core Sets: TJC, SJC, PAAP-VAS, PtGADA-VAS, PhGA-VAS, and CRP (Parts A and B). No further analyses were completed for individual components of ACR Core Set.||||||
2737610|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part B|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 HAQ-DI results.|||units on a scale||Standard Deviation|Mean
2737611|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part A|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||units on a scale||Standard Deviation|Mean
2737612|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 Duration of Morning Stiffness results.|||minutes||Standard Deviation|Mean
2737613|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||minutes||Standard Deviation|Mean
2737634|NCT00966875|Secondary|Change From Baseline in DAS28 - Part B|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.|||units on a scale||Standard Deviation|Mean
2737614|NCT00966875|Secondary|Change From Baseline in FACIT Fatigue Scale - Part B|The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 FACIT results.|||units on a scale||Standard Deviation|Mean
2737615|NCT00966875|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A|The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, up to Week 12|Part A FAS: defined as all data from all randomized participants who received at least 1 dose of study drug LOCF.|||units on a scale||Standard Deviation|Mean
2737616|NCT00966875|Secondary|ACR-N - Part B|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.|||units on a scale||Standard Deviation|Mean
2737617|NCT00966875|Secondary|ACR-N - Part A|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.|||units on a scale||Standard Deviation|Mean
2737618|NCT00966875|Secondary|Percentage of Participants in EULAR28 - Part B|Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.|||percentage of participants|||Number
2737619|NCT00966875|Secondary|Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A|Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||percentage of participants|||Number
2737620|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.|||mg/L||Standard Deviation|Mean
2737621|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mg/L||Standard Deviation|Mean
2737622|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B|"The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.|||mm||Standard Deviation|Mean
2737623|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A|"The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mm||Standard Deviation|Mean
2737624|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.|||mm||Standard Deviation|Mean
2737625|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mm||Standard Deviation|Mean
2737626|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.|||mm||Standard Deviation|Mean
2737627|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mm||Standard Deviation|Mean
2737628|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.|||swollen joints||Standard Deviation|Mean
2737629|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||swollen joints||Standard Deviation|Mean
2737630|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.|||tender joints||Standard Deviation|Mean
2737631|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||tender joints||Standard Deviation|Mean
2737632|NCT00966875|Secondary|Percentage of Participants With of ACR20/50/70 Response - Part B|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.|||percentage of participants|||Number
2737633|NCT00966875|Secondary|Percentage of Participants With ACR20/50/70 Response - Part A|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2737675|NCT00966355|Primary|5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)||5 days after enrollment||||participants|||Number
2756611|NCT00831129|Secondary|Change in Triglycerides|change in Triglycerides between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
2737635|NCT00966875|Secondary|Change From Baseline in Disease Activity Score (DAS28)-Part A|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2737636|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population|ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||log (dose) mg|||Number
2737637|NCT00966875|Secondary|Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population|DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 − CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||log (dose) mg|||Number
2737638|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||log (dose) mg|||Number
2737639|NCT00966875|Secondary|Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population|ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.|||percentage of participants|||Number
2737640|NCT00966875|Primary|Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||percentage of participants|||Number
2737641|NCT00966849|Secondary|Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month||1 year||||Participants|||Count of Participants
2737642|NCT00966849|Primary|Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month||1 year||||Participants|||Count of Participants
2737643|NCT00966849|Primary|Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations||1 year||||Participants|||Count of Participants
2737644|NCT00966849|Primary|Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate||1 year||||Participants|||Count of Participants
2737645|NCT00966823|Secondary|Number of Participants With In Utero Lung Growth (LHR) >1.4|"Inclusion criterion for the study is LHR<0.9 (extreme pulmonary hypoplasia). Given that LHR is relatively constant during 2nd and 3rd trimester of gestation, In utero lung growth is defined as LHR>1.4 (definition of mild/moderate pulmonary hypoplasia) within 2 weeks of intervention.~Outcome measure = number of participants with LHR>1.4 at 2 weeks post-intervention"|Intervention to 2 weeks post-intervention||||Participants|||Number
2737646|NCT00966823|Secondary|Fetal Morbidity|Fetal morbidity, fetal mortality|Intervention to delivery||||Participants|||Number
2737647|NCT00966823|Secondary|Maternal Complications||Intervention to 30 days postpartum||||occurrences|||Number
2737648|NCT00966823|Secondary|Newborn Survival at 30 Days||30 days|1 of 2 enrolled participants (fetuses) survived until birth (Primary outcome). This 1 participant (infant) also survived at 30 days (secondary outcome).|||Participants|||Number
2737649|NCT00966823|Primary|Newborn Survival at Birth||Newborn period (1 day)||||Participants|||Number
2737650|NCT00966719|Secondary|Number of Mothers Seeking Breastfeeding Help||6 months|"50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module~49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module"|||Participants|||Count of Participants
2737651|NCT00966719|Secondary|Number of Physician Encounters in First 6 Months of Life||6 months||||physician encounters||Inter-Quartile Range|Mean
2737652|NCT00966719|Secondary|Number of Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life||6 months||||Participants|||Count of Participants
2737653|NCT00966719|Secondary|Number of Participants With an Infant Re-hospitalized for Jaundice||6 months||||Participants|||Count of Participants
2737894|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737654|NCT00966719|Secondary|Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely|Partial breastfeeding was defined as any amount of feeding breast milk|6 months|"50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module~49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module"|||Participants|||Count of Participants
2737655|NCT00966719|Secondary|Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely|Partial breastfeeding was defined as any feeding of breast milk|3 months||||Participants|||Count of Participants
2737656|NCT00966719|Secondary|Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely|Exclusive breastfeeding was defined as no milk intake other than breast milk|6 months|"50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module~49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module"|||Participants|||Count of Participants
2737657|NCT00966719|Primary|Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely|Exclusive breastfeeding was defined as no milk intake other than breast milk|3 months|"50 randomized to intervention; by 3 months 5 lost to follow up (45). By 6 months, 1 more patient lost to follow up (44), as reported in Participant Flow Module~49 randomized to control group; by 3 months 8 lost to follow up (41). By 6 months, 3 more patients lost to follow up (38), as reported in Participant Flow Module"|||Participants|||Count of Participants
2737658|NCT00966654|Secondary|Insulin Infusion Requirements||72 hours|The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with JHU IRB Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.||||||
2737659|NCT00966654|Primary|Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure||2 years|The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with Johns Hopkins University School of Medicine Institutional Review Board Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.||||||
2737660|NCT00966641|Primary|Area Under the Curve of Plasma Naproxen From 0 to t|Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.|30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.|Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.|||min×μg/mL||Full Range|Mean
2737661|NCT00966550|Primary|IL-6 Concentrations||6 hour postprandial study|Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.|||pg/mL||Standard Error|Least Squares Mean
2737662|NCT00966446|Secondary|Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization|Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.|Within 6 months|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization|||days||95% Confidence Interval|Median
2737663|NCT00966446|Primary|First Two Consecutive Sampling Periods Completed|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis|Within 2 months|These subjects sent in two consecutive swab samples starting with their first follow-up time point.|||participants|||Number
2737664|NCT00966446|Primary|Recurrent Infection|Confirmed new MRSA infections|Within 6 months|These study participants who self-reported re-infections of MRSA|||participants|||Number
2737665|NCT00966433|Secondary|Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.||up to 90 minutes||||breath/min||Standard Deviation|Mean
2737666|NCT00966433|Secondary|Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.||up to 90 minutes||||breath/min||Standard Deviation|Mean
2737667|NCT00966433|Secondary|Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.|Differences in respiratory rates between spontaneous ventilation and pressure support ventilation groups will be calculated by subtracting the mean of from the respiratory rates PSV group to the SV group.|up to 90 minutes||||breath/min||Standard Deviation|Mean
2737668|NCT00966433|Primary|Mean Values of Tidal Volume Between the PSV and PCV Groups|Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg|up to 90 minutes||||mL/kg||Standard Deviation|Mean
2737669|NCT00966433|Primary|Mean Values of ETCO2 Between the PSV and PCV Groups|Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg|up to 90 minutes||||mmHg||Standard Deviation|Mean
2737670|NCT00966433|Primary|Mean Tidal Volume Values Compared Between SV and PCV Groups|Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg|up to 90 minutes||||mL/kg||Standard Deviation|Mean
2737671|NCT00966433|Primary|Mean Values of ETCO2 in SV and PCV Groups|Mean Values of ETCO2 in SV and PCV groups reported in mmHg|up to 90 minutes||||mmHg||Standard Deviation|Mean
2737672|NCT00966433|Primary|Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.|Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. Measured in mL/Kg and will be calculated by subtracting the mean of tidal volume from the PSV group to the SV group|up to 90 minutes||||mL/kg||Standard Deviation|Mean
2737673|NCT00966433|Primary|Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.|Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups will be calculated by subtracting the mean of End-tidal Carbon Dioxide from the PSV group to the SV group|up to 90 minutes||||mmHg||Standard Deviation|Mean
2737674|NCT00966355|Secondary|Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects|at least one of the three criteria|5 days after enrollment||||participants|||Number
2737676|NCT00966277|Primary|Number of Participants With Venous Thromboembolic Events (VTE)|Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.|16 weeks of treatment||||participants|||Number
2737677|NCT00966264|Secondary|Depression||baseline, 6 and 12 months, 5 and 10 years||2010-05-31|05/2010||||
2737678|NCT00966264|Primary|Costs||baseline, 6 and 12 months, 5 and 10 years||2010-05-31|05/2010||||
2737679|NCT00966264|Primary|HRQoL (Health Related Quality of Life)|HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)|baseline and 5 years|The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups|||points on a scale||95% Confidence Interval|Mean
2737680|NCT00966238|Secondary|Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers||28 days after vaccination|The immunogenicity of the vaccine was evaluated by measuring the number of subjects who demonstrate seroconversion either by developing a measurable titer following vaccination or by showing a significant increase in HAI serum antibody titers post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2737681|NCT00966238|Primary|Number of Participants With Local and Systemic Immediate Reactogenicity Complaints||within 4 hours following vaccination|Immediate complaints were vaccination symptoms that were solicited and observed at 30 minutes (+15 minutes) and (±30 minutes) after the vaccination on Day 0.|||Participants|||Number
2737682|NCT00966186|Secondary|Insertion Time, Sealing Pressure and Complication||5 min - 4 hours|||||||
2737683|NCT00966186|Primary|Success of Insertion at First Attempt||5 minute||||participants|||Number
2737684|NCT00965848|Secondary|Number of Participants With 90-day Mortality|Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.|up to Day 90|"The cMITT included all participants who received any dose of study medication and met the clinical definition in the protocol. N” signifies those participants who were evaluated for this measure."|||Participants|||Number
2737685|NCT00965848|Secondary|Percentage of Participants With Clinical Response at Test-of-Cure (TOC)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).|Up to Day 14 after End-of-Treatment (EOT)|"The cMITT included all participants who received any dose of study medication. “N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of Participants|||Number
2737686|NCT00965848|Secondary|Percentage of Participants With Clinical Response at End-of-Treatment (EOT)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.|Up to Day 14 (EOT)|"Clinical Modified-Intent-to-Treat (cMITT) included all participants who received any dose of study medication. N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of participants|||Number
2737687|NCT00965848|Primary|Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs|An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.|Up to 30 days after last dose of study drug|Intent-to-treat population (ITT) included all participants who received at least one dose of study medication.|||Participants|||Number
2737688|NCT00965757|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)|||Percentage of Participants||95% Confidence Interval|Number
2737689|NCT00965757|Secondary|Percentage of ACR 70 Criteria Responders|ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||Percentage of Participants||95% Confidence Interval|Number
2737895|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737690|NCT00965757|Secondary|Percentage of ACR 50 Criteria Responders|ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)|||Percentage of Participants||95% Confidence Interval|Number
2737691|NCT00965757|Secondary|Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)|The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||participants|||Number
2737692|NCT00965757|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Assessment of individual ACR core components i.e. ESR|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||mm/hr||Standard Deviation|Mean
2737693|NCT00965757|Secondary|Change From Baseline in C-reactive Protein (CRP)|Assessment of individual ACR core components i.e. CRP|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||mg/dl||Standard Deviation|Mean
2737694|NCT00965757|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||score on scale||Standard Deviation|Mean
2737695|NCT00965757|Secondary|Change From Baseline in PAP, PtGADA and PyGADA|Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0-100 mm, with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||mm||Standard Deviation|Mean
2737696|NCT00965757|Secondary|Change From Baseline in Tender Joint Counts and Swollen Joint Counts|Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||joint counts||Standard Deviation|Mean
2737697|NCT00965731|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D.|Baseline up to 28 days (Cycle 1)|DLT evaluable population|||mg|||Number
2737698|NCT00965731|Other Pre-specified|Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment.|Baseline up to 28 days (Cycle 1)|DLT evaluable population|||mg|||Number
2737699|NCT00965731|Secondary|Percentage of Participants With Mutations in Tumor Tissue (Phase 2)|Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors.|Screening|Not analyzed due to phase 2 study termination||||||
2737700|NCT00965731|Secondary|Plasma Concentration of Erlotinib (Phase 2)|Plasma concentration of erlotinib when administered as a single agent during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose)|Not analyzed due to phase 2 study termination||||||
2737701|NCT00965731|Secondary|Plasma Concentration of PF-02341066 and Erlotinib (Phase 2)|Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose|Not analyzed due to phase 2 study termination||||||
2737702|NCT00965731|Secondary|EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination||||||
2737703|NCT00965731|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2|Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination||||||
2737704|NCT00965731|Secondary|Overall Survival (OS) at Phase 2|Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Baseline until death, up to 20 months|Not analyzed due to phase 2 study termination||||||
2737705|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 2)|Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination||||||
2737706|NCT00965731|Secondary|Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2|Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD.|Week 6 and Week 12|Not analyzed due to phase 2 study termination||||||
2737707|NCT00965731|Secondary|Duration of Response (Phase 2)|Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination||||||
2737708|NCT00965731|Secondary|Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination||||||
2737709|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination||||||
2737710|NCT00965731|Secondary|Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1)||Baseline and Day 50 (Cycle 3, Day 1)|Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability||||||
2737711|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)|Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50.|Baseline and Day 50 (Cycle 3, Day 1)|The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2737712|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 1)|Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2737713|NCT00965731|Secondary|Duration of Response (Phase 1)|Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of responses||||||
2737714|NCT00965731|Secondary|Progression-Free Survival (Phase 1)|"Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of study participants||||||
2737723|NCT00965731|Secondary|PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2737715|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||Ratio in percentage||90% Confidence Interval|Geometric Mean
2737716|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||Ratio in percentage||90% Confidence Interval|Geometric Mean
2737717|NCT00965731|Secondary|Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15).|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2737718|NCT00965731|Secondary|Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2737719|NCT00965731|Secondary|Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2737720|NCT00965731|Secondary|Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)|Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2737721|NCT00965731|Secondary|PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2737722|NCT00965731|Secondary|PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2737745|NCT00965562|Secondary|Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)|DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.|||proportion of participants|||Number
2737724|NCT00965731|Secondary|PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2737725|NCT00965731|Secondary|PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2737726|NCT00965731|Primary|Progression-Free Survival (Phase 2)|"Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination||||||
2737727|NCT00965731|Primary|Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)|Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).|Baseline up to Day 28|DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities)|||participants|||Number
2737728|NCT00965718|Primary|Progressive Disease(PD)|Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||number of participants|||Number
2737729|NCT00965718|Primary|Stable Disease(SD)|Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||number of participants|||Number
2737730|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)|QLQ-PAN26 consists of questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2737731|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)|QLQ-C30 constitutes a functional scale(physical, role, emotional, cognitive, and social functioning), symptom scores scale(fatigue, nausea/vomiting, pain, dyspnea, constipation, diarrhea, insomnia, appetite loss, financial difficulties), and global QoL scale. With the scores of all scales ranging from 0 to 100, a higher score indicates a better functional scale and a better global QoL scale as well as a worse symptom scores scale.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2737732|NCT00965718|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||weeks||95% Confidence Interval|Median
2737733|NCT00965718|Secondary|Overall Survival (OS)|OS was calculated from the date of enrollment until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).|Every visit, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||weeks||95% Confidence Interval|Median
2737746|NCT00965523|Secondary|Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.|Every 6 weeks|Full Analysis Set|||percentage of subjects|||Number
2737734|NCT00965718|Primary|Disease Control Rate|"Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.~Disease control rate = CR or PR or SD patients / ITT population *100"|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||percentage of participants||95% Confidence Interval|Number
2737735|NCT00965562|Primary|Comparison of the Change in CGI Improvement Scores Among Groups|CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on CGI Improvement scale||Standard Deviation|Mean
2737736|NCT00965562|Primary|Comparison of the Change in DRSP Symptom Scores Among Groups|DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on DRSP scale||Standard Deviation|Mean
2737737|NCT00965562|Primary|Comparison of the Change in CGI-S Symptom Scores Among Groups|CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on CGI-S scale||Standard Deviation|Mean
2737738|NCT00965562|Primary|Comparison of the Change in PMTS Symptom Scores Among Groups|PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on PMTS scale||Standard Deviation|Mean
2737739|NCT00965562|Primary|Comparison of the Change in IDS Symptom Scores Among Groups|IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on IDS scale||Standard Deviation|Mean
2737740|NCT00965562|Secondary|Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.|||proportion of participants|||Number
2737741|NCT00965562|Secondary|Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)|"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.~IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe)."|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.|||proportion of participants|||Number
2737742|NCT00965562|Secondary|Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. However, Visit 5 DRSP calendars were missing for an additional 3 subjects in the fluoxetine group and for one subject in each of the calcium and placebo cells.|||proportion of participants|||Number
2737743|NCT00965562|Secondary|Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)|PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.|||proportion of participants|||Number
2737744|NCT00965562|Secondary|Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)|IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.|||proportion of participants|||Number
2737747|NCT00965523|Primary|Number of Subjects With Adverse Events.||Every week during treatment and up to 30 days after last dose of study treatment|Safety Analysis Set|||Participants|||Number
2737748|NCT00965497|Secondary|McGill Quality of Life Scale (MQOL)|McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).|8 weeks||||quality of life||Full Range|Mean
2737749|NCT00965497|Primary|Hamilton Depression Scale (HAM-D 17).|Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.|8 weeks|Intention to Treat|||depression severity||Standard Deviation|Median
2737750|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; number of participants with measurement.|||percentage of dyads||95% Confidence Interval|Number
2737751|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS|||percentage of dyads||95% Confidence Interval|Number
2737752|NCT00965484|Secondary|Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; N=number of participants with measurement.|||percentage of dyads||95% Confidence Interval|Number
2737753|NCT00965484|Primary|Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|Full analysis set (FAS): all participants who used the new pen at least once to administer Genotropin and who completed the 2-month follow-up questionnaire. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).|||percentage of dyads||95% Confidence Interval|Number
2737754|NCT00965458|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c level of 5.6% or less is considered normal. HbA1c levels of 6.5% or higher is typical for individuals with Type 1 Diabetes Mellitus (T1DM). The closer HbA1c levels are to normal, the better controlled the disease is.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||HgbA1c percent (%)||Standard Deviation|Mean
2737755|NCT00965458|Secondary|Major Hypoglycemic Events Occurring From Randomization|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline to Week 52 and Week 52 to Week 104|Intent-to-treat|||Major Hypoglycemic Events|||Number
2737756|NCT00965458|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||Units per day divided by weight in kg||Standard Deviation|Mean
2737757|NCT00965458|Secondary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
2739135|NCT00957359|Primary|STAI State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|1 day prior to drug administration 1||||score on a scale||Standard Error|Mean
2737758|NCT00965458|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
2737759|NCT00965458|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (pre-treatment initiation), Week 52|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
2737760|NCT00965419|Secondary|Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)|The WAIS-III® was used in the participants aged 17 years or older. Comprehensive reporting on the participant's intellectual ability is not required in this study. Raw scores for each of the 14 subtests are reported. Raw score ranges for each subtest are as follows: picture completion (0-25), vocabulary (0-66), digit symbol coding (0-133), similarities (0-33), block design (0-68), arithmetic (0-22), matrix reasoning (0-26), digit span forward and backward total (0-30), information (0-28), picture arrangement (0-22), comprehension (0-33), symbol search (0-60), letter-number sequencing (0-21), and object assembly (0-52). Higher scores reflect better performance and lower scores reflect lower performance.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WAIS-III assessment.|||units on a scale||Standard Deviation|Mean
2737761|NCT00965419|Secondary|Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)|The fourth edition of the WISC assessment (WISC-IV®) is administered to children ranging from 6 years to 16 years, 11 months. It contains 10 core subtests and 5 supplementary subtests, and takes 65-80 minutes to complete. In this study, Digit Span and Letter-Number Sequencing subtests were completed. Scaled scores range from 1 to 19. Higher scores denote better performance. Lower scores denote worse performance.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WISC-IV assessment.|||units on a scale||Standard Deviation|Mean
2737762|NCT00965419|Secondary|Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)|The WRAT 4 is a norm-referenced test that measures the basic academic skills of word reading, sentence comprehension, spelling, and math computation. There are 2 alternate forms (Blue Form, Green Form) that can be used interchangeably with comparable results. It can be used to evaluate a person aged 5 to 94 years and the administration time is 30 to 45 minutes for children (8 years or older) and adults, and 15 to 25 minutes for young children (ages 5 to 7 years). The age-normed standard scores range from 55 - 145 and for each subtest/composite includes word reading, sentence comprehension, spelling, math computation and reading composite. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WRAT 4 assessment.|||units on a scale||Standard Deviation|Mean
2737763|NCT00965419|Secondary|Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])|The Woodcock Johnson (WJ III ACH) (Woodcock 2001) is designed to measure academic achievement and evaluates a person aged 2 to 90 years and the tool takes 60 to 160 minutes to complete depending on a person's academic level. The WJ III ACH has 2 parallel forms (A and B) that can be administered in an alternating fashion. The WCJ III ACH uses standard scores (Deviation IQ) with an average standard score of 100 and a standard deviation of 15. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WJ III ACH assessment.|||units on a scale||Standard Deviation|Mean
2737764|NCT00965419|Secondary|Mean Change From Baseline of Total Score EQ-5D-3L VAS|"EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 or being worst imaginable health state. Participants aged 12 years or older rated their own health-related quality of life using the EQ-5D-3L VAS scale."|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
2737798|NCT00965419|Primary|Number of Participants With At Least One SAE|Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment.|||Participants|||Count of Participants
2737991|NCT00963872|Secondary|Bone Marrow Chimerism|Percentage of donor DNA in the bone marrow.|Day 21|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
2737765|NCT00965419|Secondary|Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent|EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Participants aged 12 years or older rate their own health-related quality of life using EQ-5D-3L.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L assessment.|||units on a scale||Standard Deviation|Mean
2737766|NCT00965419|Secondary|Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child|"EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 being worst imaginable health state. Parents of the participants aged 6 to 11 years complete the EQ-5D-3L form for rating the participants health-related QoL, EQ-5D-3L. i.e., the young child was unable to assess their own quality of life then the parent assessed the child's quality of life."|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
2737767|NCT00965419|Secondary|Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child|The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. Parents of the participants aged 6 to 11 years completed the EQ-5D-3L form regarding the participants health-related quality of life. i.e., young children were unable to assess their own quality of life so the parents assessed the child's quality of life for them.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L assessment.|||units on a scale||Standard Deviation|Mean
2737768|NCT00965419|Secondary|Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent|"The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 being worst imaginable health state. Parents of the participants complete EQ-5D-3L form for rating their own health."|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|Parents of the participants completed the EQ-5D-3L form for rating their own quality of life, for parents of participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
2737769|NCT00965419|Secondary|Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life (QoL) instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Parents of the participants completed the EQ-5D-3L form for rating their own quality of life.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|Parents of the participants completed the EQ-5D-3L form for rating their own quality of life, for parents of participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
2737770|NCT00965419|Secondary|Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)|CHIP-CE Parent Report Form (PRF) is a parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 156|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CHIP-CE assessment.|||T-score||Standard Deviation|Mean
2737799|NCT00965419|Primary|Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study|Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment.|||percentage of participants|||Number
2737771|NCT00965419|Secondary|Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)|CHIP-AE Child Report Form (CRF) is an adolescent rated assessment of their health status and level of functioning. The items in the 5 domains include: Achievement, Satisfaction, Comfort, Risk Avoidance, and Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 156|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CHIP-AE assessment.|||T-score||Standard Deviation|Mean
2737772|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)|CP-CBRS is a comprehensive assessment of a wide spectrum of behaviors, emotions, and academic problems in children and adolescents. It includes DSM-IV-TR symptom scales, empirical and rational scales, other clinical indicators and critical and impairment items. DSM-IV-TR symptom scales assess ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age self-report form (179-item). The parent form of Conners CBRS (CP-CBRS) was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||T-score||Standard Deviation|Mean
2737773|NCT00965419|Secondary|Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Schoolwork/grades, friendships/relationships, home life functioning scores range from 0=never to 3=very often. Raw scores are presented for each subscale with higher scores indicating higher severity and lower scores indicating lower severity.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||units on a scale||Standard Deviation|Mean
2737774|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||T-score||Standard Deviation|Mean
2737775|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||T Score||Standard Deviation|Mean
2737800|NCT00965341|Secondary|The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).|The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0-10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression.|Day 29 (+/- 3 days)||||units on a scale||Standard Deviation|Mean
2744165|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
2737776|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.|Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment. No data was available for mixed episode due to not part of the statistical analysis plan..|||T-score||Standard Deviation|Mean
2737777|NCT00965419|Secondary|Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale|"The SNAP-IV ODD subscale includes items #21 to #28. Each item is scored on a 0 to 3 scale (0 = Not At All, 1 = Just A Little, 2 = Pretty Much, 3 = Very Much). Score ranges from 0-24. The lowest possible score is 0; highest is 24. Higher scores indicate a greater presence of ODD and lowers scores a lower presence of ODD."|Baseline, Week 12|All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.|||units on a scale||Standard Deviation|Mean
2737778|NCT00965419|Secondary|Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)|The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire (Swanson et al 1983). The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of inattention and higher scores a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of hyperactivity/impulsivity and higher scores, a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity.|Baseline, Week 12|All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.|||units on a scale||Standard Deviation|Mean
2737779|NCT00965419|Secondary|Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)|The CGI-ADHD-S measures severity of the participants overall severity of ADHD symptoms. The score ranges from 1 to 7 (1=normal, not at all ill; 7=among the most extremely ill participants). LS mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CGI-ADHD-S assessment.|||units on a scale||Standard Error|Least Squares Mean
2737780|NCT00965419|Secondary|Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)|The ADHDRS-IV-Parent scale measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the 18 items and ranges from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subscale scores ranging from 0 to 27. Higher total and subscale scores are indicative of more severe symptoms. Least-squares (LS) mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline ADHDRS-IV-Parent assessment.|||units on a scale||Standard Error|Least Squares Mean
2737781|NCT00965419|Secondary|Number of Participants With Tobacco, Alcohol and Marijuana Use||Week 60 through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline tobacco, alcohol, and marijuana use assessment.|||Participants|||Count of Participants
2737782|NCT00965419|Secondary|Percentage of Participants With Tobacco, Alcohol and Marijuana Use||Week 60 through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline tobacco, alcohol, and marijuana use assessment.|||percentage of participants|||Number
2737783|NCT00965419|Secondary|Number of Participants in Sexual Maturation on Tanners Scale|Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|Baseline Up to Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Tanners scale assessment.|||Participants|||Count of Participants
2737784|NCT00965419|Secondary|Percentage of Participants in Sexual Maturation on Tanners Scale|Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|Baseline Up to Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Tanners scale assessment.|||percentage of participants|||Number
2737785|NCT00965419|Secondary|Survival Curve Time to Response||Week 12|Zero participants were analyzed for this outcome measure. Data was not collected for this outcome for participants due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636]). This outcome measure was not applicable to roll-over participants.||||||
2737786|NCT00965419|Secondary|Number of Participants With a Response Rate||Week 12|Zero participants were analyzed for this outcome measure. Data was not collected for this outcome for participants due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636]). This outcome measure was not applicable to roll-over participants.||||||
2737787|NCT00965419|Secondary|Percentage of Participants With Response Rates||Week 12|Zero participants were analyzed for this outcome measure, due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636])This outcome measure and analysis was not applicable to roll-over participants.||||||
2737788|NCT00965419|Secondary|Mean Change From Baseline Z-Score in Body Mass Index (BMI)||Baseline, Week 60; Baseline, Week 240|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.|||Z-Score||Standard Deviation|Mean
2737789|NCT00965419|Secondary|Mean Change From Baseline Z-Score for Weight|A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).|Baseline, Week 60; Baseline, Week 240|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.|||Z-Score||Standard Deviation|Mean
2737790|NCT00965419|Secondary|Mean Change From Baseline Z-scores for Height|A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).|Baseline, Week 60; Baseline, Week 240|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.|||Z-Score||Standard Deviation|Mean
2737791|NCT00965419|Secondary|Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category|Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide.|Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CSSRS assessment.|||percentage of participants|||Number
2737792|NCT00965419|Secondary|Number of Participants Who Discontinued Due to Any Reason||Baseline Through Week 252|All enrolled participants who had evaluable discontinuation data.|||Participants|||Count of Participants
2737793|NCT00965419|Secondary|Percentage of Participants Who Discontinued Due to Any Reason||Baseline Through Week 252|All enrolled participants who had evaluable discontinuation data.|||Percentage of participants|||Number
2737794|NCT00965419|Secondary|Number of Participants With At Least One DCAEs||Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline DCAE assessment.|||Participants|||Count of Participants
2737795|NCT00965419|Secondary|Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)||Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation.|||percentage of participants|||Number
2737796|NCT00965419|Secondary|Number of Participants With At Least One TEAE|Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment.|||Participants|||Count of Participants
2737797|NCT00965419|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment.|||percentage of participants|||Number
2737817|NCT00965185|Secondary|Lipid Profile|12 month change in lipid profile|Measured at baseline and 1 year|All available data were used.|||mmol/L||95% Confidence Interval|Mean
2737801|NCT00965341|Primary|Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)|The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.|Day 29 (+/- 3 days)||||units on a scale||Standard Deviation|Mean
2737802|NCT00965263|Secondary|Plasma Cocaine|Plasma cocaine levels in Week 3 and Week 13 as a function of cocaine dose in High and Low AB groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher plasma levels of cocaine.|13 weeks|Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received.|||ng/mL||Standard Error|Mean
2737803|NCT00965263|Secondary|Cocaine Cardiovascular Effects|Heart rate levels in Week 3 and Week 13 as a function of cocaine dose in High and Low antibody groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher heart rates.|13 weeks|Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received.|||BPM||Standard Error|Mean
2737804|NCT00965263|Primary|Cocaine Intoxication|"Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster (Good Drug Effect, High, Stimulated) over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements."|13 weeks|Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received.|||units on a scale||Standard Error|Mean
2737805|NCT00965250|Secondary|Correlate Response to Therapy With Changes in FDG-PET Imaging|Participants with scans that showed neither sufficient shrinkage to qualify as an objective response nor sufficient increase to qualify as disease progression, taking as reference the smallest cumulative longest dimension since start of treatment, to have stable disease.|6 weeks after initiation of treatment|We did radiological assessment ourselves, and an independent radiological assessment was not undertaken for assessment of response or progression.||||||
2737806|NCT00965250|Secondary|Median Number of Cycles of Therapy|A cycle is defined as 21 days or 6 weeks of therapy.|6 weeks||||Cycles||Full Range|Median
2737807|NCT00965250|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|39 months||||Months||95% Confidence Interval|Median
2737808|NCT00965250|Secondary|Time to Progression|Time between the first day of treatment to the day of disease progression.|39 months||||Months||95% Confidence Interval|Median
2737809|NCT00965250|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as objective response plus stable disease.|39 months||||percentage of participants||95% Confidence Interval|Number
2737810|NCT00965250|Secondary|Percentage of Participants Who Respond to Treatment|Percentage of participants who respond to treatment was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|39 months||||percentage of participants||95% Confidence Interval|Number
2737811|NCT00965250|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|81 months and 17 days|Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups.|||Participants|||Number
2737812|NCT00965250|Primary|Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma.|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug.||||Participants|||Number
2737813|NCT00965237|Primary|Overall Satisfaction With the Lenses|Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.|1 week of wear|Analysis conducted per protocol|||Units on a Scale||Standard Deviation|Mean
2737814|NCT00965185|Secondary|Liver Function Tests (LFTs)|"Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).~For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.~ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L"|Measured at baseline, 1, 3, 6, 9, and 12 months|All available data were used.|||participants|||Number
2737815|NCT00965185|Secondary|Adipocytokines|12 month change in IL-6|Measured at baseline and 1 year||||pg/ml||95% Confidence Interval|Mean
2737816|NCT00965185|Secondary|C-reactive Protein (CRP)|12 month change in Log CRP concentration|Measured at baseline and 1 year|All available data were used.|||log(mg/L)||95% Confidence Interval|Mean
2737821|NCT00965185|Primary|Coronary and Aortic Plaque Inflammation|12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)|Measured at baseline and 1 year|All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included.|||ratio||95% Confidence Interval|Mean
2737822|NCT00965146|Primary|Evaluate Complication Rate.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years|||||||
2737823|NCT00965146|Primary|Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years|||||||
2737824|NCT00965094|Secondary|Change in Renal Function (Creatinine Slope)|X(slope)=(1/value of creatinine).|3 months, 5 months, 7 months, 9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).|||mg/dl per month||Standard Deviation|Mean
2737825|NCT00965094|Secondary|Participants Who Had Occurrence of Treatment Failure.|Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method)|||Participants|||Number
2737826|NCT00965094|Secondary|Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death.|Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable|||Participants|||Number
2737827|NCT00965094|Secondary|Assessment of GFR by the Cockcroft-Gault Method (LOCF)|the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight[kg]/72X Serum Creatinine[mg/dl] For women: GFR= 0,85x(140-Age) x Body Weight[kg]/72x Serum Creatinine [mg/dl] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable|||mL/min||Standard Deviation|Mean
2737828|NCT00965094|Primary|Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF)|The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).|||mL/min/1.73m^2||Standard Deviation|Mean
2737829|NCT00965081|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.~Suicidal behavior: a yes answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.~Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation."|Baseline through 12 weeks|Only participants having at least 1 post-baseline C-SSRS assessment were included in this analysis.|||Participants|||Number
2737830|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)|SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2737831|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)|"The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.~The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline."|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
2744166|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
2737832|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per randomly assigned groups. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy(DB) due to adverse event; last non-missing observation during initial DB used to impute the missing endpoint for all others.|||Units on a scale||Standard Error|Least Squares Mean
2737833|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
2737834|NCT00965081|Secondary|Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint|"The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).~The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
2737835|NCT00965081|Secondary|Patient Global Impression - Improvement (PGI-I) at Endpoint|"The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is very much better, 4 is no change, and 7 is very much worse. Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
2737836|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form|BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The LOCF method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
2737837|NCT00965081|Primary|"Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.|Baseline, 12 weeks|Intent-to-treat (ITT) population: all randomized participants. ITT treatment group is group to which participant was randomized regardless of treatment actually received. BOCF method used to impute endpoint value if initial DBT discontinued due to AE. Change from baseline analyses included all those with baseline and ≤1 post-baseline observation.|||Units on a scale||Standard Error|Least Squares Mean
2737838|NCT00965055|Secondary|LDL-C Reduction as Well as Changes in TG, HDL, and Non-HDL Cholesterol.||24 weeks|Study was not analyzed as only 2 subjects were enrolled and the study was terminated due to lack of enrollment.||||||
2737839|NCT00965055|Primary|LDL-C Reduction|Study was not analyzed as only 2 subjects were enrolled and the study was terminated due to lack of enrollment.|6 weeks|Study was not analyzed as only 2 subjects were enrolled and the study was terminated due to lack of enrollment.||||||
2737840|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive cognitive behavioral therapy or to no cognitive behavioral therapy (behavioral effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores|||Units on a scale.||Standard Error|Mean
2737873|NCT00964496|Primary|Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months|The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Reduction of rebleeds = [(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.|baseline and 12 months||||participants|||Number
2737841|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to cognitive behavioral therapy to or no behavior therapy comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.|||units on a scale||Standard Error|Mean
2737842|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive desipramine hydrochloride or benztropine mesylate (drug effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores|||Units on a scale.||Standard Error|Mean
2737843|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to desipramine or to active drug placebo (benztropine) comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.|||units on a scale||Standard Error|Mean
2737844|NCT00964860|Secondary|Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|"Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).~Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.~The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites)."|30 days|per protocol|||units on a scale||Standard Error|Least Squares Mean
2737845|NCT00964860|Primary|Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation|30 days|per protocol|||units on a scale||Standard Error|Mean
2737846|NCT00964795|Other Pre-specified|Summary of Study Duration (Weeks)|Study Duration = (last visit/ discontinuation date - first dose date + 28)/7|Baseline through end of treatment (Week 180)||||weeks||Standard Deviation|Mean
2737847|NCT00964795|Other Pre-specified|Summary of Treatment Duration (Weeks)|Treatment Duration = (last dose date - first dose date + 28)/7|Baseline through end of treatment (Week 180)||||weeks||Standard Deviation|Mean
2737848|NCT00964795|Secondary|Change in BCVA Letter Score (mLOCF)|"The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.~(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward)."|Baseline through Week 116||||letters correctly read||Standard Deviation|Mean
2737849|NCT00964795|Primary|Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD|"The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).~Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs"|Baseline (day 1) through end of treatment (Week 180)||||participants|||Number
2737850|NCT00964782|Secondary|The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).|A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute|Baseline to 1 hour||||Mets||Standard Error|Mean
2737851|NCT00964782|Secondary|The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.|A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test|Baseline to 1 Hour||||Percentage of oxygen saturation||Standard Error|Mean
2737852|NCT00964782|Secondary|The Change in Exercise Capacity Measured Via Maximum Heart Rate|A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test|Baseline to 1 Hour||||beats per minute||Standard Error|Mean
2737853|NCT00964782|Primary|The Change in Exercise Capacity Measured Via Exercise Time|A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test|baseline to 1 hour||||minutes||Standard Error|Mean
2737854|NCT00964782|Primary|The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)|A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test|baseline to 1 hour||||ml/min/kg||Standard Error|Mean
2737855|NCT00964743|Secondary|CSF and Serum Vascular Endothelial Growth Factor (VEGF) Levels|CSF and serum VEGF levels were to be measured over time, and the means and standard errors of the respective VEGF levels were to be plotted at specific sampling time points. The respective VEGF levels may also have been correlated with patients' PFS, OS, or cytology using descriptive statistical methods similarly as mentioned above. The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
2737856|NCT00964743|Secondary|Sorafenib Levels in Cerebrospinal Fluid (CSF)|CSF sorafenib level was to be measured over time, and the means and standard errors of the sorafenib level were to be plotted at specific sampling time points. CSF sorafenib levels may also have been correlated with patients' PFS, OS, or cytology using descriptive statistical methods (e.g., KM analysis stratified by high vs. low CSF sorafenib levels). The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
2737857|NCT00964743|Secondary|Number of Participants With Overall Survival (OS)|Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
2737858|NCT00964743|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Kaplan-Meier analysis of PFS was to be performed and the PFS at 6 months in the study patients were be empirically described. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
2737859|NCT00964743|Primary|Number of Participants With Adverse Events (AEs)|Safety and tolerability of sorafenib with DepoCyt. Toxicities were to be reported using tables and descriptive statistics by type and grade. All patients were to be followed up until death.|6 Months|All participants|||participants|||Number
2737860|NCT00964678|Secondary|Change in Tricuspid Annular Plane Systolic Excursion|Higher values indicate a better outcome.|baseline and 6 months|The patient excluded from the analysis was unable to be present for the final echo-cardiogram due to lack of transportation and distance from the hospital. Multiple attempts to schedule the study test were made through phone and email.|||centimeters|||Number
2737861|NCT00964678|Secondary|Change in 6 Minute Walk Distance||baseline and 6 months|The patient who was excluded from analysis developed an orthopedic injury during the study and was unable to complete the walking test at conclusion of the study|||feet|||Number
2737862|NCT00964678|Secondary|Change in Right Ventricular End Systolic Volume|right ventricular end systolic volume determined by MRI|baseline and 6 months||||mL|||Number
2737863|NCT00964678|Primary|Absolute Change in Right Ventricular Ejection Fraction|Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only|baseline, 6 months|Patients with right heart catheterization confirmed pulmonary arterial hypertension, already on pulmonary vasodilator therapy|||% RVEF||95% Confidence Interval|Mean
2737864|NCT00964548|Secondary|Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion||||cm/s||95% Confidence Interval|Mean
2737865|NCT00964548|Secondary|Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion||||cm/s||95% Confidence Interval|Mean
2737866|NCT00964548|Primary|Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion||||mmHg||95% Confidence Interval|Mean
2737867|NCT00964496|Primary|Cessation of Bleeding|The cessation of bleeding was defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding was defined based on a positive FOBT at any visit after treatment.|52 months||||participants|||Number
2737868|NCT00964496|Secondary|Change From Baseline in Total Transfused Red Cell Requirements at 12 Months|Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients|baseline and 12 months|There are 14 participants depended on blood transfusion in each group|||milliliter||Standard Deviation|Mean
2737869|NCT00964496|Secondary|Participants Dependent on Blood Transfusions|Numbers of participants dependent on blood transfusions|52 months|55 patients were enrolled in our study. One in iron-controlled group refused to continue for personal reason after 8 months, two other in thalidomide plus iron group refused to take study medications after 4 weeks treatment due to leukopenia and unexplained somnolence. Analysis was performed according to Intention-to-Treat principle.|||participants|||Number
2737870|NCT00964496|Secondary|Change From Baseline in Bleeding Duration at 12 Months|The change from baseline in bleeding duration at 12 months|baseline and 12 months||||days||Standard Deviation|Mean
2737871|NCT00964496|Secondary|Change From Baseline in Bleeding Episodes at 12 Months|The Change from baseline in bleeding episodes at 12 months|baseline and 12 months||||bleeding episodes||Standard Deviation|Mean
2737872|NCT00964496|Secondary|Change From Baseline in Hemoglobin (Hb) Level at 12 Months|The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months.|baseline and 12 months||||g/L||Standard Deviation|Mean
2737875|NCT00964431|Primary|Total Patient Pain Relief Over 0 to 8 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32."|8 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
2737876|NCT00964392|Secondary|Percentage of Subjects Experienced Serious Adverse Events.|The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).|First study day to 5 year post-ablation|Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one SAE, was excluded from this analysis since the subject discontinued prior to RF ablation.|||percentage of participants|||Number
2737877|NCT00964392|Primary|The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.|The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.|Seven days post ablation procedure|Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one primary AE, was excluded from this analysis since the subject discontinued prior to RF ablation.|||percentage of participants||95% Confidence Interval|Number
2737878|NCT00964366|Secondary|Skin Hydration|Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.|2 weeks|ITT|||Microsiemens||Standard Deviation|Mean
2737879|NCT00964366|Secondary|Sebum Measurements|To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.|2 weeks|ITT|||units on a scale||Standard Deviation|Mean
2737880|NCT00964366|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1through Day 14|ITT|||Units on a scale||Standard Deviation|Mean
2737881|NCT00964366|Secondary|Transepidermal Water Loss (TEWL)|To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.|2 Weeks||||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
2737882|NCT00964366|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|2 Weeks|ITT|||Units on a scale||Standard Deviation|Mean
2737883|NCT00964353|Secondary|Supratherapeutic Dosing|International Normalized Ratio|during hospital stay, up to 60 days||||ratio||Standard Deviation|Mean
2737884|NCT00964353|Primary|Inpatient Length of Stay|Inpatient length of stay|during hospital stay, up to 60 days||||days||Standard Deviation|Mean
2737885|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737886|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737887|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 8|ITT. All participants were asked to respond to the questionnaire.|||Units on a scale||Standard Deviation|Mean
2737888|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 1, Week 2|ITT. All participants were asked to respond to the questionnaire.|||Units on a scale||Standard Deviation|Mean
2737889|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 8|ITT|||Participants|||Number
2737896|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737897|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737898|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?|Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.|Week 1, Week 2|ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.|||Participants|||Number
2737899|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737900|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737901|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737902|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737903|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737904|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737905|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737906|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737907|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737908|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737909|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737910|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737911|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737912|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737913|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Global Score|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737992|NCT00963872|Secondary|Overall Survival|Survival (alive) from transplantation to last follow-up.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2756612|NCT00831129|Secondary|Change in Low-density Lipoprotein|change in low-density lipoprotein between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
2737914|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Functional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737915|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Emotional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737916|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Symptomatic Domain|"Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737917|NCT00964223|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Week 5, Week 8|ITT|||total acne lesions||Standard Deviation|Mean
2737918|NCT00964223|Secondary|Non-Inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Week 5, Week 8|ITT|||non-inflammatory acne lesions||Standard Deviation|Mean
2737919|NCT00964223|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Week 5, Week 8|ITT|||inflammatory acne lesions||Standard Deviation|Mean
2737920|NCT00964223|Secondary|Investigator Static Global Assessment Score|ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737921|NCT00964223|Secondary|Irritant/Allergic Contact Dermatitis Score|Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737922|NCT00964223|Secondary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737923|NCT00964223|Secondary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737924|NCT00964223|Secondary|Erythema (Redness) Score|Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2737925|NCT00964223|Primary|Erythema (Redness) Score|Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737926|NCT00964223|Primary|Irritant/Allergic Contact Dermatitis Score|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face.~Erythema,peeling, and dryness were graded using the following scale:~0 None~Slight~Moderate~Intense"|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737927|NCT00964223|Primary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
2737928|NCT00964223|Primary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|Intent-to-Treat (ITT) Population|||Units on a scale||Standard Deviation|Mean
2737929|NCT00964158|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737930|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737931|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737932|NCT00964158|Secondary|Number of Subjects With Normal or Abnormal Biochemical Levels|Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.|At Days 0, 21 and 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737933|NCT00964158|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737934|NCT00964158|Secondary|Number of Subjects With Any Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2737935|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2737936|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2737937|NCT00964158|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
2737938|NCT00964158|Secondary|Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies|A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.|At Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737939|NCT00964158|Secondary|Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies|A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
2737940|NCT00964158|Secondary|Titers for Serum Neutralizing Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.|At Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
2737941|NCT00964158|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.|At Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737942|NCT00964158|Secondary|Titers for Serum Neutralizing Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Titers||95% Confidence Interval|Geometric Mean
2737943|NCT00964158|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
2737944|NCT00964158|Secondary|Seroconversion Factor (SCF) for HI Antibody Titers|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Fold increase||95% Confidence Interval|Geometric Mean
2737945|NCT00964158|Secondary|Number of Seroprotected Subjects in Terms of HI Antibodies|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Days 0, 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737946|NCT00964158|Secondary|Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies|A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.|At Days 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737947|NCT00964158|Secondary|Titers for Serum HI Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Days 0, 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
2737948|NCT00964158|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.|At Days 0, 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
2737949|NCT00964158|Primary|Seroconversion Factor (SCF) for HI Antibody Titers|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Fold increase||95% Confidence Interval|Geometric Mean
2737950|NCT00964158|Primary|Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
2737951|NCT00964158|Primary|Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies|A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
2737952|NCT00964158|Primary|Titers for Serum HI Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Titers||95% Confidence Interval|Geometric Mean
2737993|NCT00963872|Secondary|Non-Relapse Mortality|Deaths not due to relapse.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737953|NCT00964158|Primary|Titers for Serum HI Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Titers||95% Confidence Interval|Geometric Mean
2737954|NCT00964158|Primary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
2737955|NCT00964158|Primary|Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
2737956|NCT00964119|Primary|Skeletal Toxicities Related to the Use of Isotretinoin|Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy|Baseline to 5 months post therapy|Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.|||U/L||Standard Deviation|Mean
2737957|NCT00964028|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (from Day 0 until Month 3 or Month 4)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2737958|NCT00964028|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2737959|NCT00964028|Primary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2737960|NCT00964028|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2737961|NCT00963937|Secondary|Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment|Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting).|within 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the observed case dataset, a dataset without any imputation of missing data.|||percentage of participants|||Number
2737962|NCT00963937|Secondary|Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment|"Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as absent at each time point in his or her patient diary. Vomiting was recorded as present for all subsequent assessments if a participant took a rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had vomiting at the time of treatment were included in the denominator.|||percentage of participants|||Number
2737963|NCT00963937|Secondary|Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as absent at each time point in his or her patient diary. Nausea was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had nausea at the time of treatment were included in the denominator.|||percentage of participants|||Number
2737994|NCT00963872|Secondary|Incidence of Grades II-IV Graft-vs-host Disease|Development of graft-versus-host disease through day 100.|Day 0 through Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737995|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 28|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
2737964|NCT00963937|Secondary|Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Phonophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had phonophobia at the time of treatment were included in the denominator.|||percentage of participants|||Number
2737965|NCT00963937|Secondary|Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Photophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had photophobia at the time of treatment were included in the denominator.|||percentage of participants|||Number
2737966|NCT00963937|Secondary|Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment|Pain free was defined as a post-treatment pain intensity score of 1 on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took a rescue medication. The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 =mild, 3=mild to moderate, 4=moderate to severe, and 5=severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.|||percentage of participants|||Number
2737967|NCT00963937|Secondary|Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.|||percentage of participants|||Number
2737968|NCT00963937|Primary|Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|120 minutes post-treatment (Randomization through Final Visit [Week 6])|Full Analysis Set (FAS): all participants in the Safety Population (all participants who took >=1 dose of investigational product [IP]) who provided any post-treatment efficacy assessment. Analysis was performed on the last observation carried forward (LOCF) dataset (imputed by LOCF method). Only post-treatment values were used for imputation.|||percentage of participants|||Number
2737969|NCT00963924|Secondary|Side Effects Checklist (SEC)|Each side effect is entered as either yes or no for having had any severity of the side effect at each visit.|Weeks 0 - 8, and Month 6 after cognitive remediation completion|18 participants in each arm had baseline data available for analysis. At week 8, 17 participants in the D-cycloserine group and 15 in the placebo group had data available. At month 6, 6 participants in the D-cycloserine group and 4 in the placebo group had data available.|||Participants|||Count of Participants
2737970|NCT00963924|Secondary|Clinical Global Impression (CGI)|"Considering you total clinical experience with this patient population, how mentally ill is the patient at this time?~1=Normal, not at all, 2=Borderline mentally ill, 3=Mildy ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, 7=Among the most extremely ill patients; a higher score indicates worse outcome"|Weeks 0 and 8, and Month 6 after cognitive remediation completion|18 participants in each arm had baseline data available for analysis. At week 8, 17 participants in the D-cycloserine group and 15 in the placebo group had data available. At month 6, 6 participants in the D-cycloserine group and 4 in the placebo group had data available.|||units on a scale||Standard Deviation|Mean
2737971|NCT00963924|Secondary|Calgary Depression Scale for Schizophrenia (CDSS)|Baseline scores on the Calgary Depression Scale for Schizophrenia (CDSS). Total CDSS scores range from 0-27. The assessment is comprised of 9 questions covering the topics of Depression, Hopelessness, Self Depreciation, Guilty Ideas of Reference, Pathological Guilt, Morning Depression, Early Wakening, Suicide, Observed Depression. Each item is scored on a scale from 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The total score is computed by adding up the individual scores of each item. The higher the score, the more prominent the symptoms of depression are for the participant.|Baseline||||units on a scale||Standard Deviation|Mean
2737972|NCT00963924|Secondary|Heinrich Quality of Life Scale (QoL)|Baseline scores of the Heinrich Quality of Life Scale, a 21 item scale designed and validated to measure intrapsychic foundations, interpersonal relations, instrumental role, and common objects and activities in patients diagnosed with Schizophrenia. Patients are rated on each of the 21 items on a scale of 0-6. Total scores are computed by adding up the scores of each individual item, with a total score ranging from 0-126. Higher scores reflect higher functioning.|Baseline||||units on a scale||Standard Deviation|Mean
2737973|NCT00963924|Secondary|Global Assessment of Functioning Scale (GAS)|The Global Assessment of Functioning Scale (GAS) measured at baseline. This scale measures social, occupational, and psychological functioning, on a scale of 0-100. The higher the score, the greater a participant's functioning level.|Baseline||||units on a scale||Standard Deviation|Mean
2737996|NCT00963872|Secondary|Neutrophil Engraftment|Achieving 500 neutrophils/uL by day 42.|Day 42|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737974|NCT00963924|Secondary|Positive and Negative Syndrome Scale (PANSS)|The baseline score on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. The higher a score the more prominent a positive symptom is.|Baseline||||units on a scale||Standard Deviation|Mean
2737975|NCT00963924|Primary|Auditory Discrimination Task: Interstimulus Interval (ISI)|The auditory discrimination task involved trials in which the subject differentiated between rapidly-presented frequency-modulated sweeps separated by a short interstimulus interval (ISI). In this task, sustained successful performance is more difficult with shorter stimulus presentations and ISIs (which were equal within a trial). Thus, our dependent measure was the shortest stimulus duration/ISI, in ms, for trials in which subjects were able to perform the task at 85% accuracy, referred to as ISI for simplicity. The shorter the score the better the performance on the task. Scores are reported for baseline and week 8.|Baseline vs. Week 8|18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.|||milliseconds||Standard Deviation|Mean
2737976|NCT00963924|Primary|Scale for Assessment of Negative Symptoms (SANS)|The total scores from baseline and week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores are reported for baseline and week 8.|Baseline vs. Week 8|18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.|||units on a scale||Standard Deviation|Mean
2737977|NCT00963924|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed on a normative scale into t-scores, and then these scores are combined to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.|Baseline vs. Week 8|18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.|||t-scores||Standard Deviation|Mean
2737978|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
2737979|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
2737980|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
2737981|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737982|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737983|NCT00963872|Secondary|Overall Survival at Day 720|Survival (alive) from transplantation to last follow-up at day 720.|720 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737984|NCT00963872|Secondary|Non-relapse Mortality|Deaths not due to relapse.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737985|NCT00963872|Secondary|Incidence of Grades III-IV Graft-vs-host Disease|Development of graft-versus-host disease by day 100.|0 to 100 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737986|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 60|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
2737987|NCT00963872|Secondary|Platelet Recovery|Number of patients with >20,000 platelets/uL by day 180|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737988|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737989|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737990|NCT00963872|Secondary|Chronic Graft-Versus-Host Disease|Patients who developed chronic graft-versus-host disease.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737997|NCT00963872|Primary|Number of Patients With the Complement 3a (C3a) Unit Predominating|Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
2737998|NCT00963859|Primary|Overall Percentage Median Yield|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.|3 months including surgery and post-operative period.||||Percentage of Nodes (Node Yield)|||Number
2737999|NCT00963859|Primary|Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.|3 months including surgery and post-operative period.||||Nodes (Node Yield)||Full Range|Median
2738000|NCT00963820|Primary|Neurotoxicity Grading|Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.|Cycle 1 Day 1 and End of Study (Up to 354 days)|Safety Population included all randomized participants who received study drug.|||score on a scale||Standard Deviation|Mean
2738001|NCT00963820|Secondary|Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time|"Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~Partial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas.~Minimal Response (MR)= 25-49% reduction in serum paraprotein for 6 weeks. 50-89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25-49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25-49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions."|Up to 354 days|Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2738002|NCT00963820|Secondary|TEmax: Time of Occurrence of Emax||Days 1 and 15 of Cycle 1|PD analysis population included all participants who had sufficient dosing data to calculate PD parameters|||Hours||Standard Deviation|Mean
2738003|NCT00963820|Secondary|Emax: Maximum Inhibition|A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m^2 cohort, so PD tables do not include that arm.|Days 1 and 15 of Cycle 1|PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters|||Percentage of inhibition||Standard Deviation|Mean
2738004|NCT00963820|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN2238|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal phase elimination half-life.|||hour||Standard Deviation|Mean
2738005|NCT00963820|Secondary|Terminal Elimination Rate Constant (λz) for MLN2238|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body and the values were used for calculation of T1/2. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal elimination rate constant.|||1/hour||Standard Deviation|Mean
2738006|NCT00963820|Secondary|Accumulation Ratio: Day 15 AUC0-168 / Day 1 AUC0-168 for MLN2238|MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of accumulation ratio.|||unitless||Standard Deviation|Mean
2738007|NCT00963820|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for MLN2238|AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC[0-tau]), where tau is the length of the dosing interval - 168 hours in this study). MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of AUC(0-168).|||hr*ng/mL||Standard Deviation|Mean
2738008|NCT00963820|Secondary|Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238|Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.|||hours||Full Range|Median
2738009|NCT00963820|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN2238|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.|||ng/mL||Standard Deviation|Mean
2738010|NCT00963820|Primary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events|"An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.~A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)|Safety Population included all randomized participants who received study drug.|||participants|||Number
2738011|NCT00963807|Secondary|Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST version 1.1 was utilized for this outcome measure. A detailed description of RECIST 1.1 can be found here: Nishino M, Jackman DM, Hatabu H, Yeap BY, Cioffredi LA, Yap JT, et al. New Response Evaluation Criteria in Solid Tumors (RECIST) guidelines for advanced non-small cell lung cancer: comparison with original RECIST and impact on assessment of tumor response to targeted therapy. AJR Am J Roentgenol 2010;195:W221-8.|Up to 6 weeks||||percentage of participants|||Number
2738012|NCT00963807|Secondary|Change in 18F-Fluorodeoxyglucose (FDG) Uptake|Will be calculated by subtracting the baseline FDG uptake from the post-cycle 2 uptake (as measured by SULmax).|Baseline and 6 weeks||||SULmax||Standard Deviation|Mean
2738013|NCT00963807|Primary|Change in FLT Uptake in Responders and Non-responders|Unadjusted analysis will be performed utilizing students t-tests. If the data appears non-normal, the Wilcox on rank-sum test will be used rather than the t-test. Adjusted analysis will be performed utilizing logistic regression.|Baseline and 6 weeks||||SULmax||Standard Deviation|Mean
2738014|NCT00963807|Primary|Change in FLT Uptake|Will be calculated by subtracting the uptake of the scan after the second cycle of chemotherapy from the uptake of the pre-treatment scan.|Baseline and 6 weeks||||SULmax||Standard Deviation|Mean
2738015|NCT00963807|Primary|Change in 18F-Fluorothymidine (FLT) Uptake|Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.. Change in FLT uptake will be measured using the maximum standard uptake value adjusted for lean body mass (SULmax), which is a measure of how much radiotracer (in this case FLT) is being consumed by cells.|Baseline and 3 weeks||||SULmax||Standard Deviation|Mean
2738016|NCT00963677|Secondary|Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet|The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.|1 hour (peri-intubation time)||||seconds||Standard Deviation|Mean
2738017|NCT00963677|Primary|Number of the Patients With Successful Nasotracheal Intubation|After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.|1 hour(peri-intubation time)||||participants|||Number
2738018|NCT00963638|Primary|Frequency/Duration of Muscle Cramps||30 days|||||||
2738019|NCT00963638|Primary|Change in Frequency of Leg Cramps|Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).|30 days||||Cramps per week||Standard Deviation|Mean
2738020|NCT00963599|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738021|NCT00963599|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738022|NCT00963599|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2739194|NCT00956839|Primary|Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml|Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml|6 months post intervention|Intention to treat analysis|||percentage of patients||95% Confidence Interval|Number
2738023|NCT00963599|Secondary|Mean Change From Baseline in Nasal Congestion Upon Awakening|Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738024|NCT00963599|Secondary|Mean Change From Baseline in Daytime Sneezing Score|Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738025|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Itching Score|Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738026|NCT00963599|Secondary|Mean Change From Baseline in Daytime Rhinorrhea Score|Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738027|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Congestion Score|Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738028|NCT00963599|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738029|NCT00963599|Secondary|Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)|Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738030|NCT00963599|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738031|NCT00963599|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738032|NCT00963560|Primary|Best Corrected Visual Acuity|"Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm."|6 Months after surgery|2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.|||logMAR||Standard Deviation|Mean
2738033|NCT00963547|Primary|Recommended Phase 2 Dose of MK-2206 in Combination With Trastuzumab (Part 1) and With Trastuzumab/Lapatinib (Part 2)|The recommended phase 2 dose (RP2D) of MK-2206 in combination with trastuzumab (Part 1) was assessed. Data from Part 1 informing the determination of the MTD (i.e. DLTs in cycle 1), along with safety and tolerability data, and the pharmacokinetic profile was used to determine the RP2D for both the QOD and QW dosing of MK-2206 in combination with trastuzumab. As the study was terminated prior to Part 2 enrollment, the RP2D of MK-2206 in combination with trastuzumab/lapatinib could not be determined.|Up to 36 weeks (up to 4 weeks following cessation of study treatment)|All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated), categorized by QOD or QW dosing of MK-2206. Due to trial termination, participants were not enrolled in Part 2; RP2D could not be calculated for Part 2.|||mg|||Number
2738043|NCT00963469|Secondary|Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2739136|NCT00957359|Primary|State-Trait Anxiety Inventory (STAI) State|"STAI scores 20-80 (higher score more anxiety). Commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80)."|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2738034|NCT00963547|Primary|Maximum Tolerated Dose of MK-2206 in Combination With Trastuzumab (Part 1) and With Trastuzumab/Lapatinib (Part 2)|The maximum tolerated dose (MTD) of MK-2206 in combination with trastuzumab (Part 1) was assessed for both QOD and QW dosing schedules. To calculate MTD, a dose-response curve for the rate of patients in each treatment combination arm experiencing a DLT in Cycle 1 will be estimated using the pooling-of-adjacent-violators algorithm, with this dose-response curve used to determine the MTD. The MTD is defined as the dose at which the percentage of patients experiencing a DLT is the closest to 25% or 30% in Part 1 and Part 2, respectively. As the study was terminated prior to Part 2 enrollment, the MTD of MK-2206 in combination with trastuzumab/lapatinib could not be determined.|Up to 3 weeks (up to day 21 of cycle 1)|All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated), categorized by QOD or QW dosing of MK-2206. Due to trial termination, participants were not enrolled in Part 2; MTD could not be calculated for Part 2.|||mg|||Number
2738035|NCT00963547|Primary|Number of Participants Experiencing ≥1 Dose-Limiting Toxicity (DLT) in Cycle 1|A DLT is a drug-related AE not related to disease progression or intercurrent illnesses. Toxicities are graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 3.0. The following are considered DLTs: A.) Hematologic [grade 4 neutropenia (≥5 days); grade 3/4 neutropenia; grade 4 thrombocytopenia.] B.) Non-Hematologic [any grade ≥3 non-hematologic toxicity except: grade 3 nausea, vomiting, diarrhea, or dehydration; asthenia; hypersensitivity; grade 3 elevated transaminases (1 week).] C.) Additional [any drug-related AE leading to MK-2206 dose modification; grade ≥2 drug-related AE causing drug interruption (≥8 days); any drug-related AE causing drug interruption (≥15 days); grade ≥3 glucose intolerance with grade ≥2 hyperglycemia; fasting glucose >250 mg/dL (≥2 days); grade ≥3 electrolyte abnormality; lactoacidosis or ketoacidosis; non-fasting grade 4 hyperglycemia; increased QTc interval; significant bradycardia.].|Up to 3 weeks (up to day 21 of cycle 1)|All participants in Part 1 receiving ≥1 dose of study drug were included: 1) if experiencing a DLT in cycle 1; or 2) if not experiencing a DLT in cycle 1, received 90% of planned doses and completed all safety evaluations by ≤20 days after first dose of MK-2206. Trial terminated before Part 2 enrollment; Part 2-specific arms excluded.|||Participants|||Count of Participants
2738036|NCT00963547|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event|The number of participants discontinuing study drug due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Further, any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.|Up to 32 weeks|All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; Part 2-specific arms are not included for analysis.|||Participants|||Count of Participants
2738037|NCT00963547|Primary|Number of Participants Experiencing ≥1 Adverse Event|The number of participants experiencing an adverse event (AE) was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Further, any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.|Up to 36 weeks (up to 4 weeks following cessation of study treatment)|All participants in Part 1 receiving ≥1 dose of study medication (i.e. all participants as treated). Due to trial termination, participants were not enrolled in Part 2; Part 2-specific arms are not included for analysis.|||Participants|||Count of Participants
2738038|NCT00963508|Secondary|Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).|"The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.~Treatment Success in the Efficacy ITT (LOCF)"|3 weeks|Proportion of subjects that are lice free 14 days after their first treatment|||percentage of subjects|||Number
2738039|NCT00963508|Primary|Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)|"The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)~Treatment Success in the Efficacy ITT (LOCF)~index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))"|3 weeks|Efficacy: index subjects who had at least one application of treatment mITT: treated subjects who had at least one post-treatment visit Subjects with missing efficacy data were included first LOCF and then with non-LOCF PP: subjects who complied with the protocol, completed all required visits Safety: all subjects who had at least one treatment|||percentage of subjects|||Number
2738040|NCT00963482|Secondary|Drinking in the Last 7 Days (Patients Report + Urine Sample)||6 months|||||||
2738041|NCT00963482|Primary|Number of Smoke-free Patients|"Smoke-free defined with following measures:~patients self-report about smoking in the last 7 days (yes/no)~CO-level (smoke-free <10ppm)~urine sample (cotinine)"|6 months|Intention-to-treat analysis|||participants|||Number
2738042|NCT00963469|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2738157|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738044|NCT00963469|Secondary|Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2738045|NCT00963469|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2738046|NCT00963469|Secondary|Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period|Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2738047|NCT00963469|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2738048|NCT00963469|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Nasal Symptoms Score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2738049|NCT00963430|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the ITT safety cohort.|||Participants|||Number
2738050|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
2738051|NCT00963430|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, each counted separately.|||Participants|||Number
2738052|NCT00963430|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.|||Participants|||Number
2738062|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738053|NCT00963430|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
2738054|NCT00963430|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
2738055|NCT00963430|Primary|Number of Participants Reporting Fever After Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738056|NCT00963430|Primary|Number of Participants Reporting Fever After First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738057|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738058|NCT00963430|Secondary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
2738059|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if a cord blood sample was collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 5 due to specimen processing errors at the time of sample collection.|||Participants|||Number
2738060|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if they had blood collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 3 due to specimen processing errors at the time of sample collection. Participants were analyzed as treated.|||Participants|||Number
2738061|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738960|NCT00957801|Primary|High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)|High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
2738063|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738064|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738065|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738066|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2738067|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2738068|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever greater than or equal to [>=]38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours [hrs]); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs). Report of fever >40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2738069|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2738086|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2738070|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2738071|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.5 to 10.0 cm); Severe (greater than [>] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2738072|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||fold rise||95% Confidence Interval|Geometric Mean
2738073|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||fold rise||95% Confidence Interval|Geometric Mean
2738074|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2738075|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2738076|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||mcg/mL||95% Confidence Interval|Geometric Mean
2738087|NCT00963157|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
2756618|NCT00831129|Secondary|Change in Urinary Isoprostane|change in urinary isoprostane between baseline and 6 month|Baseline and 6 months||||ng/ml||Standard Deviation|Mean
2738077|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2738078|NCT00963235|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||fold rise||95% Confidence Interval|Geometric Mean
2738079|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738080|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738081|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738082|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to eligibility deviation. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738083|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2738084|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2738085|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2738088|NCT00963157|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
2738089|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738090|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738091|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738092|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738093|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738094|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738120|NCT00963105|Secondary|Time to Response|Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.|Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.|Randomized participants with an objective response (CR/CRi or PR)|||weeks||Full Range|Median
2738095|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738096|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2738097|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2738098|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.|||Participants|||Number
2738099|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738100|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738101|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738102|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738153|NCT00962741|Other Pre-specified|Number of Participants With Neutralizing Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2738103|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738104|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738105|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738106|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.|||Participants|||Number
2738107|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collection at the timepoint are included. Analyses are as treated.|||Participants|||Number
2738108|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.|||Participants|||Number
2738109|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738110|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738111|NCT00963157|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 365 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2738112|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738113|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to influenza-like illness. This outcome restricts to age stratum.|||Participants|||Number
2738114|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2738115|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to an eligibility deviation. This outcome restricts to age stratum.|||Participants|||Number
2738116|NCT00963105|Secondary|Kaplan-Meier Estimate of Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.|From randomization until the end of the study; maximum time on study was 91 months.|All randomized participants|||weeks||95% Confidence Interval|Median
2738117|NCT00963105|Secondary|Kaplan-Meier Estimate of Progression Free Survival|Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.|From randomization until the end of the study; maximum time on study was 91 months.|All randomized participants|||weeks||95% Confidence Interval|Median
2738118|NCT00963105|Secondary|Kaplan-Meier Estimate of Event-Free Survival|Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.|From randomization until the end of the study; maximum time on study was 91 months.|All randomized participants|||weeks||95% Confidence Interval|Median
2738119|NCT00963105|Secondary|Kaplan-Meier Estimate of Time to Progression|Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.|From randomization until the end of the study; maximum time on study was 91 months.|All randomized participants|||weeks||95% Confidence Interval|Median
2738154|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: PsA Sub-population||Baseline up to Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a firstdegree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738121|NCT00963105|Secondary|Kaplan-Meier Estimate of Duration of Response|Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.|Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.|Randomized participants with an objective response (CR/CRi or PR)|||weeks||95% Confidence Interval|Median
2738122|NCT00963105|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL.|Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.|All randomized participants (intent-to-treat population)|||percentage of participants|||Number
2738123|NCT00963105|Primary|Number of Participants With Treatment-emergent Adverse Events|Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.|From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.|Randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2738124|NCT00962949|Secondary|Cortisol Level||1 hour||||ng/ml/h||Standard Error|Mean
2738125|NCT00962949|Secondary|Aldosterone Level||1 hour||||picogram/milliliter||Standard Error|Mean
2738126|NCT00962949|Secondary|Plasma Renin Activity||1 hour||||micrograms/deciliter||Standard Error|Mean
2738127|NCT00962949|Primary|Mean Arterial Blood Pressure Change||1 hour||||mm/Hg||Standard Error|Mean
2738128|NCT00962871|Secondary|Early Changes in Viral Sequence Associated With Viral Suppression|Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.|Day 1, 5, 14, Week 4 and 6|||||||
2738129|NCT00962871|Secondary|Mean Change From Baseline in HBV-DNA log10|An acute virologic response was determined by change from baseline in HBV-DNA log10.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.|||IU/mL||Standard Deviation|Mean
2738130|NCT00962871|Primary|Mean Change From Baseline in Viral Quantitative e Antibody|An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.|||Cut-off index (C.O.I.)||Standard Deviation|Mean
2738131|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2738155|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: ERA Sub-population||Baseline up to Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738961|NCT00957801|Primary|High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)|High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
2738132|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2738133|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2738134|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2738135|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2738136|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2738137|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2738962|NCT00957801|Primary|Triglycerides Measured on Treatment Day 8 (Post Study)|Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
2738138|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||titers||95% Confidence Interval|Geometric Mean
2738139|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2738140|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||mcg/mL||95% Confidence Interval|Geometric Mean
2738141|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2738142|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||titers||95% Confidence Interval|Geometric Mean
2738143|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2738156|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population||Baseline up to Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2756619|NCT00831129|Primary|Change in High-sensitivity C-reactive Protein|change in high-sensitivity C-reactive between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
2738144|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||mcg/mL||95% Confidence Interval|Geometric Mean
2738145|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2738146|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2738147|NCT00962780|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."|||titers||95% Confidence Interval|Geometric Mean
2738148|NCT00962780|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies all participants who were evaluable for this measure and n signifies all participants who were evaluable for specified serotype for each treatment arm, respectively."|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2738149|NCT00962780|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.|||fold rise||95% Confidence Interval|Geometric Mean
2738150|NCT00962754|Secondary|Complications|notifications of complications|duration of admission||||participants|||Number
2738151|NCT00962754|Secondary|Use of Diuretics|prescription of diuretic therapy|during days of admission||||participants|||Number
2738152|NCT00962754|Primary|Duration of Admission at the Ward in Days|Duration of hospital stay in days or duration of admission at the pediatric ward in days|1-8 months|intention to treat analysis|||number of days||Full Range|Median
2738158|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738159|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738160|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738161|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738162|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for PsA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738163|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for ERA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738164|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for eoJIA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738165|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738166|NCT00962741|Other Pre-specified|Height z-Score by Age Group for PsA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738167|NCT00962741|Other Pre-specified|Height z-Score by Age Group for ERA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738168|NCT00962741|Other Pre-specified|Height z-Score by Age Group for eoJIA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA sub-population: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738169|NCT00962741|Other Pre-specified|Height z-Score by Age Group|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
2738170|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for PsA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738171|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for ERA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738172|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for eoJIA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738173|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738174|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): PsA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738175|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): ERA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|ERA:participants with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen-B27;Ar in male>6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738176|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): eoJIA Subpopulation|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738177|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
2738178|NCT00962741|Other Pre-specified|Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population|"PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and Almost clear' includes all participants who were scored as a 0 or 1."|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738179|NCT00962741|Other Pre-specified|Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of BSA||Standard Deviation|Mean
2738180|NCT00962741|Other Pre-specified|Modified Schober's Test for ERA Sub-population|Modified Schober's Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||cm||Standard Deviation|Mean
2738181|NCT00962741|Other Pre-specified|Nocturnal Back Pain Score for ERA Sub-population|Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mm||Standard Deviation|Mean
2738182|NCT00962741|Other Pre-specified|Overall Back Pain Score for ERA Sub-population|Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mm||Standard Deviation|Mean
2738183|NCT00962741|Other Pre-specified|Tender Entheseal Assessment for ERA Sub-population|Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Tender entheses||Standard Deviation|Mean
2758417|NCT00816777|Secondary|Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0)|0 - No data collected|6 weeks|Data not collected study terminated early||||||
2738184|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738185|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar /enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738186|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738187|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738188|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
2738189|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;humanleukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
2738190|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
2738191|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
2738202|NCT00962741|Secondary|C-reactive Protein (CRP): eoJIA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/L||Standard Deviation|Mean
2758418|NCT00816777|Primary|Progression Free Survival||1 year|||||||
2738192|NCT00962741|Secondary|Duration of Morning Stiffness: PsA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
2738193|NCT00962741|Secondary|Duration of Morning Stiffness: ERA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
2738194|NCT00962741|Secondary|Duration of Morning Stiffness: eoJIA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
2738195|NCT00962741|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
2738196|NCT00962741|Secondary|Pain Assessment: PsA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738197|NCT00962741|Secondary|Pain Assessment: ERA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738198|NCT00962741|Secondary|Pain Assessment: eoJIA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738199|NCT00962741|Secondary|Pain Assessment|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738200|NCT00962741|Secondary|C-reactive Protein (CRP): PsA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/L||Standard Deviation|Mean
2738201|NCT00962741|Secondary|C-reactive Protein (CRP): ERA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/L||Standard Deviation|Mean
2758419|NCT00816751|Secondary|Gestational Age at Time of Procedure||At the time of the procedure||||Days||Standard Deviation|Mean
2738203|NCT00962741|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/Liter (mg/L)||Standard Deviation|Mean
2738204|NCT00962741|Secondary|Number of Joints With Limitation of Motion: PsA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738205|NCT00962741|Secondary|Number of Joints With Limitation of Motion: ERA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738206|NCT00962741|Secondary|Number of Joints With Limitation of Motion: eoJIA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738207|NCT00962741|Secondary|Number of Joints With Limitation of Motion|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738208|NCT00962741|Secondary|Number of Active Joints: PsA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738209|NCT00962741|Secondary|Number of Active Joints: ERA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738210|NCT00962741|Secondary|Number of Active Joints: eoJIA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2760008|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|up to 44 weeks||||inches||Standard Deviation|Mean
2738211|NCT00962741|Secondary|Number of Active Joints|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
2738212|NCT00962741|Secondary|Patient/Parent Global Assessment: PsA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738213|NCT00962741|Secondary|Patient/Parent Global Assessment: ERA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738214|NCT00962741|Secondary|Patient/Parent Global Assessment: eoJIA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738215|NCT00962741|Secondary|Patient/Parent Global Assessment|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738216|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738217|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738218|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738219|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
2738220|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738248|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|"Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').~Scores for Symptoms 5, 10, and 11 on the MRS were summed and analyzed. Total summed scores ranged from 0 to 12, with higher scores representing more severe symptoms."|4 weeks from Baseline (Day 0)||||units on a scale||95% Confidence Interval|Mean
2738221|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738222|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738223|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738224|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738225|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738226|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738227|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738228|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738319|NCT00961896|Primary|Number of Participants With at Least Partial Clinical Clearance (Part I)|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|day 8, day 15, day 22, day 29|All part I participants were included in the analysis.|||Number of participants|||Number
2738229|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738230|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738231|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738232|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738233|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738234|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738235|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738236|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738337|NCT00961805|Primary|Visual Analog Scale for Pain|score between 0 and 100 where 0 is no pain and 100 in unbearable pain|baseline, after 16 weeks and after 32 weeks||||mm||Standard Deviation|Mean
2738338|NCT00961662|Secondary|Body Weight Loss (Compared to Baseline)||6 months|||||||
2738339|NCT00961662|Secondary|A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study||6 months|||||||
2738340|NCT00961662|Secondary|A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study||8 months|||||||
2738237|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with arthritis(Ar) or(/)enthesitis,any 2:sacroiliac joint tenderness/inflammatory(Ifm)lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;acute anterior uveitis(AAU)/AAU first-degree relative.|||Percentage of participants||95% Confidence Interval|Number
2738238|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738239|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
2738240|NCT00962741|Primary|Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12|ACR Pedi 30 response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 12|Modified Intent-to-Treat (mITT) population included all participants who received at least 1 dose of the study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure at week 12.|||Percentage of participants||95% Confidence Interval|Number
2738241|NCT00962650|Primary|Completion of Diagnostic Peritineoscopy|"Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox~Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome."|Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar|The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.|||Participants|||Number
2738242|NCT00962598|Primary|ACC GABA/Water|The ratio of gamma-Aminobutyric acid (GABA) and water in the brain (ratio divided by 10000 for analysis purposes), that was observed in MR Spectroscopy. GABA, an amino acid produced by cells of the central nervous system, is an inhibitory neurotransmitter, prominent in the human brain.|baseline and 10-weeks||||ratio * 10^-4||Standard Deviation|Mean
2738243|NCT00962598|Primary|ACC Glx/Water|The data reflects the ratio of Glutamine-Glutamate and water in the brain (ratio divided by 10000 for analysis purposes). Glutamate is a precursor to Glutamine, an amino acid which functions as an excitatory neurotransmitter in the human brain.|baseline and 10-weeks||||ratio * 10^-4||Standard Deviation|Mean
2738244|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined|"The following analysis pre-specified the combining of all S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) into a single treatment group. The results from the Wilcoxon-Mann-Whitney test (pair-wise test), based on the change from Baseline at Week 4, are presented.~Note: Dryness of Vagina was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)||||units on a scale||95% Confidence Interval|Mean
2738245|NCT00962585|Secondary|Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: MRS consists of 11 symptoms, where each symptom is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Percentage Change||95% Confidence Interval|Mean
2738246|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined|"The following analysis shows the results when the S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) are combined and regarded as a single treatment group.~Note: Each MRS symptoms was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)||||units on a scale||95% Confidence Interval|Mean
2738247|NCT00962585|Post-Hoc|Percentage Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)||||Percentage Change||95% Confidence Interval|Mean
2738341|NCT00961662|Secondary|A Decrease of ≥0.5% in HbA1c Level at Each Study Visit||6 months|||||||
2738249|NCT00962585|Secondary|Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4|"MRS consists of 11 menopause symptoms. The scoring scheme is simple, i.e., the score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items (severity 0 [no complaints] 4 scoring points [extremely severe symptoms]). The respondent provides her personal perception by checking one of 5 possible boxes of severity for each of the items. The composite score (total score) is the sum of the 11 item scores, which can range from 0 (no symptoms) to 44 (extremely severe symptoms). Low total scores represent less severe menopause symptoms while higher scores represent more severe symptoms."|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||units on a scale||95% Confidence Interval|Mean
2738250|NCT00962585|Secondary|Change From Baseline in Progesterone Concentration at Week 2 and Week 4|No repeated measures ANCOVA results are presented for change from Baseline in progesterone concentrations since the model did not converge.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Progesterone Concentration (nmol/L)||95% Confidence Interval|Mean
2738251|NCT00962585|Secondary|Change From Baseline in Estradiol Concentration at Weeks 2 and 4|The LSMeans refer to overall adjusted mean estradiol concentration.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Estradiol Concentration (pmol/L)||95% Confidence Interval|Mean
2738252|NCT00962585|Secondary|Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4|"The Vaginal Maturation Index was calculated by examining the maturation of the vaginal epithelium as adjudged by the cell types exfoliated. Parabasal cells are the least mature cells, intermediate cells display mild maturation, and superficial cells display the most maturity. The cell count is expressed as a percentage. The Vaginal Maturation Index was calculated as: 0.2*(parabasal cells, %)+0.6*(intermediate cells, %)+1.0*(superficial cells, %). This method is described in Menopause 2005;12(6):708-15.~The index serves as an objective means of evaluating hormonal secretion or response; lower values indicate more immature cells on the surface (atrophy), while higher values indicate more mature epithelium.~The LSMeans refer to overall adjusted mean percent of cells counted."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||percentage of cells||95% Confidence Interval|Mean
2738253|NCT00962585|Secondary|Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4|"The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. The pH scale is logarithmic and as a result, each whole pH value below 7 is ten times more acidic than the next higher value.~Normal vaginal pH is 3.8 to 4.5, slightly acidic.~The LSMeans refer to overall adjusted mean pH."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||units on a scale||95% Confidence Interval|Mean
2738254|NCT00962585|Secondary|Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4|"The severity of vasomotor symptoms per week at each of the protocol visits was calculated for each patient as follows: [(Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date - Previous protocol visit date (days)] * 7, where severity of vasomotor symptoms were scored as: 1 = mild, 2 = moderate and 3 = severe. Higher values represented worse severity.~LSMeans refer to the overall adjusted mean severity of VMS.~Hot Flush Classification: Mild: sensation of heat without sweating; Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity.~Patients recorded the number of hot flushes (day and night) in their diaries related to the severity (mild/moderate/severe)."|1, 2, and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||units on a scale||95% Confidence Interval|Mean
2738255|NCT00962585|Secondary|Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2|"The frequency of MSVS per week, at each of the protocol visits, was calculated as follows, for each patient: [# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)] * 7.~The ANCOVA procedure tested the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp, where μ1 and μp denote the mean frequency of MSVS, adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively.~LSMeans refer to the overall adjusted mean frequecy of MSVS."|1 and 2 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Number of MSVS/week||95% Confidence Interval|Mean
2738256|NCT00962585|Secondary|Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period)|"Change from Baseline in the frequency of MSVS (difference between Baseline [period following first 7 days of 2-week run-in period] and period following first 7 days of 2-week Week 4 period), where the Baseline MSVS frequency was captured at visit 3 (Day 0), in the period following the first 7 days, as per CRF. Note: this endpoint is identical to the primary endpoint, however, instead of a 14 ± 2 day period, the period following the first 7 days was used, at Baseline and visit 3.~Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (period following first 7 days of 2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Number of MSVS/week||95% Confidence Interval|Mean
2738342|NCT00961662|Secondary|Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit||6 months|||||||
2738257|NCT00962585|Primary|Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period)|"The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline [2-week run-in period] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as sensation of heat with sweating, able to continue activity; severe is defined as sensation of heat with sweating, causing cessation of activity. Patients used the take-home daily diary to record MSVS information during the run-in period and treatment period and analyses were performed as specified.~Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Number of MSVS/2 weeks||95% Confidence Interval|Mean
2738258|NCT00962390|Secondary|Change in DAN Prostate Symptom Scale From Baseline at Week 4|The questionnaire is made up of two kinds of questions: intensity of a symptom and bothersomeness of a symptom. Prostate symptoms are addressed in questions 1 - 12 and sexual function in questions 13 - 15. Patients indicate how intense/frequent (scoring 0, 1, 2, or 3; where 0 represents the best case and 3 the worst case) and how bothersome the symptom (scoring 0, 1, 2, or 3; where 0 is 'not at all' and 3 is 'very much'). DAN-PSS total and DAN-PSS total sexual function score were calculated by multiplying the frequency score by the trouble score of each symptom, and then adding the resulting figures. The possible values of DAN-PSS total ranged from 0 to 108 and of DAN-PSS total sexual function score ranged from 0 to 27. A reduction in DAN-PSS total and/or sexual function score is consistent with improved BPH symptoms/sexual functioning.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||units on a scale||Standard Deviation|Mean
2738259|NCT00962390|Secondary|Change in I-PSS Total Score From Baseline at Week 4|The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); and Severe (symptom score range 20-35). A reduction in I-PSS Total Score is consistent with improvement in symptoms of BPH.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||units on a scale||Standard Deviation|Mean
2738260|NCT00962390|Secondary|Investigators Assessment of Nocturia at Week 4|Investigators were asked to rate participant's change in nocturia since the Baseline Visit.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||number of times urinated at night||Full Range|Median
2738261|NCT00962390|Secondary|Participants Assessment of Nocturia at Week 4|Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||number of times to urinate at night||Full Range|Median
2738262|NCT00962390|Secondary|Change in Total Testosterone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||nmol/L||Standard Deviation|Mean
2738263|NCT00962390|Secondary|Change in Luteinizing Hormone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||IU/L||Standard Deviation|Mean
2738264|NCT00962390|Secondary|Change in in Dihydrotestosterone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||pg/mL||Standard Deviation|Mean
2738265|NCT00962390|Secondary|Change in Post-Void Residual Volume From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL||Standard Deviation|Mean
2738266|NCT00962390|Secondary|Change in Void Volume From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL||Standard Deviation|Mean
2738267|NCT00962390|Secondary|Percent Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||Participants|||Count of Participants
2738268|NCT00962390|Secondary|Categorical Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||Participants|||Count of Participants
2738269|NCT00962390|Secondary|Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL/sec||Standard Deviation|Mean
2738270|NCT00962390|Secondary|Change in Prostate Volume From Baseline at Week 4|Prostate size as measured by prostate volume as assessed by transrectal ultrasound.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL||Standard Deviation|Mean
2738343|NCT00961662|Primary|Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus|The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).|6 months from baseline|ITT Population|||participants|||Number
2738271|NCT00962390|Primary|Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.|Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study.|4 weeks|All Participants who received at least 1 dose of study drug and who had a post-dose PSA assessment at Week 4.|||ng/mL||Standard Error|Least Squares Mean
2738272|NCT00962247|Secondary|Energy Intake|Resting metabolic rate was calculated using the activity data from accelerometer (Actigraph) collection. Resting metabolic rate was used to calculate estimated daily energy expenditure. Daily energy expenditure and weight change over the study period was used to estimate energy intake. If weight was stable of the nine weeks, assume energy intake = energy expenditure. A gain of a pound was estimated as equivalent to a positive balance of 3500 calories and a loss of a pound was estimated as equivalent to a negative balance of 3500 calories.|3 days||||calories/day||Standard Error|Mean
2738273|NCT00962247|Primary|Physical Activity|Actigraph activity monitors were used to record physical activity over 3 days, in addition to a weekly physical activity diary. Acti-graph counts were used to estimate energy expenditure during waking hours. Counts per minute describes the average rate of counts, with 0 being at rest and higher numbers indicating more vigorous physical activity.|3 days||||counts/minute of physical activity||Standard Error|Mean
2738274|NCT00962208|Secondary|Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear||2 years|||||||
2738275|NCT00962208|Secondary|Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups||2 years|||||||
2738276|NCT00962208|Primary|Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study|Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.|2 years||||mm||Standard Deviation|Mean
2738277|NCT00962104|Secondary|Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks|The HAMD-17 was used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). Higher scores indicate greater symptom severity. The total score is the sum of the scores from HAMD-17 Items 1 through 17. The total score may range from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMD-17 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738278|NCT00962104|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks|Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMA-14 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738279|NCT00962104|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks|The CGI-ADHD-I is a single-item clinician rating of the clinician's assessment of the participant's improvement in ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened).|Up to 10 weeks|All randomized participants with an endpoint CGI-ADHD-I value within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738280|NCT00962104|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks|The CGI-ADHD-S is a single-item clinician rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants).|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CGI-ADHD-S result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738281|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738396|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738282|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738283|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-S:SV result were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2738284|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2738285|NCT00962104|Secondary|Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline EQ-5D result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738286|NCT00962104|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks|Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline AAQoL result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738287|NCT00962104|Primary|Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks|CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2738288|NCT00962091|Secondary|Best Overall Response (CR+PR) Based on Investigator's Assessment According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Best overall response is defined as the number of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 for target lesions and assessed by CT or MRI. CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum LD since the treatment started.|At the completion of Cycle 2 and every 2 cycles (every 6 weeks) until Cycle 6 (18 weeks). After Cycle 6 (18 weeks), CT/MRI scans (with contrast) were to be performed every 3 cycles (9 weeks) until PD was documented.|Efficacy analysis included all participants who had a baseline response assessment and at least one on-study response assessment.|||participants|||Number
2738289|NCT00962091|Primary|Number of Participants With Abnormal Vital Signs Reported as Adverse Events|Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study.|Up to 30 days after the last dose of study drug (up to 24 months approximately)|Safety Population is defined as all participants who receive any amount of alisertib.|||participants|||Number
2738397|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|Baseline|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738290|NCT00962091|Primary|Number of Participants With Abnormal Laboratory Values Reported as Adverse Events at an Incidence of at Least 5%|Laboratory AEs reported at an incidence of at least 5% overall in the following system organ classes (SOCs) are reported: blood and lymphatic system disorders, metabolism and nutrition disorders, investigations, and hepatobiliary disorders. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment--emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 30 days after the last dose of study drug (up to 27.4 months)|Safety Population is defined as all participants who receive any amount of alisertib.|||participants|||Number
2738291|NCT00962091|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Up to 30 days after the last dose of study drug (up to 27.4 months)|Safety population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2738292|NCT00962091|Primary|Part C: AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for Alisertib Administered as an Enteric-Coated Capsule (ECT) With Food Versus Without Food||Cycles 1 and 2 on Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|The PK evaluable population including all participants with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis.|||nM*h||Standard Error|Mean
2738293|NCT00962091|Primary|Part C: AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration for Alisertib Administered as an Enteric-Coated Capsule (ECT) With Food Versus Without Food||Cycles 1 and 2 on Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|The PK evaluable population including all participants with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis.|||nM*h||Standard Deviation|Mean
2738294|NCT00962091|Primary|Part C: Cmax: Maximum Observed Concentration for Alisertib Administered as an Enteric-Coated Capsule (ECT) With Food Versus Without Food|Participants were randomized to receive 50-mg alisertib as an ECT (single, 50-mg strength tablets) under fasted or fed (following a standardized high-fat meal) conditions.|Cycles 1 and 2 Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|PK-evaluable population including all participants with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis.|||nM||Standard Deviation|Mean
2738295|NCT00962091|Primary|Part B: AUCτ: Area Under the Concentration-Time Curve From Time 0 to End of Dosing Interval for Alisertib Oral Solution Following Multiple-Dose Administration|Not performed.|Cycle 1 Day 9 predose and at multiple time points (up to 12 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|Data from Part B were not analyzed as planned because this part of the study was terminated after only 6 of the planned 14 PK-evaluable participants were enrolled, as the OS was not stable and gelled prior to dosing. With PK evaluability being compromised by gelling of the OS, the data were not analyzed as planned.||||||
2738296|NCT00962091|Primary|Part B: Tmax: Time of First Occurrence of Cmax Over the Dosing Interval for Alisertib Oral Solution Following Multiple-Dose Administration|Not performed.|Cycle 1 Day 9 predose and at multiple time points (up to 12 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|Data from Part B were not analyzed as planned because this part of the study was terminated after only 6 of the planned 14 PK-evaluable participants were enrolled, as the OS was not stable and gelled prior to dosing. With PK evaluability being compromised by gelling of the OS, the data were not analyzed as planned.||||||
2738297|NCT00962091|Primary|Part B: Cmax: Maximum Plasma Concentration for Alisertib Oral Solution Following Multiple-Dose Administration|Not performed.|Cycle 1 Day 9 predose and at multiple time points (up to 12 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|Data from Part B were not analyzed as planned because this part of the study was terminated after only 6 of the planned 14 PK-evaluable participants were enrolled, as the OS was not stable and gelled prior to dosing. With PK evaluability being compromised by gelling of the OS, the data were not analyzed as planned.||||||
2738298|NCT00962091|Primary|Part B: AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration for Alisertib Administered as an Oral Solution With Food Versus Without Food|Not performed.|Cycles 1 and 2 Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|Data from Part B were not analyzed as planned because this part of the study was terminated after only 6 of the planned 14 PK-evaluable participants were enrolled, as the OS was not stable and gelled prior to dosing. With PK evaluability being compromised by gelling of the OS, the data were not analyzed as planned.||||||
2738299|NCT00962091|Primary|Part B: Cmax: Maximum Observed Concentration for Alisertib Administered as an Oral Solution With Food Versus Without Food|Not performed.|Cycles 1 and 2 Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|Data from Part B were not analyzed as planned because this part of the study was terminated after only 6 of the planned 14 PK-evaluable participants were enrolled, as the OS was not stable and gelled prior to dosing. With PK evaluability being compromised by gelling of the OS, the data were not analyzed as planned.||||||
2760009|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|baseline||||inches||Standard Deviation|Mean
2738300|NCT00962091|Primary|Part A: Dose-normalized AUClast (Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration) for Estimation of Relative Bioavailability for Alisertib Oral Solution (OS) Versus Powder in Capsule Formulations (PIC)|Dose normalized AUClast was obtained using Cmax divided by alisertib dose in milligrams to provide values adjusted to a 1 mg alisertib dose.|Cycles 1 and 2 Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual AE that was judged by the investigator to be treatment related.|PK evaluable population including all participants with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis. Data for Cycle 1 and Cycle 2 were combined for analyses.|||nM*hr/mg||Standard Deviation|Mean
2738301|NCT00962091|Primary|Part A: Dose-normalized Cmax (Maximum Observed Concentration) for Estimation of Relative Bioavailability for Alisertib Oral Solution (OS) Versus Powder in Capsule Formulations (PIC)|Dose normalized Cmax was obtained using Cmax divided by alisertib dose in milligrams to provide values adjusted to a 1 mg alisertib dose.|Cycles 1 and 2 Day 1 predose and at multiple time points (up to 48 hours) postdose, and, if clinically feasible, at the time of a serious or unusual adverse event (AE) that was judged by the investigator to be treatment related.|Pharmacokinetic (PK)-evaluable population including all participants with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis. Data for Cycle 1 and Cycle 2 were combined for analyses.|||nM/mg||Standard Deviation|Mean
2738302|NCT00962078|Secondary|Dyspnoea During Exercise Measured on the Borg Scale|"The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea.~The scale is like follows:~0 Nothing at all~Very slight~Slight~Moderate~Somewhat severe~Severe~7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal"|mean values from day 1 to day 21||||units on a scale||Standard Deviation|Mean
2738303|NCT00962078|Primary|Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)||value at day 21 minus value at day 1||||meter||Standard Deviation|Mean
2738304|NCT00962065|Secondary|Change From Baseline at Day 28 in Triglycerides||Baseline to Day 28||||mg/dL||95% Confidence Interval|Mean
2738305|NCT00962065|Secondary|Change From Baseline at Day 28 in Mean Arterial Pressure||Baseline to Day 28||||mm Hg||95% Confidence Interval|Mean
2738306|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma Fructosamine Level||Baseline to Day 28||||µmol/L||95% Confidence Interval|Mean
2738307|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma HbA1c||Baseline to Day 28||||Percent||95% Confidence Interval|Mean
2738308|NCT00962065|Secondary|Change From Baseline at Day 29 in Fasting Plasma Glucose||Baseline to Day 29||||mg/dL||95% Confidence Interval|Mean
2738309|NCT00962065|Primary|Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion|To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.|Baseline to Day 28||||grams||95% Confidence Interval|Mean
2738310|NCT00962013|Secondary|Post-surgery Femoral Crack/Fracture and Subsidence Rate||Post-op to 5 years|Post-surgery femoral crack/fracture and subsidence rate were assessed by hip.|||percentage of hips|hips||Number
2738311|NCT00962013|Primary|Femoral Stem Fracture||5 years|Participants who received the Restoration Modular Hip System.|||femoral stem fractures|||Number
2738312|NCT00962013|Secondary|SF-36 Health Status Survey: Role - Physical|"Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state:~The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health~This Secondary Outcome Measure is focused on the Role-Physical score."|pre-op, 2 year and 5 year|SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36)|||units on a scale|hips|Standard Deviation|Mean
2738313|NCT00962013|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|pre-op and 5 years||||units on a scale|hips|Standard Deviation|Mean
2738314|NCT00962013|Secondary|Radiographic Stability|Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.|5 years|41 hips had fully evaluable radiographs at the 5 year interval; 40 out of the 41 hips are stable.|||percentage of stable hips|hips|95% Confidence Interval|Number
2738315|NCT00962013|Primary|Stem Survivorship (%)|Failure is defined by stem revision for any cause.|5 years|Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.|||stem survivorship percentage at 5 years|hips|90% Confidence Interval|Number
2738316|NCT00962000|Secondary|Kt/V Determined From Measurements of Ionic Dialysance|Kt/VID was determined for all study treatments at 2 of the 3 centers using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor).|4 weeks||||Kt/VID|Treatments|Standard Deviation|Mean
2738317|NCT00962000|Secondary|Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. The formula for equilibrated Kt/Vurea takes urea rebound into consideration. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).|4 weeks||||equilibrated Kt/Vurea (eKt/V)|Treatments|Standard Deviation|Mean
2738318|NCT00962000|Primary|Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|"The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the single-pool Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA)."|4 weeks||||single-pool Kt/Vurea (spKt/V)|Treatments|Standard Deviation|Mean
2738430|NCT00960986|Secondary|Time to Onset of Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Baseline to onset of nausea (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||days||95% Confidence Interval|Median
2738320|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part II)|"Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the 3D LIFEVIZ Micro system, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement."|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.|||Percent change in tumor measurement|Participants|Standard Deviation|Mean
2738321|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part I)|"Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the 3D LIFEVIZ Micro system, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement."|4 weeks|All part I participants were included in this analysis.|||Percent change in tumor measurement|Participants|Standard Deviation|Mean
2738322|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part II)|"Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated.. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the 3D LIFEVIZ Micro system, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement."|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.|||percent change in tumor measurement||Standard Deviation|Mean
2738323|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part I)|"Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the 3D LIFEVIZ Micro system, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement."|4 weeks|All part I participants were included in the analysis.|||Percent change in tumor measurement||Standard Deviation|Mean
2738324|NCT00961896|Primary|Percentage of BCCs With Complete and at Least Partial Clinical Clearance|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|4 weeks, 6 weeks, 9 weeks|All participants were analyzed.|||Percentage of BCCs|Participants||Number
2738325|NCT00961805|Secondary|Self-image - Body Dysmorphic Disorder Examination Questionnaire|scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image|Baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738326|NCT00961805|Secondary|Depression - Beck Inventory|score between 0 from 63, with higher score indicating greater depression|Baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738327|NCT00961805|Secondary|Quality of Life - SF-36 - Mental Health|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738328|NCT00961805|Secondary|Quality of Life - SF-36 - Emotional Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738329|NCT00961805|Secondary|Quality of Life - SF-36 - Social Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738330|NCT00961805|Secondary|Quality of Life - SF-36 - Vitality|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738331|NCT00961805|Secondary|Quality of Life - Sf-36 - General Health State|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738332|NCT00961805|Secondary|Quality of Life - Sf-36 - Pain|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738333|NCT00961805|Secondary|Quality of Life - SF-36 - Physical Limitation|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738334|NCT00961805|Secondary|Quality of Life - SF-36 -Functional Capacity|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738335|NCT00961805|Secondary|Quality of Life - Fibromyalgia Impact Questionnaire|score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
2738336|NCT00961805|Secondary|Function - 6 Minute Walk Test|meters traveled on a 20-meter course over a six-minute period|baseline, after 16 weeks and after 32 weeks||||meters||Standard Deviation|Mean
2738344|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.|Baseline, Week 6|PP: All subjects who received study drug, satisfied inclusion/exclusion criteria, and had at least 1 scheduled on-therapy visit. Individual subject visits or data points were excluded if protocol criteria were violated at a subset of the subject's visits and the violations, in the opinion of the Medical Monitor, did not invalidate remaining visits.|||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
2738345|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).|Baseline, Week 6|ITT: All subjects who received study drug and had at least 1 scheduled on-therapy study visit.|||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
2738346|NCT00961636|Secondary|Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).|||Participants|||Number
2738347|NCT00961636|Primary|Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).|||Participants|||Number
2738348|NCT00961571|Primary|Progression-free Survival|Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.|36 months|Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.|||months||Full Range|Median
2738349|NCT00961532|Secondary|Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)|We prospectively defined acute adverse events as: new fever >=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP < 100 mm Hg or new vasopressor use or increase in vasopressor dose by >25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.|within 6 hours of study treatment||||participants|||Number
2738350|NCT00961532|Primary|Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment|The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.|60 minutes after treatment start||||seconds||Standard Error|Mean
2738351|NCT00961441|Secondary|Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.|From Starting Study Drug Treatment (Day 1) to up to 14 days|Safety Set includes all subjects who took at least one dose of study medication. The Safety Set is identical to the Intention-to-treat (ITT) population in this study.|||Count|||Number
2738352|NCT00961441|Primary|Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration|The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population|||L/h||Geometric Coefficient of Variation|Geometric Mean
2738353|NCT00961441|Primary|Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration|The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population|||hours (h)||Full Range|Median
2738354|NCT00961441|Primary|Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration|"AUCtau normalized by 1000 mg dose was calculated as:~AUCtau/(mg dose taken/ 1000 mg Keppra XR).~AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).~6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population|||µg*h/mL||95% Confidence Interval|Geometric Mean
2738355|NCT00961441|Primary|Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration|"The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.~Cmax normalized by 1000 mg dose was calculated as:~Cmax/(mg dose taken/ 1000 mg Keppra XR).~Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).~Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population|||µg/mL||95% Confidence Interval|Geometric Mean
2738356|NCT00961415|Secondary|Quality of Life|European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles.|Up to 21 months|The ITT population included all the participants that were randomized.|||Score on scale||Standard Deviation|Mean
2738357|NCT00961415|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ).|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.|||Participants|||Number
2738358|NCT00961415|Secondary|Incidence of Adverse Events and Serious Adverse Event|An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.|||Participants|||Number
2738359|NCT00961415|Secondary|Duration of Disease Control During Maintenance Treatment Phase|Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.|||Months||95% Confidence Interval|Median
2738360|NCT00961415|Secondary|Duration of Response During Maintenance Treatment Phase|Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.Participants available at particular time point for assessment were included in the analysis.|||Months||95% Confidence Interval|Median
2738361|NCT00961415|Secondary|Best Overall Response Rate During Maintenance Treatment Phase|The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population which included all the participants that were randomized.|||percentage of participants||95% Confidence Interval|Number
2738362|NCT00961415|Secondary|Overall Survival During Maintenance Treatment Phase|Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.|||Months||95% Confidence Interval|Median
2739137|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2738363|NCT00961415|Primary|Progression Free Survival During Maintenance Treatment Phase|Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.|||Months||95% Confidence Interval|Median
2738364|NCT00961402|Secondary|PHQ-9|Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression|6 Months||||Score on a scale||Standard Deviation|Mean
2738365|NCT00961402|Secondary|Edinburgh Postnatal Depression Scale|This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.|6 Months||||Score on a scale||Standard Deviation|Mean
2738366|NCT00961402|Secondary|7-Day Physical Activity Recall Interview|Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).|6 months||||Number of physical activity minutes||Standard Deviation|Mean
2738367|NCT00961402|Primary|Structured Clinical Interview for DSM-IV Axis I Disorders|This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.|6 months||||percentage of participants|||Number
2738368|NCT00961350|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 Months|Intent to Treat (ITT) Population|||participants|||Number
2738369|NCT00961350|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738370|NCT00961350|Secondary|"The Number of Subjects With Treatment Success"|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 Months|Intent to Treat Population|||participants|||Number
2738371|NCT00961350|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 Months|Intent to Treat (ITT) Population|||participants|||Number
2738372|NCT00961350|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738373|NCT00961311|Secondary|Device Success|Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow.|1-3 days||||Percent of Participants|||Number
2738374|NCT00961311|Secondary|Vessel Perforation (Clinical)|Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.|1-3 days||||Percent of Participants|||Number
2738375|NCT00961311|Secondary|Major Adverse Cardic Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.|1-3 days||||Percent of Participants|||Number
2738376|NCT00961311|Primary|Procedural Success|Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.|1-3 days||||Percent of Participants|||Number
2738377|NCT00961298|Secondary|Irritable Bowel Syndrome Severity Scoring System|This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.|endpoint [12 weeks]||||scores on a scale||Standard Deviation|Mean
2738378|NCT00961298|Secondary|Irritable Bowel Syndrome-Quality of Life Scale|"The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 not at all to 5 extremely or a great deal Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170."|endpoint [12 weeks]||||scores on a scale||Standard Deviation|Mean
2738379|NCT00961298|Secondary|Hamilton Anxiety Rating Scale|"The HAM-A is a 14 question scale with five responses. Responses range from 0 not present to 4 very severe. The total score ranges from 0 to 56. Higher values represent a worse outcome."|endpoint [12 weeks]||||scores on a scale||Standard Deviation|Mean
2738380|NCT00961298|Primary|Clinical Global Impression Scale|"The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.~The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 very much improved, 4 no change, and 7 very much worse."|endpoint [12 weeks]|per protocol|||scores on a scale||Standard Deviation|Mean
2738963|NCT00957801|Primary|Triglycerides Measured on Treatment Day 1 (Baseline Study)|Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
2738381|NCT00961259|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.|||ng-hr/mL||Standard Deviation|Mean
2738382|NCT00961259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the [AUC(0-t)] values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.|||ng-hr/mL||Standard Deviation|Mean
2738383|NCT00961259|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.|||ng/mL||Standard Deviation|Mean
2738384|NCT00961233|Primary|Tissue Eosinophil Counts|Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment|8 weeks||||# of eosinophils per high-power field||Standard Deviation|Mean
2738385|NCT00961233|Secondary|Adrenal Insufficiency|Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.|8 weeks||||participants|||Number
2738386|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After seventh course at 14 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738387|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After first course at 2 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738388|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738389|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738390|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738391|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738392|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738393|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738394|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|1 week after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2738395|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
2760010|NCT00807560|Secondary|Percent Completion|Percent of participants who completed the trial to assess feasibility and retention in the trial|at 44 weeks||||percentage of participants|||Number
2738398|NCT00961220|Primary|Overall Response Rate|"Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness.~CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score compared to baseline. PD: Increase of greater or equal to 25% of the SWAT score compared to baseline while the patient is actively taking the study drug"|Up to 2 weeks after completion of study treatment|Intention to treat|||participants|||Number
2738399|NCT00961181|Secondary|Device Success|"Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)||||participants|||Number
2738400|NCT00961181|Secondary|Technical Success|"Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)||||participants|||Number
2738401|NCT00961181|Secondary|Binary In-segment Restenosis|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||participants|||Number
2738402|NCT00961181|Secondary|Binary In-stent Restenosis|"In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||participants|||Number
2738403|NCT00961181|Secondary|In-segment Diameter Stenosis (%DS)|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||percentage of re-narrowing||Standard Deviation|Mean
2738404|NCT00961181|Secondary|In-stent Diameter Stenosis (%DS)|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||percentage of re-narrowing||Standard Deviation|Mean
2738405|NCT00961181|Secondary|Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)|All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.|12 months|2 patients died, 2 patients withdrew consent, 1 patient lost to follow up|||participants|||Number
2738406|NCT00961181|Secondary|Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)|"All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.~Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR"|6 months|2 patients died, 2 patients withdrew consent|||participants|||Number
2738407|NCT00961181|Secondary|In-segment Late Lumen Loss|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||mm||Standard Deviation|Mean
2738408|NCT00961181|Primary|In-stent Late Lumen Loss|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||mm||Standard Deviation|Mean
2738409|NCT00961116|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
2738410|NCT00961116|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
2738411|NCT00961116|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.|||ng/mL||Standard Deviation|Mean
2738412|NCT00961064|Primary|Response Rate at 16-20 Weeks|The primary endpoint was hematologic response at 16 or 20 weeks, defined as either: (1) an increase in platelet counts =20.000/uL or transfusion independence for a minimum of 8 weeks; (2) hemoglobin (Hb) increase of =1.5g/dL from baseline, or a reduction in red blood cells (RBC) transfusion of at least 50%; or (3) an increase in absolute neutrophil counts (ANC) of =0.5x109/L or by at least 100% in patients with a baseline ANC <0.5x109/L.|16-20 weeks||||Participants|||Count of Participants
2738413|NCT00961051|Secondary|Number of Subjects With no Corneal Staining|Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.|Day 180||||participants|||Number
2738414|NCT00961051|Primary|Mean Lens Cleanliness as Measured by Light Reflectance|Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).|Day 30|Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).|||light reflectance score||Standard Deviation|Mean
2738415|NCT00960999|Secondary|Association Between Biomarkers and Grade 2+ Radiation Pneumonitis||From start of treatment to 1 year|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2738416|NCT00960999|Secondary|Association Between Biomarkers and Primary Tumor Control Rate||From start of treatment to 1 year|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2738417|NCT00960999|Secondary|Change in Percentage of Expected Carbon Monoxide Diffusing Capacity (DLCO) by Best Observed Tumor Response at 6 Months Post-radiotherapy|Carbon monoxide diffusing capacity (DLCO), a measure of pulmonary function, was reported as percentage of the value that would be expected for the normal general population of the same height, age, and sex. Change from baseline is calculated by subtracting the follow-up value from the baseline value. A positive change from baseline indicates decreased DLCO. Best observed tumor response was evaluated using the Revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 (http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf).|From start of treatment to 6 months post-radiotherapy|Eligible patients with DLCO at baseline and 6 months, and with best tumor response of complete response, partial response, or stable disease|||percentage of predicted value||Standard Deviation|Mean
2738418|NCT00960999|Secondary|Change in Percentage of Expected Forced Expiratory Volume in 1 Second (FEV1) by Best Observed Tumor Response at 6 Months Post-radiotherapy [Forced Expiratory Volume in 1 Second (FEV1)]|Forced expiratory volume (FEV1), a measure of pulmonary function, was reported as percentage of the value that would be expected for the normal general population of the same height, age, and sex. Change from baseline is calculated by subtracting the follow-up value from the baseline value. A positive change from baseline indicates decreased FEV1. Best observed tumor response was evaluated using the Revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 (http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf).|From start of treatment to 6 months post-radiotherapy|Eligible patients with FEV1 at baseline and 6 months, and with best tumor response of complete response, partial response, or stable disease|||percentage of predicted value||Standard Deviation|Mean
2738419|NCT00960999|Secondary|Change in Normalized Standardized Uptake Value (SUV) at One Year|Standardized uptake value (SUV) describes the level of biologic activity in a particular spot compared to activity elsewhere in the body. An SUV reading of 1 is considered normal cellular activity, with higher values indicating increased activity. SUV was measured from whole-body FDG-PET scans that were required at baseline and requested (not required) at 12 weeks and 12 months post-radiotherapy. Normalized SUV = peak SUV of regions of interest / mean SUV of the aortic arch. Change from baseline is calculated by subtracting the follow-up value from the baseline value. A positive change from baseline indicates decreased SUV. SUV does not have a unit.|Baseline and one year|eligible patients with normalized SUV at baseline and one year|||SUV||Full Range|Median
2738721|NCT00958789|Secondary|Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits|The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.|pre-op, 1, 2, 5 years|||||||
2738420|NCT00960999|Secondary|Change in Normalized Standardized Uptake Value (SUV) at 12 Weeks|Standardized uptake value (SUV) describes the level of biologic activity in a particular spot compared to activity elsewhere in the body. An SUV reading of 1 is considered normal cellular activity, with higher values indicating increased activity. SUV was measured from whole-body FDG-PET scans that were required at baseline and requested (not required) at 12 weeks and 12 months post-radiotherapy. Normalized SUV = peak SUV of regions of interest / mean SUV of the aortic arch. Change from baseline is calculated by subtracting the follow-up value from the baseline value. A positive change from baseline indicates decreased SUV. SUV does not have a unit.|Baseline and 12 weeks|eligible patients with normalized SUV at baseline and 12 weeks|||SUV||Full Range|Median
2738421|NCT00960999|Secondary|Change in Peak Standardized Uptake Value (SUV) at One Year Post-radiotherapy|Standardized uptake value (SUV) describes the level of biologic activity in a particular spot compared to activity elsewhere in the body. An SUV reading of 1 is considered normal cellular activity, with higher values indicating increased activity. Peak SUV is an average SUV computed within a fixed-size volume of interest (VOI), most often containing (and not necessarily centered on) the hottest pixel value. Peak SUV was measured from whole-body FDG-PET scans that were required at baseline and requested (not required) at 12 weeks and 12 months post-radiotherapy. Change from baseline is calculated by subtracting the follow-up value from the baseline value. A positive change from baseline indicates decreased SUV. SUV does not have a unit.|Baseline and one year|eligible patients with PET SUV data at at baseline and one year|||SUV||Full Range|Median
2738422|NCT00960999|Secondary|Change in Peak Standardized Uptake Value (SUV) at 12 Weeks Post-radiotherapy|Standardized uptake value (SUV) describes the level of biologic activity in a particular spot compared to activity elsewhere in the body. An SUV reading of 1 is considered normal cellular activity, with higher values indicating increased activity. Peak SUV is an average SUV computed within a fixed-size volume of interest (VOI), most often containing (and not necessarily centered on) the hottest pixel value. Peak SUV was measured from whole-body FDG-PET (fluorodeoxyglucose - positron emission tomography) scans that were required at baseline and requested (not required) at 12 weeks and 12 months post-radiotherapy. Change from baseline is calculated by subtracting the follow-up value from the baseline value. A positive change from baseline indicates decreased SUV.|Baseline and 12 weeks post-radiotherapy|eligible patients with PET SUV data at at baseline and 12 weeks|||SUV||Full Range|Median
2738423|NCT00960999|Secondary|1-year Disease-free Survival Rate|Disease-free survival is defined as being alive without experiencing in-field, marginal, involved lobe, regional or metastatic failure, development of a second primary, or death due to any cause. Disease-free survival time is defined as time from randomization to the the date of first failure or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.|From start of treatment to 1 year|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2738424|NCT00960999|Secondary|1-year Overall Survival Rate|Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.|From start of treatment to 1 year|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2738425|NCT00960999|Secondary|1-year Primary Tumor Control Rate|Primary tumor control is defined as the lack of primary tumor failure. Primary tumor failure is defined as the development of in-field or marginal failure. Primary tumor control time is defined as time from randomization to the the date of primary tumor failure, last known follow-up (censored), or death without failure (competing risk). Primary tumor control rates are estimated using the cumulative incidence method.|From start of treatment to 1 year|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2738426|NCT00960999|Primary|Counts of ≥ Grade 3 Adverse Events (AE) Graded by CTCAE v4 (Common Terminology Criteria for Adverse Events) That Are Definitely, Probably, or Possibly Related to Treatment (DPPRT)|Number of patients with ≥ grade 3 AE occurring within 1 year of treatment (TRT) start and reported as DPPRT among this subset of CTCAE v4: pericardial effusion, pericarditis, restrictive cardiomyopathy, dysphagia, esophagitis, esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage, rib fracture, brachial plexopathy, recurrent laryngeal nerve palsy, myelitis, atelectasis, bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, bronchial/pulmonary/bronchopleural/tracheal fistula, hypoxia, bronchial/tracheal obstruction, pleural effusion, pneumonitis, pulmonary fibrosis, skin ulceration (thorax only), FEV1 (Forced Expiratory Volume) or FVC (forced vital capacity) decline, or grade 5 related to TRT. Each arm is considered independently. For each arm, >=5 of 38 analyzable subjects experiencing a grade ≥ 3 AE during the 1st year following TRT start would determine the respective TRT excessively toxic. For each arm this design provides 88% power with a 0.10 type I error rate.|From start of treatment to 1 year|First 38 eligible patients per arm who started treatment|||participants|||Number
2738427|NCT00960986|Secondary|Percentage of Patients Achieving Remission|Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||percentage of participants|||Number
2738428|NCT00960986|Secondary|Percentage of Participants Achieving Response|Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||percentage of participants|||Number
2738429|NCT00960986|Secondary|Time to Resolve Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Nausea onset up to nausea resolve (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||days||95% Confidence Interval|Median
2738964|NCT00957801|Primary|Total Cholesterol Measured on Treatment Day 8 (Post Study)|Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
2738431|NCT00960986|Secondary|Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks|The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix.|1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738432|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)|The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738433|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale|The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738434|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale|The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738435|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale|The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738436|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale|The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738437|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|"The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix."|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738438|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score|The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
2738439|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score|AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity.|Baseline, 1 week, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||units on a scale||Standard Error|Least Squares Mean
2738440|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score|Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||units on a scale||Standard Error|Least Squares Mean
2738441|NCT00960986|Secondary|Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. N = number of subjects with a baseline and post-baseline result at the Week 8 visit.|||units on a scale||Standard Error|Least Squares Mean
2738442|NCT00960986|Primary|Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.|1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||units on a scale||95% Confidence Interval|Mean
2738443|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
2738444|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)|Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.|Baseline to Month 6|The 'Per Protocol' population was used for this analysis. The Per-Protocol population was defined as a subset population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
2738445|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
2738446|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.|Baseline to Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
2738447|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)|The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
2738448|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine|Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738449|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip|Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738450|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD|"DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738451|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD|"DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738452|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD|"DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738453|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD|"DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738454|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD|"DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738455|NCT00960934|Primary|Percentage of Participants With Bone Neoplasms|"Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
2738456|NCT00960934|Primary|Percentage of Participants With Kidney Stones|"Evidence of kidney stone(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
2738457|NCT00960934|Primary|Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
2738458|NCT00960934|Primary|Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
2738459|NCT00960934|Primary|Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)|"Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline (BL) and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2738460|NCT00960869|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738461|NCT00960869|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738462|NCT00960869|Secondary|"The Number of Subjects With Treatment Success"|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738463|NCT00960869|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738464|NCT00960869|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||participants|||Number
2738465|NCT00960856|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
2738965|NCT00957801|Primary|Total Cholesterol Measured on Treatment Day 1 (Baseline Study)|Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
2738466|NCT00960856|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
2738467|NCT00960856|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.|||ng/mL||Standard Deviation|Mean
2738468|NCT00960843|Secondary|Rate of Weight Loss kg/wk at Day 180|Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).|Screening to Day 180|Per Protocol population|||kg/week||Standard Deviation|Mean
2738469|NCT00960843|Secondary|Mean Static Intraband Pressure at Day 180|Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)|Day 180|Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis.|||mmHg||Standard Deviation|Mean
2738470|NCT00960843|Primary|Percent Excess Weight Change at Day 180|Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.|Screening to Day 180|Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.|||percentage of excess weight at screening||Standard Deviation|Mean
2738471|NCT00960778|Primary|Post- Cue Exposure Craving Denicotinized Cigarettes|Participants will complete cue exposure sessions after 4 days of denicotinized cigarette us and rate craving on a 10 item self-report questionnaire, the Questionnaire of Smoking Urges- Brief (QSU-B). Participants rate craving on a scale on a 1-7 point Likert scale where indicates Strongly Disagree and 7 indicates Strongly Agree. Higher scores indicate higher craving. Ratings from the 10 items are summed to attain the score reported here.|Day 7|8 women and 13 men complete the 4 days of denicotinized cigarette use and completed the third scan.|||score on a scale||Standard Deviation|Mean
2738472|NCT00960778|Primary|Post- Cue Exposure Craving Nicotine Patch|Participants will complete cue exposure sessions after 3 days of nicotine patch use and rate craving on a 10 item self-report questionnaire. The Within Sessions Rating scale measures craving with 0 indicating Not at All and 10 indicating Extremely.|Day 3|12 women and 15 men completed the 3 days of Nictoine Replacement Therapy and completed the second scan.|||score on a scale||Standard Deviation|Mean
2738473|NCT00960687|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
2738474|NCT00960687|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
2738475|NCT00960687|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.|||ng/mL||Standard Deviation|Mean
2738476|NCT00960661|Secondary|Minor Hypoglycemia Rate Per Year|Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL)|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.|||rate per year||Standard Deviation|Mean
2738477|NCT00960661|Secondary|Major Hypoglycemia Rate Per Year|Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.|||rate per year||Standard Deviation|Mean
2738478|NCT00960661|Secondary|Daily Insulin Glargine Dose at Baseline and at Week 30|Daily Insulin Glargine Dose at baseline and at Week 30|Baseline, week 30|Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively).|||IU/day||Standard Deviation|Mean
2738479|NCT00960661|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30|Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).|||mmHg||Standard Error|Least Squares Mean
2738480|NCT00960661|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 30|Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).|||mmHg||Standard Error|Least Squares Mean
2738481|NCT00960661|Secondary|Change in Body Weight From Baseline to Week 30.|Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, week 30|Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively).|||kg||Standard Error|Least Squares Mean
2738482|NCT00960661|Secondary|Change in Low Density Lipoprotein (LDL) From Baseline to Week 30|Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, Week 30|Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively).|||mmol/L||Standard Error|Least Squares Mean
2738483|NCT00960661|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to Week 30|Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).|||mmol/L||Standard Error|Least Squares Mean
2738484|NCT00960661|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).|||mmol/L||Standard Error|Least Squares Mean
2738485|NCT00960661|Secondary|Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.|Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively).|||mmol/L||Standard Error|Least Squares Mean
2738486|NCT00960661|Secondary|Percent of Participants Achieving HbA1c ≤ 6.5%.|Percent of participants achieving HbA1c ≤ 6.5%.|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).|||percentage of participants|||Number
2738487|NCT00960661|Secondary|Percentage of Participants Achieving HbA1C < 7.0%|Percentage of participants achieving HbA1C < 7.0%|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).|||Percentage of participants|||Number
2738488|NCT00960661|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).|Baseline, 30 weeks|Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively.|||percent of hemoglobin||Standard Error|Least Squares Mean
2738489|NCT00960622|Primary|Change in Peak Oxygen Uptake.|change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.|baseline and 6 months||||ml/Kg/min||Standard Deviation|Mean
2738490|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.|||ng-hr/mL||Standard Deviation|Mean
2738658|NCT00959751|Post-Hoc|Sustained Complete Headache Relief (Efficacy Evaluable Analysis Set)|Exploratory Post-hoc Analysis: Sustained complete headache relief is defined as a reduction in headache severity from moderate or severe to absent over all indicated time points.|2 - 48 hours|Efficacy Evaluable Analysis Set includes all subjects in the Full Analysis Set with an observed or imputed HSS (using rules predefined in the Statistical Analysis Plan [SAP]) at both the 2-hour time point and the 4-hour time point when using the modified LOCF approach|||Participants|||Number
2738491|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.|||ng-hr/mL||Standard Deviation|Mean
2738492|NCT00960570|Primary|Maximum Plasma Concentration (Cmax) of Efavirenz|The maximum or peak concentration that efavirenz reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration.|30 subjects were enrolled in this study. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study interventions but withdrew consent prior to the 8 hour post-dose activities on Day 31.|||ng/mL||Standard Deviation|Mean
2738493|NCT00960531|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/ml||95% Confidence Interval|Geometric Mean
2738494|NCT00960531|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|24 months|All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.|||percentage of participants|||Number
2738495|NCT00960531|Other Pre-specified|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)|IgG subtypes were not assessed|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgG subtypes were not assessed.||||||
2738496|NCT00960531|Other Pre-specified|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not statistically analyzed.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not assessed.||||||
2738497|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2738498|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2738499|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2738500|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||participants|||Number
2738673|NCT00959660|Secondary|Body Composition|Total Body Fat Mass and Total Non-bone Lean Mass via DEXA|20 weeks||||kg||95% Confidence Interval|Mean
2738501|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738502|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738503|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738504|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738505|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
2738506|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
2738507|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||days||Standard Deviation|Mean
2738508|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||days||Standard Deviation|Mean
2738509|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||number of events||Standard Deviation|Mean
2739138|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|6 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2738510|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||number of events||Standard Deviation|Mean
2738511|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738512|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738513|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738514|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738515|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-FS:13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738516|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue Scale (FS):13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738674|NCT00959660|Secondary|Quality of Life|Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.|20 weeks||||units on a scale||95% Confidence Interval|Mean
2738517|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2738518|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||participants|||Number
2738519|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738520|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738521|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738522|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738523|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Month 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738524|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738525|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738675|NCT00959660|Primary|Exercise Capacity|Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.|20 weeks||||ml/kg/min||95% Confidence Interval|Mean
2738526|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738527|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Month 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738528|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738529|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738530|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738531|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2738532|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738533|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2738534|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2739139|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|1 day prior to drug administration 2||||score on a scale||Standard Error|Mean
2738535|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738536|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738537|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5 and 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738538|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738539|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738540|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738541|NCT00960440|Primary|Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738542|NCT00960440|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
2738676|NCT00959647|Primary|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
2738543|NCT00960440|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2738544|NCT00960375|Primary|Abstinence From Tobacco|Self-reported abstinence from tobacco + breath CO < 10 ppm|7 days|All randomized to condition|||participants|||Number
2738545|NCT00960375|Primary|Number of Cigarettes Smoked Per Day|Number of cigarettes smoked per day for the last 7 days|day|All randomized|||number of cigarettes||Standard Deviation|Mean
2738546|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew prior to Period II check-in. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 4 subjects in the Colchicine with Atorvastatin group.|||pg*hr/mL||Standard Deviation|Mean
2738547|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.|||pg*hr/mL||Standard Deviation|Mean
2738548|NCT00960323|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.|||pg/mL||Standard Deviation|Mean
2738549|NCT00960297|Secondary|To Assess Clinical & Pathologic Response Rate, Complete Resection Rate, Toxicity, Progression-free Survival, & Overall Survival.||60 months|||||||
2738550|NCT00960297|Primary|To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.||36 months|Study ended early due to slow accrual.||||||
2738551|NCT00960206|Secondary|Hip Follow-Up Questionnaire|"A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below)."|6-10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.|||hips|Hips||Number
2738552|NCT00960206|Secondary|Radiographic Evaluation|Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.|3-5 and 10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.|||hips|Hips||Number
2738553|NCT00960206|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|3-5 and 10 Years|Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting.|||hips|Hips||Number
2738554|NCT00960206|Primary|Component Revision and Complications|The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.|10 years|Number of participants analyzed includes all subjects enrolled.|||hips|hips||Number
2738555|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 2 subjects in the Colchicine with Seville orange juice group.|||pg*hr/mL||Standard Deviation|Mean
2738677|NCT00959647|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
2738556|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.|||pg*hr/mL||Standard Deviation|Mean
2738557|NCT00960193|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.|||pg/mL||Standard Deviation|Mean
2738558|NCT00960154|Primary|Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen|Overall histological quality score will be a composite of the histological metrics|Intraoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2738559|NCT00960154|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2738560|NCT00960141|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738561|NCT00960141|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738562|NCT00960141|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2 (or upon discontinuation)|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738563|NCT00960141|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738564|NCT00960141|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738565|NCT00960141|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2738566|NCT00960115|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration.|Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
2738604|NCT00959985|Secondary|To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer|Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review|5 years|The number and percentage of participants in each group who had at least 2 known risk factors for lymphedema is documented in the outcome measure data table below|||Participants|||Count of Participants
2738678|NCT00959647|Secondary|Incidence of Adverse Events Leading to GDC-0449 Discontinuation||30 days following the last administration of study treatment|||||||
2738567|NCT00960115|Secondary|Progression Free Survival (PFS) Time - Investigator Read|PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
2738568|NCT00960115|Secondary|Time To Progression (TTP) - Investigator Read|TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration.|Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
2738569|NCT00960115|Primary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
2738570|NCT00960076|Secondary|Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)|Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)|Week 18 (LOCF)||||Percentage of Participants|||Number
2738571|NCT00960076|Secondary|Change in FPG From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18||||mg/dL||Standard Error|Mean
2738572|NCT00960076|Secondary|Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18||||mg/dL||Standard Error|Mean
2738573|NCT00960076|Primary|Change in HbA1c Level From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18||||Percent||Standard Error|Mean
2738574|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)|The IGFBP-3 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-3 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-3 were not produced.||||||
2738575|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2)|The IGFBP-2 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-2 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-2 were not produced.||||||
2738576|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-2 (IGF-II)|IGF-II is generally produced locally in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-II were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-II were not produced.||||||
2738679|NCT00959647|Secondary|Incidence and Severity of All Adverse Events and Serious Adverse Events||30 days following the last administration of study treatment|||||||
2738577|NCT00960063|Secondary|Area Under the Curve During a Dosing Interval τ (AUCτ) for Robatumumab|AUCτ was defined as the area under the plasma concentration-time curve during a dosage interval (τ). Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCτ were not produced.||||||
2738578|NCT00960063|Secondary|Area Under the Curve at the Time of Final Quantifiable Sample (AUCtf) for Robatumumab|AUCtf for robatumumab was defined as the area under the curve at the time of the final quantifiable sample of robatumumab. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCtf were not produced.||||||
2738579|NCT00960063|Secondary|Time to Maximum Observed Concentration (Tmax) of Robatumumab|Tmax was defined as time of Cmax of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Tmax were not produced.||||||
2738580|NCT00960063|Secondary|Number of Participants Who Developed Anti-robatumumab Antibodies|The incidence of anti-robatumumab antibodies was to be assessed. Only participants who had a negative pre-treatment sample and a post-treatment sample were considered to be evaluable. If a participant had a single sample considered positive in the anti-robatumumab antibody assay (with the exception of pre-treatment positive participants), then they would be counted as positive in the immunogenicity assessment.|Prior to 1st and 8th doses of robatumumab, ~30 days after last dose of study drug, and 4 months after last dose of study drug (Up to ~13.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy and had a negative pre-treatment sample and a post-treatment sample.|||Participants|||Number
2738581|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-I (IGF-I)|IGF-I is produced largely by the liver in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-I were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-I were not produced.||||||
2738582|NCT00960063|Secondary|Maximum Observed Concentration (Cmax) of Robatumumab|Cmax was defined as the maximum observed serum concentration of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab pharmacokinetics (PK) were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Cmax were not produced.||||||
2738605|NCT00959985|Primary|To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema|Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)|5 years|Median scores for the upper extremity function questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
2760577|NCT00803114|Primary|The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum||24 hours postpartum|Analysis by intention to treat.|||participants|||Number
2738583|NCT00960063|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were to be identified as target lesions. Data were to be collected at Screening, every 6 weeks and at 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last). The best overall response was to be the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): >20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions; or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, every 6 weeks and at ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.|||Participants|||Number
2738584|NCT00960063|Primary|Number of Participants With Dose Limiting Toxicities|Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 [any duration] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs.|Up to ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.|||Participants|||Number
2738585|NCT00960011|Secondary|Wound Size|Size of main wound|intra-operative record||||mm||Standard Deviation|Mean
2738586|NCT00960011|Secondary|Size of Mesh (Vertical)|Vertical size of mesh (in mm).|intra-operative record||||mm||Standard Deviation|Mean
2738587|NCT00960011|Secondary|Size of Mesh (Longitudinal)|Longitudinal size of mesh (in mm).|intra-operative record||||mm||Standard Deviation|Mean
2738588|NCT00960011|Secondary|Number of Participants Whose Response Was YES is Reported|Patient will be asked by assessor in out-patient clinic about satisfaction about the whole arrangement of operation. We did not intend to grade the satisfaction but simply ask whether they are satisfied. Will be either YES or NO answer.|1 week after operation||||participants|||Number
2738589|NCT00960011|Secondary|Days go Outdoor|Post-op number of days that patient can go outdoor|1 week after operation||||days||Standard Deviation|Mean
2738590|NCT00960011|Secondary|Post-operative Stay|Post-operative stay (number of hours)|1 week after operation||||hours||Standard Deviation|Mean
2738591|NCT00960011|Secondary|Wound Pain on Coughing at 1 Week After Operation|wound pain on coughingt at 1 week after operation (Visual Analogue Score). It was in the form of 0-10 where 0 is no pain and 10 is maximal pain they experienced in their life. The higher the value, the more painful it is.|1 week after operation||||score on a scale||Standard Deviation|Mean
2738592|NCT00960011|Secondary|Wound Pain at Rest at 1 Week After Operation|Visual Analogue Score for measurement of wound pain at rest 1 week after operation|1 week after operation||||score on a scale||Standard Deviation|Mean
2738593|NCT00960011|Secondary|Total Number of Analgesic Used|Total Number of Analgesic Used: Tablets|1 week after operation||||Tablets||Standard Deviation|Mean
2738594|NCT00960011|Secondary|Pain or Discomfort Affecting Daily Activities at 6 Years After Operation|pain or discomfort which affecting daily activities at 6 years after operation|6 years after operation||||participants|||Number
2738595|NCT00960011|Secondary|Patient With Chronic Discomfort at 6 Years After Operation|Patient with persistent chronic discomfort at 6 years after operation. It described as an unpleasant feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention. It is differentiate from pain sensation.|6 years after operation||||participants|||Number
2738596|NCT00960011|Secondary|Patient With Palpable Mesh at 6 Years After Operation|Patient with clinical palpable mesh at 6 years after operation|6 years after operation||||participants|||Number
2738597|NCT00960011|Secondary|Patient With Testicular Atrophy From Post-op to 6 Years After Operation|Patient with testicular atrophy from post-op to 6 years after operation, by clinical examination|6 years after operations||||participants|||Number
2738598|NCT00960011|Secondary|Chronic Pain at 6 Years|Patient with persistent chronic pain sensation at 6 years after operation. It described as painful sensation feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention.|6 years after operation||||participants|||Number
2738599|NCT00960011|Secondary|Overall Recurrence at 6 Years|Overall recurrence at 6 years, including all recurrence|6 years after operation||||participants|||Number
2738600|NCT00960011|Secondary|Seroma Formation at First Follow-up|Seroma formation at first follow-up, go by clinical|1 week after operation||||number of patient with seroma at 1 week|||Number
2738601|NCT00960011|Secondary|Mesh Placement Time, Total Operative Time|Time from mesh place to end of operation, and total time of operation|Intra-operative record||||Minutes||95% Confidence Interval|Mean
2738602|NCT00960011|Primary|Operating Time From Skin Incision to Wound Closure|It measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.|Intra-operative record||||minutes||Standard Deviation|Mean
2738603|NCT00959985|Secondary|To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer|We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of >5%-<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema|5 years|Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below|||Participants|||Count of Participants
2761503|NCT00795951|Secondary|Irritation|Number of subjects who presented with irritation at patch removal|Visit 2: 48 hours after patch application||||participants|||Number
2738606|NCT00959985|Primary|To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema|Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)|5 years|Median scores for the quality of life questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
2738607|NCT00959985|Primary|To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema|Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)|5 years|Median scores for the fear avoidance behavior section on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
2738608|NCT00959985|Primary|To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema|Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)|5 years|Median scores of the symptom-related questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
2738609|NCT00959985|Primary|To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment|Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.|5 years|This outcome measure was compared between Groups 2A and 2B. No data was collected for Group 1A and 1B as this outcome does not apply to these groups|||Participants|||Count of Participants
2738610|NCT00959985|Primary|To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment|Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.|5 years|This outcome measure was compared between Group 1A (control) and Group 1B (compression garment). No data was collected for this outcome in Groups 2A and 2B|||Participants|||Count of Participants
2738611|NCT00959946|Secondary|Plasma Decay Half-Life (t1/2) - Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was to be calculated as 0.693/λz.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738612|NCT00959946|Secondary|Terminal-Phase Disposition Rate Constant (λz) - Part 2|The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738613|NCT00959946|Secondary|Apparent Oral Clearance (CL/F) - Part 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738614|NCT00959946|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - Part 2|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738615|NCT00959946|Secondary|Apparent Volume of Distribution (Vz/F) - Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738616|NCT00959946|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738617|NCT00959946|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738618|NCT00959946|Secondary|Duration of Response (DR) - Part 2|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738619|NCT00959946|Secondary|Clinical Benefit Rate - Part 2|Percent of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. SD: neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738620|NCT00959946|Secondary|Progression Free Survival (PFS) - Part 2|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738621|NCT00959946|Secondary|Best Overall Response - Part 1|Best overall response based on investigator's disease status assessment. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. Progressive disease (PD): at least 20% increase in sum of LD of target lesions taking as a reference smallest sum of the recorded LDs since treatment start, or the appearance of 1 or more new lesions. Stable disease (SD): neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 1 Baseline, every 6 weeks up to 6 months|Per protocol (PP) population included participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine within a 21-day period, had a baseline and at least 1 post-baseline tumor assessment, and had no major protocol violations.|||Participants|||Number
2738622|NCT00959946|Primary|Percentage of Participants With Objective Response - Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions (LDs) of the target lesions taking as a reference the baseline sum LDs.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2738623|NCT00959946|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after last dose of study treatment|Safety population: included participants who received at least 1 dose of the study medication.|||Percentage of Participants|||Number
2738624|NCT00959946|Primary|Maximum Tolerated Dose (MTD) - Part 1|The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.|Part 1 Baseline up to Day 21|DLT evaluable population included all participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine in the first 21 days of treatment or had experienced a DLT within the first 21 days of treatment. N (number of participants analyzed) signifies participants who were evaluable for this measure.|||mg|||Number
2738625|NCT00959920|Secondary|Difference in Cost Between the Two Interventions|Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.|End of study.|No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis.||||||
2738626|NCT00959920|Primary|Time to Delivery (by Any Route)|Time to delivery defined as IV placement to delivery of infant.|1 day|Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.|||Hours||Inter-Quartile Range|Median
2738627|NCT00959907|Primary|Horizontal Action Halo Diameter at 112 Days|Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|112 days|Intention to treat analysis. 55 volunteers - One drop out from visit 2 (28 days) to visit 3 (112 days): 54 volunteers.|||centimeter||Standard Deviation|Mean
2738628|NCT00959907|Primary|ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)|ECMAP(Evoked Compound Muscle Action Potentials) was accessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days||||microvolts||Standard Deviation|Mean
2738629|NCT00959907|Primary|Horizontal Action Halo Diameter at 28 Days|Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|28 days|The analysis was intention to treat (ITT); One drop out, from baseline to visit 1(intervention) and 3 drop outs from visit 1 to visit 2 (28 days after botulinum toxin injections). Started 59 volunteers - 4 drop outs, there was 55 volunteers in the first analysis.|||centimeter||Standard Deviation|Mean
2738630|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.|||ng*hr/mL||Inter-Quartile Range|Median
2738631|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.|||ng/mL||Inter-Quartile Range|Median
2738632|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
2738633|NCT00959894|Secondary|Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine.|4 weeks|Of 79 participants who initiated study medications, 14 provided paired plasma and genital secretion samples. The goal was to enroll a total of 20 participants (10 men and 10 women) into the genital secretion sub-group, however no women enrolled into this subgroup. Data are presented for semen and plasma etravirine concentrations for 14 men.|||ratio of semen:plasma drug concentration||Inter-Quartile Range|Median
2738634|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
2738635|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||percentage of body fat||95% Confidence Interval|Median
2738636|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||percentage of body fat||95% Confidence Interval|Median
2738646|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 96 weeks|Of 79 participants who initiated study medications, 63 had a Week 48 CD4+ cell count measurement (6 discontinued study participation prior to Week 96 and 10 were lost to follow-up).|||cells/uL||95% Confidence Interval|Median
2738637|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||µU/ml*mmol/L||Inter-Quartile Range|Median
2738638|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||mg/dL||Inter-Quartile Range|Median
2738639|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||µU/ml*mmol/L||Inter-Quartile Range|Median
2738640|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||mg/dL||Inter-Quartile Range|Median
2738641|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||µU/ml*mmol/L||Inter-Quartile Range|Median
2738642|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||mg/dL||Inter-Quartile Range|Median
2738643|NCT00959894|Secondary|Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks|The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring).|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.|||proportion of participants||95% Confidence Interval|Number
2738644|NCT00959894|Secondary|Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy|"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.~The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)."|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.|||participants|||Number
2738645|NCT00959894|Secondary|Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results|Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY)|96 weeks|Of participants with confirmed virologic failure, 8 had HIV-1 RNA levels ≥ 500 copies/mL and 6 of these had viral genotype results available (1 had previously discontinued study medication at Week 2, and 1 was missing).|||participants|||Number
2738647|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 CD4+ cell count measurement (4 discontinued study participation prior to Week 48 visit, 3 were lost to follow-up, and 3 missed the Week 48 visit).|||cells/uL||95% Confidence Interval|Median
2738648|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI).|Baseline to 24 weeks|Of 79 participants who initiated study medications, 73 had a Week 24 CD4+ cell count measurement (4 discontinued study participation prior to Week 24,1 missed the Week 24 visit, and 1 did not have a Week 24 CD4+ cell count measurement).|||cells/uL||95% Confidence Interval|Median
2738649|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
2738650|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
2738651|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement (3 participants had discontinued the study, 1 was lost to follow-up, and 1 missed the Week 24 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
2738652|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
2738653|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
2738654|NCT00959894|Primary|The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24|The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry).|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement. The primary analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
2738655|NCT00959764|Secondary|Change in Plasma CTx-1 From Baseline|Percent change from baseline of plasma CTx-1 at end of study=48 weeks|48 weeks|Modified Intent-to-Treat Population|||Percentage change from baseline||Standard Deviation|Least Squares Mean
2738656|NCT00959764|Secondary|Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)|Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.|24 weeks|Modified Intent-to-Treat Population|||percentage change from baseline||Standard Deviation|Least Squares Mean
2738657|NCT00959764|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine|Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.|48 weeks|Patients who were randomized, received treatment, and had at least one post-baseline BMD value measured at least 154 days after randomization.|||Percentage increase from baseline||Standard Deviation|Least Squares Mean
2738659|NCT00959751|Secondary|Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)|Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent|24 hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.|||Participants|||Number
2738660|NCT00959751|Secondary|Time (Hours) to First Use of Rescue Medication (Full Analysis Set)|Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.|24 Hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.|||Participants who required rescue||95% Confidence Interval|Median
2738661|NCT00959751|Primary|Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 4 hours), who did not use rescue medication and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.|4 hours|30 and 42 placebo and NXN-188 subjects, respectivley, experienced headache relief at 2 hours. 41 and 55 placebo and NXN-188 subjects, respectively, experienced headache relief at 4 hours.|||Participants|||Number
2738662|NCT00959751|Secondary|Complete Headache Relief (Efficacy Evaluable Analysis Set)||72 hours||||Participants|||Number
2738663|NCT00959751|Secondary|Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours||||Participants|||Number
2738664|NCT00959751|Secondary|Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours||||Participants|||Number
2738665|NCT00959751|Primary|Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.|2 hours|Modified LOCF - Efficacy Evaluable Analysis Set|||Participants|||Number
2738666|NCT00959699|Secondary|Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound|Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||percentage of participants|||Number
2738667|NCT00959699|Secondary|Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)|This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Baseline and Week 4|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||participants|||Number
2738668|NCT00959699|Secondary|Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)|The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 60|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||percentage of participants|||Number
2738669|NCT00959699|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24|EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 12|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the “n” value in the table below represents the number of participants with EVR at that time point.|||percentage of participants|||Number
2738670|NCT00959699|Secondary|Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)|SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period.|||percentage of participants|||Number
2738671|NCT00959699|Primary|Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication|SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||percentage of participants|||Number
2738672|NCT00959660|Secondary|Thigh Muscle Composition|Thigh Skeletal Muscle and Subcutaneous Fat via MRI|20 weeks||||cm^2||95% Confidence Interval|Mean
2738680|NCT00959374|Secondary|Cosmesis|Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).|12 weeks|Subjects who did not return for the 12 week follow-up visit were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2738681|NCT00959374|Primary|Total Dermal Closure Time|In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.|At time of surgery|Includes only those subjects where a deep dermal layer was closed.|||Minutes||Standard Deviation|Mean
2738682|NCT00959192|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
2738683|NCT00959192|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Z-score||Standard Deviation|Mean
2738684|NCT00959192|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.|"The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.~A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction."|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
2738685|NCT00959192|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
2738686|NCT00959192|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
2738687|NCT00959192|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
2738688|NCT00959192|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
2738689|NCT00959192|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
2738690|NCT00959192|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
2738691|NCT00959166|Secondary|Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites|"Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios.~By quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue."|30 days|24/12 subjects in each study group had MR spectroscopy and could be included in this analysis|||ratio||Standard Deviation|Mean
2738692|NCT00959166|Primary|Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection|Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.|30 days|16 subjects in total had PET scans and were included in the PET outcome|||binding potential ratio||Standard Deviation|Mean
2738693|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population|||Days||Standard Deviation|Mean
2738694|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population|||Days||Standard Deviation|Mean
2738695|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population|||Days||Standard Deviation|Mean
2738696|NCT00959049|Secondary|Serious Adverse Events (SAEs)||6 months after last study vaccination|Safety Population|||Participants|||Number
2738697|NCT00959049|Secondary|New Onset of Chronic Illnesses (NOCIs)|New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|6 months after last study vaccination|Safety population|||Participants|||Number
2738698|NCT00959049|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Events|30 days after each vaccination|Safety population|||Participants|||Number
2738699|NCT00959049|Primary|Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination|Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|30 days after the last study vaccination|Per-Protocol Population|||Percentage of participants||95% Confidence Interval|Number
2738700|NCT00959049|Primary|Geometric Mean Titer 30 Days After the Last Study Vaccination||30 days after the last study vaccination|Per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2738701|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population|||Participants|||Number
2738702|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78|||Participants|||Number
2738703|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110|||Participants|||Number
2738704|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Saline Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Saline|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with saline intervention.|||pmol/L||Standard Deviation|Mean
2738705|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Naloxone|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with Naloxone intervention.|||pmol/L||Standard Deviation|Mean
2738706|NCT00958919|Secondary|Endurance Time|Length of time that subjects were able to continue Resistive Load Breathing|Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.|||minutes||Standard Deviation|Mean
2738707|NCT00958919|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.~Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.|||units on a scale||Standard Deviation|Mean
2738708|NCT00958919|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.|||units on a scale||Standard Deviation|Mean
2738709|NCT00958893|Primary|To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.||three 4 month cycles separated by off-drug intervals|||||||
2738710|NCT00958880|Secondary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change (SPDSC) Form is a version of the Clinical Global Improvement-Severity scale adapted specifically for clinician ratings of social anxiety disorder symptom severity. The scale ranges from 0 to 5, with higher scores indicating more social anxiety symptoms severity (i.e., worse outcomes). We examined the change in SPDSC scores from baseline to a 1 month follow-up.|CGI change scores from baseline to 1 month follow-up||||units on a scale||Standard Deviation|Mean
2738711|NCT00958880|Primary|The Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a self-report measure of social anxiety symptom severity. Scores range from 0 to 144, with higher scores indicating more social anxiety symptoms severity (i.e., a worse outcome).|LSAS means at 1 month follow-up||||units on a scale||Standard Deviation|Mean
2738712|NCT00958841|Secondary|Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.|||Participants|||Number
2738713|NCT00958841|Secondary|PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.|||Participants|||Number
2738714|NCT00958841|Secondary|PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.|||Participants|||Number
2738715|NCT00958841|Secondary|Percentage of Responders With Probability of Success at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.|||Percentage of participants|||Number
2738716|NCT00958841|Secondary|Percentage of Responders at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.|||percentage of participants|||Number
2738717|NCT00958841|Primary|Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)|The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.|||percentage of participants|||Number
2738718|NCT00958828|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per protocol|||Units on a scale||Standard Deviation|Mean
2738719|NCT00958789|Secondary|Knee Society Score (KSS) Change From Pre-op to Post-op Visits|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|pre-op, 1, 5 year|||||||
2761504|NCT00795951|Secondary|Persistent Reactions|Number of subjects who presented with persistent reactions|appear 2-4 days after patch application and last through 7-14 days after application||||participants|||Number
2738722|NCT00958789|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-op, 1, 2, 5 years|||||||
2738723|NCT00958789|Secondary|Revision Rates||5 years|||||||
2738724|NCT00958789|Secondary|Radiographic Stability|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. A migrating or shifting prosthesis, with or without the disappearance of radiolucent lines, should be considered as a possible or impending failure regardless of the score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Subsidence is defined as settling of the prosthetic component in bone, and is related to the distance between fixed bony landmarks on the tibia and the prosthesis.|1, 2, 5 years|||||||
2738725|NCT00958789|Secondary|Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-op, 1, 2, 5 years|||||||
2738726|NCT00958789|Secondary|The Effect of Joint Line Restoration on Post-op Stability, Anterior Knee Pain & Functional Performance.||2 years, 5 years|||||||
2738727|NCT00958789|Primary|Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years|"KSS Pain score, KSS Function score, Total Combined KSS~The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome.~Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200)."|pre-op, 2 years|KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 130.|||units on a scale|knees|Standard Deviation|Mean
2738728|NCT00958776|Other Pre-specified|Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial|Viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented as fold change from initial sensitivity by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.|||fold change||Standard Deviation|Mean
2738729|NCT00958776|Other Pre-specified|Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)|Initial viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.|||nM||Standard Deviation|Mean
2738730|NCT00958776|Other Pre-specified|Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Estimates and 95% confidence intervals were calculated using the method of Kaplan-Meier and presented by treatment group.|28 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||Percent Survival||95% Confidence Interval|Number
2738731|NCT00958776|Other Pre-specified|Number of Subjects Requiring More Than 5 Days of Study Drug|Subjects who had not met the protocol-defined criteria of clinical resolution on Day 5 or who had detectable virus by RT-PCR from a sample collected on Study Day 4 after dosing continued their assigned treatment for a further 5 days.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||participants|||Number
2738732|NCT00958776|Other Pre-specified|Incidence of Influenza-Related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis, and pneumonia as reported on the influenza-related complications CRF.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||participants|||Number
2738733|NCT00958776|Other Pre-specified|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||days||95% Confidence Interval|Median
2738744|NCT00958724|Secondary|Objective Response Rate (ORR)|Proportion of subjects who achieved complete response or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From first dose date to progression or last tumor assessment, up to 40 weeks.|Safety population|||percentage of participants||95% Confidence Interval|Number
2738734|NCT00958776|Secondary|Duration of All ICU Admissions (Kaplan-Meier Estimate)|Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||days||95% Confidence Interval|Median
2738735|NCT00958776|Secondary|Number of Subjects With ICU Admission|The number of subjects requiring ICU admission post-randomization was summarized by treatment group.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||participants|||Number
2738736|NCT00958776|Secondary|Time to Resumption of Usual Activities|Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||days||95% Confidence Interval|Median
2738737|NCT00958776|Secondary|Time to Resolution of Fever (Kaplan-Meier Estimate)|Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||hours||95% Confidence Interval|Median
2738738|NCT00958776|Secondary|Time to Alleviation of Clinical Symptoms of Influenza|Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||hours||95% Confidence Interval|Median
2738739|NCT00958776|Secondary|Change (Reduction) in Influenza Virus Titer|The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.|Baseline and 24, 48, 108 hours|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||log10 viral particles/mL||95% Confidence Interval|Median
2738740|NCT00958776|Primary|Time to Clinical Resolution (Kaplan-Meier Estimate)|Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain a NAI at randomization.|||hours||95% Confidence Interval|Median
2738741|NCT00958724|Secondary|Terminal-phase Elimination Half-life|Terminal-phase elimination half-life of Neratinib at day 8 following Administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m^2 to Japanese Subjects with Cancer.|Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.|Population for pharmacokinetic analyses consisted of all subjects in this study who received at least 1 dose of neratinib and provided samples for pharmacokinetic assessments.|||hr||Standard Deviation|Mean
2738742|NCT00958724|Secondary|Area Under the Curve (AUC) Tau|AUC of Neratinib at day 8 following administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m^2 to Japanese Subjects with Cancer.|Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.|Population for pharmacokinetic analyses consisted of all subjects in this study who received at least 1 dose of neratinib and provided samples for pharmacokinetic assessments.|||ng*hr/mL||Standard Deviation|Mean
2738743|NCT00958724|Secondary|Progression Free Survival|"Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment.~Disease Progression (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions."|From first dose to last evaluation, up to 40 weeks.|Subjects who met eligibility criteria, received at least 2 weeks of continual daily dosing of neratinib and at least 2 doses of vinorelbine, and underwent at least 1 follow-up tumor assessment at 6 weeks, i.e., approximately at cycle 2. In the case of disease progression prior to 6 weeks, a clinical assessment of PD was adequate.|||weeks||95% Confidence Interval|Median
2738797|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality||Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
2739140|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|6 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2738745|NCT00958724|Secondary|Duration of Objective Response|The duration of objective response was measured from the time at which measurement criteria were met for Complete Response (CR) or Partial Response (PR) (whichever status was recorded first) until the first date on which recurrence or Progressive Disease (PD) was objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.|From first response date to PD/death, up to 40 weeks.|Subjects who had a partial or complete response|||weeks||95% Confidence Interval|Median
2738746|NCT00958724|Secondary|Best Overall Response|Best Overall Response in Evaluable Population per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From first dose date to progression or last tumor assessment, up to 40 weeks.|Subjects who met eligibility criteria, received at least 2 weeks of continual daily dosing of neratinib, at least 2 doses of vinorelbine, and underwent at least 1 follow-up tumor assessment at 6 weeks, ie, approximately at cycle 2. In the case of disease progression prior to 6 weeks, a clinical assessment of progressive disease was adequate.|||Participants|||Count of Participants
2738747|NCT00958724|Primary|Dose Limiting Toxicity (DLT)|Number of participants experiencing DLT of neratinib in combination with vinorelbine in Japanese patients.|From first dose date to 21st day|Safety population|||participants|||Number
2738748|NCT00958711|Secondary|Ease of Dressing Use|Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult|Week 1 to Week 12|ITT. Note: Limited information available since product no longer licensed with Baxter. The only stats analysis information available provides data for Unite Biomatrix treatment arm, and will need to assume analysis was not performed for control arm.|||Score on a Scale||Standard Deviation|Mean
2738749|NCT00958711|Secondary|Number of Device Removals|Device removal is included in device failure under ITT. Subjects who experienced procedure-related events were also device failures under ITT. This endpoint is equivalent to device failure rates reported above.|Week 1 to Week 24|ITT|||Devices|||Number
2738750|NCT00958711|Secondary|Number of Device Failures|Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.|Week 1 to Week 24|ITT|||Devices|||Number
2738751|NCT00958711|Secondary|Number of Procedure-related Adverse Events (AE)||Week 1 to Week 24|ITT|||Events|||Number
2738752|NCT00958711|Secondary|Number of Device-related Adverse Events (AE)||Week 1 to Week 24|ITT|||Events|||Number
2738753|NCT00958711|Secondary|Number of Participants With Ulcer Recurrence||Week 1 to Week 24|ITT|||Participants|||Count of Participants
2738754|NCT00958711|Secondary|Percentage Mean of Original Wound Size From Baseline by Week|The percent of original wound size was calculated using the following formula: measure at baseline minus measure at follow-up visit divided by measure at baseline. In cases when the baseline depth was reported as 0cm, the minimum non-zero value in the sample (0.1cm) was imputed so a percent reduction measure could be calculated.|Day 0, Week 4, Week 8, Week 12|ITT|||Percentage mean of wound size||Standard Deviation|Mean
2738755|NCT00958711|Primary|Bacterial Burden||Day 0, Week 1 - Week 12|"Source document notes no data provided. Limited information available since product no longer licensed with Baxter."||||||
2738756|NCT00958711|Primary|Wound Healing Pathway Markers||Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4|"Source document notes no data provided. Limited information available since product no longer licensed with Baxter."||||||
2738757|NCT00958711|Primary|Percentage of Participants With Wounds Healed at 12 Weeks||Week 12|ITT|||Percentage of participants|||Number
2738758|NCT00958711|Primary|Percentage of Participants Not Healed by Number of Days After Procedure|Time to complete healing was captured by Kaplan-Meier Plot showing percentage of participants not healed by number of days after procedure. Patients were considered healed at their first follow-up visit where the patient's would had healed.|Day 20, Day 40, Day 60, Day 80|Intent-to-Treat (ITT): all randomized participants who provided consent..|||Percentage of Participants|||Number
2738759|NCT00958581|Secondary|Length of Hospital Stay From Admission Until Patient Discharge||1 week|Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.||||||
2738760|NCT00958581|Secondary|Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge)||1 week|Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.||||||
2738761|NCT00958581|Primary|Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)||1 Week||||ml||Standard Deviation|Mean
2738762|NCT00958568|Other Pre-specified|Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)|Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 27|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2738763|NCT00958568|Secondary|Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram||Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.|||percentage of participants|||Number
2738846|NCT00958360|Secondary|Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
2738764|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)|Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval <500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.|Randomization (Week 20) to Week 47|All randomized participants who had <500 msec QTc interval at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.|||percentage of participants|||Number
2738765|NCT00958568|Secondary|Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram|Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.|||milliseconds (msec)||Standard Error|Least Squares Mean
2738766|NCT00958568|Secondary|Percent of Participants With Suicide-Related Thoughts and Behaviors|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) C-SSRS measurements.|||percentage of participants|||Number
2738767|NCT00958568|Secondary|Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%||Week 20 to Week 47|All randomized participants who had Week 20 and at least 1 post-baseline (Weeks 21-47) weight measurements.|||percentage of participants|||Number
2738768|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Weight|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) weight measurements.|||kilograms (kg)||Standard Error|Least Squares Mean
2738769|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Glucose|Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and <126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: <100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is <100 mg/dL at baseline, ≥100 mg/dL and <126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: <126 mg/dL at baseline and ≥126 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had impaired or normal glucose value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.|||percentage of participants|||Number
2738770|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Glucose|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2738771|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Triglycerides|Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and <200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: <150 mg/dL at baseline, ≥150 mg/dL and <200 mg/dL any time post baseline; Normal to High fasting triglycerides: <150 mg/dL at baseline and ≥200 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal triglycerides value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglyceride measurements.|||percentage of participants|||Number
2738772|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Triglycerides|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglycerides measurement.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2738773|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Hepatic Events|Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 times the upper limit of normal (ULN) at baseline, with ALT or AST >=3 times the ULN post-baseline and total bilirubin >=2 times ULN at the same time are considered having treatment-emergent hepatic events.|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and post-baseline (Weeks 21-47) hepatic function measurements.|||percentage of participants|||Number
2738774|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol|Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and <40 mg/dL anytime post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had normal HDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.|||percentage of participants|||Number
2738775|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2738806|NCT00958477|Secondary|Time to Progression (TTP)|TTP was calculated as the time between the date of imaging for the earliest visit where progressive disease was detected and the first dose date plus 1 day. Participants without event are censored on the date of last tumor assessment.|Baseline up to disease progression up to a maximum of 13.1 months|Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here “Number of Participants” analyzed signifies those subjects who were evaluable for this outcome measure.|||months|||Number
2738776|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol|Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and <160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: <100 mg/dL at baseline, ≥100 mg/dL and <160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: <100 mg/dL at baseline and ≥160 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal LDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.|||percent of participants|||Number
2738777|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2738778|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol|Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and <240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: <200 mg/dL at baseline, ≥200 mg/dL and <240 mg/dL any time post baseline; Normal to High fasting total cholesterol: <200 mg/dL at baseline and ≥240 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal cholesterol level at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.|||percentage of participants|||Number
2738779|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2738780|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Dyskinesia|Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) AIMS measurements.|||percentage of participants|||Number
2738781|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Parkinsonism|Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score >3 of items 1 through 10 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) Simpson-Angus Scale measurements.|||percentage of participants|||Number
2738782|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Akathisia|Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS <2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) BAS measurements.|||percentage of participants|||Number
2738783|NCT00958568|Secondary|Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) SDS score measurements. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Error|Least Squares Mean
2738784|NCT00958568|Secondary|Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)|Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.|Randomization (Week 20) to Week 47|All randomized participants who provided information of psychiatric visits and emergency room or equivalent facility visits for psychiatric illness from Week 21 to Week 47.|||visits per participant||Standard Deviation|Mean
2738785|NCT00958568|Secondary|Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47||Week 47|All randomized participants who worked for pay at Week 47.|||hours||Standard Deviation|Mean
2738847|NCT00958360|Primary|Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
2738786|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) CGI-S measurements.|||units on a scale||Standard Error|Least Squares Mean
2738787|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements. LOCF principle was used.|||units on a scale||Standard Error|Least Squares Mean
2738788|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements.|||units on a scale||Standard Error|Least Squares Mean
2738789|NCT00958568|Secondary|Percentage of Participants Maintaining Remission|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
2738790|NCT00958568|Secondary|Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).|||percentage of participants|||Number
2738791|NCT00958568|Secondary|Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).|||percentage of participants|||Number
2738792|NCT00958568|Secondary|Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 0 to Week 8|All participants who entered open-label acute treatment phase (SPII).|||percentage of participants|||Number
2738793|NCT00958568|Secondary|Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|"Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 197 and 160 for OFC and Flu groups, respectively.|||days||Full Range|Median
2738794|NCT00958568|Secondary|Time to Relapse as Measured by Hospitalization for Depression or Suicidality|"Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 217 and 220 for OFC and Flu groups, respectively.|||days||Full Range|Median
2738795|NCT00958568|Secondary|Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|"Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 190 and 160 for OFC and Flu groups, respectively.|||days||Full Range|Median
2738796|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
2738798|NCT00958568|Secondary|Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
2738799|NCT00958568|Secondary|Percentage of Participants Who Relapse by Any Criteria|Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
2738800|NCT00958568|Primary|Time to Relapse by Any Criteria|"Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 186 and 152 for OFC and Flu groups, respectively.|||days||Full Range|Median
2738801|NCT00958477|Secondary|Minimum Percent Change From Baseline in PSA Level|Minimum percent change from Baseline in PSA Level during the study was reported.|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||percent change||Standard Deviation|Mean
2738802|NCT00958477|Secondary|Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level|Maximum percent change from Baseline in PSA Level during the study was reported.|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||percent change||Standard Deviation|Mean
2738803|NCT00958477|Secondary|Total Pain Score Using Brief Pain Inventory-Short Form (BPI-sf)|"BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf has 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10;'0=No pain and 10=Pain as bad as you can imagine'.Total score is reported as average of individual questions ranges from 0 to 10, with lower scores being indicative of less pain or pain interference.Data was not available for EMD 525797 250 mg arm for FUP Weeks 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 and EMD 525797 1000 mg arm for FUP Weeks 47, 51, 55, 59, 63, 67, 71 and EMD 525797 1500 mg arm for FUP Weeks 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 respectively as no subjects were evaluable at the specified FUP visits."|Screening; Baseline; Week 3, 5, 7; Follow-up (FUP) Week 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75; End of treatment (EOT; maximum up to 380 days) and EOS (maximum up to 394 days)|"Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here n signifies those subjects who were evaluable for this outciome measure at the specified time points."|||score on a scale||Standard Deviation|Mean
2738804|NCT00958477|Secondary|Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score|ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. best post-baseline value (i.e. lowest score) combination.|Baseline up to 394 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||subjects|||Number
2738805|NCT00958477|Secondary|Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score|ECOG performance status measured to assess subject's performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. worst post-baseline value (i.e. highest score) combination.|Baseline up to 394 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||subjects|||Number
2738807|NCT00958477|Secondary|Progression-free Survival (PFS) as Per Prostate Cancer Clinical Trials Working Group 1 (PCWG1) and Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria|PFS PCWG1 criteria: time from the day treatment is initiated up to progression (for subject's whose prostate specific antigen [PSA] level did not decrease after baseline, progression defined as 50% PSA increase relative to baseline; for subject's whose PSA decreased after baseline, progression defined as 50% PSA increase relative to nadir [smallest PSA value post-baseline]. Progression was confirmed if progression criterion was met in next 2 assessments as well.) PFS PCWG2 criteria: time from study entry to disease progression or death. Progression was defined as first appearance of progression according to PSA (for subject's whose PSA decreased after baseline, progression was defined as 25% PSA increase relative to nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well; for subject's whose PSA did not decrease after baseline, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline).|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||months||95% Confidence Interval|Median
2738808|NCT00958477|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Week 6, Week 19, Overall (Baseline Up to 394 days)|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||subjects|||Number
2738809|NCT00958477|Secondary|Accumulation Ratio of AUC (R_AUC)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|pre-dose, end of infusion, 4, 8, 24, 48, 96,168 hours post-infusion at Week 1 and pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2738810|NCT00958477|Secondary|Accumulation Ratio Of Cmax (R_Cmax)|Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 and Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2738811|NCT00958477|Secondary|Apparent Volume of Distribution at Steady State (Vss) of EMD 525797 After Third Infusion|Apparent volume of distribution at steady-state was reported. Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2738812|NCT00958477|Secondary|Mean Residence Time of Drug in the Body (MRT) of EMD 525797 After First Infusion|Mean residence time of drug in the body calculated as: AUMC0-inf / AUC0-inf, where AUMC0-inf is the area under the first moment curve from time zero to infinity. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||hours||Geometric Coefficient of Variation|Geometric Mean
2738813|NCT00958477|Secondary|Peak Trough Fluctuation Over One Dosing Interval at Steady State (%PTF) of EMD 525797 After Third Infusion|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [ Cmax - Cmin ] / Cav )*100|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||percentage of fluctuation||Geometric Coefficient of Variation|Geometric Mean
2738826|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
2738848|NCT00958347|Primary|Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.||25 Years Post-Operatively|The study was closed and no subjects reached the 25 year postoperative endpoint.||||||
2738814|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of EMD 525797 After First Infusion|Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2738815|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After Third Infusion|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96,168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2738816|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (168 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2738817|NCT00958477|Secondary|Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion|The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (336 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2738818|NCT00958477|Secondary|Observed Minimum Serum Concentration (Cmin) of EMD 525797 After Third Infusion|Observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
2738819|NCT00958477|Secondary|Elimination Rate Constant (λz) of EMD 525797 After First Infusion|Elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||1/h||Geometric Coefficient of Variation|Geometric Mean
2738820|NCT00958477|Secondary|Apparent Terminal Half-life (t1/2) of EMD 525797 After First Infusion|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||hours||Full Range|Median
2738821|NCT00958477|Secondary|C-Reactive Protein Levels||Week 1 up to a maximum of 56 days|As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.||||||
2738822|NCT00958477|Secondary|Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8)||Week 1 up to a maximum of 56 days|As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.||||||
2738823|NCT00958477|Secondary|Number of Subjects With Positive Anti-EMD 525797 Antibodies||Week 1, 3, 5, 8, 9|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||Subjects|||Number
2738824|NCT00958477|Secondary|Time to Reach Observed Serum Concentration (Tmax) After Third Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
2738825|NCT00958477|Secondary|Time to Reach Observed Serum Concentration (Tmax) After First Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||hours||Full Range|Median
2738827|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 3|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
2738828|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 1|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
2738829|NCT00958477|Primary|Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as = Dose/(AUC0-inf *λz) after first infusion. Where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||Liters||Geometric Coefficient of Variation|Geometric Mean
2738830|NCT00958477|Primary|Total Body Clearance of Drug From Serum (CL) After First Infusion|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Total body clearance of drug from serum, calculated as CL = dose/AUC0-inf. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||L/h||Geometric Coefficient of Variation|Geometric Mean
2738831|NCT00958477|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2738832|NCT00958477|Primary|Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2738833|NCT00958477|Primary|Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"Pharmacokinetic (PK) analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797.Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2738834|NCT00958477|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug.|Baseline up to 534 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||Subjects|||Number
2738845|NCT00958360|Secondary|Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
2761505|NCT00795951|Secondary|Late Reactions|Number of subjects who presented with late reactions|7-10 days after patch application||||participants|||Number
2738835|NCT00958477|Primary|Number of Subjects With Dose Limiting Toxicity (DLT)|DLT was defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 as any Grade 3 or 4 hematological or non-hematological toxicity occurring at any dose level until the end of Week 6, and suspected to be reasonably related to the investigational product by the Investigator and/or Sponsor except for allergic/ hypersensitivity reactions and any Grade 3/4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days.|Baseline up to 6 weeks|DLT analysis set: all subjects who experienced any DLT during first 6 weeks, regardless of number of doses of drug administered or who were considered completers (did not discontinue treatment for any reason other than DLT, were compliant, did not deviate in drug administration for more than +/-2 days due to any reason other than related toxicity).|||subjects|||Number
2738836|NCT00958438|Secondary|Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flare days||Standard Deviation|Mean
2738837|NCT00958438|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flare days per participant was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flare days||Standard Deviation|Mean
2738838|NCT00958438|Secondary|Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
2738839|NCT00958438|Secondary|Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
2738840|NCT00958438|Secondary|Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)|Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flares||Standard Deviation|Mean
2738841|NCT00958438|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flares||Standard Deviation|Mean
2738842|NCT00958412|Primary|To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily|Number of participants who experienced 1 or more adverse event.|6 months||||Participants|||Number
2738843|NCT00958360|Secondary|Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
2738844|NCT00958360|Secondary|Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
2738849|NCT00958334|Secondary|Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only)|Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood.|Baseline, 14 months, 17 months|Intent to treat population|||mL of Blood||Standard Deviation|Mean
2738850|NCT00958334|Primary|The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.|An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.|Baseline to 17 months|Intent to treat population|||mL||Standard Deviation|Mean
2738851|NCT00958308|Secondary|Frequencies of Other Gastrointestinal Symptoms.|Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.|Up to 40 days|||||||
2738852|NCT00958308|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.|Adverse events were reported by patients in the three study groups.|Up to 40 days|||||||
2738853|NCT00958308|Secondary|Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.|If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.|Up to 40 days|||||||
2738854|NCT00958308|Secondary|Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.|Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.|Up to 40 days|||||||
2738855|NCT00958308|Primary|To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.|Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.|Up to 40 days||||participants|||Number
2738856|NCT00958282|Secondary|Drug Craving|"On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale.~The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much."|14 Weeks||||units on a scale||Standard Error|Mean
2738857|NCT00958282|Primary|Cocaine-positive Urine Results|At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.|14 Weeks||||percentage of BE urine tests||Standard Deviation|Mean
2738858|NCT00958256|Primary|Response Rate|Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.|Evaluation of disease after 2 cycles (approximately 6 weeks).|Twenty-one patients were evaluable for response assessment (100%), of whom 16 responded (76%) thus reflected are the percentage of responses to total responders (i.e. 11 (52%) of total evaluable achieved a complete response).|||percentage of participants|||Number
2738859|NCT00958243|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|Up to 180 days after the last vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
2738860|NCT00958243|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"UAE grading:~Grade 1: Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities."|During the 21 days after each vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
2738861|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination.|||Days||Standard Deviation|Mean
2738862|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination||21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
2738966|NCT00957801|Primary|Hematocrit Measured on Treatment Day 8 (Post Study)|Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.|treatment day 8||||percent||Standard Deviation|Mean
2738863|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination||21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
2738864|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
2738865|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination.|||Days||Standard Deviation|Mean
2738866|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
2738867|NCT00958243|Primary|Seroconversion Rate 21 Days After Second Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
2738868|NCT00958243|Primary|Seroconversion Rate 21 Days After First Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
2738869|NCT00958217|Primary|Timeline Followback|The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.|Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)||||proportion of days abstinent||Standard Deviation|Mean
2738870|NCT00958217|Primary|Posttraumatic Stress Disorder (PTSD) Symptoms|The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)||||units on a scale||Standard Deviation|Mean
2738880|NCT00958191|Secondary|Linear Wear Rate of the Trident X3 Polyethylene Insert|"Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period.~NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear."|2, 3 and 4 year films collected; 3 and 4 year wear assessed|Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.|||mm/year|Hips|Standard Deviation|Mean
2738871|NCT00958217|Primary|Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.|Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)||||units on a scale||Standard Deviation|Mean
2738872|NCT00958191|Secondary|Implant Survivorship|Implant survivorship is determined using the Kaplan-Meier method.|10 years|"Participants with available data. The population includes all 240 cases who were initially consented to 5 year study.~There are 127 cases who consented to continue in the 10 year study."|||percentage of hips|hips||Number
2738873|NCT00958191|Secondary|Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change|Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2738874|NCT00958191|Secondary|Mean SF-12 Health Survey Score to Assess Change|Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2738875|NCT00958191|Secondary|Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change|"The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.~211-300 degrees = 5 points~161 to 210 degrees = 4 points~101 to 160 degrees = 3 points~61 to 100 degrees = 2 points~31 to 60 degrees = 1 points~0 to 30 degrees = 0 points"|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2738876|NCT00958191|Secondary|Mean Harris Hip Score (HHS) Pain Score to Assess Change|"The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.~None or ignores it = 44 points~Slight, occasional, no compromise in activities = 40 points~Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points~Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points~Marked pain, serious limitation of activites = 10 points~Totally disabled, crippled, pain in bed, bedridden = 0 points"|pre-operative, 1,3, and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2738877|NCT00958191|Secondary|Mean Harris Hip Score (HHS) to Assess Change|"The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
2738878|NCT00958191|Secondary|Radiographic Stability|Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.|1,2,3,4 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the 1 year population.|||hips evaluated as unstable on radiograph|Hips||Number
2738879|NCT00958191|Secondary|Volumetric Wear Rate of the Trident X3 Polyethylene Insert|"Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate.~NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear."|2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed|Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.|||cubic mm/year|Hips||Number
2738921|NCT00957944|Secondary|AUC(0-∞) Norm (BW)|The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h*kg||Standard Deviation|Mean
2738881|NCT00958191|Primary|Rate of Incidence of Revision of Component for Any Reason|Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.|5 year|Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head & stem but later withdrew from the study & is included in the withdrawal category of the participant flow.|||percentage of hips undergoing revision|Hips||Number
2738882|NCT00958191|Primary|Mean Linear Wear Rate at 5 Years|Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years|5 years||||mm/year|Hips|Standard Deviation|Mean
2738883|NCT00958165|Primary|Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.||12 months|Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.|||Successful participants|||Number
2738884|NCT00958126|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"Unsolicited adverse event (UAE) grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities."|Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.|||percentage of participants|||Number
2738885|NCT00958126|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.|||percentage of participants|||Number
2738886|NCT00958126|Primary|Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2738887|NCT00958126|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2738888|NCT00958126|Primary|Seroconversion Rate 21 Days After the Second Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2738889|NCT00958126|Secondary|Duration of Solicited Local Adverse Events After the First Vaccination||During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.|||days||Standard Deviation|Mean
2738890|NCT00958126|Secondary|Frequency and Intensity of Solicited Adverse Events After the First Vaccination|Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.|During the 7 days after the first vaccination|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.|||percentage of participants|||Number
2738891|NCT00958126|Primary|Seroconversion Rate 21 Days After the First Vaccination|Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2738892|NCT00958074|Secondary|Changes in the Physicians Serial Assessment of Erythroderma Score||Baseline to 30 days post-treatment|2 subjects >= 65, 3 subjects <= 65 with baseline erythroderma score.|||Participants|||Count of Participants
2738893|NCT00958074|Secondary|Number of Participants With Overall Response as Measured by Sezary Cell Count|Overall response defined by a clinically significant decrease in Sezary cell count (>50% decrease from baseline).|Baseline to 30 days post-treatment||||participants|||Number
2738894|NCT00958074|Secondary|Occurrences of Dose Adjustment as Measured by Safety/Toxicity|Toxicities will be graded in severity according to the guidelines outlined in the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|Up to 30 days post-treatment|4 subjects >= 65, 7 subjects <= 65 who received at least one dose of drug.|||Occurrences|||Number
2763909|NCT00781950|Primary|Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions||1 year||||participants|||Number
2738895|NCT00958074|Secondary|Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);|Assessed by changes in the sum of the products in the greatest diameters of enlarged lymph nodes by serial computed tomography (CT) or positron emission tomography (PET)/CT scans.|Up to 30 days post-treatment|7 subjects with nodal disease (2 subjects >=65 and 5 subjects <= 65: 1 not evaluable)|||participants|||Number
2738896|NCT00958074|Primary|Objective Response|Defined as either no evidence of clinical disease or marked improvement (>= 50%) decrease in the modified Severity-Weighted Assessment Tool (mSWAT) skin assessment score compared to baseline.|After at least 14 days. With Confirmation after additional 28 days.|In cohort 1, only 3 of the 4 subjects consented were used for analysis. 1 patient in this cohort only completed 3 days of treatment before removing themselves from treatment and withdrawing consent. This patient was deemed inevaluable, as the timeframe for initial evaluation is 14 days.|||percentage of total|||Number
2738897|NCT00958035|Primary|Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4|Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).|Month 4|Intent-to-Treat: All randomized subjects|||Percentage of Patients|||Number
2738898|NCT00958009|Secondary|Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.|The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.|||Proportion of subjects||95% Confidence Interval|Mean
2738899|NCT00958009|Primary|Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire|Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.|||Proportion of subjects||95% Confidence Interval|Mean
2738900|NCT00957996|Secondary|Survival (Kaplan-Meier Estimates)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.|14 and 28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||Percent Survival||95% Confidence Interval|Number
2738901|NCT00957996|Other Pre-specified|Number of Participants Who Required More Than 5 Days of Peramivir Treatment|The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
2738902|NCT00957996|Secondary|Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)|The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||days||95% Confidence Interval|Median
2738903|NCT00957996|Secondary|Number of Participants Admitted to ICU After Initiation of Treatment|The number of subjects experiencing ICU admission after initiation of treatment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
2738904|NCT00957996|Secondary|Number of Participants Experiencing Influenza-related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
2738905|NCT00957996|Secondary|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||days||95% Confidence Interval|Median
2738906|NCT00957996|Secondary|Time to Resumption of Usual Activities|Subject's ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||hours||95% Confidence Interval|Median
2738907|NCT00957996|Secondary|Time to Resolution of Fever|Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||hours||95% Confidence Interval|Median
2738908|NCT00957996|Secondary|Time to Alleviation of Symptoms|Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.|||hours||95% Confidence Interval|Median
2738909|NCT00957996|Secondary|Number of Participants With Clinical Resolution|Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
2738910|NCT00957996|Secondary|Time to Clinical Resolution|Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||hours||95% Confidence Interval|Median
2738911|NCT00957996|Secondary|Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)|The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline, 48, 108, 216 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).|||log10 viral particles/mL||95% Confidence Interval|Median
2738912|NCT00957996|Primary|Change From Baseline in Influenza Virus Titer (48 Hours)|The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline and 48 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).|||log10 TCID50/mL||95% Confidence Interval|Median
2738913|NCT00957944|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)|||mg||Standard Deviation|Mean
2738914|NCT00957944|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||L/h||Standard Deviation|Mean
2738915|NCT00957944|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
2738916|NCT00957944|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||1/ hour (1/h)||Standard Deviation|Mean
2738917|NCT00957944|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
2738918|NCT00957944|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Full Range|Median
2738919|NCT00957944|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL) * kg||Standard Deviation|Mean
2738920|NCT00957944|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)/ mg||Standard Deviation|Mean
2763099|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||3 months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
2738922|NCT00957944|Secondary|AUC(0-∞) Norm (Apparent Dose)|The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
2738923|NCT00957944|Secondary|AUC(0-tz) Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h*kg||Standard Deviation|Mean
2738924|NCT00957944|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
2738925|NCT00957944|Primary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
2738926|NCT00957944|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||ng/ mL||Standard Deviation|Mean
2738927|NCT00957944|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
2738928|NCT00957931|Secondary|Count of Participants With Disease-free Survival 1 Year Following HCT|Disease-free survival is defined as alive without underlying disease.|1 year||||Participants|||Count of Participants
2738929|NCT00957931|Secondary|Count of Participants With Disease-free Survival 6 Months Following HCT|Disease-free survival is defined as alive without underlying disease.|6 months||||Participants|||Count of Participants
2738930|NCT00957931|Secondary|Overall Survival 1 Year Following HCT|Overall survival is reported at the count of participants alive 1 year following HCT.|1 year||||Participants|||Count of Participants
2738931|NCT00957931|Secondary|Overall Survival 6 Months Following HCT|Overall survival is reported at the count of participants alive 6 months following HCT.|6 months||||Participants|||Count of Participants
2738932|NCT00957931|Primary|Count of Participants With Stable Engraftment Post Hematopoietic Cell Transplantation (HCT)|Stable engraftment was defined as absolute neutrophil count (ANC) >500 cells /µL for 3 consecutive days and platelet count >50,000 for one week without transfusion; subsequently stable engraftment was measured by percentage of donor cells.|Up to 1 year||||Participants|||Count of Participants
2738933|NCT00957905|Other Pre-specified|Time to Tumor Response||From treatment start until first documented CR or PR, assessed up to 4 years|||||||
2738934|NCT00957905|Other Pre-specified|Progression-free Survival||From treatment start until first documented progression or death, assessed up to 4 years|||||||
2738935|NCT00957905|Other Pre-specified|Toxicity|graded using the NCI CTCAE version 4.0.See adverse event section|Up to 4 years|||||||
2738936|NCT00957905|Primary|Objective Response Rate|"Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Within 3 courses of treatment||||participants|||Number
2738937|NCT00957853|Secondary|Number of Participants With Objective Response|Objective response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 4 months post treatment start||||Participants|||Count of Participants
2738938|NCT00957853|Primary|AKT Modulation|An IHC scoring system used to quantify phospho-Akt levels based on staining intensity x extension. Staining intensity graded as undetectable (0), weak (1), medium (2), or strong (3). Staining extension graded as percentage of positive cells per high power field at x20 magnification. Final score will therefore range from 0 to 300. Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy) and other biomarkers compared between any two of the three treatment arms with the use of the Wilcoxon rank sum test. Type I error of alpha=0.05 (two-sided test) used. Correlation between biomarkers and molecular response or toxicity performed in an exploratory fashion.|Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)|Due to early termination of the study, data could not be collected for this outcome.||||||
2738939|NCT00957827|Primary|Infection|Presence or absence of infection|one week|Not evaluated due to low enrollment/This should be reflected in all data fields||||||
2738940|NCT00957801|Primary|Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8."|Study days 1-7 (treatment week)|1 subject did not complete the BFI during treatment week.|||units on a scale||Standard Deviation|Mean
2738941|NCT00957801|Primary|Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1."|Study days -7 to -1 (Pre - treatment)||||units on a scale||Standard Deviation|Mean
2738942|NCT00957801|Primary|Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 8 - after exercise||||ug/dL||Standard Deviation|Mean
2738943|NCT00957801|Primary|Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 8 - before exercise||||ug/dL||Standard Deviation|Mean
2738944|NCT00957801|Primary|Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 1 - after exercise||||ug/dL||Standard Deviation|Mean
2738945|NCT00957801|Primary|Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 1 - before exercise||||ug/dL||Standard Deviation|Mean
2738946|NCT00957801|Primary|Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)|Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.|treatment day 8||||ng/mL||Standard Deviation|Mean
2738947|NCT00957801|Primary|Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)|Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.|treatment day 1||||ng/mL||Standard Deviation|Mean
2738948|NCT00957801|Primary|Insulin Measured on Treatment Day 8 (Post Study)|Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.|treatment day 8||||uIu/mL||Standard Deviation|Mean
2738949|NCT00957801|Primary|Insulin Measured on Treatment Day 1 (Baseline Study)|Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.|treatment day 1||||uIu/mL||Standard Deviation|Mean
2738950|NCT00957801|Primary|Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)|Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.|treatment day 8||||nmol/L||Standard Deviation|Mean
2738951|NCT00957801|Primary|Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)|Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.|treatment day 1||||nmol/L||Standard Deviation|Mean
2738952|NCT00957801|Primary|Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)|Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.|treatment day 8||||ug/dL||Standard Deviation|Mean
2738953|NCT00957801|Primary|Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)|Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.|treatment day 1||||ug/dL||Standard Deviation|Mean
2738954|NCT00957801|Primary|C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)|C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
2738955|NCT00957801|Primary|C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)|C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
2738956|NCT00957801|Primary|Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)|Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
2738957|NCT00957801|Primary|Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)|Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
2738958|NCT00957801|Primary|Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)|Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
2738959|NCT00957801|Primary|Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)|Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
2766104|NCT00765388|Secondary|Problems With Splashing Sounds During Use|The patient was asked whether he/she noticed any splashinh sounds during use|4 weeks|ITT population|||Participants|||Number
2738968|NCT00957801|Primary|Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)|Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.|treatment day 8||||ng/mL||Standard Deviation|Mean
2738969|NCT00957801|Primary|Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)|Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.|treatment day 1||||ng/mL||Standard Deviation|Mean
2738970|NCT00957801|Primary|Serum Estradiol Measured on Treatment Day 8 (Post Study)|Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.|treatment day 8||||pg/mL||Standard Deviation|Mean
2738971|NCT00957801|Primary|Serum Estradiol Measured on Treatment Day 1 (Baseline Study)|Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.|treatment day 1||||pg/mL||Standard Deviation|Mean
2738972|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 8 (Post Study)|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 8||||ng/dL||Standard Deviation|Mean
2738973|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 7|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 7||||ng/dL||Standard Deviation|Mean
2738974|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 6|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 6||||ng/dL||Standard Deviation|Mean
2738975|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 5|"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 5||||ng/dL||Standard Deviation|Mean
2738976|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 4|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 4|One subject missed a testosterone monitoring visit for treatment day 4.|||ng/dL||Standard Deviation|Mean
2738977|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 3|"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 3||||ng/dL||Standard Deviation|Mean
2738978|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 2|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 2||||ng/dL||Standard Deviation|Mean
2738979|NCT00957801|Primary|Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 1||||ng/dL||Standard Deviation|Mean
2738980|NCT00957723|Secondary|Implant Survivorship|Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.|10 years|Participants with available data.|||percentage of knees|knees||Number
2738981|NCT00957723|Secondary|Patient Outcome Long Term Follow-up Questionnaire Over Time|"Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions:~Do you have any pain in your knee that has the study knee replacement?~Are you satisfied with the results of your study total knee replacement?~Have you had any surgery on your study knee since the time of your last study required visit/contact?"|6, 7, 8, 9, and 10 years|Participants/knees with available data. Overall number of participants and units analyzed is based upon the eight year postoperative population, as this was the largest available population between the 6-10 year postoperative intervals.|||knees|knees||Count of Units
2738982|NCT00957723|Secondary|Patellar Subluxation, Dislocation and Fracture Rate|The incidence of patellar subluxation, dislocation or fracture is reported.|5 years|Participants/knees with available data at 5 years.|||knees|knees||Count of Units
2738983|NCT00957723|Secondary|Change in Lower-Extremity Activity Scale (LEAS) Over Time|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|preoperative, 1, 2, 3, 4, and 5 years|Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|knees|Standard Deviation|Mean
2738984|NCT00957723|Secondary|Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|preoperative,1, 2, 3, 4 and 5 years|Participants/knees with available data. Data for the WOMAC is only available at the 2, 3, 4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison.|||units on a scale|knees|Standard Deviation|Mean
2739141|NCT00957359|Primary|HADS Anxiety|Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)|1 day post drug administration 1||||score on a scale||Standard Error|Mean
2738985|NCT00957723|Secondary|Change in SF-36 Health Survey Over Time|The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|preoperative, 1, 2, 3, 4, and 5 years|Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|knees|Standard Deviation|Mean
2738986|NCT00957723|Secondary|Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.|1, 2, and 5 years|Participants/knees with available data. Overall number of participants and units analyzed is based upon the one year population.|||Total number of knees|knees||Number
2738987|NCT00957723|Secondary|Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)|Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.|1, 2, and 5 years|Participants/knees with available data. Overall number of participants and units analyzed is based upon preoperative population.|||degrees|knees|Standard Deviation|Mean
2738988|NCT00957723|Secondary|Change in Knee Society Score (KSS) Over Time|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|preoperative, 1, 2, and 5 years|Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|knees|Standard Deviation|Mean
2738989|NCT00957723|Primary|Active Range of Motion||2 Years|Participants/knees with available data.|||Degrees|knees|Standard Deviation|Mean
2738990|NCT00957684|Primary|Part I: Seizure Frequency|"The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the intention-to-treat (ITT) population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.to a frequency per 4 weeks basis"|12-week maintenance period|The primary efficacy analysis was based on the ITT population.|||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
2738991|NCT00957671|Secondary|Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|one year|This data is for the 5 female subjects enrolled in this study.|||percent of body fat||Standard Deviation|Mean
2738992|NCT00957671|Secondary|Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|baseline|This data is for the 5 female subjects enrolled in the study.|||percent of body fat||Standard Deviation|Mean
2738993|NCT00957671|Secondary|Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy|Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.|one year|This is the data for the 5 female subjects.|||kilograms||Standard Deviation|Mean
2738994|NCT00957671|Secondary|Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.|baseline|This data is for the 5 female subjects in the study.|||kilograms||Standard Deviation|Mean
2738995|NCT00957671|Secondary|Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This data is for the 5 female subjects in the study.|||kilograms||Standard Deviation|Mean
2738996|NCT00957671|Secondary|Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.|baseline|This data is for the 5 female subjects in the study.|||kilograms||Standard Deviation|Mean
2738997|NCT00957671|Secondary|Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy|Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This data represents the 5 females in the study.|||kilograms||Standard Deviation|Mean
2738998|NCT00957671|Secondary|Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.||baseline|This is the data for the 5 females in the study.|||kilograms||Standard Deviation|Mean
2738999|NCT00957671|Secondary|Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.|Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.|one year||||units on a scale||Standard Deviation|Mean
2739020|NCT00957671|Secondary|Fatigue as Measured Using Fatigue Severity Scale at Baseline.|Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.|baseline||||scores on a scale||Standard Deviation|Mean
2739000|NCT00957671|Secondary|Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.|Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.|baseline||||units on a scale||Standard Deviation|Mean
2739001|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|one year|This data is for the 5 female subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
2739002|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|baseline|This data is for the 5 female subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
2739003|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy|Maximum torque production during isometric contraction of the knee extensor muscles.|one year|This data is for the 5 female subjects in the study.|||Newton-Meters||Standard Deviation|Mean
2739004|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.|Maximum torque production during isometric contraction of the knee extensor muscles.|baseline|This data is for the 5 female subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
2739005|NCT00957671|Secondary|Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|one year|This data is for the 10 male subjects in the study.|||percent of body fat||Standard Deviation|Mean
2739006|NCT00957671|Secondary|Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|baseline|This data is for the 10 male subjects enrolled in this study.|||percent of body fat||Standard Deviation|Mean
2739007|NCT00957671|Secondary|Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.|one year|This is the data for the 10 male subjects enrolled in the study.|||kilogram||Standard Deviation|Mean
2739008|NCT00957671|Secondary|Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.|baseline|This data is for the 10 male subjects enrolled in this study.|||kilograms||Standard Deviation|Mean
2739009|NCT00957671|Secondary|Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This data is for the 10 male subjects enrolled in the study.|||kilograms||Standard Deviation|Mean
2739010|NCT00957671|Secondary|Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|baseline|This data is for the 10 male subjects enrolled in this study.|||kilograms||Standard Deviation|Mean
2739011|NCT00957671|Secondary|Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This is the data for the 10 male subjects in the study.|||kilograms||Standard Deviation|Mean
2739012|NCT00957671|Secondary|Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.|baseline|This data is for the 10 male subjects in the study.|||kilograms||Standard Deviation|Mean
2739013|NCT00957671|Secondary|Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.|Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.|one year||||Percent of Maximum Torque||Standard Deviation|Mean
2739014|NCT00957671|Secondary|Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.|Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.|baseline||||Percent of Maximum Torque||Standard Deviation|Mean
2739015|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|one year|This data is for the 10 male subjects in this study.|||Newton-Meters||Standard Deviation|Mean
2739016|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|baseline|This data is for the 10 male subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
2739017|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.|Maximum torque production during isometric contraction of the knee extensor muscles.|one year|This is the data for the 10 male subjects in this study.|||Newton-Meters||Standard Deviation|Mean
2739018|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.|Maximum torque production during isometric contraction of the knee extensor muscles.|baseline|This is the data for the 10 male subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
2739019|NCT00957671|Secondary|Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.|Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.|one year||||scores on a scale||Standard Deviation|Mean
2739021|NCT00957671|Secondary|Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.|Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.|one year||||scores on a scale||Standard Deviation|Mean
2739022|NCT00957671|Secondary|Depression as Measured by the Beck Depression Inventory at Baseline.|Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.|baseline||||scores on a scale||Standard Deviation|Mean
2739023|NCT00957671|Secondary|Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy|Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.|one year||||scores on a scale||Standard Deviation|Mean
2739024|NCT00957671|Secondary|Neuropsychological Function as Measured by Letter Fluency at Baseline|Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.|baseline||||scores on a scale||Standard Deviation|Mean
2739025|NCT00957671|Secondary|Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.|"Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.~This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work NO. Total correct responses for both task within 120 seconds are recorded.~Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome."|one year||||scores on a scale||Standard Deviation|Mean
2739026|NCT00957671|Secondary|Neuropsychological Function as Measured by Processing Speed Index at Baseline|"Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.~This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work NO. Total correct responses for both task within 120 seconds are recorded.~Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome."|baseline||||scores on a scale||Standard Deviation|Mean
2739027|NCT00957671|Secondary|Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.|Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.|one year||||scores on a scale||Standard Deviation|Mean
2739028|NCT00957671|Secondary|Neuropsychological Function as Measured by Digit Span Total at Baseline|"Digit Span; Wechsler Memory Scale III (WMS III).~Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome."|baseline||||scores on a scale||Standard Deviation|Mean
2739029|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|one year||||scores on a scale||Standard Deviation|Mean
2739091|NCT00957359|Secondary|QoL Environment Scale|4-20 (higher score improved quality of life domain)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2739092|NCT00957359|Secondary|QoL Environment Scale|4-20 (higher score improved quality of life domain)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2739030|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
2739031|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|one year||||scores on a scale||Standard Deviation|Mean
2739032|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
2739033|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|One year||||scores on a scale||Standard Deviation|Mean
2739034|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
2739035|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|One year||||scores on a scale||Standard Deviation|Mean
2739036|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
2739037|NCT00957671|Primary|Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.|Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.|one year||||mL/beat||Standard Deviation|Mean
2739038|NCT00957671|Primary|Oxygen Pulse at Baseline.|Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.|baseline||||mL/beat||Standard Deviation|Mean
2739039|NCT00957671|Primary|Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.|Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|one year||||ratio of CO2/O2||Standard Deviation|Mean
2739040|NCT00957671|Primary|Respiratory Exchange Ratio at Baseline.|Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|baseline||||ratio of CO2/O2||Standard Deviation|Mean
2739041|NCT00957671|Primary|Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.|Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|one year||||L/minute||Standard Deviation|Mean
2739042|NCT00957671|Primary|Minute Ventilation at Baseline.|Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|baseline||||L/minute||Standard Deviation|Mean
2739043|NCT00957671|Primary|Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.|Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|one year||||mL/kg/min||Standard Deviation|Mean
2739044|NCT00957671|Primary|Maximum Oxygen Uptake at Baseline.|Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|baseline||||mL/kg/min||Standard Deviation|Mean
2739093|NCT00957359|Secondary|QoL Social Relationships Scale|4-20 (higher score improved quality of life domain)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2739045|NCT00957658|Secondary|Wrist DXA Scan Analysis|DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.|5 years|Participants with available data: 107 hips had DXA scan T-scores at 5 years.|||T-score|hips|Standard Deviation|Mean
2739046|NCT00957658|Secondary|Acetabular Insert Wear|The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.|5 years|Participants with available data: 97 hips were evaluated for wear rate at 5 years.|||millimeters per year|hips|Standard Deviation|Mean
2739047|NCT00957658|Secondary|PEQ (Patient Evaluation Questionnaire) Percent Achievement|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.~EXPECTATIONS KEY:~Participate in recreational activities (dancing,traveling,gardening)~Exercise or participate in sports~Independently perform household chores/daily routine~Easily change position,sit to stand/stand to sit~Remove need for cane crutch or walker~Use stairs normally step by step~Ability to sleep through night~Maintain social activites,caring for someone,playing with children~Use public transportation or drive~Maintain psychological well-being~Maintain sexual activity~Maintain employment"|6 months, 1 year, 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs.|||percentage of participants|hips||Number
2739048|NCT00957658|Secondary|PEQ (Patient Expectation Questionnaire) Overall Satisfaction|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.~EXPECTATIONS KEY:~Participate in recreational activities (dancing,traveling,gardening)~Exercise or participate in sports~Independently perform household chores/daily routine~Easily change position,sit to stand/stand to sit~Remove need for cane crutch or walker~Use stairs normally step by step~Ability to sleep through night~Maintain social activites,caring for someone,playing with children~Use public transportation or drive~Maintain psychological well-being~Maintain sexual activity~Maintain employment"|6 months, 1 year and 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals.|||percentage of particpants|hips||Number
2739049|NCT00957658|Secondary|Change in Lower Extremity Activity Scale (LEAS) Score|The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.|Preoperative, 2 and 5 years|Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score.|||units on a scale|hips|Standard Deviation|Mean
2739050|NCT00957658|Secondary|Change in SF-12 Score|The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Preoperative, 2 and 5 years|Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores.|||units on a scale|hips|Standard Deviation|Mean
2739051|NCT00957658|Secondary|Change in Harris Hip Score (HHS)|The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.|Preoperative, 2 and 5 years|Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score.|||units on a scale|hips|Standard Deviation|Mean
2739052|NCT00957658|Secondary|Revision/Removal Rates|The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.|2 and 5 years|Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants.|||percentage of hips/any component revised|hip||Number
2739053|NCT00957658|Secondary|Percentage (%) of Hip Stems With Aseptic Loosening|Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.|5 years|Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years.|||percentage of hips|hips||Number
2739054|NCT00957658|Primary|Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain||2 years||||percentage of hips|hips||Number
2739055|NCT00957593|Secondary|Perinatal Outcomes|Perinatal outcomes for patients included in the randomized trial|24-72 hours|Routine use of oxytocin vs discontinuation of oxytocin once in active labor 127 ROUTINE 125 discontinuation|||Participants|||Count of Participants
2739056|NCT00957593|Primary|Cesarean Delivery|Mode of delivery is the primary outcome|24-72 hours from admission for induction||||Cesarean deliveries|||Number
2739094|NCT00957359|Secondary|QoL Social Relationships Scale|4-20 (higher score improved quality of life domain)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2739057|NCT00957580|Secondary|Part 2: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Up to 3 years|This outcome measure was not analyzed as the trial was terminated during safety run-in (Part 1).||||||
2739058|NCT00957580|Secondary|Part 1: Percentage of Subjects With Best Overall Response|The best overall response was reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) >1.0x10^9 per liter (/L), platelets >100x10^9 /L, bone marrow aspirate with less than or equal to (<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC >1.0x10^9/L, platelets >100x10^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (<) 5%. (4) Progressive disease (PD) = >50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = Subjects who failed to achieve CR, CRi or PR and without criteria for PD.|Day 29 of every alternate 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012|The efficacy analysis set included all subjects who received at least 1 administration of planned dose of pimasertib and had at least 1 efficacy assessment after the first dose. 'N’ (number of subjects analyzed)=subjects evaluable for this outcome measure.|||Percentage of Subjects|||Number
2739059|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2739060|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib for Pimasertib 75 mg Reporting Arm:Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure and n = subjects evaluable for the specified regimen."|||liter||Standard Deviation|Mean
2739061|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib:Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2739062|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Multiple Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2739063|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib for Pimasertib 75 mg Reporting Arm: Single Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure and n = subjects evaluable for the specified regimen."|||liter/hour||Standard Deviation|Mean
2739064|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Single Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2739095|NCT00957359|Secondary|QoL Social Relationships Scale|4-20 (higher score improved quality of life domain)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2739096|NCT00957359|Secondary|QoL Psychological Scale|4-20 (higher score improved quality of life domain)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2739097|NCT00957359|Secondary|QoL Psychological Scale|4-20 (higher score improved quality of life domain)|2 weeks post drug administration 1||||score on a scale||Standard Error|Mean
2739065|NCT00957580|Secondary|Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Multiple Dose|The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2739066|NCT00957580|Secondary|Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Single Dose|The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2739067|NCT00957580|Secondary|Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘n =Subjects evaluable for this outcome measure for specified categories for each reporting group, respectively."|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2739068|NCT00957580|Secondary|Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2739069|NCT00957580|Secondary|Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Multiple Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
2739070|NCT00957580|Secondary|Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
2739071|NCT00957580|Secondary|Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. Number of subjects analysed refer to the subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
2739072|NCT00957580|Secondary|Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
2739073|NCT00957580|Secondary|Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2739074|NCT00957580|Secondary|Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2739075|NCT00957580|Secondary|Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs include both SAEs and non-SAEs.|Baseline up to 3 years|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Subjects|||Number
2739098|NCT00957359|Secondary|QoL Psychological Scale|4-20 (higher score improved quality of life domain)|2-4 weeks prior to drug administration/ Baseline||||score on a scale||Standard Error|Mean
2739099|NCT00957359|Secondary|QoL Physical Health Scale|4-20 (higher score improved quality of life domain)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2739076|NCT00957580|Primary|Part 2: Percentage of Subjects With Best Overall Response|The best overall response was to be reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) >1.0x10^9 per liter (/L), platelets >100x10^9 /L, bone marrow aspirate with less than or equal to (<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC >1.0x10^9/L, platelets >100x10^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (<) 5%. (4) Progressive disease (PD) = >50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = subjects who failed to achieve CR, CRi or PR and without criteria for PD.|Day 29 of every 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012|Due to limited anti-leukemic effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed. Effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed.||||||
2739077|NCT00957580|Primary|Part 1: Number of Subjects With Dose Limiting Toxicities (DLTs)|The DLT was any toxicity that resulted in treatment delay for more than (>) 2 weeks due to treatment-related adverse effects, or any Grade greater than or equal to (>=) 3 non-hematological toxicity excluding Grade 4 asymptomatic increases in liver function tests reversible within 7 days in subjects with liver involvement, and Grade 3 asymptomatic increases in liver function tests reversible within 7 days for subjects without liver involvement, Grade 3 vomiting unless encountered and persistent for more than 3 days despite adequate and optimal therapy, and Grade 3 diarrhea unless encountered and persistent for more than 3 days despite adequate and optimal anti-diarrhea therapy at any DL and judged to be possibly or probably related to the trial treatment by the Investigator and/or the Sponsor.|Baseline Up to Day 29 of Cycle 1|The DLT analysis set included all subjects who received over 90 percent (%) administration of trial medication in Cycle 1 or showed a DLT.|||subjects|||Number
2739078|NCT00957528|Secondary|9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines|Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months|5 months|All subjects who completed the protocol.|||pg/mL||Standard Deviation|Mean
2739079|NCT00957528|Secondary|Changes in Serum Markers of Bone Turnover.|"Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include:~Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium"|5 months||||nM BCE (Bone Collagen Equivalents)||Standard Error|Mean
2739080|NCT00957528|Secondary|Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months|5 months||||gm/cm^2||Standard Error|Mean
2739081|NCT00957528|Primary|Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Lean body mass is expressed in grams as calculated by Hologic DEXA.|5 months|All subjects who successfully completed the five month protocol.|||grams||Standard Deviation|Mean
2739082|NCT00957528|Primary|Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months|Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).|5 months||||pounds||Standard Deviation|Mean
2739083|NCT00957528|Primary|Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months|The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 − EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool.|5 Months|Subjects who completed the entire treatment protocol|||Percent per hour (%/hr)||Standard Deviation|Mean
2739084|NCT00957424|Primary|Number of Participants Willing to Continue With Preferred HRP||1 week follow up|Those who completed one-week multiple product sampling|||participants|||Number
2739085|NCT00957424|Primary|Number of Participants That Completed 1-week Trial||One week||||participants|||Number
2739086|NCT00957424|Primary|Number of Participants Willing to Try HRPs||Baseline||||participants|||Number
2739087|NCT00957424|Primary|Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)||Baseline||||participants|||Number
2739088|NCT00957372|Primary|PART II: Nº of Treatment-Emergent Adverse Events (TEAE)|The primary objective for Part II of the study was to evaluate the safety and tolerability of eslicarbazepine acetate (ESL, BIA 2-093) at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. Safety assessments were based primarily on AEs (Number of participants with at least one treatment-emergent adverse events are reported); assessment of AEs was based on treatment relatedness, action taken on study drug, outcome, and causality.|1-year|There was no sample size estimate for Part II. Part II was a 1-year open-label extension for patients who had completed Part I and was willing to continue treatment in Part II.|||participants|||Number
2739089|NCT00957372|Primary|Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on results for the ITT population during the 12-week maintenance period. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA model with treatment as a factor and seizure frequency as a covariate|12 weeks|The primary efficacy analysis was based on the ITT population.The intent-to-treat (ITT) population included all randomized patients with at least one dose of investigational product and at least one post-baseline seizure frequency assessment|||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
2739090|NCT00957359|Secondary|QoL Environment Scale|4-20 (higher score improved quality of life domain)|26 weeks post drug administration 2||||score on a scale||Standard Error|Mean
2739146|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||pmol/L||Standard Deviation|Mean
2739147|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||hr||Full Range|Median
2739148|NCT00957268|Secondary|Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||pmol/L||Standard Deviation|Mean
2739149|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||pmol•hr/L||Standard Deviation|Mean
2739150|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||Percentage inhibition||Standard Deviation|Mean
2739151|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||hr||Full Range|Median
2739152|NCT00957268|Secondary|Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||Percentage inhibition||Standard Deviation|Mean
2739153|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||Percentage inhibition•hr||Standard Deviation|Mean
2739154|NCT00957268|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.|||ng•hr/mL||Standard Deviation|Mean
2739155|NCT00957268|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.|||hr||Standard Deviation|Mean
2739156|NCT00957268|Primary|Cmax: Maximum Observed Plasma Concentration for Alogliptin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.|||ng/mL||Standard Deviation|Mean
2739157|NCT00957242|Secondary|Fibrin D-dimer Change From Baseline to 16 Weeks|Biomarker that measures biologic activities in patients as opposed to response.|maximum of 48 weeks||||mg/ml||Standard Deviation|Mean
2739158|NCT00957242|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks|The DLCO measures the partial pressure difference between inspired and expired carbon monoxide.|Week 48 / Final Visit||||mL/min/mmHg||Standard Deviation|Mean
2739159|NCT00957242|Secondary|Total Score St. George's Respiratory Questionnaire (SGRQ)|The SGRQ is a quality of life measurement used to assess respiratory well being with a 0*-100 range (*indicates better health--lower is better).|Week 16 Change from Baseline|All participants per intention-to-treat|||score on a scale||Standard Deviation|Mean
2739160|NCT00957242|Secondary|Change in 6-minute Walk Distance (6MWD)|The 6MWD is a measure of exercise tolerance. Change in exercise tolerance is calculated at the latest time point (up to 48 weeks) minus the earliest time point (at baseline).|Change from baseline to last visit (maximum of 48 weeks)||||meters||Standard Deviation|Mean
2739161|NCT00957242|Secondary|Cardiovascular Mortality or Morbidity|Measured at 48 Weeks|maximum of 48 weeks||||events|||Number
2739162|NCT00957242|Secondary|Respiratory-related Hospitalizations||maximum 48 weeks||||events|||Number
2739163|NCT00957242|Secondary|Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)||maximum of 48 weeks||||events|||Number
2739164|NCT00957242|Secondary|Bleeding Events||maximum of 48 weeks||||events|||Number
2739165|NCT00957242|Secondary|All-cause Hospitalizations||maximum 48 weeks||||events|||Number
2739166|NCT00957242|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks|Week-16 change from Baseline|16 weeks||||liters||Standard Deviation|Mean
2739167|NCT00957242|Secondary|All Cause Mortality||maximum of 48 weeks|All participants per intention-to-treat (ITT)|||events|||Number
2739168|NCT00957242|Primary|Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity|Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity.|Events up to 48 weeks|All participants per intention-to-treat (ITT)|||events|||Number
2739169|NCT00957047|Primary|PART II - Nº of Treatment-Emergent Adverse Events (TEAE)|Safety assessments were based primarily on AEs (Number of patients who experienced at least one AEs), and on whether these were related to the study medication, were serious, led to permanent discontinuation of study participation, or led to death.|1 year||||participants|||Number
2739170|NCT00957047|Primary|PART I - Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the ITT population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.|12-week maintenance period|The primary efficacy analysis was an ANCOVA that assessed reduction in seizure frequency per 4 weeks for the ITT population during the 12-week maintenance period|||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
2739171|NCT00957034|Secondary|Percent Change Physician Global Assessment of Heart Failure Status|Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
2739172|NCT00957034|Secondary|Percent Change Patient Global Assessment of Heart Failure Status|Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
2739173|NCT00957034|Secondary|Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores|Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social & economic impairments included as part of overall score.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
2739174|NCT00957034|Secondary|Mortality or Hospitalizations|Composite endpoint - patients who were hospitalized or died during the trial.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Participants|||Number
2739175|NCT00957034|Secondary|Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification|Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change|||Number
2739176|NCT00957034|Primary|Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters|Measurement of distance walked as fast as possible on a hard flat pathway in six minutes|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
2744167|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
2739177|NCT00957021|Secondary|Radiographic Outcome|Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.|1,2 and 5 years|Maximum number of knees evaluable at any interval.|||knees|knees||Number
2739178|NCT00957021|Secondary|Patient Outcome Lower-Extremity Activity Scale|The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.|1,2,3,4 and 5 years|Maximum number of knees available at any interval.|||units on a scale|knees|Standard Deviation|Mean
2739179|NCT00957021|Secondary|Patient Outcome WOMAC|"The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.~Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison."|5 years|The number of knees evaluated at 5 years.|||units on a scale|knees|Standard Deviation|Mean
2739180|NCT00957021|Secondary|Patient Outcome SF-36|The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.|1,2,3,4 and 5 years|Maximum number of knees evaluated at any interval.|||units on a scale|knees|Standard Deviation|Mean
2739181|NCT00957021|Secondary|Patient Outcome Knee Society Score|"The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|1,2 and 5 years|Maximum number of knees evaluated at any interval.|||units on a scale|knees|Standard Deviation|Mean
2739182|NCT00957021|Primary|Range of Motion|The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.|2 years|Participants can have both knees replaced. Range of motion is measured for each knee, as such the number of knees evaluated can be greater than the number of participants.|||degrees|Knees|Standard Deviation|Mean
2739183|NCT00957008|Secondary|Blood Fasting Glucose||Month 9|Last observation carried forward|||mg/dl||95% Confidence Interval|Least Squares Mean
2739184|NCT00957008|Primary|Waist Circumference||4 month||||cm||Standard Error|Least Squares Mean
2739185|NCT00957008|Primary|Body Weight||4 month||||kg||Standard Error|Least Squares Mean
2739186|NCT00957008|Primary|Body Weight|Body weight was assessed using a calibrated balance-beam scale.|nine month||||Kg||Standard Error|Least Squares Mean
2739187|NCT00957008|Primary|Waist Circumference|Waist circumference was measured at the level of the umbilicus with a plastic tape measure.|Month 9||||cm||Standard Error|Least Squares Mean
2739188|NCT00956943|Secondary|Side Effects|frequency of serious adverse events|8 weeks|intent to treat|||events|||Number
2739189|NCT00956943|Primary|Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment|quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)|After 8 weeks of treatment with the patch, outcome will be measured.|intent to treat|||participants|||Number
2739190|NCT00956930|Secondary|Overall Survival|Comparing overall survival of both treatment arms.|From day of randomization until date of death, or liver transplant or 7/15/2016, whichever came first, assessed up to 6 years||||Months||95% Confidence Interval|Median
2739191|NCT00956930|Secondary|Number of Patients Who Achieved Complete or Partial Radiologic Response After Treatment|"Repeat imaging (CT/MRI) and lab work including tumor markers will be assessed 1 month post-treatment then every 3 months after that. Both EASL & WHO criteria are used.~By EASL criteria Complete response is 100% Decrease in amount of enhancing tissue in index lesion, Partial response is ≥50% deecrease in amount of enhancing tissue in index lesion, Stable disease is <50% Decrease in to ≤ 25% increase in amount of enhancing tissue in index lesion, Progressive disease <25% Increase in amount of enhancing tissue in index lesion and/or new enhancement in previously treated index lesion."|up to 6 years||||Participants|||Count of Participants
2739192|NCT00956930|Primary|Time to Progression (TTP) in Patients Treated With TACE and Y90|"Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. Patients have repeat imaging done (MRI or CT) at 1-month post procedure and then every 3 months after that. TTP and overall survival (OS) analyses were calculated from day of randomization by Kaplan-Meier analysis on intention-to-treat (ITT) basis.~Progression (which is detected on follow-up imaging scans) was defined as:~Progression by World Health Organization (WHO) response criteria 25% increase in bidimensional cross product.~Progression by European Assosciation for the Study of the Liver (EASL): 25% increase in arterial enhancement~Malignant portal vein tumor thrombus development~Index lesion: lesions requiring re-treatment because of worsening circumferential enhancement~Development of new lesions or extra-hepatic metastases."|Up to 6 yrs||||Months||95% Confidence Interval|Median
2739193|NCT00956839|Secondary|Serum Total Calcium|Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months|0, 1, 3, 6 months post intervention|at time points 0, 1, 3 and 6 months|||mg/dL||Standard Deviation|Mean
2739195|NCT00956813|Secondary|Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data. On a 0-10 scale, patients were asked to describe how hot flashes interfered with 10 different aspects of their life (work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life). Scores were converted to a 0-100 scale where 100 is best QOL.The HFRDIS total score was the average of the 10 individual questions. The change in total score from baseline to end of treatment was analyzed between the groups using a Kruskal-Wallace test.|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
2739196|NCT00956813|Secondary|Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)|The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a 0-6 scale, patients were asked to answer questions in in each of 4 domain scores (Vasomotor, Psychosocial, Physical, Sexual) Scores were converted to a 0-100 scale where 100 is best QOL. The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category.|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
2739197|NCT00956813|Secondary|Change of Mood as Measured by the Profile of Mood States (POMS)|"Profile of Mood States (POMS) was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are scored from 0 (not at all) to 4 (extremely). Individual scores were converted to a 0-100 scale where 100 is best quality of life.~The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo arms was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported."|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
2739198|NCT00956813|Secondary|Toxicity as Measured by CTCAE v3.0|Frequency and severity of adverse events were reported by patients weekly evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 7 weeks|All patients treated during the Double-blinded period of the study were included in this analysis|||Participants|||Count of Participants
2739199|NCT00956813|Primary|To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.|"The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.~The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7.~The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms."|Baseline and 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
2739200|NCT00956761|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0-3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.|||Number of participants|||Number
2739201|NCT00956761|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
2739202|NCT00956761|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
2739252|NCT00955968|Secondary|Medication Adherence - How Closely Followed Schedule|Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.|week 0, 48 and 96|Participants in the Continue HAART arm who had evaluations done at the respective weeks|||Participants|||Count of Participants
2739203|NCT00956761|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2739204|NCT00956709|Secondary|Duration of Sensory Sciatic Block (h)||72 hours||||hours||Full Range|Median
2739205|NCT00956709|Secondary|Duration of Motor Sciatic Block (h)||72 hours||||hours||Full Range|Median
2739206|NCT00956709|Secondary|Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.||72 hours|||||||
2739207|NCT00956709|Primary|Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot||72 hours|Two patients in each group had incomplete block before surgery.|||minutes||Full Range|Median
2739208|NCT00956657|Primary|CR Adherence|Number of cardiac rehabilitation classes attended in total.|Approximately 3-months after recruitment||||Classes Attended||Standard Deviation|Mean
2739209|NCT00956657|Secondary|Illness Perceptions Questionnaire-Revised Scores|Eight sub-scale scores obtained. Sub-scales include; Illness consequences, Illness Control, Treatment Control, Illness Identity, Emotional Representation, Illness Cause, Illness Coherence, Timeline Cyclical. Minimum and Maximum scores vary for each sub-scale.|3-months after consent|||||||
2739210|NCT00956631|Other Pre-specified|Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.|Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.|Baseline and Six Months|All available participants were analyzed at six months.|||units on a scale||95% Confidence Interval|Mean
2739211|NCT00956631|Other Pre-specified|Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.|Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).|Baseline and Six months|All available participants at Month 6.|||units on a scale||95% Confidence Interval|Mean
2739212|NCT00956631|Primary|Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at Month 6.|||units on a scale||95% Confidence Interval|Mean
2739213|NCT00956592|Secondary|Number of Particpants Requiring Adjuncts to Assist Intubation||1 year|Use of bougie or external manipulation|||Participants|||Count of Participants
2739214|NCT00956592|Secondary|Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.|Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved|1 year||||Participants|||Count of Participants
2739215|NCT00956592|Secondary|Number of Participants With Complications||1 year||||Participants|||Count of Participants
2739216|NCT00956592|Secondary|Number of Participants Intubated With a Rescue Device||1 year||||participants|||Number
2739217|NCT00956592|Secondary|Intubation Time|Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation|During laryngoscopy procedure|time|||seconds||90% Confidence Interval|Mean
2739218|NCT00956592|Primary|Measure of Intubation Success|Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure|During each intubation in a 14 month period|4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study|||Participants||95% Confidence Interval|Number
2739219|NCT00956540|Primary|Weaning Time|The weaning time starts at the first disconnection from mechanical ventilation lasting >30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.|6 months||||day||Standard Deviation|Mean
2739220|NCT00956540|Secondary|Tracheobronchitis and Pneumonia||6 months|||||||
2744168|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
2739221|NCT00956293|Secondary|Renal Function by Proteinuria||Months12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739222|NCT00956293|Secondary|Renal Function by GFR Over Time||Months 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739223|NCT00956293|Secondary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.|Months 6, 12, 24, 36, 48 and 60|Randomized Safety Set: This set included all randomized participants who received at least one dose of study medication.|||Participants|||Number
2739224|NCT00956293|Secondary|CD25 Saturation on Lymphocytes||Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739225|NCT00956293|Secondary|Evolution of Renal Function (Creatinine Slope)|The study was terminated prematurely and not powered for efficacy.|Week 7, Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739226|NCT00956293|Secondary|Occurrence of Treatment Failures|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739227|NCT00956293|Secondary|Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739228|NCT00956293|Secondary|Renal Function by Serum Creatinine|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739229|NCT00956293|Secondary|Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739230|NCT00956293|Primary|Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2739231|NCT00956254|Secondary|AUC0-last of Fentanyl|AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic evaluable population: All subjects who had evaluable plasma profiles to calculate reliable estimates of pharmacokinetic parameters and who had no major protocol deviations.|||hr*ng/mL||Standard Deviation|Mean
2739232|NCT00956254|Secondary|Tmax of Fentanyl|Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.|||hr||Standard Deviation|Mean
2739233|NCT00956254|Primary|Cmax of Fentanyl|Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.|||ng/mL||Standard Deviation|Mean
2739253|NCT00955968|Secondary|Medication Adherence - Last Time Missed Medications|Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.|week 0, 48 and 96|Participants in the Continue HAART arm who had evaluations done at the respective weeks|||Participants|||Count of Participants
2739234|NCT00956085|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 6 weeks||||Participants|||Count of Participants
2739235|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
2739236|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
2739237|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
2739238|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
2739239|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.|||% spec.with>5 immature capillaries/HPF|||Number
2739240|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.|||% spec.with>5 immature capillaries/HPF|Participants||Number
2739241|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment.|||%specimen with >25%new collagen/HPF|||Number
2739254|NCT00955968|Secondary|Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm|VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2)|At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.|156 women who were VFs had antiretroviral drug resistance testing performed.|||Participants|||Count of Participants
2739242|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment.|||%specimen with >25%new collagen/HPF|||Number
2739243|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
2739244|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
2739245|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
2739246|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
2739247|NCT00955968|Secondary|Cost Effectiveness and Feasibility of Treatment Models|This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.|Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.||||||
2739248|NCT00955968|Secondary|Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.|Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.||||||
2739249|NCT00955968|Secondary|Quality of Life|The quality of life objective was not included in the primary analysis of the study but intended as a separate subsequent analysis, conditional on funding. The specific outcome measure(s) will be defined in more detail in a separate analysis plan developed closer to the analysis. Upon completion of the analysis, the results will be reported to CT.gov.|Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).||2020-07-31|07/2020||||
2739250|NCT00955968|Secondary|Medication Adherence - Missed Dose Within Past 4 Days|Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.|week 0, 48 and 96|Participants in the Continue HAART arm who had evaluations done at the respective weeks|||Participants|||Count of Participants
2739251|NCT00955968|Secondary|Medication Adherence - How Often Follow Instructions|Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.|week 0, 48 and 96|Participants in the Continue HAART arm who had evaluations done at the respective weeks|||Participants|||Count of Participants
2739255|NCT00955968|Secondary|Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.||||||
2739256|NCT00955968|Secondary|Incidence Rate of Other Targeted Medical Conditions|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.||||||
2739257|NCT00955968|Secondary|Incidence Rate of Cardiovascular or Other Metabolic Events|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.||||||
2739258|NCT00955968|Secondary|Incidence Rate of Grade 2 and Above Toxicity|The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method.|All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739259|NCT00955968|Secondary|Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events|HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739260|NCT00955968|Secondary|Incidence Rate of HIV/AIDS Related Events or Death|HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739261|NCT00955968|Secondary|Incidence Rate of HIV/AIDS Related Events|HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739262|NCT00955968|Secondary|Incidence Rate of Deaths|The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739263|NCT00955968|Secondary|Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event|Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739264|NCT00955968|Secondary|Incidence Rate of AIDS - Defining Illness|AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739283|NCT00955877|Primary|Quantity of Fentanyl Administered|Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.|48 hour post-operative period||||mcg||Standard Deviation|Mean
2739361|NCT00955487|Primary|Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight|Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)|Randomization to discharge||||Participants|||Count of Participants
2739265|NCT00955968|Primary|Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death|AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
2739266|NCT00955955|Secondary|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|"This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure:~Enter the highest score from questions 1-4 (sleep items): ______~Enter score on item 5 ____~Enter the highest score from questions 6-9 (appetite/weight): ______~Enter score on item 10 ____~Enter score on item 11 ____~Enter score on item 12 ____~Enter score on item 13 ____~Enter score on item 14 ____~Enter the highest score from questions 15-16 (psychomotor items): ______~Total score range 0-27: ______~When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning."|Baseline and Day 60|Data presented is mean score reduction for the QIDS. The dataset of interest is limited to patients treated with placebo in phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone.|||Scores on a scale||Standard Deviation|Mean
2739267|NCT00955955|Primary|The 17-item Hamilton Depression Scale (HAM-D-17)|"The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68.~When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased)."|Baseline and Day 60|The phase II dataset of interest is limited to patients treated with placebo in phase I, completed phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone. Some patients received Deplin in both phases of the study, but those patients are not included in these analyses.|||Scores on a scale||Standard Deviation|Mean
2739268|NCT00955916|Secondary|Median Overall Survival (OS)|Overall Survival is defined as the time from randomization until death from any cause.|Up to 3 years|All participants|||months||95% Confidence Interval|Median
2739269|NCT00955916|Secondary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the duration of time from start of treatment to time of progression. Leukemia related failure (progressive disease): Failure to induce bone marrow hypoplasia after 2 cycles or regrowth of leukemic blasts ≥ 20%.|Up to 3 years|All participants|||months||95% Confidence Interval|Median
2739270|NCT00955916|Primary|Overall Response Rate (ORR)|Overall Response Rate: Morphologic Complete Remission (CR) + Morphologic Complete Remission with incomplete blood count recovery (CRi) for evaluable participants. CR - Bone Marrow: < 5% blasts without Auer rods with at least 20% cellularity with maturation of all cell lines, No presence of unique phenotype by flow cytometry identical to what was found in the pretreatment specimen, No persistent dysplasia; Peripheral: normal blood counts, absolute neutrophil count (ANC) > 1.0 k/μl and platelets > 100 k/μl ANC > 1.0 k/μl and platelets > 100 k/μl (Peripheral blood counts documenting recovery can be utilized within 4 weeks of the bone marrow); No evidence of extramedullary leukemia. CRi - All CR criteria are met except for residual Neutropenia <1.0 x 10^9/L platelets < 100 k/μl.|8 weeks per participant|All participants|||percentage of participants|||Number
2739271|NCT00955903|Secondary|Weight Change/Maintenance|The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year||||Kg||Standard Deviation|Mean
2739272|NCT00955903|Secondary|Cardiometabolic Risk Factors|We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year||||mg/dL||Standard Deviation|Mean
2739273|NCT00955903|Primary|Change in Abdominal Fat Mass|Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year||||Cubic cm||Standard Deviation|Mean
2739274|NCT00955877|Secondary|Number of Participants That Were Bradycardia Within 48hr Post Surgery|Number of participants that were bradycardia within 48hr post surgery|48hr post surgery||||Participants|||Count of Participants
2739275|NCT00955877|Secondary|Number of Participants That Were Given Zofran 48hr Post Surgery|Number of participants that were given Zofran 48hr post surgery|48hr post surgery||||Participants|||Count of Participants
2739276|NCT00955877|Secondary|Number of Participants That Were Given Codeine 48hr Post Surgery|Number of participants that were given codeine 48hr post surgery|48hr post surgery||||Participants|||Count of Participants
2739277|NCT00955877|Secondary|Number of Participants With Pruritis Within 48hrs Post op|Number of participants with pruritis within 48hrs post operation|48 hour post-operative period||||Participants|||Count of Participants
2739278|NCT00955877|Secondary|Number of Participants With Nausea and/or Vomiting 48hrs Post op.|Number of participants with nausea and or vomiting 48hr post surgery|48 hour post-operative period||||Participants|||Count of Participants
2739279|NCT00955877|Secondary|Number of Participants That Had Urine Retention for 48hrs Post Foley Catheter Removal.|Number of participants that had urine retention for 48hrs post foley catheter removal.|After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period||||Participants|||Count of Participants
2739280|NCT00955877|Secondary|Number of Participants With CSF Leaks Within 6 Months Post op.|Number of participants with CSF leaks within 6 months post operation.|6 month post-operative period||||Participants|||Count of Participants
2739281|NCT00955877|Secondary|Number of Participants With Hemodynamic Instability 48hrs Post op|Number of Participants with Hemodynamic Instability 48hrs post operation|48 hour post-operative period||||Participants|||Count of Participants
2739282|NCT00955877|Secondary|Number of Participants With Respiratory Depression Within 48hrs Post op|Number of participants with respiratory depression within 48hrs post operation|48 hour post-operative period||||Participants|||Count of Participants
2739284|NCT00955877|Primary|Adequacy of Analgesia as Judged by Age-adjusted Pain Scales|"Mean and standard deviation for standardized, age-appropriate pain scales (per patient per day) 48hrs post surgery. As is standard of care at St. Louis Children's Hospital, pain level was scored based on age using the Face, Legs, Activity, Cry, Consolability (FLACC) for participants aged 0-3, the FACES scale on participants between the age of 3 and 5, numeric pain rating scale (NRS) on participants between the age of 5 and 8 years, or the Individualized Numeric Rating Scale (INRS) for participants greater than or equal to 8 years of age. All four of the scales were ranged from 0-10 scores, with 0 being no pain at all, and 10 being extreme pain. Each patient had two scores given, one at 24hrs and one at 48hrs post surgery. The output was reported as an average of all scores for all patients within each group."|48 hour post-operative period||||units on a scale||Standard Deviation|Mean
2739285|NCT00955825|Primary|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.~The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).~The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 42.8 days)|The Full Analysis Set (FAS) includes all patients who received at least one dose of the investigational product and had at least one Combined Score while on treatment during the pollen period. The FAS was regarded as primary for the efficacy evaluations.|||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
2739286|NCT00955747|Primary|Change in Hemoglobin A1C Level From Baseline|The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.|1 year from baseline|Calculation of the final numbers for study completion considers a standard deviation of 1.4%, a two-sided 95% confidence interval (alpha= 0.025), power of 90%, and the ability to detect a 0.5% difference in HbA1c between treatment and placebo groups.|||percentage of change from baseline||Standard Error|Least Squares Mean
2739287|NCT00955721|Secondary|Phase II: Explore Biomarkers of Response to the Combination|A study of the correlation between biomarker levels and response to RPTD study therapy. Blood samples for biomarker analysis are collected at baseline and on day 1 of Cycles 2 onward|Baseline, Day 1 of Cycle 2 and subsequent cycles, about 9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
2739288|NCT00955721|Secondary|Phase II: Further Evaluate the Safety of the Proposed Combination|Rate of study participants experiencing toxicity after receiving study therapy at the recommended Phase 2 Dose (RPTD).|About 9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
2739289|NCT00955721|Secondary|Phase II: Estimate Overall Survival|Overall survival is defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.|Start of treatment until death or date of last contact|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
2739290|NCT00955721|Secondary|Phase II: Estimate Overall Response Rate and Clinical Benefit Rate.|Overall response rate [CR + PR]. Clinical Benefit Rate [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|About 9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
2739291|NCT00955721|Primary|Phase II: Obtain an Estimate of the 9-month Progression-free Survival Rate in Patients With Advanced BTC Receiving the RPTD of the Combination Sorafenib and GEMOX.|Rate of study participants achieving progression-free survival at 9 months post-initiation of study therapy at RPTD. Progression-Free Survival (PFS) is defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.|9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the determination of the RPTD and the opening of Phase 2.||||||
2739292|NCT00955721|Primary|Phase I: Recommended Phase II Dose (RPTD) of the Combination of Sorafenib and GEMOX in Patients With Advanced Biliary Tract Cancer (BTC).|Establish the recommended phase II dose (RPTD) of the combination of sorafenib and GEMOX in patients with advanced biliary tract cancer (BTC).|First two 14-day Phase I cycles|A total of 9 participants were enrolled in Phase 1 of which 6 were evaluable and analyzed for this outcome measure. A recommended phase two dose (RPTD) of the combination of Sorafenib and GEMOX therapy could not be determined because dose escalation was still in progress when the study was terminated.|||mg|||Number
2739293|NCT00955708|Primary|Chronic Left Ventricular Lead-related Complication Free Rate||Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).||||Percent free from event||95% Confidence Interval|Number
2739294|NCT00955682|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|At 12 months (Month 60) post booster dose|The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point.|||Participants|||Count of Participants
2739295|NCT00955682|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|At one month (Month 49) post booster dose.|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented.|||Participants|||Count of Participants
2739296|NCT00955682|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|At Month 48|The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point.|||Participants|||Count of Participants
2739297|NCT00955682|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|At Month 36|The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point.|||Participants|||Count of Participants
2739298|NCT00955682|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|At Month 24 post primary dose|The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) [NCT00474266], who came back to the visit at the considered time point.|||Participants|||Count of Participants
2739299|NCT00955682|Secondary|Number of Subjects Reporting Any Adverse Events (AEs)|Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to vaccination. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.|During the 31-day period (Days 0-30) after booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented, and with their symptom sheet filled-in.|||Participants|||Count of Participants
2739300|NCT00955682|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination|During the 8-day period (Days 0-7) after the booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented, and with the symptom sheet filled-in.|||Participants|||Count of Participants
2739301|NCT00955682|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 8-day period (Days 0-7) after booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) [NCT00474266], with a booster vaccine administration documented and with their symptom sheet filled-in.|||Participants|||Count of Participants
2739302|NCT00955682|Secondary|Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.|At 12 months (Month 60) post booster dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2739303|NCT00955682|Secondary|Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.|At one month (Month 49) post booster dose|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2739304|NCT00955682|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values|The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.|At 12 months (Month 60) post booster dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739305|NCT00955682|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values|The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.|At one month (Month 49) post booster dose|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2739306|NCT00955682|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres|The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.|At 12 months (Month 60) post booster dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739358|NCT00955487|Secondary|Total Ventilation Days|Of those participants who required mechanical ventilation, the total number of days receiving ventilation|After randomization up until hospital discharge||||Days||Standard Deviation|Mean
2766105|NCT00765388|Secondary|Feeling of Security During the Night|The patients feeling of security with the product during the night|4 weeks|ITT population|||Participants|||Number
2739307|NCT00955682|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres|The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.|At one month (Month 49) post booster dose|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Titres||95% Confidence Interval|Geometric Mean
2739308|NCT00955682|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values|The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK.|At 12 months (Month 60) post booster dose.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739309|NCT00955682|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values|The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK.|At one month (Month 49) post booster dose|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2739310|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory.|At 12 months (Month 60) post booster dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739311|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory.|At one month (Month 49) post booster dose|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Titres||95% Confidence Interval|Geometric Mean
2739312|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values|The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.|At 12 months (Month 60) post booster dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739313|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.|At one month (Month 49) post booster dose|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.|||Participants|||Count of Participants
2739314|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory.|At Month 60 pre-primary vaccination and post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739315|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut off values for the assay were ≥ 1:8 and 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.|At Month 60 pre-primary vaccination and post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739316|NCT00955682|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 48 post-primary vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2739317|NCT00955682|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL.|At Month 36 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2739359|NCT00955487|Secondary|Need for Mechanical Ventilation|Number of participants who required endotracheal intubation and mechanical ventilation|Anytime after randomization up to 36 weeks corrected gestational age||||Participants|||Count of Participants
2739318|NCT00955682|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 48 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739319|NCT00955682|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 36 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739320|NCT00955682|Secondary|Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.|At Month 48 post primary dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2739321|NCT00955682|Secondary|Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2739322|NCT00955682|Secondary|Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory.|At Month 24 post primary dose|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||μg/m||95% Confidence Interval|Geometric Mean
2739323|NCT00955682|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by GSK.|At Month 48 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739324|NCT00955682|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by the GSK laboratory.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739325|NCT00955682|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory.|At Month 24 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739326|NCT00955682|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres|The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK.|At Month 48 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739327|NCT00955682|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres|The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739328|NCT00955682|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres|The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.|At Month 24 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739360|NCT00955487|Secondary|Severity of Bronchopulmonary Dysplasia (BPD)|Assessment of the severity of BPD as defined by the oxygen reduction test|36 weeks corrected gestational age||||Participants|||Count of Participants
2739329|NCT00955682|Secondary|Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off|The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory.|At Month 48 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739330|NCT00955682|Secondary|Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off|The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739331|NCT00955682|Secondary|Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off|The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK.|At Month 24 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739332|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 48 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739333|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 36 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739334|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off value for the assay was ≥ 1:128. rSBA-MenA results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 48 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739335|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off for the assay was ≥ 1:128. rSBA-MenA results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 36 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739336|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.|At Month 48 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739337|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739338|NCT00955682|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres|The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory|At Months 24 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Titres||95% Confidence Interval|Geometric Mean
2739339|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.|At Month 48 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739362|NCT00955487|Primary|Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality|Number of participants that developed bronchopulmonary dysplasia and/or that died|Week 36 or earlier, if participants are discharged from the hospital||||Participants|||Count of Participants
2739340|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739341|NCT00955682|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off|The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.|At Month 24 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739342|NCT00955682|Primary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres|The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 48 post-primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739343|NCT00955682|Primary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres|The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).|At Month 36 post-primary vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739344|NCT00955682|Primary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.|At Month 48 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266] , who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739345|NCT00955682|Primary|Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off|The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.|At Month 36 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739346|NCT00955682|Primary|Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off|The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.|At Month 24 post primary vaccination|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) [NCT00474266], who complied with the protocol requirements and who had available assay results for at least one tested antigen.|||Participants|||Count of Participants
2739347|NCT00955617|Secondary|Signal Intensity|Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.|MRA examination||||Ratio||Standard Deviation|Mean
2739348|NCT00955617|Secondary|Diagnostic Confidence|"Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.~Each image is analysed by 4 readers."|MRA examination|Descriptive study - No calculation|||Images|Participants||Number
2739349|NCT00955617|Primary|Overall Image Quality of MRA Images|"Number of images quoted with excellent and more than adequate quality in each group.~Image quality will be assessed on a 5-point scale:~Excellent~More than adequate~Adequate~Less than adequate~Non-diagnostic~Each image is analysed by 4 readers."|MRA examination|descriptive and pilot study, no number of participants calculation performed|||Images|Participants||Number
2739350|NCT00955513|Primary|Measure: Pain on Movement on Day 5 (Change From Baseline).|Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.|baseline and day 5||||mm||Standard Deviation|Mean
2739351|NCT00955487|Other Pre-specified|Days in Hospital|Length of stay of participants|From birth to hospital discharge||||Days||Standard Deviation|Mean
2739352|NCT00955487|Secondary|Sepsis|Number of participants that developed sepsis|Randomization to discharge||||Participants|||Count of Participants
2739353|NCT00955487|Secondary|Severe Intracranial Hemorrhage|Number of participants that developed severe intracranial hemorrhage (grade 3-4)|Randomization to discharge||||Participants|||Count of Participants
2739354|NCT00955487|Secondary|Threshold Retinopathy of Prematurity (ROP)|Threshold ROP defined as requiring interventional therapy|Randomization to discharge||||Participants|||Count of Participants
2739355|NCT00955487|Secondary|Symptomatic PDA Requiring Surgical Ligation|Number of participants with symptomatic PDA that required surgical ligation|Randomization through discharge||||Participants|||Count of Participants
2739356|NCT00955487|Secondary|Symptomatic PDA Requiring Medical Treatment|Number of participants with a symptomatic PDA that required medical treatment|From randomization until discharge||||Participants|||Count of Participants
2739357|NCT00955487|Secondary|Necrotizing Enterocolitis (NEC)|Number of participants diagnosed with necrotizing enterocolitis|After randomization through hospital discharge||||Participants|||Count of Participants
2739363|NCT00955474|Secondary|Blood Hemoglobin A1C at Baseline and Week 8.|Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||% glycated hemoglobin||Standard Deviation|Mean
2739364|NCT00955474|Secondary|LDL Blood Levels at Baseline and Week 8.|LDL levels at Baseline and Week 8. Normal range < 100 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
2739365|NCT00955474|Secondary|HDL Blood Levels at Baseline and Week 8.|HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
2739366|NCT00955474|Secondary|Blood Level of Triglycerides at Baseline and Week 8.|Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
2739367|NCT00955474|Secondary|Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.|Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
2739368|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.|RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739369|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.|RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739370|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.|RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739371|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.|RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739372|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score|RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739373|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score|Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks.|8|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739404|NCT00955201|Other Pre-specified|Weight|Weight of subjects at baseline, 12-weeks, and 24-weeks|Baseline, 12-wks, 24-wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation.|||kg||Standard Deviation|Mean
2739374|NCT00955474|Secondary|CPFQ (Cognitive and Psychological Functioning Questionnaire)|Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739375|NCT00955474|Secondary|Fasting Blood Glucose|Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||ml/dl||Standard Deviation|Mean
2739376|NCT00955474|Primary|Psychosis|Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe.|8 weeks|Complete missing data for 2 subjects in the quetiapine with SSRI group (11 of 13 have baseline outcome measures). There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739377|NCT00955474|Primary|Depression|Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
2739378|NCT00955357|Primary|"The Proportion of Subjects Who Achieved Seizure-free Status During the First 12 Weeks of the Maintenance Phase"|"A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.~This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn."|From Week 7 (end of Week 6) to end of Week 18|The Analysis Population refers to the Completer Set (CS) which includes all subjects who were enrolled, received at least one dose of Lacosamide and completed the first 12 weeks of the Maintenance Phase.|||percentage of subjects|||Number
2739379|NCT00955305|Secondary|Proportion of Patients With Objective Response|"Objective response was evaluated using the RECIST 1.1 criteria.~Objective response includes complete response (CR) and partial response (PR). Objective response is defined as disappearance of all target lesions or at least a 30% decrease in the sum of the diameters of target lesions. In addition, non-target lesions do not meet the criteria for disease progression and no new lesions were observed."|Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years|Eligible and treated patients|||Proportion of participants||95% Confidence Interval|Number
2739380|NCT00955305|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2739381|NCT00955305|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to progression or death without documentation of progression. For cases without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurs within 3 months following the date last known progression-free, in which case the death was counted as a failure.~Progression was evaluated using RECIST 1.1 criteria and defined as:~At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.~OR~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2739382|NCT00955279|Secondary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.|||percent of predicted FVC||Standard Error|Least Squares Mean
2739383|NCT00955279|Secondary|Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale|The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.|Week 28|Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication.|||Percentage of Participants|||Number
2739384|NCT00955279|Secondary|Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2739385|NCT00955279|Secondary|Change From Baseline in 6-minute Walk Distance at Week 28|Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.|||meters||Standard Error|Least Squares Mean
2739405|NCT00955201|Other Pre-specified|Height|Height of subjects upon entry into study|baseline||||cm||Standard Deviation|Mean
2739386|NCT00955279|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value.|Baseline (Day 1) and Week 16|Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication.|||percent of predicted FVC||Standard Error|Least Squares Mean
2739387|NCT00955266|Secondary|Length of ICU Stay (Days)|Intensive Care Unit length of stay in days.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
2739388|NCT00955266|Secondary|Length of Hospital Stay (Days)|Hospital length of stay in days.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
2739389|NCT00955266|Secondary|Need for Inotropic or Vasopressor Support Upon Leaving the OR|Use of inotropes or vasopressors in the Operating Room.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
2739390|NCT00955266|Secondary|Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability|Return to Cardiopulmonary bypass Yes/ No|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
2739391|NCT00955266|Primary|Diastolic Dysfunction|E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
2739392|NCT00955253|Secondary|Performance on Motor Tasks|Time taken to take pegs from a container and place them into holes on a board, and then remove these pegs and replace them in the container.|5 Days|All patients were unable to carry out this task (9 hold PEG test of finger dexterity) because of the paralysis caused by their stroke.||||||
2739393|NCT00955253|Primary|Performance on Tests of Hemispatial Neglect and Sustained Attention|"Touchscreen Cancellation: This is a computerised scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched (Invisible Cancellation).The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance."|5 days|Baseline performance was determined for each patient by averaging scores on days 1, 3 and 5, as well as the preadministration sessions on days 2 and 4. Group averages and differences were computed between treatment type (baseline, guanfacine and placebo) across individuals.|||Number of targets found||Standard Deviation|Mean
2739394|NCT00955201|Other Pre-specified|Age|Age of participants at entry into study.|at baseline||||years||Standard Deviation|Mean
2739395|NCT00955201|Other Pre-specified|Thyroid Stimulating Hormone Laboratory Values|Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study|Baseline||||uIU/mL||Standard Deviation|Mean
2739396|NCT00955201|Other Pre-specified|Aspartate Aminotransferase Laboratory Values|Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study|Baseline||||units/L||Standard Deviation|Mean
2739397|NCT00955201|Other Pre-specified|Blood Urea Nitrogen (BUN) Laboratory Values|Laboratory Blood Urea Nitrogen levels at baseline entry into study|Baseline||||mg/dL||Standard Deviation|Mean
2739398|NCT00955201|Other Pre-specified|Creatinine Laboratory Values|Laboratory creatinine values at baseline entry into study|Baseline||||mg/dL||Standard Deviation|Mean
2739399|NCT00955201|Other Pre-specified|Cholesterol Laboratory Values|Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study|Baseline||||mg/dL||Standard Deviation|Mean
2739400|NCT00955201|Other Pre-specified|Triglyceride Laboratory Values|Laboratory triglyceride values at baseline entry into study|Baseline||||mg/dL||Standard Deviation|Mean
2739401|NCT00955201|Other Pre-specified|HbA1C Laboratory Values|Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk|Baseline, 12-wk, 24-wk|A1c testing was performed prior to EMG evaluation so there are 2/4 additional values for 3/6 month numbers of subjects than is reflected in the statement regarding subject withdrawal in the EMG sections. Total difference = 6 at 6 month evaluation.|||percentage of Hb||Standard Deviation|Mean
2739402|NCT00955201|Other Pre-specified|Duration of Diabetes Mellitus|Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study|Baseline||||years||Standard Deviation|Mean
2739403|NCT00955201|Other Pre-specified|Body Mass Index (BMI)|BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m).|Baseline, 12-wk, 24-wk|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation.|||kg/m^2||Standard Deviation|Mean
2739406|NCT00955201|Secondary|Short Form-36V: Mental Component Score|The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year.|initial entry into study, and at 12-wks and 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.|||score on a scale||Standard Deviation|Mean
2739407|NCT00955201|Secondary|Symptom-Limited TMT Maximum METS Achieved (MET)|Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest.|Baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||ratio||Standard Deviation|Mean
2739408|NCT00955201|Secondary|Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)|Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)|Baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||ml/min/kg||Standard Deviation|Mean
2739409|NCT00955201|Secondary|Maximum Respiratory Exchange Ratio (RER) During TMT|Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2.|Baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.|||ratio||Standard Deviation|Mean
2739410|NCT00955201|Secondary|Symptom-Limited TMT Maximum Oxygen Uptake (VO2)|Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)|Baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||ml/min/kg||Standard Deviation|Mean
2739411|NCT00955201|Secondary|Symptom-Limited TMT Maximum Minute Ventilation (VE)|Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)|Baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||liters/min||Standard Deviation|Mean
2739412|NCT00955201|Secondary|Symptom-Limited TMT Maximum Systolic Blood Pressure|Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)|Baseline, 12-wk, 24-wk|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||mmHg||Standard Deviation|Mean
2739413|NCT00955201|Secondary|Symptom-Limited TMT Maximum Heart Rate|Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)|baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||beats per min||Standard Deviation|Mean
2739414|NCT00955201|Secondary|Voluntary Duration of Symptom-Limited TMT|Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)|baseline, 12-wks, 24-wks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp.|||minutes||Standard Deviation|Mean
2739421|NCT00955201|Primary|Sensory Ulnar Nerve Latency|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||ms||Standard Deviation|Mean
2739415|NCT00955201|Secondary|Short Form-36V: Physical Component Score|The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year.|Initial entry into study, 12 and 24 weeks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.|||score on a scale||Standard Deviation|Mean
2739416|NCT00955201|Secondary|Symptom-Limited TMT Blood Glucose Response|Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)|Initial entry into study, 12 and 24 weeks|Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/co-PI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp.|||mg/dl||Standard Deviation|Mean
2739417|NCT00955201|Primary|Peroneal Nerve Conduction Velocity|Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. No data recorded for 1 Sedentary subject at 3 month evaluation. Data shown include responders and non-responders.|||m/s||Standard Deviation|Mean
2739418|NCT00955201|Primary|Peroneal Nerve Latency|Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||ms||Standard Deviation|Mean
2739419|NCT00955201|Primary|Peroneal Nerve Amplitude|Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||mV||Standard Deviation|Mean
2739420|NCT00955201|Primary|Sensory Ulnar Nerve Conduction Velocity|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||m/s||Standard Deviation|Mean
2739436|NCT00955032|Primary|Apathy Evaluation Scale (AES)|The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
2739485|NCT00954447|Secondary|Number of Patients With HbA1c < 7.0 Percent||24 and 52 weeks|FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.|||Participants|||Number
2740733|NCT00946023|Secondary|Incidence of Chronic GVHD|Percentage of participants who experienced chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
2739422|NCT00955201|Primary|Sensory Ulnar Nerve Amplitude|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||uV||Standard Deviation|Mean
2739423|NCT00955201|Primary|Sensory Median Nerve Conduction Velocity|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||m/s||Standard Deviation|Mean
2739424|NCT00955201|Primary|Sensory Median Nerve Latency|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||ms||Standard Deviation|Mean
2739425|NCT00955201|Primary|Sensory Median Nerve Amplitude|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12, and 24 weeks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||uV||Standard Deviation|Mean
2739426|NCT00955201|Primary|Tibial Nerve Conduction Velocity|Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 weeks, 24 weeks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||m/s||Standard Deviation|Mean
2739427|NCT00955201|Primary|Tibial Nerve Latency|Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 weeks, 24 weeks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||ms||Standard Deviation|Mean
2739480|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 32|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 32 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
2739481|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 18|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 18 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
2739428|NCT00955201|Primary|Tibial Nerve Amplitude|Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 weeks, 24 weeks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||mV||Standard Deviation|Mean
2739429|NCT00955201|Primary|Sural Nerve Conduction Velocity|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||m/s||Standard Deviation|Mean
2739430|NCT00955201|Primary|Sural Nerve Latency|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12 wks, 24 wks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||ms||Standard Deviation|Mean
2739431|NCT00955201|Primary|Sural Nerve Amplitude|Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.|Baseline, 12, and 24 weeks|Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation. Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders.|||uV||Standard Deviation|Mean
2739432|NCT00955110|Primary|High VAS - Emax (mm)|"The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line."|High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.|Per Protocol population: Subjects who received all 5 treatments and who had no major protocol deviations or other circumstances that would exclude them from the analysis. The pharmacokinetic and pharmacodynamic analyses were performed using the Per Protocol population. No imputation of missing values was performed.|||mm||Standard Deviation|Mean
2739433|NCT00955032|Secondary|Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
2739434|NCT00955032|Secondary|Beck Depression Inventory-Second Edition (BDI-II)|The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
2739435|NCT00955032|Secondary|Lille Apathy Rating Scale (LARS)|The Lille Apathy Rating Scale (LARS) is a 33-item interviewer administered structured questionaire designed to assess level of apathetic symptoms. The first 3 items are scored from -2 to +2, while the remainder items are scored from -1 to +1. Scores can range between -36 to +36. The more positive the score, the greater level of apathy symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
2739437|NCT00954993|Primary|Apparent Terminal Half-life (t-1/2) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the t-1/2 of vaniprevir. The t-1/2 is the time taken to eliminate half the amount of vaniprevir.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Since only a single liver sample timepoint was obtained from each participant at either 6 or 12 hours, and the 24 hour timepoint was not collected from any participant due to the early termination of the study, the t-1/2 could not be determined.||||||
2739438|NCT00954993|Primary|Concentration of Vaniprevir in the Liver|Participants were treated with vaniprevir on days, 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were collected at 6, 12, and 24 hours postdose to determine the concentration of vaniprevir in the liver.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Participants treated with vaniprevir who had a liver biopsy were analyzed as two separate groups that received 600 mg and 300 mg doses . No biopsies were collected at the 24 hour timepoint.|||nM||Full Range|Median
2739439|NCT00954993|Primary|Area Under the Curve (AUC) (0-12 Hrs) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the AUC of vaniprevir. AUC is the integrated area under the curve for plasma concentration of vaniprevir over time.|6, 12 and 24 hours postdose on day 4 of each period (up to Day 148)|Since only a single liver sample timepoint at either 6 or 12 hours was obtained from each participant, and no 24 hour timepoint was collected from any participant due to the early termination of the study, the AUC (0-12 hrs) was not calculated||||||
2739440|NCT00954941|Primary|Treatment Success Rate|Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.|||percentage of participants|||Number
2739441|NCT00954941|Primary|Participant Responses|Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.|||participants|||Number
2739442|NCT00954915|Secondary|Teplizumab Blood Levels||Day 0 through Day 84|||||||
2739443|NCT00954915|Secondary|Physician's Global Assessment (PGA)|The PGA rates the subject's psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.|Day 0, 14, 28, 63 and 84|||||||
2739444|NCT00954915|Secondary|Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.|Day 0, 14, 28, 63 and 84|||||||
2739445|NCT00954915|Secondary|Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)|The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.|Day 0, 14, 28, 63 and 84|||||||
2739446|NCT00954915|Primary|Adverse Events (AE)|Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.|Day 0 through Day 84|One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.|||Participants|||Number
2739447|NCT00954824|Primary|The Primary Outcome Measure is Plasma Levels of TNF Alpha.||24 hours||||ng/mL||Standard Deviation|Mean
2739448|NCT00954733|Primary|TcCo2 vs PACo2 Difference|Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2|1 hour||||mmHG||Standard Deviation|Mean
2739449|NCT00954707|Secondary|Rate of Non-cardiac Death|Include all deaths due to non-cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
2739450|NCT00954707|Secondary|Rate of Cardiac Death|Include all deaths due to cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
2739451|NCT00954707|Secondary|Rate of Protocol Defined Major Bleeding Complications|Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
2739452|NCT00954707|Secondary|Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)|ARC defined ST classifies ST by type - definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
2739453|NCT00954707|Secondary|Rate of Protocol Defined Stent Thrombosis (ST)|Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
2739454|NCT00954707|Secondary|Rate of Major Adverse Cardiac Events (MACE)|MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).|||participants|||Number
2739455|NCT00954707|Secondary|Rate of Target Vessel Failure (TVF)|Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).|||participants|||Number
2739456|NCT00954707|Secondary|Rate of Clinically Driven Target Vessel Revascularization (TVR)|Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).|||participants|||Number
2739457|NCT00954707|Secondary|Rate of Clinically-driven Target Lesion Revascularization (TVR)|"Defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA."|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
2739458|NCT00954707|Secondary|Rate of Procedure Success|Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.|From post- procedure to hospital discharge, up to 39 days|Intent-to-Treat Population|||participants|||Number
2739459|NCT00954707|Secondary|Rate of Lesion Success|Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.|From post- procedure to hospital discharge, up to 39 days|The total number of lesions the Intent-to-Treat population had at the beginning of the study|||Lesions|Participants||Number
2739460|NCT00954707|Secondary|Rate of Device Success|A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.|From post- procedure to hospital discharge, up to 39 days|The total number of devices the Intent-to-Treat patients used in the study.|||Devices|Participants||Number
2739461|NCT00954707|Primary|Phase I: the Rate of Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.|12 months|Active subjects in the ITT population at 12-month post procedure|||participants|||Number
2739462|NCT00954681|Primary|Maximum Tolerated Dose of Quetiapine|Mean maximum tolerated dose of quetiapine|assesssed daily during 8 weeks of study, mean maximum tolerated dose reported|Mean maximum dose of quetipaine achieved|||milligrams||Full Range|Mean
2739463|NCT00954538|Primary|Least Squares (LS) Mean [18F]MK-3328 SUVR in Brain Posterior Cingulate Gyrus in AD Participants and HE Participants|Using PET brain images acquired after the second dose of [18F]MK-3328, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. Posterior cingulate gyrus SUVR was calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum.|60-90 minutes after second dose|All participants who received a second dose of [18F]MK-3328 in Part III of study|||ratio||95% Confidence Interval|Least Squares Mean
2739482|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 12|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 12 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
2739483|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 6|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 6 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
2739484|NCT00954447|Secondary|Number of Patients Lowering HbA1c by at Least 0.5 Percent||24 and 52 weeks|FAS (NCF)|||Participants|||Number
2739464|NCT00954538|Primary|Mean Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR) in AD Participants and HE Participants|Using PET brain images acquired after dosing, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices).|60-90 minutes post dose|All participants who received [18F]MK-3328 in Part II of study|||ratio||Standard Deviation|Mean
2739465|NCT00954538|Primary|Organ Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, ROIs were drawn in all organs showing visible [18F]MK-3328 accumulation. TACs showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The organ effective dose is the equivalent dose in each organ multiplied by a weighting factor for the type of tissue exposed. The unit of organ effective dose is Sv.|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study|||µSv/MBq||Standard Deviation|Mean
2739466|NCT00954538|Primary|Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, regions of interest (ROIs) were drawn in all organs showing visible [18F]MK-3328 accumulation. Time activity curves (TACs) showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA (Organ Level Internal Dose Assessment) software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The total radiation exposure to the body is expressed as the effective dose, which is the sum of the equivalent doses in each organ multiplied by a weighting factor for the type of tissue exposed. Effective dose is the primary surrogate for radiation risk. The unit of effective dose is the Sievert (Sv).|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study|||µSv/MBq||Standard Deviation|Mean
2739467|NCT00954538|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328|||participants|||Number
2739468|NCT00954538|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328|||participants|||Number
2739469|NCT00954512|Primary|Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (safety) consisted of all participants who received ≥1 dose of study drug.|||Participants|||Number
2739470|NCT00954512|Primary|Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response|Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (efficacy) consisted of all participants who received ≥1 dose of study drug and were evaluable for this outcome measure.|||Participants|||Number
2739471|NCT00954447|Other Pre-specified|Number of Patients With HbA1c < 6.5 Percent||24 and 52 weeks|FAS (NCF)|||Participants|||Number
2739472|NCT00954447|Secondary|Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment||Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner|FAS (OC)|||mmol*hr/L||Standard Deviation|Mean
2739473|NCT00954447|Secondary|Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment|Mean Daily Glucose was calculated using the 8-point blood glucose profile|Baseline, 24 and 52 weeks|FAS (OC)|||mmol*hr/L||Standard Deviation|Mean
2739474|NCT00954447|Secondary|Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment|Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)|||International units (IU)||Standard Error|Mean
2739475|NCT00954447|Secondary|Change From Baseline in FPG||Baseline, 6, 12, 18, 24, 32 and 40 weeks|FAS, observed cases (OC)|||mg/dL||Standard Deviation|Mean
2739476|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment||Baseline and 52 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement|||mg/dL||Standard Deviation|Mean
2739477|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment|Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs|Baseline and 24 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement|||mg/dL||Standard Error|Mean
2739478|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 52|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
2739479|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 40|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 40 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
2766106|NCT00765388|Secondary|Feeling of Security During the Day|The patients feeling of security with the bag during the day|4 weeks|ITT population|||Participants|||Number
2739486|NCT00954447|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)|Baseline and 24 weeks|The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.|||Percentage||Standard Error|Mean
2739487|NCT00954421|Secondary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Either VIM or VO On, and for Both VIM and VO Off (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.~Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).~Either VO or VIM stimulator will be turned on (as opposed to both stimulators, as in outcome measure 1), and change in Tremor Rating Scale scores will be compared. The effects of each individual stimulator will also be compared to both being turned on."|Baseline to Six Months|Patients completing 6 months were tested for VIM and VO both on vs. both off. Score is TRS scale with both off minus both on. Positive value favors DBS.|||units on a scale||Standard Deviation|Mean
2739488|NCT00954421|Primary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Both VIM and VO ON (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.~Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline)."|Change from Baseline to Six Months|All Subjects completing Period 4|||units on a scale||Standard Deviation|Mean
2739489|NCT00954356|Secondary|Treatment Emergent Adverse Events|"Adverse Events were recorded at the time of occurence. Clinically significant findings (if any) in ECG and vital signs assessments and laboratory samples were recorded as adverse events.~Treatment Emergent Adverse Events (TEAEs) are those which either started or worsened following administration of study drug (XPF-001 or placebo)."|48 hours||||Events|||Number
2739490|NCT00954356|Secondary|Time to Rescue Medication|The time of administration of rescue medication (if any) was recorded for each subject and the duration since dosing was calculated.|24 hours||||Minutes||95% Confidence Interval|Median
2739491|NCT00954356|Secondary|Time to Meaningful Relief|"Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).~'Meaningful Relief' was defined as when the relief became 'meaningful' to each individual subject, and was not necessarily a complete absence of pain. 'Meaningful Relief' could not occur before 'First Perceptible Relief'."|24 hours||||Minutes||90% Confidence Interval|Median
2739492|NCT00954356|Secondary|Time to First Perceptible Relief|Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).|24 hours||||Minutes||95% Confidence Interval|Median
2739493|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID12 is an area calculation encompassing time and the PID scores over the 12 hours following dosing. The minimum possible SPID12 value = -120, the maximum possible = 120.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 12 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
2739494|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID8 is an area calculation encompassing time and the PID scores over the 8 hours following dosing. The minimum possible SPID8 value = -80, the maximum possible = 80.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 8 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
2739495|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID6 is an area calculation encompassing time and the PID scores over the 6 hours following dosing. The minimum possible SPID6 value = -60, the maximum possible = 60.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 6 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
2739496|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID4 is an area calculation encompassing time and the PID scores over the 4 hours following dosing. The minimum possible SPID4 value = -40, the maximum possible = 40.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 4 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
2739541|NCT00953706|Secondary|Part B : Rate of Change From Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part B baseline through Week 64|Part B FAS.|||percent predicted of FEV1 per 336 days||Standard Error|Least Squares Mean
2739497|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 12 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 12-hour observation (TOTPAR 12); TOTPAR 12 is an area calculation incorporating time and relief scores over the 12 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 12 score = 0, maximum possible score = 48."|12 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
2739498|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 8 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 8-hour observation (TOTPAR 8); TOTPAR 8 is an area calculation incorporating time and relief scores over the 8 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 8 score = 0, maximum possible score = 32"|8 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
2739499|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 4 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 4-hour observation (TOTPAR 4); TOTPAR 4 is an area calculation incorporating time and relief scores over the 4 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 4 score = 0, maximum possible score = 16)."|4 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
2739500|NCT00954356|Primary|Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)|"The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24"|6 hours post dose|Published data from an impacted wisdom tooth removal was used to determine a 60 subject study with 2:1 randomisation and a one-sided significance level of 0.10 would have a power of 84.1%. LOCF was used for imputed values and all subjects were included in both the IIT and PP populations for analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2739501|NCT00954187|Primary|Decreased Overall Pain Score as Measured by the Visual Analogue Scale|No data was collected or analyzed. No study procedures were performed.|one month|No subjects were assigned treatment and no study procedures were performed||||||
2739502|NCT00954122|Secondary|Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.|"Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.~Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.~Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).~This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.|||Scores on a scale||Standard Deviation|Mean
2739503|NCT00954122|Secondary|Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale|"Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject's mental. A reduction in score indicates an improvement in the subject's condition. This assessment is based on the improvement since initiation of the study treatment.~Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.|||Scores on a scale||Standard Deviation|Mean
2739504|NCT00954122|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)|"Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. A reduction in score indicates an improvement in the subject's condition. The CGI-S assessment should be based upon the subject's symptoms during the previous week.~Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.|||scores on a scale||Standard Deviation|Mean
2739505|NCT00954122|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.|||Scores on a scale||Standard Deviation|Mean
2739542|NCT00953706|Secondary|Part B : Rate of Change From Part A Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part A baseline through Week 64|Part B FAS.|||percent predicted of FEV1 per 448 days||Standard Error|Least Squares Mean
2744169|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
2739506|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores|Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.|||Scores on a scale||Standard Deviation|Mean
2739507|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.|"Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.~Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.|||Scores on a scale||Standard Deviation|Mean
2739508|NCT00954122|Primary|Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score|PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.|||Scores on a scale||Standard Deviation|Mean
2739509|NCT00954109|Primary|Blood Flow in Response to Oral Glucose Tolerance Tests|Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)|pre and 24 hours post 5-7 days of exercise||||percentage change||Standard Error|Mean
2739510|NCT00954109|Primary|Insulin Sensitivity After 5-7 Days of Exercise|Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).|baseline and 24h after 5-7 days of exercise||||index score||Standard Error|Mean
2739511|NCT00953927|Secondary|To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.|The number (percentage) of infants with QuantiFERON conversions at any time on the study were summarized by treatment group.|15 to 36 months post-vaccination|Per protocol population who were quantiferon negative at baseline.|||participants|||Number
2739512|NCT00953927|Secondary|To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.|Investigations for determining correlates of immune protection to TB will not be completed as planned because the study did not show TB protection in MVA85A/AERAS-485 recipients.|15 to 36 months post-vaccination|||||||
2739513|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.|Frequencies of CD4 and CD8 T cells expressing cytokines (IFN-γ, IL-2 and TNF-α) following stimulation of whole blood with an Ag85A peptide pool were also measured by flow cytometry for a subset of infants.|28 days post-vaccination|Pre-specified population subset|||percentage of cytokine expressing cells||95% Confidence Interval|Median
2739514|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.|An ex vivo IFN-γ ELISPOT assay was used to assess specific T cell responses to an Ag85A peptide pool for a subset of infants.|7 days post-vaccination|Pre-specified population subset|||SFC per million PBMCs||95% Confidence Interval|Median
2739515|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with an Ag85A peptide pool on a subset of infants.|28 days post-vaccination|Pre-specified population subset|||percentage of cytokine expressing cells||95% Confidence Interval|Median
2739516|NCT00953927|Secondary|To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.|The number (percentage) of subjects with a diagnosis of tuberculosis based on clinically-derived tuberculosis (TB) diagnostic criteria were summarized by treatment group for all subjects.|15 to 36 months post-vaccination|Per protocol population|||participants with a diagnosis of TB|||Number
2739556|NCT00953615|Secondary|Soluble Tumor Necrosis Factor - Alpha|Assessment of effect from thalidomide on soluble tumor necrosis factor - alpha compared to baseline values were to be performed at study conclusion.|6 months, baseline||||pg/ml||Standard Deviation|Mean
2739517|NCT00953927|Primary|To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.|Adverse events (AE) were collected for 28 days after vaccination. The subject's parent or guardian recorded information regarding occurrences of solicited adverse events in diary cards through 7 days after vaccination. Serious adverse events (SAE) were collected from the time of study vaccine dosing throughout the entire study. A safety cohort (the first 330 infants enrolled) also had serum chemistry and hematology testing up to 28 days post-vaccination.|AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.|All subjects vaccinated.|||percentage of all subjects vaccinated||95% Confidence Interval|Number
2739518|NCT00953862|Secondary|Change in Clinical Global Impression-- Severity of Illness Score|The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment|||units on a scale||Standard Deviation|Mean
2739519|NCT00953862|Secondary|Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score|The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment|||units on a scale||Standard Deviation|Mean
2739520|NCT00953862|Primary|Change in Adult ADHD Investigator Symptom Rating Scale Score|The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment|||units on a scale||Standard Deviation|Mean
2739521|NCT00953849|Primary|Change in IL-6 Levels.|Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
2739522|NCT00953849|Primary|Change in GM-CSF|Change in GM-CSF stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
2739523|NCT00953849|Primary|Change in IFN-gamma Levels|Change in IFN-gamma stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
2739524|NCT00953849|Primary|Change in IL-2 Levels|Change in IL-2 stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
2739525|NCT00953745|Secondary|Depression Symptom Change on The Montgomery-Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.|Montgomery-Åsberg Depression Rating (MADRS) Scale scores compared between the 6 week Aripiprazole augmentation groups (responds vs. non-responders). Total range of the MADRS is 0 to 60, with a score of greater than 34 indicating severe depression, 20-34 indicating moderate depression, 7-19 mild depression, and 0-6 normal or absent of symptoms.|Week 10 and Week 16 (6 weeks of combined therapy)|MADRS score comparison between ARP responders and nonresponders.|||score on the MADRS scale||Standard Deviation|Mean
2739526|NCT00953745|Primary|Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders|A ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity specifically in a cluster within the right medial caudate (see data below).|Week 10 and Week 16 (6 weeks of combined therapy)|The outcome purpose was to examine mechanism of action of aripiprazole in responders versus nonresponders. Control subjects were age and gender matched to study subjects and underwent one set of scans (fMRI, raclopride and FOPA PET scans) for use as a comparison group for quality control on a non-depressed population and not for data analysis.|||FDOPA ratio in the right medial caudate||Standard Deviation|Mean
2739527|NCT00953719|Secondary|Proportion of Composite Successes|A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.|At final follow-up visit, 24 months or later, up to 72 months|Per Protocol subjects with radiographic endpoints, and including subjects who have been revised (these are composite endpoint failures).|||percentage of participants|||Number
2739528|NCT00953719|Secondary|Harris Hip Score Longitudinal Analysis|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.|6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively|The population for this endpoint analysis is comprised of subjects who had Harris Hip scores at respective follow-up visits minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
2739529|NCT00953719|Secondary|Harris Hip Subscale Score: Range of Motion|The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
2739557|NCT00953615|Secondary|Mayo Risk Score|The Mayo Risk Score estimates the survival probability of a patient with primary sclerosing cholangitis based on the following variables: age, bilirubin, albumin, AST and history of variceal bleeding.|6 months||||units on a scale|||Number
2739530|NCT00953719|Secondary|Harris Hip Subscale Score: Deformity|The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
2739531|NCT00953719|Secondary|Harris Hip Subscale Score: Activities|The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
2739532|NCT00953719|Secondary|Harris Hip Subscale Score: Function|The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
2739533|NCT00953719|Secondary|Harris Hip Subscale Score: Pain|The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
2739534|NCT00953719|Primary|Total Harris Hip Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).|At final follow-up visit, 24 months or later, up to 72 months|The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Least Squares Mean
2739535|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events Per Participant Per Year|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.|||events per participant per year|||Number
2739536|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.|||events|||Number
2739537|NCT00953706|Secondary|Part B : Number of Participants With Pulmonary Exacerbations|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.|||participants|||Number
2739538|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Weight Through Week 64|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Deviation|Mean
2739539|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Sweat Chloride Concentration Through Week 64|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2739540|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in CFQ-R Respiratory Domain Score Through Week 64|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2739543|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS included all participants who received at least 1 dose of study drug during Part B. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Deviation|Mean
2739544|NCT00953706|Secondary|Part A : Rate of Change From Baseline in Weight Through Week 16|As malnutrition is common in participants with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms per 112 days||Standard Error|Least Squares Mean
2739545|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Sweat Chloride Concentration Through Week 16|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2739546|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 16|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2739547|NCT00953706|Primary|Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16|Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.|Part A baseline through Week 16|Part A Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug during Part A. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2739548|NCT00953680|Primary|Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing|30 Hours Post Dose|Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study.|||ng/mL||Standard Deviation|Least Squares Mean
2739549|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of HCTZ|Plasma Area Under the Curve, a measure of drug exposure following dosing|0 to 30 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.|||ng*hr/mL||Standard Deviation|Least Squares Mean
2739550|NCT00953680|Primary|Peak Plasma Concentration (Cmax) for Losartan|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.|36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.|||ng/mL||Standard Deviation|Least Squares Mean
2739551|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of Losartan||0 to 36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.|||ng*hr/mL||Standard Deviation|Least Squares Mean
2739552|NCT00953667|Secondary|Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender||Baseline ( −15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of C-Reactive Protein (CRP).|||mg/L||Inter-Quartile Range|Median
2739553|NCT00953667|Primary|Baseline and Peak TNF-alpha Values as Categorized by Race and Gender||Baseline (−15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of Tumor Necrosis Factor- alpha (TNF-alpha).|||pg/ml||Inter-Quartile Range|Median
2739554|NCT00953654|Primary|Worry Symptoms|"Worry symptoms, hallmark symptoms of GAD, were assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 16-item self-report questionnaire that measures pathological worry symptoms. Participants rate items from 1 not at all typical of me to 5 very typical of me. Scores range from 16 to 80, with higher scores indicated exacerbated worry symptoms. Symptoms were assessed at baseline and at the beginning of the second weekly session during weeks 2, 4, and 6."|Baseline, Week 2, Week 4, Week 6||||Units on a scale (PSWQ)|Participants|Standard Deviation|Mean
2739555|NCT00953654|Primary|Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings|GAD is characterized by persistent excessive or pathologic worry most days for at least 6 months about activities of daily life that is difficult to control and associated with at least 3 of the following symptoms: restlessness, feeling on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep difficulty. Symptoms are not caused by a substance or disorder, but cause significant distress or functional impairment. Remission was measured using the ADIS-IV from 1-16 days following the 6-week intervention.|Pre- and post- 6 week training intervention||||Participants|||Number
2739558|NCT00953615|Secondary|Overall Toxicity and Tolerability|Overall toxicity and tolerability were to be measured by the number of patients with development of neuropathy, increased liver biochemistries, drowsiness, dizziness and orthostatic hypotension.|6 months||||participants|||Number
2739559|NCT00953615|Primary|Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase|The primary outcome was the change in serum liver biochemical parameter levels after 6 months of thalidomide when compared to baseline values. This was to be analyzed using the nonparametric Wilcoxon signed rank test of significance. This was based on the non-normal distribution of serum hepatic biochemical parameters among patients with PSC and the continuous nature of these variables.|6 months, baseline|Analysis was not performed because participant did not complete the study due to adverse events.|||IU/L||Standard Deviation|Mean
2739560|NCT00953576|Secondary|Grade 3-4 Treatment-Related Adverse Events Rate|All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.|Assessed each cycle throughout treatment. Treatment duration in months was a median (range) of 5.4 months (range 1 day-8.3 months). Thus, AEs were evaluated up to 8.3 months.|The analysis dataset is comprised of all participants who ever started treatment.|||proportion of participants||90% Confidence Interval|Number
2739561|NCT00953576|Primary|Plasma Lapatinib Levels [Phase I]|Plasma lapatinib levels were measured after day 28 of KHLAD treatment. Participants were instructed to fast prior to samples being taken.|After first 28 days of KHLAD treatment|The analysis dataset is comprised of participants who received KHLAD and had an evaluable plasma sample after the first cycle (day 28).|||ng/mL||Full Range|Mean
2739562|NCT00953576|Primary|Lapatinib Dose Limiting Toxicity (DLT) [Phase I]|"A DLT is defined as an adverse event (AE) occurring during the first cycle of KHLAD treatment that are determined to related to the Lapatinib or the combination as follows:~Any Grade 3 or greater non-hematological treatment related (possible, probable, or definite attribution) including diarrhea~Grade 4 or greater for hematological toxicities, regardless of attribution.~Grade 3 skin reactions, pulmonary reactions, regardless of attribution."|The evaluation for DLT occurred continuously through one cycle of treatment (28 days).|The analysis dataset is comprised of all DLT evaluable participants.|||participants with DLT|||Number
2739563|NCT00953576|Primary|Lapatinib Maximum Tolerated Dose (MTD) [Phase I]|The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.|The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).|The analysis dataset is comprised of all DLT evaluable participants.|||mg 1x daily|||Number
2739564|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2739565|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2739566|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2739567|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.|||Participants|||Number
2739568|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.|||Participants|||Number
2739569|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2739570|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.|||Participants|||Number
2739571|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.|||Participants|||Number
2739619|NCT00953056|Primary|Number of Participants With Serious Adverse Events|All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.|up to 14 days post vaccination||||Participants|||Number
2739572|NCT00953407|Primary|Lens Awareness|Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.|4 weeks of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||Participants|||Number
2739573|NCT00953329|Primary|Treatment Alefacept|Terminated study|12 weeks (study terminated)|Study terminated||||||
2739574|NCT00953290|Primary|Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment||||cm|Participants|Standard Deviation|Mean
2739575|NCT00953290|Secondary|Adverse Events||At each visit (treatment and follow-up) or until resolution of AEs||||Event|Participants||Number
2739576|NCT00953290|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment|Data was not collected due to termination.|||Participants|||Number
2739577|NCT00953290|Primary|Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment||||cm|Participants|Standard Deviation|Mean
2739578|NCT00953225|Secondary|Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment|Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.|1 year|Each subject had 12 cores measured at each of the pre and post prostate biopsies. The variable summarized is the number of positive cores per subject.|||cores per subject||Inter-Quartile Range|Median
2739579|NCT00953225|Primary|PSA Slope (Trajectory) or the Change in PSA Level Over Time|Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.|1 year (visits # 1-8)|Linear regression was applied to each subject's data with Log(PSA +1) as the outcome. Based on the fitted model, the change in PSA from visit #1 (baseline) to visit #8 (1 year) was calculated. This derived change score is summarized by group.|||ng/mL||Inter-Quartile Range|Median
2739580|NCT00953212|Secondary|Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation||30 days||||Participants|||Count of Participants
2739581|NCT00953212|Secondary|Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation||30 days||||Participants|||Count of Participants
2739582|NCT00953212|Secondary|Number of Participants With Acute Kidney Injury|Using the Akin definition|30 days||||Participants|||Count of Participants
2739583|NCT00953212|Secondary|Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement||30 days||||Participants|||Count of Participants
2739584|NCT00953212|Secondary|Number of Participants With Respiratory Failure Requiring Reintubation||30 days||||Participants|||Count of Participants
2739585|NCT00953212|Secondary|Number of Participants With Postoperative Vasoplegia||30 days||||Participants|||Count of Participants
2739586|NCT00953212|Secondary|Number of Participants With Low Output Heart Failure||30 days||||Participants|||Count of Participants
2739587|NCT00953212|Secondary|Number of Participants With Stroke|Cerebral vascular accident occurring within hospital length of stay|30 days||||Participants|||Count of Participants
2739588|NCT00953212|Secondary|ICU Length of Stay||30 days||||days||Standard Deviation|Mean
2739589|NCT00953212|Secondary|Hospital Length of Stay||30 days||||days||Standard Deviation|Mean
2739590|NCT00953212|Secondary|Number of Participants With Mortality|Mortality measured within length of hospital stay|30 days||||Participants|||Count of Participants
2739591|NCT00953212|Primary|Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery|Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease the incidence of postoperative AF in adult cardiac surgery when compared with beta blockers alone, all combinations failed to show any difference between the four groups. While there have been trials that have shown the addition of amiodarone to beta-blockers to be more effective, this analysis does not support that conclusion.|5 postoperative days|Number of patients who experienced Atrial Fibrillation post-operatively|||Participants|||Count of Participants
2739592|NCT00953199|Secondary|Serum Amylase Levels|serum amylase levels are measure by a blood draw|measurement is taken 2 hrs after ERCP||||units/liter||Full Range|Mean
2739593|NCT00953199|Primary|Post ERCP Pancreatitis is the Primary Outcome.|The primary outcome of interest will be development of acute pancreatitis defined as new or worsening abdominal pain post-ERCP associated with an increase in serum amylase at least 3 times the upper limit of normal.|24-48 hours post-procedure||||participants|||Number
2739594|NCT00953173|Primary|%TBWL|Percent of total body weight change.|5 years|Patients who attended 5 year visit.|||% TBWL||Standard Deviation|Mean
2739595|NCT00953160|Secondary|The Number of Participants With Adverse Events|At each visit (treatment and follow-up) or until resolution of AEs|Up to 6 months after the last treatment||||Participants|||Number
2739596|NCT00953160|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment|||||||
2739597|NCT00953160|Primary|Change in Circumference (cm)||Baseline and 6 months post final treatment||||Centimeters (cm)||Standard Deviation|Mean
2739598|NCT00953147|Secondary|Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.|RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 26|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739599|NCT00953147|Secondary|Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0|RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739600|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739601|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population.|||units on a scale||Standard Error|Least Squares Mean
2739602|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739603|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739604|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739605|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739606|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739607|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all participants analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739620|NCT00953043|Secondary|Median Pressure When Pain Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3||||mm Hg||Full Range|Median
2739608|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739609|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739610|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739611|NCT00953147|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
2739612|NCT00953121|Secondary|Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin|Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity|34 months||||participants|||Number
2739613|NCT00953121|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|40 months||||months||95% Confidence Interval|Median
2739614|NCT00953121|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|40 months||||months||95% Confidence Interval|Median
2739615|NCT00953121|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.|34 months|The number of participants analyzed is lower than the total number in the study for each arm due to the fact that some patients progressed or experienced an adverse event which resulted in being taken off study during the first cycle and thus were never evaluated for radiographic response.|||participants|||Number
2739616|NCT00953121|Primary|6 Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.|6 months||||percentage of participants||95% Confidence Interval|Number
2739617|NCT00953056|Secondary|Number of Infants With Fecal Vaccine Virus Shedding|Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.|Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo|Only participants in Cohort III, infants that received the scheduled dose of vaccination, and for whom the stool samples were available for testing, were included in the analysis for that dose.|||Participants|||Number
2739618|NCT00953056|Primary|Number of Serious Adverse Events|The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.|14 days post vaccination||||Events|||Number
2744170|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
2739621|NCT00953043|Secondary|Median Pressure When Gas Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3||||mm Hg||Full Range|Median
2739622|NCT00953043|Secondary|Median Pressure When First Sensation Was Reported by 50% of Participants|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3||||mm Hg||Full Range|Median
2739623|NCT00953043|Secondary|Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure|Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation.|approximately 1 hour after colonic tube placement, on Day 3||||mm||Standard Error|Mean
2739624|NCT00953043|Primary|Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure|Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|approximately 1 hour after colonic tube placement, on Day 3||||mm||Standard Error|Mean
2739625|NCT00953043|Primary|Postprandial Colonic Tone|Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after standard meal, on Day 3||||mL||Standard Error|Mean
2739626|NCT00953043|Primary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after the colonic tube placement, on Day 3||||mL||Standard Error|Mean
2739627|NCT00953043|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after third dose of lubiprostone or placebo, on Day 3||||mm Hg||Standard Error|Mean
2739628|NCT00953017|Secondary|Polyps Detected|Number of polyps|measured at the time of colonoscopy||||polyps|||Number
2739629|NCT00953017|Secondary|Procedure Time|total colonoscopy procedure time|measured at the time of colonoscopy||||minutes||Standard Deviation|Mean
2739630|NCT00953017|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)|measured at check in to colonoscopy||||units on a scale||Standard Deviation|Mean
2739631|NCT00953017|Primary|The Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.|measured at the time of colonoscopy||||Ottawa Scale||Full Range|Mean
2739632|NCT00952848|Secondary|Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument|Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days|||units on a scale||90% Confidence Interval|Median
2739633|NCT00952848|Secondary|Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy|The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention|2 weeks|Patients treated with MC5A devise for 10 consectuvive days|||mg/24hr||90% Confidence Interval|Median
2739634|NCT00952848|Secondary|Effect of MC5-A on Pain and Neuropathy|Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days|||units on a scale||90% Confidence Interval|Median
2739635|NCT00952848|Primary|Change in Pain Score|"Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15.~Scale is 0 (none) to 10 (severe)"|15 days|Patients treated with MC5A devise for 10 consectuvive days|||units on a scale||90% Confidence Interval|Median
2739636|NCT00952822|Secondary|Infusion Site Pain|Pain was assessed by participants (≥5 years of age) on a visual analog scale (VAS) from 0 (no pain) to 100 (worst possible pain).|Within 5 minutes post-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion|||Scores on a scale||Full Range|Median
2739637|NCT00952822|Secondary|Number and Severity of Infusion Site Reactions|Infusion-related local reactions (including pain, tenderness, erythema, induration, and bruising) and severity were evaluated according to an FDA-defined grading scale (FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; 2007).|Within 5 minutes pre-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion|||Participants|||Number
2739638|NCT00952822|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||IU/dL||Standard Deviation|Geometric Mean
2739639|NCT00952822|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||dL/kg||Standard Deviation|Mean
2739640|NCT00952822|Secondary|Mean Residence Time|Computed as total area under the moment curve divided by the total AUC. Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||hours (h)||Standard Deviation|Mean
2739641|NCT00952822|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||mL/(kg*h)||Standard Deviation|Mean
2739642|NCT00952822|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||hours||Standard Deviation|Mean
2739643|NCT00952822|Secondary|Adjusted in Vivo Incremental Recovery|Increase in factor VIII concentration from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Intent to Treat|||IU/dL:IU/kg||Standard Deviation|Geometric Mean
2739644|NCT00952822|Secondary|Total Area Under the Curve|Total AUC when the concentration is extrapolated to zero using the slope of the β-phase of the model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (intent to treat) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.|||IU*h/dL||Standard Deviation|Geometric Mean
2739645|NCT00952822|Primary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (per protocol) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.|||IU*h/dL||Standard Deviation|Geometric Mean
2739646|NCT00952731|Secondary|Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between protein S coagulation protein in blood samples collected at baseline and before surgery was measured using an ELISA Kit.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage of protein S in blood||Standard Deviation|Mean
2739647|NCT00952731|Secondary|Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor IX coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage of Factor IX protein in blood||Standard Deviation|Mean
2739648|NCT00952731|Secondary|Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor VIII coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage Factor VIII protein in blood||Standard Deviation|Mean
2739649|NCT00952731|Other Pre-specified|E and Z 4-OHT Isomers|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
2739650|NCT00952731|Secondary|Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between vWF coagulation protein in blood samples collected at baseline and before surgery were measured using the immune-turbidimetric assay.|Baseline to immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage of vWF protein in blood||Standard Deviation|Mean
2739651|NCT00952731|Secondary|Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery|Hot flashes were assessed by the Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. This questionnaire measures the incidence of a number of symptoms by asking participants how frequently they experienced them on a scale of 0-4 (0 being Not at All and 4 being Extremely often). BESS questionnaire was administered at baseline and time of surgery. The incidence of vasomotor symptoms (including hot flashes, night sweats, and cold sweats) was measured at baseline (Day 0) and end of treatment prior to surgery (at least 4 weeks later or up to 10 weeks, depending on scheduled surgery date), and changes in the mean score for hot flashes were observed.|Baseline and after 4-10 weeks of treatment|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2739652|NCT00952731|Other Pre-specified|TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF)|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
2739653|NCT00952731|Other Pre-specified|4-OHT Affects Known Tamoxifen-modulated Pathways|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
2739654|NCT00952731|Other Pre-specified|Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
2740111|NCT00950664|Other Pre-specified|Reduction of Tsui Score at Each Visit From Baseline|Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.|8, 12 and 16 weeks after injection||||units on a scale||Standard Deviation|Mean
2739655|NCT00952731|Other Pre-specified|Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery|Concentrations of tamoxifen and its metabolites: 4-hydroxytamoxifen, endoxifen, and NDT were measured in breast tissue, blood, and Nipple Aspirate Fluid (NAF) that was collected on the day of surgery.|Day of surgery (after approximately 4-10 weeks)|||||||
2739656|NCT00952731|Primary|Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment|Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).|Baseline and after 4-10 weeks of treatment|18 total subjects were evaluable for immunohistochemistry marker testing including the Ki-67 labeling index. Of the 26 participants who completed study treatment 2 did not have matching samples available for testing and 6 were excluded because of insufficient DCIS lesion in their samples for testing.|||percentage of 300 DCIS cells||Standard Deviation|Mean
2739657|NCT00952718|Secondary|6 Minute Work|The 6-minute walk work (6Mwork) value was calculated as body mass distance covered during the 6-minute walking test.|baseline and 8 weeks||||Kg*Meter||Standard Deviation|Mean
2739658|NCT00952718|Secondary|Six Minutes Walking Distance|The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.|baseline and 8 weeks||||meter||Standard Deviation|Mean
2739659|NCT00952718|Primary|Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks|MEP was measured after maximal inspiration,while MIP was measured after maximal expiration with each subject seated and wearing a nose-clip. An experienced respiratory therapist strongly urged the subjects to make maximum inspiratory and expiratory efforts at or near residual and total lung capacity, respectively. Determinations were repeated until two technically satisfactory measurements were recorded, with the highest value used for calculations.|baseline and 8 weeks||||cmH2O||Standard Deviation|Mean
2739660|NCT00952705|Secondary|The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
2739661|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
2739662|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
2739663|NCT00952705|Secondary|The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
2739664|NCT00952705|Secondary|The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose||Days 0-14 post dose|The Evaluable Safety Population for solicited symptoms included all participants who received any investigational product and had any solicited symptom data available during the reporting period.|||Percentage of Participants|||Number
2739665|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739666|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739667|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
2739668|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
2766107|NCT00765388|Secondary|Awareness of the Presence of the Product|Evaluates the patients awareness of the presence of the product during use.|4 weeks|ITT population|||Participants|||Number
2739669|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739670|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739671|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739672|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
2739673|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739674|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1176 and 294, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of subjects|||Number
2739675|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586, respectively, received a full dose of investigational product, had post-dose HAI measurement for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739676|NCT00952705|Secondary|The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739677|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739678|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
2739679|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
2739680|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739681|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739682|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739683|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
2739684|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739685|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1175 and 294 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739686|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
2739687|NCT00952705|Primary|The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).|Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.|Day 28 to 35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had a post-dose HAI measurement, and had no protocol violation that could have interfered with generation or interpretation of an immune response.|||Geometric Mean Titer||Full Range|Geometric Mean
2739688|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||hr||Standard Deviation|Mean
2739689|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.|||hr||Full Range|Median
2739690|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2739691|NCT00952653|Secondary|Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||hr||Standard Deviation|Mean
2739692|NCT00952653|Secondary|Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.|||hr||Full Range|Median
2739693|NCT00952653|Secondary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2739694|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2739695|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|1-Hydroxy-Midazolam is an analyte of Midazolam.|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2739696|NCT00952653|Primary|Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
2739697|NCT00952653|Primary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
2739698|NCT00952614|Secondary|Improvement in Macular Edema on Optical Coherence Tomography and Color Photos|Anatomic Change in reading of the size of the area of retinal thickening on color photographs and OCT. Total Macular Volume (TMV) in mm^3, is the calculated volume from the layers of the retina based off OCT imaging.|baseline (preoperatively) to 3 years postoperatively||||improvement in TMV/mm^3||Inter-Quartile Range|Mean
2739699|NCT00952614|Primary|Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts|Outcome measure based on eyes at time points with 10-letter ETDRS score improvement|baseline (preoperatively) to 3 years postoperatively||||letters read correctly||Full Range|Mean
2739700|NCT00952588|Secondary|Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score.|"The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of Worsened was a change from baseline in score of less than or equal to -11."|FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||percentage of participants|||Number
2739701|NCT00952588|Secondary|Percent of Patients With Worsened Trial Outcome Index (TOI)|"TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of Worsened was a change from baseline in score of less than or equal to -9."|TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||percentage of participants|||Number
2739702|NCT00952588|Secondary|Overall Survival (OS)|Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.|Assessed from randomisation until the date of death from any cause, assessed up to 24 months|modified Intent to Treat (mITT)|||months||Full Range|Median
2739703|NCT00952588|Secondary|Time To Complete Response (TTCR)|TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)|Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||days||Inter-Quartile Range|Median
2739704|NCT00952588|Secondary|Disease Free Survival (DFS)|Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.|DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||months||Inter-Quartile Range|Median
2739705|NCT00952588|Secondary|Duration of Response (DoR): Stage I and Transition Phase|DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I.|DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||days||Inter-Quartile Range|Median
2739706|NCT00952588|Primary|Percentage of Patients With Overall Complete Response for Stage I|Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence.|IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (ITT)|||percentage of participants|||Number
2739707|NCT00952523|Primary|Facial Irritation and Cutaneous Effects|Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.|three weeks||||Scores on a Scale||Standard Deviation|Mean
2739708|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose).|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||h*U/L||Standard Deviation|Mean
2739709|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax).|Time at maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||hours||Standard Deviation|Mean
2739710|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||U/L||Standard Deviation|Mean
2739711|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||h*U/L||Standard Deviation|Mean
2739712|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||hours||Standard Deviation|Mean
2739713|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||U/L||Standard Deviation|Mean
2739714|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Pyridoxal-5'-Phosphate (PLP)|Change from Baseline to Week 24 in Plasma PLP|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||ng/mL||Standard Deviation|Mean
2739715|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Plasma Inorganic Pyrophosphate (PPi)|Change from Baseline to Week 24 in Plasma PPi|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||uM||Standard Deviation|Mean
2739716|NCT00952484|Secondary|Change in Height (Z-scores)|Change from Baseline to Week 24 in Height Z-Score. Height Z-Scores assigned based on Centers for Disease Control (CDC) growth charts and methodology.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||Height Z score||Standard Deviation|Mean
2739717|NCT00952484|Secondary|Change in Osteomalacia - Mineralization Lag Time (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in mineralization lag time.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||days||Standard Deviation|Mean
2739718|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Volume/Bone Volume (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid volume/bone volume (%), calculated as the absolute difference of the Baseline and Week 24 percentages.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||percentage points||Standard Deviation|Mean
2739719|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Thickness (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid thickness.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||um||Standard Deviation|Mean
2739720|NCT00952484|Primary|Change in Rickets Severity on Skeletal Radiographs From Baseline to Week 24 as Measured by the Radiographic Global Impression of Change (RGI-C) Scale|A 7-point RGI-C (radiographic global impression of change) score was used to rate change in rickets severity. Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings.|Baseline and Week 24|ITT population, which included randomized patients that received treatment with asfotase alfa, even if discontinued or lost to follow-up. The last assessment prior to Week 24 is used for missing Week 24 data; patients with no post-baseline assessments imputed as having no change. A historical control group is used for comparison.|||units on a scale||Full Range|Median
2739721|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2739722|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2739723|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months|Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2739724|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2739725|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population|||Participants|||Number
2739726|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population|||Participants|||Number
2739727|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2739728|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.|||Participants|||Number
2739729|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population|||Participants|||Number
2739730|NCT00952393|Primary|Blood Levels of Drug|This is the plasma level of the drug as determined by high performance liquid chromatography.|12 hours|This is all participants in the study.|||ng/ml||Standard Deviation|Mean
2739731|NCT00952380|Other Pre-specified|Absorption Rate Constant (Ka) of Dalteparin||4 hours post-dose at each Day 1 to 7 in dose adjustment phase|Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.||||||
2739732|NCT00952380|Other Pre-specified|Volume of Distribution of Dalteparin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|4 hours post-dose at each Day 1 to 7 in dose adjustment phase|Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.||||||
2739733|NCT00952380|Other Pre-specified|Total Body Clearance of Dalteparin|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.|4 hours post-dose at each Day 1 to 7 in dose adjustment phase|Data not reported for the endpoint, since the PK data was collected and analyzed in a pooled analysis, together with data from two external studies; the results of this pooled analysis will be reported separately.||||||
2739734|NCT00952380|Secondary|Number of Dose Adjustments Required to Achieve Prespecified Therapeutic Anti-Xa Levels|During dose adjustment phase, doses were adjusted according to prespecified therapeutic anti-Xa levels in order to achieve target prespecified therapeutic anti-factor Xa levels (0.5 to 1.0 IU/mL). Number of dose adjustments which were done within the specified time window of up to 4 hours post dose on all days (1 to 7) to achieve the prespecified therapeutic anti-Xa levels are reported.|4 hours post-dose at each Day 1 to 7 in dose adjustment phase|PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||dose adjustment||Full Range|Median
2739735|NCT00952380|Secondary|Time to Achieve Prespecified Therapeutic Anti- Factor Xa Levels|Time to achieve the target range (prespecified therapeutic anti- factor Xa levels) was defined as the number of days from the first dose of study drug to the final dose that achieves the target anti-factor Xa level. Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data of Day 1 to 7 is reported.|Day 1 to 7 in dose adjustment phase|PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||days||Full Range|Median
2739736|NCT00952380|Secondary|Maintenance Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Levels|Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Cumulative data for day 1 to 7 has been reported.|4 hours post-dose at each Day 1 to 7 in dose adjustment phase|PD analysis set. Here, “number analyzed” signifies the number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||IU/kg||Standard Deviation|Mean
2739737|NCT00952380|Secondary|Percentage of Participants With Anti-Factor Xa Levels Outside the Prespecified Range at Day 30, 60 and 90 in Follow up Phase|Prespecified therapeutic anti-factor Xa range was 0.5-1.0 IU/mL. The percentage of participants who had anti-factor Xa levels outside the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.|Day 30, Day 60, Day 90 in follow-up phase|PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, “number analyzed” signifies number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||percentage of participants||95% Confidence Interval|Number
2739738|NCT00952380|Secondary|Percentage of Participants Who Remained Within Prespecified Therapeutic Anti-Factor Xa Levels at Day 30, 60 and 90 in Follow up Phase|Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. The percentage of participants who had anti factor-Xa levels within the prespecified therapeutic range at Day 30, 60 and 90 during the follow up phase were reported in this outcome measure.|Day 30, Day 60, Day 90 in follow up phase|PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Here, “number analyzed” signifies number of participants analyzed at specific time points. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||percentage of participants||95% Confidence Interval|Number
2739739|NCT00952380|Secondary|Time to First Occurrence of Major Bleeding Event|Time to first occurrence of major bleeding event was defined as the time interval (in days) between date of first study treatment and date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter, overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration, bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal or intraspinal).|Baseline up to 28 days after the last dose of study drug (up to Day 132)|The safety analysis set included all the participants who received at least 1 dose of study drug.|||days||95% Confidence Interval|Median
2739740|NCT00952380|Secondary|Number of Participants With Physical Examination Abnormalities of Participants|Physical examinations included head, eyes, ears, nose, throat, neck, heart, chest, lungs, abdomen, extremities, skin, neurological status and general appearance. Abnormality in physical examination was based on investigator's discretion. Only those categories in which at least 1 participant had abnormality were reported.|Screening, Visit 2 (Baseline), Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 30), Visit 6 (Day 60), Visit 7 (Day 90)|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||Participants|||Count of Participants
2739741|NCT00952380|Secondary|Absolute Values of Body Length of Participants||Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||centimeter||Full Range|Median
2739742|NCT00952380|Secondary|Absolute Values of Body Temperature of Participants||Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||degree celsius||Full Range|Median
2739743|NCT00952380|Secondary|Absolute Values of Respiratory Rate of Participants|Respiratory rate was defined as the number of breaths per minute.|Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||breaths per minute||Full Range|Median
2739744|NCT00952380|Secondary|Absolute Values of Weight of Participants||Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||kilograms||Full Range|Median
2739745|NCT00952380|Secondary|Absolute Values of Height of Participants||Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||centimeters (cm)||Full Range|Median
2739746|NCT00952380|Secondary|Absolute Values of Heart Rate (HR) and Pulse Rate (PR) of Participants|Heart rate and pulse rate of participants were measured in terms of beats per minute.|Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||beats per minute (bpm)||Full Range|Median
2739747|NCT00952380|Secondary|Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSBP) in Participants||Baseline, Day 1, Day 2, Day 30, Day 60, Day 90|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here number analyzed signifies the number of participants evaluable at specific time points."|||millimeters of mercury (mmHg)||Full Range|Median
2739748|NCT00952380|Secondary|Number of Participants With Laboratory Abnormalities|Criteria:hematology:hemoglobin, hematocrit, erythrocytes less than(<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN),leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/Leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN, activated partial thromboplastin time, prothrombin time, prothrombin international normalized ratio >1.1* ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1* ULN, phosphate <0.8* LLN >1.2* ULN, glucose <0.6*LLN >1.5*ULN, estimated(est) creatinine clearance, est GFR modified and bedside schwartz, >1.0* ULN. Urinalysis: creatinine >1.0*ULN.|Baseline up to 104 days|"The safety analysis set included all the participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2739749|NCT00952380|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after the last dose of study drug (up to Day 132) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after the last dose of study drug (up to Day 132)|The safety analysis set included all the participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2739750|NCT00952380|Secondary|Percentage of Participants With Major and Minor Bleeding Event|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: fatal bleeding, bleeding accompanied by a decrease in hemoglobin of at least 2 grams per deciliter 24 hours, Overt bleeding deemed by the attending physician to necessitate permanent discontinuation of trial medication, Overt bleeding deemed by the attending physician to be unrelated to the participant's underlying condition and accompanied by blood product administration or bleeding occurred at a critical site (intraocular, intracranial, retroperitoneal). A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major or clinically relevant no major bleeding (bleeding resulting in any medical or surgical interventions but which did not meet the criteria for major bleeding).|Baseline up to 28 days after the last dose of study drug (up to Day 132)|The safety analysis set included all the participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2739751|NCT00952380|Secondary|Percentage of Participants With Clinical Response of Progression, Regression, Resolution and No Change in Venous Thromboembolism (VTE)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. PE is a blood clot in the lungs. Clinical response of progression was defined as progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. Clinical response of regression: Regressed clot burden utilizing the same imaging modality as the screening visit. Clinical response of resolution: Thrombus resolution of the qualifying event measured by repeat imaging at the end of study (EOS) visit.|Baseline up to 28 days after the last dose of study drug (up to Day 132)|The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this OM was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||percentage of participants||95% Confidence Interval|Number
2739752|NCT00952380|Secondary|Time to First Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)|It was defined as the time interval (in days) between date of first study treatment and date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot breaks, loose and travels in the blood, this is called VTE. VTE was confirmed by at least one radiographic test and was defined as any new or progressive VTE whose signs and symptoms (identified by the investigator) included: objective swelling or tenderness, pitting edema, erythema or cyanosis.|Baseline up to 28 days after the last dose of study drug (up to Day 132)|The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.|||days||95% Confidence Interval|Median
2739753|NCT00952380|Secondary|Number of Participants With New or Progressive Symptomatic Venous Thromboembolism (VTE)|Symptomatic VTE defined as new or progressive signs and symptoms as judged by the investigator including but not limited to: objective swelling, pain or tenderness, pitting edema, erythema or cyanosis. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis.|Baseline up to 28 days after the last dose of study drug (up to Day 132)|The PD analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase. Data for this outcome measure (OM) was not planned to be collected and analyzed for age group of >=0 to <8 weeks.|||Participants|||Count of Participants
2740300|NCT00949988|Primary|Phase I: To Determine the Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) of D+R Therapy in Patients With Relapsed/Refractory CLL||1 year|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2739754|NCT00952380|Secondary|Percentage of Participants Who Achieved Prespecified Therapeutic Anti- Factor Xa Levels|Prespecified therapeutic anti-factor Xa level was 0.5-1.0 IU/mL. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure.|Day 1 to 7 in dose adjustment phase|Analysis population included all the participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2739755|NCT00952380|Primary|Median Dose of Dalteparin Required to Achieve Prespecified Therapeutic Anti- Factor Xa Level|Prespecified therapeutic anti-factor Xa level was 0.5-1.0 international unit per milliliter (IU/mL). Cumulative data of Day 1 to 7 has been reported.|4 hours post-dose at each Day 1 to 7 in dose adjustment phase|The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and achieved therapeutic range of anti-factor Xa during dose adjustment phase.|||IU/mL||Full Range|Median
2739756|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).|Day 1|PP|||relative risk||Standard Error|Mean
2739757|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).|Day 1|PP|||relative risk||Standard Error|Mean
2739758|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae|Risk factors include age of mother bearing (less than or equal to [<=] 30 years versus [vs] more than [>] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi [RMB], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to [>=] 10000 RMB); whether have brothers or sisters (yes vs no).|Day 1|PP|||relative risk||Standard Error|Mean
2739759|NCT00952367|Secondary|Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.|||percentage of isolates|||Number
2739760|NCT00952367|Secondary|Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.|||percentage of isolates|||Number
2739761|NCT00952367|Secondary|Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics|Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.|||percentage of isolates|||Number
2739762|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.|||percentage of participants|||Number
2739763|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.|||percentage of participants|||Number
2739764|NCT00952367|Primary|Percentage of Participants With Serotypes of Streptococcus Pneumoniae|Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.|||percentage of participants|||Number
2739765|NCT00952367|Primary|Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.|Day 1|Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site.|||percentage of participants|||Number
2739766|NCT00952341|Secondary|Time to First Vomiting Episode in Cycle 1|Time from administration of chemotherapy to first vomiting episode.|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Hours||Standard Error|Mean
2739786|NCT00952289|Secondary|Overall Survival Time - Extended Data|Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population|||weeks||95% Confidence Interval|Median
2739767|NCT00952341|Secondary|Proportion of Participants With No Impact on Daily Life in Cycle 1|"The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739768|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739769|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1|Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739770|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739771|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1|"Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739772|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Acute Phase of Cycle 1|"Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739773|NCT00952341|Primary|Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
2739774|NCT00952315|Secondary|Post-operative Complications|Number of participants who experienced surgery-related post-op complications|Post-operative Days 2 and 3||||Participants|||Count of Participants
2739775|NCT00952315|Secondary|Length of Stay|Number of days participants were in hospital. Operative day is Day 1.|Post-operatively||||Days||Standard Deviation|Mean
2739776|NCT00952315|Secondary|RBC Transfusion|Number of participants who required a blood transfusion post-operatively|Post-operatively <24 hours||||Participants|||Count of Participants
2739777|NCT00952315|Secondary|EBL>400mL|Number of participants with an estimated blood loss greater than 400mL|Intra-operatively||||Participants|||Count of Participants
2739778|NCT00952315|Secondary|Use of Other Device|Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite|Intra-operatively||||Participants|||Count of Participants
2739779|NCT00952315|Secondary|Nephrostomy Tube Placed|Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure|Intra-operatively||||Participants|||Count of Participants
2739780|NCT00952315|Secondary|Ureteral Stent Placed|Participants requiring a ureteral stent to be placed after initial stone removal procedure|Intra-operatively||||Participants|||Count of Participants
2739781|NCT00952315|Secondary|Secondary Procedure Required|Number of participants who required a secondary kidney stone removal procedure|Within three days of initial procedure||||Participants|||Count of Participants
2739782|NCT00952315|Secondary|Stone-free After First Procedure|Number of participants deemed stone-free after initial stone-removal surgery|Post-operative Day 1||||Participants|||Count of Participants
2739783|NCT00952315|Primary|Stone Clearance Time in mm2/Min|Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)|collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket||||mm^2/min||Standard Deviation|Mean
2739784|NCT00952289|Secondary|Overall Survival Time at Week 144|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population|||probability||95% Confidence Interval|Number
2739785|NCT00952289|Secondary|Overall Survival at Week 144|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population|||participants|||Number
2739787|NCT00952289|Secondary|Overall Survival - Extended Data|Overall survival is reported here by the number of deaths from randomization until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population|||participants|||Number
2739788|NCT00952289|Secondary|Overall Survival Time|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population|||weeks||95% Confidence Interval|Median
2739789|NCT00952289|Secondary|Overall Survival|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population|||participants|||Number
2739790|NCT00952289|Secondary|Change From Baseline to Week 24 in Total Symptom Score|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|This analysis only includes patients who had a non-missing change from Baseline to Week 24. Data collected after the date of treatment cross over were not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2739791|NCT00952289|Secondary|Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|ITT evaluable population included patients with Baseline data and who did not have a 0 total score at both Baseline & Week 24; data measured after the cross over date were excluded. Patients who withdrew, met cross over criteria prior to Week 24 or had a 0 Baseline score & a nonzero/missing score at Week 24 were considered not meeting the endpoint.|||participants|||Number
2739792|NCT00952289|Secondary|Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The duration of ≥ 35% reduction from Baseline in spleen volume was defined as the longest duration of consecutive measurements of ≥ 35% reduction observed before the data cut-off date for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or, who subsequently dropped out prior to another assessment. The duration of a ≥ 35% reduction from Baseline in spleen volume was analyzed using the Kaplan-Meier method.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.|||weeks||95% Confidence Interval|Median
2739793|NCT00952289|Secondary|Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.|||proportion of participants||95% Confidence Interval|Number
2739794|NCT00952289|Primary|Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24|Spleen volume was assessed by magnetic resonance imaging (MRI) or by computed tomography (CT) scans if MRI was not suitable, and analyzed by a blinded central laboratory reader. Patients who withdrew, crossed over to ruxolitinib prior to the visit, or had a missing value at the visit were considered non-responders.|Baseline and Week 24|Intent-to-treat (ITT) population included all subjects randomized in the study. Treatment groups for this population were defined according to the treatment assignment at randomization. One patient was not included in the analysis due to a missing baseline spleen volume value.|||participants|||Number
2739795|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.|||Participants|||Number
2739830|NCT00951899|Secondary|Lipid Values|Lipids are fat-like substances in the blood.|Baseline, 12 weeks||||mmol/l||Standard Error|Mean
2740015|NCT00950937|Secondary|Neutrophil Count|Neutrophil count at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||Cell/ul of blood||Inter-Quartile Range|Median
2739796|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.|||Participants|||Number
2739797|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.|||Titers||95% Confidence Interval|Geometric Mean
2739798|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.|||Participants|||Number
2739799|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.|||Participants|||Number
2739800|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.|||Titers||95% Confidence Interval|Geometric Mean
2739801|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.|||Participants|||Number
2739802|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.|||Participants|||Number
2739803|NCT00952211|Secondary|Hospital Anxiety and Depression (HADS) Scale -Depression Subscale|HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms|10 days after beginning CPAP treatment||||units on a scale||Standard Deviation|Mean
2739804|NCT00952211|Primary|Profile of Mood States (POMS) - Fatigue Subscale|POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue|10 days after beginning CPAP treatment|Data only available for 2 subjects; one subject did not provide data for this questionnaire.|||units on a scale||Standard Deviation|Mean
2739805|NCT00952133|Secondary|Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery|Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery.|Pre-op through 96 hours post-op||||participants|||Number
2739806|NCT00952133|Primary|Complete Response Rate|A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.|Pre-op through 72 hours post emergence from anesthesia||||participants|||Number
2739807|NCT00952120|Secondary|Percentage of Wounds With Total Skin Graft Loss|For each wound, whether there was total skin graft loss by Day 4 or 5 was determined.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables)|||percentage of wounds|Participants||Number
2739808|NCT00952120|Primary|Percentage of Wounds With Complete Skin Graft Take|For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables).|||percentage of wounds|Participants||Number
2739809|NCT00952081|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)||intraoperatively and 90 min after surgery||||participants|||Number
2739810|NCT00952068|Secondary|Number of Participants With Adverse Events|All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.|6 hours|Safety population: includes all patients who received the dose of the study medication.|||participants|||Number
2739831|NCT00951899|Secondary|Rate of Meal Glucose Disappearance (Meal Rd)|Meal Rd is the rate at which glucose leaves the systemic circulation. It was measured using a triple-tracer mixed meal and reported in micromols over 6 hours. Meal Rd was calculated by subtracting the change in glucose mass from the overall rate of glucose appearance (i.e., meal Ra + EGP).|Baseline, 12 Weeks||||micromol/6h||Standard Error|Mean
2739811|NCT00952068|Secondary|Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose|PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.|Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||ng/ml||Standard Deviation|Mean
2739812|NCT00952068|Secondary|Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier.  How would you rate the pain relief the study medication has given you? ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF)."|3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||participants|||Number
2739813|NCT00952068|Secondary|Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. What is your current level of pain intensity? 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF)."|Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||participants|||Number
2739814|NCT00952068|Primary|Time to Onset of Perceptible Pain Relief|Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.|6 hours|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||minutes||95% Confidence Interval|Median
2739815|NCT00951912|Secondary|Total Energy Intake at Follow-up|The energy intake was evaluated by 3 days dietary records.|an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.|The number of participants for analysis was determinted by intention to treat|||kcal||Standard Deviation|Mean
2739816|NCT00951912|Secondary|Urinary Genistein|Urinary genistein excretion|3 months|The number of participants for analysis was determinted by the number of participants who supplied the urine samples at the 3-month test|||ug/ml||Standard Deviation|Geometric Mean
2739817|NCT00951912|Secondary|Urinary Daidzein|Urinary daidzein excretion|3 months|The number of participants for analysis was determinted by the number of participants who provided urine samples at the 3-month test|||ug/ml||Standard Deviation|Geometric Mean
2739818|NCT00951912|Secondary|Total Urinary Isoflavones||3 months|The number of participants for analysis was determinted by the participants who provided the urine samples at the 3-month test.|||ug/ml||Standard Deviation|Geometric Mean
2739819|NCT00951912|Primary|Percentage Change in Low Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
2739820|NCT00951912|Primary|Percentage Change in High Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months||||Percentage of change||Standard Deviation|Mean
2739821|NCT00951912|Primary|Percentage Change in Triglyceride|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
2739822|NCT00951912|Primary|Percentage Change in Total Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
2739823|NCT00951912|Primary|Percentage Change in QUICKI|"QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.~The percentage change was caculated as (6th month value-baseline value)/baseline value*100%"|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
2739824|NCT00951912|Primary|Percentage Change in HOMA-IR|HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
2739825|NCT00951912|Primary|Percentage Change in Fasting Plasma Insulin|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants was determinted by intention to treat|||percentage of change||Standard Deviation|Mean
2739826|NCT00951912|Primary|Percentage Change in AUC of Glucose|values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of patticipants was determinted by intention to treat|||percentage of change||Standard Deviation|Mean
2739827|NCT00951912|Primary|Percentage Change in HbA1C|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants analyzed was determinted by intention to treat.|||percentage of change||Standard Deviation|Mean
2739828|NCT00951912|Primary|Percentage Change in 120-minutes Postload Plasma Glucose|(6th month value-baseline value)/baseline*100%|Baseline, 6 months|All participants were determinted by intention to treat|||percentage of change||Standard Deviation|Mean
2739829|NCT00951912|Primary|Percentage Change in Fasting Plasma Glucose|(6th month value-baseline value)/baseline value*100%|Baseline,6 months|the number of participants for analysis was determined by intention to treat|||percentage of change||Standard Deviation|Mean
2739832|NCT00951899|Secondary|Rate of Meal Glucose Appearance (Meal Ra)|Meal Ra was measured using a triple-tracer mixed meal and reported in micromols in 6 hours. Meal derived glucose is a function of both gastric emptying and splanchnic meal extraction. Meal Ra was calculated by multiplying rate of appearance of [1-^13C] glucose (obtained from the infusion rate of [6-^3H] glucose and the clamped plasma ratio of [6-^3H] glucose and [1-^13C] glucose) by the meal enrichment.|Baseline, 12 Weeks||||micromol/6h||Standard Error|Mean
2739833|NCT00951899|Secondary|Fasting Endogenous Glucose Production (EGP)|EGP was measured using a triple-tracer mixed meal and calculated using the Steele's model, reported in micromoles per kilogram per minute.|Baseline, 12 Weeks||||micromol/kg/min||Standard Error|Mean
2739834|NCT00951899|Secondary|Insulin Concentration|Fasting insulin levels were measured in the plasma using a chemiluminescence assay and is reported in nanomoles over 6 hours.|Baseline, 12 Weeks||||nmols/6 hrs||Standard Error|Mean
2739835|NCT00951899|Secondary|Glycosylated Hemoglobin (HbA1c)|HbA1c is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.|Baseline, 12 weeks||||Percentage of hemoglobin||Standard Error|Mean
2739836|NCT00951899|Secondary|Plasma Glucose Concentration|Fasting glucose concentrations were measured at baseline and 2 hours post-meal using the glucose oxidase method.|Baseline, 12 Weeks||||mmol/L||Standard Error|Mean
2739837|NCT00951899|Secondary|Total Fasting Glucagon-Like Peptide-1 (GLP-1) Concentration|GLP-1 is thought to increase insulin secretion and was measured in the blood and reported in picomoles per liter.|Baseline, 12 weeks||||pmol/L||Standard Error|Mean
2739838|NCT00951899|Primary|Total Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|Baseline, 12 weeks|Intent to treat analysis population.|||DItot (10^-14 dl/kg/min^2 per pmol/l)||Standard Error|Mean
2739839|NCT00951821|Secondary|Beck Suicide Scale - Adolescent Response|measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation. These data refer to adolescent respondents. The outcome is a change score so range is from -38 to 38.|Measured at 12 months|intent to treat|||units on a scale||Standard Error|Mean
2739840|NCT00951821|Primary|Beck Depression Inventory - Adolescent Report, Change in Symptom Level|self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression. The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.|12 months|intent to treat|||change in BDI (-60 to 60 possible range)||Standard Error|Mean
2739841|NCT00951808|Primary|Acute Chest Syndrome|First occurence of positive infiltrate on chest x-ray|Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.|Of 237 enrolled subjects, 27 subjects who received a transfusion and 7 subjects who had insufficient sPLA2 measurements were excluded. Therefore, two hundred and three (203) subjects were included in the analysis. Results were not reported by Arm due to the lack of enrollment.|||participants|||Number
2739842|NCT00951665|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the first day of study treatment to documented disease progression or death on study i.e., death due to any cause within 30-days of last dose of study treatment, whichever occurs first.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.|||months||Full Range|Median
2739843|NCT00951665|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR, PR, or stable disease (SD) of 6 months or more duration as assessed by the investigator. CR and PR are identified in previous outcome measure. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.|||percentage of participants|||Number
2739844|NCT00951665|Secondary|Duration of Objective Response|Duration of OR is only calculated for participants with OR and is defined as the time from the first tumor assessment that supports the participant`s OR to disease progression or death.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with OR were considered for this outcome measure.|||months||95% Confidence Interval|Median
2739845|NCT00951665|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Participants with measurable disease (at least one lesion 2 centimeters [cm] or more on computed tomography (CT) scan or 1 cm or more on spiral CT scan) were considered for OR. ORR is defined as the percentage of patients with a complete response (CR)/partial response (PR) determined on two consecutive tumor assessments at least 4 weeks apart based on modified Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). CR defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR defined as at least 30 percent decrease in sum of the longest diameters of the target lesions taking as reference the baseline sum longest diameters.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with measurable disease were considered for OR.|||percentage of participants|||Number
2766108|NCT00765388|Secondary|Flexibility of the Product|Evaluation of the ability of the bag to conform with the patients movements (flexibility)|4 weeks|ITT population|||Participants|||Number
2739846|NCT00951665|Primary|Number of Participants With Change From Baseline in Cardiac Function|Change in cardiac functions i.e., left ventricular ejection fraction (LVEF) and segmental wall abnormalities were assessed by echocardiogram or multigated acquisition scans. LVEF was assessed as change from baseline as 0 to <15%, >=15 to <25%, >=25%, and missing values.|Baseline (30 days prior to study dose), end of Cycle 2, and then every three cycles in Phase Ib and every four cycles in Phase IIa throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|Safety Population: All participants who received at least a single dose of study medication were included.|||participants|||Number
2739847|NCT00951665|Primary|An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-inf]) X (AUMC[0-inf])/AUC[0-inf]) where D is the dose of study drug, AUMC(0-inf) is the area under the first moment curve extrapolated to infinity and AUC(0-inf) is the area under the plasma concentration-time curve from time zero to infinite time. The Vss of paclitaxel (65 mg/m2 and 80 mg/m2) is observed in Cycle 1 (in the absence of T-DM1) and Cycle 2 (in the presence of T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||L/m^2||Standard Deviation|Mean
2739848|NCT00951665|Primary|Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma CL of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis for in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||L/hr/m^2||Standard Deviation|Mean
2739849|NCT00951665|Primary|An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma t1/2 of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||hr||Standard Deviation|Mean
2739850|NCT00951665|Primary|Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma AUC0-inf of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||hr*ng/mL||Standard Deviation|Mean
2739851|NCT00951665|Primary|Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)|Plasma Cmax of paclitaxel (65 mg/m^2 and 80 mg/m^2) for Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1) was estimated by non-compartmental analysis.|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||ng/mL||Standard Deviation|Mean
2739852|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|AUClast for serum T-DM1 and serum total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||day*µg/mL||Standard Deviation|Mean
2739853|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After QW Dose Regimen|Cmax for plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1, and Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||ng/mL||Full Range|Mean
2739854|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|Cmax for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis when T-DM1 was administered QW.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||mcg/mL||Standard Deviation|Mean
2739855|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|AUC0-21 for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre- and post-dose (0.25 and 4 hours and Day 8 [before paclitaxel infusion) for Cycle 1 and pre- and post-dose (0.25 and 4 hours) for Cycle 2 (each cycle of 21 days)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||day*mcg/mL||Standard Deviation|Mean
2766109|NCT00765388|Secondary|Adhesives Ability to Absorb Perspiration|Evaluation of the adhesives ability to absorb perspiration from the skin|4 weeks|ITT population|||Participants|||Number
2739856|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After Q3W Dose Regimen|Cmax of plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||nano gram per milliliter (ng/mL)||Full Range|Mean
2739857|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|Cmax of serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|Pharmacokinetics (PK) population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||microgram per millilitre (Mcg /mL)||Standard Deviation|Mean
2739858|NCT00951665|Primary|Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel|Participants were assessed for toxicity prior to each dose of T-DM1 and paclitaxel; dosing occurred only if the clinical assessment and laboratory test values were acceptable. Dose modifications included dose delayed or any dose reduction. Participants in whom significant toxicities had not recovered to the treatment range defined by the dose modification guidelines at the time of their next scheduled dose, had their dose of T-DM1 and/or paclitaxel delayed or reduced for up to 21 days.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.|||participants|||Number
2739859|NCT00951665|Primary|Number of Participants in Phase IIa of the Study Who Received 12 or More Paclitaxel Doses in Combination With T-DM1 and/or Pertuzumab|Participants in Phase IIa received T-DM1 Q3W and paclitaxel in Group A and T-DM1, paclitaxel, and pertuzumab in Group B.|From Day 1 to 15 weeks|Safety Population: All participants of the phase IIa part of the study who received at least a single dose of study medication and did not have disease progression in the first 12 weeks of study treatment were included.|||participants|||Number
2739860|NCT00951665|Primary|Maximum Tolerated Dose of Paclitaxel When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when paclitaxel (QW) and T-DM1 (Q3W or QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.|||mg/m^2|||Number
2739861|NCT00951665|Primary|Maximum Tolerated Dose of T-DM1 When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of T-DM1 and paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when T-DM1 (Q3W or QW) and paclitaxel (QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.|||mg/kg|||Number
2739862|NCT00951665|Primary|Number of Participants With Dose Limiting Toxicity (DLT) of the Combination of T-DM1 and Paclitaxel When T-DM1 Was Administered on Either an Q3W or QW Schedule for Both With and Without Pertuzumab Treatment|DLT is defined as one of the following toxicities related to study drug during Cycle 1, according to the NCI CTCAE, Version 3: Grade 3 or higher non-hematologic AEs; Grade 3 or higher elevation of serum bilirubin, hepatic transaminases, or alkaline phosphatase; Grade 4 or higher thrombocytopenia; Grade 4 or higher neutropenia; any subjectively intolerable toxicity related to T-DM1, paclitaxel, or pertuzumab; any treatment-related toxicity prohibiting the start of the second cycle of treatment and/or prompting to a dose delay or modification during the DLT observation period, such as prompting a dose reduction at Cycle 2 Day1.|Up to 23 days|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included. Participants in Phase 1b (Regimen 1, Regimen 2, Regimen 3 and Regimen 4 [60 participants]) were considered for this analysis.|||participants|||Number
2739863|NCT00951665|Primary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.|||participants|||Number
2739864|NCT00951561|Primary|Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model|Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.|1 month, 2 months, 3 months, 4 months|Statistical analysis was carried out per plan.|||percentage of uses|Participants||Number
2739865|NCT00951509|Primary|Composite Power Mobility Road Test (PMRT) Scores|The computer-based and the virtual environments will be modeled after and scored similarly to the real world PMRT. The PMRT contains two domains: Structured Elements/Tasks and Unstructured Skilled Driving. The first domains contain 16 tasks that include activities such as passing through standard width doorways, and turning a ninety-degree turn, turning 180 degrees. In both domains, each task is scored from 1 to 4, depending on speed and the number of collisions that occur with obstacles. A total score for the entire test is calculated out of a possible 64 points, and the final score on the test reflects the percentage of total points acquired1. A passing score is a percentage of > 95%.|Baseline in-lab testing|Majority of the participants (41%) had a spectrum of multiple disabilities ranging from stroke, spinal stenosis, osteoarthritis, emphysema, and cerebral degeneration, followed by 11 participants (35%) with spinal cord injury.|||units on a scale||Standard Error|Mean
2766110|NCT00765388|Secondary|Adhesion of the Bag During Use|Evaluation of the adhesion of the base plate around the stoma during use|4 weeks|ITT population|||Participants|||Number
2739866|NCT00951496|Secondary|Patient Reported Nausea|Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much)|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment|Patients evaluable for PRO (Patient Reported Outcomes)/QOL are patients who completed baseline and at least one follow-up assessment|||units on a scale||Standard Error|Least Squares Mean
2739867|NCT00951496|Secondary|Patient Reported Fatigue|Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue.|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment|Patients evaluable for PRO (Patient Reported Outcomes)/QOL. Evaluable patients have completed baseline and at least one follow-up assessment.|||units on a scale||Standard Error|Least Squares Mean
2739868|NCT00951496|Secondary|Patient Reported Neurotoxicity (Ntx)|The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL.|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment|Patients evaluable for PRO(Patient Reported Outcome)/QOL (completed baseline and at least one follow-up assessment).|||Units on a scale||Standard Error|Least Squares Mean
2739869|NCT00951496|Secondary|Patient Reported Quality of Life (QOL)|QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL).|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment|Patients evaluable for PRO (Patient Reported Outcomes)/QOL (completed baseline and at least one follow-up assessment)|||Units on a scale||Standard Error|Least Squares Mean
2739870|NCT00951496|Secondary|Overall Survival|Estimate the median duration of overall survival in months.|Up to 10 years|Intention-to-treat: All enrolled patients|||Months||95% Confidence Interval|Median
2739871|NCT00951496|Secondary|Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0|Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event.|During treatment and up to 30 days after end of treatment|Treated Patients|||Participants|||Count of Participants
2739872|NCT00951496|Primary|Median Progression-free Survival|Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.|Intention-to-treat: All enrolled patients|||months||95% Confidence Interval|Median
2739873|NCT00951483|Secondary|Change in 14-item Perceived Stress Scale (PSS-14)|The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress.|Baseline and 12 weeks|This analysis is restricted to the twenty-three individuals from the intervention cohort had valid PSS-14 responses at baseline and 12 weeks; the healthy control arm is not included, because their PSS-14 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
2739874|NCT00951483|Secondary|Change in Beck Depression Inventory (BDI)|The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-seven individuals from the intervention cohort had valid BDI responses at baseline and 12 weeks; the healthy control arm is not included, because their BDI scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
2739982|NCT00950950|Secondary|Accumulation Ratio|Accumulation ratio was calculated as the ratio of AUC0-28 after the last dose to AUC0-28 after the first dose.|First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||ratio||Standard Deviation|Mean
2739875|NCT00951483|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-A responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-A scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
2739876|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)|The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-D-21 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-21 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
2739877|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)|The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-17 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-17 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
2739878|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)|The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-7 responses at baseline and 12 weeks; the healthy control arm is not included here, because their HAM-D-7 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
2739879|NCT00951483|Primary|C-Reactive Protein at 12 Weeks|To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.|12 weeks|Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40).|||mg/L||Inter-Quartile Range|Median
2739880|NCT00951379|Primary|Dichotomized Clinical Response: Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|Clinical Response assessed according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. Complete Response (CR): Disappearance of all evidence of target AND non-target lesions. Partial Response (PR): greater than or equal to 50% reduction in the sum of the products of diameters of all target lesion(s). Non-target lesions may not increase greater than or equal 25% in size and no new lesion may appear. No Change (NC): No change in the size of the lesion(s) and no new lesions appearing, i.e. anything that is not CR, PR or PD. Progressive Disease (PD): Any increase greater than or equal to 25% in the product of the diameters of any measurable lesions or in the estimated size of non-measurable lesions or the appearance of an unequivocal new lesion.|Response assessed at Week 24 ±1 Week|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
2739881|NCT00951379|Primary|Dichotomized Histologic Response (HR): Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|HR according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. CR: Complete reversal dysplasia/hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree dysplasia/hyperplasia in all biopsied lesion from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable. No Change (NC): No change in degree dysplasia/hyperplasia in all biopsied lesions, anything not CR, PR or PD. Progressive Disease (PD): Any increase in severity histology grade any biopsied lesion. Early premalignant lesion: lesion defined high risk, indicated by presence of one: hyperplasia at high-risk sites (dorsal, lateral or ventral tongue, or floor of mouth) ONLY, or mild dysplasia. Advanced premalignant lesion: lesion with presence of one: moderate dysplasia or severe dysplasia (excluding CIS), erythroplakia with hyperplasia or of any severity of dysplasia.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
2739882|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of PPARG Nucleus and PPARG Cytoplasm|Tissue levels of Peroxisome proliferator-activated receptor gamma (PPARG) Nucleus and PPARG Cytoplasm as indirect measures of pharmacological effect, PPAR gamma assessed by immunohistochemistry. Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed at end of study, and two participants in Placebo were not analyzed for PPARG baseline scores. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
2739883|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of B-cell Lymphoma 2 (Bcl2)|Tissue levels of Bcl2 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported a percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants of 25 overall in the Pioglitazone arm were not analyzed for Bcl2 end of study score and one participant in Placebo was not analyzed for Bcl2 baseline score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
2739884|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of p21|Tissue levels of p21 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for p21 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
2739885|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Ki-67|Tissue levels of Ki-67 for proliferation assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed for Ki-67 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
2739886|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Cyclin D1|Tissue levels of Cyclin D1 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for Cyclin D1 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
2739887|NCT00951379|Secondary|Number of Participants Affected by Adverse Events Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0)|All adverse events (including serious) and clinical laboratory toxicity summarized affected organ system. Reporting based on the NCI CTCAE v4.0 by treatment, details included in later Adverse Event Module of results.|Up to 26 weeks|Population includes all enrolled participants.|||participants|||Number
2739888|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Alcohol Use|Alcohol use will be summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical and pathological response assessed using statistical regression models in an exploratory fashion. Heavy drinkers are participants who drank every day; Light drinkers are participants who drank on some days; Non-drinkers are former drinkers or those who never drank alcohol.|Up to 26 weeks|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
2739889|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Tobacco Use|Tobacco use summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical response assessed.|Up to 26 weeks|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
2739890|NCT00951379|Secondary|Number of Participants With Level of C-reactive Protein in Plasma Decrease From >5.0 mg/L to <= 5.0 mg/L From Baseline to End of Study|The longitudinal regression models for analysis of the change in CRP in plasma will be used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates.|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 20 evaluable specimens at baseline & 20 at end of study with 2 of those not available for the CRP>5 baseline measure & Placebo's 25 had 25 evaluable at baseline & 21 evaluable at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participants needed 1/+ dose of treatment.|||participants|||Number
2739891|NCT00951379|Secondary|Number of Participants With >5.0 mg/L in Level of C-reactive Protein in Plasma|"Degree of change of C-reactive protein (CRP) in plasma serum via blood tests.~The longitudinal regression models for analysis of the change in CRP in plasma used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates."|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 24 evaluable specimens at baseline & 20 evaluable at end of study with 2 of those not available for CRP>5 baseline measure: Placebo's 25 had 25 evaluable specimens at baseline & 21 at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participant needed 1/+ dose of treatment.|||participants|||Number
2739892|NCT00951379|Primary|Overall Response <Clinical and Histologic Response Defined as 50% or Greater Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia>|Overall Dichotomized Clinical and Histologic Response defined as 50% or greater reduction in sum of the measured products of perpendicular dimensions of the target lesion(s) or improvement in the degree of dysplasia or hyperplasia where complete (CR) or partial response (PR) in either clinical or histologic outcome assessed according to criteria given recorded as Response or No Response and analyzed as a dichotomous variable. Clinical Response = CR: Disappearance all evidence target & non-target lesions; PR: >/=50% reduction in sum products of diameters all target lesion(s). Non-target lesions may not increase >/=25% in size & no new lesion. Histologic Response = CR: Complete reversal of dysplasia or hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree of dysplasia or hyperplasia in all biopsied lesion(s) from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
2739983|NCT00950950|Secondary|Terminal Half-life (t1/2,z) of Romosozumab|Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.|Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||days||Standard Deviation|Mean
2739893|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
2739894|NCT00951275|Secondary|Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
2739895|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score|"Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement."|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
2739896|NCT00951275|Secondary|SF-HLQ Hindrance Score|"Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score)."|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
2739897|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||hours||Standard Deviation|Mean
2739898|NCT00951275|Secondary|Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||hours||Standard Deviation|Mean
2739899|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter.|||days||Standard Deviation|Mean
2739900|NCT00951275|Secondary|Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||days||Standard Deviation|Mean
2739901|NCT00951275|Secondary|Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin||Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2739902|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in DAS28 Score|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population|||percent change from baseline||Standard Deviation|Mean
2766111|NCT00765388|Secondary|Removal of the Bag|How easy/difficult it was to remove the bag|4 weeks|ITT population|||Participants|||Number
2739903|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by DAS28 Category|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2739904|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (<)3.2 and improvement from baseline of >1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of >5.1 and improvement from baseline of >1.2; No response was defined as a DAS28 score of >5.1 and improvement from baseline of <1.2. Participants who discontinued prematurely were identified as non-responders.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2739905|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in ESR|ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr.|Week 24|ITT population|||percent change in mm/hr||Standard Deviation|Mean
2739906|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)|hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L).|Week 24|ITT population|||percent change in mg/L||Standard Deviation|Mean
2739907|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in HAQ-DI|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Week 24|ITT population|||percent change from baseline||Standard Deviation|Mean
2739908|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity|"The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme was considered maximum disease activity. The physician's global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded."|Week 24|ITT population|||percent change in mm||Standard Deviation|Mean
2739909|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity|"The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme as maximum disease activity (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded."|Week 24|ITT population|||percent change in mm||Standard Deviation|Mean
2739910|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain|"The participant's assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as no pain and the right-hand as unbearable pain. The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded."|Week 24|ITT population|||percent change in mm||Standard Deviation|Mean
2739911|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in SJC|Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population|||percent change in swollen joints||Standard Deviation|Mean
2739912|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in TJC|Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population|||percent change in tender joints||Standard Deviation|Mean
2739913|NCT00951275|Primary|Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.|Week 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2739943|NCT00951041|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 0 and Day 21.|||Participants|||Count of Participants
2739914|NCT00951275|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement|The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]).|Week 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
2739915|NCT00951275|Secondary|Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2739916|NCT00951275|Secondary|FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline, Weeks 2, 4, 8,12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2739917|NCT00951275|Secondary|Improvement of Anemia Assessed as Change From Baseline in Hemoglobin|Improvement of anemia was evaluated as change in hemoglobin levels from baseline.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
2739918|NCT00951275|Primary|Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin|Hemoglobin levels were measured as grams/deciliter (g/dL).|Week 4|ITT population|||g/dL||Standard Deviation|Mean
2739919|NCT00951275|Secondary|Mean Hemoglobin Levels During the Study||Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
2739920|NCT00951171|Secondary|Positive Pregnancy Test||14 days|||||||
2739921|NCT00951171|Secondary|Live Birth||9 months|||||||
2739922|NCT00951171|Primary|Clinical Pregnancy|positive beta HCG test|1 month|All study women undergoing IUI were included|||positive pregnancy test (beta HCG)|||Number
2739923|NCT00951093|Primary|Number of Participants With Increased Acid Exposure|Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
2739924|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Supine Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position|Before GBP, 6 months after GBP and 39 months after GBP||||percentage of time||Inter-Quartile Range|Median
2739925|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Upright Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position|Before GBP, 6 months after GBP and 39 months after GBP||||percentage of time||Inter-Quartile Range|Median
2739926|NCT00951093|Primary|Total Esophageal Acid Exposure at 24h pH Monitoring|Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.|Before GBP, 6 months after GBP and 39 months after GBP||||percentage of time||Inter-Quartile Range|Median
2739927|NCT00951093|Primary|Number of Participants With Gastroesophageal Reflux Disease (GERD)|Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
2739928|NCT00951093|Primary|Number of Participants With Esophageal Injury|Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
2739929|NCT00951093|Primary|Number of Participants Presenting Reflux Symptoms|"Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.~In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used."|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
2739930|NCT00951041|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESI)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (From Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2739931|NCT00951041|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2739932|NCT00951041|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up after the first vaccination and during the 63-day (Days 21-83) follow-up after the second vaccination (From Day 0 to Day 84)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2739933|NCT00951041|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) follow-up period after each dose and overall|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2739934|NCT00951041|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 fever = fever above (>) 40.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2739935|NCT00951041|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) follow-up period after each dose and overall|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
2739936|NCT00951041|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2739937|NCT00951041|Secondary|SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 364|The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.|||Fold change||95% Confidence Interval|Geometric Mean
2739938|NCT00951041|Secondary|SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 182|The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.|||Fold change||95% Confidence Interval|Geometric Mean
2739939|NCT00951041|Secondary|SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 35|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2739940|NCT00951041|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 21.|||Fold change||95% Confidence Interval|Geometric Mean
2739941|NCT00951041|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 364|The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.|||Participants|||Count of Participants
2739942|NCT00951041|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 182|The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.|||Participants|||Count of Participants
2739954|NCT00951015|Other Pre-specified|Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points|Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population||||||
2739944|NCT00951041|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 364|The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.|||Participants|||Count of Participants
2739945|NCT00951041|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 182|The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.|||Participants|||Count of Participants
2739946|NCT00951041|Secondary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 21.|||Participants|||Count of Participants
2739947|NCT00951041|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 364|The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
2739948|NCT00951041|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Day 182|The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2739949|NCT00951041|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood samples taken at Day 0 and Day 21.|||Titers||95% Confidence Interval|Geometric Mean
2739950|NCT00951041|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.|At Day 35|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.|||Fold change||95% Confidence Interval|Geometric Mean
2739951|NCT00951041|Primary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.|At Day 35|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.|||Participants|||Count of Participants
2739952|NCT00951041|Primary|Number of Seroconverted Subjects for HI Antibodies|Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.|At Day 35|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.|||Participants|||Count of Participants
2739953|NCT00951041|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.|At Day 35|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2739980|NCT00950963|Secondary|Number of CVD Patients With LDL Less Than 70 mg/dL.||18 months|Analysis was per intention to treat|||Participants|||Number
2739955|NCT00951015|Secondary|Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters|Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).Only those participants available at the specified time points were analyzed represented by n=X in the category titles|Week 96|PK/PD Analysis Population.|||estimated effect|||Number
2739956|NCT00951015|Secondary|Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.|Week 96|PK/PD Analysis Population.Only those participants available at the specified time points were analyzed|||Pearson's correlation coefficient|||Number
2739957|NCT00951015|Secondary|Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Week 96|PK/PD Analysis Population.|||Pearson's correlation coefficient|||Number
2739958|NCT00951015|Secondary|Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters|Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures|Week 2|PK/PD Analysis Population.Only those participants available at the specified time points were analyzed.|||Pearson's correlation coefficient|||Number
2739959|NCT00951015|Secondary|Time to Maximal Drug Concentration (Tmax) of DTG|Tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.|||Hours||Full Range|Median
2739960|NCT00951015|Secondary|Pre-dose Concentration (C0) and C0 Avg of DTG|The plasma DTG C0 of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.|Week 2, Week 12, and Week 24|PK Summary Population.|||Microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2739961|NCT00951015|Secondary|Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG|The Cmax, Cmax, and Ctau of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2739962|NCT00951015|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed.|Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population.|||Hours*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2766112|NCT00765388|Secondary|Immediate Adhesion|Evaluation of immediate adhesion after each period|4 weeks|Intention to treat (ITT)|||Participants|||Number
2739963|NCT00951015|Secondary|Plasma DTG Concentration|Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.|Week 2, Week 12, and Week 24|PK Summary Population.|||Micrograms per milliliter (µg/mL)||Standard Deviation|Mean
2739964|NCT00951015|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data|From Baseline up to Week 96/Early Withdrawal|On-treatment Phenotypic Resistance Population|||Participants|||Number
2739965|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population|||Participants|||Number
2739966|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population.|||Participants|||Number
2739967|NCT00951015|Secondary|Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities|Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From Baseline up to Week 96/Early Withdrawal|Safety Population|||Participants|||Number
2739968|NCT00951015|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From Baseline up to Week 96/Early Withdrawal|Safety Population:All participants who received at least one dose of the study medication|||Participants|||Number
2739969|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population|||Participants|||Number
2739981|NCT00950963|Primary|Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL|Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study|18 months|Analysis was per intention to treat.|||Participants|||Number
2739970|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population|||Participants|||Number
2739971|NCT00951015|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.|From Baseline up to Week 96|ITT-E Population|||Participants|||Number
2739972|NCT00951015|Secondary|Number of Participants With New HIV-associated Conditions of the Indicated Class|HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.|From Baseline up to Week 96|ITT-E Population|||Participants|||Number
2739973|NCT00951015|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population.|||Cells per cubic millimeter||Inter-Quartile Range|Median
2739974|NCT00951015|Secondary|Change From Baseline in HIV-1 RNA at the Indicated Time Points|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Log10 c/mL||Standard Deviation|Mean
2739975|NCT00951015|Secondary|Viral Change Over the Initial 2 Weeks of Treatment|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline. Only those participants available at the specified time point were analyzed.|Baseline and Week 2|ITT-E Population.|||Log10 c/mL||Standard Deviation|Mean
2739976|NCT00951015|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16|Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication|Week 16|ITT-E Population|||participants|||Number
2739977|NCT00950963|Secondary|Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study|Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.|18 months||||Participants|||Number
2739978|NCT00950963|Secondary|Number of Patients With BP Less Than 130/80 mm Hg|Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.|18 months|Analysis per intention to treat|||participants|||Number
2739979|NCT00950963|Other Pre-specified|Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.|Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations|18 months|Analysis per intention to treat|||Number of ED visits and hospitalizations|||Number
2739984|NCT00950950|Secondary|Apparent Clearance (CL/F) of Romosozumab|Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.|Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||mL/day/kg||Standard Deviation|Mean
2739985|NCT00950950|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf)|Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.|Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||μg*day/mL||Standard Deviation|Mean
2739986|NCT00950950|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28)|"Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.~The area under the serum drug concentration-time curve from time zero to tau (tau = 28 days) (AUC0-28) was calculated by the linear trapezoidal method."|First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||μg*day/mL||Standard Deviation|Mean
2739987|NCT00950950|Secondary|Maximum Serum Concentration (Cmax) of Romosozumab|Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.|First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||μg/mL||Standard Deviation|Mean
2739988|NCT00950950|Secondary|Time to Maximum Serum Concentration (Tmax) of Romosozumab|Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.|First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169|All participants who received romosozumab and for whom the pharmacokinetic parameter could be calculated|||days||Full Range|Median
2739989|NCT00950950|Secondary|Percent Change From Baseline in Serum C-Telopeptide (sCTX)||Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739990|NCT00950950|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)||Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739991|NCT00950950|Secondary|Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine|Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.|Baseline and days 85 and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739992|NCT00950950|Secondary|Percent Change From Baseline in Bone Mineral Density at the Total Wrist|Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739993|NCT00950950|Secondary|Percent Change From Baseline in Bone Mineral Density at the One-third Radius|Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739994|NCT00950950|Secondary|Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius|The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739995|NCT00950950|Secondary|Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius|Trabecular bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739996|NCT00950950|Secondary|Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius|Trabecular bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739997|NCT00950950|Secondary|Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius|Trabecular bone area was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739998|NCT00950950|Secondary|Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius|Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2739999|NCT00950950|Secondary|Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius|Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740014|NCT00950937|Secondary|Peak Oxygen Uptake|Is the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.|1 time, before the exercise protocol||||ml/min||Standard Deviation|Median
2740000|NCT00950950|Secondary|Percent Change From Baseline in Total Bone Area at the Ultradistal Radius|Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740001|NCT00950950|Secondary|Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius|Axial moment of inertia is an indicator of the ability of bone to resist bending, and was derived from pQCT measurements based on a circular ring model. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740002|NCT00950950|Secondary|Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius|The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740003|NCT00950950|Secondary|Percent Change From Baseline in Polar Section Modulus at the Distal Radius|Polar section modulus is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740004|NCT00950950|Secondary|Percent Change From Baseline in Cortical Thickness at the Distal Radius|Cortical thickness was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740005|NCT00950950|Secondary|Percent Change From Baseline in Periosteal Circumference at the Distal Radius|Periosteal circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740006|NCT00950950|Secondary|Percent Change From Baseline in Endocortical Circumference at the Distal Radius|Endocortical circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740007|NCT00950950|Secondary|Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius|Cortical bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740008|NCT00950950|Secondary|Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius|Cortical bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740009|NCT00950950|Secondary|Percent Change From Baseline in Cortical Bone Area at the Distal Radius|Cortical bone area was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740010|NCT00950950|Secondary|Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius|Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740011|NCT00950950|Secondary|Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius|Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740012|NCT00950950|Secondary|Percent Change From Baseline in Total Bone Area at the Distal Radius|Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740013|NCT00950950|Primary|Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius|The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.|Baseline and days 29, 57, 85, 127, and 169|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2740016|NCT00950937|Secondary|T CD4|T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||Cell/ul of blood||Inter-Quartile Range|Median
2740017|NCT00950937|Secondary|Lipid Peroxidation|Thiobarbituric acid-reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||picomol of TBARS/mg protein||Inter-Quartile Range|Median
2740018|NCT00950937|Secondary|Glutathione S-transferase (GST)|Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||micromol of GST/min/mg of protein||Inter-Quartile Range|Median
2740019|NCT00950937|Primary|Total Glutathione|The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||nmoles glutathione/ ml of sample||Inter-Quartile Range|Median
2740020|NCT00950937|Secondary|Catalase Activity|Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||units of catalase /mg protein||Inter-Quartile Range|Median
2740021|NCT00950911|Primary|Number of Participants Survived||2 years|Full Analysis Set|||Participants|||Number
2740022|NCT00950872|Secondary|Incidence of Stapler 'Misfires'|The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||participants|||Number
2740023|NCT00950872|Secondary|Length of Hospital Stay|Days spent in the hospital|Day 2 (Approximately 1.5 days post randomization)|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||days||Standard Deviation|Mean
2740024|NCT00950872|Secondary|Operating Room (OR) Time|OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||minutes||Standard Deviation|Mean
2740025|NCT00950872|Primary|Incidence of Adverse Events.||Day 30|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||adverse events|||Number
2740026|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 hematological toxicities included: Hemoglobin, Platelet Count, Total Neutrophils, and White Blood Cell count.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG|||Participants|||Number
2740027|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG|||Participants|||Number
2740028|NCT00950859|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log 10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log 10 c/mL unless <400 c/mL or an increase of >=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|PDVF Phenotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time of PDVF failure. Only participants with both Baseline and PDVF time-point DTG phenotypic data were considered for analysis.|||Participants|||Number
2740106|NCT00950690|Primary|Intraocular Pressure|Intraocular pressure was measured at each visit|Screening, 10 days, 4 weeks and 12 weeks after beginning treatment|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.|||millimeters of mercury||Standard Deviation|Mean
2740029|NCT00950859|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|On-treatment Genotypic Resistance Population: all ITT-E participants who met the criteria for protocol-defined virological failure (PDVF)|||Participants|||Number
2740030|NCT00950859|Secondary|Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group|Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.|Baseline (Day 1)|ITT-E Population|||Percentage||Full Range|Median
2740031|NCT00950859|Secondary|Number of Participants With the Indicated Genotypic Resistance at Baseline|At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.|Baseline|ITT-E Population|||Participants|||Number
2740032|NCT00950859|Secondary|Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion|PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population|||Participants|||Number
2740033|NCT00950859|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population.|||Participants|||Number
2740034|NCT00950859|Secondary|Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences|The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.|||Participants|||Number
2740035|NCT00950859|Secondary|AUC0-24 Assessment of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2740036|NCT00950859|Secondary|Tmax of DTG|The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population|||Hours||Full Range|Median
2740037|NCT00950859|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).|Day 10; Weeks 4 and 24|PK Parameter Population|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2740038|NCT00950859|Secondary|Cmax, Cmin, and Ctau of DTG|The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|Pharmacokinetic (PK) Parameter Population: all participants who provided at least one evaluable PK concentration|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2740039|NCT00950859|Secondary|Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion|Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X in the category titles).|||cells per cubic millimeter (mm^3)||Full Range|Median
2740040|NCT00950859|Secondary|Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion|ITT-E Population|||Percentage of Participants|||Number
2740041|NCT00950859|Secondary|Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline; Weeks 4, 12, 24, 48, 72, and 96|ITT-E Population|||Participants|||Number
2740042|NCT00950859|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion|Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).|||Log10 copies/mL||Standard Deviation|Mean
2740043|NCT00950859|Primary|Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11|The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.|Baseline (Day 1) and Day 11|Intent-to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline measure of plasma HIV-1 RNA.|||Participants|||Number
2740044|NCT00950833|Secondary|Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs|The number of subjects with new acquisition of H. influenzae detected in nasopharyngeal swabs was recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
2740045|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs|The number of subjects with new acquisition of S. pneumoniae (non-vaccine and non-cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
2740046|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs|The number of subjects with new acquisition of S. pneumoniae (cross-reactive serotypes) detected in nasopharyngeal swabs was recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
2740047|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs|The number of subjects with new acquisition of S. pneumoniae (Synflorix™ vaccine serotypes) detected in nasopharyngeal swabs was recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
2740048|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With Haemophilus Influenzae|Positive cultures of H. influenzae identified in the nasopharynx were recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs associated to specified bacteria|||Number
2744171|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
2740049|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)|Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs associated to specified bacteria|||Number
2740050|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)|Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs associated to specified bacteria|||Number
2740051|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)|Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs associated to specified bacteria|||Number
2740052|NCT00950833|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 10 or Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2740053|NCT00950833|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2740054|NCT00950833|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2740055|NCT00950833|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2740056|NCT00950833|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2740057|NCT00950833|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2740058|NCT00950833|Secondary|Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)|The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.|At 25-36 months post-vaccination in previous 107137 (NCT00496015) study|The analysis was performed on the ATP cohort for antibody persistence, which included all subjects with the vaccine administration documented, for whom assay results were available for antibodies against each considered antigen for the blood sample taken before the administration of Synflorix™ vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2740059|NCT00950833|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2740060|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2740061|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A|The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2740062|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2740063|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2740064|NCT00950833|Secondary|Memory B-cell Detection for Vaccine Polysaccharides (PS)|B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Memory B-cells||Standard Deviation|Mean
2740065|NCT00950833|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2740066|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2740067|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A|The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2740068|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2740069|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.|Prior to the first study vaccine dose (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2740070|NCT00950833|Primary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|At 7-10 days after the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2740071|NCT00950807|Secondary|Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period|Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.|||Liters||Standard Deviation|Mean
2740072|NCT00950807|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP; mean BL is the mean of the BLs for each participant and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 14.|||Liters||Standard Error|Least Squares Mean
2740073|NCT00950807|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Baseline and Day 15 of each treatment period (up to Study Day 71)|Modified Intent-To-Treat (mITT) Population: all participants randomized to treatment who received at least one dose of study medication. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.|||Liters||Standard Error|Least Squares Mean
2740074|NCT00950755|Secondary|Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose|Hypothyroidism is a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants experiencing hypothyroidism were analyzed.|||days|||Number
2740075|NCT00950755|Secondary|Number of Participants in the Indicated Categories of Thyroid Function Assessment|Hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood), may result from treatment with radioactive iodine I 131. A thyroid blockade medication was given prior to administration of the study drug and up to 2 weeks after the therapeutic dose to prevent the uptake of I 131 in the thyroid gland. Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the I 131 on thyroid function, such as hypothyroidism.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who were evaluable for thyroid function assessment and who had no elevated TSH level or hypothyroidism at baseline were analyzed.|||participants|||Number
2740076|NCT00950755|Secondary|Time to HAMA Positivity From First Dosimetric Dose|Time to HAMA positivity is defined as the time from the first dosimetric dose to the first reported HAMA-positive result for the participant.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.|||days||Full Range|Median
2740077|NCT00950755|Secondary|Number of Participants Who Became Positive or Negative for Human Anti-murine Antibody (HAMA) After Study Treatment|Tositumomab is a murine (mouse) antibody. Participants in this study were evaluated to determine if they developed a human anti-murine antibody (HAMA) immune response after administration of tositumomab and iodine I 131 tositumomab.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2740078|NCT00950755|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).|||g/dL||Full Range|Median
2740079|NCT00950755|Secondary|Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).|||1000 cells/millimeters cubed (mm^3)||Full Range|Median
2740080|NCT00950755|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to nadir and time to recovery to baseline. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).|||days||Full Range|Median
2740081|NCT00950755|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|"ITT Exposed Population. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."|||days||Full Range|Median
2740082|NCT00950755|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.|||participants|||Number
2740083|NCT00950755|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2740084|NCT00950755|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. All participants who experienced any SAE were analyzed.|||participants|||Number
2740107|NCT00950664|Other Pre-specified|Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline|Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.|4, 8, 12 and 16 weeks after injection||||units on a scale||Standard Deviation|Mean
2740108|NCT00950664|Other Pre-specified|Reduction of Total TWSTRS at Each Visit From Baseline|TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.|8, 12 and 16 weeks after injection||||units on a scale||Standard Deviation|Mean
2740085|NCT00950755|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2740086|NCT00950755|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
2740087|NCT00950755|Secondary|Time to Treatment Failure as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced treatment failure were evaluated.|||months||95% Confidence Interval|Median
2740088|NCT00950755|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. New lesions must be greater than 2 x 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced progression were evaluated.|||months||95% Confidence Interval|Median
2740089|NCT00950755|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2740090|NCT00950755|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.|||participants|||Number
2740091|NCT00950755|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >4 weeks apart. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease (EOD) must be unchanged or decreased upon follow-up evaluations. If the EOD was unchanged or if further decreases occurred for >=6 months, the participant was reclassified as having a CR.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.|||participants|||Number
2740092|NCT00950755|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2740109|NCT00950664|Secondary|PGI-I (Patient's Global Impression of Improvement)|"The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)~1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated"|4, 8, 12 and 16 weeks after injection||||percentage of patients scoring 1 or 2|||Number
2740110|NCT00950664|Secondary|CGI-I (Clinical Global Impression of Illness)|"The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I)~1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'."|4, 8, 12 and 16 weeks after injection||||percentage of participants scoring 1or2|||Number
2740093|NCT00950755|Primary|Number of Participants With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2740094|NCT00950755|Primary|Number of Participants (Par.) With Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.|||participants|||Number
2740095|NCT00950742|Secondary|Summary of Concentration of Herceptin in Plasma|Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740096|NCT00950742|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||hours||Full Range|Median
2740097|NCT00950742|Secondary|Summary of Concentration of Afatinib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740098|NCT00950742|Secondary|Progression Free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.|Baseline until disease progression, death or data cut-off.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Days||95% Confidence Interval|Median
2740099|NCT00950742|Secondary|Number of Patients With Best Overall Response|Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
2740100|NCT00950742|Secondary|Number of Patients With Objective Response (OR)|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
2740101|NCT00950742|Primary|Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)|The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.|28 days|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.|||mg|||Number
2740102|NCT00950742|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.|28 days|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.|||Participants|||Number
2740103|NCT00950729|Primary|Mean Breaking Force Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking force during emergency braking with and without distractor|June 2007 to September 2007||||pounds||Standard Deviation|Mean
2740104|NCT00950729|Primary|Mean Breaking Time Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.|June 2007 to September 2007||||seconds||Standard Deviation|Mean
2740105|NCT00950690|Primary|Humphrey Perimetry Visual Field|Analysis of visual field deficits for abnormalities.|Visits 1 and 4|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.|||decibels||Standard Deviation|Mean
2744172|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
2740112|NCT00950664|Secondary|Reduction of Total TWSTRS Score at 4 Weeks From Baseline|"TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD).~The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain.~(range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS."|4 weeks after injection from baseline||||units on a scale||Standard Deviation|Mean
2740113|NCT00950664|Primary|Reduction of Total Tsui Score at 4 Weeks From Baseline|"Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor.~Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale."|4 weeks after injection from baseline||||units on a scale||Standard Deviation|Mean
2740114|NCT00950651|Secondary|Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty with stairs with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
2740115|NCT00950651|Secondary|Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty walking with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
2740116|NCT00950651|Secondary|Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their ability to get things done with their worst knee using a five-point scale ranging from: 1=No problem to 5=A lot of things didn't get done. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
2740117|NCT00950651|Secondary|Patient Diary: Stiffness (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the stiffness in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
2740118|NCT00950651|Secondary|Patient Diary: Pain (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the arthritis pain in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
2740119|NCT00950651|Secondary|Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12|The physician was asked to indicate the effectiveness of pain control 24 hours after the most recent dose of tramadol using a 4-point Likert-scale, dichotomized for the analysis: Very Effective, Effective, Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740120|NCT00950651|Secondary|Physician Overall Rating: Overall Assessment at Week 12|The physician was asked to indicate his overall assessment of the formulation the patient was taking using a 4-point Likert-scale dichotomized for the analysis: Very Effective, Effective, and Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740121|NCT00950651|Secondary|Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12|"Patients who have previously taken tramadol HCl were asked: Compared to when you were previously taking tramadol, how have any side effects you have felt during this study interfered with your day-to-day activities?. Possible answers were: Interfered much less now, Interfered somewhat less now, Same as before, Interfered more now."|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740734|NCT00946023|Secondary|Incidence of Grades III-IV Acute GVHD|Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
2740122|NCT00950651|Secondary|Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12|"Patients who have previously taken tramadol HCl were asked to compare how they compare the current pain relief to the pain relief felt when previously taking tramadol, using a 4-point Likert-scale: Worse than before, Same as before, Somewhat better now, or Much better now."|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740123|NCT00950651|Secondary|Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12|"Patients were asked: How have any side effects you may have felt from the drug interfered with day-to-day activities? with 4 possible answers: Significantly, Somewhat, Minimally, Not at all."|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740124|NCT00950651|Secondary|Patient Global Rating of Pain Relief at Week 12|"The Patient Global Rating of Pain is a Likert-scale that answers the question: How do you rate overall pain relief with the drug? with 4 possible answers that were dichotomized: very effective, effective, and somewhat effective were summarized to effective; not effective remained unchanged."|12 Weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740125|NCT00950651|Secondary|Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12|The walking test is a measure of how many seconds it takes the patient to walk a distance of 15 meters. The change from baseline to week 12 was calculated.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740126|NCT00950651|Secondary|Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12|Patients indicated their Average Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740127|NCT00950651|Secondary|Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12|Patients indicated their Worst Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740128|NCT00950651|Secondary|Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12|Patients indicated their Least Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740129|NCT00950651|Secondary|Percentage of Change From Baseline in Current Pain at Week 12|Pain Visual Analogue Scales: Current Pain. Patients indicated their current pain using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change in current pain was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740130|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Total Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Each item is rated on a 100mm VAS scale (0mm=no pain/stiffness/difficulty to 100mm=extreme no pain/stiffness/difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740233|NCT00950599|Primary|Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percentage of glycosylated hemoglobins||Standard Error|Mean
2740131|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Physical Function subscale score consists of 17 items rated on a 100mm VAS scale (0mm=no difficulty to 100mm=extreme difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740132|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Stiffness subscale score consists of 2 items each rated on 100mm VAS scale (0mm=no stiffness to 100mm=extreme stiffness). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740133|NCT00950651|Secondary|Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)|Each day before morning dose, patients assessed arthritis pain in worst knee in a diary using a 5-point rating scale ranging from none to severe. A median score was estimated for each patient each week and re-categorized into different degrees of pain (rounding off to the closest integer). Results are of 12th week (day 78-84).|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
2740134|NCT00950651|Primary|Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
2740135|NCT00950612|Secondary|Anti-M72 Specific Antibody Concentrations|Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2740136|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2740137|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2740138|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2740139|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2740255|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population|||participants|||Number
2740140|NCT00950612|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2740141|NCT00950612|Primary|Number of Subjects With Haematological Levels Below Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740142|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Below Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740143|NCT00950612|Primary|Number of Subjects With Haematological Levels Above Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740144|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Above Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740145|NCT00950612|Primary|Number of Subjects With Normal Haematological Levels|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were - normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740146|NCT00950612|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performedon the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740147|NCT00950612|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740148|NCT00950612|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740149|NCT00950612|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740150|NCT00950612|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2740184|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740151|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.|||Percentage of participants|||Number
2740152|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.|||Percentage of participants|||Number
2740153|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.|||Percentage of participants|||Number
2740154|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.|||Percentage of participants|||Number
2740155|NCT00950599|Secondary|Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control|Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)|Week 4, Week 6|||||||
2740156|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6|||||||
2740157|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||||||
2740158|NCT00950599|Secondary|Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort|Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.|Week 6|Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.|||Percentage of Participants|||Number
2740159|NCT00950599|Secondary|Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort|Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Deviation|Mean
2740160|NCT00950599|Secondary|Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Deviation|Mean
2740161|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percent||Standard Deviation|Mean
2740162|NCT00950599|Secondary|Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)|||umol/L||Standard Deviation|Mean
2740163|NCT00950599|Secondary|Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).|||umol/L||Standard Deviation|Mean
2740164|NCT00950599|Secondary|Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)|||mg/dL||Standard Deviation|Mean
2740165|NCT00950599|Secondary|Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).|||mg/dL||Standard Deviation|Mean
2740166|NCT00950599|Secondary|Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)|||percentage of glycated hemoglobins||Standard Deviation|Mean
2740167|NCT00950599|Secondary|Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).|||percentage of glycated hemoglobins||Standard Deviation|Mean
2740168|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2740169|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2740170|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2740171|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2740172|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2740173|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2740174|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEq/mL||Standard Error|Mean
2740175|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEq/mL||Standard Error|Mean
2740176|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
2740177|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
2740178|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEg/L||Standard Error|Mean
2740179|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEg/L||Standard Error|Mean
2740180|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
2740181|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
2740182|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740183|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2766863|NCT00762034|Secondary|Number of Participants Receiving Concomitant Medication||Baseline to study endpoint (up to 37.06 months)|All randomized participants|||participants|||Number
2740185|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740186|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740187|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740188|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740189|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740190|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740191|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740192|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740193|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740194|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740195|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740196|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2744173|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
2740197|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740198|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740199|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740200|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740201|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740202|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740203|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740204|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740205|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740206|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740207|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740208|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740209|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740210|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740211|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740212|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740213|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740214|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740215|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740216|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740217|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740218|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng*min/mL||Standard Error|Mean
2740219|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng*min/mL||Standard Error|Mean
2740220|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU*min/mL||Standard Error|Mean
2740295|NCT00949988|Secondary|To Evaluate in CLL Cells Pharmacodynamic (PD) Parameters Including the Following: in Vivo Signal Transduction Events, Levels of Cellular Apoptosis and Regulation of Apoptosis Related Genes and Proteins.||2 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2740221|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU*min/mL||Standard Error|Mean
2740222|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg*min/dL||Standard Error|Mean
2740223|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg*min/dL||Standard Error|Mean
2740224|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740225|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
2740226|NCT00950599|Secondary|Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740227|NCT00950599|Secondary|Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
2740228|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||umol/L||Standard Error|Mean
2740229|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||umol/L||Standard Error|Mean
2740230|NCT00950599|Secondary|Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740231|NCT00950599|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2740232|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percentage of glycosylated hemoglobins||Standard Error|Mean
2740296|NCT00949988|Secondary|To Determine the Effect of Several Prognostic Factors Including CD38 Expression, ZAP-70 Expression, Immunoglobulin Variable Heavy Chain (VH) Gene Mutation Status and Cytogenetic/FISH Profile on Treatment Response.||2 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2740234|NCT00950599|Primary|Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort|Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.|Baseline, Week 12|Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percentage of glycosylated hemoglobins||Standard Deviation|Mean
2740235|NCT00950352|Secondary|Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.|Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.|Throughout the course of the study|||||||
2740236|NCT00950352|Secondary|Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.|Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.|Neuroimaging will occur at week 0 and week 8/9|||||||
2740237|NCT00950352|Secondary|Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.|Cognitive measurement tests will be employed.|Neuropsychological testing will occur at week 0 and week 8/9|||||||
2740238|NCT00950352|Primary|Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo|Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.|8 weeks, assessed twice weekly starting week1||||total amount consumed in grams||Standard Deviation|Mean
2740239|NCT00950300|Secondary|Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)|"Participants in the Herceptin SC arm provided PK samples for evaluation of anti-rHuPH20 antibodies. The number of participants with Treatment-induced ADAs and Treatment-enhanced ADA against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer)."|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18|Safety Population; as rHuPH20 is unique to SC formulation, this outcome measure was applicable for “Herceptin SC + Chemotherapy” arm only. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2740240|NCT00950300|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab|"Participants provided PK samples for evaluation of anti-trastuzumab antibodies. The number of participants with Treatment-induced ADAs and Treatment-enhanced ADA against trastuzumab at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer)."|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18|Safety Population: All participants who received at least one dose of study medication. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2740241|NCT00950300|Secondary|Overall Survival (OS)|OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||months||Full Range|Median
2740242|NCT00950300|Secondary|Percentage of Participants Who Died|The percentage of participants who died at any time during the study was reported.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||percentage of participants|||Number
2740243|NCT00950300|Secondary|Event-Free Survival (EFS)|Protocol-defined events included disease recurrence or progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||months||Full Range|Median
2740244|NCT00950300|Secondary|Percentage of Participants Who Experienced a Protocol-Defined Event|Protocol-defined events included disease recurrence/progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. The percentage of participants who experienced a protocol-defined event at any time during the study was reported.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||percentage of participants|||Number
2740256|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab After Surgery|Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|PKPP Population; only participants with a Cycle 13 pre-dose PK measurement were included in the analysis.|||μg/mL||Standard Deviation|Mean
2740297|NCT00949988|Secondary|To Assess Minimal Residual Disease (MRD) by Flow Cytometry||2 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2740245|NCT00950300|Secondary|Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm with no prior assessment of PD. PR was defined as ≥30% decrease from Baseline in SD of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. Time to response was defined as the time from first dose of study medication to the first assessment of CR or PR, which was the date the response was first documented by objective evidence, among participants with an overall response of CR or PR.|Tumor assessments at Baseline; on Day 1 Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline and a response of CR or PR were included.|||weeks||Full Range|Median
2740246|NCT00950300|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter (SD) of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline were included.|||percentage of participants||95% Confidence Interval|Number
2740247|NCT00950300|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|EPP Population|||percentage of participants||95% Confidence Interval|Number
2740248|NCT00950300|Secondary|AUC21d of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 12 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in d*μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.|||d*μg/mL||Standard Deviation|Mean
2740249|NCT00950300|Secondary|Tmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Tmax during Cycle 12 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.|||days||Standard Deviation|Mean
2740250|NCT00950300|Secondary|Cmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Cmax during Cycle 12 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.|||μg/mL||Standard Deviation|Mean
2740251|NCT00950300|Secondary|Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 7 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in days multiplied by micrograms per milliliters (d*μg/mL).|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.|||d*μg/mL||Standard Deviation|Mean
2740252|NCT00950300|Secondary|Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Tmax during Cycle 7 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.|||days||Standard Deviation|Mean
2740253|NCT00950300|Secondary|Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Cmax during Cycle 7 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.|||μg/mL||Standard Deviation|Mean
2740254|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population|||participants|||Number
2740280|NCT00950170|Secondary|Mean of Total Number of Days Participants Exposed to Study Drug||2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Days||Standard Deviation|Mean
2740257|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab Prior to Surgery|Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|PKPP Population: All participants with at least one measurable trastuzumab serum concentration.|||μg/mL||Standard Deviation|Mean
2740258|NCT00950300|Secondary|Observed Ctrough of Trastuzumab After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary endpoint.|||μg/mL||Standard Deviation|Mean
2740259|NCT00950300|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.|||percentage of participants||95% Confidence Interval|Number
2740260|NCT00950300|Primary|Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.|||μg/mL||Standard Deviation|Mean
2740261|NCT00950248|Secondary|Change in Slopes of EDSS From Baseline to Treatment Phase|EDSS scale combines various elements of neurological exam. EDSS is a discrete scale ranging from 0 to 10 with 0.5 point increments. EDSS of 0 means no neurological disability, while EDSS of 10 marks death due to MS. EDSS was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase.The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.|1-year pre-treatment baseline vs 2-year treatment period|The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.|||units on a scale per year||Standard Error|Mean
2740262|NCT00950248|Secondary|Change in Slopes of SNRS From Baseline to Treatment Phase on|SNRS scale combines various elements of a neurological exam into a single number. The scale ranges from 100 to 0, where 100 marks no disability and 0 marks maximum disability. SNRS was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.|1-year pre-treatment baseline vs 2-year treatment period|The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.|||units on a scale per year||Standard Error|Mean
2740263|NCT00950248|Secondary|Change in Slopes of 9HPT Time From Baseline to Treatment Phase|"Upper extremity/fine motor movements disability was measured as an average of left and right hand time, with each hand assessed as an average of two trials with upper limit of 5 (300s) per trial. Patients unable to complete the task within this time are coded as 777 The outcome was assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0."|1-year pre-treatment baseline vs 2-year treatment period|The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.|||seconds per year||Standard Error|Mean
2740264|NCT00950248|Secondary|Change in Slopes of 25FW Time From Baseline to Treatment Phase|"Lower extremity disability was measured by an average of two trials of timed 25 foot walk assessed at month -12, -6, and 0 for the baseline phase and at month 0, 6, 12, 18, and 24 for the treatment phase. The progression rate was calculated as a difference between baseline and treatment slopes using a piecewise linear mixed-effect model with breaking point at month 0.~The maximum time assigned for a trial is 180s. Patients unable to complete the 25 foot trial within this time limit are coded as 179.9"|1-year pre-treatment baseline vs 2-year treatment period|The piecewise mixed-effect model only considers patient that completed all follow-up visits, therefore the Completer population (33 patients in placebo and 33 patients in the idebenone group) was considered for this analysis.|||seconds per year||Standard Error|Mean
2740265|NCT00950248|Secondary|Disability Progression Measured by EDSS-plus|"Categorical time-to-event endpoints (EDSS-plus) were analyzed using Cox Proportional hazards models, with treatment group as a covariate. The EDSS-plus event was defined as disability progression on at least 1 of 3 components [EDSS, 25FW, and/or non-dominant hand 9HPT]) confirmed 6 months apart and with a ≥ 20% minimum threshold change for 25FW and non-dominant hand 9HPT).~The patients who did not have an event during the study were censored at the time of the last assessment of EDSS-plus. The number of months from the date of first dose to date of event or censoring were used as endpoint. The measure is time to disease progression and unit of this measure is months."|2-year treatment period|The outcome was assessed in the Intention-to-treat population of patients: all randomized patients who have at least one post-baseline (post Mo 0) efficacy assessment. 38 out of 39 patients randomized to idebenone and 35 out of 38 patients randomized to placebo fulfill this definition.|||months||95% Confidence Interval|Median
2740281|NCT00950170|Secondary|Mean of Total Number of Infusions of Study Drug Received||2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Infusions||Standard Deviation|Mean
2773008|NCT00719329|Primary|Colonization at Day 3 Swab|Were any organisms found on the swab collected on at Day 03|First Week of Life|Intent to Treat|||Participants|||Number
2740266|NCT00950248|Secondary|Change in the AUC of Individualized Rates of Enlargement of Ventricular Volume From Baseline to Treatment Phase|"The AUCs of the Ventricular volume scores (individualized rates of enlargement of segmented volume of lateral and 3rd ventricles) during the baseline and the 2-year treatment period were assessed using an ANCOVA model with the AUC of the pre-treatment Volumetric score, Baseline (Month 0) Volumetric score, and group as covariates.~The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18 and 24).~Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases."|1-year pre-treatment baseline vs 2-year treatment period|The primary outcome was assessed in Intention-to-treat population. Due to technical error in MRI images processing 2 out of 38 idebenone patients were excluded from the analysis.|||ml per year||Standard Deviation|Mean
2740267|NCT00950248|Primary|Change in the Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE) From Baseline to Treatment Phase|"The AUCs of the CombiWISE scores during the 2-year treatment period was analyzed using an Analysis of Covariance (ANCOVA) model with the AUC of the pre-treatment CombiWISE scores, Baseline (Month 0) CombiWISE score and Baseline age as covariates.~CombiWISE is a composite scale derived from Expanded Disability Status Scale (EDSS) , Scripps Neurological Disability Scale (SNRS), times 25 foot walk (25FW), and non-dominant hand of 9 hole peg test (9HPT) with a minimum value of 0 (no disability) and maximum value of 100 (maximum disability).~The AUC values were calculated for both the pre-treatment baseline phase (from Months -12, -6, and 0) and for the double-blind phase (from Months 0, 6, 12, 18, and 24).~Because the follow-up times varied from patient to patient, the AUC values were made comparable by scaling them by dividing the AUC value by the square of the actual duration (in years) of each of the phases."|1-year pre-treatment baseline vs 2-year treatment period|The primary outcome was assessed in Intention-to-treat population of patients: all randomized patients who have at least one post-baseline (post Mo 0) efficacy assessment. 38 out of 39 patients randomized to idebenone and 35 out of 38 patients randomized to placebo fulfill this definition.|||units on a scale per year||Standard Deviation|Mean
2740268|NCT00950235|Secondary|Large for Gestational Age (LGA)|Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.|At birth|Babies born to participants|||participants|||Number
2740269|NCT00950235|Secondary|Pregnancy Weight Change||baseline to 34 weeks gestation|Participants returning for follow up visit or validated clinical data|||kg||Standard Deviation|Mean
2740270|NCT00950235|Primary|Maternal Weight Change|We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.|baseline to 2 weeks post partum|Data was from follow up visit or validated clinical data|||kg||Standard Deviation|Mean
2740271|NCT00950183|Secondary|Postoperative Complications||postop day 1 up to postop day 14|Data not analyzed due to study termination||||||
2740272|NCT00950183|Secondary|Surgical Complications||Day of Surgery|Data not analyzed due to study termination||||||
2740273|NCT00950183|Secondary|Patient Satisfaction||first postoperative visit (between postop day 10 and 14)|Data not analyzed due to study termination||||||
2740274|NCT00950183|Secondary|Narcotic Pain Medication Usage||postop day 1 up to postop day 14|Data not analyzed due to study termination.||||||
2740275|NCT00950183|Primary|Visual Analog Scale (VAS) Pain Scores||postop day 1 up to postop day 14|Data not analyzed due to study termination||||||
2740276|NCT00950170|Secondary|Total Number of Events of Potential Less-Than-Expected Therapeutic Effect (LETE) in the Low Recovery Setting|LETE was lower than expected recovery of FVIII in the opinion of the investigator following infusion of study drug in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known compromised study drug, faulty administration of study drug including inadequate dosing).|2 years|Efficacy analysis set consisted of all participants who had received at least 1 dose of ReFacto AF.|||Events|||Number
2740277|NCT00950170|Secondary|Percentage of Bleeding Episodes With Less-Than-Expected Therapeutic Effect (LETE) in the Prophylaxis Setting|LETE in prophylaxis setting if there was a spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of study drug (which was not used to treat a bleed) in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose [a dose less than that prescribed in participant's regimen], known lack of adherence to the prescribed prophylaxis regimen, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for the bleed in the opinion of the investigator, traumatic injury responsible for bleeding.|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Percentage of bleeding episodes|Routine prophylaxis infusions|95% Confidence Interval|Number
2740278|NCT00950170|Secondary|Percentage of Bleeding Episodes With Less-Than-Expected Therapeutic Effect (LETE) in On-Demand (OD) Setting|"LETE occurs in OD setting if participant recorded 2 successive No Response (no improvement at all between infusions, or condition worsens) ratings after 2 successive infusions of study drug. Infusions must have been given within 24 hours (hr) of each other for treatment of same bleeding event in absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of greater than (>) 4 hr between onset of bleed to infusion, delay of >24 hr before administration of a follow-up infusion, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator, ongoing trauma responsible for continued bleeding."|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Percentage of bleeding episodes|Bleeding episodes|95% Confidence Interval|Number
2740279|NCT00950170|Secondary|Number of Participants Who Required Dose Escalation of Their Prescribed Prophylaxis Regimen During Their Participation in This Study|The number of participants who met the dose escalation criteria were prescribed a higher dose and/or were prescribed more frequent doses. When dose escalation was required, the specific dose and dosing schedule was at the investigator's discretion.|2 years|Efficacy analysis set consisted of all participants who had received at least 1 dose of ReFacto AF.|||Participants|||Count of Participants
2740282|NCT00950170|Secondary|Mean Dose (IU) of Study Drug Consumed Per Infusion by Weight|Mean dose for each participant was calculated as participant's total factor consumption (in IU) divided by the number of infusions administered and then dividing by participant's weight (the most recently recorded).|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||International units per kilogram||Standard Deviation|Mean
2740283|NCT00950170|Secondary|Consumption of Total International Units of Factor VIII Per Year by Weight|Consumption of total international units of Factor VIII per year by weight was calculated for a participant: the total consumption of factor VIII divided by participant's treatment interval duration (in days), then multiplying by 365.25 and then dividing by participant's weight (the most recently recorded).|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||International units per kilogram*years||Standard Deviation|Mean
2740284|NCT00950170|Secondary|Consumption of Total International Units of Factor VIII by Weight|Consumption of total international units of Factor VIII by weight was calculated for a participant: dividing the total consumption of factor VIII by participant's weight (the most recently recorded).|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||International units per kilogram||Standard Deviation|Mean
2740285|NCT00950170|Secondary|Mean Dose (IU) of Study Drug Consumed Per Infusion|Mean dose for each participant was calculated as participant's total factor VIII consumption (in IU) divided by the number of infusions administered.|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||International units per infusion||Standard Deviation|Mean
2740286|NCT00950170|Secondary|Consumption of Total International Units of Factor VIII Per Year|Consumption of total international units of Factor VIII per year was calculated for a participant: dividing the total consumption of factor VIII by participant's treatment interval duration (in days), then multiplying by 365.25.|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||International units per year||Standard Deviation|Mean
2740287|NCT00950170|Secondary|Consumption of Total International Units of Factor VIII||2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||International units||Standard Deviation|Mean
2740288|NCT00950170|Secondary|Total Number of Breakthrough Bleeding Episodes Occurring Within 48 Hours After a Prophylaxis Infusion of ReFacto AF|The number of breakthrough bleeds (spontaneous or traumatic) within 48 hours following a prophylaxis dose of ReFacto AF are summarized. If there was more than 1 bleed location (like ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Bleeding episodes|||Number
2740289|NCT00950170|Secondary|Total Number of Infusions Needed for Resolution of Bleeding Episodes Classified on Basis of Response to Study Drug Infusion|Number of infusions of Refacto AF required for resolution of a bleeding episodes were classified on basis of the response at 4-point response scale of assessment (excellent, good, moderate and no response). Excellent: definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good: definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate: probable or slight improvement starting after 8 hr following infusion, at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as: Data Not Recorded.|Within 48 hours after infusion, up to 2 years treatment duration|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Infusions|Infusions||Number
2740290|NCT00950170|Secondary|Total Number of Infusions to Treat a New Bleed Classified on Basis of Response to First On-Demand Treatment With Refacto AF|Number of infusions of Refacto AF required to treat a new bleed were classified on basis of the response to at 4-point response scale of assessment (excellent, good, moderate and no response). Assessment was completed each time a participant experienced a new bleed requiring an 'on-demand' IV infusion. Excellent: definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good: definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate: probable or slight improvement starting after 8 hr following infusion, at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as: Data Not Recorded.|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||Infusions|Infusions||Number
2740291|NCT00950170|Secondary|Annualized Bleeding Rate (ABR)|Annualized bleeding rate was calculated as the number of bleeds divided by the treatment interval duration (enrollment visit to final visit) and then multiplied by 365.25. If there was more than 1 bleed location (like ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.|2 years|Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.|||bleeds per year||Standard Deviation|Mean
2740292|NCT00950170|Primary|Percentage of Participants Who Developed Clinically Significant Factor VIII (FVIII) Inhibitors During the Course of the Study|Percentage of participants who developed clinically significant FVIII inhibitors: those persistent over a defined period with clinically impactful effects like breakthrough bleed, low recovery, etc., during the course of the study.|2 years|Analysis set included all participants who had received at least 1 dose of ReFacto AF and those were observed for clinically significant FVIII inhibitors.|||Percentage of participants||95% Confidence Interval|Number
2740293|NCT00949988|Secondary|A Multi-Center Phase I/II Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia|"Phase II:~To determine the efficacy of D+R treatment in patients with relapsed/refractory CLL as measured by complete and partial response rates"|2 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2740294|NCT00949988|Secondary|To Evaluate Pharmacokinetics for Dasatinib in the Treated Patients||2 years|This study only enrolled three participants and all three participants withdrew. No data analysis was performed.||||||
2740301|NCT00949975|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Participants|||Number
2740302|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
2740303|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Deviation|Mean
2740304|NCT00949975|Secondary|Six-minute Walk Test - End-value Distance Walked (m)|distance walked on vist 6 - last on treatment clinic visit|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||m||Standard Error|Least Squares Mean
2740305|NCT00949975|Secondary|Six-minute Walk Test - Distance Walked at Baseline (m)||Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||m||Standard Deviation|Mean
2740306|NCT00949975|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Inhalations||Standard Error|Least Squares Mean
2740307|NCT00949975|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12|Measured at clinic visits:1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Error|Least Squares Mean
2740308|NCT00949975|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2740309|NCT00949975|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Error|Least Squares Mean
2740310|NCT00949975|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2740311|NCT00949975|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Error|Least Squares Mean
2740324|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740312|NCT00949975|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2740313|NCT00949975|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740314|NCT00949975|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740315|NCT00949975|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2740316|NCT00949975|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Deviation|Mean
2740317|NCT00949975|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740318|NCT00949975|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740319|NCT00949975|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740320|NCT00949975|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740321|NCT00949975|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740322|NCT00949975|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740323|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740531|NCT00947544|Secondary|Plasma PAA (Phenylacetate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||μg•h/mL AUC 0-24||Standard Deviation|Mean
2740325|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740326|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740327|NCT00949975|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2740328|NCT00949975|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
2740329|NCT00949910|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.|||months||95% Confidence Interval|Median
2740330|NCT00949910|Secondary|Percentage of Participants Who Died|The percentage of participants (in nearest integer) who died from any cause was reported.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
2740331|NCT00949910|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.|||months||95% Confidence Interval|Median
2740332|NCT00949910|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.|||percentage of participants|||Number
2740333|NCT00949910|Secondary|Percentage of Participants by Best Overall Response According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
2740334|NCT00949910|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
2740344|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 4|"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg"|Week 4|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.|||percentage of participants analyzed|||Number
2766113|NCT00765388|Primary|Preference of Sensura vs Moderma|Subjects were asked which of the tested products they preferred; SenSura or Moderma.|4 weeks||||percentage of prefering the product|||Number
2740335|NCT00949910|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
2740336|NCT00949884|Other Pre-specified|Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure|The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Baseline, Week 2|The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2740337|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
2740338|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
2740339|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
2740340|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
2740341|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 8|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.|||mmHg||Standard Error|Least Squares Mean
2740342|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 4|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.|||mmHg||Standard Error|Least Squares Mean
2740343|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 8|"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg"|Week 8|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.|||percentage of participants analyzed|||Number
2740532|NCT00947544|Secondary|Urinary PAGN 24-hour Excretion Values on NaPBA vs. HPN-100 (Switch Over)|Urinary PAGN (phenylacetylglutamine) 24-hour excretion. Urine was collect during 0-12 hrs and 12-24 hrs.|Day 7 (NaPBA) and Day 14 (HPN-100)||||μg||Standard Deviation|Mean
2740345|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2740346|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2740347|NCT00949884|Post-Hoc|Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8|Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.|Week 8|Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.|||percentage of population|||Number
2740348|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2740349|NCT00949884|Secondary|Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2740350|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2740351|NCT00949884|Primary|Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2740352|NCT00949715|Secondary|Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.|Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.|Whole time from baseline to 24 months averaged by day|All subjects who meet inclusion/exclusion criteria for the study.|||minutes per day||Standard Deviation|Mean
2740353|NCT00949715|Secondary|Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.|Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.|24 months|All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points|||mL||95% Confidence Interval|Mean
2740354|NCT00949715|Secondary|Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.|Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.|24 months|Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement|||percentage of LVEF||95% Confidence Interval|Mean
2740355|NCT00949715|Primary|Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month|Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view|24 months|Subjects who had LVEF measurements from both baseline and 24 month timepoints|||percentage of LVEF||95% Confidence Interval|Mean
2740356|NCT00949702|Secondary|Percentage of Patients With Adverse Event|The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants|||Number
2740357|NCT00949702|Secondary|Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)|Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.|Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1|Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.|||ms||95% Confidence Interval|Mean
2740358|NCT00949702|Secondary|Vemurafenib Plasma Levels at Various Treatment Cycles|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.|Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.|||μg/mL||Standard Deviation|Mean
2740359|NCT00949702|Secondary|Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.|||μg⋅h/mL||Standard Deviation|Mean
2740360|NCT00949702|Secondary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.|||μg/mL||Standard Deviation|Mean
2740361|NCT00949702|Secondary|Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline|Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants||95% Confidence Interval|Number
2740362|NCT00949702|Secondary|Overall Survival|Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||95% Confidence Interval|Median
2740363|NCT00949702|Secondary|Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||95% Confidence Interval|Median
2740364|NCT00949702|Secondary|Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||Inter-Quartile Range|Median
2744174|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
2740365|NCT00949702|Secondary|Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||95% Confidence Interval|Median
2740366|NCT00949702|Secondary|Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants||95% Confidence Interval|Number
2740367|NCT00949702|Primary|Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants||95% Confidence Interval|Number
2740368|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 43|Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.|Day 43.|Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.|||ng/mL.||Geometric Coefficient of Variation|Geometric Mean
2740369|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 29|Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.|Day 29.|Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.|||ng/mL.||Geometric Coefficient of Variation|Geometric Mean
2740370|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 22|Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.|Day 22.|Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.|||ng/mL.||Geometric Coefficient of Variation|Geometric Mean
2740371|NCT00949650|Secondary|HRQOL: Time to Deterioration in Pain|HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks).|RS.|||Months.||95% Confidence Interval|Median
2740372|NCT00949650|Secondary|HRQOL: Time to Deterioration in Dyspnoea|HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks).|RS.|||Months.||95% Confidence Interval|Median
2740373|NCT00949650|Secondary|Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing|HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks).|RS.|||Months.||95% Confidence Interval|Median
2740374|NCT00949650|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|"ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.~Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.~Ambulatory (>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.~Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.~Completely disabled, cannot carry on any self-care, totally confined to bed or chair.~Dead."|Throughout the trial until progression (every 3 weeks), up to 28 months.|RS. Only patients with baseline and at least one post-baseline assessment were included.|||Participants|||Number
2740375|NCT00949650|Secondary|Change From Baseline in Body Weight|Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.|Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.|RS. Only patients with baseline and at least one post-baseline assessment were included.|||Kg.||Standard Deviation|Mean
2740376|NCT00949650|Secondary|Tumour Shrinkage|Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.|||mm.||Standard Error|Mean
2740377|NCT00949650|Secondary|Overall Survival (OS) Time|OS was defined as time from randomisation to death.|From randomisation to cut-off date (17MAR2017).|RS.|||Months.||95% Confidence Interval|Median
2740378|NCT00949650|Secondary|Percentage of Participants With Disease Control (DC)|DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|RS.|||Percentage of participants with DC.||95% Confidence Interval|Number
2740379|NCT00949650|Secondary|Percentage of Patients With Objective Response (OR)|OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|RS.|||Percentage of patients with OR.||95% Confidence Interval|Number
2740380|NCT00949650|Primary|Progression-Free Survival (PFS) Time|PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|Randomised set (RS)|||Months.||95% Confidence Interval|Median
2740381|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected|Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."|||participants|||Number
2740382|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms|"Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. Other in the category included abdominal pain, breathlessness, thoracic pain and tired."|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."|||participants|||Number
2740383|NCT00949533|Secondary|Percentage of Participants With A Reduction in Viral Load|Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.|Baseline, Day 5|ITT population.|||percentage of participants|||Number
2740384|NCT00949533|Primary|Percentage of Participants Excreting Resistant Virus|Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."|||percentage of participants|||Number
2740385|NCT00949325|Secondary|Clinical Benefit Rate|Number of days from documented improvement to disease progression.|up to 5 years|Although the original protocol specified that “clinical benefit rate” would be an outcome measure that would be obtained, appropriate data were not collected, so this outcome measure cannot be evaluated or reported.||||||
2740386|NCT00949325|Secondary|Duration of Response|Number of days until documentation of disease progression or date of death from other cause|up to 5 years|Although the original protocol specified that “duration of response” would be an outcome measure that would be obtained, appropriate data were not collected, so this outcome measure cannot be evaluated or reported.||||||
2740387|NCT00949325|Secondary|Time to Response|Number of days after 2 cycles of treatment, until maximal response is observed.|up to 5 years|Although the original protocol specified that “time to maximal response” would be an outcome measure that would be obtained, appropriate data were not collected, so this outcome measure cannot be evaluated or reported.||||||
2740388|NCT00949325|Secondary|Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2||up to 5 years|Subjects who received Temsirolimus MTD, 20 mg/m^2 in Phase I of the study and all subjects in the Phase II study were included from both Phase I and Phase II of the study are included.|||Days||Full Range|Mean
2740389|NCT00949325|Secondary|Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|Interval from start of treatment to disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression|up to 3 years||||Days||Full Range|Mean
2740390|NCT00949325|Secondary|Drug Clearance|Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS.|Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.||||L/hr/m2||Standard Deviation|Mean
2740391|NCT00949325|Secondary|Area Under the Curve (AUC)|AUC was calculated using a single compartment model.|Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.|Seven subjects had complete series of blood samples available for evaluation for both Temsirolimus, the parent drug and Sirolimus, the active metabolite. The analysis was per protocol. The number (N) evaluable samples is less than the number of collected samples due to inadvertent processing mishaps.|||ng*hr/ml||Standard Deviation|Mean
2740459|NCT00948688|Primary|Progression Free Survival (PFS) at 7 Months From Registration|Progression free survival was defined as the duration of time from registration on study to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.|7 months||||months||95% Confidence Interval|Median
2740392|NCT00949325|Secondary|Maximum Observed Plasma Concentration (Cmax)|Whole blood temsirolimus and sirolimus levels were measured by LC/MS/MS|Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.|Seven subjects had complete series of blood samples available for evaluation for both Temsirolimus, the parent drug and Sirolimus, the active metabolite. The number (N) evaluable participants is less than the number of participants from whom samples were collected due to inadvertent processing mishaps.|||mg/mL||Standard Deviation|Mean
2740393|NCT00949325|Secondary|Objective Response Rate|Number of participants who completed at least 2 treatment cycles with evidence of response. Response is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|up to 5 years|Only participants who completed at least 2 treatment cycles (14/18 participants) were included to assess this outcome measure.|||Participants|||Count of Participants
2740394|NCT00949325|Secondary|Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|Interval from Date of start of treatment to date of disease progression or death from any cause. Disease progression is defined as at least 20% increase in sum of longest diameter of target lesions or appearance of any new lesions. Subjective determination of significant worsening of disease-related symptoms was considered clinical disease progression.|up to 3 years|The number of analyzed participants does not include the 2 participants treated at the MTD who stopped treatment for early disease-related adverse events.|||days||Full Range|Median
2740395|NCT00949325|Primary|Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2|Number of days from day 1 of treatment until date of death from any cause.|up to 5 years|The number of analyzed participants does not include the 2 participants treated at the MTD who stopped treatment for early disease-related adverse events.|||days||Full Range|Median
2740396|NCT00949325|Primary|Part 1: Incidence of Dose Limiting Toxicities|Dose limiting toxicities in each dose cohort.|End of second 28-day cycle||||participants|||Number
2740397|NCT00949234|Primary|Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit||24 Weeks|254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures|||HIV Exposure Events|HIV Exposure Events||Count of Units
2740398|NCT00949117|Secondary|Change in Weight for Age Z-score From Baseline Through 24 Weeks|Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.|Baseline and 24 weeks||||z score||Standard Deviation|Mean
2740399|NCT00949117|Secondary|Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24||24 weeks|Outcome not assessed as the one subject that completed the protocol was too young to complete the PedsFAACT quality of life assessment.||||||
2740400|NCT00949117|Secondary|Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition||24 weeks|Outcome not assessed as the one subject that completed the protocol did not have the prealbumin lab drawn at the 24 week visit and body composition tests assessed.||||||
2740401|NCT00949117|Secondary|Body Mass Index as Assessed at Baseline and 24 Weeks|Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.|24 weeks||||kg/m^2||Standard Deviation|Mean
2740402|NCT00949117|Primary|Difference Between Measures of Weight at Baseline and at Week 24|Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.|24 weeks||||kilograms||Standard Deviation|Mean
2740403|NCT00949078|Primary|Omalizumab Received Before OFC 2|total mg|up to 6 months||||mg||Full Range|Median
2740404|NCT00949078|Primary|Omalizumab Received Before OFC 2|Number of doses|up to 6 months||||number of doses||Full Range|Median
2740405|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3|mg|up to 8 weeks||||mg||Full Range|Median
2740406|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2|mg|up to 8 weeks||||mg||Full Range|Median
2740407|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1|mg|up to 8 weeks||||mg||Full Range|Median
2740408|NCT00949078|Primary|Total Immunoglobulin E (IgE) After Pn-BHR Response|kU/L (range)|up to 6 months||||kU/L||Full Range|Median
2740409|NCT00949078|Primary|Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response|kU/L (range)|up to 6 months||||kU/L||Full Range|Median
2740410|NCT00949078|Primary|Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response|percentage|change from baseline to up to 6 months||||percentage change Peanut specific IgE||Full Range|Median
2740411|NCT00949078|Primary|Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8|Presence or absence of this change|up to 6 months||||Participants|||Count of Participants
2740430|NCT00948818|Secondary|12-Week Percent of Abdominal Pain-free (APF) Days|"Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst~Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Percent||Standard Deviation|Mean
2740460|NCT00948688|Primary|Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy.|The maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.|6 weeks||||milligrams per day|||Number
2740412|NCT00948974|Secondary|Behavioral Assessment Test|The assessment consists of two role-played interpersonal interactions and an impromptu speech. The role-plays were video recorded for subsequent rating by two independent assessors. Using a 5-point Likert scale (1 = poor and 5 = excellent), assessors rated global social skills, which were comprised of assessments of verbal content (e.g., amount of speech during task and degree to which speech was relevant and appropriate), nonverbal skills (e.g., degree of fidgeting and eye contact; appropriateness of gestures and posture), and paralinguistic skills (e.g., appropriateness of tone, enunciation, inflection, and rate). Prior research has employed this behavioral assessment protocol (Glassman et al., 2016; Herbert et al., 2005). These results reflect global social skills, which reflect the sum of ratings of verbal, nonverbal, and paralinguistic skills. Scores range from 3 to 15 with higher scores reflecting better social skills.|baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)|A subset of randomized participants (n = 12 for ACT and n = 11 for tCBT) completed this behavioral assessment task.|||units on a scale||Standard Deviation|Mean
2740413|NCT00948974|Secondary|Outcomes Questionnaire|The Outcomes Questionnaire is a 45-item measure that assesses functioning and is comprised of three subscales: symptom distress, interpersonal relationships, and social role performance, that are combined to create a total score. Scores range from 45 to 180, where higher scores reflect greater levels of dysfunction.|baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)||||units on a scale||Standard Deviation|Mean
2740414|NCT00948974|Primary|Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale|The SPAI social phobia assess symptoms of social anxiety in the presence of (a) strangers, (b) authority figures, (c) members of the opposite sex, and (d) people in general. The subscale ranges from 32 to 192, where higher scores reflect more severe symptoms of social anxiety.|baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)||||units on a scale||Standard Deviation|Mean
2740415|NCT00948935|Secondary|Response Rate From Combination Chemotherapy||5 months||||Participants|||Count of Participants
2740416|NCT00948935|Primary|Progression Free Survival Rate at Five Months||5 months||||percentage of participants|||Number
2740417|NCT00948922|Other Pre-specified|Percentage of Participants With Acute or Chronic Graft-versus-host Disease (GVHD) Following Transplant|Percentage of participants with Acute or Chronic GVHD following transplant|End of 2 year, post transplant follow-up|Allogenic Stem Cell Transplant patients only. Autologous patients do not suffer from GVHD.|||percentage of participants|||Number
2740418|NCT00948922|Secondary|Molecular Complete Response (CR) Rates in Patients With Multiple Myeloma|Complete Response according to International Myeloma Working Group uniform response criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.|End of 2 year, post transplant follow-up|Patients were in very good partial response at the time on enrollment without sufficient plasma cells in bone marrow to be able to perform assay for molecular response.||||||
2740419|NCT00948922|Secondary|Overall Survival (OS) Rate|Overall survival in participants with multiple myeloma treated with Bortezomib (Velcade®) containing conditioning regimen and autologous as well as allogeneic transplantation.|End of 2 year, post transplant follow-up||||percentage||95% Confidence Interval|Number
2740420|NCT00948922|Primary|Progression Free Survival (PFS)|PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|End of 2 year, post transplant follow-up|All participants evaluable at time of analysis|||Participants|||Count of Participants
2740421|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants|The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.|Randomization to 24 months of age||||Episodes per person year at risk|||Number
2740422|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants|The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6-24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.|6 to 24 months of age||||Episode per person year at risk|||Number
2740423|NCT00948896|Secondary|Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk||24 months to 36 months of age||||Incidence per person year at risk|||Number
2740424|NCT00948896|Secondary|Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs|NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004|Time from randomization until 24 months of age||||incidence per person-year at risk|||Number
2740425|NCT00948857|Primary|Live Birth|Live Birth outcome compared between DHEA active treatment and Placebo|9 months|This study was closed for futility because of difficulty finding patients willing to undergo randomization.|||participants|||Number
2740426|NCT00948857|Secondary|Clinical Pregnancy||12 months|||||||
2740427|NCT00948857|Secondary|Androgen Side Effects||12 months|||||||
2740428|NCT00948857|Secondary|Endocrine Effects||12 months|||||||
2740429|NCT00948857|Primary|Live Birth||24 months|||||||
2740487|NCT00948155|Secondary|Nicotine Levels From Urine Samples|Nicotine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||micromolar||Standard Deviation|Mean
2740431|NCT00948818|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.~The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
2740432|NCT00948818|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
2740433|NCT00948818|Secondary|12-Week Change in Bloating|"Bloating was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2740434|NCT00948818|Secondary|12-Week Change in Abdominal Discomfort|"Abdominal Discomfort is measured on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2740435|NCT00948818|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2740436|NCT00948818|Secondary|12-Week Severity of Straining|"Straining is measured on a 5-point scale where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2740437|NCT00948818|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2740438|NCT00948818|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency Rate|The number of Spontaneous Bowl Movements experienced per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per week||Standard Error|Least Squares Mean
2740439|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.|"A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.~The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
2740440|NCT00948818|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.~The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
2740488|NCT00948155|Secondary|Total Nicotine Metabolites From Urine Samples|Total urinary metabolites from urine samples collected at Day 1 and Day 21|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||micromolar||Standard Deviation|Mean
2740441|NCT00948818|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participant|||Number
2740442|NCT00948818|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
2740443|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
2740444|NCT00948792|Primary|30 Minute-6 Hour Difference in Platelet Counts||30 minutes - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.|||Platelets (*10^3/mm^3)|Participants|Full Range|Median
2740445|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.|Baseline - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.|||Platelets (*10^3/mm^3)|Participants|Full Range|Median
2740446|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.|Baseline-30 minutes after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.|||Platelets (*10^3/mm^3)|Participants|Full Range|Median
2740447|NCT00948766|Secondary|Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.|||Percentage of patients|||Number
2740448|NCT00948766|Secondary|Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2740457|NCT00948688|Secondary|Number of Participants Experiencing Unacceptable Toxicity|All participants who receive at least one dose of study treatment were evaluable for toxicity. Unacceptable toxicity is based on the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Most grade 3 (severe) or 4 (life-threatening) events are considered to be unacceptable toxicities -- exceptions include nausea or vomiting, fatigue, and alopecia. Hematologic toxicities need to be either grade 4 or last for protocol-defined durations to be considered unacceptable.|1 year||||Participants|||Count of Participants
2740458|NCT00948688|Secondary|Progression Free Survival|Progression free survival for this endpoint was defined as the duration of time from beginning of the patients' initial chemotherapy to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.|2 years||||months||95% Confidence Interval|Median
2740449|NCT00948766|Secondary|Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2740450|NCT00948766|Secondary|Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24|The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2740451|NCT00948766|Secondary|Core Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Percentage of patients|||Number
2740452|NCT00948766|Primary|Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2740453|NCT00948766|Primary|Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2740454|NCT00948688|Secondary|Resectability Rate|Percentage of patients able to undergo surgical resection after protocol therapy.|5 months|One participant excluded from this analysis due to non-compliance with study drug administration.|||Participants|||Count of Participants
2740455|NCT00948688|Secondary|Response Rate|Participants who have either a complete response (disappearance of all target lesions), partial response (at least 30% decrease in sum of longest diameter of target lesions) or stable disease (decrease in size of less than 30% or increase in size of less than 20%).|1 year|One participant excluded from this analysis due to non-compliance with study drug administration.|||Participants|||Count of Participants
2740456|NCT00948688|Secondary|Overall Survival|Percentage of participants still alive at 1 year after enrollment on study|1 year|One participant excluded from this analysis due to non-compliance with study drug administration.|||Participants|||Count of Participants
2740489|NCT00948155|Primary|Daily Cigarette Consumption|Average of the number of cigarettes smoked per day|Two 21 day study periods||||number of cigarettes smoked per day||Standard Error|Mean
2766549|NCT00763009|Secondary|To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.||6-12 months|The study was terminated due to poor enrollment||||||
2740461|NCT00948675|Secondary|Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)|Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2740462|NCT00948675|Secondary|Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)|Overall Response rate (ORR) is the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2740463|NCT00948675|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.|Randomization to date of death from any cause up to 39.49 months|All randomized participants. The number of participants censored was 52 for pemetrexed + carboplatin group and 56 for paclitaxel + carboplatin + bevacizumab group.|||months||90% Confidence Interval|Median
2740464|NCT00948675|Secondary|Progression Free Survival (PFS)|PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease up to 39.49 months|All randomized participants. The number of participants censored was 35 for pemetrexed + carboplatin group and 49 for paclitaxel + carboplatin + bevacizumab group.|||months||90% Confidence Interval|Median
2740465|NCT00948675|Primary|Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease or treatment discontinuation up to 39.49 months|All randomized participants. The number of participants censored was 30 for pemetrexed + carboplatin group and 35 for paclitaxel + carboplatin + bevacizumab group.|||months||90% Confidence Interval|Median
2740466|NCT00948610|Secondary|Cellular Inflammation|Percentage of monocytes producing interleukin-6 at post-infusion day 2 in placebo vs. remicade|Post-infusion day 2||||percentage of monocytes||Standard Deviation|Mean
2740467|NCT00948610|Primary|Slow Wave Sleep|Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade|Post-infusion day 2||||Minutes||Standard Deviation|Mean
2740468|NCT00948506|Secondary|Subject-reported Adverse Events or Abnormal Findings|Number of participants who reported an adverse event (as assessed by subject interview and if indicated, physical exam) or had abnormal finding on urine and blood laboratory examination|up to 16 weeks|The analysis was performed using intention-to-treat, whereby all enrolled participants who received treatment were analyzed.|||participants|||Number
2740469|NCT00948506|Primary|Physician's Global Assessment (PGA) of Hair Density|Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).|up to 8 weeks or end of active treatment|The analysis was performed using intention-to-treat and all enrolled participants who received treatment were included in the analysis. For participants who withdrew during treatment, the data from their last visit were carried forward.|||participants|||Number
2740470|NCT00948441|Secondary|Safety, Side Effects|collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study.|7 months per study patient|collected adverse events during each time period|||participants|||Number
2740471|NCT00948441|Primary|Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.|For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.|7 months per study patient|This was a crossover study. Each participant served as their own control. Infections in each time period of the study were compared. Infections with using ethanol locks and infections while using heparin locks.|||number of CRBSI per 1000 catheter days|||Number
2740472|NCT00948389|Other Pre-specified|Number of Participants With Disease Progression at 12 Months|As measured by brain magnetic resonance imaging.|12 months|Treated participants|||participants|||Number
2740473|NCT00948389|Primary|Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria|Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants|||participants|||Number
2740474|NCT00948389|Primary|Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria|Neutrophils (neutropenia): Grade (gr)1 <LLN-1500/mm3; Gr2 <1500-1000/mm3; Gr3 <1000-500/mm3; Gr4 <500/mm3. Leukocytes (leukopenia): Gr1 <LLN-3000/mm3; Gr2 <3000-2000/mm3; Gr3 <2000-1000/mm3; Gr4 <1000/mm3. Lymphocytes (lymphocytopenia): Gr1 <LLN-800/mm3; Gr2 <800-500/mm3; Gr3 <500-200/mm3; Gr4 <200/mm3. Platelets (thrombocytopenia): Gr1 <LLN-75,000/mm3; Gr2 <75,000-50,000/mm3; Gr3 <50,000-25,000/mm3; Gr4 <25,000/mm3. Hemoglobin (anemia): Gr1 <LLN-10.0 g/dL; Gr2 <10.0-8.0 g/dL; Gr3 <8.0-6.5 g/dL; Gr4 <6.5 g/dL. LLN/ULN=lower/upper limit of normal (normal ranges may vary by local laboratories).|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants|||participants|||Number
2740475|NCT00948389|Primary|Deaths Within 30 Days of Protocol Treatment Discontinuation||From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0).|Treated participants|||participants|||Number
2740476|NCT00948389|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents.|The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1.|Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.|||participants|||Number
2740477|NCT00948389|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs|SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|All treated participants|||participants|||Number
2740478|NCT00948298|Secondary|Changes in Sitting and 24 Ambulatory Blood Pressure|Improved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure.|12 weeks||||mmHg||Standard Deviation|Mean
2740479|NCT00948298|Primary|Pulse Wave Velocity for Vascular Stiffness|The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.|12 Weeks||||m/s||Standard Deviation|Mean
2740480|NCT00948246|Secondary|Change in Weight|Change in weight (in kilograms) at baseline to 12 months|12 months||||pounds||95% Confidence Interval|Mean
2740481|NCT00948246|Secondary|Change in BMI|Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months|12 months||||kg/m2||95% Confidence Interval|Mean
2740482|NCT00948246|Secondary|% Excess Weight Loss|Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.|12 months||||percentage of excess weight loss||95% Confidence Interval|Mean
2740483|NCT00948246|Primary|Feasibility and Ease of Implantation|"Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is very easy and 5 is impossible."|< 1day|Intent-to-treat|||percentage of subjects|||Number
2740484|NCT00948155|Secondary|Subjective Measures to Assess Smoking Urges|Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach's α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period.|Days 21 of each of the two 21-day study periods, range 1(low)-7(high)|Subjects who completed both 21 day placebo and drug periods.|||units on a scale||Standard Deviation|Mean
2740485|NCT00948155|Secondary|Carbon Monoxide Levels|Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||parts per million||Standard Error|Mean
2740486|NCT00948155|Secondary|Cotinine Levels From Urine Samples|Cotinine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||micromolar||Standard Deviation|Mean
2740490|NCT00948155|Primary|The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.|Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.|Days 1, 7, 21 of each of two 21 day study periods|All participants who completed the task were included in the analysis|||number of puffs chosen of a maximum 24||Standard Error|Mean
2740491|NCT00948155|Primary|Smoking Topography: Total Puff Volume|Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.|Days 1-21 of each of 2 study periods|All those participants who completed both study periods were included in the analysis.|||milliliters||Standard Error|Mean
2740492|NCT00948090|Secondary|Overall Response Rate|The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points.|Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Participants|||Number
2740493|NCT00948090|Secondary|Number of Transplant-related Death Events Until Day 100.|Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.|Day 100|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Transplant-related death|||Number
2740494|NCT00948090|Secondary|Number of Death Events in 2 Years.|The time of overall survival was defined as the time from transplantation to death of all causes.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Deaths|||Number
2740495|NCT00948090|Primary|Number of Progression Events in 2 Years.|The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Event|||Number
2740496|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase II, Baseline to 60 days following first treatment.|Of the 79 participants enrolled, 78 were evaluable and 1 participant withdrew from study.|||participants|||Number
2740497|NCT00948064|Primary|Response Rate|Number of participants with Complete Response (CR) in AML requiring disappearance of all signs and symptoms related to disease, normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a marrow with 5% or less marrow blasts; a hematologic improvement (HI) defined as a CR except for a platelet count increase by 50% to above 30 x 10^9/L. For MDS, the International Working Group criteria used to assess response.|12-18 Months|Out of 79 participants enrolled in Phase II, 2 participants were not evaluable - 1 participant was removed from study per treating physician discretion and the other was removed per participant's request.|||participants|||Number
2740498|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase I, Baseline to 60 days following first treatment.|Of the 31 enrolled participants, 30 were evaluable and 1 participant never received treatment.|||participants|||Number
2740499|NCT00947882|Secondary|Mean Change in Maximum Urinary Flow (Qmax)|Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
2740500|NCT00947882|Secondary|Mean Percentage Change in Total Prostate Volume (TPV)|TPV was measured directly by standardised trans-rectal ultrasound (TRUS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
2740501|NCT00947882|Secondary|Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS|A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.|At Month 3, Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage of participants|||Number
2740502|NCT00947882|Secondary|Mean Change in IPSS|This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.|From Baseline to Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
2740873|NCT00945243|Primary|Assessment of Neck Disability Index Scores|Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.|24 months|8 subjects had data at 24 months|||percentage of subjects|||Number
2740503|NCT00947882|Primary|Mean Change in International Prostate Symptom Score (IPSS)|"This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.~The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score."|From Baseline to Month 3 after Dosing|"FAS. The as planned patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
2740504|NCT00947856|Secondary|Incidence of Antitherapeutic Antibodies|Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment|Up to 39 months|Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples.|||participants or experiences|Retreatment or Extension Txt Experiences||Number
2740505|NCT00947856|Secondary|Overall Survival|Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause|Up to approximately 41 months|Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once.|||months|Retreatment or Extension Trt Experiences|95% Confidence Interval|Median
2740506|NCT00947856|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause|Up to approximately 29 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.|||months|Retreatment Experiences|95% Confidence Interval|Median
2740507|NCT00947856|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death|Up to 38 months|Participants with objective response among those who received retreatment|||months|Retreatment Experiences|95% Confidence Interval|Median
2740508|NCT00947856|Primary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|Up to 39 months|All participants who received treatment|||participants|||Number
2740509|NCT00947856|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 39 months|All participants who received treatment|||participants|||Number
2740510|NCT00947856|Primary|Objective Response Rate by Investigator|Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 38 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.|||percentage of retreatment experiences|Retreatment Experiences|95% Confidence Interval|Number
2740511|NCT00947791|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
2740512|NCT00947791|Secondary|Clinician-Administered Dissociative States Scale (CADSS)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
2740513|NCT00947791|Secondary|Brief Psychiatric Rating Scale (BPRS)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
2740514|NCT00947791|Secondary|Young Mania Rating Scale (YMRS)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
2740515|NCT00947791|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
2740516|NCT00947791|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
2740517|NCT00947765|Primary|Pain(at 6 Months): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|6 months||||Units on a scale||Standard Deviation|Mean
2740530|NCT00947544|Secondary|Plasma PBA (Phenylbutyrate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||µg*h/ml AUC 0-24||Standard Deviation|Mean
2740518|NCT00947765|Primary|Pain(at 6 Months): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|6 months||||Units on a scale||Standard Deviation|Mean
2740519|NCT00947765|Primary|Pain(at 12 Weeks): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|12 weeks||||Units on a scale||Standard Deviation|Mean
2740520|NCT00947765|Primary|Pain(at 12 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|12 weeks||||Units on a scale||Standard Deviation|Mean
2740521|NCT00947765|Primary|Pain(at 4 Weeks): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|4 weeks||||Units on a scale||Standard Deviation|Mean
2740522|NCT00947765|Primary|Pain(at 4 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|4 weeks||||Units on a scale||Standard Deviation|Mean
2740523|NCT00947765|Primary|Pain(at 1 Week): Nirschl Staging (0 to 7)|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.|||Units on a scale||Standard Deviation|Mean
2740524|NCT00947765|Primary|Pain (at 1 Week): Visual Analogue Scale(0 to 10)|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever."|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.|||Units on a scale||Standard Deviation|Mean
2740525|NCT00947752|Secondary|Degree of Pain Within 5 Mins After Injection|"A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent no pain and up to 100 mm to represent worst possible pain; subjects drew a continuous line to represent their level of pain."|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.|||Scores on a scale||Standard Deviation|Mean
2740526|NCT00947752|Primary|Subject-reported Pain Associated Immediately After Each Injection|"A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent no pain and up to 100 mm to represent worst possible pain; subjects drew a continuous line to represent their level of pain."|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.|||Scores on a scale||Standard Deviation|Mean
2740527|NCT00947661|Primary|Change in Intraocular Pressure From Baseline to Week 12|95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)|12 weeks|Intent to treat population without LOCF|||mm Hg||Standard Error|Least Squares Mean
2740528|NCT00947544|Secondary|Quality of Life Assessed by the SF-15 Questionnaire|"change from baseline to Month 12.~The SF 15 questionnaire consists of 15 questions that assess the following:~Physical functioning (5 questions)~Emotional functioning (4 questions)~Social functioning (3 questions)~School functioning (3 questions) Items were scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or a 3-point scale (0 [not at all], 2 [sometimes], or 4 [a lot] for the young child self-report). Items were reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score was 0-100 scale (averaged from each functional areas). In the 0-100 scale, 0 is the worst score and 100 is best score.~Improved quality of life was shown by increased total score from baseline to Month 12."|1 year|Patients who completed SF-15 at baseline and Month 12 both time in the safety extension period.|||score on a scale|total score from SF-15 report|Standard Deviation|Mean
2740529|NCT00947544|Secondary|Plasma PAGN AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||μg*h/mL AUC 0-24||Standard Deviation|Mean
2740533|NCT00947544|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA vs. HPN-100|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||percentage of sample|number of blood sample||Number
2740534|NCT00947544|Secondary|Average Ammonia Values on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug (Switch Over)|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||µmol/L||Standard Deviation|Mean
2740535|NCT00947544|Secondary|NH3 Cmax on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||μmol/L||Standard Deviation|Mean
2740536|NCT00947544|Secondary|Blood Ammonia Control|To evaluate control of blood ammonia by HPN-100 compared with NaPBA in pediatric patients with UCDs.|Day 7 (NaPBA) and Day 14 (HPN-100)||||μmol∙h/L||Standard Deviation|Mean
2740537|NCT00947544|Secondary|Number and Causes of Hyperammonemic Events (Safety Extension)|"Number of Subjects with at Least One Hyperammonemic Crisis.~Hyperammonemic crisis is defined as follows:~• Clinical symptoms associated with ammonia of ≥ 100 µmol/L"|1 year||||participants|||Number
2740538|NCT00947544|Primary|Rate of Adverse Events During the Switchover Part of the Study Rate of Adverse Events (Number of Participants Showing Adverse Events)|To evaluate the safety and PK characteristics of HPN-100 compared with sodium phenylbutyrate (NaPBA) in pediatric patients with urea cycle disorders (UCDs)|1 week on each treatment for a total of 2 week.||||participants|||Number
2740539|NCT00947531|Secondary|Combined Response, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 24|||||||
2740540|NCT00947531|Secondary|Change From Baseline in Clock-drawing Test|The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.|week 4, 12, 16, 24|||||||
2740541|NCT00947531|Secondary|Change From Baseline in Trail-making Test|The Trail-making test is a frequently used instrument for the assessment of executive function.|week 4, 12, 16, 24|||||||
2740542|NCT00947531|Secondary|Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)|The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.|week 4, 12, 16, 24|||||||
2740543|NCT00947531|Secondary|Change From Baseline in MMSE (Mini-Mental State Examination) Score|The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer's Disease. It evaluates orientation, registration, attention and calculation, recall and language.|week 4, 12, 16, 24|||||||
2740544|NCT00947531|Secondary|CIBIS+ (Clinicians Interview-Based Impression of Severity)|The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.|week 24|||||||
2740545|NCT00947531|Secondary|CIBIC+ Response|A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.|week 4, 12, 16, 24|||||||
2740546|NCT00947531|Secondary|CIBIC+ Sscore|The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.|week 4, 12, 16|||||||
2740547|NCT00947531|Secondary|Change From Baseline for Original ADAS-COG|The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.|week 4, 12, 16, 24|||||||
2740548|NCT00947531|Secondary|ADAS-COG+ Response|A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.|week 4, 12, 16, 24|||||||
2740549|NCT00947531|Secondary|Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)|The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.|week 4, 12, 16|||||||
2740550|NCT00947531|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram)||Baseline, week 4, 12, 16, 24||2009-09-30|09/2009||||
2740551|NCT00947531|Primary|CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24||week 24||2009-09-30|09/2009||||
2740552|NCT00947531|Primary|Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24|The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.|baseline and week 24|The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures.|||points on a scale||Standard Deviation|Mean
2740553|NCT00947518|Secondary|Incidence of Clinical and Culture Positive Sepsis|Infants with symptoms and/or signs suggestive of sepsis and a positive blood culture (with known pathogens and coagulase negative staphylococcus) were diagnosed to have culture positive sepsis; Those with negative cultures but with positive sepsis screen were classified as having clinical sepsis|First week of life||||Participants|||Count of Participants
2740554|NCT00947518|Primary|Number of Participants With Positive Skin Culture at Axilla|Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention|24 hours after intervention||||participants|||Number
2740555|NCT00947518|Primary|Skin Temperature at 30 Min After Intervention|Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes|at 30 min after intervention||||Degree Celsius||Standard Deviation|Mean
2740668|NCT00946322|Primary|Partner-reported PTSD Checklist|Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment|||units on a scale||Standard Deviation|Mean
2740556|NCT00947518|Primary|Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al|The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)|At 24 hours||||score on a scale||Full Range|Median
2740557|NCT00947505|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline|Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region|16 and 26 weeks||||change in terminal hair count||Standard Deviation|Mean
2740558|NCT00947427|Primary|C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo|"The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."|12 months||||nmol/L||95% Confidence Interval|Geometric Mean
2740559|NCT00947349|Secondary|CL/F,ss for BI 201335 ZW|apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2740560|NCT00947349|Secondary|Cavg for RBV|average plasma concentration (Cavg) of RBV|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740561|NCT00947349|Secondary|Cavg for BI 201335 ZW|average plasma concentration (Cavg) of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740562|NCT00947349|Secondary|Cmin,ss for RBV|Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740563|NCT00947349|Secondary|Cmin,ss for BI 201335 ZW|Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740564|NCT00947349|Secondary|t1/2,ss for BI 201335 ZW|terminal half-life of the analyte in plasma at steady state (t1/2,ss)|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||hour(s)||Geometric Coefficient of Variation|Geometric Mean
2740565|NCT00947349|Secondary|Tmax, ss for RBV|Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||hour(s)||Full Range|Median
2740566|NCT00947349|Secondary|Tmax, ss for BI 201335 ZW|Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||hour(s)||Full Range|Median
2740567|NCT00947349|Secondary|Tmax for RBV|Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS|||hour(s)||Full Range|Median
2740568|NCT00947349|Secondary|Tmax for BI 201335 ZW|Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS|||hour(s)||Full Range|Median
2740569|NCT00947349|Secondary|Cmax,ss of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740570|NCT00947349|Secondary|AUCτ,ss of RBV|Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2740571|NCT00947349|Secondary|Cmax of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740572|NCT00947349|Primary|Assessment of Tolerability in Triple Combination Therapy|An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.|||participants|||Number
2740573|NCT00947349|Secondary|AUCτ,1 for Ribavirin (RBV)|Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2766864|NCT00762034|Secondary|Number of Participants Who Received a Transfusion||Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2740574|NCT00947349|Secondary|Cmax,ss of BI 201335 ZW|Maximum concentration of BI 201335 ZW at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740575|NCT00947349|Secondary|AUCτ,ss of BI 201335 ZW|AUC at steady state after 4 weeks combination of the last dose|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2740576|NCT00947349|Secondary|Cmax of BI 201335 ZW|Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740577|NCT00947349|Secondary|AUCτ,1 for BI 201335 ZW|Area under the curve (AUC) concentration after the first dose of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2740578|NCT00947349|Secondary|Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV|An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.|44 weeks|TS|||participant(s)|||Number
2740579|NCT00947349|Secondary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.|44 weeks|TS|||participant(s)|||Number
2740580|NCT00947349|Secondary|Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV|Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|44 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.|||participant(s)|||Number
2740581|NCT00947349|Secondary|Sustained Virologic Response (SVR)|Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion|72 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740582|NCT00947349|Secondary|End of Treatment Response (ETR)|Number of patients with plasma HCV RNA level BLD at week 48|48 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740583|NCT00947349|Secondary|Complete Early Virological Response (cEVR)|Number of patients with plasma HCV RNA level BLD at Week 12|12 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740584|NCT00947349|Secondary|Early Virological Response (EVR)|Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12|12 Weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740585|NCT00947349|Secondary|Day 28 Virologic Response|Number of patients with HCV viral load reduction >= 2 log10 at Week 4|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740586|NCT00947349|Secondary|Change From Baseline in HCV Viral Load|Change form baseline in HCV viral load (log10) after 4 weeks|baseline and week 4|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||IU/mL||Standard Error|Mean
2740587|NCT00947349|Secondary|Rapid Virological Response (RVR)|Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740588|NCT00947349|Secondary|Week 4 Virological Response (W4VR)|Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740589|NCT00947349|Secondary|Week 2 Virological Response (W2VR)|Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))|2 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
2740590|NCT00947349|Primary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.|||participants|||Number
2740669|NCT00946322|Primary|Patient-reported PTSD Checklist|Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were included.|||units on a scale||Standard Deviation|Mean
2740591|NCT00947349|Primary|Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.|||participants|||Number
2740592|NCT00947310|Primary|Inappropriate ICD Therapy|First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)|Average of 1.4 years follow-up||||participants|||Number
2740593|NCT00947310|Secondary|Syncope|First episode of syncope|Average of 1.4 years follow-up||||participants|||Number
2740594|NCT00947310|Secondary|All-cause Mortality||Average 1.4 years of follow-up||||participants|||Number
2740595|NCT00947297|Secondary|Patient Satisfaction With HPN-100|Drug preference will be noted at week 3|Month 1 post dose|all available questionnaires|||% preferred HPN-100|||Number
2740596|NCT00947297|Secondary|Blood Ammonia Levels|Venous Ammonia levels over time|1 Year||||Umol/L||Standard Deviation|Mean
2740597|NCT00947297|Secondary|Number and Causes of Hyperammonemic Events|Number of hyperammonemic crises per patient|1 year||||hyperammonemic events||Standard Deviation|Mean
2740598|NCT00947297|Primary|Rate of Adverse Events (Number of Participants Who Experienced Any AE Considered Related to Study Drug)||1 year||||participants|||Number
2740599|NCT00947284|Primary|Change in Skin Sensitivity as Measured by a Visual Analog Scale|Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).|Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration|The planned model of skin irritation could not be reproduced on 3 enrolled participants, thus the investigator did not obtain outcome data.||||||
2740600|NCT00947271|Primary|Number of Sexual Partners, 12 Months Post Intervention|number of sexual partners in the past 3 months, assessed 12 months post intervention|12 months post intervention||||number of partners||Standard Error|Least Squares Mean
2740601|NCT00947271|Primary|Number of Sexual Partners, 9 Months Post Intervention|number of sexual partners in the past 3 months, assessed 9 months post intervention|9 months post intervention||||number of partners||Standard Error|Least Squares Mean
2740602|NCT00947271|Primary|Number of Sexual Partners, 6 Months Post Intervention|number of sexual partners reported in the past 3 months, assessed 6 months post intervention.|6 months post intervention||||number of partners||Standard Error|Least Squares Mean
2740603|NCT00947271|Secondary|Sexually Transmitted Infection Incidence|number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up|Measured throughout the 12 months post intervention|Participants who provided a urine sample for STI testing at any study follow up (3, 6, 9, or 12 months) OR who had STI testing performed at the STI clinic during the 12 months post intervention were included in these analyses|||participants diagnosed with any STI|||Number
2740604|NCT00947271|Primary|Number of Sexual Partners, 3 Months Post Intervention|number of sexual partners in the past 3 months, assessed 3 months post intervention|Measured after 3 months||||number of partners||Standard Error|Least Squares Mean
2740605|NCT00947219|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|baseline, 16 and 26 weeks||||hairs per cm^2|Participants|Standard Deviation|Mean
2740606|NCT00947167|Secondary|Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly|by CTCAE|AEs are assessed every cycle (every 3 wks)|whole cohort|||Participants|||Count of Participants
2740607|NCT00947167|Primary|Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)|RECIST v1.1 used|CT scans are done every 4 cycles (every 12 wks)|whole cohort|||Participants|||Count of Participants
2740608|NCT00947154|Secondary|Clinical Global Impressions Improvement (CGI-I)|The CGI-I is a clinician rated scale ranging from 0 (not assessed) to 7 (very much worse), with intermediate scores of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse). The clinician is rating the overall change in the patient's clinical condition.|At week 8|11 participants. 1 participant lost to follow up after week 1|||percentage completers with score 1 or 2|||Number
2740609|NCT00947154|Primary|Mass General Hair Pulling Scale, Actual Pulling Subscale|Sum of scores for items 4, 5 and 6 from the Mass General Hair Pulling Scale (Frequency of Pulling, Attempts to Resist Pulling, Control Over Hair Pulling). Score can range from 0 to 12; higher scores indicate more severe hair pulling.|change from baseline to end of week 8|11 participants. 1 participant was lost to follow-up after week 1.|||units on a scale||Standard Deviation|Mean
2740610|NCT00947154|Secondary|CGI-I Score of 1 or 2 (Very Much or Much Improved)|CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better.|At week 8|11 of the 12 subjects initially enrolled. One subject was lost to follow-up after the baseline visit.|||participants|||Number
2740611|NCT00947154|Primary|Mass General Hair Pulling Scale|A brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess frequency and intensity of urges to pull, ability to control the urges, frequency of pulling, attempts to resist pulling, success in resisting, and associated distress. Statistical analyses indicate that the seven items form a homogenous scale for the measurement of severity in trichotillomania. Higher scores indicate greater severity of hair pulling. Total score can range from 0 to 28.|Change from baseline to week 8|11 of the 12 subjects initially enrolled. One was lost to follow-up after baseline visit.|||units on a scale||Standard Deviation|Mean
2740671|NCT00946322|Secondary|Patient-reported Beck Depression Inventory - II (BDI-II)|Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.|Pre- to post-treatment|Participants completing the BDI-II at pre- and post-treatment were analyzed|||units on a scale||Standard Deviation|Mean
2740612|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 0 up to Year 10|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available throughout the study.|||Subjects|||Number
2740613|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 (Year 9) to the Month 120 (Year 10) visit|The analysis was based on the Total Vaccinated cohort at Year 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 10.|||Subjects|||Number
2740614|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 (Year 8) to the Month 108 (Year 9) visit|The analysis was based on the Total Vaccinated cohort at Year 9, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 9.|||Subjects|||Number
2740615|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 (Year 7) to the Month 96 (Year 8) visit|The analysis was based on the Total Vaccinated cohort at Year 8, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 8.|||Subjects|||Number
2740616|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 (Year 6) visit to Month 84 (Year 7) visit|The analysis was based on the Total Vaccinated cohort at Year 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 7.|||Subjects|||Number
2740617|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit|The analysis was based on the Total Vaccinated cohort at Year 6, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 6.|||Subjects|||Number
2740618|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5)|The analysis was based on the Total Vaccinated cohort at Year 5, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 5.|||Subjects|||Number
2740619|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.|||µg/mL||95% Confidence Interval|Geometric Mean
2740620|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the Total Vaccinated Cohort at Years 5, 6 and 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.|||µg/mL||95% Confidence Interval|Geometric Mean
2740621|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL)|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||µg/mL||95% Confidence Interval|Geometric Mean
2740622|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||µg/mL||95% Confidence Interval|Geometric Mean
2740889|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||participants|||Number
2740623|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2740624|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2740625|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2740626|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2740627|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.|||Subjects|||Number
2740628|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.|||Subjects|||Number
2740629|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2740630|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2740631|NCT00947011|Secondary|Peripheral Glucose Utilization and Peripheral Glucagon Release||one year|Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.||||||
2740632|NCT00947011|Primary|Insulin Release Rate and Hepatic Glucose Release||One year|Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.||||||
2740633|NCT00946998|Secondary|Serious Adverse Events During the 12 Week Study Duration.|death, dialysis initiation, hospitalizations, or bleeding requiring transfusion|during 12 week study duration||||Participants|||Count of Participants
2740634|NCT00946998|Secondary|Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health.|Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life.|baseline to 12 weeks||||units on a scale||Inter-Quartile Range|Median
2740635|NCT00946998|Secondary|Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale|Each item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40.|baseline to 12 weeks||||units on a scale||95% Confidence Interval|Mean
2740636|NCT00946998|Secondary|Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5|The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.|baseline to 12 weeks||||participants|||Number
2740637|NCT00946998|Primary|Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.|The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.|baseline to 12 weeks||||units on a scale||95% Confidence Interval|Mean
2740670|NCT00946322|Secondary|Patient-reported Dyadic Adjustment Scale|Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed|||units on a scale||Standard Deviation|Mean
2740638|NCT00946985|Primary|Time to Relapse During Relapse Prevention Phase|Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.|24 months|The analysis population was to include all randomized patients who took at least one dose of study medication (ITT population). However, due to early study termination, only 2 patients were randomized and they did not have sufficient follow up. Hence the planned efficacy analysis could not be carried out.||||||
2740639|NCT00946920|Secondary|Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline|"IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and a score of 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia."|At baseline, 1 month, 4 months, 7 months and 13 months|FAS.|||units on a scale||Standard Deviation|Mean
2740640|NCT00946920|Secondary|Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline|The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.|At baseline, 10 months and 13 months|FAS.|||units on a scale||Standard Deviation|Mean
2740641|NCT00946920|Secondary|Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time|Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.|||percent change||Standard Deviation|Mean
2740642|NCT00946920|Secondary|Serum Levels of Testosterone Over Time|Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.|||ng/mL||Full Range|Median
2740643|NCT00946920|Primary|Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin|This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.|Day 3 to Day 364|FAS.|||percentage of participants||95% Confidence Interval|Number
2740644|NCT00946920|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix|This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.|From Day 28 to Day 364|FAS.|||percentage of participants||95% Confidence Interval|Number
2740645|NCT00946881|Secondary|Pharmacokinetic Parameters -T1/2|For each dose group, several pharmacokinetics parameters have been calculated.|T0, 5 min,10 min, 4 h, 8 h, post dose|Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.|||hours||Standard Deviation|Mean
2740646|NCT00946881|Secondary|Pharmacokinetic Parameters-Tmax|For each dose group, several pharmacokinetics parameters have been calculated.|T0, 5 min,10 min, 4 h, 8 h, post dose|Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.|||hours||Standard Deviation|Mean
2740647|NCT00946881|Secondary|International Prostate Symptom Score (IPSS) Results|The International Prostate Symptom Score (IPSS) is a 7 questions patients auto-questionnaire about urinary symptoms. the possible scores range are 0 to 35 . Best score is 0 worst score is 35|Month 1, Month 3 , Month 6 , Month 12|IPSS results|||units on a scale||Standard Deviation|Mean
2740648|NCT00946881|Secondary|International Index of Erectile Functions (IIEF) Results|The International Index of Erectile Functions questionnaire is 15 questions patients auto questionnaire. The results presented are those of the erectile function domain which comprise 6 questions. Possible scores range is 1 to 30 . Best score is 30, worst score is 1.|Month 1-Month 3- Month 6- Month 12||||units on a scale||Standard Deviation|Mean
2740649|NCT00946881|Secondary|Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI|"The adjusted prostate necrosis percentage was defined as follows:~The Day 7 necrosis percentage is the proportion, expressed in %, of Day 7 prostate necrosis volume by planimetry in the treated lobe compared with half the prostate volume by planimetry, considering the average between the baseline volume and Day 7 volume;"|Day 7||||percentage of prostatic necrosis||Standard Deviation|Mean
2740650|NCT00946881|Secondary|Pharmacokinetic Parameters-Cmax|For each dose group, several pharmacokinetics parameters have been calculated.|T0, 5 min,10 min, 4 h, 8 h, post dose|Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.|||ng/mL||Standard Deviation|Mean
2740651|NCT00946881|Primary|Prostate Biopsies|Number of patients who had a negative biopsy at Month-6|Month-6||||Participants|||Count of Participants
2740652|NCT00946881|Primary|Prostate Biopsy|"Arm/Group Title:~WST 11(TOOKAD® Soluble) Arm/Group Description To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe"|Month 6||||participants|||Number
2740653|NCT00946712|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity.|Limited to eligible patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.|||Participants|||Count of Participants
2740654|NCT00946712|Secondary|Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.|Eligible patients with baseline measurable disease are included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2740655|NCT00946712|Secondary|Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.|Eligible EGFR FISH positive patients with baseline measurable disease are included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2740656|NCT00946712|Secondary|PFS of the Entire Study Population by Centralized Review and by Institutional Review|From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.|||||||
2740657|NCT00946712|Secondary|PFS of EGFR FISH-positive Patients by Centralized Review|From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.|||||||
2740658|NCT00946712|Secondary|OS of EGFR FISH-positive Patients by Centralized Review|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years|||||||
2740659|NCT00946712|Primary|Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review|From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.|Eligible patients with EGFR FISH positive are included in the analysis.|||months||95% Confidence Interval|Median
2740660|NCT00946712|Primary|Overall Survival (OS) in the Entire Study Population|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years|All eligible patients are included in the analysis.|||months||95% Confidence Interval|Median
2740661|NCT00946530|Secondary|WASO (Wake After Sleep Onset)|WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.|2 weeks||||units on a scale (minutes)||Standard Deviation|Mean
2740662|NCT00946530|Primary|Total Sleep Time|The amount of actual sleep time in a sleep episode.|2 weeks|dyads consisting of 1 AD patient and 1 caregiver|||units on a scale (minutes)||Standard Deviation|Mean
2740663|NCT00946478|Primary|Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD|Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo|3 weeks||||delta-delta ct units on PCR||Standard Error|Mean
2740664|NCT00946348|Secondary|To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.||Over 8 hours|||||||
2740665|NCT00946348|Primary|fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).|Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.|Measures were acquired at peak THC level for each of the two drugs up to 4 hours.||||Z score||Standard Deviation|Mean
2740666|NCT00946322|Secondary|Partner-reported Dyadic Adjustment Scale|Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2740667|NCT00946322|Secondary|Partner-reported Beck Depression Inventory - II|Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing the pre- and post-treatment assessment were included|||units on a scale||Standard Deviation|Mean
2740672|NCT00946322|Primary|Percentage Days of Heavy Drinking|Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans' drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were analyzed|||percentage of days of heavy drinking||Standard Deviation|Mean
2740673|NCT00946322|Primary|Clinician-administered PTSD Scale (CAPS)|Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.|Pre- to post-treatment (~20 weeks)|Participants completing both pre- and post-treatment assessments were analyzed.|||units on a scale||Standard Deviation|Mean
2740674|NCT00946309|Primary|3-alpha-diol Gluconate Levels|Change in serum 3-alpha-diol gluconate(3α-DG) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants|||ng/mL||Standard Deviation|Mean
2740675|NCT00946309|Primary|Testosterone Levels|Change in testosterone (T) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants|||ng/dL||Standard Deviation|Mean
2740676|NCT00946309|Primary|DHT Levels|Change in serum dihydrotestosterone (DHT) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants|||pg/mL||Standard Deviation|Mean
2740677|NCT00946309|Primary|DNA Oxidation|Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels|Five weeks|Outcome data were not collected due to budget restrictions||||||
2740678|NCT00946309|Primary|Lipid Oxidation|Blood F2 Isoprostane levels|Baseline and 5 weeks|Outcome data were not collected due to budget restrictions||||||
2740679|NCT00946309|Primary|Gene Expression of Phase II Enzymes|Change in Phase II enzyme expression|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 20 participants|||-fold change in expression||Standard Deviation|Mean
2740680|NCT00946296|Primary|Blood Loss During Surgery|Blood loss in milliliters during surgery.|up to 162 minutes||||mL||Standard Deviation|Mean
2740681|NCT00946270|Primary|Number of Participants With Best Overall Response|Primary endpoint is best overall response. An evaluable subject classified as a treatment success for the primary endpoint if the subject's best overall response is clinical improvement (CI) as determined by International Working Group Criteria over the first 6 cycles of study treatment. International Working Group (IWG) consensus criteria for treatment response in myelofibrosis - Clinical improvement (CI) in anemia 1/ A minimum 20g/L increase in hemoglobin level or 2. becoming transfusion independent for at least 8 week duration.|6 months||||Participants|||Count of Participants
2740682|NCT00946192|Secondary|Change in Total Volumetric Bone Mineral Density (Tibia)|Change in total volumetric bone density at the tibia with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes|12 months||||mg HA/cm^3||Standard Error|Mean
2740683|NCT00946192|Primary|Change in Lumbar Bone Mineral Density|Change in bone density with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes|12 months||||g/cm^2||Standard Error|Mean
2740684|NCT00946153|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time from the date of registration until the date of death.|From day of registration to the day of death (approximately 6.1 years)|PPS included all participants in the FAS who showed >=75% cumulative treatment compliance, had a baseline and post baseline tumor response assessment, and completed at least 2 cycles or discontinued during the 2 cycles due to PD or death.|||months||95% Confidence Interval|Median
2740685|NCT00946153|Secondary|Phase 2: Disease Control Rate (DCR) by Independent Review Assessment|DCR was measured by mRECIST and defined as CR which was defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.|Weeks 8 and 16|PPS included all participants in the FAS showed >=75% cumulative treatment compliance, had a baseline and post baseline tumor response assessment, and completed at least 2 cycles or discontinued during the 2 cycles due to PD or death.|||percentage of participant||95% Confidence Interval|Number
2740686|NCT00946153|Secondary|Phase 2: Objective Response Rate (ORR) by Independent Review Assessment|ORR was defined as the percentage of participants who achieved a tumor response measured by mRECIST of CR defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.|From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)|PPS included all participants in the FAS who showed >=75% cumulative treatment compliance, had a baseline and post baseline tumor response assessment, and completed at least 2 cycles or discontinued during the 2 cycles due to PD or death.|||percentage of participants||95% Confidence Interval|Number
2740687|NCT00946153|Secondary|Phase 2: Progression-free Survival (PFS) by Independent Review Assessment|PFS was defined as the time from the date of registration until the date when PD was first confirmed or death (whichever occurred first) as determined by mRECIST and PD was defined as at least a 20% increase in the sum of long diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.|From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)|PPS included all participants in the FAS who showed >=75% cumulative treatment compliance, had a baseline and post baseline tumor response assessment, and completed at least 2 cycles or discontinued during the 2 cycles due to PD or death.|||months||95% Confidence Interval|Median
2740697|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).|||participants|||Number
2740688|NCT00946153|Secondary|Phase 1: Disease Control Rate (DCR) by Investigator Assessment|DCR was measured by RECIST 1.1 and defined as CR which was defined as disappearance of all target lesions (a short diameter was <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.|Up to Week 16|EAS included participants who received at least 1 dose of lenvatinib, and had at least 1 postbaseline efficacy evaluation.|||percentage of participants|||Number
2740689|NCT00946153|Secondary|Phase 1: Objective Response Rate (ORR) by Investigator Assessment|ORR was defined as the percentage of participants who achieved a tumor response measured by RECIST 1.1 of CR defined as disappearance of all target lesions (a short diameter is less than (<)10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.|From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)|EAS included participants who received at least 1 dose of lenvatinib, and had at least 1 postbaseline efficacy evaluation.|||percentage of participants|||Number
2740690|NCT00946153|Secondary|Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment|"BOR was performed using RECIST1.1 and was measured as complete response (CR) defined as when an overall response of CR was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of CR was confirmed and the BOR established as CR was regarded as the CR confirmed date), partial response (PR) defined as when the overall response of PR or better (CR or PR) was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of PR was confirmed and the BOR established as PR will be regarded as the PR confirmed date), PD defined as when the BOR was neither CR, PR, or stable disease (SD), and the overall response was PD, SD defined as when the BOR obtained was neither CR nor PR, but no PD from the initial administration to the end of Cycle 2 and the overall response of SD or better occurred at least once and not evaluable (NE) was when the overall response was NE in all cases."|Every 8 weeks (approximately up to 18.4 months)|Efficacy analysis set (EAS) included all participants who received at least 1 dose of lenvatinib, and had at least 1 postbaseline efficacy evaluation.|||Participants|||Count of Participants
2740691|NCT00946153|Primary|Phase 2: Time to Progression (TTP) by Independent Review Assessment|TTP was defined as the time from the date of registration to the date when progressive disease (PD) was first confirmed. PD was evaluated according to modified response evaluation criteria in solid tumors (mRECIST) by an independent imaging review. PD was defined as at least a 20 percent (%) increase in the sum of long diameter (LD) of target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 millimeter (mm) (including new lesions).|From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)|Per protocol set (PPS) included all participants in full analysis set (FAS), who showed greater than or equal to (>=) 75% cumulative treatment compliance, had a baseline and post baseline tumor response assessment, and completed at least 2 cycles or discontinued during the 2 cycles due to PD or death.|||months||95% Confidence Interval|Median
2740692|NCT00946153|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib|The MTD was defined as the highest dose level at which no more than 1 of 6 participants had a dose limiting toxicities (DLT). DLT was defined as any of the following events: grade 4 or higher hematologic toxicity or grade 3 thrombocytopenia that required blood transfusion, grade 3 or higher nonhematologic toxicity, grade 4 hypertension uncontrolled by antihypertensive drug(s), aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than (>) 10.0*upper limit of normal (ULN), proteinuria 4+ by urine dipstick, proteinuria 3+ by urine dipstick was to be monitored by 24-hour urine collection, proteinuria >3.5 gram (g) for 24 hours, diarrhea/vomiting/nausea of grade 3 or higher that was uncontrollable despite maximal supportive therapies and abnormal clinical laboratory values that required no treatment, grade 3 proteinuria by dipstick, diarrhea/vomiting/nausea that was managed with supportive therapies were not considered as DLT.|Up to 28 days (Cycle1)|Safety analysis set (SAS) included all participants who received at least 1 dose of lenvatinib, and had at least 1 post baseline safety evaluation.|||milligram (mg)|||Number
2740693|NCT00946114|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline up to 116 Weeks|Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication.|||participants|||Number
2740694|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).|||titer||Full Range|Geometric Mean
2740695|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).|||titer||Full Range|Geometric Mean
2740696|NCT00946101|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).|||titer||Full Range|Geometric Mean
2740698|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).|||participants|||Number
2740699|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).|||participants|||Number
2740700|NCT00946101|Secondary|Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740701|NCT00946101|Secondary|Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||Participants|||Number
2740702|NCT00946101|Secondary|Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
2740703|NCT00946101|Secondary|Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
2740704|NCT00946101|Secondary|Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740705|NCT00946101|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740706|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
2740707|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
2740708|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).|||participants|||Number
2740709|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
2740710|NCT00946101|Secondary|Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
2740711|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).|||participants|||Number
2740712|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740713|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740714|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).|||participants|||Number
2740715|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740716|NCT00946101|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740717|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1|Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.|Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).|||participants|||Number
2740718|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).|||participants|||Number
2740719|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).|||participants|||Number
2740720|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).|||participants|||Number
2740721|NCT00946101|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.|Days 1- 8|The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
2740722|NCT00946088|Secondary|Number of Days Delay of Delivery|Number of days from intervention to delivery|Up to the time of delivery|exact delivery data unavailable for one term participant|||days||Full Range|Median
2740723|NCT00946088|Secondary|Neonatal Congenital Abnormalities||Up to the time of neonatal discharge from the delivery hospital||||Neonates|||Number
2740724|NCT00946088|Secondary|Neonatal Mortality||Up to 28 days after neonatal birth||||Participants|||Count of Participants
2740725|NCT00946088|Secondary|Neonatal Morbidity||Up to 28 days after neonatal birth||||Participants|||Count of Participants
2740726|NCT00946088|Secondary|Neonatal Intensive Care Unit (NICU) Admission||At time of neonatal discharge||||Participants|||Count of Participants
2740727|NCT00946088|Secondary|Birthweight|Newborn birthweight in grams|At the time of newborn birth||||grams||Full Range|Mean
2740735|NCT00946023|Secondary|Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD)|Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
2740736|NCT00946023|Secondary|Non-relapse Mortality|Percentage of participants who died due to BMT-related reasons.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
2740737|NCT00946023|Secondary|Relapse|Percentage of participants alive with relapse or disease progression.|2 years post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
2740738|NCT00946023|Secondary|Relapse|Percentage of participants alive with relapse or disease progression.|1 year post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
2740739|NCT00946023|Secondary|Overall Survival|Percentage of participants alive.|2 years post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
2740740|NCT00946023|Secondary|Overall Survival|Percentage of participants alive.|1 year post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
2740741|NCT00946023|Secondary|Progression-free Survival|Percentage of participants alive with and without relapse.|2 years post-intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
2740742|NCT00946023|Primary|Progression-free Survival|Percentage of participants alive and without relapse or disease progression.|1 year post-intervention|"Populations were analyzed as follows:~All participants~Recipients of haploidentical donors (69 participants)~Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
2740743|NCT00945958|Secondary|Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)|From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured|24 weeks|From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated|||mm Hg||Standard Deviation|Mean
2740744|NCT00945958|Primary|Number of Subjects With AEs|Subjects with treatment emergent adverse events|24 weeks||||participants|||Number
2740745|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey|Self-reported questionnaire with 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740746|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)|Patients rate their health state in 5 domains: mobility, self-care, usual activities, pain, and mood. Score between 1-3 is generated for each domain which is mapped to single index score. Index ranges between 0-1; higher scores indicate better health perceived by patient. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740747|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)|BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0-20. Total score = sum of all factor scores minus vigor score. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740748|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version|An 11-item questionnaire to individually and jointly assess intermittent and constant pain. Questions assess intensity and impact of pain on activity and emotion. Each item is scored from 0 to 4; higher values indicate higher severity. Total Pain score ranges from 0-44. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740749|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740750|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score|Interference scores range from 0 (does not interfere) to 10 (completely interferes) on 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Total score ranges from 0-70. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740751|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale|Self-reported scale measuring pain severity. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Four questions assess worst pain, least pain, and average pain in the past 24 hours, and pain right now. Total score ranges from 0-40. Due to the nature of a study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740752|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score|The WOMAC index (pain, stiffness, physical function subscales) was completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
2740753|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||participants||Standard Deviation|Mean
2740754|NCT00945945|Secondary|Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale|"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through 13 weeks|All randomized participants.|||participants|||Number
2740755|NCT00945945|Primary|"Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented.|Baseline, 13 weeks|Number of randomized participants with a non-missing baseline and BOCF endpoint.|||units on a scale||Standard Deviation|Mean
2740756|NCT00945906|Secondary|Number of Bleeding Episodes|Number of bleeding episodes at any time after the first infusion in the study.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||Episodes|||Number
2740757|NCT00945906|Secondary|Number of Subjects With at Least One Bleeding Episode|Number of subjects with at least one bleeding episode at any time after the first infusion in the study, and the number of subjects with at least one bleeding episode requiring Factor XIII treatment.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||participants|||Number
2740758|NCT00945906|Secondary|FXIII Concentration|Trough Factor XIII concentration.|Before the first infusion, at 24 and 48 weeks after the first infusion, and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||Units/mL||Standard Deviation|Mean
2740759|NCT00945906|Secondary|FXIII Antibody Testing|Number of participants with serum Factor XIII antibodies.|Before the first infusion, then every 48 weeks, at the end-of-study (or withdrawal) visit and after a bleeding episode requiring treatment with a Factor XIII -containing product.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||participants|||Number
2740760|NCT00945906|Secondary|Hematology and Chemistry Testing|Number of participants with treatment-emergent clinically significant hematology and/or chemistry laboratory parameter values.|After the first infusion and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||participants|||Number
2740804|NCT00945659|Secondary|Diabetes Family Responsibility Questionnaire-Adolescent|Adolescent's self-ratings of their degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate greater adolescent responsibility for diabetes care.|Baserline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2768904|NCT00746733|Secondary|Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population|||bpm||Standard Deviation|Mean
2740761|NCT00945906|Primary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study. Treatment related AEs are events whose relationship to study treatment is related, or possibly related, in the opinion of the investigator. AEs with missing relationship are considered related to treatment.|||participants|||Number
2740762|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.|||Titer||Full Range|Geometric Mean
2740763|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Titer||Full Range|Geometric Mean
2740764|NCT00945893|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Titer||Full Range|Geometric Mean
2740765|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.|||Participants|||Number
2740766|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
2740767|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
2740768|NCT00945893|Secondary|Number of Participants With NOCDs Through 180 Days Post Final Dose.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740769|NCT00945893|Secondary|Number of Participants With SAEs Through 180 Days Post Final Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740770|NCT00945893|Secondary|Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.|||Participants|||Number
2740771|NCT00945893|Secondary|Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
2740805|NCT00945659|Secondary|Diabetes Family Conflict Scale-Parent|Parents' ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more family conflict around diabetes.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740772|NCT00945893|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740773|NCT00945893|Secondary|Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740774|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
2740775|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
2740776|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.|||Participants|||Number
2740777|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
2740778|NCT00945893|Secondary|Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
2740779|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2||Days 29-36|The Safety Population for solicited symptoms dose 2 was defined as all participants who received Dose 2, had any follow-up for safety and had solicited symptom data available during the reporting period.|||Participants|||Number
2740780|NCT00945893|Secondary|Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740781|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740782|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.|||Participants|||Number
2740783|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.||Days 1-8|The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740784|NCT00945893|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1||Days 1-8|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740785|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1|Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache.|Days 1-8|The Safety population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.|||Participants|||Number
2740786|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.|||Participants|||Number
2740787|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 29|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
2740806|NCT00945659|Secondary|Diabetes Family Conflict Scale-Adolescent|Adolescent ratings of degree of diabetes-related family conflict. Score range 19-57. Higher scores indicate more frequent family conflict around diabetes.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2776144|NCT00699660|Secondary|Patient Satisfaction|Mean score on satisfaction survey rating scale from 1 to 5 (higher)|post-exam, same day||||units on a scale||Standard Deviation|Mean
2740788|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 15|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
2740789|NCT00945893|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses • H0 (null): rate difference ≥ 10% • HA (alternative): rate difference < 10%|Days 1-8|Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
2740790|NCT00945854|Secondary|Postprandial Plasma Lipid Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of triglyceride response reported as average mean postprandial increment.|12 weeks||||mg/dlx3hrs||Standard Deviation|Mean
2740791|NCT00945854|Secondary|Postprandial Insulin Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of plasma insulin response reported as average mean postprandial increment.|12 weeks||||(microU/mlx3hrs)||Standard Deviation|Mean
2740792|NCT00945854|Primary|Insulin Sensitivity (Si)|Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si|12 weeks||||104xmin-1/microU/ml||Standard Error|Mean
2740793|NCT00945815|Primary|Complete Remission|Complete remission (CR) is defined as: <5% marrow aspirate blasts. Blasts can be >=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils >= 1000/mcl; platelets >100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be <=100,000/mcl and/or ANC may be <1,000/mcl.|After induction therapy was completed (1 or 2 months)|Eligible patients who began protocol therapy.|||percentage of participants||95% Confidence Interval|Number
2740794|NCT00945815|Secondary|Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.|||Participants|||Number
2740795|NCT00945750|Secondary|Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL||95% Confidence Interval|Geometric Mean
2740796|NCT00945750|Secondary|AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL hr||95% Confidence Interval|Geometric Mean
2740797|NCT00945750|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL||95% Confidence Interval|Geometric Mean
2740798|NCT00945750|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL hr||95% Confidence Interval|Geometric Mean
2740799|NCT00945659|Secondary|Hypoglycemia Fear Survey-Parent|Parental worry and behavior related to apprehension of low BG events. Score range 24-72. Higher scores indicate greater parental fear and avoidance of hypoglycemia.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740800|NCT00945659|Secondary|Hypoglycemia Fear Survey-Adolescent|Adolescent worry and behavior related to apprehension of low BG episodes. Score range 24-72. Higher scores indicate greater fear and avoidance of hypoglycemia|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740801|NCT00945659|Secondary|Diabetes Self Management Profile-Parent|Parent report of adolescent's diabetes self-management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740802|NCT00945659|Secondary|Diabetes Self Management Profile-Adolescent|Adolescent self-report of diabetes management behaviors. Score range 0-86. Higher scores indicate more meticulous diabetes treatment adherence.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740803|NCT00945659|Secondary|Diabetes Family Responsibility Questionnaire-Parent|Parent ratings of adolescent's degree of responsibility for 38 diabetes tasks. Score range 0-76. Lower scores indicate great adolescent responsibility for diabetes care tasks.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740807|NCT00945659|Secondary|Blood Glucose Monitoring Communication Questionnaire-Parents|Parents perspectives of communication with adolescent around blood glucose monitoring and results. Score range 8-24. Higher scores signify more negative communication about BG results.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740808|NCT00945659|Secondary|Blood Glucose Monitoring Communication Questionnaire-Adolescent|Adolescent report of communication with parents about blood glucose monitoring and results. Range 8-24. Higher scores indicate more negative communication about BG results.|Baseline, 3, 6, 9 months||||units on a scale||Standard Deviation|Mean
2740809|NCT00945659|Secondary|Diabetes Technology Questionnaire-Parents' Total Scores on DTQ Current Items|Parents' ratings of impact and satisfaction with the diabetes devices currently in use (e.g. pump, meter, CGM etc.) Score range from 30-150. Higher score signify greater satisfaction and impact.|Baseline, 3, 6, 9 months||||Total scores||Standard Deviation|Mean
2740810|NCT00945659|Secondary|Diabetes Technology Questionnaire-Adolescents|Adolescent's total score on the DTQ-Current items. Range 30-150. Higher scores indicate more favorable satisfaction with and impact of the package of diabetes technology (e.g. pump, meter, CGM, etc.) in use by the patient during the prior 3 months.|Baseline, 3 6, 9 months||||Total score||Standard Deviation|Mean
2740811|NCT00945659|Primary|Glycated Hemoglobin (HbA1c)|Glycated hemoglobin (HbA1c) expressed as a percentage of hemoglobin molecules bound to glucose.|Baseline, 3, 6, 9 months||||percentage of hemoglobin molecules||Standard Deviation|Mean
2740812|NCT00945594|Secondary|Visual Analog Pain Scale|The Visual analog pain scale measures patient-reported pain levels from 0-10, with 0 being no pain reported and 10 being the highest level of pain reported. In this study, researchers compared pain levels between females who had rigid and flexible cystoscopies.|Immediately after procedure||||units on a scale||Full Range|Median
2740813|NCT00945594|Primary|Duration of Post-procedure Complications|Duration of post-procedure complications, surveyed 1 week post procedure|1 week after procedure||||minutes||Standard Deviation|Mean
2740814|NCT00945594|Primary|Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.|"Post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. Patients were asked to report frequency or urgency as a yes or no"|1 week after procedure|A total of 42 participants and 43 participants were analyzed from each group, respectively. Some participants may have reported multiple symptoms, which is why the numbers below may exceed to total number of participants analyzed.|||participants|||Number
2740815|NCT00945555|Secondary|Percentage of Participants Who Had a Treatment Modification||Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants who had a treatment modification at any time point. n=number of participants who had data available at that specific time point.|||percentage of participants|||Number
2740816|NCT00945555|Secondary|Percentage Survivors||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with data available.|||percentage of participants|||Number
2740817|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined at End of Treatment||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment.|||percentage of participants|||Number
2740818|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined on Day 4||Day 4|All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.|||percentage of participants|||Number
2740819|NCT00945555|Secondary|Mean Neutrophil Count||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with available data. n=number of participants with data available at that time point.|||neutrophils per cubic millimeter||Standard Deviation|Mean
2740820|NCT00945555|Secondary|Mean Body Temperature||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. n=number of participants with available data at that time point.|||Degree Celsius||Standard Deviation|Mean
2740821|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted||Baseline|All participants enrolled in the study who received treatment for febrile neutropenia. Number of participants analyzed=number of participants who received an antibacterial drug for the treatment of febrile neutropenia. Participants may be counted more than once because they may have received more than one antibacterial agent.|||percentage of participants|||Number
2740822|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical||Baseline|All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.|||percentage of participants|||Number
2740823|NCT00945477|Secondary|Number Adverse Events, Grades 1-5 Using NCI-CTCAE v 3.0|Safety was evaluated by documentation of Adverse Events (AEs), by assessment of clinical laboratory findings, and by physicial examination, including measurement of vital signs and weight in all eleven subjects.|0-12 weeks|The adverse events for all participants enrolled were evaluated by documentation of Adverse Events (AEs)Grades 1-5 using NCI-CTCAE v 3.0|||Adverse events Grade 1-5|||Number
2740824|NCT00945477|Primary|Response Rate at 12 Weeks|Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline|12 weeks|Five subjects completed the 12 week treatment requirement.|||participants|||Number
2740825|NCT00945334|Secondary|Change in Methane From Baseline|"Methane output was reported as methane in parts per million (ppm) on breath test:~Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration."|Baseline (Day 0) and Final Visit (Day 44)|Change in breath test methane gas levels: baseline breath test minus final breath test measurement.|||parts per million||Standard Deviation|Median
2740890|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR||Standard Deviation|Mean
2740826|NCT00945334|Primary|Severity of Constipation in Each Arm at Week 1 After Completion of Therapy|"Visual analog scale (VAS) score for constipation:~Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms)."|1 year||||units on a scale||Standard Deviation|Mean
2740827|NCT00945321|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.|||ng/mL||Standard Error|Mean
2740828|NCT00945321|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.|||ng•hr/mL||Standard Deviation|Mean
2740829|NCT00945295|Secondary|Length of Time to Meet Re-injection Criteria and the Number of Participants That do Not Meet Re-injection Criteria Prior to Completion of the Study.||6 Weeks||||number|||Number
2740830|NCT00945295|Primary|The Maximum Change in Fugl-Meyer Upper Extremity Score From the Baseline Exam to Any Post Injection Visit in Each Treatment Arm. Comparison of the Difference Scores Between the Two Groups Will be Considered Significant at p < 0.05.||6 Weeks||||difference|||Number
2740831|NCT00945282|Secondary|PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality|Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. Data for Ctau on Day 1 is presented for concentration at 24 hours post-dose on Day 1.|(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7|PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740832|NCT00945282|Secondary|PK Data of Day 1 AUC(0-inf) and Day 7 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality|Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. The dose proportionality effects of IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg, following repeat dose administration on Day 7 for the PK parameter AUC(0-tau) has been reported.|(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7|PK population.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740833|NCT00945282|Secondary|Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7|The pre-dose GSK2248761 steady state concentration, following repeated dose administration from Day 2 through Day 7 was assessed. Serial dose sampling was done on each day of Day 2, 3, 4, 5 and Day 6 and for Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose), before the administration of the study drug daily.|Day 7 (Pre - dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) and Days 2, 3, 4. 5 and 6: pre-dose only|PK population.|||ng/mL||90% Confidence Interval|Mean
2740834|NCT00945282|Secondary|Change From Baseline in Reverse Transcriptase Sequences of HIV-1 at Day 8|"None of the participants had non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations at codons 90, 98, 100, 101, 103, 106, 108, 138, 179, 181, 188, 190, 225, or 230 at either Day 1 or Day 8. No mutation selected by GSK2248761 in vitro was observed for any participant at either Day 1 or Day 8. This data for Change from baseline in reverse transcriptase sequences of HIV-1 at Day 8 not collected."|Baseline (Screening) and Day 8|"ITT population. Data not collected for Change from baseline reverse transcriptase sequence"||||||
2740835|NCT00945282|Secondary|Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration|The accumulation ratio is based on the parameters, Cmax, AUC(0-tau), AUC(0-24), C(tau), C24, AND AUC(0-inf). The accumulation ratio Ro was the ratio of AUC(0-tau) on Day 7 to that of AUC(0-24) on Day 1; the accumulation ratio R (Cmax) was the ratio of Cmax on Day 7 to that of Cmax on Day 1; the accumulation ratio R(Ctau) was the ratio of Ctau on Day 7 to the ratio of C24 on Day 1 and the Time Invariance Ratio Rs was defined as the ratio of AUC(0-tau) on Day 7 to that of AUC(0-inf) on Day 1. The ratio has been reported as number.|(Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) on Day 1 and Day 7|PK population.|||ratio||90% Confidence Interval|Number
2740836|NCT00945282|Secondary|Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8|Data for CD4+ and CD8+ cells was collected at Screening, Day 1 and Day 8. The percent change from baseline was reported at Day 1 and Day 8. Baseline was defined as Screening. The percent change from baseline was calculated as post-randomization value minus the baseline value.|Baseline (Screening), Day 1 and Day 8|ITT population.|||Percent change||Standard Deviation|Mean
2740837|NCT00945282|Primary|Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8.|Whole venous blood samples were obtained from each participant for the analysis of lymphocyte subsets by flow cytometry (total lymphocyte counts, percentage, CD4+ cell counts, and CD8+ cell counts) at Screening, Day 1 and Day 8. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values (Day 1 and Day 8). Baseline was defined as Screening.|Baseline (Screening), Day 1 and Day 8|ITT population.|||per cubic millimeter||Standard Deviation|Mean
2740838|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 7: t1/2|The t1/2 was defined as the time measured for plasma concentration to decrease by one half. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis|Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)|PK population|||hour||Geometric Coefficient of Variation|Geometric Mean
2740839|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 7: Tmax|Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis|Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)|PK population.|||hours||Full Range|Median
2740840|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 7: AUC(0-τ)|AUC(0-τ) is the AUC to the end of dosing period. For Day 7, it is the AUC measured at the end of the dosing period at Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis.|Day 7 (Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)|PK population.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740841|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 1: Apparent Clearance (CL/F)|The Clearance factor was defined as the volume of plasma cleared of the drug GSK2248761, per unit time. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.|Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|PK population.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2740842|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 1: Time to Maximum Observed Concentration (Tmax), Terminal Half-life (t1/2), Absorption Lag Time (Tlag)|Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 1. The t1/2 was defined as the time measured for plasma concentration to decrease by one half. The tlag was defined as the time taken for the drug GSK2248761, to appear in the systemic circulation following administration. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.|Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)|PK population.|||hour||Full Range|Median
2740843|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 7: Predose Concentration (C0), Concentration at End of Dosing Interval (Cτ), Minimum Observed Concentration During One Dosing Interval (Cmin) and Cmax|The C0 was defined as the concentration of drug in plasma, before dose administration on Day 7. Cτ, was defined as the concentration of drug in the plasma at the end of dosing interval. The Cmin was defined as the minimum concentration of the drug in plasma during one dosing interval on Day 7. Cmax represents the maximum concentration of GSK2248761 in the plasma on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis.|Day 7 (Pre -dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740844|NCT00945282|Primary|GSK2248761 PK Parameters Following Dose Administration on Day 1: Maximum Observed Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24)|Cmax represents the maximum concentration of GSK2248761 in the plasma. C24 is defined as the measure of plasma drug concentration of GSK2248761, 24 hours post dose, determined on Day 1. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.Data for dose normalized Cmax and C24 was reported.|Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours)|PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2740845|NCT00945282|Primary|GSK2248761 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Plasma Concentration Time Curve 0 to Infinite (AUC[0-∞]) and Area Under the Plasma Concentration Time Curve (AUC [0-24])|AUC (0-24), measured the plasma concentration of GSK2248761 against time, from time zero (pre-dose) to 24 hrs post-dose AUC (0-24) and from time zero to extrapolated infinite time AUC (0-∞). Serial blood samples were collected on Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.|Day 1 (Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|The PK Concentration Population included all participants who received GSK22648761 and underwent plasma PK sampling during the study. Participants for whom a plasma PK sample was obtained and assayed were included in the listing of plasma GSK2248761 concentration-time data.|||hours*nanograms (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
2740846|NCT00945282|Primary|HIV-1 Rate of Decline by Treatment|The rate of decrease in the viral load of HIV-1 virus in response to individual treatment was measured. The viral load data was assumed to have a log normal prior distribution and followed linear decline with non-informative conjugate prior densities. The rate of decline (slope of the day) for each treatment was measured using a PCR from Day 1 to Day 8. The slope has been reported as mean.|Day 1 to Day 8|ITT population.|||log10 copies/mL||90% Confidence Interval|Mean
2740847|NCT00945282|Primary|Change From Baseline to Nadir in Plasma HIV-1 RNA|The quantification of plasma HIV-1 RNA, was conducted for the change from baseline to on treatment nadir (maximum change) before starting HAART or Kaletra monotherapy on Day 8. The quantification was done using a PCR. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose Day 1) to Day 8|ITT population.|||log10 copies/mL||Standard Deviation|Mean
2740848|NCT00945282|Primary|Change From Baseline Through Day 8 in Plasma HIV-1 RNA|The quantitative analysis of plasma was done to evaluate the amount of HIV-1 RNA at Day 1,2,3,4,5,6,7, 8 and End of treatment visit. The quantification was done using a Polymerase chain reactor (PCR). The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose Day 1) to Day 8|The Intent-to-treat Exposed (ITT) Population was defined as all participants who met the study criteria and were randomized into the study with documented evidence of having received at least 1 dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement and have Day 1 HIV-RNA>1500 copies/mL.|||log 10 copies per milliliter (mL)||Standard Deviation|Mean
2740849|NCT00945282|Primary|Change From Baseline in HR|Vital sign measurements for HR after sitting for 5 minutes were measured. The average mean values were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 1 (4-hour), Day 4 (Pre-dose and 4 hour), Day 7 (pre-dose and 4-hour), Day 8 and follow up (Day 14)|Safety population.|||Beats per minute||Standard Deviation|Mean
2740872|NCT00945243|Secondary|Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)|Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.|24 months|8 subjects had data at 24 months.|||percentage of subjects|||Number
2740850|NCT00945282|Primary|Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements for SBP and DBP after sitting for 5 minutes were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 1, 4, 7 , Day 8 and Follow-up (Day 14)|Safety population.|||millimeters of mercury||Standard Deviation|Mean
2740851|NCT00945282|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Triplicate 12-lead ECGs were collected at different timepoints, after participants were supine for 5 minutes, during the study using an ECG machine that automatically calculated the heart rate (HR) and measures PR, QRS, QT, and QTc intervals. The three consecutive determinations were collected 5 plus or minus 2 minutes apart and all three tracings were recorded. The participants with abnormal values categorized as abnormal clinically significant (CS) and not clinically significant (NCS) were reported.|Day 1, Day 4, Day 7, Day 8 and follow-up|Safety population.|||Participants|||Count of Participants
2740852|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3.|The data for clinical chemistry parameters Thyroxine total, thyroxine binding globulin, Total T3 the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||Nanomoles per liter||Standard Deviation|Mean
2740853|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free|The data for clinical chemistry parameters Thyroxine, free the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||Picomole per liter||Standard Deviation|Mean
2740854|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters- Uric Acid|The data for clinical chemistry parameters Uric acid, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||Micromole per liter||Standard Deviation|Mean
2740855|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters- Phosphorus|The data for clinical chemistry paramaters- phosphorous, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||millimole per liter||Standard Deviation|Mean
2740856|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate|The data for clinical chemistry parameters- sodium, potassium and carbon dioxide or bicarbonate, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||milliequivalents per liter||Standard Deviation|Mean
2740857|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase|The data for clinical chemistry paramaters- alkaline phosphatase, alanine amino transferase, aspartate amino transferase, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||International units (IU) per liter||Standard Deviation|Mean
2740858|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin.|The data for clinical chemistry parameters- Blood urea nitrogen, triglycerides, glucose, creatinine, calcium, cholesterol, total bilirubin, and direct bilirubin. The change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||milligram per deciliter||Standard Deviation|Mean
2740859|NCT00945282|Primary|Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein|The data for clinical chemistry parameters Albumin and total protein, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||gram per deciliter||Standard Deviation|Mean
2740860|NCT00945282|Primary|Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration|The data for hematology parameter Mean Corpuscle Hemoglobin concentration, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population|||percentage of red blood cells||Standard Deviation|Mean
2740861|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Hematocrit|The data for hematology parameter Hematocrit, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||percentage of red blood cells||Standard Deviation|Mean
2740862|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV)|The change from baseline data for hematology parameter MCV, was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||femtoliters||Standard Deviation|Mean
2740863|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH)|The data for hematology parameter MCH, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||picogram||Standard Deviation|Mean
2740864|NCT00945282|Primary|Change From Baseline in Hematology Parameters- Total Neutrophil|The data for hematology parameter total neutrophil count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||giga cells per liter||Standard Deviation|Mean
2740865|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Red Blood Cell Count|The data for hematology parameter red blood cell count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||million cells per microliter||Standard Deviation|Mean
2740866|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Platelet Count|The data for hematology parameter platelet count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||per cubic millimeter||Standard Deviation|Mean
2740867|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Hemoglobin|The data for hematology parameter hemoglobin from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||gram per decilitre||Standard Deviation|Mean
2740868|NCT00945282|Primary|Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count|The data for hematology parameters for Basophils, eosinophils, lymphocytes, monocytes, and white blood cell count from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise.|Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Safety population.|||thousand cells per microliter||Standard Deviation|Mean
2740869|NCT00945282|Primary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to 38 days|Safety population was defined as all participants who were randomized into the study with documented evidence of receipt of at least one dose of randomized treatment.|||Participants|||Count of Participants
2740870|NCT00945256|Primary|Mixed Muscle Fractional Synthesis Rate (FSR)|The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.|Acute ( 8 hours)|FSR was not calculated for the Elderly Sodium Nitroprusside with Amino Acid Drink arm of the study.|||Fractional Synthesis Rate (pecent/hour)||Standard Error|Mean
2740871|NCT00945243|Secondary|Implant Related Complications|Percentage of subjects who had an implant related complication|24 months|11 subjects were enrolled and treated on protocol and were thus considered for safety information|||percentage of subjects|||Number
2740874|NCT00945139|Primary|Progression Free Survival (PFS) by GCIC Criteria|Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.|Up to 25 months|28 out of 46 enrolled patients were assessable for PFS per GCIC criteria. The remaining patients could not be evaluated for this endpoint because the timing of their CA-125 measurements did not meet the defined criteria.|||Months||95% Confidence Interval|Median
2740875|NCT00945139|Secondary|Overall Response Rate (ORR) by GCIC Criteria|A response according to GCIC criteria has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment.|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||percentage of participants||95% Confidence Interval|Number
2740876|NCT00945139|Secondary|Clinical Benefit Rate (by RECIST)|Clinical Benefit Rate (CBR) is the sum of the percentages of patients achieving complete response, partial response, and stable disease. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||percentage of participants||95% Confidence Interval|Number
2740877|NCT00945139|Secondary|Overall Response Rate (ORR) by RECIST|ORR is the sum of the percentages of patients achieving complete and partial responses. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0)|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||Percentage of participants||95% Confidence Interval|Number
2740878|NCT00945139|Secondary|Overall Survival|The time from treatment initiation to death by any cause|4 years||||Months||Full Range|Median
2740879|NCT00945139|Primary|Progression Free Survival (PFS) by RECIST Criteria|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 25 months|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||Months||Full Range|Median
2740880|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with anisometropic amblyopia (no strabismus) who had measureable stereoacuity at randomization and at the 10-week primary outcome exam.|||participants|||Number
2740881|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia||10 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.|||participants|||Number
2740882|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia||Randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.|||participants|||Number
2740883|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam.|||participants|||Number
2740884|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks||10 weeks after randomization|The analysis includes all participants who completed the 10-week exam.|||participants|||Number
2740885|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization|"The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800.~We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing.~The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank."|Randomization|The analysis includes all participants who completed the 10-week exam.|||participants|||Number
2740886|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later||||logMAR lines||Standard Deviation|Mean
2740887|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2740888|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||logMAR lines||Standard Deviation|Mean
2740894|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2740895|NCT00945100|Secondary|Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR lines||Standard Deviation|Mean
2740896|NCT00945100|Secondary|Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2740897|NCT00945100|Secondary|Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR||Standard Deviation|Mean
2740898|NCT00945100|Secondary|Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2740899|NCT00945100|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||units on a scale||Standard Deviation|Mean
2740900|NCT00945100|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||logMAR||Standard Deviation|Mean
2740901|NCT00945100|Primary|Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR lines||Standard Deviation|Mean
2740902|NCT00945100|Primary|Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
2769799|NCT00737737|Primary|Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?||4 weeks||||ng/ml|||Number
2740903|NCT00945100|Primary|Mean 10-week Amblyopic Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR||Standard Deviation|Mean
2740904|NCT00945100|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
2740905|NCT00945100|Secondary|Treatment Group Comparison of 10-week Interocular Difference|The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||logMAR lines||Standard Deviation|Mean
2740906|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
2740907|NCT00945100|Secondary|Average Compliance With Prescribed Patching by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization or later||||participants|||Number
2740908|NCT00945100|Secondary|Compliance With Prescribed Patching by Treatment Group at 10 Weeks|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization||||participants|||Number
2740909|NCT00945100|Primary|Distribution of 10-week Amblyopic Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
2740910|NCT00945035|Primary|Peak Plasma Concentration (Cmax) for Etoricoxib||Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.|||ng/mL||Standard Deviation|Least Squares Mean
2740911|NCT00945035|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib|The area under the plasma concentration vs time curve.|Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.|||µg times hr/mL||Standard Deviation|Least Squares Mean
2740912|NCT00945009|Primary|Percentage of Patients Who Had Definitive Surgical Treatment|Percentage of Bilateral Wilms Tumor (BWT) patients who undergo definitive surgery by week 12 after initiation of chemotherapy.|12 weeks from study entry|Eligible and evaluable Bilateral Wilms Tumor patients. 6 patients were excluded due to ineligible and 6 patients were excluded due to protocol violation.|||percentage of participants||95% Confidence Interval|Number
2740913|NCT00945009|Primary|Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy|Percentage of patients who experienced partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.|12 weeks from study entry|Eligible and evaluable patients with unilateral high risk tumors who had partial or complete nephrectomy. 16 total patients were excluded (1 ineligible, 1 inevaluable, 1 violated protocol, and 13 did not have definitive surgery (partial or complete nephrectomy).|||percentage of patients||95% Confidence Interval|Number
2744175|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
2740914|NCT00945009|Primary|Number of Patients Without Complete Removal of at Least One Kidney|To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development.|12 weeks from the study entry|Eligible and evaluable patients with diffuse hyperplastic perilobar nephroblastomatosis (DPHLN).|||Participants|||Count of Participants
2740915|NCT00945009|Primary|Kidney Preservation After Preoperative Chemotherapy|Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT).|12 weeks from study entry|Eligible and evaluable Bilateral Wilms Tumor patients who completed pre-nephrectomy chemotherapy (VAD). 49 patients who did not complete VAD were excluded.|||Percentage of patients||95% Confidence Interval|Number
2740916|NCT00945009|Primary|Event-Free Survival (EFS)|Probability of no relapse, secondary malignancy, or death whichever occurs first|4 years from study enrollment|All eligible BWT patients. 6 patients were excluded due to ineligibility and 6 patients were excluded due to protocol violation.|||Probability||95% Confidence Interval|Mean
2740917|NCT00944749|Primary|Number of Participants With Complete Response at 3 Months.|"The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA).~A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb > 10 g/dL, and platelet count > 100×109/L.~A partial response was defined as a hematologic response that was not sufficient for a complete response.~In subjects with a non-robust hematologic response at 3 months, improvement in one or more of the listed peripheral blood parameter (a,b,c) were recorded as a response: a) ANC - if baseline ANC below 0.5×109/L, increase in ANC by > 0.3×109/L, if baseline ANC above 0.5×109/L, any increase in ANC by > 0.5×109/L of blood; (b) platelets - if baseline platelet count < 50×109/L, any increase in platelet count by > 20×109/L of blood; c) hemoglobin - any increase in hemoglobin by 1.5 g/dl of blood in transfusion-independent patients and in absolute reticulocyte count to > 60×109/L of blood in transfusion-dependent patients."|3 months||||Participants|||Count of Participants
2740918|NCT00944749|Primary|Number of Participants With Complete Response at 3 Months.|"The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA) defined as bone marrow cellularity of less than 30% and severe pancytopenia with at least two of the following peripheral blood count criteria: (i) absolute neutrophil count less than 0.5×109/L; (ii) absolute reticulocyte count less than 60×109/L; and (iii) platelet count less than 20×109/L.~A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb > 10 g/dL, and platelet count > 100×109/L.~A partial response was defined as a hematologic response that was not sufficient for a complete response."|3-months||||Participants|||Count of Participants
2740919|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia||12 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 12-week exam.|||participants|||Number
2740920|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of >800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.|12 weeks after randomization|The analysis includes all participants who completed the 12-week exam.|||participants|||Number
2740921|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit||10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)||||participants|||Number
2740922|NCT00944710|Secondary|Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR lines||Standard Deviation|Mean
2740923|NCT00944710|Secondary|Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2740924|NCT00944710|Secondary|Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR||Standard Deviation|Mean
2740925|NCT00944710|Secondary|Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
2740926|NCT00944710|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||logMAR lines||Standard Deviation|Mean
2740927|NCT00944710|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||logMAR||Standard Deviation|Mean
2740928|NCT00944710|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
2740929|NCT00944710|Secondary|Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization||||change in lines||Standard Deviation|Mean
2740930|NCT00944710|Secondary|Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization||||participants|||Number
2740931|NCT00944710|Secondary|Mean Fellow-Eye Visual Acuity at 12-week Exam||12 weeks after randomization||||logMAR||Standard Deviation|Mean
2740932|NCT00944710|Secondary|Distribution of 12-week Fellow-Eye Visual Acuity|Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.|12 weeks after randomization||||participants|||Number
2740933|NCT00944710|Secondary|Mean Interocular Difference at 12-week Exam|Mean Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization||||logMAR lines||Standard Deviation|Mean
2740934|NCT00944710|Secondary|Distribution of Interocular Difference at 12-week Exam|Distribution of Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization||||participants|||Number
2740935|NCT00944710|Primary|Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR lines||Standard Deviation|Mean
2740936|NCT00944710|Primary|Distribution of the Change in Amblyopic-Eye Visual Acuity|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
2740937|NCT00944710|Primary|Mean 10-week Amblyopic-Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR||Standard Deviation|Mean
2740938|NCT00944710|Secondary|Average Atropine Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)||||participants|||Number
2740939|NCT00944710|Secondary|Atropine Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization||||participants|||Number
2740940|NCT00944710|Secondary|Average Spectacle Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)||||participants|||Number
2740941|NCT00944710|Secondary|Spectacle Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization||||participants|||Number
2740942|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
2740943|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization|"The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||participants|||Number
2740944|NCT00944710|Primary|Distribution of 10-week Amblyopic-Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
2740945|NCT00944697|Primary|Short Form McGill Pain Score.|The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B - rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.|Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)||||units on a scale||Standard Deviation|Mean
2740946|NCT00944671|Secondary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng/mL||95% Confidence Interval|Geometric Mean
2740947|NCT00944671|Secondary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng*h/mL||95% Confidence Interval|Geometric Mean
2740948|NCT00944671|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng/mL||95% Confidence Interval|Geometric Mean
2740949|NCT00944671|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng*hr/mL||95% Confidence Interval|Geometric Mean
2740950|NCT00944658|Secondary|The Safety and Tolerability of Apremilast in AS, Number of Participants With Adverse Events|To evaluate the safety and tolerability of Apremilast in AS, the investigator recorded the incidence of adverse events.|16 weeks||||Participants|||Count of Participants
2740951|NCT00944658|Primary|Effect of Apremilast in Patients With AS, Changes in BASFI Score|Bath Ankylosing Spondylitis Functional Index (BASFI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2740952|NCT00944658|Primary|Changes of Apremilast on the Signs and Symptoms of AS, Night Pain From Baseline|"This endpoint the night time pain score change was recorded by questionnaire to evaluate the Apremilast effect on symptom, higher reduction better improvement.~scale is 0-10"|Baseline and 12 weeks||||score on a scale||Standard Deviation|Mean
2740953|NCT00944658|Primary|Changes of Apremilast in Patients With AS, Changes in BASDAI Score From Baseline|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2740954|NCT00944645|Primary|Maximum Concentration (Cmax) of Laropiprant|Measure of rate of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant Cmax and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet.|||micro Molar||Standard Deviation|Median
2740955|NCT00944645|Primary|Area Under Curve (AUC 0-infinity) of Laropiprant|Measure of extent of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant AUC0-infinity and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet|||Micro Molar times Hour||Standard Deviation|Median
2740956|NCT00944645|Primary|Total Amount of Urinary Excretion of Niacin and Its Metabolites|Measure of extent of absorption of ER niacin|Predose and up to 96 hours postdose|A linear mixed effect model was used to analyze total amount of urinary excretion of niacin and its metabolite and uses data available from at least one treatment period. 157 subjects had data from the treatment of MK0524A New Site Tablet, and 161 subjects had data from the treatment of MK0524A Phase III Tablet|||micro mole||Standard Deviation|Median
2740957|NCT00944645|Primary|Maximum Plasma Concentration (Cmax) of Nicotinuric Acid|Measure of rate of absorption of ER niacin|Predose and up to 24 hours postdose|The Hodges-Lehmann estimator was used to analyze nicotinuric acid Cmax and uses only subjects with data available on both treatment periods. 188 subjects were randomized,17 subjects discontinued, 26 subjects were inadvertently overdosed with 5 tablets of MK0524A 1000 mg/20 mg, reducing the available subject population for analysis to 145.|||ng/mL||Inter-Quartile Range|Median
2740958|NCT00944554|Primary|Days to Relapse|Number of days following the programmed lapse exposure until relapse to smoking occurred|4 weeks||||days||Standard Deviation|Mean
2740959|NCT00944528|Other Pre-specified|Magnetic Resonance Images(MRI)|Pre and post-radiotherapy for exploratory analysis of radiation response.|Pre and post SRS radiosurgery|||||||
2740960|NCT00944528|Other Pre-specified|Acquire Tissue|Pre and post-radiotherapy for exploratory analysis of radiation response|Pre and post SRS radiosurgery|||||||
2740961|NCT00944528|Secondary|Local Control||3 years|Data not collected.||||||
2740962|NCT00944528|Secondary|Cosmetic Outcome|"Percent of patients with excellent or good cosmetic outcome at 3 years based on physician's assessment.~EXCELLENT is defined as: when compared to the untreated breast or the original appearance of the treated breast, there is minimal or no difference in the size or shape of the treated breast. The way the breast feels (its texture) is the same or slightly different. There may be thickening, scar tissue, or seroma within the breast but not enough to change the appearance.~GOOD is defined as: there is mild asymmetry between the breasts, which means that there is some acceptable difference in the size or shape of the treated breast as compared to the opposite breast or the appearance of the breast before treatment. There may be some mild reddening or darkening of the breast. The thickening or scar tissue within the breast causes a mild change in its shape or size."|3 years|Participants with a physician's assessment available.|||percentage of participants|||Number
2740963|NCT00944528|Primary|Maximum Tolerated Dose|As measured by the incidence of acute toxicity and wound healing complications|30 days|Participants receiving all dose levels (8 at 15Gy/Dose level 1, 8 at 18Gy/Dose level 2, 16 at 21Gy/Dose level 3)|||Gray (Gy)|||Number
2740964|NCT00944450|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects|||μmol/L||Standard Deviation|Geometric Mean
2740965|NCT00944450|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects|||μmol*hr/L||Standard Deviation|Geometric Mean
2740966|NCT00944229|Primary|Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.||||||
2740967|NCT00944229|Primary|Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.||0 and after 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.||||||
2740968|NCT00944229|Primary|Change in Peak VO2||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.||||||
2740969|NCT00944125|Primary|Change in Left Ventricular End Systolic Volume (LVESV)|The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.|At 6 months to one year|Analysis population was based on the two randomized groups per the protocol.|||ml||Standard Deviation|Mean
2740970|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2769845|NCT00737633|Secondary|Percent Weight Change From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)|||percent change||Standard Deviation|Mean
2740971|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740972|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740973|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740974|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740975|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740976|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740977|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741004|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2740978|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740979|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740980|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 8-10 and 21 after first vaccination|All participants with blood collected at the timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740981|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740982|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740983|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.|||Participants|||Number
2740984|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740985|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination|All participants with blood collected at baseline and with at least one evaluable time point after vaccination are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2744176|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
2740986|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|All participants with blood collected at the timepoint within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740987|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740988|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740989|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|Participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.|||Participants|||Number
2740990|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740991|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2740992|NCT00944073|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2740993|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2740994|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741213|NCT00943436|Primary|Percent Energy From Protein at the Meal (Exercise Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
2740995|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2740996|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2740997|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2740998|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2740999|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2741000|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2741001|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741002|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741003|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2742341|NCT00936208|Primary|Change in Systolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24|||mmHg||Standard Deviation|Mean
2741005|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2741006|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2741007|NCT00944047|Primary|Pathologic Complete Response||22 weeks||||percentage of participants|||Number
2741008|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|day 1 to day 7 after vaccination|The analysis was done on safety population|||participants|||Number
2741009|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the Safety Population.|||participants|||Number
2741010|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA|1 month after booster vaccination|The analysis was performed on the per-protocol population|||IU/mL||95% Confidence Interval|Geometric Mean
2741011|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.|1 month after booster vaccination|The analysis was performed on the per-protocol population|||IU/mL||95% Confidence Interval|Geometric Mean
2741012|NCT00944034|Secondary|Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months|Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after second vaccination|The analysis was performed on the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2741013|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)|||Titers||95% Confidence Interval|Geometric Mean
2741014|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2741015|NCT00944034|Secondary|Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.|The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)|||Titers||95% Confidence Interval|Geometric Mean
2741214|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Rest Session)|carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
2741016|NCT00944034|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.|1 month after booster|The analysis was performed on the per-protocol population|||percentage of subjects||95% Confidence Interval|Number
2741017|NCT00944034|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.|Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.|1 month after booster|The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.|||percentage of subjects||98.3% Confidence Interval|Number
2741018|NCT00944034|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.|1 month after booster|The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.|||percentage of subjects||98.3% Confidence Interval|Number
2741019|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24 and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||hour||Standard Deviation|Mean
2741020|NCT00944021|Secondary|Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12,16, 24, and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||ng/mL||Standard Deviation|Mean
2741021|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||hours||Standard Deviation|Mean
2741022|NCT00944021|Secondary|Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||ng * hour/mL||Standard Deviation|Mean
2741023|NCT00944021|Secondary|Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||ng/mL||Standard Deviation|Mean
2741024|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.|||hours/day||Standard Deviation|Mean
2741025|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.|||hours/day||Standard Deviation|Mean
2741026|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).||Fourteen consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.|||hours/day||Standard Deviation|Mean
2741027|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10CFU/ml/day||Standard Deviation|Mean
2742342|NCT00936208|Primary|Change in Diastolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24|||mmHg||Standard Deviation|Mean
2741028|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10CFU/ml/day||Standard Deviation|Mean
2741029|NCT00944021|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).||14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10CFU/ml/day||Standard Deviation|Mean
2741030|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Intent to treat analysis|||percent change||Standard Deviation|Mean
2741031|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Per protocol - Only subjects with values at baseline and Week 48 endpoint are included.|||percent change||Standard Deviation|Mean
2741032|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Intent to treat analysis|||percent change||Standard Deviation|Mean
2741033|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.|||percent change||Standard Deviation|Mean
2741034|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 12|Day 0 to Week 12|Intent to treat analysis|||percent change||Standard Deviation|Mean
2741035|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c over first 12 weeks (Stage I)|Day 0 and Week 12|Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.|||percent change||Standard Deviation|Mean
2741036|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.|||Participants|||Number
2741037|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.|||Participants|||Number
2741038|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.|||Participants|||Number
2741039|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
2741040|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
2741041|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.|||Participants|||Number
2741042|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.|||Participants|||Number
2742819|NCT00932360|Secondary|Fatigue at Rest Difference Score Pre-intervention and Post Intervention|Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.|3 weeks||||units on a scale||Standard Error|Mean
2741043|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.|||Participants|||Number
2741044|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
2741045|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
2741046|NCT00943878|Primary|Number of Participants Reporting Fever After the Third Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
2741047|NCT00943878|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
2741048|NCT00943878|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
2741049|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination are included. Analyses are as treated.|||Participants|||Number
2741050|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
2741051|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741052|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741421|NCT00942890|Secondary|Pain Severity|"Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its worst, least, average, and current level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items."|0, 3, 6, 9, 12 wks||||units on a scale||Standard Deviation|Mean
2741053|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741054|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741055|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
2741056|NCT00943878|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741057|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741058|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741059|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741086|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2769846|NCT00737633|Primary|Change in HbA1c From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)|||percent change||Standard Deviation|Mean
2741060|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741061|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741062|NCT00943878|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2741063|NCT00943878|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741064|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741065|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo|"The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P =~pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline."|Baseline and 10 hours postdose|All subjects who received single doses of Losartan 100 mg + ISMN 60 mg and/or single dose of placebo|||Percent Change||Standard Deviation|Least Squares Mean
2741066|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg|The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.|Baseline and 10 hours postdose|All subjects who received single doses of losartan 100 mg + ISMN 60 mg and/or single dose of losartan 100 mg|||Percent Change||Standard Deviation|Least Squares Mean
2741087|NCT00943735|Secondary|Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741422|NCT00942890|Primary|Lower Extremity Mobility-Chair Rise|Mobility was measured by the number of stands during the 30-second chair rise test.|6, 12 wks||||Number of stands||Standard Deviation|Mean
2741067|NCT00943826|Secondary|Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs - SAEs). Nine participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for Safety.|Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])|Safety Population included all randomized participants who received study treatment during the treatment period (10 participants did not receive at least one dose of study treatment and were therefore excluded, 4 in Placebo and 6 in Bevacizumab.|||Participants|||Number
2741068|NCT00943826|Secondary|PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)|EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; & global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL >/=10 points for functioning/global health status, & decrease of >/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction & communication deficit (BN20). PFS: randomization to PD or death. PD: >=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.|Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)|Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category.|||Months||Full Range|Median
2741069|NCT00943826|Secondary|Kaplan-Meier (KM) Estimate of Two Year Overall Survival|KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood's formula.|Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.|||probability of being alive||95% Confidence Interval|Number
2741070|NCT00943826|Secondary|Kaplan-Meier (KM) Estimate of One Year Overall Survival|KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula.|Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.|||probability of being alive||95% Confidence Interval|Number
2741071|NCT00943826|Secondary|PFS as Assessed by an Independent Review Facility|An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as >=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.|Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])|Intent to treat population.|||Months||95% Confidence Interval|Median
2741072|NCT00943826|Primary|Co-Primary: Overall Survival (OS)|Overall Survival was defined as the time from randomization to death due to any cause.|Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.|||Months||95% Confidence Interval|Median
2741073|NCT00943826|Primary|Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator|PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization [WHO] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging [MRI] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.|Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)|Intent to treat population.|||Months||95% Confidence Interval|Median
2741074|NCT00943787|Secondary|Maximum Epinephrine Response (ADRR Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.~Average Daily Risk Range (ADRR) is associated with glycemic variability and risk of both hyper- and hypoglycemia.~Low Risk, ADRR < 20; Moderate Risk, 20 < ADRR < 40; and High Risk,ADRR > 40."|285 min (time of clamp)|3 participants did not have enough epinephrine data|||pg/ml||Standard Deviation|Mean
2741088|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741075|NCT00943787|Primary|Maximum Epinephrine Response (LBGI Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.~Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40-55% of the variance of future significant hypoglycemia in the subsequent 3-6 months. The LBGI has established risk categories: Low Risk, LBGI < 2.5; Moderate Risk, 2.5 < LBGI < 5; and High Risk, LBGI > 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category."|285 min (time of clamp)|3 participants did not have adequate epinephrine data.|||pg/ml||Standard Deviation|Mean
2741076|NCT00943761|Primary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)|SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.|72 weeks|Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive >=1 dose of study drug, lack of any post-allocation endpoint data subsequent to >=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study|||Percentage of participants||95% Confidence Interval|Number
2741077|NCT00943761|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|48 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.|||Participants|||Number
2741078|NCT00943761|Primary|Number of Participants Who Experienced a Serious Adverse Event|Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.|||Participants|||Number
2741079|NCT00943761|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.|||Participants|||Number
2741080|NCT00943735|Secondary|Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview||Enrollment (Day 0) up to 90 days|PP population; (n)=CATI response valid n at observation. Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid n, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741081|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741082|NCT00943735|Secondary|Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741083|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With Their Physician||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741084|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers|"Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741085|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741089|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors|The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741090|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Learned Something About Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741091|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)|Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741092|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741093|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741094|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741095|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741096|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741097|NCT00943735|Secondary|Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan|Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741098|NCT00943735|Secondary|Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary|"For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741127|NCT00943670|Secondary|Number of Participants With Decreased Ejection Fraction|"Left ventricular ejection fraction (LVEF) was assessed on the basis of local assessments of echocardiogram or multigated acquisition scan (MUGA) data. A decrease in LVEF is defined as a decrease from Baseline of greater than or equal to 15%.~Grade 3 LVEF is an ejection fraction between 20 and 40%."|Assessed at Baseline and after every 3 cycles, up to 1 year.|Safety-Evaluable Patients (i.e., the treated population).|||participants|||Number
2741099|NCT00943735|Secondary|Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker|"YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to wait), daily Toviaz® (always take as directed), and keep track (share with your doctor)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741100|NCT00943735|Secondary|Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741101|NCT00943735|Secondary|"Percentage of Participants Who Reported That They Trained Their Bladder to Wait"|"The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating I'm the boss - not my bladder)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741102|NCT00943735|Secondary|Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices|The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741103|NCT00943735|Secondary|Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms|The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741104|NCT00943735|Secondary|Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit|"YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for Core 4 elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and track your progress brochure; and recipes using bladder-friendly foods."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741105|NCT00943735|Secondary|Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741106|NCT00943735|Secondary|Percentage of Participants Who Visited the YourWay Website|YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants' Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
2741107|NCT00943735|Secondary|Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.|Enrollment (Day 0) up to 90 days|PP population|||percentage of participants||95% Confidence Interval|Number
2741423|NCT00942890|Primary|Lower Extremity Mobility- Stair Climb|Mobility was measured by the time to complete a timed stair climb.|6, 12 wks||||Seconds||Standard Deviation|Mean
2741108|NCT00943735|Secondary|Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.|Enrollment (Day 0) up to 90 days|PP population|||percentage of participants||95% Confidence Interval|Number
2741109|NCT00943735|Primary|Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment|Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.|Enrollment (Day 0) up to 90 days|Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.|||percentage of participants||95% Confidence Interval|Number
2741110|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||Percentage of Participants||95% Confidence Interval|Number
2741111|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||Percentage of Participants||95% Confidence Interval|Number
2741112|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||Percentage of Participants||95% Confidence Interval|Number
2741113|NCT00943722|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.|||Percentage of Participants|||Number
2741114|NCT00943722|Primary|Percentage of Participants With Systemic AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.|||Percentage of Participants|||Number
2741115|NCT00943722|Primary|Percentage of Participants With Injection Site Adverse Experiences (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.|||Percentage of Participants|||Number
2741176|NCT00943592|Primary|Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
2741424|NCT00942890|Primary|Lower Extremity Mobility- Up and Go|"Mobility was measured by the time to complete an up and go test."|6, 12 wks||||Seconds||Standard Deviation|Mean
2741425|NCT00942890|Primary|Lower Extremity Mobility-Distance|Mobility was measured by the distance walked in 2 minutes.|6, 12 wks||||inches||Standard Deviation|Mean
2741116|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
2741117|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
2741118|NCT00943722|Primary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
2741119|NCT00943683|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|During the 6 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2741120|NCT00943670|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATAs) to Trastuzumab Emtansine|The number of participants with anti-T-DM1 antibodies was assessed using a validated bridging antibody enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|Evaluable patients, defined as patients who had at least one ATA measurement available for analysis at Baseline (pre-dose in Cycle 1) and post-baseline.|||participants|||Number
2741121|NCT00943670|Secondary|Volume of Distribution at Steady State for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||mL/kg||Standard Deviation|Mean
2741122|NCT00943670|Secondary|Clearance T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||mL/day/kg||Standard Deviation|Mean
2741123|NCT00943670|Secondary|Terminal Half-life for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||days||Standard Deviation|Mean
2741124|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero extrapolated to infinity (AUCinf) for T-DM1 (conjugated trastuzumab) and total trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycle 1.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||μg * day/mL||Standard Deviation|Mean
2741125|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero to time of last measurable concentration (AUClast) for T-DM1 (conjugated trastuzumab) and Total Trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1 and Cycle 3.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||μg * day/mL||Standard Deviation|Mean
2741126|NCT00943670|Secondary|Maximum Observed Serum Concentration of T-DM1 and Total Trastuzumab|Serum samples were quantitated for T-DM1 (DM1 conjugated to trastuzumab) levels in a validated assay using an indirect sandwich enzyme-linked immunosorbent assay (ELISA). The minimum quantifiable concentration in human serum was 40 ng/mL. Serum samples were assayed for total trastuzumab (conjugated and unconjugated T-DM1) in a validated assay using an indirect sandwich ELISA method; the minimum quantifiable concentration in human serum was 40 ng/mL.|Blood samples were collected prior to dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"Pharmacokinetic (PK)-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||μg/mL||Standard Deviation|Mean
2741128|NCT00943670|Secondary|Number of Participants With Adverse Events (AEs)|"An serious AE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s), or is considered a significant medical event by the investigator (e.g., may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).~The severity of each AE was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0, or as follows: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Very severe; Grade 5 = Death related to AE."|From first dose until 30 days after last dose (up to 1 year).|Safety-Evaluable Patients (i.e., the treated population).|||participants|||Number
2741129|NCT00943670|Secondary|Percentage of Participants With Clinical Benefit During the Single-agent Trastuzumab Emtansine Treatment Period|"Participants were considered to have experienced clinical benefit if they had an objective response or maintained stable disease for at least 6 months from start of study treatment. Objective response was defined as a complete or partial response determined on two consecutive tumor assessments at least 4 weeks apart based on a modified version of RECIST.~Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started and no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2741130|NCT00943670|Secondary|Progression-free Survival During the Single-agent Trastuzumab Emtansine Treatment Period|Progression-free survival (PFS) was defined as the time from the first day of study treatment (Day 1) to first documented disease progression or death, whichever occurred first. If a patient did not experience disease progression or die, PFS was censored at the day of the last tumor assessment that a patient was known to be progression free.|From the first day of study treatment to the first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients.|||months||95% Confidence Interval|Median
2741131|NCT00943670|Secondary|Duration of Objective Response Based on Investigator Assessment During the Single-agent Trastuzumab Emtansine Treatment Period|"In patients with an objective response during the single-agent trastuzumab emtansine treatment period, duration of response was defined as the time from the first documented objective response to the time of first documented disease progression or death, whichever occurred first. Progressive disease was defined as either at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with an absolute increase of at least 5 mm, or the appearance of one or more new lesions, or the unequivocal progression of existing nontarget lesions.~If a patient did not die or experience disease progression before the end of the study, duration of response was censored at the day of the last tumor assessment when the patient was known to be progression free."|Time from the first documented objective response to the time of first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients who achieved an objective response.|||months||95% Confidence Interval|Median
2741132|NCT00943670|Secondary|Percentage of Participants With an Objective Response During the Single-agent Trastuzumab Emtansine Treatment Period|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments conducted by the investigator ≥ 4 weeks apart. Responses were assessed by physical examination and imaged-based evaluation using a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0:~CR—the disappearance of all target lesions and the disappearance of all nontarget lesions and normalization of tumor marker level and no new lesions.~PR—either the disappearance of all target lesions with persistence of one or more nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter with no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug. Patients with missing or no post-baseline response assessments were classified as non-responders.|||percentage of participants||95% Confidence Interval|Number
2741133|NCT00943670|Secondary|Percentage of Participants With New Abnormal T Waves|The incidence of abnormal T-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable. C=Cycle; D=Day.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
2741134|NCT00943670|Secondary|Percentage of Participants With New Abnormal U Waves|The incidence of abnormal U-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
2741426|NCT00942890|Primary|Lower Extremity Muscle Strength- Flexion|Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.|0, 3, 6, 9, 12 wks||||Kilograms||Standard Deviation|Mean
2741135|NCT00943670|Secondary|Percentage of Participants Within Each Baseline-adjusted QTc Interval Category|"The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTc interval was subtracted from the average QTc intervals to create a baseline-adjusted average QTc interval.~QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14."|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
2741136|NCT00943670|Secondary|Percentage of Participants Within Each Absolute QTc Interval Category|The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14.|Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
2741137|NCT00943670|Secondary|Change From Baseline in Heart Rate||Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||beats per minute||Standard Deviation|Mean
2741138|NCT00943670|Secondary|Change From Baseline in QRS Duration|The QRS interval represents the time it takes for depolarization of the ventricles and was calculated from electrocardiogram (ECG) data. Each participant had triplicate QRS intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QRS interval was subtracted from the average QRS intervals to create a baseline-adjusted average QRS interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||milliseconds||Standard Deviation|Mean
2741139|NCT00943670|Secondary|Change From Baseline in PR Interval|The PR interval is the time in seconds from the beginning of the P wave to the beginning of the QRS complex, and was calculated from electrocardiogram (ECG) data. Each participant had triplicate PR intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline PR interval was subtracted from the average PR intervals to create a baseline-adjusted average PR interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG-Evaluable population|||milliseconds||Standard Deviation|Mean
2741140|NCT00943670|Secondary|Change From Baseline in Uncorrected QT Interval|The uncorrected QT interval was calculated from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QT interval was subtracted from the average QT intervals to create a baseline-adjusted average QT interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||milliseconds||Standard Deviation|Mean
2741141|NCT00943670|Secondary|Change From Baseline in Mean Duration of the QTc Interval Using Bazett's Correction|The corrected QT interval was calculated using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTcB intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcB interval was subtracted from the average QTcB intervals to create a baseline-adjusted average QTcB interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||milliseconds||Standard Deviation|Mean
2741142|NCT00943670|Primary|Change From Baseline in Mean Duration of the QTc Interval|The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population consisted of patients who received T-DM1, had at least 1 interpretable pre−T-DM1 ECG measurement recorded on Cycle 1 Day 1, had at least 1 interpretable post−T-DM1 ECG measurement and who were not treated with medications that may have altered cardiac conduction. N indicates the ECG−evaluable population at each time point.|||milliseconds||Standard Deviation|Mean
2741143|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.|||Participants|||Number
2741144|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.|||Participants|||Number
2741145|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.|||Participants|||Number
2741146|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741147|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741148|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 and Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741149|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.|||Participants|||Number
2741150|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741177|NCT00943579|Secondary|Adverse Events Reporting|This is not a standardized measure but instead a set of questions, both closed and open ended, asked of families about their child's response to the medication. Used for determining whether treatment needed to be discontinued.|Cummulative throughout study|Data were not specifically analyzed but used instead to determine whether treatment needed to be discontinued. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2741427|NCT00942890|Primary|Lower Extremity Muscle Strength- Extension|Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.|0, 3, 6, 9, 12 wks||||Kilograms||Standard Deviation|Mean
2741151|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.|||Participants|||Number
2741152|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741153|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741154|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741155|NCT00943631|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
2741156|NCT00943631|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
2741157|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
2741158|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
2741159|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
2741201|NCT00943488|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
2741160|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.|||Participants|||Number
2741161|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 8-10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 and 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741162|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
2741163|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
2741164|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
2741165|NCT00943631|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination||||Participants|||Number
2741166|NCT00943605|Secondary|Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2741167|NCT00943605|Primary|Area of Skin Necrosis Measured With a Standard Ruler||1 and 6 weeks postoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2741168|NCT00943605|Primary|Total Serous Drainage (mL) From Time of Drain Placement to Removal.||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
2741169|NCT00943592|Secondary|Relapse Rate||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
2741170|NCT00943592|Secondary|Treatment-related Mortality (TRM)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
2741171|NCT00943592|Secondary|Progression-free Survival (PFS)|Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.|1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
2741172|NCT00943592|Primary|Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
2741173|NCT00943592|Primary|Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
2741174|NCT00943592|Primary|Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
2741175|NCT00943592|Secondary|Overall Survival (OS)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
2741178|NCT00943579|Secondary|Aberrant Behavior Checklist (ABC)|This is a 58-item informant-based, factor-analyzed scale comprised of a total scale and 5 subscales that generate raw scores. Scores based on a likert scale ranging from 0-3 where 0 is not a problem to 3 where the problem is severe. Subscales include: Irritability, Social Withdrawal, Stereotypic Behaviors, Hyperactivity and Inappropriate Speech. Total maximum score is 174. Higher subscale scores indicate more symptoms. Scores are totaled to compute subscale scores. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|all participants who completed the open label extension were analyzed.|||units on a scale||Standard Error|Mean
2741179|NCT00943579|Secondary|Connor's Preschool ADHD Questionnaire|This is a measure of behavioral symptomatology in children 2-6 years of age. The ADHD scale is one subdomain.|Weeks 8 & 16|Data was not analyzed secondary to lack of significant findings in primary outcome measure and reduced number of completed questionnaires. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2741180|NCT00943579|Secondary|Preschool Language Scale, 4th Edition (PLS-4)|Measures expressive & receptive language and total scores in ages 0 to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher raw scores indicate better language skills. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept & trend modeling that accounts for each individual's initial level of symptom severity/functioning & rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants completed the open label extension were analyzed in the study.|||units on a scale||Standard Error|Mean
2741181|NCT00943579|Secondary|Parental Global Assessment|this is a measure of parents impression of improvement.|Weeks 8 & 16|the data were not analyzed secondary to lack of findings in primary outcome measure as well as the nature of an open label study. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2741182|NCT00943579|Secondary|Children's Yale Brown Obsessive Compulsive Scale|The C-YBOCS is a scale is designed to rate the severity of obsessive and compulsive symptoms in children and adolescents, ages 6 to 17 years. It can be administered by a clinican or trained interviewer in a semi-structured fashion. In general, the ratings depend on the child's and parent's report; however, the final rating is based on the clinical judgement of the interviewer. Rate the characteristics of each item over the prior week up until, and including, the time of the interview. Scores should reflect the average of each item for the entire week, unless otherwise specified.|Weeks 8 & 16|The data was not analyzed secondary to lack of significant findings in primary outcome measures and limited data collected on this measure. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2741183|NCT00943579|Secondary|Vineland Adaptive Behavior Scale, 2nd Edition|The Vineland-2 is semi-structured interview designed to communication, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite Scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. The scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in this study. Higher subscale scores indicate more skills. Raw scores can range from 0 to 766 for the overall adaptive behavior composite. Subscales are combined to form the overall Adaptive Behavior Composite, which is essentially a weighted average of the various subscales combined.|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants who completed the open label extension were analyzed.|||units on a scale||Standard Error|Mean
2741184|NCT00943579|Primary|Clinical Global Impressions Scale|This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale (1) very much improved, (2) much improved, (3) minimally improved (4) no change, (5) minimally worse, (6) much worse and (7) very much worse. Chi-square analyses were used to assess change in CHI-I scores (by group, post-test)Mixed-effects regression models determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. The mixed-effects regression model is robust to data dependency that occurs with the repeated assessments of individuals over time & can handle missing data. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|16 weeks|The number of participants analyzed included those who completed the open label extension of this study.|||# participants much - very much improved|||Number
2741185|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit.|||Participants|||Number
2741186|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.|||Participants|||Number
2741187|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.|||Participants|||Number
2741188|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741189|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit.|||Participants|||Number
2741190|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.|||Participants|||Number
2741191|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit.|||Participants|||Number
2741192|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741467|NCT00942409|Primary|Overall Response Rate||2 Years|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure||||||
2769847|NCT00737594|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment||4 weeks|Study terminated early, data were not collected.||||||
2741193|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.|||Participants|||Number
2741194|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741195|NCT00943488|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
2741196|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit.|||Participants|||Number
2741197|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741198|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.|||Participants|||Number
2741199|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741200|NCT00943488|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
2741212|NCT00943436|Primary|Percent Energy From Protein at the Meal (Rest Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
2741202|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
2741203|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
2741204|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.|||Participants|||Number
2741205|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
2741206|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
2741207|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
2741208|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
2741209|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
2741210|NCT00943436|Primary|Percent Energy From Fat at the Meal (Rest Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
2741211|NCT00943436|Primary|Percent Energy From Fat at the Meal (Exercise Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
2741215|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Exercise Session)|Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
2741216|NCT00943436|Primary|Energy Intake at the Meal (Rest Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||kilocalories||Standard Deviation|Mean
2741217|NCT00943436|Primary|Energy Intake at the Meal (Exercise Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||kilocalories||Standard Deviation|Mean
2741218|NCT00943397|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 52 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
2741219|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
2741220|NCT00943384|Secondary|Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70).|Month 24|Per protocol|||units on a scale||Standard Deviation|Mean
2741221|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
2741222|NCT00943384|Secondary|Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69).|Month 24|Per protocol|||units on a scale||Standard Deviation|Mean
2741223|NCT00943384|Secondary|Percent Change in Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
2741224|NCT00943384|Secondary|Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Per protocol.|||units on a scale||Standard Deviation|Mean
2741348|NCT00943150|Primary|Inflammatory Cell Count|Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.|0, 3, and 6 weeks||||cells per square millimeter||Standard Deviation|Mean
2741225|NCT00943384|Secondary|Percent Change in Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Back pain was assessed in the per-protocol population. Of the 55 subjects who were evaluated at the Month 24 visit, two were missing data related to back pain.|||percent change||Standard Deviation|Mean
2741226|NCT00943384|Secondary|Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Of the 55 subjects who were evaluated at Month 24, two were missing back pain data.|||units on a scale||Standard Deviation|Mean
2741227|NCT00943384|Secondary|Percent Change in Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
2741228|NCT00943384|Secondary|Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function.|Month 24|Per protocol|||units on a scale||Standard Deviation|Mean
2741229|NCT00943384|Primary|Posterolateral Fusion Success|The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status.|Month 24|The primary endpoint was evaluated for the per-protocol population. Of the 55 patients who were evaluated at the Month 24 visit, six patients were missing complete radiographic data needed to evaluate the primary endpoint.|||participants|||Number
2741230|NCT00943319|Secondary|Disease Free Survival|Disease Free Survival measured by median survival time in days|5 years||||days||95% Confidence Interval|Median
2741231|NCT00943319|Secondary|Overall Survival|Overall Survival measured as median survival in days|5 years||||days||95% Confidence Interval|Median
2741232|NCT00943319|Primary|Maximum Tolerated Dose|Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.|5 years|The 36 patients refer to the phase I portion of the study only.|||mmol-min/L|||Number
2741233|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741234|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741235|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741236|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741237|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741238|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741535|NCT00941993|Primary|Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).||Day 0||||participants|||Number
2741239|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741240|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741241|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741242|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741243|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741244|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741245|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741246|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741247|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741248|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741249|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741250|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741251|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741252|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741253|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741254|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741255|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741256|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741257|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741258|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741259|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741260|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741261|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741262|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741263|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2777610|NCT00687674|Secondary|Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)|||||||
2741264|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741265|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741266|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741267|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741268|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741269|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741270|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741271|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741272|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741273|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741274|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741275|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741276|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2744177|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
2741277|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741278|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741279|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741280|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741281|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741282|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741283|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741284|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741285|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
2741286|NCT00943306|Primary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
2741287|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741342|NCT00943150|Secondary|Diet Volume|Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||units on a scale||Standard Deviation|Mean
2777611|NCT00687674|Secondary|Changes in Microvessel Density From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)|||||||
2741288|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741289|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741290|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. This outcome restricts to age stratum.|||Participants|||Number
2741291|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741292|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741293|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741294|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741295|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741296|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741297|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741298|NCT00943202|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through 180 days after the last vaccination|All participants receiving at least one vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
2741299|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741300|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741301|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741302|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741584|NCT00941681|Primary|AUC (Day 10)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).|||hr*ng/mL||Standard Deviation|Mean
2741303|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741304|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741305|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741306|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741307|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741308|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741309|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741310|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741343|NCT00943150|Secondary|Activity Level|Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||units on a scale||Standard Deviation|Mean
2741311|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741312|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741313|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741314|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741315|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741316|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741317|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741318|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741344|NCT00943150|Secondary|Postoperative Pain Levels|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||units on a scale||Standard Deviation|Mean
2741319|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741320|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 3 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741321|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741322|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 2 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741323|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741324|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741325|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741326|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2742820|NCT00932360|Primary|Pain With Movement Difference Score Pre-intervention and Post Intervention|Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.|3 weeks||||score on a scale||Standard Error|Mean
2741327|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741328|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741329|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741330|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741331|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741332|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741333|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741334|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741345|NCT00943150|Secondary|Narcotic Consumption|Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.|Intraoperative and postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||Fentanyl microgram units/g||Standard Deviation|Mean
2741346|NCT00943150|Secondary|Change in Hemoglobin|The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.|Intraoperative|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||g/dL||Standard Deviation|Mean
2741347|NCT00943150|Secondary|Total Drainage Output||0 to 10 days postoperatively|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||mL||Standard Deviation|Mean
2741335|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741336|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741337|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and 21 days after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741338|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
2741339|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741340|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741341|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
2741349|NCT00943150|Primary|Acute Thermal Injury Depth|"Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.~Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation."|Immediately postoperative||||micrometers||Standard Deviation|Mean
2741350|NCT00943124|Primary|Total Urinary Excretion of Niacin and Its Metabolites||96 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 216 subjects were available for both MK0524B and Simvastatin + MK0524A for analysis of urinary excretion of nicotinuric acid and metabolites|||µmol||Standard Deviation|Least Squares Mean
2741351|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Nicotinuric Acid|Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin|24 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4) and missing samples (N=1), data from a total of 215 and 216 subjects available for plasma nicotinuric acid analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL||Standard Deviation|Least Squares Mean
2741352|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Laropiprant||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively|||nmol/L||Standard Deviation|Least Squares Mean
2741353|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant|Plasma Area Under the Curve of Laropiprant|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant AUC(0 to infinity) analysis for MK0524B and Simvastatin + MK0524A, respectively|||nmol/L * hour||Standard Deviation|Least Squares Mean
2741354|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 209 and 210 subjects were available for simvastatin Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL||Standard Deviation|Least Squares Mean
2741355|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin|Plasma Area Under the Curve of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 208 and 210 subjects were available for simvastatin AUC(0-48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL * Hour||Standard Deviation|Least Squares Mean
2741356|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin Acid|Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 201 and 202 subjects were available for simvastatin acid Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL||Standard Deviation|Least Squares Mean
2741357|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid|Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 200 and 202 subjects were available for simvastatin acid AUC(0 to 48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL * Hour||Standard Deviation|Least Squares Mean
2741358|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 208|Percent change in liver volume = ([liver volume at Week 208 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 liver volume assessment.|||percent change||Standard Deviation|Mean
2741359|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (in MN) at Week 208|Percent change in spleen volume = ([spleen volume at Week 208 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 spleen volume assessment.|||percent change||Standard Deviation|Mean
2741360|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 208|Percent change in platelet counts = ([platelet count at Week 208 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 platelet assessment.|||percent change||Standard Deviation|Mean
2741361|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 208|Absolute change = hemoglobin level at Week 208 minus hemoglobin level at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 hemoglobin assessment.|||g/dL||Standard Deviation|Mean
2741362|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 208 minus Z-score at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 208 Z-score assessment for specified bone area.|||Z-score||Standard Deviation|Mean
2741363|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 208 minus T-score at baseline.|Baseline, Week 208|Number of participants analyzed = participants with both baseline and Week 208 T-score assessment.|||T-Score||Standard Deviation|Mean
2741364|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 52|Percent change in liver volume = ([liver volume at Week 52 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 liver volume assessment. Eliglustat participants switching to imiglucerase were excluded.|||percent change||Standard Error|Least Squares Mean
2741365|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (MN) at Week 52|Percent change in spleen volume = ([spleen volume at Week 52 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 spleen volume assessment. Eliglustat participants switching to imiglucerase were excluded.|||percent change||Standard Error|Least Squares Mean
2741366|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 52|Percent change in platelet counts = ([platelet count at Week 52 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 platelet assessment. Eliglustat participants switching to imiglucerase were excluded.|||percent change||Standard Error|Least Squares Mean
2741367|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 52|Absolute change = hemoglobin level at Week 52 minus hemoglobin level at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 hemoglobin assessment. Eliglustat participants switching to imiglucerase were excluded.|||g/dL||Standard Error|Least Squares Mean
2741368|NCT00943111|Secondary|Hemoglobin Level||Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline hemoglobin assessment.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2741369|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 52 minus Z-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 52 Z-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.|||Z-score||Standard Error|Least Squares Mean
2741370|NCT00943111|Secondary|Total Z-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline Z-score assessment. Here, 'n' signifies participants with baseline Z-score assessment for specified bone area.|||Z-score||Standard Deviation|Mean
2741371|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 52 minus T-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 T-score assessment. Here, 'n' signifies participants with both baseline and Week 52 T-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.|||T-score||Standard Error|Least Squares Mean
2741372|NCT00943111|Secondary|Total T-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by dual energy X-Ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score greater than [>]-1), osteopenia (score -2.5 to less than or equal to [<=] -1), and osteoporosis (score <= -2.5).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline T-score assessment. Here, 'n' signifies participants with baseline T-score assessment for specified bone area.|||T-score||Standard Deviation|Mean
2741373|NCT00943111|Primary|Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in MN). Stable hematological parameters were defined as hemoglobin level did not decrease >1.5 g/dL from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume did not increase >20% from baseline.|Week 52 up to week 208|FAS population for LTTP: included all participants who received at least 1 dose of eliglustat in the extension study period. Number of participants analyzed=participants at risk at specified time-points. Here 'n' signifies number of participants with available data for specified time-points.|||percentage of participants|||Number
2741374|NCT00943111|Primary|Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in multiples of normal [MN]). Stable hematological parameters were defined as hemoglobin level did not decrease more than (>) 1.5 gram per deciliter (g/dL) from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume (in MN) did not increase >20% from baseline.|Baseline up to Week 52|Per protocol population for PAP included participants who were at least 80% compliant with treatment during PAP, had no major protocol deviations, and did not exhibit hematological decline as a result of medically determined etiologies other than Gaucher disease.|||percentage of participants||95% Confidence Interval|Number
2742709|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|24 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab|||percentage of participants|||Number
2741375|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the ITT population: defined as all randomised patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose.|||mm||95% Confidence Interval|Least Squares Mean
2741376|NCT00943098|Secondary|PIDs||at 8 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741377|NCT00943098|Secondary|PIDs||at 7 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741378|NCT00943098|Secondary|PIDs||at 6 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741379|NCT00943098|Secondary|PIDs||at 5 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741380|NCT00943098|Secondary|PIDs||at 4 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741381|NCT00943098|Secondary|PIDs||at 3 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741382|NCT00943098|Secondary|PIDs||at 2 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741383|NCT00943098|Secondary|PIDs||at 90 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741384|NCT00943098|Secondary|PIDs||at 60 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741385|NCT00943098|Secondary|PIDs||at 45 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741386|NCT00943098|Secondary|PIDs||at 30 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741387|NCT00943098|Secondary|PIDs||at 15 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
2741388|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the PP population: all patients included in the ITT population who also met all inclusion/exclusion criteria and who did not have any major protocol violation, and with post-surgical pain assessment at the primary endpoint.|||mm||95% Confidence Interval|Least Squares Mean
2741389|NCT00943072|Secondary|Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)|The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 24||||scores on a scale||Standard Deviation|Mean
2741390|NCT00943072|Secondary|Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks||Baseline to Week 24|Full Analysis Set|||percentage of participants|||Number
2741391|NCT00943072|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and at Week 24|Full Analysis Set|||microns||Standard Deviation|Mean
2741392|NCT00943072|Secondary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at Week 24|Full Analysis Set|||letters correctly read||Standard Deviation|Mean
2741393|NCT00943072|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score|"Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.~Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning."|Baseline and at Week 24|Full Analysis Set|||percentage of participants|||Number
2741420|NCT00942890|Secondary|Pain Interference|Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items.|0, 3, 6, 9, 12 wks||||units on a scale||Standard Deviation|Mean
2741394|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4|Secondary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.|||mmHg||Standard Deviation|Mean
2741395|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4|Primary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.|||mmHg||Standard Deviation|Mean
2741396|NCT00942994|Secondary|Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.|To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.|||Percentage of Responders|||Number
2741397|NCT00942994|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks|To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.|||Percentage of Participants|||Number
2741398|NCT00942994|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.|||mmHg||Standard Deviation|Mean
2741399|NCT00942994|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.|||mmHg||Standard Deviation|Mean
2741400|NCT00942968|Other Pre-specified|Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age.|Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Severely renal-impaired population included all participants who had at least 1 dose of study drug and had severe renal impairment at the baseline or developed severe renal impairment (CrCl) < 30 milliliter per minute during the study. Here, n’ signifies those participants who were evaluable at specified time points.|||mL/min||Standard Deviation|Mean
2741401|NCT00942968|Other Pre-specified|Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741402|NCT00942968|Other Pre-specified|Number of Participants With Abnormal Physical Examinations Findings|Physical examinations included head, ears, nose, throat (ENT), neck, heart, chest, lungs, abdomen, extremities, neurological systems, skin, general appearance and others (thigh, abdomen unobtrusive scar, breast, cardio-vascular, constitutional, face, genitalia, genitourinary, gastrointestinal, hematologic, left ankle unobtrusive scar, lymph nodes, lymphatic, malaise/fatigue, mouth, musculoskeletal, musculoskeletal, peripherally inserted central catheters line site left arm, psychiatric, skeletal, urinary, weight, activity level, bladder irritation, dyspnea and eastern cooperative oncology group performance status [used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead]). Abnormality in physical examinations was based on investigator's discretion.|Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium. Here ‘n’ signifies those participants who were evaluable at specified categories.|||participants|||Number
2741417|NCT00942968|Primary|Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 2 up to Month 6|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741403|NCT00942968|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for abnormality: Hemoglobin greater than or equal to(>=)130*lower limit of normal(LLN); less than or equal to(<=)170*upper limit of normal(ULN), hematocrit >=0.39*LLN;<=0.51*ULN, red blood cell >=4.5*LLN;<=5.9*ULN, platelet>=150*LLN;<= 450*ULN, white blood cells >=4*LLN;<=11*ULN; lymphocytes>=0.09;<=0.44, neutrophils=>0.16*LLN;<=0.7*ULN, eosinophils<=0.04*ULN, basophils<=0.02*ULN, monocytes>0.08*ULN; bilirubin >=5.1*LLN;<=22.2*ULN, aspartate aminotransferase >=13*LLN;<=36*ULN, alanine aminotransferase>=11*LLN;<=54*ULN, alkaline phosphatase>=31*LLN ;<=104 *ULN, total protein>=60*LLN; <=76*ULN, albumin=>35*LLN;<=50*ULN, glucose>=3.77 ;<=6.05;blood urea nitrogen>=1.785*LLN;<=7.5*ULN, creatinine>=70.7*LLN;<=114.9*ULN, creatinine kinase>=30*LLN ;<=280*ULN, lactate dehydrogenase>=85*LLN;<=180*ULN, sodium>=137*LLN ;<=144*ULN, potassium >=3.5*LLN;<=5*ULN, chloride>=102*LLN;<=111*ULN, calcium>=2.22*LLN ;<=2.57*ULN, phosphorus=>0.81 ;<=1.45); nitrogen cholesterol>=1.78*LLN ;<=7.49*ULN.|Baseline (Day 1) up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741404|NCT00942968|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline (Day 1) up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741405|NCT00942968|Secondary|Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee|Time to first occurrence of new or recurrent VTE or CVT was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE or CVT. VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE) .DVT is a blood clot in the deep veins of the leg. If a DVT clot that breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan, contrast venography or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography.|Month 1 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.|||days||Standard Error|Mean
2741406|NCT00942968|Secondary|Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee|Time to first occurrence of new or recurrent VTE was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram.|Month 1 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.|||days||Standard Error|Mean
2741407|NCT00942968|Secondary|Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘n’ signifies those participants who were evaluable at specified time intervals.|||participants|||Number
2741408|NCT00942968|Secondary|Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (adjudicated by Central Adjudication Committee) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘n’ signifies those participants who were evaluable at specified time intervals.|||participants|||Number
2741418|NCT00942903|Secondary|Noise at Stoma Occlusion|the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME|3 weeks||||patients|||Number
2741419|NCT00942903|Primary|Patient Preference for Provox HME or Provox XtraHME|the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.|3 weeks||||Patients|||Number
2742821|NCT00932360|Primary|Pain at Rest Difference Score Pre-intervention and Post Intervention|Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.|3 weeks||||units on a scale||Standard Error|Mean
2741409|NCT00942968|Secondary|Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals.|||participants|||Number
2741410|NCT00942968|Secondary|Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee|Time to first occurrence of any bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first bleeding event (major or minor). A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding.|Month 1 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||days||Standard Error|Mean
2741411|NCT00942968|Secondary|Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee|Time to first occurrence of major bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death.|Month 1 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||days||Standard Error|Mean
2741412|NCT00942968|Secondary|Number of Participants With Fatal Bleeding Events|Fatal bleeding events refers to those bleeding events which leads to death of participant. In this outcome measure, number of participants with fatal bleeding events were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741413|NCT00942968|Secondary|Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. In this outcome measure, number of participants with any (major or minor) bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741414|NCT00942968|Secondary|Number of Participants With Investigator Identified Major Bleeding Events|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
2741415|NCT00942968|Primary|Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee|VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported.|Month 7 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2741416|NCT00942968|Primary|Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 7 up to Month 12|Safety population included all participants who received at least one 1 treatment with dalteparin sodium.|||participants|||Number
2743272|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2741428|NCT00942851|Secondary|% Blepharospasm Disability Scale (BDS) Change at 3 Months|% BDS change at 3 months. The BDS is a quality of life scale ranging from 0 (no symptoms) to 26 (maximum impact of symptoms on quality of life). The questions are specific for impairment related to blepharospasm. We compared the percentage change over three months in the active and placebo arms.|baseline to 3 months|One placebo arm participant discontinued study due to unrelated personal problems|||percentage change||Standard Deviation|Mean
2741429|NCT00942851|Secondary|Change in the JBRS at 3 Months|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time.|baseline to 3 months|One placebo arm participant dropped out due to unrelated personal problems|||points||Standard Deviation|Mean
2741430|NCT00942851|Primary|Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time. Return to baseline value represents loss of benefit from BoNT injection. The time to return to baseline JBRS is an indication of added benefit from the topical intervention.|3-7 months||||month||Standard Deviation|Mean
2741431|NCT00942825|Primary|The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.||15 June 2009 to 30 September 2012|Treated population|||days||95% Confidence Interval|Median
2741432|NCT00942786|Other Pre-specified|Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events|Evaluation of the association between preoperative NT-ProBNP and occurence of adverse cardiac events|postoperatively (index surgery) until a median follow-up of 34 months||||pg/ml||Inter-Quartile Range|Median
2741433|NCT00942786|Other Pre-specified|NT-ProBNP Preoperative|NT-ProBNP was measured 0-24 hours before induction of anesthesia|0-24 hours before induction of anesthesia|Consecutive patients undergoing emergent non-cardiac surgery|||pg/ml||Inter-Quartile Range|Median
2741434|NCT00942786|Primary|Occurence of Adverse Cardiac Events|"Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death).~Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality.~Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure."|postoperatively (index surgery) until a median follow-up of 34 months||||participants|||Number
2741435|NCT00942734|Primary|12-Week Progression-Free Survival (PFS)|Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): >20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.|12 weeks|Eight participants were not evaluable.|||Percentage of Participants|||Number
2741436|NCT00942708|Secondary|Change in Six Minute Walk Distance at 3 Months|Six minute walk distance will be measured at baseline and after 3 months of fluoxetine. Change in walk distance (mean and SD) will be reported by taking subtracting baseline values from result at 3 months.|3 months|All patients completing the 12 week study were analyzed|||meters||Standard Deviation|Mean
2741437|NCT00942708|Secondary|Change Between Baseline and Three Month in the QIDS-SR Depression Scale|The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) depression scale is a questionnaire completed by the patient. Lower scores are better. Scoring can be interpreted as 7 or less: normal, 8-12: mild depression, 13-16 moderate depression, 17-20 moderate to severe depression and >20 severe depression. Results here show the median change between baseline and 3 months, making a positive change in score indicative of improvement. Total minimum score is 0 and the maximum is 27.|Baseline - 3 months (median change)||||units on a scale||Full Range|Median
2741438|NCT00942708|Primary|Change in Pulmonary Vascular Resistance (PVR) at Three Months|PVR will be measured by right heart catheterization at baseline and 3 months. Change in PVR will be determined by baseline value minus 3 month value.|Change in PVR at 3 mos (Baseline - 3 months)||||Wood units||Standard Deviation|Mean
2741439|NCT00942604|Secondary|Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions|Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area|57 days|Intention to treat population|||participants|||Number
2741440|NCT00942604|Primary|Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions|Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area|57 days|Intention to treat population|||participants|||Number
2741441|NCT00942578|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered the Four-Drug Combination|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 93 months and 22 days.||||Participants|||Count of Participants
2741442|NCT00942578|Secondary|Count of Participants With Prostatic Antigen-Specific (PSA) Declines|PSA decline is defined as a ≥50% decline in measurable disease. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm by chest x-ray, as ≥10 mm with computed tomography, or ≥10 mm with calipers by clinical exam.|median time of potential follow‐up of 47.5 months||||Participants|||Count of Participants
2741443|NCT00942578|Secondary|Count of Participants With a Radiologic Response|Radiologic response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 criteria. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|median time of potential follow‐up of 47.5 months||||Participants|||Count of Participants
2741444|NCT00942578|Secondary|Survival Based on Expression of T Cell Immunoglobulin and Mucin Domain (TIM-3) on Cluster of Differentiation 8 (CD8) + T Cells|Expression of TIM-3 on CD8 + T cells was evaluated by flow cytometry.|46.5 months||||Months||95% Confidence Interval|Median
2741445|NCT00942578|Secondary|Survival Based on Expression of Programmed Cell Death Protein 1 (PD-1) on Cluster of Differentiation 8 (CD8) + T Cells|Expression of PD-1 on CD8 + T cells was evaluated by flow cytometry. High and low expression are based on the median values. Patients with a low expression of PD-1 proteins had better survival than those with a high expression.|median time of potential follow‐up of 47.5 months||||Months||95% Confidence Interval|Median
2741446|NCT00942578|Secondary|Changes in the Molecular Markers of Angiogenesis (i.e Serum VEGF) Before and After Administration of Docetaxel, Prednisone,Lenalidomide and Bevacizumab|Serum and urine samples were collected before and after administration of Docetaxel, Prednisone, Lenalidomide and Bevacizumab to measure VEGF levels.|median time of potential follow‐up of 47.5 months|This outcome measure was not done because the blood samples collected were insufficient for measuring plasma VEGF.||||||
2741447|NCT00942578|Secondary|Count of Participants With Changes in Circulating Apoptotic Endothelial Cells (CAEC) From Baseline After Drug Administration|The definition of an increase is any increase (any number greater than zero) in the percent CAEC among total peripheral blood mononuclear cells comparing each patient's percent CAEC among total peripheral blood mononuclear cells at baseline to each patient's percent CAEC among total peripheral blood mononuclear cells at cycle 3 day 1. The definition of a decrease is any decrease (any number less than zero) in the percent CAEC among total peripheral blood mononuclear cells comparing each patient's percent CAEC among total peripheral blood mononuclear cells at baseline to each patient's percent CAEC among total peripheral blood mononuclear cells at cycle 3 day 1.|After drug administration, an average of 3 months|Data in this outcome measure is not shown per dose level because the investigator decided to pool the data for analysis since no significant difference was seen at each dose level. Outcome evaluations for cohorts of 3 and 14 patients would carry little scientific value because they are too small.|||Participants|||Count of Participants
2741448|NCT00942578|Secondary|Median Overall Survival of Patients Studied|OS is evaluated from the on-study date until the date of death or last follow-up.|median time of potential follow‐up of 47.5 months|Data in this outcome measure is not shown per dose level because the investigator decided to pool the data for analysis since no significant difference was seen at each dose level. Outcome evaluations for cohorts of 3 and 14 patients would carry little scientific value because they are too small.|||Months||95% Confidence Interval|Median
2741449|NCT00942578|Primary|Median Time to Progression (TTP)|TTP is evaluated from the on-study date until the date of progression or last follow-up after progression.|median time of potential follow-up of 47.5 months|Data in this outcome measure is not shown per dose level because the investigator decided to pool the data for analysis since no significant difference was seen at each dose level. Outcome evaluations for cohorts of 3 and 14 patients would carry little scientific value because they are too small.|||Months||95% Confidence Interval|Median
2741450|NCT00942578|Primary|Count of Participants With Dose-Limiting Toxicities (DLT)|DLT is defined as a ≥grade 3 non-hematological toxicity related to lenalidomide.|First 28 days of treatment.|Data in this outcome measure is not shown per dose level because the investigator decided to pool the data for analysis since no significant difference was seen at each dose level. Outcome evaluations for cohorts of 3 and 14 patients would carry little scientific value because they are too small.|||Participants|||Count of Participants
2741451|NCT00942578|Primary|Recommended Phase 2 Dose (RP2D)|The RP2D is the dose at which there are no dose-limiting toxicities (defined as a ≥grade 3 hematological toxicity related to lenalidomide).|3 weeks|Data in this outcome measure is not shown per dose level because the investigator decided to pool the data for analysis since no significant difference was seen at each dose level. Outcome evaluations for cohorts of 3 and 14 patients would carry little scientific value because they are too small.|||mg|||Number
2741452|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||95% Confidence Interval|Least Squares Mean
2741453|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 8 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741585|NCT00941681|Primary|T Max (Day 10)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).|||hr||Standard Deviation|Mean
2741454|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 7 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741455|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 6 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741456|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 5 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741457|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 4 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741458|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 3 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741459|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 2 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741460|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 90 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741461|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 60 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741462|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 45 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741463|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 30 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741464|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 15 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
2741465|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||95% Confidence Interval|Least Squares Mean
2741466|NCT00942422|Primary|Sustained M-protein Reduction of ≥ 25% From Baseline|"This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a minor response, an improvement recognized as having some clinical benefit."|Day one of each 28-day cycle for a total of up to 6 cycles||||percentage of patients|||Number
2741468|NCT00942357|Secondary|Patient-reported Quality of Life (QOL)|Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.|Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment|Patients who provided baseline and >= 1 follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
2741469|NCT00942357|Secondary|Patient-reported Peripheral Neuropathy Symptoms|Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms.|Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment|Patients who provided baseline and >= 1 follow-up assessment(s)|||unit on a scale||Standard Error|Least Squares Mean
2741470|NCT00942357|Secondary|Overall Survival|Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.|From entry into the study to death or the date of last contact, assessed up to 8 years|||||||
2741471|NCT00942357|Secondary|Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0|The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.|Assessed every 6 months for 3 years|All eligible and treated patients|||Participants|||Count of Participants
2741472|NCT00942357|Secondary|Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0|The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.|Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment|Eligible and treated participants|||Participants|||Count of Participants
2741473|NCT00942357|Primary|Number of Participants With Recurrence, Progression or Death|Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.|Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.|Number of recurrence, progression or death events in eligible and enrolled patients|||participants|||Number
2741474|NCT00942331|Secondary|Number of Patients Experiencing Grade 3+ Toxicity|The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.|Up to 7 years|Patients who started treatment are evaluable for adverse events.|||Participants|||Count of Participants
2741475|NCT00942331|Secondary|Objective Response Rate|Objective response rate will be defined as confirmed complete and partial responses using Response Evaluation Criteria in Solid Tumors criteria. The Cochran-Mantel-Haenszel test will be used to compare the two arms on the proportion of patients who experience an objective response adjusting on the stratification factors (presence of visceral disease [no, yes] and prior chemotherapy [no, yes]).|Up to 7 years||2020-04-30|04/2020||||
2741476|NCT00942331|Secondary|Progression-free Survival (PFS)|The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1−2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm.|From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years||2021-10-31|10/2021||||
2741477|NCT00942331|Primary|Overall Survival (OS)|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS.|From date of randomization to date of death due to any cause, assessed up to 7 years|Intent to treat (ITT) analysis population|||months||95% Confidence Interval|Median
2741478|NCT00942266|Secondary|Fluorouracil Steady-state Pharmacokinetics|Blood samples will be collected for determination of plasma 5-FU steady state concentration at 6 hours after start of 5-FU continuous infusion. The mean per treatment arm are presented.|Day 1|All treated and eligible patients|||ng/ml||95% Confidence Interval|Mean
2741479|NCT00942266|Secondary|Vorinostat Pharmacokinetics|Blood samples (5 ml of blood each) will be collected in red-top vacutainers (no anticoagulant) at 0 (pre- vorinostat), 0.5, 1, 2, 3, 4, 6, and 8 hours after the vorinostat dose on the first day of 5-FU infusion on cycle 1 (day 2 of cycle 1). Mean area under the curve is presented with 95% CI.|day 2 (cycle 1)|Vorinostat PKs were be performed on day 2 of vorinostat in the first 10 patients of each arm treated at RPCI|||hr∙μM||95% Confidence Interval|Mean
2741480|NCT00942266|Secondary|Overall Survival||Every 12 weeks|All treated and eligible patients; per protocol|||months||95% Confidence Interval|Median
2741481|NCT00942266|Secondary|Toxicity|"Number of participants with an adverse event.~Please refer to the adverse event reporting for more detail."|Daily|All treated and eligible patients; per protocol|||participants|||Number
2741482|NCT00942266|Secondary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Every 8 weeks; up to 100 weeks.|All treated and eligible patients; per protocol|||percentage of participants||95% Confidence Interval|Number
2741483|NCT00942266|Secondary|Median Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks, up to 100 weeks.|All treated and eligible patients; per protocol|||months||95% Confidence Interval|Median
2741484|NCT00942266|Primary|Disease Control Rate (Stable Disease or Objective Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|At 2 months|All treated and eligible patients; per protocol|||percentage of participants||95% Confidence Interval|Number
2741485|NCT00942188|Secondary|Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)|Pharmacokinetics Measured by Serum Concentration at End of Dosing.|Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose|All participants who received at least one dose of study drug and had evaluable PK data. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2741486|NCT00942188|Secondary|PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)|Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.|Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2741487|NCT00942188|Secondary|Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)|"The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model.~Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug."|Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose|Full Analysis Set: All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2741488|NCT00942188|Secondary|Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12|The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.|Baseline, week 10, week 12|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2741489|NCT00942188|Secondary|Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks|The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.|Baseline, 12 weeks|Full analysis set. All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).|||participants|||Number
2741490|NCT00942188|Secondary|Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks|Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.|Baseline, 12 weeks|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||microinternational Units per liter||Standard Error|Least Squares Mean
2741491|NCT00942188|Secondary|Change From Baseline in Fasting Glucose at 12 Weeks|Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.|Baseline, 12 weeks|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2741492|NCT00942188|Primary|Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.|Baseline, 12 weeks|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2741493|NCT00942175|Primary|Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.|MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK and PD statistical analyses for those parameters.|||percentage of MPA||Standard Deviation|Mean
2741494|NCT00942175|Primary|Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.|Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.|||percentage of MPA||Standard Deviation|Mean
2741495|NCT00942175|Primary|Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).|PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.|||percent inhibition||Standard Deviation|Mean
2741496|NCT00942175|Primary|Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.|Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 9 of each period|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.|||ng*hr/ML||Standard Deviation|Mean
2741497|NCT00942175|Primary|Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 9 of each period|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.|||ng/mL||Standard Deviation|Mean
2741498|NCT00942162|Secondary|Number of Patients Reported With Unsolicited AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Through 30 days after the last administration of the study treatment, up to 49 months|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741499|NCT00942162|Secondary|Number of Patients Reported With Unsolicited Adverse Events (AEs) by Maximum Grade.|The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Through 30 days after the last administration of the study treatment, up to 49 months|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741500|NCT00942162|Secondary|Number of Patients With Autoimmune Diseases or Immune-mediated Inflammatory Disorders|Auto-immune diseases or immune-mediated inflammatory disorders were tabulated during the whole duration of the study (up to 30 days after the last administration of the study treatment). The results were tabulated as Any event(s) reported.|Month 0 - Month 49|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741501|NCT00942162|Secondary|Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade|The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G4, and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741502|NCT00942162|Secondary|Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade|The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2770128|NCT00736099|Secondary|Number of Patients With HbA1c<6.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||participants|||Number
2741503|NCT00942162|Secondary|Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade|The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741504|NCT00942162|Secondary|Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade|The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G4, and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741505|NCT00942162|Secondary|Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade|The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741506|NCT00942162|Secondary|Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade|The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741507|NCT00942162|Secondary|Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade|The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741508|NCT00942162|Secondary|Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade|The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741509|NCT00942162|Secondary|Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade|The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741510|NCT00942162|Secondary|Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade|The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).|Month 0 - Month 49 (each patient was censored out of the analysis at time of death)|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment and was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741511|NCT00942162|Secondary|Anti-PD Antibody Response|Anti-PD antibody response defined as: For initially seronegative patients: post-vaccination antibody concentration ≥ 100 EU/mL; For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.|PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)|The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.|||Participants|||Count of Participants
2741512|NCT00942162|Secondary|Anti-MAGE-A3 Antibody Response|Anti-MAGE-A3 antibody response defined as: For initially seronegative patients: post-vaccination antibody concentration ≥ 27 EU/mL; For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.|PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)|The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.|||Participants|||Count of Participants
2741513|NCT00942162|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in ELISA units per milliliter (EL.U/mL).|PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)|The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2741514|NCT00942162|Secondary|Number of Seroconverted Patients for Protein D|Seroconversion was defined as a concentration of antibodies assessed that was ≥ the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-PD antibody concentrations ≥ 100 EL.U/mL|PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)|The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.|||Participants|||Count of Participants
2741515|NCT00942162|Secondary|Anti-MAGE-A3 Antibody Concentrations|Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)|The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2741516|NCT00942162|Secondary|Number of Seroconverted Patients for Anti-MAGE-A3|Seroconversion was defined as a concentration of antibodies assessed that was greater than or equal to (≥) the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27.|PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49).|The analysis was performed on the According-To-Protocol Population (ATP) for immunogenicity, which included all evaluable patients for whom immunogenicity data were available.|||Participants|||Count of Participants
2741517|NCT00942162|Secondary|Duration of Stable Disease (SD), or Time-to-Progression (TTP) by GS|The duration of stable disease (SD), or TTP, was tabulated for patients whose best response was SD. The minimal time interval required between 2 measurements for determination of SD was 12 weeks.|Month 0 - Month 24|The analysis was performed on the Stable Disease Population, which included the patients whose best response was stable disease. To qualify as SD for the best overall response, the patient should be in a SD status for a minimum of 12 weeks, as documented by two consecutive visits 12 weeks apart, or a SD status 12 weeks after baseline evaluation.|||Months||95% Confidence Interval|Median
2741518|NCT00942162|Secondary|Duration of Response (CR or PR)|Duration of response was measured from the time when the measurement criteria for CR/ PR (whichever was recorded first) were met until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Note: As there was only one patient analysed in the MAGE-A3 GS- Group, the median duration of response was not calculated for this latter group.|Month 0 - Month 24|The analysis was performed on the Responders Population, including patients with an objective response [complete (CR) or partial response (PR)] as best overall clinical response as confirmed by repeated assessments performed at least 4 weeks apart at the time of analysis. The analysis was assessed in the overall population regardless of GS status.|||Months||95% Confidence Interval|Median
2741519|NCT00942162|Secondary|Best Overall Response (BOR) by GS|The BOR was the best response recorded from the start of the treatment until disease progression/ recurrence, except for confirmed objective response, which was reported as BOR independently of its time of occurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions without any new lesions and/or progression of existing non-target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD) without any new lesions and/or progression of existing non-target lesions; PD, >=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; NE = Non-evaluable response.|Month 0 - Month 24|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment.|||Participants|||Count of Participants
2741520|NCT00942162|Secondary|Time to Treatment Failure (TTF) by GS|The TTF was defined as the time from registration of the patient until the date of the last treatment administration, irrespective of the reason for study treatment discontinuation.|Month 0 - Month 24|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. TTF was not assessed in the MAGE-A3 Unknown GS Group.|||Months||95% Confidence Interval|Median
2741586|NCT00941681|Primary|C Max (Day 10)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).|||ng/mL||Standard Deviation|Mean
2741521|NCT00942162|Secondary|Overall Survival (OS) by GS|OS was defined as the time from registration of the patient until death, with patients alive at the time of analysis censored at the time of the last contact.|Up to 5 years from the time of registration.|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. OS was not assessed in the MAGE-A3 Unknown GS Group.|||Months||95% Confidence Interval|Median
2741522|NCT00942162|Secondary|Progression-free Survival (PFS) Rate|PFS was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death, whichever comes first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. The PFS rate was estimated by the Kaplan-Meier method. The rate estimated the percentage of patients who did not progress and were alive at a given time.|Month 6, Month 12, Month 24|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. PFS was not assessed in the MAGE-A3 Unknown GS Group.|||Percentage of participants||95% Confidence Interval|Number
2741523|NCT00942162|Secondary|Progression-free Survival (PFS) by GS|From study start (Month 0) to Month 24, each patient was censored out of the analysis at 1st report of disease progression or death. PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination.|Month 0 - Month 24|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. PFS was not assessed in the MAGE-A3 Unknown GS Group.|||Months||95% Confidence Interval|Median
2741524|NCT00942162|Secondary|Number of Patients With Diseases Characteristics by GS|"Cancer staging (characteristics and categories) as by the categorization by the American Joint Committee on Cancer (AJCC) Staging Manual 2002: Stage IIIA patients have up to three microscopic nodal metastases arising from a non-ulcerating primary melanoma and have an ' intermediate risk' for distant metastases and melanom-specific survival. Stage IIIB patients have up to three microscopic nodal metastases arising from a non-ulcerating melanoma or have up to three microscopic nodal metastases arising from an ulcerating melanoma, or have intralymphatic metastases without nodal metastases. They constitute a 'high-risk' group prognostically. The remaining patients with regional melanoma are Stage IIIC patients are at 'very high risk' for distant metastases and melanoma-specific mortality. Stage IV melanoma patients have metastasis at any distant site and constitute the group with the worst prognosis. Stage MC patients are those with confirmed missing cancer."|Month 0 - Month 49|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment.|||Participants|||Count of Participants
2741525|NCT00942162|Primary|Number of Patients Reported With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.|Month 0 - Month 49|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment. Safety was assessed in the overall population regardless of GS status.|||Participants|||Count of Participants
2741526|NCT00942162|Primary|One-year Overall Survival Rate (OSR) Estimated by Complete Case Method|The 1-year overall survival rate (OSR) in the GS+ Population would be above 50% (target = 71%), a percentage which was reported together with its 95% confidence interval (CI). Maximum 1-year OSR of any currently available treatment in the MAGE-A3-positive population = 50% (P0). This median OS of 12 months is based on the observed median OS for MAGE-A3-positive patients, whose tumor did not present the predictive GS. The target 1-year OSR for patients presenting the predictive GS = 71% (P1). This corresponds to a median OS of 24 months when assuming an exponential distribution of OS.|Month 0 - Month 12|The analysis was performed on the Total Treated Population (TTP), which included all patients who received at least one dose of study treatment, but did not include patients who dropped out from the study (i.e. patients alive at the last evaluation visit and followed for less than 1 year at first database freeze).|||Percentage of Participants|||Number
2741527|NCT00942149|Secondary|Adverse Events Will be Monitored.||7 days following last dose of study drug|||||||
2741528|NCT00942149|Primary|PK of Daptomycin|Area under the curve|24 hours|all 20 subjects were analyzed|||mg*h/L||Full Range|Median
2741529|NCT00942084|Primary|Minimum Steady State Concentration (Cminss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||mg/L||Full Range|Median
2741530|NCT00942084|Primary|Steady State Concentration at 50% of the Dosing Interval (C50ss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||mg/L||Full Range|Median
2741531|NCT00942084|Primary|Maximum Steady State Concentration (Cmaxss)||up to 3 dasy of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||mg/L||Full Range|Median
2741532|NCT00942084|Primary|Half-life (T1/2)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||h||Full Range|Median
2741533|NCT00942084|Primary|Volume of Distribution (V)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||L/kg||Full Range|Median
2741534|NCT00942084|Primary|Clearance (CL)|"Timeframe:~Version 1:0-5 min,2-4 hrs,6-8 hrs post doses 1 and 5-15; prior to doses 5-15 Version 2:0-15 min post doses 1 and 5-15; within 30 min prior to doses 2 and 5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose"|V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||L/h/kg||Full Range|Median
2741536|NCT00941993|Other Pre-specified|Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.|"The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.~Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears."|Day 0|Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted|||units on a scale||Standard Deviation|Mean
2741537|NCT00941993|Secondary|Subject/Parent Reported Satisfaction With the In-office Procedure|"Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported.~The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period."|Day 0||||% adult subjects or parents||95% Confidence Interval|Number
2741538|NCT00941993|Secondary|Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale|"Includes all subjects for whom Iontophoresis current delivery was initiated.~The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.~The Wong-Baker scores are reported by subject."|Day 0|Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.|||units on a scale||Standard Deviation|Mean
2741539|NCT00941993|Primary|Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment|Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.|Day 0||||percentage of subjects||95% Confidence Interval|Number
2741540|NCT00941928|Secondary|Overall Survival (OS)|Number of surviving participants without disease progression or death for any reason at one year post treatment.|Minimum of 1 year, or until disease progression or death|||||||
2741541|NCT00941928|Primary|Time to Progression (TTP)|TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year|1 Year|Both participants had recurrent disease before single month assessment therefore no data was analyzed. Study was terminated early due to slow accrual.||||||
2741542|NCT00941889|Primary|The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.|Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.|Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment|Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.|||participants|||Number
2741543|NCT00941863|Other Pre-specified|Other Adverse Events|Frequency Threshold for reporting Other Adverse Events: 5%. The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.|||Participants|||Number
2741544|NCT00941863|Other Pre-specified|Serious Adverse Events|The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.|||Participants|||Number
2741545|NCT00941863|Secondary|Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|At day 2 in study|subjects with valid PK profiles|||hours||Full Range|Median
2741546|NCT00941863|Secondary|Maximum Concentration (CMAX) Start From Day 2 of Cycle 1|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|At day 2 in study|subjects with valid PK profiles|||mg/L||Standard Deviation|Geometric Mean
2741547|NCT00941863|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|At day 2 in study|subjects with valid pharmacokinetics (PK) profiles|||mg*h/L||Standard Deviation|Geometric Mean
2741548|NCT00941863|Secondary|Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From start of treatment until progression or death occurs assessed every 6 weeks.|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population|||Participants|||Number
2741549|NCT00941863|Primary|Participants With Hematological and Biochemical Toxicities|Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity >= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.|Start of treatment until death or within 14 days last study drug intake|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population.|||Participants|||Number
2741550|NCT00941863|Primary|Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin|MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.|21 days|All subjects who received at least 1 dose of any study drug treatment were included in the Intent-To-Treat/safety populations. Efficacy parameters of time to death, time to progression, and response rate (confirmed partial response [PR] plus complete response [CR]) were determined for this population.|||mg|||Number
2741551|NCT00941798|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit|"The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control.~Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2741552|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime|24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||percentage of days||Standard Error|Least Squares Mean
2741553|NCT00941798|Secondary|Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime|"Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment.~Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2741554|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime|Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||percentage of days||Standard Error|Least Squares Mean
2741555|NCT00941798|Secondary|Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period|"PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits.~Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis.|||liters per second||Standard Error|Least Squares Mean
2741556|NCT00941798|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||liter||Standard Error|Least Squares Mean
2741587|NCT00941681|Primary|AUC (Day 1, Dose 1)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).|||hr*ng/mL||Standard Deviation|Mean
2743273|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2741557|NCT00941798|Secondary|Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||liters||Standard Error|Least Squares Mean
2741558|NCT00941798|Secondary|Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||liters||Standard Error|Least Squares Mean
2741559|NCT00941798|Secondary|Number of Patients With at Least One Asthma Worsening Post-baseline|The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||participants|||Number
2741560|NCT00941798|Secondary|Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids|Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||participants|||Number
2741561|NCT00941798|Secondary|Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.|The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||participants|||Number
2741562|NCT00941798|Primary|Time to First Serious Asthma Exacerbation|Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||months||Full Range|Median
2741563|NCT00941733|Secondary|Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)|Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)|12 months|Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.|||percentage of participants analyzed|||Number
2741564|NCT00941733|Secondary|Days of Hospitalization|Days of hospitalization at 1 year|12 months|All randomized subjects with available data|||days||Standard Deviation|Mean
2741565|NCT00941733|Secondary|Procedural Success|Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications|Day 1|All randomized subjects with available data|||percentage of participants analyzed|||Number
2741566|NCT00941733|Secondary|Technical Success|Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography|Day 1|Number of device deployments|||percentage of device deployments|||Number
2741567|NCT00941733|Secondary|Device Success|Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities|Day 1|Number of device deployments|||percentage of device deployments|||Number
2741568|NCT00941733|Secondary|MAE (Major Adverse Events)|Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
2741569|NCT00941733|Secondary|Walking Capacity Assessment|"Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.~A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum)."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year|||units on a scale||Standard Deviation|Mean
2741570|NCT00941733|Secondary|Quality of Life Assessment by EQ5D|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.~EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for EQ5D at baseline and 1 year|||units on a scale||Standard Deviation|Mean
2741571|NCT00941733|Secondary|Secondary Sustained Clinical Improvement|Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects|||percentage of participants analyzed|||Number
2741572|NCT00941733|Secondary|Primary Sustained Clinical Improvement|Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects|||percentage of participants analyzed|||Number
2741573|NCT00941733|Secondary|Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)|Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
2741574|NCT00941733|Secondary|Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)|Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
2741575|NCT00941733|Secondary|Amputation Free Survival and Wound Healing|Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.|12 months|Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
2741576|NCT00941733|Secondary|Rate of Wound Healing|Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.|12 months|Patients with pre-existing wounds and/or occurence of new wounds|||percentage of patients analyzed|||Number
2741577|NCT00941733|Secondary|Amputation Free Survival|Percentage of participants with a 1 year amputation free survival.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
2741578|NCT00941733|Primary|Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)|Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)|6 months|Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
2741579|NCT00941733|Primary|Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients|Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).|12 months|Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.|||percentage of participants analyzed|||Number
2741580|NCT00941733|Primary|Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)|The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up|12 months or at Target Lesion Revascularization (TLR) time|ITT|||mm||Standard Deviation|Mean
2741581|NCT00941720|Secondary|Pulmonary Toxicity|Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.|At 6 months||||percentage of participants||95% Confidence Interval|Number
2741582|NCT00941720|Primary|Overall Survival|Number of patients alive at the end of the study period|at 6 months||||participants|||Number
2741583|NCT00941720|Primary|Relapse-free Survival|Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .|at 6 months||||participants|||Number
2741588|NCT00941681|Primary|T Max (Day 1, Dose 1)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).|||hr||Standard Deviation|Mean
2741589|NCT00941681|Secondary|Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure.||1 week|||||||
2741590|NCT00941681|Primary|C Max (Day 1, Dose 1)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).|||ng/mL||Standard Deviation|Mean
2741591|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)|4 weeks||||Micrograms||Standard Deviation|Mean
2741592|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)|4 weeks||||Micrograms||Standard Deviation|Mean
2741593|NCT00941655|Secondary|Patterns of Disease Recurrence Between the Two Therapeutic Approaches and Their Clinical Implications|Compare surgery + heated intraperitoneal chemotherapy + systemic chemotherapy; and systemic chemotherapy alone to determine how each group responds clinically.|up to 3 years|Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.||||||
2741594|NCT00941655|Secondary|Quality of Life (QOL) Parameters Between the Two Study Groups|QOL tools Functional Assessment of Cancer Therapy - Gastric cancer (FACT-Ga) specifically developed for the assessment of QOL in gastric cancer patients.|up to 3 years|Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.||||||
2741595|NCT00941655|Secondary|Median Duration of Cytoreduction Surgery and Heated Intraperitoneal Chemotherapy (HIPEC)|Time it takes to perform this complex surgery and HIPEC to reduce tumor burden overall in this disease.|up to 12 hours||||hours||Full Range|Median
2741596|NCT00941655|Secondary|Median Hospital Stay After Initial Surgery|Recuperation period following complex surgery for this disease.|1-10 weeks||||Days||Full Range|Median
2741597|NCT00941655|Secondary|Median Blood Loss During Surgery|Blood loss during surgery is related to complexity of the operation and via that to the stage of disease (more tumor to be cytoreduced, more blood loss).|Day 1||||ml||Full Range|Median
2741598|NCT00941655|Secondary|Completeness of Cytoreduction (CCR) Score|CCR is assessed by Sugarbaker's criteria. CCR-0 is no residual tumor. CCR-1 is no residual nodules greater than 2.5 mm in diameter, CCR-2 is no residual nodules greater than 25 mm, and CCR-3 is residual nodules greater than 25 mm.|Day 1||||Scores on a scale|||Number
2741599|NCT00941655|Secondary|Gillys Stage Before and After Surgery|Gillys stage measures the completeness of the cytoreduction and is recorded before and after surgery. It is used to classify disease burden and determine prognosis. Stage 0 is no macroscopic signs of disease, stage 1 is nodules >5mm in one part of the abdomen, stage 2 is nodules >5 mm throughout the abdomen, stage 3 is nodules 5mm to 2 cm, and stage 4 is nodules < 2 cm.|Day 1||||Stage|||Number
2741600|NCT00941655|Secondary|12 Months Disease Free Survival (DFS)|Participants who were alive and disease free at 12 months. DFS was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was disappearance of all target lesions. Partial response was at least a 30% decrease in target lesions. Progression was at least a 20% increase in target lesions and stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|12 months||||Participants|||Count of Participants
2741601|NCT00941655|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately, 40.5 months||||Participants|||Count of Participants
2741602|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II|Time between the first day of treatment and the date of death|12 weeks up to 3 years|Patient #3 - alive 17 months at time of study closure; patient 5 alive 6 months at time of study closure; patient 13 alive 8 months at time of study closure; patients 10,12 randomized but withdrew/no treatment; patient 14 randomized but did not return for treatment and lost to follow up. Patient #16 was lost to follow up after being randomized.|||Months|||Number
2741603|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I|Time between the first day of treatment and the date of death.|12 weeks up to 3 years|Patient #7 - alive 14 months at time of study closure; patient 11 alive 12 months at time of study closure; patient 15 expired following surgery.|||Months|||Number
2741604|NCT00941603|Secondary|Change From Baseline in Direct Non-HDL-C at Week 8|The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.|||Percent change||Standard Error|Least Squares Mean
2741605|NCT00941603|Primary|Change From Baseline in Direct LDL-C at Week 8|The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.|||Percent change||Standard Error|Least Squares Mean
2741606|NCT00941330|Secondary|Response Rate by Imaging|"Arm A and recurrence score ≤10: Patients will have radiologic assessment of response to exemestane by clinical examination every 4 weeks and by radiologic assessment every 2 months. Once maximal response has been achieved (stable disease for 2 months after at least 4 months of treatment by radiologic assessment) or when 12 months of therapy has been given patients will proceed to surgery.~Arm B: Patients will be assessed for surgery after 6 cycles of docetaxel and cytoxan (TC) (18 weeks).~On arm A and recurrence score ≤10 patients will be reassessed for surgery once maximal radiologic response is achieved.~On arm B, patients will be reassessed for surgery after 6 cycles of TC (18 weeks).~Radiographic images were analyzed by a breast radiologist who looked at preoperative and postoperative breast mass imaging. If mass was smaller/less extensive, it was considered improved."|Every 2 months up to 3 years|Data were not available for 5 patients (4 withdrew and 1 did not have surgery).|||Participants|||Count of Participants
2741607|NCT00941330|Primary|Pathologic Complete Response|"Patients must have measurable disease by clinical examination.~Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.~If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists."|At time of definitive surgery|One patient in Arm B did not have surgery.|||Participants|||Count of Participants
2741608|NCT00941304|Secondary|Change From Baseline in Cognitive Assessment Using CNS-VS|"Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that lower score is better, otherwise higher scores are better."|Baseline (screening), 2 hours 15 minutes postdose|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||Score||Standard Deviation|Mean
2741609|NCT00941304|Secondary|"Percentage of Participants With Excellent Investigator Global Rating of Study Drug"|"Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to Overall, how would you rate the study medication for this subject?"|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||percentage of participants|||Number
2741610|NCT00941304|Secondary|"Percentage of Participants Reporting a Global Rating of Study Drug as Excellent"|"Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to Overall, how would you rate the study medication you received for pain?"|8 hours and 24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||percentage of participants|||Number
2741611|NCT00941304|Secondary|Duration of Analgesia|Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||hours||95% Confidence Interval|Median
2741612|NCT00941304|Secondary|Onset of Analgesia|Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||hours||95% Confidence Interval|Median
2741613|NCT00941304|Secondary|Peak Pain Relief|"Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain?"|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
2741614|NCT00941304|Secondary|Peak Pain Intensity Difference|"The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?"|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
2741615|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 2 Hours|"Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain? PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?"|2 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
2741616|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 8 Hours|"Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain? PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?"|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
2741617|NCT00941304|Secondary|Total Pain Relief Over 8 Hours|"Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain?"|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
2741618|NCT00941304|Primary|Sum of Pain Intensity Difference From Baseline to 8 Hours|"Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?"|Baseline, 8 hours|Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
2741619|NCT00941070|Post-Hoc|Progression Free Survival by Smoking Status|Percent of patients that were progression free by smoking status|at 18 months from study entry||||percentage of paticipants||95% Confidence Interval|Number
2741620|NCT00941070|Secondary|Progression Free Survival by HPV Subtype|Tabular descriptive data will be presented. HPV sub-type will be associated with treatment related toxicity, clinical response, PET metabolic response, and overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation will be used. Tests of equivalence of the estimates will be compared using the Wilcoxon long-rank test using a threshold for statistical significance of P 0.05. Cox proportional hazards regression models will be used in multivariate analyses.|Baseline||||percentage of patients||95% Confidence Interval|Number
2741621|NCT00941070|Secondary|Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling||18 months from study entry||||participants|||Number
2741622|NCT00941070|Secondary|Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire||Baseline to up to 5 years|Data were not collected as the study was terminated prior to the time period for collection.||||||
2741623|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Up to 5 years|Data were not collected as the study was terminated prior to the time period for collection.||||||
2741624|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|3 months post-treatment|Patients that completed 3-month 18F-FDG PET/CT|||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
2741625|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Baseline (pre-therapy)|Patients that completed the 3-month 18F-FDG PET/CT|||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
2741626|NCT00941070|Secondary|Progression-free Survival|Percentage of patients that did not have disease progression. Estimates of progression-free survival will be computed using the product-limit estimate of Kaplan and Meier.|at 18 months from study entry|Patients that completed the the 3-month 18F-FDG PET/CT.|||percentage of patients||95% Confidence Interval|Number
2741627|NCT00941070|Secondary|Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011|Information will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Frequency tables will be constructed to summarize observed incidence by severity and type of toxicity.|After 5 weeks of radiation therapy|All patients who receive at least one dose of Triapine® and cisplatin treatment.|||percentage of patients|||Number
2741628|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|three month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.|||participants|||Number
2741629|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|one month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.|||participants|||Number
2741630|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|post therapy at 3 months|Patients that completed the 3-month F-18 FDG study.|||participants|||Number
2741631|NCT00941070|Primary|Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.|To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.|post therapy at 3 months|1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.|||Standard uptake value (SUV)||Inter-Quartile Range|Median
2741632|NCT00941031|Secondary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo|The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).|13 weeks|Full analysis set|||Participants achieving goal|||Number
2741633|NCT00941031|Secondary|The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29||week 21 to 29|(Full analysis set, LOCF)|||Participants achieving goal|||Number
2741634|NCT00941031|Primary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.|Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment|13 weeks|(Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment|||Participants achieving goal|||Number
2741635|NCT00940992|Primary|Change in Inflammatory Lesion Counts From Baseline|The LS mean changes from Baseline in inflammatory lesion count at Week 12.|Baseline to Week 12 / end of treatment||||Inflammatory lesions||95% Confidence Interval|Least Squares Mean
2741636|NCT00940992|Primary|Investigator Global Assessment (IGA) Improvement From Baseline|The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).|Baseline to Week 12 / end of treatment||||percentage of subjects|||Number
2741637|NCT00940927|Primary|Effect Maximum (Emax)|Maximum percentage of predicted FEV1 effect|15 minutes after each dose||||percentage of predicted|||Number
2741638|NCT00940927|Primary|Effective Dose 50% (ED50)|ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol|15 minutes after each dose||||ug|||Number
2741639|NCT00940901|Primary|Greater Than or Equal to a 50% Reduction in Priapic Episodes|"A Priapism sexual activity log was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes."|change between 8 weeks post intervention and 16 weeks post intervention|3 participants from the Phase 1 Sildenafil group were lost to follow up during the second phase; 2 individuals from the Phase 1 Placebo then sildenafil group were lost to follow up during the second phase.|||Number of participants|||Number
2741640|NCT00940901|Primary|Greater Than or Equal to a 50% Reduction in Priapic Episodes|"A Priapism sexual activity log was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes."|change between baseline and 8 weeks post intervention|Intention to treat analysis.|||Number of participants|||Number
2741641|NCT00940888|Primary|Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector||5 years||||percentage of patients||90% Confidence Interval|Number
2741642|NCT00940888|Primary|Right Ventricle (RV) Bipolar Capture Thresholds||5 years|Study participants with RV bipolar capture threshold at the 5 year follow up visit.|||Volts||90% Confidence Interval|Mean
2741643|NCT00940875|Secondary|Duration of Response|Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|Data could not be summarized to be included in the data table because there are too few events to calculate a median and confidence intervals.||||||
2741644|NCT00940875|Secondary|Overall Survival (OS)|OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS|||weeks||95% Confidence Interval|Median
2741645|NCT00940875|Secondary|Percentage of Participants Who Died||BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS|||percentage of participants|||Number
2741646|NCT00940875|Secondary|Percentage of Participants With Non-Progression at Weeks 8 and 16|Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.|Weeks 8 and 16|FAS|||percentage of participants||95% Confidence Interval|Number
2741674|NCT00940498|Secondary|Change From Baseline in Serum Glucose at Day 2 of Cycle 1, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and End of Treatment||Baseline, Day 2 of Cycle 1, thereafter Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 (each cycle 28 days) , end of treatment visit (up to Cycle 14)|Serum biomarker analysis set included all enrolled participants who started treatment and had baseline and on-treatment serum biomarker samples successfully analyzed for at least 1 biomarker.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2741647|NCT00940875|Primary|PFS|The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)|FAS|||weeks||95% Confidence Interval|Median
2741648|NCT00940875|Secondary|Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.|BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS|||percentage of participants||95% Confidence Interval|Number
2741649|NCT00940875|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS|||percentage of participants|||Number
2741650|NCT00940823|Secondary|Number of Participants With Interventions After Surgery||5 years||||Participants|||Count of Participants
2741651|NCT00940823|Secondary|Number of Participants With Complications During or After Surgery||5 years||||Participants|||Count of Participants
2741652|NCT00940823|Secondary|LogMAR Snellen Visual Acuity|Visual acuity (VA) was tested monocularly (one eye at a time) using the manifest refraction adjusted for optical infinity using a standard Snellen Visual Acuity chart at 20 feet. Normal vision, or 20/20 vision, means that the participant can see at 20 feet what a healthy control can also see at 20 feet. Legal blindness, or 20/200 vision, means the participant can see at 20 feet what a healthy control can see at 200 feet. Hence, an increasing denominator implies visual impairment. Counting fingers was designated as 20/2000 vision, hand motions was 20/16000, light perception was 20/32000 and no light perception was 20/64000. To allow for appropriate statistical analysis, logMAR Snellen Visual Acuity was calculated using the formula: -logMAR (Snellen Acuity). This means that normal vision (20/20) would correspond to a value of 0, legal blindness (20/200) would correspond to a value of 1, and no light perception (20/64000) would correspond to 3.5.|5 years||||logMAR units on a scale||Standard Deviation|Mean
2741653|NCT00940823|Secondary|Anti-glaucoma Medications||5 years||||glaucoma medications||Standard Deviation|Mean
2741654|NCT00940823|Secondary|Intraocular Pressure (IOP)||5 years||||mmHg||Standard Deviation|Mean
2741655|NCT00940823|Primary|Number of Participants With Surgical Failure (Composite Measure)|"IOP out of target range (5-18 mmHg inclusive) or <20% reduction from baseline for 2 consecutive visits after 3 months.~De novo glaucoma surgery required (e.g., cyclodestructive procedure, additional tube shunt).~Removal of the implant.~Severe vision loss related to the surgery (endophthalmitis, suprachoroidal hemorrhage with vision loss, enucleation, evisceration, or phthisis bulbi) or progression to no light perception for any reason."|5 years||||participants|||Number
2741656|NCT00940771|Secondary|CD4 Count||4 Weeks, 12 weeks, 24 weeks||||cells/uL||Standard Deviation|Mean
2741657|NCT00940771|Secondary|Viral Load|Number of participants with undetectable viral load|4 weeks, 12 weeks, 24 weeks|Number of patients with undetectable viral load|||Participants|||Count of Participants
2741658|NCT00940771|Primary|Non-fasting Triglycerides||4 weeks, 12 weeks, 24 weeks||||mg/dL||Standard Deviation|Mean
2741659|NCT00940771|Primary|Non-fasting Cholesterol||4 Weeks, 12 weeks, 24 weeks||||mg/dL||Standard Deviation|Mean
2741660|NCT00940589|Secondary|Change From Baseline to 24 Weeks in MMSE|The Mini Mental State Examination (MMSE) is a brief assessment instrument used to assess cognitive function in elderly patients. The MMSE can be used to screen for cognitive impairment and as a measurement of cognition over time and with pharmacologic treatment. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention: the maximum score is 21. The second section tests the ability of the patient to name objects, follow verbal and written commands, write a sentence, and copy figures: the maximum score is 9. The scoring range for the MMSE is 0-30. Higher score represents better performance. MMSE was measured at base line and at end of treatment after 24 weeks.|24 weeks||||Scores on a scale||Standard Deviation|Mean
2741661|NCT00940589|Secondary|Change From Baseline to 24 Weeks in iADL|Instrumental Activities of Daily Living (iADL). The scale rates activities that represent key life tasks that people need to manage. These tasks are valuable for evaluating persons with early-stage disease, both to assess the level of disease and to determine the person's ability to care for himself or herself. Scores of 0 or 1 are given to every task (Bathing, Dressing, Tolieting, transferring, Continence and Feeding) to a total score of 6. , while 0 represents a patient who is very dependent and 6 represents patient who is independent. iADL was measured at base line and at end of treatment after 24 weeks.|24 weeks||||Scores on a scale||Standard Deviation|Mean
2741733|NCT00940017|Primary|Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
2741662|NCT00940589|Primary|Change From Baseline to 24 Weeks in ADAS-cog|ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a cognitive testing instrument used in clinical trials. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD. The test comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline. ADAS-cog was measured at base line and at end of treatment after 24 weeks.|24 weeks||||Scores on a scale||Standard Deviation|Mean
2741663|NCT00940576|Primary|Score of Crohn´s Disease and/or Ulcerative Colitis|score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), < 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.|8 weeks||||units on a scale||Standard Deviation|Mean
2741664|NCT00940576|Secondary|Extra-intestinal Pain|The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).|8 weeks||||Percentage of days with pain||Standard Deviation|Mean
2741665|NCT00940537|Secondary|T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water|T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences|baseline cross-sectional measurements|This analysis was per protocol.|||ratio||Standard Deviation|Mean
2741666|NCT00940537|Secondary|The Hepatic Triglyceride Content Pre- and Post-prandial.|We compared the intrahepatic triglyceride content in subjects after a 12 hour fast and 2 hours after eating a high fat, high carbohydrate meal. The measure reported here is for the pre and post prandial results given as the ratio of triglyceride signal to water signal. After showing its reliability, we chose to use the results from the optimized breath-hold sequence.|after a 12 hour fast and 2 hours post-prandial||||ratio||Standard Error|Mean
2741667|NCT00940537|Primary|The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS.|We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.|6 months||||coefficient of variation||Standard Error|Mean
2741668|NCT00940498|Secondary|Percentage of Participants With Objective Response (OR)|Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). Percentage of participants with objective response were reported.|Baseline until disease progression or death due to any cause (up to Cycle 14 [each cycle 28 days])|Response-evaluable population included participants who received at least 1 dose of study drug, had an adequate baseline tumor assessment and at least 1 post baseline disease assessment for analyses of response.|||percentage of participants||95% Confidence Interval|Number
2741669|NCT00940498|Secondary|Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue|Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were PIK3CA and phosphatase and tensin homolog (PTEN) by immunohistochemistry.|Baseline|Baseline tumor tissue biomarker analysis set: All enrolled patients who start treatment and had baseline tumor tissues successfully analyzed for at least one of the biomarkers. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2741670|NCT00940498|Secondary|Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 22|Tumor biopsies were taken from participants of reporting arm PF-05212384 154 mg dose level at baseline and at Cycle 1/Day 22. Biopsies were fixed in optimal cutting temperature compound and analyzed via RPMA. The biomarkers tested were phosphorylated versions of the proteins: AKT S473, AKT T308, FKHR T24 / FKHR1 T32, and STAT3. This outcome measure was planned to be analyzed only for the reporting arm Part 1 and 2: PF-05212384 154 mg, as pre-specified in protocol.|Baseline, Day 22 of Cycle 1|Tumor biopsy analysis set=all enrolled participants who had treatment &had baseline,on-treatment tumor tissue successfully analyzed for at least 1 biomarker.N=participants evaluable for this OM. This OM was planned to analyzed only in reporting arm- Part 1 and 2:PF-05212384 154 mg.|||normalized to cytokeratin (NFC)||Standard Deviation|Mean
2741671|NCT00940498|Secondary|Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 1|Analysis of hair follicles was conducted using a Reverse Phase Microarrays (RPMA) assay. Phosphoprotein biomarkers measured were pAkt S473, pAkt T308, pStat3 (Y705), Ki-67, and pPRAS40 (T246).|Baseline, 2, 3 and 72 hours (H) postdose on Day 1 of Cycle 1|Hair follicle analysis set. Here, N= participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for reporting arms: PF-05212384 10 mg, 21 mg, 43 mg, 89 mg, and 319 mg, as pre specified in protocol Amendment 5.|||normalized fluorescence units (NFU)||Standard Deviation|Mean
2741672|NCT00940498|Secondary|Change From Baseline in Serum C-peptide at Day 2 of Cycle 1, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and End of Treatment||Baseline, Day 2 of Cycle 1, thereafter Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 (each cycle 28 days) , end of treatment visit (up to Cycle 14)|Serum biomarker analysis set. Here, N= participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for reporting arms: PF-05212384 10 mg, 21 mg, 43 mg, 89 mg, and 319 mg, as pre specified in protocol Amendment 5.|||ng/mL||Standard Deviation|Mean
2741673|NCT00940498|Secondary|Change From Baseline in Serum Insulin at Day 2 of Cycle 1, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and End of Treatment||Baseline, Day 2 of Cycle 1, thereafter Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 (each cycle 28 days) , end of treatment visit (up to Cycle 14)|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure (OM).|||microunits per milliliter (mcU/mL)||Standard Deviation|Mean
2741734|NCT00939991|Secondary|Phase II: Number of Patients With Grade 2 or Greater, Treatment-related Toxicities|Phase II: Number of patients with grade 2 or greater, treatment-related toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years||||participants|||Number
2741675|NCT00940498|Secondary|Number of Participants With Maximum Increase From Baseline in Corrected QT Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Number of Participants with maximum increase from baseline in QTcB and QTcF of < 30 msec, between <=30 to <60 msec and >=60 were reported.|Baseline up to Cycle 14 (each cycle is 28 days)|The QTc analysis set included all enrolled participants who had at least one ECG assessment after receiving PF-05212384|||Participants|||Count of Participants
2741676|NCT00940498|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05212384: Single and Multiple Dose|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 168 hours (1 Week). For Cycle 2, the last PK sample for parameter calculations was on 120 hours after the Day 1 dose, however AUCtau was extrapolated to 168 hours using t1/2.|Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1|PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2741677|NCT00940498|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-05212384: Single Dose|AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf).|Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1|PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2741678|NCT00940498|Secondary|Plasma Decay Half-Life (t1/2) of PF-05212384: Single and Multiple Dose|Plasma decay half-life is the time measured for the plasma concentration of drug to decrease by one half.|Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1|PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated.|||hours (hr)||Standard Deviation|Mean
2741679|NCT00940498|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05212384: Single Dose|Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (Clast).|Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1|PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter(ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2741680|NCT00940498|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05212384: Single and Multiple Dose||Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1|PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2741681|NCT00940498|Primary|Recommended Phase-2 Dose (RP2D)|RP2D of PF-05212384 was determined based on the safety profile including laboratory and clinical assessments and pharmacodynamics findings.|Baseline up to Cycle 14 (each cycle is 28 days)|Safety analysis population included all participants who received at least 1 dose of study medication.|||mg|||Number
2741682|NCT00940498|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: Grade 3 nonhematologic AE (including nausea, vomiting, or diarrhea despite optimal therapy; or greater than or equal to [>=] grade 3 asthenia >2 days; or fasting serum glucose >250 milligrams per deciliter (mg/dL) despite optimal therapy); >=Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia lasting more than 7 days; Febrile neutropenia; other Grade 4 hematologic AE; delay of treatment >2 consecutive weeks due to toxicity. Grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Baseline up to Day 28|DLT evaluable analysis set included all enrolled participants who started treatment and did not have had a major treatment deviation in the first cycle of treatment.|||Participants|||Count of Participants
2741683|NCT00940498|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: hematology (hemoglobin [less than {<} 0.8*lower limit of normal {LLN}], platelets [<0.5*LLN or greater than {>} 1.75*upper limit of normal {ULN}], white blood cells [<0.6*LLN or >1.5*ULN], lymphocytes [<0.8*LLN or >1.2*ULN], total neutrophils [<0.8*LLN or >1.2*ULN], basophils, eosinophils, monocytes [>1.2*ULN]); coagulation [partial thromboplastin time, prothrombin (PT), PT international ratio [>1.1*ULN]); liver function (total bilirubin [>1.5*ULN], aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase [>0.3*ULN], total protein, albumin [<0.8*LLN or >1.2*ULN]).|Baseline up to Cycle 14 (each cycle is 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2741684|NCT00940498|Primary|Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Cycle 14, that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs included both serious and non-serious adverse events.|Baseline up to Cycle 14 (each cycle is 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2741685|NCT00940498|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Cycle 14, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Baseline up to Cycle 14 (each cycle is 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2741686|NCT00940485|Secondary|Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event|Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.|||Participants|||Number
2741687|NCT00940485|Secondary|Number of Participants With Incidence of Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.|||Participants|||Number
2741688|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time|Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.|||IU/ml||Standard Deviation|Mean
2741689|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time|Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.|||PEIU/ml)||Standard Deviation|Mean
2741690|NCT00940485|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase at Week 48|Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2741691|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48|Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2741692|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2741693|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48|Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2741694|NCT00940485|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48|Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2741695|NCT00940485|Primary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48|Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2741696|NCT00940446|Secondary|Participants With Wound Complications - Hematoma|Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.|up to 6 weeks post-op||||participants|||Number
2741697|NCT00940446|Primary|Participants With Incisional Drainage, Swelling or Gaps of Incision|Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.|Discharge from initial hospital stay (2-5 days post-op)||||participants|||Number
2741735|NCT00939991|Secondary|Phase II: Median Overall Survival (OS)|Phase II: Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|3 years||||months||95% Confidence Interval|Median
2741698|NCT00940342|Primary|Overall Response Rate|Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, <30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes < 4,000ul , Hemoglobin >11.0 g/dl , Platelets >1000,000/ul, Polymorphonuclear neutrophils (PMN) >1,500/ul, Liver/Spleen not palpable, Nodes none. PR is <30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes >50% decrease, Hemoglobin (un-transfused) > 11.0 g/dl or >50% improvement from baseline, Platelets > 100,000/ul or 50% improvement from baseline, PMN >1,500 ul or 50% improvement from baseline, Liver/Spleen >/= 50% decrease, Nodes >/= 50%.|Blood tests once a week during 8 weeks of treatment.||||Participants|||Count of Participants
2741699|NCT00940316|Post-Hoc|Progression Free Survival (PFS)|"Progression free survival will be measured every 8 weeks during treatment by CT or MRI scans. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST).~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks||||Months||95% Confidence Interval|Median
2741700|NCT00940316|Post-Hoc|Median Overall Survival|Median Overall Survival (OS) is measured from treatment initiation until death due to any cause.|From the time of first treatment to death||||Months||95% Confidence Interval|Median
2741701|NCT00940316|Secondary|Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition|Effect on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition. Skin biopsies will be performed at baseline (before the first days of treatment) and and at a time-point reflecting maximum rash intensity determined by a dermatologist.|At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles.|All patient data analyzed reported together regardless of arm allocation.This outcome measure was based on optional biopsies that patients were required to consent to. Data was not collected or analyzed for this outcome measure.||||||
2741702|NCT00940316|Secondary|Toxicity of the Combination of Study Drugs|"Data on the toxicity of the combination of study drugs is assessed by laboratory blood draws done on day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 3 and grade 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected using National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). AEs are graded as:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles.||||participants|||Number
2741703|NCT00940316|Secondary|Time to Treatment Failure|Time to treatment failure will be measured as the time elapsed from the day of first study drug administration to the date a subject stops all study drugs for any reason.|From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeks|Data was not collected and analyzed for this outcome measure||||||
2741704|NCT00940316|Secondary|Time to Disease Progression|"Time to disease progression will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression . Time to disease progression will be defined as the time elapsed from the day of 1st study drug administration to the day disease progression is documented or death occurs and will .~Progressive Disease will be defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) : At least a 20% increase in the sum of the longest diameter (LD) of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks|All patient data analyzed reported together regardless of arm allocation. Data not collected and analyzed for this outcome measure.||||||
2741705|NCT00940316|Primary|Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)|"Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.||||Participants|||Count of Participants
2741706|NCT00940290|Primary|Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication|"A fictitious clinical case of a child with acute diarrhea was presented. The physician read the case and then answered the question would you recommend racecadotril to this patient? A zero to 10 visual-analog scale and a Likert scale were used to measure the decision of the physician related to the clinical case presented (from zero=definitely no to 10=definitely yes). Mean differences before-after and among groups were measured on the 10 centimeters scale."|One day||||Mean change in centimeters||95% Confidence Interval|Mean
2741707|NCT00940108|Secondary|Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination|Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.|During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2743461|NCT00928018|Primary|To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil||2 years||||percentage of participants||95% Confidence Interval|Number
2741708|NCT00940108|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741709|NCT00940108|Secondary|Duration of Solicited AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
2741710|NCT00940108|Secondary|Duration of Solicited AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
2741711|NCT00940108|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.|During the 7 days after each vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741712|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741713|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741714|NCT00940108|Primary|GMFI in the HI Antibody Titre After the Second Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2741715|NCT00940108|Primary|Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2741716|NCT00940108|Primary|HI Antibody Titre Seroconversion Rate After the Second Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741717|NCT00940108|Primary|Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741718|NCT00940017|Primary|Concentration Ratio in ELF to Plasma|Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Subjects randomized to a single BAL procedure timepoint; bronchoscopy and BAL done for 5 different subjects at each timepoint.|||ratio||Standard Deviation|Mean
2741757|NCT00939822|Primary|Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP|"Change in CSF beta-amyloid-42 was defined as the ratio of 18-month levels to baseline levels.~Beta-amyloid-42 is a substance found in the plaques in the brain of people with Alzheimer's disease and can be detected in CSF. There is no defined normal range yet for middle-aged adults."|Baseline and 18 months||||ratio||95% Confidence Interval|Mean
2741719|NCT00940017|Primary|Overall Drug Penetration Ratio in ELF|ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average ELF to plasma ratio|||Number
2741720|NCT00940017|Primary|AM: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in AM did not allow calculation of t1/2; not analyzed.|||hours|||Number
2741721|NCT00940017|Primary|AM: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug*hr/mL)|||Number
2741722|NCT00940017|Primary|AM: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||hours|||Number
2741723|NCT00940017|Primary|Alveolar Macrophages (AM): Cmax|Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug/mL)|||Number
2741724|NCT00940017|Primary|ELF PK: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in ELF did not allow calculation of t1/2; not analyzed.|||hours|||Number
2741725|NCT00940017|Primary|ELF PK: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug*hr/mL)|||Number
2741726|NCT00940017|Primary|ELF PK: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||hours|||Number
2741727|NCT00940017|Primary|Epithelial Lining Fluid (ELF) PK: Cmax|Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug/mL)|||Number
2741728|NCT00940017|Primary|Plasma PK: Volume of Distribution at Steady-state (Vss)|Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean.|||L||Standard Deviation|Mean
2741729|NCT00940017|Primary|Plasma PK: Total Clearance (CL Total)|CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population|||mL/min||Standard Deviation|Mean
2741730|NCT00940017|Primary|Plasma PK: Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean|||hours||Standard Deviation|Mean
2741731|NCT00940017|Primary|Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest.|||ug*hr/mL||Standard Deviation|Mean
2741732|NCT00940017|Primary|Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population|||hours||Full Range|Median
2741736|NCT00939991|Secondary|Phase II: Median Progression-free Survival (PFS)|Phase II: Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|3 years||||months||95% Confidence Interval|Median
2741737|NCT00939991|Secondary|Phase II: Radiographic Response.|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria. A confirmation of response was not required. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments were done at baseline, the end of the first cycle (4 weeks), then the end of every second cycle (every 8 weeks) thereafter.|3 years||||percentage of participants||95% Confidence Interval|Number
2741738|NCT00939991|Primary|Phase II: 6-month Progression-free Survival (PFS)|Phase II: Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months||||percentage of participants||95% Confidence Interval|Number
2741739|NCT00939991|Primary|Phase I: Determination of the Maximum Tolerated Dose (MTD)|The MTD is based upon dose-limiting toxicities (DLTs) experienced during Cycle 1 of treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with at least two patients experiencing DLT at the next higher dose level. Using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, DLTs are defined as: Grade 4 neutropenia lasting greater than 5 days; Grade 3 thrombocytopenia; the occurrence of non-hematologic Grade 3 or greater drug-related adverse events excluding Grade ≥ 3 elevation in alkaline phosphatase, Grade ≥ 3 nausea or vomiting unless occurring despite the use of standard anti-emetics or Grade 3 diarrhea unless occurring despite standard anti-diarrheal therapy; > 14 day delay to re-treat due to failure to resolve drug-related toxicity to re-treatment criteria or pre-treatment baseline.|Cycle 1 (28 days)||||mg|||Number
2741740|NCT00939952|Primary|Residual Drug in Peritoneal Cavity After 1st Exchange||6h||||mg||Standard Deviation|Mean
2741741|NCT00939952|Primary|k31|1st order intercompartmental rate constant peritoneal cavity to central|12h||||h^(-1)||Standard Deviation|Mean
2741742|NCT00939952|Primary|k13|1st order intercompartmental rate constant from central to peritoneal cavity|12h||||h^(-1)||Standard Deviation|Mean
2741743|NCT00939952|Primary|k21|1st order intercompartmental rate constant from peripheral to central compartment|12h||||h^(-1)||Standard Deviation|Mean
2741744|NCT00939952|Primary|k12|1st order intercompartmental rate constant between central and peripheral compartments|12h||||h^(-1)||Standard Deviation|Mean
2741745|NCT00939952|Primary|Clearance (CL)|population PK clearance|12h||||Liters/hour (L/h)||Standard Deviation|Mean
2741746|NCT00939952|Primary|Volume of Distribution, Central Compartment (Vc)|Population PK|12h||||Liters (L)||Standard Deviation|Mean
2741747|NCT00939900|Secondary|Time to Total Arthroplasty or Joint Preserving Surgery||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
2741748|NCT00939900|Secondary|Time to Collapse of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
2741749|NCT00939900|Secondary|Change of HHS (Harris Hip Scores), WOMAC Score, SF-36||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
2741750|NCT00939900|Secondary|Collpase Rate of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
2741751|NCT00939900|Primary|Number of Participants With Femoral Head Collapse Within 24 Months||Measurements were done at 6, 12, 24 months||||participants|||Number
2741752|NCT00939874|Secondary|Percentage of Participants With HIV Viral Load <50 Copies/mL|Plasma HIV viral load remained <50 copies/mL|from Baseline to Week 96|Week 96 data were available for 32 completed participants|||percentage of participants|||Number
2741753|NCT00939874|Primary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips|Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96|from Baseline to Weeks 48 and 96|Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures.|||percent change||95% Confidence Interval|Mean
2741754|NCT00939822|Secondary|Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP|"Changes in CSF t-tau and p-tau were defined as the ratio of 18-month levels to baseline levels.~T-tau and p-tau are substances found in the brain that can provide information on nerve cell health in the brain and tangle formation in nerve cells."|Baseline and 18 months||||ratio||95% Confidence Interval|Mean
2741755|NCT00939822|Secondary|Changes in CSF Soluble Alpha Precursor Proteins (sAPP-alpha) and Soluble Beta Precursor Proteins (sAPP-beta) as Measured by Duplex|"Changes in CSF sAPP-alpha and sAPP-beta were defined as the ratio of 18-month levels to baseline levels.~sAPP-alpha and sAPP-beta are components of beta-amyloid that provide information on beta-amyloid breakdown."|Baseline and 18 months||||ratio||95% Confidence Interval|Mean
2741756|NCT00939822|Secondary|Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) )|"Change in CSF beta-amyloid-40 was defined as the ratio of 18-month levels to baseline levels.~Beta amyloid-40 is a substance found in the brain vessels of individuals with Alzheimer's disease and has more potent cerebrovascular effects on individuals with Alzheimer's disease than any other form of beta amyloid."|Baseline and 18 months||||ratio||95% Confidence Interval|Mean
2741758|NCT00939809|Secondary|Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs)|Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs. Data was not collected.|Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing.|due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.||||||
2741760|NCT00939809|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
2741761|NCT00939809|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Every cycle during treatment (average collection time = 4 months)|Eligible and Treated Patients|||Participants|||Count of Participants
2741762|NCT00939809|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
2741763|NCT00939809|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
2741764|NCT00939796|Secondary|Tube Retention|Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).|two weeks post-procedure||||retained tubes|Participants||Number
2741765|NCT00939796|Secondary|Cross-Over to Manual Myringotomy and Tube Placement|Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.|at procedure visit||||number of ears|Participants||Number
2741766|NCT00939796|Primary|Device Success|Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).|At procedure visit|All TTDS devices attempted|||devices|Participants||Number
2741767|NCT00939783|Secondary|Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >450 to <=480, >480 to <=500 and >500 msec, increase of >30 to <=60 and >60 msec for QT interval corrected using Fridericia's formula (QTcF).|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.|||Percentage of participants|||Number
2741768|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was >=1 in qualitative test of all parameters except red and white blood cells which were reported if result was >=6, indicating levels in urine were abnormal. Urine pH abnormality reported if >8 and urine specific gravity abnormality if <1.003 or >1.030.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular laboratory parameter.|||Percentage of participants|||Number
2741769|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Vital Signs|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline for systolic BP; absolute diastolic BP <50 mmHg with maximum increase or decrease of >=20 mmHg from baseline and absolute heart rate values <40 beats per minute (bpm), >120 bpm for supine or sitting measurement, >140 bpm for standing measurement.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.|||Percentage of participants|||Number
2741770|NCT00939783|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.|||Percentage of participants|||Number
2741771|NCT00939731|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
2741772|NCT00939731|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2741773|NCT00939731|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2741774|NCT00939731|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2741775|NCT00939731|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
2741776|NCT00939731|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2741777|NCT00939731|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2741778|NCT00939705|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.|||ng h / ml|Participants|Standard Deviation|Mean
2741779|NCT00939705|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.|||ng h / ml|Participants|Standard Deviation|Mean
2741780|NCT00939705|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.|||ng / ml|Participants|Standard Deviation|Mean
2741781|NCT00939692|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.||||ng·h/mL||Standard Deviation|Mean
2741782|NCT00939692|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.||||mcg*hr/mL||Standard Deviation|Mean
2741783|NCT00939692|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.||||ng/ml||Standard Deviation|Mean
2741784|NCT00939653|Primary|Death|Number of participants who died.|From the first dose of study therapy until 30 days after last therapy dose||||Participants|||Count of Participants
2741785|NCT00939653|Primary|Achievement of Complete Remission (CR) at Reinduction|Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count.|Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recovered|Patients that completed at least 1 treatment course of study drug.|||Participants|||Count of Participants
2741786|NCT00939640|Other Pre-specified|Estimated Glomerular Filtration Rate, Serum Potassium, Serum Calcium-phosphorus Product|Safety measures to determine adverse effects of the provided DASH diet home-delivered meals|Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation|||||||
2741787|NCT00939640|Other Pre-specified|EndoPAT Arterial Endothelial Function||Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation|||||||
2741788|NCT00939640|Secondary|Urinary 8-isoprostanes||Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||mmol F2-iso/mmol Cr||Standard Deviation|Mean
2741789|NCT00939640|Secondary|Six Minute Walk Test Distance||Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||meters||Standard Deviation|Mean
2741790|NCT00939640|Secondary|Ventricular Diastolic Function|Lateral mitral annulus E/e' ratio|Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||ratio||Standard Deviation|Mean
2741791|NCT00939640|Secondary|Carotid-femoral Pulse Wave Velocity||Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||m/s||Standard Deviation|Mean
2741792|NCT00939640|Secondary|Aortic Augmentation Index|Aortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease.|Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||percentage||Standard Deviation|Mean
2741793|NCT00939640|Secondary|Diurnal Variation in Ambulatory Blood Pressure|Number of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of >= 0.9|Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||Participants|||Count of Participants
2741794|NCT00939640|Secondary|Mean 24-hour Systolic Blood Pressure|Change in 24-hour systolic blood pressure|Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||mm Hg||Standard Deviation|Mean
2741795|NCT00939640|Primary|Brachial Artery Flow-mediated Dilation (FMD)||Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation||||% dilation||Standard Deviation|Mean
2741796|NCT00939627|Other Pre-specified|Quality of Life|Quality of Life Survey results.|up to 3 years|Data were not collected as The Quality of Life survey instrument was not completed by study participants..||||||
2741797|NCT00939627|Secondary|Overall Survival Associated With Immunomodulatory Cytokines|Twelve immunomodulatory cytokines were selected based on previous a feasibility study and detected using multiplex Luminex bead assays from patient's plasma. One cytokines, HGF, was eliminated due to extremely low expression. Three representative cytokines, TGF-beta 1, IL-8 and VEGF were to be evaluated for association with survival due to clustering.|Pre-therapy, up to about 42 months (follow-up for overall survival)|Data were not collected due to an insufficient amount of tumor tissue available.||||||
2741798|NCT00939627|Secondary|Gene Expression Levels|Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when >70% cells stained, otherwise negative) were to be described using frequencies.|Pre-therapy|Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.||||||
2741799|NCT00939627|Secondary|Number of Participants With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.|||participants|||Number
2741800|NCT00939627|Secondary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On-study date to date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||months||95% Confidence Interval|Median
2741801|NCT00939627|Secondary|Best Response|"Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.~Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On-treatment date to date of disease progression (assessed up to 3 years)|All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.|||participants|||Number
2741802|NCT00939627|Primary|Progression Free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off-study date or last known alive date.|||months||95% Confidence Interval|Median
2741803|NCT00939562|Primary|Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline|AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|PK|||ug*hr/mL||Standard Deviation|Mean
2741804|NCT00939562|Primary|Maximum Plasma Concentration (Cmax) of Doxycycline||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|The pharmacokinetic (PK) concentration population was defined as all subjects randomized and treated who had at least 1 concentration in at least 1 treatment period.|||ug/mL||Standard Deviation|Mean
2741805|NCT00939536|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||mcg*hr/mL||Standard Deviation|Mean
2741806|NCT00939536|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||mcg*hr/mL||Standard Deviation|Mean
2741807|NCT00939536|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng/ml||Standard Deviation|Mean
2741808|NCT00939523|Secondary|ErbB Receptor Expression|Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib|at 6 months|Of the subjects who participated in the trial, only 3 had available tumor tissue to immunostain. Therefore, results could not be reported on the other subjects.|||percent positive expression||Standard Deviation|Mean
2741809|NCT00939523|Secondary|% Change in Prolactin From Baseline to Study End|Percent prolactin change from start of lapatinib to end of study participant participation|Baseline and at 6 months|Prolactin results only reported on the 6 prolactinomas in the trial and not for the nonfunctioning tumors.|||percent change in prolactin||Full Range|Median
2741810|NCT00939523|Primary|Number of Participants With 50% Reduction in Prolactin Levels|50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.|every month, up to 6 months|There were 6 prolactinomas and 3 nonfunctioning tumors in this trial. Prolactin results are only reported for the prolactinomas.|||Participants|||Count of Participants
2741811|NCT00939523|Primary|Change in Tumor Volume|Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.|baseline and at 6 months|Note: 1 subject was withdrawn after 6 weeks of lapatinib therapy and therefore not included in analysis. A 2nd subject was not included in this analysis as the drug was given on compassionate basis to prevent recurrence of her tumor. She had a negative baseline MRI and maintained a negative MRI at study end.|||Percent volume||Full Range|Median
2741812|NCT00939510|Primary|RECIST-defined Measurable Disease|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks|every 8 weeks and at end of treatment|12 patients had RECIST-defined measurable disease. One patient came off study early for toxicity and therefore was not evaluable.|||participants|||Number
2741813|NCT00939510|Secondary|Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study|The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.|every 28 days for first 3 cycles, end of study|All patients that received treatment|||participants|||Number
2741814|NCT00939510|Primary|Number of Patients With a PSA Response|Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.|reevaluated for response every eight weeks|All patients that received treatment.|||participants|||Number
2741815|NCT00939484|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data|||ratio||Full Range|Median
2741816|NCT00939484|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patients with sustained objective response|||months||Full Range|Median
2741817|NCT00939484|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years||||months||95% Confidence Interval|Median
2741818|NCT00939484|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months||||proportion of participants||95% Confidence Interval|Number
2741819|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SNOT-20)|Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).|||change in SNOT-20 score||Standard Deviation|Mean
2741820|NCT00939471|Secondary|Revision Rate|The number of subjects requiring revisions out of 33 subjects treated.|at 1 year||||participants|||Number
2741821|NCT00939471|Secondary|Days Out of School During the 12 Months of Follow-up|Quantitative assessment of days out of school during the 12 months of follow-up.|12 months||||days||Standard Deviation|Mean
2741822|NCT00939471|Secondary|Effectiveness of Dilation/Measured by Post-op Interventions|Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.|12 months||||number of interventions|||Number
2741823|NCT00939471|Secondary|Effectiveness: Medication Thru 1 yr|Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.|12 months||||percentage of participants|||Number
2741824|NCT00939471|Secondary|Device Success: Ability to Access/Dilate Sinus Ostia|Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.|12 months|intent to treat analysis|||percentage of sinuses successful|sinuses||Number
2741825|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SN-5)|Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).|||change in SN-5 score||Standard Deviation|Mean
2741826|NCT00939471|Primary|Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months|Number of device-related adverse events from time of procedure through 12 months post-procedure.|12 months||||number of events|||Number
2741827|NCT00939393|Primary|Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|24 weeks|Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2741828|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|52 weeks|Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2741829|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|4 weeks|Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2741830|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 week|Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2743991|NCT00924560|Secondary|Change From Baseline in Serum Deoxypyridinoline||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||nmol/L||Standard Deviation|Mean
2741831|NCT00939393|Secondary|Proportion of Participants With Post-operative Sinus Infections|Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).|52 weeks||||participants|||Number
2741832|NCT00939393|Secondary|Proportion of Participants With Revisions (IO Only)|After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.|52 weeks||||participants|||Number
2741833|NCT00939393|Secondary|Mean Number of Debridements Per Participant (IO Only)|A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.|52 weeks||||debridements||Standard Deviation|Mean
2741834|NCT00939393|Secondary|Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)|Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.|Day 0|One (1) In-Office subject was missing data for this outcome measure.|||participants|||Number
2741835|NCT00939393|Secondary|Proportion of Participants Rating Procedure as Tolerable (IO Only)|Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.|Day 0|Eight (8) In-Office subjects were missing data for this outcome measure.|||participants|||Number
2741836|NCT00939393|Secondary|Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]|The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.|24 weeks|Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2741837|NCT00939367|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng.hr/mL||Standard Deviation|Mean
2741838|NCT00939367|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng.hr/mL||Standard Deviation|Mean
2741839|NCT00939367|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng/mL||Standard Deviation|Mean
2741840|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks||||Percentage of days||Standard Deviation|Mean
2741841|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks||||Percentage of days||Standard Deviation|Mean
2741842|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks||||Percentage of days||Standard Deviation|Mean
2741843|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period|Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time|Baseline and 12 weeks||||Number of inhalations||Standard Deviation|Mean
2741844|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period|Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks||||Number of inhalations||95% Confidence Interval|Mean
2741845|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period|Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks||||Number of inhalations||95% Confidence Interval|Mean
2743714|NCT00926393|Secondary|Number of Patients With Potential Somnolence|Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence|From start of the study treatment to last dose plus 30 days||||Patients|||Number
2741846|NCT00939341|Secondary|Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline|Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
2741847|NCT00939341|Secondary|Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline|Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
2741848|NCT00939341|Secondary|Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
2741849|NCT00939341|Secondary|Change in AQLQ (S) Domain (Symptom) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
2741850|NCT00939341|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
2741851|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
2741852|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
2741853|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
2741854|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (India)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
2741855|NCT00939341|Secondary|Change in ACQ(5) Score From Baseline at Country Level (China)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
2741856|NCT00939341|Primary|Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
2741857|NCT00939211|Secondary|Plasma AZD9164 AUC0-24|Area under the AZD9164 plasma concentration curve|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h||||nmol*h/L||Full Range|Geometric Mean
2741858|NCT00939211|Secondary|Plasma AZD9164 Cmax|Maximum plasma concentration of AZD9164|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h||||nmol/L||Full Range|Geometric Mean
2741859|NCT00939211|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value|0, 30 min, 2 h, 4 h||||ms||Standard Deviation|Mean
2741860|NCT00939211|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h||||bpm||Standard Deviation|Mean
2741861|NCT00939211|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h||||bpm||Standard Deviation|Mean
2741871|NCT00939185|Secondary|Compliance|"Compliance was assessed by the following questions: Question 1: Were the pediatrician's instructions during the treatment phase followed (i.e. dose, frequency and number of days)?; Question 2: Was it easy to understand your pediatrician's instructions regarding treatment?; and Question 3: Was the administration of this drug easier than any other previously used drug? Patients could answer either yes, no, or Not applicable (NA)."|3 to 7 days after receiving treatment|Safety population|||participants|||Number
2741872|NCT00939185|Secondary|Number of Subjects Who Withdrew From the Study||3 to 7 days after receiving treatment|Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability.|||participants|||Number
2741873|NCT00939185|Primary|Number of Patients With Adverse Events (AEs)|All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.|3 to 7 days after receiving treatment|Safety population = Those subjects who were known to have received at least one dose of the study treatment. Subjects who were dispensed study treatment and immediately lost to follow-up were not included among those known to have been dosed.|||participants|||Number
2741874|NCT00939159|Primary|Overall Response Rate Based on the Hematologic Improvement|"Overall response rate defined by International Working Group (IWG) response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets:~absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence ."|Assessment with 28-day cycle until response, then every 3 cycles as needed, for up to 24 months|Of the seventeen participants registered, four were not treated making thirteen evaluable for response.|||Percentage of Participants|||Number
2741875|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Storage Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
2741876|NCT00939120|Secondary|International Prostate Symptoms Score, Voiding Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
2741877|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Total|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
2741878|NCT00939120|Secondary|Patient Perception of Bladder Condition (PPBC)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
2741879|NCT00939120|Primary|Acute Urinary Retention (AUR)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||participants|||Number
2741880|NCT00939120|Primary|Urine Voided Volume (Voiding)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||mL||Standard Error|Mean
2741881|NCT00939120|Primary|Maximum Urine Flow Rate (Qmax).|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||mL/sec||Standard Error|Mean
2741882|NCT00939120|Secondary|Overactive Bladder Questionnaire (OABq)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
2741883|NCT00939120|Primary|Post-void Residual (PVR) Volume|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||mL||Standard Error|Mean
2741884|NCT00939107|Primary|Number of Patients With Treatment Success|Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)|Two months posttreatment|Intention to treat|||participants|||Number
2741885|NCT00939107|Secondary|Cost Effectiveness||twelve months posttreatment||2010-08-31|08/2010||||
2741888|NCT00939107|Secondary|Pain|The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items).|twelve months posttreatment||||Units on a scale||95% Confidence Interval|Mean
2741889|NCT00939107|Primary|Disability|Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).|two months after treatment|Intention to treat|||Units on a scale||95% Confidence Interval|Mean
2741890|NCT00939094|Secondary|Change in BPI-SF Pain Interference From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.|28 days||||Scores on BPI-SF pain interference||Standard Error|Least Squares Mean
2741891|NCT00939094|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.|28 days||||Scores (units) on BPI-SF pain severity||Standard Error|Least Squares Mean
2741892|NCT00939094|Secondary|Change in SF-MPQ Affective Index From Baseline to Day 28|"Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days||||Scores (units) on SF-MPQ Affective Index||Standard Deviation|Least Squares Mean
2741893|NCT00939094|Secondary|Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28|"Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days||||Scores (units) on SF-MPQ Sensory Index||Standard Error|Least Squares Mean
2741894|NCT00939094|Secondary|"Patients With Patient Global Impression of Change (PGIC) Score of at Least Much Improved (Responder Rate) at Day 28"|"PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of  much improved or very much improved Responder rate=(no. of responders/total no. of patients)*100"|28 days||||Patients|||Number
2741895|NCT00939094|Secondary|Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100|28 days||||Participants|||Number
2741896|NCT00939094|Secondary|Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100|28 days||||Participants|||Number
2741897|NCT00939094|Primary|Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment|Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.|Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)||||Scores (units) on NRS||Standard Error|Least Squares Mean
2741898|NCT00939055|Secondary|Quality of Life|Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will represent a clinically significant improvement.|12 months|Secondary endpoint was not analyzed.||||||
2741899|NCT00939055|Primary|Weight Loss|A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.|12 month|When futility analysis was performed, only 46 out of 108 patients had reached the 12 month primary endpoint. Analysis was performed on the 29 StomaphyX-treated patients to determine whether study objectives were met. Sham (control) patients were not analyzed.|||participants|||Number
2741900|NCT00939029|Secondary|Point-prevalence Abstinence at 6 Months|7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.|week 24|intention to treat|||participants|||Number
2741901|NCT00939029|Secondary|Point-prevalence Abstinence at 3 Months|7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml|week 12|intention to treat|||participants|||Number
2741902|NCT00939029|Primary|End of Treatment (Week 8) Point Prevalence Abstinence|7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml|weeks 8|intention to treat|||participants|||Number
2741903|NCT00939003|Other Pre-specified|Number of Participants Achieving a BASDAI50 Response During the Open-label Period|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)|||participants|||Number
2741927|NCT00938964|Secondary|Change in the Cognitive Difficulties Scale|"Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are I forget errands I planned to do and I fail to recognize people I know. Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741904|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS40 Response During the Open-label Period|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale of 0 to 100) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)|||participants|||Number
2741905|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS20 Response During the Open-label Period|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (as indicated by N)|||participants|||Number
2741906|NCT00939003|Secondary|Change From Baseline in SPARCC MRI Score for the Spine|"Six discovertebral units (DVU) representing the 6 most abnormal DVUs, and 3 consecutive sagittal slices at each DVU representing the most abnormal slices for that DVU were selected for scoring. Each DVU was divided into 4 quadrants and scored for the presence (1) or absence (0) of edema. The maximum score is 12 per DVU. The maximum score is 72 for 6 DVUs.~If edema was present in at least 1 quadrant of a DVU slice, it was scored for intensity and depth of the edema representing that slice:~A score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. The maximum score for intensity per slice is 1, per DVU is 3 and for 6 DVUs is 18.~A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the surface of the endplate in any quadrant. The maximum score per slice is 1, for a DVU is 3 and for 6 DVUs is 18.~The total maximum SPARCC score for all 6 DVUs is 108."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.|||units on a scale||Standard Deviation|Mean
2741907|NCT00939003|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints|"Six consecutive sacroiliac (SI) joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema using SPARCC scoring.~Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema; the maximum score is 8 per slice and maximum score for 6 SI joint slices is 48.~Intensity of edema: A score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice. The maximum score is 2 per slice and 12 for 6 slices.~A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The maximum score per slice is 2 and for 6 slices 12.~The total maximum score for all SI joints across 6 slices is 72."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.|||units on a scale||Standard Deviation|Mean
2741908|NCT00939003|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)|C-reactive protein (CRP) is considered an efficacy variable for the axial spondyloarthritis indication. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response. Higher levels indicate more inflammation.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline value were included. Last observation carried forward was used.|||mg/L||Standard Deviation|Mean
2741909|NCT00939003|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline values were included. Last observation carried forward was used.|||units on a scale||Standard Deviation|Mean
2741928|NCT00938964|Secondary|Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)|"Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., Could you prepare your own meals? Could you drive a car?). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741910|NCT00939003|Secondary|Number of Participants Achieving an ASAS5/6 Response|"ASAS5/6 response is a 20% improvement in five out of the following six domains:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).~Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~C-reactive protein level (lower levels indicate less inflammation)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
2741911|NCT00939003|Other Pre-specified|Number of Participants With Blood Hematology or Chemistry Values Common Toxicity Criteria Grade ≥ 3|Blood was collected for analysis at designated study visits; hematology and chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher then upper normal limit or lower than lower normal limit) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. Results for the double-blind phase phase of the study are reported through Week 12.|||participants|||Number
2741912|NCT00939003|Other Pre-specified|Number of Participants Reporting Adverse Events|Adverse events were collected at designated study visits for all participants who received at least 1 dose of study drug. The number of participants experiencing any adverse event (serious and non-serious) is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. For the double-blind phase of the study, adverse events are reported through Week 12.|||participants|||Number
2741913|NCT00939003|Secondary|Number of Participants Achieving ASAS Partial Remission|"ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
2741914|NCT00939003|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life. The SF-36 consists of 36 questions in 8 domains (limitations in physical functioning due to health problems; limitations in usual role because of physical health problems; bodily pain; general health perceptions; vitality; limitations in social functioning because of physical or emotional problems; limitations in usual role due to emotional problems; and general mental health). Two component scores can be summarized: physical and mental; domains 1-4 comprise the physical component summary of the SF-36. A transformed summary score is calculated ranging from 0 to 100 where higher scores indicate a higher level of functioning. A positive change from Baseline score indicates an improvement.|Baseline and Week 12|Full analysis set with available data|||units on a scale||Standard Deviation|Mean
2741915|NCT00939003|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
2741916|NCT00939003|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
2741929|NCT00938964|Secondary|Change in the Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL)|"Duke Older Americans Resources and Services Procedures- Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., Could you prepare your own meals? Could you drive a car?). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741985|NCT00938639|Secondary|Frequency and Intensity of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741917|NCT00939003|Primary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale from 0 to 100) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set. Participants with missing data at Week 12 were counted as non-responders (non-responder imputation).|||participants|||Number
2741918|NCT00938964|Secondary|Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)|The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741919|NCT00938964|Secondary|Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)|The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741920|NCT00938964|Secondary|Change in Study 36-Item Short Form Health Survey (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741921|NCT00938964|Secondary|Change in Study 36-Item Short Form Health Survey (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741922|NCT00938964|Secondary|Change in Social Activity|"Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are How often do you talk on the telephone with friends and relatives? and How often do you attend meetings of social groups, clubs, or civic organizations? Scores range from 8 to 32. A lower score indicates more social activity."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741923|NCT00938964|Secondary|Change in Social Activity|"Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are How often do you talk on the telephone with friends and relatives? and How often do you attend meetings of social groups, clubs, or civic organizations? Scores range from 8 to 32. A lower score indicates more social activity."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741924|NCT00938964|Secondary|Change in Perceived Social Support|"Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is a special person who is around when I am in need and my family really tries to help me. Choices range from very strongly disagree to very strongly agree. Items are summed for a range of 12 to 84, with a high score meaning more social support."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741925|NCT00938964|Secondary|Change in Perceived Social Support|"Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is a special person who is around when I am in need and my family really tries to help me. Choices range from very strongly disagree to very strongly agree. Items are summed for a range of 12 to 84, with a high score meaning more social support."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741926|NCT00938964|Secondary|Change in the Cognitive Difficulties Scale|"Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are I forget errands I planned to do and I fail to recognize people I know. Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741930|NCT00938964|Secondary|Change in Symptom Limitations|Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741931|NCT00938964|Secondary|Change in Symptom Limitations|Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741932|NCT00938964|Secondary|Change in Spielberger State Anxiety Inventory (STAI)|"Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as I feel nervous and I feel worried. These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from not at all to very much so. Scores range from 20 to 80, with higher scores indicating greater anxiety."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741933|NCT00938964|Secondary|Change in Spielberger State Anxiety Inventory (STAI)|"Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as I feel nervous and I feel worried. These items are rated on a 4-point scale, based on how well they describe the patient's current or typical mood, from not at all to very much so. Scores range from 20 to 80, with higher scores indicating greater anxiety."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741934|NCT00938964|Secondary|Change in Center for Epidemiological Studies Depression Scale (CES-D)|"Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as I had crying spells and I felt lonely. Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741935|NCT00938964|Secondary|Change in Center for Epidemiological Studies Depression Scale (CES-D)|"Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as I had crying spells and I felt lonely. Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741936|NCT00938964|Secondary|Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741937|NCT00938964|Secondary|Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741938|NCT00938964|Secondary|Change in Duke Activity Status Index (DASI)|"The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done with no difficulty receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function."|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741939|NCT00938964|Secondary|Change in Duke Activity Status Index (DASI)|"The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done with no difficulty receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function."|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
2741984|NCT00938639|Secondary|Duration of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
2741940|NCT00938964|Secondary|Change in Cognitive Function From Baseline|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement|1 year after surgery|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
2741941|NCT00938964|Secondary|Transcerebral Activation Gradient of Platelet-neutrophil Conjugates|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects.|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
2741942|NCT00938964|Secondary|Transcerebral Activation Gradients of Monocytes|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects.|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
2741943|NCT00938964|Secondary|Transcerebral Activation Gradients of Neutrophils|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
2741944|NCT00938964|Secondary|Transcerebral Activation Gradients of Platelets|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
2741945|NCT00938964|Primary|Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.|Preoperative to 6 weeks after surgery||||Participants|||Count of Participants
2741946|NCT00938964|Primary|Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.|Preoperative to 6 weeks after surgery||||units on a scale||Standard Deviation|Mean
2741947|NCT00938886|Secondary|7-day Point Prevalence Smoking Abstinence|Self-report abstinence from smoking over the past 7 days biochemically confirmed with carbon monoxide and saliva cotinine.|26 weeks after target quit smoking date||||Participants|||Count of Participants
2741948|NCT00938886|Primary|Percent Heavy Drinking Days|Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day|Across the 6 months following smoking quit date||||percentage of days||Standard Deviation|Mean
2741949|NCT00938860|Secondary|Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason|Defined as number of patients with dose reduction or discontinuation of AV therapy due to poor tolerability|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741986|NCT00938639|Secondary|Duration of Solicited Local AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
2741950|NCT00938860|Secondary|Number of Participants for Relapse Rate|Defined as reappearance of detectable Hepatitis C Virus (HCV) RNA at 24 weeks after completion of antiviral treatment when HCV RNA was undetectable at the end of treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741951|NCT00938860|Secondary|Number of Participants of True Non-responder Rate|Defined as failure to achieve at least a 2 log reduction of Hepatitis C virus (HCV) RNA. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741952|NCT00938860|Secondary|Number of Participants for the End of Treatment Response (ETR)|ETR defined as non-detectable HCV RNA at the completion of AV treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741953|NCT00938860|Secondary|Number of Participants of Early Viral Response (EVR)|EVR defined as non-detectable HCV RNA or a ≥2 logs reduction of HCV RNA at 12 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 12|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741954|NCT00938860|Secondary|Number of Participants of Rapid Viral Response (RVR)|RVR defined as non-detectable HCV RNA 4 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 4|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741955|NCT00938860|Secondary|Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite, Participants showing an increase of Ishak Knodell fibrosis score by at least one level (increase of ≥1)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741956|NCT00938860|Secondary|Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components|Efficacy failure (biopsy proven acute rejection (BPAR), graft loss, or death|Week 80|Intent-to-Treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Number of events|||Number
2741957|NCT00938860|Primary|Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus|The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
2741958|NCT00938782|Primary|Time to Extubation|The exact time from end of last anesthetic drug to time of tracheal extubation.|Measured from time of end anesthesia to time of tracheal extubation.|All patients enrolled in both groups.|||minutes||Standard Deviation|Mean
2741959|NCT00938717|Secondary|12-Week Percent of Abdominal Pain-free Days|"Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst.~Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Percent of Pain-free Days||Standard Deviation|Mean
2741960|NCT00938717|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|A patient is considered to be an AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2741961|NCT00938717|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2741962|NCT00938717|Secondary|12-Week Change in Bloating|"Bloating was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
2741963|NCT00938717|Secondary|12-Week Change in Abdominal Discomfort|"Abdominal discomfort was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
2741964|NCT00938717|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
2741965|NCT00938717|Secondary|12-Week Change in Severity of Straining|"Straining is measured on a 5-point scale where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
2741966|NCT00938717|Secondary|12-Week Change in Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
2741967|NCT00938717|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per Week||Standard Error|Least Squares Mean
2741968|NCT00938717|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
2741969|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks|"A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2741970|NCT00938717|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.~The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2741971|NCT00938717|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2741972|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2741973|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Nasal) at Week 2|Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
2741974|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Temporal) at Week 2|Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
2741975|NCT00938704|Secondary|Change From Baseline in Corneal Staining at Week 2|Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
2741976|NCT00938704|Secondary|Change From Baseline in Tear Breakup Time (TBUT) at Week 2|Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Seconds||Standard Deviation|Mean
2741977|NCT00938704|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2|Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
2741978|NCT00938639|Secondary|Frequency and Intensity of Unsolicited AEs|"Unsolicited AEs included AEs other than those specifically sought for.~The grading definitions were:~Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.~Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.~Severe (Grade 3): Incapacitating, with inability to work or do usual activities."|From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741979|NCT00938639|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741980|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
2741981|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741982|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
2741983|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2770129|NCT00736099|Secondary|Number of Patients With HbA1c<7.0% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||participants|||Number
2741987|NCT00938639|Secondary|Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
2741988|NCT00938639|Secondary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination||180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741989|NCT00938639|Secondary|GMFI in the HI Antibody Titre 180 Days After the Second Vaccination|The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.|21 days and 180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2741990|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.~Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination)."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741991|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.~Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the first (or second, as appropriate) study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741992|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741993|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741994|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2741995|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2741996|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741997|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741998|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2741999|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2742000|NCT00938639|Primary|GMFI in the HI and MN Antibody Titer After the Second Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2742001|NCT00938639|Primary|Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2742002|NCT00938639|Primary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2742003|NCT00938639|Primary|Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
2742004|NCT00938548|Secondary|Pain Scores (VNRS) at 1 Week and 1 Month After Operation|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1 week, 1 month||||Units on a scale||Standard Deviation|Mean
2742005|NCT00938548|Primary|Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.|1, 6, 24, 48 hour||||participants|||Number
2742006|NCT00938548|Primary|Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1, 6, 24, 48 hour||||Units on a scale||Full Range|Median
2742007|NCT00938470|Secondary|Percentage of Participants With Overall Clinical Tumor Response (CR or PR)|Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I). > CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to <1 cm; or >=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2742008|NCT00938470|Secondary|Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event|Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||Participants|||Count of Participants
2742009|NCT00938470|Secondary|Disease-free Survival|Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||months||95% Confidence Interval|Median
2742010|NCT00938470|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the time of death from any cause. Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||months||95% Confidence Interval|Median
2742011|NCT00938470|Primary|Percentage of Participants With Pathologic Complete Response (PCR)|Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2742012|NCT00938457|Secondary|Evaluation of Cause of Death (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.||||||
2742013|NCT00938457|Secondary|Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.||||||
2742014|NCT00938457|Secondary|Refinement of Toxicity and Adverse Events Profile (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.||||||
2742015|NCT00938457|Secondary|Median Time to Progression of Treated Tumors (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.||||||
2742016|NCT00938457|Secondary|Local Control (LC) Cumulative Incidence Rates (Phase II)||3 and 6 months and 1, 2, and 5 years|No patients were accrued to the Phase II portion.||||||
2742017|NCT00938457|Secondary|Radiographic Response Rate (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.||||||
2742018|NCT00938457|Secondary|Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)||Up to 2 years|||||||
2742019|NCT00938457|Secondary|Toxicity and Adverse Events Profile (Phase I)|"Number of patients with a grade >= 3 adverse event.~Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Up to 2 years||||participants|||Number
2742020|NCT00938457|Primary|Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)|LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.|At 1 year|No patients were accrued to the Phase II portion.||||||
2742021|NCT00938457|Primary|Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.||2 months|Not enough patients were accrued to the Phase I portion to determine the MTD.||||||
2742022|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 42|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742038|NCT00938392|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.|||Participants|||Count of Participants
2742023|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 35|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742024|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 28|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742025|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 7|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742026|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 42|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742027|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 35|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742039|NCT00938392|Secondary|Number of Subjects Seroprotected for the 3 Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.|||Participants|||Count of Participants
2742080|NCT00938314|Secondary|NIHSS Change From Baseline at Day 30|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 30|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2742028|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 28|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742029|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 7|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2742030|NCT00938431|Secondary|Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.~The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No Change~Minimally worse~Much worse~Very much worse"|Visit 5 (Day 27/28) or Early Termination|"This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.~For one subject in the age group >=12 years to <=17 years no data is available."|||Participants|||Number
2742031|NCT00938431|Secondary|Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.~The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Visit 5 (Day 27/28) or Early Termination|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.|||Participants|||Number
2742032|NCT00938431|Secondary|Change in Seizure Frequency From Baseline to End of Treatment||From Baseline to End of Treatment (approximately 13 weeks)|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.|||percentage change||Standard Deviation|Mean
2742033|NCT00938431|Primary|Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)||13 weeks|The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.|||participants|||Number
2742034|NCT00938392|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.|||Participants|||Count of Participants
2742035|NCT00938392|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESI)|AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.|||Participants|||Count of Participants
2742036|NCT00938392|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.|||Participants|||Count of Participants
2742037|NCT00938392|Secondary|Duration of Solicited Local and General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.|||Days||Full Range|Median
2742078|NCT00938314|Secondary|Barthel Index at Day 90|The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||Scores on a scale||Standard Deviation|Mean
2742040|NCT00938392|Secondary|Seroconversion Factor for the 3 Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.|||Fold Increase||95% Confidence Interval|Geometric Mean
2742041|NCT00938392|Secondary|Number of Subjects Seroconverted for the 3 Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.|||Participants|||Count of Participants
2742042|NCT00938392|Secondary|Number of Subjects Seropositive Against the 3 Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.|||Participants|||Count of Participants
2742043|NCT00938392|Primary|Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains|Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.|||Titer||95% Confidence Interval|Geometric Mean
2742044|NCT00938366|Secondary|Percentage of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1 year, that were absent before treatment or that worsened relative to pre treatment state. AEs Leading to Death and AEs Leading to Discontinuation were also presented in the outcome measure.|Up to 1 year|Safety analysis set included all the randomized subjects who received treatment with at least one dose of either cladribine or pantoprazole during the study period.|||percentage of subjects|||Number
2742045|NCT00938366|Other Pre-specified|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Cladribine|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||liter||Geometric Coefficient of Variation|Geometric Mean
2742046|NCT00938366|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of Cladribine|Clearance of a drug was a measure of the rate at which cladribine is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2742047|NCT00938366|Secondary|Apparent Terminal Half-life (t1/2) of Cladribine|The apparent terminal half-life was defined as the time required for the plasma concentration of drug cladribine to decrease 50 percent (%) in the final stage of its elimination.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour||Geometric Coefficient of Variation|Geometric Mean
2742048|NCT00938366|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Cladribine|The tmax was defined as time taken by the drug cladribine to reach Cmax.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour||Full Range|Median
2742049|NCT00938366|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Cladribine|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2742050|NCT00938366|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Cladribine|The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2742178|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742051|NCT00938366|Primary|Maximum Plasma Concentration (Cmax) of Cladribine|The maximum or peak plasma concentration observed after the administration of cladribine.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|Pharmacokinetic (PK) analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2742052|NCT00938340|Secondary|Main Effect of Treatment by Timepoint on Triglyceride (TG) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and TG was measured at 0, 30, 60, 120, 240, and 360 min. TG were determined by standard colorimetric and enzymatic procedures with commercially available kits (Alfa Wassermann). Several blood samples (n=4) could not be obtained/measured [walnut skin group at 360 min (n=1), walnut oil group at 120 min (n=2), whole walnut group at 240 min(n=1)].|Change from baseline for each timepoint (30, 60, 120, 240, 360 min)||||mmol/L||Standard Error|Least Squares Mean
2742053|NCT00938340|Secondary|Main Effect of Treatment on the Triglyceride (TG) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and TG was measured at 0, 30, 60, 120, 240, and 360 min. TG were determined by standard colorimetric and enzymatic procedures with commercially available kits (Alfa Wassermann).|AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.|All participants who completed each of the 4 treatment arms|||mmol*min/L||Standard Error|Least Squares Mean
2742054|NCT00938340|Secondary|Main Effect of Treatment on Augmentation Index Standardized to a Heart Rate of 75 Beats/Min (AI_75) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. AI is a measure of vascular stiffness (pulse wave reﬂection) that is calculated from the shape of the pulse wave recorded during baseline. AI can be adjusted to a heart rate of 75 beats/min (AI_75) to correct for the independent effect of heart rate on this measure.No endothelial function test data was available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.|Change from baseline at 240 min|All participants who completed each of the 4 treatment arms|||Percent change||Standard Error|Least Squares Mean
2742055|NCT00938340|Secondary|Main Effect of Treatment on Augmentation Index (AI) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. AI is a measure of vascular stiffness (pulse wave reﬂection) that is calculated from the shape of the pulse wave recorded during baseline. No endothelial function test data was available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.|Change from baseline at 240 min|All participants who completed each of the 4 treatment arms|||Percent change||Standard Error|Least Squares Mean
2742056|NCT00938340|Primary|Main Effect of Treatment by Timepoint on C-reactive Protein (CRP) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and CRP measured at 0, 60, 120, 240, and 360 min. Serum CRP was measured by latex-enhanced immunonephelometry. Several blood samples (n=3) could not be obtained/measured (walnut oil/120 min, whole walnut/240 min, and walnut skin/360 min).|Change from baseline for each timepoint (60, 120, 240, 360 min)||||mg/L||Standard Error|Least Squares Mean
2742057|NCT00938340|Primary|Main Effect of Treatment on the Changes in C-reactive Protein (CRP) Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and CRP measured at 0, 60, 120, 240, and 360 min. Serum CRP was measured by latex-enhanced immunonephelometry.|AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.|All participants who completed each of the 4 treatment arms|||mg*min/L||Standard Error|Least Squares Mean
2742058|NCT00938340|Primary|Main Effect of Treatment by Timepoint on Malondialdehyde (MDA) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the clinic after a 12-h overnight fast. A baseline (0 min) blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and MDA measured at 0, 60, 120, 240, and 360 min. Plasma MDA was measured by an Agilent 1100 HPLC system with ﬂuorometric detection. Several blood samples (n=2) could not be obtained (walnut oil group at 120 min and whole walnut group at 240 min).|Change from baseline for each timepoint (60, 120, 240, 360 min)||||umol/L||Standard Error|Least Squares Mean
2742079|NCT00938314|Secondary|Modified Rankin Scale (mRS) Response <=2 at Day 90|The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response <=2 is defined as the mRS score <=2 at Day 90.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||participants|||Number
2744178|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
2742059|NCT00938340|Primary|Main Effect of Treatment on the Changes in Malondialdehyde (MDA) Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and MDA measured at 0, 60, 120, 240, and 360 min. Plasma MDA was measured by an Agilent 1100 HPLC system with ﬂuorometric detection.|AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.|All participants who completed each of the 4 treatment arms|||umol*min/L||Standard Error|Least Squares Mean
2742060|NCT00938340|Primary|Main Effect of Treatment by Timepoint on Total Thiol Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and total thiols measured at 0, 60, 120, 240, and 360 min. Total thiols in plasma were determined by the following methods: an aliquot of EDTA plasma was mixed with Tris-EDTA buffer, followed by addition of 10 mmol/L 2,2-dithiobisnitrobenzoic acid and methanol. After incubation at room temperature for 15 min and centrifugation, the absorbance of the supernatant was measured at 412 nm. Several blood samples (n=3) could not be obtained/measured (walnut skin group at 360 min, walnut oil group at 120 min, whole walnut group at 240 min).|Change from baseline for each timepoint (60, 120, 240, 360 min)||||mmol/L||Standard Error|Least Squares Mean
2742061|NCT00938340|Secondary|Main Effect of Treatment on Heart Rate (HR) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. No endothelial function test data available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.|Change from baseline at 240 min|All participants who completed each of the 4 treatment arms|||beats/minute||Standard Error|Least Squares Mean
2742062|NCT00938340|Secondary|Main Effect of Treatment on Framingham Reactive Hyperemia Index (fRHI) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. fRHI is an alternative calculation derived from the same raw data (as RHI) and differs in that it uses the period from 90 to 120 s of postocclusion hyperemia, does not incorporate a baseline correction factor, and has a natural log transformation applied to the resulting ratio. No endothelial function test data available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.|Change from baseline at 240 min|All participants who completed each of the 4 treatment arms|||ln(ratio)||Standard Error|Least Squares Mean
2742063|NCT00938340|Primary|Main Effect of Treatment on the Changes in Total Thiol Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and total thiols measured at 0, 60, 120, 240, and 360 min. Total thiols in plasma were determined by the following methods: an aliquot of EDTA plasma was mixed with Tris-EDTA buffer, followed by addition of 10 mmol/L 2,2-dithiobisnitrobenzoic acid and methanol. After incubation at room temperature for 15 min and centrifugation, the absorbance of the supernatant was measured at 412 nm.|AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.|All participants who completed each of the 4 treatment arms|||mmol*min/L||Standard Error|Least Squares Mean
2742064|NCT00938340|Primary|Main Effect of Treatment by Timepoint on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) blood sample was collected. Participants then had 15 min to consume 1 of 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and FRAP was measured at 0, 60, 120, 240, and 360 min. The FRAP assay was used to determine the reducing ability of plasma in a redox-linked colorimetric reaction. Plasma was incubated with the FRAP reagent at room temperature for 1 h and the absorbance at 593 nm was then recorded. Trolox was used as a reference to construct a standard curve to calculate the FRAP value of the samples. The FRAP assay measures lipophilic and hydrophilic antioxidants (total antioxidant capacity), both of which are present in walnuts. Several blood samples (n=3) could not be obtained/measured (walnut skin group at 360 min, walnut oil group at 120 min, whole walnut group at 240 min).|Change from baseline for each timepoint (60, 120, 240, 360 min)||||umol Trolox equivalents (TE)/L||Standard Error|Least Squares Mean
2742065|NCT00938340|Primary|Main Effect of Treatment on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and FRAP was measured at 0, 60, 120, 240, and 360 min. The FRAP assay was used to determine the reducing ability of plasma in a redox-linked colorimetric reaction. Plasma was incubated with the FRAP reagent at room temperature for 1 h and the absorbance at 593 nm was then recorded. Trolox was used as a reference to construct a standard curve to calculate the FRAP value of the samples. The FRAP assay measures lipophilic and hydrophilic antioxidants (total antioxidant capacity), both of which are present in walnuts.|AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.|All participants who completed each of the 4 treatment arms|||umol Trolox equivalents (TE)*min/L||Standard Error|Least Squares Mean
2742066|NCT00938340|Secondary|Main Effect of Treatment on Reactive Hyperemia Index (RHI) Changes in Response to 4 Walnut Treatments|On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. RHI was calculated as the ratio of the average pulse wave amplitude during hyperemia (60 to 120 s of the post occlusion period) to the average pulse wave amplitude during baseline in the occluded hand divided by the same values in the control hand and then multiplied by a baseline correction factor. No endothelial function test data available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.|Change from baseline at 240 min|All participants who completed each of the 4 treatment arms|||ratio||Standard Error|Least Squares Mean
2742067|NCT00938327|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (from Day 0 up to Day 30)|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2742068|NCT00938327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 - Day 30) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2742069|NCT00938327|Secondary|Number of Subjects Reporting Solicited General Symptoms|Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day|During the 8-day (Day 0 - Day 7) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2742070|NCT00938327|Primary|Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)|"Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C.~Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day."|During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2742071|NCT00938314|Secondary|Geriatric Depression Scale at Day 90|The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 - 5 is normal, whereas a score of 6 -15 suggests depression.|Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||scores on a scale||Standard Deviation|Mean
2742072|NCT00938314|Secondary|Trails B Test Change From Baseline at Day 90|The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||seconds||Standard Deviation|Mean
2742073|NCT00938314|Secondary|Trails A Test Change From Baseline at Day 90|The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||seconds||Standard Deviation|Mean
2742074|NCT00938314|Secondary|Line Cancellation Test Change From Baseline at Day 90|The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||scores on a scale||Standard Deviation|Mean
2742075|NCT00938314|Secondary|Boston Naming Test (BNT) Change From Baseline at Day 90|The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||Scores on a scale||Standard Deviation|Mean
2742076|NCT00938314|Secondary|Gait Velocity Test Change From Baseline at Day 90|The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||seconds||Standard Deviation|Mean
2742077|NCT00938314|Secondary|Action Research Arm Test (ARAT) Change From Baseline at Day 90|The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||scores on a scale||Standard Deviation|Mean
2743992|NCT00924560|Secondary|Change From Baseline in Bone-specific Alkaline Phosphatase||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||µg/L||Standard Deviation|Mean
2742081|NCT00938314|Secondary|NIHSS Response >=4 at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response >=4 is defined as a >=4 change from baseline at Day 90.|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||participants|||Number
2742082|NCT00938314|Primary|National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2742083|NCT00938041|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population|||Participants|||Number
2742084|NCT00938041|Primary|Overall Survival|Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not die were censored at the date of their last contact in the study.|||Months||95% Confidence Interval|Median
2742085|NCT00938041|Primary|Time to Treatment Failure|Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.|||Months||95% Confidence Interval|Median
2742086|NCT00938041|Primary|Progression-free Survival|Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study.|||Months||95% Confidence Interval|Median
2742087|NCT00938041|Primary|Duration of Response for All Confirmed Responders (CR + CCR + PR)|For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed.|||Months||95% Confidence Interval|Median
2742088|NCT00938041|Primary|Number of Participants With Complete Response and Confirmed Complete Response|Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population: all participants who received at least one dose of study drug|||Participants|||Number
2742089|NCT00938015|Secondary|Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)|HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2742116|NCT00937937|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Disease assessments for response were performed every 6 weeks, up to 3 years||||percentage of participants||95% Confidence Interval|Mean
2742090|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2742091|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2742092|NCT00938015|Secondary|Number of Joints With Active Arthritis|Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Joints||Standard Deviation|Mean
2742093|NCT00938015|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment||Baseline up to Month 78|Efficacy set included all the participants who signed ICF.|||Percentage of participants|||Number
2742094|NCT00938015|Secondary|Incidence of Adverse Events and Serious Adverse Events Per Participant-Year|Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.|Baseline up to Month 6, 12, 18, 30, 42, 54, 66|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Events per participant year|||Number
2742095|NCT00938015|Secondary|Percentage of Participants With at Least 1 Adverse Event (AE) Per Year|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
2742096|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 5 up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2742097|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 4 up to Year 5|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2742098|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 3 up to Year 4|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2742099|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 2 up to Year 3|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2742117|NCT00937937|Secondary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.|Disease assessment was performed every 6 weeks, up to 3 years.||||months||95% Confidence Interval|Median
2742100|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 1 up to Year 2|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
2742101|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Year 1|Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.|||Percentage of participants|||Number
2742102|NCT00937950|Primary|Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]|The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742103|NCT00937950|Primary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]|The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742104|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type at Month 48|"If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.~The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."|At Month 48|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742105|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type at Month 36|"If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.~The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."|At Month 36|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742106|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type at Month 24|"If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.~The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."|At Month 24|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742115|NCT00937937|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2742107|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type at Month 12|"If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.~The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."|At Month 12|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742108|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results at Month 48|"Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.~CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.~Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations."|At Month 48|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742109|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results at Month 36|"Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.~CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.~Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations."|At Month 36|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742110|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results at Month 24|"Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.~CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.~Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations."|At Month 24|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742111|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results at Month 12|"Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.~CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.~Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations."|At Month 12|The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742112|NCT00937950|Primary|Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest|"Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.~Cervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis."|At Months 12, 24, 36, 48|The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742113|NCT00937950|Primary|Number of Subjects With Colposcopy Referral and Colposcopy Adequacy|Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.|At Months 12, 24, 36, 48|The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742114|NCT00937950|Primary|Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)|"Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.~Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS)."|At Months 12, 24, 36, 48|The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.|||Participants|||Count of Participants
2742120|NCT00937794|Primary|Number of Participants With a Score of at Least 90 on The General Conceptual Ability (GCA) Sub-Scale of The Differential Ability Scale (DAS)|The GCA sub-scale of the DAS, Second Edition (DAS-II) was used to obtain a general measure of cognitive ability.The maximum score is 120, with a higher score indicating greater cognitive ability. A score of 100 is considered an average score.|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.|||participants|||Number
2742121|NCT00937794|Primary|Number of Participants Who Were Screened For The Follow-On Study With an Investigational Agent|"Standardized tests were used to identify patients who were receiving treatment with Elaprase, had cognitive impairment, and were suitable to participate in the follow-on clinical study (HGT-HIT-045). Assessments included:~Cognition: The Differential Ability Scale, Second Edition (DAS-II) or the Bayley Scales of Infant Development, Third Edition (BSID-III);~Adaptive Behavior: The Scale of Independent Behavior-Revised (SIB-R);~Executive Function: The Behavior Rating Inventory of Executive Function-Preschool version (BRIEF-P) for children or the Behavior Rating Inventory of Executive Function (BRIEF) for children less than or ≥6 years of age, respectively;~Motor: The Peabody Developmental Motor Scales-2 (PDMS-2) or the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for children less than or ≥6 years of age, respectively."|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.|||participants|||Number
2742122|NCT00937768|Other Pre-specified|Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms||2 years|Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.||||||
2742123|NCT00937768|Other Pre-specified|Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)||2 years|Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.||||||
2742124|NCT00937768|Other Pre-specified|Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate||2 years|Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.||||||
2742125|NCT00937768|Secondary|Average LASA Overall Quality of Life at Baseline, Months 3 and 6|LASA Overall Quality of Life at Baseline, Months 3 and 6. Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The average and standard deviation of the LASA overall quality of life score are reported below at baseline, months 3 and 6.|Baseline to Months 3 and 6|Patients who completed the LASA and had LASA Overall Quality of Life data at each of the time points are included in each analysis at each time point below.|||score on a scale||Standard Deviation|Mean
2742126|NCT00937768|Secondary|Average Overall FACT-P Total Score at Baseline, Months 3 and 6|The overall FACT-P Total Score at Baseline and months 3 and 6 mean and standard deviations are reported below. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.|Baseline and months 3 and 6|Patients who completed the FACT-P and had FACT-P Total Score data at each of the time points are included in each analysis at each time point below.|||score on a scale||Standard Deviation|Mean
2742127|NCT00937768|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution|Percentage of Participants with Grade 3 or Higher Adverse Events regardless of attribution per NCI CTCAE Version 3|2 years||||percentage of patients|||Number
2742128|NCT00937768|Secondary|Number of Deaths|The number of deaths due to any cause are reported below.|2 years|Study terminated prematurely due to funding issues. Planned analysis for Overall Survival and Prostate Cancer Specific Survival was not performed due to the nature of the closure. Thus, the number of deaths are reported below.|||Participants|||Count of Participants
2742129|NCT00937768|Primary|Biochemical Progression-free Survival Rate|Biochemical progression-free survival (BPFS) was defined as the time from randomization to the time of biochemical progression. If a patient dies without a documentation of biochemical progression, the patient will be considered to have had progressed at the time of death.|2 years|No participants reached the 2 years follow up due to the early termination of the trial.||||||
2742130|NCT00937560|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised).|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Months||95% Confidence Interval|Median
2742131|NCT00937560|Secondary|Overall Survival at 1 Year and 2 Years|Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.|Baseline to Year 2|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Percentage of participants||95% Confidence Interval|Number
2742148|NCT00937521|Secondary|Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.|||Subjects|||Number
2742132|NCT00937560|Secondary|Duration of Response|Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Months||95% Confidence Interval|Median
2742133|NCT00937560|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Percentage of participants||95% Confidence Interval|Number
2742134|NCT00937560|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Months||90% Confidence Interval|Median
2742135|NCT00937547|Primary|HPV Type 51|Number of biopsies positive to HPV 51.|6 months||||biopsies|||Number
2742136|NCT00937547|Primary|HPV Type 58|Number of biopsies positive to HPV 58.|6 months||||biopsies|||Number
2742137|NCT00937547|Primary|HPV Type 45|Number of biopsies positive to HPV 45.|6 months||||biopsies|||Number
2742138|NCT00937547|Primary|HPV Type 33|Number of biopsies positive to HPV 33.|6 months||||biopsies|||Number
2742139|NCT00937547|Primary|HPV Type 31|Number of biopsies positive to HPV 31.|6 months||||biopsies|||Number
2742140|NCT00937547|Primary|HPV Type 18|Number of biopsies positive to HPV 18.|6 months||||biopsies|||Number
2742141|NCT00937547|Primary|HPV Type 16|Number of biopsies positive to HPV 16.|6 months||||biopsies|||Number
2742142|NCT00937547|Primary|HPV Identification|HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer|6 months||||biopsies|||Number
2742143|NCT00937521|Secondary|Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group|To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.|Day 1 through day 7 at 13 months age.|The analysis was performed on the safety population.|||Subjects|||Number
2742144|NCT00937521|Secondary|Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.|Overall study period.|The analysis was performed on the safety population.|||Subjects|||Number
2742145|NCT00937521|Secondary|Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.|||Subjects|||Number
2742146|NCT00937521|Secondary|Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.|||Subjects|||Number
2742147|NCT00937521|Primary|Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination|To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.|Day 1 to day 3 after first vaccination.|The analysis was done on the Safety Population.|||Subjects|||Number
2742177|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742149|NCT00937521|Secondary|Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination|To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).|Day 1 through day 7 after second and third vaccination.|As per safety dataset.|||Subjects|||Number
2742150|NCT00937521|Secondary|Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)|To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).|1 month after booster|The analysis was done on the Per Protocol population.|||Percentage of Subjects||95% Confidence Interval|Number
2742151|NCT00937521|Secondary|Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)|To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.|At 13 months|The analysis was done on the Per Protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2742152|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)|To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.|1 month after fourth vaccination|The analysis was done on the Per Protocol Booster population.|||Percentages of Subjects||95% Confidence Interval|Number
2742153|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)|To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.|12 months (pre-fourth vaccination)|The analysis was done on the Per Protocol Booster population.|||Percentages of Subjects||95% Confidence Interval|Number
2742154|NCT00937521|Secondary|Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).|After the third and the booster vaccination.|As per PP population.|||Ratios||95% Confidence Interval|Geometric Mean
2742155|NCT00937521|Secondary|Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.|At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days|As per PP population.|||Titers||95% Confidence Interval|Geometric Mean
2742156|NCT00937521|Secondary|Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)|"ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:~One month after third vaccination.~One month after booster vaccination (Men B at 12 months of age)."|At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)|Per Protocol Primary and Booster populations.|||Titers||95% Confidence Interval|Geometric Mean
2742157|NCT00937521|Primary|Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination|To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination.|Analysis as per PP population.|||Percentages of Subjects||95% Confidence Interval|Number
2742158|NCT00937495|Secondary|Overall Survival|The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2742159|NCT00937495|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.|Up to 2 years||||months||95% Confidence Interval|Median
2742160|NCT00937495|Primary|Confirmed Tumor Responses|"The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years||||participants|||Number
2742161|NCT00937404|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Dose 1 up to one month following last vaccine dose).|Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.|||Participants|||Count of Participants
2744179|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
2742162|NCT00937404|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-days follow-up period after each dose of the study vaccine.|Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.|||Participants|||Count of Participants
2742163|NCT00937404|Primary|Number of Subjects Reporting Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade of relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 fever = fever above (>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination.|During the 4-day follow-up period after each dose of study vaccine.|Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.|||Participants|||Count of Participants
2742164|NCT00937404|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.|During the 4-day follow-up period after each dose of study vaccine.|Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.|||Participants|||Count of Participants
2742165|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742166|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742167|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2|For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742168|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1|For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742169|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 2|For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)|||Participants|||Number
2742170|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 1|For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)|||Participants|||Number
2742171|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 2|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742172|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 1|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742173|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742174|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742175|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742176|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2744121|NCT00923845|Secondary|Immune Suppression|Immune suppression is defined by the frequency of elimination of a pre-transplant T cell cytokine value.|Cytokine analysis at baseline and within 24 hours of completion of the pentostatin/cyclophosphamide regimen||||% of undetectable cytokine measurements|||Number
2742179|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742180|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742181|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742182|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742183|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 2|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742184|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 1|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
2742185|NCT00937391|Primary|PK Analysis - t 1/2|t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity|Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||hour||Full Range|Median
2742186|NCT00937391|Primary|PK Analysis - Area Under the Drug Concentration-time Curve (AUC)|AUC = Area under the drug concentration-time curve from administration to infinity|Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||µmol•hour/Liter||Full Range|Median
2742187|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)|Vss/BW = volume of distribution at steady state normalized by body weight|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters/kg||Full Range|Median
2742188|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss)|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters||Full Range|Median
2742189|NCT00937391|Primary|PK Analysis - Total Clearance (CL)/Body Weight (BW)|CL/BW = total clearance normalized by BW|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters/hour/kg||Full Range|Median
2742190|NCT00937391|Primary|PK Analysis - Total Clearance (CL)|Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters/hour||Full Range|Median
2742204|NCT00937326|Secondary|Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28|The assessment of PPG and PPI was performed on Day 28 at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast).|Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2770983|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2742191|NCT00937391|Primary|Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers|For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.|Within 5 minutes after injection|Primary Analysis Set (the first 5 PPS participants in each age group)|||Participants|||Number
2742192|NCT00937391|Primary|Dose Determined by Blinded Readers to be Superior for Diagnosis|Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters|Within 5 minutes after injection|Primary analysis set (the first 5 PPS participants in each age group)|||Participants|||Number
2742193|NCT00937391|Primary|Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)|"A clinical judgment by the open-label Clinical Investigators (CIs) as to whether (yes) or not (no) the CI could make a diagnosis from the image."|Within 5 minutes after injection|The first 3 participants of Stage 1 received 2 IV injections of 0.05 mmol/kg body weight (BW), images were obtained after each injection and an assessment made by the CIs as to diagnostic adequacy.|||Participants|||Number
2742194|NCT00937326|Secondary|Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28|HOMA-percentage cell beta function was derived from FPG and FPI as: 20*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as assessment done on Day 1. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of beta cell function||Standard Deviation|Mean
2742195|NCT00937326|Secondary|Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28|HOMA-percentage cell beta function was derived from FPG and FPI as: 20*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.|Day 1 and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of beta cell function||Standard Deviation|Mean
2742196|NCT00937326|Secondary|Change From Baseline in HOMA-IR at Day 28|HOMA-IR was derived from FPG and FPI as: FPI (mU/mL)*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mU*mmol per liter^2||Standard Deviation|Mean
2742197|NCT00937326|Secondary|Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28|HOMA-IR was derived from FPG and FPI as: FPI (micro units [mU]/mL)*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.|Day 1 and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mU*mmol per liter^2||Standard Deviation|Mean
2742198|NCT00937326|Secondary|Change From Baseline in Fructosamine Levels at Day 28|Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population.|||mmol per liter||Standard Deviation|Mean
2742199|NCT00937326|Secondary|Mean Fructosamine Levels at Day 1 and Day 28|Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28.|Day 1 and Day 28|ITT Population.|||mmol/L||Standard Deviation|Mean
2742200|NCT00937326|Secondary|AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28|The assessment of PPG and PPI was performed at 30 minutes, 60 minnutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. AUC with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times) for PPG and PPI.|Day 1 (30 minutes, 60 minutes and 2 hour) and Day 28 (30 minutes, 60 minutes and 2 hour)|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol*hour per liter||Standard Deviation|Mean
2742201|NCT00937326|Secondary|Change From Baseline in HbA1c Levels at Day 28|HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected on Day 1 and Day 28. Baseline value was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
2742202|NCT00937326|Secondary|Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28|The sample for HbA1c assessment was collected on Day 28. HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months.|Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
2742203|NCT00937326|Secondary|Change From Baseline in PPG and PPI Levels at Day 28|The assessment of PPG and PPI was performed at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. Baseline for PPG was defined as the assessment value of FPG done on Day 1 and Baseline for PPI was defined as the assessment value of FPI done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (30 min, 60 min and 2 h at Day 28) values.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2742205|NCT00937326|Secondary|Change From Baseline in FPI Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2742206|NCT00937326|Secondary|Mean Fasting Plasma Insulin (FPI) Levels Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.|Up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2742207|NCT00937326|Secondary|Change From Baseline in FPG Levels Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2742208|NCT00937326|Secondary|Mean Fasting Plasma Glucose (FPG) Levels Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.|Up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2742209|NCT00937326|Primary|Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||mL/kg||Standard Deviation|Mean
2742210|NCT00937326|Primary|Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||Liter/hour||Standard Deviation|Mean
2742211|NCT00937326|Primary|Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. The t1/2 was obtained as the ratio of ln2/λz, where λz is the terminal phase rate constant estimated by linear regression analysis of the concentration-time data.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
2742212|NCT00937326|Primary|Time to Cmax (Tmax) at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
2742221|NCT00937326|Primary|Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time|Assessment for ALT, AST, ALP, creatinine phosphokinase and LDH were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||International units per liter||Standard Deviation|Mean
2744180|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
2742213|NCT00937326|Primary|Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. On Day 1, Day 2 and Day 29, participants fasted for at least 10 hour overnight. The post-dose sample was collected within 2 minutes of the scheduled time. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Standard Deviation|Mean
2742214|NCT00937326|Primary|Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28|The pre-dose blood samples were collected within one hour prior to study medication administration. The post-dose blood samples were collected within 2 minutes of the scheduled time. AUC values reported in the analysis of AUC 0-infinity of Day 28 versus Day 1 included AUC 0-infinity on Day 1 and AUC 0-τ on Day 28. Participants fasted for at least 10 hour overnight on Day 1, 2 and 29. The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC0-infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log10 transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28)|Pharmacokinetic (PK) Population defined as all participants who received SRT2104, had sufficient blood samples taken to obtain a plasma concentration time profile and who did not violate the protocol in such a way that it could influence the statistical analysis. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)*hour/milliliter (mL)||Standard Deviation|Mean
2742215|NCT00937326|Primary|Change From Baseline in Urinalysis Parameter of pH Over Time|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessment was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Points on scale||Standard Deviation|Mean
2742216|NCT00937326|Primary|Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2742217|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time|Assessment for albumin and total protein were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Gram per liter||Standard Deviation|Mean
2742218|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Lipid Profile Over Time|Assessment for lipid profile was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. The parameters included high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and triglycerides. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
2742219|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time|Assessment for direct bilirubin, indirect bilirubin, serum creatinine, total bilirubin and uric acid were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Micromole per liter||Standard Deviation|Mean
2742220|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time|Assessment for bicarbonate, BUN, calcium, chloride, magnesium, phosphate, potassium and sodium were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Micromole (mmol) per liter||Standard Deviation|Mean
2770984|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2742222|NCT00937326|Primary|Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time|Assessment for international normalized ratio was performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.|Baseline (Day 1), Day 28 and Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2742223|NCT00937326|Primary|Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time|Assessment for aPTT and PT were performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.|Baseline (Day 1), Day 28 and Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Seconds||Standard Deviation|Mean
2742224|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time|Assessment for mean corpuscular volume was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
2742225|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time|Assessment for mean corpuscular hemoglobin concentration was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Gram hemoglobin per liter||Standard Deviation|Mean
2742226|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time|Assessment for mean corpuscular hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Picogram per cell||Standard Deviation|Mean
2742227|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Hemoglobin Over Time|Assessment for hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Gram per liter||Standard Deviation|Mean
2742228|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Hematocrit Over Time|Assessment for hematocrit was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2742229|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time|Assessment for RBC count was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
2742230|NCT00937326|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time|Assessment for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and white blood cell (WBC) count were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Giga cells per liter||Standard Deviation|Mean
2742231|NCT00937326|Primary|Change From Baseline in Electrocardiogram (ECG) Values Over Time|12-lead ECG was obtained in the rested state. Participants lied in supine position with ECG leads on for at least 5 minutes prior to ECG recording. The ECG was performed at Day 1 (pre-dose and post-dose), Day 8, Day 15, Day 22, Day 28 (pre-dose and pre-dose) and Day 35, and included the assessment of PR interval, QRS interval, QT interval and QTc interval. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1 [post-dose], Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Millisecond||Standard Deviation|Mean
2742240|NCT00937235|Secondary|TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)|Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit|Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit||||Number of Cigarettes Smoked||Standard Deviation|Mean
2742241|NCT00937235|Secondary|Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up|"Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.~Higher scores indicate higher/worse levels of depression."|3-month follow-up||||Scores on a scale||Standard Deviation|Mean
2742232|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Temperature Over Time|Vital sign assessment of temperature was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Degree celcius||Standard Deviation|Mean
2742233|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time|Vital sign assessment of RR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2742234|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time|Vital sign assessment of HR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
2742235|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time|Vital sign assessment of SBP and DBP was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2742236|NCT00937326|Primary|Mean Change From Baseline in Weight Over Time|Participant's body weight was assessed in the beginning of the study (at Day 1) and at the end of the study (Day 28 and Day 35). The clinical staff was instructed to use calibrated scales for weight measurement. The same scale was used at the clinical site for all participants at each specified time point during the study. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Kilogram (kg)||Standard Deviation|Mean
2742237|NCT00937326|Primary|Number of Participants With AE by Intensity of Mild, Moderate and Severe|Intensity for each AE was categorized as mild, moderate and severe. Mild was defined as awareness of sign or symptom, but easily tolerated; moderate was defined as discomfort enough to cause interference with normal daily activities; severe was defined as inability to perform normal daily activities.|Up to Follow-up (58 days)|Safety Analysis Set Population.|||Participants|||Count of Participants
2742238|NCT00937326|Primary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. AE's were classified as related to the study medication, based on the investigator's judgment.|Up to Follow-up (58 days)|Safety Analysis Set (SAF) Population was defined as all participants who received at least one dose of any test material during the study.|||Participants|||Count of Participants
2742239|NCT00937235|Secondary|TLFB - Cigarettes Smoked Week Before 3-Month Follow-up|Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit|3-month follow-up||||Number of Cigarettes Smoked||Standard Deviation|Mean
2742305|NCT00936663|Secondary|eGFR|estimated glomerular filtration rate (eGFR) at 1 year|1 year||||mL/min/1.73 m²||Standard Deviation|Mean
2742242|NCT00937235|Secondary|Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment|"Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.~Higher scores indicate higher/worse levels of depression."|Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)||||Scores on a scale||Standard Deviation|Mean
2742243|NCT00937235|Secondary|Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up|"Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.~Higher scores indicate higher/worse levels of PTSD."|3-month follow-up||||scores on a scale||Standard Deviation|Mean
2742244|NCT00937235|Secondary|Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment|"Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.~Higher scores indicate higher/worse levels of PTSD."|Post-treatment, occurring 12 weeks after the start of treatment (week 0)||||Scores on a scale||Standard Deviation|Mean
2742245|NCT00937235|Secondary|Blood Serum Cotinine|Level of cotinine in blood|At end of 3-month follow-up||||ng/mL||Standard Deviation|Mean
2742246|NCT00937235|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence|Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm.|At 3-month follow-up (6-month post-quit day)||||Participants|||Count of Participants
2742247|NCT00937157|Secondary|To Determine the Correlation of MTI and Cumulative Gd Enhancing Lesions Using the 1.5T and 3T Protocols.||day 0, 3, 6, 9 & 12 months|||||||
2742248|NCT00937157|Primary|A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.||0-180 days and 0-360 days|Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.|||Cumulative GAD lesions (number of)||Standard Deviation|Mean
2742249|NCT00937118|Primary|Duodenal-related Complications|Duodenal-related complications including leak, obstruction, and abscess|20 years|Patients with duodenal related complications|||percentage of subjects|||Number
2742250|NCT00937105|Secondary|Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins|Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids|up to 1 year|All participants in which valid lids bioburden data was available|||participants|||Number
2742251|NCT00937105|Secondary|Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins|Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids|up to 1 year|All participants in which valid lens bioburden data was available|||participants|||Number
2742252|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases|Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora|up to 1 year|All participants in which valid lens case bioburden data was available|||participants|||Number
2742253|NCT00937105|Secondary|Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.|Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones|up to 1 year|Number of participants with valid presumed solution induced corneal staining data in each group|||participants|||Number
2742254|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lenses|Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses|up to 1 year|All participants in which valid lens bioburden data was available|||participants|||Number
2742255|NCT00937105|Primary|Number of Participants Developing a Corneal Inflammatory Event (CIE)|Raw number of participants in each solution arm developing CIE over 12 month follow-up period|up to 1 year|This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.|||participants|||Number
2742256|NCT00937040|Secondary|Epworth Sleepiness Scale (ESS)|The Epworth Sleepiness Scale (ESS) is an 8-item self-rated questionnaire designed to assess the overall level of daytime sleepiness. Each item describes normal daily situations (i.e., watching TV, lying down in the afternoon, sitting inactive in a public place) and subjects rate the likelihood of dozing off or falling asleep in each situation. Responses use a 4-point rating scale (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing). Item scores are summed to produce a total score (range of 0-24) with lower score suggesting more alertness.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742257|NCT00937040|Secondary|Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI discriminates between good and poor sleepers. The self-administered scale contains 15 multiple-choice items concerning frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration over the past month. The PSQI generates 7 scores corresponding to the different sleep domains. Each component score ranges from 0 to 3. Total sleep index is calculated by adding up the 7 component scores (low=0, high=21, the lower the score, the better in sleep quality).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742306|NCT00936663|Secondary|HbA1c|HbA1c at 1 year|1 year||||percentage of glycated haemoglobin||Standard Deviation|Mean
2742258|NCT00937040|Secondary|Adult ADHD Self-Report Scale (ASRS) Over Time|The Adult ADHD Self-Report Scale (ASRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the subject's own rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742259|NCT00937040|Secondary|Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires the subject's DO to answer 4 questions related to how much the subject's ADHD symptoms have changed since starting the medication, how much benefit was received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. Responses vary from extremely satisfied, very satisfied, satisfied, neutral, mildly dissatisfied, dissatisfied, very dissatisfied, or extremely dissatisfied.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question|||Participants|||Number
2742260|NCT00937040|Secondary|Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale|The Dyadic Adjustment Scale (DAS) completed by DOs who were spouses or significant others assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. Possible responses include 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question DAS subset, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742261|NCT00937040|Secondary|Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A, as completed by the DO, is a measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of an adult informant familiar with the subject's functioning. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in nine non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC) are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742262|NCT00937040|Secondary|Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV|The ADHD Rating Scale-IV (Significant Other) is an 18-item list of core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms. Each item is rated on a four point Likert type scale (0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often). The subject's designated observer will complete this scale, with baseline assessment based on the subject's usual functioning when not on medication. The total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set and non-missing values at each timepoint. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742263|NCT00937040|Secondary|Clinical Global Impression - Severity of Illness Subscale (CGI-S)|"The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of the ADHD symptoms in relation to the clinician's total experience with ADHD subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question Considering your total clinical experience with this particular population, how ill is the subject at this time?."|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742264|NCT00937040|Secondary|Responder Rate Using AISRS|AISRS responder rate is defined as the percentage of subjects with AISRS < 18 at endpoint.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set|||Percent of participants|||Number
2742265|NCT00937040|Secondary|Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires subjects to answer 4 questions related to how much their ADHD symptoms have changed since starting the medication, how much benefit they received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. The responses for this question vary with range of satisfaction (e.g. extremely satisfied, very satisfied, satisfied, neutral, dissatisfied, very dissatisfied, or extremely dissatisfied).|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question|||Participants|||Number
2742307|NCT00936663|Primary|Fasting Blood Glucose|Fasting blood glucose levels at 1 year|1 year||||mg/dl||Standard Deviation|Mean
2742363|NCT00936065|Secondary|Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data|||units on a scale||Standard Deviation|Mean
2742266|NCT00937040|Secondary|Subject's Rating of Dyadic Satisfaction Subscale (DSS)|The Dyadic Adjustment Scale (DAS) assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. The response format varies across the entire scale and includes 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question subset of the DAS, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742267|NCT00937040|Secondary|Subject's Rating of Endicott Work Productivity Scale (EWPS)|The EWPS provides a measure of the subject's report of their overall productivity (low=0, high=100, a higher score indicates worsening work productivity and efficiency). There are 25 items (questions 15-39) on the scale that describe types of behaviors/ subjective feelings that are highly likely to reduce work productivity/efficiency. These 25 items are rated on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, to 4=almost always) indicating how often the behavior, feeling or attitude has been manifested in the past week. The total score is the sum of the 25 items.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742268|NCT00937040|Secondary|Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A)|The AIM-A is a subject-reported measure (low=0, high=100, a higher score is more favorable) to assess the overall impact and role that ADHD may have in the conduct of tasks that are expected of adults. The AIM-A is comprised of four global quality of life items, five economic impact items, and five multi-item scales that describe important concepts. Items include: Living with ADHD; General Well-Being; Work, Home and School Performance and Daily Functioning; Relationships; and Communication; and Impact of Symptoms (emotional, degree of daily interference).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742269|NCT00937040|Secondary|Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A is a self-reported measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of the subject's own functioning in the everyday environment. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in 9 non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and GEC are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
2742270|NCT00937040|Secondary|Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)|The Symbol Digit Modalities Test (SDMT) is a computerized variant of the Wechsler Digit Symbol Substitution Test (DSST), but the position of symbols and digits is reversed. Scoring is the number of correct responses generated in 2 minutes. Processing Speed Domain = SDMT correct responses - SDMT errors. Higher scores indicate better functioning (i.e. information processing).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||acccurate responses per minute||Standard Deviation|Mean
2742271|NCT00937040|Secondary|Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The SAT is a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The scores generated by the SAT are: correct matches, errors, and response time. The testing score is a measure of cognitive flexibility. Cognitive Flexibility Domain Score = SAT Correct Responses - SAT Errors - Stroop Commission Errors. Higher scores indicate better accuracy.|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||correct responses||Standard Deviation|Mean
2742272|NCT00937040|Secondary|Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The Shifting Attention Test (SAT) a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The Continuous Performance Test (CPT) is a computerized measure of vigilance or sustained attention/attention over time. Vigilance Domain (Complex Attention) Score = Stroop Commission Errors + SAT Errors + CPT Commission Errors + CPT Omission Errors. Lower scores indicate better functioning (i.e. sustained attention).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||errors||Standard Deviation|Mean
2742273|NCT00937040|Secondary|Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)|"Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The 1st part generates basic reaction time to colors. The 2nd part generates complex reaction time score to matching color names and font color. The 3rd part establishes a Stroop reaction time and an error score to unmatched color names/fonts. Reaction Time Domain Score = (Stroop Complex Reaction Time Correct + Stroop Reaction Time Correct)/2. Lower scores indicate better functioning (i.e. reaction time)."|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||milliseconds (msec)||Standard Deviation|Mean
2742274|NCT00937040|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis|The Adult ADHD Investigator Symptom Rating Score (AISRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the investigator's rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The AISRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set was defined as all randomized subjects who have received at least one dose of the study medication and have any post-baseline efficacy data (not including ASRS).|||units on a scale||Standard Deviation|Mean
2742275|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Normal|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.|Baseline and 12 weeks||||mL/min/mL|Participants|Standard Deviation|Mean
2742276|NCT00936975|Primary|Changes in 18F-fluoride Ki - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||mL/min/mL|Participants|Standard Deviation|Mean
2742277|NCT00936975|Primary|Changes in 18F-fluoride Ki - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 Tumor bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||mL/min/mL|Participants|Standard Deviation|Mean
2742278|NCT00936975|Primary|Changes in 18F-fluoride PET SUV - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 normal bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||SUVmax|Participants|Standard Deviation|Mean
2742279|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.|Baseline and 12 weeks||||mL/min/mL|Participants|Standard Deviation|Mean
2742280|NCT00936975|Primary|Changes in 18F-fluoride PET (SUV) - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||SUVmax|Participants|Standard Deviation|Mean
2742281|NCT00936910|Secondary|Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock|Records the number of participants with 2 negative cultures who completed the trial and had (-) test of cure cultures on day 5 and 30|30 days|All children with long term venous access with fungal related central line infections were eligible for enrollment in the trial. No one was excluded because of age, sex, race or ethnicity.|||participants|||Number
2742282|NCT00936910|Secondary|The Development of Fungal-related Complications|Records the number of fungal related adverse complications that occurred|Usually 1-28 days|All children with long term central line access with fungal-related central line infections were eligible for enrollment. No one was excluded due to sex, age, race, or ethnicity|||adverse complications|||Number
2742283|NCT00936910|Secondary|The Number of Days Before the Infected Central Line Culture Becomes Negative|Records the mean number of days required for the cultures to become negative|5 days of antifungal lock treatment|All children with long term venous access with central line fungal related infections were eligible for enrollment in the trial. No one was excluded because of age, sex, or ethinicity|||days||Full Range|Mean
2742284|NCT00936910|Primary|Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed|Records the number of patients with 2 negative fungal cultures after 5 days of combined systemic antifungal and antifungal lock therapy and the CVC was not removed|5 days of antifungal lock treatment|13 children with long term central line venous access with positive central line fungal infections were enrolled in the trial.|||Participants|||Count of Participants
2742285|NCT00936897|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data|||Percentage Change From Baseline||95% Confidence Interval|Mean
2742286|NCT00936897|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to Month 12|All randomized subjects using regression imputation for missing post baseline data|||Percentage Change From Baseline||95% Confidence Interval|Mean
2742287|NCT00936897|Secondary|Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1||Baseline to month 1|Randomized subjects who enrolled in the bone marker substudy|||Percentage Change From Baseline||Inter-Quartile Range|Median
2742288|NCT00936897|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data.|||Percentage Change From Baseline||95% Confidence Interval|Mean
2742338|NCT00936208|Secondary|International Renal Interest Society (IRIS) II Score at Week 24|The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
2744181|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
2742289|NCT00936884|Primary|The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period.|This measurement is the second of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint).|Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period|Although 25 patients in the MNTX group and 24 in the placebo group received study drug, 24 and 23 patients, respectively, had ≥ 1 post baseline diary assessment and were analyzed for efficacy.|||percentage of participants|||Number
2742290|NCT00936884|Secondary|Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration.|This endpoint measures the percentage of injections resulting in RFBMs within 4 hours after test article administration during the double-blind period. The percentage of injections resulting in RFBMs is calculated for each patient and then data are expressed as the mean (± standard deviation) percentage for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint).|Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period|Although 25 patients in the MNTX group and 24 in the placebo group received study drug, 24 and 23 patients, respectively, had ≥ 1 post baseline diary assessment and were analyzed for efficacy.|||percentage of injections||Standard Deviation|Mean
2742291|NCT00936884|Primary|The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection.|There were 2 co-primary endpoints for this study. This measurement is the first of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups. To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction). Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only. Therefore, no efficacy results are presented for the open-label period.|Up to 4 hours after the first injection|Although 25 patients in the MNTX group and 24 in the placebo group received study drug, 24 and 23 patients, respectively, had ≥ 1 post baseline diary assessment and were analyzed for efficacy.|||percentage of participants|||Number
2742292|NCT00936741|Secondary|The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity|"The mean Investigator's rating of the change in subject's signs and symptoms of Cushing's syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician's Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.~The instruction was Rate the change in the subject's signs and symptoms of Cushing's from Baseline (1 = much better to 9 = much worse)."|Up to three years.||||units on a scale||Standard Deviation|Mean
2742293|NCT00936741|Primary|Number of Participants With Adverse Events|Subjects who received at least one dose of mifepristone were included in the safety analysis.|Up to three years.|Subjects who received one dose of study drug were included in the safety and ITT analyses.|||participants|||Number
2742294|NCT00936715|Primary|Number of Participants Who Had Access to, and Received the Intervention|This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.|Up to 240 weeks|Participants who were enrolled into the study and received study drug.|||Participants|||Count of Participants
2742295|NCT00936702|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.|Up to 3 years|All participant who has been removed from treatment due to progression, adverse events, or refusal.|||months||95% Confidence Interval|Median
2742296|NCT00936702|Secondary|Duration of Response|Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.|Up to 3 years|All eligible participants who have achieved an objective response at which the participant's objective status is first noted to be either CR or PR.|||months||95% Confidence Interval|Median
2742297|NCT00936702|Secondary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from registration to the disease progression or death (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).|||months||95% Confidence Interval|Median
2742298|NCT00936702|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.|Time from registration to death or last follow-up (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).|||months||95% Confidence Interval|Median
2742299|NCT00936702|Primary|Percentage of Participants With Confirmed Tumor Responses|"Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;"|First 6 Cycles of treatment (an average of 6 months)|All participants except one who was deemed ineligible (treated prior to registration).|||percentage of participants||95% Confidence Interval|Number
2742300|NCT00936663|Other Pre-specified|AUC for C Peptide|Area Under the Curve for C peptide after OGTT|1 year||||ng*hr/ml||Standard Deviation|Mean
2742301|NCT00936663|Other Pre-specified|AUC for Proinsulin|Area Under the Curve for Proinsulin after OGTT|1 year||||pmol*hr/L||Standard Error|Mean
2742302|NCT00936663|Other Pre-specified|AUC for Insulin|Area Under the Curve for insulin after OGTT|1 year||||mciu*hr/ml||Standard Deviation|Mean
2742303|NCT00936663|Other Pre-specified|AUC for Glucose|Area Under the Curve for glucose after OGTT|1 year||||mg*hr/dl||Standard Deviation|Mean
2742304|NCT00936663|Secondary|Hypoglycemia|Number of episodes of hypoglycemia (blood glucose less than 70 mg/dl)|1 year||||episodes||Standard Deviation|Mean
2742308|NCT00936598|Secondary|Daily Analgesic Medication Consumption (Morphine Equivalency)|Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.|daily from the day of surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.||||||
2742309|NCT00936598|Secondary|Pain Severity Visual Analogue Scale|"Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain as bad as it could be."|each of the days following surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.||||||
2742310|NCT00936598|Primary|Brief Pain Inventory (Short-form)|Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).|at the clinical follow-up appointment approximately 7-10 days after surgery|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.||||||
2742311|NCT00936585|Primary|Immunologic Data|Changes in immunological parameters in blood and lamina propria immune cells|Baseline, 6 weeks|All patients in the study were enrolled; not enough patients were enrolled to get enough data to analyze - THERE IS NO DATA as the samples were not processed because not enough patients were enrolled to make any comparison.||||||
2742312|NCT00936481|Secondary|Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls.||at initial visit||||mm||Standard Deviation|Mean
2742313|NCT00936481|Primary|Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls.||at the initial visit||||IU/ml||Standard Error|Mean
2742314|NCT00936455|Secondary|Functional Outcome (mRS(0-1)) at 12 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 12 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
2742315|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
2742316|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
2742317|NCT00936455|Primary|Functional Outcome (mRS(0-1)) at 6 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 6 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
2742318|NCT00936377|Secondary|ICU Length of Stay||The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks||||days||Inter-Quartile Range|Median
2742319|NCT00936377|Secondary|Duration of Study Drug Administration||The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks||||hours||Inter-Quartile Range|Median
2742320|NCT00936377|Secondary|Plasma Epinephrine Concentrations Across Groups Over Time|Plasma epinephrine concentrations|Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug||||ng/mL||Standard Deviation|Mean
2742321|NCT00936377|Secondary|The Occurrence of Adverse Events.|Occurrence of hypotension or bradycardia while on study drug|Seven days||||participants|||Number
2742339|NCT00936208|Secondary|Change in the Framingham Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
2742340|NCT00936208|Secondary|Framingham Score at Week 24|The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
2742322|NCT00936377|Secondary|The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores|Proportion of clinical institute withdrawal assessment (CIWA) Scores listed as severe or moderate 24 Hours after Starting Study Drug. All subjects had at least four CIWA assessments.The CIWA is a ten item scale with each item on the scale scored independently on a 0-7 or 0-4 scale, and the summation of the scores yielding an aggregate value that correlates to the severity of alcohol withdrawal. Ranges of scores are from 0 to 67. Mild alcohol withdrawal is defined with a score less than or equal to 15, moderate with scores of 16 to 20, and severe with any score greater than 20. The ten items evaluated include nausea and vomiting, tremor, sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation.|Every 2-4 hours for 24 hours after starting study drug||||percentage of ciwa assessment|||Number
2742323|NCT00936377|Primary|Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment||24 hours before treatment, 24 hours after treatment on first day of starting study drug||||mg||Inter-Quartile Range|Median
2742324|NCT00936377|Primary|Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment||12 hours before treatment, 12 hours after treatment on first day of starting study drug||||mg||Inter-Quartile Range|Median
2742325|NCT00936377|Primary|Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal||Seven days||||mg||Inter-Quartile Range|Median
2742326|NCT00936351|Primary|Weeks|Vocational rehabilitation staff tracked weekly work hours verified by supervisors and reported the data to study staff during the 24-week interventions. Therefore possible values for total weeks worked range from 1-24.|weeks 1-24||||total number of weeks||Standard Deviation|Mean
2742327|NCT00936351|Primary|Work Behavior Inventory|"The Work Behavior Inventory (WBI: Bryson, et al., 1997) assesses work performance for persons with severe mental illness based on a trained rater's observation of participants at work and an interview with their supervisor. Each of the 35 WBI items are rated as 1- 5 (persistent problem area to frequent area of strength). The total score is the sum of five sub-scales (social skills, cooperativeness, work habits, work quality, and personal presentation). We divided the total score by 35 to produce a mean score that is conducive to interpretation since there are no established cut-offs for interpretation of the total score. Thus the mean scores range from 1-5 and are interpretable based on the anchors for the likert scale ranging from 1 (persistent problem area to 5 (frequent area of strength). Good to excellent interrater reliability was found for raters in this study, with intraclass correlations of .79-.98."|week 24||||units on a scale||Standard Deviation|Mean
2742328|NCT00936351|Primary|Hours|total hours worked over the duration of the 24-week treatment|week 1 through week 24 of treatment|3 participants were not included due to early dropout|||total hours worked during treatment||Standard Deviation|Mean
2742329|NCT00936299|Secondary|Change in Number of Days of Cannabis Use in Past 28 Days|The number of days of cannabis use in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cannabis use at baseline was compared to mean number of days of past 28-day cannabis use at end of 16-week trial.|Baseline, 16 Weeks||||days of use||95% Confidence Interval|Mean
2742330|NCT00936299|Primary|Change in Number of Days of Cigarette Smoking in Past 28 Days|The number of days of cigarette smoking in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cigarette smoking at baseline was compared to mean number of days of past 28-day cigarette smoking at end of 16-week trial.|Baseline, 16 Weeks||||days of use||95% Confidence Interval|Mean
2742331|NCT00936299|Primary|Change in ADHD Rating Scale (ADHD-RS) Total Score|DSM-IV ADHD Rating Scale (ADHD-RS) Total Score (clinician administered/adolescent informant). Total scale range 0-54, higher is greater severity.|Baseline, 16 Weeks||||units on a scale||95% Confidence Interval|Mean
2742332|NCT00936221|Secondary|Change in Target Lesion Tumour Size at Week 12||randomization to week 12|Intention to Treat (ITT)|||% change||Full Range|Median
2742333|NCT00936221|Secondary|Objective Response Rate|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)|||Participants|||Number
2742334|NCT00936221|Secondary|Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)|||Days||Full Range|Median
2742335|NCT00936221|Primary|Overall Survival|Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.|From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later|Intention to Treat (ITT)|||Days||Full Range|Median
2742336|NCT00936208|Secondary|Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)|The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24|||participants|||Number
2742337|NCT00936208|Secondary|Change in the IRIS II Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
2742343|NCT00936117|Primary|Maximum Observed Concentration in Plasma (Cmax)|"Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day.~Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 - 5000 ng/ml. There are no established therapeutic ranges for posaconazole."|Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.|Of the 11 females enrolled, one was not evaluable for the outcome thus excluded from analysis.|||ng/ml||Full Range|Median
2742344|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
2742345|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Percentage of participants||95% Confidence Interval|Number
2742346|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement I would like to continue with my current psoriasis treatment. Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742347|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742348|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742349|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742350|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742351|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742352|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742353|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742354|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742355|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742356|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742357|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742358|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742359|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742360|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742361|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
2742362|NCT00936065|Secondary|Change From Baseline in SGA of Itching at Each Visit|Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data|||units on a scale||Standard Deviation|Mean
2742601|NCT00933335|Secondary|Number of Participants Who Died During Their Participation in the Study|Participants who died during the study period were evaluated for the overall survival endpoint.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population|||participants|||Number
2742364|NCT00936065|Secondary|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data|||units on a scale||Standard Deviation|Mean
2742365|NCT00936065|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24|Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of BSA||Standard Deviation|Mean
2742366|NCT00936065|Secondary|Change From Baseline in the PASI Score|Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||units on a scale||Standard Deviation|Mean
2742367|NCT00936065|Secondary|Change From Baseline in the PGA of Psoriasis|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF|||units on a scale||Standard Deviation|Mean
2742368|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
2742369|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
2742370|NCT00936065|Secondary|Time to Achieve a PASI 75 Score|PASI 75 defined as a 75% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
2742371|NCT00936065|Secondary|Time to Achieve a PASI 50 Score|PASI 50 defined as a 50% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
2742372|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
2742373|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
2742374|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Percentage of participants||95% Confidence Interval|Number
2742375|NCT00936065|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
2742396|NCT00935792|Primary|Number of Participants With Dose-Limiting Toxicities|"The maximum tolerated dose is the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Dose-limiting toxicity will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria.~Hematologic: ANC ≤ 0.3 x 109/L or platelet count < 10 x 109/L Other nonhematologic: ≥grade 3 as per NCI Common Terminology Criteria for Adverse Events v3.0 except for fatigue, hyperlipidemia, and hyperglycemia."|1 Month|All phase 1 patients are evaluable|||participants with DLTs|||Number
2742376|NCT00936065|Primary|Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)|||percentage of participants||95% Confidence Interval|Number
2742377|NCT00935883|Secondary|Change in Visual Acuity for Geographic Atrophy Group|Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.|Baseline/ 6 Months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||letters||Standard Deviation|Mean
2742378|NCT00935883|Primary|Decrease in Drusen Volume||6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||mm^3||Standard Deviation|Mean
2742379|NCT00935883|Secondary|Change in Visual Acuity for Drusen Group|Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.|Baseline/ 6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||letters||Standard Deviation|Mean
2742380|NCT00935883|Primary|Growth of Geographic Atrophy||6 months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||millimeters||Standard Deviation|Mean
2742381|NCT00935857|Secondary|Procedural Complications|Number of patients with any procedural complications as assessed 7 days after procedure.|7 days post procedure||||participants|||Number
2742382|NCT00935857|Secondary|Time (Minutes) to Cecum|Time, in minutes, until reaching cecum in each arm.|Day of Procedure||||minutes||Standard Deviation|Mean
2742383|NCT00935857|Primary|Complete Colonoscopy to the Cecum|Number of patients with a complete colonoscopy to the cecum|Day of Procedure|Per Protocol, Terminated at Interim Analysis|||patients|||Number
2742384|NCT00935818|Secondary|Point Prevalence Abstinence at 12 Months|Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days|12 months||||participants|||Number
2742385|NCT00935818|Secondary|Prolonged Abstinence at 12 Months||12 months|intention to treat - all subjects|||participants|||Number
2742386|NCT00935818|Secondary|Point Prevalence Abstinence at 6 Months.|Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.|6 months|Intention to treat - all subjects|||participants|||Number
2742387|NCT00935818|Primary|Point Prevalence Abstinence at 3 Months.|biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.|3 months|intent to treat - all subjects|||participants|||Number
2742388|NCT00935818|Secondary|Weight Gain From Baseline to 3 Months|Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit|3 months|analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence|||kilograms||Standard Deviation|Mean
2742389|NCT00935818|Secondary|Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.||6 months|intention to treat - all subjects|||participants|||Number
2742390|NCT00935818|Primary|Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.|"Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"|3 months|intention-to-treat (all randomized subjects included)|||participants|||Number
2742391|NCT00935792|Secondary|Time to Subsequent Therapy||up to 5 years||||Months||95% Confidence Interval|Median
2742392|NCT00935792|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient's objective status is first noted to be a Complete Response or Partial Response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier|up to 5 years|These are 8 patients with verified complete or partial responses(used in primary outcome measure) as well as 2 non verified partial responses.|||Months||95% Confidence Interval|Median
2742393|NCT00935792|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier|up to 5 years||||Months||95% Confidence Interval|Median
2742394|NCT00935792|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|up to 5 years||||Months||95% Confidence Interval|Median
2742395|NCT00935792|Primary|Test the Safety and Tolerability of the Combination of Everolimus and Alemtuzumab.|The number and severity of all adverse events will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination in this patient group. Below is the number of patients that experienced a grade 3+ Adverse event that was at least possibly related to Treatment.|Up to 12 months past final treatment||||participants|||Number
2742422|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=6.5%|Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.|||percentage of subjects|||Number
2742397|NCT00935792|Primary|Clinical Response (Complete or Partial Remission)|CR requires all of the following for a period of at least 2months:Absence of lymphadenopathy.No hepatomegaly or splenomegaly.Absence of constitutional symptoms.• Neutrophils>1500/ul•Platelets>100,000/ul • Hemoglobin >11.0gm/dl• Peripheral blood lymphocytes <4000/uLBonemarrow. normocellular with<30%of nucleated cells being lymphocytes.PR requires two for 2+months.≥50%decrease in peripheral blood lymphocyte count from the pretreatment baseline value.≥ 50%reduction in the sum of the products of the maximal perpendicular diameters of the largest measured node or nodal masses in the right and left cervical, axillary, and inguinal lymph node regions.≥ 50%reduction in size of liver and/or spleen noting the maximal distance below the respective costal margins of palpable hepatosplenomegaly during rest.Neutrophils>1500/ul or50%improvement over baseline. Platelets>100,000/ul or50%increase over baseline. Hemoglobin>11.0 gm/dl or50%increase over baseline without transfusions|After 2 courses of treatment|All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|||participants|||Number
2742398|NCT00935766|Primary|Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.|"We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega-3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV.~."|Baseline, 3 months||||cm/sec||Standard Deviation|Mean
2742399|NCT00935766|Secondary|Change in hsCRP||baseline, 3 months||||mg/L||Standard Deviation|Mean
2742400|NCT00935766|Secondary|Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)||baseline, 3 months||||ng/mL||Standard Deviation|Mean
2742401|NCT00935701|Secondary|Change in Parenting Stress Index|The Parenting Stress Index (PSI) was designed for parents of children ages 1:6 to 12:5 and identifies stressors in the parent-child relationship. Specifically, the PSI measures child's characteristics on six subscales, which are summed get a total score in the child domain (47 to 235). The PSI also has seven subscales that measure parent characteristics, and are summed to get a total score in the parent domain (54 to 270). The totals from the parent and child domains are summed for a total stress score (101 to 505). Higher scores indicate a higher level of stress. Pre scores were subtracted from post scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2742402|NCT00935701|Secondary|Change in Children's Sleep Habits Questionnaire|The Children's Sleep Habits Questionnaire (CSHQ) assesses sleep problems common in school-age children and is comprised of eight subscales. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. Subscale scores from pre intervention were subtracted from post subscale scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2742403|NCT00935701|Secondary|Change in Conners' Rating Scales|The Conners' Rating Scales Revised (CRS-R) is used to assess attention deficit hyperactivity disorder (ADHD) as well as other related behavioral concerns. The CRS-R is made up of 14 scales. Analysis was done on 6 of these scales: Conners' Global Index Restless-Impulsive, Conners' Global Index Emotional Lability, Conners' Global Index Total, DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive, and DSM-IV Total. Raw scores are converted to T-scores, based on age and gender of the child. A high T-score indicates a greater number and/or frequency of reported concerns. Pre T-scores were subtracted from post T-scores to calculate the change in T-score.|Pre intervention (baseline), post intervention (8 weeks)||||t-scores||Standard Deviation|Mean
2742404|NCT00935701|Primary|Proportions of Children Completing Acupressure and Acupuncture Treatment.||2 months into Phase 1|Participants who transitioned from acupressure to acupuncture were assessed.|||participants|||Number
2742405|NCT00935649|Secondary|Mycology|KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.||||||
2742406|NCT00935649|Primary|Nail Bed Clearing|Change in amount of clear nail over time.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.||||||
2742407|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Median/Range)|For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per minute per visit||Full Range|Median
2742408|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)||Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per minute per visit||Standard Deviation|Mean
2742409|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Median/Range)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per visit||Full Range|Median
2742423|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=7%|Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.|||percentage of subjects|||Number
2742410|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use. Mean and standard deviation of outcome were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n= 60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per visit||Standard Deviation|Mean
2742411|NCT00935584|Primary|Change in Patient Engagement|Change in proportion of time spent on physician-patient communication from pre to post-intervention clinic visit was calculated. Positive change indicates increased time spent on patient communication. Mean and standard deviation of outcomes were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=72 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=125) using all available data.|||percentage of total visit time||Standard Deviation|Mean
2742412|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.~Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Median and range were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.|||units on a scale||Full Range|Median
2742413|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.~Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Mean and standard deviation were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.|||units on a scale||Standard Deviation|Mean
2742414|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.|||events per subject-year||Standard Error|Mean
2742415|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.|||events per subject-year||Standard Error|Mean
2742416|NCT00935532|Secondary|Change in Blood Pressure From Baseline to Endpoint (Week 26)|Change in Blood Pressure from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mmHg||Standard Deviation|Mean
2742417|NCT00935532|Secondary|Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline|Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
2742418|NCT00935532|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)|Change in HDL-C from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mg/dL||Standard Error|Least Squares Mean
2742419|NCT00935532|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26)|Change in Total Cholesterol from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mg/dL||Standard Error|Least Squares Mean
2742420|NCT00935532|Secondary|Change in Body Weight From Baseline to Endpoint (Week 26)|Change in Body Weight from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||kg||Standard Error|Least Squares Mean
2742421|NCT00935532|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)|Change in FSG (centralized measurement) from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mg/dL||Standard Error|Least Squares Mean
2742424|NCT00935532|Primary|Change in HbA1c From Baseline to Endpoint (Week 26)|Change in HbA1c from baseline to endpoint (Week 26).|Baseline, Week 26|Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2742425|NCT00935493|Secondary|Quality of Life (SF-36 MCS)|"Quality of Life (QOL) was assessed using the SF-36 (36-Item Short-Form Health Survey; QualityMetric, Lincoln, RI), MCS subscale. The SF-36 is a self-administered general health-related quality of life scale with 36 items. The MCS subscale has been shown to be responsive in psychoactive drug trials. The score range is 0-100.~Higher scores represent better mental health; therefore, the least squares means listed here represent mean outcome changes from baseline."|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow up|||units on a scale||Standard Error|Least Squares Mean
2742426|NCT00935493|Secondary|Alzheimer's Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC)|The seven-point scale was collapsed into 3 groups and coded as a three-level ordinal scale of global status, representing ordered levels of worse (including minimally, moderately and markedly worse), unchanged, and improved (including minimally, moderately, and markedly improved) global status.|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow-up|||participants|||Number
2742427|NCT00935493|Primary|Mean in the Prefrontal Executive Function Z-score (PEF6_6)|"The primary outcome measure (PEF6_Z) is the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test - B).~The score is composed of six component scales coded as z scores that measures cognitive functioning in which higher scores represent better cognitive functioning; therefore, the least squares means listed here represent mean outcome changes from baseline"|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up.|||Z-score||Standard Error|Least Squares Mean
2742428|NCT00935428|Other Pre-specified|Causes of Horse Related Injuries|Causes of Horse Related Injuries as related by surveyed patients to investigators|2001- 2008||||percentage of participants|||Number
2742429|NCT00935428|Other Pre-specified|Long Term Disability|Those patients who responded to a survey regarding long term disability|2001-2008||||percentage of surveyed participants|||Number
2742430|NCT00935428|Other Pre-specified|Hospital Cost|Total inpatient hospital charges, does not include outpatient costs or any non-hospital charges such as long term therapy, insurance costs, legal cost, etc.|2001-2008||||US Dollars||Full Range|Mean
2742431|NCT00935428|Other Pre-specified|Preventable Head Injuries|Percentage of potentially preventable head injuries among those patients not wearing a helmet at the time of injury|2001-2008||||percentage of participants|||Number
2742432|NCT00935428|Other Pre-specified|Helmet Use|Those patients who were wearing a helmet at the time of injury|2001-2008||||percentage of participants|||Number
2742433|NCT00935428|Primary|Injury Severity Score (ISS)|The Injury Severity Score (ISS) is based upon the Abbreviated Injury Scale (AIS) and is calculated by dividing the body into 6 regions. Each region is scored on a scale of 1 (minor severity/better) to 5 (most severity/worse). ISS total score is calculated by squaring each of the 3 most severely injured body regions, then summing the three squared numbers. Total ISS score can range from 3 to 75.|2008-2011|All patients evaluated at OHSU Hospital with horse-related injuries|||units on a scale||Full Range|Mean
2742434|NCT00935311|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2742435|NCT00935311|Secondary|Time to First Rescue Medication|The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||minutes||95% Confidence Interval|Median
2742436|NCT00935311|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
2742437|NCT00935311|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
2744182|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
2742438|NCT00935272|Secondary|Percentage of Participants With a Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at weeks 12, 16, 20 and 24|For this secondary objective, the pool of participants analyzed was based on 135 from the Intent to Treat population. However the analysis was done with the number of subjects with non-missing data. This number varied for each timepoint.|||Percent of responders||95% Confidence Interval|Number
2742439|NCT00935272|Primary|Percentage of Participants With Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at 8 weeks|Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method|||Percentage of Participants||95% Confidence Interval|Number
2742440|NCT00935259|Secondary|Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo|Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.|2 weeks|Only participants with complete fasting delta 5 desaturase enzyme activity data were included.|||ratio||Standard Deviation|Mean
2742441|NCT00935259|Secondary|Blood Linoleic Acid Levels|Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.|2 weeks|Only participants with complete blood linoleic acid data were included.|||nmol||Standard Deviation|Mean
2742442|NCT00935259|Secondary|Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level|"Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.~The mean reported was an adjusted mean (defined in first outcome measure)."|2 weeks|Only participants with complete PCSK9 data were included.|||nmol||Standard Deviation|Mean
2742443|NCT00935259|Secondary|Fasting Blood Lipidomic Levels After 2 Weeks of Treatment|"Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.~The mean reported was an adjusted mean."|2 weeks|"Only participants with complete blood lipidomic data were included.~For cholesterol ester 22:5n6, n=26 for the simvastatin arm and n=27 for the placebo arm."|||nmol||Standard Deviation|Mean
2742444|NCT00935259|Primary|Arachidonic Acid Level After 2 Weeks of Treatment|"Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.~The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term."|2 weeks|Only participants with complete arachidonic acid data were included.|||nmol||Standard Deviation|Mean
2742445|NCT00935220|Secondary|DPP-4 Inhibition: E_24|Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration|Treated set|||Percent (of inhibition)||Full Range|Median
2742446|NCT00935220|Secondary|Linagliptin: C_max|maximum concentration of linagliptin in plasma on Day 1|24h|Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C_max)|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2742447|NCT00935220|Primary|DPP-4 Inhibition: E_24,ss|Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration under steady state conditions|Treated set|||Percent (of inhibition)||Full Range|Median
2742448|NCT00935220|Secondary|Linagliptin: AUC_0-24|area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose|24 hours|Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC_0-24) for Linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2742449|NCT00935220|Secondary|Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event|Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event|21 days|All treated patients|||Participants|||Number
2742450|NCT00935220|Primary|Linagliptin: C_max,ss|maximum concentration of linagliptin in plasma at steady state|24 hours|Treated set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2742451|NCT00935220|Primary|Linagliptin: AUC_τ,ss|area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval|24 hours|Treated set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2742452|NCT00935220|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|21 days|All treated patients|||Participants|||Number
2742453|NCT00935220|Secondary|Treatment Emergent Adverse Events|Frequency of patients with AEs|21 days|All treated patients|||Participants|||Number
2742470|NCT00934856|Secondary|Cmax of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per summary of product characteristics [SmPC])|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||ng/mL||Standard Deviation|Mean
2742454|NCT00935064|Primary|Expiration/Inspiration Ratio Before and After Treatment|Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.|baseline and 6 weeks||||Ratio||Standard Deviation|Mean
2742455|NCT00935064|Primary|Mean Circular Resultant Before and After Treatment|Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.|baseline and 6 weeks||||MCR is unitless||Standard Deviation|Mean
2742456|NCT00935064|Primary|Serum Renin Level Before and After Treatment|Serum renin level at baseline and follow-up|baseline and 6 weeks||||ug/l/h||Standard Deviation|Mean
2742457|NCT00935064|Primary|Diastolic Blood Pressure Before and After Treatment|Diastolic blood pressure at baseline and follow-up.|baseline and 6 weeks||||mm Hg||Standard Deviation|Mean
2742458|NCT00935064|Primary|Systolic Blood Pressure Before and After Treatment|Systolic blood pressure at baseline and follow-up|baseline and 6 weeks||||mm Hg||Standard Deviation|Mean
2742459|NCT00934947|Secondary|Anxiety Symptoms|Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.|6 weeks after injury was chosen as the main timepoint of interest|The number of patients represents the number of participants responding at 6 weeks after injury.|||units on scale||Standard Deviation|Mean
2742460|NCT00934947|Secondary|Itch Symptoms|Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms.|Week 6 after injury was chosen as the main timepoint of interest|The number of participants who reported itch at the 6 week time point are included in the analysis.|||units on a scale||Standard Deviation|Mean
2742461|NCT00934947|Secondary|Sleep Quality|Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep.|6 weeks after injury timepoint was chosen for this analysis|The number of participants who reported sleep quality at the 6 week time point are included in the analysis.|||units on a scale||Standard Deviation|Mean
2742462|NCT00934947|Primary|Overall Pain Trajectory Slopes|Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.|Study days 5, 7, 10, 13, 17 and 19||||Numeric Rating Scale Score Change/Day||95% Confidence Interval|Least Squares Mean
2742463|NCT00934921|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2742464|NCT00934921|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2742465|NCT00934921|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2742466|NCT00934856|Secondary|Vss of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||liters per square meter (L/m^2)||Standard Deviation|Mean
2742467|NCT00934856|Secondary|CL of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||liters/hour/square meter (L/hr/m^2)||Standard Deviation|Mean
2742468|NCT00934856|Secondary|AUCinf of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||hr*ng/mL||Standard Deviation|Mean
2742469|NCT00934856|Secondary|t1/2 of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||hours (hr)||Standard Deviation|Mean
2742471|NCT00934856|Secondary|AUCinf of Plasma DM1||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||day*ng/mL||Standard Deviation|Mean
2742472|NCT00934856|Secondary|t1/2 of Plasma DM1||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||days||Standard Deviation|Mean
2742473|NCT00934856|Secondary|Cmax of Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)|DM1 is the metabolite of trastuzumab emtansine.|Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2742474|NCT00934856|Secondary|Vss of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mL/kg||Standard Deviation|Mean
2742475|NCT00934856|Secondary|CL of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mL/day/kg||Standard Deviation|Mean
2742476|NCT00934856|Secondary|AUCinf of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||day*mcg/mL||Standard Deviation|Mean
2742477|NCT00934856|Secondary|t1/2 of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||days||Standard Deviation|Mean
2742478|NCT00934856|Secondary|Cmax of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mcg/mL||Standard Deviation|Mean
2742479|NCT00934856|Secondary|Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mL/kg||Standard Deviation|Mean
2742480|NCT00934856|Secondary|Clearance (CL) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||milliliters/day/kilogram (mL/day/kg)||Standard Deviation|Mean
2742481|NCT00934856|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||day*mcg/mL||Standard Deviation|Mean
2742482|NCT00934856|Secondary|Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||days||Standard Deviation|Mean
2742483|NCT00934856|Secondary|Maximum Observed Concentration (Cmax) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hour [Hr] 0), 0.25, 4 hrs post end of infusion (EOI) of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|Pharmacokinetic (PK) analysis population: PK-evaluable participants were defined as participants who received at least one dose of T-DM1 or docetaxel with at least one post-dose concentration data point. Number analyzed = participants evaluable for specified cycle for each arm.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2742506|NCT00934661|Secondary|Distance Walked at Walking Test|Distance walked at walking test. Longer distance walked represent better outcomes|96 hours|"Different amount of observations were different at each visit. Data for Post Surgery Day 4 for the Extended Release Epidural Morphine was not collected."|||Steps||Standard Deviation|Mean
2742484|NCT00934856|Secondary|Number of Participants With Anti-Therapeutic Antibody (ATA) Response to Trastuzumab - MBC and LABC Population|Number of participants with ATA response was reported. Data for this outcome measure was planned to be reported for overall MBC and LABC participants and not by individual treatment arms.|Baseline (Day 1 of Cycle 1), Post baseline (at first follow-up visit [28 days after last dose of study drug][up to approximately 145 weeks])|All participants who received at least one dose of study medication were included. Here, number analyzed=participants evaluable for ATA at specified time-point.|||participants|||Number
2742485|NCT00934856|Secondary|Percentage of Participants With a BOR of CR or PR - LABC Population|BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|LABC population|||percentage of participants||95% Confidence Interval|Number
2742486|NCT00934856|Secondary|Percentage of Participants With Pathological CR (pCR) - LABC Population|The pCR was defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants and lymph nodes after surgery following primary systemic therapy.|Within 6 weeks of post-surgery (up to approximately 3 years)|LABC population: All participants with LABC who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2742487|NCT00934856|Secondary|Duration of Response - MBC Population|Duration of response was calculated for participants with CR or PR based on the RECIST v1.0 criteria. Duration of response was defined as the time interval between the date the CR or PR was first recorded and the date on which PD was first noted or date of death, whichever occurred first. Participants with no documented PD after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively. Median duration of response was estimated using the Kaplan-Meier method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|MBC population|||months||Full Range|Median
2742488|NCT00934856|Secondary|Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population|CBR was defined as percentage of participants experiencing SD of at least 6 months from the start of treatment plus CR or PR according to the RECIST v1.0 criteria. For TLs: CR- disappearance of all TLs. PR- at least 30% decrease in the sum of LDs of the TLs, taking as a reference the BL sum of LDs. PD- at least 20% increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. SD- neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For NTLs: CR- disappearance of all NTLs and normalization of tumor marker levels. SD- persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Percentage of participants= number of participants with CR/PR/SD divided by total number of participants, and then multiplied by 100. 95% CI was determined using the Pearson-Clopper method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|MBC population|||percentage of participants||95% Confidence Interval|Number
2742489|NCT00934856|Secondary|Time to Treatment Failure (TTF) - MBC Population|TTF was defined as the time interval between the date of start of treatment and the date of PD, death from any cause, withdrawal from study treatment, or initiation of non-protocol anti-cancer therapy, whichever occurred first. Participants without an event at the time of the analysis were censored at the date of the last follow-up assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline until end of treatment (up to 39.8 months)|MBC population|||months||Full Range|Median
2742490|NCT00934856|Secondary|Percentage of Participants With Treatment Failure - MBC Population|Treatment failure was defined as the discontinuation of treatment for any reason, including the following qualifying events: PD, death from any cause, withdrawal from study treatment, or initiation of nonprotocol anti-cancer therapy. Percentage of participants with treatment failure was calculated as the (number of participants with treatment failure) divided by (total number of participants), and then multiplied by 100.|Baseline until end of treatment (up to 39.8 months)|MBC population|||percentage of participants|||Number
2742491|NCT00934856|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) - MBC Population|BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% confidence interval (Cl) was determined using the Pearson-Clopper method.|Baseline until disease progression or recurrence (up to approximately 3 years)|MBC population|||percentage of participants||95% Confidence Interval|Number
2742492|NCT00934856|Secondary|PFS - MBC Population|PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of PD or death from any cause, whichever occurred first. Response was based on RECIST v1.0. For TLs, PD was at least a 20 % increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For NTLs, PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Median PFS time was calculated using Kaplan-Meier estimates. Data for participants without PD or death was censored at the time of the last response assessment.|Baseline until disease progression or death (up to approximately 3 years)|MBC population|||months||Full Range|Median
2742507|NCT00934661|Secondary|Patient Satisfaction Score|Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.|96 hours|17 participants in the Extended Release Epidural Morphine group and 18 participants in the placebo group provided Verbal satisfaction scores|||units on a scale||Standard Deviation|Mean
2744183|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
2742493|NCT00934856|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population|PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 (v1.0). For target lesions (TLs), PD was at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For non-target lesions (NTLs), PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Data for participants without PD or death was censored at the time of the last response assessment. Percentage of participants with PFS event was calculated as the (number of participants with PFS event [PD or death]) divided by (total number of participants), and then multiplied by 100.|Baseline until disease progression or death (up to approximately 3 years)|MBC population: All participants with MBC who received at least one dose of study medication were included.|||percentage of participants|||Number
2742494|NCT00934856|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) - MBC and LABC Population|An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Baseline up to 28 days after last dose for MBC participants and for LABC participants who could not undergo surgery, and up to 6 weeks post-surgery for LABC participants who underwent surgery (maximum up to approximately 3 years)|All participants who received at least one dose of study medication were included.|||percentage of participants|||Number
2742495|NCT00934856|Primary|Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population|DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.|Cycle 1 (up to 21 days)|MBC and LABC feasibility population: All participants who received at least one dose of study medication and included in the feasibility part of the study.|||participants|||Number
2742496|NCT00934843|Secondary|Total Intake/Output of Fluid|Total amount of all fluids in and out during the first 36 hours postoperatively in mL.|over 36 hours||||mL||Standard Deviation|Mean
2742497|NCT00934843|Secondary|Urine Output|Total urine output in mL over the first 36 hours after cardiac surgery|over 36 hours||||mL||Standard Deviation|Mean
2742498|NCT00934843|Secondary|Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery|Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery|at 36 hours and 30 days||||participants|||Number
2742499|NCT00934843|Secondary|Inotropic Score|The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.|over the first 36 hours after surgery||||Scores on a scale||Standard Deviation|Mean
2742500|NCT00934843|Primary|Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.|The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support.|36 hours||||participants|||Number
2742501|NCT00934791|Primary|Liver Volume at 2 Years After Kidney Transplantation|Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).|2 years|This study was terminated due to inadequate enrollment, no data was collected on the participant.||||||
2742502|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|4 Days Post Surgery||||units on a scale||Standard Deviation|Mean
2742503|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|3 Days Post Surgery||||units on a scale||Standard Deviation|Mean
2742504|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|2 Days Post Surgery||||units on a scale||Standard Deviation|Mean
2742505|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|1 day post surgery|16 participants were analyzed in both the Extended Release Epidural Morphine and the Placebo Group for active pain scores. 17 participants overall were analyzed for the Extended Release Epidural Morphine and 18 participants overall were analyzed for the Placebo Group.|||units on a scale||Standard Deviation|Mean
2742523|NCT00934596|Secondary|pH at 45 Min of CPB|pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups|Intraoperative||||units on a scale||Inter-Quartile Range|Median
2742508|NCT00934661|Secondary|Total Opioid Consumption|Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)|96 hours|Data not collected on Extended Release Epidural Morphine group|||mg||Standard Deviation|Mean
2742509|NCT00934661|Primary|Length of Hospital Stay After Surgery||From surgery day to hospital discharge, up to 4 days||||Days||Standard Deviation|Mean
2742510|NCT00934648|Secondary|Percentage of Participants With Changes in Bone Density|Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.|Screening, Weeks 48 and 104|ITT population|||percentage of participants|||Number
2742511|NCT00934648|Secondary|Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Screening, Day 1, and Weeks 24 and 104|ITT population|||percentage of participants|||Number
2742512|NCT00934648|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Day 1 and Week 24|ITT population|||scores on a scale||Standard Deviation|Mean
2742513|NCT00934648|Primary|Percentage of Participants With an Adverse Event (AE)||Week 104|Safety population: included all participants who have received any part of an infusion of the study medication.|||percentage of participants|||Number
2742514|NCT00934635|Secondary|Assessment of the Ratio of Dopamine D2-receptor Occupancies in Two Different Areas of the Brain|No measures available due to early termination of trial|Analysis of PET scans at Visit 3 (day 3)|||||||
2742515|NCT00934635|Secondary|Plasma Concentrations of Paliperidone and Risperidone|No measures available due to early termination of trial|Measurement of plasma concentration at Visit 3 (day 3)|||||||
2742516|NCT00934635|Primary|Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies||Visit 3 (on day 3)|PET imaging data were not submitted for further analysis. D2-receptor occupancies could not be calculated due to the low number of subjects in the healthy control group.|||percentage|||Number
2742517|NCT00934622|Secondary|Spectacle Independence|Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.|pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery|Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.|||Percentage of Participants|||Number
2742518|NCT00934622|Primary|Visual Acuity|"Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery||||logMAR||Standard Deviation|Mean
2742519|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|6-10 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.|||participants|||Number
2742520|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|3-6 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.|||participants|||Number
2742521|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|0-3 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.|||participants|||Number
2742522|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|During 10 minutes after cardiopulmonary bypass||||Air Microemboli||Standard Deviation|Mean
2742524|NCT00934596|Post-Hoc|Fraction of Morphologically Damaged Red Blood Cells as Assessed by Scanning Electron Microscopy Studies.|Pieces of tubing from the cardiopulmonary circuit were prepared and photographed in a Scanning Electron Microscope. Visual inspection of each photograph by an investigator blinded to which group the photograph belonged to was performed. The proportion of damaged red blood cells over the total number of red blood cells were calculated.|Pieces of tubing collected after weaning from cardiopulmonary bypass|Samples were collected from 5 participants in each Group (total of 10 participants). For each participant 4 pieces of tubing were collected (20 pieces in each Group, total 40 pieces). Samples were photographed. One photograph from each individual was randomly selected and studied by an investigator blinded to Group (total of 10 photographs).|||Fraction of Damaged Red Blood Cells||95% Confidence Interval|Mean
2742525|NCT00934596|Secondary|Oxygenator Gas Flow at 45 Minutes of CPB|The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.|Intraoperative||||L/minute||Inter-Quartile Range|Median
2742526|NCT00934596|Secondary|De-airing Time After Cardiac Ejection|The duration in minutes of the period after cardiac ejection to finished de-airing procedure.|During de-airing procedure||||minutes||Inter-Quartile Range|Median
2742527|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|After cardiac ejection||||Air Microemboli||Standard Deviation|Mean
2742528|NCT00934596|Secondary|De-airing Time Before Cardiac Ejection|Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).|Measured during intraoperative course||||minutes||Inter-Quartile Range|Median
2742529|NCT00934596|Secondary|Total Time Required for De-airing|The total de-airing time as measured in minutes.|After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes||||Minutes||Inter-Quartile Range|Median
2742530|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|Before cardiac ejection||||Air Microemboli||Standard Deviation|Mean
2742531|NCT00934544|Secondary|Duration of Follow-up by Treatment|Number of Participants with duration of Follow up|baseline, 260 weeks (end of study)|"Safety Set~Numbers of Participants Analyzed reflect only those participants who were randomized to either Ruxolitinib or Best Available Therapy and do not count those participants who could have crossed over to Ruxolitinib"|||participants|||Number
2742532|NCT00934544|Secondary|Bone Marrow Histomorphology|"Shift table from baseline to last available postbaseline fibrosis grade by treatment~The grade gives an indication of the activity or amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is assigned a number based on the degree of inflammation, which is usually scored from 0-4 with 0 being no activity and 3 or 4 considered severe activity"|Baseline, once a year|"Full Analysis Set (FAS)~Numbers of Participants Analyzed reflect only those participants who were randomized to either Ruxolitinib or Best Available Therapy and do not count those participants who could have crossed over to Ruxolitinib"|||participants|||Number
2742533|NCT00934544|Secondary|Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis)|"This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used.~Fibrosis grades: 0 Scattered linear reticulin with no intersections corresponding to normal bone marrow ; 1 Loose network of reticulin with many intersections, especially in perivascular areas; 2 Diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; 3 Diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis"|48 weeks|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.|||Percentage of participants|||Number
2742534|NCT00934544|Secondary|Overall Survival (OS)|Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first. OS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints|From randomization until death from any cause|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||Years||95% Confidence Interval|Median
2742535|NCT00934544|Secondary|Leukemia-free Survival (LFS)|Time from randomization and earliest of either (1) date of bone marrow blast count of 20% or greater; (2) date of first peripheral blast count of 20% or greater that was subsequently confirmed to sustain for at least 8 weeks; (3) date of death from any cause|Time from randomization and earliest of either leukemia or death|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||Years||95% Confidence Interval|Median
2742724|NCT00933244|Secondary|Bone Mineral Density|Annualized percent change in bone mineral density at spine, hip, femoral neck, and body|1 Year|Annual changes in bone mineral density were analyzed for subjects who completed the study. 9 subjects (4%) withdrew from the study, all for personal reasons. Thus, number of participants analyzed is 4% less than number of subjects randomized.|||Percent Change in Bone Mineral Density||Inter-Quartile Range|Mean
2742536|NCT00934544|Secondary|Progression-free Survival (PFS)|Median of time progression free survival (95% CI), years|Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||years||95% Confidence Interval|Median
2742537|NCT00934544|Secondary|Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis)|This is defined as the interval between randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume|Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume|Full analysis set (FAS)|||probability of response||95% Confidence Interval|Number
2742538|NCT00934544|Secondary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24|The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.|Baseline, Week 24|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.|||Percentage of Participants|||Number
2742539|NCT00934544|Secondary|Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates)|﻿This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume.|Baseline, up to Year 5|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||probability of response||95% Confidence Interval|Number
2742540|NCT00934544|Secondary|Duration of Maintenance of Spleen Volume Reduction (Median)|DoMSR is defined as the interval between the first spleen volume measurement that is >=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a >25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.|Baseline, up to Year 5|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||years||95% Confidence Interval|Median
2742541|NCT00934544|Primary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48|The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.|Baseline, Week 48|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.|||Percentage of Participants|||Number
2742542|NCT00934440|Secondary|Time to Progression|The time to progression was measured using time from the first day of treatment to the first day of an evaluation of progressive disease or the date of death for any cause.|2 years||||months||Full Range|Mean
2742543|NCT00934440|Primary|Toxicities by Dose Level|Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|3 to 6 months||||adverse events|||Number
2742544|NCT00934375|Primary|Number of Participants With Treatment-Emergent Adverse Events|Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)|Baseline, Week 6, Week 12 and Week 28.||||Participants|||Number
2742545|NCT00934362|Secondary|Spirometry|Percent change (relative) in FEV1 between pre-treatment baseline and following 5 doses of study treatment. Post treatment values obtained 3 and approximately 22 hours after 5th dose were averaged to determine the treatment effect.|after 5 doses|per protocol|||percent change||Standard Deviation|Mean
2742546|NCT00934362|Primary|Change in Mucociliary Clearance|Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. <60 minutes after the last dose of lucinactant or placebo) reported.|1 hour after final treatment (5th dose) minus baseline|Per protocol|||percent clearance||Standard Deviation|Mean
2742547|NCT00934180|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2742548|NCT00934180|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2742549|NCT00934180|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2742602|NCT00933335|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the treatment start date to the first occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with treatment failure were evaluated.|||months||95% Confidence Interval|Median
2742550|NCT00934141|Secondary|Cost of Group|"The goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is Number."|Baseline and 18 months||||USD ($)|||Number
2742551|NCT00934141|Primary|Change in Average Continuation Rate Through the Fourth Treatment Session|"This outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 21 months||||Change in continuation rate||Standard Error|Mean
2742552|NCT00934141|Primary|Change in Annual Number of Patient Admissions|"We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|48 months (2 year baseline period and 2 year post-intervention period)||||Percent change (approx.)||95% Confidence Interval|Mean
2742553|NCT00934141|Primary|Change in Average Waiting Time From First Contact to Treatment|"The average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 15 months||||Change in days||Standard Error|Mean
2742554|NCT00934128|Primary|Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale|Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.|Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)|One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.|||units on a scale||Inter-Quartile Range|Median
2742555|NCT00934128|Primary|Number of Participants Completing Study Intervention|"Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study.~A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was >/= baseline dyspnea level-1, or (2) their dyspnea level was >/= 3/10 after one hour."|Minimally 1 hour, up to 5 hours||||Participants|||Number
2742556|NCT00934102|Primary|Front Surface Lens Deposits|Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.|Period 2, Day 6|Per Protocol. Only the data from participants who completed all study visits were analyzed.|||Units on a Scale|Participants|Standard Deviation|Mean
2742557|NCT00934050|Primary|Treatment Emergent Adverse Events (TEAEs)|Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)|12 months|As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.|||participants|||Number
2742558|NCT00934024|Primary|Change in Post-Resist Craving|Change in Post-resist task craving between Scan 1, pre-medication, and Scan 2, post- medication, as measured on a 0-10 Likert scale. The Within Sessions Rating scale (Range 0-10) measures craving with 0 indicating Not at All and 10 indicating Extremely. Change scores were calculate by subtracting the craving score immediately following the pre-medication scan from the craving score immediately following the post-medication scan.|5 weeks||||units on a scale||Standard Deviation|Mean
2742569|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 12|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2742559|NCT00933933|Secondary|Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations|Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.|||Blood specimens|||Number
2742560|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.|||Blood specimens|||Number
2742561|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.|||Blood specimens|||Number
2742562|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens|Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.|3 months|Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.|||Blood specimens|||Number
2742563|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.|||Blood Specimens|||Number
2742564|NCT00933686|Secondary|Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale|Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Percentage of participants|||Number
2742565|NCT00933686|Secondary|Multidimensional Assessment of Fatigue (MAF) Total Score|Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Units on a scale|||Number
2742566|NCT00933686|Secondary|EuroQol 5-Dimensions (EQ-5D) Total Score|EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Units on a scale||Standard Deviation|Mean
2742567|NCT00933686|Secondary|Visual Analog Scale (VAS) Total Score|Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||mm||Standard Deviation|Mean
2742568|NCT00933686|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score|Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful).|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Units on a scale||Standard Deviation|Mean
2742599|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at 12 months|12 months||||mm||Standard Deviation|Mean
2742600|NCT00933335|Secondary|Time to Death of Participants During Their Participation in the Study|Time to death is defined as the time from the treatment start date to the date of death.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population|||months||95% Confidence Interval|Median
2742570|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 6|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 6|Intention-to-treat (ITT) population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2742571|NCT00933608|Primary|N-acetylaspartate|The change in N-acetylaspartate (NAA) measured with magnetic resonance spectroscopy (MRS) is the primary outcome measure. NAA is a metabolite found predominately in neuronal cells, and its amount indicates tissue well being (the higher the better). In MRS studies NAA (and other metabolites like choline or myoinositol) are presented as a ratio to creatine (Cr) also measured by MRS. The concentration of creatine does not change is used as an internal standard. The ratio NAA/Cr is unitless. In summary, the measurable outcome will be the NAA/Cr ratio change from pre-to post treatment.|baseline (pre-treatment) and 4 months (post-treatment)|This is an intention to treat analysis, based on initial treatment assignment.|||NAA/creatine Ratio||Standard Deviation|Mean
2742572|NCT00933543|Secondary|Proportion of Patients With Dryness (Mild)||at 12 weeks after first treatment|Safety|||participants|||Number
2742573|NCT00933543|Secondary|Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)||at 12 weeks after first treatment|Safety|||participants|||Number
2742574|NCT00933543|Secondary|Proportion of Patients With Severe and Very Severe Scarring at End of Study||week 12||||participants|||Number
2742575|NCT00933543|Secondary|Proportion of Patients With Clear or Almost Clear Scarring at End of Study||week 12||||participants|||Number
2742576|NCT00933543|Secondary|Proportion of Patients With Mild or Moderate Scarring at End of Study||week 12||||participants|||Number
2742577|NCT00933543|Secondary|Proportion of Patients With Severe Hyperpigmentation||at 12 weeks after first treatment|Safety|||participants|||Number
2742578|NCT00933543|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation||at 12 weeks after first treatment|Safety|||participants|||Number
2742579|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after fourth treatment|Safety population|||cm||Full Range|Mean
2742580|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after third treatment|Safety population|||cm||Full Range|Mean
2742581|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after second treatment|Safety population|||cm||Full Range|Mean
2742582|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after first treatment|Safety population|||cm||Full Range|Mean
2742583|NCT00933543|Secondary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||6 weeks after the first treatment|ITT|||Participants|||Number
2742584|NCT00933543|Secondary|Absolute Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
2742585|NCT00933543|Secondary|Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count||6 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
2742586|NCT00933543|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Count||6 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
2742587|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline||12 weeks after first treatment||||participants|||Number
2742588|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count||12 weeks after last treatment|ITT|||participants|||Number
2742589|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||12 weeks after the first treatment|ITT|||Percent change from baseline||Standard Deviation|Mean
2742590|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT|||Percent change from baseline||Standard Deviation|Mean
2742591|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT|||percentage change from baseline||Standard Deviation|Mean
2742592|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||6 weeks after first treatment|ITT|||percentage change from baseline||Standard Deviation|Mean
2742593|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||12 weeks after the first treatment|ITT|||Percent change from baseline||Standard Deviation|Mean
2742594|NCT00933543|Primary|Absolute Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT|||lesions||Standard Deviation|Mean
2742595|NCT00933543|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)||12 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
2742596|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||6 weeks after the first treatment|ITT|||percent change from baseline||Standard Deviation|Mean
2742597|NCT00933543|Primary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||12 weeks after the first treatment|ITT|||percentage of participants||95% Confidence Interval|Number
2742598|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at baseline|Baseline||||mm||Standard Deviation|Mean
2742603|NCT00933335|Secondary|Number of Participants With a Treatment Failure|Treatment failure is defined as the occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742604|NCT00933335|Secondary|Time to Disease Progression or Death|Time to progression is the time from the treatment start date to the first documented disease progression or death. Disease progression: 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with disease progression were evaluated.|||months||95% Confidence Interval|Median
2742605|NCT00933335|Secondary|Number of Participants With Progressive Disease (PD)|PD is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742606|NCT00933335|Secondary|Duration of Response for All Confirmed Responders|Duration of response was defined as the time from the first documented response to the first documented disease progression. Partial Response (PR): 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions. Responders are the participants with CR, or CCR, or PR.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and were classified as responders were evaluated.|||months||95% Confidence Interval|Median
2742607|NCT00933335|Secondary|Number of Participants With Progression of Disease|Progression of disease is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination. All participants without progression of disease were censored.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: participants with confirmed response rates (CR, CCR, or PR) were evaluated.|||participants|||Number
2742608|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Unconfirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants (par.) evaluable for response were those with >= 1 response assessment. 2 of 38 par. who received <3 cycles of fludarabine withdrew from the study and were not evaluable for response. 35 of 38 par. received TST and I 131 TST treatment and were evaluated for response.|||participants|||Number
2742609|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Confirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions. A confirmed response (resp.) (CR/CCR/PR) had to be confirmed by a consecutive resp. (>=28 days later) that was the same/better. Individual confirmed resp. data only counts that resp. confirmed by the same resp.; not all possible combinations are represented.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. 2 participants (par.) who received <3 cycles of fludarabine (fl.) did not receive TST treatment and were not evaluated. Par. evaluable for response were those with >=1 assessment. Three par. were not evaluable for response. None of the responses could be confirmed after fl. treatment; thus, no data are reported for this arm.|||participants|||Number
2742610|NCT00933335|Primary|Number of Participants Receiving the Indicated Type of Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease. Supportive care involved administration of granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), red blood cell (RBC) transfusions, erythropoietin, and platelet transfusions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment and were not evaluated.|||participants|||Number
2742611|NCT00933335|Primary|Number of Participants Who Received Any Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment, and hence were not evaluated.|||participants|||Number
2742725|NCT00933244|Primary|Intestinal Calcium Absorption|Percent of calcium absorbed in the intestinal tract within one day|One Year|4% of subjects withdrew from the study. Additionally the calcium isotope dose was not recorded in 2 subjects and a urine sample was mishandled in a third. Thus, the number of participants analyzed is less than the number randomized into the trial.|||Total Fractional Calcium Absorption||Inter-Quartile Range|Median
2742612|NCT00933335|Primary|Number of Participants With an Anti-infective Administered at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.|||participants|||Number
2742613|NCT00933335|Primary|Number of Participants With Positive Culture Results for Infections at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|The culture results could be positive or negative. The positive culture results indicates that the tested participant have the infection under investigation so therapeutic treatment with anti-infective is required.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses, those who had an infection, and from whom the cultures were obtained were evaluated.|||participants|||Number
2742614|NCT00933335|Primary|Number of Participants With a Culture Obtained for Infection at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.|||participants|||Number
2742615|NCT00933335|Primary|Number of the Indicated Type of Infection Reported by Investigator Based on Laboratory Testing at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated. A single participant could have had more than one infection. The number analyzed in the category titles reflects the number of participants who had any infection.|||number of infections|||Number
2742616|NCT00933335|Primary|Number of Participants With Any Infection at Week 16 Post-Fludarabine Treatment and Week 13 Post-TST Treatment Detected by Laboratory Culture of Participant Sample or Investigator Report|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
2742617|NCT00933335|Primary|Duration of Any Grade 3 or Grade 4 Toxicity for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||days||Full Range|Median
2742618|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Toxicity (AE) for Hematological Parameters (Absolute Neutrophil Count [ANC], Hemoglobin, and Platelets)|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
2742619|NCT00933335|Primary|Nadir Values for Platelet Count|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.|||10^3/microliter||Full Range|Median
2742620|NCT00933335|Primary|Nadir Values for Hemoglobin|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.|||g/dL||Full Range|Median
2742621|NCT00933335|Primary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.|||10^3/mm^3||Full Range|Median
2770985|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2742622|NCT00933335|Primary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: all participants who received the dosimetric dose were evaluated.|||days||Full Range|Median
2742623|NCT00933335|Primary|Number of Participants With Thyroid Medication Use Prior to the Therapeutic Dose|Thyroid medication included any prescribed medication for the treatment of thyroid dysfunction.|Baseline (study entry; Week -16) and Week 2 to Week 3 (prior to the therapeutic dose)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
2742624|NCT00933335|Primary|Number of Participants With Elevated Thyroid-Stimulating Hormone (TSH) Levels at Baseline (Study Entry) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|The number of participants with elevated TSH levels is reported. An elevated TSH level indicates that an insufficient amount of the thyroid hormone is being produced. Insufficient thyroid hormone production is known as hypothyroidism. The normal range of TSH is between 0.2 and 6.1 milliunits per liter (mU/L).|Baseline (Week -16) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|ITT-Exposed Population: baseline TSH levels were determined for 36 participants. Of 35 participants who received the dosimetric and therapeutic doses of TST/I-131 TST, 2 had elevated TSH at baseline, and 33 were assessed for developing elevated TSH.|||participants|||Number
2742625|NCT00933335|Primary|Time to HAMA Positivity From the First TST/I 131 TST Dosimetric Dose for the Participants Achieving HAMA Positivity|Kaplan-Meier estimates of the time to HAMA positivity (days from the first fludarabine dose) was determined for participants who converted to HAMA positivity.|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who received dosimetric and therapeutic doses and those who were converted to HAMA positivity were evaluated.|||days|||Number
2742626|NCT00933335|Primary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Weeks 12 and 25 and at Months 12, 18, and 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit (Weeks 12 and 25; Months 12, 18, and 24)."|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who were evaluable for HAMA (those who did not have a positive HAHA level at Baseline) and those who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
2742627|NCT00933335|Primary|Number of Participants With the Indicated Treatment-related AEs Experienced by at Least 10% of Participants in the Combined Regimen|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742628|NCT00933335|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 AEs|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. mm, millimeters; mm^3, millimeters cubed. Grade 3 and Grade 4 AEs are reported to focus on the most severe AEs.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742629|NCT00933335|Primary|Number of Participants With Any Treatment-related SAE|All of the treatment-related SAEs experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742630|NCT00933335|Primary|Number of Participants With Any Serious Adverse Event (SAE)|An SAE was defined as any event occurring at any dose that results in any of the following outcomes: death, a life threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742631|NCT00933335|Primary|Number of Participants With Any Treatment-related Grade 3 or Grade 4 Adverse Event|All of the treatment-related grade 3 (severe and undesirable) and grade 4 (life-threatening or disabling) adverse events experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742632|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Adverse Event|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742837|NCT00932152|Secondary|To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2742633|NCT00933335|Primary|Number of Participants With Any Treatment-related Adverse Event (TRAE)|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
2742634|NCT00933335|Primary|Number of Participants With Any Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a causal relationship (association) with this treatment. Therefore, an AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not it was considered to be related to the medicinal product. Laboratory abnormalities were recorded as AEs only if they were associated with clinical sequelae and/or required an intervention.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|Intent-to-Treat (ITT)-Exposed Population: all participants who were enrolled into the study and who received at least 1 dose of fludarabine. The data are presented for the subgroup of the ITT-Exposed Population for those participants who received the dosimetric and therapeutic dose of TST/I 131 TST.|||participants|||Number
2742635|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
2742636|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
2742637|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
2742638|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
2742639|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
2742640|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
2742641|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
2742642|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
2742643|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
2742644|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
2742645|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
2742646|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
2742647|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
2742648|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
2742649|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
2742650|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|1 month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
2742651|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
2742652|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
2742653|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
2742666|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742654|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|1 Month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
2742655|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|Baseline|Per ITT Set. Patients are included in the Rutherford Becker Score if the Rutherford Becker Classification was performed prior to the Study procedure.|||percentage of limbs|||Number
2742656|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742657|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742658|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742659|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742660|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742661|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742662|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742663|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742664|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742665|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742667|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742668|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742669|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742670|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742671|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742672|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742673|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742674|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742675|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742676|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742677|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|12 Months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
2742688|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|30 days (±7 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
2742678|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|6 Months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit."|||units on a scale||Standard Deviation|Mean
2742679|NCT00933270|Secondary|Quality of Life Assessed (QoL) by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the SF-12 Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
2742680|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|36 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742681|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|24 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742682|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|12 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742683|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|6 months (±14 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742684|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|36 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
2742685|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|24 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
2742686|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|12 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
2742687|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|6 Months (±14 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
2742689|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation."|36 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
2742690|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation."|24 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
2742691|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation."|12 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
2742692|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation."|1 month (± 7 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
2742693|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.|36 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742694|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.|24 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742695|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.|12 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742696|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.|6 months (± 14 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742708|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|36 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab|||percentage of participants|||Number
2742697|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 Months (±30 days)|Per ITT set. Patients are included if they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
2742698|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
2742699|NCT00933270|Secondary|SFA Patency: PSV Ratio ≥ 2.0|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
2742700|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|36 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742701|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|24 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742702|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742703|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742704|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|12 Months (± 30 Days)|Per ITT set: Patient returned for visit and had ABI measured|||ratio||Standard Deviation|Mean
2742705|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|6 Months (± 14 Days)|Per ITT set: Patient returned for visit and had ABI measured|||ratio||Standard Deviation|Mean
2742706|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|1 month (± 7 Days)|Per ITT set: Patient returned for visit and had ABI measured|||ratio||Standard Deviation|Mean
2742707|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|Baseline|Per ITT set: Baseline ABI measured prior to study procedure|||ratio||Standard Deviation|Mean
2742710|NCT00933270|Secondary|Stent Fracture Rate|"Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.~Stent fracture classification~Type I - a single strut fracture only.~Type II - multiple single nitinol stent fractures that can occur at different sites.~Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.~Type IV - a complete transverse linear type III fracture with stent displacement.~Type V - a spiral dissection of a stent."|12 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab|||percentage of participants|||Number
2742711|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||36 months (± 30 Days)||||percentage of participants||95% Confidence Interval|Number
2742712|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||24 months (± 30 Days)||||percentage of participants||95% Confidence Interval|Number
2742713|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||12 months (± 30 Days)||||percentage of participants||95% Confidence Interval|Number
2742714|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).|36 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742715|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).|24 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742716|NCT00933270|Secondary|Secondary Safety Composite Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).|12 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742717|NCT00933270|Secondary|Device Success|Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.|intraoperative|Per ITT set: Supera implanted. Post-procedure angiogram analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
2742718|NCT00933270|Secondary|Procedural Success|Defined as device success with < 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.|intraoperative|Per ITT set. Supera implanted. Post-procedure angiogram analyzed by core lab Occurrence of death, amputation or TLR during the hospital stay|||percentage of participants||95% Confidence Interval|Number
2742719|NCT00933270|Secondary|Technical (Lesion) Success|Technical (lesion) success, defined as the attainment of <50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.|intraoperative|Per ITT set: Post-procedure angiogram analyzed by core lab|||percentage of treated segments||95% Confidence Interval|Number
2742720|NCT00933270|Primary|Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 months|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742721|NCT00933270|Primary|Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.||30 days|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
2742722|NCT00933244|Other Pre-specified|Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test|We summarized within-arm one-year changes in continuous muscle outcomes using the mean (95% confidence interval).|1 Year|4% of subjects withdrew from the study and muscle tests were not conducted in four additional subjects who sustained injury or reported leg pain during a study visit. Thus the number analyzed is less than the number randomized into the trial.|||seconds||95% Confidence Interval|Mean
2742723|NCT00933244|Other Pre-specified|Bone Turnover|C-telopeptide (pg/mL) was measured at baseline, 30 days, 60 days, 120 days, 365 days in the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am. Data demonstrated outliers and was summarized using the median (25th, 75th interquartile range).|0, 30, 60, 120, 365 days|Bone turnover markers were analyzed in duplicate for the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am.|||pg/mL||Inter-Quartile Range|Median
2770986|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2742726|NCT00933166|Primary|Comfort After Insertion|Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.|||Units on a Scale||Standard Deviation|Mean
2742727|NCT00932893|Secondary|European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2742728|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2742729|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.|Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2742730|NCT00932893|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough|TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.|Baseline up to end of treatment (up to 112 weeks)|Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.|||months||95% Confidence Interval|Median
2742731|NCT00932893|Secondary|Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins|Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)|The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2742732|NCT00932893|Secondary|Number of Participants With Categorical Maximum QTcF for Crizotinib|QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2|ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.|||participants|||Number
2742733|NCT00932893|Secondary|Plasma Concentration of Crizotinib|Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5|"Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here N (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points."|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2742743|NCT00932828|Secondary|Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).|We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT .|After 36 months of OIT dosing|37 subjects considered with ITT analysis including 5 withdrawals|||Participants|||Count of Participants
2742734|NCT00932893|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.|||weeks||Full Range|Median
2742735|NCT00932893|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.|||weeks||95% Confidence Interval|Median
2742736|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 12|Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Week 12|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2742737|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 6|Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.|Week 6|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2742738|NCT00932893|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2742739|NCT00932893|Secondary|Overall Survival Probability at Months 6 and 12|Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.|Month 6, 12|FAS included all participants who were randomized to study treatment.|||percent chance of survival||95% Confidence Interval|Number
2742740|NCT00932893|Secondary|Overall Survival (OS)|OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Randomization until death (up to 4.5 years)|FAS included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2742741|NCT00932893|Primary|Progression-Free Survival (PFS)|PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|Full analysis set (FAS) included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2742742|NCT00932828|Secondary|Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT.|In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose.|After 36 months of OIT dosing followed by 1 month of avoidance|37 subjects considered with ITT analysis including 5 withdrawals|||AEs per person per dose||95% Confidence Interval|Median
2742838|NCT00932152|Secondary|To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2742744|NCT00932828|Primary|Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).|The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.|After 36 months of OIT dosing followed by 1 month of avoidance|37 subjects considered with ITT analysis including 5 withdrawals|||Participants|||Count of Participants
2742745|NCT00932698|Secondary|Overall Response Rate (ORR)|ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions.|Cycle 1 through Cycle 115 (Up to 80.1 months)|Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post baseline disease assessment.|||percentage of participants|||Number
2742746|NCT00932698|Secondary|TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib|TEmax was determined to characterize the whole blood 20S proteasome inhibition parameters.|Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose|No data is reported due to concerns about the third-party laboratory’s performance of the 20S assay that precluded the ability to confirm the accuracy of the data generated. The data was not considered reliable.||||||
2742747|NCT00932698|Secondary|Emax: Maximum Observed Effect for Ixazomib|Emax was determined to characterize the whole blood 20S proteasome inhibition parameters.|Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose|No data is reported due to concerns about the third-party laboratory’s performance of the 20S assay that precluded the ability to confirm the accuracy of the data generated. The data was not considered reliable.||||||
2742748|NCT00932698|Secondary|CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib|CL/F is apparent clearance of the drug from the plasma.|Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose|CL/F was not reported as this PK parameter could not be calculated.||||||
2742749|NCT00932698|Secondary|T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib||Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose|PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hr||Standard Deviation|Mean
2742750|NCT00932698|Secondary|λz: Terminal Disposition Phase Rate Constant for Ixazomib||Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose|PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||1/hr||Standard Deviation|Mean
2742751|NCT00932698|Secondary|AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib||Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose|PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hr*ng/mL||Standard Deviation|Mean
2742752|NCT00932698|Secondary|AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose|PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hr*ng/mL||Standard Deviation|Mean
2742753|NCT00932698|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose|PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hours||Full Range|Median
2742754|NCT00932698|Secondary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose|PK population was defined as all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Standard Deviation|Mean
2742755|NCT00932698|Primary|Recommended Phase 2 Dose (RP2D) of Ixazomib|The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.|Cycle 1 through Cycle 39 (Up to 28.3 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||mg/m^2|||Number
2742767|NCT00932646|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
2742756|NCT00932698|Primary|Maximum Tolerated Dose (MTD) of Ixazomib|MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation.|Cycle 1 (21 days)|DLT-evaluable population was defined as all participants who received all Cycle 1 doses of ixazomib and completed Cycle 1 or who experienced DLT in Cycle 1.|||mg/m^2|||Number
2742757|NCT00932698|Primary|Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs|The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate.|From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2742758|NCT00932698|Primary|Number of Participants With a TEAE of Peripheral Neuropathy|Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.|From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2742759|NCT00932698|Primary|Number of Participants With Clinically Significant Abnormalities Reported as TEAEs|The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis.|From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2742760|NCT00932698|Primary|Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.|From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)|Safety population included all participants who received at least 1 dose of ixazomib.|||Participants|||Count of Participants
2742761|NCT00932659|Secondary|Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias||6 months|all participants included|||participants|||Number
2742762|NCT00932659|Primary|Number of Participants With a Significant Arrhythmia Detected||6 months|All patients enrolled were analyzed in this observational study.|||participants|||Number
2742763|NCT00932646|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks||||participants|||Number
2742764|NCT00932646|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS).|||Liter||Standard Error|Least Squares Mean
2742765|NCT00932646|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742766|NCT00932646|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742801|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||90 days|2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)|||participants|||Number
2742802|NCT00932425|Primary|Completion of Clinical Follow-up as a Measure of Feasibility|Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable|1 year||||participants|||Number
2742768|NCT00932646|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742769|NCT00932646|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742770|NCT00932646|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742771|NCT00932646|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742772|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742773|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
2742774|NCT00932646|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) date and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.|||Liter||Standard Error|Least Squares Mean
2742775|NCT00932620|Secondary|Changes in Low-density Lipoprotein Cholesterol (LDL-C)||3 months||||LDL-C, mg/dL||Standard Deviation|Mean
2742776|NCT00932620|Primary|Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels||Baseline and 3 months||||sdLDL-C, mg/dL||Standard Deviation|Mean
2742777|NCT00932477|Secondary|The Number of Ophthalmic Adverse Events at 1 Week|The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Number of adverse events|||Number
2742778|NCT00932477|Secondary|Best-Corrected Visual Acuity (BCVA) Status at 1 Week|"BCVA status at 1 week reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more in at least 1 eye; No Change equals change between -2 to +2 lines in either eye; Worse equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly."|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Number of Patients|||Number
2742779|NCT00932477|Secondary|Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week|Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Number of Patients|||Number
2742803|NCT00932399|Primary|% Weight Change From Baseline|Time window for 3 years is 31-39 months after baseline|At ~3 years after baseline||||% weight change||95% Confidence Interval|Mean
2742780|NCT00932477|Primary|Tolerability Questionnaire Mean Scores at 1 Week|Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Scores on a scale||Standard Deviation|Mean
2742781|NCT00932451|Primary|Percentage of Participants With Adverse Events|Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).|||Percentage of Participants|||Number
2742782|NCT00932451|Primary|Objective Response Rate|The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Percentage of participants||95% Confidence Interval|Number
2742783|NCT00932451|Secondary|Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale|The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2742784|NCT00932451|Secondary|Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).|||Percentage of participants|||Number
2742785|NCT00932451|Secondary|Mean Change From Baseline of QLQ-LC13 Scale Scores|"The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (worse) symptom severity, higher (better) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms."|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2742786|NCT00932451|Secondary|Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores|"The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (worse) symptom severity, higher (better) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms."|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2742787|NCT00932451|Secondary|Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.|"The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (worse) symptom severity, higher (better) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms."|6 years|The patient reported outcomes (PRO) evaluable population was defined as the participants from the safety analysis (SA) population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2742788|NCT00932451|Secondary|QTc Prolongation in Participants|The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.|6 years|Participants from the SA population who had a Baseline (last ECG [electrocardiogram] prior to Cycle 1 Day 1 dose) and ≥1 post Baseline ECG measurement and were not included in the ECG sub-study.|||Percentage of participants|||Number
2742818|NCT00932360|Secondary|Fatigue With Movement Difference Score Pre-intervention and Post Intervention|Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.|3 weeks||||units on a scale||Standard Error|Mean
2742839|NCT00932152|Secondary|To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2742789|NCT00932451|Secondary|Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)|The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.|6 years|The All Genotyped Population was defined as all participants in the safety analysis population who had at least 1 genotype result. The Pharmacogenomic Evaluable (PE) Population was defined as participants in the All Genotyped Population who had an HLA genotype result and were designated as an ALT Case or Control.|||Percentage of participants|||Number
2742790|NCT00932451|Secondary|Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)|Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.|6 years|The safety analysis population included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing) and were ALK positive by IUO (SA-ALK positive by IUO population)|||Percentage of cells||Full Range|Median
2742791|NCT00932451|Secondary|Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182|Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.|6 years|All participants who have ≥ 1 measurement of PF-02341066 or PF-06260182 at the time of reporting are included in PK analysis. Concentration at Cycle 2 Day 1 and beyond are considered steady state, and only included those who received at least 14 continuous days of 250 mg BID dosing.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2742792|NCT00932451|Secondary|Probability of Survival|Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.|||Percentage of probability||95% Confidence Interval|Number
2742793|NCT00932451|Secondary|Overall Survival (OS)|OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death − date of Cycle 1 Day 1 dose + 1)/30.4.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.|||Months||95% Confidence Interval|Median
2742794|NCT00932451|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.|||Months||95% Confidence Interval|Median
2742795|NCT00932451|Secondary|Disease Control Rate (DCR)|DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Percentage of participants||95% Confidence Interval|Number
2742796|NCT00932451|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Weeks||Full Range|Median
2742797|NCT00932451|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death − first date of CR or PR that was subsequently confirmed + 1)/30.4.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Months||95% Confidence Interval|Median
2742798|NCT00932425|Primary|Completion of Assigned Monitoring as a Measure of Feasibility|Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset.|21 days|Only patients in the monitoring arm were assessed for compliance with assigned monitoring|||participants|||Number
2742799|NCT00932425|Secondary|Recurrent Stroke or TIA|Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records.|1 year||||participants|||Number
2742800|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||1 year|2 participants in the Control arm were followed for less than 90 days|||participants|||Number
2742804|NCT00932373|Primary|PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.|||day||Standard Deviation|Mean
2742805|NCT00932373|Primary|PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.|||day • μg/mL||Standard Deviation|Mean
2742806|NCT00932373|Primary|Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.|||μg/mL||Standard Deviation|Mean
2742807|NCT00932373|Primary|Maximum Tolerated Dose (MTD)|The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1|||mg/kg|||Number
2742808|NCT00932373|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|"DLT is defined as one of the following as per investigator related to study drug:~Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity~Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging~Grade ≥ 4 thrombocytopenia~Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever~Grade ≥ 4 anemia~Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.~Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22"|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety Population included all treated patients|||participants|||Number
2742809|NCT00932373|Secondary|Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine|After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.|Baseline to the end of the study (up to 3 years 2 months)||||percentage of participants|||Number
2742810|NCT00932373|Secondary|Progression-free Survival|Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.|||Months||95% Confidence Interval|Median
2742811|NCT00932373|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.|||Months||95% Confidence Interval|Median
2742812|NCT00932373|Secondary|Percentage of Participants With an Objective Response|The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.|||percentage of participants|||Number
2742813|NCT00932373|Primary|Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment|"The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.~The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first."|Study treatment initiation until 30 or 90 days after last administration of study treatment|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1|||percentage of participants|||Number
2742814|NCT00932360|Secondary|6 Minute Walk Test Average Change (Feet)|6 minute walk test average change (feet) before and after intervention|3 weeks||||feet||Standard Error|Mean
2742815|NCT00932360|Secondary|PPT for Anterior Tibialis|Pressure pain threshold in leg (kPa)|3 weeks||||pressure score (kPa)||Standard Error|Mean
2742816|NCT00932360|Secondary|PPT Lumbar Region|Pressure pain threshold in lumbar region (kPa)|3 weeks||||pressure score (kPa)||Standard Error|Mean
2742817|NCT00932360|Secondary|PPT Cervical Region|Pressure pain threshold cervical region (kPa)|3 weeks||||pressure score (kPa)||Standard Error|Mean
2742822|NCT00932321|Secondary|Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population|Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.|5.6 months (6 - 28 day cycles)|Modified Intent to Treat (MITT)|||Days||Standard Deviation|Mean
2742823|NCT00932321|Primary|Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population|Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment|5.6 months (6 - 28 day cycles)|Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication.|||Pearl Index|||Number
2742824|NCT00932282|Secondary|Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy|The primary safety outcome of the study is to determine the frequency of side effects during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of allergic symptoms that occur during oral immunotherapy when compared to previously published results|approximately 24 or 36 months||||side effects reported per 100 OIT doses|||Number
2742825|NCT00932282|Secondary|Incidence of All Serious Adverse Events During the Study|A secondary safety outcome of the study is to determine the frequency of SAEs during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of SAEs that occur during oral immunotherapy when compared to previously published results|approximately 24 or 36 months||||SAEs per 100 OIT doses taken|||Number
2742826|NCT00932282|Secondary|The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study|A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical desensitization as measured by passing an oral food challenge to 20 grams of peanut flour on the final day of peanut OIT dosing.|approximately 24 or 36 months||||Participants|||Count of Participants
2742827|NCT00932282|Secondary|The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.|A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to a peanut oral immunotherapy protocol allows for a higher amount of peanut tolerated after the rush desensitization phase, thereby reducing the duration of buildup phase and achieving maintenance dosing more rapidly|4 months||||Participants|||Count of Participants
2742828|NCT00932282|Primary|The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy|The primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy|approximately 24 or 36 months||||Participants|||Count of Participants
2742829|NCT00932165|Primary|Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status||24 weeks|The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy.|||participants|||Number
2742830|NCT00932165|Primary|Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment|Anti-tumor effect was evaluated according to the rules for 'General Rules for Clinical and Pathological Recording of Breast Cancer' (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.|24 weeks|N = number of participants with tumor response|||participants|||Number
2742831|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction|The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.|24 weeks|Subjects with renal Dysfunction.|||participants|||Number
2742832|NCT00932165|Primary|Number of Participants With Adverse Drug Reaction|Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.|||participants|||Number
2742833|NCT00932165|Primary|Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, <50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, >50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)|24 weeks||||participants|||Number
2742834|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction|The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.|24 weeks|Subjects with hepatic Dysfunction.|||participants|||Number
2742835|NCT00932165|Primary|Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.|||participants|||Number
2742836|NCT00932165|Secondary|Number of Participants With Unexpected Adverse Drug Reaction|"Adverse drug reaction that is not included in the precautions for useor undesirable effects section in the package insert (same as Local Product Document)."|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.|||participants|||Number
2742840|NCT00932152|Primary|To Evaluate the Progression-free Survival.||1.5 years|Analysis was not completed because the trial was stopped prematurely due to slow accrual.||||||
2742842|NCT00932126|Secondary|PAK (p21 Activated Kinase)-Related Pathway Molecule Expression Modulation by PF-03758309 in Tumor and Surrogate Tissue||Screening, 0, 2, 4, and 72 hours post dose Cycle 2 Day 8. A 6th sample of hair follicle could be requested at 6 or 8 hours post-dose if necessary. For fresh tumor tissue, baseline and between Day 8 and 22 of Cycle 1 in participants with accessible tumors|Data not analyzed due to early study termination.||||||
2742843|NCT00932126|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
2742844|NCT00932126|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
2742845|NCT00932126|Secondary|Area Under the Concentration-Time Curve From Time 0 to 12 Hours Post Morning Dose [AUC(0-12)]||pre-dose and 12 hours post morning dose|Data not analyzed due to early termination of the study.||||||
2742846|NCT00932126|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
2742847|NCT00932126|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
2742848|NCT00932126|Secondary|Maximum Observed Plasma Concentration (Cmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
2742849|NCT00932126|Secondary|Duration of Response|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.||||||
2742850|NCT00932126|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.||||||
2742851|NCT00932126|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Per protocol analysis set: all participants who have received a minimum of 1 cycle of study treatment (at least 80% of planned dose), had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response.|||participants|||Number
2742852|NCT00932126|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLT)|DLT includes: Grade (GR) 4 neutropenia (NP) that persisted for >7 consecutive days; Febrile NP; GR3 NP infection; GR4 thrombocytopenia (TP); GR3 TP with bleeding; Any other GR>=3 toxicity not classified under Common Terminology Criteria for Adverse Events (CTCAE) blood or bone marrow (exception of nausea, vomiting, or diarrhea in subjects who received optimal treatment with antiemetics or anti-diarrheals); Failure to recover to an adequate condition to recommence study treatment after a 2-week delay; Failure to receive >= 80% of planned PF-03758309 dose due to study drug related toxicity|Baseline (up to 30 days prior to first study drug administration) till 28 days after the last treatment administration (end of Cycle 1 [28 days])|Safety analysis set: All participants enrolled in the study that received at least 1 dose of PF-03758309 (including the lead in dose).|||participants|||Number
2742853|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Photography Completed||Week 0 and Week 16||||participants|||Number
2742854|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Target Lesion Score|The lesion score of a single psoriatic plaque selected at baseline. Total range is 0 - 12 with 0 being clear and 12 representing the most severe disease. The target lesion score is composed of scale, erythema, and induration, each parameter is scored 0 (clear) through 4 (very severe). Totals are summed for target lesion score. S+E+I = TLS|Week 0 and Week 16||||units on a scale||Full Range|Mean
2742855|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: % Body Surface Area||Week 0 and week 16||||percentage of total body surface area||Full Range|Mean
2742856|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)||Week 0 and Week 16||||percentage of subjects|||Number
2743274|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Performance of the Dose Counter for Indicating Approximately How Many Doses Remain in Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2742857|NCT00932113|Other Pre-specified|Additional Gene Analysis (Ongoing)|A single, long-term follow-up visit will be done for all available subjects for additional pharmacogenetic analysis. The goal in collecting DNA from psoriasis patients is to determine if individual subjects have gene variants associated with increased incidence of psoriasis. The investigators plan on analyzing variants using single nucleotide polymorphism (SNP) analysis by high-throughput DNA sequencing. This patient genetic information may allow us to correctly interpret data collected about gene expression levels in affected or non-affected skin. Additionally genetic typing may lead to cogent personalized health care (PHC) strategies for the identification of psoriasis drug responders/non-responders, patients who achieve durable disease remission post-treatment, and/or pharmacodynamic markers, as examples.|long-term follow-up visit 4- 6 years post end of study|||||||
2742858|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: PASI 75|PASI 75 is the percent of subjects who experience an improvement in PASI (Psoriasis Area and Severity Index) score of at least 75% from their baseline PASI score.|Weeks 0 and week 16||||percentage of subjects|||Number
2742859|NCT00932113|Primary|Biologic Activity Endpoints|Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.|Weeks 0, 1, 2, 4 and 16||||fold change||Standard Error|Mean
2742860|NCT00932035|Primary|Percentage of Patients With Lymphedema|Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.|||Participants|||Count of Participants
2742861|NCT00932035|Primary|Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes|A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.|||Participants|||Count of Participants
2742862|NCT00932035|Primary|Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein|A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.|||Participants|||Count of Participants
2742863|NCT00932022|Secondary|Percent Change From Baseline in Percentage of Patients Continent|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
2742864|NCT00932022|Secondary|Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
2742865|NCT00932022|Secondary|Percent Change From Baseline in Voided Volume|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
2742866|NCT00932022|Secondary|Percent Change From Baseline in Urgency Severity Associated With Toilet Voids|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
2742867|NCT00932022|Primary|Percent Change From Baseline in Urinary Urgency Incontinence (UUI)|Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.|Baseline (Week 2), Week 14|Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure.|||Percent change||Standard Deviation|Mean
2742868|NCT00931996|Primary|Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.|Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.|Baseline and 6 weeks|Completers|||units on a scale||Standard Deviation|Mean
2742869|NCT00931918|Secondary|Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher|Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.|Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)|Safety Population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2742870|NCT00931918|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category|Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)|Safety Population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2743275|NCT00928746|Secondary|Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2742871|NCT00931918|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||months||95% Confidence Interval|Median
2742872|NCT00931918|Secondary|Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate|FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.|End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2742873|NCT00931918|Secondary|Duration of Response|Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Participants from the Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment who had a CR or PR|||months||95% Confidence Interval|Median
2742874|NCT00931918|Secondary|Complete Response Rate|Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2742875|NCT00931918|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2742876|NCT00931918|Secondary|Overall Survival|Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||months||95% Confidence Interval|Median
2742877|NCT00931918|Primary|Progression-Free Survival Rate|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.|2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||percentage of participants|||Number
2742892|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 11|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 11 (insight) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2743276|NCT00928746|Secondary|Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2742878|NCT00931918|Primary|Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||months||95% Confidence Interval|Median
2742879|NCT00931879|Primary|Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.||One Year|Measures of vascular response to ischemic block and local warming at the dorsum of the foot were not reliably collected for this assessment due to the difficulty of analysis and the inability to properly distinguish a vascular response in patients.||||||
2742880|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction||One Year||||m/s||Standard Error|Mean
2742881|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.||One Year||||ms||Standard Error|Mean
2742882|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.||One Year||||m/s||Standard Error|Mean
2742883|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.|Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.|One year||||pg/ml||Standard Error|Mean
2742884|NCT00931879|Primary|Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds|Quantitative Sensory Tests (QSTs), including vibration detection threshold, were used to evaluate peripheral sensory perception. Mean represents percent change of total group. Measurements taken at baseline and at one year.|One year||||% Change||Standard Error|Mean
2742885|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.|Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.|One year||||°C||Standard Error|Mean
2742886|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.|Quantitative Autonomic Function Tests (QAFTs) were performed. Primarily, power spectral analysis of heart rate variability (HRV) and time- and frequency-domain analyses, including measures of the sympathetic and parasympathetic control of the heart beat (R-R interval), were recorded with deep breathing, Valsalva, and standing from the sitting position maneuvers. Additionally, the sample difference of the beat to beat (NN) intervals and the TSP was calculated as well as the standard deviation of all normal R-R intervals (sdNN).|One year||||ms||Standard Error|Mean
2742887|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.|19 participants in each arm( placebo or omega-3-ethyl esters 4g) were analyzed . Conduction velocities and amplitude of the following nerves were compared between each arm: Tibial Nerve Ankle Amplitude, Tibial Nerve Popliteal Amplitude, Median Nerve Wrist Amplitude, Median Nerve Elbow Amplitude, Peroneal Motor Nerve Ankle Amplitude, Peroneal Motor Nerve Below Fibular Amplitude, Peroneal Motor Nerve Above Fibular Amplitude, Sensory Median Nerve Wrist Amplitude, Sensory Ulnar, Sensory Sural Ankle Ampltiude Wrist Ampltiude|One year||||uV||Standard Error|Mean
2742888|NCT00931801|Secondary|Change in Quality of Life From Baseline to 48 Weeks of Study Treatment|Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.|baseline and 48 weeks|Data for all participants assigned to a study treatment was analyzed except data for participants that did not have both baseline and week 48 data, including early withdrawal, virologic failure, loss to follow-up or missing data.|||units on a scale||Standard Deviation|Mean
2742889|NCT00931801|Secondary|The Change in Adherence to Study Treatment Arm From Baseline to Week 48|Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.|||percentage of prescribed doses||Standard Deviation|Mean
2742890|NCT00931801|Secondary|The Difference in CD4 From Baseline to Week 48|Change in mean CD4 from Baseline to Week 48.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or lab error.|||cells/mm3||Standard Deviation|Mean
2742891|NCT00931801|Primary|Maintenance of Virologic Suppression|To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.|48 weeks|All enrolled participants were included in this analysis of primary outcome measurement.|||participants|||Number
2742974|NCT00931268|Secondary|Number of Participants With Global Esthetic Improvement|Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.|One month and up to 18 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.|||participants|||Number
2742893|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 10|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 10 (appearance) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742894|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 9|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. . This analysis is for Item 9 (disruptive-aggressive behavior) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742895|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 8|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 8 (content) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742896|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 7|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 7 (language-thought disorder) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742897|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 6|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 6 (speech-rate and amount) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742898|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 5|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 5 (Irritability) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742899|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 4|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43||||Scores on a scale||Standard Error|Least Squares Mean
2742900|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 3|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 3 (sexual interest) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742901|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 2|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 2 (increased motor activity-energy) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742911|NCT00931723|Secondary|The Number of Patients With Clinically Significant Response.|The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|43 days (from baseline to Day 43)|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Participants|||Number
2742902|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 1|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 1 (Elevated mood) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742903|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Positive Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742904|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Activation Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742905|NCT00931723|Secondary|Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742906|NCT00931723|Secondary|Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms.|Change from baseline to Day 43.||||Scores on a scale||Standard Error|Least Squares Mean
2742907|NCT00931723|Secondary|Improvement of Overall Bipolar Illness|"The number of patients with a CGI-BP-C of Much or Very much improved in overall bipolar illness assessment at Day 43 was calculated.~The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement."|Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Participants|||Number
2742908|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)|The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742909|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)|The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742910|NCT00931723|Secondary|Remission|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated.~The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|Days 8 to 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Participants|||Number
2742940|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load <=100,000 copies per mL|||participants|||Number
2742912|NCT00931723|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Change in YMRS total score from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
2742913|NCT00931710|Secondary|Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit|To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.|3, 6, 9 and 12 weeks|Full Analysis Set (FAS).|||cumulative percentage of patients|||Number
2742914|NCT00931710|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks|To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to week 12|Full Analysis Set (FAS). Last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
2742915|NCT00931710|Secondary|Cumulative Percentage of Treatment Responders|To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).|||Cumulative percentage of responders|||Number
2742916|NCT00931710|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Control|To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).|||cumulative percentage of patients|||Number
2742917|NCT00931710|Secondary|Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
2742918|NCT00931710|Primary|Change in Mean Sitting Systolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
2742919|NCT00931632|Secondary|Severity of Bronchopulmonary Dysplasia|Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.|36 weeks|Number of subjects within the Intent-to-treat population with available data|||Participants|||Count of Participants
2742920|NCT00931632|Secondary|Number of Days of Oxygen Use||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Number of subjects within the Intent-to-treat population with available data|||Days||Standard Deviation|Mean
2742921|NCT00931632|Secondary|Systemic Use of Postnatal Corticosteroids for Any Medical Reason||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Intent-to-treat population|||Participants|||Count of Participants
2742922|NCT00931632|Secondary|Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Intent-to-treat population|||Participants|||Count of Participants
2742923|NCT00931632|Secondary|Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Intent-to-treat population|||Participants|||Count of Participants
2742924|NCT00931632|Secondary|Length of Birth Hospitalization||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Number of subjects within the Intent-to-treat population with available data|||Days||Standard Deviation|Mean
2742925|NCT00931632|Secondary|Days of Airway Pressure Support - Intent-to-treat Population|Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.|Through hospital discharge, an average of 105 days for placebo and 108 days for INO||||Days||Standard Deviation|Mean
2742926|NCT00931632|Primary|Survival Without BPD at 36 Weeks||Baseline, 36 weeks PMA|Subjects with missing primary outcome or who crossed over to open-label iNO during the blinded treatment period were considered as failures|||participants|||Number
2742927|NCT00931528|Other Pre-specified|Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline, week 30 and years 1 and 2 after the start of treatment|||||||
2742928|NCT00931528|Other Pre-specified|Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline, week 30 and years 1 and 2 after the start of treatment|||||||
2742929|NCT00931528|Secondary|Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test|The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.|Baseline, week 30 and years 1 and 2 after the start of treatment|Consenting spouses of randomized, eligible patients with data at baseline and time point of interest|||change in LMAT score||Standard Error|Mean
2742930|NCT00931528|Secondary|Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test|The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.|Baseline, week 30 and years 1 and 2 after the start of treatment|Eligible patients with data at baseline and time point of interest.|||change in LMAT score||Standard Deviation|Mean
2742931|NCT00931528|Secondary|Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score|The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.|Baseline, week 30 and years 1 and 2 after the start of treatment|Consenting partners of randomized eligible patients with data at baseline and corresponding time point|||change in SAQ score||Standard Deviation|Mean
2742932|NCT00931528|Secondary|Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score|The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.|Baseline, week 30 and years 1 and 2 after the start of treatment|Eligible patients with data at baseline and corresponding time point|||change in SAQ score||Standard Deviation|Mean
2742933|NCT00931528|Secondary|Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)|The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.|Baseline, week 30, and years 1 and 2 from start of treatment|Eligible patients with IIEF at baseline and corresponding time points.|||change in total IIEF||Standard Deviation|Mean
2742934|NCT00931528|Secondary|Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT|"The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks How often were you able to get an erection during sexual activity? Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure."|Baseline, 1 and 2 years from the start of tadalafil or placebo|All randomized eligible patients with IIEF at both baseline and corresponding time point.|||percentage of participants||95% Confidence Interval|Number
2742935|NCT00931528|Primary|Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)|"EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks How often were you able to get an erection during sexual activity? Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure."|Baseline and 30 weeks from the start of radiation therapy|All randomized eligible patients with IIEF at both baseline and 30 week time point.|||percentage of participants||95% Confidence Interval|Number
2742936|NCT00931515|Primary|Participants With Improved Patient Function|"The comparison of results was based on the proportion of participants with improved outcomes.~The primary efficacy variable was treatment success based on the following criteria:~Oswestry Disability Index score improved by at least 15 points~Device success~Neurological success~Absence of major complications~Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure."|24 months||||participants|||Number
2742937|NCT00931489|Secondary|Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6|Ocular Coherence Tomography (OCT) was used to measure retinal central foveal thickness. The mean change from baseline to 6 months was determined and recorded in micrometers (µm).|6 months|"At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of non-responder following 4 months of treatment)."|||µm||Full Range|Mean
2742938|NCT00931489|Secondary|Change in Visual Acuity (VA) From Baseline to Month 6|Subjects visual acuity (VA) was tested using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letters correctly read on ETDRS chart was recorded at baseline and 6 months. Mean change was measured.|6 months|"At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of non-responder following 4 months of treatment)."|||letters gained||Full Range|Mean
2742939|NCT00931489|Primary|"Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular (Wet) Age-related Macular Degeneration Patients Compared to Population Normals."|Blood samples were collected from all study participants at baseline and Western Blot analysis was performed to identify the presence of anti-retinal and anti-RPE antibodies. Presented are the number of subjects in which the presence of anti-retinal and anti-RPE antibodies (yes/no) were recorded by a masked observer.|6 months|"The wet AMD patients' 6 month values in production of RPE or anti-retinal antibody formation are being compared to the Normal Population baseline values."|||participants|||Number
2743277|NCT00928746|Secondary|Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2742941|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL|The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load >100,000 copies per mL|||participants|||Number
2742942|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure|"The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:~i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy"|48 weeks|Non-completer classes as failure|||participants|||Number
2742943|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Per protocol|||participants|||Number
2742944|NCT00931463|Primary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization||48 weeks following randomization|modified intention-to-treat|||participants|||Number
2742945|NCT00931411|Secondary|Preferred Formulation|Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered.|56 days|All subjects with an evaluation after the Day 42 visit were included in this evaluation if their overall compliance was between 70 and 120%. Two patients lost to follow-up, one with no Day 56 value and 5 less than 70% compliant were not included in this analysis.|||Participants|||Number
2742946|NCT00931411|Secondary|Change in Mean Tolerance After Crossover|"Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):~1) Very good tolerance: no objective or subjective intolerance during the study~2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign~3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign~4) Poor tolerance: symptoms requiring cessation of application, no objective sign~5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|14 Days (Day 42 to Day 56 of the study)|All subjects that had at least one evaluation after Day 7 (no day 0 visit for this parameter) were included in the analysis. Missing data were replaced using the last observation carried forward method. The same patients as in outcome #7 did not have results to carry forward and were not included in analysis (subjects swapped after crossover).|||Units on a scale||Standard Deviation|Mean
2742947|NCT00931411|Secondary|Change in Tolerance Before Crossover|"Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:~1) Very good tolerance: no objective or subjective intolerance during the study~2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign~3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign~4) Poor tolerance: symptoms requiring cessation of application, no objective sign~5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|7, 42 days|All subjects that had at least one evaluation after the Day 7 (no Day 0 visit for this parameter) visit were included in the efficacy evaluations. Missing data were replaced using the last observation carried forward (LOCF) method. Four patients had no Day 7 visit to carry forward and were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
2742948|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability After Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study.|14 days (Day 42 to Day 56 of the study)|Subjects that had at least one evaluation after the Day 0 visit were in analysis if they had overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward. Two patients lost to follow-up, 1 early term and 5 less than 70% compliant were not included in this analysis and participants swapped after crossover.|||Units on a scale||Standard Deviation|Mean
2742949|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability Before Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in the cosmetic evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
2742950|NCT00931411|Secondary|Change in Mean Quality of Life|The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in this evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
2742951|NCT00931411|Secondary|Change in Mean Global Efficacy (by Parent)|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent).~0 = worsening~1 = No change~2 = Mild Improvement~3 = Moderate Improvement~4 = Good Improvement~5 = Excellent Improvement"|7, 42 days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, two missing Day 7 value and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
2743278|NCT00928746|Secondary|Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||95% Confidence Interval|Median
2742952|NCT00931411|Secondary|Change in Mean Global Efficacy (by Investigator).|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator).~0 = worsening~1 = No change~2 = Mild Improvement~3 = Moderate Improvement~4 = Good Improvement~5 = Excellent Improvement"|7, 42 Days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, one missing Day 7 value and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
2742953|NCT00931411|Primary|Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0|The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.|7 , 42 days|All subjects that had at least one evaluation after the Day 0 visit were included in the efficacy evaluations if their overall compliance was between 70 and 120%. Missing data were replaced using the last observation carried forward (LOCF) method. Two patients lost to follow-up and 5 less than 70% compliant were not included in this analysis.|||Percentage of change in SCORAD||Standard Deviation|Mean
2742954|NCT00931385|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.|||participants|||Number
2742955|NCT00931385|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742956|NCT00931385|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742957|NCT00931385|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
2742958|NCT00931385|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742959|NCT00931385|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742960|NCT00931385|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742961|NCT00931385|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
2742962|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742963|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
2742964|NCT00931385|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
2742965|NCT00931385|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) data and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.|||Liter||Standard Error|Least Squares Mean
2742966|NCT00931359|Secondary|Percentage of Subjects With Reported Adverse Events|Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.|6 months post-treatment||||Percentage of Participants|||Number
2742967|NCT00931359|Secondary|Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit|"The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit."|12 months|Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.|||Percentage of Participants|||Number
2742968|NCT00931359|Secondary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities"|6 months post-treatment||||Percentage of Participants|||Number
2742969|NCT00931359|Primary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities"|30 days post-treatment|Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.|||Percentage of Participants|||Number
2742970|NCT00931307|Primary|Comfort After Insertion|Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||Scale of 1 to 10||Standard Deviation|Mean
2742971|NCT00931268|Secondary|Time Until it Became Impossible to Stay Sitting|"Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis more than 60 minutes was handled as 60 minutes."|Baseline and at 6 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.|||minutes||Standard Deviation|Mean
2742972|NCT00931268|Secondary|Adverse Event Recording|Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).|Up to 18 months after treatment|Reported AEs, Safety population|||participants|||Number
2742973|NCT00931268|Secondary|Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)|MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below.|12 months after treatment||||participants|||Number
2742975|NCT00931268|Secondary|Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire|A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.|Baseline and at 6 months after treatment|The physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 10 treated subjects.|||units on a scale||Standard Deviation|Mean
2742976|NCT00931268|Secondary|Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|"Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = no pain to the left and 100 = worst possible pain to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline."|Baseline and up to 18 months after treatment|The VAS pain at 1, 3, 9, 12 and 18 months after treatment was compared to baseline. Of 10 treated subjects the ITT populations at each time point was: 9 (1 month), 8 (3 months), 7 (9 months), 5 (12 months) and 4 (18 months).|||mm||Standard Deviation|Mean
2742977|NCT00931268|Primary|Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|"Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = no pain to the left and 100 = worst possible pain to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated."|6 months after treatment compared to baseline|All efficacy analyses were performed using the intention to treat (ITT) population. The ITT population at baseline and 6 months comprised all 10 treated subjects.|||mm||Standard Deviation|Mean
2742978|NCT00931255|Secondary|Change in Inflammatory Marker, MCP, From Baseline||1 year||||pg/mL||Standard Deviation|Mean
2742979|NCT00931255|Secondary|Change in Inflammatory Marker, IL-6 From Baseline||1 Year||||pg/mL||Standard Deviation|Mean
2742980|NCT00931255|Secondary|Change in Inflammatory Marker : CRP From Baseline||1 year||||mg/L||Standard Deviation|Mean
2742981|NCT00931255|Secondary|Incidence of BK Nephropathy (Cumulative)||1 year||||participants|||Number
2742982|NCT00931255|Secondary|Incidence of Acute Rejection (Actual, Actuarial)||1 year||||participants|||Number
2742983|NCT00931255|Secondary|Graft Survival (Actual, Actuarial)||1 year||||participants|||Number
2742984|NCT00931255|Secondary|Change in eGFR From Baseline to 1-year||1 year||||mL/min per 1.73 m^2||Standard Deviation|Mean
2742985|NCT00931255|Secondary|eGFR||One year||||mL/min per 1.73 m^2||Standard Deviation|Mean
2742986|NCT00931255|Primary|The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values||One year||||participants|||Number
2742987|NCT00931242|Secondary|Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks||||participants|||Number
2742988|NCT00931242|Secondary|Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks||||participants|||Number
2742989|NCT00931242|Primary|Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points|Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12|12 weeks||||participants|||Number
2742990|NCT00931164|Secondary|Neuropsychological Tests||Week 14|||||||
2742991|NCT00931164|Secondary|Functional Skills Questionnaires||Week 14|||||||
2742992|NCT00931164|Secondary|Mood and Behavior Questionnaires||Week 14|||||||
2742993|NCT00931164|Secondary|Quality of Life Questionnaires||Week 14|||||||
2742994|NCT00931164|Secondary|Mean Daily Percentage of Time That Functional Status is Affected Due to Episodes||Week 14|||||||
2742995|NCT00931164|Primary|Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase||1 year||||participants|||Number
2742996|NCT00931164|Primary|Observed Safety Data During 5-day Hospitalization for Drug Dose Identification||Week 7|||||||
2742997|NCT00931164|Primary|Time Duration of AHC Episodes||Week 7|||||||
2742998|NCT00930982|Other Pre-specified|Change From Baseline in Total Bacterial Load in the Sputum|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL on Day 8. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. Decadic logarithm of colony forming units (CFUs) per gram sputum|||log10 of CFU per gram sputum||Standard Deviation|Mean
2743299|NCT00928668|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline to Visit 6|All patients in the Safety set who have a baseline value and post dose values for each planned time.|||mmol/L||Inter-Quartile Range|Geometric Mean
2742999|NCT00930982|Secondary|Emergence of Resistance Among Baseline Pathogens|The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Participants|||Number
2743000|NCT00930982|Secondary|Emergence of New Potential Respiratory Pathogens|The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Cumulative participants|||Number
2743001|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Pathogen|Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Participants|||Number
2743002|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Participant|Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percentage of participants|||Number
2743003|NCT00930982|Secondary|24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percentage of participants|||Number
2743004|NCT00930982|Secondary|24-hour Sputum Volume|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||mL||Standard Deviation|Mean
2743005|NCT00930982|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC)|Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||giga/L||Standard Deviation|Mean
2743006|NCT00930982|Secondary|Change From Baseline in High Sensitive C-reactive Protein (hsCRP)|High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||mg/L||Inter-Quartile Range|Median
2743007|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)|Participants completed the Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Total score on a scale||Standard Deviation|Mean
2743008|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score|Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Scores on a scale||Standard Deviation|Mean
2743009|NCT00930982|Secondary|Time to Exacerbation With Antibiotic Intervention|Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. NA: due to fewer than 25% of participants having an exacerbation|||Days||Inter-Quartile Range|Median
2743010|NCT00930982|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percent of predicted FVC||Standard Deviation|Mean
2743011|NCT00930982|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percent of predicted FEV1||Standard Deviation|Mean
2743012|NCT00930982|Primary|Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and 29 days|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||log10 of CFU per gram sputum||Standard Deviation|Mean
2743013|NCT00930969|Secondary|Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.|When study subjects completed their six-month follow-up visit, they were asked if they would consent to wear a Holter monitor for a period of 24 hours to collect Heart Sounds data. The study subject would have to return to the center the following day to return the Holter monitor and have their ICD EGM vectors reprogrammed.|Six-month follow-up visit|A subset of participants opting to wear a Holter monitor for 24 hours to collect Heart Sounds data, and then returning the following day for device reprogramming.|||Participants|||Number
2743014|NCT00930969|Secondary|Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.|The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease. This additional capacity of the device is not currently available in market release ICDs. There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore the number of years of stored device data to utilize for future research as collected by the implanted ICD in the remaining 173 subjects was analyzed.|||Years|||Number
2743015|NCT00930969|Secondary|ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test|Patients underwent an exercise stress test at their one month study visit. This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.|One-month follow-up visit||||millivolts||Standard Deviation|Mean
2743016|NCT00930969|Secondary|Occurrence of Spontaneous Coronary Event|During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina. This objective was to provide estimates of rates per patient year for the study population. Rates are presented as: Average number of events per patient year (95% Confidence Interval)|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore data collected by the implanted ICD in the remaining 173 subjects was analyzed.|||Events per patient year||95% Confidence Interval|Number
2743017|NCT00930969|Primary|Number of Participants With ST Segment Changes During Myocardial Infarction|The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.|Implant to 2 years|During the study, none of the subjects presented with a ST Elevation Myocardial Infarction (STEMI). Therefore, there was not the opportunity to measure the hearts electrical activity during one of these events.||||||
2743018|NCT00930930|Other Pre-specified|Ability of p63 and p73 Gene Signatures to Predict Patient Response|To determine the levels of P63 and p73 in order to correlate these levels with patient response to treatment to help define a biomarker signature associated with p63/p73 dependence in triple negative breast cancers|Before treatment, on day 3-5 of week 1, and at week 12|||||||
2743019|NCT00930930|Other Pre-specified|Therapy-mediated Changes in Cell Cycle Position, Proliferation, and Apoptosis as Well as Status, Levels, and Phosphorylation State of p53, p73, and p63 and Select p53 Family Target Genes|To determine the relevance of pathway modulation in triple negative breast cancer cell networking|Before treatment, on day 3-5 of week 1, and at week 12|||||||
2743020|NCT00930930|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Tables represent the number of patients with their worst-grade toxicity at each of five grades (grade 1, least severe to grade 5, most severe) following NCI Common Toxicity Criteria. Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables.|week 12|Total number of patients reported with any toxicity related to study treatment.|||participants|||Number
2743412|NCT00928187|Secondary|Patients With Plasma HIV RNA < 200 Copies/ml|number of patients with plasma HIV RNA below 200 copies/ml|48 weeks|ITT|||participants|||Number
2743021|NCT00930930|Secondary|Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|After treatment, week 12-15|Patients reported by best overall response data. Patients are excluded if best overall response data is not accessible or not evaluable.|||participants|||Number
2743022|NCT00930930|Secondary|Number of Patients That Underwent Breast Conservation Surgery|Defined as patients that did not undergo complete removal of a cancerous breast (mastectomy).|at the time of surgery, week 15-18|participants that had breast conservation surgery|||participants|||Number
2743023|NCT00930930|Primary|Number of Patients With Pathological Complete Response|Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.|at time of surgery, week 15-18|Number of patients that had complete response. Specimens containing only non-invasive disease will be classified as complete pathologic responders|||participants|||Number
2743024|NCT00930813|Secondary|Serum Paclitaxel Levels - in Subsets of Patients||0, 1, 3 hours and pre-discharge|||||||
2743025|NCT00930813|Secondary|Change in Rutherford Grade||pre-procedure,6, 12 and 24 months|||||||
2743026|NCT00930813|Secondary|Change in Walking Impairment Questionnaire (WIQ)||pre-procedure, 6, 12 and 24 months|||||||
2743027|NCT00930813|Secondary|Change in Ankle-brachial Index||pre-procedure, 6, 12 and 24 months|||||||
2743028|NCT00930813|Secondary|Procedural Success|Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)|at procedure|||||||
2743029|NCT00930813|Secondary|Device Success|Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).|at procedure|||||||
2743030|NCT00930813|Secondary|Target Vessel Revascularization||6, 12, 24 months|||||||
2743031|NCT00930813|Secondary|Target Lesion Revascularization||6, 12, 24 months|||||||
2743032|NCT00930813|Secondary|Primary Patency of Treated Segment||6, 12, 24 months|||||||
2743033|NCT00930813|Secondary|Safety - Device Related Adverse Events||30 days|ITT|||participants|||Number
2743034|NCT00930813|Primary|Angiographic Late Lumen Loss|Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.|6 months|Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.|||mm||Standard Deviation|Mean
2743035|NCT00930787|Primary|Incidence of Surgical Site Events (SSEs)||Postoperative Day 30|Study was terminated early and no analyses were conducted.||||||
2743036|NCT00930774|Secondary|Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)|Three subscale questionnaire that examines reported change in auditory disability for Speech, Spatial hearing and Quality of sounds. Subjects respond on a scale of -5 ('much worse') to +5 (much better) to indicate the change in difficulties following an intervention they have hearing in specific situations, with a lower number indicating greater difficulty. Results are presented for average total SSQ-C score which can range from -5 to +5, with higher scores indicating greater improvement.|Immediately post-intervention|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
2743037|NCT00930774|Secondary|Cognitive Self Report Questionnaire (CSRQ).|CSRQ assesses self-reported cognitive difficulties in 8 domains: Attention, Executive function, Memory, Language, Vision, Hearing, Energy,and Satisfaction. Participants respond on a 3-point Likert scale whether they perceived they improved, remained the same, or got worse as a result of an intervention. Total score is computed by summing scores on each subscale. Range for total score = -64 to +64, with higher scores indicating fewer reported cognitive difficulties.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
2743038|NCT00930774|Secondary|Time Compressed Speech Test (TCST)|the TCST assessed speech recognition for speeded speech. Sentences are presented in the sound field in quiet at with 50% and 60% time compression. Participants repeat back each sentence after it is presented.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||percent correct||Standard Deviation|Mean
2743039|NCT00930774|Secondary|Digit Span Score Measure of Auditory Working Memory|The Digit Span subtest of the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III) assessed auditory working memory. It consists of a Digit Span Forward task in which individuals to repeat numbers in the same sequence as they were presented verbally, and a Digit Span Backward task in which individuals repeat back the numbers in the reverse order to which they were heard. Data are summed to compute a Digit Span total score. Possible range of scores is 0 to 30, with higher scores indicating better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
2743040|NCT00930774|Secondary|Staggered Spondaic Word Test|Dichotic listening test in which two spondaic words are presented, one to each ear of the listener, in an overlapping fashion such that the first syllable of the first word is presented in isolation, the second syllable of the first word is presented simultaneously with the first syllable of the second word, and the second syllable of the second word is presented in isolation. Total number of test spondee pairs = 40.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||total errors||Standard Deviation|Mean
2743041|NCT00930774|Secondary|Hearing in Noise Test|Hearing In Noise Test assesses speech understanding in noise assessed. Sentences are presented in a background of noise. The signal to noise ratio is varied adaptively to obtained the signal to noise ratio at which participants can correctly repeat back 50% of sentences presented in speech-shaped noise is determined. A lower signal to noise ratio indicates better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||Decibels (signal to noise ratio)||Standard Deviation|Mean
2743042|NCT00930774|Primary|Stroop Color and Word Test|Measure of processing interference that assesses the ability to cope with cognitive stress and process complex input. It consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a Color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The test-taker looks at each sheet and moves down the columns, reading words or naming the ink colors as quickly as possible within a time limit. Interference raw scores were converted into t-scores for analysis. T-score benefit was the analytic metric used. T-score benefit = post-intervention score minus baseline score|Baseline and Immediately post-intervention (between weeks 8 and 12).|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||t-score benefit||Standard Deviation|Mean
2743043|NCT00930774|Primary|Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)|Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change|Immediately post-intervention between weeks 8 and 12|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
2743044|NCT00930761|Secondary|Maternal Breastfeeding at 60 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 60 days after the infant hospital discharge||||participants|||Number
2743045|NCT00930761|Primary|Maternal Breastfeeding 7-15 Days After Discharge|Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the first follow-up visit (7-15 days after discharge)|Analysis was by intention to treat (ITT)|||participants|||Number
2743046|NCT00930761|Secondary|Maternal Breastfeeding at 30 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 30 days after the infant hospital discharge|Analysis by intention to treat (ITT)|||participants|||Number
2743047|NCT00930761|Primary|Maternal Breastfeeding at Infant Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the time of the infant hospital discharge|Analysis by intention to treat (ITT)|||participants|||Number
2743048|NCT00930722|Secondary|Number of Participants With Preference for add-on Anti-hypertensive Therapy|"The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was None."|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.|||Participants|||Number
2743049|NCT00930722|Secondary|Mean Daily Dose of Study Medication|The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.|||mg||Standard Deviation|Mean
2743050|NCT00930722|Secondary|Duration of Monotherapy With Quinapril|"Time in weeks to the first taking additional antihypertensive medication since Quinapril therapy began."|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed. Due to limited number of participants available, the analysis could not be performed.|||Weeks||Inter-Quartile Range|Median
2743150|NCT00929656|Primary|Wolf Motor Function Test Change|Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention). The time to complete 15 separate upper extremity functional tasks are recorded. These 15 separate timed events are averaged to provide one time, in seconds. This is considered an Activity Measure on the WHO ICF model.|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||seconds||Standard Error|Mean
2743051|NCT00930722|Secondary|Number of Participants With Achievement of BP Goal at Week 52|"The status of achieving a participant's goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of DM or renal disease. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease."|Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.|||Participants|||Number
2743052|NCT00930722|Secondary|Number of Participants Achieving BP Goal at Week 12|"The status of achieving a participant's goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of Diabetes Mellitus (DM) or renal disease. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease."|Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Subgroup analysis was performed for each subgroup of participants in the FAS defined by DM or renal disease status. Missing values were imputed by LOCF.|||Participants|||Number
2743053|NCT00930722|Secondary|Change From Pre-treatment in DBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.|||mmHg||Standard Deviation|Mean
2743054|NCT00930722|Secondary|Change From Pre-treatment in SBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.|||mmHg||Standard Deviation|Mean
2743055|NCT00930722|Secondary|Change From Baseline in DBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.|||mmHg||Standard Deviation|Mean
2743056|NCT00930722|Secondary|Change From Baseline in SBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The “full analysis set – follow up” (FAS-FU) included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.|||mmHg||Standard Deviation|Mean
2743057|NCT00930722|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by LOCF.|||mmHg||Standard Deviation|Mean
2743058|NCT00930722|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by last-observation-carried forward (LOCF).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2743059|NCT00930722|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to Week 52|Full analysis set (FAS) included participants who received at least 1 dose of study medication including those who took it before enrollment.|||Participants|||Number
2743060|NCT00930644|Secondary|Number of Subjects Achieving PN/IV Reduction|The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.|24 Months or Last Dosing Visit||||participants|||Number
2743061|NCT00930644|Primary|Absolute Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.|24 months||||Liters||Standard Deviation|Mean
2743062|NCT00930644|Primary|Percent Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.|24 months||||percent change||Standard Deviation|Mean
2743063|NCT00930553|Secondary|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison|EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
2743064|NCT00930553|Secondary|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6|EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
2743151|NCT00929643|Secondary|Percentage of Participants by Diagnosis at Discharge||Month 6 or study exit|FAS|||Percentage of participants|||Number
2743065|NCT00930553|Secondary|Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison|FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
2743066|NCT00930553|Secondary|Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6|FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
2743067|NCT00930553|Secondary|Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison|"SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for CAMMS323 and CAMMS324 participants, respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
2743068|NCT00930553|Secondary|Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
2743069|NCT00930553|Secondary|Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison|"SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for CAMMS323 and CAMMS324 participants, respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
2743098|NCT00929981|Secondary|Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits|Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred).|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2743070|NCT00930553|Secondary|Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for alemtuzumab treatment CAMMS323 extension group, alemtuzumab Treatment CAMMS324 Extension group, respectively),Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
2743071|NCT00930553|Secondary|Percentage of Relapse Free Participants|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
2743072|NCT00930553|Secondary|Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6|Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2743073|NCT00930553|Secondary|Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity|Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
2743074|NCT00930553|Secondary|Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6|Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2743075|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date.|Retreatment Baseline, Year 1, 2 and 3 after retreatment|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.|||percentage of participants|||Number
2743076|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||percentage of participants|||Number
2743077|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
2743078|NCT00930553|Secondary|Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points.|Retreatment baseline, Year 1, 2 and 3 after retreatment baseline|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.|||units on a scale||Standard Deviation|Mean
2743130|NCT00929708|Primary|FEV1, E24−26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)|change from baseline|24h, 26h||||Litre||Standard Deviation|Mean
2743131|NCT00929708|Primary|FEV1, E0−4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)|change from baseline|0,5 min, 15 min, 60 min, 2 h, 4 h||||Litre||Standard Deviation|Mean
2743079|NCT00930553|Secondary|Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison|"EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for CAMMS323 participants and CAMMS324 participants respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
2743080|NCT00930553|Secondary|Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
2743081|NCT00930553|Secondary|Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study|SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Extension study (CAMMS03409) baseline up to Extension Year 2|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. Number of participants analyzed = participants with available data for this outcome measure.|||Participants|||Count of Participants
2743082|NCT00930553|Secondary|Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6|SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure.|Baseline (Year 0) up to Year 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||Participants|||Count of Participants
2743083|NCT00930553|Primary|Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison|SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||Participants|||Count of Participants
2743084|NCT00930553|Primary|Number of Participants With Sustained Accumulation of Disability (SAD)|"SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for alemtuzumab treatment CAMMS323 extension group and alemtuzumab Treatment CAMMS324 Extension group, respectively."|Baseline (Year 0) up to Year 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324.|||Participants|||Count of Participants
2743085|NCT00930553|Primary|Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.|Year 1 prior to retreatment, Year 1, 2, 3 after retreatment|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.|||relapses per participant per year||95% Confidence Interval|Number
2743086|NCT00930553|Primary|Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||relapses per participant per year||95% Confidence Interval|Number
2743087|NCT00930553|Primary|Annualized Relapse Rate (ARR)|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.|"Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively)"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||relapses per participant per year|||Number
2743088|NCT00930293|Secondary|Weeks to Depression Remission|"Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).~Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)"|Measured at baseline and weekly for up to 20 weeks of treatment||||weeks||Standard Error|Mean
2743089|NCT00930293|Primary|Number of Participants Meeting Depression Remission Criteria|Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7|Measured at baseline and weekly for up to 20 weeks of acute treatment||||participants|||Number
2743090|NCT00930176|Primary|FX:C Half-life|Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment|At Baseline and at 6 months post-Baseline||||hours||Geometric Coefficient of Variation|Geometric Mean
2743091|NCT00930176|Primary|FX:C Incremental Recovery|"Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg).~Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment"|At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)||||IU/dL per IU/kg||Geometric Coefficient of Variation|Geometric Mean
2743092|NCT00930046|Secondary|FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points|"Observational FLACC pain intensity assessment tool that consists of observing the Faces Legs Activity Cry Consolability (FLACC) by the bedside nursing staff. This pain assessment tool is validated in non-verbal children and children at 7 years and younger.~Minimum value is 0 and the maximum value is 10, where 0 represents no pain which is a better outcome."|48 hours post-operatively||||score on a scale||Standard Deviation|Mean
2743093|NCT00930046|Primary|Morphine|Total amount of morphine used in the first 48hrs immediately after surgery|48 hours||||mg/kg per 48 hours||Standard Deviation|Mean
2743094|NCT00929994|Secondary|Cognition|Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.|Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation|TIA. Three subjects did not complete the assessment at each time point.|||units on a scale||Standard Deviation|Mean
2743095|NCT00929994|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D).|Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).|Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation|Transient Ischemic Attack. Two patients did not complete questionnaires.|||score on a scale||Standard Deviation|Mean
2743096|NCT00929994|Primary|Cardiovascular Fitness (VO2peak)|To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.|Baseline (after the 3 month non-intervention period) and after 6 months of participation.||||ml/kg/min||Standard Deviation|Mean
2743097|NCT00929994|Primary|Functional Walk Test|6 minute walk test: the longest distance a person can walk for a duration of 6 minutes|Baseline, 3 months, 6 months (Six Minute Walk Distance)|Transient Ischemic Attack participants who completed the 6 month intervention.|||meters||Standard Deviation|Mean
2743132|NCT00929695|Secondary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
2743099|NCT00929981|Secondary|Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits|Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2743100|NCT00929981|Secondary|Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits|Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2743101|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Final Follow-up Visit|"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4."|Final follow-up visit (between Day 25 to 35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2743102|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Third Follow-up Visit|"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4."|Third follow-up visit (between Day 6 to 10 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2743103|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the First Follow-up Visit|"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4."|First follow-up visit (between Day 6 to 10 after start of treatment)|FAS population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2743104|NCT00929981|Primary|Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit|"The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4."|Second follow-up visit (Day 5-28)|Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2743105|NCT00929864|Secondary|Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population|The induction of autoantibodies was defined as participant's antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate.|Day 1 to Day 729|ITT population was defined as all participants randomized into the study who received at least one dose of study drug; number analyzed was ITT participants with data at each time point and who had negative ANA or dsDNA at baseline (m)|||Percentage of participants||95% Confidence Interval|Number
2743106|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 729|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.|||incidence/100 person-years||95% Confidence Interval|Number
2743133|NCT00929695|Secondary|Chronic Extensive GVHD|Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
2743149|NCT00929656|Secondary|Upper Extremity Fugl-Meyer Motor Assessment Change|Change in Score from Pre-intervention to Post-Intervention. This outcome measures arm motor control; the ability to move outside of pathologic synergistic patterns. It is a measure of impairment in Body Structure/Function. Total score ranges from 0-66, with 0 indicative of no movement and 66 considered normal motor control.|Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||units on a scale||Standard Error|Mean
2743107|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.|||incidence/100 person-years||95% Confidence Interval|Number
2743108|NCT00929864|Secondary|Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population|Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose.|Baseline to Day 729|ITT population: all subjects randomized into the study who received at least one dose of study drug. Number analyzed: m=number of ITT participants with both BL and post-BL total score: Day 365: m=295, 297;Day 729 m=257 and 260, in abatacept and adalimumab arms, respectively. n=number without progression. CI based on normal approximation.|||percentage of participants||95% Confidence Interval|Number
2743109|NCT00929864|Secondary|Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population|Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs.|Day 1 to Day 729|ITT population: all participants randomized into the study who received at least one dose of study drug. Participants with a pre-specified local injection site event at 24 Months: 13, 34, in abatacept and adalimumab arms, respectively. 24 Month Exposure=579.21, 532.99, respectively.|||incidence/100 person years||95% Confidence Interval|Number
2743110|NCT00929864|Secondary|Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population|n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period.|Day 1 to 12 Months|The ITT analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 12/318, 30/328 in abatacept and adalimumab, respectively. CI based on normal approximation.|||percentage of participants||95% Confidence Interval|Number
2743111|NCT00929864|Primary|The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population|Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 206/318 and 208/328 in the abatacept and adalimumab arms, respectively.|||percentage of participants||95% Confidence Interval|Number
2743112|NCT00929838|Primary|Hemoglobin A1c (HbA1c) at 12 Months Post Randomization||12-months post randomization|Final analysis used baseline A1c analysis of covariance for differences in levels of A1c between the treatment groups at 12months with baseline A1c as covariate.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2743113|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.|baseline and one hour||||degrees||Standard Deviation|Mean
2743152|NCT00929643|Secondary|Percentage of Participants With Specific Pathogen||Baseline up to 6 months|FAS|||Percentage of participants|||Number
2743114|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.|baseline and one hour||||degrees||Standard Deviation|Mean
2743115|NCT00929773|Primary|Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.|baseline and one hour||||units on a scale||Standard Deviation|Mean
2743116|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment|one hour||||degrees||Standard Deviation|Mean
2743117|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment|baseline and one hour||||degrees||Standard Deviation|Mean
2743118|NCT00929773|Primary|Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.|baseline and one hour||||participants|||Number
2743119|NCT00929734|Secondary|Relative Change in Interleukin 6||Baseline to 3 months|Complete case analysis|||percent change||Inter-Quartile Range|Median
2743120|NCT00929734|Secondary|Relative Change in High-sensitivity C-reactive Protein||Baseline to 3 months|Complete case analysis|||percent change||Inter-Quartile Range|Median
2743121|NCT00929734|Secondary|Relative Change in FEV1||Baseline to 3 months|Complete case analysis|||percent change||95% Confidence Interval|Mean
2743122|NCT00929734|Primary|Relative Change in Reactive Hyperemia Index (RHI)|Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.|Baseline to 3 months|Complete case analysis|||percent change||95% Confidence Interval|Mean
2743123|NCT00929708|Secondary|Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)|The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)|At baseline (visit 2) and after 4 weeks of treatment (visit 5).||||Score||Standard Deviation|Mean
2743124|NCT00929708|Secondary|Overall Mean CCQ (Clinical COPD Questionnaire)|Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.|Mean over week 0, mean over week 1, mean over week 2, and mean over week 4||||score on scale||Standard Deviation|Mean
2743125|NCT00929708|Secondary|Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)|Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.|Daily, during run-in and treatment||||total score||Standard Deviation|Mean
2743126|NCT00929708|Secondary|Total Number of Reliever Medication Inhalations Per 24h|Change from run-in|During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.||||Number of reliver inh.||Standard Deviation|Mean
2743127|NCT00929708|Secondary|FEV1 Post Salbutamol Inhalation|Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5|Baseline (visit 2) and 26 h after the last morning dose (visit 5).||||Litre||Standard Deviation|Mean
2743128|NCT00929708|Secondary|AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.|||nmol*h/L||Full Range|Geometric Mean
2743129|NCT00929708|Secondary|Cmax; the Highest Plasma Concentration of AZD3199 Measured|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.|||nmol/L||Full Range|Geometric Mean
2743134|NCT00929695|Secondary|Secondary Therapy for Acute GVHD Beyond Prednisone|This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.|At approximately 100 days after transplant||||percentage of participants|||Number
2743135|NCT00929695|Secondary|Progression to Grade III-IV Acute GVHD|Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.|At approximately 100 days after transplant||||percentage of participants|||Number
2743136|NCT00929695|Secondary|Recurrent or Progressive Malignancy|Percentage of relapse estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
2743137|NCT00929695|Secondary|Non-relapse Mortality|Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
2743138|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Quality of Life|Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.|Baseline and then every other week until 42 days after starting treatment||||units on a scale||Full Range|Mean
2743139|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hypertension|The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.|Baseline and then through 42 days after starting treatment||||medications||Full Range|Mean
2743140|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Myopathy|Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.|Baseline and then weekly until 42 days after starting treatment||||units on a scale||Full Range|Mean
2743141|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)|The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.|Baseline and through 100 days of treatment||||percentage of participants|||Number
2743142|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hyperglycemia|Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.|Baseline and then through 42 days after starting treatment||||mg/dL||Standard Error|Mean
2743143|NCT00929695|Primary|Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment|The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.|At day 42 after initiation of treatment|From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.|||milligrams per kilogram||Standard Deviation|Mean
2743144|NCT00929669|Secondary|Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.|Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.|12 months||||number of participants|||Number
2743145|NCT00929669|Primary|Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI|MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.|12 months||||participants|||Number
2743146|NCT00929656|Secondary|Motor Activity Log - How Well Change|"Self-Report of How Well paretic UE performed completing 30 functional tasks. Each task is reported on a 0-5 scale with 0 representing Unable to use my paretic hand to perform that task and 5 representing My paretic hand performs that task as well as it did before the stroke. A 5 on each task would be considered normal."|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||Units on a scale||Standard Error|Mean
2743147|NCT00929656|Secondary|Motor Activity Log - Amount of Use Change|"Self-Report Amount of Use of Paretic UE to complete 30 functional tasks. Each task is reported on a 0-5 scale with 0 representing did not use my paretic hand at all for that task and 5 representing I used my paretic hand as much as before the stroke to complete that task. A 5 on each task would be considered normal."|Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||Units on a scale||Standard Error|Mean
2743148|NCT00929656|Secondary|Grip Strength Change|Change in Paretic hand grip strength from pre- to post-intervention. Grip strength measured by hand-held dynamometer. An average of 3 5-second trials was used for analysis.|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||kilograms||Standard Error|Mean
2743413|NCT00928187|Secondary|Number of Patients With WHO Stage 3 and 4 HIV Related Events|patients having a diagnosis of HIV related event classified as stage 3 or 4|between baseline and 48 weeks|ITT|||participants|||Number
2743153|NCT00929643|Primary|Duration of Hospitalization (by Failure of Initial Empiric Treatment)|Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch).|Baseline up to 6 months|FAS; n=number of participants with nonmissing data|||Days||Standard Deviation|Mean
2743154|NCT00929643|Primary|Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy|Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection.|Baseline up to 6 months|FAS; n=number of participants in which failure could be assessed|||Percentage of participants|||Number
2743155|NCT00929643|Primary|Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)||Baseline up to 6 months|FAS|||Percentage of participants|||Number
2743156|NCT00929643|Primary|Duration of Hospitalization|Overall health care resource utilization was analyzed using mean duration of hospitalization.|Baseline up to 6 months|Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.|||Days||Standard Deviation|Mean
2743157|NCT00929578|Secondary|Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.|Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.|1 week|All participants who were enrolled and completed baseline and week 1 were included.|||participants|||Number
2743158|NCT00929578|Secondary|Safety Outcome Measures|adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.|8 weeks|All participants who completed enrollment.|||All Study Participant|||Number
2743159|NCT00929578|Secondary|Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks|Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.|4 weeks|Participants who completed entire trial.|||percentage of baseline pruritus||Standard Deviation|Mean
2743160|NCT00929578|Primary|Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks|Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.|4 weeks|All participants who successfully were enrolled.|||units on a scale||Standard Deviation|Mean
2743161|NCT00929526|Secondary|Number of Subjects With Pregnancies and Pregnancy Outcomes.|Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
2743162|NCT00929526|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
2743163|NCT00929526|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.||During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
2743164|NCT00929526|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.|NOCDs included autoimmune diseases, diabetes mellitus.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
2743165|NCT00929526|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
2743166|NCT00929526|Secondary|HPV-16 and HPV-18 Antibody Titers|Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.|||Titers||95% Confidence Interval|Geometric Mean
2743414|NCT00928187|Primary|Number of Patients With Plasma HIV RNA < 50 Copies/mL||48 weeks|ITT|||participants|||Number
2743167|NCT00929526|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.|Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.|||Subjects|||Number
2743168|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.|"Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between.~HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
2743169|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.|"Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days).~For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
2743170|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.|HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
2743171|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.|"For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
2743172|NCT00929526|Secondary|Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.~HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
2743173|NCT00929526|Secondary|Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.~HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
2743174|NCT00929526|Secondary|Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).~For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
2743175|NCT00929526|Primary|Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).~Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).~For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
2743189|NCT00929357|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.|||mm/h||Standard Deviation|Mean
2743176|NCT00929500|Secondary|Muscle Strength|MAST sessions were held twice a week for 16 weeks. Each exercise session consisted of 10 min of warm-up, 15-30 min of interval aerobic training by cycle ergometer according to the program, 20 min of strength training exercises, and 10 min of cool-down by stretching. The target heart rate (HR) increased progressively from 50% up to 80% of HR reserve by the end of the intervention period.The Karvonen formula ([(HRmax - HRrest)×(0.50 to 0.80)] + HRrest) was used to calculate the target HR. During every training session a new wireless computerized ECG monitoring system was used. After aerobic training, the strength training program was performed. Exercises used body mass as resistance and included squat, step-up-squat, step-up, heel rise, and sit-ups. Dumbbells were used as extra weight (5 or 10% of body weight) during other exercises except for sit-ups. The control group participated in an educational session once a month and kept physical activity diaries during the intervention period.|At baseline and after 4 months of intervention||||W||Standard Deviation|Mean
2743177|NCT00929500|Secondary|Trail Making Test|The Trail Making (TM) test is a measure of shifting attention. Participants are required to sequentially connect a series of numbered circles (Part A), and then to alternate between numbers and letters sequentially (Part B) (e.g., A-1-B-2-C-3..). Any participant who has not completed Part B within the standard 5 minutes (300 seconds) allotted for the task will be considered unable to complete the task. The scores in Part A (TM-A), Part B (TM-B) T scores ( age, education adjusted), and their difference (TM-B -TM-A) were calculated and used to measure executive function, i.e., lower scores indicates better performance.|At baseline and after 4 months of intervention||||T-score||Standard Deviation|Mean
2743178|NCT00929500|Secondary|Cerebral Blood Flow Velocity (BFV)|Cerebral BFV was monitored using Transcranial Doppler Ultrasound.11 The middle cerebral artery was insonated from the temporal window by placing the 2-MegaHertZ (MHz) probe against the skin of the temporal region above the zygomatic arch. The probe was positioned to obtain maximal BFV and was fixed at the desired angle using a 3-dimensional positioning system. Once instrumented, BFV was continuously recorded throughout ten minutes of supine rest and 10-minutes on a table tilted to 80° from the horizontal position (head-up with foot plate support).|At baseline and after 4 months of intervention||||cm/s||Standard Deviation|Mean
2743179|NCT00929500|Primary|Maximal Oxygen Uptake|To obtain peak oxygen uptake (VO2max; ml−1/min−1/kg), a symptom-limited exercise stress test was performed on a cycle ergometer. The test was preceded by a 2-minute warm-up at the intensity of 20 W. The first test load was 20 W, and was increased by 20 W at each 2-minute stage until the participants could no longer continue, i.e., they were unable to maintain pedaling frequency > 40 rpm, they achieved a respiratory exchange ratio of more than 1.0, or clinical criteria for test termination was observed. VO2max was measured and monitored with a breath-by-breath gas exchange system.|At baseline and after 4 months of intervention||||ml/kg/min||Standard Deviation|Mean
2743180|NCT00929474|Primary|Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)|The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.|12 months|The BOOST study is prematurely terminated so there were no meaningful measurement from the study.||||||
2743181|NCT00929383|Secondary|Rate of Restenosis|"The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis >50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis.~The WASID method is a standardized protocol for measuring intracranial arterial stenosis.~[1-(Dstenosis/Dnormal)] x100=% stenosis (where D=vessel diameter)"|12 Months|There were only N=77 patients available for analysis of restenosis at 12 months. This differs from the original N=82 ITT population in that denominator is based on the number of subjects available at 30 day follow up. Five subjects who exited the study at discharge were excluded from the analysis (no stent implanted (4), death (1)).|||participants|||Number
2743182|NCT00929383|Secondary|Cumulative Stroke Rate at 12 Months|The cumulative stroke rate at 12 months (any stroke or neurological death </= 30 days or any ischemic stroke in territory >/= 31 days is 15.9% or 13 events per 82 patients|12 months|(ITT) Intent-to-treat|||participants|||Number
2743183|NCT00929383|Primary|Rate of Recurrent Ischemic Stroke in the Target Territory|The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.|12 Months|(ITT) Intent-to-treat|||participants|||Number
2743184|NCT00929383|Primary|Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)|"Any stroke or neurological death at </= 30 days will be included in the cumulative morbidity and mortality rate.~There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients."|30 days|(ITT) Intent-to-treat|||participants|||Number
2743185|NCT00929383|Primary|Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)|The number of Wingspan Stents successfully deployed across the target lesion.|Peri-procedural|(ITT) Intent-to-treat|||patients w stent implanted|||Number
2743186|NCT00929357|Secondary|Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)|Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (<20 EU) or positive (≥20 up to >60 EU).|Baseline (Day 0) up to 48 months|Evaluable population; N=number of participants with evaluable data for CCP. CCP value as a laboratory diagnostic marker was collected within the complete timeframe and was documented only once; calculation for change in value not applicable.|||participants|||Number
2743187|NCT00929357|Secondary|Number of Participants With Change From Baseline in Rheumatoid Factor (RF)|Rheumatoid Factor measured as a titer and categorized as negative (<1:16 ratio) or positive. A ratio >1:16 indicates a higher level of RF.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for Positive or Negative status for DMARDS and Biologics, respectively.|||participants|||Number
2743188|NCT00929357|Secondary|Change From Baseline in C-reactive Protein (CRP)|C-reactive protein measured as milligrams per liter (mg/l)|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.|||mg/l||Standard Deviation|Mean
2770987|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2743190|NCT00929357|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.|||scores on a scale||Standard Deviation|Mean
2743191|NCT00929357|Secondary|Number of Participants Without Erosions|Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.|Baseline (Day 0) up to 48 months|Evaluable population. Ratingen scores were calculated based on radiographic assessment, but score of 0 (no erosions) was not reported separately; data not summarized.|||participants|||Number
2743192|NCT00929357|Secondary|Number of Participants Without Radiographic Progression|An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.|Baseline (Day 0) up to 48 months|Evaluable population|||participants|||Number
2743193|NCT00929357|Primary|Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression|Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.|Baseline (Day 0) up to 48 months|Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.|||scores on a scale||Standard Deviation|Mean
2743194|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12||||drinks/drinking day||Standard Deviation|Mean
2743195|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12||||drinking days/week||Standard Deviation|Mean
2743196|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12||||drinks/week||Standard Deviation|Mean
2743197|NCT00929331|Secondary|Number of Subjects With Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning up to the end of the study (Day 0 - Day 21)||||subjects|||Number
2743198|NCT00929331|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During a 21-day (Day 0-20) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
2743199|NCT00929331|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
2743200|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
2743201|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius.|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
2743268|NCT00928772|Secondary|Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia|VAS from 0 to 10 with 10 being maximal discomfort percieved|during cataract surgery up to 30 minutes||||units on a scale||Full Range|Mean
2743202|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
2743203|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
2743204|NCT00929331|Primary|Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value|The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
2743205|NCT00929331|Primary|Seroconversion Factors|Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||ratio||95% Confidence Interval|Mean
2743206|NCT00929331|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject who had either a prevaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a four-fold increase in post-vaccination titer. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
2743207|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
2743208|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
2743209|NCT00929331|Primary|GMTs of HI Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2743210|NCT00929331|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2743211|NCT00929305|Primary|Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.|baseline and one day||||units on a scale||Standard Deviation|Mean
2743212|NCT00929305|Secondary|Muscle Trigger Points of the Cervical Spine||one day|||||||
2743213|NCT00929305|Secondary|Range of Motion of the Neck and Shoulders||one day|||||||
2743214|NCT00929305|Primary|The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.|baseline and one day||||participants|||Number
2743215|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2743216|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)|Objective Response was determined by the investigator using RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Pearson-Clopper one-sample method was used for CI.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2743217|NCT00929240|Secondary|Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)|The EORTC QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase.|Baseline, Randomization and Cycles 3, 6, 9 and 12|Maintenance Phase ITT population; n (number) = number of participants analyzed at the specific visit. Only timepoints with more than 10 participants in each treatment arm are presented.|||units on a scale||95% Confidence Interval|Mean
2743218|NCT00929240|Secondary|Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)|Time to Progression was defined as the time from randomization to the first documented disease progression (using investigator assessments of disease progression by RECIST 1.0). PD was defined as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population|||months||95% Confidence Interval|Median
2743219|NCT00929240|Secondary|Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)|PD was defined per RECIST 1.0 as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population|||percentage of participants|||Number
2743220|NCT00929240|Secondary|Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)|Probability of being alive after 1 and 2 years on treatment with 95% CIs was calculated using Kaplan Meier approach with LOGLOG transformation.|Years 1 and 2|Maintenance Phase ITT Population|||percentage of participants||95% Confidence Interval|Number
2743221|NCT00929240|Secondary|Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)|Duration of Overall Survival (OS) was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. Kaplan Meier estimation was used to determine OS.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||months||95% Confidence Interval|Median
2743222|NCT00929240|Secondary|Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)||Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||percentage of participants|||Number
2743223|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||percentage of participants||95% Confidence Interval|Number
2743224|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Progressive disease (PD) was defined as 20% increase in the sum of the longest diameter of target lesions and SD was defined as small changes that do not meet above criteria. Pearson-Clopper one-sample method was used for Confidence intervals (CIs).|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT Population|||percentage of participants||95% Confidence Interval|Number
2743225|NCT00929240|Primary|Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)|PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||months||95% Confidence Interval|Median
2743226|NCT00929240|Primary|Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)|Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population: All randomized participants|||percentage of participants|||Number
2743227|NCT00929201|Secondary|Peak Plasma Concentration (Cmax) of Metformin|Serum samples were used to determine the maximum concentration for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period|||ng/mL||Standard Deviation|Least Squares Mean
2743228|NCT00929201|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin|Serum samples were used to determine the AUC from time 0 to infinity for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period|||μg * hr/mL||Standard Deviation|Least Squares Mean
2743229|NCT00929162|Secondary|Tumour Response Rate|Objective response rate defined as participants with a complete or partial response according to RECIST|While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)|The number of participants for analysis corresponds to patients with measurable disease at study entry|||Participants|||Number
2743230|NCT00929162|Secondary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 2 years|Overall Survival was not analysed as the study was terminated early.||||||
2743231|NCT00929162|Primary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.|Patients were followed for progression up to 2 years||||Months||Inter-Quartile Range|Median
2743232|NCT00929110|Secondary|Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)|The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2743233|NCT00929110|Secondary|"Percentage of Days Able to Perform Usual Daily Activities During the Study (Baseline to Week 52)"|"A day able to perform usual daily activities was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of days able to perform usual daily activities was calculated as the total number of days able to perform usual daily activities over the 52 week treatment period divided by the total number of days where diary recordings were made."|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of days||Standard Error|Least Squares Mean
2743234|NCT00929110|Secondary|"Percentage of Days With no Daytime Symptoms During the Study (Baseline to Week 52)"|"A day with no daytime symptoms was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with no daytime symptoms was calculated as the total number of days with no daytime symptoms over the 52 week treatment period divided by the total number of days where diary recordings were made."|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of days||Standard Error|Least Squares Mean
2743235|NCT00929110|Secondary|"Percentage of Nights With no Nighttime Awakenings During the Study (Baseline to Week 52)"|"A night with no nighttime awakenings was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with 'no nighttime awakenings' was calculated as the total number of nights with no nighttime awakenings over the 52 week treatment period divided by the total number of nights where diary recordings were made."|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of nights||Standard Error|Least Squares Mean
2770988|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2743236|NCT00929110|Secondary|Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of participants|||Number
2743237|NCT00929110|Secondary|Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)|The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Exacerbations per treatment year||95% Confidence Interval|Number
2743238|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743239|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743240|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743241|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|"Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks."|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743242|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743243|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|"Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks."|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743244|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743269|NCT00928772|Primary|Anxiety During Cataract Surgery Under Topical Anesthesia|Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.|during the cataract surgery up to30 minutes||||units on a scale||Full Range|Mean
2743245|NCT00929110|Secondary|Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52|"Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told At the end of the next normal breath out, take a deep breath all the way in; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure."|Day 1, Week 12, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743246|NCT00929110|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743247|NCT00929110|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Puffs||Standard Error|Least Squares Mean
2743248|NCT00929110|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Days||Full Range|Median
2743249|NCT00929110|Secondary|Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52|The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.|Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2743250|NCT00929110|Secondary|Transition Dyspnea Index (TDI) at Week 26|The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.|Week 26|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2743251|NCT00929110|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.|Week 12|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
2743252|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Investigator|Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain|immediate post injection||||units on a scale|Participants|Standard Deviation|Mean
2743253|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Subject|Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).|immediate post-injection||||units on a scale|Participants|Standard Deviation|Mean
2743254|NCT00928954|Primary|Percent Change in Median Eye Speed|Median eye speed during attempted visual fixation by each eye|After 2 weeks of therapy, for both drugs||||Percent change|||Number
2743255|NCT00928954|Primary|Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing||After 2 weeks of therapy, for both drugs||||logMAR|||Number
2743256|NCT00928889|Secondary|Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)|Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. GSA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||Percentage||Standard Deviation|Mean
2743270|NCT00928746|Secondary|Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2743271|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
2743257|NCT00928889|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)|Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. hsCRP was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mg/dL||Standard Deviation|Mean
2743258|NCT00928889|Secondary|Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)|Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. FFA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743259|NCT00928889|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743260|NCT00928889|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. LDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743261|NCT00928889|Secondary|Change From Baseline in Triglycerides at the End of the Study (Week 4)|Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Triglycerides were assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743262|NCT00928889|Secondary|Change From Baseline in Total Cholesterol at the End of the Study (Week 4)|Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Total cholesterol was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743263|NCT00928889|Secondary|Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol*min/L||Standard Deviation|Mean
2743264|NCT00928889|Secondary|Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743265|NCT00928889|Primary|Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
2743266|NCT00928772|Secondary|Heart Rate During Cataract Surgery Under Topical Anesthesia||during cataract surgery up to 30 minutes||||Beats per minute||Full Range|Mean
2743267|NCT00928772|Secondary|Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia||during cataract surgery up to 30 minutes||||mmHg||Full Range|Mean
2743279|NCT00928746|Secondary|Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations based on advancing the actuation indicator to a zero reading or to the next increment and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||95% Confidence Interval|Median
2743280|NCT00928746|Secondary|Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed|Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||95% Confidence Interval|Median
2743281|NCT00928746|Secondary|Actuations Registered by the Actuation Indicator and Read by Site Coordinator||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
2743282|NCT00928746|Secondary|Actuations Based on Advancing the Actuation Indicator|Actuations based on advancing the actuation indicator to a zero reading or to the next increment|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
2743283|NCT00928746|Secondary|Actuations Recorded on Patient Diary||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
2743284|NCT00928746|Primary|Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)|||Count||95% Confidence Interval|Median
2743285|NCT00928746|Primary|Actuations Dispensed|Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)|||Count||Standard Deviation|Median
2743286|NCT00928746|Primary|Actuations Registered by the Actuation Indicator|This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator|21 Days|The primary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
2743287|NCT00928720|Secondary|Functional Status Using the Fibromyalgia Index Questionnaire||Week 8||||units on a scale||Standard Deviation|Mean
2743288|NCT00928720|Secondary|Perceived Stress Using Numeric Rating Scale||Week 8||||units on a scale||Standard Deviation|Mean
2743289|NCT00928720|Secondary|Depression Using the CES-D||Week 8||||units on a scale||Standard Deviation|Mean
2743290|NCT00928720|Secondary|General Sleep Disturbance Scale||Week 8||||units on a scale||Standard Deviation|Mean
2743291|NCT00928720|Secondary|Fatigue Using Lee's Fatigue Scale|A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale|Week 8||||units on a scale||Standard Deviation|Mean
2743292|NCT00928720|Primary|Pain Intensity Using Numeric Rating Scale|A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity|week 8||||units on a scale||Standard Deviation|Mean
2743293|NCT00928707|Secondary|Percentage of Patients With a Reduction of the Fraction of JAK2V617F Positive Clonogenic Progenitor by Timepoints|"JAK2V617F genotyping and quantification were performed on gradient-separated mononuclear cells during the pre-treatment evaluations (baseline), halfway through the study (12th weeks) and at the end of the study period (24th weeks).~Baseline: n=22 (50 mg od); 22 (50 mg bid) Week 12: n=20 (50 mg od); 19 (50 mg bid) Week 24: n=18 (50 mg od); 18 (50 mg bid)"|Baseline, at weeks 12 and 24|Safety/Intention-to-treat (ITT) population, which included all randomized subjects who received at least one dose of study medication.|||percentage of participants|||Number
2743294|NCT00928707|Secondary|Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR|To determine JAK2V617F mutational status, a quantitative RT-PCR (Real Time-Polymerase Chain Reaction) is executed on peripheral blood granulocyte and haematopoietic colonies (with and without hepatocyte growth factors - HGFs).|"At weeks 12, 24, at drop out visit and at End of Study (EOS). EOS stays for 7 days after last drug intake if patient is withdrawn from the study before week 24."|Safety/Intention-to-treat (ITT) population, which included all randomized subjects who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
2743295|NCT00928707|Secondary|Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12.|"Haematological response after a 50 mg increase of the initial Givinostat dose in non-responder patients at the time when the primary endpoint was assessed (week 12).~Complete response:~HCT< 45% without phlebotomy, and~platelets ≤ 400 x109/L, and~WBC ≤ 10 x 109/L, and~no splenomegaly, and~no disease related systemic symptoms (microvascular disturbances, pruritus, headache);~Partial response:~HCT < 45% without phlebotomy, or~fulfilment of at least 3 of the other above mentioned criteria;~No response:~any response that did not satisfy the criteria set for partial response."|At week 24 of treatment|Safety/Intention to treat (ITT) population included all randomized subjects who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2743296|NCT00928707|Primary|Percentage of Patients With Overall Haematological Response at Week 12.|The percentage of patients with overall (complete or partial) response at week 12 were assessed. · Complete response: 1. HCT (Hematocrit) < 45% without phlebotomy, and 2. platelets ≤ 400 x109/L, and 3. WBC (white blood cell) ≤ 10 x 109/L, and 4. no splenomegaly, and 5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache); · Partial response: 1. HCT < 45% without phlebotomy, or 2. fulfilment of at least 3 of the other above mentioned criteria; · No response: any response that did not satisfy the criteria set for partial response.|At week 12 of treatment|Safety/ITT population: included all randomized subjects who received at least one dose of study medication.|||percentage of particpants||95% Confidence Interval|Number
2743297|NCT00928694|Primary|Maximum Plasma Concentration (Cmax) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45|||μg/mL||Standard Deviation|Least Squares Mean
2743298|NCT00928694|Primary|Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45|||μg·hr/mL||Standard Deviation|Least Squares Mean
2743300|NCT00928668|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|5 days|The safety set included all patients who received any study medication.|||percentage of participants|||Number
2743301|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours|32 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
2743302|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours|8 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
2743303|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours|4 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
2743304|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes|30 minutes post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
2743305|NCT00928668|Primary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours|24 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
2743306|NCT00928642|Secondary|To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.|The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.|Until disease progression|||||||
2743307|NCT00928642|Secondary|To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)|"Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.~Repsonse rate was the sum of Complete Repsonse and Partial Response."|until disease progression or unacceptable toxicity|All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals|||participants|||Number
2743308|NCT00928642|Secondary|To Determine the Distribution of the Overall Survival|All subjects were followed after treatment was complete to assess overall survival.|Until death||||months||Full Range|Median
2743309|NCT00928642|Secondary|Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.|"Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as complete response, partial response, stable disease, and progressive disease after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.~the measurement reported is the number of patients who met the criteria for partial response."|Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified|All subjects who underwent treatment and participated in the study were analysed|||participants|||Number
2743310|NCT00928642|Primary|To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria|Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria|Until disease progression or unacceptable toxicity||||participants|||Number
2743311|NCT00928642|Primary|The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.|Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.|Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.|of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment|||participants|||Number
2743312|NCT00928512|Secondary|Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16|Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||mm/hr||Standard Error|Least Squares Mean
2743462|NCT00927992|Secondary|Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation||Post liver transplantation up to Month 3|Data was not analyzed as only hemophiliac participants were enrolled in the study.||||||
2743313|NCT00928512|Secondary|Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)|Blood for this assessment was obtained at the visits in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.Since the results of this test may have unblinded study personnel, results from the central lab were provided for screening and baseline only. The hsCRP results from samples collected during the treatment period were revealed only after final database lock.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||mg/L||Standard Error|Least Squares Mean
2743314|NCT00928512|Secondary|Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16|HAQ© was used to assess physical ability and functional status of patients as well as quality of life at the visits in these 8 categories assessed by the Disability Index: dressing & grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Patients report amount of difficulty they have in performing 2 or 3 specific activities. There are 4 possible responses (0, 1, 2, 3) for these questions which include types of assistance, if any; the participant uses for his/her usual activities: 0: without any difficulty- No assistance is needed; 1: with some difficulty - A special device is used by the patient in his/her usual activities; 2: with much difficulty - The patient usually needs help from another person. 3: Unable to do - the patient usually needs both a special device and help from another person. Scores of 0 - 1 are generally considered to represent mild to moderate difficulty, 1-2 moderate to severe disability, and 2 -3 severe to very severe disability.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale||Standard Error|Least Squares Mean
2743315|NCT00928512|Secondary|Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16|"The physician's global assessment of disease activity was performed at the visits usingon a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||VAS in mm||Standard Error|Least Squares Mean
2743316|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16|"The patient's global assessment of disease activity was performed at the visits on a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||VAS in mm||Standard Error|Least Squares Mean
2743317|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16|"The patient's assessment of pain was performed at all visits using 100 mm visual analog scale (VAS) ranging from no pain to unbearable pain after the question Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||VAS in mm||Standard Error|Least Squares Mean
2743318|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16|The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28*(t/T)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||tender joints||Standard Error|Least Squares Mean
2743319|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale||Standard Error|Least Squares Mean
2743552|NCT00927563|Secondary|Gambling Symptom Assessment Scale (G-SAS)|Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.|Visit 5 (final visit)||||units on a scale||Standard Deviation|Mean
2743320|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16|Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28*(s/S)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||swollen joints||Standard Error|Least Squares Mean
2743321|NCT00928512|Secondary|Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16|Only values that were above normal range (20 units) were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Units||Standard Deviation|Mean
2743322|NCT00928512|Secondary|Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16|Only values that were above normal range (12 U/mL) were were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||U/mL||Standard Deviation|Mean
2743323|NCT00928512|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16|The distribution of EULAR response criteria was according to DAS28-CRP at Week 16. EULAR response criteria are based on DAS28-CRP status in combination with DAS28-CRP improvements. The EULAR response criteria are as follows: Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement >1.2 corresponds to 'good response'; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement between 0.6 to 1.2, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement >1.2 or from 0.6 to 1.2, or WeeK 16 DAS28-CRP >5.1 with DAS28-CRP improvement >1.2 correspond to 'moderate response; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP >5.1 with DAS28-CRP improvement between 0.6 to 1.2 or <0.6 correspond to 'no response'.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Percentage of participants|||Number
2743324|NCT00928512|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16|The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeThe scale score was computed by summing the item scores, after reversing those items that were worded in the negative direction. When there were missing item scores, the subscale score was computed by summing the non-missing item scores, multiplying by 13 (the total number of items in the scale) and dividing by the number of non-missing items. The latter rule applied only when at least half of the items (seven or more) were non-missing. FACIT-Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale-change from baseline||Standard Deviation|Mean
2743325|NCT00928512|Secondary|Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)|The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) which can be aggregated to derive a physical-component summary score and a mental-component score. Scores are normally determined with the use of norm-based methods which standardize scores based on an assessment of the general U.S. population free of chronic conditions. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with the higher scores indicative of better health.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale-change from baseline||Standard Deviation|Mean
2743326|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission. The DAS28-CRP was derived from swollen joint count, tender joint count, hsCRP and patient's global assessment of disease activity.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale||Standard Error|Least Squares Mean
2770989|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2743327|NCT00928512|Secondary|Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16|A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if he/she had as least a 20%, 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assessed disability and acute phase rectant or Erythrocyte sedimentation rate (ESR).|at Weeks2, 4, 8, 12, 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Participants|||Number
2743328|NCT00928512|Secondary|Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16|A participant was considered as improved according to the ACR50 or ACR70 criteria if he/she had at least a 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient self-assessed disability (Health Assessment Questionnaire [HAQ©] score) and Acute phase reactant (C-reactive protein [hsCRP]/ESR). Participants were defined as ACR50/70 responders at a given post-randomization visit if they satisfied the ACR50/70 criteria, respectively. Participants were considered ACR50/70 nonresponders if they failed the ACR50/70 criteria respectively. Participants who prematurely discontinued from study due to insufficient therapeutic effect were also considered nonresponders.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Participants|||Number
2743329|NCT00928512|Primary|Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks|A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire [HAQ©] score)and acute phase rectant (C-reactive protein [hsCRP]/ESR).|16cweeks|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Participants|||Number
2743330|NCT00928486|Secondary|Kaplan-Meier Estimates of Duration of Response (DoR)|Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia >11.5mg/dL|From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders|||weeks||95% Confidence Interval|Median
2743331|NCT00928486|Secondary|Myeloma Response Rate|Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.|From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria|||percentage of participants|||Number
2743332|NCT00928486|Primary|Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)|A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks|Safety population included all 25 participants who received at least one dose of study drug.|||participants|||Number
2743333|NCT00928434|Secondary|Percent Change From Baseline in Serum Testosterone Levels|Percent change from Baseline in serum testosterone levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percent change||Standard Deviation|Mean
2743334|NCT00928434|Secondary|Absolute Change From Baseline in Serum Testosterone Levels|Absolute Change From Baseline in Serum Testosterone Levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||ng/mL||Standard Deviation|Mean
2743335|NCT00928434|Secondary|Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level|The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Days||95% Confidence Interval|Median
2743336|NCT00928434|Secondary|Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group|The time to testosterone >0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Days||95% Confidence Interval|Median
2743337|NCT00928434|Secondary|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.|At 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percentage of patients||95% Confidence Interval|Number
2743338|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score|The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743339|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743340|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743341|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743342|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Erection|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743343|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743344|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score|The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743345|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743346|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743347|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743348|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743349|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
2743350|NCT00928434|Secondary|Percent Change From Baseline in Serum PSA Levels|Percent change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percent change||Standard Deviation|Mean
2743590|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 12 Endpoint|OC is a measure of osteoblast function.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months OC measurements.|||microgram/liter (µg/L)||Inter-Quartile Range|Median
2743351|NCT00928434|Secondary|Absolute Change From Baseline in Serum PSA Levels|Absolute change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||ng/mL||Standard Deviation|Mean
2743352|NCT00928434|Primary|Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL|Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.|At 14 month|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percentage of patients||95% Confidence Interval|Number
2743353|NCT00928421|Primary|Responders to Treatment, Assessed by Duplex Ultrasound|Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.|8 weeks||||participants|||Number
2743354|NCT00928408|Primary|Reason for Prescribing Cinacalcet||Initiation|Full Analysis Set|||Participants|||Number
2743355|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data|||Percent change||Inter-Quartile Range|Median
2743356|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data|||Percent change||Inter-Quartile Range|Median
2743357|NCT00928408|Primary|Change From Baseline to Month 12 in Albumin-corrected Serum Calcium||Baseline to Month 12|Full Analysis Set - Participants with Observed Data|||mmol/L||Standard Error|Mean
2743358|NCT00928408|Primary|Change From Baseline to Month 6 in Albumin-corrected Serum Calcium||Baseline to Month 6|Full Analysis Set - Participants with Observed Data|||mmol/L||Standard Error|Mean
2743359|NCT00928408|Primary|Change From Baseline to Month 3 in Albumin-corrected Serum Calcium||Baseline to Month 3|Full Analysis Set - Participants with Observed Data|||mmol/L||Standard Error|Mean
2743360|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12||Month 12|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743361|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6||Month 6|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743362|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3||Month 3|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743363|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12|Baseline is pre-cinacalcet.|Month 12|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743364|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6|Baseline is pre-cinacalcet.|Month 6|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743365|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3|Baseline is pre-cinacalcet.|Month 3|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743366|NCT00928408|Primary|Duration of Exposure to Cinacalcet|Time from first dose to last non-zero dose on study|12 months|Full Analysis Set|||Days||Inter-Quartile Range|Median
2743367|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation||>6 months after initiation|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743368|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation||>3 to 6 months after initiation|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743369|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation||Initiation to Month 3|Full Analysis Set|||Participants|||Number
2743370|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at end of treatment|Up to Month 12|Full Analysis Set|||Participants|||Number
2743371|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 12|Month 12|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743372|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 6|Month 6|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743373|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 3|Month 3|Full Analysis Set - Participants with Observed Data|||Participants|||Number
2743374|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at initiation of treatment|Initiation of treatment|Full Analysis Set|||Participants|||Number
2743375|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at end of treatment (last dose received)|Up to Month 12|Full Analysis Set|||mg/day||95% Confidence Interval|Mean
2743376|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 12|Month 12|Full Analysis Set - Participants with Observed Data|||mg/day||95% Confidence Interval|Mean
2743377|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 6|Month 6|Full Analysis Set - Participants with Observed Data|||mg/day||95% Confidence Interval|Mean
2743378|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 3|Month 3|Full Analysis Set - Participants with Observed Data|||mg/day||95% Confidence Interval|Mean
2743379|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at initiation of treatment|Initiation of treatment|Full Analysis Set|||mg/day||95% Confidence Interval|Mean
2743380|NCT00928395|Secondary|Change in Voiding Diary Parameters.||every three months for 36 months|||||||
2743381|NCT00928395|Secondary|Change in OAB-q and SF-36 Questionnaires.||every three months for 36 months|||||||
2743382|NCT00928395|Secondary|GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.||every three months for 36 months|||||||
2743383|NCT00928395|Primary|"Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline"|"The GRA asked patients, Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now? and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse)."|36 months total||||Proportion of Patients||95% Confidence Interval|Number
2743384|NCT00928304|Secondary|Consistency Between Visual and Quantitative Efficacy|For a comparison of the results of the visual assessment with the quantitative assessment, descriptive Standardized Uptake Value Ratio (SUVR) statistics were computed separately for DS subjects with an abnormal/normal majority read of the PET scan (DS-PET+/DS-PET-). The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min||||SUVR||Standard Deviation|Mean
2743385|NCT00928304|Secondary|Quantitative Parameters Standard Uptake Value Ratio|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min p.i.|All Down Syndrome subjects and healthy volunteers enrolled in the study were included in this analysis|||SUVR||Standard Deviation|Mean
2743386|NCT00928304|Secondary|Sensitivity Results in the Down Syndrome Age Subgroups|The majority read sensitivity (percentage of DS subjects positive for cerebral beta-amyloid by majority read) was computed for the group of DS subjects with age equal to or below the median age (DS-young) and for DS subjects with age above the median age (DS-old). The median age was 46 yrs, with 3 subjects being exactly 46 yrs old. As defined, these subjects were assigned to the DS-young group.|100 - 120 min|All Down Syndrome subjects (n=39) were analyzed for this outcome.|||percentage of subjects||95% Confidence Interval|Number
2743387|NCT00928304|Primary|Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome|The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.|100-120 min|All subjects in the down syndrome population and healthy volunteers were included in this analysis.|||percentage of subjects||95% Confidence Interval|Number
2743388|NCT00928252|Primary|Proportional Hazards Regression Analysis of Time to PSA Progression|PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.|Up to 15 week post-chemotherapy|Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response.|||Hazard Ratio||95% Confidence Interval|Number
2743389|NCT00928252|Primary|Time to PSA Progression|Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.|2 years||||days||Standard Error|Mean
2743390|NCT00928252|Primary|Metabolically Active Tumor Volume (MATV) Response|Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT|21 to 98 days||||Participants|||Count of Participants
2743391|NCT00928226|Secondary|Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20|"Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20), a survey of 20 questions with the following responses / numerical values.~Not at all~A Little~Quite a Bit~Very Much Response range is 20 to 80, normalized to a 0 to 100 scale. Lower values indicate little effect of disease, and higher values indicate greater effect. The outcome is expressed as the median value with full range, by radiotherapy dose cohort and tumor size."|6 months|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 6-month European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20) health-related quality of life (HR-QoL) data are included.|||score on a scale||Full Range|Median
2743392|NCT00928226|Secondary|Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30|"Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) survey, a survey of 28 questions with the following responses / numerical values.~Not at all~A Little~Quite a Bit~Very Much Response range is 28 to 112, normalized to a 100 point scale. Lower values indicate little effect of disease, and higher values indicate greater effect. The outcome is expressed as the median value with full range, by radiotherapy dose cohort and tumor size."|6 months|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants providing 6-month European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) health-related quality of life (HR-QoL) data are included.|||score on a scale||Full Range|Median
2743393|NCT00928226|Secondary|Overall Survival (OS)|Overall survival (OS) is assessed as remaining alive 3 years after stereotactic radiosurgery (SRS) therapy. The outcome is expressed as the number of participants alive 3 years after SRS, by radiotherapy dose cohort and tumor size, a number without dispersion.|3 years|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS).|||Participants|||Count of Participants
2744122|NCT00923845|Secondary|Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells|Reduction in cluster of differentiation 8 (CD8)+ T cells [change in median values and (range of values)].|Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)||||cells/µL||Full Range|Median
2743394|NCT00928226|Secondary|Adverse Effects More Than 30 Days up to 1 Year|Long-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring more 30 days but within 12 months of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion.|after 30 days and up to 1 year|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants surviving more than 30 days are included.|||adverse events|||Number
2743395|NCT00928226|Secondary|Adverse Effects Within 30 Days|Short-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring within 30 days of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion.|30 days|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS).|||adverse events|||Number
2743396|NCT00928226|Secondary|Distant Intra-cranial Disease Control|Distant treatment failure (failure to achieve or maintain disease control) is defined as the radiographic appearance of a new or enhancing lesion more than 5 mm from the radiosurgical target volume. The outcome is expressed as the number of participants who have distant treatment failure after radiotherapy dose cohort and tumor size, a number without dispersion.|12 months|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 12-month disease status data are included.|||participants|||Number
2743397|NCT00928226|Secondary|Local Disease Control|"Local disease control (treatment response) was assessed on the basis of tumor size before and 12 months after treatment. Treatment response was based on the following criteria. Tumor area is determined as the product of 2 measurements of lesion diameter.~Complete response (CR): The tumor is no longer seen within the radiosurgical target volume~Partial response (PR): Decrease of > 50% in tumor area~Minor response (MR): Decrease of < 50% in tumor area~Stable disease (SD): The scan shows no change.~Progression (P): A > 25% increase in tumor area, or any new lesion within the radiosurgical target volume.~Local control is defined as as any treatment response other than progression. The outcome is as the number of participants that did not progress, by radiotherapy dose cohort and tumor size, a number without dispersion."|12 months|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 12-month treatment response data are included.|||Participants|||Count of Participants
2743398|NCT00928226|Primary|Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)|"The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as.~5 = Death~4 = Serious neurologic impairment such as paralysis, coma, or seizures > 3/week~3 = Neurologic findings requiring hospitalization~2 = Neurologic findings present sufficient to require attendant care~1 = Fully functional status (ie, able to work) with minor neurologic findings; no medication needed~0 = No Change~The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD."|60 days|There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS).|||Dose-limited toxicity (DLT) events|||Number
2743399|NCT00928200|Secondary|Asparaginase Activity|Activity levels assessed from PK sampling|PK samples to be collected Pre-Tx, and and Erwinase Doses 3, 6 and 9 and Day 29|Study closed early due to lack of accrual and insufficient data were collected to perform this analysis.||||||
2743400|NCT00928200|Secondary|Response Rate and Minimum Residual Disease|Disease response evaluated by examination and labs. MRD evaluated from marrow samples.|After completion of treatment course|Study closed early due to lack of accrual, and insufficient data were collected for performing this analysis.||||||
2743401|NCT00928200|Primary|Occurrence of a Dose-Limiting Toxicity|The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy.|Beginning with the first dose of investigational product until 30 days following the last dose of Erwinase||||Participants|||Count of Participants
2743402|NCT00928187|Secondary|Number of Patients With HIV Plasma Viral Load < 200 Copies/ml|number of patients having a plasma viral load below 200 copies/ml at week 24|Week 24|ITT|||Participants|||Count of Participants
2743403|NCT00928187|Secondary|Number of Patients With HIV Plasma Viral Load < 50 Copies/ml|Snapshot of patients with HIV viral load less then 50 copies/ml at week 24|Week 24|ITT|||Participants|||Count of Participants
2743404|NCT00928187|Secondary|Development of Metabolic Syndrome|number of patients developing metabolic syndrome over a period of 48 weeks|from baseline to week 48|population with data available|||Participants|||Count of Participants
2743405|NCT00928187|Secondary|Number of Patients With Resistance Mutations|number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml)|between W12 and W48|patients who failed second line (2 HIV RNA measure above 1000 copies/ml)|||participants|||Number
2743406|NCT00928187|Secondary|Adherence|number of patients in different categories of adherence as measured by questionnaire|between baseline and W48|patients with data available|||participants|||Number
2743407|NCT00928187|Secondary|Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)|evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value|between baseline and W48|ITT|||participants|||Number
2743408|NCT00928187|Secondary|Tolerance: Neuropathies (Grade 1 to 4)|any symptom of peripheral neuropathy|between baseline and W48|ITT|||participants|||Number
2743409|NCT00928187|Secondary|Tolerance: Gastrointestinal Complains|Gastrointestinal complaints (grade 1 to 4) between baseline and W48.|between baseline and 48 weeks|ITT|||participants|||Number
2743410|NCT00928187|Secondary|Number of Patients Discontinuing Study Treatment|number of patients discounting treatment because of adverse events|between baseline and W48|ITT|||participants|||Number
2743411|NCT00928187|Secondary|Gain in CD4 Cells Between Baseline and W48|median gain in circulating CD4 cells between baseline and W48|between baseline and 48 weeks|ITT with data available|||cell/mm3||Inter-Quartile Range|Median
2743415|NCT00928174|Primary|Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT|The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.|Concurrent with PET Procedure|Outcome Measure Data Table reflects data from the 22 subjects completing the current study.|||%PET-positive cases in a given PSA range|||Number
2743416|NCT00928083|Secondary|OZ439 Rac|"Accumulation index is the ratio of drug exposure observed during a dosing interval at steady-state divided by drug exposure after a single first dose, as described by the following equations:~Accumulation index (Rac) = AUC0-(Day 3)/ AUC0-(Day 1)"|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population received multiple dosing only. This PK parameter is not applicable in a single dose setting.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2743417|NCT00928083|Secondary|OZ439 t1/2|Apparent terminal half-life (t1/2)|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2743418|NCT00928083|Secondary|OZ439 Tmax|Time to maximum observed plasma drug concentration of OZ439|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||hours||Full Range|Median
2743419|NCT00928083|Secondary|OZ439 Cmax|Maximum observed plasma drug concentration (Cmax).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2743420|NCT00928083|Secondary|OZ439 AUC0-∝|Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
2743421|NCT00928083|Secondary|OZ439 AUC0-t|Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
2743422|NCT00928083|Primary|Adverse Events|Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.|From screening and at 10 (+/-2) days after last dose of study medication||||participants|||Number
2743423|NCT00928070|Secondary|Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12|PVR volume is defined as volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||mL||Standard Deviation|Mean
2743424|NCT00928070|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline|Screening, Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2743425|NCT00928070|Secondary|Mini Mental State Examination (MMSE)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.|Screening|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2743426|NCT00928070|Secondary|Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response|"Participant's response to question, overall, how satisfied are you with your OAB medication? was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into satisfied, and 4 and 5 were combined into dissatisfied."|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.|||percentage of participants|||Number
2743427|NCT00928070|Secondary|Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control|OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.|||units on a scale||Standard Deviation|Mean
2743436|NCT00928070|Secondary|Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2744123|NCT00923845|Secondary|Immune Depletion in Cluster of Differentiation 4 (CD4) Cells|Reduction in cluster of differentiation 4 (CD4)+ T cells [change in median values and (range of values)].|Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)||||Cells/µL||Full Range|Median
2743428|NCT00928070|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4, 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. LOCF method was used to impute Week 12 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.|||units on a scale||Standard Error|Least Squares Mean
2743429|NCT00928070|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.|||units on a scale||Standard Deviation|Mean
2743430|NCT00928070|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.|||units on a scale||Standard Error|Least Squares Mean
2743431|NCT00928070|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.|||units on a scale||Standard Deviation|Mean
2743432|NCT00928070|Secondary|Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.|Screening, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||percentage of participants|||Number
2743433|NCT00928070|Secondary|Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12|Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'n' is signifying those participants of the population subsets who were evaluated for this measure at the time point for each group respectively.|||undergarments||Standard Deviation|Mean
2743434|NCT00928070|Secondary|Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2743435|NCT00928070|Secondary|Frequency-Urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2743437|NCT00928070|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
2743438|NCT00928070|Secondary|Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
2743439|NCT00928070|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2743440|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
2743441|NCT00928070|Secondary|Mean Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
2743442|NCT00928070|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2743443|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Error|Least Squares Mean
2743444|NCT00928070|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Deviation|Mean
2743445|NCT00928070|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2743456|NCT00928018|Secondary|To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied.||2 years|Given the small number of patients within each group, we considered indolent histologies (indolent B-cell NHL, CLL and HL) together in one group (indolent group), and aggressive histologies (aggressive B-cell NHL, MCL, and T-cell NHL) in another (aggressive group).|||percentage of participants|||Number
2743446|NCT00928070|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.|||episodes per 24 hours||Standard Error|Least Squares Mean
2743447|NCT00928070|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
2743448|NCT00928070|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS) population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
2743449|NCT00928057|Other Pre-specified|Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size|If insulin leakage from the injection site was observed, subjects rated the size of the leakage droplet based on a visual scale provided in their diaries. Scores of 1+, 2+, 3+, and 4+ correspond to droplet sizes of 1, 10, 20 and 50 ul, respectively. Droplets larger than those shown on the scale were scored as 5+. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks|The number of participants shown is the number of subjects that reported at least one event of leakage (see previous data table). The number of reported leakage events is presented for each droplet size category. No data were collected if there was no leakage.|||number of events|||Number
2743450|NCT00928057|Secondary|Relative Injection Pain Score Assessed by Subject|"After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with as painful, and at the extreme ends with much less painful (-75mm) and much more painful (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference."|Visit 4: 18-24 days after starting 2nd pen needle|Of the 167 subjects that completed the study, 137 subjects had within-window VAS pain scores for Visit 4 and were included in this analysis. Per the protocol, the allowable visit window was 18-24 days from Visit 3, when the subject switched from the 1st to 2nd assigned pen needle.|||mm||Standard Error|Mean
2743451|NCT00928057|Other Pre-specified|Percentage of Subjects With at Least One Leakage Event|After each insulin injection with a study pen needle, subjects recorded in their study diary if they observed insulin leakage from the injection site. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks||||percent of subjects|||Number
2743452|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hyperglycemic Events|Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.|||participants|||Number
2743453|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hypoglycemic Events|Severe Unexplained Hypoglycemia is defined as an event in which the subject's blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.|||participants|||Number
2743454|NCT00928057|Secondary|Percent Absolute Change in Fructosamine, by Dose Group|"Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:~%|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|"4 of the 167 completed subjects were excluded for out of window fructosamine samples (3), or lab error with a sample (1).~For 4 mm/8 mm: this includes 45 subjects in the Low Dose insulin group and 35 in the Regular Dose group. For 4 mm/5 mm: this includes 47 subjects in the Low Dose insulin group and 36 in the Regular Dose group."|||Percent absolute change||95% Confidence Interval|Mean
2743455|NCT00928057|Primary|Percent (%) Absolute Change in Fructosamine|"Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:~Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|167 subjects completed the study. 163 of the 167 completed subjects were included in this analysis. Four (4) of 167 were excluded due to out of window fructosamine samples (3), or laboratory error with fructosamine sample (1).|||Percent absolute change||95% Confidence Interval|Mean
2743463|NCT00927992|Secondary|Dose of Exogenous Clotting Factors Used During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.|||International Unit/kilogram (IU/kg)||Standard Deviation|Mean
2743464|NCT00927992|Secondary|Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
2743465|NCT00927992|Primary|Number of Participants Who Survived After Liver Transplantation|Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
2743466|NCT00927992|Primary|Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation|Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
2743467|NCT00927992|Primary|Number of Participants With Acute Rejection of Liver Transplant|Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
2743468|NCT00927992|Primary|Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation|Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
2743469|NCT00927953|Secondary|Time to a >= 1 Point Reduction in the Modified Rankin Scale Score||Study Day 2, 7, 14, 28, and 120|Intention to treat (ITT)|||Days||95% Confidence Interval|Median
2743470|NCT00927953|Secondary|Mean Modified Rankin Scale Scores|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead."|Study Day 0, 2, 7, 14, 28, and 120||||units on a scale||Standard Deviation|Mean
2743471|NCT00927953|Secondary|The Number of Participants With a Favorable Neurologic Outcome|"Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead."|Study Day 2, 7, 14, 28, and 120||||participants|||Number
2743472|NCT00927953|Primary|The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event|Includes adverse events considered possibly, probably, or definitely related to study drug|120 days|Intention to treat (ITT)|||participants|||Number
2743473|NCT00927953|Primary|The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead"|Study Day 2, 7, 14, 28, and 120|All randomized participants with confirmed West Nile virus infection|||participants|||Number
2743474|NCT00927940|Secondary|Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)||8 months|||||||
2743475|NCT00927940|Secondary|Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis||12 months|||||||
2743476|NCT00927940|Secondary|Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)|Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.|12 months|ITT population|||percentage of participants with TLF|||Number
2743477|NCT00927940|Primary|In-stent Late Lumen Loss (LLL)|The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD|Post procedure, 8 Months|Actually a patient was excluded from this analysis because of death before 30 days follow up.|||mm||Standard Deviation|Mean
2743478|NCT00927927|Secondary|Area Under the Concentration-time Curve (AUC)|Systemic exposure to NNC0142-0002.|Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification.|||microgram×h/mL||Geometric Coefficient of Variation|Geometric Mean
2743524|NCT00927784|Secondary|Assessment of LVAD Wean|"The secondary endpoints assessed during the LVAD wean include echocardiographic assessments, 6 minute walk, ability to tolerate wean from LVAD support, duration of ability to tolerate wean from LVAD support, and neuronal function.~Measured at 60 days, 90 days, and every 60 days thereafter following LVAD implantation until heart transplantation or 12 months, whichever comes first"|up to 12 months|data not collected||||||
2743479|NCT00927927|Primary|Frequency of Adverse Events|Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.|Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.|||events|||Number
2743480|NCT00927901|Secondary|Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2743481|NCT00927901|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.|||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
2743482|NCT00927901|Secondary|Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period|Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs > 0) was included to calculate endpoint.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Percentage of participants|||Number
2743483|NCT00927901|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.|Day 1 and Day 7|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Hours||90% Confidence Interval|Median
2743484|NCT00927901|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.|Baseline to Day 1|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||90% Confidence Interval|Least Squares Mean
2743485|NCT00927901|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||90% Confidence Interval|Least Squares Mean
2743486|NCT00927888|Secondary|SNOT-20 Surgical Outcome Score|"This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units).~ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41-47"|1-day|Entire study population included.|||units on a scale|Participants|Standard Deviation|Mean
2743487|NCT00927888|Primary|Postoperative Pain Assessed on Standard VAS Scale|Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.|VAS Pain Score at 7 days|Entire population of both groups.|||units on a scale|Participants|Standard Deviation|Mean
2743488|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 in the Pharmacogenetic (PG)-Guided Dosing Arms and the Parallel Control Arm|What is reported is the percent of patients with an INR ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.|||percent||Standard Deviation|Mean
2743489|NCT00927862|Primary|The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls|The percent of time in therapeutic INR range for the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) guided patients and parallel controls. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.|||percent||95% Confidence Interval|Mean
2743490|NCT00927862|Primary|The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms.|The percent of time in therapeutic INR range for the standard and modified pharmacogenetic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.|||percent||95% Confidence Interval|Mean
2743491|NCT00927862|Primary|The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls|The percent of out of range (OOR) INRs in the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) and parallel controls. A 10% margin outside of the target INR range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with OOR INRs at 1 month.|1 month (from day 3 to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls|||percent||95% Confidence Interval|Mean
2743492|NCT00927862|Secondary|Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls|Prediction of a stable maintenance dose (within 1 mg/day) among the pharmacogenetic (PG)-guided dosing and the parallel control group. For the parallel control group, an empiric starting dose of 5 mg/day was assumed. What is reported is the percent of patients who had their maintenance dose predicted as described above.|3 months (from baseline to 3 months or until stable dosing is achieved, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) and had a stable maintenance dose that could be determined were compared to parallel controls|||percent|||Number
2743493|NCT00927862|Secondary|The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls.|What is reported is the mean number of INRs measured/drawn among the patients in each arm.|1-3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls|||INRs||Standard Deviation|Mean
2743494|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm.|What is reported is the percent of patients with INRs ≥4 or ≤1.5 or having experienced a serious adverse event (SAE) at the end of follow-up.|3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|All patients receiving at least 1 dose of warfarin were included in safety analyses until 1 week after the last warfarin dose|||percent|||Number
2743495|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm|The percent of INRs ≥4 or ≤1.5 for the pharmacogenetic (modified IWPC warfarin algorithm and the standard IWPC warfarin) algorithms. What is reported is the percent of patients with INRs ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|All consented, randomized patients who were successfully genotyped and received at least 1 dose of warfarin with at least 1 postdose INR.|||percent||Standard Deviation|Mean
2743496|NCT00927862|Primary|The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms.|The percent of out of range (OOR) international normalized prothrombin time ratio (INRs) in the standard and modified pharmacogentic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin outside of the target range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with an OOR INR at 1 month.|1 month (from day 3 to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.|||percent||95% Confidence Interval|Mean
2743497|NCT00927849|Primary|Relieve of Anal Pain|using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 ( severe pain)|one year after the procedure||||score in scale||Standard Deviation|Mean
2743498|NCT00927849|Primary|Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal|effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery|one year|||||||
2743499|NCT00927823|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected|Response analysis set included all participants who started treatment and had an adequate baseline tumor assessment.|||participants|||Number
2743500|NCT00927823|Secondary|Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue|Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene mutation, PIK3CA gene amplification, and phosphatase and tensin homolog (PTEN) protein deficiency status by immunohistochemistry.|Baseline; 4 hours post-dose on C1D21|Baseline tumor tissue biomarker analysis set: all enrolled participants who started treatment, had baseline tumor tissues (archived paraffin block/unstained slides/fresh tumor tissue) analyzed for at least 1 of biomarkers. N (number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at specified time point.|||participants|||Number
2743501|NCT00927823|Secondary|Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21|Hair follicle biopsy samples analysis included assessment of status of proteins indicative of PI3K/mTOR related pathways signaling status and cell cycle status. The analytes measured were phosphorylated AKT S473, AKT T308, KI67, STAT3 (Y705) and proline-rich Akt substrate of 40 kilodaltons at Thr246 (PRAS40 T246). The method of analysis was reverse phase microarray (RPMA). The signal for each biomarker expressed as normalized fluorescence intensity (NFI) was normalized by their respective total protein concentration. This normalization was performed by dividing the biomarker NFI by total protein concentration (mg/mL) of the sample printed to give total protein normalized fluorescence unit (NFU). All clinical sample test results are reported in NFU.|Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21|Hair follicle analysis set included participants with hair follicles collected and analyzed for biomarkers at screening and on treatment. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.|||NFU||Standard Deviation|Mean
2743502|NCT00927823|Secondary|Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21|Fresh tumor biopsy samples analysis included assessment of status of proteins indicative of phosphoinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) related pathways signaling status and cell cycle status. The biomarkers included phosphorylated activated kinase (AKT) S473, AKT T308, signal transducer and activator of transcription 3 (STAT3) and forkhead transcription factor Foxo1 (FKHR) T24/forkhead in rhabdomysacoma-like 1 (FKHRL1) T32. The method of analysis was reverse phase microarray (RPMA). The signal (normalized fluorescence unit [NFU]) for each pathway biomarker was normalized against the signal (NFU) for cytokeratin. The final concentration for each pathway biomarker was reported as a cytokeratin normalized fluorescence unit (NFC) value.|Baseline; 4 hours post-dose on C1D21|Fresh tumor biopsy analysis set included all enrolled participants in the tumor biopsy cohort who started treatment and had baseline and on-treatment fresh tumor tissue successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.|||NFC||Standard Deviation|Mean
2743503|NCT00927823|Secondary|Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively. Results of PF-04691502 2 mg and 4 mg arm not reported because none of the participants were evaluable.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2743504|NCT00927823|Secondary|Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively.|||micro International Unit/mL (mc IU/mL)||Standard Deviation|Mean
2743505|NCT00927823|Secondary|Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set included all enrolled participants who started treatment and had baseline and on-treatment serum biomarker samples (insulin, glucose, and c-peptide) successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2743506|NCT00927823|Secondary|Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants had at least 1 ECG assessment after receiving PF-04691502.|||participants|||Number
2743507|NCT00927823|Secondary|Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving PF-04691502.|||participants|||Number
2743508|NCT00927823|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where tau is the dosing interval of 24 hours. It was evaluated following repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2743525|NCT00927784|Primary|Incidence of Immune Sensitization||Measured within 90 days of study entry||||participants|||Number
2743509|NCT00927823|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2743510|NCT00927823|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeat oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.|||hours||Standard Deviation|Mean
2743511|NCT00927823|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2743512|NCT00927823|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The PK of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.|||hours||Full Range|Median
2743513|NCT00927823|Secondary|Maximum Observed Plasma Concentration (Cmax)|The pharmacokinetics (PK) of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2743514|NCT00927823|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.|||milligram|||Number
2743515|NCT00927823|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells per cubic millimeter [cells/mm^3]) for 1 week or greater, febrile neutropenia (fever >=38.5 degree celsius with ANC <1000/mm^3), grade 3 (50,000 cells/mm^3) and grade 4 (<25,000 cells/mm^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for >14 days.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.|||participants|||Number
2743516|NCT00927823|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety analysis set included all enrolled participants who started the treatment.|||participants|||Number
2743517|NCT00927784|Secondary|Incidence of Survival to Cardiac Transplantation||up to 12 months|Study terminated early. Data not collected or analyzed for this Outcome Measure.||||||
2743518|NCT00927784|Secondary|Incidence of Cell Engraftment and Fate at Explant||up to 12 months|Study terminated early. Data not collected or analyzed for this Outcome Measure.||||||
2743519|NCT00927784|Secondary|Incidence of Cardiomyocyte Regeneration at Explant||up to 12 months|Study terminated early. Data not collected or analyzed for this Outcome Measure.||||||
2743520|NCT00927784|Secondary|Incidence of Myocardial Neovascularization at Time of Explant||up to 12 months|Study terminated early. Data not collected or analyzed for this Outcome Measure||||||
2743521|NCT00927784|Secondary|Number of Patients Who Experienced Donor-specific HLA Sensitization|Number of patients who experienced donor-specific HLA sensitization post-randomization in each treatment arm.|up to 12 months|Study terminated early. Data not collected or analyzed for this Outcome Measure.||||||
2743522|NCT00927784|Secondary|Incidence of All Serious Adverse Events||up to 12 months||||events|||Number
2743523|NCT00927784|Secondary|Incidence of Study Intervention-related Adverse Events|This includes Device Malfunction-Pump Thrombus-Suspected and Internal Pump Component, Inflow, or Outflow Tract Infection|up to 12 months||||participants|||Number
2743526|NCT00927784|Primary|Incidence of Hypersensitivity Reaction||Measured within 90 days of study entry||||participants|||Number
2743527|NCT00927784|Primary|Incidence of Neoplasm||Measured within 90 days of study entry||||participants|||Number
2743530|NCT00927758|Primary|Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)|Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.|Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)|The per-protocol (PP) population was all subjects who completed the study with no major variances that would impair the analysis of the data|||Percentage change in eNO||Standard Deviation|Mean
2743531|NCT00927589|Primary|Minimum Observed Serum Trough Concentration (Cmin) of Trastuzumab||15 (±15) minutes prior to the start of the trastuzumab infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|PK analysis population for trastuzumab. n=participants with available data at each timepoint.|||mcg/mL||95% Confidence Interval|Geometric Mean
2743532|NCT00927589|Primary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab||30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|The PK analysis population for trastuzumab included all participants who had at least 1 measurable serum trastuzumab concentration collected at a nominal sampling timepoint. Participants who did not receive a trastuzumab dose or for whom no trastuzumab PK samples were reported were excluded. n=participants with available data at each timepoint.|||mcg/mL||95% Confidence Interval|Geometric Mean
2743533|NCT00927589|Primary|Plasma Decay Half-Life (t1/2) of Carboplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin. n=participants with available data at each timepoint.|||hr||Standard Deviation|Mean
2743534|NCT00927589|Primary|Geometric Mean Ratio of AUC0-6hr/D of Carboplatin|The geometric mean ratio of AUC0-6hr/D of carboplatin was defined as the AUC0-6hr/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by AUC0-6hr/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||ratio||90% Confidence Interval|Geometric Mean
2743535|NCT00927589|Primary|Dose−Normalized AUC0-6hr (AUC0-6hr/D) of Carboplatin|AUC0-6hr/D = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion, normalized by carboplatin dose level.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||(hr*mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
2743536|NCT00927589|Primary|Geometric Mean Ratio of Cmax/D of Carboplatin|The geometric mean ratio of Cmax of carboplatin was defined as the Cmax/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by Cmax/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||ratio||90% Confidence Interval|Geometric Mean
2743537|NCT00927589|Secondary|Population Pharmacokinetics of Trastuzumab|As per planned analysis, separate population pharmacokinetic analysis results are not available for the current study as this analysis is based on pooled data from multiple studies.|15 (±15) minutes prior to the start of the trastuzumab infusion, and 30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|||||||
2743538|NCT00927589|Secondary|Number of Participants With Abnormal Changes in QRS Interval|Criteria for abnormal changes in QRS interval were defined as: >=25% change from baseline, an absolute value >110 msec, or >=25% change from baseline and an absolute value >110 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
2743539|NCT00927589|Secondary|Number of Participants With Abnormal Changes in PR Interval|Criteria for abnormal changes in PR interval were defined as: =>25 percentage (%) change from baseline, an absolute value >200 msec, or >=25% change from baseline and an absolute value >200 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
2743540|NCT00927589|Secondary|Number of Participants With New Abnormal T Waves on ECG|The incidence of abnormal T-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
2743541|NCT00927589|Secondary|Number of Participants With New Abnormal U Waves on ECG|The incidence of abnormal U-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
2743542|NCT00927589|Secondary|Number of Participants With Increase From Baseline in QTc Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of =>30msec, 30 to <60 msec (borderline) and >=60 msec (prolonged) were summarized.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
2743543|NCT00927589|Secondary|Number of Participants Within Each Absolute QTc Interval Category|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum QTc less than or equal to (<=) 450 msec, greater than (>) 450 to <=470 msec, >470 to <= 500 msec, or >500 msec were reported.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
2743544|NCT00927589|Secondary|Baseline-adjusted Heart Rate|"For each postbaseline timepoint, a participant's corresponding baseline heart rate was subtracted from his or her average of the triplicate heart rate to create a baseline-adjusted corresponding heart rate for each participant at each postbaseline timepoint."|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||beats per minute (bpm)||Standard Deviation|Mean
2743545|NCT00927589|Secondary|Baseline-adjusted QTcF, QTcB, PR Interval, and QRS Duration|"For each postbaseline timepoint, a participant's corresponding baseline measure was subtracted from his or her average of the triplicate ECG measure to create a baseline-adjusted corresponding ECG measure for each participant at each postbaseline timepoint."|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||msec||Standard Deviation|Mean
2743546|NCT00927589|Secondary|Change From Baseline in Corrected QT Interval Using Bazett's Correction (QTcB) at Trastuzumab Steady State|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette's formula (QTcB = QT divided by square root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 and Cycle 2 Day 1 after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population|||msec||90% Confidence Interval|Mean
2743547|NCT00927589|Primary|Dose-Normalized Cmax (Cmax/D) of Carboplatin|Dose normalized Cmax is the maximum observed concentration of carboplatin in plasma normalized for different dose levels.|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||(mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
2743548|NCT00927589|Primary|Area Under the Curve From Time Zero to 6 Hours Post Infusion (AUC0-6hr) of Carboplatin|AUC0-6hr = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||Hour*microgram/milliliter (hr*mcg/mL)||Standard Deviation|Mean
2743549|NCT00927589|Primary|Maximum Observed Plasma Concentration (Cmax) of Carboplatin||0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The pharmacokinetic (PK) analysis population for carboplatin included all participants who had a measurable ultrafiltrate or plasma carboplatin concentration at all nominal sampling time points. Participants for whom a full set of carboplatin PK samples in both Cycle 1 and Cycle 2 was not reported were excluded.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2743550|NCT00927589|Primary|Change From Baseline in Corrected QT Interval Using Fridericia's Correction (QTcF) at Trastuzumab Steady State|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 (C1D8) and Cycle 2 Day 1 (C2D1) after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population: received any trastuzumab, had at least 1 interpretable baseline ECG measurement recorded on C1D2 prior trastuzumab exposure, had at least 1 interpretable ECG measurement recorded on C1D8 or C2D1 corresponding to time of steady-state trastuzumab concentration, and no infusion reaction requiring drug treatments.|||milliseconds (msec)||90% Confidence Interval|Mean
2743551|NCT00927576|Primary|Performance in TBI Patients and Controls|Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure.|Subjects were tested in a single 2-hr session.|Data from two TBI patients were excluded due to suspected suboptimal effort.|||ms||Standard Deviation|Mean
2744184|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||μU/μL||Standard Deviation|Mean
2743553|NCT00927563|Secondary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.|Visit 5 (final visit)||||units on a scale||Standard Deviation|Mean
2743554|NCT00927563|Primary|Clinical Global Impression Scale (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.|Visit 5 (final visit)||||units on a scale||Standard Deviation|Mean
2743555|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)|"Treatment Success in the Modified ITT (non LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."|||percentage of subjects|||Number
2743556|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)|"Treatment Success in the Modified ITT (LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations was in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."|||percentage of subjects|||Number
2743557|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP|"Treatment Success in the PPP~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the PPP was considered supportive."|3 weeks|"The evaluations in the PPP was considered supportive The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 188; frequency missing = 33."|||percentage of subjects|||Number
2743558|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))|"Treatment Success in the Efficacy ITT (non LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|"Treatment Success was evaluated in the Efficacy ITT(non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13."|||percentage of subjects|||Number
2743559|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).|"Treatment Success in the Modified ITT (non-LOCF)~The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.~Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified ITT (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.|||percentage of subjects|||Number
2743560|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)|"Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF)~The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified Intention to Treat ( Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.|||percentage of subjects|||Number
2743561|NCT00927472|Primary|Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment|"Treatment Success in the Per Protocol Population (PPP)~The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive."|3 weeks|The Per-Protocol Population (PPP) included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.|||percentage of subjects|||Number
2743562|NCT00927472|Primary|Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment|"Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF)~The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)."|3 weeks|Treatment Success in the Efficacy ITT (No LOCF) The Efficacy ITT population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.|||percentage of subjects|||Number
2743563|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))|"Treatment Success in the Efficacy ITT (LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|Treatment Success in the Efficacy ITT (LOCF). The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13.|||percentage of subjects|||Number
2743591|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 1, 3, and 6 Endpoint|OC is a measure of osteoblast function.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.|||µg/L||Inter-Quartile Range|Median
2743564|NCT00927472|Primary|Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.|"Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.~The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).~Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))"|3 weeks|"The Efficacy Intention to Treat (eITT) population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.~eITT population: included all index subjects with at least one application of treatment.~Proportion of Subjects that are lice-free 14 days after their last treatment"|||percentage of subjects|||Number
2743565|NCT00927394|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|"Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.~Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards."|8 weeks|Safety Set — Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.|||Patients|||Number
2743566|NCT00927394|Secondary|Change From Baseline in Plasma Aldosterone at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||pmol/L||Standard Deviation|Mean
2743567|NCT00927394|Secondary|Change From Baseline in Plasma Renin Concentration (PRC) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||ng/L||Standard Deviation|Mean
2743568|NCT00927394|Secondary|Change From Baseline in Plasma Renin Activity (PRA) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||ng/mL/hr||Standard Deviation|Mean
2743569|NCT00927394|Secondary|Percentage of Responders|Responders were defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.|Baseline, Week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||Percentage of patients|||Number
2743570|NCT00927394|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control was defined as MSSBP/MSDBP <140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported|8 weeks|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.|||Percentage of patients|||Number
2743571|NCT00927394|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8|At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.|baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.|||mmHg||Standard Deviation|Mean
2743572|NCT00927394|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.|||mmHg||Standard Deviation|Mean
2743573|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8|The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.|||mmHg||Standard Deviation|Mean
2743574|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8|The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.|||mmHg||Standard Deviation|Mean
2743708|NCT00926575|Secondary|Cumulative Exposure to Prednisone||Day 80|||||||
2743575|NCT00927394|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.|||mmHg||Standard Deviation|Mean
2743576|NCT00927394|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8|The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.|||mmHg||Standard Deviation|Mean
2743577|NCT00927368|Secondary|Incremental Cost of Femoral Nerve Blocks|The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate.|postoperative period when block is used||||dollars||Standard Deviation|Mean
2743578|NCT00927368|Secondary|Block Performance Time|Block performance time, defined as the time from block start until catheter placement.|time elapsed from beginning the block to catheter placement||||seconds||95% Confidence Interval|Mean
2743579|NCT00927368|Primary|Opioid Consumption|cumulative opioid consumption, where all opioids were converted to IV morphine equivalents|48 hours after surgery||||mg morphine equivalents||Inter-Quartile Range|Median
2743580|NCT00927368|Primary|Time Weighted Average Verbal Response Scale Pain Score|"Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).~Verbal Response Scale (VRS) pain scores after surgery - which ranged from 0 (no pain) to 10 (maximum intolerable pain) - were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.)."|48 hours after surgery||||units on a scale||Standard Deviation|Mean
2743581|NCT00927355|Secondary|Bone Mineral Density||6 months||||percent change from baseline to 6 months||Standard Error|Mean
2743582|NCT00927355|Secondary|βCTX (Carboxy Terminal Collagen Crosslinks), Osteocalcin, and Adiponectin.||6 months||||percent change from baseline||Standard Error|Mean
2743583|NCT00927355|Primary|Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline|To determine the effect of PIO (pioglitazone) on BMSC (bone marrow stem cell) lineage choice in vivo, a bone marrow aspiration was obtained from patients at baseline and after 6 months of treatment with PIO or placebo. The bone marrow was used for ex vivo CFU-OB (Colony forming units-Osteoblast) and CFU-AD assays using the same protocol described for the in vitro studies previously. We also analyzed the number of total colonies per patient at both baseline and final visit.|6 months||||percent change from baseline to 6months||Standard Error|Mean
2743584|NCT00927264|Secondary|Number of Participants Who Report Endorsing a Home Smoking Ban|Number of participants endorsing presence of home smoking ban|Measured at baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact|||Participants|||Count of Participants
2743585|NCT00927264|Secondary|Health Care Utilization by Child- Self Report From Parent/Caregiver|Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study|Measured at baseline and 3, 6 and 12 months||||Participants|||Count of Participants
2743586|NCT00927264|Secondary|Respiratory Function of Child by Self Report of Parent|Number of cold infections child experienced in previous 3 months, reported by caregiver|Measured at Baseline, 3, 6, and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact or caregiver refused or did not fully complete survey|||cold infections||Standard Deviation|Mean
2743587|NCT00927264|Secondary|ETS Reduction, as Measured by Child's Cotinine Levels|Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction|Measured at Baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact, samples not able to be analyzed due to insufficient quantity of saliva collected, or child not available during assessment.|||ng/mL||Inter-Quartile Range|Median
2743588|NCT00927264|Primary|Air Nicotine Levels|Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)|Measured at Baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact|||mg/m^3||Inter-Quartile Range|Median
2743589|NCT00927251|Primary|Number of Participants With Left Ventricular (LV)Lead Related Complications|A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.|Implant to one-month post implant|All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention|||participants|||Number
2743592|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 12 Endpoint|PINP is a measure of bone formation.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months PINP measurement.|||microgram/liter (µg/L)||Inter-Quartile Range|Median
2743593|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 1, 3 and 6 Endpoint|PINP is a measure of bone formation.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.|||microgram/Liter (µg/L)||Inter-Quartile Range|Median
2743594|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 12 Endpoint|CTX is a measure of bone resorption.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months CTX measurement.|||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
2743595|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 1, 3 and 6 Endpoint|CTX is a measure of bone resorption.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.|||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
2743596|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Eroded surface/bone surface (ES/BS) in the endocortical compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the EC at 6 and 24 months.|||percentage of surface||Inter-Quartile Range|Median
2743597|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the CC at 24 months.|||percentage of surface||Inter-Quartile Range|Median
2743598|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of surface||Inter-Quartile Range|Median
2743599|NCT00927186|Secondary|Wall Thickness (WTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Wall thickness (WTh.) in the endocortical compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the EC at 6 and 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
2743600|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the CC at 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
2743601|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||µm||Inter-Quartile Range|Median
2743602|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid thickness (OTh.) in the endocortical compartment is a measure of the average thickness of osteoid seams.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the EC at 6 and 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
2743603|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the CC at 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
2743604|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||micrometer (µm)||Inter-Quartile Range|Median
2743605|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid surface (OS) in the endocortical compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the EC at 6 and 24 months.|||percentage of surface||Inter-Quartile Range|Median
2743606|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the CC at 24 months.|||percentage of surface||Inter-Quartile Range|Median
2743607|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of surface||Inter-Quartile Range|Median
2743608|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OV/BV analysis of the CC at 24 months.|||percentage of volume||Inter-Quartile Range|Median
2743609|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of volume||Inter-Quartile Range|Median
2743610|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the endocortical compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the endocortical compartment at 6 and 24 months.|||millimeter (mm)||Inter-Quartile Range|Median
2743611|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the cancellous compartment at 24 months.|||millimeter (mm)||Inter-Quartile Range|Median
2743612|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||millimeter (mm)||Inter-Quartile Range|Median
2743613|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the endocortical compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the endocortical compartment at 6 and 24 months.|||samples|||Number
2743614|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the cancellous compartment at 24 months.|||samples|||Number
2743615|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||samples|||Number
2743616|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the endocortical compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the endocortical compartment at 6 and 24 months.|||percentage of tetracycline labels||Inter-Quartile Range|Median
2743757|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5|SBP control is defined as SBP < 140 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743617|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the cancellous compartment at 24 months.|||percentage of tetracycline labels||Inter-Quartile Range|Median
2743618|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of tetracycline labels||Inter-Quartile Range|Median
2743619|NCT00927186|Secondary|Active Formation Period (a.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|a. FP in EC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3 day-periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the EC at 6 and 24 months.|||year||Inter-Quartile Range|Median
2743620|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the CC at 24 months.|||year||Inter-Quartile Range|Median
2743621|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||year||Inter-Quartile Range|Median
2743622|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Tt.FP in EC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the EC at 6 and 24 months.|||year||Inter-Quartile Range|Median
2743623|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the CC at 24 months.|||year||Inter-Quartile Range|Median
2743624|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||year||Inter-Quartile Range|Median
2743625|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Omt in EC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 Months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the EC at 6 and 24 months.|||day||Inter-Quartile Range|Median
2770990|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2743626|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the CC at 24 months.|||day||Inter-Quartile Range|Median
2743627|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||day||Inter-Quartile Range|Median
2743628|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Mlt in EC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the EC at 6 and 24 months.|||day||Inter-Quartile Range|Median
2743629|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the CC at 24 months.|||day||Inter-Quartile Range|Median
2743630|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as Osteoid Thickness (O.Th) divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||day||Inter-Quartile Range|Median
2743631|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Aj.AR in EC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the EC at 6 and 24 months.|||micrometer (µm)/day||Inter-Quartile Range|Median
2743632|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the CC at 24 months.|||micrometer (µm)/day||Inter-Quartile Range|Median
2743633|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||µm/day||Inter-Quartile Range|Median
2743634|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MAR in EC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the EC at 6 and 24 months.|||micrometer (µm/day)||Inter-Quartile Range|Median
2743635|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the CC at 24 months.|||micrometer (µm)/day||Inter-Quartile Range|Median
2743636|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive T labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||micrometer (µm)/day||Inter-Quartile Range|Median
2743637|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|BFR in EC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of EC at 6 and 24 months.|||mm³/mm²/year||Inter-Quartile Range|Median
2743638|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of the CC at 24 months.|||mm³/mm²/year||Inter-Quartile Range|Median
2743639|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (cubic millimeter/square millimeter/year [mm³/mm²/year]); calculated as mineral apposition rate (MAR) times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||mm³/mm²/year||Inter-Quartile Range|Median
2743640|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Ac.f in EC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the EC at 6 and 24 months.|||new cycles/year||Inter-Quartile Range|Median
2743641|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the CC at 24 months.|||new cycles/year||Inter-Quartile Range|Median
2743642|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on BS (bone formation rate [BFR]/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 micrometer (µm)/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||new cycles/year||Inter-Quartile Range|Median
2743709|NCT00926575|Primary|The Proportion of Subjects With GVHD Treatment Failure|The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD|Day 80|Data was not analyzed as the study was terminated due to futility||||||
2743643|NCT00927186|Secondary|Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months.|||percentage of surface||Inter-Quartile Range|Median
2743644|NCT00927186|Secondary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the CC at 24 months.|||percentage of surface||Inter-Quartile Range|Median
2743645|NCT00927186|Primary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of surface||Inter-Quartile Range|Median
2743646|NCT00927160|Secondary|Rehospitalization Rate|30 days for readmission rate|30 days||||percentage of particpants|||Number
2743647|NCT00927160|Primary|Length of Hospital Stay||Depending on hospital stay||||days||Standard Deviation|Mean
2743648|NCT00927095|Primary|Pre-Post Change in Premenstrual Symptom Severity|"Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: mean rating on the individual's worst symptom during the premenstrual week at baseline minus mean rating during the premenstrual week during the last on-treatment cycle. Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial."|monthly||||units on a scale||Standard Deviation|Mean
2743649|NCT00927082|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.|||Participants|||Number
2743650|NCT00927082|Secondary|Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)|Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.|||Participants|||Number
2743651|NCT00927082|Secondary|Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B|Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.|Up to 5-year FU period|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Participants|||Number
2743710|NCT00926536|Primary|Cumulative Dose (CD), a Measure of Radiation Dose|CD - a measurement of total radiation to the skin (measure of a deterministic dose)|Duration of a TACE procedure, an average of 2 hours|CD measured in both groups|||mGy||Full Range|Mean
2744185|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||μU/μL||Standard Deviation|Mean
2743652|NCT00927082|Secondary|Quantitative HBsAg|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||log10 IU/mL||Standard Deviation|Mean
2743653|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743654|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743655|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).|The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743656|NCT00927082|Primary|Percentage of Participants With HBsAg Loss|HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage||95% Confidence Interval|Number
2743657|NCT00927082|Secondary|Percentage of Participants With Normalised Alanine Transaminase (ALT)|Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743658|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-HBs|The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743659|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).|The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743660|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743661|NCT00927082|Secondary|Percentage of Participants With HBeAg Loss.|HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743662|NCT00927082|Primary|Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.|Annually, for up to 5 years|The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
2743663|NCT00927069|Secondary|Total Number of Adverse Events for All Patients in the Study.|Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Adverse events|||Number
2743664|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
2743665|NCT00927069|Secondary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
2743666|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
2743667|NCT00927069|Primary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
2743668|NCT00926952|Secondary|Number of Adverse Events|To study the safety of MAL-PDT performed without occlusion when red light exposure takes place 90 minutes after the application of MAL by tracking adverse events until week 12 and adverse events until week 24|12, 24 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Adverse events|||Number
2743669|NCT00926952|Secondary|Mean Mottled Hyperpigmentation at Week 12|"This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
2743670|NCT00926952|Secondary|Mean Sallowness Score at Week 12|"This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
2743671|NCT00926952|Secondary|Mean Coarse Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
2743672|NCT00926952|Secondary|Mean Fine Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
2770991|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2743673|NCT00926952|Secondary|Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12|Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
2743674|NCT00926952|Secondary|Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12||0, 12 weeks||||Lesions|||Number
2743675|NCT00926952|Secondary|Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12|The proportion of patients with a complete clinical response is calculated by dividing the number of patients with a complete response at week 12 by the number of participants at baseline.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Participants|||Number
2743676|NCT00926952|Primary|Mean Number of Facial Actinic Keratoses at Week 12||12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Lesions||Standard Deviation|Mean
2743677|NCT00926887|Primary|Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'|24 hours|Intention to treat (ITT) analysis with imputation technique of Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
2743678|NCT00926887|Secondary|Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale||7 days post surgery|||||||
2743679|NCT00926887|Secondary|Infection Evaluation||24 hours & 7 days post surgery|||||||
2743680|NCT00926887|Secondary|Hydration Level Assessment||immediately, 24 hours & 7 days post surgery.|||||||
2743681|NCT00926887|Secondary|Use of Pain Management Medication Post-surgically.|Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.|Through the 1st 7 post-operative days.|ITT with LOCF|||medication doses||Standard Deviation|Mean
2743682|NCT00926887|Secondary|Self-reported Degree of Pain Rating in the Breasts Area.||24 hours, 7 days, 14 days & 28 days post surgery|||||||
2743683|NCT00926887|Secondary|Swelling Evaluation Through Length by Width Breast Diameter Measurements||immediately, 24 hours & 7 days post surgery|||||||
2743684|NCT00926887|Primary|Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.|24 hours post-operative|ITT Analysis with LOCF technique employed, as applicable.|||participants|||Number
2743685|NCT00926848|Secondary|Functional Capacity in Partners|Exercise tolerance test using a treadmill|6 months post baseline||||Metabolic equivalents (METs)||Standard Deviation|Mean
2743686|NCT00926848|Secondary|Functional Capacity in Patients|Exercise tolerance test using a treadmill|6 months post baseline||||Metabolic equivalents (METs)||Standard Deviation|Mean
2743687|NCT00926848|Primary|Eating Behavior (% Saturated Fat) in Partners|Eating behavior (% saturated fat) was measured using a 3-day food record.|6 months post baseline||||percent saturated fat per day||Standard Deviation|Mean
2743688|NCT00926848|Primary|Eating Behavior (% Saturated Fat) in Patients|Eating behavior (% saturated fat) was measured using a 3-day food record.|6 months post baseline||||percent saturated fat per day||Standard Deviation|Mean
2743689|NCT00926848|Primary|Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners|Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.|6 months post enrollment/baseline||||minutes per day||Standard Deviation|Mean
2743690|NCT00926848|Primary|Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients|Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.|6 months post enrollment/baseline||||minutes per day||Standard Deviation|Mean
2743691|NCT00926796|Secondary|Number of Participants With Adverse Events for Each Regimen|Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.|Day 0 through Day 30|All participants receiving study medication comprised the safety population. Of 614 participants randomized, 603 received study medication.|||participants|||Number
2743692|NCT00926796|Primary|Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||percentage of participants|||Number
2743693|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Enrollment Isolates.|Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants|Isolates obtained at enrollment (Day 0).|Per protocol population (all randomized participants who too study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.).|||micrograms/milliliter||Full Range|Median
2743711|NCT00926536|Primary|Dose Area Product (DAP)|Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)|Duration of a TACE procedure, an average of 2 hours|DAP measured in both groups|||Gy.cm2||Full Range|Mean
2743694|NCT00926796|Secondary|Resolution of Symptoms and Signs (Clinical Cure)|Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.|10-17 days after treatment.|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||participants|||Number
2743695|NCT00926796|Secondary|Clinical Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.|10-17 days|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.|||participants|||Number
2743696|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).|Isolates obtained at enrollment (Day 0).|Participants in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.|||micrograms/milliliter||Full Range|Median
2743697|NCT00926796|Secondary|Eradication of Pharyngeal Infection|Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for pharyngeal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||participants|||Number
2743698|NCT00926796|Secondary|Eradication of Rectal Infection|Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for rectal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||participants|||Number
2743699|NCT00926796|Primary|Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||percentage of participants|||Number
2743700|NCT00926783|Secondary|Incidence of Atrial Fibrillation (AF) Termination/Regularization|Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data|||participants|||Number
2743701|NCT00926783|Secondary|Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target|Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target|Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)|Per-protocol population with available outcome data|||Milliseconds||Standard Deviation|Mean
2743702|NCT00926783|Secondary|Fluoroscopy Time|"Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms.~Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis."|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data|||Minutes||Standard Deviation|Mean
2743703|NCT00926783|Secondary|Duration of Ablation Procedure|Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.|Duration of ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data|||Minutes||Standard Deviation|Mean
2743704|NCT00926783|Primary|Total Radio-frequency (RF) Delivery Time During CFAE|Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)||||Minutes||Standard Deviation|Mean
2743705|NCT00926783|Primary|Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.|Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.|From day 91 to day 365 post first ablation procedure|Per-protocol population - subjects who underwent repeat ablation procedures within six months of initial procedures.|||participants|||Number
2743706|NCT00926588|Primary|Brief Pain Inventory (Pain)|The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain).|1 year||||units on a scale||Standard Deviation|Mean
2743707|NCT00926575|Secondary|Survival Status||Day 200|||||||
2743715|NCT00926393|Secondary|Number of Patients With Potential Extrapyramidal Symptoms (EPS)|Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness|From start of the study treatment to last dose plus 30 days|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||Patients|||Number
2743716|NCT00926393|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||units on scale||Standard Deviation|Mean
2743717|NCT00926393|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||units on scale||Standard Deviation|Mean
2743718|NCT00926393|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||units on scale||Standard Deviation|Mean
2743719|NCT00926393|Secondary|Area Under the Modified Bond-Lader Visual Analog Scale-time Curve|Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose|During Day 2 (50 mg)|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||mm * hour||Standard Error|Least Squares Mean
2743720|NCT00926393|Secondary|Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||Hours||Standard Error|Least Squares Mean
2743721|NCT00926393|Secondary|Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
2743722|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 6 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
2743723|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 5 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
2743724|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 4 (200 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
2743725|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 3 (100 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
2744186|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||μU/μL||Standard Deviation|Mean
2743726|NCT00926393|Primary|Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||95% Confidence Interval|Least Squares Mean
2743727|NCT00926380|Primary|Change in Spine Bone Density From Baseline to 2 Years||Baseline and 2 years||||percent change||Standard Error|Mean
2743728|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult"|Day 14||||units on a scale||Standard Deviation|Mean
2743729|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?~The subject replied using the following scale:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied"|Day 14||||units on a scale||Standard Deviation|Mean
2743730|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult"|Day 14||||units on a scale||Standard Deviation|Mean
2743731|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?~The subject replied using the following scale:~1 - Yes 0 - No"|Day 14||||units on a scale||Standard Deviation|Mean
2743732|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?~The subject replied using the following scale:~0 - Not Compliant at all (<50%)~- Mostly Compliant (50%-79%)~- Very Compliant (80%-100%)"|Day 14||||units on a scale||Standard Deviation|Mean
2743733|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?~The subject replied using the following scale:~- Very Comfortable~- Comfortable~- Somewhat Comfortable~- Somewhat Uncomfortable~- Uncomfortable"|Day 14||||units on a scale||Standard Deviation|Mean
2743734|NCT00926367|Secondary|Self Assessment of Oiliness|"The amount of oiliness on the left and right cheek of each panelist.~The scale used to evaluate oiliness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743735|NCT00926367|Secondary|Self Assessment of Blistering|"The amount of blistering on the left and right cheek of each panelist.~The scale used to evaluate blistering is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743736|NCT00926367|Secondary|Self Assessment of Crusting|"The amount of crusting on the left and right cheek of each panelist.~The scale used to evaluate crusting is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743737|NCT00926367|Secondary|Self Assessment of Pain|"The amount of pain on the left and right cheek of each panelist.~The scale used to evaluate pain is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743738|NCT00926367|Secondary|Self Assessment of Texture (Roughness)|"The amount of roughness on the left and right cheek of each panelist.~The scale used to evaluate roughness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743739|NCT00926367|Secondary|Self Assessment of Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate dryness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743740|NCT00926367|Secondary|Self Assessment of Stinging|"The amount of stinging on the left and right cheek of each panelist.~The scale used to evaluate stinging is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743741|NCT00926367|Secondary|Self Assessment of Burning|"The amount of burning on the left and right cheek of each panelist.~The scale used to evaluate burning is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2770992|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2743742|NCT00926367|Secondary|Skin Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14||||Microsiemens||Standard Deviation|Mean
2743743|NCT00926367|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
2743744|NCT00926367|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss."|Baseline, Days 3, 7, and 14||||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
2743745|NCT00926367|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|Baseline, Day 1 through Day 14||||Units on a scale||Standard Deviation|Mean
2743746|NCT00926328|Primary|Plaque Index|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 Months|Per protocol|||Units on a scale||Standard Deviation|Mean
2743747|NCT00926328|Primary|Gingivitis Index|"Units on a scale 0 to 3 (0 = no inflammation ,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.~3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|6 months||||Units on a scale||Standard Deviation|Mean
2743748|NCT00926289|Secondary|BP Categories at Week 7|"BP categories comprise:~BP optimal (SBP <120 mmHg and DBP <80 mmHg)~BP normal (SBP <130 mmHg and DBP <85 mmHg but not 'optimal')~BP high normal (SBP <140 mmHg and DBP <90 mmHg but not 'normal')~Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not 'high normal')~Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not 'Grade 1 hypertension')~Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)"|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743749|NCT00926289|Secondary|Number of Participants With DBP Response at Week 7|DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743750|NCT00926289|Secondary|Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7|SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743751|NCT00926289|Secondary|Number of Patients With BP Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743752|NCT00926289|Secondary|Number of Patients With Blood Pressure (BP) Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743753|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3|DBP control is defined as DBP<90 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743754|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5|DBP control is defined as DBP<90 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||participants|||Number
2743755|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7|DBP control is defined as DBP<90 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743756|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3|SBP control is defined as SBP < 140 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743758|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7|SBP control is defined as SBP < 140 mmHg.|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
2743759|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7|The DBP value at baseline was subtracted from the DBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
2743760|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 3|The SBP value at baseline was subtracted from the SBP value at Week 3.|Baseline and Week 3|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
2743761|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 5|The SBP value at baseline was subtracted from the SBP value at Week 5.|Baseline and Week 5|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
2743762|NCT00926289|Primary|Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7|The SBP value at baseline was subtracted from the SBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
2743763|NCT00926263|Secondary|Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples|Number of participants who tested positive for ADA|Day 1 pre-dose, Day 15, 29, 57, 85|All treated participants.|||number of participants|||Number
2743764|NCT00926263|Secondary|Serum Concentration of Fasting Glucose|Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||mg/dL||Standard Deviation|Mean
2743765|NCT00926263|Secondary|Serum Concentration of Insulin|Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||mIU/mL||Standard Deviation|Mean
2743766|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)|IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
2743767|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)|IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
2743768|NCT00926263|Secondary|Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
2743769|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
2743770|NCT00926263|Secondary|QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours||baseline, 3 hours postdose|Data not obtained due to early termination of the study.||||||
2743771|NCT00926263|Primary|QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level|QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction|Day 1 at 1 and 24 hours post-dose, Day 7, 28|Data not obtained due to early termination of the study.||||||
2743772|NCT00926263|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).|||days||Standard Deviation|Mean
2744124|NCT00923845|Secondary|Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen|Occurrence of infection by Common Terminology Criteria for Adverse Events (CTCAE).|During the 21-day PC regimen||||Participants|||Count of Participants
2743773|NCT00926263|Primary|Apparent Volume of Distribution (Vz)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).|||mL/kg||Standard Deviation|Mean
2743774|NCT00926263|Primary|Plasma Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).|||mL/day/kg||Standard Deviation|Mean
2743775|NCT00926263|Primary|Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.|||mg*h/L||Standard Deviation|Mean
2743776|NCT00926263|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.|||mg/L||Standard Deviation|Mean
2743777|NCT00926211|Secondary|Proportion of Harvested Follicles Transected|The proportion of harvested hair follicles that were transected by each harvest method.|Time of harvest (Baseline)||||Proportion of transected follicles||Standard Deviation|Mean
2743778|NCT00926211|Primary|Increase in Hair Follicles Present|The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.|Change from Baseline at 9 Months|The analysis was based on intention to treat (ITT). Imputation technique was based LOCF.|||Hair follicles||Standard Deviation|Mean
2743779|NCT00926185|Secondary|Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline (Day 0) and Day 84|ITT set with LOCF was used for analysis of this outcome. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
2743780|NCT00926185|Primary|Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Day 84|Intent-to-treat (ITT) population with LOCF defined as all randomized subjects. For the efficacy analysis, the Last Observation Carried Forward (LOCF) method will be used to impute missing values.|||units on a scale||Standard Deviation|Mean
2743781|NCT00926029|Primary|Gingivitis Index|Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 Weeks||||Units on a scale||Standard Deviation|Mean
2743782|NCT00926029|Primary|Plaque Index|Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||Units on a scale||Standard Deviation|Mean
2743783|NCT00926003|Secondary|Achenbach Child Behavior Checklist (CBCL) Total Score|Child Behavior Checklist (CBCL) total score Total problems T-scores (standardized). This is a standardized score with a mean of 50 and a standard deviation of 10, with higher scores indicating more symptoms of either emotional (internalizing) or behavioral (externalizing) or other (e.g., sleep disturbances) nature. Range for our children on this scale is typically from 40 to 80. These are t scores based on Cross-Cultural norms, whereby higher scores (more symptoms or problems) indicate a worse outcome.|CBCL total score at post-training (3 months), adjusted by the baseline score, so that a single score appears in the results table.|3-mo follow-up means adjusted for outcome at baseline, ARV treatment status|||T scores based on cross cultural norms||Standard Error|Mean
2743784|NCT00926003|Primary|Neuropsychological Performance (KABC2)|Kaufman Assessment Battery for Children, 2nd edition (KABC-II) Mental Processing Index (MPI), which is a global cognitive ability performance composite that is a standard score with a mean of 100 and a standard deviation of 15, with scores for our population of children typically ranging from 55 to 130. the MPI is comprised of the standardized global scores for the cognitive domains of Sequential Processing, Simultaneous Processing, Learning, and Planning. These standardized global domain scores are summed and converted (on the basis of age of child, using American norms) to a composite global performance measure called the Mental Processing Index (MPI) standard score (T score). Higher T scores indicate better performance and a better neuropsychological outcome.|KABC-II MPI score at post-training 3 mo follow-up assessment, adjusted for baseline KABC-II MPI performance. Therefore, only a single score appears in the table.||||T scores from USA norms for this test||Standard Error|Mean
2743785|NCT00925990|Secondary|Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment|"Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented.~Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)"|Baseline and 24 weeks|All patients dosed with at least one dose of study drug were analyzed.|||IU/mL||Standard Deviation|Mean
2744187|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||μU/μL||Standard Deviation|Mean
2743786|NCT00925990|Primary|Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment|"Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood from before treatment (baseline) through 24 weeks of treatment.~Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)"|Baseline and 24 weeks|All patients receiving at least one dose of study drug were analyzed for safety.|||log (IU/mL)||Standard Deviation|Mean
2743787|NCT00925938|Secondary|Percentage of Participants With Adverse Events||9 days||||Percentage of participants|||Number
2743788|NCT00925938|Secondary|Physician Assessment of Ease of Cervical Dilation;||18 - 24 hours||||percentage of participants|||Number
2743789|NCT00925938|Secondary|Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;||18 - 24 hours||||minutes||Standard Deviation|Mean
2743790|NCT00925938|Secondary|Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access||18 - 24 hours|A total of 46 subjects (90.2%) did not achieve their target dilatation after study drug removal (MVPI 400: 8 subjects; MVPI 800: 21 subjects; Placebo: 17 subjects). Forty-five subjects had additional dilatation attempted; additional dilatation was not attempted on one subject (MVPI 800) due to a protocol deviation (MVPI 800: 20 subjects).|||percentage of participants|||Number
2743791|NCT00925938|Primary|Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).||Baseline to 18-24 hours||||mm||Standard Deviation|Mean
2743792|NCT00925899|Secondary|General Fatigue Measured by the The Multidimensional Fatigue Inventory (MFI)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~The general fatigue scale that consits of four items was converted to a 0 til 100 scale where 100 indicated maximum (worst possible) fatigue.~Note outcome reported for complete compliers"|One week||||units on a scale||Standard Deviation|Mean
2743793|NCT00925899|Secondary|Appetite Loss as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Appetite loss was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum appetite loss (worst possible).~Note outcome reported for complete compliers"|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
2743794|NCT00925899|Secondary|Quality of Life as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Quality of Life was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated best possible quality of life.~Note outcome reported for complete compliers"|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
2743795|NCT00925899|Secondary|Pain as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Pain was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum pain.~Note outcome reported for complete compliers"|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
2743796|NCT00925899|Secondary|Emotional Function as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Emotional function was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated the best possible emotional function.~Note outcome reported for complete compliers"|One week||||units on a scale||Standard Deviation|Mean
2743797|NCT00925899|Secondary|Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL|"Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Insomnia was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum insomnia."|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
2743798|NCT00925899|Primary|Fatigue as Measured by the Physical Fatigue Scale in the The Multidimensional Fatigue Inventory (MFI) (Smets EM, Garssen B, Bonke B, et al., J Psychosom Res 39:315-325, 1995)|"Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~The physical fatigue scale conists of four item each ranging from one to five. The four item were summed and the scae was converted to 0 to 100, where 100 indicated maximum fatigue."|One week|The primary analysis was a per protocol analysis including only complete compliers, defined as those patients who had consumed at least 5 capsules per week for the 2 weeks in part 1 and who had answered the MFI-20 on days 1, 7, 10, and 17.|||units on a scale||Standard Deviation|Mean
2743799|NCT00925782|Primary|Concentration-Max (Cmax)|"Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.~The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.|||ng/mL||Standard Deviation|Geometric Mean
2743800|NCT00925782|Secondary|Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed.~Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.|||days||Standard Deviation|Mean
2743801|NCT00925782|Secondary|Determination of Myeloablation Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"ANC <0.5 × 109/L, absolute lymphocyte count (ALC) <0.1 × 109/L, platelet count <20,000/mm3, or bleeding requiring transfusion. The first of 2 consecutive days for which cell counts drop below these cutoff levels was recorded as the date of myeloablation.~Since the two treatments were administered consecutively with 1 day rest, the time to myeloablation and myeloablation rate was measured after both treatments were administered.~Comparison of sequence effect was not planned in the study and due to small sample size, it was not performed."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.|||days||Standard Deviation|Mean
2743802|NCT00925782|Primary|Area Under the Curve (0-t)|"AUC (0-t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.~The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|"The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection.~The results are presented by each drug group that combines data from both sequence."|||min*ng/mL||Standard Deviation|Geometric Mean
2743803|NCT00925769|Primary|Part 1: PRD of Bevacizumab for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/kg Q2W|||Number
2743804|NCT00925769|Primary|Part 1: PRD of Erlotinib for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/day|||Number
2743805|NCT00925769|Secondary|Part 2: Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|From baseline until death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
2743806|NCT00925769|Secondary|Part 2: Percentage of Participants With Clinical Benefit Response|"Clinical benefit response was defined as a composite of pain control, Karnofsky performance status (KPS), and weight. The KPS allows participants to be classified as per their functional impairment (abnormal function). It was recorded on an 11-point scale; 0= dead to 100= Normal, no complaints, no evidence of disease and sub-divided to 3 categories; 0 to 40 = Unable to care for self, requires institutional or hospital care or equivalent, disease may be rapidly progressing; 50 to 70= Unable to work, able to live at home and care for most personal needs, varying amount of assistance needed and 80 to 100= Able to carry on normal activity; no special care is needed."|One week before start of study treatment and weekly until disease progression or death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
2743807|NCT00925769|Secondary|Part 2: Percentage of Participants With Disease Control|A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) during the assessment. As per RECIST v1.1, CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|From baseline thereafter, every 6 weeks (±7 days), then 1 week after last dose (follow-up), thereafter every 6 weeks (±7 days) until disease progression (up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
2743808|NCT00925769|Secondary|Part 2: Percentage of Participants Free From Disease Progression|As per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Month 6|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
2743809|NCT00925769|Secondary|Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||h*µg/mL||Standard Deviation|Mean
2743810|NCT00925769|Secondary|Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||µg/mL||Standard Deviation|Mean
2743811|NCT00925769|Secondary|Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||hours (h)||Full Range|Median
2743812|NCT00925769|Primary|Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/m^2 BID|||Number
2743813|NCT00925769|Primary|Part 1: MTD of Bevacizumab|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/kg once every 2 weeks (Q2W)|||Number
2743814|NCT00925769|Secondary|Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR])||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
2743846|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743815|NCT00925769|Primary|Part 1: MTD of Erlotinib|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/day|||Number
2743816|NCT00925769|Primary|Part 1: Maximum Tolerated Dose (MTD) of Capecitabine|MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33 percent (%) of participants of the same quality category. DLT was defined as any greater than or equal to (>=) Grade (G) 3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to adverse events (AEs).|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/m^2 BID|||Number
2743817|NCT00925704|Secondary|Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set|||hours||95% Confidence Interval|Median
2743818|NCT00925704|Secondary|Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set|||pg/ml||95% Confidence Interval|Least Squares Mean
2743819|NCT00925704|Primary|Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|Pharmacokinetic set (PK) consists of subjects who received at least 1 dose of investigational product, had evaluable serum concentration-time profiles for calcitriol through 48 hours post-dosing on Day 1 of any treatment period and did not vomit between dosing and 10 hours post-dose on Day 1 of that treatment period.|||pg*h/ml||95% Confidence Interval|Least Squares Mean
2743820|NCT00925600|Other Pre-specified|Number of Participants With Adverse Events|"Adverse events (AEs) were assessed for severity by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) severity grading scale, version 3.0, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 =Life-threatening AE and Grade 5 = Death due to AE.~Treatment-related AEs (TRAEs) include only events for which the investigator indicated there was a reasonable possibility they may have been caused by the study drug."|12 months|All enrolled participants who received at least one dose of study drug. Three participants randomized to the placebo group who received at least 1 dose of denosumab in error are analyzed in the denosumab group for safety.|||participants|||Number
2743821|NCT00925600|Other Pre-specified|Change From Baseline in Refraction Needed to Achieve BCVA|Refraction error was measured using a phoropter. The change from baseline in spherical refraction error needed to achieve BCVA is reported.|Baseline and months 3, 6, 9, and 12|"Lens opacification analysis set with evaluable assessments at both baseline and each time point in the same eye.~n=the number of evaluable eyes in the lens opacification analysis set at the corresponding time point; 3 participants randomized to placebo who received denosumab in error are analyzed in the denosumab group."|||diopters|eyes|Standard Deviation|Mean
2743822|NCT00925600|Other Pre-specified|Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters|"The best corrected visual acuity (BCVA) is the best vision one can achieve with correction (such as eye glasses) as measured on an eye chart. BCVA was assessed by a trained ophthalmologist using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at 4 meters. The modified University of Crete ETDRS chart was used in Ukraine, Greece, Russia and Bulgaria, which do not use the Roman alphabet. The 2000 series revised ETDRS chart was used to assess the change in all other countries.~The letter score was calculated based on the number of letters that were correctly identified; higher letter scores correspond to better visual acuity."|Baseline and Months 3, 6, 9 and 12|"Lens opacification analysis set with evaluable assessments at both baseline and the time point of interest in the same eye (as indicated by n). Three participants randomized to placebo who received at least 1 dose of denosumab in error are analyzed in the denosumab group."|||percentage of participants|||Number
2743823|NCT00925600|Other Pre-specified|Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12|"The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity.~Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline. A confirmed lens opacification event development or progression was defined as 2 directly subsequent events per protocol assessments at the same location (P, C, NO) using LOCS III as above."|12 months|"Lens opacification analysis set with at least two post-baseline LOCS III measurements by month 12.~Three participants randomized to placebo who received at least 1 dose of denosumab in error are analyzed in the denosumab group."|||percentage of participants|||Number
2743892|NCT00925522|Primary|Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.||7 days||||participants|||Number
2743824|NCT00925600|Other Pre-specified|Percentage of Participants With Lens Opacification Event Development or Progression by Month 6|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 6 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.|6 months|Lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site at or before month 6. Three participants randomized to placebo who received denosumab in error are analyzed in the denosumab group.|||percentage of participants|||Number
2743825|NCT00925600|Other Pre-specified|Percentage of Participant With Lens Opacification Event Development or Progression by Month 12 Based on a Change of ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III Score|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III score from baseline.|12 months|The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who eceived ≥ 1 dose of denosumab in error are analyzed in the denosumab group.|||percentage of participants|||Number
2743826|NCT00925600|Primary|Percentage of Participants With Lens Opacification Event Development or Progression by Month 12|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.|12 months|The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who received ≥ 1 dose of denosumab in error are analyzed in the denosumab group.|||percentage of participants|||Number
2743827|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Evaluation Period|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743828|NCT00925587|Secondary|Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)||Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||Weeks||Inter-Quartile Range|Median
2743829|NCT00925587|Secondary|Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743830|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743831|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743832|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743893|NCT00925353|Secondary|Frequencies of Moderate, Severe, or Life-threatening Side Effects|Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after|||||||
2743833|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743834|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743835|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743836|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743837|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743838|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743839|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743840|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743841|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743842|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743843|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743844|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
2743845|NCT00925587|Secondary|Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 29-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743914|NCT00925119|Primary|Change in Free Fatty Acid Kinetics|Estimate of peripheral lipolysis using modeling of free fatty acid levels collected during an IV glucose tolerance test. The change in threshold for insulin action (post-atenolol minus pre-atenolol) is the primary variable from this modeling that we analyzed.|Baseline and Week 8|Modeling data not available in all subjects|||mU/mL||Standard Deviation|Mean
2743847|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743848|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743849|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743850|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743851|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743852|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743853|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743854|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743855|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743856|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743857|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743858|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743859|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743860|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743861|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 1|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 1|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
2743862|NCT00925587|Secondary|Hb at Week 33||Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743863|NCT00925587|Secondary|Hb at Week 31||Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743864|NCT00925587|Secondary|Hb at Week 29||Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743865|NCT00925587|Secondary|Hb at Week 27||Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743866|NCT00925587|Secondary|Hb at Week 25||Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743867|NCT00925587|Secondary|Hb at Week 23||Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743868|NCT00925587|Secondary|Hb at Week 21||Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743869|NCT00925587|Secondary|Hb at Week 19||Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743870|NCT00925587|Secondary|Hb at Week 17||Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743871|NCT00925587|Secondary|Hb at Week 15||Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743872|NCT00925587|Secondary|Hb at Week 13||Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743873|NCT00925587|Secondary|Hb at Week 11||Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743874|NCT00925587|Secondary|Hb at Week 9||Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743875|NCT00925587|Secondary|Hb at Week 7||Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743876|NCT00925587|Secondary|Hb at Week 5||Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743877|NCT00925587|Secondary|Hb at Week 3||Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743878|NCT00925587|Secondary|Hb at Baseline||Baseline|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
2743879|NCT00925587|Secondary|Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.||Baseline to Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||Percentage of Participants||95% Confidence Interval|Number
2743915|NCT00925119|Primary|Change in Diastolic Function (Annular Tissue Velocity [Em])||8 weeks|Data were not able to be collected from the echocardiography.||||||
2743880|NCT00925587|Primary|Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)|The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.|Baseline Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||95% Confidence Interval|Least Squares Mean
2743881|NCT00925548|Secondary|Serum Carcinoma Antigen (CA) 15-3 Levels|CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.|Baseline, Week 5, 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743882|NCT00925548|Secondary|Number of Participant Utilizing Healthcare Resources|Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).|Randomization up to end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743883|NCT00925548|Secondary|European Questionnaire-5 Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743884|NCT00925548|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire|FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743885|NCT00925548|Secondary|Time to Chemotherapy|Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.|Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743886|NCT00925548|Secondary|Time to Progression (TTP)|TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).|Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).||||||
2743887|NCT00925548|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.|Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743888|NCT00925548|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743889|NCT00925548|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.|Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743890|NCT00925548|Secondary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
2743891|NCT00925548|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).||||||
2743894|NCT00925353|Secondary|Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.|Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after|||||||
2743895|NCT00925353|Secondary|EKG Changes|The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.|Prior to gel application and 3 hours after|||||||
2743896|NCT00925353|Primary|Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.|Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.|Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after|Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL.|||nanograms/mililiter|Participants|Full Range|Median
2743897|NCT00925301|Post-Hoc|Change From Baseline To Month 6 In Average Number Of Kidney IC GL-3 Inclusions|Renal biopsies were taken at Baseline and Month 6. The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images. Treatment effect was estimated using the LS mean difference between treatments within the context of the ANCOVA model.|Baseline, Month 6|ITT-amenable: Randomized participants with amenable mutations who received study drug during Stage 1. Amenable mutations are mutant forms of α Gal-A amenable to migalastat. Amenable mutations based on the GLP HEK assay. Participants were analyzed according to their original randomized treatment group.|||kidney IC GL-3 inclusions||Standard Deviation|Mean
2743898|NCT00925301|Other Pre-specified|Change From Month 6 To Month 12 In Average Number Of Kidney IC GL-3 Inclusions|Renal biopsies were taken at Month 6 and Month 12. The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Month 6 and Month 12. Assessments were made using digital images.|Month 6, Month 12|mITT with amenable mutations: Randomized participants who switched from placebo to migalastat during Stage 2, received at least 1 dose of study drug, and underwent a renal biopsy at both Baseline and Month 6. Amenable mutations are mutant forms of α-galactosidase A (α Gal-A) amenable to migalastat. Amenable mutations based on the GLP HEK assay.|||kidney IC GL-3 inclusions||95% Confidence Interval|Least Squares Mean
2743899|NCT00925301|Secondary|Change From Baseline Through Month 24 In Urine GL-3 Levels|The effect of migalastat versus placebo on urine GL-3 levels was measured by liquid chromatography-mass spectrometry/mass spectrometry. The 24-hour urine samples were collected at Baseline, Month 6 (Stage 1), Month 12 (Stage 2), and Month 24 (OLE). Results are presented as changes in nanograms (ng)/mg creatinine from Baseline to the end of the 3 stages.|Baseline, Months 6, 12, and 24|Stage 1: ITT, all randomized participants regardless of participation in the study beyond randomization. Stage 2: participants who completed Stage 1 and entered Stage 2. OLE: participants who completed Stage 2 and entered the optional OLE. Once assay and sample issues were identified, later samples were not further analyzed; all data was listed.|||ng/mg creatinine||Standard Deviation|Mean
2743900|NCT00925301|Secondary|Percent Change In Kidney IC GL-3 Inclusions From Baseline To Month 6|Renal biopsies were taken at Baseline and Month 6. The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images.|Baseline, Month 6|ITT: All randomized participants regardless of their participation in the study beyond randomization.|||percent change||Standard Deviation|Mean
2743916|NCT00925054|Other Pre-specified|Trough Concentration of BMN 165|Plasma concentrations of rAvPAL-PEG (BMN 165)|Baseline, Baseline/pre-dose, Week 7, and Week 16/Day 106|The PK population will consist of all subjects who received any amount of study drug and have post-treatment plasma BMN 165 concentration measurements.|||ng/mL||Standard Deviation|Mean
2743917|NCT00925054|Secondary|Percentage of Participants With Positive Anti-PAL-PEG IgE Antibodies|Antibody positivity over time|Baseline, Week 12|safety population|||Participants|||Count of Participants
2743918|NCT00925054|Secondary|Percentage of Participants With Positive PAL IgE Antibody|Antibody positivity over time|Baselline, Week 12|safety population|||Participants|||Count of Participants
2743919|NCT00925054|Secondary|Percentage of Participants With Positive Neutralizing Antibodies [NAb]|Antibody positivity over time|Baseline, Week 12|safety population|||Participants|||Count of Participants
2743920|NCT00925054|Secondary|Number of Participants With Positive PEG IgG Antibody|Antibody positivity over time|Baseline, Week 16|safety population|||Participants|||Count of Participants
2743901|NCT00925301|Primary|Percentage Of Participants With At Least A 50% Reduction From Baseline To Month 6 In The Average Number Of Kidney Interstitial Capillary (IC) Globotriaosylceramide (GL-3) Inclusions|Renal biopsies were taken at Baseline and Month 6 (Stage 1). The specimens were evaluated using virtual microscopy. The annotation, scoring, and adjudication of the kidney histology assessments were performed by the Clinical Pathology Endpoints Committee. The number of kidney IC GL-3 inclusions was assessed by 3 renal pathologists who were blinded to treatment assignments, participants' data, and biopsy sequence. One pathologist served as annotator and identified the 300 capillaries on up to 8 slides per specimen to be scored. Two pathologists served as scorers; these pathologists completed the blinded paired assessments. Each pathologist served as annotator/adjudicator for 1/3 of the cases. Paired assessments were undertaken at Baseline and Month 6. Assessments were made using digital images. A responder was defined as a participant with a ≥50% reduction from Baseline to Month 6 in the average number of kidney IC GL-3 inclusions.|Baseline, Month 6|ITT: All randomized participants regardless of their participation in the study beyond randomization. As per the statistical analysis plan, analysis excluded participants who were missing baseline kidney biopsy results.|||Participants|||Count of Participants
2743902|NCT00925288|Secondary|Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers|Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.|Month 0|All participants who listed doubts about the vaccine are counted here.|||participants|||Number
2743903|NCT00925288|Secondary|Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers|Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.|Baseline|All participants were included in the analysis for baseline HPV DNA prevalence|||participants|||Number
2743904|NCT00925288|Primary|Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.|Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.|6 months|All participants were included|||participants|||Number
2743905|NCT00925288|Primary|Antibody Response to HPV Vaccine for HPV 6,11,16,18.|We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.|Month 7|All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.|||Milli Merck Units||95% Confidence Interval|Geometric Mean
2743906|NCT00925132|Secondary|Phase 2 - Number of Participants With Disease Progression|Number of participants who died or had disease progression|5 years|Number patients who received study drug in Phase II portion of trial|||Participants|||Count of Participants
2743907|NCT00925132|Primary|Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria|"Tumor response rate was assessed using RECIST criteria in which a complete response was the disappearance of all target lesions; Partial response was a 30% decrease in the sum of the longest dimension (LD) of target lesions, relative to baseline measurement; Progressive disease was an increase of 20% or more in the sum of the LD of target lesions; and Stable disease was a decrease in tumor size of less than 30% or increase of less than 20%.~Tumor response rate was also assessed using CHOI's criteria in which a response was a 10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced computed tomography scan.~Tumor response rates were assessed in order to determine effectiveness of the treatment regimen which was defined by the response rate of at least 30% as measured by either the RECIST or Choi's criteria, and ineffective if the rate is less than 15% on both."|12 weeks (2 cycles)|Number of patients evaluable for tumor response assessment following 2 cycles of treatment|||Participants|||Count of Participants
2743908|NCT00925132|Primary|Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level|"A DLT was any Grade 4 toxicity for neutrophils or platelets for ≥ 7 days, Grade 3 toxicity for neutrophils for ≥ 21 days, any Grade 3 solid organ toxicity not explainable by another cause (e.g. neurotoxicity, GI toxicity), metabolic/laboratory toxicity (≥10 x ULN AST) for ≥ 14 days, any Grade 4 infection or QTcF> 500msec EKG. DLTs were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.~All adverse events were collected and graded to determine DLTs as assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. DLTs were assessed to determine the recommended Decitabine and Panobinostat dose for the Phase II portion of the trial."|6 weeks (one full cycle)|Number of patients within the 4 dosing cohorts evaluable for DLTs following administration of one full cycle|||Participants|||Count of Participants
2743909|NCT00925119|Secondary|Change in Insulin|fasting insulin (post - pre atenolol)|Baseline and Week 8||||mU/mL||Standard Deviation|Mean
2743910|NCT00925119|Secondary|Change in HDL||Baseline and Week 8||||mg/dL||Standard Deviation|Mean
2743911|NCT00925119|Secondary|Change in Glucose Effectiveness|Glucose effectiveness as measured by insulin-modified IV glucose tolerance test using the MINMOD model.|Baseline and Week 8|Data could not be determined because assumptions for MINMOD model were not met.||||||
2743912|NCT00925119|Secondary|Change in Insulin Sensitivity|"As measured by the Homeostatic model assessment of insulin resistance (HOMA2-IR) (post atenolol - pre atenolol).~he Homeostatic model assessment (HOMA) is a method for assessing insulin sensitivity from fasting glucose and insulin. A higher HOMA value indicates higher insulin resistance. The widely-used formulae available for HOMA1 provide only linear approximations of HOMA_%B and HOMA_IR, the inverse of HOMA_%S. These are: HOMA1_IR = [FPI (uU/ml) x FPG (mmol/l) ]/22.5 HOMA1_%B = (20 x FPI)/(FPG - 3.5) The results obtained for HOMA2 may differ considerably from HOMA1 computer-calculated values, especially for more extreme glucose and insulin values. For this reason, no attempt has been made to provide linear approximations of HOMA2 calculated values of HOMA_%B, HOMA_IR and HOMA_%S. The software needed to calculate HOMA2 values is available on this website: https://www.dtu.ox.ac.uk/homacalculator/download.php, subject to the conditions specified on the downloads page."|Baseline and Week 8|Post and Pre atenolol data available in 17 subjects|||arbitrary units||Standard Deviation|Mean
2743913|NCT00925119|Secondary|Change in Triglycerides|(Post atenolol triglycerides - Pre atenolol triglycerides)|Baseline and Week 8|Data available in 17 subjects|||mg/dL||Standard Deviation|Mean
2743924|NCT00925054|Secondary|Study Drug Related Adverse Events||Screening, Weeks 1-22|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, antibodies, and physical examinations).|||Participants|||Count of Participants
2743925|NCT00925054|Primary|Blood Phenylalanine Concentrations||Baseline, Week 1/Day 5, Week 7, Week 16/Day 106|Efficacy Population|||umol/L||Standard Deviation|Mean
2743926|NCT00925015|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|Approximately 4 weeks after last drug treatment (up to Day 293)|Participants treated with study medication.|||Participants|||Number
2743927|NCT00925015|Secondary|AUC0-24 of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The AUC0-24 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8 and 24 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2743928|NCT00925015|Secondary|Vss of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Vss of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/m^2||Geometric Coefficient of Variation|Geometric Mean
2743929|NCT00925015|Secondary|CL of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The CL of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/h/m^2||Geometric Coefficient of Variation|Geometric Mean
2743930|NCT00925015|Secondary|T1/2 of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The T1/2 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29..|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Geometric Coefficient of Variation|Geometric Mean
2743931|NCT00925015|Secondary|Cmax of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Cmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2743932|NCT00925015|Secondary|Tmax of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Tmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Full Range|Median
2743933|NCT00925015|Secondary|AUC0-168 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-168 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2743934|NCT00925015|Secondary|AUC0-24 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-24 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8 and 24 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2743935|NCT00925015|Secondary|Vss of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Vss of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/m^2||Geometric Coefficient of Variation|Geometric Mean
2743936|NCT00925015|Secondary|CL of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The CL of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mL/h/m^2||Geometric Coefficient of Variation|Geometric Mean
2743937|NCT00925015|Secondary|T1/2 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The T1/2 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Geometric Coefficient of Variation|Geometric Mean
2743938|NCT00925015|Secondary|Cmax of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Cmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2743939|NCT00925015|Secondary|Tmax of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Tmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Full Range|Median
2743940|NCT00925015|Secondary|Area Under the Concentration-time Curve From 0-168 Hours Post-dose (AUC0-168) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-168 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2743968|NCT00924807|Primary|Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|Day 29 and every 2 weeks|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."||||||
2743969|NCT00924781|Secondary|Change From Baseline in Hg Level at Week 12||12 weeks|Full analysis set; due to study termination participants in the MK2578 1mcg/350U QW and MK2578 1mcg/350U QM were not analyzed.|||g/dL||Standard Deviation|Mean
2743941|NCT00925015|Secondary|Area Under the Concentration-time Curve From 0-24 Hours Post-dose (AUC0-24) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-24 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8 and 24 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2743942|NCT00925015|Secondary|Steady-state Volume of Distribution (Vss) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Vss of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2743943|NCT00925015|Secondary|Clearance From Plasma (CL) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The CL of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mL/min/kg||Geometric Coefficient of Variation|Geometric Mean
2743944|NCT00925015|Secondary|Apparent Terminal Half-life (T1/2) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The T1/2 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Geometric Coefficient of Variation|Geometric Mean
2743945|NCT00925015|Secondary|Maximum Concentration (Cmax) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Cmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2743946|NCT00925015|Secondary|Concentration at the End of Infusion (Ceoi) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Ceoi of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2743947|NCT00925015|Secondary|Time to Maximum Concentration (Tmax) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone in or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Tmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Full Range|Median
2743948|NCT00925015|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|Sera were collected from participants prior to administration of the first dose of study drug, every 6 weeks during the study period, then 4 weeks, 8 weeks and 12 weeks post-treatment. A sandwich format enzyme-linked immunosorbent assay (ELISA) was used to detect the presence of HAHA in serum.|Up to 12 weeks after the last administration of dalotuzumab (up to 349 days)|All treated participants, excluding those without measurable data.|||Participants|||Number
2743970|NCT00924781|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||12 weeks|Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination.||||||
2743949|NCT00925015|Primary|Number of Dose-limiting Toxicities (DLTs)|To be declared a DLT an adverse experience had a causality related to study therapy. DLTs could be adverse experiences possibly, probably, or definitely related to study therapy by the Investigator, and included the following : Grade 4 neutropenia lasting >= 5 days; Grade 3 or 4 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except inadequately treated diarrhea, nausea and vomiting, rash, hyperglycemia, and transient abnormality of electrolytes. Anemia, infusion reactions, hypersensitivity reactions, and adverse experiences not-related to study therapy did not qualify as DLTs.|Four weeks of Cycle 1 treatment (up to 28 days)|Participants treated with study medication. The Dmab 10 mg/kg - Cetux/Irin arm was not evaluated. In the Cetux/Irin - Dmab 10 mg/kg (DDI) arm two participants were not analyzed because one had febrile neutropenia (Grade 3) before the first treatment, and the second had a skin toxicity (Grade 3) before the DLT evaluation period.|||DLT|||Number
2743950|NCT00924950|Secondary|Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion|Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.|6 Weeks|This outcome measure was not analyzed due to termination of the study||||||
2743951|NCT00924950|Primary|Change in Total Modified PASI Score at Week 4 Compared to Baseline|Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.|4 weeks|The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up.|||Units on a scale||95% Confidence Interval|Mean
2743952|NCT00924898|Secondary|Time to HIV RNA Suppression <50 Copies/mL|Number of days from ART initiation to HIV RNA suppression <50 copies/mL|Number of days from start of study treatment until HIV RNA suppression, assessed through week 96||||days||Full Range|Median
2743953|NCT00924898|Secondary|Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment|Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization|At enrollment||||Participants|||Count of Participants
2743954|NCT00924898|Secondary|Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications|Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization|At enrollment||||Participants|||Count of Participants
2743955|NCT00924898|Secondary|Number of Participants With HIV RNA Suppression at Week 96|Number of participants wtih HIV RNA level <50 copies/mL at week 96|HIV RNA level at 96 weeks following enrollment||||Participants|||Count of Participants
2743956|NCT00924898|Secondary|Number of Participants Without Virologic Failure at Week 48|HIV RNA level <50 copies/mL at week 48|HIV RNA level at week 48 following enrollment||||Participants|||Count of Participants
2743957|NCT00924898|Primary|Number of Participants Without Virologic Failure at Week 24|Number of participants with a HIV RNA level <200 copies/mL at week 24|HIV RNA level prior to or at week 24 following enrollment||||Participants|||Count of Participants
2743958|NCT00924833|Secondary|Mean 24 Hour/Daytime/Night-time Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
2743959|NCT00924833|Secondary|Sitting Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
2743960|NCT00924833|Secondary|Resting Energy Expenditure||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
2743961|NCT00924833|Primary|Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3.|"Difference in peak exercise minute ventilation between Time 1 and Time 3 (Time 3 - Time 1.~Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)."|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||L/min||Standard Deviation|Mean
2743962|NCT00924833|Secondary|Systolic Pulmonary Artery Pressure.||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
2743963|NCT00924833|Secondary|Peak Exercise Oxygen Saturation|Oxygen saturation by pulse oxymetry at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
2743964|NCT00924833|Primary|Peak Exercise Minute Ventilation|Minute ventilation at peak of exercise. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||L/min||Standard Deviation|Mean
2743965|NCT00924833|Primary|Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3|Difference in peak exercise oxygen consumption between Time 1 and Time 3 (Time 3 - Time 1)|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||ml/Kg/min||Standard Deviation|Mean
2743966|NCT00924833|Primary|Peak Exercise Oxygen Consumption|Oxygen consumption at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||ml/Kg/min||Standard Deviation|Mean
2743967|NCT00924807|Secondary|Biochemical Disease-free Survival|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|after 9 months|data not collected||||||
2743971|NCT00924781|Primary|Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia||12 weeks||||Participants|||Number
2743972|NCT00924781|Primary|Number of Participants With Composite Events of Infusion Reactions||12 weeks||||Participants|||Number
2743976|NCT00924729|Secondary|Disk Diffusion Assay of Collected Aqueous Humor|A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.|Approximately 3-4 months.|The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis||||||
2743977|NCT00924729|Primary|Aqueous Humor Concentration of Study Drug|Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.|approximately 3 to 4 months||||µg/ml||Standard Deviation|Mean
2743978|NCT00924651|Primary|Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)|"BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).~The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention)."|41 days: Day 0 (before intervention) Day 41 (post intervention)|Subjects completing both BFI at day 0 and day 41|||units on a scale||Standard Deviation|Mean
2743979|NCT00924638|Secondary|Impact of Patient Assistant Use on AF Diagnosis|AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency|Follow-up closure|Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study|||days from AF occurrence to AF diagnosis||Standard Deviation|Mean
2743980|NCT00924638|Secondary|Clinical Disease Burden and Care Pathway|Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months|12 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
2743981|NCT00924638|Secondary|Health Outcome as Evaluated by EQ-5D Questionnaire|EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).|12 months|Number of subjects who reported EQ-5D VAS score at the 12 months visit|||units on a scale of 0 to 100||Standard Deviation|Mean
2743982|NCT00924638|Secondary|Use of Antiarrhythmic Drugs|Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12 months follow-up visit|||percentage of participants|||Number
2743983|NCT00924638|Secondary|Use of Oral Anticoagulation (OAC) Drugs|Percentage of subjects who were using OAC drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12-months follow-up visit|||percentage of participants|||Number
2743984|NCT00924638|Secondary|Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)|Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
2743985|NCT00924638|Secondary|AF Detection Rate Within 12 Months|Percentage of subjects with AF detected within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
2743986|NCT00924638|Primary|AF Detection Rate Within 6 Months|Percentage of subjects with AF detected within 6 months of follow-up|6 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
2743987|NCT00924560|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.~A severe AE is defined as incapacitating, with inability to perform usual activities.~A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:~fatal or life-threatening;~required or prolonged inpatient hospitalization;~resulted in persistent or significant disability/incapacity;~congenital anomaly or birth defect;~important medical event."|12 months|The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety.|||participants|||Number
2743988|NCT00924560|Secondary|Change From Baseline in Serum Type I Collagen N-telopeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||nM bone collagen equivalents (BCE)||Standard Deviation|Mean
2743989|NCT00924560|Secondary|Change From Baseline in Serum Procollagen 1 N-terminal Propeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||µg/L||Standard Deviation|Mean
2743990|NCT00924560|Secondary|Change From Baseline in Serum Osteocalcin||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||nmol/L||Standard Deviation|Mean
2744188|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
2743993|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."|||g||Standard Error|Least Squares Mean
2743994|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."|||g/cm^2||Standard Error|Least Squares Mean
2743995|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."|||g||Standard Error|Least Squares Mean
2743996|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."|||g/cm^2||Standard Error|Least Squares Mean
2743997|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set|||g||Standard Error|Least Squares Mean
2743998|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set|||g/cm^2||Standard Error|Least Squares Mean
2743999|NCT00924560|Primary|Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)|"Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.~Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline * 100%."|Baseline and Month 12|Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations.|||percent change||Standard Error|Least Squares Mean
2744000|NCT00924508|Secondary|Number of Adverse Events Associated With Treatment||6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.|||Adverse events|||Number
2744001|NCT00924508|Primary|Change in Disease Severity: Percent Change in Mean EASI Score|Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.|Baseline, 6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.|||percentage change|Participants|Full Range|Mean
2744002|NCT00924482|Primary|Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements|"Correlation measured via Linear regression between thermodilution and ECOM, included as r^2 coefficient.~Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient.~ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely)."|perioperative period|Results are for the final n=101 who had the approved clinical electronics and clinical tube; no changes in tube, algorithm or electronic design were made during this part of the study. Experimental electronics and version of the tube were used to test and finalize the design and algorithm during enrollment of the earlier patient group.|||liters/min||Standard Deviation|Mean
2744003|NCT00924482|Secondary|Safety of Device Measured by Number of Participants With Adverse Events|Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements|perioperative period||||participants|||Number
2744004|NCT00924469|Primary|Dihydrotestosterone (DHT) Concentration in Prostate Tissue|The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
2744005|NCT00924469|Secondary|Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment|Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.||||||
2744125|NCT00923845|Secondary|Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen|Absolute neutrophil count determination by complete blood count methodology (Absolute Neutrophil Count (ANC) < 500 Cells/µL).|During the 21-day PC regimen||||Participants|||Count of Participants
2744006|NCT00924469|Secondary|Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24|Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.||||||
2744007|NCT00924469|Secondary|Percentage of Participants With Pathologic Complete Response (CR)|Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Percentage of participants|||Number
2744008|NCT00924469|Secondary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.|Weeks 12 and 24|ITT population included all the participants who were randomly assigned to the study treatment.|||Percentage of participants|||Number
2744009|NCT00924469|Secondary|Serum Levels of Androgens|Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Nanogram per deciliter (ng/dL)||Standard Deviation|Mean
2744010|NCT00924469|Secondary|Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue|Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
2744011|NCT00924469|Secondary|Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
2744012|NCT00924469|Primary|Testosterone Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
2744013|NCT00924443|Secondary|Duration of Complete Remission|Duration was calculated by Kaplan- Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only|||days||95% Confidence Interval|Median
2744014|NCT00924443|Secondary|Overall Survival|Calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.|||days||95% Confidence Interval|Median
2744015|NCT00924443|Secondary|Duration of Overall Response|Duration was calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only|||days||95% Confidence Interval|Median
2744016|NCT00924443|Secondary|Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)|"Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.~Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.|||percent of participants||95% Confidence Interval|Number
2744026|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I)|The MTD of ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) when given in combination with dasatinib (taken daily, continuously) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.|||mg/m2|||Number
2744017|NCT00924443|Primary|Overall Response Rate (ORR)|"ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.~ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.|||percentage of participants||95% Confidence Interval|Number
2744018|NCT00924404|Secondary|Mean Number of Antibiotic Courses During the Study Period|Mean Number of antibiotic courses for infection during the study period|12 weeks||||mean number of antibiotic courses during||Standard Deviation|Mean
2744019|NCT00924404|Primary|SNOT-20 Scores at 12 Weeks|"Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues.~Symptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent as troublesome as possible. The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100."|12 weeks|We initially enrolled 53 subjects but we had 10 subjects drop out of the study.|||units on a scale||Standard Deviation|Mean
2744020|NCT00924352|Primary|Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||months||95% Confidence Interval|Median
2744021|NCT00924352|Secondary|Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||participants|||Number
2744022|NCT00924352|Secondary|Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||participants|||Number
2744023|NCT00924352|Secondary|Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II)|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks (from the start of treatment) plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.||||percentage of participants|||Number
2744024|NCT00924352|Secondary|Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||participants|||Number
2744025|NCT00924352|Primary|Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose limiting toxicity was defined as any grade 4 hematologic event or any grade 3 or 4 non-hematologic event occurring during cycle 1 that is attributable to dasatinib, ixabepilone, or the combination. The following events were excluded from this definition: grade 4 neutropenia lasting for 3 days or less; grade 3 nausea responsive to antiemetics; grade 3 infection with normal ANC or grade 1 or 2 neutrophils; grade 3 diarrhea responsive to optimal use of antidiarrheal therapy.|DLTs were assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.|||participants|||Number
2744039|NCT00924287|Secondary|Number of Participants With In Vivo Survival of Transfused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|12 days||||Participants|||Number
2744040|NCT00924287|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 days||||Participants|||Number
2744027|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)|The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.|||mg daily|||Number
2744028|NCT00924326|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 101 months and 17 days.||||Participants|||Count of Participants
2744029|NCT00924326|Primary|Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma|Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years|1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat Arm/Group: “3 participants in group 1 (1x10e9-1x10e10 cells/kg + high-dose IL2)) initially responded but were then retreated in group 2 after progression.”|||Participants|||Count of Participants
2744030|NCT00924313|Secondary|11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation|Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.|2 years|One patient was not imaged because of failed tracer synthesis.|||SUVmax||Standard Deviation|Mean
2744031|NCT00924313|Secondary|Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI.|PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.|2 years|One patient was not imaged because of failed tracer synthesis.|||percentage of sensitivity||95% Confidence Interval|Number
2744032|NCT00924313|Secondary|Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score|Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk.|2 years|One patient was not imaged because of failed tracer synthesis.|||SUV||Standard Deviation|Mean
2744033|NCT00924313|Secondary|Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection|Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician.|2 years|One patient was not imaged because of failed tracer synthesis.|||Participants|||Count of Participants
2744034|NCT00924313|Secondary|Count of Participants With Physiological Effects of [11C]AC|Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis.|2 years|One patient was not imaged because of failed tracer synthesis.|||Participants|||Count of Participants
2744035|NCT00924313|Secondary|Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging|Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).|2 years|One patient was not imaged because of failed tracer synthesis.|||SUV||Standard Deviation|Mean
2744036|NCT00924313|Secondary|Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm|The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities.|2 years|One patient was not imaged because of failed tracer synthesis.|||Percentage ROC curve||95% Confidence Interval|Number
2744037|NCT00924313|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years||||Participants|||Count of Participants
2744038|NCT00924313|Primary|Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate|Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.|2 years|One patient was not imaged because of failed tracer synthesis.|||ng/mL||Standard Deviation|Mean
2744041|NCT00924287|Primary|Number of Participants With an Objective Clinical Tumor Regression Response|Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 days|||||||
2744042|NCT00924209|Secondary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|The time between the first day of treatment to the day of death|No goals were met because of low accrual for which the study was closed.||||||
2744043|NCT00924209|Secondary|Median Survival|Median survival is the length of time a participant lives with disease following treatment.|Length of time a participant lives with disease following treatment|No goals were met because of low accrual for which the study was closed.||||||
2744044|NCT00924209|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the time between the first day of treatment to the day of disease progression. Progression will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|The time between the first day of treatment to the day of disease progression|No goals were met because of low accrual for which the study was closed.||||||
2744045|NCT00924209|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 38 months||||Participants|||Count of Participants
2744046|NCT00924209|Primary|Rate of Pathologic Complete Response|Complete response is defined as a disappearance of all target lesions and was assessed by the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.|25 weeks|No goals were met because of low accrual for which the study was closed.||||||
2744047|NCT00924170|Secondary|Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2|Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 12 days|*Grade 5 (death) event. Data for this outcome measure is reported as in the publication noted in the References module.|||Participants|||Count of Participants
2744048|NCT00924170|Secondary|Count of Participants With Grades 3-5 Adverse Events of > 1 Adult T-Cell Leukemia (ATL) Patients Treated With 20+200, 25+250, and 30+300 mg/m^2 LMB-2/Fludarabine and Cyclophosphamide|Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 (mild), Grade 4 (life threatening) and Grade 5 (death).|7 years and 12 days|Data for this outcome measure is reported as in the publication noted in the References module.|||Participants|||Count of Participants
2744049|NCT00924170|Secondary|Half Life (t1/2) of LMB-2|Dilutions of patient plasma was tested by cytotoxicity assays to determine half life. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||min||Full Range|Median
2744050|NCT00924170|Secondary|Volume of Distribution of LMB-2|Dilutions of patient plasma were tested by cytotoxicity assays to determine volume of distribution of LMB-2. Volume distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. This was measured during the first 24 hours after administration of the dose on cycle 2 day 1.|24 hours|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||Liters||Full Range|Median
2744051|NCT00924170|Secondary|Plasma Clearance (CL) of LMB-2|Dilutions of patient plasma was tested by cytotoxicity assays to determine plasma clearance of LMB-2.The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||mL/min||Full Range|Median
2744080|NCT00924040|Secondary|Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25|CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered <3 ng/ml for sCD25, and <2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.|patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR||||Percentage of participants|||Number
2744052|NCT00924170|Secondary|Duration of Response (Complete Response + Partial Response)|Duration of response is defined as a response lasting for at least 4 weeks but >8 weeks and is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|69 months||||Weeks||95% Confidence Interval|Median
2744053|NCT00924170|Secondary|Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2|Blood was drawn prior to each cycle of LMB-2 to determine if the level, >75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||percentage of participants||95% Confidence Interval|Number
2744054|NCT00924170|Secondary|Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry|Peripheral blood was obtained and analyzed by flow cytometry.|First 24 hours after the dose given on Cycle 2, day 1|One patient did not have flow cytometry measuring it.|||Cells/µL||Full Range|Median
2744055|NCT00924170|Secondary|Area Under the Plasma Concentration (AUC) - LMB2|AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||µg/-min/mL||Full Range|Median
2744056|NCT00924170|Secondary|Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders|Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|First 24 hours after the dose given on Cycle 2, day 1|The number 8 represents the number of responders in the Arm/Group and the number 2 represents the number of non-responders in the Arm/Group.|||pg/ml||Full Range|Median
2744057|NCT00924170|Secondary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to <grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to <grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting <2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment.|30 days after last dose of LMB2||||Participants|||Count of Participants
2744058|NCT00924170|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 12 days||||Participants|||Count of Participants
2744059|NCT00924170|Secondary|Overall Survival (OS)|OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|70 months|One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.|||Months||95% Confidence Interval|Median
2744060|NCT00924170|Secondary|Progression Free Survival (PFS)|PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|70 months||||Months||95% Confidence Interval|Median
2744061|NCT00924170|Secondary|Peak Level of LMB-2 in Adult T-Cell Lymphoma|The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve.|First 24 hours after the dose given on Cycle 2, day 1||||ng/mL||Full Range|Median
2744081|NCT00924040|Secondary|Number of Patients With ex Vivo Sensitivity Who Respond Clinically|Although some hairy cell leukemia (HCL) cells from some patients may have ex vivo sensitivity, they might not respond clinically. Number of participants with pretreatment ex vivo sensitivity (<10 ng/ml IC50) who go on to achieve CR as best response. CR required abscence of HCL in the bone marrow and resolution of cytopenias.|Time to CR can be between 2 months and 1 year||||Participants|||Number
2744082|NCT00924040|Secondary|Number of Patients Who Developed Neutralizing Antibodies After One or More Cycles of BL22|Fresh malignant cells are isolated from blood, bone marrow, lymph nodes or other tissue and incubated with recombinant immunotoxins to determine sensitivity to BL22 and other agents to estimate the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|24 weeks||||Participants|||Number
2744062|NCT00924170|Primary|Percentage of Participants With a Minimally Durable Clinical Response Rate|Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma and must last >8 weeks to meet the primary endpoint of the study. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|8 weeks|"All 10 patients receiving LMB-2 and at least 25+250 mg/m^2 Fludarabine/Cyclophosphamide (FC) were evaluable for response.~Of the 8 other patients, only 5 received LMB-2 and were therefore evaluable for response."|||percentage of participants||95% Confidence Interval|Number
2744063|NCT00924118|Secondary|Left Ventricular Infarct Size|Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.|4-5 days following enrollment|Only 2 participants from each arm underwent MRI imaging. Too few subjects underwent MRI imaging to make a statistical comparison. Only those where data was obtained has been reported.|||infarct percentage of left ventricle||Full Range|Mean
2744064|NCT00924118|Primary|Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.|Measured as percentage of left ventricle|4-5 days from enrollment|Sestamibi imaging proved impossible to obtain emergently and therefore no data was collected.||||||
2744065|NCT00924066|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 61 months|Adverse events are grouped together because the histology cohort has no bearing on the adverse events.|||Participants|||Count of Participants
2744066|NCT00924066|Primary|Number of Participants With a Tumor Response (PR + CR) Per RECIST|Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.|Every 6 weeks, up to 15 months||||Participants|||Count of Participants
2744067|NCT00924053|Primary|Vz/F|Apparent volume of distribution|3 days||||mL||Standard Deviation|Mean
2744068|NCT00924053|Primary|CL/F|The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.|3 days||||mL/hr||Standard Deviation|Mean
2744069|NCT00924053|Primary|t1/2|Apparent terminal half life|3 days||||hour||Standard Deviation|Mean
2744070|NCT00924053|Primary|λz|Terminal phase rate constant|3 days||||1/hour||Standard Deviation|Mean
2744071|NCT00924053|Primary|Tmax|Time of maximum plasma concentration|3 days||||hour||Full Range|Median
2744072|NCT00924053|Primary|Cmax|Maximum plasma concentration|3 days||||ng/mL||Standard Deviation|Mean
2744073|NCT00924053|Primary|AUC Inf|Area under the plasma concentration-time curve from time 0 to infinity|3 days||||ng*hr/mL||Standard Deviation|Mean
2744074|NCT00924053|Primary|AUC0-24|Area under the plasma concentration-time curve from time 0 to hour 24|3 days||||ng*hr/mL||Standard Deviation|Mean
2744075|NCT00924053|Primary|AUC 0-t|Area under the plasma concentration-time curve from time 0 to time t|3 days||||ng*hr/mL||Standard Deviation|Mean
2744076|NCT00924053|Primary|Safety and Tolerability of EGT0001474|Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.|25 days|All patients who took study medication were included in the analysis.|||Events|||Number
2744077|NCT00924040|Secondary|Percentage of Patients Who Have Dose Limiting Toxicity (DLT)|Determination of dose limiting toxicity (DLT) is by the standard toxicity assessment Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0) done every cycle. For detailed information about the CTCAEv3.0 see the protocol Link module.|24 weeks||||Percentage of participants|||Number
2744078|NCT00924040|Secondary|Percentage of Patients Who Make Antibodies|Determination of antibodies against BL22 is determined by the Clinical Laboratory Improvement Amendments (CLIA) certified blood tests in our contract lab. NCI-Frederick in the laboratory of Dr. David Waters (Science Applications International Corporation (SAIC). He is CLIA certified.|24 weeks||||Percentage of participants|||Number
2744079|NCT00924040|Secondary|Correlation Between Number of Prior Cycles of BL22 With Immunogenicity on This Protocol|Percent of patients neutralizing >75% of 1000 ng/ml of BL22 in a biologic assay by end of treatment, with respect to the number of prior cycles of BL22 prior to entry on this protocol|Within 2 months of end of treatment ( measure antibodies before each cycle)||||correlation coefficient|||Number
2744097|NCT00923949|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|58 days||||Participants|||Number
2744286|NCT00922974|Secondary|Median Duration of Pain Response (Phase III)||Baseline to 24 months||2021-04-30|04/2021||||
2744083|NCT00924040|Secondary|Number of Participants With Complete Response (CR) Who Resolve the Bone Marrow Abnormality by Magnetic Resonance Imaging (MRI)|Patients are assessed by MRI to determine which ones resolve their marrow abnormality. A non-parametric Wilcoxon test was to be used to determine whether CR correlated with resolution of MRI abnormality|Bone marrow biopsy and MRI 4 weeks after patients meeting blood criteria for CR, and if CR is present, repeat bone marrow biopsy and MRI every 12 months. Bone marrow biopsy and MRI is not done in patients with PR as best response.||||Participants|||Number
2744084|NCT00924040|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years & 6 months||||Participants|||Number
2744085|NCT00924040|Primary|Number of Months to Response to Treatment|Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils >/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.|2/14/2009 till 6/24/2010||||Months|||Number
2744086|NCT00924001|Secondary|Number of Participiants With In-vivo Survival of Infused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|44 days||||Participants|||Number
2744087|NCT00924001|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|44 days||||Participants|||Number
2744088|NCT00924001|Primary|Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|44 days||||Participants|||Number
2744089|NCT00923975|Primary|Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks|"Study staff rated participants on their success at performing specific tasks. The rating scale was:~= Successful ( no assistance)~= Successful after staff prompted to view user instructions~= Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call)~= Unsuccessful (Subject could not perform the task)~= Subject could not perform task due to software or hardware failure after repeated attempt."|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.|||participants|||Number
2744090|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)|"Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale:~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.|||participants|||Number
2744091|NCT00923975|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)|"After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale.~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|The number of results analyzed was less than 50 because some subjects had no opinion. One subject had no opinion of clarity of online help overall and three subjects had no opinion of usefulness of online help overall.|||participants|||Number
2744092|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:~= Very Simple~= Simple~= Neither Simple nor Difficult~= Difficult~= Very Difficult"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.|||participants|||Number
2744093|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Serum Tumor Markers|C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
2744094|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers|ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
2744095|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers|Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
2744096|NCT00923949|Secondary|Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)|Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
2744098|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor|Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
2744099|NCT00923949|Primary|Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue|Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
2744100|NCT00923936|Secondary|Percentage of Participants With 12- Month Progression-free Survival (PFS)|Participants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities.|12 months||||percentage of participants||95% Confidence Interval|Number
2744101|NCT00923936|Secondary|Median Number of Cycles Need to Obtain a Partial Response|Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks.|6 cycles, an average of 18 weeks||||Cycles||95% Confidence Interval|Median
2744102|NCT00923936|Secondary|Count of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 6 months and 21 days||||Participants|||Count of Participants
2744103|NCT00923936|Secondary|Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab|Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response.|6 cycles, an average of 18 weeks|No patients had a complete response.|||percentage of participants||80% Confidence Interval|Number
2744104|NCT00923936|Primary|Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.|Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) & noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.|6 cycles, an average of 18 weeks||||percentage of participants||80% Confidence Interval|Number
2744105|NCT00923910|Secondary|Number of Participants With Progressive Disease|Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions (i.e. tumor response). Response criteria for acute leukemia's is worse marrow classification (i.e., M status) with at least a 50% increase in the percentage of marrow blasts, or no change in marrow classification (i.e., M status), but a 50% or greater increase in absolute peripheral blast count or extent of medullary disease|4 to12 weeks|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
2744119|NCT00923845|Secondary|Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).|100 days post transplant||||Participants|||Count of Participants
2744106|NCT00923910|Secondary|Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)|KLH is a neoantigen known to induce helper response was used concurrently as a vaccine adjuvant and control antigen. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
2744107|NCT00923910|Secondary|Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)|WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
2744108|NCT00923910|Secondary|Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)|WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
2744109|NCT00923910|Secondary|Time to Immune Response|Immune response was monitored by use of interferon gamma Enzyme-Linked Immunospot (ELISpot) and by delayed-type hypersensitivity (DTH) testing.|4 to 12 weeks|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||Weeks|||Number
2744110|NCT00923910|Primary|Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3|Acute Graft versus Host Disease (GVHD) was graded by the modified Glucksberg scale. 0 = no GVHD normal, 4 = severe GVHD.|28 days following completion of last vaccine and/or DLI (donor lymphocyte infusion) administration|Data for the frequency and severity of GVHD was captured as an endpoint for this trial. The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
2744111|NCT00923910|Primary|Toxicity|Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.|21 months|Only recipients were monitored for adverse events.|||participants|||Number
2744112|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))|CD4+ T cells were analyzed by flow cytometry for intracellular expression of FoxP3.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4+ T cells||Full Range|Median
2744113|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet|CD4+ T cells were analyzed by flow cytometry for intracellular detection of Tbet transcription factor.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4+T cells||Full Range|Median
2744114|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)|Intra-cellular flow cytometry detection of GATA3 transcription factor.|Days 14, 60 and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4+ T cells||Full Range|Median
2744115|NCT00923845|Secondary|Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution|CD8+ T Cells immune reconstitution is defined as distribution of CD8+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percent of total CD8 cell subsets||Standard Deviation|Median
2744116|NCT00923845|Secondary|Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution|CD4 T Cells immune reconstitution is defined as distribution of CD4+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4 cell subsets||Standard Deviation|Median
2744117|NCT00923845|Secondary|Count of Patients With Chronic Graft Versus Host Disease (GVHD)|Chronic GVHD was assessed by the 2005 Chronic GVHD Consensus Project. Chronic GVHS may include dryness of the mouth and eyes, weight loss, liver damage and lung damage leading to cough and shortness of breath (i.e. skin Grading: no symptoms = 0, <18% body surface area (BSA) = 1, 19-50% BSA = 2, and >50% BSA = 3); oral cavity Grading: no symptoms = 0, mild symptoms = 1, moderate symptoms =2 and severe symptoms =3)).|For the duration of post-transplant follow-up|Only 4 patients were evaluable due to mortality from malignancy.|||Participants|||Count of Participants
2744118|NCT00923845|Secondary|Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).|100 days post-transplant through 5 years post-transplant|Only 6 patients were evaluable for this endpoint due to death due to malignancy.|||Participants|||Count of Participants
2744120|NCT00923845|Secondary|Engraftment Donor T Cell and Myeloid Cell Chimerism|Donor Genetic Elements by variable number tandem repeat-polymerase chain reaction (VNTR-PCR) Analysis.|Days 14, 28, 45, and 60 post transplant||||Percent Donor by VNTR-PCR Analysis||Full Range|Median
2744126|NCT00923845|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|50 months and 6 days||||Participants|||Count of Participants
2744127|NCT00923845|Primary|Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))|Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.|6 Months Post-Transplant (Day +100)||||participants|||Number
2744128|NCT00923598|Primary|Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC)|A device was used called a dynamometer to measure the force during maximum voluntary isometric contraction. The dynamometer was placed on ipsilateral anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the quadriceps, maintain this effort for 5 seconds, and then relax.|morning of postoperative day 2|Patients undergoing bilateral knee replacements|||newtons||Standard Deviation|Mean
2744129|NCT00923481|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|23 months||||Participants|||Number
2744130|NCT00923481|Primary|Response Rate|Response is assessed by the RECIST (response criteria in solid tumors)criteria. A complete response (CR) is disappearance of all target lesions , partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|24 months||||Participants|||Number
2744131|NCT00923364|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately, 91 months|Data were not collected separately for donors and recipients.|||Participants|||Count of Participants
2744132|NCT00923364|Secondary|Number of Participants With Disease Free Survival|Number of participants with documented evidence of disease progression following start of treatment.|2 years|10/19 analyzed:5pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||Participants|||Count of Participants
2744133|NCT00923364|Secondary|Overall Survival|Overall survival is defined as date of on-study to date of death from any cause or last follow up.|2 years|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||months||Full Range|Median
2744134|NCT00923364|Secondary|Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)|Acute GVHD is assessed according to the 1994 Consensus Conference Grading Criteria. Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. GVHD can affect performance status and attack multiple organ systems such as the skin, liver, gut, mouth, eyes, joints, lung, etc. that can lead to a rash, diarrhea, metabolic changes, infection and/or death. The clinical grading of acute GVHD is grade 0 (none) to 4 (severe). Chronic GVHD is a delayed form of GVHD that may occur after day 100 post transplant.|2 years|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||participants|||Number
2744135|NCT00923364|Secondary|Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)|Engraftment of donor cells was assessed using polymorphisms in regions known to contain short tandem repeats. Peripheral blood cluster of differentiation 14 (CD14+), cluster of differentiation 3 (CD3-)/cluster of differentiation 56 (CD56+), cluster of differentiation 19 (CD19+), and CD3+ subsets were isolated by flow cytometry and chimerism was assessed.|2 years|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||percentage of donor cells||Full Range|Mean
2744136|NCT00923364|Primary|Days to Platelet Engraftment|Platelet engraftment is defined as a platelet count of >20 x 10(9) cells/L for 7 consecutive days without requiring a platelet transfusion.|30 days|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||Days||Full Range|Median
2744137|NCT00923364|Primary|Days to Neutrophil Engraftment|Neutrophil engraftment is defined as a neutrophil count of >0.5 x 10(9) cells/L for 3 consecutive days.|30 days|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||Days||Full Range|Median
2744138|NCT00923351|Primary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|Time between the first day of treatment to the day of death or at the conclusion of 5 years of follow-up, whichever comes first, assessed up to approximately 11 years.||||years||Full Range|Median
2744139|NCT00923351|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 49.5 months||||Participants|||Count of Participants
2744159|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||μg/mL||Standard Deviation|Mean
2744160|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal||||μg/mL||Standard Deviation|Mean
2744287|NCT00922974|Secondary|Median Time to Pain Response (Phase III)||Baseline to 24 months||2021-04-30|04/2021||||
2744140|NCT00923351|Primary|Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay|"A positive response to the tumor vaccine requires a positive reaction in at least one of the two assays below (immune responses to tumor lysates using ex vivo and delayed type of hypersensitivity (DTH).~The presence of a positive delayed type of hypersensitivity (DTH) reaction to the tumor lysate in a patient who did not show a positive DTH reaction prior to immunotherapy. A positive reaction is induration of at least 0.5 cm.~Immunotherapy administered to patients with recurrent or metastatic pediatric solid tumors such as Ewing's sarcoma, rhabdomyosarcoma, or neuroblastoma. Each vaccine is given as 6 separate injections. Three intradermal on one arm or leg and three subcutaneous on the other arm or leg."|Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (± 7 days) (Arm B)|Five of the original six participants from Arm A were analyzed because one subject was changed to a special exemption.|||Participants|||Count of Participants
2744141|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sirolimus|The phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks||||mg/m^2|||Number
2744142|NCT00923273|Primary|Phase II: Clinical Response Rate|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|21 weeks|By formal criteria in the protocol, DL4 exceeds the MTD, and DL 3 would be expanded by 3 subjects to confirm it's tolerability. We believe that DL4 is safe, and that the observed DLTs at this DL are related to enrollment of a subject with a borderline performance status, and the omission of defining length of neutropenia as a DLT.|||Participants|||Count of Participants
2744143|NCT00923273|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 45 months||||Participants|||Count of Participants
2744144|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed|The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks||||mg/m^2|||Number
2744145|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||ng/ml||Standard Deviation|Mean
2744146|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||ng/ml||Standard Deviation|Mean
2744147|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||ng/ml||Standard Deviation|Mean
2744148|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||ng/ml||Standard Deviation|Mean
2744149|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||ng/ml||Standard Deviation|Mean
2744150|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||ng/ml||Standard Deviation|Mean
2744151|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||ng/ml||Standard Error|Mean
2744152|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||ng/ml||Standard Deviation|Mean
2744153|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||pg/ml||Standard Deviation|Mean
2744154|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|6 months||||pg/ml||Standard Deviation|Mean
2744155|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||pg/ml||Standard Deviation|Mean
2744156|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||pg/ml||Standard Deviation|Mean
2744157|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|1 year||||μg/mL||Standard Deviation|Mean
2744158|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||μg/mL||Standard Deviation|Mean
2744189|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
2744190|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
2744191|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
2744192|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
2744193|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mmHg||Standard Deviation|Mean
2744194|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mmHg||Standard Deviation|Mean
2744195|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mmHg||Standard Deviation|Mean
2744196|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mmHg||Standard Deviation|Mean
2744197|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mmHg||Standard Deviation|Mean
2744198|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mmHg||Standard Deviation|Mean
2744199|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mmHg||Standard Deviation|Mean
2744200|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mmHg||Standard Deviation|Mean
2744201|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mmHg||Standard Deviation|Mean
2744202|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mmHg||Standard Deviation|Mean
2744203|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||Kg/m2||Standard Deviation|Mean
2744204|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||Kg/m2||Standard Deviation|Mean
2744205|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||Kg/m2||Standard Deviation|Mean
2744206|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||Kg/m2||Standard Deviation|Median
2744207|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal||||pg/ml||Standard Deviation|Mean
2744208|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||Kg/m2||Standard Deviation|Mean
2744209|NCT00923247|Secondary|Comparison of Steady State Vandetanib Exposure With Relevant Literature Values|"Because vandetanib PK exposure was only measured during a single 8-hr window during daily dosing, the only comparison to assess the effect of bortezomib is to compare these values to published literature."|Cycle 3 day 1 (an average of 60 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|Vandetanib PK samples were only obtained during the phase 1 portion of the study during cycle 3, day 1, where patients received both vandetanib (at steady-state) and bortezomib. “13/14 patients analyzed on day 61 (C3D1). Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||ng/mL/mg||Standard Deviation|Mean
2744210|NCT00923247|Secondary|Bortezomib Volume of Distribution (Vss)|Vss represents the volume into which the drug distributes into once given to the patient at steady-state. This volume parameter provides a measure of where in the body the drug is going, based on fluid volume.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||Liter||95% Confidence Interval|Geometric Mean
2744211|NCT00923247|Secondary|Total Systemic Clearance (CL) of Bortezomib|Total systemic clearance = dose/area under curve extrapolated to infinity (AUCinf.). This measurement represents the rate at which plasma is systematically cleared of drug.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||L/hr||95% Confidence Interval|Geometric Mean
2744212|NCT00923247|Secondary|Terminal Half-Life (T1/2) of Bortezomib|The time it takes for the measured concentration of the drug to drop by half.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||hour||95% Confidence Interval|Geometric Mean
2744213|NCT00923247|Secondary|Area Under the Bortezomib Plasma Concentration Versus Time Curve From Time Zero to Infinity/Dose (AUCinf/D)|The area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) was calculated using the linear up-log down trapezoidal method via extrapolation of AUC(LAST) (AUC to the last quantifiable time point) by dividing C(LAST) (the last measurable drug concentration, typically at 24 hour post-dose) by the rate constant of the terminal phase, lambda z. This constant was determined from the slope of the terminal phase of the concentration-time curve using weighted least-squares as the estimation procedure.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|PK samples were only done during the phase I portion of the study. “7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.” Please see other outcome measure modules for details.|||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
2744214|NCT00923247|Secondary|Maximum Bortezomib Plasma Concentration Normalized to Dose (Cmax/D)|Geometric mean for Bortezomib pharmacokinetic (PK) parameters both before (cycle 1 day 1) and during steady-state Vandetanib (cycle 3 day 1; exposures are dose normalized). Bortezomib plasma concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification (LLOQ) of 1 ng/mL. Only measured concentrations above the LLOQ were used in the calculation of PK parameters. The maximum plasma concentration (Cmax) was recorded as observed values.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose, 1, 2,4, 6, 8, 10 and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2744215|NCT00923247|Secondary|Percentage of Participants With a Change in Consistency in Tumor-Related Diarrhea Compared to Baseline|Baseline stool consistency (formed, loose or partially formed, watery) will be the consistency most frequently observed during a 7-day period immediately prior to starting vandetanib. Complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.|Baseline, and for a period of at least 4 weeks post study drug administration|This outcome measure was not analyzed because the number of patients eligible for this response is 0, in both the Phase I and Phase II cohorts. None of the participants met the criteria of >=5 watery stools per day at baseline. No participants were enrolled in the phase IIB cohort.||||||
2744216|NCT00923247|Secondary|Percentage of Participants With a Change in Frequency in Tumor-Related Diarrhea Compared to Baseline|Complete response is an average of 0-2 formed stools per day for a period of at least 4 weeks. partial response is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.|Baseline, and for a period of at least 4 weeks post study drug administration|This outcome measure was not analyzed because no participant had a baseline diarrhea that met the criteria for analysis. They needed to have diarrhea 5 times a day for several days in a row and no one had the baseline problem.||||||
2744217|NCT00923247|Secondary|Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response|Carcinoembryonic Antigen (CEA) was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CEA level following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CEA relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Stable disease is <50% increase or decrease in CEA level relative to the baseline level.|4 weeks|No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CEA levels that are >2 times the upper limit of normal are evaluable for biomarker response. There were 14 participants that met this criteria.|||Participants|||Count of Participants
2744218|NCT00923247|Secondary|Number of Participants With Tumor Biomarker Calcitonin (CTN) Response|Calcitonin was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CTN level following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CTN level relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CTN relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Stable disease is <50% increase or decrease in CTN level relative to the baseline level.|4 weeks|No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CTN levels that are >2 times the upper limit of normal are evaluable for biomarker response. There were 16 participants that met this criteria.|||Participants|||Count of Participants
2744219|NCT00923247|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 7 years and 9 days|No participants were enrolled in the phase IIB cohort.|||Participants|||Count of Participants
2744220|NCT00923247|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the duration of time from start of treatment to time of progression. Comparison of PFS between cohorts 1, 2A and 2B was to be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2-3 years|A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.|||Months||Full Range|Median
2744299|NCT00922766|Primary|Number of Participants With Minor Bleeding Events|Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
2744221|NCT00923247|Secondary|Response Rate (Complete Response (CR) + Partial Response (PR) of Adults With a Diagnosis of MTC Treated With Either of Two Regimens: (1) Daily Oral Vandetanib and Bortezomib or (2) Daily Oral Vandetanib|Comparison of response between cohorts 1, 2A and 2B was to be determined by computed tomography scan reviews using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|2-3 years|A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.|||Participants|||Count of Participants
2744222|NCT00923247|Primary|Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib|"Progression free survival is defined as the duration of time from start of treatment to time of progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator)."|4 months|No participants were enrolled in the phase IIB cohort. One participant was in cohort 2A, thus standard deviation could not be calculated.|||months||Standard Deviation|Median
2744223|NCT00923247|Primary|Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|4 months|No participants were enrolled in the phase IIB cohort.|||Participants|||Count of Participants
2744224|NCT00923247|Primary|Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib|A maximum tolerated dose for bortezomib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.|80 days||||mg/m^2|||Number
2744225|NCT00923247|Primary|Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib|A maximum tolerated dose for vandetanib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.|80 days||||mg|||Number
2744226|NCT00923195|Secondary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|32 months||||Participants|||Number
2744227|NCT00923195|Primary|Complete Response Rates for Patients With Metastatic Melanoma|Complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is a disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|Every 4-6 weeks after initial treatment regimen. If the patient has stable disease or tumor shrinkage, complete evaluations will be repeated every 1-3 months.||||Participants|||Number
2744228|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hour||Standard Deviation|Mean
2744229|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
2744230|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
2744301|NCT00922766|Primary|Number of Participants With Death or Myocardial Infarction (MI)||Baseline to 28 days after last dose of study drug|The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
2744231|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
2744232|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||ng/mL||Standard Deviation|Mean
2744233|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||Hour||Full Range|Median
2744234|NCT00923156|Secondary|Biomarker Urinary Aldosterone After 12 Weeks of Treatment|24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose.|Baseline,12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.|||ratio||95% Confidence Interval|Geometric Mean
2744235|NCT00923156|Secondary|Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose.|Baseline, 12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.|||ratio||95% Confidence Interval|Geometric Mean
2744236|NCT00923156|Secondary|Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose.|Baseline,12 weeks (84 days, Period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."|||ratio||95% Confidence Interval|Geometric Mean
2744237|NCT00923156|Secondary|Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose.|Baseline, 12 weeks (84 days, period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.|||ratio||95% Confidence Interval|Geometric Mean
2744238|NCT00923156|Primary|Venous Angiotensin II Levels After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose.|Baseline. 12 Weeks (Day 84, period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."|||ratio||95% Confidence Interval|Geometric Mean
2744239|NCT00923130|Other Pre-specified|Regression Rate Constant (d)|This assessment was intended as an exploratory analysis.|up to 50 days|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744240|NCT00923130|Other Pre-specified|Percentage of Participants With an Increase or Decrease in Reverse Contrast Transfer Rate (Kep) Using MRI Versus Conventional Imaging|This assessment was intended as an exploratory analysis.|Cycle 1 before day 1 of treatment and day 5 following infusion|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744241|NCT00923130|Other Pre-specified|Percentage of Participants With an Increase or Decrease in Forward Contrast Transfer Rate (Ktrans) Using MRI Versus Conventional Imaging|This assessment was intended as an exploratory analysis.|Cycle 1 before day 1 of treatment and day 5 following infusion|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744242|NCT00923130|Other Pre-specified|Growth Rate Constant (g)|This assessment was intended as an exploratory analysis.|up to 50 days|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744243|NCT00923130|Other Pre-specified|Tumor Endothelial Markers (TEMs)|This assessment was intended as an exploratory analysis.|Cycle 1 Day 5, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 6 Day 1|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744244|NCT00923130|Other Pre-specified|Micro Vessel Density|This assessment was intended as an exploratory analysis|Prior to cycle 2|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744245|NCT00923130|Other Pre-specified|Circulating Endothelial Cells (CECs)|This assessment was intended as an exploratory analysis.|Baseline, Day 5, and Cycle 2 Day 1|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744246|NCT00923130|Other Pre-specified|Protein Profiling of Vascular Endothelial Growth Factor A (VEGF-A), Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2), Vascular Endothelial Growth Factor Receptor 3 (VEGFR-3), Beta Fibroblast Growth Factor (βFGF) and Erythropoietin From Baseline|This assessment was intended as an exploratory analysis.|Cycle 1 Day 5 (C1D5), Cycle 2 Day 1 (C2D1), Cycle 4 and Cycle 6|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
2744247|NCT00923130|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, assessed up to approximately 7 years.||||months||95% Confidence Interval|Median
2744248|NCT00923130|Secondary|Number of Participants Who Had Biopsies|To obtain tumor tissue and perform analysis for molecular changes in the tumor before and after a cycle of chemotherapy.|Baseline and Cycle 2 Day 1|This outcome measure was not done because biopsy samples were not obtained.||||||
2744249|NCT00923130|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. Adverse events are assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Date treatment consent signed to date off study, approximately 84 months and 25 days||||Participants|||Count of Participants
2744250|NCT00923130|Secondary|Number of Participants With an Objective Response (Complete Response (CR) or Partial Response (PR)) Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response (complete response (CR) and partial response (PR)) was measured by the RECIST. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Two Years||||Participants|||Count of Participants
2744251|NCT00923130|Primary|Progression-free Survival|The time between the first day of treatment to the day of disease progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 44 months||||months||95% Confidence Interval|Median
2744252|NCT00923117|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7/2/08 -12/6/13||||Participants|||Number
2744253|NCT00923117|Primary|6-month Progression-free Survival.|Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|63 patients enrolled with glioblastoma multiforme (GBM) (32 Bev naive, 31 Bev resistant) and were evaluated for this outcome measure.|||Months||95% Confidence Interval|Median
2744254|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.||Week 26 to week 54|The number of subjects up titrated who had blood pressure values at both time points.|||mm Hg||Standard Deviation|Mean
2744255|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 26|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V|||Participants|||Number
2744256|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.|||mm Hg||Standard Error|Least Squares Mean
2744257|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.|||mm Hg||Standard Error|Least Squares Mean
2744258|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV|||Participants|||Number
2744259|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one blood pressure measurement in Period IV|||mm Hg||Standard Error|Least Squares Mean
2744260|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV|||mm Hg||Standard Error|Least Squares Mean
2744261|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 10|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II|||Participants|||Number
2744262|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP).||Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II|||mm Hg||Standard Error|Least Squares Mean
2744263|NCT00923091|Primary|Change in Seated Diastolic Blood Pressure (SeDBP).|Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization|Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II|||mm HG||Standard Error|Least Squares Mean
2744264|NCT00923078|Secondary|Auditory Working Memory (LNS) Change|Auditory working memory is assessed in the MCCB using the Letter-Number Sequencing (LNS) task. LNS is an orally administered test in which and examiner reads strings of numbers and letters, of increasing length over trials, and the respondent mentally reorders the string and reports back to the examiner verbally. Scores represent total number of accurate trials. Analysis is based on age- and gender-corrected t-scores. LNS reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
2744265|NCT00923078|Secondary|Visual Working Memory (Spatial Span) Change|Visual working memory is assessed in the MCCB using the Spatial Span task of the Wechsler Memory Scales-III. Using a board on which 10 cubes are irregularly spaced, the examiner taps patterns of increasing length. The respondent is asked to follow by tapping the pattern in the same or reverse sequence. Scores represent total accuracy combined over forward and reverse span conditions. Analysis is based on age- and gender-corrected t-scores. Spatial Span reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
2744266|NCT00923078|Secondary|Verbal Learning (HVLT-R) Change|The verbal learning domain of the MCCB is assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R). In three Learning Trials, the respondent listens to a 12-item word list read by an examiner and is then asked to recall as many of the words as possible from memory. Scores represent overall accuracy across the three trials, with higher scores indicating better learning. Analysis is based on age- and gender-corrected t-scores. HVLT-R reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
2744267|NCT00923078|Secondary|Visual Learning (BVMT-R) Change|The visual learning domain of the MCCB is assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R). In three Learning Trials, the respondent views a stimulus display for 10 seconds and is then asked to draw as many of the figures as possible in their correct location on a page in the response booklet. Scores represent overall accuracy across the three trials, with higher scores indicating better learning. Analysis is based on age- and gender-corrected t-scores. BVMT-R reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
2744268|NCT00923078|Primary|MCCB Cognitive Composite Score Change|The Cognitive Composite score is derived from the MATRICS Consensus Cognitive Battery (MCCB). The MCCB consists of 10 tests and provides standard scores for each according to seven cognitive domains: (1) speed of processing, (2) attention/vigilance, (3) working memory (verbal and visual), (4) verbal learning, (5) visual learning, (6) reasoning and problem solving, and (7) social cognition. The primary dependent measures derived from the MCCB for purpose of this study is the cognitive composite score, computed as the average of standard (t-scores) scores from each domain excluding social cognition. MCCB Composite reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks|Of N=40 randomized, analysis was based on 38 who completed intervention and post-testing. Across conditions, participants completed, on average, 14.61 hrs of training in Period 1 (12.53 visual, 16.70 auditory) and 14.41 hrs in Period 2 (13.00 visual, 15.92 auditory)|||t-score||Standard Error|Mean
2744269|NCT00923078|Primary|Auditory Mismatch Negativity (MMN) Amplitude Change|Auditory MMN is a fronto-central, mid-latency, potential generated by the auditory cortex in response to deviation in a repetitive stimulus sequence. MMN was assessed using a 3-deviant paradigm in which a series of standard tones (633 Hz, 50ms duration,90%) is interrupted by deviants (10%) that differ either by (1) pitch (1000Hz, 50ms), (2) duration (633 Hz, 100ms), or (3) both (1000Hz, 100ms). MMN was tested concurrently with Visual P300 using a combined task in which subjects were instructed to ignore the auditory stimuli and focus on the visual stimuli. MMN is scored by subtracting each deviant ERP waveform from the standard waveform and measuring the most negative deflection in a window of 50 to 265ms post-stimulus from the resulting difference wave. Primary analysis is based on the combined deviant condition scored at the frontal midline (Fz) electrode site. MMN reported as difference scores from baseline with positive values indicating increased MMN.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||microvolts (uV)||Standard Error|Mean
2744270|NCT00923078|Primary|Visual Target Detection (P300 Event-related Potential Amplitude) Change|"Visual P300 was measured in a 3-stimulus target detection task with target stimuli (10%; large circle) presented in pseudo random order amidst a series of novel (10%; fractal), and standard (80%; small circle) images on a 24 LCD monitor at 100cm viewing distance. Subjects are instructed to press a reaction time button with the preferred hand to Targets only, giving equal importance to speed and accuracy. Primary analysis are based on Target P300b identified as the most positive amplitude deflection within the window of 250-550ms post stimulus at posterior midline electrode Pz. The P300b component is thought to reflect cognitive processes involved in memory updating and decision making. P300 reported as difference scores from baseline with negative values indicating increased P300."|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||microvolts (uV)||Standard Error|Mean
2744271|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Co-morbidities|Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.|Baseline through week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.|||participants|||Number
2744272|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Drug Treatments|Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.|Baseline through Week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.|||participants|||Number
2744300|NCT00922766|Primary|Number of Participants With Major Bleeding Events|Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
2744273|NCT00922987|Secondary|Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET|MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.|Baseline and week 16 or ET|The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2744274|NCT00922987|Secondary|Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit|"The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).~At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse."|Week 16 or ET|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.|||Participants|||Number
2744275|NCT00922987|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.|||participants|||Number
2744276|NCT00922987|Secondary|Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit|VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).|Baseline, week 4 and week 16 or ET|Full Analysis Set (FAS): Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. Analysis was done using LOCF method.|||millimeter (mm)||95% Confidence Interval|Mean
2744277|NCT00922987|Secondary|Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.|Week 4 through week 16 or ET|MFAS: Data collected during the titration phase, i.e. prior to Visit 2 (Week 4) were not analyzed for this endpoint. Only participants who did not discontinue in the first 4 weeks after the baseline visit (titration phase) and had at least 4 weeks of seizure data during the maintenance phase were analyzed for this endpoint.|||Participants|||Number
2744278|NCT00922987|Secondary|Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit|The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.|Baseline and week 16 or ET|MFAS included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. Analysis was done using last observation carried forward (LOCF) method.|||percent change||95% Confidence Interval|Median
2744279|NCT00922987|Primary|Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency|Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.|Baseline through week 16 or early termination (ET)|The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis.|||Percentage of participants||95% Confidence Interval|Number
2744280|NCT00922974|Secondary|The Change Trend in the Functional Assessment of Cancer Therapy - General (FACT-G) Score Over 24 Months||Baseline, 3, 12, and 24 months||2021-04-30|04/2021||||
2744281|NCT00922974|Secondary|The Change Trend in the EuroQol- 5 Dimension (EQ-5D) Score Over 24 Months||Baseline, 3, 12, and 24 months||2021-04-30|04/2021||||
2744282|NCT00922974|Secondary|The Change Trend in the Brief Pain Inventory (BPI) Score Over 24 Months||Baseline, 3, 12, and 24 months||2021-04-30|04/2021||||
2744283|NCT00922974|Secondary|Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at 3 Months (Phase III)|The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change at 3 months is calculated as 3 month score - baseline score with a positive change indicating improvement in QOL.|Baseline and 3 months|Eligible patients who consented to QOL having both baseline and 3 month FACT-G total score.|||score on a scale||Standard Deviation|Mean
2744284|NCT00922974|Secondary|Long-term Effects (24 Months) of Treatment on the Vertebral Bone (e.g., Compression Fracture) and Spinal Cord (Phase III)||Baseline, 3, 12, and 24 months||2021-04-30|04/2021||||
2744285|NCT00922974|Secondary|Percentage of Patients With Adverse Events at 3 Months (Phase III)|Adverse events (AE) were collected using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|Baseline to 3 months|Eligible patients with AE information|||percentage of participants||95% Confidence Interval|Number
2744288|NCT00922974|Primary|Percentage of Patients With Complete or Partial Pain Response at 3 Months (Phase III)|"Pain is measured by the Numerical Rating Pain Scale (NRPS) a numerical 11-point scale (0-10) with 0 = no pain, 1-4 = mild, 5-6 = moderate, and 7-10 = severe with 10 the worst pain imaginable. Pain response is calculated as 3 month score - baseline score with a positive value indicating increased pain and a negative value indicating decreased pain. Patients with complete or partial pain response as defined below are considered responders. The index site is the lesion with the highest baseline (day of radiosurgery) pain score. If multiple sites have the same baseline pain score, the index site is the most cephalad lesion.~Complete response: post-treatment pain score of 0 at the index site, no increase in narcotic pain medication, and no increase in pain score at the secondary treated site(s).~Partial response: post-treatment improvement of at least 3 points at the index site, no increase in narcotic pain medication, and no increase in pain score at the secondary treated site(s)."|Baseline and 3 months|Eligible randomized patients with both baseline and 3 month NRPS scores|||percentage of participants||95% Confidence Interval|Number
2744289|NCT00922974|Primary|Percentage of Patients Receiving Radiosurgery/SBRT Per Protocol or With Minor Variation (Phase II)|"Treatment delivery was centrally reviewed by the study chair and medical physics co-chair. Success was defined as having a review of per protocol or minor variation. A 70% success rate was required for continuation to the phase III component.~Target volume compliance in is defined as the following levels of target coverage in reference to dose volume:~Per protocol: ≥ 90%~Minor variation: 80%-90%~Major deviation: <80% of of dose volume.~Image-Guided Radiotherapy (IGRT) compliance is defined as the following differences in IGRT images between simulation/planning and treatment, as well as at the end of treatment:~Per protocol: <2 mm~Minor variation: 2mm - 3mm~Major deviation: > 3mm"|The day of protocol treatment|Patients enrolled in the phase II component who were eligible and had treatment review information.|||Participants|||Count of Participants
2744290|NCT00922935|Primary|Bone Level Change on Radiographs|Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.|3 years after loading||||mm||Standard Deviation|Mean
2744291|NCT00922883|Primary|The Portion of Drug Responders as Defined by Hematologic Improvements|Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was <9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by an absolute number of at least 4 transfusions for 8 consecutive weeks, compared with the pretreatment transfusion number in the previous 8 weeks); and (3) neutrophil response (when pretreatment absolute neutrophil count [ANC] of <0.5 × 103/μL as at least a 100% increase in ANC, or an ANC increase >0.5 × 103/μL, and the toxicity profile as measured using Common Terminology Criteria for Adverse Events).|12-16 weeks|All subjects who received Eltrombopag were analyzed.|||Participants|||Count of Participants
2744292|NCT00922779|Secondary|Percentage of Participants With Change in Hemoglobin Level|"Change in hemoglobin level (compared to baseline) was reported as significant decrease, Normal (no change), Increase, Decrease, and Missing. Significant decrease was defined as per Investigator's discretion."|Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)|ITT Population.|||Percentage of Participants|||Number
2744293|NCT00922779|Secondary|Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation|HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.|Weeks 12,24 and 48 After Therapy Initiation|ITT Population.|||Percentage of Participants|||Number
2744294|NCT00922779|Secondary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy|SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.|24 weeks after end of therapy (Week 72)|Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.|||Percentage of Participants|||Number
2744295|NCT00922779|Primary|Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.|From signing of informed consent up to end of study (up to Week 72)|Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.|||Participants|||Number
2744296|NCT00922766|Other Pre-specified|Number of Participants With Heparin Induced Thrombocytopenia|Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
2744297|NCT00922766|Other Pre-specified|Number of Participants With Cardiac Arrest- Resuscitated|Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
2744298|NCT00922766|Other Pre-specified|Number of Participants With Stroke|Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
2744302|NCT00922701|Primary|Long Dwell Ultrafiltration|The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.|day 5||||milliliters||Standard Deviation|Mean
2744303|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||Participants|||Number
2744304|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||Participants|||Number
2744305|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744306|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744307|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744308|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744309|NCT00922636|Secondary|Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744411|NCT00922207|Secondary|Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants|||Number
2744310|NCT00922636|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744311|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.||||||
2744312|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.||||||
2744313|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744314|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744315|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744316|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744317|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744362|NCT00922428|Primary|Tenderness|Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744318|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744319|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744320|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744321|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744322|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744323|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744324|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744412|NCT00922207|Secondary|Percentage of Participants Who Were HBeAg Negative||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants||95% Confidence Interval|Number
2744325|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744326|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744327|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744328|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744329|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. LS Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744330|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744363|NCT00922428|Primary|Morning Stiffness|Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744434|NCT00921687|Secondary|Last Clinic BP <130/80 mmHg|Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.|One year||||probability of controlled clinic BP||95% Confidence Interval|Number
2744331|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744332|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group|76-item parent-rated assessment of child's health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of ANCOVA model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744333|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8|76-item parent-rated assessment of child's health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of covariance model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744334|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses adolescent's health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least squares (LS) mean of the change from baseline to endpoint (week 8) is from an ANCOVA model. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline CHIP-AE domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744335|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8|Assesses adolescent's health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least Squares (LS) Mean Change from analysis of covariance model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744336|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744337|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744364|NCT00922428|Primary|Pain on Weight-bearing|Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744338|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744339|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744340|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||Participants|||Number
2744341|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Intent to treat (ITT). All randomized participants with a baseline and at least 1 post-baseline C-SSRS assessment.|||Participants|||Number
2744342|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744343|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744344|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744365|NCT00922428|Primary|Pain After Rest|Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744345|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744346|NCT00922636|Secondary|Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744347|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744348|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||Total Score||Standard Error|Least Squares Mean
2744349|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744350|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744351|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744366|NCT00922428|Primary|Pain in Movement|Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744352|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744353|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
2744354|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744355|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) participant population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744356|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data might have been compromised.|||units on a scale||Standard Error|Least Squares Mean
2744357|NCT00922623|Primary|Percentage of Subjects With Product-related Adverse Events.|Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.|24 weeks|The Full Analysis Set (FAS) consisted of all subjects enrolled and treated with Belotero (ITT principle).|||percentage of subjects with AEs.|||Number
2744358|NCT00922480|Secondary|Diastolic Blood Pressure Change|"Value of DBP at 4 Weeks minus value of DBP at Baseline while in a sitting position~Value of DBP at 8 Weeks minus value of DBP at Baseline while in a sitting position"|baseline and 4 weeks, 8 weeks|As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.|||mmHg||Standard Deviation|Mean
2744359|NCT00922480|Primary|Diastolic Blood Pressure Change|Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position|baseline and 12 weeks|As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.|||mmHg||Standard Deviation|Mean
2744360|NCT00922441|Primary|Mean Change of Diastolic Blood Pressure|24hr Mean change of DBP on Week 8, from Baseline|baseline and 8 Weeks||||mmHg||Standard Deviation|Mean
2744361|NCT00922428|Primary|Antalgic Position|Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744396|NCT00922272|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Open-label Baseline|FAS|||Percent of participants|||Number
2744367|NCT00922428|Primary|Pain at Rest|Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
2744368|NCT00922428|Secondary|Acceptance of the Drug|Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance.|from enrollment until completion|due to the character of an observational study: descriptive|||percentage of participants|||Number
2744369|NCT00922428|Primary|Tolerability of the Drug|"Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3).~It was measured by a score:~very well tolerated (no side effects)~moderately tolerated (mild side effects)~poorly tolerated (marked side effects)"|after end of study|1374 were full analysed, data of 2 patient were additionally analysed for tolerability|||percentage of participants|||Number
2744370|NCT00922428|Primary|Visual Analog Scale (VAS)|Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: all patient who had a value, descriptive|||units on a scale||Standard Deviation|Mean
2744371|NCT00922272|Secondary|Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 4 of Double-blind Phase|Randomized SAS defined as all subjects who took at least 1 dose of randomized investigational product and for whom at least 1 follow-up safety assessment was made.|||Units on a scale||Standard Deviation|Mean
2744372|NCT00922272|Secondary|Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 10 Open-label Phase|Safety Analysis Set (SAS) defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.|||Units on a scale||Standard Deviation|Mean
2744373|NCT00922272|Secondary|Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
2744374|NCT00922272|Secondary|Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
2744375|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
2744376|NCT00922272|Secondary|Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Open-label Baseline and Week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
2744377|NCT00922272|Secondary|Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
2744378|NCT00922272|Secondary|Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
2744379|NCT00922272|Secondary|Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
2744380|NCT00922272|Secondary|Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
2744410|NCT00922207|Secondary|Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels|The normal range for ALT is 10 to 40 international units per liter (IU/L).|Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants|||Number
2744381|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS|||T-scores||Standard Error|Least Squares Mean
2744382|NCT00922272|Secondary|Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS|||T-scores||Standard Deviation|Mean
2744383|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
2744384|NCT00922272|Secondary|Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Open-label Baseline and week 10 Open-label Phase|FAS|||Scores on a scale||Standard Deviation|Mean
2744385|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Double-blind Randomization Baseline and week 4 Double-blind Phase|Randomized FAS|||words recalled||Standard Error|Least Squares Mean
2744386|NCT00922272|Secondary|Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Open-label Baseline and Week 10|FAS|||words recalled||Standard Deviation|Mean
2744387|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Double-blind Randomization Baseline and Week 4|Randomized FAS|||correct sequences||Standard Error|Least Squares Mean
2744388|NCT00922272|Secondary|Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Open-label Baseline and week 10 Open-label Phase|FAS|||correct sequences||Standard Deviation|Mean
2744389|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Double-blind Randomization Baseline and Week 4|Randomized FAS|||correct numerals||Standard Error|Least Squares Mean
2744390|NCT00922272|Secondary|Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Open-label Baseline and week 10 Open-label Phase|FAS|||correct numerals||Standard Deviation|Mean
2744391|NCT00922272|Secondary|Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Double-blind Phase Week 4|Randomized FAS|||Percent of participants|||Number
2744392|NCT00922272|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Open-label Phase Week 10|FAS|||Percent of participants|||Number
2744393|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 4 Double-blind Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 4 Double-blind Phase|Randomized FAS|||Percent of participants|||Number
2744394|NCT00922272|Secondary|Percent of Participants With CGI-S at Double-blind Randomization Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Double-blind Randomization Baseline|Randomized FAS|||Percent of participants|||Number
2744395|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 10 Open-label Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 10 Open-label Phase|FAS|||Percent of participants|||Number
2744397|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS defined as all subjects who received randomized investigational product and had a SANS-18 total scores at week 4 or at the early termination visit.|||Units on a scale||Standard Error|Least Squares Mean
2744398|NCT00922272|Secondary|Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS|||Units on a scale||Standard Deviation|Mean
2744399|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|RES|||Units on a scale||Standard Error|Least Squares Mean
2744400|NCT00922272|Secondary|Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS|||Units on a scale||Standard Deviation|Mean
2744401|NCT00922272|Secondary|Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.~The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 4 Double-blind Phase|RES|||Percent of participants|||Number
2744402|NCT00922272|Primary|Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized Evaluable Set (RES) defined as all randomized subjects who were responders (Response is defined as reduction in total SANS score of greater than or equal to 20%) at the Double-blind Randomization and had SANS-18 total scores at week 4 of the Double-blind Phase or the early termination visit.|||Units on a scale||Standard Error|Least Squares Mean
2744403|NCT00922272|Secondary|Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.~The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 10 Open-label Phase|FAS|||Percent of participants|||Number
2744404|NCT00922272|Primary|Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|Open-label Phase Full Analysis Set (FAS) defined as all enrolled subjects who took at least 1 dose of the investigational product and had 1 primary efficacy assessment after baseline in the Open-label Phase.|||Units on a scale||Standard Deviation|Mean
2744405|NCT00922233|Primary|Participant Report of Adverse Events.|Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken|6.5 months|A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.|||adverse events|||Number
2744406|NCT00922233|Secondary|Acceptability Based on Bleeding Patterns Reported|Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel|6.5 months|A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.|||participants|||Number
2744407|NCT00922233|Primary|Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)|Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived|6.5 months||||pregnancies per 100 woman years|||Number
2744408|NCT00922207|Secondary|Percentage of Participants With Combined Response|Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants|||Number
2744409|NCT00922207|Secondary|Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||International Units/milliliter (IU/mL)||Standard Deviation|Mean
2744413|NCT00922207|Secondary|Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||copies/mL||Standard Deviation|Mean
2744414|NCT00922207|Primary|Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).|Week 100|ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2744415|NCT00922194|Primary|Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More|Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.|Initial and at the end of 12 months or more||||Percentage of HbA1c||95% Confidence Interval|Median
2744416|NCT00922194|Primary|Change in Fasting Blood Glucose From Baseline at 12 Months or More|Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline|Initial and at the end of 12 months or more||||mmol/L||95% Confidence Interval|Median
2744417|NCT00922194|Primary|Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More|Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline|Initial and at the end of 12 months or more||||Ratio||95% Confidence Interval|Median
2744418|NCT00922194|Primary|Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More|Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline|Initial and at the end of 12 months or more||||Ratio||95% Confidence Interval|Median
2744419|NCT00922194|Primary|Change in Waist Circumference From Baseline at 12 Months or More|Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline|Initial and at the end of 12 months or more||||Centimeters||95% Confidence Interval|Median
2744420|NCT00922194|Primary|Change in Body Mass Index (BMI) From Baseline at 12 Months or More|Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline|Initial and at the end of 12 months or more||||kg/m2||95% Confidence Interval|Median
2744421|NCT00922194|Primary|Change in Weight From Baseline at 12 Months or More|Change: Weight after 12 months of therapy or more - weight at baseline|Initial and at the end of 12 months or more||||Kg||95% Confidence Interval|Median
2744422|NCT00922116|Secondary|Average Dose of Mircera Per Month||Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.|||microgram (mcg)||Standard Deviation|Mean
2744423|NCT00922116|Secondary|Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.|||days||Standard Deviation|Mean
2744424|NCT00922116|Secondary|Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population.|||percentage of participants|||Number
2744425|NCT00922116|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP|EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2744426|NCT00922116|Secondary|Change in Hemoglobin Concentration Between SVP and the EEP|Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.|SVP (Baseline), and EEP (Weeks 17 to 24)|ITT population.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2744427|NCT00922116|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)|The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.|||percentage of participants||95% Confidence Interval|Number
2744428|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)|Solicited local and general symptoms experienced within 14 days after vaccination 2|14 days after vaccination||||participants|||Number
2744429|NCT00921947|Secondary|Anti-M2e Serum Antibody Concentration|Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.|42 days (+/- 2)||||Titers||95% Confidence Interval|Geometric Mean
2744430|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)|Solicited local and general symptoms experienced within 7 days after vaccination 1.|0 to 7 days after vaccination|The population analyzed included all participants receiving at least 1 dose of the vaccine.|||participants|||Number
2744431|NCT00921934|Primary|Change of Pain Measured by VAS|VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS|visit 1 - 3|Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).|||pain intensity||Standard Deviation|Mean
2744432|NCT00921895|Primary|Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.|Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.|15 minutes||||percentage of cases||95% Confidence Interval|Number
2744433|NCT00921843|Primary|R-methadone Plasma AUC 0-96hr/Dose||96 hr||||(ng * hr-1 * ml-1 * mg-1||Standard Deviation|Mean
2744435|NCT00921687|Primary|PTH (Parathyroid Hormone) Adherence|Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.|One year||||probability of having a PTH measured|||Number
2744436|NCT00921557|Secondary|Percent of Participants With Detectable Urinary Alendronate|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 48, 96 and 144|||||||
2744437|NCT00921557|Secondary|Change in Centers for Disease Control (CDC) HIV Disease Category|Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up|Weeks 144|Participants who started study treatment.|||Participants|||Count of Participants
2744438|NCT00921557|Secondary|Change in CD4 Percent From Baseline|Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement|Weeks 0, 48, 96 and 144|Participants who started study treatment and had CD4 percent available at week 0.|||percent of lymphocytes that are CD4 cell||95% Confidence Interval|Median
2744439|NCT00921557|Secondary|Percent of Participants With HIV-1 RNA <= 400 Copies/ml|Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|Weeks 0, 48, 96 and 144|Participants who started study treatment.|||Participants|||Count of Participants
2744440|NCT00921557|Secondary|Correlation of Changes in Central Fat Content With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
2744441|NCT00921557|Secondary|Change From Baseline to Week 48 in Central Fat Content|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
2744442|NCT00921557|Secondary|Correlation of Changes in RANKL/OPG Ratio With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
2744443|NCT00921557|Secondary|Change From Baseline to Week 48 in Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
2744444|NCT00921557|Secondary|Correlation of Changes in Bone Marker Turnover With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
2744445|NCT00921557|Secondary|Change From Baseline to Week 48 in Bone Marker Turnover|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
2744446|NCT00921557|Secondary|Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD|Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%.|Weeks 48, 96 and 144|All participants who started study treatment and had measurements available at both time points.|||Percent change||95% Confidence Interval|Median
2744447|NCT00921557|Secondary|Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD|Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%.|Weeks 48, 96 and 144|All participants who started study treatment and had measurements available at the two time points of interest|||Percent change||95% Confidence Interval|Median
2744448|NCT00921557|Secondary|Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.|A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started study treatment and had Whole Body (with head) available at week 0|||percentage of baseline||95% Confidence Interval|Mean
2744449|NCT00921557|Secondary|Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD|A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started study treatment|||percentage of baseline||95% Confidence Interval|Mean
2744450|NCT00921557|Secondary|Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures|Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004).|Weeks 0 to 144|All participants who started treatment|||Participants|||Count of Participants
2744451|NCT00921557|Secondary|Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD|Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.|Weeks 0 and 96|Includes all participants who started study treatment and had measurements available at weeks 0 and 96|||Percent change from baseline||95% Confidence Interval|Median
2744539|NCT00920621|Secondary|Sphingolipid Profile|Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.|3 years|Some measures have missing data due to collection, technical, and processing issues.|||relative abundance (no units)||Standard Deviation|Mean
2744452|NCT00921557|Secondary|Percent Change From Baseline to Week 96 in Lumbar Spine BMD|Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.|Weeks 0 and 96|Includes all participants who started study treatment and had measurements available at weeks 0 and 96|||Percent change from baseline||95% Confidence Interval|Median
2744453|NCT00921557|Secondary|Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD|Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started treatment and had Whole Body (with head) BMD available at week 0|||Percent change from baseline||95% Confidence Interval|Median
2744454|NCT00921557|Primary|Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures|Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.|Week 0 to 48|All participants who started study treatment|||Participants|||Count of Participants
2744455|NCT00921557|Primary|Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD|Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Includes all participants who started study treatment|||Percent change from baseline||95% Confidence Interval|Median
2744456|NCT00921518|Primary|Number of Participants With Acute Kidney Injury|Acuge kidney injury is defined using the AKIN criteria|5 days||||participants|||Number
2744457|NCT00921310|Secondary|Phase 2 Only: Phospho-S6 Levels in Circulating Mononuclear Cells Before and After Treatment||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
2744458|NCT00921310|Secondary|Phase 2 Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
2744459|NCT00921310|Secondary|Phase 2 Only: Survival Rate||1 year after start of treatment||||percentage of participants|||Number
2744460|NCT00921310|Secondary|Phase 2 Only: Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression.|2 years from completion of treatment|There were only (2) patients evaluable for PFS.|||days|||Number
2744461|NCT00921310|Primary|Phase I Only: Phospho-S6 Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
2744462|NCT00921310|Primary|Phase I Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
2744463|NCT00921310|Primary|Phase I and Phase II: Overall Response Rate (Complete Response + Partial Response)|"Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.~Complete response (CR)−disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR)−at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|2 years|(4) patients in Phase 1 were not evaluable for response as they were removed from study prior to week 6 scans. One patient in Phase 2 was not evaluable due to expiring prior to week 6 scans.|||percentage of participants|||Number
2744464|NCT00921310|Primary|Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLT) of Temsirolimus and Pemetrexed|"DLT will be defined as occurring within the first cycle of Phase I only and will be graded according to the Common Terminology Criteria for Adverse Events v 3.0 (CTCAE)~Any grade 3 or higher hematologic toxicity with the exception of anemia.~Any grade 3 or higher non-hematologic toxicity related to study therapy (except alopecia).~Grade 3 or 4 pneumonitis or esophagitis.~Treatment delay of temsirolimus for more than 14 consecutive days due to study-related toxicity.~Treatment delay of pemetrexed therapy for more than 14 consecutive days because of study-related toxicity."|Completion of first cycle (approximately 21 days)||||participants|||Number
2744465|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Temsirolimus That Could be Administered Weekly in Combination With Pemetrexed|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study||||mg|||Number
2744475|NCT00920907|Secondary|Number of Participants Who Developed Antibodies and Neutralizing Antibodies|Electrochemiluminescent (ECL) Immunoassay was used to detect human anti-human ipilimumab antibodies (HAHA) in serum. Blood samples were collected prior to the start of each ipilimumab infusion at Weeks 1, 4, 7, 10, 24, and at end of treatment. Those participants who were positive HAHA on treatment were then tested for presence of neutralizing antibodies.|Prior to start of drug Week 1 to Week 24 on treatment or end of treatment|Participants who received study drug and had HAHA data prior to infusion in Week 1 and while on treatment.|||participants|||Number
2744466|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Pemetrexed That Could be Administered Weekly in Combination With Temsirolimus|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study||||mg/m^2|||Number
2744467|NCT00921115|Primary|Pathologic Complete Response (PCR) Rate|Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).|4 months|Number of participants with PCR after 4 cycles of Neoadjuvant Endocrine Therapy|||participants|||Number
2744468|NCT00921024|Primary|Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|ME: Treated patients, with baseline pathogen, complied with protocol.|||percentage of patients||95% Confidence Interval|Number
2744469|NCT00921024|Primary|Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|mMITT: Treated patients, with baseline pathogen.|||percentage of patients||95% Confidence Interval|Number
2744470|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Electrolyte Laboratory Safety Tests - All Treated Participants|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 - 155; Gr 3: >155 - 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN - 130; Gr 3: <130 - 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN - 5.5; Gr 2: >5.5 - 6.0; Gr 3: > 6.0 - 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN - 3.0; Gr 2: <LLN - 3.0; Gr 3: < 3.0 - 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 - 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN - 11.5, Gr2:>11.5 - 12.5, Gr3: 12.5 - 13.5, Gr4: >13.5. Baseline is screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.|||participants|||Number
2744471|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Chemistry Laboratory Safety Tests (Non-electrolyte) - All Treated Participants|Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP); upper limits of normal (ULN). ALT Gr 1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 g/dL; Gr 2: <3.0 - 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 - 1.5*ULN; Gr 2: >1.5 - 3.0*ULN; Gr 3: >3.0- 6.0*ULN; Gr 4: >6.0*ULN. Lipase (U/L) Gr 1: 1.0 to 1.5*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.0 to 5; Gr 4: >5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Baseline was screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.|||participants|||Number
2744472|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Hematology Laboratory Safety Tests - All Treated Participants|Common Terminology Criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN); grams per deciliter (g/dL); Grade (GR); cells per microliter (c/µL). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute neutrophil (ANC) and ANC plus bands: Gr 1:<LLN to 1.5*10^3 c/µL, Gr 2:<1.5 to 1.0*10^3 c/µL, Gr 3:<1.0 to 0.5*10^3 c/µL, Gr 4:<0.5*10^3 c/µL. Platelet count Gr 1:LLN to 75.0*10^9 c/L, Gr 2:<75.0 to 50.0*10^9 c/L, Gr 3:<50.0 to 25.0*10^9 c/L, Gr 4:<25.0 to 10^9 c/L. Lymphocytes Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL. Baseline is screening or Day 1, prior to dosing.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.|||participants|||Number
2744473|NCT00920907|Secondary|Mean Change From Baseline in Sitting Pulse Rate - All Treated Participants up to Data Cutoff|Pulse Rate was measured in beats per minute (bpm) and was obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.|||bpm||Standard Deviation|Mean
2744474|NCT00920907|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants up to Data Cutoff|Systolic and Diastolic blood pressure were measured in millimeters of mercury (mmHg) and were obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.|||mmHg||Standard Deviation|Mean
2744540|NCT00920621|Secondary|Sphingolipid Profile|Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.|1 year|Some measures have missing data due to collection, technical, and processing issues.|||relative abundance (no units)||Standard Deviation|Mean
2744476|NCT00920907|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Medical Dictionary for Regulatory Activities (MedDRA) version 15.1 was used. Note there is a difference in number of participants with an SAE in this outcome measure and the number listed in the Adverse Events Section of this document. This is because the SAEs reported in the xml upload of the Adverse Events section includes additional participants who reported SAEs after the clinical study report database was closed.|Day 1 to last patient, last visit, approximately 3 years|All participants who received at least 1 dose of ipilimumab.|||participants|||Number
2744477|NCT00920907|Secondary|Model Estimates of Mean Absolute Lymphocyte Count at Each Nominal Ipilimumab Induction Dose and at End of the Induction Dosing Period|Absolute lymphocyte counts (ALC) were obtained throughout the study as part of the hematology panel. Results collected from 28 days prior to the first infusion of ipilimumab through the end of the Induction-Dosing Period were included in the analyses of ALC. Mean ALC was estimated via an extended linear model, with linear splines and a spatial exponential within-patient correlation structure. Lymphocytes were measured as 1000 cells per micro liter (c/µL).|Day 0 (prior to first dose) to Day 84|All participants in the Pharmacodynamic data set with: (1) a baseline ALC evaluation; and (2) at least 1 post-baseline ALC evaluation (after the date of first dose).|||1000 c/µL||95% Confidence Interval|Mean
2744478|NCT00920907|Secondary|Median Overall Survival Following First Ipilimumab Dose - All Treated Participants|Overall survival (OS) was defined as the time between the first dose of study treatment and death and was analyzed using Kaplan-Meier methods, with participants who had not died censored at the last date known to be alive. Overall survival was measured in months.|Week 1 (first dose) to last patient, last visit, approximately 3 years|All participants who received at least one dose of ipilimumab.|||months||95% Confidence Interval|Median
2744479|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Immune-related (ir) Response Criteria (RC) - All Randomized Participants|ir RC=modifications of mWHO criteria reflecting clinical experience with ipilimumab in over 20 completed and/or ongoing clinical studies. irRC were designed to capture clinical activity of ipilimumab immunotherapy that may not be adequately addressed by the mWHO criteria. irComplete Response (irCR): Complete disappearance of all index and non-index lesions. irPartial Response (irPR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index and all new measurable lesions in the absence of irCR, non-index lesions not considered. irStable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (irPD). irProgressive Disease (irPD): At least 25% increase in Tumor Burden when compared to sum of the products of diameters of lesions at nadir.|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions, and for irRC, no resection of new lesions.|||participants|||Number
2744480|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Modified World Health Organization (mWHO) Criteria - All Randomized Participants|Overall Response (OR) was determined as the combination of assessments of index and non-index lesions using mWHO criteria which were: Complete Response=complete disappearance of all lesions; Partial Response=decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease=does not meet criteria for complete or partial response, in the absence of progressive disease, or a decrease or tumor stabilization of one or more non-index lesions; Progressive Disease (Progression)=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s), or progression of non-index lesion(s). OR was measured across the entire study from Day 1 to the last patient, last visit (2009 to 2012)|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions.|||participants|||Number
2744481|NCT00920907|Secondary|Volume of Distribution at Steady State (Vss) of Ipilimumab Manufactured by Process C Relative to the Vss of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|"The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Vss was measured from first dose to end of the induction period (4 doses) in liter(s) (L). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as missing for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1])."|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||L||Geometric Coefficient of Variation|Geometric Mean
2744482|NCT00920907|Primary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Day 21, AUC(0-21d), of Ipilimumab Manufactured by Process C Relative to the AUC(0-21d) of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|"The single-dose pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. AUC(0-21d) was measured from first dose to end of the induction period as micrograms*hours per milliliter (μg*h/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as missing for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1])."|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2744483|NCT00920907|Secondary|Clearance (CLT) of Ipilimumab Manufactured by Process C Relative to the CLT of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|"The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. CLT was measured from first dose to end of the induction period (4 doses) in milliliters per hour (mL/h). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as missing for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1])."|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2744484|NCT00920907|Secondary|Terminal Elimination Half Life (T-HALF) of Ipilimumab Manufactured by Process C Relative to the T-HALF of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|"The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. T-HALF was measured from first dose to end of the induction period (4 doses) in day(s). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as missing for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1])."|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||days||Standard Deviation|Mean
2744485|NCT00920907|Secondary|Time of Maximum Observed Serum Concentration (Tmax) of Ipilimumab Manufactured by Process C Relative to the Tmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|"The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Tmax was measured from first dose to end of the induction period (4 doses) in hours (h). Samples were obtained at 0 h (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as missing for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1])."|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||h||Full Range|Median
2744486|NCT00920907|Primary|Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|"Single-dose Pharmacokinetic (PK) parameters of ipilimumab were derived from serum concentration versus time data. Cmax was measured from first dose to end of the induction period (4 doses) as micrograms per milliliter (μg/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as missing for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1])."|Day 1 to Day 84|Pharmacokinetic (PK) evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2744487|NCT00920855|Secondary|Summary of Participants With Adverse Events (AEs)|Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.|up to 8.5 months. Deaths are reported up to 18 months|Safety population|||participants|||Number
2744488|NCT00920855|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Overall survival is defined as the time from initiation of therapy to death from any cause or last follow-up visit.|up to 23 months|Safety population|||months||95% Confidence Interval|Median
2744489|NCT00920855|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response (DR) is defined as the time from the first response to progressive disease (PD). See outcome #4 for a PD definition.|up to 8.5 months|Participants who had a response|||months||95% Confidence Interval|Median
2744490|NCT00920855|Secondary|Time to the First Response|Time to first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (ie, CR, VGPR, PR, or MR).|up to 8.5 months|Participants who had a response|||months||Standard Deviation|Mean
2744491|NCT00920855|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression free survival is the time between the date of initiation of therapy to progressive disease (PD) or death from any cause, whichever occurs first. See outcome #4 for a definition of PD.|up to 23 months|Safety population|||months||95% Confidence Interval|Median
2744541|NCT00920621|Secondary|Mass Spec Vitamin D Value From Cord Blood at Delivery|Mass Spec Vitamin D value from cord blood at delivery|Blood collection at delivery|Some measures have missing data due to collection, technical, and processing issues.|||ng/mL||Standard Deviation|Mean
2744492|NCT00920855|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP)|"Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following:~>25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L),~>25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h),~>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%),~definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas,~the development of new bone lesions or soft tissue plasmacytomas,~the development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|up to 8.6 months|Safety population|||months||95% Confidence Interval|Median
2744493|NCT00920855|Secondary|Participants' Best Tumor Response as Assessed by the Investigator|Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and <5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for >=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by <100 mg, and disappearance of soft tissue plasmacytomas for >= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a >=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either >=90% or to <200 mg, and >=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a >=25% and <=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.|up to 7.5 months (eight 28-day cycles)|Efficacy population|||participants|||Number
2744494|NCT00920855|Secondary|Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator|Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.|Up to 7.5 months (eight 28-day cycles)|Efficacy population|||percentage of participants||95% Confidence Interval|Number
2744495|NCT00920855|Primary|Participants With Dose Limiting Toxicity (DLT)|"Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:~grade 4 hematologic toxicity without regard for relationship to study drug treatment~thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage~grade 3 febrile neutropenia~grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy~any study drug related grade 3 or grade 4 nonhematologic toxicity~any drug related death~Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3."|Day 1 - 28|Safety population|||participants|||Number
2744496|NCT00920829|Primary|Percent Heavy Drinking Days by mu Opioid Receptor Gene||Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)||||percentage of days||Standard Error|Mean
2744497|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744498|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744499|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744507|NCT00920816|Secondary|Duration of Response (DR): Second-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
2744500|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744501|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants|FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744502|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants|FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744503|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744504|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2744505|NCT00920816|Secondary|Overall Survival (OS): Second-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2744506|NCT00920816|Secondary|Overall Survival (OS): First-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2744538|NCT00920621|Secondary|Child 17q21 Genotype|Genotype at the rs12936231 SNP|3 years|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
2744508|NCT00920816|Secondary|Duration of Response (DR): First-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
2744509|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): Second-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2744510|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): First-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2744511|NCT00920816|Primary|Progression Free Survival (PFS): Second-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2744512|NCT00920816|Primary|Progression Free Survival (PFS): First-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|Full analysis set (FAS) included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2744513|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)||0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.|||hours||Standard Deviation|Mean
2744514|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)|Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.|||ng·h/mL||Standard Deviation|Mean
2744515|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|"Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.~The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose."|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.|||ng/mL||Standard Deviation|Mean
2744516|NCT00920790|Secondary|Overall Survival (OS)|The time from the date of first KW-0761 dosing to the date of death.|Baseline to response|Of the 27 subjects enrolled, 26 were included in the overall survival analysis set, whereas 1 was excluded.|||days||Full Range|Median
2744517|NCT00920790|Secondary|Progression Free Survival (PFS)|"The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.~The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG)."|Baseline to response|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.|||days||Full Range|Median
2744518|NCT00920790|Primary|Overall Response Rate (ORR)|"Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response.~The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR."|From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.|||percentage of participants with response||95% Confidence Interval|Number
2744519|NCT00920699|Secondary|CoQ10 Levels|ng/ml|change from baseline to 20 weeks|data was not available for all participants to compare baseline to 20 weeks|||ng/ml||Standard Deviation|Mean
2744520|NCT00920699|Secondary|8OHdG Levels|ng/ml. Negative value signifies an decrease in 8OHdG levels|change from baseline to 20 weeks|Lab data not available for all participants to compare baseline and 20 weeks|||ng/ml||Standard Deviation|Mean
2744521|NCT00920699|Primary|Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.|No dosage modifications, reported as a %|20 weeks||||percentage of participants|||Number
2744522|NCT00920686|Secondary|24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|24 hours|Number of subjects with headache relief at 24 hours.|||Participants|||Number
2744523|NCT00920686|Secondary|4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|4 hours|Number of subjects with headache relief at 4 hours.|||Participants|||Number
2744524|NCT00920686|Secondary|2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|2 hours|Number of subjects with headache relief at 2 hours.|||Participants|||Number
2744525|NCT00920686|Secondary|Headache Relief and Recurrence (Observed Cases)|"Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.~Headache recurrence is defined as any subject that experiences headache relief within 4 hours, who did not use rescue medication, and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration."|2, 4 and up to 24 hours|Number of subjects who experienced headache relief within 4 hours|||percentage of participants|||Number
2744526|NCT00920686|Primary|Time (Hours) to First Use of Rescue Medication||24 hours|The Full Analysis Set included all those subjects randomized who had dosed with study drug and had at least one (1) post study drug administration observation for headache severity. The Efficacy Evaluable Analysis Set, included all subjects with an imputed (LOCF) HSS at both the 2 hour time point and the 4 hour time point.|||hours||Inter-Quartile Range|Median
2744527|NCT00920647|Secondary|% Change From Baseline in Urinary GAG||Baseline to Week 27||||% Change||Standard Error|Mean
2744528|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Repeated Doses of Intrathecal Idursulfase-IT Given in Conjunction With Elaprase||Weeks 23|Only 1 patient out of 4 in the 1mg dose yielded sufficient data to calculate AUC.|||min*ng/mL||Standard Deviation|Mean
2744529|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Single Administration (Week 3) in Conjunction With Elaprase|Values below lower limit of quantitation (LLOQ) are listed as 0.|Weeks 3|"Data were not available for the calculations in the patients of 1 mg idursulfase-IT group at Week 3.~Serum samples were not obtained from one patient in the 30mg Idursulfase-IT group at Week 3 after IV and IT administration."|||min*ng/mL||Standard Deviation|Mean
2744530|NCT00920647|Primary|Clinically Significant ECG Findings at Any Time During the Study.|Electrocardiogram (ECG) parameters included: heart rate, sinus rhythm, atrial/ventricular hypertrophy, PR, QRS, QT and QTc intervals.|6 months|Abnormalities Any Time Post-baseline ITT Population|||participants|||Number
2744531|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (Serum)||6 months|Development of antibodies post Baseline-ITT Population|||participants|||Number
2744532|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (CSF)|Reflects development of anti-idursulfase antibodies post baseline.|6 months|Abnormalities Any Time Post-baseline ITT Population|||participants|||Number
2744533|NCT00920647|Primary|Safety Changes in Cerebrospinal Fluid (CSF)- White Blood Cells (WBC)|White blood cell count in CSF was monitored throughout the study as a way of assessing any potential inflammation of the meninges induced by idursulfase-IT.|6 months|Abnormalities Any Time Post-baseline ITT Population|||events|||Number
2744534|NCT00920647|Primary|Number of Treatment Emergent Adverse Event (AE)|ITT patient population|Baseline to week 23||||events|||Number
2744535|NCT00920647|Secondary|Level of Idursulfase in the CSF Compartment Resulting From Monthly Idursulfase IT Administrations|Samples collected from patients treated at doses of 1 mg and 30 mg, as well as the control group, were below the lower limit of detection of the bioanalytical method (3.13 ng/mL)|Week 27 (end of study)||||ng/mL||Standard Deviation|Mean
2744536|NCT00920647|Secondary|Change From Baseline in CSF Glycosaminoglycans [GAGs] at Week 27|Percent Change from Baseline to Week 27|Baseline to Week 27||||% change||Standard Error|Mean
2744537|NCT00920647|Primary|Number of Serious Adverse Event (SAE)||6 months|Abnormalities Any Time Post-baseline ITT Population|||events|||Number
2744542|NCT00920621|Secondary|Any Allergic Sensitization in the Child's First 3 Years of Life.|"Any allergic sensitization in the child's first 3 years of life.~*For some variables the negative count incorporates negative and indeterminate."|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
2744543|NCT00920621|Secondary|Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.|Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.|Blood collection at childs' 3 year visit.|Some measures have missing data due to collection, technical, and processing issues.|||ng/mL||Standard Deviation|Mean
2744544|NCT00920621|Secondary|Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.|Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Number of lower respiratory infections|||Number
2744545|NCT00920621|Secondary|Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.|"Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months.~*For some variables the negative count incorporates negative and indeterminate."|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
2744546|NCT00920621|Secondary|Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.|Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.|1 year visit|Some measures have missing data due to collection, technical, and processing issues.|||ng/mL||Standard Deviation|Mean
2744547|NCT00920621|Secondary|Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.|Child positive-specific IgE tests from blood collection at 3 year visit.|3 years|Some measures have missing data due to collection, technical, and processing issues.|||Positive-specific IgE tests|completed tests||Number
2744548|NCT00920621|Primary|Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.|Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy|32-38 weeks gestation|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
2744549|NCT00920621|Primary|Asthma or Recurrent Wheeze in First 3 Years of Life|"Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months.~*For some variables the negative count incorporates negative and indeterminate."|First 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
2744550|NCT00920556|Secondary|Plasma Concentrations of SRT501 at Indicated Time Points|Pharmacokinetic sampling on Day1/2 and Day 20/21 of Cycle 1 for participants ready to participate was planned. The sampling was planned to be collected at timepoints on Cycle 1 Day 1 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose and the same timepoints on Day 2 and Day 20 post- dose. It was to be collected in participants who fasted atleast for an hour. Due to early termination of the study, the data for Pharmacokinetic analysis was not collected.|Cycle 1 Day 1, Cycle 1 Day 2 and Cycle 1 Day 20 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose. Day 2 and Day 20, samples collected post-dose. Each cycle duration was 21 days.|Subjects who receive study drug and have adequate pharmacokinetic data available will be included in the pharmacokinetics population, with data summarized by dose group. Data not collected due to early termination of the study.||||||
2744551|NCT00920556|Primary|Change From Baseline in Biochemistry: Prothrombin Time (PT)/ International Normalized Ratio (INR)|Blood samples were collected to evaluate the biochemistry parameter PT/INR. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety Population. Only those participants available at the particular timepoints were analyzed|||Ratio of PT/INR||Standard Deviation|Mean
2744552|NCT00920556|Primary|Change From Baseline in Biochemistry -Urea, Bicarbonate|Blood samples were collected to evaluate the biochemistry parameter urea and bicarbonate. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety population. Only those participants available at the specified time points were analyzed.|||millimole per liter||Standard Deviation|Mean
2744553|NCT00920556|Primary|Change From in Baseline Biochemistry: Serum Creatinine, Total Bilirubin|Blood samples were collected to evaluate hematology parameters serum creatinine and total bilirubin. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromole per liter||Standard Deviation|Mean
2744554|NCT00920556|Primary|Change From Baseline in Hematology: Red Blood Cell (RBC)|Blood samples were collected to evaluate the hematology parameter RBC. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety population. Only those participants available at the specified time points were analyzed.|||10^12 cells per liter||Standard Deviation|Mean
2744555|NCT00920556|Primary|Change From Baseline in Hematology: Hemoglobin|Blood samples were collected to evaluate the hematology parameter hemoglobin. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety population. Only those participants available at the specified timepoints were analyzed.|||Gram per litre||Standard Deviation|Mean
2744556|NCT00920556|Primary|Change From Baseline in Hematology: Hematocrit|Blood samples were collected to evaluate the hematology parameter hematocrit. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety population. Only those participants available at the specified time-points were analyzed.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2744557|NCT00920556|Primary|Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets|Blood samples collected to evaluate the hematology parameters were WBC count, neutrophils, lymphocytes and platelets. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.|Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)|Safety Population. Only those participants available at the specified timepoints were analyzed.|||10^9 cells per liter (L)||Standard Deviation|Mean
2744558|NCT00920556|Primary|Time to Disease Progression|Time to disease progression was defined as the time from first dose until objective tumor progression. Participants who did not experience tumor progression were censored at their last known date in the study. It was estimated using Kaplan-Meier methodology. Participants who did not experience tumor progression were censored at their last known date in the study. The first quartile for time to disease progression was evaluated when 25th percentile of participants of mITT population reported disease progression. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 75th percentile of participants reported disease progression at the end of the study period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).|From Day 1 till disease progression (approximately 12 cycles of 3 weeks each)|mITT Population. Only those participants available at the specified timepoints were analyzed.|||Months||Inter-Quartile Range|Median
2744559|NCT00920556|Primary|Number of Participants With Progressive Disease (PD) PD as Last Observed Response (LOR)|PD includes one or more of the following criteria: >25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, >25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).|Up to 12 cycles of 3 weeks each|mITT Population.|||Participants|||Count of Participants
2744560|NCT00920556|Primary|Number of Participants With Progressive Disease (PD) PD as Best Response (BR)|PD includes one or more of the following criteria: >25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, >25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).|Up to 12 cycles of 3 weeks each|mITT Population.|||Participants|||Count of Participants
2744561|NCT00920556|Primary|Number of Participants With Stable Disease (SD) as Last Observed Response (LOR)|Stable disease included not meeting the criteria for MR or PD.|Up to 12 cycles of 3 weeks each|mITT Population.|||Participants|||Count of Participants
2744562|NCT00920556|Primary|Number of Participants With Stable Disease (SD) as Best Response (BR)|Stable disease included not meeting the criteria for MR or PD.|Up to 12 cycles of 3 weeks each|mITT Population|||Participants|||Count of Participants
2744563|NCT00920556|Primary|Number of Participants With Partial Response (PR) as Last Observed Response (LOR)|PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).|Up to 12 cycles of 3 weeks each|mITT|||Participants|||Count of Participants
2744564|NCT00920556|Primary|Number of Participants With Minor Response (MR) as Best Response (BR)|MR includes some, but not all, criteria for PR providing the remaining criteria satisfied: ≥25% to ≤ 49% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, a 50 to 89% reduction in 24 hr light chain excretion, which still exceeds 200 mg/24 hr, for at least 2 determinations for a minimum of 6 weeks, 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).|Up to 12 cycles of 3 weeks each|mITT Population.|||Participants|||Count of Participants
2744565|NCT00920556|Primary|Number of Participants With Partial Response (PR) as Best Response (BR)|PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).|Up to 12 cycles of 3 weeks each|mITT Population.|||Participants|||Count of Participants
2744674|NCT00919867|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
2744566|NCT00920556|Primary|Number of Participants With Overall Response Rate|Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); < 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as >= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by >= 90% RE or <200 mg; >= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were >= 25% to <=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.|Approximately up to 12 cycles of 3 weeks|Modified Intent to Treat (mITT), had participants who completed first (2) cycles of SRT501 monotherapy. Participants dropped were not counted; those withdrew after 2nd cycle were considered evaluable regardless of discontinuation reason; alongwith participants discontinued for missing clinical trial material after 2 cycle, were considered.|||Participants|||Count of Participants
2744567|NCT00920556|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Approximately up to 12 cycles of 3 weeks each|Safety Population was defined as all the participants who received any amount of SRT501 or bortezomib.|||Participants|||Count of Participants
2744568|NCT00920439|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
2744569|NCT00920439|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
2744570|NCT00920439|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were temperature [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite= subject did not eat at all. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
2744571|NCT00920439|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
2744572|NCT00920426|Secondary|Day 10 Cmax, C0 and Ctau at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (Cmax, Ctau and C0) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 10|PK Summary Population.|||µg/mL/mg||90% Confidence Interval|Mean
2744573|NCT00920426|Secondary|Day 10 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (AUC[0-tau]) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 10|PK Summary Population.|||hr*µg/mL/mg||90% Confidence Interval|Mean
2744574|NCT00920426|Secondary|Day 1 Cmax and C24 at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (Cmax, and C24) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 1|PK Summary Population.|||μg/mL/mg||90% Confidence Interval|Mean
2744697|NCT00919126|Secondary|Serum Chemistry - Creatinine (Mcmol/L)|Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||mcmol/L||Standard Deviation|Mean
2744575|NCT00920426|Secondary|Day 1 AUC(0-24) at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (AUC[0-24]) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 1|PK Summary Population.|||hr*µg/mL/mg||90% Confidence Interval|Mean
2744576|NCT00920426|Secondary|Accumulation Ratios for AUC, Cmax, and Ctau|The accumulation ratio was calculated as the ratio of AUC(0-τ), Cmax, and Ctau on Day 10 to AUC(0-24), Cmax, and C24 on Day 1 for each participant. The ratio of geometric least square means of each parameter on Day 10 to Day 1 was presented along with 90% confidence interval.|Days 1 and 10|PK/ Pharmacodynamic (PD) Summary Population included participants who met the criteria for both ITT Population and PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Ratio||90% Confidence Interval|Geometric Least Squares Mean
2744577|NCT00920426|Secondary|Pre-morning Dose Concentrations (C0) on Day 2 Through 10 to Assess the Achievement of Steady State of GSK1265744 Following Repeat Administration|Steady state is said to be reached, when the pre-dose concentration slope estimate is close to zero. The data for pre-dose concentration on Day 1 24 hours (Day 2) through Day 10 has been presented.|Day 1 24 hours (Day 2), Pre-dose on Days 3, 4, 7, 8, 9 and 10|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||µg/mL||Standard Deviation|Mean
2744578|NCT00920426|Secondary|Change From Baseline in CD4+ Cell Count to Day 11|Whole venous blood samples was obtained from each participant for the analysis of lymphocyte subsets by flow cytometry on Day 1 and Day 11. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Cells per cubic millimeter||Standard Deviation|Mean
2744579|NCT00920426|Secondary|Number of Participants With HIV-1 RNA<50 Copies/mL|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.|Up to Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
2744580|NCT00920426|Secondary|Number of Participants With HIV-1 RNA<400 Copies/mL|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.|Up to Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
2744581|NCT00920426|Secondary|Plasma HIV-1 RNA Rate of Decline (Slope) Over 11 Days|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Estimated mean rate of decline (i.e., slope of day) with corresponding 90% confidence interval was provided for each treatment.|Up to Day 10|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||log10 copies per mL per day||90% Confidence Interval|Mean
2744582|NCT00920426|Secondary|Change From Baseline in Plasma HIV-1 RNA to Nadir Over 11 Days|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Nadir was the maximum change from Baseline in plasma HIV-1 RNA. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||log10 copies/mL||Standard Deviation|Mean
2744583|NCT00920426|Secondary|Change From Baseline in Plasma HIV-1 RNA|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA were collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1 pre-dose) and Day 1 (post dose), 2, 3, 4, 7, 8, 9, 10|ITT population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Log10 copies/mL||Standard Deviation|Mean
2744584|NCT00920426|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters|All ECGs were obtained after a minimum 10 minute rest in a semi-supine position. The 12-lead ECGs were obtained at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10 using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and Bazett's correction (QTcB) and Fridericia correction (QTcF) intervals. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Milliseconds (msec)||Standard Deviation|Mean
2744585|NCT00920426|Primary|Change From Baseline in Vital Sign: Heart Rate|Heart rate was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Beats per minute||Standard Deviation|Mean
2744586|NCT00920426|Primary|Change From Baseline in Vital Sign: Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2744587|NCT00920426|Primary|Number of Participants With Urinalysis Data|Samples for urinalysis assessment was collected on Day 1, Day 3 and Day 10. Urinalysis parameters included urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine pH, urine protein, urine specific gravity and urine leukocyte esterase test for detecting white blood cell.|Day 1 to Day 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
2744588|NCT00920426|Primary|Change From Baseline in Clinical Chemistry Data: Chloride, Carbon Dioxide Content/Bicarbonate, Magnesium, Sodium, Potassium|Blood samples for assessment of clinical chemistry parameters of chloride, carbon dioxide content/bicarbonate, magnesium, sodium and potassium was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Milliequivalents per liter||Standard Deviation|Mean
2744589|NCT00920426|Primary|Change From Baseline in Direct Bilirubin, Total Bilirubin, Calcium, Cholesterol, Creatinine, Glucose, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, Triglycerides, Urea/Blood Urea Nitrogen|Blood samples for assessment of clinical chemistry parameters of direct bilirubin, total bilirubin, calcium, cholesterol, creatinine, glucose, HDL cholesterol direct, LDL cholesterol calculation, triglycerides,Urea/BUN was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Milligrams per deciliter||Standard Deviation|Mean
2744590|NCT00920426|Primary|Change From Baseline in Clinical Chemistry Data: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Lipase|Blood samples for assessment of clinical chemistry parameters of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and lipase was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Units per liter||Standard Deviation|Mean
2744591|NCT00920426|Primary|Change From Baseline in Clinical Chemistry Data: Albumin, Total Protein|Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Grams per deciliter||Standard Deviation|Mean
2744592|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Reticulocytes|Blood samples for assessment of hematology parameter of reticulocytes was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Giga cells per liter||Standard Deviation|Mean
2744593|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Red Blood Cell Count|Blood samples for assessment of hematology parameter of red blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Million cells per microliter||Standard Deviation|Mean
2744594|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Platelet Count|Blood samples for assessment of hematology parameter of platelet count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Cells per cubic millimeter||Standard Deviation|Mean
2744595|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Mean Corpuscle Volume|Blood samples for assessment of hematology parameter of mean corpuscle volume was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Femtoliter||Standard Deviation|Mean
2744596|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Mean Corpuscle Hemoglobin|Blood samples for assessment of hematology parameter of mean corpuscle hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Picogram||Standard Deviation|Mean
2744597|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Hemoglobin|Blood samples for assessment of hematology parameter of hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Grams per deciliter||Standard Deviation|Mean
2744598|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC- Absolute Neutrophil Count), White Blood Cell Count|Blood samples for assessment of hematology parameters of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC- absolute neutrophil count) and white blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Thousand cells per microliter||Standard Deviation|Mean
2744599|NCT00920426|Primary|Number of Participants With Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or is associated with liver injury and impaired liver function.|Day 1 to Day 11|Safety population was defined as all participants who were randomized into the study with documented evidence of having received at least 1 dose of randomized treatment. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
2744600|NCT00920426|Primary|GSK1265744 PK Parameters Following Last Repeat Administration on Day 10: Apparent Clearance Following Oral Dosing (CL/F)|Blood samples for PK analysis of CL/F of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2744601|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Terminal Half-life (t1/2) and Absorption Lag Time (Tlag)|PK sampling was planned to be collected up to 24 hours only on Day 1 and Day 10. The data for this outcome measure was however not collected.|Day 1 and Day 10|PK Summary Population. Data for this outcome measure was not collected. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.||||||
2744602|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Time to Cmax (Tmax)|Blood samples for PK analysis of tmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Hour||Full Range|Median
2744603|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Maximum Observed Concentration (Cmax)|Blood samples for PK analysis of Cmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2744604|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 10: Predose Concentration (C0), Concentration at End of Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin)|Blood samples for PK analysis of C0, Ctau and Cmin of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2744698|NCT00919126|Secondary|Serum Chemistry - Gamma GT (IU/L)|Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients)|||IU/L||Standard Deviation|Mean
2744605|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 10: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau])|Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||hr*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2744606|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1: Concentration at 24 Hours Post Dose (C24)|Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2744607|NCT00920426|Primary|GSK1265744 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments(AUC[0-24])|Blood samples for PK analysis of AUC(0-24) of GSK1265744 was collected on Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK Summary Population included participants with evaluable PK profile of GSK1265744 on Day 10. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Hour*microgram per milliliter (hr*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2744608|NCT00920426|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) to Day 11|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a lower limit of detection (LLOD) of 50 copies/milliliter (mL) (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 11|Intent-to-treat (ITT) population comprised of all participants who met study criteria and randomized into study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post-baseline HIV-1 RNA measurement. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||log10 copies/mL||Standard Deviation|Mean
2744609|NCT00920374|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period||||Participants|||Count of Participants
2744610|NCT00920374|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||Participants|||Count of Participants
2744611|NCT00920374|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever|During the 4-day (Day 0-3) post-vaccination period||||Participants|||Count of Participants
2744612|NCT00920374|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period||||Participants|||Count of Participants
2744613|NCT00920374|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2744614|NCT00920374|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||fold change||95% Confidence Interval|Mean
2744615|NCT00920374|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2744616|NCT00920374|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2744617|NCT00920374|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||Participants|||Count of Participants
2744618|NCT00920374|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data|||titer||95% Confidence Interval|Geometric Mean
2744619|NCT00920309|Secondary|Glomerular Filtration Rate (Kidney Function)||2 years|Outcome measures were not analyzed due to study termination||||||
2744620|NCT00920309|Primary|Total Kidney Volume (mL)||2 years|Outcome Measures were not analyzed due to study termination||||||
2744621|NCT00920231|Secondary|Ability to Meet the Subjective Travel Needs of the Blind Subject|This is a subjective rating that incorporates user friendliness of the system and the specific needs of the subject. The subject is asked to rate whether the device meets his or her travel needs on a 1 to 7 scale with 1 being excellent and 7 being very poor.|no time limit||||units on a scale||Standard Error|Mean
2744622|NCT00920231|Primary|Frequency of Device Failures Per Attempt to Complete a Navigation Course|device failures were defined as any failure to provide correct location and direction information at thre appropriate time, resulting in a mistake that needed the initial prototype's ability to meet their travel needs at a good to excellent range.|The subject is given as much time as needed to complete the task||||number of device failures per attempt||Standard Error|Mean
2744623|NCT00920218|Secondary|Number of Subjects With Confirmed Herpes Zoster (HZ) Cases|A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study.|During the entire study period (from Day 0 to Month 15)|he analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744624|NCT00920218|Secondary|Anti-gE Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||Standard Deviation|Mean
2744625|NCT00920218|Secondary|Anti-gE Geometric Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
2744626|NCT00920218|Secondary|VZV-specific Mean Antibody Concentrations|Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3, 4 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||Standard Deviation|Mean
2744627|NCT00920218|Secondary|Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3, 4 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
2744628|NCT00920218|Secondary|Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines|The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).|At Months 0, 1, 2, 3 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
2744629|NCT00920218|Secondary|Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens|The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).|At Months 0, 1, 2, 3, 4 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||VZV specific CD4+ T-cells/million Tcells||Standard Deviation|Mean
2744630|NCT00920218|Primary|Anti-gE Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||Standard Deviation|Mean
2744631|NCT00920218|Primary|Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
2744675|NCT00919867|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-amphetamine. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
2744632|NCT00920218|Primary|Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines|The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
2744633|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744634|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 3|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744635|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 2|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744636|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 1|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744637|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 0|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744638|NCT00920218|Primary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders|Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|During the entire study period (from Day 0 to Month 15)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744639|NCT00920218|Primary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders|Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|Within the 30-day (Days 0-29) post last vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744640|NCT00920218|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 15)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744641|NCT00920218|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Any time during the study up to Day 29 after the last vaccination|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744642|NCT00920218|Primary|Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.|During the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2744643|NCT00920218|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [including nausea, vomiting, diarrhoea and abdominal pain], temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-days (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2744644|NCT00920218|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-days (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2744645|NCT00920140|Secondary|Overall Survival by Cohort|Overall survival is defined as the time from the start of study treatment (GSK1120212) until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.|From the start of the study drug until the final study visit (up to approximately 407 days )|Efficacy Population. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).|||Months||90% Confidence Interval|Median
2744646|NCT00920140|Secondary|Ctau of GSK1120212 in Part 2|Ctau is the pre-dose (trough) concentration at the end of the dosing interval and was measured for Cycle 1 Day 15 (C1D15), Cycle 2 Day 1(C2D1), Cylce 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), Cycle 7 Day 1 (C7D1), Cycle 8 Day 1 (C8D1), Cycle 9 Day 1 (C9D1), Cycle 10 Day 1 (C10D1), Cycle 11 Day 1 (C11D1) and Cycle 12 Day 1 (C12D1). Blood samples for PK analysis were collected pre-dose (i.e., no later than 15 min prior to dosing).|C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1 and C12D1|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2744647|NCT00920140|Secondary|Accumulation Ratio (AR) of GSK1120212 in Part 1|AR is the ratio of the Day 15 AUC0-tau (0 hour to last dose interval) and Day 1 AUC0-tau (AUCtau C1D15/AUCtau C1D1). Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2744648|NCT00920140|Secondary|Tmax of GSK1120212 in Part 1|Tmax is defined as the time to reach the observed maximum concentration and was measured for C1D1 and C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||Hours||Full Range|Median
2744649|NCT00920140|Secondary|t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half and was measured for C1D1. t1/2eff. is defined as the effective half-life and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2744650|NCT00920140|Secondary|Cmin and Cmax of GSK1120212 in Part 1|Cmax is defined as the maximum observed concentration of GSK1120212 and was measured for C1D1 and C1D15. Cmin is defined as the minimal observed concentration of GSK1120212 and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2744676|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Percentage of lymphocytes||Standard Error|Mean
2744794|NCT00918463|Secondary|To Evaluate the Safety of Dasatinib Monotherapy as Treatment for Subjects With Relapsed or Refractory Aggressive DLBCL.||2 years|Data was not collected due to early termination of the study.||||||
2744651|NCT00920140|Secondary|AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 24 hours (AUC[0-24]) for Cycle 1 Day 1 (C1D1), from time zero to the last time of a quantifiable concentration (AUC[0-t]) for C1D1 and Cylce 1 Day 15 (C1D15) and AUC curve over the dosing interval AUC[0-tau] for C1D15 were measured. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 minutes [min] before study drug administration) and at 0.5 hour (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed.|||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2744652|NCT00920140|Primary|Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort|Overall response rate (ORR=CR+CRp+Marrow CR+MLFS+PR) was calculated from the investigator's assessment of response recorded within the first eight weeks of treatment. CR includes complete remission. Complete remission is a state in which the participant must be free of all symptoms related to leukemia and have an absolute neutrophil count >=1 x 10^9/L, platelet count >=100 x 10^9/L, and normal marrow differential (<=5% blasts). PR includes partial remission. Partial remission is a state in which the participant has a CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. CRp is as per CR but platelet count <100 x 10^9/L. MLFS is a state in which the participant has a normal marrow differential (<5% blasts), neutrophil, and platelet counts are not considered.|From the start of the study drug until the final study visit (up to approximately 407 days)|Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).|||Participants|||Number
2744653|NCT00920140|Primary|Number of Participants With a Change From Baseline in Temperature by Dose|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants (par.) are counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
2744654|NCT00920140|Primary|Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3/4 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3/4 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values are assumed to have a Baseline value of grade 0. Only those participants (par.) with blood pressure values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
2744655|NCT00920140|Primary|Number of Participants With a Change From Baseline in Heart Rate by Dose|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants are counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-baseline. Only those participants (par.) with heart rate values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
2744656|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose|Hematology and clinical chemistry data were summarized according to NCI-CTCAE grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, bicarbonate, potassium, magnesium, sodium, and phosphorus. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
2744677|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||log10 copies/mL||Standard Error|Mean
2744657|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, international normalized ratio (INR), lymphocytes, total neutrophils, platelet count, and partial thromboplastin time (PTT). Participants with missing baseline grades were assumed to have a baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy (defined as the worst shift that occurred at any time during the treatment period) are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
2744658|NCT00920140|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose|An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
2744659|NCT00920075|Secondary|Number of Participants With Fracture|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.|Post study (1-6 years), one clinical visit|11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained.|||participants|||Number
2744660|NCT00920075|Secondary|Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.|Post study (1-6 years), one clincial visit|11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density.|||participants|||Number
2744661|NCT00920075|Primary|Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.|Post study (1-6 yrs), one clinical visit|Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures.|||participants|||Number
2744662|NCT00920023|Primary|To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.|Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.|3 years||||Percentage of true negative sample||95% Confidence Interval|Number
2744663|NCT00920023|Primary|To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.|Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.|3 years||||percentage of positive cases||95% Confidence Interval|Number
2744664|NCT00919932|Secondary|Exit Interview|Verbal interview|1 month||||participants|||Number
2744665|NCT00919932|Primary|Therapy Homework Compliance: Percent Homework Completed|Number of thought logs completed over the course of the 4 week trial.|1 month||||homework sheets completed||Standard Deviation|Mean
2744666|NCT00919893|Primary|Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)|Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.|0, 6, 12 weeks|ITT (Intention to treat) LOCF (Last observation carried forward)|||participants|||Number
2744667|NCT00919893|Secondary|Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.|Decrease of score points. Decrease of leucocytes in urine.|0, 6, 12 weeks||||participants|||Number
2744668|NCT00919867|Primary|T 1/2 of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2744669|NCT00919867|Primary|Tmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2744670|NCT00919867|Primary|AUC of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
2744671|NCT00919867|Primary|Cmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng/ml||Standard Deviation|Mean
2744672|NCT00919867|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2744673|NCT00919867|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2744678|NCT00919854|Secondary|Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
2744679|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
2744680|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48||Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
2744681|NCT00919854|Primary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR)|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 24|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
2744682|NCT00919802|Secondary|Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration|A verbal anxiety report (VAR; 0-10 with 0 being no anxiety and 10 being the worst possible anxiety); a change from baseline measure was calculated for value measured 6 hours post drug/placebo administration|6 hours post drug or placebo administration||||units on a scale||Standard Error|Mean
2744683|NCT00919802|Primary|Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours|This is a seven-point symmetric scale previously validated for use in IC studies in which patients are asked relative to baseline (over the last 6 hours for purposes of this study), -3 -are you markedly worse, -2 -moderately worse, -1 -slightly worse, 0-no change, +1-slightly improved, +2-moderately improved, or +3-markedly improved. A +2 or +3 can be defined categorically as a positive treatment response|6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data||||units on a scale||Standard Error|Mean
2744684|NCT00919763|Secondary|Percent Change in TSS||from Baseline to Week 4|||||||
2744685|NCT00919763|Primary|Total Sum Score (TSS)of Target Lesion|"Total Sum Score (TSS) on the Target Lesion at Week 4 or Early Termination adjusted on Baseline (Sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification of Target Lesion).~Scale values range from 0 - 3; 0 is minumal (best) and 3 is maximum (worst). Unit is used as score on a scale. Total possible minimum score is 0. Total possible maximum score is 15."|at Week 4|intention to treat (ITT) Last Observation Carried Forward (LOCF)|||Scores on a scale||Standard Error|Least Squares Mean
2744686|NCT00919724|Primary|Endothelial Function (Brachial Artery Reactivity)|The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.|Single measurement||||percent dilation||Standard Deviation|Mean
2744687|NCT00919711|Secondary|Lumbar Spine BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation|||Percent Change From Baseline||95% Confidence Interval|Mean
2744688|NCT00919711|Secondary|Femoral Neck BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation|||Percent Change From Baseline||95% Confidence Interval|Mean
2744689|NCT00919711|Secondary|Serum CTX Percent Change From Baseline at Month 1|Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1|Baseline to month 1|All randomized subjects who enrolled in the bone marker substudy with observed data|||Percent Change From Baseline||Inter-Quartile Range|Median
2744690|NCT00919711|Primary|Total Hip BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation|||Percent Change From Baseline||95% Confidence Interval|Mean
2744691|NCT00919633|Secondary|Early Virologic Response (EVR)||Study week 12||||participants|||Number
2744692|NCT00919633|Secondary|Rapid Virologic Response (RVR)||Study Week 4||||participants|||Number
2744693|NCT00919633|Primary|Viral Load: Incidence of Sustained Virologic Response (SVR)||24 weeks after treatment is complete||||participants|||Number
2744694|NCT00919191|Secondary|Self Assessment of Burning/Stinging and Itching|Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe|Daily, for 3 weeks||||Scores on a Scale||Standard Deviation|Mean
2744695|NCT00919191|Primary|Comparative Assessment of Facial Irritation and Cutaneous Effects.|Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe|Daily, for 3 weeks|All participants used both gels concurrently, on opposite sides of the face (split-face model)|||Scores on a Scale||Standard Deviation|Mean
2744696|NCT00919126|Secondary|Serum Chemistry - Urea (mmol/L)|Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||mmol/L||Standard Deviation|Mean
2744699|NCT00919126|Secondary|Serum Chemistry - ALT (GPT) (IU/L)|ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||IU/L||Standard Deviation|Mean
2744700|NCT00919126|Secondary|Serum Chemistry - AST (GOT) (IU/L)|AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||IU/L||Standard Deviation|Mean
2744701|NCT00919126|Secondary|Haematology - Platelets (Giga/L)|Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||Giga/L||Standard Deviation|Mean
2744702|NCT00919126|Secondary|Haematology - Erythrocytes (Tera/L)|Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day.|The analysis was done in the ITT Data Set (Randomised Patients).|||Tera/L||Standard Deviation|Mean
2744703|NCT00919126|Secondary|Haematology - Leucocytes (Giga/L)|Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||Giga/L||Standard Deviation|Mean
2744704|NCT00919126|Secondary|Stay in the Recovery Room|Time interval between admission in the recovery room and discharge from the recovery room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
2744705|NCT00919126|Secondary|Stay in the Operating Room|Time interval between admission in the operating room and discharge from the operating room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
2744706|NCT00919126|Secondary|Awakening Time|Time interval between the end of maintenance period and time of Aldrete score ≥ 9.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
2744707|NCT00919126|Secondary|Anaesthesia Recovery Time|Time interval between the end of maintenance period and time of tracheal tube removal.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
2744708|NCT00919126|Primary|Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)|Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.|Maintenance period (1 Day)|The main analysis was done in the ITT Data Set (Randomised Patients).|||mg adjusted||Standard Deviation|Mean
2744709|NCT00919113|Secondary|Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.|Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF|at week 11|Efficacy analysis performed according to randomized treatment.|||participants|||Number
2744710|NCT00919113|Primary|Global Response Assessment (GRA) Responders at Week 11.|"subjects that indicated markedly improved or moderately improved on the GRA, LOCF"|at week 11|Efficacy analysis performed according to randomized treatment.|||participants|||Number
2744711|NCT00919100|Secondary|Number of Participants With Venipuncture Success in One Attempt||5 minutes||||Participants|||Count of Participants
2744712|NCT00919100|Secondary|OSBD-R Observational Pain/Distress Scale|The Observational Scale of Behavioral Distress (OSBD) is a validated and commonly used scale. There are 11 OSBD distress responses (information seeking, cry, scream, physical restraint, verbal resistance, seeking emotional support, verbal pain, flail, verbal fear, muscular rigidity, and nervous behavior). Using videotapes of the venipuncture, a composite OSBD score of 1 (low distress) to 11 (high distress) was assigned from the time of placement of tourniquet to placement of the bandage or securing the intravenous line (IV) after the first attempt. Two students not associated with the hospital or the device had been previously trained in this methodology and coded all tapes. A supervisor assessed interrater reliability on each coded behavior. After each group of 10 subjects, interrater agreements that fell below the level of excellent agreement (kappa = 0.80) were reviewed and discussed by both coders, with the consensus score recorded and definitions of observed behaviors.|5 minute||||units on a scale||Full Range|Median
2744713|NCT00919100|Primary|Faces Pain Scale-Revised (FPS-R)|Self-report measure of pain via 6 faces ranging from neutral to increasing pain expression. The scoring for the scale ranges from 0-10 with lower scores representing lower pain and higher scores representing higher pain. The FPS-R was conducted several minutes following venipuncture. This time was not tracked, but it was typically between 2-5 minutes following completion of the venipuncture.|5 minute||||units on a scale||Full Range|Median
2744714|NCT00919061|Primary|Median PFS|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 mos||||months||95% Confidence Interval|Median
2744715|NCT00919061|Primary|Progression-Free Survival|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 months||||percentage of participants||95% Confidence Interval|Number
2744716|NCT00919035|Secondary|Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment|PSA Doubling time is defined as the length of time that it takes for an individual patients PSA to double. PSA doubling times were calculated using the medial records at study entry for each patient. While the patient was on study their PSA doubling times were also calculated.|evaluate PSA doubling time pre study to actual doubling time while on study - calculated from start of study up to 10 cycles or 40 weeks.|PSA doubling time pre study was compared to PSA doubling time while the patients are on study, per protocol.|||percentage of participants|||Number
2744795|NCT00918463|Primary|Response Rate|Response rate will be used as a measure of efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL)|2 years|Data was not collected due to early termination of the study.||||||
2744895|NCT00917124|Secondary|Evidence of Coma, Stupor, Cerebral Insult, Delirium, Ventilation Longer Than 24 Hours, Myocardial Infarction, Atrial Fibrillation, Dialysis, Reoperation for Bleeding, Infection, Hospital Stay > 7 Days||7 postoperative days||||participants|||Number
2744717|NCT00919035|Secondary|Time to Disease Progression|Time to disease progression is defined as the length of time from when the patient starts the study till disease progression. Disease progression is defined as more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Or the appearance of 2 or more new bony lesions on a bone scan. Or newly developed cord compression or pathologic fracture.|Disease progression is assessed every 2 months, for up to 40 weeks, measured from day one of protocol treatment until the date the patient is off study.||||months||Full Range|Mean
2744718|NCT00919035|Primary|Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).|The overall clinical benefit is defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). CR: is the disappearance of all measurable lesions including bone lesions detected on the bone scan, no evidence of new lesions, and no disease-related symptoms. PR: More than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. SD: Lesions should have no sufficient decrease for PR or CR and no sufficient increase to meet criteria for Progressive Disease (PD). PD: > 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies OR The appearance of 2 or more new bony lesions on a bone scan is satisfactory for PD. Newly developed cord compression or pathologic fracture is defined as PD.|disease progression is assessed every 2 cycles, for up to 40weeks, per protocol, from the date of the first dose of study drug to the date the patient is taken off study||||percentage of participants|||Number
2744719|NCT00918957|Primary|Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier|Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.|||change in percentage||Standard Error|Least Squares Mean
2744720|NCT00918957|Primary|Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)|"Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.~In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error.~﻿Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.|||change in percentage||Standard Error|Least Squares Mean
2744721|NCT00918957|Secondary|Tobramycin Serum Concentration|"Descriptive statistics of serum and sputum concentrations per scheduled sampling time.~Detectable concentration values at pre-dose on Day 1 were excluded from the analysis."|Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose|"Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.~This measures the concentration of active substance in the body at different time-point to evaluate there is abnormal accumulation of active substance. Not for Placebo Patients."|||μ﻿g/mL||Standard Deviation|Mean
2744722|NCT00918957|Secondary|Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug|"Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.~Day 1 is the scheduled visit of first study drug administration."|Day 1, Day 29|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received.|||Percentage of participants|||Number
2744723|NCT00918957|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|"Serious Adverse Events (on and off treatment) by preferred term and treatment group.~Preferred terms are sorted in descending order of frequency in the TIP treatment group.~A patient with multiple occurrences of the same preferred term is counted only once in the preferred term."|Time of consent, 4 weeks after study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.|||percentage of participants|||Number
2744724|NCT00918957|Secondary|Percentage of Participants With Adverse Events (AEs)|"Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.~Primary system organ classes are sorted in descending order of frequency in the TIP treatment group.~A patient with more than one AE within a primary system organ class is counted only once for that class."|First administration of study drug, study completion|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received|||Percentage of participants|||Number
2744725|NCT00918957|Secondary|Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal|"Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.~Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline."|Baseline, Study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.|||percentage of participants at risk|||Number
2744800|NCT00918346|Primary|Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Intention To Treat (ITT): randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.|||mmHg||95% Confidence Interval|Mean
2744726|NCT00918957|Secondary|Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)|Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||μg/mL||Standard Deviation|Mean
2744727|NCT00918957|Secondary|Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)|"P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).~If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed."|Baseline, Day 29, Day 57|﻿Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Log10 CFU (colony forming unit)||Standard Error|Mean
2744728|NCT00918957|Secondary|Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)|"﻿FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity~For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value."|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||percentage change||Standard Error|Least Squares Mean
2744729|NCT00918957|Secondary|Change From Baseline of ﻿Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)|"Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.~Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error"|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||percentage change||Standard Error|Mean
2744730|NCT00918957|Primary|Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)|"Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.~ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.~BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication~- Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.|||change in percentage||Standard Error|Least Squares Mean
2744731|NCT00918931|Primary|Response Rate|Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus criteria).|3-Month Response Evaluation|Analysis was per protocol.|||participants|||Number
2744732|NCT00918879|Secondary|Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24|Proportion of participants (expressed in percentage of total participants)achieving HbA1c < 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||Percentage of Participants|||Number
2744733|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mmol/L||Standard Error|Mean
2744734|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2744801|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 4|IOPs at week 4: mean IOP values at four timepoints (worse eye)|Week 4|IOPs of all subjects who received preserved/unpreserved formulation|||mmHg||Standard Deviation|Mean
2744735|NCT00918879|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||percent||Standard Error|Mean
2744736|NCT00918866|Secondary|Immunology Panel- Tryptase|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||ug/ml||Standard Deviation|Mean
2744737|NCT00918866|Secondary|Immunology Panel- Interleuken-6|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||pg/ml||Standard Deviation|Mean
2744738|NCT00918866|Secondary|Immunology Panel- Complement 5A(C5A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||ng/ml||Standard Deviation|Mean
2744739|NCT00918866|Secondary|Immunology Panel- Complement 3A (C3A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||ng/ml||Standard Deviation|Mean
2744740|NCT00918866|Primary|Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose|Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose|31-35 minutes minus baseline|Per the protocol|||mm Hg||Standard Deviation|Mean
2744741|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744742|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744743|NCT00918749|Secondary|Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|ITT Population|2 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744744|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744745|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744746|NCT00918749|Secondary|Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.|2 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744747|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population||3 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744748|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population||2 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744749|NCT00918749|Primary|Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population|Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.|Month 4|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
2744750|NCT00918736|Secondary|Rescue Acetaminophen Consumption|The use of all analgesic medication during the study period was recorded on a diary card by the patient.|6 months||2009-10-31|10/2009||||
2744751|NCT00918736|Secondary|Systemic and Local Adverse Events Recording|he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card|6 months||2009-10-31|10/2009||||
2744752|NCT00918736|Secondary|the Level of Global Satisfaction Based on a 7-point Categorical Scale|The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.|6 months||2009-10-31|10/2009||||
2744753|NCT00918736|Secondary|Four Clinical Balance Tests|"Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed  Up-and-Go test (TUG) ,Berg Balance Scale (BBS)"|6 months||2009-09-30|09/2009||||
2744754|NCT00918736|Secondary|Ankle Sagittal Range of Motion|Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.|6 months||2009-09-30|09/2009||||
2744755|NCT00918736|Secondary|The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score|The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment|6 months||2009-10-31|10/2009||||
2744756|NCT00918736|Primary|Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months|The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable|baseline and 6 months|The statistical analysis was done on completers.|||score on a scale||Standard Deviation|Mean
2744796|NCT00918385|Secondary|Overall Response Rate of Men With Low AR Activity|Tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During dasatinib monotherapy ( at least 12 weeks)|Of the 17 subjects treated, 15 had response documentation and are included in the calculation. Two were omitted (1 because response documentation was not provided; 1 ended treatment after 2 weeks for toxicity prior to repeat scans).|||percentage of patients with CR,PR||95% Confidence Interval|Number
2744757|NCT00918723|Secondary|To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat|Responses were measured after completion of FCR+ vorinostat induction therapy (within 21 days of starting maintenance) and again after completion of maintenance therapy (24 months after the start of maintenance therapy). Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat. Criteria for response are specified by the National Cancer Institute (NCI) working group guidelines; in addition, patients were required to meet computed tomography (CT) criteria as described in the protocol. Response categories include Complete Response (CR), Partial Response (PR), Nodular Partial Response (nPR), Stable Disease (SD) or Progressive Disease (PD).|After completion of maintenance therapy (24 months after start of maintenance)|Participants who had a partial response (PR) or nodular partial response (nPR) after FCR+vorinostat induction therapy, as measured within 21 days of starting maintenance therapy. Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat.|||percentage of participants|||Number
2744758|NCT00918723|Secondary|To Eliminate Residual Disease (Documented by Flow Cytometry and/or Polymerase Chain Reaction [PCR]) in Patients Who Have Achieved Complete Response (CR) After Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Vorinostat||Within 21 days prior to starting maintenance therapy|Patients who achieved a complete response (CR) after induction therapy and had minimal residual disease (MRD) status tested using flow cytometry|||Participants|||Count of Participants
2744759|NCT00918723|Primary|Overall Survival|Overall survival (OS): The percentage of people in a study who are still alive at for a certain period of time after they started treatment.|2 years||||percentage of participants||95% Confidence Interval|Number
2744760|NCT00918723|Primary|Percentage of Patients With Progression-free Survival at 2 Years|"Progression-free survival (PFS): The length of time during and after the treatment that a patient lives with the disease but it does not get worse.~Progressive disease is specified by the NCI (National Cancer Institute) working group guidelines and additional CT (computerized tomography) scan requirements:~Lymphadenopathy, > 50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations; one lymph node must be at least 2 cm.~An increase in the liver or spleen size by 50% or more by CT scan or the de novo appearance of hepatomegaly or splenomegaly.~An increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter.~Transformation to a more aggressive histology or occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL."|2 years||||percentage of participants||95% Confidence Interval|Number
2744761|NCT00918723|Primary|Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)|"The MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg."|28 days||||mg|||Number
2744762|NCT00918684|Primary|Stroop Color-Word Test|A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.|14 weeks (12th week of treatment)||||units on a scale||Standard Deviation|Mean
2744763|NCT00918684|Primary|WHODAS-II Disability Scale|A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.|14 weeks (12th week of treatment)||||units on a scale||Standard Deviation|Mean
2744764|NCT00918684|Primary|Hamilton Depression Rating Scale.|A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|14 weeks (12th week of treatment)||||units on a scale||Standard Deviation|Mean
2744765|NCT00918671|Secondary|Change of Medication Days/Month Compared to Baseline||Baseline and after 4 years' of follow-up||||medication days/month||Standard Deviation|Mean
2744766|NCT00918671|Primary|Change in Headache Days/Month After 4 Years Compared to Baseline|Change in headache days/month after 4 years compared to baseline|Baseline and after 4 years||||headache days/month||Standard Deviation|Mean
2744767|NCT00918645|Secondary|Number of Patients With Correlation Between 41Ca Clearance and Disease Stage|Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.|Samples will be collected over 18 months|Due to small population size Data were not collected||||||
2744768|NCT00918645|Secondary|Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression|Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.|Samples will be collected over 18 months|Due to small population size of both Urinary samples and disease progression, no correlation data was collected||||||
2744769|NCT00918645|Primary|Number of Patients Whose Samples Were Measured for Pharmacokinetics|Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted).|Samples will be collected over 18 months|No data was collected from the specimens.||||||
2744797|NCT00918385|Secondary|Overall Response Rate of Men With High AR Activity|Tumor response was based on Response Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During monotherapy (at least 12 weeks)|14 subjects began treatment; 13 with response documentation are included in the calculation; 1 subject was omitted because response documentation was not provided.|||percentage of patients with CR,PR||95% Confidence Interval|Number
2744798|NCT00918385|Primary|Progression Free Survival (PFS)|PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.|During monotherapy ( at least 12 weeks)||||months||90% Confidence Interval|Median
2744770|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2|"Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified systemic event. Participants may be represented in more than 1 category."|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.|||percentage of participants|||Number
2744771|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1|"Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified systemic event. Participants may be represented in more than 1 category."|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.|||percentage of participants|||Number
2744772|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2|"Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified local reaction. Participants may be represented in more than 1 category."|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.|||percentage of participants|||Number
2744773|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1|"Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here Number of participants analyzed signifies the safety population for Dose 1 and N signifies those participants who reported Yes for at least 1 day or No for all days for specified local reaction. Participants may be represented in more than 1 category."|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.|||percentage of participants|||Number
2744774|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||titer||95% Confidence Interval|Geometric Mean
2744775|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||titer||95% Confidence Interval|Geometric Mean
2744802|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 1|IOPs at week 1: mean IOP values at four timepoints (worse eye)|Week 1|IOPs of all subjects who received preserved/unpreserved formulation|||mmHg||Standard Deviation|Mean
2744776|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||mcg/mL||95% Confidence Interval|Geometric Mean
2744777|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2744778|NCT00918580|Secondary|Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||ratio of GMFR||95% Confidence Interval|Geometric Mean
2744779|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||fold rise||95% Confidence Interval|Geometric Mean
2744780|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||fold rise||95% Confidence Interval|Geometric Mean
2744799|NCT00918346|Primary|Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Per Protocol (PP): randomized patients who completed the study per protocol (i.e. excluded from PP is the discontinued patient and a patient with major protocol violation)|||mmHg||95% Confidence Interval|Mean
2744824|NCT00918229|Secondary|Rate of Occurrence of Grade 2 or Greater Rectal Adverse Event or Procedure Related Adverse Events.|Compare the rate of occurrence of rectal adverse events and implantation procedure related adverse events in balloon and control groups.|6 months||||Participants|||Count of Participants
2744781|NCT00918580|Primary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||fold rise||95% Confidence Interval|Geometric Mean
2744782|NCT00918567|Secondary|ADHD Subscale of the DBD (Teacher Completed) at Endpoint|"The ADHD subscale of the DBD consists of 18 items that are the DSM-IV symptoms of ADHD. Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies."|Endpoint (Week 8)|ITT used|||units on a scale||Standard Error|Mean
2744783|NCT00918567|Secondary|ADHD Subscale of the DBD (Parent Completed) at Endpoint|"The DBD consists of 18 items that are the DSM-IV symptoms of ADHD. Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies."|Endpoint (Week 8)|Intent to treat|||units on a scale||Standard Deviation|Mean
2744784|NCT00918567|Secondary|Social Skills Rating Scale Problem Behavior Subscale(SSRS Teachers) at Endpoint|"The SSRS was completed by teachers to measure children's problem behaviors (PB). Items are rated from 0 (not at all) to 2 (very often). The scale has 55 items. The score reported below is the sum total of the items on the scale and then averaged for the whole group. Therefore, the range can be between 0 and 110. A higher score indicates a better outcome."|Endpoint (Week 8)|ITT was used|||units on a scale||Standard Error|Mean
2744785|NCT00918567|Secondary|Social Skills Rating Scale Problem Behavior Subscale(SSRS Parent) at Endpoint|"completed by parents to measure children's problem behaviors (PB). Items are rated from 0 (not at all) to 2 (very often). The scale has 55 items. The score reported below is the sum total of the items on the scale and then averaged for the whole group. Therefore, the range can be between 0 and 110. A higher score indicates a better outcome."|Endpoint (Week 8)|ITT was used|||units on a scale||Standard Error|Mean
2744786|NCT00918567|Secondary|Disruptive Behavior Disorder Rating Scale ODD Subscale(DBD- Teacher Completed) at Endpoint|"The DBD consists of 8 items that are the DSM-IV symptoms of Oppositional Defiant Disorder (ODD). Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies."|Endpoint (Week 8)|ITT was used|||units on a scale||Standard Error|Mean
2744787|NCT00918567|Secondary|Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint|"The DBD consists of 8 items that are the DSM-IV symptoms of Oppositional Defiant Disorder (ODD). Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 (not at all) to 3 (very much). The factor structure, reliability and validity of the DBD have been supported in multiple studies."|Endpoint (Week 8)|ITT was used|||units on a scale||Standard Error|Mean
2744788|NCT00918567|Secondary|Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated):|"The PSERS measures adverse events commonly associated with stimulant medication and has been used in multiple studies of ADHD. For this study, the PSERS was modified to also assess adverse emotional events potentially associated with ATX, including suicidal statements. The resulting scale consisted of 13 items (for teachers) rated from 0 (none) to 3 (severe). An overall side effects score was computed by averaging across all ratings and used in analyses."|at weeks 8 (Endpoint)|ITT was used|||units on a scale||Standard Error|Mean
2744789|NCT00918567|Secondary|Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint:|"The PSERS measures adverse events commonly associated with stimulant medication and has been used in multiple studies of ADHD. For this study, the PSERS was modified to also assess adverse emotional events potentially associated with ATX, including suicidal statements. The resulting scale consisted of 14 items (an additional sleep item for parents) rated from 0 (none) to 3 (severe). An overall side effects score was computed by averaging across all ratings and used in analyses."|Endpoint (Week 8)|ITT was used|||units on a scale||Standard Error|Mean
2744790|NCT00918567|Secondary|Impairment Rating Scale (Teachers) at Endpoint|The IRS is a 6 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance, and classroom behavior. The scale is scored from 0 (no problem) to 6 (extreme problem). The scale has excellent test-retest and inter-rater reliability and well supported validity.|Endpoint (Week 8)|ITT was used|||units on a scale||Standard Error|Mean
2744791|NCT00918567|Secondary|Impairment Rating Scale (Parent Completed) at Endpoint|The IRS is a 8 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance, and classroom behavior 51. The scale is scored from 0 (no problem) to 6 (extreme problem). The scale has excellent test-retest and inter-rater reliability and well supported validity 51, 52.|Endpoint (Week 8)|Intent to treat|||units on a scale||Standard Error|Mean
2744792|NCT00918567|Primary|Rule Violations During Direct Classroom Observation at Endpoint (Week 8)|Observations were conducted using the Student Behavior Teacher Response Observation Code. After learning the classroom rules, observers watched children in their classrooms for 30 minutes during an academic activity and recorded each time the subject violated a classroom rule. Total classroom rule violations were used as the primary outcome measures for the study.|Endpoint (Week 8)|all subjects analyzed using ITT|||number occurences per 30 mins||Standard Error|Mean
2744793|NCT00918463|Secondary|To Determine Potential Correlatives of Response.||2 years|Data was not collected due to early termination of the study.||||||
2744803|NCT00918346|Secondary|Change From Baseline in Time-wise IOPs at Week 4|The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 4|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.|||mmHg||95% Confidence Interval|Mean
2744804|NCT00918346|Secondary|Overall and Time-wise Comparisons of IOP at Week 1|The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 1|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.|||mmHg||95% Confidence Interval|Mean
2744805|NCT00918346|Primary|Intraocular Pressures (IOPs) at Baseline|IOPs at baseline: mean IOP values at four timepoints (worse eye)|Baseline|IOPs of all subjects who received preserved/unpreserved formulation|||mmHg||Standard Deviation|Mean
2744806|NCT00918333|Other Pre-specified|Changes in Biological Markers|Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.|Baseline to up to 12 courses|||||||
2744807|NCT00918333|Other Pre-specified|Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters|Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.|Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose|||||||
2744808|NCT00918333|Secondary|Duration of Response (Phase II)|Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, < 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) or minor response(MR, defined as ≥25% but < 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.|The time from the date at which the patient's objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment|Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2744809|NCT00918333|Secondary|Progression-free Survival (Phase II)|Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment|Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.|||months||95% Confidence Interval|Median
2744810|NCT00918333|Secondary|Overall Survival Time (Phase II)|Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 2 years post-treatment|Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.|||months||95% Confidence Interval|Median
2744811|NCT00918333|Primary|Overall Response Rate (Phase II)|For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, < 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h), or minor response(MR, defined as ≥25% but < 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|Up to 12 courses|Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.|||percentage of patients||95% Confidence Interval|Number
2744924|NCT00916383|Primary|Skin Irritation (Edema)|Edema was used to determine skin irritation using a modified Draize scale. Score 0 = no edema; Score 1 = very slight edema; Score 2 = slight edema; Score 3 = moderate to severe edema; Score 4 = severe edema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||units on a scale||Standard Deviation|Mean
2744812|NCT00918333|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.|4 weeks|The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).|||Participants|||Count of Participants
2744813|NCT00918281|Secondary|The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.|Safety was monitored throughout the duration of the subject's participation.|Up to 8 weeks post contrast administration.|The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE).|||number of adverse events|||Number
2744814|NCT00918281|Primary|Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.|Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.|Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.|Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).|||Standardized Uptake Value||Standard Deviation|Mean
2744815|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 52|||||||
2744816|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 52|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 52|||||||
2744817|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 16|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 16|Population was Intent-to-treat (ITT). Imputation method was Last Observation Carried Forward (LOCF).|||scores on a scale||Inter-Quartile Range|Median
2744818|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 12|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 12|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
2744819|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 8|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
2744820|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 4|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 4|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
2744821|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 2|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 2|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
2744822|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 16|Population was Intent-to-treat (ITT) and included participants with any inflammatory nodules (defined as tender, erythematous) or plaques at Baseline. Imputation method was Last Observation Carried Forward (LOCF).|||percent change||Standard Error|Least Squares Mean
2744823|NCT00918255|Primary|Percentage of Participants Achieving Clinical Response at Week 16|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 16|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
2746416|NCT00906178|Primary|Sex Without a Condom as Assessed by Self-report|Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months|6-months post-intervention|ITT - Intention to Treat|||participants|||Number
2744825|NCT00918229|Primary|Proportion of Subjects Achieving a Reduction of at Least 25% of the Volume of the Rectum Receiving at Least 70 Gy.|Evaluated in subjects with prostate cancer who underwent radiotherapy by means of IMRT and who received the ProSpace, with individual patient success defined as a reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values.|6 months||||Participants|||Count of Participants
2744826|NCT00918203|Secondary|PK - Steady State Volume of Distribution (Vss) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2744827|NCT00918203|Secondary|PK - Clearance (Cl) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.|||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2744828|NCT00918203|Secondary|PK - Half-Life (t1/2) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||days||Full Range|Geometric Mean
2744829|NCT00918203|Secondary|PK - Maximum Concentration (Cmax) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2744830|NCT00918203|Secondary|Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab|AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.|Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2744831|NCT00918203|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline to Study Completion (Up to 8 Months)|All randomized participants who had baseline and post baseline Anti-Olaratumab antibodies. Those participants who did not meet eligibility criteria were not included in this assessment.|||percentage of participants|||Number
2744832|NCT00918203|Secondary|Pharmacodynamics of Olaratumab|Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).|Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab|No data was available due to the collection of plasma samples was not fit for the assessment of PDGFs, as the collection procedure did not prevent platelet activation resulting in elevated levels of PDGFs in the circulation. Pharmacodynamics data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||||||
2744833|NCT00918203|Secondary|Median Duration of Response|The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.|First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug and had achieved tumor response of CR or PR. Median Duration of Response data was not analyzed in the crossover olaratumab arm.|||weeks||95% Confidence Interval|Median
2744834|NCT00918203|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Baseline to Measured PD or Study Discontinuation (Up to 31 Months)|All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.|||percentage of participants||95% Confidence Interval|Number
2744835|NCT00918203|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.|Baseline to Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. OS data was not analyzed in the crossover olaratumab arm. Participants censored: olaratumab + paclitaxel + carboplatin = 19 and paclitaxel + carboplatin = 20.|||weeks||95% Confidence Interval|Median
2744836|NCT00918203|Secondary|Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events||Up to 43 Months|All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.|||participants|||Number
2745438|NCT00913380|Other Pre-specified|Estimate of Carcinogenic Risk Induced by CT Radiation|Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used.|1 day after CT|||||||
2744837|NCT00918203|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (Up to 43 Months)|All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.|||participants|||Number
2744838|NCT00918203|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression by RECIST version 1.1, or death from any cause. Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Baseline to Measured PD or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. Participants censored: paclitaxel + carboplatin = 13, olaratumab + paclitaxel + carboplatin = 20, and crossover to olaratumab = 4. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.|||weeks||95% Confidence Interval|Median
2744839|NCT00918138|Other Pre-specified|Participants With Reported Hypoglycemic Adverse Events During Treatment Period|Hypoglycemic events are based upon the Saxagliptin Predefined List of Events, which includes hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. The Hypoglycemic events occurred in less than 5% of the participants and hence do not appear in the adverse events module.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.||||participants|||Number
2744840|NCT00918138|Other Pre-specified|Participants With Confirmed Hypoglycemia Events During the Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick for glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|Treated participants|||participants|||Number
2744841|NCT00918138|Secondary|Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal|FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments. Last Observation Carried Forward (LOCF).|||mg/dL||Standard Error|Mean
2744842|NCT00918138|Secondary|Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)|Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.|||mg/dL||Standard Error|Mean
2744843|NCT00918138|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.|||mg/dL||Standard Error|Mean
2744844|NCT00918125|Other Pre-specified|Mean Knowledge Scores About ICD Therapy One Week Post Intervention.|We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.|one week post intervention|Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data.|||units on a scale||Standard Deviation|Mean
2744845|NCT00918125|Secondary|Receipt of an ICD|Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.|3 months|All patients with data at 3 months|||participants|||Number
2744846|NCT00918125|Secondary|Decisional Conflict Scale|At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).|one week post intervention|Patients with data at one week|||units on a scale||Standard Deviation|Mean
2744847|NCT00918125|Primary|Decision to Receive an ICD|At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.|1 week post intervention|All patients with available data at one week|||Participants|||Number
2744848|NCT00917865|Secondary|Mean SUVmax of Low Versus High Gleason Groups|To determine id radiotracer uptake correlates with gleason score|4 minutes,16 minutes,28 minutes and 40 minutes||||Mean SUV max||Standard Deviation|Mean
2744863|NCT00917579|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||ng•hr/mL||Standard Deviation|Mean
2744849|NCT00917865|Primary|Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis|"Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor.~Sensitivity: Proportion of people with a disease who have a positive test result~Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted.~Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted~Accuracy: Ability of the test to differentiate between disease and non-disease.~Note: 'n=' is the denominator used to compute each parameter."|At 4, 16, 28 and 40 minutes post-injection of FACBC|The number of participants for analysis was based on the protocol.Each prostate was divided into 12 sextants and then each sextant was visualized for abnormal focal uptake.The SUVmax for the malignant sextants were compared to that of the benign sextants. Note: 'n=' is the denominator used to compute each parameter.|||Percentage of Sextants|Participants|95% Confidence Interval|Number
2744850|NCT00917852|Primary|Major Device Events|Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.|1 month post-treatment||||Participants|||Count of Participants
2744851|NCT00917852|Primary|All Cause Mortality||30 days post-treatment|All enrolled subjects|||participants|||Number
2744852|NCT00917735|Primary|Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3|Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.|Baseline and month 12|Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12|||ng/ml||95% Confidence Interval|Geometric Mean
2744853|NCT00917735|Primary|Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)|Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.|Baseline and month 12|Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12|||pg/ml||95% Confidence Interval|Geometric Mean
2744854|NCT00917735|Primary|Mammographic Density|Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.|Baseline and month 12|Mammographic density at baseline and month 12|||Percent||95% Confidence Interval|Geometric Mean
2744855|NCT00917644|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||hours||Standard Deviation|Mean
2744856|NCT00917644|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||ng/mL||Standard Deviation|Mean
2744857|NCT00917644|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast). PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||ng*hr/mL||Standard Deviation|Mean
2744858|NCT00917644|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||hours||Full Range|Median
2744859|NCT00917644|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng*hr/mL). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population defined as all subjects randomized and treated who had > = 1 of the parameters of primary interest in > = 1 treatment period.|||ng*hr/mL||Standard Deviation|Mean
2744860|NCT00917579|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||hours||Standard Deviation|Mean
2744861|NCT00917579|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||hours||Inter-Quartile Range|Median
2744862|NCT00917579|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||ng/mL||Standard Deviation|Mean
2744864|NCT00917579|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|Pharmacokinetic (PK) parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, except 1 time point.|||ng•hr/mL||Standard Deviation|Mean
2744865|NCT00917553|Secondary|Number of Participants Who Developed Vitreous or Preretinal Hemorrhage|Any participants who developed vitreous or preretinal hemorrhage were counted. Had there been any preretinal hemorrhages (a subcategory of vitreous hemorrhage) these would have been shown as a separate row.|24 months||||Participants|||Count of Participants
2744866|NCT00917553|Secondary|Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level|Participants are shown categorically by whether they reached PDR, or whether their diabetic retinopathy levels changed by one grade or more, as analyzed by fundus photography.|Baseline to 24 months||||Participants|||Count of Participants
2744867|NCT00917553|Secondary|Change in Macular Volume||Baseline and 24 months||||mm^3||Standard Deviation|Mean
2744868|NCT00917553|Secondary|Change Thickness Thickness|Anatomic outcomes were assessed through optical coherence. Positive numbers indicate increases in thickness.|Baseline and 24 months||||µm||Standard Deviation|Mean
2744869|NCT00917553|Primary|The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group||Baseline and 24 months|Two participants in the placebo group and one in the doxycycline group were unavailable for 24 month results.|||dB||Standard Deviation|Mean
2744870|NCT00917501|Primary|Change From Baseline in Depression Symptom Severity at 12 Weeks|Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)|Baseline and 12 weeks||||Total score on CDRS-R||Standard Deviation|Mean
2744871|NCT00917462|Secondary|Percentage of Tumors With High Phosphorylated Extracellular Signal-regulated Kinase Expression||anytime prior to enrollment or during protocol therapy||||% of tumors with high pERK expression|||Number
2744872|NCT00917462|Secondary|Exploratory Analysis of Differential Response Between Squamous Cell Carcinoma and Adenocarcinoma.||2 years|Data were not collected||||||
2744873|NCT00917462|Secondary|Number of Participants With Adverse Events||every week while on study||||Participants|||Count of Participants
2744874|NCT00917462|Secondary|Overall Response Rate (Partial Response and Complete Response) of Sorafenib.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|after the first four weeks of therapy, at eight weeks, and every eight weeks thereafter, an average of 1 year||||Participants|||Count of Participants
2744875|NCT00917462|Primary|2-month Progression-free Survival (PFS) of Sorafenib in Patients With Metastatic or Recurrent Esophageal and Gastroesophageal (GE) Junction Cancer.||2 months||||Participants|||Count of Participants
2744876|NCT00917384|Secondary|Number of Participants Who Developed Antibodies Against IMC-1121B|The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.|Baseline, 12 Weeks|Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.|||participants|||Number
2744877|NCT00917384|Secondary|Maximum Concentration (Cmax) of IMC-1121B|Cmax was not analyzed as only pre-dose samples were collected.|6 weeks post-randomization|Zero participants were analyzed.||||||
2744878|NCT00917384|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.|Randomization up to 18 months|Safety Population: All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2744879|NCT00917384|Secondary|Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.|Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])|All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2744880|NCT00917384|Secondary|Duration of Response (DOR)|DOR is the interval from date of initial documented response (complete response [CR] or partial response [PR]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.|Randomization up to 17 months post-randomization|Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.||||||
2746436|NCT00906074|Primary|Type of Surgeon|Surgical speciality of physician who performed surgery.|Day 0 (day of surgery)|No data collected|||surgeon|||Number
2744881|NCT00917384|Secondary|Percentage of Participants With Objective Response (Objective Response Rate [ORR])|ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.|Randomization up to 17 months post-randomization|Intent-to-treat population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2744882|NCT00917384|Secondary|Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)|The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.|Week 12 post-randomization|Intent-to-treat population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2744883|NCT00917384|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).|Randomization up to 17 months|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.|||months||95% Confidence Interval|Median
2744884|NCT00917384|Primary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive|Randomization up to 28 months post-randomization|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.|||months||95% Confidence Interval|Median
2744885|NCT00917267|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.|||events per subject-year||Standard Error|Mean
2744886|NCT00917267|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was not imputed.|||mmHg||Standard Deviation|Mean
2744887|NCT00917267|Secondary|Ratio of Triglycerides (TG) at Week 26 to Baseline|Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||ratio||Standard Error|Least Squares Mean
2744888|NCT00917267|Secondary|Change in High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in HDL from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
2744889|NCT00917267|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 26|Change in TC from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
2744890|NCT00917267|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Least Squares Mean
2744891|NCT00917267|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
2744892|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.|||percentage of patients|||Number
2744893|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||percentage of patients|||Number
2744894|NCT00917267|Primary|Change in HbA1c From Baseline to Week 26.|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2744896|NCT00917124|Primary|Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.|"The Mini-Mental State Examination (MMSE) total score is calculated by summing the item scores across several aspects of cognition. The maximum possible total score is 30 points.~Color Trials Test (CTT) measures sustained visual attention, visual scanning and graphomotor skills. The examiner records the length of time (in seconds) required by the patient to rapidly draw a line connecting the circles numbered 1 through 25 in consecutive order.~Grooved-Pegboard test (GP test) is manipulative dexterity test that contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted. The examiner records the time in seconds.~Cognitive impairment was defined as a decline in postoperative performance in one or more tests: decrease of MMSE score three points or more from baseline and decrease of one standard deviation or more in performance on CTT 1 and GP tests"|preoperative, 7 days postoperative|"3 participants in Control group did not perform control cognitive test- transferred to another hospital.~6 participants in INVOS group did not perform control cognitive test - transferred to another hospital n=4, declined to participate n=2"|||participants|||Number
2744897|NCT00916929|Secondary|Sensitivity|Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).|6-months|All patients enrolled in the study were included in this analysis with a total of 82 patients in each group. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D during data collection period. These 2 patients were censored from ICD cohort and included in CRT-D cohort at the time of upgrade based on as-treated analysis principle.|||percentage of true positives||95% Confidence Interval|Number
2744898|NCT00916929|Primary|False Positive Rate|False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.|6-months|All patients participating in the study were included in the analysis with a total of 82 patients in each arm. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D. These 2 patients were censored from the ICD cohort and included in the CRT-D cohort at the time of upgrade based on as-treated analysis principle resulting.|||departures from device threshold||95% Confidence Interval|Number
2744899|NCT00916721|Primary|Change in the Corrugator Muscle (EMG) Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Corrugator EMG will be obtained through Ag/AgCl electrodes. The amplified EMG signal will be integrated using a 300-msec. time constant. A Coulbourn Modular Instrument System was used to measure corrugator EMG during 4 periods; baseline, reading, imagery and recovery|Corrugator EMG level was measured at visit 3, after presentation of two neutral and two smoking scripts||||µV||Standard Deviation|Mean
2744900|NCT00916721|Primary|Change in Heart Rate (Beats Per Minute), Caused by Smoking Cues, Measured Using Script Driven Imagery|Heart rate was measured through 9-mm (sensor diameter) Ag/AgCl electrodes filled with electrolytic paste and placed on the medial surface of each forearm. Amplified electrocardiogram signal will input to a tachometer that will provide a voltage output reflecting interbeat interval, which will be transformed to HR. A Coulbourn Modular Instrument System was used to measure HR during 4 periods; baseline, reading, imagery and recovery|Heart rate was measured at visit 3, after presentation of two neutral and two smoking scripts||||beats per minute||Standard Deviation|Mean
2744901|NCT00916721|Primary|Change in the Skin Conductance Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Skin conductance level was obtained through 9-mm (sensor diameter) Ag/AgCl electrodes filled with isotonic paste placed on the non-dominant hypothenar surface using a constant-voltage technique. A Coulbourn Modular Instrument System was used to measure SC during 4 periods; baseline, reading, imagery and recovery.|skin conductance was measured at visit 3, after presentation of two neutral and two smoking scripts||||µS||Standard Deviation|Mean
2744902|NCT00916721|Secondary|Change in Craving Level to Smoking Cues Caused by Smoking Cues, Measured Using Script Driven Imagery|"Craving level will be measured using a 8 point Visual Analogue Scale (VAS) of craving. Participants will be ask How much do you want a cigarette right now Participants will answer accordingly: 0=no desire at all; 7=unable to resist craving"|Craving level was measured at visit 3, after presentation of two neutral and two smoking scripts||||units on a scale||Standard Deviation|Mean
2744903|NCT00916643|Primary|Frequency and Severity of CHD Symptoms (Angina)|This is equatable to the incidence of Cardiovascular AEs.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.|||participants|||Number
2744904|NCT00916643|Primary|Serious Unexpected Adverse Events||Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.|||participants|||Number
2744905|NCT00916643|Primary|Occurrence of Cardiovascular Events and Interventions|Adverse Events reported for Cardiovascular disease not directly related to therapy.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.|||participants|||Number
2744906|NCT00916643|Primary|Occurence of Death|The Categories listed in the table are the Adverse Events (or similar) that resulted in death.|Participants were followed for one (1) year following discontinuation of treatment.|Inclusion was per protocol.|||participants|||Number
2744907|NCT00916617|Secondary|Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination||36 months|Because this study was terminated early, the planned pharmacokinetic analyses were not performed.||||||
2744925|NCT00916383|Primary|Skin Irritation (Erythema)|Erythema was used to determine skin irritation using a modified Draize scale. Score 0 = no erythema; Score 1 = very slight erythema; Score 2 = well-defined erythema; Score 3 = moderate to severe erythema; Score 4 = severe erythema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||units on a scale||Standard Deviation|Mean
2744956|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744908|NCT00916617|Primary|Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings|A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.|Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit|The safety population included all participants who received at least 1 dose of study medication in Study NCT00916617.|||Participants|||Number
2744909|NCT00916578|Primary|Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.|The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.|Participants were monitored from 2009 to 2012.|All patients who received protocol - specified treatment.|||participants|||Number
2744910|NCT00916539|Secondary|Range of Motion: Radial Deviation|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
2744911|NCT00916539|Secondary|Range of Motion: Ulnar Deviation|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
2744912|NCT00916539|Secondary|Range of Motion: Extension|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
2744913|NCT00916539|Secondary|Range of Motion: Flexion|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
2744914|NCT00916539|Secondary|Visual Analog Scale for Pain|The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain.|6 months||||units on a scale||Standard Deviation|Mean
2744915|NCT00916539|Secondary|Grip Strength||6 months||||kilograms||Standard Deviation|Mean
2744916|NCT00916539|Secondary|Modified Mayo Wrist Score|The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result.|6 months||||units on a scale||Standard Deviation|Mean
2744917|NCT00916539|Secondary|DASH Questionnaire|This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability).|6 months||||units on a scale||Standard Deviation|Mean
2744918|NCT00916539|Primary|Extent of Union|The investigators looked at the extent of fracture union after immobilization.|10 weeks||||percentage of union||Standard Deviation|Mean
2744919|NCT00916383|Secondary|Safety, Tolerability, and Adhesion|See Adverse Event section for Safety assessment. Adhesion was assessed according to the following scoring criteria: Score 0 = approximately > 90% adhered (essentially no lift off the skin); Score 1 = approximately 75% to < 90% adhered (some edges only lifting off the skin); Score 2 = approximately 50% to < 75% adhered (less than half of the system lifting off the skin); Score of 3 = approximately < 50% adhered but not detached (more than half of the system lifting off the skin without falling off); Score of 4 = Patch-system detached (patch /overlay completely off the skin).|Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.|||||||
2744920|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||participants|||Number
2744921|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.|||participants|||Number
2744922|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||participants|||Number
2744923|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.|||participants|||Number
2745085|NCT00916032|Secondary|Incremental Recovery at Cmax - Chromogenic Assay|Determined as the highest Factor VIII (FVIII) activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2744926|NCT00916383|Primary|Skin Irritation (Erythema and Edema)|Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.|||units on a scale||Standard Deviation|Mean
2744927|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744928|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744929|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744930|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744931|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Overall (0-393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744932|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744933|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744934|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744935|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744936|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744937|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744938|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Late (31 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744939|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Acute/Subacute (0 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745102|NCT00915772|Primary|Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE|Frequency of patients with adverse events by treatment, primary system organ class and preferred term|Baseline and drug stop (up to 54 weeks) + 7 days|Treated Set (TS)|||participants|||Number
2744940|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Subacute (>1 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744941|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per Academic Research Consortium (ARC, definite/probable)|Acute (≤1 day)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744942|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744943|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744944|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744945|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744946|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744947|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744948|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744949|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744950|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744951|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744952|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744953|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR||in-hospital|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744954|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744955|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744957|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744958|NCT00916370|Secondary|Cardiac Death/ All MI|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744959|NCT00916370|Secondary|Cardiac Death/All MI||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744960|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744961|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744962|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744963|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744964|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744965|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744966|NCT00916370|Secondary|All TVR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744967|NCT00916370|Secondary|All TVR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744968|NCT00916370|Secondary|All TVR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744969|NCT00916370|Secondary|All TVR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744970|NCT00916370|Secondary|All TVR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744971|NCT00916370|Secondary|All TVR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744972|NCT00916370|Secondary|All TLR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744973|NCT00916370|Secondary|All TLR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744974|NCT00916370|Secondary|All TLR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744975|NCT00916370|Secondary|All TLR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744976|NCT00916370|Secondary|All TLR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744977|NCT00916370|Secondary|All TLR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744978|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744979|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744980|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744981|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744982|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744983|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744984|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744985|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744986|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744987|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745990|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2744988|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744989|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744990|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744991|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744992|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744993|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744994|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744995|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744996|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744997|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744998|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2744999|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745000|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745001|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745002|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745003|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745004|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745005|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745006|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745007|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||In-hospital is less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745008|NCT00916370|Secondary|Procedural Success (Subject Basis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.|||percentage of participants|||Number
2745009|NCT00916370|Secondary|Device Success (Lesion Basis)|Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.|||percentage of lesions|Participants||Number
2745010|NCT00916370|Secondary|Procedure Time|Procedure time is defined as time between insertion and withdrawal of guide catheter.|From insertion to withdrawal of guide catheter|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.|||Minutes||Standard Deviation|Mean
2745011|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
2745012|NCT00916357|Secondary|Time to Percentage of Insulin Exposure (as Measured by Area Under the Curve [AUC])|Time to percentage of exposure to insulin, as measured by area under the curve (AUC), following a liquid meal for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes following after injection of study drug|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to percentage of insulin exposure as measured by area under the curve (AUC) data.|||Minutes (min)||Standard Deviation|Mean
2745013|NCT00916357|Secondary|Percentage of Participants Without Hypoglycemia|Percentage of participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 who did not experience hypoglycemia following a liquid meal is reported. Hypoglycemia was defined as any blood glucose values lower than 70 milligrams per deciliter (mg/dL) or symptoms of hypoglycemia responding to treatment with glucose. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20.|||Percentage of participants|||Number
2745040|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time|Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745014|NCT00916357|Secondary|Minimum Postprandial Glucose (PPG)|Minimum postprandial glucose (PPG) in participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable minimum postprandial glucose (PPG) data.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2745015|NCT00916357|Secondary|Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG])|Area under the time-concentration curve for blood glucose (AUC[BG]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 following a liquid meal is reported. AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 160 milligrams per deciliter (mg/dL) or 140 mg/dL, or lower than 70 mg/dL within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the time-concentration curve for blood glucose (AUC[BG]) data.|||Milligrams per deciliter * minutes||Standard Deviation|Least Squares Mean
2745016|NCT00916357|Secondary|Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last])|Area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) data.|||Minutes * picomoles /1000 (min*pm/1000)||Standard Deviation|Least Squares Mean
2745017|NCT00916357|Secondary|Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last])|Mean residence time from time 0 to the end of blood sampling (MRT[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable mean residence time from time 0 to the end of blood sampling (MRT[last]) data.|||Minutes (min)||Standard Deviation|Mean
2745018|NCT00916357|Secondary|Time to Late 50% Maximum Serum Insulin Concentration (Late[t50%])|Time to late 50% maximum serum insulin concentration (late[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to late 50% maximum serum insulin concentration (late[t50%]) data.|||Minutes (min)||Standard Deviation|Mean
2745019|NCT00916357|Secondary|Time to Early 50% Maximum Serum Insulin Concentration (Early[t50%])|Time to early 50% maximum serum insulin concentration (early[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, and 120 minutes after injection of each study drug.|Predose up to 120 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to early 50% maximum serum insulin concentration (early[t50%]) data.|||Minutes (min)||Standard Deviation|Mean
2745020|NCT00916357|Secondary|Time To Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (Tmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to maximum serum insulin concentration (Tmax) data.|||Minutes (min)||Standard Deviation|Mean
2745021|NCT00916357|Secondary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least one dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable maximum serum insulin concentration (Cmax) data.|||Picomoles per liter (pm/L)||Standard Deviation|Mean
2745083|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- Chromogenic Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2745022|NCT00916357|Primary|Postprandial Glucose (PPG) Excursion Following a Liquid Meal|Postprandial glucose (PPG) values in participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal are reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least square mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable postprandial glucose (PPG) excursion data.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Least Squares Mean
2745023|NCT00916344|Secondary|Complication Free Rate|"Complication free rate (in %):~1 minus(the number of possibly pacemaker related complications divided by the number of patients)"|1- and 3- month follow-up completed||||Percentage complication free patients||95% Confidence Interval|Number
2745024|NCT00916344|Primary|Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)|"atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.~atrial threshold test: measurable automatically or manually."|1 month follow-up completed|At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis).|||Volt|Participants|95% Confidence Interval|Mean
2745025|NCT00916305|Primary|Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)|Weekly average over the previous month|1 months||||Decibels per week||Standard Deviation|Mean
2745026|NCT00916305|Secondary|Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB|Daily average over the previous month|1 months||||Decibels per day||Standard Deviation|Mean
2745027|NCT00916279|Secondary|Binary Restenosis|Subjects with percent diameter stenosis >50% in the analysis segment.|6 Months|ITT|||participants|||Number
2745028|NCT00916279|Primary|Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months|Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.|6 Months|ITT|||percent diameter stenosis||Standard Deviation|Mean
2745029|NCT00916279|Secondary|MACE Rate|Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).|30 Days|ITT|||Percentage of patients|||Number
2745030|NCT00916279|Secondary|Late Lumen Loss|Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).|6 months|ITT|||(mm)||Standard Deviation|Mean
2745031|NCT00916279|Primary|Percent Diameter Stenosis (%DS) in the Analysis Segment||6 months|ITT|||Percentage stenosis of vessel diameter||Standard Deviation|Mean
2745032|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)|Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
2745033|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE|Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
2745034|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time|Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745035|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy|Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
2745036|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time|Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745037|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy|Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
2745038|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time|Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745039|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy|Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
2770993|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2745041|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy|Change in Verbal Working Memory Accuracy Score (range 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
2745042|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time|Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745043|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy|Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
2745044|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)|Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745045|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy|Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
2745046|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol|Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
2745047|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard|Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745048|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test|Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745049|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency|Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
2745050|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop|Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||seconds||Standard Deviation|Mean
2745051|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency|Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
2745052|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span|Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards.|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745053|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span|Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards.|1 and 11 Weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745054|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS|Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence.|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
2745055|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE|Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. The QOLIE is specific to epilepsy and was only administered in that subject group.|||scores on a scale||Standard Deviation|Mean
2745056|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall|Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745057|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning|Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745058|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning|Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745059|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay|Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745060|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay|Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745061|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning|Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled.|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
2745062|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score|Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across measures.|||scores on a scale||Standard Deviation|Mean
2745063|NCT00916149|Primary|Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment|This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls.|1 and 11 weeks|In a preliminary analysis, data from 11 healthy controls and 6 subjects with partial-onset epilepsy were evaluated.|||IEDs/hour||Standard Deviation|Mean
2745064|NCT00916136|Primary|Time to Pass Guidewire After Attaining Starting Point|Time to pass guidewire across reduced fracture once opening reamer is used in OR|while in Emergency Department (ED) up to 24 hours||||minutes||Standard Deviation|Mean
2745065|NCT00916136|Primary|Difference in the Two Groups in Regards to Resident Time.|Time from consult entered to time traction apparatus is applied.|while in Emergency Department (ED) up to 24 hours||||minutes||95% Confidence Interval|Mean
2745066|NCT00916058|Secondary|Overall Survival at 3 Years (Phase 2)|Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years.|From Day 0 until time of death, assessed up to 3 years.|Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.|||Percentage of participants alive||95% Confidence Interval|Median
2745067|NCT00916058|Secondary|Overall Survival at 2 Years (Phase 1)|Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.|From Day 0 until time of death, assessed up to 2 years.|Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of overall survival, as overall survival is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.|||Percentage of participants alive||95% Confidence Interval|Median
2745068|NCT00916058|Secondary|Progression-Free Survival (Phase 2)|"Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of >25% from lowest response value in any one or more of the following:~Serum M-component and/or (the absolute increase must be > 0.5 g/dL)~Urine M-component and/or (the absolute increase must be > 200 mg/24 h)~Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be > 10 mg/dL~Bone marrow plasma cell percentage; the absolute percentage must be > 10%~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder"|From Day 0 to first incidence of disease progression, up to 86 months|Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.|||Months||95% Confidence Interval|Median
2745084|NCT00916032|Secondary|Incremental Recovery at Cmax - One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2745069|NCT00916058|Secondary|Progression-Free Survival (Phase 1)|"Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of >25% from lowest response value in any one or more of the following:~Serum M-component and/or (the absolute increase must be > 0.5 g/dL)~Urine M-component and/or (the absolute increase must be > 200 mg/24 h)~Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be > 10 mg/dL~Bone marrow plasma cell percentage; the absolute percentage must be > 10%~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder"|From Day 0 to first incidence of disease progression, up to 1,128 days|Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of progression-free survival (PFS), as PFS is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.|||Days||95% Confidence Interval|Median
2745070|NCT00916058|Primary|Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant|Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required|100 days post-transplant|Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.|||Participants|||Count of Participants
2745071|NCT00916058|Primary|Maximum Tolerated Dose (Phase 1)|The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm^3 and platelet count of 20,000/mm^3 untransfused by Day 35 post-transplant.|35 days post-transplant|Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6).|||Participants|||Count of Participants
2745072|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||IU/dL||Standard Deviation|Mean
2745073|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||IU/dL||Standard Deviation|Mean
2745074|NCT00916032|Secondary|Volume of Distribution at Steady State- One-stage aPTT Assay|computed as CL * MRT|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||dL/kg||Standard Deviation|Mean
2745075|NCT00916032|Secondary|Volume of Distribution at Steady State- Chromogenic Assay|computed as Clearance (CL) * Mean residence time (MRT)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||dL/kg||Standard Deviation|Mean
2745076|NCT00916032|Secondary|Mean Residence Time (MRT)- One-stage aPTT Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||hour||Standard Deviation|Mean
2745077|NCT00916032|Secondary|Mean Residence Time (MRT)- Chromogenic Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||hour||Standard Deviation|Mean
2745078|NCT00916032|Secondary|FVIII Clearance- One-stage aPTT Assay|Computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||mL/(kg·h)||Standard Deviation|Mean
2745079|NCT00916032|Secondary|FVIII Clearance- Chromogenic Assay|computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||mL/(kg·h)||Standard Deviation|Mean
2745080|NCT00916032|Secondary|Elimination Phase Half-life- One-stage aPTT Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.||||hour||Standard Deviation|Mean
2745081|NCT00916032|Secondary|Elimination Phase Half-life- Chromogenic Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.||||hour||Standard Deviation|Mean
2745082|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- One-stage aPTT Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2745086|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
2745087|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
2745088|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
2745089|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
2745090|NCT00916006|Secondary|Patients With Partial Clearance of Actinic Keratosis (AK)|Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population|||participants|||Number
2745091|NCT00916006|Primary|Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.|Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population|||participants|||Number
2745092|NCT00915967|Primary|Incidence of Infection That Requires Removal of the Neurosurgical Device|The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.|Six months post-operation||||Participants|||Count of Participants
2745093|NCT00915954|Secondary|Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing|Bioactive IGF-1 levels were measured at time 0 prior to the injection and measured at 15, 30, 60, 90, 120, and 180 minutes after injection. The area under the curve of bioactive IGF-1 was calculated for each subject and the medians calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.|Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.||||ng*min/mL||Full Range|Median
2745094|NCT00915954|Secondary|Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing|Insulin levels were measured at time 120 minutes after injection. Median insulin was calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.|Measured at 120 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.||||mU/L||Full Range|Median
2745095|NCT00915954|Secondary|Median Insulin Like Growth Factor Binding Protein 1 (IGFBP-1) Area Under the Curve in Response to Placebo, Oral Glucose Tolerance Test (OGTT), and rhIGF1 Suppression Testing|IGFBP1 levels were measured at time 0 prior to the injection and measured at 15, 30, 60, 90, 120, and 180 minutes after injection. The area under the curve of IGFBP1 was calculated for each subject and the medians calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.|Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.||||ng*min/mL||Full Range|Median
2745096|NCT00915954|Primary|Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml|Subjects underwent recombinant insulin like growth factor 1 (rhIGF1) suppression testing and growth hormone levels were measured at time 0, 15, 30, 60, 90, 120, and 180 minutes after injection of rhIGF-1. A response </= 0.4 ng/ml is considered a normal response in the healthy control and diabetic control subjects. The percentage of subjects with a normal GH suppression to </= 0.4 ng/ml was calculated.|Before injection and at time 15, 30, 60, 90, 120 and 180 minutes after rhIGF-1 injection on week 4||||Participants|||Count of Participants
2745097|NCT00915902|Primary|Change in Triglyceride Level||after 8 week treatment or placebo period||||mg/dL||Standard Deviation|Mean
2745098|NCT00915876|Primary|Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56|Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56|Day 28 and Day 56||||nanogram/ml||Standard Deviation|Mean
2745099|NCT00915798|Secondary|Salivary Cotinine|Average level of salivary cotinine over all time points (microgram/milliliter)|Once per week for 4 weeks|Discrepancies between participants cotinine samples and participant flow are due to the fact that not all participants provided useful saliva samples.|||Microgram/milliliter||Standard Deviation|Mean
2745100|NCT00915798|Secondary|DRD4 Genotype||one time blood draw|Discrepancies between participant flow and data analyze reflect that not all participants provided blood samples. Dopamine genotypes were only available for participants who were also enrolled in the Multimodal Treatment for ADHD Study (MTA-Study).|||Participants|||Count of Participants
2745101|NCT00915798|Primary|Brain Activity|BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.|One MRI session for nonsmokers and two MRI sessions for smokers|Discrepancies between participant flow and number of participants analyzed are due to motion artifacts, which compromised the MRI findings. Thus, a number of participants had to be excluded from the MRI data analysis.|||z-score||Standard Deviation|Mean
2745103|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).|78 weeks|Non-switcher set (OC) with non-missing data at visit. Only patients who continued on the same treatment in both studies are included|||Percentage||Standard Deviation|Mean
2745104|NCT00915772|Secondary|Number of Patients With Rescue Therapy||54 weeks|TS|||Number of patients|||Number
2745105|NCT00915772|Secondary|Change in FPG From Baseline Over Time|Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit|||mg/dL||Standard Deviation|Mean
2745106|NCT00915772|Secondary|Number of Patients With HbA1c of at Least <0.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)|||participant|||Number
2745107|NCT00915772|Secondary|Number of Patients With HbA1c <6.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)|||participant|||Number
2745108|NCT00915772|Secondary|Number of Patients With HbA1c <7.0% After 54 Weeks||54 weeks|Treated Set with non completers considered as failures (NCF)|||participant|||Number
2745109|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit|||Percentage||Standard Deviation|Mean
2745110|NCT00915772|Primary|Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry|ULN means upper limit of normal|54 weeks|TS and observed cases (OC). In treatment group L2.5+M500, the number of patients analysed was 224 for lactate dehydrogenase abnormality and total bilirubin abnormality due to anailable data.|||participants|||Number
2745111|NCT00915772|Primary|Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology||54 weeks|TS and observed cases (OC)|||participants|||Number
2745112|NCT00915772|Primary|Change From Baseline at Week 54 in Pulse Rate|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)|||beats per minute (bpm)||Standard Deviation|Mean
2745113|NCT00915772|Primary|Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)|||mmHg||Standard Deviation|Mean
2745114|NCT00915772|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|54 weeks|Treated Set (TS): all screened patients who were documented to have taken at lease 1 dose of study drug.|||participant|||Number
2745115|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1.|||days to complete re-epithelialization|Participants|Standard Deviation|Mean
2745116|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3.|||days to complete re-epithelialization|Participants|Standard Deviation|Mean
2745117|NCT00915759|Secondary|Tear Protein Analysis||up to 1 month post-operatively||2013-12-31|12/2013||||
2745118|NCT00915759|Secondary|Corneal Clarity||one year postoperatively||2013-12-31|12/2013||||
2745119|NCT00915759|Secondary|Long-term Visual Outcomes||one year post-operatively||2013-12-31|12/2013||||
2745120|NCT00915759|Secondary|Visual Recovery||one year post-operatively||2013-12-31|12/2013||||
2745121|NCT00915759|Secondary|Complications/Adverse Events||one year post-operatively||2013-12-31|12/2013||||
2745122|NCT00915759|Secondary|Post-operative Pain|measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)|measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively||2013-12-31|12/2013||||
2745123|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-repithelialization (healing).|||days to complete re-epithelialization|Participants|Standard Deviation|Mean
2745124|NCT00915655|Secondary|Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]|The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable).|Week 24|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2745125|NCT00915655|Primary|Virological Response[Viral Load <50 Copies/mL, TLOVR]|The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.|Week 24|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2745126|NCT00915603|Secondary|Overall Survival (OS)|Assessed from Day 1 of study drug administration to date of death due to any cause.|every 8 weeks until treatment discontinuation, expected average 6 months||||months||95% Confidence Interval|Median
2745183|NCT00915473|Secondary|Mean Number of Days With Acute Medication Use|"Acute medication use meant the consumption of a drug to abort or terminate a headache."|4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||days per 4 weeks||Standard Deviation|Mean
2745127|NCT00915603|Secondary|Duration of Response (DOR)|Defined as time between date of objective response and date of response to disease progression or death, as defined by RECIST v1.1 criteria. Objective response is defined as either complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until treatment discontinuation, expected average 6 months||||months||95% Confidence Interval|Median
2745128|NCT00915603|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 8 weeks until treatment discontinuation, expected average of 18 months|Includes patients who were enrolled and randomized|||participants|||Number
2745129|NCT00915603|Secondary|Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability|Assessments will be made based on the analysis of reported incidence of treatment-emergent AEs|every 4 weeks until intolerable toxicity occurs|Includes patients who were enrolled, randomized and treated|||participants|||Number
2745130|NCT00915603|Primary|Progression-Free Survival (PFS)|Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months|Includes all enrolled and randomized patients|||months||95% Confidence Interval|Median
2745131|NCT00915590|Secondary|Central Corneal Thickness|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
2745132|NCT00915590|Secondary|Best Spectacle-Corrected Visual Acuity (BSCVA)|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
2745133|NCT00915590|Primary|Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
2745134|NCT00915590|Primary|Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
2745135|NCT00915590|Primary|Extent of Neovascular Area (NA)|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
2745136|NCT00915590|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.|64 Weeks||||participants|||Number
2745137|NCT00915551|Secondary|Partial Clearance of Actinic Keratoses (AK)|Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population|||participants|||Number
2745138|NCT00915551|Primary|Complete Clearance of Actinic Keratoses (AK) Lesions|Complete clearance of the treatment field|baseline and 57 days|Intention to treat population|||participants|||Number
2745184|NCT00915473|Secondary|Mean Number of Hours With Moderate or Severe Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||hours per 4 weeks||Standard Deviation|Mean
2745185|NCT00915473|Secondary|Mean Frequency of Days With a Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||days per 4 weeks||Standard Deviation|Mean
2745991|NCT00909610|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745139|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745140|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745141|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745142|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745143|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745144|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745145|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745992|NCT00909610|Primary|AUC0-72 for Baseline Corrected Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2745146|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745147|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745148|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745149|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745150|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745151|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745152|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745153|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745154|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745155|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745156|NCT00915525|Secondary|Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745157|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745158|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745159|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745160|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745161|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745162|NCT00915525|Secondary|Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2745163|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745164|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745165|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745166|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745186|NCT00915473|Primary|Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period|The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.|4 weeks pre-injection baseline, 4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||participants|||Number
2745167|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745168|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
2745169|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|"The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either greatly improved or improved are considered to have a positive response."|Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
2745170|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|"The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either greatly improved or improved are considered to have a positive response."|Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
2745171|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|"The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either greatly improved or improved are considered to have a positive response."|Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
2745172|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|"The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either greatly improved or improved are considered to have a positive response."|Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
2745173|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|"The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either greatly improved or improved are considered to have a positive response."|Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
2745174|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)|"The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either greatly improved or improved are considered to have a positive response."|Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
2745187|NCT00915356|Secondary|Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion|Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion|Six hours following start of study drug infusion||||Percent of participants||95% Confidence Interval|Number
2745175|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2745176|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2745177|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2745178|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2745179|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2745180|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2745181|NCT00915499|Secondary|Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)|Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.|3 months||||units on a scale||Standard Deviation|Mean
2745182|NCT00915499|Primary|Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period|AHI refers to the number of apneas and hypopneas that occurred per hour of sleep|3 months||||AHI (events/hour)||Standard Deviation|Mean
2770994|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2745188|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months|Subgroup analysis for patients with duration of current AF episode 31 days - 3 months. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion||||Participants|||Number
2745189|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.|Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion||||Participants|||Number
2745190|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days||Conversion from AF to SR within 90 minutes from start of infusion||||Participants|||Number
2745191|NCT00915356|Secondary|Maximal Observed Plasma Concentration of AZD1305|Plasma concentration of AZD1305|Up to 24 hours following start of study drug infusion||||mol/L||Full Range|Median
2745192|NCT00915356|Secondary|Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.||Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.|||||||
2745193|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.|Number of patients in SR at day 13-18|During 13 to 18 days following study drug infusion||||Participants|||Number
2745194|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion||During 24 hours following start of study drug infusion||||Participants|||Number
2745195|NCT00915356|Secondary|Heart Rhythm. Number of Participants With Early Relapse Into AF.|Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.|Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR||||Participants|||Number
2745196|NCT00915356|Secondary|Wide QRS Tachycardias|Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).|From start of study drug infusion until discharge from hospital on study day 2.||||Participants|||Number
2745197|NCT00915356|Primary|Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)|Conversion of AF to SR with maintenance of SR maintained for at least 1 minute|Within 90 minutes from start of infusion||||Percentage of patients converted to SR||95% Confidence Interval|Number
2745198|NCT00915356|Primary|Dose-response Relationship for QTcF Interval of AZD1305|QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date & time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed|At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).||||ms||95% Confidence Interval|Mean
2745199|NCT00915343|Secondary|Comparison on 24-hour Urinary Free Cortisol Between Once Daily and Thrice Daily Therapy-Part A||12 weeks|Part A Safety population consisted of all randomised patients who took at least one dose of study medication. Safety population with participants evaluable for this outcome.|||nanomoles per 24 hours||Standard Deviation|Mean
2745200|NCT00915343|Secondary|Comparison on Participant Preference by Questionnaire Between Once Daily and Thrice Daily Therapy-Part A|"Participant Preference Questionnaire consisted of the following set of questions:~1. How large was the benefit with OD compared to TID and the responses were recorded as considerably poorer, somewhat poorer, comparable, large, very large; 2. How strongly concur with the following statement: I prefer novel OD to conventional TID and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly; 3. How strongly concur with the following statement: I prefer conventional TID to novel OD and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly."|Weeks 16 up to 28|Part A ITT population|||percentage of preference|||Number
2745201|NCT00915343|Secondary|Participant Compliance- Part B|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets - Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Up to Month 6 follow-up|Part B ITT population with participants evaluable for this outcome.|||percentage use||Standard Deviation|Mean
2745202|NCT00915343|Secondary|Comparison on Participant Compliance Between Once Daily and Thrice Daily Therapy - Part A|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets - Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Weeks 4 up to 28|Part A ITT population with participants evaluable for this outcome.|||percentage use||Standard Deviation|Mean
2745203|NCT00915343|Secondary|Change From Baseline to 6 Months in Diurnal Fatigue Questionnaire for Day Average- Part B|Diurnal fatigue scores (Visual Analog Scale [VAS] scores of energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745255|NCT00915278|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CL.|||Liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2745204|NCT00915343|Secondary|Change From Baseline to 12 Weeks in Diurnal Fatigue Questionnaire for Day Average of Once Daily Therapy - Part A|Diurnal fatigue was assessed at 8 ante meridian (AM), at 12 AM and at 4 post meridian (PM) by a visual analogue scale (VAS) based on 8 domains (energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity). Mean values were calculated for the morning (8 AM), the day (12 AM), the evening (4 PM) and mean per day (mean of 8 AM, 12 AM and 4 PM) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), Week 12|ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745205|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores- Part B|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745206|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores Between Once Daily and Thrice Daily Therapy- Part A|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745207|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score - Part B|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745208|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score Between Once Daily and Thrice Daily Therapy - Part A|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745209|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score - Part B|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value in the SF-36 questionnaire corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745210|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score Between Once Daily and Thrice Daily Therapy- Part A|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
2745211|NCT00915343|Secondary|Percentage (%) of Participants With Change From Baseline in Patient Tolerability Questionnaire at Month 6, Assessed by Patient and Investigator - Part B|Patient tolerability questionnaire was assessed by both patient and investigator, the responses were as follows: improvement, no change, worsening and were reported.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||percentage of participants|||Number
2745212|NCT00915343|Secondary|Comparison of Overall Patient Tolerability Score Between Once Daily and Thrice Daily Therapy, Assessed by Patient and Investigator - Part A|"Overall patient tolerability score assessed by patient and investigator, ranged from 1 (feeling poor on treatment) to 5 (feeling very well on treatment). The average total score ranges from 1 to 5 with a higher score representing better tolerability of the treatment.~Questionnaire assessed by patient were I have been very poorly on the treatment, I haven't been very well (or less well) on the treatment, I have been acceptably well on the treatment, I have been well on the treatment and I have been very well on the treatment. Questionnaire assessed by investigator were The patient has been feeling very poorly on the treatment, The patient has not tolerated the treatment well, The patient has tolerated the treatment less well, The patient has tolerated the treatment well and The patient has tolerated the treatment very well."|12 weeks|Part A ITT population|||scores on a scale||Standard Deviation|Mean
2745213|NCT00915343|Secondary|Accumulation Ratio (Rac) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The Rac was calculated as area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) on Day 28 divided by AUC0-24h on Day 1. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||ratio||Standard Deviation|Mean
2745214|NCT00915343|Secondary|Percentage (%) of Fluctuation in Concentrations of S-cortisol at Steady State in Plasma After Single and Multiple Dosing During Part A|Percentage of fluctuation was calculated by using formula 100*(Cmax-minimum plasma concentration [Cmin])/Cavg,ss. It was peak trough fluctuation within one dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||percentage of fluctuation||Standard Deviation|Mean
2745215|NCT00915343|Secondary|Percentage (%) of Area Under the Concentration Time Curve (AUC) Extrapolation of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) was calculated by using the formula AUC%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter was to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t). Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||percentage of AUC||Standard Deviation|Mean
2745216|NCT00915343|Secondary|First Detectable Concentration Adjusted by Dose (Cfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||per liter||Standard Deviation|Mean
2745217|NCT00915343|Secondary|Time to First Detectable Concentration Adjusted by Dose (Tfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||(hour per nanomole)*10^6||Standard Deviation|Mean
2745218|NCT00915343|Secondary|Maximal Concentration Adjusted by Dose (Cmax1/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||per liter||Standard Deviation|Mean
2745219|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State Adjusted by Dose (Css,av/Dose) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||per liter||Standard Deviation|Mean
2745220|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 4 Hours Adjusted by Dose (AUC0-4h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
2745221|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 10 Hours Adjusted by Dose (AUC0-10h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
2745222|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 24 Hours Adjusted by Dose (AUC0-24h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
2745223|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State Adjusted by Dose (AUCtau/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 14 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
2745224|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State (AUCtau) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUCtau is defined as AUC during a dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour*nanomole per liter||Standard Deviation|Mean
2745225|NCT00915343|Secondary|Area Under the Concentration Time Curve (AUC) Between Specified Timepoints of Total S-cortisol in Plasma After Single and Multiple Dosing During Part A|"AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUC between specified timepoints included AUC0-4h, AUC4-12h, AUC6-12h, AUC12-24h, AUC0-10h, AUC4-10h, AUC6-10h, AUC10-24h, AUC(0-inf), AUC(24h-inf). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. Here, Nsignifies the number of participants evaluable for this outcome."|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population.|||hour*nanomole per liter||Standard Deviation|Mean
2745226|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 14 Hours (t1/2[5-14h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-14h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 14 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Standard Deviation|Mean
2745227|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 24 Hours (t1/2[5-24h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-24h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 24 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Standard Deviation|Mean
2745228|NCT00915343|Secondary|Time to Reach a Concentration of 200 Nanometers (nM) (T200) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
2745229|NCT00915343|Secondary|Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
2745993|NCT00909610|Primary|Cmax for Baseline Corrected Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745230|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
2745231|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
2745232|NCT00915343|Secondary|Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
2745233|NCT00915343|Secondary|Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
2745234|NCT00915343|Secondary|First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
2745235|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
2745236|NCT00915343|Secondary|Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
2745237|NCT00915343|Secondary|Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
2745254|NCT00915278|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Vss.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2745238|NCT00915343|Primary|Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A: Intention-To-Treat (ITT) set included all randomised participants who took at least 1 dose of study drug with primary efficacy assessments including all pharmacokinetic (PK) samplings during either treatment period. Here “number of participants analysed” signifies those who were evaluable for the outcome measure.|||hour*nanomole per liter||Standard Deviation|Mean
2745239|NCT00915278|Secondary|Number of Participants With Perforin Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Perforin.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745240|NCT00915278|Secondary|Number of Participants With Ki67 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Ki67.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745241|NCT00915278|Secondary|Number of Participants With Caspase 3 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Caspase 3.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745242|NCT00915278|Secondary|Number of Participants With CD31 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD31.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745243|NCT00915278|Secondary|Number of Participants With pFAK Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against pFAK.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745244|NCT00915278|Secondary|Number of Participants With CD16 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD16.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD16 expression.|||Participants|||Number
2745245|NCT00915278|Secondary|Number of Participants With CD56 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD56.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD56 expression.|||Participants|||Number
2745246|NCT00915278|Secondary|Number of Participants With Granzyme B Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Granzyme B.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745247|NCT00915278|Secondary|Number of Participants With CD68 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies CD68.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745248|NCT00915278|Secondary|Number of Participants With Integrin Alpha 5 Beta 1 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against integrin alpha 5 beta 1.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745249|NCT00915278|Secondary|Number of Participants With Tissue Macrophage Infiltration|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against tissue macrophages.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
2745250|NCT00915278|Secondary|Percent Change in Initial Area Under the Curve (IAUC)|Percent change in the IAUC for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 Day 15. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.||||||
2745251|NCT00915278|Secondary|Percent Change in Transfer Constant (Ktrans) From Baseline to Cycle 1 Day 15|Percent change in Ktrans for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 day 15 aimed at defining the effect of PF-04605412 on tumor vasculature.|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.||||||
2745252|NCT00915278|Secondary|Objective Response - Number of Participants With Objective Response|"Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.~Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions."|Baseline up to 6 weeks after the first infusion of PF-04605412 (end of Cycle 2) and approximately every 6 weeks thereafter only in the absence of progressive disease|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.|||participants|||Number
2745253|NCT00915278|Secondary|Number of Participants Positive for Anti-PF04605412 Antibodies|Serum samples were analyzed for anti-drug antibodies (ADA) or human anti-human antibodies (HAHA). This was used to evaluate immunogenicity.|Baseline up to end of treatment|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.|||participants|||Number
2745256|NCT00915278|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Tmax.|||hours||Full Range|Median
2745257|NCT00915278|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable t1/2.|||hours||Standard Deviation|Mean
2745258|NCT00915278|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]|AUC (0 - inf)= Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUC (0 - inf).|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2745259|NCT00915278|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUClast.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2745260|NCT00915278|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Cmax.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2745261|NCT00915278|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any >= Grade 3 adverse event (AE) graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF‑04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.|Baseline up to 6 weeks PF-04605412|All subjects enrolled in the dose escalation part of the study who received at least one dose of study medication that remained on study and/or provided safety follow-up for at least 6 weeks, unless discontinuing due to a DLT. Subjects discontinuing the study due to DLT are included|||participants|||Number
2745262|NCT00915148|Secondary|Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)||6 hours post determination of prolonged labor||||percentage of participants|||Number
2745263|NCT00915148|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound|Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.|during labor||||percentage probability||95% Confidence Interval|Number
2745264|NCT00915031|Primary|Feasibility and Safety Using an Improved, More Efficient and Less Labor Intensive Cooling Balloon in Patients Undergoing Hypothermic Nerve-sparing RLP in Participants Determined by Return to Continence|The primary aim is confirmation of the feasibility and safety using an improved, more efficient and less labor intensive cooling balloon in patients undergoing hypothermic nerve-sparing RLP. Continence is defined as no protective urinary pad use as reported by the patient in response to the very first question on page 1 of the sample questionnaire.|During and 6 hours post surgery||||Participants|||Count of Participants
2745265|NCT00915018|Secondary|Symptomatic or Progressive Central Nervous System (CNS) Lesions|"Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.~If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead."|From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years|all randomized patients|||Participants|||Count of Participants
2745266|NCT00915018|Secondary|Clinical Benefit Rate|Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From randomization to disease progression or death, assessed up to 5.3 years|all randomized patients|||percentage of participants||95% Confidence Interval|Number
2745267|NCT00915018|Secondary|Duration of Response|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first response to first PD or death, assessed up to 5.3 years after first subject randomized|patients who responded|||months||95% Confidence Interval|Median
2745268|NCT00915018|Secondary|Objective Response Rate|Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.|From randomization to disease progression or last tumor assessment, assessed up to 5.3 years|all randomized patients|||percentage of participants||95% Confidence Interval|Number
2745269|NCT00915018|Primary|Progression-Free Survival|Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.|From randomization to disease progression or death, assessed up to 5.3 years|all randomized patients|||months||95% Confidence Interval|Median
2745270|NCT00914966|Secondary|Use of Rescue Therapy and/or Other Therapy for Treatment of HAE Symptoms||12 weeks at each dose level|||||||
2745271|NCT00914966|Secondary|Treatment Effect of Escalating Doses of CINRYZE on HAE Attack Rates|"Two definitions of success were applied in this study:~Per-protocol success - Average angioedema attack rate of ≤1.0 per month at the end of any dose escalation step (Week 12). The a priori definition of study success was 4 or more subjects with per-protocol success.~Investigator-determined success - Based on the investigator's clinical judgment, an average monthly angioedema attack rate demonstrating improvement sufficient for progression to follow-up.~In addition, subjects who were not a per-protocol or investigator-determined success, but who experienced a reduction of >1.0 attack per month from their historical angioedema attack rate at the end of any dose escalation step (Week 12), were summarized."|12 weeks at each dose level||||participants|||Number
2745272|NCT00914966|Primary|Number of Subjects With Adverse Events, Hospitalizations, Thrombotic Events, Treatment-emergent C1 INH Antibodies, Post-baseline Toxicity Grade Increases in Clinical Laboratory Parameters, and Post-dose Vital Signs Changes of Potential Clinical Importance|Events reported during the 3 month follow-up period are counted with the dose level at which they occurred.|12 to 24 weeks at each dose level||||participants|||Number
2745273|NCT00914927|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 4 (Visit 3) and Day 8 (Visit 5, EOT)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
2745274|NCT00914927|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 4 (Visit 3)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
2745275|NCT00914927|Secondary|Percentage of Participants Experiencing Dose-response by Visit|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 4 (Visit 3), Day 6 ( Visit 4), Day 8 (Visit 5, EOT), 3 Day Post Last Dose (Visit 6), and 7 Day Post Last Dose (Visit 7)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
2745276|NCT00914927|Secondary|Change in Platelet Count on Day 8 (Visit 5 and/or End of Treatment) From Baseline|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 8 (Visit 5, EOT)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||K/mm^3||Standard Deviation|Mean
2745312|NCT00914485|Primary|Change in Provider Use of Best Acts From Baseline to Post-Intervention|"Mean per-patient use of best acts learned during provider communication skills intervention, post-intervention minus baseline."|Baseline, 18 months||||best acts per patient||Standard Deviation|Mean
2745277|NCT00914927|Primary|Percentage of Participants Experiencing Response|Platelet counts (PC) were determined from blood draws. A responder is defined as a participant having an increase of at least 20,000/mm^3 PC from Baseline and a PC greater than 50,000/mm^3 at least once during Day 4 through Day 8. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (end of treatment (EOT)), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 8 (Visit 5, EOT)|Intent-to-treat (ITT) population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
2745278|NCT00914862|Secondary|Number of Participants With Clinically Significant Physical Examination Results|A complete physical examination was performed for each participant at Screening, Check-in (Day 1), Day 2, and Final Visit (Day 4) or Early Termination. The examination consisted of a review of the following body systems: eyes; ears, nose, and throat; respiratory; gastrointestinal; extremities; musculoskeletal; cardiovascular; nervous; and dermatological.|Screening, Day 1, Day 2 and Day 4|Safety set.|||participants|||Number
2745279|NCT00914862|Secondary|Number of Participants With Clinically Significant Electrocardiogram Findings|A standard 12-lead electrocardiogram (ECG) was recorded at Screening, Day 2, and at Final Visit (Day 4). The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Screening, Day 2 and Day 4|Safety set.|||participants|||Number
2745280|NCT00914862|Secondary|Number of Participants With Clinically Significant Vital Signs|Vital signs included oral body temperature, pulse and blood pressure (taken after 5 minutes in the sitting position). Vital signs measurements were determined to be clinically significant according to predefined criteria.|Screening, Day 1, Day 2 and Day 4|Safety set.|||participants|||Number
2745281|NCT00914862|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Laboratory samples were collected at Screening, Check-in (Day 1), and Day 2 or Early Termination for assessment of hematology, chemistry, and urinalysis.|Screening, Day 1, Day 2 and Day 4|Safety set.|||participants|||Number
2745282|NCT00914862|Secondary|Number of Participants With Adverse Events (AE)|"An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows:~Mild: The event was transient and easily tolerated by the participant.~Moderate: The event causes the participant discomfort and interrupted usual activities.~Severe: The event causes considerable interference with the participant's usual activities."|Day 1 to Day 15|The safety set includes all participants who received at least 1 dose of study drug.|||participants|||Number
2745283|NCT00914862|Primary|Apparent Volume of Distribution (Vz/F)|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||Liters||Standard Deviation|Mean
2745284|NCT00914862|Primary|Terminal Elimination Half-life (T1/2)|Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln[2]) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||hours||Standard Deviation|Mean
2745285|NCT00914862|Primary|Terminal Elimination Rate Constant (λz)|The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||1/hour||Standard Deviation|Mean
2745286|NCT00914862|Primary|Apparent Clearance After Oral Administration (CL/F)|"Apparent oral clearance of drug from the serum calculated as:~CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf])."|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||L/hr||Standard Deviation|Mean
2745287|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])|Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||ng*hr/mL||Standard Deviation|Mean
2745288|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])|Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||ng*hr/mL||Standard Deviation|Mean
2745289|NCT00914862|Primary|Time to Reach Maximum Serum Concentration (Tmax)|Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||hours||Full Range|Median
2746289|NCT00907218|Secondary|Exhaled CO Levels|At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.|Weekly over 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2745290|NCT00914862|Primary|Maximum Observed Serum Concentration (Cmax)|Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|The Pharmacokinetic (PK) set, which consisted of all patients who received study drug and had sufficient concentration data to calculate at least 1 PK parameter.|||ng/mL||Standard Deviation|Mean
2745291|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure||Up to Day 2||||participants|||Number
2745292|NCT00914849|Secondary|Rate of Chronic GVHD in Recipients||Day 101-1 year|8 patients are not evaluable because they were not alive for the outcome measure time frame.|||participants|||Number
2745293|NCT00914849|Secondary|Grade 3-4 Toxicity for Recipients|Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.|1 year||||participants|||Number
2745294|NCT00914849|Secondary|Transplant Related Mortality Rate for Recipients|Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.|Day 100||||participants|||Number
2745295|NCT00914849|Secondary|Time to Platelet Engraftment for Recipients|Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.|Up to Day 100||||days||Full Range|Median
2745296|NCT00914849|Secondary|Time to Neutrophil Engraftment for Recipients|Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.|Up through Day 100||||days||Full Range|Median
2745297|NCT00914849|Secondary|Rate of Acute GVHD (Grade III-IV) in Recipients||Day 0-Day 100 (acute)||||participants|||Number
2745298|NCT00914849|Secondary|Rate of Acute GVHD (Grade II-IV) in Recipients||Day 0-Day 100 (acute)||||participants|||Number
2745299|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)||Day 1 and Day 2||||hr.ng/mL||Standard Deviation|Mean
2745300|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Half Life|"-Blood samples for pharmacokinetics were drawn on the following schedule:~prior to IV infusion~15 minutes after start of infusion~30 minutes after start of infusion~1 hour after start of infusion~4 hours after start of infusion~6 hours after start of infusion~9 hours after start of infusion~24 hours after start of infusion"|Day 1 and Day 2||||hours||Standard Deviation|Mean
2745301|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)|"-Blood samples for pharmacokinetics were drawn on the following schedule:~prior to IV infusion~15 minutes after start of infusion~30 minutes after start of infusion~1 hour after start of infusion~4 hours after start of infusion~6 hours after start of infusion~9 hours after start of infusion~24 hours after start of infusion"|Day 1 and Day 2||||ng/mL||Standard Deviation|Mean
2745302|NCT00914849|Secondary|Number of Recipients Who Have Neutrophil Engraftment||Day 21||||participants|||Number
2745303|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Infusional Toxicity||Up to Day 2||||participants|||Number
2745304|NCT00914849|Primary|Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant||Completion of enrollment of all donors (17 months)|3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection.|||participants|||Number
2745305|NCT00914810|Secondary|Change in Blood Level of Vitamin D (25-hydroxyvitamin D)||Baseline and 6 weeks|25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.|||ng/mL||Standard Deviation|Mean
2745306|NCT00914810|Primary|Change in Short Physical Performance Battery (SPPB) Score|SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.|Baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
2745307|NCT00914589|Secondary|Percentage of Subjects With Serious Adverse Events|Percentage of subjects with serious adverse events until end of trial.|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.|||percentage (%) of subjects|||Number
2745308|NCT00914589|Secondary|Percentage of Subjects With Critical Adverse Events|Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.|||percentage (%) of subjects|||Number
2745309|NCT00914589|Secondary|Percentage of Subjects With rFXIII Antibody Reaction|Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.|measured from screening until 5-7 weeks post Trial Drug Administration|Safety analysis set includes all subj. exposed to at least one dose of trial product. 1 subj with a low titre antibody at baseline was also reported with low titre FXIII antibody at visit 8. 27, 19 and 17 subjects in placebo, FXIII 17.5 and 35 IU/KG, respectively, did not have antibody measurement.|||participants|||Number
2745310|NCT00914589|Secondary|Percentage of Subjects With Thromboembolic Events|Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.|||percentage of subjects|||Number
2745311|NCT00914589|Primary|Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First|Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.|measured ongoing from dosing until day 7 or discharge, whichever came first|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment.|||percentage (%) of subjects|||Number
2745313|NCT00914459|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): All Participants|An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 30 days after last study visit (Month 25)|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||participants|||Number
2745314|NCT00914459|Secondary|Mean Residence Time (MRT) of ReFacto AF|MRT was calculated as AUMCinf / AUCinf-TI/2, where AUMCinf is the area under the first moment curve from time zero to infinity and TI was the duration of infusion.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||hour||Full Range|Median
2745315|NCT00914459|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2745316|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)|AUClast is the area under the plasma versus time curve from time zero to time of last measurable concentration (AUClast)|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2745317|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was calculated as International units*hour per milliliter (IU*hr/mL).|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2745318|NCT00914459|Secondary|Plasma Concentration of Factor VIII at 0.5 Hour Post-dose (C0.5)||0.5 hour post-dose on Day 1|The PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2745319|NCT00914459|Secondary|Number of Participants Requiring Escalated Dose of Prescribed Regimen During the Treatment Period: All Participants|Participants who met the dose escalation criteria were prescribed a higher dose and/or more frequent doses as per the investigator's discretion.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who used a prophylaxis regimen were analyzed for this outcome measure.|||participants|||Number
2745320|NCT00914459|Secondary|Number of Occurrences of Less-Than-Expected-Therapeutic Effect (LETE) in the Low Recovery Setting: All Participants|LETE in the low recovery setting was defined as lower than expected recovery of FVIII (in the opinion of investigator), following the infusion of ReFacto AF in the absence of confounding factors for the low recovery. The only confounding factors for low recovery are as follows: known presence or subsequent identification of a FVIII inhibitor, known compromised ReFacto AF, faulty administration of ReFacto AF, including inadequate dosing.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||LETE bleeds|||Number
2745321|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the Prophylaxis Setting: All Participants|LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (<=48 hours) after a regularly scheduled prophylactic dose of ReFacto AF (which was not used to treat a bleed) in the absence of confounding factors. Therefore, LETE in the prophylaxis setting is the occurrence of a bleed. Confounding factors include: Known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose, known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised ReFacto AF, faulty administration of ReFacto AF, an underlying, predisposing condition responsible for the bleed in the opinion of the investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs) or traumatic injury responsible for bleeding.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who received at least 1 prophylaxis dose of ReFacto AF were reported.|||LETE bleeds|prophylaxis infusions||Number
2745330|NCT00914459|Primary|Terminal Elimination Half Life of ReFacto AF (t1/2)|T1/2 was the time for the plasma concentration of drug to decrease by one-half of its original concentration.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||hours||Standard Deviation|Mean
2745322|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the On-Demand Setting: All Participants|"LETE in on-demand setting was based on response to treatment of a bleeding episode. LETE in the on-demand setting occurred if participant recorded 2 successive no response ratings after 2 successive ReFacto AF infusions. Both infusions were to be administered at an interval of 24 hours for treatment of same bleeding event in absence of confounding factor which included: known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of greater than 4 hours between onset of bleed to infusion, delay of greater than 24 hours before administration of a follow-up infusion, known compromised ReFacto AF, faulty administration of ReFacto AF, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs),or ongoing trauma responsible for continued bleeding."|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, “number of participants analyzed” signifies participants who were evaluable for this outcome measure and received treatment for at least one bleed.|||LETE bleeds|bleeding episodes||Number
2745323|NCT00914459|Secondary|Total Factor VIII Consumption: All Participants|Total factor VIII consumption for each participant was calculated by sum of the total amount of ReFacto AF (in IU) infused for each ReFacto AF infusion (recorded in the infusion log diary CRF). Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."|||IU||Standard Deviation|Mean
2745324|NCT00914459|Secondary|Average Infusion Dose of ReFacto AF: All Participants|The average infusion dose (by weight) for each participant was calculated as his total factor FVIII consumption (in IU) divided by weight (in kg) divided by the number of infusions administered in total study duration. Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."|||IU/kg||Standard Deviation|Mean
2745325|NCT00914459|Secondary|Number of Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of ReFacto AF: All Participants|"The number of breakthrough bleeds within 48 hours following a prophylaxis dose of ReFacto AF was summarized. The infusion log diary CRF was used to determine the number of infusions administered to treat a new bleed counting only those infusions which were administered <=48 hours after an infusion marked as prophylaxis (which had no associated bleed)."|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||breakthrough bleeds||Standard Deviation|Mean
2745326|NCT00914459|Secondary|Number of On-Demand ReFacto AF Infusions to Treat a New Bleed: All Participants|"The infusion log diary case report form (CRF) was used to determine the number of on-demand (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) ReFacto AF infusions administered to treat a new bleed. This was calculated by adding the initial for a new bleed (on-demand) infusion to any subsequent (on-demand) infusions for the same previously treated bleed (same bleed with same start date/time)."|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."|||infusions|bleeds|Standard Deviation|Mean
2745327|NCT00914459|Secondary|Response to First On-Demand Treatment for New Bleeds: All Participants|A 4-point scale of assessment of 'on-demand' treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: 1. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. 2. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode;or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following infusion, with no additional infusion administered. 3. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. 4. No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and received at least 1 dose of ReFacto AF for at least one bleeding episode."|||responses|bleeds||Number
2745328|NCT00914459|Secondary|Mean Annualized Bleeding Rates (ABRs): All Participants|ABR for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by the total therapy duration (in days), then multiplied by 365.25. ABR for the participants who reported following a primary or secondary prophylaxis, on-demand regimen or preventive regimen at baseline were reported.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at the specified time points."|||bleeds per year||Standard Deviation|Mean
2745329|NCT00914459|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||milliliter per hour per kilogram||Geometric Coefficient of Variation|Geometric Mean
2745344|NCT00914069|Secondary|Time Required to Obtain Access|A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.||||minutes||Standard Deviation|Mean
2745331|NCT00914459|Primary|Incremental Recovery|Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of ReFacto AF administered per kilogram of body weight. It was measured in international units per deciliter (IU/dL) per international units per kilogram (IU/kg).|Days 1, 15, 50, Months 6, 18 and Final visit (up to Month 24)|"The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable at the specified time point for each arm respectively."|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2745332|NCT00914459|Primary|Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development|Clinically significant factor VIII (FVIII) inhibitors were defined as a central laboratory confirmed positive inhibitor of greater than or equal to (>=) 0.6 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection: 1) the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, 2) >=2 events indicating a decrease in the efficacy of the study treatment. Percentage of participants who developed clinically significant Factor VIII inhibitor after study drug administration were reported.|Baseline up to Month 24|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||percentage of participants||95% Confidence Interval|Number
2745333|NCT00914316|Secondary|Percentage Increase in Absolute Walking Distance Following Phase 2|Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test|24 weeks|Missing data from one subject 24 week treadmill test in placebo/placebo group|||percentage of baeline||Inter-Quartile Range|Median
2745334|NCT00914316|Primary|Percentage Increase in Absolute Walking Distance Following Phase 1|Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test|12 weeks|Missing data for 12 week test in 1 subject in Ranolazine/Ranolazine group, 1 subject in Ranolazine/placebo group, and 3 subjects in placebo/placebo group|||percentage of baseline||Inter-Quartile Range|Median
2745335|NCT00914186|Primary|Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale|"Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from No Itch, even the slightest itch or Slight Itch, to Worst Itch Imaginable to denote the increase in severity of itching."|Baseline through Study Day 36 (Visit 7)||||participants|||Number
2745336|NCT00914186|Primary|Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.|Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.|Study Day -7 through Study Day 22|ITT|||units on a scale||Standard Deviation|Mean
2745337|NCT00914186|Primary|Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas|The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.|baseline through Study Day 36 (Visit 7)|ITT analysis|||units on a scale||Standard Deviation|Mean
2745338|NCT00914186|Primary|Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score|self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)|Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)|ITT|||units on a scale||95% Confidence Interval|Mean
2745339|NCT00914186|Primary|Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas|investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)|baseline through Study Day 36 (Visit 7)|ITT|||units on a scale||95% Confidence Interval|Mean
2745340|NCT00914186|Primary|Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events|Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms|Baseline through Study Day 36 (Visit 7)|total number of subjects who received study drug.|||participants|||Number
2745341|NCT00914186|Primary|Change in Pruritis Visual Analog Scale (VAS)|Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale|Baseline through Study Day 36 (Visit 7)|Intent To Treat (ITT) analysis|||mm||Standard Deviation|Mean
2745342|NCT00914069|Secondary|Summary of Minor Complications|Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.|Post-PIV placement until catheter removal (usually within 4 days)||||participants|||Number
2745343|NCT00914069|Secondary|Second Stick Success Rate|A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.|Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow Module because not all participants required a second attempt at catheter placement.|||participants|||Number
2745345|NCT00914069|Primary|Summary of Major Complications|Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.|Post-PIV placement until catheter removal (usually within 4 days)||||participants|||Number
2745346|NCT00914069|Primary|IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt|A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.||||participants|||Number
2745347|NCT00913978|Secondary|Post Operative Temperature on Admission to Post Operative Care Unit (PACU)|Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed.|Immediately after surgery|1 subject from the VITAheat group and 3 subjects from the Bair hugger group were excluded from analysis.|||Degrees Celcius||Full Range|Mean
2745348|NCT00913978|Primary|The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.|The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.|1 day||||percent time||Full Range|Mean
2745349|NCT00913913|Other Pre-specified|Clinical Response|clinical response by RECIST 1.1|Day 70||||participants|||Number
2745350|NCT00913913|Other Pre-specified|Measure of Percent of CD4 and CD8 Lymphocyte Subsets|percent of CD4 and CD8 positive lymphocyte subsets|Baseline, day 28, day 70|Peripheral blood lymphocyte subsets: 5 subjects at baseline and same 5 at day 70. 6 subjects analyzed at day 28|||percentage of total lymphocytes||Full Range|Mean
2745351|NCT00913913|Secondary|To Characterize the Number of Participants With Clinical and Autoimune Related Toxicity of Treatment|To characterize the clinical and autoimmune related toxicity profile of the combined treatment regimen using CTCAE 3. Toxicity reported are those expected from high dose IL-2 and were not considered adverse events.|5 years||||participants|||Number
2745352|NCT00913913|Primary|Progression Free Survival|median progression free survival|5 years||||DAYS||Full Range|Median
2745353|NCT00913835|Secondary|PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is >0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.|Randomization to PD or Date of Death (Up to 130 Weeks)|All participants who had evaluable PDGFRα results.|||weeks||95% Confidence Interval|Median
2745354|NCT00913835|Secondary|Apparent Volume of Distribution (Vss) of Olaratumab|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
2745355|NCT00913835|Secondary|Clearance (CL) of Olaratumab|CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
2745356|NCT00913835|Secondary|Half-life (t1/2) of Olaratumab|The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
2745357|NCT00913835|Secondary|Maximum Concentration (Cmax) of Olaratumab||Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
2745358|NCT00913835|Secondary|Area Under the Curve (AUC) of Olaratumab||Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
2745359|NCT00913835|Secondary|PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)|PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.|From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)|Participants who received Olaratumab treatment after PD on liposomal doxorubicin monotherapy. Participants censored=4|||weeks||90% Confidence Interval|Median
2747578|NCT00895232|Secondary|Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)|Quantifies amount of leg movement|Baseline to Day 84|Only subjects who recorded PLM's/Hour at Baseline AND on Day 84.|||PLM's per hour||Standard Deviation|Mean
2745360|NCT00913835|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline Up to 30-Day Postdose Follow-Up (Up To 35 Months)|All randomized participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.|||percentage of participants|||Number
2745361|NCT00913835|Secondary|Number of Participants With Adverse Events (AEs) and Who Died|Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.|Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)|All randomized participants who received any amount of study drug.|||participants|||Number
2745362|NCT00913835|Secondary|Median Duration of Response|Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.|Date of Initial CR or PR to PD (Up to 35 Months)|All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4.|||weeks||90% Confidence Interval|Median
2745363|NCT00913835|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) * 100.|Randomization to PD (Up to 35 Months)|mITT Population: All randomized participants who received any amount of study drug.|||percentage of participants||90% Confidence Interval|Number
2745364|NCT00913835|Secondary|Overall Survival (OS)|OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First Day of Therapy to Date of Death (Up to 35 Months)|mITT Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=21, Liposomal Doxorubicin=23.|||weeks||90% Confidence Interval|Median
2745365|NCT00913835|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.|Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)|Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.|||weeks||90% Confidence Interval|Median
2745366|NCT00913770|Secondary|Days of Self-reported Illicit Opioid Use in the Past 7 Days||30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104|||Mean Number of Days||95% Confidence Interval|Mean
2745367|NCT00913770|Primary|Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)|Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.|30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104|||Mean Number of Outpatient Visits||95% Confidence Interval|Mean
2745368|NCT00913744|Primary|Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28|The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation|Day 28|The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.|||percentage of subjects|||Number
2745369|NCT00913692|Secondary|Does Oral Glutamine Reduce the Area of Recurrent Lesions?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences, start and end dates of each recurrence and measurement of each lesion during each phase of the study would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||mm squared||Standard Deviation|Median
2745381|NCT00913627|Secondary|Time to Meaningful Pain Relief|Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant.|Baseline to 6 hours|ITT population|||minutes||95% Confidence Interval|Median
2745439|NCT00913380|Other Pre-specified|Radiation Dose|"Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The length indicates the scan range."|1 day after CT|All participants who underwent CT. Intention to treat. Complete case analysis.|||mGy•cm||Inter-Quartile Range|Median
2745370|NCT00913692|Secondary|Does Oral Glutamine Reduce the Duration of Recurrences?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||days||Standard Deviation|Median
2745371|NCT00913692|Secondary|Does Oral Glutamine Reduce the Time to First Recurrence of Herpes Labialis Diagnosed by Clinical and Microbiologic Criteria or Diagnosed by Clinical Criteria With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||days||Standard Deviation|Median
2745372|NCT00913692|Secondary|Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||herpes labialis lesions||Standard Deviation|Median
2745373|NCT00913692|Primary|Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of outbreaks would be measured during each phase.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.|||herpes labialis lesions|||Number
2745374|NCT00913627|Secondary|Peak Pain Relief Score|"Maximum PR score over the scheduled pain relief assessments. PR score based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief)."|Baseline to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2745375|NCT00913627|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Score|PRID=PID+PR, where PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline and could range from -1 to 3. Baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated improvement. PR: 5-point categorical pain relief scale (None [0], A Little [1], Some [2], A Lot [3], Complete [4]). PRID score could range from -1 to 7 where higher scores indicated better pain relief and decrease in pain intensity.|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours|ITT population.|||units on a scale||Standard Deviation|Mean
2745376|NCT00913627|Secondary|Pain Relief (PR) Score|"PR score based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None [0], A Little [1], Some [2], A Lot [3] or Complete [4]. Higher scores indicated improvement (better pain relief)."|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours|ITT population.|||units on a scale||Standard Deviation|Mean
2745377|NCT00913627|Secondary|Pain Intensity Difference (PID) Score|"PID based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). PID score derived by subtracting postdose score from baseline score and could range from -1 to 3. A baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated greater improvement (decrease in pain intensity)."|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours|ITT population.|||units on a scale||Standard Deviation|Mean
2745378|NCT00913627|Secondary|Participant Global Evaluation of Study Medication at 24 Hours|Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).|24 hours|ITT population; Number of participants analyzed (N)= participants with evaluable data|||participants|||Number
2745379|NCT00913627|Secondary|Participant Global Evaluation of Study Medication at 12 Hours|Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).|12 hours|ITT population|||participants|||Number
2745380|NCT00913627|Secondary|Percentage of Participants Achieving Meaningful Pain Relief|Participants evaluated the time to first perceptible pain relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief defined as relief from the pain that is considered meaningful to the participant.|15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes|ITT population|||percentage of participants|||Number
2745457|NCT00913003|Primary|24 Hour Hydromorphone|Total IV hydromorphone administered during surgery to 24 hours post surgery|24 hour||||miligrams||Standard Deviation|Mean
2745382|NCT00913627|Secondary|Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief|The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now.|15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes|ITT population|||percentage of participants|||Number
2745383|NCT00913627|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR)|"TOTPAR based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best)."|0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2745384|NCT00913627|Secondary|Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)|Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement.|0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
2745385|NCT00913627|Secondary|Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)|"Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity)."|0 to 4 hours and 4 to 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2745386|NCT00913627|Secondary|Percentage of Participants With Treatment Failure|Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy.|8, 9, 10, 11, and 12 hours|ITT population|||percentage of participants|||Number
2745387|NCT00913627|Secondary|Time to Treatment Failure|Time to first rescue medication or discontinuation due to lack of efficacy|Baseline to 24 hours|ITT population|||hours||95% Confidence Interval|Median
2745388|NCT00913627|Secondary|Time to First Perceptible Pain Relief|"Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled first perceptible relief, if the participant also depressed the second stopwatch labelled as meaningful relief by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently."|Baseline to 6 hours|ITT population|||minutes||95% Confidence Interval|Median
2745389|NCT00913627|Primary|Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)|"PID score based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity)."|8 to 12 hours post dose|ITT population|||units on a scale||Standard Deviation|Mean
2745390|NCT00913627|Primary|Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)|"Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity)."|Baseline (0 hour) to 12 hours post dose|Intent-To-Treat (ITT) population: randomized participants who dosed with study product and provided a baseline pain severity assessment.|||units on a scale||Standard Deviation|Mean
2745391|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
2745392|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
2745393|NCT00913523|Secondary|Abundance of Selected Microflora in Tampons|Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism.|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||CFU/gm||Standard Deviation|Mean
2745394|NCT00913523|Secondary|Percentage of Subjects With Selected Microflora in Tampons|Percentage of subjects with selected relevant microorganisms in tampons during menses|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
2745458|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Ileus||7 days||||Participants|||Number
2745395|NCT00913523|Secondary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
2745396|NCT00913523|Primary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
2745397|NCT00913510|Primary|Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.|Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%.|Baseline and 8 weeks after randomization.||||percent change||Standard Deviation|Mean
2745398|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2745399|NCT00913458|Secondary|WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
2745400|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2745401|NCT00913458|Secondary|WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||units on a scale||Standard Deviation|Mean
2745402|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2745420|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participant who took at least 1 dose of open-label investigational product|||participants|||Number
2745403|NCT00913458|Secondary|WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 Weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||units on a scale||Standard Deviation|Mean
2745404|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2745405|NCT00913458|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||units on a scale||Standard Deviation|Mean
2745406|NCT00913458|Secondary|Change From Baseline mTSS at Week 91 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)||||Units on a scale||Standard Error|Least Squares Mean
2745407|NCT00913458|Secondary|Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
2745408|NCT00913458|Secondary|Number of Participants Achieving Patient Acceptable Symptom State (PASS)|The PASS is defined as a symptom state that the subjects consider acceptable.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
2745409|NCT00913458|Secondary|Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)|100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||mm||Standard Deviation|Mean
2745410|NCT00913458|Secondary|Participant's Global Assessment of Disease Activity|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
2745411|NCT00913458|Secondary|Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
2745436|NCT00913380|Secondary|Visualization of the Normal Appendix|Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
2745459|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Nausea|Nausea at any time during the post operative period for 48 hours|Immediate post operative to 48 hours||||Participants|||Number
2745412|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 2 was defined as:~DAS28 <2.6 at the Week 76 and Week 91 visits and~No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.~Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder"|52 and 91 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
2745413|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
2745414|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
2745415|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
2745416|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
2745417|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
2745418|NCT00913458|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
2745419|NCT00913458|Secondary|Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit|The PASS is defined as a symptom state that the participants consider acceptable.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2770995|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2745421|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2745422|NCT00913458|Secondary|Change From Baseline in DAS44 Score at All Visits|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
2745423|NCT00913458|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
2745424|NCT00913458|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Units on a scale||Standard Deviation|Mean
2745425|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2745426|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2745427|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2745428|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2745437|NCT00913380|Secondary|Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.|"True positive: Perforation was rated as present in CT report and confirmed as present.~False positive: Perforation was rated as present in CT report and confirmed as absent.~True negative: Perforation was rated as absent in CT report and confirmed as absent.~False negative: Perforation was rated as absent in CT report and confirmed as present.~The data are used to calculate sensitivity and specificity."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
2747762|NCT00893971|Primary|Vital Sign Change From Baseline, SpO2|Vital Sign Change from baseline 12-hours post-dose SpO2 (%)|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter|||% blood oxygen saturation level||Full Range|Mean
2745429|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
2745430|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
2745431|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
2745432|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
2745433|NCT00913458|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Units on a scale||Standard Deviation|Mean
2745434|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 1 was defined as:~DAS28 <2.6 at the week 39 and 52 visits and,~No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,~Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits"|End of Phase 1|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
2745435|NCT00913458|Primary|Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score|"Sustained remission was defined as a DAS28 <2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 >3.2 at either the Week 56 or Week 64 visit.~DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity.~The participants who met sustained remission in both Week 76 and 91 are presented here."|76 and 91 weeks|Modified intent-to-treat (mITT) population, which included all participants who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
2745440|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.~Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
2745441|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.~Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
2745442|NCT00913380|Secondary|Interval From CT to Discharge After Appendectomy|Time interval between the CT acquisition and discharge after appendectomy|3 months after CT|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.|||day||Inter-Quartile Range|Median
2745443|NCT00913380|Secondary|Interval Between CT and Discharge Without Surgery|Time interval between the CT acquisition and discharge without surgery|3 months after CT|Participants who did not undergo surgery. Intention to treat. Complete case analysis.|||hr||Inter-Quartile Range|Median
2745444|NCT00913380|Secondary|Interval Between CT and Appendectomy|Time interval between the CT acquisition and non-incidental appendectomy|1 day after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.|||hr||Inter-Quartile Range|Median
2745445|NCT00913380|Secondary|Appendiceal Perforation|Number of participants with appendiceal perforation|1 week after surgery|Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.|||participants|||Number
2745446|NCT00913380|Secondary|Additional Imaging Test(s)|Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis|1 week after CT|All participants included in outcome analyses. Intention to treat. Complete case analysis.|||participants|||Number
2745447|NCT00913380|Primary|Negative Appendectomy|Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)|1 week after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.|||participants|||Number
2745448|NCT00913263|Secondary|Number of Days to Prostate Volume Nadir.|Number of Days from day of injection to prostate volume nadir.|Measured every 4th week until progression or maximum 6 months.||||Days||95% Confidence Interval|Median
2745449|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Final Visit|Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline|Measured every 4th week until progresion or maximum 6 months.||||percentage change||Standard Deviation|Median
2745450|NCT00913263|Secondary|Time to PSA Nadir|Time frame was from baseline to day of PSA nadir.|Measured every 4th week until progression or maximum 6 moths.||||Number of days from baseline to PSA nadi||95% Confidence Interval|Number
2745451|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Nadir.|Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.|Measured every 4th week until progression or maximum 6 months.||||percent change||Standard Deviation|Median
2745452|NCT00913263|Secondary|Number of Patients Reporting Adverse Events Caused by the Study Treatment|"Adverse events caused by the study treatment~Abnormal, clinically relevant, laboratory parameters~Voiding symptoms~Vital Signs~Quality of Life"|Measured every 4th week till progression or maximum 6 months|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, should be included in the efficacy analysis.~Study population safety All patients who received at least one dose of Liproca® Depot should be included in the safety analysis."|||Patients reporting study related AE|||Number
2745453|NCT00913263|Primary|Proportion of Patients Showing PSA Nadir|Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.|Measured every 4th week until progression or maximum 6 months.|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, were included in the efficacy analysis.~Study population safety All patients who received at least one dose of Liproca® Depot were included in the safety analysis."|||percentage of patients with PSA nadir||95% Confidence Interval|Number
2745454|NCT00913133|Secondary|Thrombosis|"New onset symptomatic thrombosis requiring medical or surgical intervention;~Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction."|Up until 24 hours after last dose of study drug|Patients who received at least one dose of study drug|||participants|||Number
2745455|NCT00913133|Primary|Major Bleeding|Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.|24 hours after last dose of study drug|All patients receiving at least one dose of study drug|||participants|||Number
2745456|NCT00913081|Primary|Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin|Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.|8 hour period|All subjects who finished at least one visit were analysed.|||Fold change over baseline||95% Confidence Interval|Mean
2745460|NCT00912964|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
2745461|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.|||participants|||Number
2745462|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.|||participants|||Number
2745463|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale|The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.|||participants|||Number
2745464|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
2745465|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Error|Least Squares Mean
2745466|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Error|Least Squares Mean
2745467|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Deviation|Mean
2745468|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2745469|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2745470|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2745471|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2745472|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2745473|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percent activity impairment||Standard Deviation|Mean
2745474|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent overall work impairment||Standard Deviation|Mean
2745515|NCT00912743|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months|Full analysis set - all treated patients|||days||95% Confidence Interval|Median
2745475|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent impairment while working||Standard Deviation|Mean
2745476|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent work time missed||Standard Deviation|Mean
2745477|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||scores on a scale||Standard Error|Least Squares Mean
2745478|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||scores on a scale||Standard Error|Least Squares Mean
2745479|NCT00912964|Secondary|Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes|Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||percentage of participants|||Number
2745480|NCT00912964|Secondary|Percentage of Responders for Mean Level of Urgency|Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence).|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||percentage of participants|||Number
2745481|NCT00912964|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
2745482|NCT00912964|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
2745483|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||pads||Standard Error|Least Squares Mean
2745484|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||nocturia episodes||Standard Error|Least Squares Mean
2745485|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency|Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized for this analysis. The number of participants included in the calculation for each time point is noted as N."|||scores on a scale||Standard Error|Least Squares Mean
2745486|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was not utilized for this analysis. N is the number of patients included at each time point.|||Urgency episodes||Standard Error|Least Squares Mean
2745487|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode (grade 3 or 4) at baseline. LOCF was not utilized.|||Urgency incontinence episodes||Standard Error|Least Squares Mean
2745488|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N."|||mL||Standard Error|Least Squares Mean
2745489|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
2745516|NCT00912743|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients|||days||95% Confidence Interval|Median
2747763|NCT00893971|Primary|Vital Sign Change Baseline; Blood Pressure|Vital sign change baseline; blood pressure|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter|||mmHg||Full Range|Mean
2745490|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.|||micturitions||Standard Error|Least Squares Mean
2745491|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. Last observation carried forward was utilized.|||urgency episodes||Standard Error|Least Squares Mean
2745492|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2745493|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency|Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||scores on a scale||Standard Error|Least Squares Mean
2745494|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.|||micturitions||Standard Error|Least Squares Mean
2745495|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was not utilized in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
2745496|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||micturitions||Standard Error|Least Squares Mean
2745497|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||mL||Standard Error|Least Squares Mean
2770996|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2745498|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
2745499|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Levels|Urinary Glycosaminoglycan (GAG) Levels: Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 26||||ug/mg||Standard Deviation|Mean
2745500|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one's arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week 26||||Degrees||Standard Deviation|Mean
2745501|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ) = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to week 26||||Units on a scale||Standard Deviation|Mean
2745502|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 26||||Cubic centimeters||Standard Deviation|Mean
2745503|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. Overall change from Baseline to Week 26 in AHI. A greater decrease in events indicates a greater response.|Baseline to Week 26||||Events per hour||Standard Deviation|Mean
2745504|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test (6MWT): Distance walked (measured in meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 26||||meters||Standard Deviation|Mean
2745505|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity (FVC): the maximal exhaled breathe volume following a maximal inhaled breath. Overall Change from Baseline to Week 26 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 26||||Percent predicted FVC||Standard Deviation|Mean
2745506|NCT00912912|Primary|12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate|Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.|12 weeks||||Percentage of Participants|||Number
2745507|NCT00912808|Secondary|Frequency of Near Falls Per Day|The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.|6 weeks||||Number Near Falls/Day||Standard Error|Mean
2745508|NCT00912808|Primary|Fall Frequency Per Day|The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.|6 weeks||||Number Falls/Day||Standard Error|Mean
2745509|NCT00912795|Secondary|Self-reported 30-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
2745510|NCT00912795|Secondary|Self-reported 7-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
2745511|NCT00912795|Secondary|CO-verified 7-day Point Prevalence Abstinence at 4 Weeks|self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|4 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
2745512|NCT00912795|Primary|Carbon Monoxide-verified Continuous Abstinence at 12 Weeks|self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|12-weeks post-quit day|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
2745513|NCT00912782|Secondary|25-hydroxyvitamin D and Serum Calcium||10 weeks||||ng/mL||Standard Deviation|Mean
2745514|NCT00912782|Primary|Arteriovenous Fistulae Maturation|Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow >300 ml/min, assessed at six months following AVF creation.|6 months||||percentage of group|||Number
2745517|NCT00912743|Primary|Tumour Response|Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients|||Percentage of Participants||95% Confidence Interval|Number
2745518|NCT00912509|Secondary|Time to Resolution of Stromal Infiltration||day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved||||days||Inter-Quartile Range|Median
2745519|NCT00912509|Primary|Time to Re-epithelialization||Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete||||Days||Inter-Quartile Range|Median
2745520|NCT00912405|Secondary|Number of Sinuses With Significant Post-operative Adhesion Formation|Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.|30 days||||sinuses|Participants||Number
2745521|NCT00912405|Secondary|Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities|Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.|Baseline and 30 days||||Pts. w/ significant IOP elevation|||Number
2745522|NCT00912405|Primary|Device Placement Success Rate|A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.|At the time of procedure||||Sinuses|Participants||Number
2745523|NCT00912405|Primary|Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)||30 days||||Number of Sinuses|Participants|95% Confidence Interval|Number
2745524|NCT00912340|Secondary|Progression-free Survival (PFS) in Patients Who Crossed Over|Median PFS will be calculated based on time to first progression or death.|Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years|"Among 48 patients with disease progression, everolimus was added to 16 patients treated by trastuzumab, and trastuzumab was added to 12 patients treated by everolimus.~Four patients were treated with both trastuzumab & everolimus up front. These patients were not included in the data analysis because this arm was later discontinued."|||months||95% Confidence Interval|Median
2745525|NCT00912340|Primary|Progression-free Survival (PFS) Until First Progression|Median PFS will be calculated based on time to first progression or death.|Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years|Four patients were treated with both trastuzumab & everolimus up front. These patients were not included in the data analysis because this arm was later discontinued.|||months||95% Confidence Interval|Median
2745526|NCT00912301|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|after 4 days' treatment||||percentage of the radio-labeled meal||Standard Deviation|Mean
2745527|NCT00912301|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|after 4 days' treatment||||units on a scale||Standard Deviation|Mean
2745528|NCT00912301|Secondary|Ascending Colon Emptying (AC t_1/2)||after 4 days' treatment||||hours||Standard Deviation|Mean
2745529|NCT00912301|Secondary|Colonic Transit at 48 Hours (GC48)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment||||units on a scale||Standard Deviation|Mean
2745530|NCT00912301|Primary|Colonic Geometric Center at 24 Hours (GC24)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment||||units on a scale||Standard Deviation|Mean
2745531|NCT00912288|Secondary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence (including clinially important changes in clinical safety laboratory assessments, electrocardiograms and vital signs) in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study medication, including partial doses.|||Participants|||Number
2745532|NCT00912288|Secondary|Population Pharmacokinetic (PK) Analysis|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12|||||||
2745533|NCT00912288|Secondary|Euro Quality of Life - 5 Domain (EQ-5D) Assessment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Total possible score ranged from 5 to 15; lower score indicated a better health state.|Baseline, Weeks 12, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745605|NCT00911859|Secondary|1-year Survival Rate|Percentage of participants who are alive at the end of year 1 after randomization|1 year|Intent-to-treat (ITT) population: all randomized participants|||Percentage of participants|||Number
2745534|NCT00912288|Secondary|Resource Utilization in Dementia-Lite Version (RUD-Lite)|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver's job. Overall cost of care was evaluated to quantify resources utilized.|Baseline, Weeks 12, 18, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745535|NCT00912288|Secondary|Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores|Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) version of CIBIC-Plus was used to assess participant's overall disease severity. The corresponding baseline assessment rated participant on 7-point scale: (1) extremely severe AD to (7) no symptoms of AD. Overall impression of change from baseline was rated on a 7-point scale: 1=marked improvement; 2=moderate improvement; 3=minimal improvement; 4=no change; 5=minimal worsening; 6=moderate worsening; 7=marked worsening; all assessments are relative to baseline. Higher score = worsening of global function.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745536|NCT00912288|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745537|NCT00912288|Secondary|Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer's Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745538|NCT00912288|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745539|NCT00912288|Primary|Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745540|NCT00912288|Primary|Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis(0-8), visuospatial ability(0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score = greater cognitive impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
2745541|NCT00912223|Secondary|Serum Rituximab (RTX) Levels|RTX concentration levels within participants|Baseline, Days 28 and 365|Serum RTX concentrations were collected at baseline (n=57), day +28 (n=56), and day +365 (n=44) for a compliance rate of 92%, 90%, and 80% at the assigned time points.|||ng/mL||Full Range|Median
2745542|NCT00912223|Secondary|Incidence of Toxicities|Number of participants that experiences at least one grade 3 - 5 toxicity during the first two years, where grade 5 is worst. Toxicity grades are based on the NCI CTCAE Version 3.0.|Year 2||||participants|||Number
2745543|NCT00912223|Secondary|Immunologic Reconstitution|Quantitative immunoglobulins (IgG)|Year 1||||mg/dL||Full Range|Median
2745544|NCT00912223|Secondary|Quality of Life||Year 2|No data collected||||||
2745545|NCT00912223|Secondary|Infections||Year 2|no data collected||||||
2745546|NCT00912223|Secondary|Treatment-related Mortality (TRM)|The event is death occurring in patients in continuous complete remission. The TRM distribution will be estimated by the Kaplan-Meier curve.|Year 3||||percentage of participants||95% Confidence Interval|Number
2745547|NCT00912223|Secondary|Overall Survival|The event is death from any cause.|Years 2 and 3||||percentage of participants||95% Confidence Interval|Number
2747764|NCT00893971|Primary|Heart Rate Change From Baseline|Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter|||bpm||Full Range|Mean
2745548|NCT00912223|Secondary|Chronic GVHD|The event is the incidence and severity of chronic GVHD from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval at two years post-transplant. Death prior to occurrence of chronic GVHD will be considered as a competing risk.|Year 2||||percentage of participants||95% Confidence Interval|Number
2745549|NCT00912223|Secondary|Acute Graft-versus-Host Disease (GVHD)|The event is the incidence of grades II-IV acute GVHD from day of transplant, where grade IV is worst. The first day of acute GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that acute GVHD grade. GVHD should be monitored in accordance with BMT CTN manual of procedures guidelines. Acute GVHD grading was based on the consensus conference criteria (Przepiorka, et. al., 1994) and the Center for International Blood and Marrow Transplant Research (CIBMTR) grading criteria.|Day 100||||percentage of participants||95% Confidence Interval|Number
2745550|NCT00912223|Secondary|Time to Neutrophil Recovery|Neutrophil Recovery is defined as ANC > 500/mm^3 for 3 consecutive days.|Day 60||||days||Full Range|Median
2745551|NCT00912223|Secondary|Donor Cell Engraftment|Donor engraftment is defined as > 5% donor peripheral blood T cell chimerism by Day +30 post-transplant in the setting of Absolute Neutrophil Count (ANC) recovery (ANC >500/mm^3 for 3 consecutive days).|Days 30 and 100||||percentage of donor T-cell chimerism||Full Range|Median
2745552|NCT00912223|Secondary|Graft Failure|Primary graft failure is defined as a donor peripheral blood T cell chimerism < 5% at Day +30 post-transplant. Secondary Graft Failure is defined as documented engraftment followed by loss of graft as defined by donor peripheral blood T cell chimerism < 5%.|Day 30||||participants|||Number
2745553|NCT00912223|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die, or if they relapse/progress or receive anti-lymphoma therapy not including planned post-transplant radiation.|Year 2||||percentage of participants||95% Confidence Interval|Number
2745554|NCT00912158|Primary|Number of Patients Who Were Intubated|Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation|During ICU Stay||||participants|||Number
2745555|NCT00912158|Secondary|Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality||Hospital stay||2010-01-31|01/2010||||
2745556|NCT00912093|Secondary|Time to Investigator-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
2745557|NCT00912093|Secondary|Time to Subject-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
2745558|NCT00912093|Secondary|Time to Almost Complete Symptom Relief|Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores <10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.|Up to 120 Hours post treatment|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
2745559|NCT00912093|Secondary|Time to Onset of Primary Symptom Relief|Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
2745560|NCT00912093|Primary|Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient|Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
2745561|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
2745562|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
2745563|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those who are enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
2745564|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks||||eyes|eyes||Number
2745565|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.|||eyes|eyes||Number
2745566|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis is on those subjects who were enrolled, randomized, and completed the study.|||eyes|eyes||Number
2745567|NCT00912015|Primary|Adverse Events: 12-months Safety Population|Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.|12 months|Patients who received the same dose for at least 350 days (12 months)|||participants|||Number
2745568|NCT00912002|Secondary|Number of Participants Who Discontinued the Study Due to An Adverse Event||Up to 14 days after study drug administration|All treated participants.|||participants|||Number
2745569|NCT00912002|Secondary|Number of Participants Who Experienced An Adverse Event||Up to 14 days after study drug administration|All treated participants.|||participants|||Number
2745570|NCT00912002|Primary|Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).|Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.|Up to 168 hours after study drug administration|All treated participants.|||Percent Recovered||Standard Deviation|Mean
2745571|NCT00911989|Primary|Proportion of Procedures Completed With Successful Endoscopic Visualization.|The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.|Assessed intra-operatively|All subjects on whom the surgery was attempted represent the primary analysis population.|||participants|||Number
2745572|NCT00911937|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2745573|NCT00911937|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2745574|NCT00911937|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Least Squares Mean
2745607|NCT00911859|Secondary|1-year Progression-Free Survival (PFS) Rate|The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.|1 year|Intent-to-treat (ITT) population: all randomized participants|||Percentage of participants|||Number
2745575|NCT00911937|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2745576|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||mL||Standard Error|Least Squares Mean
2745577|NCT00911937|Secondary|Mean Voided Volume Per Micturition|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||mL||Standard Deviation|Mean
2745578|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||mL||Standard Error|Least Squares Mean
2745579|NCT00911937|Secondary|Mean Voided Volume Per Nocturnal Micturition|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||milliliter (mL)||Standard Deviation|Mean
2745580|NCT00911937|Secondary|Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Least Squares Mean
2745581|NCT00911937|Secondary|Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2745582|NCT00911937|Secondary|Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
2745583|NCT00911937|Secondary|Nocturnal Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
2745584|NCT00911937|Secondary|Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2745608|NCT00911859|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.|From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
2770997|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2745585|NCT00911937|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
2745586|NCT00911937|Secondary|Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
2745587|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2745588|NCT00911937|Secondary|Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
2745589|NCT00911937|Secondary|Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
2745590|NCT00911937|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2745591|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Error|Least Squares Mean
2745592|NCT00911937|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Deviation|Mean
2745593|NCT00911937|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2745606|NCT00911859|Secondary|Duration of Response (DOR)|DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.|From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication|Included participants in the randomized population who achieved CR or PR.|||Days||95% Confidence Interval|Median
2745594|NCT00911937|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Error|Least Squares Mean
2745595|NCT00911937|Secondary|Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Deviation|Mean
2745596|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
2745597|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.|||episodes per 24 hours||Standard Error|Least Squares Mean
2745598|NCT00911937|Primary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
2745599|NCT00911937|Primary|Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours|Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|Full analysis set (FAS): all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’(number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
2745600|NCT00911898|Primary|Maximum Tolerated Dose (MTD) or Maximum Feasible Dose|The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.|28 days||||mg/kg|||Number
2745601|NCT00911898|Secondary|To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity||December 2011|||||||
2745602|NCT00911898|Secondary|To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)||December 2011|||||||
2745603|NCT00911859|Secondary|Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)|"Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) health and quality of life."|Baseline (Day 1 predose) and Cycle 9 (Week 54)|Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9|||Scores on a scale||Standard Deviation|Mean
2745604|NCT00911859|Secondary|Overall Survival|Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.|From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
2745609|NCT00911859|Secondary|Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria|sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.|||Percentage of participants|||Number
2745610|NCT00911859|Secondary|Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.|||Percentage of participants|||Number
2745611|NCT00911859|Primary|Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.|||Percentage of participants|||Number
2745612|NCT00911820|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2745613|NCT00911820|Secondary|Overall Response (OR) Rate|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
2745614|NCT00911820|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2745615|NCT00911820|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.|Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2745716|NCT00911144|Primary|Number of Subjects Reporting Grade 3 Adverse Events|Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.|Within 31 days (Day 0 - Day 30) after booster vaccination.|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||Participants|||Count of Participants
2745616|NCT00911820|Primary|7-month Progression-Free Survival|7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
2745617|NCT00911807|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry , Urinalysis, Electrocardiogram [ECG])||Baseline, week 4, 12, 16, 28|||||||
2745618|NCT00911807|Secondary|Combined Responders, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 28|||||||
2745619|NCT00911807|Secondary|Change From Baseline in Total Score for Neuropsychiatric Inventory (NPI)||week 16, 28|||||||
2745620|NCT00911807|Secondary|Change From Baseline for Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)||week 16, 28|||||||
2745621|NCT00911807|Secondary|Clinical Interview-based Impression of Severity (CIBIS+) Score||week 28|||||||
2745622|NCT00911807|Secondary|CIBIC+ Responders||week 4, 12, 16, 28|||||||
2745623|NCT00911807|Secondary|CIBIC+ Score||week 4, 12, 16|||||||
2745624|NCT00911807|Secondary|Change From Baseline for Original ADAS-COG||week 4, 12, 16, 28|||||||
2745625|NCT00911807|Secondary|ADAS-COG+ Responders||week 4, 12, 16, 28|||||||
2745626|NCT00911807|Secondary|Change From Baseline for ADAS-COG+||week 4, 12, 16|||||||
2745627|NCT00911807|Primary|Clinical Interview-based Impression of Change (CIBIC+) Score||week 28|||||||
2745628|NCT00911807|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28|The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.|baseline and week 28|Analysis was intention to treat|||points on a scale||Standard Deviation|Mean
2745629|NCT00911768|Secondary|Unstimulated Salivary Flow Rates|Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.|||ml/min||Standard Deviation|Mean
2745630|NCT00911768|Secondary|Stimulated Salivary Flow Rates|Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.|||ml/min||Standard Deviation|Mean
2745631|NCT00911768|Primary|Visual Analogue Scale of Subjective Dry Mouth|Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.|8 weeks|Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.|||cm||Standard Deviation|Mean
2745632|NCT00911742|Secondary|Tmax|Time to maximum plasma concentration|48 hours||||hours||Full Range|Median
2745633|NCT00911742|Secondary|t1/2|Apparent terminal elimination half-life|48 hours||||hours||Standard Deviation|Mean
2745634|NCT00911742|Primary|Cmax|Maximum plasma concentration|48 hours||||ng/mL||Standard Deviation|Mean
2745635|NCT00911742|Primary|AUC (0-∞)|"The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL.~h=hours"|48 hours||||ng.h/mL||Standard Deviation|Mean
2745636|NCT00911742|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measured concentration.~h=hour"|48 hours||||ng.h/mL||Standard Deviation|Mean
2745637|NCT00911625|Secondary|The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter|At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts|6 Days|This analysis comprises all participants who were randomized and completed all study activities|||Participants|||Count of Participants
2745638|NCT00911625|Primary|Average Blood Glucose Over 6 Days|Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts.|6 Days|The analysis population for the primary outcome comprises all participants who were randomized and completed all study activities|||milligrams per deciliter||Standard Deviation|Mean
2745639|NCT00911612|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|After 12-14 days' treatment||||units on a scale||Standard Error|Mean
2745640|NCT00911612|Secondary|Colonic Transit, Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days' treatment||||units on a scale||Standard Error|Mean
2745717|NCT00911053|Secondary|Treatment Effects on Sleep and Alertness Will be Assessed by Daily Diaries and Daily Wrist Actigraphic Monitoring. Subjective Benefits Will be Assessed With Daily Ratings of Alertness and Vigor.||1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2745641|NCT00911612|Secondary|Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours|Colonic permeability is measured through differential excretion of urine saccharides. The subject ingests a methacrylate-coated capsule that contains saccharides (mannitol 1g and lactulose 5 g powder). The capsule provides a means to protect the sugars from absorption, until the sugars are delivered to the colon by means of a standard delayed release capsule. The value reported is the mean for each arm of the total amount of mannitol excreted over the 8-24 hour time period.|after 12-14 days' treatment||||mg||Standard Error|Mean
2745642|NCT00911612|Primary|Ascending Colon Emptying T1/2|The half time for the ascending colon emptying (T1/2) was measured by the scintigraphic method. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule that is swallowed by the subject. Anterior and posterior gamma images are taken hourly. From the hourly scans, a time-activity curve is plotted using linear interpolation between time points when content was measured. The time taken to empty 50% of the isotope from the ascending colon is read from this time-activity curve.|After 12-14 days' treatment||||hours||Standard Error|Mean
2745643|NCT00911612|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days treatment||||units on a scale||Standard Error|Mean
2745644|NCT00911547|Secondary|Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only|"Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake all night), were assigned numerical values (0, 1, 2, 3, respectively).~The average score for the visit was determined by averaging the daily scores over all days between consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2745645|NCT00911547|Secondary|Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma|Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Liters/minute||95% Confidence Interval|Least Squares Mean
2745646|NCT00911547|Secondary|Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use|Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2745647|NCT00911547|Primary|Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma|"The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.~The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2745648|NCT00911547|Primary|Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma|Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups|Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means|||Percentage of Change||95% Confidence Interval|Least Squares Mean
2745649|NCT00911534|Other Pre-specified|Time to Achieve First 24-Hour Period Without Heartburn|Participants completed a daily symptom diary.|Baseline to Week 4|ITT|||Days||Standard Error|Mean
2745650|NCT00911534|Other Pre-specified|Percentage of Participants With Complete Heartburn Relief|Participants completed a daily symptom diary.|Week 2 and Week 4|ITT (n=number of participants with evaluable data)|||Percentage of Participants|||Number
2745651|NCT00911534|Primary|Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4|Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.|Week 4|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug (n=number of participants with evaluable data)|||Percentage of Days||Standard Deviation|Mean
2745652|NCT00911534|Secondary|Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4|Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.|Baseline and Week 4|ITT|||Scores on a Scale||Standard Deviation|Mean
2745653|NCT00911508|Secondary|Number of Participants With Adverse Events/Complications|"Comparing individual non-endpoint adverse events between ablative and drug therapy is difficult due to the substantial difference in the types of adverse events expected.~Ablation-related events were counted among all patients that were randomized to and received an ablation.~Drug-related events were counted among all patients that were randomized to and received drug therapy."|From treatment start date to date of event over a median follow-up of 48.5 months.|"Ablation-related events were counted among all patients that were randomized to and received an ablation.~Drug-related events were counted among all patients that were randomized to and received drug therapy."|||Participants|||Count of Participants
2745654|NCT00911508|Secondary|Changes in Quality of Life Measures - MAFSI Severity Score|The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI severity scores over the past month were recorded as 1 (mild), 2 (moderate), and 3 (extreme) for each of the 10 items listed in the questionnaire. The 10 items items were then summed for the total Severity Score that ranged from 0 (no AF symptoms) to 30 (most severe AF symptoms).|Baseline, 12 Month, 5 Year|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2745655|NCT00911508|Secondary|Changes in Quality of Life Measures - MAFSI Frequency Score|The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI frequency of symptoms over the past month was recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), and 4 (always) for each of the 10 items listed in the questionnaire. The 10 item responses were summed for a total Frequency Score that ranged from 0 (no AF symptoms) to 40 (worst score).|Baseline, 12 Month, 5 Year|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2745656|NCT00911508|Secondary|Changes in Quality of Life Measures - AFEQT|Atrial Fibrillation Effect on Quality of Life (AFEQT) Overall Score (Scale: 0 = complete disability, 100 = no disability). The AFEQT is a 21-item AF-specific, health-related QOL questionnaire designed to assess the effect of atrial fibrillation on patient quality of life. The AFEQT has an Overall Score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. Overall and subscale scores range from 0 (corresponds to complete disability) to 100 (no AF-related disability).|Baseline ,12 month, 5 years|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2745657|NCT00911508|Secondary|Number of Participants With Cardiovascular Hospitalization|The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.|From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745658|NCT00911508|Secondary|Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period|Data from patients using the study provided ECG event recording system were analyzed. A 30-second episode of AF in either group, confirmed through blinded review by an ECG Core Lab Committee was used for defining the endpoint of recurrent AF.|From date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months.|Subjects were analyzed in the post-blanking period if randomized treatment occurred and the subject did not die, withdraw, or get lost to follow-up before the end of the 90 day blanking period.|||Participants|||Count of Participants
2745659|NCT00911508|Secondary|Number of Participants With Heart Failure Death|All deaths were categorized and adjudicated by the Clinical Events Committee|From date of enrollment until date of heart failure death over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745660|NCT00911508|Secondary|Number of Participants With an Arrhythmic Death or Cardiac Arrest|All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee|From date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745661|NCT00911508|Secondary|Number of Participants With Cardiovascular Death or Disabling Stroke|Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2.|From date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745662|NCT00911508|Secondary|Number of Participants With Cardiovascular Death|Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator|From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745663|NCT00911508|Secondary|Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events)|Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2 and the reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.|From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745664|NCT00911508|Secondary|Number of Participants With Mortality or Cardiovascular (CV) Hospitalization|Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.|From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745665|NCT00911508|Secondary|Number of Participants With All-cause Mortality|All deaths were reviewed and adjudicated by the Clinical Events Committee|From date of enrollment until date of death over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745666|NCT00911508|Primary|Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.|All events for each component of the primary endpoint were reviewed and adjudicated in a blinded fashion by an independent clinical events committee using prospectively determined event definitions. Death was defined as all-cause mortality, disabling stroke (including intracranial bleeding) as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2, and serious bleeding as bleeding accompanied by hemodynamic compromise that required surgical intervention or a transfusion of ≥3 units of blood.|From date of enrollment until time-to-first event over a median follow-up of 48.5 months.||||Participants|||Count of Participants
2745667|NCT00911495|Secondary|Volume of the Peripheral Compartment||48 hours||||mL/kg||Standard Deviation|Mean
2745668|NCT00911495|Secondary|Intercompartmental Clearance||48 hours||||mL/h/kg||Standard Deviation|Mean
2745669|NCT00911495|Secondary|Volume of the Central Compartment||48 hours||||mL/kg||Standard Deviation|Mean
2745670|NCT00911495|Other Pre-specified|Blood Flow and Biomarkers of Adhesion|As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity.|48 hours|||||||
2745671|NCT00911495|Secondary|Total Plasma Clearance||48 hours|All subjects were analyzed for pharmacokinetics; one subject of the 15 enrolled was lost to follow-up.|||mL/h/kg||Standard Deviation|Mean
2745672|NCT00911495|Primary|Safety as Measured by the Number of Participants With Adverse Events||28 days|All enrolled subjects were analyzed for safety.|||participants|||Number
2745673|NCT00911443|Primary|Overall Tumor Response|Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response|1 year||||participants|||Number
2745674|NCT00911443|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from the randomization to progression or death|2 years||||months||95% Confidence Interval|Median
2745675|NCT00911443|Secondary|Overall Survival|The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored.|2 years||||months||95% Confidence Interval|Median
2745676|NCT00911326|Secondary|Lymph Node Detection Rate|The rate of the subjects for whom Lymphoseek identified at least 1 sentinel lymph node. The detection rate point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek||||percentage of participants||95% Confidence Interval|Number
2745677|NCT00911326|Secondary|Overall Accuracy|The overall accuracy is calculated as a percentage from the ratio of (true positives + true negatives) / (true positives + false negatives + true negatives). The overall accuracy point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek||||percentage of participants||95% Confidence Interval|Number
2745678|NCT00911326|Secondary|Negative Predictive Value (NPV)|The NPV is calculated as a percentage from the ratio of true negatives to the sum of true negatives plus false negatives. The NPV point estimate was the observed rate and was made on a per-patient basis relative to patients predicted to be pathology-negative.|Surgery after injection of Lymphoseek||||% of participants predicted negative||95% Confidence Interval|Number
2745679|NCT00911326|Primary|False Negative Rate (FNR)|The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.|Surgery after injection of Lymphoseek||||% of pathology-positive participants||95% Confidence Interval|Number
2745680|NCT00911300|Secondary|Number of Participants Who Were Re-hospitalized|Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745681|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm|Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745682|NCT00911300|Secondary|Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE|Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF.|At second TEE (at Day 28+/-4)|mITT Population. Only clot-positive participants at the time of the first TEE were analyzed.|||participants|||Number
2745683|NCT00911300|Secondary|Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm|CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed.|Day 1 until Day 3|mITT Population. Only participants with data for primary successful electric cardioversion at the indicated timepoint were analyzed.|||participants|||Number
2745718|NCT00911053|Primary|Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.||1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2770998|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2745684|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745685|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event|Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745686|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause|The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745687|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism|Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745688|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
2745689|NCT00911300|Primary|Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants|Modified Intent-to-Treat (mITT) Population: all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available|||participants|||Number
2745690|NCT00911274|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
2745691|NCT00911274|Primary|AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
2745692|NCT00911274|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
2745702|NCT00911157|Secondary|Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).|Safety Population: all participants who received at least one dose of medication (FPX or UFH).|||percentage of participants|||Number
2745693|NCT00911170|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that - is fatal; - is life threatening (places the participant at immediate risk of death); - requires inpatient hospitalization or prolongation of existing hospitalization; - results in persistent or significant disability/incapacity; - is a congenital anomaly/birth defect; - other significant medical hazard. AEs were assessed for severity according to National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 3.0, based on this general guideline: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.|Approximately 8 weeks (4 treatment cycles)|Safety analysis set, defined as all participants in the Primary Analysis Set who received at least one dose of investigational product (IP; placebo or pegfilgrastim). One participant was randomized to the placebo arm but actually received pegfilgrastim and is included in the pegfilgrastim arm for the safety analyses.|||participants|||Number
2745694|NCT00911170|Secondary|Percentage of Participants With Grade 4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2745695|NCT00911170|Secondary|Percentage of Participants With Grade 3/4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <1.0 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2745696|NCT00911170|Secondary|Percentage of Participants With Grade 4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|"Grade 4 febrile neutropenia (FN) is defined as:~A temperature ≥ 38.0ºC (≥ 100.4ºF) and absolute neutrophil count (ANC) < 0.5 × 10^9/L, where ANC is measured the same day or within +/- 1 calendar day of a temperature ≥ 38.0ºC (≥ 100.4ºF), or~An ANC <0.5 × 10^9/L in combination with:~Documented sepsis or infection, OR~Neutropenia-related hospitalization where ANC is measured the same day or within +/- 1 calendar day."|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2745697|NCT00911170|Secondary|Percentage of Participants With an Objective Response|The percentage of participants with a complete response (CR) or partial response (PR) defined by the RECIST v1.1 criteria at any time during the study. Response was be determined by the investigator's assessment of radiographic scans. CR: Disappearance of all non-nodal target lesions and the disappearance of all non-nodal non-target lesions, and no new lesions. All nodal lesions must have reduction of short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters and no new lesions and/or unequivocal progression of existing non-target lesions, or, the disappearance of all non-nodal target lesions with persistence of one or more non-target lesion(s).|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set participants with measurable disease at Baseline.|||percentage of participants||95% Confidence Interval|Number
2745698|NCT00911170|Secondary|Time to Progression|Time from randomization to date of radiological disease progression calculated using the Kaplan-Meier method. Participants without progression were censored on the date of their last radiographic tumor assessment. Disease progression based on the investigator's assessment of scans using the RECIST v1.1. Clinical progression without radiological assessment was not considered a disease progression. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set|||months||95% Confidence Interval|Median
2745699|NCT00911170|Secondary|Progression Free Survival|Time from randomization to date of radiological disease progression or death from any cause, whichever event occurs first, calculated using the Kaplan-Meier method. Participants without either event by the analysis data cutoff date were censored on the date of their last evaluable disease assessment. Disease progression based on the investigator's assessment of radiographic scans using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Clinical progression without radiological assessment was not be considered a disease progression in this analysis. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set|||months||95% Confidence Interval|Median
2745700|NCT00911170|Secondary|Overall Survival|Median time from randomization to date of death caclulated using the Kaplan-Meier method. Participants were censored on the date of last contact (i.e., the date the participant was last known to be alive) if they were not known to have died.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set|||months||95% Confidence Interval|Median
2745701|NCT00911170|Primary|Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) < 1.0 × 10^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC < 1.0 × 10^9/L in combination with: - documented sepsis or infection, OR - neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|The primary analysis set which included all participants with a signed informed consent, and who were randomized and received at least 1 dose of protocol-specified study treatment (chemotherapy, bevacizumab, or investigational product).|||percentage of participants||95% Confidence Interval|Number
2747867|NCT00892697|Secondary|Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir|Intrahepatic and plasma telaprevir concentration ratios|Day 1, Day 4, Day 15, Week 8||||telaprevir liver to plasma conc ratio||Inter-Quartile Range|Median
2745703|NCT00911157|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10|Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS|||points on a scale||Standard Deviation|Mean
2745704|NCT00911157|Secondary|Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline|"Classifications of Improved, No change, or Worse were adjudicated blindly by the CIACE."|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS|||percentage of participants|||Number
2745705|NCT00911157|Secondary|Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE.|From Day 1 to Day 90 (±7 days)|FAS|||percentage of participants|||Number
2745706|NCT00911157|Primary|Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute symptomatic deep vein thrombosis (DVT)|||percentage of participants|||Number
2745707|NCT00911144|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)|Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||ug/mL||95% Confidence Interval|Geometric Mean
2745708|NCT00911144|Secondary|Concentration of Antibodies Against Protein D (PD)|Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
2745709|NCT00911144|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||titer||95% Confidence Interval|Geometric Mean
2745710|NCT00911144|Secondary|Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||ug/mL||95% Confidence Interval|Geometric Mean
2745711|NCT00911144|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.~Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||titer||95% Confidence Interval|Geometric Mean
2745712|NCT00911144|Secondary|Concentration of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL).~Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||ug/mL||95% Confidence Interval|Geometric Mean
2745713|NCT00911144|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After booster vaccination up to study end (Month 0 to Month 1)||||Participants|||Count of Participants
2745714|NCT00911144|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|Within 31 days (Days 0 to 30) after booster vaccination||||Participants|||Count of Participants
2745715|NCT00911144|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.|Within 4 days (Days 0 to 3) after booster vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||Participants|||Count of Participants
2745719|NCT00910988|Primary|Adipose Tissue Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||% change from basal to insulin phase||Standard Deviation|Mean
2745720|NCT00910988|Primary|Peripheral Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||% change from basal to insulin phase||Standard Deviation|Mean
2745721|NCT00910988|Primary|Hepatic Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||% change from basal to insulin phase||Standard Deviation|Mean
2745722|NCT00910988|Primary|Whole Body Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||mg/kg/min||Standard Deviation|Mean
2745723|NCT00910962|Secondary|Mean Hyperenhancement Score Index at Week 12|The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68, with higher percentages indicating hyper-enhancement in a greater percentage of the tissue in a greater number of segments. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA.|At week 12|MRI ITT Population. Only those participants with data available at week 12 were analyzed.|||Scores on a scale||Standard Deviation|Mean
2745724|NCT00910962|Secondary|Mean Regional Wall Motion Score Index at Week 12|Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2745725|NCT00910962|Secondary|Mean Left Ventricular Mass at Week 12|Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||grams (gm)||Standard Deviation|Mean
2745726|NCT00910962|Secondary|Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12|Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||mL||Standard Deviation|Mean
2745727|NCT00910962|Secondary|Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12|Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent||Standard Deviation|Mean
2745728|NCT00910962|Secondary|Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12|Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|Prior to discharge (visit 1) and at Week 12|MRI ITT Population was subset of participants in the ITT Population who had at least one MRI scan. Only those participants available at the specified time points were analyzed.|||Percent of left ventricle||Standard Deviation|Mean
2745729|NCT00910962|Secondary|Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12|Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design.|At discharge and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2745730|NCT00910962|Secondary|Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design.|Up to 72 hours|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2745731|NCT00910962|Secondary|Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design.|At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72|ITT Population. Only those participants available at the specified time points were analyzed.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2745732|NCT00910962|Secondary|Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12|Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design.|24 hours post-randomization and at Weeks 2 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2745733|NCT00910962|Secondary|Mean hsCRP Over Hospitalization Period and Through Week 14|Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.|Up to Week 14|ITT Population. Only those participants available at the specified time points were analyzed.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2745734|NCT00910962|Primary|Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA.|At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours|ITT Population. Only those participants available at 72 hours were analyzed.|||nonograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2745735|NCT00910962|Primary|Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12|Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.|At Week 12|Intent-to-treat (ITT) Population comprised all randomized participants who received at least one dose of study medication and at least one on treatment assessment. Only those participants with data available at Week 12 were analyzed.|||mg per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2745736|NCT00910962|Primary|Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline|Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
2745737|NCT00910962|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline|A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal - Clinically significant at any time post-Baseline.|Up to Week 14|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2747868|NCT00892697|Primary|Intrahepatic and Plasma HCV Viral Kinetics|Intrahepatic viral kinetics, plasma viral kinetics,|Day-7, Day 1, Day 4,||||log transformed copies/ml||Standard Deviation|Mean
2745738|NCT00910962|Primary|Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline|Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
2745739|NCT00910962|Primary|Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline|Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
2745740|NCT00910962|Primary|Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline|Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
2745741|NCT00910962|Primary|Number of Participants With Any Pure MACE|Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack.|Up to Week 14|Safety Population.|||Participants|||Count of Participants
2745742|NCT00910962|Primary|Number of Participants With Any Major Adverse Cardiovascular Events (MACE)|MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization.|Up to Week 14|Safety Population|||Participants|||Count of Participants
2745743|NCT00910962|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Week 14|Safety Population consisted of all participants randomized to treatment, who had taken at least one dose of study medication.|||Participants|||Count of Participants
2745744|NCT00910910|Other Pre-specified|Number of Participants Deaths During the Treatment and Survival Follow-Up Phase|The number of study participants deaths during the treatment and follow-up phase|From the first dose of study drug up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not|||Participants|||Number
2745745|NCT00910910|Secondary|Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment|Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)|Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).|||participants|||Number
2745746|NCT00910910|Secondary|Euro Quality of Life Five Dimension (EQ-5D) Questionnaire|The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.|Day 1 and once every 8 weeks|No data were collected for the EQ-5D QOL assessment. The EQ-5D analysis was not conducted due to the discontinuation of the lenalidomide arm.||||||
2745747|NCT00910910|Secondary|Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument|The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).|Day 1 and once every 8 weeks|No data were collected for the FACT-Leu QOL assessment. Analysis was not conducted due to the discontinuation of the lenalidomide arm.||||||
2745994|NCT00909610|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2745748|NCT00910910|Secondary|Kaplan Meier Estimate for Overall Survival at the Final Analysis|Overall Survival is defined as the time between randomization and death from any cause. Overall survival was censored at the last date that the subject was known to be alive for participants who were alive as of the data cutoff date and for participants who were lost to follow-up before death was documented.|Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months|The ITT population was defined as all participants who were randomized, independent of whether they received study treatment.|||Months||95% Confidence Interval|Median
2745749|NCT00910910|Secondary|Kaplan Meier Estimate of Overall Survival|Overall Survival is defined as the time between randomization and death from any cause.|Up to data cut off of 31 March 2014; median follow-up for all participants was 18.8 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||Months||95% Confidence Interval|Median
2745750|NCT00910910|Secondary|Time to Response for a Later Cut-off Date of 31 March 2014|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 31 March 2014; up to approximately 53 months|ITT participants who had not progressed at the time of analysis; or those who had withdrawn consent or were lost to follow-up prior to documentation of progression.|||weeks||Full Range|Median
2745751|NCT00910910|Secondary|Time to Response|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|ITT participants with an objective response as of 18 February 2013|||weeks||Full Range|Median
2745752|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat population with an objective response as of 31 March 2014; includes responders.|||weeks||95% Confidence Interval|Median
2745753|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to Treat population with an objective response as of 18 Feb 2013; includes responders|||weeks||95% Confidence Interval|Median
2745754|NCT00910910|Secondary|Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:~Complete Remission (CR):~No lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~No circulating clonal B-lymphocytes~Platelets > 100,000/ul~Hemoglobin > 11.0 g/dl~Normocellular <30% lymphocytes, no B-lymphoid nodules;~Incomplete Clinical Response (CRi):~• CR without bone marrow biopsy confirmation.~Nodular Partial Response:~• CR with the presence of residual clonal nodules.~Partial Response requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul"|Up to data cut-off of 31 March 2014; approximately 53 months|The Intent-to-Treat population was defined as all participants who were randomized, independent of whether they received study treatment or not|||percentage of participants with response|||Number
2745755|NCT00910910|Secondary|Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:~Complete Remission (CR):~No lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~No circulating clonal B-lymphocytes~Platelets > 100,000/ul~Hemoglobin > 11.0 g/dl~Normocellular <30% lymphocytes, no B-lymphoid nodules;~Incomplete Clinical Response (CRi):~• CR without bone marrow biopsy confirmation.~Nodular Partial Response (nPR):~• CR with the presence of residual clonal nodules.~Partial Response (PR) requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul"|Up to data cut-off date of 18 Feb 2013; approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||percentage of participants|||Number
2745756|NCT00910910|Secondary|Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization to the data cut-off date of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).|||participants|||Number
2745781|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: CL/F|Single dose CL/F (L/h)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||L/h||Standard Deviation|Geometric Mean
2745757|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil) as of the data cut off date of 18 Feb 2013|||participants|||Number
2745758|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.|From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2745759|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression|From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The ITT population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2745760|NCT00910871|Secondary|The Percentage of Participants With Sputum Culture Conversion|The table below shows the percentage of participants who were responders to treatment. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued or died during the trial were considered non-responders.|Week 120|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.|||Percentage of Participants|||Number
2745761|NCT00910871|Primary|The Median Time to Sputum Culture Conversion|The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube [MGIT]).|Up to Week 24|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.|||Days||95% Confidence Interval|Median
2745762|NCT00910858|Secondary|Marrow-infiltrating Lymphocyte (MIL) Number and Cytolytic Activity|Due to the low number of bone marrow samples collected this analysis was not performed.|Pre-Study and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses||||||
2745763|NCT00910858|Primary|Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2745764|NCT00910858|Secondary|Change From Baseline in Bone Marrow Cellularity and Correlation With Grade 4 Myelosuppression|Bone marrow cellularity is the volume ratio of hematopoietic stem cells and adipocytes (fat cells). Due to the small number of bone marrow samples, this analysis was not performed.|Baseline and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses.||||||
2745765|NCT00910858|Secondary|Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level|To evaluate the predictive value of pretreatment serum erythropoietin (EPO) concentration for erythroid response to lenalidomide, the percentage of erythroid responders versus non-responders were stratified by Baseline EPO levels (≤ 500 mIU/mL versus > 500 mIU/mL). Response includes participants with either a major or minor response.|Assessed every 28 days until study discontinuation (up to 1218 days)|Safety population.|||percentage of participants|||Number
2745995|NCT00909610|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745766|NCT00910858|Secondary|Percentage of Participants With a Erythroid Response Across All Phases|Erythroid response was categorized as either a major response or a minor response. A major response was defined as red blood cell (RBC) transfusion independence during any consecutive 56-day period and an increase in hemoglobin of at least 1.5 g/dL. A minor response was defined as a ≥ 50% or ≥ 4 unit decrease in RBC transfusions from pretreatment requirements (the number of RBC transfusions required over an 8-week period before the start of study drug treatment).|Assessed every 28 days until study discontinuation (up to 1218 days).|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.|||percentage of participants|||Number
2745767|NCT00910858|Secondary|Time to Grade 4 Neutropenia or Thrombocytopenia|Time to the first event of grade 4 neutropenia or thrombocytopenia, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, was calculated as date of first event - date of first dose + 1.|From the date of first dose until 30 days after the last dose (up to 1218 days)|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.|||days||Full Range|Median
2745768|NCT00910858|Secondary|Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose|"Percent of the administered lenalidomide dose excreted unchanged in urine over 5 hours postdose after multiple dosing for 14 days, calculated as:~(amount excreted unchanged in urine over the first 5 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day 14, at predose and over the interval of 0-5 hours postdose.|Monotherapy Phase Pharmacokinetic Population.|||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
2745769|NCT00910858|Secondary|PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose|"Percent of the administered dose of lenalidomide excreted unchanged in urine over 24 hours postdose after a single dose on Day -7, calculated as:~(amount excreted unchanged in urine over 24 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day -7 at predose and over the intervals of 0-5, 5-8, 8-12, and 12-24 hours postdose.|PK Phase participants for whom data was available.|||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
2745770|NCT00910858|Secondary|PK Phase: Terminal Half-life (t1/2)|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|Pharmacokinetic Phase participants.|||hours||Geometric Coefficient of Variation|Geometric Mean
2745771|NCT00910858|Secondary|Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The Maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2745772|NCT00910858|Secondary|PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after a single dose on day -7.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|All Pharmacokinetic Phase participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2745773|NCT00910858|Primary|PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.|All Pharmacokinetic Phase participants.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2745774|NCT00910845|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||milliliters||Standard Deviation|Mean
2745775|NCT00910845|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||micturition episodes||Standard Deviation|Mean
2745776|NCT00910845|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||Incontinence episodes||Standard Deviation|Mean
2745777|NCT00910728|Primary|Inhibition of PSTAT3 (Count)|PSTAT3 inhinition|2hrs and 4 hrs post dose||||# patients with 50% reduction in PSTAT3|||Number
2745778|NCT00910728|Primary|Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss|Multiple dose Tmax,ss (h)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10||||h||Full Range|Median
2745779|NCT00910728|Primary|Pharamcokinetic Parameters Following Single Dosing: Tmax|Single dose Tmax (h)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)||||h||Full Range|Median
2745780|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: CLss/F|Multiple dose CLss/F (L/h)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||L/h||Standard Deviation|Geometric Mean
2745782|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: Vz/F|Single dose Vz/F (L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).~Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups."|||L||Standard Deviation|Geometric Mean
2745783|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: Cmax|Single dose Cmax (ug/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug/L||Standard Deviation|Geometric Mean
2745784|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss|Multiple dose Cmin,ss (ug/L)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug/L||Standard Deviation|Geometric Mean
2745785|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss|Multiple dose Cmax,ss (ug/L)|On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug/L||Standard Deviation|Geometric Mean
2745786|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing:AUC0-inf|Single dose AUC(0 to infinity) (ug*h/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).~From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0_inf following single dosing. With that these do not contribute."|||ug*h/L||Standard Deviation|Geometric Mean
2745787|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: AUC0-24|Single dose AUC0-24 (ug*h/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).~From the BID schedule we can not derive the single dosing AUC0_24 and hence this is not presented/calculated."|||ug*h/L||Standard Deviation|Geometric Mean
2745788|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: AUC0-12|Single dose AUC0-12 (ug*h/L)|0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug*h/L||Standard Deviation|Geometric Mean
2745789|NCT00910715|Secondary|Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.|"6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week.~For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe)."|6 months after treatment|number of participants with nonspecific symptoms|||number of participants|||Number
2745790|NCT00910715|Primary|Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.|At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.|1 year follow-up|Number of participants with complete response to treatment.|||number of participants|||Number
2745791|NCT00910689|Secondary|Change in Quality of Life at Month 16|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Scores on a scale||95% Confidence Interval|Mean
2745792|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 16|Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary.|Change form Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of Days||95% Confidence Interval|Mean
2745793|NCT00910689|Secondary|Change in Number of Migraine Episodes Per 30 Days at Month 16.|Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of Migraine Episodes||95% Confidence Interval|Mean
2745794|NCT00910689|Secondary|Change in Quality of Life at Month 10|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Scores on a scale||95% Confidence Interval|Mean
2745795|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 10|Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of days||95% Confidence Interval|Mean
2745796|NCT00910689|Primary|Change in Number of Migraine Episodes Per 30 Days at Month 10.|Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of Migraine episodes||95% Confidence Interval|Mean
2745797|NCT00910663|Primary|AUC0-t|Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
2745798|NCT00910663|Primary|AUC0-inf|Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
2745799|NCT00910663|Primary|Cmax|Bioequivalence based on Cmax - Maximum Drug Concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
2745800|NCT00910624|Secondary|Percentage of Participants With Early Virologic Response (EVR)|EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From TW 1 to TW 12|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."|||percentage of participants|||Number
2745801|NCT00910624|Primary|Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL|AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks)|All Treated Participants: All enrolled participants who received at least one dose of treatment.|||percentage of participants|||Number
2745802|NCT00910624|Primary|Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);|SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."|||percentage of participants|||Number
2745803|NCT00910520|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||milliliters||Standard Deviation|Mean
2745804|NCT00910520|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||micturition episodes||Standard Deviation|Mean
2745805|NCT00910520|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||Incontinence episodes||Standard Deviation|Mean
2745806|NCT00910299|Secondary|Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of all-cause death or MI.|Baseline through 6 months|Participants who were randomized.|||participants|||Number
2745807|NCT00910299|Secondary|Number of Participants With Stent Thrombosis (ST)|Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.|Baseline through 6 months|Participants who were randomized.|||participants|||Number
2745808|NCT00910299|Primary|Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of cardiovascular death or MI.|Baseline through 6 months|Participants who were randomized.|||participants|||Number
2745857|NCT00910091|Secondary|Duration of Response (DR) in Responders|DR is defined as period from the time that measurement criteria are first met for CR or PR until first date of documented Progressive Disease (PD) or death. DR was assessed in participants with a best overall response of CR or PR.|At 2 years|ITT population.|||Weeks||90% Confidence Interval|Median
2745809|NCT00910273|Secondary|Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52|Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; Due to limited number of participants with visits after Week 12 analysis limited to Week 12|||cm||Standard Deviation|Mean
2745810|NCT00910273|Secondary|Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52|While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
2745811|NCT00910273|Secondary|Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
2745812|NCT00910273|Secondary|Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
2745813|NCT00910273|Secondary|Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
2745814|NCT00910273|Secondary|Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
2745815|NCT00910273|Secondary|Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52|While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, 52 or ET|mITT; n= number of participants evaluable at specific time point|||degrees of movement||Standard Deviation|Mean
2745816|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point|||Units on a scale||Standard Deviation|Mean
2745817|NCT00910273|Secondary|Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52|Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745818|NCT00910273|Secondary|Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745819|NCT00910273|Secondary|Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745820|NCT00910273|Secondary|Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants with evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745821|NCT00910273|Secondary|Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745822|NCT00910273|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745823|NCT00910273|Secondary|Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52|BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score - score at observation divided by Baseline score * 100 = greater than or equal to 50%.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
2745824|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52|BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, and 52 or ET|mITT; n= number of participants evaluable at specific time point|||Units on a scale||Standard Deviation|Mean
2745825|NCT00910273|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point|||mg/liter (mg/L)||Standard Deviation|Mean
2745826|NCT00910273|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point|||mm/hr||Standard Deviation|Mean
2745827|NCT00910273|Secondary|Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52|Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; N=number of participants evaluable|||micromole/liter (µmol/L)||Standard Deviation|Mean
2745858|NCT00910091|Secondary|Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation||Up to 2 years|ITT population.|||Percentage of Participants||Standard Deviation|Mean
2745859|NCT00910091|Secondary|Percentage of Participants With Overall Response (OR) Including CR and PR||Up to 2 years|ITT population.|||Percentage of Participants||Standard Deviation|Mean
2745828|NCT00910273|Secondary|Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2745829|NCT00910273|Secondary|Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52|Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation.|Baseline, Week 12 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable|||mm||Standard Deviation|Mean
2745830|NCT00910273|Secondary|Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52|BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) * 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation.|Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)|mITT; n=number of participants evaluable at specific time point|||percentage of BA diameter||Standard Deviation|Mean
2745831|NCT00910273|Primary|Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12|Brachial artery (BA) FMD equals (=)(maximum diameter minus[-] baseline diameter divided by baseline diameter) times (*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.|Baseline, Week 12|Modified Intent to Treat Population (mITT): all randomized participants who received at least one dose of test article followed by at least one available evaluation; n=number of participants evaluable at specific time point|||percentage of BA diameter||Standard Deviation|Mean
2745832|NCT00910247|Secondary|Completion Rate (% of Subjects Completing Each Visit Post-one Year).|Completion rate (% of subjects completing each visit post-one year).|post 1 year|The intent-to-treat (ITT) subjects who entered the post - 1- year open -label period.|||percentagae of participants|||Number
2745833|NCT00910247|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening|The total score of MADRS is defined as the sum of all individual item scores . Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.|baseline and Month 12|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||units on a scale||Standard Deviation|Mean
2745834|NCT00910247|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).|The total score of MADRS is defined as the sum of all individual item scores. Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||units on a scale||Standard Deviation|Mean
2745835|NCT00910247|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|"Change in the overall score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31 )~The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life."|baseline and Month 12|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||units on a scale||Standard Deviation|Mean
2745836|NCT00910247|Secondary|Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)|The retention time is defined from the start of eslicarbazepine acetate monotherapy period in 093-045 or 093-046 to the last known dose of open-label eslicarbazepine acetate. The time may include taking eslicarbazepine acetate concomitantly with other anti-epileptic drugs. If a subject's termination reason(s) includes: withdrawal of consent, lost to follow-up, physician decision or other, then it was assumed the subject terminated the study due to lack of efficacy.|One year|Intent-to-treat (ITT) subjects who started the monotherapy period in 093-045 or 093-046 (visi t6/week 8)|||days||95% Confidence Interval|Median
2745837|NCT00910247|Secondary|Completion Rate (% of Subjects Completing the One Year Treatment)|Completion rate (% of subjects completing the one year treatment)|One year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentagae of participants|||Number
2745838|NCT00910247|Secondary|Percentage of Subjects That Are Seizure-free During Study|Percentage of subjects that are seizure-free during study|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentage of participants|||Number
2745839|NCT00910247|Secondary|Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).|One year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentage of participants|||Number
2745840|NCT00910247|Secondary|Change in Seizure Frequency From Baseline.|Relative (%) change in standard seizure frequency(SSF) from baseline|Month 12 from baseline|Intent-to-treat (ITT) population consisted of all subjects who had taken any open-label study medication|||percent change||Inter-Quartile Range|Median
2745996|NCT00909545|Secondary|Common Adverse Events: Hypotension|Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2745841|NCT00910247|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other anti-epileptic drugs while taking study medication. Time on eslicarbazepine acetate monotherapy is defined from the date of the first monotherapy dose in 093-045 or 093-046 study to the last known dose of monotherapy treatment, regardless of dose change and the time gap between the parent studies and the current study.|One year|ITT Subjects who started the monotherapy period (Visit 6/Week 8) in 093-045 or 093-046 and did not add a non-rescue/emergency Antiepileptic drug (AED) during the start date of the monotherapy period|||Days||95% Confidence Interval|Median
2745842|NCT00910247|Secondary|Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).|"The C-SSRS is an instrument designed to systematically assess and track suicidal behavior and suicidal ideation. The C-SSRS will be completed by the Investigator or Sub-Investigator (or qualified site personnel).~Suicidal ideation is collected as any occurrence of wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent.~Suicidal behavior is collected as any occurrence of actual attempts, Non-Suicidal Self-Injurious Behavior, interrupted attempts, aborted attempts, or preparatory acts or behavior, suicidal behavior.~Any suicidality is defined as having at least one occurrence of Suicidal Behavior or Suicidal Ideation."|1 year|The Intent-to-Treat (ITT) population consisted of all subjects that received any open-label study medication|||percentage of events|||Number
2745843|NCT00910247|Secondary|Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.|"Number and percentage of subjects by QT interval corrected using the Fridericia fomula (QTcF) categories~Based on the numbers of subjects who had at least one post-baseline assessment, the number and percentage of subjects with QTcF values in the following categories were summarized:~>500 millisecond (msec) at any post-baseline timepoint but not present at baseline~>480 msec at any post-baseline timepoint but not present at baseline~>450 msec at any post-baseline timepoint but not present at baseline~Change from Baseline >=60 ms for at least one post-baseline measurement~Change from Baseline >=30 ms for at least one post-baseline measurement and <60 ms for all post-baseline measurement~QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle."|Baseline, Month 12|The intent-to-treat (ITT) subjects with at least one post-baseline assessment|||Participants|||Count of Participants
2745844|NCT00910247|Secondary|Number and Percentage of Subjects With Orthostatic Effects.|Number and percentage of subjects with orthostatic effects.|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||Participants|||Count of Participants
2745845|NCT00910247|Secondary|Percentage of Subjects With Increase of Body Weight ≥7%|Percentage of subjects with increase of body weight ≥7%|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentagae of participants|||Number
2745846|NCT00910247|Secondary|Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Number and percentage of subjects who had normal sodium value (i.e. >135 mEq/L) at baseline but reached <=135 mEq/L and >130 mEq/L, <=130 mEq/L and >125 mEq/L, or <=125 mEq/L at any post baseline.|1 year|ITT subjects with baseline sodium and at least one post baseline sodium value|||Participants|||Count of Participants
2745847|NCT00910247|Secondary|Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations|Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||Participants|||Count of Participants
2745848|NCT00910247|Primary|Number and Percent of Subjects With Treatment Emergent Adverse Events|Number and percent of subjects with treatment emergent adverse events|One year|The Intent-to -Treat (ITT) population consisted of all subjects who had taken any open-label study medication|||Participants|||Count of Participants
2745849|NCT00910208|Secondary|Need for Supplementary Analgesia|count of participants who needed or did not needed additional analgesia|2 hours post treatment||||Participants|||Count of Participants
2745850|NCT00910208|Primary|Safety: Incidence of Adverse Events|Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)|2 hours||||Participants|||Count of Participants
2745851|NCT00910208|Primary|Long Term Efficacy: Pain Relief by 120 Minutes|Participants aksed to and give range|120 minutes||||Participants|||Count of Participants
2745852|NCT00910208|Primary|Long Term Efficacy: Total Analgesia Provided Over 2 Hours|"Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain~Total analgesia is measured by a summary of change in pain that varies from 0 - no change to"|Baseline, 30, 60, 90, 120 post-treatment||||scores on a scale *minutes||95% Confidence Interval|Mean
2745853|NCT00910208|Primary|Participants With Short Term Efficacy: Pain Relief by 30 Minutes|Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)|30 minutes post treatment||||Participants|||Count of Participants
2745854|NCT00910208|Primary|Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale|Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.|Baseline and 30 minutes post treatment||||Units on a scale||95% Confidence Interval|Mean
2745855|NCT00910091|Secondary|Progression Free Survival (PFS): Time From Randomisation Until Objective Tumour Progression or Death From Any Cause||Up to 2 years||||Weeks||90% Confidence Interval|Median
2745856|NCT00910091|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause.|At 2 years|ITT population.|||Weeks||90% Confidence Interval|Median
2747869|NCT00892606|Secondary|Visual Pain Score|Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain|48 hours||||units on a scale||Standard Deviation|Mean
2745860|NCT00910091|Secondary|Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks|"CR: Disappearance of all known disease & no new sites / disease related symptoms confirmed at least 12 weeks after initial documentation. Disappearance of all non-target lesions. Normalization of tumor marker level confirmed at least 12 weeks after initial documentation.~PR: Minimum 30% decrease in sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 12 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Up to 2 years|ITT population.|||Percentage of Participants||Standard Deviation|Mean
2745861|NCT00910091|Secondary|Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is a participant answered questionnaire scoring 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Up to week 32|"ITT population.~Three subjects withdrawn the consent from MA 160 mg group and did not have EuroQoL score up to week 32."|||Percentage of participants|||Number
2745862|NCT00910091|Secondary|Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions|Percentage of participants who had dose interruptions and reason for interruptions as AE, study treatment forgotten, and other reasons.|Up to 2 years|Safety Population|||Percentage of participants|||Number
2745863|NCT00910091|Secondary|Tolerability of BN83495 Based on Cumulative Dose Administered|Cumulative dose is the actual total dose administered.|Up to 2 years|"Safety Population~Missing number of subjects = 2"|||mg||Standard Deviation|Mean
2745864|NCT00910091|Secondary|Tolerability of BN83495 Based on Length of Exposure|Length of exposure includes interruptions.|Up to 2 years|Safety Population|||Week||Standard Deviation|Mean
2745865|NCT00910091|Secondary|Percentage of Participants With Adverse Event (AE)|Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening/disabling and Grade 5: Death|Up to Day 28 follow-up|Safety Population: All randomised subjects who received at least one dose of study medication.|||Percentage of subjects|||Number
2745866|NCT00910091|Primary|Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died|Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).|Up to 6 months|Intent-to-treat (ITT) population includes all randomized subjects who received at least one dose of study medication.|||Percentage of subjects||90% Confidence Interval|Number
2745867|NCT00910039|Secondary|Safety and Tolerability|Number of patients that experienced treatment-related G 3-4 adverse events.|3 years from study start||||participants|||Number
2745868|NCT00910039|Secondary|Neurocognitive Effects|The number of patients that had statistically significant change (p's > 0.05) in their neurocognitive assessment (improvement or decline) from baseline. Neurocognitive function was assessed in several domains, including memory, verbal fluency, visual-motor speed, executive function and motor dexterity.The difference between the pre-treatment baseline and follow-up assessment scores were determined by the reliable change (RC) index. RC Index: 1=deterioration, 2=no change, 3=improved|at 2 months after treatment|Due to the small number of patients accrued there was not enough data for analysis of this outcome.||||||
2745869|NCT00910039|Secondary|Rate of Local Failure at 12 Months|Rate of local vs regional failure -rates of progression at site of stereotactic radiosurgery (local failure)vs progression anywhere else in CNS (regional failure).|12 months|Due to the small number of patients accrued there was not enough data for analysis of this outcome.||||||
2745870|NCT00910039|Secondary|Time to Progression|Time to progression (all sites of disease) - interval between stereotactic radiosurgery and the earliest date of progression (systemic or CNS) or death due to any cause.|at 3 yrs from SRS||||months||95% Confidence Interval|Median
2745871|NCT00910039|Secondary|Overall Survival|The number of subjects surviving at least 12 months from stereotactic radiosurgery.|12 months from SRS|Intent to treat|||participants|||Number
2745872|NCT00910039|Secondary|Median Time to CNS Disease Progression|Time to disease progression will be recorded from the first day of protocol therapy until the criteria for disease progression are met, patient death from any cause or removal of the patient from study for any reason, whichever comes first.|up to12 months from SRS|Intent to treat|||months||95% Confidence Interval|Median
2745873|NCT00910039|Secondary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least 12 months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald's standard criteria. Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|12 months after stereotactic radiosurgery (SRS)|Intent to treat|||participants|||Number
2745874|NCT00910039|Primary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least six months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald's standard criteria.Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|6 months after stereotactic radiosurgery (SRS)|Intent to treat|||participants|||Number
2745997|NCT00909545|Secondary|Common Adverse Events: Back Pain|Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2747870|NCT00892606|Secondary|Number of Participants With Post Operative Nausea and Vomiting|rates subjects experienced PONV|48 hours||||Participants|||Count of Participants
2745875|NCT00910000|Secondary|Response|Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable.|Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).||||participants|||Number
2745876|NCT00910000|Primary|Dose Limiting Toxicity (DLT) [Phase Ib]|"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:~Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.~Any of the following hematologic events (excluding neutropenia lasting < 5 days):~i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.~ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia~Any clinically significant abnormal laboratory value that results in dose delay of >14 days.~<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity."|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, DLT evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final DLT dataset was comprised of all enrolled and treated participants.|||participants with DLT|||Number
2745877|NCT00910000|Primary|Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]|The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, MTD evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final MTD dataset was comprised of all enrolled and treated participants.|||mg/day|||Number
2745878|NCT00909870|Other Pre-specified|Complete Healing by Week 16: Ulcers <= 12 Months Duration||16 weeks|Pre-specified Subgroup of the Intent-to-Treat Population|||participants|||Number
2745879|NCT00909870|Secondary|Time-to-Complete Healing|Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.|"From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the time until CH was censored at 112 days."|Intent-to-Treat population|||days||Inter-Quartile Range|Median
2745880|NCT00909870|Primary|Complete Healing of the Study Ulcer by Week 16.||16 weeks|Intent-to-Treat population|||participants|||Number
2745881|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745882|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745883|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745884|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745885|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745886|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745887|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745888|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745889|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745890|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745891|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745892|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants wit assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745903|NCT00909857|Secondary|Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745893|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745894|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745895|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|at final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745896|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745897|NCT00909857|Secondary|Participants With Improvement in Participants' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Participants|||Number
2745898|NCT00909857|Secondary|Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Participants|||Number
2745899|NCT00909857|Secondary|Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745900|NCT00909857|Secondary|Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745901|NCT00909857|Secondary|Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745902|NCT00909857|Secondary|Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745904|NCT00909857|Secondary|Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745905|NCT00909857|Secondary|Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745906|NCT00909857|Secondary|Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745907|NCT00909857|Secondary|Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
2745908|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745909|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745910|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At Baseline (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745911|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At screening (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available|||Percentage of Participants|||Number
2745912|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of participants|||Number
2745913|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of participants|||Number
2745998|NCT00909545|Secondary|Common Adverse Events: Sinusitis|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2745914|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745915|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745916|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745917|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745918|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2745919|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2745920|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745921|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745922|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745923|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745924|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745925|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745926|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745927|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745928|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745929|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
2745960|NCT00909844|Secondary|Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test|A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0 and 36|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||percentage of patients||95% Confidence Interval|Number
2745930|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Spotting Only Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745931|NCT00909857|Secondary|Maximum Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745932|NCT00909857|Secondary|Mean Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745933|NCT00909857|Secondary|Number of Episodes With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2745934|NCT00909857|Secondary|Number of Days With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745935|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745936|NCT00909857|Secondary|Maximum Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745961|NCT00909844|Secondary|Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)|Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 36 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
2745937|NCT00909857|Secondary|Mean Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745938|NCT00909857|Secondary|Number of Episodes With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2745939|NCT00909857|Secondary|Number of Days With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745940|NCT00909857|Secondary|Percentage of Participants Satisfied With Study Treatment|Participants were asked to express the degree of their satisfaction with study treatment.|From cycle 1 to cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of participants|||Number
2745941|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available|||Percentage of Participants|||Number
2745942|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available|||Percentage of participants|||Number
2745943|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
2745944|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
2745945|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding|Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745946|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding|Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745947|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain|Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2745948|NCT00909857|Primary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain|Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
2745949|NCT00909844|Post-Hoc|Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6)|One secondary efficacy endpoint in this study was the percentage of children who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage at the end of the study. Results reported for this secondary endpoint applied the variable 'Final Visit' for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of children with regression or stabilisation of Tanner pubic hair pubertal stage was performed which applied the derived variable 'Last Visit on Treatment' for comparison to the Pretreatment stage. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.|Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.|||percentage of patients|||Number
2745950|NCT00909844|Post-Hoc|Percentage of Girls With a Stabilisation or Regression of Tanner Breast Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6) and Baseline (Month 0)|One primary efficacy endpoint was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of girls maintaining a regression or stabilisation of sexual maturity (based on Tanner breast pubertal stage) until end of study. Results reported for this primary endpoint applied the variable 'Final Visit' for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of girls with regression or stabilisation of Tanner breast pubertal stage was performed which applied the derived variable 'Last Visit on Treatment' to compare to the Pretreatment stage and to Baseline. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.|Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.|||percentage of patients||95% Confidence Interval|Number
2745988|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2747871|NCT00892606|Primary|Opioid Consumption During the 48 Hours After Surgery|The amount of opioid required for postoperative pain relief|48 hours||||mg||Standard Deviation|Mean
2745951|NCT00909844|Secondary|Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)|Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.|Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.|||percentage of patients||95% Confidence Interval|Number
2745952|NCT00909844|Secondary|Percentage of Girls With a Uterine Length < 36 Millimetres (mm)|Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||percentage of patients||95% Confidence Interval|Number
2745953|NCT00909844|Secondary|Bone Age Maturation|Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||years||Standard Deviation|Mean
2745954|NCT00909844|Secondary|Predicted Adult Height SD Score|Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.|Months -6, 0, 12 and Final Visit (up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
2745955|NCT00909844|Secondary|Auxological Parameters Variations: Weight Variation|Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||kg||Standard Deviation|Mean
2745956|NCT00909844|Secondary|Auxological Parameters Variations: Growth Velocity SD Score|Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
2745957|NCT00909844|Secondary|Auxological Parameters Variations: Height SD Score|Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
2745958|NCT00909844|Secondary|BMI Standard Deviation (SD) Score for Chronological Age Variation|Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
2745959|NCT00909844|Secondary|Body Mass Index (BMI) for Chronological Age Variation|Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||kilograms per metre squared (kg/m^2)||Standard Deviation|Mean
2745989|NCT00909610|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745962|NCT00909844|Secondary|Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test|A suppressed LH response to the GnRH test was defined as a stimulated peak of LH ≤3 international units per litre (IU/L). Percentage of patients who had a suppressed LH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0 and 36|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||percentage of patients||95% Confidence Interval|Number
2745963|NCT00909844|Primary|Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)|The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast [girls] or genital [boys] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.|Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.|||percentage of patients||95% Confidence Interval|Number
2745964|NCT00909792|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.|||logMAR||Standard Deviation|Mean
2745965|NCT00909779|Secondary|Inspiratory Capacity (IC): Mean Change From Baseline|"IC: the total amount of air that can be drawn into the lungs after normal expiration.~IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline."|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Least Squares Mean
2745966|NCT00909779|Secondary|Forced Vital Capacity (FVC): Mean Change From Baseline|Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Least Squares Mean
2745967|NCT00909779|Secondary|Percent Predicted FEV1: Mean Change From Baseline|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1."|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Least Squares Mean
2745968|NCT00909779|Secondary|FEV1: Mean Change From Baseline|FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Mean
2745969|NCT00909779|Secondary|SGRQ: Mean Change From Baseline in Total Score|The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer's guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.|Baseline and on treatment at months 3, 6 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Score||Standard Error|Least Squares Mean
2745970|NCT00909779|Secondary|The Incidence of Treatment Emergent AEs|"TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.~The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated."|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
2745971|NCT00909779|Secondary|The Incidence of All Cause Mortality|Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
2745972|NCT00909779|Secondary|The Incidence of Protocol Defined COPD Exacerbations.|A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
2745973|NCT00909779|Primary|Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).|COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit > 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a 'probable cause', which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered 'UNKNOWN'. Cause other than 'UNKNOWN' was categorized as either respiratory or non-respiratory. Deaths of 'UNKNOWN' cause were counted as primary events.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Days|Participants|Standard Deviation|Mean
2745974|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2745975|NCT00909753|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745976|NCT00909753|Primary|AUC0-72 for Total Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2745977|NCT00909753|Primary|Cmax for Total Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745978|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2745979|NCT00909753|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745980|NCT00909753|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2745981|NCT00909753|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2745982|NCT00909727|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||kilograms||Standard Error|Least Squares Mean
2745983|NCT00909727|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||millimoles per liter||Standard Error|Least Squares Mean
2745984|NCT00909727|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Through Week 24 and Week 48 (Respiratory Domain Score, Children)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||score on a scale||Standard Error|Least Squares Mean
2745985|NCT00909727|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||percent of predicted volume (L)||Standard Error|Least Squares Mean
2745986|NCT00909727|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo)and had available assessments during the time frame.|||percent of predicted volume (L)||Standard Error|Least Squares Mean
2745987|NCT00909649|Primary|Seroma Formation|the mean total drainage volume|within 30 days postoperative|ITT|||ml||Standard Deviation|Mean
2774925|NCT00706966|Secondary|Total PSA Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.|||ng/mL||Standard Deviation|Mean
2745999|NCT00909545|Secondary|Common Adverse Events: Diarrhoea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746000|NCT00909545|Secondary|Common Adverse Events: Dyspepsia|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746001|NCT00909545|Secondary|Common Adverse Events: Insomnia|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746002|NCT00909545|Secondary|Common Adverse Events: Somnolence|Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746003|NCT00909545|Secondary|Common Adverse Events: Depression|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746004|NCT00909545|Secondary|Common Adverse Events: Upper Respiratory Tract Infection|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746005|NCT00909545|Secondary|Common Adverse Events: Nausea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746006|NCT00909545|Secondary|Common Adverse Events: Fatigue|General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746007|NCT00909545|Secondary|Common Adverse Events: Constipation|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746008|NCT00909545|Secondary|Common Adverse Events: Headache|Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746009|NCT00909545|Secondary|Common Adverse Events: Nasopharyngitis|Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746010|NCT00909545|Secondary|Common Adverse Events: Dizziness|Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746011|NCT00909545|Secondary|Common Adverse Events: Oedema Peripheral|General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746012|NCT00909545|Secondary|Vital Signs: Change in Pulse Supine||Baseline to 12 months or the time to require dopaminergic therapy||||beats per minute||Standard Error|Least Squares Mean
2746013|NCT00909545|Secondary|Vital Signs: Change in Pulse Standing||Baseline to 12 months or the time to require dopaminergic therapy||||beats per minute||Standard Error|Least Squares Mean
2746014|NCT00909545|Secondary|Vital Signs: Change in Diastolic Supine||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
2746015|NCT00909545|Secondary|Vital Signs: Change in Diastolic Standing||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
2746016|NCT00909545|Secondary|Vital Signs: Change in Systolic Supine||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
2746017|NCT00909545|Secondary|Vital Signs: Change in Systolic Standing||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
2746018|NCT00909545|Secondary|Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)|The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746019|NCT00909545|Secondary|Efficacy: Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746650|NCT00904826|Secondary|Number of Subjects With Change in Ambulation by at Least 1 Point|Ambulation was measured by the Hauser Ambulation Index, which ranges from 0 (asymptomatic; fully active) to 9 (restricted to wheelchair; unable to transfer self independently.)|12 months||||participants|||Number
2746020|NCT00909545|Secondary|Efficacy: Change in Beck Depression Inventory II (BDI-II)|The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746021|NCT00909545|Secondary|Efficacy: Change in Modified Schwab & England Independence Scale|The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability).|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746022|NCT00909545|Secondary|Efficacy: Change in Modified Hoehn & Yahr Scale|The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746023|NCT00909545|Secondary|Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746024|NCT00909545|Secondary|Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in the primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746025|NCT00909545|Secondary|Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were used in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
2746026|NCT00909545|Primary|Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.|Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
2746027|NCT00909545|Secondary|Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|Participants are 99 subjects with early Parkinson disease not requiring dopaminergic therapy.|||Scores on a scale||Standard Error|Least Squares Mean
2746028|NCT00909532|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||kilograms||Standard Error|Least Squares Mean
2746029|NCT00909532|Secondary|Time-to-first Pulmonary Exacerbation Through Week 24 and Week 48|Pulmonary exacerbation was defined as a change in antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of signs/symptoms such as change in sputum; new or increased hemoptysis; increased cough or dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees C; anorexia or weight loss; sinus pain/tenderness and discharge; change in physical examination of the chest; decreased pulmonary function by 10%; and radiographic changes indicative of pulmonary infection.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||proportion of event-free participants||95% Confidence Interval|Number
2746030|NCT00909532|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..|||millimoles per liter||Standard Error|Least Squares Mean
2746031|NCT00909532|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score Through Week 24 and Week 48 (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||score on a scale||Standard Error|Least Squares Mean
2746032|NCT00909532|Secondary|Absolute Mean Change From Baseline in Percent Predicted FEV1 Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..|||percent of predicted volume (L)||Standard Error|Least Squares Mean
2746033|NCT00909532|Primary|Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||percent of predicted volume (L)||Standard Error|Least Squares Mean
2746034|NCT00909480|Secondary|"Number of Subjects Having the Adverse Event Incorrect Dose Administered"|"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications"|Weeks 0-26|Safety Analysis Set: All subjects that received at least one dose of the trial product.|||Subjects|||Number
2746035|NCT00909480|Secondary|Change in Body Weight From Baseline||Week 0, Week 26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||kg||Standard Deviation|Mean
2746036|NCT00909480|Secondary|Hypoglycemic Episodes, Unclassifiable|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2746037|NCT00909480|Secondary|Hypoglycaemic Episodes, Nocturnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2746038|NCT00909480|Secondary|Hypoglycaemic Episodes, Diurnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2746039|NCT00909480|Secondary|Incidence of Hypoglycaemic Episodes During the Trial|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2746040|NCT00909480|Secondary|Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)|Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||mmol/L||Standard Deviation|Mean
2746041|NCT00909480|Secondary|Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast|The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||mmol/L||Standard Deviation|Median
2746042|NCT00909480|Secondary|Fasting Plasma Glucose (FPG)||Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||mmol/L||Standard Deviation|Mean
2746043|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage (%) of subjects|||Number
2746044|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%|The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage (%) of subjects|||Number
2746045|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage (%) of subjects|||Number
2746046|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%|The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage of subjects|||Number
2746047|NCT00909480|Primary|Change in HbA1c From Baseline||Week 0, Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage point change||Standard Deviation|Mean
2746048|NCT00909428|Primary|Change in Maximal Cystometric Capacity (mL)|At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.|30 Days|The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis.|||milliliters (mL)||Inter-Quartile Range|Median
2746049|NCT00909389|Primary|Number of Participants Who Had an Adverse Event (AE).|"The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia.~All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE."|Throughout study up to Day 29 (Final Visit)||||participants|||Number
2746050|NCT00909363|Secondary|How Many Patients With WAS Had Substantially Increased Platelet Production After Eltrombopag|in how many patients with WAS did eltrombopag increase platelet production as measured by the immature platelet fraction (IPF), a variable derived from the Sysmex auto analyzer, which is considered to be a measure of newly formed platelets ie reticulated platelets|12 weeks|1 subject withdrew prior to starting treatment and was not included in the analysis. no treatment with eltrombopag was given to healthy volunteers and WAS patients who were blood drawing only so the effect of treatment in these 2 groups could not be assessed|||Participants|||Count of Participants
2746051|NCT00909363|Secondary|How Many Patients With WAS Had Abnormal Platelet Function Including Activation|in how many patients with WAS were platelets dysfunctional or activated before treatment as measured by flow cytometry to a substantial degree and the same after treatment with eltrombopag|12 weeks|1 subject withdrew prior to starting treatment and was not included in the analysis|||participants|||Number
2746052|NCT00909363|Secondary|Number of Patients With Wiskott-Aldrich Syndrome (WAS) With Grade 3 or Higher Bleeding or SAE (on WHO Scale)|number of patients with bleeding SAEs while on treatment and/or number of patients with grade 3 or higher bleeding on WHO (World Health Organization) scale: the scale is from 1 to 5 with 5 = fatality and 1=very little bleeding|12 Weeks|1 subject withdrew prior to starting treatment and was not included in the analysis|||participants|||Number
2746053|NCT00909363|Primary|How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul.|number of WAS patients achieving this increase to > 50,000/uL without rescue medication in the previous 3 weeks during eltrombopag treatment|12 weeks|"1 WAS subject withdrew prior to starting treatment and was not included in the analysis.~Healthy volunteers were neither WAS patients nor received eltrombopag (both required for achievement of primary outcome #1). The WAS patients who were blood draw only also were 0 since they did not receive eltrombopag."|||participants|||Number
2746054|NCT00909324|Secondary|Change in the Results of Schirmer's Test From Baseline to End of Study|Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.|||mm||Standard Deviation|Mean
2746055|NCT00909324|Secondary|Change in Tear Breakup Time From Baseline to End of Study|The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.|||Seconds||Standard Deviation|Mean
2746056|NCT00909324|Primary|Change in Ocular Comfort Level From Baseline to End of Study|Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.|||Units on a scale||Standard Deviation|Mean
2746148|NCT00908544|Secondary|Median Change in Relative CD4+T Cells Over Time|Median Change from baseline (IQR, interquartile range) in relative CD4+T cells/µl.|Change from baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||percentage of Lymphocytes||Inter-Quartile Range|Median
2746057|NCT00909220|Primary|A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).|The negativity bias, characterized as the tendency to evaluate unpleasant versus pleasant information as more important, was measured using a computer task. Sitting in front of the computer, participants viewed emotionally evocative images and assigned their evaluations of how the intensity of these emotional images using a grid. The grid is comprised of a matrix, with 5 points on the horizontal axis representing the positivity seen in the image (0=not at all, 4 = extremely positive) by 5 points on a vertical axis representing the negativity seen in the image (0=not at all, 4 = extremely negative) matrix. The dimensional variable, negativity bias, is calculated as the difference in the mean ratings of very unpleasant images minutes the positive ratings of the very pleasant images. The Inventory of Depressive Symptomatology, Self-Rated (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity provided by the participant.|Weeks 0-16|First level units were 'weeks in BA treatment', with participants limited to those diagnosed with MDD and who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'MDD subjects entering treatment' (n = 41)|||slope||Standard Error|Geometric Least Squares Mean
2746058|NCT00909220|Primary|Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment|Frontal EEG asymmetry scores were calculated over the midfrontal sites, subtracting the natural log of the alpha power of the electrode in the left hemisphere (F3 or F7) from that of the right frontal electrode (F4 or F8), creating one summary alpha asymmetry variable. The absolute value of this difference score was taken. Using the natural log transformation is used in EEG asymmetry research as EEG power appears to be positively skewed. A higher score thus reflected greater relative left versus right frontal activation (e.g., relatively higher right alpha activity).|Week 0||||Alpha power||Standard Error|Mean
2746059|NCT00909220|Primary|Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Patient-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.|The Inventory of Depressive Symptomatology, Self-Rated measure (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity completed by the participant. The item scores on this scale are summed to create a total score (range from 0 (no symptoms) to 84 (highest severity). The item scores on this scale are summed to create a total score (range from 0 (minimum score reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Severity of depression is reflected by total score (e.g., scores between 0-13 is interpreted as 'no depression', scores between 14-25 are interpreted as 'mild severity'; total scores between 26-48 are interpreted as 'severe', and total scores between '49-84' are interpreted as 'very severe'.|Week 16|Intent to treat sample.|||units on a scale||Standard Deviation|Mean
2746060|NCT00909220|Primary|Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.|The Inventory of Depressive Symptomatology-Clinician Rated measure (IDS-C; Rush, Giles, Schlesser, Fulton, Weissenburger, Burns, 1986; Rush, Carmody, & Reimitz, 2000; Rush, Trivedi, Ibrahim, Carmody, Arnow, Klein, et al., 2003) is a 30-item measure that reflects the presence and severity of DSM-IV symptoms of depression. The item scores on this scale are summed to create a total score. Scores range from 0 (minimum score, reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Scores between 0-11 are interpreted as 'no depression'; scores between 12-23 are interpreted as 'mild severity'; scores between 24-36 are interpreted as 'severe'; and total scores between '47-84' are interpreted as 'very severe'.|Week 16|Intent to treat sample.|||units on a scale||Standard Deviation|Mean
2746061|NCT00909181|Primary|Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12|Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.|12 weeks|mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment|||Episodes||Standard Deviation|Mean
2746062|NCT00909155|Primary|Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.|"Depressed participants were scanned while viewing a sequence of positive and negative images; they were instructed to enhance or supress their emotional response to the image or to continue to attend. To examine brain function when regulating negative affect, we created contrast maps for each participant at all 3 time points by subtracting the attend condition from the suppress condition in response to negative stimuli. Data from all 3 scan sessions were used to assess treatment-induced change in brain activity when regulating emotion. Analyses examining change using difference scores (end vs. starting points), we subtracted initial HAMD score from final HAMD score. For fMRI analyses, in a voxelwise manner, we subtracted initial negative suppress vs attend from final negative suppress vs attend.~Control subjects were not depressed, repeat scans to assess change were not completed.~Reported results are from BA10, one of our areas of interest."|At study entry, 2 months and end of study (6 months)|Depressed subjects were treated with an SSRI or an SNRI, and assessed at 3 time points on an fMRI emotional response task. Differences in depression scores and changes in the fMRI responses were analyzed for changes to better understand the association between emotion regulation, depression, and treatment response.|||fMRI signal change||Standard Deviation|Mean
2746063|NCT00909155|Primary|Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales|"Hamilton Depression rating scale is a clinician assessment tool to measure severity of depression symptoms. Minimum score is 0 (no symptoms); maximum score is 52 (severe symptoms of depression).~Hamilton Anxiety rating scale is a clinician assessment tool to measure severity of anxiety symptoms. Minimum score is 0 (no symptoms); maximum score is 56 (severe symptoms of anxiety)."|Study entry, 2 months, and at end of study (6 mos)||||units on a scale||Standard Deviation|Mean
2746064|NCT00909064|Secondary|Incidence of Wound Infection|Incidence of Cellulitis in patients undergoing Arixtra treatment|Up to 10 days||||Participants|||Count of Participants
2746065|NCT00909064|Secondary|Number of Days in Hospital.|Days after surgery to dischage|Up to 10 days||||days||Standard Deviation|Mean
2746066|NCT00909064|Primary|Number of Days Until a Dry Wound|Days from day of surgery to stoppage of leakage from the wound|Up to 10 days||||days||Standard Deviation|Mean
2746067|NCT00909038|Secondary|Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007|The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.|Baseline to a minimum of 8 weeks of treatment|Per protocol set (PPS)|||percentage of patients|||Number
2746068|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mmHg||Standard Deviation|Mean
2746069|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mmHg||Standard Deviation|Mean
2746070|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mm Hg||Standard Deviation|Mean
2746071|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mm Hg||Standard Deviation|Mean
2746072|NCT00909038|Primary|Rate of BP Control in Hypertensive Patients|"Percentage of controlled Patients at the Study End.~Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines."|Baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||Percentage of Participants||95% Confidence Interval|Number
2746073|NCT00908960|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Assessed up to approximately 30 months|The analysis dataset is comprised of all evaluable patients.|||months||95% Confidence Interval|Median
2746074|NCT00908960|Secondary|Incidence of Major Hemorrhage Events|Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)|Assessed during the 60 day therapy|The analysis dataset is comprised of evaluable patients.|||Participants|||Count of Participants
2746075|NCT00908960|Primary|2-Month Cumulative Incidence of VTE|2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.|Assessment with lower extremity ultrasound occured at day 60/ month 2|The analysis dataset is comprised of all evaluable patients.|||percent probability||95% Confidence Interval|Number
2746076|NCT00908947|Secondary|Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure|The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure.|30-days, and 12-, 24-, and 36-months post-index procedure|(n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Score on a Scale||Standard Deviation|Mean
2746077|NCT00908947|Secondary|Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure|Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 2.5, and PSR < 3.0.|12, 24, and 36 Months Post-Index Procedure|The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=160 instead of N=173.|||Probability of Target Lesion Patency|Lesions|90% Confidence Interval|Number
2746078|NCT00908947|Secondary|Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure|Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 3.0.|12, 24, and 36 months Post-Index Procedure|The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=161 instead of N=173.|||Probability of Lesion Patency|Lesion|90% Confidence Interval|Number
2746079|NCT00908947|Secondary|Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure|Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR < 2.5.|24- and 36-months post-index procedure|The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (24 and 36 months). Therefore n=161 instead of N=173.|||Probability of sustained lesion patency||90% Confidence Interval|Number
2746080|NCT00908947|Secondary|Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure|Sustained clinical success is defined as sustained cumulative improvement from baseline value of ≥ 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects.|30-days and 12-, 24-, and 36-months post-index procedure|(n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section|||Participants|||Count of Participants
2746081|NCT00908947|Secondary|Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure|Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects.|30 days, 12-, 24-, and 36-months post-index procedure|The number of participants for each time period represents the evaluable subjects for this specific outcome measure.|||Participants|||Count of Participants
2746082|NCT00908947|Secondary|Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure|Sustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure.|24- and 36-months post-index procedure||||Probability of Freedom from TLR or TRV||90% Confidence Interval|Number
2746083|NCT00908947|Secondary|Number of Procedures With Acute Success|Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel).|Intra-procedure|One patient died at day 22, therefore, in this analysis N=172 instead of N=173.|||Procedures|Procedures||Count of Units
2746084|NCT00908947|Secondary|Number of Acute Lesion Success|Acute lesion success is defined as attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data.|Intra-procedure|N=175 (lesions) differs from the baseline characteristics module that mentions 187 treated lesions due to availability of angiographic image that show less than, or equal to 30% residual stenosis post-dilatation, as evaluated by the independent core-lab at time of analysis.|||Target lesions|Target lesions||Count of Units
2746085|NCT00908947|Secondary|Number of Stents Deployed With Acute Technical Success|Acute technical success is defined as successful deployment of the stent to the intended location.|Intra-procedure||||Stents|Stents||Count of Units
2746086|NCT00908947|Secondary|Secondary Safety Endpoint: Freedom From Composite Adverse Events|Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure.|30-days and 12-, 24-, and 36-months post-index procedure|(n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section|||Probability of Event Free||90% Confidence Interval|Number
2746087|NCT00908947|Secondary|Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.|Freedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure.|12-, 24-, and 36-months post-index procedure||||Probability of Event Free||90% Confidence Interval|Number
2746088|NCT00908947|Secondary|Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure|Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of < 2.0, <2.5, and < 3.0.|12, 24, and 36 months Post Index Procedure|Eighteen (18) patients were enrolled with lesions >160mm, therefore N=18. However, 15 patients had available data for analysis at 12, 24 and 36 months, therefore n=15.|||Probability of Event Free||90% Confidence Interval|Number
2746089|NCT00908947|Secondary|Freedom From Fracture at 12 and 24-Months Post-Index Procedure|Freedom from Fracture (FFF) at 12- and 24-months post-index procedure.|12- and 24-months post-index procedure|The results presented in this analysis include active patients that had available x-ray images appropriate for analysis by the core-lab at follow-up time (12 and 24 months). Therefore n=166 instead of N=173.|||Probability of Event Free||90% Confidence Interval|Number
2746090|NCT00908947|Secondary|Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.|Primary Effectiveness (Device Success) of Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.|12-months Post-Index Procedure|Target lesions >160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.|||Probability Device Success||90% Confidence Interval|Number
2746091|NCT00908947|Secondary|Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.|• Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.|30-days and 12-months Post -Index Procedure|Target lesions >160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.|||Probability of Event Free||90% Confidence Interval|Number
2746092|NCT00908947|Secondary|Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.|Target Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel.|12-months post-index procedure||||Probability of Event Free||95% Confidence Interval|Number
2746149|NCT00908544|Secondary|Median Change in CD4+T Cells Over Time|Median Change from baseline (IQR, interquartile range) in CD4+T cells/µl.|Change from baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||cells/µl||Inter-Quartile Range|Median
2746093|NCT00908947|Primary|Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure|"The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness.~Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length.~Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS)."|At time of procedure (acute) and 12-months post-index procedure (Chronic)||||Probability of effectiveness||95% Confidence Interval|Number
2746094|NCT00908947|Primary|Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.|Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.|30-days and 12-months|One subject expired on day 22 post-index procedure due to pneumonia (total N = 173, as per Participant Flow). The event was unrelated to study device but possibly related to procedure as adjudicated by the Clinical Events Committee (CEC).|||Probability of Event Free||95% Confidence Interval|Number
2746095|NCT00908908|Primary|Pharmacokinetics AUC (0-t) for Eribulin in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population|||ng eq*hr/mL/mg||Standard Deviation|Mean
2746096|NCT00908908|Primary|Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population|||ng eq*hr/mL/mg||Standard Deviation|Mean
2746097|NCT00908908|Primary|Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.||312 hours postdose|Pharmacokinetic Population|||percent recovery||Standard Deviation|Mean
2746098|NCT00908895|Secondary|Range of Movement of Wrist|"Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.~Motion is described as a percentage of the opposite side."|6 months||||Percentage of opposite side||95% Confidence Interval|Mean
2746099|NCT00908895|Primary|The Grip Strength|Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.|6 months|No participant changed to the other group. Patients lost or with complications were not analyzed|||Percentage of opposite side||95% Confidence Interval|Mean
2746100|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 6-month follow-up period|These numbers represent those who completed the survey.|||units on a scale||Standard Deviation|Mean
2746101|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 90-session intervention period|These numbers represent those that completed the survey.|||units on a scale||Standard Deviation|Mean
2746102|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At the end of the 6-month follow-up period|These numbers represent those that completed the survey.|||units on a scale||Standard Deviation|Mean
2746103|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At end of 90-session intervention period|These numbers represent those that completed the survey.|||units on a scale||Standard Deviation|Mean
2746104|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Are you currently a smoker?~Yes, I currently smoke (move to For Smokers Only section)~No, I quit within the last 6 months (ACTION STAGE)~No, I quit more than 6 months ago (MAINTENANCE STAGE)~No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?~(For smokers only) Are you seriously thinking of quitting smoking?~Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)~Yes, within the next 6 months (CONTEMPLATION STAGE)~No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During the 6-month follow-up period||||participants|||Number
2746105|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During the 6-month follow-up period||||participants|||Number
2746106|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During the 6-month follow-up period||||participants|||Number
2746107|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During 90-session intervention period||||participants|||Number
2746108|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Transtheoretical Model of Change questionnaire:~Are you currently a smoker?~Yes, I currently smoke (move to For Smokers Only section)~No, I quit within the last 6 months (ACTION STAGE)~No, I quit more than 6 months ago (MAINTENANCE STAGE)~No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?~(For smokers only) Are you seriously thinking of quitting smoking?~Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)~Yes, within the next 6 months (CONTEMPLATION STAGE)~No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During 90-session intervention period||||participants|||Number
2746109|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During 90-session intervention period||||participants|||Number
2746128|NCT00908596|Secondary|"Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Characterization"|The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
2746110|NCT00908830|Secondary|Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression.|"Inter- and intra-patient variability will be calculated by the coefficients of variation (CV) of the MPA AUC (mg*h/L).~To analyze the intra- and interindividual variability, the coefficient of variation (CV) was calculated by dividing the standard deviation by the mean of the PK parameters from the 3 PK visits and the 5 study patients in each group, respectively. Inter-individual CVs presented are only comparing within the individuals per arm, not across or between arms."|0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose||||percent CV||Standard Deviation|Mean
2746111|NCT00908830|Primary|Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients.|The AUC is the area under the concentration-time curve from time 0 to 12 hours. The AUC is measured in units of micrograms of mycophenolic acid (MPA) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg*h/L) and in units of micrograms of mycophenolic acid glucuronide (MPAG) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg*h/L). Apparent oral clearance (CL/F) was calculated by dose/AUC0-12.|0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose||||mg*h/L||Standard Error|Mean
2746112|NCT00908791|Secondary|Safety of Short Term Treatment With 7.5 Gram CLA Per Day.||2 months|Reported toxicities deemed|||participants|||Number
2746113|NCT00908791|Secondary|Number of Participants With Measurable Concentration of the Circulating Plasma Free CLA Isomers c9t11 and t10c12 Matched to Ki-67 Expression||Pre-CLA treatment and up to 2 years Post-CLA treatment||||Participants|||Count of Participants
2746114|NCT00908791|Secondary|Number of Participants With Measurable Concentration of the Circulating Plasma Free CLA Isomers c9,t11 and t10,c12 Matched to Spot 14 Expression.||Pre-CLA treatment and up to 2 years Post-CLA treatment||||Participants|||Count of Participants
2746115|NCT00908791|Secondary|Assess Tumor Cell Apoptosis by Immunostaining for Cleaved Caspase 3 Pre and Post CLA|To determine whether ≥ 10 days of CLA consumption impacts the status of tumor cell apoptosis by measuring the presence of immunostaining for cleaved caspase 3.|Pre-CLA treatment and up to 2 years Post-CLA treatment||||stained cells/field||Standard Deviation|Mean
2746116|NCT00908791|Secondary|Number of Participants With Ki67 Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry|To determine whether ≥ 10 days of CLA consumption impacts the status of tumor proliferation by calculating the percentage of cells expressing Ki67.|Pre-CLA treatment and up to 2 years Post-CLA treatment||||Participants|||Count of Participants
2746117|NCT00908791|Secondary|Number of Participants With LPL Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2|To determine whether ≥ 10 days of CLA consumption suppresses LPL expression in brest cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).|Pre-CLA treatment and up to 2 years Post-CLA treatment||||participants|||Number
2746118|NCT00908791|Secondary|Number of Participants With FASN Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2|To determine whether ≥ 10 days of CLA consumption suppresses FASN expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).|Pre-CLA treatment and up to 2 years Post-CLA treatment||||participants|||Number
2746119|NCT00908791|Primary|Number of Participants With Spot 14 Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2|To determine whether ≥ 10 days of CLA consumption suppresses Spot 14 expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).|Up to 28 days||||participants|||Number
2746120|NCT00908687|Other Pre-specified|Cross-clade HI Antibody Titer Measurement: Compare the Heterologous HI Antibody Responses to the A/Indonesia/05/2005 (Clade 2.1) Strain of the H5N1 Virus.||6 months|||||||
2746121|NCT00908687|Other Pre-specified|Adjuvanticity Evaluation: Compare HI Immune Responses Achieved by Antigen and Adjuvant Combinations With Antigen Alone Groups.||6 months|||||||
2746122|NCT00908687|Secondary|Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity|"The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%~The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%~Geometric mean titer (GMT) fold increase > 2.5"|Day 28|||||||
2746123|NCT00908687|Secondary|Safety of a 100μg LT Patch||6 months|||||||
2746124|NCT00908687|Secondary|Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch||6 months|||||||
2746125|NCT00908687|Primary|Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.|Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40.|Day 28|Primary Immunogenicity Evaluable Population (PIEP): all subjects who were consented, randomized, received the assigned treatment, had HI assay results at all the following time points: baseline (Day 0), Day 21 and Day 28, and did not have any major protocol deviations|||percentage of subjects||95% Confidence Interval|Number
2746126|NCT00908648|Secondary|Detection of Flat and/or Depressed Adenomas|number of patients with at least 1 flat and/or depressed adenoma|duration of colonoscopy procedure||||participants|||Number
2746127|NCT00908648|Primary|Adenoma Detection|Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization|duration of colonoscopy procedure||||participants|||Number
2746129|NCT00908596|Secondary|"Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Delineation"|The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
2746130|NCT00908596|Secondary|"Number of Participants With Excellent / Good / Adequate / Insufficient Scores for Lesion Detection"|The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
2746131|NCT00908596|Secondary|Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)|The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
2746132|NCT00908596|Secondary|Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score|Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
2746133|NCT00908596|Primary|Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information|A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
2746134|NCT00908583|Secondary|Acute Rejection Rate|Acute rejection rate at 6 months of all desensitized and transplanted patients|6 months post transplant|One graft loss occurred due to graft thrombosis within 24 hours (due to unrecognized hypercoagulability disorder without AMR). Two patients were transplanted at other centers and data was not available. This dropped the number of analyzed patients to 16 from 19.|||participants|||Number
2746135|NCT00908583|Secondary|Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%|Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%.|46 days||||participants|||Number
2746136|NCT00908583|Primary|Number of Living Donor Transplant Candidates That Are Transplanted|Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted|1 year post baseline||||participants|||Number
2746137|NCT00908583|Secondary|Overall Safety of Bortezomib|Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD).|Study Day 62||||participants|||Number
2746138|NCT00908544|Secondary|Absolute CD8+CD38+T Cells|Median CD8+CD38+T cells/µl at baseline (IQR, interquartile range) and during follow-up|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||cells/µl||Inter-Quartile Range|Median
2746139|NCT00908544|Secondary|Absolute CD8+T Cells|Median CD8+T cells/µl at baseline (IQR, interquartile range) and during follow-up|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||cells/µl||Inter-Quartile Range|Median
2746140|NCT00908544|Secondary|CD4+/CD8+ Ratio|Median CD4+/CD8+ ratio at baseline (IQR, interquartile range) and during follow-up|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||ratio||Inter-Quartile Range|Median
2746141|NCT00908544|Secondary|Relative CD4+T Cells|Median relative CD4+T cells/µl at baseline (IQR, interquartile range) and during follow-up|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||percentage of Lymphocytes||Inter-Quartile Range|Median
2746142|NCT00908544|Secondary|Absolute CD4+T Cells|Median CD4+T cells/µl at baseline (IQR, interquartile range) and during follow-up|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||cells/µl||Inter-Quartile Range|Median
2746143|NCT00908544|Secondary|Absolute HIV DNA in CD4+T Cells|Absolute HIV DNA in CD4+T cells from baseline (Median; IQR, interquartile range), to quantify the cell-associated latently infected reservoir size by visit and treatment Group.|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||log copies/10^6 CD4+T cells||Inter-Quartile Range|Median
2746144|NCT00908544|Secondary|Absolute HIV DNA in PBMC|Absolute HIV DNA in PBMC (= peripheral blood mononuclear cells) from baseline (Median; IQR, interquartile range), to quantify the cell-associated latently infected reservoir size by visit and treatment Group.|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||log copies/10^6 PBMC||Inter-Quartile Range|Median
2746145|NCT00908544|Secondary|Median Change in CD8+CD38+T Cells Over Time|Median Change from baseline (IQR, interquartile range) in CD8+CD38+T cells/µl.|Change from baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||cells/µl||Inter-Quartile Range|Median
2746146|NCT00908544|Secondary|Median Change in CD8+T Cells Over Time|Median Change from baseline (IQR, interquartile range) in CD8+T cells/µl.|Change from baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||cells/µl||Inter-Quartile Range|Median
2746147|NCT00908544|Secondary|Median Change in CD4+/CD8+ Ratio Over Time|Median change in CD4+/ CD8+ ratio at baseline (IQR, interquartile range) and during follow-up|Change form Baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||ratio||Inter-Quartile Range|Median
2746150|NCT00908544|Secondary|Median Change in HIV DNA in CD4+T Cells Over Time|Median Change from baseline (IQR, interquartile range) in HIV DNA in CD4+T cells, to evaluate the decay rates of latently infected cell reservoir.|Change from baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||log copies/10^6 CD4+T cells||Inter-Quartile Range|Median
2746151|NCT00908544|Secondary|Median Change in HIV DNA in PBMC Over Time|Median Change from baseline (IQR, interquartile range) in HIV DNA copies/10exp6 PBMC (= peripheral blood mononuclear cells), to evaluate the decay rates of latently infected cell reservoir.|Change from baseline at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||log copies/10^6 PBMC||Inter-Quartile Range|Median
2746152|NCT00908544|Secondary|HIV RNA <50 Copies/ml (Proportion)|Percentage of patients with Plasma HIV RNA <50 copies/ml at baseline and during follow-up|Baseline and at months 1, 3, 6 and then every 6 months until month 84|Data of 42 patients (Efficacy set)|||Participants|||Count of Participants
2746153|NCT00908544|Secondary|Mean Change in HIV DNA in CD4+T Cells (Month 36 and Month 84)|Mean change (CI=95% Confidence Intervall) in HIV DNA copies/10exp6 CD4+T cells from baseline, to evaluate the decay rates of latently infected cell reservoir.|Change from baseline at months 36 and 84|Data of 42 patients (Efficacy set) at month 36 and 84|||log copies/10^6 PBMC||95% Confidence Interval|Mean
2746154|NCT00908544|Secondary|Mean Change in HIV DNA in PBMC (Month 36 and Month 84)|Mean change (CI=95% Confidence Intervall) in HIV DNA copies/10exp6 PBMC (= peripheral blood mononuclear cells) from baseline, to evaluate the decay rates of latently infected cell reservoir.|Change from baseline at months 36 and 84|Data of 42 patients (Efficacy set) at month 36 and 84|||log copies/10^6 PBMC||95% Confidence Interval|Mean
2746155|NCT00908544|Primary|Combined Endpoint Including HIV RNA and HIV DNA|The primary outcome measure (i.e. achievement of 'eradication') is a combined endpoint including cell-associated proviral DNA and plasma HIV RNA and is defined as undetectable cell-associated HIV DNA (copies per 10exp6 PBMC (peripheral blood mononuclear cells) and per 10exp6 CD4 cells) for at least 2 years (measurement by the French ANRS Group) combined with plasma viral load < 50 copies/ml for at least 5 years and undetectable plasma viral load (HIV RNA < 1 copy/ml, 1-copy assay) for at least 2 years.|Screening, month -3 (= pre-baseline only for CHI-patients), baseline, months 1, 3, 6 and then every 6 months until month 84|The efficacy dataset is based on patients who were enrolled in the study, received at least one dose of study drugs and met the inclusion criteria (N=42 patients; efficacy population).|||Participants|||Count of Participants
2746156|NCT00908466|Secondary|Change From Baseline VA by ETDRS||6 and 12 months|||||||
2746157|NCT00908466|Primary|Number of Participants With at Least 2-step Decrease in Vitreous Haze (VH)|Vitreous Haze is calculated using a 9 step photographic haze in uveitis patients using fundus photograph|6 months||||participants|||Number
2746158|NCT00908388|Primary|Exclusion of Primary Entry Tear|Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery|1 month||||participants|||Number
2746159|NCT00908388|Secondary|Additional Dissection Based Intervention Rate|Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.|Last available follow-up through 5 years||||participants|||Number
2746160|NCT00908388|Secondary|Aortic Rupture|Number of participants with thoracic aortic rupture|Last available follow-up through 5 years||||participants|||Number
2746161|NCT00908388|Secondary|False Lumen Thrombosis|Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.|Last available follow-up through 5 years|Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis|||participants|||Number
2746162|NCT00908388|Primary|All-cause Mortality Incidence Through 30 Days Post-treatment||30 Days Post-Treatment|All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.|||participants|||Number
2746163|NCT00908375|Secondary|Oswestry Disability Questionnaires|"Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks."|3 weeks||||percent disability||Full Range|Median
2746164|NCT00908375|Secondary|Patient's Global Impression of Change at 3 Weeks|"Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse"|3 weeks||||units on a scale||Full Range|Median
2746165|NCT00908375|Primary|Pain Scores (NRS) at 3-weeks|"Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.~."|3 weeks||||units on a scale||Full Range|Median
2746166|NCT00908349|Primary|Percent Change in Seizure Rate|Measured as change from baseline to end of study|one year||||percentage of change in seizure rate||Full Range|Median
2746167|NCT00908310|Primary|Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).|Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.|Greater than or equal to 7 days post contrast administration.|Incidence of Nephrogenic Systemic Fibrosis (NSF)|||percentage of subjects||95% Confidence Interval|Number
2746180|NCT00908115|Primary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the beginning of the study and during the entire study period (up to 6 years)||||Subjects|||Number
2775157|NCT00706238|Secondary|Documentation of Any Toxicity.||During the entire study, up to 2.5 years per patient|As the study was terminated before the end of recruitment, data was not collected.||||||
2746168|NCT00908232|Secondary|Overall Survival|Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
2746169|NCT00908232|Secondary|One Year Survival|Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||percent probability||95% Confidence Interval|Number
2746170|NCT00908232|Secondary|Time to Progression|Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), Median Follow-up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
2746171|NCT00908232|Secondary|Progression Free Survival|"Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR). Median Follow-Up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
2746172|NCT00908232|Secondary|Median Time to First Confirmed Response|Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
2746173|NCT00908232|Primary|Overall Best Confirmed Response|Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.|||number of participants|||Number
2746174|NCT00908141|Primary|Prostate Specific Antigen (PSA) Response|The number of patients with PSA modulation defined as PSA decline of at least 50%|post treatment at 9 weeks||||participants|||Number
2746175|NCT00908128|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
2746176|NCT00908128|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
2746177|NCT00908128|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
2746178|NCT00908115|Primary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) following vaccination.||||Subjects|||Number
2746179|NCT00908115|Primary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.|During the 4-week follow-up period after each dose|Analysis was performed on the subjects who received the considered dose.|||Subjects|||Number
2746692|NCT00904371|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)|||Participants|||Number
2746181|NCT00908076|Primary|Change From Baseline to End of Study|Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student's t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.|Baseline to end of study|"A marked or very marked clinical global improvement.~Ondo WG et al. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology 2012 May 22; 78:1650. - See more at: http://www.jwatch.org/jn201205290000006/2012/05/29/lubiprostone-constipation-parkinson-disease#sthash.ggWrS7Vq.dpuf"|||Percentage of participants|||Number
2746182|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|BL, 3 and 6mo Follow-up of Part 2/3|Safety Population: all subjects who have received at least one dose of the investigational product during Part 2/3 were analyzed.|||Participants|||Number
2746183|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|Baseline, 3and 6-mo Follow-up of Part 1|Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.|||Participants|||Number
2746184|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 31 of Part2/3|Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed|||Participants|||Number
2746185|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 7 of Part 2|Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.|||Participants|||Number
2746186|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 24 of Part1|Safety Population: all participants who received at least one dose of the investigational product during Part 1 were analyzed.|||Participants|||Number
2746187|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 2/3 up to Study Week 31|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population|||Participants|||Number
2746195|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Baseline through Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population .|||Breaths per min||Standard Deviation|Mean
2746693|NCT00904371|Secondary|Number of Patients With Adverse Events (AE)||4-10 months|Treated patients|||Participants|||Number
2746188|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.|Baseline and Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population|||Participants|||Number
2746189|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.|||Participants|||Number
2746190|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.|||Beats per minute||Standard Deviation|Mean
2746191|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Beats per minute||Standard Deviation|Mean
2746192|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline (MPB) visit included any scheduled and unscheduled post-Baseline assessment..|From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population|||Beats per minute||Standard Deviation|Mean
2746193|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Breaths per minute||Standard Deviation|Mean
2746194|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population|||Breaths per min||Standard Deviation|Mean
2746196|NCT00908037|Secondary|Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3|Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: <85, 85-115, >115; for Cohort 2: <85, 85-120,>120; and Cohort 3: <95, 95-135, >135. RR for DBP (mmHg) for Cohort 1: <45, 45-70,>70; for Cohort 2: <50, 50-75, >75; and Cohort 3: <55, 55-85, >85.|From Baseline through Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2746197|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline and post-Baseline up to Study Week 31 of Part 2/3|Safety Population, only those participants enrolled during Part 2/3 were analyzed.|||Participants|||Number
2746198|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline and post-Baseline up to Study Week 7 of Part 2|Safety Population, only those participants enrolled during Part 2 were analyzed.|||Participants|||Number
2746199|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline up to Study Week 24 of Part 1|Safety Population, only those participants enrolled during Part 1 were analyzed.|||Participants|||Number
2746200|NCT00908037|Secondary|Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute [ ml/min]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles [mg/mmol]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2746201|NCT00908037|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter [TI/L]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter [GI/L]), mean platelet volume (MPV, RR: 4 - 14 femotoliter [fL]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2746208|NCT00908037|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.|||Participants|||Number
2746202|NCT00908037|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Clinical chemistry parameters included: aspartate amino transferase (AST, reference range [RR]: 0-38 International Units per Liter [IU/L]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles [umol]/L), albumin grams [g/L], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles [mmol]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2746203|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline of Part 2/3 through Follow-up|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2746204|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline through Week 7 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2746205|NCT00908037|Secondary|Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|From Baseline to end of treatment up to Study Week 31|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Score on scale||Standard Deviation|Mean
2746206|NCT00908037|Secondary|Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline and Week 6 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Score on scale||Standard Deviation|Mean
2746207|NCT00908037|Secondary|Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline, Week 6, Week 12, and Week 24 of Part 1|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Score on scale||Standard Deviation|Mean
2746209|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3|Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.|From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.|||Percentage of Participants|||Number
2746210|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.|The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day.|From Baseline up to Week 24+ 1 day of Part 1|ITT Population, only those participants enrolled during Part 1 were analyzed.|||Percentage of Participants|||Number
2746211|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline up to Study Week 31|ITT Population only those participants enrolled in Part 2/3 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2/3.|||Weeks||Full Range|Median
2746212|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count|From Baseline through Week 7 of Part 2|ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.|||Weeks||Full Range|Median
2746213|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3|The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
2746214|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3|The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||hour (hr)||Full Range|Median
2746228|NCT00907881|Secondary|Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12|Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.|Baseline and Week 12|All enrolled participants with available data at both Baseline and Week 12.|||Correlation coefficient|||Number
2746229|NCT00907881|Secondary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)|Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12||||Correlation coefficient|||Number
2746215|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.|The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
2746216|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.|The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||Microgram*hour per milliliter (ug*h/mL)||95% Confidence Interval|Geometric Mean
2746217|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|Part 2/3 up to Study Week 31|ITT Population. Only evaluable participants were included for this analysis, where participants with a baseline platelet count >10 Gi/L was considered as evaluable.|||Percentage of Participants|||Number
2746218|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.|From Day 1 of treatment up to Week 24 of Part 1|ITT Population only those participants enrolled during Part 1 were analyzed.|||Percentage of Participants|||Number
2746219|NCT00908037|Secondary|Weighted Mean Platelet Count|The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.|Baseline and Day 43 of Part 2|ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis|||Gi/L||Standard Deviation|Mean
2746220|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)|Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count >=50 Gi/L during treatment with eltrombopag in >= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.|Between Day 15 and Day 43 of Part 2|Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.|||Percentage of Participants|||Number
2746221|NCT00908037|Primary|Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)|Participants who achieved a platelet count >=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.|From Day 8 up to Day 43 of Part 2|Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count >10Gi/L was considered as evaluable.|||Percentage of Participants|||Number
2746222|NCT00908011|Secondary|Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN||3 months from baseline|||||||
2746223|NCT00908011|Secondary|Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein||3 months from baseline|||||||
2746224|NCT00908011|Primary|The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.||3 months from baseline||||mmol/L||Standard Deviation|Mean
2746225|NCT00907907|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
2746226|NCT00907907|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
2746227|NCT00907907|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
2746230|NCT00907881|Secondary|Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)|Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.|||Score on a scale||Standard Deviation|Mean
2746231|NCT00907881|Primary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores|Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.|||Correlation coefficient||95% Confidence Interval|Number
2746232|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 14|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 21 and 20 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ).|||hours||Standard Deviation|Mean
2746233|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 5 and 6 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).|||ng*hr/mL||Standard Deviation|Mean
2746234|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 23 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ) before the 24-hour dosing interval was complete.|||ng*hr/mL||Standard Deviation|Mean
2746235|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 and 5 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).|||hours||Standard Deviation|Mean
2746236|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.|||hours||Standard Deviation|Mean
2746237|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).|||ng/mL||Standard Deviation|Mean
2746238|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.|||ng/mL||Standard Deviation|Mean
2746239|NCT00907803|Primary|Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.|Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.|Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose|As per protocol. During the study, a total of 6 withdrawals occurred. These were due to adverse events (2) and consent withdrawal (1) in the 400 mg group, and subject request (1), lost to follow-up (1) and protocol violation (1) in the 600 mg group.|||Participants|||Number
2746240|NCT00907777|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.|Throughout the entire study period (approximately 1 month per subject)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Participants|||Count of Participants
2746241|NCT00907777|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within 31 days (Day 0-30) post-additional vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Participants|||Count of Participants
2775158|NCT00706238|Secondary|Progression-free Survival After Initial SPD.||At the time of analysis.|As the study was terminated before the end of recruitment, data was not collected.||||||
2746242|NCT00907777|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Participants|||Count of Participants
2746243|NCT00907777|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited general symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Participants|||Count of Participants
2746244|NCT00907777|Secondary|Anti-protein D Antibody Concentrations|The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2746245|NCT00907777|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2746246|NCT00907777|Secondary|Cross-reactive Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2746247|NCT00907777|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2746248|NCT00907777|Primary|Vaccine Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2746249|NCT00907738|Primary|Percent of Participants With a Serious Drug-related Adverse Event (AE)|"A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.~A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug."|From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)||||percent of participants|||Number
2746250|NCT00907621|Secondary|Parents Evaluation of Benefit to the Child.|"Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well.~The numbers are the actual evaluations on the time specified."|5 days, 1 , and 4 weeks after the first treatment|The differences in numbers on parents evaluation of the childs condition (37 and 38) is due to one location assistant not reporting back on these results. Thus the number of interviews, 84, and secondary outcome data is not consistent with the numbers in the flow diagram.|||units on a scale||Standard Deviation|Mean
2746251|NCT00907621|Primary|Change in Crying Time Per 24 Hour Period.|Crying time per 24 hour period at baseline and post treatment|6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.||||minutes crying time pr 24 hour||95% Confidence Interval|Mean
2746252|NCT00907517|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.|Up to 135 days|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2746274|NCT00907335|Secondary|Measurement of Success 2|Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12||||Participants|||Number
2746253|NCT00907517|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.|Up to 45 days after last dose of study treatment (Up to 180 days)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2746254|NCT00907517|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.|Throughout Cycle 1 (Up to 6 weeks)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2746255|NCT00907478|Secondary|Number of Participants Who Developed Antibodies or Neutralizing Antibodies to Romiplostim or to Endogenous Thrombopoietin|"Two validated assays were used to test for antibodies to romiplostim, the thrombopoietin-mimetic peptide component of romiplostim (TMP) and to endogenous thrombopoietin (TPO). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies.~Persistent antibodies were those positive at the last timepoint tested and transient are defined as positive post-dose but negative at the last time point tested."|Every 24 weeks and at the end of study visit (4 weeks or 12 weeks after study drug discontinuation).|All participants who received at least one dose of romiplostim.|||participants|||Number
2746256|NCT00907478|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant that did not necessarily have a causal relationship with this treatment, or any such occurrence or worsening of a pre-existing medical condition from the first dose of investigational product through the last study visit. A serious adverse event is defined as an AE that is fatal or life threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. The relationship of each AE to the study drug was assessed by the investigator. The severity of each AE was graded using using CTCAE 3.0; For any AEs not listed in CTCAE, the Amgen Standard Severity Scoring System was used: 1: Mild- Aware of sign or symptom, but easily tolerated; 2 Moderate- Discomfort enough to cause interference with usual activity; 3: Severe- Incapacitating with inability to work or do usual activity; 4: Life-threatening; 5: Fatal.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim|||participants|||Number
2746257|NCT00907478|Secondary|Percentage of Participants With CTCAE Grade ≥ 2 Shift in Anemia or Neutropenia|Anemia was identified by laboratory values with hemoglobin < the lower limit of normal (LLN) or the Medical Dictionary for Regulatory Activities (MedDRA) terms prespecified by the sponsor. Neutropenia was identified by laboratory values with absolute neutrophil count <1.8x10^9/L or the MedDRA terms pre-specified by the sponsor. Severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, based on the following: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim|||percentage of participants||95% Confidence Interval|Number
2746258|NCT00907478|Secondary|Number of Participants With Improvement of Reticulin to a Grade of ≤ 2 for Participants Who Developed Grade 3 Reticulin|The number of participants who had any improvement of reticulin to a grade of ≤ 2 for participants who developed grade 3 reticulin after initial exposure to romiplostim as measured by the modified Bauermeister grading scale. The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|12 weeks after romiplostim discontinuation|Participants with Grade 3 reticulin at Year 1, 2 or 3 and who had a follow-up bone marrow biopsy 12 weeks after romiplostim discontinuation. Two participants with grade 3 reticulin did not have a bone marrow biopsy performed 12 weeks after romiploastim discontinuation.|||participants|||Number
2746259|NCT00907478|Secondary|Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals|A clinically relevant change in QTc (Fridericia) interval is defined as an absolute QTc interval >500 ms or a QTc Interval increase from Baseline >60 ms post romiplostim exposure. 12-lead electrocardiograms (ECG) were performed in triplicate at Baseline, Week 3 and Week 12; the average of of the 3 values at each assessment was used.|Baseline, Week 3 and Week 12|All participants who received at least one dose of romiplostim.|||percentage of participants||95% Confidence Interval|Number
2746275|NCT00907335|Secondary|Measurement of Success 1|Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12||||Participants|||Number
2775159|NCT00706238|Secondary|Progression-free Survival.||At the time of analysis.|As the study was terminated before the end of recruitment, data was not collected.||||||
2746260|NCT00907478|Secondary|Percentage of Participants Who Developed an Increased Modified Bauermeister Grade|Increased modified Bauermeister grade refers to an increase by ≥ 2 severity grades or an increase to grade 4 (ie, grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|At Year 1, Year 2, or Year 3 post romiplostim exposure|Participants who had evaluable reticulin silver stain results|||percentage of participants||95% Confidence Interval|Number
2746261|NCT00907478|Secondary|Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3|The number of participants with collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in participants who developed collagen fibrosis at Years 1, 2, or 3 after initial exposure of romiplostim, assessed by the central laboratory using the modified Bauermeister grading scale.|12 weeks after romiplostim discontinuation|Participants with collagen fibrosis at Year 1, 2 or 3 and with available trichome staining results 12 weeks after study drug discontinuation. One participant with collagen fibrosis refused the follow-up bone marrow biopsy.|||participants|||Number
2746262|NCT00907478|Primary|Percentage of Participants With Collagen Fibrosis|The percentage of participants who developed collagen fibrosis as evidenced by trichrome staining. Bone marrow biopsy samples were assessed using the modified Bauermeister grading scale by a central laboratory.|At Years 1, 2 or 3 after initial exposure of romiplostim|Participants who had evaluable trichrome stain results|||percentage of participants||95% Confidence Interval|Number
2746263|NCT00907426|Other Pre-specified|Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4|Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Percentage of Participants|||Number
2746264|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Darkness at Month 4|Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Eyelash Intensity Units||Standard Deviation|Mean
2746265|NCT00907426|Secondary|Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4|Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Millimeters squared (mm^2)||Standard Deviation|Mean
2746266|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Length at Month 4|Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Millimeters (mm)||Standard Deviation|Mean
2746267|NCT00907426|Primary|Percentage of Treatment Responders at Month 4|Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.|Month 4|Intent-to-Treat: All randomized subjects|||Percentage of Subjects|||Number
2746268|NCT00907374|Secondary|Endothelial Dysfunction|Post hyperemia increase in blood flow - fold increase from before and after occluding BP; values are mean of all participants in 6-36 months of study period.|6 to 36 months|complerters|||Fold increase||Standard Deviation|Mean
2746269|NCT00907374|Secondary|Carotid Artery Intima Thickness|Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study|6 to 36 months|Completers|||mm||Standard Deviation|Mean
2746270|NCT00907374|Secondary|Estimated Glomerular Filtration Rate|This is an average for all participants during the 3-36 month study period|3 to 36 months|Completers|||ml/min/1.73 meters squared||Standard Deviation|Mean
2746271|NCT00907374|Primary|Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio|Average of ratio for all participants during the 3-36 months of the study|3 to 36 months||||Ratio||Standard Deviation|Mean
2746272|NCT00907335|Secondary|Global Assessment|Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.|Baseline to Week 12||||Participants|||Number
2746273|NCT00907335|Secondary|Measurement of Success 3|"Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of Excellent or Good scores."|Week 12||||Participants|||Number
2746276|NCT00907335|Secondary|Change From Baseline in Lesion Counts|Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12||||Lesions||Standard Error|Least Squares Mean
2746277|NCT00907335|Primary|Change From Baseline in Total Non-inflammatory Lesion Count|Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12||||Lesions||Standard Error|Least Squares Mean
2746278|NCT00907296|Secondary|Time to Clinical Healing|"Time to clinical healing was defined as the time from the IM nailing surgery date to the first date that both the score for ability to bear weight on the fractured limb and the score for absence of pain at the fracture site were equal to 6.~The score for the ability to bear weight on the fractured limb was based on the ability to stand on affected leg without assistive device and the ability to walk without assistive device. The score ranges from 0 (unable to bear full body weight on the fractured limb) to 6 (able to bear full body weight on the fractured limb). Absence of pain at the fracture site was based on the absence of pain at the fracture site when applying direct pressure to the fracture site and applying a stress to the fracture site. The score ranges from 0 (pain without palpation at fracture site) to 6 (total absence of pain at fracture site).~Time to clinical healing was estimated using CIF; unplanned revision surgery was considered a competing risk in CIF estimate."|52 weeks|Participants who received at least 1 dose of study drug|||weeks||95% Confidence Interval|Median
2746279|NCT00907296|Secondary|Number of Participants With Unplanned Revision Surgeries||52 weeks|Participants who received at least 1 dose of study drug|||Participants|||Count of Participants
2746280|NCT00907296|Secondary|Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain|"The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2, is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical functioning domain includes 10 questions that assess limitations in physical activities because of health problems.~Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. The range of SF-36 physical functioning is 14.94 - 57.03. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement in physical functioning."|Week 8 and weeks 12, 16, 20, 24, 36, and 52|Participants who received at least 1 dose of study drug and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2746281|NCT00907296|Primary|Time to Radiographic Healing|"Time to radiographic healing was defined as the time from intramedullary (IM) nailing to the first occurrence of bridging of 3 out of 4 cortices. Radiographic fracture healing was determined by a panel of independent reviewers (orthopedic/trauma surgeons and radiologists) blinded to treatment.~The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate."|52 weeks|Participants who received at least 1 dose of study drug.|||weeks||95% Confidence Interval|Median
2746282|NCT00907257|Secondary|Measurement of Success|"Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:~0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe."|Baseline to Week 12|Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)|||Participants|||Number
2746283|NCT00907257|Secondary|Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals|Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).|Baseline to Week 12|Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).|||Lesions||Standard Error|Least Squares Mean
2746284|NCT00907257|Primary|Change From Baseline in Total Facial Acne Lesion Count|Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.|Baseline to Week 12|Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.|||Lesions||Standard Error|Least Squares Mean
2746285|NCT00907218|Secondary|Spontaneous Reports of Adverse Effects|Reports of adverse events were completed at baseline and weekly visits throughout the trial.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2746286|NCT00907218|Secondary|Vital Signs|Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2746287|NCT00907218|Secondary|ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)|The Clinical Global Impression Scale of ADHD for Improvement and Severity assess overall severity and change in severity of ADHD. The CGI-I scale is rated from 1 to 7 (1=very much improved; 7=very much worse). The CGI-S is rated from 1 to 7 as well (1=not ill; 7=extremely ill).|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2746288|NCT00907218|Secondary|Rates of Smoking Cessation|Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2775160|NCT00706238|Secondary|Time to Study Treatment Failure.||At the time of analysis.|As the study was terminated before the end of recruitment, data was not collected.||||||
2746290|NCT00907218|Primary|Time Line Follow Back of Cigarette Smoking|The reduction in cigarette smoking, defined as the change from baseline on the amount of cigarettes per day smoked (cpd), using the time-line follow back method. This method involves asking subjects to retrospectively estimate their cigarette use 7 days to 2 years prior to the interview date.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2746291|NCT00907218|Primary|The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)|The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
2746292|NCT00907153|Other Pre-specified|Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)|Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||pg/mL||95% Confidence Interval|Mean
2746293|NCT00907153|Other Pre-specified|Change From Baseline in Mean Vitamin D Binding Protein|Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2746294|NCT00907153|Other Pre-specified|Change From Baseline in Mean 25-hydroxyvitamin D|Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||ng/mL||95% Confidence Interval|Mean
2746295|NCT00907153|Secondary|Change From Baseline in Mean Free Testosterone|Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||ng/dL||95% Confidence Interval|Mean
2746296|NCT00907153|Secondary|Change From Baseline in Mean Total Testosterone|Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||ng/dL||95% Confidence Interval|Mean
2746297|NCT00907153|Secondary|Change From Baseline in Mean Triglycerides|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2746298|NCT00907153|Secondary|Change From Baseline in Mean LDL Cholesterol|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2746299|NCT00907153|Secondary|Change From Baseline in Mean HDL Cholesterol|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2746300|NCT00907153|Secondary|Change From Baseline in Mean Total Cholesterol|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2746301|NCT00907153|Secondary|Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose. HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||units on a scale||95% Confidence Interval|Mean
2746302|NCT00907153|Secondary|Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)|Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120). The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg·l^2/mmol·mU·min||95% Confidence Interval|Mean
2746303|NCT00907153|Secondary|Change From Baseline in Mean 2-hour Insulin|Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||uU/mL||95% Confidence Interval|Mean
2746304|NCT00907153|Secondary|Change From Baseline in Mean 2-hour Glucose|Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2746305|NCT00907153|Secondary|Change From Baseline in Mean Fasting Insulin|Insulin was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||uU/mL||95% Confidence Interval|Mean
2746306|NCT00907153|Secondary|Change From Baseline in Mean Fasting Glucose|Glucose was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
2775161|NCT00706238|Secondary|The Rate of Mixed Response.||At the time of analysis.|As the study was terminated before the end of recruitment, data was not collected.||||||
2746307|NCT00907153|Secondary|Change From Baseline in Mean Diastolic Blood Pressure|Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mm Hg||95% Confidence Interval|Mean
2746308|NCT00907153|Secondary|Change From Baseline in Mean Systolic Blood Pressure|Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mm Hg||95% Confidence Interval|Mean
2746309|NCT00907153|Secondary|Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)|High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/L||95% Confidence Interval|Mean
2746310|NCT00907153|Primary|Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)|Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/[log(I(0)) + log(G(0))]).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||units on a scale||95% Confidence Interval|Mean
2746311|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Stinging/Burning|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
2746312|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
2746313|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
2746314|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject's participation in the study (at his/her request or at the investigator's discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
2746315|NCT00907101|Primary|Change From Baseline in Quantitative Bacteriology Measurements at Week 4|Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².|Week 4||||log10 CFU/cm2||Standard Deviation|Mean
2746316|NCT00907088|Secondary|IDA (Hemoglobin < 110 g/L With Iron Deficiency)||Age 24 months|||||||
2746317|NCT00907088|Secondary|Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.||Age 24 months|||||||
2746318|NCT00907088|Primary|The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.||Age 24 months||||participants|||Number
2746319|NCT00906971|Primary|Retentive Fecal Incontinence.|"Retentive fecal incontinence is the lose of fecal while the patient tries to avoid the bowel movement.~The patients (or their parents) received a bowel diary and they fulfilled about frequency of episodes of retentive fecal incontinence weekly."|six weeks||||days/week||Standard Deviation|Mean
2746320|NCT00906971|Primary|Frequency of Defecation.|The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.|six weeks||||days/week||Standard Deviation|Mean
2746321|NCT00906945|Post-Hoc|Relapse Free-survival Rate||2 years|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi were evaluable for this outcome measure.|||percentage of participants|||Number
2746322|NCT00906945|Secondary|Overall Survival|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|Median follow-up was 34.6 months||||days||Full Range|Median
2746323|NCT00906945|Secondary|Time to Treatment Failure||8 days|Data was not collected for this outcome measure. It is not well defined in the literature as when to measure treatment failure. Relapse free survival is a better way to measure response duration (this outcome measure was added to the results).||||||
2746324|NCT00906945|Secondary|Time to Progression|Recurrence / morphologic relapse: Defined as reappearance of blasts in the blood or the finding of > 5% blasts in the BM, not attributable to any other cause. New dysplastic changes are considered a relapse. If there are no blasts in the peripheral blood and 5-19% blasts in the BM, the BM biopsy and aspirate should be repeated in > 1 week to confirm relapse.|2 years|Data was not collected for this outcome measure. Progression is very hard to define acute myeloid leukemia and including it as a pre-specified secondary outcome measure in the protocol was an oversight.||||||
2746325|NCT00906945|Secondary|Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity||6 hours after plerixafor|29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in CXCR4 clone 1D9||Standard Deviation|Mean
2775162|NCT00706238|Secondary|The Rate of Stable Disease.||At the time of analysis.|As the study was terminated before the end of recruitment, data was not collected.||||||
2746326|NCT00906945|Secondary|Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity||6 hours after plerixafor|29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in CXCR4 clone 1D9||Standard Deviation|Mean
2746327|NCT00906945|Secondary|Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count||6 hours after plerixafor|31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in AML blast count||Standard Deviation|Mean
2746328|NCT00906945|Secondary|Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells||6 hours after plerixafor|31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in white blood cells||Standard Deviation|Mean
2746329|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Platelet Recovery|-Platelet recovery is defined as platelets >= 100,000/mm3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR whose platelets were >=100,000/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
2746330|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Platelet Recovery|-Platelet recovery is defined as platelets >= 50,000/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had CR whose platelets were >=50,000/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
2746331|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery|-Neutrophil recovery is defined as absolute neutrophil count >= 1000/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=1000/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
2746332|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery|-Neutrophil recovery is defined as absolute neutrophil count (ANC) >= 500/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=500/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
2746333|NCT00906945|Secondary|Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency||30 days following end of treatment||||number of events|||Number
2746334|NCT00906945|Primary|Phase II: Complete Response Rate (CR+CRi)|"Morphologic complete remission (CR): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1,000/mm3, platelet count > 100,000/mm3.~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1,000/mm3 or thrombocytopenia <100,000/mm3."|45 days|Only patients enrolled in Phase 2 portion were analyzed for this outcome measure.|||percentage of participants|||Number
2746335|NCT00906945|Primary|Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC||Completion of Phase I enrollment (17 months)|Number of participants analyzed is the number of participants enrolled in the Phase I portion of the study.|||mcg/kg/day|||Number
2746336|NCT00906789|Secondary|Sensitivity and Specificity Using SoftView Software|Sensitivity and specificity were calculated using the radiologists' responses of recommendations for follow-up with CT or biopsy. Truth was whether or not the nodule identified was found to be cancer. Sensitivity is the percentage of correct identification of a positive case (a case with cancer). Specificity is the percentage of negative cases (those without cancer) that were correctly identified as not having cancer. The mean values of 15 radiologists are used.|Three days of experiment over 3-5 months, varied by participant||||percentage of cases||95% Confidence Interval|Mean
2746337|NCT00906789|Other Pre-specified|Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1|This reports the comparison of the detection of lung nodules that were proven to represent lung cancers. It compares the results of two versions of computer-aided detection software: OnGuard 1.0 from 2001 and OnGuard 5.1 from 2009. The results represent the responses of radiologists when they use one or the other types of software. To compare radiologists' results with the two types of software, the measurement analyzed was the difference in the areas under the localized receiver operating characteristic curve (LROC). The results from the 15 participating radiologists were averaged (mean value). The area under the LROC curve is a measure of the trade-offs between sensitivity and 1-specificity that occurs as the level of certainty of a positive finding changes. It is normally reported as a decimal without units. In this study dsign, a lower number indicates that the new method (OnGuard 5.1), if statistically significant, if better.|5 months|81 of the 263 radiographs contained a non-calcified nodule that had been diagnosed as lung cancer. Power calculation showed 246 patients, in a 2:1 ratio of nodule absent to present would provide 80% power to detect a difference in areas under the curve of 0.10 or greater.|||unitless|Participants|95% Confidence Interval|Mean
2746353|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746354|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2775163|NCT00706238|Primary|The Rate of Objective Clinical Response.||At the time of analysis.|As the study was terminated before the end of recruitment, data was not collected.||||||
2746338|NCT00906789|Primary|Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.|"Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer.~A larger number, if statistically significant, indicates that that method is better."|Three days of experiment over 3-5 months, varied by participant|122 subjects had cancer that potentially could be detected on their chest radiograph. Power analysis showed that sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater.|||unitless|Participants|95% Confidence Interval|Mean
2746339|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 12 months||||mm||Standard Deviation|Mean
2746340|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 6 months||||mm||Standard Deviation|Mean
2746341|NCT00906776|Secondary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 6 months||||mm||Standard Deviation|Mean
2746342|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 12 months||||millimeters||Standard Deviation|Mean
2746343|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 6 months||||mm||Standard Deviation|Mean
2746344|NCT00906776|Primary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 12 months||||millimeters||Standard Deviation|Mean
2746345|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
2746346|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
2746347|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746348|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746349|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2746350|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2746351|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
2746352|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
2746369|NCT00906425|Primary|Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)|The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.|Baseline and 6 months|ITT population|||millimeters||Standard Deviation|Mean
2746355|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2746356|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2746357|NCT00906698|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.|All patients treated in the MTD cohorts.|||weeks||Inter-Quartile Range|Median
2746358|NCT00906698|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase.|Screening and every 8 weeks after starting of treatment, up to 44 weeks.|Patients from Treated Set (TS).|||percentage change in tumour size||Standard Error|Mean
2746359|NCT00906698|Secondary|Duration of Disease Control|Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with disease control.|||days||Full Range|Median
2746360|NCT00906698|Secondary|Duration of Objective Response|The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with Objective Response.|||days||Full Range|Median
2746361|NCT00906698|Secondary|Time to Objective Response|The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from the Treated Set (TS) with objective response.|||days||Full Range|Median
2746362|NCT00906698|Secondary|Number of Patients With Disease Control (DC)|DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).|||participants|||Number
2746363|NCT00906698|Secondary|Number of Patients With Objective Response (OR)|OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).|||participants|||Number
2746364|NCT00906698|Secondary|Number of Patients With Best Overall Response|Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).|||participants|||Number
2746365|NCT00906698|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort.|28 days|Treated Set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||participants|||Number
2746366|NCT00906503|Primary|Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging|The blood glucose of all patients will be checked by accu-check before the injection of 18F-FDG. The acceptable blood glucose level will be ≤120 mg/dl. Any participant experienced elevated fasting blood glucose of more than 120 mg/dl after steroid therapy, he /she will be asked to come back to the PET center within 48 hours to check the blood glucose level. If the blood glucose level did not decline to baseline level, the participant will be asked to follow with his/her family doctor for management. Participants with history of systemic hypertension will be monitored for increased blood pressure. After 50-to-70 minutes period for FDG incorporation into presumed lesions, patient will under go a limited 18F-FDG PET/CT for the area of the interest (1-2 bed positions). PET imaging will be performed using a GE Discovery STE PET/CT system (GE Medical Systems, Milwaukee, WI).|24-48 hours||||gm/ml||Standard Deviation|Mean
2746367|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|12 months||||% of implants|||Number
2746368|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|6 months||||% of implants|||Number
2746694|NCT00904371|Secondary|Change in Heart Rate From Baseline to Study End||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status|||Beats per minute||Standard Deviation|Mean
2746370|NCT00906399|Secondary|Estimated Proportion of Participants With Sustained Disability Progression at 1 Year|Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.|1 Year|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression.|||proportion of participants|||Number
2746371|NCT00906399|Secondary|Proportion of Participants Relapsed at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.|Year 1|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal.|||proportion of participants|||Number
2746372|NCT00906399|Secondary|Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year|Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.|1 Year|ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit.|||lesions||95% Confidence Interval|Mean
2746373|NCT00906399|Primary|Annualized Relapse Rate (ARR) at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).|1 Year|Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).|||relapses per person-years||95% Confidence Interval|Number
2746374|NCT00906373|Secondary|The Number of Participants With Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)|A participant's serum sample was considered positive for antibodies against cixutumumab if it exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-cixutumumab level seen in healthy untreated individuals. A participant was considered to have an anti-cixutumumab response if there were 2 consecutive positive samples or if the final sample tested was positive.|Predose, immediately prior to the first Cycle 3 and Cycle 5 infusions (3-week cycle) and 30 days after last dose of study drug|Zero participants were analyzed. No assay was available to assess serum anti-cixutumumab antibodies.||||||
2746375|NCT00906373|Secondary|Duration of Response (DOR)|Duration of CR or PR was defined as time from first objective assessment of CR or PR until first date of PD or death from any cause. Response was defined using RECIST v 1.0 criteria. CR was defined as disappearance of all target and nontarget lesions and normalization of tumor marker levels. PR was defined as a ≥30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. PD defined as a ≥20% increase in the sum of LD of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants with no PD, who discontinued treatment for toxicity or a reason other than PD, or were lost to follow-up, were censored at date of last tumor assessment. Participants who began new anticancer therapy prior to PD or death were censored at date of last tumor assessment prior to new therapy. Participants who died or had PD after ≥2 missed tumor assessments were censored at date of last tumor assessment prior to the missed assessments|Date of first occurrence of CR or PR to first date of PD or death up to 8 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 1.|||months||95% Confidence Interval|Median
2746376|NCT00906373|Secondary|Time to Disease Progression (TTP)|TTP is defined as the time from the date of first dose of study drug until the date of objective disease progression. Participants without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and lost to follow-up were censored at the date of the last objective tumor assessment before loss to follow-up. Participants who began new anticancer therapy prior to PD or death were censored at date of last tumor assessment prior to new therapy. Participants who died or had PD after ≥2 missed tumor assessments were censored at date of last tumor assessment prior to the missed assessments.|Date of first dose of study drug to date of PD up to 12 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 14.|||months||95% Confidence Interval|Median
2746377|NCT00906373|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose of study drug to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Date of first dose of study drug to date of death up to 22 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 19.|||months||95% Confidence Interval|Median
2746447|NCT00905827|Secondary|Satisfaction With Training|Evaluation included 20 standard items assessing providers satisfaction with training, including items similar to other published satisfaction surveys. Survey items were rated using a five-point Likert scale indicating the degree to which respondents agreed or disagreed. Questions were always phrased positively so that agree or strongly agree is equivalent to a positive response.|post-training||||participants|||Number
2746378|NCT00906373|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) [Objective Response Rate (ORR)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR was defined as the disappearance of all target and nontarget lesions and the normalization of tumor marker levels. PR was defined as having a ≥30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator when calculating the response rate. Percentage of participants was calculated as: CR + PR / total number of participants in the treatment group * 100.|Date of first dose of study drug to PD up to 12 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2.|||percentage of participants||95% Confidence Interval|Number
2746379|NCT00906373|Secondary|PK: Vss Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746380|NCT00906373|Secondary|PK: AUC Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746381|NCT00906373|Secondary|PK: CL Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746382|NCT00906373|Secondary|PK: t1/2 Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746383|NCT00906373|Secondary|PK: Cmin Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746384|NCT00906373|Secondary|PK: Cmax Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746385|NCT00906373|Secondary|PK: Volume of Distribution at Steady State (Vss) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746386|NCT00906373|Secondary|PK: Area Under the Concentration Versus Time Curve (AUC) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746387|NCT00906373|Secondary|PK: Clearance (CL) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746388|NCT00906373|Secondary|PK: Half-Life (t1/2) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746389|NCT00906373|Secondary|PK: Minimum Concentration (Cmin) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746390|NCT00906373|Secondary|Pharmacokinetic (PK): Maximum Concentration (Cmax) Cycle 1||Cycle 1, Day 1: Predose, 1 hour (h), 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
2746391|NCT00906373|Secondary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|First day of treatment up to 22 months|All randomized participants who received any amount of study drug.|||Participants|||Count of Participants
2746412|NCT00906204|Primary|Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function|"The composite endpoint components and definitions are:~Fever: Body temperature ≥ 38.5˚C.~Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors.~Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for > 12 hours out of a 24 hour period.~Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia)~Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation"|During first 7 days after kidney transplantation||||participants|||Number
2746392|NCT00906373|Primary|Progression Free Survival (PFS)|PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.|Date of first dose of study drug up PD or death up to 12 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 10.|||months||95% Confidence Interval|Median
2746393|NCT00906347|Secondary|Time Elapsed From Start of Labor Augmentation to Delivery||Initiation of augmentation until delivery|Intent to treat|||minutes||Inter-Quartile Range|Median
2746394|NCT00906347|Secondary|Method of Delivery||At delivery|Intent to treat|||participants|||Number
2746395|NCT00906347|Secondary|Maternal Hypovolemia Requiring Blood Transfusion||Until hospital discharge|Intent to treat|||participants|||Number
2746396|NCT00906347|Secondary|Maternal Chorioamnionitis|Temperature 38 degrees C or higher in the absence of other sources of infection|During labor|Intent to treat|||participants|||Number
2746397|NCT00906347|Secondary|Admission of Neonatal Intensive Care Unit||Until hospital discharge|Intent to treat|||infants|||Number
2746398|NCT00906347|Secondary|Umbilical Cord Artery pH <7.1||Obtained at delivery|Intent to treat|||infants|||Number
2746399|NCT00906347|Secondary|Infant Apgar Score <4|Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.|5 minutes after delivery|Intent to treat|||infants|||Number
2746400|NCT00906347|Primary|Uterine Tachysystole|Defined as six contractions in two consecutive 10-minute periods|Up to four hours after administration of study drug|Intent to treat|||participants|||Number
2746401|NCT00906282|Secondary|Complete Resection Rate|The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).|At weeks 15-18||||percentage of patients|||Number
2746402|NCT00906282|Secondary|Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)|pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).|At 15-18 weeks|The amount of residual tumor measured in centimeters (cm).|||centimeters||Full Range|Median
2746403|NCT00906282|Secondary|Pathologic Response Rate|Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.|weeks 15 -18||||percentage of participants|||Number
2746404|NCT00906282|Secondary|Objective Tumor Response|Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]|At 6 and 12 weeks||||percentage of participants|||Number
2746405|NCT00906282|Primary|3-Year Overall Survival Rate|The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.|36 months||||percentage of participants||95% Confidence Interval|Number
2746406|NCT00906243|Primary|Phase I: Assessment of Safety and Tolerability of the Trial Regimen|"Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:~All Categories equal or greater than grade 3~Allergy/autoimmunity equal or greater than grade 2~Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0."|At Nine Weeks with Follow Up at One Year|Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.|||events|||Number
2746407|NCT00906204|Secondary|Kidney Function|Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)|12 months post-transplantation||||mL/min/1.73m^2||Standard Deviation|Mean
2746408|NCT00906204|Secondary|Incomplete Thymoglobulin Infusion||First 7 days post-transplantation||||participants|||Number
2746409|NCT00906204|Secondary|Acute Kidney Rejection|Kaplan-Meier probability estimates of rejection rates|12 months post-transplantation||||participants|||Number
2746410|NCT00906204|Secondary|Graft Survival|Kaplan-Meier estimates of graft survival probability for 12 months after transplantation|12 months post-transplantation||||participants|||Number
2746411|NCT00906204|Secondary|Patient Survival|Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.|12 months post-transplantation||||participants|||Number
2746413|NCT00906178|Secondary|Unprotected Sex at Three-month Follow-up|Ever had vaginal or anal sex without a condom in the past 90 days|3 months post-intervention|ITT--Intention to Treat|||participants|||Number
2746414|NCT00906178|Secondary|Abstinence at Three-month Follow-up|Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days|3 months post-intervention|ITT--Intention to Treat|||participants|||Number
2746415|NCT00906178|Primary|Sexual Abstinence|Not having had vaginal or anal sex in the past three months|6-months post-intervention|ITT - Intention to Treat|||participants|||Number
2746417|NCT00906165|Secondary|Soft Tissue Changes, Pink Aesthetic Score|"Soft tissue changes: the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above.~The PES index includes assessment of seven variables and each variable is measured with a 2, 1, or 0 score with 2 being the best and 0 being the poorest score. Based on its definition the PES is a cumulative score with 14 being the best and 0 the worst."|Recorded at 12 and 24 months after implant placement|Patient 218 discontinued the study after 12 months|||score on a scale||Standard Deviation|Mean
2746418|NCT00906165|Secondary|Adverse Events|Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration|From randomization to 2 years after implant placement|Patient 218 discontinued the study after 12 months|||events|||Number
2746419|NCT00906165|Secondary|Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index|Soft tissue changes: mesial and distal gingival papilla dimensions assessed by Papilla Fill Index (PFI, Jemt 1997) and the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above.|Recorded at 12 and 24 months after implant placement|Patient 218 discontinued the study after 12 months|||Participants|||Count of Participants
2746420|NCT00906165|Secondary|Gingival Recessions (REC)|The gingival recessions around the implants are recorded at the above-specified timepoints after implant placement, using a UNC-15 probe. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants)|Recorded at 16 weeks, 6, 12 and 24 months after implant placement|Patient 218 discontinued the study after 12 months|||mm||Standard Deviation|Mean
2746421|NCT00906165|Secondary|Probing Pocket Depth|The Probing Pocket Depth around the implants will be measured using a UNC-15 probe with light probing force (0.2N) at the post-implant time-points specified. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants)|Recorded at 16 weeks, 6, 12, and 24 months after implant placement|Difference of Probing Pocket Depth (PPD) between 16 weeks (loading) and 6 months, 12 months and 24 months|||mm||Standard Deviation|Mean
2746422|NCT00906165|Secondary|No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months|No of participants with prosthetic related complications and with implant failures are described after 24 months|2 years after implant placement||||participants|||Number
2746423|NCT00906165|Secondary|Number of Participants With Survival Rate of the Implants at 12 and 24 Months|The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement.|1 year and 2 years after implant placement|Survival rate of the implants at 12 months|||Participants|||Count of Participants
2746424|NCT00906165|Primary|Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment|The primary parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements at baseline and one year after implant placement. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants, on digitized standardized peri-apical x-rays using an image analysis computer program.|between baseline and one year post treatment||||mm||Standard Deviation|Mean
2746425|NCT00906087|Secondary|Myocilin Mutation Arg272Gly in Subjects|Number of subjects with Myocilin Arg272Gly|10 week study|Only 1 participant had a MYOC mutation in the 3 exons|||Participants|||Count of Participants
2746426|NCT00906087|Primary|Blood Pressure in Sitting to Supine Positions|Effect of Cosopt treatment on blood pressure changes in sitting to supine positions.|10 weeks||||mmHg||Standard Deviation|Mean
2746427|NCT00906087|Primary|Intraocular Pressure in Sitting and Supine Positions.|Effect of Cosopt treatment on intraocular pressure changes in sitting to supine positions.|10 weeks||||mmHg||Standard Deviation|Mean
2746428|NCT00906074|Secondary|Number of Participants With Antimicrobial Resistance|Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Number of participants|||Number
2746429|NCT00906074|Secondary|Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)|Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Percentage of participants|||Number
2746430|NCT00906074|Secondary|Classification of SSI Infection|Participants with organ-space or deep incisional SSI.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||participants|||Number
2746431|NCT00906074|Secondary|ASEPSIS Classification in Participants With Serious SSI|Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS). ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40).|Up to 30 days post surgery|Subset of study population with infection|||participants|||Number
2746432|NCT00906074|Secondary|Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0|Percentage of participants with NNISS score for increased preoperative risk of infection.|Baseline (pre-surgical)|Study population|||Percentage of participants|||Number
2746433|NCT00906074|Primary|Percentage of Participants With Post-surgical Drainage||Day 0 (day of surgery) up to 30 days post surgery|Study Population|||Percentage of participants|||Number
2746434|NCT00906074|Primary|Percentage of Participants Who Showed Clinical Improvement of SSI|Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Percentage of participants|||Number
2746435|NCT00906074|Primary|Percentage of Participants With Infection|Microorganism infection by bacterial type.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Percentage of participants|||Number
2746437|NCT00906074|Primary|Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty|Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.|Day 0 (day of surgery)|Study population|||Percentage of participants|||Number
2746438|NCT00906074|Primary|Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery||Day 0 (day of surgery)|Study Population|||Percentage of participants|||Number
2746439|NCT00906074|Primary|Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis||Baseline (Pre-surgical)|Study Population|||Percentage of participants|||Number
2746440|NCT00906074|Primary|Percentage of Participants With Pre-surgical Morbidities|Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia).|Baseline (Pre-surgical)|Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain|||percentage of participants|||Number
2746441|NCT00906035|Secondary|Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Reporting Blood Oxygenation.|Reporting blood oxygenation. Data could not be analyzed due to insufficient number of participants enrolled. Difficulty finding participants who fit into the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180.|Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.||||||
2746442|NCT00906035|Secondary|Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Blood Flow Reporting to Added Table.|Done by doppler ultrasound. Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180.|Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.||||||
2746443|NCT00906035|Primary|The Present Study is Designed to Explore Two Potential Mechanisms Which Have Been Linked to Dipyridamole Action on the Vessel Wall; Modulation of Vascular Eicosanoid Generation and Prevention of Oxidant Stress.|No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180|Data could not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria. Data could not be analyzed due to insufficient number of participants enrolled.||||||
2746444|NCT00905840|Secondary|Soft Tissue and Safety Assessments|"Modified Plaque Index (mPI) and modified Sulcus Bleeding Index (mSBI) according to Mombelli at al. (1987). Assessment to be perform at four sites per implant: lingual, buccal, mesial, and distal.~mPI: 0=no plaque detected, 1=plaque only recognized by running a probe across the smooth marginal surface of the implant, 2=plaque can be seen by the naked eye, 3=abundance of soft matter.~mSBI: 0=no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant, 1=isolated bleeding spot visible, 2=blood forms a confluent red line on margin, 3=heavy or profuse bleeding.~Safety evaluations including recording of all complications, adverse events (AEs), and serious adverse events SAEs). Each AE and SAE will be assessed for severity and its potential relationship to the study device."|after 12, 24, and 36 month|"The numbers represent subjects that are classified as Yes. mPI: if all 4 evaluated scores are 0 or 1, the mPI will be classified as No. If at least one score is 2 or 3, mPI will be classified as Yes.~mSBI: if all evaluated scores are 0 or 1, mSBI will be classified as No. If at least one score is 2 or 3, mSBI will be classified as Yes."|||participants|||Number
2746445|NCT00905840|Secondary|Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990|"split-mouth design~Implant success and survival rate according the definition by Buser et al. 1990 are:~Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysaesthesia~Absence of a recurrent peri-implant infection with suppuration~Absence of mobility~Absence of a continuous radiolucency around the implant~Possibility for restoration"|at 12, 24 and 36 months post surgery|The analysis was determined as Intent To Treat (ITT). The study population consisted of each randomized patient who received the device.|||implants|Participants||Number
2746446|NCT00905840|Primary|Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.|"Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material.~The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used."|12 months|The Intent To Treat (ITT) populaton consisted of all randomized patients who received implants and who underwent at least one efficacy assessment.|||mm|Participants|Full Range|Mean
2746618|NCT00904969|Primary|Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge|Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.|post discharge||||Participants|||Count of Participants
2746448|NCT00905827|Primary|Provider Self-efficacy and Beliefs About Suicidality|Assessed beliefs and confidence in managing suicidal individuals. Using a 5-point Likert scale, there were 11 items that addressed the following: competence, reactions, beliefs, motivations, and CAMS as it relates to their practice. Scores ranged from 11-55 with questions were phrased so higher scores indicated more positive views.|post-training||||units on a scale||Standard Error|Mean
2746449|NCT00905632|Secondary|Number of Participants With Discontinuations Due to AEs|Number of participants with adverse events (AEs) leading to discontinuation of trial drug|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||participants|||Number
2746450|NCT00905632|Secondary|Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG|Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.|From the start of the study to Day 30 (2 days after last dose)|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||participants|||Number
2746451|NCT00905632|Secondary|RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2746452|NCT00905632|Secondary|t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||hour||Geometric Coefficient of Variation|Geometric Mean
2746453|NCT00905632|Secondary|λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2746454|NCT00905632|Secondary|AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2746455|NCT00905632|Secondary|C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).|654 hours after drug administration on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746456|NCT00905632|Secondary|Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168|Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.|5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746457|NCT00905632|Secondary|AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168|30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2746458|NCT00905632|Secondary|Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||hour||Geometric Coefficient of Variation|Geometric Mean
2776322|NCT00697593|Primary|Urinalysis - Protein|Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine|Week 12 / Early Termination||||participants|||Number
2746459|NCT00905632|Secondary|Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746460|NCT00905632|Secondary|Plasma Concentration Time Profiles of CD 6168|Plasma concentration time profiles of CD 6168|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746461|NCT00905632|Secondary|Plasma Concentration Time Profiles of BI 207127|Plasma concentration time profiles of BI 207127|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746462|NCT00905632|Secondary|Number of Participants With Sustained Virological Response|Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC).|Until end of treatment, up to 570 days|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
2746463|NCT00905632|Secondary|Number of Participants With End of Treatment Response|Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment.|Week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
2746464|NCT00905632|Secondary|Number of Participants With Early Virological Response|Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)|Baseline and week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
2746465|NCT00905632|Secondary|Number of Participants With Rapid Virological Response|Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
2746466|NCT00905632|Secondary|Number of Participants With Virologic Response at Day 28|Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28|day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
2746467|NCT00905632|Secondary|Viral Load at Each Visit up to Day 28|Viral load (VL) (original values) at each visit up to day 28.|Baseline and days 8, 15, 22 and 28|Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value.|||IU/mL||Full Range|Median
2746468|NCT00905632|Secondary|Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline|"Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.~A negative value represents an increase in viral load, a positive value represents a decrease in viral load."|Baseline and days 1, 2, 4, 8, 15, 22 and 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28.|||IU/mL||Full Range|Median
2746469|NCT00905632|Primary|Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.|The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir.|Baseline and 4 weeks|Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy.|||Participants|||Number
2746470|NCT00905606|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746471|NCT00905606|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746472|NCT00905606|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2746473|NCT00905580|Primary|Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively||1, 6, 24 & 48 hours||||participants|||Number
2746474|NCT00905580|Secondary|Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.|we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.|3 months||||participants|||Number
2746475|NCT00905580|Primary|The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision.|1, 6, 24 & 48 hours||||participants|||Number
2746476|NCT00905580|Primary|Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable|1, 6, 24 & 48 hours||||VNRS||Inter-Quartile Range|Median
2746477|NCT00905567|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was used in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746478|NCT00905567|Primary|AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746479|NCT00905567|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in statistical analysis.|||ng/mL||Standard Deviation|Mean
2746480|NCT00905554|Secondary|Evaluation of Pain and Tolerability Scores|Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)|6-9 months||||Scores on a VAS scale||Inter-Quartile Range|Median
2746481|NCT00905554|Primary|Number of Patients Undergoing Complete Unsedated Colonoscopy||6-9 months||||participants|||Number
2746482|NCT00905515|Primary|Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine and Transforming Growth Factor Beta (TGF-B)||6 months, 1 year, 2 years, 3 years|||||||
2746483|NCT00905515|Primary|Optimal Dose/Blood Level of Prograf in Long-term Maintenance Kidney Transplant Patients||6 months, 1 year, 2 years, 3 years|||||||
2746484|NCT00905515|Primary|Renal Function in Patients Converted From Cyclosporine to Prograf||6 months, 1 year, 2 years and 3 years||||Change in serum creatinine (mg/dL)||Full Range|Mean
2746485|NCT00905489|Other Pre-specified|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit|Patients maintaining a viral load < 50 copies/mL at the last available visit|Last available visit, up to 155 weeks|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase with VL data available|||percentage of patients|||Number
2746486|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL in Optional Extension Phase|Patients maintaining a viral load < 400 copies/mL at week 24 of the Optional Extension Phase (OEP)|week 24|Full analysis set including patients with available viral load data at week 24|||percentage of patients|||Number
2746487|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Week 24 of Optional Extension Phase|Patients maintaining a viral load < 50 copies/mL at week 24 (approximately 168 days) of Optional Extension Phase (OEP).|week 24|Full analysis set including patients with available viral load data at week 24|||percentage of patients|||Number
2746488|NCT00905489|Secondary|Percentage Change From Baseline in Mean CD4+ Count|((Day 22 value-Baseline value)/Baseline value)*100. ((Week 24 value-Baseline value)/Baseline value)*100.|Baseline to day 22 and baseline to week 24|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase, and had available data at either day 22 or week 24.|||percentage change||Standard Deviation|Mean
2746489|NCT00905489|Secondary|Change From Baseline in Mean CD4+ Count (Absolute)|Change in mean CD4+ count (absolute) from baseline to Day 22 and from baseline to Week 24.|Baseline, Day 22 and week 24|PK Analysis set: This patient set includes all patients in the Full Analysis Set (FAS) that have no protocol violations excluding them from PK analysis.|||cells/mm^3||Standard Deviation|Mean
2746490|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL|Patients maintaining a viral load < 400 copies/mL at Day 22|Day 22|Full analysis set including patients with available viral load data at day 22|||percentage of patients|||Number
2746491|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL|Patients maintaining a viral load < 50 copies/mL at Day 22.|Day 22|Full analysis set including patients with available viral load data at day 22|||percentage of patients|||Number
2746492|NCT00905489|Secondary|Cavg|Average measured concentration of the Nevirapine in plasma at steady state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746493|NCT00905489|Secondary|CL/F,ss|Apparent clearance of the Nevirapine in the plasma after extravascular administration at steady-state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2746494|NCT00905489|Secondary|Tmax,ss|"Time from dosing to the maximum concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.~The standard deviation is actually the coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||hours||Standard Deviation|Mean
2746495|NCT00905489|Secondary|%PTF|Percentage peak-trough Nevirapine fluctuation, % fluctuation (degree of peak to trough fluctuation) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
2746496|NCT00905489|Secondary|Ratio Cmax,ss/Cmin,ss|Ratio of (maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ)/(minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2746497|NCT00905489|Secondary|Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746498|NCT00905489|Secondary|Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Minimum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ by nevirapine XR dose group Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 21.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2746499|NCT00905489|Secondary|AUCt,ss|"Area under the concentration-time curve of the Nevirapine (NVP) in plasma at steady state over the time dosing interval τ.~All patients received nevirapine IR for 10 days prior to collection of 12-hour Area Under the Curve (AUC) data. Then, all patients were switched to nevirapine XR for 9 days prior to collection of 24-hour AUC data. The treatments of IR and XR are summarized separately using geometric means and geometric coefficients of variation.~For NVP IR AUC measured over hours: 0,1,2,3,4,8 and 12, For NVP XR AUC measured over hours: 0,1,2,3,4,8,10,12 and 24."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng*h/ml||Geometric Coefficient of Variation|Geometric Mean
2746500|NCT00905489|Primary|Trough Cpre,N.|"Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.~The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|PK analysis set (PKS): This patient set includes all patients in the Full Analysis Set (FAS) set that have no protocol violations excluding them from PK analyses.|||(ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
2746501|NCT00905437|Secondary|Number of Participants With Neuropathic Pain|"ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. Yes response to questions 1-5 were scored as 1, while a yes response to question 6 was scored as -1. No response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported."|Day 90, Day 180 post-surgery|Data was not analyzed as the intended sample size was not met, and the reported numbers from the final set were not sufficient for a meaningful analysis.||||||
2746502|NCT00905437|Secondary|Number of Participants With Rescue Medication Usage|Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.|Day 0 to Day 6 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications.|||participants|||Number
2746503|NCT00905437|Secondary|Time to Mobilization After Surgery|Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Inter-Quartile Range|Median
2746504|NCT00905437|Secondary|Mean Anxiety Visual Analogue Scale (A-VAS)|Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.|Day 0 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||Units on a scale||Standard Error|Mean
2776323|NCT00697593|Primary|Urinalysis - pH|Urine samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||pH units||Standard Deviation|Mean
2746505|NCT00905437|Secondary|Mean Daily Sleep Interference Score|Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||Units on a scale||Standard Error|Mean
2746506|NCT00905437|Secondary|Mean Daily Pain Score|Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Day 1 to Day 7, Day 8 to Day 14 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm.|||Units on a scale||Standard Error|Mean
2746507|NCT00905437|Primary|Mean Pain on Movement Score|Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.|Every 12 hours from Day 1 to Day 5 post-surgery|Modified Intent to Treat (MITT) population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||Units on a scale||Standard Error|Mean
2746508|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2746509|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2746510|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6|BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Augmentation baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2746511|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|FAS|||Percent of participants|||Number
2746512|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation Baseline|FAS|||Percent of participants|||Number
2746513|NCT00905424|Secondary|Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Percent of participants|||Number
2746514|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2746515|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2746516|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.|||Units on a scale||Standard Error|Least Squares Mean
2746517|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
2746518|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
2746519|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6|BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
2746520|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|Primary Efficacy Analysis Set|||Percent of participants|||Number
2746521|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation baseline|Primary Efficacy Analysis Set|||Percent of participants|||Number
2746522|NCT00905424|Secondary|Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|Primary Efficacy Analysis Set|||Percent of Participants|||Number
2746523|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
2746524|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
2746525|NCT00905424|Primary|Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.|||Units on a scale||Standard Error|Least Squares Mean
2746526|NCT00905359|Secondary|Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months||14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||participants|||Number
2746527|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
2746528|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
2746529|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
2746530|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
2746531|NCT00905359|Secondary|Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points|Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||participants|||Number
2746532|NCT00905359|Secondary|Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points|The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||mm^2||Standard Deviation|Mean
2746533|NCT00905359|Secondary|Percentage of Subjects With Serious Adverse Device Effects||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).|||percentage of subjects|||Number
2746534|NCT00905359|Secondary|Number of Subjects Requiring Secondary Surgical Intervention||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).|||participants|||Number
2746619|NCT00904969|Primary|Procedural Endpoint: Rate of Foley Catheter Use - Post-operative|Number of participants requiring the use of a foley catheter who were able to void prior to discharge.|post-operative to discharge||||Participants|||Count of Participants
2746535|NCT00905359|Secondary|Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire|The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage of change from baseline||Standard Deviation|Mean
2746536|NCT00905359|Secondary|Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain|Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage of change from baseline||Standard Deviation|Mean
2746537|NCT00905359|Secondary|Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||units on a scale||Standard Deviation|Mean
2746538|NCT00905359|Secondary|Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.|14days, 6 week, 6 months, 12 months, 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage change from baseline||Standard Deviation|Mean
2746539|NCT00905359|Secondary|Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.|14 days, 6 weeks, 6 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage change from baseline||Standard Deviation|Mean
2746540|NCT00905359|Primary|Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.|1 year|Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage change from baseline||Standard Deviation|Mean
2746541|NCT00905346|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746542|NCT00905346|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746543|NCT00905346|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2746544|NCT00905307|Secondary|Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712|Efficacy-related discontinuation rate was assessed|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Percentage of participants|||Number
2746545|NCT00905307|Secondary|Response Rate at Week 6|Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impuite missing data.|||Percentage of participants|||Number
2746546|NCT00905307|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) at Week 6|The rater or investigator rated the particpant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2746620|NCT00904969|Primary|Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative|Number of participants requiring the use of a foley catheter intra-operatively.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
2746621|NCT00904969|Primary|Procedural Endpoint: Type of Anesthesia Used|Describe the type of anesthesia used.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
2746547|NCT00905307|Secondary|Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients"|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2746548|NCT00905307|Secondary|Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2746549|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2746550|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2746551|NCT00905307|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The last observation carried forward (LOCF) method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2746552|NCT00905268|Secondary|Change in Peak Workload From Baseline to Week 52|"Assessed by a modified exercise test, in a subset of patients able to undertake this.~Wpeak has been calculated from the following formula: Workload last fully completed stage + (seconds completed in last stage / 60 * (4 [if arm ergonometry] or 10 [if leg ergonometry]))."|1 year||||Watts||Standard Deviation|Mean
2746553|NCT00905268|Secondary|Change in Peak Systolic Strain Rate From Baseline to Week 52|Mean Change of Peak systolic longitudinal strain rate (PSLSR) from Baseline to Week 52 in subjects with cardiac involvement (FRDA-CM criteria), where positive value in PSLSR is a deterioration and negative value an improvement.|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)|||1/s||Standard Deviation|Mean
2746554|NCT00905268|Secondary|Proportion of Patients Improving on Left Ventricular Peak Systolic Strain Rate or Showing a Reduction in Left Ventricular Mass Index (LVMI) With no Worsening in Strain Rate|(In the statistical analysis sub-population presenting with cardiac involvement as defined by the FRDA cardiomyopathy criteria)|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)|||percentage of patients|||Number
2746555|NCT00905268|Secondary|Proportion of Patients Improving (Responding) on ICARS by a Clinically Relevant Margin|"The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.~ICARS Responder Analysis at Week 52: Percentage of subjects Improving by 2.5 Points or More."|week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.|||percentage of patients|||Number
2746622|NCT00904969|Primary|Procedural Endpoint: Procedure Time From First Incision to Closing.|Characterize procedure time from first incision to closing.|During Procedure, Approximately 60 Minutes||||minutes||Standard Deviation|Mean
2746556|NCT00905268|Secondary|Absolute Change in Friedreich's Ataxia Rating Scale (FARS) Scores From Baseline Assessment to Week 52|The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, and activities of daily living subscale and a neurological subscale. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|Baseline and week 52|The comparison was carried out in the ITT population, on data imputed using the last observation carried forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2746557|NCT00905268|Primary|Absolute Change in International Cooperative Ataxia Rating Scale (ICARS) Scores From Baseline Assessment to Week 52|The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline and week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.|||units on a scale||Standard Deviation|Mean
2746558|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||participants|||Number
2746559|NCT00905255|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period and “n” = patients with FPG assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||mmol/L||Standard Deviation|Mean
2746560|NCT00905255|Secondary|Change From Baseline in Body Weight for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline weight assessment during on-treatment period and “n” = patients with weight assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||kilogram||Standard Deviation|Mean
2746561|NCT00905255|Primary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||percentage of participants|||Number
2746562|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
2746563|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
2746623|NCT00904943|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746564|NCT00905255|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76|Absolute change = HbA1c value at week of assessment (Week 52/Week 76) minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of hemoglobin||Standard Deviation|Mean
2746565|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2746566|NCT00905255|Other Pre-specified|Percentage of Patients Requiring Rescue Therapy|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 4 to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 52, Baseline up to Week 76|mITT population.Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
2746567|NCT00905255|Secondary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
2746568|NCT00905164|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746569|NCT00905164|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746570|NCT00905164|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2746571|NCT00905151|Primary|Performance of Glomerular Filtration Rate (GFR) Estimating Equations|Overall bias, median difference (95% confidence interval), mL/min per 1.73 m^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.|Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.||||mL/min per 1.73 m^2||95% Confidence Interval|Median
2746572|NCT00905125|Primary|Number of Participants With a Four-fold or Greater Rise in HAI Antibody Titer Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a four-fold increase in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.|||Participants|||Number
2746573|NCT00905125|Secondary|Microneutralization Assay Geometric Mean Antibody Titers Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.|||Participants|||Number
2746624|NCT00904943|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
2746574|NCT00905125|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.|||Titer||95% Confidence Interval|Mean
2746575|NCT00905125|Primary|Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature|Participants recorded a daily oral temperature on a memory aid for 8 days (Days 0-7) after vaccination. The protocol defined mild fever as oral temperatures 37.8 to less than 38 degree Celsius, moderate fever as 38 to less than 39 degrees Celsius and severe fever as oral temperatures of 39 degrees Celsius or higher. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746576|NCT00905125|Primary|Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which systemic symptoms of feverishness, malaise, myalgia, headache and nausea were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746577|NCT00905125|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade|Participants recorded a daily measured value of swelling and redness, if present. The protocol defined grading of small, medium and large, with small as less than 20 mm, medium as 20-50 mm and large as greater than 50 mm. Participants are counted at the largest measured grade experienced across the 8 day period after vaccination.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746578|NCT00905125|Secondary|Number of Participants With a Four-fold or Greater Rise in Microneutralization Antibody Titer Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. The threshold of a four-fold increase in titer would be met if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.|||Participants|||Number
2746579|NCT00905125|Secondary|Number of Participants With a Serum Microneutralization Antibody Titer of Greater Than or Equal to 40 Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.|||Participants|||Number
2746580|NCT00905125|Primary|Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which local reactions of pain, tenderness and swelling were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746581|NCT00905125|Primary|Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746582|NCT00905125|Primary|Number of Participants Reporting Serious Adverse Events (SAE)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes. All events are included regardless of association to vaccination.|Through 6 months post vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746583|NCT00905125|Primary|Number of Participants Reporting Neonatal Complications.|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All live births are included in this outcome measure, which excludes three participants whose pregnancies ended in miscarriage or stillbirth (reported as maternal complications). Three participants gave birth to twins, who are each counted separately.|||Participants|||Number
2746584|NCT00905125|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.|||Participants|||Number
2746585|NCT00905125|Primary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV)|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.|||Participants|||Number
2746586|NCT00905034|Primary|Complete Response (CR) Rate|Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.|6 cycles (cycle = 28 days)|Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response.|||percentage of participants|||Number
2746587|NCT00905021|Secondary|Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells||5 years|||||||
2746588|NCT00905021|Secondary|Determine the Safety and Tolerability||5 years|||||||
2746589|NCT00905021|Secondary|Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival||5 years|The study was terminated early before target accrual.||||||
2746590|NCT00905021|Primary|Time to Disease Progression in Weeks|Time from the first day of treatment to date of progression in weeks|Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance|2 patients developed disease progression.|||week||Full Range|Mean
2746591|NCT00904995|Primary|Percentage of Samples With BG Levels > 60pg/ml|"Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI).~Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity."|Up to 42 days|Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.|||percent of blood samples|Participants||Number
2746592|NCT00904982|Primary|Improved Warfarin Adherence/% Timeout of Target INR Range||six months|This analysis required multiple INR results. If those were not available for a subject, they were excluded from the primary analysis.|||percentage of out of target INR range||Inter-Quartile Range|Median
2746593|NCT00904969|Secondary|Procedural and Device Complication Rates|Percentage of participants with serious and non-serious adverse events.|Procedure to 24 Months Post implant||||percentage of participants|||Number
2746594|NCT00904969|Secondary|Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status|Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations|6 Weeks post implant to 24 Months||||Participants|||Count of Participants
2746595|NCT00904969|Secondary|Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores|Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||score||Standard Deviation|Mean
2746596|NCT00904969|Post-Hoc|Urodynamic Results: Abdominal Leak Point Pressure|Abdominal leak point pressure (ALPP) is one indicator of improvement in continence symptoms. Abdominal leak point pressure was collected at baseline and 6-month follow-up as part of the urodynamic assessment.|Baseline and 6 Months Post Implant|18 participants did not have 6-month follow-up data|||participants|||Number
2746597|NCT00904969|Post-Hoc|Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Abnormal graphical representation of bladder pressure during urodynamics testing which is when the bladder is filled with saline water."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H2O||Standard Deviation|Mean
2746598|NCT00904969|Post-Hoc|Urodynamics Results: Detrusor Instability, Max Pdet|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.~Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.~The outcome measure data table shows the Pdet for patients with detrusor instability."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H2O||Standard Deviation|Mean
2746599|NCT00904969|Post-Hoc|Urodynamics Results: Detrusor Instability, Started at Filling Volume|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.~The measure data table shows the mean volume at the start of the urodynamic measurement study for patients with detrusor instability."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
2746625|NCT00904943|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2746648|NCT00904826|Secondary|Percentage Hemolysis|Percentage of hemolysis is a measure of complement activity. Less than 20% lysis is deemed to be complete complement inhibition.|baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months|Subject 13 was excluded at 3 months visit because she had temporarily discontinued treatment.|||percentage of hemolysis||Standard Deviation|Mean
2746600|NCT00904969|Post-Hoc|Urodynamics Results: Pdet at Qmax|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H20||Standard Deviation|Mean
2746601|NCT00904969|Post-Hoc|Urodynamics Results: Maximum Detrusor Pressure|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H2O||Standard Deviation|Mean
2746602|NCT00904969|Post-Hoc|Urodynamic Results: Bladder Capacity|Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.|Baseline and 6 Months Post implant|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
2746603|NCT00904969|Post-Hoc|Uroflow Studies: Post-Void Residual|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
2746604|NCT00904969|Post-Hoc|Uroflow Studies: Voided Volume|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
2746605|NCT00904969|Post-Hoc|Uroflow Studies: Average Flow Rates|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 Month|Number of subjects that did not have test performed at follow-up visit.|||ml/sec||Standard Deviation|Mean
2746606|NCT00904969|Post-Hoc|Uroflow Studies: Peak Flow Rate|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 month|Number of subjects that did not have test performed at follow-up visit.|||ml/sec||Standard Deviation|Mean
2746607|NCT00904969|Secondary|Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores|The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||score||Standard Deviation|Mean
2746608|NCT00904969|Secondary|Subject Satisfaction Endpoint: Quality of Life I-QOL Scores|The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||score||Standard Deviation|Mean
2746609|NCT00904969|Secondary|Subject Satisfaction Endpoint: Pads Per Day Use|Summarize the subject satisfaction using pads per day use collected in follow-up in participants.|Baseline to 24 Months|LOCF and WCS data are derived from data from the 24 month visit|||Participants|||Count of Participants
2746610|NCT00904969|Secondary|Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)|Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).|Baseline to 24 Month||||participants|||Number
2746611|NCT00904969|Secondary|Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)|Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).|Baseline to 24 month||||participants|||Number
2746612|NCT00904969|Secondary|Subject Satisfaction Endpoint: 24-Hour Pad Weight|Summarize subject satisfaction with 24-hour pad weight across participants.|Baseline to 24 month|LOCF and WCS data are derived from data from the 24 month visit|||grams||Standard Deviation|Mean
2746613|NCT00904969|Secondary|Subject Satisfaction Endpoint: 1-Hour Pad Weight|Summarize subject satisfaction of 1-hour pad weight for participants.|Baseline to 24 month|Last observation carried forward (LOCF) and worst case scenario (WCS) data are derived from data from the 24 month visit|||grams||Standard Deviation|Mean
2746614|NCT00904969|Primary|Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively|Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
2746615|NCT00904969|Primary|Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning|Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
2746616|NCT00904969|Primary|Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection|Characterize procedural parameters, including muscle dissection across all participants.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
2746617|NCT00904969|Primary|Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures|Characterize procedural parameters including the use of tack sutures.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
2746626|NCT00904917|Secondary|Child's Report on Parental Behavior Inventory (CRPBI)|Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents' perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the CRPBI, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).|||units on a scale||Standard Deviation|Mean
2746627|NCT00904917|Secondary|Understanding Mood Disorders Questionnaire (UMDQ)|Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the UMDQ, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).|||units on a scale||Standard Deviation|Mean
2746628|NCT00904917|Primary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the MASC which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).|||T scores||Standard Deviation|Mean
2746629|NCT00904917|Primary|Children Depression Inventory (CDI)|Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.|Measured at baseline and at post-treatment (8 weeks after baseline)|These scores are based on the CDI which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).|||T scores||Standard Deviation|Mean
2746630|NCT00904839|Secondary|Exploratory Biomarker and Pharmacogenetic Analysis for VEGF|"Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF).~Note: This endpoint was not statistically analysed in this study."|Day 1, Day 29, Day 57, Day 85 and Day 127|||||||
2746631|NCT00904839|Secondary|Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag.|Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag.|from baseline until end of treatment, up to 892 days|Treated Set (TS).|||participants|||Number
2746632|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects .~The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss).~Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales."|Baseline and 9 months.|Treated Set (TS)|||units on scale||Standard Deviation|Mean
2746633|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores.~Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores"|Baseline and 9 months.|Treated Set (TS). Number of analysed patients are the total number of patients who were analysed for the change from baseline at 9 months for Global health status scores|||units on scale||Standard Deviation|Mean
2746634|NCT00904839|Secondary|Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I)|Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration.|Treated Set (TS).|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2746649|NCT00904826|Secondary|Mean Serum Concentration of Eculizumab||6 weeks, 3 months, 6 months, 9 months, 12 months|Patient 13 was excluded from the 3 months measurement because she had temporarily discontinued treatment.|||micrograms/mL||Standard Deviation|Mean
2746635|NCT00904839|Secondary|Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I)|Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration.|Treated Set (TS).|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2746636|NCT00904839|Secondary|Maximum Tolerable Dose (MTD)|Determination of Maximum Tolerable Dose based on DLT incidence.|First two treatment cycles, up to 28 days|MTD Set|||mg|||Number
2746637|NCT00904839|Secondary|Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I).|Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary & skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets <25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 &bilirubin to normal or baseline within14days after nintedanib treatment interruption|First two treatment cycles, up to 28 days|MTD set: The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study. The outputs (updated with cleaned and more complete data) that were used to decide on the MTD of nintedanib while the study was ongoing.|||percentage of participants|||Number
2746638|NCT00904839|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days|Treated Set (TS)|||participants|||Number
2746639|NCT00904839|Secondary|Tumor Shrinkage|"For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:~<= - 30%~> - 30% and < 0%~>= 0% and < 20%~>=20%"|Baseline and day 85|Treated Set (TS)|||participants|||Number
2746640|NCT00904839|Secondary|Resection Rate|"Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease.~Peto's variance estimate was used."|First treatment administration until end of treatment, up to 892 days|Treated Set (TS)|||percentage of Participants||95% Confidence Interval|Number
2746641|NCT00904839|Secondary|Unconfirmed Objective Response Rate|Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||percentage of Participants||95% Confidence Interval|Number
2746642|NCT00904839|Secondary|Confirmed Objective Response Rate|Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||percentage of Participants||95% Confidence Interval|Number
2746643|NCT00904839|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||months||95% Confidence Interval|Median
2746644|NCT00904839|Secondary|Overall Survival|Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||months||95% Confidence Interval|Median
2746645|NCT00904839|Primary|Progression-free Survival Rate at 9 Months (PFS-9)|"PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).~20% increase in the sum of the longest diameter of target lesions.~The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|First treatment administration to nine months|Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug.|||percentage of Participants||95% Confidence Interval|Number
2746646|NCT00904826|Secondary|Mean Complement Protein 5 (C5) Concentration in CSF||baseline, 3 months|At 3 months, C5 was undetectable in 6 subjects; patient 13 was excluded because she had temporarily discontinued treatment.|||ng/mL||Standard Deviation|Mean
2746647|NCT00904826|Secondary|Mean Eculizumab Concentration in Cerebrospinal Fluid (CSF)||3 months|12 subjects including subject 13 agreed to have CSF draw at the 3 month visit, but subject 13 was excluded because she had temporarily discontinued treatment.|||ng/mL||Standard Deviation|Mean
2748119|NCT00890825|Secondary|Objective Response Rate|ORR is defined as the ratio of proportions, patients with at least one visit response of CR or PR in AZD6244 + Docetaxel vs Placebo + Docetaxel.|At least 12 months after start of treatment|MITT|||Participants|||Count of Participants
2746651|NCT00904826|Secondary|Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point|Visual acuity was measured using the the Visual Acuity subscale of the Opticospinal Impairment Score (OSIS) for Exacerbations. This subscale ranges from 0 (normal) to 8 (no light perception).|12 months||||participants|||Number
2746652|NCT00904826|Secondary|Change in Expanded Disability Status Scale (EDDS) Score|The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.|baseline, 12 months||||units on a scale||95% Confidence Interval|Mean
2746653|NCT00904826|Secondary|Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment||12 months||||participants|||Number
2746654|NCT00904826|Primary|Median Number of Neuromyelitis Optica (NMO) Attacks Per Year||baseline, after 12 months of treatment||||attacks per year||Full Range|Median
2746655|NCT00904748|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.|||participants|||Number
2746656|NCT00904748|Secondary|Half-life (T 1/2)|Terminal elimination half-life.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||hours||Standard Deviation|Mean
2746657|NCT00904748|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time at which maximum plasma concentration (Cmax) occurred.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||hours||Standard Deviation|Mean
2746658|NCT00904748|Secondary|Area Under the Curve From 0 to Infinity (AUC 0-inf )|Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||ng*hr/mL||Standard Deviation|Mean
2746659|NCT00904748|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration measured in nanograms per milliliter (ng/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||ng/mL||Standard Deviation|Mean
2746660|NCT00904748|Primary|Area Under the Curve (AUC 0-t)|Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||ng*hr/mL||Standard Deviation|Mean
2746661|NCT00904722|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.|Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.|||months||95% Confidence Interval|Median
2746662|NCT00904722|Primary|Overall Response Rate|Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.|Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.|||participants|||Number
2746663|NCT00904670|Other Pre-specified|SKAMP Compliance Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746695|NCT00904371|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)|Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)|||Percentage of participants|||Number
2748333|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 0.9 - 1.74 Years||16 Weeks|Subjects who had been diagnosed with PAH between 0.9 and 1.74 years prior to Baseline.|||meters||Inter-Quartile Range|Median
2746664|NCT00904670|Other Pre-specified|SKAMP Quality of Work Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746665|NCT00904670|Secondary|SKAMP Combined Scores Over 12 Hours|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Data for combined SKAMP score was collected and reported through the measure of onset and duration of clinical effects as given in outcome measure 2.||||||
2746666|NCT00904670|Secondary|Permanent Product Measure of Performance (PERMP) Score Over 12 Hours|The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746667|NCT00904670|Secondary|SKAMP Deportment Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746668|NCT00904670|Secondary|SKAMP Attention Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746669|NCT00904670|Secondary|Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale|Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746696|NCT00904371|Secondary|Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)|||Percentage of participants|||Number
2746697|NCT00904371|Primary|Change From Baseline in Risk Assessment According to ESH/ESC Guidelines|ESH is the European society of hypertension, and ESC is the European society of cardiology.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||Participants moved into category|||Number
2748334|NCT00887978|Post-Hoc|6-minute Walk Distance by Time to PAH Diagnosis: 0 - 0.9 Years||Baseline and 16 weeks|Subjects who have been diagnosed with PAH between 0 to 0.9 years prior to Baseline.|||meters||Inter-Quartile Range|Median
2746670|NCT00904670|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|Hour 4 post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2746671|NCT00904618|Secondary|Safety of the Sling.|Safety of the sling was assessed with a record of perioperative and postoperative complications. The following are all the complications experienced with the TVT-SECUR for each technique, the 'Hammock' technique and the 'U-Method'.|15 months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the ‘U-Method’.|||Participants|||Number
2746672|NCT00904618|Secondary|Improvement in Stress Urinary Symptoms.|A questionnaire with a Likert scale from one to five was used to assess the improvement in stress urinary symptoms at six months for each technique, the 'Hammock' technique and the 'U-Method' (1-Worst, 2-Same, 3-Improved, 4-Almost cured, 5-Cured). Patients had to answer 3 or more on the scale to be considered improved.|Six months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Seven patients for the 'Hammock' technique and three patients for the 'U-Method' did not fill out the questionnaire at six months.|||participants|||Number
2746673|NCT00904618|Primary|Local Anesthesia Satisfaction|Local anesthesia satisfaction was assessed with a questionnaire completed by the patients. The patients were asked if they would recommend this type of anesthesia (yes or no).|Questionnaire filled 1 week after surgery|2 patients did not fill out the questionnaire 1 week after surgery|||participants|||Number
2746674|NCT00904488|Secondary|Blood Urea Nitrogen (BUN)||Baseline, 24, 48, 72, 96 hours||||mg/dL||Standard Deviation|Mean
2746675|NCT00904488|Secondary|Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic||30 days|30-day follow up data (except for mortality) were not collected in 2 participants|||Participants|||Count of Participants
2746676|NCT00904488|Secondary|Rehospitalization at 30 Days||30 days|30-day follow up data (except for mortality) were not collected in 2 participants|||Participants|||Count of Participants
2746677|NCT00904488|Secondary|30-day All-cause Mortality||30 days||||Participants|||Count of Participants
2746678|NCT00904488|Secondary|Length of Hospitalization||Assessed till hospital discharge, an average of 1 week (longest 29 days)|Data not available in all subjects.|||Days||Standard Deviation|Mean
2746679|NCT00904488|Secondary|Time to Return to Baseline Weight||0-96 hours|Weight was not collected in all subjects every day.|||Days||Standard Deviation|Mean
2746680|NCT00904488|Secondary|Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure)|Patients will be considered a treatment failure if they require additional diuretic (including crossover to the alternative study arm) or require IV vasoactive drug therapy (e.g. vasodilators including nitroglycerin or inotropes) as deemed appropriate/necessary by their medical team.|0-96 hours||||Participants|||Count of Participants
2746681|NCT00904488|Secondary|Physician Global Assessment Scale|"Scale range: 1-5 Which of the following best describes the patient's overall health state today?~= markedly worse~= worse~= neither better nor worse~= better~= markedly better"|Baseline, 24, 48, 72, 96 hours|Data were not collected at all time points, and were only analyzed when available.|||units on a scale||Standard Deviation|Mean
2746682|NCT00904488|Secondary|Patient Global Assessment Scale|"Scale range: 1-5 Which of the following best describes your overall health state today?~= markedly worse~= worse~= neither better nor worse~= better~= markedly better"|Baseline, 24, 48, 72, 96 hrs|Data were not collected at all time points, and were only analyzed when available.|||units on a scale||Standard Deviation|Mean
2746683|NCT00904488|Secondary|Daily Weight||Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrs|Data were not collected for all subjects at all time points, and were only analyzed when available|||Kg||Standard Deviation|Mean
2746684|NCT00904488|Secondary|Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)||0-24, 24-48, 48-72, 72-96 hrs|Data were not collected at all time points for all subjects, and were only analyzed when available. Data not analyzed on days when diuretics were held or discontinued.|||ml/mg furosemide received||Standard Deviation|Mean
2746685|NCT00904488|Secondary|Daily Net Fluid Output on Days 1, 3, and 4|Daily net fluid output = daily fluid output - daily intake. A negative value means that daily fluid intake was less than the daily fluid output.|0-24, 48-72, 72-96 hrs|If diuretic therapy is changed to the oral route before a scheduled efficacy endpoint is to be measured (e.g.72 or 96 hour net output), then that endpoint will not be obtained.|||ml/day||Standard Deviation|Mean
2746686|NCT00904488|Primary|Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)|Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.|24-48 hours||||mL/day||Standard Deviation|Mean
2746687|NCT00904423|Secondary|Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio||every 4 months|Data are not accessible.||||||
2746688|NCT00904423|Secondary|Arthralgias and Myalgias||every 4 months|Data are not accessible.||||||
2746689|NCT00904423|Secondary|Bone Turnover Markers||months 4 and 12|Data are not accessible.||||||
2746690|NCT00904423|Secondary|Change in Hip Bone Mineral Density (BMD) T-score||one year|Data are not accessible.||||||
2746691|NCT00904423|Primary|Spine Bone Mineral Density T Score Change Over One Year||1 year|Data are not accessible.||||||
2748335|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA + PDE-5i||16 weeks|Subjects receiving both an ERA and a PDE-5i at Baseline.|||meters||Inter-Quartile Range|Median
2746698|NCT00904371|Primary|Change From Baseline in Framingham Stroke Risk Assessment Score|The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||units on a scale||Standard Deviation|Mean
2746699|NCT00904371|Primary|Change From Baseline in Framingham CVD Risk Assessment Score|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||units on a scale||Standard Deviation|Mean
2746700|NCT00904371|Primary|Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||units on a scale||Standard Deviation|Mean
2746701|NCT00904371|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||mm Hg||Standard Deviation|Mean
2746702|NCT00904371|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||mm Hg||Standard Deviation|Mean
2746703|NCT00904215|Primary|Change in WHO-QOL (WHO-Quality Of Life)|"World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.~Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)"|between baseline (visit 1) and after 12 weeks of treatment (visit 3)||||Units on a scale||Standard Deviation|Mean
2746704|NCT00904215|Secondary|Change in VAS (Visual Analog Scale)|VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)|between baseline (visit 1) and after 12 weeks of treatment (visit 3)||||Units on a scale||Standard Deviation|Mean
2746705|NCT00904215|Primary|Change in DBP (Diastolic Blood Pressure)|The change of the mean DBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)||||mmHg||Standard Deviation|Mean
2746706|NCT00904215|Primary|Change in SBP (Systolic Blood Pressure)|The change of the mean SBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|In clinical report form (CRF), some patients' SBP was not recorded.|||mmHg||Standard Deviation|Mean
2746707|NCT00904189|Secondary|Determination of the Range of Background Signal Measured by the EPR Device.||2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.||||||
2746708|NCT00904189|Primary|Mean Dose of Radiation Received by Fingernails|The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).|2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.||||||
2746709|NCT00904150|Secondary|Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine|TNF and SYNE1|6 years|Matched luteal and follicular phase samples Not all samples were suitable for analysis for each outcome measure|||number of genes expressed||Standard Deviation|Mean
2746710|NCT00904150|Primary|Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine|PgR and ESR|6 years|Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure|||number of genes expressed||Standard Deviation|Mean
2746711|NCT00904150|Primary|Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 C325G|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
2746712|NCT00904150|Secondary|SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine|SYNE1|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
2746713|NCT00904150|Secondary|Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine|TNF|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
2746714|NCT00904150|Primary|Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 G594A|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
2746715|NCT00904150|Primary|Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine|PR PROGINS|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
2746716|NCT00904033|Secondary|Body Mass Index (Calcitriol)|"Body Mass Index(BMI) - (Calcitriol comparison)~Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent Underweight, 18.5 to 24.9 represent Normal or Healthy Weight, 25.0 to 29.9 represent Overweight and 30.0 and above represent Obese."|Week 12|"No Calcitriol group consists of Multivitamin arm and Exercise arm N=16*; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=20** * 4 subjects have missing data for this outcome.~** 1 subject has missing data for this outcome."|||kg/m^2||Standard Error|Mean
2746717|NCT00904033|Secondary|Body Mass Index (Exercise)|"Body Mass Index (BMI) - (Exercise Comparison)~Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent Underweight, 18.5 to 24.9 represent Normal or Healthy Weight, 25.0 to 29.9 represent Overweight and 30.0 and above represent Obese."|Week 12|"No Exercise group consists of Multivitamin and Calcitriol arms N=16*; Exercise group consists of Exercise and Calcitriol+Exercise arms N=20** *4 subjects have missing data for this outcome.~**1 subject has missing data for this outcome."|||kg/m^2||Standard Error|Mean
2746733|NCT00904007|Secondary|Cross-cohort Comparison of Frequency of Treatment Intensification||Months 1-24|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2748336|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA Only||Baseline and 16 weeks|Subjects who were only receiving an ERA at Baseline|||meters||Inter-Quartile Range|Median
2746718|NCT00904033|Secondary|Handgrip (kg) Strength - (Calcitriol)|"Handgrip (kg) Strength - (Calcitriol comparison)~Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength."|Week 12|"No Calcitriol group consists of Multivitamin arm and Exercise arm N=14*; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=17** * 6 subjects have missing data for this outcome.~** 4 subjects have missing data for this outcome."|||kg||Standard Error|Mean
2746719|NCT00904033|Secondary|Handgrip (kg) Strength - (Exercise)|"Handgrip (kg) Strength (Exercise comparison)~Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength."|Week 12|"No Exercise group consists of Multivitamin and Calcitriol arms N=14*; Exercise group consists of Exercise and Calcitriol+Exercise arms N=17** * 6 subjects have missing data for this outcome.~** 4 subjects have missing data for this outcome."|||kg||Standard Error|Mean
2746720|NCT00904033|Primary|Bone Formation (Calcitriol)|"Bone Formation using Serum BSAP (Calcitriol comparison)~The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies."|Week 12|"No Calcitriol group consists of Multivitamin arm and Exercise arm N=20; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=20**~** 1 subject has missing data for this outcome."|||ng/ml||Standard Error|Least Squares Mean
2746721|NCT00904033|Primary|Bone Formation (Exercise)|"Bone Formation using Serum BSAP (Exercise comparison)~The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies."|Week 12|"No Exercise group consists of Multivitamin and Calcitriol arms N=20; Exercise group consists of Exercise and Calcitriol+Exercise arms N=20**~**1 subject has missing data for this outcome."|||ng/ml||Standard Error|Least Squares Mean
2746722|NCT00904033|Primary|Bone Resorption (Calcitriol)|"Bone Resorption using Serum NTx (Calcitriol comparison)~Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE)."|Week 12|"No Calcitriol group consists of Multivitamin arm and Exercise arm N=20; Calcitriol group consists of Calcitriol and Calcitriol+Exercise arms N=19**~** 2 subjects have missing data for this outcome."|||nm BCE||Standard Error|Least Squares Mean
2746723|NCT00904033|Primary|Bone Resorption (Exercise)|"Bone Resorption using Serum NTx (Exercise comparison)~Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE)."|Week 12|"No Exercise group consists of Multivitamin and Calcitriol arms N=20; Exercise group consists of Exercise and Calcitriol+Exercise arms N=19**~** 2 subjects have missing data for this outcome."|||nm BCE||Standard Error|Least Squares Mean
2746724|NCT00904007|Secondary|Provider-perceived Barriers and Facilitators to the Spaced Education Intervention||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746725|NCT00904007|Secondary|Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746726|NCT00904007|Secondary|Provider-perceived Effectiveness of Spaced Education Intervention||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746727|NCT00904007|Secondary|Provider-perceived Acceptability of Spaced Education Intervention||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746728|NCT00904007|Secondary|Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746729|NCT00904007|Secondary|Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746730|NCT00904007|Secondary|Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746731|NCT00904007|Secondary|Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)||Month 1|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746732|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure||Months 1-24|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746734|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)||Months 1-24|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746735|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)||Months 1-24|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746736|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)||Months 13-24|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746737|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)||Months 13-24|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746738|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746739|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)||Months 1-12|PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.||||||
2746740|NCT00904007|Primary|Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure|A unique hypertensive period served as the unit of analysis. A hypertensive period started on the first day during the study when a patient's BP was elevated. It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study. Duration of the hypertensive period (days) was the outcome measure. BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits. These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described. If several measurements were recorded on the same day, the lowest mean arterial BP was used.|Months 1-24||||days||Full Range|Median
2746741|NCT00903968|Secondary|Duration of Response (DOR) [Phase II]|DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.|DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.|All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for DOR.|||Months||95% Confidence Interval|Median
2746742|NCT00903968|Secondary|Time to Progression (TTP) [Phase II]|TTP estimated using the Kaplan-Meier method is defined as the time from registration to progression based on IMWG criteria or date last known progression-free for those who have not progressed. [Durie BG et al. Leukemia. 2006] Progression (PD): ≥ 25% increase from lowest value reported in serum M-component (absolute increase ≥0.5 g/dL) and/or urine M-component (absolute increase ≥200 mg/24 hours); if appropriate, a ≥25% increase above the lowest level in the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); If none of these are measurable then ≥25% increase in bone marrow plasma cell percentage above the lowest response level (absolute ≥10%); Definite development of new bone lesions or soft tissue plasmacytomas OR increase in size of existing|DIsease was assessed to document progression every cycle on treatment and post-treatment every 12 weeks until progression.|All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for TTP.|||Months||95% Confidence Interval|Median
2746743|NCT00903968|Primary|Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]|Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component <100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component <200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).|Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.|All participants with measureable disease at baseline and received at least one dose of the study drug were evaluable for response.|||Participants|||Count of Participants
2746744|NCT00903968|Primary|Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as (a) grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to plerixafor or bortezomib, with the exception of nausea, vomiting or diarrhea unless receiving maximal medical therapy, (b) grade 4 hematologic toxicity defined as: thrombocytopenia with platelets <10,000 on more than one occasion within first cycle despite transfusion. Grade 4 neutropenia must occur for more than 5 days and/or result in neutropenic fever with elevated temperature (defined as > 101 degrees F). (c) inability to receive Day 1 dose for Cycle 2 due to toxicity. All adverse events were graded according to the CTEP Common Toxicity Criteria (CTCAE v.3.0).|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for DLT.|||Participants|||Count of Participants
2746765|NCT00903695|Secondary|Number of Subjects Who Converted to Early Alzheimer's (Dementia).|Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.|12 months|Subjects diagnosed as Mild Cognitive Impairment (MCI) in VA clinic were given opportunity to participate in the study if they met inclusion/exclusion criteria (no illnesses that cause brain damage or are uncontrolled such as brittle diabetes).|||participants|||Number
2746745|NCT00903968|Primary|Bortezomib Maximum Tolerated Dose (MTD) [Phase I]|The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of bortezomib was given on days 3, 6, 10, 13 of 21 each cycle.|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for MTD.|||mg/m2|||Number
2746746|NCT00903968|Primary|Plerixafor Maximum Tolerated Dose (MTD) [Phase I]|The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for MTD.|||ug/kg|||Number
2746747|NCT00903929|Secondary|Median Number of Platelet Transfusions up to the Day of Engraftment||baseline to day of engraftment||||units of platelets||Full Range|Median
2746748|NCT00903929|Secondary|Median Time to Platelet Engraftment|Determined for all participants who completed at least 75% of the planned doses. Platelet engraftment was as defined by the Center for International Blood and Marrow Transplant Research as the first of 3 consecutive days of a platelet count 20,000/mL without platelet trans-fusions for 7 days and/or the first day of a platelet count 100,000/mL without platelet transfusions for 7 days.|1.5 years||||days||Full Range|Median
2746749|NCT00903929|Primary|Maximum Tolerated Dose (MTD) of Eltrombopag|The MTD was defined as the highest dose if no dose limiting toxicity was observed, or the highest dose at which less than one-third of the patients experienced toxicities not expected in the standard stem cell transplantation setting.|1.5 years||||mg/day|||Number
2746750|NCT00903877|Primary|Visual Analogue Scale of Pain Intensity|Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).|12 weeks||||Units on a scale||Standard Deviation|Mean
2746751|NCT00903786|Secondary|The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment|The investigator evaluated each participant for CGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing medical conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.|Week 52 and End of Treatment, up to approximately 7 years 2 months|Efficacy Analysis Population|||Percentage of participants|||Number
2746752|NCT00903786|Secondary|The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment|Each participant evaluated him/herself for PGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing seizure conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.|Week 52 and End of Treatment; up to approximately 7 years 2 months|Efficacy Analysis Population|||Percentage of participants|||Number
2746753|NCT00903786|Secondary|Responder Rate During the Treatment Period-LOCF|"Responder rate (percentage of participants with greater than or equal to 50% reduction in seizure frequency for 28 days in the Treatment Period relative to that for 28 days in the observation period of Study 231 [responder]. If the reduction in seizure frequency is less than 50%, then the participants are considered as non-responders.~LOCF = Last Observation Carried Forward."|Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months|Efficacy Analysis Population|||Percentage of participants|||Number
2746754|NCT00903786|Secondary|Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316|Seizure frequency was derived from information (seizure count and type) recorded in the participant diary. The seizure frequency per 28 days was calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. Of the 21 participants, 20 participants concomitantly used at least 1 inducer anti-epileptic drug (AED) (carbamazepine, phenytoin, phenobarbital, or primidone), and 1 participant used only non-inducer AEDs. The data is presented as median percent change with full range.|From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months|"The Efficacy Analysis Population (identical to the SAS for this study) was defined as all participants who met the inclusion/exclusion criteria regarding indication (inclusion criteria number 5 of Study 231), who received at least one dose of study treatment, and who had at least one data on efficacy."|||Percent change in seizure frequency||Full Range|Median
2746766|NCT00903682|Secondary|Resistance Determinations|The evolution of viral genotype and phenotype was assessed by the number of patients with resistance-associated mutations emerging at the endpoint. A mutation was considered emerging if it was present at endpoint and not present at baseline or any pre-baseline assessment. (NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; RAM = resistance-associated mutation, IAS-USA = International AIDS Society - USA)|at baseline and all subsequent visits until week 48 in case if virologic failure|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol|||number of participants|||Number
2748337|NCT00887978|Post-Hoc|6-minute Walk Distance by Background PAH Therapy: PDE-5i Only||16 weeks|Subjects receiving only a PDE-5i at Baseline|||meters||Inter-Quartile Range|Median
2746755|NCT00903786|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|"Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 Classification of Severity of Adverse Drug Reactions of Medicinal Products. TEAEs were defined as AEs that emerged during treatment (absent at pretreatment [Baseline]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous."|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months|"The Safety Analysis Set (SAS) was defined as all participants who met the inclusion/exclusion criteria regarding indication (inclusion criteria number 5 of Study 231), who received at least one dose of study treatment, and who had at least one evaluable set of safety data."|||Participants|||Number
2746756|NCT00903760|Secondary|Participant Response|Responses: Complete Remission (CR): Normalization peripheral blood & bone marrow </= 5% bone marrow blasts, no evidence dysplasia; peripheral blood granulocyte >/= 1.0 x 10^9/L, & platelet>/= 100 x 10^9/L. Partial Remission: all CR criteria if abnormal before treatment except marrow blasts decrease =/> 50% compared to pretreatment or a less-advanced MDS disease classification than prior to treatment. Hematologic Improvement: Response maintained 8+ weeks: Hemoglobin (pretreatment < 11 g/dL): improves 1.5 g/dL or reduced by 4 units of red blood cell (RBC) transfusions in 8 weeks compared with pretreatment transfusions in 8 weeks; or Platelet (pretreatment < 100 x 10^9/L): absolute increase >/= 30 x 10^9/L, starting platelet > 20 x 10^9/L OR increase < 20 x 10^9/L to > 20 x 10^9/L and =/> 100%. Neutrophil (pretreatment < 1 x 10^9/L): increase 100% & absolute increase > 0.5 x 10^9/L.|Up to 6 months|One of 18 participants in the Decitabine arm was not treated due to early death thus is excluded from analysis.|||participants|||Number
2746757|NCT00903760|Primary|Event Free Survival (EFS) at 1 Year|Percentage of participants with event free survival at 1 year. Event free survival (EFS) where event is defined as either death or transformation to acute myeloid leukemia (AML) (marrow and/or blood blasts >/= 20%)|Assessed at 12 months/1 year|One of 18 participants in the Decitabine arm was not treated due to early death thus is excluded from analysis.|||percentage of participants|||Number
2746758|NCT00903695|Primary|Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group|IADL is a behavior rating scale using 9 domains of household and community activities, with a total score of 27 points indicating less competence than a normal function score of 9 points. Outcome measure is results of an ANOVA of the differences between baseline and end/last score, by study arm/group, to detect statistically significant differences (nutriceutical vs placebo).|baseline to 12 months|All subjects who completed 12-month study were included.|||units on a scale||Standard Error|Mean
2746759|NCT00903695|Primary|Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group|ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.) in which a maximum score of 18 indicates less competence than a minimum score of 6 (normal skills). Outcome measure is results of ANOVA of the differences between baseline and last/end scores, by study arm/group, to detect any statistically significant differences.|baseline to 12 months|All subjects who completed 12-month study were included.|||units on a scale||Standard Error|Mean
2746760|NCT00903695|Primary|Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group|NPI is a behavior rating scale with 12 categories in which a maximum score of 36 points indicates more pathology than a minimum score of 0. Outcome measure reported here is results of an ANOVA of the differences between baseline and end scores, by study arm/group, to detect any statistically significant difference (nutriceutical vs placebo groups) was completed.|baseline to 12 months|All subjects who completed 12-month study were included.|||units on a scale||Standard Error|Mean
2746761|NCT00903695|Primary|Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group|MiniMental State Exam is a cognitive screening device with possible 30 points in several categories; higher points indicate greater competence. Clinician tests orientation, attention, language, & visuo-spatial construction. Outcome measure is results of an ANOVA of differences between baseline and end/last scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.|||units on a scale||Standard Error|Mean
2746762|NCT00903695|Primary|Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group|Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-month study. ANOVA of the differences between baseline and end scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.|||units on a scale||Standard Error|Mean
2746763|NCT00903695|Primary|Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group|CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.|baseline before intervention to 12 months of intervention|All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups).|||units on a scale||Standard Error|Mean
2746764|NCT00903695|Primary|Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group|Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.|Baseline and 12 months|All participants who completed 12-month study were included in the ANOVA analysis of the differences in scores of tests between baseline and end assessments.|||units on a scale||Standard Deviation|Mean
2746767|NCT00903682|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at baseline and week 2, 6, 12, 24, 36 and 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol|||number of cells/L (x10^6)||Standard Error|Mean
2746768|NCT00903682|Secondary|Neuropsychiatric Adverse Events by Week 48|The percentage of patients with at least 1 treatment emergent Grade 1 -4 neurologic or psychiatric adverse event, judged by the investigator to be at least possibly related to the study drug.|from baseline to week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||percentage of patients|||Number
2746769|NCT00903682|Secondary|Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score|"The HIV Patient Symptoms Profile measures the tolerability of HIV treatment from the patient's perspective, using 14 concept scales in maximum 84 questions. The response options include a no or yes answer to Did symptom occur?. If yes, there is a problem scale which ranges from 1 = I had this symptom and it was not a problem to 5 = I had this symptom and it was a severe problem. A neuropsychiatric tolerability score is composed as the sum of 21 items and ranges from 0 (best) to 105 (worse). A total Tolerability score (ie, the sum of all items) ranges from 0 (best) to 420 (worse)"|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||points on a scale||Standard Error|Mean
2746770|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <200 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||Number of participants|||Number
2746771|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <50 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||Number of participants|||Number
2746772|NCT00903682|Primary|Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event|"Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table). Grade 1-4 covers all severities."|between baseline and 12 weeks|The intent-to-treat (ITT) population has been defined as the set of all patients who were randomized and who have taken at least one dose of trial medication, regardless of their compliance with the protocol.|||percentage of patients|||Number
2746773|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:~At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s)."|6 months after starting treatment||||participants|||Number
2746774|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:~At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."|3 months after starting treatment||||participants|||Number
2746775|NCT00903630|Primary|Phase 2 - Number of Subjects Achieving a Partial or Complete Response|"Partial response is defined as:~At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.~Complete response is defined as:~The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|3 months after starting treatment||||participants|||Number
2746776|NCT00903630|Primary|Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.|within 5 weeks of starting treatment||||participants|||Number
2746777|NCT00903630|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).|1 cycle (28 days)||||milligrams (mg)|||Number
2746778|NCT00903617|Secondary|Plasma PK- AUC(0-t)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine AUC(0-t) was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Analysis Population. Only those participants available at the indicated time points were analyzed.|||Hour nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2746779|NCT00903617|Secondary|Plasma PK- Time of Occurrence of Cmax (Tmax)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Tmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The time at which Cmax was observed was determined directly from the raw concentration-time data.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Population.|||Hours||Full Range|Median
2746780|NCT00903617|Secondary|Plasma PK- Maximum Observed Concentration (Cmax)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Cmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The first occurrence of the Cmax was determined directly from the raw concentration-time data.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Population was defined as all participants in the PK concentration population for whom PK parameters had been derived.|||Nanograms per mililiter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2746781|NCT00903617|Secondary|Percent Change From Baseline in Non-esterified Fatty Acids (NEFA) Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of NEFA was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2746782|NCT00903617|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of Lp[a] was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2746783|NCT00903617|Secondary|Percent Change From Baseline in Insulin Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of insulin was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2746784|NCT00903617|Secondary|Percent Change From Baseline in Fasting Levels of Total Cholesterol (TC), Triglyceride (TG), Glucose, Low Density Lipoprotein Cholesterol (LDLc), Apolipoprotein A2 (ApoAII), Apolipoprotein B (ApoB) Over 8 Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of fasting levels of TC, TG, glucose, LDLc, ApoAII and ApoB was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2746785|NCT00903617|Secondary|Percent Change From Baseline in Fasting Plasma HDLc and Apolipoprotein A-I (ApoA1) Concentrations Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of fasting levels of HDLc and ApoA1 was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2746786|NCT00903617|Secondary|Mean Episode of Flushing as Measured by Visual Analogue Scale (VAS)|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants self-assessed intensity of flushing using a 100 mm VAS once daily at the first flushing episode. The left hand side of the scale (0) represented 'No Flushing Sensation' and the right hand side of the scale (100) represented 'Unbearable Flushing Sensation'. The intensity of flushing of each episode was measured in centimeters (to the nearest 1/100) from the 0 point of the scale. Data is reported for average VAS scores over 8 weeks of treatment.|Up to Week 8|PD Population was defined as all participants who provided PD data.|||Scores on a scale||Standard Deviation|Mean
2746787|NCT00903617|Secondary|Number of Participants Who Withdrew Due to Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits.|Up to follow up (14 days from last dose)|Safety Population.|||Participants|||Count of Participants
2746788|NCT00903617|Secondary|Participant's Average Duration of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participant's average duration of flushing was analyzed.|Up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Minutes||Full Range|Median
2746789|NCT00903617|Secondary|Average Time to Onset of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. The time to the onset of the first flushing (if more than one happens to occur on each day) was analyzed.|Up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
2746790|NCT00903617|Secondary|Average Number of Flushing Episodes|"Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants with average number of flushing episodes was reported as did not have flushing episode, 1 flushing episode, 2 flushing episode and 3 or more flushing episode."|Up to Week 8|PD Population.|||Participants|||Count of Participants
2746791|NCT00903617|Secondary|Number of Participants With Self Reported Assessment of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants were asked to perform an assessment of their perceived flushing intensity after their completion of VAS assessment once daily after their first flushing episode (if more than one happens to occur). The scale was from 0 to 3, where 0 represents no flushing, 1 represents mild flushing, 2 represents moderate flushing, and 3 represents severe flushing.|Up to Week 8|PD Population.|||Participants|||Count of Participants
2746792|NCT00903617|Secondary|Average Global Flushing Score|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Flushing symptom questionnaire (FSQ) was used to measure participant reported feelings of severity associated with different types of flushing symptoms. The FSQ comprised of 11 items. The response scale combined verbal descriptors as well as a 0-10 numerical rating scale. Items 1, 2, 4 and 10 had verbal descriptors. The items 3, 5, 6, 7, 8, 9 and 11 were rated on a 0 to 10 scale (none=0, mild=1-3, moderate=4-6, severe=7-9 and extreme=10). The total score for these items ranged from 0 (not at all) to 70 (extreme). Higher score indicated more severe flushing symptoms and 0 indicated no flushing symptoms.|Up to Week 8|PD Population.|||Participants|||Count of Participants
2746793|NCT00903617|Secondary|Number of Participants With Abnormal Urinalysis Results|Urinalysis assessment was done for urine occult blood, urine glucose, urine ketones and urine protein over eight weeks treatment period.|Up to Week 8|Safety Population.|||Participants|||Count of Participants
2746794|NCT00903617|Secondary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples for assessment of clinical chemistry parameters of blood urea nitrogen, creatinine, glucose (fasting), sodium, creatine phosphokinase, potassium, chloride, total carbon dioxide, calcium, total lactose dehydrogenase (LDH), aspartate aminotransferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, phosphate, total and direct bilirubin, uric acid, albumin and total protein was collected at Baseline and at Weeks 2, 4, 6 and 8.|Up to Week 8|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2746795|NCT00903617|Secondary|Number of Participants With Abnormal Hematology Values|Blood samples for assessment of hematology parameters of platelet count, red blood cell count, white blood cell count, hemoglobin, haptoglobin, reticulocyte count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils was collected at Baseline and at Weeks 2, 4, 6 and 8.|Baseline (Week 0) up to Week 8|Safety Population.|||Participants|||Count of Participants
2746796|NCT00903617|Secondary|Change From Baseline in Vital Signs-Heart Rate|Heart rate was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.|Baseline (Week 0) up to Week 8|Safety Population. Only those participants available at the indicated time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2746797|NCT00903617|Secondary|Change From Baseline in Vital Signs-Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.|Baseline (Week 0) up to Week 8|Safety population. Only those participants available at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2746798|NCT00903617|Secondary|Number of Participants With Electrocardiography (ECG) Findings|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. Participants with normal, abnormal- clinically significant (CS) and abnormal- not clinically significant (NCS) ECG values were reported.|Up to Week 8|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2746799|NCT00903617|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or it is associated with liver injury and impaired liver function.|Up to follow up (14 days from last dose)|Safety Population was defined as all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2746816|NCT00903370|Secondary|Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge||Less than 30 days post-procedure or hospital discharge||||percentage of patients||95% Confidence Interval|Number
2746817|NCT00903370|Primary|Freedom From Atrial Fibrillation||Measured at Month 12|Since the primary analysis is an intent-to-treat, outcomes were imputed for patients with missing data.|||percentage of patients||95% Confidence Interval|Number
2746800|NCT00903617|Primary|The GSK256073 Area Under Concentration-time Curve (AUC) and High Density Lipoprotein Cholesterol (HDLc) Data to Evolve the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship for Changes in HDLc Levels|The potential PK/PD relationship was to be assessed by plotting GSK256073 AUCs against HDLc. The PK/PD model that was to be used for the simulations in the study design was to be refined with the Part A observed AUC exposures and HDLc levels. However, the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.|Week 2, 4, 6 and 8|Data was not collected as the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.||||||
2746801|NCT00903448|Primary|Mean Percent Time That Gastric pH > 4.0 on Day 5|for 24 hours starting Day 5 for each period|24 hours|This study was a three period, crossover study of 40 subjects entering either treatment sequence ABB or BAA; consequently each subject in the study participated in three periods over which each subject would eventually receive both Prilosec OTC and Prevacid|||percent time gastric pH exceeds 4.0||Standard Error|Mean
2746802|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial|Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial|ITT Population|||Percentage change||Full Range|Median
2746803|NCT00903409|Secondary|"Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers"|Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|Months 4, 12, and 24 (LOV111818) of the open-label extension trial|ITT Population|||Percent change||Full Range|Median
2746804|NCT00903409|Primary|Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)|Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)|Month 4 (LOV111818)|Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication|||Percent change||Full Range|Median
2746805|NCT00903396|Secondary|Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2746806|NCT00903396|Secondary|Tolerability and Adverse Events as Assessed by NCI CTC v 3.0||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2746807|NCT00903396|Secondary|Proportion of Patients Reporting Treatment Failure||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2746808|NCT00903396|Secondary|Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2746809|NCT00903396|Primary|Complete Response (no Episodes of Nausea or Vomiting)||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2746810|NCT00903383|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12|The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population|||mm||Standard Deviation|Mean
2746811|NCT00903383|Secondary|Change From Baseline in C-reactive Protein (mg/L) at Week 12|The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population|||mg/L||Standard Deviation|Mean
2746812|NCT00903383|Secondary|Hybrid ACR Response at Week 12|Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. The percentage improvement from baseline was computed in each of the components of the ACR. The average percent improvement was calculated and used with the subject's ACR20, ACR50, and ACR70 status to compute the hybrid ACR response, with a positive change indicating improvement.|Baseline and 12 weeks|Intent to Treat Population|||Percent change||Standard Deviation|Mean
2746813|NCT00903383|Secondary|ACR70 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 70% response criteria (ACR70) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR70, there had to be ≥70% improvement in swollen joint count, ≥70% improvement in painful/tender joint count, and ≥70% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population|||Participants|||Number
2746814|NCT00903383|Secondary|ACR50 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 50% response criteria (ACR50) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR50, there had to be ≥50% improvement in swollen joint count, ≥50% improvement in painful/tender joint count, and ≥50% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population|||Participants|||Number
2746815|NCT00903383|Primary|ACR20 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population|||Participants|||Number
2746818|NCT00903357|Primary|Changes in Urinary EDN|Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml.|18 weeks after participants recruitment||||Urine EDN (ng/ml)||Standard Deviation|Mean
2746819|NCT00903357|Primary|Changes in Urinary LTE4|Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml.|18 weeks after patient recruitment||||Urinary LTE4 (pg/ml)||Standard Deviation|Mean
2746820|NCT00903357|Primary|Changes in SCORAD Index|Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index >40: severe, 15-40:moderate, <15: mild)|18 weeks after patient recruitment||||units on a scale||Standard Deviation|Mean
2746821|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months|difference in the mean|Change from Baseline to 6 Months||||grams/cm^2||Standard Deviation|Mean
2746822|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months|difference in mean|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.|||grams/cm^2||Standard Deviation|Mean
2746823|NCT00903344|Secondary|Change in Bone Mineral Density (BMD) at HIP at 3 Months||Change from Baseline to 3 months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.|||grams/cm^2||Standard Deviation|Mean
2746824|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 6 Months||Change from Baseline to 6 Months||||ng/ml||Standard Deviation|Mean
2746825|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 3 Months|Difference in means between visits|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for two of the groups' participants was not included in the results.|||ng/ml||Standard Deviation|Mean
2746826|NCT00903344|Primary|Change in Bone Mineral Density (BMD) in HIP at 6 Months||Change from Baseline to 6 months||||grams/cm^2||Standard Deviation|Mean
2746827|NCT00903331|Secondary|Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study|"Disease worsening was indicated by pulmonary function test/idiopathic pulmonary fibrosis worsening (PFT/IPF) or acute respiratory decompensation of IPF.~PFT/IPF worsening was indicated by the occurrence of both of the following: confirmed by two tests at least 4 weeks apart, as defined by the occurrence of both of the following: decrease from baseline ≥ 10% in forced vital capacity and decrease from baseline ≥ 15% in corrected diffusing capacity of the lung for carbon monoxide.~Acute respiratory decompensation of IPF was defined as an unexplained rapid deterioration (over a period of less than 4 weeks) of the patient's condition with increasing shortness of breath requiring oxygen supplementation ≥ 5 L/min to maintain a resting oxygen saturation ≥ 90% or arterial oxygen pressure ≥ 55 mmHg (sea level) or 50 mmHg (high altitude)."|Up to end of study (Up to 24 months)|All randomized patients|||participants|||Number
2746828|NCT00903331|Primary|Forced Vital Capacity (FVC) at Baseline and End of Period 1|FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient's measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.|12 months|All randomized patients|||litres||95% Confidence Interval|Median
2746829|NCT00903201|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax)|Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL EDTA lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.|Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours|PK population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2746830|NCT00903201|Secondary|Maximum Observed Plasma Drug Concentration (Cmax)|Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL EDTA lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.|Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours|PK population. Only those participants available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2746831|NCT00903201|Secondary|Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t])|Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL Ethylenediaminetetraacetic acid (EDTA) lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.|Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours|PK Population which comprised of all participants in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed.|||Nanogram * hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2747751|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||pg/mL||Standard Deviation|Mean
2746832|NCT00903201|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) to Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||L||90% Confidence Interval|Mean
2746833|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D)|Blood samples intended for MMP-8 and MMP-9 analyses were collected in 4.0 mL lithium heparin greentopped collection tubes, then immediately mixed by gentle inversion five times. The samples were centrifuged at 1800 g for 15 minutes within 30 minutes of collection. A 2 mL volume of supernatant was transferred into a Sarstedt tube and subsequently centrifuged at 10000 g for 10 minutes at 2 to 8°C for complete platelet removal. A 1 mL volume of plasma supernatant was transferred into a Sarstedt tube and frozen at -70°C. Blood samples intended for SP-D were collected in 5.0 mL serum separator goldtopped blood collection tubes, then immediately mixed by gentle inversion 10 times. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 g for 15 minutes. Two 0.75 mL aliquots of serum supernatant were transferred separately into two Sarstedt tubes and frozen at -70°C. Plasma samples were centrally analyzed using a commercial test kit based on ELISA method.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2746834|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- Fibrinogen|Blood samples intended for fibrinogen analysis were collected in 4.5 mL 3.2 % sodium citrate blue-topped blood collection tubes, then immediately mixed by gentle inversion eight to ten times. Each sample was centrifuged at 1600 g for 15 minutes. A 1 mL volume of plasma supernatant was transferred via pipette into a Nunc tube, frozen at -20°C. Central analysis of fibrinogen in plasma samples was completed via photometric clot detection with automatic sample preparation.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed. One participant in the SB656933 20 mg arm had a fibrinogen reading on Day 14. This was not a planned visit schedule, therefore, fibrinogen levels were not analyzed for the placebo arm and SB656933 50 mg arm.|||Gram per liter||Geometric Coefficient of Variation|Geometric Mean
2746835|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- C-reactive Protein (CRP)|Blood samples intended for C-Reactive Protein (CRP) analysis were collected in 4.0 mL plain red-topped blood collection tubes. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 gram (g) for 15 minutes. A 1 mL volume of serum supernatant was transferred via pipette into a Nunc tube and stored at room temperature. Central analysis of CRP in serum samples was measured via fixed time nephelometry on the Behring Nephelometer II.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milligram per liter||Geometric Coefficient of Variation|Geometric Mean
2746836|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8])|Blood samples intended for CC-16 and CXCL8 were collected in 5.0 milliliter (mL) serum separator goldtopped blood collection tubes, then immediately mixed by gentle inversion 10 times. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 g for 15 minutes. Two 0.75 mL aliquots of serum supernatant were transferred separately into two Sarstedt tubes and frozen at -70 degree Celsius (°C). Plasma samples intended for CC-16 and CXCL8 were centrally analyzed using a commercial test kit based on enzyme-linked immunosorbent assay (ELISA) method.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2746837|NCT00903201|Secondary|Induced Sputum Inflammatory Markers-Myeloperoxidase and Neutrophil Elastase|Sputum samples were taken after bronchodilation. Mean induced sputum inflammatory markers namely Myeloperoxidase and neutrophil elastase are presented.|Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Nanogram/microgram||Geometric Coefficient of Variation|Geometric Mean
2746838|NCT00903201|Secondary|Induced Sputum Neutrophil Percentage|Sputum samples were taken after bronchodilation and percentage of neutrophils in induced sputum are presented.|Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Percentage of neutrophil cells||Standard Deviation|Mean
2746839|NCT00903201|Secondary|Induced Sputum Neutrophil Number|Sputum samples were taken after bronchodilation and number of neutrophils in induced sputum were reported.|Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^4 cells/gram||Geometric Coefficient of Variation|Geometric Mean
2746840|NCT00903201|Secondary|Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum|Bacterial colony count of both Pseudomonas aeruginosa and Staphylococcus aureus in sputum were performed. Participants were graded as no bacteria in sputum, 1+, 2+, 3+ and 4+, which indicated proportional concentration of Pseudomonas aeruginosa and Staphylococcus aureus in sputum, where no bacteria indicated there was no bacteria in sputum, 1+ indicated slightly positive and 4+ indicated highly positive. Higher grades (4+) indicated worst outcomes (highly infected sputum). Number of participants with Pseudomonas aeruginosa and staphylococcus aureus count in sputum are presented.|Day 1 and Day 28||||Participants|||Count of Participants
2746841|NCT00903201|Primary|Number of Participants With Cystic Fibrosis (CF) Exacerbation|CF is one of the most common, lethal, autosomal recessive disease characterized by airway obstruction, bronchiectasis and infection, and exocrine pancreatic insufficiency. Number of participants with CF exacerbation are presented.|Day 1 to Day 42|All Subjects Population.|||Participants|||Count of Participants
2746860|NCT00903162|Secondary|The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life.|OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.||||||
2746842|NCT00903201|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Prior to ECG recordings, all participants rested for at least 5 minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Participants avoided hot and cold food for at least 30 minutes prior to an ECG measurement. Any results falling outside normal range were repeated at the discretion of the Investigator. ECG Baseline values taken within 2.5 hours prior to first dose were calculated using the mean value of triplicate pre-dose readings. Triplicate readings were taken at least five minutes apart. Participants agreed to abstain from hot and cold drinks and food prior to an ECG measurement. ECG machine calculated heart rate and measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) electrocardiogram (ECG) findings are presented.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
2746843|NCT00903201|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|The potential clinical concern range for clinical chemistry parameters were: glucose (low: < 2.8 millimole [mmol]/L and high: > 9.4 mmol/L), creatine kinase (high: > 3 * upper limit of normal units [ULN]/L), phosphorous, inorganic (low: < 0.8 mmol/L and high: > 1.6 mmol/L), total bilirubin (high: ≥ 1.5 * ULN micromole [μmol]/L), uric acid (low: < 41.636 μmol/L and high: > 582.904 μmol/L), alkaline phosphatase (ALP) (high: ≥ 2 * ULN international units [IU/L]/L), gamma glutamyl transpeptidase (GGT) (high: ≥ 110 IU/L), carbon dioxide content (low: < 18 mmol/L and high: > 32 mmol/L), direct bilirubin (high: > 1.5 * ULN μmol/L), potassium (low: < 3.0 mmol/L and high: > 5.5 mmol/L) and aspartate aminotransferase (AST) (high: ≥ 3* ULN IU/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry abnormalities of potential clinical importance.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
2746844|NCT00903201|Primary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance|Hematology parameters were reviewed prior to participants receiving first dose of study medication. The potential clinical concern range for hematology parameters were: Red blood cell (RBC) count (low: < 3.72 * 10^12/Liters (L) and high: > 6.313 * 10^12/L), lymphocytes (low: < 0.8 gigacells/L), hematocrit (low: > 0.075 ratio change from Baseline and high: > 0.54 ratio), mean cell hemoglobin (MCH) (low: < 23.8 picograms (pg) and high: > 39.6 pg), mean cell volume (MCV) (low: <73 femtoliters (FL) and high: >110 FL), platelet count (low: < 100 gigacells/L and high: > 550 gigacells/L), white blood cell (WBC) count (low: < 3 gigacells/L and high: > 20 gigacells/L) and eosinophils (high: > 1 gigacells/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with hematology abnormalities of potential clinical importance are presented.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
2746845|NCT00903201|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital signs included heart rate, systolic and diastolic blood pressure and body temperature. Prior to vital signs all participants rested for at least five minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Any results falling outside the normal range were repeated at the discretion of the Investigator. Potential clinical concern range for systolic blood pressure: <85 and >160 millimeter of mercury (mmHg), for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
2746846|NCT00903201|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Follow-up (up to 42 days)|All Subjects population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2746847|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Mean
2746861|NCT00903162|Secondary|Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.|Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.||||||
2746863|NCT00903032|Primary|Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)|The primary outcome was the proportion of patients who were adherent to cardioprotective medications (beta-blockers, statins, clopidogrel, and ACE/ARB) in the year following ACS hospitalization.|12-months|Composite Adherence* (PDC>0.80) (%)|||percentage of participants|||Number
2746848|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746849|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746850|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746851|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 - by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746852|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning (PF) Scale of the EORTC QLQ-C30 - by First-Line (1L) Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746862|NCT00903162|Primary|Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.|The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.|1 year|Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity.|||participants|||Number
2746864|NCT00903006|Primary|Patient Response (+ Time to Disease Progression)||Baseline, after two 28 day cycles, until disease progression.|||||||
2746853|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First and Second-line Drugs Combined|The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L or 2-L treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746854|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First-line Drug|The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L of treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746855|NCT00903175|Secondary|Duration of Response (DoR) - First-Line (1-L)|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR) during the first-line treatment period. The start date was the date of first documented response (CR or PR) during the first-line treatment and the end date was the date of the event defined as the first documented progression or death due to underlying cancer during or after the same treatment line.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The analysis population corresponds to the patients included in the Full analysis set (i.e. randomized patients analyzed according to the treatment and stratum they were assigned to at randomization) and who achieved a best overall response of CR or PR during the first-line treatment period.|||Months||95% Confidence Interval|Median
2746856|NCT00903175|Secondary|Overall Response Rate (ORR) - First -Line (1-L)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) and was based on investigator assessment of radiology data per RECIST. Participants with best overall response of 'Unknown' were treated as non-responders in the calculation of the ORR. Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||percentage of participants|||Number
2746857|NCT00903175|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. The analysis of OS included all deaths in the FAS regardless of when they were observed.|Every 2 months from randomization up to 3 years after last patient randomized|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746858|NCT00903175|Secondary|Progression-free Survival Combined (PFS-C)|PFS-C (1L and 2L study drugs combined) was a composite endpoint which combined both lines of study treatment. It was defined as the time from the date of randomization to the first of the following: date of death due to any cause, or date of the first radiologically documented progression disease during or after the second-line treatment period for patients with a radiologically documented progression disease in the first-line treatment period and who had crossed-over to second-line treatment no more than 6 weeks after progression.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to about 56 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746859|NCT00903175|Primary|Progression Free Survival First-Line (PFS 1-L)|PFS_1L based on investigator assessment of radiology data by RECIST 1.0, was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause during or after first-line treatment with everolimus or sunitinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2746944|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy|Simple correlations will be computed at Baseline Chemotherapy for symptoms.|Baseline||||correlation coefficient|||Number
2746865|NCT00903006|Primary|Phase I Maximum Tolerated Dose (MTD) for Dose Level 1|"Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels:~Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle.~MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1)~Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily"|28 day cycle|Study terminated early; Analysis not available due to smaller sample size.||||||
2746866|NCT00902850|Primary|Clinical Performance|Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.|Insertion, 4 hours & End of Day|All eligible participants|||units on a scale|||Number
2746867|NCT00902746|Secondary|Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.|||units on a scale||Standard Deviation|Mean
2746868|NCT00902746|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.|||units on a scale||Standard Deviation|Mean
2746869|NCT00902668|Primary|Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy|Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale|during the first 5 years after treatment|Due to slow accrual the study was closed to accrual and all 3 participants were terminated. No data was analyzed.||||||
2746870|NCT00902577|Other Pre-specified|Summary of Mean and Median Ktrans Across Participants.|"ktrans is a measure of vascular permeability and reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage), which can be represented by the mean or median rate.~Mean & Median ktrans within subject were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~The mean across subjects is presented below (Mean (Mean-ktrans) and Mean(Median-Ktrans))"|baseline|Evaluable patients with usable FMISO\PET and DCE\MRI|||1/min||Standard Deviation|Mean
2746871|NCT00902577|Other Pre-specified|Normalized Relative Cerebral Blood Volume (nRCBV) and Normalized Cerebral Blood Flow (nCBF)|Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature Cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter (nCBF); nCBF provides a measure of vascular permeability and perfusion|baseline|Evaluable participants with both usable FMISO\PET and DSC\MRI.|||ratio||Standard Deviation|Mean
2746872|NCT00902577|Other Pre-specified|DWI Apparent Diffusion Coefficient (ADC)|"Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue (mm^2/s). Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area.~A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower and the mean of the higher ADC curves were evaluated"|baseline|Participants having a usable FMISO\PET and DWI\MRI scans|||mm^2/s||Standard Deviation|Mean
2746873|NCT00902577|Other Pre-specified|Hypoxic Volume as a Measure of Tumor Hypoxia|"The hypoxic volume (HV) was determined as the volume of pixels in the tumor on in the FMISO\PET with a tumor to blood activity ratio ≥ 1.2.~HV is a measure of the spatial extent of tumor hypoxia (in milliliters)"|baseline||||milliliters||Standard Deviation|Mean
2746874|NCT00902577|Other Pre-specified|SUVpeak and T/Bmax as Measures of Tumor Hypoxia|"The FMISO image data were normalized by the average blood activity to produce pixel level tissue-to-blood ratio (T/B) values for all image slices. And the severity of the hypoxia was determined by the pixel with the maximum T/B value (TBmax).~FMISO SUVpeak was determined as the average SUV from a 1 cm circular ROI centered over the hottest pixel. Since FMISO selectively binds to hypoxic tissues, SUVpeak within a region provides a measure of tumor hypoxia."|baseline||||ratio||Standard Deviation|Mean
2746875|NCT00902577|Other Pre-specified|Overall and Progression Free Survival|Disease progression was defined by Macdonald criteria. Survival and Progression were evaluated every 3months and at the end of study (up to 5 years) and time to event evaluated.|Baseline, every 3 months through study completion (up to 5 years for progression and survivorship)||||days||95% Confidence Interval|Median
2746876|NCT00902577|Secondary|Correlation Between MRS Markers and MR Imaging Markers of Vascularity as Well as Between MRS Markers and PET Markers of Tumor Hypoxia|"Correlation between MRS markers and MR imaging markers and PET markers of tumor hypoxia~MRS markers include:~NAA/Cho, Cho/Cr, Lac/Cr, and Lac/NAA measured within tumor and at the periphery.~MR imaging markers of vascularity include: CBV, CBF, and ktrans PET tumor hypoxia marker: SUVmax"|baseline|Seventeen participants from four sites had analyzable 3D MRSI datasets acquired on Philips, GE or Siemens scanners at either 1.5T or 3T. MRSI data were analyzed using LCModel to quantify metabolites N-acetylaspartate (NAA), creatine (Cr), choline (Cho), and lactate (Lac)|||correlation coefficient|||Number
2746877|NCT00902577|Secondary|Correlation Between T/Cmax and T/Bmax|Pearson correlation coefficient will be used to quantify the correlation between T/Bmax, the maximum tissue-to-blood ratio activity value, and T/Cmax, the tissue-to-cerebellum activite value Since T/Cmax does not requiring blood sampling and is image derived, a high correlation would indicate that T/Cmax could be an advantageous surrogate for T/Bmax.|At baseline||||correlation coefficient|||Number
2746878|NCT00902577|Secondary|"Reproducibility of the Baseline FMISO PET Uptake Parameters as Assessed by Baseline Test and Retest PET Scans"|"Reproducibility, defined as the variation of repeated measurements in an experiment performed under the same conditions, will be measured as the within subject coefficient of variation with upper an lower repeatability coefficients (LRC, URC) computed as percents from log-transformed data, per Velaquez, et al (J Nucl Med. 2009 Oct;50(10):1646-54. doi: 10.2967/jnumed.109.063347. Epub 2009 Sep 16. PMID: 19759105 ).~Where Within Subject Coefficient of Variation (wCV) is a percentage defined as wCV(%)=100* (exp( SD[ld]/√2) - 1)~and LRC and URC are calculated as: RC=100 (exp(±1.96 SD[ld]) -1).~here SD[ld] is the standard deviation of the difference of the log-transformed PET measurements. These bounds provide an estimate of the lower and upper bounds of percent change observed between scans for each measurement."|Baseline and retest within 1 to 7 days after (but prior to the start of therapy)|Analysis will be performed SUVmax and SUV Peak, average and maximum values, across patients and by target tumor.|||Within Subj. Coefficient of Variation %||95% Confidence Interval|Number
2746879|NCT00902577|Secondary|Association of Baseline FMISO PET and MRI Features With Time-to-Progression (TTP)|"Disease progression was defined by Macdonald criteria. PFS was evaluated every 3months through the end of study (up to 5yrs), features were measured at baseline.~Quantitative imaging features measuring abnormal tumor vasculature (MRI) and hypoxia (FMISO) were evaluated for their association with TTP (cox model) and to discriminate between responders and non-responders at 6 and 9 mos (PFS6 and PFS9) (logistic) Features include~PET Hypoxia measures:~Peak standardized uptake values (SUVpeak); maximum tumor:blood ratio (T/Bmax); and Hypoxia Volume (HV)~DCE MRI perfusion measures:~Mean/median volume transfer constant for gadolinium between blood plasma and the tissue extravascular extracellular space (ktrans)~DSC MRI tumor vasculature:~Normalized Relative cerebral blood volume (nRCBV); and Cerebral blood flow (CBF)~DWI MRI magnitude of diffusion of water through tissue (cell density):~Apparent diffusion coefficient (ADC) using low and high Gaussian distributions"|assessed from baseline up to 5 years, progression status at months 6 and 9 reported||||Participants|||Count of Participants
2746880|NCT00902577|Primary|Association of Baseline FMISO PET and MRI Features With OS as Assessed Using Cox-regression Model|"Overall Survival (OS) was evaluated every 3 months through end of the study (up to 5 years). A variety of continuous quantitative (functional) imaging features measuring abnormal tumor vasculature (MRI) and hypoxia (FMISO) were evaluated at baseline for their association with Survival time.~Features include~PET Hypoxia measures:~Peak standardized uptake values (SUVpeak); maximum tumor:blood ratio (T/Bmax); and Hypoxia Volume (HV)~DCE MRI perfusion measures:~Mean/median volume transfer constant for gadolinium between blood plasma and the tissue extravascular extracellular space (ktrans)~DSC MRI tumor vasculature:~Normalized Relative cerebral blood volume (nRCBV); and Cerebral blood flow (CBF)~DWI MRI magnitude of diffusion of water through tissue (cell density):~Apparent diffusion coefficient (ADC) using low and high Gaussian distributions"|"assessed from baseline up to 5 years, survival status at 1-year reported"|FMISO-PET identifies the primary analysis population containing participants with interpretable FMISO images.The Evaluable study population consisted of enrolled GBM patients having an FMISO-PET procedure. Additional groups include functional MRI, with available/interpretable images.|||Participants|||Count of Participants
2746881|NCT00902564|Secondary|Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks|Observed Cases (OC)|||percentage of patients|||Number
2746882|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
2746883|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
2746884|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
2746885|NCT00902564|Secondary|Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks||||percentage of patients|||Number
2746886|NCT00902564|Secondary|Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks||||percentage of patients|||Number
2746887|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
2746888|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
2746889|NCT00902564|Primary|Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
2746890|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
2746891|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
2746892|NCT00902538|Secondary|In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||Participants|||Number
2746893|NCT00902538|Secondary|In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
2746894|NCT00902538|Secondary|In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
2746895|NCT00902538|Secondary|Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
2746896|NCT00902538|Secondary|Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
2746897|NCT00902538|Secondary|Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.|Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|baseline (week 8) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||Participants|||Number
2746898|NCT00902538|Secondary|Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
2746899|NCT00902538|Primary|Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
2746900|NCT00902486|Secondary|Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746901|NCT00902486|Secondary|Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24|"Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as most imaginable pain. MCID for the pain score is a decrease of at least 10 mm on a 100 mm scale."|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746902|NCT00902486|Secondary|Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The MCID score for HAQ-DI is -0.22.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746903|NCT00902486|Secondary|Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||scores on a scale||Standard Deviation|Mean
2746904|NCT00902486|Secondary|Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||scores on a scale||Standard Deviation|Mean
2746905|NCT00902486|Secondary|Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.|Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746906|NCT00902486|Secondary|Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.|Week 12|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746907|NCT00902486|Secondary|Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.|Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746908|NCT00902486|Secondary|Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.|Week 12|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746909|NCT00902486|Secondary|Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Minutes||Standard Deviation|Mean
2746910|NCT00902486|Secondary|Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||mg/L||Standard Deviation|Mean
2746911|NCT00902486|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||mm/hr||Standard Deviation|Mean
2746912|NCT00902486|Secondary|Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Score on a scale||Standard Deviation|Mean
2746913|NCT00902486|Secondary|Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24|"Physicians were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no arthritis activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as extremely active arthritis (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement."|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||millimeter (mm)||Standard Deviation|Mean
2746914|NCT00902486|Secondary|Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24|"Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no arthritis activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as extremely active arthritis (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement."|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||millimeter (mm)||Standard Deviation|Mean
2746915|NCT00902486|Secondary|Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24|"Participants were to assess their current level of pain on a 100 mm horizontal Visual Analog Scale (VAS). The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as most imaginable pain."|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||millimeter (mm)||Standard Deviation|Mean
2746916|NCT00902486|Secondary|Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Swollen joints||Standard Deviation|Mean
2746917|NCT00902486|Secondary|Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Tender joints||Standard Deviation|Mean
2746918|NCT00902486|Secondary|Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6|Participants who achieved inactive disease based on DAS 28 CRP (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746919|NCT00902486|Secondary|Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6|Participants who achieved inactive disease based on the DAS 28 ESR (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746920|NCT00902486|Secondary|Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2|Participants who achieved low disease activity based on the DAS 28 ESR (score ≤3.2). Participants who achieved low disease activity were classified as responders in this analysis.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746921|NCT00902486|Secondary|Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Units on a scale||Standard Deviation|Mean
2746922|NCT00902486|Secondary|Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Units on a scale||Standard Deviation|Mean
2746923|NCT00902486|Secondary|The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24|The ACR 90 is defined greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746924|NCT00902486|Secondary|The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24|The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746925|NCT00902486|Secondary|The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24|The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.|Week 12 and Week 24|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||percentage of participants|||Number
2746926|NCT00902486|Secondary|The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24|The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.|From Baseline to Week 24|Modified Intent-to-Treat (mITT) population included all participants who were assigned to active treatment at baseline and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Participants|||Count of Participants
2746927|NCT00902486|Secondary|Participants With at Least 1 Adverse Event From Week 12 to Week 24||Week 12 to Week 24|Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.|||Participants|||Count of Participants
2746928|NCT00902486|Primary|Participants With at Least 1 Adverse Event From Baseline Through Week 12||From Baseline through week 12|Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.|||Participants|||Count of Participants
2746929|NCT00902486|Primary|The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement|The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.|Week 12|Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.|||Participants|||Count of Participants
2746930|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at End of Chemotherapy for quality of life scores.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||correlation coefficient|||Number
2746963|NCT00902278|Secondary|Antibody Responses Following Immunization|Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group|Prevaccination and approximately 1 month post vaccination|Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for the flulaval group. Only participants with evaluable data were included in this analysis.|||fold change||95% Confidence Interval|Geometric Mean
2746931|NCT00902330|Secondary|Effects of Treatment on Quality of Life - Means at End of Treatment|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|up to 2 weeks after completion of study treatment, for up to 8 months||||units on a scale||Standard Error|Least Squares Mean
2746932|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at end of Chemotherapy for symptoms.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||correlation coefficient|||Number
2746933|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||units on a scale||Standard Deviation|Mean
2746934|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment|Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||correlation coefficient|||Number
2746935|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks after completion of study treatment, for up to 8 months||||Log (pg/ml)||Standard Deviation|Mean
2746936|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.|Midpoint Chemotherapy, up to 4 months||||correlation coefficient|||Number
2746937|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Midpoint Chemotherapy, up to 4 months||||units on a scale||Standard Deviation|Mean
2746938|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for symptoms.|Midpoint Chemotherapy, up to 4 months||||correlation coefficient|||Number
2746939|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Midpoint Chemotherapy, up to 4 months||||units on a scale||Standard Deviation|Mean
2746940|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months||||correlation coefficient|||Number
2746941|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months||||Log (pg/ml)||Standard Deviation|Mean
2746942|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Baseline|Simple correlations will be computed at Baseline for quality of life scores.|Baseline||||correlation coefficient|||Number
2746943|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Baseline|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Baseline||||units on a scale||Standard Deviation|Mean
2746945|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Baseline||||units on a scale||Standard Deviation|Mean
2746946|NCT00902330|Secondary|Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline||||correlation coefficient|||Number
2746947|NCT00902330|Secondary|Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline|Per protocol, for all subjects with available data. No imputation was utilized.|||Log(pg/ml)||Standard Deviation|Mean
2746948|NCT00902330|Secondary|To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.|Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported.|up to 2 weeks after completion of study treatment, for up to 8 months||||Rotated factor loading multiplied by 100|||Number
2746949|NCT00902330|Primary|Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer|Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire|Up to 2 weeks afer completion of study treatment, for up to 8 months||||units on a scale||Standard Deviation|Least Squares Mean
2746950|NCT00902304|Secondary|Number of Patients With Major Clinical Endpoints|Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.|||participants|||Number
2746951|NCT00902304|Secondary|Rate of Treatment Compliance|The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance).|26 weeks|This data will not be analyzed due to the poor quality of the data.||||||
2746952|NCT00902304|Secondary|Change in Self-care Behavior Score From Baseline to Week 26|A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||Change in score||Standard Deviation|Mean
2746953|NCT00902304|Secondary|Participants With End Organ Disease at Baseline and Week 26|"A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).~Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.~It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks)."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.|||participants|||Number
2747029|NCT00901576|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
2746954|NCT00902304|Secondary|Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26|"The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.~The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||change in CES-D score||Standard Deviation|Mean
2746955|NCT00902304|Secondary|Number of Patients With Depression|Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||participants|||Number
2746956|NCT00902304|Secondary|Change in the EQ-5D Score|The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||change in EQ-5D score||95% Confidence Interval|Mean
2746957|NCT00902304|Secondary|Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments|A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.|||Participants|||Number
2746958|NCT00902304|Secondary|Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy|The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset.|26 weeks|Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment.|||participants|||Number
2746959|NCT00902304|Secondary|Change in Absolute Cardiovascular Risk Score|"The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.~A decrease indicates improvement."|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||percentage risk score change||Standard Deviation|Mean
2746960|NCT00902304|Secondary|Change in Mean Sitting Diastolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
2746961|NCT00902304|Secondary|Change in Mean Sitting Systolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
2746962|NCT00902304|Primary|Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target|BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.|||percentage of participants|||Number
2748338|NCT00887978|Post-Hoc|6-minute Walk Distance by PAH Etiology: Idiopathic PAH (IPAH) / Heritable PAH(HPAH)|Covariate analysis of change in 6MWD by PAH etiology, specifically idiopathic or heritable PAH|Baseline and 16 Weeks|Subjects with IPAH/HPAH|||meters||Inter-Quartile Range|Median
2746964|NCT00902278|Primary|T Cell Responses Following Immunization|Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups|Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination|Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for Flulaval group.Only participants with evaluable data were included in the analysis.|||fold change||Standard Deviation|Mean
2746965|NCT00902265|Secondary|Participants With Treatment Emergent Adverse Events (AEs)||Week 1 to Week 12|Safety Population, consisting of participants who took at least one dose of desmopressin|||Participants|||Number
2746966|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
2746967|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
2746968|NCT00902265|Secondary|Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12|The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
2746969|NCT00902265|Secondary|Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
2746970|NCT00902265|Secondary|Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||Units on a scale||Standard Deviation|Mean
2746971|NCT00902265|Secondary|Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12|Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 - baseline.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||Hours||Standard Deviation|Mean
2746972|NCT00902265|Secondary|Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12|The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||ratio||Standard Deviation|Mean
2746973|NCT00902265|Primary|Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12|The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||Number of nocturnal voids||Standard Deviation|Mean
2746974|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
2746975|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
2746976|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.|||scores on a scale||Standard Deviation|Mean
2746977|NCT00902226|Secondary|Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks||||percentage of patients|||Number
2746978|NCT00902226|Secondary|Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks||||percentage of patients|||Number
2746979|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
2746980|NCT00902226|Primary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
2746981|NCT00902174|Secondary|Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.~The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.|||ng/mL||Standard Deviation|Mean
2746982|NCT00902174|Secondary|Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.~The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.|||ng/mL||Standard Deviation|Mean
2746983|NCT00902174|Secondary|Covariance of End of Study CAMPHOR Score|The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.|Week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Error|Least Squares Mean
2746984|NCT00902174|Secondary|Change in Borg Dyspnea Score During 6-minute Walk Test|Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.|week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Deviation|Mean
2746985|NCT00902174|Secondary|Change From Baseline in Heart Rate|Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||bpm||Standard Error|Least Squares Mean
2746986|NCT00902174|Secondary|Change From Baseline in Diastolic Arterial Blood Pressure|Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
2746987|NCT00902174|Secondary|Change From Baseline in Systolic Arterial Blood Pressure|Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
2746988|NCT00902174|Secondary|Change From Baseline in Cardiac Output|Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters/minute||Standard Error|Least Squares Mean
2746989|NCT00902174|Secondary|Change From Baseline in Pulmonary Resistance Index|Change from baseline in pulmonary resistance index (dynes*sec*cm^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||dynes*sec*cm^-5/m2||Standard Error|Least Squares Mean
2746990|NCT00902174|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Change from baseline in pulmonary vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||dynes*sec*cm^-5||Standard Error|Least Squares Mean
2746991|NCT00902174|Secondary|Change From Baseline in Systemic Vascular Resistance|Change from baseline in systemic vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||dynes*sec*cm^-5||Standard Error|Least Squares Mean
2746992|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Capillary Wedge Pressure|Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
2746993|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure|Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis|||mm Hg||Standard Error|Least Squares Mean
2746994|NCT00902174|Secondary|Change From Baseline in Right Atrial Pressure|Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
2746995|NCT00902174|Secondary|Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases|Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.|24 weeks|The Full Analysis Set included all participants who received at least one dose of study drug and experienced an adjudicated event. A cox regression analysis model was used.|||percentage of participants|||Number
2746996|NCT00902174|Primary|Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks|This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.|24 weeks|The Full Analysis Set includes all participants who received at least one dose of study drug and completed the 6MWD Six-minute walk test at week 24. Repeated measurement model was used for this analysis.|||meters||Standard Error|Least Squares Mean
2746997|NCT00902161|Secondary|Number of Participants Who Discontinued Study Treatment Due To AEs|"An AE was defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)|All treated participants|||participants|||Number
2746998|NCT00902161|Secondary|Number of Participants With An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).|All treated participants|||participants|||Number
2748921|NCT00884273|Secondary|Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8|TRUS is a method of measuring the size of the prostate.|After treatment of 4 and 8 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).|||milliliter||Standard Deviation|Mean
2746999|NCT00902161|Secondary|Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893|Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve|From time of MK0893 administration through estimated 32 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.|||nM||Standard Deviation|Mean
2747000|NCT00902161|Secondary|Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893|"Cmax was the maximum or peak concentration of MK0893 observed after its administration.~Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4"|From time of MK0893 administration through 24 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.|||uM||Standard Deviation|Mean
2747001|NCT00902161|Primary|Recovery Time (Rt[65] From Insulin-induced Hypoglycemia|Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes|From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes|21 participants who received MK0893 + Propanolol while on study had data available, and 17 participants who received Placebo + Propanolol while on study had data available|||minutes||95% Confidence Interval|Least Squares Mean
2747002|NCT00902018|Other Pre-specified|Change From Baseline After Eltrombopag Treatment of Platelet Parameters|"Samples were drawn weekly for 2 weeks on days 1, 8, and 15 for the treatment arms and day 1 for the healthy control group. Platelet samples were exposed to small molecule Bcl-xL inhibitor, ABT-737 ex-vivo to explore resistance to apoptosis by determining the half maximal inhibitory concentration (IC50) which was measured for each weekly sample drawn. If the half maximal concentration of ABT737 was increased this meant increased resistance to apoptosis.~The AKT pathway intermediates were measured since these would indicate the mechanism of the platelet resistance to apoptosis so the two sets of measures confirm each other the AIPF is a measure of how many new platelets are made and the large platelets are similar to that"|testing on days 8 and 15|0 participants were analyzed in the healthy controls arm because healthy controls did not have any blood draw on day 8 and 15 or receive the intervention and hence data was not collected for these participants|||Participants|||Count of Participants
2747003|NCT00902018|Secondary|How Many Patients Developed SAEs and/or Abnormal Liver Tests to a Level > 2 Times the Upper Limit of Normal|To assess the safety of eltrombopag, in particular the number of patients with serious adverse events and/or abnormal liver tests reaching a level of more than twice the upper limit of normal for the test these outcomes were assessed periodically for liver tests but other SAEs were not systematically assessed but only with complaints or events|on days 8 and 15|0 participants were analyzed in the healthy controls arm because healthy controls did not have any blood draw on day 8 and 15 or receive the intervention and hence data was not collected for these participants|||participants|||Number
2747004|NCT00902018|Primary|Number of Patients Who Received Romiplostim and Increased Their Platelet Counts to > 50,000/uL|number of participants in whom platelet counts measured on day 8 and day 15 after treatment(s) with romiplostim 10 micrograms/kg on days 1 and 8|platelet counts on days 8 and 15||||participants|||Number
2747005|NCT00902018|Primary|Number of Patients for Whom Eltrombopag Increases the Platelet Count to > 50,000/uL|number of patients in whom Platelet Counts measured on days 8 and 15 after eltrombopag treatment increase to > 50,000/uL counts on other days are just used to be sure the ones on days 8 and 15 are reasonably accurate and representative|platelet counts on days 8 and 15|0 participants were analyzed in the healthy control arm because healthy controls did not have any blood draws on day 8 and 15 or receive the intervention and hence data was not collected for these participants|||participants|||Number
2747006|NCT00901927|Secondary|Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 months||||months||Full Range|Median
2747007|NCT00901927|Secondary|Participants With Adverse Events|To evaluate the toxicity and safety of BMR in participants with untreated follicular lymphoma.|3 months||||Participants|||Count of Participants
2747008|NCT00901927|Primary|Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)|To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.|3 months||||participants|||Number
2747009|NCT00901901|Other Pre-specified|Tumor Response|Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants|||Participants|||Number
2747010|NCT00901901|Other Pre-specified|Time to Response|Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Time to response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.|||Days||95% Confidence Interval|Median
2747164|NCT00899470|Primary|Metformin Mean AUC(0-INF)|AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
2747011|NCT00901901|Other Pre-specified|Duration of Response|Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Duration of response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.|||Days||95% Confidence Interval|Median
2747012|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS|Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.|The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2747013|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index|The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.|The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2747014|NCT00901901|Secondary|Disease Control|Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants|||Participants|||Number
2747015|NCT00901901|Secondary|Time to Radiological Tumor Progression (TTP)|TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants|||Days||95% Confidence Interval|Median
2747016|NCT00901901|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.|From randomization of the first patient until 34 months or date of death of any cause whichever came first|The full analysis set (FAS), which was defined as all randomized participants|||Days||95% Confidence Interval|Median
2747017|NCT00901628|Secondary|Maximal Flexion Angle Degree on Postoperative 7 Day|An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day|postoperative 7 day||||degree||Standard Deviation|Mean
2747018|NCT00901628|Secondary|The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended||24 hours postoperative||||participants|||Number
2747019|NCT00901628|Secondary|the Proportion of Patients Who Were Satisfied With the Pain Management||postoperative 7 day||||participants|||Number
2747020|NCT00901628|Secondary|Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery|An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.|24 hours after surgery||||participants|||Number
2747021|NCT00901628|Secondary|Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery|Fentanyl based PCA consumption via PCA pump (microgram)|24 hours postoperative||||microgram||Standard Deviation|Mean
2747022|NCT00901628|Primary|Pain( Visual Analog Scale )|An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.|the night after surgery||||units on a scale||Standard Deviation|Mean
2747023|NCT00901576|Primary|T 1/2 of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2747024|NCT00901576|Primary|Tmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2747025|NCT00901576|Primary|AUC of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
2747026|NCT00901576|Primary|Cmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng/ml||Standard Deviation|Mean
2747027|NCT00901576|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2747028|NCT00901576|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
2747030|NCT00901576|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-methylphenidate. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
2747031|NCT00901459|Secondary|Change in Craving for Cigarettes After Controlled Smoke Presentations.|"Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire (Did it immediately reduce your craving for cigarettes?) after smoking presentations through the controlled puff volume apparatus."|After smoking a cigarette through the controlled puff volume apparatus during rTMS||||units on a scale||Standard Deviation|Mean
2747032|NCT00901459|Primary|Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.|"Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING (urges to smoke, miss a cigarette, and crave cigarettes), MOOD (calm, tense, and irritable), AROUSAL (wide awake, able to concentrate), and HUNGER (feel hungry). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving."|Following exposure to in vivo cues|A repeated measures design exposed participants to three different rTMS conditions over 3 separate visits, with order counterbalanced using latin square design.|||units on a scale||Standard Error|Mean
2747033|NCT00901342|Primary|Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)||Day 0 (first infusion) and up to 3 infusions at 2-week intervals|Participants who Received At least 1 Infusion|||participants|||Number
2747034|NCT00901316|Primary|Medically Attended Skin and Soft Tissue Infections (MA-SSI)|Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.|From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.||||percentage of partipants||95% Confidence Interval|Number
2747035|NCT00901303|Primary|36-Month Progression-free Survival Rate|Progression-free survival is defined as the length of time from study intervention to disease progression or death|36 months|Data was not collected due to early termination of the study.||||||
2747036|NCT00901225|Secondary|Platelet Engraftment|Days to platelet count >20,000|12 months||||days||Full Range|Median
2747037|NCT00901225|Secondary|Number of Subjects Experiencing Durability of Engraftment|Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.|12 months||||participants|||Number
2747038|NCT00901225|Secondary|Days to Absolute Neutrophil Count >500||12 months||||days||Full Range|Median
2747039|NCT00901225|Secondary|Number of Subjects Experiencing Graft Failure|To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).|12 months||||participants|||Number
2747040|NCT00901225|Secondary|Number of Participants Experiencing a Grade III/IV Toxicity|Safety of plerixafor as measured by Grade III/IV Toxicity|6 months post transplant or until relapse||||participants|||Number
2747041|NCT00901225|Primary|Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.||5 days after receiving G-CSF||||participants|||Number
2747042|NCT00901186|Secondary|Percentage of CRT Change From Baseline by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.|||Percentage change||Standard Deviation|Mean
2747043|NCT00901186|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.|||micrometers||Standard Deviation|Mean
2747044|NCT00901186|Secondary|Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.|VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.|||Percentage of participants|||Number
2747045|NCT00901186|Secondary|Evolution of Mean Change From Baseline in BCVA by Study Visit|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month BCVA values were included in the analysis.|||letters||Standard Deviation|Mean
2747046|NCT00901186|Secondary|Percentage of Participants With Improvement in BCVA|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.|||Percentage of participants|||Number
2747047|NCT00901186|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, 12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. Participants who had both Baseline and Month 12 BCVA values only were included in this analysis.|||letters||Standard Deviation|Mean
2747048|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|12 months||||% of implants|||Number
2747049|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility (based on hand testing)~Absence of a peri-implant infection with suppuration.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|12 months||||% of implants|||Number
2747050|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|6 Months||||% of implants|||Number
2747051|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility (based on hand testing)~Absence of a peri-implant infection with suppuration.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|6 months||||% of implants|||Number
2747052|NCT00901017|Primary|Change of Vertical Height of Buccal Defects|Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery|Baseline to 26 weeks|14 patients represented the ITT population.|||mm||95% Confidence Interval|Mean
2747053|NCT00900822|Secondary|Implant Success Rate|Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.|12 months after loading the implant||||percentage of implants|||Number
2747054|NCT00900822|Primary|Histologically Measured Bone to Implant Contact (BIC)|Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone|9 months after implant placement|This was a split-mouth design. Each patient received both treatments. There was one sample in the Straumann BoneCeramic group that could not be analyzed.|||percentage of total surface||Standard Deviation|Mean
2747055|NCT00900822|Secondary|Implant Survival Rate|The percentage of implants remaining in the jaw.|12 months after loading the implant||||percentage of implants|||Number
2747056|NCT00900796|Secondary|Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by ASAS 40 and who received second anti-TNF treatment for at least 16 weeks (Phase 2).|||percentage of participants|||Number
2747057|NCT00900796|Secondary|Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy||Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2747161|NCT00899470|Secondary|BMS-510849 Mean AUC (0-T)|AUC (0-T) for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administration as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
2747058|NCT00900796|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).|||percentage of participants||95% Confidence Interval|Number
2747059|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.|Week 16|Analysis population included all participants enrolled in study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting first anti-TNF treatment (Phase 1). N (number of participants analyzed) signifies those participants who had low probability of response and were evaluable for the measure.|||percentage of participants||95% Confidence Interval|Number
2747060|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.|Week 32|Data was not analyzed as no participant met the criteria for low probability of response in phase 2 of the study.|||percentage of participants||95% Confidence Interval|Number
2747061|NCT00900796|Secondary|Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment|High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by the investigator and who received second anti-TNF treatment for at least 16 weeks (Phase 2).|||percentage of participants||95% Confidence Interval|Number
2747062|NCT00900796|Primary|Percentage of Participants With a Clinical Response|Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).|||percentage of participants||95% Confidence Interval|Number
2747063|NCT00900757|Secondary|Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks||||percentage of participants|||Number
2747064|NCT00900757|Secondary|Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks||||percentage of participants|||Number
2747065|NCT00900757|Secondary|Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment|The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.|6 weeks||||units on a scale||95% Confidence Interval|Mean
2747066|NCT00900757|Secondary|Complete Response|The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).|6 weeks||||percentage of participants||95% Confidence Interval|Number
2747067|NCT00900757|Primary|Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity|The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.|6 weeks||||participants|||Number
2747068|NCT00900731|Secondary|Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment|A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Up to 12 weeks|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.|||Percentage of days||Standard Error|Least Squares Mean
2747069|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.|||Puffs||Standard Error|Least Squares Mean
2747070|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.|||Puffs||Standard Error|Least Squares Mean
2747071|NCT00900731|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.|||Puffs||Standard Error|Least Squares Mean
2747072|NCT00900731|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.|||Score on a scale||Standard Error|Least Squares Mean
2747073|NCT00900731|Secondary|Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.|||Score on a scale||Standard Error|Least Squares Mean
2747074|NCT00900731|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|5 minutes to 4 hours post-dose at the end of treatment (week 12)|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure.|||Liter||Standard Error|Least Squares Mean
2747162|NCT00899470|Secondary|BMS-510849 Mean Cmax|Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng/mL||Standard Deviation|Mean
2747075|NCT00900731|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|End of treatment (Week 12)|Per-protocol population included all participants who received at least one dose of study medication without any major protocol deviations. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data were imputed using last observation carried forward.|||Liters||Standard Error|Least Squares Mean
2747076|NCT00900666|Secondary|Gait Function (Based on 6-Minute Walk)|Average walking speed as calculated during a 6-min walk|baseline, 1-mo and 4-mo post-injection|intention to treat|||meters/sec||Standard Deviation|Mean
2747077|NCT00900666|Primary|Mean Peak Knee Flexion During Swing Phase of Gait|Measured via computerized gait analysis, the average of peak knee flexion during swing phase.|baseline, 1-month and 4-month post-injection||||degrees||Standard Deviation|Mean
2747078|NCT00900627|Secondary|Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The time from the date of randomization until the date of death due to any cause.|Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012|Full Analysis Set|||Months|Participants|Inter-Quartile Range|Median
2747079|NCT00900627|Secondary|Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Evaluable for response set (EFR set is all FAS patients with measureable disease at baseline)|||Participants|||Number
2747080|NCT00900627|Primary|Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Full Analysis Set|||Months|Participants|Inter-Quartile Range|Median
2747081|NCT00900627|Primary|Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel|DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.|Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant|Safety population (all participants who received at least one dose)|||Number of Dose Limiting Toxicities|||Number
2747082|NCT00900601|Secondary|Healing Measured by CT|Number of participants with healing as measured by CT data. The outcome was radiological healing vs no signs of radiological healing. In order to be classified as healed the CT scans had to show Clear signs of bone bridging across the sacroiliac joint.|12 months||||Participants|||Count of Participants
2747083|NCT00900601|Primary|Visual Analogue Scale (VAS) 0 to 10|Visual Analogue Scale is a 0 -10 scale. Zero is no pain and 10 is the worst pain you can imagine. In this study the patients were asked to report the morgning and evening pain by this scale.|12 months||||units on a scale||95% Confidence Interval|Mean
2747084|NCT00900601|Primary|Oswestry Disability Index (ODI)|Oswestry Disability Index is a 10 item questionnaire comprises 10 questions about physical function. Each item has a 0-5 scale and the raw score is multiplied by 2 and the sum is the total score. Zero represents excellent physical function and 100 is more or less bedridden. This is the most used outcome measure in low back pain studies.|12 months||||units on a scale||95% Confidence Interval|Mean
2747085|NCT00900237|Primary|AUC0-t AUC From Time Zero to the Last Sampling Time|AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h||||ng.h/mL||Standard Deviation|Mean
2747086|NCT00900237|Primary|Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid|Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h||||ng/mL||Standard Deviation|Mean
2747087|NCT00900159|Secondary|Sleep-dependent Memory Consolidation|A computer-based Word-pair tasks is the number of words recalled after sleep from a list of words shown prior to going to sleep.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts||||words||Standard Deviation|Mean
2747163|NCT00899470|Primary|Metformin T-half and T-max|T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||hours||Standard Deviation|Mean
2747088|NCT00900159|Secondary|Objective Vigilance Task Performance|"A computer-based Flanker Task elicits responses to an incongruent pairing of stimuli measured as reaction time, in milliseconds. The Flanker task tests response inhibition, or the participants suppression of an unwanted response. A target stimulus (symbol) is flanked by non-target stimuli (symbols) that are the same as the target stimulus, opposite of the target stimulus, or neutral with respect to the target stimulus. The task is intended to assess the ability to maintain selective attention in the presence of distractors."|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts||||milliseconds||Standard Deviation|Mean
2747089|NCT00900159|Secondary|Subjective Sleepiness and Performance|The Karolinska Sleepiness Scale (KSS), a nine point Visual Analog Scale of alertness/sleepiness, was used to assess subjective sleepiness. The KSS is a scale from 1 to 9, from minimum to maximum sleepiness.|On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts||||units on a scale||Standard Error|Mean
2747090|NCT00900159|Secondary|EEG-recorded Sleep Efficiency|Polysomnographic recordings of daytime sleep were made at sleep screen (8.5hr) and during daytime sleep episodes of 8.5 hours of duration during treatment visits. Sleep efficiency is calculated based on the time the participant spent in bed and the actual time the participant slept.|On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts||||percentage of time sleeping||Standard Deviation|Mean
2747091|NCT00900159|Primary|Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests|Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts||||minutes||95% Confidence Interval|Mean
2747092|NCT00900146|Primary|Change From Baseline in Dynamic Phase Secreted Insulin Per Unit of Glucose Concentration (Φd) Over 4 Months (Period III)|This was planned as interim analysis and was not conducted because the study was terminated in period III.|Baseline, Over Month 4|The benefit of canakinumab for the treatment of patients with type 2 diabetes mellitus in combination with metformin was inadequate to continue patients into Period IV in the present study, and therefore decided to terminate the study during Period III.|||pmol/min/m2/mmol* hour/L||Standard Error|Least Squares Mean
2747093|NCT00900146|Secondary|Percentage Change From Baseline in Fasting Lipids Profile at Month 4 (Period II)|The fasting lipid profiles included triglycerides, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), calculated very low-density lipoprotein (VLDL), non-HDL cholesterol. Percentage change was measured as [(value at month 4 - baseline value)/baseline value]*100%. The analysis of covariance model included treatment and metformin dose group as main effects and baseline triglycerides, total cholesterol, LDL, HDL, VLDL and non-HDL as covariates.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who randomized in error, did not receive study drug. LOCF method was used for patients without Month 4 data for any reason and who used rescue drug or any other glucose lowering agents other than metformin. 'n' = patients with baseline and endpoints data.|||percent change||Standard Error|Least Squares Mean
2747094|NCT00900146|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at Month 4 (Period II)|The change from baseline in hsCRP (on the logarithmic scale) at Month 4 was measured for this analysis. The analysis of covariance included treatment and metformin dose group as main effects and baseline hsCRP as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||log (mg/L)||Standard Error|Least Squares Mean
2747095|NCT00900146|Secondary|Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Month 4 (Period II)|The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects, the mean score ± SE is 0.366 ± 0.029. The analysis of covariance included treatment and metformin dose group as main effects and baseline QUICKI as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||units on a scale||Standard Error|Least Squares Mean
2747096|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment Insulin Resistance (HOMA2 IR) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S)as a percentage of a normal reference population (normal young adults). The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA2 IR as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||percentage of insulin resistance||Standard Error|Least Squares Mean
2747104|NCT00900146|Secondary|Change From Baseline in Peak Insulin Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour insulin level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/L||Standard Error|Least Squares Mean
2747097|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment B (HOMA2 B) Beta Cell Function (%B) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). Time profile of postprandial glucose, insulin and C-peptide were assessed as measures of β-cell response to stimulation. The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA-B as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||percentage of beta cell function||Standard Error|Least Squares Mean
2747098|NCT00900146|Secondary|Change From Baseline in Fasting Insulin at Month 4 (Period II)|Change in fasting insulin Level measured from blood samples taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting insulin level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/L||Standard Error|Least Squares Mean
2747099|NCT00900146|Secondary|Change From Baseline in Fasting Plasma Glucose at Month 4 (Period II)|Change in Fasting Glucose Level measured from plasma taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
2747100|NCT00900146|Secondary|Change From Baseline in Average Plasma Glucose Level (7-point Glucose Testing) at Month 4 (Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: Month 0 (Baseline), Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. Patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline average plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
2747101|NCT00900146|Secondary|Change From Baseline in Peak Plasma Glucose Level (7-point Glucose Testing) at Month 4(Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: baseline, Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. The patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
2747102|NCT00900146|Secondary|Change From Baseline in 2 Hour Insulin Secretion Rate Derived Based on Glucose and C-peptide Following at Month 4 Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. A 2 hour insulin secretion rate using deconvolution was performed. The deconvolution was an algorithm that analyzed the insulin secretion rate relative to glucose and C-peptide combined. Blood samples were taken prior to and after meal at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2 hour Insulin secretion rate as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/min/m²||Standard Error|Least Squares Mean
2747103|NCT00900146|Secondary|Change From Baseline in Insulin Secretion Rates Relative to Glucose AUC (0-2 Hours) at Month 4 Following Meal Test (Period II)|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. A standard liquid mixed-meal challenge was done at baseline and Month 4. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The model of analysis of covariance included baseline Insulin secretion rate relative to glucose AUC at 0-2 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/min/m²/mmol *hour/L||Standard Error|Least Squares Mean
2747144|NCT00899574|Secondary|Clinical Benefits|This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.|||patients|||Number
2747189|NCT00898677|Secondary|Nausea at 2 Hours After Dose|Patients who recorded the presence or absence of nausea 2 hours after dose|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||participants|||Number
2747105|NCT00900146|Secondary|Change From Baseline in Peak C-peptide Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on the day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak C-peptide level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||nmol/L||Standard Error|Least Squares Mean
2747106|NCT00900146|Secondary|Change From Baseline in Peak Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
2747107|NCT00900146|Secondary|Change From Baseline in 2-hour Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
2747108|NCT00900146|Secondary|Change From Baseline in Insulin Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. Model of analysis of covariance included baseline insulin AUC 0-4 hours as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol*hour/L||Standard Error|Least Squares Mean
2747109|NCT00900146|Secondary|Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Glucose levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The model of analysis of covariance included baseline plasma glucose AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol*hour/L||Standard Error|Least Squares Mean
2747110|NCT00900146|Secondary|Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to start of meal. C-peptide levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The analysis of covariance included baseline C-peptide AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||nmol*hour/L||Standard Error|Least Squares Mean
2747111|NCT00900146|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II)|HbA1c was measured by National glycohemoglobin standardization program (NGSP) certified methodology. HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. The analysis of covariance (ANCOVA) included treatment and metformin dose group as main effects and baseline HbA1c as a covariate.|Baseline, Month 4|The full analysis set (included all randomized patients except for mis-randomized patients who randomized in error but did not receive study drug. Last observation carried forward (LOCF) method was used for patients without Month 4 HbA1c data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||percentage of hemoglobin A1c||Standard Error|Least Squares Mean
2747765|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study Hemoglobin|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||g/L||Full Range|Mean
2747112|NCT00900146|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|4 months (Period II)|The safety set (SAF) included all patients who received at least one dose of study medication during Period II.|||Participants|||Number
2747113|NCT00900029|Primary|Number of Subjects With Target Wound Closed for the First Time During the Study Period.|"At each visit the status of open target ulcers was evaluated as remained open or closed."|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.|||participants|||Number
2747114|NCT00900029|Primary|The Number of Participants With Closed Target Ulcers at Each Visit|At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.|||participants|||Number
2747115|NCT00899847|Secondary|Overall Survival (OS)|To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)|2 years after the last participant is enrolled|Includes all study participants|||percentage of participants||95% Confidence Interval|Number
2747116|NCT00899847|Secondary|Event-free Survival (EFS)|To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)|2 years after the last participant is enrolled|Includes all study participants|||percentage of participants||95% Confidence Interval|Number
2747117|NCT00899847|Secondary|Partial Response Rate (PRR)|"Partial response rate (PRR) was assessed as~> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr~If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain~If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma."|1 year|Includes all study participants|||Participants|||Count of Participants
2747118|NCT00899847|Secondary|Complete Response Rate (CRR)|"Complete response rate (CRR) was assessed as all of:~Negative immunoflixation on the serum and urine~Disappearance of any soft tissue plasmacytomas~< 5% plasma cells in bone marrow"|1 year|Includes all study participants|||Participants|||Count of Participants
2747119|NCT00899847|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)|1 year|Includes all study participants|||Participants|||Count of Participants
2747120|NCT00899847|Secondary|Median Time to Engraftment After Allo-PBSC Transplant|"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia"|1 month|Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC.|||Days||Full Range|Median
2747121|NCT00899847|Secondary|Median Time to Engraftment After Auto-PBSC Transplant|"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia"|1 month|Includes all study participants|||Days||Full Range|Median
2747122|NCT00899847|Primary|Incidence of Graft Versus Host Disease (GvHD)|To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting|2 years after the last participant is enrolled.|Due to the significance of the allo-PBSC transplant as a component to the treatment plan, participants who did not receive allo-PBSC are not included.|||Participants|||Count of Participants
2747123|NCT00899717|Secondary|Condylar Path Angles|Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.|Baseline||||degrees||Standard Deviation|Mean
2747124|NCT00899717|Secondary|Maximum Mouth Opening (mm)|Maximum voluntary unassisted mouth opening|6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up||||mm||Standard Deviation|Mean
2747125|NCT00899717|Secondary|Preferred Chewing Side|The change in the habitual chewing side of each participant across the study|Before and 6 months after therapy||||participants|||Number
2747126|NCT00899717|Secondary|Symptom Checklist-90-Revised (SCL-90-R®)|Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.|Before and 6 months after therapy|Only tests from 15 participants were suitable because of slow or too many positive responses.|||units on a scale||Standard Deviation|Mean
2747127|NCT00899717|Primary|Visual Analogic Scale for Pain Intensity (0-10)|"The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0=No pain and 10=Worst imaginable pain"|Baseline, immediately after therapy, 3 months and 6 months after therapy||||units on a scale||Standard Deviation|Mean
2747128|NCT00899678|Secondary|Percentage of Subjects in Corticosteroid-free Remission at the End of the Study|Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available.|Last/Withdrawal Visit (up to Week 62)|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.|||percentage of paticipants||95% Confidence Interval|Number
2747129|NCT00899678|Secondary|Percentage of Subjects Who Initiated Steroid Tapering|Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose.|From Week 2 up to Week 8|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.|||percentage of subjects||95% Confidence Interval|Number
2749668|NCT00879190|Primary|Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum|Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum|Up to 24 hours after delivery||||Participants|||Count of Participants
2747130|NCT00899678|Secondary|Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)|The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.|From Week 0 to Week 62|Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.|||participants|||Number
2747131|NCT00899678|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)|"The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).~Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).|||ratio||95% Confidence Interval|Geometric Mean
2747132|NCT00899678|Secondary|Erythrocyte Sedimentation Rate (ESR) at Week 62|The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).|||mm/h||95% Confidence Interval|Geometric Mean
2747133|NCT00899678|Secondary|Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)|"The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD).~Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.|||ratio||95% Confidence Interval|Geometric Mean
2747134|NCT00899678|Secondary|C-Reactive Protein (CRP) Levels at Week 62|The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.|||mg/L||95% Confidence Interval|Geometric Mean
2747135|NCT00899678|Secondary|Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)|"Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.~The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|From Week 0 to Week 62|Full Analysis Set (FAS) population|||percentage of participants||95% Confidence Interval|Number
2747136|NCT00899678|Secondary|Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)|"The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.~A negative value in change from Baseline indicates an improvement from Baseline to Week 62."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.|||units on a scale||Standard Deviation|Mean
2747137|NCT00899678|Secondary|Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62|The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.|||Score on a scale||Standard Deviation|Mean
2747138|NCT00899678|Primary|Percentage of Subjects in Clinical Remission at Week 62|"Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10.~The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|Week 62|Full Analysis Set (FAS) population|||percentage of participants||95% Confidence Interval|Number
2747139|NCT00899600|Secondary|Percentage of Participants With Complications/Adverse Events|Adverse events|48 hours and 6 weeks||||Percent|||Number
2747140|NCT00899600|Secondary|Hemodynamic Changes - Blood Pressure|Hemodynamic change (Blood Pressure) from baseline in the intraoperative and 48-h postoperative periods|Baseline, Inoperative (approximately) 48 hours|Analysis included only a subgroup of participants who had not used non-steroidals (NSAIDS).|||mmHg||Standard Deviation|Mean
2747141|NCT00899600|Secondary|Hemodynamic Changes - Heart Rate|Hemodynamic change (Heart Rate) from baseline in the intraoperative and 48-h postoperative periods|Baseline, Inoperative (approximately) 48 hours|Analysis included only a subgroup of participants who had not used non-steroidals (NSAIDS).|||beats per minute||Standard Deviation|Mean
2747142|NCT00899600|Secondary|Hospital Duration||Discharge from hospital, approximately 2 days after surgery||||minutes||Standard Deviation|Mean
2747143|NCT00899600|Primary|Morphine Consumption in the First 48 Hours After Surgery|Total morphine(mg)consumed at 48 hours.|48 hours|See methodology|||mg||Standard Deviation|Mean
2747145|NCT00899574|Primary|Objective Response (Complete Clinical Response+ Partial Response)|This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.|||percentage of patients||95% Confidence Interval|Number
2747146|NCT00899548|Post-Hoc|Overall Survival in Participants With High CTC vs. Low CTC|"overall survival in participants with high or low cumulative tumor cells (CTC). high CTC refers to >5 cells/7.5mL and low CTC refers to <5 cells/7.5mL."|4 weeks|Data for this outcome measure was collected from only 96 participants.|||months||95% Confidence Interval|Median
2747147|NCT00899548|Other Pre-specified|Determination if the Addition of CTCs to Serum Methylation Results in an Improved Predictive Model||3-4 weeks|||||||
2747148|NCT00899548|Secondary|Correlation of CTCs With Serum Methylation||3-4 weeks|Data was not collected for this outcome measure||||||
2747149|NCT00899548|Secondary|Overall Survival in Patients With a High vs. Low CMI Value||from week 4 to up to 3 years|141/179 participants who completed the study were evaluable for this outcome measure. Of these, 7 participants were excluded from analysis for events experienced before week 4, 2 participants had inadequate samples for analysis and data was not collected from 3 participants.|||months||95% Confidence Interval|Median
2747150|NCT00899548|Primary|Creation of a Predictive Model of DNA Methylation Profiles||9-12 weeks|Data was not collected to assess this outcome measure||||||
2747151|NCT00899548|Primary|Effects of Common Exposures (i.e., Alcohol, Smoking, Medications, and Dietary Factors) on Patterns of Serum Methylation||9-12 weeks|Data was not collected to assess this outcome measure||||||
2747152|NCT00899548|Primary|Changes in Methylated Gene Markers as Measured by Cumulative Methylation Index|log change in cumulative methylation index (CMI) from baseline to week 4. Individual gene methylation (M) is calculated as a methylation index (MI) where MI = (methylated copies)/(number of methylated genes + gene standard copies) * 100. The MI of each sample was averaged across duplicates. The cumulative methylation index (CMI) is the sum of the MI for all genes. The log change from based line to week 4 could increase or decrease. CMI was evaluated as a continuous marker for change from baseline.|baseline, week 4|Data to assess this outcome measure was only collected from 129/182 participants with metastatic breast cancer.|||log CMI change||Standard Deviation|Mean
2747153|NCT00899548|Primary|Progression-free Survival in Patients With a High vs. Low Cumulative Methylation Index (CMI) Value||from week 4 to up to 87 months|141/179 participants who completed the study were evaluable for this outcome measure. Of these, 8 participants were excluded from analysis for events experienced before week 4, 2 participants had inadequate samples for analysis and data was not collected from 3 participants.|||months||95% Confidence Interval|Median
2747154|NCT00899470|Secondary|Number of Participant With Clinically Relevant Physical Examination Abnormalities|A physical examination was conducted which included height and weight measurements, from which the Body Mass Index was determined. Physical examination abnormalities were judged to be of medical importance by the Investigator.|Screen, Period 1 Day -1, prior to discharge|All Treated Participants|||participants|||Number
2747155|NCT00899470|Secondary|Number of Participants With Clinically Relevant Vital Sign Abnormalities|Mean systolic and diastolic blood pressure, heart rate, respiration, and temperature were assessed.Vital sign abnormalities abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants|||participants|||Number
2747156|NCT00899470|Secondary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities|PR interval, QRS complex, width of QRS, QT interval, and QT corrected for heart rate adjusting for heart rate using either Bazett formula or Fridericia formula were measured. ECG abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants|||participants|||Number
2747157|NCT00899470|Secondary|Number of Participants With Laboratory Marked Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Leukocytes: <0.9 x LLN/ >1.2 x ULN; blood urea nitrogen (BUN): >1.1 x ULN; creatinine: >1.33 x BL; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN; creatinine kinase (CK): >1.5 x ULN; urine blood=use ≥2 x BL if value ≥2+ or BL1+|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants|||participants|||Number
2747158|NCT00899470|Secondary|Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants|||participants|||Number
2747159|NCT00899470|Secondary|BMS-510849 Mean T-half and T-max|T-half and Tmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administerd as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||hours||Standard Deviation|Mean
2747160|NCT00899470|Secondary|BMS-510849 Mean AUC (0-INF)|AUC (0-T)= for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
2747165|NCT00899470|Primary|Metformin Mean AUC (0-T)|AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
2747166|NCT00899470|Primary|Metformin Mean Cmax|Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng/mL||Standard Deviation|Mean
2747167|NCT00899470|Primary|Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)|T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||hours||Standard Deviation|Mean
2747168|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
2747169|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
2747170|NCT00899470|Primary|Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)|Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng/mL||Standard Deviation|Mean
2747171|NCT00899431|Secondary|Percentage of Participants With GVHD (Graft Versus Host Disease)|Acute grade 2 to 4 Graft versus host disease( GVHD )for patients who were able to be analyzed by measuring the T cell counts for increased CD3+ before and after lenalidomide.|Up to 6 months after allotransplant||||Participants|||Count of Participants
2747172|NCT00899431|Primary|Immunomanipulation After Non-myeloablative Stem Cell Transplantation for CLL (Chronic Lymphocytic Leukemia).|"To compare the need for immunomanipulation within 18 months after non-myeloablative allogeneic transplantation for CLL between the two combination therapies with or without lenalidomide maintenance. For this purpose, immunomanipulation is defined as any one of the following events: 1) Cessation of administering tacrolimus treatment with in the first 6 months after allotransplant due to persistent disease or progression. 2) Boost of donor lymphocytic infusion (DLI) administered anytime between 3 and 18 months after allotransplant."|Up to 18 months after allotransplant.|Data were not collected due to low accrual of participants and protocol was terminated.||||||
2747173|NCT00899392|Secondary|GI Suite Flow Efficiency Measured in 15 Minute Increments||At completion of study|||||||
2747174|NCT00899392|Secondary|Questions Asked by Subjects (Parents)|Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.|Questions written by parents during the end of consent process (48-72 hours)||||Questions||Full Range|Mean
2747175|NCT00899392|Secondary|Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)|s-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.|12-18 hours (Night before Endoscopy to Day of Endoscopy)|Matched pairs (pre consent and post consent), Pilot data included to increase power analysis|||Units on a Scale (STAI Score)||Standard Deviation|Mean
2747176|NCT00899392|Secondary|Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)|Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.|Every 1-2 months|(Consent Group + some pilot participants to increase power of analysis)|||Units on a scale||Standard Deviation|Mean
2747177|NCT00899392|Primary|Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)|"Units on a scale (score) as Measured by Consent 20 Instrument.~20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.~Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40"|Every 1-2 months||||Units on a scale||Standard Deviation|Mean
2747178|NCT00899379|Secondary|Pain Relief at 2 Hours During the Fourth Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.|||Participants|||Number
2747236|NCT00897390|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
2747179|NCT00899379|Secondary|Pain Relief at 2 Hours During the Third Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.|||Participants|||Number
2747180|NCT00899379|Secondary|Pain Relief at 2 Hours During the Second Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.|||Participants|||Number
2747181|NCT00899379|Primary|Pain Relief at 2 Hours During the First Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack|2 hours|The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase.|||participants|||Number
2747182|NCT00899353|Primary|The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.|"Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.~Patients with MGUS or SMM were not enrolled into this study."|Baseline, month 1, month 2, month 3, month 6, month 9, 12 months|Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.|||Fold Change|||Number
2747183|NCT00899353|Primary|Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.|Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.|baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)|NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (> median, n=7) and low initial baseline (< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods|||10^6 NFkB Luminescence units/µg protein||Standard Error|Mean
2747184|NCT00898937|Primary|Tumor Gene Expression as Assessed by RNA Microarray Analysis|Concentration of RNA recovered from breast needle biopsies|1 day||||micrograms||Standard Error|Mean
2747185|NCT00898807|Secondary|Neuropsychiatric Inventory (NPI)-- Agitation Subscore|NPI agitation score is based on responses from an informed caregiver involved in the patient's life. Symptom severity (1=mild, 2=moderate, 3=severe) is multiplied by frequency (1=occasionally, less than once/week; 4 = very frequently, once or more/day or continuously) to obtain the NPI agitation score.Range is 0-12. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."|||units on a scale||Standard Deviation|Mean
2747186|NCT00898807|Secondary|Cohen-Mansfield Agitation Inventory (CMAI)|CMAI examines several agitated behaviors including verbal, physical agitation, and other behaviors. Sub-items are summed. Range is 14-70. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."|||units on a scale||Standard Deviation|Mean
2747187|NCT00898807|Primary|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)|"Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in agitation(CGIC) accesses clinically significant change in agitation. A trained clinician, blind to treatment assignment, uses a 7-point Likert scale to rate change of each patient along a continuum from marked improvement(1), no change(4), and marked worsening(7). A number of aspects of the agitation is considered such as emotional agitation, mood liability/distress, psychomotor agitation, verbal aggression, and physical aggression. Range is 1-7."|Baseline to 9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on CGIC."|||percentage moderate/marked improvement|||Number
2747188|NCT00898807|Primary|NeuroBehavior Rating Scale-- Agitation|NeuroBehavioral Rating Scale- Agitation(NBRS-A) assesses multiple types of psychopathology common in dementia and is based on a seven point Likert scale of increasing severity for each item(i.e., 0=not present, 1=very mild, 2-mild, 3=moderate, 4=moderately severe, 5=severe, 6=extremely severe). The NBRS agitation subscore includes NBRS 'inhibition', 'agitation', and 'hostility'. The range is 0 to 18 points. Higher scores indicate more symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on the NBRS."|||units on a scale||Standard Error|Mean
2747190|NCT00898677|Secondary|Functional Status at 2 Hours After Dose|Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747191|NCT00898677|Secondary|Pain Free at 2 Hours After Dose|Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.|||Participants|||Number
2747192|NCT00898677|Primary|Time to Relief Within 2 Hours After Dose|Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose|within 2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.|||Participants|||Number
2747193|NCT00898677|Primary|Pain Relief at 2 Hours After Dose|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.|||Participants|||Number
2747194|NCT00898560|Secondary|AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day||||ng.h/mL||Standard Deviation|Mean
2747195|NCT00898560|Secondary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day||||ng.h/mL||Standard Deviation|Mean
2747196|NCT00898560|Primary|Cmax - Maximum Observed Plasma Concentration|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day||||pg/mL||Standard Deviation|Mean
2747197|NCT00898443|Secondary|Impact of Anesthesia Type on OR (Operating Room) Efficiency|The time minutes)from initiation of anesthesia to surgery start.|minutes until surgery start|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.|||minutes||Full Range|Median
2747198|NCT00898443|Primary|Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation|Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)|at the time of surgery|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.|||participants|||Number
2747199|NCT00898222|Primary|Change in Exhaled Inflammatory Mediator Levels|Descriptive statistics|baseline and 6 months||||pg/mL||Full Range|Mean
2747200|NCT00897949|Secondary|Pain Relief 2 Hours After Treatment for Headache Recurrence|Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).|2 hours after treatment for recurrence|Patients with initial headache recurrence who took rizatriptan 5 mg or 10 mg were prerandomized (ratio=1:1) to either rizatriptan 5 mg or 10 mg, respectively, or to placebo (ratio=1:1); and who took placebo, to either 5 mg or 10 mg of rizatriptan (ratio=1:1). Only those who took rizatriptan for their initial headache were considered for analysis.|||Participants|||Number
2747201|NCT00897949|Secondary|Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug||2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747202|NCT00897949|Secondary|No Disability at 2 Hours After the Initial Dose of Test Drug|Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of functional disability within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747203|NCT00897949|Secondary|Pain Free at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747204|NCT00897949|Primary|Pain Relief at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|The primary analysis employed an “all-patients-treated” approach that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747205|NCT00897910|Secondary|Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.|||||||
2747206|NCT00897910|Primary|Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.|||||||
2747207|NCT00897897|Secondary|Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.|"Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.~The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms."|At baseline and at 30 days following treatment||||scores on a scale||Standard Deviation|Mean
2747208|NCT00897897|Primary|Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.|30 days after treatment||||Adverse Event/subject||Standard Deviation|Mean
2747209|NCT00897715|Secondary|Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks|IL-6 is a sensitive laboratory assay for serum levels of Interleukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville|||pg/ml||Inter-Quartile Range|Median
2747210|NCT00897715|Primary|Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks|hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville.|||mg/dl||Inter-Quartile Range|Median
2747211|NCT00897676|Secondary|Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1)|Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 min to time 360 min||||pmol*min/L||Standard Deviation|Mean
2747212|NCT00897676|Secondary|Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1)|Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 to time 360 min||||pmol*min/L||Standard Deviation|Mean
2747213|NCT00897676|Secondary|Area Under the Curve (AUC) Plasma Glucagon|Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 min to time 360 min||||pg*min/mL||Standard Deviation|Mean
2747214|NCT00897676|Secondary|Area Under the Curve (AUC) Plasma C-peptide|Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 min to time 360 min||||ng*min/mL||Standard Deviation|Mean
2747215|NCT00897676|Secondary|Area Under the Curve (AUC) Plasma Insulin|Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion|time 0 min to time 360 min|data from only 15 subjects because the values were below the level of detection for one subject.|||uIU*min/mL||Standard Deviation|Mean
2747216|NCT00897676|Primary|Area Under the Curve (AUC) Plasma Glucose|Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion|Time 0 min - time 360 min|A total of 16 subjects were included in the analysis. 1 subject was withdrawn.|||mg*min/dL||Standard Deviation|Mean
2747217|NCT00897390|Secondary|Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities|12-lead Electrocardiogram (ECG), Vital Sign (body temperature, respiratory rate, seated blood pressure and heart rate), and Physical Finding Abnormalities reported by investigator as AEs.|At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.|||participants|||Number
2747218|NCT00897390|Secondary|Number of Participants With Marked Urinalysis Abnormalities|Protein, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Glucose, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Blood, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). White Blood Cell (WBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). Red Blood Cell (RBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). (The '+' is a normal lab result and refers to the magnitude of the finding.)|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Number of Participants Analyzed=treated participants; n=number of participants evaluated for this measure (among the 6 participants who had the urinary WBC and RBC test, there are only 2 had a pre-study evaluation, and were therefore evaluable for these measures.|||participants|||Number
2747237|NCT00897104|Secondary|Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])|Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence|24 hours|The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence.|||Hours||Standard Deviation|Mean
2747219|NCT00897390|Secondary|Number of Participants With Marked Laboratory Abnormalities (MA)|Laboratory abnormalities=any result that is clinically significant, met the definition of an SAE, required discontinuation or interruption of study drug, or required specific corrective therapy. Upper normal (UN)/lower normal (LN) values: leukocytes UN, 11.40x10^3 c/uL; absolute neutrophils/bands LN, 1.500x10^3 c/uL; aspartate aminotransferase UN, 48 U/L; alanine aminotransferase UN, 67 U/L; blood urea nitrogen UN, 20.0 mg/dL; creatine kinase UN, 350 U/L; lactate dehydrogenase UN, 249 U/L.|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.|||participants|||Number
2747220|NCT00897390|Secondary|AEs of Special Interest|See Outcome Measure 16 for a definition of AEs. AEs of clinical interest for saxagliptin were defined as those relating to the following:skin disorders, infection-related AEs (system organ class [SOC]: Infections and Infestations), thrombocytopenia, lymphopenia, hypoglycemia, cardiovascular AEs indicative of acute cardiovascular events, localized edema, fractures, pancreatitis, and AEs of hypersensitivity.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).|All treated participants|||participants|||Number
2747221|NCT00897390|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject's participation in the study.|All treated participants|||participants|||Number
2747222|NCT00897390|Secondary|BMS-510849 PK Parameter T-Max|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Full Range|Median
2747223|NCT00897390|Secondary|BMS-510849 PK Parameter T-Half|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from their respective plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Standard Deviation|Mean
2747224|NCT00897390|Secondary|BMS-510849 PK Parameter Cmax|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng/mL||Full Range|Geometric Mean
2747225|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(0-T)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
2747226|NCT00897390|Primary|Metformin PK Parameter Tmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Full Range|Median
2747227|NCT00897390|Primary|Metformin PK Parameter T-HALF|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Standard Deviation|Mean
2747228|NCT00897390|Primary|Metformin PK Parameter Cmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng/mL||Full Range|Geometric Mean
2747229|NCT00897390|Primary|Metformin PK Parameter AUC(0-T)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
2747230|NCT00897390|Primary|Metformin PK Parameter AUC(INF)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
2747231|NCT00897390|Primary|Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Full Range|Median
2747232|NCT00897390|Primary|Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Standard Deviation|Mean
2747233|NCT00897390|Primary|Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng/mL||Full Range|Geometric Mean
2747234|NCT00897390|Primary|Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
2747235|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(INF)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
2747238|NCT00897104|Secondary|Participants Who Used Escape Medication 2 Hours After the Treatment Dose|Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747239|NCT00897104|Secondary|Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment|Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.|2 hours after treatment|“All-participants-treated” approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories.|||Participants|||Number
2747240|NCT00897104|Secondary|Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities|Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747241|NCT00897104|Secondary|Pain Free at 2 Hours After Treatment|Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747242|NCT00897104|Primary|Time to Relief Within 2 Hours After Treatment|Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).|within 2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication.|||Participants|||Number
2747243|NCT00897104|Primary|Pain Relief at 2 Hours After Treatment|Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
2747244|NCT00896779|Primary|Mean Change in Visual Acuity|Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported.|12 months||||letters||Standard Deviation|Mean
2747245|NCT00896649|Secondary|Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study|Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied.|One month|All participants who completed imaging and questionnaires.|||participants|||Number
2747246|NCT00896649|Primary|"Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 in Positron Emission Mammography"|"Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 in positron emission mammography~Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale:~0 = Inconclusive for malignancy; call-back in mammography~= normal~= abnormal, with no malignancy~= abnormal, likely benign~= abnormal, likely malignant~= malignant"|immediately at completion of mammogram|Number of participants who completed protocol with complete data set|||participants|||Number
2747247|NCT00896532|Secondary|Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)|Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.|Baseline and months 1, 3, 6, 9, and 12|All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.|||percent change||95% Confidence Interval|Least Squares Mean
2747248|NCT00896532|Secondary|Percent Change From Baseline in Osteocalcin|Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.|Baseline and months 1, 3, 6, 9, and 12|All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.|||percent change||95% Confidence Interval|Least Squares Mean
2747300|NCT00896441|Secondary|Hamilton Anxiety Scale|Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.|% change in anxiety from Day 1 to Day 56 (week 8)|Only participants completing the protocol are included in the analysis. Only participants in the Depressed group were analyzed for change in anxiety symptoms.|||percentage of change in anxiety||Standard Deviation|Mean
2747249|NCT00896532|Secondary|Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)|Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.|Baseline and months 1, 3, 6, 9, and 12|All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.|||percent change||95% Confidence Interval|Least Squares Mean
2747250|NCT00896532|Secondary|Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)|Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.|Baseline and months 1, 3, 6, 9, and 12|All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.|||percent change||95% Confidence Interval|Least Squares Mean
2747251|NCT00896532|Secondary|Percent Change From Baseline at Month 12 in BMD of the Distal Radius|"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables."|Baseline to 12 months|All randomized participants who had non-missing baseline and month 12 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747252|NCT00896532|Secondary|Percent Change From Baseline at Month 12 in BMD of the Femoral Neck|"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables."|Baseline to 12 months|All randomized participants who had non-missing baseline and month 12 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747253|NCT00896532|Secondary|Percent Change From Baseline at Month 12 in BMD of the Total Hip|"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables."|Baseline to 12 months|All randomized participants who had non-missing baseline and month 12 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747254|NCT00896532|Secondary|Percent Change From Baseline at Month 6 in BMD of the Femoral Neck|"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables."|Baseline to 6 months|All randomized participants who had non-missing baseline and month 6 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747255|NCT00896532|Secondary|Percent Change From Baseline at Month 6 in BMD of the Total Hip|"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables."|Baseline to 6 months|All randomized participants who had non-missing baseline and month 6 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747256|NCT00896532|Secondary|Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine|"Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.~Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables."|Baseline to 6 months|All randomized participants who had non-missing baseline and month 6 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747257|NCT00896532|Primary|Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine|Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.|Baseline to 12 months|All randomized participants who had non-missing baseline and month 12 measurements.|||percent change||95% Confidence Interval|Least Squares Mean
2747266|NCT00896480|Primary|Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hNA - SCR G0; SE G3 = hNA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747258|NCT00896480|Primary|Number of Patients With Any Serious Adverse Events (SAEs) Related to Treatment Administration|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. SAEs reported are here below tabulated irrespective of grade (any), related to study treatment, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE.|Within the 31-day (Day 0-30) follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747259|NCT00896480|Primary|Number of Patients With Any Serious Adverse Events (SAEs)|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE.|Within the 31-day (Day 0-30) follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747260|NCT00896480|Primary|Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE.|Within the 31-day (Day 0-30) follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747261|NCT00896480|Primary|Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE.|Within the 31-day (Day 0-30) follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747262|NCT00896480|Primary|Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. PLT - SCR G0; SE G3 = PLT with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747263|NCT00896480|Primary|Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. NEU - SCR G0; SE G3 = NEU with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747264|NCT00896480|Primary|Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LYM - SCR G0; SE G3 = LYM with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747265|NCT00896480|Primary|Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LEU - SCR G0; SE G3 = LEU with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2749882|NCT00877929|Secondary|Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 8|Treated set using last observation carried forward (LOCF)|||participants|||Number
2747267|NCT00896480|Primary|Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hKA - SCR G0; SE G3 = hKA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747268|NCT00896480|Primary|Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hCA - SCR G0; SE G3 = hCA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747269|NCT00896480|Primary|Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hAL - SCR G0; SE G3 = hAL with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747270|NCT00896480|Primary|Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HNA - SCR G0; SE G3 = HNA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747271|NCT00896480|Primary|Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HKA - SCR G0; SE G3 = HKA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747272|NCT00896480|Primary|Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HCA - SCR G0; SE G3 = HCA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747273|NCT00896480|Primary|Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HGB - SCR G0; SE G3 = HGB with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747274|NCT00896480|Primary|Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. GGT - SCR G0; SE G3 = GGT with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747752|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (t1/2)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
2747275|NCT00896480|Primary|Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. CREA - SCR G0; SE G3 = CREA with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747276|NCT00896480|Primary|Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. BIL - SCR G0; SE G3 = BIL with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747277|NCT00896480|Primary|Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALK - SCR G0; SE G3 = ALK with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747278|NCT00896480|Primary|Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. AST - SCR G0; SE G3 = AST with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747279|NCT00896480|Primary|Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade|"The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).~The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALT - SCR G0; SE G3 = ALT with no abnormality/normal value at screening and with Severe abnormality at study end]."|From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4)|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747280|NCT00896480|Primary|Number of Patients Reported With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.|During the entire study period (from Day 0 to CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A ASCI study treatment.|||Participants|||Count of Participants
2747281|NCT00896480|Primary|Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0.|The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e. invasive procedures, modification of patient's previous therapeutic regimen).|Within the 31-day (Days 0-30) post-administration periods|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment.|||Participants|||Count of Participants
2747753|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (Tmax)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
2747282|NCT00896480|Primary|Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization)|A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).|From Week 5 to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.|||Participants|||Count of Participants
2747283|NCT00896480|Primary|Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off|A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).|From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.|||Participants|||Count of Participants
2747284|NCT00896480|Primary|Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization|This endpoint presents the geometric mean concentration, expressed in titers, of anti-MAGE-A3 specific CD4+ and CD8+ T-cells. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).|From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.|||Titers||95% Confidence Interval|Geometric Mean
2747285|NCT00896480|Primary|Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies|For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|From Day 2 to Concluding visit (CCL:at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.|||Participants|||Count of Participants
2747286|NCT00896480|Primary|Number of Seroconverted Patients for Anti-MAGE-A3|Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 EL.U/mL.|From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.|||Participants|||Count of Participants
2747287|NCT00896480|Primary|Anti-MAGE-A3 Antibody Concentrations|Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per millilitre (EL.U/mL). A seropositive patient was defined as a patient whose anti-MAGE-A3 antibody concentration was greater than or equal to 27 EL.U/mL. D=Day W=Week|From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion|The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2747288|NCT00896480|Primary|Time to Treatment Failure (TTF), by Gene Signature|TTF was defined as withdrawal from treatment with the GSK2132231A study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.|From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or death|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment|||Months||95% Confidence Interval|Median
2747289|NCT00896480|Primary|Number of Patients With Mixed Response (MR) to GSK2132231A|Assessment was done based on a set of MLs identified at baseline as TLs and non-TLs (NTL) followed up until disease progression. MLs were assessed as regards matching below MR definitions. In case of evaluability per RECIST: a) MR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). In case of non-evaluability per RECIST (due to LD<20mm): a) MR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion).|From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment|||Participants|||Count of Participants
2747290|NCT00896480|Primary|Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment|OR was defined as the best Overall Response (OR) in a patient. OR = Complete Response (CR) + Partial Response (PR). Responses were categorized as CR, PR, stable disease (SD), SD/PR, progressive disease (PD) and non-evaluable (NE). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) = neither sufficient shrinkage to be PR, not sufficient increase to qualify for Progressive Disease (PD); PD = ≥20% increase in the sum of largest diameter for target lesions. Best objective response = PR or CR. Disease control = CR, or PR, or SD, or SD/PR.|From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions|The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment|||Participants|||Count of Participants
2747291|NCT00896454|Secondary|Change From Baseline in Corrected Serum Calcium||Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.|||mmol/L||Inter-Quartile Range|Median
2747292|NCT00896454|Secondary|Time to Relapse/Nonresponse of Hypercalcemia of Malignancy|Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset|||days||95% Confidence Interval|Median
2747293|NCT00896454|Secondary|Duration of Complete Response|Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a complete response in the Response Analysis Subset|||days||95% Confidence Interval|Median
2747294|NCT00896454|Secondary|Duration of Response|Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a response in the Response Analysis Subset|||days||95% Confidence Interval|Median
2747295|NCT00896454|Secondary|Time to Complete Response|Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan-Meier methods.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset|||days||95% Confidence Interval|Median
2747296|NCT00896454|Secondary|Time to Response|"Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1.~Time to response was analyzed using Kaplan-Meier methods."|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset|||days||95% Confidence Interval|Median
2747297|NCT00896454|Secondary|Percentage of Participants With a Complete Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 - serum albumin [g/dL])).|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset|||percentage of participants||95% Confidence Interval|Number
2747298|NCT00896454|Secondary|Percentage of Participants With a Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 - serum albumin [g/dL]))|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset|||percentage of participants||95% Confidence Interval|Number
2747299|NCT00896454|Primary|Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 - serum albumin [g/dL]))|10 days|Response Analysis Subset including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) > 12.5 mg/dL (3.1 mmol/L).|||percentage of participants||95% Confidence Interval|Number
2747313|NCT00896363|Secondary|Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.|PK/PD relationships for GSK163090 in participants with MDD data was not collected.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|PK population.||||||
2747301|NCT00896441|Primary|Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex|The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.|baseline and week 8|Owing to the limited sample size, we first examined this measure in the depressed subjects using a paired-sample t-test at each of the 30,000+ voxels. No significant voxels were detected in this analysis and so subsequent analyses combining the depressed subjects and the healthy control subjects in a single model were not performed.|||significant voxels|||Number
2747302|NCT00896441|Primary|Hamilton Depression Rating Scale Percent Change From Day 0 to D56|Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression|% change from baseline to Day 56 ( week 8)|Only participants completing the protocol are included in the analysis; thus, the N = 12. Only participants in the Depressed group were analyzed for change in depressive symptoms.|||percentage of change in depression||Standard Deviation|Mean
2747303|NCT00896389|Secondary|Change in Plasma Sodium/Potassium Level During High Dose of HCTZ|Na/K ratio is a function of kidney function|Plasma sodium and potassium measured from blood collected pre and post salt loading|25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ratio||Standard Error|Mean
2747304|NCT00896389|Primary|Fasting Glucose Change After 7 Days of High Dose (25mg) of HCTZ|Values on Day 8 subtracts Day 0.|Fasting glucose was measured on day 0 and day 8|25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype 11 is homozygous for the minor allele G, genotype 12 is heterozygous, genotype 22 is homozygous for the major allele A.|||mmHg||Standard Error|Mean
2747305|NCT00896389|Primary|Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ|Values on Day 8 subtracts Day 0.|Fasting glucose was measured on day 0 and day 8|28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
2747306|NCT00896389|Primary|Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ|Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.|24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8|25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
2747307|NCT00896389|Primary|Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ|Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.|24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8|28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
2747308|NCT00896389|Secondary|Change in Plasma Sodium/Potassium Level During Low Dose of HCTZ|Na/K ratio is a function of kidney function|Plasma sodium and potassium measured from blood collected pre and post salt loading|28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype 11 is homozygous for the minor allele G, genotype 12 is heterozygous, genotype 22 is homozygous for the major allele A.|||ratio||Standard Error|Mean
2747309|NCT00896389|Secondary|Change in Plasma Sodium/Potassium Level Due to Salt-loading|Na/K ratio is a function of kidney function|Plasma sodium and potassium measured from blood collected pre and post salt loading|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ratio||Standard Error|Mean
2747310|NCT00896389|Secondary|Change in Plasma Renin Activity Due to Salt-loading|Renin is an enzyme that mediates extracellular fluid and regulates blood pressure. Plasma renin activity (PRA) is a measure of the activity of the plasma enzyme renin. PRA is measured in the laboratory by incubating plasma at physiologic temperature in a buffer that facilitates its enzymatic activity. The natural substrate for the enzyme renin is angiotensinogen. Exogenous angiotensinogen is not added to the reaction mixture. This means that, in effect, the PRA results reported are dependent on both renin concentration and the concentration of its substrate in the patient's plasma. Renin cleaves angiotensinogen to produce a decapeptide, angiotensin I, the concentration of which is assayed using liquid chromatography accompanied by tandem mass spectroscopic detection (LC/MS/MS). PRA levels are reported as the amount of angiotensin I generated per unit of time. Change is defined as the post-salt loading values minus the pre-salt loading values|Renin was measured from blood collected pre and post salt loading|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ng/ml/h||Standard Error|Mean
2747311|NCT00896389|Secondary|Change in Plasma Aldosterone Level Due to Salt-loading|Aldosterone is a hormone that plays a critical role in homeostatic regulation of blood pressure. Change is defined as the post-salt loading values minus the pre-salt loading values|Aldosterone was measured from blood collected pre and post salt loading|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ng/dL||Standard Error|Mean
2747312|NCT00896389|Primary|Blood Pressure Change During Salt Loading|"Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured every 15 minutes for 4 hours.~Blood pressure change is calculated by the trapezoid method. Essentially we use the average of blood pressure at each pair of time points (for example, DBP 30min + DBP 15min)/2 + (DBP 45min + DBP 30min)/2 + … up to 4 hours.) normalized by baseline SBP/DBP."|Every 15 minutes for 4 hours|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, and genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
2749924|NCT00877604|Secondary|Medical Research Council Scores for Right and Left Muscle Groups||1 year|||||||
2747314|NCT00896363|Secondary|Average Concentration (Cave) at Steady State|PK samples were supposed to be collected to estimate individual specific parameters like Cave however data for this outcome was not collected.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|PK population.||||||
2747315|NCT00896363|Secondary|Area Under Concentration-time Curve (AUC) at Steady State|PK samples were supposed to be collected to estimate individual specific parameters like AUC however data for this outcome was not collected.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|PK population.||||||
2747316|NCT00896363|Secondary|Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period|Ctrough is defined as trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]). Concentration was reported at specified time points.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|The ‘PK population' comprised of participants in the intent to treat population for whom a pharmacokinetic sample was obtained and analyzed.|||microgram per liter||Standard Deviation|Mean
2747317|NCT00896363|Primary|Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Day 52|All subjects population. The number of participants available at the particular time point were used for analysis.|||Participants|||Number
2747318|NCT00896363|Primary|Mean of Change From Baseline in Heart Rate|Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute, (beats per minute). Heart rate was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.|Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2747319|NCT00896363|Primary|Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)|Semi-supine systolic and diastolic blood pressure was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. BP was measured at least every hour until the values were within the normal range. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.|Baseline (Day 1) , Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2747320|NCT00896363|Primary|Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval|Data for change from Baseline was reported for PR Interval, QRS Duration, QT Interval, QTcB, QTcF, and RR Interval. 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTcB ,QTcF, and RR intervals. Day -1 evening (PM) was the Baseline for participants with only Day -1 records. Day 1 PM Dose was the Baseline for participants with Day 1 records. Baseline was the mean of replicate assessments. Change from Baseline was the difference between the value at the time point analyzed and baseline value.|Baseline (Day 1) and up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||milisecond (msec)||Standard Deviation|Mean
2747321|NCT00896363|Primary|Number of Participant of Urinanalysis Assessment Over Period|Urinalysis parameters included: Urine Occult Blood, Urine Ketones, Urine Ketones. data for number of participants with abnormal urinanalysis parameters was reported by dipstick method. dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. dipstick test gives results in a semi-quantitative manner, and results can be read as negative, Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Urine occult blood dipstick and urine general dipstick were semi quantitative results. Urine glucose and urine ketones dipstick results were in milimole per liter, urine protein dipstick results were in gram per liter.|Screening (Day -10 to -2), Day 14 and Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2747322|NCT00896363|Primary|Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin|Liver chemistry parameters: Direct Bilirubin and Total Bilirubin were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.|Baseline (screening) up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||UMOL/L||Standard Deviation|Mean
2747323|NCT00896363|Primary|Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT|Clinical liver chemistry parameters of Alkaline Phosphatase , ALT, AST, GGT were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.|Baseline (screening) up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||International unit per litre (IU/L)||Standard Deviation|Mean
2747377|NCT00896337|Secondary|Technical Success|Residual lesion stenosis <=30% based on visual assessment immediately postprocedure|Index procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of lesions|Participants||Number
2747324|NCT00896363|Primary|Number of Participants With Abnormal Chemistry Values of CCR|Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) were: albumin (unit: gram per liter): < 30, NA; alanine aminotransferase (ALT): NA, >= 3 times upper limit of normal; aspartate aminotransferase (AST): NA, >= 3 times upper limit of normal; total bilirubin: NA, >=1.5 times upper limit of normal; calcium: < 2.0, > 2.75; gamma glutamyl transferase (GGT): < 3.0, > 9; potassium: < 3.0, > 5.5; magnesium: < 0.5, > 1.23.|Up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2747325|NCT00896363|Primary|Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).|Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) were: hemoglobin (Hb): > 25, 180; hematocrit (Hct): > 0.075, 0.54; absolute neutrophil count (ANC): < 1.5, NA; platelet: < 100, > 550; white blood cells (WBC): < 3,> 20|Up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2747326|NCT00896363|Primary|Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS was a clinician-rated scale that evaluated severity and change of suicidality by integrating both behaviour and ideation. The 2 of 3 sections of the scale were suicidal behavior and suicidal ideation. For suicidal behaviour participants were scored as non-suicidal-0, preparatory acts or behavior communicating ideation-01, aborted attempt-2, interrupted attempt-3 or actual attempt-4. The score ranges from 0-4, where 0 was absence of suicidal behavior and 4 being the most severe form of suicidal behavior. On the Suicidal Ideation scale, participants were scored as non-suicidal-0, wish to be dead-1, non-specific active suicidal thoughts-2, active suicidal ideation with associated thoughts of methods without intent-3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan-4, active suicidal ideation with plan and intent-5. The score ranges from 0-5, where 0 was absence of suicidal ideation and 5 being the most severe form of suicidal ideation.|Up to Day 52|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2747327|NCT00896363|Primary|Change From Baseline in Quick Inventory of Depressive Symtomatology - Self Rated (QIDS-SR) Scale, on Day 14 and 42|The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle, and late insomnia or hypersomnia), appetite/weight increase/decrease and psychomotor agitation/retardation. A total score was obtained by summing scores on each domain. the scores ranges from 0 (none) to 27 (very severe), where the highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1. Change from Randomization in total score was the difference between QIDS total score at the time point being analyzed to randomization.|Baseline (Day 1, pre-dose), Day 14 and Day 42|Intent-to-treat population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2747328|NCT00896363|Primary|Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42|The bech melancholia is sum of scores on 6 items- depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, somatic symptoms general (items 1, 2, 7, 8, 10 and 13 respectively). Each item having 5 responses. The items are rated on a scale of 0-4, where 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. Total possible score is 0-24. where the lowest possible score was 0, which represented an absence of depression and higher scores reflecting greater severity of diseases. Baseline was defined as the assessment done on Day 1. Change from baseline was the difference between BECH 6 scale at the time point being analyzed to randomization.|Baseline (Day 1, pre-dose), Day 14 and Day 42|Intent-to-treat population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2747329|NCT00896363|Primary|Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42|HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items were rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill). The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1 (pre-dose). Change from baseline in total Score was the difference between HAMD total score at the time point being analyzed to Day 1.|Baseline (Day 1, pre-dose), Day 14 and Day 42|Intent-to-treat population comprised of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2747330|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
2747331|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
2749925|NCT00877604|Secondary|Incidence and Severity of Adverse Events, and Their Relationship to Treatment|laboratory tests, patients' reports and the investigator's judgments|1 year|||||||
2747332|NCT00896337|Secondary|Walking Impairment Questionnaire Score-Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.|||units on a scale||Standard Deviation|Mean
2747333|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
2747334|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
2747335|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.|||units on a scale||Standard Deviation|Mean
2747336|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
2747337|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
2747338|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.|||units on a scale||Standard Deviation|Mean
2747339|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.|||percentage of lesions|Participants||Number
2747340|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.|||percentage of lesions|Participants||Number
2747341|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable|||percentage of lesions|Participants||Number
2747342|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable|||percentage of lesions|Participants||Number
2747766|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||(10^9 cells/L)||Full Range|Mean
2747343|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.|||percentage of lesions|Participants||Number
2747344|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.|||percentage of lesions|Participants||Number
2747345|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable|||percentage of lesions|Participants||Number
2747346|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable|||percentage of lesions|Participants||Number
2747347|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.|||ratio|Participants|Standard Deviation|Mean
2747348|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.|||ratio|Participants|Standard Deviation|Mean
2747349|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||ratio|Participants|Standard Deviation|Mean
2747350|NCT00896337|Secondary|Ankle-Brachial Index|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Hospital Discharge (1-2 days post-procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||ratio|Participants|Standard Deviation|Mean
2747351|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||ratio|Participants|Standard Deviation|Mean
2747352|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.|||percentage of lesions|Participants||Number
2747477|NCT00895895|Secondary|Percentage of Participants Who Were Responders at Week 24|Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.|Week 24|ITT; N=number of participants with evaluable data|||percentage of participants|||Number
2747353|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.|||percentage of lesions|Participants||Number
2747354|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.|||percentage of lesions|Participants||Number
2747355|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of lesions|Participants||Number
2747356|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of lesions|Participants||Number
2747357|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Very late stent thrombosis is defined as >365 days following the trial procedure."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable|||percentage of participants|||Number
2747358|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Very late stent thrombosis is defined as >365 days following the trial procedure."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable|||percentage of participants|||Number
2747359|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable|||percentage of participants|||Number
2747360|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable|||percentage of participants|||Number
2747361|NCT00896337|Secondary|Sub-acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure."|>24 Hours to <=30 Days Post-index procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable|||percentage of participants|||Number
2747362|NCT00896337|Secondary|Acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure."|24 Hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of participants|||Number
2747363|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.|||percentage of participants|||Number
2747498|NCT00895843|Secondary|Time to Rescue|Time taken for rescue medication requirement|Between 30mins and 48 hours|||||||
2747364|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.|||percentage of participants|||Number
2747365|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of participants|||Number
2747366|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|Post-procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of participants|||Number
2747367|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of participants|||Number
2747368|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.|||percentage of limbs|Participants||Number
2747369|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.|||percentage of limbs|Participants||Number
2747370|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of limbs|Participants||Number
2747371|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of limbs|Participants||Number
2747372|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.|||percentage of patients|||Number
2747373|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.|||percentage of patients|||Number
2747374|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable|||percentage of participants|||Number
2747375|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema"|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable|||percentage of participants|||Number
2747376|NCT00896337|Secondary|Procedure Success|Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).|In hospital (1-2 days post procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of participants|||Number
2749926|NCT00877604|Secondary|ALSFRS-R at Study End||1 year|||||||
2747378|NCT00896337|Secondary|Myocardial Infarction (MI)|Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.|Index hospitalization|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of participants|||Number
2747379|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.|||percentage of participants|||Number
2747380|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.|||percentage of participants|||Number
2747381|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.|||percentage of participants|||Number
2747382|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
2747383|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of participants|||Number
2747384|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.|||percentage of participants|||Number
2747385|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.|||percentage of participants|||Number
2747386|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.|||percentage of participants|||Number
2747387|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
2747388|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.|||percentage of participants|||Number
2747389|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.|||percentage of participants|||Number
2747390|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.|||percentage of participants|||Number
2747391|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
2747392|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of participants|||Number
2747393|NCT00896337|Primary|Device- and/or Procedure-related Major Adverse Events (MAE)|MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
2747394|NCT00896298|Secondary|Body Weight||4 months||||kg||Standard Deviation|Mean
2747395|NCT00896298|Secondary|Fasting Serum Glucose||4 months||||mg/dL||Full Range|Median
2747396|NCT00896298|Primary|HbA1c||4 months||||% of haemoglobin||Full Range|Median
2747397|NCT00896298|Primary|Fasting Serum Triglycerides||4 months||||mg/dL||Full Range|Median
2747398|NCT00896233|Primary|Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.|||percent treatment difference||95% Confidence Interval|Number
2747399|NCT00896233|Primary|Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.|||percent treatment difference||95% Confidence Interval|Number
2747400|NCT00896233|Primary|Repeated Mean Liver Elastic Stiffness (kPa) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.|||kPa||Standard Deviation|Mean
2747401|NCT00896233|Primary|Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.|||kPa||Standard Deviation|Mean
2747402|NCT00896168|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26|ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Millimeter/1 hour||Standard Deviation|Mean
2747403|NCT00896168|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 26|CRP is a protein found in the blood, the levels of which rise in response to inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. Here, 'N' signifies participants who were evaluated for this outcome measure.|||Milligram/Liter||Standard Deviation|Mean
2747499|NCT00895843|Secondary|Mean Pain Intensity|Mean VAS scores of pain intensity for each time points|30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery|||||||
2747500|NCT00895843|Primary|Number of Patients Needing Rescue Medication|Number of patients who required rescue medication within 6 hours|At 6 hours||||Participants|||Number
2747501|NCT00895830|Primary|Experienced Post-operative Nausea or Vomiting||24 hours|ITT|||participants|||Number
2747404|NCT00896168|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Units on a scale||Standard Deviation|Mean
2747405|NCT00896168|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 26|Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Minutes||Standard Deviation|Mean
2747406|NCT00896168|Secondary|Change From Baseline in Physicians' Global Disease Assessment at Week 26|"Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using 0=no active RA to 100=most serious active RA scale."|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Units on a scale||Standard Deviation|Mean
2747407|NCT00896168|Secondary|Change From Baseline in Participants' Global Disease Assessment at Week 26|"Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using 0 mm=very good to 100 mm=very poor scale."|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Units on a scale||Standard Deviation|Mean
2747408|NCT00896168|Secondary|Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26|Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Units on a scale||Standard Deviation|Mean
2747409|NCT00896168|Secondary|Change From Baseline in Tender Joints Count at Week 26|Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Tender joints||Standard Deviation|Mean
2747410|NCT00896168|Secondary|Change From Baseline in Swollen Joints Count at Week 26|Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Swollen joints||Standard Deviation|Mean
2747411|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response|ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Percentage of participants|||Number
2747412|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response|ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Percentage of participants|||Number
2747413|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response|ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|Full analysis set (FAS) included participants who received at least 1 dose of study medication and had post efficacy data.|||Percentage of participants|||Number
2747414|NCT00896064|Secondary|Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities|"Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.~Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening"|At 1 and 6 days post-booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747415|NCT00896064|Secondary|Number of Subjects With Any SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 30)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747416|NCT00896064|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747417|NCT00896064|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747418|NCT00896064|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747419|NCT00896064|Secondary|Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein|Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.|Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.|||Titers||95% Confidence Interval|Geometric Mean
2747420|NCT00896064|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins|Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD.|Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.|||LU/mL||95% Confidence Interval|Geometric Mean
2747421|NCT00896064|Primary|Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities|"Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.~Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening"|At Days 1 and 6 post-booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747422|NCT00896064|Primary|Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 30)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747423|NCT00896064|Primary|Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747424|NCT00896064|Primary|Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747425|NCT00896064|Primary|Number of Subjects With Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2747446|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747502|NCT00895817|Secondary|Endoscopic Change|Following therapy, resolution of EE findings will be assessed.|8 weeks|||||||
2747426|NCT00896051|Secondary|Time to Virologic Failure|The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Days||95% Confidence Interval|Median
2747427|NCT00896051|Secondary|Time to Confirmed Virologic Response|The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Days||95% Confidence Interval|Median
2747428|NCT00896051|Secondary|Change From Pre-Baseline in Log10 Viral Load Over Time|The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method.|Pre-Baseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||log10 (Copies/mL)||Standard Error|Mean
2747429|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method|The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48.|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Participants|||Number
2747430|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method|The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method.|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Particpants|||Number
2747431|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method|The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change).|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Participants|||Number
2747432|NCT00896051|Secondary|Change From Prebaseline in CD4+ Cell Count Over Time|The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method.|Prebaseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||CD4+ cell count||Standard Error|Mean
2747433|NCT00896051|Primary|Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48|The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change).|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Participants||95% Confidence Interval|Number
2747434|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/mL||Standard Deviation|Mean
2747435|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng/ml||Standard Deviation|Mean
2747436|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/ml||Standard Deviation|Mean
2747437|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng/ml||Standard Deviation|Mean
2747438|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/ml||Standard Deviation|Mean
2747439|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng/ml||Standard Deviation|Mean
2747440|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/mL||Standard Deviation|Mean
2747441|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||ng/ml||Standard Deviation|Mean
2747442|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.|||ng.h/mL||Standard Deviation|Mean
2747443|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.|||ng/ml||Standard Deviation|Mean
2747444|NCT00896038|Primary|PTSD Total Symptom Severity Score|PTSD total symptom severity was measured using the Clinician-Administered PTSD Scale (CAPS). This is a 30-item interview-based questionnaire that measures symptom severity during the past week. The total symptom severity score ranges from 0 (lowest symptom severity) to 136 (highest symptom severity).|Day 29 of the treatment period, 2 days after the final script presentation|The analysis included subjects who completed the CAPS at both baseline (Day 1) and Day 29, and who had data for the baseline covariates used in the analysis|||units on a scale||Standard Error|Mean
2747445|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747473|NCT00895934|Secondary|Disease Relapse||up to 2 years||||Participants|||Count of Participants
2747474|NCT00895934|Secondary|Number of Participants With Complete Remission|Efficacy Defined as Best Response Achieved During Study Treatment Measured by Complete Remission (CR) Rate|up to 3 years||||Participants|||Count of Participants
2747475|NCT00895934|Primary|Number of Participants With Dose-limiting Toxicity After the Vorinostat Dose||Up to 3 years||||participants|||Number
2747447|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747448|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747449|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747450|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747451|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747452|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747453|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747454|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747455|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747456|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747457|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747476|NCT00895934|Primary|Number of Participants With Dose-limiting Toxicity (Phase I)||42 days||||participants|||Number
2747503|NCT00895817|Secondary|Symptom Score|Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.|8 weeks|||||||
2749927|NCT00877604|Secondary|Survival Time From Starting of Study Medication Dosing (if Appropriate)||1 year|||||||
2747458|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747459|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747460|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
2747461|NCT00896025|Secondary|To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated.|2-year follow-up|Data was not collected since study was terminated, therefore there was no data to analyze.||||||
2747462|NCT00896025|Secondary|To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated.|1-year follow-up|Data was not collected since study was terminated, therefore there was no data to analyze.||||||
2747463|NCT00896025|Secondary|To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated, therefore no data to analyze.|3 Week follow-up|Data was not collected since study was terminated, therefore there was no data to analyze.||||||
2747464|NCT00896025|Primary|Survival Rate With or Without Transplant|The primary outcome is to compare all patients who survive (with or without transplant) to those who die.|2-year follow-up|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated.||||||
2747465|NCT00896025|Primary|Survival Rate With or Without Transplant|The primary outcome is to compare all patients who survive (with or without transplant) to those who die.|1-year follow-up|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated.||||||
2747466|NCT00896025|Primary|Survival Rate With or Without Transplant|The primary outcome is to compare all patients who survive (with or without transplant) to those who die.|3 Weeks|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Data was not collected since study was terminated, therefore there was no data to analyze.||||||
2747467|NCT00895947|Post-Hoc|Acute Respiratory Illness|"Number of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as febrile or afebrile depending on whether the subject reported the symptom of feverishness."|16 weeks||||participants|||Number
2747468|NCT00895947|Secondary|Incidence/Severity of Viral Respiratory Infections|Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection|16 weeks||||participants|||Number
2747469|NCT00895947|Secondary|Negative Events Related to Cold/Flu Symptoms|Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity|16 weeks||||participants|||Number
2747470|NCT00895947|Secondary|Impact of Cold/Flu Symptoms|Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.|16 weeks||||participants|||Number
2747471|NCT00895947|Secondary|Symptom Incidence/Severity|Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly|16 weeks||||participants|||Number
2747472|NCT00895947|Primary|Frequency of Influenza-like Illness|Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).|16 weeks|Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug|||participants|||Number
2747478|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24|CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
2747479|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Movement Time at Week 24|CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
2747480|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24|CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
2747481|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24|CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
2747482|NCT00895895|Secondary|Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24|CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||correct trials||Standard Deviation|Mean
2747483|NCT00895895|Secondary|Change From Baseline in CANTAB PRM-Percentage Correct at Week 24|CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||percentage of correct answers||Standard Deviation|Mean
2747484|NCT00895895|Secondary|Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24|CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
2747485|NCT00895895|Secondary|Change From Baseline in CANTAB SWM Strategy at Week 24|CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||boxes||Standard Deviation|Mean
2747486|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24|CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
2747487|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24|CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
2747488|NCT00895895|Secondary|Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24|CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
2747489|NCT00895895|Secondary|Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24|CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
2747490|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||correct choices||Standard Deviation|Mean
2747491|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||patterns||Standard Deviation|Mean
2747492|NCT00895895|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
2747493|NCT00895895|Secondary|Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24|Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.|Baseline, Week 24|ITT; N=number of evaluable participants|||participants|||Number
2747494|NCT00895895|Secondary|Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24|Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances|Baseline, Week 24|ITT; N=number of participants with evaluable data|||unit on a scale||Standard Deviation|Mean
2747495|NCT00895895|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24|"Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of Not Applicable was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL."|Baseline, Week 24|ITT; N=number of participants with evaluable data|||percentage of yes answers||Standard Deviation|Mean
2747496|NCT00895895|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24|14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.|Baseline, Week 24|Intent to treat (ITT) population: randomized participants who took at least one dose of study medication, had a baseline evaluation and had at least one on-treatment post-baseline evaluation for the ADAS-Cog; Number of Participants Analyzed (N): number of evaluable participants|||units on a scale||Standard Deviation|Mean
2747497|NCT00895843|Secondary|Pain Control/Relief|Patient satisfaction scores|48 hours after surgery (end of study)|||||||
2747504|NCT00895817|Primary|Number of Participants Who Responded|Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.|8 weeks|Sample size estimation was based on the assumptions:10% of the EE patients will respond to PPI compared to 55% of patients treated with steroids. Controlling the probability of a Type I error at alpha=0.05, a sample of 38 patients in the treatment groups (19 in each arm) will have 80% power to detect a difference in treatment response of 45%.|||participants|||Number
2747505|NCT00895752|Secondary|Extra-cellular Signal-relatedness Kinase (ERK)|ERK activations times, as defined as the time in minutes for ERK phosphorylation to reach the half maximal level.|Screen and Week 6||||minutes||Standard Deviation|Mean
2747506|NCT00895752|Secondary|The Social Reciprocity Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment.|Week 6||||units on a scale||Standard Deviation|Mean
2747507|NCT00895752|Secondary|The Peabody Picture Vocabulary Test|The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank.|Week 6||||units on a scale||Standard Deviation|Mean
2747508|NCT00895752|Secondary|The Clinical Global Impression - Severity Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|Week 6||||units on a scale||Standard Deviation|Mean
2747509|NCT00895752|Secondary|The ADHD Rating Scale|The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity|Week 6||||units on a scale||Standard Deviation|Mean
2747510|NCT00895752|Secondary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).|Week 6||||units on a scale||Standard Deviation|Mean
2747511|NCT00895752|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.|Obtained at Baseline and Week 6||||Units on a Scale||Standard Deviation|Mean
2747512|NCT00895752|Primary|Clinical Global Impression-Improvement (CGI-I)|The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse|Obtained at Week 6||||units on a scale||Full Range|Mean
2747513|NCT00895661|Secondary|Incidence of Severity of Infusion Reactions, Infections and Neutropenia|Toxicity grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening|24 months||||Participants|||Count of Participants
2747514|NCT00895661|Secondary|Progression-free Survival (PFS)|"Progressive Disease (PD) or Relapsed Disease (RD):~Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis.~>50% increase from nadir in the SPD of any previous lesions PFS is number of participants who have not died or had PD or RD."|5 years||||Participants|||Count of Participants
2747515|NCT00895661|Secondary|Overall Response Rate (ORR)|"Complete Response (CR): see definition in primary outcome~Partial Response (PR):~≥50% decrease in SPD of up to 6 largest dominant masses~No new sites of disease or increase in the size of the other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by at least 50% in the SPD.~Overall Response (OR) = CR + PR."|after a median number of 8 maintenance cycles, up to 24 weeks||||Participants|||Count of Participants
2747516|NCT00895661|Primary|Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas|"CR requires all of the following:~Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to <1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).~The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.~If bone marrow is known to be involved at the beginning, then repeat biopsy documents clearance"|after a median number of 8 maintenance cycles, up to 24 weeks||||Participants|||Count of Participants
2747517|NCT00895622|Secondary|Histopathologic Correlates of PFS Including Light Microscopy, Immunohistochemical Analysis, and Microarray Analysis||From registration to 3 years|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2749928|NCT00877604|Secondary|Time to Tracheostomy From Starting of Study Medication Dosing (if Appropriate)||1 year|||||||
2747518|NCT00895622|Secondary|Molecular Correlative Studies||From registration to 3 years|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2747519|NCT00895622|Secondary|Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping|A pathology review was conducted both by the institution and centrally, with three possible choices for grade / subtype: World Health Organization (WHO) Grade I / benign; WHO grade II / atypical; WHO grade III / anaplastic. Data is presented for all risk groups combined.|Baseline|Eligible patients with central and site reviews|||Participants|||Count of Participants
2747520|NCT00895622|Secondary|Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters||After treatment delivery||2021-05-31|05/2021||||
2747521|NCT00895622|Secondary|MRI Imaging Predictors as Assessed by Central Neuroradiology Review at Diagnosis, at Any Failure, and at 3 Years||From registration to 3 years||2021-05-31|05/2021||||
2747522|NCT00895622|Secondary|Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)|Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.|From registration to 3 years|Eligible patients who started study treatment and evaluable for 3-year progression-free survival|||percentage of participants||95% Confidence Interval|Number
2747523|NCT00895622|Secondary|Overall Survival Rate at 3 Years|Overall survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 3 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2747524|NCT00895622|Secondary|Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]|Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Late adverse events are those occurring more than 90 days from start of radiation therapy.|Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years.|Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.|||Participants|||Count of Participants
2747525|NCT00895622|Secondary|Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]|Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of radiation to 90 days.|Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.|||Participants|||Count of Participants
2747526|NCT00895622|Primary|Progression-free Survival Rate at 3 Years|Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival (PFS) rates are estimated using the binomial method.|From registration to 3 years|Eligible patients who started study treatment and evaluable for 3-year progression-free survival|||percentage of participants||95% Confidence Interval|Number
2747527|NCT00895583|Secondary|Percentage of Participants With Malignancy|Includes any adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
2747528|NCT00895583|Secondary|Percentage of Participants With Polyomavirus Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'polyomavirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
2747529|NCT00895583|Secondary|Percentage of Participants With Cytomegalovirus (CMV) Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'cytomegalovirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
2747530|NCT00895583|Secondary|Percentage of Participants With Infection|Includes adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
2747575|NCT00895245|Secondary|Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale|"The visual analog scale ranges from 0-100. 0 is labeled as no nausea and 100 is labeled as nausea as bad as it could be A score of < 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion."|120 hours following cisplatin infusion||||millimeters||Full Range|Mean
2747531|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes Receiving Treatment for Diabetes (Insulin and Non-Insulin)|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged between baseline and Month 12 or Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose ≥126 mg/dL after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization.|12 Months and 24 Months|Safety Population. Only participants with new-onset diabetes mellitus at the beginning of the analysis interval were included; those with pre-existing diabetes were excluded from the analysis.|||percentage of participants|||Number
2747532|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged from baseline to Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose greater than or equal to (≥)126 milligrams per deciliter (mg/dL) after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization, were included in the new-onset diabetes population. Events at Months 12 or 24 occurred from baseline to On-therapy Month 12 and from On-therapy Months 12 to 24, respectively.|From Baseline to On-Therapy Month 12, from Baseline to On-Therapy Month 24, and from On-Therapy Month 12 up to On-Therapy Month 24|Safety Population; participants at risk of new-onset diabetes mellitus at the beginning of the analysis interval were included and those with pre-existing diabetes were excluded from the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2747533|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Body Mass Index (BMI; in Kilograms Per Square Meter [kg/m^2])|BMI = Weight (kg)/(Height*Height) (square meters [m^2]).|Baseline, Month 12|Safety Population|||kg/m^2||Standard Error|Mean
2747534|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in HOMA-Beta Cell (HOMA-B; Fasting)|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA-B = 20 * insulin (µU/L) / fasting plasma glucose (mmol/L) minus (-) 3.5 Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population|||percentage beta cell function||Standard Error|Mean
2747535|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Homeostasis Model Assessment Insulin Resistance (HOMA-IR; Fasting)|"The HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA-IR = fasting plasma glucose (mmol/L) multiplied by (*) fasting plasma insulin in microunits per liter (µU/L) divided by (/) 22.5.~Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population|||insulin resistance score||Standard Error|Mean
2747536|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Waist Circumference(Centimeters [cm])||Baseline, Month 12|Safety Population|||cm||Standard Error|Mean
2747537|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Weight (Kilograms [kg])||Baseline, Month 12|Safety Population|||kg||Standard Error|Mean
2747538|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Insulin (Picomoles Per Liter [Pmol/L])||Baseline, Month 12|Safety Population|||pmol/L||Standard Error|Mean
2747539|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Glucose (mmol/L)||Baseline, Month 12|Safety Population|||mmol||Standard Error|Mean
2747540|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Hemoglobin A1C (Liter Per Liter [L/L])|Ratio of hemoglobin A1c to normal hemoglobin.|Baseline, Month 12|Safety Population|||L/L||Standard Error|Mean
2747541|NCT00895583|Secondary|Percentage of Participants Requiring Treatment for Stomatitis by Treatment Type|Included treatments (analgesics, dental paste, topical antifungal, topical steroids, or other) prior to randomization, during the on-therapy period (up to 19 to 21 months post-randomization) and the off-therapy period (up to 24 months post-transplantation).|On-Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population|||percentage of participants|||Number
2747542|NCT00895583|Secondary|Percentage of Participants With Stomatitis|Includes adverse events based on categorization by the investigator as stomatitis, regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA)|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
2747543|NCT00895583|Secondary|Percentage of Participants With Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Block (ARB) Use|Included ACEI or ARB use prior to randomization, during the on-therapy period (up to 19 to 21 months post randomization) and the off-therapy period (up to 24 months post-transplantation).|Pre-randomization, On-Therapy Period (up to 21 months post-randomization), and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population|||percentage of participants|||Number
2747544|NCT00895583|Secondary|Spot and 24 Hour Urine Protein to Creatinine Ratio (UPr/Cr)|Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline and Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||UPr/Cr||Standard Deviation|Mean
2747545|NCT00895583|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication, Diabetes Agents, Lipid-Lowering Agents, or Erythropoiesis Stimuating Agents (ESAs)||Baseline, Months 12 and 24|ITT Population|||percentage of participants|||Number
2747546|NCT00895583|Secondary|Change From Baseline (Pre-Randomization) to 12 and 24 Months Post-Transplantation in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L])|Parameters assessed included total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C); collected when participant was in a fasting state.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||mmol/L||Standard Error|Mean
2747576|NCT00895245|Secondary|Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)||25-120 hours following cisplatin infusion||||Participants|||Count of Participants
2749929|NCT00877604|Secondary|SF-36 Quality of Life Rating Scale||1 year|||||||
2749930|NCT00877604|Secondary|Forced Vital Capacity (FVC) %||1 year|||||||
2747547|NCT00895583|Secondary|Percentage of Participants With Anemia, Thrombocytopenia, or Leukopenia|Anemia was defined as hemoglobin less than or equal to (≤)10 grams per deciliter (g/dL); leukopenia was defined as white blood cell (WBC) count ≤2000 per cubic millimeters (/mm^3); and thrombocytopenia was defined as platelets ≤100,000/mm^3. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2747548|NCT00895583|Secondary|Percentage of Participants With Antibody Use in Treatment of Acute Rejection|Number of participants who experienced an adverse event (AE) of rejection was used as the denominator in the determination of percentage of participants with antibody use in treatment of acute rejection.|On Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|Safety Population; only participants with an AE of rejection were included in the analysis.|||percentage of participants|||Number
2747549|NCT00895583|Secondary|Number of Participants With BCAR by Severity of First BCAR and Time of Onset From Post-Randomization to 6, 12, 18, and 24 Months Post-Transplant|BCAR was categorized as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (moderate), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category.|Months 6, 12, 18, and 24|ITT Population|||participants|||Number
2747550|NCT00895583|Secondary|Percentage of Participants With First On-Therapy BCAR From Transplantation Occurring at 12 and 24 Months|Defined as the first BCAR occurring during the On-Therapy period based on the ITT population. Time to first BCAR was the days from transplantation to the date of BCAR.|Months 12 and 24|ITT Population|||percentage of participants|||Number
2747551|NCT00895583|Secondary|Percentage of Participants With BCAR Post-Randomization to 6, 12, 18, and 24 Months Post-Transplantation|BCAR was defined according to updated Banff criteria (2007) for renal allograft rejection.|Post-Randomization to 6, 12, 18, and 24 months Post-Transplantation|ITT Population|||percentage of participants|||Number
2747552|NCT00895583|Secondary|Percentage of Participants With Graft Loss (Including Death) at 12 and 24 Months Post-Randomization|Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for ≥56 days with no return of graft function), or death.|Post-randomization to Months 12 and 24 Post-Transplantation|ITT Population|||percentage of participants|||Number
2747553|NCT00895583|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection (BCAR), Graft Loss, or Death From Randomization to 24 Months Post-Transplantation|Biopsy-confirmed acute rejection was defined according to updated Banff criteria (2007) for renal allograft rejection. Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for greater than or equal to [≥]56 days with no return of graft function), or death.|Post-randomization to Month 24 post-transplantation|ITT Population|||percentage of participants|||Number
2747554|NCT00895583|Secondary|Change From Randomization in Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in mcmol/L. Baseline was defined as the last assessment prior to first administration of study drug.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.|||mcmol/L||Standard Error|Mean
2747555|NCT00895583|Secondary|Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in micromillimoles per liter (mcmol/L). Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.|||mcmol/L||Standard Deviation|Mean
2747556|NCT00895583|Secondary|Slope of Calculated GFR (MDRD) From Randomization to 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Timepoints were calculated as study days, relative to the time of randomization of study medication. All available on-therapy values were included. Observed data were multiplied by a scale factor of 365, expressing the slope as an annual change.|Baseline, Month 24|On-Therapy analysis of the slope comprised the data collected from the on-therapy evaluations for all the participants in the ITT population; data collected from participants receiving sirolimus during the first 3 weeks post-randomization for safety monitoring were excluded from the analysis.|||mL/min/1.73 m^2 per year||95% Confidence Interval|Mean
2747557|NCT00895583|Secondary|Change From Randomization in Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Error|Mean
2747558|NCT00895583|Secondary|Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. number (n)=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
2747559|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥10 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.|||percentage of participants|||Number
2747577|NCT00895245|Primary|Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen|Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.|120 hours following cisplatin infusion||||Participants|||Count of Participants
2747560|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥7.5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.|||percentage of participants|||Number
2747561|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation (Intent-to-Treat [ITT] Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population: all randomized participants who received at least 1 dose of the assigned therapy after randomization. Missing GFR was imputed as follows: 1) GFR equals (=)0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.|||percentage of participants|||Number
2747562|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Month 12|On-Therapy Population (12 Months): all randomized participants who remained on assigned study therapy through 12 months post-transplantation.|||percentage of participants|||Number
2747563|NCT00895583|Primary|Percentage of Participants With Improvement of Greater Than or Equal to [≥]5 Milliliters Per Minute Per 1.73 Square Meters (mL/Min/m^2) in Calculated Glomerular Filtration Rate (GFR) at 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the Modified Diet in Renal Disease (MDRD) equation using either serum creatinine traceable to isotope dilution mass spectrometry (IDMS) or serum creatinine not traceable to IDMS.|Baseline, Month 24|On-Therapy Population (24 Months): all randomized participants who remained on assigned study therapy through 24 months post-transplantation.|||percentage of participants|||Number
2747564|NCT00895531|Primary|Postoperative Pain|Pain as reported on a verbal rating scale ( VRS) (0-10, 0 = no pain, 10 = worse pain imaginable).|48 hours||||units on a scale||Standard Deviation|Mean
2747565|NCT00895453|Primary|Candida Culture Free After Maintenance Therapy|candida culture free (monthly vaginal cultures were obtained)|12 months||||participants|||Number
2747566|NCT00895414|Secondary|The Number of Participants With a Significant Increase or Decrease in Doxorubicin Hydrochloride Metabolite Levels With or Without Enalapril|Doxorubicin is metabolized to doxorubicinol. The effects of enalapril on doxorubicinol will be assessed. Statistical significance defined as a p < 0.05.|Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin||||Participants|||Count of Participants
2747567|NCT00895414|Secondary|The Number of Participants With a Significant Increase or Decrease in the Baseline Levels of Btype Natriuretic Peptide, Cardiac Troponins, and Urine Microalbumin With or Without Enalapril|Doxorubicin can induce changes in troponin, b-type natriuretic peptide and urine microalbumin. This analysis will determine whether enalapril prevents any of these changes. Statistical significance defined as a p < 0.05.|Baseline, 4, 24 and 48 hours after infusion of doxorubicin||||Participants|||Count of Participants
2747568|NCT00895414|Primary|Number of Patients With Doxorubicin Plasma Concentrations Demonstrating a Significant Increase or Decrease When Doxorubicin Was Given With Enalapril as Compared to When Doxorubicin Was Given Without Enalapril.|Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure. Each patient will have serial PKs performed twice - once with enalapril and once without enalapril. A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.|Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin||||participants|||Number
2747569|NCT00895310|Secondary|Duration of Stable Disease||From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Days||Full Range|Median
2747570|NCT00895310|Secondary|Progression Free Survival|Response Evaluation Criteria In Solid Tumors (RECIST) radiographic criteria for progression|From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Days||95% Confidence Interval|Median
2747571|NCT00895310|Secondary|PSA Response (>30% From Baseline)||From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Participants|||Count of Participants
2747572|NCT00895310|Primary|Prostate Specific Antigen (PSA) Response (>50% Reduction From Baseline)|Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a >=50% decrease in PSA.|From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Participants|||Count of Participants
2747573|NCT00895284|Primary|Total Procedure Time - Skin Incision to Skin Closure||At skin closure.|The study was terminated due to lack of funding; due to the small sample size, no analysis was done.||||||
2747574|NCT00895245|Secondary|Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire|"FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being none /not at all and 1 being a great deal. The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of >108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin."|5 days following cisplatin infusion|Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.|||units on a scale||Full Range|Mean
2747579|NCT00895232|Post-Hoc|Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.|Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect.|Baseline to Day 84|Only subjects who were evaluated at Baseline AND on Day 84|||percent of participants|||Number
2747580|NCT00895232|Primary|Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale|Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])|Baseline to Day 84|Only subjects who completed the IRLSSG Rating Scale at baseline AND on Day 84.|||units on a scale||Standard Deviation|Mean
2747581|NCT00895193|Primary|Maximum Flushing Severity Score|Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.|||units on a scale||Standard Deviation|Mean
2747582|NCT00895193|Primary|Duration of Flushing|The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.|||minutes||Standard Deviation|Mean
2747583|NCT00895193|Primary|Time to Flushing|The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.|||minutes||Standard Deviation|Mean
2747584|NCT00895193|Primary|Incidence of Flushing|Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.|Hourly for 6 hours on day of dosing|This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.|||participants|||Number
2747585|NCT00895180|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)|Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)|All enrolled participants who had any amount of ramucirumab and evaluable anti-ramucirumab antibodies.|||percentage of participants|||Number
2747586|NCT00895180|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies (ADA)|Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)|All enrolled participant who had any amount of olaratumab and evaluable anti-olaratumab antibody data.|||percentage of participants|||Number
2747587|NCT00895180|Secondary|Pharmacodynamics (PD) Profiles||Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion|Zero participants were analyzed for pharmacodynamic profile as the plasma collection procedure in this study was not fit for this purpose.||||||
2747588|NCT00895180|Secondary|PK: Cmax and Cmin of Olaratumab||Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion|All enrolled participants who received at least one dose of Olaratumab and had evaluable PK data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2747589|NCT00895180|Secondary|Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab||Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion|All enrolled participants who received at least one dose of ramucirumab and had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2747590|NCT00895180|Secondary|Median Overall Survival (OS)|OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive.|Start of Treatment to Death Up To 27 Months|All enrolled participants who received at least one dose of study drug. Participants censored in ramucirumab = 4 and olaratumab = 4.|||Weeks||95% Confidence Interval|Median
2747591|NCT00895180|Secondary|Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])|The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration.|Start of Treatment to PD Up To 20 Months|All enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2747592|NCT00895180|Secondary|Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)|The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Start of Treatment to End of Study (Up to 13 Months)|All enrolled participants who received at least one dose of study drug.|||participants|||Number
2747679|NCT00894647|Secondary|Percent of Subjects With Complete Clearance|Proportion of subjects who achieved complete clearance of all AK lesions, cryosurgery-treated AK lesions, and non cryosurgery-treated AK lesions from baseline to Week 26/EOS in the ITT population.|Week 26|Intent to treat (ITT) population, last observation carried forward (LOCF)|||percentage of participants||95% Confidence Interval|Number
2747593|NCT00895180|Primary|Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)|PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).|Start of treatment to PD or Death Up To 6 Months|All enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2747594|NCT00895154|Primary|Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score|The D-KEFS allows for the assessment of executive functions. There are 9 stand alone tests that can be individually or group administered. The Number-Letter Switching condition of the Trails Making sub-test specifically assesses flexibility of thinking on a visual-motor sequencing task. A participant's raw score (# of items answered correctly) is converted to a T score using tables provided in the manual. Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747595|NCT00895154|Primary|CVLT-C Trials 1-5 Recognition Discriminability T Score|TThe CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747596|NCT00895154|Primary|CVLT-C Trials 1-5 Long Delay Recall T Score|The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.|T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)||||scores on a scale||Standard Deviation|Mean
2747597|NCT00895154|Primary|CVLT-C Trials 1-5 Short Delay Recall T Score|The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747598|NCT00895154|Primary|CVLT-C Trials 1-5 Semantic Clustering T Score|The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The CVLT-C consists of five learning trials of 15 words which can be organized into three semantic categories. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747599|NCT00895154|Primary|California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score|The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747600|NCT00895154|Primary|Spelling T Score (WJ-III)|This sub-test measures a student's ability to write orally presented words correctly. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747601|NCT00895154|Primary|Math Fluency T Score (WJ-III)|This sub-test measures a student's ability to solve simple addition, subtraction and multiplication facts quickly. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747602|NCT00895154|Primary|Calculations T Score (WJ-III)|This sub-test measures a student's ability to perform paper and pencil math computations.A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747603|NCT00895154|Primary|Reading Fluency T Score (WJ-III)|This sub-test measures a student's ability to read simple sentences quickly. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747604|NCT00895154|Primary|Letter Word Identification T Score (WJ-III)|This sub-test measures a student's word identification skills. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747605|NCT00895154|Primary|Performance IQ (PIQ) (WASI)|The PIQ score is comprised from the Matrix Reasoning and Block Design subtests of the WASI-4. The raw scores from these subtests are converted to T scores using score charts in the manual. The T scores are summed together for a Performance Sum of T Scores. This score is converted to a Composite PIQ score using a score chart in the manual. Higher scores = better Performance IQ. Range = 45-160. Average = 100; standard deviation +/- 15.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747606|NCT00895154|Primary|Verbal IQ (PIQ) (WASI)|The VIQ score is comprised from the Vocabulary and Similarities subtests of the WASI-4. The raw scores from these subtests are converted to T scores using score charts in the manual. The T scores are summed together for a Verbal Sum of T Scores. This score is converted to a Composite VIQ score using a score chart in the manual. Higher scores = better Verbal IQ. Range = 45-160. Average = 100; standard deviation +/- 15.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747607|NCT00895154|Primary|Full Scale IQ (FSIQ) (WASI)|The WASI is a brief, reliable measure of intelligence. Participants engage in 4 subtests: Block Design, Vocabulary, Similarities, and Matrix Reasoning. Participants receive a raw score on each of these 4 subtests. This raw score is converted to a T score using a score chart in the WASI manual. The T scores from all 4 subtests are summed together to obtain a Full Scale Sum of T Scores. This Full Scale Sum of T Scores is converted to a Full Scale IQ-4 Composite Score using a score chart published in the WASI manual. Higher scores indicate better intelligence. FSIQ-4 Range: 40-160. Average FSIQ-4 =100, standard deviation is +/- 15.|After >/= 50 hours of tutoring||||scores on a scale||Standard Deviation|Mean
2747608|NCT00895037|Secondary|Investigator Assessment of Treatment Satisfaction of Participants|Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.|End of study visit (any time up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.|||participants|||Number
2747609|NCT00895037|Secondary|Participant Assessment of Satisfaction With Treatment Handling|Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.|End of study visit (any time up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.|||participants|||Number
2747610|NCT00895037|Secondary|Number of Participants With Change From Baseline Status in Days Missed From School or Work|Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.|Baseline until last visit (up to 87 months)|Analysis was performed on effectiveness analysis set. Here, 'N' signifies those participants who were evaluable for this outcome measure. For this outcome measure, data for Refacto AF: intermediate prophylaxis treatment arm could not be analyzed since all participants of this arm were neither working nor school going.|||participants|||Number
2747611|NCT00895037|Secondary|Mean Total Number of Bleeding Episodes Per Year in Participants|Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.|Baseline until last visit (up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.|||bleeding episodes per year||Standard Deviation|Mean
2747612|NCT00895037|Primary|Mean Total Number of Bleeding Episodes in Participants|Participants documented all bleeding episodes in a diary during the study.|Baseline until last visit (up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' (number of participants analyzed) = participants evaluable for this outcome measure.|||bleeding episodes||Standard Deviation|Mean
2747613|NCT00895037|Primary|Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay|FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.|Baseline until last visit (up to 87 months)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.|||participants|||Number
2747614|NCT00895037|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.|Baseline until last visit (up to 87 months)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.|||participants|||Number
2747615|NCT00895037|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline until last visit (up to 87 months)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.|||participants|||Number
2747616|NCT00895011|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Error|Least Squares Mean
2747617|NCT00895011|Primary|The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.|||Percentage of Sexual Attempts||Standard Deviation|Least Squares Mean
2747618|NCT00895011|Primary|Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
2747619|NCT00894933|Primary|Safety - Bladder Neck Contracture|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747620|NCT00894933|Primary|Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747621|NCT00894933|Primary|Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747622|NCT00894933|Primary|Safety - Urinary Retention Requiring Catheterization Post-Device Removal|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747623|NCT00894933|Primary|Safety - Creation of a False Passage|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747624|NCT00894933|Primary|Safety - Perforation of the Bowel or Bladder|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747625|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.|At Device placement|Subjects in whom device placement was attempted|||Minutes||Standard Deviation|Mean
2747626|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Total Device Placement Time|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.|At Device placement|Subjects in whom device placement was attempted|||Minutes||Standard Deviation|Mean
2747627|NCT00894933|Secondary|Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts||7-10 and 13 - 15 days post-Device placement|Subjects with successful device placement|||Participants|||Count of Participants
2747628|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Estimated Blood Loss|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.|At Device placement|Subjects in whom device placement was attempted|||cc||Standard Deviation|Mean
2747629|NCT00894933|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement|Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)|7-21 days post-Device placement||||Participants|||Count of Participants
2747630|NCT00894933|Primary|Successful Device Placement|Defined as the establishment of a water-tight anastomosis immediately post-Device placement.|At Device placement|Subjects in whom device placement was attempted (i.e. treated subjects)|||Participants|||Count of Participants
2747631|NCT00894933|Primary|Safety - Infection That Requires IV Antibiotics or Re-hospitalization|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
2747703|NCT00894413|Primary|Change in Immune Response After Tadalafil Administration|Median fold-change in immune response of T-cell expansion, delayed-type hypersensitivity reactions, CD4/CD69, CD8/CD69. A positive value indicates an increase in immune response.|Change from baseline to up to 14 days post-intervention|Data was not evaluable in 1/15 participants from the placebo group, 2/17 participants in the tadalafil group (for T-cell expansion, CD4/CD69, CD/CD69) and 1/17 for DTH area.|||fold change||Full Range|Median
2747632|NCT00894803|Post-Hoc|Modified Rankin Scale (mRS) of 0-1|"Modified Rankin Scale of 0 or 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of '6', and assigned the bad outcome. Also those lost to follow-up were assigned the bad outcome.~The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset||||participants|||Number
2747633|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days|"Study subjects with an NIH stroke scale score ≤ 2 points at 90 days from treatment onset compared to baseline value, those dead or unable to be evaluated by the NIHSS were assigned the bad outcome.~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|90 days from treatment onset||||participants|||Number
2747634|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 2|"Study subjects with an NIH stroke scale score of ≤ 2 at 24 hours from treatment onset, those dead (n=1) or sedated and unable to be evaluated by the NIHSS were assigned the bad outcome (n=5).~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 24 hours of treatment onset||||participants|||Number
2747635|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 5|"Study subjects with an NIH stroke scale score of ≤ 5 at 2 hours from treatment onset, those sedated and unable to be evaluated by the NIHSS were assigned the bad outcome (n=1).~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 2 hours of treatment onset||||participants|||Number
2747636|NCT00894803|Secondary|Glasgow Outcome Scale (GOS) of 1|"Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the bad outcome.~The Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead."|90 days from treatment onset||||participants|||Number
2747637|NCT00894803|Secondary|Barthel Index ≥ 95|"Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the bad outcome.~The Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent."|90 days from treatment onset||||participants|||Number
2747638|NCT00894803|Post-Hoc|Death Due to Stroke Within 90 Days of Treatment Onset|Death due to stroke within 90 days of treatment onset. Classified by blinded clinical investigators|Within 90 days of treatment onset||||participants|||Number
2747639|NCT00894803|Post-Hoc|Death Within 90 Days of Treatment Onset|Death due to any cause within 90 days of treatment onset|Within 90 days of treatment onset||||participants|||Number
2747640|NCT00894803|Other Pre-specified|Death Due to Stroke Within 7 Days of Treatment Onset|Death due to stroke within 7 days of treatment onset. Classified by blinded clinical investigators|Within 7 days of treatment onset||||participants|||Number
2747641|NCT00894803|Other Pre-specified|Death Within 7 Days of Treatment Onset|Death due to any cause within 7 days of treatment onset|Within 7 days of treatment onset||||participants|||Number
2747642|NCT00894803|Other Pre-specified|Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset|Any ICH observed on CT by the study site neuroradiologist and the independent study neuroradiologist; the central reader. The ICH would not be related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH,where judgment of significant neurological decline was made by the local clinical investigator. A third independent reader will make the final determination if there is disagreement between the treating investigator and the central reader|Within 7 days of treatment onset||||participants|||Number
2747643|NCT00894803|Other Pre-specified|Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 7 days of treatment onset||||participants|||Number
2747644|NCT00894803|Other Pre-specified|Serious Systemic Bleeding|Incidence of serious systemic bleeding defined as requiring transfusion of 2 or more units of packed red blood cells.|Within 7 days of treatment onset||||participants|||Number
2747645|NCT00894803|Primary|Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline|"Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of '6', and assigned the bad outcome. Also those lost to follow-up were assigned the bad outcome.~The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset||||participants|||Number
2747646|NCT00894803|Primary|Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset|Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 36 hours of initiation of therapy||||participants|||Number
2747704|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug.|||Participants|||Number
2747647|NCT00894790|Secondary|Change From Baseline in Participant's Responses to Neck Disability Index (NDI)|NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability.|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
2747648|NCT00894790|Secondary|Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire|Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
2747649|NCT00894790|Secondary|Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
2747650|NCT00894790|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours.|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
2747651|NCT00894790|Secondary|Change From Baseline on Physician's Global Assessment of Cervical Injury|Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
2747652|NCT00894790|Secondary|Change From Baseline in Patient Global Assessment of Cervical Injury|Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
2747653|NCT00894790|Secondary|Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement.|Baseline, Days 7, 14|Data not analyzed due to study termination.|||Percentage of participants|||Number
2747654|NCT00894790|Secondary|Change From Baseline on VAS-pain at Day 3 and Day 14|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Days 3, 14|Data not analyzed due to study termination.|||mm||Standard Deviation|Mean
2747655|NCT00894790|Primary|Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Day 7|Data not analyzed due to study termination.|||mm||Standard Deviation|Mean
2747656|NCT00894738|Primary|Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.||Week 1||||percent||Standard Deviation|Mean
2747657|NCT00894738|Primary|Carotid Artery Intima-media Thickness Measured by Ultrasonography.||Week 1||||millimeters||Standard Deviation|Mean
2747658|NCT00894699|Primary|Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)|The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.|4 hour study period|ITT population were those patients that took at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2747659|NCT00894686|Secondary|Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802|Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure.|From second booster vaccination up to 21-35 days after the vaccination|The safety population included any participant who had received the second booster dose.|||Participants|||Number
2747660|NCT00894686|Secondary|Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)|GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.|Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Fold rise||95% Confidence Interval|Geometric Mean
2747754|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
2747661|NCT00894686|Secondary|Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)|GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.|Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Fold rise||95% Confidence Interval|Geometric Mean
2747662|NCT00894686|Secondary|Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802|Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.|21-35 days after second TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Titers||95% Confidence Interval|Geometric Mean
2747663|NCT00894686|Secondary|Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.|21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Titers||95% Confidence Interval|Geometric Mean
2747664|NCT00894686|Secondary|Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802|Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.|21-35 days after second TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||VIE U/mL||95% Confidence Interval|Geometric Mean
2747665|NCT00894686|Secondary|Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.|21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||VIE U/mL||95% Confidence Interval|Geometric Mean
2747666|NCT00894686|Secondary|Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802|Seropositivity rate was reported as percentage of participants with ELISA level >126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|21-35 days after second TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2747667|NCT00894686|Secondary|Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with ELISA level greater than (>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2747668|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802|Seropositivity rate was reported as percentage of participants with NT level >=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|21-35 days after second TBE booster vaccination|Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2747669|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|118 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2750737|NCT00870870|Secondary|Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)||Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy|Zero participants analyzed. Analysis was not performed due to lack of an appropriate validated assay.||||||
2747670|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|106 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747671|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|94 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747672|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|82 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747673|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|70 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747674|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|58 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747675|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.|46 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747676|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level >=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.|38 months after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747677|NCT00894686|Primary|Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401|Seropositivity rate was reported as percentage of participants with NT level greater than equal to (>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.|21-35 days after first TBE booster vaccination|"Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2747678|NCT00894647|Secondary|Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)|"LSRs were assessed independently from AEs. The frequency and percentage of subjects, as well as the mean (SD) and median score for severity (none=0, mild=1, moderate=2, and severe=3), were summarized by treatment group and by visit for the following LSRs: erythema, edema, weeping/exudates, flaking/ scaling/dryness, and scabbing/crusting. Erosion and ulceration were also evaluated (none=0, erosion=1, and ulceration=2). A score of greater than 0 for the specified LSR was considered a treatment site reaction."|Weeks 2, 4, 6, 10, 14, 20, and 26|Safety population: all randomized subjects were presumed to have applied at least one application of study medication and were included in the safety population. This population was used for all safety analyses. Subjects were analyzed as treated.|||participants|||Number
2747680|NCT00894647|Primary|Change From Baseline in Percentage of Lesion Count|The primary efficacy endpoint was a comparison between the active and placebo treatment groups of percent change from baseline in the total AK lesion count at Week 26. All AK lesions on the face were included in the analysis—treated and untreated AK lesions at baseline (defined as the AK lesion count just prior to cryosurgery) and new lesions that appeared post-baseline.|Week 26|Intent to treat population, Last Observation Carried Forward (LOCF)|||percentage of lesion count||Standard Deviation|Mean
2747681|NCT00894556|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.|||attacks|Evaluable Attacks||Number
2747682|NCT00894556|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.|||attacks|Evaluable Attacks||Number
2747683|NCT00894543|Secondary|Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries|Change in daily hot flash bother between baseline & week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).~Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment."|||Scores on a scale||95% Confidence Interval|Mean
2747684|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash severity between baseline & week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).|||Scores on a scale||95% Confidence Interval|Mean
2747685|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).|||Scores on a scale||95% Confidence Interval|Mean
2747686|NCT00894543|Secondary|Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries|"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).|||Scores on a scale||95% Confidence Interval|Mean
2747687|NCT00894543|Primary|Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries|"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).|||Scores on a scale||95% Confidence Interval|Mean
2747688|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.|week 8 minus baseline||||Hot flashes/day||95% Confidence Interval|Mean
2747689|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.|week 4 minus baseline||||Hot flashes/day||95% Confidence Interval|Mean
2747690|NCT00894543|Secondary|Daily Hot Flash Bother, Recorded on Daily Diaries|"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).|||Scores on a scale||95% Confidence Interval|Mean
2747691|NCT00894543|Primary|Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries|Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.|Baseline||||Hot flashes/day||95% Confidence Interval|Mean
2747692|NCT00894517|Secondary|Change From Baseline in Normal Sperm Morphology|Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Percent||Standard Deviation|Mean
2747693|NCT00894517|Secondary|Change From Baseline in Total Sperm Motility|Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Percent||Standard Deviation|Mean
2747694|NCT00894517|Secondary|Change From Baseline in Ejaculatory Volume|Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||milliliters (mL)||Standard Deviation|Mean
2747695|NCT00894517|Secondary|Change From Baseline in Log Transformed Sperm Concentration|Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening).|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Unitless||Standard Deviation|Mean
2747696|NCT00894517|Primary|Percent Change in Total Sperm Count Per Ejaculate|Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Percent change||Standard Deviation|Mean
2747697|NCT00894504|Secondary|Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab|Median PFS (95% CI), months, reported by biomarker expression/mutation status for: EGFR, p53, PTEN, PIK3CA, KRAS|18 months|Excludes patients in the following categories due to insufficient data: PTEN status unknown, PIK3CA Status unknown and KRAS no mutation|||months||95% Confidence Interval|Median
2747698|NCT00894504|Secondary|Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity|Assessments made through analysis of treatment-related adverse events and serious adverse events|every 6 weeks until discontinuation of treatment, expected average of 18 months||||participants|||Number
2747699|NCT00894504|Secondary|Objective Response Rate and Clinical Benefit Rate|Estimated as the proportion of subjects who meet the criteria for complete or partial response (CR or PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - for target lesions assessed by MRI: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.|every 6 weeks until treatment discontinuation|All evaluable patients per RECIST v 1.1|||Participants|||Number
2747700|NCT00894504|Primary|Progression-free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions|every 6 weeks until treatment discontinuation||||Months||95% Confidence Interval|Median
2747701|NCT00894465|Secondary|Anxiety Score From the State-Trait Anxiety Inventory|The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. This questionnaire was used to evaluate the anxiety level of the parents of the children who randomized to versed or placebo.|At the time of the procedure||||units on a scale||Standard Deviation|Mean
2747702|NCT00894465|Primary|Anxiety Score From the Modified Yale Preoperative Anxiety Scale|The modified Yale preoperative scale consists of 5 categories (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Four of the five categories are scored between 1-4 points and one of the categories is scored from 1-6 points. The scores are divided by their number of possible points in their respective category and multiplied by 20 to get the final anxiety score which ranges from 20 to 100. Low numbers represent low anxiety and higher numbers represent high anxiety.|Waiting room, before catheterization, and after catheterization||||units on a scale||Standard Deviation|Mean
2747872|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.|||cells/μL||Standard Deviation|Mean
2747705|NCT00894387|Secondary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months|The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.|Baseline, 1 month, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.|||pg/mL||95% Confidence Interval|Least Squares Mean
2747706|NCT00894387|Primary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.|6 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.|||Participants|||Number
2747707|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months||12 months|Full ananlysis set included all randomized patients who had at least one dose of study drug.|||Participants|||Number
2747708|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|6 months|Full analysis set included all randomized patients who had taken at least one dose of drug.|||Participants|||Number
2747709|NCT00894387|Secondary|Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months|Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.|Baseline, 1 months, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.|||units on a scale||Standard Error|Least Squares Mean
2747710|NCT00894387|Secondary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.|12 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.|||Participants|||Number
2747711|NCT00894361|Primary|Knee Postoperative Range of Motion (ROM) at 2 Years|range of motion of the knee postoperatively at 2 years|2 years||||degrees||Standard Deviation|Mean
2747712|NCT00894361|Secondary|Survival of the Implants to Subject Death or Implant Removal||10 or more years|||||||
2747713|NCT00894322|Primary|Time to Maximum Concentration (Tmax) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Tmax was measured in hours (h). Exenatide was measured using a validated ELISA. Tmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||hours||Standard Error|Geometric Mean
2747714|NCT00894322|Primary|Maximum Concentration (Cmax) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Cmax was measured in pg/mL. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Cmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||pg/mL||Standard Error|Geometric Mean
2747723|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Heart rate was measured in beats per minute (bpm). In Cohort 2, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12||||bpm||Standard Deviation|Mean
2747755|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
2747715|NCT00894322|Primary|Average Exenatide Concentration (Cave) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) and Cave(0-tlast) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h), and AUC (0-tlast), respectively. Cave was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10 - Week 11; Week 10 - Week 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||pg/mL||Standard Error|Geometric Mean
2747716|NCT00894322|Primary|Area Under the Curve (AUC) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-6h) measured at Week 10, AUC (0-168h) steady state measured between Weeks 10 and 11, and AUC (0-tlast) for time interval between Weeks 10 and 12 (approximately336 hours) are presented below. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10-11; Weeks 10 - 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||pg*hr/mL||Standard Error|Geometric Mean
2747717|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Fasting Plasma Glucose in Participants With Diabetes (Cohort 2) for the ITT Population|Baseline was the last measurement at the screening visit. Fasting plasma glucose (FPG) was measured at screening, Day 1, Weeks 2, 4, 6, 8, 12, or early termination and reported in milligrams per deciliter (mg/dL).|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only participants in Cohort 2 were evaluated for this Outcome Measure.|||mg/dL||Standard Error|Least Squares Mean
2747718|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Body Weight in Participants With Diabetes (Cohort 2) in the ITT Population|Body weight was measured in kilograms (kg). Baseline was Day 1, last measurement prior to first dose of study drug. Body weight was measured at screening, Day 1, Weeks 4, 8, 12 or early termination and the LOCF approach was applied to estimate missing value at each post baseline timepoint.|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only Cohort 2 was analyzed for this outcome measure.|||kg||Standard Error|Least Squares Mean
2747719|NCT00894322|Secondary|Number of Participants Achieving HbA1c Less Than Equal to (<=) 6.5% and Less Than (<) 7% at Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. LOCF was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Week 12|ITT population included all participants treated with at least one dose of study drug. Only those ITT participants in Cohort 2 were analyzed.|||participants|||Number
2747720|NCT00894322|Secondary|Least Square Mean Change From Baseline in Hemoglobin A1c (HbA1c) to Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. Last observation carried forward (LOCF) was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug. This analysis was only done in Cohort 2 so the ITT population of Cohort 2 was available for analysis.|||Percent of hemoglobin||Standard Error|Least Squares Mean
2747721|NCT00894322|Primary|Antibody Titers for Participants With Treatment Emergent Positive Antibodies to Exenatide in Participants Who Received Exenatide in Cohorts 1 and 2|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1. Negative titers were assigned a value of 1 in order to calculate geometric mean. Geometric mean of reportable titers, by study week, are presented below.|Day 1 to Week 12|Only participants who received exenatide were analyzed (no placebo-treated participants were included). N=number of participants in each treatment at each visit and n= number of participants with reportable titers at the visit. Last visit=last visit with reportable titers.|||Reportable Titers||Standard Error|Geometric Mean
2747722|NCT00894322|Primary|Number of Participants With Hematology and Serum Chemistry Laboratory Values of Potential Clinical Importance in Cohorts 1 and 2 in ITT Population|Abbreviations: Upper Limit of Normal (ULN); milligram per deciliter (mg/dL); units per liter (U/L); micro liters (µL); creatine kinase (CK); gamma-glutamyltransferase (G-GT). Normal ranges = Hematocrit: 40.6-52.3% (male), 35.3-47.0 (female); Platelets 155-361*10^3/µL(male/female); Calcium: 8.6-10.4 mg/dL (male/female); CK: 43-350 U/L (male), 28-207 U/L (female); G-GT: 7-62 U/L (male/female); Glucose 73-105 mg/dL (male/female); Lipase 14-70 U/L (male/female); Uric acid: 3.5-7.8 mg/dL (male), 2.3-5.9 mg/dL (female). Blood samples for laboratories were collected at screening, Day 1, Weeks 4, 8, 12 or early termination. Value for potential clinical importance is presented in each category presented below.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.|||participants|||Number
2747749|NCT00893971|Secondary|Plasma Formoterol PK Parameters|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
2747724|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Blood pressures (diastolic and systolic) were measured in millimeters of mercury (mmHg). In Cohort 2, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2747725|NCT00894322|Secondary|Average Exenatide Concentration (Cave) of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single dose, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h) and was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.|||pg/mL||Standard Error|Geometric Mean
2747726|NCT00894322|Secondary|AUC (0 Hour to 168 Hour) for 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC (0-168 h) data represents average concentration rather than maximum concentration. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y and measured in pg*h/mL. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.|||pg*h/mL||Standard Error|Geometric Mean
2747727|NCT00894322|Primary|Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population|Concomitant medications are defined as those medications received on or after the date of the first injection on Day 1, including prior medications that continued past Day 1 and new concomitant medications. Participants may be counted in more than one medication class and no more than once in each class. Categories by Anatomical Therapeutic Chemical (ATC) classification using the World Health Organization (WHO) Drug Dictionary version C1, 01 March 2009. As per protocol, all participants in Cohort 1 could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide.|Day 1 to 12 weeks|ITT population included all participants treated with at least one dose of study drug.|||participants|||Number
2747728|NCT00894322|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population|Treatment emergent (TE)=occurs during or after treatment with study drug. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Participants experiencing multiple episodes of a given AE are counted once. Injection site AEs: adverse events that existed prior to Day 1 and worsened after the first administration at Day 1, or occurred after the first administration at Day 1 through Week 12, or after Study Termination if considered by investigator to be clinically significant.|Day 1 to Week12|ITT population included all participants treated with at least one dose of study drug.|||participants|||Number
2747729|NCT00894322|Primary|Time to Maximum Concentration (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time(t) = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 an the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Tmax was measured in hours and Tmax (0-8h) and (0-tlast) are presented below. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] and had reliable PK data.|Day 1, Week 12|PK evaluable population. n=number of participants who had reliable PK data available to be evaluated.|||hours||Standard Error|Geometric Mean
2747730|NCT00894322|Primary|Maximum Concentration (Cmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cmax was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 for the evaluation of the PK characteristics of plasma exenatide and had reliable PK data. Cmax (0-8h) and (0-tlast) are presented below.|Day 1, Week 12|PK evaluable population.|||pg/mL||Standard Error|Geometric Mean
2747750|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (ke)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||1/h||Standard Deviation|Mean
2747756|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)|12 hours|Safety population|||L/min||Full Range|Mean
2747731|NCT00894322|Primary|Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-8h) and (0-tlast) are presented below. Pharmacokinetic (PK) evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1, Week 12|PK evaluable population was analyzed. n in categories below = number of ITT participants with PK evaluable data.|||pg*h/mL||Standard Error|Geometric Mean
2747732|NCT00894244|Primary|The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)|The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment|immediately following treatment and 30 days after last treatment||||millimeters||95% Confidence Interval|Number
2747733|NCT00894166|Secondary|Continuous Abstinence From Smoking at 6 Months Post Quit.||continuous abstinence at 6 months post quit day||||percentage of subjects|||Number
2747734|NCT00894166|Secondary|Abstinence (7 Days) at 6 Months.||point abstinence (7 days) at 6 months post-quit date||||percentage of subjects|||Number
2747735|NCT00894166|Primary|Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)|A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence.|weeks 8-11 after quit date|All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment.|||percentage of subjects abstinent||95% Confidence Interval|Number
2747736|NCT00894127|Primary|Determine the Clinical Sensitivity and Specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay Using Sputum Specimens From Two Cohorts of Participants and Estimate the Required Sample Size to Finalize a Protocol for a Pivotal Study.|"Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer.~Testing for the study was performed at multiple locations to assess the efficacy of the CyPath Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts (smoker with clear Low dose CT scan or high-risk normals, and lung cancer confirmed by pathology or cancer)."|March 2011||||percentage|||Number
2747737|NCT00893997|Primary|Number of Patients With Clinical Response|Clinical response based on the International Working Group (IWG) Response Criteria in myelodysplastic syndromes (MDS): 'Complete Response' or Hematologic Improvement' and 'No Clinical Response'. Clinical responses as assessed by standard criteria with bone marrow biopsy, cytogenetic studies (standard chromosome banding) and molecular studies 3 weeks after the last vaccination.|At 29 weeks|Analysis on patients treated; study terminated early.|||participants|||Number
2747738|NCT00893997|Primary|Patient Immunologic Response|Patients assessed after 4th vaccination for immunologic response categorized as 'Immunologic-Responders' or 'Non-Responders.' Immune response defined as an increase of ≥ 0.5 PR1-HLA-A2 tetramer cells/μl compared to the pre study absolute PR1-HLA-A2 tetramer cells/μl. Time period 29 weeks after study entry, with week 0 corresponding to 1st injection, and 8th injection thus being given at week 25, 29 weeks corresponds to 13 weeks after receipt of a 4th injection.|29 weeks|Analysis on patients treated; study terminated early.|||participants|||Number
2747739|NCT00893984|Secondary|Number of Participants With Mild Symptoms|Mild symptoms include weight gain, edema, and headaches|30 Days||||participants|||Number
2747740|NCT00893984|Secondary|Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker||30 Days||||Participants|||Count of Participants
2747741|NCT00893984|Secondary|Number of Participants With Termination of Bystolic Stratified by Reason||30 Days||||Participants|||Count of Participants
2747742|NCT00893984|Primary|Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician||30 Days||||Participants|||Count of Participants
2747743|NCT00893971|Primary|Serum Potassium Change From Baseline||12 hours|All subjects in the Safety Population|||mmol/L||Full Range|Median
2747744|NCT00893971|Secondary|Plasma Formoterol PK Parameters (ke)|Pharmacokinetic parameters for plasma formoterol ke|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||1/h||Standard Deviation|Mean
2747745|NCT00893971|Secondary|Plasma Formoterol PK Parameters (Cmax)|Pharmacokinetic parameters for plasma formoterol Cmax|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||pg/mL||Standard Deviation|Mean
2747746|NCT00893971|Secondary|Plasma Formoterol PK Parameters (t1/2)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
2747747|NCT00893971|Secondary|Plasma Formoterol PK Parameters (Tmax)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
2747748|NCT00893971|Secondary|Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
2747767|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study Hematocrit|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||% of Red Blood Cells in the blood||Full Range|Mean
2747768|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All patients in the Safety Population that had a valid measurement for the parameter|||U/L||Full Range|Mean
2747769|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||µmol/L||Full Range|Mean
2747770|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All patients in the Safety Population that had a valid measurement for the parameter|||mmol/L||Full Range|Mean
2747771|NCT00893971|Primary|Symptoms of Tremor|Number of participants reporting tremor at 12 hours post-dose|12 hours|All subjects in the Safety Population|||Participants|||Number
2747772|NCT00893971|Primary|Symptoms of Dry Mouth|Number of participants reporting dry mouth at 12 hours post-dose|12 hours|All subjects in the Safety Population|||Participants|||Number
2747773|NCT00893789|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP, defined as last postbaseline observation, up to Week 12). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT=head, eyes, ears, nose, throat.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|For each category, only participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.|||participants|||Number
2747774|NCT00893789|Secondary|Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Shifts (normal and abnormal) from baseline to overall are summarized using participant counts. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|Participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.|||participants|||Number
2747775|NCT00893789|Secondary|Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure, ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure, ≥90 mm Hg plus increase of ≥10% from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
2747776|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Vital Sign Values|Criteria for clinically significant abnormal vital signs values: heart rate, ≤50 beats per minute (bpm) and decrease from baseline of ≥15 bpm; sitting systolic blood pressure, ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; sitting diastolic blood pressure, ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
2747777|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values|Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine >=2 units increase from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
2747778|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values|Normal ranges for hematology values: white blood cell (WBC) count, 3.8 - 10.7 x 10^9/L; absolute neutrophil count (ANC), 1.96 - 7.23 x 10^9/L. Participants may have had more than one clinically significant abnormal value.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
2747779|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values|Normal ranges for serum chemistry values: blood urea nitrogen (BUN), 1.43 - 8.57 mmol/L; uric acid, 124.91 - 493.68 μmol/L; aspartate aminotransferase (AST), 11 - 36 U/L; gamma-glutamyl transpeptidase (GGT), 10 - 61 U/L; total bilirubin, 3.42 - 20.52 μmol/L.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
2747780|NCT00893789|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs|AE=any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis (including hypomanic or manic episode), and seizure or suspected seizure were considered to be of potential clinical importance.|Screening through Week 12|Safety Analysis Set (all participants who received 1 or more doses of study drug).|||participants|||Number
2747781|NCT00893789|Secondary|Concomitant Medication Usage In ≥5% of Participants Throughout the Study|Therapeutic classification of concomitant medications used by ≥5% of participants throughout the study. Participants are counted only once in each therapeutic class category. Medications were included in the table if the proportion of participants in the combined armodafinil treatment group was ≥5%.|Screening through Week 12|All randomized participants|||participants|||Number
2747782|NCT00893789|Secondary|Plasma Concentrations of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) at Weeks 4, 8, and 12 (or Last Postbaseline Observation Up to Week 12)|To evaluate the impact of treatment with armodafinil on the pharmacokinetics of selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) (as appropriate), plasma concentrations at weeks 4, 8, and 12 (or last postbaseline observation) were to be assessed.|Weeks 4, 8, and 12 (or last postbaseline observation, up to Week 12)|Due to the limited samples available for measurement of concentrations of antidepressants in the study, the plasma concentrations of antidepressants were not measured. The planned pharmacokinetic evaluation of the impact of armodafinil treatment on the pharmacokinetics of selective antidepressants was not conducted.||||||
2747783|NCT00893789|Secondary|Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|NPSG continuously records normal and abnormal physiological activity during an entire night. It documents the adequacy of sleep, including the frequency, duration, and total amounts of stage 1-2, stage 3-4 (slow wave sleep), and rapid eye movement (REM) sleep.|Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Safety Analysis Set (all participants who received 1 or more doses of study drug); n=number of participants with data at given time point.|||minutes||Standard Deviation|Mean
2747784|NCT00893789|Secondary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression and scores less than 12 indicate mild depression."|Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Participants in the Safety Analysis Set (participants who received 1 or more doses of study drug) with a baseline S-HAM-D6 measurement; n=number of participants with nonmissing data at given time point.|||units on a scale||Standard Deviation|Mean
2747785|NCT00893789|Secondary|"Percentage of Participants Answering No to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)"|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). The number of participants answering 'no' to all 9 yes/no questions about suicidal behaviors, ideations, and acts are presented. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Safety analysis set (all participants who received 1 or more doses of study drug); n=all participants with a nonmissing value at given time point.|||percentage of participants|||Number
2747786|NCT00893789|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The patient's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered.|Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time point.|||units on a scale||Standard Deviation|Mean
2747787|NCT00893789|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk is low; 2 to 23, the risk is medium; and >23, the risk is high, for work instability. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability)."|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Participants in the Full Analysis Set (participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment) with a baseline TBI-WIS measurement; n=number of participants with values at given time points.|||units on a scale||Standard Deviation|Mean
2747797|NCT00893737|Secondary|Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)|Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)||||Units on a scale||95% Confidence Interval|Mean
2747809|NCT00893464|Primary|Recommended Phase 2 Dose (RP2D)|The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.|Baseline up to Treatment Cycle 45|Safety population included all participants who received at least 1 dose of ixazomib.|||mg/m^2|||Number
2747788|NCT00893789|Secondary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12|The CGI-C is the clinician's rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant's condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Weeks 2, 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with a nonmissing value at given time point.|||percentage of participants|||Number
2747789|NCT00893789|Secondary|Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, Weeks 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time points.|||minutes||Standard Deviation|Mean
2747790|NCT00893789|Primary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)|The CGI-C is the clinician's rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant's condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment).|||percentage of participants|||Number
2747791|NCT00893789|Primary|Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. If a participant did not fall asleep in 20 minutes, his/her sleep latency for that nap was set to 20 minutes. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with measurements at given time point.|||minutes||Standard Deviation|Mean
2747792|NCT00893763|Secondary|Serum Procalcitonin||5 days|||||||
2747793|NCT00893763|Secondary|Serum Cytokines||5 days|||||||
2747794|NCT00893763|Secondary|Endotracheal Tube Colonization|semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization.|24 hours|The subjects analyzed were a subset of subjects enrolled in the study from whom endotracheal tunes were obtainable for microbial culture post-intubation. Subset analysis was planned a priori.|||percentage of ET tubes colonized|||Number
2747795|NCT00893763|Primary|Development of VAP (Clinical Pulmonary Infection Score)|Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.|Baseline up to 5 days|Subjects who had complete CPIS data on admission to the study (Day 0) and subsequent complete CPIS data from day 2, 3, 4 or 5 (47 CHX & 47 control, 438 observations) were included in the analysis in accordance with intent to treat analysis principles.|||units on a scale||Standard Error|Mean
2747796|NCT00893737|Primary|Change in Scores From Completeness of Response Survey (CORS)|"CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.~The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication)."|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)||||Units on a scale||95% Confidence Interval|Mean
2747844|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2747798|NCT00893737|Secondary|Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan|CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)||||Percent of Participants|||Number
2747799|NCT00893464|Secondary|Overall Best Response|Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD. PD is any new lesion or increase by >50% of previously involved sites from nadir.|Baseline up to Cycle 45|Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 postbaseline disease assessment for analyses of response.|||participants|||Number
2747800|NCT00893464|Secondary|TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib|TEmax: Time to reach the maximum observed effect (Emax), equal to time (hours) to Emax.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.|||hr||Full Range|Median
2747801|NCT00893464|Secondary|Emax: Maximum Observed Effect for Ixazomib|Emax is the maximum inhibition of 20S proteasome activity in whole blood.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.|||percentage of inhibition||Standard Deviation|Mean
2747802|NCT00893464|Secondary|CLr: Renal Clearance|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr).|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. CLr is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.|||L/hr||Standard Deviation|Geometric Mean
2747803|NCT00893464|Secondary|Fe (0-4): Fraction of Dose Excreted Unchanged in Urine From 0 to 4 Hours Postdose|Fe (0-4) is the fraction of the dose excreted unchanged in the urine from 0 to 4 hours postdose, calculated as percentage of the exact dose administered.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population was defined as participants who had sufficient dosing data and ixazomib concentration-time data to permit the calculation of PK parameters where Days 1 and 15 assessments were available.|||percentage of dose||Standard Deviation|Geometric Mean
2747804|NCT00893464|Secondary|Ae (0-4): Amount of Drug Excreted in Urine From 0 to 4 Hours Postdose|Ae (0-4) is the total amount of drug excreted in the urine from 0 to 4 hours postdose.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.|||nanogram||Standard Deviation|Geometric Mean
2747805|NCT00893464|Secondary|Rac: Accumulation Ratio for Ixazomib|Rac was estimated as the ratio of AUC (0-168) on Day 15 and AUC (0-168) on Day 1. AUC (0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Rac is reported for ixazomib 1.4, 2.34 and 3.11 mg/m^2 groups only as it could not be estimated for the other dosing groups.|||ratio||Standard Deviation|Geometric Mean
2747806|NCT00893464|Secondary|Terminal Phase Elimination Half-life (T1/2) for Ixazomib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Cycle 1 Day 15: Predose and at multiple time points (up to 336 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters.T1/2 is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.|||hr||Standard Deviation|Geometric Mean
2747807|NCT00893464|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration time-curve from time 0 to 168 hours postdose|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. AUC(0-168) is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
2747808|NCT00893464|Secondary|C0: Initial Plasma Concentration After Bolus Intravenous Administration|C0 is the plasma drug concentration at time zero following bolus intravenous injection, obtained from the plasma concentration-time curve.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 336 hours postdose)|The pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2747845|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2747810|NCT00893464|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of ixazomib that generated dose limiting toxicity (DLT) during Cycle 1 in 0 of 3 or 1 of 6 participants. DLT defined as any of the following considered possibly related to therapy by investigator: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; platelet count <25,000 cells/mm^3; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by maximal supportive therapy; Grade 3 QTc prolongation>500 millisecond (msec);any >=Grade 3 nonhematologic toxicity except arthralgia/myalgia; <1 week fatigue; delay in the initiation of the subsequent therapy cycle by >=7 days ; other Grade 2 ixazomib-related nonhematologic toxicities requiring therapy discontinuation.|Treatment Cycle 1|DLT-Evaluable Population included participants who received all Cycle 1 doses of MLN9708 and who completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.|||mg/m^2|||Number
2747811|NCT00893464|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, weight, systolic and diastolic blood pressure and heart rate.|Baseline and Days 1, 8, 15 of each treatment cycle up to 45 treatment cycles|Safety population included all participants who received at least 1 dose of ixazomib.|||participants|||Number
2747812|NCT00893464|Primary|Number of Participants Reporting at Least 1 TEAE Related to Laboratory Assessments|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology, clinical chemistry and urinalysis were performed. TEAEs related to laboratory assessment observed at any time-points were reported under 3 system organ classes: blood and lymphatic system disorders, metabolism and nutrition disorders, and investigations.|Baseline and Days 1, 8, and 15 of each treatment cycle (up to Cycle 45)|Safety population included all participants who received at least 1 dose of ixazomib.|||participants|||Number
2747813|NCT00893464|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of ixazomib.|||participants|||Number
2747814|NCT00893152|Primary|Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment|"This is qualitative research. Outcomes were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members."|During the 1-1.5 hour interviews|Participants in focus group or individual qualitative interviews|||participants|||Number
2747815|NCT00893113|Secondary|Change in Total International Index of Erectile Function (IIEF) Score|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.|||Change in Total IIEF Score from Baseline||Standard Deviation|Mean
2747816|NCT00893113|Secondary|Changes in American Urological Association (AUA) Symptom Index|The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.|||Change in AUA Score From Baseline||Standard Deviation|Mean
2747817|NCT00893113|Primary|Change From Baseline Erectile Function Domain of the International Index of Erectile Function|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.|||Change in EF Domain Score from Baseline||Standard Deviation|Mean
2747818|NCT00893074|Secondary|Heart Rate|Heart rate measured after acute cannabis exposure|Assessed on Day 5 of dronabinol maintenance||||beats per minutes||Standard Error|Mean
2747819|NCT00893074|Primary|"Subjective Drug Effect After Smoked Marijuana"|Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect|Day 5 of the Dronabinol abstinence period||||mm of subjective drug effect||Standard Error|Mean
2747820|NCT00893074|Primary|Peak Effect of Marijuana Withdrawal|Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).|Day 5 of the Dronabinol abstinence period||||units on a scale||Standard Error|Mean
2747821|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||95% Confidence Interval|Number
2747822|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||95% Confidence Interval|Number
2747823|NCT00892957|Secondary|Laboratory Values Over Time: International Normalized Ratio(INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||ratio||Full Range|Median
2747824|NCT00892957|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||seconds||Full Range|Median
2747825|NCT00892957|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||U/L||Full Range|Median
2747826|NCT00892957|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||U/L||Full Range|Median
2747827|NCT00892957|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||mg/dL||Full Range|Median
2747828|NCT00892957|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||x10^3/µl||Full Range|Median
2747829|NCT00892957|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||x10^3/µl||Full Range|Median
2747830|NCT00892957|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||x10^6/µl||Full Range|Median
2747831|NCT00892957|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||percentage of red blood cells in blood||Full Range|Median
2747832|NCT00892957|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||g/dL||Full Range|Median
2747833|NCT00892957|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set|||percent change||Full Range|Median
2747834|NCT00892957|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||breaths per minute||Full Range|Median
2747835|NCT00892957|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set|||percent change||Full Range|Median
2747836|NCT00892957|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||beats per minute||Full Range|Median
2747837|NCT00892957|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set|||percent change||Full Range|Median
2747838|NCT00892957|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||mm Hg||Full Range|Median
2747839|NCT00892957|Secondary|Number of Participants With Infections by Grade|"Infections were recorded according to:~Grade I: only dermis affected~Grade II: infection invades subcutaneous region but not the arterial implant~Grade III: the arterial implant is infected"|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set|||participants|||Number
2747840|NCT00892957|Secondary|Percentage of Participants With Infection at the Surgical Site||post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set|||percentage of participants||95% Confidence Interval|Number
2747841|NCT00892957|Secondary|Percentage of Participants With Graft Occlusion|Determined clinically and defined as absence of blood flow through the graft.|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set|||percentage of participants||95% Confidence Interval|Number
2747842|NCT00892957|Secondary|Percentage of Participants With Postoperative Rebleeding|Any rebleeding requiring surgical re-exploration|Postoperative through day 30 ± 5|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2747843|NCT00892957|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2752087|NCT00859651|Primary|Change in Serum 25(OH)D|25(OH)D level at the end of one year intervention|Baseline to 1 year|Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).|||ng/ml||Standard Deviation|Mean
2747846|NCT00892957|Primary|Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|4 minutes post start of treatment application|Intent to Treat|||Percentage of participants||95% Confidence Interval|Number
2747847|NCT00892775|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.|From first study dose (Day 0) until study end (Week 18)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2747848|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.|Within 43 days (Days 86-128) after second vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2747849|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.|Within 43 days (Days 0-42) after first vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2747850|NCT00892775|Secondary|Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes|Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.|||Participants|||Count of Participants
2747851|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.|||Participants|||Count of Participants
2747852|NCT00892775|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects,with the symptom sheet filled-in.|||Participants|||Count of Participants
2747853|NCT00892775|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/ spontaneously painful. Grade 3 redness/ swelling = redness/ swelling spreading beyond 20 millimeters (mm) of injection site.|Within 4 days after each vaccination (Days 0-3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.|||Participants|||Count of Participants
2747854|NCT00892775|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.|At 42-56 days after the first and second dose of study vaccine(s).|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.|||Titres||95% Confidence Interval|Geometric Mean
2747855|NCT00892775|Secondary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42-56 days after the second dose of study vaccine (Week 18)|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.|||Participants|||Count of Participants
2747866|NCT00892710|Primary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all enrolled patients whether they recieved treatment or not|||months||95% Confidence Interval|Median
2752088|NCT00859638|Secondary|Eight Foot Walk Test||4 months|||||||
2747856|NCT00892775|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42-56 days after the first dose of study vaccine (Week 6)|The According-to-protocol (ATP) cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received vaccine according to their random assignment, who had not received a vaccine forbidden in the protocol and for whom pre/ post-vaccination serology results were available.|||Participants|||Count of Participants
2747857|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters cubed||Standard Deviation|Mean
2747858|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
2747859|NCT00892723|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
2747860|NCT00892723|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Units on a scale||Standard Deviation|Mean
2747861|NCT00892710|Secondary|6-month and 12-month Overall Survival Probability|Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|12 months|Includes all enrolled patients, whether or not they received treatment|||probability out of 1||95% Confidence Interval|Number
2747862|NCT00892710|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all enrolled patients, whether or not they were treated|||months||95% Confidence Interval|Median
2747863|NCT00892710|Secondary|Time to Treatment Failure (TTTF)|Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.|18 months|Includes all treated patients|||months||Full Range|Median
2747864|NCT00892710|Secondary|Time to Progression (TTP)|The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all treated patients|||months||95% Confidence Interval|Median
2747865|NCT00892710|Secondary|Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all treated patients|||participants|||Number
2752089|NCT00859638|Secondary|Balance Screen||4 months|||||||
2752090|NCT00859638|Secondary|Primary Care Resources and Supports||4 months|||||||
2747873|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 24|The change from baseline in CD4 cell count at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.|||cells/μL||Standard Deviation|Mean
2747874|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
2747875|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 24|The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
2747876|NCT00892437|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set|||percentage of participants|||Number
2747877|NCT00892437|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.|Week 24|ITT Analysis Set: participants who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
2747878|NCT00892281|Secondary|Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)|Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst.|Baseline to Week 12||||participants|||Number
2747879|NCT00892281|Secondary|Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA.|Baaseline to Week 12||||participants|||Number
2747880|NCT00892281|Primary|Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.|Baseline to Week 12|Per protocol|||participants|||Number
2747881|NCT00892177|Secondary|Objective Response (Phase II)|Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher's Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.|||percentage of participants||95% Confidence Interval|Number
2747882|NCT00892177|Secondary|Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)|"FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very Much. Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10."|Baseline to cycle 10 (20 weeks).|All Phase II patients that began treatment and submitted at least one FACT-Br questionnaire were included in this analysis.|||units on a scale||Standard Deviation|Mean
2747883|NCT00892177|Secondary|Time-to-disease Progression (Phase II)|Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.|||months||95% Confidence Interval|Median
2747884|NCT00892177|Secondary|Overall Survival (Phase II)|Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.|||months||95% Confidence Interval|Median
2747900|NCT00892047|Primary|Weight|Weight change in kilograms|Baseline through12 weeks|The number of participants analyzed is lower due to missing data attributable to dropouts. The information obtained is from figure 3B in the manuscript|||kilograms||Standard Deviation|Mean
2747901|NCT00892047|Primary|Akathisia|Percentage of participants who developed clinically significant akathisia.|12 weeks||||percentage of participants|||Number
2752091|NCT00859638|Secondary|Patient Assessment of Chronic Illness Care||4 months|||||||
2747885|NCT00892177|Secondary|Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)|"Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1=Mild symptoms, 2= Moderate, 3=Severe, 4=Life-threatening, and 5=Death. The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section."|Up to 3 years|All Phase II patients treated and evaluated for adverse events are included in this Phase II endpoint analysis.|||participants|||Number
2747886|NCT00892177|Primary|Progression-free Survival at 6 Months (PFS6) (Phase II)|The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method.|6 months|All patients that received treatment and were eligible for assessment were included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2747887|NCT00892177|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I)|The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT. > Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|14 days|Adverse event information is available for 4 patients on study 1 dose level 1 (with 1 being a MTD replacement due to disease progression prior to completing cycles 1 and 2).|||participants who developed DLTs|||Number
2747888|NCT00892151|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3|"User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.|||participants|||Number
2747889|NCT00892151|Secondary|Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:~= Very Simple~= Simple~= Neither Simple nor Difficult~= Difficult~= Very Difficult"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.|||percentage of participants|||Number
2747890|NCT00892151|Primary|Number of Participants Rated Successful (<=3) at Performing Specific Tasks|"Study staff rated participants on their success at perfoming specific tasks. The rating scale was:~= Successful~= Successful after being referred to user instructions~= Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~= Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)~= Problem encountered with software"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.|||participants|||Number
2747891|NCT00892099|Secondary|Parathyroid Hormone|serum PTH levels (pg/mL)|every 4 weeks for 12 weeks|Subject receiving treatment|||pg/mL||Standard Error|Mean
2747892|NCT00892099|Secondary|Serum 1,25(OH)2 Levels|serum 1,25(OH) vitamin D levels (pg/mL)|At week 12|Subject receiving treatment|||pg/mL||Inter-Quartile Range|Median
2747893|NCT00892099|Secondary|Serum 25-OH Vitamin D|serum 25-OH vitamin D levels (ng/mL)|every 4 weeks for 12 weeks|Subject receiving treatment|||ng/mL||Standard Error|Mean
2747894|NCT00892099|Secondary|Serum Phosphate|serum phosphate levels (mmol/L)|every 4 weeks for 12 weeks|Subject receiving treatment|||mmol/L||Standard Error|Mean
2747895|NCT00892099|Secondary|Serum Calcium|serum calcium levels (mg/dL)|every 4 weeks for 12 weeks|Subject receiving treatment|||mg/dl||Standard Error|Mean
2747896|NCT00892099|Primary|Serum 25D Level||12 weeks||||ng/ml||Standard Deviation|Mean
2747897|NCT00892047|Secondary|QTc Prolongation on EKG (to Greater or Equal to 480 Msec)|percentage of participants|12 weeks|We had a smaller number of participant observations due to dropouts and missing data. This data is in Table 3 of the manuscript.|||percent of participants|||Number
2747898|NCT00892047|Secondary|Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment|percentage of participants who reported suicidal ideation during treatment but not at baseline|12 weeks|It is a smaller number of participants restricted to those who did not report any suicidal ideation at baseline. This is in Table 3of the manuscript|||percent of participants|||Number
2747899|NCT00892047|Primary|Parkinsonism|Percentage of participants who develop signs of parkinsonism|12weeks|We have a lower number of participants analyzed due to dropouts and missed assessments.|||percentage of participants|||Number
2752092|NCT00859638|Secondary|Two Minute Walk Test||4 months|||||||
2752093|NCT00859638|Secondary|Grip Strength||4 months|||||||
2747902|NCT00892047|Primary|Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS.|12 weeks||||percentage of participants|||Number
2747903|NCT00892008|Primary|Discontinuations Due to Adverse Events|Discontinuations due to adverse events by MedDRA system organ class and preferred term.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Safety population: all subjects who took at least one dose of study medication.|||participants|||Number
2747904|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit|Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747905|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist|Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747906|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747907|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747908|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747909|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747910|NCT00892008|Secondary|VAS Pain Score at Baseline and Final Visit|VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.|Baseline, Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747911|NCT00892008|Secondary|VAS Pain Score at Baseline (BL) and Second Visit|VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .|Baseline, Second Visit (Week ≥ 2)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
2747912|NCT00892008|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit.|||scores on scale||Standard Deviation|Mean
2752094|NCT00859638|Secondary|Rapid Assessment of Physical Activity||4 months|||||||
2747913|NCT00892008|Primary|Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)|Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.|Baseline through Final Visit (Week 4)|Safety population: all subjects who took at least 1 dose of study medication.|||participants|||Number
2747914|NCT00891995|Secondary|BMI Percentile||1 year||||percent||Inter-Quartile Range|Median
2747915|NCT00891995|Secondary|Daily Insulin Dose||1 year||||u/day/kg||Standard Deviation|Mean
2747916|NCT00891995|Secondary|CGM Measured Glucose Outcomes|Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.|1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.|||percent||Inter-Quartile Range|Median
2747917|NCT00891995|Secondary|CGM Mean Glucose||1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.|||mg/dL||Inter-Quartile Range|Median
2747918|NCT00891995|Secondary|Adverse Events (Severe Hypoglycemia)||1 year||||participants|||Number
2747919|NCT00891995|Secondary|HbA1c||1 year||||percent||Standard Deviation|Mean
2747920|NCT00891995|Secondary|Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT|Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.|0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.|||participants|||Number
2747921|NCT00891995|Secondary|Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment||0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.|||pmol/ml||95% Confidence Interval|Geometric Mean
2747922|NCT00891995|Primary|C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.|In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).|At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.|||pmol/ml||95% Confidence Interval|Geometric Mean
2747923|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
2747924|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
2747925|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
2747926|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/Baseline||||Participants|||Number
2747927|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
2747928|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
2747929|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
2747930|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||Participants|||Number
2747931|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
2747932|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
2747933|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
2747934|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||Participants|||Number
2752095|NCT00859638|Secondary|Self-efficacy for Chronic Disease Scale||4 months|||||||
2747935|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
2747936|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
2747937|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
2747938|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||Participants|||Number
2747939|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||participants|||Number
2747940|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||participants|||Number
2747941|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||participants|||Number
2747942|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||participants|||Number
2747943|NCT00891930|Secondary|Number of Subjects With Worst Post-baseline Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded using CTCAE v3.0.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2|||participants|||Number
2747944|NCT00891930|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where 1 = Mild [aware of sign or symptom, but easily tolerated]; 2 = Moderate [discomfort enough to cause interference with usual activity]; 3 = severe [incapacitating with inability to work or do usual activity]; 4 = life-threatening; 5 = fatal), with the exception of selected skin toxicities that were graded using a modified version of CTC. Treatment-related adverse events were those events for which the investigator considered there to be a reasonable possibility that the event may have been caused by panitumumab (Part 1) and by panitumumab and/or ganitumab (Part 2). Discontinuation includes AEs leading to discontinuation of panitumumab (Part 1) and panitumumab, ganitumab (Part 2) or removal from the study.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2|||participants|||Number
2747945|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Ganitumab|Two validated assays were used to detect the presence of anti-ganitumab antibodies. First, an eletrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding ganitumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against ganitumab.|From first dose of ganitumab until 30 days after last dose; median time frame was 2.4 months.|Primary Analysis Set - Part 2 particpants with at least 1 post-baseline immunoassay result.|||participants|||Number
2747946|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. Postive samples were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay.|From first dose date to 30 days since the last dose date. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 participants with at least 1 post-baseline immunoassay result.|||participants|||Number
2747947|NCT00891930|Secondary|Duration of Response|Duration of response is defined as the time from the first confirmed objective response to the earlier date of disease progression or death. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response|||months||95% Confidence Interval|Median
2747948|NCT00891930|Secondary|Time to Objective Response|Time to objective response was defined as the time from first dose of study drug to the first confirmed objective response. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the end of treatment in each Part; median duration of treatment was 16 weeks in Part 1 and 8 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response|||months||Full Range|Median
2747949|NCT00891930|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first dose of study therapy in Part 1 or Part 2 to the date of death. Participants who had not died by the analysis data cutoff date were censored at their last contact date.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1 and Part 2|||months||95% Confidence Interval|Median
2747950|NCT00891930|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval from the first dose of study therapy to the earlier date of disease progression (per modified RECIST version 1.0) or death prior to the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 2 where applicable. Participants who had not progressed or died during this period were censored at their last evaluable disease assessment date. Progressive Disease (PD): At least a 20% increase in the size of target or non-target lesions, significant increase in pleural effusions, ascites, or other fluid collections with cytologic proof of malignancy, or any new lesions.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1: participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan. Part 2: participants who had radiographically confirmed disease progression on treatment in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2.|||months||95% Confidence Interval|Median
2747951|NCT00891930|Secondary|Part 1: Objective Response Rate|"Objective response rate is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified RECIST version 1.0 criteria during the treatment period.~Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From first dose of study drug until the end of treatment in Part 1; median duration of treatment was 16 weeks.|Tumor Response Evaluable Analysis Set – Part 1 (participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with at least one Baseline uni-dimensionally measurable lesion per the RECIST version 1.0 based on investigators’ review).|||percentage of participants||95% Confidence Interval|Number
2747952|NCT00891930|Primary|Part 2: Objective Response Rate (ORR)|Objective response rate (ORR) is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression (increase in size) of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From the first dose of study drug in Part 2 until the end of treatment in Part 2; median duration of treatment in Part 2 was 8 weeks.|Tumor Response Evaluable Analysis Set - Part 2 (participants who had radiographically confirmed disease progression on panitumumab and irinotecan in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2 and with at least 1 baseline uni-dimensionally measurable lesion per the RECIST v1.0 based on investigators’ review.|||percentage of participants||95% Confidence Interval|Number
2747953|NCT00891930|Primary|Part 1: Emergence of Mutant KRAS|Mutation in Kirsten rat sarcoma-2 virus oncogene (KRAS) status was determined by examining KRAS exons 2, 3, and 4. The emergence of mutant KRAS was defined as a change in KRAS mutation status from wild-type at Baseline in KRAS exons 2, 3, and 4 to mutant in any of KRAS exons 2, 3, and 4 at the time of the second biopsy following the radiographic evidence of acquired resistance to panitumumab when given in combination with irinotecan.|From first dose of study drug until the 2nd biopsy at the time of disease progression/entry into Part 2; median duration of treatment in Part 1 was 16 weeks.|KRAS analysis set (participants with known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with known KRAS status at baseline and at acquired disease resistance to panitumumab in combination with irinotecan (i.e., based on the results of the second biopsy on study).|||percentage of participants||95% Confidence Interval|Number
2747954|NCT00891904|Secondary|Overall Survival||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter|Trial terminated early. Too few patients to analyze.||||||
2747955|NCT00891904|Secondary|Local and Distant Control||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.|Trial terminated early. Too few patients to analyze.||||||
2747956|NCT00891904|Secondary|Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients||2 years|Trial terminated early. Too few patients to analyze.||||||
2747957|NCT00891904|Primary|Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30||Daily while on Treatment|Trial terminated early. Too few patients to analyze.||||||
2747958|NCT00891878|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.|Up to 3 years|Patients who achieved an objective response to be either a CR or PR were included in this analysis.|||months||95% Confidence Interval|Median
2747959|NCT00891878|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.|Up to 3 years|All evaluable patients|||months||95% Confidence Interval|Median
2747960|NCT00891878|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.|Up to 3 years|All evaluable patients|||months||95% Confidence Interval|Median
2747961|NCT00891878|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Up to 3 years|All evaluable patients|||Months||95% Confidence Interval|Median
2752096|NCT00859638|Secondary|Health Care Utilization||4 months|||||||
2752097|NCT00859638|Secondary|Self-rated Health||4 months|||||||
2747962|NCT00891878|Secondary|Response Rate (Complete Response or Partial Response)|A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher's Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Up to 3 years|All evaluable patients|||percentage of patients||95% Confidence Interval|Number
2747963|NCT00891878|Primary|Comparison of Progression-free Survival|The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 3 years|All evaluable patients|||Months||95% Confidence Interval|Median
2747964|NCT00891839|Secondary|Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is:~Grade 0: Fully active, able to carry on all pre-disease activities without restriction;~Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;~Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;~Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;~Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.~The shift table compares baseline ECOG scores to the ECOG scores as of the last treatment visit."|Day 0 (baseline) up to Month 8|Safety population. One participant dropped out prior to obtaining a post-treatment ECOG evaluation.|||participants|||Number
2747965|NCT00891839|Secondary|Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)|Participants had a whole-body PET at baseline and at the end of cycle 6 or the end-of-treatment visit. Negative PET refers to PET results showing no abnormal lymph nodes; conversely, positive PET refers to PET results showing abnormal lymph nodes.|Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)|Safety population of participants with PET data|||participants|||Number
2747966|NCT00891839|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival is defined as the time from first exposure to study medication to death, or to last date from adverse events, concomitant medications, vital signs, lost to follow-up, or last known alive, for overall survival censoring date.|Day 1 up to Month 57|Safety population|||months||95% Confidence Interval|Median
2747967|NCT00891839|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression-free survival is defined as the time from first exposure to study medication to disease progression or relapse, or death due to any cause. Progression is defined using the 2007 International Working Group criteria, as any new lesion or increase by at least 50% of previously involved sites from nadir.|Day 1 up to Month 45|Safety population|||months||95% Confidence Interval|Median
2747968|NCT00891839|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response is defined as the time between the date of the first response to date of progression or death. Response is determined on the basis of the 2007 IWG criteria. A complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 1 up to Month 43|Safety population of participants who had a response.|||months||95% Confidence Interval|Median
2747969|NCT00891839|Primary|Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria|"The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.~95% CIs are calculated using binomial exact method."|Month 3 (end of cycle 3), Month 6 (end of cycle 6)|Safety population consisting of all participants treated with at least 1 dose of bendamustine HCL.|||percentage of participants||95% Confidence Interval|Number
2747970|NCT00891813|Secondary|Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).|The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.|24 Weeks||||Number of participants|||Number
2747971|NCT00891813|Secondary|Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL|Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.|24 Weeks||||Weeks||Inter-Quartile Range|Median
2747972|NCT00891813|Primary|The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL|The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.|24 weeks|Analysis is based on the number of participants completing the study.|||Percentage of participants|||Number
2747973|NCT00891774|Secondary|Subject's Satisfaction of the Overall Treatment||1, 3 and 6 months post injection|Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported.||||||
2747974|NCT00891774|Secondary|Investigator's Satisfaction of the Overall Treatment||1, 3 and 6 months post injection|Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported.||||||
2747975|NCT00891774|Secondary|Reduction in Wrinkle Severity Score||Baseline, 1, 3 and 6 months post injection|Sponsor made business decision to discontinue marketing of product in US and program was terminated before full analysis of results. No analysis was performed on Secondary Outcome Measures. Sincere efforts were made to obtain secondary outcome measure data; there is no longer access to these data and therefore no data can be reported.||||||
2747976|NCT00891774|Primary|Safety Endpoint|Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation|6 months post injection||||Participants|||Number
2747977|NCT00891735|Secondary|Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12|The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Disc area units||Standard Deviation|Mean
2747978|NCT00891735|Secondary|Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||mm^3||Standard Deviation|Mean
2747979|NCT00891735|Secondary|Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||µm||Standard Deviation|Mean
2747980|NCT00891735|Secondary|Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12|The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2747981|NCT00891735|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2747982|NCT00891735|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2747983|NCT00891735|Secondary|Number of Ranibizumab Injections up to But Not Including Month 12||Baseline to Month 12|All treated patients. Observed data were used with no imputation.|||Injections||Standard Deviation|Mean
2747984|NCT00891735|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Letters||Standard Deviation|Mean
2747985|NCT00891657|Primary|Area of Sites Adherent to the Uterus (cm^2)||8-12 weeks post myomectomy||||cm^2||Standard Deviation|Mean
2747986|NCT00891657|Primary|Mean Extent Score of Sites Adherent to the Uterus|0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area.|8-12 weeks post myomectomy||||Scores on a Scale||Standard Deviation|Mean
2747987|NCT00891657|Primary|Mean Severity Score of Sites Adherent to the Uterus|The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.|||Scores on a Scale||Standard Deviation|Mean
2747988|NCT00891657|Primary|Number of Sites Adherent to the Uterus|The number of times an adhesion is attached to the uterus.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.|||Adhesion Sites||Standard Deviation|Mean
2747989|NCT00891618|Primary|Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)|"Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0=not at all and 4=equals very much). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome)."|Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.|Participants were excluded from primary outcome if did not complete follow up assessments.|||units on a scale||Standard Deviation|Mean
2747990|NCT00891527|Secondary|Number of Patients With Disease Stabilization at 48 Weeks||48 weeks||||Participants|||Count of Participants
2747991|NCT00891527|Secondary|Number of Patients With Disease Progression at 48 Weeks|"Patients will be classified as having disease progression if at least 2 pulmonary veins have significantly worsened at 48 weeks. This determination is based on the study defined Pulmonary Vein Status Scale, which categorizes pulmonary veins on a scale from 1- None: No narrowing of the luminal contour, to 7- Distal atretic: Complete obliteration of the luminal contour extending >5mm within the vessel segment."|48 weeks||||Participants|||Count of Participants
2747992|NCT00891527|Primary|Number of Patients With Survival at 48 Weeks||48 weeks||||Participants|||Count of Participants
2747993|NCT00891462|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)|Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.|||L||Standard Error|Least Squares Mean
2747994|NCT00891462|Primary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.|||L||Standard Error|Least Squares Mean
2747995|NCT00891436|Secondary|Histamine Content in the Tears Was Measured.|Tear samples were assayed for histamine by ELISA|Samples taken at initial visit & 2 week follow-up|All participants had tears measured for histamine.|||ng/ml||Standard Error|Mean
2747996|NCT00891436|Primary|Eosinophilic Cationic Protein (ECP) Levels|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.|Samples taken at initial visit & 2 week follow-up|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.||||||
2747997|NCT00891371|Secondary|Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools||Day 56|ITT Population; Missing number of subjects: 1|||Percentage of participants|||Number
2747998|NCT00891371|Secondary|Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects|Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.|Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1|||Percentage of days per Week||Standard Deviation|Mean
2747999|NCT00891371|Secondary|Percent Change in Mean Number of Stools Compared to Baseline||Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1|||Percent change||Standard Deviation|Mean
2748000|NCT00891371|Secondary|Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline|Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid|Baseline (day 1), day 28 and day 56|ITT Population; Missing number of subjects = 1|||units on a scale||Full Range|Median
2748001|NCT00891371|Secondary|Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline|"SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition~IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL"|Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56|ITT Population, Analysis based on number (n) of patients with a valid value.|||units on a scale||Standard Deviation|Mean
2748002|NCT00891371|Primary|Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)||Day 28|Intention to Treat (ITT) Population [All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods]|||Percentage of patients|||Number
2748003|NCT00891319|Secondary|Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment|"The Upper Extremity Fugl-Meyer (UEFM) Assessment is a measure of upper limb motor impairment. Participants are asked to attempt to perform a list of very specific movements of the arm, elbow, forearm, wrist, and hand that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 66, minimum score of 0.~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and 6 months after completion of treatment.||||units on a scale||95% Confidence Interval|Mean
2748012|NCT00891293|Secondary|Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748004|NCT00891319|Secondary|Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment|"The Arm Motor Abilities Test assesses the participant's ability to execute specific upper limb tasks and does not allow for compensation with the unimpaired side. The test consists of 9 compound tasks composed of 1 to 3 component tasks, each of which is rated on a 0 - 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it does not participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, almost normal use of affected limb; 5, normal use. The final score is the average of all component task scores across all 9 compound tasks.~The minimum score is 0; maximum score is 5. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and 6 months after completion of treatment.||||units on a scale||95% Confidence Interval|Mean
2748005|NCT00891319|Primary|Change in Box and Block Test Score at 6 Mo Post-Treatment|"The Box and Blocks test counts how many times the participant can pick up 1 block at t time, move it over a partition, and release it in a target area within 60 seconds.~The minimum score is 0. There is no maximum score. The average score of healthy individuals within the age range of this study ranges from 70 to 79.~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and 6 months after completion of treatment.||||blocks||95% Confidence Interval|Mean
2748006|NCT00891293|Secondary|Percent Change in Non-HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748007|NCT00891293|Secondary|Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748008|NCT00891293|Secondary|Percent Change in Apo A-1 From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study|Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748009|NCT00891293|Secondary|Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)|Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748010|NCT00891293|Secondary|Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748011|NCT00891293|Secondary|Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748027|NCT00891202|Secondary|PAP: Hemoglobin Level||PAP Baseline (Day 1)|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||gram per deciliter (g/dL)||Standard Deviation|Mean
2748117|NCT00890825|Secondary|Change From Baseline in Tumour Size at 6 Week.|Percentage change from baseline in tumour size at 6 week. Values calculated as tumour sizes at 6 weeks minus value at baseline.|6 weeks after first dose of treatment|MITT|||Percentage change from baseline||80% Confidence Interval|Least Squares Mean
2748013|NCT00891293|Secondary|Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).|Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748014|NCT00891293|Primary|Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).|Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|Modified Intent-To-Treat (MITT) Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
2748015|NCT00891228|Secondary|The Impact on Sperm Morphology in Men Who Are Not Azoospermic||24 weeks|Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.|||percentage normal morphology||Standard Deviation|Mean
2748016|NCT00891228|Secondary|The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.||24 Weeks|Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.|||percentage of sperm||Standard Deviation|Mean
2748017|NCT00891228|Secondary|The Number of Men Who Have Azoospermia||24 Weeks||||participants|||Number
2748018|NCT00891228|Secondary|The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.||24 Weeks||||participants|||Number
2748019|NCT00891228|Primary|The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.||24 Weeks||||participants|||Number
2748020|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Platelet Counts at Week 234|Percent change in platelet count = ([platelet count at Week 234 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 platelet count assessment.|||percent change||Standard Deviation|Mean
2748021|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Liver Volume (in MN) at Week 234|Percent change in liver volume = ([liver volume at Week 234 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 liver volume assessment.|||percent change||Standard Deviation|Mean
2748022|NCT00891202|Secondary|LTTP: Absolute Change From Baseline in Hemoglobin Level at Week 234|Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 hemoglobin level assessment.|||g/dL||Standard Deviation|Mean
2748023|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Spleen Volume (in MN) at Week 234|Percent change in spleen volume = ([spleen volume at Week 234 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|Intent-to-treat (ITT) population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed= participants evaluable for this outcome measure and had available data for baseline and Week 234 spleen volume assessment.|||percent change||Standard Deviation|Mean
2748024|NCT00891202|Secondary|PAP: Percent Change From Baseline in Platelet Counts at Week 39|Percent change in platelet count = ([platelet count at Week 39 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||percent change||Standard Error|Least Squares Mean
2748025|NCT00891202|Secondary|PAP: Percent Change From Baseline in Liver Volume (in MN) at Week 39|Percent change in liver volume = ([liver volume at Week 39 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||percent change||Standard Error|Least Squares Mean
2748026|NCT00891202|Secondary|PAP: Absolute Change From Baseline in Hemoglobin Level at Week 39|Absolute change = hemoglobin level at Week 39 minus hemoglobin level at baseline.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||g/dL||Standard Error|Least Squares Mean
2748028|NCT00891202|Primary|PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo|Percent change in spleen volume = ([spleen volume at Week 39 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||percent change||Standard Error|Least Squares Mean
2748029|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age|Analysis was performed on the Total Enrolled cohort at 6 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.|||Subjects|||Number
2748030|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by ELISA. The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA).|At 3, 4 and 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||mIU/mL||95% Confidence Interval|Geometric Mean
2748031|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|"Cut-off values assessed were defined as equal to or above (≥) 6.2 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.~Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by Enzyme-Linked Immunosorbent Assay (ELISA). The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). Anti-HBs seroprotection was redefined as CLIA concentration above 10 mIU/mL."|At 3, 4 and 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
2748032|NCT00891176|Secondary|Anti-HBs Antibody Concentrations as Measured by ELISA|Concentrations were expressed as GMCs in mIU/mL.|At 3 and 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||mIU/mL||95% Confidence Interval|Geometric Mean
2748033|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 3 and 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age|||Subjects|||Number
2748034|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2748035|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
2748036|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
2748037|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
2748038|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age|||Titer||95% Confidence Interval|Geometric Mean
2748118|NCT00890825|Secondary|Duration of Response|Duration of response is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint.|At least 12 months after start of treatment|MITT|||Days||Standard Error|Mean
2748039|NCT00891176|Secondary|Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
2748040|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age|Analysis was performed on the Total Enrolled cohort at 4 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.|||Subjects|||Number
2748041|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||mIU/mL||95% Confidence Interval|Geometric Mean
2748042|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
2748043|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||EL.U/mL||95% Confidence Interval|Geometric Mean
2748044|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
2748045|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||μg/mL||95% Confidence Interval|Geometric Mean
2748046|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||μg/mL||95% Confidence Interval|Geometric Mean
2748047|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
2748048|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
2748049|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Titers||95% Confidence Interval|Geometric Mean
2748050|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age|Analysis was performed on the Total Enrolled cohort at 3 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.|||subjects|||Number
2748051|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||mIU/mL||95% Confidence Interval|Geometric Mean
2748052|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||subjects|||Number
2748053|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||EL.U/mL||95% Confidence Interval|Geometric Mean
2748054|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||Subjects|||Number
2748055|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|"Antibody concentrations were expressed as GMCs in μg/mL.~Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
2748056|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
2748057|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||subjects|||Number
2748058|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||Titer||95% Confidence Interval|Geometric Mean
2748059|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|The cut-off value was defined as a titer equal to or above 1:128.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||subjects|||Number
2748060|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age.|||Subjects|||Number
2748061|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
2748062|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||subjects|||Number
2748063|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study|Growth velocity parameter BMI percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.|||Percentile||Full Range|Median
2748064|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameters to Last Assessment of Study|Growth velocity parameter weight percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.|||Percentile||Full Range|Median
2748065|NCT00891046|Secondary|Percentage of Participants With Inactive Disease|Inactive disease was defined as no joints with active arthritis; no fever (body temperature ≤ 38 degree Celsius); no rheumatoid rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to SJIA; normal CRP, and a rating of no disease activity on the Physician's Global Assessment of disease activity (with a best possible score ≤10 mm on the VAS).|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.|||Percentage of participants|||Number
2748066|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study|Growth velocity parameter height percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.|||Percentile||Full Range|Median
2748067|NCT00891046|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study|Sleep patterns in children and adolescents aged between 11 and 15 years were determined using PDSS instrument to evaluate whether canakinumab helps in reducing sleepiness in children with SJIA. Participants were assessed on 8 items of PDSS, on a scale of 0 to 4 (0 - never, 1 - seldom, 2- sometimes, 3 - frequently and 4 - always). The sum of all the items was reported as total score with a range of 0-32. Change from baseline was calculated by using the formula = (post baseline value - baseline value). A positive change from baseline score indicated improvement.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, ‘Number of participants analysed’ signifies those participants with a value at both baseline and the respective post baseline time point and with an assessment of PDSS score in the given visit..|||units on a scale||Full Range|Median
2748068|NCT00891046|Secondary|Change From Baseline in EuroQual 5 -Dimension Health Status Questionnaire (EQ-5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study|"EQ-5D HRQoL tool was used for participants above 12 years and EQ-5D proxy for 8-11 years. EQ-5D index scores range from -0.11 (worst possible health, worse than dead), to 0 (dead) to 1 (perfect health). Utility based EQ-5D questionnaire provides generic measure of health for clinical and economic appraisal based on 2 parts: EQ-5D descriptive system - 5 dimensions each with 3 levels (1:no, 2:moderate, 3:severe problem) on: mobility (1=0, 2=0.069, 3=0.314), self-care (1=0, 2=0.104, 3=0.214), usual activities (1=0, 2=0.036, 3=0.094), pain/discomfort (1=0, 2=0, 3=0.386) and anxiety/depression (1=0, 2=0.071, 3=0.2). EQ-5D Total score= 1-0.081-(score of level 2 in present)-0.269 (if at least one of level 3 presents). EQ-5D total score: 1=high quality of life; -0.59 worst quality of life; and EQ-VAS - record participant's self-rated health on vertical, visual analog scale as '100=Best and 0=Worst imaginable health state'.~Positive change from baseline score indicated improved health status."|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analyzed' signifies number of participants with EQ­5D assessment in the given visit.|||units on a scale||Full Range|Median
2748069|NCT00891046|Secondary|Change From Baseline in Health-Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire- Parent Form (CHQ-PF50) to Last Assessment of Study|The Child Health Questionnaire - Parent Form (CHQ-PF50) instrument was used to measure HRQoL aged 5 to 18 years from a parent's perspective. This 14 concept questionnaire measured physical and psychosocial health of the participants on following points: physical functioning, role/social emotional, role/social behavior, role/social physical, bodily pain, general behavior, mental health, self-esteem, general health perception, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Total score ranged from 1-100. Increase in score represented improvement in overall well being of participants. Change from baseline was calculated by using the formula = (post baseline value - baseline value).|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with HRQoL assessment in the given visit.|||units on a scale||Full Range|Median
2748070|NCT00891046|Secondary|Change From Baseline in Disability, Overall Well-Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study|"The CHAQ was used to assess physical ability, overall well- being and pain intensity experienced by participants. The CHAQ (disability and well-being) dimension consisted of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other activities. Participants were graded for the response in four categories, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Participant's pain intensity was assessed by parents and adult participants (18-20 years old) on a VAS scale of 0-100 mm (0 mm: no pain to 100: very severe pain). Change from baseline was calculated by using the formula = (post baseline value - baseline value). For both scales, lower scores indicate increased functional ability."|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population.|||units on a scale||Full Range|Median
2748071|NCT00891046|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as at least 6 months of inactive disease or at least 12 months of inactive disease on medication during the extension period. Participants with inactive disease for at least 6 months, but had loss of inactive disease before 12 months were also determined.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.|||Percentage of participants|||Number
2748072|NCT00891046|Secondary|Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg|The canakinumab dose could be reduced from 4 mg/kg to 2 mg/kg in participants who were steroid-free, if requested by the treating physician and agreed by the sponsor. For treatment naive participants , dose reduction was allowed after the participant had received 6 months treatment with canakinumab.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population.|||participants|||Number
2748073|NCT00891046|Secondary|Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen|Steroid tapering with oral steroids was allowed if the participant achieved an adapted ACR Paediatric 50 response and had no fever. A participant was considered to have tapered steroids successfully, if the steroid dose was reduced from baseline and the participant did not flare and maintained a minimum adapted ACR Paediatric 30 at the last measurement. A participant was considered to have unsuccessfully tapered steroids if the steroid dose was reduced during the study but dose at last assessment was equal to or greater than dose at baseline or; if steroid dose was reduced but the participant did not maintain a minimum adapted ACR Paediatric 30 at the last measurement.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants who were steroid users at baseline.|||Percentage of participants|||Number
2748074|NCT00891046|Secondary|Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever in the preceding week (variable 7) and with no more than one variable 1 to 6 worsening by more than 30%. For minimum adapted ACR paediatric scores, the last measurement recorded from the participant's previous study was considered baseline for the current study.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit.|||Percentage of participants|||Number
2748075|NCT00891046|Secondary|Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of -CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treated: Group 2 (Completed core study)' there were no Non-Responders participants available.|||Percentage of participants|||Number
2748076|NCT00891046|Primary|Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treatment naive: Group 2' there were no participants who had discontinued other biologics due to safety/tolerability issues.|||Percentage of participants|||Number
2748077|NCT00891046|Primary|Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.|||Percentage of participants|||Number
2748086|NCT00891020|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24|"The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:~Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and~At least 3 of the following 5 assessments:~Patient's global assessment of pain-Visual Analog Scale (VAS)~Patient global assessment of disease activity-(VAS)~Physician global assessment of disease activity-(VAS)~Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)~Acute phase response C-Reactive Protein (CRP)"|Baseline, Weeks 8,16,24|Intent-to-treat population includes all participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received.|||Percentage of Participants|||Number
2748078|NCT00891046|Primary|Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 1-100 millimeter (mm) visual analog scale (VAS); 2. Participants Global Assessment on a 1-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of C-reactive protein (CRP) and 7. Absence of intermittent fever due to severe juvenile idiopathic arthritis (SJIA) during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature less than or equal to (≤) 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.|||Percentage of participants|||Number
2748079|NCT00891046|Primary|Number of Participants With Clinically Significant Local Injection Site Reactions During the Study|Local injection site tolerability was assessed on the injection site. Each participant was classified into one of the following four categories: 1. no tolerability reactions at any time during the study, 2. mild reaction observed on at least one occasion but no moderate or severe reactions. 3. moderate reaction observed on at least one occasion but no severe reaction. 4. severe reaction observed on at least one occasion.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed in SS population.|||participants|||Number
2748080|NCT00891046|Primary|Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed on the SS population.|||participants|||Number
2748081|NCT00891046|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participants or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed in safety set (SS), defined as all participants who received at least one dose of study drug.|||participants|||Number
2748082|NCT00891020|Secondary|Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24|The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Score on a scale||Standard Deviation|Mean
2748083|NCT00891020|Secondary|Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24|The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Score on a scale||Standard Deviation|Mean
2748084|NCT00891020|Secondary|Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20|Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient's benefit-risk after Week 12.|Weeks 12,16, 20|"Safety population includes participants who received at least one dose of study drug. n in each of the categories is the number of participants previously on 4mg/kg + DMARD and receiving a dose at the current visit. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period."|||Participants|||Number
2748085|NCT00891020|Secondary|Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8|Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.|Baseline, Week 8|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
2748098|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748087|NCT00891020|Secondary|Change From Baseline in DAS28 Score at Weeks 8, 16 and 24|"The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.~The Change from Baseline to Weeks 8, 16 and 24 is reported."|Baseline, Weeks 8,16,24|"Intent-to-treat includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Score on a scale||Standard Deviation|Mean
2748088|NCT00891020|Secondary|Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24|Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Weeks 8,16,24|"Intent-to-treat population includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Percentage of Participants|||Number
2748089|NCT00891020|Secondary|Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest|"Non-serious adverse Events of Special interest include:~Serious/Medically Significant Hepatic Events~Spontaneous /Serious Bleeding~Malignant Neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
2748090|NCT00891020|Secondary|Percentage of Participants Experiencing Serious Adverse Events of Special Interest|"Serious Adverse Events of Special interest include:~Serious infections including opportunistic infections~Complications of diverticulitis (including lower gastrointestinal [GI] perforations)~Myocardial infarction/acute coronary syndrome~Stroke~Spontaneous or serious bleeding~Malignant neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
2748091|NCT00891020|Primary|Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period|"An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above."|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
2748092|NCT00890981|Secondary|Actual Value of Procollagen Type 1 N-terminal Peptide|Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.|||µg/L||95% Confidence Interval|Least Squares Mean
2748093|NCT00890981|Secondary|Actual Value of Serum Type I C-telopeptide|Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.|||ng/mL||95% Confidence Interval|Least Squares Mean
2748094|NCT00890981|Secondary|Percent Change of Total Radius BMD From the Parent Study Baseline by DXA|Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748095|NCT00890981|Secondary|Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA|Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748096|NCT00890981|Secondary|Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA|Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748097|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748099|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748100|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748101|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748102|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748103|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748104|NCT00890981|Primary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
2748105|NCT00890929|Secondary|OS of Responders|OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)||||weeks||Full Range|Median
2748106|NCT00890929|Secondary|Time to PR|Responses were assessed according to the ELN guidelines.|36 weeks||||weeks||Full Range|Median
2748107|NCT00890929|Secondary|Time to CR|CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.|18 weeks||||weeks||Full Range|Median
2748108|NCT00890929|Secondary|Overall Survival (OS)|OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)||||weeks||Full Range|Median
2748109|NCT00890929|Secondary|Overall Response Rate (ORR)|ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.|26 months||||percentage of subjects|||Number
2748110|NCT00890929|Secondary|Remission Duration|Responses and remission were assessed according to the ELN guidelines.|26 months||||weeks||Full Range|Median
2748111|NCT00890929|Secondary|Maximum Tolerated Dose (MTD) of Lenalidomide|The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.|15 months|This outcome only includes results from participants in study Phase 1.|||mg/day lenalidomide (oral)|||Number
2748112|NCT00890929|Secondary|4-week Survival Rate|"Early death was assessed as death within 28 days of the start of treatment"|28 days||||percentage of subjects remaining alive|||Number
2748113|NCT00890929|Primary|Compete Remission (CR) Rate|Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.|12 months||||percentage of subjects|||Number
2748114|NCT00890916|Primary|Grasp Release Test - Test of Functional Ability to Pick up and Move Objects|Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.|6-9 weeks||||Number of Completions||Full Range|Median
2748115|NCT00890825|Secondary|Alive and Progression-Free at 6 Months|Percentage of patients alive and progression-free at 6 months|6 months after first dose of treatment|MITT|||percentage|||Number
2748116|NCT00890825|Secondary|Change From Baseline in Tumour Size at Week 12|Percentage change from baseline in tumour size at Week 12. Values calculated as tumour sizes at 12 weeks minus value at baseline.|12 weeks|MITT|||Percent change from baseline||80% Confidence Interval|Least Squares Mean
2748120|NCT00890825|Secondary|Progression Free Survival|PFS was defined as the interval between the date of randomisation and the earlier date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Patients who did not progress or die at the time of analysis were censored at the time of their latest evaluable objective tumour assessment. This also included patients who withdrew consent.|At least 12 months after start of treatment|MITT|||Participants|||Count of Participants
2748121|NCT00890825|Primary|Overall Survival|OS was calculated as the interval from the date of randomisation to the date of patient death (any cause). Patients who had not died at the time of the final analysis, or who withdrew consent, were censored at the last date the patient was known to be alive.|At least 12 months since start of treatment.|MITT|||Participants|||Count of Participants
2748122|NCT00890721|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||30 days|||||||
2748123|NCT00890721|Primary|The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.|"To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"|72 hours||||units on a scale*hr||Standard Error|Least Squares Mean
2748124|NCT00890695|Secondary|Hospital Admission or Death||from enrolment to 3 months|All participants recruited until trial halted|||participants|||Number
2748125|NCT00890695|Secondary|Anemia (Hb <9.3g/dl)||at 4 weeks|All participants recruited until trial halted|||participants|||Number
2748126|NCT00890695|Secondary|Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)||at 4 weeks and 3 months|All participants recruited until trial halted|||participants|||Number
2748127|NCT00890695|Secondary|MUAC for Age Z Score at 3 Months||between enrolment and 4 weeks and at 3 months|All participants recruited until trial halted|||Z score||95% Confidence Interval|Mean
2748128|NCT00890695|Secondary|WHZ Score at 3 Months||between enrolment and 3 months|All participants recruited until trial halted|||Z scores||95% Confidence Interval|Mean
2748129|NCT00890695|Primary|Weight for Height z Score at 4 Weeks|"The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition.~A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ<-2 and <-3 respectively. These correspond to 2 and 3 standard deviations below the reference median.~Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines."|between enrolment and 4 weeks|All participants recruited until trial was halted|||units on a scale||95% Confidence Interval|Mean
2748130|NCT00890682|Secondary|Adverse Event Profile|Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days|30 days|||||||
2748131|NCT00890682|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|"The AUC of the NRS-R pain intensity scores from time 0 through 24 hours~The subject was to rest for at least 5 minutes before responding to the following question, On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"|0-24 hours||||Units on a scale*hours||Standard Error|Geometric Mean
2748132|NCT00890656|Primary|Number of Participants With Complete Remission|Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 * 10^9/L and a platelet count of ≥ 100 * 10^9/L with complete resolution of all sites of extramedullary disease required.|Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.||||Participants|||Number
2748133|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)|Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.|4 - 9 weeks|32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy.|||Participants|||Number
2748134|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.|4 to 9 weeks|73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen.|||Participants|||Number
2748135|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks|4 to 9 weeks on combination therapy|In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen.|||Participants|||Number
2748136|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)|Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level|4 - 9 wks of olmesartan monotherapy|In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts.|||Participants|||Number
2748137|NCT00890552|Secondary|Duration of Response|Assessed as the median value for the time from first partial response until progression; death; or last follow-up.|32 months|All participants who achieved at least a partial response (9 subjects were not included due to not having any response)|||months||Full Range|Median
2748138|NCT00890552|Secondary|Event-free Survival (EFS)|Assessed as the median value for EFS 12 months after starting MDR treatment|12 months|All participants starting MDR treatment|||months||Full Range|Median
2748139|NCT00890552|Secondary|Overall Survival (OS)|Participants alive 12 months after starting MDR treatment.|12 months|All subjects receiving MDR treatment.|||percentage of participants|||Number
2748140|NCT00890552|Primary|Hematologic Response Rate|At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).|8 weeks|Subjects completing at least one full cycle of study treatment|||participants|||Number
2748141|NCT00890409|Secondary|Major Adverse Events|Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.|18 months||||participants|||Number
2748142|NCT00890409|Primary|Severe Neurodevelopmental Disability|Severe disability was defined as cerebral palsy (CP) or mental retardation (MR). The definition of MR was development quotient (DQ) <70 by Gesell's Child Development Scale and CP was based on the Criteria of a level 3 to 5 by the Gross Motor Function Classification System (GMFCS).|18 months||||participants|||Number
2748143|NCT00890409|Primary|Death|The number of deaths by 18 months of age.|18 months||||participants|||Number
2748144|NCT00890201|Secondary|Normal Preoperative Serum Values of Amylase and Lipase||24 hours|||||||
2748145|NCT00890201|Secondary|Normal Operative Cholangiography||24 hours|||||||
2748146|NCT00890201|Secondary|Amylase and Lipase Values in Gallbladders With Cholelithiasis||24 hours|||||||
2748147|NCT00890201|Secondary|Amylase and Lipase Values in Normal Gallbladders||24 hours|||||||
2748148|NCT00890201|Primary|Amylase and Lipase Values in Gallbladder Bile|Normal values of lipase and amylase in gallbladder bile should be zero|24 hours|The number of participants analyzed was determined by the number of participants that matched the inclusion criteria. As posted elsewhere some participants were excluded from this analysis based in the exclusion criteria of the protocol.|||mg/dl||Standard Deviation|Mean
2748149|NCT00890162|Primary|Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis.|To determine if treatment with omalizumab over 6 months will produce a reduction in the number and timing of anaphylactic events in subjects with a history of frequent idiopathic anaphylaxis. Ordinal outcome of participants based on number of events in 6 months after baseline and timing of first event. Events were calculated based on detailed event logs maintained by the patients and collected every 2-4 weeks based on injection schedule. Mean percent change in number of events experienced while on study agent for each subject and results presented as a group.|6 months||||percentage of change of events||95% Confidence Interval|Mean
2748150|NCT00890097|Primary|Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging|The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.|Baseline, up to Month 30|This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database.|||square millimeters per year||95% Confidence Interval|Mean
2748151|NCT00890084|Secondary|Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007|Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients|12 weeks|all investigators participating in the trial|||percentage of prescribers||95% Confidence Interval|Number
2748152|NCT00890084|Secondary|Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg||12 weeks|Intention to treat (ITT)|||percentage of patients||95% Confidence Interval|Number
2748153|NCT00890084|Secondary|Change in Concomitant Antihypertensive Drugs Given at Study Entry|Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.|baseline and 12 weeks|Intention to treat (ITT)|||percentage of patients||95% Confidence Interval|Number
2748154|NCT00890084|Secondary|Treatment Patterns|Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).|12 weeks|ITT Population|||Percentage of patients|||Number
2748155|NCT00890084|Secondary|BP Response Rate (Drop of Systolic BP of 10mmHg or More)|BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)|12 weeks|ITT Population|||Percentage of patients||95% Confidence Interval|Number
2748156|NCT00890084|Secondary|Absolute Blood Pressure Decrease|systolic blood pressure|baseline and 12 weeks|Intention to treat (ITT)|||mm Hg||95% Confidence Interval|Mean
2748157|NCT00890084|Secondary|Percentage of Patients With Blood Pressure < 130/80 mm Hg||12 weeks|Intention to Treat (ITT)|||Percentage of participants||95% Confidence Interval|Number
2748158|NCT00890084|Primary|Percentage of Patients With Blood Pressure < 140/90 mm Hg|% of high risk patients with Blood Pressure < 140/90 mm Hg|12 weeks|Intention-to-Treat (ITT)|||Percentage of participants||95% Confidence Interval|Number
2748159|NCT00889928|Primary|Procedure Completion|Completion of procedure - transvaginal removal of the gallbladder|Day of Surgery|All subjects on whom the procedure was attempted.|||participants|||Number
2748160|NCT00889915|Secondary|Clinical Global Improvements-Acceptability (CGI-A) Scale|The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability|Measured at each participant's last visit, which can occur at or before Week 6||||Units on a scale||Full Range|Median
2748161|NCT00889915|Secondary|Clinical Global Impressions-Improvement (CGI-I) Scale|The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse.|Measured at each participant's last visit, which can occur at or before Week 6||||Units on a scale||Full Range|Median
2748162|NCT00889915|Primary|Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale|The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.|Measured at each participant's last visit, which can occur at or before Week 6||||Units on a scale||Full Range|Median
2748163|NCT00889863|Secondary|Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact-emotional, Parental impact-time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.|Start Part II (Week 32), End Part II (total duration - 88 Weeks)|Full Analysis Set Part II-patients aged 5-18 years.|||Score on a scale||Standard Error|Least Squares Mean
2748164|NCT00889863|Secondary|Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact - emotional, Parental impact - time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.|Baseline, End of Part I ( Week 32)|Participants from the Full Analysis Set Part I-age 5 to 18 years.|||Score on a scale||Full Range|Median
2748165|NCT00889863|Secondary|Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI)|"CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other activities. Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do).~Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates."|Start of Part II (Week 32), End of Part II ( total duration-88 weeks)|Full Analysis set Part II.|||Score on a scale||Standard Error|Least Squares Mean
2748166|NCT00889863|Secondary|Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I|"The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other activities. Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement."|Baseline, End of Part I (Week 32)|Participants from the Full Analysis Set Part I with data at baseline and End of Part I.|||Score on a scale||Full Range|Median
2748167|NCT00889863|Secondary|Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response|"Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response.~ACR response is determined by the following items:~Physician's global assessment of disease activity~CHAQ-patient's overall wellbeing~CHAQ-Functional ability~Number of joints with active arthritis~Number of joints with limitation of motion~C-Reactive Protein.~No intermittent fever in the preceding week"|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set Part II|||Days||95% Confidence Interval|Median
2748168|NCT00889863|Secondary|Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a||Day 3|Participants from the Full Analysis Set Part I with temperature readings at Day 3.|||Percentage of participants||95% Confidence Interval|Number
2748169|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 70 and a Normal CRP.|||Days||Standard Deviation|Mean
2749185|NCT00882999|Secondary|Total Number of New or Newly Enlarging T2-Weighted MRI Lesions|Lesions were measured using T2-weighted proton density MRI scans.|Weeks 4, 8, 12, 16, 20, 24, 36, and 48|Randomized participants who had a T2-weighted MRI assessment at the specified time points.|||lesions||Standard Deviation|Mean
2748170|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP.|||Days||Standard Deviation|Mean
2748171|NCT00889863|Secondary|Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I|"Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following:~improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables~Physician's global assessment of disease activity~CHAQ-patient's overall well-being~CHAQ-Functional ability~# of joints with active arthritis~# of joints with limitation of motion~C-Reactive Protein.~no intermittent fever in the preceding week~no more than one of the first 6 response variables worsening by more than 30%"|Baseline, 32 Weeks|Participants from the full analysis set with an assessment at the given time-point.|||Percentage of participants|||Number
2748172|NCT00889863|Secondary|Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c||Start of Part Ic (After Week 8) to End of Part Ic (Week 28)|Participants from the Full Analysis set who were taking oral steroids at the start of Part Ic.|||Percentage of participants||90% Confidence Interval|Number
2748173|NCT00889863|Secondary|Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic||28 Weeks|Participants from the Full Analysis set who were taking oral steroids at the start of the study.|||Percentage of participants||95% Confidence Interval|Number
2748174|NCT00889863|Primary|Part II: Survival Estimate of Time to Flare|"Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.~Reappearance of fever (>38°C, lasting for at least 2 consecutive days) not due to infections~Flare according to the JIA pediatric criteria for flare (all criteria must have been met):~≥ 30% worsening in at least 3 of the first 6 response variables~≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II."|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set in Part II|||Days||95% Confidence Interval|Median
2748175|NCT00889863|Primary|Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid|Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures.|32 Weeks|Participants from the Full Analysis Set who were taking oral steroids at the beginning of Part I.|||Percentage of participants||90% Confidence Interval|Number
2748176|NCT00889824|Primary|Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.|The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.|6 weeks|The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations.|||units on a scale||Standard Deviation|Mean
2748177|NCT00889720|Secondary|Number of Treatment Emergent Adverse Events by Severity|Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.|||events|||Number
2748178|NCT00889720|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline|Treatment-emergent AE (TEAE): any untoward medical occurrence that occurred or worsened after beginning study treatment without regard to causal relationship. Treatment-related TEAE: investigator assessment of reasonable possibility that treatment caused or contributed to AE. Severe TEAE: interfered significantly with usual function. SAE: AE resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience (immediate risk of death), persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set: participants who took at least 1 dose (including partial doses) of study medication. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.|||participants|||Number
2748179|NCT00889720|Secondary|Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.||Baseline, Week 12, Week 26|Surgical population: Not analyzed due the limited number of participants recruited.|||percentage of participants|||Number
2748180|NCT00889720|Secondary|Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26|"Responder defined as participant who answered No to question on Nicotine Use Inventory (NUI), Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days? Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm)."|Week 26|Surgical population: N = number of participants who had a Week 26 visit.|||participants|||Number
2748181|NCT00889720|Secondary|Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)|"Responder defined as participant who answered No to question on Nicotine Use Inventory (NUI), Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days? Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm)."|Week 12|Surgical population: N = number of participants who had a Week 12 visit.|||participants|||Number
2748182|NCT00889720|Secondary|Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.||Baseline, Week 8|Surgical population. Not analyzed due the limited number of participants recruited.|||percentage of participants|||Number
2748183|NCT00889720|Secondary|Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System|Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed.|Baseline through Week 26|Surgical Population; N = participants who took at least 1 dose of study medication and received planned surgery. Results provided for participants who had a study visit at timepoint. For participants with more than 1 incidence of surgical complication recorded, the most severe incidence was used for analysis. Abbreviations: PS=post-surgery.|||participants|||Number
2748184|NCT00889720|Primary|Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.|"Responder defined as participant who answered No to question on Nicotine Use Inventory (NUI), Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days? Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm)."|7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)|Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.|||participants|||Number
2748185|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 26|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 26|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.|||participants|||Number
2748186|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 12|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 12|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.|||participants|||Number
2748187|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.|||participants|||Number
2748188|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.|||participants|||Number
2748189|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.|||participants|||Number
2748190|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.|||participants|||Number
2748191|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.|||participants|||Number
2748192|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.|||participants|||Number
2748193|NCT00889720|Primary|Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection|Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.|Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26|Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.|||participants|||Number
2748194|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.|||participants|||Number
2748195|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.|||participants|||Number
2748196|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.|||participants|||Number
2748197|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.|||participants|||Number
2748198|NCT00889720|Primary|Percentage of Fully Compliant Participants|Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.|Baseline through Week 12|Surgical Population: subset of Full Analysis Set; includes all participants who took at least 1 dose (including partial doses) of study medication and received their planned surgery within the study period. N = participants in surgical population.|||percentage of participants|||Number
2748199|NCT00889707|Secondary|Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)|A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.|3 months after treatment|The protocol-defined efficacy evaluable (EE) primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel|||ml/sec||Standard Deviation|Mean
2748200|NCT00889707|Primary|Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)|Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.|3 months post-treatment|The efficacy evaluable (EE) protocol defined primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel.|||score||Standard Deviation|Mean
2748201|NCT00889681|Primary|Long-term Clinical Success|Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|180 days|78 of 81 subjects were treated with cryoablation.|||Participants|||Number
2748202|NCT00889681|Primary|Freedom From Major Atrial Fibrillation Events (MAFE)|Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.|365 days|78 of 81 enrolled subjects were treated with cryoablation.|||Participants|||Number
2748203|NCT00889681|Primary|Acute Procedural Success (APS)|Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.|At the conclusion of the cryoablation procedure|78 of 81 subjects were treated with cryoablation.|||Participants|||Number
2748204|NCT00889681|Primary|Cryoablation Procedure Events (CPEs)|Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.|365 days|78 of the 81 enrolled subjects were treated with cryoablation.|||Participants|||Number
2748205|NCT00889603|Other Pre-specified|Number of Participants Receiving Other Medications|Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.|Baseline and Week 24|Safety population|||Participants|||Number
2748206|NCT00889603|Other Pre-specified|Number of Participants With Treatment Tolerability|Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor|Week 24|Safety population; N=number of particpants with evaluable data.|||Participants|||Number
2748207|NCT00889603|Secondary|Number of Participants in Each Patient Domain of Benefit|Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no').|Week 24|Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24.|||Participants|||Number
2748208|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS; LOCF. N=number of participants with evaluable data.|||Participants|||Number
2748209|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS. N=number of participants with evaluable data.|||Participants|||Number
2748210|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 16|FAS. N=number of participants with evaluable data.|||Participants|||Number
2748211|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS. N=number of participants with evaluable data.|||Participants|||Number
2748212|NCT00889603|Secondary|Change From Baseline in Functional Activity Questionnaire (FAQ)|Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.|Baseline and Week 24|FAS. Data not analyzed|||Scores on a scale||Standard Deviation|Mean
2748213|NCT00889603|Secondary|Change From Baseline in MMSE Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.|Baseline, Week 8, 16, and 24|FAS. N=number of participants with evaluable data.|||Scores on a scale||Standard Error|Least Squares Mean
2748214|NCT00889603|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.|Baseline and Week 24|Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.|||Scores on a scale||Standard Error|Mean
2748215|NCT00889512|Primary|The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG.||2 years||||number of follicles||Full Range|Median
2748216|NCT00889421|Secondary|Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment||7 months|||||||
2748217|NCT00889421|Primary|Reduction in Cystoid Macular Edema||6 months|||||||
2748218|NCT00889421|Primary|Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)||6 months|||||||
2748219|NCT00889421|Primary|Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%||6 months|||||||
2748220|NCT00889421|Primary|Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye||6 months|||||||
2748415|NCT00887640|Secondary|Change Over Time in CTC Gene Expression Profile|Percent change in CTC gene expression from baseline to 8 or 12 weeks of treatment.|12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.||||||
2748221|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) post-dose, pre-allergen challenge||||eyes|Participants||Number
2748222|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) pre-dose, pre-allergen challenge||||eyes|Participants||Number
2748223|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) post-dose, pre-allergen challenge||||eyes|Participants||Number
2748224|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) pre-dose, pre-allergen challenge||||eyes|Participants||Number
2748225|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 2 (Day -14) pre-allergen challenge||||eyes|Participants||Number
2748226|NCT00889330|Other Pre-specified|Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14|The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve|Visit 4 (Day 14) pre-dose, pre-allergen challenge||||eyes|Participants||Number
2748227|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 4 (Day 14) pre-dose, pre-allergen challenge||||eyes|Participants||Number
2748228|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 3 (Day 0) pre-dose, pre-allergen challenge||||eyes|Participants||Number
2748229|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14|The number of eyes with any change in visual acuity measurements compared to Day -21.|Visit 2 (Day -14) pre-allergen challenge||||eyes|Participants||Number
2748230|NCT00889330|Primary|Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 4 (Day 14) At 20 minutes following Allergen Challenge||||units on a scale||Standard Deviation|Mean
2748231|NCT00889330|Primary|Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation|"0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub"|Visit 4 (Day 14) up to 7 minutes following Allergen Challenge||||units on a scale||Standard Deviation|Mean
2748232|NCT00889330|Primary|Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment||||units on a scale||Standard Deviation|Mean
2748233|NCT00889330|Primary|Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.|"A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge||||units on a scale||Standard Deviation|Mean
2748234|NCT00889265|Secondary|Mean Wound Healing Index at 6 Months|"Score Description~Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence~Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration~Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration"|6 months||||units on a scale||Standard Deviation|Mean
2748235|NCT00889265|Primary|Change in Horizontal Ridge Widths From Baseline to 6 Months|The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.|6 months||||mm||Standard Deviation|Mean
2748236|NCT00889252|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at the 12 week visit|Subjects that completed the study per protocol were included in this analysis.|||Eyes|Participants||Number
2748237|NCT00889252|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748238|NCT00889252|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748239|NCT00889252|Primary|Intraocular Pressure - Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||mm of mercury|Participants|Standard Deviation|Mean
2748240|NCT00889252|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, the central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748241|NCT00889252|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, the upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748242|NCT00889252|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748243|NCT00889252|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748244|NCT00889252|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748245|NCT00889252|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748246|NCT00889252|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748247|NCT00889252|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748248|NCT00889252|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748249|NCT00889252|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748250|NCT00889252|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748251|NCT00889252|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748252|NCT00889252|Primary|Conjunctival Redness, Change From Baseline|Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748253|NCT00889252|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748254|NCT00889252|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2748255|NCT00889226|Secondary|The Change of LDL-C|The change of LDL-C between at 16-week and baseline|After 16wk drug administration||||mg/dl||Standard Deviation|Mean
2748256|NCT00889226|Primary|Proportion of Patients Achieving LDL- C＜100mg/dL|compare the proportion of patients achieving LDL- C＜100mg/dL|After 16wk drug administration||||Participants|||Count of Participants
2748257|NCT00889200|Primary|Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)|Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).|post drug (6 weeks oral eszopiclone)|All subjects completed all study procedures|||nmol/L|paired t-test cortisol reactivity|Standard Deviation|Mean
2748258|NCT00889187|Secondary|Surgical Mortality Rate [Phase II]|The proportion of patients with a death related to the surgery (CTCAEv3 attribution possible, probable, definite).|Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
2748330|NCT00888134|Primary|Objective Response Rate in Patients With Cancers Other Than Melanoma|Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).|4 years||||percentage of participants|||Number
2748259|NCT00889187|Secondary|Surgical Morbidity Rate [Phase II]|The proportion of patients experienced any grade 3-4 adverse event based on CTCAEv3 related to the surgery (attribution possible, probable, definite) as reported on case report forms.|Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
2748260|NCT00889187|Secondary|Progression-Free Survival (PFS) [Phase II]|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients alive whose disease had not progressed are censored at date of last disease evaluation|Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
2748261|NCT00889187|Secondary|Pathologic Response Rate [Phase II]|Pathologic response rate is the proportion of patients with the pathologic specimen absent any viable tumor cell. Pathological review of the pancreaticoduodenectomy specimen will be performed according to the AJCC Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist.|Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
2748262|NCT00889187|Secondary|Local Recurrence Rate [Phase II]|Local recurrence rate is defined as the proportion of patients with evidence of tumor recurrence within the radiation field based on RECIST criteria. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
2748263|NCT00889187|Primary|Grade 3-5 Toxicity Rate [Phase II]|All Grade 3-5 events based on CTCAEv3 related to the accelerated dose (attribution possible, probable, definite) as reported on case report forms.|within 3 weeks of the start of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
2748264|NCT00889187|Primary|Dose Limiting Toxicity (DLT) [Phase I]|DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of >7 days (d) of chemo or >3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery >3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT.|within 3 weeks of the start of chemoradiation therapy|The analysis dataset is comprised of all treated patients.|||patients with DLT|||Number
2748265|NCT00889187|Primary|Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I]|Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached.|within 3 weeks of the start of chemoradiation therapy|The analysis dataset is comprised of all treated patients.|||Gy per fraction|||Number
2748266|NCT00889005|Primary|Severity of PTSD Symptoms|Clinician Administered PTSD Scale for DSM IV (CAPS IV) Score range 0-136 points Score above 40 indicate probable PTSD PTSD diagnosis inferred using DSM IV diagnostic criteria|Up to ten months|Survivors of traumatic event with Acute PTSD symptoms one month after trauma exposure|||CAPS total Score at treatment end||95% Confidence Interval|Mean
2748267|NCT00888979|Secondary|Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.||Baseline to 4 weeks||||reduction in number of CPD||Standard Deviation|Mean
2748268|NCT00888979|Secondary|Cartridge Use||Baseline to 4 weeks||||cartridges per day||Standard Deviation|Mean
2748269|NCT00888979|Primary|Number of Days of Inhaler Use||Baseline to 4 weeks||||days||Standard Deviation|Mean
2748270|NCT00888940|Secondary|Treatment-emergent Adverse Events.||Over the duration of the study.|Safety population analyzed|||events|||Number
2748271|NCT00888940|Primary|Cumulative Volume of Packed Red Blood Cells Transfused||12 hours after the end of surgery|Modified Intent to Treat = all subjects received at least one dose and analyzed according to planned treatment assignment. 3 subjects in ecallantide group not included due to no value being present|||mL||Standard Deviation|Mean
2748272|NCT00888849|Primary|Return to Bowel Activity||Number of days post-surgery to appearance of peristaltic movement||||days||Standard Error|Mean
2748273|NCT00888849|Primary|Time of Anastomosis||Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)||||minutes||Standard Error|Mean
2748274|NCT00888849|Primary|Time of Surgery (Skin Open to Skin Close)||Day 1|Intent-to-Treat|||minutes||Standard Error|Mean
2748331|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 3.6 - 26.4 Years||Baseline and 16 weeks|Subjects who had been diagnosed with PAH for 3.6 to 26.4 years prior to Baseline.|||meters||Inter-Quartile Range|Median
2748275|NCT00888654|Secondary|Levels of Androgen Receptor in Prostate Tissue|Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue.|Pre and post radical prostatectomy|All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.|||AR score (intensity x % cells stained)||90% Confidence Interval|Mean
2748276|NCT00888654|Secondary|Serum Levels of PSA, Testosterone, and Diindolylmethane|Serum levels of PSA, testosterone, and diindolylmethane (DIM)|Pre and post radical prostatectomy|All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.|||ng/ml||Full Range|Median
2748277|NCT00888654|Primary|Mean Level of Diindolylmethane in Prostate Tissue After Treatment||Within the first 24 months after radical prostatectomy.|Patients that were eligible, evaluable, and compliant|||ng/g||90% Confidence Interval|Mean
2748278|NCT00888628|Secondary|Reduction of Insulin Requriements|Evidence of partial success will be considered for subjects who have a reduction in insulin requirements but who are not insulin independent. This will be assessed by comparing the pre-transplant insulin requirement expressed as insulin units per kg per day with the requirement preceding subsequent islet transplants and the insulin requirements at 6 months and 1, 2, and 3 years after the first and last transplant.|1 year after the subject's first islet transplant||||Participants|||Count of Participants
2748279|NCT00888628|Secondary|Number of Participants With a Decrease of Severe Hypoglycemic Events|Subjects will have a decrease in severe hypoglycemic events|1 year after subject's first transplant||||Participants|||Count of Participants
2748280|NCT00888628|Secondary|Improvement of Metabolic Control|"Whether there is an improvement in metabolic control in IAK will be evaluated based on improvement in~basal c-peptide levels,~MMTT,~insulin requirements, and~c-peptide to glucose, creatinine ratio (CPGCR)."|1 year after the subject's first islet transplant||||Participants|||Count of Participants
2748281|NCT00888628|Secondary|Absence of Negative Renal Impact Measures|Loss of allograft survivial (return to dialysis, retransplant, death) and Renal allograft function meausred by SCr|1 year after the subject's first islet transplant||||Participants|||Count of Participants
2748282|NCT00888628|Secondary|Impact on Vision|Improvement of frequency of interventions and from changes in reported visual acuity with optical refraction and severity of diabetic retinopathy|1 year after the subject's first islet transplant||||Participants|||Count of Participants
2748283|NCT00888628|Secondary|An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction||1 year after the subject's first islet transplant||||Participants|||Count of Participants
2748284|NCT00888628|Secondary|Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine|Proteinuria and serum creatinine will be stable or decreased as compared to pre-transplant values|1 year after subjects initial islet transplant||||Participants|||Count of Participants
2748285|NCT00888628|Secondary|Number of Participants With a Decrease in HbA1c|Subjects will have a decrease in HbA1c of at least >1%|1 year after subject's first islet transplant||||Participants|||Count of Participants
2748286|NCT00888628|Primary|Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.||1 year after the subject's first islet transplant||||participants|||Number
2748287|NCT00888615|Secondary|Overall Survival (Median)|Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.|From start of treatment to time of death or the date of last contact, assessed up to 5 years||||months||95% Confidence Interval|Median
2748288|NCT00888615|Secondary|Progression-free Survival (Median)|Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years||||months||95% Confidence Interval|Median
2748289|NCT00888615|Primary|The Number of Participants Who Experienced at Least One Grade 3 Adverse Event|The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.|Up to 5 years||||Participants|||Count of Participants
2748290|NCT00888615|Primary|Number of Participants Who Experienced at Least One Adverse Event|The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.|Up to 5 years||||Participants|||Count of Participants
2748291|NCT00888615|Primary|Duration of Objective Response|Duration of objective response (months)|Up to 5 years||||months||Inter-Quartile Range|Median
2748292|NCT00888615|Primary|Proportion of Participants With Objective Response|Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as assessed by MRI: Complete Response (CR), disappearance of all target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||Proportion of participants||90% Confidence Interval|Number
2748293|NCT00888459|Primary|Number of Participants With Tobacco Abstinence|self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)|12 weeks|intention to treat|||participants|||Number
2748294|NCT00888433|Primary|Office Systolic Blood Pressure Reduction|The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.|Baseline to 6 months||||mmHg||Standard Deviation|Mean
2748328|NCT00888134|Secondary|Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers|Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.|Up to 4 years||||percentage of participants|||Number
2748295|NCT00888381|Secondary|The Incidence of Any Unsolicited Adverse Events (AEs).|"The number of participants reporting any unsolicited adverse events.~Unsolicited adverse event (UAE) grading:~Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine.|||participants|||Number
2748296|NCT00888381|Secondary|The Frequency of Any Solicited Systemic Symptoms.|The number of participants reporting any solicited systemic symptoms.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.|||participants|||Number
2748297|NCT00888381|Secondary|The Frequency of Any Solicited Local Reactions.|The number of participants reporting any solicited local reactions.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.|||participants|||Number
2748298|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||percentage of participants||95% Confidence Interval|Number
2748299|NCT00888381|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||percentage of participants||95% Confidence Interval|Number
2748300|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||percentage of participants||95% Confidence Interval|Number
2748301|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to LAEs|Patients discontinued due to LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis|||Participants|||Number
2748302|NCT00888355|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2748303|NCT00888355|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2748304|NCT00888355|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2748305|NCT00888355|Other Pre-specified|Number of Patients Who Died|Patients who died during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2748306|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to CAEs|Patients discontinued due to CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2748307|NCT00888355|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2748308|NCT00888355|Other Pre-specified|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2748309|NCT00888355|Other Pre-specified|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2748329|NCT00888134|Secondary|AKT Pathway Activity|Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)|Up to 4 years|Samples and data were not collected for this outcome.||||||
2748332|NCT00887978|Post-Hoc|6-minute Walk Distance by Years Since PAH Diagnosis: 1.8 - 3.5 Years||Baseline and 16 weeks|Subjects who were diagnosed with PAH between 1.8 and 3.5 years prior to Baseline.|||meter||Inter-Quartile Range|Median
2748310|NCT00888355|Secondary|Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III.|24 hours after last morning dose and 12 hours after last PM dose at 12 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
2748311|NCT00888355|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours after last morning dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748312|NCT00888355|Secondary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748313|NCT00888355|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748314|NCT00888329|Primary|Number of Participants With Emesis|This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.|24 hours after emergence from anesthesia|ITT. However, the primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group.|||participants|||Number
2748315|NCT00888238|Secondary|Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose|Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.|||mg / kg / min||Standard Deviation|Least Squares Mean
2748316|NCT00888238|Primary|Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose|ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.|||ng/min||Standard Deviation|Least Squares Mean
2748317|NCT00888173|Other Pre-specified|Mutations in FGFR2 and PTEN|Will be correlated with PFS, overall survival (OS), tumor response, and histologic cell type.|Up to 5 years|||||||
2748318|NCT00888173|Other Pre-specified|IHC Expression of FGFR Family and Ligands, Steroid Receptor Isoforms, and pAKT|Will be correlated with PFS, OS, tumor response, and histologic cell type.|Up to 5 years|||||||
2748319|NCT00888173|Other Pre-specified|Change in Concentration of VEGF and Type IV Collagen|Will be correlated with PFS, OS, tumor response, and histologic cell type.|Baseline to up to pre-course 3|||||||
2748320|NCT00888173|Other Pre-specified|Activating Mutation in FGFR2|Will be correlated with clinical measures of outcome such as tumor response, progression-free survival (PFS), and endometrioid histology.|Up to 5 years|||||||
2748321|NCT00888173|Secondary|Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria|Adverse Events (grade 3 or higher)|Up to 5 years|Eligible and Treated Patients|||Participants|||Count of Participants
2748322|NCT00888173|Secondary|Duration of Progression-free Survival|Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on progression-free survival will be examined.|Form study entry until disease progression, death or date of last contact, assessed up to 5 years|Eligible and Treated Patients|||months||90% Confidence Interval|Median
2748323|NCT00888173|Secondary|Duration of Overall Survival|Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on overall survival will be examined.|From entry into the study to death or the date of last contact, assessed up to 5 years|Eligible and Treated Patients|||months||90% Confidence Interval|Median
2748324|NCT00888173|Primary|Tumor Response|Per response evaluation criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30 % decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|If evaluated by physical exam, response was assessed prior to each cycle. If evaluated by CT or MRI, response was assessed during course of therapy. Overall time frame is up to 6 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2748325|NCT00888173|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For patients whose disease can be evaluated by physical examination, progression was assessed prior to each cycle for 6 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2748326|NCT00888134|Secondary|Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip||Up to 4 years|Samples and data were not collected for this outcome.||||||
2748327|NCT00888134|Secondary|Progression-free Survival|Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.|4 months||||percentage of participants||95% Confidence Interval|Number
2748339|NCT00887978|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 16. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 16 Weeks|Subjects in countries where the CAMPHOR has not been validated in the local language were not included in these analyses. Additionally, only subjects with completed questionnaires at Baseline and Week 16 were analyzed.|||units on a scale||Inter-Quartile Range|Median
2748340|NCT00887978|Secondary|N-terminal proBNP (NT-proBNP)|Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.|Baseline and 16 Weeks|Subjects who were missing Week 16 samples were not included in the analysis.|||pg/mL||Standard Deviation|Mean
2748341|NCT00887978|Secondary|Dyspnea Fatigue Index|The dyspnea-fatigue index was assessed at Baseline and Week 16. Each of the three components of the dyspnea-fatigue index were rated on a scale 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.|Baseline and 16 Weeks|Subjects without a Dyspnea Fatigue Index score at Baseline were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2748342|NCT00887978|Secondary|Symptoms of PAH|Symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed by the physician at Baseline and Week 16. Severity grade values (i.e., 0, 1, 2 or 3) for each symptom were provided each subject. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Mean change in symptom severity from Baseline to Week 16 is described.|Baseline and 16 Weeks|Subjects without Baseline assessments of PAH symptoms were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2748343|NCT00887978|Secondary|World Health Organization (WHO) Functional Class|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and 16 Weeks|Subjects with a WHO functional class assessment at Week 16|||participants|||Number
2748344|NCT00887978|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and 16 Weeks|All subjects with a Baseline Borg Score were included in the analysis. One subject in the placebo group did not have a Baseline Borg Score recorded.|||score||Inter-Quartile Range|Median
2748345|NCT00887978|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 16 weeks of study:~Death (all causes excluding accident)~Transplantation~Atrial septostomy~Hospitalization as a result of right heart failure~Greater than or equal to a 20% decrease in 6MWD from Baseline (or too ill to walk) AND addition of an inhaled prostacyclin analogue, ERA, or PDE-5i~Initiation of parenteral prostacyclin therapy (i.e., epoprostenol, iloprost, or treprostinil) for the treatment of PAH"|Baseline and 16 Weeks|Intention to treat analysis|||number of clinical worsening events|||Number
2748346|NCT00887978|Primary|6-minute Walk Distance (6MWD)|"Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies)."|Baseline and 16 weeks|Intention to treat analysis|||meters||Inter-Quartile Range|Median
2748347|NCT00887965|Secondary|Procollagen Type 1 N-terminal Peptide (P1NP)|Procollagen Type 1 N-terminal Peptide is a biochemical marker of bone turnover. Blood samples were drawn for assessment of P1NP levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy|||μg/L||Inter-Quartile Range|Median
2748348|NCT00887965|Secondary|C-Telopeptide (CTX-1)|C-Telopeptide is a biochemical marker for bone turnover. Blood samples were drawn for assessment of CTX-1 levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy|||ng/mL||Inter-Quartile Range|Median
2748349|NCT00887965|Secondary|Bone Histomorphometry: Mineralization Lag Time|The mineralization lag time is the time interval between osteoid secretion and its subsequent mineralization, in days.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||days||Inter-Quartile Range|Median
2748350|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Volume|Osteoid volume is expressed as a percentage of total bone volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of total volume||Inter-Quartile Range|Median
2748351|NCT00887965|Secondary|Bone Histomorphometry: Activation Frequency|The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency (Ac.f). Activation frequency is calculated as the bone formation rate / wall width.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||/year||Inter-Quartile Range|Median
2748352|NCT00887965|Secondary|Bone Histomorphometry: Formation Period|The formation period is the duration of an interval when a place on the bone surface is actively forming bone. The formation period is calculated as the wall width (thickness of new bone made in one cycle) divided by the mineral apposition rate.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||days||Inter-Quartile Range|Median
2748353|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|Bone formation rate - volume based (BFR/BV) is the calculated rate at which cancellous bone volume is being replaced annually. BFR/BV is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percent of bone volume per year||Inter-Quartile Range|Median
2748354|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|Bone formation rate - surface based (BFR/BS) is the calculated rate at which cancellous bone surface is being replaced annually. BFR/BS is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface /total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm^3 /μm^2 /year||Inter-Quartile Range|Median
2748355|NCT00887965|Secondary|Bone Histomorphometry: Adjusted Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm/day||Inter-Quartile Range|Median
2748356|NCT00887965|Secondary|Bone Histomorphometry: Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm/day||Inter-Quartile Range|Median
2748357|NCT00887965|Secondary|Bone Histomorphometry: Total Mineralizing Surface|Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
2748358|NCT00887965|Secondary|Bone Histomorphometry: Double-label Surface|Double-label surface is expressed as a percentage of total bone surface. The presence of double labels indicates that normal bone mineralization was actively occurring over the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
2748359|NCT00887965|Secondary|Bone Histomorphometry: Single-label Surface|Single-label surface is expressed as a percentage of total bone surface. The presence of a single label indicates that mineralization was occurring during only one labeling period.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
2748360|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|Osteoclast number expressed per bone surface area. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||1/100 mm||Inter-Quartile Range|Median
2748361|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|Osteoclast number expressed per mm of bone. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||1/mm||Inter-Quartile Range|Median
2748362|NCT00887965|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|Eroded surface is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
2748363|NCT00887965|Secondary|Bone Histomorphometry: Wall Thickness|Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
2748364|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Width|Osteoid thickness (width; O.Th) is the mean thickness of osteoid seams on cancellous surfaces. O.Th is normally <12.5 µm. Increased O.Th suggests abnormal mineralization (osteomalacia).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
2748365|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Surface|Osteoid surface is expressed as a percentage total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
2748366|NCT00887965|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of osteoid surface||Inter-Quartile Range|Median
2748367|NCT00887965|Secondary|Bone Histomorphometry: Surface Density|Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||mm^2 /mm^3||Inter-Quartile Range|Median
2748368|NCT00887965|Secondary|Bone Histomorphometry: Cortical Width|Cortical width correlates with dual photon absorptiometric (DPX) measurements of bone density.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
2748369|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Thickness|Mean trabecular thickness (Tb.Th) is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Tb.Th is reduced by aging and osteoporosis.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
2748370|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Separation|Trabecular separation (Tb.Sp) is the mean distance in mm between trabeculae (measured by integrated computer graphics). Tb.Sp increases with trabecular bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
2748371|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Number|Trabecular number (Tb.N) is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Tb.N is a measure of trabecular connectivity and decreases with bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||mm^-1||Inter-Quartile Range|Median
2748466|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Week 8|ITT|||Participants|||Number
2748372|NCT00887965|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Cancellous (trabecular) bone volume (Tb.V) is the relative volume of total cancellous bone measured (TV), expressed as percentage, that is occupied by trabeculae. Cancellous bone volume was measured using Fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry|||percentage of total volume||Inter-Quartile Range|Median
2748373|NCT00887965|Primary|Number of Participants With Normal/Abnormal Bone Histology|The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.|25-34 days post-Day 1|All enrolled patients who had at least one evaluable biopsy|||Participants|||Number
2748374|NCT00887926|Secondary|Number of Participants With Feline McDonough Sarcoma (FMS)-Like Tyrosine Kinase 3 (FLT3) Response|FLT3 response to IMC-EB10 is defined as wild type, internal tandem duplications (ITD) mutations and other mutations.|Week 4 and Week 8|All randomized participants who received at least 1 dose of study drug. No tyrosine kinase responses were observed as there were no responders due to high rate of treatment failures and were not evaluable.|||participants|||Number
2748375|NCT00887926|Secondary|Number of Participants With Antileukemic Complete Response (CR) or Partial Response (PR)|Assessment of antileukemic response was based on hematologic response criteria. PR defined as >1000/microliter (µL) neutrophils and ≥100000/µL platelets in peripheral blood; a decrease of ≥50% in the pretreatment percentage of blasts to 5% to 25% in the bone marrow aspirate or a value of ≤5% blasts if Auer rods are present. Cytogenetic CR defined as normal cytogenetic findings. Molecular CR defined as negative findings for minimal residual disease by automated quantitative Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) and multidimensional flow cytometry. Morphologic CR with incomplete blood count recovery defined as ≤5% blasts (containing no Auer rods) in a bone marrow aspirate with spicules; neutrophil count < 1000/µL or platelets <100000/mL in peripheral blood or no extramedullary leukemia present.|4 weeks|All randomized participants who received at least 1 dose of study drug.No anti-leukemic responses were observed as there were no responders due to high rate of treatment failures and were not evaluable.|||participants|||Number
2748376|NCT00887926|Secondary|Number of Participants With Anti-IMC-EB10 Antibodies|A participant is considered positive for antibodies against IMC-EB10 if their blood sample exhibited a post-treatment antibody level that exceeds the positive upper cut point determined from the anti-IMC-EB10 level in healthy untreated individuals. A participant was considered to have an anti-IMC-EB10 response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1, Weeks 1 and 3 and Cycle 2, Week 1: predose (28-day cycles)|Zero participants were analyzed. The study was discontinued early due to lack of efficacy and no data was collected.||||||
2748377|NCT00887926|Secondary|Number of Participants With Adverse Events (AEs) (Safety Profile of IMC-EB10)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module|8 weeks and 30-day post-treatment follow-up|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2748378|NCT00887926|Secondary|PK: Area Under the Concentration Time Curve During the Dosing Interval (AUCtau) Where Tau is 168 Hours||Cycle 1 Week 3: predose, immediately after infusion and at 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycle)|All randomized participants with AUCtau results.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2748379|NCT00887926|Secondary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Concentration [AUC(0-last)]||Cycle 1 Week 1: predose, immediately after infusion, and at 1.5, 2, 4, 8, 24, 96 and 168 h after infusion ends (28-day cycle)|All randomized participants with AUC(0-last) results.|||micrograms * hours/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2748380|NCT00887926|Secondary|Pharmacokinetic (PK): Maximum Concentration (Cmax)||Cycle 1 Week 1: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 96, and 168 h after infusion ends, and Cycle 1 Week 3: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycles)|All randomized participants with Cmax results.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2748381|NCT00887926|Primary|Maximum Tolerate Dose (MTD) of IMC-EB10|MTD is defined as the dose preceding the dose level at which 2 participants experienced a dose limiting toxicity (DLT) during Cycle 1. DLT is defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0): (1) any Grade 3 or 4 toxicity that is clearly not attributable to leukemia [for example (e.g.) a type of end-organ failure that is infrequently encountered in acute myeloid leukemia (AML)] and is possibly, probably, or definitely attributable to IMC-EB10 in the judgment of the investigator; and (2) any Grade 3 or 4 toxicity that is clearly not attributable to a co-medication (e.g., prolonged neutropenia that is not attributable to hydroxyurea).|Cycle 1 (28-day cycle)|All participants who received at least 1 dose of study drug.|||mg/kg|||Number
2748382|NCT00887913|Primary|Improvement in Brightness|"Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up post last treatment|Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.|||Scores on a scale|Participants|Standard Deviation|Mean
2748383|NCT00887913|Primary|Improvement in Smoothness|"Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 weeks follow up post last treatment|Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin|||Scores on a scale|Participants|Standard Deviation|Mean
2750830|NCT00869947|Secondary|Preferred Walking Velocity|We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.|1 year||||m/s||Standard Deviation|Mean
2748384|NCT00887913|Primary|Improvement in Fine Lines|"Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up after last treatment|Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4|||Scores on a scale|Participants|Standard Deviation|Mean
2748385|NCT00887822|Secondary|Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time|The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|From Cycle 1 until disease progression (up to 26 months)|ITT population|||scores on scale||95% Confidence Interval|Mean
2748386|NCT00887822|Secondary|Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time|EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|From Cycle 1 until disease progression (up to 26 months)|ITT population|||scores on scale||95% Confidence Interval|Mean
2748387|NCT00887822|Secondary|Percentage of Participants With Disease Control During First-Line Therapy|Disease control was defined as stable disease(SD) for 6 weeks or longer, CR plus PR as assessed by RECIST criteria for participants with measurable disease.CR:disappearance of all TLs & normalization of tumor markers. Pathological lymph nodes must have short axis measures<10 mm. PR:at least 30% decrease in sum of measures(longest diameter for tumor lesions and short axis measure for nodes)of TLs, taking as reference baseline sum of longest diameters.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression taking as reference smallest sum of longest diameters on study. For participants without measurable disease, clinical benefit rate was defined as no clinical disease progression for >/=6 weeks. Disease progression was defined as at least 20% increase in sum of diameters of TLs compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants||95% Confidence Interval|Number
2748388|NCT00887822|Secondary|Duration of Response During First-Line Therapy|Duration of response during first-line therapy was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first-line therapy. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters. Duration of response was estimated using Kaplan Meier method. Reported data included censored observations. Participants who did not progress or die after they had had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|From randomization until disease progression or death (up to 26 months)|Measurable disease population|||months||95% Confidence Interval|Median
2748389|NCT00887822|Secondary|Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy|Best overall response during first-line therapy was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR), as assessed by the RECIST criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters.|From randomization until disease progression or death (up to 26 months)|Measurable disease population included all randomized participants who had measurable disease at baseline according to RECIST.|||percentage of participants||95% Confidence Interval|Number
2748390|NCT00887822|Secondary|Time to Progression|Time to progression was defined as the time between randomization and the first occurrence of disease progression. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Time to progression was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had not progressed at the time of study completion (including participants who had died before disease progression) or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population|||months||95% Confidence Interval|Median
2748391|NCT00887822|Secondary|Percentage of Participants With Disease Progression|Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants|||Number
2748416|NCT00887640|Secondary|Time to Second PSA Progression After Addition of Anti-androgen Therapy|Time in months from the time of anti-androgen therapy to the date of second PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to second PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. Patients progressed radiographically before 2nd PSA progression occurred.||||||
2748392|NCT00887822|Secondary|PFS During First-line Therapy|PFS during first-line therapy was defined as time between randomization and date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last intake of any study medication and only if it occurred before start of non-study antineoplastic treatment, according to RECIST. Progression of disease was defined as at least 20% increase in sum of longest diameters of target lesions compared to smallest sum of longest diameters on-study & absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who neither progressed nor died in this interval, or who were lost to follow-up were censored at date of last tumor assessment/last follow-up within this time window. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population.|||months||95% Confidence Interval|Median
2748393|NCT00887822|Secondary|Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy|Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS during first-line therapy was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last confirmed intake of any study medication and before the start of non-study antineoplastic treatment, according to RECIST.|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants|||Number
2748394|NCT00887822|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to RECIST. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population|||months||95% Confidence Interval|Median
2748395|NCT00887822|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)|Progression of disease was defined as at least 20 percent (%) increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 millimeters (mm), progression of existing non-target lesions, or presence of new lesions. PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to Response Evaluation Criteria In Solid Tumors (RECIST).|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants|||Number
2748396|NCT00887822|Primary|Overall Survival|Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months).|From randomization until death (up to 34 months)|ITT population|||months||95% Confidence Interval|Median
2748397|NCT00887822|Primary|Percentage of Participants With Event (Death)|Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.|From randomization until death (up to 34 months)|ITT population|||percentage of participants|||Number
2748398|NCT00887809|Primary|Overall Objective Response|Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|6 months||||participants|||Number
2748399|NCT00887744|Secondary|Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.||From baseline up to 12 months follow up||||Proportion of patients (%)|||Number
2748400|NCT00887744|Secondary|Mean Change in Quality of Life Score at 12 Months Compared to Baseline|The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.|From baseline up to 12 months follow up||||Scores on a scale (1-100)||Standard Deviation|Mean
2748401|NCT00887744|Secondary|Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire|"The Zurich Claudication Questionnaire - Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0.~The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months||||Percent Change||Standard Deviation|Mean
2748464|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748402|NCT00887744|Secondary|Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|"The Zurich Claudication questionnaire - Symptom Severity score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5.~The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months follow up||||Percent Change||Standard Deviation|Mean
2748403|NCT00887744|Primary|The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure|"Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed:~Day of the procedure until P+1 (where P refers to the day of the surgical procedure)~P+2 until P+7"|Starting at the surgical procedure till 7 days post-operatively||||Proportion of patients (%)|||Number
2748404|NCT00887744|Primary|Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.|From baseline up to 6 weeks follow-up|Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.|||Percent change||Standard Deviation|Mean
2748405|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)|"Scoring:~Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant."|baseline and 7 weeks||||units on a scale||Standard Deviation|Mean
2748406|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)|Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.|baseline and 7 weeks||||units on a scale||Standard Deviation|Mean
2748407|NCT00887679|Secondary|Change From Randomization to End of Treatment for Trail Making Tet (TMT)|"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.~Average =29 seconds, Deficient > 78 seconds"|baseline to 7 weeks||||seconds||Standard Deviation|Mean
2748408|NCT00887679|Secondary|Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)|"Scale for scoring:~Clinical Global Impression(CGI-S)~= Normal, no symptoms~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Most extremely ill~Clinical Global Impression(CGI-I)-improvement since treatment~very much improved~much improved~minimally improved~no change from baseline~minimally worse~much worse~very much worse"|baseline and 7 weeks|3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.|||scores on a scale||Standard Deviation|Mean
2748409|NCT00887679|Primary|Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory|"Scoring~The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:~(0) I do not feel sad.~I feel sad.~I am sad all the time and I can't snap out of it.~I am so sad or unhappy that I can't stand it.~A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[6] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|baseline and 7 weeks||||units on a scale||Standard Deviation|Mean
2748410|NCT00887679|Primary|Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.|baseline and 7 weeks|3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.|||scores on an anxiety scale||Standard Deviation|Mean
2748411|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 6 months|6 months||||units on a scale||Full Range|Median
2748412|NCT00887653|Secondary|Proportion of Patients With Plasma Viral Load Below the Limit of Detection|Assess proportion of patients with PVL below limit of detection at end of study.|6 months|One subject was prematurely discontinued from the study at week 12 due to detectable HIV-1 RNA of 57 copies/mL that was sustained at 61 copies on repeated measurement two weeks later.|||proportion of participants|||Number
2748413|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 3 months|3 months||||units on a scale||Full Range|Median
2748414|NCT00887640|Secondary|Safety and Tolerability of Temsirolimus|Total number of grade 3, 4, and 5 adverse events at least possibly related to temsirolimus therapy. Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to 4.0 for the purposes of reporting to ClinicalTrials.gov.|2 years||||Adverse Events|||Number
2751407|NCT00866047|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 3 years|Intention to treat|||months||95% Confidence Interval|Median
2748417|NCT00887640|Secondary|Time to PSA Progression|Time in months from the start of study treatment to the date of first PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. PSA responses were not observed in this study and PSA progression dates would essentially be the same as the radiographic PFS dates.||||||
2748418|NCT00887640|Secondary|Maximum Rate of Change of Prostate-Specific Antigen (PSA).|Percent change in PSA between baseline and the measurement time point where the largest change in PSA occurred. Note that a positive change (greater than 0) indicates an increase in PSA, and a negative change (less than 0) indicates a decrease.|Baseline to 7 months||||Percent change||Full Range|Median
2748419|NCT00887640|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Clinical Trial Working Group 2 (PCWG2) criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Additionally, according to PCWG2 criteria, disease progression in bone is defined as 2 or more new lesions seen on bone scan compared with the baseline scan used for trial entry. Per PCWG2 guidelines, therapy was not discontinued solely due to a rise in PSA alone.|2 years||||Months||95% Confidence Interval|Median
2748420|NCT00887640|Secondary|Percent Change in LDH|To evaluate and correlate changes in serum Lactate Dehydrogenase (LDH) with CTC count changes over time in men with Castrate Resistant Prostate Cancer (CRPC) treated with temsirolimus|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.||||||
2748421|NCT00887640|Secondary|Mean Percent of N-cadherin Expression at Baseline and 8 Weeks of Treatment.|Measures of epithelial plasticity on CTCs in response to Mammalian Target of Rapamycin (mTOR) inhibition with temsirolimus, using genomic and protein immunohistochemical methodology. N-cadherin was measured in CTCs captured using the CellSearch profile kit. The proportion of CTCs expressing N-cadherin was calculated and divided by the total number of CD45-negative, pan cytokeratin (CK) - positive, and 4',6-diamidino-2-phenylindole (DAPI+) intact cells to give a fractional expression of N-cadherin. Results are reported as a percentage.|Baseline and 8 weeks|N-cadherin expression at both baseline and 8 weeks was evaluable in 7 patients.|||Percent expression||Full Range|Median
2748422|NCT00887640|Secondary|Percent Change in CTC Count From Baseline to 12 Weeks of Treatment.|To evaluate the change in CTC counts upon the addition of an anti-androgen upon PSA progression while on temsirolimus therapy|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Outcome not available at 12 weeks. CTCs were not collected at week 12 and thus were not analyzed.||||||
2748423|NCT00887640|Primary|Change in Circulating Tumor Cell (CTC) Counts in Men With Metastatic Treatment-refractory Castration-resistant Prostate Cancer.|Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.|Baseline to 8 weeks|CTC count at both baseline and week 8 were assessable in 8 of the 11 patients as CTCs were collected at both time points in these patients. Missing CTC data for 3 of the 11 patients due to laboratory error or no CTC available at various time points.|||percent change||Inter-Quartile Range|Median
2748424|NCT00887588|Secondary|Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP)|Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||mmHg||Standard Error|Least Squares Mean
2748425|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||cm/s||Standard Error|Least Squares Mean
2748426|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||bpm||Standard Error|Least Squares Mean
2748427|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||Percent||Standard Error|Least Squares Mean
2748428|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Brachial Systolic Blood Pressure (SBP), Brachial Diastolic Blood Pressure (DBP), Central Augmentation Pressure, Central Pressure at T1-DP, Central SBP, Central DBP, Central Mean Pressure|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||mmHg||Standard Error|Least Squares Mean
2748429|NCT00887588|Secondary|Change From Baseline in Albumin/Creatinine Ratio|Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio||95% Confidence Interval|Geometric Mean
2748430|NCT00887588|Secondary|Change From Baseline in Serum Creatinine|Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||µmol/L||Standard Error|Least Squares Mean
2748431|NCT00887588|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2748432|NCT00887588|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV|The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||Percentage of participants|||Number
2748433|NCT00887588|Secondary|Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened|The clinical composite assessment is defined as follows: Improved = a) participant improved (markedly or moderately) in the global assessment of disease activity with no worsening of NYHA functional class and no major adverse cardiovascular event or b) participant improved in NYHA functional class with no worsening (markedly or moderately) in the global assessment of disease activity and no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in the global assessment of disease activity or in NYHA functional class or experienced a major adverse cardiovascular event. Unchanged = participant does not meet the definition for improved or worsened.|36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||Percentage of participants|||Number
2748434|NCT00887588|Secondary|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores|The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each domain, were included in the analysis for that domain. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||score on a scale||Standard Error|Least Squares Mean
2748435|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||m/s||Standard Error|Least Squares Mean
2748436|NCT00887588|Secondary|Change in Echocardiography Parameters: Isovolumic Relaxation Time|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ms||Standard Error|Least Squares Mean
2748437|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio||Standard Error|Least Squares Mean
2748438|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||cm/s||Standard Error|Least Squares Mean
2748720|NCT00885703|Secondary|Number of Participants With CNS IRIS|Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS)|Measured from study entry through Week 24|Arms pooled by dose in study population (see study detailed description for details).|||Participants|||Count of Participants
2748439|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ml/m^2||Standard Error|Least Squares Mean
2748440|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||g/m^2||Standard Error|Least Squares Mean
2748441|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||grams (g)||Standard Error|Least Squares Mean
2748442|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||Percent ejection fraction||Standard Error|Least Squares Mean
2748443|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ml||Standard Error|Least Squares Mean
2748444|NCT00887588|Secondary|Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||cm||Standard Error|Least Squares Mean
2748445|NCT00887588|Secondary|Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)|Evaluation of cGMP was performed by a central laboratory. Change from baseline in cGMP was presented as a ratio where the ratio was calculated as the cGMP value at 36 weeks over the cGMP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio: endpoint/baseline (nmol/L)||95% Confidence Interval|Geometric Mean
2748446|NCT00887588|Secondary|Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)|Evaluation of NT-proBNP and BNP was performed by a central laboratory. Change from baseline in NT-proBNP and in BNP was presented as a ratio where the ratio for NT-proBNP was calculated as the NT-proBNP value at 36 weeks over the NT-proBNP value at baseline, and the ratio for BNP was calculated as the BNP value at 36 weeks over the BNP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
2748447|NCT00887588|Primary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|Evaluation of NT-proBNP was performed by a central laboratory. Change from baseline in NT-proBNP was presented as a ratio where the ratio was calculated as the NT-proBNP value at 12 weeks over the NT-proBNP value at baseline. A ratio < 1 indicates improvement.|Baseline, 12 weeks|Participants from the full analysis set (FAS), who had both baseline and 12 week values, were included in the analysis. The FAS consisted of all randomized participants who had baseline and at least one post-baseline efficacy measurement during the double blind period.|||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
2748448|NCT00887575|Secondary|Overall Survival (OS)|Defined as the time between Day 1 Cycle 1 to time of death from any cause.|24 months||||probability of overall survival at 24 m||95% Confidence Interval|Number
2748449|NCT00887575|Secondary|Disease-free Survival|Defined as the time between day of surgery to first documented disease occurrence or death due to any cause.|every 4 weeks from date of surgery until treatment discontinuation or death, expected average 18 months||||months||90% Confidence Interval|Median
2748450|NCT00887575|Secondary|Overall Response Rate (ORR)|Assessed by clinical, radiologic and surgical determinations before and after neoadjuvant therapy. Measurable lesions will be defined by RECIST criteria v1.1.|Days 1, 8 and 15 of each cycle, minimum of 12 weeks|Patients who were enrolled, treated at the MTD and completed at least 3 cycles of neoadjuvant therapy|||participants|||Number
2748465|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748451|NCT00887575|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of reported incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) at the phase II dose|Days 1, 8, and 15 of each 4-week cycle up to 24 weeks during neoadjuvant treatment, and every 4 weeks during maintenance treatment|The safety analysis includes all eligible patients enrolled at the MTD, whether or not treatment was recieved (6 patients in Phase I were treated at the MTD, 39 patients were enrolled in Phase II, 3 were deemed ineligible after enrollment-thus 42 patients are included in the safety analysis, including 1 eligible patient who was not treated)|||participants|||Number
2748452|NCT00887575|Primary|Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin|Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.|at weeks 26-30|Patients treated at Dose Level I (Phase I and Phase II) who underwent surgery|||participants|||Number
2748453|NCT00887562|Secondary|Mean Change in Score on the Fatigue Severity Scale (FSS)|"To assess changes following 1 month treatment with 2 different doses of idebenone with that of placebo in fatigue as assessed by the Fatigue Severity Scale (FSS).~Scale score minimum is 9 (least fatigue) and maximum is 63 (maximum fatigue). Scores of 36 or less indicate possibility that patient may not be suffering from fatigue, while scores 36 and over suggest suffering from fatigue"|Baseline and Week 4||||units on a scale||Standard Deviation|Mean
2748454|NCT00887562|Secondary|Mean Change in Venous Lactate Concentration|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on venous lactate concentration|Up to 4 weeks from baseline||||mM/L||Standard Deviation|Mean
2748455|NCT00887562|Primary|Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on cerebral lactate concentration as measured by magnetic resonance spectroscopy (MRS)|Up to 4 weeks from baseline||||IU||Standard Deviation|Mean
2748456|NCT00887549|Secondary|Percentage of Participants Surviving at 18 Months (Overall Survival Rate)|The percentage of participants surviving at 18 months was defined as the number of treated participants who had not died prior to 18 months from the date of their first dose divided by the total number of treated participants multiplied by 100. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death (up to 24.5 months)|All enrolled participants. Nineteen participants were censored for overall survival.|||percentage of participants||95% Confidence Interval|Number
2748457|NCT00887549|Secondary|Percentage of Participants With Concordance Between Local and Central Histological Diagnosis|A centralized pathology review on all enrolled participants was performed to confirm the histological diagnosis performed at the site. Upon review of the local diagnosis obtained at the respective site, the central reviewer established whether or not there was an agreement between the local and central diagnosis. The percentage of participants with concordance was defined as the number of participants for which there was an agreement divided by the number of treated participants (concordance rate) multiplied by 100.|Baseline|All enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2748458|NCT00887549|Secondary|Percentage of Participants With Tumor Response (Tumor Response Rate)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Percentage of participants with tumor response was determined by the number of participants with PR or CR (confirmed or not) divided by the total number of treated participants multiplied by 100.|Baseline to disease progression (up to 20 months)|All enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2748459|NCT00887549|Primary|Progression Free Survival (PFS)|PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.|Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)|Population for the efficacy assessment includes all treated participants with a valid TS expression assessment. Six participants were censored for PFS.|||months||95% Confidence Interval|Median
2748460|NCT00887510|Secondary|Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril|"Comparing the change in adiponectin: rand 1 visit4-visit 3 with rand 2 visit 3-2.~This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril."|Over the course of 18 weeks||||mcg/ml||Standard Deviation|Mean
2748461|NCT00887510|Primary|Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril|Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.|OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.||||minutes*mg/dl||Standard Deviation|Mean
2748462|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748463|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748467|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Weeks 1 and 2|ITT|||Participants|||Number
2748468|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Week 8|ITT|||Participants|||Number
2748469|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Weeks 1 and 2|ITT|||Participants|||Number
2748470|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.|Week 8|ITT|||Participants|||Number
2748471|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748472|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748473|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748474|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748475|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.|Weeks 1 and 2|ITT. Data are presented for only those participants completing the questionnaire.|||Participants|||Number
2748476|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748477|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748478|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748479|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748480|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748481|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748482|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748483|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748484|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2752386|NCT00857792|Primary|Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.||3 months||||% accurately detected perfusion defects|Participants||Number
2748485|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748486|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748487|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748488|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
2748489|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
2748490|NCT00887484|Secondary|Quality of Life Questionnaire - Global Score|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
2748491|NCT00887484|Secondary|Quality of Life Questionnaire - Functional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
2748492|NCT00887484|Secondary|Quality of Life Questionnaire - Emotional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
2748493|NCT00887484|Secondary|Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
2748494|NCT00887484|Secondary|Non-inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Baseline, Weeks 5 and 8|ITT|||Acne Lesions||Standard Deviation|Mean
2748495|NCT00887484|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Baseline, Weeks 5 and 8|ITT|||Acne Lesions||Standard Deviation|Mean
2748496|NCT00887484|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Baseline, Weeks 5 and 8|ITT|||Acne Lesions||Standard Deviation|Mean
2748497|NCT00887484|Secondary|Investigators Static Global Assessment|ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Baseline, Weeks 5, 8|For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo.|||units on a scale||Standard Deviation|Mean
2748498|NCT00887484|Secondary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
2748499|NCT00887484|Secondary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
2748500|NCT00887484|Primary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT|||units on a scale||Standard Deviation|Mean
2748501|NCT00887484|Primary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense."|Weeks 1 and 2|ITT|||units on a scale||Standard Deviation|Mean
2748502|NCT00887484|Primary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT|||units on a scale||Standard Deviation|Mean
2748503|NCT00887484|Secondary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
2748504|NCT00887484|Secondary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
2748505|NCT00887484|Primary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2748506|NCT00887471|Secondary|Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5|Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study|Baseline and 4 years||||participants|||Number
2748507|NCT00887471|Primary|Median Change in Apnea-hypopnea Index (AHI)|Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point|Baseline and 4 years||||events per hour of sleep||Standard Deviation|Median
2748508|NCT00887458|Secondary|To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.|Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.|Baseline and approximately 2 years from open enrollment|One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.|||percentage||95% Confidence Interval|Number
2748509|NCT00887458|Primary|To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.|"To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. PSA progression is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later."|Up to 24 weeks|Based on how many participants were evaluable for the study primary endpoint|||percent of patients||95% Confidence Interval|Number
2748510|NCT00887354|Secondary|"Timed Up and Go Test"|"Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score."|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||seconds (sec)||Standard Error|Least Squares Mean
2748511|NCT00887354|Secondary|Visual Analog Scale (VAS)|Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||millimeter (mm)||Standard Error|Least Squares Mean
2748512|NCT00887354|Secondary|Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale|Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.|Baseline|All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.|||percentage of participants|||Number
2748513|NCT00887354|Secondary|Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire|SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).|Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||units on a scale||Standard Error|Least Squares Mean
2748514|NCT00887354|Secondary|Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb|"Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .~Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use."|Baseline, Week 26; Baseline, Week 52; Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||g/cm^2||Standard Error|Least Squares Mean
2748515|NCT00887354|Secondary|Change in Lumbar Spine Areal Bone Mineral Density|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 26; Baseline, Week 52|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||g/cm^2||Standard Error|Least Squares Mean
2748516|NCT00887354|Primary|Change in Lumbar Spine Areal Bone Mineral Density (BMD)|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||gram per square centimeter (g/cm^2)||Standard Error|Least Squares Mean
2748517|NCT00887341|Secondary|Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748518|NCT00887341|Secondary|HAQ-DI Score by Visit|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2748519|NCT00887341|Secondary|Erythrocyte Sedimentation Rate|ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.|Baseline, Weeks 2, 4, 8, 12,16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2748520|NCT00887341|Secondary|C-Reactive Protein (CRP) Levels|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
2748521|NCT00887341|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)|ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748522|NCT00887341|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)|ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748523|NCT00887341|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)|ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748524|NCT00887341|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)|ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP])|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748525|NCT00887341|Secondary|DAS28 Score by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.|Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n (number)=number of participants analyzed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2748526|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT population|||percentage of participants|||Number
2752904|NCT00856388|Primary|Day 100 TRM|Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.|First 100 days|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2748527|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <3.2 by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748528|NCT00887341|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748529|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab for Any Reason||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748530|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
2748531|NCT00887341|Primary|Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2748532|NCT00887315|Secondary|Overall PFS and CT Rate|Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines|>90 days|The study was terminated before conclusions were reached so no data was analyzed.||||||
2748533|NCT00887315|Primary|1-Year Overall Survival|Overall survival is assessed at 1 year from the date of study enrollment to date of death.|Baseline to death from any cause, 1 year|The study was terminated before conclusions were reached so no data was analyzed.||||||
2748534|NCT00887289|Secondary|Behavioural Changes During Treatment|Number of patients with occurence of behavioural changes in terms of impulse control disorders|Baseline to Visit 3|Full analysis set, no imputation technique was applied|||participants|||Number
2748535|NCT00887289|Secondary|Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3|Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.|Baseline to Visit 3|Full analysis set, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
2748536|NCT00887289|Secondary|Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3|Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.|Baseline to Visit 3|Full analysis set (FAS)|||Scores on scale||Standard Deviation|Mean
2748537|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a neurologist, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
2748538|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a general practitioner, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
2748539|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|Full analysis set, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
2748540|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748541|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748542|NCT00887250|Secondary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748543|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 12|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
2748544|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 6|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
2748545|NCT00887250|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2748546|NCT00887224|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase|WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.|||scores on a scale||Standard Error|Mean
2748547|NCT00887224|Secondary|Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index|WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
2748548|NCT00887224|Secondary|Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.|Double-blind phase Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).|||participants|||Number
2748549|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase|HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
2748550|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
2748551|NCT00887224|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
2748552|NCT00887224|Secondary|Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).|||participants|||Number
2748553|NCT00887224|Primary|Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185|Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).|Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)|All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.|||percent estimated probability|||Number
2748554|NCT00887198|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
2748555|NCT00887198|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
2748556|NCT00887198|Secondary|Maximum Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
2748557|NCT00887198|Secondary|Mean Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
2748558|NCT00887198|Secondary|Number of Participants With Treatment Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From first dose of study drug up to 30 days after the last dose of study drug|Safety analysis set included all participants in the randomized population who received any study drug.|||Participants|||Number
2748559|NCT00887198|Secondary|Time to Prostate-specific Antigen (PSA) Progression|The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.|From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2748560|NCT00887198|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point|The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2748561|NCT00887198|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2748562|NCT00887198|Secondary|Time to Opiate Use for Prostate Cancer Pain|The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first opiate use or end of study (Month 60)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2748578|NCT00886821|Other Pre-specified|Stage 2: Number of Participants With Anti-Drug Antibodies||Day 0, 29 and 50|Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.|||Participants|||Count of Participants
2748743|NCT00885482|Primary|Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis||48 weeks||||patients|||Number
2748563|NCT00887198|Primary|Radiographic Progression-free Survival (rPFS)|The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2748564|NCT00887198|Primary|Overall Survival|Overall survival is defined as the time from randomization to date of death from any cause.|From randomization (Day 1) up to end of study (Month 60)|Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2748565|NCT00887159|Secondary|PFS|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients who had baseline CTC results available for analysis.|||months||95% Confidence Interval|Median
2748566|NCT00887159|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.|||months||95% Confidence Interval|Median
2748567|NCT00887159|Secondary|Response Rate|Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.|||Proportion of patients||95% Confidence Interval|Number
2748568|NCT00887159|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.|||months||95% Confidence Interval|Median
2748569|NCT00887068|Secondary|Overall Survival (OS)||3 years||||years||Standard Deviation|Median
2748570|NCT00887068|Primary|Relapse-free Survival (RFS)|The time that a participant survives without relapse of the disease.|3 years||||years||Standard Deviation|Median
2748571|NCT00886938|Primary|Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)|Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.|0,4 weeks|Total number of participants completing the full four weeks of treatment, according to protocol.|||units on a scale||95% Confidence Interval|Mean
2748572|NCT00886899|Secondary|Total Procedural Fluoroscopy Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Fluoroscopy time was not available for two participants|||minutes||Standard Deviation|Mean
2748573|NCT00886899|Secondary|Total Procedure Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Procedure time data for two participants was not available.|||minutes||Standard Deviation|Mean
2748574|NCT00886899|Primary|30-day Major Adverse Cardiac Event (MACE) Rate|Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.|30 Days|"Includes 21 patients with early (<30 day) follow-up"|||percentage of participants||90% Confidence Interval|Number
2748575|NCT00886899|Primary|Technical Success|Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire|Intraprocedural|Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.|||percentage of CTOs|Participants|90% Confidence Interval|Number
2748576|NCT00886834|Secondary|Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)|VAS; anchors: 0 =none, 100 mm= worst imaginable|prior to insertion, immediately after insertion, and prior to clinic discharge|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.|||units on a scale||Standard Deviation|Mean
2748577|NCT00886834|Primary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)|VAS (anchors: 0 = extremely easy, 100 mm= impossible)|Immediately post IUD insertion|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.|||units on a scale||Standard Deviation|Mean
2751988|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 6|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 6|FAS (LOCF)|||participants|||Number
2748579|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Anti-Drug Antibodies||Day 0, 8, 14, 15, 21, 28 and 35|Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.|||Participants|||Count of Participants
2748580|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms|Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate <35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting >30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting >30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of >30 seconds duration; asymptomatic frequent premature ventricular complexes (=>200/24 hours); asymptomatic frequent premature atrial complexes (=>240/24 hours).|Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10|Safety population will consist of all randomized patients who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748581|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Hypoglycemia|Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level <60 mg/dL if accompanied by symptoms, blood glucose level <=50 mg/dL regardless of symptoms.|Day 1: 0 hour (pre-dose) up to 48 hours post dose|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748582|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Physical Examinations|Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748583|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Criteria for ECG findings: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >=100 msec, and >=50 percent increase when baseline <=100 msec; QT/QTc interval (corrected QT interval) >=500 msec.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748584|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Vital Signs|Criteria for vital signs: pulse rate <40 beats per minute (bpm), supine, sitting and erect pulse rate <40 bpm, supine pulse rate >120 bpm, sitting pulse rate >120 bpm, and erect pulse rate >120 bpm; systolic blood pressure: SBP <90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (>=) 30 mmHg; diastolic blood pressure: DBP <50 mmHg, change from baseline in DBP >=20 mmHg.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748585|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748586|NCT00886821|Other Pre-specified|Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7|It was assessed by 7-point glucose measurements via the glucose oxidase method.|Baseline, Day 3 and 7|Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data.|||milligram per deciliter(mg/dL)||Standard Deviation|Mean
2748587|NCT00886821|Other Pre-specified|Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7|Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.|Baseline, Day 3 and 7|Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. Here, number analyzed signifies those participants who were evaluable at specified time points.|||milligram*hour per deciliter (mg*hr)/dL||Standard Deviation|Mean
2748588|NCT00886821|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2748623|NCT00886691|Secondary|Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease|Progression-free survival and overall survival broken down by measurable disease status|Continued until disease progression was assessed or up to 5 years in follow-up.|All Intent to treat patients|||Months||95% Confidence Interval|Median
2749491|NCT00880191|Secondary|Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents|The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.|Days1 through 6||||percentage of participants|||Number
2748589|NCT00886821|Secondary|Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1|AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2748590|NCT00886821|Secondary|Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1|Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2748591|NCT00886821|Secondary|Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1|MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||hour||Full Range|Median
2748592|NCT00886821|Secondary|Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2748593|NCT00886821|Secondary|Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.|||hour||Standard Deviation|Mean
2748594|NCT00886821|Secondary|Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||hour||Standard Deviation|Mean
2748595|NCT00886821|Primary|Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22||pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2748596|NCT00886821|Primary|Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8||pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2748597|NCT00886821|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1||Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2748598|NCT00886821|Primary|Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22||pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||hour||Full Range|Median
2748599|NCT00886821|Primary|Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8||pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.|||hour||Full Range|Median
2748600|NCT00886821|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1||Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||hour||Full Range|Median
2752994|NCT00855738|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline, Month 3, Month 6|FAS; LOCF. As no participants discontinued due to lack of efficacy, the time to exit analysis was not performed.|||days||Inter-Quartile Range|Median
2748601|NCT00886821|Primary|Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1|AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1|Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol.|||nanogram*hour per milliliter (ng*hr)/mL||Geometric Coefficient of Variation|Geometric Mean
2748602|NCT00886795|Secondary|Number of Participants With Clinically Detectable Improvement|Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.|at each visit and at 3 months||||participants|||Number
2748603|NCT00886795|Primary|Number of Participants With Adverse Events|Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.|baseline, 3 month and 6 months|Participants who received all four doses.|||participants|||Number
2748604|NCT00886769|Secondary|Change in Disability Score Over Time by Use of the CHAQ|The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.|At 4 week study period|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Units on a Scale||Standard Error|Least Squares Mean
2748605|NCT00886769|Secondary|Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)|CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.|Over 4 week study period (Baseline, Day 15, Day 29)|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2748606|NCT00886769|Secondary|Percentage of Patients Who Had Body Temperature ≤ 38°C|Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.|Day 3|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Percent of participants|||Number
2748607|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ|CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2748608|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)|CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 15|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2748609|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 100|Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation|baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percent of participants|||Number
2748610|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 90|Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percent of participants|||Number
2748611|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 70|Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percent of participants|||Number
2748612|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria|Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
2748613|NCT00886769|Primary|Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria|Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
2748614|NCT00886743|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin|Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.|Postdose Day 1 to end of treatment|All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.|||hours|||Number
2748615|NCT00886743|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Oprelvekin|Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.|Postdose Day 1 to end of treatment|All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.|||picograms/mililiter|||Number
2748616|NCT00886743|Secondary|Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas|Definition of QTc is based on observed individual values rather than the average across triplicate starting from Day 1 postdose through the end of treatment.|Postdose Day 1 to end of treatment|Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.|||Participants|||Number
2748617|NCT00886743|Secondary|Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas|Based on average across triplicates for a given hourly measurement.|Postdose Day 1 to end of treatment|Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.|||Participants|||Number
2748618|NCT00886743|Primary|Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)|Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett's and Fridericia formulae are presented as secondary outcome measures.|Postdose Day 1 to end of treatment|||||||
2748619|NCT00886704|Primary|Omega-3 Index|Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.|after eight weeks of intervention||||% EPA+DHA in total red cell fatty acids||Standard Deviation|Median
2748620|NCT00886704|Secondary|Palatability|Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome|at 8 weeks|Per protocol analysis|||Number on a scale from 0 - 10||Standard Deviation|Mean
2748621|NCT00886691|Secondary|Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response|Response as evaluated by CA-125 levels.A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in blood.CA 125 is a tumor marker recommended for clinical use in the diagnosis and management of ovarian cancer. CA-125 responses were assessed with Rustin criteria. Initial values had to be 2x ULN (upper limit of normal) within 2 weeks of starting therapy to be considered evaluable.Patient were evaluated by using best overall response while receiving study therapy.|Prior to each cycle of treatment. Then follow-up every three months for 2 years , then 6 months for 3 years for 5 years follow up.|CA-125 evaluable patients|||percentage of participants||90% Confidence Interval|Number
2748622|NCT00886691|Secondary|The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment.|Complete and Partial Tumor Response by RECIST 1.0|Up to 5 years|All measurable patients treated on Everolimus plus Bevicizumab and Placebo plus Bevacizumab.|||percentage of participants responding||95% Confidence Interval|Number
2748811|NCT00885118|Secondary|Ae0-24|amount of the analyte that is eliminated in urine over the time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol||Geometric Coefficient of Variation|Geometric Mean
2748624|NCT00886691|Secondary|Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)|Number of participants with a grade of 3 or higher during the treatment period.|All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment|All Intent to treat patients.|||Participants|||Count of Participants
2748625|NCT00886691|Primary|Progression-free Survival|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Duration of time from start of treatment to time of progression, assessed up to 5 years|All intent to treat patients|||months||95% Confidence Interval|Median
2748626|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 22: minute 0 and 6|||||||
2748627|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 21: minute 0 and 6|||||||
2748628|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 2: minute 0 and 6|||||||
2748629|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 2: minute 0 and 6"|||||||
2748630|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 20: minute 0 and minute 6|||||||
2748631|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 21: minute 0 and minute 6|||||||
2748632|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 22: minute 0 and minute 6|||||||
2748633|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 2: minute 0 and minute 6|||||||
2748634|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 21: minute 0 and minute 6|||||||
2748635|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 1: minute 0 and 6|||||||
2748636|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 1: minute 0 and minute 6|||||||
2748637|NCT00886639|Secondary|Lung Function|change in lung function from baseline to 3 weeks|day 1 and 21|||||||
2748638|NCT00886639|Secondary|Diffusion Capacity|change in diffusion capacity from baseline to 3 weeks|day 1 and 21|||||||
2748639|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 1: minute 0 and 6"|||||||
2748640|NCT00886639|Primary|Oxygen Response|Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks|day 1 and day 2; day 21 and day 22|per protocol|||Meter||Standard Deviation|Mean
2748641|NCT00886626|Primary|Change in Body Mass Index (BMI)|Change in body mass index (BMI) over three months|3-month|Data from all participants who completed the trial were analyzed.|||change in kg/m^2||Standard Deviation|Mean
2748642|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)|The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen.|1-5 days post administration of each VZV skin test|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.|||Participants|||Number
2748643|NCT00886613|Primary|Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)|"Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination.~For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test."|48-72 hours after administration of skin test at 14-17 days postdose 2|Per protocol population - participants with a negative baseline VZV Skin Test (<5 mm skin reaction to both, saline and the VZV skin test reagent), and who did not have a protocol deviation that could interfere with the immune response to vaccine following two administrations of either ZOSTAVAX™, placebo, or V212|||Participants|||Number
2748644|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)|The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included.|1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.|||Participants|||Number
2748659|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction|Parent & child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).|24 treatments ~ 8-12 weeks|Those completing 24 treatments|||units on a scale||Standard Deviation|Mean
2748861|NCT00884832|Secondary|Mean Number of Days With Fecal Incontinence|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||days||Standard Error|Mean
2748645|NCT00886613|Secondary|VZV Skin Test Reactions at 48 and 72 Hours (Part A)|Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test.|48 hours and 72 hours post administration of baseline skin test|42 participants enrolled in Part A|||Participants|||Number
2748646|NCT00886613|Primary|Number of Participants With a Negative VZV Skin Test at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test.|48 hours following administration of the baseline skin test|Participants enrolled in Part A with a negative reaction for saline.|||Participants|||Number
2748647|NCT00886613|Other Pre-specified|Number of Participants With a Negative Reaction for Saline at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms. The skin reaction (erythema and induration) to saline was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline.|48 hours following administration of the baseline skin test|42 participants enrolled in Part A|||Participants|||Number
2748648|NCT00886600|Secondary|Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
2748649|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
2748650|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4||Baseline and 24-hours after morning dose at Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
2748651|NCT00886600|Primary|Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24-hour period at baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
2748652|NCT00886600|Primary|Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24 hour period at Baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
2748653|NCT00886587|Secondary|Itch Score on Day 43 - Change From Baseline|The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2748654|NCT00886587|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2748655|NCT00886587|Secondary|Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).|Baseline to Day 15|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2748656|NCT00886587|Primary|Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2748657|NCT00886483|Primary|Necessary Duration of Treatment|The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.|40 treatment sessions ~ 13-20 weeks|Number of participants in active (n=24) and sham (n=10) neurofeedback completing 40 treatments.|||units on a scale||Standard Deviation|Mean
2748658|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice|Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.|24 treatments ~ 8-12 weeks|participants completing treatment 24|||percentage of participants|||Number
2748660|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.|Post-treatment at session 40|Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.|||percentage of participants|||Number
2748661|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #2. Retention|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).|40th treatment sessions ~ 13-20 weeks|Number randomized was denominator for percentage of participants completing 40 treatment sessions.|||percentage of participants|||Number
2748662|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number|The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.|2 years|Based on inclusion & exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.|||participants|||Number
2748663|NCT00886340|Secondary|Quality of Life||6 months|||||||
2748664|NCT00886340|Secondary|Lipids||6 months|||||||
2748665|NCT00886340|Secondary|Diet and Exercise Behavior||6 months|||||||
2748666|NCT00886340|Primary|Number of Participants Who Met Weight Loss Goal of 5% Weight Loss||6 months||||participants|||Number
2748667|NCT00886288|Secondary|Percentage of Patients With Positive to Negative Shift in Albuminuria|Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks|Approximately 12 weeks (10 to 14 weeks) after baseline|All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.|||Percentage of patients||95% Confidence Interval|Number
2748668|NCT00886288|Secondary|Percentage of Patients Presenting an Adverse Event (AE)|Percentage of patients with any adverse events during the study period, related or not to investigational drug|baseline to the end of study period|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||percentage of patients|||Number
2748669|NCT00886288|Secondary|Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)|The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||Percentage of patients|||Number
2748670|NCT00886288|Secondary|Mean Difference in Diastolic Blood Pressure|The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||mmHg||Standard Deviation|Mean
2748671|NCT00886288|Secondary|Mean Difference in Systolic Blood Pressure|The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||mmHg||Standard Deviation|Mean
2748672|NCT00886288|Primary|Percentage of Patients With Controlled Blood Pressure|"Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has:~no chronic renal insufficiency or macroalbuminuria-dipsticks negative,~albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine~no diabetes~or SBP < 130 mmHg and DBP < 80 mmHg if the patient has:~chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine~diabetes (type 1 or 2)"|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||Percentage of patients|||Number
2748673|NCT00886262|Secondary|Count of Patient Who Need Vasopressers in the Perioperative Period||48 hours||||Participants|||Count of Participants
2748674|NCT00886262|Secondary|Count of Participants Who Needed Diuretics Postoperatively||48 hours||||Participants|||Count of Participants
2748675|NCT00886262|Primary|Change in Urine Output||24 hours to 48 hours postop||||mL||Full Range|Mean
2748676|NCT00886262|Primary|Change in Creatinine Levels||baseline to 48 hours postop||||MG/DL||Full Range|Mean
2748677|NCT00886236|Secondary|Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data||48 hours||||% oxygen saturation||Full Range|Mean
2748678|NCT00886236|Primary|Number of Participants Who Experience Incidence of Postoperative Nausea.||120 hours||||Participants|||Count of Participants
2748679|NCT00886236|Primary|Evaluate the Amount of Diluadid Given Postoperatively|The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms.|120 hours||||ml||Full Range|Mean
2748680|NCT00886145|Primary|Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months|Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography|The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy||||Percent Change|||Number
2748681|NCT00886119|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.|||logMAR||Standard Deviation|Mean
2748706|NCT00885755|Secondary|Part I: PFS in ITT Population|PFS was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]).. In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
2748682|NCT00886015|Secondary|Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis|"Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows:~Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10 Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated, regardless of eyelashes touching globe"|2 Years|Of the 1669 TT eyelids and 1674 BLTR eyelids included in the initial analysis, 13 eyes (4 in the TT clamp group, 9 in the BLTR group) without TT at 1 year underwent operation between years 1 and 2. They are not included in the data for severity of recurrence because we do not know the TT severity.|||eyelids|eyelids||Number
2748683|NCT00886015|Secondary|Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality|"Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows:~Mild: Vertical deviation from the natural contour < 1 mm in height (less than half the pupil height in daylight) and affecting < 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour > 2 mm in height (more than the pupil height in daylight) or a defect > 2/3 of the horizontal eyelid length"|2 years|Of the 1771 participants originally assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
2748684|NCT00886015|Primary|Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities|"Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows:~Mild: Vertical deviation from the natural contour < 1 mm in height (less than half the pupil height in daylight) and affecting < 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour > 2 mm in height (more than the pupil height in daylight) or a defect > 2/3 of the horizontal eyelid length"|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
2748685|NCT00886015|Primary|Number of Eyelids Experiencing an Unfavorable Outcome|At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
2748686|NCT00886015|Primary|Number of Eyelids With Pyogenic Granuloma|A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
2748687|NCT00886015|Primary|Number of Eyelids With Presence of Recurrent Trichiasis|Trichiasis: 1 or more eyelashes touching globe in primary position|2 years|Of the 1671 eyes initially assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up.|||eyelids|eyelids||Number
2748688|NCT00885846|Primary|Fasting Blood Glucose||Week 0 (baseline) and week 12 (final)|Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.|||mg/dL||Standard Deviation|Mean
2748689|NCT00885846|Secondary|Fasting Cortisol||Weeks 0 and 12|||||||
2748690|NCT00885846|Secondary|HOMA-IR Index||weeks 0 and 12|||||||
2748691|NCT00885846|Secondary|Beck's Depression Inventory (BDI)||weeks 0 and 12|||||||
2748692|NCT00885846|Secondary|Perceived Stress Scale (PSS)||weeks 0 and 12|||||||
2748693|NCT00885846|Secondary|Fasting Insulin||weeks 0 and 12|||||||
2748694|NCT00885846|Secondary|Fasting C-peptide||weeks 0 and 12|||||||
2748695|NCT00885768|Primary|The Number of Patients With Renal Artery Stenosis|the prevalence of renal artery stenosis in patients with coronary artery disease|3months||||participants|||Number
2748696|NCT00885768|Primary|Prevalence of Renal Artery Stenosis (RAS)||2 months|||||||
2748697|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.|||percentage of participants|||Number
2748707|NCT00885755|Primary|Part I: Time to Progression (TTP) by Biomarker|Progression was defined as an increase by at least 20% from the smallest value in the SLD of lesions.TTP was determined as the time in months from the date of screening until first progression.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT . The correlation between the biomarker variables and TTP were investigated using a univariate Cox regression model and time-to-event methods (Kaplan-Meier).|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
2748698|NCT00885755|Primary|Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm.PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (<median/≥median) , PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.|||percentage of participants|||Number
2748699|NCT00885755|Primary|Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker|BOR was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST). CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (median/≥median), PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.|||percentage of participants|||Number
2748700|NCT00885755|Primary|Part II: TTP by Biomarker|TTP was calculated from first study medication in Part II to date of progression. The relationship between TTP and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT .|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
2748701|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.|||percentage of participants|||Number
2748702|NCT00885755|Secondary|Overall Survival in ITT Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|ITT population|||months||Full Range|Median
2748703|NCT00885755|Secondary|Overall Survival in Per Protocol Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|PP population|||months||Full Range|Median
2748704|NCT00885755|Secondary|Part II: PFS in ITT Population|PFS was calculated from first study medication in Part II to date of progression or death. In participants with measurable disease progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
2748705|NCT00885755|Secondary|Part II: TTP in Intent to Treat (ITT) Population|TTP was calculated from first study medication in Part II to date of progression. In participants with measurable disease progression was defined according to RECIST(SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
2748719|NCT00885703|Secondary|Number of Participants With Grade 3 and 4 Adverse Events|"Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29)~Occurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76)~See DAIDS AE Grading table V1.0"|Measured from study entry through Week 24|Arms pooled by dose in safety population (see study detailed description for details).|||Participants|||Count of Participants
2748708|NCT00885755|Primary|Part II: Progression Free Survival (PFS) by Biomarker|PFS was calculated from first study medication in Part II to date of progression or death.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95HER2 +ve and -ve population, IGF1R <median and ≥ median membrane H score, c-MET <median and ≥median membrane H score, PTEN <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
2748709|NCT00885755|Secondary|Part I: TTP in Intent to Treat (ITT) Population|TTP was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
2748710|NCT00885755|Primary|Part I: Progression Free Survival (PFS) by Biomarker|Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to (≥) median membrane H score, c-MET <median and ≥median membrane H score, phosphatase and tensin homolog gene (PTEN) <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subunit wild type (WT) and mutation (M), and FC gamma receptors IIIa homozygous Phenyl alanine (FF), heterozygous Phenyl alanine/Valine (VF) and homozygous Valine (VV), receptor IIa Phenotypes homozygous Histidine (HH), heterozygous Histidine/Arginine (HR) and homozygous Arginine (RR) IIb phenotypes homozygous Isoleucien (II),heterozygous Isoleucine/Threonine (IT) and homozygous Threonine (TT) .|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|Per Protocol (PP) population included all participants who had received a complete first dose of study medication and had baseline and at least one on-treatment biomarker assessment. Number (n) equals (=) number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
2748711|NCT00885742|Secondary|Achievement of Trough Factor XIII Levels of 5% or Higher.|Number of subjects with Factor XIII level ≥ 5% before infusion at Week 12, Week 24, Week 36 and Week 48.|At 12, 24, 36 and 48 weeks: immediately before infusion.|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.|||participants|||Number
2748712|NCT00885742|Secondary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of (U/kg) infusion.|At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Units/mL/Units/kg||Standard Deviation|Mean
2748713|NCT00885742|Secondary|Time to Peak Concentration||At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Hour||Standard Deviation|Mean
2748714|NCT00885742|Secondary|Trough FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: immediately before infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Units/mL||Standard Deviation|Mean
2748715|NCT00885742|Secondary|Peak FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Units/mL||Standard Deviation|Mean
2748716|NCT00885742|Secondary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment related AEs are defined as AEs whose relationship to study treatment is related, or possibly related, and AEs with missing relationship.|12 months|The Safety Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study.|||participants|||Number
2748717|NCT00885742|Secondary|Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels|P-value determined from Generalized Estimating Equation (GEE) model parameter estimates with bleeding as the response variable and FXIII activity trough level as the explanatory variable.|12 months|The analysis population comprised those subjects with spontaneous bleeding events requiring treatment with a FXIII-containing product. Note: no subjects had spontaneous bleeding events requiring treatment with a FXIII-containing product, so no subjects were analyzed.|||participants|||Number
2748718|NCT00885742|Primary|The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII‑Containing Product to Treat the Bleeding Event)|The number of subjects requiring treatment with a Factor XIII-containing product to treat a spontaneous bleeding event.|Up to week 52|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.|||participants|||Number
2748721|NCT00885703|Secondary|Number of Participants With Progression of Symptoms|"Progression of symptoms is defined as:~Died (including early deaths)~Discontinued Fluconazole and started ampho B~Had a positive cryptococcal culture at week 10~Microbiological Failure (i.e., relapse of CM)~Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis)~CM IRIS causing increased inflammation after ART exposure~New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma)~Possibly related to CM but mechanism indeterminate~Other defined complication unrelated to CM"|Measured from study entry through Week 24|Arms pooled by dose. Analysis done in efficacy population (see detailed study description for details).|||Participants|||Count of Participants
2748722|NCT00885703|Secondary|Number of Hospital Admissions|Count of number of times a participant was admitted to the hospital.|Measured from study entry through Week 24|Arms pooled by dose in safety population (see study detailed description for details).|||Participants|||Count of Participants
2748723|NCT00885703|Secondary|Length of Hospitalization|Duration of first hospitalization in days starting at entry in safety population.|Measured from study entry through Week 10|Arms pooled by dose in safety population (see study detailed description for details). Fluconazole 2000mg arm had one participant data missing (was not admitted to hospital at study entry).|||Days||Inter-Quartile Range|Median
2748724|NCT00885703|Secondary|Results of Functional Status Evaluation|"Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work.~The measure from 6 week before enrollment will be referred to as 'baseline'."|Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24|Arms pooled by dose. Safety population (see study detailed description for details).|||Participants|||Count of Participants
2748725|NCT00885703|Secondary|Results of the Neurological Examination|Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment).|Measured at study entry, Week 2, and Week 10|Arms pooled by dose. Safety population (see study detailed description for details).|||Participants|||Count of Participants
2748726|NCT00885703|Primary|Kaplan Meier (KM) Proportion of Participant Mortality|Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals.|Measured from study entry through Week 24|Arms pooled by dose in the safety population (see study detailed description for details).|||proportion of participants||90% Confidence Interval|Number
2748727|NCT00885703|Primary|Change in Log10 Quantitative CSF Culture Results|"Change in quantitative CSF (cerebrospinal fluid) cultures.~Note: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis."|Entry and Week 2|Arms pooled by dose. Analysis done in efficacy population (see study detailed description for details). Excludes participants who did not have a week 2 observation.|||Log10 CFU/mL||Inter-Quartile Range|Median
2748728|NCT00885703|Primary|Categorized Quantitative Culture Results|Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth.|At entry, Week 2, and Week 10|Arms pooled by dose. Analysis in efficacy population (see study detailed description for details).|||Participants|||Count of Participants
2748729|NCT00885703|Primary|Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B|"Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2~Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc."|Measured from study entry through Week10|Analysis in safety population (see study detailed description for details)|||Participants|||Count of Participants
2748730|NCT00885677|Primary|Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event|Time to first event|2 years after randomization|All subjects in analysis were included in the primary endpoint analysis|||participants|||Number
2748731|NCT00885677|Primary|Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.|The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group|1 year since the randomization|Phase 1: A total of 154 patients were enrolled from May 2009 through April 2010 from 32 centers in 6 different countries (France, Hungary, Israel, Italy, Spain, and Switzerland). The final patient cohort object of analysis comprised 148 patients (76 in the Remote group and 72 in the Control group)|||days||Inter-Quartile Range|Median
2748732|NCT00885638|Secondary|Insulin Secretion After Ingestion of Meal|Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion|300 min|Completer population|||mol/l/min||Standard Error|Mean
2748733|NCT00885638|Primary|Glucagon-like Peptide-1 Secretion After Meal Ingestion|Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion|300 min|Completer population|||nmol/l/min||Standard Error|Mean
2748734|NCT00885534|Primary|Overall Response to CVT Chemotherapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||participants|||Number
2748735|NCT00885482|Secondary|Change of Bone Density and of Subcutaneous Fat at 48 Weeks||48 weeks|||||||
2748736|NCT00885482|Secondary|Change of the Results of Neurocognitive Tests at 48 Weeks||48 weeks|||||||
2748737|NCT00885482|Secondary|Change of Metabolic Parameters at 48 Weeks||48 weeks|||||||
2748738|NCT00885482|Secondary|Evolution of Atazanavir Plasma Concentrations During the 48 Weeks||48 weeks|||||||
2748739|NCT00885482|Secondary|Evolution of Adherence and Quality of Life During the 48 Weeks||48 weeks|||||||
2748740|NCT00885482|Secondary|Evolution of CD4 Cell Count During the 48 Weeks||48 weeks|||||||
2748741|NCT00885482|Secondary|Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis||48 weeks|||||||
2748742|NCT00885482|Secondary|Time to Virological Failure at Survival Analysis||48 weeks|||||||
2748744|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria|Marked abnormality criteria were urine protein: if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine blood: if pre-Rx=0, use >=2, if pre-Rx=0.5 or 1, use >=3, if pre-Rx=2, use >=4; Urine red blood cell count (RBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine white blood cell count (WBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4.|Baseline, Week 12|All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.|||Participants|||Number
2748745|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. ULN=upper limit of normal; LLN=lower limit of normal.|Baseline, Week 12|All treated participants.|||Participants|||Number
2748746|NCT00885378|Primary|Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with both a baseline value and post-baseline value (up to Week 12).|||Percentage of glycosylated hemoglobins||Standard Error|Mean
2748747|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Heart Rate (HR)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.|||mm Hg||Standard Error|Mean
2748748|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.|||mm Hg||Standard Error|Mean
2748749|NCT00885378|Other Pre-specified|Participant Electrocardiogram (ECG) Status at Baseline and Week 12|Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.|Baseline, Week 12|All treated participants, excluding those with missing values.|||Participants|||Number
2748750|NCT00885378|Other Pre-specified|Participants With Confirmed Hypoglycemia|Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL with associated hypoglycemia symptoms.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.|||Participants|||Number
2748751|NCT00885378|Other Pre-specified|Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.|||Participants|||Number
2748752|NCT00885378|Other Pre-specified|Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment.SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.|||Participants|||Number
2748753|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.|||Percentage of Participants||95% Confidence Interval|Number
2748754|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.|||Percentage of Participants||95% Confidence Interval|Number
2748755|NCT00885378|Secondary|Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).|||mg / dL||Standard Error|Mean
2748756|NCT00885365|Secondary|Participants With a Hearing Threshold >20 Decibel in at Least One Ear|The potential ototoxic effects (hearing loss) of tobramycin were investigated by performing audiometric tests. Participants with a loss of auditory acuity greater than the 20 decibels auditory threshold are reported.|Day -10 to -1 (screening), Weeks 4 and 8|Safety population|||percentage of participants|||Number
2748767|NCT00885365|Secondary|Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FVC values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.|||percentage predicted FVC||Standard Deviation|Mean
2748757|NCT00885365|Secondary|Count of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-Emergent Adverse Events defined as adverse events occurring after the first intake of study treatment (or the same day).~The investigator assessed relation to study treatment as a binary question: Reasonable possibility of relatedness or no reasonable possibility of relatedness. The expression reasonable possibility of relatedness is meant to convey in general that there are facts (evidence) or arguments meant to suggest a causal relationship.~A serious AE results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or an important medical event.~The investigator rates the severity of the AE based on a three point scale: mild, moderate or severe. A severe event prevents any usual routine activity of the participant and causes severe discomfort."|Day 0 to Week 8|Safety population: all randomised patients who took at least one dose of study medication|||percentage of participants|||Number
2748758|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)||Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.|||kilograms/meters^2||Standard Deviation|Mean
2748759|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight|Body weight was measured at all study visits as part of the physical examination.|Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.|||kilograms||Standard Deviation|Mean
2748760|NCT00885365|Secondary|Microbiological Outcome Summary by Visit|"Microbiological outcomes are derived considering all P. aeruginosa (PA) morphotypes together.~Week 4 and Week 8 microbiological outcomes:~Eradication = elimination of PA~Persistence = persistence of PA detected at previous visit~Superinfection = appearance of a pathogen (other than PA) not detected at previous visit~Re-infection (week 8 only) = re-appearance of PA detected at Screening and eradicated at Week 4~Superinfection supersedes eradication. Persistence for P. aeruginosa supersedes superinfection.~Re-infection for P. aeruginosa supersedes superinfection."|Day -10 to -1 (screening), Weeks 4 and 8|Intent-to-Treat Population.|||percentage of participants|||Number
2748761|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa|"MIC90 is the concentration of tobramycin required to inhibit 90% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:~Morphotype 1: mucoid~Morphotype 2: dry~Morphotype 3: variant~Overall MIC90 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population|||micrograms/milliliters|||Number
2748762|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa|"MIC50 is the concentration of tobramycin required to inhibit 50% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:~Morphotype 1: mucoid~Morphotype 2: dry~Morphotype 3: variant~Overall MIC50 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population|||micrograms/milliliters|||Number
2748763|NCT00885365|Secondary|Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum|If a participant had more than one Pseudomonas aeruginosa (PA) morphotype at a given visit, and therefore more than one bacterial load value, then the bacterial load value corresponding to the highest tobramycin minimal inhibitory concentration (MIC) value regardless of the PA morphotype was used. If the tobramycin MIC value was the same for different PA morphotypes, then the bacterial load value corresponding to morphotype 1 (mucoid colony) was used. If morphotype 1 was not available, bacterial load value corresponding to morphotype 2 (dry colony) was used.|Day -10 to -1 (baseline), Week 4, Week 8|Intent-to-Treat (ITT) Population; At Week 4, six Bramitob patients and seven TOBI patients were missing sputum samples. At Week 8, 11 Bramitob patients and 16 TOBI patients were missing sputum samples.|||colony forming units/gram||Standard Deviation|Mean
2748764|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)|Difference in the forced expiratory flow rate in mid-exhalation measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.|||liters/second||Standard Deviation|Mean
2748765|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated). Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEF 25-75% values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.|||percentage predicted FEF 25-75%||Standard Deviation|Mean
2748766|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.|||liters||Standard Deviation|Mean
2748768|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.|||liters||Standard Deviation|Mean
2748769|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.|||percentage predicted FEV1||Standard Deviation|Mean
2748770|NCT00885365|Primary|Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.|Day 0 (baseline), Week 4|Intent-to-Treat (ITT) Population, Last Observation Carried Forward (LOCF)|||percentage predicted FEV1||Standard Deviation|Mean
2748771|NCT00885352|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
2748772|NCT00885352|Secondary|Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
2748773|NCT00885352|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2748774|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24|The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had 25(OH)D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748775|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24|1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had 1,25(OH)2 D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748776|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24|Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had SPH data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748777|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24|Serum phosphate is an index of mineral homeostasis.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had serum phosphate data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748778|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24|Serum calcium is an index of calcium homeostasis.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had serum calcium data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748779|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12|s-P1NP is a biochemical marker of bone formation.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2755721|NCT00836875|Secondary|Attributable Mortality - Number of Participant Deaths|Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).|Weeks 6 and EOT (up to Week 12)|Safety population|||participants|||Number
2748780|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24|Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748781|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12|BSAP is a biochemical marker of bone formation.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748782|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24|Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748783|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12|u-NTx/Cr is a biochemical marker of bone resorption.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748784|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748785|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed s-CTx at Month 12|s-CTx is a biochemical marker of bone resorption.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748786|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24|s-CTx is a biochemical marker of bone resorption.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
2748787|NCT00885170|Secondary|Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12|BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748788|NCT00885170|Secondary|Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24|BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748789|NCT00885170|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748790|NCT00885170|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24|BMD at the lumbar spine was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748791|NCT00885170|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12|BMD at the total hip was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748792|NCT00885170|Secondary|Percent Change From Baseline in Total Hip BMD at Month 24|BMD at the total hip was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748793|NCT00885170|Secondary|Percent Change From Baseline in Trochanter BMD at Month 12|BMD at the trochanter was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748794|NCT00885170|Secondary|Percent Change From Baseline in Trochanter BMD at Month 24|BMD at the trochanter was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748795|NCT00885170|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 12|BMD at the femoral neck was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748796|NCT00885170|Primary|Percentage of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to 24 months|The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.|||Percentage of participants|||Number
2748797|NCT00885170|Primary|Percentage of Participants Experiencing One or More Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to 25 months|The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.|||Percentage of participants|||Number
2748798|NCT00885170|Primary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24|BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
2748799|NCT00885118|Secondary|CLR,ss|renal clearance of the analyte at steady state determined over the dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2748800|NCT00885118|Secondary|fe0-24,ss|fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
2748801|NCT00885118|Secondary|Ae0-24,ss|amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol||Geometric Coefficient of Variation|Geometric Mean
2748802|NCT00885118|Secondary|RA,AUC|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||ratio||Geometric Coefficient of Variation|Geometric Mean
2748803|NCT00885118|Secondary|RA,Cmax|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||ratio||Geometric Coefficient of Variation|Geometric Mean
2748804|NCT00885118|Secondary|Vz/F,ss|apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||Liter||Geometric Coefficient of Variation|Geometric Mean
2748805|NCT00885118|Secondary|CL/F,ss|apparent clearance of the analyte in plasma after extravascular administration at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2748806|NCT00885118|Secondary|t1/2,ss|terminal half-life of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||hour||Geometric Coefficient of Variation|Geometric Mean
2748807|NCT00885118|Secondary|Cmax,ss|maximum measured concentration of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2748808|NCT00885118|Secondary|AUCτ,ss|area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2748809|NCT00885118|Secondary|CLR,0-24|renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2748810|NCT00885118|Secondary|fe0-24|fraction of the analyte excreted unchanged in urine from time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
2751989|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 4|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 4|FAS (LOCF)|||participants|||Number
2748812|NCT00885118|Secondary|Vz/F|apparent volume of distribution during the terminal phase λz following an extravascular dose|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||Liter||Geometric Coefficient of Variation|Geometric Mean
2748813|NCT00885118|Secondary|CL/F|apparent clearance of the analyte in plasma after extravascular administration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2748814|NCT00885118|Secondary|t1/2|terminal half-life of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||hour||Geometric Coefficient of Variation|Geometric Mean
2748815|NCT00885118|Secondary|Cmax|maximum measured concentration of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2748816|NCT00885118|Secondary|AUC0-∞|area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2748817|NCT00885118|Secondary|AUC0-tz|area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2748818|NCT00885118|Secondary|AUCτ,1|Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2748819|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)|||hr*uU/mL||Standard Error|Least Squares Mean
2748820|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)|||hr*pg/mL||Standard Error|Least Squares Mean
2748821|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)|||hr*mg/dL||Standard Error|Least Squares Mean
2748822|NCT00885118|Secondary|Change From Baseline in Fasting Insulin|Change from baseline in Fasting insulin to 28 days|baseline and 28 days|Full analysis set (FAS)|||uU/mL||Standard Error|Least Squares Mean
2748823|NCT00885118|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline in 1,5-anhydroglucitol to 28 days|baseline and 28 days|Full analysis set (FAS)|||ug/mL||Standard Error|Least Squares Mean
2748824|NCT00885118|Secondary|Change From Baseline in Fructosamine|Change from baseline in Fructosamine to 28 days|baseline and 28 days|Full analysis set (FAS)|||umol/L||Standard Error|Least Squares Mean
2748825|NCT00885118|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c to 28 days|baseline and 28 days|Full analysis set (FAS)|||percentage of HbA1c||Standard Error|Least Squares Mean
2748826|NCT00885118|Primary|Change From Baseline in 8-point Glucose|Change from baseline in 8-point glucose to 27 days|baseline and 27 days|Full analysis set (FAS)|||mg/dL||Standard Error|Least Squares Mean
2748827|NCT00885118|Primary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose to 28 days|baseline and 28 days|Full analysis set (FAS)|||mg/dL||Standard Error|Least Squares Mean
2748828|NCT00885118|Primary|Change From Baseline in Urine Glucose Excretion|Change from baseline in Urine glucose excretion to 28 days|baseline and 28 days|Full analysis set (FAS)|||mg||Standard Error|Least Squares Mean
2748829|NCT00885105|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.|Days 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population|||Percentage of Participants|||Number
2748830|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Antibodies to polio viruses were measured by a serum neutralization assay.|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2748831|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2748832|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.|"Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).~Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.~The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay."|Day 28 Post-vaccination|GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
2748833|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
2748834|NCT00885105|Primary|Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.|Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2748835|NCT00885092|Secondary|Percentage of Participants With Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.|||Percentage of participants|||Number
2748836|NCT00885092|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.|||Units on a scale||Standard Deviation|Mean
2748837|NCT00885092|Primary|Mean Ex-Vivo Wetting Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.|||Degrees||Standard Deviation|Mean
2748838|NCT00885079|Primary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.|Baseline, Weeks4||||units on a scale||Standard Deviation|Mean
2748839|NCT00885079|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups|Baseline, Weeks4||||units on a scale||Standard Deviation|Mean
2748840|NCT00884949|Primary|Subject Incidence of Treatment Emergent AEs|"The primary objective of the study was to evaluate the safety of weekly infusions of BMN 110 administered in escalating doses to subjects with MPS IVA.~The safety variable incidence of TEAE is summarized."|Entire Study, through week 84||||participants|||Number
2748841|NCT00884949|Secondary|Percent Change From Baseline in FVC|Percent Change from baseline in Forced Vital Capacity.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage of FVC||Standard Deviation|Mean
2748842|NCT00884949|Secondary|Percent Change From Baseline in MVV|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage of MVV||Standard Deviation|Mean
2748843|NCT00884949|Secondary|Percent Change From Baseline in uKS|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage of uKS||Standard Deviation|Mean
2748844|NCT00884949|Secondary|Change From Baseline in 3MSCT|Change from baseline in the 3-minute Stair Climb Test. Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.|||steps/min||Standard Deviation|Mean
2748845|NCT00884949|Secondary|Change From Baseline in 6MWT|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.|||meters||Standard Deviation|Mean
2751990|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 8|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 8|FAS (LOCF)|||participants|||Number
2748846|NCT00884910|Primary|Patient Preference|"Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference."|3 months post insertion, or at end of device life (whichever comes sooner)|All patients that participated in the study and finished it were analyzed|||Patients|||Number
2748847|NCT00884910|Secondary|Device Life Time|Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.|6 months|Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis.|||Days||Full Range|Median
2748848|NCT00884897|Secondary|To Determine Whether OT Improves Measures of Social Anxiety.|To determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.|Outcomes are compared between Baseline and endpoint||||units on a scale||Standard Deviation|Mean
2748849|NCT00884897|Primary|To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients|Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.|participants are assessed at baseline and end point||||units on a scale||Standard Deviation|Mean
2748850|NCT00884832|Secondary|Percentage of Days With FI Post-treatment Adjusted for Baseline|"The adjustment for baseline was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint."|4 weeks treatment||||percentage of days||Standard Error|Mean
2748851|NCT00884832|Secondary|Percentage of Days With Fecal Incontinence (FI)||4 weeks baseline, 4 weeks treatment||||percentage of days||Standard Error|Mean
2748852|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline|"The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The adjustment for baseline was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint."|4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
2748853|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
2748854|NCT00884832|Secondary|Percentage of Bowel Movements Preceded by Rectal Urgency|Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
2748855|NCT00884832|Secondary|Satisfaction With Treatment|"This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = Not satisfied at all (no relief of symptoms) to 100 = Completely satisfied (symptoms resolved). The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods."|4 weeks baseline, 4 week treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
2748856|NCT00884832|Secondary|Impact of Fecal Incontinence on Post-Treatment Quality of Life|"Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|after 4 weeks treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
2748857|NCT00884832|Secondary|Impact of Fecal Incontinence on Baseline Quality of Life|"Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|4 weeks baseline|Intent to treat analysis|||units on a scale||Standard Error|Mean
2748858|NCT00884832|Secondary|Mean Severity of Fecal Incontinence|The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
2748859|NCT00884832|Secondary|Mean Percentage of Bowel Movements Which Were Incontinent|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
2748860|NCT00884832|Secondary|Mean Number of Fecal Incontinence Episodes|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||number of episodes||Standard Error|Mean
2748862|NCT00884832|Primary|Mean Fecal Incontinence and Constipation Assessment (FICA) Score|The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1-6, 7-10, and 11-13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
2748863|NCT00884806|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7|Intent to treat: All participant who received regimen and had at least one on-therapy study visit.|||Units on a scale||Standard Deviation|Mean
2748864|NCT00884806|Primary|Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.|Day 7|Intent to treat: All participants who received regimen and had at least one on-therapy visit.|||Percentage of participants|||Number
2748865|NCT00884793|Secondary|"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"|Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry|12 weeks|All patients who had endoscopy at week 12.|||percentage change||Standard Error|Mean
2748866|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4% in the Ileum.|Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum|12 weeks|Includes all those who had endoscopy at week 12|||participants|||Number
2748867|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.|Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12.|12 weeks|Includes all with gut samples from week 12.|||participants|||Number
2748868|NCT00884793|Primary|Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum|Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum|12 weeks|We analyzed data from all subjects who had endosocopies at week 12.|||participants|||Number
2748869|NCT00884754|Primary|Time to Intubation (Seconds)||30-150 seconds (anticipated)||||seconds||Inter-Quartile Range|Median
2748870|NCT00884741|Other Pre-specified|Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)||Analysis can occur at or after time of primary outcome measure analysis.|||||||
2748871|NCT00884741|Other Pre-specified|Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)||Analysis can occur at or after time of primary outcome measure analysis.|||||||
2748872|NCT00884741|Secondary|Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0|AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.|Up to 30 days|Eligible randomized patients with adverse event data who started study treatment.|||participants|||Number
2748873|NCT00884741|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients|||months||95% Confidence Interval|Median
2748874|NCT00884741|Primary|Overall Survival (OS)|Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients|||months||95% Confidence Interval|Median
2748875|NCT00884611|Secondary|Mean Morning Blood Glucose (BG)|Desirable glucose level was 70-180 mg/mL. Average of all morning BG data is presented. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.|21 days|Participants who were treated and had data for the respective algorithm were included in the analysis.|||mg/dL||Standard Deviation|Mean
2748876|NCT00884611|Secondary|Percentage of Nights With CGM Values >180 mg/dL|Nights with CGM sensor values >180 mg/dL were considered to be undesirable. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.|21 days|Participants who were treated and had data for the respective algorithm were included in the analysis.|||percentage of nights|Nights||Number
2748877|NCT00884611|Primary|Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL|Nights with CGM sensor values < 60 mg/dL were considered to be undesirable. A Kalman filter-based model algorithm predicted whether the sensor glucose level would fall below 80 mg/dL and would suspend insulin delivery as needed. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.|21 days|Participants who were treated and had data for the respective algorithm were included in the analysis.|||percentage of nights|Nights||Number
2751991|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 6|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 6|FAS (LOCF)|||participants|||Number
2748878|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Punctate Corneal Staining Score|Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Baseline, Month 2||||Percentage of Patients|||Number
2748879|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Composite Symptom Score|Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.|Baseline, Month 2|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2748880|NCT00884585|Secondary|Percentage of Punctate Corneal Staining Responders|Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Month 2|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2748881|NCT00884585|Primary|Percentage of Treatment Responders|Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).|Baseline, Month 2|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2748882|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting|"The calculation of incidence of prophylaxis LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the Prophylactic LETE CRF), and the denominator was the number of routine prophylaxis infusions. Each infusion was classified in the infusion log (Prophylaxis/ On Demand/ Preventive), and participants were instructed to select On Demand if the infusion was to treat a bleed, even if the participant typically followed a prophylaxis regimen. Only the infusions classified as Prophylaxis were counted in this denominator."|100 exposure days to study medication (approx. 2 years)||||percentage of bleeding episodes||95% Confidence Interval|Number
2748883|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting|The calculation of incidence of on-demand LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the On Demand LETE CRF), and the denominator was the number of bleeding episodes treated in an on-demand setting. This denominator could include new bleeding episodes in prophylaxis participants breakthrough bleeds), and if subsequent on-demand doses for such a bleed met the on-demand LETE criteria, then an on-demand LETE was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||percentage of bleeds LETE||95% Confidence Interval|Number
2748884|NCT00884390|Secondary|Average Infusion Dose|The average infusion dose for each participant was calculated as his total factor consumption (in IU) divided by the number of infusions administered. Summary statistics were reported for both of these variables separately for those participants classified at baseline as following an on-demand regimen, and for those on a primary or secondary prophylaxis regimen.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||IU||Standard Deviation|Mean
2748885|NCT00884390|Secondary|TFC Following a Prophylaxis Regimen at Baseline for All Participants|The total amount (in IU) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||IU||Standard Deviation|Mean
2748886|NCT00884390|Secondary|Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants|The total amount (in International Units [IU]) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||International Units (IU)||Standard Deviation|Mean
2748887|NCT00884390|Secondary|Number of Participants With Breakthrough Bleeds|The number of participants with any breakthrough bleed was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||participants|||Number
2748888|NCT00884390|Secondary|Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion|"First, the bleed start time from the Infusion Log Diary CRF was used to determine the number of breakthrough bleeds that occurred ≤48 hours after an infusion marked as Prophylaxis (which had no associated bleed). If there was more than 1 bleed location (ie, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence. If a response was given, or if a bleed time was given, but On Demand was not listed as treatment type, it was still counted as an on-demand bleed for analyses/summaries. Bleeding episodes were not categorized as spontaneous (atraumatic) or traumatic."|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||bleeds|||Number
2748922|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF).|||milliliter||Standard Deviation|Mean
2748889|NCT00884390|Secondary|Number of ReFacto AF Infusions to Treat Each New Bleed|The Infusion Log Diary case report form (CRF) was used to determine the number of test article infusions administered to treat a bleed. This was calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time).|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of Infusions||Standard Deviation|Mean
2748890|NCT00884390|Secondary|Response Assessment of First On-demand Treatment of New Bleeds|"A 4-point scale of assessment of 'on-demand' treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as:~Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered.~Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered.~Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode.~No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens."|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of observations|||Number
2748891|NCT00884390|Secondary|Annualized Bleeding Rates (ABRs)|An ABR for each participant will be calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by his total therapy duration (in days), then multiplied by 365.25.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of bleeds||Standard Deviation|Mean
2748892|NCT00884390|Primary|Number of Participants With Clinically Significant Factor VIII Inhibitor Development|Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of participants||95% Confidence Interval|Number
2748893|NCT00884377|Secondary|Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial|Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol.|at baseline before treatment||||Participants|||Count of Participants
2748894|NCT00884377|Secondary|Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments|Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.|day 1 and day 10|Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10|||% of T-cells||95% Confidence Interval|Mean
2748895|NCT00884377|Secondary|Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments|Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.|day 1 and day 10|Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10|||populations of T-cells||95% Confidence Interval|Mean
2748896|NCT00884377|Secondary|Number of Participants With Solicited Adverse Events|To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events|Days 3, 7 and 10|Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days.|||subjects showing specified symptoms|||Number
2748897|NCT00884377|Secondary|Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure|"Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, clinical response was assessed by lesion and by subject. In addition, an overall response was assigned (healed or not healed) based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test."|12 months||||Participants|||Count of Participants
2748920|NCT00884273|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
2748898|NCT00884377|Primary|Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure|"Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, clinical response was assessed by lesion and by subject. In addition, an overall response was assigned (healed or not healed) based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test."|Assessment of cure is made at 2 months after treatment|A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002).|||Participants|||Count of Participants
2748899|NCT00884325|Secondary|Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)|Baseline - Week 2 - Week 4||||units on a scale||Inter-Quartile Range|Median
2748900|NCT00884325|Primary|Pruritus VAS Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.|Baseline - Week 2-Week 4||||units on a scale||Inter-Quartile Range|Median
2748901|NCT00884312|Secondary|Time to Progression|Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.|From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data Only participants with regimens that continued from the initial study without baseline being reset are included.|||months||95% Confidence Interval|Median
2748902|NCT00884312|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.~Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.~PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency."|From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data. Only participants with regimens that continued from the initial study without baseline being reset are included.|||months||95% Confidence Interval|Median
2748903|NCT00884312|Secondary|Overall Survival|Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.|From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.|||participants|||Number
2748904|NCT00884312|Primary|Number of Participants With Adverse Events|"Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0.~Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade).~A serious AE is one that met one or more of the following criteria:~Death~Life threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~A congenital anomaly/birth defect in the offspring of an exposed subject~Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above."|From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.|||participants|||Number
2748905|NCT00884312|Primary|Number of Participants With Peripheral Neuropathy|Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.|From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.|||participants|||Number
2748906|NCT00884286|Secondary|Overall Survival|Overall survival (OS) was to be calculated from the date of registration to the date of death from any cause. Patients with no documented death were to be censored at the last date they were known to be alive.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
2748907|NCT00884286|Secondary|Progression-free Survival|"Progression-free survival (PFS) was to be calculated from the date of registration to the date of first objective disease progression or death from any cause. Patients who were lost to follow-up without documentation of progression were to be censored at the last date they were assessed and found progression-free.~A patient receiving a new treatment in the absence of documented progression was to be considered as progressing at the time of re-treatment."|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
2748908|NCT00884286|Secondary|Time to Subsequent Chemotherapy|Time to subsequent therapy was to be calculated from the first infusion of the study drug to the start date of the subsequent therapy. Patients without subsequent therapy were to be censored at their last reported date.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
2748909|NCT00884286|Secondary|Time to Progression|Time to progression (TTP) was to be calculated from the first day of plitidepsin treatment to the date of disease progression.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
2748910|NCT00884286|Secondary|Duration of Response|Duration of response was defined as the time from the first documented objective response (CR, CRu or PR) to disease progression or death. Patients who had not progressed or died were to have their duration censored at the date of their last disease assessment.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|"The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.~The six responders belong to the Non-cutaneous PTCL cohort."|||months||95% Confidence Interval|Median
2748911|NCT00884286|Secondary|Time to Response Onset|Time to response onset was defined as the time from the first day of plitidepsin treatment to the first documentation of response.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|"The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.~Six responders belong to the Non-cutaneous PTCL cohort"|||weeks||95% Confidence Interval|Median
2748912|NCT00884286|Primary|Objective Response Rate|"The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkin's Lymphoma.~The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkin's Lymphoma (NHL)."|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous Peripheral T-cell Lymphoma (PTCL), and for the subset of treated patients with other lymphomas.|||Participants|||Count of Participants
2748913|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).|||milliliter||Standard Deviation|Mean
2748914|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety Analysis Set.|||participants|||Number
2748915|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety Analysis Set.|||participants|||Number
2748916|NCT00884273|Secondary|Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)|The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.|||scores on a scale||Standard Deviation|Mean
2748917|NCT00884273|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.|||scores on a scale||Standard Deviation|Mean
2748918|NCT00884273|Secondary|Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.|||nanograms per milliliter||Full Range|Median
2748919|NCT00884273|Secondary|Change in Serum Testosterone Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.|||nanograms per milliliter||Full Range|Median
2748923|NCT00884221|Secondary|Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
2748924|NCT00884221|Secondary|Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
2748925|NCT00884221|Secondary|Blastocyst Quality, Intention-to-treat (ITT) Analysis Set|"Blastocyst quality on day 5 was based on the blastocyst expansion and hatching status, inner cell mass grading and trophectoderm grading.~Excellent-quality blastocysts were defined as those with blastocyst expansion and hatching status 4, 5 or 6, inner cell mass grading A, and trophectoderm grading A or B. Good-quality blastocysts were defined as those with blastocyst expansion and hatching status 3, 4, 5 or 6, inner cell mass grading A or B, and trophectoderm grading A or B."|5 days after oocyte retrieval (120h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Number of blastocysts||Standard Deviation|Mean
2748926|NCT00884221|Secondary|Fertilization, Intention-to-treat (ITT) Analysis Set|Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized. Fertilization was estimated as (Number of oocytes with 2 pronuclei / number of metaphase II oocytes)*100|1 day after oocyte retrieval (19 h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of metaphase II oocytes||Standard Deviation|Mean
2748927|NCT00884221|Secondary|Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set|Oocyte retrieval took place 36h (± 2h) after hCG administration. At oocyte retrieval, the number of oocytes retrieved was recorded.|36 h after hCG|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Oocytes per participant||Standard Deviation|Mean
2748928|NCT00884221|Secondary|Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set|During the controlled ovarian stimulation, transvaginal ultrasound was performed to count the number of follicles and measure the size of the follicles.|Last stimulation day|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Follicles per participant||Standard Deviation|Mean
2748929|NCT00884221|Secondary|Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||nmol/L||Standard Deviation|Mean
2748930|NCT00884221|Secondary|Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||nmol/L||Standard Deviation|Mean
2748931|NCT00884221|Secondary|Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||pmol/L||Standard Deviation|Mean
2748932|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The per-protocol (PP) analysis set was defined as all randomized and exposed participants except those excluded as a result of major protocol deviations, such as significant non-compliance or other serious unforeseen deviations deemed to invalidate the data and affect the conclusions of the trial.|||Percentage of participants||Standard Deviation|Mean
2748933|NCT00884221|Secondary|Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||nmol/L||Standard Deviation|Mean
2748934|NCT00884221|Secondary|Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||IU/L||Standard Deviation|Mean
2748935|NCT00884221|Secondary|Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))*100|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
2748970|NCT00884052|Primary|Drug Half Life||Day 1 and Day 7|Subjects were grouped together to improve the reliability of the analysis. The publication of these results reported a grouped analysis because of the small number of subjects in the low dose group, The groups were not analyzed individually.|||hr||Standard Deviation|Mean
2748936|NCT00884221|Secondary|Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||IU/L||Standard Deviation|Mean
2748937|NCT00884221|Secondary|Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||pmol/L||Standard Deviation|Mean
2748938|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
2748939|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.|||degrees Celsius||Standard Deviation|Mean
2748940|NCT00884117|Secondary|Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|"ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table."|||degrees Celsius||Standard Deviation|Mean
2748941|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.|||degrees Celsius||Standard Deviation|Mean
2748942|NCT00884117|Secondary|Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||degrees Celsius||Standard Deviation|Mean
2748943|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
2748944|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
2748945|NCT00884117|Secondary|Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses.|Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data. The number of participants who provided evaluable data for each resistance status at Baseline (n) is shown in the table.|||percentage of participants|||Number
2748971|NCT00884052|Secondary|Levetiracetam Treated Number of Participants With Serious Adverse Events||7 Days||||Participants|||Count of Participants
2751992|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 4|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 4|FAS (LOCF)|||participants|||Number
2748946|NCT00884117|Secondary|Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses.|Days 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the specified visit. The number of participants who provided evaluable data for each resistance status at the specified visit (n) is shown in the table.|||percentage of participants|||Number
2748947|NCT00884117|Secondary|Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses.|Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the Day 6 visit. The number of participants who provided evaluable data for each resistance status at the Day 6 visit (n) is shown in the table.|||percentage of participants|||Number
2748948|NCT00884117|Secondary|Viral Load Among Children Treated With Oseltamivir|Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL.|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||log10 vp/mL||Standard Deviation|Mean
2748949|NCT00884117|Secondary|Viral Load Among Adults Treated With Oseltamivir|Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL).|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||log10 vp/mL||Standard Deviation|Mean
2748950|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
2748951|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
2748952|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
2748953|NCT00884117|Secondary|Time to Non-Detection of Viral RNA|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
2748954|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.|||participants|||Number
2748955|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.|||participants|||Number
2751993|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 8|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 8|FAS (LOCF)|||participants|||Number
2748956|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.|||participants|||Number
2748957|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.|||participants|||Number
2748958|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.|||participants|||Number
2748959|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.|||participants|||Number
2748960|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.|||participants|||Number
2748961|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.|||participants|||Number
2748962|NCT00884117|Primary|Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7|ALCIP Population. The “Number of Participants Analyzed” reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table.|||percentage of participants|||Number
2748963|NCT00884117|Primary|Number of Participants With Genotypic Resistance|"Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, H stands for hemagglutinin and N stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)"|Baseline (Day 1) and post-Baseline (Days 3, 6, 10)|All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The “Number of Participants Analyzed” reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown.|||participants|||Number
2748964|NCT00884065|Primary|Change in Active Internal Rotation After Intervention Minus Baseline|Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility|Baseline and the same day (just after intervention)||||Centimeters||Standard Deviation|Mean
2748965|NCT00884065|Primary|Change in Active External Rotation After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)||||Sexagesimal degrees||Standard Deviation|Mean
2748966|NCT00884065|Primary|Change in Active extensión Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)||||Sexagesimal degrees||Standard Deviation|Mean
2748967|NCT00884065|Primary|Change in Active Abduction Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination|Baseline and the same day (just after intervention)||||Sexagesimal degrees||Standard Deviation|Mean
2748968|NCT00884065|Primary|Change in Active Flexion Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)||||Sexagesimal Degrees||Standard Deviation|Mean
2748969|NCT00884065|Secondary|Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline|An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.|Baseline and the same day (just after intervention)||||Millimeters||Standard Deviation|Mean
2748972|NCT00884052|Primary|Drug Clearance||Day 1 and Day 7|Subjects were grouped together to improve the reliability of the analysis. The publication of these results reported a grouped analysis because of the small number of subjects in the low dose group, The groups were not analyzed individually.|||ml/min/kg||Standard Deviation|Mean
2748973|NCT00884039|Primary|Intraocular Pressure Within Normal Limits (<24 mm Hg)|Intraocular pressure was measured by Goldmann applanation tonometry.|1 month|Per protocol|||Participants|||Number
2748974|NCT00883779|Secondary|Median Follow-up Time During the Study|Median follow-up was calculated using 'Reverse Kaplan-Meier' analysis for Overall survival.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years])|FAS population.|||months||95% Confidence Interval|Median
2748975|NCT00883779|Secondary|Time to Deterioration in QOL Using FACT-L Version 4.0|"Time to deterioration in QoL is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in Total FACT-L or death on study. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||months||95% Confidence Interval|Median
2748976|NCT00883779|Secondary|Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0|"Total FACT-L score was defined as the sum of the TOI, Social Well Being (SWB) and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||percentage of participants|||Number
2748977|NCT00883779|Secondary|Time to Deterioration in TOI Using FACT-L Version 4.0|"Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. TOI is defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of QoL. A clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||months||95% Confidence Interval|Median
2748978|NCT00883779|Secondary|Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0|"TOI was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of quality of life (QoL). A clinically meaningful decline used to determine deterioration in TOI was greater than or equal to (≥) 6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||percentage of participants|||Number
2748979|NCT00883779|Secondary|Time to Symptomatic Progression|"Time to symptomatic progression was the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. LCS scores were obtained from a 7-item questionnaire from the FACT-L (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||months||95% Confidence Interval|Mean
2748988|NCT00883779|Secondary|Percentage of Participants Alive and Free From Disease Progression|Tumor response was evaluated according to RECIST (version 1.0). PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||percentage of participants|||Number
2749083|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment|The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.|9 weeks post initiation of ESA treatment|Participants who received treatment with an ESA|||percentage of participants||95% Confidence Interval|Number
2748980|NCT00883779|Secondary|Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||percentage of participants|||Number
2748981|NCT00883779|Secondary|Time to Progression|Time to progression is defined as the time between the date of randomization and the date of the first documented disease progression. Participants who have not progressed at the time of study completion (or data cut off) or who were lost to follow up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was latest. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Participants with no post baseline tumor assessments were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years])|FAS population.|||months||95% Confidence Interval|Median
2748982|NCT00883779|Secondary|Duration of Response|Duration of response is defined as the time between the date of first documented response (CR or PR, as determined by the RECIST criteria) and the date of first documented PD or death. Participants who did not progress or die after they had a confirmed response (CR or PR) were censored at the date of their last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was last. CR and PR are defined in Outcome Measure 7.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population participants who were responders (CR or PR).|||months||95% Confidence Interval|Median
2748983|NCT00883779|Secondary|Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||percentage of participants||95% Confidence Interval|Number
2748984|NCT00883779|Secondary|Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||percentage of participants||95% Confidence Interval|Number
2748985|NCT00883779|Secondary|Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups||Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."|||percentage of participants|||Number
2748986|NCT00883779|Secondary|Median Overall Survival (OS) Time-Overall and Among Different Subgroups|OS was defined as the time between the date of randomization and the date of death from any cause. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Participants with no post baseline information were censored at the time of randomization. OS among different subgroups of type of carcinoma, smoking habit, EGFR mutation type, KRAS mutation type, EGFR IHC test result type, and EGFR FISH result type. Analysis was performed using Kaplan-Meier method.|Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."|||months||95% Confidence Interval|Median
2748987|NCT00883779|Secondary|Median PFS Time Based on Different Subgroups|Tumor response was evaluated according to RECIST (version 1.0). PD was defined in outcome measure 1. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. PFS among different subgroups of type of carcinoma, smoking habit, epidermal growth factor receptor (EGFR) mutation type, KRAS mutation type, EGFR immunohistochemistry (IHC) test result type, and EGFR fluorescent in situ hybridization (FISH) result type.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|"FAS population. n is the number of participants evaluable under the specified category."|||months||95% Confidence Interval|Median
2749160|NCT00883051|Secondary|Change From Baseline in Heart Rate|Change from baseline in assessment of vital signs (heart rate).|Baseline through Day 14|Randomized participants who received at least 1 dose of study drug and had evaluable ECG parameters.|||beats per minute||Full Range|Median
2748989|NCT00883779|Primary|Median Progression Free Survival (PFS) Time|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||months||95% Confidence Interval|Median
2748990|NCT00883753|Secondary|Change From Baseline in FACIT-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."|||score on a scale||Standard Deviation|Mean
2748991|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."|||score on a scale||Standard Deviation|Mean
2748992|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
2748993|NCT00883753|Secondary|Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinical Remission is defined as a HAQ-DI score < 0.5.|Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
2748994|NCT00883753|Secondary|Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinically meaningful improvement is defined as a reduction from Baseline in the HAQ-DI score ≥ 0.2.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
2749001|NCT00883753|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."|||mm/hr||Standard Deviation|Mean
2751994|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 6|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 6|FAS (LOCF)|||participants|||Number
2748995|NCT00883753|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
2748996|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 90 (ACR90) Response|ACR90 response is defined as a ≥ 90 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
2748997|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 70 (ACR70) Response|ACR70 response is defined as a ≥ 70 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
2748998|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) Response|ACR50 response is defined as a ≥ 50 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
2748999|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR20) Response|ACR20 response was defined as a ≥ 20 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
2749000|NCT00883753|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."|||mg/dL||Standard Deviation|Mean
2751995|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 4|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 4|FAS (LOCF)|||participants|||Number
2749002|NCT00883753|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity VAS|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||mm||Standard Deviation|Mean
2749003|NCT00883753|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity VAS|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
2749004|NCT00883753|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||mm||Standard Deviation|Mean
2749005|NCT00883753|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||joint count||Standard Deviation|Mean
2749006|NCT00883753|Secondary|Change From Baseline in Tender Joint Count|68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||joint count||Standard Deviation|Mean
2749007|NCT00883753|Secondary|Change From Baseline in DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
2749008|NCT00883753|Secondary|Percentage of Participants With DAS28 Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission was defined as a DAS28 score < 2.6.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
2749009|NCT00883753|Secondary|Percentage of Participants With DAS28 Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Low Disease Activity was defined as a score of < 3.2.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
2749019|NCT00883753|Secondary|Percentage of Participants With Marked Lipid Abnormalities|Fasting blood samples were collected for Lipids: Cholesterol, Triglyceride, High-density lipoprotein (HDL) Cholesterol, Low-density lipoprotein (LDL) Cholesterol every 12 weeks and at follow-up in the Extension study and were sent to a central laboratory for analysis. Lipid abnormalities were defined as a High Cholesterol, High Triglyceride, Low HDL Cholesterol and a High LDL Cholesterol that occurred at any time in the extension study.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
2751996|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 8|SBP < 140 mmHg and DBP < 90 mmHg|week 8|FAS (LOCF)|||participants|||Number
2749010|NCT00883753|Secondary|Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Clinical meaningful improvement was defined as a ≥ 1.2 unit reduction in DAS28.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"Long Term Extension Intent-to-treat (LTE ITT) population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and the given time-point."|||percentage of participants|||Number
2749011|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Neutrophil Count During the Study|Blood samples were collected for a Neutrophil Count every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for Neutrophil Count during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.|||participants|||Number
2749012|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Total Cholesterol During the Study|Blood samples were collected for Total Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by worst value for Total Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.|||participants|||Number
2749013|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study|Blood samples were collected for LDL Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for LDL Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.|||participants|||Number
2749014|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for AST (SGOT) During the Study|Blood samples were collected for liver function test: Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) [AST (SGOT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for AST=40 Units/Liter. The number of participants categorized by worst value for AST(SGOT) during the study is reported: Normal (AST result is within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.|||participants|||Number
2749015|NCT00883753|Secondary|Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study|Blood samples were collected for liver function test: Alanine aminotransferase (serum glutamic-pyruvic transaminase) [ALT(SGPT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for ALT=55 Units/Liter. The number of participants categorized by the highest value for ALT/GPT during the study is reported: Normal (ALT result within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.|||participants|||Number
2749016|NCT00883753|Secondary|Percentage of Participants With AST Elevations > 3*ULN|Blood was collected for the Liver Function Test: Aspartate aminotransferase (AST) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 40 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
2749017|NCT00883753|Secondary|Percentage of Participants With ALT Elevations > 3*ULN|Blood samples were collected for the Liver Function Test: Alanine aminotransferase (ALT) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 55 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
2749018|NCT00883753|Secondary|Percentage of Participants With Adverse Events (AEs) of Special Interest|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Adverse Events of special interest for this study were: Infections (preferred term in the infection adverse event group term), Serious Infections (an infection that qualified as Serious Adverse Event), Infusion Reactions (occurred during infusion or within 24 hours of infusion), Major Cardiac AE (Myocardial Infarction/ Acute Coronary Syndrome), Stroke or Death.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
2749020|NCT00883753|Secondary|Time to Discontinuation of Tocilizumab Treatment for Any Cause|Time in days from start of the Core Study Day 1 to discontinuation of tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE). Participants who did not experience discontinuation of tocilizumab treatment were censored.|||days||95% Confidence Interval|Median
2749021|NCT00883753|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Any Cause|Percentage of participants who discontinued treatment with tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
2749022|NCT00883753|Secondary|Time to Withdrawal Due to an Adverse Event (AE)|Time to withdrawal was defined as the number of days from Core Study Day 1 to the first date of onset of the AE leading to discontinuation of tocilizumab.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension(LTE). Participants who did not experience an AE-related treatment discontinuation of tocilizumab were censored.|||days||95% Confidence Interval|Median
2749023|NCT00883753|Secondary|Percentage of Participants With Adverse Events Leading to Withdraw|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
2749024|NCT00883753|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants||95% Confidence Interval|Number
2749025|NCT00883740|Secondary|Subjective Total Sleep Time (sTST)|sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF|||Minutes||Standard Error|Least Squares Mean
2749026|NCT00883740|Secondary|Subjective Wake After Sleep Onset (sWASO)|sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant's daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF|||Minutes||Standard Error|Least Squares Mean
2749027|NCT00883740|Secondary|Daily Pain Score|Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores.|Daily up to Day 73 or ET|ITT; LOCF|||Units on a scale||Standard Error|Least Squares Mean
2749028|NCT00883740|Secondary|Latency of Sleep Onset (LSO)|LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant's daily SSQ.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF|||Minutes||Standard Error|Least Squares Mean
2749029|NCT00883740|Secondary|Sleep Quality|Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; Last observation carried forward (LOCF)|||Unit on a scale||Standard Error|Least Squares Mean
2749030|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT|||Units on a scale||Standard Error|Least Squares Mean
2749031|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT; n: number of participants at specific time points|||Units on a scale||Standard Error|Least Squares Mean
2749032|NCT00883740|Secondary|Slow Wave Sleep (SWS)|SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Percentage of total sleep time||Standard Error|Least Squares Mean
2751997|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 6|SBP < 140 mmHg and DBP < 90 mmHg|week 6|FAS (LOCF)|||participants|||Number
2749033|NCT00883740|Secondary|WASO by Each Quarter of the Night|WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
2749034|NCT00883740|Secondary|WASO by Hour of the Night|WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
2749035|NCT00883740|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
2749036|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 2)|NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Awakenings||Standard Error|Least Squares Mean
2749037|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 1)|NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Awakenings||Standard Error|Least Squares Mean
2749038|NCT00883740|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Percentage of time asleep||Standard Error|Least Squares Mean
2749039|NCT00883740|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
2749040|NCT00883740|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
2749041|NCT00883740|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation|||Minutes||Standard Error|Least Squares Mean
2749042|NCT00883740|Primary|Wake After Sleep Onset (WASO) at Weeks 5 and 11|WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)|Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations;|||Minutes||Standard Error|Least Squares Mean
2749043|NCT00883675|Primary|Febrile Neutropenia|The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.|2 months|Intent to treat|||participants|||Number
2749044|NCT00883558|Secondary|Number of Participants With Hypoglycemic Events|The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 29|Participants who received at least 1 dose of study drug.|||participants|||Number
2749045|NCT00883558|Secondary|Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring|Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.|Week 14 and Week 26|Participants that completed both treatment cycles with evaluable CGM data.|||hours||Standard Deviation|Mean
2749046|NCT00883558|Primary|Postprandial Glucose Excursion|A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.|Week 14 and Week 26|Participants who completed both treatment cycles with evaluable postprandial glucose data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2749047|NCT00883493|Secondary|Treatment Satisfaction Questionnaire (TSQ) Scores.|"The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.~Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||Scores on a scale||Standard Deviation|Mean
2749048|NCT00883493|Secondary|Change in the Sheehan Disability Scale (SDS) Total Score.|"The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).~Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||scores on a scale||95% Confidence Interval|Mean
2749049|NCT00883493|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.|"The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).~The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||scores on a scale||Standard Deviation|Mean
2749050|NCT00883493|Secondary|Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.|"The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.~PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality."|Baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||Scores on a scale||95% Confidence Interval|Mean
2749051|NCT00883493|Secondary|Change in Young Mania Rating Scale (YMRS) Total Score.|"The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours.~The mean change in YMRS Total score reported was calculated as baseline - week 8.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).|||scores on a scale||Standard Deviation|Mean
2749052|NCT00883493|Secondary|Change in the Clinical Global Impression Severity (CGI-S) Score.|"The reported mean change in the CGI-S score was calculated as baseline - week 8.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).|||scores on a scale||Standard Deviation|Mean
2749053|NCT00883493|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).~The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as anxious mood, tension or fears. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max)."|baseline, 8 weeks|"The analysis population was Per Protocol (PP)."|||scores on a scale||Standard Deviation|Mean
2749054|NCT00883493|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|"The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).~HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression."|Baseline, 8 Weeks|"The analysis population was Per Protocol (PP)."|||scores on a scale||Standard Deviation|Mean
2749055|NCT00883493|Secondary|Response Rate for MADRS.|"Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|baseline, week 8|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.|||percentage of participants|||Number
2749066|NCT00883246|Secondary|Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)|Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.|1 year|Lesions in patients with claudication at baseline|||percentage of lesions by Kaplan-Meier|Number of Lesions Analyzed||Number
2749056|NCT00883493|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|"The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 8 weeks|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.|||scores on a scale||Standard Deviation|Mean
2749057|NCT00883389|Primary|Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.|"Qualitative questionnaire with primary assessment: How useful do you think the Med-alert device will be for future healthcare. Response recorded based on a Likert scale with response of 0 = not useful, 1 = somewhat useful, 2 = extremely useful"|3 months||||Likert scale||Inter-Quartile Range|Median
2749058|NCT00883337|Secondary|Extension Treatment Period: ARR Poisson Regression Estimates|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.To account for the different treatment durations among participants, a Poisson Regression Model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 197 weeks)|ITT population.|||relapses per year||95% Confidence Interval|Number
2749059|NCT00883337|Secondary|Extension Treatment Period: Overview of AEs|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|Safety population. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||participants|||Number
2749060|NCT00883337|Secondary|Core Treatment Period: Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"Safety population: all randomized and treated participants. Participants were considered according to the drug actually received.~The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group."|||participants|||Number
2749061|NCT00883337|Secondary|Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores|TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).|48 weeks|ITT population.|||units on a scale||Standard Error|Least Squares Mean
2749062|NCT00883337|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|Baseline (before randomization) and 48 weeks|ITT population.|||units on a scale||Standard Error|Least Squares Mean
2749063|NCT00883337|Secondary|Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.|||relapses per year||95% Confidence Interval|Number
2749064|NCT00883337|Primary|Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints|"Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.|||percent probability||95% Confidence Interval|Number
2749065|NCT00883337|Primary|Core Treatment Period: Overview of Failures|"Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|Intent-to-treat population: all randomized participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||participants|||Number
2749300|NCT00881894|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||1/ hour (1/h)||Standard Deviation|Mean
2749067|NCT00883246|Secondary|Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)|Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.|3 months|Patients with wounds at baseline who had wound assessment scores at baseline and at 3 months.|||percentage of patients|||Number
2749068|NCT00883246|Secondary|Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)|Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.|One Year|All claudicants.|||percentage of patients by Kaplan-Meier|||Number
2749069|NCT00883246|Secondary|Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment|One Year|All patients with CLI.|||percentage of lesions|Number of Lesions Analyzed||Number
2749070|NCT00883246|Secondary|Secondary Patency (in Patients Treated for Claudication RCC 1-3)|Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.|One Year|All claudicants.|||percentage of lesions|Number of Lesions Analyzed||Number
2749071|NCT00883246|Secondary|Ankle-Brachial Index (in All Patients Enrolled)|Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.|1 Year|All patients with compressible arteries and a baseline ABI < 0.9.|||percentage of patients improved|||Number
2749072|NCT00883246|Secondary|Improvement in Rutherford Clinical Category (in All Patients Enrolled)|Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.|1 Year|All patients with RCC data at baseline and 1 year|||percentage of patients|||Number
2749073|NCT00883246|Secondary|Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)|WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.|Baseline and 1 Year|All subjects treated for claudication RCC 1-3 with completed WIQ forms|||units on a scale||Standard Deviation|Mean
2749074|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).|One Year||||percentage of patients|||Number
2749075|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).|30 Days||||percentage of patients|||Number
2749076|NCT00883246|Secondary|Procedural Success (in All Patients Enrolled)|Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.|Immediately following use of the SilverHawk and adjunctive devices|All lesions with angiographic core lab assessment of residual stenosis at the end of the procedure were included|||percentage of lesions|Number of Lesions Analyzed||Number
2749077|NCT00883246|Secondary|Device Success (in All Patients Enrolled)|Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.|Immediately following use of the SilverHawk device|Lesions with core angiographic laboratory measurements of residual stenosis|||percentage of Lesions|Number of Lesions Analyzed||Number
2749078|NCT00883246|Primary|Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.|One Year||||percentage of subjects by Kaplan-Meier|||Number
2749079|NCT00883246|Primary|Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)|The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.|One year|Kaplan-Meier estimate of the freedom from loss of primary patency in lesions (N=743 lesions)|||percentage of lesions by Kaplan Meier|Number of Lesions Analyzed||Number
2749080|NCT00883233|Primary|Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.|Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.|Week 4||||Scores on a scale||Standard Deviation|Mean
2749081|NCT00883181|Secondary|Number of Transfusions Per Participant in Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
2749082|NCT00883181|Secondary|Number of Participants With Systemic Transfusions in Cycles 1 to 8|Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
2749084|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749085|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749086|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749087|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 11 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749088|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749089|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin < 9 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749090|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response|Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||percentage of participants||95% Confidence Interval|Number
2749091|NCT00883181|Secondary|Change in Hemoglobin During ESA Treatment Phase||Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin measurements available at both time points.|||g/dL||Standard Deviation|Mean
2749092|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment|Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
2749093|NCT00883181|Secondary|Number of Clinical Visits in Cycles 1-8 by ESA Use|The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||visits per month||Standard Deviation|Mean
2749094|NCT00883181|Secondary|Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||participants|||Number
2749095|NCT00883181|Secondary|Reason for Treatment With Erythropoiesis-stimulating Agents|The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||participants|||Number
2749096|NCT00883181|Secondary|Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||weeks||Standard Deviation|Mean
2749301|NCT00881894|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
2749097|NCT00883181|Secondary|Time to Disease Progression|Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.|From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.|Full analysis set|||months||95% Confidence Interval|Median
2749098|NCT00883181|Secondary|Number of Participants With Hematological Toxicities|The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
2749099|NCT00883181|Secondary|Investigator Assessed Clinical Response at End of Treatment||End of treatment (approximately 24 weeks)|Full analysis set|||participants|||Number
2749100|NCT00883181|Secondary|Number of Participants With Unplanned Hospitalizations|Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
2749101|NCT00883181|Secondary|Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8|Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
2749102|NCT00883181|Secondary|Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned and with ≥ 15% chemotherapy dose reduction in any cycle.|||cycles|Cycles with ≥ 15% dose reduction||Number
2749103|NCT00883181|Secondary|Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy and had > 3 days delay in one or more cycles|||cycles|Cycles with > 3 days delay||Number
2749104|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Reductions|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)|||percentage of cycles|Total cycles||Number
2749105|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Reductions|A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)|||percentage of participants||95% Confidence Interval|Number
2749106|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Delays|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 days)|Full analysis set participants who received more than 1 cycle of chemotherapy|||percentage of cycles|Total cycles||Number
2749107|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8|A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy|||percentage of participants||95% Confidence Interval|Number
2749108|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF|||days||Standard Deviation|Mean
2749109|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim|||days||Standard Deviation|Mean
2749110|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any other G-CSF|||percentage of participants||95% Confidence Interval|Number
2749111|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF|||percentage of participants||95% Confidence Interval|Number
2749112|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim|||percentage of participants||95% Confidence Interval|Number
2749113|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with other G-CSF|||percentage of participants||95% Confidence Interval|Number
2749114|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with other G-CSF|||percentage of participants||95% Confidence Interval|Number
2749115|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF.|||days||Standard Deviation|Mean
2749116|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim|||days||Standard Deviation|Mean
2749117|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF|||days||Standard Deviation|Mean
2749118|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim|||days||Standard Deviation|Mean
2749119|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF|||percentage of participants||95% Confidence Interval|Number
2749120|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim|||percentage of participants||95% Confidence Interval|Number
2749161|NCT00883051|Secondary|Actual Time to Headache Relief and Time to Pain Free|"The participant answered Did your migraine pain go away completely (pain free) within 24 hours of dosing and record the time.~Actual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?."|up to 24 hours postdose|All randomized participants who received at least 1 dose of study drug.|||minutes||Standard Error|Mean
2749121|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF|||percentage of participants||95% Confidence Interval|Number
2749122|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim|||percentage of participants||95% Confidence Interval|Number
2749123|NCT00883181|Primary|Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received no prophylaxis or treatment with any G-CSF|||percentage of participants||95% Confidence Interval|Number
2749124|NCT00883181|Secondary|Number of Participants Who Received G-CSF During Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
2749125|NCT00883181|Primary|Percentage of Participants With Febrile Neutropenia (FN)|Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set; Note: One participant with breast cancer had disease stage missing.|||percentage of participants||95% Confidence Interval|Number
2749126|NCT00883168|Secondary|Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to treat (ITT)population includes all subjects(18 years or older) who had at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
2749127|NCT00883168|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who received at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
2749128|NCT00883168|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who had at least one post baseline dose efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
2749129|NCT00883129|Secondary|Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.|The number of participants who remained in the study at the listed time points are reported|Continuous assessment from randomization to 24 months||||Participants|||Count of Participants
2749130|NCT00883129|Secondary|Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death||Measured throughout the 2-year study||||Participants|||Count of Participants
2749131|NCT00883129|Secondary|Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)|Skin thickness is quantified using the modified Rodnan measurement method (mRSS), with a scale that ranges from 0 (no skin involvement) to a maximum of 51. The reported skin score is determined by a clinical assessment of skin thickness, which is performed by a trained reader, and represents the sum of individual assessments that are made in each of 17 body areas. Each area is given a score in the range of 0-3 (0 = normal; 1= mild thickness; 2 = moderate; 3 = severe thickness). A higher score represents more severe skin involvement.|Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||mRSS score||95% Confidence Interval|Mean
2749302|NCT00881894|Secondary|Tmax of Unconjugated Rotigotine|The Tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Full Range|Median
2749132|NCT00883129|Secondary|Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI asks questions related to 8 activity domains (dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities) with the patient's capacity to carry out each activity scored from 0 to 3. Scores across all domains are averaged and a higher score represents greater disability.|Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24|The analysis population contains all of those with data available at the defined time point.|||HAQ-DI Total Score||Standard Deviation|Mean
2749133|NCT00883129|Secondary|Transitional Dyspnea Index Score|Change in breathlessness was assessed using the Transitional Dyspnea Index, which compares current symptoms to those at baseline. Total score ranges from - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea.|Measured at Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||Transitional Dyspnea Index Score||95% Confidence Interval|Mean
2749134|NCT00883129|Secondary|Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)|Imaging of the whole lung (WL) is performed using a volumetric high resolution computerized tomography (HRCT) scan, which is then analyzed using a computer algorithm to determine the percentage of overall pixels exhibiting features characteristic for quantitative lung fibrosis (QLF). Higher percentages for QLF-WL therefore represent greater involvement by lung fibrosis.|Measured at baseline and Month 24|Analysis was carried out in the subset of subjects that had measurable HRCT scans at both study entry and 24 months|||% of lung exhibiting QLF||95% Confidence Interval|Mean
2749135|NCT00883129|Secondary|Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||DLCO %-pred||95% Confidence Interval|Mean
2749136|NCT00883129|Secondary|Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The TLC represents the total volume of air within the lung after taking the deepest breath possible and the TLC %-predicted represents the TLC expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The TLC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||TLC %-pred||95% Confidence Interval|Mean
2749137|NCT00883129|Primary|Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted. The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity.|Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||FVC %-pred||95% Confidence Interval|Mean
2749138|NCT00883116|Secondary|Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days|All participants who received at least 1 dose of ixabepilone|||Participants|||Number
2749139|NCT00883116|Secondary|Best Overall Response Rate|Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.|Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)|All randomized participants with measurable disease|||Percentage of participants||95% Confidence Interval|Number
2749140|NCT00883116|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.|Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months|All participants with measurable disease at randomization|||Months||95% Confidence Interval|Median
2749141|NCT00883116|Primary|Overall Survival (OS)|Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.|Date of randomization to date of death or last date censored to up to approximately 26 months|All randomized participants|||Months||95% Confidence Interval|Median
2751998|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 4|SBP < 140 mmHg and DBP < 90 mmHg|week 4|FAS (LOCF)|||participants|||Number
2749142|NCT00883103|Primary|Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain|A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.|Immediately after the examination|All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.|||Scores on a scale||Full Range|Median
2749143|NCT00883090|Secondary|Vital Signs|Number of participants with clinically significant vital signs. The vital signs measured included blood pressure, pulse rate and temperature. Clinically significant changes in vital signs were to be reported as adverse events.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.|||participants|||Number
2749144|NCT00883090|Secondary|Laboratory Safety Parameters|Number of participants with clinically significant laboratory safety parameter values. The laboratory safety parameters measured included serum chemistries, hematology and urinalysis.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.|||participants|||Number
2749145|NCT00883090|Secondary|Adverse Events|Number of participants with an adverse event|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.|||participants|||Number
2749146|NCT00883090|Primary|Mean Residence Time||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||days||Standard Deviation|Mean
2749147|NCT00883090|Primary|Volume of Distribution at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||mL/kg||Standard Deviation|Mean
2749148|NCT00883090|Primary|Clearance||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||mL/hr/kg||Standard Deviation|Mean
2749149|NCT00883090|Primary|Area Under the Curve at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units*hr/mL||Standard Deviation|Mean
2749150|NCT00883090|Primary|Terminal Half-life||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||days||Standard Deviation|Mean
2749151|NCT00883090|Primary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as the maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of FXIII (U/kg) administered.|12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units/mL/Units/kg||Standard Deviation|Mean
2749152|NCT00883090|Primary|Time to Peak Concentration||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||hr||Standard Deviation|Mean
2749153|NCT00883090|Primary|Trough FXIII Concentration at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units/mL||Standard Deviation|Mean
2749154|NCT00883090|Primary|Peak FXIII Concentration at Steady State||12 weeks|The analysis population was the pharmacokinetic (PK) population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units/mL||Standard Deviation|Mean
2749155|NCT00883051|Secondary|Number of Serious Adverse Events|A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|up to 8 weeks|All randomized participants who received at least 1 dose of study drug excluding one participant who was lost to follow-up and did not report adverse events.|||adverse events|||Number
2749156|NCT00883051|Secondary|Change From Baseline in Hematology Tests|Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.|Baseline through Day 14|All randomized participants who received at least 1 dose of study drug and had evaluable blood parameters.|||million cells per liter||Standard Error|Mean
2749157|NCT00883051|Secondary|Percentage of Participants With Change From Baseline in Physical Examination Parameters|Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.|Baseline through Day 14|All randomized participants who received at last 1 dose of study drug and had a physical examination.|||percentage of participants|||Number
2749158|NCT00883051|Secondary|Change From Baseline in Diastolic Blood Pressure|Change from baseline in vital signs (diastolic blood pressure).|Baseline through Day 14|Randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.|||millimeters of mercury||Full Range|Median
2749159|NCT00883051|Secondary|Change From Baseline in Systolic Blood Pressure|Change from baseline in vital signs (systolic blood pressure).|Baseline through Day 14|All randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.|||millimeters of mercury||Full Range|Median
2749162|NCT00883051|Secondary|Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)|PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.|2 hours postdose|All randomized participants who received at least 1 dose of study drug and had a PGI-I measurement post dose.|||Participants|||Count of Participants
2749163|NCT00883051|Secondary|Percentage of Participants Who Used Rescue Medication|Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).|Postdose 2 through 24 hours|Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.|||percentage of participants|||Number
2749164|NCT00883051|Secondary|Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)|"The participant is asked How much is the migraine interfering with normal activities? on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference."|2 hours postdose|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||Participants|||Count of Participants
2749165|NCT00883051|Secondary|Percentage of Participants With Vomiting|Percentage of participants with vomiting 2 hours post treatment.|2 hours postdose|Randomized participants who received a dose of study drug and had postdose symptom assessments.|||percentage of participants|||Number
2749166|NCT00883051|Secondary|Percentage of Participants Who Have Photophobia|Percentage of participants who have symptoms of photophobia two hours post treatment.|2 hours postdose|Randomized participants who received a dose of study drug and had postdose symptom assessments.|||percentage of participants|||Number
2749167|NCT00883051|Secondary|Percentage of Participants Who Have Symptoms Phonophobia|Percentage of participants who have symptoms of phonophobia two hours post treatment.|2 hours postdose|Randomized participants who received a dose of study drug and had postdose symptom assessments.|||percentage of participants|||Number
2749168|NCT00883051|Secondary|Percentage of Participants Who Have Symptoms of Nausea|Percentage of participants who have symptoms of nausea two hours post treatment.|2 hours postdose|Randomized participants who received a dose of study drug and had postdose symptom assessments.|||percentage of participants|||Number
2749169|NCT00883051|Secondary|Percentage of Participants With Headache Severity (4 Point Rating Scale)|Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.|2 hours postdose|Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.|||percentage of participants|||Number
2749170|NCT00883051|Secondary|Percentage of Participants With Headache Recurrence|Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.|up to 24 hours postdose|Randomized participants who received a dose of study drug, were pain free at 2 hours postdose and had postdose headache severity or symptom assessments.|||percentage of participants|||Number
2749171|NCT00883051|Secondary|Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose|The percentage of participants defined as mild, moderate, or severe headache pain becoming none.|2 hours post dose|All randomized participants who received at least 1 dose of study drug, a 2 hour postdose evaluation and evaluable headache relief data.|||percentage of participants|||Number
2749172|NCT00883051|Primary|Percentage of Participants With Headache Response|Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.|2 hours postdose|All randomized participants who received at least 1 dose of study drug and had a post-baseline evaluation.|||percentage of participants|||Number
2749173|NCT00882999|Secondary|Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)|Cell surface marker cluster designation (CD)19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive B cells (CD19+IgD+CD27-); immature/transitional (immature/tran) B cells (CD19+IgD-CD27-); switched memory B cells (CD19+IgD-CD27+); and non-switched memory B cells (CD19+IgD+CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count.|Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48|Randomized participants who had peripheral blood B cell subset cell counts at the specified time points.|||cells per microliter (cells/µL)||Standard Deviation|Mean
2749174|NCT00882999|Secondary|Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]|The percentage of participants with ADA=[(number of participants who had ADA)/(number of participants assessed)]*100.|Baseline, Weeks 4, 12, 24, 48, 60, 72, 84, 96, and 108|Randomized participants who had an ADA assessment at the specified time periods.|||percentage of participants|||Number
2749175|NCT00882999|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)|AUCtau,ss was obtained by conducting a simulation consisting of 1000 participants, which were then used to determine the noncompartmental PK parameters for each regimen.|Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.|Randomized participants who had evaluable PK data.|||micrograms/milliliter*hours (mcg/mL*h)||Standard Deviation|Median
2749183|NCT00882999|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS is a rating scale for quantifying disability in multiple sclerosis (MS) participants. The EDSS has 8 functional systems (pyramidal, cerebellar, brain stem, sensory, bowel and bladder, visual, cerebral, and other) each rated on a scale from 0 (normal) to 5 (severe disability) or 0 (normal) to 6 (severe disability). The EDSS score was computed based on an algorithm of these components, and scores ranged from 0.0 (normal neurological exam) to 10.0 (death due to MS) in increments of 0.5.|Weeks 12, 24, and 48|Randomized participants who had EDSS scores at the specified time points.|||units on a scale||Standard Deviation|Mean
2751999|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 8|DBP < 90 mmHg|week 8|FAS (LOCF)|||participants|||Number
2749176|NCT00882999|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores|The SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores were calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status or function. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).|Weeks 12, 24, and 48|Randomized participants who had SF-36 component scores at the specified time points.|||units on a scale||Standard Deviation|Mean
2749177|NCT00882999|Secondary|16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)|The QIDS-SR16 is a 16-item participant-rated measure of depressive symptomatology. Each item corresponds to 1 of 9 criterion domains for depression: change in sleep disturbance [question (Q) 1 through Q4], sad mood (Q5), decrease or increase in appetite and weight (Q6 through Q9), concentration (Q10), self-criticism (Q11), suicidal ideation (Q12), interest (Q13), energy/fatigue (Q14), and psychomotor agitation and retardation (Q15 and Q16). Each question was scored 0 (no problems) to 3 (increased symptoms). The total score=(the highest score from Q1 through Q4)+(Q5 score)+(the highest score from Q6 through Q9)+(the total score for each Q10 through Q14)+(the highest score from Q15 and Q16). A total score of 0 through 5 was considered no depression likely, 6 through 10 was mild depression, 11 through 15 was moderate depression, 16 through 20 was severe depression, and 21 or over was very severe depression.|Weeks 12, 24, and 48|Randomized participants who had QIDS-SR16 scores at the specified time points.|||units on a scale||Standard Deviation|Mean
2749178|NCT00882999|Secondary|Visual Analog Scale (VAS) of Wellbeing|"The VAS is a 100-millimeter (mm) horizontal line marked with 0 mm = poor and 100 mm = excellent. Participants were asked to assess their wellbeing by making a vertical mark on the scale. The score was computed as the distance from 0 mm to the vertical mark."|Weeks 12, 24, and 48|Randomized participants who had VAS of Wellbeing scores at the specified time points.|||mm||Standard Deviation|Mean
2749179|NCT00882999|Secondary|Multiple Sclerosis Functional Composite Scale (MSFC)|The MSFC is a composite scale consisting of 3 components [Timed 25-Foot Walk, 9-Hole Peg Test (9-HPT), and 3-Second Paced Auditory Serial Addition Test (PASAT-3)]. The Timed 25-Foot Walk was a quantitative measure of lower extremity function. The 9-HPT was a quantitative measure of upper extremity (arm and hand) function. The PASAT-3 was a measure of cognitive function that specifically assessed auditory information processing speed and flexibility, as well as calculation ability. Component scores ranged from 0 to 60 and were converted to standard scores (z-scores). The MSFC score was calculated as the average of the 3 standardized component scores. Higher MSFC scores reflected better neurological function.|Weeks 12, 24, and 48|Randomized participants who had MSFC scores at the specified time points.|||units on a scale||Standard Deviation|Mean
2749180|NCT00882999|Secondary|Annualized Relapse Rate (ARR) at Week 24 and Week 48|The number of confirmed relapses per year, ARR=[(number of relapses from baseline through Week 24 or baseline through Week 48)/(the time in days between the same interval)]*365.25. A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may have not required systemic corticosteroid treatment.|Baseline through Week 24 and Baseline through Week 48|Randomized participants who had a relapse assessment for the specified time periods.|||relapses per year||Standard Deviation|Mean
2749181|NCT00882999|Secondary|Percentage of Relapse-Free Participants|A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. Percentage of relapse-free participants=[(number of participants who did not relapse)/(number of pts assessed)]*100.|Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)|Randomized participants who had a relapse assessment at the specified time points.|||percentage of participants|||Number
2749182|NCT00882999|Secondary|Time to First Relapse|A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. If a relapse did not occur during the specified time frame, the time to the first confirmed relapse was censored to the date of the participant's last available visit at or prior to Week 24, Week 48, and Week 48 for the respective time frames.|Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48|Randomized participants who had a relapse assessment for the specified time periods. Twenty-one (21), 24, 24, 28, 23, 26, and 26 participants were censored in the following arms respectively: 4 mg, 12 mg, 40 mg, and 120 mg LY2127399 Q4W, 4 mg and 120 mg LY2127399 Q12W, and placebo.|||days||Standard Deviation|Mean
2749184|NCT00882999|Secondary|Total Volume of T2-Weighted MRI Lesions|The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.|Weeks 4, 8, 12, 16, 20, 24, 36, and 48|Randomized participants who had a T2-weighted MRI assessment at the specified time points.|||mL||Standard Error|Least Squares Mean
2749186|NCT00882999|Secondary|Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan|Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of new T1-weighted lesions per scan was obtained from the number new T1-weighted lesions observed during a specified week divided by the number of scans performed that same week.|Weeks 4, 8, 12, 16, 20, 24, 36, and 48|Randomized participants who had a Gd-enhancing T1-weighted MRI assessment at the specified time points.|||lesions per scan||Standard Deviation|Mean
2749187|NCT00882999|Secondary|Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan|Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. Least squares (LS) mean was calculated using an analysis of variance (ANOVA).|Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48|Randomized participants who had a Gd-enhancing T1-weighted MRI assessment at the specified time points.|||lesions per scan||Standard Error|Least Squares Mean
2749188|NCT00882999|Primary|Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24|Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.|Weeks 12, 16, 20, and 24|Randomized participants who had a Gd-enhancing T1-weighted MRI lesion for at least 1 time point among Weeks 12, 16, 20, or 24.|||lesions per scan||Standard Deviation|Mean
2749189|NCT00882921|Secondary|Change From Baseline in uGAG Levels to 109 Weeks|Urine GAG|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase. The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.|||mcg/mg||Standard Deviation|Mean
2749190|NCT00882921|Primary|Infusion-Related Adverse Event (IRAE) Rates Between IgG Anti-idursulfase Antibody Positive (Ab+) and Anti-idursulfase IgG Antibody Negative (Ab-) Patients|The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase.|||IRAE/Week|||Number
2749191|NCT00882908|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng*h/mL||Full Range|Median
2749192|NCT00882908|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng/mL||Full Range|Median
2749193|NCT00882908|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.|Baseline (Day 1) up to Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Participants|||Number
2749194|NCT00882908|Secondary|The Number of Participants With Viral Relapse|The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Participants|||Number
2749195|NCT00882908|Secondary|Number of Participants With Viral Breakthrough|The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).|Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Participants|||Number
2749196|NCT00882908|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.|Up to Week 36 or 52|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749197|NCT00882908|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2752000|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 6|DBP < 90 mmHg|week 6|FAS (LOCF)|||participants|||Number
2749198|NCT00882908|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Baseline (Day 1) and Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749199|NCT00882908|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749200|NCT00882908|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.|Week 48 or 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749201|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.|Baseline (Day 1) and Weeks, 2, 4, 8, and 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749202|NCT00882908|Secondary|The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749203|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749204|NCT00882908|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
2749205|NCT00882778|Secondary|Number of Physician Reported Outcome Assessment in Prophylaxis in Percentage of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days|||percentage of patients|||Number
2749206|NCT00882778|Secondary|Physician Reported Outcome Assessment in Prophylaxis in Number of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days|||patients|||Number
2749207|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months.|||change in days per month||Standard Deviation|Mean
2749208|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis of approximately 6 months.|||change in days per month||Standard Deviation|Mean
2749494|NCT00880191|Primary|Comparison of Percentage of Complete Responders|Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 2 through 6||||percentage of participants|||Number
2749209|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (RFVIIa) for at least 30 days.|||change in days per month||Standard Deviation|Mean
2749210|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||change in events per month||Standard Deviation|Mean
2749211|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||change in events per month||Standard Deviation|Mean
2749212|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations, and Hospital Admissions Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days|||change in events per month||Standard Deviation|Mean
2749213|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Frequent Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (= 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected in these patients. Bleed episodes with no recorded locations were not included in the analysis|||percent change (%) in bleeds per month|||Number
2749214|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (defined as 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected. Bleed episodes with no recorded locations were not included in the analysis|||percent change (%) in bleeds per month|||Number
2749215|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
2749216|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
2749217|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
2749218|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
2749219|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
2749220|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
2749221|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749222|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749223|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749224|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749225|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749226|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2752001|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 4|DBP < 90 mmHg|week 4|FAS (LOCF)|||participants|||Number
2749227|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749228|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749229|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Frequent Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749230|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749231|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Frequent Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749232|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
2749233|NCT00882713|Secondary|Mean Change From Baseline in Weight Over Time|Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).|Week 16 and Week 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.|||kilogram||Standard Deviation|Mean
2749234|NCT00882713|Secondary|Mean Change From Baseline in Blood Pressure Over Time|Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.|||millimeter of mercury||Standard Deviation|Mean
2749235|NCT00882713|Secondary|Mean Change From Baseline in Pulse Rate Over Time|Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.|||beats per minute||Standard Deviation|Mean
2749236|NCT00882713|Secondary|Mean Transferrin Saturation Levels Over Time|The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
2749303|NCT00881894|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*kg||Standard Deviation|Mean
2749237|NCT00882713|Secondary|Mean Ferritin Levels Over Time|The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||mcg/L||Standard Deviation|Mean
2749238|NCT00882713|Secondary|Mean C-Reactive Protein Levels Over Time|The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||miligrams/L||Standard Deviation|Mean
2749239|NCT00882713|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||micromole/L||Standard Deviation|Mean
2749240|NCT00882713|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||milimole/L||Standard Deviation|Mean
2749241|NCT00882713|Secondary|Mean White Blood Cells and Thrombocytes Over Time|The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||10^9 cells/L||Standard Deviation|Mean
2749242|NCT00882713|Secondary|Mean Albumin Levels Over Time|The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not. Out of 194, one participant was excluded from the ITT population due to missing hemoglobin measurement and C.E.R.A medication after Week 0.|||g/L||Standard Deviation|Mean
2749243|NCT00882713|Secondary|Mean Hematocrit Levels Over Time|The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2749244|NCT00882713|Secondary|Mean Hemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||g/dL||Standard Deviation|Mean
2749245|NCT00882713|Secondary|Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.|||Number of RBCs transfusion|||Number
2749246|NCT00882713|Secondary|Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP|Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||Percentage of participants|||Number
2749247|NCT00882713|Secondary|Number of Participants With Any Adverse Events or Serious Adverse Events|An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
2749340|NCT00881504|Secondary|Safety and Toxicity|The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.|8 weeks||||participants|||Number
2749248|NCT00882713|Secondary|Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP|Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||Days||Standard Deviation|Mean
2749249|NCT00882713|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP|Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||Percentage of participants||95% Confidence Interval|Number
2749250|NCT00882713|Secondary|Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period|Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.|SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||g/dL||Standard Deviation|Mean
2749251|NCT00882713|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period|The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.|EEP (Week 17 to Week 24)|The per-protocol (PP) population included all participants from the intention-to-treat (ITT) population, who fulfilled inclusion/exclusion criteria as per the study protocol. A total of 123 participants were included in the PP population.|||Percentage of participants||95% Confidence Interval|Number
2749252|NCT00882687|Secondary|Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
2749253|NCT00882687|Secondary|Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.|Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
2749254|NCT00882687|Primary|Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 14 (20 minutes post CAC 9)|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
2749255|NCT00882687|Primary|Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 7 (20 minutes post CAC 6)|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
2749256|NCT00882687|Primary|Ocular Itching at Day 14 (7 Minutes Post CAC 9)|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.|Baseline to Day 14 (7 minutes post CAC 9)|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
2749257|NCT00882687|Primary|Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.|Baseline to Day 7 (7 minutes post CAC 6)|Intent-to-treat (ITT) population with last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2749258|NCT00882661|Secondary|Satisfaction|Patient satisfaction (definitely/mostly): proportion of patients|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Patient Satisfaction data was available for 78 non-randomized SECURE-C patients, 139 randomized SECURE-C patients and 115 control patients at 24 months.|||participants|||Number
2749259|NCT00882661|Secondary|SF-36 MCS|Health Status Survey SF-36 mental composite scores: 15% improvement from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 MCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.|||participants|||Number
2749260|NCT00882661|Secondary|SF-36 PCS|Health Status Survey SF-36 physical composite scores: 15% improvement from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 PCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.|||participants|||Number
2749261|NCT00882661|Secondary|Right Arm Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Right Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C patients, 133 randomized SECURE-C patients and 108 control patients at 24 months.|||participants|||Number
2749262|NCT00882661|Secondary|Left Arm Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Left Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.|||participants|||Number
2749263|NCT00882661|Secondary|Neck Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.|||participants|||Number
2749264|NCT00882661|Secondary|Neck Disability Index (NDI)|Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Disability Index (NDI) data was available for 78 Non-randomized SECURE-C patients,139 randomized SECURE-C patients and 116 control patients at 24 months.|||participants|||Number
2749265|NCT00882661|Primary|Individual Patient Overall Success|Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.|||participants|||Number
2749266|NCT00882583|Primary|MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B|The Maximum Tolerated Dose (MTD) for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT.|Last day of Radiation|MTD not reached. Data table reports dosage received by each participant. Study closed to slow accrual.|||Participants|||Count of Participants
2749267|NCT00882557|Secondary|Treatment-emergent Adverse Events|Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.|Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).|Safety population, defined as all subjects who received at least one dose of daptomycin|||participants|||Number
2749268|NCT00882557|Other Pre-specified|Volume of Distribution|Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.|Up to 68 hours post dose||||mL/kg||Full Range|Median
2749269|NCT00882557|Other Pre-specified|Clearance of Daptomycin|Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.|Up to 68 hours post dose|PK Population - defined as all subjects who received both doses of daptomycin|||mL/hr/kg||Full Range|Median
2749270|NCT00882557|Other Pre-specified|Half-life|Apparent terminal half-life.|Up to 68 hours post dose||||Hours||Full Range|Median
2749271|NCT00882557|Other Pre-specified|Time to Maximum Concentration|Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.|Up to 68 hours post dose||||Hours||Full Range|Median
2749272|NCT00882557|Other Pre-specified|Maximum Plasma Concentration|Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|PK Population - defined as all subjects who received both doses of daptomycin|||ug/mL||Full Range|Median
2749273|NCT00882557|Primary|Evaluation of Area Under the Curve From Time 0 to Infinity|Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|The primary endpoints are measured on the PK population, defined as all subjects who received both the 6 mg/kg dose and 9 mg/kg dose|||hr*ug/mL||Full Range|Median
2749274|NCT00882518|Secondary|Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42|6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
2749275|NCT00882518|Secondary|Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42|"6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least minimally improved at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient's change from baseline CGI on a seven-point scale (1=Very much improved, 7=Very much worse.)"|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||percentage of participants|||Number
2749276|NCT00882518|Secondary|Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.~1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme."|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||Percentage of participants|||Number
2749277|NCT00882518|Secondary|Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
2749278|NCT00882518|Secondary|Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
2749279|NCT00882518|Secondary|Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42|The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
2749280|NCT00882518|Secondary|Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
2749281|NCT00882518|Secondary|Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
2749282|NCT00882518|Primary|Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42|6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.|Baseline and 6 weeks|Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.|||scores on a scale||Standard Error|Least Squares Mean
2749283|NCT00882440|Secondary|Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8||6 hours post dose at Baseline and 8 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2749531|NCT00880009|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749284|NCT00882440|Primary|Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8||24 hours post dose at Baseline and Week 8|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
2749285|NCT00882440|Secondary|Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8|"Patients in Category I (defined as excellent in protocol) if SuDBP was <90 mmHg, Category II (defined as good in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as fair or inadequate in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg."|24 hours post dose at Week 8|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
2749286|NCT00882362|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Change from baseline to Last Observation Carried Forward (LOCF).~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline(Day 1), Week52 or at discontinuation||||Rating Score||Standard Error|Mean
2749287|NCT00882310|Secondary|Score on FACT-Hep (Version 4)|"Quality of life score of patients treated with the adjuvant GTX regimen using, the FACT-Hep (Version 4), a sensitive measure of quality of life.~Data was not analyzed because original PI left institution before data analysis was completed."|Prior to starting treatment, after 3 months of treatment, and at the end of study visit.|||||||
2749288|NCT00882310|Secondary|Time to Death|"Median recurrence free survival in patients with non-metastatic, resected pancreatic cancer treated with adjuvant GTX.~Data was not analyzed because original PI left institution before data analysis was completed."|At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.|||||||
2749289|NCT00882310|Primary|Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)|"Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.~Data was not analyzed because original PI left institution before data analysis was completed."|At days 4, 11, and follow-up.|||||||
2749290|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 33|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.|||percentage of DNA||Standard Deviation|Mean
2749291|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 5|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.|||percentage of DNA||Standard Deviation|Mean
2749292|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 0||||percentage of DNA||Standard Deviation|Mean
2749293|NCT00882206|Primary|Response to Treatment|Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33)|Day 33|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.|||participants|||Number
2749294|NCT00882115|Primary|Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention|Change of total nasal cell count in response to a standard diesel exhaust particle (DEP) challenge was determined by counting the total number of cells (leukocytes) recovered from nasal lavage fluid at 0 hr (just prior to DEP dosing), 6 hr and 24 hr later in participants who consuming BSE for 4 days, or without consuming BSE (control). Nasal challenges were performed with 300 microgram a standard DEP in 200 microliter saline.|0, 6 and 24 hours at Control visit and BSE visit (Day 4 of intervention)|All participants with baseline (0 hr), and 6 hr and 24 hr post-baseline nasal cell count measurement.|||log cells/mL||Standard Deviation|Mean
2749295|NCT00882102|Primary|Number of Participants With a Complete Response|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).|Day 14 of first cycle||||Participants|||Number
2749296|NCT00881959|Primary|Non -Inferiority of Dermis to Alloderm|Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.|12 months||||mm||Standard Deviation|Mean
2749297|NCT00881894|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)|||mg||Standard Deviation|Mean
2749298|NCT00881894|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||L/ h||Standard Deviation|Mean
2749299|NCT00881894|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
2749304|NCT00881894|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL) / mg||Standard Deviation|Mean
2749305|NCT00881894|Secondary|AUC(0-tz)Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h*kg||Standard Deviation|Mean
2749306|NCT00881894|Secondary|AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
2749307|NCT00881894|Secondary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
2749308|NCT00881894|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||ng/ mL||Standard Deviation|Mean
2749309|NCT00881894|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
2749310|NCT00881868|Primary|Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)|Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).|baseline to week 4|ITT, LOCF|||participants|||Number
2749311|NCT00881868|Secondary|Number of Participants in Each Category of Pruritus at Baseline and Week 4|Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.|baseline to week 4||||participants|||Number
2749312|NCT00881868|Secondary|Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4|Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.|baseline to week 4||||participants|||Number
2749313|NCT00881868|Secondary|Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4|Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.|baseline to week 4||||participants|||Number
2749314|NCT00881751|Secondary|Response Rate|Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.|From day 1 drug administration until 30 days after the last dose of study drug.|Responders include complete and partial responders defined by RECIST 1.1 criteria.|||percentage of participants|||Number
2749315|NCT00881751|Secondary|Number of SAEs Experienced|The study will report the number of SAEs experienced in each arm. All patients who receive any study drug will be evaluable for toxicity.|From day 1 of drug administration until 30 days after the last dose of study drug.|Patients who received at least one dose of study drug were included in this analysis.|||serious adverse events|||Number
2749316|NCT00881751|Secondary|Event-free Survival|EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.|From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.||||Months||95% Confidence Interval|Median
2749317|NCT00881751|Primary|Overall Survival|Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.|from date of day 1 until the date of death|Only subjects who received one dose of study drug were considered for this outcome. 5 subjects enrolled to Arm II did not receive any study drug and were not evaluable for this outcome.|||Months||95% Confidence Interval|Median
2749318|NCT00881712|Secondary|Correlation of Functional CT-PET Imaging With Treatment Outcomes||Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years|This data was not collected as study was terminated early.||||||
2749319|NCT00881712|Secondary|Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy||Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually|This data was not collected as study was terminated early.||||||
2749320|NCT00881712|Secondary|Percentage of Patients Alive at 5 Years||Five years following radiation treatment|Thirteen enrolled patients that completed treatment.|||percentage of patients|||Number
2749321|NCT00881712|Secondary|Percentage of Patients With Disease Control|"Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.), as accurate."|Following treatment every 6 months for 2 years, then annually for 4 years.|Thirteen enrolled patients that completed treatment|||percentage of participants|||Number
2749322|NCT00881712|Primary|Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities||Six months after end of radiation therapy||||participants|||Number
2749323|NCT00881647|Primary|Sleep Efficiency (SE)|SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation||||percentage of time||Standard Deviation|Mean
2749324|NCT00881647|Primary|Minutes of Wake After Sleep Onset (WASO)|WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|per protocol|||Minutes||Standard Deviation|Mean
2749325|NCT00881647|Primary|Sleep Latency (SL)|In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation||||minutes||Standard Deviation|Mean
2749326|NCT00881621|Secondary|Adverse Events|Grade 3 or 4 toxicities|2 years|grade 3 or 4 toxicities|||participants|||Number
2749327|NCT00881621|Secondary|Progression Free Survival|Time of study entry to cancer progression.|24 months|Time of study entry to disease progression.|||months||95% Confidence Interval|Median
2749328|NCT00881621|Secondary|Clinical Benefit Response|"number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors.~Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|3 months||||participants|||Number
2749329|NCT00881621|Primary|Overall Survival|Time of study entry to time of death|24 months||||months||95% Confidence Interval|Median
2749330|NCT00881608|Secondary|Duration of Vaginal Bleeding Following Treatment With Proellex.||At least 2 days|Study prematurely terminated||||||
2749331|NCT00881608|Primary|Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.||An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses|Study prematurely terminated||||||
2749332|NCT00881530|Primary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.|78 weeks plus 1 week of follow-up|Treated set|||percentage of participants|||Number
2749333|NCT00881530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||mg/dL||Standard Deviation|Mean
2749334|NCT00881530|Secondary|Occurrence of a Relative Efficacy Response|Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of participants|||Number
2749335|NCT00881530|Secondary|Occurrence of a Treat-to-target Response (HbA1c < 6.5%)|Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of participants|||Number
2749336|NCT00881530|Secondary|Occurence of a Treat-to-target Response (HbA1c < 7.0%)|Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of participants|||Number
2749337|NCT00881530|Secondary|Change From Baseline in HbA1c Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of HbA1c||Standard Deviation|Mean
2749338|NCT00881530|Primary|Change From Baseline to Week 78 in Lipid Parameters|Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)|Weeks 1 and 78|Treated set|||mmol/L||Standard Deviation|Mean
2749339|NCT00881530|Primary|Hypoglycaemic Events|"Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:~Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)~Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)~Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance~Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions"|78 weeks plus 1 week of follow-up|Treated set|||percentage of participants|||Number
2749341|NCT00881504|Primary|Progression-free Survival|Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.|2 years|"Primary outcome of 4 participants out of 8 was undetermined due to several reasons including patient refusal of further follow up.~Of the 4 patients remaining for analysis, progression free survival of 34, 26.3, 7, and 4.7 weeks was seen."|||weeks||Full Range|Median
2749342|NCT00881465|Secondary|"Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 (Very Much Improved) and 7 (Very Much Worse)."|Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.|within one week after treatment condition was concluded||||participants|||Number
2749343|NCT00881465|Secondary|Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded||||units on a scale||Standard Deviation|Mean
2749344|NCT00881465|Primary|Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index.|Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded||||units on a scale||Standard Deviation|Mean
2749345|NCT00881361|Other Pre-specified|Disease-Free Survival||Up to 10 years|||||||
2749346|NCT00881361|Secondary|Residual Cancer Burden Class|Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The calculated RCB index value can also be categorized as one of four RCB classes. The number of patients classified in the four RCB classes along with the number of patients missing this data by cohort are reported below. RCB of 0 represents a path complete response while increasing levels (I, then II, then III) indicate an increase in the 'amount' of residual disease remaining.|At time of surgery||||participants|||Number
2749347|NCT00881361|Secondary|Pathologic Complete Nodal Response (pCR) Rate|Pathologic complete nodal response (pCR) rate (percentage) wherein a nodal pCR is pathologically node-negative (pN0) on the basis of SLN surgery and ALND. A 95% binomial confidence interval was constructed for the pCR rate.|At the time of surgery|Patients in cN1 and cN2 Cohort who had at least two SLNs excised and went on to complete ALND were included in this analysis.|||percentage of SLN surgery/ALND||95% Confidence Interval|Number
2749348|NCT00881361|Secondary|Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND)|Node status of patients after preoperative chemotherapy, as measured by the total number of positive nodes (SLN+ALND). Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND.|At time of surgery|Patients with post-chemotherapy AUS results were included in this analysis.|||Participants|||Count of Participants
2749349|NCT00881361|Secondary|False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC)|False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy in women with normal AUS and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100.|At the time of surgery||||percentage of false-negative SLN finding||90% Confidence Interval|Number
2749350|NCT00881361|Secondary|False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN2 Breast Cancer [cN2 Cohort]|False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN2 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. An interval estimate of the SLN false negative rate will be constructed using the Duffy-Santner approach.|At time of surgery|Of the cN2 Cohort patients who Started the study (see Participant Flow), only patients with residual nodal disease were included in this analysis.|||percentage of false-negative SLN finding||95% Confidence Interval|Number
2749351|NCT00881361|Primary|False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN1 Breast Cancer [cN1 Cohort]|False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN1 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. A 2-sided Bayesian credible interval (BCI) for the true FNR was constructed.|At time of surgery|Of the cN1 Cohort patients who Started the study (see Participant Flow), only patients with residual nodal disease were included in this analysis.|||percentage of participants||90% Confidence Interval|Number
2749352|NCT00881335|Secondary|Number of Cases With Hospital Visit||up to 28 days||||participants|||Number
2749353|NCT00881335|Primary|FEV1/FVC%, the Ratio of FEV1 to FVC|"indicators of pulmonary function,~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days||||ratios||Standard Deviation|Mean
2749532|NCT00880009|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749354|NCT00881335|Primary|FVC, Forced Vital Capacity|"indicators of pulmonary function, for example, FVC(unit of measurement:Liter)~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days||||L||Standard Deviation|Mean
2749355|NCT00881335|Primary|FEV1, Forced Expiratory Volume at First Second|"indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days||||L||Standard Deviation|Mean
2749356|NCT00881335|Primary|MPEF,Mean Peak Expiratory Flow|indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.|up to 28 days||||L/min||Standard Deviation|Mean
2749357|NCT00881335|Secondary|Number of Cases With Antibiotics Therapy|antibiotics therapy is the indicators of pulmonary infection|up to 28 days||||participants|||Number
2749358|NCT00881335|Primary|Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)||up to 28 days||||participants|||Number
2749359|NCT00881205|Primary|Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population|The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.|After 16 weeks of treatment|Due to low enrollment numbers study did not achieve the anticipated 80% power.|||units on a scale||Standard Deviation|Mean
2749360|NCT00880997|Secondary|Adverse Events||throughout study - upto 17 weeks||||events|||Number
2749361|NCT00880997|Secondary|# of Participants That Completed the Study|Retention|throughout the study - up to 17 weeks||||Participants|||Count of Participants
2749362|NCT00880997|Secondary|Weeks of Abstinence|Percentage of participants achieving 2 or more consecutive weeks of abstinence|throughout the study - up to 17 weeks||||percentage of participants|||Number
2749363|NCT00880997|Primary|Cocaine Negative Urines|cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine|throughout the study - up to 17 weeks||||percentage of cocaine-negative urines|||Number
2749364|NCT00880919|Primary|Sheehan Disability Scale (SDS)|Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment|Change in functional impairment from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749365|NCT00880919|Primary|Young Mania Rating Scale (YMS)|Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms|Change in manic symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749366|NCT00880919|Primary|Symptom Checklist -90-Revised (SCL-90-R)|90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms|Change in psychological problems and symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749367|NCT00880919|Primary|Barratt Impulsiveness Scale (BIS)|30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.|Change in Impulsiveness from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749368|NCT00880919|Primary|Global Assessment of Functioning Scale (GAF)|Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional|Change in Global Assessment of Functioning from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749369|NCT00880919|Primary|Overt Aggression Scale - Modified (OAS-M)|Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.|Change from Baseline Overt Aggression Scale - Modified to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749586|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])||Baseline up to Month 7||||percentage of participants|||Number
2749370|NCT00880919|Primary|Borderline Evaluation of Severity Over Time (BEST)|Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).|Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749371|NCT00880919|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|"Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression."|baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
2749372|NCT00880919|Primary|Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)|This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.|baseline, weekly until week 8|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Deviation|Mean
2749373|NCT00880906|Secondary|Immunological Assessment Into the Etiology of Eosinophilic Esophagitis||60 days|Saved samples were not analyzed due to there being no difference in the primary outcome measure.||||||
2749374|NCT00880906|Primary|Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)|"Dysphagia Scores:~0 = able to eat normal diet / no dysphagia.~= able to swallow some solid foods~= able to swallow only semi solid foods~= able to swallow liquids only~= unable to swallow anything / total dysphagia"|60 days||||Percent Change|||Number
2749375|NCT00880893|Secondary|Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.|28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749376|NCT00880893|Secondary|Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.|28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749377|NCT00880893|Secondary|Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each serotype with the dengue virus strain were assessed using a PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.|28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749378|NCT00880893|Secondary|Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.|28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749411|NCT00880698|Secondary|Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml|Percentage of HIV-1 infected participants with HIV-1 RNA <= 400 copies/ml at last study visit|42 days after third vaccination or last study visit with an HIV-1 RNA measurement|Includes HIV-infected participants 'as-randomized' with an HIV-1 RNA measurement at their last study visit|||Percentage of participants|||Number
2749587|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])||Baseline up to Month 7||||percentage of participants|||Number
2749588|NCT00879814|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Baseline up to Month 7||||percentage of participants|||Number
2749379|NCT00880893|Secondary|Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.|28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749380|NCT00880893|Secondary|Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.|28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749381|NCT00880893|Secondary|GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo|GMTs against each serotype with the dengue virus strain were assessed using a dengue PRNT assay.|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2749382|NCT00880893|Secondary|GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo|GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2749383|NCT00880893|Secondary|GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine|GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2749384|NCT00880893|Secondary|Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749385|NCT00880893|Secondary|Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749386|NCT00880893|Secondary|Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749589|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.|two days||||scores|Participants|Standard Deviation|Mean
2749387|NCT00880893|Secondary|Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749388|NCT00880893|Secondary|Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers >=10 (1/dilution).|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749389|NCT00880893|Secondary|Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)|Full analysis set included participants who received at least 1 dose of CYD dengue vaccine or Placebo, had at least 1 blood sample drawn and valid post-vaccination serology result. Here, ‘overall number of participants analyzed’=participants evaluable for outcome measure and ‘number analyzed’=participants with available data for specified category.|||Percentage of participants|||Number
2749390|NCT00880893|Primary|GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine|GMTs against each dengue virus serotype (parental strains) were assessed using a dengue PRNT assay.|Pre-Injection 1 and 28 days Post-Injection 3|Analysis was performed on Per-Protocol analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2749391|NCT00880893|Primary|Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo|GMTs against each serotype with the parental dengue virus strains were assessed using a dengue PRNT assay.|Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3|Analysis was performed on Per-Protocol analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2749392|NCT00880893|Primary|Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1 and 28 days Post-Injection 3|Analysis was performed on Per-Protocol analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749393|NCT00880893|Primary|Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1 and 28 days Post-Injection 3|Analysis was performed on Per-Protocol analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749394|NCT00880893|Primary|Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).|Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3|Analysis was performed on Per-Protocol (PP) analysis set which included all participants who were vaccinated and had no protocol deviations. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749395|NCT00880893|Primary|Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.|Day 0 up to 14 days post-each injection|Analysis was performed on Safety analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749412|NCT00880698|Secondary|Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination|Number of participants with at least one positive enzyme immuno assay (EIA) rotavirus antigen test, positive fluorescent focal assay, and specific for rotavirus gene 6 which codes for the VP6 protein after each vaccination.|At entry, days 7, 14, 21 and 42 days after first dose, and at days 7 and 21 after the second and third doses|All participants 'as randomized'|||participants|||Number
2749396|NCT00880893|Primary|Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, >=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: >=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: >10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, >=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.|Day 0 up to 14 days post-any and each injection|Analysis was performed on Safety analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2749397|NCT00880763|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2749398|NCT00880763|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2749399|NCT00880763|Secondary|Change From Baseline in HCV RNA in log10 at Week 4|Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||IU/mL in Log10||Standard Deviation|Mean
2749400|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percentage of participants|||Number
2749401|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percentage of participants|||Number
2749402|NCT00880763|Primary|Percentage of Participants Achieving Rapid Viral Response|Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.|Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percentage of participants|||Number
2749403|NCT00880750|Secondary|Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set|||hours||Full Range|Median
2749404|NCT00880750|Secondary|Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set|||ng/ml||Standard Deviation|Mean
2749405|NCT00880750|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set.|||ng*h/ml||Standard Deviation|Mean
2749406|NCT00880750|Secondary|Urinary Phosphate Excretion on Day 4||Continuous collection on Day 4|PD set|||mmol||Standard Error|Least Squares Mean
2749407|NCT00880750|Primary|Urinary Phosphate Excretion 3-Day Average||Continuous collection over 3 days|Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set.|||mmol||Standard Error|Least Squares Mean
2749408|NCT00880698|Secondary|Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study|HIV tests were done at screening, entry and the last study visit after the third vaccination. Any participants classified as HIV-1 uninfected at screening or entry but HIV-1 infected at their last study visit would be classified as acquiring HIV-1 infection during the study|From study entry until at least 42 days after third vaccination|Includes HIV-1 uninfected participants 'as-randomized' with an HIV test at entry and either 2 or 6 weeks after the third vaccination (or after the time point at which they would have received the third vaccination if they did not receive all three doses)|||participants|||Number
2749409|NCT00880698|Secondary|Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-infected participants 'as randomized' with a CD4 count measurement prior to first vaccination and at their last study visit|||cells/mm^3||Standard Deviation|Mean
2749410|NCT00880698|Secondary|Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-1 infected participants 'as-randomized' with a CD4 percent measurement prior to first vaccination and at last study visit|||Percentage of lymphocytes||Standard Deviation|Mean
2749413|NCT00880698|Primary|Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1.|Percentage of participants who experienced >=3-fold increases from prior to the first vaccination to at least 14 days after the third vaccination in Iga, SNA G1, SNA G2, SNA G3, SNA G4 and SNA P1.|Prior to first vaccination and at least 14 days after third vaccination|Only participants in the per-protocol population (received all 3 as-randomized vaccinations within recommended windows) and with measurements prior to the first vaccination and at least 11 days after the third vaccination and whose levels at the entry time point were less than one third of the upper limit of detection of the assay were included.|||Percentage of participants||95% Confidence Interval|Number
2749414|NCT00880698|Primary|Percentage of Participants Developing New Grade >=3 Adverse Events|Percentage of participants developing new grade >=3 adverse events (abnormal laboratory values (hematology and chemistry), signs, symptoms and diagnoses) not present at the time of the first vaccination. Adverse events were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0, December 2004, Clarification August 2009).|From study entry until at least 42 days after third vaccination|Participants classified 'as'randomized'. Includes all follow-up on participants unblinded during the study and found to be on RotaTeq. Follow-up on participants unblinded during the study and found to be on placebo censored at the time of their last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
2749415|NCT00880685|Secondary|Clinical Global Impression Severity Scales (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)||||units on a scale||Standard Deviation|Mean
2749416|NCT00880685|Secondary|Kleptomania Symptom Assessment Scale (K-SAS)|Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)||||units on a scale||Standard Deviation|Mean
2749417|NCT00880685|Primary|Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS)|Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The KM-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)||||units on a scale||Standard Deviation|Mean
2749418|NCT00880620|Secondary|Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score|"Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of Never (better in outcome), (value 0), Occasionally (value 1), Sometimes (value 2), , Often (value 3), and Always (value 4), (worse in outcome). The minimum possible score is 0 and the maximum is 156. The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result."|Baseline and Week 30 (or End of Study)|Subjects who had no postbaseline efficacy assessments (N=4) and those who had early termination assessments >3 days after last dose and no other postbaseline measurements (N=16) were not included in the efficacy analysis. 2 subjects without a baseline measurement, 1 each from 145mg and 390mg arm were also excluded. Randomized 381-4-16-2=359.|||score on a scale||Standard Deviation|Mean
2749419|NCT00880620|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).~Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25"|Week 30|Analysis included all treated subjects with at least one efficacy measurement after dosing. Subjects who had no post-baseline efficacy assessments (N4) and those who had early termination assessments>3 days after last dose and no other post-baseline measurements (N16) were not included in the efficacy analysis set. Randomized (381)-(4+16) = 361.|||units on a scale||Standard Deviation|Mean
2749420|NCT00880607|Secondary|Adverse Opioid Effect: Respiratory Depression|presence of respiratory depression- dichotomous variable|every 4 hours up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||% patients with respiratory depression|||Number
2749421|NCT00880607|Secondary|Adverse Opioid Effect: Pruritus|presence of pruritus- dichotomous variable|every 4 hours up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||percentage of patients with pruritus|||Number
2749422|NCT00880607|Secondary|Adverse Opioid Effect: Emesis|presence of emesis- dichotomous variable|every 4 hours up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||percentage of patients with emesis|||Number
2749423|NCT00880607|Secondary|Adverse Opioid Effect: Nausea|presence of nausea- dichotomous variable|every 4 hours up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||percentage of patients with nausea|||Number
2749530|NCT00880009|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749424|NCT00880607|Secondary|Post-operative Pain Scores|"Post-operative pain scores using Bieri faces scale every 4 hours up to 48 hours. Using Bieri faces pain scale. The faces show how much something can hurt. The happy face with a smile is no pain = 0 to faces showing more and more pain up 10. The space between two faces is scored 1, 3,5,7, or 9. to 10 (worst pain) will be used every 4 hours post-op for up to 48 hours.~*Scores were not collected and/or included for all participants at all time points. If a patient was sleeping, there score was not recorded. If a patient completed the pain scale incorrectly (used an even number or included a range), then the data point was not included."|every 4 hours up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||units on a scale||Standard Error|Mean
2749425|NCT00880607|Secondary|Time Until First PCA Demand Request|At 4-hour intervals for up to 48 hours IV PCA demands.|every 4 hours up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||hours||95% Confidence Interval|Median
2749426|NCT00880607|Primary|Total IV Morphine Consumption up to 48 Hours Post Surgery|Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.|Four hour intervals for up to 48 hours|Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control.|||mg||95% Confidence Interval|Median
2749427|NCT00880581|Secondary|Response Rate After Cycle 2|"Response after a second cycle of treatment was assessed per the Cheson Criteria, as below.~Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease~CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia~Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR."|6 months|Participants with progressive disease (PD) were not re-evaluated.|||participants|||Number
2749428|NCT00880581|Primary|Overall ObjectiveResponse (ORR) Rate|"Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below.~Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease~CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia~Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR."|12 weeks||||participants|||Number
2749429|NCT00880568|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event|This is a measure of the number of participants who experienced any adverse event (AE) while on study.|First dose up to 30 days after last dose (up to 2 years)|All participants on study|||participants|||Number
2749430|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.~AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4."|Cycle 1, Day 3 (Hour 0 through Hour 24)|All participants in the first 28-day cycle|||hr*nmol/L||Standard Deviation|Mean
2749431|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.~AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants in the first cycle of the 28-day dosing schedule|||hr*nmol/L||Standard Deviation|Mean
2749432|NCT00880568|Secondary|Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)|"AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle.~AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants on the 21-day dosing schedule|||hr*nmol/L||Standard Deviation|Mean
2749433|NCT00880568|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.|Cycle 1 (up to 21 or 28 days, depending on treatment arm)|All participants in the first cycle of each dosing schedule (21 or 28 days)|||participants|||Number
2749434|NCT00880555|Primary|FCI Score at Follow-up|At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.|Year 1, Year 2, Year 3|Individuals completing at least one assessment following baseline|||points awarded for correct items||Standard Deviation|Mean
2749435|NCT00880542|Secondary|Local and Distant Recurrence-free Survival||conclusion of study|Due to study closing early and the few number of participants enrolled, the outcome measures were not done.||||||
2749492|NCT00880191|Secondary|Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.|The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 1 through 6||||percentage of participants|||Number
2749436|NCT00880542|Primary|Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.|After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.|Participants were followed for duration of study, an average of 1 year.|Due to the study closing early and the few number of participants enrolled, the outcome measures were not done.||||||
2749437|NCT00880425|Secondary|Number of Patient With Daily Headache Who Have Non-continuous Headache|Number of patient with Daily Headache who have non-continuous headache|Records were reviewed from April 2009 through June 2009||||participants|||Number
2749438|NCT00880425|Primary|Number of Subjects With Daily Headache Who Have Continuous Headache|The number of subjects with Daily Headache who have continuous headache|Records were reviewed from April 2009 through June 2009||||participants|||Number
2749439|NCT00880399|Secondary|Change From Baseline in the MSFQ Total Score-Females|The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following four areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; and (4) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 4 to 24, where 5 represents greater than normal functioning and 24 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome.|Baseline (Day 1) to Week 6|Only females from all subjects population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749440|NCT00880399|Secondary|Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ)-Males|The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; (4) erectile dysfunction (males only) and (5) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 5 to 30, where 5 represents greater than normal functioning and 30 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome.|Baseline (Day 1) to Week 6|Only males from all subjects population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749441|NCT00880399|Secondary|Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)|The discontinuation signs and symptoms scale consists of 43 signs and symptoms, scored as 'new symptom', 'old symptom but worse', 'old symptom but improved' or ' symptom not present/old symptom but unchanged'. A frequency table for each symptom is reported by treatment and visit. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms are calculated for treatment and visit and reported.|Week 1 to Week 8/Follow up 1|All subjects population comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Signs and symptoms||Standard Deviation|Mean
2749442|NCT00880399|Secondary|Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS)|The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions.|Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2749443|NCT00880399|Secondary|Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items|A HAM-D remitter was defined as a participant with a HAM-D total score less than or equal to 7. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2749486|NCT00880230|Secondary|Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)|The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.|30 Days|Intent to Treat Population (ITT)|||Percentage of Patients|||Number
2749444|NCT00880399|Secondary|Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS)|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The score relating to SQ and RVS was measured by items/questions 4 and 5 respectively of the MSQ. The following two variables SQ and RVS were assessed in order to determine effects on sleep. Participants were asked to rate their SQ and RVS on a scale of 1 to 10. This scale has no subscales. The total score for SQ and RVS, both, ranged from 1 to 10 where 1=poor and 10=excellent. Lower scores indicated poor SQ and RVS and higher scores indicated excellent SQ and excellent RVS. During the conduct of study, participants self-administered MSQ via an IVRS from their home the morning of each clinic visit. If a participant did not remember to place IVRS MSQ call the morning of the clinic visit from home, they were allowed to place call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749445|NCT00880399|Secondary|Change From Baseline in MSQ Values for Number of Nocturnal Awakenings|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Awakenings||Standard Error|Least Squares Mean
2749446|NCT00880399|Secondary|Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO)|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Minutes (mins)||Standard Error|Least Squares Mean
2749447|NCT00880399|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score|The CPFQ is a brief self-report scale which is designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The scale comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question is rated on a scale of 1 to 6, (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas were included: motivation/interest/enthusiasm; wakefulness/alertness; energy; focus/sustain attention; remember/recall information; find words and sharpness/mental acuity. The total score (sum of individual question scores) ranged from 7 to 42. Lower score 7 represents greater than normal functioning and higher score 42 indicate poorer functioning (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749448|NCT00880399|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. For the CGI-S, an independent site rater assessed the participant's severity of illness considering (1) their total clinical experience with the particular population being studied and (2) information obtained during the Baseline HAM-D interview with the participant. The severity of illness (CGI-S) item is rated on a 1 to 7 scale such that 1 (normal, not at all ill) and 7 (among the most extremely ill). Higher scores indicate worsening. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749449|NCT00880399|Secondary|Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved)|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. Global improvement (CGI-I) item is rated on a 1-7 scale. The CGI-I assessed scores range from 1 - very much improved to 7 - very much worse. For the CGI-I, the investigator or delegated qualified clinician indicated their assessment of the participant's total improvement or worsening compared with the individual's condition at the start of the study whether or not the change was judged to be due to drug treatment. A participant with a CGI-I score of 1 'very much improved' or 2 'much improved' was considered a responder. Percentage of responders are reported.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2749487|NCT00880230|Primary|Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.|The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.|In-hospital and 9 Months|Intent to Treat Population (ITT)|||Percentage of Participants|||Number
2749450|NCT00880399|Secondary|Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)|The HAMD anxiety factor score includes 6 items/questions (item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, item 13: somatic symptoms general, item 15: hypochondriasis and item 17: insight). The items are rated on a scale of 0 to 4 (items 10, 11 and 15) or 0 to 2 (items 12, 13 and 17), higher scores reflecting greater severity. The highest possible score is 18, which represents the most severe measure of anxiety; the lowest possible score is 0, which represents an absence of anxiety. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749451|NCT00880399|Secondary|Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score|The QIDS-SR is a self-report rating scale that assesses symptom severity of major depressive disorders. The QIDS-SR utilized during this study contained 16 separate items which correspond to 9 symptom criterion domains: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation,(5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation. The QIDS-SR total score was calculated using the sum of the domain scores. The highest possible total QIDS-SR score is 27, which represents the most severe measure of depression. The lowest possible score is 0, which represents an absence of depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749452|NCT00880399|Secondary|Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale)|The Bech Melancholia is sum of scores on 6 items/questions (item 1: depressed mood, item 2: feelings of guilt, item 7: work and activities, item 8: retardation, item 10: anxiety psychic and item 13: somatic symptoms general) pertaining to melancholia within HAM-D. The items are rated on a scale of 0 to 4 (items 1, 2, 7, 8 and 10) or 0 to 2 (item 13), higher scores reflecting greater severity. The highest possible score is 24, which represents the most severe measure of melancholy; the lowest possible score is 0, which represents an absence of melancholy. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749453|NCT00880399|Secondary|Number of Participants With (Maintained) Clinical Response|Clinical response or antidepressant response was defined as >= 50% reduction from randomization in their HAMD total score, where this response was maintained until the end of the Treatment Phase (Week 6). Participants who met the >= 50% reduction at Week 6 without also having met it at Week 4 were not considered to have reached a maintained response, and therefore were censored at Week 6. Number of participants with maintained clinical response are reported.|Up to Week 6|ITT Population.|||Participants|||Number
2749454|NCT00880399|Secondary|Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score|Participants who had 50% or greater reduction from Baseline in their total HAMD score were termed as responders. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. Baseline was Day 1.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2749455|NCT00880399|Primary|Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score|The HAM-D is designed to measure severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items (1: depressed mood, 2: feelings of guilt, 3: suicide, insomnia early, 4: insomnia early, 5: insomnia middle, 6: insomnia late, 7: work and activities, 8: retardation, 9: agitation, 10: anxiety psychic item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, 13: somatic symptoms general, 14: genital symptoms, 15: hypochondriasis, 16: loss of weight and 17: insight) that are ranked on a scale of 0 to 4 or 0 to 2 (4 and 2: highly severe and 0: not present). The HAM-D total score is calculated by summing individual response scores on the HAM-D questionnaire. The highest possible score is 52, representing most severe measure of depression; lowest possible score is 0, representing no depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|The Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2749456|NCT00880360|Secondary|Toxicity|Determine any toxicity associated with Ontak treatment in these patients.|3 years|N/A data were not collected||||||
2749457|NCT00880360|Primary|Number of Participants Demonstrating Clinical Response|Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.|2 years|Measurements performed by RECIST criteria and response reported as a percent. 56 subjects needed to be recruited to the study to determine efficacy. Analysis was on an intent to treat basis.|||participants|||Number
2749488|NCT00880191|Secondary|Comparison of Daily Complete Response Endpoints|Daily complete response is defined as no emetic episodes and no use of rescue therapy.|Days 1 through 6||||percentage of participants|||Number
2749493|NCT00880191|Secondary|Complete Response|The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.|Days 2-6||||percentage of participants|||Number
2749458|NCT00880334|Post-Hoc|Disease Control Rate|Disease control rate is defined as the percentage of participants with confirmed overall Stable Disease (SD) or better using RECIST 1.0 criteria which parallels absence of disease progression (PD) on treatment during the randomized phase. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients without measurable disease only at baseline are included, based on status of non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).||||percentage of participants||95% Confidence Interval|Number
2749459|NCT00880334|Secondary|Objective Response Rate|Objective response rate is defined as the percentage of participants who achieved a confirmed overall partial response (PR) or complete response (CR) using RECIST criteria on treatment during the randomized phase. Patients without measurable disease only at baseline are included, based on status of non-target lesions.Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.|||percentage of participants||95% Confidence Interval|Number
2749460|NCT00880334|Secondary|Median Overall Survival|Overall survival is defined from date of randomization to date of death or censored at the date the patient was last known alive.|Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).|The analysis dataset is comprised of all eligible and treated patients.|||months||95% Confidence Interval|Median
2749461|NCT00880334|Secondary|Grade 3-5 Toxicity Rate|Grade 3-5 toxicity rate is the percentage of participants experiencing maximum grade of all toxicity types of grade 3-5 with any attribution on treatment during the randomized phase.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.|||percentage of participants||95% Confidence Interval|Number
2749462|NCT00880334|Primary|Median Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).|The analysis dataset is comprised of all eligible and treated patients.|||months||95% Confidence Interval|Median
2749463|NCT00880269|Secondary|Overall Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
2749464|NCT00880269|Secondary|Event-free Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
2749465|NCT00880269|Secondary|Duration of Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
2749466|NCT00880269|Secondary|Time to Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
2749467|NCT00880269|Secondary|Partial Response Measured in Stratum A and B|As predefined in the study's protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi)|6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
2749468|NCT00880269|Primary|Best Response as Per Investigator Assessment by Stratum (FAS)|Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simon's optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B.|6 cycles of treatment with a 28-day treatment cycle (Day 168)|Full analysis set (FAS) is the same as the Safety set and includes all patients who received at least one dose of study drug. The FAS was used for final efficacy analyses.|||Percentage of Participants|||Number
2749489|NCT00880191|Secondary|Level of Satisfaction for the Control of Nausea.|Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)|Days 1 through 6|203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint.|||units on a scale||Standard Deviation|Mean
2749469|NCT00880256|Secondary|Irritable Bowel Syndrome (IBS) Quality of Life|The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).|6 months|All participants who completed at 6 months were included|||units on a scale||Standard Deviation|Mean
2749470|NCT00880256|Primary|IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)|The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.|6 months|We compared scores at baseline, 2-month, and 6-month time points, using t-tests. A two-sided P value of less than 0.05 was considered statistically significant. The standardized mean difference (Cohen’s d effect size) from baseline to 2-months, and baseline to 6-months was calculated for each variable.|||units on a scale||Standard Deviation|Mean
2749471|NCT00880230|Secondary|Target Limb Loss|Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749472|NCT00880230|Secondary|Death|Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749473|NCT00880230|Secondary|Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months||||Percentage of Patients|||Number
2749474|NCT00880230|Secondary|Target Limb Revascularization|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749475|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749476|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.|9 Months|Intention to Treat (ITT)|||Percentage of Patients|||Number
2749477|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.|9 Months|Intention to Treat (ITT)|||Percentage of Patients|||Number
2749478|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.|6 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749479|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.|6 Months|Intention to Treat (ITT)|||Percentage of Patients|||Number
2749480|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.|6 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749481|NCT00880230|Secondary|Clinical Success|Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|9 Months|Intent to Treat Population (ITT)|||Percentage of Patients|||Number
2749482|NCT00880230|Secondary|Clinical Success|Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|6 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749483|NCT00880230|Secondary|Clinical Success|Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.|30 Days|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749484|NCT00880230|Secondary|Procedural Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).|Up to the moment the catheter sheath introducer has been removed|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
2749485|NCT00880230|Secondary|Device Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.|At time of deployment|Intent to Treat Population (ITT)|||Percentage of Patients|||Number
2749490|NCT00880191|Secondary|Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses|The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.|Days 1 through 6||||units on a scale||Standard Deviation|Mean
2749495|NCT00880165|Secondary|Continuous Positive Airway Pressure Adherence|Mean daily hours of use of continuous positive airway pressure over the 3 month intervention|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.|||hours per day||Standard Deviation|Mean
2749496|NCT00880165|Secondary|Functional Outcome of Sleep Questionnaire|Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.|||units on a scale||Standard Deviation|Mean
2749497|NCT00880165|Primary|Cost|VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.|Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.|||dollars|||Number
2749498|NCT00880100|Post-Hoc|Percentage of Patients With Control of Steatorrhea Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. There was no imputation of missing data. Here n signifies patients who were evaluable for each specific category."|||percentage of patients||95% Confidence Interval|Number
2749499|NCT00880100|Other Pre-specified|Percentage of Days With Abdominal Pain and Excessive Flatulence|Mean percentage of days with abdominal complaints during baseline phase (BP) and the 5-day collection period of the treatment phase for total patients was summarized. Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days abdominal pain (AP) and excessive flatulence (EF) in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specific category."|||percentage of days||Standard Deviation|Mean
2749500|NCT00880100|Other Pre-specified|Total Weight of Stools|The total weight of stools in grams (g) is the total weight obtained during the stool collection period regardless of the number of stools that had been collected during this same collection period. Mean total weight of stools in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here N (number of patients analyzed) represents number of patients who were evaluable for this outcome measure. Here n signifies patients who were evaluable for each specified category."|||gram (g)||Standard Deviation|Mean
2749501|NCT00880100|Secondary|Mean Number of Days Without Abdominal Complaints|Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days without abdominal complaints in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||days||Standard Deviation|Mean
2749502|NCT00880100|Secondary|Percentage of Stools With Abnormal Characteristics|Stools of abnormal characteristics were defined as bulky/large, foul-smelling and/or oily stools. Mean percentage of stools with abnormal characteristics in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||percentage of stools||Standard Deviation|Mean
2749513|NCT00880048|Secondary|Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)|The DESS scale consisted of 43 signs and symptoms, scored as 'new symptom', 'old symptom but worse', 'old symptom but improved' or 'symptom not present/old symptom but unchanged'. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms were calculated for each treatment and visit. n = number of subjects who had at least one of the 43 symptoms in the specified category. The summary for a specified category are of the number of symptoms the n subjects had in that category. Treatment period was up to Week 6.|Up to 17 days post-treatment|All subjects Population. Only those participants available at the specified time points were analyzed.|||Number of Incidences||Standard Deviation|Mean
2749503|NCT00880100|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as hard and formed or soft and formed consistency. Abnormal consistency was defined as loose and unformed stool or liquid stools and diarrhea. Percentage of stools with normal consistency of each patient was calculated from normal consistency of stools by the patient per day. Mean percentage of stools with normal consistency in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||percentage of stools||Standard Deviation|Mean
2749504|NCT00880100|Secondary|Percentage of Patients With Normal Stool Frequency|Normal stool frequency was defined as having less than 4 bowel movements per day in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the Treatment Phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||percentage of patients||95% Confidence Interval|Number
2749505|NCT00880100|Primary|Percentage of Patients With Control of Steatorrhea|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected at baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and during the 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|The Intent-to-treat (ITT) population included all patients who signed an informed consent form (ICF) and started the baseline phase. The 50th percentile imputation method was used for missing data.|||percentage of patients||95% Confidence Interval|Number
2749506|NCT00880087|Other Pre-specified|Neurological Abnormality Scores (for Participants Who Survive)||Measured at Month 12|||||||
2749507|NCT00880087|Secondary|Neuropsychological Scores (for Participants Who Survive)|Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.|Measured at Month 12|Randomized children alive at one year with neuropsychological score available.|||Participants|||Count of Participants
2749508|NCT00880087|Secondary|Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest|Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome. Since higher levels of VABS-II represent a better outcome, a larger decline (large negative magnitude of change) in VABS-II score from baseline to one year represents a worse outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)|||Participants|||Count of Participants
2749509|NCT00880087|Secondary|Survival|Survival at one year after cardiac arrest|Measured at one-year anniversary of cardiac arrest.|All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.|||Participants|||Count of Participants
2749510|NCT00880087|Primary|Survival With Good Neurobehavioral Outcome|Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest. Higher values of VABS-II represent a better outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|Subjects with baseline VABS-II >= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.|||Participants|||Count of Participants
2749511|NCT00880048|Secondary|Change From Baseline in the MSFQ Total Score in Females|MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.|Baseline and up to Week 6|All Subject Population (female). Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2749512|NCT00880048|Secondary|Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males|MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.|Baseline and up to Week 6|All subjects Population (males). Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749514|NCT00880048|Secondary|Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)|Assessment of suicidality were done through use of the CSSRS for suicidal ideation and suicidal behavior. For suicidal ideation ratings were 1 to 5, where 1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation without intent to act, 4. Active suicidal ideation with any methods (not plan) without intent to act, 5. Active suicidal ideation with specific plan and intent and for suicidal behavior ratings were 6 to 12, Where 6. Actual attempt, 7. Engaged in non-suicidal self-injurious behavior, 8. Interrupted attempt, 9. Aborted attempt, 10. Preparatory acts or behavior, 11. Suicidal behavior, 12. Completed suicide. n= number participants with at least one CSSRS assessment after the first dose of study medication (i.e. on treatment or post treatment). Only those categories from CSSRS (1-12) are presented for which symptoms were actually observed in the participants. Categories with null values for all the arms have not been presented.|Up to 17 days post-treatment|The All Subjects Population was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2749515|NCT00880048|Secondary|Number of HAM-D Remitters|A HAMD remitter was defined as a participant who had a HAMD Total Score <=7. The HAMD total score was calculated for each participant at each time point. Those participants with no missing value for HAMD total score were categorized as having a HAMD total score of <=7 or >7.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2749516|NCT00880048|Secondary|Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749517|NCT00880048|Secondary|Change From Baseline in the MSQ Number of Nocturnal Awakenings|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and upto Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Number of awakenings||Standard Error|Least Squares Mean
2749518|NCT00880048|Secondary|Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||minutes (min)||Standard Error|Least Squares Mean
2749519|NCT00880048|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score|CPFQ was a brief self-report scale which was designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprised of 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1 indicating greater than normal functioning, 2, indicating normal functioning, and with higher numbers indicating poorer functioning. Two versions of the CPFQ were utilized during the study. The Baseline CPFQ requested the participant reflect back over the past month. For the treatment period, the CPFQ requested the participant reflect back over the past week. Value at randomization was the Baseline value. Change from Baseline in Total Score was the difference between CPFQ Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749520|NCT00880048|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S assessed scores range from 1 - Very much Improved to 7 - Very much worse, with 0 representing a participant that was not assessed. For the CGI-S, remote, blinded MedAvante, raters assessed the participant's severity of illness considering their total clinical experience with the particular population being studied and information obtained during the Baseline HAMD interview with the participant. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between CGI-S Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749528|NCT00880022|Secondary|Symptom Improvement|Lymphedema Symptom and Intensity Scale-Arm measures 30 symptoms yes no over the past 7 days . Total yes items added for number of symptoms.|Before first treatment and end of all treatments|Number of participant symptoms|||Number of participant symptoms||Inter-Quartile Range|Median
2749521|NCT00880048|Secondary|Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score|The CGI-I assessed scores range from 1 - Very much Improved to 7 - Very much worse, with 0 representing a participant that was not assessed. The assessed scores were dichotomized. Scores of 1 or 2 was in the first category, scoring 1. All other scores (except zero which was regarded as missing) was in the second category, scoring 0. The percentage of participants in the first category was calculated for each assessment.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2749522|NCT00880048|Secondary|Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)|The anxiety score was extracted from the HAM-D-17 and comprises of items 10, 11, 12, 13 and 15 from the HAM-D scale. The anxiety score was calculated by summing the individual response scores to these questions. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 18 (most severe measure of depression). Due to the small number of items, missing data was not imputed for the anxiety score. If either of the anxiety items was missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in anxiety score was the difference between the anxiety score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749523|NCT00880048|Secondary|Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score|QIDS-SR assessed symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It consisted of 16 separate items, defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The lowest possible score was 0, which represented an absence of depression; the highest possible score was 27, which represented the most severe measure of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. If any of the 9 domains above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between QIDS total score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749524|NCT00880048|Secondary|Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)|The BECH scale was extracted from the HAMD-17 and comprised the 6 items (sum of items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D scale): Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic and Somatic Symptoms General. The BECH Total Score was calculated by summing the individual response scores. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 22 (most severe measure of depression). Due to the small number of items , missing data was not imputed for the BECH Total Score. If any of the 6 items above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in BECH Total Score was the difference between BECH Total Score at the time point being analyzed to randomization.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749525|NCT00880048|Secondary|Number of Participants Who Maintained Clinical Response by Week 6|"The start of the 'maintained antidepressant response' was the time at which a participant demonstrates a 50% reduction from randomization in their HAM-D total score and where this response was maintained until the end of the treatment phase (week 6). Participants who met the 50% reduction at week 6 without having met it at week 4 were considered to have reached a maintained response, and therefore were censored at week 6. Where a participant met the criteria for maintained antidepressant response, the time (in days) to maintained antidepressant response was calculated as: (Date of assessment at which the maintained response commences minus Date of randomization) plus 1. Where a participant did not met the criteria for maintained antidepressant response, their time to response was censored at the last on-treatment assessment they undertake, up to and including the week 6 assessment."|Up to Week 6|ITT Population.|||Participants|||Number
2749526|NCT00880048|Secondary|Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score|"HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The HAM-D Total Score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was carried forward and used in the calculation of the change from randomization value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Data was presented as percent of HAM-D responders which was defined as participants who has a >=50% reduction from randomization in HAM-D total score."|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2749527|NCT00880048|Primary|Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score|"HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. Items with quantifiable severity were scored 0 (lowest severity) to 4 (greatest severity); The HAM-D total score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was carried forward and used in the calculation of the change from randomization (Baseline) value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Change from Baseline in total score was the difference between HAM-D total score at the time point being analyzed and randomization."|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2749533|NCT00880009|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749534|NCT00880009|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749535|NCT00880009|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 36 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749536|NCT00880009|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749537|NCT00880009|Secondary|Progression-Free Survival (PFS) Based on Investigator|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death). PFS assessed by investigator was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749538|NCT00880009|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after the last dose|Safety population included all participants who receive at least 1 dose of study treatment.|||percentage of participants|||Number
2749539|NCT00880009|Primary|Progression-Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PFS assessed by independent radiologist was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2749540|NCT00879996|Secondary|Self-reported Illicit Opioid Use||6 months||||number of participants|||Number
2749541|NCT00879996|Secondary|Numerical Rating Score for Functioning|We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.|6 months|The participants who completed the treatment were included in the statistical analysis.|||units on a 0-10 point NRS scale||Standard Deviation|Mean
2749542|NCT00879996|Secondary|Numerical Rating Score for Pain|Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.|6 months|Participants that completed the treatment at 6 months were analyzed.|||units on a 0-10 NRS scale||Standard Deviation|Mean
2749543|NCT00879996|Primary|Number of Participants Retained in Treatment|This outcome assesses the number of participants who completed the treatment after 6 months.|6 months|All participants that were randomized were analyzed regarding their retention in treatment at 6 months.|||participants|||Number
2749544|NCT00879970|Secondary|Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)|CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
2749628|NCT00879619|Secondary|Survival|Quantitative Kaplan-Meyer estimates of progression-free survival and overall survival will be determined.|At 2 and 3 years|||||||
2749545|NCT00879970|Secondary|Mean Score on Euro-QoL (EQ)-5D|"Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from 0 to 1, whereby a score of 1 represents the best health state imaginable and 0 represents a health state equivalent to being dead. Negative states are those worse than being dead."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
2749546|NCT00879970|Secondary|Number of Participants With Erectile Dysfunction|Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
2749547|NCT00879970|Secondary|Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit|CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
2749548|NCT00879970|Secondary|Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests|"Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. Liver function test abnormal and hepatic enzyme increased were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749549|NCT00879970|Secondary|Number of Participants With a Fracture|Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749550|NCT00879970|Secondary|Number of Participants With Clinical Proteinuria|Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749551|NCT00879970|Secondary|Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)|Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749552|NCT00879970|Secondary|Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy|Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749553|NCT00879970|Secondary|Number of Participants With Composite Microvascular Outcome|The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749554|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina|CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749555|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Any Reason|Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749556|NCT00879970|Secondary|Number of Participants With Any Revascularization|Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749557|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D|An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
2749558|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)|An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).|From Randomization at Visit 3 up to the Final Visit (average of 162 days)|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
2749559|NCT00879879|Secondary|6-minute Walk Test Results||1 year|||||||
2749560|NCT00879879|Secondary|Baseline/Transition Dyspnea Index||1 year|||||||
2749561|NCT00879879|Secondary|Total Lung Capacity by Plethysmography||1 year|||||||
2749562|NCT00879879|Secondary|Diffusion Capacity of Carbon Monoxide (DLCO)||1 year|||||||
2749563|NCT00879879|Primary|Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year|"Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline.~Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment."|1 year||||participants|||Number
2749564|NCT00879814|Secondary|Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)||Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3||||titers||95% Confidence Interval|Geometric Mean
2749565|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).||Baseline up to Month 7||||percentage of participants|||Number
2749566|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).||Baseline up to Month 7||||percentage of participants|||Number
2749567|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).||Baseline up to Month 7||||percentage of participants|||Number
2749568|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).||Baseline up to Month 7||||percentage of participants|||Number
2749569|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).||Baseline up to Month 7||||percentage of participants|||Number
2749570|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).||Baseline up to Month 7||||percentage of participants|||Number
2749571|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).||Baseline up to Month 7||||percentage of participants|||Number
2749572|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)||Baseline up to Month 7||||percentage of participants|||Number
2749573|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)||Baseline up to Month 7||||percentage of participants|||Number
2749574|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)||Baseline up to Month 7||||percentage of participants|||Number
2749575|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)||Baseline up to Month 7||||percentage of participants|||Number
2749576|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])||Baseline up to Month 7||||percentage of participants|||Number
2749577|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)||Baseline up to Month 7||||percentage of participants|||Number
2749578|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)||Baseline up to Month 7||||percentage of participants|||Number
2749579|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])||Baseline up to Month 7||||percentage of participants|||Number
2749580|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])||Baseline up to Month 7||||percentage of participants|||Number
2749581|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])||Baseline up to Month 7||||percentage of participants|||Number
2749582|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)||Baseline up to Month 7||||percentage of participants|||Number
2749583|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])||Baseline up to Month 7||||percentage of participants|||Number
2749584|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)||Baseline up to Month 7||||percentage of participants|||Number
2749585|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)||Baseline up to Month 7||||percentage of participants|||Number
2749590|NCT00879775|Secondary|Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
2749591|NCT00879775|Secondary|Health-related Quality of Life|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
2749592|NCT00879775|Secondary|Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
2749593|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
2749594|NCT00879710|Secondary|Changes in Cholesterol Absorption or Synthesis Rates From the Baseline|We did not complete analyses of this outcome as we ran out of funds to measure these variables though samples have been collected.|6 weeks after initiation of drug therapy|||||||
2749595|NCT00879710|Primary|Changes in LDL Cholesterol|"Subjects with T1DM or T2DM were assigned to alternating therapy with simvastatin (40 mg) or ezetimibe (10 mg) for 6 weeks in a crossover design.~The data are reported as follows.~Subjects with type 1 diabetes mellitus:~Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)~Subjects with type 2 diabetes mellitus:~Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)"|6 weeks after starting drug therapy||||mmol/L||Standard Error|Mean
2749596|NCT00879697|Primary|Total Walking Distance|The maximal walking distance|12 weeks||||meter||Standard Deviation|Mean
2749597|NCT00879684|Secondary|Number of Participants With Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.|Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)|Safety population included all enrolled participants in the study who received any study medication.|||participants|||Number
2749598|NCT00879684|Secondary|Number of Samples From Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||samples|Participants||Number
2749599|NCT00879684|Secondary|Number of Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||participants|||Number
2749600|NCT00879684|Secondary|Recommended Phase 2 Dose (RP2D): Stage 1|RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.|Baseline (Day 0) up to 42 days after the last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.|||(mg/kg)/week|||Number
2749601|NCT00879684|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||hours||Full Range|Median
2749602|NCT00879684|Secondary|Apparent Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||(mL/hr)/kg||Standard Deviation|Geometric Mean
2749603|NCT00879684|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||milliliter per kilogram (mL/kg)||Standard Deviation|Geometric Mean
2749604|NCT00879684|Secondary|Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]|AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2749605|NCT00879684|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||hours||Standard Deviation|Mean
2749606|NCT00879684|Secondary|Maximum Observed Serum Concentration (Cmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2749607|NCT00879684|Primary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline (Day 0) up to 30 days after last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.|||participants|||Number
2749608|NCT00879658|Secondary|Geometric Mean BAF312 Plasma Trough Concentrations|Geometric mean BAF312 plasma concentrations by treatment and by visit|Month 1, Month 3, Month 6|The PK Analysis Set consisted of all patients who received at least one dose of active BAF 312 study medication. Patients were analyzed according to the treatment received.|||ng/ml||Standard Deviation|Mean
2749609|NCT00879658|Secondary|Number of CUAL - Period 1|Combined unique active lesions (CUAL) are defined as new Gd-enhanced T1 lesions or new or enlarging T2 lesions, withput double counting of lesions at any specific point in time.|6 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||lesions||Standard Deviation|Mean
2749610|NCT00879658|Secondary|Number of Monthly New Gd-enhanced T1 Lesions With High Baseline Disease Activity - Period 1 Only at 6 Months|"In patients with high baseline disease activity, the relative reduction in new Gd-enhanced T1 lesions compared to placebo at Month 6. High baseline disease activity is defined as >=2 Gd-enhanced T1 lesions at baseline.~The number of lesions of each type was available from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|6 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesions||Standard Deviation|Mean
2749611|NCT00879658|Secondary|Number of Monthly New Gd-enhanced T1 Lesions With High Baseline Disease Activity - Period 1 +2 at 3 Months|"In patients with high baseline disease activity, the relative reduction in new Gd-enhanced T1 lesions compared to placebo at Month 3.~High baseline disease activity is defined as >=2 Gd-enhanced T1 lesions at baseline.~The number of lesions of each type was available as such from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|3 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesions||Standard Deviation|Mean
2749612|NCT00879658|Secondary|Number of Patients Without Any New MRI Disease Activity - Period 1 Only|The proportion of patients who were free of new Gd-enhanced T1 lesions, and/or free of new or enlarging T2 lesions, i.e. free of new MRI activity (CUAL).|6 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Participants|||Count of Participants
2749613|NCT00879658|Secondary|Number of Patients Without Any New MRI Disease Activity - Period 1 +2|The proportion of patients who were free of new Gd-enhanced T1 lesions, and/or free of new or enlarging T2 lesions, i.e. free of new MRI activity (CUAL).|3 months|Full analysis set|||Participants|||Count of Participants
2749614|NCT00879658|Secondary|Number of Monthly New/Enlarging T2 Lesions - Period 1 Only at 6 Months|"Month 4 through Month 6 inclusive include patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.~The number of lesions of each type was available from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|6 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesions||Standard Deviation|Mean
2749615|NCT00879658|Secondary|Number of Monthly New/Enlarging T2 Lesions - Period 1 +2 at 3 Months|"The results for Month 1 through Month 3 inclusive include patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.~The number of lesions of each type was available from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|3 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesions||Standard Deviation|Mean
2749616|NCT00879658|Secondary|Number of All Gd-enhanced T1 Lesions - Period 1 Only at 6 Months|"The results for Month 4 through Month 6 inclusive includes patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.~The number of lesions of each type was available from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|6 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesions||Standard Deviation|Mean
2749617|NCT00879658|Secondary|Number of All New Gd-enhanced T1 Lesions - Period 1 +2 at Month 3|"The results for Month 1 through Month 3 includes patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.~The number of lesions of each type was available from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|3 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesions||Standard Deviation|Mean
2749618|NCT00879658|Secondary|Number of New [Gd]-Enhanced T1 Lesions Monthly - Period 1 Only at 6 Months|"Month 4 through Month 6 include patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.~The number of lesions of each type was available from the central MRI reader. No derivation was performed.~Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link."|6 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||lesions||Standard Deviation|Mean
2749619|NCT00879658|Secondary|Number of New [Gd]-Enhanced T1 Lesions Monthly - Period 1 +2 at Month 3|Results for Month 1 through Month 3 inclusive include patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan. The number of lesions of each type was available from the central MRI reader. No derivation was performed. Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new [Gd]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.|3 months|Full analysis set One patient in the placebo group was misrandomized and never received study medication.|||Lesion||Standard Deviation|Mean
2749620|NCT00879658|Secondary|Proportion of Participants With Relapse-free Patients - Period 1 Only|To explore the effect of BAF312 on the proportion of relapse-free patients (confirmed relapses only)|6 months|Full analysis set - Period I One patient in the placebo group was misrandomized and never received study medication.|||proportion of participants|||Number
2749621|NCT00879658|Secondary|Proportion of Participants With Relapse-free Patients - Period 1 + 2|To explore the effect of BAF312 on the proportion of relapse-free patients (confirmed relapses only)|3 month|Full analysis set - Period I and II|||Proportion of participants|||Number
2749622|NCT00879658|Secondary|Number of Confirmed Relapses - Period 1|confirmed relapse: A relapse was to be confirmed by the Independent Evaluating Physician (examining neurologist) performing the EDSS. It was recommended that this occurred within 7 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the Expanded Disability Status Scale (EDSS) or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).|6 months|Full analysis set in period I|||Confirmed relapses|||Number
2749623|NCT00879658|Primary|Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL)|"Combined unique active lesions (CUAL) were defined as new gadolinium [Gd]-enhanced lesions on T1-weighted MRI scans or new or enlarging lesions on T2-weighted MRI scans, without double-counting of lesions.~ED50 is the dose that gives half of the asymptotic maximum change over placebo. ED90 is the dose that gives 90% of the asymptotic maximum change over placebo."|3 months of treatment|Full analysis set (FAS) consisted of all patients who received at least one dose of study medication and had no protocol deviation with severity code 0 or 8. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mg||95% Confidence Interval|Number
2749624|NCT00879645|Primary|Sodium Sulfide in Blood|Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.|8 hours after treatment||||ng/mL||Standard Deviation|Mean
2749625|NCT00879645|Primary|Thiosulfate in Urine|Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection|48 hours after treatment||||ng/mL||Standard Deviation|Mean
2749626|NCT00879645|Primary|Thiosulfate in Plasma|Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.|8 hours after treatment||||ng/mL||Standard Deviation|Mean
2749627|NCT00879619|Secondary|Qualitative and Quantitative Toxicity|Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Categorical analysis of toxicities will be performed.|Every 3 weeks and at study termination|||||||
2749629|NCT00879619|Secondary|Time to Progression (TTP) by PSA Response and Disease Response|Defined as an absolute increase in PSA of at least 2 ng/ml. For subjects with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years|||||||
2749630|NCT00879619|Secondary|Duration of Response (DR)|Response rates will be expressed with two-sided exact binomial confidence intervals.|Up to 3 years|||||||
2749631|NCT00879619|Secondary|Rates of Tumor Response (ORR)|Response rates will be expressed with two-sided exact binomial confidence intervals. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.|Every 2 months|||||||
2749632|NCT00879619|Primary|Prostate Specific Antigen (PSA) Response Rate|Defined by >= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years|||||||
2749633|NCT00879411|Secondary|Overall Tolerability Scale|Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10|8 weeks||||units on a scale||Standard Deviation|Mean
2749634|NCT00879411|Primary|Efficacy (Change of Diastolic Blood Pressure)|Change from baseline in 24h diastolic blood pressure (BP) at week 8|baseline to 8 weeks||||mm Hg||Standard Deviation|Mean
2749635|NCT00879411|Primary|Efficacy (Change of Systolic Blood Pressure)|Change from baseline in 24h systolic blood pressure (BP) at week 8|baseline to 8 weeks|Intention to Treat (ITT)|||mm Hg||Standard Deviation|Mean
2749636|NCT00879398|Secondary|Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics|"Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as effective. Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) ."|At the end of study treatment|PP Population|||Percentage of Participants||95% Confidence Interval|Number
2749637|NCT00879398|Secondary|Participant Perception of Bladder Condition at the End of Study Treatment|Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.|Baseline and at the end of study treatment|PP Population|||Participants|||Number
2749638|NCT00879398|Secondary|Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment|The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.|||Number of Episodes per 24 Hours||Standard Deviation|Mean
2749639|NCT00879398|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment|The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.|||Number of Episodes per 24 Hours||Standard Deviation|Mean
2749640|NCT00879398|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment|The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.|||Number of Episodes per 24 Hours||Standard Deviation|Mean
2749641|NCT00879398|Primary|Investigator's Final Assessment of Effectiveness at the End of Study Treatment|The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).|At the end of study treatment|Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints.|||Percentage of Participants|||Number
2749642|NCT00879398|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.|Safety Analysis Set|||Percentage of Participants|||Number
2749643|NCT00879359|Secondary|Number of Participants With Adverse Events Grades 1-5|Toxicity and safety was monitored before every treatment cycle, during, and after treatment. Bevacizumab was discontinued if the following criteria was met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.|58 months||||participants|||Number
2749664|NCT00879229|Secondary|Long-term Survival|Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.|Week 48|Full Analysis Set|||percent probability (KM% estimate)||95% Confidence Interval|Number
2749644|NCT00879359|Secondary|Median Progression Free Survival of This Treatment Regimen in Patients With Advanced/Recurrent Endometrial Cancer.|Median progression free survival measured in months. Progression of disease is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of the target lesions, or a measurable increased in a non-target lesion, or the appearance of a new lesion.|58 months||||months||Full Range|Median
2749645|NCT00879359|Primary|Number of Participants With Progression Free Survival (PFS=Date of Progression of Disease or Death) at 6 Months Using Bevacizumab, Carboplatin, and Paclitaxel in Patients With Measurable Disease for Advanced/Recurrent Endometrial Cancer|Number of patients with progression free survival measured at 6 months. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of target lesions, or a measure increase in a non-target lesion, or the appearance of new lesions.|58 months||||Participants|||Count of Participants
2749646|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.|||ng/mL||Standard Deviation|Mean
2749647|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.|||ng/mL||Standard Deviation|Mean
2749648|NCT00879333|Secondary|Overall Response Rate (ORR)|ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Participants|||Number
2749649|NCT00879333|Secondary|Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2749650|NCT00879333|Secondary|Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores|The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2749665|NCT00879229|Primary|Change From Baseline in Six-minute Walk Distance (6MWD).|The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.|Baseline to Week 16|Participants in the Full Analysis Set (randomized and received at least one dose of study medication) with evaluable data were analyzed.|||meters||Standard Error|Mean
2749666|NCT00879190|Secondary|Neonatal Clinical Sepsis (Early Onset)||Up to 6 weeks after delivery||||affected neonates|||Number
2749667|NCT00879190|Secondary|Composite Maternal Morbidity|Composite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus.|Up to 6 weeks after delivery||||Participants|||Count of Participants
2749651|NCT00879333|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2749652|NCT00879333|Primary|Overall Survival (OS)|The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
2749653|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.|6 months post-treatment||||units on a scale||Standard Error|Mean
2749654|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|3-month Post-treatment||||units on a scale||Standard Error|Mean
2749655|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|Post-treatment (two-weeks following end of treatment)||||units on a scale||Standard Error|Mean
2749656|NCT00879229|Secondary|Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)|The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.|Baseline to Week 16|Insufficient data due to study termination||||||
2749657|NCT00879229|Secondary|Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)|Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.|Baseline to Week 16|Insufficient data due to study termination||||||
2749658|NCT00879229|Secondary|Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination||||||
2749659|NCT00879229|Secondary|Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 16|Insufficient data due to study termination||||||
2749660|NCT00879229|Secondary|Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.|Baseline to Week 16|Insufficient data due to study termination||||||
2749661|NCT00879229|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination||||||
2749662|NCT00879229|Secondary|Change From Baseline in WHO Functional Class|"WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase (+1: Improved), decrease (-1: Deteriorated), or no change (0: No change) on the scale."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.|||units on a scale|||Number
2749663|NCT00879229|Secondary|Transition Dyspnea Index (TDI)|"The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic Baseline Dyspnea Index. The TDI range is -9 to +9 (worst to best; 0 = no change)."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.|||units on a scale||Standard Deviation|Mean
2749669|NCT00879034|Secondary|To Obtain Baseline Clinical and Laboratory Data so That Longer-term Measures of Efficacy Will be Achievable if Treatment Continues Beyond the 4-week Feasibility Study Period.|The number of participants from whom baseline clinical and Laboratory data was obtained.|4 weeks||||Participants|||Count of Participants
2749670|NCT00879034|Secondary|To Assay for the Inhibition of HDJ-2 Farnesylation in Peripheral Blood Leukocytes (PBL)||4 weeks|This data was not collected for this feasibility study. HDJ-2 assessment in these 5 patients was analyzed at the end of a different protocol, NCT00916747.||||||
2749671|NCT00879034|Secondary|To Assess the Pharmacokinetics of Lonafarnib in Patients With Progeria.||4 weeks|This data was not collected for this feasibility study. Pharmacokinetics assessment of lonafarnib in these 5 patients was analyzed at the end of a different protocol, NCT00916747.||||||
2749672|NCT00879034|Secondary|To Investigate Which Clinical and Laboratory Studies Are Needed to Monitor or Alter Therapy to Prevent Unacceptable Toxicity|The number of participants with abnormal CBC w/diff panel, LFTs, renal functions and lipid panels.|4 weeks||||Participants|||Count of Participants
2749673|NCT00879034|Secondary|To Describe Any Acute and Chronic Toxicities Associated With Treating Progeria Patients With the Combination of Zoledronic Acid, Pravastatin and Lonafarnib|Number of participants with acute and chronic toxicities associated with treating progeria patients with the combination of zoledronic acid, pravastatin and lonafarnib|4 weeks||||Participants|||Count of Participants
2749674|NCT00879034|Primary|The Primary Objective of This Study is to Evaluate the Feasibility of Administering Intravenous Zoledronic Acid, Oral Pravastatin and Oral Lonafarnib, to Patients With Progeria for a Minimum of 4 Weeks|Feasibility was assessed by determining the number of participants with adverse events occurring over the course of the 4 week study.|4 weeks|Results are reported for the 5 patients who completed the 4 weeks of therapy.|||Participants|||Count of Participants
2749675|NCT00878995|Secondary|1-year Survival|Number of participants who survived one year post study.|1 year post study|12 subjects started each group. 2 subjects withdrew after baseline from the testosterone group.|||Participants|||Count of Participants
2749676|NCT00878995|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks|Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).|7 weeks|20 subjects completed this questionnaire at this time point.|||scores on a scale||Standard Deviation|Mean
2749677|NCT00878995|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline|Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).|Baseline|19 subjects completed this questionnaire at this time point.|||scores on a scale||Standard Deviation|Mean
2749678|NCT00878995|Secondary|Mood as Measured by Profile of Mood States at 7 Weeks|"Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being not at all' and 4 being extremely. There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best)."|7 weeks|20 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
2749679|NCT00878995|Secondary|Mood Measured by Profile of Mood States at Baseline|"Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being not at all' and 4 being extremely. There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best)."|baseline|22 subjects completed this questionnaire at this time point.|||units on a scale||Standard Deviation|Mean
2749680|NCT00878995|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|7 weeks|20 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
2749681|NCT00878995|Secondary|Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline|21 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
2749700|NCT00878995|Secondary|Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749682|NCT00878995|Secondary|Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks|The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99|7 weeks|21 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
2749683|NCT00878995|Secondary|Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline|The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.|baseline|20 subjects completed this questionnaire at this time point.|||units on a scale||Standard Deviation|Mean
2749684|NCT00878995|Secondary|Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks|Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.|7 weeks|24 subjects began the study, 2 were dis-enrolled, 22 subjects finished the study. All 22 subjects completed this outcome measure at 7 weeks.|||grams||Standard Deviation|Mean
2749685|NCT00878995|Secondary|Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline|Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit|baseline|24 subjects were able to complete this outcome measure at the baseline study visit.|||grams||Standard Deviation|Mean
2749686|NCT00878995|Secondary|Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749687|NCT00878995|Secondary|Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749688|NCT00878995|Secondary|Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749689|NCT00878995|Secondary|Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749690|NCT00878995|Secondary|Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749691|NCT00878995|Secondary|Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749692|NCT00878995|Secondary|Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749693|NCT00878995|Secondary|Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749694|NCT00878995|Secondary|Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749695|NCT00878995|Secondary|Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749696|NCT00878995|Secondary|Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749697|NCT00878995|Secondary|Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749698|NCT00878995|Secondary|Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749699|NCT00878995|Secondary|Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749870|NCT00877929|Secondary|SBP Control 140 at Four Weeks|Mean seated SBP < 140 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
2749701|NCT00878995|Secondary|Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749702|NCT00878995|Secondary|Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749703|NCT00878995|Secondary|Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749704|NCT00878995|Secondary|Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749705|NCT00878995|Secondary|Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749706|NCT00878995|Secondary|Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749707|NCT00878995|Secondary|Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749708|NCT00878995|Secondary|Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks|Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749709|NCT00878995|Secondary|Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749710|NCT00878995|Secondary|Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks|Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749711|NCT00878995|Secondary|Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline|Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
2749712|NCT00878995|Secondary|Physical Activity Levels as Measured by the ActiGraph Accelerometer|Physical activity is reported as % time sedentary for the entire 7 week study.|through study completion,up to 7 weeks|Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed.|||% time sedentary||Standard Deviation|Mean
2749713|NCT00878995|Secondary|Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks|Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.|7 weeks|Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.|||kilo-calories per day||Standard Deviation|Mean
2749714|NCT00878995|Secondary|Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline|Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.|Baseline|24 subjects completed this outcome measure at the baseline visit.|||kilo-calories per day||Standard Deviation|Mean
2749715|NCT00878995|Secondary|Body Weight as Measured by Scale at 7 Weeks.|Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.|7 weeks|22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit.|||Kilograms||Standard Deviation|Mean
2749716|NCT00878995|Secondary|Body Weight as Measured by Scale at Baseline|Body weight in kilograms as measured by a scale at the baseline visit.|Baseline|24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point.|||Kilograms||Standard Deviation|Mean
2749717|NCT00878995|Secondary|Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.|7 weeks|Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.|||Watts||Standard Deviation|Mean
2749718|NCT00878995|Secondary|Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.|Baseline|24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.|||Watts||Standard Deviation|Mean
2749719|NCT00878995|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.|7 weeks|Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.|||Newton-Meters||Standard Deviation|Mean
2749720|NCT00878995|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.|Baseline|24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.|||Newton-Meters||Standard Deviation|Mean
2749721|NCT00878995|Primary|Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.|Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.|7 weeks|Reporting data for the 22 completing subjects only, since this data is reported as change over time.|||Percent change||Standard Deviation|Mean
2749722|NCT00878969|Primary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|baseline and 18 months|Based on our power calculations, we needed 210 subjects to complete the study to be able to detect an effect. Given that only 37 subjects completed the study (18% of goal), no formal analyses were performed. Specifically, data were not collected for this assessment for any of the participants enrolled in the study.||||||
2749723|NCT00878878|Primary|Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.|||Wood Units||Standard Deviation|Mean
2749724|NCT00878878|Secondary|Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.|"Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.~The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.~This is per sequence and not a cross-over study."|During the injection and catheterization procedure, and for up to 24 hours post-injection|The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.|||Adverse Events|||Number
2749725|NCT00878878|Primary|Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.|||mm Hg||Standard Deviation|Mean
2749726|NCT00878826|Secondary|Side Effect - Bruising||Enrollment through 6 weeks postpartum||||participants|||Number
2749727|NCT00878826|Secondary|Bleeding Events||Enrollment through 6 weeks postpartum||||participants|||Number
2749728|NCT00878826|Secondary|Thromboembolic Events||Enrollment through 6 weeks postpartum||||participants|||Number
2749729|NCT00878826|Primary|Peak Anti-Xa Level|Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.|One measurement per trimester of pregnancy, up to 36 weeks||||u/ml||Standard Deviation|Mean
2749730|NCT00878800|Secondary|Belinostat t½|Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.|||hours||Geometric Coefficient of Variation|Geometric Mean
2749731|NCT00878800|Secondary|Belinostat Cmax|Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749732|NCT00878800|Secondary|Belinostat AUC (Time 0 to Last Measurement)|Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2749871|NCT00877929|Secondary|SBP Control 140 at Six Weeks|Mean seated SBP < 140 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
2749872|NCT00877929|Secondary|Systolic Blood Pressure (SBP) Control 140 at Eight Weeks|Mean seated SBP < 140 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
2749733|NCT00878800|Primary|Objective Response (CR and PR)|Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.|||percentage of participants|||Number
2749734|NCT00878800|Primary|Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment|Throughout study||||Dose limiting toxicity|||Number
2749735|NCT00878800|Secondary|Disease Control Rate (CR or PR or SD)|The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.|||percentage of participants|||Number
2749736|NCT00878800|Secondary|Time to Progression||Throughout study, after every 2 cycles|Includes only patients with disease progression.|||months||95% Confidence Interval|Median
2749737|NCT00878800|Secondary|Duration of Response||Throughout study, after every 2 cycles|Includes only patients with response|||Months||95% Confidence Interval|Median
2749738|NCT00878800|Secondary|Time to Response||Throughout study, after every 2 cycles|Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group.|||months||Full Range|Median
2749739|NCT00878800|Primary|Maximum Tolerated Dose (MTD) of Doxorubicin|Maximum Tolerated Dose (MTD) of doxorubicin|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks||||mg/m2|||Number
2749740|NCT00878800|Primary|Maximum Tolerated Dose (MTD) PXD101|Maximum Tolerated Dose (MTD) of PXD101treatment|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks||||mg/m²|||Number
2749741|NCT00878722|Secondary|Elimination t½||Cycle 1, Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d|||Hours||Standard Deviation|Mean
2749742|NCT00878722|Secondary|Belinostat AUC (Area Under Curve)||Cycle 1, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d|||ng*hrs/mL||Standard Deviation|Mean
2749743|NCT00878722|Secondary|Belinostat Cmax|Cmax: Arm A: at Cycle 1 Day 4, Cycle 1 Day 5 Arm B: Cycle 1 Day 1 and Cycle 1 Day 2|Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d|||ng/mL||Standard Deviation|Mean
2749744|NCT00878722|Secondary|Remission Duration|Remission duration: time (weeks) from date of remission status to disease relapse.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Remission duration was reported among participants who reported response|||Weeks||95% Confidence Interval|Mean
2749745|NCT00878722|Secondary|Event-Free Survival|Event-free survival: time (weeks) from entry into study until treatment failure, disease relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle||||Weeks||95% Confidence Interval|Median
2749746|NCT00878722|Secondary|Relapse-Free Survival|Relapse-free survival: time (weeks) from leukemia-free state to relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Relapse free survival was reported among participants who reported response|||Weeks|||Number
2749747|NCT00878722|Secondary|Overall Survival|Overall survival: time in weeks from entry into study until death from any cause. All patients without this endpoint at the time of discontinuation or the end of trial have been censored.|Throughout study, after each cycle for the first two cycles, then after every second cycle||||Weeks||95% Confidence Interval|Median
2749748|NCT00878722|Secondary|Duration of Response (CR and PR)|Duration of Response (CR and PR) in Weeks|Throughout study, after each cycle for the first two cycles, then after every second cycle|All patients who received at least one dose of belinostat and/or idarubicin were included in the full analysis set (FAS). Duration of response was reported among participants who reported response|||weeks||Full Range|Mean
2749749|NCT00878722|Secondary|Time to Response (CR and PR)|Time to response: time in weeks from first treatment to obtainment of the particular response status (CR and PR)|Throughout study, after each cycle for the first two cycles, then after every second cycle|Time to response was reported among participants who reported response|||Weeks||95% Confidence Interval|Median
2749750|NCT00878722|Primary|Overall Response|Efficacy measured as Response rate (complete response ([CR] and Complete remission with incomplete recovery of platelets [CRi]) and partial response ([PR])) using the response criteria of the International Working Group (Cheson et al 2003). CR includes CRi, CRc (Cytogenetic complete remission), and CRm (Molecular complete remission).|Throughout study, after each cycle for the first two cycles, then after every second cycle||||participants|||Number
2749751|NCT00878722|Primary|Maximum Tolerated Dose, Dose Limiting Toxicity|DLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle|First Cycle||||participants|||Number
2749752|NCT00878709|Secondary|Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2|Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
2749753|NCT00878709|Secondary|Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm|CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
2749754|NCT00878709|Secondary|Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
2749755|NCT00878709|Secondary|Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm|Time to distant recurrence is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
2749756|NCT00878709|Secondary|Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
2749757|NCT00878709|Secondary|Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm|Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
2749758|NCT00878709|Secondary|Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
2749759|NCT00878709|Secondary|Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm|Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
2749760|NCT00878709|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death from any cause|From time of randomization to death||2020-07-31|07/2020||||
2749761|NCT00878709|Primary|Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
2749762|NCT00878709|Primary|Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm|Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
2749763|NCT00878644|Secondary|Neuropsychological Scores (for Participants That Survive)|Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.|Measured at Month 12|Randomized children alive at one year with neuropsychological score available.|||Participants|||Count of Participants
2749764|NCT00878644|Secondary|Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest|Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)|||Participants|||Count of Participants
2749765|NCT00878644|Secondary|Survival|Survival at one year after cardiac arrest|Measured at one-year anniversary of cardiac arrest.|All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.|||Participants|||Count of Participants
2749766|NCT00878644|Primary|Survival With Good Neurobehavioral Outcome|Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|Subjects with baseline VABS-II >= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.|||Participants|||Count of Participants
2749767|NCT00878605|Primary|Hemoglobin A1C|% change HgbA1c from baseline to 12 weeks.|Baseline and Week 12|||||||
2749768|NCT00878553|Secondary|Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the plasma Half-Life (t1/2 in hours) of SKP-1041 zaleplon the each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA)for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||hour|Participants|Standard Error|Mean
2749769|NCT00878553|Secondary|AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC/Dose (ng*h/mL/mg) [Area under the concentration-time curve per Dose of SKP-1041 zaleplon] for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng*h/mL/mg|Participants|Standard Error|Mean
2749770|NCT00878553|Secondary|AUC Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC (area under the concentration-time curve of SKP-1041 zaleplon) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics were calculated for AUC. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng x h/mL|Participants|Standard Error|Mean
2749771|NCT00878553|Secondary|Tmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Tmax (hour) (timepoint post-dose of maximum plasma zaleplon concentration) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||Hours post-dose|Participants|Standard Error|Mean
2749772|NCT00878553|Secondary|Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Cmax/Dose (ng/mL/mg) (maximum plasma zaleplon concentration normalized per dose) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics, geometric means and 90% confidence intervals were calculated for dose-normalized values of Cmax. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng/mL/mg zaleplon|Participants|Standard Error|Mean
2749773|NCT00878553|Secondary|Cmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the Cmax (maximum plasma concentration of SKP-1041 zaleplon in ng/mL) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng/mL|Participants|Standard Error|Mean
2749774|NCT00878553|Secondary|Visual Analog Scale (Sedation)|"Self-assessment of next morning sedation. Patients answered the question How alert do you feel? via a 100mm scale on which 0mm indicated very sleepy and 100mm indicated wide awake and alert.The VAS measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (in this case, sleepiness and alertness). Patients were asked to mark the point on the line that they felt represented their current state. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked."|9 hours after tablet ingestion|Safety population (patients exposed to that given treatment)|||mm change from baseline||Standard Error|Mean
2749775|NCT00878553|Secondary|Digit Span Test|Assessment of next day residual cognitive effects via testing immediate recall of numbers. The patient was given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score was the number of correct responses, where the digits were repeated correctly. One point was given for each correctly repeated string of digits. The maximum subscore in the Digits Forward was 16, and the maximum subscore in the Digits Backward was 14, for a total score of 30.|9 hours post-dose|Intention to Treat population (all randomized patients)|||units on a scale change from baseline||Standard Error|Mean
2749776|NCT00878553|Secondary|Digit Symbol Substitution Test|Assessment of next-day residual cognitive effects. The Digit Symbol Substitution Test (DSST) explores attention and psychomotor speed. Given a code table displaying the correspondence between pairs of digits (from 1 to 9) and symbols, the patient filled in blank squares with the symbol that was paired with the digit displayed above the square. The patient was required to fill in as many squares as possible in 180 seconds.|9 hours after tablet ingestion|Intention to Treat population (all randomized patients)|||percentage change from mean baseline||Standard Error|Mean
2749777|NCT00878553|Secondary|Subjective Wake Time After Sleep Onset (sWASO)|Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment|9 hours after tablet ingestion|All Efficacy Analyses were performed on the Intention to Treat (ITT) population (all randomized patients).|||minutes||Standard Error|Mean
2749778|NCT00878553|Secondary|Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)|Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)|hours 3-7 (inclusive) post-dose|Intention to Treat dataset (all randomized patients)|||Number of awakenings||Standard Error|Mean
2749779|NCT00878553|Secondary|Total Sleep Time 3-7 Hours Post-dose|Total Sleep Time during hours 3-7 (inclusive) post-dose|hours 3-7 (inclusive) post-dose|Intention to Treat population (all randomized patients)|||Minutes||Standard Error|Mean
2749780|NCT00878553|Secondary|WASO 1-8|Wake Time After Sleep Onset, measured in minutes over the full 8 hour polysomnographic recording period, is summarized by treatment group for each night during the Screening and Treatment Periods.|Constantly throughout the 8 hour sleep period|Intention to Treat population|||Minutes||Standard Error|Mean
2749781|NCT00878553|Primary|Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)|Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.|Hours 3-7 (inclusive) after tablet ingestion|Efficacy analyses were performed on the Intention to Treat Population(all randomized patients).|||minutes||Standard Error|Mean
2749782|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
2749783|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
2749784|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.|The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
2749785|NCT00878501|Primary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.|The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.|Baseline, week 2, week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
2749786|NCT00878436|Secondary|Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy|Unable to locate PI for secondary outcome measure results. Data is not available.|9 months|Unable to locate PI for secondary outcome measure results. Data is not available.||||||
2749787|NCT00878436|Secondary|Time to PSA Progression|PSA progression is defined as a 25% or greater increase in PSA and an absolute increase value of 2 ng/ml or more over a nadir or baseline documented and confirmed by a second value three weeks later|up to 2 years|Unable to locate PI for secondary outcome measure results. Data is not available.||||||
2749873|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
2749874|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
2749788|NCT00878436|Primary|Percentage of Patients Free of Progression and Without Symptomatic Deterioration|"measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression.~Only participants who completed two or more treatment cycles were assessed for this outcome measure."|6 months||||percentage of participants|||Number
2749789|NCT00878436|Primary|Percentage of Patients Free of Progression and Without Symptomatic Deterioration|"measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression.~Only participants who completed two or more treatment cycles were assessed for this outcome measure."|9 months||||percentage of Participants|||Number
2749790|NCT00878228|Secondary|Impact of Nausea and Vomiting on Quality of Life|Percentage of participants whose quality of life was impacted by nausea and vomiting|Postdischarge Day 1||||percentage of participants|||Number
2749791|NCT00878228|Secondary|Severity of Nausea|Percentage of participants reporting moderate or severe nausea in the first 24 hours|Postdischarge Day 1||||percentage of participants|||Number
2749792|NCT00878228|Primary|Incidence of Nausea|Percentage of participants with nausea|Postdischarge Day 1||||percentage of participants|||Number
2749793|NCT00878215|Primary|The Number of Participants Who Have Complete Ablation According to Early Post-ablative Imaging Studies as Well as no Recurrence of the Tumor Within 6 Months (Phase 4 Portion of the Study)|-A successful endpoint will be a 90% success rate of complete ablation according to early post-ablative imaging studies as well as no recurrence of the tumor within 6 months.|6 months post-ablation|The study closed early as the imaging-guidance system became commercially available as the Explorer Liver Image Guided System and the Explorer Liver Passive Tracking device.||||||
2749794|NCT00878215|Primary|Target Accuracy of an Ablation Probe Using Image-guided Surgery Technology as Measured by the Number of Participants Who Had Ablation Burns Within a 5mm Radius of the Tumor Centroid (Phase 3 Portion of Study)|-A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.|Completion of surgery|The study closed early as the imaging-guidance system became commercially available as the Explorer Liver Image Guided System and the Explorer Liver Passive Tracking device.||||||
2749795|NCT00878215|Primary|Accuracy With Which Image-guided Surgery (IGS) Can be Used to Implant a Ceramic Bead Inside a Tumor as Measured by Successful Deliveries of the Bead to Within 8mm of the Pre-operatively Planned Target Point (Phase 2 Portion of Study)|"Calculation of bead delivery accuracy using the IGS system involves the acquisition of images of the resected specimen and then the co-registration of the post-resection images to the pre-operative image set. Given that the target location is marked in the pre-operative image set and the registration calculation allows an overlay of the two image sets a Euclidean distance error can be calculated between the true bead location and the pre-operatively determined target. Given that the error involved in computing the registration between the two image sets is included within the bead delivery target error calculation it is imperative that the impact of registration error is minimized.~Numbers represented are the distance between the planned target site and the true bead location"|Completion of surgery|10 patients were excluded as they were determined to be ineligible after enrollment but prior to surgery.|||mm|||Number
2749796|NCT00878215|Primary|Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)|"10 successful intraoperative registrations with no more than 30% failure rate over all the cases will be considered a successful endpoint~A successful registration is defined as one which yields an RMS surface residual of ≤ 10 mm and is determined to be success after qualitative evaluation."|Completion of surgery|2 patients were excluded due to the fact that liver surface data was not acquired for these cases due to equipment malfunctions and not due to a failure in the guidance method in general.|||participants|||Number
2749797|NCT00878189|Post-Hoc|Time to Response (TTR) for Solid Tumor Participants|Time to response (TTR) was only defined for participants with an objective response (OR). TTR (months) was calculated as (date of first documentation of PR or CR minus date of first dose of study medication plus 1) divided by 30.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or -5 days) of every odd cycle or as clinically indicated, up to Cycle 9. Afterwards, assessed on Day 1 (+ or -5 days) every 4 cycles.|Only solid tumor participants with an OR were analyzed.|||months||95% Confidence Interval|Median
2749798|NCT00878189|Secondary|Changes From Baseline in Notch Intracellular Domain (NICD) Levels in Bone Marrow for T-ALL/LBL Participants|Notch intracellular domain (NICD) was to be measured in bone marrow monoculear cell (BMMC) cell pellets using a validated ELISA.|Baseline, Cycle 1 Day 1 and Cycle 2 Day 1|NICD analyses in bone marrow samples were not done because the number of bone marrow samples received was insufficient and because the analyses were not mandatory per protocol.||||||
2749799|NCT00878189|Secondary|Changes From Baseline in Notch Intracellular Domain (NICD) Levels in Peripheral Blood for T-ALL/LBL Participants|Notch intracellular domain (NICD) levels was measured in peripheral blood mononuclear cell (PBMC) pellets using a validated enzyme-linked immunosorbent assay (ELISA).|Baseline, Cycle 1 Days 8 and 15 (pre-dose AM), Cycle 1 Day 21 (pre-dose AM and 24, 48 and 120 hr post-dose) and end of treatment (EOT).|No data were reported for the results of NICD measurement in T-ALL/LBL participants because NICD levels fell below the limit of quantitation of the assay in most cases.||||||
2749800|NCT00878189|Secondary|Changes in Expression Levels of Notch 1 Target Genes in Peripheral Blood for Solid Tumor Participants: Hes4 Gene Expression Level on Cycle 1 Day 8 and Cycle 1 Day 21 Relative to That at Baseline|Ribonucleic acid (RNA) was extracted from peripheral blood and used as a template to synthesize complementary deoxyribonucleic acid (cDNA). Gene expression in cDNA was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Results were reported Only for Hes4 as this was the only gene to show consistent down modulation across dosing cohorts (150 mg and 220 mg).|Baseline (morning), Cycle 1 Days 8 and 21 (pre-dose)|"Pharmacodynamic Biomarker analysis set was defined separately for T-ALL and advanced solid tumor malignancy participants. In both cases it will comprise all participants enrolled in study having at least one biomarker assessment at baseline and at least one assessment after being treated. Here, N signifies participants evaluable for this OM."|||ratio||Standard Deviation|Mean
2749801|NCT00878189|Secondary|Changes From Baseline in Expression Levels of Notch 1 Target Genes in Peripheral Blood for T-ALL/LBL Participants: Hes4 Gene Expression Levels on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 21 Relative to That at Baseline|Ribonucleic acid (RNA) was extracted from peripheral blood and used as a template to synthesize complementary deoxyribonucleic acid (cDNA). Gene expression in cDNA was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Results were reported Only for Hes4 as this was the only gene to show consistent down modulation across dosing cohorts (150 mg and 220 mg).|Baseline (morning), Cycle 1 Days 8, 15 and 21 (morning, matched with the first PK sample of the particular day), Cycle 1 Day 21 (24, 48, and 120 hr post-dose) and at end of treatment (EOT)|"Pharmacodynamic biomarker analysis set. In both cases, it will comprise all participants enrolled in study having at least 1 biomarker assessment at baseline and at least 1 assessment after being treated. Here, N=participants evaluable for this OM. This OM was planned to be analyze for T-ALL/LBL arm only."|||ratio||Standard Deviation|Mean
2749802|NCT00878189|Secondary|Changes in Expression Levels of Notch 1 Target Genes in Tumor Biopsies for Solid Tumor Participants: Hairy and Enhancer of Split-4 (Hes4) Gene Expression Levels on Cycle 1 Day 21 Relative to That at Baseline|Gene expression analysis in tumor biopsies was done using cDNA prepared from RNA extracted from tumor biopsies. Gene expression was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Only Hes4 gene showed consistent down modulation across dosing cohorts (150 mg and 220 mg BID) and therefore results were reported for Hes4 only. Data for this outcome measure was planned to be analyzed for two arms only.|Baseline, Cycle 1 Day 21 (-5 days)|"Pharmacodynamic Biomarker analysis set was defined separately for T-ALL and advanced solid tumor malignancy participants. In both cases it will comprise all participants enrolled in study having at least one biomarker assessment at baseline and at least one assessment after being treated. Here, N signifies participants evaluable for this OM."|||ratio||Standard Deviation|Mean
2749803|NCT00878189|Secondary|Peripheral Blast Count Reduction (PBR) for T-ALL/LBL Participants|PBR was the maximum percentage of peripheral blast count reduction for each participant who received at least one dose of study medication. PBR was derived by the Sponsor from percentage of peripheral blood Blast Count reported by sites.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)|Due to halting of T-AA/LBL participants enrollment and limited number of evaluable participants, data for PBR was not collected.||||||
2749804|NCT00878189|Secondary|Relapse Free Survival (RFS) for T-ALL/LBL Participants|The RFS of CR was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first. Similarly, the RFS of CR + CRi (or RFS of CR + CRi + PR) was defined as the time from the date of first attaining CR + CRi (or CR + CRi + PR) to the date of relapse or death from any cause, whichever occurred first.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)|Due to halting of T-AA/LBL participants enrollment and limited number of evaluable participants, data for RFS was not collected.||||||
2749805|NCT00878189|Secondary|Percentage of T-ALL/LBL Participants With OR|OR was adapted from International Working Group Response Criteria for Acute Myeloid Leukemia (AML). The response categories of interest were CR, complete response with incomplete hematopoietic recovery (CRi), and PR. CR: ANC >1500/microliter (uL), no circulating blasts. Platelets >100,000/uL, <5% marrow blast cells, no extramedullary disease, bone marrow cellularity >20% with tri-lineage hematopoiesis and <5% marrow blast cells, none of which were neoplastic; CRi: same as CR but ANC may be >1500/uL or platelet count >100,000/uL, no requirement on bone marrow cellularity; PR: same as CR but bone marrow with >= 50% reduction of leukemia blast cells and an absolute blast count between 5% and 25%.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)|All T-ALL/LBL participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2749806|NCT00878189|Secondary|Progression-Free Survival (PFS) for Solid Tumor Participants|PFS was defined as the time from Cycle 1 Day 1 to date of first documentation of progression or death due to any cause. Progression was defined as per RECIST version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions. PFS (months) was calculated as (the first event date minus the date of first dose of study medication plus 1) divided by 30.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9; afterwards assessed on Day 1 (+ or -5 days) every 4 cycles (up to maximum of 84 months)|All solid tumor participants who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2749807|NCT00878189|Secondary|Duration of Response (DR) for Solid Tumor Participants|Time from the first documentation of OR to objective disease progression or death due to any cause. DR was only calculated for participants with an OR. DR (months) was calculated as (date of first documentation of objective progression or death minus date of first documentation of PR or CR plus 1) divided by 30.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or -5 days) of every odd cycle or as clinically indicated, up to Cycle 9. Afterwards, assessed on Day 1 (+ or -5 days) every 4 cycles (up to maximum of 84 months)|Only solid tumor participants with an OR were analyzed; however, all these participants were censored as of the time of data cut-off on 09 January 2013. Of these 6 participants, 4 participants were still on study with 1 participant discontinued for non-compliance and the other 1 participant missing tumor assessment.|||months||95% Confidence Interval|Median
2749808|NCT00878189|Secondary|Time to Tumor Progression (TTP) for Solid Tumor Participants|Time from Cycle 1 Day 1 to first documentation of disease progression. Progression was defined as per RECIST version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, uneuivocal progression of non-target disease, or the appearance of new lesions. TTP (months) was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.|Baseline until first documented objective progression (up to maximum of 84 months)|All solid tumor participants who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2749809|NCT00878189|Secondary|Percentage of Solid Tumor Participants With Objective Response (OR)|Objective response (OR) was defined as confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as >=30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (plus [+] or minus [-] 5 days) of every odd cycle or as clinically indicated, up to Cycle 9; afterwards assessed on Day 1 (+ or -5 days) every 4 cycles|All solid tumor participants who received study treatment, had baseline assessments and at least 1 on study tumor assessment prior to any new anti-cancer therapies were considered evaluable for response.|||percentage of participants||95% Confidence Interval|Number
2749810|NCT00878189|Secondary|Tmax on Cycle 2 Day 1|Tmax was the time to reach maximum serum concentration (Cmax). Data for this outcome measure was planned to be analyzed for two arms only.|Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||hr||Full Range|Median
2749811|NCT00878189|Secondary|Dose-normalized Cmax [Cmax (dn)] on Cycle 2 Day 1|Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. Data for this outcome measure was planned to be analyzed for two arms only.|Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749812|NCT00878189|Secondary|Cmax on Cycle 2 Day 1|Cmax was the maximum observed serum concentration. Data for this outcome measure was planned to be analyzed for two arms only.|Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749813|NCT00878189|Secondary|Dose-normalized AUCtau [AUCtau (dn)] on Cycle 2 Day 1|AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. Data for this outcome measure was planned to be analyzed for two arms only.|Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749814|NCT00878189|Secondary|AUCtau on Cycle 2 Day 1|AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Data for this outcome measure was planned to be analyzed for two arms only.|Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2749815|NCT00878189|Secondary|Dose-Normalized Cmax [Cmax(dn)] in the Fed State for Solid Tumor Participants|Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose).|Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (9 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749816|NCT00878189|Secondary|Dose-normalized Cmax [Cmax(dn)] in the Fasted State for Solid Tumor Participants|Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Participants who were enrolled in the food-effect sub-study, started treatment and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (9 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749817|NCT00878189|Secondary|Dose-normalized AUCtau [AUCtau(dn)] in the Fed State for Solid Tumor Participants|AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Solid tumor participants who were enrolled in the food-effect sub-study, started treatment and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (7 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for 2 dose levels.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749818|NCT00878189|Secondary|Dose-normalized AUCtau [AUCtau(dn)] in the Fasted State for Solid Tumor Participants|AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (7 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749819|NCT00878189|Secondary|Cmax in the Fed State for Solid Tumor Participants|Cmax was the maximum observed serum concentration.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749820|NCT00878189|Secondary|Cmax in the Fasted State for Solid Tumor Participants|Cmax was the maximum observed serum concentration.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749821|NCT00878189|Secondary|AUCtau in the Fed State for Solid Tumor Participants|AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval).|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2749822|NCT00878189|Secondary|AUCtau in the Fasted State for Solid Tumor Participants|AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval).|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)|Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2749823|NCT00878189|Secondary|Dose-normalized Cmax [Cmax (dn)] After Multiple Dose on Cycle 1 Day 21|Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749824|NCT00878189|Secondary|Dose-normalized AUCtau [AUCtau (dn)] After Multiple Dose on Cycle 1 Day 21|AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749825|NCT00878189|Secondary|Accumulation Ratio (Rac) on Cycle 1 Day 21|Accumulation was calculated as AUCtau at steady state (Cycle 1 Day 21) divided by AUCtau after a single dose on Cycle 1 Day 1. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose), Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM.|||ratio||Full Range|Median
2749826|NCT00878189|Secondary|Average Serum Concentration (Cavg) at Steady State on Cycle 1 Day 21|Cavg was the average serum concentration at steady state. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749827|NCT00878189|Secondary|Minimum Observed Serum Concentration (Cmin) After Multiple Dose on Cycle 1 Day 21|Cmin was the minimum serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749828|NCT00878189|Secondary|Apparent Oral Clearance (CL/F) on Cycle 1 Day 21|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2749829|NCT00878189|Secondary|Serum Decay Half-Life (t1/2) After Multiple Dose on Cycle 1 Day 21|Serum decay half-life (t1/2) is the time measured for the serum concentration to decrease by one half. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||hours||Standard Deviation|Mean
2749830|NCT00878189|Secondary|Apparent Volume of Distribution (Vz/F) on Cycle 1 Day 21|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2749831|NCT00878189|Secondary|AUCtau After Multiple Dose on Cycle 1 Day 21|AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2749875|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
2749832|NCT00878189|Secondary|Time to Reach Cmax (Tmax) After Multiple Dose on Cycle 1 Day 21|Tmax was the time to reach maximum serum concentration (Cmax). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM|||hour||Full Range|Median
2749833|NCT00878189|Secondary|Cmax After Multiple Dose on Cycle 1 Day 21|Cmax was the maximum observed serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. CV is the coefficient of variation.|Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)|All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749834|NCT00878189|Secondary|Time to Reach Cmax (Tmax) After a Single Dose on Cycle 1 Day 1|Tmax was the time to reach maximum serum concentration (Cmax).|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||hours||Full Range|Median
2749835|NCT00878189|Secondary|Dose-normalized AUCtau [AUCtau (dn) ] After a Single Dose on Cycle 1 Day 1|AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. NE is not estimable.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749836|NCT00878189|Secondary|Area Under the Time-Concentration Curve From Time 0 to the Dosing Interval (AUCtau) After a Single Dose on Cycle 1 Day 1|AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). CV is the coefficient of variation.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. Overall Number of Participants Analyzed (N) =number of participants evaluable for this outcome measure (OM).|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2749837|NCT00878189|Secondary|Dose-normalized Cmax [Cmax (dn)] After a Single Dose on Cycle 1 Day 1|Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2749838|NCT00878189|Secondary|Maximum Observed Serum Concentration (Cmax) After a Single Dose on Cycle 1 Day 1|Cmax was the maximum observed serum concentration.|Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)|All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this outcome measure (OM).|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2749839|NCT00878189|Secondary|Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles)|Parameters analyzed included: white blood cell (WBC) count plus differential, absolute (abs) neutrophil count, platelets, hemoglobin, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, creatinine, glucose, uric acid, calcium, phosphate, magnesium, total protein, albumin, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), partial prothrombin time/international normalized ratio (PTT/INR). Urinalysis: pH, specific gravity, protein, glucose, ketones, blood, leukocyte esterase, and nitrites. Pregnancy test: Serum or urine pregnancy test for women of childbearing potential. There were no changes in urine protein among the solid tumor and T-ALL/LBL participants that were clinically significant. Clinical significance was judged by the investigator.|Baseline up to end of study (maximum of 84 months)|All participants who received at least 1 dose of study medication.|||participants|||Number
2749840|NCT00878189|Secondary|Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval|Criteria for potentially important changes in ECG were defined as: maximum (max.) post-dose (post-baseline) time from electrocardiogram Q wave to the corresponding to electrical systole (QT interval) corrected for Fridericia's factor (QTcF), or QT interval corrected for Bazett's factor (QTcB): <450, 450 -<480, 480-<500, and >=500 msec. Maximum increase (inc.) from baseline in QTcF or QTcB: change (chg) <30, 30>=chg<60, and chg >=60 msec.|Baseline up to end of study (maximum of 84 months)|All participants who received at least 1 dose of study medication.|||participants|||Number
2749841|NCT00878189|Secondary|Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE.|Baseline up to end of study (maximum of 84 months)|All participants who received at least 1 dose of study medication.|||participants|||Number
2749842|NCT00878189|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE.|Baseline up to end of study (maximum of 84 months)|All participants who received at least 1 dose of study medication.|||participants|||Number
2749876|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
2749877|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
2749843|NCT00878189|Secondary|Number of Participants With TEAEs (Treatment-Related)|An AE was any untoward medical occurrence in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.|Baseline up to end of study (maximum of 84 months)|All participants who received at least 1 dose of study medication.|||participants|||Number
2749844|NCT00878189|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of casual relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.|Baseline up to end of study (maximum of 84 months)|All participants who received at least 1 dose of study medication.|||participants|||Number
2749845|NCT00878189|Primary|Number of T-ALL/LBL Participants With First-Cycle DLT|Any DLT attributable to PF-03084014 at 1st Cycle: non-hematologic toxicities >= Grade 3 despite optimal care; treatment delay >=7 days; unable to deliver at least 80% of planned dose; absolute neutrophil count (ANC) <1000/microliter (uL), or platelet count <30,000/uL, or hemoglobin <8 gram/deciliter (g/dL) in a bone marrow with <5% blasts and no evidence of leukemia or abnormal dysplasia for >42 days|Baseline to the end of Cycle 1 (Week 4)|T-ALL/LBL participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs.|||participants|||Number
2749846|NCT00878189|Primary|Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT)|Any DLT event attributable to PF-03084014 during Cycle 1: non-hematologic toxicities >= Grade 3 despite optimal care; treatment delay >=7 days or unable to deliver at least 80% of planned dose due to treatment-related toxicities; Grade 4 neutropenia >7 days; febrile neutropenia; neutropenic infection; Grade >=3 thrombocytopenia with bleeding|Baseline to the end of Cycle 1 (Week 4)|Solid tumor participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs.|||participants|||Number
2749847|NCT00877929|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)|Change from baseline in UACR (measured in spot urine) after eight weeks of treatment|8 weeks|Treated set|||ratio||Standard Deviation|Mean
2749848|NCT00877929|Secondary|DBP Response at Week One|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 1|Treated set|||participants|||Number
2749849|NCT00877929|Secondary|DBP Response at Week Two|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 2|Treated set|||participants|||Number
2749850|NCT00877929|Secondary|DBP Response at Week Four|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 4|Treated set|||participants|||Number
2749851|NCT00877929|Secondary|DBP Response at Six Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|week 6|Treated set|||participants|||Number
2749852|NCT00877929|Secondary|DBP Response at Eight Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|Week 8|Treated set|||participants|||Number
2749853|NCT00877929|Secondary|SBP Response 130 at One Week|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
2749854|NCT00877929|Secondary|SBP Response 130 at Two Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
2749855|NCT00877929|Secondary|SBP Response 130 at Four Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
2749856|NCT00877929|Secondary|SBP Response 130 at Six Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
2749857|NCT00877929|Secondary|SBP Response 130 at Eight Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
2749858|NCT00877929|Secondary|SBP Response 140 at One Week|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
2749859|NCT00877929|Secondary|SBP Response 140 at Two Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
2749860|NCT00877929|Secondary|SBP Response 140 at Four Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
2749861|NCT00877929|Secondary|SBP Response 140 at Six Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
2749862|NCT00877929|Secondary|SBP Response 140 at Eight Weeks|SBP < 140 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
2749863|NCT00877929|Secondary|SBP Control 130 at One Week|Mean seated SBP < 130 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
2749864|NCT00877929|Secondary|SBP Control 130 at Two Weeks|Mean seated SBP < 130 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
2749865|NCT00877929|Secondary|SBP Control 130 at Four Weeks|Mean seated SBP < 130 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
2749866|NCT00877929|Secondary|SBP Control 130 at Six Weeks|Mean seated SBP < 130 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
2749867|NCT00877929|Secondary|SBP Control 130 at Eight Weeks|Mean seated SBP < 130 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
2749868|NCT00877929|Secondary|SBP Control 140 at One Week|Mean seated SBP < 140 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
2749869|NCT00877929|Secondary|SBP Control 140 at Two Weeks|Mean seated SBP < 140 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
2749883|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 1||||mmHg||Standard Error|Least Squares Mean
2749884|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 2||||mmHg||Standard Error|Least Squares Mean
2749885|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 4||||mmHg||Standard Error|Least Squares Mean
2749886|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 6||||mmHg||Standard Error|Least Squares Mean
2749887|NCT00877929|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 8|Treated Set includes all randomized participants who took at least one dose of treatment|||mmHg||Standard Error|Least Squares Mean
2749888|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.|||rate per subject-year||Standard Error|Mean
2749889|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.|||rate per subject-year||Standard Error|Mean
2749890|NCT00877890|Secondary|Ratio of Triglycerides at Week 24 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||Standard Error|Least Squares Mean
2749891|NCT00877890|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 24|Change in HDL from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2749892|NCT00877890|Secondary|Change in Total Cholesterol From Baseline to Week 24|Change in total cholesterol from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2749893|NCT00877890|Secondary|Change in Sitting Diastolic Blood Pressure From Baseline to Week 24|Change in diastolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
2749894|NCT00877890|Secondary|Change in Sitting Systolic Blood Pressure From Baseline to Week 24|Change in systolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
2749895|NCT00877890|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||Standard Error|Least Squares Mean
2749896|NCT00877890|Secondary|Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL|Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2749897|NCT00877890|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|Change in fasting plasma glucose from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2749898|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2749899|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2749900|NCT00877890|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].|Day 1, Week 24|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2749901|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 to Month 120||||Subjects|||Number
2749902|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 to Month 108||||Subjects|||Number
2749903|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 to Month 96||||Subjects|||Number
2749904|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 to Month 84|Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.|||Subjects|||Number
2749905|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 60 to Month 72|Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.|||Subjects|||Number
2749906|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 to Month 60|The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.|||Subjects|||Number
2749907|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.|||Subjects|||Number
2749908|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2749909|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 108|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.|||EL.U/ML||95% Confidence Interval|Geometric Mean
2749910|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 108|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.|||Subjects|||Number
2749911|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2749912|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2749913|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2749914|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2749915|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.|||Subjects|||Number
2749916|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.|||Subjects|||Number
2749917|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.|||Subjects|||Number
2749918|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.|||Subjects|||Number
2749919|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment||8 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 8-16 hour time interval.|||mg||Standard Deviation|Mean
2749920|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment||4 to 8 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 4-8 hour time interval.|||mg||Standard Deviation|Mean
2749921|NCT00877799|Secondary|Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment||0 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.|||mg||Standard Deviation|Mean
2749922|NCT00877799|Primary|Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint|"The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of some, a lot, or complete at 15 and 30 min following the start of the study drug infusion."|15 and 30 minutes after study drug administration|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.|||responders|||Number
2749923|NCT00877773|Primary|Tumor Response|For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).|Baseline to Disease Progression (restaged at 8 weeks and at 4 months)|Of the 44 participants enrolled, only 30 were evaluable for response.|||participants|||Number
2749931|NCT00877604|Primary|The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope.|Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R slope during the treatment period as compared to the lead-in period.|1 year||||participants|||Number
2749932|NCT00877487|Primary|Percent of Treatment Failures at up to 6 Weeks|Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.|Up to 6 weeks|Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.|||Percent of participants|||Number
2749933|NCT00877487|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 6 weeks|FAS|||Percent of Participants|||Number
2749934|NCT00877487|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Up to 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
2749935|NCT00877448|Primary|Treatment-related Adverse Events|Number of treatment-related adverse events per cohort|Day 0 until day 42 (termination visit)||||number of reported events|||Number
2749936|NCT00877448|Primary|Adverse Events|Number of adverse events per cohort|day 0 until day 42 (termination visit)||||number of reported events|||Number
2749937|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2749938|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2749939|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2749940|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2749941|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|End of the study (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2749942|NCT00877383|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2749943|NCT00877370|Primary|Ertapenem Transmembrane Clearance by Continuous Hemodialysis.||24 hours after receiving first 1 gram dose|All participants were included in the analysis.|||mL/min||Standard Deviation|Mean
2749944|NCT00877071|Secondary|The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
2749945|NCT00877071|Secondary|Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
2749946|NCT00877071|Secondary|The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
2749947|NCT00877071|Primary|The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM|Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.|36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
2749948|NCT00877058|Primary|Self Rated Health|"Self rated health was measured by the question In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed"|1 year|ITT|||participants|||Number
2749949|NCT00877058|Primary|Number of Partipants Measured Frail at 1-year Follow up|Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition|1 year|ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.|||participants|||Number
2749950|NCT00877058|Primary|Dependence in Two or More Activities of Daily Living (ADL)|"ADL stair case:~Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed"|1 year||||participants|||Number
2749951|NCT00877032|Secondary|Number of Participants With Anti-Drug Anti-body|Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||participants|||Number
2749952|NCT00877032|Secondary|Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)|AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||nanogram*hr/mL (ng*hr/mL)||Standard Deviation|Mean
2749953|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||hours||Full Range|Median
2749954|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacodynamic (PD) analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2749955|NCT00877032|Secondary|Plasma Terminal Half-life (t1/2) of RN6G|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||days||Standard Deviation|Mean
2749956|NCT00877032|Secondary|Mean Residence Time (MRT) of RN6G|MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||days||Standard Deviation|Mean
2749957|NCT00877032|Secondary|Clearance (CL) of RN6G|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||mL/hr/kg||Standard Deviation|Mean
2749958|NCT00877032|Secondary|Volume of Distribution (Vd) of RN6G|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||mL/kilogram (mL/kg)||Standard Deviation|Mean
2749959|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.|||hours||Full Range|Median
2749960|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.|||mcg/mL||Standard Deviation|Mean
2749961|NCT00877032|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.|||mcg*hr/mL||Standard Deviation|Mean
2749962|NCT00877032|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacokinetic (PK) analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
2749963|NCT00877032|Primary|Incidence and Severity of Systemic Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||participants|||Number
2749964|NCT00877032|Primary|Incidence and Severity of Ocular Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||participants|||Number
2749965|NCT00877006|Secondary|Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period|Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications.|Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period|Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.|||Participants|||Count of Participants
2749966|NCT00877006|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients|||months||95% Confidence Interval|Median
2749967|NCT00877006|Secondary|Kaplan-Meier Estimate for Duration of Response (DOR)|DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients with complete response (CR) or partial response (PR)|||months||95% Confidence Interval|Median
2749968|NCT00877006|Secondary|Kaplan-Meier Estimate for Event-free Survival (EFS)|"EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.~Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier."|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients|||months||95% Confidence Interval|Median
2749969|NCT00877006|Secondary|Kaplan-Meier Estimate for Progression-free Survival (PFS)|PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients|||months||95% Confidence Interval|Median
2750214|NCT00875433|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2749970|NCT00877006|Secondary|Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period|"Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):~Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.~In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.~>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis~other conditions as specified in the protocol"|Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period|Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.|||Participants|||Count of Participants
2749971|NCT00877006|Secondary|Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.|Day 1 (prior to treatment), 32 weeks|The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints.|||units on a scale||Standard Deviation|Mean
2749972|NCT00877006|Secondary|Therapeutic Classification of Concomitant Medications||32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.|||participants|||Number
2749973|NCT00877006|Secondary|Therapeutic Classification of Prior Medications||prior to start of treatment|Safety Analysis Set: all participants randomly assigned to a treatment group|||participants|||Number
2749974|NCT00877006|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period|Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status).|Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values.|||participants|||Number
2749975|NCT00877006|Secondary|Potentially Clinically Significant Abnormal Weight|Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant.|Baseline, Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight.|||participants|||Number
2749976|NCT00877006|Secondary|Clinically Significant Abnormal Vital Signs||32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values.|||participants|||Number
2749977|NCT00877006|Secondary|Worst Overall CTCAE Grade for Hematology Laboratory Test Results|Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment.|||participants|||Number
2749978|NCT00877006|Secondary|Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results|Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment.|||participants|||Number
2749979|NCT00877006|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period|AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event.|32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.|||participants|||Number
2750007|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2749980|NCT00877006|Secondary|Percentage of Participants With Overall Response at End of Treatment Period|Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2749981|NCT00877006|Primary|Percentage of Participants With Complete Response (CR) at End of Treatment Period|CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2749982|NCT00876993|Secondary|To Provide Safety and Efficacy Data for to Recommend Further Larger Studies.|Number participants with grade 3 and 4 hematologic and non-hematologic toxicities. All toxicities are for end of cycle 2.|Two 28 day cycles||||Participants|||Count of Participants
2749983|NCT00876993|Secondary|2 Year Event Free Survival With Children Treated With This Regimen.|2 year actual event free survival.with children treated with this protocol|2 year||||Count of participants|||Number
2749984|NCT00876993|Secondary|Best Response of Children With Recurrent or Refractory Central Nervous System Tumors With This Combination of Chemotherapy Agents.|Best response by MRIs per definitions in the protocol (complete response, partial response, stable disease, progressive disease). MRI's were obtained every 2 cycles and the best response was reported.|Every 2 cycles up to 24 cycles||||Participants|||Count of Participants
2749985|NCT00876993|Primary|Measurement of Number of Adverse Events|Collect and grade the all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.|Two 28-day cycles||||Adverse events|||Number
2749986|NCT00876928|Secondary|Disposition Index|Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better|Baseline, 3, 6, 9, 12 months|modified intent to treat|||Unitless||Standard Deviation|Mean
2749987|NCT00876928|Primary|Percent of Subjects Who Develop Diabetes|Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl|one year|Minorities with pre-diabetes and hypovitaminosis D|||percentage of participants|||Number
2749988|NCT00876915|Secondary|The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TAT|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||ug/L||Standard Deviation|Mean
2749989|NCT00876915|Secondary|The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of FVIIa|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||pM||Standard Deviation|Mean
2749990|NCT00876915|Secondary|The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TFPI|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||pg/mL||Standard Deviation|Mean
2749991|NCT00876915|Secondary|The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of Human F12|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||ng/mL||Standard Deviation|Mean
2749992|NCT00876915|Secondary|The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of D-Dimer|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||ug/mL||Standard Deviation|Mean
2749993|NCT00876915|Secondary|The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients.|baseline value of tissue factor|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||pg/mL||Standard Deviation|Mean
2750008|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 12.|||U/L||Standard Deviation|Mean
2749994|NCT00876915|Primary|Percentage of Patients Who Experienced Clinically Significant Bleeding Events.|The percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma > 25 cm², epistaxis > 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding > 5 mins, hemoptysis, hematemesis or prolonged bleeding (> 5 minutes) after venipuncture.|13 weeks||||percentage of participants|||Number
2749995|NCT00876915|Primary|Percentage of Patients With Venous Thromboembolisms|The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.|12 weeks||||percentage of participants|||Number
2749996|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.|||g/dL||Standard Deviation|Mean
2749997|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2749998|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.|||U/L||Standard Deviation|Mean
2749999|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for AST at baseline and at month 36.|||U/L||Standard Deviation|Mean
2750000|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.|||U/L||Standard Deviation|Mean
2750001|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2750002|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2750003|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2750004|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2750005|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
2750006|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.|||g/dL||Standard Deviation|Mean
2750270|NCT00874770|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12|cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12|At Week 12|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2750009|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 12 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for AST at baseline and at month 12.|||U/L||Standard Deviation|Mean
2750010|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 12 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for ALT at baseline and at month 12.|||U/L||Standard Deviation|Mean
2750011|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2750012|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2750013|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2750014|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2750015|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
2750016|NCT00876733|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline.|The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.|||cells/mm^3||Standard Deviation|Mean
2750017|NCT00876733|Secondary|Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.|The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 12 months|Patients from FAS with values for CD4+ at baseline and after 12 months.|||cells/mm^3||Standard Deviation|Mean
2750018|NCT00876733|Secondary|Changes in the Viral Load After 36 Months From Baseline.|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.|||Log10 copies/ml||Standard Deviation|Mean
2750019|NCT00876733|Secondary|Changes in the Viral Load After 12 Months From Baseline.|The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 12 months|Patients from FAS with values for viral load at baseline and after 12 months.|||Log10 copies/ml||Standard Deviation|Mean
2750020|NCT00876733|Primary|Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs|Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.|||participants|||Number
2750021|NCT00876694|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks|Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.|After 12, 24 and 52 weeks|The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug.|||Liters||Standard Error|Least Squares Mean
2750022|NCT00876694|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.|||mmol/L||Standard Error|Least Squares Mean
2750023|NCT00876694|Primary|Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.|||mmol/L||Standard Error|Least Squares Mean
2750024|NCT00876694|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.~The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).~Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
2750025|NCT00876694|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.~A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
2750026|NCT00876694|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.~A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
2750027|NCT00876694|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment|The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
2750028|NCT00876460|Secondary|Cmax of Docetaxel in Course 2|"Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.~Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2750029|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 2|"AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.~Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2750030|NCT00876460|Secondary|Cmax of Docetaxel in Course 1|Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2750031|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2750032|NCT00876460|Secondary|Cmax of Nintedanib in Course 1|Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1|-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2750033|NCT00876460|Secondary|AUC0-inf of Nintedanib in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1|-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2750034|NCT00876460|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set|||Participants|||Number
2750035|NCT00876460|Secondary|Time to Treatment Failure (TTF)|"For participants with known date of discontinuation of the study treatment (or progression [not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression] or death): TTF [days] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1.~For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) [days] = date when the patient is known to be progression-free and alive - date the study treatment started + 1.~Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set|||Days||95% Confidence Interval|Median
2750036|NCT00876460|Secondary|Progression-Free Survival (PFS)|"For participants with known date of progression or death (of any cause): PFS [days] = earlier of date of progression or death - date the study treatment started + 1.~For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) [days] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1.~Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set|||Days||95% Confidence Interval|Median
2750037|NCT00876460|Secondary|Disease Control|Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image|||Participants|||Number
2750038|NCT00876460|Secondary|Objective Tumor Response|Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image|||Participants|||Number
2750039|NCT00876460|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)."|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set|||Participants|||Number
2750040|NCT00876460|Primary|Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel|"Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel.~Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) <1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT."|During the first treatment course, up to 3 weeks|Treated set (Patients eligible for DLT confirmation)|||Participants|||Number
2750041|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
2750042|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
2750043|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
2750044|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
2750045|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
2750046|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2750047|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2750048|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2750049|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2750050|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
2750051|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2750061|NCT00876395|Secondary|Overall Response (OR) - HR-negative Population|OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline|||Percentage of participants|||Number
2750052|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2750053|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2750054|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2750055|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
2750056|NCT00876395|Secondary|Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population|Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.|up to about 56 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline|||months||95% Confidence Interval|Median
2750057|NCT00876395|Secondary|Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population|Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.|up to about 56 months|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.|||months||95% Confidence Interval|Median
2750058|NCT00876395|Secondary|Trastuzumab Serum Concentrations|Blood levels at steady states for everolimus/placebo|Cycle 4/Day 1 (Pre-infusion and end of infusion)|Safety Set: consists of all patients who received at least 1 dose of study treatment & have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment.|||microgram/ml||Standard Deviation|Mean
2750059|NCT00876395|Secondary|Paclitaxel Plasma Concentrations|Blood levels at steady states for everolimus/placebo|Cycle 2/Day 15 (Pre-infusion and end of infusion)|Safety Set: consists of all patients who received at least 1 dose of study treatment & have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment.|||ng/mL||Standard Deviation|Mean
2750060|NCT00876395|Secondary|Everolimus Blood Level Concentrations at Steady States for Everolimus|Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days|predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22|Safety Set: consists of all patients who received at least 1 dose of study treatment & have at least 1 valid post-baseline safety assessment. Patients were analyzed according to the treatment actually received. If patient took at least 1 dose of treatment to which he/she was randomized then the treatment actually received was the rand. treatment.|||ng/mL||Standard Deviation|Mean
2750062|NCT00876395|Secondary|Overall Response (OR) - Full Population|OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months||||Percentage of participants|||Number
2750063|NCT00876395|Secondary|Time to Overall Response Based on Investigator - HR-negative Population|Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline|||months||95% Confidence Interval|Median
2750064|NCT00876395|Secondary|Time to Overall Response Based on Investigator - Full Population|Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.|||months||95% Confidence Interval|Median
2750065|NCT00876395|Secondary|Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population|CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline|||Percentage of participants||95% Confidence Interval|Number
2750066|NCT00876395|Secondary|Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population|CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.|||Percentage of participants||95% Confidence Interval|Number
2750067|NCT00876395|Secondary|Overall Response Rate (ORR) - HR-negative Population|ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline|||Percentage of participants||95% Confidence Interval|Number
2750068|NCT00876395|Secondary|Overall Response Rate (ORR) - Full Population|ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.|up to about 23 months|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.|||Percentage of participants||95% Confidence Interval|Number
2750069|NCT00876395|Secondary|Overall Survival (OS) - HR-negative Population|OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population.|up to about 76 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline. Due to the exploratory nature of the OS analysis, OS was not statistically tested.|||Months||95% Confidence Interval|Median
2750070|NCT00876395|Secondary|Overall Survival (OS) - Full Population|OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population.|up to about 76 months|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization. Due to the exploratory nature of the OS analysis, OS was not statistically tested|||Months||95% Confidence Interval|Median
2750071|NCT00876395|Primary|Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population|PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population.|date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months|HR-negative Full Analysis Set (HR-negative FAS) consists of subset of patients from the FAS population with HR-negative status at Baseline.|||Months||95% Confidence Interval|Median
2750210|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||hours||Full Range|Median
2750072|NCT00876395|Primary|Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population|PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.|date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle patients will be analyzed according to the treatment and stratum they were assigned to at randomization.|||months||95% Confidence Interval|Median
2750073|NCT00876343|Secondary|Mean Change in Sheehan Disability Scale (SDISS)|"The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.~The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired)."|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration||||Rating score||Standard Error|Mean
2750074|NCT00876343|Secondary|MADRS Response Rate|The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration||||percentage of subjects|||Number
2750075|NCT00876343|Primary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration||||Rating score||Standard Error|Mean
2750076|NCT00876265|Primary|Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12.|The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.|Baseline and Week 12 of follow-up|The Full Analysis Set (FAS) population was the analysis population which was defined as all subjects who were randomized and received at least one injection of the study device to the nasolabial folds.|||Wrinkle Severity Rating Score (SRS)||Standard Error|Least Squares Mean
2750077|NCT00876200|Secondary|Genetic Study: Characterization of Deletions Responsible for WBS (Size Deletion, DNA Sample at Inclusion).||Day 0|||||||
2750078|NCT00876200|Secondary|Effect of Minoxidil on Neurohumoral Mechanisms of Cardiovascular Regulation and on Plasmatic Markers of the Extracellular Matrix.||12 months|||||||
2750079|NCT00876200|Secondary|Efficacy of Minoxidil on Arterial Tension (24H-Holter at J0 and M12)||12 months|||||||
2750080|NCT00876200|Secondary|Efficacy of Minoxidil on Supravalvular Stenosis, Pulmonary Stenosis, Aortic Stenosis and Renal Stenosis (Cardiac and Renal Echodoppler at J0, and M12)||12 months|||||||
2750081|NCT00876200|Secondary|Efficacy of Minoxidil on Arterial Stiffness (Pulse Wave Velocity and Vascular Compliance at J0, M12 and M18)||18 months|||||||
2750082|NCT00876200|Secondary|Efficacy of Minoxidil on Humeral IMT Assessed by Vascular Echography||18 months|||||||
2750083|NCT00876200|Primary|Variation of Carotid Intima-media Thickness (IMT) Assessed by Vascular Echography||12 months||||mm||95% Confidence Interval|Mean
2750084|NCT00876018|Secondary|Change From Baseline in Vitamin C Level After 4 Months|Vitamin C level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||miligram per decilitre (mg/dL)||Inter-Quartile Range|Median
2750085|NCT00876018|Secondary|Change From Baseline in Folate Level After 4 Months|Folate level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||nanogram per mililitre (ng/mL)||Inter-Quartile Range|Median
2750086|NCT00876018|Secondary|Change From Baseline in Vitamin B12 Level After 4 Months|Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||picomole per litre(pmol/L)||Inter-Quartile Range|Median
2750087|NCT00876018|Secondary|Change From Baseline in Vitamin B6 Level After 4 Months|Vitamin B6 level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||nano mole per litre (nmol/L)||Inter-Quartile Range|Median
2750088|NCT00876018|Secondary|Change From Baseline in Vitamin B2 Level After 4 Months|Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||ratio||Inter-Quartile Range|Median
2750089|NCT00876018|Secondary|Change From Baseline in C-reactive Protein Level After 4 Months|C-reactive protein level was measured.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||mg/L||Inter-Quartile Range|Median
2750090|NCT00876018|Secondary|Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months|Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||miligram per litre (mg/L)||Inter-Quartile Range|Median
2750091|NCT00876018|Secondary|Change From Baseline in Ferritin Level After 4 Months|Ferritin level was measured to assess the iron status of study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||nanogram per mililitre (ng/mL)||Inter-Quartile Range|Median
2750092|NCT00876018|Secondary|Change From Baseline in Hemoglobin Level After 4 Months|Hemoglobin level was measured to assess the iron status in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||gram per decilitre (g/dl)||Inter-Quartile Range|Median
2750093|NCT00876018|Secondary|Change From Baseline in Rate of Decline of Muscle Strength After 4 Months|Rate of decline of muscle strength was assessed to measure the muscle endurance of forearm. Sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm. The participant was required to sustain a maximal contraction until the force dropped to 50% of its maximal value. Rate of decline of muscle strength was calculated as 50 percent of maximal value of contraction divided by time to fatigue (50%maximal value of contraction (MVC)/Time to fatigue).|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||kg/sec||Standard Deviation|Mean
2750094|NCT00876018|Secondary|Change From Baseline in Time to Fatigue After 4 Months|Time to fatigue is defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value. Time to fatigue was measured using Jamar hand dynamometer to assess the muscle strength. In this test, participants were required to sustain a maximal contraction until the force dropped to 50% of its maximal value.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||sec||Standard Deviation|Mean
2750095|NCT00876018|Secondary|Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months|Maximal handgrip strength was measured using a Jamar handgrip dynamometer in dominant and non-dominant arms. The width of the grip was noted during the pre-intervention assessment and kept constant for an individual during the subsequent post-intervention assessment. Muscle strength was recorded as the best (highest) value for the dominant and non-dominant sides as well as average value of the 3 measurements.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||kg||Standard Deviation|Mean
2750096|NCT00876018|Primary|Change From Baseline in Visual Reaction Time After 4 Months|Visual reaction time was assessed using a customized computer based programme. Participant was provided with a periodic random test visual stimulus among many other 'non test' stimuli. Participant was required to tap the space bar of the computer as fast as possible on the appearance of the test visual stimulus. Three test visual cues were provided at each sitting to allow for training effects. The shortest visual reaction time of the three visual cues was used in analyses.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||milliseconds (msec)||Standard Deviation|Mean
2750097|NCT00876018|Primary|Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months|A 40m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch. The moment any part of the designated participant's body reached the marker level, the corresponding examiner stopped their watches and recorded the time for the sprint.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||seconds (Sec)||Standard Deviation|Mean
2750098|NCT00876018|Primary|Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months|Aerobic capacity(VO2peak) is defined as maximum rate of oxygen consumption attained on a particular exercise test. VO2peak was measured by 20m shuttle run test to assess aerobic & whole body endurance. In this test, participants were asked to move around one cone to another placed at 19m distance, reversing direction & in accordance with a pace dictated by sound signal, that got progressively faster at one minute intervals. The initial pace was set at 4.0 km/hr & with subsequent increases of 0.5 km/hr every subsequent minute. This test was conducted in groups (of at least 3 children per group). The shuttle was stopped when either the participant chose to stop because of exhaustion or when participant was > 1m away from cone at 2 consecutive paced signals. The number of shuttles at stoppage was noted. VO2peak was calculated as 31.025 + (3.325 x speed) - (3.248 x age). Speed is speed attained in previous level of shuttle, computed as speed (km/hr) = v + 0.5 x n/60; and age is in years.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||km/hr*years||Standard Deviation|Mean
2750185|NCT00875524|Primary|Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period|Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.|Year 1, Year 2, Year 3 and Year 4 after the Third Injection|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.|||Percentage of participants|||Number
2750099|NCT00876018|Primary|Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months|Maximal aerobic capacity (VO2max) is defined as the maximum rate of oxygen consumption, measured during incremental exercise. VO2max was measured with the help of an externally placed 12-inch step test to assess the aerobic fitness/cardio-respiratory endurance of the study participants. In this test, participants were asked to step at 22 steps a minute for 3 minutes. The pulse rate was recorded manually, within 15sec of stopping the test. VO2max was calculated as (VO2 x HRmax) divided by HR observed, where HRmax = 220-Age in years. HRmax= maximum heart rate. VO2 is equal to (0.2 x Stepping Rate) + (2.4 x Step height x Stepping Rate) + 3.5 mL/kg/min. mL/kg/min.= milliliter per kilogram per minute.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||mL/kg/min.||Standard Deviation|Mean
2750100|NCT00875979|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival was defined as the time from randomization to first documented disease progression (PD) or death due to any cause within 30 days of the last treatment, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients.|||Months||95% Confidence Interval|Median
2750101|NCT00875979|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to disease progression (PD) or death from any cause. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease. Only patients with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2750102|NCT00875979|Primary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease.|||Percentage of patients||95% Confidence Interval|Number
2750103|NCT00875836|Secondary|Marijuana Craving|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.|8 Weeks||||units on a scale||95% Confidence Interval|Mean
2750104|NCT00875836|Secondary|Retention in the Study|Number of days subjects remained active in the study|participants were followed for twelve weeks||||Day||Inter-Quartile Range|Median
2750105|NCT00875836|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|Participants provided a once-weekly urine sample for twelve weeks||||percentage of UDS|Participants||Number
2750106|NCT00875810|Secondary|Intervertebral Disc Space||2 years|As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.|||millimiters||Standard Deviation|Mean
2750107|NCT00875810|Primary|Neck Disability Index (NDI) Score|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).~The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.~NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation."|2 years|As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.|||units on a scale||Standard Deviation|Mean
2750108|NCT00875810|Secondary|Duration of Pain Prior to Enrollment|Documentation of duration of pain prior to enrollment|Baseline visit||||percentage of patients with pain|||Number
2750211|NCT00875433|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2750109|NCT00875810|Primary|EQ-5D|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).~EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by no problem in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death."|2 years|As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.|||units on a scale||Standard Deviation|Mean
2750110|NCT00875797|Secondary|6-month Survival|Six month follow up|6 month||||participants|||Number
2750111|NCT00875797|Secondary|Infection Rate at Participants in Both Groups|Number of infections that occured at participants during study.|participants were followed for the duration of ICU stay (average 3 weeks)||||number of infections|||Number
2750112|NCT00875797|Primary|Intestinal Permeability - Lactulose-mannitol(L/M)Test|"Measurement of intestinal permeability using lactulose-mannitol test (L/M test).~Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract.~Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut.~Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations.~Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated."|4 days after admission to intensive care unit||||L/M ratio||Standard Deviation|Mean
2750113|NCT00875706|Primary|Number of Participants in Pilot Interviews|This outcome measures the number of participants that participated in interviews that were conducted during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Interview group were analyzed for this outcome. The population included trainees and direct care workers.|||participants|||Number
2750114|NCT00875706|Primary|Number of Participants in Pilot Surveys|This outcome measures the number of participants that completed the survey during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Survey group were analyzed for this outcome. The population included trainees and direct care workers.|||participants|||Number
2750115|NCT00875706|Primary|Facility Implementation of Trainings|This measure assesses the number of participating facilities (4) that implemented trainings in their own facilities upon completion of our educational training intervention.|This outcome was assessed at the end of the 1 year pilot study.|This unit of measure for this outcome measure is at the facility level. There were 4 facilities (8 trainees) in total that began the training intervention.|||Facility|Participants||Number
2750116|NCT00875706|Primary|Completion of Training Intervention|This outcome measures the number of participants that fully completed the training intervention.|This outcome was assessed at the end of the 1 year pilot study.|The analysis population includes only participants who started the Train-the-Trainer intervention and therefore only participants in the Training Feasibility Arm/Group were analyzed for this outcome.|||participants|||Number
2750117|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750118|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750154|NCT00875667|Secondary|Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis|Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.|From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm|ITT population includes all randomized participants.|||Weeks||95% Confidence Interval|Median
2750119|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Scale was scored between 0 and 100, with a higher score representing a higher quality of life.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750120|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain was scored between 0 and 100, with a higher score representing a higher quality of life.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750121|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750122|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750123|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750124|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750125|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2752002|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 2|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 2|FAS (LOCF)|||participants|||Number
2750126|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain was scored between 0 and 100, with a high score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750127|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale was scored between 0 and 100, with a high score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750128|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750129|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit|"The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Diarhoea Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Least Squares Mean
2750130|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarhoea Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750131|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750132|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Constipation|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Domain was scored between 0 and 100, with a high score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750212|NCT00875433|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2750133|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Scale was scored between 0 and 100, with a high score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750134|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750135|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750136|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750137|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750138|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750139|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750213|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.|||hours||Full Range|Median
2750140|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750141|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750142|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750143|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750144|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750145|NCT00875667|Secondary|Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750155|NCT00875667|Secondary|Kaplan Meier Estimate of Time to Progression According to the IRC Central Review|Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.|From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm|ITT population includes all randomized participants.|||Weeks||95% Confidence Interval|Median
2750146|NCT00875667|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.|Health Related Quality of Life (QoL) Evaluable Population includes participants who had evaluable QoL assessments.|||units on a scale||Standard Deviation|Mean
2750147|NCT00875667|Secondary|Number of Participants With Treatment Emergent Adverse Events|Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A Treatment Emergent Adverse event (TEAE) is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|From the date of the first dose of study drug to 28 days after the last dose, up to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigators choice arm|The safety population included participants who received at least one dose of study drug (either lenalidomide or investigator's choice).|||Participants|||Count of Participants
2750148|NCT00875667|Secondary|Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis|Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive.|From randomization to progression of disease or death; up to the study discontinuation date of 09 October 2018; overall median follow-up time was 285 weeks|ITT population included all randomized participants.|||weeks||95% Confidence Interval|Median
2750149|NCT00875667|Secondary|Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review|Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive.|From date of randomization to the data cut-off date of 07 March 2014; overall median follow-up was 93.9 weeks|ITT population included all randomized participants.|||weeks||95% Confidence Interval|Median
2750150|NCT00875667|Secondary|Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis|Time to first response was defined as the time from first dose of study drug to the date of the first response (having at least a PR). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the subject was known to be progression-free.|From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm|ITT population includes all randomized participants.|||Weeks||95% Confidence Interval|Median
2750151|NCT00875667|Secondary|Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review|Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. ). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the participant was known to be progression-free.|From randomization of study drug to time of first documented PR or better response; up to data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm|ITT population includes all randomized participants.|||Weeks||95% Confidence Interval|Median
2750152|NCT00875667|Secondary|Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis|Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake.|From date of first dose of treatment to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm|Includes all treated participants.|||weeks||95% Confidence Interval|Median
2750153|NCT00875667|Secondary|Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator|Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake.|From the date of the first treatment to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm|Includes all treated participants.|||weeks||95% Confidence Interval|Median
2750183|NCT00875524|Primary|Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine|Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: >=37.5 degree Celsius (°C) to <=38.0°C, Grade 2: >38.0°C to <=39.0°C, Grade 3: >39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.|14 days post-each injection|Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.|||Percentage of participants|||Number
2750156|NCT00875667|Secondary|Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis|Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease.|From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm|ITT population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2750157|NCT00875667|Secondary|Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review|Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease.|From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm|ITT population includes all randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2750158|NCT00875667|Secondary|Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis|Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.|From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm|The analysis population included participants with an overall response.|||Weeks||95% Confidence Interval|Median
2750159|NCT00875667|Secondary|Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review|Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.|From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm|The analysis population included participants with an overall response.|||Weeks||95% Confidence Interval|Median
2750160|NCT00875667|Secondary|Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.|From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm|ITT population included all randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2750161|NCT00875667|Secondary|Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who discontinued before any response had been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.|From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm|ITT population included all randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2750186|NCT00875524|Primary|Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine|Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.|Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3|Analysis was performed on PPA set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2750162|NCT00875667|Primary|Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis|Kaplan Meier estimates of PFS were defined as the time from randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last completed assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks|ITT population included all randomized participants.|||weeks||95% Confidence Interval|Median
2750163|NCT00875667|Primary|Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review|PFS was defined as time of randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks|ITT population included all randomized participants.|||weeks||95% Confidence Interval|Median
2750164|NCT00875641|Secondary|Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|60 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750165|NCT00875641|Secondary|Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|30 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750166|NCT00875641|Secondary|Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|7 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750167|NCT00875641|Secondary|Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|60 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750168|NCT00875641|Secondary|Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|60 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750169|NCT00875641|Secondary|Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|60 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750209|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,AUC)|R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2750170|NCT00875641|Primary|Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|30 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750171|NCT00875641|Primary|Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|7 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750172|NCT00875641|Primary|Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts|Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).|60 days following each vaccination|Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare & WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control & Recent Historical Control cohorts were defined.|||Incidences/Person-Month||95% Confidence Interval|Number
2750173|NCT00875615|Secondary|Number of Patients Achieving Clinical Benefit|Number of patients achieving complete or partial response according to RECIST criteria|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.|||participants|||Number
2750174|NCT00875615|Primary|Number of Subjects Experiencing Adverse Events|The number of subjects experiencing adverse events after receiving protocol therapy.|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.|||participants|||Number
2750175|NCT00875589|Primary|Stability of Fixation|The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.|During eye movement recording session (20 sec).|Although there were 15 participants in the Control arm, data were only analyzed for a cohort of 11 that were age-matched to the MTBI arm participants.|||degrees||Standard Deviation|Mean
2750176|NCT00875563|Primary|Number of Participants With Treatment Success|"Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm.~A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair.~A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis."|6 months|Two patients were lost to follow-up and did not have CT data at 6 months. Patients treated with the Zenith® Fenestrated AAA Endovascular Graft was compared to propensity score matched patients treated with the Zenith® AAA Endovascular Graft (NCT00196092, link to 5-year study results provided).|||participants|||Number
2750177|NCT00875550|Secondary|Time to Successful Extubation||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Hours||95% Confidence Interval|Median
2750178|NCT00875550|Secondary|Time to First Dose of Rescue Medication for Sedation and Analgesia||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Hours||95% Confidence Interval|Median
2750179|NCT00875550|Secondary|Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Milligram||Standard Deviation|Mean
2750180|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||hours||Full Range|Median
2750181|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Hours||Full Range|Median
2750182|NCT00875550|Primary|Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.|"Clinical Score Level of Sedation 0 Awake/Alert~Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.~Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.~Deeply sedated: Deep sleep, arousable only with significant physical stimulation.~Unarousable"|6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Percentage of subjects|||Number
2750184|NCT00875524|Primary|Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine|Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >= 5 cm.|7 days post-each injection|Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.|||Percentage of participants|||Number
2750187|NCT00875524|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period|GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.|Year 1, Year 2, Year 3 and Year 4 after the Third Injection|Analysis was performed on Full analysis set which included all the participants present at first vaccination (V01) and received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for each specified category.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2750188|NCT00875524|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine|Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).|Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3|Analysis was performed on Per-protocol analysis (PPA) set which included participants who received at least 1 dose of the study vaccine and had no protocol deviations, randomization error, blood sample not taken within the period and forbidden treatments. Here, 'number analyzed' = participants with available data for each specified category.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2750189|NCT00875485|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|One month after the administration of the challenge dose (Month 0 to Month 1)|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750190|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750191|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750192|NCT00875485|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2750193|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750194|NCT00875485|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750195|NCT00875485|Secondary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2750196|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value.|"Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).~Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose."|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750197|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 15.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||Subjects|||Number
2750198|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 14.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||Subjects|||Number
2750199|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 13.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||subjects|||Number
2750200|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 12.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||subjects|||Number
2750201|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 11.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||subjects|||Number
2750202|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.|Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points.|||subjects|||Number
2750203|NCT00875485|Primary|Anti-HBs Anamnestic Response.|"Anamnestic response was defined as:~Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points.~At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
2750204|NCT00875485|Primary|Anti-HBs Antibody Concentrations|"Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.~Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA."|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.|Analysis was performes on subjects from the Long Term According-to-Protocol (LT ATP) cohort forimmunogenicity on anti-HBs seropositive subjects with available data at the specified time-points.|||mIU/mL||95% Confidence Interval|Geometric Mean
2750205|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||Subjects|||Number
2750206|NCT00875485|Primary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on anti-HAV seropositive subjects with available data at the specified time-points.|||mIU/mL||95% Confidence Interval|Geometric Mean
2750207|NCT00875433|Secondary|Percentage Peak Trough Fluctuation (PTF)|PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||percentage of peak trough fluctuation||Geometric Coefficient of Variation|Geometric Mean
2750208|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,Cmax)|R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2750215|NCT00875433|Secondary|Area Under Curve 0-24 Hours (AUC0-24) on Day 1|AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2750216|NCT00875433|Secondary|Highest CTC Grade for Adverse Events|Highest Common Terminology Criteria (CTC) grade for adverse events|First administration of trial medication until 28 days after last administration of trial medication|All patients from TS with adverse events|||Participants|||Number
2750217|NCT00875433|Secondary|Average Time-matched Heart Rate Change From Baseline to Day 14.|Average time-matched heart rate change from baseline to day 14.|The day before the first drug dose (baseline) and the day 14.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.|||bpm||Standard Error|Mean
2750218|NCT00875433|Secondary|Patients With Notable Findings in QT on Day 14|Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms.|Day 14|All patients from TS with data for QTcF on day 14|||Participants|||Number
2750219|NCT00875433|Secondary|Average Time-matched QT Change From Baseline to Day 14|Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.|||ms||Standard Error|Mean
2750220|NCT00875433|Secondary|Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point|Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model.|Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )|All patients in TS who had at least 1 time-matched pair of QT measurements available from either Day1 or Day 14 of treatment.|||ms||Standard Error|Mean
2750221|NCT00875433|Secondary|Patients With Clinically Relevant Findings in ECG on Day 14|Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14.|Day 14|All patients from TS with data for ECG on day 14|||Participants|||Number
2750222|NCT00875433|Secondary|Patients With Notable Findings in QTcF on Day 14|Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms.|Day 14|All patients from TS with data for QTcF on day 14|||Participants|||Number
2750223|NCT00875433|Secondary|Duration of Disease Control (DC)|Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.|||weeks||95% Confidence Interval|Median
2750224|NCT00875433|Secondary|Disease Control|Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.|||Participants|||Number
2750225|NCT00875433|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as time from start of treatment to death.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.|||weeks||95% Confidence Interval|Median
2750226|NCT00875433|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from TS who progressed or died.|||weeks||95% Confidence Interval|Median
2750227|NCT00875433|Primary|Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14|Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.|||ms||Standard Error|Mean
2750228|NCT00875433|Primary|Objective Response (OR)|OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.|||Participants with OR|||Number
2750229|NCT00875420|Primary|Percent Change in Composite Score Over Time|Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.|||Percent change from baseline||Standard Deviation|Mean
2750230|NCT00875420|Secondary|Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.|Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.|||Percent change from baseline||Standard Deviation|Mean
2750231|NCT00875420|Secondary|Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.|Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.|||Percent change from baseline||Standard Deviation|Mean
2750232|NCT00875420|Primary|Percent Change in Frequency of Hot Flashes Over Time|Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.|||Percent change from baseline||Standard Deviation|Mean
2750233|NCT00875394|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 weeks|Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.||||||
2750234|NCT00875329|Primary|Responses From the TBI Clinical Reminder|The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.|April 2007 January 2012||||percentage of participants|||Number
2750235|NCT00875277|Secondary|Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses|"Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study.~In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections."|At end of treatment|Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.|||cells/mm^2||Standard Deviation|Mean
2750236|NCT00875277|Secondary|Pathology and Histology by Treatment: Epidermal Thickness|Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections..|At end of treatment|Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.|||µm||Standard Deviation|Mean
2750237|NCT00875277|Secondary|Pathology and Histology by Treatment|"Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:~Morphology of epidermis~Stratum corneum (semi (extent of))~Stratum granulosum (semi (extent of))~Parakeratosis (semi (extent of))~Infiltration of inflammatory cells (semi (extent of))"|At end of treatment|Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.|||score on a scale||Standard Deviation|Mean
2750238|NCT00875277|Secondary|Biomarkers by Immunochemistry: Epidermal Proliferation|"3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.~By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker."|At end of treatment|Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.|||cells/mm^2||Standard Deviation|Mean
2750239|NCT00875277|Secondary|Biomarkers by Immunochemistry: Epidermal Differentiation|3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.|At end of treatment|Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.|||%, positive area/total area||Standard Deviation|Mean
2750240|NCT00875277|Secondary|Biomarkers by Immunochemistry|"3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.~Cells counted per mm^2 were cells that were positive for the indicated biomarker."|At end of treatment|Since biopsies were only taken from three out of six sites, not all treatment-block combinations were available.|||cells/mm^2||Standard Deviation|Mean
2750241|NCT00875277|Secondary|Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound|The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment.|At Day 8, Day 15, Day 22 and end of treatment|The 24 participants that were randomized received all products distributed on six different test sites on the body.|||mm||Standard Deviation|Mean
2750242|NCT00875277|Secondary|Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline|"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration~The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)."|At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25||||score on a scale||Standard Deviation|Mean
2750243|NCT00875277|Secondary|Change in Infiltration Compared to Baseline|"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration"|At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25|The 24 participants that were randomized received all products distributed on six different test sites on the body.|||units on a scale||Standard Deviation|Mean
2750244|NCT00875277|Secondary|Change in Scaling Compared to Baseline|"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales"|At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25|The 24 participants that were randomized received all products distributed on six different test sites on the body.|||units on a scale||Standard Deviation|Mean
2750245|NCT00875277|Secondary|Change in Erythema Compared to Baseline|"The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.~The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red"|At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25|The 24 participants that were randomized received all products distributed on six different test sites on the body.|||units on a scale||Standard Deviation|Mean
2750246|NCT00875277|Secondary|Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline|"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)."|From baseline (Day 1) to end of treatment (Day 29)|The 24 participants that were randomized received all products distributed on six different test sites on the body.|||score on a scale||Standard Deviation|Mean
2750247|NCT00875277|Primary|Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)|"The (sub)investigator made the following clinical assessments by use of the scale below:~Score; Intensity; Description~Erythema:~0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red~Scaling:~0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales~Infiltration:~0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration~The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe)."|From baseline (Day 1) to end of treatment (Day 29)|The 24 participants that were randomized received all products distributed on six different test sites on the body.|||score on a scale||Standard Deviation|Mean
2750248|NCT00875212|Primary|Minimum pH After 14 Days of Use of Dentifrice|measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).|14 days|The initial part of the work as a pilot study.|||pH||Standard Deviation|Mean
2750249|NCT00875212|Primary|Minimum pH|The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.|at 1 minute (minimum fermenting pH) or at 7 minutes|The number of subjects were determined by a pilot study carried out in 3 volunteers. The study has a crossover design. Thus the 4 groups of dentifrices tested included the same subjects in a different time-measurement avoiding the influence of individual variables in the analysis.|||pH||Standard Deviation|Mean
2750250|NCT00875017|Secondary|Net Calcium Absorption|"Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting).~Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting).~Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting)."|10 hours post-dose|PD set|||mg||Standard Error|Least Squares Mean
2750251|NCT00875017|Secondary|Net Phosphorous Binding|"Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only.~Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only."|10 hours post-dose|PD set|||mg||Standard Error|Least Squares Mean
2750252|NCT00875017|Primary|Net Phosphorous Absorption|"Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting).~Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting).~Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting)."|10 hours post-dose|Pharmacodynamic Set (PD) consists of subjects who provided all rectal effluent collections and completed all treatment periods. Subjects who vomited during any of the treatment periods were excluded from the PD set.|||mg||Standard Error|Least Squares Mean
2750253|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
2750254|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
2750255|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
2750256|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
2750257|NCT00874887|Secondary|Minimum Inhibitory Concentration (MIC) Range at Day 14|MIC range at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. The MIC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
2750258|NCT00874887|Secondary|Minimum Inhibitory Concentration 90 (MIC90) at Day 14|The Minimum Inhibitory Concentration 90 (MIC90) is the minimum concentration required to inhibit the growth of 90% of microorganisms. The MIC90 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
2750259|NCT00874887|Secondary|Minimum Inhibitory Concentration 50 (MIC50) at Day 14|The Minimum Inhibitory Concentration 50 (MIC50) is the minimum concentration required to inhibit the growth of 50% of microorganisms. The MIC50 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
2750260|NCT00874887|Secondary|Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14|Mutant Prevention Concentration (MPC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MPC is the lowest drug concentration which prevents growth of any colony of bacteria on the conjunctiva. The MPC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
2750261|NCT00874887|Primary|Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14|Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. One patient in the Zymar® group did not have cultures performed at Day 14.|||Percentage of Subjects|||Number
2750262|NCT00874848|Secondary|Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review|"Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.~If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date."|From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||months||95% Confidence Interval|Median
2750271|NCT00874770|Secondary|Percentage of Participants With Early Virologic Response (EVR) at Week 12|EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.|At Week 12|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2750263|NCT00874848|Secondary|Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review|"The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||months||95% Confidence Interval|Median
2750264|NCT00874848|Secondary|Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review|"The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||participants|||Number
2750265|NCT00874848|Secondary|Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review|"The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||participants|||Number
2750266|NCT00874848|Secondary|Overall Survival (OS) in Each Study Arm Based on the Safety Population|Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.|From the time of randomization to death, subject being lost to follow-up or study completion|The safety population comprised all randomized subjects who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.|||months||95% Confidence Interval|Median
2750267|NCT00874848|Primary|Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review|"Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||participants|||Number
2750268|NCT00874822|Primary|Obstructive Sleep Apnea|The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.|9 Months||||participants|||Number
2750269|NCT00874770|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.|From screening up to Week 12 (treatment period)|All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point|||participants|||Number
2750272|NCT00874770|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.|At Week 4|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2750273|NCT00874770|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12|eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.|A Weeks 4 and 12|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2750274|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From Day 31 up to Week 24 of post treatment follow-up|All participants who received at least 1 dose of study drug. n=evaluable patients|||participants|||Number
2750275|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug|All participants who received at least 1 dose of study drug.|||participants|||Number
2750276|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 24 Hours|The mean change from baseline (CFB) in QTcF at 24 hours post-dose was assessed. At baseline (pre-dose) and at 24 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 24 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation). Further, CFB data are excluded from the placebo arm for missing data (N=1) and study discontinuation (N=1).|||msec||95% Confidence Interval|Mean
2750277|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 10 Hours|The mean change from baseline (CFB) in QTcF at 10 hours post-dose was assessed. At baseline (pre-dose) and at 10 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 10 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation).|||msec||95% Confidence Interval|Mean
2750278|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 8 Hours|The mean change from baseline (CFB) in QTcF at 8 hours post-dose was assessed. At baseline (pre-dose) and at 8 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 8 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation).|||msec||95% Confidence Interval|Mean
2750279|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 6 Hours|The mean change from baseline (CFB) in QTcF at 6 hours post-dose was assessed. At baseline (pre-dose) and at 6 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 6 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation).|||msec||95% Confidence Interval|Mean
2750287|NCT00874614|Secondary|Overall Survival|Duration of overall survival was calculated from the date of first therapeutic dose of AZEDRA® to death, or at the last date the patient was known to be alive. Results are presented per December 2017 data-cut. Survival was censored at the end of the 5-year long-term follow-up period, thus the upper limit of the confidence interval reported below for two therapeutic doses is actually >60 months.|Up to 5 Years (60 months)||||months||95% Confidence Interval|Median
2750280|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 4 Hours|The mean change from baseline (CFB) in QTcF at 4 hours post-dose was assessed. At baseline (pre-dose) and at 4 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 4 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation).|||msec||95% Confidence Interval|Mean
2750281|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 3 Hours|The mean change from baseline (CFB) in QTcF at 3 hours post-dose was assessed. At baseline (pre-dose) and at 3 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 3 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation). Further, CFB data are excluded from the placebo arm for missing data (N=1).|||msec||95% Confidence Interval|Mean
2750282|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 2 Hours|The mean change from baseline (CFB) in QTcF at 2 hours post-dose was assessed. At baseline (pre-dose) and at 2 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 2 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation). Further, CFB data are excluded from the placebo arm for missing data (N=1).|||msec||95% Confidence Interval|Mean
2750283|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 1 Hour|The mean change from baseline (CFB) in QTcF at 1 hour post-dose was assessed. At baseline (pre-dose) and at 1 hour post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 1 hour post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation).|||msec||95% Confidence Interval|Mean
2750284|NCT00874731|Secondary|Number of Participants Discontinuing Study Treatment Due to an Adverse Event|The number of participants discontinuing study treatment due to an AE was assessed. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Participants discontinuing study treatment due to an AE were counted as discontinuing under the treatment they received when the AE occurred.|Up to 6 months|All participants receiving ≥1 dose of study treatment. One participant discontinued from study after the Day 1 placebo dose and did not receive ridaforolimus 100 mg or 40 mg.|||Participants|||Count of Participants
2750285|NCT00874731|Secondary|Number of Participants Experiencing an Adverse Event (AE)|"The number of participants experiencing an AE was assessed. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Participants experiencing AEs were counted under the treatment they received when the AE occurred. Participants experiencing AEs during the washout period between Part 1 and Part 2 are counted in the Pt 1, Day 2. Ridaforolimus 100 mg arm."|Up to 7 months|All participants receiving ≥1 dose of study treatment. The washout period following Part 1 was the safety follow-up period for Part 1. For this reason, AEs that occurred during the washout period are appropriately included as Part 1 AEs. One participant discontinued after the Day 1 placebo dose and did not receive ridaforolimus 100 mg or 40 mg.|||Participants|||Count of Participants
2750286|NCT00874731|Primary|Part 1. Mean Change From Baseline in Rate-Corrected (Fridericia's) QT Interval (QTcF) at 0.5 Hours|The mean change from baseline (CFB) in QTcF at 0.5 hours post-dose was assessed. At baseline (pre-dose) and at 0.5 hours post-dose, 5 replicate electrocardiograms (ECGs) were collected to reduce measurement variability. The 5 replicate QTcF values were averaged to calculate the QTcF value for each participant. Further, each participant served as their own control for the calculation of CFB in QTcF after placebo and ridaforolimus 100 mg dosing. Additionally, CFB in QTcF after single ridaforolimus 100 mg dosing for each participant was adjusted for the CFB in QTcF observed after placebo dosing.|Baseline and 0.5 hours post-dose on Days 1 & 2 of Part 1|Includes only participants in Part 1 receiving treatment. QTcF not analyzed in Part 2. QTcF data are excluded from: 1) both arms (N=1; non-evaluable ECG waveform); and 2) ridaforolimus arm (N=2; protocol violation & study discontinuation).|||milliseconds (msec)||95% Confidence Interval|Mean
2750330|NCT00874250|Secondary|Days of Convalescence Stay in an Intensive Care Unit|Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation|During the Index Hospitalization||||participants|||Number
2750288|NCT00874614|Secondary|Changes From Baseline in Overall Quality of Life (QoL) - Best Response Within 12 Months After First Therapeutic Dose of AZEDRA®.|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 v.3 was used to evaluate QoL. This questionnaire was comprised of 30 questions, two of which pertain to a patient's Global Health Status and QoL. The two questions used a 7-point Likert scale of 1 (very poor) to 7 (excellent), in which the scores were averaged and linearly transformed to a 0-100 scale with higher scores indicating better health status and QoL. The questionnaire was administered at baseline and through 12 months after the first therapeutic dose of AZEDRA®. The results of QoL and changes from baseline were summarized by visit and the best response within 12 months after first therapeutic dose of AZEDRA® was reported. The outcome represents the mean change from baseline in overall QoL based on the best response reported within 12 months after first therapeutic dose of AZEDRA®.|12 Months|53 patients with data available.|||score on a scale||Standard Deviation|Mean
2750289|NCT00874614|Secondary|Best Confirmed Overall Tumor Response of Complete Response (CR) or Partial Response (PR) by RECIST 1.0.|Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 was assessed by two independent central reviewers and one adjudicator, and overall response (PR or CR) was confirmed by follow-up imaging at the subsequent timepoint. Complete response was defined as confirmed disappearance of all target lesions and Partial Response was defined as confirmed decreased of >= 30% in baseline sum of the longest diameter of target lesions.|12 months|There were 64 patients with tumor measurements evaluable for tumor response.|||percentage of patients||95% Confidence Interval|Number
2750290|NCT00874614|Primary|Percentage of Patients Who Experienced a 50% or Greater Reduction (Including Discontinuation) of All Antihypertensive Medication(s) Lasting for at Least Six Months.||12 months||||percentage of patients||95% Confidence Interval|Number
2750291|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days post-vaccination|Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
2750292|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
2750293|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.|||Titers||95% Confidence Interval|Geometric Mean
2750294|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
2750295|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
2750296|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days Post-vaccination 2|Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.|||Titers||95% Confidence Interval|Geometric Mean
2750297|NCT00874549|Primary|Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2|Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|Day 0 to 7 Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.|||Participants|||Number
2750298|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2|Solicited injection site reactions: Pain, Erythema, and Swelling.|0-7 Days Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.|||Participants|||Number
2750299|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.|||Titers||95% Confidence Interval|Geometric Mean
2750300|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2||28 Days post-vaccination 2|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
2750301|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
2750331|NCT00874250|Secondary|Operative Blood Loss (mL)|Blood loss in mL during initial device implantation procedure|Initial Device Implant Procedure During Index Hospitalization||||mL||Standard Deviation|Median
2750302|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.|||Titers||95% Confidence Interval|Geometric Mean
2750303|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2||Day 28 Post-vaccination 2|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
2750304|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
2750305|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.|Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|0-7 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.|||Participants|||Number
2750306|NCT00874510|Primary|Hours Slept on Overnight Extended Duty Call Shifts|Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.|12 months||||hours|Participants|95% Confidence Interval|Mean
2750307|NCT00874497|Secondary|Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)|Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan.|||percentage of participants|||Number
2750308|NCT00874497|Secondary|Percentage of Participants With COPD Exacerbations by Group at Week 104|For the COPD exacerbations, baseline is defined as Randomization (Day 1). COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit).|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan.|||percentage of participants|||Number
2750309|NCT00874497|Secondary|Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications|Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 14 and 9 respectively.|||number of puffs||Standard Deviation|Mean
2750310|NCT00874497|Secondary|Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum|Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum. The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough).|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 13 and 9 respectively.|||units on a scale||Standard Deviation|Mean
2750311|NCT00874497|Secondary|Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)|Change from baseline in sRaw and sGaw is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.|||kPa.sec||Standard Deviation|Mean
2750312|NCT00874497|Secondary|Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline in DLco is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.|||mmoL/min/kPA||Standard Deviation|Mean
2750313|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)|Change from baseline in trough FRCpleth is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.|||mL||Standard Deviation|Mean
2750314|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough Inspiratory Capacity|Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table.|Baseline toWeek 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 25 and 14 respectively.|||mL||Standard Deviation|Mean
2750315|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough RV/TLC|Change from Baseline in Trough RV/TLC is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were n= 21 and 14 respectively.|||unitless||Standard Deviation|Mean
2750332|NCT00874250|Secondary|Procedure Time (Minutes)|Total time in minutes required for surgical device implantation.|Initial Device Implant Procedure During Index Hospitalization||||Minutes||95% Confidence Interval|Median
2750333|NCT00874250|Secondary|The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.||Treatment through 1 month post procedure||||participants|||Number
2750316|NCT00874497|Secondary|Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])|Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 22 and 16 respectively.|||mL||Standard Deviation|Mean
2750317|NCT00874497|Secondary|Change From Baseline to Week 104 in Cumulative Frequency of HU|The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator). Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.|||Hounsfield unit*hour||Standard Deviation|Mean
2750318|NCT00874497|Secondary|Observed Rate of Change in Emphysema From Baseline to Week 104|The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000. The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit - date of baseline visit + 1]/365.25).|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.|||g/L||Standard Deviation|Mean
2750319|NCT00874497|Secondary|Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104|The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable. For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 46 and 26 respectively.|||Hounsfield unit/year||Standard Deviation|Mean
2750320|NCT00874497|Secondary|Density Mask Score Based on Specified Thresholds Including -950 HU|The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest. The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration. Changes in the density mask score was assessed using only a single density mask threshold of -950 HU.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.|||Hounsfield unit||Standard Deviation|Mean
2750321|NCT00874497|Secondary|Percent Change From Baseline in Trough FEV1 From Baseline to Week 104|The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X - value at baseline] /value at baseline) x 100.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 28 and 18 respectively.|||percentage change||Standard Deviation|Mean
2750322|NCT00874497|Primary|Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels|The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 43 and 25 respectively.|||Hounsfield unit/year||Standard Deviation|Mean
2750323|NCT00874497|Primary|Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)|The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below.|Baseline to Week 104|The Intent-to-Treat (ITT) population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable High-resolution computed tomography (HRCT) scan.|||L||Standard Deviation|Mean
2750324|NCT00874276|Secondary|Terminal Half-life (the Amount of Time Needed to Clear One-half of the Dose of Drug)for Environmental Dose 2.5 ug/kg/Day.|Terminal half-life (the amount of time needed to clear one-half of the dose of drug)for the environmental dose 2.5 ug/kg/day.|24 hours for analysis on Day 5, Environmental dose|same as Primary|||minutes||Inter-Quartile Range|Median
2750325|NCT00874276|Primary|Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized.|Terminal half-life (the amount of time needed to clear one-half of dose of the drug).|24 hours for analysis on Day 5, Clinical dose|All completing subjects (2 withdrawals have no pharmacokinetic data on this parameter) The intent was to accrue 12 per group but the grant ended before that could be achieved. Subjects were recruited from a large pool but the two genetically defined subgroups are rare.|||Minutes||Inter-Quartile Range|Median
2750326|NCT00874250|Secondary|Intensive Care Unit (ICU) Stay|Subjects admitted to ICU during index hospitalization|Initial Device Implant Index Hospitalization||||Participants|||Count of Participants
2750327|NCT00874250|Secondary|Procedural Survival|Subjects who survived the index procedure|Initial Device Implant Procedure During Index Hospitalization||||Participants|||Count of Participants
2750328|NCT00874250|Secondary|Time in Days to Return to Normal Daily Activities|This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.|Average time within one month window||||Days||Full Range|Median
2750329|NCT00874250|Secondary|Total Length of Hospital Stay (Days)|Total days of hospital stay during the initial hospitalization for implantation of device|Total Duration of the Index Hospitalization||||Days||Full Range|Median
2750335|NCT00874237|Other Pre-specified|Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)|A thorough QT/QTc study may be considered to have demonstrated assay sensitivity if 1 or more of the lower 95% CI values exceeds 5 msec ant any of the 9 predetermined time points|1, 1.5, 2, 2.5, 3, 5, 8, 12, and 24 hr|"All subjects who completed both Inhaled placebo + oral placebo and moxifloxacin 400 mg + Inhaled placebo.~LSM and CI statistics were based on the individual (within subject) corrected differences between moxifloxacin and placebo exposures per ICH Guideline E14 for a thorough QT study."|||mseconds||95% Confidence Interval|Least Squares Mean
2750336|NCT00874237|Secondary|Numbers and % of Subjects With QTcI Change > 60 ms|Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours|QT Population (all subjects receiving placebo and inhaled loxapine and providing QT data|||Participants|||Count of Participants
2750337|NCT00874237|Secondary|Numbers and % of Subjects With QTcI Change > 30 ms|Numbers and Percents of Subjects with QTcI increase from baseline exceeding 30 ms|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours|QT Population (all subjects receiving placebo and inhaled loxapine and providing QT data|||Participants|||Count of Participants
2750338|NCT00874237|Secondary|Numbers and % of Subjects With QTcI > 480 ms|Numbers and Percents of Subjects with QTcI exceeding 480 ms|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours|QT Population (all subjects receiving placebo and inhaled loxapine and providing QT data|||Participants|||Count of Participants
2750339|NCT00874237|Secondary|Numbers and % of Subjects With QTcI > 450 ms|Numbers and Percents of Subjects with QTcI exceeding 450 ms|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours|QT Population (all subjects receiving placebo and inhaled loxapine and providing QT data|||Participants|||Count of Participants
2750340|NCT00874237|Secondary|Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.|QTcI change at the median loxapine concentration (32.2 mcg/mL) based on nonlinear regression of QTcI versus log of time matched serum loxapine concentrations. This analysis looks for repolarization versus concentration relationship in a positive or negative thorough QT/QTc study result.|24 hours|"QT + PK Population (all subjects receiving placebo and loxapine who provided QTc and pharmacokinetic data).~LSM and CI statistics were based on the individual (within subject) corrected differences between loxapine and placebo exposures per ICH Guideline E14 for a thorough QT study."|||mseconds||95% Confidence Interval|Least Squares Mean
2750341|NCT00874237|Primary|Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo|Largest of the upper CIs of the time matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time matched placebo subtraction for ADASUVE treatment at 12 prespecified post inhalation times|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours|QT population (all patients receiving both placebo and 10 mg inhaled loxapine. LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.|||mseconds||95% Confidence Interval|Least Squares Mean
2750342|NCT00874120|Primary|Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).|Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.|24 hours after final dose of each 7-day treatment period.|The per-protocol population included 100 participants who completed both treatment periods and have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) data for SBP measurements for each study drug, 46 participants who received phenylephrine followed by placebo and 54 participants who received placebo followed by phenylephrine.|||mmHg||Standard Deviation|Mean
2750343|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks|Pre-treatment to 6 weeks after treatment||||units on a scale||Standard Deviation|Mean
2750344|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks|Pre-treatment to 2 weeks after treatment||||units on a scale||Standard Deviation|Mean
2750345|NCT00874094|Secondary|Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week|pre-treatment to 1 week after treatment|The number of participants required to demonstrate a 1 point difference between pre and post treatment values|||units on a scale||Standard Deviation|Mean
2750346|NCT00874094|Primary|Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.|Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.|Difference in Measurements taken Pre-treatment and 12 weeks after treatment.|Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.|||units on a scale||Standard Deviation|Mean
2750347|NCT00874029|Secondary|Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)|The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.|12 months||||percentage of patients|||Number
2750348|NCT00874029|Secondary|Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)|The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.|12 months||||Units on a scale||Standard Deviation|Mean
2750437|NCT00873041|Secondary|Extension Study: Change From Baseline in Hemoglobin at Month 24|Blood was collected for Hemoglobin at Baseline and Month 24. Change from Baseline= Month 24 hemoglobin - Baseline hemoglobin.|Core Baseline, Month 24|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.|||g/L||95% Confidence Interval|Mean
2750349|NCT00874029|Secondary|Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.|"The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life.~Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates change in symptoms, a negative number indicates a reduction in symptoms and therefore improvement.~Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates change in health and quality of life, a positive number indicates and improvement."|12 months from Baseline||||Units on a scale||Standard Deviation|Mean
2750350|NCT00874029|Secondary|Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)|Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.|12 month from Baseline|The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.|||percentage of volume||95% Confidence Interval|Mean
2750351|NCT00874029|Primary|Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment|Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.|12 months from Baseline||||participants|||Number
2750352|NCT00874029|Primary|Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure|An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).|12 months||||participants|||Number
2750353|NCT00874029|Primary|Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure|Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.|12 months from Baseline||||Percentage of participants|||Number
2750354|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-181 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
2750355|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-29 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
2750356|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One AE||Days 1-15 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
2750357|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)|Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
2750450|NCT00873041|Secondary|Core Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for the following cases:~Baseline serum ferritin versus baseline LIC~Serum ferritin difference from baseline at fourth quarter versus difference from baseline in LIC at Week 52.~A value of 1.0 indicates a perfect correlation."|Baseline, 52 weeks|Participants from the Full Analysis Set (all randomized participants).|||Correlation coefficient|||Number
2750358|NCT00873912|Primary|Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
2750359|NCT00873873|Secondary|Protease/Antiprotease|"MMP9/TIMP 1 molar ratio MMP9 is matrix metalloproteinse 9 and is a protease enzyme that is responsible for tissue degradation of extracellular matrix and could be a factor in airway remodeling.~TIMP 1 is an abbreviation for tissue inhibitor of metalloproteinase-1 and is an inhibitor of MMP9 and would serve to balance the activity protease activity of MMP9 and this it is an anti-protease.~Therefore the ratio of MMP9 and TIMP1 is used to assess the relative balance of protease and antiprotease activity."|Measured at Year 2|54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia).|||ratio||Standard Deviation|Mean
2750360|NCT00873873|Primary|Airway Wall Thickness|Segmental average airway wall thickness|Measured at Year 2|There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly.|||mm||Standard Deviation|Mean
2750361|NCT00873860|Secondary|Time to First Moderate or Severe Asthma Exacerbation|Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.|Day 1 to Day 92 and Day 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.|||days||Standard Error|Mean
2750362|NCT00873860|Secondary|Moderate or Severe Asthma Exacerbations Per Person Per Annum|Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days*365 days, where X = 92 or 169).|Day 1 to Day 92 and Day 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.|||asthma exacerbations/person/annum||Standard Error|Mean
2750363|NCT00873860|Secondary|Percentage of Participants With at Least 1 Moderate or Severe Exacerbation|Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation.|||Percentage of Participants|||Number
2750364|NCT00873860|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to 169|Safety population included all participants who received any dose of the investigational product.|||participants|||Number
2750365|NCT00873860|Secondary|Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit||Day 1, 92 and 169|Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2750366|NCT00873860|Secondary|Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit||Day 1, 92 and 169|Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2750367|NCT00873860|Secondary|Serum Concentration for CAT-354||Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169|Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2750387|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
2751200|NCT00866905|Primary|Pathologic Complete Response Rate (pCR)|Pathologic complete response (pCR) rate will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following neoadjuvant treatment with six (21-day) cycles of ixabepilone and cyclophosphamide|6 months||||participants|||Number
2750368|NCT00873860|Secondary|Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5|Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (<=) 0.75 or mean ACQ score greater than (>) 0.75 and less than (<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (>) 0.75 but less than (<) 1.5 indicated partly controlled asthma.|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.|||percentage of participants|||Number
2750369|NCT00873860|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better).|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
2750370|NCT00873860|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline|Day 1, 29, 57, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
2750371|NCT00873860|Secondary|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 1, 29, 57, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
2750372|NCT00873860|Secondary|Number of Puffs of Rescue Beta-2 Agonist Per Week|Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.|Day -7 to 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||puffs per week||Standard Deviation|Mean
2750373|NCT00873860|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169|The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169.|Day -7 to 1 (predose), Day 2 to 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters/minute||Standard Deviation|Mean
2750374|NCT00873860|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169|Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.|Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters||Standard Deviation|Mean
2755722|NCT00836875|Secondary|All-Cause Mortality - Number of Participant Deaths|Number of participant deaths reported at Week 6 and at EOT (up to Week 12).|Week 6 and EOT (up to Week 12)|Safety population|||participants|||Number
2750375|NCT00873860|Secondary|Time to First Observed Asthma Control|Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).|Day 1 to Day 92 and Day 169|Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, >50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169.|||days||95% Confidence Interval|Median
2750376|NCT00873860|Primary|Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.|Day 1 and 92|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2750377|NCT00873821|Primary|Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration|Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24|Baseline (predose Day 1) to Day 13||||mg/dL||Standard Deviation|Least Squares Mean
2750378|NCT00873821|Primary|Number of Participants With Any Laboratory Adverse Experience|Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.|2 months|All study participants|||participants|||Number
2750379|NCT00873821|Primary|Number of Participants With Any Clinical Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.|2 months|All study participants|||participants|||Number
2750380|NCT00873782|Primary|Muscle, Nerve, or Vascular Damage|"Number of Participants with all of the following three:~Unchanged Doppler ultrasound to assess venous and arterial damage pre-and post perfusion based on report~Without clinically significant changes in electrodiagnostic testing using standard neurographic techniques pre-and post perfusion:>1 mSec change in baseline distal motor latency; <75% baseline compound muscle action potential amplitude, <75% baseline conduction velocity, sensory nerve action potential~Without clinically significant changes in Quantitative muscle testing (QMT) strength assessments pre-and post perfusion:< 85% baseline"|Measured within 2 weeks after limb perfusion procedure||||participants|||Number
2750381|NCT00873730|Secondary|Change in C-reactive Protein (CRP) From Baseline to Week 12.|CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.|Baseline and 12 weeks|The analysis population is the intent to treat.|||mg/l||Standard Deviation|Mean
2750382|NCT00873730|Secondary|Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms||12 weeks|The population for this assessment was patients who had ocular inflammatory disease at baseline. The number of patients analyzed is zero because no patients had symptoms of ocular inflammatory disease at baseline.|||patients|||Number
2750383|NCT00873730|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and 12 weeks|The analysis population was the intent to treat population. Two scored areas had a different “Number of Participants Analyzed” in the etanercept arm. Bodily pain had 45 and Emotional role limitations had 46.|||units on scale||Standard Deviation|Mean
2750384|NCT00873730|Secondary|Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire|EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750385|NCT00873730|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||mm/hour||Standard Deviation|Mean
2750386|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
2750436|NCT00873041|Secondary|Extension Study: Change From Baseline in Transferrin Saturation at Month 24|Blood was collected for transferrin saturation at Baseline and Month 24. Change from baseline= Month 24 transferrin saturation - baseline transferrin saturation.|Core Baseline, Month 24|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.|||Percent saturation||95% Confidence Interval|Mean
2750388|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
2750389|NCT00873730|Secondary|Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.|Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 - 10 (0 = none and 10 = severe).|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
2750390|NCT00873730|Secondary|Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.|Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 - 10 (0 = no pain and 10 = most severe pain).|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
2750391|NCT00873730|Secondary|Number of Patients Achieving Partial Remission.|Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750392|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750393|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750394|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750395|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750396|NCT00873730|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
2750397|NCT00873457|Secondary|Event-free Survival|Event-free survival will be defined as the length of time between the discontinuation of study treatment and disease progression, next therapy, or death,whichever comes first, up to a maximum of 2 years.|up to a maximum of 2 years|All treated patients|||Days||Full Range|Median
2750398|NCT00873457|Secondary|Overall Survival|Overall survival is defined as the length of time between discontinuation of perifosine until death or 2 year's followup, whichever comes first.|up to a maximum of 2 years|All treated patients|||Days||Full Range|Median
2750399|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 6 months of treatment|Patients who completed 6 months of therapy|||participants|||Number
2750400|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 3 months of treatment|Patients who completed 3 months of therapy.|||participants|||Number
2750535|NCT00871845|Primary|Percentage of Participants With HCV RNA (Early Virological Response)|Early virological response (EVR) defined as a greater than 2-log10 decline in serum HCV RNA from the pretreatment baseline or an undetectable serum HCV RNA at treatment week 12|Week 12||||percentage of participants|||Number
2750401|NCT00873366|Secondary|Median of 6 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750402|NCT00873366|Secondary|Median of 3 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750403|NCT00873366|Secondary|Median of 6 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750404|NCT00873366|Secondary|Median of 3 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750405|NCT00873366|Secondary|Median of 6 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750406|NCT00873366|Secondary|Median of 3 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750407|NCT00873366|Secondary|Median of 6 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750408|NCT00873366|Secondary|Median of 3 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
2750409|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between 6 Month DM-BT and 6 Month Endoxifen Steady State Concentrations|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)|6 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
2750410|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between 3 Month DM-BT and 3 Month Endoxifen Steady State Concentrations|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)|3 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
2750411|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio|Baseline, 3 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
2750412|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen Steady State Concentrations|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)|Baseline, 3 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
2750413|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio|Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx/NDMT ratio|3 Month and 6 Month|All eligible participants with Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
2750414|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen Steady State Concentrations (Endx Css)|Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx Css|3 Month and 6 Month|All eligible participants with Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
2750415|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between CYP2D6 Genotype and ¹³Cdextromethorphan Breath Test (DM-BT)|Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and DM-BT values.|Baseline, 3 month and 6 month|All eligible participants with DM-BT values.|||Correlation coefficient|||Number
2750416|NCT00873366|Primary|Operating Characteristics of the ¹³C-dextromethorphan (13C-DM) Breath Test in Identifying Those Who Are CYP2D6 Genotypic Poor Metabolizers|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The distribution of CYP2D6 genotypes grouped by CYP2D6 metabolism phenotype for each participants are summarized below."|Baseline||||Participants|||Count of Participants
2750417|NCT00873327|Primary|Piperacillin Pharmacokinetics (PK)|To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study|2-3 days after infant receives 1st drug dosing|All 32 subjects that were enrolled during the study.|||L/hr/kg||95% Confidence Interval|Median
2750418|NCT00873119|Secondary|Time to Progression (TTP)|Time from the date of randomization to the time of disease progression|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.|||months||95% Confidence Interval|Median
2750419|NCT00873119|Secondary|Duration of Response|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD ([Progressive Disease]) or death was documented|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication|||months||95% Confidence Interval|Median
2750420|NCT00873119|Secondary|Time to Response|For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Patients with overall best response being either complete response or partial response.|||months||Full Range|Median
2750421|NCT00873119|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.|||months||95% Confidence Interval|Median
2750422|NCT00873119|Secondary|Best Overall Response|The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.|||percentage of participants|||Number
2750423|NCT00873119|Primary|Progression Free Survival|Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy|||months||95% Confidence Interval|Median
2750424|NCT00873093|Other Pre-specified|Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.|This outcome measure cannot be reported due to the data used for analysis was not collected.|Day 8 of blocks 1 and 2|||||||
2750425|NCT00873093|Other Pre-specified|Plasma Concentration-time Profiles|Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).|Up to day 8 of block 2|These were for correlative biology studies and the data were not collected in COG database.||||||
2750426|NCT00873093|Other Pre-specified|Change in Stem Cell Percentage|Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.|Baseline to post-treatment with bortezomib|These were for correlative biology studies and the data were not collected in COG database.||||||
2750427|NCT00873093|Other Pre-specified|Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots|Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.||||||
2750428|NCT00873093|Other Pre-specified|NF-kB Activity|NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.||||||
2750429|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3.|End of Block 3 (Day 36 of Block 3) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3.|||Percentage of participants|||Number
2750430|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2.|End of Block 2 (Day 36 of Block 2) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.|||percentage of participants|||Number
2750431|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1.|End of Block 1 (Day 36 of Block 1) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.|||percentage of participants|||Number
2750432|NCT00873093|Primary|Severe Adverse Events (SAE) Rate.|The proportion of SAE rate among all eligible patients|4 months|The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.|||percentage of participants|||Number
2750433|NCT00873093|Primary|Toxic Death Rate|The proportion of toxic death rate among all eligible patients.|4 months|The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.|||percentage of participants|||Number
2750434|NCT00873093|Primary|Event Free Survival|Percentage of patients who were event free at 4 months|4 months after enrollment|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.|||Percentage of participants|||Number
2750435|NCT00873093|Primary|Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy|The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.|The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.|||Percentage of participants|||Number
2750438|NCT00873041|Secondary|Extension Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for serum ferritin difference from Baseline at Month 24 versus LIC difference from Baseline at Month 24.~A value of 1.0 indicates a perfect correlation."|Core Baseline, Month 24|Participants from the Extension Full Analysis Set (all randomized participants)in the Extension Study with data available for analysis.|||Correlation coefficient|||Number
2750439|NCT00873041|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|LIC was measured by magnetic resonance imaging technique at Baseline and Month 24. A negative change from baseline indicated improvement.|Core Baseline, Month 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
2750440|NCT00873041|Primary|Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study|Liver iron concentration was measured at Core Baseline and at the end of the Extension Study. Magnetic Resonance Imaging (MRI) scans were analyzed at a central laboratory to determine the LIC value. The percentage of participants with LIC < 5 mgFe/g dw (milligram iron/gram dry weight) change from Baseline at the end of the Extension Study is reported.|Core Baseline to End of Extension Study (up to 24 months)|Full Analysis consisted of all randomized participants. Patients with post-baseline LIC satisfying criterion at any time during the study are counted as responder. Patients with no baseline LIC or without any post-baseline LIC measurements will be assumed as non-responder.|||Percentage of participants||95% Confidence Interval|Number
2750441|NCT00873041|Secondary|Extension Study: Absolute Change in Serum Ferritin From Baseline to Eighth Quarter|Blood was collected for serum ferritin at Core Baseline and monthly during the Eighth quarter of the Extension Study. Absolute change from Baseline: quarterly average - baseline average. A negative change from baseline indicated improvement.|Core Baseline, Eighth Quarter (last 3 months of the study)|Full Analysis Set included all randomized participants. Only patients with a value both at baseline and at considered time point are included.|||micrograms/liter||Standard Deviation|Mean
2750442|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Pulse Rate|"Pulse Rate was measured at each visit.~A Notably Abnormal Pulse Rate was defined as a measurement in one of the following two categories:~High: ≥120 with an increase from baseline ≥15 beats per minute (bpm)~Low: ≤50 with a decrease from baseline ≥15 bpm"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.|||Percentage of participants|||Number
2750443|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Diastolic Blood Pressure|"Diastolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.~A Notably Abnormal Diastolic Blood Pressure was defined as a measurement in one of the following two categories:~High: ≥105 with an increase from baseline ≥15 mmHg~Low: ≤50 with a decrease from baseline ≥15 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.|||Percentage of participants|||Number
2750444|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Systolic Blood Pressure|"Systolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.~A Notably Abnormal Systolic Blood Pressure was defined as a measurement in one of the following two categories:~High: ≥180 with an increase from baseline ≥20 mmHg~Low: ≤90 with a decrease from baseline ≥20 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.|||Percentage of participants|||Number
2750445|NCT00873041|Primary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 52 with treatment as factor and baseline LIC as covariate.|Baseline, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
2750446|NCT00873041|Secondary|Core Study: Percentage of Participants With Notable Abnormal Post-baseline Laboratory Results|"The percentage of participants with notable laboratory results:~Platelet count: (<100 x 10^9/L)~Absolute neutrophils: (<1.5 x 10^9/L)~Alanine aminotransferase (ALT): (>5 x Upper limit normal (ULN) and >2 x baseline).~Aspartate aminotransferase (AST): (>5 x ULN and >2 x baseline)~Serum creatinine: (>33% increase from baseline and >ULN at ≥2 consecutive post-baseline values) Creatinine clearance: (<60 mL/min at ≥2 consecutive post-baseline values)~Urinary protein/creatinine ratio: (≥ 1.0 mg/mg at ≥2 consecutive post-baseline values)"|52 Weeks|Safety Set included all randomized participants who received treatment.|||Percentage of participants|||Number
2750447|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) in Placebo Patients From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. The change in liver iron concentration for participants in the placebo arm was used to assess the iron accumulation rate.|Baseline, Week 52|Safety Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
2750448|NCT00873041|Secondary|Core Study: Change From Baseline in Transferrin Saturation at Month 12|Blood was collected for transferrin saturation at Baseline and Month 12. Change from baseline= Month 12 transferrin saturation - baseline transferrin saturation.|Baseline, Month 12|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.|||Percent saturation||Standard Deviation|Mean
2750449|NCT00873041|Secondary|Core Study: Change From Baseline in Hemoglobin at Month 12|Blood was collected for Hemoglobin at baseline and Month 12. Change from baseline= Month 12 hemoglobin - baseline hemoglobin.|Baseline, Month 12|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.|||g/L||Standard Deviation|Mean
2755737|NCT00836719|Secondary|Change in Brain NAA Level as Measured by MR Spectroscopy|percent change from baseline to exit in NAA levels adjusted for creatine levels|6 months||||percentage change from baseline||95% Confidence Interval|Mean
2750451|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline At Week 24 and Week 52 in Patients With Dose Increases After Week 24|LIC was measured by magnetic resonance imaging technique at baseline, Week 24 and Week 52. Dose Doubling (Dose Increases) began at Week 24.|Baseline, Week 24, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24 and Week 52. Only patients with dose increases after week 24, with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
2750452|NCT00873041|Secondary|Core Study: Percentage of Participants With Adverse Events Graded Mild, Moderate and Severe|Percentage of Participants with Mild, Moderate and Severe adverse events (AE) any primary system organ class regardless of study drug relationship. A patient with multiple occurrences of an AE is counted only once in the AE category for that treatment. A patient with multiple severity ratings for an AE while on a treatment is only counted once under the maximum rating.|52 Weeks|Safety Analysis Set included all randomized participants who received treatment.|||Percentage of participants|||Number
2750453|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Second Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.~Second quarter serum ferritin average was the average of all serum ferritin values obtained within days 106-195.~Change from baseline: second quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 106 to Day 195)|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the second quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.|||μg/L||Standard Deviation|Mean
2750454|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Fourth Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.~Fourth quarter serum ferritin average was the average of all serum ferritin values obtained within days 286- End of Study.~Change from baseline: fourth quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 286 to End of Study [Day 365])|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the fourth quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.|||μg/L||Standard Deviation|Mean
2750455|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 24|LIC was measured by magnetic resonance imaging technique at baseline and Week 24. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 24 with treatment as factor and baseline LIC as covariate.|Baseline, Week 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
2750456|NCT00873015|Secondary|Efficacy of 14 Day Infusion of Sodium Nitrite||14 days|||||||
2750457|NCT00873015|Secondary|Safety of a 14 Day Infusion of Sodium Nitrite||14 days|||||||
2750458|NCT00873015|Primary|Mean Plasma Nitrite Concentration (Micromol/L)|Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.|multiple time points up to the end of day 14|Per protocol|||micromol/L||Standard Deviation|Mean
2750459|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.|||participants|||Number
2750460|NCT00872989|Secondary|Time to Treatment Failure|Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.||||Months||95% Confidence Interval|Median
2750461|NCT00872989|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2750462|NCT00872989|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|every 3 months for two years and then every 6 months for 3 years||||months||95% Confidence Interval|Median
2750463|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.|||participants|||Number
2750464|NCT00872989|Primary|Progression Free Survival (PFS)|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years||||months||95% Confidence Interval|Median
2750465|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale|"The Children's Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750466|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale|"The Children's Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750467|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale|"The Children's Communication Checklist-2 (CCC-2) Nonverbal Communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750468|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale|"The Children's Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750469|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale|"The Children's Communication Checklist-2 (CCC-2) Scripted Language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750470|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale|"The Children's Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750471|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale|"The Children's Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2755738|NCT00836719|Primary|Number of Participants Experiencing Serious Adverse Events||six months||||participants|||Number
2750472|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale|"The Children's Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750473|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale|"The Children's Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750474|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale|"The Children's Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750475|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Communication|"The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750476|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Social Interaction|"The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750477|NCT00872898|Primary|Change in Total Raw Score of Social Responsiveness Scale|"The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment).~Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750478|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Total Score|"The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
2750479|NCT00872898|Primary|Extent of Absorption of Memantine (Part One)|Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.|Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose|Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)|||ng•h/mL||Standard Deviation|Mean
2750480|NCT00872833|Secondary|Report of Pain by Length of the Transfusion Cycle|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles|Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.|||percentage of participant-cycles|Participants||Number
2750481|NCT00872833|Primary|Report of Pain by Age Group|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles||||percentage of participant-cycles|Participants||Number
2750482|NCT00872729|Primary|Pharmacodynamic Parameter: Changes of White Blood Cell (WBC) Cystine Level From Baseline|"The pharmacodynamic (PD) parameter measures the changes of WBC cystine level from the baseline.~Cystine is a disulfide amino acid formed through oxidation of two molecules of cysteine; hence, cystine's concentration is commonly given in half-cystine equivalents to avoid confusion.~The level of cystine in WBC/leukocytes is expressed in units of nmol half-cystine/mg protein (nmol ½ cystine/mg protein). Half-cystine is quantified by a reduction of cystine followed by an assay for cysteine, which is then normalized by the total cellular protein content within the sample using methods of such as Lowry assay, bicinchoninic acid assay, or Bradford."|up to 12 hours post Cystagon® dosing and RP103 dosing|Sample size is based on feasibility rather than statistical considerations. Analysis time differences (0-6 hours) is due to different absorption characteristics of Cysteamine between RP103 and Cystagon. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.|||nmol 1/2 cystine/mg protein||Standard Deviation|Mean
2750483|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: AUC(0-t) of Cysteamine|t = 6 for Cystagon and t = 12 for RP103. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.|12 hours post RP103 dosing and 6 hours post 1st Cystagon® dosing|Subjects were enrolled sequentially according to the study design. A mixed-effects linear model was used to assess differences between the RP103 and Cystagon treatment groups. Sample size is based on feasibility rather than statistical considerations.|||umol•h/L||Geometric Coefficient of Variation|Geometric Mean
2750484|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Tmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing||||hour||Full Range|Median
2750485|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Cmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing||||umol/L||Geometric Coefficient of Variation|Geometric Mean
2750486|NCT00872599|Secondary|HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension|HDL-cholesterol concentration measured on the last day of fenofibrate treatment in salt-resistant and salt-sensitive hypertensive patients|Measured on day 6 of high salt intake and fenofibrate treatment|All subjects who completed the protocol|||mg/dL||Standard Deviation|Mean
2750487|NCT00872599|Primary|Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment|"Difference in blood pressure (mean arterial pressure) measured on the last day of high salt intake and fenofibrate treatment minus blood pressure (mean arterial pressure) measured during high salt intake and placebo treatment in participants classified as being salt-sensitive versus salt-resistant.~Participants were classified as salt-sensitive if the average study day mean arterial pressure (MAP) was at least 5 mmHg higher during the high salt placebo arm than during low salt intake."|pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo|All subjects who completed entire protocol|||mm Hg||Standard Deviation|Mean
2750488|NCT00872534|Primary|Incidence of Subjects With Gastroduodenal Erosions and Ulcers.|Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).|After 7 days of study medication||||participants|||Number
2750489|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (FGFR3)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
2750490|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Bcl-2)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
2750491|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
2750492|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (p53).|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
2750493|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
2750536|NCT00871819|Primary|Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)||Immediately post-procedure||||Correlation coefficient|||Number
2750494|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
2750495|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
2750496|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (p53)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
2750497|NCT00872521|Secondary|Assessment of Quality of Life (AQoL) Scores|The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).|Up to 2 years|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Scores on a scale||Standard Deviation|Mean
2750498|NCT00872521|Secondary|Overall Survival|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Percentage of participants|||Number
2750499|NCT00872521|Secondary|Event Free Survival (EFS)|Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Percentage of participants|||Number
2750500|NCT00872521|Secondary|Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.|3-months after ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Participants|||Number
2750501|NCT00872521|Secondary|Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).|Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.|3-months following ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Participants|||Number
2750502|NCT00872521|Secondary|Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Particiipants|||Number
2750503|NCT00872521|Primary|Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour|84 days|Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.|||Participants|||Number
2750504|NCT00872430|Primary|Intestinal Transit Time|Radiologic technique consisting of the ingestion of radiopaque markers, followed by a simple x-ray of the abdomen on day 3 of each intervention period. Standard formula, regarding markers ingested, time of ingestion and markers still present on the colon (counted by radiologist unaware of the treatment allocation), provided transit time.|day 3 and day 17||||hours||Standard Deviation|Mean
2750505|NCT00872430|Secondary|Number of Patients With no Evacuation After Each Intervention Period|The number of patients who had not evacuated on day 5 of each intervention period was obtained using questions 1 and 9 of the Scale for Assessment of Constipation Symptoms based on: 1) How many times have you had a bowel movement in the last 24 hours?; 9) Classification of bowel habit on a scale of 1 (terrible) to 5 (excellent).|day 5 and day 19||||participants|||Number
2750506|NCT00872339|Secondary|Impact of Pain on Functioning and Well-being||Measured at Month 9||||participants|||Number
2750507|NCT00872339|Secondary|Pain Occurrence by Age||Measured at Month 9||||participants|||Number
2750508|NCT00872339|Secondary|Common Sites of Pain||Measured at Month 9||||participants|||Number
2750509|NCT00872339|Primary|Prevalence of Pain||Measured at Month 9||||participants|||Number
2750510|NCT00872170|Secondary|Change in Arginase Activity From Baseline to Week 12 Among Sildenafil Group|Change in Arginase activity was calculated as Arginase activity at week 12 minus Arginase activity at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||U/L||Standard Error|Mean
2750511|NCT00872170|Secondary|Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group|Change in Arginase concentration was calculated as Arginase concentration at week 12 minus Arginase concentration at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ng/ml||Standard Error|Mean
2750512|NCT00872170|Secondary|Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group|Change in Cell Free Hemoglobin was calculated as Cell Free Hemoglobin at week 12 minus Cell Free Hemoglobin at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ug/ml||Standard Error|Mean
2750513|NCT00872170|Secondary|Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group|Change in Lactate dehydrogenase (LDH) was calculated as LDH at week 12 minus LDH at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no LDH at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.|||U/L||Standard Error|Mean
2750514|NCT00872170|Secondary|Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group|Change in Soluble platelet selectin (sP-SELECTIN) was calculated as sP-SELECTIN at week 12 minus sP-SELECTIN at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ng/ml||Standard Error|Mean
2750515|NCT00872170|Secondary|Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Red Blood Cell (RBC) Arginine was calculated as Red Blood Cell (RBC) Arginine at week 12 minus Red Blood Cell (RBC) Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||µM||Standard Error|Mean
2750516|NCT00872170|Secondary|Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Plasma Arginine was calculated as Plasma Arginine at week 12 minus Plasma Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||µM||Standard Error|Mean
2750517|NCT00872170|Secondary|Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end diastolic volume (LVEDV) was calculated as LVEDV at week 12 minus LVEDV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ml||Standard Error|Mean
2750518|NCT00872170|Secondary|Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end systolic volume (LVESV) was calculated as LVESV at week 12 minus LVESV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ml||Standard Error|Mean
2750519|NCT00872170|Secondary|Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group|Change in tricuspid regurgitant jet velocity (TRV) was calculated as TRV at week 12 minus TRV at baseline. The TRV provides an estimate of pulmonary artery pressure.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||m/s||Standard Error|Mean
2750520|NCT00872170|Primary|Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group|Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no 6MWT at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.|||meters||Standard Error|Mean
2750521|NCT00872079|Primary|Patient Genomics|During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.|Baseline||||participants|||Number
2750522|NCT00872027|Primary|Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation||Measured within 2 days of participant recruitment||||participants|||Number
2750532|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)|Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.|||ng/minute||Standard Deviation|Least Squares Mean
2750533|NCT00871845|Primary|Percentage of Participants With Early Virological Response (EVR) and Significant Weight Loss|EVR compared between overweight subjects who achieved significant weight loss (>=3%) and those who did not|Week 12||||percentage of participants|||Number
2750523|NCT00872001|Secondary|Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)|Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.|||Percentage of Participants|||Number
2750524|NCT00872001|Primary|Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)|Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.|||Percentage of Participants|||Number
2750525|NCT00871975|Primary|Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics|The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.|1 Year|Male and female patients were included, where the urodynamics tracings were compared against the Tetra NIRS tracings.|||participants|||Number
2750526|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
2750527|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
2750528|NCT00871871|Primary|Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.|90 -120 minutes post-dose|Number of participants who took ISMN/placebo.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
2750529|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)|Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.|||ng/minute||Standard Deviation|Least Squares Mean
2750530|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
2750531|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.|||ng/minute||Standard Deviation|Least Squares Mean
2750537|NCT00871780|Secondary|Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48|To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 - speed at baseline)/speed at baseline*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n= number of participants with evaluable data at time point.|||participants|||Number
2750538|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750539|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750540|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750541|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750542|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750543|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750544|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750545|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
2750546|NCT00871780|Primary|Change From Baseline in Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.|||units on a scale||Inter-Quartile Range|Median
2750547|NCT00871780|Primary|Change From Baseline in Maximum Walking Distance (MWD)||Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=those participants with observed data at given time point.|||meters||Inter-Quartile Range|Median
2750548|NCT00871780|Primary|Change From Baseline in the Timed 25-foot Walk Test (T25FW)|In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.|||seconds||Inter-Quartile Range|Median
2750575|NCT00871715|Secondary|Color Trails Making Tests 1 & 2||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750576|NCT00871715|Secondary|Hopkins Verbal Learning Test, Revised (HVLT-R)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750549|NCT00871780|Primary|Change From Baseline in the Timed 100-meter Walk Test (T100T)|In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.|||seconds||Inter-Quartile Range|Median
2750550|NCT00871741|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 9)|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2750551|NCT00871741|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2750552|NCT00871741|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature.~Any = any general symptom irrespective of intensity grade and relationship to vaccination.~Grade 3 Irritability = crying that could not be comforted/prevented normal activity.~Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination.~Subjects from Control Group did not receive the second study vaccination dose due to study termination."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2750553|NCT00871741|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|"The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.~Subjects from Control Group did not receive the second study vaccination dose due to study termination."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2750554|NCT00871741|Primary|Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL|As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.|At Month 3|||||||
2750555|NCT00871728|Secondary|Percentage of Participants Showing Mycological Cure|Mycological cure was defined as a case in which the results of both potassium hydroxide (KOH) smear test and bacterial identification test (BIT) were found to be negative at each pre-defined time point.|Week 13, 25, 37 and 49|The FAS population, missing values imputed using last observation carried forward (LOCF) method. 'n' included those participants who were evaluable for this measure at specific time points.|||percentage of participants|||Number
2750556|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 49 compared to Baseline were reported.|Baseline and Week 49|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
2750557|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 37 compared to Baseline were reported.|Baseline and Week 37|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
2750558|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 25 compared to Baseline were reported.|Baseline and Week 25|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
2750577|NCT00871715|Secondary|Digits Span Backward||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750578|NCT00871715|Secondary|D-KEFS Verbal Fluency Test||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750559|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 13 compared to Baseline were reported.|Baseline and Week 13|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
2750560|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 9 compared to Baseline were reported.|Baseline and Week 9|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
2750561|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 5 compared to Baseline were reported.|Baseline and Week 5|The Full analysis set (FAS) population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
2750562|NCT00871715|Other Pre-specified|Exit Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Post-intervention to 1 year post-randomization||2019-07-31|07/2019||||
2750563|NCT00871715|Other Pre-specified|Post-Intervention Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|16-20 weeks post-randomization||2019-07-31|07/2019||||
2750564|NCT00871715|Other Pre-specified|Monthly Telephone Interviews|A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|monthly, beginning 30 days post-randomization||2019-07-31|07/2019||||
2750565|NCT00871715|Secondary|Reintegration to Normal Living Index (RNLI)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750566|NCT00871715|Secondary|Single-Item Subjective Quality of Life Measurement (SQOL)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750567|NCT00871715|Secondary|Satisfaction With Life Scale (SWLS)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750568|NCT00871715|Secondary|EQ5D||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750569|NCT00871715|Secondary|Motor Activity Log 28 QOM (MAL-28)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750570|NCT00871715|Secondary|Stroke Impact Scale (SIS) Emotion Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||units on a scale||Standard Deviation|Mean
2750571|NCT00871715|Secondary|Stroke Impact Scale (SIS) Communication Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||units on a scale||Standard Deviation|Mean
2750572|NCT00871715|Secondary|Confidence in Arm & Hand Movement (CAHM)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750573|NCT00871715|Secondary|Patient Health Questionnaire 9 (PHQ-9)||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750574|NCT00871715|Secondary|Short Blessed Memory Test||Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750581|NCT00871715|Secondary|Arm Muscle Torque Test - Wrist Flexors|Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||kilograms||Standard Deviation|Mean
2750582|NCT00871715|Secondary|Arm Muscle Torque Test - Wrist Extensors|Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||kilograms||Standard Deviation|Mean
2750583|NCT00871715|Secondary|Arm Muscle Torque Test - Shoulder Flexors|Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||kilograms||Standard Deviation|Mean
2750584|NCT00871715|Secondary|Arm Muscle Torque Test - Shoulder Extensors|Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||kilograms||Standard Deviation|Mean
2750585|NCT00871715|Secondary|Arm Muscle Torque Test - Elbow Flexors|Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||kilograms||Standard Deviation|Mean
2750586|NCT00871715|Secondary|Arm Muscle Torque Test - Elbow Extensors|Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||kilograms||Standard Deviation|Mean
2750587|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength|Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.|Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750588|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box|Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.|Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2750589|NCT00871715|Secondary|National Institute of Health Stroke Scale (NIHSS)|Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||score on a scale||Standard Deviation|Mean
2750590|NCT00871715|Secondary|Stroke Impact Scale (SIS) ADL/IADL Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||units on a scale||Standard Deviation|Mean
2750591|NCT00871715|Secondary|Stroke Impact Scale (SIS) Mobility Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||units on a scale||Standard Deviation|Mean
2750592|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)|Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.|Baseline to 1 year post-randomization||2019-07-31|07/2019||||
2751496|NCT00864708|Secondary|Fugl-Meyer Lower Extremity Score|Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).|Day 1 and at 3 months, following treatment||||units on a scale|||Number
2750593|NCT00871715|Primary|Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)|The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||percentage of participants|||Number
2750594|NCT00871715|Primary|Stroke Impact Scale (SIS) Hand Function Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||units on a scale||95% Confidence Interval|Mean
2750595|NCT00871715|Primary|Wolf Motor Function Test Time|Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||seconds||95% Confidence Interval|Mean
2750596|NCT00871715|Primary|Wolf Motor Function Test (WMFT) Log-transformed Time|Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||log(seconds)||95% Confidence Interval|Mean
2750597|NCT00871689|Secondary|Number of Patients With Successful Natural Killer Expansion|Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl.|Day 72 Post Transplant||||participants|||Number
2750598|NCT00871689|Secondary|Median Overall Survival|Average number of days the patients were alive after receiving UCB transplantation.|Month 6||||Days||Full Range|Median
2750599|NCT00871689|Primary|Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant||||participants|||Number
2750600|NCT00871689|Secondary|Number of Patients With Complete Remission of Disease|Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis).|Day 100||||Participants|||Number
2750601|NCT00871689|Secondary|Number of Patients With Transplant-Related Death (TRD)|Number of patients whose death is related to study treatment received. TRD is defined as the number of patients that die without prior relapse.|1 Year Post Transplant||||Participants|||Number
2750602|NCT00871689|Secondary|Number of Patients With Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant||||participants|||Number
2750603|NCT00871689|Secondary|Incidence of Primary Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.|Day 42||||Participants|||Number
2750604|NCT00871689|Primary|Number of Patients With Neutrophil Engraftment|Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.|Day 42||||Participants|||Number
2750605|NCT00871624|Secondary|Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive|Percentage of time spent at desired sedation goal|Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study||||percentage of time||95% Confidence Interval|Median
2750606|NCT00871624|Primary|Tolerability of NIV as Assessed by an NIV Tolerance Score|NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)|Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours||||percentage of time spent tolerant to NIV||Inter-Quartile Range|Median
2750607|NCT00871572|Secondary|Change From Baseline to Endpoint for Total Cholesterol|Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting total cholesterol measurement and analyzed according to the assigned treatment; LOCF.|||mmol/L||Standard Error|Least Squares Mean
2750608|NCT00871572|Secondary|Change From Baseline to Endpoint for Non-HDL Cholesterol|Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting non-HDL cholesterol measurement and analyzed according to the assigned treatment; LOCF.|||mmol/L||Standard Error|Least Squares Mean
2750609|NCT00871572|Secondary|Change From Baseline to Endpoint for High Density Lipoprotein (HDL)|Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting HDL measurement and analyzed according to the assigned treatment; LOCF.|||mmol/L||Standard Error|Least Squares Mean
2750610|NCT00871572|Secondary|Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)|Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting LDL measurement and analyzed according to the assigned treatment; last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
2750611|NCT00871572|Secondary|Change From Baseline for C-Peptide AUC From OGTT|LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: all randomized participants with at least 1 post baseline C-peptide AUC from OGTTmeasurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
2750612|NCT00871572|Secondary|Change From Baseline for Insulin AUC From OGTT|LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline AUC from OGTT measurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
2750613|NCT00871572|Secondary|Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting GLP-1 measurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
2750614|NCT00871572|Secondary|Change From Baseline Values for Fasting Glucagon|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting glucagon measurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
2750615|NCT00871572|Secondary|Change From Baseline Values for Fasting Insulin|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting insulin measurement and analyzed according to the assigned treatment.|||picomole/liter (pmol/L)||95% Confidence Interval|Least Squares Mean
2750616|NCT00871572|Secondary|Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles|Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline 7-Point SMBG measurement and analyzed according to the assigned treatment.|||milligrams/deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2750617|NCT00871572|Secondary|Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)|The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline Diabetes Medicines Survey measurement and analyzed according to the assigned treatment.|||units on a scale||Standard Deviation|Mean
2750618|NCT00871572|Secondary|Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)|The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline DSC-R measurement and analyzed according to the assigned treatment.|||units on a scale||Standard Deviation|Mean
2750619|NCT00871572|Secondary|Change From Baseline to Endpoint for Fasting Triglycerides|LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting triglyceride measurement and analyzed according to the assigned treatment.|||mmol/L||Standard Error|Least Squares Mean
2750620|NCT00871572|Secondary|Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)|LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline OGTT measurement and analyzed according to the assigned treatment.|||mmol/L||95% Confidence Interval|Least Squares Mean
2750621|NCT00871572|Secondary|Change From Baseline Values for Fasting Blood Glucose (FBG)|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline FBG measurement and analyzed according to the assigned treatment.|||millimoles/liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2750856|NCT00869609|Secondary|Change in Triglycerides|Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mg/dl||Standard Deviation|Mean
2750622|NCT00871572|Primary|Mean Change in Glycosylated Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|Modified Intent-to-Treat (mITT): All randomized participants with at least 1 post baseline HbA1c measurement and analyzed according to the assigned treatment.|||percentage of HbA1c||90% Confidence Interval|Least Squares Mean
2750623|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."|||percentageof participants||95% Confidence Interval|Number
2750624|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2750625|NCT00871494|Secondary|Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2750626|NCT00871494|Primary|Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2750627|NCT00871429|Secondary|Percentage of Subjects With Skin Toxicity Grades 0 to 5 Using The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 at Baseline Visit and 1 Month Follow-up After Using Lindi Products.||one month|||||||
2750628|NCT00871429|Primary|Product Satisfaction of the Following Test Articles A, B, and C: Lindi Skin Soothing Balm (Product A), Lindi Skin Face Serum (Product B), and Lindi Skin Face Wash (Product C)||one month of use|the number of participants for analysis was determined per protocol.|||Percentage of Participants|||Number
2750629|NCT00871403|Secondary|Percentage of Participants With a Complete Response or a Partial Response|The percentage of participants with a complete response or a partial response was evaluated.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population|||percentage of participants|||Number
2750630|NCT00871403|Secondary|Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only|Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.|||participants|||Number
2750631|NCT00871403|Secondary|Overall Survival (OS)|OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.|Randomization until death (up to 85 weeks)|ITT Population||||||
2750632|NCT00871403|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).|Randomization until progression or death (up to 85 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||weeks||95% Confidence Interval|Median
2750633|NCT00871377|Primary|Seizure Frequency|Seizure frequency (seizures per day or seizures per month)|Study completion (42 weeks)||||Seizures per Day||Standard Error|Mean
2750634|NCT00871351|Secondary|Percent Change in Total Lipids and Hs-CRP|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).|End of washout to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
2750635|NCT00871351|Secondary|Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.|End of Week 4 to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
2750636|NCT00871351|Secondary|Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values|"LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).~Target values:~For participants with history of coronary artery disease: <100 mg/dL;~for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;~for participants with 1-2 CV risk factors: <140 mg/dL;~for participants with no CV risk factors: <160 mg/dL."|Week 16 or discontinuation|Randomized participants|||Participants|||Number
2750637|NCT00871351|Secondary|Percent Change in LDL-C|LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).|End of washout period to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
2750638|NCT00871351|Primary|Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values|LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).|End of Week 4 to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
2750639|NCT00871338|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Subjects|||Number
2750640|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.|||Subjects|||Number
2750641|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.|||Subjects|||Number
2750642|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.|||Subjects|||Number
2750643|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.|||Subjects|||Number
2750644|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.|||Subjects|||Number
2750802|NCT00870194|Secondary|Incidence of Hypoglycemia (Overall)|Incidence of hypoglycemic episodes experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; not confirmed with blood glucose values.|||Participants|||Number
2750645|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.|||Subjects|||Number
2750646|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PSC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750647|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PRP Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750648|NCT00871338|Secondary|Number of Subjects With a Booster Response to rSBA-MenC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750649|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||titers||95% Confidence Interval|Geometric Mean
2750650|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2750651|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||IU/mL||95% Confidence Interval|Geometric Mean
2750652|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||µg /mL||95% Confidence Interval|Geometric Mean
2750653|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||titers||95% Confidence Interval|Geometric Mean
2750654|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||µg /mL||95% Confidence Interval|Geometric Mean
2750655|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750656|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2752003|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 1|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 1|FAS (LOCF)|||participants|||Number
2750657|NCT00871338|Secondary|Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750658|NCT00871338|Secondary|Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750659|NCT00871338|Secondary|Number of Seropositive Subjects Against rSBA-MenC.|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750660|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-PRP.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
2750661|NCT00871338|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||µg/mL||95% Confidence Interval|Geometric Mean
2750662|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||titers||95% Confidence Interval|Geometric Mean
2750663|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2750664|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||IU/mL||95% Confidence Interval|Geometric Mean
2750665|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||µg/mL||95% Confidence Interval|Geometric Mean
2750666|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||titers||95% Confidence Interval|Geometric Mean
2750667|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||µg/mL||95% Confidence Interval|Geometric Mean
2750668|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
2750669|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
2750670|NCT00871338|Secondary|Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
2750671|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
2750672|NCT00871338|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
2750673|NCT00871338|Secondary|Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.|The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
2750674|NCT00871338|Primary|Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Participants|||Count of Participants
2750675|NCT00871338|Primary|Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Participants|||Count of Participants
2750676|NCT00871286|Primary|Number of Participants Having a CT Done|Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.|8 weeks|Per protocol; this was a nonpowered convenience sample|||participants|||Number
2750677|NCT00871286|Primary|Number of Participants in Compliance With Medical Recommendations|Number of participants in each group who complied with medical advice given at the initial appointment.|8 weeks||||participants|||Number
2750678|NCT00871234|Secondary|Endothelial Activation Biomarkers||Four weeks|||||||
2750679|NCT00871234|Secondary|Inflammatory Biomarkers||Four weeks|||||||
2750680|NCT00871234|Secondary|Blood Pressure||Four weeks|||||||
2750681|NCT00871234|Secondary|Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]||Four weeks|||||||
2750682|NCT00871234|Secondary|Lipid Fractions||Four weeks|||||||
2750683|NCT00871234|Primary|Flow-mediated Dilation (FMD) of the Brachial Artery|FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.|Entry and four weeks|FMD analysis was per protocol restricted to those who completed the four week trial. The safety analysis was ITT.|||Percentage||Inter-Quartile Range|Median
2750684|NCT00871169|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events, and Serious Adverse Events (SAEs)).|2 years||||participants|||Number
2750685|NCT00871169|Primary|Overall Response Rate (ORR)|ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.|2 years||||percentage of participants||95% Confidence Interval|Number
2750686|NCT00871143|Secondary|Body Image Quality of Life Inventory (BIQLI)|The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from -3 ('very negative effect') to +3 ('very positive effect'); Cronbach's α for the scale is 0.95.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
2750687|NCT00871143|Secondary|Generalised Anxiety Disorder (GAD)-7|The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach's α for the measure is 0.92.|12 weeks,1 month post treatment||||units on a scale||Standard Deviation|Mean
2750688|NCT00871143|Secondary|Patient Health Questionnaire (PHQ)-9|The PHQ is a 9-item self-report measure of depression; each item is scored from 0 ('not at all') to 3 ('nearly every day'),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach's α for the scale is 0.89.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
2750689|NCT00871143|Secondary|Appearance Anxiety Inventory (AAI)|The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 ('not at all') to 4 ('all the time'), and the range of the total scores is 0-40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach's α of 0.86.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
2750690|NCT00871143|Secondary|Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).|MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating 'normal' or 'no difficulties') to 6, and the range is 0-60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of >31 as severe.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
2750691|NCT00871143|Secondary|Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)|BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. 'I am as ugly as the Elephant man'); each item is rated from 0 ('non-delusional belief, or least pathological') to 4 ('delusional belief, or most pathological') and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
2750692|NCT00871143|Primary|Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)|This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to 'much improved' on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
2750693|NCT00871117|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to 6 months post-vaccination)|Analysis was performed on the total vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data was available.|||Participants|||Count of Participants
2750694|NCT00871117|Secondary|Number of Subjects With Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|Analysis was performed on the total vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data was available.|||Participants|||Count of Participants
2750695|NCT00871117|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms included fever [temperature equal to or greater than 37.5 degrees Celsius (°C)], drowsiness and loss of appetite. Any was defined as incidence of a particular symptom regardless of intensity grade.|Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|The analysis was performed on the total vaccinated cohort, which included subjects with at least one vaccine administration documented, only on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2750696|NCT00871117|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Any was defined as incidence of a particular symptom regardless of intensity grade.|Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|The analysis was performed on the total vaccinated cohort, which included subjects with at least one vaccine administration documented, only on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2750697|NCT00871117|Secondary|Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Seropositivity was defined as a concentration greater than or equal to 5.0 EL.U/mL|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750698|NCT00871117|Secondary|Number of Subjects Protected Against Poliovirus 1, 2 and 3|"Seroprotection was defined:~* anti-poliovirus type 1, 2 or 3 antibody titer greater than or equal to 8 ED50.~ED50 is defined here as the reverse of the dilution resulting in 50% inhibition."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750747|NCT00870740|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.|Up to 72 Weeks|Number of participants in the safety population (all randomized participants who received study treatment) with at least one post-baseline value.|||participants|||Number
2750699|NCT00871117|Secondary|Number of Subjects Seroprotected Against Diphteria and Tetanus|"Seroprotection status was defined as:~anti-D antibody concentration greater than or equal to 0.1 IU/mL~anti-T antibody concentration greater than or equal to 0.1 IU/mL"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750700|NCT00871117|Secondary|Number of Subjects With an Anti-polio 1, 2, 3 Booster Response|"Anti-poliovirus 1, anti-poliovirus 2 and anti-poliovirus 3 booster response:~initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ≥ 32 ED50 one month after vaccination~initially seropositive subjects (pre-booster antibody titers ≥ 8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination.~ED50 is defined here as the reverse of the dilution resulting in 50% inhibition. The lowest dilution at which serum samples were tested is 1:8 from which a test was considered positive."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750701|NCT00871117|Secondary|GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies|Concentrations are expressed as GMCs in Enzyme-Linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2750702|NCT00871117|Secondary|Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies|Concentrations were expressed as GMCs in IU/mL.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2750703|NCT00871117|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value|Cut-off value was defined as greater than or equal to 1.0 international units per milliliter (IU/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750704|NCT00871117|Primary|Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3|Titers are expressed as GMTs.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
2750705|NCT00871117|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)|"anti-PT, anti-FHA and anti-PRN booster response :~initially sero- (pre-booster antibody concentration below cut-off < 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL)~initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and < 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster~initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750706|NCT00871117|Primary|Number of Subjects With Booster Responses to Diphteria and Tetanus|"Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as:~initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of < 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL)~initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2750707|NCT00871000|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (from Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2750708|NCT00871000|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2750709|NCT00871000|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2750710|NCT00871000|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2750711|NCT00871000|Secondary|Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella|Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750712|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN|Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750713|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3|Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750714|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-D and Anti-T|Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750715|NCT00871000|Secondary|Anti-rubella Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2750716|NCT00871000|Secondary|Anti-mumps Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||U/mL||95% Confidence Interval|Geometric Mean
2750717|NCT00871000|Secondary|Anti-measles and Anti-varicella Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2750718|NCT00871000|Secondary|Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella|Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750738|NCT00870870|Secondary|Number of Participants With Adverse Events (AEs) or Deaths|Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.|Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up|All randomized participants.|||Participants|||Count of Participants
2750719|NCT00871000|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750720|NCT00871000|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2750721|NCT00871000|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750722|NCT00871000|Primary|Number of Seropositive Subjects for Anti-D and Anti-T Antibodies|A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750723|NCT00871000|Primary|Number of Seroprotected Subjects Against Polio Types 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2750724|NCT00871000|Primary|Anti-poliovirus Types 1, 2 and 3 Antibody Titres|Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
2750725|NCT00871000|Primary|Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2750726|NCT00870896|Secondary|Change in FEV1/FVC Ratio|We measured the change in FEV1/FVC ratio at baseline and following 30 days of treatment with Spiriva.Change in ratio reflects the percentage value (ratio) at 30 days minus the percentage value (ratio) at baseline x 100|30 days||||percentage change||Standard Deviation|Mean
2750727|NCT00870896|Secondary|Change in FEV1 (in Liters)|Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.|||liters||Standard Deviation|Mean
2750728|NCT00870896|Primary|Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days)|We measured the change in the number of coughs following capsaicin inhalation challenge from baseline followed by 30 days of treatment with spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.|||coughs per dose of capsaicin||Standard Deviation|Mean
2750729|NCT00870870|Secondary|Cmin of Cixutumumab for Cycle 5||Week 13 (Cycle 5, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2750730|NCT00870870|Secondary|Cmin of Cixutumumab for Cycle 3||Week 7 (Cycle 3, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2750731|NCT00870870|Secondary|Cmin of Cixutumumab for Cycle 1||Week 1 (Cycle 1, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2750732|NCT00870870|Secondary|Minimum Concentration (Cmin) of Cixutumumab at Study Day 1||Day 1|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2750733|NCT00870870|Secondary|Cmax of Cixutumumab Cycle 5||Week 13 (Cycle 5, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2750734|NCT00870870|Secondary|Cmax of Cixutumumab for Cycle 3||Week 7 (Cycle 3, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
2750739|NCT00870870|Secondary|Duration of Response|The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.|Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)|All pts randomized to GCiC and GCiC Plus Cixutumumab arms and who had CR or PR, except 1 pt in GCiC group eliminated d/t PR after starting additional treatment. Participants censored: GCiC = 0, GCiC Plus Cixutumumab = 1. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) due to the amended protocol.|||months||95% Confidence Interval|Median
2750740|NCT00870870|Secondary|Time To Progression (TTP)|TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.|Randomization to months until PD or censor (up to 16.9 months)|All participants (pts) randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 9, GCiC Plus Cixutumumab = 12. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||months||95% Confidence Interval|Median
2750741|NCT00870870|Secondary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.|Randomization to PD or death due to any cause or censor (up to 16.9 months)|All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 2, GCiC Plus cixutumumab = 10. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||months||95% Confidence Interval|Median
2750742|NCT00870870|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.|Randomization to death due to any cause or censor (up to 30.4 months)|All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 6, GCiC Plus cixutumumab = 6. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||months||95% Confidence Interval|Median
2750743|NCT00870870|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100.|Randomization to measured progressive disease (PD) (up to 16.9 months)|All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||percentage of participants||95% Confidence Interval|Number
2750744|NCT00870740|Secondary|Rate of Percentage Change From Baseline in Mean Total Brain Volume|Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.|||rate of percentage change||95% Confidence Interval|Number
2750745|NCT00870740|Primary|Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline|Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|All participants in the Safety Population (all randomized participants who received study treatment) with a post-baseline ADAb assessment.|||participants|||Number
2750746|NCT00870740|Primary|Number of Participants With Abnormalities in Blood Chemistry Laboratory Data|For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.|Up to 72 Weeks|Safety Population: all randomized participants who received study treatment; n=number of participants whose baseline value for 205MS202 (NCT00870740) was normal (i.e. not high or low) and who had at least one post-baseline value during the study.|||participants|||Number
2750972|NCT00868517|Secondary|Fragmented Sleep Patterns-Sleep Efficiency|Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months||||percentage of TST to time in bed||95% Confidence Interval|Mean
2750748|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.|||percentage change in volume||Standard Deviation|Mean
2750749|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.|||percentage change in volume||Standard Deviation|Mean
2750750|NCT00870740|Secondary|Mean Volume of New T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 20, Week 52|Per-protocol population: randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days; n=participants with measurement at given time point.|||mm^3||Standard Deviation|Mean
2750751|NCT00870740|Secondary|Mean Number of New or Newly-enlarging T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Baseline, Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||lesions||Standard Deviation|Mean
2750752|NCT00870740|Secondary|Mean Number of New Gadolinium-enhancing Lesions|Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||lesions||Standard Deviation|Mean
2750753|NCT00870740|Secondary|Estimated Proportion of Participants With a Relapse|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||proportion of participants|||Number
2750754|NCT00870740|Secondary|Adjusted Annualized Relapse Rate|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||relapses per person-years||95% Confidence Interval|Number
2750973|NCT00868517|Secondary|Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture||t= 2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.|||participants|||Number
2750755|NCT00870740|Primary|Number of Participants With Abnormalities in Vital Signs|For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.|Up to Week 72|Safety population: all randomized participants who received study treatment; n=number of subjects who had a baseline assessment and at least one post-baseline assessment for that vital sign.|||participants|||Number
2750756|NCT00870740|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.|Up to 72 weeks|Safety population: all randomized participants who received study treatment. Participants who discontinued study treatment due to an AE and/or withdrew from the study due to an AE that started prior to 205MS202 (NCT00870740) and that was treatment-emergent under 205MS201 (NCT00390221) are included in this summary.|||participants|||Number
2750757|NCT00870727|Secondary|Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Stereotypy subscale is 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants|||units on a scale||95% Confidence Interval|Mean
2750758|NCT00870727|Secondary|Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Social Withdrawal subscale is 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants|||units on a scale||95% Confidence Interval|Mean
2750759|NCT00870727|Secondary|Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Inappropriate Speech subscale is 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants|||units on a scale||95% Confidence Interval|Mean
2750760|NCT00870727|Secondary|Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores is 0 to 48 on the Hyperactivity subscale. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants|||units on a scale||95% Confidence Interval|Mean
2750761|NCT00870727|Primary|Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Irritability subscale is 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants|||units on a scale||95% Confidence Interval|Mean
2752004|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 2|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 2|FAS (LOCF)|||participants|||Number
2750762|NCT00870727|Primary|Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)|Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one participant assigned to aripiprazole withdrew from the study without completing an exit interview.|Double-blind phase study exit - up to 8 weeks|All randomized study participants who completed an exit interview|||participants|||Number
2750763|NCT00870688|Primary|Number of Seizures Within 7 Weeks||7 weeks||||seizures||Standard Deviation|Mean
2750764|NCT00870688|Secondary|Data About Efficacy, Safety and Compliance||7 weeks|||||||
2750765|NCT00870688|Primary|Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily||7 weeks|||||||
2750766|NCT00870584|Secondary|Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks|"The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study? The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment."|24 weeks|Full Analysis Set|||participants|||Number
2750767|NCT00870584|Primary|Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.|Baseline and 24 weeks|"The Full Analysis Set consisted of patients to whom study drug had been assigned through randomization. Patients inappropriately randomized were excluded from this analysis set.~Participants with observations at both baseline and 24 weeks were included in the analysis."|||Score on a scale||Standard Deviation|Mean
2750768|NCT00870545|Secondary|Family Communication|Family communication measured with the Family Problem Solving Communication scale at baseline, six and 12 months. Scores range from 0-30 with higher scores indicating better communication.|baseline, 6 months, and 12 months|All participants with family communication data at baseline, six and 12 months.|||units on a scale||Standard Deviation|Mean
2750769|NCT00870545|Secondary|Spouse Social Support|Support measured with the Social Support Index at baseline, six and 12 months. Scores range from 0-68 with higher scores indicating better social support.|baseline, 6 months, and 12 months|All participants with social support data at baseline, six and 12 months.|||units on a scale||Standard Deviation|Mean
2750770|NCT00870545|Primary|Quality of Marriage|Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months. Scores range from 6-45 with higher scores indicating better quality of marriage.|Baseline, 6 and 12 months|All participants with quality marriage index scores at the three time points|||units on a scale||Standard Deviation|Mean
2750771|NCT00870545|Primary|Anxiety|Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months. Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.|baseline, 6 months and 12 months|All participants with anxiety scores at 12 months|||units on a scale||Standard Deviation|Mean
2750772|NCT00870545|Secondary|Family Coping|Family problem solving measured at baseline, six and 12 months with the F-COPES measure. Scores range from 29-145 with higher scores indicating better coping.|Baseline, 6 months and 12 months|All participants with family coping data at baseline, six and 12 months.|||units on a scale||Standard Deviation|Mean
2750773|NCT00870545|Primary|Spouse Self-report of Depression|Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months. Scores range from 0-27 with lower scores indicating less depressive symptoms.|Baseline, 6 months, and 12 months|All participants with depression data at baseline, six and twelve months|||units on a scale||Standard Deviation|Mean
2750774|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.|Through Week 52|Participants who received at least 1 dose of adalimumab during the study.|||participants|||Number
2750775|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
2750776|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||units on a scale||Standard Deviation|Mean
2750777|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
2750778|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
2750779|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
2750780|NCT00870467|Secondary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 52|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 52|Participants who completed 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||units on a scale||Standard Deviation|Mean
2750781|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.|Through Week 26|All participants who received at least 1 dose of double-blind study drug.|||participants|||Number
2750782|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
2750783|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Last observation carried forward (LOCF) was used for missing data.|||units on a scale||Standard Deviation|Mean
2750784|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
2750785|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
2750786|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
2750787|NCT00870467|Primary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 26|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Analysis performed using observed cases; no imputation technique used. Participants who switched to open-label adalimumab before Week 26 were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2750788|NCT00870363|Secondary|Immune Reconstitution With Respect to Absolute Numbers of CD4+ T-cells, the Relative Proportion of T-cell Subpopulations in the Tissue, and Immune Activation to a Cohort of Normal Controls||nine months|data was not collected/analyzed due to complications in the assays for immune activation in the collected samples||||||
2750789|NCT00870363|Secondary|Changes in CD4+ T-cell Numbers by Treatment Regimen|peripheral absolute CD4+ T-cell counts increase from baseline to 9 months of cART by commercial assay|Baseline and nine months|peripheral CD4 T-cell counts were not measured in the HIV negative cohort|||cells/mL||95% Confidence Interval|Mean
2750790|NCT00870363|Secondary|Lymphocyte Immune Function and Activation at Two Time Points Approximately Nine Months Apart in GALT; and Four Timepoints (Month 0, 3, 6, and 9) in Peripheral Blood||nine months|data were not collected due to inadequate sample volume for this complex experiment design||||||
2750791|NCT00870363|Secondary|Change in GALT CD4+ and CD8+ T-cell Subpopulations (naïve and Memory Subsets)||nine months|data were not collected due to the samples not being suitable for the epitopes being measured||||||
2750792|NCT00870363|Secondary|Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received|single-cell suspension of digested duodenal tissue and Ficol-Hypaque separated PBMC underwent HIV-DNA PCR|Baseline and nine months|HIV negative controls did not have HIV-DNA in blood or tissue|||copies/10^6 cells||95% Confidence Interval|Mean
2750793|NCT00870363|Secondary|Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy|The reported drug level is for the primary ART agent for that cohort. For the maraviroc arm, maraviroc plasma and tissue levels are reported. For the maraviroc plus raltegravir arm, the raltegravir plasma and tissue levels are reported. For the efavirenz arm, the efavirenz plasma and tissue levels are reported. HIV negative controls were not on ART and did not have drug levels measured.|nine months|HIV negative controls were not on ART and did not have drug levels measured.|||ng/mL||Inter-Quartile Range|Median
2750794|NCT00870363|Primary|Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen|immunohistochemistry for CD3+/CD4+ cells counted manually within the lamina propria|Baseline and nine months for 3 treatment cohorts and Baseline for the control group, which was only assessed at one time point|numbers represent an increase from baseline for the 3 treatment cohorts and represent the absolute value for the control group who were only measured at one timepjoint.|||cells/mm^2||95% Confidence Interval|Mean
2750795|NCT00870233|Secondary|Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System|The percentage of symptoms generated by patients on protocol|weekly starting 7 days after surgery until the 6-week post-operative period||||percentage of symptoms|||Number
2750796|NCT00870233|Secondary|To Evaluate the Impact of Online Symptom Self-reporting on Patient Care Processes as Measured by the Number of Telephone Calls Between Nurses and Patients,Resulting Interventions and Patient Satisfaction With Care Delivery.||two years|Data were not collected||||||
2750797|NCT00870233|Secondary|Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.||once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended|Nurses who participated in the study|||Participants|||Count of Participants
2750798|NCT00870233|Primary|Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery||once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.||||Participants|||Count of Participants
2750799|NCT00870194|Secondary|Incidence of Confirmed Hypoglycemia(Overall)|Incidence of confirmed hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; has a concurrent fingerstick blood glucose <3.0 mmol/L (54 mg/dL).|||Participants|||Number
2750800|NCT00870194|Secondary|Incidence of Nocturnal Hypoglycemia (Overall)|Incidence of nocturnal hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients|||Participants|||Number
2750801|NCT00870194|Secondary|Incidence of Severe Hypoglycemia(Overall)|Incidence of severe hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Severe hypo:symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose;or documented hypoglycemia (BG< 3.0 mmol/L [54/mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior|||Participants|||Number
2750803|NCT00870194|Secondary|Change in Total Cholesterol (mmol/L)|Change in total cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
2750804|NCT00870194|Secondary|Change in LDL (mmol/L)|Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
2750805|NCT00870194|Secondary|Change in HDL (mmol/L)|Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
2750806|NCT00870194|Secondary|Change in Triglycerides (mmol/L)|Change in triglycerides from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
2750807|NCT00870194|Secondary|SMBG (mmol/L)|7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
2750808|NCT00870194|Secondary|Waist-to-Hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (Week20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Ratio||Standard Error|Least Squares Mean
2750809|NCT00870194|Secondary|Change in Waist Circumference (cm)|Change in waist circumference from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||cm||Standard Error|Least Squares Mean
2750810|NCT00870194|Secondary|Change in Body Weight (kg)|Change in body weight from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||kg||Standard Error|Least Squares Mean
2750811|NCT00870194|Secondary|Change in FSG (mmol/L)|Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
2750812|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 6.5%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage|||Number
2750813|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <7.0%|Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was >= 7.0%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage|||Number
2750814|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=7.0%|Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage|||Number
2750815|NCT00870194|Primary|Change in HbA1c (Percent)|Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percent HbA1c||Standard Error|Least Squares Mean
2750816|NCT00870103|Primary|The Percentage of Patients With no Ocular Pain||Day 15 after cataract surgery||||Percentage of participants|||Number
2750817|NCT00870103|Primary|The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.|"The percentage of patients with a score of zero for Anterior chamber cells.~Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).~Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon"|Day 15 after cataract surgery||||Percentage of participants|||Number
2750829|NCT00869947|Secondary|Trailing Leg Step-to-step Transition Work|We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).|1 year||||J/kg||Standard Error|Mean
2752005|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 1|Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg|baseline, week 1|FAS (LOCF)|||participants|||Number
2750818|NCT00869999|Primary|Overall Response Rate|Complete response plus partial response after 6 cycles. Response rate will be evaluated by using the modified Cheson criteria for lymphoma response. Complete response requires all of the following: 1) PET positive prior to therapy: mass of any size permitted if PET negative. Variable FDG-avid or PET negative prior to therapy: regression to normal size on CT (</= 1.5cm in their greatest transverse diameter for nodes >/= 1.5 cm before therapy) 2) Spleen (if enlarged before therapy) must have regressed in size and must not be palpable, 3) If bone marrow is known to be involved, repeat biopsy documents clearance. Partial response requires 1) >/= 50% decrease in SPD, 2) No new sites of disease or increase in the size of other nodes, liver or spleen, 3) Splenic and hepatic nodules must regress by at least 50% in SPD|Assessed at the conclusion of cycle 2, cycle 4 and cycle 6||||percentage of participants||90% Confidence Interval|Number
2750819|NCT00869999|Secondary|Progression-free Survival|Progression-free survival is defined as the duration of time from start of treatment to time of documentation of progression or death|2 years||||months||90% Confidence Interval|Median
2750820|NCT00869999|Secondary|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.|2 years||||months||90% Confidence Interval|Median
2750821|NCT00869960|Primary|Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750822|NCT00869960|Primary|Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750823|NCT00869960|Primary|Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750824|NCT00869960|Primary|Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750825|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750826|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750827|NCT00869960|Primary|Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|between time of dosing tp 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750828|NCT00869960|Primary|Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|between time of dosing to 24 hours after dose administered|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
2750831|NCT00869947|Primary|Metabolic Cost of Transport|We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).|1 year||||J/Nm||Standard Deviation|Mean
2750832|NCT00869791|Secondary|"Off Time Hours Reported by Subjects Using Parkinson's Patient Diary"|"Subjects recorded state of OFF time using the Parkinson's Patient Diary"|Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM|All treated patients|||hours||Standard Deviation|Mean
2750833|NCT00869791|Secondary|Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period|"To determine 8h efficacy on Day 1 the on site investigator assessments of ON, OFF and state of dyskinesia for each subject was collected predose (-1, -0.5, and 0 hours) every 30 min for up to 8 hours after dosing . For all subjects duration of (1) OFF time (2) ON time without dyskinesia, (3) ON time with non-troublesome dyskinesia and (4) ON time with troublesome dyskinesia was calculated for both treatments. Definition of ON was based on a 20% change from predose measure, and the results were analyzed in the standard manner of a two way crossover design. The trial inclusion criteria included ability of subject to differentiate ON state from OFF state per investigator's assessment."|Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period|For determining motor assessment of dyskinesia evaluated by investigator assessment a mixed-effect model was used with treatment, sequence, and period as factors and subjects within sequence as error term. The primary analysis was performed on the average of all times collected half hourly. Data for two patients was not collected, N25 instead of 27|||Hours||Standard Deviation|Mean
2750834|NCT00869791|Secondary|8-Hour Efficacy Using Day 1 Unified Parkinson's Disease Rating Scale Part III Score|To determine efficacy on Day 1 the UPDRS (unified Parkinson's disease rating) Part III score, a clinician-scored measure of motor function, was collected immediately predose and 1, 2, 3, 4, 5, 6, 7 and 8 h post dose. The UPDRS Part III motor exam analyzes multiple motor functions like speech, facial expression, tremor, rigidity, movement, posture, gait etc. Each parameter is assigned values from 0 to 4, with 0 being normal and 4 being the most affected. The total range is 0 - 108, with lower scores indicating a better outcome.The average of post dose was calculated for day 1.|Pre dosing and at hourly intervals through the 8-hour measurement period on day 1|Analysis of covariance was the primary analysis conducted on the mean UPDRS Part III across the 8-hour measurement period, with the predose UPDRS Part III value as a covariate. This analysis was repeated at each timepoint for completeness.|||UPDRS Part III Motor Score||Standard Deviation|Mean
2750835|NCT00869791|Secondary|8-Hour Efficacy Using Day 1 Tapping|"Improvement in Tapping: has been used as a surrogate endpoint for assessing subject being On. Finger Tapping: the number of times the subject could tap two counter keys 20 cm apart alternately in 1 minute with the most affected arm assessed every 30 minutes on Day 1. Subjects performed the 60-second tapping measurement three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period on Day 1 of each treatment period. More hours On during treatment represented better outcome. For the Tapping measurement, the protocol defined a 20% change from the average of the predose measurements as the time to On. Each half-hour interval counted as 0.5 hour. Any measurement below a 20% improvement was considered time Not On. If patient required redosing then primary analyses adjusted for redosing in calculating the results."|Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period|Analysis of covariance was the primary analysis conducted on the mean total Taps across the 8-hour measurement period, with the average of the three predose Tapping measurement values as a covariate.|||Hours||Standard Deviation|Mean
2750836|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Area under the concentration-time curve for the dosing interval (AUC Tau) in hour*nanogram/milliliter was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.|||hour*nanogram/milliliter||Standard Deviation|Mean
2750837|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Time of maximum drug concentration (Tmax in hours) was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.|||Hours||Standard Deviation|Mean
2750974|NCT00868517|Secondary|Attrition Rates|Examined attendance rates in attending group sessions to examine attrition rates.|t=2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.|||% of sessions attended||Standard Deviation|Mean
2750838|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD.14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.|||nanogram/milliliter||Standard Deviation|Mean
2750839|NCT00869778|Secondary|Change From Baseline by Visit for Serum HBV DNA|Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values|week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||IU/mL||Standard Deviation|Mean
2750840|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
2750841|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
2750842|NCT00869778|Secondary|Change From Baseline by Visit for HBeAg Titer|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population|||IU/mL||Standard Deviation|Mean
2750843|NCT00869778|Secondary|The Proportion of Patients With Positive Anti-HBe||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population|||percentage of participants|||Number
2750844|NCT00869778|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb;||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population|||percentage of participants|||Number
2750845|NCT00869778|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
2750846|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
2750847|NCT00869778|Secondary|Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication|serology response at week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
2750848|NCT00869778|Primary|Percentage of Participants With HBeAg Seroconversion at Endpoint .|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint(LOCF), up to 76 Weeks|Intention-To-Treat Population|||percentage of participants|||Number
2750849|NCT00869622|Secondary|Vertebral Fractures||2 years||||Vertebral Fractures|||Number
2750850|NCT00869622|Primary|Changes in Bone Mineral Density|"Patients with a T-Score of > -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D.~Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals."|2 years|The study design involved 80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate. This is a prospective study in which 80 patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.|||g/cm2||Standard Deviation|Mean
2750851|NCT00869609|Secondary|Change in Waist Circumference|Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||inches||Standard Deviation|Mean
2750852|NCT00869609|Secondary|Change in Diastolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mmHg||Standard Deviation|Mean
2750853|NCT00869609|Secondary|Change in Systolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mmHg||Standard Deviation|Mean
2750854|NCT00869609|Secondary|Change in Glycosylated Hemoglobin A1c (HbA1c)|Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2750855|NCT00869609|Secondary|Change in Fasting Glucose|Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mg/dl||Standard Deviation|Mean
2750857|NCT00869609|Secondary|Change in LDL Cholesterol|Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.|||mg/dl||Standard Deviation|Mean
2750858|NCT00869609|Secondary|Change in HDL Cholesterol|High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.|||mg/dl||Standard Deviation|Mean
2750859|NCT00869609|Secondary|Change in Total Cholesterol|Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.|||mg/dl||Standard Deviation|Mean
2750860|NCT00869609|Primary|Change in Weight|Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Intention to treat analyses were performed; for those with missing weights at the post-intervention, 8 and 12 month visits, the last documented observation was carried forward. This information was available from the session data, where weight was collected weekly.|||pounds||Standard Deviation|Mean
2750861|NCT00869557|Secondary|The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL|The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.|Baseline to Weeks 24 and 48|ITT analysis set|||percentage of participants|||Number
2750862|NCT00869557|Secondary|Change From Baseline in CD4 Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to Week 48|ITT analysis set; M = E analysis (all missing data were excluded from the analysis).|||cells/µL||Standard Deviation|Mean
2750863|NCT00869557|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24|Change = Week 24 value minus baseline value|Baseline to Week 24|ITT analysis set. M = E analysis (all missing data were excluded from the analysis).|||cells/µL||Standard Deviation|Mean
2750864|NCT00869557|Secondary|Change From Baseline in HIV-1 RNA (log_10 Copies/mL)|Change = Week 24 or 48 value minus baseline value|Baseline to Weeks 24 and 48|ITT analysis set; The missing = excluded (M = E) analysis method was used in which all missing data were excluded from the analysis.|||log_10 copies/mL||Standard Deviation|Mean
2750865|NCT00869557|Secondary|The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|Week 48|ITT analysis set; M = F analysis (all missing data were considered as failure [HIV-1 RNA ≥ 50 copies/mL]).|||percentage of participants|||Number
2750866|NCT00869557|Primary|The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.|Week 24|ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).|||percentage of participants|||Number
2750867|NCT00869518|Secondary|Recurrent Skin and Skin Structure Infections (SSTI)|recurrent SSTI was by self-report and exam, followed until positive colonization|up to 30 days following completion of treatment|participants were followed until colonization; therefore, no participants were followed past 30 days|||participants|||Number
2750868|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|60 days following completion of treatment|Participants were colonized at day 30 (i.e. S. Aureus not eradicated) and were not checked again for follow-up.||||||
2750869|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|7 days following completion of treatment||||participants|||Number
2750870|NCT00869518|Primary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|30 days following completion of treatment||||participants|||Number
2750871|NCT00869440|Secondary|Time to Ready for Discharge|Time to first of 3 consecutive Aldrete scores ≥9 after the end endoscopy procedure|From the end of the endoscopy procedure up to 120 minutes or until 3 consecutive Aldrete scores of ≥9 are reached, whichever occurs first|All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)|||minutes||Standard Deviation|Mean
2750872|NCT00869440|Secondary|Time to Fully Alert|Time to first of 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 following study drug administration in patients who underwent the endoscopy procedure|From study drug administration until fully alert criteria are reached|All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)|||minutes||Standard Deviation|Mean
2750873|NCT00869440|Primary|Success Rates of the Procedure|Success of the procedure is a composite endpoint consisting of: MOAA/S scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation|From start of study drug injection to patient discharge|All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)|||Participants|||Count of Participants
2750874|NCT00869414|Primary|Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.||6 weeks|This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available||||||
2750875|NCT00869414|Primary|Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)||6 weeks|This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available.||||||
2750876|NCT00869401|Secondary|Objective Response|Objective response to treatment will be determined by a combination of the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The proportion of patients in each response category will be summarized. Only phase II patients were evaluated for response.|Up to 5 years post treatment|Participants that have at least one disease evaluation for assessing best response to treatment.|||Proportion of participants|||Number
2750877|NCT00869401|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Only Phase II patients were evaluated for Progression-free survival|Up to 5 years post treatment|All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable|||Months||95% Confidence Interval|Median
2750878|NCT00869401|Primary|The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population.|Doselimiting toxicity will be defined as: Adverse event at least possibly related to the study medication. All by CTCAE v3.0 criteria: Greater than or equal to grade 3: diarrhea or skin rash or desquamation or (other) clinically relevant non-hematological adverse event or non-hematologic adverse event at least possibly due to drug therapy. Or greater than or equal to grade 4: neutropenia or leukopenia or thrombocytopenia or radiation dermatitis or hematologic adverse event OR failure to administer greater than 75% of dasatinib TMZ or interruption of RT for more than 5 days due to adverse events.OR severe acute central nervous system deterioration attributable to TMZ, RT and or dasatinib which cannot be controlled with corticosteroid administration. The MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT.|Every cycle from first dose to end of rest period prior cycle 3|Only Phase I patients were evaluated for maximum tolerable dose.|||participants with Dose Limiting Toxicits|||Number
2750879|NCT00869401|Primary|Overall Survival|Overall survival (OS) is the primary endpoint and is defined as the time from study registration to time of death due to any cause. All patients who meet the eligibility criteria, have signed a consent form, and have received at least one dose of the regimens will be considered evaluable. Patients who are lost to follow-up will be censored at the date of their last follow-up. Patients still alive at the time of analysis will be censored. Only Phase II was evaluated for survival|Up to 5 years post treatment||||Months||95% Confidence Interval|Median
2750880|NCT00869375|Primary|Incidence of Bleeding Complications||24 hours after the procedure||||participants|||Number
2750881|NCT00869375|Primary|Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence||24 hours after the procedure||||participants|||Number
2750882|NCT00869362|Secondary|Average Intervention Effect Over 12 Months After Hospital Discharge||12 months from discharge||||HbA1c, %||Standard Error|Mean
2750883|NCT00869362|Primary|Hemoglobin A1c|Change in glycemic control measured by HbA1c change baseline to 6 months|6 months from discharge||||HbA1c, %||Standard Deviation|Mean
2750884|NCT00869349|Secondary|Self-Compassion|Change in the Neff Self Compassion scale from baseline to 21-months. This is a 26-item scale. The total self-compassion score ranges from 0 (no self-compassion) - 30 (high self-compassion). Reference: Neff, K.D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.|||units on a scale||Standard Deviation|Mean
2750885|NCT00869349|Secondary|Depression|"Change in the Beck Depression Scale from baseline to 21-months. The BDI-II (Reference: BDI- II Manual by Aaron T. Beck, Robert A. Steer, and Gregory K. Brown) is a 21-item scale for measuring negative attitudes about the future. Add up each of the items marked in the direction keyed for hopelessness to get a total score.~Each of 21 items is summed to give single score for BDI-II.~There is 4-point scale ranging from 0 - 3. On 2 items (16, 18)~There are 7 options to indicate either increase or decrease of appetite and sleep. These are still scored 0 - 3 - answers are 0,1a,1b,2a,2b,3a,3b.~Cut score guidelines for the BDI-II are given with recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II.~0 - 13 minimal 14 - 19 mild 20 - 28 moderate 29 - 63 severe"|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.|||units on a scale||Standard Deviation|Mean
2750886|NCT00869349|Primary|RADAI Disease Activity Score|"Change in self-assessed disease activity from baseline to 21-months. Total RADAI score is 0-10 with 0 indicating no/low self-assessed disease activity and 10 indicating high self-assessed disease activity.~Reference: Stucki G, Liang M, Stucki S, Bruhlmann P, Michel BA. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiological research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum. 38;795-98,1995"|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.|||units on a scale||Standard Deviation|Mean
2750887|NCT00869323|Secondary|Overall Survival||at 2 years||||participants|||Number
2750888|NCT00869323|Secondary|Relapse-free Survival||at 2 years||||participants|||Number
2750889|NCT00869323|Secondary|Time to Treatment Failure||Day 1 to Time of Disease Progression|Two participants had a complete response at the time they completed the study and were not included in this outcome measure.|||months|||Number
2750890|NCT00869323|Secondary|Remission Duration Among Patients Who Respond to Treatment||Day 1 to 8 Months Post Treatment|Both of the participants who responded to treatment were in remission at last contact or death.|||months||Full Range|Median
2750891|NCT00869323|Primary|Number of Patients With Overall (Complete and Partial) Response Rates||Day 1 to 2 Years Post Treatment||||participants|||Number
2750892|NCT00869258|Primary|Conversion Rate of Inoperable to Operable|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks|||||||
2750925|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity."|24 weeks||||units on a scale||Standard Deviation|Mean
2750893|NCT00869206|Secondary|Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma)|To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here.|from baseline up to 24 months|74 multiple myeloma patients were treated and included in this portion of the substudy.|||Participants|||Count of Participants
2750894|NCT00869206|Secondary|Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer)|To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here.|from baseline up to 24 months|207 prostate cancer patients who were treated and included in this portion of the substudy.|||Participants|||Count of Participants
2750895|NCT00869206|Secondary|Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma|To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.|from baseline up to 24 months|265 patient completed treatment and were analyzed.|||Participants|||Count of Participants
2750896|NCT00869206|Secondary|Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer|To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with prostate cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.|from baseline up to 24 months|660 patients completed treatment and were analyzed.|||Participants|||Count of Participants
2750897|NCT00869206|Secondary|Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer|To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with breast cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.|from baseline up to 24 months|820 patients completed treatment and were analyzed.|||Participants|||Count of Participants
2750898|NCT00869206|Secondary|Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)|To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here.|from baseline up to 2 years|266 breast cancer patients who were treated and included in this portion of the substudy.|||Participants|||Count of Participants
2750899|NCT00869206|Secondary|Skeletal Morbidity Rate|To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.|from baseline up to 2 years|1766 patients were treated and analyzed.|||SRE's per year||Standard Deviation|Mean
2750900|NCT00869206|Secondary|Incidence of Renal Dysfunction|To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here.|from baseline up to 2 years|1689 patients completed treatment and were analyzed.|||percentage of participants|||Number
2750901|NCT00869206|Secondary|Incidence of Osteonecrosis of the Jaw|To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of participants with osteonecrosis is reported here.|from baseline up to 2 years|1766 patients completed treatment and were analyzed.|||percentage of participants|||Number
2750902|NCT00869206|Secondary|Average ECOG Performance Status|To compare functional status (ECOG performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm.|from baseline up to 2 years|1766 patients completed treatment and were analyzed.|||score on a scale||Standard Error|Mean
2750903|NCT00869206|Secondary|Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire|To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.|from baseline up to 2 years|1766 patients completed treatment and were analyzed.|||score on a scale||Standard Error|Mean
2750904|NCT00869206|Primary|Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization|To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.|2 years|All patients that were eligible and completed treatment were analyzed.|||percentage of participants|||Number
2750975|NCT00868517|Secondary|Hypnotic Medication Use|Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).|t=2 months||||participants|||Number
2750905|NCT00869167|Primary|Insomnia Severity Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.~PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|5 weeks|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||units on a scale||Standard Deviation|Mean
2750906|NCT00869167|Secondary|Daytime Lung Function (Peak Flow Monitoring) in Liter/Min||baseline and during treatment period (during 5th week)|This measure was added during the study and no subjects completed the measure.||||||
2750907|NCT00869167|Secondary|Daytime Performance (Digit Symbol Substitution Test)|"DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.~DSST score can range from 0-125, with 125 being the most number correct during the allotted time period."|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||Number correct||Standard Deviation|Mean
2750908|NCT00869167|Secondary|Daytime Sleepiness (Epworth Sleepiness Scale)|Score of 0-24, with 24 being the most sleepy|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||units on a scale||Standard Deviation|Mean
2750909|NCT00869167|Primary|Pittsburgh Sleep Quality Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.~PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||units on a scale||Standard Deviation|Mean
2750910|NCT00869141|Primary|Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase|intraocular pressure of eyes with hypertensive phase versus without hypertensive phase|1 year after surgery|Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.|||mmHg in 1 year postop||Standard Deviation|Mean
2750911|NCT00869141|Primary|Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma|intraocular pressure comparison between groups after the Ahmed valve implantation|3 weeks after surgery|Eye pressure at postop 3-week is reported|||mmHg at postop 3-week||Standard Deviation|Mean
2750912|NCT00869141|Primary|Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma|Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week|within 6 months after surgery||||participants|||Number
2750913|NCT00869128|Primary|Sleep Efficiency|Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period|3 weeks|ITT|||Percentage of time asleep||Standard Deviation|Mean
2750914|NCT00869089|Primary|Improvement in Prurigo Nodularis||24 weeks|Subjects who completed the study were analyzed.|||participants|||Number
2750915|NCT00869050|Primary|Number of Participants With Complete Response (CR)|CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.|12 months|28/38 analyzed.|||participants|||Number
2750916|NCT00869050|Primary|Number of Participants With Partial Response (PR)|PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.|12 months|28/38 analyzed.|||participants|||Number
2750917|NCT00869024|Secondary|Histological Assessment|Data collection was insufficient for data analysis. Samples were collected but no histological analysis performed.|24 months|Data collection was insufficient for data analysis. Samples were collected but no histological analysis performed.||||||
2750918|NCT00869024|Secondary|Change in Left Ventricular Dimensions|Change in left ventricular dimensions assessed by ECHO at baseline compared to 10 weeks with LVAD turn-down to 6000 RPMs.|10 weeks||||cm||Standard Deviation|Mean
2750919|NCT00869024|Secondary|Number of Participants Turned Down Without Meeting LVAD Stopping Rules|"LVAD turn-down was completed at 10 weeks. Hemodynamic measurements were taken and reported with nominal LVAD support and then again at peak exercise. LVAD turn-down protocol was followed to ensure safety of patient while turning down their LVAD support. After each turn-down we waited 10 minutes and repeated ECHO, RHC, LVAD parameters, vital signs.~Stopping parameters for turn down:~Significant symptoms (clinician judgement, although low threshold to stop test)~CVP>20 or increase by more than 10 (e.g., 5 to 16)~PCWP>25 or increase by more than 10 (e.g., 11 to 22)~Hypotension~Increase in LVIDd by >1.5 cm~Aortic valve opening minimally (less than 1 in 5 beats, e.g.)~The number of patients that could be turn-down without meeting stopping rules and were able to exercise were reported per group."|10 weeks||||Participants|||Count of Participants
2750920|NCT00869024|Primary|Combined End Points of Death|Number of participants who expired during the study.|24 months||||Participants|||Count of Participants
2750921|NCT00869024|Primary|Improvement in Myocardial Viability by PET/CT Scan|"Change in LAD segments from baseline to 10 weeks. PET scan viability is reported by segment on a scale of 0-4. A score of 0, 1, or 2 are categorized as viable/healthy heart tissue and a score of 3 or 4 are categorized as not viable/scar tissue. No change or better in viability will be reported to determine safety of cell injection. Measurement is reported as number of segment that remained the same or improved were considered safe for stem cell injection."|baseline, 10 weeks||||safe segments|||Number
2750922|NCT00869024|Primary|Safety of Cell Delivery|Safety as measured by the total number of adverse events per group.|24 months||||adverse events|||Number
2750923|NCT00868998|Secondary|Toxicity|Data was not analyzed due to poor accrual.|Prior to day 4 and on day 12|||||||
2750924|NCT00868998|Primary|Response Rate|Data was not analyzed due to poor accrual.|10 weeks|||||||
2750926|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|24 weeks||||units on a scale||Standard Deviation|Mean
2750927|NCT00868959|Primary|Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment|Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)|24 weeks||||participants|||Number
2750928|NCT00868790|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.|||Participants|||Number
2750929|NCT00868790|Primary|Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.|||Participants|||Number
2750930|NCT00868790|Secondary|Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels|Blood samples were obtained from all participants to measure LDL-C levels at Week 0 (Baseline) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit). For each visit, LDL-C was measured over 2 days. The average of duplicate measurements (when available) was used in the analysis.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit|All randomized participants who took at least 1 dose of study treatment and had a valid reading at timepoint.|||percentage change from BL||90% Confidence Interval|Least Squares Mean
2750931|NCT00868790|Secondary|Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels|Two-hour PMG was analyzed in both non-domiciled and domiciled participants. Non-domiciled participants completed a 3-point meal tolerance test (MTT) at Week 0 (Baseline) and Week 4 Visits of Treatment Period 1. Participants completed 12-hr fasting prior to the Week 0 (Baseline) and Week-4 clinic visits. Fasting blood samples were obtained at the beginning of these clinic visits, after which participants consumed a standardized meal (1 nutrition bar and 1 can of nutrition drink), and then completed the MTT, in which plasma glucose was measured at 30 min and 120 min (2 hr) post-meal. The 2-hr PMG data also include data from domiciled participants, based on 2-hr post-morning meal glucose levels in the 24-hr blood glucose sample at the Week 4 and Week 8 Visits. The 2-hour PMG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in 2-hour PMG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit|All randomized participants receiving ≥1 dose of therapy and having MTT measurement either at Week 0 (BL) or end of Treatment Period 1. N=number of participants included in the Longitudinal Data Analysis (LDA) model|||mg/dL||Standard Error|Least Squares Mean
2750932|NCT00868790|Secondary|Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)|Fasting blood samples were obtained during study site visits at Baseline (Week 0 Visit) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit). Participants were counseled to fast (no food or drink except water and non-study medications, as directed) for at least 12 hours prior to all study visits. FPG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in FPG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit|All randomized participants receiving ≥1 dose of therapy and having FPG measurement either at BL or end of Treatment Period. Number of Participants Analyzed=number of participants included in the LDA model.|||mg/dL||Standard Error|Least Squares Mean
2750933|NCT00868790|Primary|Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)|The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit|All randomized domiciled participants receiving ≥1 dose of therapy and having 24-hour WMG measurement either at BL or end of Treatment Period 1 or 2. Number of Participants Analyzed=number of participants included in LDA model. Participants in MK-3577 25 mg BID group did not undergo 24-hour glucose sampling and were not analyzed.|||mg/dL||Standard Error|Least Squares Mean
2751015|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
2750934|NCT00868751|Secondary|Measurement of Sustained Clinical Response to Tocilizumab, Including Active Joint Count, Joints With Limited Range of Motion, and Absence of Fever or Rash.|To assess sustained clinical response to tocilizumab, including active joint count, joints with limited range of motion, and absence of fever|At weeks 8, 12, 16 of treatment, and every 8 weeks thereafter|No data are available because data were not collected||||||
2750935|NCT00868751|Secondary|Measurement of Laboratory Parameters of Active Disease, Specifically C-reactive Protein, Hemoglobin, Platelets, White Blood Cell Count, Ferritin, Immunoglobulins.|To assess normalization of laboratory parameters of active disease, specifically C-reactive protein, hemoglobin, platelets, white blood cell|At weeks 8, 12, and 16 of treatment, and every 8-12 weeks thereafter|No data are available because data were not collected||||||
2750936|NCT00868751|Primary|Number of Participants With at Least One Adverse Event|To evaluate the safety of tocilizumab administration in this subject|Ongoing, throughout 24 month study period|No data are available because data were not collected|||Participants|||Count of Participants
2750937|NCT00868751|Primary|Efficacy of Tocilizumab as Defined by Reduction of Oral Prednisone Dose by at Least 20%, or to Less Than 0.5mg/kg/Day, Whichever is of Lesser Daily Dose, While Maintaining an ACR JIA30 Response||At weeks 12 and 16 of treatment versus week 0 (pretreatment)|No data are available because data were not collected||||||
2750938|NCT00868751|Primary|Efficacy of Tocilizumab as Defined by Presence of an Equal to or Greater Than 30% Improvement in JIA Core Set (i.e. ACR JIA30 Response)||At week 12 of treatment versus week 0 (pretreatment)|No data are available because data were not collected||||||
2750939|NCT00868712|Secondary|International Normalized Ratio|The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.||||ratio||Standard Deviation|Mean
2750940|NCT00868712|Primary|Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score|The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; >1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.|After interim analysis following n=70 showed no effect, further enrollment was halted.|||Agatston Score||Standard Deviation|Mean
2750941|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.~The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items."|Baseline to Week 6|Intent-to-treat population is analyzed. Number of participants in table is not consistent with intent-to-treat population because: if one or more items are missing at a study visit, as can occur when a subject opts out of the work/school item because it does not apply, the authors of the scale recommend setting the total score to missing|||units on a scale||Standard Error|Least Squares Mean
2750942|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.~The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome."|Baseline to Week 6|Intent-to-treat population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
2750943|NCT00868699|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items."|Baseline to Week 6|Intent-to-treat population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
2750944|NCT00868608|Secondary|Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.|Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.|Safety Population|||Percentage of Participants|||Number
2751016|NCT00868192|Post-Hoc|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
2750945|NCT00868608|Secondary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.|Protocol reporting period: from informed consent to at least 28 days after the last dose.|Safety Population - includes all participants who received at least 1 dose of study medication. This population only excluded participants who never received any study medication.|||Percentage of Participants|||Number
2750946|NCT00868608|Secondary|Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)|Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL|Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit|There were 80 participants in the analysis dataset, but time-matched PK-ECG data only existed for 73 participants (35 female).|||Milliseconds (msec)||90% Confidence Interval|Median
2750947|NCT00868608|Secondary|Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|6, 12 and 24 months|ITT population (participants with NHL type defined as follicular).|||Probability||95% Confidence Interval|Number
2750948|NCT00868608|Secondary|Kaplan-Meier Estimate of the OS in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Months||95% Confidence Interval|Median
2750949|NCT00868608|Secondary|Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|6, 12 and 24 months|ITT population.|||Probability||95% Confidence Interval|Number
2750950|NCT00868608|Secondary|Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.|||Months||95% Confidence Interval|Median
2750951|NCT00868608|Secondary|Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|ITT population (participants with NHL type defined as follicular).|||Percenr probability||95% Confidence Interval|Number
2750952|NCT00868608|Secondary|Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Months||95% Confidence Interval|Median
2750953|NCT00868608|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|ITT population.|||Percent Probability||95% Confidence Interval|Number
2751017|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|12 months||||percentage of participants||95% Confidence Interval|Number
2750954|NCT00868608|Secondary|Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.|||Months||95% Confidence Interval|Median
2750955|NCT00868608|Secondary|Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|Participants with Follicular NHL who responded.|||Probability||95% Confidence Interval|Number
2750956|NCT00868608|Secondary|Duration of Response in Participants With Follicular NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Participants with Follicular NHL who responded.|||Months||95% Confidence Interval|Median
2750957|NCT00868608|Secondary|Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|Participants with Indolent NHL who responded.|||Probability||95% Confidence Interval|Number
2750958|NCT00868608|Secondary|Duration of Response in Participants With Indolent NHL|Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Participants with Indolent NHL who responded.|||Months||95% Confidence Interval|Median
2750959|NCT00868608|Secondary|Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Percentage of Participants||95% Confidence Interval|Number
2750971|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|8 hours post infusion|The Full Analysis Set (FAS) consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
2750960|NCT00868608|Secondary|Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.|||Percentage of Participants||95% Confidence Interval|Number
2750961|NCT00868608|Secondary|Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Percentage of Participants||95% Confidence Interval|Number
2750962|NCT00868608|Primary|Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Intent to treat (ITT) population: all participants who were enrolled into the study.|||Percentage of Participants||95% Confidence Interval|Number
2750963|NCT00868530|Other Pre-specified|Average Dose of Xyntha Infusions Required Per Hemorrhage|The average dose of Xyntha per hemorrhagic event was calculated as total dose of Xyntha throughout the study (in IU) divided by total number of hemorrhage incidence.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Dose/Bleed (IU)||Standard Deviation|Mean
2750964|NCT00868530|Other Pre-specified|Frequency of Xyntha Infusions Required Per Hemorrhage|The mean frequency of Xyntha infusions per hemorrhage was calculated as total number of injections throughout the study divided by total number of hemorrhagic events.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Infusions||Standard Deviation|Mean
2750965|NCT00868530|Secondary|Number of Participants With Thrombosis||Baseline up to 6 months|The SS consisted of all participants who had taken at least 1 dose of investigational drug.|||Participants|||Number
2750966|NCT00868530|Secondary|Number of Participants With Thrombosis Allergic-Type Reactions||Baseline up to 6 months|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.|||Participants|||Number
2750967|NCT00868530|Secondary|Number of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE, defined for on-demand treatment as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|24 hours after each of 2 successive infusion, up to 6 months|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Participants|||Number
2750968|NCT00868530|Secondary|FVIII Recovery : Change From Baseline in FVIII Concentration|FVIII recovery was assessed by evaluating the change in FVIII concentration at 6 months compared to baseline.|Day 1 and Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. Participants with missing data were not included.|||IU/dL per IU/kg||Standard Deviation|Mean
2750969|NCT00868530|Primary|Number of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and <= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Day 1 and Month 6 or Early Termination Visit|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.|||Participants|||Number
2750970|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|24 hours post infusion|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
2750976|NCT00868517|Secondary|Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps|Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months||||minutes||95% Confidence Interval|Mean
2750977|NCT00868517|Primary|Perceived Sleep Quality|"Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings.~ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia.~The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality."|t=2 months||||units on a scale||95% Confidence Interval|Mean
2750978|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baselin Week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Deviation|Least Squares Mean
2750979|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline Week 6|Full analyis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
2750980|NCT00868452|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline, Week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
2750981|NCT00868439|Secondary|Time to First Elevated Serum K+ > 5.5 mEq/L.||28 Days||||days||95% Confidence Interval|Median
2750982|NCT00868439|Secondary|Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L||Baseline and Day 28|Analysis was determined using LOCF.|||percentage of participants|||Number
2750983|NCT00868439|Secondary|Proportion of Participants Whose Spironolactone Dose Was Increased.||28 Days||||percentage of participants|||Number
2750984|NCT00868439|Secondary|Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).|Analysis based on local laboratory data.|28 Days||||percentage of participants|||Number
2750985|NCT00868439|Secondary|Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.|Analysis based on central laboratory data.|28 Days||||percentage of participants|||Number
2750986|NCT00868439|Primary|Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.||Baseline and Day 28|Analysis was determined using Last Observation Carried Forward (LOCF).|||mEq/L||Standard Error|Least Squares Mean
2750987|NCT00868374|Primary|Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)|The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.|Week 0 - Week 8||||units on a scale||95% Confidence Interval|Mean
2750988|NCT00868348|Secondary|Pain Intensity During Daily Activity|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|16 weeks after surgery||||mm||Inter-Quartile Range|Median
2750989|NCT00868348|Secondary|Length of Hospital Stay||From the day of surgery until discharge||||days||Inter-Quartile Range|Median
2750990|NCT00868348|Secondary|Home Readiness|Ability to meet discharge criteria (home readiness)|time to fulfilment of discharge criteria||||days||Inter-Quartile Range|Median
2750991|NCT00868348|Secondary|Pain Intensity Scores During Walking|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|6-24 hours postoperatively||||mm||Inter-Quartile Range|Median
2750992|NCT00868348|Secondary|Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request||within 48 hours after surgery||||min||Inter-Quartile Range|Median
2750993|NCT00868348|Primary|Morphine Consumption|Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery|48 hours after surgery||||mg||Inter-Quartile Range|Median
2750994|NCT00868309|Secondary|>50,000 Platelets/mm3|Thrombocytopenia during follow up period. Two weeks|Follow up after maintenance dose||||participants|||Number
2750995|NCT00868309|Primary|Detection of Plasma Venom Levels During the Post Acute Treatment Period.||Follow up after Maintenance doses were completed. Two Weeks.||||participants|||Number
2750996|NCT00868296|Primary|Growth Parameters Z-scores|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|6 weeks|Safety population (all patients with ≥1 dose of study drug) who also had baseline and end of study evaluations. Data point pairs were analyzed. All patients in study 3001B3-335 originated from study 3001B3-331 or -333 and baselines from the original study they were in were used.|||units on scale||Standard Deviation|Mean
2751497|NCT00864708|Primary|Walking Endurance (6MWT)|The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.|Day 1 and at 3 months, following treatment||||feet|||Number
2750997|NCT00868296|Primary|Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period|Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.|6 weeks|Patients who received ≥1 dose of pantoprazole and had laboratory test results. The number of patients (n) tested varied by test, variations shown (low dose, high dose): Carbon dioxide (n=7,26), CPK (n=12,42), Gastrin (n=9,25), Neutrophils (n=12,44), Platelet count (n=12,41), Urine protein albumin (n=10,38), Urine leukocyte esterase (n=10,38).|||patients|||Number
2750998|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2750999|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751000|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751001|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751002|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751003|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751004|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751005|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751006|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751007|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751008|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751009|NCT00868231|Primary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment.||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
2751010|NCT00868218|Secondary|Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine|Number of participants with haemagglutination inhibition tigers >= 32 at the long term time point (1 year post vaccination).|one year||||participants|||Number
2751011|NCT00868218|Primary|Adverse Events||42 days||||participants|||Number
2751012|NCT00868218|Primary|Solicted Adverse Events|The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.|three months||||participants|||Number
2751013|NCT00868192|Post-Hoc|CA-125 Response|A CA-125 response was defined as at least a 50% reduction in CA-125 levels from a pretreatment sample following guidelines described by the Gynecological Cancer Intergroup.|6 months|7 participants were not evauable by CA-125 criteria.|||participants|||Number
2751014|NCT00868192|Post-Hoc|Overall Response Rate|"Overall response rate = complete response + partial response~Complete response = disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial response = at least a 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be non unequivocal progression of non-target lesions and no new lesions."|6 months||||percentage of participants||95% Confidence Interval|Number
2751018|NCT00868192|Secondary|Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.||||||
2751019|NCT00868192|Secondary|Gene Expression as Assessed by Illumina cDNA Mediated Annealing, Selection, Extension and Ligation (DASL) Microarray From Paraffin-embedded Tumor Specimens With Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.||||||
2751020|NCT00868192|Secondary|Frequency of Clinical Response|As measured by RECIST criteria|6 months||||participants|||Number
2751021|NCT00868192|Secondary|Toxicity Associated With Bevacizumab and Pemetrexed|Detailed serious adverse events and other adverse events are shown in the adverse event module of the results.|6 months||||percentage of participants|||Number
2751022|NCT00868192|Secondary|Distribution of Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
2751023|NCT00868192|Secondary|Distribution of Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
2751024|NCT00868192|Primary|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|6 months||||percentage of participants||95% Confidence Interval|Number
2751025|NCT00868166|Secondary|The Single-Item Mc Gill Quality of Life Scale|"The single-item McGill quality of life scale evaluated the following question Considering all parts of my life - physical, emotional, social, spiritual, and financial - over the past two (2) days, the quality of my life has been…as a score of 1 to 10 on a visual analog scale where 0 is very bad and 10 is excellent."|Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18|ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.|||score on a scale||Standard Deviation|Mean
2751026|NCT00868166|Secondary|Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups|MMT score involved the examination of 30 items. These 30 items are scored from 0 (no trace of contraction) to 5 (normal power at first try). The global score is the sum of the item scores and can range from 0 to 150. Higher score indicates some power.|Inclusion, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18|ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.|||score on a scale||Standard Deviation|Mean
2751027|NCT00868166|Secondary|Percentage of Participants With SVC Percent Predicted <70% or Had Died Over 18 Months||Month 18 (548 days)|ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for specified analysis.|||percentage of participants||95% Confidence Interval|Number
2751028|NCT00868166|Secondary|Slow Vital Capacity (SVC) Percent Predicted|SVC as a percent of the predicted value was evaluated and reported.|Baseline, Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18|ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated at specified time points.|||percentage (%)||Standard Deviation|Mean
2751029|NCT00868166|Secondary|Percentage of Participants With a Global ALS FRS-R Score of <30 or Death|Percentage of participants with a global ALS FRS-R score of < 30 or death was estimated using the Kaplan-Meier method in the ITT, with a two-tailed log-rank, both stratified by site of onset (bulbar or spinal) and non-stratified. The ALSFRS-R is an ordinal rating scale (0 through 4) used to determine the ALS participant's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).|Month 18 (548 days)|ITT population included all randomized participants irrespective of study medication administration and eligibility status.|||percentage of participants||95% Confidence Interval|Number
2751030|NCT00868166|Secondary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)|The ALSFRS-R is an ordinal rating scale (0 through 4) used to determine the ALS participant's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).|Inclusion, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18|ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.|||score on a scale||Standard Deviation|Mean
2751031|NCT00868166|Secondary|Percentage of Participants With Failure Over 18 Months|Time to failure was defined as the time from randomization to the time of the first event to consider (Tracheostomy, invasive ventilation [IV] or non invasive ventilation [NIV])|From randomization to the time of the first event to consider at 18 months (548 days)|ITT population included all randomized participants irrespective of study medication administration and eligibility status.|||percentage of participants||95% Confidence Interval|Number
2751047|NCT00867932|Primary|Peak And Trough Concentrations Of Eculizumab In Serum At Week 12|Serum concentrations of eculizumab were measured by using a validated enzyme-linked immunosorbent assay (ELISA) method developed at Alexion Pharmaceuticals Bioanalytical Laboratory. The range of the analytical assay was 10 to 600 microgram per milliliter (μg/mL). Peak concentrations were not measured at the early termination (ET) visit.|Pre-infusion and 1 hour post-infusion at End of Treatment (EOT) (Day 84 [Week 12]) or ET|ITT Population: Participants who received at least 1 dose of study drug.|||μg/mL||Full Range|Median
2751032|NCT00868166|Primary|Overall Survival Rate at 18 Months|Overall survival was defined from the date of randomization until the date of death (event) or last known alive date (censored). If the death date was after 18 months, the participant was censored at 18 months (548 days). Participants still alive at or after 18 months were censored at 18 months/ 548 days. All data over the 18-month follow-up period after randomization, and participant survival status at the 18-month follow-up visit for participants who withdrew prematurely from the study for reasons other than death were included.|From the date of randomization until the date of death or last follow-up censored at 18 months (548 days)|ITT population included all randomized participants irrespective of study medication administration and eligibility status.|||percentage of partcipants||95% Confidence Interval|Number
2751033|NCT00868140|Secondary|Matsuda Index|Whole body insulin sensitivity as determined by the Matsuda Index|6 months||||units on a scale||Standard Error|Mean
2751034|NCT00868140|Primary|Fasting Serum Insulin (uIU/ml)|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo|6 months||||uIU.min/ml||Standard Error|Mean
2751035|NCT00868140|Primary|Fasting Serum Insulin|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo|baseline||||uIU.min/ml||Standard Error|Mean
2751036|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|6 months||||% bioactivity at time 0 of OGTT||Standard Error|Mean
2751037|NCT00868140|Secondary|Matsuda Index|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula:~10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load.~Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance."|Baseline||||units on a scale||Standard Error|Mean
2751038|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|Baseline||||% bioactivity at time 0 of OGTT||Standard Error|Mean
2751039|NCT00868101|Secondary|Troponin I|Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.|24 hours||||pg/mL||Standard Deviation|Mean
2751040|NCT00868101|Primary|Interleucine 8|Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method|24 hours||||pg/mL||Standard Deviation|Mean
2751041|NCT00868101|Primary|IkB-alpha Expression|"Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in arbitraries units, that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value."|24 hours||||units on a scale||Standard Deviation|Mean
2751042|NCT00868101|Secondary|NT-proBNP|Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.|24 hours||||pg/mL||Standard Deviation|Mean
2751043|NCT00867932|Secondary|Change From Baseline In LDH Levels|Levels of LDH were determined by using standard laboratory assays. LDH values and the change of LDH from baseline were summarized by visit.|Baseline, Weeks 1 to 12 or ET|ITT Population: Participants who received at least 1 dose of study drug.|||U/L||Standard Deviation|Mean
2751044|NCT00867932|Secondary|Concentration Of Plasma-free Hemoglobin At Baseline And Week 12|Plasma-free hemoglobin was determined for each participant by using standard laboratory assays. The values of plasma-free hemoglobin were summarized by visit.|Baseline, EOT (Day 84 [Week 12]) or ET|ITT Population: Participants who received at least 1 dose of study drug.|||mg per deciliter (mg/dL)||Standard Deviation|Mean
2751045|NCT00867932|Secondary|Area Under The Curve (AUC) Of The Change From Baseline To Week 12 In Levels Of Lactate Dehydrogenase (LDH)|The AUC of LDH was calculated by using the change of LDH from baseline values for each participant up to Week 12. For those participants with missing LDH values, the last observation carried forward method (LOCF) was used to impute missing values. Individual AUC values of LDH were summarized and tabulated.|Baseline, EOT (Day 84 [Week 12]) or ET|ITT Population: Participants who received at least 1 dose of study drug.|||Units * Days per Liter (U*Day/L)||Standard Deviation|Mean
2751046|NCT00867932|Secondary|Number Of Participants With Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) not present prior to exposure to eculizumab or any event already present that worsened in either intensity or frequency following exposure to eculizumab. A serious TEAE was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. Related TEAEs were considered by investigators to be definitely, probably, or possibly related to administration of the study drug. Relationship is ordered as follows: unrelated, possibly related, probably related, or definitely related. TEAEs and TEAE severity were classified in accordance with the Medical Dictionary for Regulatory Activities (MedDRA) 13.0 dictionary. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|First dose of study drug (Day 0) to End of Follow-up (Week 20 [8 weeks after EOT])|ITT Population: Participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2751048|NCT00867815|Secondary|Number of Participants With Any Adverse Events Reported at Visit 2|An adverse event is any untoward medical occurrence in a subject or clinical investigation subject and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally occurring during the trial.|From informed consent signed up to Visit 2 (Day 90+/-30)||||Participants|||Count of Participants
2751049|NCT00867815|Secondary|Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1|The safety population includes participants who signed informed consent and who had any of the following collected at Visit 1 for safety: laboratory values, physical exam, any eye exams, or adverse events.|Day 1||||Participants|||Count of Participants
2751050|NCT00867815|Primary|Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.|Up to 45 days prior to study enrollment||||Participants|||Count of Participants
2751051|NCT00867659|Primary|Ovarian Volumes as a Predictor of OHSS Severity|ultrasound measurements of both ovaries|30 days||||cc||Full Range|Mean
2751052|NCT00867659|Primary|Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS|evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.|4 weeks||||cc (volume of ascites)||Full Range|Mean
2751053|NCT00867568|Secondary|AUC of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose|||ng*hr/mL||Standard Error|Mean
2751054|NCT00867568|Secondary|Cmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose|||ng/ml||Standard Error|Mean
2751055|NCT00867568|Secondary|Progression Free Survival (PFS) of Participants Using Days From Start of Study Drug Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 4 years|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.|||months||Full Range|Mean
2751056|NCT00867568|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.|||participants|||Number
2751057|NCT00867568|Secondary|Tmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose|||hour||Full Range|Mean
2751058|NCT00867568|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of TPI 287 as a single agent and collect exploratory data on the safety and tolerability of TPI 287 in combination with temozolomide (TMZ) in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma|2 years||||participants|||Number
2751059|NCT00867529|Secondary|Time to Engraftment|Median time from transplant to engraftment.|18 Months||||Days||Full Range|Median
2751060|NCT00867529|Secondary|Rate of Graft Rejection and Graft Failure|Number of patients experiencing graft rejection and/or graft failure|18 Months||||Participants|||Count of Participants
2751061|NCT00867529|Secondary|Overall Survival and Progression-free Survival|Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant.|At 6 months and then every year thereafter, up to 18 months||||Participants|||Count of Participants
2751062|NCT00867529|Secondary|Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0|"Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Through day +100 after transplant||||Participants|||Count of Participants
2751063|NCT00867529|Primary|Disease Relapse Rate|Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.|At 18 months||||Participants|||Count of Participants
2751064|NCT00867503|Primary|Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.||Life of study||||Days||Full Range|Median
2751065|NCT00867503|Secondary|Toxicities of Patients Treated With Bendamustine.|Grade 4 Toxicity|Life of the study||||Partcipants|||Number
2751066|NCT00867503|Primary|Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria|life of the study||||Days||Full Range|Median
2751067|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||Percentage of patients|||Number
2751498|NCT00864682|Secondary|Satisfaction With Anesthetic Technique|Were you satisfied with the anesthetic technique? Yes/No|Prior to discharge. One time assessment||||Participants|||Number
2751068|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||Percentage of patients|||Number
2751069|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||BPM (beats per minute)||95% Confidence Interval|Mean
2751070|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||mmHg||95% Confidence Interval|Mean
2751071|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||mmHg||95% Confidence Interval|Mean
2751072|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||mmHg||95% Confidence Interval|Mean
2751073|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of patients|||Number
2751074|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of patients|||Number
2751075|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||BPM (beats per minute)||95% Confidence Interval|Mean
2751076|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
2751077|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
2751078|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
2751079|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 35||||units on a scale||Standard Deviation|Mean
2751080|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2751081|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2751082|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2751083|NCT00867451|Primary|Percent Total Sleep|Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.|Baseline, Week 5||||percentage of immobility||Standard Deviation|Mean
2751084|NCT00867451|Primary|Length of Awake Time|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.|Baseline; Week 5||||minutes||Standard Deviation|Mean
2751085|NCT00867451|Primary|Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.|Baseline; Week 5||||minutes||Standard Deviation|Mean
2751086|NCT00867451|Primary|Sleep Duration|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.|Baseline; Week 5||||minutes||Standard Deviation|Mean
2751087|NCT00867360|Secondary|% Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo|"Time 1 (baseline) = Difference in cortisol level from Day 1 (pre-florinef mean evening cortisol) at Baseline less Day 2 (post-florinef mean evening cortisol) at baseline~Time 2 (post- mife or placebo treatment) = Difference in cortisol level from Day 22 (pre-florinef mean evening cortisol) and Day 23 (post-florinef mean evening cortisol level).~All measurements were the percent change in mean cortisol level from 6 pm to 10 pm. Cortisol levels are expressed as ug/dL~Percent change in cortisol decrease between Time 2 and Time 1 post florinef should be greater with mifepristone than placebo, reflecting enhanced mineralocorticoid receptor activity."|Day 23||||percentage change||Standard Deviation|Mean
2751088|NCT00867360|Primary|Change in Mean Cortisol Level|The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL|Day 1 to Day 9 difference|Change in cortisol from Day 1 to Day 9|||ug/dL||Standard Deviation|Mean
2751089|NCT00867360|Primary|Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)|"The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms.~For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms.~The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms."|baseline to day 9||||units on a scale||Standard Deviation|Mean
2751090|NCT00867334|Secondary|Number of Participants With Stabilization or Reduction in Tumor Size|Results reported as number of patients with stabilization or reduction in tumor size. Tumor response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) solid tumor response criteria, evaluated by CT.|8 weeks after baseline|CT measurements of metastasis were planned through timepoint 3 (24 weeks). One participant only had data at timepoint 1 (8 weeks), so timepoint 1 was chosen as the post-treatment comparison timepoint for all participants. One subject in the imatinib group and one subject in the panitumumab group withdrew before obtaining 8 week evaluations.|||Participants|||Count of Participants
2751195|NCT00866918|Secondary|Hematologic Remission Rate|Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.|End of consolidation, course 1: up to 5 months|Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.|||Proportion of participants|||Number
2751091|NCT00867334|Primary|Number of Patients With Adverse Events|Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected and recorded.|From consent up until 4 weeks after patient has stopped study participation|"The subject randomized to the Standard of Care Therapy with Panitumumab arm withdrew after randomization, so no data was collected."|||Participants|||Count of Participants
2751092|NCT00867321|Secondary|Tumor Response at 6 Months|Tumor response (at 6 months) is defined as the number of responses (complete or partial response per Section 11) over the number of eligible patients observed for at least 6 months. Tumor response will be evaluated using simple estimates of proportions.|6 months|No patients were analyzed for this endpoint because data was not collected for it||||||
2751093|NCT00867321|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up. Kaplan-Meier survival curves will be used to estimate the distribution of OS.|Up to 3 years post treatment|No patients were analyzed for this endpoint because data was not collected for it||||||
2751094|NCT00867321|Primary|Time to Progression (TTP) (Phase II)|Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Kaplan-Meier survival curves will be used to estimate the distribution of TTP.|From baseline up to 3 years post treatment|6 of 7 patients have had at least one post-baseline assessment of disease and were used for this endpoint.|||years||95% Confidence Interval|Median
2751095|NCT00867321|Primary|Maximum Tolerated Dose (Phase I)|MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here.|From baseline up to 3 years post treatment|All eligible patients were treated and analyzed.|||Participants|||Count of Participants
2751096|NCT00867308|Secondary|Grade 3-4 Toxicity|Number of participants who experienced at least one grade 3-4 non-hematological toxicity by CTCAE 3.0 that was attributed to lenalidomide.|Up to 8 months||||Participants|||Count of Participants
2751097|NCT00867308|Primary|Response Rate|Number of participants with a complete or partial response according to International Working Group 2006 criteria.|15 weeks||||Participants|||Count of Participants
2751098|NCT00867217|Primary|Number of Participants With Worsening of Musculoskeletal Symptoms (MS)|Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.|Change from Baseline to 24 Weeks|Subjects available for analysis included those that had completed the entire study; plus three subjects that had dropped out early specifically because of side effects related to musculoskeletal symptoms (one of the endpoints).|||participants|||Number
2751099|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 12|Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751100|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 8|Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751101|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 4|Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751102|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 2|Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751103|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 12|Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751104|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 8|Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751105|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 4|Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751196|NCT00866918|Primary|Event-free Survival (EFS)|EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.|At 3 years from study entry|Ineligible and inevaluable patients are excluded from analyses of EFS.|||Percentage of participants||95% Confidence Interval|Number
2751106|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 2|Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751107|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 12|Plasma campesterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751108|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 8|Plasma campesterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751109|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 4|Plasma campesterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751110|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 2|Plasma campesterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751111|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 12|Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751112|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 8|Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751113|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 4|Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751114|NCT00867165|Secondary|Percent Change From Baseline in Sitosterol at Week 2|Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751115|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12|Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751116|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4|Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751117|NCT00867165|Secondary|Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12|Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751118|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12|Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751119|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8|Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751120|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4|Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751121|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2|Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751122|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 12|Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751123|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 8|Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751124|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 4|Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751125|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 2|Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751126|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12|Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751127|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 8|Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751128|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 4|Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751129|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 2|Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751130|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 8|Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751131|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 4|Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751132|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 2|Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751133|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 8|Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751134|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 4|Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751135|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 2|Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751136|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 8|Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751197|NCT00866905|Secondary|Disease Free Survival|Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.|36 Months|||||||
2751137|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 4|Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751138|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 2|Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751139|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 8|Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751140|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 4|Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751141|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 2|Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751142|NCT00867165|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 12|Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage change||95% Confidence Interval|Least Squares Mean
2751143|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 12|Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751144|NCT00867165|Secondary|Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751145|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12|Serum Apo B measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percent Change||95% Confidence Interval|Least Squares Mean
2751146|NCT00867165|Secondary|Percentage Change From Baseline in Total Cholesterol (TC) at Week 12|Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study~medication and had a baseline value and at least one valid post-baseline evaluation."|||Percentage Change||95% Confidence Interval|Least Squares Mean
2751147|NCT00867165|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study~medication and had a baseline value and at least one valid post-baseline evaluation."|||Percent Change||95% Confidence Interval|Least Squares Mean
2751148|NCT00867139|Secondary|Pharmacokinetics (AUC0-last) of TCAD|Only 5 patients had partial pharmacokinetic (PK) data available. Plasma concentration of oseltamivir was measured at several time points in one patient receiving neuraminidase inhibitor monotherapy. Plasma concentration of oseltamivir, amantadine, and ribavirin were measured at several time points in four patients receiving TCAD therapy. Area under the time-concentration curve up to the last measured time point (AUC0-last) was calculated from the plasma concentration-time profiles by non-compartmental analysis.|5 days||||ng*hr/mL||Standard Deviation|Mean
2751149|NCT00867139|Secondary|Number of Deaths||58 days||||participants|||Number
2751150|NCT00867139|Secondary|Number of Participants With Intubations||58 days||||participants|||Number
2751151|NCT00867139|Secondary|Number of Participants With ICU Admissions|The number of participants with ICU admissions was evaluated.|baseline and up to 58 days||||participants|||Number
2751152|NCT00867139|Secondary|Days on Supplemental Oxygen||58 days|One open-labeled TCAD patient withdrew on day 5.|||days||Standard Deviation|Mean
2751153|NCT00867139|Secondary|Duration of Hospitalization||from baseline up to 58 days|One open-labeled patient withdrew the study on day 5|||days||Standard Deviation|Mean
2751154|NCT00867139|Secondary|Frequency of Confirmed Pneumonia||58 days||||participants|||Number
2751155|NCT00867139|Secondary|Duration of Symptoms|"Calculated as the number of days (mean) any persistent symptom lasted per patient as listed below.~overall health, short of breath, chills, cough, diarrhea, ear pain, fatigue, fever, headache, hoarseness, muscle ache, phlegm, runny nose, sinus congestion, sneezing, sore throat, watery eyes, wheezing"|from baseline up to 28 days|one open labeled patient withdrew on day 5.|||days||Standard Deviation|Mean
2751156|NCT00867139|Secondary|Number of Participants With Viral Resistance as a Function of Drug Exposure|Viral resistance was assessed within 28 days after drug administration by detecting resistance-conferring mutation genes and compared to the value at baseline.|28 days|One open-labeled patient withdrew on day 5.|||Number of participants|||Number
2751157|NCT00867139|Secondary|Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1||10 days|Participants assessed for viral shedding were those with available baseline viral load data.|||participants|||Number
2751158|NCT00867139|Secondary|Number of Participants With Viral Load Decrease as a Function of Time|Viral loads were measured by quantitative Polymerase Chain Reaction (PCR) on day 1, 3, 5, 7, 9, 15, 20 and 28, if applicable.|baseline and 28 days|Three patients could not get viral load at baseline.|||number of participants|||Number
2751159|NCT00867139|Primary|Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption|"Abnormal lab data or newly appeared symptoms & signs were considered as AEs.~Examined lab data:~Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)"|30 days after the final dose of study drug||||number of participants with AEs|||Number
2751160|NCT00867113|Secondary|Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months|Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.|Baseline up to appoximately 60 months||||percentage of participants||95% Confidence Interval|Number
2751161|NCT00867113|Secondary|Overall Survival (OS) at 60 Months|Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.|Baseline up to approximately 60 months||||participants|||Number
2751162|NCT00867113|Primary|Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months|Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated|Baseline up to 60 months||||percentage of patients||95% Confidence Interval|Number
2751163|NCT00867113|Primary|Recurrence-free Survival up to 60 Months|Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).|Baseline up to 60 months||||participants with an event|||Number
2751164|NCT00867100|Primary|Part A: All Treatment Adverse Events Reported for Safety Evaluation|This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.|Cohort 1-4 43 days, Cohort 5-8 64 days||||participants with events|||Number
2751165|NCT00867100|Primary|Part B: All Treatment Adverse Events Reported for Safety Evaluation|This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.|85 days||||participants with events|||Number
2751166|NCT00867100|Primary|Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43|Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.|Through day 43|This PASI outcome measure data refers only to Part B subjects with moderate to severe plaque psoriasis.|||percentage improvement||Standard Deviation|Mean
2751167|NCT00867087|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment|An AE was any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory/physiologic observations occurring in a participant given a test article or in a clinical study; the event may not necessarily have had a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; cancer. Treatment-emergent AEs were AEs that emerged after the first dose of the study treatment during the treatment period that were absent pre-treatment, or worsened during the treatment period relative to the pre-treatment state. The severity of all AEs was graded by the investigator using the NCI Common Terminology Criteria for AE Version 3.0 (CTCAE v3.0).|Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).|Safety population Summary excludes events occurring after start of consolidation treatment.|||Percentage of Participants|||Number
2751194|NCT00866918|Secondary|Hematologic, Molecular, and Cytogenetic Remission Rate|Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.|End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)|Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.|||Proportion of participants|||Number
2751168|NCT00867087|Secondary|Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy|The following parameters were analyzed for serum chemistry; blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. The following parameters were analyzed for hematology; lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).|Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).|Safety population|||Percentage of Participants|||Number
2751169|NCT00867087|Secondary|Overall Survival (OS)|OS was the time (in months) from the date of randomization to the date of death, and censored at the date of last contact if no death occurred.|From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).|ITT population|||Months||95% Confidence Interval|Median
2751170|NCT00867087|Secondary|Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|CR: complete disappearance of all detectable clinical & radiographic evidence of disease & disease-related symptoms; lymph nodes & nodal masses regressed to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy); spleen and other organs (if enlarged prior to therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. Response includes confirmed CR and unconfirmed CR.|From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2751171|NCT00867087|Secondary|Event-Free Survival (EFS) After aSCT|EFS was the time (in months) from the date of aSCT to the earliest date of progression, relapse after CR, death from any cause without progression, initiation of a new treatment for the lymphoma or was censored at the date of the last tumor assessment.|From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.|ITT population. Only participants who underwent aSCT were included in the analysis.|||Months||95% Confidence Interval|Median
2751172|NCT00867087|Secondary|Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)|Participants underwent high dose chemotherapy and aSCT. In order to proceed to aSCT, participants were required to achieve CR or PR and successful collection of PSBC (≥ 2.0 x 10^6 CD34+ cells/kg collected after 3 cycles).|A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2751173|NCT00867087|Secondary|Percentage of Participants With Successful G-CSF Mobilization of PBSC|Successful mobilization of PBSC was defined as ≥ 2 x 10^6 CD34+ cells/kg collected after 3 cycles of inotuzumab ozogamicin plus rituximab therapy.|From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2751174|NCT00867087|Secondary|Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|Successful mobilization of PBSC: ≥ 2 x 10^6 cluster of differentiation (CD) 34+ cells per kilogram (cells/kg) after 3 cycles. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (≤ 1.5 cm in greatest transverse diameter for nodes > 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: ≥ 50% decrease in SPD of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment post treatment were partial responders. Response includes confirmed CR/PR and unconfirmed CR/PR.|From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2751175|NCT00867087|Secondary|Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy|PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.|2 years after the first dose of inotuzumab ozogamicin|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2751176|NCT00867087|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy|PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.|6 months after the first dose of inotuzumab ozogamicin|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2751198|NCT00866905|Secondary|Overall Survival|Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause.|36 months|||||||
2751177|NCT00867087|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin's lymphoma. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to [≤] 1.5 cm in greatest transverse diameter for nodes greater than [>] 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: > or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.|Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)|Intention-to-treat (ITT) population - included all participants enrolled into the study. Response includes confirmed CR/PR and unconfirmed CR/PR.|||Percentage of Participants||95% Confidence Interval|Number
2751178|NCT00867035|Secondary|Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate||1 week|ITT|||percentage black colonies||Standard Deviation|Mean
2751179|NCT00867035|Secondary|Number of Bacteria on Tongue at 1 Week|Total viable count(TVC) in colony forming units(CFU) on anaerobe agar|1 week|ITT|||colony forming units (CFU)||Standard Deviation|Mean
2751180|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT|||parts per billion||Standard Deviation|Mean
2751181|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT|||parts per billion||Standard Deviation|Mean
2751182|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours|Using portable gas chromatograph|2 hours||||parts per billion||Standard Deviation|Mean
2751183|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour|Using portable gas chromatograph|1 hour|ITT|||parts per billion (ppb)||Standard Deviation|Mean
2751184|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT|||parts per billion (ppb)||Standard Deviation|Mean
2751185|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT|||parts per billion (ppb)||Standard Deviation|Mean
2751186|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours|Using portable gas chromatograph|2hr|ITT|||parts per billion (ppb)||Standard Deviation|Mean
2751187|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour|Using portable gas chromatograph|1hr|ITT|||parts per billion (ppb)||Standard Deviation|Mean
2751188|NCT00867035|Primary|Percentage of Participants With Rosenberg Score at Indicated Time Points|2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.|baseline, 1 hour, 2 hours, 4 hours, 1 week|two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.|||percentage of participants|||Number
2751189|NCT00867009|Secondary|The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.|From start of treatment until documented best tumor response (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||percentage of participants|||Number
2751190|NCT00867009|Secondary|The Percentage of Participants Still Living at One Year (One Year Survival Rate)|The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.|One year|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||percentage of participants|||Number
2751191|NCT00867009|Secondary|Progression-free Survival (PFS)|PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.|From start of treatment until documented disease progression or death from any cause (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||months||Full Range|Median
2751192|NCT00867009|Primary|Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.|From start of treatment until documented best response. (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||percentage of participants|||Number
2751193|NCT00866918|Secondary|Overall Survival (OS)|OS - time from study entry to death.|At 3 years from study entry|Ineligible and inevaluable patients are excluded from analyses of OS.|||Percentage of participants||95% Confidence Interval|Number
2751199|NCT00866905|Secondary|Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain|Non hematologic treatment-related grade 4 toxicities measured according to RECIST v1.1|3 months||||participants|||Number
2751201|NCT00866879|Secondary|Percentage of Regulatory T Cells|"Specifically we reported here the percentage of regulatory T cells that were present in the two groups at 24 months post randomization.~With peripheral leukocytes taken at baseline (first visit) prior to randomization and at 6, 12 and 24 Months post-randomization, researchers will also review possible modifications of lymphocytes function and of the lymphocytes subpopulations that might have occurred as a consequence of the switch from tacrolimus to sirolimus (randomization)."|Assessed at 6 Months, 12 Months, 24 Months, months 24 reported||||% of Treg Cells||Standard Deviation|Mean
2751202|NCT00866879|Secondary|Patient and Graft Survival|This study also reviews the impact of the immunosuppressive medications on patient and graft survival.|Assessed at 6 Months, 12 Months, 24 Months, months 24 reported||||number of incidents|||Number
2751203|NCT00866879|Secondary|Evaluate if CI Conversion Impacts on Lipid Profile, Incidence of Hypertension, Malignancies, and Opportunistic Infections and Post-transplant DM|In addition to monitoring renal allograft function, evaluation will be conducted on the incidence of acute rejection, patient and graft survival, the impact of CI conversion on the lipid profile, the incidence of hypertension, malignancies, opportunistic infections and post-transplant DM (de novo diabetes mellitus).|Assessed at 6 Months, 12 Months, 24 Months, months 24 reported||||number of incidents|||Number
2751204|NCT00866879|Secondary|Renal Allograft Function Calculated With e-GFR and Proteinuria|Evaluate whether CI conversion (tacrolimus→sirolimus) contributes positively or negatively on the renal allograft function calculated with e-GFR and proteinuria|Assessed at 6 Months, 12 Months, 24 Months, months 24 reported||||mL/min||Standard Deviation|Mean
2751205|NCT00866879|Primary|Incidence of Acute Cellular Rejection|The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil/Cellcept ® and either tacrolimus/Prograf ® (Group #1) or mycophenolate mofetil/Cellcept ® and sirolimus/Rapamune® (Group #2) impacts the incidence of acute cellular rejection in post-kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.|Assessed at 6 Months, 12 Months, 24 Months, months 24 reported||||Participants|||Count of Participants
2751206|NCT00866814|Secondary|Procedure Time|Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.|Day of surgery|All enrolled patients.|||minutes||Standard Deviation|Mean
2751207|NCT00866814|Secondary|Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey|"Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure."|Baseline and post-surgery at week 2, month 6 and month 12|All enrolled patients with QOL scores at each visit.|||units on a scale (0-5)||Standard Deviation|Mean
2751208|NCT00866814|Secondary|Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|22 days post surgery through 1 year post surgery|All enrolled patients.|||Complication events|||Number
2751209|NCT00866814|Secondary|Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|Hospital discharge through 21 days post surgery|All enrolled patients.|||Complication events|||Number
2751210|NCT00866814|Secondary|Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|From the time of surgery to hospital discharge, an average of 1-2 days|All enrolled patients.|||Complication events|||Number
2751211|NCT00866814|Primary|The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.|A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.|1 year post surgery|All enrolled patients.|||participants|||Number
2751212|NCT00866788|Secondary|Terminal Half-Life (t1/2) of Omalizumab|Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.|||days||Standard Deviation|Mean
2751213|NCT00866788|Secondary|Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)|AUCinf is the area under the concentration−time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg*day/mL). Only participants having complete profiles and completed the study were included in the analysis.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.|||µg*day/mL||Standard Deviation|Mean
2751214|NCT00866788|Secondary|Time to Maximum Concentration (Tmax) of Omalizumab|Tmax is the time to maximum concentration of omalizumab.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.|||days||Standard Deviation|Mean
2751408|NCT00866047|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 3 years|Participants with complete remission among the intention to treat population|||months||95% Confidence Interval|Median
2751215|NCT00866788|Secondary|Maximum Observed Concentration (Cmax) of Omalizumab|Cmax is the maximum (or peak) concentration of omalizumab in serum.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population included all randomized participants who received omalizumab and had pharmacokinetic data available. Here, number of participants analyzed = participants with available data for this outcome measure.|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
2751216|NCT00866788|Secondary|Number of Participants With Immunogenicity|Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).|16 weeks|Safety-Evaluable Population|||participants|||Number
2751217|NCT00866788|Secondary|Number of Patients With Adverse Events by Severity|"The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities.~Additional AE data is provided in the AE section below. The terms severe and serious are not synonymous. Severity refers to the intensity of an AE. A Serious AE is defined below."|"16 weeks overall (data reported separately for up to 4 weeks and Weeks 5 to 16)"|Safety-Evaluable Population, which included all randomized patients who received any study drug. number (n) equals (=) number of participants analyzed in the specified category.|||participants|||Number
2751218|NCT00866788|Secondary|Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4|Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||Pills||Standard Deviation|Mean
2751219|NCT00866788|Secondary|Change in the Weekly Score for Sleep Interference From Baseline to Week 4|The extent to which hives or itch interfered with participants' sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2751220|NCT00866788|Secondary|Change in the Weekly Score for Number of Hives From Baseline to Week 4|The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2751221|NCT00866788|Secondary|Change in the Weekly Pruritus Score From Baseline to Week 4|The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2751222|NCT00866788|Primary|Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4|The UAS is a composite diary−recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2751223|NCT00866775|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60; Baseline: 60; Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Baseline: 118; Titration: 118; AED taper/conversion: 114; Monotherapy: 93|||Number of seizures in 28 days||Standard Deviation|Mean
2751224|NCT00866775|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population|||Percent of participants|||Number
2751225|NCT00866775|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|18 Week Double-blind treatment period|ITT population|||Percent|||Number
2751226|NCT00866775|Secondary|Percentage of Subjects With Increase of Body Weight >= 7%||18 Week Double-blind treatment period|ITT population|||Percentage of participants|||Number
2752006|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 2|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 2|FAS (LOCF)|||participants|||Number
2751227|NCT00866775|Secondary|Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversation period: 7; Change from baseline to end of monotherapy period: 6 (ESL 1600 mg) Change from baseline to end of AED taper/conversation period: 13; Change from baseline to end of monotherapy period: 13|||units on a scale||Standard Deviation|Mean
2751228|NCT00866775|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period: 41 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 92; Change from baseline to end of monotherapy period: 91|||units on a scale||Standard Deviation|Mean
2751229|NCT00866775|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|the numbers analyzed represent all participants for whom data were available at baseline (ESL 1200 mg)Change from baseline to end of AED taper/conversion period: 39;Change from baseline to end of monotherapy period:36 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 86;Change from baseline to end of monotherapy period: 86|||units on a scale||Standard Deviation|Mean
2751230|NCT00866775|Secondary|Percentage of Subjects Reaching Each of the Exit Events.|The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 1 to Week 18|efficacy population|||percentage of participants|||Number
2751231|NCT00866775|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
2751232|NCT00866775|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60;Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Titration: 118; AED taper/conversion:114; Monotherapy:93|||percent change||Inter-Quartile Range|Median
2751233|NCT00866775|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|efficacy population|||days||95% Confidence Interval|Median
2751234|NCT00866775|Secondary|Completion Rate During the 10 Weeks of Monotherapy|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Weeks 8 through 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
2751235|NCT00866775|Secondary|Completion Rate|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|Week 1 to Week 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
2751236|NCT00866775|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Weeks 15 through 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
2751237|NCT00866775|Secondary|Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Weeks 9 through 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
2751409|NCT00866047|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 3 years|Participants with objective response among the intention to treat population|||months||95% Confidence Interval|Median
2751238|NCT00866775|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 3 to Week 18|efficacy population|||proportion of participants||95% Confidence Interval|Number
2751239|NCT00866749|Secondary|Participants Achieving Negative Minimal Residual Disease (MRD)|To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients.|up to 3 months|Of the 108 participants who achieved a complete response (CR), 60 participants were MRD negative on day 29 and an additional 27 participants were MRD negative on day 84 for a total 87 MRD negative participants on day 84|||participants|||Number
2751240|NCT00866749|Primary|Participants With a Complete Response (CR)|Complete Response defined as: Bone Marrow blasts </= 5%, Platelets >/= 100 and an Absolute Neutrophil Count (ANC) >/= 1000|Up to 1 year||||participants|||Number
2751241|NCT00866749|Primary|Overall Survival|Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 12 years||||Months||Full Range|Median
2751242|NCT00866749|Primary|3-Year Event-Free Survival (EFS)|3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.|3 Years|Of the 108 participants who had a complete response, 68 met the definition for 3 year EFS.|||Participants|||Count of Participants
2751243|NCT00866723|Primary|Clinical Benefit Response Rate|Clinical benefit response was defined as absence of disease progression at 18 weeks (ie after 6 cycles). Disease progression (PD) could occur per RECIST 1.0 or based on CA-125 levels. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Disease progression based on CA-125 level was doubling of the CA-125 level from baseline. For patients with normal baseline CA-125 (who by definition had MD) the criterion for progression based on CA-125 doubling was doubling of CA-125 from the upper limit of normal (i.e. more than 70).|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.|||proportion of particpants||90% Confidence Interval|Number
2751244|NCT00866723|Primary|Clinical Response Rate|For measurable disease (MD) patients, clinical response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For non-MD patients, clinical response based on modified Gynecologic Cancer Intergroup (GCIG) criteria was defined as at least a 50% decrease in CA-125 levels.|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
2751245|NCT00866697|Secondary|Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)|Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants with any TSH above 5 MU/L were analyzed.|||participants|||Number
2751246|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.|||participants|||Number
2751247|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.|||participants|||Number
2751499|NCT00864682|Secondary|Complete Alleviation of Injection Pain|Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)|Immediately after injection of study drug. One time assessment||||Participants|||Number
2751248|NCT00866697|Secondary|Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population|||participants|||Number
2751249|NCT00866697|Secondary|Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25|The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751250|NCT00866697|Secondary|Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25|The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751251|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25|Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).||||||
2751252|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25|Data were not analyzed due to low compliance (<50% at Baseline).||||||
2751253|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751268|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2751254|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751255|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751256|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Mean
2751257|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751258|NCT00866697|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 (poor to excellent). Participants were asked to respond to the following questions using the 7-item Likert scale: How would you rate your overall health during the past week; How would you rate your overall quality of life during the past week? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA)."|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2751259|NCT00866697|Secondary|3-year Progression-free Survival|3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 3 years after randomization|ITT Population|||percentage of participants|||Number
2751269|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2751260|NCT00866697|Secondary|Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria|Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.|From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)|ITT Population. For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment.|||months||95% Confidence Interval|Median
2751261|NCT00866697|Secondary|Overall Survival - Hazard Ratio|Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause up to approximately 95 months|||||||
2751262|NCT00866697|Secondary|Overall Survival - Median|Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause up to approximately 95 months|ITT Population|||months||95% Confidence Interval|Median
2751263|NCT00866697|Primary|Investigator-assessed Progression-free Survival (PFS)|PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.|From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
2751264|NCT00866658|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2751265|NCT00866658|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2751266|NCT00866658|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2751267|NCT00866658|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2751410|NCT00866047|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
2751270|NCT00866658|Secondary|Change From Screening in Total Insulin Dose at Week 24|Change was calculated by subtracting screening value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Screening, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post baseline insulin dose assessment during on-treatment period.|||units per day||Standard Error|Least Squares Mean
2751271|NCT00866658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2751272|NCT00866658|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2751273|NCT00866658|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2751274|NCT00866658|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2751275|NCT00866658|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2751276|NCT00866619|Secondary|Number of Subjects With Fatal Outcomes, by Gender|Mortality was presented as overall mortality (up to Month 20 and up to study end), mortality due to severe malaria as per secondary case definition(SCD), cerebral malaria as per secondary case definition (SCD), meningitis, fatal all-cause traumas and fatal malaria. SCD= Plasmodium falciparum malaria > 5000 parasites/mcL and 1 or more markers of severe malaria (prostration, respiratory distress, Blantyre score ≤ 2, seizures 2 or more, hypoglycemia < 2.2 mmol/L, acidosis BE ≤ -10.0 mmol/L,lactate ≥ 5.0 mmol/L, anemia < 5.0 g/dL.|From Month 0 up to study end (SE - median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751277|NCT00866619|Secondary|Number of Very Low-weight Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.|From Booster (Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)]|The analysis was performed on a subset of subjects from the ITT population, which included very-low weight (VLW) children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751278|NCT00866619|Secondary|Number of Very Low-weight (VLW) Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.|From Month 0 up to Month 20|The analysis was performed on a subset of subjects from the ITT population, which included very-low weight (VLW) children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751279|NCT00866619|Secondary|Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2.|From Booster (Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on a subset of subjects from the ITT population, which included low weight (LW) children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751280|NCT00866619|Secondary|Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2.|From Month 0 up to Month 20|The analysis was performed on the ITT population, which included low weight (LW) children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751281|NCT00866619|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 up to Booster (Month 20), from Month 0 up to study end and from Month 20 up to study end|The analysis was performed on a subset of subjects from the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751282|NCT00866619|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within the 30-day (Days 0-29) post-booster vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751283|NCT00866619|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed, across age categories for which groups were pooled from the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751284|NCT00866619|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Booster (at Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751285|NCT00866619|Secondary|Number of Subjects With Serious Adversee Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 up to Month 20|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751286|NCT00866619|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the 30-day (Days 0-29) post-primary vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751287|NCT00866619|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 up to Month 14|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751288|NCT00866619|Secondary|Number of Subjects With Unsolicited AEs Related to Vaccination in the Low-weight (LW) and Very Low-weight (VLW) Category|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.|Within the 30-day (Days 0-29) post-booster vaccination period|The analysis was performed on a subset of subjects from the ITT population, which included low-weight (LW) and very low-weight (VLW) children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751297|NCT00866619|Secondary|Number of Subjects Reporting Mucocutaneous Changes (All Levels)|Levels of mucocutaneous changes reported were: cutaneous and mucosal change; cutaneous only change; mucosal only change; cutaneous change focused on the nappy/diaper area. Mucocutaneous changes results calculated based on the first 200 subjects in the 6-12 weeks age category in each study center were enrolled, and with available data (i.e. who received a booster dose).|During the 30-day (Days 0-29) post-booster vaccination|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751411|NCT00866047|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
2751289|NCT00866619|Secondary|Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal in the Low-weight (LW) and Very Low-weight (VLW) Category|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center, who were reported with HIV infected status ((HIV status either as per general medical history taken at screening or as identified by morbidity surveillance). Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.|Within the 30-day (Days 0-29) post-primary vaccination period in HIV-infected children|The analysis was performed on the HIV-ITT population, which included low-weight and very low-weight children who received at least one dose of GSK257049 vaccine and were identified as HIV-infected, that is, confirmed to be HIV-infected via identification as positive for HIV by Polymerase Chain Reaction (PCR), or by antibody at 18 months or older.|||Participants|||Count of Participants
2751290|NCT00866619|Secondary|Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center, who were reported with HIV infected status ((HIV status either as per general medical history taken at screening or as identified by morbidity surveillance).|Within the 30-day (Days 0-29) post-primary and post-booster vaccination period in HIV-infected children|The analysis was performed on the HIV-ITT population, which included all children who received at least one dose of GSK257049 vaccine and were identified as HIV-infected, that is, confirmed to be HIV-infected via identification as positive for HIV by Polymerase Chain Reaction (PCR), or by antibody at 18 months or older.|||Participants|||Count of Participants
2751291|NCT00866619|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.|Within the 30-day (days 0-29) post-booster vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751292|NCT00866619|Secondary|Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.|Within the 30-day (Days 0-29) post-primary vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751293|NCT00866619|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.|Within the 30-day (Days 0-29) post-primary vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751294|NCT00866619|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Month 0 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751295|NCT00866619|Secondary|Number of Subjects Reporting Any Meningitis and Encephalitis SAEs|Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis haemophilus; meningitis meningococcal; meningitis tuberculous; encephalomyelitis.|From Booster up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751296|NCT00866619|Secondary|Number of Subjects Reporting Any Meningitis and Encephalitis Serious Adverse Events (SAEs)|Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis/encephalitis viral; meningism; meningitis haemophilus; meningitis meningococcal; meningitis pneumococcal; meningitis tuberculous; encephalomyelitis.|At Month 0 until study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751500|NCT00864682|Primary|Verbal Pain Score|11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain|Immediately after injection of study drug. One time assessment.||||Units on a scale||Inter-Quartile Range|Median
2751298|NCT00866619|Secondary|Number of Doses With Seizures by Diagnostic Certainty Level|Diagnostic certainty levels included: Level 1- Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 2- History of unconsciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 3- History of unconsciousness and other generalized motor manifestations; Level 4- Reported generalized convulsive seizure with insufficient evidence to meet the case definition; Level 5- Not a case of generalized convulsive seizure.|During the 7-day (Days 0-6) post-booster vaccination period, at Month 20 + 7 Day (Days 0-6)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Doses|||Number
2751299|NCT00866619|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751300|NCT00866619|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.|||Participants|||Count of Participants
2751301|NCT00866619|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine and had their symptom sheets filled in.|||Participants|||Count of Participants
2751302|NCT00866619|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine and had their symptom sheets filled in.|||Participants|||Count of Participants
2751303|NCT00866619|Secondary|Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3|Anti-Polio 1, 2 and 3 antibody titers were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was an antibody titer ≥ 1:8.|At Day 0 and at Month 3|The ATP population for Polio Sabin™ immunogenicity included all subjects from the ATP population for immunogenicity (minus those who received ≥ 2 doses of Polio Sabin™ vaccine prior to Dose 1 of study vaccine, or who received at least one dose of a polio vaccine in co-administration with the study vaccine before one month post Dose 3 blood sample.|||Titer||95% Confidence Interval|Geometric Mean
2751304|NCT00866619|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)|Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 6.2 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.|At Months 20 and 21|The analysis was performed on the ATP population for HBs immunogenicity post booster, which included the first 200 children enrolled in Korogwe, Lamberene and Lilongwe study centers in each age category who received the booster dose of GSK257049 vaccine and all vaccinations according to the protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751305|NCT00866619|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen|Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.|At Day 0 and at Month 3|The analysis was performed on the HIV-ATP population for immunogenicity, which included all children included in the HIV-ITT population who received all vaccinations according to the protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751306|NCT00866619|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)|Antibody concentrations assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.|At Day 0 and at Month 3|The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center, for each age category who received all vaccinations according to the protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751373|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Baseline to Day 85|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
2751307|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post booster vaccination pooled across sites, on subjects in R3R (5-17M; 6-12W) (or R3R below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.|From Booster at Month 20 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751308|NCT00866619|Secondary|Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile|Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.|At Month 21|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2751309|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post primary vaccination pooled across sites, on subjects in GSK257049-Menjugate Groups (5-17M; 6-12W) and Comparator Groups (5-17M; 6-12W), taking into account the first 200 participants per site.|From Month 2.5 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751310|NCT00866619|Secondary|Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile|Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.|At Month 3|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2751311|NCT00866619|Secondary|Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)|Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results for this endpoint were assessed for Agogo, Lilongwe and Siaya sites.|At Month 44 and at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures. Data was not collected for the participants in the 6-12W groups at M44.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2751312|NCT00866619|Secondary|Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)|Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL.|At Months 20, 21 and 32|The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures. Data was not collected for the participants in the 5-17M groups for the Manhica site at any given time frame.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2751313|NCT00866619|Secondary|Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)|Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.|At Day 0 and at Month 3|The analysis was performed on the HIV-ATP population for immunogenicity, which included all children included in the HIV-ITT population who received all vaccinations according to the protocol procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2751314|NCT00866619|Secondary|Antibody Concentrations Against Plasmodium Falciparum Circumsporozoite (Anti-CS)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 subjects enrolled in each study center.|At Day 0 and at Month 3|The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2751403|NCT00866047|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
2751315|NCT00866619|Secondary|Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ)|Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children. Note: The early study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end and to late study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end.|At Months 32, 44, at study end (early and late) (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine. Data was not collected for the participants in the 6-12W groups for the HAZ, WAZ, MUACZ categories at Month 44 and at Study end Late time frames.|||z-score||Standard Deviation|Mean
2751316|NCT00866619|Secondary|Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ)|Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children.|At Month 20 (Booster)|The analysis was performed on the Intent-to-Treat (ITT) population, which included all children who received at least one dose of study vaccine.|||z-score||Standard Deviation|Mean
2751317|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). Analysis was performed on subjects aged 5-17 months and 6-12 weeks at enrollment. Results were presented by gender and overall.|From Month 2.5 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751318|NCT00866619|Secondary|Percentage of Subjects With Blood Transfusion, as Per Case Definition Assessed|Blood transfusion case definition assessed was the case definition 1 (CD1). Blood transfusion of CD1 was defined as a child with inpatient admission with documented blood transfusion.|From Month 2.5 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751319|NCT00866619|Secondary|Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed|Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea (>= 50 breaths per minute < 1 year, >= 40 breaths per minute >= 1year) AND lower chest wall indrawing,SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission,SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission,SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%.All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excluding planned admissions for medical investigation/care or elective surgery and trauma).All-cause mortality of CD1 was defined as a fatality (of any cause),of CD2 defined as a fatality (medical cause).Sepsis of CD1 was defined as a child with positive blood culture;CD2 defined as a child with positive salmonella blood culture.|From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751320|NCT00866619|Secondary|Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed|Fatal malaria case definitions assessed were PCD and SCD1. Fatal malaria of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease (defined in a previous outcome measure) with a fatal outcome. Fatal malaria of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease (defined previously) with a fatal outcome. All-cause mortality case definitions assessed were the case definitions (CD) 1 and 2. All-cause mortality of CD1 was defined as a fatality (of any cause) (including mortality in the community and in hospital). All-cause mortality of CD2 was defined as a fatality (medical cause) (including mortality in the community and in hospital), at the exclusion of trauma which may be diagnosed by verbal autopsy. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.|From Month 2.5 to Month 20|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751404|NCT00866047|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
2751321|NCT00866619|Secondary|Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed|Pneumonia case definitions assessed are PCD and SCD 1, 2 and 3. Pneumonia of PCD was defined as cough or difficulty breathing AND tachypnea (≥ 50 breaths per minute < 1 year, ≥ 40 breaths per minute ≥ 1year) AND lower chest wall indrawing. Pneumonia of SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission. Pneumonia of SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission. Pneumonia of SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation < 90%. All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excludes planned admissions for medical investigation/care or elective surgery and trauma). Sepsis cases were defined as a child with positive blood culture (CD1) or salmonella blood culture (CD2).|From Month 2.5 to Month 20|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751322|NCT00866619|Secondary|Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia|Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at timing of assessment. Analysis was performed on subjects aged 5-17 months at enrollment. Study End (Early) corresponds to children whose Month 32 visit took place after 30 June 2012 and who had one cross-sectional visit at study end. These children's last study visit was relatively earlier, with a median follow-up time of 14 months post Month 32. Study End (Late) corresponds to children whose Month 32 visit took place before (and including) 30 June 2012, and who had 2 cross-sectional visits after Month 32. These children's last study visit was relatively later, with a median follow-up time of 17 months post Month 32).|At Months 32, 44, at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category) (early and late)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period 14 days post Dose 3. Data was not collected for the participants in the 6-12W groups for the PP, PSA, PMA categories at M44, SE (Late).|||Percentage of subjects|||Number
2751323|NCT00866619|Secondary|Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia|Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent gametocytemia (PG) was defined as a documented P. falciparum gametocyte density > 0 identified at a cross sectional survey. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at at timing of assessment. Results presented are uncorrected for the double enrollment of one subject receiving RTS,S/AS01.|At Month 20 (Booster)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 6-12W groups for the PG category.|||Percentage of subjects|||Number
2751324|NCT00866619|Secondary|Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered|ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.|From Month 2.5 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751325|NCT00866619|Secondary|Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered|ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.|From Month 2.5 to up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751412|NCT00866034|Other Pre-specified|Endocrine Profile in the Early, Mid and Late Follicular Phase.|"difference in endocrine profile between the 2 arms during the mid and late follicular phase~influence of early elevated follicular phase progesterone levels on clinical outcome"|2 years|||||||
2751413|NCT00866034|Secondary|Cumulative Ongoing Pregnancy Rate||2 years||||cumulative ongoing pregnancy rate (%)|||Number
2751326|NCT00866619|Secondary|Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered|CD considered were CD1 for ISA and CD1 and CD2 for MH. ISA of CD1 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 5000 parasites/μL. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum > 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.|From Month 2.5 to Month 20|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751327|NCT00866619|Secondary|Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1|SPFMI of PCD = PFMI >5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL.|From Month 2.5, from Month 20(booster), from Month 33 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17M age category and of 38 months post-Dose 1 for 6-12W age category) and from Month 2.5 to Month 32 and from Month 20 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751328|NCT00866619|Secondary|Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1|SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.|From Month 2.5 to Month 20 at Booster|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751329|NCT00866619|Secondary|Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1|SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.|From Month 2.5 to Month 14|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751330|NCT00866619|Secondary|Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers|SPFMI of PCD = PFMI > 5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI >0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI >5000 parasites/μL, with one or more severity marker, and without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia < 2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l < 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. Analysis was performed in a pooled manner across age categories. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.|From Month 2.5 up to the time when 250 subjects were diagnosed with severe malaria of PCD, SCD1, SCD2 and SCD3 (up to the Month 14 time point for each age category or date of booster dose, whichever occurred first)|The analysis was performed, across age categories for which groups were pooled from the ATP population for efficacy. This included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||Percentage of subjects|||Number
2751414|NCT00866034|Primary|Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.||2 years||||Cumulative live birth rate (%)|||Number
2751501|NCT00864539|Primary|Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group|Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.|10 weeks||||nmol/L||Standard Deviation|Mean
2751331|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).|From Booster at Month 20 up to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751332|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1)|CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).|From Month 2.5 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751333|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.|From Month 2.5 to Month 32|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.|||events per person-year|||Number
2751334|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD and SCD1, Across Centers|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.|From Month 33 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751335|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), Across Centers|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.|From Booster at Month 20 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751336|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1), Across Centers|CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.|From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751337|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers|CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.|From Month 2.5 up to study End (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.|||events per person-year|||Number
2751415|NCT00865904|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2751338|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall)|SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.|From Month 2.5 to Month 20|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751339|NCT00866619|Secondary|Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center|PCD = malaria episode with PFAP > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease (see below endpoints on severe malaria for details). Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are by center and across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.|From Month 2.5 to Month 20|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.|||events per person-year|||Number
2751340|NCT00866619|Secondary|Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3|PCD=malaria episode with P. falciparum asexual parasitemia (PFAP) > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease. SCD1=malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2=malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3=malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.|From Month 2.5 to Month 14|The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751341|NCT00866619|Primary|Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)|A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia > 5000 parasites/µL was accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 6-12 weeks (6-12W) age category.|From Month 2.5 to Month 14|The analysis was performed on the ATP population for efficacy, which included all children aged 6-12 Weeks who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751342|NCT00866619|Primary|Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)|A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia was greater than (>) 5000 parasites per microliter (µL) accompanied by the presence of fever [axillary temperature greater than or equal to (≥) 37.5°C] at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 5-17 months age category.|From Month 2.5 to Month 14|The analysis was performed on the According-to-Protocol (ATP) population for efficacy, which included all children aged 5-17 Months who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.|||events per person-year|||Number
2751343|NCT00866606|Secondary|Percentage of Participants With Red Blood Cell (RBC) Agglutination|RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.|||Percentage of Participants|||Number
2751344|NCT00866606|Secondary|Percentage of Participants With Thrombosis|Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.|||Percentage of Participants|||Number
2751345|NCT00866606|Secondary|Percentage of Participants With Allergic-Type Allergic Reactions|Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.|||Percentage of Participants|||Number
2751346|NCT00866606|Secondary|Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Percentage of Participants|||Number
2751347|NCT00866606|Secondary|FIX Incremental Recovery|FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.|Baseline (Visit 2) up to 6 months (Visit 4)|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.|||IU/dL per IU/kg||Standard Deviation|Mean
2751348|NCT00866606|Secondary|Number of Infusions Required to Treat Each Bleed|The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Infusions||Standard Deviation|Mean
2751349|NCT00866606|Primary|Percentage of Participants With FIX Inhibitor Development|Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Baseline up to 6 months|Safety Set (SS) population included all enrolled participants who had taken at least 1 dose of drug.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.|||Percentage of Participants|||Number
2751350|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|24 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
2751351|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|8 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
2751352|NCT00866359|Secondary|Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 197; maximum exposure was 25.1 weeks|Safety analyses for the apremilast-exposure period was based on the apremilast participants as treated (AAT) Population, and included those who were randomized (at the randomization visit) or switched (at the Day 85 visit) to apremilast 30 mg BID, and received at least one dose of apremilast after the initial randomization or switch to 30 mg BID.|||particpants|||Number
2751353|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase|||units on a scale||Standard Deviation|Mean
2751354|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 197|Not analyzed due to low numbers of genital ulcers; not considered meaningful.||||||
2751355|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response)|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 197|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
2751356|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase.|||units on a scale||Standard Deviation|Mean
2751357|NCT00866359|Secondary|Number of Oral Ulcers at Day 197|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase|||ulcers/participants||Standard Deviation|Mean
2751358|NCT00866359|Secondary|Number of New Manifestations of Behçet's Disease or Flare That Were Not Present at Day 1|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:~Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);~Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;~Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;~Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician's Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician's Global Assessment of Skin Lesions, whichever is greater;~New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||participants|||Number
2751359|NCT00866359|Secondary|Behçet's Disease (BD) Current Activity Index Form Score at Day 169|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Deviation|Mean
2751360|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 169|Not analyzed due to low numbers of genital ulcers; not considered meaningful.||||||
2751361|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 169|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline visit. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
2751362|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Deviation|Mean
2751363|NCT00866359|Secondary|Number of Oral Ulcers at Day 169|The number of oral ulcers were counted at Day 169 in reference to the participants' first day of active treatment (Day 1 or Day 85).|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||ulcers/participant||Standard Deviation|Mean
2751416|NCT00865904|Secondary|Maximum Plasma Concentration (Cmax) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, 24, and 30-60 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2751364|NCT00866359|Secondary|Number of New Manifestations of Behçet's Disease or Flare During the Placebo Controlled Treatment Phase|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:~Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);~Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;~Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;~Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician's Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician's Global Assessment of Skin Lesions, whichever is greater'~New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 85|Safety population included all participants who were randomized and received at least 1 dose of Investigational Product.|||participants|||Number
2751365|NCT00866359|Secondary|Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase|A Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase|Safety Population defined as all participants who were randomized and received at least 1 dose of Investigational Product.|||participants|||Number
2751366|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 85 or to early termination visit|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Error|Least Squares Mean
2751367|NCT00866359|Secondary|Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)|Comparison of the percentage of participants who were oral ulcer-free (complete response: free from active oral ulcers), or whose oral ulcers were reduced by ≥ 50%, (partial response) between the apremilast-treated and the placebo-treated groups. In this case, partial response also includes complete response.|Baseline and Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
2751368|NCT00866359|Secondary|Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85|Sum of the number oral ulcers, genital ulcers or oral plus genital ulcers at Day 85|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||Ulcers/participants||Standard Error|Least Squares Mean
2751369|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85|Area under curve (AUC) from Day 1 to Day 85 (AUC^85) for the number of oral plus genital ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||total AUC (#ulcers*days)||Standard Deviation|Mean
2751370|NCT00866359|Secondary|Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of genital ulcers per day was not analyzed.|Day 1 to Day 85|No population analyzed due to small number of participants with genital ulcers; not considered meaningful.||||||
2751371|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of oral ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||total AUC (#ulcers*days)||Standard Error|Least Squares Mean
2751372|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Baseline to Day 85|Not analyzed due to low numbers of genital ulcers; not considered meaningful.||||||
2751502|NCT00864513|Secondary|Number of Participants With Adverse Events|Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0|30 days after last dose of study drug||||participants|||Number
2751374|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Error|Least Squares Mean
2751375|NCT00866359|Primary|Number of Oral Ulcers at Day 85|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 85|Intent to Treat (ITT) = all randomized participants with at least one oral ulcer evaluation (including the baseline visit). A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||ulcers/participants||Standard Error|Least Squares Mean
2751376|NCT00866333|Secondary|Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Treatment-Emergent Adverse Event (TEAE) is an AE that occurred after receive study drug. Any changes from baseline in vital signs, electrocardiogram results, and laboratory parameters assessed by the investigator to be clinically significant were reported as AEs. A SAE is defined as an AE that: is fatal, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect, is another significant medical hazard, such as new malignancy.|First dose to within 30 days of the last dose of study drug (Up to 34 months)|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2751377|NCT00866333|Secondary|Duration of Objective Response for Participants Achieving CR or PR|Duration of objective response was defined as the number of days from the start date of CR or PR (whichever status is recorded first), until the first date that recurrent or progressive disease was objectively documented.|Regimen 1 and 2 median follow-up 36.6 months; Regimen 3 median follow-up 18.4 months|PP population included all participants who met all of the following criteria: Completed at least 2 cycles of entinostat therapy and Underwent CT or PET scans at Screening and Day 1 of Cycle 3. Analysis included all participants who achieved CR or PR.|||months||95% Confidence Interval|Median
2751378|NCT00866333|Secondary|Percentage of Participants With Best Overall Response Based on the Participant's Best Response Documented Through the Entire Course of Protocol Therapy|Best Overall Response was defined as Complete Response (CR) or Partial Response (PR). Tumor response was assessed by the Investigators using the International Working Group revised response criteria for malignant lymphoma (Cheson, Pfistner et al. 2007). CR was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to HL. PR was defined as: At least a 50% decrease in sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses, No increase in the size of other nodes, No new sites of disease.|Regimen 1 and 2 median follow-up 36.6 months; Regimen 3 median follow-up 18.4 months|PP population included all participants who met all of the following criteria: Completed at least 2 cycles of entinostat therapy and Underwent CT or PET scans at Screening and Day 1 of Cycle 3.|||percentage of participants||95% Confidence Interval|Number
2751379|NCT00866333|Primary|Percentage of Participants With Best Overall Response Based on the Participant's Best Response That is Documented Within the First 6 Cycles of Protocol Therapy|Best Overall Response was defined as Complete Response (CR) or Partial Response (PR). Tumor response was assessed by the Investigators using the International Working Group revised response criteria for malignant lymphoma (Cheson, Pfistner et al. 2007). CR was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to HL. PR was defined as: At least a 50% decrease in sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses, No increase in the size of other nodes, No new sites of disease.|Up to 6 months|Per-Protocol (PP) population included all participants who met all of the following criteria: Completed at least 2 cycles of entinostat therapy and Underwent computed tomography (CT) or positron emission tomography (PET) scans at Screening and Day 1 of Cycle 3.|||percentage of participants||95% Confidence Interval|Number
2751380|NCT00866320|Secondary|Duration of Overall Response (Tumor Burden Reduction)|Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|followed for overall response for approximately 3 years|Patients who achieved at least 5% tumor reduction|||months||95% Confidence Interval|Median
2751381|NCT00866320|Secondary|Time to Progression|"Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.~Progression-free survival measured in months and summarized using the Kaplan-Meier method."|followed to progression for approximately 3 years|All patients who started treatment|||months||95% Confidence Interval|Median
2751382|NCT00866320|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.|followed until progression or death for approximately 3 years|All patients who started treatment|||months||95% Confidence Interval|Median
2752007|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 1|Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg|baseline, week 1|FAS (LOCF)|||participants|||Number
2751383|NCT00866320|Primary|Tumor Burden Reduction Rate (TBRR)|The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.|at 8 weeks (2cycles of treatment)|All patients who started treatment|||percentage of patients|||Number
2751384|NCT00866307|Primary|AALL08P1 Feasibility Outcome|Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)|||percentage of participants||90% Confidence Interval|Number
2751385|NCT00866307|Primary|AALL08P1 Safety Outcome|Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)|||percentage of participants||90% Confidence Interval|Number
2751386|NCT00866294|Secondary|Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8|The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.|||percentage of responders|||Number
2751387|NCT00866294|Secondary|Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8|The 7-point CGI-SI scale assesses the clinician's impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.|||scores on a scale||Standard Deviation|Mean
2751388|NCT00866294|Secondary|Percentage of HAM-D Remitters at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.|||percentage of remitters|||Number
2751389|NCT00866294|Secondary|Percentage of HAM-D Responders at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.|||percentage of responders|||Number
2751390|NCT00866294|Secondary|Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the following datasets: the observed case (OC) dataset for Week 1 and the LOCF dataset for Weeks 2, 3, 4, 6, and 8, where missing values were imputed by the last observed value in the longitudinal data. One participant in the Paroxetine CR group was not included in the OC analysis for having a missing value.|||scores on a scale||Standard Deviation|Mean
2751391|NCT00866294|Primary|Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8|The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.|Baseline (Week 0) and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase (8 weeks), excluding those who had taken no dose of the investigational product for the treatment phase and who had no data on the HAM-D total score after the start of the treatment phase. The analysis was performed on the last observation carried forward (LOCF) dataset.|||scores on a scale||Standard Error|Mean
2751405|NCT00866047|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment|||participants|||Number
2751392|NCT00866281|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.|||Participants|||Number
2751393|NCT00866281|Secondary|Plasma Concentrations of Midostaurin and Its Metabolites CGP52421 and CGP62221|The plasma concentrations of midostaurin (PKC412) and its two major metabolites, CGP62221 and CGP52421 were determined by using a validated liquid chromatography/tandem mass spectrometry method.|Day 1, Day 5, Day 7, Day 15 (Day 1 of Cycle 2), Day 29 (Day 1 of Cycle 3)|The analysis was performed in pharmacokinetic (PK) set population defined as all safety set participants who had at least one valid (measurable) PK sample of midostaurin, and who had no significant restricted co-medications.|||nanograms/milliliters (ng/mL)||Standard Deviation|Mean
2751394|NCT00866281|Secondary|Overall Survival With Midostaurin|Overall survival (OS) was defined as the time from start of treatment to date of death due to any cause. The percentage (%) event-free probability estimates were obtained from the Kaplan-Meier survival estimates.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in FAS population.|||Months||95% Confidence Interval|Median
2751395|NCT00866281|Secondary|Time to Response With Midostaurin|Time to response was defined as the time from the date of start of midostaurin treatment to the date of first response. The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Time to response was calculated by using the formula = (date of first response -date of start of midostaurin) +1 day.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|"The analysis was performed in FAS population. Here, Number of participants analysed signifies number of responders at specified time points for each arm, respectively."|||Days||Full Range|Median
2751396|NCT00866281|Secondary|Percentage of Participants With Best Overall Response by Indication|The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Participants with stable disease, progressive disease and with missing tumour assessment or who discontinued the study or who died before having their first assessment were considered as non-responders. Stable disease was defined as failure to achieve any of the above response. Progressive disease was defined as doubling of the bone marrow blast percentage from baseline in participants with <40% bone marrow blasts at baseline, or a 50% increase in bone marrow blast percentage from baseline in participants with >40% bone marrow blasts at baseline,|Baseline, Day 15 (Day 1 of Cycle 2), Day 22 (Day 8 of Cycle 2), Day 29(Day 1 of Cycle 9), End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in full analysis set (FAS) population, defined as all participants to whom study treatment was assigned.|||Percentage of Participants|||Number
2751397|NCT00866281|Primary|Maximum Tolerated Dose (MTD) of Midostaurin- Posterior Probability of DLT|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT), based on a Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. A DLT was defined as a grade 3 or 4 non-hematological adverse event (AE) or abnormal laboratory value related to study drug. Mean and the 95% posterior probability estimates of having a DLT by age strata and dose is presented. Estimation of MTD and/or recommended dose for expansion (RDE) at the dose-escalation phase of the study was based upon the estimation of the probability of DLT for participants in the dose-determining set (DDS).|Baseline, End of dose escalation phase (6 months)|The analysis was performed in dose determining set (DDS) population. Here, 'n' signifies the number of evaluable participants for this measure.|||probability estimates||97.5% Confidence Interval|Mean
2751398|NCT00866177|Primary|Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST|Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST|Up to 4 weeks||||participants|||Number
2751399|NCT00866047|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||days||Full Range|Median
2751400|NCT00866047|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2751401|NCT00866047|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline|||percent of participants||95% Confidence Interval|Number
2751402|NCT00866047|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2751406|NCT00866047|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 7 years|Intention to treat|||months||95% Confidence Interval|Median
2751417|NCT00865904|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Domain Scores at Day 28|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. CFQ-R domains include: Body, Digestion, Eat, Emotion, Health Perceptions, Physical, Respiratory, Role, Social, Treatment Burden, Vitality, and Weight. Individual domain score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||units on a scale||95% Confidence Interval|Least Squares Mean
2751418|NCT00865904|Secondary|Change From Baseline in Nasal Potential Difference (NPD) of Zero Chloride Plus Isoproterenol Response at Day 28|"Nasal potential difference (NPD) provides a direct and sensitive evaluation of sodium and chloride transport in secretory epithelial cells via assessment of transepithelial bioelectric properties. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol is reported.~NPDs were performed according to Cystic Fibrosis Foundation Therapeutics Development Network (CFFT TDN) Standard Operating Procedure (SOP) 528.00 Standardization of Measurement of Nasal Membrane Transepithelial Potential Difference (NPD) - electronic data capture (EDC) and Perfusion or Perfusion-Free Probe."|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||millivolts (mV)||95% Confidence Interval|Least Squares Mean
2751419|NCT00865904|Secondary|Change From Baseline in Sweat Chloride at Day 28|Sweat samples were collected using an approved Macroduct (Wescor) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2751420|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Flow Over the Middle Half of the FVC (FEF25-75) at Day 28|FEF25-75 is total volume of air exhaled from the lungs over the middle half of the FVC test, expressed as liters per second (L/sec).|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||liters per second (L/sec)||Standard Deviation|Mean
2751421|NCT00865904|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Day 28|FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||liters||Standard Deviation|Mean
2751422|NCT00865904|Secondary|Change From Baseline in Percent Predicted FEV1 at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2751423|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed signifies participants evaluable for this outcome.|||liters||95% Confidence Interval|Least Squares Mean
2751424|NCT00865904|Primary|Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. An AE that started at or after initial dosing of study drug, or increased in severity after initial dosing of study drug visit is considered treatment-emergent.|Up to 14 days after last dose (last dose = Day 28)|Safety set included all participants who received at least 1 dose of study drug.|||participants|||Number
2751425|NCT00865709|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks|Duration of response was the time from the first documented CR or PR until the first documented PD or death (if before progression). Only responders (CR or PR) were included in the analysis|||months||95% Confidence Interval|Number
2751426|NCT00865709|Secondary|Overall Response|Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|||participants|||Number
2751427|NCT00865709|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|||Months||95% Confidence Interval|Median
2751428|NCT00865709|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until 33 months later.||||days||95% Confidence Interval|Median
2752008|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 2|SBP < 140 mmHg and DBP < 90 mmHg|week 2|FAS (LOCF)|||participants|||Number
2751429|NCT00865709|Primary|Progression-Free Survival (PFS)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|||Months||95% Confidence Interval|Median
2751430|NCT00865566|Primary|Number of Participants Experiencing Systemic Reactogenicity|For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.|Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination|All enrolled participants|||Participants|||Count of Participants
2751431|NCT00865566|Primary|Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration|For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.|Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination|All enrolled participants|||Participants|||Count of Participants
2751432|NCT00865566|Primary|Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness|For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.|Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination|All Enrolled Participants|||Participants|||Count of Participants
2751433|NCT00865566|Primary|HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit|For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.|Enrollment through Month 24 visit|Modified Intent-to-Treat Cohort|||participants|||Number
2751434|NCT00865566|Primary|HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit|For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.|Enrollment through Month 48 visit|Modified Intent-to-Treat Cohort|||participants|||Number
2751435|NCT00865566|Primary|Participant Dropout After Unblinding|"The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.~For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match."|April 23, 2013 through trial closure (up to Month 48 visit)|MITT population participants who were HIV-uninfected and on-study as of April 23, 2013|||Participants|||Count of Participants
2751436|NCT00865566|Primary|Participant Dropout Prior to Unblinding|"The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.~For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match."|Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)|MITT population|||Participants|||Count of Participants
2751437|NCT00865566|Primary|Participant Dropout Through Month 48|For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.|Enrollment through Month 48 visit|MITT population|||Participants|||Count of Participants
2751438|NCT00865514|Secondary|Inhibition of Tyrosine and Individual's Haplotype|Given the infusion of the above amino acids and DCA administration the inhibition of tyrosine will be measured in the KRT haplotype and non KRT haplotype.|one week|No statistical analysis. The data was incomplete and was not analyzed.||||||
2751439|NCT00865514|Primary|The Interaction of DCA and/or Tyrosine Breakdown Products and Maleylacetoacetate Isomerase (MAAI) in Vivo.|"Subjects are administered an infusion of the amino acids leucine and tyrosine. The next day they start a five day course of dichloroacetate(DCA). At the end of five days they receive another infusion of tyrosine and leucine.~The pharmacokinetics of DCA is calculated following the second infusion."|One week|No statistical analysis. The data was incomplete and was not analyzed.||||||
2752009|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 1|Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg|week 1|FAS (LOCF)|||participants|||Number
2751440|NCT00865345|Secondary|Device Related Moderate or Device Related Severe Adverse Events|Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.|days one through six of sensor wear||||events|||Number
2751441|NCT00865345|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|61 subjects of 63 enrolled subjects (a total of 4971 paired YSI and sensor readings) completed participation in the inpatient frequent blood sampling procedure.|||paired YSI/sensor glucose values|Participants|95% Confidence Interval|Number
2751442|NCT00865306|Other Pre-specified|Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up|"Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated 1, very much improved or 2, much improved. Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition)."|1-Year Follow-Up|"We tabulated the number of children that were much or very much improved on anxiety since baseline. Note that the controls who were followed up at one-year were those who subsequently received CBT (after participating in the wait-list condition). Therefore the No intervention (wait-list controls) followed up here had actually received CBT."|||Participants|||Number
2751443|NCT00865306|Other Pre-specified|Number of Children Free of Anxiety Disorders|Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.|Post-Treatment (6-months from baseline)||||Participants|||Number
2751444|NCT00865306|Primary|Number of Responders Based on Clinician Global Impression-Anxiety Improvement|"Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with very much or much improvement (CGI-Anxiety scores of 1 or 2)"|Post-Treatment (6-months from baseline)||||Participants|||Number
2751445|NCT00865202|Secondary|Length of Post-operative ICU and Hospital Stay||length of post-op hospital stay||||days||Standard Deviation|Mean
2751446|NCT00865202|Secondary|Level of Post-operative Melatonin||Blood draw on post-operative day number two||||pg/mL||Standard Deviation|Mean
2751447|NCT00865202|Secondary|Level of Post-operative Serum Tryptophan||post-operative day number two blood draw||||umol/L||Standard Deviation|Mean
2751448|NCT00865202|Secondary|Incidence of Post-operative Delirium|"The incidence and/or duration of excitatory (hyperactive and mixed) post-operative delirium, diagnosed by the Confusion Assessment Method-ICU (CAM-ICU) with the Richmond Agitation Sedation Score (RASS), will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.~The incidence and/or duration of all types of post-operative delirium, diagnosed by the CAM-ICU with the RASS, will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission."|post-operatively daily in ICU until discharged from ICU||||percentage of patient escitatorydelirium|||Number
2751449|NCT00865202|Primary|Duration of Post-operative Delirium||post-operatively daily in ICU until discharged from ICU||||days||Standard Deviation|Mean
2751450|NCT00865189|Secondary|Percentage of Participants With Surgery|The surgery involving a radical rectal excision using the TME technique.|Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment|ITT population|||percentage of participants|||Number
2751451|NCT00865189|Secondary|Number of Cycles of Radiotherapy||Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7|ITT population|||cycles||Standard Deviation|Mean
2751452|NCT00865189|Secondary|Number of Cycles of Chemotherapy||Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7|ITT population|||cycles||Standard Deviation|Mean
2751453|NCT00865189|Secondary|Number of Cycles of Induction Chemotherapy||6 cycles (12 weeks; cycle length = 14 days)|ITT population. Only Arm A participants received induction treatment.|||cycles||Standard Deviation|Mean
2751454|NCT00865189|Secondary|Overall Survival|The overall survival was defined as the time from the first treatment intake to death from any cause.|From the first treatment administration to the date of death (up to approximately 6 years)|ITT population|||months||95% Confidence Interval|Median
2751455|NCT00865189|Secondary|Percentage of Participants Who Died||Baseline up to approximately 6 years|ITT population|||percentage of participants|||Number
2751456|NCT00865189|Secondary|Disease-Free Survival (DFS)|The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.|From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)|ITT population|||months||95% Confidence Interval|Median
2751457|NCT00865189|Secondary|Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death||Baseline up to approximately 6 years|ITT population|||percentage of participants|||Number
2751458|NCT00865189|Secondary|Percentage of Participants With Local and Distant Recurrences|The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population|||percentage of participants||95% Confidence Interval|Number
2751495|NCT00864708|Secondary|Ashworth Scale|The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)|Day 1 and at 3 months, following treatment||||units on a scale|||Number
2751459|NCT00865189|Secondary|Percentage of Participants With Tumor Down-Staging (ypT0-pT2)|A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable for specified category.|||percentage of participants||95% Confidence Interval|Number
2751460|NCT00865189|Primary|Percentage of Participants With Tumor Sterilization Defined by ypT0-N0|Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2751461|NCT00865124|Secondary|Change in Renal Plasma Flow|Renal vasculature was assessed by examining renal plasma flow, or para-aminohippurate (PAH) clearance, basally and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II.|Baseline and six months|All participants with data available for this outcome measure at the given time-point.|||mL/min/1.73m^2||Standard Deviation|Mean
2751462|NCT00865124|Secondary|Mitral Annulus Velocities on Tissue Doppler (Delta E/e' Ratio), a Measure of Diastolic Function (With Angiotensin II)|Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment; and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II.|Baseline and six months|All participants with data available for this outcome measure at the given time-point.|||ratio||Standard Deviation|Mean
2751463|NCT00865124|Secondary|Change in Mitral Annulus Velocities on Tissue Doppler (Delta E/e' Ratio), a Measure of Diastolic Function|Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment.|Baseline and six months|All participants with data available for this outcome measure.|||ratio||Standard Deviation|Mean
2751464|NCT00865124|Primary|Change in Coronary Flow Reserve From Baseline to 6 Months|Coronary flow reserve (CFR), or myocardial perfusion reserve, was assessed via cardiac positron emission tomography (PET). CFR is the ratio of adenosine-stimulated blood flow through myocardium to resting blood flow through myocardium. An improvement in coronary flow reserve is beneficial.|Baseline and six months|All participants with data available for this outcome measure.|||ratio||Standard Deviation|Mean
2751465|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction|Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
2751466|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction|Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
2751467|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 4 Adverse Event|Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject's health and well-being, and the ability of the subject to function during the event.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
2751468|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
2751469|NCT00865098|Secondary|Best Response Rate|Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population|best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||percentage of participants||95% Confidence Interval|Number
2752010|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 2|DBP < 90 mmHg|week 2|FAS (LOCF)|||participants|||Number
2751470|NCT00865098|Primary|Completion Rate|Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population|time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||percentage of participants||95% Confidence Interval|Number
2751471|NCT00865046|Primary|Pain (WOMAC)|"The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:~Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)"|9 months following baseline||||units on a scale||Standard Error|Mean
2751472|NCT00865020|Secondary|Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.~The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.~The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.|||mmHg||Standard Error|Least Squares Mean
2751473|NCT00865020|Secondary|Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.~The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.~The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.|||mmHg||Standard Error|Least Squares Mean
2751474|NCT00865020|Secondary|Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.|Baseline, 13 weeks|Full Analysis Set consisting of all participants randomized to treatment with measurements at baseline and day 7 of the withdrawal period.|||mmHg||Standard Error|Least Squares Mean
2751475|NCT00865020|Secondary|Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.|||mmHg||Standard Error|Least Squares Mean
2751476|NCT00865020|Primary|Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.|||mmHg||Standard Error|Least Squares Mean
2751477|NCT00864916|Primary|Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation (% dilation of the brachial artery) at week 48|Measured at Week 48|Numbers of participants who completed the week 48 visit procedures|||percent dilation of the brachial artery||Standard Deviation|Mean
2751478|NCT00864851|Secondary|Safety Evaluation|Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.|56 Weeks|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal. Analyses were performed on the ITT population because it was identical to the safety population.|||participants|||Number
2751479|NCT00864851|Secondary|Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||mg/g||Standard Deviation|Mean
2751480|NCT00864851|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||mL/min/1.73m^2||Standard Deviation|Mean
2751481|NCT00864851|Secondary|Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||nmol/ml||Standard Deviation|Mean
2751482|NCT00864851|Secondary|Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class|"The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life.~NYHA Classification - The Stages of Heart Failure:~Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).~Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||participants|||Number
2751483|NCT00864851|Secondary|Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score|Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||scores on a scale||Standard Deviation|Mean
2751484|NCT00864851|Secondary|Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)|Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||m||Standard Deviation|Mean
2751485|NCT00864851|Secondary|Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise|Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||mL/min/kg||Standard Deviation|Mean
2751486|NCT00864851|Primary|Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)|Left ventricular mass (LVM) was measured through echocardiography.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||g/m^2.7||Standard Deviation|Mean
2751487|NCT00864721|Secondary|Time to Progression (TTP)|TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|All patients were followed until progressive disease or death, up to 36 months.|ITT population|||months||Full Range|Median
2751488|NCT00864721|Secondary|1-year Overall Survival (OS) Rate.|OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.|All patients were followed until death or up to 36 months.|ITT population|||percentage of participants alive at 1yr||95% Confidence Interval|Number
2751489|NCT00864721|Secondary|Progression-free Survival (PFS)|PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|All patients were followed until progressive disease or death, up to 36 months.|ITT population|||months||Full Range|Median
2751490|NCT00864721|Secondary|Overall Response Rates (OR)|Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 6 weeks until progressive disease or death due to any causes, up to 36 months.|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2751491|NCT00864721|Primary|Disease Control Rate (DCR)|Disease control rate = CR + PR + SD>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Every 6 weeks until progressive disease or death due to any cause, up to 36 month.|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2751492|NCT00864708|Primary|Kinematic Gait Measures|assessment of the lower limb kinematics during ambulation at chosen speed.|Day 1 and at 3 months, following treatment||||percentage of change Day 1 to 3 months|||Number
2751493|NCT00864708|Secondary|Manual Muscle Testing (MMT)|This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)|Day 1 and at 3 months, following treatment||||units on a scale|||Number
2751494|NCT00864708|Secondary|Stroke Impact Scale (SIS)|The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).|Day 1 and at 3 months, following treatment||||units on a scale|||Number
2751503|NCT00864513|Secondary|CA 19-9 Response|CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.|Within two months of the last dose of chemotherapy|Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint|||participants|||Number
2751504|NCT00864513|Secondary|Objective Response|Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0|Within two months of the completion of the last dose of chemotherapy||||participants|||Number
2751505|NCT00864513|Primary|Progression-free Survival|Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.|6 months after last patient enrolled||||days||Full Range|Median
2751506|NCT00864474|Secondary|Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri||Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set. Here, “Overall Number of Participants Analyzed” included participants evaluable for this measure. 'n' signifies participants who were evaluable for this measure at specified timepoints.|||Log HIV-RNA copies/mL||Standard Deviation|Mean
2751507|NCT00864474|Secondary|Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants|CCR5= C-C chemokine receptor type 5 and CXCR4= C-X-C chemokine receptor type 4. Tropism switch is the mutation of CCR5-tropic HIV-1 to a CXCR4-using virus.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|"The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2751508|NCT00864474|Secondary|Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri|CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of many of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints.|||CD4 cells/mm^3||Standard Deviation|Mean
2751509|NCT00864474|Secondary|Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri|HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints.|||Log HIV-RNA copies/mL||Standard Deviation|Mean
2751510|NCT00864474|Secondary|Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection|CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints.|||CD4 cells/mm^3||Standard Deviation|Mean
2751511|NCT00864474|Secondary|Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection|HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints.|||Log HIV-RNA copies/mL||Standard Deviation|Mean
2751519|NCT00864474|Primary|Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.|||ADRs|||Number
2751520|NCT00864474|Primary|Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.|||ADRs|||Number
2751512|NCT00864474|Secondary|Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification|CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the AIDS diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints.|||CD4 cells/mm^3||Standard Deviation|Mean
2751513|NCT00864474|Secondary|Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification|Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as follows: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute (primary) HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged >=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints.|||Log HIV-RNA copies/mL||Standard Deviation|Mean
2751514|NCT00864474|Secondary|Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities|CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints.|||CD4 cells/mm^3||Standard Deviation|Mean
2751515|NCT00864474|Secondary|Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities|HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints.|||Log HIV-RNA copies/mL||Standard Deviation|Mean
2751516|NCT00864474|Secondary|Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender|CD4+ Lymphocyte were counted by CD4 cells per cubic millimeter (cells/mm^3). CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom info sirmation about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints.|||CD4 cells/mm^3||Standard Deviation|Mean
2751517|NCT00864474|Secondary|Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender|HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies per milliliter (copies/mL). The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.|Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84|Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints.|||Log HIV-RNA copies/milliliter(mL)||Standard Deviation|Mean
2751518|NCT00864474|Primary|Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included all participants who met the criteria for participants and were confirmed to have received at least one dose of Celsentri.|||ADRs|||Number
2751569|NCT00864227|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56||||participants|||Number
2751521|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean total dose of Celsentri are reported to assess mean total dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean total dose of Celsentri.|||percentage of participants|||Number
2751522|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by total number of days of administration of Celsentri are reported to assess total number of days of administration of Celsentri as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per total number of days of administration of Celsentri.|||percentage of participants|||Number
2751523|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant CYP3A4 enzyme inducer use are reported to assess presence or absence of concomitant CYP3A enzyme inducer use as a risk factor for ADR. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducer for enzyme CYP3A4.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant CYP3A enzyme inducer use.|||percentage of participants|||Number
2751524|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant therapies are reported to assess presence or absence of concomitant therapies as a risk factor for ADR. Concomitant therapies were the treatments taken by participants to treat comorbid conditions.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant therapies.|||percentage of participants|||Number
2751525|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification|An ADR:any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by physician.Participants are divided into 3 categories as per CDC classification based on level of HIV infection: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in adult or adolescent aged>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Unknown: Participants for which CDC classification was not described.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per CDC classification.|||percentage of participants|||Number
2751526|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by number of concomitant anti-HIV treatment are reported to assess number of concomitant anti-HIV treatment as a risk factor for ADR. Concomitant drugs refers to the drugs other than Celsentri.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per number of concomitant anti-HIV treatments use.|||percentage of participants|||Number
2751527|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean daily dose of Celsentri are reported to assess mean daily dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean daily dose of Celsentri.|||percentage of participants|||Number
2751528|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hemophilia are reported to assess presence or absence of hemophilia as a risk factor for ADR. Hemophilia is a bleeding disorder that slows the blood clotting process. Participants with this condition experience prolonged bleeding or oozing following an injury, surgery, or having a tooth pulled.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hemophilia.|||percentage of participants|||Number
2751529|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hepatic impairment are reported to assess presence or absence of hepatic impairment as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hepatic impairment.|||percentage of participants|||Number
2751530|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of renal impairment are reported to assess presence or absence of renal impairment as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of renal impairment.|||percentage of participants|||Number
2751531|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of comorbidities are reported to assess presence or absence of comorbidities as a risk factor for ADR. Comorbidity referred to the presence of co-existing or additional diseases along with HIV infection.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of comorbidities.|||percentage of participants|||Number
2751532|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of allergies are reported to assess presence or absence of allergies as a risk factor for ADR. Unknown: participants for which the presence or absence of allergies was not known.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of allergies.|||percentage of participants|||Number
2751533|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by HIV infection duration are reported to assess HIV infection duration as a risk factor for ADR. Unknown: participants for which the duration of HIV infection was not known.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per duration of HIV infection.|||percentage of participants|||Number
2751534|NCT00864474|Primary|Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of history of therapies for HIV Infection are reported to assess presence or absence of history of therapies for HIV Infection as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of history of therapies for HIV Infection.|||percentage of participants|||Number
2751570|NCT00864227|Secondary|Platelet Recovery to 20K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >20,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
2751571|NCT00864227|Secondary|Secondary Graft Failure|Secondary graft failure is defined initial recovery followed by neutropenia with < 5% donor chimerism.|Measured at Day 100||||participants|||Number
2751535|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by ethnicity are reported to assess ethnicity as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per ethnicity.|||percentage of participants|||Number
2751536|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by inpatient or outpatient status are reported to assess inpatient or outpatient status as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per inpatient or outpatient status.|||percentage of participants|||Number
2751537|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age|"An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by age are reported to assess age as a risk factor for ADR. >= refers to greater than or equal to."|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per age.|||percentage of participants|||Number
2751538|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by gender are reported to assess gender as a risk factor for ADR.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, number analyzed ('n') signifies participants who were evaluable for this outcome measure as per gender.|||percentage of participants|||Number
2751539|NCT00864474|Primary|Number of Participants With Unknown Adverse Drug Reactions (ADRs)|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. Unknown ADRs were the ADRs those were not listed on the package insert.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.|||Participants|||Count of Participants
2751540|NCT00864474|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs)|An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.|From April 2009 to December 2018 (up to approximately 8 years 8 months)|The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.|||percentage of participants|||Number
2751541|NCT00864383|Secondary|Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.|"Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (isolated positive culture) was followed by at least two negative culture results."|18 months||||participants with unfavorable outcome|||Number
2751542|NCT00864383|Secondary|Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.|"Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (isolated positive culture) was followed by at least two negative culture results."|18 months|All randomized subjects.|||participants with unfavorable outcome|||Number
2751543|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (MGIT Liquid Media)||18 months|All randomized patients excluding late screen failures|||Time to culture negative status / weeks||95% Confidence Interval|Median
2751544|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (LJ Solid Media)|Culture negative for TB using LJ cultures.|18 months|All randomized patients excluding late screen failures|||Time to culture negative status / weeks||95% Confidence Interval|Median
2751545|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Liquid MGIT Culture)|Number of patients who are TB MGIT culture negative at 8 weeks.|8 weeks||||participants who are culture negative|||Number
2751546|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Solid LJ Culture)|Number of patients who are TB LJ culture negative at 8 weeks.|8 weeks|Per protocol|||participants who are culture negative|||Number
2751572|NCT00864227|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements prior to and day-100.|Measured at Day 100||||participants|||Number
2751573|NCT00864227|Secondary|Neutrophil Recovery|Neutrophil recovery is defined as achieving an absolute neutrophil count ≥ 500/mm3 for three consecutive measurements on different days.|Measured at Days 28, 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
2751547|NCT00864383|Secondary|Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).|The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.|18 months (within one year of completion of therapy)|Per protocol population|||participants with failure or relapse|||Number
2751548|NCT00864383|Primary|Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)|The number of participants includes all patients who had at least one grade 3 or 4 adverse event.|18 months (within one year of completion of therapy)|Safety population, defined as all subjects who underwent randomization and who received at least on dose of study drug.|||participants with Grade 3 or 4 AEs|||Number
2751549|NCT00864383|Primary|Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).|The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.|18 months (within one year of completion of therapy)|Per protocol population|||participants with failure or relapse|||Number
2751550|NCT00864253|Secondary|Pharmacokinetic Parameters||On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose|Patients randomized to receive ABI-007 treatment in Australia, Canada, Europe, United Kingdom and United States had the option to participate in sparse PK sampling in this study. Only 44 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed||||||
2751551|NCT00864253|Secondary|Nadir for the Hemoglobin Count Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included.|||g/L||Full Range|Median
2751552|NCT00864253|Secondary|Nadir for Platelet Count Measurements.|Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included|||10^9/L||Full Range|Median
2751553|NCT00864253|Secondary|Nadir for White Blood Cells (WBCs) Measurements|Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included|||10^9/L||Full Range|Median
2751554|NCT00864253|Secondary|Nadir for the Absolute Neutrophil Count (ANC) Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated Population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included|||10^9/L||Full Range|Median
2751555|NCT00864253|Secondary|Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum study drug exposure 106 weeks; data cut off 30 June 2012|Treated population|||participants|||Number
2751556|NCT00864253|Secondary|Summary of Treatment-emergent Adverse Events (AEs)|"A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE's were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale:~Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012|Treated Population = The Treated population consisted of all randomized participants who received at least one dose of study drug|||participants|||Number
2751574|NCT00864227|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1||||percentage of participants||95% Confidence Interval|Number
2751773|NCT00862459|Secondary|Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI|The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.|up to 2 hours after the injection of study medication|PPS|||percentage of exact matches|||Number
2751557|NCT00864253|Other Pre-specified|Duration of Response (DOR) in Responding Participants|Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #4. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|up to data cut off 30 June 2012|ITT of participants with a confirmed complete or partial overall response|||months||95% Confidence Interval|Median
2751558|NCT00864253|Other Pre-specified|Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012|ITT|||percent of participants|||Number
2751559|NCT00864253|Other Pre-specified|Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.|every 8 weeks; up to data cut off 30 June 2012|ITT|||percentage of participants|||Number
2751560|NCT00864253|Other Pre-specified|Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.|Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months|ITT|||months||95% Confidence Interval|Median
2751561|NCT00864253|Secondary|Participant Survival|Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.|Up to 38 months; Up to data cut off of 30 June 2012|Intent to treat population|||months||95% Confidence Interval|Median
2751562|NCT00864253|Primary|Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.|Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012|Intent to treat population = The ITT population consisted of all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
2751563|NCT00864227|Secondary|Platelet Recovery to 50K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >50,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
2751564|NCT00864227|Secondary|Incidence of Infections|Number of participants that experienced at least one infection.|Measured at Year 1||||Infections|||Number
2751565|NCT00864227|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
2751566|NCT00864227|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval to relapse/ recurrence/progression, to death or to last follow-up.|Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
2751567|NCT00864227|Secondary|Chronic GVHD||Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
2751568|NCT00864227|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100||||percentage of participants||95% Confidence Interval|Number
2751575|NCT00864123|Secondary|Adverse Symptom Checklist (ASC; Goodman, 2005).|This index assesses adverse side effects that have been associated with DCS, as well as other commonly used psychotropic agents (e.g., SRIs). There are no summary scales for this. Rather, it reflects the presence or absence of 30 potential side effects on a 0-3 scale (0=not at all, 1=slight, 2=moderate, 3=severe) that are associated with study interventions.|Baseline, mid-treatment, post-treatment|Number of participants experiencing an adverse effect related to study interventions. This is a simple frequency count.|||participants|||Number
2751576|NCT00864123|Secondary|Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|"The CGI-S is a 7-point clinician rating of severity of psychopathology. Ratings range from 1 (no illness) to 7 (extremely severe). A single rating is chosen for the CGI-S; thus, there are no summary scales/scores."|Baseline, mid-treatment, post-treatment||||units on a scale||Standard Deviation|Mean
2751577|NCT00864123|Primary|Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997).|The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. This measure served as the primary outcome index. Scores range from 0-40 with higher scores representing more severe symptoms.|Baseline, Mid-Treatment, Post-treatment||||units on a scale||Standard Deviation|Mean
2751578|NCT00864084|Primary|Standing Balance - Critical Point in Distance|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||cm||Standard Deviation|Mean
2751579|NCT00864084|Primary|Standing Balance - Critical Point in Time|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||s||Standard Deviation|Mean
2751580|NCT00864084|Secondary|Confidence in Disease Management|"The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}. Possible answers range from very confident (5 points) to not at all confident (1 point) and the average score per question is calculated. This scale has been shown to have excellent internal consistency and good test-retest reliability."|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||scores on a scale||Standard Deviation|Mean
2751581|NCT00864084|Secondary|Fear of Falling|"The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}. It asks about an individual's concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions. Answers range from 1, not at all concerned, to 4, very concerned, on a 4-point scale, and score is calculated as the average response. This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}."|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||scores on a scale||Standard Deviation|Mean
2751582|NCT00864084|Secondary|Balance Confidence|Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}. It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident). The score is calculated as the average score for each item. This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||units on a scale||Standard Deviation|Mean
2751583|NCT00864084|Primary|Dynamic Balance|Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST). For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}. Subjects were asked to do this as quickly and safely as possible. High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}. In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}. The time taken to complete this circuit was recorded. This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||seconds||Standard Deviation|Mean
2751584|NCT00864084|Primary|Standing Balance - Sway Path|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||cm/s||Standard Deviation|Mean
2751585|NCT00864032|Primary|Number of Dose Limiting Toxicities|"Number of dose limiting toxicities and number with adverse events.~Dose-escalation schedule comprising 6 to 12 patients (see schema). This sample size is based on a traditional 3+3 cohort design with escalating doses of sorafenib in combination with 50 Gy of conformal radiotherapy delivered in 25 fractions (200 cGy per fraction). Based on preclinical data regarding the radiobiology of sorafenib,33, 36 sorafenib will be initiated at a dose of 200 mg twice daily, followed by 200 mg Q AM/400 mg Q PM for the 2nd cohort, followed by 400 mg bid for the 3rd cohort. Since 400 mg bid is the well established MTD for sorafenib monotherapy in patients with renal cell carcinoma and hepatocellular carcinoma, the dose will not be escalated above this level even if DLT is not observed. Dose level escalation will be determined based on DLTs observed from initiation of sorafenib/RT until time of surgery."|Approximately 12 weeks||||DLTs|||Number
2751982|NCT00860405|Primary|Total Volume of Colloid Solution Required Intraoperatively|Total volume of study drug plus rescue colloid, if applicable|Day 1 (intraoperatively)|Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.|||ml/kg||Standard Deviation|Mean
2751586|NCT00863928|Primary|Pain Assessment by Visual Analog Scale at Rest|"The Pain Assessment by Visual Analog Scale (VAS) consists of 100 millimeter (mm) horizontal line with two endpoints 1-100, labeled no pain and worst possible pain. No pain is the minimum value and worst possible pain is the maximum value.~Minimum value or No Pain is considered a better outcome."|24 hours||||millimeters||Standard Deviation|Mean
2751587|NCT00863798|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS)|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2751588|NCT00863798|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of Yes on Actual Attempt),preparatory acts toward imminent suicidal behavior (3)(Yes on Preparatory Acts or Behavior),suicidal ideation (4)(Yes on Wish to be dead,Non-Specific Active Suicidal Thoughts,Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(Yes on Has subject engaged in Non-suicidal Self-Injurious Behavior)."|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Participants|||Number
2751589|NCT00863798|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Percentage of Participants|||Number
2751590|NCT00863798|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2751591|NCT00863798|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Error|Mean
2751592|NCT00863798|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.|||nanogram(ng)/mL||Standard Deviation|Mean
2751593|NCT00863798|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2751594|NCT00863798|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2751646|NCT00863122|Secondary|Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS.|Due to the sample sizes, a comparison between sporadic and NF2-related vestibular schwannomas could not be made. Instead we report the mutational status.|at time of surgery|6 of the 7 participants had sporadic VS; 1 of 7 had NF2-associated VS. As such, we were unable to explore differences between the groups.|||Participants|||Count of Participants
2751595|NCT00863798|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2751596|NCT00863798|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2751597|NCT00863798|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2751598|NCT00863798|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2751599|NCT00863798|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2751600|NCT00863798|Secondary|Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2751601|NCT00863798|Primary|Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.|||Units on a scale||Standard Error|Mean
2751602|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score|A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement)|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
2751603|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score|The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
2751616|NCT00863655|Secondary|Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier|Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|21 months|Randomized patients with best overall response of CR or PR.|||Months||95% Confidence Interval|Median
2751604|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
2751605|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
2751606|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status|The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
2751607|NCT00863746|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier).|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
2751608|NCT00863746|Secondary|Objective Tumor Response|Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Proportion of participants|||Number
2751609|NCT00863746|Secondary|Disease Control|Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)].|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Proportion of participants|||Number
2751610|NCT00863746|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
2751611|NCT00863746|Primary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.|From randomization of the first subject until 36 months later|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
2751612|NCT00863707|Primary|Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)|"The data represents the numbers of subjects reporting Serious TEAEs.~TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug."|24 hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.|||Subjects|||Number
2751613|NCT00863655|Secondary|Estradiol Plasma Concentrations|Compare estradiol concentrations from baseline to week 4 in both treatment arms.|Baseline, Week 4|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.|||pg/mL||Standard Deviation|Mean
2751614|NCT00863655|Secondary|Exemestane Concentrations at Week 4|Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.|predose, 2 hours post-dose|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
2751615|NCT00863655|Secondary|Everolimus Concentrations at Week 4|Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.|pre-dose, 2 hours post-dose|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
2751617|NCT00863655|Secondary|Proportion of Patients With Having no Overall Response Based on Investigator Assessment|overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|2, 4, 6, 9 months|All randomized patients were included in the Full Analysis Set.|||Proportion of patients||95% Confidence Interval|Number
2751618|NCT00863655|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30|"The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms."|Up to 21 months|All randomized patients were included in the Full Analysis Set.|||Months||95% Confidence Interval|Median
2751619|NCT00863655|Secondary|Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier|The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, & physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature. 2: Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.|2, 4, 6, 9 months|All randomized patients were included in the Full Analysis Set.|||Proportion of patients||95% Confidence Interval|Number
2751620|NCT00863655|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) >= 24 weeks, according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|up to 21 months|All randomized patients were included in the Full Analysis Set.|||Percentage of participants|||Number
2751621|NCT00863655|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|up to 21 months|All randomized patients were included in the Full Analysis Set.|||Percentage of participants|||Number
2751622|NCT00863655|Secondary|Overall Survival (OS) by Median|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.|up to 53 months|All randomized patients were included in the Full Analysis Set.|||Months||95% Confidence Interval|Median
2751623|NCT00863655|Secondary|Overall Survival (OS) by Number of Deaths|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|up to 53 months|All randomized patients were included in the Full Analysis Set.|||Participants|||Number
2751624|NCT00863655|Primary|Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.|Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.|date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months|All randomized patients were included in the Full Analysis Set.|||months||95% Confidence Interval|Median
2751625|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.|||Percentage of Subjects|||Number
2751626|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.|||Percentage of Subjects|||Number
2751627|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.|||Percentage of Subjects|||Number
2751628|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.|||Percentage of Subjects|||Number
2751629|NCT00863551|Primary|Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5|Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.|Day 10, Hour 5|Intent-to-treat, which included all patients who started the study.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
2751630|NCT00863512|Primary|Overall Survival|Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 12 years|Study terminated prematurely with 34 participants recruited. Per protocol, 338 events were needed to conduct the primary analysis; therefore, the planned analyses was not performed due to a lack of events and a termination of data collection.||||||
2751631|NCT00863434|Primary|Overall Survival||Every 3 months for 2 years, and then annually for 3 years||||months||Full Range|Median
2751632|NCT00863434|Primary|Disease-free Survival||Every 3 months for 2 years, and then annually for 3 years||||months||Full Range|Median
2751633|NCT00863434|Primary|Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry|Percent of white blood cells that are blasts in the bone marrow post-treatment.|Post-treatment||||percent of white blood cells||Full Range|Median
2751634|NCT00863356|Primary|Hemostasis Success|Successful hemostasis prior to leaving physician's office|From procedure to hemostasis.|All enrolled subjects|||percentage of participants|||Number
2751635|NCT00863356|Secondary|This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.||Removal: 48 hours. Follow-up: 1 week.|||||||
2751636|NCT00863356|Primary|This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.||Removal: 48 hours. Follow-up: 1 week.|||||||
2751637|NCT00863343|Primary|MSD Influenza B Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day||||participants|||Number
2751638|NCT00863343|Primary|MSD Influenza A Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day||||participants|||Number
2751639|NCT00863343|Primary|MSD Influenza B Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day||||participants|||Number
2751640|NCT00863343|Primary|MSD Influenza A Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.|1 day|per protocol|||participants|||Number
2751641|NCT00863330|Primary|Primary Objective|Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.|4-6 weeks after completion of TIL|Study was terminated for administrative reasons. complete data was not collected and no data analysis was completed||||||
2751642|NCT00863317|Primary|Duration of Cough||up to 4 weeks||||days||Inter-Quartile Range|Median
2751643|NCT00863265|Primary|LDL Cholesterol||At the end of week 3 on each diet|Healthy subjects|||mg/deciliter||95% Confidence Interval|Mean
2751644|NCT00863265|Primary|Percent Cholesterol Absorption|Percent of intestinal cholesterol absorbed. Intestinal cholesterol is comprised of dietary cholesterol intake and endogenous cholesterol secreted into the intestinal lumen. Cholesterol absorption is the percent of intestinal cholesterol that is taken back up into the body and excluded from fecal excretion. It is also referred to as the efficiency of intestinal cholesterol absorption.|Determined on the final 5 days of each dietary period||||Percent||95% Confidence Interval|Mean
2751647|NCT00863122|Secondary|Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS.|A comparison in the median lapatinib concentration (ng/g) in vestibular schwannomas associated with neurofibromatosis type 2 and sporadic vestibular schwannomas|one year|Of the nine participants in the lapatinib who had tumor available for analysis, four had a vestibular schwnannoma associated with a diagnosis of neurofibromatosis type 2 (NF2); five had sporadic vestibular schwannomas.|||ng/g||Full Range|Median
2751648|NCT00863122|Secondary|Assess Markers of Tumor Proliferation and Cell Death in VS After Exposure to Lapatinib.||at time of surgery||2020-09-30|09/2020||||
2751649|NCT00863122|Secondary|Assess the Level of ErbB2 Phosphorylation in VS.|Assessed number of samples with high expression of phospho-ErbB2 in tissue at time of surgery|at time of surgery|10 lapatinib participants and 3 control participants did not have adequate tissue for analysis.|||Participants|||Count of Participants
2751650|NCT00863122|Primary|To Assess Whether Lapatinib Can Reach a Minimum Tumor Concentration Level of >3uM in VS After Oral Dosing.|Count of tissue samples with lapatinib concentration >3uM|one year|In the lapatinib group, 10 tissue and plasma samples were lost from analysis due to a freezer failure during a natural disaster denaturing the samples. Nine samples were available for tissue concentration assessment.|||Participants|||Count of Participants
2751651|NCT00863122|Primary|Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection|Steady-state plasma concentrations of lapatinib (ng/mL) at time of surgery, 10-13 days from starting drug.|At time of surgery, 10-13 days from starting drug.|In the lapatinib group, 10 tissue and plasma samples were lost from analysis due to a freezer failure during a natural disaster denaturing the samples. 1 blood sample was contaminated, but tissue was available. Control group did not get any drug. A total of 8 participants of 19 given drug had data for analysis.|||ng/mL||Full Range|Median
2751652|NCT00863109|Secondary|Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)|Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants; participants who had met the evaluation and eligibility criteria and were included in the study. Analysis Population included 53 participants who completed 48 weeks of treatment and 77 participants who did not complete 48 weeks of treatment (early end).|||percentage of participants|||Number
2751653|NCT00863109|Secondary|MCID in CLDQ-HCV Scores|"The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score."|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.|||score on a scale||Standard Deviation|Mean
2751654|NCT00863109|Secondary|Minimal Clinically Important Difference (MCID) in SF-36 Scores|SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.|||score on a scale||Standard Deviation|Mean
2751655|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|"The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life."|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).|||score on a scale||Standard Deviation|Mean
2751666|NCT00863057|Secondary|Quality of Life Measured by SF-36 Healthy Survey (SF-36)|The data for this outcome are not available for the analysis due to an issue with a company which provides software to calculate SF-36.|At the fourth treatment week of each treatment period|||||||
2751667|NCT00863057|Secondary|Pain-related Interference Measured by the Brief Pain Inventory (BPI) Interference Items|"The BPI interference scale measured level of interference with the following seven items:~General activity~Mood~Walking ability~Normal work~Relations with other people~Sleep~Enjoyment of life~Interference scales range from 0='Does not interfere' to 10='Completely interferes'. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively."|At the fourth week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Inter-Quartile Range|Median
2751656|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).|||score on a scale||Standard Deviation|Mean
2751657|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)|"The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life."|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72.|||score on a scale||Standard Deviation|Mean
2751658|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72.|||score on a scale||Standard Deviation|Mean
2751659|NCT00863057|Other Pre-specified|Methadone Trough Level and Weekly Mean Pain Scores|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint.|During the fourth week of each treatment period|This was one of the exploratory objectives and was not analyzed as the study was terminated.||||||
2751660|NCT00863057|Other Pre-specified|Sensory and Affective Qualities of Pain Measured by the McGill Pain Questionnaire - Short Form (MPQ-SF)|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint in the future.|At the fourth treatment week of each treatment period|This was one of the exploratory objectives and was not analyzed as the study was terminated.||||||
2751661|NCT00863057|Secondary|Number of Participants With Treatment-emergent Grade 2 to 4 Adverse Events|The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 was used (see the link to the grading table in Protocol Section)|From study entry to end of study at week 20 or premature study discontinuation|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Participants|||Count of Participants
2751662|NCT00863057|Secondary|Maximum Tolerated Dose of Duloxetine and Methadone||During each treatment period|The number below is the highest tolerated daily dose in mg based on n=12 for Methadone and n=10 for Duloxetine.|||mg|||Number
2751663|NCT00863057|Secondary|Use of Rescue Medication (Acetaminophen)||During each treatment period and the subsequent cross-over (or final study week) period|The analysis was per protocol. Because of a cross-over trial, the # of participants analyzed do not match with the flow chart. Any participant who took the rescue med during the study period (incl. cross-over period) was counted in this analysis. If a participant took the rescue med twice within the same period, the number is counted as one.|||participants|||Number
2751664|NCT00863057|Secondary|Patient and Clinician Global Impression of Change (PGIC and CGIC) on a 7-point Likert Scale|"The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse~Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study."|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||participants|||Number
2751665|NCT00863057|Secondary|Emotional Functioning as Measured by the Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered.|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Standard Deviation|Mean
2751668|NCT00863057|Secondary|Mean Nighttime Pain Measure on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time."|Over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Standard Error|Mean
2751669|NCT00863057|Secondary|Number of Participants With 50% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||participants|||Number
2751670|NCT00863057|Secondary|Number of Participants With 30% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||participants|||Number
2751671|NCT00863057|Primary|Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours."|During the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Standard Deviation|Mean
2751672|NCT00862979|Secondary|Reciprocal Creatinine Slope Between Month 6 and Month 18|Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.|Between Month 6 and Month 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||1/(μmol/L)/(hour)||Standard Deviation|Mean
2751673|NCT00862979|Secondary|Serum Creatinine at Month 6, 8, 9, 10 12 and 18|Serum Creatinine is an indicator of renal function measured in the blood|Month 6, 8, 9, 10 12 and 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||μmol/L||Standard Deviation|Mean
2751674|NCT00862979|Secondary|Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18|Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)|Month 12 and 18|Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 12 & 18 were analyzed|||mL/min||Standard Deviation|Mean
2751675|NCT00862979|Secondary|Occurrence of Major Cardiac Events (MACE) From Month 6 to 18|Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting|Month 6 to Month 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||Occurences|||Number
2751676|NCT00862979|Secondary|Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18|Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.|Month 6 to Month 9; Month 9 to Month 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||Occurences|||Number
2751677|NCT00862979|Primary|Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18|Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3*(C-1.154)*(A-0.203)*G*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.|Month 18|Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 18 were analyzed|||mL/min||Standard Deviation|Mean
2751678|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. MMSE: Brief, structured examination of mental status that assesses orientation, memory, attention, naming, comprehension, and praxis. The range is 0 to 30, with a lower score indicating a worse mental state|Baseline to 1 year|FAS, OC|||Scale scores||Standard Error|Least Squares Mean
2751679|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. COWAT: Verbal fluency test. The patient was asked to, during 1 minute, generate as many words as possible beginning with three pre-specified letters. The total score was calculated as the sum of acceptable words generated, with higher scores indicating lower cognitive impairment|Baseline to 1 year|FAS, observed cases (OC)|||Scale scores||Standard Error|Least Squares Mean
2751681|NCT00862940|Primary|Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)|Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)|Baseline to 1 year|FAS-MRI: Full-analysis set for all patients in the all-patients-treated set (APTS) who had at least one valid MRI scan >=6 months after initiation of investigational medicinal product (IMP). The FAS (full analysis set, efficacy set) replaces the intention-to-treat (ITT) concept used in older terminology.|||mL/year||Standard Error|Mean
2751682|NCT00862849|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug|The number of TEAEs related to study drug (as determined by the Investigator) are summarized. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|first dose through 7 to 10 days after last dose|Participants who received at least one dose of study drug (insulin lispro, regular human insulin, or recombinant human hyaluronidase [rHuPH20]).|||events|||Number
2751683|NCT00862849|Secondary|Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and every 30 mins (from 90 to 240 mins) after each injection. Percentage of total glucose infused from 0 to 4 hours is summarized.|predose up to 240 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.|||percentage of total glucose infused||Standard Deviation|Mean
2751684|NCT00862849|Secondary|Time to Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. Time to 25%, 50%, and 75% of total glucose infused are summarized.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.|||minutes||Standard Deviation|Mean
2751685|NCT00862849|Secondary|Peak Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable Cmax data.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
2751686|NCT00862849|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable t(50%max) data.|||minutes||Standard Deviation|Mean
2751687|NCT00862849|Primary|Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.|predose up to 30 minutes postdose|Participants who completed all study visits and had evaluable %AUC(0-t) data.|||percentage of coefficient of variance||Standard Deviation|Mean
2751688|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.|Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
2751689|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.|Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
2751690|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.|Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
2751691|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.|Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
2751692|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.|Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
2751693|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).|Median overall survival (OS)|From date of registration (Informed Consent Form completed) until the date of death.||||Months||95% Confidence Interval|Median
2751694|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).|Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.|From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.||||Months||95% Confidence Interval|Median
2751695|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).|Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
2751696|NCT00862823|Primary|Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz|The maximum concentration for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2751697|NCT00862823|Primary|Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz|The area under the concentration time curve for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.|||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2751698|NCT00862810|Primary|Pain Following HPV Vaccine|"Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.~The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain."|10 minutes following vaccination||||participants|||Number
2751699|NCT00862784|Secondary|Serum Anti-IMC-1121B (Immunogenicity) at Day 1|Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.|Day 1 (Cycles 1, 5, 9, and 30-day follow-up)|All participants who received any amount of study drug and had serum Anti-IMC-1121B (ramucirumab) evaluated.|||participants|||Number
2751700|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751701|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751702|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751703|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751704|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751705|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751706|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751707|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751708|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751709|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
2751710|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)|Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received any amount of study drug.|||participants|||Number
2751711|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received at any amount of study drug.|||participants|||Number
2751712|NCT00862784|Secondary|Duration of Response|The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.|Time of response to time of measured progressive disease up to 22.2 months|All participants who received any amount of study drug who had CR and PR.|||months||95% Confidence Interval|Median
2751713|NCT00862784|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 18.|||months||95% Confidence Interval|Median
2751714|NCT00862784|Secondary|Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]|ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease up to 23.8 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2751715|NCT00862784|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 11.|||months||95% Confidence Interval|Median
2751716|NCT00862745|Primary|Change in Frequency of Urge Urinary Incontinence Episodes at Week 12.||Baseline and Week 12|The population analyzed included all participants receiving at least 1 dose of study intervention.|||episodes||Standard Deviation|Mean
2751717|NCT00862719|Secondary|Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity|Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.|Transplant (Day 0) up to 3 years|All patients enrolled and received treatment.|||participants|||Number
2751718|NCT00862719|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets.|||days||95% Confidence Interval|Median
2751719|NCT00862719|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment.|||days||95% Confidence Interval|Median
2751720|NCT00862719|Primary|Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant|Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.|Transplant (Day 0) through Day +30|Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only|||percentage of participants||95% Confidence Interval|Number
2751721|NCT00862654|Primary|Total Severity Score (TSS): Percent Change From Baseline at Week 4|Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.|baseline and week 4|Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)|||Percent change||Full Range|Median
2751722|NCT00862641|Secondary|Percentage of Selected Respiratory Adverse Events|"The selected respiratory Adverse Events are dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea and wheezing.~Subjects may have reported more than one type of Adverse Event."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Percentage of Subjects|||Number
2751723|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry|Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.|||Percentage of Oxygen Saturation||Standard Deviation|Mean
2751724|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio|"FEV1 and FVC data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|"The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as N."|||Percentage of FEV1 / FVC||Standard Deviation|Mean
2751725|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)|"FVC data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.|||Liters||Standard Deviation|Mean
2751726|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted|"FEV1 data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.|||Percentage of Predicted FEV1||Standard Deviation|Mean
2751727|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values|"FEV1 data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each time point is noted in the category titles, as “N”.|||Liters||Standard Deviation|Mean
2751728|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).~Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.~The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Subjects|||Number
2751729|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).~Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.~The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 2 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Subjects|||Number
2751730|NCT00862641|Primary|Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment|FEV1 data was obtained by spirometry measures.|2 Hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Percentage of Subjects|||Number
2751731|NCT00862563|Secondary|Wechsler Memory Scale-3rd Ed. Spatial Span|WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||units on a scale||Standard Error|Mean
2751732|NCT00862563|Secondary|Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total|WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||units on a scale||Standard Error|Mean
2751733|NCT00862563|Secondary|COWAT-Category|Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced.|Baseline, Week12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||Number of Words Produced||Standard Error|Mean
2751734|NCT00862563|Secondary|Controlled Word Association Test (COWAT)- Letter Fluency|Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown.|Baseline & Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||Number of Words Produced||Standard Error|Mean
2751735|NCT00862563|Secondary|Percent Days Drinking|Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.|||Percentage of Days/ Week||Standard Error|Mean
2751736|NCT00862563|Secondary|Mean Percent Days Heavy Drinking|Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the time frame for the specific analyses, i.e. Weeks 10,11,12.|||Percentage of Days/Week||Standard Error|Mean
2751737|NCT00862563|Secondary|AB-Neurotoxicity Scale.|Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|Week 12|Alcohol dependent subjects.|||Scale Scores||Standard Error|Mean
2751738|NCT00862563|Primary|The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties.|Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.|||Standard Drinks per day||Standard Error|Mean
2751739|NCT00862537|Primary|Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months|The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).|baseline and 11 months||||scores on a scale||Standard Deviation|Mean
2751740|NCT00862459|Secondary|Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter|CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding subjects who had no lesion detected, and those who had no value determined)|||CNR||Standard Deviation|Mean
2751741|NCT00862459|Secondary|Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group|The blinded readers gave an estimation of the tumor grade of brain tumors (low grade [I or II] or high grade [III or IV]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results|up to 2 hours after the injection of study medication|PPS participants with tumors|||Percentage of accuracy|||Number
2751742|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader|The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751743|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader|The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751744|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader|The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751745|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader|The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751746|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader|The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751747|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader|The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751748|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist|The independent radiologist determined the PF for each lesion|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||seconds||Standard Deviation|Mean
2751749|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist|The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||seconds||Standard Deviation|Mean
2751750|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist|The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||seconds||Standard Deviation|Mean
2751751|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist|The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||mL / 100 g tissue / min.||Standard Deviation|Mean
2751752|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist|The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||mL / 100 g tissue||Standard Deviation|Mean
2751983|NCT00860314|Secondary|Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position|Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.|30 seconds after cardioversion||||participants|||Number
2751753|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist|The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||mL / 100 g tissue||Standard Deviation|Mean
2751754|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751755|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751756|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751757|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751758|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751759|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751760|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
2751761|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751762|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751763|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751764|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751765|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751766|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751767|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751768|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751769|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751770|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751771|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751772|NCT00862459|Secondary|Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI|The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
2751984|NCT00860314|Secondary|Mean Energy Requirement for Successful Cardioversion|Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.|30 seconds after cardioversion||||Joules||Standard Deviation|Mean
2751774|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS(excluding subjects with no enhanced lesion detected)|||percentage of lesions|||Number
2751775|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)|||percentage of lesions|||Number
2751776|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)|||percentage of lesions|||Number
2751777|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||percentage of lesions|||Number
2751778|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||percentage of lesions|||Number
2751779|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||percentage of lesions|||Number
2751780|NCT00862459|Primary|Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI|CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding participants with insufficient images)|||CNR||Standard Deviation|Mean
2751781|NCT00862459|Primary|Assessment of Internal Morphology|The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||scores on a scale||Standard Deviation|Mean
2751782|NCT00862459|Primary|Assessment of Border Delineation|The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||scores on a scale||Standard Deviation|Mean
2751783|NCT00862459|Primary|Assessment of Lesion Contrast Enhancement|The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||scores on a scale||Standard Deviation|Mean
2751784|NCT00862459|Primary|Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.|Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.|up to 2 hours after the injection of study medication|PPS (excluding one participant with insufficient images)|||Lesions per participant||Standard Deviation|Mean
2751785|NCT00862459|Primary|Categorical Visualization Score (CVS)|The primary visualization variables (number [no.] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.|up to 2 hours after the injection of study medication|The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)|||Scores on a scale||Standard Deviation|Mean
2751786|NCT00862277|Primary|Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2751787|NCT00862277|Primary|Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
2751788|NCT00862251|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751789|NCT00862251|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751790|NCT00862251|Secondary|Percent Change From Baseline Apolipoprotein A-I (Apo A-I)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751791|NCT00862251|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751792|NCT00862251|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2751793|NCT00862251|Secondary|Percent Change From Baseline in TC/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751794|NCT00862251|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751795|NCT00862251|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751796|NCT00862251|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2751797|NCT00862251|Secondary|Percent Change From Baseline in Triglycerides||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751798|NCT00862251|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent Change||95% Confidence Interval|Least Squares Mean
2751799|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg|||participants|||Number
2751800|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg|||participants|||Number
2751801|NCT00862251|Secondary|Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||participants|||Number
2751802|NCT00862251|Secondary|Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin||Baseline and Week 6|Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2751803|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg|||Percent change||95% Confidence Interval|Least Squares Mean
2751804|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg|||Percent change||95% Confidence Interval|Least Squares Mean
2751805|NCT00862251|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2752011|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 1|Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg|week 1|Full analysis set, imputation method used was last observation carried forward (LOCF).|||participants|||Number
2751806|NCT00862186|Primary|Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness.|The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from '1 - not at all' to '5 - all the time' the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point.|baseline and weekly up to 8 weeks||||units on a scale||Full Range|Median
2751807|NCT00862134|Secondary|Positive Aldo-keto Reductase 1C3 (AKR1C3) Expression in Participating Patients|"AKR1C3 was evaluated on a semi-quantitative scale, and the percentage of cells staining at each of the following four levels was recorded: 0 (unstained), 1+ (weak staining), 2+ (moderate staining) and 3+ (strong staining).~Patients with a strong staining score (3+) were considered to be AKR1C3 positive"|Within 1 year of enrollment||||participants|||Number
2751808|NCT00862134|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following last administration of study treatment||||participants|||Number
2751809|NCT00862134|Primary|Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone|Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria|Participants were followed for the duration on study, an average of 4 months||||participants|||Number
2751810|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance|A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.|At Week 10, end of treatment|Safety Analysis Set (OC). Descriptive statistics only.|||mL/min||Standard Deviation|Mean
2751811|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)|The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.|||WPAI_CD Item 5 score||Standard Deviation|Mean
2751812|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score|The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL).|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.|||IBDQ score||Standard Deviation|Mean
2751813|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)|Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.|||mg/L||Standard Deviation|Mean
2751814|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Fecal Calprotectin|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.|At Week 10, end of treatment|Full Analysis Set (FAS), observed cases (OC), descriptive statistics only.|||microgram/gram faeces||Standard Deviation|Mean
2751815|NCT00862121|Primary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.|The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70.|At Week 10, end of treatment|The percentage of CDAI responders at Week 10 was analysed for the FAS (treated participants with post-baseline CDAI), Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
2751816|NCT00862082|Secondary|Pharmacokinetics (AUC) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng.h/ml||Standard Deviation|Mean
2751817|NCT00862082|Secondary|Pharmacokinetics (T1/2) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||hr||Standard Deviation|Mean
2751818|NCT00862082|Secondary|Pharmacokinetics (Cmax) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng/ml||Standard Deviation|Mean
2751819|NCT00862082|Secondary|Pharmacokinetics [Area Under the Curve(AUC)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng.h/ml||Standard Deviation|Mean
2751820|NCT00862082|Secondary|Pharmacokinetics [Half Life (T1/2)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||hr||Standard Deviation|Mean
2751821|NCT00862082|Secondary|Pharmacokinetics [Maximum Plasma Concentration (Cmax)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in pharmacokinetic (PK) sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng/ml||Standard Deviation|Mean
2751822|NCT00862082|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment||||participants|||Number
2751823|NCT00862082|Primary|Maximum Tolerated Dose (MTD) of PR104 When Used in Combination With Standard Dose Sorafenib in the Phase I Population||4 weeks (1 cycle)||||mg/m2|||Number
2751985|NCT00860314|Primary|Number of Successfully Cardioverted Participants for Each Electrode Position|After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.|30 seconds after cardioversion||||participants|||Number
2751824|NCT00861913|Secondary|Duration of Response|The date at which the objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented, assessed up to 5 years.|From time of documented response to the date progression is documented, assessed up to 5 years.|There was one response and therefore median duration of response was not analyzed.||||||
2751825|NCT00861913|Secondary|Progression Free Survival|Progression free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 5 years||||months||95% Confidence Interval|Median
2751826|NCT00861913|Secondary|Overall Survival|Overall survival time is defined as the time from registration to the time of death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2751827|NCT00861913|Primary|Toxicity|Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.|Up to 5 years||||participants|||Number
2751828|NCT00861913|Primary|Tumor Response Rate|"Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 5 years||||percentage of patients||90% Confidence Interval|Number
2751829|NCT00861757|Secondary|Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||beats per minute (bpm)||Standard Deviation|Mean
2751830|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Standing) at 12 Weeks||baseline, 12 weeks|All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication.|||mm Hg||Standard Deviation|Mean
2751831|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Sitting) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||mm Hg||Standard Deviation|Mean
2751832|NCT00861757|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||milliliter (mL)||Standard Deviation|Mean
2751833|NCT00861757|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks|Nanograms of PSA per milliliter (ng/mL) of blood.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||microgram/Liter||Standard Deviation|Mean
2751834|NCT00861757|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12|The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||participants|||Number
2751835|NCT00861757|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12|The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||Participants|||Number
2751836|NCT00861757|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks|"Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||milliliter per second (mL/sec)||Standard Error|Least Squares Mean
2751837|NCT00861757|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||units on a scale||Standard Error|Least Squares Mean
2751986|NCT00860314|Secondary|Mean Number of Cardioversion Shocks||30 seconds after cardioversion||||Shocks||Standard Deviation|Mean
2751838|NCT00861757|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks|"Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||units on a scale||Standard Error|Least Squares Mean
2751839|NCT00861757|Secondary|Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||units on a scale||Standard Error|Least Squares Mean
2751840|NCT00861757|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|"The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.~Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||Units on a scale||Standard Error|Least Squares Mean
2751841|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751842|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (PPD ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||EU/mL||95% Confidence Interval|Geometric Mean
2751843|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751844|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||EU/mL||95% Confidence Interval|Geometric Mean
2751845|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751846|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody concentrations are expressed as Geometric Mean Titer (GMT).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Titer||95% Confidence Interval|Geometric Mean
2751847|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751873|NCT00861744|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
2751848|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody titers were expressed as Geometric Mean Titer (GMT).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Titer||95% Confidence Interval|Geometric Mean
2751849|NCT00861744|Secondary|Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.||From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
2751850|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.|From Day 180 to Day 730 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
2751851|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
2751852|NCT00861744|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).|NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
2751853|NCT00861744|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 15-day (Days 0-14) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751854|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.|Swelling with accompanying general symptoms|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751855|NCT00861744|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
2751856|NCT00861744|Secondary|Number of Subjects Reporting Medically Attended Visit (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
2751857|NCT00861744|Secondary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751858|NCT00861744|Secondary|Number of Subjects Reporting Fever.|fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.|During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751859|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||IU/mL||95% Confidence Interval|Geometric Mean
2751860|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||IU/mL||95% Confidence Interval|Geometric Mean
2751987|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 8|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 8|FAS (LOCF)|||participants|||Number
2751861|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751862|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751863|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751864|NCT00861744|Secondary|Number of Subjects Reporting Other Rash.|Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751865|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))|Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Titers||95% Confidence Interval|Geometric Mean
2751866|NCT00861744|Secondary|Number of Subjects Reporting Febrile Convulsions|Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751867|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.||During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
2751868|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751869|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751870|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751871|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
2751872|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 0 before vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||µg/mL||95% Confidence Interval|Geometric Mean
2752033|NCT00860158|Secondary|To Estimate PSA Response Rate||18 months|Data for this secondary objective was not collected or analyzed.||||||
2751874|NCT00861744|Secondary|Anti-hepatitis A Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751875|NCT00861744|Secondary|Anti-varicella Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751876|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 42 after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||µg/mL||95% Confidence Interval|Geometric Mean
2751877|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||IU/mL||95% Confidence Interval|Geometric Mean
2751878|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Titers||95% Confidence Interval|Geometric Mean
2751879|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2751880|NCT00861744|Secondary|Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.|Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
2751881|NCT00861744|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
2751882|NCT00861744|Primary|Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
2751883|NCT00861744|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
2751884|NCT00861705|Secondary|Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.|Assessed by physician observation.|at definitive surgery, up to 28 weeks||||percentage of participants with event||95% Confidence Interval|Number
2751885|NCT00861705|Secondary|Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause|From study entry to first event.|up to 10 years||||Participants|||Count of Participants
2751886|NCT00861705|Secondary|Recurrence-free Survival|From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause. Number of Participants who Died Due to Any Cause or had a recurrence.|up to 10 years||||Participants|||Count of Participants
2751887|NCT00861705|Secondary|Overall Survival|Number of Participants who Died Due to Any Cause|up to 10 years|All treated patients|||Participants|||Count of Participants
2751926|NCT00861601|Secondary|Platelet Counts at Day 22|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.|||10^9/Liter||Full Range|Median
2751888|NCT00861705|Secondary|Clinical Response Assessed by Tumor Measurement|"Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Both target and, in the event of multifocal or multicentric invasive breast cancer, nontarget lesions should be followed clinically and their clinical size recorded at aseline. Measurements thereafter are required at the completion of 12 weeks of paclitaxel or paclitaxel/carboplatin and at the completion of all neoadjuvant chemotherapy. At any time point, these lesions should be categorized regarding whether there is evidence of progression. If yes, the study chair should be notified in order to determine whether the patient should come off protocol treatment. In-situcarcinoma does not represent a non-target lesion and should not be recorded or followed."|Baseline; at completion of neoadjuvant therapy||||Participants|||Count of Participants
2751889|NCT00861705|Secondary|Radiographic Response Assessed by Tumor Measurement|Assessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.|Baseline; at completion of neoadjuvant therapy||||Participants|||Count of Participants
2751890|NCT00861705|Secondary|Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)|Stage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.|at definitive surgery, up to 28 weeks||||participants|||Number
2751891|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3).|At the time of definitive surgical removal, up to 28 weeks||||percentage of participants with pCR||95% Confidence Interval|Number
2751892|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain carboplatin (arms 3&4) versus not (arms 1&2).|At the time of definitive surgical removal, up to 28 weeks||||percentage of participants with pCR||95% Confidence Interval|Number
2751893|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).|||percentage of participants with pCR||95% Confidence Interval|Number
2751894|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3&4) versus not (arms 1&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).|||percentage of participants with pCR||95% Confidence Interval|Number
2751895|NCT00861692|Primary|Number of Patients With Platelet Count Recovery|Platelet increase of ≥ 100G/L or 50%.|Day 3|Data are missing in 3 patients.|||participants|||Number
2751896|NCT00861692|Primary|Number of Patients With Major or Minor Bleeding|"Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial.~Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding."|During and 30 days after argatroban treatment||||participants|||Number
2751897|NCT00861692|Primary|Number of Patients With Unplanned Amputation||During and 30 days after argatroban treatment||||participants|||Number
2751898|NCT00861692|Primary|Number of Patients With Thrombosis (New and Extended)||During and 30 days after argatroban treatment||||participants|||Number
2751899|NCT00861692|Primary|Death Related to Heparin-induced Thrombocytopenia (HIT)||During and 30 days after argatroban treatment||||participants|||Number
2751900|NCT00861692|Primary|All-cause Death||During and 30 days after argatroban treatment||||participants|||Number
2751901|NCT00861692|Primary|Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation||During and 30 days after argatroban treatment||||participants|||Number
2751902|NCT00861614|Secondary|Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
2751903|NCT00861614|Secondary|Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
2751904|NCT00861614|Secondary|Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
2751905|NCT00861614|Secondary|Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
2751906|NCT00861614|Secondary|Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0|"Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve.~Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to 70 days after last dose of study drug|All treated participants receiving Ipilimumab + Radiotherapy|||weeks||Full Range|Median
2751907|NCT00861614|Secondary|Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)|"The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.~Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to time of onset of the imAR of interest|All treated participants receiving Ipilimumab + Radiotherapy|||weeks||Full Range|Median
2751908|NCT00861614|Secondary|Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)|Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.|Day 1 to 70 days after last dose of study drug|All treated participants|||weeks||95% Confidence Interval|Median
2751909|NCT00861614|Secondary|Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)|The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.|Day 1 to 70 days after last dose of study drug|All treated participants|||weeks||95% Confidence Interval|Median
2751910|NCT00861614|Secondary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0."|Randomization to date of death|All treated participants|||participants|||Number
2751911|NCT00861614|Secondary|Duration of Pain Response|The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.|Day of initial pain response to day of completion of pain response or date of death|All pain-evaluable participants with pain response|||months||95% Confidence Interval|Median
2751912|NCT00861614|Secondary|Pain Response|The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.|Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit|All pain-evaluable participants|||percentage of participants||95% Confidence Interval|Number
2751940|NCT00861263|Primary|Number of Patients With Persistent or Recurrent Bleeding|The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.|up to 6 yrs after after the endoscopy||||participants|||Number
2752034|NCT00860158|Secondary|To Estimate Partial Pathologic Responses (pPR)||18 months|||||||
2751913|NCT00861614|Secondary|Progression Free Survival (PFS)|All PFS events were based on investigator's assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.|Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death|All randomized participants|||months||95% Confidence Interval|Median
2751914|NCT00861614|Primary|Overall Survival Rate|The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Date of randomization to date of death|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2751915|NCT00861614|Primary|Overall Survival (OS)|OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.|Date of randomization to date of death|All randomized participants|||months||95% Confidence Interval|Median
2751916|NCT00861601|Secondary|Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. AUC(0-t)=area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration, and AUC(0-24)=area under the concentration-time curve from 0 (pre-dose) to 24 hours.|Day 14, Day 15|PK Parameter Population|||hours * ng/ml||95% Confidence Interval|Geometric Mean
2751917|NCT00861601|Secondary|Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Tmax=maximum drug concentration time.|Day 14, Day 15|PK Parameter Population|||hours||95% Confidence Interval|Geometric Mean
2751918|NCT00861601|Secondary|Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Cmax=maximum drug concentration.|Day 14, Day 15|PK Parameter Population: all participants from whom a PK sample was obtained and analyzed and whose PK parameter data was evaluated. One of the 12 participants took a prohibited medication that might have decreased the absorption of eltrombopag during the treatment period and was hence excluded from the PK Parameter Population.|||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
2751919|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Age|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of participants in each age category are illustrated by the n's in the category titles."|Baseline, Day 15|FAS|||10^9/Liter||Standard Deviation|Mean
2751920|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Sex|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of females and males in each treatment group are illustrated by the n's in the category titles."|Baseline, Day 15|FAS|||10^9/Liter||Standard Deviation|Mean
2751921|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class|Change from Baseline was calculated as the Day 15 value minus the Baseline value. The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study.|Baseline, Day 15|FAS. The number of participants categorized as Class A or Class B is given in the category titles.|||10^9/Liter||Standard Deviation|Mean
2751922|NCT00861601|Secondary|Percentage of Responders on Day 22|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 22 after receiving eltrombopag for an additional week from Day 15, on which his or her platelet count was <80 x 10^9/Liter.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.|||percentage of responders||95% Confidence Interval|Mean
2751923|NCT00861601|Secondary|Percentage of Responders on Day 15|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 15.|Day 15|FAS|||percentage of responders||95% Confidence Interval|Mean
2751924|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw. Change from Baseline was calculated as the value at each visit minus the Baseline value.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Standard Deviation|Mean
2751925|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22. Change from Baseline was calculated as the value at each visit minus the Baseline value.|Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Standard Deviation|Mean
2752035|NCT00860158|Primary|To Estimate the Pathologic Complete Response (pCR) Rate||18 months|No participants were analyzed for pCR due to study termination||||||
2751927|NCT00861601|Secondary|Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Full Range|Median
2751928|NCT00861601|Secondary|Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Full Range|Median
2751929|NCT00861601|Secondary|Percent Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|FAS|||Percent change||95% Confidence Interval|Mean
2751930|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts and Child-Pugh class as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS|||10^9/Liter||95% Confidence Interval|Mean
2751931|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS|||10^9/Liter||95% Confidence Interval|Mean
2751932|NCT00861601|Primary|Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|Full Analysis Set (FAS): all enrolled participants, excluding those who received no doses of eltrombopag during the treatment period, those without a baseline platelet assessment, and those without at least one on-therapy (scheduled or unscheduled) platelet assessment.|||10^9/Liter||95% Confidence Interval|Mean
2751933|NCT00861471|Secondary|Median Overall Survival Time|Overall survival time is the time from the start of therapy till death. Median overall survival reported here is the time when 50% of the participants are alive.|up to 4 years|Based on intent-to-treat population|||months||95% Confidence Interval|Median
2751934|NCT00861471|Secondary|Time to PSA Progression|Time to PSA pregression is defined as the time at which therapy statred and ends when the PSA increased by 50% above the nadir confirmed on a second determination.|up to 2 years|Based on intent-to-treat population|||days||95% Confidence Interval|Mean
2751935|NCT00861471|Secondary|Percentage of Participants With Measurable Disease Response|Measurable disease response is defined as the number of participants whose best response is complete response or partial response over the number of patients with measurable desease according to the Response Evaluation Criteria in Solid Tumors (RECIST).|up to 2 years|Based on the participants with measurable disease|||percentage of participants|||Number
2751936|NCT00861471|Secondary|Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression|PSA was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population|||percentage of participants|||Number
2751937|NCT00861471|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population.|||percentage of participants|||Number
2751938|NCT00861341|Primary|Percent Platelet Aggregation Induced by Collagen|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using collagen (2ug.mL). At each time point the results are shown for maximum percent aggregation with collagen for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6-9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|baseline and day 6-9||||maximum percentage aggregation||Standard Deviation|Mean
2751939|NCT00861341|Primary|Percent Platelet Aggregation Induced by Arachidonic Acid|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using arachidonic acid (0.5 mM). At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6-9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|at baseline and days 6-9|Analysis population determined per protocol.|||maximum percentage aggregation||Standard Deviation|Mean
2751941|NCT00861198|Primary|Successful Procedure Completion|Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.|baseline||||participants|||Number
2751942|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|2 weeks||||participants|||Number
2751943|NCT00861146|Secondary|Proportion of Days Heavy Drinking|Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.|follow-up weeks 9-12||||proportion of days||Standard Deviation|Mean
2751944|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|12 weeks||||participants|||Number
2751945|NCT00860951|Primary|Accuracy of Typing With BCI Keyboard.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.~Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|mean score from 3 sessions over 29 days||||percentage accuracy||Full Range|Mean
2751946|NCT00860938|Secondary|Change in logRDR Mannitol||12 weeks||||%/mg||Standard Deviation|Mean
2751947|NCT00860938|Secondary|Change in Quality of Life|"St. George Respiratory Questionnaire (SGRQ). Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.~Scores are calculated for three domains: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. Unit of Measure = Units on a scale A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.~Based on empirical data and interviews with patients, a mean change score of 4 units is associated with slightly efficacious treatment, 8 units for moderately efficacious change and 12 units for very efficacious treatment. The higher the change in units, the better the treatment."|12 weeks, baseline to 3 months follow-up||||units||Standard Deviation|Mean
2751948|NCT00860938|Secondary|The Proportion Who Complete Follow-up Without Developing an Exacerbation||12 weeks||||number of participants|||Number
2751949|NCT00860938|Primary|Change in Lung Function (FEV1)||12 weeks|per protocol|||litres||Standard Deviation|Mean
2751950|NCT00860847|Secondary|1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH||1 year|||||||
2751951|NCT00860847|Primary|Rate of Change in Total Coronary Calcium Scores by Computed Tomography|progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.|1 year|all participants were analyzed|||Agatston score change||Standard Deviation|Mean
2751952|NCT00860795|Secondary|Maximal Levels of Interleukin 12 (pg/ml)|interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat|||interleukin 12 level (pg/ml)||Standard Deviation|Mean
2751953|NCT00860795|Secondary|Maximal Levels of Interleukin 6 (pg/ml)|interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat|||interleukin 6 level (pg/ml)||Standard Deviation|Mean
2751954|NCT00860795|Secondary|Maximal Levels of Interleukin 2 (pg/ml)|interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|intention to treat|||interleukin 2 level (pg/ml)||Standard Deviation|Mean
2751955|NCT00860795|Secondary|Adverse Effects||30 days|intention to treat|||participants|participants||Number
2751956|NCT00860795|Secondary|Maximal CD25/69 Activation (% of NK CD25/69+ Cells)|NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation|10 days|intention to treat|||(% of NK CD25/69+ cells)||Standard Deviation|Mean
2751957|NCT00860795|Secondary|Maximal Levels of Interferon Alpha (pg/ml)|interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat|||interferon alpha level (pg/ml)||Standard Deviation|Mean
2751958|NCT00860795|Primary|Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)|tumor necrosis factor alpha NK cells and evidence of CD25/69 activation|10 days|Intention to treat|||tumor necrosis alpha level (pg/ml)||Standard Deviation|Mean
2751980|NCT00860405|Secondary|Fluid Input|Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation|||ml/kg||Standard Deviation|Mean
2751981|NCT00860405|Secondary|Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation|||mm Hg||Standard Deviation|Mean
2751959|NCT00860743|Primary|Heart Rate Variability (Aim 2)|Heart rate variability (HRV) was measured before and after exposure to intermittent hypoxia following administration of a placebo or antioxidant cocktail. Heart rate variability refers to beat-to-beat alterations in heart rate. Under resting conditions, the electrocardiogram of healthy individuals reveals periodic variation in R-R intervals. To measure HRV, R-R interval data are presented in a graph, in which the y-axis plots the R-R intervals (ms2), and the x-axis the total number of beats. Spectral analysis of the graph transforms the signal from time to frequency on the x-axis (Hz), by representing the signal as a combination of sine and cosine waves, with different amplitudes and frequencies. The approach uses Fourier transforms. The heart rate spectrum contains a high frequency (0.15-0.4 Hz) component, which is synchronous with respiration and a low frequency (0.04 to 0.15 Hz) component that appears to be mediated by both the vagus and cardiac sympathetic nerves.|Within the same experimental session|Measurements were made before and after intermittent hypoxia following administration of a placebo or antioxidant cocktail. Please note that analysis of the heart rate variability measures for the healthy group have not been completed to date.|||ms2/Hz||Standard Error|Mean
2751960|NCT00860743|Primary|Ventilation (Aim 1)|Ventilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.|Within the same experimental session||||fraction of baseline||Standard Error|Mean
2751961|NCT00860535|Primary|Growth Factor Signature (GFS) Change From Baseline Measured by Time Weighted Average (TWA) for Days 1 to 22|"The GFS was measured by microarray analysis using the entire 101 gene signature.~The TWA is the area under the curve (AUC) divided by the time interval (for this study it was the AUC of gene-expression divided by Days 1 to 22).~Participants with blast phase Ph+ CML or Ph+ ALL were measured for change in the GFS post-treatment when treated with imatinib, dasatinib, or nilotinib, using Microarray. Change was represented as the GFS Fold Ratio of TWA for Days 1 to 22 to Baseline."|Baseline to 22 Days After Initiation of Therapy||||GFS Fold Ratio-TWA[Days1-22] to baseline||90% Confidence Interval|Mean
2751962|NCT00860535|Primary|Growth Factor Signature (GFS) Variability at Baseline|"The GFS was measured by microarray analysis using the entire 101 gene signature. The GFS is quantified as the change in gene expression between two separate samples collected from the same patient. The signature has 101 genes in two oppositely regulated arms, which are pre-specified. The expression of genes in the UP arm goes up with increasing pathway activity, and the expression of genes in the DOWN arm goes down with increasing pathway activity.~The GFS variability was represented by the GFS change between two baseline samples (Mean GFS Fold Ratio [Screening to Day 1 Predose])."|Screening to Day 1 Predose|Participants whose GFS was measured using microarrays to determine the pretreatment baseline variability in participants with blast phase Ph+ CML or Ph+ ALL.|||GFS Fold Ratio-Screening to Day1 Predose||90% Confidence Interval|Mean
2751963|NCT00860470|Secondary|Small for Gestation Age|Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).|December 2014||||participants|||Number
2751964|NCT00860470|Secondary|Low Birth Weight|Birth weight below 2500g|December 2014||||participants|||Number
2751965|NCT00860470|Secondary|Moderate to Late Preterm|Risk of birth between 32 and 37 weeks gestation|December 2014||||participants|||Number
2751966|NCT00860470|Secondary|Very Pre-term|Risk of birth between 28 and 32 weeks of gestation|December 2014||||participants|||Number
2751967|NCT00860470|Secondary|Extremely Pre-term|Risk of birth before 28 weeks gestation|December 2014||||participants|||Number
2751968|NCT00860470|Secondary|Preterm Birth|Risk of being born before 37 weeks of gestation|December 2014||||participants|||Number
2751969|NCT00860470|Secondary|Still Birth Rates|Risk of Still birth|December 2014||||participants|||Number
2751970|NCT00860470|Secondary|Post-neonatal Mortality|Risk of Post-neonatal Mortality (29th -180th day of life)|Dec 2014||||participants|||Number
2751971|NCT00860470|Secondary|Neonatal Mortality|Risk of neonatal Mortality (28 days of life)|Dec 2014||||participants|||Number
2751972|NCT00860470|Primary|Infant Mortality Through 6 mo of Age|Risk of Infant Mortality to Age 6 months (180 days)|Dec 2014||||participants|||Number
2751973|NCT00860457|Primary|Complete Response Rate|Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.|3 years||||percentage of patients|||Number
2751974|NCT00860405|Other Pre-specified|Acute Renal Failure (ARF)|Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.|From baseline until 2nd postop morning.|Safety Population (SAF) = All randomized patients treated with study drug.|||Participants|||Number
2751975|NCT00860405|Other Pre-specified|Mortality|Mortality was reported for the time period from screening until the end of follow-up.|From screening to end of follow-up|Safety Population (SAF) = All randomized patients treated with study drug|||Participants|||Number
2751976|NCT00860405|Other Pre-specified|Length of Stay on the Intensive Care Unit (ICU)|Length of stay (number of days) on the intensive care unit (ICU).|From admission to ICU until discharge from ICU|Safety Population (SAF) = All randomized patients treated with study drug.|||Days||Inter-Quartile Range|Median
2751977|NCT00860405|Other Pre-specified|Calculated Perioperative Red Blood Cell (RBC) Loss|"Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit [baseline] - hematocrit [2nd postop morning]) + transfused RBC volume2;~Predicted blood volume (mL) = 80 × body weight (kg)~Transfused RBC volume = 0.7 × infused packed RBC"|2 days|Safety Population (SAF) = All randomized patients treated with study drug.|||ml/kg||Standard Deviation|Mean
2751978|NCT00860405|Secondary|Fluid Balance|Balance of total fluid input and total fluid output|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.|||ml/kg||Standard Deviation|Mean
2751979|NCT00860405|Secondary|Fluid Output|Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.|||ml/kg||Standard Deviation|Mean
2752012|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in DBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752013|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in DBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752014|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in DBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752015|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in DBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752016|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8|Overall mean reduction from a common mean baseline in DBP|baseline and week 8|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752017|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in SBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752018|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in SBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752019|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in SBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752020|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in SBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752021|NCT00860262|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8|Overall mean reduction from a common mean baseline in SBP|baseline and week 8|Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2752022|NCT00860249|Primary|Completion of CRC Screening|What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months from initial contact|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.|||participants|||Number
2752023|NCT00860249|Secondary|The Secondary Outcome for the Study is the Time to Screening Completion.|This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months after randomization|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.|||participants|||Number
2752024|NCT00860171|Secondary|Relapse Rate|Number of relapse|Up to 6 years||||Participants|||Count of Participants
2752025|NCT00860171|Secondary|Progression-free Survival|number of people with progression free survival|Up to 6 years||||Participants|||Count of Participants
2752026|NCT00860171|Secondary|Overall Survival||Up to 6 years||||days||Standard Deviation|Mean
2752027|NCT00860171|Secondary|Adverse Events|Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.|Up to 6 years||||number of adverse events|||Number
2752028|NCT00860171|Primary|I-131 Activity Administered||At time of I-131 therapy||||mCi I-131||Full Range|Mean
2752029|NCT00860171|Primary|Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant|"Dose escalation/de-escalation will be conducted by the two-stage approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4)."|Within 30 days post-transplant||||Gray of I-131 (absorbed dose that the I|||Number
2752030|NCT00860158|Secondary|To Estimate Safety and Tolerability of LHRH Plus Dasatinib||18 months|||||||
2752031|NCT00860158|Secondary|To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers||18 months|||||||
2752032|NCT00860158|Secondary|To Estimate Progression Free Survival||18 months|||||||
2752036|NCT00860067|Secondary|Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
2752037|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
2752038|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
2752039|NCT00860067|Secondary|The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
2752040|NCT00860067|Secondary|The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14|The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597).|||participants|||Number
2752041|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231).|||participants|||Number
2752042|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249).|||participants|||Number
2752043|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196).|||participants|||Number
2752044|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160).|||participants|||Number
2752045|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66).|||participants|||Number
2752086|NCT00859651|Secondary|Change in Percent Density|Assessed by mammography and breast MRI.|Baseline to 1 year|Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).|||percentage of breast density||Standard Deviation|Mean
2752046|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43).|||participants|||Number
2752047|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).|||participants|||Number
2752048|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429).|||participants|||Number
2752049|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.||Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590).|||participants|||Number
2752050|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231).|||participants|||Number
2752051|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249).|||participants|||Number
2752052|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196).|||participants|||Number
2752053|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160).|||participants|||Number
2752054|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66).|||participants|||Number
2752055|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43).|||participants|||Number
2752056|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).|||participants|||Number
2752057|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429).|||participants|||Number
2752058|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589).|||participants|||Number
2752059|NCT00860067|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589).|||geometric mean titer||Full Range|Geometric Mean
2752060|NCT00860028|Secondary|Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions|Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.|||Number of participants|||Number
2752061|NCT00860028|Primary|Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions|Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.|||percentage of heavy drinking days||Standard Deviation|Mean
2752062|NCT00860028|Primary|Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.|Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.|Last 4 weeks of treatment|All participants were included in the analysis, assuming an intention to treat method.|||Participants|||Number
2752063|NCT00859976|Primary|Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.|34 patient cases without duplicated data were the basis for the radiographic analysis that was conducted: Bonemaster group, n = 12; Plasma-Sprayed group, n = 22. The degree of osseous-fixation was determined by grading: 1-2 mm radiolucencies, classed as not fixated; >2mm radiolucencies, classed as unstable.|2 years.||||Participants|||Count of Participants
2752064|NCT00859976|Secondary|Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Hip Score, Each question is scored on a scale of 0 (best health state) to 4 (worst health state); total WOMAC hip score, 0 being the best and 96 being the worst.|2 years|2 years post-op|||Units on a Scale||Standard Deviation|Mean
2752065|NCT00859976|Secondary|Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score|Oxford Hip Score, scored 12-60. The Oxford hip score - this score was based on the original publication where each answer gives a score of 1-5. A score of 1 for each question, represented best outcome/least symptoms. Therefore a total score of 12 was the best overall outcome.|2 years.|2 years post-op|||Units on a scale||Standard Deviation|Mean
2752066|NCT00859976|Secondary|Secondary Outcomes Are Functional Assessment Using Harris Hip Score|Modified Harris Hip Score, total score 0-100. A score of <70 is poor, 70-79 is fair, 80-89 is good, 90-100 is excellent.|2 years|2 years post-op|||Units on a scale||Standard Deviation|Least Squares Mean
2752067|NCT00859976|Primary|Record and Measure Bone Density Using DEXA Scans at 24 Months.|DEXA scan cohort - DEXA scan was used to measure bone density. Below is the calculated net average bone mineral density (BMD) percentage change from baseline at 2 years.|2 years.|DEXA scan cohort: Bonemaster group, n = 7; Plasma-Sprayed group, n = 7|||Net average BMD %change from baseline||Standard Deviation|Mean
2752068|NCT00859950|Primary|ODI|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.|Day 1 (all subjects)||||events/hour||Standard Deviation|Mean
2752069|NCT00859937|Secondary|Changes in Laboratory Correlates|Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline and 4 weeks|Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.||||||
2752070|NCT00859937|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.|Up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.|||months||90% Confidence Interval|Median
2752071|NCT00859937|Primary|Progression-free Survival|Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.|up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.|||months||90% Confidence Interval|Median
2752072|NCT00859937|Primary|Response Rate|Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 months|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.|||participants|||Number
2752073|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Safety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (>3*ULN); bilirubin (>2*ULN if PreRX <= ULN; >3*ULN if PreRX > ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT >3*ULN and bilirubin >1.5*ULN within 14 days on or after ALT elevation.|Baseline to Week 24/end of treatment plus 30 days||||participants|||Number
2752074|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose <54 (>350) mg/dL; creatine kinase (>5*ULN);calcium <7.5 (>=1 mg/dL from ULN and >= 0.5mg/dL from PreRX); sodium <130 or < 120 male/female (>150 mEq/L; potassium <=2.5 (>=6.0) mEq/L; bicarbonate <= 13 mEq/L; inorganic phosphorus: <=1.8 if age 17-65 or <=2.1 if age >=66, (>=5.6 if age 17-65 or >=5.1) mg/dL if age >=66; albumin <=2 (>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (>1800 mg/g)|Baseline to Week 24/end of treatment plus 4 days|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||participants|||Number
2752075|NCT00859898|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants|12-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included.|Week 24||||participants|||Number
2752076|NCT00859898|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||bpm||Standard Error|Mean
2752077|NCT00859898|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||mmHg||Standard Error|Mean
2752085|NCT00859833|Primary|Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)|The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)|2 hours|Analysis was per protocol. All patients with analyzable data were included. 2/30 patients had technical problems with the MRI data that made their data unable to be analyzed.|||ratio||Standard Deviation|Mean
2752078|NCT00859898|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs except hypoglycemia, which excluded data after rescue.|||participants|||Number
2752079|NCT00859898|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.|||participants|||Number
2752080|NCT00859898|Secondary|The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants|Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg). Body weight measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||kg||Standard Error|Mean
2752081|NCT00859898|Secondary|Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%|HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (>=) 9.0%. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values, whose baseline HbA1c was >=9.0%.|||Percent of Hemoglobin||Standard Error|Mean
2752082|NCT00859898|Secondary|Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values; N=202, 216, 203, respectively. n=number of responders: 92, 69, 72, respectively. n/N=percent. Percent is then adjusted for baseline HbA1c.|||Percent of participants||95% Confidence Interval|Number
2752083|NCT00859898|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants|Data after rescue medication was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
2752084|NCT00859898|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants|Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non-missing baseline and Week 24 (LOCF) values.|||Percent of hemoglobin||Standard Error|Mean
2752098|NCT00859638|Primary|Physical Functioning Inventory (PFI)|The PFI is used to assess physical functioning in older adults. It contains 21 tasks from 4 subscales: activities of daily living, instrumental activities of daily living, mobility, moderate activities. A series of questions is used to determine whether the person experiences difficulty in completing a task, the level of difficulty they experience, and any changes to the method and/or frequency of task performance. The PFI is sensitive to steps in the natural history of functional decline that are often not assessed clinically. Range of scores: 0 (most difficulty); 100 (least difficulty).|4 months||||units on a scale||Standard Deviation|Mean
2752099|NCT00859586|Secondary|Incidence and Severity Induced GvHD, Proportion of DLI Engraftment, Peak Chimerism, Leukemia Response at Days Post DLI, Residual Leukemia Measured by Patient Chimerism, Leukemia Free Survival From Date Relapse, Safety of Mismatched DLI Procedure...||Severity of GvHD.|||||||
2752100|NCT00859586|Primary|Overall Recipient Survival at 6-month Post-relapse of Disease|This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.|6 months post-relapse of disease||||participants|||Number
2752101|NCT00859573|Primary|Mean Treatment Effectiveness Scores|Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.|thrice weekly from week 3 through week 8|Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines.|||scores on a scale||Standard Deviation|Mean
2752102|NCT00859547|Primary|Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher|Grade 0=normal.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
2752103|NCT00859547|Primary|Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher|ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
2752104|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels|ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
2752105|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels|LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
2752106|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts|Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8-10^9/L. Neutrophils: Grade 0=normal; Grade 1=<LLN-1.5x10^9/L; Grade 2=<1.5-1.0x10^9/L|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
2752107|NCT00859547|Secondary|Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody|Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.|At Day 29|Participants who received study drug and had both baseline and on-treatment anti-rThrombin product antibody assessments.|||Participants|||Number
2752108|NCT00859547|Primary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.|Days 1 through 29, continuously|Participants who received treatment with rThrombin.|||Participants|||Number
2752109|NCT00859547|Primary|Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment|Days 1 through 29, continuously|Participants who received treatment with rThrombin.|||Participants|||Number
2752110|NCT00859521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2752111|NCT00859521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2752112|NCT00859521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
2752113|NCT00859508|Secondary|Radiographic Evaluation|"Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)~Adhesion formation~Membrane formation~Abnormal thickening along graft (device implant) site~Brain edema adjacent to graft (device implant) site"|6 months|||||||
2752114|NCT00859508|Secondary|Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)||up to 6 months|||||||
2752115|NCT00859508|Secondary|Wound Healing Assessment||up to 6 months|||||||
2752116|NCT00859508|Secondary|Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)||up to 6 months|||||||
2752117|NCT00859508|Secondary|Modified Rankin Scale (Patient Function Assessment)||up to 6 months|||||||
2752118|NCT00859508|Primary|Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele|The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.|6 months||||participants|||Number
2752119|NCT00859469|Secondary|Progression-free Survival|Time to radiologic disease progression or death|50 months||||months||95% Confidence Interval|Median
2752120|NCT00859469|Secondary|Overall Survival||50 months|ITT|||months||95% Confidence Interval|Median
2752121|NCT00859469|Primary|Best Response|Radiologic response by RECIST criteria will be compared between baseline and at 2 months. Disease assessment: Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Two determinations of stable/no response or better before progression, but not qualifying as CR or PR are required for a best response of stable/no response.|Two months|intention to treat principle|||participants|||Number
2752122|NCT00859456|Primary|Number of Subjects With Stable Disease at First Assessment of Response|CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria|Up to 84 days||||participants|||Number
2752123|NCT00859430|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2752124|NCT00859430|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2752125|NCT00859430|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
2752126|NCT00859339|Secondary|Correlate Biomarker Expression|To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)||||||
2752127|NCT00859339|Secondary|Progression Free Survival||18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)||||||
2752128|NCT00859339|Secondary|Objective Response Rate|To determine the objective response rate for patients with measurable disease according to RECIST.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)||||||
2752129|NCT00859339|Secondary|Safety Profile|Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC|18 months||||participants|||Number
2752130|NCT00859339|Primary|Pathological Complete Response (pCR) Rate.|number of participants with a pCR|18 months|8 participants were evaluable for pCR|||particpants with pCR|||Number
2752131|NCT00859313|Primary|Percent of Patients Without Device Failure|Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.|12 hours||||percent|||Number
2752132|NCT00859222|Other Pre-specified|Overall Survival (OS) [Phase I]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.|All participants who received at least one dose of the study drug were followed for OS.|||months||Full Range|Median
2752133|NCT00859222|Secondary|Overall Survival [Phase II]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.|All participants who received at least one dose of the study drug were followed for OS.|||months||Full Range|Median
2752134|NCT00859222|Other Pre-specified|6-Month Progression-Free Survival (PFS6) [Phase I]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.|||proportion of participants||95% Confidence Interval|Number
2752135|NCT00859222|Other Pre-specified|Progression-Free Survival (PFS) [Phase I]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.|||months||Full Range|Median
2752136|NCT00859222|Secondary|Progression-Free Survival (PFS) [Phase II]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment.|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All PII participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.|||months||Full Range|Median
2752137|NCT00859222|Secondary|Best Radiographic Response|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for response.|||participants|||Number
2752138|NCT00859222|Primary|6-Month Progression-Free Survival (PFS6) [Phase II]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on RANO criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.|||proportion of participants||95% Confidence Interval|Number
2752139|NCT00859222|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as an adverse event that (a) is related to the LBH589 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 30 days of the study treatment, and (c) meets any of the following criteria: grade 3 thrombocytopenia; grade 4 neutropenia lasting 7 days; grade 4 anemia lasting 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5 x10^9/L; a QT interval corrected for heart rate (QTc) of 500-515 msec that did not stabilize to <480 msec after one week; a second occurrence of QTc 500-515 msec; any QTc >515 msec; any deep vein thrombosis (DVT) or pulmonary embolism (PE) while on fully therapeutic anticoagulation therapy; Grade 3 proteinuria lasting 14 days; or any other clinically significant Grade 3 toxicity despite maximal medical therapy lasting 7 days, any Grade 4 toxicity despite maximal medical therapy; or any Grade 3 or 4 toxicity resulting in study drug discontinuation.|Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for DLT.|||participants with DLT|||Number
2752140|NCT00859222|Primary|LBH589 Maximum Tolerated Dose (MTD) [Phase I]|The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.|Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for MTD.|||mg/day orally, 3x per wk, every other wk|||Number
2752141|NCT00859131|Secondary|Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3||One year||||participants|||Number
2752142|NCT00859131|Secondary|Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3||One year||||participants|||Number
2752143|NCT00859131|Secondary|Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.||One year||||participants|||Number
2752144|NCT00859131|Secondary|Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis||one year||||participants|||Number
2752145|NCT00859131|Secondary|Graft Survival at One Year Post-transplant||One year||||participants|||Number
2752146|NCT00859131|Secondary|Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.||One year||||Patients|||Number
2752147|NCT00859131|Primary|Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.||One year||||participants|||Number
2752148|NCT00859053|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).|Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.|Analysis was done in safety population, defined as all the participants who received study medication.|||Participants|||Number
2752149|NCT00859053|Primary|The Apparent Volume of Distribution at Steady State (Vss/F)|Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.|||mL||Geometric Coefficient of Variation|Geometric Mean
2752522|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||participants||Standard Error|Least Squares Mean
2752150|NCT00859053|Primary|Apparent Clearance of Free BMS-790052 (CLu/F)|CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined. Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2752151|NCT00859053|Primary|Apparent Total Body Clearance (CLT/F) of BMS-790052|Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK set population.|||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2752152|NCT00859053|Primary|Terminal Half-life (T-HALF) of BMS-790052|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||hours||Standard Deviation|Mean
2752153|NCT00859053|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||hours||Full Range|Median
2752154|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052|AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
2752155|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052|AUC(0-T) was calculated by the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
2752156|NCT00859053|Primary|Maximum Observed Plasma Concentration (Cmax) of BMS-790052|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2752157|NCT00859040|Secondary|Overall Survival|Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.|34 months||||percentage of participants|||Number
2752158|NCT00859040|Secondary|Median Time to Progression|"Per protocol, the study's secondary objectives are to be evaluated for the estimate of median ... PFS ... at time of interest. At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information."|34 months|"Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up).~[NOTE: The other 2 patients who were treated on study each remain progression-free after > 1000 days.]"|||days||Full Range|Median
2752159|NCT00859040|Secondary|Median Progression-Free Survival||5 years||||weeks||95% Confidence Interval|Median
2752160|NCT00859040|Secondary|Treatment-related Events|All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms|5 years||||events|||Number
2752161|NCT00859040|Secondary|Response Rate|"Number of participants to experience complete or partial response on study treatment.~For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy."|5 years||||participants|||Number
2752162|NCT00859040|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months||||percentage of patients|||Number
2752590|NCT00856856|Other Pre-specified|Mean Flow Area||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752163|NCT00859027|Secondary|Percent Change of Bone Turnover Markers|Bone turnover markers including N‐telopeptide (NTX), serum C‐telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication.|Baseline and 6 months||||Percent Change||Standard Error|Mean
2752164|NCT00859027|Primary|Percent Change in Bone Mineral Density|BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication.|baseline and 6 months||||Percent Change||Standard Error|Mean
2752165|NCT00859014|Secondary|Functional Outcome|Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.|90-days||||units on a scale||Inter-Quartile Range|Median
2752166|NCT00859014|Primary|Study Related Serious Adverse Events (SR-SAE)|"Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - Events"|2 Years||||Events|||Number
2752167|NCT00858988|Primary|Difference in the Urinary L:M Ratio Before and After the Intervention|To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later.|28 days||||Ratio of lactulose-to-mannitol (L:M) exc||Standard Deviation|Mean
2752168|NCT00858962|Primary|Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)|PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.|6-14 days after beginning co-administration of drugs|All subjects who completed study were included in the analysis.|||hr*ng/mL||Standard Deviation|Mean
2752169|NCT00858858|Primary|Protection Against DNA Damage by UDCA|p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly.|After 8 weeks of UDCA treatment|Patients with Barrett's esophagus, only metaplastic epithelium evaluated. No data were collected from squamous epithelium as originally planned because our in vitro studies subsequently showed that DCA exposure did not cause DNA damage in squamous cells and, therefore, oral UDCA treatment would be meaningless for squamous esophagus.|||Relative Densitometry Units||Standard Error|Mean
2752170|NCT00858845|Other Pre-specified|Change in Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.|Baseline, 3 months|One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.|||bursts/min||Standard Error|Mean
2752171|NCT00858845|Secondary|Change in Proportion of Type 1 Fibers|Fibers were typed as I or II according to presence of myosin heavy chain.|Baseline, 3 months|One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.|||percentage of fibers||Standard Error|Mean
2752172|NCT00858845|Primary|Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity||Baseline, 3 months|One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.|||micromole/min/wet weight||Standard Error|Mean
2752173|NCT00858832|Primary|Endometritis Incidence|Number of participants who developed endometritis|One year||||participants|||Number
2752174|NCT00858780|Secondary|Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization|Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.|Randomization (Week 0) up to Week 48|m-ITT analysis set.|||percentage of participants|||Number
2752175|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Full Range|Median
2752176|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2752189|NCT00858780|Secondary|Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||tender joints||Full Range|Median
2752177|NCT00858780|Secondary|Magnetic Resonance Imaging (MRI) Findings at Randomization|MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752178|NCT00858780|Secondary|Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||units on a scale||Full Range|Median
2752179|NCT00858780|Secondary|Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mg/L||Full Range|Median
2752180|NCT00858780|Secondary|Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mm/hour||Full Range|Median
2752181|NCT00858780|Secondary|Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||minutes||Full Range|Median
2752182|NCT00858780|Secondary|Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.|||mm||Standard Error|Least Squares Mean
2752183|NCT00858780|Secondary|Participant Pain Visual Analog Scale (VAS) at Randomization|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0)|m-ITT analysis set.|||mm||Standard Deviation|Mean
2752184|NCT00858780|Secondary|Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|"Participants answered in general how would you rate your health over the last 2-3 weeks? Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad."|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.|||mm||Standard Error|Least Squares Mean
2752185|NCT00858780|Secondary|Participant General Health Visual Analog Scale (VAS) at Randomization|"Participants answered in general how would you rate your health over the last 2-3 weeks? Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad."|Randomization (Week 0)|m-ITT analysis set.|||mm||Standard Deviation|Mean
2752186|NCT00858780|Secondary|Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mm||Full Range|Median
2752187|NCT00858780|Secondary|Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mm||Full Range|Median
2752188|NCT00858780|Secondary|Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||swollen joints||Full Range|Median
2752210|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||1 year|||||||
2752190|NCT00858780|Secondary|Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48|DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and <2.6=remission.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2752191|NCT00858780|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 implied low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and less than (<) 2.6=remission.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752192|NCT00858780|Secondary|Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State|Participants who had DAS28 <=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.|Randomization (Week 0) up to Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of visits||Standard Deviation|Mean
2752193|NCT00858780|Secondary|Percentage of Participants With Remission or Low Disease Activity (LDA)|Participants who had DAS28 less than or equal to (<=) 3.2 were considered in remission or LDA state.|Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time-point for each treatment arm, respectively.|||percentage of participants|||Number
2752194|NCT00858780|Secondary|Time to Treatment Failure (TTF)|TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.|Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)|m-ITT analysis set.|||weeks||95% Confidence Interval|Median
2752195|NCT00858780|Primary|Percentage of Participant Who Were Non-Failures|A participant was considered as non-failure if the calculated DAS28 <=3.2 at all visits or if the calculated DAS28 >3.2, the increase of calculated DAS28 from randomization (Week 0): was <0.6 at all visit or was >=0.6 but <1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.|Week 48|Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.|||percentage of participants|||Number
2752196|NCT00858702|Secondary|Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)|Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.|||Percent of participants|||Number
2752197|NCT00858702|Secondary|Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)|Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.|||Percent of participants|||Number
2752198|NCT00858702|Primary|The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85||Baseline to week 8|Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.|||Percent of participants|||Number
2752199|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||1 year|||||||
2752200|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||8 weeks|||||||
2752201|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||1 year|||||||
2752202|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||8 weeks|||||||
2752203|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||1 year|||||||
2752204|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||8 weeks|||||||
2752205|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||1 year|||||||
2752206|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||8 weeks|||||||
2752207|NCT00858689|Secondary|Stanford Binet 5 (SB5)||1 year|||||||
2752208|NCT00858689|Secondary|Clinical Global Impression Scale||1 year|||||||
2752209|NCT00858689|Secondary|Clinical Global Impression Scale||8 weeks|||||||
2752221|NCT00858689|Primary|Change From Baseline of ABC Irritability Subtest Score at 8 Weeks|The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliability when used by parents and caregivers of individuals with FXS to assess behavior in the CX516 study NCT00054730, and yielded intraclass correlation coefficient (ICC) values of 0.7-0.9.|Baseline and 8 weeks|ABC-I change in subjects completing 8 weeks of minocycline treatment|||units on a scale||Standard Deviation|Mean
2752222|NCT00858637|Secondary|Vital Signs, Adverse Events, and Laboratory Values||throughout study|||||||
2752223|NCT00858637|Secondary|Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)||16 weeks and 20 weeks|||||||
2752224|NCT00858637|Secondary|Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)|Percent Change from Baseline to Week 16 (LOCF)|week16 minus week0|ITT1 population included all subjects who received a randomisation number, took at least 1 dose of study medication and had at least 1 central serum LDL-C value after the start of study medication.|||Percent Change of LDL-cholesterol||Standard Deviation|Mean
2752225|NCT00858637|Primary|Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)|Percent Change from Week 16 to Week 20 (LOCF)|week20 minus week16|ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.|||Percent Change of LDL-cholesterol||Standard Deviation|Mean
2752226|NCT00858507|Primary|Receipt of Primary Care at the VA|The primary aim of this study was to conduct a randomized controlled trial of different interventions aimed at increasing rates of treatment engagement among a community sample of treatment-naive homeless veterans.|within 4 weeks of intervention||||participants|||Number
2752227|NCT00858494|Secondary|Parental Report of an Adverse Event After a Dose of Study Medication|After each dose of study medication parents reported the presence of any adverse events|data collected after doses occurring up to 10 days after index visit|Study logs were returned in 37 of 49 enrolled participants. After each dose of study medication, the participant's parent indicated in the study log whether any adverse events were noted.|||doses|doses||Number
2752228|NCT00858494|Primary|Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.|For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.|up to 10 days from index visit|Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.|||doses|doses||Number
2752229|NCT00858468|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.|Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.|21 days post-vaccination 2|GMTs were assessed on the Per-Protocol Population|||Titers||95% Confidence Interval|Geometric Mean
2752230|NCT00858468|Other Pre-specified|Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).|Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.|21 days post-vaccination 2|Seroconversion analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.|||Percentage of participants|||Number
2752231|NCT00858468|Other Pre-specified|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).|"Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.~Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40"|21 days post-vaccination 2|Seroprotection analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.|||Percentage of participants|||Number
2752232|NCT00858468|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.|Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intend-to-treat population|||Percentage of participants|||Number
2752233|NCT00858442|Secondary|Length of the Graft|Central length measurement graft between the start and the end of the compression|start and end compression||||centimeter|Participants|Inter-Quartile Range|Median
2752234|NCT00858442|Secondary|Width of the Graft|Central width measurement graft between the start and the end of the compression|start and end compression||||centimeter|Participants|Inter-Quartile Range|Median
2752235|NCT00858442|Primary|Median Time Between Surgery Date and Start Date Compression.|Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days|day|A participant may have one, two or three areas grafted|||day|Participants|Full Range|Median
2752236|NCT00858403|Secondary|Correlation Between Mutation and Inhibition and to Disease Control Rate and Response|To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
2752591|NCT00856856|Other Pre-specified|Percent (%) Lumen Area Stenosis||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of Lumen Area Stenosis|Target lesions|Standard Deviation|Mean
2752237|NCT00858403|Secondary|Correlation Between Extent of Inhibition and Concentration of Dasatinib|We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
2752238|NCT00858403|Secondary|Number of Participant Progressors vs. Non-Progressors With Inhibition Response|We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
2752239|NCT00858403|Secondary|Number of Participants With Serious Adverse Events (SAEs)|We evaluated toxicity of dasatinib in this patient population.|1 year, 4 months||||Participants|||Number
2752240|NCT00858403|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.|1 year, 4 months|We were able to assess 4 of the 7 participants at 6 months.|||Participants|||Number
2752241|NCT00858403|Secondary|Number of Participants With Response to Dasatinib|We planned to estimate the single agent response rate to dasatinib in this patient population|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
2752242|NCT00858403|Primary|Number of Participant Progressors vs. Non-progressors With Tumor Response|We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
2752243|NCT00858390|Primary|Primary Outcome Measure is IL-6 Level|Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.|12+/-2 hours||||pg/ml||Standard Deviation|Mean
2752244|NCT00858364|Secondary|Change From Baseline in Hemoglobin to End of Efficacy Treatment Period|Post-baseline hemoglobin values within 28 days after a RBC transfusion were not be used in the calculation of change.|Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|Primary analysis set with available baseline and at least 1 postbaseline value; if the EOETP value was missing, the last available postbaseline value was used.|||g/dL||Standard Deviation|Mean
2752245|NCT00858364|Secondary|Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 1 to End of the Efficacy Treatment Period|Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin ≤ 8.0 g/dL on or after study day 1 until the EOETP, inclusive.|Week 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|Primary analysis set|||percentage of participants|||Number
2752246|NCT00858364|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa|Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline.|Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later. the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|Randomized and consented participants who received at least one dose of study drug and with a postbaseline result.|||Participants|||Count of Participants
2752247|NCT00858364|Secondary|Percentage of Participants With an Objective Tumor Response|Objective response was defined as the incidence of a complete or partial response at any time during the study. Response was determined by the investigator's assessment of the scans using RECIST version 1.0 or 1.1 depending on the timing of enrollment.|Day 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.|The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization.|||percentage of participants|||Number
2752248|NCT00858364|Secondary|Number of Participants With Adverse Events of Special Interest|Adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer to date, included the following categories: antibody-mediated pure red cell aplasia (PRCA), cardiac failure, central nervous system vascular disorders, convulsions, embolic and thrombotic events, hypersensitivity, hypertension, ischemic heart disease, malignancies, and severe cutaneous adverse reactions. Lack of efficacy and medication errors were also evaluated.|From first dose of study drug until 30 days after last dose; the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|All randomized and consented participants who received at least 1 dose of study drug. Four participants in the placebo group received at least 1 dose of darbepoetin alfa during the study and were included in the darbepoetin alfa group for safety analyses.|||Participants|||Count of Participants
2752249|NCT00858364|Secondary|Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 5 to End of the Efficacy Treatment Period|Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin ≤ 8.0 g/dL on or after study day 29 until the EOETP, inclusive.|Week 5 (day 29) to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.|Primary analysis set participants who were on study as of day 29|||percentage of participants|||Number
2752309|NCT00858143|Secondary|Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>|Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
2752250|NCT00858364|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from randomization to the date of radiographic disease progression or death from any cause, whichever event occurred first. Participants without either event were censored on the date of their last disease assessment. Disease progression was based on the investigator's assessment of scans using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or 1.1 depending on the timing of enrollment.|From randomization until disease progression or death; maximum time on follow-up was 87.23 months.|The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization.|||months||95% Confidence Interval|Median
2752251|NCT00858364|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time from randomization to the date of death due to any cause. Participants were censored on the date of last contact (ie, the date the participant was last known to be alive) if they were not known to have died.|From randomization until death or end of study; maximum time on follow-up was 93.6 months.|Primary analysis set (all randomized and consented participants with non-small cell lung cancer who received at least one dose of study drug)|||months||95% Confidence Interval|Median
2752252|NCT00858247|Secondary|Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation|The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/L||Standard Deviation|Mean
2752253|NCT00858247|Secondary|Change in Triglycerides After 12 Weeks of Vitamin D Supplementation|The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
2752254|NCT00858247|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
2752255|NCT00858247|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
2752256|NCT00858247|Secondary|Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation|Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
2752257|NCT00858247|Primary|Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation|"Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia.~From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance."|Baseline, 12 weeks|All subjects had blood drawn but some tests such as insulin could not be done in some cases due to sample issues. This lab test was calculated from other parameters and not drawn per se. If the values obtained did not allow a calculation of the lab test, then the results could not be reported.|||HOMA score||Standard Deviation|Mean
2752258|NCT00858208|Other Pre-specified|Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)|IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.|Baseline and Week 102 or ET|SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point|||millimeters of mercury (mmHg)|Participants|Standard Deviation|Mean
2752259|NCT00858208|Other Pre-specified|Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study|Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).|Baseline through Week 102|SAS|||participants|||Number
2752260|NCT00858208|Other Pre-specified|Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS|||participants|||Number
2752261|NCT00858208|Other Pre-specified|Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS|||participants|||Number
2752262|NCT00858208|Other Pre-specified|Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS|||participants|||Number
2752283|NCT00858143|Secondary|Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752263|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Previous Treatment of AMD|Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants for who data was collected about previous AMD treatment (yes/no); n=number of participants with evaluable data at specified time point|||scores on a scale|Participants|Standard Deviation|Mean
2752264|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage|Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD|||logMAR|Participants|Standard Deviation|Mean
2752265|NCT00858208|Other Pre-specified|Change From Baseline VA at Final Visit by Age Group|Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group|||logMAR|Participants|Standard Deviation|Mean
2752266|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire|||scores on a scale||Standard Deviation|Mean
2752267|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data|||scores on a scale||Standard Deviation|Mean
2752268|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Month 6, 12, 18, and 24|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point|||scores on a scale||Standard Deviation|Mean
2752269|NCT00858208|Secondary|Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)|"VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the Pigment Epithelial Detachment (PED) present box ticked at Baseline Visit."|Baseline, Week 102 or ET|SAS subset of participants with RPED at baseline|||logMAR|Participants|Standard Deviation|Mean
2752270|NCT00858208|Secondary|Change From Baseline VA at Each Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, every 6 weeks up to Week 102|SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point|||logMAR|Participants|Standard Deviation|Mean
2752271|NCT00858208|Primary|Change From Baseline Visual Acuity (VA) at the Final Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, Week 102 or Early Termination (ET)|Safety Analysis Set (SAS) = Full Analysis Set (FAS): Enrolled participants who received at least 1 dose of Pegaptanib; Number of participants analyzed (N)=participants with evaluable data|||logMAR|Participants|Standard Deviation|Mean
2752523|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm||Standard Error|Least Squares Mean
2752272|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129).|||milligram (mg)|||Number
2752273|NCT00858143|Primary|Serious Adverse Events (SAE) and Adverse Events (AE)|Long term safety of Somavert in treatment of patients with acromegaly|Baseline up to 5 years|Safety Population; all patients who received at least one dose of Somavert® during the observation period.|||participants|||Number
2752274|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).|||milligram (mg)|||Number
2752275|NCT00858143|Secondary|Change From Baseline in Ring Size|Change from baseline: ring size at observation minus ring size at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||millimeters||Standard Deviation|Mean
2752276|NCT00858143|Secondary|Change From Baseline for Systolic Blood Pressure (BP)|Change: systolic blood pressure at observation minus systolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||millimeters Mercury (mmHg)||Standard Deviation|Mean
2752277|NCT00858143|Secondary|Change From Baseline for Diastolic Blood Pressure (BP)|Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||millimeters per mercury (mmHg)||Standard Deviation|Mean
2752278|NCT00858143|Secondary|Mean Change From Baseline for Body Weight|Change: body weight at observation minus body weight at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||kilogram (kg)||Standard Deviation|Mean
2752279|NCT00858143|Secondary|Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752280|NCT00858143|Secondary|Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752281|NCT00858143|Secondary|Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752282|NCT00858143|Secondary|Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2755798|NCT00836355|Secondary|Modified Rankin Scale Score||Baseline, and approximately one week and 3 months later|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.||||||
2752284|NCT00858143|Secondary|Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752285|NCT00858143|Secondary|Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752286|NCT00858143|Secondary|Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
2752287|NCT00858143|Secondary|Glucose Values Above Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752288|NCT00858143|Secondary|Glucose Values Within Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752289|NCT00858143|Secondary|Absolute Glucose Values in Diabetic Patients (Fasting)|Absolute Glucose Values in Patients with Diabetes (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
2752290|NCT00858143|Secondary|Glucose Change From Baseline in Diabetic Patients (Fasting)|Change: glucose at observation minus glucose at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||95% Confidence Interval|Mean
2752291|NCT00858143|Secondary|HbA 1c Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
2752292|NCT00858143|Secondary|HbA 1c Values Below Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Below Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
2752293|NCT00858143|Secondary|HbA 1c Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Within Normal Range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752294|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||95% Confidence Interval|Mean
2752295|NCT00858143|Secondary|Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||Standard Deviation|Mean
2752524|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||kg||Standard Error|Least Squares Mean
2752296|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752297|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752298|NCT00858143|Secondary|Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||Standard Deviation|Mean
2752299|NCT00858143|Secondary|Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||95% Confidence Interval|Mean
2752300|NCT00858143|Secondary|Absolute Hemoglobin A 1c (HbA 1c) Values|Absolute value Hemoglobin A 1c (HbA 1c)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||Standard Deviation|Mean
2752301|NCT00858143|Secondary|Absolute Glucose Values (2h oGTT)|Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
2752302|NCT00858143|Secondary|Absolute Glucose Values (Fasting)|Absolute Glucose values (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
2752303|NCT00858143|Secondary|IGF-I Absolute Values|IGF-I absolute values (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||Standard Deviation|Mean
2752304|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range|Number of participants with glucose values (2h oGTT) above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752305|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range|Number of participants with glucose values (2h oGTT) within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752306|NCT00858143|Secondary|Glucose Values Above Normal Range (Fasting)|Number of participants with glucose values above normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752307|NCT00858143|Secondary|Glucose Values Below Normal Range (Fasting)|Number of participants with glucose values below normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752308|NCT00858143|Secondary|Glucose Values Within Normal Range (Fasting)|Number of participants who have glucose values within normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752592|NCT00856856|Other Pre-specified|Mean Strut Core Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752310|NCT00858143|Secondary|Change From Baseline Glucose (Fasting)|Change: glucose at observation minus glucose at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
2752311|NCT00858143|Secondary|HbA 1c Values Above Normal Range|Number of participants with HbA 1c values above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752312|NCT00858143|Secondary|HbA 1c Values Below Normal Range|Number of participants who have HbA 1c values below normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
2752313|NCT00858143|Secondary|HbA 1c Values Within Normal Range|Number of participants who have HbA 1c values within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
2752314|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c)|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||Standard Deviation|Mean
2752315|NCT00858143|Secondary|IGF-I Values Above Normal Range|Number of participants who have IGF-I values above normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
2752316|NCT00858143|Secondary|IGF-I Values Within Normal Range|Number of participants who have IGF-I values within normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
2752317|NCT00858143|Secondary|Change From Baseline Insulin-like Growth Factor I (IGF-I)|Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).|Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||Standard Deviation|Mean
2752318|NCT00858130|Secondary|Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)|The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-Sym score increase at Visit 2 in comparison to Visit 1 were counted as having improved.|Vist 2 (Week 8)||||Participants|||Count of Participants
2752319|NCT00858130|Secondary|Number of Study Participants With Improvements in QOL (VEINES-QOL Score)|The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-QOL score increase at Visit 2 in comparison to Visit 1 were counted as having improved.|Vist 2 (Week 8)||||Participants|||Count of Participants
2752320|NCT00858130|Secondary|Number of Study Participants With Improvements in PTS Severity (Villalta Score)|The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness and was used to characterize PTS severity. Points are given for 11 descriptors according to severity from 0 (not present) to 3 (severe) with overall scores ranging from 0 to 33. Higher scores represent more severe disease. A score of ≥ 5 indicated mild PTS; 10-14 moderate PTS; and a score of ≥15, or the presence of a venous ulcer, indicated severe PTS. Those participants with a Villalta score decrease at Visit 2 in comparison to Visit 1 were counted as having improved.|Visit 2 (Week 8)||||Participants|||Count of Participants
2752321|NCT00858130|Secondary|"Number of Study Participants Classified as a Clinical Success"|"Clinical success was defined by the patient reporting benefit (moderate improvement of symptoms after having used the device) and an interest and willingness to continue using the device. For this study both legs were measured, but only the more severely affected leg (as determined by higher Villalta score) was used to determine clinical success. Patients were asked the following question: How much have symptoms improved? with the following possible responses: a little; moderate; a good deal; a great deal; or a very great deal."|Visit 2 (Week 8)||||Participants|||Count of Participants
2752322|NCT00858130|Primary|Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms|The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.|Visit 2 (Week 8)||||mirco coulombs (0 to 50)||Full Range|Median
2752323|NCT00858013|Secondary|HOMA-IR|insulin resistance marker HOMA-IR at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||mg/dL x mIU/L||Standard Deviation|Mean
2752324|NCT00858013|Secondary|C-peptide|c-peptide(uU/mL) at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||uU/mL||Standard Deviation|Mean
2752325|NCT00858013|Secondary|Fasting Glucose|fasting glucose (mg/dL) at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||mg/dL||Standard Deviation|Mean
2752326|NCT00858013|Secondary|HbA1c|HbA1c (%) at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||% HbA1c||Standard Deviation|Mean
2752327|NCT00858013|Primary|The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate|% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)|every 3 months following randomization, for 24 months||||Participants|||Count of Participants
2752328|NCT00857961|Secondary|Number of Participants With Adverse Events|A listing of adverse events is located in the Reported Adverse Events module.|Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)|All participants received all four doses of testosterone-MD lotion.|||participants|||Number
2752329|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]|Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||h*ng/dL||Standard Deviation|Mean
2752330|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)|Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||percent fluctuation in concentration||Standard Deviation|Mean
2752331|NCT00857961|Primary|Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||ng/dL||Standard Deviation|Mean
2752332|NCT00857961|Primary|Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||ng/dL||Standard Deviation|Mean
2752333|NCT00857961|Primary|Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||ng/dL||Standard Deviation|Mean
2752334|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)|Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion.|||hours (h)||Full Range|Median
2752335|NCT00857948|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).||Day 1 up to Day 28 post-application|Adverse events were assess in the Safety (Intent-to-treat) Population.|||Participants|||Number
2752336|NCT00857948|Secondary|Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)|The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.|Day 1 through Day 15 post-application|The level of lice infestation was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of participants|||Number
2752337|NCT00857948|Secondary|Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 8 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of participants|||Number
2752338|NCT00857948|Primary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 15 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of participants|||Number
2752339|NCT00857896|Secondary|Post-void Residual (PVR) Volume|Volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, and Week 8 post-dose|Safety Population: all participants who were known to have received study medication; Number of participants analyzed (N) = participants not performing clean intermittent bladder catheterization (CIC); n = participants not performing CIC at specified time point.|||mL||Full Range|Median
2752340|NCT00857896|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 28 and Day 56|PK Concentration|||L/hr||95% Confidence Interval|Mean
2752341|NCT00857896|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||hours||Standard Deviation|Mean
2752342|NCT00857896|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||hours||Standard Deviation|Mean
2752343|NCT00857896|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2752344|NCT00857896|Primary|Area Under the Plasma Drug Concentration Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||mcg*h/mL||Standard Deviation|Mean
2752345|NCT00857896|Primary|Apparent Volume of Distribution (VC/F)|The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.|Day 28 and Day 56|PK Concentration|||Liters (L)||95% Confidence Interval|Mean
2752346|NCT00857896|Primary|Absorption Rate Constant (Ka)||Day 28 and Day 56|Pharmacokinetic (PK) concentration population: randomized and treated participants who had at least 1 concentration during the study.|||1/hour (hr)||95% Confidence Interval|Mean
2752347|NCT00857857|Secondary|Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA)|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study. The outcome is not assessed.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. A GSK file note, dated 02 April 2009, was used to document that mRNA would no longer be collected from the sputum samples. This was due to the fact that a suitable laboratory could not be identified to carry out the analysis.||||||
2752348|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2752349|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8)|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2752350|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO)|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2752525|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||kg||Standard Error|Least Squares Mean
2752351|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||10^4 cells per milliliter of sputum||Geometric Coefficient of Variation|Geometric Mean
2752352|NCT00857857|Secondary|Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period.|Methacholine challenge PC20 data the concentration of methacholine to cause >= 20% decrease (that is change <= -20%) in FEV1 compared with saline [Baseline]) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The PC20 was obtained by linear interpolation (on the log 2 concentration scale) between the lowest concentration of methacholine that caused at least 20% decrease from Baseline and the preceding concentration. The adjusted mean is presented as LSM.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||milligrams per milliliter||95% Confidence Interval|Least Squares Mean
2752353|NCT00857857|Secondary|Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Millimoles per liter||Standard Deviation|Mean
2752354|NCT00857857|Secondary|Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Total bilirubin and direct bilirubin were also assessed on Day 7 (pre-dose).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2752355|NCT00857857|Secondary|Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Liver safety parameters (ALT and AST) were also assessed on Day 7 (pre-dose).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||International unit per liter||Standard Deviation|Mean
2752356|NCT00857857|Secondary|Mean Laboratory Values for Albumin and Total Protein|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Grams per liter||Standard Deviation|Mean
2752357|NCT00857857|Secondary|Mean Laboratory Values for Reticulocytes|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
2752358|NCT00857857|Secondary|Mean Laboratory Values for Mean Corpuscle Volume (MCV)|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Femtoliters||Standard Deviation|Mean
2752359|NCT00857857|Secondary|Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH)|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Picograms||Standard Deviation|Mean
2752360|NCT00857857|Secondary|Mean Laboratory Values for Hematocrit|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Ratio||Standard Deviation|Mean
2752361|NCT00857857|Secondary|Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Grams per liter||Standard Deviation|Mean
2752362|NCT00857857|Secondary|Change From Baseline in FEV1-non Allergen Challenge|Non-allergen challenge FEV1 data was measured on Day 1, 7, 13 and 14. The FEV1 assessments on Day 1 was taken at pre-dose and those on Day 7 was taken post-dose. On Day 13, the pre-allergen challenge FEV1 values was used and on Day 14 the pre-methacholine challenge FEV1 values was used. Absolute change in FEV1 on Day 7, 13 and 14 from pre-dose FEV1 was analyzed separately using a mixed-effects ANOVA model. Period-level Baseline was defined as the difference between the Day 1 pre-dose value and participant-level Baseline for each period, each participant. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value. Post-randomization values refer to assessments performed post dose and after the Baseline assessment. The adjusted mean is presented as LSM.|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2752363|NCT00857857|Secondary|Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Giga cells per liter||Standard Deviation|Mean
2752593|NCT00856856|Other Pre-specified|Minimum Flow Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752364|NCT00857857|Secondary|Change From Baseline in FEV1-allergen Challenge at Each Time Point|A mixed model analysis was performed separately for each planned time point during the allergen challenge on Day 13, from 5 minutes to 10 hour, including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. FEV1 was measured at 5, 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours. The adjusted mean is presented as LSM.|Up to Day 13 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Liters||95% Confidence Interval|Least Squares Mean
2752365|NCT00857857|Secondary|Number of Participants With Electrocardiogram (ECG) Findings|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. It was measured on Day 1 (pre-dose and 1 hour post dose) and Day 14 (pre and 1 hour post methacholine challenge). Participants with normal (Nr), abnormal not clinically significant (ANCS) and abnormal clinically significant (ACS) ECG was presented.|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Participants|||Count of Participants
2752366|NCT00857857|Secondary|Mean Values for Heart Rate|Participants were required to rest in the supine position for at least 10 minutes before each reading. Heart rate was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge) and Day 14 (pre and 1 hour post methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Beats per minute||Standard Deviation|Mean
2752367|NCT00857857|Secondary|Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Participants were required to rest in the supine position for at least 10 minutes before each reading. SBP and DBP was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge [pre saline]) and Day 14 (pre and 1 hour post methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2752368|NCT00857857|Secondary|Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 17 weeks|All subject population.|||Participants|||Count of Participants
2752369|NCT00857857|Secondary|Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period|Exhaled NO concentration data collected on Day 13 (2 and 12 hours post-dose) and was measured 3 times at each time point. The outcome was not assessed and data not reported.|Day 13 of each treatment period (approximately 17 weeks)|All subject population. The results were not collected for exhaled NO post-dose on Day 13.||||||
2752370|NCT00857857|Secondary|Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period|Exhaled NO concentration data collected on Day 13 (pre-dose) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The adjusted mean is presented.|Day 13 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Parts Per Billion||95% Confidence Interval|Geometric Mean
2752371|NCT00857857|Secondary|EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period.|Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 0-2 hrs post-allergen challenge (minimum EAR) was the minimum value of all the post-(bolus) allergen challenge. Weighted mean EAR was calculated for FEV1 over 0-2 hours post allergen challenge using the linear trapezoidal rule. It was measured up to and including 2 hours (5, 10, 15, 20, 30, 45 minutes and 1, 1.5 and 2 hours). The adjusted mean is presented as LSM.|0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2752385|NCT00857818|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels|Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.|Baseline to Weeks 4, 8, and 16|All randomized patients who took at least 1 dose of study medication during the treatment period. The Last Observation Carried Forward (LOCF) data set included data recorded at a given visit. If no observation was recorded at that visit, data was carried forward from the previous visit. .|||Percentage of change||Standard Error|Mean
2752372|NCT00857857|Secondary|LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period.|Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Weighted mean LAR was calculated for FEV1 over 4-10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours) post allergen challenge using the linear trapezoidal rule. To calculate weighted mean LAR, all FEV1 values recorded after the administration of rescue medication have been set to the last recorded FEV1 value prior to the administration of rescue medication. The adjusted mean is presented as Least square mean (LSM).|4-10 hours after allergen challenge on Day 13 of each treatment period|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2752373|NCT00857857|Primary|Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period|Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).|4-10 hours after allergen challenge on Day 13 of each treatment period|The all subject population was used which was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2752374|NCT00857818|Primary|Mean Baseline Fasting Non-HDL Levels||At baseline (Day 1)|All randomized patients who took at least 1 dose of study medication during the treatment period.|||mg/dL||Standard Error|Mean
2752375|NCT00857818|Secondary|Mean Changes in Serum Prolactin Levels From Baseline||Baseline to Weeks 4, 8. and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752376|NCT00857818|Secondary|Median Changes in Body Mass Index From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752377|NCT00857818|Secondary|Mean Changes in Weight From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752378|NCT00857818|Secondary|Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores|The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.|Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752379|NCT00857818|Secondary|Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count|Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, this study was terminated early, and these data were not summarized.||||||
2752380|NCT00857818|Secondary|Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752381|NCT00857818|Secondary|Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline||Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752382|NCT00857818|Secondary|Mean Changes From Baseline in Fasting Glucose Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752383|NCT00857818|Secondary|Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
2752384|NCT00857818|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs|AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.|Baseline to Week 16, continuously|All randomized subjects who took at least 1 dose of study medication during the treatment period.|||Participants|||Number
2752387|NCT00857766|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint|FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.|||milliliters||Standard Error|Mean
2752388|NCT00857766|Secondary|Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint|AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.|||% of total height of peak pulse pressure||Standard Error|Mean
2752389|NCT00857766|Primary|Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint|The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.|Baseline and the 12-Week Endpoint (up to Week 12)|Intent-to-Treat (ITT) Population: all participants who were randomized to study drug. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.|||meters per second (m/s)||Standard Error|Mean
2752390|NCT00857727|Secondary|Total Fentanyl|Total Drug used|Day 1||||mcg/kg||Standard Deviation|Mean
2752391|NCT00857727|Secondary|Total Propofol|Total Drug used|Day 1||||mg/kg||Standard Deviation|Mean
2752392|NCT00857727|Secondary|Total Sevoflurane|Total Drug used|Day 1||||ml/kg||Standard Deviation|Mean
2752393|NCT00857727|Secondary|Total Study Drug|Total Study Drug used|Day 1||||mcg/kg||Standard Deviation|Mean
2752394|NCT00857727|Secondary|Length of Surgery||Day 1||||minutes||Standard Deviation|Mean
2752395|NCT00857727|Secondary|Length of Anesthesia||Day 1||||minutes||Standard Deviation|Mean
2752396|NCT00857727|Secondary|Weight||Baseline||||kg||Standard Deviation|Mean
2752397|NCT00857727|Secondary|Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU|Vital signs were not collected as part of research study.|24 hours|data were not collected||||||
2752398|NCT00857727|Primary|Number of Participants With Emergence Delirium|Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).|15-45 minutes post-op||||participants|||Number
2752399|NCT00857714|Secondary|Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.|Number of patients with toxicity associated with short therapy with lapatinib will be reported.|Up to 60 days||||participants|||Number
2752400|NCT00857714|Primary|Number of Patients Where Gene Signature Was Obtained.|Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.|Up to 60 days||||participants|||Number
2752401|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.|"Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score.~CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from 1 = Never to 7 = Several times an hour. Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances."|Baseline to Week 24|FAS; OC|||Scores on a scale||Standard Error|Mean
2752402|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.|"Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score.~ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline to Week 24|FAS; OC|||Scores on a scale||Standard Error|Mean
2752403|NCT00857649|Secondary|Efficacy of Memantine on Global Condition Using CIBIC-plus.|"Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline.~CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Baseline to Week 24|FAS; Observed Cases (OC).|||Scores on a scale||Standard Error|Mean
2752404|NCT00857649|Primary|Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.|"Change from Baseline in Severe Impairment Battery (SIB) total score.~SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline to Week 24|FAS; LOCF|||Scores on a scale||Standard Error|Mean
2752526|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752405|NCT00857649|Primary|Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.|"Change from Baseline in Neuropsychiatric Inventory (NPI) total score.~NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline to Week 24|"Full-analysis Set (FAS) – all randomised patients on current treatment with an acetylcholinesterase inhibitor (AChEI) who took at least one dose of investigational medicinal product (IMP) and had at least one post-baseline assessment on both co-primary efficacy variables.~Last Observation Carried Forward (LOCF)."|||Scores on a scale||Standard Error|Mean
2752406|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.|From baseline to 28 days|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
2752407|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.|From baseline to day 28..|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
2752408|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.|"Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
2752409|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.|"Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
2752410|NCT00857623|Secondary|"Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least Much Improved at Day 28."|"Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.~Responder= Patient with a response of much improved or very much improved Responder rate= (no. of responders/total no. of patients)*100"|28 days|Per Protocol population (PP)|||Participants|||Number
2752411|NCT00857623|Secondary|Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)|||Participants|||Number
2752412|NCT00857623|Secondary|Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)|||Participants|||Number
2752413|NCT00857623|Secondary|Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.|Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.|From baseline to 28 days|Per Protocol population (PP)|||Scores on a scale||Standard Deviation|Mean
2752414|NCT00857623|Primary|Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment|"Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).~Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable."|From baseline to day 28|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
2752415|NCT00857584|Secondary|Number of Patients With Remission at Week 8.|"Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology|||Participants|||Number
2752416|NCT00857584|Secondary|Number of Patients With Remission at Week 4.|"Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752417|NCT00857584|Secondary|Number of Patients With Remission at Week 2.|"Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752418|NCT00857584|Secondary|Number of Patients With Remission at Week 1.|"Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752419|NCT00857584|Secondary|Number of Patients With Response at Week 8.|"Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752420|NCT00857584|Secondary|Number of Patients With Response at Week 4.|"Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752421|NCT00857584|Secondary|Number of Patients With Response at Week 2|"Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752422|NCT00857584|Secondary|Number of Patients Response at Week 1|"Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
2752423|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752424|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752425|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752426|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752427|NCT00857584|Secondary|The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752428|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology|||score on a scale||95% Confidence Interval|Mean
2752528|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752429|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline. week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752430|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752431|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
2752432|NCT00857584|Primary|The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication.|||score on a scale||95% Confidence Interval|Mean
2752433|NCT00857545|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Enrolled and randomized participants. The upper limit of the 95% confidence interval for OS median in arm 1 is not available because the data is not mature enough for estimation at the time of this report.|||Months||95% Confidence Interval|Median
2752434|NCT00857545|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.|Enrolled and randomized and treated Patients. Grade 3 or worse adverse events for gastrointestinal disorders were significantly associated with treatment arm at significant level of 0.05 by two-sided Fisher’s exact test. The reporting arm 2 had higher proportion of patients with reported grade 3 or worse adverse events.|||participants|||Number
2752435|NCT00857545|Primary|Progression-free Survival (PFS)|Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.|Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.|Enrolled and randomized participants. 95% two-sided confidence interval|||Months||95% Confidence Interval|Median
2752436|NCT00857532|Secondary|Correlation of Florbetapir SUVR With CSF Biomarker Values|Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables.|50-60 min after injection|Participants were a subset of all subjects enrolled in this study who were also part of an ongoing study looking at the usefulness of CSF biomarkers.|||Correlation Coefficient|||Number
2752437|NCT00857532|Secondary|Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.|Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.|||Correlation Coefficient|||Number
2752438|NCT00857532|Primary|Mean Cortical Amyloid Burden|Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.|||SUVR||Standard Deviation|Mean
2752527|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752439|NCT00857506|Secondary|Correlation of Change in ADAS-Cog and SUVR|Correlation between change from baseline to 36 month ADAS-Cog score and baseline global average SUVR by diagnostic group is provided below. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. Standard Uptake Value Ratio (SUVR) is the ratio of tracer uptake in the cortex and cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the cortex as compared to the cerebellum whereas scores less than 1 indicate the opposite.|Baseline and 36 months||||Pearson Correlation Coefficient|||Number
2752440|NCT00857506|Secondary|Covariate Adjusted Psychometric Score Change|Change from baseline by diagnostic group in covariate-adjusted psychometric assessment scores at month 36 (LOCF). Assessments included Digit Symbol Substitution (DSS), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Mini-Mental State Examination (MMSE), Wechsler Logical Memory Scale (WLMS) delayed and immediate recall, Category Verbal Fluency (CVF) animals and vegetables, Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL) and Geriatric Depression Scale (GDS). The ranges for these scales are as follows: DSS (0-93), CDR-SOB (0-18), MMSE (0-30), WLMS delayed and immediate recall (0-25), CVF animals and vegetables (0-total number of relevant items named in 60 seconds), ADCS ADL (0-78) and GDS (0-15). For all scales except CDR-SOB and GDS a higher score indicates greater cognitive function. For CDR-SOB and GDS a higher score indicates increased dementia or depression, respectively.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Scores on a scale||Standard Error|Mean
2752441|NCT00857506|Secondary|Cognitive Decline in CN and AD Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the CN and AD populations with clinically significant deterioration in ADAS-Cog (≥4) and CDR global score (≥0.5). ADAS-Cog scores (range 0-70) indicate performance on a series of cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Participants|||Number
2752442|NCT00857506|Secondary|Change in ADAS-Cog in CN and AD Subjects|This analysis compared the magnitude of change from baseline in ADAS cognitive subscale (ADAS-Cog) scores between Aβ+ and Aβ- subjects in the CN and AD populations at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Scores on a scale||Standard Error|Mean
2752443|NCT00857506|Secondary|Cognitive Decline in MCI Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the MCI population with clinically significant deterioration in ADAS-Cog (≥4) and Clinical Dementia Rating (CDR) global score (≥0.5) and conversion in diagnosis from MCI at baseline to AD or Cognitively Normal (CN) at 36 months. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Participants|||Number
2752444|NCT00857506|Primary|Change in ADAS-Cog for MCI Subjects|The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward [LOCF]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Scores on a scale||Standard Error|Mean
2752445|NCT00857493|Secondary|Correlation PRNT vs ELISA Titers|Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers|within 32 weeks|Full Analysis Set|||Pearson correlation coefficient||95% Confidence Interval|Number
2752446|NCT00857493|Secondary|PRNT GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.|within 32 weeks|Full Analysis Set|||Titer||95% Confidence Interval|Geometric Mean
2752447|NCT00857493|Secondary|PRNT Seroconversion Rate|Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.|within 32 weeks|Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2755799|NCT00836355|Secondary|NIH Stroke Scale Scores||Baseline and after approximately one week|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.||||||
2752448|NCT00857493|Secondary|PRNT Response Rate|Response rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Response is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.|within 32 weeks|Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2752449|NCT00857493|Secondary|ELISA GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.|within 32 weeks|Full Analysis Set|||Titer||95% Confidence Interval|Geometric Mean
2752450|NCT00857493|Secondary|ELISA Seroconversion Rate|Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.|within 32 weeks|Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2752451|NCT00857493|Secondary|ELISA Response Rate|Response rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.|within 32 weeks|Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2752452|NCT00857493|Secondary|Solicited General Adverse Events|Incidence of solicited general AEs (body temperature increased, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship tovaccination. Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Safety Analysis Set|||Participants|||Count of Participants
2752453|NCT00857493|Secondary|Solicited Local Adverse Events|Incidence and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritus). Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Safety Analysis Set|||Participants|||Count of Participants
2752454|NCT00857493|Secondary|Cardiac Signs or Symptoms|Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzymes elevated above 2 x upper limit of normal range (ULN).|within 32 weeks|Safety Analysis Set|||Participants|||Count of Participants
2752455|NCT00857493|Secondary|Related Grade >=3 Adverse Events|Incidence of any Grade >=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general) and unsolicited AEs|within 29 days after any vaccination|Safety Analysis Set|||Participants|||Count of Participants
2752456|NCT00857493|Secondary|Unsolicited Non-serious AEs: Relationship to Vaccination|Occurrence of unsolicited non-serious AEs by relationship to study vaccine|within 29 days after any vaccination|Safety Analysis Set|||events|||Number
2752457|NCT00857493|Secondary|Unsolicited Non-serious AEs: Intensity|Occurrence of unsolicited non-serious AEs by Intensity|within 29 days after any vaccination|Safety Analysis Set|||events|||Number
2752458|NCT00857493|Primary|Related Serious Adverse Events|Incidence of Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine|within 8 weeks|Safety Analysis Set|||Participants|||Count of Participants
2752459|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||percentage of red blood cells in sample||Standard Deviation|Mean
2752460|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||grams per deciliter (g/dL)||Standard Deviation|Mean
2752461|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Estradiol||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2752462|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||mIU/mL||Standard Deviation|Mean
2752463|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2752464|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2752465|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||uIU/mL||Standard Deviation|Mean
2752494|NCT00857233|Secondary|Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.|"Change from Baseline in the SIB total score. Analysed by descriptive methods only.~SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline and Week 24|APTS; OC|||Scores on a scale||Standard Deviation|Mean
2752466|NCT00857454|Primary|Change From Baseline MTE08 to MTE09 Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Day 1, Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190).|||units on a scale||Standard Deviation|Mean
2752467|NCT00857415|Secondary|Regional Correlation Analysis|Spearman's rank order correlation of median visual read of the florbetapir-PET image vs. amyloid plaque density assessed post-mortem by quantitative IHC of six individual brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners|||Correlation coefficient||95% Confidence Interval|Number
2752468|NCT00857415|Primary|Specificity Analysis|Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.|50-60 min after injection|Per protocol, 27 subjects who were genetic carriers for ApoE e4 or whose genetic status was unknown were excluded from the analysis|||participants|||Number
2752469|NCT00857415|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners|||Correlation coefficient||95% Confidence Interval|Number
2752470|NCT00857389|Secondary|Relapse Rate of Participants Treated With Thiotepa, Busulfan, and Clofarabine|Relapse Rate will be estimated using the Kaplan-Meier method.|Up to 2 years post transplant||||Participants|||Count of Participants
2752471|NCT00857389|Secondary|Number of Participants With Serious Adverse Events|Severity of toxicities graded according to the NCI Common Toxicity Criteria Adverse Effects (CTCAE) v3.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency.|up to 30 days post transplant||||Participants|||Count of Participants
2752472|NCT00857389|Secondary|Engraftment|Engraftment is most commonly defined as the first of three consecutive days of achieving a sustained peripheral blood neutrophil count of >500 × 10^6/L .|up to 100 days post transplant||||Participants|||Count of Participants
2752473|NCT00857389|Secondary|Graft vs Host Disease (GVHD)|Severity of toxicities graded according to the NCI Common Toxicity Criteria Adverse Effects (CTCAE) v3.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency.|Up to 30 days post transplant||||Participants|||Count of Participants
2752474|NCT00857389|Secondary|Overall Survival Rate|Overall Survival Rate will be estimated using the Kaplan-Meier method.|Up to 3 years post transplant||||days||Full Range|Median
2752475|NCT00857389|Secondary|Number of Participants With Disease Free Survival|Kaplan-Meier product limit method to estimate the disease free survival.|Up to 2 years post transplant||||Participants|||Count of Participants
2752476|NCT00857389|Primary|Number of Participants With Survival Rate at 100 Days Post-transplant|The toxicities will be monitored and scored on a daily basis following the methods of Simon R. Practical Bayesian Guideline for Phase IIB Clinical Trials. A Bayesian stopping rule will be used to stop the trial if there is a 90% chance that the true toxicity rate exceeds the target toxicity rate of 0.25.|100 days post-transplant||||Participants|||Count of Participants
2752477|NCT00857311|Primary|Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)|"Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site.~Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine."|up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs||||Participants|||Number
2752478|NCT00857311|Secondary|Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen|"Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).~No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious."|Week 30 (4 weeks after boost injection)|No analysis was performed.||||||
2752479|NCT00857311|Secondary|Number of Participants With Systemic and Laboratory Adverse Events (AE)|Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.|up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs||||Participants|||Number
2752480|NCT00857285|Primary|Mean Change of Sitting dBP From Baseline to Week 12|The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.|Baseline to 12 weeks|Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.|||mmHg||Standard Error|Mean
2752481|NCT00857272|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|"Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = excellent (no more than small bits of adherent feces/fluid); 3 = good (small amounts of feces or fluid not interfering with the exam); 2 = fair (enough feces or fluid to prevent a completely reliable exam); 1 = poor (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a success and grades of 2 or 1 were considered a failure."|during colonoscopy|The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy.|||percent of participants||95% Confidence Interval|Number
2752482|NCT00857259|Secondary|Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus|Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart.|Baseline and week 4|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.|||Letters||Standard Deviation|Mean
2752483|NCT00857259|Primary|Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)|Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.|Baseline and 4 weeks|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.|||µm||Standard Deviation|Mean
2752484|NCT00857246|Secondary|Median Overall Survival (Adjuvant Therpary)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who received at least one cycle of adjuvant therapy|||months||Full Range|Median
2752485|NCT00857246|Secondary|Median Overall Survival (Induction Treatment and Curative Surgery)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who completed induction treatment and underwent curative surgery|||months||Full Range|Median
2752486|NCT00857246|Secondary|Safety of the Induction Regimen|This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.|4 months from the beginning of the induction|Patients who had at least a dose of treatment|||participants|||Number
2752487|NCT00857246|Secondary|"Rate of Down-staging From Pre-operative Clinical Staging"|This is defined as the percentage of patients who had a reduction from T3/T4 disease.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)|||percentage of participants|||Number
2752488|NCT00857246|Secondary|Rate of Potentially Curative Surgery|This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).|4 months from the beginning of the induction treatment|patients who underwent surgery|||percentage of participants|||Number
2752489|NCT00857246|Secondary|Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy|This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)|||percentage of participants|||Number
2752490|NCT00857246|Primary|Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab|"Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any down-staging of T or N stage is considered to be a result of induction therapy and counted as a clinical response."|4 months from the beginning of the induction regimen|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)|||percentage of paticipants|||Number
2752491|NCT00857233|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 24|APTS|||percentage of participants|||Number
2752492|NCT00857233|Secondary|Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score|"Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only.~ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline and Week 24|APTS; OC|||Scores on a scale||Standard Deviation|Mean
2752493|NCT00857233|Secondary|Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).|"CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only.~CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Week 24|APTS; OC|||Scores on a scale||Standard Deviation|Mean
2752505|NCT00857220|Secondary|Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12|A 7-point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||units on a scale||Standard Deviation|Mean
2752495|NCT00857233|Secondary|Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.|"Change from Baseline in the NPI total score. Analysed by descriptive methods only.~NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline and Week 24|APTS; Observed cases (OC)|||Scores on a scale||Standard Deviation|Mean
2752496|NCT00857233|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Baseline to Week 24|Completers from lead-in study 10158 were eligible for this open-label extension study. We analysed the All-patients-treated Set (APTS) - all patients who took at least one dose of investigational medicinal product (IMP)|||participants|||Number
2752497|NCT00857220|Secondary|Change From Baseline in Pediatric Quality of Life Scale|The SF-10™ Health Survey for Children is a 10-item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF-10 physical and psychosocial summary measures were scored such that higher scores indicated more favorable functioning. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||units on a scale||Standard Deviation|Mean
2752498|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Minutes||Standard Deviation|Mean
2752499|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Number of Awakenings||Standard Deviation|Mean
2752500|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Minutes||Standard Deviation|Mean
2752501|NCT00857220|Secondary|Change From Baseline in Conners' Continuous Performance Test II (CCPT II)|The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners' CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d'), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||percentage of score||Standard Deviation|Mean
2752502|NCT00857220|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12|The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population|||units on a scale||Standard Deviation|Mean
2752503|NCT00857220|Secondary|Change From Baseline in Child Behavior Checklist (CBCL)|CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject's age group and gender from the raw score and then dividing this by the standard deviation for the subject's age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||units on a scale||Standard Deviation|Mean
2752504|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Sleep Latency (SL)|Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Minutes||Standard Deviation|Mean
2752586|NCT00856856|Other Pre-specified|Mean Flow Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752506|NCT00857220|Secondary|Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population|||score||Standard Deviation|Mean
2752507|NCT00857220|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses|The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).|12 Months|Intent to treat population|||Subjects|||Number
2752508|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Participant Affected||12 Months (from the 1st dose to the end of study)|Intent to treat population|||participants|||Number
2752509|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Events||12 Months (from the 1st dose to the end of study)|Intent to treat population|||Events|||Number
2752510|NCT00857220|Primary|Overall Incidence of Adverse Events||12 Months (from the 1st dose to the end of study)|The intent-to-treat (ITT) population consisted of all enrolled subjects who had taken any study medication. One subject did not receive study medication|||participants|||Number
2752511|NCT00856999|Primary|Patient Assessed Frown-line Improvement|"Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score)~Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase"|20 months||||percentage of patients|||Number
2752512|NCT00856999|Primary|Reduction of the Facial Wrinkle Scale|"Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles)~Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase"|26 months||||units on a scale||Standard Deviation|Mean
2752513|NCT00856986|Secondary|Hypoglycaemic Episodes Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 0-52|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis|||episodes|||Number
2752514|NCT00856986|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
2752515|NCT00856986|Secondary|Adverse Events From Run-in (Week -12) to Week 52||Run-in (week -12) to Week 52|The Safety Analysis Set included all exposed subjects|||events|||Number
2752516|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmHg||Standard Error|Least Squares Mean
2752517|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmHg||Standard Error|Least Squares Mean
2752518|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 52|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm/cm||Standard Error|Least Squares Mean
2752519|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 26|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm/cm||Standard Error|Least Squares Mean
2752520|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 52||Week 0, week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm||Standard Error|Least Squares Mean
2752521|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm||Standard Error|Least Squares Mean
2752529|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752530|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 52.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752531|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 26.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752532|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752533|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752534|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||pmol/L||Standard Error|Least Squares Mean
2752535|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||pmol/L||Standard Error|Least Squares Mean
2752536|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 52||Week 0 (Randomisation), Week 52|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.||||||
2752537|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 26||Week 0 (Randomisation), Week 26|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.||||||
2752538|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752539|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752540|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752541|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
2752542|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)||Week 0, Week 52|The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2752543|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2752544|NCT00856986|Primary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.||Week 0 (Randomisation), week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2752587|NCT00856856|Other Pre-specified|Percent (%) Lumen Area Stenosis||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of Lumen Area Stenosis|Target lesions|Standard Deviation|Mean
2752545|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Hours)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population|||Hours||Standard Error|Least Squares Mean
2752546|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Days)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population|||Days||Standard Error|Least Squares Mean
2752547|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective Number of Awakenings After Sleep Onset (NAASO)|||Number of Awakenings||Standard Error|Least Squares Mean
2752548|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).|The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Pediatric Quality-of-Life Scale (Short Form-10)|||units on a scale||Standard Error|Least Squares Mean
2752549|NCT00856973|Secondary|Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score|||Score||Standard Error|Least Squares Mean
2752550|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.|The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score|||units on a scale||Standard Error|Least Squares Mean
2752551|NCT00856973|Secondary|Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population|||Minutes||Standard Error|Least Squares Mean
2752552|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|Actigraphy population which included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population|||Minutes||Standard Error|Least Squares Mean
2752553|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population|||Minutes||Standard Error|Least Squares Mean
2752554|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective Total Sleep Time|||Minutes||Standard Error|Least Squares Mean
2752555|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)|A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined Total Sleep Time|||Minutes||Standard Error|Least Squares Mean
2752556|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).|A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject's sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined of Awakenings After Sleep Onset|||Number of Awakenings after sleep onse||Standard Error|Least Squares Mean
2752557|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)|A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined sleep efficiency|||percentage of SE||Standard Error|Least Squares Mean
2752558|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective WASO|||Minutes||Standard Error|Least Squares Mean
2752559|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective SL (Sleep Latency)|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective sleep latency|||Minutes||Standard Error|Least Squares Mean
2752560|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.|The Conners' 3 -Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners' 3 -Parent Short Form was a subset of items from the full-length form, and included the Conners' 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Conners’ ADHD Inattention rating scale|||units on a scale||Standard Error|Least Squares Mean
2752561|NCT00856973|Secondary|Change From Baseline in CGI-Child at Week 12|The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject's assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Child|||Units on a scale||Standard Error|Least Squares Mean
2752562|NCT00856973|Secondary|Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12|The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject's parent or caregiver and represented their assessment of severity and improvement in the subject's symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Parent/Caregiver|||Units on a scale||Standard Error|Least Squares Mean
2752563|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)|A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 WASO|||Minutes||Standard Error|Least Squares Mean
2752588|NCT00856856|Other Pre-specified|Mean Strut Core Area||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752589|NCT00856856|Other Pre-specified|Minimum Flow Area||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752564|NCT00856973|Primary|Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).|A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.|Baseline (Day 0) to Week 12|Intent to treat (ITT) population with both baseline and week 12 LPS. ITT refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.|||minutes||Standard Error|Least Squares Mean
2752565|NCT00856934|Secondary|Pain|Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.|Post operative day 5||||VAS Pain Score||Standard Deviation|Mean
2752566|NCT00856934|Primary|Complete Wound Healing|Time required for complete epithelialization in days|Post operative day 5 and every other day thereafter||||Days||Standard Deviation|Mean
2752567|NCT00856908|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment||||relative change in percent||95% Confidence Interval|Least Squares Mean
2752568|NCT00856908|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100|Baseline is the day before first dose, end of treatment is last day of treatment||||relative change in percent||95% Confidence Interval|Least Squares Mean
2752569|NCT00856908|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment||||relative change in percent||95% Confidence Interval|Least Squares Mean
2752570|NCT00856908|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment||||L/h||Full Range|Mean
2752571|NCT00856908|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the evening dose last day of treatment||||h||Full Range|Mean
2752572|NCT00856908|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment||||h||Full Range|Median
2752573|NCT00856908|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured following the morning dose last day of treatment||||umol/L||95% Confidence Interval|Geometric Mean
2752574|NCT00856908|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment||||umol*h/L||95% Confidence Interval|Geometric Mean
2752575|NCT00856908|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose||||Participants|||Number
2752576|NCT00856908|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment||||kg||Standard Deviation|Mean
2752577|NCT00856908|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||beats/min||Standard Deviation|Mean
2752578|NCT00856908|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
2752579|NCT00856908|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
2752580|NCT00856856|Other Pre-specified|Percent (%) Lumen Area Stenosis||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of Lumen Area Stenosis|Target lesions|Standard Deviation|Mean
2752581|NCT00856856|Other Pre-specified|Minimum Flow Area||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752582|NCT00856856|Other Pre-specified|Mean Flow Area||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752583|NCT00856856|Other Pre-specified|Percent (%) Lumen Area Stenosis||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of Lumen Area Stenosis|Target lesions|Standard Deviation|Mean
2752584|NCT00856856|Other Pre-specified|Mean Strut Core Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752585|NCT00856856|Other Pre-specified|Minimum Flow Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752594|NCT00856856|Other Pre-specified|Mean Flow Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752595|NCT00856856|Other Pre-specified|Tissue Coverage Obstruction Volume BVS||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Tissue Coverage Obstruction|Target lesions|Standard Deviation|Mean
2752596|NCT00856856|Other Pre-specified|Tissue Coverage Obstruction Volume Classical||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Tissue Coverage Obstruction|Target lesions|Standard Deviation|Mean
2752597|NCT00856856|Other Pre-specified|Tissue Coverage Volume BVS||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752598|NCT00856856|Other Pre-specified|Tissue Coverage Volume Classical||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752599|NCT00856856|Other Pre-specified|Tissue Coverage Area BVS (Neointimal Area)||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752600|NCT00856856|Other Pre-specified|Tissue Coverage Area Classical||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752601|NCT00856856|Other Pre-specified|Tissue Coverage Obstruction Volume BVS||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Tissue Coverage Obstruction|Target lesions|Standard Deviation|Mean
2752602|NCT00856856|Other Pre-specified|Tissue Coverage Obstruction Volume Classical||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Tissue Coverage Obstruction|Target lesions|Standard Deviation|Mean
2752603|NCT00856856|Other Pre-specified|Tissue Coverage Volume BVS||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752604|NCT00856856|Other Pre-specified|Tissue Coverage Volume Classical||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752605|NCT00856856|Other Pre-specified|Tissue Coverage Area BVS (Neointimal Area)||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752606|NCT00856856|Other Pre-specified|Tissue Coverage Area Classical||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752607|NCT00856856|Other Pre-specified|Tissue Coverage Obstruction Volume BVS||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Tissue Coverage Obstruction|Target lesions|Standard Deviation|Mean
2752608|NCT00856856|Other Pre-specified|Tissue Coverage Obstruction Volume Classical||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Tissue Coverage Obstruction|Target lesions|Standard Deviation|Mean
2752609|NCT00856856|Other Pre-specified|Tissue Coverage Volume BVS||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752610|NCT00856856|Other Pre-specified|Tissue Coverage Volume Classical||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752611|NCT00856856|Other Pre-specified|Tissue Coverage Area BVS (Neointimal Area)||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752612|NCT00856856|Other Pre-specified|Tissue Coverage Area Classical||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752613|NCT00856856|Other Pre-specified|Number of Struts in Side Branch||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of struts|Target lesions|Standard Deviation|Mean
2752614|NCT00856856|Other Pre-specified|Number of Struts in Side Branch||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of struts|Target lesions|Standard Deviation|Mean
2752615|NCT00856856|Other Pre-specified|Number of Struts in Side Branch||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of struts|Target lesions|Standard Deviation|Mean
2752616|NCT00856856|Other Pre-specified|Number of Struts in Side Branch||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of struts|Target lesions|Standard Deviation|Mean
2752617|NCT00856856|Other Pre-specified|% of Uncovered Struts (150 µm)||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Uncovered Struts|Target lesions|Standard Deviation|Mean
2752618|NCT00856856|Other Pre-specified|% of Uncovered Struts (150 µm)||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Uncovered Struts|Target lesions|Standard Deviation|Mean
2752619|NCT00856856|Other Pre-specified|% of Uncovered Struts (150 µm)||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Uncovered Struts|Target lesions|Standard Deviation|Mean
2752620|NCT00856856|Other Pre-specified|% of Acutely Covered Struts||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Covered Struts|Target lesions|Standard Deviation|Mean
2752621|NCT00856856|Other Pre-specified|% of Acutely Covered Struts||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Covered Struts|Target lesions|Standard Deviation|Mean
2752622|NCT00856856|Other Pre-specified|% of Covered Struts (150 µm)||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percent of Covered Struts|Target lesions|Standard Deviation|Mean
2752623|NCT00856856|Other Pre-specified|Number of Struts Per BVS||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of Struts|Target lesions|Standard Deviation|Mean
2752624|NCT00856856|Other Pre-specified|Number of Struts Per BVS||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of Struts|Target lesions|Standard Deviation|Mean
2752625|NCT00856856|Other Pre-specified|Number of Struts Per BVS||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of Struts|Target lesions|Standard Deviation|Mean
2752626|NCT00856856|Other Pre-specified|Number of Struts Per BVS||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Number of Struts|Target lesions|Standard Deviation|Mean
2752627|NCT00856856|Other Pre-specified|Strut Volume||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752628|NCT00856856|Other Pre-specified|Strut Volume||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752629|NCT00856856|Other Pre-specified|Strut Volume||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752630|NCT00856856|Other Pre-specified|Minimum Scaffold Diameter||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752631|NCT00856856|Other Pre-specified|Minimum Scaffold Diameter||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752632|NCT00856856|Other Pre-specified|Minimum Stent Diameter||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752633|NCT00856856|Other Pre-specified|Mean Scaffold Diameter||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752634|NCT00856856|Other Pre-specified|Mean Scaffold Diameter||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752635|NCT00856856|Other Pre-specified|Mean Stent Diameter||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752636|NCT00856856|Other Pre-specified|Minimum Luminal Diameter|The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.|5 years|Cohort B (Group1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752637|NCT00856856|Other Pre-specified|Minimum Luminal Diameter|The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.|3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752638|NCT00856856|Other Pre-specified|Minimum Luminal Diameter|The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.|2 years|Cohort B Group 1 , Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752639|NCT00856856|Other Pre-specified|Minimum Luminal Diameter (MLD)|The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.|1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752640|NCT00856856|Other Pre-specified|Mean Luminal Diameter|It is measured during QCA by the Angiographic Core Lab.|5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752641|NCT00856856|Other Pre-specified|Mean Luminal Diameter||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752642|NCT00856856|Other Pre-specified|Mean Luminal Diameter||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752643|NCT00856856|Other Pre-specified|Mean Luminal Diameter||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm|Target lesions|Standard Deviation|Mean
2752644|NCT00856856|Other Pre-specified|Scaffold Volume||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752645|NCT00856856|Other Pre-specified|Scaffold Volume||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752646|NCT00856856|Other Pre-specified|Stent Volume||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752647|NCT00856856|Other Pre-specified|Luminal Volume||5 years|Cohort B Group 1 and Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752648|NCT00856856|Other Pre-specified|Luminal Volume||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752649|NCT00856856|Other Pre-specified|Luminal Volume||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752650|NCT00856856|Other Pre-specified|Luminal Volume||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^3|Target lesions|Standard Deviation|Mean
2752651|NCT00856856|Other Pre-specified|Minimum Scaffold Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752652|NCT00856856|Other Pre-specified|Minimum Scaffold Area||2 year|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752653|NCT00856856|Other Pre-specified|Minimum Stent Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752654|NCT00856856|Other Pre-specified|Mean Scaffold Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752655|NCT00856856|Other Pre-specified|Mean Scaffold Area||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752656|NCT00856856|Other Pre-specified|Mean Stent Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752657|NCT00856856|Other Pre-specified|Minimum Luminal Area||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752658|NCT00856856|Other Pre-specified|Minimum Luminal Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752659|NCT00856856|Other Pre-specified|Minimum Luminal Area||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752660|NCT00856856|Other Pre-specified|Minimum Luminal Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752661|NCT00856856|Other Pre-specified|Mean Luminal Area||5 years|Cohort B (Group 1 and Group 2), Intent-to-Treat (ITT) Population.OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752662|NCT00856856|Other Pre-specified|Mean Luminal Area||3 years|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752663|NCT00856856|Other Pre-specified|Mean Luminal Area||2 years|Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752664|NCT00856856|Other Pre-specified|Mean Luminal Area||1 year|Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752665|NCT00856856|Other Pre-specified|Mean Reference Area||5 years|OCT analysis,Cohort B (Group 1 and Group 2), Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752666|NCT00856856|Other Pre-specified|Mean Reference Area||3 years|OCT analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752667|NCT00856856|Other Pre-specified|Mean Reference Area||2 years|OCT analysis,Cohort B Group1 , Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752668|NCT00856856|Other Pre-specified|Mean Reference Area||1 year|Optical coherence tomography (OCT) analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||mm^2|Target lesions|Standard Deviation|Mean
2752669|NCT00856856|Secondary|Late Incomplete Apposition|"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|3 year|Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752670|NCT00856856|Secondary|Late Incomplete Apposition|"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|2 year|Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752671|NCT00856856|Secondary|Late Incomplete Apposition|"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|1 year|Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752672|NCT00856856|Secondary|Late Incomplete Apposition|"Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|180 days|Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752673|NCT00856856|Secondary|Persisting Incomplete Apposition|"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|3 year|Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752674|NCT00856856|Secondary|Persisting Incomplete Apposition|"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|2 year|Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752675|NCT00856856|Secondary|Persisting Incomplete Apposition|"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|1 year|Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752676|NCT00856856|Secondary|Persisting Incomplete Apposition|"Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.~Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image."|180 days|Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|||Number
2752677|NCT00856856|Secondary|Volume Obstruction (VO)|Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.|3 year|Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percent of scaffold volume|Target lesions|Standard Deviation|Mean
2755857|NCT00835861|Secondary|Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester||1st, 2nd, and 3rd trimester||||percentage of glycosolated hemoglobin||Inter-Quartile Range|Median
2752678|NCT00856856|Secondary|Volume Obstruction (VO)|Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.|2 year|Cohort B, Group 1. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percent of scaffold volume|Target lesions|Standard Deviation|Mean
2752679|NCT00856856|Secondary|Volume Obstruction (VO)|Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.|1 year|Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percent of scaffold volume|Target lesions|Standard Deviation|Mean
2752680|NCT00856856|Secondary|Volume Obstruction (VO)|Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.|180 days|Cohort B, Group 1. ITT population; Intravascular ultrasound (IVUS) analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percent of scaffold volume|Target lesions|Standard Deviation|Mean
2752681|NCT00856856|Secondary|Vasomotion Analysis: In-scaffold Mean Luminal Diameter|Vasomotion function was assessed in reaction to nitrate administration.|5 years|Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752682|NCT00856856|Secondary|Thrombus||5 years|Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752683|NCT00856856|Secondary|Thrombus||3 years|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752684|NCT00856856|Secondary|Thrombus||2 years|Intent-to-treat (ITT) population.Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752685|NCT00856856|Secondary|Thrombus||1 year|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752686|NCT00856856|Secondary|Thrombus||180 days|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752687|NCT00856856|Secondary|Aneurysm|An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.|5 years|Intent-to-treat (ITT) population.Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752688|NCT00856856|Secondary|Aneurysm|An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.|3 years|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752689|NCT00856856|Secondary|Aneurysm|An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.|2 years|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752690|NCT00856856|Secondary|Aneurysm|An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.|1 year|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752691|NCT00856856|Secondary|Aneurysm|An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.|180 days|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752692|NCT00856856|Secondary|In-scaffold Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|5 years|Intent-to-treat (ITT) population. Cohort B, Group 1 and Group2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percentage of diameter stenosis|Target lesions|Standard Deviation|Mean
2752693|NCT00856856|Secondary|In-scaffold Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|3 years|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percentage of diameter stenosis|Target lesions|Standard Deviation|Mean
2752694|NCT00856856|Secondary|In-scaffold Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|2 years|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percentage of diameter stenosis|Target lesions|Standard Deviation|Mean
2752695|NCT00856856|Secondary|In-scaffold Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|1 year|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percentage of diameter stenosis|Target lesions|Standard Deviation|Mean
2752902|NCT00856388|Secondary|Median Time to Platelet Engraftment|"Median Time to Platelet Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Day 100|All treated and eligible patients|||Days||Full Range|Median
2752696|NCT00856856|Secondary|In-scaffold Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|180 days|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||percentage of diameter stenosis|Target lesions|Standard Deviation|Mean
2752697|NCT00856856|Secondary|Persisting Dissection|Dissection at follow-up that was present post-procedure.|5 years|ITT population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752698|NCT00856856|Secondary|Persisting Dissection|Dissection at follow-up that was present post-procedure.|3 years|ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752699|NCT00856856|Secondary|Persisting Dissection|Dissection at follow-up that was present post-procedure.|2 years|ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752700|NCT00856856|Secondary|Persisting Dissection|Dissection at follow-up that was present post-procedure.|1 year|ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752701|NCT00856856|Secondary|Persisting Dissection|Dissection at follow-up that was present post-procedure.|180 days|ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752702|NCT00856856|Secondary|In-scaffold Angiographic Binary Restenosis (ABR)|Percent of patients with a followup percent diameter stenosis of >=50% per QCA.|5 years|Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752703|NCT00856856|Secondary|In-scaffold Angiographic Binary Restenosis (ABR)|Percent of patients with a followup percent diameter stenosis of >=50% per QCA.|3 years|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752704|NCT00856856|Secondary|In-scaffold Angiographic Binary Restenosis (ABR)|Percent of patients with a followup percent diameter stenosis of >=50% per QCA.|2 years|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752705|NCT00856856|Secondary|In-scaffold Angiographic Binary Restenosis (ABR)|Percent of patients with a followup percent diameter stenosis of >=50% per QCA.|1 year|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752706|NCT00856856|Secondary|In-scaffold Angiographic Binary Restenosis (ABR)|Percent of patients with a followup percent diameter stenosis of >=50% per QCA.|180 days|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Percentage of participants|Target lesions||Number
2752707|NCT00856856|Secondary|Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years|Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).|5 years|Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752708|NCT00856856|Secondary|Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years|Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).|3 years|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752709|NCT00856856|Secondary|Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years|Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).|2 years|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752710|NCT00856856|Secondary|Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year|Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).|1 year|Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752711|NCT00856856|Secondary|Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days|Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).|180 days|Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752712|NCT00856856|Secondary|Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years|Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).|5 years|Intent-to-treat (ITT) population. In Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752713|NCT00856856|Secondary|Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years|Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).|3 years|Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752714|NCT00856856|Secondary|Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years|Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).|2 years|Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752715|NCT00856856|Secondary|Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year|Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).|1 year|Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752716|NCT00856856|Secondary|Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days|Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).|180 days|Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752717|NCT00856856|Secondary|In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years|In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.|5 years|Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752718|NCT00856856|Secondary|In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years|In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.|3 years|Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752719|NCT00856856|Secondary|In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years|In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.|2 years|ITT population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752720|NCT00856856|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|5 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.|||percentage of participants|||Number
2752721|NCT00856856|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|4 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.|||percentage of participants|||Number
2752722|NCT00856856|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||percentage of participants|||Number
2752723|NCT00856856|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||percentage of participants|||Number
2752724|NCT00856856|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|1 year|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752725|NCT00856856|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)~Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|30 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752726|NCT00856856|Secondary|Myocardial Infarction|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|5 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.|||percentage of participants|||Number
2752727|NCT00856856|Secondary|Myocardial Infarction|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.|||percentage of participants|||Number
2752728|NCT00856856|Secondary|Myocardial Infarction|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||percentage of participants|||Number
2752729|NCT00856856|Secondary|Myocardial Infarction|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||percentage of participants|||Number
2752730|NCT00856856|Secondary|Myocardial Infarction|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752731|NCT00856856|Secondary|Myocardial Infarction|"Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|30 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752732|NCT00856856|Secondary|Cardiac Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)"|5 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.|||percentage of participants|||Number
2752733|NCT00856856|Secondary|Cardiac Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)"|4 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.|||percentage of participants|||Number
2752734|NCT00856856|Secondary|Cardiac Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)"|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||percentage of participants|||Number
2752735|NCT00856856|Secondary|Cardiac Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)"|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||percentage of participants|||Number
2752758|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 year|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752736|NCT00856856|Secondary|Cardiac Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)"|1 year|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752737|NCT00856856|Secondary|Cardiac Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)"|30 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752738|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|5 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.|||Percentage of participants|||Number
2752739|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|4 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patient (Group 1) lost to follow-up at 4-year follow-up period.|||Percentage of participants|||Number
2752740|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||Percentage of participants|||Number
2752741|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||Percentage of participants|||Number
2752742|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|1 year|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752743|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|270 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752744|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|180 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752745|NCT00856856|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"ID-TVR is the revascularization in the target vessel associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|30 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752759|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|270 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752903|NCT00856388|Secondary|Median Time to ANC Engraftment|"Median Time to ANC Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Days 30|All treated and eligible patients|||Days||Full Range|Median
2752746|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|5 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.|||percentage of participants|||Number
2752747|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|4 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.|||percentage of participants|||Number
2752748|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||percentage of participants|||Number
2752749|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||percentage of participants|||Number
2752750|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|1 year|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752751|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|270 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752752|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|180 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752753|NCT00856856|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"ID-TLR is defined as the revascularization at the target lesion associated with any of the following:~Positive functional ischemia study~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|30 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752754|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.|||percentage of participants|||Number
2752755|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.|||percentage of participants|||Number
2752756|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||percentage of participants|||Number
2752757|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||percentage of participants|||Number
2752760|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|180 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||Percentage of participants|||Number
2752761|NCT00856856|Secondary|Hierarchical Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|30 days|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.|||percentage of participants|||Number
2752762|NCT00856856|Secondary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|5 years|Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752763|NCT00856856|Secondary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|4 years|Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752764|NCT00856856|Secondary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|3 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.|||percentage of participants|||Number
2752765|NCT00856856|Secondary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|2 years|Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.|||percentage of participants|||Number
2752766|NCT00856856|Secondary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|270 days|Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752767|NCT00856856|Secondary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|180 days|Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752768|NCT00856856|Secondary|Clinical Procedure Success (Per Patient)|Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.|On day 0 (the day of procedure)|Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752769|NCT00856856|Secondary|Clinical Device Success (Per Lesion)|Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.|On day 0 (the day of procedure)|Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.|||percentage of lesions|Target lesions||Number
2752770|NCT00856856|Primary|In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year|In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up|1 year|In Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752771|NCT00856856|Primary|In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days|In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.|180 days|In Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Millimeter|Target lesions|Standard Deviation|Mean
2752772|NCT00856856|Primary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|1 year|Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752773|NCT00856856|Primary|Hierarchical Major Adverse Cardiac Event (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).|30 days|Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.|||percentage of participants|||Number
2752774|NCT00856843|Secondary|Mean Change in Serum Chemistry (mEq/L)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days||||mEq/L||Standard Deviation|Mean
2752898|NCT00856388|Secondary|1 yr Extenstive Chronic GVHD|"1 yr Extensive Chronic GVHD~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to 4.5 years|All treated and eligible who survived to day 100 and were eligible to get chronic GVHD|||percentage of participants||95% Confidence Interval|Number
2752775|NCT00856843|Secondary|Mean Change in Serum Chemistry (mg/dL)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days||||mg/dL||Standard Deviation|Mean
2752776|NCT00856843|Secondary|Subject Symptom Scores|Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).|2 days||||units on a scale||Standard Deviation|Mean
2752777|NCT00856843|Secondary|Assessment of Residual Fluid - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752778|NCT00856843|Secondary|Assessment of Residual Fluid - Descending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752779|NCT00856843|Secondary|Assessment of Residual Fluid - Transverse Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752780|NCT00856843|Secondary|Assessment of Residual Fluid - Ascending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752781|NCT00856843|Secondary|Assessment of Residual Fluid - Cecum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752782|NCT00856843|Secondary|Assessment of Residual Stool - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752783|NCT00856843|Secondary|Assessment of Residual Stool - Descending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752784|NCT00856843|Secondary|Assessment of Residual Stool - Transverse Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752785|NCT00856843|Secondary|Assessment of Residual Stool - Ascending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752786|NCT00856843|Secondary|Assessment of Residual Stool - Cecum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
2752787|NCT00856843|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.|2 days||||percentage of participants|||Number
2752788|NCT00856830|Secondary|Progression Free Survival|Using the Response Evaluation Criteria in Solid Tumors (RECIST 2000), progression is defined as 20% or greater increase from the baseline tumor parameters or new lesions.|7 months||||months||95% Confidence Interval|Median
2752789|NCT00856830|Primary|Number of Patients With Adverse Events - Phase II|The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.|9 weeks||||participants|||Number
2752790|NCT00856830|Primary|Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I|The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia >5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade >2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).|9 weeks||||participants|||Number
2752791|NCT00856791|Secondary|Number of Adverse Events|The number of adverse events and their severity rating will be classified according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0.|6 months||||Adverse event|||Number
2752792|NCT00856791|Primary|Progression Free Survival|Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 months||||day|||Number
2752793|NCT00856778|Secondary|Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra||At implant||||percentage of responses|||Number
2752794|NCT00856778|Secondary|Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies||At implant||||percentage of responses|||Number
2752795|NCT00856778|Secondary|Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward||At implant||||percentage of responses|||Number
2752796|NCT00856778|Secondary|Assess Change in Pad Use||12 months post-implant||||pads/24 hours||Standard Deviation|Mean
2752797|NCT00856778|Secondary|Assess Change in Pad Use|Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.|Baseline|There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use.|||pads/24 hours||Standard Deviation|Mean
2752798|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant||||units on a scale||Standard Deviation|Mean
2752899|NCT00856388|Secondary|Acute GVHD Grade III-IV|"Acute GVHD grade III-IV~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to day 100|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2752799|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment.|||units on a scale||Standard Deviation|Mean
2752800|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant||||units on a scale||Standard Deviation|Mean
2752801|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment.|||units on a scale||Standard Deviation|Mean
2752802|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|12 months post implant|There are 73 subjects with outcome 4 (ICIQ at 12 months). Of the 74 subjects with 12 months follow-up, 1 is missing the 12 month ICIQ assessment.|||units on a scale - ICIQ Score||Standard Deviation|Mean
2752803|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|Baseline|There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment.|||units on a scale - ICIQ Score||Standard Deviation|Mean
2752804|NCT00856778|Primary|Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).|"Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding very much better or much better."|12 months|"The study was not fully enrolled and therefore underpowered for the planned analyses.~There are 71 subjects with outcome 2 (pad weight endpoint). Of the 74 with 12 months follow-up, 3 are missing the pad weight improvement assessment."|||% of subjects successful||95% Confidence Interval|Number
2752805|NCT00856778|Primary|Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)|"Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding very much better or much better."|12 months post implant|The study was not fully enrolled and therefore underpowered for the planned analyses.|||% of subjects successful||95% Confidence Interval|Number
2752806|NCT00856739|Primary|Cartilage Thickness|Medial/lateral thickness ratio|baseline or first and only visit.|Overweight and obese were combined based on similarities found in literature. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.|||mm/mm||Standard Deviation|Mean
2752807|NCT00856739|Primary|Gait Knee Adduction Moment||baseline or first and only visit.|Obese were compared to healthy weight subjects. No overweight subjects were used in this analysis. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.|||percent body weight (N)*height (m)||Standard Deviation|Mean
2752808|NCT00856726|Secondary|Fractional Excretion of Calcium|change in urinary fractional excretion of calcium from baseline to six hours|six hours|adult volunteers|||percentage of fractional excretion||Standard Deviation|Mean
2752809|NCT00856726|Secondary|Parathyroid Hormone|change in parathyroid hormone from baseline to six hours|six hours|adult volunteers|||pg/ml||Standard Deviation|Mean
2752810|NCT00856726|Secondary|Serum Calcium|change in serum calcium from baseline to six hours|six hours|adult volunteers|||mg/dL||Standard Deviation|Mean
2752811|NCT00856726|Secondary|Serum Phosphorus|change in serum phosphorus from baseline to six hours|six hours|adult volunteers|||mg/dL||Standard Deviation|Mean
2752812|NCT00856726|Secondary|Fibroblast Growth Factor 23|The change in fibroblast growth factor 23 concentrations from baseline to six hours|six hours|adult volunteers|||relative units (RU)/ml||Standard Deviation|Mean
2752813|NCT00856726|Primary|Urinary Phosphorus Excretion|Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)|six hours||||percentage of fractional excretion||Standard Deviation|Mean
2752814|NCT00856661|Secondary|Modified Ranking Scale Score (Using the Ordinal Scale)|Please see outcomes measure one for detailed description of the mRS scale|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Scores on a scale||Standard Error|Least Squares Mean
2752815|NCT00856661|Secondary|Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)|Please see outcomes measure one and two for detailed description of the scales|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Percentage of participants|||Number
2752816|NCT00856661|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)|The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.|90 days|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Percentage of participants|||Number
2752817|NCT00856661|Primary|Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)|The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Percentage of participants|||Number
2752818|NCT00856635|Secondary|To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.||6 months|Enrollment did not meet expectations, and target sample sizes were not met. As a results, the secondary outcome was not analyzed. There were no data collected for this outcome; there is no data to analyze.||||||
2752819|NCT00856635|Primary|Retinal Nerve Fiber Layer Thickness at Baseline and Month 6|Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.|Baseline and Month 6|The modified ITT intent-to-treat (mITT) analysis set included all patients who had been randomized to the study, received at least one dose of study drug, had a baseline OCT evaluation, and had at least one non-missing post-baseline OCT evaluation.|||µm||Standard Deviation|Mean
2752820|NCT00856609|Secondary|Body Weight|Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.|5 weeks||||kg||Standard Deviation|Mean
2752821|NCT00856609|Primary|Twenty-four-hour Energy Expenditure|Change of twenty-four-hour energy expenditure between at Day 5 at baseline assessment and at Day 11 two days after starting study medication between the exenatide and placebo groups|Day 5 and Day 11||||kcal/day||Standard Deviation|Mean
2752822|NCT00856609|Primary|Energy Intake|Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups|Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)||||kcal/day||Standard Deviation|Mean
2752823|NCT00856583|Secondary|Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure|The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
2752824|NCT00856583|Secondary|Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease|The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
2752825|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA|The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
2752826|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC|"The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
2752827|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
2752900|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics."|Day 100|All treated and eligible patients, who were able to complete testing|||percentage of participants|||Number
2752828|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
2752829|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
2752830|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
2752831|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
2752832|NCT00856583|Primary|Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation|Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
2752833|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
2752834|NCT00856583|Primary|Number of Participants With All-cause Mortality|The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
2752835|NCT00856557|Secondary|Rate of Contextual Planning|Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings|During initial patient recordings||||proportion of physician's patients||Standard Deviation|Mean
2752836|NCT00856557|Secondary|Rate of Contextual Probing|Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.|During initial patient recordings||||proportion of physician's patients||Standard Deviation|Mean
2752837|NCT00856557|Primary|Health Outcome Improvement Rate|A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.|After 9 months of the recorded visit||||proportion of physician's patients||Standard Deviation|Mean
2752838|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752839|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752840|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each group respectively.|||hours per day||Standard Deviation|Mean
2752841|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||hours per day||Standard Deviation|Mean
2752842|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.|||days||Standard Deviation|Mean
2752843|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||days||Standard Deviation|Mean
2752844|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each group respectively.|||events||Standard Deviation|Mean
2752845|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||events||Standard Deviation|Mean
2752846|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.|||units on a scale||Standard Deviation|Mean
2752847|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752856|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2752848|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.|||units on a scale||Standard Deviation|Mean
2752849|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752850|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
2752851|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Patient global assessment of arthritis: participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
2752852|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752853|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752854|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752855|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752895|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Subject Assessment|"The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study|||Number of Days||Standard Deviation|Mean
2752857|NCT00856544|Secondary|Medical Outcome Study (MOS) Sleep Scale at Month 12|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752858|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||participants|||Number
2752859|NCT00856544|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752860|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752861|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752862|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
2752863|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
2752864|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
2752865|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
2752866|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
2752867|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
2752868|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752869|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2752870|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6, 12|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).||||||
2752871|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).||||||
2752872|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752873|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752874|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2752875|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2752901|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics."|Day 30|All treated and eligible patients, who were able to complete testing|||percentage of participants|||Number
2752876|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2752877|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
2752878|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2752879|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
2752880|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
2752881|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
2752882|NCT00856544|Primary|Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2752883|NCT00856544|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2752896|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Physician Assessment|"The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study|||Number of Days||Standard Deviation|Mean
2752884|NCT00856544|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.|||percentage of participants|||Number
2752885|NCT00856518|Primary|Swallow-related Quality of Life (SWAL-QOL)|The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%).|at baseline and after 5-week of EMST exercise|Out of the total 42 recruited study participants, ten either did not show up for the SWAL-QOL test or only partially answered the questionnaire. Thus, 32 remaining participants (n = 19 for EMST, and n = 13 for Sham) were reported.|||percentage of possible perfect score||Standard Deviation|Mean
2752886|NCT00856518|Primary|Penetration-Aspiration Scale Score|"The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include normal to mild (1-2), moderate (3-5) and severe (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis."|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 8 failed to complete the PAS test either at baseline or post training testing. Therefore, 34 subjects were reported for the PAS test (n = 20 for EMST, n = 14 for sham).|||percentage of group participants|||Number
2752887|NCT00856518|Primary|Maximum Expiratory Pressure (MEP)|Expiratory pressure generating capacity assessed via handheld manometer.|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 6 withdrew following the baseline MEP testing, citing travel or loss of interest as the reason. Therefore, 36 subjects were reported for the MEP test (n = 20 for EMST, n = 16 for sham).|||cm H2O||Standard Deviation|Mean
2752888|NCT00856492|Secondary|Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment|||Participants|||Number
2752889|NCT00856492|Secondary|Event-free Survival|Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.|Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab|||participants|||Number
2752890|NCT00856492|Secondary|Overall Survival|Time from registration to death due to any cause|Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab|||deaths|||Number
2752891|NCT00856492|Primary|Number of Patients With Pathological Complete Response Rate|Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.|pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab|||Participants|||Count of Participants
2752892|NCT00856414|Secondary|Percentage of Patients Reporting Self-Perception of Age (SPA)|"Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were Looking younger, Looking current age, and Looking older. Results for each response are presented for Baseline and Day 14."|Baseline, Day 14|Intent to Treat defined as all patients who started the study|||Percentage of patients|||Number
2752893|NCT00856414|Secondary|Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score|Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.|Baseline, Day 14|Intent to Treat defined as all patients who started the study|||Scores on a Scale||Standard Deviation|Mean
2752894|NCT00856414|Secondary|Average Subject Assessment Score in Improvement of Appearance of Frown Lines|Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.|14 Days|Intent to Treat defined as all patients who started the study|||Scores on a Scale||Standard Deviation|Mean
2752897|NCT00856388|Secondary|3 yr Overall Survival|3 yr Overall Survival estimated using the Kaplan-Meier method.|Up to 4.5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2752905|NCT00856349|Secondary|Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization|Characterization of shock reduction programming utilization by subject characteristics and geographical regions|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.|||percentage of participants|||Number
2752906|NCT00856349|Secondary|Barriers to Utilization of Shock Reduction Programming|Characterization of barriers to physician utilization of shock reduction programming|24 months follow-up visit|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||% of subjects not programmed to target|Participants||Number
2752907|NCT00856349|Secondary|Actions Taken Following a Shock|Characterization of actions taken by the subject immediately following a device shock|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||percentage of subjects with shocks|Participants||Number
2752908|NCT00856349|Secondary|Reasons for Inappropriate Shocks|Reasons for inappropriate shocks observed during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||percentage of inappropriate shocks|Participants||Number
2752909|NCT00856349|Secondary|Lead Integrity Alert (LIA) Performance|Causes for LIA triggers reported during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||percentage of subjects with LIA triggers|Participants||Number
2752910|NCT00856349|Primary|Change in Shock Reduction Programming Adoption|"Change in percentage of subjects programmed to evidence-based target from baseline (pre-TPR distribution) to last follow-up (post-TPR distribution).~Shock-reduction programming parameters:~LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.~SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.~VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.~VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.~Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.~PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds."|Overall study (20 months on average)|Subjects with paired baseline and follow-up programming data|||percentage of participants|||Number
2752911|NCT00856323|Secondary|Post-Exposure Prophylaxis Medication Adherence|Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).|28-days|35 participants initiated PEP|||proportional medication adherence||Inter-Quartile Range|Median
2752912|NCT00856323|Secondary|HIV-related Sexual Risk Behaviors in Previous 30 Days.|Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.|3-months after baseline|53 enrolled and 2 were withdrawn.|||episodes||Standard Deviation|Mean
2752913|NCT00856323|Secondary|Description of Incident STI Infections.|Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.|Baseline and 3-months|53 enrolled and 2 were withdrawn.|||Proportion of Participants||Full Range|Mean
2752914|NCT00856323|Primary|Self-reported Methamphetamine Use in Previous 30 Days.|Mean number of days (of the past 30) of methamphetamine use.|3-months after baseline|53 enrolled and 2 were withdrawn.|||days||Standard Deviation|Mean
2752915|NCT00856297|Secondary|Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.|28 days postvaccination|Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up.|||subjects|||Number
2752916|NCT00856297|Secondary|Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator|Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.|Day 1 to 5 years|Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases.|||subjects|||Number
2752917|NCT00856297|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events|Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.|Day 1 to Day 7|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||subjects|||Number
2752918|NCT00856297|Secondary|Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.|||titers||95% Confidence Interval|Geometric Mean
2752919|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
2752920|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine|Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|1 month post booster vaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
2752921|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination|Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.|||titers||95% Confidence Interval|Geometric Mean
2752922|NCT00856297|Secondary|Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8|Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
2752923|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.|||titers||95% Confidence Interval|Geometric Mean
2752924|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
2752925|NCT00856297|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
2752926|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104|The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 104|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward was used (LOCF).|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2752927|NCT00856284|Secondary|Change From Baseline in Body Weight Over Time|LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.|Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, LOCF was used.|||kg||Standard Error|Least Squares Mean
2752928|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2752929|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2752930|NCT00856284|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug who had a Baseline assessment and at least 1 post-baseline assessment for FPG. LOCF was used.|||mg/dL||Standard Error|Least Squares Mean
2752995|NCT00855738|Secondary|Percent of Participants Who Continued on Study Medication to Month 6|Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.|Baseline to Month 6|FAS; LOCF.|||percent of participants|||Number
2752931|NCT00856284|Secondary|Change From Baseline in Glycosylated Hemoglobin at Other Time Points|The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.|Per-protocol set; LOCF was used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2752932|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 52|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward (LOCF) was used.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2752933|NCT00856245|Secondary|Progression Free Survival (PFS) and Overall Survival (OS)|Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.|up to 60 months|Of the 14 patients that had harvestable cells, 3 chose to delay transplant. The remaining 11 patients underwent Autologous stem cell transplantation (Auto-SCT).|||months||Full Range|Median
2752934|NCT00856245|Primary|Rate of PCR Negativity|Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.|up to 7 days|21 patients were initially enrolled; 2 were withdrawn after signing informed consent per physician decision. Of the remaining 19: 5 did not have harvestable stem cells; 14 completed stem cell collection and PCR evaluation.|||Participants|||Count of Participants
2752935|NCT00856232|Primary|Time to Relief (Min)|Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.|study duration||||Minutes||Standard Deviation|Mean
2752936|NCT00856232|Secondary|Length of Stay in the Emergency Department(Min)|Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department.|Study duration||||Minutes||Standard Deviation|Mean
2752937|NCT00856206|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flare Days||Standard Deviation|Mean
2752938|NCT00856206|Secondary|Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
2752939|NCT00856206|Secondary|Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
2752940|NCT00856206|Secondary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flares||Standard Deviation|Mean
2752977|NCT00855868|Primary|Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.|Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.|28 d||||SUVR||Standard Deviation|Mean
2752941|NCT00856206|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 20|Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received.|||percentage of participants|||Number
2752942|NCT00856193|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)|According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.|Day 14|Safety Population|||Participants|||Number
2752943|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 12 hours-24 hours after drug administration on Day 14|Efficacy analysis set|||Liters||Standard Error|Least Squares Mean
2752944|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From day 1 to 0 -12 hours after drug administration on Day 14|Efficacy analysis set|||Liters||Standard Error|Least Squares Mean
2752945|NCT00856193|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 0-24 hours after drug administration on Day 14|Efficacy analysis set|||Liters||Standard Error|Least Squares Mean
2752946|NCT00856180|Secondary|Overall Survival (OS)|OS estimated using Kaplan-Meier methods is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median follow-up was 23 months in this study cohort.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
2752947|NCT00856180|Secondary|Progression-Free Survival (PFS)|PFS estimated using Kaplan-Meier methods is defined as the duration of time from the start of bevacizumab alone to documented disease progression (PD) requiring removal from the study or death. If participant ultimately received both bevacizumab and cyclophosphamide then it was the time until PD on both agents. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA-125 that rises to >/=2xULN documented, both requiring 2nd confirmation. Participants who were event-free were censored at the date of their last disease evaluation.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment and every 3 months in follow-up until PD, death or lost to follow-up. Median treatment duration was 7.5 months (range 0.7-20.7) and survival follow-up 23 months..|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
2752948|NCT00856180|Secondary|Clinical Benefit Response Rate|Clinical benefit response rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.|||proportion of participants||90% Confidence Interval|Number
2752949|NCT00856180|Primary|Grade 3-5 Gastrointestinal Perforation|All grade 3-5 gastrointestinal perforation events based on CTCAEv3 as reported on case report forms.|Assessed each cycle/3 weeks throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.|||proportion of participants||90% Confidence Interval|Number
2752968|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 24 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2752978|NCT00855842|Primary|Length of Medical Abortion|This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus|hours since the start of medical abortion||||hours||Standard Deviation|Mean
2752950|NCT00856180|Primary|Therapy Completion Rate|The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to >/=2xULN documented, both requiring 2nd confirmation.|Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.|||proportion of participants||80% Confidence Interval|Number
2752951|NCT00856050|Primary|Progression Free Survival Rate at 12 Weeks|Data below are reported as progression free rate (%).|12 weeks|27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
2752952|NCT00856024|Secondary|Percent of Participants Who Achieved Early Virologic Response (EVR)|EVR was defined as HCV RNA negative after 12 weeks of treatment.|Week 12|Number of participants with data|||Percent of participants||95% Confidence Interval|Number
2752953|NCT00856024|Secondary|Percent of Participants Who Achieved Rapid Virologic Response (RVR)|RVR was defined as HCV RNA negative after 4 weeks of treatment.|Week 4|Number of participants with data|||Percent of participants||95% Confidence Interval|Number
2752954|NCT00856024|Primary|Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks|The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.|First 12 weeks of treatment|All enrolled participants|||Percent of participants||95% Confidence Interval|Number
2752955|NCT00855959|Secondary|Number of Participants With Adverse Events (AEs)|Number of participants with AEs reported during the period on Pulmicort Respules|6 weeks||||Participants|||Number
2752956|NCT00855959|Secondary|Forced Vital Capacity (FVC)|Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L||Standard Deviation|Mean
2752957|NCT00855959|Secondary|Forced Expiratory Volume in 1 Second (FEV 1.0)|Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L||Standard Deviation|Mean
2752958|NCT00855959|Secondary|Night-time Awakenings Due to Asthma Symptoms|Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||awakenings||Standard Deviation|Mean
2752959|NCT00855959|Secondary|Use of Rescue Medication (Total)|Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||puffs||Standard Deviation|Mean
2752960|NCT00855959|Secondary|Use of Rescue Medication (Night-time)|Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||puffs||Standard Deviation|Mean
2752961|NCT00855959|Secondary|Use of Rescue Medication (Daytime)|Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||puffs||Standard Deviation|Mean
2752962|NCT00855959|Secondary|Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||Scores on a scale||Standard Deviation|Mean
2752963|NCT00855959|Secondary|Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||Scores on a scale||Standard Deviation|Mean
2752964|NCT00855959|Secondary|Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||Scores on a scale||Standard Deviation|Mean
2752965|NCT00855959|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L/min||Standard Deviation|Mean
2752966|NCT00855959|Primary|Morning Peak Expiratory Flow (mPEF)|Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L/min||Standard Deviation|Mean
2752967|NCT00855933|Primary|Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale|"A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).~For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit."|4 weeks||||units on a scale||Standard Error|Mean
2752969|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 48 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2752970|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 72 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2752971|NCT00855920|Primary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).|Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends|Full analysis set (FAS) that included of all randomized participants who received any study drug and had at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2752972|NCT00855894|Secondary|Percentage of Patients With Disease Control (DC) at Day 56|DC was defined as a CR, a PR, or stable disease (SD) as determined by the investigator and based on CT using RECIST. A CR was defined as the disappearance of all target (TL) and non-target lesions (nTL). A PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline sum longest diameter, or the persistence of 1 or more nTLs and/or maintenance of a tumor marker level (TML) above normal limits. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (SSLD) since treatment started. For nTLs, SD was defined as the persistence of 1 or more lesions and/or maintenance of a TML above normal limits. PD was defined as ≥ 20% increase in the SLD of TLs, taking as reference the SSLD recorded since treatment started, the appearance of 1 or more new lesions, or the unequivocal progression of existing nTLs.|Baseline to Day 56|All 41 patients treated with erlotinib and pertuzumab.|||Percentage of patients||95% Confidence Interval|Number
2752973|NCT00855894|Secondary|Percentage of Patients With an Objective Response (OR)|OR was defined as a complete response (CR) or a partial response (PR) as determined by the investigator and based on computed tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) on 2 consecutive occasions at least 4 weeks apart. A complete response was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. A partial response was defined as ≥ 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or the persistence of 1 or more non-target lesions and/or the maintenance of a tumor marker level above the normal limits.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab.|||Percentage of patients||95% Confidence Interval|Number
2752974|NCT00855894|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of first dosing with pertuzumab and erlotinib until the date of patient death from any cause.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not died at the time of analysis for OS were censored at the date of last contact.|||Months||95% Confidence Interval|Median
2752975|NCT00855894|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dosing with pertuzumab and erlotinib to the first occurrence of disease progression (PD), as determined by the investigator and based on computed tomography using Response Evaluation Criteria in Solid Tumors (RECIST), or death from any cause, whichever comes first. PD was defined as ≥ 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started, the unequivocal progression of existing non-target lesions (non-TL), or the appearance of 1 or more new lesions. TLs were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as TLs. All other lesions (or sites of disease) were identified as non-TLs.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not progressed or died at the time of analysis for PFS were censored at the date of their last tumor assessment.|||Months||95% Confidence Interval|Median
2752976|NCT00855894|Primary|Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups|The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.|Baseline to Day 56|All 41 patients treated with pertuzumab and erlotinib were evaluable for analysis. Patients with a missing Day 56 assessment were deemed non-responders. Tumor tissue samples were only available for 32 patients for EGFR mutation status analysis.|||Percentage of patients||95% Confidence Interval|Number
2752979|NCT00855816|Primary|Change Scores for Criteria D Items on the CAPS Structured Clinical Interview|"Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment.~Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms.~Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms.~Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement)."|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2752980|NCT00855738|Secondary|Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit|Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).|Month 6|FAS; LOCF.|||percent of participants|||Number
2752981|NCT00855738|Secondary|Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy|Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.|||Days||Standard Deviation|Mean
2752982|NCT00855738|Secondary|Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy|Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.|Baseline to Month 6|FAS; LOCF. Costs involved in health and non-health resources needed during the study were not analyzed as planned with this endpoint. N=number of subjects with visits to a specialist because of epilepsy.|||visits||Standard Deviation|Mean
2752983|NCT00855738|Secondary|Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)|MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night.|Baseline, Month 6|FAS; LOCF.|||percent of participants|||Number
2752984|NCT00855738|Secondary|Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)|Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night).|Baseline to Month 6|FAS LOCF. Change from baseline in Optimal sleep is not shown as changes from baseline were only evaluated for continuous parameters. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
2752985|NCT00855738|Secondary|Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)|Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 3, Month 6|FAS LOCF. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
2752986|NCT00855738|Secondary|Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)|QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
2752987|NCT00855738|Secondary|Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)|HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
2752988|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy||Baseline through Month 6 (or end of treatment)|FAS; LOCF. N= number of subjects with initial treatment administered as monotherapy.|||percent of participants|||Number
2752989|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)||Baseline to Month 6 (or end of treatment)|FAS; LOCF.|||percent of participants||95% Confidence Interval|Number
2752990|NCT00855738|Secondary|Percent of Participants Reaching Monotherapy|Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.|Baseline through Month 6 (or end of study)|FAS; LOCF. N=number of participants who started on bitherapy.|||percent of partipants||95% Confidence Interval|Number
2752991|NCT00855738|Secondary|Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)|Patient Global Impression of Change VAS: subject rated instrument to measure subject's change in overall status; range from 0 (much better) to 10 (much worse).|Baseline, Month 3, Month 6|FAS; LOCF. The scale for this endpoint was not collected and results were not analyzed as planned.|||scores on scale||Standard Deviation|Mean
2752992|NCT00855738|Secondary|Time to Discontinuation Due to Other Reasons||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to other reasons, the time to exit analyses was not performed.|||days||Full Range|Median
2752993|NCT00855738|Secondary|Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to safety, tolerability or compliance with treatment, the time to exit analysis was not performed.|||days||Inter-Quartile Range|Median
2752997|NCT00855738|Secondary|Percent of Days Without Crisis During the Study|Crisis was defined as the total number of seizures during the study, the seizures at month 3 plus the seizures at month 6. The percent of days without crisis is number of days of study (date of last visit minus date of baseline visit) without crisis divided by number of days of study, multiplied by 100.|Baseline through Month 6 (or end of treatment)|The percentage of days without crisis during the study was not evaluable because a diary with the daily number of crises was not collected.|||percentage of days|||Number
2752998|NCT00855738|Secondary|Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS LOCF. N=number of subjects with evaluable data.|||percent change||Inter-Quartile Range|Median
2752999|NCT00855738|Secondary|Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.|||percent of participants||95% Confidence Interval|Number
2753000|NCT00855738|Secondary|Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment|Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit.|Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.|||percent of participants||95% Confidence Interval|Number
2753001|NCT00855738|Primary|Percent of Participants Classified as Responders|Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).|Baseline, Month 3, Month 6 (last 3 months of treatment)|Full Analysis Set (FAS): intent-to-treat population = those who took at least 1 dose of study medication and had post-baseline data for at least 1 efficacy endpoint. Last Observation Carried Forward (LOCF) captures last 3 months of treatment for subjects who discontinued between Month 3 and Month 6 only. N=number of subjects with evaluable data.|||percent of participants||95% Confidence Interval|Number
2753002|NCT00855595|Other Pre-specified|Patient Opinion of Local Tolerability||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of Participants|||Number
2753003|NCT00855595|Secondary|Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of participants|||Number
2753004|NCT00855595|Secondary|Patient Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of participants|||Number
2753005|NCT00855595|Secondary|Investigator Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of participants|||Number
2753006|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 12|FAS|||Percentage of participants|||Number
2753007|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 8|FAS|||Percentage of participants|||Number
2753008|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 6|FAS|||Percentage of participants|||Number
2753009|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 4|FAS|||Percentage of participants|||Number
2753010|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 2|FAS|||Percentage of participants|||Number
2753011|NCT00855595|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)|Weeks 2, 4, 6, 8 and 12|FAS|||Percentage of participants|||Number
2753012|NCT00855595|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).|Weeks 2, 4, 6, 8 and 12|FAS|||Percentage of participants|||Number
2753013|NCT00855595|Secondary|Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)||Baseline and Weeks 2, 4, 6, 8 and 12|FAS|||Percentage of participants|||Number
2753014|NCT00855595|Secondary|Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2, 4, 6, 8 and 12|FAS|||Percent of inflammatory lesions||Standard Deviation|Mean
2753015|NCT00855595|Secondary|Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 4, 6, 8 and 12|FAS|||Inflammatory lesions||Standard Deviation|Mean
2753016|NCT00855595|Secondary|Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)||Week 2, 4, 6, 8 and 12|FAS|||Inflammatory lesions||Standard Deviation|Mean
2753017|NCT00855595|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2|Full analysis set (FAS)|||Inflammatory lesions||Standard Deviation|Mean
2753018|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint|Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||mL||Standard Deviation|Mean
2753019|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint|Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||mL/sec||Standard Deviation|Mean
2753020|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint|Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||mL/sec||Standard Deviation|Mean
2753021|NCT00855582|Secondary|Erectile Function General Assessment Questionnaire (EF-GAQ)|The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.|12 weeks|Participants started study medication, and had non-missing data.|||participants with yes response|||Number
2753022|NCT00855582|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint|A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.|||participants|||Number
2753023|NCT00855582|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint|A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.|||participants|||Number
2753024|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
2753025|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
2753026|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
2753027|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint|IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753118|NCT00855413|Secondary|Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and Week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
2753028|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint|IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753029|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint|Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
2753030|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint|Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
2753031|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint|Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753032|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12|The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753033|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753034|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753035|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753036|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
2753097|NCT00855413|Secondary|Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48|Change in overall z score from baseline to week 24 or 48. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Baseline to Week 24 or 48|Participants who underwent neurocognitive assessment at baseline and Week 24 and/or 48.|||z score||Standard Deviation|Mean
2753037|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753038|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753039|NCT00855582|Secondary|Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint|The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 2 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753040|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
2753041|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
2753042|NCT00855582|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on scale||Standard Error|Least Squares Mean
2753043|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of Yes responses||Standard Error|Least Squares Mean
2753044|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753055|NCT00855465|Other Pre-specified|Oxygen Saturation (SaO2) - Change From Baseline to Week 16|Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.|||Percentage of oxygen saturation||Standard Deviation|Mean
2753045|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753046|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753047|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2753048|NCT00855465|Other Pre-specified|Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16|Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||beats per minute (bpm)||Standard Deviation|Mean
2753049|NCT00855465|Other Pre-specified|Mean RR Duration (RRmean) - Change From Baseline to Week 16|RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
2753050|NCT00855465|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
2753051|NCT00855465|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
2753052|NCT00855465|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Week 16|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
2753053|NCT00855465|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Week 16|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
2753054|NCT00855465|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Week 16|PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
2753069|NCT00855465|Other Pre-specified|Creatine Kinase (CK) - Change From Baseline to Week 16|Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
2753056|NCT00855465|Other Pre-specified|Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16|Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.|||mmHg||Standard Deviation|Mean
2753057|NCT00855465|Other Pre-specified|Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16|Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.|||mmHg||Standard Deviation|Mean
2753058|NCT00855465|Other Pre-specified|Triacylglycerol Lipase - Change From Baseline to Week 16|Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
2753059|NCT00855465|Other Pre-specified|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||ng/ml||Standard Deviation|Mean
2753060|NCT00855465|Other Pre-specified|Urea (BUN) - Change From Baseline to Week 16|Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
2753061|NCT00855465|Other Pre-specified|Urate - Change From Baseline to Week 16|Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
2753062|NCT00855465|Other Pre-specified|Potassium - Change From Baseline to Week 16|Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mmol/L||Standard Deviation|Mean
2753063|NCT00855465|Other Pre-specified|Hematocrit - Change From Baseline to Week 16|Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||Volume percentage of red blood cells||Standard Deviation|Mean
2753064|NCT00855465|Other Pre-specified|Hemoglobin - Change From Baseline to Week 16|Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||g/dL||Standard Deviation|Mean
2753065|NCT00855465|Other Pre-specified|Neutrophils - Change From Baseline to Week 16|Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^9 cells/L||Standard Deviation|Mean
2753066|NCT00855465|Other Pre-specified|Lymphocytes - Change From Baseline to Week 16|Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^9 cells/L||Standard Deviation|Mean
2753067|NCT00855465|Other Pre-specified|Leukocytes (WBC) - Change From Baseline to Week 16|Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^9 cells/L||Standard Deviation|Mean
2753068|NCT00855465|Other Pre-specified|Erythrocytes (RBC) - Change From Baseline to Week 16|Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^12 cells/L||Standard Deviation|Mean
2753070|NCT00855465|Other Pre-specified|Creatinine Clearance - Change From Baseline to Week 16|Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mL/min||Standard Deviation|Mean
2753071|NCT00855465|Other Pre-specified|Creatinine - Change From Baseline to Week 16|Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
2753072|NCT00855465|Other Pre-specified|Bilirubin - Change From Baseline to Week 16|Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
2753073|NCT00855465|Other Pre-specified|Alkaline Phosphatase (AP) - Change From Baseline to Week 16|Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
2753074|NCT00855465|Other Pre-specified|Aspartate Aminotransferase (AST) - Change From Baseline to Week 16|Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
2753075|NCT00855465|Other Pre-specified|Alanine Aminotransferase (ALT) - Change From Baseline to Week 16|Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
2753076|NCT00855465|Other Pre-specified|Heart Rate (HR) - Change From Baseline to Week 16|Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.|||Beats/min||Standard Deviation|Mean
2753077|NCT00855465|Other Pre-specified|Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16|Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.|||mmHg||Standard Deviation|Mean
2753078|NCT00855465|Other Pre-specified|Systolic Blood Pressure (SBP) - Change From Baseline to Week 16|Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 - 180 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.|||mmHg||Standard Deviation|Mean
2753079|NCT00855465|Other Pre-specified|Cardiac Index (CI) - Change From Baseline to Week 16|The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject's height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2)|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of CI."|||L/min/m^2||Standard Deviation|Mean
2753080|NCT00855465|Other Pre-specified|Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PAPmean."|||mmHg||Standard Deviation|Mean
2753081|NCT00855465|Other Pre-specified|All Caused Mortality|"All cause mortality (including cardiovascular mortality) was one component of the composite endpoint time to clinical worsening."|At visit 6 (week 16)|Intent to Treat (ITT) - a randomized subject was valid for ITT analyses if at least one dose of study medication was administered.|||Participants|||Number
2753082|NCT00855465|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.|||Scores on a scale||Standard Deviation|Mean
2753116|NCT00855413|Secondary|Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
2753083|NCT00855465|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.|||Scores on a scale||Standard Deviation|Mean
2753084|NCT00855465|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (Extremely strong - Maximal)."|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Scores on a scale||Standard Deviation|Mean
2753085|NCT00855465|Secondary|Percentage of Participants With Clinical Worsening|"The combined endpoint time to clinical worsening, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH."|At week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Percentage of participants|||Number
2753086|NCT00855465|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.|||Percentage of Participants|||Number
2753087|NCT00855465|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.|||pg/mL||Standard Deviation|Mean
2753088|NCT00855465|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.|||dyn*s*cm^-5||Standard Deviation|Mean
2753089|NCT00855465|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Meters||Standard Deviation|Mean
2753090|NCT00855439|Other Pre-specified|Intra-epidermal Nerve Fiber Density|Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.|12 months|Subset of study population|||nerve fibers per mm of skin||Standard Deviation|Mean
2753091|NCT00855439|Secondary|Cardiac Autonomic Neuropathy|resting heart rate as marker of autonomic function at rest|18 month||||beats per minute||Standard Deviation|Mean
2753092|NCT00855439|Secondary|Cardiac Autonomic Neuropathy (CAN)|Group differences in E/I ratio, a measure of cardiac autonomic function.|18 months||||unit-less measure||Standard Deviation|Mean
2753093|NCT00855439|Primary|Confirmed Clinical Neuropathy (CCN)|CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve).|18 Months||||participants|||Number
2753094|NCT00855413|Secondary|HIV RNA Detection in Ileal Biopsy Specimens|Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48.|Weeks 4 and 48|Study stopped prior to target enrollment by sponsor. Given insufficient ileal biopsy samples, correlation of HIV viremia in ileal biopsies with time to suppression was not performed due to inadequate power to analyze the outcome.|||copies/mL||Full Range|Mean
2753095|NCT00855413|Secondary|Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48||Baseline to Week 24 and 48|Participants who consented to optional neurocognitive assessments at baseline and week 24 or 48|||r value|||Number
2753096|NCT00855413|Secondary|Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning||From enrollment through Week 48|Participants who consented to neurocognitive assessments at baseline and week 24 or 48. Sponsor stopped study prior to target enrollment.|||r value|||Number
2753117|NCT00855413|Secondary|Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
2753098|NCT00855413|Secondary|Overall Neurocognitive Impairment at Week 48|Neuropsychological performance was assessed at baseline (week 2 or 4), week 24 and week 48 in the following domain (measures): Premorbid/language (Wide Range Achievement Test (WRAT) 4 - Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 48|participants who underwent neurocognitive assessment at baseline and week 48|||z score||Standard Deviation|Mean
2753099|NCT00855413|Secondary|Overall Neurocognitive Impairment at Week 24|Neuropsychological performance was assessed at week 2 or 4, week 24 and week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 24|participants who underwent neurocognitive assessment at baseline and week 24|||z score||Standard Deviation|Mean
2753100|NCT00855413|Secondary|Overall Neurocognitive Impairment Score at Week 2 or 4|Neuropsychological performance was assessed at Week 2 or 4, Week 24 and Week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test-Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 2 or 4|participants who underwent neurocognitive assessment at week 2 or 4|||z score||Standard Deviation|Mean
2753101|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Week 48||Week 48|Participants who consented to optional procedure of neurocognitive assessment at week 48|||Participants|||Count of Participants
2753102|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Week 24||Week 24|Participants who consented to optional procedure of neurocognitive assessment at week 24|||Participants|||Count of Participants
2753103|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Baseline||Week 2 or 4|Participants who consented to optional procedure of neurocognitive assessment at baseline|||Participants|||Count of Participants
2753104|NCT00855413|Secondary|Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid||Week 4 and Week 48|Four participants provided 7 CSF samples for measurement of HIV RNA level|||participants|||Number
2753105|NCT00855413|Secondary|Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
2753106|NCT00855413|Secondary|Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
2753107|NCT00855413|Secondary|Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
2753108|NCT00855413|Secondary|Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
2753109|NCT00855413|Secondary|Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
2753110|NCT00855413|Secondary|Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
2753111|NCT00855413|Secondary|Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and Weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
2753112|NCT00855413|Secondary|Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and Weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
2753113|NCT00855413|Secondary|Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
2753114|NCT00855413|Secondary|Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
2753115|NCT00855413|Secondary|Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
2753119|NCT00855413|Secondary|Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
2753120|NCT00855413|Secondary|Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
2753121|NCT00855413|Secondary|Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|4 participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
2753122|NCT00855413|Secondary|Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels.|||ng/mL|||Number
2753123|NCT00855413|Secondary|Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48|Total number of adverse events observed that were possibly or definitely related to study treatment through week 48|Enrollment to week 48||||adverse events|||Number
2753124|NCT00855413|Secondary|Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance||Enrollment to Week 48||||Participants|||Count of Participants
2753125|NCT00855413|Secondary|HIV RNA Detection in Semen|Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.|From enrollment through 48 weeks|Study stopped prior to target enrollment by sponsor. Given insufficient semen samples, correlation of HIV viremia in semen with time to suppression was not performed due to inadequate power to analyze the outcome.|||copies/mL||Full Range|Mean
2753126|NCT00855413|Secondary|Median Time to HIV RNA Suppression to <200 Copies/mL||From enrollment to the date of HIV RNA suppression, assessed up to Week 48||||days||Full Range|Median
2753127|NCT00855413|Secondary|HIV RNA Levels Immediately Prior to Initiating Study Treatment.||HIV RNA level at enrollment||||copies/mL||Full Range|Median
2753128|NCT00855413|Secondary|Median Change in CD4 Cell Count From Week 0 to Week 48.||48 weeks from enrollment|12 participants with a week 48 study visit were included in analysis|||cells/mm^3||Full Range|Median
2753129|NCT00855413|Secondary|Median Change in CD4 Cell Count From Week 0 to Week 24.||week 0, week 24|All participants enrolled were included in this analysis|||cells/mm^3||Full Range|Median
2753130|NCT00855413|Secondary|Number of Participants With Virologic Response|Virologic response to study treatment defined as plasma HIV RNA measurement <50 copies/mL at week 48|48 weeks from enrollment|All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48|||Participants|||Count of Participants
2753131|NCT00855413|Primary|Number of Participants With Virologic Response|Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24|24 weeks|All participants enrolled were included in analysis of virologic response|||Participants|||Count of Participants
2753132|NCT00855335|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to follow up period (16 weeks after postpartum)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.|||Participants|||Number
2753133|NCT00855335|Secondary|Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result|The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).|Birth to age 16 weeks|Infants population whose mothers were included in Intent-to-treat (ITT) analysis set and who were enrolled in this study and took at least one dose of study medication. 'N' signifies number of infants who were born and had HIV test data available.|||infants|||Number
2753134|NCT00855335|Secondary|Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery|The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.|On day of delivery - Intrapartum (Visit 6)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2753135|NCT00855335|Secondary|Number of Participants With Resistance at Virological Failure|Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load >1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load >200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (<=) 200 copies/mL. For participants with a baseline viral load <=200 copies/mL, virologic failure was defined as viral load of >200 copies/mL (at 2 successive visits) at any point during the study.|Up to follow-up phase (16 weeks after postpartum)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.|||Participants|||Number
2753136|NCT00855335|Secondary|Mean Change From Baseline in CD4+ Cell Count|Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.|Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signified number of participants evaluated for this outcome measure.|||10^6 Cells/Liter||Standard Error|Mean
2753149|NCT00855218|Secondary|Time to Untreatable Progression (TTUP)|Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
2753137|NCT00855335|Secondary|Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value|Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).|Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||Log 10 copies per milliliter (copies/mL)||Standard Error|Mean
2753138|NCT00855335|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)|Number of participants were assessed with a viral load (VL) lesser than (<) 50 HIV-1 RNA copies/ mL over time.|Up to postpartum (6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||Participants|||Number
2753139|NCT00855335|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)|The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2753140|NCT00855335|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)|The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2753141|NCT00855335|Primary|Time to Reach the Maximum Plasma Concentration (Tmax)|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||hour (h)||Full Range|Median
2753142|NCT00855335|Primary|Maximum Plasma Concentration (Cmax)|The Cmax is the maximum observed plasma concentration.|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2753143|NCT00855335|Primary|Minimum Plasma Concentration (Cmin)|The Cmin is the minimum observed plasma concentration.|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2753144|NCT00855335|Primary|Predose (Trough) Plasma Concentration (C0h)|C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.|Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2753145|NCT00855309|Primary|Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline||24 hours||||participants|||Number
2753146|NCT00855218|Secondary|Tumor Response - Investigator Assessment|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Participants|||Number
2753147|NCT00855218|Secondary|Tumor Response - Independent Radiological Review|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Participants|||Number
2753148|NCT00855218|Secondary|Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)|Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
2753150|NCT00855218|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
2753151|NCT00855218|Primary|Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)|TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
2753152|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)|||Percent||95% Confidence Interval|Least Squares Mean
2753153|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)|||Percent||95% Confidence Interval|Least Squares Mean
2753154|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)|||Percent||95% Confidence Interval|Least Squares Mean
2753155|NCT00855166|Secondary|Proportion of Participants With Body Weight Decrease ≥5%|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2753156|NCT00855166|Secondary|Adjusted Mean Change in Body Fat Mass|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2753157|NCT00855166|Secondary|Adjusted Mean Change in Waist Circumference|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||cm||95% Confidence Interval|Least Squares Mean
2753158|NCT00855166|Primary|Adjusted Mean Change in Total Body Weight|To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2753159|NCT00855062|Secondary|24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score|"The outcome is the total CES-D score at week 24 - the total CES-D score at baseline.~The total CES-D score is based on 20 CES-D items, such as I was bothered by things that usually don't bother me and I did not feel like eating, my appetite was poor. Patients were asked to answer each item by 4 scales: (1) Rarely, (2) Sometimes, (3) Occasionally, and (4) Most of the time. After 4 negative items were multiplied by -1, the total CES-D score is a simple sum of all items.~The min and Max are 0 and 60, respectively. Higher scores indicate more severe depressive symptoms."|At baseline and week 24|The analysis includes participants with CES-D scores at baseline and week 24.|||scores on a scale||Standard Deviation|Mean
2753160|NCT00855062|Secondary|24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)|The outcome is the HIV RNA plasma viral loads (Log10 transformed) at week 24 - the viral loads (Log10 transformed) at baseline.|At baseline and week 24|The analysis includes participants with HIV RNA viral loads at baseline and week 24.|||copies/mL||Inter-Quartile Range|Median
2753161|NCT00855062|Secondary|24-week Change of Instrumental Activities of Daily Living|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The analysis includes participants with IADL scores at baseline and week 24.|||percentage of participants|||Number
2753162|NCT00855062|Secondary|48-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 48 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 48|This analysis used the participants with CD4 cell counts at baseline and week 48.|||cells/mm^3||Standard Deviation|Mean
2753163|NCT00855062|Secondary|24-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 24 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 24|This analysis used the participants with CD4 cell counts at baseline and week 24.|||cells/mm^3||Standard Deviation|Mean
2753164|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms|The outcome is the time of first Grade ≥ 2 toxicity and/or sign and symptoms from treatment initiation up to 48 weeks. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks|This analysis includes every randomized participants. A total of 22 minocycline and 21 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 48 weeks.|||participants with an event|||Number
2754655|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2753165|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.|The outcome is the time to first Grade ≥ 2 toxicity and/or sign and symptoms from study treatment initiation up to week 24. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24|This analysis includes every randomized participants. A total of 21 minocycline and 20 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 24 weeks|||participants with an event|||Number
2753166|NCT00855062|Secondary|24-week Change of Karnofsky Performance Score|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|This analysis includes the participants with Karnofsky performance score at baseline and week 24.|||percentage of participants|||Number
2753167|NCT00855062|Secondary|24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The descriptive statistics were based on observed data. Since all participants reported there were no change in the MSK score at week 24, no statistical test was conducted.|||participants|||Number
2753168|NCT00855062|Primary|24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)|"The U NP Sum is defined as the average of z scores for 9 neuropsychological test subcomponents in the neuropsychological test battery (i.e. the average of norm-adjusted (z) scores for Grooved Pegboard Dominant Hand, Grooved Pegboard Non-dominant Hand, Color Trails 1, Color Trails 2, Symbol Digit, WHO-UCLA Verbal Learning test Trial 5, WHO-UCLA Verbal Learning test delayed recall, Digit Span forward and Digit Span backward). The outcome is defined as U NP Sum at week 24 - U NP Sum at baseline."|At baseline and week 24|The descriptive statistics are based on per protocol analysis. For the statistical analysis, ITT analysis was used and the missing U NP Sums at week 24 were imputed using a multiple regression imputation method. The number of participants analyzed for the ITT analysis was 73 (36 for Minocycline and 37 for Placebo).|||z-score||Standard Deviation|Mean
2753169|NCT00855010|Secondary|Disposition Index|Disposition index is a measure of insulin secretion multiplied by insulin sensitivity, both derived from intravenous glucose tolerance test. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose|12 months||||Unitless||Inter-Quartile Range|Median
2753170|NCT00855010|Secondary|Bone Mineral Density|Areal Bone Mineral Density at the L2-L4 antero-posterior lumbar spine, left femoral neck and total hip were measured by DXA scan using a Hologic Discovery Instrument scanner.|12 months||||g/cm^2||Standard Deviation|Mean
2753171|NCT00855010|Secondary|Visceral Fat Area|Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.|12 months||||cm^2||Standard Deviation|Mean
2753172|NCT00855010|Secondary|Subcutaneous Fat Area|Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.|12 months||||cm^2||Standard Deviation|Mean
2753173|NCT00855010|Secondary|Hepatic Fat Content|Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.|12 months||||percentage||Inter-Quartile Range|Median
2753174|NCT00855010|Secondary|Beta-cell Function|Changes in B-cell function as measured by acute insulin release to glucose (AIRg)|12 months||||microUnits/mL x min||Inter-Quartile Range|Median
2753175|NCT00855010|Primary|Bone Turnover Marker - Plasma 25-hydroxyvitamin D|Plasma 25-hydroxyvitamin D was determined by radioimmunoassay|12 months||||ng/mL||Inter-Quartile Range|Median
2753176|NCT00855010|Primary|Bone Turnover Marker - Intact Parathyroid Hormone (PTH)|Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .|12 months||||pg/mL||Inter-Quartile Range|Median
2753177|NCT00855010|Primary|Pancreatic Fat Content|Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.|12 months||||Percentage of fat||Inter-Quartile Range|Median
2753178|NCT00854906|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used in dry eye studies. The OSDI Scale ranges from 0= Normal to 100= Severe. Subcategories include problems--all of the time, most of the time, half of the time,and none of the time.|1 week|By comparing the KTBUT and the FTBUT to the Ocular Surface Disease Index (OSDI) questionnaire score of each participant, we will be able to evaluate the difference in tear break up time using these items. The OSDI was given once before the participant's KTBUT and FTBUT was measured.|||participants||Standard Deviation|Mean
2753179|NCT00854906|Primary|Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)|This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.|1 day|The number of participants for analysis was determined if each participant met all of the study protocol's inclusion and exclusion criteria. KTBUT and FTBUT were measured on all study participants.|||time in seconds|Participants|Standard Deviation|Mean
2753180|NCT00854724|Primary|Amount of Alcohol Consumed||During a 90 minute drinking session||||Number of drinks consumed||Standard Error|Mean
2753181|NCT00854620|Primary|Time-to-progression (TTP)||12 months||||months||Full Range|Median
2753182|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753321|NCT00853593|Secondary|Fluoroscopy Time|The total time the fluoroscope was imaging (not including biplane fluoroscopy time).|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported.|||minutes||Standard Deviation|Mean
2753183|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753184|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753185|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753186|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753187|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753188|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753189|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753245|NCT00853957|Secondary|Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)|Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set|||Percentage of participants|||Number
2753190|NCT00854607|Secondary|Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753191|NCT00854607|Secondary|Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753192|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
2753193|NCT00854607|Secondary|Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753194|NCT00854607|Secondary|Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753195|NCT00854607|Secondary|Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753196|NCT00854607|Primary|Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD). The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and whose clinical outcome was determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
2753246|NCT00853957|Secondary|Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)|Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set|||Percentage of participants|||Number
2753197|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the attitude scale of the survey.|||units on a scale||Standard Deviation|Mean
2753198|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:~Instruct patients on home glucose monitoring~Teach foot care~Teach insulin administration~Instruct patients about diet~Help patients make changes in their diets that you have recommended~Instruct patients about regular exercise~Help patients make changes in their exercise habits that you have recommended~Identify candidates for long-acting insulin~Interpret glucose patterns~Adjust insulin in insulin-treated patients with poor glycemic control~Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin~Manage patients with poor glycemic control~Initiate insulin therapy (NPH or insulin glargine and aspart)~Apply principles of diabetes care in a team setting~Averages of provider efficacy were calculated across all activities."|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the ability items of the survey.|||units on a scale||Standard Deviation|Mean
2753199|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:~Instruct patients on home glucose monitoring~Teach foot care~Teach insulin administration~Instruct patients about diet~Help patients make changes in their diets that you have recommended~Instruct patients about regular exercise~Help patients make changes in their exercise habits that you have recommended~Identify candidates for long-acting insulin~Interpret glucose patterns~Adjust insulin in insulin-treated patients with poor glycemic control~Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin~Manage patients with poor glycemic control~Initiate insulin therapy (NPH or insulin glargine and aspart)~Apply principles of diabetes care in a team setting~Averages of provider efficacy were calculated across all activities."|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 55 intervention arm providers completed the ability items of the survey.|||units on a scale||Standard Deviation|Mean
2753200|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 53 intervention arm providers complete the attitude scale of the survey.|||units on a scale||Standard Deviation|Mean
2753201|NCT00854581|Secondary|Overall Survival|Overall survival (OS) is the elapsed time from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up was censored at date of last contact.|From date of treatment initiation until date of death, assessed up to 5 years||||months||95% Confidence Interval|Median
2753202|NCT00854581|Secondary|Failure-free Survival (FFS)|Failure-free survival is the elapsed time from the date of initiation of study treatment until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time was censored at the last documented date of failure-free status.|From date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2753203|NCT00854581|Primary|The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission|Number of participants achieving a molecular remission after starting valproic acid as evidenced by disappearance of T-cell clonality as measured by gene rearrangement studies using multiplex PCR|3, 6 and 12 months.|Participants achieving CR or PR in Part 1 Maintenance and moving on to Part 2B Maintenance therapy|||participants|||Number
2753204|NCT00854581|Primary|Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo|Number of patients exhibiting NF-kb inhibition upon treatment with AZT in vivo. Investigation of whether AZT functions as an inhibitor of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) in vivo by analyzing serially collected leukemic samples during the first 48 hours of treatment with AZT only. The investigators will report the number of participants exhibiting NF-kB inhibition upon treatment with AZT in vivo and correlate with response using two-sample t-test.|During 48 hours of first AZT therapy|Participants receiving Zidovudine (AZT) therapy who achieved complete response (CR) or partial response (PR).|||participants|||Number
2753205|NCT00854581|Primary|Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants|Expressions of c-Rel, IRF-4 or other molecular events (p53, p16 mutations) including expansion of novel clones obtained at time of relapse will be compared to baseline data using paired t-test.|At time of relapse or disease progression, assessed up to 12 months|Study participants were tested for these markers at baseline, but only IRF4 was re-tested at relapse|||participants|||Number
2753322|NCT00853593|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.|||minutes||Standard Deviation|Mean
2753206|NCT00854581|Primary|Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy|"Number of participants achieving complete response (CR) with minimal residual disease at 3, 6 and 12 months post-initiation of protocol therapy. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009.~For imaging, Cheson criteria was used to assess response:~Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) < 4 x 10^9 /L.~Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood.~CR or PR had to persist for a period of at least 4 weeks."|3, 6 and 12 months.|Participants who achieved CR with minimal residual disease in Part 1 Maintenance therapy at Month 3 and moved on the Part 2B maintenance for up to 12 months.|||participants|||Number
2753207|NCT00854581|Primary|Number of Patients Achieving Clinical Response to Protocol Therapy Who Lack IRF-4 and/or c-Rel Expression.|"Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009.~For imaging, Cheson criteria was used to assess response:~Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) < 4 x 10^9 /L.~Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood.~CR or PR had to persist for a period of at least 4 weeks."|Up to 12 months post-initiation of protocol therapy|All participants who had a treatment response (PR or CR)|||participants|||Number
2753208|NCT00854373|Secondary|Pregnancy|Fetal heart motion by transvaginal ultrasound|6 weeks after embryo transfer||||percentage of participants|||Number
2753209|NCT00854373|Secondary|Mature Oocyte Recovery Rate|Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary.|36 hours after hCG trigger||||percentage of follicles|||Number
2753210|NCT00854373|Primary|Mean Fertilization Proportion (2PN/Oocytes Collected)|Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated MII oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).|24 hours after IVF or intracytoplasmic sperm injection (ICSI)|Intention to treat|||percentage of oocytes||Standard Deviation|Mean
2753211|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping).~Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The non-nasal population included only those participants with adequate non-nasal symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 6 or greater for the 24-hour reflective non-nasal symptom score, over the last 7 days of the Run-in Period.|||units on a scale||Standard Error|Least Squares Mean
2753212|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping).~The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The ocular population included only those participants with adequate ocular symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 4 or greater for the 24-hour reflective ocular symptom score, over the last 7 days of the Run-in Period.|||units on a scale||Standard Error|Least Squares Mean
2753213|NCT00854360|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates symptom improvement.|Baseline and Week 2|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
2753214|NCT00854360|Secondary|Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
2753215|NCT00854360|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to the assessment, twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
2753216|NCT00854360|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The Intent-to-treat population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2753217|NCT00854308|Secondary|Duration of Overall Response||Date of initial response until date of progression or death on study. (Up to 20 months)|All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses.||||||
2753218|NCT00854308|Primary|Progression-free Survival in Patients With Met Diagnostic-Positive Tumors|"Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.~PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment)."|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-Positive tumors.|||months||95% Confidence Interval|Median
2753219|NCT00854308|Secondary|Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors|"Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.~Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.~Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-positive tumors.|||Percentage of participants||95% Confidence Interval|Number
2753220|NCT00854308|Secondary|Percentage of Participants With Objective Response|"Objective response (partial and complete response as determined using RECIST 1.0).~Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.~Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients.|||Percentage of participants||95% Confidence Interval|Number
2753221|NCT00854308|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients.|||months||95% Confidence Interval|Number
2753222|NCT00854113|Primary|VZ/F|Pharmacokinetic results. Apparent volume of distribution|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||Liters||Standard Deviation|Mean
2753223|NCT00854113|Primary|CL/F|Pharmacokinetics results. Apparent oral clearance|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||L/hr||Standard Deviation|Mean
2753224|NCT00854113|Primary|Terminal Rate Constant.|Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||L/hr||Standard Deviation|Mean
2753225|NCT00854113|Primary|AUC 0 -24|Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||ng*hr/ml||Standard Deviation|Mean
2753226|NCT00854113|Primary|t1/2|Pharmacokinetics results.t 1/2 - apparent terminal half life|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||hour||Standard Deviation|Mean
2753227|NCT00854113|Primary|AUC 0-t|Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||ng*hr/ml||Standard Deviation|Mean
2753228|NCT00854113|Primary|Tmax|Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||hour||Full Range|Median
2753229|NCT00854113|Primary|Cmax|Pharmacokinetics results. Cmax -Maximum plasma drug concentration|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||ng/ml||Standard Deviation|Mean
2753247|NCT00853957|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2753230|NCT00854100|Secondary|Clinical Global Impression - Improvement (CGI-I)|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.|Week 16|231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.|||Units on a Scale||Standard Error|Least Squares Mean
2753231|NCT00854100|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.|Baseline (Week 8) to Week 16|231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses.|||Units on a Scale||Standard Error|Least Squares Mean
2753232|NCT00854087|Primary|Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|"Efficacy of Fuzheng Huayu treatment was assessed through the change in liver fibrosis stage from the assessment before (pre) and after (post) study drug. The liver fibrosis staging system used was the Ishak scale. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.~Fibrosis improved was defined as a lower post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 3 or lower.~Fibrosis did not change was defined as having the same Ishak score before and after study drug assessments e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 4.~Fibrosis worsened was defined as a higher post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 5 or higher."|Baseline to Week 48|Participants who at least took one dose of study drug (Fuzheng Huayu or Placebo), were more than 80% compliant with study drug and had a pre and post study drug biopsy with an evaluable Ishak fibrosis score. Participants had ALT <300 and a BMI <40.|||participants|||Number
2753233|NCT00854087|Primary|Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.|Baseline to Week 60|||||||
2753234|NCT00853996|Secondary|Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire|"The Health Assessment Questionnaire II (HAQ-II) measures interference in daily activities from arthralgias and joint pain. Range 0 - 4. A higher score indicates greater (i.e., worse) interference."|Baseline to up to 2 weeks post-treatment||||Participants|||Count of Participants
2753235|NCT00853996|Secondary|Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System|Problems with hot flashes were assessed by average number per day and intensity.|Baseline to up to 2 weeks post-treatment||||Participants|||Count of Participants
2753236|NCT00853996|Secondary|Change in Serum Concentration of Testosterone|Change in serum concentration of Testosterone from baseline to 6 months|Baseline to 6 months||||ng/ml||Standard Deviation|Mean
2753237|NCT00853996|Secondary|Change in Serum Concentration of Bioavailable Estradiol|Change in serum concentration of bioavailable estradiol (adjusted for concentration of Sex Hormone Binding Globulin), from baseline to 6 months|Baseline to 6 months||||pM||Standard Deviation|Mean
2753238|NCT00853996|Secondary|Change in Serum Estradiol Concentration|Change in serum concentration of estradiol from baseline to 6 months|Baseline to 6 months||||ng/ml||Standard Deviation|Mean
2753239|NCT00853996|Secondary|Change in Mammographic Breast Density|Change in mammographic density from baseline to 6 months, The Percent Breast Density is estimated using the Cumulus computer-assisted program to define a region that is at greater density than the remainder of the breast.|Baseline to 6 months|One subject was without a digital file due to technical reasons. Thus, only 24 subjects were evaluated.|||percentage of area at increased density||Inter-Quartile Range|Median
2753240|NCT00853996|Primary|Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months|Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.|Baseline to 6 months||||percentage of positive cells||Inter-Quartile Range|Median
2753241|NCT00853970|Secondary|Pain Free|Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.|Day 1|Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population|||participants|||Number
2753242|NCT00853970|Primary|Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15 (Primary Endpoint)|Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population|||participants|||Number
2753243|NCT00853957|Secondary|Percentage of Patients With Peripheral Edema by Visit|Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.|8 weeks|Full Analysis Set|||Percentage of participants|||Number
2753244|NCT00853957|Secondary|Change From Baseline in MSSBP at Week 1 and 4|Compare the change from baseline in MSSBP at week 1 and 4|Baseline, 1 and 4 weeks|Full analysis set, Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2753248|NCT00853957|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2753249|NCT00853905|Secondary|Ocular Hypotensive Medications|Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.|1 week, 1 month, 3 month, and or 6 month post-op visits||||eye drops||95% Confidence Interval|Mean
2753250|NCT00853905|Secondary|Patient Comfort|Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.|1 day, 1 week, 1 month, 3 month and 6 month post-op visits||||Patient comfort questionnaire score||95% Confidence Interval|Mean
2753251|NCT00853905|Secondary|Bleb Appearance|A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.|1 day, 1 week, 1 month, 3 month and 6 month post-op visits|Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured.|||units on a scale||95% Confidence Interval|Mean
2753252|NCT00853905|Secondary|Anterior Chamber Inflammation (Flare)|Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).|1 month, 3 month and 6 month post-op visits||||photon counts per millisecond (p/msec)||95% Confidence Interval|Mean
2753253|NCT00853905|Primary|Intraocular Pressure (IOP)|Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.|1 day, 1week, 1 month, 3 month and 6 month post-op visits||||mm Hg||95% Confidence Interval|Mean
2753254|NCT00853840|Secondary|Number of Subjects With Postural Hypotension|Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose.|Period 1 and Period 2 (up to 8 days)|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||participants|||Number
2753255|NCT00853840|Secondary|Postural Changes in Pulse Rate|Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||beats per minute (bpm)||Standard Deviation|Mean
2753256|NCT00853840|Secondary|Postural Changes in Systolic and Diastolic Blood Pressure|Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||mm Hg||Standard Deviation|Mean
2753257|NCT00853840|Secondary|Standing and Supine Pulse Rate|Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2753258|NCT00853840|Primary|Standing and Supine Systolic and Diastolic Blood Pressure (BP)|Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||mm Hg||Standard Error|Least Squares Mean
2753259|NCT00853827|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.|104 weeks|Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received|||Number of patients|||Number
2753260|NCT00853827|Secondary|Patients That Demonstrated Evidence of Atheroma Regression|Atheroma regression is defined as change from baseline to endpoint in PAV <0 .|Baseline to endpoint (104 weeks)|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization|||Participants|||Number
2753323|NCT00853593|Secondary|Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead|A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.|During implant procedure.|Subjects who underwent an implant attempt.|||participants|||Number
2753261|NCT00853827|Secondary|Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS|Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.|||mm^3||Standard Error|Least Squares Mean
2753262|NCT00853827|Primary|Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment|Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.|||percentage of baseline||Standard Error|Least Squares Mean
2753263|NCT00853762|Primary|Number of Subjects With Positive Neutralizing Antibody (NAb)||Baseline, Week 12 and 36|Appropriate method/test was not established to identify the positive neutralizing antibodies for atacicept. Hence, this outcome measure was not assessed.||||||
2753264|NCT00853762|Secondary|Pharmacogenetics/Pharmacogenomics Analysis|"Gene expression profiling and gene polymorphism identification were to be used to identify putative markers for response to treatment.~Genome-wide gene polymorphism characterization by genome-wide scan.~Targeted gene polymorphism identification of B-Lymphocyte Stimulator (BLyS) , APRIL, (receptor for B cell activating factor of the tumor necrosis factor [TNF] family) BAFF-R, (Transmembrane Activator) TACI and (B Cell Maturation Antigen) BCMA and HLA-DRB1 by direct genotyping or sequencing ."|Day 1 and Week 36|Genetic/genomic analysis was not performed as the trial was terminated early.||||||
2753265|NCT00853762|Secondary|Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.|Levels of free APRIL and free BLyS: Free APRIL serum samples were to be analyzed by using a validated enzyme-linked immunosorbent assay (ELISA) with limits of detection of 0.3125 nanogram per milliliter (ng/mL) for free APRIL and free BlyS serum samples were analysed using a validated ELISA with limits of detection of 1.56 ng/mL.|Baseline, Week 12 and 36|This outcome measure was not assessed due to lack of a valid assay for measuring BLyS and APRIL.||||||
2753266|NCT00853762|Secondary|Concentrations of Free and Total Atacicept||Baseline and Week 12|This outcome measure was not assessed due to lack of a valid assay during the usable time period of the samples.||||||
2753267|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject||Baseline, Week 12 and Week 24||||Cubic millimeter||Standard Deviation|Mean
2753268|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject||Baseline, Week 12 and 24|Intent-to-treat (ITT) population included all randomized subjects. “n” signifies the number of evaluable subjects for this outcome measure.|||Number of lesions per subject||Standard Deviation|Mean
2753269|NCT00853762|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies number of evaluable subjects for this outcome measure."|||z-score||Standard Deviation|Mean
2753270|NCT00853762|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies (total number of subjects analyzed) the number of evaluable subjects for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2753271|NCT00853762|Secondary|Number of Subjects With Clinical Attacks/Relapses|"A clinical attack/relapse was defined as the fulfillment of all the following criteria:~Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours.~Absence of fever or known infection (fever with temperature (axillary, orally, or intra-auriculary) > 37.5°C/99.5 °Fahrenheit).~Objective neurological impairment, correlating with the subject's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated."|Baseline up to Week 24|Intent-to-treat (ITT) population included all randomized subjects.|||Subjects|||Number
2753283|NCT00853749|Primary|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination|Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
2753272|NCT00853762|Primary|Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels|Number of subjects with shifts from normal Grade (Grade 0) at Baseline to worse value at post-baseline (Grade 1 to Grade 4) according to the following criteria: IgA Grade 0: greater than or equal to (>=) lower limit normal (LLN) 0.7 gram per liter (g/L); Grade 1: less than (<) LLN - 0.5 g/L, Grade 2: <0.5g/L -0.3 g/L, Grade 3: <0.3 g/L -0.1 g/L, Grade 4: < 0.1 g/L; IgG Grade 0: >= LLN (7 g/L), Grade 1: < LLN - 5 g/L, Grade 2: <5g/L -4 g/L, Grade 3: <4 g/L -3 g/L and Grade 4: < 3 g/L; IgM Grade 0: >= LLN (0.4 g/L), Grade 1: < LLN - 0.3 g/L, Grade 2: <0.3 g/L -0.2 g/L, Grade 3: <0.2 g/L -0.1 g/L, and Grade 4: < 0.1 g/L are presented in this outcome measure.|Baseline up to Week 36|Intent-to-treat (ITT) population included all randomized subjects.|||Subjects|||Number
2753273|NCT00853762|Primary|Change From Baseline in Electrocardiogram (ECGs)||Baseline, Week 12 and 36|No summary tables were prepared for ECG parameters, and ECG data were not formally analyzed. However, a qualitative assessment of ECG morphology and rhythm was made by the Investigator and recorded in the electronic case report form (eCRF). ECG abnormalities considered significant by the investigator were reported as AEs.||||||
2753274|NCT00853762|Primary|Change From Baseline in Vital Signs: Temperature||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.|||Degree Celsius||Standard Deviation|Mean
2753275|NCT00853762|Primary|Change From Baseline in Vital Signs: Pulse Rate||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.|||beats per minute (beats/min)||Standard Deviation|Mean
2753276|NCT00853762|Primary|Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure (systolic and diastolic) was measured after at least 3 minutes resting, with the subject in the seated position.|Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2753277|NCT00853762|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity|"TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was graded as per Qualitative Toxicity Scale. Local injection site reactions (injection site: pain, redness, itching and swelling) throughout ATAMS Extension, starting after the first trial medication administration. If the subject experienced 1 or more of the above injection site symptoms, these were reported with the AE verbatim term injection site reaction. For all randomized subjects, there was an option of rescue treatment with Rebif® for 1 year beginning with the first injection of Rebif®)."|From the first dose of study drug administration up to Week 24|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study.|||Subjects|||Number
2753278|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination|Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 4|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic|||Percentage of participants|||Number
2753279|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Particpants may have been represented in more than 1 category.|Day 1 through Day 4|Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic|||Percentage of participants|||Number
2753280|NCT00853749|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all particpants with available data for the specified blood draw.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2753281|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (OPA)|Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype.|||GMT||95% Confidence Interval|Geometric Mean
2753282|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (Avidity Assay)|Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).|Day 28|Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype.|||AI||95% Confidence Interval|Geometric Mean
2753284|NCT00853749|Primary|Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination|Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
2753285|NCT00853723|Secondary|Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)|"Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP < or = 0.86 then TMP/GFR = TRP x P phos if TRP > 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos~U= urine, P = plasma"|Baseline, Day 15, Day 30, Day 60, Day 90||||mg/dl||Standard Error|Mean
2753286|NCT00853723|Secondary|Fractional Excretion of Calcium|(Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)|Baseline, Day 15, Day 30, Day 60, Day 90||||% excreted||Standard Error|Mean
2753287|NCT00853723|Secondary|1,25 Vitamin D||Baseline, Day 15, Day 30, Day 60, Day 90||||pg/ml||Standard Error|Mean
2753288|NCT00853723|Secondary|24 Hour Urine Calcium||90 days||||mg/gm creatinine||Standard Error|Mean
2753289|NCT00853723|Secondary|Serum Phosphorous||Baseline, Day 15, Day 30, Day 60, Day 90||||mg/dl||Standard Error|Mean
2753290|NCT00853723|Secondary|Total Serum Calcium (mg/dl)||Baseline, Day 15, Day 30, Day 60, Day 90||||mg/dl||Standard Error|Mean
2753291|NCT00853723|Secondary|Changes in Bone Mineral Density of the Distal 1/3 Radius.||90 days||||Percent change from baseline||Standard Error|Mean
2753292|NCT00853723|Secondary|Changes in Bone Mineral Density of the Forearm.||90 days||||Percent change from baseline||Standard Error|Mean
2753293|NCT00853723|Secondary|Changes in Bone Mineral Density of the Femoral Neck.||90 days||||Percent change from baseline||Standard Error|Mean
2753294|NCT00853723|Secondary|Changes in Bone Mineral Density of the Total Hip.||90 days||||Percent change from baseline||Standard Error|Mean
2753295|NCT00853723|Primary|Carboxy-terminal Telopeptides of Collagen-1 (CTX)||Baseline, Day 15, Day 30, Day 60, Day 90||||percentage change from baseline||Standard Error|Mean
2753296|NCT00853723|Secondary|Changes in Bone Mineral Density of the Lumbar Spine.||90 days||||Percent change from baseline||Standard Error|Mean
2753297|NCT00853723|Primary|Procallagen-1 Amino-terminal Peptide (P1NP)||Baseline, Day 15, Day 30, Day 60, Day 90||||percentage change from baseline||Standard Error|Mean
2753298|NCT00853671|Secondary|Per-Patient Correlation Between CTP and SPECT at Rest.|Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.|18 months||||correlation coefficient|||Number
2753299|NCT00853671|Primary|Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.|The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.|18 months||||percentage of participants||95% Confidence Interval|Number
2753300|NCT00853671|Secondary|Per-Patient Correlation Between CTP and SPECT at Stress.|Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.|18 months||||correlation coefficient|||Number
2753301|NCT00853671|Primary|Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.|The gold standard for abnormality by CTP is defined as a focal stenosis of >50% at quantitative analysis of invasive coronary angiography images, when performed.|18 months||||percentage of participants||95% Confidence Interval|Number
2753302|NCT00853658|Secondary|All Cause Death|Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.|up to end of study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations|||participants|||Number
2753303|NCT00853658|Secondary|Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 12|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.|||KCCQ Score||Standard Error|Least Squares Mean
2753304|NCT00853658|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to End of Study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.|||participants|||Number
2753305|NCT00853606|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.|Baseline, End of Treatment|Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Deviation|Mean
2753306|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents to Intent-to-Treat population.|||percentage of sexual attempts||Standard Deviation|Mean
2753307|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Deviation|Mean
2753308|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing|Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.|6 month|Subjects with bipolar configuration electrode R-wave amplitude at 6 month.|||mV||Standard Deviation|Mean
2753309|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance|Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with bipolar configuration pacing impedance at 6 month|||Ohms||Standard Deviation|Mean
2753310|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold|Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.|6 month|Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month|||Volts||Standard Deviation|Mean
2753311|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing|Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.|During implant procedure.|Subjects with ring electrode R-wave amplitude at implant|||mV||Standard Deviation|Mean
2753312|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance|Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with ring electrode pacing impedance at 6 month|||Ohms||Standard Deviation|Mean
2753313|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold|Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.|6 month|Subjects with ring electrode threshold captured at 0.5 ms at 6 month|||Volts||Standard Deviation|Mean
2753314|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing|Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.|6 month|Subjects with tip electrode R-wave amplitude at 6 month|||mV||Standard Deviation|Mean
2753315|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance|Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with tip electrode pacing impedance at 6 month|||Ohms||Standard Deviation|Mean
2753316|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold|Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.|6 month|Subjects with tip electrode threshold captured at 0.5 ms at 6 month|||Volts||Standard Deviation|Mean
2753317|NCT00853593|Secondary|Efficacy: Bipolar Voltage Threshold|Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts.|1 month|Subjects that were implanted with a Model 4396 lead and completed the 1 month visit|||Volts||Standard Deviation|Mean
2753318|NCT00853593|Secondary|Assessment of Lead Handling Characteristics Reported as Acceptable|Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.|During implant procedure.|Subjects who underwent a Model 4396 left ventricular lead implant attempt.|||participants|||Number
2753319|NCT00853593|Secondary|Total Operation Time|Total operation time was defined as time from initial incision to final closure.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.|||minutes||Standard Deviation|Mean
2753320|NCT00853593|Secondary|Model 4396 Lead Placement Time|Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported.|||minutes||Standard Deviation|Mean
2753324|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead|A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.|During implant procedure.|Subjects who underwent an implant attempt.|||participants|||Number
2753325|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation|A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.|During implant procedure.|Subjects with successful CS cannulation after an implant attempt.|||participants|||Number
2753326|NCT00853593|Secondary|Subjects Successfully Implanted With Model 4396 Lead|A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.|During implant procedure.|Subjects who underwent Model 4396 LV implant attempt.|||participants|||Number
2753327|NCT00853593|Primary|Efficacy: Proximal Ring Voltage Threshold|Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.|Three months|Subjects with ring electrode threshold captured at 0.5 ms at 3-month|||Volts||Standard Deviation|Mean
2753328|NCT00853593|Primary|Efficacy: Distal Tip Electrode Voltage Threshold|Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds [ms]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.|One month|Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.|||Volts||Standard Deviation|Mean
2753329|NCT00853593|Primary|Safety (Subjects Without a Model 4396 Lead Related Complication)|A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).|One month|Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.|||participants|||Number
2753330|NCT00853580|Secondary|Psychosocial Quality of Life PedsQL|Self-rated questionnaire of psychosocial Quality of Life (including emotional, social and school functioning). Summary scores are reported. Higher scores indicate higher quality of life (range 0-100).|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
2753331|NCT00853580|Secondary|Quality of Life Pediatric Quality of Life Inventory (PedsQL)|Parent-rated questionnaire of psychosocial Quality of Life (including emotional, social and school functioning). Summary scores are reported. Higher scores indicate increased increased quality of life (range 0-100).|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
2753332|NCT00853580|Secondary|Internalizing Behaviors, Behavior Assessment System for Children Second Edition|A self-reported questionnaire assessing internalizing behaviors such as anxiety and depression. T-scores are reported. Higher scores indicate increased internalizing behaviors. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753333|NCT00853580|Secondary|Internalizing Behaviors, Behavior Assessment System for Children Second Edition|A parent-reported questionnaire assessing internalizing behaviors of anxiety, depression and somatization. T-scores are reported. Higher scores indicate increased internalizing behaviors. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753334|NCT00853580|Secondary|Object Assembly (WISC-III)|A measure of visuoperceptual organization. Participants were required to rebuild an item puzzle based on disassembled pieces. Age scaled scores are reported, which have a population mean of 10 and standard deviation of 3 (range 1-19). Higher scores indicate better performances.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
2753335|NCT00853580|Secondary|Behavior Rating Inventory of Executive Function Global Executive Composite|A parent-rated questionnaire of executive behaviour assessing behavioral regulation (inhibit, shift, emotional control) and metacognition (initiate, working memory, plan/organize, organization of materials, self-monitoring). T-scores for the Global Executive Composite (overall summary score) are reported. Higher scores indicate poorer executive behaviors.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753379|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2753336|NCT00853580|Secondary|Judgement of Line Orientation Test|A test of visuospatial judgement. The test measured the participant's ability to match the angle and orientation of lines in space. There were 30 trial in total. Correct response in a trial was awarded one point (range 0-30). Higher scores represent better performances. Raw data are reported.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Total correct responses||Standard Deviation|Mean
2753337|NCT00853580|Secondary|Controlled Oral Word Association Test|A measure of verbal fluency. Participants were required to spontaneously produce as many words as they could, beginning with a designated letter in 60 seconds. Three letters were used. Higher scores represent better performances. Raw data are reported summing total words generated for all three letters. Scale does not have a maximum range.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Total words||Standard Deviation|Mean
2753338|NCT00853580|Secondary|ADHD Hyperactive/Impulsive Scale, Conners ADHD Scales|Parent rated hyperactive/impulsive ADHD symptoms, based on Diagnostic and Statistical Manual of Mental Disorders criteria, 4th edition.T-scores are reported. Higher scores indicate increased ADHD-related symptoms. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753339|NCT00853580|Secondary|ADHD Inattentive Scale, Conners ADHD Scales|Parent rated inattentive ADHD symptoms, based on Diagnostic and Statistical Manual of Mental Disorders criteria, 4th edition. T-scores are reported. Higher scores indicate increased ADHD-related symptoms. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753340|NCT00853580|Secondary|Omission Errors (Conners Continuous Performance Test, Second Edition; CPT-II)|A computerised measure of vigilance and concentration. Letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Omission errors represented the number of times a participant fails to respond to target letters (all other than 'X'). T-scores are reported, as generated by the test software. Higher scores indicate poorer performances.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753341|NCT00853580|Secondary|Commission Errors (Conners Continuous Performance Test, Second Edition; CPT-II)|A computerised measure of impulse control. Letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Commission errors represented the number of times a participant incorrectly responded to the non-target (letter 'X'). T-scores are reported, as generated by the test software. Higher scores indicate poorer performances.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
2753342|NCT00853580|Secondary|Creature Counting (Test of Everyday Attention for Children)|"Creature Counting is a measure of attentional control. Participants were required to count creatures from top of the page to the bottom, using arrows as cues to switch from counting up to counting down (and vice versa). There were seven testing trials. The outcome variable was the total number of correct trials (range 0-7). Higher scores represent better performances."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
2753343|NCT00853580|Secondary|Sky Search DT (Test of Everyday Attention for Children)|Sky Search DT is a test of divided attention. Children completed a parallel version of the Sky Search subtest while at the same time, silently counted the number of tones in a similar way to the Score! subtest. Higher scores represent poorer performance. Raw data are reported. Scale does not have a maximum range.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
2753344|NCT00853580|Secondary|Sky Search (Test of Everyday Attention for Children)|Sky Search is a measure of selective visual attention. Participants were presented with a A3 sheet with target stimuli (spaceships in identical pairs) randomly distributed among many distractors (spaceships in non-identical pairs). They were required to circle as many of the targets as possible as quickly as possible. The outcome measure (attention score), was a timing score reflecting the average time taken per target found. Higher scores represent poorer performance. Raw data are reported. Scale does not have a maximum range.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
2753345|NCT00853580|Secondary|Stop Signal Task (Cambridge Neuropsychological Test Automated Battery)|"A computerized measure of inhibitory control. The participant quickly responded to an arrow stimulus by pressing one of two buttons (left or right), depending on the direction in which the arrow pointed on the screen. If an audio tone is present, the subject was supposed to withhold the response.~The difficulty of the task was manipulated by altering the delay before a stop signal (auditory tone) was presented, known as the stop signal delay. The outcome from this measure was stop signal reaction time (last half of test), which was computed by subtracting the mean stop signal delay at which the participant was able to stop on 50% of trials from the mean reaction time on go trials. Poorer response inhibition was reflected by a larger stop signal reaction time. Scale does not have a maximum range."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Milliseconds||Standard Deviation|Mean
2753346|NCT00853580|Secondary|Stockings of Cambridge (Cambridge Neuropsychological Test Automated Battery) Automated Battery).|"A computerized measure of spatial planning based on the Tower of London test. It required participants to move balls in a lower display to match a pattern shown in the upper display in a certain number of moves.~More specifically, the participant was shown two displays containing three coloured balls. The displays were presented in such a way that they could be perceived as stacks of coloured balls held in socks suspended from a beam. The test administrator first demonstrated to the participant how to move the balls in the lower display to copy the pattern in the upper display and completed one demonstration problem, where the solution required one move. The participant then completed problems that increased in difficulty, from one through to five move problems.~The unit of measure was the mean number of moves taken to complete a problem that could not be completed in less than five moves. The higher the score, the poorer the performance (range 5-12)."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Moves||Standard Deviation|Mean
2753347|NCT00853580|Secondary|Spatial Working Memory (Cambridge Neuropsychological Test Automated Battery)|"A computerized measure of spatial working memory. This task assessed the participant's ability to retain spatial information and to manipulate remembered items in working memory.~In this test, participants were shown an array of boxes on a computer screen and they were required to search through the boxes for hidden tokens. One box at a time was touched until a blue token was found inside. Participants then commenced a new search for the next token. The key instruction was that, once a token had been located, that box would not be used again to hide another token.~Unit of measure was between search errors, determined by the number of boxes a participant reopens in which a token had previously been found. Higher score indicated poorer performance. Scale does not have a maximum range."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Errors||Standard Deviation|Mean
2753348|NCT00853580|Primary|Score! (Test of Everyday Attention for Children)|Score! is a measure of sustained attention. Participants were required to silently count a series of aurally presented tones and say the total number of tones counted at the end of each trial. The number of tones ranged from 9 to 15, with a total of 10 trials (range 0-10). Higher values represent better performance.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Units on a scale||Standard Deviation|Mean
2753349|NCT00853580|Primary|Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery).|A computerized test of visuospatial learning. Participants had to remember patterns associated with different locations on the screen, and during the test phase, as each pattern is presented, point to the appropriate location. The test starts at a very simple level and gradually increases in difficulty. Higher number of errors indicates poorer performance. Scale does not have a maximum range.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||PAL Total Errors||Standard Error|Mean
2753350|NCT00853567|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated||||||
2753351|NCT00853489|Secondary|Medical Cost|An economic evaluation will also be performed including the costs of iliac crest bone graft harvest and complications from the bone graft surgery and the cost of the Rh-BMP 2 and the biologic implant used in the treatment group.|12 mos post op|Hospital bills for bone graft surgery admission were available on 25 patients total|||dollars for total admission cost||Full Range|Mean
2753352|NCT00853489|Secondary|Infection|Infection will be assessed based on the CDC criteria for deep and superficial infection.|12 months post op.|Infection was decribed in protocol|||Participants|||Count of Participants
2753353|NCT00853489|Primary|Fracture Healing (Union) at 12 Months|"Union will be defined by:~1. Radiographic union as defined by the Radiographic union scale in tibia fractures (RUST) score, Radiographic evaluation will be assessed by blinded orthopaedic surgeons."|12 months post op|RUST scores were used to determine radiograpghic union at 52 weeks|||Participants|||Count of Participants
2753354|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2754297|NCT00847509|Primary|[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan|The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.|3-5 weeks after the start of radiation or chemo radio therapy|||||||
2753355|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753356|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
2753357|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
2753358|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||days||Standard Deviation|Mean
2753359|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||days||Standard Deviation|Mean
2753360|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||events||Standard Deviation|Mean
2753361|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||events||Standard Deviation|Mean
2753362|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753363|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753364|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753365|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753366|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2753367|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753368|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.|||participants|||Number
2753369|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||participants|||Number
2753370|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753380|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2753371|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753372|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2753373|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753374|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753375|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753376|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2753377|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2753378|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2753381|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2753382|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753383|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753384|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.||||||
2753385|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.||||||
2753386|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753387|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753388|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753389|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753390|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
2753391|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
2753392|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
2753393|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
2753394|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
2753395|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
2753396|NCT00853385|Primary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).|||percentage of participants|||Number
2753397|NCT00853385|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2753398|NCT00853385|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.|||percentage of participants|||Number
2753399|NCT00853333|Primary|Pain Rating Change|"Mechanical Slide Algometer (www.decisionaidsonline.com), Range: No Pain Sensation (1) to  Most Intense Sensation Imaginable (10) 10 point scale.~Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention."|Sedation||||units on a scale||Standard Error|Least Squares Mean
2753400|NCT00853307|Secondary|Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events|Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months|Safety Population is defined as all participants who received any amount of alisertib.|||participants|||Number
2753401|NCT00853307|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events|Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. . A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months)|Safety Population is defined as all participants who received any amount of alisertib.|||participants|||Number
2753402|NCT00853307|Secondary|Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose to 30 days past last dose (Up to 18.9 Months)|Safety Population is defined as all participants who received any amount of alisertib.|||participants|||Number
2753403|NCT00853307|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and receive at least 1 dose of alisertib and have at least 1 post-baseline response assessment|||percentage of participants|||Number
2753404|NCT00853307|Secondary|Time To Progression (TTP)|TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Due to study termination, there was insufficient data to perform this analysis.||||||
2753405|NCT00853307|Secondary|Duration Of Response (DOR)|DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Due to study termination, there was insufficient data to perform this analysis.||||||
2753406|NCT00853307|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response assessment that is stable disease (SD) or better.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Response-evaluable population is defined as all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.|||days||95% Confidence Interval|Median
2753407|NCT00853307|Primary|Combined Best Overall Response Rate Based on Investigator Assessment|Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).|Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/milliliter (mL) and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.|||percentage of participants|||Number
2753411|NCT00853242|Secondary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)||Baseline, Day 22|FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure <= 3 days after date of last study drug.|||mg/dL||Standard Deviation|Mean
2753412|NCT00853242|Primary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)||Baseline, Day 22|Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (<=) 3 days after date of last study drug.|||mg/dL||Standard Deviation|Mean
2753413|NCT00853229|Secondary|Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)|Data not measured due to early discontinuation of the study prior to the designated follow up time frame.|4 weeks|||||||
2753414|NCT00853229|Primary|Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)|Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.|4 weeks|||||||
2753415|NCT00853151|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) at 3-Week and 6-Month Endpoints|Values from repeated measures include fixed categorical effects of treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate of baseline HOMA derived beta-cell function (HOMA-B). HOMA=index of function of cells that make insulin. Indices derived from fasting glucose and insulin concentrations. HOMA is measurement reflecting fasting plasma glucose and insulin. Has no defined minimum/maximum value. HOMA-B values generated from table reflecting values derived from Oxford HOMA2 model calculator. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline HOMA value.|||units on a scale||Standard Error|Least Squares Mean
2753416|NCT00853151|Secondary|Change From Baseline in Fasting Insulin at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline Fasting Insulin. Fasting insulin is the Mixed-Meal Tolerance Test (MMTT) insulin assessment at timepoint 0, where available, otherwise it is the assessment taken from the fasting laboratory measurements obtained during the clinic visit. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline fasting insulin value.|||microinternational units/milliliter||Standard Error|Least Squares Mean
2753417|NCT00853151|Secondary|Number of Participants With Adjudicated and Confirmed Deaths and Non-Fatal Cardiovascular (CV) Events at Any Timepoint|The protocol specified that deaths and nonfatal cardiovascular (CV) adverse events (AEs) be adjudicated by independent physician(s) with cardiology or neurology experience. The CV AEs to be adjudicated were protocol-defined as myocardial infarction (MI), hospitalization for unstable angina or for heart failure, coronary interventions (coronary artery bypass graft or percutaneous coronary intervention [PCI]) and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack (TIA). 3 CV events were adjudicated by an external independent adjudication committee.|Baseline (Week -1) through 6 months|All participants who received at least 1 dose of TT223 or its placebo.|||participants|||Number
2753418|NCT00853151|Secondary|Number of Participants With Hypoglycemia|The number of participants for whom low blood glucose was reported. Hypoglycemia ≥1 events including: severe hypoglycemia(glucose <50mg/dL, unable to treat self or recover after treatment); documented symptomatic (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms); asymptomatic (glucose ≤70mg/dL no symptoms); probable symptomatic (glucose missing, adrenergic or neuroglycopenic symptoms); relative (glucose >70mg/dL, adrenergic or neuroglycopenic symptoms), nocturnal (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms between bedtime/waking).|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||participants|||Number
2753419|NCT00853151|Secondary|Percentage of Participants With Hypoglycemia|Calculation of frequency of low glucose for time period. Hypoglycemia≥1 events: severe<50mg/dL, unable to treat self/recover after treatment; documented symptomatic≤70mg/dL, adrenergic/neuroglycopenic symptoms; asymptomatic≤70mg/dL no symptoms; probable symptomatic glucose missing, adrenergic/neuroglycopenic symptoms; relative>70mg/dL, adrenergic/neuroglycopenic symptoms, nocturnal≤70mg/dL, adrenergic/neuroglycopenic symptoms between bedtime/waking. Because number participants who experienced hypoglycemia was low for every arm (1-3/arm) did not model percentage participants with hypoglycemia.|Baseline (Week -1) through 6 months|Because the number of hypoglycemia events were too low to model the percentage of hypoglycemia, zero participants were analyzed.|||percentage of participants|||Number
2753420|NCT00853151|Secondary|Percentage of Participants With 2-Fold Elevation of Lipase and/or Amylase at Any Timepoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline amylase.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
2753421|NCT00853151|Secondary|Change From Baseline in Amylase at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline amylase value.|||units/liter (U/L)||Standard Error|Least Squares Mean
2753422|NCT00853151|Secondary|Change From Baseline in Lipase at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline serum lipase. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||units per liter (U/L)||Standard Error|Least Squares Mean
2753423|NCT00853151|Secondary|Change From Baseline in 7-Point Profile, Self-Monitored Blood Glucose (SMBG) at 4-Week and 6-Month Endpoints|7-point average=average of mean value of all time points for visit (premorning meal, 2-hours postmorning meal, premidday meal, 2-hours postmidday meal, preevening meal, 2-hours postevening meal, bedtime). Values represent mean of values collected same time on 3 separate days within week prior to visit. Values from repeated measures included fixed categorical effects: treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate baseline <7-point average glucose value or time point presented. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value for the variable being analyzed.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2753424|NCT00853151|Secondary|7-point Profile, Self-Monitored Blood Glucose (SMBG) Values|The 7-point average is the average of the mean value of all time points for the visit. Time points included pre-morning meal, 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and bedtime.|Baseline (Week -1), 4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2753425|NCT00853151|Secondary|Change From Baseline in Waist Circumference at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||centimeters (cm)||Standard Deviation|Mean
2753426|NCT00853151|Secondary|Visual Analog Scale (VAS) for Nausea|The Visual Analog Scale (VAS) is a continuous measure for degree of nausea and/or gastrointestinal discomfort. Each of these scales is 100 millimeters (mm) in length with 0 meaning no nausea at all and 100 meaning extreme nausea. Participants record self-assessment of how much nausea they have had, from 0 to 100, during the time interval indicated.|4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.|||units on a scale||Standard Deviation|Mean
2753427|NCT00853151|Secondary|Pharmacokinetics (PKs) of LY2428757, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug. LY2428757 concentrations were collected at only a single timepoint; therefore, pharmacokinetic (PK) parameters could not be modeled from the data. Analysis was not done due to insufficient time points being collected.|0 (pre-dose)|Analyses were not conducted due to insufficient time points being collected; zero participants were analyzed.|||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2753428|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|Apparent volume of distribution during the terminal phase after extra-vascular administration (Vz/F) is the apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-state after extra-vascular administration (Vss/F) is the apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2753429|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2753430|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Area Under Concentration Versus Time From Zero to Infinity (AUC[0-infinity])|Area under concentration versus time curve from zero to infinity (AUC[0-infinity]). Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
2753431|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Half Life (t1/2)|Half-life (t1/2) is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Geometric Coefficient of Variation|Geometric Mean
2753432|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Full Range|Geometric Mean
2753433|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2753502|NCT00853021|Other Pre-specified|CD303+ Plasmacytoid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
2753434|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|volume of distribution during the terminal phase after extra-vascular administration (Vz/F): Apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-State after extra-vascular administration (Vss/F): Apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2753435|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-Vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2753436|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Area Under the Curve (AUC)(0-infinity)|Area under the curve (AUC)(0-infinity) = area under concentration versus time from zero to infinity. Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
2753437|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Half-Life (t1/2) Associated With the Terminal Rate Constant (λz) in Non-Compartmental Analysis|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Geometric Coefficient of Variation|Geometric Mean
2753438|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2753439|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Full Range|Geometric Mean
2753440|NCT00853151|Secondary|Number of Participants With Antibodies to TT223|Participants who were positive for antibodies for TT223.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||participants|||Number
2753441|NCT00853151|Secondary|Number of Participants With Antibodies to LY2428757|Participants who were positive for antibodies to LY2428757.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||participants|||Number
2753442|NCT00853151|Secondary|Mean Change From Baseline in Weight at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline weight. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline weight value.|||kilograms (kg)||Standard Error|Least Squares Mean
2753443|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Adjusted for Baseline HbA1c, C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance, Duration of Diabetes, and Weight at 3-Week, 4-Week, 2-Month, 3.5-Month, 5-Month, and 6-Month Endpoints|The subgroup analyses for fasting blood glucose (FBG) (adjusted for baseline glycosylated hemoglobin [HbA1c]), C-peptide level, homeostasis model assessment of insulin resistance (HOMA), duration of diabetes, and weight) were not performed due to the lack of statistically significant findings in the subgroup analysis for the glycosylated hemoglobin (HbA1c) analyses. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 4 weeks, 2 months, 3.5 months, 5 months, 6 months||||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2753444|NCT00853151|Secondary|Change From Baseline in MMTT Response (Postprandial Glucose, Glucose AUC, Insulin/c-Peptide Secretory Response, HOMA, GLP-1, Glucagon) Adjusted for Baseline HbA1c, C-Peptide Level, HOMA, Duration of Diabetes, Weight at Week 0, 3, Month 3.5, 6 Endpoints|Subgroup analyses for mixed meal tolerance test (MMTT) response (adjusted for baseline glycosylated hemoglobin (HbA1c), C-peptide level, Homeostasis Model Assessment of Insulin Resistance (HOMA), duration of diabetes, weight) not performed due to lack of statistically significant findings in subgroup analysis for HbA1c analyses. HOMA was not done for mixed meal tolerance test (MMTT) because it is not calculated from the mixed meal tolerance test (MMTT). It is reported separately as a secondary outcome measure. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 3 weeks, 3.5 months, 6 months|Because the subgroup analyses for MMTT response were not conducted due to the lack of statistically significant findings in the subgroup analysis for the HbA1c analyses, zero participants were analyzed.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2753503|NCT00853021|Other Pre-specified|Peripheral Blood CD1c+ Myeloid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), Beginning and end of cycle 1 (day 1, 57)|||||||
2753445|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) Adjusted for Baseline Glycosylated Hemoglobin (HbA1c), C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance (HOMA), Duration of Diabetes, and Body Mass Index (BMI) at 6-Month Endpoint|HbA1c adjusted: baseline HbA1c (<8%,≥8%); C-peptide level (normal, elevated); HOMA (<baseline median,≥baseline median); duration diabetes (<3,3-10,>10 years); BMI (<30,≥30). BMI estimates body fat based on weight/height squared. HOMA: index of function of cells that make insulin/insulin resistance. Indices derived from fasting glucose and insulin concentrations. LS means adjusted for treatment, baseline therapy, visit, treatment-by-visit, subgroup, subgroup-by-treatment, subgroup-by-visit, subgroup-by-treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline value.|||percent glucosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
2753446|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline fasting blood glucose (FBG). Fasting blood glucose (FBG) is the mixed meal tolerance test (MMTT) glucose assessment at time point 0, where available, otherwise it is the assessment taken from the chemistry panel. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline fasting blood glucose (FBG) value.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2753447|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Post-Prandial Glucose at 3-Week and 6-Month Endpoints|Standardized MMTT to assess changes in function of cells that make insulin (pancreatic beta cells). Glucose measured at 2-hour timepoint during MMTT reflects glucose values in response to meal. Change in postprandial glucose calculated based on difference of 2-hour postprandial glucose at endpoint compared to baseline. Larger changes from baseline represent a greater postprandial glucose compared to 2-hour timepoint prior to treatment. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit and time point being assessed.|||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
2753448|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon-like Peptide-1 (GLP-1) Area Under the Cure (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under plasma glucagon-like peptide-1 (GLP-1) concentration versus time curve calculated using linear-trapezoidal method. Area under the curve (AUC) for glucagon-like peptide-1 (GLP-1) represents the AUC of GLP-1 values when plotted over time. Larger AUC values represent a greater average GLP-1 value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.|||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
2753449|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under the plasma glucagon concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucagon represents the AUC of glucagon values when are plotted over time. Larger area under the curve (AUC) values represent a greater average glucagon value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.|||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
2753450|NCT00853151|Secondary|Change From Baseline in Mixed Meal Tolerance Test (MMTT) Response - Ratio of Insulin Area Under the Curve (AUC)/Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Mixed meal tolerance test (MMTT) to assess changes in function of cells making insulin. AUCinsulin/AUCglucose ratio: index of insulin secretion. Larger values reflect greater secretion adjusted for glucose in response to meal. Area under insulin concentration versus time curve and area under plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for insulin and glucose represents AUC of values plotted over time. LS means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat population (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline AUC insulin/AUC glucose value. Reporting is on the 131 participants who received either TT223 or its placebo and reflects data only from the treatment and follow-up phases of the study.|||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
2753451|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - C-Peptide Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents area under the curve (AUC) of C-peptide values when plotted over time. Larger area under the curve (AUC) values represent a greater average C-peptide value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit interaction. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline C-peptide area under the curve (AUC) value.|||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
2753504|NCT00853021|Secondary|Percentage of Patients With Neutropenia|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia|From start of treatment to 30 days after treatment||||percentage of participants|||Number
2753452|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed-meal tolerance test (MMTT) used to assess changes in function of cells that make insulin (pancreatic beta cell function). Area under the plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for glucose represents area under curve of values when plotted over time. Larger area under the curve values represent greater average glucose value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline value and at least 1 post-baseline glucose area under the curve (AUC) value.|||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
2753453|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 4-Week Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.|||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
2753454|NCT00853151|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 6-Month Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.|||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
2753455|NCT00853125|Secondary|Response Rate|Per response evaluation criteria in solid tumors criteria (RECIST v 1.0) for target lesions and assessed by MRI; Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Stable disease - not meeting criteria for response or progression.|Best responseFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.||||participants|||Number
2753456|NCT00853125|Primary|Progression-free Survival|Determined as the time from treatment with combination sunitinib with irradiated allogeneic lymphocytes to progressive disease or death whichever occurred first. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 1 year.|Study was terminated early due to slow accrual.|||days||Full Range|Median
2753457|NCT00853112|Secondary|Plasma Concentration of PF-00489791 and Sildenafil||1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5)|Data was not reported for this outcome measure because the study was terminated and as per change in planned analysis, the pharmacokinetic parameters were not to be summarized.||||||
2753458|NCT00853112|Secondary|Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose|Arterial blood samples for PaO2 and PaCO2 collected via an arterial line were assessed. PaO2 is the measure of oxygen level in the arterial blood and PaCO2 is the measure of carbon dioxide level in the arterial blood.|Baseline; 1, 4 hours post-dose on Day 1|Safety analysis set included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||mmHg||Standard Deviation|Mean
2753459|NCT00853112|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values|Criteria for clinically significant changes (changes of potential clinical concern) in ECG parameters: increase from baseline of >=30 to <60 milliseconds (msec) or >=60 msec in corrected QT interval (QTc), QT interval corrected using Fridericia's correction (QTcF) and QT interval corrected using Bazett's correction (QTcB); Increase from baseline of >= 25% (when baseline was >200 msec) or increase from baseline of >=50% (when baseline was <=200 msec) in PR interval; and Increase from baseline of >= 25% (when baseline was >100 msec) or increase from baseline of >=50% (when baseline was <=100 msec) in QRS interval. Number of participants with any clinically significant change in ECG values were reported.|Baseline up-to follow up (Day 3 to 5)|Safety analysis set included all randomized participants who received study medication.|||Participants|||Count of Participants
2753460|NCT00853112|Secondary|Number of Participants With Clinically Significant Laboratory Values|Criteria for clinically significant laboratory values:hemoglobin, hematocrit and red blood cells(less than[<]0.8*lower limit of normal[LLN]); leucocytes (<0.6*LLN/greater than[>]1.5*upper limit of normal[ULN]);platelets (<0.5*LLN></0>1.75* ULN);neutrophils, lymphocytes(<0.8*LLN></0>1.2* ULN); eosinophils, basophils, monocytes (>1.2*ULN);bilirubin (>1.5*ULN);aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(>3*ULN);creatinine, blood urea nitrogen (>1.3*ULN);glucose(<0.6*LLN></0>1.5* ULN); uric acid(>1.2*ULN);sodium(<0.95*LLN></0>1.05*ULN); potassium, chloride, calcium(<0.9*LLN></0>1.1* ULN); albumin, total protein(<0.8></0>1.2* ULN); creatine kinase(>2.0*ULN);urine red blood cells(RBCs), urine white blood cells(WBCs)(>=6 per high-powered field);qualitative urine glucose, urine ketones, urine protein, urine blood/hemoglobin(>=1); urine bacteria(>20 per high-powered field); pregnancy test, urine protein, quantitative random serum pregnancy test (>=1).|Baseline up-to follow up (Day 3 to 5)|Safety analysis set included all randomized participants who received study medication.|||Participants|||Count of Participants
2753461|NCT00853112|Secondary|Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in HR were reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2753462|NCT00853112|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in PVR and SVR were reported. PVR was calculated by: PVR (Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements).|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.|||Wood units||Standard Deviation|Mean
2753463|NCT00853112|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including PCWP, SAP, sSAP and dSAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements (except PCWP for which 1 measurement is sufficient) were performed as triplicate measurements and average was used.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.|||mmHg||Standard Deviation|Mean
2753464|NCT00853112|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including mPAP, sPAP, dPAP and RAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements were performed as triplicate measurements and average was used.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2753465|NCT00853112|Secondary|Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose|CI was calculated as: CI (liters per minute per square meter [L/min/m^2]) = CO (taken as the average of the triplicate measurements) divided by BSA. BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||L/min/m^2||Standard Deviation|Mean
2753466|NCT00853112|Secondary|Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose|SVRI is the product of SVR and BSA. SVR equals to (mean SAP subtracted by RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) equals to 0.007184 times height (cm)^0.725 times weight (kilogram) ^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in SVRI was reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
2753467|NCT00853112|Secondary|Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose|PVRI was calculated as: PVR multiplied by BSA. PVR = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = 0.007184 times height (cm)^0.725 times weight (kilogram)^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in PVRI was reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
2753468|NCT00853112|Secondary|Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose|SVRI was calculated as: SVRI (Wood units*m^2) = SVR multiplied by BSA. SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in SVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
2753469|NCT00853112|Secondary|Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose|PVRI was calculated as: PVRI (in Wood units*m^2) = PVR multiplied by BSA. PVR (in Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVRI was calculated as: SVRI (Wood units*m^2) = systemic vascular resistance (SVR) multiplied by BSA. SVR (Wood units) = (mean systemic arterial pressure [mean SAP] minus right atrial pressure [RAP]) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. PVRI and SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. For each participant the greatest reduction (GR) from baseline in PVRI and SVRI over 4-hour interval was defined as the maximum reduction (greatest decrease or smallest increase) observed at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
2753505|NCT00853021|Secondary|Percentage of Patients With Constitutional Adverse Events|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills|From start of treatment to 30 days after treatment||||percentage of patients|||Number
2754298|NCT00847405|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2753470|NCT00853112|Primary|Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose|PVRI was calculated as: PVRI (in Wood units*meter^2 [m^2]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure [mean PAP] minus pulmonary capillary wedge pressure [PCWP]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in centimeters [cm])^0.725 multiplied by (weight in kilograms [kg])^0.425. PVRI values were converted to dyne*second (s)*m^2/centimeter (cm)^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
2753471|NCT00853099|Secondary|Number of Participants With Adverse Events During the Adalimumab Treatment Period|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|221 weeks|The safety analysis set.|||participants|||Number
2753472|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 52|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|52 weeks|The safety analysis set.|||participants|||Number
2753473|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 8|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|8 weeks|The Safety Analysis Set includes all participants who received at least one dose of study medication.|||participants|||Number
2753474|NCT00853099|Secondary|Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders|An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753475|NCT00853099|Secondary|Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)|"Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753476|NCT00853099|Secondary|Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)|"The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753477|NCT00853099|Secondary|Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)|"Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753478|NCT00853099|Secondary|Percentage of Participants With Mucosal Healing|"Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52.~The endoscopy subscore ranges from zero to three as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753479|NCT00853099|Secondary|Percentage of Participants With a Clinical Response|"A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1.~The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore, based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore, based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753480|NCT00853099|Secondary|Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
2753481|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 52|Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission.|||percentage of participants|||Number
2753482|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 8 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 8|The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.|||percentage of participants|||Number
2753483|NCT00853073|Secondary|Number of Participants With Surgical Success|Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.|6 months||||Participants|||Count of Participants
2753484|NCT00853073|Primary|Intraocular Pressure (IOP)|mmHg (millimeters of mercury)|6 months||||mmHg (millimeters of mercury)||95% Confidence Interval|Mean
2753485|NCT00853047|Secondary|Number of Participants Experiencing Complete Response at Week 4|"Complete Response to treatment was defined as one of the following: 1. Less than 4 bowel movements per day; or 2. A decrease in daily bowel movements that is ≥ 50% from baseline; or 3. A positive response to the global assessment question (In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain or discomfort?) for each of the last 2 weeks of the Treatment Period."|Baseline to Week 4|The mITT Set Core Phase included all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug.|||Participants|||Count of Participants
2753486|NCT00853047|Secondary|Time to First Rescue, Short-acting Octreotide|Time to the first subcutaneous injections of rescue, short-acting octreotide was determined from the participant's daily diary.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, As per protocol only the Placebo Core Phase and Telotristat Etiprate 500 mg Core Phase were included in the analysis.|||days||95% Confidence Interval|Median
2753487|NCT00853047|Secondary|Change From Baseline in Frequency of Rescue for Short-acting Octreotide Use/Day|Participants recorded details (location and frequency of injection) of subcutaneous injections of rescue, short-acting octreotide, if taken, in the daily diary. A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.|||injections per day||Standard Deviation|Mean
2753488|NCT00853047|Secondary|Number of Participants Reporting Improvement in the Subjective Global Assessment of Symptoms Associated With Carcinoid Syndrome|"Participants were asked to answer the following question: In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort?. The number of participants who answered Yes are reported."|Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.|||Participants|||Count of Participants
2753489|NCT00853047|Secondary|Change From Baseline in Chromogranin A|Blood samples were collected for assessment of Chromogranin A level. A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.|||ng/mL||Standard Deviation|Mean
2753490|NCT00853047|Secondary|Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA)|u5-HIAA is a standard test used in clinical practice to assess the neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the Pharmacodynamic (PD) Analysis Set Core Phase, all participants who received any fraction of a dose of study drug and had a valid Baseline and at least 1 valid post-Baseline PD assessment, with data available for analysis.|||mg/24 hours||Standard Deviation|Mean
2753491|NCT00853047|Secondary|Change From Baseline in Severity of Abdominal Pain or Discomfort|Participants recorded the severity of abdominal pain or discomfort in a daily diary assessed using a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe). A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis. Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2753492|NCT00853047|Secondary|Change From Baseline in Number of Cutaneous Flushing Episodes|Participants recorded the number of daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.|||cutaneous flushing episodes||Standard Deviation|Mean
2753493|NCT00853047|Secondary|Change From Baseline in Percentage of Days Per Week Experiencing a Sensation of Urgency to Defecate|Participants recorded the sensation of urgency to defecate (Yes or No) in a daily diary. A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug with data available for analysis.|||percentage of days||Standard Deviation|Mean
2753494|NCT00853047|Secondary|Change From Baseline in Weekly Mean Stool Form|Participants recorded stool form in a daily diary using a 6-point scale (0-none,1-hard, 2-firm, 3-soft, 4-loose, 5-watery). A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the mITT Set Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.|||units on a scale||Standard Deviation|Mean
2753495|NCT00853047|Secondary|Change From Baseline in Mean Number of Bowel Movements (BMs) Per Day|Participants recorded the number of BMs per day in a daily diary. The total number of BMs per day were averaged over the 4-week period. A negative change from Baseline indicates improvement.|Baseline to Week 4|Participants from the modified Intent to Treat (mITT) Set, Core Phase, all participants who received any fraction of a dose of study drug and had at least 1 week of data recorded in the daily diary after receiving study drug, with data available for analysis.|||bowel movements/day||Standard Deviation|Mean
2753496|NCT00853047|Primary|Number of Participants With Any TEAE in the Open-Label Extension Phase|An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after receiving treatment.|Up to 180 weeks in the open-label extension phase|The Safety Set Extension Period included all participants who received at least one dose of study drug in the open-label extensions phase.|||Participants|||Count of Participants
2753497|NCT00853047|Primary|Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Drug-related TEAE in the Core Phase|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|Up to 4 Weeks Core Phase|The Safety Set Core Phase included all participants who received at least one dose of study drug in the core phase.|||Participants|||Count of Participants
2753498|NCT00853021|Other Pre-specified|T-helper Cells (Type 1,2)|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
2753499|NCT00853021|Other Pre-specified|CD25+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
2753500|NCT00853021|Other Pre-specified|CD4+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
2753501|NCT00853021|Other Pre-specified|IL-8 Levels|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
2753506|NCT00853021|Secondary|Objective Response Rate (Complete and Partial Response)|"Objective response rate to be assigned a status of PR or CR per RECIST criteria, with Complete Response (CR) referring to the disappearance of all target lesions, Partial Response (PR) referring to at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met."|4 weeks after end of treatment||||percentage of participants|||Number
2753507|NCT00853021|Primary|Progression Free Survival|Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.|From baseline (day -14) to disease progression (reported at 2 years)||||months||95% Confidence Interval|Median
2753508|NCT00852995|Secondary|Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks - the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.|||Days to Closure||95% Confidence Interval|Median
2753509|NCT00852995|Secondary|Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||units on a scale||Standard Deviation|Mean
2753510|NCT00852995|Secondary|Percentage of Participants With Complete Wound Closure at Each Visit|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test|||percentage of participants|||Number
2753511|NCT00852995|Secondary|Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13|The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.|Over the 12 week treatment period or until the wound closed, which ever occurred first.|The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.|||Responders|||Number
2753512|NCT00852995|Secondary|Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.|For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P < 0.05.|||Percent change||Standard Error|Least Squares Mean
2753513|NCT00852995|Secondary|Kaplan-Meier Probability of Non-Closure|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks - the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.|||Probability of Non-Closure|||Number
2753514|NCT00852995|Primary|The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.|For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P < 0.05.|||percent change||Standard Deviation|Mean
2753515|NCT00852969|Secondary|Change in HDL-C From Baseline to 14 Weeks||14 weeks since baseline||||mg/dl||95% Confidence Interval|Mean
2753516|NCT00852969|Primary|Change in the Flow Mediated Dilation From Baseline|Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks|14 weeks since baseline||||absolute percent change||95% Confidence Interval|Mean
2753517|NCT00852930|Primary|Whole Arm Volume Difference|Whole arm measurement to determine volume.|Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.||||Whole Arm Volume % Difference||Inter-Quartile Range|Median
2753518|NCT00852930|Secondary|Quality of Life|The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher quality of life.|Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.||||total score||Inter-Quartile Range|Median
2753519|NCT00852930|Secondary|Symptoms|Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.|Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.|Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.|||symptoms||Inter-Quartile Range|Median
2753520|NCT00852930|Primary|LDex Change-|Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.|Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.|LDex units.|||LDex||Inter-Quartile Range|Median
2753521|NCT00852917|Secondary|Dropout Rate|Reasons for withdrawal from the trial were collected|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.|||percentage of participants|||Number
2753522|NCT00852917|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference in WOMAC Physical||Standard Deviation|Mean
2753523|NCT00852917|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient's overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||participants|||Number
2753524|NCT00852917|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||mm||Standard Deviation|Mean
2753525|NCT00852917|Secondary|Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||Percentage difference in WOMAC Physical||Standard Deviation|Mean
2753526|NCT00852917|Secondary|Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||Percentage difference in WOMAC Pain||Standard Deviation|Mean
2753527|NCT00852917|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference in WOMAC Pain||Standard Deviation|Mean
2753528|NCT00852917|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||participants|||Number
2753529|NCT00852761|Secondary|Dermatology Life Quality Index (DLQI) Categories|Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.|Days 3, 8, 15||||participants|||Number
2753530|NCT00852761|Secondary|Total Dermatology Life Quality Index (DLQI) Score|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2753531|NCT00852761|Secondary|Dermatology Quality of Life - Treatment|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2753532|NCT00852761|Secondary|Dermatology Quality of Life - Personal Relationships|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2754656|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|18 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2753533|NCT00852761|Secondary|Dermatology Quality of Life - Work and School|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2753534|NCT00852761|Secondary|Dermatology Quality of Life - Leisure|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2753535|NCT00852761|Secondary|Dermatology Quality of Life - Daily Activities|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2753536|NCT00852761|Secondary|Dermatology Quality of Life - Symptoms and Feelings|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
2753537|NCT00852761|Secondary|Median Change in Psoriasis Grading Scale|Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline, Days 3, 8, 15|ITT|||unites on a scale||Inter-Quartile Range|Median
2753538|NCT00852761|Secondary|At Least a 3 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753539|NCT00852761|Secondary|At Least a 2 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753540|NCT00852761|Secondary|At Least 1 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753541|NCT00852761|Secondary|At Least a 3 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753542|NCT00852761|Secondary|At Least a 2 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753543|NCT00852761|Secondary|At Least 1 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753544|NCT00852761|Secondary|At Least a 3 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753545|NCT00852761|Secondary|At Least a 2 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
2753546|NCT00852761|Secondary|At Least 1 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3 and 8|Intent to treat (ITT)|||participants|||Number
2753593|NCT00851903|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment period (12 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population|||participants|||Number
2753547|NCT00852761|Primary|At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)|Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline to day 15|ITT|||participants|||Number
2753548|NCT00852644|Secondary|Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival|Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging|before treatment and at 1, 3, 6, and 12 months after treatment|Data were not collected and the outcome measure was not analyzed||||||
2753549|NCT00852644|Primary|Maximum Tolerated Dose - More Than 3 Centimeter Cohort.|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.|6 weeks|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.||||dose||
2753550|NCT00852644|Primary|Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort|The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort|6 weeks||||Participants|||Count of Participants
2753551|NCT00852644|Primary|Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.|6 weeks|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.||||dose||
2753552|NCT00852644|Primary|Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort|Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort|6 weeks||||Participants|||Count of Participants
2753553|NCT00852631|Secondary|Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|Day 14|The number of patient is different, because some of them withdraw/terminate during the study.|||Scores on a scale||Standard Deviation|Mean
2753554|NCT00852631|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.~Minimum value considered better is score decreased from baseline at least 30%."|From Day 1 (baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.|||Scores on a scale||Standard Deviation|Mean
2753555|NCT00852631|Secondary|Change in Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|From Day 1 (Baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.|||Scores on a scale||Standard Deviation|Mean
2753556|NCT00852592|Secondary|Global Assessment of Functioning (GAF)|The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.|6-weeks||||units on a scale||Standard Deviation|Mean
2753557|NCT00852592|Primary|SIGH-ADS Depression Score|The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
2753558|NCT00852540|Secondary|Mean Wound Size at Visits 1, 2, 3, 4, and 5|Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing data were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||centimeters squared (cm^2)||Standard Deviation|Mean
2753559|NCT00852540|Secondary|Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5|The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing Skin Infection Rating Scale scores were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||scores on a scale||Standard Deviation|Mean
2753560|NCT00852540|Secondary|Number of Participants With Therapeutic Response at Follow-up|"Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a clinical success and a microbiological success. All other combinations (other than clinical success + microbiological success) were deemed failures for therapeutic response."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|ITTB Population|||participants|||Number
2753594|NCT00851903|Secondary|Insulin Dose|Daily dose at the face-to-face visits|baseline, week 4, week 8, week 12|mITT population|||unit per kg body weight||Standard Deviation|Mean
2753741|NCT00850642|Secondary|Number of Participants With Hematology Values of PCC|The hematology parameters evaluated were white blood cells, neutrophils, hemoglobin, hematocrit, platelets and lymphocytes. The number of participants with values outside the PCC values were reported. The PCC value observed for lymphocyte was reported.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All subject population.|||Participants|||Count of Participants
2753561|NCT00852540|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTB Population|||pathogens|||Number
2753562|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTC Population. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||participants|||Number
2753563|NCT00852540|Secondary|Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population|||participants|||Number
2753564|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population|||participants|||Number
2753565|NCT00852540|Secondary|Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)|"MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was clinical success (CS)/improvement, the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a CS such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a CS."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Bacteriology (ITTB) Population: all randomized participants who took at least one dose of study medication and who had a pathogen isolated at baseline.|||participants|||Number
2753566|NCT00852540|Secondary|Number of Participants With Clinical Response at Follow-up|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Clinical (ITTC) Population: all randomized participants (par.) who took at least one dose of study medication. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||participants|||Number
2753567|NCT00852540|Secondary|Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)|"MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was clinical success (CS)/improvement, the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a CS such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a CS."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.|||participants|||Number
2753568|NCT00852540|Primary|Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.|||participants|||Number
2753754|NCT00850538|Primary|Number of Participants With Viable Specimens for Genetic Analysis||Tissue samples collected at time of surgery||||participants|||Number
2753569|NCT00852527|Primary|Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)|Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.|All OEF/OIF Veterans to receive TCRS upon enrollment in VA|Although 456 participants were consented and enrolled in the study, data for 13 participants had missing assessment data and another 5 were determined to have moderate TBI resulting in 438 cases for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2753570|NCT00852475|Secondary|Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .|Ultrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.|6 months from Baseline||||percentage of change from baseline||Standard Error|Mean
2753571|NCT00852475|Primary|Weight Changes in Veterans With MetS.||6 months from Baseline||||kg||Standard Error|Mean
2753572|NCT00852397|Other Pre-specified|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.|"TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).~TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753573|NCT00852397|Other Pre-specified|Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.|"ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.~ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753574|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.|Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]).|From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])|The efficacy analysis set was all randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2753575|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.||For 30 days after Week 24 or the discontinuation of study drug|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753576|NCT00852397|Secondary|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.|TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753577|NCT00852397|Secondary|Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.|Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753578|NCT00852397|Secondary|Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.|All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753595|NCT00851903|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|"The population analyzed consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing."|||mg/dL||Standard Deviation|Mean
2753579|NCT00852397|Primary|Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
2753580|NCT00852241|Primary|The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment||1 year|The Principle Investigator left the institution and no data is available.||||||
2753581|NCT00852202|Secondary|Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )|The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.|Baseline to Week 8|of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 53 for 1.5 to 3.0 mg Cariprazine|||Score on Scale||Standard Error|Mean
2753582|NCT00852202|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)|The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.|Baseline to Week 8|of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 54 for 1.5 to 3.0 mg Cariprazine|||Score on scale||Standard Error|Mean
2753583|NCT00852137|Secondary|Max Composite Local Skin Response (LSR) Score|Max composite Local Skin Response (LSR) score on day 3 only . The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0-24. (One vehicle treated patent had a LSR on day 1 only).|Day 3||||local skin response score||Standard Deviation|Mean
2753584|NCT00852137|Secondary|Patients With Incidence of Pigmentation and Scarring|Patients with Incidence of pigmentation and scarring, and grade of pigmentation and scarring, following study treatment through Day 57|Baseline, Day 2, 3, 8, 15, 29 and 57||||participants|||Number
2753585|NCT00852137|Secondary|Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.|Number of patients with LSR at any time point during the study above 0. The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0-24.|baseline and Day 2, 3, 8, 15, 29 and 57||||participants|||Number
2753586|NCT00852137|Secondary|Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area|Percentage (%) change in actinic keratosis (AK) lesions count at Day 57, compared to baseline, in a 25 cm^2 area within the selected treatment area.|Baseline and Day 57||||change from baseline lesion count (%)||Standard Deviation|Mean
2753587|NCT00852137|Secondary|Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area|Number of participants with complete clearence. Complete clearance rate is defined as no clinically visible actinic keratosis (AK) lesions in a 25 cm^2 area within the selected treatment area at Day 57 compared to baseline|baseline and day 57||||participants|||Number
2753588|NCT00852137|Primary|Area Under the Blood Conc. Versus Time Curve for Time 0-24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Area under the blood conc. versus time curve was calculated for time 0-24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day||||ng/mL x h||Standard Deviation|Mean
2753589|NCT00852137|Primary|Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.|Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day||||hours|||Number
2753590|NCT00852137|Primary|Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day||||ng/mL||Standard Deviation|Mean
2753591|NCT00852124|Primary|Safety of VSL#3 in Adults Asthmatics|Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.|3 months|3 people were randomized to placebo arm but no data were analyzed due to early termination of study and small number of patients enrolled.||||||
2753592|NCT00851903|Secondary|Change in Body Weight From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value|The population analyzed was the safety population with both baseline and endpoint values available|||kg||Standard Deviation|Mean
2753657|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Physician's Office Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Physician's office visits||Standard Deviation|Mean
2753596|NCT00851903|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure|||mg/dL||Standard Deviation|Mean
2753597|NCT00851903|Secondary|HbA1c: Change From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure|||percent||Standard Deviation|Mean
2753598|NCT00851903|Primary|HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)||study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had HbA1c value at study endpoint.|||percentage of participants||95% Confidence Interval|Number
2753599|NCT00851890|Secondary|Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28|Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented.|Days 1 through 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||participants|||Number
2753600|NCT00851890|Secondary|Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28|Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented.|Days 1, 5, 10, 17, 24 and 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||participants|||Number
2753601|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).|||percentage of participants|||Number
2753602|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).|||percentage of participants|||Number
2753603|NCT00851890|Secondary|Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants.|Prior to the first dose on Day 1 and Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||percentage of participants|||Number
2753604|NCT00851890|Secondary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error.|Day 28 and Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||log10 IU/mL||Standard Error|Least Squares Mean
2753605|NCT00851890|Primary|Number of Participants Having Treatment-emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:~Mild - transient and easily tolerated;~Moderate - caused discomfort and interrupted usual activities;~Severe - caused considerable interference with usual activities, may be incapacitating or life-threatening.~AEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator."|AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks)|Participants received at least 1 dose of study drug.|||participants|||Number
2753658|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Emergency Room Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Emergency room visits||Standard Deviation|Mean
2753606|NCT00851890|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Standard Deviation|Mean
2753607|NCT00851890|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Standard Deviation|Mean
2753608|NCT00851890|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng*hr/mL||Standard Deviation|Mean
2753609|NCT00851890|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||Hours||Standard Deviation|Mean
2753610|NCT00851890|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2753611|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 through Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||log10 IU/mL||Standard Error|Least Squares Mean
2753612|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 to before first dose on Day 3|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||log10 IU/mL||Standard Error|Least Squares Mean
2753613|NCT00851877|Secondary|Phase II 2-year Overall Survival|median follow-up 24 months for 34 patients|2 year|12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.|||percentage of participants||95% Confidence Interval|Number
2753614|NCT00851877|Secondary|Phase II 2-year Local Control|Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions|2 year|12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.|||percentage of participants||95% Confidence Interval|Number
2753659|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set|||hospitalizations||Standard Deviation|Mean
2753615|NCT00851877|Primary|Phase II 2-year Progression-free Survival|"Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death."|2 year|12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.|||percentage of participants||95% Confidence Interval|Number
2753616|NCT00851877|Primary|Phase I Maximum Tolerated Dose of Nab-Paclitaxel|Seven participants were assigned nab-paclitaxel in dose of 25mg/m^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m^2.|90 days|12 patients enrolled in the phase I study.|||mg/m^2|||Number
2753617|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753618|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753619|NCT00851799|Secondary|Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96|Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753620|NCT00851799|Secondary|Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96|Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753621|NCT00851799|Secondary|Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96|IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753622|NCT00851799|Secondary|Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96|hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753623|NCT00851799|Secondary|Fold Change in D-dimer From Study Entry to Weeks 48 and 96|D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
2753624|NCT00851799|Secondary|Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96|Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||uIU/dL||Inter-Quartile Range|Median
2753625|NCT00851799|Secondary|Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96|Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
2753660|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set|||hospitalizations||Standard Deviation|Mean
2753661|NCT00851721|Secondary|Pharmacoeconomics: Annual Days Lost Due to Bleeding (Work or School)||12 months ± 14 days|Intent to Treat Analysis Set|||days||Standard Deviation|Mean
2753626|NCT00851799|Secondary|Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96|Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
2753627|NCT00851799|Secondary|Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96|HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
2753628|NCT00851799|Secondary|Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96|Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
2753629|NCT00851799|Secondary|Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96|Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
2753630|NCT00851799|Secondary|Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144|Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry).|Study entry to weeks 24, 48, 96, and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.|||cell/mm^3||Inter-Quartile Range|Median
2753631|NCT00851799|Secondary|CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144|The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144.|Study entry, weeks 24, 48, 96 and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.|||cell/mm^3||Inter-Quartile Range|Median
2753632|NCT00851799|Secondary|Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96|Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753633|NCT00851799|Secondary|Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96|Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753634|NCT00851799|Secondary|Percent Change in Lean Mass From Study Entry to Week 96|Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753635|NCT00851799|Secondary|Percent Change in Trunk Fat From Study Entry to Week 96|Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753636|NCT00851799|Secondary|Percent Change in Total Limb Fat From Study Entry to Week 96|Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753637|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96|Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2755858|NCT00835861|Secondary|Number of Babies With Neonatal Hypoglycemia|Initial neonatal glucose < 40 mg/dL|Time of delivery through hospital discharge|For 1 infant in each group, the initial neonatal glucose value was missing.|||Number of babies|||Number
2753638|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96|Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753639|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96|Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257|||percent||Inter-Quartile Range|Median
2753640|NCT00851799|Secondary|Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48|The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.|Study entry, weeks 4, 24 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mm||Standard Deviation|Mean
2753641|NCT00851799|Secondary|Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, weeks 4 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||95% Confidence Interval|Mean
2753642|NCT00851799|Primary|Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, week 24|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
2753643|NCT00851799|Primary|Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)|"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.~The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors."|Study entry, week 144|Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||micron/year||95% Confidence Interval|Mean
2753644|NCT00851786|Secondary|Geometric Mean Fold Rise (GMFR) in VZV ELISpot Responses|VZV-specific cellular immune responses in peripheral blood mononuclear cells (PBMC) were tested by ELISpot assay in a subset of participants pooled across CD4 strata. GMFR is the geometric mean of the ratios of Week 6 or Week 12 post-vaccination antibody to the pre-vaccination antibody.|Entry, Week 6, Week 12|Number of participants with ELISpot results available at entry and at the post-entry week (week 6 or week 12, respectively).|||fold rise||90% Confidence Interval|Geometric Mean
2753645|NCT00851786|Secondary|VZV Antibodies as Measured by gpELISA|VZV antibody titer measured by gpELISA after one or two doses of ZOSTAVAX/placebo|Within 6 weeks following one or two doses of ZOSTAVAX|Subjects with both baseline gpELISA result and at least one post vaccination gpELISA result available|||log gpELISA antibody titer||Standard Deviation|Mean
2753646|NCT00851786|Primary|Number of Participants With Composite Safety Endpoint of the Occurrence of Serious Adverse Events (SAEs) or Division of AIDS (DAIDS) Grade 3 and 4 Signs and Symptoms, Excluding SAEs Related to Trauma|Although the study was designed as a randomized trial, it was not powered to detect safety related differences between treatment arms. The safety of ZOSTAVAX was determined by comparing the number of subjects from the active arm who experienced safety endpoint to the number from a pre-specified decision rule, which was calculated based on a similar population and calibrated using the number of safety endpoints observed from the placebo arm. The pre-specified decision rule is that ZOSTAVAX would be considered to have acceptable safety if no more than 18 subjects experience a study-defined composite safety endpoint.|During the 6 week study period after receipt of any dose of ZOSTAVAX|Subjects who received at least one dose of study vaccine/placebo|||participants|||Number
2753647|NCT00851747|Primary|Efficacy of Phosphatidylcholine and Deoxycholate Subcutaneous Injections for Localized Fat Removal.|The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits|1 year|PI left institution and no data is available.||||||
2753662|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia B Participants With Shifts in Factor IX (FIX) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):~Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)~Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)~Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)~Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set~- Hemophilia B study participants"|||Bethesda Units (BU)||Inter-Quartile Range|Median
2754299|NCT00847405|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2753648|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Pediatrics <12 Years Old|"General pain was assessed using the children's VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). Assessments were done at the screening, 6 months, and termination visits.~Scores on the children's VAS scale are presented as:~No Pain~Mild Pain~Moderate pain~Severe pain~Very severe pain~Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account.~Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||participants|||Number
2753649|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Adults and Adolescents ≥12 Years Old|"General pain was assessed using a VAS pain scale at screening, 6 months, and at termination. Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account. For the pain scale, a higher number indicates worse pain.~The visual analog scale ranges from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). A positive change from baseline indicates improvement.~Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants ≥12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
2753650|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Child's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <16 years old, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
2753651|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Parent's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - for all participants <16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
2753652|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Adults (Haem-A-QoL) ≥ 16 Years Old|"The Haem-A-QoL instrument has been developed and used in Hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & Leisure (S&L), School & Work (W&S), Dealing with Hemophilia (Dealing), Family Planning (FP), Feeling, Relationships (R'ships), Treatment, View, and Outlook for the Future (Future). A Haem-A-QoL Total Score (Total) was also calculated. For the Haem-A-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haem-A-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset for all participants ≥ 16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
2753653|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL): EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Index Scores|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.~EQ-5D Index scores based on EQ-5D questionnaire were calculated for participants ≥14 years of age, at screening, 6 months, and at termination visit. Changes in scores at 6 months and termination were also calculated.~A relatively higher score represents better quality of life."|12 months ± 14 days|HRQoL Intent-to-Treat Analysis Dataset - comprised of all participants ≥14 years of age who were randomized, had any available assessments at any available study visits (baseline, 6- month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
2753654|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Number of Days Lost (Work or School)||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Days||Standard Deviation|Mean
2753655|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Days||Standard Deviation|Mean
2753656|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Days||Standard Deviation|Mean
2753663|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia A Participants With Shifts in Factor VIII (FVIII) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):~Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)~Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)~Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)~Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set~- Hemophilia A study participants"|||Bethesda Units (BU)||Inter-Quartile Range|Median
2753664|NCT00851721|Secondary|Number of Related Thromboembolic Adverse Events (AEs)||12 months ± 14 days|Safety Analysis Set|||Related thromboembolic AEs|||Number
2753665|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) During or Within 1 Hour of Infusion Per Year||12 months ± 14 days|Safety Analysis Set|||Related AEs within/during 1hr per year||Inter-Quartile Range|Median
2753666|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) Per Year||12 months ± 14 days|Safety Analysis Set|||Related AEs per year||Inter-Quartile Range|Median
2753667|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgM Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)~- Parvovirus B19 IgM Antibody [IV] (Parvo IgM Ab)"|12 months ± 14 days|Safety Analysis Set|||participants|||Number
2753668|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgG Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)~- Parvovirus B19 IgG Antibody [IV] (Parvo IgG Ab)"|12 months ± 14 days|Safety Analysis Set|||participants|||Number
2753669|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: HIV-1/2 Antibody (Ab)||12 months ± 14 days|Safety Analysis Set|||participants|||Number
2753670|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Hepatitis A, Hepatitis B, and Hepatitis C|"Hepatitis A Virus Antibody (HAV Ab)~Hepatitis B Virus Core Antibody (HBcAb)~Hepatitis B Virus Surface Antibody (HBsAb)~Hepatitis B Virus Surface Antigen (HBsAg)~Hepatitis C Virus (HCV)"|12 months ± 14 days|Safety Analysis Set|||participants|||Number
2753671|NCT00851721|Secondary|Abnormal Thrombin-Antithrombin III (TAT) Assay Results|The normal reference range of values for TAT is 1-4.1 ug/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||ug/L||Inter-Quartile Range|Median
2753672|NCT00851721|Secondary|Abnormal Prothrombin Time Assay Results|The normal reference range of values for PT is 9.7-12.3 sec.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||seconds||Inter-Quartile Range|Median
2753673|NCT00851721|Secondary|Abnormal Prothrombin Fragment F 1.2 Assay Results|The normal reference range of values for prothrombin fragment F 1.2 is 69-229 pmol/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||pmol/L||Inter-Quartile Range|Median
2753674|NCT00851721|Secondary|Abnormal Fibrin Degradation Products (FDP) Assay Results|The normal reference range of values for FDP is 0-5 ug/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||ug/mL||Inter-Quartile Range|Median
2753675|NCT00851721|Secondary|Abnormal Fibrinogen Assay Results|The normal reference range of values for fibrinogen is 200-400 mg/dL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||mg/dL||Inter-Quartile Range|Median
2753676|NCT00851721|Secondary|Abnormal D-Dimer Assay Results|The normal reference range of values for D-dimers is <500 ng/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||ng/mL||Inter-Quartile Range|Median
2753677|NCT00851721|Secondary|Abnormal Activated Partial Thromboplastin Time (aPTT) Assay Results|The normal reference range of values for aPTT is 22.8 - 31 seconds.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||seconds||Inter-Quartile Range|Median
2753678|NCT00851721|Secondary|The Number of Bleeding Episode (BE) Which Required 1, 2, 3, or ≥4 Infusions to Control Bleeding||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set~- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."|||Bleeding Episodes (BEs)|||Number
2753679|NCT00851721|Secondary|Total Weight Adjusted Dose to Control a Bleeding Episode||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set~- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."|||Units/kg||Inter-Quartile Range|Median
2753680|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 24 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~24 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~24 hours after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~24 hours after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|24 ± 1 h post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)|||bleeding episodes|||Number
2753681|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 6 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~6 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~6 hours after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~6 hours after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|6 h ± 30 min post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)|||bleeding episodes|||Number
2753682|NCT00851721|Secondary|Assessment of Clinical Symptoms - Range of Motion (ROM)|ROM was measured using a goniometer for 3 key joints (ie, ankles, knees, and elbows) at screening, month 6, and termination (end of study visit)|12 months ± 14 days|Safety Analysis Set|||degrees||Inter-Quartile Range|Median
2753683|NCT00851721|Secondary|Assessment of Clinical Symptoms - Visual Analog Scale (VAS): Pain in Pediatrics (<12 Years Old)|"Pain caused by a bleeding episode (BE) in pediatric participants (<12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 h and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) using the children's VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (worst possible pain).~Scores on the children's VAS scale are presented as:~No Pain~Mild Pain~Moderate pain~Severe pain~Very severe pain"|12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.|||Bleeding episodes|Bleeding episodes (BEs)||Number
2753684|NCT00851721|Secondary|Assessment of Objective Clinical Symptoms- Visual Analog Scale (VAS): Pain in Adolescents and Adults (≥12 Years Old)|"Pain caused by a bleeding episode in adolescents and adults (≥12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 hours (h) and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) on the VAS pain scale in millimeters from 0 (no pain) to 100 (worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (100). Pain assessment occurred after each infusion related to single bleeding episodes. In case participants required an additional infusion within 24h, pain was assessed 6 ± 0.5 h and 24 ±1 h following the subsequent infusion.~Change in VAS scores at 6 ± 0.5 h and 24 ±1 h post-infusion were also compared relative to pre-infusion VAS scores (ie, (pre-infusion VAS score) - (post-infusion VAS score))."|Throughout the study period, 12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.|||Scores on a scale|Bleeding episodes|Inter-Quartile Range|Median
2753685|NCT00851721|Secondary|Number of New Target Joints|Target Joints are defined as ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows and hips|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||new target joints|||Number
2753686|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens: New Target Joints|"Annualized bleed rates (ABRs) were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X' = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using a two-sample, two-sided t-test.~The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||(bleeds/year)^(1/2)||Standard Deviation|Mean
2753687|NCT00851721|Secondary|Annualized Bleeding Rate for New Target Joints|Target joints are ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows, and hips; a target joint bleeding episode refers to an individual anatomical location.|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||Bleeds per year||Inter-Quartile Range|Median
2753688|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens by Bleeding Etiology, and Bleeding Type|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X' = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test.~The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%~Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:~On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician~Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period"|12 months ± 14 days|Efficacy Intent to Treat Analysis Dataset|||(bleeds/year)^(1/2)||Standard Deviation|Mean
2753689|NCT00851721|Secondary|Annualized Bleeding Rate by Treatment Regimen, Bleeding Etiology, and Bleed Type|Spontaneous includes unknown/undermined etiology|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||Bleeds per year||Inter-Quartile Range|Median
2753690|NCT00851721|Primary|Reduction in Annualized Bleeding Episode Rate (ABR) Among Participants Receiving Prophylactic Treatment as Compared to Those Treated On-demand|"Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:~On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician~Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period~Annualized rate of bleeding episodes was calculated as:~(Number of bleeding episodes/observed treatment period in days) * 365.25"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||bleeds/year||Inter-Quartile Range|Median
2753691|NCT00851682|Secondary|Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.|Ultrasound guidance of transrectal ultrasound biopsy was not attempted.|At time of treatment|Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.||||||
2755859|NCT00835861|Secondary|Maternal Weight Gain||Baseline throughout pregnancy until last prenatal visit.||||kg/week||Inter-Quartile Range|Median
2753692|NCT00851682|Primary|Improved Accuracy of Prostate Cancer Detection by MRI Scan.|Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.|At time of treatment|Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.||||||
2753693|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."|||Participants|||Number
2753694|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase A)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."|||Participants|||Number
2753695|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."|||mMU/mL||95% Confidence Interval|Geometric Mean
2753696|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase A)|Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.|||mMU/mL||95% Confidence Interval|Geometric Mean
2753697|NCT00851630|Secondary|HIV RNA Level < 50 Copies/ml|The number of subjects with plasma HIV RNA level <50 copies/ml.|104 Weeks|Intent to Treat, missing = failure.|||Participants|||Number
2753698|NCT00851630|Secondary|Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml|The number of subjects with plasma HIV RNA level <400 copies/ml.|104 Weeks|Intention to Treat Analysis, missing = failure.|||Participants|||Number
2753699|NCT00851630|Primary|Tuberculosis-immune Reconstitution Inflammatory Syndrome Events|Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions.|104 weeks|Intention to treat.|||Events|||Number
2753700|NCT00851630|Primary|Number of Serious Adverse Events (SAEs)|Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity.|104 weeks|Intention to treat.|||Events|||Number
2753701|NCT00851591|Secondary|Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.|"Milk-fat content was not measured in these samples as we had decided to close the study.~Protein content was not measured in these samples as we had decided to close the study."|day 0; day 8|0 patient samples||||||
2753702|NCT00851591|Primary|The Main Outcome Variable of This Study is the Quantity of Milk Produced.|The single value of this variable was calculated average from day 0 and day 8.|"Day 0 , Day 8"|||||||
2753703|NCT00851552|Secondary|Safety||2 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2753704|NCT00851552|Primary|Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21||at weeks 9 and 21|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2753705|NCT00851409|Secondary|"The Evaluation of Pharmacokinetic/ Pharmacodynamic (PK/PD)Parameters."|"PK/PD parameters will be based on concentration time curves after the 1st and 8th rhC1INH administration.(ratio visit 8/ visit 1, based on the area under the curve from baseline up to 4 hours after administration (AUC 0-4)"|8 weeks||||ratio||95% Confidence Interval|Geometric Mean
2753755|NCT00850499|Secondary|Overall Response Rate|The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug|||participants|||Number
2753706|NCT00851409|Primary|HAE Attacks/Week|"Prior to the treatment period, patients enrolled in the study, were asked about the amount of HAE attacks in the past 2 years, (calculated to attacks/week), this number is defined as Historical. During the treatment period, patients received a dose of 50 IU/kg of rhC1INH administered by slow IV injection over 4 to 5 minutes, once a week during an eight week period. The amount of attacks during this period is defined as Prophylaxis (calculated to attacks/week)."|8 weeks||||attacks/week||95% Confidence Interval|Mean
2753707|NCT00851357|Secondary|Number of Participants Quit for 30-days at 2-months Post Enrollment||2-months post enrollment||||Participants|||Count of Participants
2753708|NCT00851357|Primary|Number of Participants With Six-month Continuous Abstinence From Cigarettes||7 months post enrollment||||Participants|||Count of Participants
2753709|NCT00851318|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.~The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.|||units on a scale||Standard Deviation|Mean
2753710|NCT00851318|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count;~28 swollen joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity.~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~The data before study drug administration of 275-08-001 Study was utilized for Baseline.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2753711|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2753712|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2753713|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2753724|NCT00851006|Secondary|31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite|Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.|8 weeks||||ratio of PCr and total phosphorus||Standard Deviation|Mean
2754300|NCT00847405|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2753714|NCT00851318|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.~A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).|||participants|||Number
2753715|NCT00851279|Primary|Percentage of Participants Free From VT at 1 Year Post-Treatment|In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.|1 Year follow-up||||percentage of participants free from VT|||Number
2753716|NCT00851253|Secondary|Rates of Adverse Events Associated With Treatment|Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment|1 year|One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.|||Participants|||Count of Participants
2753717|NCT00851253|Primary|Duration of Local Control|Median time to local failure based on regional or distant metastatic disease|1 year|Boost subjects were not evaluable.|||number of months to local failure||Standard Deviation|Median
2753718|NCT00851084|Secondary|Immunogenicity of Intravenous (IV) Aflibercept|The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.|Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status|Participants treated with aflibercept and evaluable for antibody assessment.|||participants|||Number
2753719|NCT00851084|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs.|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|Of the total 235 patients included in the safety population, 116 patients received mFOLFOX6 and 119 patients received mFOLFOX6 + aflibercept. One patient, randomly assigned to the mFOLFOX6 arm did not receive any study treatment and was therefore excluded from the safety analyses.|||participants|||Number
2753720|NCT00851084|Secondary|Overall Survival (OS)|"Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.~The study was not powered for comparison of OS between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized. Of the 268 screened participants, 236 were randomly assigned to treatments, whereas 32 participants were screen failures.|||months|Participants|95% Confidence Interval|Median
2753721|NCT00851084|Secondary|Overall Objective Response Rate (ORR)|"Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.~Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable Patient population.|||percentage of participants||95% Confidence Interval|Number
2753722|NCT00851084|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.~The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).~Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable patient (EP) population. A total of 55 patients (32 in the mFOLFOX6 group and 23 in the mFOLFOX6 + aflibercept group) were without an event at the cutoff date for the PFS analysis by IRC.|||Months|Participants|95% Confidence Interval|Median
2753723|NCT00851084|Primary|Progression Free Survival (PFS) Rate at 12 Months|PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|12 months|Analyses of PFS rate was performed in the evaluable patient (EP) population as the primary analysis population. Overall, 9 patients from the randomized population were excluded from the EP population.|||percentage of participants||95% Confidence Interval|Number
2753725|NCT00851006|Primary|Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.]|The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission|8 weeks|"This outcome measure was not assessed in the Healthy Controls. Only subjects in treatment group were evaluated with CDRS-R and received scores."|||Units on a scale||Standard Deviation|Mean
2753726|NCT00850993|Primary|Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population|Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.|Baseline, 48 hrs|Intention-to-treat|||mg/dL||Full Range|Median
2753727|NCT00850993|Primary|Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.|The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time [(TSB - PT threshold/PT threshold) x 100%).|Baseline, 48 hours|Intent-to-treat population (ITT)|||percentage difference from PT threshold||Full Range|Median
2753728|NCT00850889|Secondary|Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity|Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14||||units on a scale||Standard Deviation|Mean
2753729|NCT00850889|Secondary|Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity|Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14||||units on a scale||Standard Deviation|Mean
2753730|NCT00850889|Secondary|Comparative Pain|A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day||||percent of participants|||Number
2753731|NCT00850889|Primary|Procedural Pain Score|Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day||||units on a scale||Standard Deviation|Mean
2753732|NCT00850759|Primary|Street-crossing Ability|average count of hits/close calls per participant in virtual environment, out of 30 crossings|post-training and again 6 months later||||number of hits/close calls||Standard Deviation|Mean
2753733|NCT00850720|Primary|NO Outcomes - Study Terminated Without Data.||Study terminated - no data.|||||||
2753734|NCT00850642|Secondary|Asthma Control Questionnaire (ACQ) Assessment|ACQ measures the adequacy of asthma control. It includes 5 questions about symptoms of asthma, 1 question about the rescue medication used and 1 about lung function (FEV1% predicted). This is a 7-item scale where the items are equally weighted and the ACQ score is the mean of 7 items which ranges from 0 to 6. 0= Well controlled and 6=extremely poorly controlled. Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Thus for ACQ a higher score indicates severe disease and a low score indicative of less severe disease.|At Day 1, Day 5 to 7 and Day 12|All Subject Population.|||Scores on scale||Standard Deviation|Mean
2753735|NCT00850642|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum: the Measurements Will Include IL-17, Neutrophil Elastase, Myeloperoxidase and IL-8|During the study conduct it was observed that the levels of IL-17, measured in both blood and sputum were below limit of quantification; for neutrophil elastase, in sputum no inference could be made as most levels were above the limit of quantification. Thus due to limited amount of data the analysis was not summarized.|Day 1 and Day 12|All Subjects Population. Collected data were below the limit of quantification, so data could not be summarized||||||
2753736|NCT00850642|Secondary|Concentration of Interleukin (IL)-17 and High-sensitivity C-reactive Protein (hsCRP) in Blood|The blood samples were collected to evaluate the concentration of IL-17 and hsCRP in blood. However due to early termination of the study, the data was not collected.|Day 1 and Day 12|All Subject Population. Data not summarized for this parameter.||||||
2753737|NCT00850642|Secondary|Concentration of LTB4 in Sputum|The concentration of LTB4 levels in sputum were evaluated. However due to early termination of the study, the data was not collected.|Day 1 and Day 12|All Subject Population. Data not collected.||||||
2753738|NCT00850642|Secondary|Percentage Change From Baseline of LTB4 Biomarker in Plasma|The plasma samples were evaluated for presence of LTB4 biomarkers. The percentage change from baseline was calculated by dividing the post-randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).|Day 1 and Day 12|All subject population.|||Percentage change||Standard Deviation|Mean
2753739|NCT00850642|Secondary|Percentage Change From Baseline Urine LTE4 Biomarker|The urine spot samples were collected from the participants at pre-dose on day 1 and trough day 12 for evaluation of LTE4 biomarker. This evaluated the level of inflammation in the airways of the asthma participants. The percentage change from baseline was calculated by dividing the post randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).|Day 1 and Day 12|All subject population.|||Percent change||Standard Deviation|Mean
2753740|NCT00850642|Secondary|Plasma Concentration of GSK2190915|The blood samples for analysis of pharmacokinetic parameters were collected at pre-dose and 2 hours post dose on Day 1 and pre-dose trough and 2 hour post dose on Day 12, to evaluate the concentration of the drug GSK2190915 in plasma.|At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hour|All Subject Population.|||Nanogram per millilitre||Standard Deviation|Mean
2753742|NCT00850642|Secondary|Number of Participants With Clinical Chemistry Values of PCC|The clinical chemistry parameters evaluated were albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium, urea, gamma glutamyl transferase, and bicarbonate. The number of participants with values outside the PCC values were reported. The PCC value observed for bicarbonate was reported.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All subject population.|||Participants|||Count of Participants
2753743|NCT00850642|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|The number of participants with abnormal ECG values were reported. The data was reported as Abnormal clinically significant (CS), abnormal not clinically significant (NCS), and No result.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All Subject Population.|||Participants|||Count of Participants
2753744|NCT00850642|Secondary|Number of Participants With Vital Sign of Potential Clinical Concern (PCC)|The vital sign measurement included measurement of systolic and diastolic blood pressure alongwith pulse rate. The PCC values reported for systolic blood pressure were < 85 millimeter of mercury (mmHg) and >160 mmHg; that for diastolic was <45 mmHg and >100 mmHg. The PCC values for pulse rate were <40 and > 110 beats per minute. The number of participants with values outside the PCC for systolic, diastolic blood pressure and vitals during the treatment duration were reported.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All subject population.|||Participants|||Count of Participants
2753745|NCT00850642|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28)|All Subject Population.|||Participants|||Count of Participants
2753746|NCT00850642|Secondary|Assessment of FEV1 on Visit 2, 3 and Visit 4|FEV1 is the amount of air which can be forcefully exhaled in 1 second. It was assessed using a spirometry. Due to early termination of the study, the data of individual participants is reported.|Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12)|All Subject population. Individual participant data reported, due to early termination of study. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Liters|||Number
2753747|NCT00850642|Primary|Percentage of Neutrophils in Induced Sputum|The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 g, or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as percentage of cells.|Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)|All Subject Population. Only those participants available at the specified time points were analyzed.|||Percentage of neutrophils||Standard Deviation|Mean
2753748|NCT00850642|Primary|The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count|The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 grams (g), or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as total cell count × 10^6 /g.|Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)|All Subject Population was defined as all participants who receive at least one dose of study medication.|||Giga cells per g||Standard Deviation|Mean
2753749|NCT00850603|Primary|Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.|GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.|Baseline (Day 0) and Day 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2753750|NCT00850603|Secondary|Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.|Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®|Day 0 to 7 days post-vaccination||||Participants|||Number
2753751|NCT00850603|Primary|Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers|Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.|Baseline to 28 days post vaccination|4-Fold rise analysis was in the per-protocol population with valid serology data|||Percentage of participants|||Number
2753752|NCT00850564|Secondary|Insulin Stimulated Glucose Utilization|Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)||||mg/kg/min||Standard Error|Mean
2753753|NCT00850564|Primary|Mean Overnight Growth Hormone|Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)|analysis of 13 participants who completed both baseline and 2 week visits|||mcg/L||Standard Error|Mean
2753756|NCT00850499|Primary|Complete Response Rate|The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug|||participants|||Number
2753757|NCT00850473|Primary|Number of Participants With Clear Anatomical Landmarks Confirmed by CT|Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography.|During PET CT scan, an average of 2 hours||||Participants|||Count of Participants
2753758|NCT00850460|Primary|Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8|Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.|||units on a scale||Full Range|Mean
2753759|NCT00850460|Primary|Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8|Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.|||units on a scale||Full Range|Mean
2753760|NCT00850421|Secondary|To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data||||||
2753761|NCT00850421|Secondary|To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data||||||
2753762|NCT00850421|Primary|To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data||||||
2753763|NCT00850395|Secondary|Number of Participants Taking Concomitant Therapy|Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).|Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.|||participants|||Number
2753764|NCT00850395|Secondary|Physician's Assessment of Efficacy|Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.|||participants|||Number
2753765|NCT00850395|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) Response|Response was defined as a HIV-1 RNA count of less than 50 copies/mL.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.|||participants|||Number
2753766|NCT00850395|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12|SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant's quality of life over that period.|Baseline, Months 6, 12|FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||units on a scale||Standard Deviation|Mean
2753767|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||participants|||Number
2753768|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2753769|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2753770|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||cells/mcL||Standard Deviation|Mean
2753771|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2753772|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3||Baseline, Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2753773|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||copies/mL||Standard Deviation|Mean
2753774|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||copies/mL||Standard Deviation|Mean
2753775|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3||Baseline, Month 3|Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||copies/mL||Standard Deviation|Mean
2753776|NCT00850343|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.~The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.|||units on a scale||Standard Deviation|Mean
2753777|NCT00850343|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count;~28 swollen joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity.~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~The data before study drug administration of 275-08-003 Study was utilized for Baseline.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|"The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used. N indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
2753778|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2753779|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2753780|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2753781|NCT00850343|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.~A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).|||participants|||Number
2753782|NCT00850200|Secondary|Percentage of Participants Who Did Not Have Disease Progression|Disease free survival as assessed with the Kaplan-Meier product limit method|4 years after beginning of radiation therapy|Patients treated with the optimal dosimetric modality|||percentage of participants||95% Confidence Interval|Number
2753783|NCT00850200|Secondary|Percentage of Participants Who Survived|Overall survival as assessed with the Kaplan-Meier product limit method.|4 years after beginning of radiation therapy|Patients treated with the optimal dosimetric modality|||percentage of participants||95% Confidence Interval|Number
2753784|NCT00850200|Primary|Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.||Immediately proceeding completion of each of the three treatment plans||||percentage of body receiving 4 Gy||Full Range|Median
2753785|NCT00850174|Secondary|AUC0-t - 10-hydroxy-carbazepine Metabolite|Results of metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753786|NCT00850174|Secondary|AUC0-inf - 10-hydroxy-carbazepine Metabolite|Results of Metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753787|NCT00850174|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Results of Metabolite for Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2753788|NCT00850174|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753789|NCT00850174|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis. AUC0-inf was not able to be estimated from all data sets.|||ng*h/mL||Standard Deviation|Mean
2753790|NCT00850174|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2753791|NCT00850135|Secondary|Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000|"For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.~Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into high and low at a cutoff of 22,000, which was the 90th percentile of AUC-130 values."|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|A total of 57 patients were enrolled from two clinical sites. Of these patients, 44 were screened with the 1-hour 50-g GCT; 9 were screened with 2-hour 75-g GTT. Complete data on secondary outcomes was available for 43 patients with 1-hour 50-g GCT and these were analyzed.|||participants|||Number
2753820|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
2755207|NCT00841659|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2753792|NCT00850135|Primary|Correlation Between Glucose AUC and Birth Weight.|"For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values AUC-110, AUC-120, AUC-130, AUC-140, and AUC-180, and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result."|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|"A total of 57 patients were enrolled from two clinical sites. Two patients did not have monitoring or delivery data.~Two patients who had an existing diagnosis of diabetes were excluded. The remaining 53 patients were analyzed."|||correlation coefficient|||Number
2753793|NCT00850096|Secondary|Overall Glycemic Control|Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo.|5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.|||mg/dl||Standard Error|Mean
2753794|NCT00850096|Primary|Continuous Glucose Monitoring (CGM)|Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.|Baseline and 5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.|||Percentage of day (24h) in euglycemia||Standard Error|Mean
2753795|NCT00850070|Secondary|Parent Global Assessment (PGA) Scale|This is a measure where parents rate their impression of their child's improvement, in a global manner.|Baseline, 8 weeks, and 16 weeks|Data was not analyzed secondary to lack of significant findings in primary outcome measures and limited data collected on this instrument. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2753796|NCT00850070|Secondary|Social Responsiveness Scale (SRS)|The SRS is a 65-item scale used to measure the severity of symptoms in ASD as they occur in natural social settings. The SRS is comprised of 1 Total scale and 5 subscales that generate raw scores that can be converted to standard T-scores (with mean of 50 and standard deviation of 10) for gender and rater type; standard scores were selected for use in this study. A total T-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of autistic disorder. A t-score of 60-75 is in the mild to moderate range and considered typical for children with mild or 'high-functioning' ASD, while a T-score of 59 or less suggests an absence of ASD symptoms. A total raw score of >75 were associated with a sensitivity value of .85 and a specificity value of .75 for ASD. Difference in scores between baseline and week 16 were used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.|||units on a scale||Standard Deviation|Mean
2753797|NCT00850070|Secondary|Aberrant Behavior Checklist (ABC) - Inappropriate Speech|Subscale assessing echolalia & other odd speech. Higher subscale scores indicate more symptoms. 4 items comprise the subscale, with range of scores from 0-4. Total score range on this subscale is 0 to 16. Scores are averaged to compute overall score. Difference in scores between baseline and week 16 were used as indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent to treat analysis|||units on a scale||Standard Deviation|Mean
2753798|NCT00850070|Secondary|Adverse Events Scale|This was not a standardized scale but a set of questions that was asked of each family - some standard and others open ended.|Every 1-2 weeks for 16 weeks|We did not specifically analyze this data but instead use it as a guide to determine if a drug should be discontinued for a particular child.||||||
2753799|NCT00850070|Secondary|Connor's Preschool ADHD Questionnaire|Conners Early Childhood, addresses child behavior for ages 2 years to 6 years with a variety of scales, including an ADHD subdomain.|Baseline, 8 weeks, and 16 weeks|Data was not analyzed secondary to lack of significant findings in primary outcome measures and limited data collected on this instrument. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2753800|NCT00850070|Secondary|Children's Yale Brown Obsessive Compulsive Scale (C-YBOCS)|The C-YBOCS is a scale is designed to rate the severity of obsessive and compulsive symptoms in children and adolescents, ages 6 to 17 years. It can be administered by a clinican or trained interviewer in a semi-structured fashion. In general, the ratings depend on the child's and parent's report; however, the final rating is based on the clinical judgement of the interviewer. Rate the characteristics of each item over the prior week up until, and including, the time of the interview. Scores should reflect the average of each item for the entire week, unless otherwise specified.|Baseline, 8 weeks, and 16 weeks|The data was not analyzed secondary to lack of significant findings in the primary outcome measure. Also, limited data collected secondary to the age range of the children we saw.The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
2753821|NCT00849901|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2753801|NCT00850070|Secondary|Vineland Adaptive Behavior Scale-II.|the Vineland-2 is a semi-structured interview designed to assess communicatino, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. Scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in the study. Raw score ranges from 0 to 108 depending on the scale. Total raw scale range is from 0 to 766. Subscale scores are averaged to create the total adaptive behavior composite. Higher subscale scores indicate more skills. Difference between baseline and week 16 was used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.|||units on a scale||Standard Deviation|Mean
2753802|NCT00850070|Secondary|Preschool Language Scale-Fourth Edition (PLS-4). Assesses Expressive and Receptive Language Skills in Ages Birth Through 6 Years, 11 Months.|Measures expressive & receptive language and total scores in ages birth to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher scores indicate better language abilities. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. For the outcome effect, the difference between baseline and 16 weeks was determined as an indicator for change.|Primary outcome assessment examined the difference in scores between baseline and week 16.|Intent-to-treat analysis; all subjects included. Difference in scores between baseline and 16 weeks was used as treatment outcome.|||units on a scale||Standard Deviation|Mean
2753803|NCT00850070|Primary|Clinical Global Impression -- Severity (CGI-S) Scale|The CGI-S assessed the number of participants with improved severity illness on the CGI-S scale. This is a summary judgment made by a trained clinician of symptom severity. It is a 7-point scale that rates the severity of the patient's illness at time of assessment with 1 - normal, not at all, to 7 - extremely ill. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Baseline, 8 weeks, and 16 weeks. Primary outcome assessment used 2 time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at number of children who improved (from markedly, severely or extremely ill to markedly, mildly or no illness) at 16-week time frame.|||participants|||Number
2753804|NCT00850070|Primary|Clinical Global Impression -- Improvement (CGI-I) Scale|The CGI-I assessed the number of participants showing much or very much improvement on the CGI-I scale. This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale from very much worse (1) to very much improved (7). Chi-square analyses were used to assess change in CHI-I scores (by group, post-test). Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weekly for 4 weeks, then monthly, with 16-week end point. Primary outcome assessment used two time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at percentage of children who improved (showing much or very much improved ratings) at 16-week time frame.|||participants|||Number
2753805|NCT00850031|Secondary|Improvement of Near Uncorrected Visual Acuity|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months||||units on a scale||Standard Deviation|Mean
2753806|NCT00850031|Primary|Improvement in Uncorrected Near Visual Acuity|Percent of subjects who achieved UCNVA of 20/40 or better.|12 months||||percentage of participants|||Number
2753807|NCT00849940|Secondary|Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.||Data collected from individual participants over 4 hour timeframe|Data not collected.||||||
2753808|NCT00849940|Secondary|Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation||Data collected from individual participants over 4 hour timeframe|Data not collected||||||
2753809|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation|The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 25.4 kg; age 0.04 - 10.2 years represent the values of the participants analyzed.|||percentage of oxygen saturation||Standard Deviation|Mean
2753810|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation|The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 24.0 kg; age 0.04 - 9.8 years represent the values of the participants analyzed.|||percentage of oxygen saturation||Standard Deviation|Mean
2756305|NCT00833690|Primary|Safety|Defined as absence of serious adverse experiences (SAEs) that warranted terminating an inosine treatment arm or the trial, as determined by the Data and Safety Monitoring Committee.|24 months||||Events|||Number
2753811|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation|"The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.~oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry."|Data collected from individual participants over 4 hour timeframe.|Weight range 3.9 - 49.5 kg; age 0.2 - 12.3 years represent the values of the participants analyzed.|||percentage of oxygen saturation||Standard Deviation|Mean
2753812|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.|||percentage of participants|||Number
2753813|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.|||percentage of participants|||Number
2753814|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.|||participants|||Number
2753815|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.|||participants|||Number
2753816|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
2753817|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0)."|Baseline through Week 10|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
2753818|NCT00849901|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
2753819|NCT00849901|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2753822|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Deviation|Least Squares Mean
2753823|NCT00849901|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2753824|NCT00849875|Secondary|Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.|Within the 31-day follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753825|NCT00849875|Secondary|Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.|Within the 31-day follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753826|NCT00849875|Secondary|Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade|The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753827|NCT00849875|Secondary|Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade|The status of each patient as regards PTT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753828|NCT00849875|Secondary|Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade|The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753829|NCT00849875|Secondary|Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade|The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753830|NCT00849875|Secondary|Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade|The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2754146|NCT00848120|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population|||percentage of participants|||Number
2753831|NCT00849875|Secondary|Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade|The status of each patient as regards hNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753832|NCT00849875|Secondary|Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade|The status of each patient as regards hKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753833|NCT00849875|Secondary|Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade|The status of each patient as regards hCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753834|NCT00849875|Secondary|Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade|The status of each patient as regards hAL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753835|NCT00849875|Secondary|Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade|The status of each patient as regards HNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753836|NCT00849875|Secondary|Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade|The status of each patient as regards HKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753837|NCT00849875|Secondary|Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade|The status of each patient as regards HCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753838|NCT00849875|Secondary|Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade|The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753839|NCT00849875|Secondary|Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade|The status of each patient as regards GGT laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753840|NCT00849875|Secondary|Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade|The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753874|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.|||participants|||Number
2753841|NCT00849875|Secondary|Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade.|The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753842|NCT00849875|Secondary|Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade|The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753843|NCT00849875|Secondary|Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade|The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
2753844|NCT00849875|Secondary|Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade|The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Subjects|||Number
2753845|NCT00849875|Secondary|Overall Survival (OS) by Gene Signature|OS was defined as the time from first treatment to the date of death. OS analysis was performed using the non-parametric Kaplan-Meier method. Each patient was censored out at the time of death.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
2753846|NCT00849875|Secondary|Progression-free Survival (PFS) After Slow Progressive Disease (SPD) by Gene Signature|PFS after initial SPD was defined and calculated as the time from the time point at which the disease was the most advanced during the treatment to either a new progression of the disease or the date to death, whichever occurred first as another secondary outcome of this study. In that case, the largest diameter during the course of treatment was to be used as reference measurement. This outcome was defined to take into account the delay to induce an active immune response and the strict rules set up in this study to allow pursuing investigational treatment in case of SPD. PFS after SPD analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
2753847|NCT00849875|Secondary|Progression-free Survival (PFS) by Gene Signature|PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
2753848|NCT00849875|Secondary|Progression-free Survival (PFS) for the Overall Population|PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
2753849|NCT00849875|Secondary|Time to Treatment Failure (TTF), by Gene Signature|TTF was defined as withdrawal from treatment with the MAGE-A3 ASCI study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
2753850|NCT00849875|Secondary|Number of Patients With Mixed Response (MxR) to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. MLs were assessed as regards matching below MxR definitions. In case of evaluability per RECIST: a) MxR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL, and = SD/PR with new lesion. In case of non-evaluability per RECIST: a) MxR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL = SD/PR with new lesion.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
2753851|NCT00849875|Secondary|Duration of Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. Stable disease was defined as follows: 1) In case of target lesions (TL) greater than or equal to (≥) 20 mm: neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as references the sum of Longest Diameter (LD) of TL recorded previously but not necessarily at baseline; 2) In case of TL both less than 20 mm and ≥ 20 mm: Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since the start of the treatment. The minimal time interval required between 2 measurements for determination of SD was at least 12 weeks.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
2753852|NCT00849875|Secondary|Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. TLs and NTLs were assessed as regards matching or not SD-related definitions, 1) SD definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria for TLs >= 20 mm and TLs both >= and < 20 mm: a) for TLs: SD = Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since treatment start. and b) for NTLs: SD = Persistence of one or more NTL; 2) following below criteria for TLs < 20mm e. a. a) for TLs: PR/SD = Neither sufficient shrinkage to qualify for CR nor sufficient increase, to qualify for PD taking as references the smallest sum LD since treatment start, and b) for NTLs: PR/SD = Persistence of one or more NTL.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||patients|||Number
2753853|NCT00849875|Secondary|Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment|Response assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs), and followed up until disease progression. Up to 5 MLs per organ & 10 in total were identified as TLs and measured at baseline, selected based on size (those with the longest diameter [LD]) and measurability; a sum of LDs for all TLs was calculated and reported as baseline sum LD, which was used to characterize objective tumor response (OR), OR being defined as either complete response (CR) and/or partial response (PR) post MAGE-A3 ASCI treatment. After identification, MLs and TLs were assessed as regards CR and PR definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR = Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis; PR = At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||patients|||Number
2753854|NCT00849875|Primary|Anti-MAGE-A3 Antibody Concentrations (CMI)|Analysis of MAGE-A3 cellular response was not performed and data were not collected..|Post Dose 4 at Week 13 (W13).|||||||
2753855|NCT00849875|Primary|Number of Patients With Treatment Response for Anti-PD|Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 100 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||Patients|||Number
2753856|NCT00849875|Primary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were presented ad geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL).|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2753857|NCT00849875|Primary|Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies|Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||Patients|||Number
2753858|NCT00849875|Primary|Anti-MAGE-A3 Antibody Concentrations|Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL)|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2753859|NCT00849875|Primary|Number of Seroconverted Patients for Melanoma Antigen (Anti-MAGE-A3)|Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27.|Post Dose 4 at Week 13 (W13).|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
2753875|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.|||participants|||Number
2756306|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Baseline Visit||||mg/dL||Standard Deviation|Mean
2753860|NCT00849875|Primary|Number of Patients Reported With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.|During the entire study period, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
2753861|NCT00849875|Primary|Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade.|The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the treatment.|Within the 31-day (Days 0-30) post-administration period.|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
2753862|NCT00849862|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2753863|NCT00849862|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2753864|NCT00849862|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
2753865|NCT00849810|Primary|Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.||4 weeks (pre- and post-treatment)||||mm HG||Standard Deviation|Mean
2753866|NCT00849797|Secondary|AUC0-t - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753867|NCT00849797|Secondary|AUC0-inf - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753868|NCT00849797|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2753869|NCT00849797|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753870|NCT00849797|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2753871|NCT00849797|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2753872|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.|||percentage of participants|||Number
2753873|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.|||percentage of participants|||Number
2753910|NCT00849290|Primary|Safety of APC8015F by Review of Reported Adverse Events|All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.|periodically over 24 months|All participants who received at least one infusion of APC8015F|||participants|||Number
2753876|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
2753877|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0)."|Baseline through Week 10|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
2753878|NCT00849693|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
2753879|NCT00849693|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2753880|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
2753881|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
2753882|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2753883|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
2753884|NCT00849693|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2753931|NCT00849121|Secondary|The Number of Participants Who Are Metastasis-free at One Year.|The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm. CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present.|one year from study entry||||participants|||Number
2753885|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen|"Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).~No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious."|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.||||||
2753886|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen|Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.||||||
2753887|NCT00849680|Primary|Number of Participants With Laboratory Adverse Experiences|"Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.~All laboratory AEs were collected up to 29 days after any vaccine dose."|up to 260 weeks after first vaccination|Participants administered at least one dose of study vaccine. One participant who was lost to follow-up, and another one participant who discontinued as he comply with the protocol are not included.|||Participants|||Number
2753888|NCT00849680|Primary|Number of Participants With Adverse Experiences|"Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs.~Systemic and Laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body.~Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose."|up to 260 weeks after first vaccination||||Participants|||Number
2753889|NCT00849524|Secondary|Determine Pharmacodynamic Parameters in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.||||||
2753890|NCT00849524|Secondary|Determine the Safety of Repeat Administration of Ad-ISF35 Injected Directly Into Lymph Nodes of Patients With CLL/SLL.||2 years (evaluation will be approx. 1 year per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.||||||
2753891|NCT00849524|Primary|Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.||||||
2753892|NCT00849485|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2753893|NCT00849485|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
2753894|NCT00849485|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
2753895|NCT00849472|Secondary|Number of Participants With Recurrence Events|The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population, excluding participants with recurrence before study entry|||participants|||Number
2753896|NCT00849472|Secondary|Number of Participants With the Indicated Radiotherapy-related Complications||up to 24 months after study entry|Treated Population|||participants|||Number
2753897|NCT00849472|Secondary|Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods|The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges.|up to 24 months after study entry|Treated Population. Data are presented for only those participants who remained in the study during the indicated period and had their blood drawn for assessment.|||participants|||Number
2753898|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)|Treated Population: Only those members of the Treated Population who started the postoperative pazopanib period were assessed.|||Participants|||Number
2753899|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).|Treated Population|||Participants|||Number
2753900|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)|Treated Population: all participants who entered the study and received at least one dose of any study medication|||Participants|||Number
2753901|NCT00849472|Secondary|Invasive Recurrence-free Interval (IRFI)|IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population. Participants with recurrence before study entry were excluded from analysis.|||months||95% Confidence Interval|Median
2753902|NCT00849472|Secondary|Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)|Evaluable Population|||Participants|||Number
2753903|NCT00849472|Secondary|Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry|Evaluable Population|||Participants|||Number
2753904|NCT00849472|Secondary|Number of Participants With Pathologic Complete Response (pCR) in the Breast|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen.|From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)|Evaluable Population|||Participants|||Number
2753905|NCT00849472|Primary|Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.|From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)|Evaluable Population: all participants who entered the study and received at least one dose of pazopanib.|||Participants|||Number
2753906|NCT00849381|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes|The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.|During the entire study period (up to Month 12)|The analysis was based on the subjects with positive pregnancy results in the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of Cervarix vaccine in this study and for whom data were available.|||Subjects|||Number
2753907|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire study period (up to Month 12)||||Subjects|||Number
2753908|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: Results from one center where compliance issues were discovered are presented also separately."|During the entire study period (up to Month 12)||||Subjects|||Number
2753909|NCT00849290|Secondary|To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response||periodically over 24 months|||||||
2753983|NCT00848744|Secondary|The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning.||4 Weeks|Data were not collected.||||||
2753911|NCT00849251|Primary|Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1). [Dexamethasone MTD]|If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure.|Up to 90 days after initiation of study treatment|Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure.|||mg|||Number
2753912|NCT00849251|Primary|Disease Response Rate (Cohort II)|Disease response using Blade Multiple Myeloma Response Criteria in newly diagnosed (Cohort II) patients who completed at least one cycle of treatment. There were 24 evaluable patients in Cohort II.|up to 28 days after last cycle of treatment|Newly diagnosed patients (cohort II)|||Participants|||Count of Participants
2753913|NCT00849251|Primary|Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin]|If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the different Unit of Measure.|Up to 90 days after initiation of study treatment|Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that the MTD for dexamethasone is in a separate table due to the different dosing unit.|||mg/m2|||Number
2753914|NCT00849212|Secondary|Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF|The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards. This was calculated using the last observation carried forward (LOCF) method.|Baseline (Day -28 to Day 0), Week 1 to Week 10|"Efficacy analysis set:~Population after excluding : (a) Patients who do not meet the inclusion criteria, (b) Patients who meet the exclusion criteria which affect efficacy evaluation of E2007, (c) Patients untreated,(d) Patients with no evaluable data on efficacy,(e) Patients with <80% treatment compliance"|||Percent change||Full Range|Median
2753915|NCT00849212|Primary|Maximum Tolerated Dose (MTD)|MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.|10 weeks (Titration and Maintenance Periods)|Safety analysis set|||Participants|||Number
2753916|NCT00849186|Secondary|Response Rate After 90 Days of Treatment With SM||90 days|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
2753917|NCT00849186|Primary|Safety of Surgery After 90 Days of Treatment With SM|Incident Rate: Intraoperative Complication Rate|90 days|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
2753918|NCT00849186|Primary|Safety of Sunitinib Malate (SM)|Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.|90 days|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
2753919|NCT00849147|Secondary|Infections|Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.|Measured at Year 1|36 patients incurred a total number of 108 infection events.|||participants|||Number
2753920|NCT00849147|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
2753921|NCT00849147|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.|Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
2753922|NCT00849147|Secondary|Chronic GVHD||Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
2753923|NCT00849147|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100||||percentage of participants||95% Confidence Interval|Number
2753924|NCT00849147|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56||||participants|||Number
2753925|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 50K|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
2753926|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 20K|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
2753927|NCT00849147|Secondary|Secondary Graft Failure|Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.|Measured at Day 100||||participants|||Number
2753928|NCT00849147|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements.|Measured at Day 67||||participants|||Number
2753929|NCT00849147|Secondary|Neutrophil Recovery|Cumulative incidence of neutrophil recovery >500/μL at day +56|Measured at Days 28, 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
2753930|NCT00849147|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1||||percentage of participants||95% Confidence Interval|Number
2753932|NCT00849121|Secondary|The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.|The number of subjects who experience at least a two-fold increase in the PSA doubling time will be documented for each study arm. The PSA doubling time will be calculated using all PSA values obtained starting on Treatment Day 0 and continuing to end of treatment period and compared to the PSA doubling time collected at study entry prior to beginning study treatment.|Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years||||participants|||Number
2753933|NCT00849121|Primary|Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.|The number of patients with a T-cell immune response will be determined for each study arm. An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index.|Baseline and 1 year.||||participants|||Number
2753934|NCT00849121|Primary|Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.|The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution. The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm. The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms.|From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years||||participants|||Number
2753935|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by specificity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing Visit|intent to treat, received at least one dose of BMS747158|||Proportion of True Negative Cases|||Number
2753936|NCT00849108|Primary|Cohort 1: Determination of Ratio of Stress Dose to Rest Dose|The stress flurpiridaz dose for subsequent same-day rest-stress efficacy studies was determined as a multiple of the rest dose by computer modeling. Images derived only from rest flurpiridaz administration were blended using image analysis with images derived only from administration of flurpiridaz following exercise or adenosine stress. The blending fraction that resulted in negligible change in reader interpretation of defect severity was determined for each subject. The minimum value that met this criterion for all subjects was used to calculate the ratio of the stress dose to the rest dose as a function of the delay between administration of the two doses for both adenosine stress and exercise stress separately. No statistical analysis was performed.|Dosing visit|Subjects with demonstrated partially or completely reversible defects on prior SPECT who received at least one stress and one rest dose of flurpiridaz F 18, on separate days.|||Fraction of rest added to stress image|||Number
2753937|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by sensitivity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing visit|intent to treat, received at least one dose of BMS747158|||Proportion of True Positive Cases|||Number
2753938|NCT00849108|Primary|Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product|The rest flurpiridaz dose to be used for subsequent efficacy studies was determined by a modeling method that simulated a range of injected doses using a single fixed injected dose at rest in each subject and a range of acquisition durations. From this, a dose acquisition time product (DATP was determined for each subject that specified the minimal dose for a given acquisition duration that yielded an image in that subject that was negligibly affected by photon counting statistics. Descriptive statistics were used to identify an appropriate rest dose for the population. No other statistical tests were performed|Dosing visit|Intent to treat, received at least one rest dose of BMS 747158|||MBq X Minutes||Standard Deviation|Mean
2753939|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Kilograms||Standard Deviation|Mean
2753940|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
2753941|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
2753942|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Participants|||Number
2753943|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2753944|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2753945|NCT00849056|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
2753946|NCT00849056|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2753947|NCT00849056|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles).|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2753948|NCT00849017|Secondary|Albiglutide Plasma Concentration at Weeks 8 and 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2753949|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participant who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameters of insulin, proinsulin. The MM tolerance test was performed only in those participants who additionally consented to participate in.|||picomoles/Liter (pmol/L)||Standard Error|Least Squares Mean
2753984|NCT00848744|Primary|Physician Global Assessment|Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).|28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).|Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.|||units on a scale||Standard Deviation|Mean
2753950|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of glucose. The MM tolerance test was performed only in those participants who additionally consented to participate in.|||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
2753951|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid Baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of C-peptide.|||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
2753952|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Kilograms||Standard Deviation|Mean
2753953|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
2753954|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
2753955|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Participants|||Number
2753956|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2753957|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2753958|NCT00849017|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|IIT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
2753959|NCT00849017|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2753960|NCT00849017|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2753961|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP_1_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented are an average of the data collected on Day 1 and Day 8 of each treatment period. Only those participants contributing data at the indicated time points were analyzed.|||RNA copies detected per 50 ng total RNA||95% Confidence Interval|Geometric Mean
2753962|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented for each period are an average of the data collected on Day 1 and Day 8 of each period. Only those participants contributing data at the indicated time points were analyzed.|||Copies of RNA detected per 50ng of total||95% Confidence Interval|Geometric Mean
2753963|NCT00848965|Secondary|Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge)|GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2753964|NCT00848965|Secondary|Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|The eye symptom score (total score of 0 [none] to 9 [severe]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2753965|NCT00848965|Secondary|Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||grams (g)||Standard Deviation|Mean
2754147|NCT00848120|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population|||percentage of participants|||Number
2753966|NCT00848965|Secondary|Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||Milliliters per second (mL/s)||Standard Deviation|Mean
2753967|NCT00848965|Primary|Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC)|The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population: all participants randomized to receive at least one dose of study treatment. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2753968|NCT00848926|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||days||Full Range|Median
2753969|NCT00848926|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2753970|NCT00848926|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline|||percent of participants||95% Confidence Interval|Number
2753971|NCT00848926|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2753972|NCT00848926|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
2753973|NCT00848926|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
2753974|NCT00848926|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment|||participants|||Number
2753975|NCT00848926|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 6 years|Intention to treat|||months||95% Confidence Interval|Median
2753976|NCT00848926|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 4 years|Intention to treat|||months||95% Confidence Interval|Median
2753977|NCT00848926|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 4 years|Participants with complete remission among the intention to treat population|||months||95% Confidence Interval|Median
2753978|NCT00848926|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 4 years|Participants with objective response among the intention to treat population|||months||95% Confidence Interval|Median
2753979|NCT00848926|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
2753980|NCT00848926|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
2753981|NCT00848783|Secondary|Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients|Secondary outcome measure was not analyzed as study was terminated|every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years|Secondary outcome measure was not analyzed as study was terminated||||||
2753982|NCT00848783|Primary|Number of Patients With One-year Recurrence-free Survival|This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.|1 year|Based on intent-to-treat population.|||participants|||Number
2753985|NCT00848718|Secondary|Number of Participants Who Had a Tumor Response of Complete Response (CR) or Partial Response (PR)|Tumor response was assessed using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions and Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. The number of participants who had a tumor response of either CR or PR is presented.|Up to approximately 4 months (6 cycles)|All participants who received at least one dose of study treatment and had measurable disease at baseline.|||Participants|||Count of Participants
2753986|NCT00848718|Primary|Area Under the MK-2206 Concentration Versus Time Curve From Time Zero to 48 Hours Postdose (AUC 0-48h)|Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 AUC0-48h after Dose 1. The AUC0-48h after Dose 1 is presented.|At designated time points on Cycle 1 Day 1 (Up to 48 hours)|All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed|||nmol•hr/L||Standard Deviation|Mean
2753987|NCT00848718|Primary|Minimum Plasma Concentration of MK-2206 (Ctrough)|Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 Ctrough after Dose 1. The Ctrough after Dose 1 is presented and is the 48-hour postdose concentration.|At designated time points on Cycle 1 Day 1 (Up to 48 hours)|All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed|||nmol/L||Standard Deviation|Mean
2753988|NCT00848718|Primary|Time to Maximum Plasma Concentration of MK-2206 (Tmax)|Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Tmax after Dose 1. The Tmax of MK-2206 after Dose 1 will be presented.|At designated time points on Cycle 1 Day 1 (Up to 96 hours)|All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed|||hours||Full Range|Median
2753989|NCT00848718|Primary|Maximum Plasma Concentration of MK-2206 (Cmax)|Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Cmax after Dose 1. The Cmax of MK-2206 after Dose 1 will be presented.|At designated time points on Cycle 1 Day 1 (Up to 96 hours)|All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed|||nmol/L||Standard Deviation|Mean
2753990|NCT00848718|Primary|MTD of MK-2206 Administered Once Every Week (QW) in Combination With Erlotinib|Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.|Cycle 1 (up to 21 days)|All participants who received MK-2206 QW+erlotinib and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.|||mg|||Number
2753991|NCT00848718|Primary|MTD of MK-2206 Administered QOD in Combination With Erlotinib|Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.|Cycle 1 (up to 21 days)|All participants who received MK-2206 QOD+erlotinib and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.|||mg|||Number
2753999|NCT00848549|Secondary|Time to Drop-out Due to Adverse Event (AE)|"Adverse events in study subjects included any change in the subject's condition.~This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF)."|Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)|310 ITT Population (33 participants were discontinued in the Zonisamide arm and 35 were discontinued in the Carbamazepine arm; these were the participants evaluated for this outcome)|||Days||Standard Deviation|Mean
2753992|NCT00848718|Primary|MTD of MK-2206 Administered Q3W in Combination With Docetaxel|Participants received MK-2206 (90, 135, or 200 mg) administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.|Cycle 1 (up to 21 days)|All participants who received MK-2206 Q3W+docetaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.|||mg|||Number
2753993|NCT00848718|Primary|MTD of MK-2206 Administered QOD in Combination With Docetaxel|Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.|Cycle 1 (up to 21 days)|All participants who received MK-2206 QOD+docetaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.|||mg|||Number
2753994|NCT00848718|Primary|MTD of MK-2206 Administered Every Three Weeks (Q3W) in Combination With Carboplatin and Paclitaxel|Participants received MK-2206 (90, 135, or 200 mg) administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.|Cycle 1 (up to 21 days)|All participants who received MK-2206 Q3W+carboplatin+paclitaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.|||mg|||Number
2753995|NCT00848718|Primary|Maximum Tolerated Dose (MTD) of MK-2206 Administered Every Other Day (QOD) in Combination With Carboplatin and Paclitaxel|Participants received MK-2206 (45 or 60 mg) administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a dose limiting toxicity (DLT). DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.|Cycle 1 (Up to 21 days)|All participants who received MK-2206 QOD+carboplatin+paclitaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.|||mg|||Number
2753996|NCT00848718|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1|A DLT was any of the following deemed drug related by investigator and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria: Grade (G)4 hematologic toxicity lasting ≥7 days; G4 thrombocytopenia; G3 or 4 febrile neutropenia and/or infection requiring treatment; G3, 4, 5 non-hematologic toxicity(with the exception of G3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia that as a result of inadequate compliance with supportive care measures; alopecia, inadequately treated hypersensitivity reactions G3 elevated transaminases of ≤1 week in duration); adverse experience (AE) leading to dose reduction; unresolved toxicity causing ≥3 week delay in treatment; ≥G3 hyperglycemia; persistent increases in QTc interval; clinically significant bradycardia; and missing MK-2206 doses due to toxicity. The number of participants who experienced a DLT is presented.|Cycle 1 (Up to 21 days)|All participants that have received one dose of study treatment|||Participants|||Count of Participants
2753997|NCT00848549|Secondary|Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.|Weeks 0, 26, 52, 78 and 117|ITT Population|||Score on a scale||Standard Deviation|Mean
2753998|NCT00848549|Secondary|Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase|The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.|Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)|310 ITT Population|||Percentage of Participants||95% Confidence Interval|Number
2754200|NCT00847665|Secondary|Workload of Nurses|Time actually spent to manual repositioning by nurses team, in minutes/day|icu length of stay||||minutes per day||Inter-Quartile Range|Median
2754000|NCT00848549|Secondary|Time to Drop-out Due to Lack of Efficacy|Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.|Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)|310 ITT Population (combined ITT Population from basecore study and extension phase). 24 participants were discontinued in each arm due to lack of efficacy; these were the participants that were evaluated in this outcome.|||Days||Standard Deviation|Mean
2754001|NCT00848549|Primary|Percentage of Participants Remaining in the Study at Each Visit|The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.|At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months|The Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of investigational product(IP)|||Percentage of Participants||95% Confidence Interval|Number
2754002|NCT00848536|Primary|Mean Intraocular Pressure at 4:00 pm|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 4:00 pm)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.|||mmHg||Standard Error|Least Squares Mean
2754003|NCT00848536|Primary|Mean Intraocular Pressure at 11:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 11:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.|||mmHg||Standard Error|Least Squares Mean
2754004|NCT00848536|Primary|Mean Intraocular Pressure at 9:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 9:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.|||mmHg||Standard Error|Least Squares Mean
2754005|NCT00848510|Secondary|Progression-Free Survival (PFS) Time|PFS was defined as the time from first study drug intake until radiological progression (based on RECIST Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Subjects without event were censored on the date of last tumor assessment. Investigator read was the assessment of all imaging by the treating physician at the local trial site.|Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration)|The safety analysis set included all subjects who received at least one dose of IMP administration.|||months||Full Range|Median
2754006|NCT00848510|Primary|Whole Tumor Volume and Enhancing Tumor Volume|Tumor volume (three-dimensional measurement) and the enhancing fraction of the tumor, which provides a gross measure of the proportion of the tumor that has a measurable level of perfusion, were assessed using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
2754007|NCT00848510|Primary|Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60)|IAUC 60 was used to give a gross indication of the delivery and uptake of contrast agent within the tumor (indicating the degree of perfusion and endothelial permeability. IAUC60 was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||(Millimoles/liter)*sec||Standard Deviation|Mean
2754008|NCT00848510|Primary|Blood Plasma Volume and Extravascular/Extracellular Volume|Blood plasma volume and extracellular/extravascular volume was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||milliliter||Standard Deviation|Mean
2754009|NCT00848510|Secondary|Number of Subjects With Positive Binding Abituzumab Antibodies|Subjects were defined as abituzumab positive if at least one positive result of antibodies against abituzumab was observed. In all other cases, subjects were defined as abituzumab negative.|Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration)|"The immunogenicity analysis set included all subjects who received at least one dose of study drug administration and provided sufficient data from the antibodies samples. 'N' (number of subjects analyzed) signifies the subjects evaluable for this outcome measure. n signifies the number of subjects evaluable for each time point, respectively."|||Subjects|||Number
2754010|NCT00848510|Secondary|Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score|The number of subjects who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.|Up to 4 weeks after last dose administration|The safety analysis set included all subjects who received at least one dose of IMP administration.|||Subjects|||Number
2754011|NCT00848510|Secondary|Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit|"Tumor response was assessed by the Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria. Tumor response was defined as the presence of a best overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: At least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions. The qualification of a CR or of a PR needed a confirmation by a second computed tomography (CT) scan at least 4 weeks after the first scan. Best overall response was derived programmatically as the best response recorded from the first investigation medicinal product administration until disease progression. Clinical benefit was defined as the presence of a best overall response of complete response or partial response or stable disease lasting at least 6 weeks."|Up to 4 years|The full analysis set included all subjects who received at least one dose of IMP administration. “N” signifies the total number of participants evaluable for this outcome measure. Same subjects may be reported in more than one category.|||Subjects|||Number
2754012|NCT00848510|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial treatment until 30 days after last administration of trial treatment.|The safety analysis set included all subjects who received at least one dose of IMP administration.|||Subjects|||Number
2754013|NCT00848510|Primary|Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls|Volume transfer coefficient was defined as the volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow. Volumetric transfer coefficient was measured by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). DCE-MRI is a noninvasive quantitative method of investigating microvascular structure and function by tracking the pharmacokinetics of injected low molecular weight contrast agents as they pass through tumor vasculature.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||min^-1||Standard Deviation|Mean
2754014|NCT00848510|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|Toxicity was graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring during the first 4 weeks of treatment (that is, until the beginning of Week 5, with the exception of Grade 3 asymptomatic increase in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase [ALP]) returning to Baseline within 7 days.), at any dose level, for which a causal relationship to the investigative medicinal product could not be ruled out by the Investigator and/or the Sponsor.|Up to Week 4|Dose escalation analysis set included all subjects in the safety analysis set who experienced any DLT during the DLT observation period, regardless of the number of investigational medicinal product (IMP) administrations and subjects who received the IMP at Weeks 1, 3, and 5 for Cohort 1 and at Weeks 1 and 3 for all other cohorts.|||Subjects|||Number
2754015|NCT00848497|Secondary|Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.|EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better|Basline and 6 months|"Baseline = 98~5 months = 87"|||units on a scale|||Number
2754016|NCT00848497|Secondary|Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.|"ADAM scores of one evaluated patient. ADAM is 10 questions (yes or no answers) and if you answer yes to question 1 or 7 or yes to any 3 questions you are said to test positive to the ADAM questionnaire."|Baseline and 6 months|Baseline = Positive 5 months = Positive|||number of yes answers|||Number
2754017|NCT00848497|Secondary|Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.|There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function|Baseline and 6 months|Baseline = 5 5 months = 6|||units on a scale|||Number
2754018|NCT00848497|Primary|Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.|SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED|Baseline and 6 months|Baseline = 0 5 months = 0|||units on a scale|||Number
2754019|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
2754020|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score|The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
2754021|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
2754022|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score|The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
2754023|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score|CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively.|Baseline and week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
2754024|NCT00848484|Primary|Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment|The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
2754025|NCT00848393|Secondary|ABAS-II|The ABAS-II is designed to evaluate whether an individual displays various functional skills necessary for daily living without the assistance of others. Thus, this instrument focuses on independent behaviors and measures what an individual actually does, in addition to measuring what he or she may be able to do. In addition, the ABAS-II focuses on behaviors an individual displays on his or her own, without assistance from others. The Parent/Primary Caregiver Form is a comprehensive, diagnostic measure of the adaptive skills that have primary relevance for the functioning of infants, toddlers, and preschoolers in the home and other settings, and can be completed by parents or other primary care providers. Each composite or domain score is determined by summing the appropriate scaled scores and then determining its equivalent composite or domain score by looking it up in a table located in the manual.The range for all scores is 50-150, with a higher score equaling a better outcome.|1-4 yrs post-surgery|Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.|||units on a scale||Standard Deviation|Mean
2754026|NCT00848393|Secondary|Stanford-Binet Cognitive Ability|The Stanford-Binet Intelligence Scale is now in its fifth edition (SB5) and was released in 2003. It is a cognitive ability and intelligence test that is used to diagnose developmental or intellectual deficiencies in young children. The test measures five weighted factors and consists of both verbal and nonverbal subtests. The five factors being tested are knowledge, quantitative reasoning, visual-spatial processing, working memory, and fluid reasoning. Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150). Higher scores suggest a higher level of functioning related to each category.|1-4 yrs post-surgery|Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.|||units on a scale||Standard Deviation|Mean
2754027|NCT00848393|Primary|Stress Hormone Levels|Cortisol, epinephrine, and norepinephrine assayed by enzyme-linked immunosorbent assay (ELISA).|Blood draws to measure stress hormone levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.||||ng/mL||Standard Deviation|Mean
2754054|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm||Standard Deviation|Mean
2754028|NCT00848393|Primary|Stanford-Binet Intelligence Scales|The Stanford-Binet test evaluates the overall IQ score from the assessment of cognitive ability. The test consists of 15 subtests, grouped into the four area scores. Six subtests are administered to all age levels. The subtests are: Vocabulary, Comprehension, Pattern Analysis, Quantitative, Bead Memory, and Memory for Sentences. Number of tests administered and test difficulty are based on the test taker's age and performance on subtest measuring word knowledge. The word knowledge subtest is given to all test takers and is the first subtest administered. A score of 100 is in the normal or average range. Higher scores suggest a higher level of functioning related to each category. (University of Cincinnati, 2003) Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150).|1-4 yrs. post-surgery|Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.|||IQ||Standard Deviation|Mean
2754029|NCT00848393|Primary|Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator.||Time of intubation to extubation (variable)||||Hours||Full Range|Median
2754030|NCT00848393|Primary|Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay.||Hospital admission to discharge from CTICU (average of 2-4 days)||||Days||Full Range|Median
2754031|NCT00848393|Primary|ACTH and Cytokine Levels|N = 48 n = 16 (LDF); n = 17 (HDF); n = 15 (LDF + Dex) ACTH assayed by enzyme-linked immunosorbent assay (ELISA); Cytokine levels in plasma were measured using the Immulite automated chemiluminometer. Measured cytokines include interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-α.|Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.||||pg/mL||Standard Deviation|Mean
2754032|NCT00848367|Secondary|Depression Symptoms|Early response to treatment is indicated by a reduction in depression symptoms measured by The Beck Depression Inventory II (BDI-II; Beck, Steer, & Brown, 1996). The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The range for this scale is 0-63. Higher scores represent more depressive symptoms. We included cases that were missing up to 8 missing items and calculated scores for participants with missing items by taking the weighted mean and multiplying by 21.|Pre and Post treatment, 6 months and 1 year||||units on a scale||Standard Deviation|Mean
2754033|NCT00848367|Primary|Frequency of Binge Eating in the Past 28 Days||Pre and Post treatment, 6 months and 1 year||||days||Standard Deviation|Mean
2754034|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754035|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754036|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754037|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754201|NCT00847665|Secondary|ICU Mortality|ICU mortality (number of death in ICU)|ICU length of stay (an average of 28 days)||||participants|||Number
2754038|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754039|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754040|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754041|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754042|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754043|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754044|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754353|NCT00846807|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||Percentage of participants||95% Confidence Interval|Number
2754045|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754046|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754047|NCT00848354|Secondary|Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mg / dL||Standard Error|Least Squares Mean
2754048|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm/hour||Standard Deviation|Mean
2754049|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm/hour||Standard Error|Least Squares Mean
2754050|NCT00848354|Secondary|Change From Baseline in Erosion Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2754051|NCT00848354|Secondary|Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2754052|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm||Standard Deviation|Mean
2754053|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm||Standard Error|Least Squares Mean
2754657|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754055|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm||Standard Error|Least Squares Mean
2754056|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm||Standard Deviation|Mean
2754057|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm||Standard Error|Least Squares Mean
2754058|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||min||Standard Deviation|Mean
2754059|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||min||Standard Error|Least Squares Mean
2754060|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754061|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754062|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754063|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754064|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754065|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754066|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754067|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754068|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754069|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754070|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754071|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754072|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754073|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754074|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754075|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754076|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754077|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754078|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:~DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6~DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754079|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:~DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6~DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754080|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754081|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754082|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:~DAS-value ≤3.7 and DAS-improvement from Baseline >0.6~DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754083|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:~DAS-value ≤3.7 and DAS-improvement from Baseline >0.6~DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754084|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754085|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754086|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754087|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754088|NCT00848354|Secondary|Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754089|NCT00848354|Secondary|Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754090|NCT00848354|Secondary|Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754091|NCT00848354|Secondary|Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754092|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754093|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754121|NCT00848198|Secondary|Referent Values for Ocular Surface Disease Index|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment and the index is calculated based on the responses given by the subject. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. A score of 0 confirms no dry eye symptoms are present, while a maximum of 100 indicates the maximum severity of symptoms experienced by subjects.|Single visit||||Score||Standard Deviation|Mean
2754094|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754095|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754096|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
2754097|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
2754098|NCT00848354|Secondary|Summary of Changes in Therapy at the Beginning of Phase 2|The investigators were allowed to alter each participant`s therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. One participant was randomized to etanercept but received SSZ in Phase 1.|||participants|||Number
2754099|NCT00848354|Secondary|Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant`s general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
2754100|NCT00848354|Secondary|Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant`s general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2754101|NCT00848354|Secondary|Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24|mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 24|Radiographic intent-to-treat (xITT) population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2754122|NCT00848198|Secondary|Referent Values for Meibomian Gland Grading|Meibomian gland dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A score of 0 indicates full integrity of these glands while the maximum of 27, is used for severe damage.|Single visit||||Grade||Standard Deviation|Mean
2754202|NCT00847665|Primary|Incidence of Pressure Ulcer (PU) Grade ≥ II|Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer|Intensive Care Unit (ICU) length of stay (days)|Intention to treat|||participants|||Number
2754102|NCT00848354|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||Units on a scale||Standard Error|Least Squares Mean
2754103|NCT00848354|Secondary|Change From Baseline in HAQ Score at Week 24|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||Units on a scale||Standard Error|Least Squares Mean
2754104|NCT00848354|Primary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. Last Observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
2754105|NCT00848250|Secondary|Postoperative Renal Function|Acute kidney injury occurring|Baseline (prior to surgery) to postoperative day 1||||Percentage of subject with AKI|||Number
2754106|NCT00848250|Secondary|Postoperative Bleeding|Chest tube output at 4 and 24 hours after completion of surgery|24 hours||||mL/kg||Standard Error|Mean
2754107|NCT00848250|Secondary|(MAP) Mean Arterial Blood Pressure||Baseline (prior to surgery) to postoperative day 1||||mmHg||Standard Error|Mean
2754108|NCT00848250|Secondary|IL-8 (Interleukin-8)||Baseline (pre-surgery) to postoperative day 1||||pg/mL||Standard Error|Mean
2754109|NCT00848250|Secondary|IL-6 (Interleukin-6)||Baseline (pre-surgery) to postoperative day 1||||pg/ml||Standard Error|Mean
2754110|NCT00848250|Primary|t-PA (Tissue-type Plasminogen Activator) Antigen||Baseline (prior to surgery) to postoperative day 1||||ng/ml||Standard Error|Mean
2754111|NCT00848250|Primary|(PAI-1) Plasminogen Activator Inhibitor -1 Antigen||Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1||||ng/ml||Standard Error|Mean
2754112|NCT00848237|Primary|Adverse Event Incidence|Adverse and Serious Adverse event with Definite device relationship|12 month||||participants|||Number
2754113|NCT00848237|Primary|Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month|Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).|12 month|943 subjects completed both baseline and follow up quality of life life survey|||units on a scale||Standard Deviation|Mean
2754114|NCT00848237|Primary|Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up|Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface|1 year||||percentage of patients with SSIM|||Number
2754115|NCT00848237|Primary|Histological Clearance Rate for Dysplasia (CE-D)|percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis|||percentage of participants|||Number
2754116|NCT00848237|Primary|Histological Clearance Rate for Intestinal Metaplasia (CE-IM)|Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA|||percentage of participants|||Number
2754117|NCT00848237|Primary|Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up|% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.|1 year|4011 subjects provided the answers|||percentage of participants|||Number
2754118|NCT00848211|Primary|CD4+ T-cell Count|Change in CD4+ T-cell count from baseline|baseline and 20 weeks||||cells/mm3||Standard Error|Log Mean
2754119|NCT00848211|Secondary|Determination of Anti-Tat Antibodies|Determination of change in anti-Tat antibody level|baseline and 16 weeks||||ng/mL||Full Range|Median
2754120|NCT00848211|Primary|HIV Viral Load|Change in HIV viral load from baseline|baseline and 20 weeks||||HIV RNA copies/mL||Standard Error|Log Mean
2754447|NCT00845832|Secondary|Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)|The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754123|NCT00848198|Secondary|Referent Values for Conjunctival Staining|Conjunctival staining is used to identify and evaluate dead or injured conjunctival cells. Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. A score of 0 indicates no damage of conjunctival cells, while the maximum for the most severe damage is 12.|Single visit||||Grade||Standard Deviation|Mean
2754124|NCT00848198|Secondary|Referent Values for Corneal Staining|Corneal Staining is used to identify and evaluate ocular surface and corneal damages. It was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. A score of 0 indicates no damage of ocular surface/cornea, while the maximum for the most severe damage is 15.|Single visit||||Grade||Standard Deviation|Mean
2754125|NCT00848198|Secondary|Referent Values for Tear Film Breakup Time||Single visit||||seconds||Standard Deviation|Mean
2754126|NCT00848198|Secondary|Referent Values for Schirmer Test||Single visit||||mm||Standard Deviation|Mean
2754127|NCT00848198|Secondary|Referent Values for Tear Osmolarity||Single visit||||mOsm/L||Standard Deviation|Mean
2754128|NCT00848198|Primary|Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
2754129|NCT00848198|Primary|Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27|Meibomian dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A cutoff threshold of grade 5/27 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
2754130|NCT00848198|Primary|Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12|Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
2754131|NCT00848198|Primary|Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15|Corneal Staining was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
2754132|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds|Tear film breakup time was measured by instilling 5μL of a 2% sodium fluoresceine solution and calculating the average of three consecutive breakup times, manually determined with a stopwatch. The cutoff of <5 seconds was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, Meibomiann secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
2754145|NCT00848120|Secondary|HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24|HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2754133|NCT00848198|Primary|Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm|"A 5-minute Schirmer test was performed with sterile strips without anesthetic (Tear Flo). The cutoff threshold of <7mm was used to differentiating normal from mild subjects.~The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit||||participants|||Number
2754134|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L|"Tear osmolarity was measured with a laboratory-on-a-chip, to simultaneously collect and analyze the electrical impedance of a 50 nL tear sample from the interior lateral meniscus (TearLab Osmolarity System). A cutoff threshold of more than 308 mOsm/L was used for differentiating normal from mild to moderate subjects.~The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit||||participants|||Number
2754135|NCT00848185|Primary|VEGF Protein and mRNA Levels|VEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG|1 year||||pg/ml||Standard Deviation|Mean
2754136|NCT00848172|Secondary|PK: AUC After OA|Area under the curve of PA plasma levels after administration|5 to 300 min post dose||||hr*ng/ml||Standard Deviation|Mean
2754137|NCT00848172|Secondary|TMax Octanoic Acid|Time to plasma peak OA|between 5 and 300 min post dose||||min||Standard Deviation|Mean
2754138|NCT00848172|Secondary|Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo|As described at the section for the primary outcome, normalized accelerometric tremor accelerometry was measured at other time-points to describe a time-course of effect. This stated secondary outcome compared normalized (baseline = 1) accelerometric at the last time-point 300 min post dose after OA vs Placebo. Ratios of tremor power at 300 min divided by tremor power at baseline used for outcome measure calculation.|300 min post dose||||ratio||Inter-Quartile Range|Median
2754139|NCT00848172|Primary|Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition|Postural tremor was measured using accelerometry with a motion sensor (accelerometer) placed at the dorsum of each hand, and tremor recorded simultaneously with surface-electromyography of wrist flexors and extensors for 2 minutes at each time-point. The recording was repeated with 1 lbs weight added to each wrist, which was described to record the central tremor component. The primary outcome measure was defined as tremor power of the central tremor component (after the addition of weight) 80 minutes after administration, measured at the dominant hand, normalized to baseline (baseline = 1), and comparing octanoic acid vs. placebo. Ratio of tremor power at 80 min divided by tremor power at baseline used for outcome measure calculation.|80 min after administration of the study drug on day 1 and 2 of Visit 2|2 patients were excluded from primary outcome measure analysis because of one subject was withdrawn prior to drug administration due to an SAE, and one subject did not exhibit a central tremor component (primary measure), on the day of administration.|||ratio||Inter-Quartile Range|Median
2754140|NCT00848120|Secondary|Time to Onset of ACR20/50/70 Response|Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||weeks||Inter-Quartile Range|Median
2754141|NCT00848120|Secondary|Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity.|Week 24|ITT Population|||percentage of participants|||Number
2754142|NCT00848120|Secondary|Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission.|Week 24|ITT Population|||percentage of participants|||Number
2754143|NCT00848120|Secondary|Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2754144|NCT00848120|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2754480|NCT00845663|Primary|Maximum Plasma Concentration (Cmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||microgram/mL||Full Range|Geometric Mean
2754148|NCT00848120|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24|ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.|Week 24|ITT population|||percentage of participants|||Number
2754149|NCT00848107|Primary|Formation of New Ulcers|The number and percentage of subjects who developed new ulcers during the study were summarized.|18 months (or last study visit)|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||participants|||Number
2754150|NCT00848107|Primary|Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|"The total ulcer number includes all ulcers designated as active, indeterminate, or new for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment."|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||number of ulcers||Standard Deviation|Mean
2754151|NCT00848107|Secondary|Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment|The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis. Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible). The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value. The mean change from study entry in CHFS scores at each scheduled assessment are summarized.|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||units on a scale||Standard Deviation|Mean
2754152|NCT00848107|Primary|Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|"Net ulcer burden at any given assessment was defined as the number of new or active ulcers at that assessment, plus the number of indeterminate ulcers at that assessment that had previously been classified as either active or new at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment."|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed using data obtained at each visit, if available, from all subjects enrolled in this study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||ulcers||Standard Deviation|Mean
2754153|NCT00848107|Secondary|Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment|The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud's Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters. The questions are divided into eight component domains: Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain. Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation). The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||units on a scale||Standard Deviation|Mean
2754154|NCT00848081|Secondary|Uroflowmetry (Qmax) Change From Baseline|Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).|Baseline, 12 Weeks|All randomized subjects with non-missing data.|||milliliters per second||Standard Deviation|Mean
2754155|NCT00848081|Secondary|Postvoid Residual Volume (PVR) Change From Baseline|Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.|Baseline, 12 Weeks|All randomized subjects who had non-missing baseline and endpoint data.|||milliliters||Standard Deviation|Mean
2754156|NCT00848081|Secondary|International Prostate Symptom Score (IPSS) Change From Baseline|Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.|||units on a scale||Standard Deviation|Mean
2754212|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754157|NCT00848081|Secondary|Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit|A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.|Baseline through 12 Weeks|All randomized subjects in the analysis population with non-missing data.|||Participants|||Number
2754158|NCT00848081|Primary|Number of Men With Treatment-emergent Dizziness|The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.|Baseline through 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.|||Participants|||Number
2754159|NCT00848042|Secondary|Response in Targeted Tumors.||6 months|Data was not collected/analyzed||||||
2754160|NCT00848042|Primary|Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration|Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion|up to 6 months|per protocol|||participants|||Number
2754161|NCT00848016|Secondary|Progression-free Survival|The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.|From registration to progression or death, whichever occurs first, up to 2 years.||||months||95% Confidence Interval|Number
2754162|NCT00848016|Secondary|Overall Survival|The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to date of last follow-up or death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2754163|NCT00848016|Primary|The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria|"In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2754164|NCT00847938|Primary|Mesure of the Train-of-four (TOF)|train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation.|from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour||||minute||Full Range|Median
2754165|NCT00847912|Primary|Hazard Ratio for Surgically Treated KC||date of randomization to last visit before end of study follow up (6/30/2013), assessed up to four years||||participants|||Number
2754166|NCT00847912|Primary|The Time to Diagnosis of the First Keratinocyte Carcinoma (KC) on the Face or Ears for Which Surgery is Performed|Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.|From randomization to last visit prior to end of study date (6/30/2013), assessed up to four years||||years||95% Confidence Interval|Median
2754167|NCT00847886|Secondary|Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15|Baseline was defined as pre-dose on Day 1.|Day 15||||Percent||Standard Deviation|Mean
2754168|NCT00847886|Secondary|Half-life of LX3305 in Plasma in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.|||hours||Standard Deviation|Mean
2754169|NCT00847886|Secondary|Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.|||hours||Full Range|Median
2754170|NCT00847886|Secondary|Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.|||ng/mL||Standard Deviation|Mean
2754171|NCT00847886|Primary|Amount of 7-OH-MTX Excreted in the Urine||Day 15||||µg||Standard Deviation|Mean
2754172|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of 7-OH-MTX||Day 15||||hours||Full Range|Median
2754173|NCT00847886|Primary|7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration|7-OH-MTX is the primary metabolite of methotrexate.|Day 15||||ng/mL||Standard Deviation|Mean
2754174|NCT00847886|Primary|Amount of Methotrexate Excreted in the Urine||Day 15||||µg||Standard Deviation|Mean
2754175|NCT00847886|Primary|Half-life of Methotrexate in Plasma||Day 15||||hours||Standard Deviation|Mean
2754176|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of Methotrexate||Day 15||||hours||Full Range|Median
2754177|NCT00847886|Primary|Methotrexate Maximum Plasma Concentration||Day 15||||ng/mL||Standard Deviation|Mean
2754178|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754179|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754180|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754181|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754182|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754183|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754184|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754185|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754186|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754224|NCT00847613|Other Pre-specified|Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.||||||
2754481|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||microgram*day/mL||Full Range|Geometric Mean
2754187|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754188|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754189|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754190|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2754191|NCT00847808|Primary|Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.|Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.|Week 3 through Week 6|Values are from the Full Analysis Set.|||percent of participants|||Number
2754192|NCT00847730|Primary|Ease of Use Assessment|Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.|48-72 hours (+6 hours) time period|ITT (Intent to Treat) population.|||Participants|||Count of Participants
2754193|NCT00847704|Secondary|Active Motion Test|Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)||||Seconds||Standard Deviation|Mean
2754194|NCT00847704|Secondary|Strength Test|Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)||||Newton meters||Standard Deviation|Mean
2754195|NCT00847704|Secondary|Spasticity (Modified Ashworth) Scale|Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||units on a scale||Standard Deviation|Mean
2754196|NCT00847704|Secondary|Stroke Impact Scale|"The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:~Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100.~Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning."|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||units on a scale||Standard Deviation|Mean
2754197|NCT00847704|Secondary|Timed 10-Meter Walk|Gait Assessment - Time|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||seconds||Standard Deviation|Mean
2754198|NCT00847704|Primary|Fugl-Meyer Assessment of the Lower Extremity|Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||units on a scale||Standard Deviation|Mean
2754199|NCT00847665|Secondary|Length of Mechanical Ventilation (MV)|Time from initiation to withdrawal of mechanical ventilation. Days|ICU length of stay||||days||Inter-Quartile Range|Median
2754203|NCT00847626|Secondary|Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||percentage of participants|||Number
2754204|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the average of the 3 serial trough sitting clinic diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||percentage of participants|||Number
2754205|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754206|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the average of the 3 serial trough sitting clinic systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||percentage of participants|||Number
2754207|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754208|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754209|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754210|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754211|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754482|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||microgram *day/mL||Full Range|Geometric Mean
2754213|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754214|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754215|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754216|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754217|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)|The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754218|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)|The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754219|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754220|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2754221|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12, 18, 24|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754222|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754223|NCT00847613|Other Pre-specified|Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.||||||
2754225|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 9, 12, 15, 18, 21, 24|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.|||mmHg||Standard Deviation|Mean
2754226|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 1, 3, 6|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2754227|NCT00847613|Other Pre-specified|Association Between Genomic and Metabonomic Variation||Month 24||2013-02-28|02/2013||||
2754228|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754229|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754230|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754231|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754232|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754233|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754234|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754235|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754236|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754237|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754238|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754239|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754240|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754241|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||hours per day||Standard Deviation|Mean
2754658|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2754242|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||hours per day||Standard Deviation|Mean
2754243|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||days||Standard Deviation|Mean
2754244|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||days||Standard Deviation|Mean
2754245|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||events||Standard Deviation|Mean
2754246|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||events||Standard Deviation|Mean
2754247|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754248|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family, friends or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754249|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754498|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
2754250|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754251|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754252|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754253|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754254|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754255|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.|||participants|||Number
2754256|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754294|NCT00847535|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.~All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment|During the study, 66 patients underwent a total of 78 biopsies.|||participants|||Number
2754257|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||participants|||Number
2754258|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754259|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754260|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754261|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||mm||Standard Deviation|Mean
2754262|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
2754263|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||mm||Standard Deviation|Mean
2754264|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
2754265|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||mm||Standard Deviation|Mean
2754266|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
2754295|NCT00847522|Secondary|Safety Evaluation of Intradermal Fluorescein Injections.|Number of participants that experienced an adverse event|1 month||||Participants|||Count of Participants
2754267|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754268|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754269|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Month 12 and 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754270|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Baseline|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2754271|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).||||||
2754272|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).||||||
2754273|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754274|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754275|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
2754276|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2754277|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754278|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754279|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754280|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754281|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
2754282|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754283|NCT00847613|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
2754296|NCT00847522|Primary|Percentage of Agreement Between the Detection of SLNs|There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.|2 days|Total number of patients with at least one SLN was 89|||percentage complete agreement|||Number
2754284|NCT00847613|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2754285|NCT00847613|Primary|Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Baseline, Month 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2754286|NCT00847613|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.|||percentage of participants|||Number
2754287|NCT00847587|Secondary|Crematocrit of Human Milk|Determination of creamatocrit is a simple method for estimating the fat & energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, & vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis.|6 weeks postpartum|Both intent-to-treat and per-protocol analyses were performed. Per-protocol analysis is presented to demonstrate the more conservative analysis for the primary outcomes in a noninferiority study.|||Percent creamatocrit||Standard Deviation|Mean
2754288|NCT00847587|Primary|Time to Lactogenesis Stage II|"The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby's mouth, or gulping by the baby.  If the response was positive, subjects were then asked, When did your milk come in? and the response recorded to the nearest hour."|5 days postpartum||||hours||Standard Deviation|Mean
2754289|NCT00847561|Primary|Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)|"The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues.~This interview will be administered by a trained staff member and will utilize information from both parents and children.~This interview will be used to determine the presence or absence of an anxiety disorder for children in this study.~."|12 months post-treatment||||participants with anxiety diagnosis|||Number
2754290|NCT00847535|Primary|Number of Participants That Experienced AMDC Product-related Adverse Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.~No adverse events reported during the study were adjudicated as AMDC product-related."|12 months||||participants|||Number
2754291|NCT00847535|Primary|Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.~All injection procedure-related events self-resolved or were easily treated."|30 days||||Number of events|||Number
2754292|NCT00847535|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.~All injection procedure-related events self-resolved or were easily treated."|30 days|Sixty-four patients underwent intrasphincteric injection of AMDC.|||participants|||Number
2754293|NCT00847535|Primary|Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.~All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment||||Number of events|||Number
2754659|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2754301|NCT00847301|Secondary|Volume of Wound Drainage (Post-operative)|Volume of Wound Drainage after surgery|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||ml||Standard Deviation|Mean
2754302|NCT00847301|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings|Percentage of Patients With Major Extra-surgical Site Bleedings|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of Participants||95% Confidence Interval|Number
2754303|NCT00847301|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of Participants||95% Confidence Interval|Number
2754304|NCT00847301|Primary|Percentage of Patients With Major Bleeding Events (MBE)|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of participants||95% Confidence Interval|Number
2754305|NCT00847301|Secondary|Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality|Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of participants||95% Confidence Interval|Number
2754306|NCT00847288|Secondary|Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year||||months||95% Confidence Interval|Median
2754307|NCT00847288|Secondary|Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews|The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.|1 year||||percentage of visits with action|Participants|95% Confidence Interval|Mean
2754308|NCT00847288|Secondary|Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm|"There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.~Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score."|1 year|"For each component, the subject needs to have baseline and 6 (or 12) month measurements to calculate the changes. Subjects included for the each component are as following:~Maintenance (or Confidence): 720 and 675 for monthly and quarterly arms at 6 mo, respectively, 640 and 588 at 12 mo. Management, 166 and 141 at 6 mo, 166 and 104 at 12 mo."|||units on a scale||Standard Deviation|Mean
2754309|NCT00847288|Primary|Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year|All patients enrolled in the study, who have eligible study device, signed inform consent, signed HIPAA, and have at least one OptiVol threshold crossing post the start date, were included in this analysis.|||months||95% Confidence Interval|Median
2754310|NCT00847210|Primary|Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|After 7 days of dosing.|All participants who had Vz/F estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.|||L||Standard Deviation|Mean
2754311|NCT00847210|Primary|Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.|After 7 days of dosing.|All participants who had λz estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.|||1/hr||Standard Deviation|Mean
2754312|NCT00847210|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter.|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.|After 7 days of dosing.|All participants who had CL/F estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.|||liter/hr||Standard Deviation|Mean
2754313|NCT00847210|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|After 7 days of dosing.|All participants who had T1/2 estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. No statistical tests were performed.|||hours||Standard Deviation|Mean
2754314|NCT00847210|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.|AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).|After 7 days of dosing.|All participants who had AUC(0-24) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||ng*hr/mL/mg||Standard Deviation|Mean
2754315|NCT00847210|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.|Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|After 7 days of dosing.|All participants who had AUC(0-tlqc) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||ng*hr/mL/mg||Standard Deviation|Mean
2754316|NCT00847210|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|After 7 days of dosing.|All participants who had Cmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||ng/mL||Standard Deviation|Mean
2754317|NCT00847210|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.|After 7 days of dosing.|All participants who had Tmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the pharmacokinetic (PK) analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||hours||Standard Deviation|Mean
2754318|NCT00847197|Secondary|Percent Change From Baseline in Triglycerides (mg/dL)||Baseline and 4 Weeks|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.|||Percent Change||Standard Deviation|Mean
2754319|NCT00847197|Primary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.|||Percent Change||Standard Deviation|Mean
2754320|NCT00847197|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.|||Percent Change||Standard Deviation|Mean
2754321|NCT00847171|Secondary|Clinical Benefit as Assessed by Number of Participants With Progression-free Survival|Number of participants without evidence of disease progression.|4 years|Only 13/20 participants had early stage disease, and 7/20 participants had a history of metastatic disease at the start of the study. All participants were assigned to the same treatment group.|||Participants|||Count of Participants
2754322|NCT00847171|Primary|Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides||4 years||||Participants|||Count of Participants
2754323|NCT00847171|Primary|Safety as Assessed by Number of Participants Experiencing Toxicity|Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy.|4 years||||Participants|||Count of Participants
2754324|NCT00847145|Secondary|Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 8 to day 28 after MMRV vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
2754401|NCT00846495|Secondary|Number of Headache Days Each Month Following Initiation of Treatment With Study Medication|Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication|2 Months|Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.|||Headache Days|Participants|Standard Deviation|Mean
2754325|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 1 to day 7 after MMRV vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
2754326|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).|From day 1 to day 7 after each rMenB+MV NZ vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
2754327|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.|From day 1 to day 7 after each rMenB+OMV NZ vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
2754328|NCT00847145|Secondary|Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.|||Percentages of Subjects||95% Confidence Interval|Number
2754329|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers|The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.|One month after the first dose and one month after the second dose.|The analysis was done on the SBA PP Catch-up population.|||IU/mL||95% Confidence Interval|Geometric Mean
2754330|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.|||IU/mL||95% Confidence Interval|Geometric Mean
2754331|NCT00847145|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.|One month after the second dose.||||Percentages of Subjects||95% Confidence Interval|Number
2754332|NCT00847145|Secondary|SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.|One month after the second dose.|The analysis was done on the SBA PP Catch-up population.|||Titers||95% Confidence Interval|Geometric Mean
2754333|NCT00847145|Secondary|Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)|The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.|one month after booster (fourth) dose vaccination and pre-fourth dose vaccination|This analysis was done on the PP population.|||Titers||95% Confidence Interval|Geometric Mean
2754334|NCT00847145|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)|Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|One month post vaccination and pe-booster (fourth) dose vaccination|The analysis was done on PP population.|||Percentages of subjects||95% Confidence Interval|Number
2754335|NCT00847145|Secondary|Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)|The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|one month after third vaccination and pre dose fourth (booster) vaccination||||Titers||95% Confidence Interval|Geometric Mean
2754336|NCT00847145|Secondary|The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after booster (fourth) vaccination.|This analysis was done on PP population.|||Titers||95% Confidence Interval|Geometric Mean
2754337|NCT00847145|Secondary|Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination|"Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.~The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection."|one month after booster (fourth) dose|This analysis was done on Per Protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2754338|NCT00847145|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.|one month after the booster (fourth) dose|The analysis was done on Per Protocol (PP) population – subjects who received all doses of vaccine in parent & present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent & visit 1 blood draw in present study, had no major protocol violation|||Percentages of subjects||95% Confidence Interval|Number
2754339|NCT00847132|Secondary|Change in Depression Symptoms From Baseline to 6 Months|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 6 weeks, 12 weeks, 6 months||||units on a scale||95% Confidence Interval|Mean
2754340|NCT00847132|Primary|Rates of Adequate Depression Treatment at Discharge|"Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).~Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment||||percentage of participants|||Number
2754341|NCT00847015|Secondary|The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.|The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.|2 years||||months||95% Confidence Interval|Median
2754342|NCT00847015|Secondary|The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years||||percentage of participants||95% Confidence Interval|Number
2754343|NCT00847015|Primary|The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years||||percentage of participants||95% Confidence Interval|Number
2754344|NCT00847002|Secondary|Reduction in Leg Volume||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.||||||
2754345|NCT00847002|Primary|Wound Healing||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.||||||
2754346|NCT00846885|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2754347|NCT00846885|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2754348|NCT00846885|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2754349|NCT00846846|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.|Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.|3 years|Main secondary endpoint results for the ITT population are similar to the primary endpoint analysis, a total of nine hundred and forty seven (947) ITT patients had sufficient follow-up or an event to be included in the main secondary endpoint analyses.|||percentage of participants||95% Confidence Interval|Number
2754350|NCT00846846|Primary|To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation|The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.|3 years|Of the one thousand and eighteen (1018) ITT patients, a total of nine hundred and forty seven (947) patients were included in the primary endpoint analysis. These patients had at least 1050 days of follow-up or had experienced stent thrombosis prior to 1080 days.|||percentage of participants||95% Confidence Interval|Number
2754351|NCT00846807|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||Percentage of participants||95% Confidence Interval|Number
2754352|NCT00846807|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||ml||Standard Deviation|Mean
2754660|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2754354|NCT00846807|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||Percentage of participants||95% Confidence Interval|Number
2754355|NCT00846807|Primary|Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated Set (TS) comprises all patients who completed the surgery and received at least 1 dose of dabigatran etexilate.|||Percentage of participants||95% Confidence Interval|Number
2754356|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours|Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.~This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."|||percent||Geometric Coefficient of Variation|Geometric Mean
2754357|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours|"Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.~Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||percent||Geometric Coefficient of Variation|Geometric Mean
2754358|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours|Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.~This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."|||ng||Geometric Coefficient of Variation|Geometric Mean
2754359|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours|"Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.~Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||ng||Geometric Coefficient of Variation|Geometric Mean
2754360|NCT00846768|Secondary|Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State|Steady state concentration of the analyte in plasma measured at 0.167 hours post dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. In the Olo 2 mcg Bid Arm, there were only 14 patients with values within the validated concentration range."|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2754361|NCT00846768|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|3 weeks|Treated set.|||percentage of participants|||Number
2754362|NCT00846768|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754363|NCT00846768|Secondary|Peak FVC (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2755356|NCT00839917|Other Pre-specified|Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2754364|NCT00846768|Secondary|FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754365|NCT00846768|Secondary|FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754366|NCT00846768|Secondary|FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754367|NCT00846768|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754368|NCT00846768|Secondary|Peak FEV1 (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754369|NCT00846768|Secondary|FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754370|NCT00846768|Primary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754371|NCT00846768|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
2754372|NCT00846742|Secondary|Event-free Survival Distributions of Favorable Risk Patients Treated With Stanford V Chemotherapy Alone and Patients Treated With Stanford V Chemotherapy Plus Low Dose Tailored-field Radiation|Event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation will be estimated by the Kaplan-Meier method.|median 2 years post therapy|||||||
2754373|NCT00846742|Secondary|Comparison of Event-free Survival Distributions Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy|Log-rank tests used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens.|median 2 years post therapy|||||||
2754374|NCT00846742|Secondary|Comparison of Event-free and Overall Survival Distributions, Cumulative Incidence of Local Failure, and Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99|Log-rank tests used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens.|median 2 years post therapy|||||||
2754375|NCT00846742|Secondary|Acute Infectious Toxicities|Description of acute infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute infectious toxicities were summarized descriptively.|6 months||||Adverse events|||Number
2754376|NCT00846742|Secondary|Acute Hematologic Toxicities|Description of acute hematologic toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute hematologic toxicities were summarized descriptively.|6 months||||adverse events|||Number
2754377|NCT00846742|Secondary|Treatment Failure Patterns for Children Treated With Tailored-field Radiation|Descriptive statistics related to local/distant failure will be produced. The cumulative incidence of local failure will be estimated and effects of prognostic factors will be examined. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Relapse rate within the radiation fields will be estimated and confidence interval will also be calculated.|median 2 years post therapy|||||||
2754378|NCT00846742|Secondary|Disease Failure Rate Within Radiation Fields|Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).|median 2 year post therapy|||||||
2754379|NCT00846742|Primary|Complete Response Rate Estimate|To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks VAMP (NCT number: NCT00145600) .Complete response definition: Disappearance of all measurable or evaluable disease, signs, symptoms and biochemical changes related to the tumor. Biopsy confirmation is not mandatory. Residual PET-negative CT scan abnormalities representing > 75% reduction (as measured by the product of 2 perpendicular diameters of lesions by CT or MR imaging) in the original tumor volume will be considered scar tissue without active tumor.|8 weeks||||percentage of participants||95% Confidence Interval|Number
2754380|NCT00846651|Secondary|Incidence of Maternal Nausea and Vomiting||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||percentage of participants|||Number
2754381|NCT00846651|Secondary|APGAR Scores|The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).|Apgar scores were assessed at 1 amd 5 min after delivery of the baby||||units on a scale||Full Range|Median
2754382|NCT00846651|Secondary|Fetal Cord Blood pH||delivery of the baby|Physician policy changes resulted in blood gas values not being ordered and thus data was not available for the outcome measure.||||||
2754383|NCT00846651|Secondary|Incidence of Maternal Bradycardia||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||percentage of participants|||Number
2754384|NCT00846651|Secondary|Dosage of Phenylephrine Used||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||mcg of phenylephrine||Standard Deviation|Mean
2754385|NCT00846651|Primary|Incidence of Maternal Hypotension||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||percentage of participants|||Number
2754386|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2754387|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2754402|NCT00846495|Primary|Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine|Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine|Treatment Month 2||||Headache Days||Standard Deviation|Mean
2754388|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2754389|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2754390|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2754391|NCT00846586|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2754392|NCT00846573|Primary|Hyperpolarized Helium-3 MR Images|We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.|15 second breath-hold|We recruited participants of each category until we were satisfied with the images we obtained.|||participants|||Number
2754393|NCT00846547|Primary|Irritability Subscale of the Aberrant Behavior Checklist, Community Version|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|At 8 weeks during the treatment period||||Points on a scale||Standard Error|Least Squares Mean
2754394|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||After 6 Weeks (post treatment)|The number of participants who completed the study were analyzed|||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
2754395|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||At baseline (before treatment)|The number of participants who completed the study were analyzed|||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
2754396|NCT00846495|Secondary|Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine|Average cost of study medication taken by each subject. Measured in dollars.|Treatment Months 1 and 2||||Dollars (US)||Standard Deviation|Mean
2754397|NCT00846495|Secondary|Adverse Events Associated With Study Medications|Includes Adverse Events at or above 5% frequency per group.|Treatment Months 1 and 2||||Adverse Events|Participants||Number
2754398|NCT00846495|Secondary|Participant Satisfaction With Study Medications|"Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.~Participants completed the PPMQ 24 hours following each first dose of frovatriptan."|Treatment Month 2||||Score on a Scale||Standard Deviation|Mean
2754399|NCT00846495|Secondary|Quality of Life in Subjects Utilizing Each Treatment Paradigm|Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.|Randomization, End of Treatment Month 1, End of Treatment Month 2||||Score on a Scale||Standard Deviation|Mean
2754400|NCT00846495|Secondary|Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm|Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2|2 Months||||Participants|||Number
2754445|NCT00845832|Secondary|Change From Baseline to Week 48 in ESR|ESR is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754403|NCT00846495|Primary|Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate|Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2|Treatment Month 2|Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.|||Migraine attacks|Participants|Standard Deviation|Mean
2754404|NCT00846391|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values.~Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored."|Baseline and Week 4|The analysis population included all patients with a baseline value and Week 4 value for this outcome.|||mg/dL||Standard Deviation|Mean
2754405|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve both a clinic diastolic blood pressure response, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) or <130/80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||percentage of participants|||Number
2754406|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic diastolic blood pressure response, defined as defined as <90 mm Hg for participants without diabetes or CKD or <80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||percentage of participants|||Number
2754407|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic systolic blood pressure response, defined as <140 mm Hg for participants without diabetes or CKD or <130 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||percentage of participants|||Number
2754408|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754409|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean Systolic Blood Pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754410|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the nighttime, while asleep (12am to 6am) mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754411|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the nighttime, while asleep (12am to 6am) mean systolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754412|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean diastolic blood pressure measured at Week 4 and Week 8relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754413|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean systolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754414|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 24-hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. . Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average of measurements collected over the subsequent 24 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754415|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-hour mean systolic blood pressure at week4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754416|NCT00846365|Secondary|Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754417|NCT00846365|Secondary|Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
2754418|NCT00846365|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 4 and week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Deviation|Least Squares Mean
2754419|NCT00846365|Secondary|Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 4 relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 4.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Deviation|Least Squares Mean
2754420|NCT00846365|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Deviation|Least Squares Mean
2754421|NCT00846287|Secondary|Change in FEV1|Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.|2 hours|As per protocol|||Litres||Standard Deviation|Median
2754422|NCT00846287|Primary|Change in Total Ventilation Volume|"Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described:~The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation."|2 hours|Analysis per protocol.|||Litres||Standard Deviation|Mean
2754423|NCT00846066|Primary|Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months|The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%|At baseline and 6 months|Analysis per protocol. Subjects dropped from analysis because charts not available within the time frame of the study and incomplete data.|||Percent change||Standard Deviation|Mean
2754424|NCT00846066|Primary|Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months|"Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the agree and strongly agree responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months||||Percent change||Standard Deviation|Mean
2754425|NCT00846066|Primary|Percent Change From Baseline in Confidence at 4 Months|"Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of very confident was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months|Only completed paired (pre/post intervention) surveys were analyzed|||Percent change.||Standard Deviation|Mean
2754426|NCT00846066|Primary|Mean Percentage of Correct Skills|Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups|3 months after Hands-on Training (HOT)||||Percentage of correct skills||Standard Deviation|Mean
2754427|NCT00846053|Secondary|Sputum Neutrophil Elastase (NE) Concentration|Using established techniques, functional activity of neutrophil elastase in sputum sols were measured using methoxy-succinyl-ala-ala-pro-val-nitroanilide (Elastin Products, Owensville, MO), specific peptide chromogenic substrates of the neutrophil protease|Sample collected within 2-hours of PET scan|Not every participant in the stable lung function group could produce sputum.|||microgram (mcg) NE /mcg protein||Standard Deviation|Mean
2754428|NCT00846053|Primary|Kinetic Influx Constant (Ki)|The whole lung kinetic influx constant (Ki) is the primary outcome measure that is derived from the time-activity curves, which are generated from regions of interest placed over the whole lungs. Therefore, a single time-activity curves from each scan is used to derive the Ki.|At the time of FDG scan, 1 to 2 hours|CF adolescents and young adults, ages 12 to 21 years, who did not have CFRD.|||mL/min/mL||Standard Deviation|Mean
2754429|NCT00846027|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.|||Months||95% Confidence Interval|Median
2754430|NCT00846027|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.|||Months||95% Confidence Interval|Median
2754431|NCT00846027|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2754432|NCT00846027|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.|||Months||95% Confidence Interval|Median
2754433|NCT00845975|Secondary|Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion|The Trait portion of the State-Trait Anxiety Inventory (STAI-T) evaluates an individual's tendency to get anxious and how they respond to stress. The STAI-T has 20 items rated on a 4-point frequency of occurrence scale of 1=Almost Never, 2=Sometimes, 3=Moderately So, and 4=Very Much So. The individual scores are summed to get the total STAI-T score. The higher the total score, the more anxious the individual, and the lower the total score, the less anxious the individual. Change in STAI-T score is calculated as the STAI-T score at 4 weeks after baseline evaluation minus the STAI-T score at baseline. A positive (+) change in STAI-T score indicates that the anxiety has worsened. A negative (-) change in STAI-T score indicates the depression has lessened. A change in STAI-T score of -8 or greater indicates a meaningful lessening of anxiety and is positive for study success.|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2754446|NCT00845832|Secondary|Change From Baseline to Week 48 in C-Reactive Protein (CRP)|CRP is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754434|NCT00845975|Secondary|Beck Depression Inventory-II (BDI-II)|The Beck Depression Inventory®-II (BDI®-II) is a 21-item questionnaire used to assess depression. Most items are rated on a 4-point scale from 0 to 3, and a few items are rated on a 7-point scale. Individual item scores are added to get a total score from 0 to 63. The higher the total score, the more severe the depression, and the lower the total score, the less severe the depression. Change in BDI®-II score is calculated as the BDI®-II score 4 weeks after baseline evaluation minus the BDI®-II score at baseline. A positive (+) change in BDI®-II score indicates that the depression has worsened. A negative (-) change in BDI®-II score indicates the depression has lessened. A change in BDI®-II score of -6 or greater indicates a meaningful lessening of depression and is positive for study success.|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2754435|NCT00845975|Primary|Total Score on the Tinnitus Handicap Inventory (THI).|The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual's life. Each question is responded to as 'yes' (4 points); 'sometimes' (2 points) or 'no' (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual's life. Change in total THI score is calculated as total THI score after the one week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual's everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual's life and is positive for study success.|baseline and one week||||units on a scale||Standard Deviation|Mean
2754436|NCT00845897|Secondary|Barefoot Plantar Pressure|Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm^2.|pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing||||Peak Plantar Pressure (N/cm^2) changes||Standard Deviation|Mean
2754437|NCT00845897|Primary|Plantar Flexor Muscle Strength|Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing & Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.|Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing||||Plantar Flexor Torque (Nm)||Standard Deviation|Mean
2754438|NCT00845858|Other Pre-specified|The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.~The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).~Nausea (feeling sick to your stomach as if you were going to vomit or throw up)~Early satiety (not able to finish a normal sized meal)~Bloating (feeling like you need to loosen clothes)~Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.~A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks||||units on a scale||Standard Deviation|Mean
2754439|NCT00845858|Primary|The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.~The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).~Nausea (feeling sick to your stomach as if you were going to vomit or throw up)~Early satiety (not able to finish a normal sized meal)~Bloating (feeling like you need to loosen clothes)~Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.~A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks|ITT|||units on a scale||Standard Deviation|Mean
2754440|NCT00845845|Secondary|Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.||||||
2754441|NCT00845845|Primary|Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.||||||
2754442|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant's Assessment of Pain|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754443|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant's Global Assessment of Disease Activity|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754444|NCT00845832|Secondary|Change From Baseline to Week 48 in Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754448|NCT00845832|Secondary|Change From Baseline to Week 48 in SJC and TJC|An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
2754449|NCT00845832|Secondary|Simplified Disease Activity Index (SDAI) Scores|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48|Data were not collected because the study was terminated early.||||||
2754450|NCT00845832|Secondary|Clinical Disease Activity Index Scores|"The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10~Where:~SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant's global assessment of disease activity; EGA = evaluator's (physician's) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity >22; moderate disease activity >10 and ≤22; LDA >2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2754451|NCT00845832|Secondary|Change From Baseline in DAS28-ESR|"The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).~DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 * √TJC)+(0.28 * √SJC)+(0.70 * ln(ESR))+(0.014 * GH).~No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS."|Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; number (n) = number of participants analyzed at the specified visit.|||units on a scale||Standard Deviation|Mean
2754452|NCT00845832|Secondary|Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or DAS28-ESR >5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 16|ITT Population; No imputation used for TJC, SJC, ESR, and PtGA. EULAR response was set to missing when the DAS28 score was missing.|||percentage of participants|||Number
2754453|NCT00845832|Secondary|Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR|The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (<) 2.6|Week 16|ITT Population; LOCF used for TJC, ESR, and PtGA. If the DAS28-ESR value was missing then remission or LDA was missing.|||percentage of participants|||Number
2754454|NCT00845832|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)|"The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC [28 joints]), Swollen Joint Count (SJC [28 joints]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2.~DAS28-ESR equals (=) (0.56 times (*) (square root)√ TJC plus (+) (0.28 * √ SJC + (0.70 * ln(ESR))+(0.014 * (Global Health) GH)~Where:~TJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant's global assessment of disease activity ln = natural log"|Week 16|Intent-to-Treat (ITT) Population: all randomized participants who received any part of an infusion of study medication. Last observation carried forward (LOCF) used for TJC and SJC, ESR and PtGA. If DAS28-ESR value was missing LDA was missing.|||percentage of participants|||Number
2754455|NCT00845728|Secondary|Rate of COPD Exacerbations|COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.|52 weeks|Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.|||Exacerbations per patient per year|||Number
2754483|NCT00845650|Secondary|Mean Residence Time (MRT)|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||hours||Standard Deviation|Mean
2754456|NCT00845728|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1).|The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.|12 weeks|Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.|||Liters||Standard Error|Least Squares Mean
2754457|NCT00845702|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared|1 to 7 days|The study has been prematurely terminated, and the planned analyses were not done||||||
2754458|NCT00845676|Secondary|Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype|Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR|24 weeks|||||||
2754459|NCT00845676|Secondary|Safety and Tolerability of Treatment|Number of participants with treatment-associated problems|48 weeks|||||||
2754460|NCT00845676|Primary|Sustained Virologic Response (SVR)|Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment|24 weeks||||percentage of participants|||Number
2754461|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754462|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754463|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754464|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754465|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754466|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754467|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
2754468|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 h and 24 h after injection|Intent-to-treat population|||Participants|||Number
2754469|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population|||Participants|||Number
2754470|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population|||Participants|||Number
2754471|NCT00845663|Secondary|Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection|Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).|Immediately after injection and 1 hour after injection|Intent-to-treat population|||Units on a scale||Standard Deviation|Mean
2754472|NCT00845663|Secondary|Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||Participants|||Number
2754473|NCT00845663|Secondary|Apparent Volume of Distribution (Vz/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||L||Full Range|Geometric Mean
2754474|NCT00845663|Secondary|Apparent Total Body Clearance (CL/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||mL/day||Full Range|Geometric Mean
2754475|NCT00845663|Secondary|Time Corresponding to Cmax (Tmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
2754476|NCT00845663|Secondary|Apparent Terminal Elimination Half-life (t1/2)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
2754477|NCT00845663|Secondary|Apparent Terminal Elimination Rate Constant (λz)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||1/day||Standard Deviation|Mean
2754478|NCT00845663|Secondary|Lowest Quantifiable Concentration Time (LQCT)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
2754479|NCT00845663|Secondary|Time Point Where Log-linear Elimination Phase Begins (TLIN)|TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.|After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
2754484|NCT00845650|Secondary|Elimination Half-life (t½)|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||hours||Full Range|Median
2754485|NCT00845650|Secondary|Elimination Rate Constant|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||/h||Standard Deviation|Mean
2754486|NCT00845650|Secondary|Area Under the Curve to Infinity (AUC[0-inf])|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||h*NF50||Standard Deviation|Mean
2754487|NCT00845650|Secondary|Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||h*NF50||Standard Deviation|Mean
2754488|NCT00845650|Secondary|Time of Cmax|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||hours||Standard Deviation|Mean
2754489|NCT00845650|Secondary|Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic (PK) intent-to-treat (ITT) population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||NF50 (50% neutralization factor)||Standard Deviation|Mean
2754490|NCT00845650|Primary|Number of Participants Reporting Adverse Events (AEs)|Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).|From the time of infusion through Day 90.|Safety Population: all subjects who received any infusion of AIGIV or Gamunex.|||Participants|||Count of Participants
2754491|NCT00845520|Other Pre-specified|Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better|Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.|12 months|All available eyes at 12 months. The overall number of participants for this outcome measures differs the previously stated overall number of 74 because two subjects were deceased at their 12 month post-operative follow up visit.|||percentage of eyes|||Number
2754492|NCT00845520|Secondary|Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)|Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.|6 months post operative|Participants with eyes with UCVA of 20/50 or worse UCVA prior to light treatment|||percentage of eyes|||Number
2754493|NCT00845520|Primary|Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target|Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.|6 months post-operative|ITT|||percentage of eyes|||Number
2754494|NCT00845507|Secondary|Change in Body Mass Index (BMI) From Baseline to Endpoint.|Secondary outcome measures included change in body mass index (BMI).|16 Weeks|All subjects who took at least one dose of study medication and had one post-baseline evaluation.|||Kgs/meter squared||Standard Deviation|Mean
2754495|NCT00845507|Primary|Change in Weight From Baseline to Endpoint.|Change in weight from baseline to endpoint in the intent-to-treat (ITT) population (all subjects who took at least one dose of study medication and had one post-baseline evaluation).|16 Weeks|All subjects who took at least one dose of study medication and had one post-baseline evaluation.|||Pounds||Standard Deviation|Mean
2754496|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
2754497|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
2754499|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
2754500|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
2754501|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
2754502|NCT00845429|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.|"Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.~Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2754503|NCT00845429|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.|"Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.~Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21."|Day 21 post-vaccination|Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.|||Percentage of Participants|||Number
2754504|NCT00845429|Primary|Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.|Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)|Day 21 post-vaccination|Seroprotection was assessed in the full analysis set population.|||Percentage of Participants|||Number
2754505|NCT00845429|Primary|Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.||Days 0 and 21 post-vaccination|Geometric mean titers were assessed in the full analysis set population.|||Titers||95% Confidence Interval|Geometric Mean
2754506|NCT00845195|Primary|Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
2754507|NCT00845195|Primary|Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
2754508|NCT00845195|Primary|Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
2754509|NCT00845195|Primary|Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
2754510|NCT00845182|Secondary|Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids|"Effect pioglitazone, exenatide, and pioglitazone plus exenatide on~Insulin sensitivity~Inflammatory cytokines~glucagon and free fatty acids~plasma lipids measured over a 6 month period"|6 months|Data were not collected for this analysis||||||
2754511|NCT00845182|Primary|HbA1c|change in HbA1c was measured before and after treatment in three groups|baseline and 6 months|There was a greater improvement in HbA1c from baseline after combined treatment with Pioglitazone and Exenatide when compared with either therapy alone.|||percent point decrease from baseline||Standard Deviation|Mean
2754512|NCT00845182|Primary|Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight|Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function|baseline and 6 months|we analyzed the weight at the end of study completion|||kg||Standard Deviation|Mean
2754528|NCT00845039|Secondary|Objective Response Rate (ORR) [Complete Response (CR) + Partial Response (PR)]||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754513|NCT00845130|Primary|Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier|Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.|2 hour post infusion|Data from one healthy subject were not usable due to subject's movement during MRI scan.|||µmol/g tissue||Standard Deviation|Mean
2754514|NCT00845130|Primary|Concentration of Vitamin C in Type 2 Diabetic Patients.|Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.|Pre-Vitamin C infusion|Determine cerebral concentrations of vitamin C. Data from one healthy subject were not usable due to subject's movement during MRI scan.|||umol/g tissue||Standard Deviation|Mean
2754515|NCT00845065|Secondary|Mean Log Change From Baseline to TW 4 in Viral Load by Visit|HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units [IU]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale.|From Baseline to TW 4|FAS Population|||log10 (IU/mL)||Standard Deviation|Mean
2754516|NCT00845065|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12||Follow-up Week 12|FAS Population|||Participants|||Number
2754517|NCT00845065|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR|EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive.|Day 1 to Treatment Week 12|FAS Population|||Percentage of Participants|||Number
2754518|NCT00845065|Secondary|SVR Rate in the Modified Intent-to-Treat (mITT) Population|SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population.|Follow-up Week 24|mITT Population: all randomized participants who received at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included. FU W12 value was LOCF, if last SVR value at or after FU W24 was not available.|||Percentage of Participants|||Number
2754519|NCT00845065|Primary|Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.|SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).|Follow-up Week 24|FAS Population: all randomized participants who received at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo). Follow-up (FU) Week (W) 12 value was Last Observation Carried Forward (LOCF), if last SVR value at or after FU W24 was not available.|||Percentage of Participants|||Number
2754520|NCT00845039|Other Pre-specified|The Number of Participants Who Died During 30-Day Follow-Up|Reported are the deaths during the 30-day follow-up period regardless of causality.|26.3 months post-randomization up to 30-day post-treatment follow-up|All randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2754521|NCT00845039|Secondary|Serum Anti-IMC-A12 Antibody Assessment||Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754522|NCT00845039|Secondary|Change in Behavioral and Health Outcomes [BAHO] Quality of Life (QoL) Questionnaire||Baseline, after Cycle 3 (14-day cycle), study discontinuation 30-day follow-up (up to 26.3 months)|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754523|NCT00845039|Secondary|Post-treatment Serum Levels of IMC-A12 in Participants Receiving IMC-A12||Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754524|NCT00845039|Secondary|Toxicity of the Irinotecan + Cetuximab + IMC-A12 Regimen||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754525|NCT00845039|Secondary|The Number of Participants Who Had a Complete Resection/Ablation of Metastases With no Evidence of Disease Remaining (Resection Rate)||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754526|NCT00845039|Secondary|Progression Free Survival (PFS) Over Entire Duration||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754527|NCT00845039|Secondary|Overall Survival (OS)||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2755701|NCT00837148|Primary|Overall Objective Response|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|at 18 weeks||||participants|||Number
2754529|NCT00845039|Primary|Progression-Free Survival (PFS) Rate at 18 Weeks||Approximately 18 Weeks|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
2754530|NCT00845000|Secondary|Mean Peak Walking Speed|Walking speed assessment began with the participant being seated in an armless chair. Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat. Timing was stopped when the participant's buttocks hit the chair and the total time was recorded. If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair. Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit. Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8. The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved. The mean peak walking speed was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||Seconds||Standard Deviation|Mean
2754531|NCT00845000|Secondary|Mean Peak Tremor Score|Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks). Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The tremor score was the sum of scores for seven body parts. The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors. The mean peak tremor score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||Score on a scale||Standard Deviation|Mean
2754532|NCT00845000|Secondary|Mean Peak Finger Tapping Score|Tapping was measured with two manual counters with keys that were depressed to register a count. The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap. The participant was instructed to tap as rapidly as possible while being timed for 60 seconds. The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved. The mean peak finger tapping score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||taps per 60 seconds||Standard Deviation|Mean
2754533|NCT00845000|Primary|Mean Peak Dyskinesia Score|Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||Score on a scale||Standard Deviation|Mean
2754534|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (5-18 Year Old Version) is a 3-item questionnaire with scores ranging from 0-18. A higher score is indicative of worse outcomes. Used for five year olds in the study. Change in scores were observed from baseline to six month follow-up.|baseline and six month follow-up|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2754535|NCT00844896|Primary|DEF Participation|Outcomes in this measure were quantified by the number of participants in either intervention (DEF-only or COPE+DEF). During the study, DEF intervention was part of the standard of care for all patients at Shriners Hospitals for Children-Boston and thus every participant in this study had been evaluated using DEF to determine distress, emotional and family support.|Baseline|Intentional to treat (ITT)|||participants|||Number
2754536|NCT00844896|Primary|Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months|Stanford Acute Stress Reaction Questionnaire is a 31-question self-report measure for acute stress in parents. Scores range from 0-155 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2754537|NCT00844896|Primary|Change From Baseline in Hospital Emotional Support Form From Six Months|Hospital Emotional Support Form is a 12-question form that rates parents/caregivers need for in-hospital emotional support. Scores range from 11-24, with a lower score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2754538|NCT00844896|Primary|Change From Baseline in PTSD Semi-Structured Interview at Six Months|Posttraumatic Stress Disorder Semi-Structured Interview is based on DSM-IV criteria, with a higher score indicative of increased symptoms of PTSD. The total rating was scored from 19 questions in three clusters of symptoms, with a score range of 0-38. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2754539|NCT00844896|Primary|Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month|Child Stress Reaction Checklist Short Form is a 9-item parent-rated checklist. Scores range from 0-18 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2754540|NCT00844896|Primary|Change From Baseline in Parenting Stress Index at Six Months|Parenting Stress Index is a 12-item parent-rated questionnaire which employs a 1-5 Likert scale. Scores range from 12-60, with a lower score indicative of worse outcomes and a cutoff of 15. Change in scores were observed from baseline to six month follow-up.|Baseline and six month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2754541|NCT00844896|Primary|Change From Baseline in Pediatric Symptom Checklist at Six Months|Pediatric Symptom Checklist is an 18-item psychosocial checklist in which symptoms are rated from 0 (never) to 2 (often) and the last question is rated as yes or no (0 or 1). Items are summed and the score can range from 0-35, with a higher score indicative of more symptoms and a worse outcome. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2754542|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2754543|NCT00844883|Secondary|Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE|Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.|3 years||||Hazard ratio||95% Confidence Interval|Number
2754544|NCT00844883|Secondary|Efficacy - Overall Survival (OS) After Combination Treatment With Sorafenib and TACE|"Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.~All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib."|3 years||||months||Inter-Quartile Range|Median
2754545|NCT00844883|Secondary|Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE|"Time to progression (TTP) - defined as the time from initiation of therapy to disease progression (radiological). Median TTP calculated for all subjects and stratified by Barcelona Clinic Liver Cancer (BCLC) staging.~46 patients out of 50 were reviewed for this outcome. 3 patients were excluded because they underwent liver transplantation and 1 patient was excluded for hepatic resection."|3 years|Median TTP stratified by BCLC staging; 3 patients had BCLC stage A disease, 14 with stage B, and 29 with stage C.|||months||Inter-Quartile Range|Median
2754546|NCT00844883|Secondary|Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate|"Efficacy as assessed by radiographic tumor response using the EASL criteria at baseline and at 6 months post the initiation of treatment.~Complete response (CR): 100% tumor necrosis Partial Response (PR): more than 50% tumor necrosis Progressive Disease (PD): increase in tumor enhancement by more than 25% Stable Disease (SD): Cases that do not qualify for one of the above criteria"|6 months|32 out of the 50 patients had imaging assessable by EASL criteria at 6 months - 18 out of the original 50 had exited prior to this time point or did not have applicable imaging.|||Participants|||Count of Participants
2754547|NCT00844883|Secondary|Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate|"Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6 months post the initiation of treatment. 33 out of the original 50 patients were evaluable at this time point, with 17 out of the 50 exiting prior to 6 months or were not assessable by RECIST criteria.~Complete response (CR): Disappearance of all lesions targeted with therapy Partial Response (PR): at least 30% decrease in sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): at least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD"|6 months|33 out of the original 50 patients were evaluable for this outcome, with 17 out of the original 50 exiting prior to 6 months or were not assessable by RECIST criteria.|||Participants|||Count of Participants
2754548|NCT00844883|Primary|Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.|Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more.|2 years (Cycles 2-5+)|39 patients were reviewed for toxicities for Cycle 2-5+. 11 patients out of the original 50 exited the study prior to Cycle 2.|||# of participants with adverse events|||Number
2754549|NCT00844883|Primary|Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.|Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more. 50 patients were reviewed for toxicities for Cycle 1, and all 50 patients experienced at least one adverse event during this time period.|6 weeks (Cycle 1)||||# of participants with adverse events|||Number
2754550|NCT00844857|Other Pre-specified|Change From Baseline in Electrocardiogram (ECG) QTcF Interval Up to Week 8|QTcF is defined as ECG QT interval corrected for heart rate using the Fridericia correction factor.|Baseline, Week 8|Population analyzed M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and QTcF at baseline and at least 1 post-baseline measurement; LOCF.|||millisecond (msec)||Standard Error|Least Squares Mean
2754551|NCT00844857|Other Pre-specified|Change From Baseline in Prolactin Up to Week 8|Prolactin LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and prolactin at baseline and at least 1 post-baseline measurement; LOCF.|||microgram/Liter (μg/L)||Standard Error|Least Squares Mean
2755702|NCT00837096|Primary|Number of Participants With 100% Wound Closure||Day 84||||Participants|||Count of Participants
2754552|NCT00844857|Other Pre-specified|Change From Baseline in Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) Up to Week 8|ALT/SGPT LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ALT/SGPT at baseline and at least 1 post-baseline measurement; LOCF.|||units/Liter (U/L)||Standard Deviation|Least Squares Mean
2754553|NCT00844857|Other Pre-specified|Change From Baseline in Fasting Metabolic Parameters Up to Week 8|Fasting glucose, fasting cholesterol and fasting triglycerides. LS means were adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and fasting glucose, cholesterol and triglycerides at baseline and at least 1 post-baseline measurement; LOCF.|||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
2754554|NCT00844857|Other Pre-specified|Change From Baseline in Weight Up to Week 8|Weight LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and weight at baseline and at least 1 post-baseline measurement; LOCF.|||kilogram (kg)||Standard Error|Least Squares Mean
2754555|NCT00844857|Other Pre-specified|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Kid and Kiddo Combined Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Kid-KINDL was administered to ages 8-11 and Kiddo-KINDL to ages 12-16. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and had KINDL Kid and Kiddo results at baseline and at least 1 post-baseline measurement. Due to small number of 10- and 11-year olds results from the 2 versions were pooled; LOCF.|||units on a scale||Standard Error|Least Squares Mean
2754556|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Dyskinesia Up to Week 8|Dyskinesia was measured using the Abnormal Involuntary Movement Scale (AIMS) a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a patient. Total score (0-40) is obtained by adding the scores of the first 10 items. An abnormal result is defined as having a score ≥3 for at least 1 of the first 7 items or a score ≥2 for at least two of the first 7 items.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
2754557|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Parkinsonism Up to Week 8|Parkinsonism was measured using the Simpson-Angus Scale with a total scores range from 0 to 40. A score > 3 was considered abnormal. Simpson-Angus Scale consists of 10 items, each rated on a 5-point scale, 0 (complete absence of the condition) to 4 (presence of the condition in extreme form).|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
2754558|NCT00844857|Secondary|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and KINDL Parent Scale at baseline and at least 1 post-baseline measurement; LOCF.|||units on a scale||Standard Error|Least Squares Mean
2754559|NCT00844857|Secondary|Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8|Attention Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS-IV-PI): Investigator Administered and Scored measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Scores range: 0 to 54. The LS mean was adjusted for baseline and treatment.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ADHDRS-IV-PI results at baseline and at least 1 post-baseline measurement; LOCF.|||units on a scale||Standard Error|Least Squares Mean
2754560|NCT00844857|Secondary|Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8|Worsening of mania was defined as YMRS score of ≥20 and a CGI severity of mania score of ≥ 5 at the same visit. The YMRS is an 11-item scale measuring severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) with remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. CGI measures severity of the participant's overall severity of bipolar symptoms and scores range from 1 (normal) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites with YMRS and CGI total scores at baseline and at least 1 post-baseline measurement; LOCF.|||percentage of participants|||Number
2754561|NCT00844857|Secondary|Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8|"Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Percentage of participants with suicidal ideation, behavior, and acts are provided. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
2754562|NCT00844857|Secondary|Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8|Akathisia was measured using the Barnes Akathisia Rating Scale where the global scores range from 0 (absent) to 5 (severe) and a score ≥ 2 is considered abnormal.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
2754563|NCT00844857|Secondary|Change From Baseline in the CDRS-R Total Score Up to Week 8|CDRS-R Total score measure the presence and severity of depression in children and consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Total scores range from 17 to 113. In general, scores < 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had CDRS-R total scores at baseline and at least 1 post-baseline measurement; LOCF.|||units on a scale||Standard Error|Least Squares Mean
2754564|NCT00844857|Secondary|Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8|CGI-BP measures severity of illness for bipolar illness. Scores range: 1 (normal, not ill at all) to 7 (among the most extremely ill patients). LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had CGI-BP total scores at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2754565|NCT00844857|Secondary|Change From Baseline in the YMRS Total Score at Week 8|The YMRS is an 11-item scale measuring the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total scores ranges: 0 to 60. LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had YMRS total scores with a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2754566|NCT00844857|Secondary|Percentage of Participants in Each Improvement Category Up to Week 8|CDRS-R scores: No/low improvement is < 25 percent (%) of maximum reduction from baseline. Mild improvement: maximum reduction from baseline on CDRS-R score ≥ 25% up to <50% and YMRS elevated mood score ≤ 2. Moderate improvement: maximum reduction from baseline on CDRS-R score ≥50% and <75% and YMRS elevated mood score ≤ 2. Major improvement: maximum reduction from baseline on CDRS-R score ≥75% and YMRS elevated mood score ≤ 2. CDRS-R measures presence/severity of depression in children. Scale is 17 items scored 1-to-5- or 1-to-7. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores < 20 absence of depression, scores 20 to 30 borderline depression, scores 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures severity of manic episodes. Four items rated 0 (symptoms not present) to 8 (symptom extremely severe). Remaining items rated 0 (symptoms not present) to 4 (symptom extremely severe). Score range: 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both CDRS-R and YMRS total scores with a baseline and at least 1 post-baseline measurement; LOCF.|||percentage of participants|||Number
2754567|NCT00844857|Secondary|Percentage of Participants With Response Up to Week 8|Response is defined as a CDRS-R total score greater than or equal to (≥)50% reduction from baseline and YMRS elevated mood score ≤2. CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. In general, <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had all of CDRS-R and YMRS total scores at baseline and at least 1 post-baseline measurement; LOCF|||percentage of participants|||Number
2754568|NCT00844857|Secondary|Percentage of Participants With Remission Up to Week 8|Remission is defined as a CDRS-R total score less than or equal to (≤)28, and Young Mania Rating Scale (YMRS) total score ≤ 8 and Clinical Global Impressions-Bipolar Version (CGI-BP) total score ≤3. CDRS-R is a 17-item scale measuring presence/severity of depression in children and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, scores 40 to 60 indicate moderate depression. The YMRS is an 11-item scale measuring severity of manic episodes; 4 items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe) with remaining items rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). YMRS score ranges from 0 to 60. CGI-BP measures participant's overall severity of bipolar symptoms. Scores range: 1 (normal, not at all ill ) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both the CDRS-R, YMRS and CGI-BP total scores at baseline and at least 1 post-baseline measurement; Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2754580|NCT00844844|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study visit for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2754581|NCT00844831|Secondary|Small Intestinal Bacterial Overgrowth (SIBO)|SIBO was measured before and after treatment.|28 days||||participants|||Number
2754569|NCT00844857|Primary|Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8|CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (*) visit interaction.|Baseline, Week 8|Population analyzed was the Modified Intention-to-Treat (M-ITT) Population: defined as all randomized participants who took at least 1 dose of study drug and excluding participants from 2 Good Clinical Practice (GCP) noncompliant sites and who had a baseline and at least 1 post-baseline CDRS-R measurement.|||units on a scale||Standard Error|Least Squares Mean
2754570|NCT00844844|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mil||Standard Deviation|Mean
2754571|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
2754572|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2754573|NCT00844844|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754574|NCT00844844|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754575|NCT00844844|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2754576|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
2754577|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥ 25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2754578|NCT00844844|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754579|NCT00844844|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754584|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase|"ASAS-20 response was defined as ≥20% improvement in response according to following criteria:~• An improvement of ≥20% from baseline and an absolute improvement from~baseline of ≥10 mm in at least 3 of the following 4 domains (patient global assessment, pain, function,and inflammation)~• Absence of deterioration from baseline (≥20% and an absolute change of~≥10 mm) in the potential remaining domain."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Percentage of Participants|||Number
2754585|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS-40 response was defined as ASAS achieving ≥40% improvement in 3 of the 4 domains (patient global assessment, total back pain, function, and inflammation), with an absolute improvement of ≥20 mm and no deterioration in the remaining domain.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Percentage of Participants|||Number
2754586|NCT00844805|Secondary|Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase|"The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) employs a VAS of 0mm (best) to 100mm (worst). Disease flare was defined as reaching a BASDAI of ≥30 mm during two consecutive visits after Week 28 until Week 52.~ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria was defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation)."|Week 52|The Intent-to-Treat Population consisted of all subjects who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754587|NCT00844805|Secondary|Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized to treatment, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Weeks||Full Range|Median
2754588|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active spinal inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754589|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52|EaEach sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754590|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants that were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754591|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754661|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2754592|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions at the sacroiliac joints was defined as a Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754593|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754594|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 52|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.|||Units on a Scale||Inter-Quartile Range|Median
2754595|NCT00844805|Secondary|Change From Baseline of Berlin MRI Spine Overall Score at Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 52|The number of participants represents those with a Week 28 values and those with a Week 52 value.|||Units on a Scale||Inter-Quartile Range|Median
2754596|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.|||Units on a Scale||Inter-Quartile Range|Median
2754597|NCT00844805|Secondary|Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28|MRI scans (T1 for chronic changes and short tau inversion recovery [STIR] for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.|||Units on a Scale||Inter-Quartile Range|Median
2754598|NCT00844805|Secondary|Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Percentage of Participants|||Number
2754599|NCT00844805|Secondary|Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754600|NCT00844805|Primary|Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28|ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
2754601|NCT00844753|Primary|Percentage of Participants Who Were Autism Spectrum Disorder Respondents|"Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire - Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale.~The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill),"|week 10||||percentage of participants|||Number
2754838|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 2||Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Participants|||Number
2754602|NCT00844753|Primary|Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents|Respondents were defined as having ≥30% decrease on the SNAP and CGI-I<=2). The Swanson, Nolan, and Pelham (SNAP)-IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit.|week 10||||percentage of participants|||Number
2754603|NCT00844714|Primary|Flow-mediated Vasodilation (FMD)|endothelial function as assessed by flow-mediated vasodilation of the brachial artery|12 weeks, 24 weeks||||percentage change in diameter||Inter-Quartile Range|Median
2754604|NCT00844649|Other Pre-specified|Number of Participants With Dose Delays/Doses Not Given|The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.|Up to 666 days|Treated Population|||number of dose delays|||Number
2754605|NCT00844649|Other Pre-specified|Number of Participants With Dose Interruptions|The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Safety population, includes participants who received at least one study treatment|||participants|||Number
2754606|NCT00844649|Other Pre-specified|Number of Participants With Dose Reductions|The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Treated Population|||participants|||Number
2754607|NCT00844649|Other Pre-specified|Participants With Treatment Emergent Adverse Events (AE)|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days|Treated patient population|||participants|||Number
2754608|NCT00844649|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)|Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months|Intent to Treat population (ITT population) consisted of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2754609|NCT00844649|Secondary|Progression-free Survival (PFS) by Independent Radiological Review (IRR)|Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.|Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.|||months||95% Confidence Interval|Median
2754610|NCT00844649|Primary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.|From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.|||months||95% Confidence Interval|Median
2754611|NCT00844597|Post-Hoc|Adverse Events >15%|Adverse events that occurred in >15% of overall patient population across dose level arms.|27 Weeks|Safety Population|||Events|||Number
2754612|NCT00844597|Primary|Treatment Emergent Adverse Events|Number of Patients with Treatment Emergent Adverse Events|from Baseline to Follow up (27 weeks)|Safety Population|||participants|||Number
2754613|NCT00844597|Secondary|Efficacy of Eteplirsen Over 12 Weeks of Dosing|Efficacy was defined as an estimated change in the percentage of dystrophin positive fibers (assessed by IHC) at Week 14 from Baseline after 12 weekly doses of eterplirsen. This outcome measure represents the number of patients to show an increase in the percentage of dystrophin-positive fibers.|Biopsies were taken at Baseline and Week 14|Per Protocol Population - Included all patients who received all 12 doses of study treatment.|||participants|||Number
2754614|NCT00844597|Secondary|Pharmacokinetics - Mean Peak Plasma Concentration of AVI-4658 After Administration|Standard Pharmacokinetic parameters estimated using non-compartmental modeling of plasma concentration data.|Samples were taken: 30 minutes pre dose; and at 5 (±1), 15 (±2), 30 (±5), 60 (±5), and 90 (±5) minutes; and 2, 4, 6, 8, 12, and 24 hours (all ± 15 minutes) post dose at Weeks 1, 6, and 12|PK Evaluable Population: Included all patients who provided at least 1 PK sample. The reportable PK population included those patients with at least Cmax, Tmax, and AUC0-24 computed from 1 or more of the 3 sampling days (1st, 6th, 12th dose [Weeks 1, 6, and 12]).|||ng/mL||Standard Deviation|Mean
2754615|NCT00844597|Primary|Safety and Tolerability|Number of subjects with 1 or more Treatment Emergent Adverse Event that are possibly related to the investigational drug|Baseline to 6 months|Safety Population - Any patient who received at least one dose of the study drug.|||participants|||Number
2754616|NCT00844558|Secondary|Change in Chair Stand Time|Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.|0,3,6,and 12 months||||seconds||95% Confidence Interval|Mean
2754617|NCT00844558|Secondary|Change in Stair Climb Time, Secs|Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)|0,3,6, and 12 months||||seconds||95% Confidence Interval|Mean
2754618|NCT00844558|Secondary|Change in Long Distance Corridor Walk (LDCW) Time, Secs|The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.|0,3,6 and 12 months||||seconds||95% Confidence Interval|Mean
2754619|NCT00844558|Secondary|Change in KOOS Symptoms|"This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.~Scored from 0 to 100 with 100 indicating no symptoms."|0,3,6 and 12 months||||units on a scale||95% Confidence Interval|Mean
2754620|NCT00844558|Secondary|Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain|"This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.~Scored from 0 to 100 with 100 indicating no pain."|0,3,6 and 12 months||||units on a scale||95% Confidence Interval|Mean
2754621|NCT00844558|Primary|Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument|"This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities.~Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance)."|0,3,6, and 12 months||||units on a scale||95% Confidence Interval|Mean
2754622|NCT00844545|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mil||Standard Deviation|Mean
2754623|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
2754624|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2754625|NCT00844545|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754626|NCT00844545|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754627|NCT00844545|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2754628|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
2754629|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2754630|NCT00844545|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754631|NCT00844545|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754632|NCT00844545|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2754633|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754634|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754635|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754636|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754637|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754638|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754902|NCT00843635|Secondary|Optimal Dosing Schedule for Tadalafil||Baseline, End of Treatment at Time of Surgery.|Optimal dosing schedule of Tadalafil not determined due to no proven superiority of one dosing arm over the other.||||||
2754639|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2754640|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2754641|NCT00844532|Secondary|Stent Thrombosis|Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2754642|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754643|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754644|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|18 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754645|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754646|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
2754647|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
2754648|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
2754649|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
2754650|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754651|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754652|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754653|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754654|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|3 years|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2754662|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2754663|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2754664|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2754665|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population.This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
2754666|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
2754667|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
2754668|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
2754669|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754670|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754671|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754672|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754673|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|3 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754694|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
2754674|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|2 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754675|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754676|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|1 month and 9 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2754677|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754678|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754679|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754680|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754681|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754682|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754683|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2756816|NCT00829933|Secondary|Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.||12 weeks|||||||
2754684|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2754685|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754686|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754687|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754688|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754689|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754690|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754691|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754692|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754693|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
2754695|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
2754696|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
2754697|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
2754698|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|Pre-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
2754699|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754700|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754701|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754702|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754703|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Post-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754704|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754705|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754706|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754707|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754708|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754709|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2754710|NCT00844532|Secondary|Procedure Success|Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population|||percentage of participants||95% Confidence Interval|Number
2754711|NCT00844532|Secondary|Technical Success|Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.|acute: from beginning of index procedure to end of index procedure.|ITT population|||percentage of target lesions|Participants|95% Confidence Interval|Number
2754712|NCT00844532|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|acute: from beginning of index procedure to end of index procedure.|Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.|||percentage of devices|Participants|95% Confidence Interval|Number
2754713|NCT00844532|Primary|Major Adverse Event (MAE) Rate|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants||95% Confidence Interval|Number
2754714|NCT00844519|Primary|Percent Change in FMD|endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery|Baseline, 24 weeks||||percent change in FMD||Standard Deviation|Mean
2754715|NCT00844480|Secondary|BMD at Other Skeletal Sites|BMD at spine, femoral neck, distal femur, proximal tibia, heel|6 months|heel measurements were not performed|||percentage of baseline BMD||Standard Deviation|Mean
2754716|NCT00844480|Primary|Bone Mass Density (BMD) at Total Hip|bone mineral density measured by DXA at the total hip|6 months||||%change in BMD from baseline||Standard Deviation|Mean
2754717|NCT00844428|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.|||micrograms/mil||Standard Deviation|Mean
2754718|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754719|NCT00844428|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2754720|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
2754721|NCT00844428|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2754722|NCT00844428|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754723|NCT00844428|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754724|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754725|NCT00844428|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2754726|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
2754727|NCT00844428|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2754728|NCT00844428|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754729|NCT00844428|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2754730|NCT00844415|Secondary|Occurences of Clinical Outcome|Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.|3 days|TS|||Participants|||Number
2754731|NCT00844415|Secondary|Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs|Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.|Baseline and 3 days|TS|||Participants|||Number
2754732|NCT00844415|Secondary|Ecarin Clotting Time (ECT)|Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
2754733|NCT00844415|Secondary|aPTT Locally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
2754734|NCT00844415|Secondary|Activated Partial Thromboplastin Time (aPTT) Centrally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
2754735|NCT00844415|Primary|TT Locally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
2754736|NCT00844415|Primary|Thrombin Time (TT) Centrally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
2754737|NCT00844415|Primary|Plasma Concentration of Total Dabigatran|Plasma concentration of total dabigatran measured at 72 hours after first dose|Day 3|TS with non-sparse data|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2754738|NCT00844415|Primary|Plasma Concentration of Free Dabigatran|Plasma concentration of free dabigatran measured at 72 hours after first dose|3 days|Treated Set. Descriptive statistics for the concentration measurement could only be calculated for the subgroups of patients receiving the same sequence of doses. Statistics were only reported for groups with at least 3 patients (non-sparse data).|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2754739|NCT00844415|Primary|Number of Patients With Adverse Events|"Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered on-treatment if occurring within 72 hours after last drug administration."|From Screening until 30 days after first drug administration (end of trial visit)|TS|||Participants|||Number
2754764|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores of a scale||Standard Deviation|Mean
2756829|NCT00829790|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2754740|NCT00844415|Primary|Number of Patients With Bleeding Events (Major and Minor)|"Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:~Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds."|From Screening until 30 days after first drug administration (end of trial visit)|Treated set (TS). This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||Participants|||Number
2754741|NCT00844376|Secondary|Plasma Elimination Half-life (t1/2)|Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.|5 days||||hr||Standard Deviation|Mean
2754742|NCT00844376|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).|5 days||||hr||Full Range|Median
2754743|NCT00844376|Secondary|Terminal Phase Rate Constant (Kel)|Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).|5 days||||1/hr||Full Range|Geometric Mean
2754744|NCT00844376|Primary|Maximum Observed Plasma Concentration (Cmax)|Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).|5 days||||ng/mL||Full Range|Geometric Mean
2754745|NCT00844376|Secondary|Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)|Geometric mean of AUClast = area under the plasma concentration-time curve from time zero (0) to the last measurable concentration of atorvastatin (test vs reference); measured as ng.hr/mL|5 days||||ng.hr/mL||Full Range|Geometric Mean
2754746|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)|Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).|5 days||||ng.hr/mL||Full Range|Geometric Mean
2754747|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)|Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).|5 days||||ng.h/mL||Full Range|Geometric Mean
2754748|NCT00844298|Secondary|Overall Survival||2 years|||||||
2754749|NCT00844298|Secondary|Disease(Relapse)-Free Survival||2 years|||||||
2754750|NCT00844298|Primary|Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy|approximate time: at the recovery of cytopenia|1 month||||percentage of analyzable subjects|||Number
2754751|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754752|NCT00844194|Secondary|Change of Pulse Rate From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2754753|NCT00844194|Secondary|Change of Diastolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2754754|NCT00844194|Secondary|Change of Systolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2754755|NCT00844194|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.|||percent||95% Confidence Interval|Least Squares Mean
2754756|NCT00844194|Secondary|Change of Fasting Blood Glucose From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.|||mg/dL||95% Confidence Interval|Least Squares Mean
2754757|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.|||Participants|||Number
2754758|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.|||Participants|||Number
2754759|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.|||Participants|||Number
2754760|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.|||Participants|||Number
2754761|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.|||Participants|||Number
2754762|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.|||Participants|||Number
2754763|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754836|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Participants|||Number
2754765|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754766|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 12||||Scores of a scale||Standard Deviation|Mean
2754767|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754768|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754769|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12|Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754770|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6|Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754771|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12|Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754772|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6|Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754773|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754774|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754775|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12|Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754776|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6|Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754777|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754778|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754779|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754780|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754781|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754782|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754783|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754784|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754785|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754786|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754787|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754788|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754789|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754790|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754791|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2755943|NCT00835263|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2754792|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754793|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754794|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754795|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754796|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754797|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754798|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754799|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754800|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754801|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754802|NCT00844194|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754803|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754804|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754805|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754837|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 6||Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Participants|||Number
2754806|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 12|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754807|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 6|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754808|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 2|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754809|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754810|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754811|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754812|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754813|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754814|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754815|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754816|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754817|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754818|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754819|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754820|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754821|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754822|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754823|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754824|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754825|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754826|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754827|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754828|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754829|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754830|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12|The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||scores on a scale||Standard Deviation|Mean
2754831|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6|The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||scores on a scale||Standard Deviation|Mean
2754832|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2|The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||scores on a scale||Standard Deviation|Mean
2754833|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 12|The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754834|NCT00844194|Secondary|Change in Pain (BPI) From Baseline to Week 6|The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754835|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 2|The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754839|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754840|NCT00844194|Secondary|Change in Average Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754841|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754842|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754843|NCT00844194|Secondary|Change in Least Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754844|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754845|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754846|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754847|NCT00844194|Secondary|Change in BPI Worst Pain During Treatment From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754848|NCT00844194|Secondary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754849|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
2754850|NCT00844090|Primary|Change in HbA1c Over Baseline|measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months|6 months from baseline|per protocol|||percentage of HbA1c||Standard Deviation|Median
2754851|NCT00844051|Secondary|Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year||||days per 100 school days||Standard Deviation|Mean
2754852|NCT00844051|Primary|Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year||||flu+ per 1000 children|||Number
2754853|NCT00843986|Secondary|Total Urine Output at Hours 6, 12, 24, 48 and 72|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754854|NCT00843986|Secondary|Total Loop Diuretic Use Through 48 Hours|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754855|NCT00843986|Secondary|Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754903|NCT00843635|Primary|Ratio of Tumor-specific T-cell Concentration in the Blood|Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at Time of Surgery|Data for 31 patients were analyzed.|||ratio from baseline||Inter-Quartile Range|Median
2754856|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity).~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754857|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~Changes in Dyspnea were assessed using the following 7-point Likert scale:~1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754858|NCT00843986|Secondary|Termination of Study Drug Due to an Adverse Event or Intolerability|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48.5 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754859|NCT00843986|Secondary|Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Day 9|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754860|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance|"Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation.~MDRD = Modification of Diet in Renal Disease~The MDRD equation is a standard calculation for estimated glomerular filtration rate.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 24 Hours, 48 Hours and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754861|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754862|NCT00843986|Primary|Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|24 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754863|NCT00843986|Primary|Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)|"MDRD = Modification of Diet in Renal Disease~The MDRD equation is a standard calculation for estimated glomerular filtration rate.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
2754864|NCT00843856|Secondary|Number of Patients Achieved Remission|The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate.|6-12 months||||Participants|||Count of Participants
2754865|NCT00843856|Primary|Number of Patient Who Gained Remission From the Nephrotic Syndrome|Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.|10-109 weeks||||Participants|||Count of Participants
2754866|NCT00843843|Secondary|Psychomotor Vigilance|Fastest 10% reaction time (msec)|after short or long nights|Means|||msec||Standard Deviation|Mean
2754867|NCT00843843|Primary|Dim Light Melatonin Onset (Hours)|Gold standard marker of circadian timing|12 days from baseline to final dim light melatonin onset||||hours||Standard Deviation|Mean
2754868|NCT00843830|Secondary|Number of Patients That Respond to Treatment|To evaluate the anti-tumor response as determined by RECIST criteria|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.||||||
2754869|NCT00843830|Primary|The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.|The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.||||||
2754870|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 12|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754871|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 10|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754904|NCT00843635|Primary|Ratio of T-reg Cell Concentration in the Blood|Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..|Baseline, End of Treatment at Time of Surgery||||ratio from baseline||Inter-Quartile Range|Median
2754872|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 8|Of the 130 subjects in the Full Analysis Set, 34 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754873|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 6|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754874|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 4|Of the 130 subjects in the Full Analysis Set, 35 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754875|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 2|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754876|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 0|Of the 130 subjects in the Full Analysis Set, 31 subjects are included in the analysis of this outcome measure, based upon the number of subjects receiving hospital nurse injection at this visit, with an available assessment score at the visit.|||units on a scale||Standard Deviation|Mean
2754877|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 12|Of the 130 subjects in the Full Analysis Set, 74 or 75 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754878|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 10|Of the 130 subjects in the Full Analysis Set, 72, 73 or 74 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754879|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 8|Of the 130 subjects in the Full Analysis Set, 78, 79 or 80 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754880|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 6|Of the 130 subjects in the Full Analysis Set, 66, 67 or 68 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754881|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 4|Of the 130 subjects in the Full Analysis Set, 82 or 83 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754882|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 2|Of the 130 subjects in the Full Analysis Set, 80 or 81subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754883|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 65 or 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754884|NCT00843778|Secondary|Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The three domains of the PRE SIAQ are feelings about injections, self-confidence, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting completed this pre-self-injection questionnaire. The PRE-SIAQ is taken before the subject's first injection.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
2754885|NCT00843778|Secondary|Percentage of Subjects Willing to Self-inject at Week 0|The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.|Week 0 of this study (C87080 [NCT00843778])|Full Analysis Set|||percentage of participants|||Number
2754886|NCT00843778|Secondary|Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study|Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Safety Set|||percentage of participants|||Number
2754887|NCT00843778|Secondary|Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Values below the limit of quantification of 0.41 μg/mL will be set to half the limit of quantification for the summaries (0.205 μg/mL).|Week 24|Of the 130 subjects in the Safety Set, 89 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||μg/mL||95% Confidence Interval|Geometric Mean
2754888|NCT00843778|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754889|NCT00843778|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|"Change from Baseline in Fatigue Assessment Scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement."|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 117 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754890|NCT00843778|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 102 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
2754891|NCT00843778|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Median
2754892|NCT00843778|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
2754893|NCT00843778|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
2754894|NCT00843778|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
2754895|NCT00843778|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. <= 3.3 (Remission), >3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 120 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
2754896|NCT00843778|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. A lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 122 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
2754897|NCT00843778|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 114 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
2754898|NCT00843778|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|From Entry Visit up to approximately 144 weeks|Safety Set|||percentage of participants|||Number
2754899|NCT00843778|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.|From Entry Visit up to approximately 144 weeks|Safety Set|||percentage of participants|||Number
2754900|NCT00843713|Primary|Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)|Measurements in the change of brachial artery diameter from pre and post treatment.|24 weeks||||millimeters||Inter-Quartile Range|Median
2754901|NCT00843635|Secondary|Number of Participants Experiencing Adverse Events|Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events|From Day 1 to Day 20||||participants|||Number
2754905|NCT00843635|Primary|Ratio of MDSC Concentration in the Blood|Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at time of Surgery||||ratio from baseline||Inter-Quartile Range|Median
2754906|NCT00843622|Secondary|Continuous Smoking Cessation|Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits|6-16 weeks|||||||
2754907|NCT00843622|Secondary|Point Prevalence Smoking Cessation|7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less|6, 16, 28 weeks|||||||
2754908|NCT00843622|Secondary|Biomarkers||Baseline, week 6, 16, and 28|||||||
2754909|NCT00843622|Secondary|Fagerström Test for Nicotine Dependence||Baseline, week 16 and 28|||||||
2754910|NCT00843622|Secondary|Minnesota Nicotine Withdrawal Scale||Baseline, week 6, 10, 16 and 28|||||||
2754911|NCT00843622|Primary|Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm||Week 6-28||||participants|||Number
2754912|NCT00843518|Secondary|Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12|ADAS-Cog14, a 14-item rating scale, measured the severity of cognitive dysfunction in persons with AD. Scores ranged from 0 to 90, with a higher score indicating worse cognitive functioning. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline ADAS-Cog, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754913|NCT00843518|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12|CGI-S-GF was a 7-point, single-item rating scale for overall functioning based on the investigator's general clinical experience with a similar participant population. This Likert scale ranged from 0 (normal) to 7 (most severely ill). LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CGI-S-GF, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754914|NCT00843518|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12|CGI-S-A/A was a 7-point, single-item rating scale for overall severity of symptoms based on the investigator's general clinical experience with a similar participant population. This Likert scale ranged from 0 (normal) to 7 (most severely ill). LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CGI-S-A/A, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754915|NCT00843518|Secondary|Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12|FrSBe was a 46-item, caregiver-rated scale that assessed behaviors associated with damage to the frontal lobes and frontal systems of the brain, including executive function, disinhibition, and apathy. Raw scores were normalized to T-scores based on gender, education, and age. Higher T scores represent a worse outcome. A score of 50 reflects a normative sample, and T scores at or above 65 are considered clinically significant. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline FrSBe, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754916|NCT00843518|Secondary|Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12|CSDD was a 19-item, clinician-rated scale designed to measure the presence and severity of depressive symptoms in dementia participants. Symptoms were rated as absent, mild/intermittent, or severe. Scores ranged from 0 to 38; scores of 8 or more suggested clinical depression. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CSDD, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754917|NCT00843518|Secondary|Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12|CMAI-C is the Cohen-Mansfield Agitation Inventory - Community Version, and it contained 36 questions. The first 35 items were rated from 1 (never) to 7 (several times per hour) and the last item asked if there was any other inappropriate behavior, with a free text field to specify the behavior. The total score ranged from 7 to 245 (7 x 35), with higher scores reflecting more severe agitation. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CMAI-C, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754918|NCT00843518|Secondary|Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12|The NPI Psychosis subscale score was the sum of the delusions and hallucinations items of the standard 12-item NPI that measured psychosis symptoms in participants with Alzheimer's dementia. Scores for each subscale (frequency x severity) were calculated for each item score and ranged from 0 to 24 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI psychosis, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2755108|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|3 months|Only 302 subjects (371 limbs) completed the 3 Month follow-up visit to provide data to this outcome measure.|||limbs|limbs||Count of Units
2754919|NCT00843518|Secondary|Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12|NPI Depression domain was an item of the standard 12-item NPI that measured depression in participants with Alzheimer's dementia. Scores for each subscale (frequency × severity) were calculated to obtain the item score, which ranged from 0 to 12 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI depression, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754920|NCT00843518|Secondary|Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12|NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 10-item scale of the standard 12-item NPI measured neuropsychiatric symptoms minus the appetite and sleep disturbance items. Scores for each subscale (frequency × severity) were calculated to obtain the item score. The total subscale score ranged from 0 to 120, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-10, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754921|NCT00843518|Primary|Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12|NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 4-item subscale of the standard 12-item NPI measured the neuropsychiatric symptoms of A/A, with items consisting of agitation/aggression, aberrant motor behavior, irritability/emotional lability, and disinhibition. Scores for each subscale (frequency x severity) were calculated to obtain each item score. The total subscale score ranged from 0 to 48, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. Least Squares (LS) Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-4 A/A, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2754922|NCT00843492|Secondary|Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population|||participants|||Number
2754923|NCT00843492|Secondary|Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population|||participants|||Number
2754924|NCT00843492|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) > 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population|||participants|||Number
2754925|NCT00843492|Secondary|Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population: all participants who received at least one dose of study treatment|||participants|||Number
2754926|NCT00843492|Secondary|Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact|The number of participants with VTE (defined as asymptomatic deep vein thrombosis [DVT: the formation of a blood clot in a deep vein] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism [PE]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches.|Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)|ITT Population|||participants|||Number
2755109|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|1 Week||||limbs|limbs||Count of Units
2754927|NCT00843492|Secondary|Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death|All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death.|Day 1 to complete mobilization plus 2 days (average of 35.7 study days)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2754928|NCT00843492|Primary|Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization|VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).|Day 1 to complete mobilization plus 2 days (average of 35.9 study days)|Intent-to-Treat (ITT) Population: all randomized participants with a VTE status or experiencing death. Participants without evaluation of the primary endpoint in the timeframe requested by the protocol were considered as missing data and therefore not included in the primary efficacy analysis.|||participants|||Number
2754929|NCT00843479|Secondary|GLP-1 Area Under the Curve (AUC)|Area under the curve of glucagon-like peptide (GLP-1) concentrations (measured by ELISA kit) from time 0 to 180 min during a standard meal tolerance test, calculated by the trapezoidal rule.|1 month from screening visit||||pg/ml/min||Standard Deviation|Mean
2754930|NCT00843479|Secondary|Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration|measured in fasting serum sample by ELISA kit|within 1 month from screening visit||||pg/ml||Standard Deviation|Mean
2754931|NCT00843479|Primary|Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.|Distinctive beta-cell function as measured by the disposition index - based on the acute insulin response from the arginine stimulation test versus glucose infusion rate adjusted by free fat mass from hyperglycemic clamp - in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects.|within 1 month from screening visit||||(μmol∙kg-1.min-1)||Standard Error|Mean
2754932|NCT00843479|Primary|Adaptive Beta-cell Insulin Production. The Product of Meal Tolerance Test-derived Insulinogenic Index (IGI) for Clamp-derived Insulin Sensitivity Index (ISI) in Normoglycemic Subjects After 65 Years Old in Comparison With Middle-age Normoglycemic Subjects|Beta-cell function was determinated as the beta-cell secretion measured by meal tolerance test adjusted by insulin sensitivity assessed by the hyperglycemic clamp test:Insulinogenic Index/Insulin Sensitivity Index adjusted by free fat mass|within 1 month from screening visit||||(μmol∙kg-1min-1)||Standard Deviation|Mean
2754933|NCT00843479|Primary|Glucose Infusion Rate|Whole-body insulin sensitivity, as estimated by the mean glucose infusion rate corrected for fat-free mass(FFM){mg*[kg(FFM)^-1]*min*10} at last 60 min of 180-min hyperglycemic clamp|within 1 month from screening visit||||mg*[kg(FFM)^-1]*min*10||Standard Deviation|Mean
2754934|NCT00843479|Primary|Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index|Insulin sensitivity index calculated as HOMA-IR = (Glucose * Insulin) / 22.5, where glucose is mmol/L and insulin is mili-units (mU)/L. Higher values indicate lower insulin sensitivity.|within 1 month from screening visit|minimum number required to find a significant difference between groups considering the intra-subject variation|||units on a scale||Standard Deviation|Mean
2754935|NCT00843466|Primary|Investigator Global Assessment|Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe|Wk 4||||units on a scale||95% Confidence Interval|Mean
2754936|NCT00843349|Primary|Percentage Changes in Parathyroid Hormone (PTH) Levels|Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.|||percentage of change from baseline||Standard Deviation|Mean
2754937|NCT00843349|Primary|Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels|Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.|||percentage of change from baseline||Standard Deviation|Mean
2754938|NCT00843310|Primary|Toxicity, Time to Progression & Progression Free Survival|"Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting.~Progressive Disease: requires any one or more of the following:~Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b~Urine M-component and/or (the absolute increase must be ≥200 mg/24 h~Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dl.~Bone marrow plasma cell percentage: the absolute % must be ≥10%c~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum calcium >11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder"|every 28 days during therapy and every month after therapy for 2 years|No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.||||||
2754939|NCT00843284|Secondary|Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)|"Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.|||participants|||Number
2755205|NCT00841659|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2754940|NCT00843284|Secondary|Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)|"Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms.|||participants|||Number
2754941|NCT00843284|Primary|Pain Related Sleep Interference|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.|||scores on a scale||Standard Deviation|Mean
2754942|NCT00843284|Primary|Daily Average Pain Scores|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.|||scores on scale||Standard Deviation|Mean
2754943|NCT00843284|Secondary|Anxiety and Depression Symptoms|The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used.|||participants|||Number
2754944|NCT00843193|Secondary|Number of Participants With Confirmed Positive Anti-GSK679586 Antibody Results After Initiation of Study Treatment|Serum samples were tested for presence of anti-GSK679586 antibodies. Blood samples were collected via an indwelling cannula or by direct venepuncture collected into a serum separator tube and allowed to clot for 1 to 2 hours. Samples were centrifuged and the resultant serum was transferred to 3 separate cryovials and stored at -80°C until shipped on dry ice to the central laboratory. Samples were analyzed in a tiered assay format. Number of participants with confirmed positive Anti-GSK679586 antibody results after initiation of study treatment were reported.|Up to Week 25|ITT Population.|||Participants|||Count of Participants
2754945|NCT00843193|Secondary|PK Parameter: Volume of Distribution|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, volume of distribution were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The volume of distribution at Day 1 indicates volume of distribution(0-1 h), Day 29 indicated volume of distribution (0-672 h) and Day 57 indicated volume of distribution (0-1344 h). Volume of distribution for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V). The 2-compartment model provided the data for volume of distribution of central compartment (V1) and volume distribution of peripheral compartment (V2).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||L/Kg||Geometric Coefficient of Variation|Geometric Mean
2754946|NCT00843193|Secondary|PK Parameter: Systemic Clearance of Parent Drug|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, systemic clearance were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The systemic clearance at Day 1 indicates systemic clearance(0-1 h), Day 29 indicated systemic clearance(0-672 h) and Day 57 indicated systemic clearance(0-1344 h). Systemic clearance of parent drug for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
2754947|NCT00843193|Secondary|PK Parameter:Maximum Observed Concentration (Cmax)|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, Cmax were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The Cmax at Day 1 indicates Cmax(0-1 h), Day 29 indicated Cmax(0-672 h) and Day 57 indicated Cmax(0-1344 h). Cmax for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
2754970|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754948|NCT00843193|Secondary|Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over the Dosing Interval (AUC (0-τ)).|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, the derived PK parameters were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The AUC at Day 1 indicates AUC(0-1 h), Day 29 indicated AUC(0-672 h) and Day 57 indicated AUC(0-1344h). AUC(0-τ) for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population comprised of participants in the ITT population for whom a pharmacokinetic samples were obtained and analyzed. Only those participants with data available at the indicated time points were analyzed.|||nanogram*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2754949|NCT00843193|Secondary|Number of Participants With Abnormal Urinanalysis Parameters of Potential Clinical Importance|Samples were collected on each visit from Week 1 to Week 25 for urinalysis. Number of participants with any abnormal urinalysis parameters of potential clinical importance are summarized here.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754950|NCT00843193|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance|Blood samples were collected on each visit from Week 1 to Week 25 to assess the clinical chemistry parameters. Albumin, Calcium, Glucose, Pottasium, Sodium and Total Carbon Di-oxide were analyzed in clinical chemistry. Number of participants with any abnormal clinical chemistry parameters of potential clinical importance are summarized here.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754951|NCT00843193|Secondary|Number of Participants With Abnormal Hematological Parameters of Potential Clinical Importance|Blood samples were collected on each visit from Week 1 to Week 25 to assess the haematological parameters. White Blood Cells count, Neutrophils, Haemoglobin, Hematocrit, Count and Lymphocytes were analyzed in haematology. Number of participants with any abnormal hematological parameters of potential clinical importance are summarized here.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754952|NCT00843193|Secondary|Number of Participants With Clinically Significant Abnormality in 12-lead Electrocardiogram (ECG)|Single 12-lead ECGs were obtained at certain visits from screening to follow-up. ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and Corrected QT (QTc) intervals. Number of participants with clinically significant abnormality in 12-lead ECG readings were summarized.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754953|NCT00843193|Secondary|Number of Participants With Abnormal Vital Signs of Potential Clinical Importance: Systolic and Distolic Blood Pressure and Heart Rate.|Vital signs including systolic and diastolic blood pressure and heart rate taken at certain visits from screening to follow-up. Potential Clinical Importance Ranges were systolic blood pressure (<85 and >160millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute [BPM]). Number of participants with abnormal systolic blood pressure, diastolic blood pressure and heart rate values of potential clinical importance were summarized.|Screening, Day -28, 1, 15, 29, 50, 57 and 169 (follow-up 3)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754954|NCT00843193|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Up to Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754955|NCT00843193|Secondary|Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period|FEV1 is forced expiratory volume in 1 second.A participant is defined as a FEV1 responder if he/she achieves a change from baseline FEV1 of >=200ml. To evaluate whether the participant was a responder over 12 weeks, change from baseline FEV1 over 12 weeks was calculated by taking the mean of the changes at Visit 7, Visit 9 and Visit 11. A binary variable was created for each participant with 1 for the responder and 0 for the non-responder. If either Visit 9 or Visit 11 FEV1 data are missing, then the binary variable for the responder over 12 weeks was set to be missing. If Visit 7 data were missing, but Visit 9 and Visit 11 data were available, then the binary variable for the responder over 12 weeks was still calculated.|Upto 12 weeks|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of Participants|||Number
2754956|NCT00843193|Secondary|Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks|FEV1 is forced expiratory volume in 1 second.Change from Baseline FEV1 was calculated for each of the following visit: Visit 6, Visit 7, Visit 9 and Visit 11. A binary variable was created for each participant with 1 for the responder and 0 for the non nonresponder at each visit. Week 1 was considered as the Baseline. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well. Change from Baseline of Week 16 and Week 24 are incorporated here which are Follow up weeks.|Week 16 and 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||mL||Standard Error|Mean
2754971|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754957|NCT00843193|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks.|FEV1 is forced expiratory volume in 1 second.Change from Baseline FEV1 was calculated for each of the following visit: Visit 6, Visit 7, Visit 9 and Visit 11. A binary variable was created for each participant with 1 for the responder and 0 for the non nonresponder at each visit. Week 1 was considered as the Baseline. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline to Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Millilitre (mL)||Standard Error|Mean
2754958|NCT00843193|Secondary|Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period.|The ACQ-7 is a 7-item questionnaire that provides a measure of a participant's asthma control. Participant responses were recorded on a 7-point scale ranging from zero (no impairment/ limitation) to 6 (total impairment/ limitation). The percentage of participants who were classified as responders for ACQ-7, defined as a clinically meaningful decrease from baseline in ACQ-7 of at least 0.50, was generally similar between treatment groups at each visit and over the 12-week treatment period.|Upto 12 weeks|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2754959|NCT00843193|Secondary|Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks|The ACQ-7 is a 7-item questionnaire that provides a measure of a participant's asthma control. Participant responses were recorded on a 7-point scale ranging from zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well. Change from Baseline of Week 16 and Week 24 are incorporated here which are Follow up weeks.|Week 16 and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Error|Mean
2754960|NCT00843193|Primary|Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks|The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline to Week 12|Intent-to-Treat (ITT) population was comprised of all participants who are randomized and receive at least the first dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Error|Mean
2754961|NCT00843180|Secondary|Days to Recovery Neutrophil Count|number of days to recovery neutrophil count >500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)|hospital stay||||number of days||95% Confidence Interval|Mean
2754962|NCT00843180|Secondary|Days of Hospital Stay|days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)|days of hospital stay after bone marrow transplant|ITT|||number of days||95% Confidence Interval|Mean
2754963|NCT00843180|Secondary|Number of Vomiting Episodes|number of vomiting episodes as reported by nurses per occurence (no upper limit)|day -7 to +21 around transplant date|ITT|||number of episodes||95% Confidence Interval|Mean
2754964|NCT00843180|Primary|Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)|days of pain >3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)|7 days pre to 21 days post transplant = 28 days|ITT no imputations|||days||95% Confidence Interval|Mean
2754965|NCT00843167|Secondary|Treatment Compliance|For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.|Baseline and end of study (up to 8 weeks)||||participants|||Number
2754966|NCT00843167|Primary|Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy|PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.|Baseline and End of Study (up to 8 weeks)|PBMCs available pre-/post-intervention.|||pmol/min/mg protein||Standard Error|Mean
2754967|NCT00843167|Primary|Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy|Ki-67 was measured through immunohistochemistry method. A modified H-score was recorded, which involved semi-quantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate staining, and 3 strong staining) and percentage of positive cells. The range of the H-score was 0-300. The maximum score indicates the strongest expression, the minimum score indicates no expression of positive tumor area.|Baseline and end of study (up to 8 weeks)|Maximum two observations (pre- and post- treatments) were expected per participant. Linear mixed effect models were used to calculate adjusted least square means (LSMEANS) and 95% confidence intervals,& to test the statistical significance of the difference between pre- and post- treatments within each group, as well as between treatment groups.|||Log 2 (H-score)||95% Confidence Interval|Least Squares Mean
2754968|NCT00843167|Primary|Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy|Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.|Baseline and end of study (up to 8 weeks)||||µM/mM creatinine||Standard Error|Mean
2754969|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with any problem and no problem at baseline versus at Week 12 LOCF"|baseline, Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2755206|NCT00841659|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2754972|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754973|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 LOCF"|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754974|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754975|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 LOCF."|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754976|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12"|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754977|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2754978|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, 12 Weeks|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754979|NCT00843115|Secondary|LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks LOCF|Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).|||score on scale||Standard Deviation|Mean
2754980|NCT00843115|Secondary|Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT): (n=286; number of subjects responding).|||score on scale||Standard Deviation|Mean
2754981|NCT00843115|Secondary|LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)|||score on scale||Standard Deviation|Mean
2754982|NCT00843115|Secondary|Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score|baseline, 12 Weeks|Intent to Treat (ITT) (n=290; number of subjects responding)|||score on scale||Standard Deviation|Mean
2754983|NCT00843115|Secondary|Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=231; number of patients responding)|||Pearson Product Correlation Coefficient|||Number
2754995|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754984|NCT00843115|Secondary|Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.|baseline, 12 Weeks|Intent to Treat (ITT). (n=207 number of subjects responding)|||Pearson Product Correlation Coefficient|||Number
2754985|NCT00843115|Secondary|LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Week LOCF|Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)|||score on scale||Standard Deviation|Mean
2754986|NCT00843115|Secondary|Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT). (n= 207; number of subjects who responded)|||score on scale||Standard Deviation|Mean
2754987|NCT00843115|Secondary|Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).|||Pearson Product Correlation Coefficient|||Number
2754988|NCT00843115|Secondary|Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.|baseline, 12 Weeks|Intent to Treat (ITT); n=207 (number of subjects who responded)|||Pearson Product Correlation Coefficient|||Number
2754989|NCT00843115|Secondary|Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)|||score on scale||Standard Deviation|Mean
2754990|NCT00843115|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.|baseline, Week 12|Intent to Treat (ITT): (n=288; number of subjects responding)|||score on scale||Standard Deviation|Mean
2754991|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754992|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754993|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754994|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755069|NCT00842608|Secondary|Hospital Length of Stay Post Randomization||Participants were followed for the duration of hospital stay, an average of 11 days||||days||Standard Deviation|Mean
2755070|NCT00842608|Primary|Days Free of Delirium and Coma||Admission through day 8 of stay||||days||Inter-Quartile Range|Median
2754996|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754997|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754998|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2754999|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755000|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755001|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755002|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755003|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755004|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755005|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755006|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755071|NCT00842543|Primary|Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys|Value at 6 months minus value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline and 6 months||||Percent Change||Standard Error|Least Squares Mean
2755007|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2755008|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
2755009|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
2755010|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.|||Participants|||Number
2755011|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.|||participants|||Number
2755012|NCT00843050|Secondary|Time to Progression|It is defined as the time from day 1 of the study drug administration until the first date of progressive disease.|End of study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.|||years||Standard Deviation|Mean
2755013|NCT00843050|Secondary|Duration of Response|It is defined as the time from when the measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively or clinically documented.|End of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.|||proportion of participants||Inter-Quartile Range|Median
2755014|NCT00843050|Primary|Best Overall Objective Response Rate|The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.|End of every 2 cycles and end of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.|||proportion of participants||Standard Deviation|Mean
2755015|NCT00843024|Other Pre-specified|Mean Body Mass Index of Participants at Baseline Categorized by Age Group|The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).|Baseline|ITT Population|||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
2755016|NCT00843024|Other Pre-specified|Mean Weight of Participants at Baseline Categorized by Age Group|The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Kilograms (kg)||Standard Deviation|Mean
2755017|NCT00843024|Other Pre-specified|Number of Participants of the Indicated Race Categorized by Age Group|The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Participants|||Number
2755018|NCT00843024|Other Pre-specified|Number of Female and Male Participants Categorized by Age Group|The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Participants|||Number
2755019|NCT00843024|Other Pre-specified|Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline|The number of participants receiving double-blind treatment were reported according to age.|Baseline|ITT Population|||Participants|||Number
2755020|NCT00843024|Other Pre-specified|Mean Age of Participants at Baseline Categorized by Age Group|The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Years||Standard Deviation|Mean
2755021|NCT00843024|Secondary|Number of Participants Nausea-free at 2 Hours Post-dose|The number of participants who did not have nausea at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755072|NCT00842543|Primary|Beta-carotene Levels Between Overweight and Lean Boys at Baseline|Value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline||||mM/L||Inter-Quartile Range|Median
2755022|NCT00843024|Secondary|Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.|Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755023|NCT00843024|Secondary|Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755024|NCT00843024|Secondary|Number of Participants Sustained Nausea-free From 2-24 Hours|Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755025|NCT00843024|Secondary|Number of Participants Sustained Phonophobia-free From 2-24 Hours|Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755026|NCT00843024|Secondary|Number of Participants Sustained Photophobia-free From 2-24 Hours|Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755027|NCT00843024|Secondary|Number of Participants Pain-free at 1 Hour Post-dose|Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.|1 hour after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755028|NCT00843024|Secondary|Number of Participants Phonophobia-free at 2 Hours Post-dose|The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755029|NCT00843024|Secondary|Number of Participants Photophobia-free at 2 Hours Post-dose|The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755030|NCT00843024|Secondary|Number of Participants Sustained Pain-free From 2-24 Hours|Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
2755031|NCT00843024|Primary|Number of Participants Who Were Pain Free at 2 Hours Post-dose|Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed.|||participants|||Number
2755032|NCT00842985|Primary|CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing|"CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.~This study used two subscales of the RVIP.~RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.~RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.~The range is from -1 to +1 ; bad to good~The numbers represent probabilities as units on a scale."|Once for each test session (4 total).|Subjects who completed all four treatment sessions. Three of these 15 subjects were not analyzed due to validity concerns of the cognitive data for at least one of the four testing sessions.|||units on a scale||Standard Deviation|Mean
2755033|NCT00842946|Primary|Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))|"The SCID (First, Spitzer, Gibbon, & Williams, 1996) is an extensively utilized structured diagnostic interview based on DSM-IV criteria. Estimates of interrater reliability range from moderate to high for most Axis I disorders (e.g., Williams et al., 1992; Zanarini~& Frankenburg, 2001)."|6-weeks post-treatment||||participants|||Number
2755034|NCT00842829|Secondary|Participants With Adverse Events (AE) Summarized by Treatment Period|Participants with treatment-emergent adverse events are summarized by each treatment period. Relation to study drug was assessed by the investigator. The 'Any AE' category below includes serious adverse events.|Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)|Safety analysis set|||participants|||Number
2755035|NCT00842829|Secondary|Participant's Global Impression of Change at the End of the Treatment Period|Global impression of change was assessed using the question 'Since the start of the study, my overall status is?'. The answer was based on a 7-point scale (1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755036|NCT00842829|Secondary|Participant's Global Assessment of Ease of Use at the End of the Treatment Period|Ease of use was assessed using the question 'Did you find this treatment easy/convenient to use for treatment of your breakthrough pain episodes?'. The answer was based on a 4-point numerical scale (0=Poor, 1=Fair, 2=Easy, 3=Very Easy). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755037|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you understand the instructions?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755038|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you feel safe taking this medication?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755039|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you find this medication comfortable to take in public?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755040|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Is this medication easy to take?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755041|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication provide adequate relief?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755042|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication work fast?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755043|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this BTP medication relieve your pain quickly so you can get back to sleep?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755044|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Satisfied with the BTP Treatment?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
2755045|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score|Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. The Global Score is the sum of the subscales (total scale is 0-70). A negative change from baseline represents an improvement.|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755046|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Enjoyment of Life|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses enjoyment of life."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755047|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses sleep."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755048|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses relations with other people."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755049|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses normal work."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755050|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses walking ability."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755051|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses mood."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755052|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses general activity."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
2755053|NCT00842829|Secondary|Participant Assessment of Medication Performance During the Treatment Period|Participants assessed the performance of FBT at 30 minutes and 60 minutes after dosing each episode during the treatment period. For each episode, the participant answered the question 'How well did your study medication perform in controlling the breakthrough pain episode?' on a 5-point Likert-type scale (poor=0, fair=1, good=2, very good=3, and excellent=4).|approximately Day 8-15|Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose.|||BTP episodes|Participants||Number
2755054|NCT00842829|Secondary|Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period|The number of breakthrough pain (BTP) episodes in which the participant did not obtain effective pain relief from study medication and took a rescue medication.|Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)|Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period.|||BTP episodes|Participants||Number
2755055|NCT00842829|Secondary|Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period|Number of participants for which an effective dose of FBT was reached as judged by each participant. The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.|||participants|||Number
2755073|NCT00842530|Other Pre-specified|Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo||Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months)|Analysis was performed on Safety Analysis Set. Here, ‘overall number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||participants|||Number
2755056|NCT00842829|Secondary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes|Overall episode data analyzed all values of time to meaningful pain relief taken over all BTP episodes during the treatment period. If meaningful pain relief was not achieved within 60 minutes of FBT intake, or if rescue medication was taken, the event was censored. Meaningful pain relief was left to the judgment of participants, who used a stopwatch and recorded the time from treatment until pain relief in a patient diary.|approximately Day 8-15|Safety analysis set consisting of participants who received at least one dose of study drug during the Treatment Period, and who recorded the time to pain relief in the patient diary.|||minutes|Participants|Inter-Quartile Range|Median
2755057|NCT00842829|Primary|Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period|The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.|||percentage of treated participants|||Number
2755058|NCT00842764|Primary|Change in Lower Eyelid Bags.|Preoperative and postoperative (postoperative visits were at day 1, 1 week, 1 month, and 2 months) .photographs were evaluated by 6 surgeons on a 5-point Likert scale which 1 indicates worsening, 2 means unchanged, 3 is mild improvement, 4 is moderate improvement, and 5 indicates complete correction.|2 months||||Participants|||Count of Participants
2755059|NCT00842751|Primary|Serum Estradiol Concentration|Area under the curve of serum estradiol|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.|||ng*hr/dL||Inter-Quartile Range|Geometric Mean
2755060|NCT00842751|Primary|Serum Dihydrotestosterone Concentration|Area under the curve of serum dihydrotestosterone|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.|||ng*hr/dL||Inter-Quartile Range|Geometric Mean
2755061|NCT00842751|Primary|Maximum Testosterone Concentration|Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.|0,1,2,4,8,and 12-hour post dose|All participant received all treatments and is, therefore, included in the analysis population for all groups.|||ng*hr/dL||Inter-Quartile Range|Geometric Mean
2755062|NCT00842712|Secondary|Randomized Part: Time to Treatment Failure|Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC).|Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2755063|NCT00842712|Secondary|Randomized Part: Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
2755064|NCT00842712|Secondary|Randomized Part: Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2755065|NCT00842712|Secondary|Randomized Part: Progression Free Survival (PFS) Time - Investigator Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2755066|NCT00842712|Primary|Randomized Part: Progression Free Survival (PFS) Time - Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2755067|NCT00842712|Primary|Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)||Up to Week 3|DLT population included all participants who completed first 3 weeks of treatment (first chemotherapy cycle) or who discontinued treatment due to any DLT during the first 3 weeks of treatment in the safety-run-in part.|||participants|||Number
2755068|NCT00842608|Secondary|Mortality||ICU, in-hospital, 30-days post hospitalization||||Participants|||Count of Participants
2755074|NCT00842530|Other Pre-specified|Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo|Clinical signs and symptoms for VCD included the following: fever, clinical syndrome and hospitalization. Duration of each symptom (in days) is reported in this outcome measure.|Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months)|Analysis was performed on Safety Analysis Set. Here, ‘overall number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||Days||Standard Deviation|Mean
2755075|NCT00842530|Other Pre-specified|Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature >= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. VCD cases confirmed only by NS1 method were classified in the Not Identified category. Cases were defined as the number of participants with at least one symptomatic VCD episode more than 28 days after Inj. 3 (during the Active Phase).|After 28 days Post Inj. 3 up to the end of Active Phase (up to 25 months)|Analysis was performed on Other Efficacy Analysis Set 1.|||Participants|||Count of Participants
2755076|NCT00842530|Other Pre-specified|Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature >=37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.|Day 0 (Post-Inj.) up to end of Active phase (up to 25 months); 28 days post-Inj. 1 up to end of Active phase (up to 25 months)|Analysis was performed on Other Efficacy Analysis Set 1 which included participants who received at least the first injection.|||Cases|||Number
2755077|NCT00842530|Secondary|Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo|Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: >=37.5°C to <=38.0°C, Grade 2: >38.0°C to <=39.0°C, Grade 3: >39.0°C. Headache, malaise, myalgia and asthenia: - Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.|14 days post-any Inj. and each of the 3 Inj.|Analysis was performed on Reactogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||Percentage of participants|||Number
2755078|NCT00842530|Secondary|Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo|Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain: - Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: - Grade 1: > 0.0 to < 2.5 cm, Grade 2: >= 2.5 to < 5 cm, Grade 3: >= 5 cm.|7 days post-any Inj. and each of the 3 Inj.|Analysis was performed in the Reactogenicity Analysis Set, which included all participants who received at least one injection and were considered evaluable for reactogenicity. Here, 'number analyzed' = participants with available data for each specified category.|||Percentage of participants|||Number
2755079|NCT00842530|Secondary|GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo|GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue non-immune participants were defined as participants with titers < 10 (1/dilution) against all four dengue serotypes at baseline.|Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3|Analysis was performed on Full Analysis Set for Immunogenicity. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2755080|NCT00842530|Secondary|GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo|GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue immune participants were defined as those participants with titers >= 10 (1/dilution) against at least one dengue serotype at baseline.|Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3|Analysis was performed on Full Analysis Set for Immunogenicity. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2755081|NCT00842530|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo|GMT of antibodies against each serotype with the parental dengue virus strain were assessed by the plaque reduction neutralization test (PRNT).|Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3|Analysis was performed on Full Analysis Set for Immunogenicity defined as the participants included in the subgroup for Immunogenicity assessment who have received at least one dose and who had a blood sample drawn after vaccination. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2755092|NCT00842348|Secondary|Progression Free Survival (PFS): Kaplan-Meier Estimate|"The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.~Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method."|Throughout the study (every 24 weeks and at completion/withdrawal visit)|Intention-to-treat (ITT) population: all patients randomised in the original protocol Study 726 (regardless of whether they continued into the extension Study 729). The ITT population was analysed using patients as randomised in Study 726.|||weeks||95% Confidence Interval|Median
2755082|NCT00842530|Secondary|Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature >= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by dengue reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.|28 days Post-Inj. 2 up to Inj. 3, 28 days Post-Inj. 2 up to end of Active Phase ( up to 25 months)|Analysis was performed on Other Efficacy Analysis Set 2 which included all participants who received at least the two first injections.|||Cases|||Number
2755083|NCT00842530|Secondary|Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo|The severity of VCD cases was assessed by WHO 1999 severity assessment and IDMC clinical assessment. Dengue Hemorrhagic Fever (DHF) Grade I, II, III, and IV : Clinical Manifestations: a) Fever: acute onset, high and continuous, lasting 2-7 days, b) Any of hemorrhagic manifestations: petechiae, purpura, ecchymosis, epistaxis, gum bleeding, and hematemesis and/or melena, c) thrombocytopenia (platelet count=100 000/mm3 or less) d) Plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion and/or hypoalbuminemia. IDMC severity criteria: 1) Thrombocytopenia: platelet count <= 50 000/mm^3; 2) Hemorrhage that needs blood transfusion; 3) Objective evidence of capillary permeability 4) Signs of circulatory failure; 5) Visceral Manifestations. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.|28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months)|Analysis was performed on PPA set for efficacy.|||Cases|||Number
2755084|NCT00842530|Primary|Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature >= 37.5 degree Celsius (°C) measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue non-structural protein-1 (NS1) enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.|28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months)|Analysis was performed on Per-protocol analysis (PPA) set for efficacy which included participants with no protocol deviations. Participants with following protocol deviations were excluded: inclusion criteria not met or exclusion criteria met, randomization error, Inj. not performed, code breaking and delay between the inj. not respected.|||Cases|||Number
2755085|NCT00842361|Secondary|Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6.|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
2755086|NCT00842361|Secondary|Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
2755087|NCT00842361|Secondary|Electrocardiogram (ECG) Worsening|The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||participants|||Number
2755088|NCT00842361|Secondary|Change in Body Weight|Change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
2755089|NCT00842361|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2755090|NCT00842361|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
2755091|NCT00842361|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
2755107|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|12 months|Only 280 subjects (350 limbs) completed the 12 Month follow-up visit to provide data to this outcome measure.|||limbs|limbs||Count of Units
2755093|NCT00842348|Primary|Adverse Events|"Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.~An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:~It was not present prior to receiving the first dose of study treatment in Study 729; or,~It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.~Adverse event data are presented in the AE section."|Throughout the study until the completion/early discontinuation visit.|Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.|||participants with any TEAEs|||Number
2755094|NCT00842335|Secondary|Days to Progression|Progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions|Up to 112 days (four 28-day cycles) or longer if the patient is benefiting from treatment|The efficacy analyses were performed using all patients, who had at least one post-treatment evaluation for tumor assessment (N=17). The overall response was based on the number of cycles of treatment before the participant experienced progressive disease.|||days||Full Range|Median
2755095|NCT00842335|Secondary|Overall Clinical Response by Cycle|"Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.~Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions"|Up to 112 days ( four 28-day cycles)|All 18 participants were analyzed.|||participants|||Number
2755096|NCT00842335|Secondary|Number of Participants Reaching Maximum Tolerated Dose|Number of participants withdrawn from study due to adverse events|Up to 112 days (up to four 28-day cycles) or longer if the patient is benefiting from treatment|Only one subject withdrew due to an adverse event.|||participants|||Number
2755097|NCT00842335|Primary|Maximum Tolerated Dose (MTD) of JI-101|"The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors.~The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD.~Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacceptable treatment-related toxicity was defined as a clinically significant AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and that was attributed to JI 101."|28 days (1 cycle)|"Full Analysis Population (FAS) or Modified Intent-to-Treat (mITT) Population: All patients enrolled into the study who received JI-101 and completed at least 21 days of dosing in Cycle 1 comprised the FAS.~Safety Population: Included all patients who received at least one dose of study drug. This population was used for all safety analyses."|||mg|||Number
2755098|NCT00842309|Primary|Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)|The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.|Mid-treatment (week 6)||||units on a scale||Standard Deviation|Mean
2755099|NCT00842309|Primary|Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)|The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.|Endpoint (post-treatment, week 11)|BDD-YBOCS was a clinician-administered measure administered to patients with body dysmorphic disorder.|||units on a scale||Standard Deviation|Mean
2755100|NCT00842296|Secondary|Presence of Complications From GSV Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|5 years||||limbs|limbs||Count of Units
2755101|NCT00842296|Secondary|Presence of Complications From GSV Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|12 months||||limbs|limbs||Count of Units
2755102|NCT00842296|Secondary|Presence of Complications From GSV Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|3 Months||||limbs|limbs||Count of Units
2755103|NCT00842296|Secondary|Presence of Complications From Greater Saphenous Vein (GSV) Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|1 Week||||limbs|limbs||Count of Units
2755104|NCT00842296|Secondary|Visual Analog Pain Scale (VAS)|Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain|5 years||||units on a scale (0-10)|limbs|Standard Deviation|Mean
2755105|NCT00842296|Secondary|Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up|"Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0).~Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12."|Baseline thru 5 years||||VCSS Score|limbs|Standard Deviation|Mean
2755106|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|5 years|Only 221 subjects (279 limbs) completed the 5 Year follow-up visit to provide data to this outcome measure.|||limbs|limbs||Count of Units
2755110|NCT00842296|Secondary|CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification|"Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration~Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The CEAP classification. Mayo Clinic Proc 1996;71:338-45."|Baseline||||limbs|limbs||Count of Units
2755111|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|5 years|279 limbs were evaluated at the 5Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755112|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|4 years|275 limbs were evaluated at the 4Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755113|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|3 years|293 limbs were evaluated at the 3Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755114|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|2 years|329 limbs were evaluated at the 2Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755115|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|12 months|350 limbs were evaluated at the 12M timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755116|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|6 months|363 limbs were evaluated at the 6M timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755117|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|5 years|279 limbs were evaluated at the 5Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755118|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|4 years|275 limbs were evaluated at the 4Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
2755119|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|3 years|293 limbs were evaluated at the 3Y timepoint|||percentage of limbs|limbs|Standard Error|Mean
2755120|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.|2 years|Out of the limbs treated 329 limbs were available for a Duplex Ultrasound scan at the 2Y follow-up|||percentage of limbs|limbs|Standard Error|Mean
2755121|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|12 months|350 limbs were evaluated at the 12M timepoint|||percentage of limbs|limbs|Standard Error|Mean
2755122|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure.|6 Months|363 limbs were available for primary outcome measure evaluation at the 6M timepoint.|||percentage of limbs|limbs|Standard Error|Mean
2755123|NCT00842257|Secondary|Disease Control Rate as Defined by RECIST Criteria|Disease Control Rate as defined by RECIST criteria. The number patients achieving stable disease, partial response, or complete response at some point during follow-up.|3 years|One patient withdrawn for an infusion reaction prior to first re-staging CT scans.|||Participants|||Count of Participants
2755124|NCT00842257|Secondary|Median Overall Survival|The duration of time from start of treatment to time of death or otherwise the date of last tumor assessment. Median survival was calculated using Kaplan Meier suvival analysis.|3 years||||Months||Full Range|Median
2755125|NCT00842257|Secondary|Median Progression Free Survival (PFS)|The duration of time from start of treatment to time of radiologic disease progression per RECIST or death, or otherwise the date of last tumor assessment. Median PFS was calculated using Kaplan Meier suvival analysis. Progressive disease is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3 years|One patient withdrawn due to an infusion reaction prior to first re-staging CT scans.|||Months||Full Range|Median
2755157|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755126|NCT00842257|Primary|Response Rate of Single Agent Panitumumab Among Patients With KRAS Wild-type Colorectal Cancer Previously Treated With Cetuximab.|"The response rate of single agent panitumumab among patients with KRAS wild-type (Kirsten rat sarcoma viral oncogene homolog) colorectal cancer previously treated with cetuximab. Inclusive of three patients with clinical progression prior to first re-staging CT scans. Response rate evaluated using RECIST (Response Evaluation Criteria In Solid Tumors). Best overall response is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).~RECIST:~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions"|3 years|One patient withdrawn for an infusion reaction prior to first re-staging CT scans.|||Participants|||Count of Participants
2755127|NCT00842244|Secondary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was a>=20% increase in sum of the longest dimensions of target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.|||months||95% Confidence Interval|Median
2755128|NCT00842244|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR = disappearance of all target lesions. PR = at least 30% decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Analysis set included a subset of efficacy analysis set who had confirmed objective tumor response.|||months||95% Confidence Interval|Median
2755129|NCT00842244|Secondary|Percentage of Participants With Objective Response (OR)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent (%) decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.|||percentage of participants||95% Confidence Interval|Number
2755130|NCT00842244|Secondary|Drug Metabolizing Enzyme Genotyping|Genetic variants of uridine diphosphate (UDP)- glucuronosyl transferase 1A1 (UGT1A1) gene which were assessed for genotyping included UGT1A1*60, UGT1A1-3156, UGT1A1 Promoter thymine adenine (TA) repeat (UGT1A1*28, UGT1A1*36, UGT1A1*37), UGT1A1*6 and UGT1A1*27.|Day 1 of Cycle 1|Results are not reported because data was reported in individual participant listing but not statistically summarized for the analysis.||||||
2755131|NCT00842244|Secondary|Volume of Distribution (Vz) for Cisplatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter||95% Confidence Interval|Geometric Mean
2755132|NCT00842244|Secondary|Apparent Volume of Distribution (Vz/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Vz/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because Vz/F could not be accurately estimated.|||Liter||95% Confidence Interval|Geometric Mean
2755133|NCT00842244|Secondary|Clearance (CL) for Cisplatin|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of blood from which drug can be completely removed per unit of time. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter/hr||95% Confidence Interval|Geometric Mean
2755134|NCT00842244|Secondary|Apparent Oral Clearance (CL/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. CL/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because CL/F could not be accurately estimated.|||Liter/hr||95% Confidence Interval|Geometric Mean
2755135|NCT00842244|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Plasma decay half life for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine's metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||hrs||Standard Deviation|Mean
2755136|NCT00842244|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. AUC (0 - ∞) for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine's metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2755137|NCT00842244|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours. AUC (0-24) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Results for axitinib were normalized to axitinib 5 mg dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2755138|NCT00842244|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine's metabolites (5-FU, 5-DFUR, 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram*hour/milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
2755139|NCT00842244|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Tmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Tmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine's metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||hrs||Full Range|Median
2755203|NCT00841672|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues|||mm Hg||Standard Error|Least Squares Mean
2755140|NCT00842244|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Cmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Cmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine's metabolites (5-fluorouracil [5-FU], 5-deoxy-5-fluorouridine [5-DFUR] and 5-deoxy-5-fluorocytidine [5-DFC]) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on Cycle 1 (C1) Day -1 (D-1), C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||nanogram/milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2755141|NCT00842244|Other Pre-specified|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine|MTD = highest dose at which no more than 30 percent (%) of 12 participants experience DLT during Cycle 1. DLT = GR2 proteinuria; GR3 NHT (excluding alopecia and those that can be controlled with appropriate treatment)for >=7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile NP/NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment-related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.|||mg|||Number
2755142|NCT00842244|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|DLT = Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (>=)7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.|||participants|||Number
2755143|NCT00842231|Primary|Reading Acuity and Speed|Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.|||words per minute||95% Confidence Interval|Least Squares Mean
2755144|NCT00842231|Primary|Contrast Sensitivity|Contrast Sensitivity (CS) differences between subjects tested with full correction & spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) & mesopic conditions (with & without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.|||Logrithmic Units||Standard Deviation|Mean
2755145|NCT00842231|Primary|High and Low Contrast Acuity|"Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision)."|Day of study visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.|||logMAR||Standard Deviation|Mean
2755146|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 4|ITT Population||||||
2755147|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)|"Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100."|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||Percent change in scores on a scale||Standard Deviation|Mean
2755204|NCT00841672|Primary|Mean Sitting Systolic Blood Pressure (msSBP)|Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues|||mm Hg||Standard Error|Least Squares Mean
2755148|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit.|||participants|||Number
2755149|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit.|||participants|||Number
2755150|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit.|||participants|||Number
2755151|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit.|||participants|||Number
2755152|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Baseline (Week 0) and Week 4|ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||participants|||Number
2755153|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Week 1 and Week 4|ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||participants|||Number
2755154|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 2|ITT Population||||||
2755155|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)|"Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with 0=None and the right side anchored with 10=Very Severe. A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100."|Baseline (Week 0) and Week 2|ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit.|||Percent change in scores on a scale||Standard Deviation|Mean
2755156|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755158|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Week 2|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755159|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Week 2|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755160|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755161|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755162|NCT00842153|Primary|Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.|||participants|||Number
2755163|NCT00842075|Secondary|Weight Change After 28 Days Intervention Period|Mean weight change after 28 days intervention period|28 days||||kg||Standard Deviation|Mean
2755164|NCT00842075|Primary|HbA1c Value After 28 Days|HbA1c values 28 days after randomization|28|pilot study|||HbA1c %||Standard Deviation|Mean
2755165|NCT00842023|Other Pre-specified|Serum Levels of Cystatin-C|Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.|Baseline, 24 hours, 48 hours|Only participants with available data were assessed for this outcome measure.|||ng/mL||Standard Deviation|Mean
2755166|NCT00842023|Other Pre-specified|Inflammatory Markers|Interleukin-6|48 hours|Only participants with available data were assessed for this outcome measure.|||pg/mL||Standard Error|Mean
2755167|NCT00842023|Primary|Renal Function by Serum Creatinine|Serum creatinine values and changes in serum creatinine|Baseline, 24 hours, 48 hours||||mg/dL||Standard Deviation|Mean
2755168|NCT00841971|Secondary|Need for Additional Antifungal Therapy||90 days post enrollment||||participants|||Number
2755169|NCT00841971|Primary|Frequency of Fungal Infection||90 days post enrollment||||participants|||Number
2755170|NCT00841906|Secondary|The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.|"The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of good quality data needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician."|Lab Night|3 participants were not able to provide usable GSI data.|||percentage of average GSI||Standard Deviation|Mean
2755171|NCT00841906|Primary|This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.|This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.|Lab Night|All participants that completed the overnight portion of the study were analyzed.|||minutes||Standard Deviation|Mean
2755172|NCT00841906|Primary|This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.|"The central apnea index, hypopnea index, mixed apnea index and obstructive apnea indexes are all values that are calculated by determining the type of apneic event (apnea, hypopnea, mixed or obstructive). Each type of event is added up over the night and divided by the number of hours.~For this analysis each index was compared between both devices."|Lab Night|All participants that completed the overnight portion of the study were analyzed.|||events/hour||Standard Deviation|Mean
2755173|NCT00841906|Primary|This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.|The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx.|Lab Night|All participants that completed the overnight portion of the study were analyzed, they each had an Alice 5 System night and an Alice PDx night.|||events||Standard Deviation|Mean
2755174|NCT00841828|Secondary|Overall Clinical Response Rate (ORR)|"Overall clinical response was evaluated according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria (Therasse et al, 2000). Is defined as the sum of Complete responses plus Partial responses.~It was evaluated after the fourth EC cycle and before surgery using ultrasound, mammography, or MRI."|Up to 12 weeks|"Arm 1: 1 patient not included in this analysis due to negative Fluorescence in situ hybridization (FISH) result.~Arm 2: 2 patients not included in this analysis due to negative Fluorescence in situ hybridization (FISH) result."|||percentage of participants||95% Confidence Interval|Number
2755175|NCT00841828|Primary|Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).|Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.|Up to 16 weeks|"Arm 1: 1 patient not included in this analysis due to negative Fluorescence in situ hybridization (FISH) result.~Arm 2: 2 patients not included in this analysis due to negative Fluorescence in situ hybridization (FISH) result."|||percentage of participants with pCR||95% Confidence Interval|Number
2755176|NCT00841815|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2755177|NCT00841815|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2755178|NCT00841815|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755179|NCT00841776|Secondary|Median Change in Noninflammaotry Acne Counts|Median Change in Noninflammaotry Acne Counts|Baseline, Weeks 2, 4, 8, 12, and 16||||Noninflammatory lesion counts||Inter-Quartile Range|Median
2755180|NCT00841776|Secondary|Median Change in Inflammatory Acne Lesion Counts|Median Change in Inflammatory Acne Lesion Counts|Baseline, Weeks 2, 4, 8, 12, and 16|ITT|||Lesion Counts||Inter-Quartile Range|Median
2755181|NCT00841776|Secondary|Median Change in Total Acne Lesions|Median Change in Total Acne Lesions|Baseline, Weeks 2, 4, 8, 12, and 16|ITT|||Total Acne Lesion Counts||Inter-Quartile Range|Median
2755182|NCT00841776|Secondary|Median Change in Erythromycin-resistant P. Acne Counts|Total colony forming units of erythromycin-resistant p. acnes.|Baseline, Weeks 2, 4, 8, 12, and 16|ITT|||Erythromycin-resistant P. acne counts||Inter-Quartile Range|Median
2755183|NCT00841776|Secondary|Median Change in Clindamycin Resistant P. Acne.|Median change in total colony forming units of clindamycin resistant p. acne.|Baseline, Weeks 2, 4, 8, 12, 16|ITT|||Clindamycin- resistant P. acne counts||Inter-Quartile Range|Median
2755184|NCT00841776|Primary|Median Change in Total Propionibacterium Acne (P.Acne) Counts|Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.|Baseline, Weeks 2, 4, 8, 12, & 16||||P. acne counts||Inter-Quartile Range|Median
2755185|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titers from baseline as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis Set population.|||Percentages of participants||95% Confidence Interval|Number
2755186|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2 as determined by HI, MN and SRH assays.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.|||Percentages of participants||95% Confidence Interval|Number
2755187|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 Vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Ratios (GMRs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI,MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis set population.|||Ratios||95% Confidence Interval|Geometric Mean
2755188|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|"To evaluate the immunogenicity of two doses of MF59-eH5N1, each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Areas (GMAs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis Set population.|||Areas (mm^2)||95% Confidence Interval|Geometric Mean
2755189|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Titers (GMTs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.|||Titers||95% Confidence Interval|Geometric Mean
2755190|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titer from baseline, as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22 and day 64/day22)|This analysis was performed on the Full Analysis Set population|||Percentages of participants||95% Confidence Interval|Number
2755191|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain)|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2, as determined by HI, MN and SRH assays.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Percentages of participants||95% Confidence Interval|Number
2755192|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Ratio(GMRs) against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22, day 64/day43)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Ratios||95% Confidence Interval|Geometric Mean
2755193|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Monovalent Influenza Virus Vaccine (aH5N1)|"To evaluate the immunogenicity of two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1), in terms of Geometric Mean Areas (GMAs) as determined by Single Radial Haemolysis(SRH) assay.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Areas (mm^2)||95% Confidence Interval|Geometric Mean
2755194|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Titers(GMTs) against the homologous A/Vietnam/1194/2004 strain, as determined by hemagglutination Inhibition(HI) assay and Microneutralization(MN) assay.|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Titers||95% Confidence Interval|Geometric Mean
2755195|NCT00841763|Secondary|The Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine|To evaluate the safety and tolerability profile of two dose of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV), in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety set population|||Participants|||Number
2755196|NCT00841763|Primary|Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine|To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) pandemic influenza vaccine (MF59-eH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety Set population|||Participants|||Number
2755197|NCT00841698|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755198|NCT00841698|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755199|NCT00841698|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755200|NCT00841672|Secondary|Blood Pressure Control|Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study|End of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues|||Percentage of participants|||Number
2755201|NCT00841672|Secondary|Diastolic Blood Pressure Response|Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues All randomized patients who received the study medication. The measurement at Week 8 was used unless it was not available, in which case, the last observation carried forward was used.|||Percentage of participants|||Number
2755202|NCT00841672|Secondary|Systolic Blood Pressure Response|Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to GCP issues|||Percentage of participants|||Number
2755208|NCT00841568|Primary|Renal Function Test (eGFR)|"Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period.~Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded."|Baseline, Week 24, 48, 104, and 156||||mL/min/1.73m2||Inter-Quartile Range|Median
2755209|NCT00841568|Primary|Total Kidney Volume|"Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.~Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded."|Baseline, week 24, 52, 104, and 156||||mL||Inter-Quartile Range|Median
2755210|NCT00841555|Secondary|Time Spent in a Karnofsky Performance Status of 60-100%|Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS ≥70. The KPS higher scores indicates normal activity status.|up to 12-16 months|Kaplan-Meier analysis for time spent in a Karnofsky performance status (KPS) ≥70|||months||95% Confidence Interval|Median
2755211|NCT00841555|Secondary|Survival Time|All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient's physician deems it in the patient's interest not to continue or upon patient request.|up to 2 years||||months||95% Confidence Interval|Median
2755212|NCT00841555|Secondary|Time to Neuroradiological Evidence of Tumor Recurrence or Progression|As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect.|up to 12-16 months|||||||
2755213|NCT00841555|Primary|Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)|This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.|up to 12-16 months||||mg/m^2|||Number
2755214|NCT00841542|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755215|NCT00841542|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755216|NCT00841542|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755217|NCT00841412|Primary|Quality of Feeding Assistance Care Processes|"Research staff observed each participant during six meals per study phase. Research staff documented the total amount of staff time spent providing feeding assistance and each type of assistance per resident per meal. These data were used to construct standardized feeding assistance care quality indicators wherein the number of resident meal observations was variable. For example, one indicator was defined as: Percentage of meals during which resident intake was below 50% and staff offered and alternative to the served meal. Thus, the denominator for total number of observed meals scored varied by indicator. There were multiple indicators; thus, there is inadequate space to provide an adequate description of each measure and the corresponding scoring rules here. Please refer to published papers for a complete description of all outcome measures."|3 month intervention and 3 month follow up periods|Each participants was observed during six scheduled meals per person per study phase. A total of 130 participants completed all study phases and had complete data for analyses.|||percentage of meal observations|Participants||Number
2755218|NCT00841321|Secondary|Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.|"The Perceived Deficits Questionnaire (PDQ), a standardized questionnaire in which the subject reports on his or her cognitive function; Measure total score Range (0 best - 80 worse) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), in which the family member who was most aware of the participant's cognitive deficits reports on the subject's cognitive deficits; measure total score range (0 best - 60 worse) 'and the Community Integration Questionnaire (CIQ) in which the subject reports his or her degree of social integration; range (0 worst - 32 best); measure total score.~Sub-scales for these 3 measures were not used for outcome measures only total scores."|12 weeks||||units on a scale||Standard Deviation|Mean
2755219|NCT00841321|Primary|Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.|"Performance at exit adjusted for baseline performance on 4 neuropsychological tests:~STROOP(Victoria version):Tests attention&executive function. Outcome is the interference condition condition; time needed to name the colors in which words (which are names of colors) are printed. Words and colors are mismatched.~CaliforniaVerbalLearningTest- II: Tests verbal/learning/memory. Outcome number of words (shopping list) remembered after 20 min delay with no cues.~PacedAuditorySerialAdditionTest:Tests working memory/sustained attention. Outcome is the number of correct responses to recording giving numbers every 2 sec. Last 2 numbers must be added together before the next number.~ControlledOralWordAssociationTest:Tests letter fluency. Outcome number of words produced in one minute for each of 3 letters.~Measures reported as Z-scores based on the available population norms for each test; range -infinite +infinite; 0 average; -1=1std below average; +1=1std above average."|12 weeks|Data of all 120 participants was analyzed. For subjects with missing exit values (1 placebo, 2 ginkgo) the baseline measures were carried forward in the analysis.|||z-scores||Standard Deviation|Mean
2755220|NCT00841269|Secondary|A Secondary Outcome Measure Includes a Change in Young Mania Rating Scale (YMRS) Score|The Young Mania Rating Scale (YMRS) is an 11-item rating scale that evaluates manic symptoms. Total scores range from 0-60, with higher scores indicating more manic symptoms endorsed by research participants.|6 weeks||||units on a scale||Full Range|Mean
2755221|NCT00841269|Primary|The Primary Neuroimaging Outcome Will be Changes in Beta-NTP to TP (Total Phosphorus) Ratio in the Anterior Cingulate.||6 weeks||||Beta-NTP/TP Ratio||Standard Deviation|Mean
2755222|NCT00841269|Primary|Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment|The CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.|6 weeks||||Units on a scale||Full Range|Mean
2755223|NCT00841204|Secondary|Association Between Plasma and Target Tissue Sulindac Sulfide Levels||8 weeks|The correlation between plasma and target tissue sulindac sulfide levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.|||correlation coefficient|||Number
2755224|NCT00841204|Secondary|Association Between Plasma and Target Tissue Sulindac Sulfone Levels||8 weeks|The correlation between plasma and target tissue sulindac sulfone levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.|||correlation coefficient|||Number
2755225|NCT00841204|Secondary|Association Between Plasma and Target Tissue Sulindac Levels||8 weeks|The correlation between plasma and target tissue sulindac levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.|||correlation coefficient|||Number
2755226|NCT00841204|Secondary|Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi|Change in VEGF expression in melanocytic junctional component|Baseline and 8 weeks||||% of stained cells * intensity score||Inter-Quartile Range|Median
2755227|NCT00841204|Secondary|Sulindac Effects on Apoptosis in Atypical Nevi|Change in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component|Baseline and 8 weeks||||% of stained cells * intensity score||Inter-Quartile Range|Median
2755228|NCT00841204|Primary|Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis|||µg/g tissue||Standard Deviation|Mean
2755229|NCT00841204|Primary|Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis|||µg/g tissue||Standard Deviation|Mean
2755230|NCT00841204|Primary|Sulindac Concentration in the Nevi (Moles)||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis|||µg/g tissue||Standard Deviation|Mean
2755231|NCT00841100|Primary|Percent Change in Blood Phenylalanine|Percent change in phenylalanine in (uM) on Kuvan Response evaluated via fasting morning blood serum. A decrease of 30% or greater indicates positive response on Kuvan.|Baseline to Day 1 of the Acute Phase, Baseline to Day 28 of Phase 1, Baseline to Day 28 of Phase 3|3 participants from the acute phase elected not to continue to the Phase 1 component of the study. Participants who were non-responsive on the Phase 1 component of the study continued on to Phase 2. Participants who achieved a fasting blood phenylalanine of <600 umol/l can in Phase 2, continued to Phase 3.|||Percent change in blood phenylalanine||Standard Deviation|Mean
2755232|NCT00841087|Secondary|Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
2755233|NCT00841087|Secondary|Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
2755234|NCT00841087|Secondary|Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||participants|||Number
2755235|NCT00841087|Secondary|Change in Body Weight|Observed change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||kg||Standard Deviation|Mean
2755236|NCT00841087|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2755237|NCT00841087|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00−05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
2755255|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755238|NCT00841087|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
2755239|NCT00841035|Primary|Epidermal Growth Factor Receptor Signaling(EGFR) in the Presence of Pancreatic Tumor Related to the Mechanism to Erlotinib.|It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.|During the trial only|||||||
2755240|NCT00841035|Secondary|The Secondary Objectives Include Analysis of Recurrence-free and Overall Survival and the Development of a Predictive Assay for Response to Erlotinib Based on Selected Bio-markers in Endoscopic Ultrasound-Fine-needle Aspiration Specimens.|The measurement was to be the average length of time before recurrence of disease and the overall survival time. As well as time from recurrence to death in subjects.This time will be measure in months till recurrence and them months to death.|End of the study|Due to the closure of the study before this endpoint could be met, there are no subjects analyzed.||||||
2755241|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|90 days post operative|Include the participants who finished the Acute SF 12 health survey at 90 days follow-up|||units on a scale||Inter-Quartile Range|Median
2755242|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|30 days post operative|Include the participants who finished the Acute SF 12 health survey at 30 days follow-up|||units on a scale||Inter-Quartile Range|Median
2755243|NCT00840996|Secondary|Duration of Hospitalization|Length of hospital stay will be recorded in days.|At discharge|3 patients in the placebo group did not have duration of hospital stay recorded.|||days||Inter-Quartile Range|Median
2755244|NCT00840996|Secondary|Postoperative Nausea and Vomiting (PONV)|Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.|post op day one and two or till hospital discharge|We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time|||participants|||Number
2755245|NCT00840996|Secondary|Number of Participants With Any Major 30-day Post Operative Complications|The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission.|30 days after surgery||||participants|||Number
2755246|NCT00840996|Primary|Opioid Medication Requirement, mg in IV Morphine Equivalent|Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents|through postoperative day 2 (or discharge, if earlier)||||mg IV morphine equivalent||Standard Deviation|Mean
2755247|NCT00840996|Primary|Mean Pain Scores|The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).|From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).||||verbal response scores||Standard Deviation|Mean
2755248|NCT00840879|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
2755249|NCT00840879|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
2755250|NCT00840879|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.|||µg/mL||Standard Deviation|Mean
2755251|NCT00840866|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755252|NCT00840866|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755253|NCT00840866|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755254|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/h/mL||Standard Deviation|Mean
2755256|NCT00840840|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755257|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755258|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755259|NCT00840840|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755260|NCT00840827|Secondary|Safety of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by Severity of Adverse Events.|Safety will be evaluated by the severity of each type of adverse event to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was never met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore safety could not be evaluated.||||||
2755261|NCT00840827|Secondary|Safety of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by Relatedness of Adverse Events to the Combination of Treatments.|Safety will be evaluated by the relatedness of each type of adverse event to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was never met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore safety could not be evaluated.||||||
2755262|NCT00840827|Secondary|Safety of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by Frequency of Adverse Events.|Safety will be evaluated by frequency of each type of adverse event to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was never met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore safety could not be evaluated.||||||
2755263|NCT00840827|Secondary|Tolerability of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by the Relatedness of Adverse Events.|Tolerability will be evaluated by the relatedness of adverse events to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was never met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore tolerability could not be evaluated.||||||
2755264|NCT00840827|Secondary|Tolerability of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by Severity of Adverse Events.|Tolerability will be evaluated by the severity of adverse events to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was never met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore tolerability could not be evaluated.||||||
2755265|NCT00840827|Primary|Efficacy of Lenalidomide in Combination With Cyclosporine A (CSA) to Achieve Red Cell Transfusion Independence in Subjects With Low- or Intermediate-1 Risk IPSS MDS Without a Del (5q31-33) Cytogenetic Abnormality by Hemoglobin Change.|Efficacy of lenalidomide + CSA will be evaluated as a function of change of hemoglobin concentration from baseline to 12 months.|Baseline and 12 months|6 patients were enrolled, the target enrollment was not met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore the change of hemoglobin concentration from baseline to 12 weeks could not be evaluated.||||||
2755266|NCT00840827|Primary|Efficacy of Lenalidomide in Combination With Cyclosporine A (CSA) to Achieve Red Cell Transfusion Independence in Subjects With Low- or Intermediate-1 Risk IPSS MDS Without a Del (5q31-33) Cytogenetic Abnormality.|Efficacy of lenalidomide + CSA will be evaluated as a function of red blood cell transfusion independence.|12 months|6 patients were enrolled, the target enrollment was not met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore red blood cell transfusion independence could not be evaluated.||||||
2755267|NCT00840827|Secondary|Tolerability of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by Frequency of Adverse Events.|Tolerability will be evaluated by the frequency of adverse events to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was never met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore tolerability could not be evaluated.||||||
2755268|NCT00840827|Secondary|Safety of Lenalidomide in Combination With CSA in Subjects With Low- or Intermediate-1 Risk MDS Without a Del (5q31-33) Cytogenetic Abnormality by Type of Adverse Events.|Safety will be evaluated by type of adverse events to lenalidomide in combination with CSA|12 months|6 patients were enrolled, the target enrollment was not met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 12 months of study treatment, therefore the type of adverse events to lenalidomide in combination with CSA, could not be evaluated.||||||
2755269|NCT00840827|Primary|Efficacy of Lenalidomide in Combination With Cyclosporine A (CSA) to Achieve Red Cell Transfusion Independence in Subjects With Low- or Intermediate-1 Risk IPSS MDS Without a Del (5q31-33) Cytogenetic Abnormality.|Efficacy of lenalidomide + CSA will be evaluated as a function of red blood cell transfusion needs improvement (≥ 50% decrease in RBC transfusion requirements after 16 weeks of study treatment).|16 weeks|6 patients were enrolled, the target enrollment was not met. Study was terminated by the PI and no statistical analysis was performed. None of the patients completed the 16 weeks of study treatment, therefore red blood cell transfusion could not be evaluated.||||||
2755304|NCT00840203|Secondary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects|||ng*h/mL||Standard Deviation|Mean
2755270|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the Mean Score of the Injection Risk Index (IRI).|"The injection risk index (IRI) was calculated by averaging the responses to the following five questions:~In the past month, how often have you used a needle or syringe that you knew or suspected had been used before by someone else?~In the past month, how often was a new syringe used to divide the drug?~In the past month, how often did you use a bottle-cap/spoon/cooker after someone else had used it?~In the past month, how often did you use a cotton filter for a needle after someone else had used it?~In the past month, how often did you use rinse water to clean needles after someone else had used it? The possible responses to the questions were coded as follows: 0=never, 1=sometimes, 2=about half the time, 3=often, 4=always. Before averaging the responses to the five questions, the responses to the second question were reversed coded to yield the same direction as the responses to the other four questions. IRI range: 0-20. Higher IRI-->higher risk."|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline|Analyses for the secondary outcomes were stratified by site. Of the total 292 participants in the Intervention Group, 142 were in Tijuana and 150 in Cd. Juarez. Similarly, of the 292 participants in the Control Group, 142 were in Tijuana and 150 in Cd Juarez.|||IRI Score||95% Confidence Interval|Mean
2755271|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the Proportional Odds of Higher Receptive Needle Sharing|"For a) we asked: In the past month, how often have you used a needle or syringe that you knew or suspected had been used before by someone else? (possible responses: 1=never, 2=sometimes, 3=about half the time, 4=often, 5=always), with a higher response indicating a higher risk. The intervention effect was evaluated by conducting ordinal logistic regression, with the frequency of receptive needle sharing as the outcome variable and Group (Intervention vs. Control), Visit (Baseline, 4-months, 8-months, and 12-months) and the interaction term between the two (Visit*Group) as the main effects. Our primary interest was the Visit*Group interaction, with a significant corresponding p-value being indicative of an intervention effect."|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline|Analyses for the secondary outcomes were stratified by site. Of the total 292 participants in the Intervention Group, 142 were in Tijuana and 150 in Cd. Juarez. Similarly, of the 292 participants in the Control Group, 142 were in Tijuana and 150 in Cd Juarez.|||Odds Receptive Needle Sharing||95% Confidence Interval|Mean
2755272|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the Mean Number of Unprotected Sex Acts With Clients.|The analytic method used for a) was negative binomial regression with the number of unprotected sex acts with clients as the outcome variable and intervention group, time point (baseline, 4-, 8-, and 12-months), and the interaction between the two as the main effects of interest.|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline|The data was analyzed by study location. In Tijuana, there were 284 participants (143 in the intervention and 141 in the control group) and in Ciudad Juarez there were 300 participants (151 in the intervention and 149 in the control group).|||Number of unprotected sex acts||Standard Deviation|Mean
2755273|NCT00840658|Primary|Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.|"Combined incidence for HIV/STI was calculated over the 12-month study period and included only those who a) had at least one follow-up visit and b) at baseline tested negative for HIV and any of the aforementioned STIs.~In the calculations we accounted for the time each participant spent at risk of HIV/any STI during the follow-up period, by using available information on each participant for each time point (i.e. baseline, 4-, 8-, and 12-months was used).~The analytic method used for this outcome analysis was Poisson regression with robust variance estimation. The outcome variable was a binary variable indicating whether a participant has contracted HIV or a new STI during the 12-month follow-up period. The primary factor of interest was the intervention group. The log (time spent at risk of HIV/any STI) was used as an offset variable in order to account for the time spent at risk of HIV/any STI by each participant."|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||||incidence density per 100 person years|||Number
2755274|NCT00840632|Secondary|AUC0-t - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period||||pg*h/mL||Standard Deviation|Mean
2755275|NCT00840632|Secondary|AUC0-inf - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period||||pg*h/mL||Standard Deviation|Mean
2755276|NCT00840632|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period||||pg/mL||Standard Deviation|Mean
2755277|NCT00840632|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg*h/mL||Standard Deviation|Mean
2755278|NCT00840632|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg*h/mL||Standard Deviation|Mean
2755279|NCT00840632|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg/mL||Standard Deviation|Mean
2755280|NCT00840476|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.|||µg*h/mL||Standard Deviation|Mean
2755281|NCT00840476|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.|||µg*h/mL||Standard Deviation|Mean
2755282|NCT00840476|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.|||µg/mL||Standard Deviation|Mean
2755305|NCT00840203|Secondary|Cmax - Maximum Observed Concentration|Cmax results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755283|NCT00840463|Secondary|Change in Short Form-36 Physical Functioning|Change between baseline and follow-up in the physical functioning items of the SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health|baseline 4 months|note that there was no change in the SF-36 score (baseline to month 4) for the placebo arm hence the mean is not meaningful|||score on a scale||Full Range|Mean
2755284|NCT00840463|Secondary|Change in Functional Class|Change in functional class from baseline to month 4. This is graded from WHO FC I to FC IV. Assessment will be completed by an investigator on the study at every visit.|basline and 4 months||||Participants|||Count of Participants
2755285|NCT00840463|Secondary|Change in 6 Minute Walk Distance|subjects complete the 6 minute walk test to determine how far (in meters) they are able to walk in 6 minutes.|Baseline and Four months||||meters||Full Range|Mean
2755286|NCT00840463|Primary|Safety Assessment-Number of Subjects Who Are Free and Those Who Developed Clinically Significant Adverse Events (CSAEs)|Freedom from clinically significant adverse events will be measure by determining the number free from CSAEs and those who developed CSAEs|4 months||||Participants|||Count of Participants
2755287|NCT00840463|Primary|Change in Pulmonary Vascular Resistance (Wood Units)|The primary efficacy outcome will be Pulmonary Vascular Resistance.PVR will be calculated as [(PA mean - wedge) / Cardiac Output]|Baseline and Four months||||wood units||Full Range|Mean
2755288|NCT00840450|Secondary|Progression-free-survival at 12 Months|This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.|up to 12 months|Based on intent-to-treat population.|||percentage of participants|||Number
2755289|NCT00840450|Secondary|Progression-free-tolerance|This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment.|12 weeks|Based on intent-to-treat population.|||percentage of participants|||Number
2755290|NCT00840450|Primary|the Best Overall Clinical Response|This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.|12 weeks|The analysis is based on the intent-to-treat population.|||percentage of participants|||Number
2755291|NCT00840411|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755292|NCT00840411|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|AUCinf could not be estimated for some subjects.|||ng*h/mL||Standard Deviation|Mean
2755293|NCT00840411|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755294|NCT00840307|Primary|Pancreatic and Liver Triglyceride (Fat) Content|Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).|months after the first band inflation||||percent||Inter-Quartile Range|Median
2755295|NCT00840294|Secondary|Overall Infectious Complication Rate Following Prostate Biopsy|To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy|Within 24 hours of biopsy|Subjects with complete data are included.|||percentage of participants||95% Confidence Interval|Number
2755296|NCT00840294|Primary|Change in PSA Level From Baseline|"To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization.~Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline)."|At baseline and 21-45 days after randomization|Subjects with complete data are included|||log ng/mL||Standard Deviation|Mean
2755297|NCT00840281|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.||||ng*h/mL||Standard Deviation|Mean
2755298|NCT00840281|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.||||ng*h/mL||Standard Deviation|Mean
2755299|NCT00840281|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755300|NCT00840216|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755301|NCT00840216|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755302|NCT00840216|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755303|NCT00840203|Secondary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|AUC0-t results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755306|NCT00840203|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755307|NCT00840203|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects|||ng*h/mL||Standard Deviation|Mean
2755308|NCT00840203|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755309|NCT00840177|Other Pre-specified|Relapse-free Survival (RFS)|"RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.~Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL."|RFS assessed for up to 5 years, median RFS reported|Eligible participants who started treatment|||months||95% Confidence Interval|Median
2755310|NCT00840177|Other Pre-specified|Overall Survival (OS)|OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored.|OS assessed for up to 5 years, median OS reported|Eligible participants who started treatment|||months||95% Confidence Interval|Median
2755311|NCT00840177|Other Pre-specified|Correlation Between Pre-study Cytogenetic Features and Response||5 years|||||||
2755312|NCT00840177|Secondary|Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0|Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event|Up to 5 years post registration|Eligible patients who were assessed for adverse events|||Participants|||Number
2755313|NCT00840177|Primary|Complete Remission (CR) Rate (Including CR With Incomplete Recovery)|"Participants who achieved morphological complete remission with or without incomplete blood count recovery.~Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL."|Up to 5 years after registration|Eligible participants who started treatment|||Participants|||Count of Participants
2755314|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755315|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755316|NCT00840099|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755317|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755318|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755319|NCT00840099|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755320|NCT00840086|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||events|||Number
2755321|NCT00840086|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.|The safety analysis set includes all 150 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 148 subjects had 50 exposure days (EDs).|||N with Inhibitors / N with ≥50 EDs|||Number
2755354|NCT00839930|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755322|NCT00840073|Secondary|AUC0-72 - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng*h/mL||Standard Deviation|Mean
2755323|NCT00840073|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng/mL||Standard Deviation|Mean
2755324|NCT00840073|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng*h/mL||Standard Deviation|Mean
2755325|NCT00840073|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all data from completed subjects could be used to determine AUC0-inf.|||ng*h/mL||Standard Deviation|Mean
2755326|NCT00840073|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng/mL||Standard Deviation|Mean
2755327|NCT00840060|Primary|Number of Verb Structures Per Utterance|Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.|Pre-treatment, post-treatment, 1-month follow-up||||Novel verb structures per utterance||Standard Deviation|Mean
2755328|NCT00840060|Primary|Language Sample Analysis|Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.|Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.|Language samples were collected for all children participating in either treatment condition.|||Percentage of utterances||Standard Deviation|Mean
2755329|NCT00840034|Other Pre-specified|Change From Baseline to 8 Weeks in Supine Pulse|Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and included all participants who have baseline and at least 1 post-baseline supine pulse rate measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2755330|NCT00840034|Other Pre-specified|Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure|Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who have baseline and at least 1 post-baseline supine systolic and diastolic blood pressure measure.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
2755331|NCT00840034|Secondary|Colombia-Suicide Severity Rating Scale (C-SSRS)|"Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline C-SSRS Score.|||percentage of participants|||Number
2755332|NCT00840034|Secondary|Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)|The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MGH-SFQ Score.|||units on a scale||Standard Error|Least Squares Mean
2755339|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)|CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CGI-Severity Score.|||units on a scale||Standard Error|Least Squares Mean
2755333|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; last observation carried forward. If ≤2 items are missing mean of all other items are imputed.|||percentage of the maximum possible score||Standard Error|Least Squares Mean
2755334|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)|The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline SDS Total Score; last observation carried forward. Missing work score imputed with average of other 2-item scores.|||units on a scale||Standard Error|Least Squares Mean
2755335|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)|VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 [complete disability (unable to do any activities)]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-P Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2755336|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)|VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 [complete disability (unable to do any activities)]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-F Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2755337|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)|The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline FAsD-PRO Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2755338|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CPFQ Total Score.|||units on a scale||Standard Error|Least Squares Mean
2755353|NCT00839930|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755355|NCT00839930|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755340|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)|HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for each subscale. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline HADS Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2755341|NCT00840034|Primary|Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MADRS Total Score.|||units on a scale||Standard Error|Least Squares Mean
2755342|NCT00840034|Secondary|Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items|QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Individual Score.|||units on a scale||Standard Error|Least Squares Mean
2755343|NCT00840034|Secondary|Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score|QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Total Score.|||units on a scale||Standard Error|Least Squares Mean
2755344|NCT00839982|Secondary|Overall Survival|Median overall survival|Up to 5 years||||median months||Full Range|Median
2755345|NCT00839982|Secondary|Disease Free Survival|Median disease-free survival|Up to 5 years||||median months||Full Range|Median
2755346|NCT00839982|Secondary|Treatment Response|CR = no evidence of leukemia with complete blood count recovery (ANC >1,000 and PLTS >100k) CRi = no evidence of leukemia but with incomplete blood count recovery|Up to 5 years||||Participants|||Count of Participants
2755347|NCT00839982|Primary|Maximum Tolerated Dose|We identified 20 mg/d for 5 d as the maximum tolerated dose (MTD) of oral clofarabine.|up to 5 years||||mg/day|||Number
2755348|NCT00839982|Primary|Number of Patients With Dose Limiting Toxicity|Dose limiting toxicity (DLT) consists of grade 3-4 non-hematologic toxicity at least possibly related to study drug. Exceptions include neutropenic fever; drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin recovering to < grade 2 by 7 days. Prolonged grade 2 myelosuppression lasting longer than 49 days in patients who don't proceed to additional cytotoxic therapy is considered a DLT. The MTD or recommended phase II dose is the highest dose level at which no more than 1 patient out of 6 experiences DLT.|Outcomes by day 30||||Participants|||Count of Participants
2755349|NCT00839956|Secondary|Median Follow-up Survival for All Patients||Up to 5 years||||years||Full Range|Median
2755350|NCT00839956|Secondary|Survival for All Patients||Up to 5 years||||Participants|||Count of Participants
2755351|NCT00839956|Secondary|Time to Disease Progression in Patients Who Progressed|Patients will be followed for initial response to therapy and for progression of disease. Response criteria will be scored according to International Myeloma Working Group uniform response criteria.|Up to 5 years|One subject withdrew from the study within first week of study therapy and changed to different therapy and is not included in this outcome measure.|||years||Full Range|Median
2755352|NCT00839956|Primary|Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|The first three months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. Rules for stopping the study will be based on the rate of withdrawal due to significant toxicity (grade IV, non-hematological, non-metabolic, nonperipheral neuropathy).|The first three months of therapy|No patients met stopping rules for significant toxicity in the first three months of therapy.|||Participants|||Count of Participants
2755357|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 5 days postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755358|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755359|NCT00839917|Other Pre-specified|Percentage of Participants With Any Systemic Adverse Experience|"An adverse experience is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences."|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755360|NCT00839917|Other Pre-specified|Percentage of Participants With Zoster-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755361|NCT00839917|Other Pre-specified|Percentage of Participants With Rubella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755362|NCT00839917|Other Pre-specified|Percentage of Participants With Varicella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755363|NCT00839917|Other Pre-specified|Percentage of Participants With Measles-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
2755364|NCT00839917|Secondary|Geometric Mean Titer of VZV (gpELISA) Antibodies|Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||gpELISA units/mL||90% Confidence Interval|Geometric Mean
2755365|NCT00839917|Secondary|Geometric Mean Titer of Rubella Antibodies|Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||IU/mL||90% Confidence Interval|Geometric Mean
2755366|NCT00839917|Secondary|Geometric Mean Titer of Mumps Antibodies|Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||Units/mL||90% Confidence Interval|Geometric Mean
2755367|NCT00839917|Secondary|Geometric Mean Titer of Measles Antibodies|Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||mIU/mL||90% Confidence Interval|Geometric Mean
2755368|NCT00839917|Primary|Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL|Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2755369|NCT00839917|Primary|Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL|Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2755370|NCT00839917|Primary|Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL|Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2755371|NCT00839917|Primary|Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL|Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2755372|NCT00839852|Secondary|Change From Baseline to Week 48 in the CGI-S Score|The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.|Baseline to Week 48|Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.|||Units on a scale||Standard Error|Mean
2755373|NCT00839852|Primary|Change From Baseline to Week 48 in the PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 48|Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.|||Units on a scale||Standard Error|Mean
2755374|NCT00839800|Secondary|Asthma Control Questionnaire (ACQ)|The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||units on a scale||Standard Deviation|Mean
2755375|NCT00839800|Secondary|Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)|An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of asthma-control days||Standard Deviation|Mean
2755376|NCT00839800|Secondary|Percentage of As-needed-free Days|An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of as-needed-free days||Standard Deviation|Mean
2755377|NCT00839800|Secondary|Symptom-free Days (no Symptoms and no Awakenings)|A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||symptom-free days||Standard Deviation|Mean
2755378|NCT00839800|Secondary|The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations|Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of participants|||Number
2755379|NCT00839800|Secondary|Nights With Awakening(s) Due to Asthma Symptoms|The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Nights With Awakening(s)||Standard Deviation|Mean
2755380|NCT00839800|Secondary|Asthma Symptom Score|The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||units on a scale||Standard Deviation|Mean
2755381|NCT00839800|Secondary|Use of As-needed Medication|The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||inhalations/day||Standard Deviation|Mean
2755382|NCT00839800|Secondary|Forced Expiratory Volume in One Second (FEV1)|The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Liter (L)||Standard Deviation|Geometric Mean
2755383|NCT00839800|Secondary|Evening PEF|The mean value from a 52-week treatment period.|2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||L/min||Standard Deviation|Mean
2755384|NCT00839800|Secondary|Morning Peak Expiratory Flow (PEF)|The mean value from a 52-week treatment period.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Liter/minute (L/min)||Standard Deviation|Mean
2755385|NCT00839800|Secondary|Number of Asthma Exacerbations|Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Asthma exacerbations|||Number
2755386|NCT00839800|Primary|The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study|Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.|week 52|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of participants|||Number
2755387|NCT00839540|Primary|Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).~These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M)."|Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug|Each subject received drug and had serum samples drawn at pre-treatment, 1.5h, 12h, and 24h after dosing.|||Log inhibition|Participants||Number
2755388|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 104 and Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).|||Kilograms||Standard Deviation|Mean
2755389|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
2755390|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
2755391|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Participants|||Number
2755392|NCT00839527|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population|||Weeks||95% Confidence Interval|Median
2755393|NCT00839527|Secondary|Change From Baseline in FPG at Week 104 and Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2755394|NCT00839527|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2755466|NCT00839098|Primary|Wheelchair Occupancy|Wheelchair occupancy was measured by the sum of duration that the seat of the wheelchair was occupied. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||hours||Standard Deviation|Mean
2755395|NCT00839527|Secondary|Change From Baseline in HbA1c at Week 104 and Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2755396|NCT00839527|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2755397|NCT00839436|Other Pre-specified|Change: CD4/CD8 T Cell Cts After CYT107; in Immunophenotype (Naive, Memory, Regulatory T Cell Subsets) & Amp; Antigen-specific T Cell Function After CYT107; in T Cell Activation/Proliferation Status & Amp; TCR Repertoire After CYT107; ...||48 weeks per patient with a 3-4 year enrollment period|||||||
2755398|NCT00839436|Primary|Adverse Events and Toxicities Associated With CYT107.||48 weeks per patient with a 3-4 year enrollment period||||Events|||Number
2755399|NCT00839423|Secondary|Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)||Week 6|FAS, LOCF|||percentage of patients|||Number
2755400|NCT00839423|Secondary|Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 6|FAS, LOCF|||percentage of patients|||Number
2755401|NCT00839423|Secondary|Change in Clinical Status Using CGI-I Score at Week 6|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
2755402|NCT00839423|Secondary|Change From Baseline in CGI-S Score After 6 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
2755403|NCT00839423|Secondary|Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
2755404|NCT00839423|Secondary|Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment|The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
2755405|NCT00839423|Secondary|Change From Baseline in MADRS Total Score After 1 Week of Treatment||Baseline and Week 1|FAS, LOCF. Please note that 1 patient in each Vortioxetine group did not have a valid MADRS assessment at Week 1, but were included in the analysis because they had a valid MADRS assessment after Week 1.|||units on a scale||Standard Error|Mean
2755406|NCT00839423|Primary|Change From Baseline in MADRS Total Score After 6 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF)|||units on a scale||Standard Error|Mean
2755407|NCT00839332|Secondary|Phase 2: Electrocardiogram QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Twelve-lead ECG data was used to calculate QTc based on Fridericia's formula (QTc=QT/RR^0.33, where RR is the interval between two R waves). For each participant, changes in QTc were calculated by subtracting the reading taken before LY2603618 administration from the reading taken after LY2603618 administration on Days 2 and 16 during Cycle 1. The number of participants in which the change in QTc was <=30 milliseconds (msec), >30-60 msec, or >60 msec is presented.|Phase 2: Days 2 and 16 of Cycle 1|Phase 2 participants who received at least 1 dose of LY2603618 and had evaluable ECG data.|||Participants|||Count of Participants
2756853|NCT00829673|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2755408|NCT00839332|Secondary|Phase 1: Electrocardiogram QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Twelve-lead electrocardiogram (ECG) data was used to calculate the corrected QT (QTc) based on Fridericia's formula (QTc=QT/RR^0.33, where RR is the interval between two R waves). For each participant, changes in QTc were calculated by subtracting the reading taken before LY2603618 administration from the reading taken after LY2603618 administration on Days 2 and 16 during Cycle 1. The number of participants in which the change in QTc was <=30 milliseconds (msec), >30-60 msec, or >60 msec is presented by dose group and overall.|Phase 1: Days 2 and 16 of Cycle 1|Phase 1 participants who received at least 1 dose of LY2603618 and had evaluable ECG data.|||Participants|||Count of Participants
2755409|NCT00839332|Secondary|Phase 2: Duration of Response|Duration of response was defined as the time from the first observation of complete response (CR) or partial response (PR) to the first observation of progressive disease or death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date and who do not have progressive disease, the duration was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent anticancer therapy (systemic, radiologic, or surgery). Participants were also censored at the last valid assessment prior to missing more than 1 consecutive scheduled assessment. Duration of response was summarized using Kaplan-Meier estimates.|Phase 2. Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who received at least 1 dose of study drug and had a confirmed response (CR or PR).|||months||95% Confidence Interval|Median
2755410|NCT00839332|Other Pre-specified|Number of Deaths During the Phase 1 Post-study Period|The number of participants who died during the post-study period of Phase 1 does not include the outcomes for the 4 participants who died while on treatment during Phase 2 as captured in the Participant Flow Table. A summary of serious and other non‐serious adverse events regardless of causality is located in the Reported Adverse Events module.|Phase 1: Time of last dose of study drug through the end of the follow-up period|Participants enrolled in Phase 1.|||Participants|||Count of Participants
2755411|NCT00839332|Secondary|Phase 2: Clinical Benefit Rate|Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1 guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Overall response rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Phase 2: Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2755412|NCT00839332|Secondary|Phase 2: Overall Response Rate|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Phase 2: Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2755413|NCT00839332|Secondary|Phase 2: Progression-free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.|Phase 2: Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who were randomized.|||months||95% Confidence Interval|Median
2755414|NCT00839332|Secondary|Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618|Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma AUC(0-24), AUC(0-tlast), and AUC(0-inf) values are reported for the 230 mg LY2603618 dose on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point.|Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.|Phase 2 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable calculation of the LY2603618 AUC.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2755425|NCT00839306|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT|||Percentage of Participants|||Number
2755426|NCT00839241|Secondary|Lymphocytes||Day 8 postop||||percentage of white blood cells||Standard Deviation|Mean
2755427|NCT00839241|Secondary|Lymphocytes||Day 5 postop||||percentage of white blood cells||Standard Deviation|Mean
2755428|NCT00839241|Secondary|Lymphocytes||Day 1 postop||||percentage of white blood cells||Standard Deviation|Mean
2755429|NCT00839241|Secondary|Lymphocytes||Baseline||||percentage of white blood cells||Standard Deviation|Mean
2755415|NCT00839332|Secondary|Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618|Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine plasma and dFdU concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only LY2603618 plasma AUC from time zero to 24 hours (AUC[0-24]), AUC from time zero to the last time point with a measurable concentration (AUC[0-tlast]), and AUC from time zero to infinity (AUC[0-inf]) values are reported for each LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point.|Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.|Phase 1 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable calculation of the LY2603618 AUC.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2755416|NCT00839332|Secondary|Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618|Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported at the 230 mg LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point.|Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.|Phase 2 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable determination of the LY2603618 Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2755417|NCT00839332|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618|Plasma samples for pharmacokinetic (PK) analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported for each LY2603618 dose level on Cycle (C) 1 /Day (D) 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point.|Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.|Phase 1 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable determination of the LY2603618 Cmax.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2755418|NCT00839332|Primary|Phase 2: Overall Survival (OS)|Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the cut-off date. OS was summarized using Kaplan-Meier estimates.|Phase 2: Baseline to date of death|Phase 2 participants who were randomized.|||months||95% Confidence Interval|Median
2755419|NCT00839332|Primary|Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine|The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after gemcitabine was based on the maximum tolerated dose and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity [AUC(0-inf)] >21,000 nanogram*hour/milliliter [ng*h/mL] and maximum LY2603618 plasma concentration [Cmax] >2000 nanograms/milliliter [ng/mL]).|Baseline through 18 months|Phase 1 participants who received at least 1 dose of study drug.|||milligrams (mg)|||Number
2755420|NCT00839319|Primary|Intratesticular Testosterone (ITT-T)||10 days||||IU/L||Inter-Quartile Range|Median
2755421|NCT00839319|Primary|Serum Follicle Stimulating Hormone (FSH)||10 days||||IU/L||Inter-Quartile Range|Median
2755422|NCT00839319|Primary|Serum Luteinizing Hormone (LH)||10 days||||IU/L||Inter-Quartile Range|Median
2755423|NCT00839319|Primary|Serum Testosterone (T)||10 days|Analysis per protocol. Due to nonnormality, the data were expressed as medians and 25th and 75 percentiles. Analysis of both baseline and end of treatment hormone concentrations performed on 31 subjects who completed all study procedures and who suppressed serum LH below the lower limit of normal at end of treatment.|||nmol/liter||Inter-Quartile Range|Median
2755424|NCT00839306|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2755430|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 8 postop||||10^3/uL||Standard Deviation|Mean
2755431|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 5 postop||||10^3/uL||Standard Deviation|Mean
2755432|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 1 postop||||10^3/uL||Standard Deviation|Mean
2755433|NCT00839241|Secondary|Leucocyte Particle Concentration||Baseline||||10^3/uL||Standard Deviation|Mean
2755467|NCT00839098|Primary|Power Wheelchair Usage|Power wheelchair usage was measured by the sum of distances that the power wheelchair traveled (km) divided by the duration of the wheelchair being occupied a day (hr). The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||km/hour||Standard Deviation|Mean
2755468|NCT00839098|Primary|Frequency of Power Seat Function Usage|Frequency of power seat function usage was measured by the number of times of changing tilt and recline angles averaged by the duration that the participant occupied the wheelchair per day. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||times/hour||Standard Deviation|Mean
2755469|NCT00839098|Secondary|Questionnaire Responses: Independence in Community|This outcome was measured in three aspects: Physical Independence, Cognitive Independence, and Mobility, using the three of the subscales of Craig Handicap Assessment and Reporting Technique Scale. The scores of each subscale has to be calculated with specific formula and weight based on the manual. The range of each subscale score are: Physical Independence: 28-100; Cognitive Independence: 15-100; and Mobility: 16-100. A higher score indicates greater independence. The analyzed results of the difference between the measurements at the end of 2nd week and 8th week were shown here.|At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||units on a scale||Standard Deviation|Mean
2755470|NCT00839098|Secondary|Questionnaire Responses: Psychological Impacts of Assistive Devices Scale|This tool is to measure perceived psychological impact of using an assistive device. It consists of three subscales, Competence (12 items), Adaptability (6 items), and Self-esteem (8 items). Each item is scored on a likert scale from -3 (decreases) to + 3 (increases). The total score is the sum of all 26 items, ranging from -78 to 78. A higher positive score indicates more positive impact. A negative score indicates negative impact. The differences between the measurements taken at the end of 2nd week (end of baseline) and the end of 8th week (end of intervention period) are reported here to show the intervention effect.|At the end of every two weeks|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||units on a scale||Standard Deviation|Mean
2755471|NCT00839098|Secondary|Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)|General Discomfort Assessment (GD) and Discomfort Intensity Rating (DI) are two sub-scales of TAWC. Higher scores indicate greater discomfort. GD consists of 8 discomfort statements and 5 comfort statements. The statements are rated on a seven point Likert scale, from strongly disagree to strongly agree of points from 1-7 (total score: 13-91). DI includes seven body areas (back, neck, buttocks, legs, arms, feet, and hands) and overall discomfort level, rated for a degree of discomfort intensity on a scale of 0 (no discomfort) to 10 (severe discomfort). Space is also included for the user to list additional body areas. DI scores may range from 0 to more than 80, depending on whether the participant reported additional areas of discomfort. Although GD and DI were measured daily, the data were average for each two-week period. The average GD and DI of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair||||units on a scale||Standard Deviation|Mean
2755472|NCT00839098|Primary|Compliance Rate|Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||Percentage of participants' compliance||Standard Deviation|Mean
2755473|NCT00839072|Secondary|Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]||24 hours|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng*h/mL||Standard Deviation|Mean
2755474|NCT00839072|Secondary|Apparent Terminal Elimination Half-Life [T½el]|The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||Hours||Standard Deviation|Mean
2755475|NCT00839072|Secondary|Time of Maximum Measured Plasma Concentration (Tmax)||72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||hours||Full Range|Median
2755476|NCT00839072|Primary|Bioequivalence Based on AUC∞|AUC∞ = Area under the concentration-time curve extrapolated to infinity|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng*h/mL||Standard Deviation|Mean
2755477|NCT00839072|Primary|Bioequivalence Based on AUCT|AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng*h/mL||Standard Deviation|Mean
2755478|NCT00839072|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng/mL||Standard Deviation|Mean
2755479|NCT00838981|Secondary|Average Number of Days Using a Substance Within Treatment||up to 90 days||||days||Standard Deviation|Mean
2755480|NCT00838981|Primary|Average Maximum Days Abstinent||up to 84 days||||days||Standard Deviation|Mean
2755481|NCT00838981|Primary|Average Number of Positive Urine Tests|thrice weekly urine tests|up to 12 weeks.||||urine tests||Standard Deviation|Mean
2755539|NCT00838526|Secondary|Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs.|Information presented within Adverse Event information.|Baseline to Week 26|||||||
2755482|NCT00838929|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Vorinostat and Radiotherapy in Patients With Brain Metastases.|"To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Vorinostat and radiotherapy in patients with brain metastases.~The maximum tolerated dose (MTD) will be one dose below the DLT occurring in at least 1 out of 3 subjects.~Dose level -2: 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1: 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I: 200 mg PO qd (initial starting dose) Dose level II: 300 mg PO qd Dose level III: 400 mg PO qd"|Weekly during treatment On Last day of treatment (30 days after last drug dose) Follow-up (every 3 months)||||mg|||Number
2755483|NCT00838916|Secondary|Albiglutide Plasma Concentrations at Week 8 and Week 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2755484|NCT00838916|Secondary|Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52|A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.|Baseline and Week 52|Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed.|||Millimoles per hour per liter (mmol.h/L)||Standard Deviation|Mean
2755485|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Kilograms||Standard Deviation|Mean
2755486|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
2755487|NCT00838916|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
2755488|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
2755489|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Participants|||Number
2755490|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2755568|NCT00838162|Primary|Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)|The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.|Baseline (Day 1), Day 8, Day 15|Intent-to treat (ITT) population- participants who received at least 1 dose of study medication (TMC310911).|||log10 copies/mL||Standard Error|Mean
2755491|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2755492|NCT00838916|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2755493|NCT00838916|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2755494|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.|||Kilograms||Standard Deviation|Mean
2755495|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 104|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.|||Kilograms||Standard Error|Least Squares Mean
2755496|NCT00838903|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
2755497|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Participants|||Number
2755498|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.|||Participants|||Number
2755499|NCT00838903|Secondary|Change From Baseline in FPG at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2755500|NCT00838903|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2755501|NCT00838903|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .|Baseline and Week 156|Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2755502|NCT00838903|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2755503|NCT00838695|Secondary|Change in Blood Pressure|change in systolic and diastolic blood pressure, comparing before and after cold pressor test. A subset of 57 participants (of the 106) who were in the primary outcome measure also participated in the cold pressor test.|baseline to 2 minutes|A subset of participants (57 of the 106) in the primary outcome measure also participated in the cold pressor test.|||mmHg||Standard Deviation|Mean
2755504|NCT00838695|Primary|ED50 After Phenylephrine|ED50 is a measurement of vein constriction and indicates 50% of maximal constriction after being given medication phenylephrine, representing sensitivity to the drug. Phenylephrine was infused at increasing dose rates, ranging from 12-9600 ng/min. The infusion at each dose rate lasted 7 minutes, with the vein diameter measured during the last 2 minutes of the infusion. The number represents the ng/ml of phenylephrine needed to reach 50% of maximal vein constriction. ED50 values were not normally distributed and were log-transformed for analysis and expressed as geometric means.|70 minutes||||ng/min||95% Confidence Interval|Geometric Mean
2755505|NCT00838682|Other Pre-specified|Duration of Hospital Stay||6wk|intention to treat (ITT)|||days||Standard Deviation|Mean
2755506|NCT00838682|Other Pre-specified|Mean Units of Blood Transfusion|In order to compare the total amount of blood transfusion, mean units of blood transfusion was used.|day 3|intention to treat (ITT)|||Mean units of blood transfusion||Standard Deviation|Mean
2755507|NCT00838682|Secondary|Death||6wk|intention to treat (ITT)|||participants|||Number
2755508|NCT00838682|Secondary|Surgery|"This sencodary endpoint surgery is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy."|6wk|intention to treat (ITT)|||participants|||Number
2755509|NCT00838682|Secondary|Rebleeding After 3 Days|Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.|6wk|intention to treat (ITT)|||participants|||Number
2755510|NCT00838682|Primary|Rebleeding Within 3 Days||day 3|intention to treat (ITT)|||participants|||Number
2755511|NCT00838630|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755512|NCT00838630|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755513|NCT00838630|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755514|NCT00838578|Primary|Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0||Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months|ITT population|||participants|||Number
2755515|NCT00838565|Other Pre-specified|Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624|Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.|Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624|Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. n=participants evaluable for this measure at specified time points for each arm, respectively.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2755516|NCT00838565|Other Pre-specified|Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation||Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation|Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter.Data collected at Early Discontinuation included those subjects who left the study early. 'N' (number of participants analyzed) = participants who were evaluable for this measure.|||10^3 cells/millimeter (mm)^3||Standard Deviation|Mean
2755517|NCT00838565|Other Pre-specified|Change From Baseline in Log CRP Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624|Data for this outcome measure was not assessed since this measure was analyzed as per sponsor discretion as the change from baseline in CRP in this study was well demonstrated with the raw CRP data. Therefore, log transformation of CRP was not performed.||||||
2755518|NCT00838565|Other Pre-specified|Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay. A decrease in the level of CRP indicates reduction in inflammation.|Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation|Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Data collected at Early Discontinuation included those subjects who left the study early.'N' (number of participants analyzed) = participants who were evaluable for this measure.|||milligram per liter (mg/L)||Standard Deviation|Mean
2755519|NCT00838565|Primary|Serum Decay Half-Life (t1/2): Day 56|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Full Range|Median
2755520|NCT00838565|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56|AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).|Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*day/mL||Standard Deviation|Geometric Mean
2755521|NCT00838565|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56||Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Full Range|Median
2755522|NCT00838565|Primary|Maximum Observed Serum Concentration (Cmax): Day 56||Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2755523|NCT00838565|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28|AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).|Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*day/mL||Standard Deviation|Geometric Mean
2755524|NCT00838565|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28||Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Full Range|Median
2755525|NCT00838565|Primary|Maximum Observed Serum Concentration (Cmax): Day 28||Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2755526|NCT00838565|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1|AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).|Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng*day/mL||Standard Deviation|Geometric Mean
2755527|NCT00838565|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1||Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||days||Full Range|Median
2755528|NCT00838565|Primary|Maximum Observed Serum Concentration (Cmax): Day 1||Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2755529|NCT00838565|Primary|Number of Participants With Positive Anti-drug Antibodies Response||Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||participants|||Number
2755530|NCT00838565|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2755531|NCT00838539|Secondary|Area Under the Curve Tau|Area Under the Curve tau of neratinib concentrations, collected at 2, 4, 8, and 24 hours post-neratinib administration, at the week 4 dose.|Week 4|Subjects who had pharmacokinetic concentrations available at the dose combination, at day 22.|||ng*hr/mL||Full Range|Geometric Mean
2755532|NCT00838539|Secondary|Objective Response Rate|Percentage of subjects with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death or last tumor assessment, up to 30 months|Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (>= 21 doses of neratinib and >= 2 doses of Temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article[s])|||percentage of participants||95% Confidence Interval|Number
2755533|NCT00838539|Secondary|Clinical Benefit Rate|Percentage of subjects with a complete response, partial response, or stable disease >= 24 weeks, as determined by investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death or last tumor assessment, up to 30 months|Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (>= 21 doses of neratinib and >= 2 doses of temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article[s]).|||percentage of participants||95% Confidence Interval|Number
2755534|NCT00838539|Secondary|Best Overall Response|The best overall response was described using the data as reported by study center investigators per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death or last tumor assessment, up to 30 months|Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (>= 21 doses of neratinib and >= 2 doses of temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article[s])|||Participants|||Count of Participants
2755535|NCT00838539|Primary|Adverse Events Causing Dose Limiting Toxicities|"A DLT was defined as any dose-limiting adverse event (AE) related to neratinib + TEMSR as follows: [1] Grade 3 or 4 nonhematologic toxicity (Grade 3 or 4 nausea, vomiting, hyperglycemia, hypophosphatemia, hypertriglyceridemia, or hypercholesterolemia was not considered a DLT unless the subject was already receiving optimal medical therapy). [2] Grade 3 or 4 diarrhea lasting >2 days while subject was on optimal vigorous antidiarrheal therapy.~[3] Grade 4 neutropenia lasting >3 days or Grade 3 or 4 neutropenia of any duration with sepsis or a fever >38.5C. [4] Platelet value less than or equal to 25,000/mm3 or bleeding requiring a platelet transfusion. [5] Delayed recovery from toxicity, which delayed rescheduled re-treatment for >3 weeks. [6] Inability to maintain the original dose during the first 28 days of treatment (at least 21 doses of neratinib and 2 doses of TEMSR at the original specified dose) due to treatment-related toxicity."|From first dose date to day 21||||Participants|||Count of Participants
2755536|NCT00838539|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Neratinib|Identification of the weekly temsirolimus high-dose MTD in combination with daily neratinib|From first dose date to day 28|Evaluable subjects include those that either experienced a dose limiting toxicity within the first 28 days, regardless of the number of doses of treatment received, or those that received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment at the original dose level prescribed.|||mg|||Number
2755537|NCT00838539|Primary|Maximum Tolerated Dose (MTD) of Neratinib in Combination With Temsirolimus|Identification of the daily neratinib high-dose MTD in combination with weekly temsirolimus.|From first dose date to day 28|Evaluable subjects were those that either experienced a dose limiting toxicity within the first 28 days, regardless of the number of doses of treatment received, or those that received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment at the original dose level prescribed.|||mg|||Number
2755538|NCT00838539|Primary|Probability of Dose-Limiting Toxicity (DLT)|A DLT was defined as any dose-limiting Adverse Event related to neratinib + Temsirolimus as Grade 3 or higher nonhematologic toxicity (except neutropenia) or Grade 3 or higher diarrhea lasting >2 days with optimal antidiarrheal therapy etc.|From first dose date to day 28|Evaluable subjects for the Maximum Tolerated Dose (MTD) contour estimation were those who either experienced a DLT within the first 28 days, regardless of the number of doses of treatment received, or received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment.|||percent probability|||Number
2755540|NCT00838526|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2755541|NCT00838526|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT|||Percentage of Participants|||Number
2755542|NCT00838513|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.|||micrograms/mil||Standard Deviation|Mean
2755543|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2755544|NCT00838513|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2755545|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
2755546|NCT00838513|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2755547|NCT00838513|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2755548|NCT00838513|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2755549|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2755550|NCT00838513|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
2755569|NCT00838136|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756854|NCT00829621|Primary|Presence of BMP-2 in Effluent Collected in IVAC Canister|Presence of BMP-2 in effluent collected in IVAC canister|12-hours, 24-hours, 36-hours, and 48-hours after IVAC application||||participants|||Number
2755551|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
2755552|NCT00838513|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
2755553|NCT00838513|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2755554|NCT00838513|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2755555|NCT00838331|Primary|The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow.|The primary outcome measures are changes in forearm blood flow (FBF) in recipients of fresh or stored RBC transfusions in response to acetylcholine. Secondary measures include changes in FBF with acetylcholine with or without L-NMMA, and changes in FBF with forearm exercise. In addition, flow mediated dilation (FMD) measurements will also be used to assess changes in brachial artery diameter before and after fresh vs aged RBC transfusions.|5 years||||mL / 100 mL / min||Standard Deviation|Mean
2755556|NCT00838279|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755557|NCT00838279|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755558|NCT00838279|Primary|Cmax - Maximum Observed Concentration|Bioequivalence basd on Cmax|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755559|NCT00838201|Primary|Overall Survival Through Month 24||24 months|Full Analysis Set|||Participants|||Number
2755560|NCT00838162|Secondary|Fluctuation Index of TMC310911|Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.|Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||Percent ng/mL||Standard Deviation|Mean
2755561|NCT00838162|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC310911||Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).|||ng/mL||Standard Deviation|Mean
2755562|NCT00838162|Secondary|Predose Plasma Concentration (C0h) of TMC310911||Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).|||ng/mL||Standard Deviation|Mean
2755563|NCT00838162|Secondary|Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||ng.h/mL||Standard Deviation|Mean
2755564|NCT00838162|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||hours||Full Range|Median
2755565|NCT00838162|Secondary|Maximum Plasma Concentration (Cmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||ng/mL||Standard Deviation|Mean
2755566|NCT00838162|Secondary|Mean Changes From Baseline in CD4+ Cell Count||Baseline (Day 1), Day 8, Day 15|Intent-to-treat (ITT) Population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||x 1000000 cells/L||Standard Error|Mean
2755567|NCT00838162|Secondary|Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period|Virologic response is a viral load test result below a chosen threshold value (less than 50 copies/mL, less than 400 copies/mL, or at least 1 log drop in viral load) at any timepoint during a 14-day treatment of 4 different dose regimens of TMC310911 coadministered with 100 mg ritonavir.|14 days|Intent-to-treat (ITT) Population- all randomized participants who received at least 1 dose of study medication (TMC310911)|||Participants|||Number
2755570|NCT00838136|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755571|NCT00838136|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755572|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study.|||percentage of participants|||Number
2755573|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study.|||percentage of participants|||Number
2755574|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
2755575|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
2755576|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2|Abnormal ECG findings included maximum value of >=300 msec, maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval; maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
2755577|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
2755578|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2|Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
2755579|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
2755580|NCT00838097|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADRs)|"An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:~Fatal~Life threatening~Required or prolonged in-patient hospitalization~A persistent or significant disability/incapacity, or~A congenital anomaly/birth defect."|2 years|Full analysis set|||participants|||Number
2755581|NCT00838097|Secondary|Parathyroid Hormone Level by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set|||pmol/L||Inter-Quartile Range|Median
2755582|NCT00838097|Secondary|Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals|Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.|Baseline and Months 1 to 24|Full analysis set|||μg/kg/month||95% Confidence Interval|Geometric Mean
2755583|NCT00838097|Secondary|Hemoglobin Concentration by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set|||g/dL||95% Confidence Interval|Mean
2755584|NCT00838097|Primary|Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)|An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).|2 years|Full Analysis Set|||participants|||Number
2755585|NCT00837967|Primary|Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||beats/min||Standard Deviation|Mean
2755586|NCT00837967|Primary|Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||mmHg||Standard Deviation|Mean
2755587|NCT00837967|Primary|Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||ms||Standard Deviation|Mean
2755588|NCT00837967|Primary|Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 140 min after start dosing for each treatment day||||mg/dLiters||Standard Deviation|Mean
2755589|NCT00837967|Primary|Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||mEq/L||Standard Deviation|Mean
2755590|NCT00837967|Primary|Adverse Events|Total number of adverse events|3 days||||adverse events|||Number
2755591|NCT00837902|Primary|Reduction in Heart Rate|Reduction in heart rate based upon genotype while exercising. Participants exercised on a recumbent bike for 2 minutes at 25W, 2 minutes at 50W, and 2 minutes at 75W twice, once before taking atenolol, and once 2.5 hours after oral administration of 25 mg of atenolol. Data points represent unadjusted mean reduction in heart rate in the 3 genotype groups.|2 exercise periods of 6 minutes each. 6 minutes of exercise before taking atenolol, and 6 minutes of exercise starting 2.5 hours after taking 25 mg of atenolol (2.5 hours + 6 minutes)|There are 3 genotypes for GRK5, GLN/GLN, GLN/LEU, and LEU/LEU. A priori analysis plan was to compare reduction in heart rate among the 3 genotypes..|||beats per minute||Standard Deviation|Mean
2755592|NCT00837876|Secondary|Number of Patients With Worst Grade Toxicities|Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.|every 4 weeks and every 8 weeks in follow-up to resolution of toxicity|All patients who received treatment with the study drugs. One patient did not receive treatment.|||participants|||Number
2755593|NCT00837876|Secondary|Number of Patients With Progression-free Survival|Participants with progression-free survival at 4 months.|at 4 months|Patients with progression-free survival at 4 months. The remaining 17 patients were not available for evaluation at 4 months due to toxicity (5), disease progression (5), patient withdrawal (1),respiratory failure (1), study drug held more than 28 days (1), and no study drug (1.|||participants|||Number
2755594|NCT00837876|Secondary|Response Rate|Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR > 30% decrease in the sum of the longest diameter (LD) of target lesions, PD > 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 4 months|Participants who received treatment for 4 or more months. The remaining 10 participants received treatment for less than 4 months and were not evaluable.|||participants|||Number
2755595|NCT00837876|Primary|Number of Patients With Progression-free Survival|Number of patients with progression-free survival at 8 weeks|at 8 weeks|Patients who received treatment for >= 8 weeks. 14 study patients were treated for < 8 weeks due to toxicity (5), disease progression (5), did not receive study drug (1), respiratory failure (1), drug held more than 28 days (1), patient withdrawal (1). The remaining 13 participants did not have a progression-free survival at 8 weeks.|||participants|||Number
2755637|NCT00837616|Primary|Change in Percent Fat Mass From Baseline in 12 Months||12 months||||percent fat mass||Standard Error|Mean
2755638|NCT00837616|Primary|Change in Body Mass Index From Baseline at 12 Months||12 months||||kg/m2||Standard Error|Mean
2755596|NCT00837824|Secondary|Plasma Globotriaosylceramide (GL-3)|This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level is defined as ≤ 7.03 µg/mL.|Evaluated at Baseline, Month 3, and Final Visit|"Fabrazyme 1mg/kg every 2 weeks: ITT population – 11 patients at baseline, 7 patients at Month 3, and 9 patients at Final Visit had Plasma GL-3 values.~Fabrazyme 3mg/kg every 2 weeks: ITT population - 9 patients at baseline, 2 patients at Month 3, and 7 patients at Final Visit had Plasma GL-3 values"|||µg/mL||Standard Deviation|Mean
2755597|NCT00837824|Primary|Time to Clinically Significant Progression of Cardiac Disease, Cerebrovascular Disease, and/or Death Among Fabry Patients With Severe Kidney Disease|The trial was terminated early due to inadequate study design. During the study period of 7 months, only 1 patient had a clinical event, a stroke, in the Fabrazyme 1 mg/kg treatment arm. The time to event was determined from first dose of Fabrazyme to the date of event.|7 months|Intent-to-Treat (ITT) Population-consisted of all 20 patients enrolled in the trial. The original sample size was 120 patients. Due to early termination, only 20 patients were enrolled in this trial. No imputation of data was performed. During the 7 months study period, only 1 patient had a clinical event in the Fabrazyme 1 mg/kg treatment arm.|||Days|||Number
2755598|NCT00837811|Secondary|Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)|The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).|Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)|Participants who received any amount of study drug.|||Participants|||Count of Participants
2755599|NCT00837811|Secondary|Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in ESR indicated an improvement in the participant's condition.|Baseline, up to Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ESR assessment, excluding site with GCP issues; LOCF.|||percent change||Standard Deviation|Mean
2755600|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies|Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.|Baseline, up to Week 52|Participants who received any amount of study drug and had at least 1 post-baseline anti-CCP assessment, excluding site with GCP issues; LOCF.|||units per milliliter (U/mL)||Standard Deviation|Mean
2755601|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.|Baseline, Week 52|Participants who received any amount of study drug and had Week 52 post-baseline RF level assessment, excluding the site with GCP issues. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.|||international units/milliliter (IU/mL)||Standard Deviation|Mean
2755602|NCT00837811|Other Pre-specified|Number of Participants Who Died, Any Cause|A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).|Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)|Participants who received any amount of study drug.|||Participants|||Count of Participants
2755603|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Serum Immunoglobulin|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels.|Baseline, up to Week 52|Participants who received any amount of study drug and had at least 1 post-baseline serum immunoglobulin assessment; LOCF.|||grams per liter (g/L)||Standard Deviation|Mean
2755639|NCT00837616|Secondary|Serum 17B Estradiol Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||pg/ml||Standard Error|Mean
2755604|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)|Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.|Baseline, Weeks 52, 60, 72, 80, 88, and 100|Participants who received any amount of study drug and had the specified peripheral blood B cell subset assessment post-baseline at the specified time points.|||cells/µL||Standard Deviation|Mean
2755605|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts|B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.|Baseline, Weeks 52, 60, 72, 80, 88, and 100|Participants who received any amount of study drug and a post-baseline total B cell assessment at the specified time points.|||cells per microliter (cells/µL)||Standard Deviation|Mean
2755606|NCT00837811|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores|SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline SF-36 assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
2755607|NCT00837811|Secondary|Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)|EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS). EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)*100. Displayed percentages may not add up to 100% because of rounding.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline EULAR28 assessment; excludes site with GCP issues; LOCF.|||percentage of participants|||Number
2755608|NCT00837811|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)|The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square root(TJC28)+0.28*square root(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline DAS28 assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
2755609|NCT00837811|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score|The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline FACIT assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
2755610|NCT00837811|Secondary|ACR-N Response|The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR-N assessment; excludes site with GCP issues; LOCF. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.|||units on a scale||Standard Deviation|Mean
2755611|NCT00837811|Secondary|Percentage of Participants Achieving ACR70 Response|ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR70 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.|||percentage of participants|||Number
2755612|NCT00837811|Secondary|Percentage of Participants ACR50 Response|ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR50 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.|||percentage of participants|||Number
2755613|NCT00837811|Secondary|Percentage of Participants Achieving ACR20 Response|ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR20 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.|||percentage of participants|||Number
2755614|NCT00837811|Secondary|Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]|CRP is an indicator of inflammation. The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline CRP assessment; excludes site with GCP issues; LOCF.|||percent change||Standard Deviation|Mean
2755615|NCT00837811|Secondary|Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)|Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of joint pain; excludes site with GCP issues; LOCF.|||mm||Standard Deviation|Mean
2755616|NCT00837811|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]|The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline HAQ-DI assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
2755617|NCT00837811|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)|Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline physician's global assessment of disease activity; excludes site with GCP issues; LOCF.|||mm||Standard Deviation|Mean
2755618|NCT00837811|Secondary|Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)|Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of disease activity; excludes site with GCP issues; LOCF.|||mm||Standard Deviation|Mean
2755619|NCT00837811|Secondary|Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)|The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline swollen joint assessment; excludes site with GCP issues; LOCF.|||swollen joints||Standard Deviation|Mean
2755620|NCT00837811|Secondary|Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]|The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline tender joint assessment; excludes site with GCP issues; Last observation carried forward (LOCF).|||tender joints||Standard Deviation|Mean
2755621|NCT00837811|Primary|Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs|For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].|Baseline through Week 112|Participants who received any amount of study drug.|||Participants|||Count of Participants
2755622|NCT00837811|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].|Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)|Participants who received any amount of study drug.|||Participants|||Count of Participants
2755623|NCT00837759|Secondary|Change in ZnT8 Autoantibody Titer||6 months following the protocol subject's randomization/treatment initiation||||Titers||Standard Error|Mean
2755624|NCT00837759|Secondary|Change in Anti-IA2 Titer||6 months following the protocol subject's randomization/treatment initiation||||Titers||Standard Error|Mean
2755625|NCT00837759|Secondary|Change in Anti-GAD Autoantibody Titers||6 months following the protocol subject's randomization/treatment initiation||||Titers||Standard Error|Mean
2755626|NCT00837759|Secondary|Change in Insulin Dose||6 months following the protocol subject's randomization/treatment initiation||||U/kg/day||Standard Deviation|Mean
2755627|NCT00837759|Secondary|Glycemia Control (Change in HbA1c Level)||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study|||Percentage||Standard Deviation|Mean
2755628|NCT00837759|Primary|Change in C-peptide||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study|||ng/mL||Standard Deviation|Mean
2755629|NCT00837694|Secondary|Height|height|visits 1 and 3|||||||
2755630|NCT00837694|Secondary|Body Weight|body weight|visit 1 and visit 3|||||||
2755631|NCT00837694|Primary|Energy Intake|energy contained in eaten foods and beverages|visits 1, 2, and 3 plus on the phone throughout the study.|||||||
2755632|NCT00837694|Primary|Number of Responses Made by Clicking a Mouse Button for Food|Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.|During 2nd and 3rd visits||||Number of button presses||Standard Error|Mean
2755633|NCT00837616|Secondary|Serum Estrone Sulfate Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||pg/mL||Standard Error|Mean
2755634|NCT00837616|Secondary|Serum Estrone Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||pg/mL||Standard Error|Mean
2755635|NCT00837616|Primary|Characterize PK/PD and Relative Biological Potency of Different Oral vs TD Estrogen Preparations||6 weeks|||||||
2755636|NCT00837616|Primary|Change in Fat Free Mass From Baseline at 12 Months||12 months||||kg||Standard Error|Mean
2755644|NCT00837590|Primary|Vascular Function|The primary endpoints of interest is flow-mediated vasodilation|Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)|Pilot study. Analyzing data from all participants completing treatment.|||ml/min||Standard Deviation|Mean
2755645|NCT00837577|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.|||mg/dL||95% Confidence Interval|Least Squares Mean
2755646|NCT00837577|Secondary|Change From Baseline in 2-hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.|||mg/dL||95% Confidence Interval|Least Squares Mean
2755647|NCT00837577|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2755648|NCT00837512|Primary|Onset Time (Tmax)|Average time to peak insulin concentration|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours||||Minutes||Standard Deviation|Mean
2755649|NCT00837486|Other Pre-specified|Therapy-related Adverse Events|Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation.|from enrollment to study closure (average follow-up of 36 months)|All enrolled participants are included in the analysis.|||participants|||Number
2755650|NCT00837486|Other Pre-specified|Long-term Open-label Responders|This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders.|at the 24-month visit|29 participants started the the Long-Term Follow-up Phase and 24 completed the phase, but all 30 enrolled participants are included in the analysis. Participants that withdrew early are counted as non-responders.|||participants|||Number
2755651|NCT00837486|Secondary|Quality of Life Change|Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.|||change from baseline score||Standard Deviation|Mean
2755652|NCT00837486|Secondary|Depression Change|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.|||percentage change from baseline||Standard Deviation|Mean
2755653|NCT00837486|Primary|Responders|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response.|Baseline to 16 weeks|29 of the 30 subjects are included in this analysis. One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.|||participants|||Number
2755654|NCT00837473|Secondary|Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void||During the time of operation, a range of 2.5-8.5 hrs||||cc||Standard Deviation|Mean
2755655|NCT00837473|Secondary|Surgical Outcome--length of Hospital Stay||From admission to discharge, a range of 2 to 20 days||||days||Standard Deviation|Mean
2755656|NCT00837473|Secondary|Surgical Outcome--blood Loss||During the time of operation, a range of 2.5-8.5 hrs||||ml||Standard Deviation|Mean
2755657|NCT00837473|Secondary|Surgical Outcome--operative Time||The time of operation, a range of 2.5-8.5 hrs||||min||Standard Deviation|Mean
2755658|NCT00837473|Secondary|Surgical outcome-the Amount of Cancellous Bone Harvested||During the time of operation, a range of 2.5-8.5 hrs||||cc||Standard Deviation|Mean
2755659|NCT00837473|Secondary|Surgical Related Outcome--locations of Iliac Crest Bone Harvest||During the time of operation, a range of 2.5-8.5 hrs||||Participants|||Count of Participants
2755660|NCT00837473|Secondary|Pain Status Assessed by Visual Analog Scale (VAS)|The visual analog scale (VAS) was used for assessing pain status in the body locations of back/neck, left leg/arm, and right arm/leg. Subjects were asked to rate their perception of pain in VAS, generated by the Osteotech Clinical Department. The scale from 1 to 5 represented the pain levels at none, mild, average, severe, and extreme.|Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||units on a scale||Standard Deviation|Mean
2755703|NCT00837031|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months||||months||95% Confidence Interval|Median
2755661|NCT00837473|Secondary|Oswestry Disability Index|The Oswestry Disability Index (ODI) is an internationally validated questionnaire consisting of ten sets of statements which focus on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and ability to travel. ODI scores are in a range of 0 to 100, with a lower score indicating less pain and disability and higher scores indicating more pain and disability.|Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||units on a scale||Standard Deviation|Mean
2755662|NCT00837473|Secondary|General Health Status|The general health status was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36v2). The SF-36v2 questionnaire contains 36 questions pertaining to eight subscales of health status. These eight subscales can be summarized as relating to either physical health or mental health. The physical component summary (PCS) is based primarily on the physical functioning, role-physical, bodily pain, and general health scales of the SF-36v2 survey. The mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||units on a scale||Standard Deviation|Mean
2755663|NCT00837473|Primary|Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist|"Reconstitution of bone growth was determined by an independent radiologist based on bony ingrowth and absence of a gap according to the following criteria:~Absent: limited or no bone mineralization visualized at the defect site; extensive areas of radiolucency.~Mild: identifiable bone mineralization and coalescence of the bone graft mass of < 50% of the defect site.~Moderate: identifiable bone mineralization and coalescence of the bone graft mass over > 50% of the defect site; some remaining unmineralized areas of radiolucency; limited evidence of partial bone remodeling and trabeculation.~Extensive: > 75% of bone mineralization over the defect site showing a contiguous and completely coalesced bone graft mass with confluent trabecular pattern."|6 wks, 3 mths, 6 mths 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||Participants|||Count of Participants
2755664|NCT00837447|Primary|Change in Knee Society Knee Score|"change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome.~Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points"|baseline and 3 years||||scores on a scale||Standard Deviation|Mean
2755665|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.|||percentage of participants|||Number
2755666|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.|||percentage of participants|||Number
2755667|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.|||percentage of participants|||Number
2755668|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.|||percentage of participants|||Number
2755682|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|3 months||||µm||Standard Deviation|Mean
2755720|NCT00836875|Secondary|Time to Death||Baseline up to 1 month post treatment|Safety population; only participants who died were included in the analysis.|||days||Full Range|Median
2755669|NCT00837434|Secondary|"Percentage of Participants Fulfilling DAS-28-CRP Good or Moderate Response Criteria at Week 24"|Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline -Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.|||percentage of participants|||Number
2755670|NCT00837434|Secondary|"Percentage of Participants Fulfilling DAS-28-CRP Good or Moderate Response Criteria at Week 12"|Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline -Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point].|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.|||percentage of participants|||Number
2755671|NCT00837434|Primary|Percentage of CD27+ Switched Memory B Cells at Week 12|Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.|Week 12|The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations.|||Percentage of B Cells||Standard Deviation|Mean
2755672|NCT00837330|Primary|Commonly Reported and Notable Adverse Events|Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.|2 years||||participants|||Number
2755673|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 6 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms.|6 Months||||µg||Standard Deviation|Mean
2755674|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 3 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms.|3 Months||||µg||Standard Deviation|Mean
2755675|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 6 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum.|6 Months||||ng/dL||Standard Deviation|Mean
2755676|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 3 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum.|3 Months||||ng/dL||Standard Deviation|Mean
2755677|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum.|6 Months|Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis.|||pg/mL||Standard Deviation|Mean
2755678|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum.|3 Months||||pg/mL||Standard Deviation|Mean
2755679|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 6 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|6 Months||||µL||Standard Deviation|Mean
2755680|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 3 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|3 Months||||µL||Standard Deviation|Mean
2755681|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months||||µm||Standard Deviation|Mean
2755683|NCT00837252|Secondary|Change in Visual Acuity at Month 6 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months||||ETDRS letters||Standard Deviation|Mean
2755684|NCT00837252|Primary|Change in Visual Acuity at Month 3 Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|3 months||||ETDRS letters||Standard Deviation|Mean
2755685|NCT00837213|Secondary|Percentage of Particpants With IGA Score at Week 16|"Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment~IGA:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe"|Baseline, Week 16|Subjects who completed week 16|||Percent of participants|||Number
2755686|NCT00837213|Primary|Change in Investigator Global Assessment (IGA)|"Change in Investigator Global Assessment (IGA) Average values chest and back.~IGA scale:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe"|Baseline, Weeks 4, 8,12, and 16|ITT|||Units on a scale||Standard Deviation|Mean
2755687|NCT00837213|Secondary|Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12|Percent change in total lesions (chest and back) from baseline to Week 12|Week 12|ITT|||Percent change||Standard Deviation|Mean
2755688|NCT00837213|Secondary|Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12|Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12|Baseline, Week 12|ITT|||Percent change||Standard Deviation|Mean
2755689|NCT00837213|Secondary|Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12|Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12|Baseline, Week 12|ITT|||Percent Change||Standard Deviation|Mean
2755690|NCT00837213|Primary|Percent Change in Total Acne Lesion Counts From Baseline to Week 16|Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)|Baseline, Week 16|ITT|||Percent Change||Standard Deviation|Mean
2755691|NCT00837213|Primary|Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.|Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.|Baseline, Week 16|ITT|||Percent Change||Standard Deviation|Mean
2755692|NCT00837213|Primary|Percent Change in Inflammatory Acne Lesions From Baseline to Week 16|Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)|Baseline, Week 16|ITT|||Percent change||Standard Deviation|Mean
2755693|NCT00837200|Primary|Study Specific Measure (Number of Participants Taken Off Study)||16 weeks||||participants|||Number
2755694|NCT00837200|Primary|Study Specific Measure (Response)||16 Weeks||||participants|||Number
2755695|NCT00837200|Primary|Tumor Response|"Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU~Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles~MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion~Stable disease > 2mo was a response"|16 weeks||||participants|||Number
2755696|NCT00837161|Secondary|Discomfort Level|Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.~Analysed subject numbers were:~from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"|||units on a scale||Full Range|Mean
2755697|NCT00837161|Secondary|Numerical Range Scale (NRS) of Pain Level|Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.~Analysed subject numbers were:~from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"|||units on a scale||Full Range|Mean
2755698|NCT00837161|Secondary|Length of Time to Return to Normal Activities|Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)]|per protocol|||days||Full Range|Mean
2755699|NCT00837161|Secondary|HIFU Treatment Equals Location Per Hysterectomy|Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.|Day 0, Hysterectomy|All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.|||participants|||Number
2755700|NCT00837161|Primary|Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)|Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.|||treatment-related AE/patient||Full Range|Mean
2755704|NCT00837031|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|18 months||||months||95% Confidence Interval|Median
2755705|NCT00837031|Primary|Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment|The percentage of patients who were alive 6 months after beginning treatment|6 months||||percentage of participants||95% Confidence Interval|Number
2755706|NCT00836953|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)|Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.|Day 0 and Day 14 Post-dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.|||Percentage of Participants|||Number
2755707|NCT00836953|Other Pre-specified|Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.|Day 0 and Day 14 after Dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.|||Percentage of Participants|||Number
2755708|NCT00836953|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination|Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.|Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population|||Participants|||Number
2755709|NCT00836927|Secondary|Duration of Response (DOR)|For participants who demonstrated a confirmed response (Completed Response [CR] or Partial Response [PR]) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.|Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment and who experienced a CR or PR.|||Days|||Number
2755710|NCT00836927|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.|Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Participants|||Count of Participants
2755711|NCT00836927|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up.|Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Days||Full Range|Mean
2755712|NCT00836927|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first documented progressive disease (PD), or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS for all participants is presented in days.|Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Days||Full Range|Mean
2755713|NCT00836927|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.|Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Participants|||Count of Participants
2755714|NCT00836901|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2755715|NCT00836901|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2755716|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng/mL||Standard Deviation|Mean
2755717|NCT00836901|Primary|AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2755718|NCT00836901|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755719|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755723|NCT00836875|Secondary|Percentage of Participants With a Global Response of Success|Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.|Weeks 6 and End of Treatment (EOT; up to Week 12)|Modified intent to treat (MITT) population: all participants receiving at least 1 dose of study drug and diagnosed with proven or probable aspergillosis (defined by modified European Organization for Research and Treatment of Cancer Mycoses Study Group [EORTC/MSC] criteria) or microbiologically confirmed scedosporium or fusarium infection.|||percentage of participants||95% Confidence Interval|Number
2755724|NCT00836875|Primary|Number of Participants With Adverse Events (AEs)||Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment|Safety population|||participants|||Number
2755725|NCT00836810|Secondary|Clinician's Opinion of Disease Activity.|100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse)|Current at baseline and after 2 weeks treatment||||mm||Standard Deviation|Mean
2755726|NCT00836810|Secondary|Patient's Opinion of Condition|100mm visual analogue scale. Question: Considering all the ways your pain and/or stiffness affect(s) you, please mark on the line how well you are doing. Anchors: Very well; Very badly. Min 0 Max 100 (poor outcome).|Current value at baseline and after 2 weeks treatment||||mm||Standard Deviation|Mean
2755727|NCT00836810|Secondary|Pain (Severity)|100mm visual analogue scale. Question: How much pain have you had in the last 24 hours? Anchors: No pain; Severe pain. Min score 0, Max score 100. Higher value is worse outcome.|24 hour period after 2 weeks of treatment||||mm||Standard Deviation|Mean
2755728|NCT00836810|Secondary|Percentage Change in Morning Stiffness|How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value.|2 weeks||||percentage of baseline morning stiffness||Standard Deviation|Mean
2755729|NCT00836810|Primary|Change in Area Under the Curve (AUC) of Plasma IL-6|Pre-treatment (Night A) AUC minus post-treatment (Night B) AUC. AUC calculated from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B).|24 hour measurements 2 weeks apart||||pg*hr/ml||Standard Deviation|Mean
2755730|NCT00836810|Primary|Change in Peak Serum IL-6 Concentration|Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one.|24 hours||||pg/ml||Standard Deviation|Mean
2755731|NCT00836758|Secondary|Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)|Methodological comparisons utilizing ICC for detection of AHI, apnea index (AI) and hypopnea index (HI) were caculated between the values obtained by PSG and the REMstar Auto with A-Flex device.|one night||||coefficient|Overnight PSG and AED algorithms||Number
2755732|NCT00836758|Primary|Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm|"Apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. The Apnea index (AI) is the average number of apneas that occur per hour of sleep. The Hypopnea index (HI) is the average number of hypopneas that occur per hour of sleep.~The PSGs were manually scored to determine the apnea-hypopnea index. This value was then compared to the PAP device which utilized the AED algorithm to determine the apnea-hypopnea index."|one night||||events per hour|Overnight PSG and AED algorithms|Standard Deviation|Mean
2755733|NCT00836745|Secondary|Number of Participants Who Required Management of Other Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.|||participants|||Number
2755734|NCT00836745|Secondary|Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.|||participants|||Number
2755735|NCT00836745|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)|Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.|||percentage of participants||95% Confidence Interval|Number
2755736|NCT00836745|Primary|Progression Free Survival (PFS)|PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.|Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)|Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.||||||
2755739|NCT00836706|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755740|NCT00836706|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755741|NCT00836706|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755742|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||participants|||Number
2755743|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||participants|||Number
2755744|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percentage of yes responses||Standard Deviation|Mean
2755745|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percentage of yes responses||Standard Deviation|Mean
2755746|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)?  Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percentage of yes responses||Standard Deviation|Mean
2755747|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
2755748|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
2755749|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
2755750|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
2755751|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
2755752|NCT00836693|Secondary|The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint|The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
2755860|NCT00835861|Secondary|Number of Patients With Obstetric Complications|Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.|Throughout pregnancy until hospital discharge following delivery.||||participants|||Number
2755753|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary|The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percent||Standard Deviation|Mean
2755754|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percent of volumetric change||Standard Deviation|Mean
2755755|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||minutes||Standard Deviation|Mean
2755756|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||Number of events per night||Standard Deviation|Mean
2755757|NCT00836693|Primary|Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.|||percentage of yes responses||Standard Deviation|Mean
2755758|NCT00836693|Primary|Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant."|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.|||percentage of yes responses||Standard Deviation|Mean
2755759|NCT00836693|Primary|Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.|||units on a scale||Standard Deviation|Mean
2755760|NCT00836641|Secondary|Number of Vaccinees With Adverse Events|we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.|12 months||||participants|||Number
2755761|NCT00836641|Primary|Immunogenicity of Pneumococcal Vaccination|we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml).|12 months|we performed a power calculation in advance. To demonstrate a difference wit p<0.05, we would require 30 subjects per arm each. Thus and to allow potential drop-outs, we included 35 subjects per arm.|||[µg/ml]||95% Confidence Interval|Geometric Mean
2755762|NCT00836589|Secondary|Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.|The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.|5 years||||ohms||Standard Deviation|Mean
2755763|NCT00836589|Secondary|Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.|The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.|5 years||||millivolts (mV)||Standard Deviation|Mean
2755764|NCT00836589|Secondary|Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.|Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold of each Linox Lead System model was calculated as a mean across all study visits.|5 years||||Volts (V)||Standard Deviation|Mean
2755765|NCT00836589|Secondary|Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.|The mean pacing impedance measurement is calculated as a mean across all study visits.|5 years|17 subjects were excluded due to incomplete data.|||ohms||Standard Deviation|Mean
2755766|NCT00836589|Secondary|Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.|The mean sensing measurement is calculated as a mean across all study visits.|5 years|17 subjects were excluded due to incomplete data.|||millivolts (mV)||Standard Deviation|Mean
2755767|NCT00836589|Secondary|Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.|Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold is calculated as a mean across all study visits.|5 years|17 subjects were excluded due to incomplete data.|||Volts (V)||Standard Deviation|Mean
2755768|NCT00836589|Secondary|Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.||5 years|The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and had an RA lead implanted for any duration and/or who experienced a secondary endpoint adverse event (RA lead related).|||subjects with adverse event|||Number
2755769|NCT00836589|Secondary|Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.||5 years|The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a secondary endpoint adverse event (ICD lead, device, implant procedure, or other related).|||Participants|||Count of Participants
2755770|NCT00836589|Primary|Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type|Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.|5 years|The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.|||Participants|||Count of Participants
2755771|NCT00836589|Primary|Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead|The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).|5 years|The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.|||percentage of subjects||95% Confidence Interval|Number
2755772|NCT00836498|Secondary|Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3|||||||
2755773|NCT00836498|Secondary|Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3|||||||
2755774|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
2755775|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
2755776|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
2755777|NCT00836498|Primary|Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3|||||||
2755778|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
2755779|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
2755780|NCT00836498|Primary|Part II: Number of Participants With Serious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 180 days following the third dose of RotaTeq™ and/or placebo|||||||
2755781|NCT00836498|Primary|Part II: Number of Participants With Nonserious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 42 days following any dose of RotaTeq™ and/or placebo|||||||
2755782|NCT00836498|Primary|Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
2755783|NCT00836498|Primary|Part I: Number of Participants With Serious Adverse Experiences (SAEs)|"All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.~SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose."|Up to 180 days following the third dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience."|||participants|||Number
2755784|NCT00836498|Primary|Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)|All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.|Up to 42 days following any dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience."|||participants|||Number
2755785|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755786|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755787|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755788|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755789|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755790|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755791|NCT00836433|Secondary|Change in Facility Fall Rates|Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).|6 months|"This is a facility level analysis of the fall rates in the 4 facilities randomized to FALLS alone compared to the 4 receiving CONNECT + FALLS. Within these groups, medical records from 293 and 358 residents with falls were abstracted to calculate the fall rates, therefore the number of participants analyzed is not the same as the flow module."|||change in falls per bed per year|Participants||Number
2755792|NCT00836433|Primary|Fall-related Process Measures|The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.|6 months|Note that the number of participants analyzed is not the same as the number of participants in the flow module. This is because this outcome measure is based not on the consented staff participants in the intervention, but resident charts abstracted in the pre and post intervention periods (waiver of consent obtained).|||proportion of indicators completed||Standard Deviation|Mean
2755793|NCT00836407|Secondary|Progression Free Survival (PFS)|PFS is defined as the number of months from the date of randomization to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|6 months|||||||
2755794|NCT00836407|Secondary|Immune Related Best Overall Response Rate (irBOR)|Immune Related Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve.|4 years|||||||
2755795|NCT00836407|Secondary|Overall Response Rate (ORR)|ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) during the first 6 months of treatment. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.|6 months|||||||
2755796|NCT00836407|Secondary|Overall Survival (OS)|OS will be measured from date of randomization until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).|4 years||||Months||95% Confidence Interval|Median
2755797|NCT00836407|Primary|Percent of Patients Experiencing an Unacceptable Toxicity|Unacceptable toxicity is defined as drug related >grade 4 AEs or grade 3 AEs including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.|4 years||||Percentage of Participants|||Number
2755800|NCT00836355|Primary|Indices of Salvaged Ischemic Penumbra and of Final Infarct Volume Based on Quantitative Volumetric Analyses of Pre- and Post-treatment Perfusion-weighted and Diffusion-weighted Brain MR Imaging||Within approximately 7 days of stroke onset|Although all participants completed the study, none of them had the necessary MRIs performed to gather outcome measure data. The study was closed once it was determined that logistically, it was not possible to complete the study at that point in time.||||||
2755801|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group||baseline||||Raman spectrocopy intensity counts||Standard Deviation|Mean
2755802|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma||baseline||||Raman spectroscopy intensity counts||Standard Deviation|Mean
2755803|NCT00836342|Primary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects|Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.|baseline|Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed.|||Raman spectroscopy intensity counts||Standard Deviation|Mean
2755804|NCT00836277|Secondary|1-year (Overall) Survival Rate||1 year||||percentage of participants|||Number
2755805|NCT00836277|Secondary|Overall Survival (OS)||Up to 45 months (cohort)||||months||95% Confidence Interval|Median
2755806|NCT00836277|Secondary|Progression-free Survival (PFS)|Survival time the is free of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 45 months (cohort)||||months||95% Confidence Interval|Median
2755807|NCT00836277|Primary|Clinical Benefit Rate (CBR)|Using RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 14 months||||percentage of participants||95% Confidence Interval|Number
2755808|NCT00836277|Primary|Response Rate (RR)|Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 14 months||||percentage of participants||95% Confidence Interval|Number
2755809|NCT00836095|Secondary|Insertion Success Rate|Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.|During intubation of the patient||||Number of successful airway insertions|||Number
2755810|NCT00836095|Primary|Insertion Time|The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.|During intubation of the patient||||seconds||Standard Deviation|Mean
2755811|NCT00836056|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755812|NCT00836056|Primary|Bioequivalence Based on AUCinf|AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755813|NCT00836056|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755814|NCT00836017|Secondary|Pain Numeric Rating Scale Score|Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.|||score on a scale||Standard Deviation|Mean
2755815|NCT00836017|Secondary|Percentage of Participants With Improvement in the Patient Global Impression of Change|The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.|||percentage of participants|||Number
2755816|NCT00836017|Secondary|Percentage of Participants With Improvement in Clinicians Global Impression of Change|The physician evaluated the change in the patient's present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.|||percentage of participants|||Number
2755817|NCT00836017|Secondary|Percentage of Participants With Cervical Dystonia (CD) Severity Mild|The physician assessed the patient's severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.|||percentage of participants|||Number
2755818|NCT00836017|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.|||score on a scale||Standard Deviation|Mean
2755819|NCT00836004|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755820|NCT00836004|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755821|NCT00836004|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755822|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755823|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755824|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755825|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755826|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755827|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755828|NCT00835978|Secondary|PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.|||Months||95% Confidence Interval|Median
2755829|NCT00835978|Secondary|ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants||95% Confidence Interval|Number
2755830|NCT00835978|Secondary|Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Ratio||Standard Deviation|Mean
2755831|NCT00835978|Secondary|Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
2755861|NCT00835861|Primary|Blood Glucose Measurements|Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.|Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery|For 1 infant in each group, the initial neonatal glucose value was missing.|||mg/dL||Inter-Quartile Range|Median
2755832|NCT00835978|Secondary|Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Ratio||Standard Deviation|Mean
2755833|NCT00835978|Secondary|Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
2755834|NCT00835978|Secondary|Change From Baseline in Diastolic Blood Pressure|Value at respective visit minus value at baseline.|At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.|The SA population consists of all participatns who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2755835|NCT00835978|Secondary|Change From Baseline in Systolic Blood Pressure|Value at respective visit minus value at baseline|At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.|The SA population consists of all participatns who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2755836|NCT00835978|Secondary|Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||L||95% Confidence Interval|Geometric Mean
2755837|NCT00835978|Secondary|Apparent Oral Clearance (CL/F) of Axitinib|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||L/hr||95% Confidence Interval|Geometric Mean
2755838|NCT00835978|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hr||Standard Deviation|Mean
2755839|NCT00835978|Secondary|Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib|Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||ng.hr/mL||95% Confidence Interval|Geometric Mean
2755840|NCT00835978|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||ng.hr/mL||95% Confidence Interval|Geometric Mean
2755841|NCT00835978|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,|Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hrs||Full Range|Median
2755842|NCT00835978|Secondary|Maximum Observed Plasma Concentration (Cmax) of Axitinib|Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||ng/mL||95% Confidence Interval|Geometric Mean
2755843|NCT00835978|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Months||95% Confidence Interval|Median
2755844|NCT00835978|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks|Subset of Full Analysis (FA) and Safety Analysis (SA) patients who achieved confirmed complete or partial response. FA included all randomized patients and was based on randomized treatment assignment regardless of whether or not study drug was administered. SA included all non randomized patients who received at least one dose of study medication.|||Months||95% Confidence Interval|Median
2755845|NCT00835978|Secondary|Progression-Free Survival (PFS)|The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Months||95% Confidence Interval|Median
2755846|NCT00835978|Primary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of Participants||95% Confidence Interval|Number
2755847|NCT00835926|Primary|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay|Day 21 Post-vaccination|The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2755848|NCT00835926|Primary|Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 21 Post-vaccination|The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2755849|NCT00835926|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 21 Post-vaccination|The Geometric mean titers were analyzed in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
2755850|NCT00835926|Primary|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®|"Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.~Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia"|Days 0 to 3 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
2755851|NCT00835900|Secondary|Rates of Smoking Cessation.|To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.|12 weeks after quit date.|ITT|||Participants|||Count of Participants
2755852|NCT00835900|Primary|Change in Smoking Behavior|Change in cigarettes per day from Week 2 to Week 5|Change in cigarettes per day from Week 2 to Week 5|ITT|||Change in Cigarettes Per Day||Standard Error|Mean
2755853|NCT00835861|Secondary|Number of Babies With Adverse Neonatal Outcomes|Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.|Delivery until hospital discharge|"For 1 infant in the metformin group, the adverse neonatal outcome data was missing."|||number of babies|||Number
2755854|NCT00835861|Secondary|Number of Episodes Maternal Hypoglycemia|Maternal glucose < 60 mg/dL|Baseline throughout pregnancy until time of delivery||||Number of episodes|||Number
2755855|NCT00835861|Secondary|Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)|NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130|Baseline throughout pregnancy until time of delivery||||percent of glucose values|||Number
2755856|NCT00835861|Secondary|Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)|NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95|Baseline throughout pregnancy until time of delivery||||percent of glucose values|||Number
2755862|NCT00835796|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755863|NCT00835796|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755864|NCT00835796|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755865|NCT00835731|Secondary|Women's Satisfaction With Cervical Ripening Method|"Scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied"|5 hours after placement of ripening agent||||units on a scale||Inter-Quartile Range|Median
2755866|NCT00835731|Secondary|Subject Pain During Dilation and Evacuation|"Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:~0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain~Higher values represent a worse outcome."|3-4 hours after placement of ripening agent||||Scores on a scale||Inter-Quartile Range|Median
2755867|NCT00835731|Secondary|Subject Pain During Ripening|"Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:~0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain~Higher values represent a worse outcome."|3-4 hours after placement of ripening agent||||Scores on a scale||Inter-Quartile Range|Median
2755868|NCT00835731|Secondary|Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt||3-4 hours after placement of ripening agent||||participants|||Number
2755869|NCT00835731|Secondary|Procedure Time for Dilation and Evacuation||3-4 hours after placement of ripening agent||||minutes||Inter-Quartile Range|Median
2755870|NCT00835731|Secondary|Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report|"Scale:~None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)"|3-4 hours after placement of ripening agent||||Participants|||Count of Participants
2755871|NCT00835731|Primary|Cervical Dilation in Women Following Exposure to Either Ripening Agent||3-4 hours after placement of ripening agent||||mm||Standard Deviation|Mean
2755872|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755873|NCT00835705|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755874|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755875|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755876|NCT00835705|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755877|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755878|NCT00835692|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755879|NCT00835692|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755880|NCT00835692|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755881|NCT00835679|Secondary|Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration||From day 15 (day of surgery) to 30 days after surgery|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers.No patients received any study drugs. This study was closed prematurely due to slow accrual.||||||
2755882|NCT00835679|Secondary|Number of Patients With the Given Severity of Adverse Event Within a Specified Duration|Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death.|weekly to day 15, and at followup on day 30|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No patients were accrued to Cohorts B, C, D. This study was closed prematurely due to slow accrual.||||||
2755883|NCT00835679|Secondary|Patients With Reduction of Biomarkers in Tumor Tissue|Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total & phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%)|study entry to day 15|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.||||||
2755884|NCT00835679|Primary|Patients With a Biologic Response|Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%).|on baseline and preoperatively on day of surgery (day 15)|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.||||||
2755885|NCT00835666|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755886|NCT00835666|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755887|NCT00835666|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755888|NCT00835640|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755889|NCT00835640|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755890|NCT00835640|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755891|NCT00835614|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755892|NCT00835614|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755893|NCT00835614|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755894|NCT00835588|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755895|NCT00835588|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all subjects data could be used to estimate AUC0-inf.|||ng*h/mL||Standard Deviation|Mean
2755896|NCT00835588|Primary|Cmax - Maximum Observed Concentration - Pantoprazole in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755897|NCT00835575|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2755898|NCT00835575|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2755899|NCT00835575|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2755900|NCT00835549|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755901|NCT00835549|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755902|NCT00835549|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755903|NCT00835536|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755904|NCT00835536|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755905|NCT00835510|Primary|Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra|Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).|42 days|Patients with negative cultures excluded. Use per protocol population|||Participants|||Number
2755906|NCT00835510|Secondary|Safety and Adverse Event Profile||42 days|||||||
2755907|NCT00835510|Secondary|Clinical Cure|"The following 8 signs and symptoms are rated at each visit:~Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning~Each symptom is evaluated using the following scale:~0 = None- Complete absence of any sign or symptom~= Mild - obvious but minimal involvement~= Moderate - something that is easily noted~= Severe - quite marked~Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2."|42 days|ITT population|||Participants|||Number
2755908|NCT00835510|Secondary|Mycologic Cure|Negative KOH and fungal culture at day 42|42 days|ITT population|||Participants|||Number
2755909|NCT00835510|Secondary|Therapeutic Cure|Subject with clinical and mycological cure at day 7|7 days|ITT Population|||Participants|||Number
2755910|NCT00835510|Primary|Therapeutic Cure - Superiority Analysis|"Therapeutic Cure requires both Clinical Cure and Mycological Cure.~Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.~Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative."|42 days|Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit.|||Participants|||Number
2755911|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]- Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755912|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755913|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755914|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755915|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755916|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755917|NCT00835484|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755918|NCT00835484|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755919|NCT00835484|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755920|NCT00835406|Primary|Bioequivalence Based on Ae0-36|Ae0-36 = cumulative urine excretion|Urine collected over 36 hour period||||ng/mL||Standard Deviation|Geometric Mean
2755921|NCT00835406|Primary|Bioequivalence Based on Rmax|Rmax = maximum rate of urinary excretion|Urine collected over 36 hour period||||ng/mL||Standard Deviation|Geometric Mean
2755922|NCT00835380|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all subjects who were vaccinated at least one dose and had safety follow-up data|||participants|||Number
2755942|NCT00835263|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755923|NCT00835380|Primary|Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.|"Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines.~HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL."|Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)|Per-protocol population, defined as all HAV-susceptible subjects who completed the vaccination regimen within acceptable day ranges, had 2 valid serology results on Day 0 and Month 7, and met all inclusion/exclusion criteria.|||Percentage of Participants|||Number
2755924|NCT00835367|Secondary|AUC0-t - Benazeprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755925|NCT00835367|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755926|NCT00835367|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755927|NCT00835367|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755928|NCT00835367|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755929|NCT00835367|Primary|Cmax - Benazepril|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755930|NCT00835367|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
2755931|NCT00835367|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
2755932|NCT00835367|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg/mL||Standard Deviation|Mean
2755933|NCT00835354|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755934|NCT00835354|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755935|NCT00835354|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755936|NCT00835341|Secondary|Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia||from 3 months to 124 months|||||||
2755937|NCT00835341|Primary|The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia|The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.|from 3 months to 124 months||||participants|||Number
2755938|NCT00835276|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755939|NCT00835276|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755940|NCT00835276|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755941|NCT00835263|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755944|NCT00835237|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the vaccination up to Day 182||||subjects|||Number
2755945|NCT00835237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period||||subjects|||Number
2755946|NCT00835237|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results|||subjects|||Number
2755947|NCT00835237|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results|||subjects|||Number
2755948|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.|"Vaccine response using alternative definitions defined as:~For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.~For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2755949|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off|"Booster response defined as :~For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.~For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2755950|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off|"Booster response defined as :~For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.~For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2755951|NCT00835237|Secondary|Anti-T and Anti-D Antibody Concentrations|Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||IU/mL||95% Confidence Interval|Geometric Mean
2755952|NCT00835237|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration|Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
2755953|NCT00835237|Primary|Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value|"Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).~Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL)~Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL"|One month after vaccination.|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2755954|NCT00835224|Primary|Blood Pressure||Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration||||mmHg||Standard Deviation|Mean
2755955|NCT00835211|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg*h/mL||Standard Deviation|Mean
2755956|NCT00835211|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 12 hour period|AUC0-inf could not be estimated for one subject in the reference arm.|||pg*h/mL||Standard Deviation|Mean
2755957|NCT00835211|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg/mL||Standard Deviation|Mean
2755958|NCT00835198|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of lesions||Standard Deviation|Mean
2755991|NCT00835081|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2758420|NCT00816751|Primary|Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)|VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain|at completion of procedure||||units on a scale||Standard Deviation|Mean
2755959|NCT00835198|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
2755960|NCT00835198|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
2755961|NCT00835198|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12|Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of Lesions||Standard Deviation|Mean
2755962|NCT00835185|Secondary|Kirsten Rat Sarcoma (KRAS) Mutation Status|Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.|Baseline|All enrolled participants who had assessment of tumor tissue samples at baseline.|||participants|||Number
2755963|NCT00835185|Secondary|Change From Baseline in Tumor Size||Baseline, 29 Months|Zero participants were analyzed, the outcome measure was registered in error.||||||
2755964|NCT00835185|Secondary|Vss at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Vss results were not collected.||||||
2755965|NCT00835185|Secondary|CL at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, CL results were not collected.||||||
2755966|NCT00835185|Secondary|t1/2 at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour post dose|Zero participants were analyzed, t1/2 results were not collected.||||||
2755967|NCT00835185|Secondary|Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, AUC results were not collected.||||||
2755968|NCT00835185|Secondary|Cmax at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Cmax results were not collected.||||||
2755969|NCT00835185|Secondary|Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate Vss.|||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2755970|NCT00835185|Secondary|Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1|CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate CL.|||milliliters/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2755971|NCT00835185|Secondary|Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1|The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate t1/2.|||hours (h)||Full Range|Geometric Mean
2755972|NCT00835185|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate AUC(0-∞).|||micrograms*hour/milliliter (µg*h/mL)]||Geometric Coefficient of Variation|Geometric Mean
2755973|NCT00835185|Secondary|Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had pharmacokinetic (PK) data available to calculate Cmax.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2755974|NCT00835185|Secondary|Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.|Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)|All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline.|||participants|||Number
2755992|NCT00835081|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755993|NCT00835081|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755975|NCT00835185|Secondary|Duration of Response|The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.|Time of response to time of measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2.|||months||95% Confidence Interval|Median
2755976|NCT00835185|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death|The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to end of treatment and 30-day post treatment follow-up up to 31 months|All enrolled participants who received any quantity of study drug.|||participants|||Number
2755977|NCT00835185|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.|First dose to measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =13.|||months||95% Confidence Interval|Median
2755978|NCT00835185|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.|First dose to date of death from any cause up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =14.|||months||95% Confidence Interval|Median
2755979|NCT00835185|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )|CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100.|Up to 30 Months|All enrolled participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2755980|NCT00835172|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2755981|NCT00835172|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for three subjects.|||ng*h/mL||Standard Deviation|Mean
2755982|NCT00835172|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2755983|NCT00835159|Primary|Incidence of POD|Is the incidence of POD not affected by rivastigmine treatment or not.|72 hours postoperatively||||participants|||Number
2755984|NCT00835146|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2755985|NCT00835146|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2755986|NCT00835120|Secondary|Change in Clinical Global Impressions-Bipolar Version (CGI-BP)|"The CGI-BP asks the clinician one question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|Week 0 - Week 8||||units on a scale||Standard Error|Least Squares Mean
2755987|NCT00835120|Secondary|Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores|A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.|Week 0 - Week 8||||participants|||Number
2755988|NCT00835120|Secondary|Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)|A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.|Week 0 - Week 8||||participants|||Number
2755989|NCT00835120|Secondary|Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score|The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome|Week 0 - Week 8||||units on a scale||Standard Error|Least Squares Mean
2755990|NCT00835120|Primary|Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 8||||units on a scale||Standard Error|Least Squares Mean
2755994|NCT00835068|Secondary|Subjective Assessment of Ease of Use by Participant|Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.|||participants|||Number
2755995|NCT00835068|Secondary|Subjective Assessment of Efficacy by Physician|Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.|||participants|||Number
2755996|NCT00835068|Secondary|Dose Per Injection of BeneFIX|Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period.|||IU/kg||Standard Deviation|Mean
2755997|NCT00835068|Secondary|Subjective Assessment of Efficacy by Participant|Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.|||participants|||Number
2755998|NCT00835068|Secondary|Total Consumption of BeneFIX|Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX. Participants with at least one follow-up visit were evaluable for this outcome measure.|||International Unit (IU)||Standard Deviation|Mean
2755999|NCT00835068|Secondary|Number of Bleeding Episodes Requiring Treatment by Injection|Number of injections (1, 2, 3 or greater than or equal to [>= 4]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'number of bleeding episodes analyzed' signifies episodes evaluable for this measure. ‘n’ signifies those bleeding episodes with injection data available during specified period.|||bleeding episodes|Participants||Number
2756000|NCT00835068|Secondary|Number of Bleeding Episodes|Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population: participants with basal FIX activity less than or equal to (<=) 1 percent (%) with real exposure days in diary at least 70% of planned exposure days for prophylaxis period, and without FIX inhibitor before or during study (no FIX inhibitor history at baseline; FIX inhibitor titer <0.6 Bethesda Unit [BU] during follow up).|||bleeding episodes|||Number
2756001|NCT00835068|Primary|Number of Participants With Events of Special Interest|Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX.|||participants|||Number
2756002|NCT00835068|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.|Year 3.5 up to 4.75|Safety population included all participants who received at least one dose of BeneFIX. Previously untreated participants were not evaluable for this outcome measure due to discontinuation prior to safety amendment.|||participants|||Number
2756003|NCT00835068|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.|Baseline up to Year 3.5|Safety population included all participants who received at least one dose of BeneFIX.|||participants|||Number
2756004|NCT00835042|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756005|NCT00835042|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756006|NCT00835042|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756007|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756008|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756009|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756010|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756011|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756012|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756013|NCT00835003|Secondary|Pediatric Admission and Morbidity||From birth until 2 years of age|||||||
2756014|NCT00835003|Secondary|Pediatric Admission and Morbidity||2 months post partum|||||||
2756015|NCT00835003|Secondary|Post Partum Depression||2 months|||||||
2756016|NCT00835003|Secondary|Maternal Satisfaction With Timing of Elective Caesarean Section||2 months|||||||
2756017|NCT00835003|Secondary|Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission||30 days|||||||
2756018|NCT00835003|Secondary|Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.||30 days|||||||
2756019|NCT00835003|Secondary|Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics||30 days|||||||
2756020|NCT00835003|Secondary|Neonatal Diagnoses||30 days|||||||
2756021|NCT00835003|Primary|Neonatal Admission After Elective Caesarean Section||48 hours||||participants|||Number
2756022|NCT00834990|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
2756023|NCT00834990|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
2756024|NCT00834990|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg/mL||Standard Deviation|Mean
2756025|NCT00834977|Secondary|AUC0-t - Benazaprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756026|NCT00834977|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2756027|NCT00834977|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
2756028|NCT00834977|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756029|NCT00834977|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756030|NCT00834977|Primary|Cmax - Benazepril|Bioequvialence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756031|NCT00834977|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
2756032|NCT00834977|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
2756033|NCT00834977|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg/mL||Standard Deviation|Mean
2756034|NCT00834964|Secondary|AUC0-t - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
2756035|NCT00834964|Secondary|AUC0-inf - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
2756036|NCT00834964|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng/mL||Standard Deviation|Mean
2756037|NCT00834964|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
2756038|NCT00834964|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
2756039|NCT00834964|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng/mL||Standard Deviation|Mean
2756040|NCT00834912|Secondary|t1/2|Apparent terminal elimination half-life (t1/2)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variable T1/2 of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.|||hours||Standard Deviation|Mean
2756041|NCT00834912|Secondary|Tmax|Time to maximum plasma concentration (Tmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.|||hours||Full Range|Median
2756042|NCT00834912|Primary|Cmax|Maximum plasma concentration (Cmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.|||ng/mL||Standard Deviation|Mean
2756043|NCT00834912|Primary|AUC(0-∞)|"The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL.~h=hours"|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variables AUC(0-∞) of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.|||ng.h/mL||Standard Deviation|Mean
2756044|NCT00834912|Primary|AUC(0-t)|Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.|||ng.h/mL||Standard Deviation|Mean
2756045|NCT00834899|Primary|Change in Platelet Count|Change in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).|Up to 35 days||||x 10^9/L||Full Range|Median
2756046|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Hospitalization|The duration of hospitalization will be defined as the period from randomization to the time an order for discharge from the hospital is written.|Up to 7 days|Intention to treat|||Days||Full Range|Median
2756047|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Acute Pain Episodes|"The duration of the pain episode will be defined as the time from randomization to termination of the pain episode. The pain episode will be considered terminated when the patient states that the crisis is resolved (defined as being ready to go home on oral analgesics) or all of the following criteria are met:~Pain relief (pain scores ≤ 40) maintained for at least 2 consecutive readings (assessed using a visual analog scale with measurements from 0 - 100, where 0 is no pain and 100 is worst imaginable pain).~No parenteral analgesics have been administered for at least 12 hours.~Ability to walk normally (unless he/she was unable to walk for some other reason prior to the crisis onset)."|Up to 7 days|Intention to treat|||Days||Full Range|Median
2756048|NCT00834899|Primary|1) Major Bleeding Episodes|Major bleeding episodes are defined as any episode, such as gastrointestinal bleeding or intracranial bleed that typically leads to hospitalization or other prolonged bleeding requiring a blood transfusion|Up to 35 days|Intention to treat|||participants|||Number
2756049|NCT00834886|Primary|To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid.|1 day after 2-week treatment ended||||Minutes||Standard Deviation|Mean
2756050|NCT00834886|Primary|To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 (very alert) to 9 (very sleepy, fighting sleep, effort to stay awake)."|1 day after 2-week treatment ended|All participants in the four arms|||units on a scale||Standard Deviation|Mean
2756051|NCT00834886|Primary|To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later.~Midnight is 0000; in the outcome measure table the value is given in minutes after midnight.~i.e. 530 equals 08:50 in the morning."|1 day after two-week treatment ends||||Minutes||Standard Deviation|Mean
2756052|NCT00834873|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756053|NCT00834873|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756054|NCT00834873|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756055|NCT00834834|Secondary|Number of Participants With Suicide Events|Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual's actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.|measured after 6 months of treatment||||participants|||Number
2756056|NCT00834834|Primary|Suicide Events|Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual's actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.|Measured after 6 months of treatment||||suicide events|||Number
2756057|NCT00834808|Secondary|t1/2|Apparent terminal elimination half-life|48 hours||||hours||Standard Deviation|Mean
2756058|NCT00834808|Secondary|Tmax|Time to maximum plasma concentration|48 hours||||hours||Full Range|Median
2756059|NCT00834808|Primary|Cmax|Maximum plasma concentration.|48 hours||||ng/mL||Standard Deviation|Mean
2756060|NCT00834808|Primary|AUC(0-inf)|Area under the plasma concentration versus time curve extrapolated to infinity. h = hours|48 hours||||ng.h/mL||Standard Deviation|Mean
2756061|NCT00834808|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measurable concentration.~h = hours"|48 hours||||ng.h/mL||Standard Deviation|Mean
2756062|NCT00834795|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756063|NCT00834795|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756064|NCT00834795|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756065|NCT00834756|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration (Per Participant) - Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756066|NCT00834756|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756067|NCT00834756|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756068|NCT00834743|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756069|NCT00834743|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756070|NCT00834743|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756071|NCT00834717|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Bl;ood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756120|NCT00834431|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756072|NCT00834717|Primary|Auc0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756073|NCT00834717|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756074|NCT00834678|Secondary|Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS||up to two years|Correlative studies to assess EGFR expression and gene amplification, were planned, but not collected because of early trial termination.||||||
2756075|NCT00834678|Secondary|Overall Survival (OS)||from time of study enrollment until death, for up to 2 years||||months||95% Confidence Interval|Median
2756076|NCT00834678|Secondary|Duration of Response (DR)||Up to two years||||months to progression||95% Confidence Interval|Median
2756077|NCT00834678|Secondary|Clinical Benefit Rate (CBR)||Up to two years|The data was not collected and analyzed||||||
2756078|NCT00834678|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to two years||||patients|||Number
2756079|NCT00834678|Primary|Progression-free Survival at 6 Months and 12 Months (Phase II)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to two years||||months||95% Confidence Interval|Mean
2756080|NCT00834678|Primary|Dose-limiting Toxicity (Phase I)||Up to two years||||patients|||Number
2756081|NCT00834678|Primary|Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)|28 day cycle included intravenous erlotinib on days 15-21.|Up to two years||||mg|||Number
2756082|NCT00834678|Primary|Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)|28 day cycle included intravenous bendamustine on days 1 and 2.|Up to two years||||mg/m^2|||Number
2756083|NCT00834652|Primary|Change of Beck Depression Inventory-II Scores Over 16 Weeks|Beck Depression Inventory-II (BDI) scores 0-63, minimum score =0, maximum score =63, Higher scores represent worse outcome. Baseline scores are compared to scores after treatment.|Measured at Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2756084|NCT00834639|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
2756085|NCT00834639|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
2756086|NCT00834639|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg/mL||Standard Deviation|Mean
2756087|NCT00834626|Secondary|Percentage of Participants Achieving Remission in Hypertension|Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication|1 year||||Percentage of Participants|||Number
2756088|NCT00834626|Primary|Percentage of Participants Having Remission of Type 2 Diabetes|The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped|One year||||Percentage of Participants|||Number
2756089|NCT00834626|Secondary|Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents|Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year|one year||||Percentage of Participants|||Number
2756090|NCT00834626|Secondary|Percentage of Participants Not Requiring Insulin|After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months|1 year||||Percentage of Participants|||Number
2756091|NCT00834613|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756092|NCT00834613|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756093|NCT00834613|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756094|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756095|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one completed subject could not be used to estimate AUC0-inf.|||ng*h/mL||Standard Deviation|Mean
2756096|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756097|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756098|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756099|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756100|NCT00834574|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756101|NCT00834574|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756102|NCT00834574|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756103|NCT00834561|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756104|NCT00834561|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756105|NCT00834561|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756106|NCT00834535|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756107|NCT00834535|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756108|NCT00834535|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756109|NCT00834522|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756110|NCT00834522|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756111|NCT00834522|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756112|NCT00834483|Secondary|Visual Analog Score, Cosmesis|"Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.~1 is an unacceptable or poor perspective in regards to wound cosmesis."|6 months|Power analysis described above|||units on a scale (1 is a low score)||Full Range|Mean
2756113|NCT00834483|Secondary|Cost-analysis|Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs|1 year|Power analysis was performed as above.|||Dollars||Standard Deviation|Mean
2756114|NCT00834483|Primary|Closure Time|We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.|6 months|A power analysis was performed based on mean closure times by the 2 surgeons and determined that a sample size of 23 patients in each group would provide 90% power to detect a 50% difference in closure time. To account for patients being lost to FU, we enrolled 29 to the traditional closure group and 31 to the barbed closure group|||Average time in minutes||Full Range|Mean
2756115|NCT00834444|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756116|NCT00834444|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756117|NCT00834444|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756118|NCT00834431|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756119|NCT00834431|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756121|NCT00834418|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756122|NCT00834418|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756123|NCT00834405|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose (Per Participant) - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756124|NCT00834405|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756125|NCT00834366|Secondary|t1/2|Apparent terminal elimination half-life|48 hours||||hours||Standard Deviation|Mean
2756126|NCT00834366|Primary|Cmax|Maximum plasma concentration|48 hours||||ng/mL||Standard Deviation|Mean
2756127|NCT00834366|Primary|AUC(0-Inf)|Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.|48 hours||||ng.h/mL||Standard Deviation|Mean
2756128|NCT00834366|Secondary|Tmax|Time to the maximum concentration|48 hours||||hours||Full Range|Median
2756129|NCT00834366|Primary|AUC(0-t)|Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.|48 hours||||ng.h/mL||Standard Deviation|Mean
2756130|NCT00834340|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756131|NCT00834340|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for one subject.|||ng*h/mL||Standard Deviation|Mean
2756132|NCT00834340|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756133|NCT00834288|Secondary|Plateau Time (T75%Cmax)|Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.|24 hours (day 5)||||hours||Standard Deviation|Mean
2756134|NCT00834288|Secondary|Half-value Duration (HVD)|Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.|24 hours (day 5)||||hours||Standard Deviation|Mean
2756135|NCT00834288|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)*100. It was calculated over 24 hours on day 5.~Where:~Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state."|24 hours (day 5)||||percentage of fluctuation||Standard Deviation|Mean
2756136|NCT00834288|Secondary|Percentage Peak-trough Fluctuation (% PTF)|"Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5.~Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24)."|24 hours (day 5)||||percentage of fluctuation||Standard Deviation|Mean
2756137|NCT00834288|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure over 24 hours (24h) at steady state on day 5.|24 hours (day 5)||||hours||Full Range|Median
2756138|NCT00834288|Secondary|Minimum Plasma Concentration at Steady State(Cmin,ss)|Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.|24 hours (day 5)||||ng/mL||Standard Deviation|Mean
2756139|NCT00834288|Secondary|Maximum Plasma Concentration at Steady State(Cmax,ss)|Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.|24 hours (day 5)||||ng/mL||Standard Deviation|Mean
2756140|NCT00834288|Primary|Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)|"Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5.~ss = steady state. AUCss is also known as AUCtau."|24 hours (day 5)||||ng*h/mL||Standard Deviation|Mean
2756141|NCT00834275|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756142|NCT00834275|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756143|NCT00834275|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756144|NCT00834249|Secondary|AUC0-t - O-desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756145|NCT00834249|Secondary|AUC0-inf - O-desmethylvenlafazine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756146|NCT00834249|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756147|NCT00834249|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756148|NCT00834249|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756149|NCT00834249|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756150|NCT00834236|Primary|Number of Participants With Accurate Diagnosis for Gastric Cancer|Normal subject group: number of the subjects with normal alpha 1-antitrypsin level in gastric juice Gastric cancer group: number of the subjects with elevated alpha 1-antitrypsin level in gastric juice|2 months||||participants|||Number
2756151|NCT00834210|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts(open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of lesions||Standard Deviation|Mean
2756152|NCT00834210|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
2756153|NCT00834210|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized)|||Scores on a scale||Standard Deviation|Mean
2756154|NCT00834210|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12|Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of Lesions||Standard Deviation|Mean
2756155|NCT00834197|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756156|NCT00834197|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756157|NCT00834197|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756158|NCT00834171|Primary|Mean Elevated Intraocular Pressure (IOP) During Treatment|Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.|55 days|Intent to treat, which included all patients in the study.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2756159|NCT00834132|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756160|NCT00834132|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756161|NCT00834132|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756162|NCT00834106|Secondary|Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update)|The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.|Up to 78 months|The population analyzed included participants 20 to 26 years of age at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
2756174|NCT00834067|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756163|NCT00834106|Secondary|Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update)|The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.|Up to 78 months|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
2756164|NCT00834106|Primary|Entire Study: Percentage of Participants Who Died|The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm|Up to approximately 90 months|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
2756165|NCT00834106|Primary|Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events|A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure.|Up to approximately 90 months|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
2756166|NCT00834106|Primary|Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.|Up to 6 months|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
2756167|NCT00834106|Primary|Base Study: Percentage of Participants With One or More Systemic Adverse Events|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.|Up to 15 days after any vaccination|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
2756168|NCT00834106|Primary|Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination.|Up to 15 days after any vaccination|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
2756169|NCT00834106|Primary|Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)|The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block.|Up to Month 78|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 16 and 18.|||Cases per 100 person-years of follow-up|person-years||Number
2756170|NCT00834106|Primary|Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)|The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.|From Day 1 until >=17 cases accumulate, up to Month 30|The population analyzed included participants 20 to 26 years old at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
2756171|NCT00834106|Primary|Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)|The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.|From Day 1 until >=25 cases accumulate, up to Month 30|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
2756172|NCT00834080|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|2 years (Baseline to end of study)|The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.|||participants|||Number
2756173|NCT00834067|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756175|NCT00834067|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756176|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756177|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756178|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756179|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756180|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756181|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756182|NCT00834041|Primary|Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.|||mL/h/kg||Standard Deviation|Mean
2756183|NCT00834041|Primary|Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.|||h*ng/mL||Standard Deviation|Mean
2756184|NCT00834041|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients|Blood pressure (BP) measurements were made with a mercury sphygmomanometer or an automated blood pressure measuring device. Sitting BP was measured 3 times at 2-3 minute intervals after the patient had been sitting for 5 minutes. Means of the 3 measurements were calculated. A negative change in BP indicates lowered BP.|Baseline to end of treatment (Day 9)|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients.|||mmHg||Standard Deviation|Mean
2756185|NCT00834041|Secondary|Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9|Blood samples (2 mL) for pharmacodynamics evaluation of plasma renin activity were drawn pre-dose and at 2 and 10 hours following the dose of study medication on Day 1 and at pre-dose and at 2, 10, and 24 hours post-dose on Day 8-9.|Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8-9|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients. Data was not available for all patients at all time points. For each time point, n = the number of subjects for whom data was available for each treatment group.|||ng/mL/h||Standard Deviation|Mean
2756186|NCT00834041|Primary|Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.|||ng/ml||Standard Deviation|Mean
2756187|NCT00833989|Secondary|Serum Levels of the S100β Protein|The serum sample for S100β collected on Day 1 (predose, 1, 6, 12 and 24 hour) and Day 5 and was analyzed for levels. Serum levels of S100β protein were recorded as log transformed values therefore the negative values are reported.|Day 1 (Pre-dose, Post dose 1, 6, 24 hour), Day 5|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||log (ug per liter)||Standard Deviation|Mean
2756188|NCT00833989|Secondary|Mean Change in Transcranial Magnetic Stimulations (TMS) Evaluated by Peak to Peak MEP by % Stimulation Level|TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motorneurons. Motor threshold was recorded as the lowest stimulus intensity (in percent) eliciting motor evoked potentials (MEPs). Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post -randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Percent change in stimulation||Standard Deviation|Mean
2756189|NCT00833989|Secondary|Mean Geriatric Depression Scale (GDS)|The short form GDS is a measure of depression developed specifically for use in elderly population and is sensitive and valid in the stroke population. The GDS was a participant-completed, 15 item questionnaire where each question referenced how the participant felt over the past week. Each question was answered with either a 'yes' or 'no' response. Of the 15 questions, 10 of them indicate depression when answered 'yes' (questions 2-4, 6, 8-10, 12, 14-15) and 5 indicate depression when answered 'no' (questions 1, 5, 7, 11, 13). Each question received a score of 1 point when the response was indicative of depression. Total score ranged from 0 to 15. the total score ranged from 0-15, where 0 implies no symptoms and higher score implies more severity of symptoms.|Day 5 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2756190|NCT00833989|Secondary|Mean Total Montreal Cognitive Assessment (MoCA) Score|MoCA was an examiner-administered, screening instrument with good validity, reliability, sensitivity and specificity for mild cognitive dysfunction. The MoCA had been studied in stroke participants and was recommended as a tool to monitor and measure cognitive changes post stroke as part of the 2006 National Institute of Neurological Disorders and Stroke - Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards. The MoCA assesses eight cognitive domains of visuospatial skills, executive function, language, attention, concentration, working memory, memory, and orientation. Participants were asked to complete 14 activities which the examiner scored according to the standardized scoring instructions. While there was no set time limit imposed on a participant. The total MoCA score ranges from 0-30, where 0= worsening and 30 reflects normal cognitive function.|Day 5 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2756191|NCT00833989|Secondary|Mean Barthel Total Score|The Barthel was a staff-assessed, 10 item activities of daily living index that evaluated feeding, grooming, dressing, excretion (bowels, bladder and toilet skills), bathing, and mobility (transfers, walking, stairs). The total Barthel score ranged from either 0-20 or 0-100 depending on which scoring algorithm was used where 0= unable or dependent and 20 or 100= independent to perform daily activities. For this study, the 100 point scoring algorithm was used. The Barthel takes approximately 5-10 minutes to complete with the participant.|Day 30 and 90|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2756192|NCT00833989|Secondary|Change From Baseline of National Institutes of Health Stroke Scale (NIHSS)|The NIHSS is a staff-assessed, 15 item, standardized, disease-specific, deficit scale which measures neurological impairment and is used to quantify participant status by measuring the severity of the stroke. The total NIHSS score ranged from 0 (No impairment) to 42 (severe impairment). Approximately 15 minutes were needed to complete the NIHSS. The NIHSS will be collected as part of the eligibility requirements to exclude participants who have a deficit that is either too mild or too severe. Only NIHSS certified study personnel recorded the NIHSS. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 10, 30 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2756193|NCT00833989|Secondary|Number of Participants With Modified Rankin Scale (mRS)|The mRS was a 6 point scale that measured participant handicap by evaluating limitations in activity and changes in lifestyle. The mRS was staff-assessed and scored from 0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderate severe disability, 5=severe disability (severe disability, bedridden, incontinent and requiring constant nursing care and attention). The structured interview was used to administer the mRS. The mRS took approximately 15 minutes to complete when using the structured interview. Number of participants with mRS were reported as per the category of the score.|Day 30 and 90|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2756194|NCT00833989|Secondary|Mean Change in Grip Strength on Affected Side|Grip strength is an objective measure of arm motor recovery in stroke participants and correlate with functional status and predict recovery. Grip strength was evaluated by a hand grip dynamometer. Three replicate trials was collected for both the impaired and normal hand, starting with the normal hand. Each trial was separated by a resting period of approximately 15-30 seconds. Participants was instructed to squeeze as hard as possible while using a standardized position of grip and the resulting dynamometer reading (in kg) was recorded. The grip strength measures was conducted within approximately 5 minutes. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Kg||Standard Deviation|Mean
2756195|NCT00833989|Secondary|Mean Change in Total Box and Blocks Transferred on Affected Side|The Box and Blocks test is an objective, gross manual dexterity test that is reliable and valid in individuals with upper limb impairments. Box and Blocks was a staff-assessed, participant completed test that required the participant to move small wooden blocks from one side of a partitioned box to the other. The score was determined by the number of blocks transferred within a 60 second time period. More number of blocks transferred as compared to Baseline indicated improvement. Both the impaired and normal limbs were tested, starting with the normal limb. The number of blocks transferred were recorded. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30, 60, 90 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Blocks||Standard Deviation|Mean
2756215|NCT00833976|Primary|Change in Triglycerides From Baseline to 16 Weeks||16 weeks|Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%|||mg/dL||Standard Deviation|Mean
2756196|NCT00833989|Secondary|Mean Change in Total Fugl-Meyer Motor (FM) Assessment|The FM assessment is a staff-assessed, disease specific, quantitative measure of impairment that is used to assess recovery of sensorimotor function post stroke. The FM is designed to assess the domains of motor function, balance, sensation and joint function. For this study, only the motor function domain was assessed. The motor domain scale takes approximately 30 minutes to complete and evaluates both the upper and lower extremities by direct observation of the participant's performance of 50 items that measure movement, coordination, and reflex action. Each item was scored from 0-2 for a minimum total score of 0 (hemiplegia) and a maximum total score of 100 (normal motor performance). Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
2756197|NCT00833989|Secondary|Mean Change in Berg Balance Scale (BBS) Total Score|BBS is a performance based measure of balance. It is reliable, valid and responsive to change in the stroke population. BBS is a staff-assessed measure that requires the participant to perform 14 activities that evaluate ability to maintain balance. The BBS typically takes 10-15minute to complete. Participants were not allowed to use assistive devices while performing the activities. Each activity was evaluated by direct observation of the participant's performance and was scored on a 5-point ordinal scale (0-4) where a score of 0 represents inability to perform the activity and a score of 4 represents independence in the activity. The minimum total score on the BBS was 0 and maximum was 56. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
2756198|NCT00833989|Secondary|Mean Change in Mean Gait Velocity|Gait velocity is an objective, quantitative, reliable, valid and sensitive measure of lower extremity motor recovery in the stroke population. Changes in gait velocity correlates with physical functioning and quality of life. Gait velocity was assessed over a level, indoor 10 meter distance. The time (in seconds) it takes the participant to travel the 10 meter distance was recorded. Participants was asked to walk at their usual or normal pace and may use their normal assistive devices. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30, 60, 90, 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Meters/second||Standard Deviation|Mean
2756199|NCT00833989|Secondary|Mean Clearance of GSK249320|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The clearance was calculated as Dose/ AUC(0-inf).|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||mL/hour/killogram (kg)||Standard Deviation|Mean
2756200|NCT00833989|Secondary|Mean Terminal Phase Rate Constant ( Lambda-Z)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||1/ hour||Standard Deviation|Mean
2756201|NCT00833989|Secondary|Mean Terminal Phase Half-life (t1/2)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The apparent t1/2 obtained as the ratio of natural log (ln)^2/ lambda-Z, where lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||Day||Standard Deviation|Mean
2756202|NCT00833989|Secondary|Mean Time of Occurrence of Cmax (Tmax) and Time of Last Observed Quantifiable Concentration (Tlast)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Tmax and tlast were determined directly from the raw concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||hour||Standard Deviation|Mean
2756203|NCT00833989|Secondary|Mean Maximum Observed Concentration (Cmax) and Last Observed Quantifiable Concentration (Ct)|The pharmacokinetic parameters were calculated by standard non- compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Cmax and Ct were determined directly from the raw concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetic population. Only those participants with data available for analysis were analyzed.|||microgram (ug) per mL||Standard Deviation|Mean
2756212|NCT00833989|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 112 days|All Subjects population was defined as all participants who receive at least one dose of study medication.|||Participants|||Count of Participants
2756204|NCT00833989|Secondary|Mean Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC 0-inf) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. AUC0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC(0-inf) were calculated, where data permit, as the sum of area under the concentration-time curve over the dosing interval from 0 to Day 10 ±1 day (AUC0-10d) and C10d/z, where C10d is the observed plasma concentration at day 10 and z is the terminal phase rate constant calculated after the second dose.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetic population comprised of participants from the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants with data available for analysis were analyzed.|||Hour*mg/millilitre (mL)||Standard Deviation|Mean
2756205|NCT00833989|Secondary|Number of Participants With Positive Antibodies to GSK249320|Presence of antibodies to GSK249320 were assessed in serum samples of participants using immunoelectro-chemiluminescent assay. Number of participants with positive antibodies to GSK249320 were reported. Only visits where the true positive antibody detection was observed were reported.|Day 1, 5, 10, 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2756206|NCT00833989|Primary|Number of Participants With Abnormal Hematological Parameters|The clinical chemistry parameters analyzed were white blood cell count, neutrophil count, hemoglobin, platelet count, lymphocytes. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal hematology findings at specified visit were reported.|Up to Day 112|All Subjects population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Participants|||Count of Participants
2756207|NCT00833989|Primary|Number of Participants With Abnormal Clinical Chemistry Parameters|The clinical chemistry parameters analyzed were albumin, calcium, creatinine, glucose, potassium, sodium, total CO2, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal clinical chemistry findings at specified visit were reported.|Up to Day 112|All Subjects population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Participants|||Count of Participants
2756208|NCT00833989|Primary|Number of Participants With White Matter Changes and Demyelination Assessed by Magnetic Resonance Imaging (MRI)|Whole brain MRI scans were performed by appropriately qualified personnel at those specified visits (Day 1, 10 and 60 or at early withdrawal [if participant withdrew from study before Day 60 MRI]). Required pulse sequences of diffusion weighted imaging (DWI), T1, and T2 FLAIR was performed to measure lesion volume and to look for the presence of any new acute inflammatory lesions. The investigator or other medically qualified study team member evaluated the Day 10 and 60 scans for any new abnormalities or clinically significant worsening. Digital data for each MRI was sent to a central MRI laboratory for an over-read of the MRI scan and calculation of the lesion volume. Number of participants with change in white matter and demyelination on Day 10 compared to Day 1, Day 60 compared to Day 1 and Day 60 compared to Day 10 were reported.|Up to Day 60|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2756209|NCT00833989|Primary|Number of Participants With Nerve Conduction Testing (NCT) Values|NCT (electrode placement technique) of sensory and motor function was performed on the unaffected side (i.e., side that is not affected by the stroke) by appropriately qualified personnel at specified visits (Day 5 and 30 and at early withdrawal). Qualified technician performed the testing; however the same neurologist interpreted the NCT data within a single participant. Both upper and lower extremity nerves were tested and the data was recorded. Number of participants with normal and abnormal NCT data were reported.|Day 5 and 30 and at early withdrawal|All Subject population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2756210|NCT00833989|Primary|Number of Participants With Electrocardiogram (ECG) Values Outside Range of Potential Clinical Importance|Single 12-lead ECGs was obtained. The standard ECG criteria of potential clinical importance were uncorrected QT interval <300 and >600 milliseconds (msec), absolute QTc interval >500 msec, increase from Baseline QTc >60 msec, RR Interval <90 and >2000 msec, PR Interval <110 and >220 msec, QRS Interval <75 and >110 msec. The number of participants with potentially clinically significant ECG abnormality were reported.|Up to 112 days|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2756211|NCT00833989|Primary|Number of Participants With Vital Signs Changes of Potential Clinical Importance|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (SBP) (<85 and >200 millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (<45 and >110 mmHg) and heart rate (HR) (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 112 days|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2756213|NCT00833976|Secondary|Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)|At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).|16 weeks|All participants who took at least one dose of the study medication were included in the analyzable population.|||Participants|||Count of Participants
2756214|NCT00833976|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks||16 weeks|Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%|||mg/dL||Standard Deviation|Mean
2756216|NCT00833937|Primary|AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756217|NCT00833937|Primary|AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756218|NCT00833937|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756219|NCT00833924|Primary|Patients With Device Failures|"Device success at 12-month is defined as:~Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm."|12-month|There were 5 patients died, and 2 patients withdrew.|||participants|||Number
2756220|NCT00833924|Primary|Patients With Major Adverse Events (MAE)|MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.|30-day|1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).|||participants|||Number
2756221|NCT00833911|Primary|Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation|Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population|6 months and 12 months|"All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months.~6-months safety: patients who completed at least 175 days on treatment.~12-months safety: patients who completed at least 350 days on treatment."|||participants|||Number
2756222|NCT00833898|Secondary|Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)|Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
2756223|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 10 (IL-10)|Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
2756224|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 4 (IL-4)|Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
2756225|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 6 (IL-6)|Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 11). Caregiver Intervention group: missing responses (n = 4).|||ln(pg/mL)||95% Confidence Interval|Mean
2756226|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)|Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
2756227|NCT00833898|Secondary|Plasma C-reactive Protein (CRP)|Plasma c-reactive (CRP) is an acute phase reactant that has been found to be predictive of cardiovascular disease. Is is also an inflammatory marker that will be assessed using high sensitivity CRP assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 6).|||ln(mg/L)||95% Confidence Interval|Mean
2756228|NCT00833898|Secondary|Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity|The activity of natural killer (NK) cells is modified by psychosocial and behavioral states (Cacioppo et al., 1998; Irwin et al., 1991; Kiecolt-Glaser et al., 1991; Kiecolt-Glaser, 1999; Kiecolt-Glaser, McGuire, Robles, et al., 2002a; Kiecolt-Glaser, McGuire, Robles, et al., 2002b). Natural cytotoxicity will be determined toward K562 target cell lines as previously described (Laudenslager et al., 1998; Scanlan, et al., 1995). Percent lysis at each effector to target ratio will be found from the median value of each triplicate determination and from which the percent lysis/NK + cell will be determined for 20% lysis (lytic units/NK+ cell).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||ln(% Lysis/NK+ Cell)||95% Confidence Interval|Mean
2756229|NCT00833898|Secondary|Area Under the Curve for Salivary DHEA (AUCd)|The AUCd will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total DHEA released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).|||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
2756230|NCT00833898|Secondary|Area Under the Curve for Salivary Cortisol (AUCc)|The AUCc will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total cortisol released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).|||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
2756307|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Screening Visits, up to 45 days prior to Baseline Visit. Specifically, Screening Visit 1 occurred between day -45 and -4; Screening Visit 2 occurred between day -43 and -2.||||mg/dL||Standard Deviation|Mean
2756231|NCT00833898|Secondary|The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)|The SlopeD has been noted to be affected by affective disorders such as depression. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and +10 hours after awaking to characterize the diurnal change in salivary DHEA.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 15).|||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
2756232|NCT00833898|Secondary|The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)|The SlopeC has been noted to be affected by stressful experiences. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and 10 hours after awaking to characterize the diurnal change in salivary cortisol (SlopeC).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 12). Caregiver Intervention group: missing responses (n = 12).|||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
2756233|NCT00833898|Secondary|Stress as Measured by the Impact of Events Scale (IES)|The Impact of Events Scale (IES), a widely accepted measure for evaluating intrusive thoughts regarding an event or situation. The scale consists of 15 items (7 measuring intrusive thoughts and 8 measuring avoidance) scored on a 5-point Likert Scale. Minimum score (best value)=0. Maximum score (worst value)=75. Scores over 20 indicate significant levels of PTS-like symptoms. The IES is anchored to the caregiving experience.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).|||units on a scale||95% Confidence Interval|Mean
2756234|NCT00833898|Secondary|Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).|||units on a scale||95% Confidence Interval|Mean
2756235|NCT00833898|Secondary|Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Role emotional, social functioning and mental health contribute to mental component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).|||units on a scale||95% Confidence Interval|Mean
2756236|NCT00833898|Secondary|Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where scores greater than 5 indicate poor sleep quality.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
2756237|NCT00833898|Secondary|Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)|The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale refers to the caregiver. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
2756238|NCT00833898|Secondary|Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)|POMS stands for the Profile of Mood States. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1) tension-anxiety, 2) depression-dejection, 3) anger-hostility, 4) fatigue-inertia, 5) vigor-activity and 6) Confusion-bewilderment. A Total Mood Disturbance (TMD) can be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. The range for the Total Mood Disturbance (TMD) score is 0 - 200, with higher score indicating more mood disturbance.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
2756239|NCT00833898|Secondary|State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)|The State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
2756240|NCT00833898|Secondary|Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)|The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report 20-item scale designed to measure current depressive symptoms. Scores range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 2).|||units on a scale||95% Confidence Interval|Mean
2756340|NCT00833521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756241|NCT00833898|Primary|Physiological - Cortisol Awakening Response (CAR)|Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 15). Caregiver Intervention group: missing responses (n = 15).|||ln(nmol/L)||95% Confidence Interval|Mean
2756242|NCT00833898|Primary|Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).|||units on a scale||95% Confidence Interval|Mean
2756243|NCT00833859|Secondary|Number of Participants With Overall Survival|We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
2756244|NCT00833859|Secondary|Number of Participants With Objective Response|Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
2756245|NCT00833859|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).|Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
2756246|NCT00833859|Primary|Number of Participants With Resectability|The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
2756247|NCT00833833|Primary|Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off|"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
2756248|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off|"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"ITT population.~Data collection is ongoing and future data results will be included as available."|||weeks||95% Confidence Interval|Median
2756249|NCT00833833|Secondary|Phase 2: Time to Response as of the 01 April 2011 Cut-off|"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Responders (participants achieving CR or PR) from ITT population.~Data collection is ongoing and future data results will be included as available."|||weeks||Full Range|Median
2756250|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off|"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome."|up to 70 weeks|"Responders (participants with a complete response or partial response) from the ITT population.~Data collection is ongoing and future data results will be included as available."|||weeks||95% Confidence Interval|Median
2756259|NCT00833794|Secondary|Time to Response|Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||days||95% Confidence Interval|Median
2756251|NCT00833833|Secondary|Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off|"IRAC used EBMT criteria to assess myeloma response:~Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)~Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others~Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others~Stable Disease (SD)- not MR or progressive disease (PD)~Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other~Not Evaluable (NE).~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
2756252|NCT00833833|Secondary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 70|"Safety population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
2756253|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off|"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.~Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 126|"Safety population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
2756254|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 104|"Safety population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
2756255|NCT00833833|Primary|Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off|"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.~Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."|||weeks||95% Confidence Interval|Median
2756256|NCT00833833|Primary|Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1|"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event"|Up to Day 28 (Cycle 1)|Safety population|||participants|||Number
2756257|NCT00833794|Secondary|Discontinuation Due to Adverse Events|The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
2756258|NCT00833794|Secondary|Discontinuation Due to Lack of Efficacy|The number of patients who discontinued due to lack of efficacy was reported.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
2756298|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756299|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756260|NCT00833794|Secondary|Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|week 12|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
2756261|NCT00833794|Secondary|Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
2756262|NCT00833794|Secondary|WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
2756263|NCT00833794|Secondary|WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
2756264|NCT00833794|Secondary|Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)|Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
2756265|NCT00833794|Secondary|Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain|6 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
2756266|NCT00833794|Primary|Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
2756267|NCT00833781|Secondary|IL2 and IFN Gamma Production||Baseline to week 14|Results from these assays were too variable to be interpretable.||||||
2756268|NCT00833781|Primary|Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef|Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.|Baseline and 14 weeks||||fold ratio||Full Range|Median
2756269|NCT00833781|Secondary|T Cell Proliferation||Baseline to week 14||||fold change||95% Confidence Interval|Mean
2756270|NCT00833781|Primary|Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)|Number of participants with grade 3 or 4 adverse events related to vaccination|After vaccination||||participants|||Number
2756271|NCT00833755|Primary|Change in Duration of Supra-threshold Pain Tolerance|"Using QST, we detected the duration (seconds) of tolerance to supra-threshold heat pain stimulation. In this test, subjects were asked to tolerate, as long as he or she could, heat stimulation preset at 47°C for a maximum of 60 seconds. They were given the computer mouse to stop the test if they reached their limit before 60 seconds. If they stopped the test before the 60 seconds, the time that they stopped it was recorded.~This test was repeated 3 times and an average duration was calculated. The duration could range from a minimum of 0 seconds to a maximum of 60 seconds."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.|||seconds||Standard Deviation|Mean
2756272|NCT00833755|Primary|Change in Temperature of Pain Tolerance|"Using QST, we measured the change in pain tolerance which was the maximum thermal stimulation intensity (in °C) tolerable. In this test, the subject was instructed to press the computer mouse to stop stimulation when the thermode reached the maximal tolerable temperature.~This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.|||Degrees Celsius||Standard Deviation|Mean
2756300|NCT00833690|Secondary|Serum Urate|From blood sample drawn before taking study drug that day|Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756301|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756273|NCT00833755|Primary|Change in Temperature of Pain Threshold|"We measured the change in pain threshold using Quantitative Sensory Testing (QST). QST refers to a set of quantitative testing of individual responses to mechanical, thermal, and/or electrical stimulation. In this study, pain threshold was the thermal stimulation intensity (in°C) first perceived as painful. To measure this, a contact thermode was attached onto the dorsal surface of the forearm. By pressing a computer mouse button, each subject was able to stop stimulation when they first perceived a painful stimulation from the thermode as the temperature increased 1°C/s.~This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.|||Degrees Celsius||Standard Deviation|Mean
2756274|NCT00833703|Primary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.|Up to a maximum of 6 months|The analysis was performed on the same population as previously (i.e. ITT population).|||participants|||Number
2756275|NCT00833703|Secondary|Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths|"Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.~Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first)."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.|||participants|||Number
2756276|NCT00833703|Primary|Number of Participants With Bleeding Events|"All bleeding events experienced during the study period were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.|||participants|||Number
2756277|NCT00833690|Secondary|Change in Serum Urate|Change from Last Visit on Study Drug|Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)||||mg/dL||Standard Deviation|Mean
2756278|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])||||mg/dL||Standard Deviation|Mean
2756279|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 12 from Baseline (i.e., between -45 days and +24 months)||||mg/dL||Standard Deviation|Mean
2756280|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 11 from Baseline (i.e., between -45 days and +21 months)||||mg/dL||Standard Deviation|Mean
2756281|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 10 from Baseline (i.e., between -45 days and +18 months)||||mg/dL||Standard Deviation|Mean
2756282|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 09 from Baseline (i.e., between -45 days and +15 months)||||mg/dL||Standard Deviation|Mean
2756283|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 08 from Baseline (i.e., between -45 days and +12 months)||||mg/dL||Standard Deviation|Mean
2756284|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 07 from Baseline (i.e., between -45 days and +9 months)||||mg/dL||Standard Deviation|Mean
2756285|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 06 from Baseline (i.e., between -45 days and +6 months)||||mg/dL||Standard Deviation|Mean
2756286|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 05 from Baseline (i.e., between -45 days and +12 weeks)||||mg/dL||Standard Deviation|Mean
2756287|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 04 from Baseline (i.e., between -45 days and +9 weeks)||||mg/dL||Standard Deviation|Mean
2756288|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 03 from Baseline (i.e., between -45 days and +6 weeks)||||mg/dL||Standard Deviation|Mean
2756289|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 02 from Baseline (i.e., between -45 days and +4 weeks)||||mg/dL||Standard Deviation|Mean
2756290|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 01 from Baseline (i.e., between -45 days and +2 weeks)||||mg/dL||Standard Deviation|Mean
2756291|NCT00833690|Secondary|Serum Urate|From blood sample drawn a month after stopping study drug|Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit||||mg/dL||Standard Deviation|Mean
2756292|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756293|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756294|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756295|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756296|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756297|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
2756308|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Males)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks||||percentage of baseline serum urate||Standard Deviation|Mean
2756309|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Females)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks||||percentage of baseline serum urate||Standard Deviation|Mean
2756310|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (All Patients)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks||||percentage of baseline serum urate||Standard Deviation|Mean
2756311|NCT00833690|Secondary|CSF Urate (Males)||12 weeks||||mcg/dL||Standard Deviation|Mean
2756312|NCT00833690|Secondary|CSF Urate (Females)||12 weeks||||mcg/dL||Standard Deviation|Mean
2756313|NCT00833690|Secondary|CSF Urate (All Patients)|Urate concentration in cerebrospinal fluid (CSF)|12 weeks||||mcg/dL||Standard Deviation|Mean
2756314|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to AEs, and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|24 months||||percentage of participants|||Number
2756315|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|6 months||||percentage of participants|||Number
2756316|NCT00833664|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756317|NCT00833664|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756318|NCT00833664|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756319|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who received tadalafil 2.5 mg in the double-blind study period and did not respond to treatment in that treatment period, who have at least 1 baseline observation and who took at least 1 dose of tadalafil 5 mg in the open-label period followed by at least 1 intercourse attempt.|||percentage successful attempts||Standard Deviation|Mean
2756320|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation, who took tadalafil 5 mg during the double-blind treatment period, and who took at least 1 dose of tadalafil 5 mg followed by at least 1 intercourse attempt during the open-label period.|||percentage successful attempts||Standard Deviation|Mean
2756341|NCT00833521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756342|NCT00833521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756321|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage successful attempts||Standard Deviation|Mean
2756322|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage successful attempts||Standard Deviation|Mean
2756323|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts|"Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? Data are presented as the proportion of intercourse attempts for which participants answered yes relative to the total number of intercourse attempts. Total number of attempts = TNA."|14 days during double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of total number of attempts|||Number
2756324|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses|"Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a yes response to the sexual encounter profile diary question 3: Did your erection last long enough for you to have successful intercourse? Data are based on participants who responded yes. For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy."|4 days double-blind period|Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||days||Standard Error|Median
2756325|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 5: Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
2756326|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 4: Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
2756327|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 3: Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
2756328|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 2: Were you able insert your penis into your partner's vagina? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
2756329|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 1: Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
2756330|NCT00833638|Primary|Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3|"Cumulative percentage of participants achieving successful intercourse, as measured by yes responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse."|4 days during double-blind period|Modified intent-to-treat population consisting of all participants who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||cumulative percentage of participants|||Number
2756331|NCT00833586|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756332|NCT00833586|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756333|NCT00833586|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756334|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.|Up to Day 63|"Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."|||Percentage of participants|||Number
2756335|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible|Up to Day 63|"Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."|||Percentage of participants|||Number
2756336|NCT00833560|Secondary|Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.|||Participants|||Number
2756337|NCT00833560|Primary|Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).|||Participants|||Number
2756338|NCT00833547|Primary|Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography|2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)|during two nights in an inpatient Clinical Research Center||||spindles per minute during Stage 2 sleep||Standard Deviation|Mean
2756339|NCT00833547|Primary|Overnight Change on Finger Tapping Task|"The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) as quickly and accurately as possible for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning."|Train on Day 3 and Test on Day 4 of study (experimental nights)||||percent change||Standard Deviation|Mean
2756343|NCT00833482|Secondary|Number of Participants With Abnormalities in Vital Signs||Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
2756344|NCT00833482|Secondary|Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator|volt=voltage; LVH=left ventricular hypertrophy|Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
2756345|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If <.85*LLN or >1.15*ULN or ULN or if preRX<LLN, use <0.85*preRX or >ULN; if preRX>ULN, use >1.15*preRX or <LLN. Lymphocytes, relative: If <0.85*LLN or >1.15*ULN, or if preRX <LLN, use <0.85*preRX or >ULN; if preRX >ULN, use >1.15*preRX or <LLN. Blood, urine: If >= 2+, or if preRX >=1+, use >=2*preRX. White blood cells, urine: If >=2+, or if preRX >=2+, use >=4+. Red blood cells, urine: If >=2+ or if preRX >=2+, use >=4+. Not all categories were evaluated for each arm.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
2756346|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Serum Chemistry Test Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If >1.25*ULN, or if preRX>ULN, use >1.25*preRX. Total and direct bilirubin: If >1.1*ULN or if preRX>ULN, use >1.25*preRX. Creatinine: If >1.33*preRX. Serum glucose, fasting: If preRX<LLN, use <.8*preRX or >ULN; if preRX>ULN, use >2*preRX or <LLN. Creatinine kinase: If >1.5*ULN or preRX>ULN, use >1.5*or preRX. Lactose dehydrogenase: If >1.25*ULN or preRX>ULN, use >1.5*preRX.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
2756347|NCT00833482|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 to 31 (discharge), continuously|All participants who received study drug.|||Participants|||Number
2756348|NCT00833482|Secondary|AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2756349|NCT00833482|Primary|AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2756350|NCT00833482|Primary|Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2756351|NCT00833482|Primary|Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||Hours||Full Range|Median
2756352|NCT00833482|Secondary|Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||Hours||Full Range|Median
2756353|NCT00833482|Secondary|Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2756354|NCT00833482|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2756355|NCT00833482|Primary|Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||Hours||Full Range|Median
2756436|NCT00832650|Secondary|Mean Number of Stools Per Day|Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||stools||Standard Deviation|Mean
2756356|NCT00833482|Primary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)|EM participants are those with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2756357|NCT00833469|Secondary|Change in Beck Anxiety Inventory (BAI)|Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.|||units on a scale||Standard Deviation|Mean
2756358|NCT00833469|Secondary|Change in Edinburgh Postnatal Depression Scale (EPDS)|The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.|||units on a scale||Standard Deviation|Mean
2756359|NCT00833469|Primary|Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.|||units on a scale||Standard Deviation|Mean
2756360|NCT00833443|Post-Hoc|End of Treatment Methamphetamine Abstinence||12 weeks||||participants|||Number
2756361|NCT00833443|Secondary|Treatment Retention||12 weeks||||days||Standard Deviation|Mean
2756362|NCT00833443|Primary|End of Treatment Methamphetamine Abstinence|Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)|12 weeks||||participants|||Number
2756363|NCT00833443|Primary|Treatment Effectiveness Score|The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)|12 weeks||||urine drug screens||Standard Deviation|Mean
2756364|NCT00833417|Secondary|Percentage of Patients With Absence of Residual Basal Cell Carcinoma (BCC) in Patients With Locally Advanced BCC|In patients with locally advanced BCC, the histopathological effect of vismodegib was determined in tissue biopsies obtained at baseline and following vismodegib treatment. Reported are the percentage of patients with pathology confirmed BCC in baseline biopsy who had an absence of residual BCC post-baseline as assessed by an independent pathological review.|From baseline through end of the study, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma. Only locally advanced BCC patients with available post-baseline biopsy assessed by an independent pathologist were included in the analysis.|||Percentage of participants|||Number
2756365|NCT00833417|Secondary|Change From Baseline in Short Form 36 (SF-36) Health Survey Scores|The SF-36 Health Survey (Version 2) uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline, Week 12, Week 24, and at the end of the study or early termination visit, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Units on a scale||95% Confidence Interval|Mean
2756366|NCT00833417|Secondary|Overall Survival|Overall survival was defined as the time from the initial dose of vismodegib until death from any cause.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Months||95% Confidence Interval|Median
2756367|NCT00833417|Secondary|Progression-free Survival (PFS) Determined by the Independent Review Facility|PFS was defined as the time from start of treatment to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Months||95% Confidence Interval|Median
2756368|NCT00833417|Secondary|Duration of Objective Response (OR) Determined by the Independent Review Facility|Duration of OR was defined as the time from the initial CR or PR to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Months||95% Confidence Interval|Median
2756437|NCT00832650|Secondary|Time to Gastric Emptying|Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12: 2 hours, 4 hours|ITT included all randomized subjects. Imputation by overall mean for missing data.|||minutes||Standard Deviation|Mean
2756369|NCT00833417|Primary|Objective Response (OR) Determined by the Independent Review Facility|OR=complete (CR) or partial response (PR). Metastatic-CR:Disappearance of all targets. PR:≥30% decreased sum of longest diameter (SLD) of targets compared to baseline (B). Locally advanced-Response=No progressive disease (PD) and ≥30% decreased SLD from baseline (radiography [R]) or ≥30% decreased SLD from B (externally visible dimension [EVD]) or completely resolved ulceration. CR:Response with no residual BCC on tumor biopsy (otherwise response was PR). PD:Any of ≥20% increased SLD from nadir (R or EVD), new ulceration, new lesions (R or physical exam) or non-target lesion progression by R.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Percentage of participants||95% Confidence Interval|Number
2756370|NCT00833365|Secondary|Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration||1 and 6 hours|Due to early termination of the study, labs were not analyzed.||||||
2756371|NCT00833365|Primary|Number of PDA Closures Related to Treatment With Ibuprofen|Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.|Within 48 hrs of ibuprofen round|Premature infants born at 23+3 weeks to 29+4 weeks with positive patent ductus arteriosus on cardiac echogram were randomized to early or late treatment with ibuprofen. 2 babies which had been originally randomized to the late treatment arm never got ibuprofen and are not included in analysis.|||closures related to treatment|||Number
2756372|NCT00833261|Secondary|Number of Participants With Acute and Late Toxicities|Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.|6 months within the end of treatment||||Participants|||Count of Participants
2756373|NCT00833261|Primary|Progression Free Survival (PFS)|The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.|2 year from the date of enrollment||||percentage of participants||95% Confidence Interval|Number
2756374|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety analysis set.|||participants|||Number
2756375|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety analysis set.|||participants|||Number
2756376|NCT00833248|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||scores on a scale||Standard Deviation|Mean
2756377|NCT00833248|Secondary|Change From Baseline in Serum Oestradiol Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||nanogram per deciliter||Full Range|Median
2756378|NCT00833248|Secondary|Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||nanograms per milliliter||Full Range|Median
2756379|NCT00833248|Secondary|Change From Baseline in Serum Testosterone Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||nanograms per milliliter||Full Range|Median
2756380|NCT00833248|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||scores on a scale||Standard Deviation|Mean
2756381|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, OC.|||milliliter||Standard Deviation|Mean
2756382|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis.|||milliliter||Standard Deviation|Mean
2756403|NCT00833053|Primary|Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28|The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.|Baseline, Week 28||||Participants|||Number
2756438|NCT00832650|Secondary|Colonic Filling at 6 Hours|A surrogate marker of small bowel transit time.|Day 12|ITT included all randomized subjects. Imputation by overall mean for missing data.|||percentage||Standard Deviation|Mean
2756383|NCT00833105|Secondary|Active Motion Test - Wrist|"Tracking task for the wrist, i.e., flexing (i.e., pull with the front of the hand) and extending (i.e., pushing with the back of the hand). The participant tracks a target box on a video screen by actively moving the hand at the wrist, first in the extension direction, then flexion, and finally extension again. The participant's wrist position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The Pre-training Score is the average score obtained during the first 3 days of training, and the Post-training Score is average score obtained during the last 3 days of training."|Prior to training (baseline), after each of 25 training sessions (about 3 times/week)|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Seconds|Upper Limbs|Standard Deviation|Mean
2756384|NCT00833105|Secondary|Active Motion Test - Fingers/Thumb|"Tracking task for the thumb and finger, i.e., opening and closing the hand. The participant tracks a target box on a video screen by actively moving the thumb and fingers, first in the opening direction, then closing, and finally opeining again. The participant's thumb-and-finger position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The Pre-training Score is the average score obtained during the first 3 days of training, and the Post-training Score is average score obtained during the last 3 days of training."|Prior to training (baseline), after each of 25 training sessions (about 3 times/week)|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Seconds|Upper Limbs|Standard Deviation|Mean
2756385|NCT00833105|Secondary|Strength Test - Wrist Flexion|"Maximum strength in flexion direction~Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training."|Prior to training (baseline), after each of 25 training sessions (about 3 times/week)|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Newton*meters|Upper Limbs|Standard Deviation|Mean
2756386|NCT00833105|Secondary|Strength Test - Wrist Extension|"Maximum wrist strength in extension~Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training."|Prior to training (baseline), after each of 25 training sessions (about 3 times/week)|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Newton*meters|Upper Limbs|Standard Deviation|Mean
2756387|NCT00833105|Secondary|Strength Test - Thumb/Fingers Flexion|"Maximum strength of Thumb/fingers in Flexion~Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training."|Prior to training (baseline), after each of 25 training sessions (about 3 times/week)|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Newton*meters|Upper Limbs|Standard Deviation|Mean
2756388|NCT00833105|Secondary|Strength Test - Thumb/Finger Extension|"Maximum strength of thumb-and-fingers in extension.~Pre-training score is average of a total of 3 scores, including 1 score from each of the first 3 days of training. Post-training score is average of a total of 3 scores, including 1 score from each of the last 3 days of training."|Prior to training (baseline), after each of 25 training sessions (about 3 times/week)|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Newton*meters|Upper Limbs|Standard Deviation|Mean
2756389|NCT00833105|Secondary|Capabilities of Upper Extremity Instrument|"Subjective questionnaire of participants' self-perceptions of upper limb function that contains 17 questions relating to the use of the right upper limb, the same 17 relating to the use of the lower upper limb, plus two additional questions relating to bimanual function. Responses to each item of the questionnaire has a range of 1 (i.e., totally limited) to 7 (i.e., not at all limited). A total cumulative score used for the study is based on the sum of the responses to all 34 questions (i.e., 16 right arm, 16 left arm, 2 both arms), and therefore has a cumulative score range of 32 - 224, with higher scores indicating more function."|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||units on a scale|Upper Limbs|Standard Deviation|Mean
2756390|NCT00833105|Secondary|Modified Ashworth Scale|Measurement of joint stiffness (tone/spasticity). Score is based on sum of MAS value for 4 muscle groups: (1) Wrist/finger flexors, (2) Wrist/finger extensors, (3) elbow flexors, and (4) elbow extensors. Each muscle group and direction is score on a scale of 0 (no increase in muscle tone) to 5 (rigid), with a score of 2 used instead of 1+. A single overall score representing the sum of all 4 muscle groups and directions is used and has a range of 0-20 with higher scores representing more severe impairment.|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||units on a scale|Upper Limbs|Standard Deviation|Mean
2756391|NCT00833105|Secondary|Van Lieshout Hand Function Test for Tetraplegia- Short Version|Measures the functional movement in the upper limb of people with cervical spinal cord injury. The short version of this test includes a total of 10 different functional tasks to be performed by the subject with the upper limb. For example, one task is to reach and pick up a filled Coke bottle, set it down, and then replace it in its original position. Each task is scored on a scale of 0-5, 0 representing inability to perform the task and 5 representing normal movement. A single, total score is calculated as the sum of the scores on the 10 tasks, and therefore, has an overall range of 0-50, with higher scores representing better performance.|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||units on a scale|Upper Limbs|Standard Deviation|Mean
2756421|NCT00832767|Secondary|Time to Cannulization|Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.|Day 0||||minutes||Standard Deviation|Mean
2756392|NCT00833105|Secondary|ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick|Measures the subject's sensory perception, with eyes closed, of a light prick of a safety pin produced by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||units on a scale|Upper Limbs|Standard Deviation|Mean
2756393|NCT00833105|Secondary|ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch|Measures the subject's sensory perception, with eyes closed, of a light touch by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||units on a scale|Upper Limbs|Standard Deviation|Mean
2756394|NCT00833105|Secondary|ASIA Motor Key Muscles|ISNCSCI Assessment of motor function (upper limb only). Scores on a scale ranging from 0 (i.e., total paralysis) - 5 (i.e., full range of motion) for each of 5 upper limb muscle groups. Total score represents the overall level of the upper limb impairment and represents the sum of the 5 scores from the 5 upper limb muscle groups. Accordingly, the total score has a range of 0-25, with 0 representing a completely paralyzed upper limb and 25 representing a normally functioning upper limb.|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||units on a scale|Upper Limbs|Standard Deviation|Mean
2756395|NCT00833105|Primary|Grasp Release Test|The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.|Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training|"Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms."|||Objects moved|Arms|Standard Error|Mean
2756396|NCT00833092|Primary|Global Pittsburgh Sleep Quality Index|Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.|9 weeks|Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.|||score on a scale||Standard Error|Mean
2756397|NCT00833053|Secondary|Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28|The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
2756398|NCT00833053|Secondary|Dermatology Life Quality Index (DLQI) at Week 28|The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.|Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
2756399|NCT00833053|Secondary|Change From Baseline in Mean Participant Raw PASI Scores at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
2756400|NCT00833053|Secondary|Number of Participants With A PASI-100 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
2756401|NCT00833053|Secondary|Number of Participants With A PASI-90 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
2756402|NCT00833053|Secondary|Number of Participants With A PASI-50 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
2756404|NCT00833040|Primary|Time-weighted SPID30|time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.|30 minutes after dosing|Intent to treat population defined as all patients who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
2756405|NCT00833027|Secondary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 12|Includes all patients who received at least one dose of study medication and have a Week 12 measure.|||Percent||Standard Deviation|Mean
2756406|NCT00833027|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 24|Includes all patients who received at least one dose of study medication and have a Week 24 measure.|||Percent||Standard Deviation|Mean
2756407|NCT00832975|Secondary|Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure||24 months||||Patients|||Number
2756408|NCT00832975|Primary|Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)|Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec|24 months|157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it|||Episodes|||Number
2756409|NCT00832871|Other Pre-specified|Overall Survival|The time from patient entry into the protocol to death by any cause.|5 years||||Months||Standard Deviation|Median
2756410|NCT00832871|Secondary|Toxicity Associated With Adrenal Insufficiency|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts the following events of interest, which are related to possible adrenal insufficiency: nausea, vomiting, lethargy, dizziness, fatigue, anorexia, and skin rash. Any grade of these events that are self-reported by patients as well as events identified by physician assessment (e.g. physical exam) will be included.|Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest)|All patients received at least one dose of study medication and are included in this analysis.|||percentage of participants|||Number
2756411|NCT00832871|Primary|Duration of Response|The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years|Only one patient achieved stable disease. This patient's duration of response could therefore be reported. The other three patients progressed on treatment.|||days||Full Range|Median
2756412|NCT00832819|Secondary|To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.|Refer safety section for safety analysis|Throughout the study until 30 days after last dose|||||||
2756413|NCT00832819|Secondary|Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.||At various time points until Day 22 of Cycle 1|||||||
2756414|NCT00832819|Primary|Maximum Tolerated Dose (MTD)|Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.|7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1|DLTs were analyzed on the Safety Analysis Set; however subjects with 75% or less treatment compliance for E7080 in Cycle 1 or those who discontinued the study and had no confirmed data on tolerability up to Cycle 1 Day 22 were excluded from this analysis.|||mg BID|||Number
2756415|NCT00832819|Secondary|Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.||At Screening, on Day 22 of every even cycle, and at discontinuation|||||||
2756416|NCT00832780|Secondary|Clinical Benefit Rate (CBR)|CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).|2 years||||Participants|||Count of Participants
2756417|NCT00832780|Secondary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||Participants|||Count of Participants
2756418|NCT00832780|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|1 year||||Participants|||Count of Participants
2756419|NCT00832780|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.|2 years||||participants|||Number
2756420|NCT00832780|Primary|Response Rate (RR)|RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)|2 years||||Participants|||Count of Participants
2756422|NCT00832767|Secondary|Mental Quality of Life|"SF8 scale was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.~The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL."|Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)|The number includes participants who completed the SF8 questionnaire.|||units on a scale||Standard Deviation|Mean
2756423|NCT00832767|Secondary|Physical Quality of Life|"SF8 questionnaire was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.~The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL."|Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)|Number includes all participants who completed SF8 Quality of Life Questionnaire.|||units on a scale||Standard Deviation|Mean
2756424|NCT00832767|Secondary|Modified Hollander|Surgeons were asked to answer 6 questions regarding the appearance of their subjects' scars. Each patient's score was summed for a total score 0 to 6 with 0 being the best.|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes all participants where Modified Hollander Score was completed.|||units on a scale||Standard Deviation|Mean
2756425|NCT00832767|Secondary|Normalized Scar Scores|"Photo Series Questionnaire (PSQ). All subjects were asked to score their own scar (Question 1), then rate 2 standardized photos (one of 4PLC scars and one of a SILS™ scar) (Questions 2 and 3, respectively) and finally rate their own scar again after viewing the photos (Question 4). All scars were rated on a scale from 1 to 10 with 10 being the best.~Normalized scores were analyzed for the photo questionnaire. In order to calculate the normalized score, each patient's score of the 4PLC photo was subtracted from their score of their own scar before viewing the photos. the median values were then used to calculate statistical significance.~Normalized Scores of Own Scar are reported below:~Question 1 - Question 2 (Q1 - Q2) Question 4 - Question 2 (Q4 - Q2)~In order to calculate the normalized score for the subject's own scar, Q2 was used as baseline score since Q2 was the score for the conventional procedure 4PLC."|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes all participants who completed the Photo Series Questionnaire.|||units on a scale||Standard Deviation|Mean
2756426|NCT00832767|Secondary|Confidence Scale Change From Baseline|"The Confidence Scale consists of Questions 9 and 10 on the Body Image Questionnaire. One question is before procedure and another is after procedure. The Patients were asked to rate their overall confidence before (baseline) and after the procedure. The scores for before/after procedure range from 1 to 10 with 1 being not very confident and 10 being very confident. The score difference from the before/after treatment is compared between the two procedures (4PLC and SILS™)~Here, a positive score indicates that patient confidence has increased."|Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year|The number analyzed includes participants who completed questions 9 & 10 on the Body Image Questionnaire. Mean Change from Baseline (Pre-Op).|||units on a scale||Standard Deviation|Mean
2756427|NCT00832767|Secondary|Cosmetic Scale|The Cosmetic Scale consists of Questions 6-8 on the Body Image Questionnaire. Here, patients were asked to answer questions regarding the cosmesis of their own scar (SILS™) or scars (4PLC). The first 2 questions were answered on a scale from 1 to 7 and Question 8 from 1 to 10, both with 1 being the worst. Therefore, a total score of 3-24 was calculated for each patient with 3 being the worst.|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes participants who completed the Cosmetic Scale|||units on a scale||Standard Deviation|Mean
2756428|NCT00832767|Secondary|Body Image Scale|The Body Image Scale consists of Questions 1-5 on the Body Image Questionnaire. Here, subjects were asked to answer each question on a scale from 1 to 4 with 1 being the best. Therefore, a total score of 5-20 was calculated for each patient with 5 being the best.|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes participants who completed the Body Image Questionnaire.|||units on a scale||Standard Deviation|Mean
2756429|NCT00832767|Secondary|Average Pain Experienced in the Last 24 Hours at Various Time Frames|Pain evaluation as determined by a 10-point pain intensity numerical rating scale (PI-NRS) ranging from 0 (no pain) to 10 (worst possible pain).|Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)|Number includes patients who completed pain evaluation questionnaire.|||units on a scale||Standard Deviation|Mean
2756430|NCT00832767|Primary|Estimated Blood Loss|Blood loss from surgical procedure in cc.|Day 0||||cc||Standard Deviation|Mean
2756431|NCT00832767|Primary|Operative Time|Duration of surgical procedure in minutes.|Day 0|One site did not collect the operative time for a patient in the SILS group|||minutes||Standard Deviation|Mean
2756432|NCT00832767|Primary|Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC|Feasibility and safety as determined by intraoperative and postoperative adverse events.|One year||||Participants|||Number
2756433|NCT00832650|Secondary|Mean Proportion of Bowel Movements With Satisfaction Per Day|"The number of stools with satisfaction of Yes divided by the total number of stools passed on each notional day. Mean of 3 days."|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||mean proportion||Standard Deviation|Mean
2756434|NCT00832650|Secondary|Average Score of Ease of Passage During Defecation Per Day|Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||score on a scale||Standard Deviation|Mean
2756435|NCT00832650|Secondary|Mean Score of Stool Consistency Per Day|Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||score on a scale||Standard Deviation|Mean
2756453|NCT00832572|Secondary|Response to Thermal and Mechanical Stimuli|The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.||||||
2756439|NCT00832650|Secondary|Colonic Transit at 48 Hours|Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 14 (Day 12 48 hours post-meal)|ITT included all randomized subjects. Imputation by overall mean for missing data.|||counts||Standard Deviation|Mean
2756440|NCT00832650|Secondary|Proximal Colonic Emptying Time|Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12 to 14|ITT included all randomized subjects. Imputation by overall mean for missing data.|||hours||Standard Deviation|Mean
2756441|NCT00832650|Primary|Colonic Transit at 24 Hours|Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 13 (Day 12 24 hours post-meal)|Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data.|||counts||Standard Deviation|Mean
2756442|NCT00832637|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).|Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks||||participants|||Number
2756443|NCT00832637|Secondary|Median Survival Time (MST)|Survival is defined as the time from treatment initiation to death by any cause|2 years||||weeks||95% Confidence Interval|Median
2756444|NCT00832637|Secondary|Time to Tumor Progression (TTP)|The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||weeks||95% Confidence Interval|Median
2756445|NCT00832637|Secondary|Overall Response Rate|"Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks||||percentage of evaluable participants|||Number
2756446|NCT00832637|Primary|Tumor Control Rate|"Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks||||percentage of evaluable participants|||Number
2756447|NCT00832624|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18|Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.|Baseline and Week 18|The study was terminated early and no data were analyzed for this outcome.||||||
2756448|NCT00832598|Secondary|Explore if [18F]FACBC PET and [18F]FLT PET Imaging Can be Related to Molecular Markers (AKT, VEGFR, and Related Signaling/Biologic Changes by Immunohistochemistry and/or Analysis of Flash Frozen Tissue)||2 years|Data was not collected||||||
2756449|NCT00832598|Secondary|Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30).||2 years|Data was not collected||||||
2756450|NCT00832598|Primary|Determine & Comp Biodistribution, Clearance, & Dosimetry of [18F]FACBC & [18F]FLT Tissue/Organs w/i the Field of View of the Dynamic PET Imag Studies prior-to & During Anti-AKT &/or Anti-VEGF Directed Therapies Alone or in Combin With Radia for Glioma.||2 years|Data was not collected||||||
2756451|NCT00832585|Secondary|Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.|The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).|Week 1 to week 16||||Scores on a scale||Full Range|Median
2756452|NCT00832585|Primary|Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.|The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.|Week 1 to week 16|8 (4 female and 4 male) atopic patients, ranging in age from 24 to 54 yrs of age, were screened for the study. 5 patients were enrolled for 12 wks of treatment, but only 3 completed the study.|||Scores on a scale.||Full Range|Median
2756454|NCT00832572|Secondary|Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire|The participant quality of life assessed utilizing the SF-36v2 questionnaire|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.||||||
2756455|NCT00832572|Primary|Reduction in Neuropathic Pain|Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)|Baseline to Week 6|Study was stopped and no analysis was performed on the primary outcome measure.||||||
2756456|NCT00832520|Secondary|To Determine if the Quality of Life Improves After Starting Mirtazapine||8 weeks|There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.||||||
2756457|NCT00832520|Primary|Change in Weight||8 weeks|There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.||||||
2756458|NCT00832455|Other Pre-specified|Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)|"The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ).~PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described."|Weeks 4, 8, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Units on a Scale||Standard Deviation|Mean
2756459|NCT00832455|Other Pre-specified|Patient Global Satisfaction|At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|Week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Participants|||Number
2756460|NCT00832455|Other Pre-specified|Physician Global Satisfaction|At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.|week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Participants|||Number
2756461|NCT00832455|Secondary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Participants|||Number
2756462|NCT00832455|Primary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12.|||Participants|||Number
2756463|NCT00832416|Secondary|Percentage of Participants Who Dropped Out From Trial by Dropout Reason|Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.|||percentage of participants|||Number
2756464|NCT00832416|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
2756465|NCT00832416|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient's overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.|||participants|||Number
2756466|NCT00832416|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||mm||Standard Deviation|Mean
2756482|NCT00832130|Secondary|Discomfort Evaluation (Discomfort/Pain Score)|Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.|Treatment and 1 Day|Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.|||Scores on a scale|Participants|Standard Deviation|Mean
2756613|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure|change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
2756467|NCT00832416|Secondary|Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
2756468|NCT00832416|Secondary|Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
2756469|NCT00832416|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
2756470|NCT00832416|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.|||participants|||Number
2756471|NCT00832390|Primary|Change From Baseline in A1C at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 Weeks||||Percent Difference||95% Confidence Interval|Mean
2756472|NCT00832377|Other Pre-specified|Baseline IOP|"Baseline IOP was measured at ~9 AM of first day of treatment period.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline||||mmHg||Standard Deviation|Mean
2756473|NCT00832377|Secondary|Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks||||mmHg||Standard Deviation|Mean
2756474|NCT00832377|Secondary|Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks||||mmHg||Standard Deviation|Mean
2756475|NCT00832377|Primary|Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks||||mmHg||Standard Deviation|Mean
2756476|NCT00832338|Primary|Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)|"Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging.~If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists."|At time of definitive surgery|Staging information was not collected for two patients.|||Participants|||Count of Participants
2756477|NCT00832299|Secondary|Observation of Overall Pathologic Response Rate, Correlation of Pathologic Staging With Pre-op Ultrasound and Pelvic MRI Staging Observed Toxicities Patterns of Disease Relapse Disease-free Survival Overall Survival||5 years|Data not collected||||||
2756478|NCT00832299|Primary|Pathologic Complete Response||3-6 months|Study terminated prior to data collection of time frame||||||
2756479|NCT00832260|Secondary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).||12 months||||percentage of patients|||Number
2756480|NCT00832260|Primary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.||12 months||||percentage of patients|||Number
2756481|NCT00832130|Primary|Tear Break-up Time|Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.|||Seconds|Participants|Standard Deviation|Mean
2756483|NCT00832130|Secondary|(LogMAR) Best Spectacle Corrected Visual Acuity|Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.|Baseline, 2 Weeks and 4 Weeks|Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.|||LogMAR|Participants|Standard Deviation|Mean
2756484|NCT00832130|Secondary|Intraocular Pressure|Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.|Baseline through 4 Weeks|Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.|||mmHg|Participants|Standard Deviation|Mean
2756485|NCT00832130|Secondary|Ocular Surface Staining (Corneal Staining Sum Score)|Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.|||Scores on a scale|Participants|Standard Deviation|Mean
2756486|NCT00832130|Secondary|Dry Eye Symptoms (Total SPEED Score)|Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.|||Scores on a scale|Participants|Standard Deviation|Mean
2756487|NCT00832130|Primary|Incidence of Device-related Adverse Events|Number of eyes for which a device-related AE occurred|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population.|||Events|Participants||Number
2756488|NCT00832130|Primary|Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)|Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.|||Scores on a scale|Participants|Standard Deviation|Mean
2756489|NCT00832117|Secondary|Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 <LLN - 10.0 g/dL; Gr2 <10.0 - 8.0 g/dL; Gr3 <8.0 - 6.5 g/dL; Gr4 <6.5 g/dL. White Blood Cell Count (WBC) Gr1 <lower limit of normal (LLN) - 3000/mm^3; Gr2 <3000 - 2000/mm^3; Gr3 <2000 - 1000/mm^3; Gr4 <1000/mm^3. Absolute Neutrophil Count (ANC) Gr 1 <LLN - 1500/mm^3; Gr 2 <1500 - 1000/mm^3; Gr3 <1000 - 500/mm^3; Gr 4 <500/mm^3. Platelets Gr1 <LLN - 75,000/mm^3; Gr2 <75,000 - 50,000/mm^3; Gr3 <50,000 - 25,000/mm^3; Gr4 <25,000/mm^3. Normal ranges vary by local laboratory.|Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants|||participants|||Number
2756490|NCT00832117|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants|||participants|||Number
2756491|NCT00832117|Secondary|Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC)|The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment.|The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.||||||
2756492|NCT00832117|Secondary|Percentage of Participants With Response|Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.||||||
2756493|NCT00832117|Primary|Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.|Within the first 21 days of first cycle|All subjects who received at least 1 dose of either ixabepilone or carboplatin|||mg/m^2|||Number
2756614|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure|change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
2756494|NCT00832117|Secondary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of >=1 NTL (NonCR/NonPD) + no NWL; OR >=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|All treated participants|||participants|||Number
2756495|NCT00832117|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.|Within the first 21 days of first cycle|all treated participants|||participants|||Number
2756496|NCT00832091|Secondary|Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers|Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84|Up to 84 days|Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF)|||Participants|||Number
2756497|NCT00832091|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days|All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE|Up to 84 days|Analysis per protocol, ITT, using LOCF|||SAEs and AEs|||Number
2756498|NCT00832078|Secondary|Haematuria||After each catheterisation|||||||
2756499|NCT00832078|Secondary|Preference||At study termination|||||||
2756500|NCT00832078|Secondary|Handling||After each catheterisation|||||||
2756501|NCT00832078|Primary|Discomfort|Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)|After each catheterisation|The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM)|||units on a scale||Standard Deviation|Mean
2756502|NCT00832000|Secondary|Short Form 36 - Mental Composite Score|The SF-36 is a standard quality of life instrument. The mental composite score represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|The end of period 1 (week 4) and period 2 (week 9)|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756503|NCT00832000|Secondary|Short Form 36 - Physical Composite Score|The SF-36 is a standard quality of life instrument. The physical composite score represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|Particiapnts who experienced weakness on mexiletine in either period 1 or period 2.|All participants with SF-36 physical composite values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756504|NCT00832000|Secondary|Individualized Neuromuscular Quality of Life Scale - Summary Score|Quality of life scale for patinets with neuromuscular disorders. The INQoL summary score is a weighted average made up of 5 subdomains (activities, social relationships, independence, emotions, and body image) which document the impact of a disease on a patients' quality of life. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life. A higher score indicates more detrimental impact.|The end of period 1 (week 4) and period 2 (week 9)|All participants with INQoL summary score values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756505|NCT00832000|Secondary|Compound Motor Action Potentials After Long Exercise Test|Compound muscle action potential (CMAP) after long periods of exercise as a percentage of baseline.|The end of period 1 (week 4) and period 2 (week 9)|All participants with long exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
2756506|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Tibialis Anterior|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RTA values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756507|NCT00832000|Secondary|Clinical Eye Closure Myotonia Evaluation (Seconds)|Time to open the eyes after forced eye closure as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical eye closure myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.|||Seconds||95% Confidence Interval|Mean
2756508|NCT00832000|Secondary|Clinical Hand Grip Myotonia Evaluation (Seconds)|The time to open the fist after a forced handgrip as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.|||Seconds||95% Confidence Interval|Mean
2756509|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Abductor Digiti Minimi|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RADM values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756510|NCT00832000|Secondary|Compound Motor Action Potentials After Short Exercise Test|The maximal post-exercise compound muscle action potential (CMAP) after short periods of exercise as a percent of the baseline measurement.|The end of period 1 (week 4) and period 2 (week 9)|All participants with short exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
2756511|NCT00832000|Secondary|Quantitative Measure of Hand Grip Myotonia (Seconds)|Maximum voluntary contractions following forced right hand grip were recorded and the time to relax from 90% to 5% of average maximal force was determined using automated analysis software.|The end of period 1 (week 4) and period 2 (week 9)|All participants with quantitative handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean using log (t+0.1) 'normalizing' transformation. Confidence intervals are bootstrap confidence intervals.|||seconds||95% Confidence Interval|Mean
2756512|NCT00832000|Secondary|Patient Reported Tiredness on the IVR|Tiredness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of tiredness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|49 partipants who experienced tiredness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756513|NCT00832000|Secondary|Patient Reported Weakness on the IVR|Weakness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of weakness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|44 partipants who experienced weakness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756514|NCT00832000|Secondary|Patient Reported Pain on the IVR|Pain measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of pain for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeeks 3-4 of each period|48 partipants who experienced pain in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756515|NCT00832000|Primary|Patient-reported Stiffness on the IVR|Stiffness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of stiffness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
2756516|NCT00831987|Primary|Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||Day 21 post-vaccination||||Percentage of Participants|||Number
2756517|NCT00831987|Primary|Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||21 Days post-vaccination||||Percentage of Participants|||Number
2756518|NCT00831987|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine|GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.|Day 0 and Day 21 Post-Vaccination|Geometric Mean Titers were assessed in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2756519|NCT00831987|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination|"Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.~Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia"|0 to 3 days post-vaccination||||Percentage of Participants|||Number
2756520|NCT00831844|Primary|Disease Response|Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).|First six treatment cycles - 24 weeks|Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).|||patient|||Number
2756615|NCT00831129|Secondary|Change in Office Diastolic Blood Pressure|change in office diastolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
2756616|NCT00831129|Secondary|Change in Office Systolic Blood Pressure|change in office systolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
2756521|NCT00831792|Primary|The Number of Participants With Improvement, Disease Progression or Stable Disease|Three consecutive PSA elevations above nadir or baseline are required for progression. Each increment in PSA should be a minimum of 1 ng/ml and at least 2 weeks apart or will not count. The time of PSA progression will be taken as the time of the first of these PSA elevations that represents an increment by at least 25% above the nadir or baseline. Given that increments in PSA do not always represent treatment failure, particularly when novel agents with uncertain effects on PSA levels are being evaluated, clinical and radiological correlation is recommended at the discretion of the treating physician. In patients with PSA progression alone without clinical or radiological evidence of disease progression, continued therapy on study is at the discretion of the treating physician in consultation with the principal investigator.|From the time of enrollment until 30 days beyond the date of the last study drug administration|Patients completed at least 1 cycle of therapy|||Participants|||Count of Participants
2756522|NCT00831779|Secondary|Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)|||mU/L*min||Standard Error|Mean
2756523|NCT00831779|Primary|Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)|||% Change of Baseline Insulin Sensitivity||Standard Error|Mean
2756524|NCT00831766|Other Pre-specified|Median Relapse-Free Survival (RFS)|Relapse-Free Survival (RFS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be analyzed similarly. Descriptive analysis was planned for this measure.|24 Months|||||||
2756525|NCT00831766|Other Pre-specified|Rate of Cytogenetic Remission Following Induction Therapy|Rate of cytogenetic remission following induction therapy. Descriptive analysis was planned for this measure.|24 Months|||||||
2756526|NCT00831766|Secondary|Median Overall Survival (OS)|Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.|Up to 24 Months|All participants treated at MTD|||months||95% Confidence Interval|Median
2756527|NCT00831766|Secondary|Median Progression-Free Survival (PFS)|Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.|24 months|All participants treated at MTD.|||months||95% Confidence Interval|Median
2756528|NCT00831766|Secondary|Rate of Lenalidomide Related Toxicity During Maintenance Therapy|Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3. Adverse Events: Possibly Related; Probably Related, or Definitely Related to study treatment. Events are categorized as Grade 1 or 2, or as Grade 3 or 4.|24 months|All Maintenance Phase participants.|||Participants|||Count of Participants
2756529|NCT00831766|Primary|Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)|Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).|24 months|All participants treated at MTD|||percentage of participants|||Number
2756530|NCT00831766|Primary|Phase I: Recommended Phase II Dose|For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.|18 months|Phase I participants.|||mg/day|||Number
2756531|NCT00831753|Secondary|Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable."|Day 0 up to Day 7 after each injection|Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
2756532|NCT00831753|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.|Day 150 (1 month after dose 3)|Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2756617|NCT00831129|Secondary|Change in Malondialdehyde|change in Malondialdehyde between baseline and 6 month|Baseline and 6 months||||nM||Standard Deviation|Mean
2756533|NCT00831753|Primary|Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as:~Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL.~Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL."|Day 150 (1 month after dose 3)|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2756534|NCT00831753|Primary|Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™|Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 150 (1 month after dose 3)|Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2756535|NCT00831701|Secondary|Number of Participants Requiring Active Treatment|The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.|21 days||||participants|||Number
2756536|NCT00831701|Secondary|Maximum Daily Pain Score|All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).|Until stone expulsion or up to 21 days||||Units on a scale||Full Range|Median
2756537|NCT00831701|Secondary|Required Analgesics|Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day|Until stone expulsion or up to 21 days||||pills per day||Inter-Quartile Range|Median
2756538|NCT00831701|Secondary|Time to Stone Passage|The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.|21 days||||days||Inter-Quartile Range|Median
2756539|NCT00831701|Primary|Number of Participants With Stone Expulsion|The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).|21 days||||Participants|||Number
2756540|NCT00831675|Other Pre-specified|Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)|Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.|Day 14 post-vaccination|Seroconversion were evaluated in the per-protocol population.|||Percentage of Participants|||Number
2756541|NCT00831675|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.|14 days post-vaccination|Seroprotection were evaluated in the per-protocol population|||Percentage of Participants|||Number
2756542|NCT00831675|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation||14 days post-vaccination|GMTs were evaluated in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2756543|NCT00831675|Primary|Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation|"Solicited local reactions: Erythema, bruising, induration, pain at injection site.~Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection."|Days 0-3 Post-dose|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population|||Participants|||Number
2756544|NCT00831493|Primary|Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation|MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).|Toxicity assessment at 6 weeks following chemoradiation (6 weeks)|Analysis per protocol; Of the three participants enrolled only two were eligible for MTD calculation.|||mg|||Number
2756545|NCT00831480|Primary|Disease Progression Diagnosed by Biopsy|Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.|up to one year||||participants|||Number
2756551|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756546|NCT00831441|Secondary|Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants|Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
2756547|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants|ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
2756548|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants|ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
2756549|NCT00831441|Primary|Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants|TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
2756550|NCT00831441|Secondary|Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|"Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.~CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination)."|Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756552|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756553|NCT00831441|Secondary|Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants|Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination.|Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756554|NCT00831441|Secondary|Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants|MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice.|Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756555|NCT00831441|Secondary|Event Rate of Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756556|NCT00831441|Secondary|Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants|Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756557|NCT00831441|Primary|Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
2756558|NCT00831428|Secondary|Mini Nasal Lavage||This test will be performed prior to entering the pool, and on exiting the pool|||||||
2756559|NCT00831428|Secondary|Skin Prick Test||This test will be performed once on a district and once on a national squad training day|||||||
2756560|NCT00831428|Secondary|Nasal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool|||||||
2756561|NCT00831428|Primary|Tidal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool|Data from all participants was analysed|||ppb||95% Confidence Interval|Geometric Mean
2756562|NCT00831428|Secondary|Sport-based Challenge||This test will be performed once on a district and once on a national squad training day|||||||
2756563|NCT00831428|Secondary|Mannitol Challenge||This test will be performed once on a district and once on a national squad training day|||||||
2756605|NCT00831129|Secondary|Change in Adiponectin|change in Adiponectin between baseline and 6 month|Baseline and 6 months||||μg/ml||Standard Deviation|Mean
2756606|NCT00831129|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance|change in homeostatic model assessment for insulin resistance between baseline and 6 month|Baseline and 6 months||||HOMA units||Standard Deviation|Mean
2756564|NCT00831415|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.|Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment|Safety population: all enrolled participants who received at least 1 dose of study treatment in this extension study.|||percentage of participants|||Number
2756565|NCT00831415|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score|CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.|Baseline (Extension Study) up to Day 308 or FOT Evaluation|ITT; LOCF and Observed cases (non-missing data); (n)=number of participants with analyzable data at observation.|||scores on a scale||95% Confidence Interval|Mean
2756566|NCT00831415|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 308 or FOT Evaluation|ITT; LOCF. Improvement measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).|||participants|||Number
2756567|NCT00831415|Primary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score|"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last on-therapy evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit."|Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation|Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.|||scores on a scale||95% Confidence Interval|Mean
2756568|NCT00831389|Post-Hoc|Overall Incidence of Hypoglycemia|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||hypoglycemic events||Inter-Quartile Range|Median
2756569|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||percentage of time||Inter-Quartile Range|Median
2756570|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||percentage of time||Inter-Quartile Range|Median
2756571|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.|For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||percentage of time||Inter-Quartile Range|Median
2756572|NCT00831389|Secondary|Overnight Nadir Plasma Glucose (PG)|For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.|Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
2756573|NCT00831389|Secondary|Nadir Plasma Glucose (PG) Immediately Following Exercise|The PG nadir observed following the start of exercise|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
2756574|NCT00831389|Secondary|Peak Post-prandial Plasma Glucose (PG)|For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.|Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
2756575|NCT00831389|Primary|Incidence of Nocturnal Hypoglycemia Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis|||hypoglycemic events||Inter-Quartile Range|Median
2756607|NCT00831129|Secondary|Change in Insulin|change in Insulin between baseline and 6 month|Baseline and 6 months||||IU/ml||Standard Deviation|Mean
2756608|NCT00831129|Secondary|Change in Fasting Blood Glucose|change in fasting blood glucose between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
2756576|NCT00831389|Primary|Incidence of Hypoglycemia Immediately Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.|All subjects were used for final analysis|||hypoglycemic events||Inter-Quartile Range|Median
2756577|NCT00831389|Primary|Plasma Glucose (PG) Response to Exercise|PG at start of exercise minus the subsequent PG nadir|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
2756578|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.~Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.|||Participants|||Number
2756579|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intend-to-treat) population.|||Participants|||Number
2756580|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.|||Participants|||Number
2756581|NCT00831311|Primary|Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2756582|NCT00831311|Primary|Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2756583|NCT00831311|Primary|Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.~Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination."|Day 150 (1 month post-vaccination 3)|Seroprotection to the vaccine antigens was assessed in the per-protocol population.|||Percentage of Participants|||Number
2756584|NCT00831311|Primary|Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.|1 month post last vaccination|Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.|||Percentage of Participants|||Number
2756585|NCT00831272|Primary|Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial.||12 weeks|Repeated weekly measures of drinking outcomes were compared using generalized estimating equation models (GEE). The explanatory variables of primary interest comprised binary indicators for intervention group, genotype, and their interaction, a linear trend for time, and terms for interactions involving time and the group and genotype factors.|||percentage of heavy drinking days||Standard Deviation|Mean
2756586|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.|Baseline to 12 weeks of treatment|FAS.|||participants|||Number
2756587|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).|||participants|||Number
2756588|NCT00831233|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.|||score on scale||Standard Deviation|Mean
2756589|NCT00831233|Secondary|Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.|||percentage||Full Range|Median
2756590|NCT00831233|Secondary|Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.|||participants|||Number
2756591|NCT00831233|Secondary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12|TRUS is a method of measuring the size of the prostate.|After 12 weeks treatment compared to Baseline|FAS, Observed Cases (OC).|||mL||Standard Deviation|Mean
2756592|NCT00831233|Secondary|Change From Baseline in Residual Volume (Vresidual) at Each Visit|Uroflowmetry was used to quantify the residual volume (Vresidual; mL)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.|||mL||Standard Deviation|Mean
2756593|NCT00831233|Secondary|Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit|Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.|||mL/sec||Standard Deviation|Mean
2756594|NCT00831233|Secondary|Change From Baseline in Total IPSS at Weeks 4 and 8|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4 and 8 weeks compared to Baseline|FAS, LOCF.|||score on scale||Standard Deviation|Mean
2756595|NCT00831233|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).|||score on scale||Standard Deviation|Mean
2756596|NCT00831181|Secondary|Number of Participants With Comparison of Preoperative Stage With Post-treatment Pathologic Stage|Thin-section high resolution pelvic MRI was used to image the tumor prior to chemoradiation and repeated prior to surgery, and then compared to post-treatment pathological stage.|Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.|Out of the 27 patients enrolled, a total 23 underwent TME. These 23 patients were included for comparison of preoperative stage and post-treatment pathologic stage.|||patient|||Number
2756597|NCT00831181|Secondary|Patterns of Disease Failure, Including Local Recurrence and Distant Metastasis Assessed by CT Scan||median follow-up 22 months|Out of the 27 patients enrolled, a total 23 underwent TME and were assessed for patterns of disease failure.|||patients|||Number
2756598|NCT00831181|Secondary|Overall Survival||median follow-up 22 months|Patients who completed treatment|||participants|||Number
2756599|NCT00831181|Secondary|Disease-free Survival||median 22 months follow-up|Out of the 27 patients enrolled, a total 23 underwent TME and were assessed for disease-free survival.|||participants|||Number
2756600|NCT00831181|Secondary|Local Regional Control|subjects were followed for median of 22 months post-surgery|median follow-up 22 months post-TME|Out of the 27 patients enrolled, a total 23 underwent TME and were assessed for local regional control.|||patient|||Number
2756601|NCT00831181|Secondary|Complete Resectability Rates|Complete resectability rates assessed by circumferential margin.|Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.|Out of the 27 patients enrolled, a total 23 underwent TME.|||patient|||Number
2756602|NCT00831181|Secondary|Treatment Toxicity|Toxicity was assessed weekly during neoadjuvant chemotherapy and radiation therapy, bi-weekly during adjuvant FOLFOX therapy.|Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).|According to the citation J Clin Oncol 28,2010 (suppl; abstract e14128): acute grade 3-4 toxicities occurred in 16 patients, mainly hypersensitivity reactions and OXA associated peripheral neuropathy.|||patients|||Number
2756603|NCT00831181|Primary|Pathologic Response and Complete Response|"Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation.~The unit of measure is the tumor response rate to preoperative chemoradiation.~Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer.~Tumor regression grade (TRG) will be quantitated into five grades:~TRG 1 (complete regression) -absence of residual cancer and fibrosis extending from the site of original tumor through the layers of the rectal wall.~TRG 2 characterized by the presence of rare residual cancer cells scattered through the fibrosis.~TRG 3 characterized by an increase in the number of residual cancer cells, but fibrosis still predominant.~TRG 4 -residual cancer outgrowing fibrosis. TRG 5 characterized by absence of regressive changes."|Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months|Number of subjects undergoing TME|||Participants|||Number
2756604|NCT00831129|Secondary|Change in Body Mass Index|change in body mass index between baseline and 6 month|Baseline and 6 months||||kg/m2||Standard Deviation|Mean
2756620|NCT00830960|Secondary|Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
2756621|NCT00830960|Secondary|Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary|"The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.~Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).~A higher value for change in PRU indicates a greater level of platelet inhibition."|Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase|"Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization.~Participants classified as EM or RM. Invalid measurements of PRU were excluded."|||Change in PRU||Standard Deviation|Mean
2756622|NCT00830960|Secondary|Inpatient Healthcare Resource Utilization|Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.|Initial hospitalization, 30 days, 90 days|As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.|||participants|||Number
2756623|NCT00830960|Secondary|Incidence of CABG-related TIMI Major or Minor Bleeding.||Randomization through end of study (90 days)|"Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug~In 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event"|||participants|||Number
2756624|NCT00830960|Secondary|Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding|"Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.~Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.~Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but <5 gm/dL from baseline.~Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed."|Randomization through end of study (90 days)|"Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug~Two (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table."|||participants|||Number
2756625|NCT00830960|Secondary|Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort|Risk was defined as the number of participants with events of all-cause death.|Randomization through end of study (90 days)|Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug|||Participants|||Number
2756626|NCT00830960|Secondary|Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition|"Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
2756627|NCT00830960|Secondary|Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition|"Risk was defined as the number of participants with events of definite or probable stent thrombosis.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
2756628|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
2756629|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization|"Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.~Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||Participants|||Number
2756630|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||Participants|||Number
2756631|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.~CV death: death caused by CV event or not clearly attributable to non-CV causes.~Nonfatal MI: per adapted American College of Cardiology definition.~Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
2756632|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort|"Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were <75 years).~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel."|At 30 days during MD therapy|"Per protocol set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event"|||PRU||Standard Deviation|Mean
2756633|NCT00830960|Secondary|Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort|"Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting >24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure"|Randomization through end of study (90 days)|"Full analysis set (FAS)~FAS: all randomized subjects who received at least 1 dose of study drug"|||Participants|||Number
2756634|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 days and at 90 days during MD therapy|"Per Protocol Set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event"|||Percent inhibition|||Number
2756635|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 minutes, 2 hours, and 4 hours following LD administration|Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event|||Percent inhibition|||Number
2756636|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|"Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.~Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel."|At 30 Days and 90 days during MD therapy|Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event|||PRU||Standard Deviation|Mean
2756637|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.|"Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.~Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel."|At 30 minutes, 2 hours, and 4 hours following LD administration|"Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event"|||PRU||Standard Deviation|Mean
2756649|NCT00830869|Secondary|Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib|AUC (0-72) is a measure of the area under the plasma concentration-time curve from time 0 to 72 hours post-dose for ixazomib.|Part 1: Cycle 1 Days 1 and 11: pre-dose and at multiple time points (up to 72 hours) post-dose|PK analysis population where data at specified time points was available,defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions, did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2756638|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)|"ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.~Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase."|At 4 hours following LD administration|"Per Protocol Set (PPS) LD population~PPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event"|||PRU||Standard Deviation|Mean
2756639|NCT00830947|Primary|The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.||Time to Space Closure, an average of 22 weeks||||mm/week||Standard Deviation|Mean
2756640|NCT00830869|Secondary|Expression of Biomarker (ATF-3) in Tumor Tissue||Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose|This outcome measure was not analyzed due to lack of tumor activity data.||||||
2756641|NCT00830869|Secondary|20S Proteasome Activity of Ixazomib in the Tumor Tissue||Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose|This outcome measure was not analyzed due to lack of tumor activity data.||||||
2756642|NCT00830869|Secondary|Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC|The average data of Days 1 and 4 of Cycle 1 was reported.|Cycle 1 Days 1 and 4: Predose and (from 4-20 hours) post-dose|The tumor PK analysis set where Day 1 and 4 assessment were available. The tumor PK and PD analysis population includes all participants who provided a baseline tumor biopsy sample and 1 post-baseline tumor biopsy sample on Day 1 or Day 4.|||nanogram per gram (ng/g)||Standard Deviation|Mean
2756643|NCT00830869|Secondary|Number of Participants With Best Overall Response|Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above normal limits. Progressive disease: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Day 18 up to Day 21 of each cycle (Part 1: up to Cycle 10; Part 2: up to Cycle 12)|The response-evaluable population included all participants who received at least 1 cycle of ixazomib treatment, had measurable disease at baseline, and had at least 1 postbaseline response assessment.|||participants|||Number
2756644|NCT00830869|Secondary|Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib|TEmax is the time to reach the Emax, equal to time (hours) to Emax.|Part 1: Cycle 1 Days 1 and 11 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose|PD analysis population where baseline/post-baseline assessments was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive any excluded concomitant medications in Cycle 1,had sufficient effect-time data to permit estimation of PD parameters.|||hour||Full Range|Median
2756645|NCT00830869|Secondary|Part 1: E Max: Maximum Observed Effect for Ixazomib|E max is the maximum inhibition of 20S proteasome activity in whole blood.|Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose|PD analysis population where baseline/post-baseline assessments was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive any excluded concomitant medications in Cycle 1,had sufficient effect-time data to permit estimation of PD parameters.|||percentage of inhibition||Standard Deviation|Mean
2756646|NCT00830869|Secondary|Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib|T1/2 is the time required for half of the drug to be eliminated from the plasma.|Part 1: Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose|PK analysis population defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.|||hours||Standard Deviation|Geometric Mean
2756647|NCT00830869|Secondary|Part 1: Rac: Accumulation Ratio for Ixazomib|Rac was estimated as the ratio of AUC (0-72) on Day 11 and AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time 0 to 72 hours post-dose.|Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|PK analysis population defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.|||ratio||Standard Deviation|Geometric Mean
2756648|NCT00830869|Secondary|Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration|C0 is the plasma drug concentration at time zero following bolus intravenous injection.|Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose|PK analysis population where data at specified time points was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.|||nanogram per mililiter (ng/mL)||Standard Deviation|Geometric Mean
2756830|NCT00829764|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756650|NCT00830869|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital sign measurements included diastolic and systolic blood pressure, heart rate, weight and oral temperature.|Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)|The safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2756651|NCT00830869|Primary|Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities||Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)|The safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2756652|NCT00830869|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)||Part 1: Cycle 1 Day 1 up to Cycle 10 Day 41; Part 2: Cycle 1 Day 1 up to Cycle 12 Day 41|The safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2756653|NCT00830869|Primary|Part 1: Number of Participants With Dose Limiting Toxicity (DLT)|Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count<500 cells/cubic meter[cells/mm^3])for>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets <25,000 cells/mm3)for>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count<10,000 cells/mm3; GR 3 peripheral neuropathy;>=GR 3 nausea/emesis in absence of optimal antiemetic therapy; >=GR 3 diarrhoea in absence of optimal supportive therapy;GR 3 QTc prolongation noted on average of 3 electrocardiograms (ECGs);>=GR 3 nonhematological toxicity except GR 3 arthralgia/myalgia or GR 3 fatigue for<1 week; Delay in initiation of subsequent therapy cycle by>7 days due to treatment-related toxicity Other>=GR 2 nonhematological toxicity that opinion of investigator, requires discontinuation of therapy with Ixazomib.|Part 1: Cycle 1 Day 1 up to Cycle 1 Day 21|The DLT population included all participants who received all Cycle 1 doses of ixazomib and who had completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.|||participants|||Number
2756654|NCT00830804|Secondary|Plasma Trough Concentration of Darunavir|Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.|||ng/ml||Inter-Quartile Range|Median
2756655|NCT00830804|Secondary|Plasma Trough Concentration of Raltegravir|Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.|||ng/ml||Inter-Quartile Range|Median
2756656|NCT00830804|Secondary|Change in CD4 Count at Week 48|Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.|From start of study treatment through week 48|Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.|||cells/mm3||Inter-Quartile Range|Median
2756657|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
2756658|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
2756659|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
2756660|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
2756661|NCT00830804|Secondary|Number of Participants With Perfect Overall Adherence by Self Report|"At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence."|From one week after starting study treatment to week 52|All participants who started study treatment were included in the analysis.|||participants|||Number
2756662|NCT00830804|Secondary|Number of Participants With Protease Drug Resistance at Virologic Failure|Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.|||participants|||Number
2756663|NCT00830804|Secondary|Number of Participants With Integrase Drug Resistance at Virologic Failure|Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.|||participants|||Number
2756664|NCT00830804|Secondary|Number of Participants With Pretreatment Drug Resistance|Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.|At screening|All participants who started study treatment were included in the analysis.|||participants|||Number
2756665|NCT00830804|Secondary|Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.|From start of study treatment to week 52|All participants who started study treatment were included in the analysis.|||proportion of participants||95% Confidence Interval|Number
2756666|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48|Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.|From start of study treatment to week 48|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.|||proportion of participants||95% Confidence Interval|Number
2756667|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24|Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.|From start of study treatment to week 24|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.|||proportion of participants||95% Confidence Interval|Number
2756668|NCT00830804|Secondary|Change in Plasma HIV-1 RNA From Baseline to Week 1|Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.|Baseline and week 1|Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.|||log10 copies/ml||Inter-Quartile Range|Median
2756669|NCT00830804|Secondary|Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24|The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to Week 24|All participants who started study treatment were included in the analysis.|||Proportion of participants||95% Confidence Interval|Number
2756670|NCT00830804|Primary|Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24|Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to week 24|All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.|||Proportion of participants||95% Confidence Interval|Number
2756671|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756672|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756673|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756674|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756675|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756676|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756677|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756678|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756679|NCT00830791|Secondary|Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
2756680|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
2756681|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||Standard Deviation|Geometric Mean
2756682|NCT00830791|Secondary|Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||Standard Deviation|Geometric Mean
2756683|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
2756684|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||95% Confidence Interval|Geometric Mean
2756685|NCT00830791|Secondary|Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||95% Confidence Interval|Geometric Mean
2756686|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
2756687|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||nM||95% Confidence Interval|Geometric Mean
2756688|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
2756689|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||nM per Hour||95% Confidence Interval|Geometric Mean
2756690|NCT00830791|Primary|Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.|72 Hours Post-Dose||||nM per Hour||95% Confidence Interval|Geometric Mean
2756691|NCT00830791|Secondary|Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose||||nM||95% Confidence Interval|Geometric Mean
2756692|NCT00830765|Primary|Weeks Gestation at Birth Among Patients Receiving the Active Drug.|Weeks gestation at birth, the interval to delivery, or neonatal morbitity.|Through delivery, until discharge up to 40 weeks gestation|Intention to treat analysis in both groups|||weeks||Standard Deviation|Mean
2756693|NCT00830596|Primary|Response to Sudden Load Response Times|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)|Baseline and 2 weeks||||ms||95% Confidence Interval|Mean
2756694|NCT00830596|Primary|Response to Sudden Load, Peak Muscle Response Per Side|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)|Baseline and 2 weeks||||% muscle response||95% Confidence Interval|Mean
2756695|NCT00830596|Primary|Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure|Baseline and 2 weeks||||mm||95% Confidence Interval|Mean
2756696|NCT00830596|Primary|Postural Sway Speed|"Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:~Sway Speed=overall center of pressure traveling distance divided by time."|Baseline and 2 weeks||||mm/s||95% Confidence Interval|Mean
2756697|NCT00830596|Primary|Postural Sway|"Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:~Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction."|Baseline and 2 weeks||||mm||95% Confidence Interval|Mean
2756698|NCT00830518|Secondary|Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events|Abnormal Laboratory Values for Chemistry or Hematology tests that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. A treatment--emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 18.9 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
2756699|NCT00830518|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events|Vital signs measurements (blood pressure, heart rate, and oral temperature) were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 18.9 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
2756795|NCT00830115|Primary|Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)|Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 869~Day 1 = 868~Day 2 = 867~Day 3 = 864~Day 4 = 863~Day 5 = 859~Day 6 = 862"|||Units on a scale||Standard Deviation|Mean
2756700|NCT00830518|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.|First dose of study drug to 30 days after last dose (Up to 18.9 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
2756701|NCT00830518|Secondary|Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment|Best overall HI response is defined as percentage of participants with response as assessed by Investigator based on IWG criteria: 1)Erythroid response (pretreatment,<11 g/dL): hemoglobin (Hgb) increase by ≥1.5 g/dL, relevant reduction of units of red blood cell (RBC) transfusions by absolute number of at least 4 RBC transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks. Only RBC transfusions given for Hgb of ≤9.0 g/dL pretreatment will count in RBC transfusion response evaluation. 2)Platelet response (pretreatment,<100x10^9/L):Absolute increase of ≥30x10^9/L for participants starting->20x10^9/L platelets, increase <20x10^9/L to >20x10^9/L by at least 100%. 3)Neutrophil response (pretreatment,<1.0x10^9/L):At least 100% increase and an absolute increase >0.5x10^9/L. 4)Progression or relapse after HI:At least 1 of following: 50% decrement from maximum response levels in granulocytes or platelets, or reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Safety population was defined as all participants who received any amount of alisertib.|||percentage of participants|||Number
2756702|NCT00830518|Secondary|Duration of Response (DOR)|Duration of response is defined as the time from the date of first documentation of a response to the date of first documented PD.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Response-­Evaluable Population included all participants who had measurable disease, received at least 1 dose of alisertib, and had at least 1 post baseline response assessment. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.|||days||95% Confidence Interval|Median
2756703|NCT00830518|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first study drug administration to the date of first documented progressive disease (PD) or death.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.|||days||95% Confidence Interval|Median
2756704|NCT00830518|Primary|Best Overall Response Rate (ORR) Based on Investigator's Assessment|Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils >1x10^9/L, platelets >100x10^9/L, bone marrow blasts(BMB) <5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB <5%, transfusion independent, no EMD; PR=neutrophils >1x10^9/L, platelets >100x10^9/L, BMB >50% decrease and 5% to 25%, blasts <5% with Auer rods; PRi=BMB >50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10^9/L, neutrophils ≥1.0x10^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still >5%; PRi=BMB decreased by ≥50% over pretreatment but still >5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. In 2 participants disease transformed from MDS to AML. One participant is considered AML and one participant is considered MDS in the calculation, based on the timing of their transformation.|||participants|||Number
2756705|NCT00830440|Secondary|Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12||Baseline to Week 12 of treatment|Type 2 Diabetes Subjects|||Participants|||Count of Participants
2756706|NCT00830440|Secondary|% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks|The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.|12 weeks||||% participants|||Number
2756707|NCT00830440|Primary|Total Weight Change From Baseline at 12 Weeks in kg||12 weeks|26 subjects received the device. 2 subjects had the device removed before 12 weeks.|||kg||Standard Deviation|Mean
2756708|NCT00830388|Secondary|To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.|Adverse events were used to assess safety.|4 weeks||||events|||Number
2756709|NCT00830388|Primary|The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor|Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.|4 weeks||||participants|||Number
2756710|NCT00830375|Primary|Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)|The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms|from study start to study end (8-weeks) and is Investigator rated|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
2756711|NCT00830362|Primary|Single Item Craving Test Session Difference Scores|Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.|Both days of cue exposure||||units on a scale||Standard Error|Mean
2756712|NCT00830336|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.|||ng*h/mL||Standard Deviation|Mean
2756713|NCT00830336|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.|||ng*h/mL||Standard Deviation|Mean
2756714|NCT00830336|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.|||ng/mL||Standard Deviation|Mean
2756715|NCT00830310|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756716|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)|"Treatment nonadherence is measured as a percentage of medications not taken within the past week at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||percentage of medications not taken||Standard Error|Mean
2756717|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756718|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756719|NCT00830310|Secondary|Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756720|NCT00830310|Secondary|Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)|The minimum score is 0 and the maximum score is 10. A higher score implies a better attitude.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756721|NCT00830310|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756722|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2756723|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)|"Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||percentage of medication not taken||Standard Error|Mean
2756724|NCT00830284|Secondary|Number of Participants With Ventilator Induced Lung Injury|Incidences of lack of airleak - defined as pneumothorax requiring intervention cardiac compromise - requiring change in pressor support respiratory acidosis - pH < 7.20|4 hours||||Participants|||Count of Participants
2756725|NCT00830284|Primary|Oxygenation|PaO2 + PaCO2 of 400 or higher.|2 hours||||Participants|||Count of Participants
2756726|NCT00830258|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756727|NCT00830258|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756728|NCT00830258|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756729|NCT00830232|Secondary|Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI||within 24 hours after carotid artery stenting|||||||
2756730|NCT00830232|Secondary|Composite of Any Stroke, Myocardial Infarction or Death||within 30 days after the carotid stenting procedure|||||||
2756731|NCT00830232|Primary|Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.|Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.|First 24 hours after implantation of carotid stent||||Micro-emboli||Inter-Quartile Range|Median
2756732|NCT00830219|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756733|NCT00830219|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756734|NCT00830219|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756735|NCT00830206|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.|||ng*h/mL||Standard Deviation|Mean
2756736|NCT00830206|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.|||ng*h/mL||Standard Deviation|Mean
2756737|NCT00830206|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.|||ng/mL||Standard Deviation|Mean
2756738|NCT00830167|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756739|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756740|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756741|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756742|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756743|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756744|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756745|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756746|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756747|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756748|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756749|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756750|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756751|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756752|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756814|NCT00829933|Secondary|Pharmacodynamic Parameters (PT, PT-INR, and APTT)|PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time|12 weeks|||||||
2756753|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756754|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756755|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756756|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756757|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756758|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756759|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756760|NCT00830167|Secondary|Change From Baseline in Sleep Quality Score at Endpoint|Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756761|NCT00830167|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Participants|||Number
2756769|NCT00830167|Secondary|"Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC)"|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.|||Percentage of participants|||Number
2756762|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756763|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756764|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756765|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756766|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756767|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756768|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756794|NCT00830115|Primary|Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 846~Day 1 = 841~Day 2 = 828~Day 3 = 817~Day 4 = 800~Day 5 = 791~Day 6 = 790"|||Units on a scale||Standard Deviation|Mean
2756770|NCT00830167|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
2756771|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756772|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756773|NCT00830128|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Paticipants|||Number
2756774|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756775|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756776|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||hours||Standard Deviation|Mean
2756777|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756778|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756815|NCT00829933|Secondary|Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment||12 weeks|||||||
2756779|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756780|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2756781|NCT00830128|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|"The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment.|||mm||Standard Deviation|Mean
2756782|NCT00830128|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Up to 53 weeks|All participants who received at least 1 dose of the study medication.|||Participants|||Number
2756783|NCT00830115|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Participants|||Number
2756784|NCT00830115|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Participants|||Number
2756785|NCT00830115|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2756786|NCT00830115|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2756787|NCT00830115|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2756788|NCT00830115|Secondary|Patient's Assessment of Nausea for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 809~Day 1 = 798~Day 2 = 776~Day 3 = 761~Day 4 = 743~Day 5 = 738~Day 6 = 732"|||Units on a scale||Standard Deviation|Mean
2756789|NCT00830115|Secondary|Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 798~Day 1 = 782~Day 2 = 769~Day 3 = 759~Day 4 = 752~Day 5 = 739~Day 6 = 738"|||Units on a scale||Standard Deviation|Mean
2756790|NCT00830115|Secondary|Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 887~Day 1 = 867~Day 2 = 846~Day 3 = 823~Day 4 = 801~Day 5 = 784~Day 6 = 773"|||Units on a scale||Standard Deviation|Mean
2756791|NCT00830115|Secondary|Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 903~Day 1 = 891~Day 2 = 877~Day 3 = 843~Day 4 = 823~Day 5 = 791~Day 6 = 781"|||Units on a scale||Standard Deviation|Mean
2756792|NCT00830115|Secondary|Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 908~Day 1 = 906~Day 2 = 890~Day 3 = 876~Day 4 = 861~Day 5 = 842~Day 6 = 834"|||Units on a scale||Standard Deviation|Mean
2756793|NCT00830115|Primary|Physician's Assessment of Sleep Disturbances|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2756796|NCT00830076|Secondary|Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations|Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2||||mg/dL||95% Confidence Interval|Least Squares Mean
2756797|NCT00830076|Secondary|β-cell Sensitivity|"β-cell sensitivity was defined as the incremental post-prandial~4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC."|6 hour post-dose (4 hour postmeal) on Day 2|Beta-cell sensitivity was not calculated for 1 participant following the administration of sitagliptin alone and metformin alone due to missing insulin data.|||(ng/min)/(mg/dL)*10^ -3||95% Confidence Interval|Least Squares Mean
2756798|NCT00830076|Primary|Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations|Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2||||picomolar||95% Confidence Interval|Least Squares Mean
2756799|NCT00830037|Secondary|Proteinuria|Proteinuria was estimated using measurements of urinary protein and creatinine before iron administration at baseline and at periodic intervals thereafter. Mean change from baseline log urinary protein/creatinine ratio (g/g) is reported at 2 years.|Baseline, 2 years||||g/g||95% Confidence Interval|Mean
2756800|NCT00830037|Primary|Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron|Plasma clearance of iothalamate was measured by administering an IV bolus of 5 mL of iothalamate meglumine and sampling 2 mL of blood at 0, 5, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, and 300 min after injection. Iothalamate was measured by high-performance liquid chromatography. Plasma clearance was calculated using a two-pool model using validated pharmacokinetic software. The mean modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) in each group (IV iron vs. oral iron) was then calculated after adjustment for baseline log urinary protein/creatinine ratio.|Baseline, 2 years|Modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) was calculated for each group (IV iron vs. oral iron) after adjustment for baseline log urinary protein/creatinine ratio.|||Slope (ml/min per 1.73m2 per year)|||Number
2756801|NCT00830024|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756802|NCT00830024|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756803|NCT00830024|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756804|NCT00829998|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756805|NCT00829998|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756806|NCT00829998|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756807|NCT00829985|Secondary|Percent of Participants With the Occurrence of Adverse Events (AE)|Percent of participants who experienced at least one adverse event|Participant enrollment to end of study (up to 6 months post-baseline)|Safety population|||percentage of population|||Number
2756808|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Percent antibody binding||95% Confidence Interval|Mean
2756809|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Percent antibody binding||95% Confidence Interval|Mean
2756810|NCT00829985|Secondary|Difference in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Mean
2756811|NCT00829985|Primary|Difference in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Mean
2756812|NCT00829933|Secondary|Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )||12 weeks|||||||
2756813|NCT00829933|Secondary|Plasma DU-176 Concentration||12 weeks|||||||
2756817|NCT00829933|Primary|Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.|The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.|12 weeks|Primary endpoint analyzed for subjects who proceeded to treatment period in FAS.|||percent of subjects with bleeding event||95% Confidence Interval|Number
2756818|NCT00829868|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756819|NCT00829868|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756820|NCT00829868|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756821|NCT00829829|Secondary|Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
2756822|NCT00829829|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flare days per participant was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||Gout flare Days||Standard Deviation|Mean
2756823|NCT00829829|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||percentage of participants|||Number
2756824|NCT00829829|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||percentage of participants|||Number
2756825|NCT00829829|Secondary|Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)|Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IVRS at randomization (as randomized).|||modified gout flares||Standard Deviation|Mean
2756826|NCT00829829|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||Number of Gout flares per participant||Standard Deviation|Mean
2756827|NCT00829790|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756828|NCT00829790|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756831|NCT00829764|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2756832|NCT00829764|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2756833|NCT00829738|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
2756834|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
2756835|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Constipation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756836|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756837|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756838|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
2756839|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756840|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756841|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756842|NCT00829738|Primary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
2756843|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756844|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756845|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2756846|NCT00829712|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756847|NCT00829712|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756848|NCT00829712|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756849|NCT00829686|Secondary|Recurrence Rates|recurrence of abscess in previous or new location within 30 days|30 days||||participants|||Number
2756850|NCT00829686|Primary|Clinical Improvement at 7 Days After Incision and Drainage|improving wound without evidence of fever, worsening cellulitis or induration|7 days||||participants|||Number
2756851|NCT00829673|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756852|NCT00829673|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756855|NCT00829530|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)for Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756856|NCT00829530|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756857|NCT00829530|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756858|NCT00829530|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756859|NCT00829530|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756860|NCT00829504|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756861|NCT00829504|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756862|NCT00829504|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756863|NCT00829452|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) for Ramiprilat.|Informational comparison of AUc0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756864|NCT00829452|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756865|NCT00829452|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756866|NCT00829452|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2756867|NCT00829452|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2756868|NCT00829439|Primary|Maximum Dose of Levodopa/Carbidopa That Can be Tolerated (Without Any Dose Limiting Toxicity) by at Least 3 Subjects.||1 week||||mg/kg/day|||Number
2756869|NCT00829426|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period||||ng*h/mL||Standard Deviation|Mean
2756870|NCT00829426|Primary|Bioequivalence Based on AUC0-inf|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period||||ng*h/mL||Standard Deviation|Mean
2756871|NCT00829426|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 72 hour period||||ng/mL||Standard Deviation|Mean
2756872|NCT00829413|Secondary|Inter-reader Agreement|"Kappa statistic based on assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately and computation for the percentage agreement within two categories: 3 out of 3 readers agree and 2 out of 3 readers agree."|24 hours to 6 months||||Percentage of agreement|||Number
2756873|NCT00829413|Secondary|Specific Diagnosis of Benign FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.|||Benign lesions|Benign lesions to be characterized||Number
2756874|NCT00829413|Secondary|Specific Diagnosis of Malignant FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 119 ITD participants with malignant lesions based on the truth standard, only 94 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions.|||Malignant lesions|Malignant lesions to be characterized||Number
2756875|NCT00829413|Secondary|Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound|"Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100."|24 hours to 6 months|Among the 259 ITD participants, the number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent negative lesions by ultrasound|Negative lesions|95% Confidence Interval|Number
2756876|NCT00829413|Secondary|Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound|"Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up.~Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100."|24 hours to 6 months|Among the 259 ITD participants, the overall number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent positive lesions by ultrasound|Positive lesions|95% Confidence Interval|Number
2756877|NCT00829413|Secondary|Accuracy: Percentage of True Positive and True Negative Among All Lesions|"Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population.~Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and truth standard.~True negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100."|24 hours to 6 months|259 participants in the ITD population|||Percent true positive and negative lesio|Total lesions|95% Confidence Interval|Number
2756878|NCT00829413|Primary|Specificity: Percentage of True Negative Lesions Among All Benign Lesions Per Truth Standard'|"Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population.~Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard.~Among the 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100."|24 hours to 6 months|Among the 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard and were were included for specificty.|||Percentage of true benign lesions|Benign lesions|95% Confidence Interval|Number
2756879|NCT00829413|Primary|Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard|"Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs) using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-diagnose (ITD) population. Unit of analysis was the lesion, equivalent to subject, since each subject had a single lesion to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: CE-CT and/or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100"|24 hours to 6 months|Among 259 ITD subjects, 119 were malignant by truth standard and were included for sensitivity.|||Percentage of true positive lesions|Malignant lesions|95% Confidence Interval|Number
2756880|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 36 weeks post-baseline comparing CBT to Education.~0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed"|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36 week post treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
2756881|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 36 weeks post-baseline comparing CBT to Education.~Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
2756882|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms~Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
2756883|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 12 weeks post-baseline combaring CBT and ED.~0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment; making the number of participants analyzed differant than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
2756884|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 12 weeks post-baseline comparing CBT to Education.~Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
2756885|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms~Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that completed baseline data completed 12 week post treatment assessments; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
2756886|NCT00829309|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
2756887|NCT00829309|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one subject could not be included in the AUC0-inf calculation for Pravachol®.|||ng*h/mL||Standard Deviation|Mean
2756888|NCT00829309|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2756889|NCT00829296|Secondary|Change in Pulse Pressure Amplification|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure).|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||ratio||Standard Deviation|Mean
2756890|NCT00829296|Secondary|Change in Augmentation Index|Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||percent (%)||Standard Deviation|Mean
2756891|NCT00829296|Secondary|Change in Pulse Wave Velocity (PWV)|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||m/s||Standard Deviation|Mean
2756892|NCT00829296|Primary|Change in Central Systolic Blood Pressure (SBP)|Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||mmHg||Standard Deviation|Mean
2756893|NCT00829283|Secondary|BMI|The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.|12 months follow-up post-treatment||||kg/m^2||Standard Deviation|Mean
2756894|NCT00829283|Primary|Number of Subjects Who Reached Binge Eating Remission|Binge Remission (abstinence from binge eating)|12 months follow-up||||participants|||Number
2756895|NCT00829244|Secondary|Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome|Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).|up to 9 month (following the end of treatment)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||participants|||Number
2756896|NCT00829244|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment until Day 15-20 Post-hCG|Safety population included all the participants who were randomized.|||participants|||Number
2756897|NCT00829244|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||percentage of participants|||Number
2756898|NCT00829244|Secondary|Serum Progesterone (P4) Levels||End of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||nmol/L||Standard Deviation|Mean
2756899|NCT00829244|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as 2 or more fetal hearts with activity.|Day 35-42 Post-hCG|The modified ITT population. Number of participants analyzed (N) signifies those participants who were evaluated for this outcome measure.|||participants|||Number
2756900|NCT00829244|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||percent sacs per embryo||Standard Deviation|Mean
2756901|NCT00829244|Secondary|Number of Participants With Fetal Sacs and Fetal Hearts|Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||participants|||Number
2756902|NCT00829244|Secondary|Percentage of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.|Start of treatment until Day 15-20 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||percentage of participants|||Number
2756903|NCT00829244|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment|Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.|Start of treatment until Day 15-20 post-hCG|All the randomized participants were analyzed for this outcome measure (N=200).|||Participants|||Number
2756904|NCT00829244|Secondary|Total Number of GONAL-f® Stimulation Treatment Days||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||days||Standard Deviation|Mean
2756905|NCT00829244|Secondary|Mean GONAL-f® Daily Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||IU||Standard Deviation|Mean
2756906|NCT00829244|Secondary|Total GONAL-f® Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||IU||Standard Deviation|Mean
2756907|NCT00829244|Primary|Number of Oocytes Retrieved Per Participant|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)|The modified Intention-To-Treat (ITT) population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||oocytes||Standard Deviation|Mean
2756908|NCT00829179|Primary|Change in Exhaled Nitric Oxide From Baseline to Week 12|The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug)|13 weeks||||parts per billion (ppb)||Standard Deviation|Mean
2756932|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post Synflorix booster vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2757293|NCT00825734|Secondary|Objective Response Rate|Objective Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).|every 9 weeks until discontinuation of treatment|Includes patients treated at the Phase II dose who were evaluable for response|||patients|||Number
2756909|NCT00829166|Secondary|Time to Symptom Progression|"Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.|||Months||95% Confidence Interval|Median
2756910|NCT00829166|Secondary|Percentage of Participants With Symptom Progression|"Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.|||percentage of participants|||Number
2756911|NCT00829166|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
2756912|NCT00829166|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
2756913|NCT00829166|Secondary|Percentage of Participants With Clinical Benefit as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2756914|NCT00829166|Secondary|Duration of Objective Response (DOR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2756976|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8|"Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?."|Week 8|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756915|NCT00829166|Secondary|Percentage of Participants With Objective Response (OR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2756916|NCT00829166|Secondary|PFS as Assessed by the Investigator|Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
2756917|NCT00829166|Secondary|Percentage of Participants With PD or Death as Assessed by the Investigator|PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
2756918|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 2|2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.|Year 2|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants||95% Confidence Interval|Number
2756919|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 1|1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.|Year 1|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants||95% Confidence Interval|Number
2756920|NCT00829166|Primary|Overall Survival: Final Analysis|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
2756921|NCT00829166|Primary|Percentage of Participants Who Died: Final Analysis|The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
2756922|NCT00829166|Primary|Overall Survival: Second Interim Analysis (Co-primary Endpoint)|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
2756923|NCT00829166|Primary|Percentage of Participants Who Died: Second Interim Analysis|The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
2756933|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post-primary vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2757363|NCT00824733|Primary|PF-03512676 Augments Antibody Mediated Cytoxicity (ADCC)Against Trastuzumab-coated Target Cells in Metastatic HER2 Overexpressing Breast Cancer.||up to 18 weeks|Samples were not analyzed for primary endpoint due to the sample numbers being too small. No data were collected from the samples.||||||
2756924|NCT00829166|Primary|Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)|Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
2756925|NCT00829166|Primary|Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)|PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
2756926|NCT00829049|Secondary|Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16|Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percent Change||Full Range|Median
2756927|NCT00829049|Secondary|Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12|Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.|Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percentage of patients|||Number
2756928|NCT00829049|Secondary|Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16|Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.|Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percentage of patients|||Number
2756929|NCT00829049|Primary|Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).|Baseline, Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percent Change||Full Range|Median
2756930|NCT00829036|Primary|Mean Percent (Prototype / Baseline) Time|The outcome measure for each subject is the mean of the (Prototype Time / Baseline Time) across 12 trials. The outcome measure for the experiment is the mean of 24 individual subject mean scores. This mean outcome measure is expressed as a percentage of the mean Baseline Time, where improved performance is represented by a percentage that is less than 100 percent of the Baseline Time. The lower the percentage, the better the performance improvement.|2 hours|Power Analysis: Using Repeated Measures ANOVA for the 24 participants assuming a minimum correlation between repeated measures of .7, we chose our analyses will be sensitive to a medium between factor effect size of f=.33 with power set to .80 and alpha level set to .05.|||Percentage of Baseline Performance Time||Standard Deviation|Mean
2756931|NCT00829010|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2756975|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6|"Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?."|Month 6|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756934|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:~drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2756935|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2756936|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:~drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2756937|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2756938|NCT00829010|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs|Acquisition of new H. influenza* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented|||Participants|||Count of Participants
2756939|NCT00829010|Secondary|Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.|Positive cultures of H. influenza* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented|||Swabs|||Number
2756940|NCT00829010|Secondary|Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples|Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals' designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented|||U/mL||95% Confidence Interval|Geometric Mean
2756941|NCT00829010|Secondary|Concentrations of Antibodies Against Measles|Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.|1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2756942|NCT00829010|Secondary|Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.|Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.|1 month after the administration of the second vaccine dose (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||U/mL||95% Confidence Interval|Geometric Mean
2756943|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.|"Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL.~As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||mIU/mL||95% Confidence Interval|Geometric Mean
2756944|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA|"Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL.~As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month following primary immunization (at Month 3)|According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2756945|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month after the booster vaccination (at Month 15)|The ATP cohort for immunogenicity at 15 -18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||µg/mL||95% Confidence Interval|Geometric Mean
2756946|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2756947|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicityat 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2756948|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2756949|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). The cut-off of the assay is 0.1IU/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The According-To-Protocol cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||IU/mL||95% Confidence Interval|Geometric Mean
2756950|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2756951|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2756952|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2756953|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2756954|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|ATP cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2756955|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2756956|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2756957|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2756958|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2756959|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2757832|NCT00821951|Primary|The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.|maximum tolerated dose of vorinostat when given concurrently with radiation|1 Year|All participants who received any drug|||mg|||Number
2756960|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/ml||95% Confidence Interval|Geometric Mean
2756961|NCT00829010|Primary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Participants|||Count of Participants
2756962|NCT00828984|Secondary|Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
2756963|NCT00828984|Secondary|Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
2756964|NCT00828984|Secondary|Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|Change in activated caspase-3 (apoptosis) expression as measured in endoscopically normal (non-ACF) mucosal biopsies|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
2756965|NCT00828984|Secondary|Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on mucosal epithelial proliferation (Ki-67)|6 months - baseline|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups.|||ng/ml||Standard Deviation|Mean
2756966|NCT00828984|Secondary|Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||Aberrant Crypt Foci||Standard Deviation|Mean
2756967|NCT00828984|Primary|Difference (After Treatment Minus Before Treatment) of EGFR Expression|Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
2756968|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12|"Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test."|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants|||Number
2756969|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6|"Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test."|Month 6|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants|||Number
2756970|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8|"Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test."|Week 8|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants|||Number
2756971|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756972|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756973|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756974|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12|"Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?."|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756977|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12|"Participants with Yes response to a question which stated The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?."|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756978|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12|"Participants with Yes response to a question which stated The self-test have increased my motivation for taking my medication for hyperlipidemia?. The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test."|Month 12|The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2756979|NCT00828841|Secondary|Overall Survival by Histology||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Subjects were stratified by histology prior to randomization to a treatment arm.|||Months||95% Confidence Interval|Median
2756980|NCT00828841|Secondary|1-year Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.||||percentage of participants||95% Confidence Interval|Number
2756981|NCT00828841|Primary|Overall Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Two subjects in Arm A were censored due to negative event intervals.|||Months||95% Confidence Interval|Median
2756982|NCT00828750|Secondary|Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy|Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS|||percentage of participants|||Number
2756983|NCT00828750|Secondary|Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication|Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.|||percentage of participants|||Number
2756984|NCT00828750|Secondary|Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication|Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.|||percentage of participants|||Number
2756985|NCT00828750|Secondary|Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals|Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)|FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.|||weeks||Full Range|Median
2756986|NCT00828750|Secondary|Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)|Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.|||percentage of participants|||Number
2756987|NCT00828750|Secondary|Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.|||Gi/L||Full Range|Median
2756988|NCT00828750|Secondary|Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.|||percentage of participants|||Number
2756989|NCT00828750|Primary|Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|Safety Population (SP): all participants who received at least one dose of study medication|||participants|||Number
2756990|NCT00828711|Secondary|Time to Onset of Active Labor||Interval from study drug administration to active labor (average 12 hours)|Kaplan-Meier Estimates for Time to Onset of Active Labor presented (Modified Intention-to-Treat population). Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery (Censored subjects = MVI 100: 5; MVI 150: 7; MVI 200: 8)|||minutes||95% Confidence Interval|Median
2756991|NCT00828711|Secondary|Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.|From study drug insertion up to 2 hours post study drug removal|The plan was to enrol 24 subjects to the pharmacokinetic (PK) arm of the study. Only 3 subjects enrolled in the PK arm; there were too few subjects and too few samples available. Due to insufficient data, no statistical analysis was possible. Only misoprostol acid levels for each blood sampling timepoint for each subject was determined.|||PK Parameters|||Number
2756992|NCT00828711|Secondary|Use of Oxytocin|Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.|At least 30 minutes after study drug removal|Percentage of subjects who required pre-delivery oxytocin is presented (Modified Intention-to-Treat population).|||percentage of participants||95% Confidence Interval|Number
2756993|NCT00828711|Secondary|Cervical Ripening Using Composite Measure of Success|"Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:~Increase from baseline in modified Bishop score ≥3; or~Achievement of modified Bishop score of ≥6; or~Vaginal delivery."|12 hours after insertion of drug|Percentage of subjects with cervical ripening success at 12 hours is presented (Modified Intention-to-Treat population).|||percentage of participants||95% Confidence Interval|Number
2756994|NCT00828711|Secondary|Proportion of Cesarean Delivery||Interval from study drug administration to cesarean delivery (average 24 hours)|Percentage of subjects who had a cesarean delivery during the first hospitalization (safety population) is presented.|||percentage of participants||95% Confidence Interval|Number
2756995|NCT00828711|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48 - 72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.|||percentage of participants|||Number
2756996|NCT00828711|Secondary|Time to Vaginal Delivery||Interval from study drug administration to delivery (average 24 hours)|Kaplan-Meier Estimates are based on Modified Intention-to-Treat (MITT) population.Subjects who had a cesarean, discharged prior to delivery or withdrew consent during first hospitalization were censored (MVI 100: 37, MVI 150: 39, MVI 200: 31) using the longest time interval from study drug administration to cesarean or to Labor & Delivery discharge|||minutes||95% Confidence Interval|Median
2756997|NCT00828711|Primary|Proportion of Women Delivering Vaginally||Interval from study drug administration to 24 hours|Analysis based on Modified Intention-to-Treat (MITT) population who delivered vaginally. Percentage of subjects who delivered vaginally is presented.|||percentage of participants||95% Confidence Interval|Number
2756998|NCT00828672|Secondary|Death Rates and Overall Survival|Counts and proportions of patients deceased (post-study).|up to 5 years|Intent to treat in follow up (one patient in Arm 1 lost to follow up).|||Participants|||Count of Participants
2756999|NCT00828672|Secondary|Recurrence Rates and Disease Free Survival|Counts and proportions of patients experiencing recurrence of disease (local and distant).|up to 5 years|Intent to treat (one patient lost to follow-up)|||Participants|||Count of Participants
2757000|NCT00828672|Secondary|Types and Numbers of Adverse Events - General Overview|Adverse events graded as per NCI CTCAE (US National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0. All Serious Adverse Events occurrences are reported and counts are summarized here; all Adverse Events (all grades) related and not related to study treatment are reported and summarized here; all severe laboratory events (hematology and biochemistry Gr 3 and higher) are reported and summarized here; all severe postoperative complications (Gr 3 and higher) occurred within the first month post surgery are reported and summarized here. See section Adverse events for details.|continuous up to 1 year|Intent to treat|||counts of events|||Number
2757001|NCT00828672|Secondary|Clinical Response Rate|"Baseline tumour measurements were performed within 4 weeks prior to treatment start (RECIST). The same methods of assessment (CT and/or MRI) were used for each measurable lesion at baseline and during follow-up.~Complete Response (CR) is disappearance of all clinical and radiological evidence of tumour (both target and non-target lesions).~Partial Response (PR) is at least a 30% decrease in the sum of LD of target lesions, taking as reference the baseline sum of tumour longest diameters (LD).~Stable Disease (SD) is steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD) is at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions constitutes PD. In exceptional circumstances, unequivocal progression of non-target lesions was considered evidence of PD."|3 months|Intent to treat, all registered patients|||Participants|||Count of Participants
2757011|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before 7th acupuncture treatment|All participants completing 6 acupuncture treatments were analysed|||units on a scale||Standard Deviation|Mean
2757012|NCT00828464|Secondary|Change in Subject's Visual Analogue Assessment Scale From Baseline to Day 15|Mean change in subject's visual analogue assessment scale from baseline to day 15. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 15|ITT|||Units on a scale||Standard Deviation|Mean
2757002|NCT00828672|Secondary|Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery.|Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100.|4 months|Centrally reviewed subset|||Participants|||Count of Participants
2757003|NCT00828672|Secondary|Number of Participants With Histopathologic R0 and Negative CRM Resection|Histopathologic R0 resection rate was defined as margins histologically negative for tumour involvement after resection. The circumferential resection margin (CRM) is considered to be involved if microscopic tumour is present <1mm from or at the inked circumferential or radial resection margin. Data on quality of mesorectal excision were expected but not collected consistently.|4 months|Patient in Arm 2 that discontinued chemoradiotherapy due to major toxicity and had surgery off protocol is counted here as well|||Participants|||Count of Participants
2757004|NCT00828672|Primary|Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery.|Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100.|4 months|Patients who had undertaken surgery and had pathology materials available for central review (centrally reviewed subset)|||percentage of cases||95% Confidence Interval|Number
2757005|NCT00828568|Primary|Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline|"Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.~Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Intention to Treat (ITT) Population|||Participants|||Number
2757006|NCT00828568|Secondary|Patients Reporting at Least One Adverse Event|For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.|24 weeks|Safety group includes all patients who received a single dose|||Participants|||Number
2757007|NCT00828568|Primary|Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%|"Uses per protocol (PP) population.~Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Per Protocol (PP) population|||Participants|||Number
2757008|NCT00828542|Secondary|Maternal (Clinical and Metabolic) and Neonatal (Clinical) Safety Regarding the Use of the Etonogestrel Implant During the Immediate Postpartum Period and the First 12 Weeks Postpartum|Evaluation during the immediate postpartum period was performed at the hospital 24-48 h after delivery, in the morning and after a 12-h fast. Women and newborns were both weighed (Kg), and the blood pressure (mmHg), waist circumference (WC) (cm) and height (m) of the women were each measured by the same observer. Peripheral blood samples (20 mL) were collected and processed within 2 h after being collected. After clotting the serum, samples were centrifuged at room temperature for 10 min, and the sera were stored at −80°C until they were used for the simultaneous determination of all variables except for the complete blood count, which was performed before clotting. The following variables were analyzed: fasting serum glucose; total cholesterol (TC), high density lipoprotein (HDL) cholesterol, and triglycerides (TG), and low density lipoprotein (LDL) cholesterol|12 weeks|||||||
2757009|NCT00828542|Primary|Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks|"Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods.~APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate.~The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma.~Thus, nAPCsr >1.0 indicated APC resistance."|12 weeks||||ratio||Standard Deviation|Mean
2757010|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before the 13th acupuncture treatment|This was the number of participants who continued to, and completed, Series 2 of the treatments|||units on a scale||Standard Deviation|Mean
2757013|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI)for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
2757014|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
2757015|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
2757016|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
2757017|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 15 with at least a 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
2757018|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Palm of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
2757019|NCT00828464|Secondary|Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
2757020|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers|"Proportion of Subjects at day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
2757021|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
2757022|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of subjects at day 15 with at least 1-Grade improvement in the Hand Eczema Severity Index Score (HESI) for all symptoms present at baseline - Finger Tips. The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
2757023|NCT00828464|Secondary|Change in Subject's Visual Analogue Assessment Scale|Mean change in subject's visual analogue assessment scale from baseline to day 8. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 8|ITT. Twenty-nine of the 30 subjects enrolled on this study had results for this endpoint on day 8. Thirty of the 30 subjects enrolled had results for this same assessment at the day 15 visit.|||Units on a scale||Standard Deviation|Mean
2757024|NCT00828464|Primary|Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score|"Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants.~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 15|Intent-to-treat (ITT).|||Percentage of Participants|||Number
2757025|NCT00828464|Secondary|Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.|"Please note that the proportion of participants is being reported as a percentage of participants.~Investigator's Static Global Assessment Score (ISGA) At least 1-grade improvement (%) at Day 8~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 8|ITT|||Percentage of Participants|||Number
2757026|NCT00828451|Secondary|EGF Gene Sequencing|Identification of computationally predicted functional variants in EGF gene|Sampling occurred on average day of life 9 with a range from day of life 7 to 21|29 subjects were enrolled; 11 did not complete the study and were not analyzed|||percentage of participants with variant|||Number
2757027|NCT00828451|Primary|Urinary EGF Protein Levels|Urinary EGF protein levels obtained from free flowing urine samples retrieved from subject diaper were analyzed by commercially available EGF ELISA kit (R &D systems Inc). EGF protein levels were normalized to milligrams of creatinine in urine, and expressed as nanograms of EGF protein per milligram of urinary creatinine.|Sampling occurred on average day of life 9 with a range from day of life 7 to 21|29 subjects were enrolled; 11 did not complete the study and were not analyzed|||nanograms of EGF/mg of creatinine||Full Range|Median
2757028|NCT00828451|Primary|Salivary EGF (Epidermal Growth Factor) Protein Levels|Salivary EGF protein levels obtained from oral swabs were analyzed by commercially available EGF ELISA kit (R &D systems Inc). EGF protein levels were normalized to micrograms of protein in saliva, and expressed as picogram of EGF protein per microgram of total salivary protein.|Sampling occurred on average day of life 9 with a range from day of life 7 to 21|29 subjects were enrolled with 11 not completing the study and not analyzed due to lack of specimens|||picograms EGF/ microgram of protein||Full Range|Median
2757029|NCT00828412|Primary|Change From Baseline in Three Item Severity Score|The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.|Baseline to 6 weeks|All subjects with data were included in the analysis. No imputation was done for missing data.|||units on a scale||Standard Deviation|Mean
2757030|NCT00828347|Primary|Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level||Participants were followed for 24 weeks||||participants|||Number
2757031|NCT00828321|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2757032|NCT00828321|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2757033|NCT00828321|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril.|Bioequivalence based on AUC0-t for Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2757034|NCT00828321|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril|Bioequivalence based on AUC0-t of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2757035|NCT00828321|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril|Bioequivalence based on Cmax of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2757036|NCT00828308|Primary|Prostate-Specific Antigen (PSA) Response|Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone|after 12 weeks of ixabepilone||||participants|||Number
2757037|NCT00828295|Secondary|Proportion of Patients With Complete Response 0-24 Hours|Complete Response defined as no vomiting, no retching, and no use of rescue medication|0-24 hours|Full Analysis Set|||percentage of patients||95% Confidence Interval|Number
2757038|NCT00828295|Primary|Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively||0-72 hours post-operatively|The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.|||percentage of patients||95% Confidence Interval|Number
2757833|NCT00821886|Secondary|Overall Survival|Defined as the time between Day 1 Cycle 1 to date of death from any cause.|approximately 48 months||||months||95% Confidence Interval|Number
2757039|NCT00828204|Other Pre-specified|Mean Pain Score After Injection|Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).|Day 1, Day 8, Day 15, Day 22|Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.|||scores on a scale||Standard Deviation|Mean
2757040|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe|Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?|Day 23|Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.|||percentage of participants|||Number
2757041|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector|"Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: Did you have any difficulty with your injection? The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented."|Day 1, Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.|||percentage of participants|||Number
2757042|NCT00828204|Other Pre-specified|Mean Score for Initial Subset on Autoinjector Instructions Grading Scale|"Participants in the Initial Subset were asked to answer the question How satisfied are you with the presentation of the autoinjector instructions? on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied)."|Day 8|Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.|||scores on a scale||Standard Deviation|Mean
2757043|NCT00828204|Other Pre-specified|Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective|Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.|Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.|||percentage of participants|||Number
2757044|NCT00828204|Other Pre-specified|Mean Score for Ease of Use Grading Scale|Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).|Day 1, Day 8, Day 15, Day 22|Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.|||scores on a scale||Standard Deviation|Mean
2757045|NCT00828204|Other Pre-specified|Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector|The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.|Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)|Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.|||percentage of participants|||Number
2757046|NCT00828204|Other Pre-specified|Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector|"Number of participants in the Initial Subset who answered yes to the question Were you satisfied with this single-use injector? on the Subject Satisfaction Questionnaire."|Day 23|Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.|||participants|||Number
2757047|NCT00828204|Primary|Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector|A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.|Day 22|Participants in the Main Subset who received an injection of Avonex prefilled syringe as a manual IM injection, at least 1 injection of Avonex prefilled syringe using the autoinjector, and had a completed Observation Form were included in the analysis. Missing data were not imputed. All analyses are based on observed data.|||percentage of participants||95% Confidence Interval|Number
2757048|NCT00828191|Secondary|Delivery Rate||nearly 9 months after treatment start|All randomized patients|||percentage of randomized patients|||Number
2757049|NCT00828191|Secondary|Implantation Rate|Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.|4-5 weeks after treatment start|Patient who had at least one embryo transferred.|||percentage of embryos transferred||Standard Deviation|Mean
2757050|NCT00828191|Primary|Ongoing Pregnancy Rate||10 weeks after treatment start|All randomized patients were included in the analysis|||percentage of randomized patients|||Number
2757051|NCT00828178|Secondary|Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.|The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.|pre-treatment(baseline) and post-treatment (after 12 weeks)||||ng/ml||Standard Deviation|Mean
2757052|NCT00828178|Secondary|Effect of Omega-3 Versus Placebo on Disease Activity in SLE.|"The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks).~SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score.~PGA - range 0-3, high score indicates high disease activity."|pre-treatment(baseline) and post-treatment (after 12 weeks)||||Units on a scale||Standard Deviation|Mean
2757053|NCT00828178|Primary|Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.|The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).|12 weeks|Patients who successfully completed the trial.|||cm||Standard Deviation|Mean
2757054|NCT00828139|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Ant CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2757055|NCT00828139|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)|"The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Disease assessment for response were performed every 6 weeks, up to 2 years.||||proportion of participants||90% Confidence Interval|Number
2757056|NCT00828139|Secondary|Overall Survival|Estimated to within at least 15% (95% confidence interval).|Weekly, up to 2 years.||||months||90% Confidence Interval|Median
2757057|NCT00828139|Primary|Progression-free Survival (PFS)|"From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.~Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration."|Disease assessments were performed every 6 weeks, up to 2 years.||||Months||90% Confidence Interval|Median
2757058|NCT00828113|Primary|Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52|Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52|7-day point prevalence|Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status.|||participants|||Number
2757059|NCT00828074|Secondary|Toxicity Profile|Number of Participants with Treatment-Related Grade 3 & 4 Toxicities for Sorafenib and Vinorelbine Combination|28 days following the last course of treatment||||participants|||Number
2757060|NCT00828074|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).|||Months||95% Confidence Interval|Median
2757061|NCT00828074|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.|After 2 cycles of treatment, up to 2 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion). Patients who complete 2 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 2 cycles of therapy on the Phase II portion of the study.|||percentage of participants|||Number
2757062|NCT00828074|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression, up to 5 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).|||Months||95% Confidence Interval|Median
2757063|NCT00828074|Secondary|Progression-free Survival Rate at 4 Months|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months following the last course of treatment|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).|||percentage of participants|||Number
2757064|NCT00828074|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD) of Vinorelbine is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg/m^2|||Number
2757834|NCT00821886|Secondary|Disease-free Survival|Defined as the interval from the first date of study treatment until the date of tumor recurrence or death from any cause|expected average 18 months||||months||95% Confidence Interval|Median
2757065|NCT00828074|Primary|Number of Participants With at Least One Dose Limiting Toxicity in Phase I|Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy.|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
2757066|NCT00828061|Secondary|Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils|Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients with Slide Quality ≤ 3 (Slide Quality measured on a 6 point scale with values > 3 indicating a level of debris that interferes with cell typing and counting).|||Percentage of cells that are eosinophils||95% Confidence Interval|Least Squares Mean
2757067|NCT00828061|Primary|Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration|Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients as Treated|||Fold Change||95% Confidence Interval|Geometric Mean
2757068|NCT00828009|Secondary|Progression-free Survival|Progression-free survival was defined as the time from study registration to disease progression or death from any cause, whichever came first. If date of death was greater than 3 months after date of last disease assessment that showed progression-free, the patient was censored at the time of last disease assessment. Patients alive and without documented progression were censored at the date last known progression-free.|Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 years|Only eligible and treated patients are included in this analysis.|||months||95% Confidence Interval|Median
2757069|NCT00828009|Secondary|Overall Survival|Overall survival was defined as the time from the study registration until death from any cause. Patients who were alive or lost to follow-up at the time of analysis were censored at date last known alive.|Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 years|Only eligible and treated patients are included in the analysis.|||months||95% Confidence Interval|Median
2757070|NCT00828009|Primary|Proportion of Patients With Target Adverse Events for the Step 2 Treatment|The study is to evaluate the safety of the combination of tecemotide immunotherapy with bevacizumab. The target adverse events for the combined treatment are as follows: grade 4-5 hemorrhage, esophagitis, fistula, platelet count decrease (thrombocytopenia), encephalitis infection, or hepatic failure episodes.|Assessed every 3 weeks while on treatment and up to 5 years|All patients who received step 2 treatment|||proportion of participants||80% Confidence Interval|Number
2757071|NCT00827983|Secondary|Implantation Rate|Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.|Four to five weeks after oocytes retrieval|All the patients who had at least one embryo transferred|||percentage of embryos transferred||Standard Deviation|Mean
2757072|NCT00827983|Secondary|Delivery Rate and Live Birth Rate||nearly 9 month after treatment start|all the randomised patients were included in the analysis|||percentage of randomised patients|||Number
2757073|NCT00827983|Primary|Ongoing Pregnancy Rate at the End of the Study||10 weeks after treatment start|ITT population was analysed (i.e. all the randomised patients)|||percentage of randomized patient|||Number
2757074|NCT00827944|Secondary|Other Post-operative Complications||M12 after surgery|As Treated population|||participants|||Number
2757075|NCT00827944|Secondary|Return to Work and to Normal Daily Activities||Effective date|The analysis were performed on an As Treated (AT) population, with a 5% significance level.|||days||Standard Error|Mean
2757076|NCT00827944|Secondary|Wound Complications and Hernia Recurrences||M12 after surgery|The analysis were performed on an As Treated (AT) population, with a 5% significance level.|||participants|||Number
2757077|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)|Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).|M3, M12 after surgery|The analysis were performed on an As Treated population (AT), with a 5% significance level.|||units on a scale||Standard Deviation|Mean
2757078|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)|Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|M3, M12 after surgery|The analysis were performed on an As Treated (AT)population, with a 5% significance level.|||units on a scale||Standard Deviation|Mean
2757079|NCT00827944|Secondary|Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score|Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|3 months after surgery||||participants|||Number
2757080|NCT00827944|Secondary|Foreign Body Sensation|Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.|M1, M3, M12 months after surgery|The analysis were performed on an As Treated population, with a 5% significance level.|||participants|||Number
2757092|NCT00827918|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 4 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.|||Participants|||Number
2757081|NCT00827931|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||Participants|||Number
2757082|NCT00827931|Secondary|Hemoglobin Levels||End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||Gram/Deciliter (g/dL)||Standard Deviation|Mean
2757083|NCT00827931|Secondary|Percentage of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dL) hemoglobin or hematocrit value of 24 percent.|Up to Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||Percentage of participants||95% Confidence Interval|Number
2757084|NCT00827931|Secondary|Total Blood Loss as Assessed by the Gross' Formula|Gross' formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||mL||Standard Deviation|Mean
2757085|NCT00827931|Secondary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||mL||Standard Deviation|Mean
2757086|NCT00827931|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||mL||Standard Deviation|Mean
2757087|NCT00827931|Primary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Post-operation, Day 1, Day 2 up to drain removal|Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||milliliter (mL)||Standard Deviation|Mean
2757088|NCT00827918|Secondary|Mean Change From Baseline in PANSS Negative Subscale at Week 4|PANSS Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms. The Negative scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS negative subscale measurements between baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2757089|NCT00827918|Secondary|Mean Change From Baseline in PANSS Positive Subscale at Week 4|PANSS Positive scale assesses hallucinations, delusions and related symptoms. The Positive scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS positive subscale measurements between baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2757090|NCT00827918|Secondary|Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) at Week 4|CGI-S is a commonly used measure of symptom severity in treatment studies of participants with mental disorders. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.|Baseline and Week 4|Randomized participants with any CGI-S measurements between baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2757091|NCT00827918|Secondary|Percentage of Participants With Response at Week 4|Responders were defined as participants who demonstrated ≥ 20% improvement from baseline on the PANSS total score. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Week 4|Randomized participants with a PANSS measurement at Week 4.|||Percentage of participants|||Number
2757115|NCT00827632|Secondary|Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).||Screening (baseline) and follow-up 1 (exit)|We excluded participants who were not compliant with the study treatment (based on measuring serum hormone concentrations) from the analyses.|||mg/dL||Standard Deviation|Mean
2757093|NCT00827918|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 6 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.|||Participants|||Number
2757094|NCT00827918|Primary|Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) at Week 4|PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Baseline and Week 4|Randomized participants with any PANSS measurements between Baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2757095|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
2757096|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
2757097|NCT00827827|Primary|Change in Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
2757098|NCT00827827|Primary|Change in Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
2757099|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
2757100|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
2757101|NCT00827827|Primary|Change in Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
2757102|NCT00827827|Primary|Change in Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
2757103|NCT00827827|Primary|Change in Berg Balance Scale|This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points. Range is 0-56 and higher values represent a better outcome.|Baseline, 3 months|All participants for whom a Berg Score was recorded at Baseline and 3 months|||Scores on a scale||Standard Error|Mean
2757104|NCT00827827|Primary|Change in Peak Aerobic Capacity (VO2 Peak)||Baseline, 3 Months|All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months|||mls/kg/min||Standard Error|Mean
2757105|NCT00827827|Primary|Change in 10 Meter Walking Speed (Fastest)||Baseline, 3 Months|All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months|||meters/ second||Standard Error|Mean
2757106|NCT00827827|Primary|Change in 10 Meter Walking Speed (Self-Selected)||Baseline, 3 months|All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months|||meters/ second||Standard Error|Mean
2757107|NCT00827827|Primary|Change in 6-minute Walk Distance||Baseline, 3 Months|All participants for whom 6-minute walk distance was recorded at Baseline and 3 months|||feet||Standard Error|Mean
2757108|NCT00827827|Primary|Change in Leg Muscle Endurance (Non-Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months|||repetitions||Standard Error|Mean
2757109|NCT00827827|Primary|Change in Leg Muscle Endurance (Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 Months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months|||repetitions||Standard Error|Mean
2757110|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
2757111|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
2757112|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
2757113|NCT00827827|Primary|Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
2757114|NCT00827632|Secondary|Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.||24 hours during week 3 of follow-up cycle|Data were not available. No analysis performed.||||||
2757116|NCT00827632|Primary|Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.|"Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined):~no activity~potential activity~nonactive follicle-like structure~active follicle-like structure~luteinized unruptured follicle~ovulation~Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score."|Up to 8 biweekly visits from start of OCP therapy|Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese).|||Participants|||Number
2757117|NCT00827606|Secondary|Percentage of Participants by Study Drug Compliance Category|Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.|Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)|Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2757118|NCT00827606|Primary|Percent Change From Baseline in FMD|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.|Months 6, 12, 18, 24, 30 and 36/ET|FMD Set; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757119|NCT00827606|Primary|Flow-Mediated Dilatation (FMD) During the Study|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.|Baseline, Months 6, 12, 18, 24, 30 and 36/ET|FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit.|||% FMD||Standard Deviation|Mean
2757120|NCT00827606|Secondary|Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator||Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2757121|NCT00827606|Primary|Percent Change From Baseline in Age: Females|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757122|NCT00827606|Primary|Age (Years) During the Study: Females|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||years||Standard Deviation|Mean
2757123|NCT00827606|Primary|Percent Change From Baseline in Age: Males|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757124|NCT00827606|Primary|Age (Years) During the Study: Males|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||years||Standard Deviation|Mean
2757125|NCT00827606|Primary|Percent Change From Baseline in BMI: Females|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757126|NCT00827606|Primary|BMI (kg/m^2) During the Study: Females|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg/m^2||Standard Deviation|Mean
2757127|NCT00827606|Primary|Percent Change From Baseline in BMI: Males|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757128|NCT00827606|Primary|Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg/m^2||Standard Deviation|Mean
2757129|NCT00827606|Primary|Percent Change From Baseline in Weight: Females|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757130|NCT00827606|Primary|Weight (kg) During the Study: Females|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg||Standard Deviation|Mean
2757131|NCT00827606|Primary|Percent Change From Baseline in Weight: Males|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757132|NCT00827606|Primary|Weight (Kilograms [kg]) During the Study: Males|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg||Standard Deviation|Mean
2757133|NCT00827606|Primary|Percent Change From Baseline in Height: Females|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757134|NCT00827606|Primary|Height (cm) During the Study: Females|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||cm||Standard Deviation|Mean
2757135|NCT00827606|Primary|Percent Change From Baseline in Height: Males|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757136|NCT00827606|Primary|Height (Centimeters [cm]) During the Study: Males|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||cm||Standard Deviation|Mean
2757137|NCT00827606|Primary|Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage|Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.|Baseline, Months 6, 12, 18, 24, 30, and 36/ET|FAS; n=number of participants assessed for the specific parameter at a given visit.|||participants|||Number
2757138|NCT00827606|Primary|Percent Change From Baseline in Apo B|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757139|NCT00827606|Primary|Apoliprotein B (Apo B; g/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||g/L||Standard Deviation|Mean
2757140|NCT00827606|Primary|Percent Change From Baseline in Apo A-1|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757141|NCT00827606|Primary|Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||g/L||Standard Deviation|Mean
2757142|NCT00827606|Primary|Percent Change From Baseline in VLDL|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757143|NCT00827606|Primary|Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
2757144|NCT00827606|Primary|Percent Change From Baseline in Trigylcerides|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757145|NCT00827606|Primary|Trigylcerides (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
2757146|NCT00827606|Primary|Percent Change From Baseline in Total Cholesterol|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757147|NCT00827606|Primary|Total Cholesterol (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
2757148|NCT00827606|Primary|Percent Change From Baseline in HDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757149|NCT00827606|Primary|High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
2757150|NCT00827606|Primary|Percent Change From Baseline in LDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
2757151|NCT00827606|Primary|Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])|FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
2757152|NCT00827567|Primary|Time to Progression(TTP)|Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline|Each patient assessed at 8 weeks from start of study drug|||||||
2757153|NCT00827541|Secondary|Number of Participants With Eradication of Microbiological Pathogens|Evaluation of eradication after treatment with tigecycline included following microbiological pathogens: E. coli ESBL; K. pneumoniae ESBL; Bacteroides species RClin; S. aureus (MRSA); Enterococcus species (VRE); Enterobacter species RCef3; Serratia species RCef3; Proteus species ESBL; P. aeruginosa RCarb; A. baumannii RCarb.|Week 12|Data was not analyzed since the number of samples obtained for culture was very low.|||participants|||Number
2757154|NCT00827541|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 12|Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.|||participants|||Number
2757155|NCT00827541|Secondary|Number of Participants With Susceptible Microbiological Pathogens|Evaluation of susceptibility to the tigecycline treatment included: Escherichia coli Extended Spectrum Beta Lactamases (E. coli ESBL); Klebsiella pneumoniae (K. pneumoniae) ESBL; Bacteroides species resistant to clindamycin (RClin); Staphylococcus aureus (S. aureus) methicillin resistant S. aureus (MRSA); vancomycin resistant Enterococcus (VRE) species; Resistant to third generation cephalosporins (RCef3) Enterobacter species; RCef3 Serratia species; Proteus species ESBL; carbapenem resistant (RCarb) Pseudomonas aeruginosa (P. aeruginosa); Acinetobacter baumannii (A. baumannii) RCarb.|Baseline and Week 12|Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.|||participants|||Number
2757156|NCT00827541|Secondary|Percentage of Participants With Clinical Response of Cure|Cure was defined as complete resolution of infection symptoms and clinical signs of the disease to the extent that no further antibiotic treatment was required, as assessed by the attending physician.|Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment|Intent-To-Treat (ITT) population included all evaluable participants who had at least one dose of study medication and one evaluation visit. 'n' signifies those participants who were evaluated for this measure at specified time points for each group respectively.|||percentage of participants|||Number
2757157|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study|Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.|Baseline to 2 weeks|The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.|||Participants|||Number
2757158|NCT00827502|Secondary|Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate|Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).|Baseline to 3 months|FAS|||cost (in Indian Rupees) per participant||Full Range|Median
2757159|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study|Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.|Baseline to 2 weeks|The full analysis set (FAS) included all subjects who received at least one dose of study medication.|||participants|||Number
2757160|NCT00827372|Secondary|Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions)|"The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1.~Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2.~Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome"|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline/Cycle 1, Day 1, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.|||Units on a scale||Standard Deviation|Mean
2757161|NCT00827372|Secondary|Number of Patients With Trt Related Grade 2+ AEs|This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special').|End of Treatment|All treated patients|||participants|||Number
2757162|NCT00827372|Secondary|Change in Impedance or ECF Volume in the Arm|"Arm impedance was reported at two baseline readings and for Cycle 2, Day 1.~To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm"|Baseline, and Cycle 2, Day 1|All patients with non-missing results. This includes 8 patients at the first baseline, 10 patients at the second baseline, and 7 patients at Cycle 2, Day 1.|||ratio||Standard Deviation|Median
2757163|NCT00827372|Secondary|Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm|"Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm.~To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer)"|First 24 hours after drug was administered|All patients with non-missing results at both baseline and at 24 hours.|||mm Hg||Standard Deviation|Mean
2759414|NCT00810901|Primary|Designated Organ Donor Status on Driver's License|Number of students who reported not being donor at baseline but were donor at 12 months follow-up|12 months|t-test|||participants||95% Confidence Interval|Number
2757164|NCT00827372|Primary|Change in Volume Ipsilateral Lymphedema in Arm|The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days).|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.|||mL||Standard Deviation|Mean
2757165|NCT00827255|Secondary|Schirmer's Test at Month 12|Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.|Month 12|ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded.||||||
2757166|NCT00827255|Primary|Percentage of Patients With Complete Clearing of Corneal Staining at Month 12|Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.|Month 12|ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.|||Percentage of Patients|||Number
2757167|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume|The amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL||Standard Deviation|Mean
2757168|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry|Vcomp was defined as the volume of urine voided (measured in mL using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL||Standard Deviation|Mean
2757169|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry|Qmean was defined as the mean urine flow rate (measured in mL/sec using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL/sec||Standard Deviation|Mean
2757170|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry|Qmax was defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL/sec||Standard Deviation|Mean
2757171|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores|Self-reported EF. Scores range from 0 (low or no EF) to 5 (high EF) on 6 questions (1-5, 15 of the IIEF). EF Domain scores range from 0 to 30. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. Measures were taken only for those subjects who reported they were sexually active and reported erectile dysfunction. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
2757172|NCT00827242|Secondary|Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 Weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.|||Units on a Scale||Standard Error|Least Squares Mean
2757173|NCT00827242|Secondary|Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 1 week|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1.|||Units on a Scale||Standard Error|Least Squares Mean
2757174|NCT00827242|Secondary|Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|12 weeks|All values are based on the number of subjects in the analysis population with non-missing data.|||Participants|||Number
2757835|NCT00821886|Secondary|Number of Subjects With Adverse Events as a Measure of Safety and Toxicity|Assessment based on the frequency of treatment-related adverse events according to NCI CTCAE criteria v3.0.|Day 1 of each 3 week cycle up to 6 cycles , and every 9 weeks post-surgery until treatment discontinuation|Includes eligible patients|||participants|||Number
2757175|NCT00827242|Secondary|Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data.|||Participants|||Number
2757176|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
2757177|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question|Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
2757178|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
2757179|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
2757180|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 12. For the 12 week analysis, the LOCF imputation technique was used.|||Units on a Scale||Standard Error|Least Squares Mean
2757181|NCT00827242|Secondary|Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.|||Units on a Scale||Standard Error|Least Squares Mean
2757182|NCT00827242|Primary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all subjects who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline visit. The Last Observation Carried Forward (LOCF) imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
2757183|NCT00827112|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay|Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.|Baseline to Week 96 or Time of treatment Failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Participants|||Number
2757200|NCT00827099|Secondary|Number of Patients Who Experience Disease Relapse Post-transplant|Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.|Day 100, 6 months, 1 year, 18 months, 24 months|This study was terminated early. No participants were analyzed.|||participants|||Number
2757184|NCT00827112|Secondary|Number of Participants With Phenotypic Resistance|Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Participants|||Number
2757185|NCT00827112|Secondary|Number of Participants With Genotypic Resistance|Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Participants|||Number
2757186|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||cells/mcL||Standard Deviation|Mean
2757187|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||cells/microliter (cells/mcL)||Standard Deviation|Mean
2757188|NCT00827112|Secondary|Time-Averaged Difference (TAD) in log10 Viral Load|TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).|Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.|||log10 copies/mL||Standard Error|Mean
2757189|NCT00827112|Secondary|Time to Loss of Virological Response (TLOVR)|TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.|Baseline through Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Days||Standard Error|Mean
2757190|NCT00827112|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||Percentage of participants||95% Confidence Interval|Number
2757191|NCT00827112|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||Percentage of participants||95% Confidence Interval|Number
2757192|NCT00827112|Secondary|Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||log10 copies/ml||Standard Deviation|Mean
2757193|NCT00827112|Secondary|Average Observed Plasma Concentration (Cavg) of Maraviroc|Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).|Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.|||ng/mL||Standard Deviation|Mean
2757194|NCT00827112|Secondary|Minimum Observed Plasma Concentration (Cmin) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.|||ng/mL||Full Range|Median
2757195|NCT00827112|Secondary|Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.|||nanogram (ng)/mL||Full Range|Median
2757196|NCT00827112|Secondary|Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14|Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.|Baseline , Days 4, 7, 10 and 14|First 15 participants who were enrolled at U.S sites and had taken the study drug .|||copies/mL||Standard Deviation|Mean
2757197|NCT00827112|Secondary|HIV-1 RNA Levels at Baseline||Baseline|FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.|||copies/mL||Standard Deviation|Mean
2757198|NCT00827112|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)||Week 48|Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.|||Percentage of participants||95% Confidence Interval|Number
2757199|NCT00827099|Secondary|Number of Patients Who Survive Following Treatment on This Protocol|Patients will be followed until death|Through Death|This study was terminated early. No participants were analyzed.|||participants|||Number
2757201|NCT00827099|Secondary|Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.|Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic.|Day 30|This study was terminated early. No participants were analyzed.|||participants|||Number
2757202|NCT00827099|Secondary|Percentage of Donor and Host Chimerism of Each Cord Blood Unit|Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.|day 30, day 60, day 90|This study was terminated early. No participants were analyzed.|||percentage of chimerism|||Number
2757203|NCT00827099|Secondary|Number of Patients That Engrafted Blood Counts by 30 Days After Transplant|Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant|Day 30||||participants|||Number
2757204|NCT00827099|Primary|Number of Participants With 100 Day Transplant-related Mortality (TRM)|100 Day TRM is death within 100 days from transplant related complications|100 days||||participants|||Number
2757205|NCT00827073|Primary|Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs||(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)||||bacterial spceies||Standard Deviation|Mean
2757206|NCT00827073|Primary|Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs|Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.|(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)||||Ln(bacterial colony count)||Standard Deviation|Mean
2757207|NCT00826943|Primary|Likert Score Rating Global Sedation|"Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.~This was mean data for all interventions."|duration of study (36 days)|per protocol|||Likert score||Standard Deviation|Mean
2757208|NCT00826943|Primary|Modified Epworth Sleepiness Scale|"Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.~This was mean data for all interventions."|36 days of the study|per protocol|||units on a scale||Standard Deviation|Mean
2757209|NCT00826943|Secondary|Total Four Symptom Scores (Allergy Symptoms)|"Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.~This was mean data for all interventions."|same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)||||TFSS scores||Standard Deviation|Mean
2757210|NCT00826800|Primary|To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant.||3 years||||participants|||Number
2757211|NCT00826748|Primary|Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14|The primary study endpoint is a change in the gene expression in the airway epithelium or alveolar macrophages of healthy smokers following treatment with beclomethasone. Airway epithelium and alveolar macrophages are processed to yield high quality RNA. Complementary DNA (cDNA) is transcribed from the RNA in vitro and the product is hybridized onto gene microarray chips. The chip is then scanned and the image analyzed using the Affymetrix Microarray suite version 5 (MAS5) algorithm. Using GeneSpring software the data is normalized and differential expression is determined by fold change (up or down regulation) of the individual genes by comparing the geometric mean expression value from the airway epithelium and alveolar macrophages obtained from Day 7 and Day 14 following initiation of therapy to baseline values.|Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment.|Subjects underwent bronchoscopy procedure at 7 and 14 days after baseline to collect samples including small airway epithelium and alveolar macrophages.|||Participants|||Count of Participants
2757212|NCT00826618|Secondary|The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24.||2 years|||||||
2757213|NCT00826618|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test.||1 year|||||||
2757214|NCT00826618|Secondary|The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months.||1 year|||||||
2757215|NCT00826618|Secondary|The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test.||1 year|||||||
2757216|NCT00826618|Primary|Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.|Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).|1 year||||Change in ETDRS Letters||Standard Deviation|Mean
2757217|NCT00826540|Secondary|Feasibility of Study Treatment|Will be evaluated based on the number of patients who are able to > tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.|Up to 2 years|||||||
2757218|NCT00826540|Secondary|Overall Survival|The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Time from registration to death, assessed up to 2 years|||||||
2757219|NCT00826540|Secondary|Response Rate|Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers. Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.|Up to 2 years|||||||
2757230|NCT00826280|Primary|Change in Number of Reversible Defects|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.~Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans.~The number of participants per arm is consistent for all categories of the data table."|||Reversible Defects||Standard Deviation|Mean
2757220|NCT00826540|Primary|Progression-free Survival Rate|"The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.~Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|At 3 months||||percentage of participants||95% Confidence Interval|Number
2757221|NCT00826449|Secondary|Phase II: Progression-Free Survival (PFS) Rate|A modified Thall, Simon, and Estey (1995) design used in the phase II study to monitor the proportion of patients with NSCLC who are alive and progression free (PFS) at twelve weeks after commencing treatment with dasatinib and erlotinib.|12 Weeks|Of the 35 participants in the Phase II portion of the study, one participant received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.|||Percentage of Participants|||Number
2757222|NCT00826449|Secondary|Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Patients who have a partial or complete response or stable disease are defined as progression free. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.|12 Weeks|One participant only received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.|||participants|||Number
2757223|NCT00826449|Primary|Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride|MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose-limiting toxicity (DLT) defined using NCI Common Terminology Common Terminology Criteria for Adverse Events (CTCAE) version 3 as: grade 3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT.|Baseline and at Day 21||||mg/day|||Number
2757224|NCT00826280|Secondary|Change From Baseline in Diastolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||mmHg||Full Range|Median
2757225|NCT00826280|Secondary|Change From Baseline in Systolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||mmHg||Full Range|Median
2757226|NCT00826280|Secondary|Change From Baseline in Heart Rate|"Baseline is the last non-missing measurement on or before first dose of regadenoson~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||Beats per minute||Full Range|Median
2757227|NCT00826280|Secondary|Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).~Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).~The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||Summed Difference Score||Standard Deviation|Mean
2757228|NCT00826280|Secondary|Change in Number of Reversible Defects Assessed by Computerized Quantitation|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.~Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||Reversible Defects||Standard Deviation|Mean
2757229|NCT00826280|Secondary|Change in Summed Difference Score (SDS) Across All 17 Segments|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).~Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).~The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans.~The number of participants per arm is consistent for all categories of the data table."|||Sum Difference Score||Standard Deviation|Mean
2757231|NCT00826267|Secondary|Changes in Biomarker in Tumour Biopsies|Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.|Screening, day 22, day 43|TS. The small number of available biomarker samples in this study did not allow for a meaningful statistical analysis.||||||
2757232|NCT00826267|Secondary|Plasma Concentration of Afatinib|Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2757233|NCT00826267|Secondary|Change From Baseline in the Diameter of the Primary Target Lesion.|Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.|3 weeks or 6 weeks|TS|||millimeters||Standard Error|Least Squares Mean
2757234|NCT00826267|Secondary|Number of Participants Who Achieved Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|Tumour assessments were performed at screening, day 22 and day 43.|TS|||Participants|||Number
2757235|NCT00826267|Primary|Objective Response (OR)|Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, day 22 and day 43.|Treated set (TS). TS consisted of all patients who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2757236|NCT00826241|Secondary|Number of Participants With Serious and Non-Serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 111 months and 26 days|8 patients were not evaluable/replaced: 2 - withdrew,1 - non-compliant, 2 - screen failures, 1 - could not obtain records, 1 - opted not to proceed with treatment, and 1 - unable to proceed to registration.|||Participants|||Count of Participants
2757237|NCT00826241|Secondary|Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria|Anti-tumor activity as determined by the overall response (Complete response (CR) or partial response (PR)) was assessed by the MacDonald criteria. Complete response is complete resolution of all lesions. The patient cannot be on any corticosteroids with the exception of adrenal replacement doses. Partial response is ≥50% reduction in the sum of products of all measurable lesions over baseline sum observed using the same techniques as baseline. The patient must be on a stable or decreased dose of corticosteroids to be evaluable for response.|4 weeks|8 patients were not evaluable/replaced: 2 - withdrew,1 - non-compliant, 2 - screen failures, 1 - could not obtain records, 1 - opted not to proceed with treatment, and 1 - unable to proceed to registration.|||Participants|||Count of Participants
2757238|NCT00826241|Primary|Time to Progression|Time to progression defined as progressive disease, toxicity at a level of severity that precludes the patient continuing on the protocol, or death. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|Assessed every two months till disease progression, up to 4 years|8 patients were not evaluable/replaced: 2 - withdrew,1 - non-compliant, 2 - screen failures, 1 - could not obtain records, 1 - opted not to proceed with treatment, and 1 - unable to proceed to registration.|||Months||95% Confidence Interval|Median
2757239|NCT00826228|Secondary|P1NP|amino-terminal propeptide of type I collagen (P1NP)|Baseline to 6 months|Only 8 of the total 12 participants enrolled had serum available for testing|||% change from baseline||Standard Deviation|Mean
2757240|NCT00826228|Primary|BMD at Left Total Hip|Bone mineral density (gm/cm2) of the total hip region of interest on the left|Baseline to 6 months||||% change in BMD (gm/cm2) from baseline||Standard Deviation|Mean
2757241|NCT00826202|Secondary|Pittsburgh Sleep Quality Index Score|The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and five questions rated by the bed partner or roommate. The latter five questions are used for clinical information only, are not tabulated in the scoring of the PSQI. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores|16 weeks|Completers at NYSPI and NKI sites|||final score||Standard Deviation|Mean
2757242|NCT00826202|Primary|Scale of Prodromal Symptoms (SOPS) Negative Scale|The SOPS Negative symptom scale consists of six Negative Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 36.|16 weeks||||SOPS negative final score||Standard Deviation|Mean
2757243|NCT00826202|Secondary|IL6 Levels|Final IL6 levels (pg/ml) in available subjects|16 weeks||||final IL6 level (pg/ml))||Standard Deviation|Mean
2757244|NCT00826202|Secondary|Scale of Prodromal Symptoms (SOPS) Total|The SOPS Total consists of five Positive Symptom items, six Negative Symptom items, four Disorganization Symptom items, and four General Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme—and Psychotic, for the positive items). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 114.|16 weeks||||units on a scale||Standard Deviation|Mean
2757255|NCT00826150|Secondary|Overall Survival in ITT Population|Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.|17.5 months|Intent to Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.|||Months||Full Range|Median
2757245|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.|||minutes||95% Confidence Interval|Geometric Mean
2757246|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.|||minutes||95% Confidence Interval|Geometric Mean
2757247|NCT00826176|Primary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary."|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.|||minutes||95% Confidence Interval|Geometric Mean
2757248|NCT00826150|Secondary|Overall Survival in PP|Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.|17.5 months|Per Protocol data set (PP): 11 subjects who met the study inclusion and exclusion criteria, received at least one course of treatment of the investigational product and had a follow-up disease assessment comprised the PP set (5 subjects from the 60 mg cohort, 3 subjects from the 120 mg cohort; 3 subjects from the 240 mg cohort).|||months||Full Range|Median
2757249|NCT00826150|Secondary|Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUCinf|Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.|Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion|Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.|||copies*hr/μl||Standard Deviation|Mean
2757250|NCT00826150|Secondary|Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUClast|Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.|Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion|Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.|||copies*hr/μl||Standard Deviation|Mean
2757251|NCT00826150|Secondary|Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)|Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.|Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion|Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.|||hours||Standard Deviation|Mean
2757252|NCT00826150|Secondary|Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)|Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.|Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion|Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.|||copies/μL||Standard Deviation|Mean
2757253|NCT00826150|Secondary|Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)|Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.|Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion|Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT.|||hours||Standard Deviation|Mean
2757254|NCT00826150|Secondary|Solid Tumor Response|"If measurable disease was present, then the response of each marker lesion was evaluated separately and rated for response according to RECIST criteria for solid tumors.~Complete Response: Disappearance of the target lesion. Partial Response: At least a 30% decrease in the longest diameter of the target lesion.~Stable Disease: No sufficient shrinkage to qualify for partial response, or sufficient increase to qualify for progressive disease.~Progressive Disease: At least a 20% increase in the longest diameter of the target lesion."|6 weeks|Intent To Treat (ITT) data set: subjects who participated in the study were included in the safety and in the ITT analysis. All 14 subjects who participated in the study were included in the ITT. 13 patients of the ITT population (n=14) were evaluated (one patient was not assessed for solid tumor response in the BC-819 60 mg IP Arm).|||Participants|||Count of Participants
2757289|NCT00825786|Secondary|Time to Complete Motor Block||during surgery from induction time to end case time||||minutes||Inter-Quartile Range|Median
2757256|NCT00826150|Primary|Number of Participants With Dose-Limiting Toxicities|A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.|8 weeks|Per Protocol data set (PP): 11 subjects who met the study inclusion and exclusion criteria, received at least one course of treatment of the investigational product and had a follow-up disease assessment comprised the PP set (5 subjects from the 60 mg cohort, 3 subjects from the 120 mg cohort; 3 subjects from the 240 mg cohort).|||Participants|||Count of Participants
2757257|NCT00826111|Secondary|Change in Insomnia Severity Index Score From Baseline to Week 10|The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress.|baseline and 10 weeks||||scores on a scale||Standard Deviation|Mean
2757258|NCT00826111|Secondary|Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10|The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study.|baseline and 10 weeks|Participants who completed 10 weeks and one participant who completed 6 weeks (using last observation carried forward) were included in this analysis.|||scores on a scale||Standard Deviation|Mean
2757259|NCT00826111|Secondary|Change in Hamilton Depression Rating Scale Score From Baseline to Week 10|The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms.|baseline and 10 weeks||||scores on a scale||Standard Deviation|Mean
2757260|NCT00826111|Secondary|Change in Thalamic GABA From Baseline to Week 1|GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (GABA to creatine)||Standard Deviation|Mean
2757261|NCT00826111|Secondary|Change in Anterior Cingulate Cortex GABA From Baseline to Week 1|GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (GABA to creatine)||Standard Deviation|Mean
2757262|NCT00826111|Secondary|Change in Thalamic Glutamate From Baseline to Week 1|Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (glutamate to creatine)||Standard Deviation|Mean
2757263|NCT00826111|Secondary|Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1|Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (glutamate to creatine)||Standard Deviation|Mean
2757264|NCT00826111|Primary|Change in Thalamic Glutamine From Baseline to Week 1|Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants were included in the analysis if they had usable spectroscopy data from baseline and week 1 and were not considered to have any confounding issues such as an abnormal structural MRI.|||ratio (glutamine to creatine)||Standard Deviation|Mean
2757265|NCT00826111|Primary|Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.|Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants who had usable MRS data from both the baseline and week 1 scans were included in the analysis. Participants whose data was considered unreliable were excluded.|||ratio (glutamine to creatine)||Standard Deviation|Mean
2757266|NCT00826020|Secondary|Number of Subjects With Reversal of Biochemical Cholestasis|Of patients starting with elevated total serum bilirubin, the number that progress to normalization of serum total bilirubin in routine bloodwork|weekly x 4, then bi-weekly x4, then monthly until the completion of the study, with an average follow-up of 5.5 years for the study cohort||||Participants|||Count of Participants
2757267|NCT00826020|Primary|Number of Patients With Progression to Small Bowel Transplantation.|Whether or not the subject had an intestine-containing transplant or not|Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort||||Participants|||Count of Participants
2757268|NCT00826007|Primary|Hypoglycemia Incidence|Blood glucose values <70 mg/dl|perioperative period||||participants|||Number
2757269|NCT00825994|Secondary|Change in Hot Flash Daily Interference Scale (HFRDIS)|Vasomotor symptoms (hot flashes) were tracked by using a self-report Hot Flash Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study. Of these 20, 15 women had hot flashes at baseline and could be included in the hot flash analysis.|||units on a scale||Standard Deviation|Mean
2757290|NCT00825786|Primary|Duration of Analgesia.|The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.|During surgery: postoperative day 0||||minute||Inter-Quartile Range|Median
2757270|NCT00825994|Primary|Change in MADRS Score|"The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS).~The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden)."|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study.|||units on a scale||Standard Deviation|Mean
2757271|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume, and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the smooth interpolated skin surface, and was always a negative number. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters cubed||Standard Deviation|Mean
2757272|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included scar measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface and was always a negative number. A more negative number was worse because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
2757273|NCT00825916|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 millimeters (mm), with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in longitudinal (chronological) order. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 for each of the two raters separately. Data from the two raters was not combined.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
2757274|NCT00825916|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 3 mg AZX100, and 10 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 3 mg and 10 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Units on a scale||Standard Deviation|Mean
2757275|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left primary visual cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757276|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757291|NCT00825734|Secondary|Number of Patients With Adverse Events as a Measure of of Safety and Tolerability|Assessments are made through analysis of reported incidence of treatment-emergent AEs and SAEs.|every 9 weeks until treatment discontinuation or unacceptable toxicity|Patients treated at the Phase II dose|||participants|||Number
2757292|NCT00825734|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose|||months||95% Confidence Interval|Median
2757277|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757278|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757279|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757280|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.|Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right insular cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757281|NCT00825825|Primary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.|Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus.|two weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
2757282|NCT00825812|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|The Full Analysis Set population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.|||minutes||95% Confidence Interval|Geometric Mean
2757283|NCT00825812|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary."|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|"The Full Analysis Set (FAS) population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.~291 subjects received IMP, of whom two had no efficacy measurements at all. Hence the FAS consisted of 289 subjects."|||minutes||95% Confidence Interval|Geometric Mean
2757284|NCT00825786|Secondary|Total Opioid Consumption|In morphine equivalent dose|postoperative day 1 to day 3||||mg||Inter-Quartile Range|Median
2757285|NCT00825786|Secondary|Duration of Analgesia|Time from the complete onset of sensory block until first request for an analgesic|from surgery date to postoperative day 1||||hours||Inter-Quartile Range|Median
2757286|NCT00825786|Secondary|Maximum Verbal Response Score (VRS) With Movement|The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst|through post operative day 3||||mm||Inter-Quartile Range|Median
2757287|NCT00825786|Secondary|Maximum Verbal Response Score (VRS) With Rest|The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain|through post operative day 3||||mm||Inter-Quartile Range|Median
2757288|NCT00825786|Secondary|Time to Onset of First Sensory Block||during surgery||||minutes||Inter-Quartile Range|Median
2757294|NCT00825734|Secondary|6-month Progression-Free Survival|Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks, up to 6 months|Includes patients treated at the Phase II dose|||percentage of participants|||Number
2757295|NCT00825734|Primary|Progression-Free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose|||months||95% Confidence Interval|Median
2757296|NCT00825682|Secondary|The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)|"examines several aspects of sleep disorders and includes 21 items that describe feelings and behaviors associated with sleep during the last week. It uses a 0 (never) to 7 (every day) Likert scale on questions like feeling nervous during the day; falling asleep while unplanned and using sleeping pills.~A total sleep disturbance score was calculated as the average of all 21 items (ranging between 0 and 7), higher scores indicating a worse outcome."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 34 women in the experimental group and 20 in the control group.|||Scores on a scale||Standard Deviation|Mean
2757297|NCT00825682|Secondary|The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).|"The questionnaire includes 33 items describing different forms in which the disease may affect patient's quality of life. For each item, subjects are asked to mark the number that best describes their feelings right now, in a Likert scale ranging between 0 and 10. Items include happiness feelings, anxiety levels, how affected are the social ties because of the disease, etc.~A total quality of life score was calculated as the average of all 33 items (ranging between 0 and 10), higher scores indicating a better quality of life."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final ananlysis included 34 women in the experimental group, and 20 women in the control group.|||Scores on a scale||Standard Deviation|Mean
2757298|NCT00825682|Primary|The Lee Fatigue Scale|"The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue.~The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 33 women in the experimental group and 20 in the control group.|||units on a scale||Standard Deviation|Mean
2757299|NCT00825630|Primary|Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.|Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.|17 days|Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study.|||participants|||Number
2757300|NCT00825565|Primary|Physician Assessment of Individual Signs|"In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated.~This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe"|baseline and at 12 weeks|Subjects who used cream on entire body for the entire month was used in the analysis.|||Participants|||Count of Participants
2757301|NCT00825565|Primary|Physician Global Assessment of Severity (PGAS)|"The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a global impression.~This scale produced a score with the following correlations:~0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)"|baseline and then every 4 weeks for a total of 12 weeks|One subject discontinued after week 3. One subject discontinued at Month 2. Only data presented for subjects who used cream on entire body for the entire month was used in the analysis.|||Participants|||Count of Participants
2757318|NCT00825266|Secondary|NYHA (New York Heart Association Classification) Changes|"New York Heart Classification(NYHA) changes measured at 16 weeks compared with baseline.~NYHA Classification:~NYHA class I:no symptoms and no limitation in ordinary physical activity NYHA class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity, NYHA class IV:Severe limitations. Experiences symptoms even while at rest. {Higher NYHA class represent worse symptoms}"|Baseline and 16 weeks||||NYHA class|||Number
2757319|NCT00825266|Secondary|6 Minute Walk Test|6 minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.It assess the disease severity of the subject at 16 week compared to the baseline.|Baseline and 16 weeks||||meters|||Number
2757302|NCT00825565|Primary|Target Wound Size Reduction or Closure|"EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream.~Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis.|||number of unhealed target wounds|||Number
2757303|NCT00825565|Primary|Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage|"A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease spread with weighting factors."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis.|||percentage of BSA involvement||Standard Deviation|Mean
2757304|NCT00825500|Secondary|Photophobia Free|Free of Photophobia at 2 Hours Post-treatment|2 hours|ITT with LOCF Population|||Participants|||Count of Participants
2757305|NCT00825500|Primary|Pain-Relief at 2 Hours Post-treatment|Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time|2 hours|ITT with LOCF Population|||Participants|||Count of Participants
2757306|NCT00825370|Secondary|Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).|"Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The averages were calculated by finding the mean of change in pain intensity for each patient."|Up to 60 minutes||||units on a scale||Standard Deviation|Mean
2757307|NCT00825370|Secondary|Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes|"Patients who did not want pain medication determined by those who answered no to the question do you want more pain medication? at 60 minutes after treatment."|60 minutes||||percentage of participants|||Number
2757308|NCT00825370|Secondary|Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes|"As defined by the percentage of patients who answer no to the question, Do you want more pain medication? at 15 minutes"|15 min||||Percentage of Participants|||Number
2757309|NCT00825370|Primary|Percentage of Patients With Successful Treatment|Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients included in analysis is due to missing data (6 from Protocolized and 4 from Discretionary Care) and participants enrolled more than once (2 from Protocolized).|||Percentage of Participants|||Number
2757310|NCT00825344|Secondary|Chronic Post-surgical Pain|Patients with persistent post-surgical pain|Up to 12 months||||participants|||Number
2757311|NCT00825344|Secondary|Analgesic Usage|Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery|24 hours||||tablets||Standard Deviation|Mean
2757312|NCT00825344|Primary|Numerical Rating Scale Pain Score|0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period.|24 hours||||units on a scale||Standard Deviation|Mean
2757313|NCT00825318|Primary|Mean Arterial Blood Pressure||Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)||||mm Hg||Full Range|Mean
2757314|NCT00825305|Secondary|Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.|Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.|7 days, 14 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.|||percentages of participants||95% Confidence Interval|Mean
2757315|NCT00825305|Primary|Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination|Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.|7 days after each vaccination|Safety was analyzed for the safety set. One enrolled subject was not vaccinated and not included in the safety set because of inappropriate inclusion.|||participants|||Number
2757316|NCT00825305|Secondary|Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.|Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|7 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.|||IU/ml||95% Confidence Interval|Log Mean
2757317|NCT00825305|Primary|Rabies Virus Neutralizing Antibody Concentrations on Day 14.|Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|14 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.|||IU/mL||95% Confidence Interval|Log Mean
2757320|NCT00825266|Primary|Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio|insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.|baseline and 16 weeks||||ratio|||Number
2757321|NCT00825227|Secondary|Change in the Brief Fatigue Inventory (BFI) Global Score|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)|This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.||||||
2757322|NCT00825227|Secondary|Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)|This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.||||||
2757323|NCT00825227|Primary|Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire|Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.|Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)|Study was discontinued after only 6 subjects were enrolled due to a business decision, so no outcome analysis was done.||||||
2757324|NCT00825175|Primary|Pattern of Gross Motor Development|Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.|monthly; starting when child can pull to stand and ending when the test determined that the child was walking.|analysis was on protocol|||months||Standard Deviation|Mean
2757325|NCT00825162|Secondary|Frequency of New Onsets of Chronic Illness||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.|||Participants|||Number
2757326|NCT00825162|Secondary|Frequency of Serious Adverse Events||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.|||Participants|||Number
2757327|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Days||Standard Deviation|Mean
2757328|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Participants|||Number
2757329|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Days||Standard Deviation|Mean
2757330|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Participants|||Number
2757331|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Days||Standard Deviation|Mean
2757332|NCT00825162|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Event.|30 days after each study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.|||Participants|||Number
2757333|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Participants|||Number
2757334|NCT00824993|Primary|Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months|The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.|Baseline to 6 months and Baseline to 12 months|We analyzed changes in BMD from baseline only for those who had follow up BMD evaluated at 6 and 12 months|||Percentage change||Standard Deviation|Mean
2757335|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
2757336|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
2757337|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination|Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), >39 but ≤40 degrees C (moderate), or >40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).|Baseline up to 4 days after vaccination on Day 1|Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).|||percentage of participants|||Number
2757338|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination|Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (> 7.0 cm). Participants may be represented in >1 category.|Baseline up to 4 days after vaccination on Day 1|Safety population included all participants who received the vaccine. N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).|||percentage of participants|||Number
2757339|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.|||Titer||95% Confidence Interval|Geometric Mean
2757340|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.|||Titer||95% Confidence Interval|Geometric Mean
2757341|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.|||Mcg/mL||95% Confidence Interval|Geometric Mean
2761506|NCT00795951|Primary|Diagnostic Performance: Quinoline Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2757342|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.|||Mcg/mL||95% Confidence Interval|Geometric Mean
2757343|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Titer||95% Confidence Interval|Geometric Mean
2757344|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Titer||95% Confidence Interval|Geometric Mean
2757345|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Titer||95% Confidence Interval|Geometric Mean
2757346|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Titer||95% Confidence Interval|Geometric Mean
2757347|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Mcg/mL||95% Confidence Interval|Geometric Mean
2757348|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Mcg/mL||95% Confidence Interval|Geometric Mean
2757349|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Mcg/mL||95% Confidence Interval|Geometric Mean
2757362|NCT00824733|Secondary|Progression-free Survival for Patients With Metastatic Breast Cancer That Are Receiving Trastuzumab Plus PF-03512676|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 18 weeks||||weeks||Full Range|Median
2757350|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Mcg/mL||95% Confidence Interval|Geometric Mean
2757351|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
2757352|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
2757353|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
2757354|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.|Day 28 (Visit 5)|Evaluable Immunogenicity population: eligible participants based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.|||observed percentage of participants||95% Confidence Interval|Number
2757355|NCT00824824|Primary|Presence of Retinal Vascular Dysregulation (RVD)|We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.|6 weeks post treatment|21 participants were tested for RVD after 6 weeks of timolol treatment. Of the 21 participants who were tested, 7 had RVD and were randomized to Dorzolamide-Timolol and Brimonidine-Timolol; 14 had normal autoregulation. One participant was removed from the analysis in the Brimonidine-Timolol arm due to technical difficulties with equipment.|||Participants|||Number
2757356|NCT00824772|Secondary|Postoperative Cumulative Fentanyl Consumption||48hr after surgery||||mcg||Standard Deviation|Mean
2757357|NCT00824772|Primary|Postoperative Cumulative Fentanyl Consumption||24 hr after surgery||||mcg||Standard Deviation|Mean
2757358|NCT00824746|Secondary|Overall Survival||2 years||||days||95% Confidence Interval|Median
2757359|NCT00824746|Primary|Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT|Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).|8 weeks|we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).|||percentage of participant with DC||95% Confidence Interval|Number
2757360|NCT00824746|Secondary|Progression - Free Survival of Patients Retreated With Gefitinib|Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.|two year||||days||95% Confidence Interval|Median
2757361|NCT00824733|Secondary|Combination of PF-03512676 and Trastuzumab Induces MIP-1 (Macrophage Inflammatory Protein 1), MCP-1 (Monocyte Chemoattract Protein 1) and RANTES.||up to 18 weeks|The study was terminated early due to poor patient accrual and no data was collected and analyzed.||||||
2757364|NCT00824720|Primary|Visual Acuity - Left Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days||||logMARs||Standard Deviation|Mean
2757365|NCT00824720|Primary|Visual Acuity - Right Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days||||logMAR units||Standard Deviation|Mean
2757366|NCT00824720|Secondary|Intraocular Pressure (IOP)||from baseline to 14 days|The analysis population includes all subjects with a plug insertion that completed the study per protocol.|||mmHg||Standard Deviation|Mean
2757367|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
2757368|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
2757369|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
2757370|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
2757371|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.|12 months of age (prior to toddler dose)|Evaluable Toddler Immunogenicity Population|||mcg/mL||95% Confidence Interval|Geometric Mean
2757372|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population|||mcg/mL||95% Confidence Interval|Geometric Mean
2757373|NCT00824655|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2757374|NCT00824655|Primary|Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2757375|NCT00824616|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.|From first dose of study drug (Week 0) to last dose of study drug (Week 20)|All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).|||participants|||Number
2757376|NCT00824616|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) Level|HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.|Baseline (Day 1) and End of Treatment (Week 20)|Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.|||% HbA1c||95% Confidence Interval|Least Squares Mean
2757377|NCT00824564|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 5 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||Participants||95% Confidence Interval|Number
2757378|NCT00824564|Secondary|Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery||Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||gram/deciliter (g/dl)||Standard Deviation|Mean
2757379|NCT00824564|Secondary|Number of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent.|Up to day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||Participants||95% Confidence Interval|Number
2757380|NCT00824564|Secondary|Total Blood Loss Assessed by Gross' Formula|Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||mL||Standard Deviation|Mean
2757381|NCT00824564|Secondary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|1, 4, 8 and 24 hours post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||mL||Standard Deviation|Mean
2757382|NCT00824564|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||mL||Standard Deviation|Mean
2757383|NCT00824564|Primary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 7 post-surgery|Full analysis set (FAS) included all participants who were randomized to study treatment and received at least one dose of study medication.|||Milliliters (mL)||Standard Deviation|Mean
2757384|NCT00824538|Secondary|Effect of Sunitinib Malate on OTC in Peripheral Blood|Data was not collected due to emerging data on toxicity and competing trials.|After one year of treatment|||||||
2757385|NCT00824538|Secondary|Relapse-free and Overall Survival|Data was not collected due to emerging data on toxicity and competing trials.|up to 3 years from beginning of treatment|||||||
2757386|NCT00824538|Secondary|Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0||up to 7 months after start of treatment||||participants|||Number
2757387|NCT00824538|Secondary|Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study||after 6 months from start of treatment||||participants|||Number
2757388|NCT00824538|Primary|Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow|DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL|Baseline, 6 months after start of treatment||||percentage of change||Full Range|Mean
2757389|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Investigator|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mm||Full Range|Median
2757390|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Parents|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mm||Full Range|Median
2757391|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Patient|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mm||Full Range|Median
2757491|NCT00824291|Secondary|Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
2757392|NCT00824512|Secondary|Choice Reaction Time Test- Movement Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||millisecond||Full Range|Median
2757393|NCT00824512|Secondary|Choice Reaction Time Test- Reaction Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||millisecond||Full Range|Median
2757394|NCT00824512|Secondary|Nine Hole Peg Test (Nondominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
2757395|NCT00824512|Secondary|Nine Hole Peg Test (Dominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
2757396|NCT00824512|Secondary|Timed 25-foot Walk Test||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
2757397|NCT00824512|Secondary|ICARS (Oculomotor Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Oculomotor Disorders. Oculomotor Disorders score range from 0 to 6 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
2757398|NCT00824512|Secondary|ICARS (Speech Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Speech Disorders. Speech Disorders Score range from 0 to 8 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
2757399|NCT00824512|Secondary|ICARS (Kinetic Function Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Kinetic Function. Kinetic Function score range from 0 to 52 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
2757400|NCT00824512|Secondary|ICARS (Posture and Gait Disturbance Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Posture and gait disturbances. Posture and gait disturbances score range from 0 to 34 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
2757401|NCT00824512|Secondary|International Cooperative Ataxia Rating Scale [ICARS] (Total Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales (i.e. Posture and gait disturbances, Kinetic functions, Speech disorders, & Oculomotor disorders). Scores for each subscale quantify the extent of ataxia in each clinically important area and subscale scores are also summed to give a total score ranging from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
2757492|NCT00824291|Secondary|Change From Baseline on Work and Activities Item of HAM-D17 at Week 12|The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
2757402|NCT00824512|Secondary|Metabolism Efficacy Index|The metabolism efficacy index was derived as Normalised work x creatine phosphorylation rate (sec-1). [Normalised work was derived as Work developed during the exercise/(60 X Maximum cross section of muscle-1100)]. Greater values of Metabolism Efficacy index indicate improvement in skeletal muscle energetics while lower values indicate the reverse. Negative values obtained using the formula indicated severe levels of muscle weakness.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||per second||Full Range|Median
2757403|NCT00824512|Secondary|Normalised Work Developed During the Exercise|"Normalised work developed during the exercise was derived as Work developed during the exercise/([60 X Maximum cross section of muscle]-1100).~Normalised work measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy."|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||Joules/cm^2||Full Range|Median
2757404|NCT00824512|Secondary|Developed Force During the Exercise Bout|Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||Joules||Full Range|Median
2757405|NCT00824512|Secondary|Muscle Trophicity: Maximum Cross Section of Muscle|Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm^2)|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||cm^2||Full Range|Median
2757406|NCT00824512|Secondary|Muscle Reoxygenation Rate Post Exercise.|Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||per second||Full Range|Median
2757407|NCT00824512|Secondary|Perfusion-time Integral During the First 9 Minutes Post Exercise.|The integral of 'peak perfusion' over a period of 9 minutes post exercise.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mL/100 g of tissue||Full Range|Median
2757408|NCT00824512|Secondary|Time to Peak Perfusion||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
2757409|NCT00824512|Secondary|Peak Post Exercise Perfusion|Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||ml/mn/100 g of tissue||Full Range|Median
2757410|NCT00824512|Primary|Creatine Rephosphorylation Rate Post Exercise|Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||pH per second||Full Range|Median
2757411|NCT00824473|Secondary|Change From Baseline on Direct Visual Nasal Exams to 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion,Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days||||Participants|||Number
2757412|NCT00824473|Secondary|Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Scores for a series of subsclaes are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|14 Days||||Units on a Scale||Standard Deviation|Least Squares Mean
2757413|NCT00824473|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible TOSS score is 9 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to14 Days||||Scores on a scale||Standard Deviation|Least Squares Mean
2757836|NCT00821886|Primary|Pathologic Complete Response (pCR)|Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery|average18 months|Patients who underwent surgery per protocol|||participants|||Number
2757414|NCT00824473|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to 14 Days||||scores on a scale||Standard Deviation|Least Squares Mean
2757415|NCT00824473|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline to 14 Days||||Score on a scale||Standard Deviation|Least Squares Mean
2757416|NCT00824473|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||Scores on a scale||Standard Deviation|Least Squares Mean
2757417|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 5||5 weeks after baseline|"For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5."|||mmol/L||Standard Deviation|Mean
2757418|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 4||4 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4."|||mmol/L||Standard Deviation|Mean
2757419|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 2||2 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2."|||mmol/L||Standard Deviation|Mean
2757420|NCT00824460|Primary|Change From Baseline in Serum-phosphate Levels at the End of Treatment.||6 weeks after baseline|For the Primary Outcome, data from the Full Analysis Set (FAS) was used. The FAS consists of all randomised subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).|||mmol/L||Standard Deviation|Mean
2757421|NCT00824434|Secondary|Technical Success|Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.|Acute-At time of index procedure|Intention to treat|||percentage of stents attempted|Participants||Number
2757422|NCT00824434|Secondary|Clinical Procedural Success|Mean lesion diameter stenosis < 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR|Duration of hospital stay (usually 1-2 days)|Analysis was intention to treat|||percentage of participants|||Number
2757423|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757424|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757425|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757861|NCT00821431|Primary|Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)||12 Weeks||||Number of Subjects with Adverse Events|||Number
2757426|NCT00824434|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757427|NCT00824434|Secondary|Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757428|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757429|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757430|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757431|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757432|NCT00824434|Secondary|All-cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757433|NCT00824434|Secondary|Myocardial Infarction (MI)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757434|NCT00824434|Secondary|Occurance of Post-procedure Incomplete Stent Apposition|Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound|Post-procedure|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition|||percentage of participants|||Number
2757435|NCT00824434|Secondary|In-stent Late Loss|In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)|9 months|Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.|||millimeters||Standard Deviation|Mean
2757436|NCT00824434|Primary|Cardiac Events (Composite)|Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium [ARC] definitions); see below for definitions of individual components.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757437|NCT00824421|Secondary|Plasma Concentration of Lersivirine at 24 Hour|The observed plasma concentration at 24 hours post-dose (C 24h).|24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who further consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2757438|NCT00824421|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||hr||Full Range|Median
2757439|NCT00824421|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2757862|NCT00821327|Secondary|Ovarall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population|||months||95% Confidence Interval|Median
2757440|NCT00824421|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0-24). Only participants from Lersivirine treatment arms were planned to be analyzed for Pharmacokinetic (PK) sub-study.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4|Pharmacokinetic sub-study analysis set (PKSSAS) included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2757441|NCT00824421|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, it was deemed that the interpretation of the pharmacokinetic/pharmacodynamic (PK/PD) results would be questionable, thus data was not analyzed.||||||
2757442|NCT00824421|Secondary|Population Pharmacokinetic (PK) of Lersivirine|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the participant flow and baseline characteristics modules.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48|||||||
2757443|NCT00824421|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included hematology, blood chemistry, serum and urine pregnancy test, hepatitis testing and urinalysis. Laboratory values that met the criteria of the Division of Acquired Immuno Deficiency Syndrome (DAIDS) grade 1 (mild, symptoms causing no or minimal interference with usual social and functional activities) or greater were considered as abnormal.|Baseline up to Week 96 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2757444|NCT00824421|Secondary|Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96|Phenotypic resistance and genotypic resistance was assessed for all participants at Day 1 predose, and was evaluated for nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) resistance-associated mutations at time of treatment failure using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure, up to Week 96.|Day 1 (pre-dose) through Week 24, 48, 96|Virology analysis set (TLOVR50 failures) included all participants who meet the TLOVR50 failure definition. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point for each group, respectively.|||participants|||Number
2757445|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.|||percentage of total lymphocytes||Standard Deviation|Mean
2757446|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
2757447|NCT00824421|Secondary|Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response is compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; met treatment failure [TF] criteria). TF: an increase to at least 3 times baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL). TF criteria's defined above were confirmed by second measurement at least 14 days after first. In 'TLOVR50', '50' denotes the lower limit of quantification (LLOQ) of assay (which is 50 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Missing value was imputed per the TLOVR algorithm.|||percentage of participants|||Number
2757448|NCT00824421|Secondary|Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as area under the curve of HIV-1 RNA levels (log10 copies/mL) from baseline to the time point of interest divided by time period in weeks minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline up to Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation was missing: value calculated to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.|||log10 copies/mL||Standard Deviation|Mean
2757449|NCT00824421|Secondary|Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|For the log 10 scale, all the HIV-1 RNA levels were log 10 transformed prior to the average calculations. Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: Last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.|||log 10 copies/mL||Standard Deviation|Mean
2757450|NCT00824421|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=400 copies/mL and were referred to as non-completer = failure.|||percentage of participants|||Number
2757451|NCT00824421|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.|||percentage of participants|||Number
2757452|NCT00824421|Primary|Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 48|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.|||percentage of participants|||Number
2757453|NCT00824408|Secondary|Vss of Pemetrexed|Vss - apparent volume of distribution at steady state following IV administration of pemetrexed|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data|||Litres||Geometric Coefficient of Variation|Geometric Mean
2757454|NCT00824408|Secondary|CL of Pemetrexed|CL - total clearance of pemetrexed in plasma after IV administration|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2757455|NCT00824408|Secondary|Cmax of Pemetrexed|Cmax - maximum measured concentration of pemetrexed in plasma|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2757456|NCT00824408|Secondary|Vss of Volasertib|Vss - apparent volume of distribution at steady state following IV administration of volasertib|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data|||Litres||Geometric Coefficient of Variation|Geometric Mean
2757457|NCT00824408|Secondary|Total Clearance (CL) of Volasertib|CL - total clearance of volasertib in plasma after IV administration|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2757458|NCT00824408|Secondary|Cmax of Volasertib|Cmax - maximum measured concentration of volasertib in plasma.|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|Pharmacokinetic (PK) set, which included all patients in the treated set with volasertib monotherapy or combined with pemetrexed and provided at least 1 blood sample for measurement of volasertib (BI 6727) or pemetrexed. Including patients with evaluable data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2757459|NCT00824408|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities|Frequency of patients with possible clinically significant abnormalities|From first drug infusion until 21 days after last drug infusion, up to 1100 days|On-treatment for lab|||participants|||Number
2757460|NCT00824408|Secondary|Occurence of DLT|"Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:~treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).~treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.~CTCAE Grade 4 thrombocytopenia."|Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.|Treated set, run-in phase, first course only|||participants|||Number
2757461|NCT00824408|Secondary|Occurrence and Intensity of AEs Graded According to CTCAE.|All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Treated set, which included all patients who were dispensed and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
2757462|NCT00824408|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.|From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented|Randomized phase II set|||weeks||Inter-Quartile Range|Median
2757463|NCT00824408|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration of time from randomization to time of death.|From randomization until time of death|Randomized phase II set, including only patients who died.|||months||95% Confidence Interval|Median
2757490|NCT00824291|Secondary|Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12|WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
2757464|NCT00824408|Secondary|Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.|Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Randomized set|||percentage of participants|||Number
2757465|NCT00824408|Primary|Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.|"Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.~The number of participants analysed displays the number of patients with an event (progression)."|From randomization until disease progression or death|Randomized phase II set, which included all patients who were randomized as part of phase II of the study (not the run in phase)|||months||95% Confidence Interval|Median
2757466|NCT00824382|Secondary|AUC0-1,ss|Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2757467|NCT00824382|Secondary|AUC0-1|Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2757468|NCT00824382|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)|Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2757469|NCT00824382|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2757470|NCT00824382|Secondary|Difference From Baseline in Potassium|Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.|Baseline, Week 4|Treated set.|||mmol/L||Standard Deviation|Mean
2757471|NCT00824382|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|4 weeks|Treated set.|||percentage of participants|||Number
2757472|NCT00824382|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Number of puffs||Standard Error|Mean
2757473|NCT00824382|Secondary|Weekly Mean Evening PEFR After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,~Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter/minute||Standard Error|Least Squares Mean
2757474|NCT00824382|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,~Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter/minute||Standard Error|Least Squares Mean
2757475|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.~FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|Baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757476|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.~FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757477|NCT00824382|Secondary|FVC Peak(0-3) Response|The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757478|NCT00824382|Secondary|FVC AUC(0-3) Response|"The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.~Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757479|NCT00824382|Secondary|Trough FVC Response at Week 4|The change from baseline in Trough FVC after 4 weeks of treatment|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757480|NCT00824382|Secondary|FEV1 Peak(0-3) Response at 4 Weeks|The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757481|NCT00824382|Secondary|FEV1 AUC(0-3) Response at 4 Weeks|"The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.~Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757482|NCT00824382|Secondary|Trough FEV1 Response at Week 2|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication|baseline and after 2 weeks treatment|The full analysis set (FAS) - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757483|NCT00824382|Primary|Trough FEV1 Response at Week 4|The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
2757484|NCT00824369|Secondary|CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.|||Percentage of total lymphocytes||Standard Deviation|Mean
2757485|NCT00824369|Secondary|Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.|||cells/uL||Standard Deviation|Mean
2757486|NCT00824369|Secondary|Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.|||Number of participants|||Number
2757487|NCT00824369|Secondary|Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ > 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.|||Number of participants|||Number
2757488|NCT00824369|Primary|Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events|The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.|End of Study visit or the Early Termination visit|Safety population consisted of all participants who were enrolled in this study.|||Number of participants|||Number
2757489|NCT00824291|Secondary|Change From Baseline on Stress and Social Support Scales at Week 12|Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
2758029|NCT00819390|Secondary|Percent CD8 CD38+ at Baseline|Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
2757493|NCT00824291|Secondary|Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale|||Number
2757494|NCT00824291|Secondary|Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale|||Number
2757495|NCT00824291|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12|Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
2757496|NCT00824291|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.|At Baseline and Week 12.|Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)|||Scores on a scale||Standard Error|Mean
2757497|NCT00824265|Secondary|Time of Occurrence of Cmax (Tmax) of Ofatumumab|Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4.|Cycle 1 Week 1, Cycle 1 Week 2, Cycle 4|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)|||Hour||95% Confidence Interval|Geometric Mean
2757498|NCT00824265|Secondary|Maximum Concentration (Cmax) and Observed Drug Concentration Prior to the Next Dose (Ctrough) of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab.Cmax and Ctrough were determined. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)|||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
2757499|NCT00824265|Secondary|Mean Area Under the Time-concentration Curve (AUC) Curve Over the Dosing Interval (AUC[0-tau]) of Ofatumumab|Area under the time-concentration curve (AUC) over the dosing interval (AUC[0-tau]) was evaluated. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5,6|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)|||hour*nanogram/mililiter (h*ng/mL)||95% Confidence Interval|Geometric Mean
2757500|NCT00824265|Secondary|Mean of Health Change Questionnaire (HCQ)|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.|||Unit on a scale||Standard Deviation|Mean
2757501|NCT00824265|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30, a self-reported, cancer-specific instrument assessing 15 domains: physical, role, emotional, cognitive and social functioning, pain,fatigue, nausea and vomiting, insomnia, loss of appetite, constipation, diarrhea, and dyspnea, financial difficulties and a global health status/quality of life (QOF). Functional and symptoms scales were measured on four point Likert scale where 1 = not at all and 4 = very much. Pat. assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Clinically meaningful changes or minimally important differences (MIDs)have been previously established for the EORTC QLQ C30, and categorized as 'small' if the mean change in scores is 5-10 points, 'moderate' if 10-20 points, and 'large' if >20points.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed|||Scores on a scale||Standard Deviation|Mean
2757502|NCT00824265|Secondary|Change From Baseline in Patient Reported Outcome (PRO) as Assessed by EuroQoL Five-Dimension (EQ-5D) Score at Indicated Visit|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (death) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A Negative health status describes health state worse than death.Baseline is the most recent, non-missing value prior to or on the first study drug dose date.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2757503|NCT00824265|Secondary|Changes in Patient Reported Outcome (PRO) Measures and Scores for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection scale [IS] (4 items) - and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value was obtained at randomization.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|Participants|||scores on a scale||Standard Deviation|Mean
2757504|NCT00824265|Secondary|Prognostic and Biological Markers Correlating With Clinical Response|Blood samples were collected for the assessment of the following prognostic markers at BL: immunoglobulin heavy chain variable region(IgVH) homology; Zeta-Chain-Associated Protein Kinase 70(ZAP70), VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]); beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH included 6q-,11q-, +12q, 17p-, 13q-) , ZAP-70 (positive, negative or intermediate), VH3-21 usage (Yes and No), IgVH homology (>98%, 97%-98% and <97%), beta 2 microglobulin (>3500 microgram per liter [µg/L] and <=3500 µg/L). For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=cytogenetics (CY G).|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2757505|NCT00824265|Secondary|Change From Baseline in Cell Counts, CD5- CD19+|CD5- CD19+ cells were counted by flow cytometry at Screening (baseline) at Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during treatment period and after last dose of study drug at 1 M and then every three month up to 45 M during follow up period. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. Day 1 if available otherwise screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three month up to 45 M during Follow-up Period|Safety Population|||cells/uL||Standard Deviation|Mean
2757506|NCT00824265|Secondary|Change From Baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+|CD5+ and CD19+ cells were counted by flow cytometry at Screening (Baseline) on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during the treatment period and after last dose of study drug at 1 M and then every three month follow up up to 45 M. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. day 1 if available, otherwise, screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three months up to 45 M during Follow-up Period|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||cells/uL||Standard Deviation|Mean
2757507|NCT00824265|Secondary|Mean Level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. Blood samples were collected from each participant and IgA, IgG, and IgM were measured at Baseline, and 1M and 6M after last dose during follow up period.|Baseline, 1M and 6M follow up|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Gram per liter||Standard Deviation|Mean
2757508|NCT00824265|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products or blood supportive care product are included.|From randomization up to 5 years after last dose of study drug|Safety Population|||Participants|||Number
2757509|NCT00824265|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression Adverse Events|Participants with at least one Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population|||Participants|||Number
2757510|NCT00824265|Secondary|Number of Participants With Drug Related Infections Reported as AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population|||Participants|||Number
2757511|NCT00824265|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA)|"AIHA is a condition where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants experienced AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population|||Participants|||Number
2757512|NCT00824265|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at Indicated Time Points|Serum samples for analysis of HAHA were collected at Baseline (Screening), after 3 cycles were compelted, after 1 M and 6 M post last dose. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive.|From start of study drug until 60 days after the last dose of study medication|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles)|||Participants|||Number
2757513|NCT00824265|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From first dose of study medication to 60 Days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population: Participants who received at least one dose of a study drug.|||Participants|||Number
2757514|NCT00824265|Secondary|Number of Participants Who Were Negative for MRD Assessed by Investigator|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2757515|NCT00824265|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD) Assessed by IRC|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2757516|NCT00824265|Secondary|Percentage of Participants With the Best OR, as Assessed by the Investigator|"OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.~Responder = CR + CRi + NPR + PR"|From randomization up to 5 years after last dose of study drug|ITT Population|||Percentage of participants|||Number
2757517|NCT00824265|Secondary|Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population|||Percentage of participants|||Number
2757518|NCT00824265|Secondary|Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time|Participants with no B-symptoms (B-Sy) (no night sweat, no weight loss, no fever and no extreme fatigue) and at least one indicated B-sy(night sweats, weight loss, fever or extreme fatigue) were presented at Screening, Cycle 1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and during follow up period at 1 M after study drug therapy, then every 3 M up to 5 year (up to 60 months).|Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, 3M, then every 3 M up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2757529|NCT00824070|Primary|The Aqueous Humor Drug Concentration.|An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.|Visit 2, 1-14 days following screening visit|Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.|||µg/mL|Participants|Standard Deviation|Mean
2758030|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 24 for On-ART Participants|Results reported are for HIV-1 RNA at week 24 for on-ART participants.|At week 24|Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.|||participants|||Number
2757519|NCT00824265|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. ECOG performance status are measured at Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1 and Cycle 6 Day1. During follow period, 1 M after study drug therapy, then every 3 month up to 5 year (up to 60 months). Improvement is defined as a decrease from baseline by at least one step on the ECOG performance status scale (yes/no).|Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, 3M, then every 3 month up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2757520|NCT00824265|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment. Data are presented for participants who took anti-cancer therapies and participants in the ITT population.|From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug)|ITT Population|||Months||95% Confidence Interval|Median
2757521|NCT00824265|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to PD. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after the last dose of study drug|ITT Population.|||Months||95% Confidence Interval|Median
2757522|NCT00824265|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug)|ITT Population. Par with unknown or missing responses were considered as non-responders, only responders were included in this analysis.|||Months||95% Confidence Interval|Median
2757523|NCT00824265|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response. Complete Response/remission(CR) all the criteria at least 2 months after last treatment: no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/spleenomegaly/constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. Incomplete bone marrow recovery(CRi): CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. Partial Remission/response(PR): >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. Nodular PR(nPR): persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population. Participants with unknown or missing responses were considered as non-responders. Only responders were included in the analysis.|||Months||95% Confidence Interval|Median
2757524|NCT00824265|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the last IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization up to 5 years after last dose of study drug|ITT Population.|||Months||95% Confidence Interval|Median
2757525|NCT00824265|Primary|Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia (CLL).|From randomization up to 5 years after last dose of study drug|Intent-to-Treat (ITT) Population: all participants randomized and received study drug.|||Months||95% Confidence Interval|Median
2757526|NCT00824161|Secondary|Overall Survival|Overall survival is defined as the period from the date of first dose of TAS-109 to death date.|From the initial treatment until 12 months after enrollment of the last patient.|Analysis was Intent to Treat(ITT) population.|||months||95% Confidence Interval|Median
2757527|NCT00824161|Secondary|Antitumor Activity|Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.|From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.|Intent to treatment(ITT)|||percentage of CR plus PR patients||95% Confidence Interval|Number
2757528|NCT00824161|Primary|Percentage of Progression Free Survival|The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.|From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.|Analysis was Intent to treatment(ITT) population.|||percentage of PFS patients||95% Confidence Interval|Number
2757530|NCT00824044|Primary|Percent Change in Relative Theta Power From Week 1 of the Ear Channel|Percent change between baseline and week 1 in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4|1 week|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||percent||Standard Deviation|Mean
2757531|NCT00824044|Primary|Change in Relative Theta Power From Ear Channel|Change between baseline and LOCF in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757532|NCT00824044|Primary|Change in Relative Theta Power From Temporal Channel|Change between baseline and LOCF in relative power of the theta wave recorded from the temporal channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The temporal channel refers to the average of channels 1 and 2|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757533|NCT00824044|Primary|Change in Absolute Beta Power From the Ear Channel|Change between baseline and LOCF in absolute power of the beta wave recorded from the ear channel of the EEG. The ear channel refers to the average of channels 3 and 4.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757534|NCT00824044|Primary|Change in Relative Beta Power From Channel 4|Change between baseline and LOCF in relative power of the beetawave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the beta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757535|NCT00824044|Primary|Change in Relative Theta Power From Channel 4|Change between baseline and LOCF in relative power of the theta wave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757536|NCT00824044|Primary|Change in Relative Theta Power Channel 3|Change between baseline and LOCF in relative power of the theta wave recorded from channel 3 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757537|NCT00824044|Primary|Change in Absolute Theta Power From Channel 1|Change between baseline and LOCF in relative power of the theta wave recorded from channel 1 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757538|NCT00824044|Primary|Change in Absolute Beta Power in Channel 4|Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
2757539|NCT00824044|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.|12 weeks|The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication)|||units on a scale||Standard Deviation|Mean
2757540|NCT00824005|Secondary|Reduction in Fixed Perfusion Defect(s)Via SPECT|Fixed total defect is the stress total defect minus the reversible component.|Measured at Baseline and Month 6|Only participants with both baseline and six month fixed defect data available are included.|||percentage of defect that is fixed||Standard Deviation|Mean
2757541|NCT00824005|Secondary|Incidence of a Major Adverse Cardiac Event|"Incidence of major adverse cardiac events (new MI, rehospitalization for PCI in coronary artery territories that were treated, death, or rehospitalization for acute coronary syndrome and for congestive heart failure).~(Incidence rate)"|Measured at Baseline and Month 6|Incidence of major adverse cardiac events between baseline and 6 months. (Incidence rate)|||events|||Number
2757542|NCT00824005|Secondary|LV Diastolic Dimension|Left ventricular (LV) diastolic dimension as assessed by contrast echocardiography|Measured at Baseline and Month 6|Only participants with both baseline and six month LV diastolic data available are included.|||mL||Standard Deviation|Mean
2757543|NCT00824005|Secondary|Serum BNP Levels in Patients With CHF|Serum b-type natriuretic peptide (BNP) levels in patients with congestive heart failure (CHF). A minority number of patients had pro-BNP collected versus regular BNP; these numbers are reported in the analysis population description.|Measured at Baseline and Month 6|Only participants with both baseline and six month BNP data available are included.|||IUs||Standard Deviation|Mean
2757544|NCT00824005|Secondary|Exercise Time and Level|Exercise time and level as assessed via six minute walk test. (change in number of feet walked)|Measured at Baseline and Month 6|Only participants with both baseline and six month 6 minute walk data available are included.|||feet||Standard Deviation|Mean
2757545|NCT00824005|Secondary|Number of Participants With a Decrease in Anti-anginal Medication|Number of participants with a decrease in anti-anginal medication (nitrates needed weekly)|Measured at Baseline and Month 6|Only participants with both baseline and six month anti-anginal medication data available are included.|||participants|||Number
2757546|NCT00824005|Secondary|Clinical Improvement in NYHA Classification|"Clinical improvement in New York Heart Association (NYHA) classification. The NYHA scale ranges from 1 (best)Mild- no limitation of physical activity due to heart failure to 4 (worst) Severe-Unable to carry out any physical activity without discomfort due to heart failure. Patients receive a rating of 1-4 for their heart failure symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month NYHA class data available are included.|||units on a scale||Standard Deviation|Mean
2757547|NCT00824005|Secondary|Clinical Improvement in CCS Classification (Angina Pectoris)|"Clinical improvement in Canadian Cardiovascular Society (CCS) functional classification of angina pectoris. The CCS scale ranges from Class I (best)able to conduct ordinary daily activity without causing angina to Class IV (worst) Inability to perform any physical activity without discomfort; anginal symptoms may be present at rest. Patients receive a rating of 1-4 for their anginal symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month CCS data available are included.|||units on a scale||Standard Deviation|Mean
2757548|NCT00824005|Secondary|Regional Wall Motion by Echocardiography|Movement of the left ventricular wall measured in mm from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and six month wall motion data available are included.|||mm||Standard Deviation|Mean
2757549|NCT00824005|Secondary|Regional Blood Flow Improvement by MRI (in Eligible Patients)|Regional blood flow improvement as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.||||||
2757550|NCT00824005|Secondary|Regional Wall Motion by MRI (in Eligible Patients)|Regional wall motion as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.||||||
2757551|NCT00824005|Primary|Change in Reversible Defect Size|Adenosine myocardial perfusion (SPECT) tests were collected at baseline and 6 months to identify change in ischemic (reversible) defects. SPECT imaging was performed at rest and after adenosine infusion over 4 minutes. To enhance the detection of viability on resting images, sublingual nitroglycerin was administered 15 minutes before injecting technetium Tc 99m sestamibi for the resting image.|Measured at Baseline and Month 6|Only participants with both baseline and six month reversible defect data available are included.|||percentage of reversible defect||Standard Deviation|Mean
2757552|NCT00824005|Primary|Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo|Echocardiographic measurements were performed by an echocardiographic core laboratory. LVESVs were calculated by the modified biplane Simpson method, using myocardial contrast to enhance endocardial definition. To account for patient body surface area, LVESV indices are reported.|Measured at Baseline and Month 6|Only participants with both baseline and six month LVESV data available are included.|||mL/m2||Standard Deviation|Mean
2757553|NCT00824005|Primary|Change in Maximal Oxygen Consumption (VO2max)|The VO2(max) is assessed using the Naughton treadmill protocol.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month VO2max data available are included.|||mL/kg/min||Standard Deviation|Mean
2757554|NCT00823979|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, the ability to interpret the pharmacokinetic/pharmacodynamic (PK/PD) results was limited, thus the data was not reported.||||||
2757555|NCT00823979|Secondary|Population Pharmacokinetics (PK) of Lersivirine|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48|||||||
2757556|NCT00823979|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included blood chemistry, hematology and urinalysis.|Baseline up to Week 48 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2757557|NCT00823979|Secondary|Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48|Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load >500 copies/mL at treatment failure, up to Week 48.|Baseline through Week 48|Virology analysis set included a subset of participants from TLOVR50 failures who had valid genotypic or phenotypic susceptibility testing result and with plasma HIV-1 RNA >500 copies/mL at baseline and treatment failure.|||participants|||Number
2757558|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.|||percentage of total lymphocytes||Standard Deviation|Mean
2757559|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
2757653|NCT00823615|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||LogMAR||Standard Deviation|Mean
2757560|NCT00823979|Secondary|Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response (50 denotes lower limit of quantification [LLOQ] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure [TF] criteria). TF: an increase of at least (>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL); HIV-1 RNA <1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement >=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT.Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24,48 weeks were considered to have plasma HIV-1 RNA>=50 copies/mL;were referred as failure. Due to early termination of study,decision was made not to derive TLOVR50 responder analysis for Week 96.|||percentage of participants|||Number
2757561|NCT00823979|Secondary|Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as (area under the curve of HIV-1 RNA levels [log10 copies/mL] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.|Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: TAD imputed as zero; not discontinued but observation was missing at visit: TAD to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: TAD imputed as zero.|||log10 copies/mL||Standard Deviation|Mean
2757562|NCT00823979|Secondary|Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.|||log10 copies/mL||Standard Deviation|Mean
2757563|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24, 48, 96|ITT population. Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24, 48, 96 weeks were considered to have plasma HIV-1 RNA >=400 copies/mL and referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.|||percentage of participants|||Number
2757564|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Weeks 48, 96|ITT population. Participants who died, discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 48, 96 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.|||percentage of participants|||Number
2757565|NCT00823979|Primary|Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24|ITT population. Participants who died, discontinued, lost to follow-up, switched/changed dose of anti-retro viral (ARV) drug not allowed by protocol, had missing plasma HIV-1 RNA data at 24 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure.|||percentage of participants|||Number
2757566|NCT00823966|Primary|Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).|"Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.~Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.~Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category."|One year|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.|||participants|||Number
2757567|NCT00823966|Primary|Number of Participants Who Reported Unlisted Adverse Drug Reaction.|Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).|One Year|The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.|||participants|||Number
2757568|NCT00823901|Primary|Mean Change in Number of Inflammatory Lesions From Baseline to Week 12|The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.|Baseline, week 12|Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used.|||lesions||Standard Deviation|Mean
2757569|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 54) was the event, and participants who had completed the study were censored.|0-385 days (up to Week 54)|Long-FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
2757570|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."|||participants|||Number
2757571|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||participants|||Number
2757572|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at Week 54 minus On time with troublesome dyskinesias (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||hours||Standard Deviation|Mean
2757573|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent Off at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at Week 54 minus Off time (proportion) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of time||Standard Deviation|Mean
2757574|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at Week 54 minus Off time (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||hours||Standard Deviation|Mean
2757575|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on percent change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
2757576|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
2757577|NCT00823836|Secondary|Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The CGI-I assesses the participant's improvement or worsening of PD from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|Week 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
2757578|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
2757579|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
2757580|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."|||scores on a scale||Standard Deviation|Mean
2757581|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
2757582|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
2757583|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757584|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757585|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis."|||scores on a scale||Standard Deviation|Mean
2757586|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757587|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757588|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 (Baseline) in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score.|Week 54|Long-FAS: participants who were included in the FAS and entered into the Long-term Phase. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
2757589|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
2757590|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
2757591|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||participants|||Number
2757592|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||participants|||Number
2757593|NCT00823836|Secondary|"Mean Change From Week 24 in Awake Time Spent On With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 24 on On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 24. Participants who had 0 hour as On time with troublesome dyskinesias at Week 24 were excluded from the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were also not included in the analysis.|||hours||Standard Deviation|Mean
2757594|NCT00823836|Secondary|"Mean Change From Week 24 in Percentage of Awake Time Spent Off at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 24 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.|||percentage of time||Standard Deviation|Mean
2757595|NCT00823836|Secondary|"Mean Change From Week 24 in Awake Time Spent Off at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 24 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.|||hours||Standard Deviation|Mean
2757713|NCT00823082|Secondary|Need for Blood Products|Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed|During ICU stay (maximum 70 days)|Intent-to-treat set|||Units||Standard Error|Least Squares Mean
2758031|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 12 for On-ART Participants|Results reported are for HIV-1 RNA at week 12 for on-ART participants.|At week 12|Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.|||participants|||Number
2757596|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757597|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757598|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757599|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757600|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757601|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757602|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757603|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at Off) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is where PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|"Switching-FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values."|||scores on a scale||Standard Deviation|Mean
2757604|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at On) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757605|NCT00823836|Secondary|Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS: participants who were included in the FAS and progressed to the PR/XR Switching Phase. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.|||scores on a scale||Standard Deviation|Mean
2757606|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
2757607|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
2757608|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."|||participants|||Number
2757609|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||participants|||Number
2757610|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On time with troublesome dyskinesias is measured as a proportion using the following formula: (Sum of two days On time with troublesome dyskinesias [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time with troublesome dyskinesias is measured using the following formula: On time with troublesome dyskinesias (proportion) at FAP minus On time with troublesome dyskinesias (proportion) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of time||Standard Deviation|Mean
2757611|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||hours||Standard Deviation|Mean
2758032|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for On-ART Participants|Results reported are for HIV-1 RNA at study entry for on-ART participants.|At Entry|Analysis is based on all on-ART participants with HIV-1 RNA data at entry.|||participants|||Number
2757612|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. On time is measured as a proportion using the following formula: (Sum of two days On time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time is measured using the following formula: On time (proportion) at FAP minus On time (proportion) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of time||Standard Deviation|Mean
2757613|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Mean Change from Week 0 in On time (actual hours) was calculated as On time (hours) at FAP minus On time (hours) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||hours||Standard Deviation|Mean
2757614|NCT00823836|Secondary|"Mean Percent Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Percent change from Week 0 in Off time (proportion) is measured using the following formula: (Change from Week 0 in Off time [proportion]/Off time [proportion] at Week 0) x 100."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percent change||Standard Deviation|Mean
2757615|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of time||Standard Deviation|Mean
2757616|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||hours||Standard Deviation|Mean
2757617|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in percent change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of participants|||Number
2757618|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of participants|||Number
2757619|NCT00823836|Secondary|Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The CGI-I assesses the participant's improvement or worsening of PD from Baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of participants|||Number
2757620|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757621|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757622|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."|||scores on a scale||Standard Deviation|Mean
2757623|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757624|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
2757625|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757626|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 24 in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at Off) total score were not included in the analysis."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis."|||scores on a scale||Standard Deviation|Mean
2757627|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0."|Week 0 and FAP (up to Week 24)|"FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis."|||scores on a scale||Standard Deviation|Mean
2757628|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
2757714|NCT00823082|Secondary|Postoperative Blood Loss in First 12 Hours|Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours|ICU admission through 12 hours post-operative|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.|||mL||Standard Error|Least Squares Mean
2757629|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis.|FAP (up to Week 24)|FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation.|||percentage of participants|||Number
2757630|NCT00823836|Primary|Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.|Week 0 and FAP (up to Week 24)|Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2.|||scores on a scale||Standard Deviation|Mean
2757631|NCT00823823|Secondary|Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations|The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.|Up to 4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.|||participants|||Number
2757632|NCT00823823|Primary|Loss of Radius Fracture Reduction|The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.|4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.|||participants|||Number
2757633|NCT00823797|Secondary|Overall Survival|*inclusive of subjects still alive at time of last reporting.|Until death or last reported survival||||months||95% Confidence Interval|Median
2757634|NCT00823797|Secondary|Toxic Death|Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.|Up to 30 days after completion of study treatment||||Participants|||Count of Participants
2757635|NCT00823797|Secondary|PFS|Defined as the time from date of initial therapy to first objective documentation of tumor progression or death.|Up to progression or death, whichever came first, assessed up to 108 months||||months||95% Confidence Interval|Median
2757636|NCT00823797|Primary|PFS-6|Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.|At 6 months||||Participants|||Count of Participants
2757637|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts|Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population|||participants|||Number
2757638|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts|Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population|||participants|||Number
2757639|NCT00823719|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia|Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population|||participants|||Number
2757640|NCT00823719|Secondary|Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration <200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.|Study Day 1 up to approximately Study Day 63|Safety Population. Data are presented for those participants who contributed a sample.|||participants|||Number
2757641|NCT00823719|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2757642|NCT00823719|Secondary|Terminal Phase Half-life (t1/2) of Ofatumumab|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population|||hr||Geometric Coefficient of Variation|Geometric Mean
2757792|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2757643|NCT00823719|Secondary|Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3)|Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).|Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2757644|NCT00823719|Secondary|Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3)|Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.|Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2757645|NCT00823719|Secondary|Clearance (CL) of Ofatumumab|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2757646|NCT00823719|Secondary|Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3)|AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.|Cycle 3 (Study Day 43; 3 weeks)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2757647|NCT00823719|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3)|AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.|Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)|Pharmacokinetic Population: all participants (par.) exposed to ofatumumab from whom a pharmacokinetic sample was obtained and analyzed. Data for par. who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the par. attending each visit.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2757648|NCT00823719|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of treatment start and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population|||days||95% Confidence Interval|Median
2757649|NCT00823719|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population|||days||95% Confidence Interval|Median
2757650|NCT00823719|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood|CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of >2x10^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.|During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)|Stem Cell Mobilization Population. All participants in the PP Population in whom stem cell mobilization was attempted and CD34+ cell data are available.|||participants|||Number
2757651|NCT00823719|Secondary|Number of Participants With CR, as Assessed by the Investigator|CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population|||participants|||Number
2757652|NCT00823719|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|Per protocol (PP) Population: all participants who received at least one dose of ofatumumab. Participants with major protocol deviations that could have impacted the efficacy outcome, and participants not exposed to ofatumumab or without CD20+ aggressive lymphoma were excluded from assessment. CD, cluster of differentiation.|||participants|||Number
2757654|NCT00823615|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||LogMAR||Standard Deviation|Mean
2757655|NCT00823472|Secondary|Number of Cumulus Oocyte Complexes Obtained|Number of cumulus oocyte complexes obtained after ovum pick-up|one year||||oocytes||Standard Deviation|Mean
2757656|NCT00823472|Primary|Proportion of Top Embryos Per OPU.|Proportion of top embryos per ovum pick-up|1 year|ITT|||percentage embryos|||Number
2757657|NCT00823459|Secondary|To Assess the Correlation of Activation of the PI3K/mTOR Pathway With Survival|Survival of patients with p-S6 staining of >19% (activated pathway)|5 years|Patients for which the molecular marker PI3K pathway activation was available|||years||95% Confidence Interval|Median
2757658|NCT00823459|Secondary|Overall Survival (OS) in Patients Treated With RAD001.|Number of years from the day the patient started treatment until the date of death, an average of 5 years.|Time from registration till death, an average of 5 years|All patients in study|||years||95% Confidence Interval|Median
2757659|NCT00823459|Secondary|Objective Response Rate (ORR) in Patients Treated With RAD001.|Objective response is defined as complete or partial response as defined by RANO criteria as determined by MRI and steroid requirement. Complete response was defined by disappearance of all measurable disease with minimal or no steroids; a partial response was defined as 50% in sum of all products in perpendicular diameters of all measurable lesions with no new lesions on stable or decreasing steroids.|12 months|All patients who were treated with study drug|||participants|||Number
2757660|NCT00823459|Secondary|RAD001 Safety Profile in Patients With Recurrent LLG|Grade 4-5 treatment related adverse events as defined by CTCAE 3.0|13 months|All patients treated from the time of registration until discontinuation of study drug|||Participants|||Count of Participants
2757661|NCT00823459|Primary|Progression-free Survival at 6 Months.|Number of patients alive without progressive disease at 6 months. Assessment of progression was defined by RANO as a 25% increase in the sum of all the products of measurable lesions, clear worsening of any evaluable disease or any new lesion|At 6 months after treatment start|All patients treated with study drug|||Participants|||Count of Participants
2757662|NCT00823303|Primary|Confirmed Hypercalcemia|Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.|24 week treatment period||||participants|||Number
2757663|NCT00823264|Primary|Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels|We enrolled patients with elevated phenytoin levels into the study with greater than 30 ug/cc. The treatment arm received multiple doses of activated charcoal and the control arm received no activated charcoal. We obtained serum phenytoin levels every 6 hours for 24 hours then once every 24 hours. The time to reach a subtoxic level was determined in each arm by looking at serum phenytoin levels and documenting when it was below 25 ug/cc.|Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours||||hours||Inter-Quartile Range|Median
2757664|NCT00823212|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Acute-At time of index procedure|Analysis was intention to treat (all patients in the study).|||percentage of stents|Stents||Number
2757665|NCT00823212|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death|In hospital|Analysis was intention to treat (all patients in study).|||percentage of participants|||Number
2757666|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757667|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757668|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757669|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757670|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757671|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757672|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757673|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757674|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757675|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757676|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757677|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757678|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757679|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757680|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757681|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2758033|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants.|At weeks 12 and 24|Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.|||log10 copies/mL||Inter-Quartile Range|Median
2757682|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757683|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757684|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757685|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757686|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757687|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757688|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757689|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757690|NCT00823212|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757691|NCT00823212|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757692|NCT00823212|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of patients|||Number
2757693|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757694|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757793|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Terminal Slope (λz)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2757695|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757696|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757697|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757698|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757699|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757700|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2757701|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||Percentage of participants|||Number
2757702|NCT00823212|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12-month post index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.|||percentage of participants|||Number
2757703|NCT00823199|Post-Hoc|Uric Acid Level||Baseline and 4 weeks|2 subjects had missing data|||mg/dL||Standard Deviation|Mean
2757704|NCT00823199|Secondary|Simpson Angus Scale for Parkinsonism|Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)|baseline and 4 weeks||||score on scale||Standard Deviation|Mean
2757705|NCT00823199|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia|Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)|baseline and 4 weeks|Two subjects withdrew before the first week's evaluation|||scores on a scale||Standard Deviation|Mean
2757706|NCT00823095|Secondary|The Secondary Endpoint Measure is a Reduction on Wound Size.|reduction in bioburden as assessed by number of cfu's per cm2 on culture|28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform analysis.||||||
2757707|NCT00823095|Primary|The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.||at 28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform study analysis||||||
2757708|NCT00823082|Secondary|Length of Hospital Stay|Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.|During ICU stay (maximum 70 days)||||days||Inter-Quartile Range|Median
2757709|NCT00823082|Secondary|Mechanical Ventilation Duration||During ICU stay (maximum 70 days)|Intent-to-treat set|||Days||Inter-Quartile Range|Median
2757710|NCT00823082|Secondary|Percentage of Subjects With Renal Dysfunction|Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy|During ICU stay (maximum 70 days)|Intent-to-treat set|||Percentage of participants|||Number
2757711|NCT00823082|Secondary|Percentage of Subjects With Low Cardiac Syndrome|Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump|During ICU stay (maximum 70 days)|Intent-to-treat set. Three subjects in the Antithrombin III treatment group and 1 subject in the Control group were missing this data.|||percentage of participants|||Number
2757712|NCT00823082|Secondary|Percentage of Subjects Needing Surgical Re-exploration|Percentage of subjects needing surgical re-exploration resulting from bleeding|During ICU stay (maximum 70 days)|Intent-to-treat set. Two subjects in the Antithrombin III treatment group and 2 subjects in the Control group were missing this data.|||percentage of participants|||Number
2757715|NCT00823082|Secondary|Heparin Resistance|Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses|Immediately after anesthesia induction|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.|||percentage of participants|||Number
2757716|NCT00823082|Secondary|In-hospital Postoperative Mortality||70 days after ICU admission (maximum)|Intent-to-treat set. One subject in the control group was missing this data.|||percentage of participants|||Number
2757717|NCT00823082|Secondary|ICU Stay Duration||During ICU stay (maximum 70 days)|Intent-to-treat set. One subject in the control group was missing this data.|||days||Inter-Quartile Range|Median
2757718|NCT00823082|Secondary|Percentage of Patients With Thromboembolic Events|Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism|During ICU stay (maximum 70 days)|Intent-to-treat set|||percentage of participants|||Number
2757719|NCT00823082|Secondary|Percentage of Subjects With Adverse Neurologic Outcome|Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation|During ICU stay (maximum 70 days)|Intent-to-treat set|||percentage of participants|||Number
2757720|NCT00823082|Secondary|Percentage of Subjects With Postoperative Myocardial Infarction|Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram|During ICU stay (maximum 70 days)|Intent-to-treat set|||percentage of participants|||Number
2757721|NCT00823082|Primary|Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission|Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission|ICU admission|Intent-to treat set and Per-protocol set|||percentage of participants|||Number
2757722|NCT00823082|Primary|Postoperative ATIII Levels at the ICU Admission|Measurement of postoperative ATIII functional activity at ICU admission|ICU admission|Intent-to-treat set and Per-protocol set|||IU||Standard Deviation|Mean
2757723|NCT00823069|Secondary|Number of Subjects Showing Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline||||Participants|||Number
2757724|NCT00823069|Primary|Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm||After Injection on Day of Treatment|This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.|||Participants||95% Confidence Interval|Number
2757725|NCT00823043|Primary|Subject Reported Blurred Vision|Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation||||Units on a Scale||Standard Deviation|Mean
2757726|NCT00823043|Primary|Subject Reported Light Sensitivity|Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|Analysis includes all subjects that answered this question. One subject from each arm did not answer this question.|||Units on a Scale||Standard Deviation|Mean
2757727|NCT00823043|Primary|Subject Reported Tearing|Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation.||||Units on a Scale||Standard Deviation|Mean
2757728|NCT00823043|Primary|Subject Reported Burning/Stinging|Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation||||Units on a Scale||Standard Deviation|Mean
2757729|NCT00822926|Secondary|NRS Score Three Weeks After Injection|Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).|3 weeks after injection|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.|||Units on a scale||Standard Deviation|Mean
2757730|NCT00822926|Secondary|Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines|The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.|Duration of trial (2-20 months, depending on how long pain relief lasts)|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.|||Units on a scale||Standard Deviation|Mean
2757731|NCT00822926|Primary|Time to Analgesic Failure|Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.|Duration of trial (2-20 months, depending on how long pain relief lasts)|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.|||days||Standard Deviation|Mean
2757794|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2757732|NCT00822900|Secondary|Potentially Associated Adverse Events: Myocardial Infarction (MI)|Myocardial infarction - Events were defined based on serial cardiac enzyme elevation consistent with MI and/or new ST elevation on electrocardiogram (ECG) consistent with MI. Potentially associated adverse events (those events which are included as outcome measures) were specifically defined per the protocol, and the classification of an event as a PAAE was determined by the site. The reported name of the associated event, however, was subject to clinical judgement and case details; these were then further coded by the Principal Investigator. Since these data points do not share the same definition, there is no reason to expect perfect concordance. (For example, the potentially associated adverse event of myocardial infarction may include MedDRA codes other than myocardial infarction.)|within 6 months||||participants|||Number
2757733|NCT00822900|Secondary|Potentially Associated Adverse Events: Central Nervous System (CNS) Infection|CNS infection - Events must have met Centers for Disease Control and Prevention (CDC) definition of CNS infection. The definition includes intracranial infection, Meningitis, ventriculitis, and spinal abscess without meningitis.|within 6 months||||participants|||Number
2757734|NCT00822900|Secondary|Potentially Associated Adverse Events: Pneumonia|Events must have met Centers for Disease Control and Prevention (CDC) definition of pneumonia. There are three specific types of pneumonia: clinically defined pneumonia, pneumonia with specific laboratory findings, and pneumonia in immunocompromised patients. There are specific algorithms to identify each pneumonia, which include x-ray findings, fever with no other cause, leukopenia or leukocytosis, altered mental status with no other cause (adults >70 years old), new onset of purulent sputum, change in character of sputum, increase respiratory secretions, increase suctioning requirements, new onset or worsening cough, dyspnea, tachypnea, rales, bronchial breath sounds, or worsening gas exchange, increased oxygen requirements, or increased ventilator demand). Also, labs can identify pneumonia such as positive growth in blood culture, positive Gram stain, and histopathologic exam evidence.|within 6 months||||participants|||Number
2757735|NCT00822900|Secondary|Potentially Associated Adverse Events: Sepsis|Sepsis - Events must have met Centers for Disease Control and Prevention (CDC) definition of sepsis. The definition includes that a patient ≤1 year of age has at least 1 of the following clinical signs or symptoms with no other recognized cause: fever (>38°C rectal), hypothermia (<37°C rectal), apnea, or bradycardia, and blood culture not done or no organisms detected in blood and no apparent infection at another site and physician institutes treatment for sepsis.|within 6 months||||participants|||Number
2757736|NCT00822900|Secondary|Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level|Unexplained increased liver enzymes (e.g. not due to liver injury ) - Events were defined based on aspartate transaminase (AST) and alanine transaminase (ALT) levels > 500 U/L and/or total bilirubin levels > 2.0 mg/dL.|within 6 months||||participants|||Number
2757737|NCT00822900|Secondary|Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)|DVT - Events were defined based on a positive Doppler ultrasound exam|within 6 months||||participants|||Number
2757738|NCT00822900|Secondary|Potentially Associated Adverse Events: Acute Ischemic Stroke|Acute ischemic stroke - Events were defined based on either positive computed tomography (CT) scanning, magnetic resonance imaging (MRI), or neurologist diagnosis of cerebrovascular accident (CVA)|within 6 months||||participants|||Number
2757739|NCT00822900|Secondary|Potentially Associated Adverse Events: Pulmonary Embolism|Pulmonary embolism - Events were defined based on either positive chest computed tomography (CT) scanning or ventilation/perfusion lung scan (V/Q).|within 6 months||||participants|||Number
2757740|NCT00822900|Secondary|Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis|Phlebitis/Thrombophlebitis (not due to infiltration or misplacement of the IV)|within 6 months||||participants|||Number
2757741|NCT00822900|Secondary|Disability Rating Scale|A measure of functional impairment, with complete recovery scored a 0 and vegetative state scored a 29.|6 months||||units on a scale||Standard Deviation|Mean
2757742|NCT00822900|Secondary|Mortality||6 months||||participants|||Number
2757743|NCT00822900|Primary|Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)|A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.|6 months post randomization|The primary analysis was conducted according to intention to treat.|||participants|||Number
2757744|NCT00822770|Secondary|Response Rate (Engraftment Versus Graft Failure)|Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.|100 Days post engraftment|||||||
2757745|NCT00822770|Secondary|Time to Failure|Time to treatment failure defined as either disease recurrence or death, measured in months.|Baseline till disease progression/death, up to 1 year.|||||||
2757746|NCT00822770|Primary|Maximum Tolerated Dose (MTD) Plerixafor|MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).|28 day cycle (Plerixafor Day -7 to Day -4)||||mg/kg|||Number
2757747|NCT00822757|Other Pre-specified|GMFR in Antibody Concentration From Baseline|An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.|Prevaccination to Days 10, 14, 28, and 84 postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2757795|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2757748|NCT00822757|Other Pre-specified|GMFR by Age|Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.|Prevaccination to 14 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2757749|NCT00822757|Primary|Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).|Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).|Prevaccination to 14 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2757750|NCT00822692|Primary|Recurrence Rates of Abscesses|Number of patient with a new abscess in same or different location as previous lesion|30 days after incision and drainage||||participants|||Number
2757751|NCT00822679|Secondary|Changes in Objective and Subjective Measures of Sleep||4 days|||||||
2757752|NCT00822679|Primary|Changes in Circulating Inflammatory Cytokines (Interleukin [IL]-1B, IL-6, IL-10, and Tumor Necrosis Alpha [TNF-α]) and Pro-coagulant Mediators (Soluble P-selectin and CD40 Ligand).|Not performed. Zero subjects were randomized. Many potential participants screen-failed.|2 days|Not performed. Zero subjects were randomized. Many potential participants screen-failed.||||||
2757753|NCT00822588|Primary|Number of Participants in Need for Bank Blood Transfusion|"Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared.~The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)"|At discharge|Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled.|||Participants|||Number
2757754|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757755|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757756|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757796|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2758034|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants.|At Entry|Analysis is based on all off-ART participants with HIV-1 RNA data at entry.|||log10 copies/mL||Inter-Quartile Range|Median
2757757|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757758|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757759|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757760|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757761|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757797|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)|AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
2757762|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757763|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757764|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757765|NCT00822523|Secondary|Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB.|Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject.|Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4||||percent change from baseline||Standard Deviation|Mean
2757766|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
2757767|NCT00822523|Secondary|Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin)||At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4)||||participants|||Number
2757798|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)|Blood samples were collected at following time points: -30 min, -20 min, -10 min, 5 min, 10 min, 20 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 8h, 12h and 24h to calculate area under the curve.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
2757768|NCT00822523|Secondary|Difference in Force From Day 14 to Day 21|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group.|Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB.||||percent change from baseline||Standard Deviation|Mean
2757769|NCT00822523|Secondary|Stability of Baseline Measurements of Force|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement.|Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing)|Normal controls at baseline before BoNT/A injected|||kg||Standard Deviation|Mean
2757770|NCT00822523|Primary|"Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB"|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values.|Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4||||kg||Standard Deviation|Mean
2757771|NCT00822510|Primary|Spiritual Well Being|Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
2757772|NCT00822510|Primary|Social Well Being|Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
2757773|NCT00822510|Primary|Multidimensional Fatigue Inventory|Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
2757774|NCT00822510|Primary|Negative Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
2757775|NCT00822510|Primary|Positive Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
2757776|NCT00822510|Primary|Perceived Stress|Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
2757777|NCT00822510|Primary|Center for Epidemiological Studies-Depression Scale|Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.|3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks|Badger, T.A., Segrin, C., Figueredo, A.J., Harrington, J., Sheppard, K., Passalacqua, S., Pasvogel, A., & Bishop, M. (2011) Psychosocial Interventions to Improve Quality of Life in Prostate Cancer Survivors and their Intimate or Family Partners. Quality of Life Research. 20 (6), 833-844 [epub Dec 2010]. PMID: 21170682; PMCID: PMC3117079|||units on scale||Standard Deviation|Mean
2757778|NCT00822354|Primary|Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.|||millimeters||Full Range|Median
2757779|NCT00822354|Secondary|Capillary Diameter|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 8, Baseline/Week 0 data was used for both Pre-treatment and Pre-placebo, and Week 2 data was used for Week 4 of placebo.|||micrometers||Full Range|Median
2757901|NCT00820573|Secondary|Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline|The absolute values of mean plasma glucose post-meal (360 minutes)were determined after each specific 6 week treatment and these absolute values after each specific sequence therapy were compared amongst all groups.|360 min|power calculation based on previous data|||mg/dl||Standard Error|Mean
2757780|NCT00822354|Secondary|Digital Blood Pressure|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 10, Week 2 data was used for Week 4 of placebo because digital blood pressure data was not obtained at the Week 4 visit.|||mm Hg||Full Range|Median
2757781|NCT00822354|Primary|Raynaud Severity Visual Analog Score (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.|||millimeters||Full Range|Median
2757782|NCT00822354|Primary|Duration of Raynaud's Phenomenon Attacks|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.|||minutes||Full Range|Median
2757783|NCT00822354|Primary|Number of Raynaud's Phenomenon Attacks Per Day|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.|||Raynaud's attacks per day||Full Range|Median
2757784|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.~Clostridium perfringens was cultured.Bacterial colonies were counted."|week 0, 1, 2, 3, 4, 5, 6.||||log10 CFU/g||Standard Deviation|Log Mean
2757785|NCT00822328|Secondary|Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.~Bacterial colonies were cultured and counted."|at week 0, 1, 2, 3, 4, 5, 6||2009-03-31|03/2009||||
2757786|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Bifidobacterium|Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.|week 0, 1, 2, 3, 4, 5, 6.|The number of participants for analysis was per protocol analysis.|||log10 CFU/g||Standard Deviation|Log Mean
2757787|NCT00822237|Primary|Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).|"Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL.~Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only."|6 weeks following first vaccination|Per protocol population|||Percent of participants|||Number
2757788|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)|Mean residence time of the unchanged drug in the systemic circulation|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||hours||Geometric Coefficient of Variation|Geometric Mean
2757789|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2757790|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subject did not contribute to PK evaluation.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2757791|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Total Clearance (CL)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subjects did not contribute to data.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2757799|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)|AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
2757800|NCT00822185|Primary|Subjects With Anti-Vatreptacog Alfa Antibody|Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody|between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.|||participants|||Number
2757801|NCT00822185|Primary|Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))|Any safety issue was reported as AE|between dosing and 2-3 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.|||number of events|||Number
2757802|NCT00822172|Secondary|Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 90|Subjects completed the Walking Impairment Questionnaire (WIQ) whereby they were asked about their maximal walking distance before having to rest as a result of claudication symptoms associated with their peripheral artery disease (PAD). The WIQ was administered at the Baseline, Day 90, and Day 180 visits. On the WIQ subjects were asked a series of questions related to their degree of physical difficulty that best described how hard it was for the subject to walk on level ground without stopping to rest. The questions began by asking the degree of difficulty walking around indoors, then 50 feet, 150 feet, 300 feet, 600 feet, 900 feet, and lastly 1500 feet. The responses range from None (best outcome) to Slight, then Some, then Much, then lastly Unable (worst outcome). The walking distance score was calculated from the 7 questions in the section by way of a weighted sum. A score of 100 indicated no walking impairment. A score of 0 corresponded to the highest degree of walking impairment|Baseline, Day 90|modified Intent to Treat Population (mITT)|||score on a scale||Standard Deviation|Mean
2757803|NCT00822172|Secondary|Change From Baseline in Walking Impairment Questionnaire for Walking Distance at Day 180|Subjects completed the Walking Impairment Questionnaire (WIQ) whereby they were asked about their maximal walking distance before having to rest as a result of claudication symptoms associated with their peripheral artery disease (PAD). The WIQ was administered at the Baseline, Day 90, and Day 180 visits. On the WIQ subjects were asked a series of questions related to their degree of physical difficulty that best described how hard it was for the subject to walk on level ground without stopping to rest. The questions began by asking the degree of difficulty walking around indoors, then 50 feet, 150 feet, 300 feet, 600 feet, 900 feet, and lastly 1500 feet. The responses range from None (best outcome) to Slight, then Some, then Much, then lastly Unable (worst outcome). The walking distance score was calculated from the 7 questions in the section by way of a weighted sum. A score of 100 indicated no walking impairment. A score of 0 corresponded to the highest degree of walking impairment|Baseline, Day 180|modified Intent to Treat Population (mITT)|||score on a scale||Standard Deviation|Mean
2757804|NCT00822172|Secondary|Change From Baseline in Claudication Onset Time at Day 90|Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. The time during the conduct of the exercise treadmill test at which the subject first reported claudication symptoms is referred to as the claudication onset time (COT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.|Baseline, Day 90|modified Intent to Treat Population (mITT)|||Log Minutes||Standard Deviation|Mean
2757805|NCT00822172|Secondary|Change From Baseline in Claudication Onset Time at Day 180|Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. The time during the conduct of the exercise treadmill test at which the subject first reported claudication symptoms is referred to as the claudication onset time (COT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.|Baseline, Day 180|modified Intent to Treat Population (mITT)|||Log Minutes||Standard Deviation|Mean
2757806|NCT00822172|Secondary|Change From Baseline in Peak Walking Time at Day 90|Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. This maximum time walked is referred to as the peak walking time (PWT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.|Baseline, Day 90|modified Intent to Treat Population (mITT)|||Log Minutes||Standard Deviation|Mean
2757807|NCT00822172|Secondary|Change From Baseline in Peak Walking Time at Day 180|Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. This maximum time walked is referred to as the peak walking time (PWT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.|Baseline, Day 180|Per Protocol (PP) Population|||Log Minutes||Standard Deviation|Mean
2757808|NCT00822172|Primary|Change From Baseline in Peak Walking Time (PWT) at Day 180|Subjects were asked to complete a standardized exercise treadmill test using a modified Gardner protocol. Subjects walked on the treadmill until they were physically unable to walk further either as a result of their peripheral artery disease (PAD) symptoms or other non-PAD symptoms. This maximum time walked is referred to as the peak walking time (PWT) and reported in minutes/seconds. The exercise treadmill test was conducted at Screening, Baseline, Day 90, and Day 180 visits. The log transformation is used to make highly skewed distributions less skewed.|Baseline, Day 180|modified Intent to Treat Population (mITT)|||Log Minutes||Standard Deviation|Mean
2757809|NCT00822120|Secondary|Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year|Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2757810|NCT00822120|Secondary|Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|7 months after registration|Eligible and evaluable HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.|||Participants|||Count of Participants
2757811|NCT00822120|Secondary|Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|5 years|Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of participants||95% Confidence Interval|Number
2757812|NCT00822120|Secondary|Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|2 years|Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of patients||95% Confidence Interval|Number
2757813|NCT00822120|Secondary|Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year|Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Count of Participants
2757814|NCT00822120|Secondary|Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|7 months after registration|Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis|||percentage of patients||95% Confidence Interval|Number
2757815|NCT00822120|Secondary|Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|2 years|Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of participants||95% Confidence Interval|Number
2757829|NCT00821964|Primary|Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria|"Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).~Evaluation of target lesions per modified WHO response criteria:~Complete response (CR): complete clearance (100%) of target lesion(s)~Partial response (PR): ≥ 50% decrease in target lesion size~Stable disease (SD): < 50% decrease in target lesion size~Progressive (PD): ≥ 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received."|Baseline and then every 4 weeks until week 24||||Participants|||Count of Participants
2757816|NCT00822120|Primary|Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|2 years|Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2757817|NCT00822120|Primary|Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|2 years|Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of participants||95% Confidence Interval|Number
2757818|NCT00822107|Primary|Chloriuretic Response to a Thiaizde|Change from baseline in fractional chloride excretion in response to a single dose of hydrochlorothiazide|6 hours||||fractional chloride excretion||Standard Deviation|Mean
2757819|NCT00822094|Secondary|Rate of Stem Cell Transplant|Number of patients transferred for stem cell transplant|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2757820|NCT00822094|Secondary|Rate of Aplasia|Patients with Aplasia During Study|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2757821|NCT00822094|Secondary|Remission Duration|Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.|Following achievement of CR and up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||days||Full Range|Median
2757822|NCT00822094|Secondary|Event Free Survival|Progression EFS median|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
2757823|NCT00822094|Secondary|Complete Remission Rate||Following 1st induction, following 2nd induction if applicable|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2757824|NCT00822094|Primary|Proportion of Subjects Surviving at 1 Year|The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.|Up to 1 year from randomization|Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2757825|NCT00821964|Secondary|Incidence of Reduction of Serum TGF-beta Levels as Assessed by ELISA and Correlation With Th1 Adaptive Immunity and Clinical Response|Incidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response is defined as a reduction of at least 25% from baseline value to the value measured at week 13.|Baseline and at weeks 13||||Participants|||Count of Participants
2757826|NCT00821964|Secondary|Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay|Peripheral blood will be obtained at baseline, after cycle 3 (end of study treatment) and at week 24 (end of study) to assess the immune response. A positive antigen-specific T cell immune response will be defined as a T cell precursor frequency more robust than 1:20,000 PBMC if the patients did not have a detectable response prior to treatment. In patients with a pre-existent immune response, the development of an immune response twice baseline will constitute augmentation.|Baseline and at weeks 13 and 24||||Participants|||Count of Participants
2757827|NCT00821964|Primary|Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion|This is done by IHC staining reviewed by a pathologist. This is done by comparing the baseline to the post-treatment biopsy tissue. Yes equals absence of residual disease.|Pre-and post-treatment||||Participants|||Count of Participants
2757828|NCT00821964|Primary|Safety and Systemic Toxicity as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP)|"Evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and monitoring of adverse events will be done per Food and Drug Administration (FDA) and National Cancer Institute (NCI) guidelines for the time frame below.~Number of Participants with at Least 1 Adverse Event as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP) under the following CTCAE categories:~Constitutional (Fatigue) Neurological (Neuropathy (sensory or motor)) Cardiac (Arrhythemia) Pulmonary (Cough, Pharyngitis) GI (Constipation, Diarrhea, Mucositis, Vomiting) Dermatology (Ulceration, Hairloss/alopecia) Pain (Headache, other pain) Syndrome (Flu-like) Visual Changes Hearing/Auditory Edema Other (General)~In addition they were asked the severity of the event so that a clinician could grade the event."|Baseline and weeks 5, 9 13, 16, 20, and 24||||Participants|||Count of Participants
2757837|NCT00821873|Primary|MRI to Evaluate Success of Outcome.|"The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.~The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score."|24 months||||units on a scale||Standard Deviation|Mean
2757838|NCT00821821|Secondary|mRS, NIHSS, Barthel Index||throughout study|||||||
2757839|NCT00821821|Secondary|Plasma MCI-186 Pharmacokinetics|The geometric mean values of MCI-186 plasma concentration at the end of the infusion (at 72h) in cohorts 1 and 2 were determined.|72 hours|The subjects with reliable measured values for plasma concentration were selected for pharmacokinetic analysis: 5 subjects in MCI-186 Cohort 1 and 11 subjects in MCI-186 Cohort 2.|||ng / ml||Geometric Coefficient of Variation|Geometric Mean
2757840|NCT00821821|Primary|Number of Participants That Experienced Adverse Events|Additional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.|87days||||participants|||Number
2757841|NCT00821795|Secondary|Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter||daily|||||||
2757842|NCT00821795|Secondary|Hypoglycemia||daily|||||||
2757843|NCT00821795|Secondary|Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control||16 weeks|||||||
2757844|NCT00821795|Secondary|Seven Point Blood Glucose Profiles|mg/dl|2 weeks|||||||
2757845|NCT00821795|Primary|For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase.|Hemoglobin A1c|16 weeks||||% hemoglobin A1c||Standard Deviation|Mean
2757846|NCT00821678|Secondary|Received at Least 8 Sessions of Exposure Based Therapy|0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy|12 months|Full Baseline Sample|||participants|||Number
2757847|NCT00821678|Secondary|Medication Adherence, Defined as Taking Medication <80% of Days|0 - taking medication <80% of days; 1 - taking medications >=80%|6 months|Sample only for 205 patients prescribed medications.|||participants|||Number
2757848|NCT00821678|Secondary|Satisfaction With Care (ECHO)|Using any number from 0 to 10, where 0 is the worst care possible and 10 is the best care possible, what number would you use to rate all the care you received for personal or emotional problems in the last 6 months?|6 months|Full sample. Data missing for 1 Arm 1 subject and 3 Arm 2 subjects|||0-10 self reported rating||Standard Deviation|Mean
2757849|NCT00821678|Secondary|Change in Continuous Measure of Quality of Life (QWB)|range - 0-1 (higher score represents greater wellbeing)|Baseline, 6 months|Full sample|||Units on a Scale from 0-1||Standard Deviation|Mean
2757850|NCT00821678|Secondary|Change in Continuous Measure of Health Status (SF12V PCS)|range - 0-100 (higher score represents greater physical health status)|6 months||||units on a scale||Standard Deviation|Mean
2757851|NCT00821678|Secondary|Change in Continuous Measure of Alcohol Use (Audit Score)|range - 0-12 (higher score represents greater severity)|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2757852|NCT00821678|Secondary|Change in Continuous Measure of Depression Symptom Severity (SCL-20)|range - 0-4 (higher score represents greater severity|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2757853|NCT00821678|Primary|Change in PTSD Symptom Severity (PDS)|range - 0-51 (higher score represents greater severity)|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2757854|NCT00821626|Secondary|Number of Patients Receiving a Prescription for Antibiotics||4 years||||Participants|||Count of Participants
2757855|NCT00821626|Secondary|Chest X-ray Requested|Number of patients for whom a chest X-ray was requested as part of the medical management|4 years||||Participants|||Count of Participants
2757856|NCT00821626|Primary|Cost for the Medical Management of Patients||4 years||||USD||95% Confidence Interval|Mean
2757857|NCT00821587|Primary|Hepatitis C Viral Level|Undetectable or <100 COPIES/ML|6 months after completion of interferon based therapy|Randomization was performed using computer-generated random numbers. 150 patients were eligible and 39 met entry criteria for enrollment in the study. Subjects with HCV recurrence (Ishak Stage2) were randomized to TAC or to change to CsA before initiation of therapy with PEGa-2a and ribavirin for 48 weeks for genotype-1,or 24 weeks for genotype-3.|||Participants|||Number
2757858|NCT00821509|Primary|Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI). Individual weekly reports were combined in a single continuum and successive days with either RTI or GTI symptoms were designated as disease episodes due. Numbers of RTI, GTI and either episodes in each trial arm were calculated, and for the respective proportion, were divided by the total number of weekly reports collected in the arm.|At the end of the study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants|||Disease episodes|Participants||Number
2757859|NCT00821509|Primary|Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI) as well as whether they were working (if expected) or not, daily for the previous calendar week. Individual weekly reports were combined in a single continuum and successive days with both symptoms and absence from work were designated as days-off episodes due to own infectious disease. Number of these episodes in each trial arm was calculated and for the respective proportion, was divided by the total number of weekly reports collected in the arm.|At the end of the entire study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants|||sick-leave episodes|Participants||Number
2757860|NCT00821431|Secondary|Healing Measured by Number of Subjects Healed During the 12 Week Study Period||12 weeks||||Number of subjects healed|||Number
2757863|NCT00821327|Secondary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."|2 years|ITT population|||Month||Full Range|Median
2757864|NCT00821327|Primary|Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|All eligible patients who meet the protocol-specified efficacy analyses requirements and who have received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2757865|NCT00821236|Primary|1 Month Postoperative Lasik Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Month Postoperative||||LogMar||Standard Deviation|Mean
2757866|NCT00821236|Primary|1 Week Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 week post op||||LogMar||Standard Deviation|Mean
2757867|NCT00821236|Primary|1 Day Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Day||||LogMar||Standard Deviation|Mean
2757868|NCT00821184|Secondary|Improvement of Symptom Severity||3 months|data were not collected||||||
2757869|NCT00821184|Primary|Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.||0 week - 12 weeks||||incontinence episodes per 24 hours||Full Range|Mean
2757870|NCT00821119|Secondary|Bronchopulmonary Dysplasia|The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.|at 36 weeks gestational age|The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis|||participants|||Number
2757871|NCT00821119|Primary|Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)|The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit|first 3 days of life(72hours)|We estimated a 20% absolute reduction in the need of using endotraqueal ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.|||participants|||Number
2757872|NCT00821119|Primary|Need for Endotracheal Ventilation in the First 72 hs of Life|number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life|first 72 hs of life|40 - 45% of our previous preterm infants on NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.|||participants|||Number
2757873|NCT00821093|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2757874|NCT00821093|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2757875|NCT00821041|Secondary|Beliefs and Attitudes About Sleep||6 weeks|||||||
2757876|NCT00821041|Secondary|Pre-Sleep Arousal|Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.|6 weeks||||PSA Scale||Standard Deviation|Mean
2757877|NCT00821041|Primary|Sleep Quality|"Sleep Quality was assessed by taking the average of two items: How well do you feel this morning? And How enjoyable was your sleep last night? (0 = not at all, 4 = very)."|6 weeks||||0-4 scale of sleep quality||Standard Deviation|Mean
2757878|NCT00821015|Secondary|Atrial Flutter|1. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure|3 months|Data about atrial flutter procedural success were not collected for any participant in the study for this outcome measure.||||||
2757912|NCT00820248|Secondary|Overall Survival Rate|"Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive.~Number of death and alive patients will be reported."|6.2 years||||Participants|||Count of Participants
2757879|NCT00821015|Secondary|Chronic Treatment Success for the Follow-up Visit Within Treatment Windows.|Chronic Treatment Success for the follow-up visit within treatment windows. 1. Whether on or off Atrial Fibrillation Drugs (AFDs) during the Non-blanked Follow-up Period 2. When off Atrial Fibrillation Drugs|3 months|Data about atrial fibrillation drugs during the 3 month period were unfortunately not collected for any participant in the study for this outcome measure.||||||
2757880|NCT00821015|Primary|Deflections of the Mitral Annulus Measurement|Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF Deflections of the mitral annulus as measured by peak early ventricular diastolic velocity (E'), and during atrial contraction (A')|Baseline and 6 months|Echocardiographic data was incomplete for 9 participants|||cm/s||Standard Deviation|Mean
2757881|NCT00821015|Primary|Left Atrial Volume|Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF|Baseline and 6 months|Echocardiogram data was incomplete for 9 patients.|||ml||Standard Deviation|Mean
2757882|NCT00821015|Primary|LVEF|Ventricular Function measured by Left Ventricular Ejection Function (LVEF). A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. An LVEF of 65%, for example means that 65% of total amount of blood in the left ventricle is pumped out with each heartbeat.|Baseline and 6 months|Echocardiogram data was incomplete for 9 patients.|||percentage of blood||Standard Deviation|Mean
2757883|NCT00821015|Primary|Left Atrial Measurements|"Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF~Parameters of atrial function:~Volumes at P-wave onset and end-systole~LA active emptying volume~LA active emptying fraction~Late diastolic peak velocity~LA filling fraction~Pulmonary venous inflow pattern"|Baseline and 6 months|Echocardiogram data was incomplete for 9 patients.|||cm||Standard Deviation|Mean
2757884|NCT00821015|Primary|Number of Participants With AF Recurrence|"Number of Participants with AF Recurrence at 6 months and at 12 months after Cryoballoon Ablation for Atrial Fibrillation.~(Chronic Treatment Success is defined as a subject who does not have episodes of AF, lasting at least 30 seconds in duration, 3 months following the initial ablation procedure.)"|6 months and 12 months|Only subjects who returned for their visit was included in analysis|||Participants|||Count of Participants
2757885|NCT00821015|Primary|Number of Participants With Acute Procedural Success (APS)|Acute Procedural Success (APS) is the demonstration of electrical isolation of all 4 PVs or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.|Immediately following procedure||||Participants|||Count of Participants
2757886|NCT00820898|Primary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||Participants|||Count of Participants
2757887|NCT00820898|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
2757888|NCT00820872|Primary|Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0||Up to 10 years|All evaulable patients|||percentage of patients|||Number
2757889|NCT00820755|Primary|Percentage of Participants With 1-year Overall Survival|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. Percentage of participants who were still alive until one year after the last participant was included (March 2010).|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until one year after the last participant was included (March 2010)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
2757890|NCT00820755|Secondary|Percentage of Participants With Disease Control for the Whole Study Period|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed best overall response according to IRC assessment in combination therapy phase and radiological assessments (based on RECIST Version 1.0 criteria) in the maintenance therapy phase.|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
2757891|NCT00820755|Secondary|Percentage of Participants With Disease Control in the Combination Therapy Phase|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed BOR according to IRC assessment.|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
2758049|NCT00819247|Secondary|Number of Participants With Normal Prostate-specific Antigen Levels During the Study|The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).|Weeks 12, 24|Per Protocol Population|||participants|||Number
2757892|NCT00820755|Secondary|Percentage of Participant With Best Unconfirmed Tumor Response for the Whole Study Period|The response rate is defined as the percentage of participants having achieved CR and PR as the BOR according to IRC assessment in combination therapy phase and radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) in the maintenance therapy phase. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
2757893|NCT00820755|Secondary|Percentage of Participants With Best Unconfirmed Tumor Response in the Combination Therapy Phase|The response rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the unconfirmed best overall response (BOR) according to centrally reviewed investigator assessments based on an independent review charter (IRC). As per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
2757894|NCT00820755|Secondary|Time to Treatment Failure (From Randomization to Cetuximab Maintenance Regimen Until Death)|Time from randomization in cetuximab maintenance regimen to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of randomization (Day 1 of maintenance therapy) if they received no study drug.|Time from randomization in cetuximab maintenance regimen to treatment failure or last drug intake, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
2757895|NCT00820755|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from trial inclusion to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of inclusion (Day 1) if they received no study drug.|Time from trial inclusion to treatment failure or last drug intake, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
2757896|NCT00820755|Secondary|Overall Survival (OS) Time (From Randomization to Cetuximab Maintenance Regimen Until Death)|The OS time is defined as the time from randomization in cetuximab maintenance regimen to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization in cetuximab maintenance regimen to death or last day known to be alive, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
2757897|NCT00820755|Primary|Overall Survival (OS) Time|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|Intention-to-treat (ITT) maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on computer tomography [CT] or magnetic resonance imaging [MRI] scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
2757898|NCT00820664|Secondary|Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.||4 weeks|||||||
2757899|NCT00820664|Primary|Immunohistochemistry (IHC) Proliferative Effects Measurement|Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.|4 weeks|Though 29 subjects were enrolled, only 20 subjects had biopsy samples that were deemed adequate for Ki-67 immunohistochemical analysis at Week 4.|||Square root of % positive stained cells||95% Confidence Interval|Least Squares Mean
2757900|NCT00820612|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.|5 days|100% completed follow-up|||participants|||Number
2758510|NCT00815659|Secondary|LDL-4 Level After 3 Months of Rosuvastatin Treatment|LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF(Last Observation Carried Forward) LDL-4 levels of participants|||mg/mL||Standard Deviation|Mean
2757902|NCT00820573|Primary|Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks).|The degree of suppression of baseline endogenous glucose production was measured in absolute values and as a percent of basal values at the end of each 6-week therapeutic period. The absolute values obtained in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|power calculations with data from previous similar studies|||mg/kg.min||Standard Error|Mean
2757903|NCT00820573|Secondary|Fasting Plasma Glucose 6 Weeks After Therapy|Basal pasma glucose was determined with the glucose oxidase method after each specific 6 week treatment. The absolute values obtained of basal plasma glucose at the end of each 6-week therapeutic period in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|All 16 participants were analyzed using ANOVA to compare results after each 6 week period of exposure to therapeutic agent(s)|||mg/dl||Standard Error|Mean
2757904|NCT00820573|Primary|Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP).|Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants|6 weeks||||mg/kg.min||Standard Error|Mean
2757905|NCT00820534|Secondary|Size of the Cold Sore|The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.|72 hours||||square mm||95% Confidence Interval|Mean
2757906|NCT00820534|Primary|Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.|Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).|72 hours||||participants|||Number
2757907|NCT00820443|Secondary|Metal Ion Analysis; Unilateral Only; Serum Chromium|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.|||ug/L||Standard Deviation|Mean
2757908|NCT00820443|Secondary|Metal Ion Analysis (Unilateral Only):Serum Cobalt|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.|||ug/L||Standard Deviation|Mean
2757909|NCT00820443|Secondary|WOMAC Raw Total Score|The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months.|||units on a scale||Standard Deviation|Mean
2757910|NCT00820443|Secondary|The Secondary Measures of the UCLA Functional Assessments|"UCLA: University of California LosAngeles Activity Score~UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as no physical activity and 10 defined as regular participation in impact sports. The score is the higher the better."|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months.|||units on a scale (10 points)||Standard Deviation|Mean
2757911|NCT00820443|Primary|Primary Endpoint/Measures: Success at 24 Months|"The patient success definition is measured at the 24 month interval by the following:~Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain.~No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure.~A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure.~The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery"|24 Month|Patients with Harris Hip Score (HHS) of > 80 Because there isn't complete radiographic data,the composite primary outcome is not analyzed at 24 month as in protocol. Only the number of patients who has HHS score greater that 80 is entered.Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 197.|||participants|||Number
2757913|NCT00820248|Primary|Progression-free Survival (PFS) Rate|"The progression event is defined by first event of the following,~Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason~Number of patients with and without progression event will be reported."|6.2 years||||Participants|||Count of Participants
2757914|NCT00820222|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2% of Participants in Either Treatment Arm|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE.|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months).|Safety Population: all participants in the ITT Population who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized|||Participants|||Count of Participants
2757915|NCT00820222|Secondary|Number of Participants Expressing Glucocorticoid Receptor, Phosphatase and Tensin Homolog (PTEN), Phosphatidylinositide 3-kinase (PI3K)/AKT, Protein 53 (P53), Insulin-like Growth Factor-1 (IGF-1), and Genes Involved in Cell Cycle Regulation|Because the study terminated early, pharmacogenetic and biomarker analyses were not performed.|Baseline|ITT Population||||||
2757916|NCT00820222|Secondary|Number of Participants With Qualitative and Quantitative Toxicities|"Qualitative and quantitative toxicities were measured as AEs. See the outcome measure entitled Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2 participants in either treatment arm and the AE module of this results summary for a list of AEs occurring in the study. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment."|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population||||||
2757917|NCT00820222|Secondary|Number of Participants With CNS Progression at Any Time|CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From the time of randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012|M-ITT Population|||participants|||Number
2757918|NCT00820222|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months). Cut-off 11-Jun-2012|ITT Population. Only those participants with CR or PR showing PD or death due to breast cancer were analyzed.|||months||95% Confidence Interval|Median
2757919|NCT00820222|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD [defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions] based on investigator assessment), for at least 24 weeks.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.|||Participants|||Count of Participants
2757920|NCT00820222|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesions or progression of existing bone lesions, even if the participant had no bone lesions present at Baseline. If a bone scan was performed at the time of initial response or near the time of response, the bone scan did not need to be repeated.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.|||Participants|||Count of Participants
2758511|NCT00815659|Secondary|Basal LDL-4 Level|LDL-4 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-4 levels of participants|||mg/mL||Standard Deviation|Mean
2757921|NCT00820222|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From randomization until death due to any cause (average of 10 months). Cut-off 11-Jun-2012|ITT Population|||months||95% Confidence Interval|Median
2757922|NCT00820222|Secondary|Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until the date of documented CNS progression (average of 10 months). Cut-off 11-Jun-2012|M-ITT Population. Only those participants who had no Baseline CNS metastases and who had CNS progression by radiographic confirmation (per Response Evaluation Criteria in Solid Tumors, 1.0: a 20% increase in the sum of the longest diameter [LD] of target lesions or the appearance of >=1 new lesions) were included in this analysis.|||months||Standard Deviation|Mean
2757923|NCT00820222|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered|||months||95% Confidence Interval|Median
2757924|NCT00820222|Primary|Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012|Modified Intent-to-Treat (M-ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered and who had no Baseline CNS metastases per Independent Review Committee (IRC) assessment|||participants|||Number
2757925|NCT00820170|Secondary|Phase II: Exploratory Somatic Gene Mutations Detection in Archived Tumor Samples||2 years|Data were not collected||||||
2757926|NCT00820170|Secondary|Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks)|Phase II participants only|8 weeks|Phase II participants only|||Participants|||Count of Participants
2757927|NCT00820170|Secondary|Median Time To Progression for Phase II Participants||Through study completion, up to 2 years|This objective is specific for the Phase II participants|||months||95% Confidence Interval|Median
2757928|NCT00820170|Secondary|Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2|Tumor biomarker data obtained at baseline and after 2 cycles of treatment (8 weeks), will be performed by enzyme-linked immunosorbent assay. Clinical Benefit is defined as the sum of the percentage of participants who achieved CR, PR and stable disease for > 6 months.|8 weeks|Phase II participants only|||Participants|||Count of Participants
2757929|NCT00820170|Secondary|Median Progression Free Survival for Phase II Participants|Per RECIST criteria, Progression (PD) is defined at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Through study completion, up to 2 years|This objective is specific for the Phase II participants|||months||95% Confidence Interval|Median
2757930|NCT00820170|Secondary|Participant Adverse Events to Measure Safety and Tolerability of Dasatinib When Administered in Combination With Weekly Paclitaxel.|Evaluate adverse events using CTCAE v3|Through study completion, up to 2 years|The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.|||Participants|||Count of Participants
2757931|NCT00820170|Secondary|Median Overall Survival for Phase II Participants|Overall Survival for Phase II Participants|Through study completion, up to 2 years|This objective is specific for the Phase II participants|||months||95% Confidence Interval|Median
2757932|NCT00820170|Primary|Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial.||Through study completion, up to 2 years|The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study. Results and data analysis reflect this.|||Participants|||Count of Participants
2757933|NCT00820170|Primary|Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.||Through completion of Phase I, up to 1 year|15 participants were enrolled for the Phase I portion of the study. These 15 participants determined the MTD for the study.|||mg of dasatinib|||Number
2757934|NCT00820027|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.|Up to 7 days|The analysis population consisted of all randomized patients who received at least one dose of study treatment.|||Percentage of Participants|||Number
2757935|NCT00820027|Secondary|Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)|The difference in average total daily dose of morphine used over Days 1 through 3 between participants treated with etoricoxib (120 mg, 90 mg) or ibuprofen 1800 mg (administered as 600 mg three times daily, every 8 hours) in the treatment of pain following total knee replacement orthopedic surgery was assessed. Opioids taken were converted to mg morphine equivalents according to the following conventions:1 mg morphine sulphate = 1 mg morphine, 1 mg morphine hydrochloride = 1.17 mg morphine. A 5 mg oxycodone tablet = 2.5 mg morphine,12.5 mg meperidine = 1.67 mg morphine.|Days 1-3|All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the placebo arm was not included in this outcome measure.|||milligrams (mg)||95% Confidence Interval|Geometric Least Squares Mean
2757936|NCT00820027|Secondary|Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)|The pain intensity difference was measured at rest over Days 1 through 3 in participants treated with etoricoxib (120 mg, 90 mg) compared to ibuprofen for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to ibuprofen was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints [Pain Intensity Difference (PID) and morphine] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.|Baseline and Days 1-3|All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the placebo arm was not included in this outcome measure.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2757937|NCT00820027|Primary|Percentage of Participants With at Least One Opioid-Related AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Opioid-related AEs include nausea, vomiting, constipation, somnolence, respiratory depression, urinary retention and ileus.|Up to 21 days|The analysis population consisted of all randomized patients who received at least one dose of study treatment.|||Percentage of Participants|||Number
2757938|NCT00820027|Primary|Percentage of Participants With at Least One Hypertension-Related AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.|Up to 21 days|The analysis population consisted of all randomized patients who received at least one dose of study treatment.|||Percentage of Participants|||Number
2757939|NCT00820027|Primary|Percentage of Participants With at Least One Edema-Related AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Edema is swelling caused by excess fluid trapped in body tissues.|Up to 21 days|The analysis population consisted of all randomized patients who received at least one dose of study treatment.|||Percentage of Participants|||Number
2757940|NCT00820027|Primary|Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.|Up to 21 days|The analysis population consisted of all randomized patients who received at least one dose of study treatment.|||Percentage of Participants|||Number
2757941|NCT00820027|Primary|Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)|The average total dose of morphine was assessed when participant received etoricoxib 120 milligram(mg)/90 mg compared to placebo. Opioids taken were converted to mg morphine equivalents according to the following conventions: 1 mg morphine sulphate=1 mg morphine,1 mg morphine hydrochloride=1.17 mg morphine. A 5 mg oxycodone tablet=2.5 mg morphine,12.5 mg meperidine =1.67 mg morphine. Least-squares mean back-transformed; estimate obtained from longitudinal analysis of variance (ANOVA) model on log-transformed morphine dose with terms for baseline pain intensity(moderate or severe),type of anesthesia (spinal, general), treatment, day, and the interaction of day by treatment.|Days 1-3|All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by PCA. Per protocol, the ibuprofen arm was not included in this outcome measure.|||milligrams (mg)||95% Confidence Interval|Geometric Least Squares Mean
2758512|NCT00815659|Secondary|LDL-3 Level After 3 Months of Rosuvastatin Treatment|LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-3 levels of participants|||mg/mL||Standard Deviation|Mean
2757942|NCT00820027|Primary|Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)|The pain intensity difference was measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) compared to placebo for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to placebo was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints [Pain Intensity Difference (PID) and Morphine] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.|Baseline and Days 1-3|All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the ibuprofen arm was not included in this outcome measure.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2757943|NCT00819910|Secondary|Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit|The mean Levels of AST and ALT measured at initial visit (Day 0) and final visit (Week 12) annotated as AST 1, AST 12, and ALT 1 and ALT 12, respectively.|12 weeks from initial visit (day 0) to final visit (12 weeks)||||mg/dl||Standard Deviation|Mean
2757944|NCT00819910|Secondary|Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels|Post-treatment median change in Apo AI, Apo AII and Apo CIII levels reported in mg/dL with Interquartile ranges provided|12 weeks from initial visit (day 0) to final visit (12 weeks)||||% Change||Inter-Quartile Range|Median
2757945|NCT00819910|Secondary|Post-treatment Percent Change in Low-Density Lipoprotein (LDL) Levels|The reported percent change is the difference between LDL levels obtained on initial visit (day 0) and LDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)||||% change||Standard Deviation|Mean
2757946|NCT00819910|Secondary|Post-treatment Percent Change in High-Density Lipoprotein (HDL) Levels|The reported percent change is the difference between HDL levels obtained on initial visit (day 0) and HDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)||||% change||Standard Deviation|Mean
2757947|NCT00819910|Primary|Percent Change in Triglyceride (TG) Levels Post Treatment|The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|Mean percent change post treatment ( unit %). TG was measured using mg/dL units|||% change||Standard Deviation|Mean
2757948|NCT00819832|Primary|Phase 2: Change in CTCB From Baseline to Post-treatment||CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)|||||||
2757949|NCT00819832|Primary|Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)|Increase in number of cancer cells in patient's blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).|Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)|Study terminated by sponsor; No data analysis done on limited amount of data gathered.||||||
2757950|NCT00819793|Secondary|Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)|Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.|Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP|measurements not made in all subjects|||mmHg||Standard Deviation|Mean
2757951|NCT00819793|Primary|Survival|Number of patients alive 30 days after device implantation|30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant||||Participants|||Count of Participants
2757952|NCT00819780|Secondary|Number of Participants With Adverse Events (AEs)|Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.|The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm.|Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6).|||participants|||Number
2757953|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.|||percentage of participants||95% Confidence Interval|Number
2757954|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS|"Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.~Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.|||percentage of participants||95% Confidence Interval|Number
2757955|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS / BRAF|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.|||months||95% Confidence Interval|Median
2757956|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.|||months||95% Confidence Interval|Median
2757957|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.|||months||95% Confidence Interval|Median
2757958|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.|||months||95% Confidence Interval|Median
2757959|NCT00819780|Secondary|Resection Rate|The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set|||percentage of participants||95% Confidence Interval|Number
2757960|NCT00819780|Secondary|Time to Initial Objective Response|For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator's review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders|||months||Inter-Quartile Range|Median
2757961|NCT00819780|Secondary|Time to Disease Progression|Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set|||months||95% Confidence Interval|Median
2757962|NCT00819780|Secondary|Duration of Response|For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders|||months||95% Confidence Interval|Median
2757972|NCT00819741|Secondary|ECG (ElectroCardioGram)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
2757963|NCT00819780|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator's review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.|||percentage of participants||95% Confidence Interval|Number
2757964|NCT00819780|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set|||months||95% Confidence Interval|Median
2757965|NCT00819780|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat (ITT) analysis set (all randomized participants)|||months||95% Confidence Interval|Median
2757966|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. The SBP at rest vs peak HR was recorded at Week 8 (end of active treatment) and Week 8 + 2 days (48-hrs after last dose; 24-hrs after missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Week 8 (Last dose; end of active treatment) and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.|||mmHg||Standard Error|Least Squares Mean
2757967|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8|The difference in resting vs. peak (85% of the maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 (end of active treatment); the change in SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.|||mmHg||Standard Error|Least Squares Mean
2757968|NCT00819767|Primary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug. The Exercise Evaluable Set (EES) included all patients included in the FAS for whom the treadmill test values for SBP at peak were available at baseline and after a missed dose.|||mmHg||Standard Error|Least Squares Mean
2757969|NCT00819741|Secondary|Haematology: Haemoglobin|Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
2757970|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ASAT)|The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
2757971|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ALAT)|The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
2757995|NCT00819637|Secondary|Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups||1 hour|||||||
2757973|NCT00819741|Secondary|Physical Examinations|The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
2757974|NCT00819741|Secondary|Change in Blood Pressure|Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment|Week 0, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||mmHg||Standard Deviation|Mean
2757975|NCT00819741|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-16|Safety analysis set was defined as all randomised and exposed subjects.|||episodes|||Number
2757976|NCT00819741|Secondary|Change in 2-hour Postprandial Serum C-peptide|Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||ng/ml||Standard Error|Least Squares Mean
2757977|NCT00819741|Secondary|Change in Fasting Serum C-peptide|Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||ng/ml||Standard Error|Least Squares Mean
2757978|NCT00819741|Secondary|Change in 2-hour Postprandial Serum Insulin|Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||mU/L||Standard Error|Least Squares Mean
2757979|NCT00819741|Secondary|Change in Fasting Serum Insulin|Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||mU/L||Standard Error|Least Squares Mean
2757980|NCT00819741|Secondary|Change in 7-point Plasma Glucose Profile|Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
2757981|NCT00819741|Secondary|Change in 2-hour Postprandial Plasma Glucose|Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
2757982|NCT00819741|Secondary|Change in Fasting Plasma Glucose|Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
2757983|NCT00819741|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.|week -2 (screening), week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
2757984|NCT00819637|Secondary|Pharmacokinetics of Arformoterol in This Clinical Setting||5 hours|||||||
2757985|NCT00819637|Secondary|All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles||5 hours|||||||
2757986|NCT00819637|Secondary|Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments|2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.|5 hours|||||||
2757987|NCT00819637|Secondary|Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)|The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.|5 hours|||||||
2757988|NCT00819637|Secondary|The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)||5 hours|||||||
2757989|NCT00819637|Secondary|The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This||5 hour|||||||
2757990|NCT00819637|Secondary|The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour|||||||
2757991|NCT00819637|Secondary|The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour|||||||
2757992|NCT00819637|Secondary|The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour|||||||
2757993|NCT00819637|Primary|The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug||1 hour|As the study was terminated with 2 subjects enrolled, those 2 subjects were used for the limited statistical analysis.|||percent change||95% Confidence Interval|Median
2757994|NCT00819637|Secondary|Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.||5 hours|||||||
2757996|NCT00819585|Secondary|Extension Study: Amount of Rescue Medication Taken|The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||mg||Standard Deviation|Mean
2757997|NCT00819585|Secondary|Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare|"Tenderness was rated on a 0-3 point scale: 0=no pain, 1=patient states that there is pain, 2=patient states there is pain and winces, and 3=patient states there is pain, winces and withdraws on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=no swelling, 1=palpable, 2=visible, and 3=bulging beyond the joint margins. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits."|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Participants|||Number
2757998|NCT00819585|Secondary|Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale|The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Participants|||Number
2757999|NCT00819585|Secondary|Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale|Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Participants|||Number
2758000|NCT00819585|Secondary|Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare|Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose|Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Units on a scale||Standard Deviation|Mean
2758001|NCT00819585|Secondary|Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale|The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.|Days 15, 29, 57, 85, 113, and 141 of the core study|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Participants|||Number
2758002|NCT00819585|Primary|Core Study: Mean Number of Gout Flares Per Participant|A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Gout flares||Standard Deviation|Mean
2758003|NCT00819585|Secondary|Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares|Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
2758004|NCT00819585|Secondary|Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares|Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
2758005|NCT00819585|Secondary|Core Study: Percentage of Participants With Gout Flare at Different Time Points|A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.|Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Percentage of participants||95% Confidence Interval|Number
2758006|NCT00819585|Secondary|Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization|The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Percentage of participants|||Number
2758007|NCT00819585|Secondary|Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab||up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||gout flares per patient||Standard Error|Least Squares Mean
2758008|NCT00819507|Secondary|Change in Transepidermal Water Loss|A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).|2 weeks||||G/m^2/hr||Standard Deviation|Mean
2758009|NCT00819507|Primary|Change in Eczema Severity and Area Index|The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.|2 Weeks||||units||Standard Deviation|Mean
2758010|NCT00819403|Secondary|Biomarkers of Inflammation||6 weeks||||mg/dl||Standard Deviation|Mean
2758011|NCT00819403|Primary|Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression|Measured using whole blood flow cytometry|6 weeks|Based on power calculations|||ng/dl||Standard Deviation|Mean
2758012|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24|Results reported are the week 24 percent activation levels of pDC and mDC.|At week 24|Analysis is based on all participants with assay data at week 24.|||percentage of cells||Inter-Quartile Range|Median
2758013|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12|Results reported are the week 12 percent activation levels of pDC and mDC.|At week 12|Analysis is based on all participants with assay data at week 12.|||percentage of cells||Inter-Quartile Range|Median
2758014|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline|Baseline percent activation levels of pDC were computed as the mean of pre-entry and entry percent activation levels of pDC. Similarly, baseline percent activation levels of mDC were computed as the mean of pre-entry and entry percent activation levels of mDC.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||percentage of cells||Inter-Quartile Range|Median
2758015|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 24|Results reported are the week 24 fasting LPS.|At week 24|Analysis is based on all participants with assay data at week 24.|||pg/mL||Inter-Quartile Range|Median
2758016|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 12|Results reported are the week 12 fasting LPS.|At week 12|Analysis is based on all participants with assay data at week 12.|||pg/mL||Inter-Quartile Range|Median
2758017|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Entry|Results reported are for entry fasting LPS.|At entry|Analysis is based on all participants with assay data at entry.|||pg/mL||Inter-Quartile Range|Median
2758018|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 24|Results reported are the week 24 sCD14.|At week 24|Analysis is based on all participants with assay data at week 24.|||million pg/mL||Inter-Quartile Range|Median
2758019|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 12|Results reported are the week 12 sCD14.|At week 12|Analysis is based on all participants with assay data at week 12.|||million pg/mL||Inter-Quartile Range|Median
2758020|NCT00819390|Secondary|Soluble CD14 (sCD14) at Baseline|Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||million pg/mL||Inter-Quartile Range|Median
2758021|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24|Results reported are the week 24 IL-6, sTNF-rI and D-dimer.|At week 24|Analysis is based on all participants with assay data at week 24.|||pg/mL||Inter-Quartile Range|Median
2758022|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12|Results reported are the week 12 IL-6, sTNF-rI and D-dimer.|At week 12|Analysis is based on all participants with assay data at week 12.|||pg/mL||Inter-Quartile Range|Median
2758023|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline|Baseline IL-6, sTNF-rI and D-dimer were computed as the mean of pre-entry and entry IL-6, sTNF-rI and D-dimer, respectively.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||pg/mL||Inter-Quartile Range|Median
2758024|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 24|Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.|||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758025|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 12|Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.|||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758026|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Baseline|Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758027|NCT00819390|Secondary|Percent CD8 CD38+ at Week 24|Results reported are the week 24 percentage of CD8 expressing CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.|||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
2758028|NCT00819390|Secondary|Percent CD8 CD38+ at Week 12|Results reported are the week 12 percentage of CD8 expressing CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.|||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
2758035|NCT00819390|Secondary|Number of Participants With Events Grade 3 or Higher|Events included signs and symptoms, laboratory abnormalities and/or clinical events grade 3 or higher which were described by site clinician blinded to the treatment arm as definitely or possibly related to the study treatment.|From start of study treatment to study completion at week 28|Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.|||participants|||Number
2758036|NCT00819390|Secondary|Change in Total CD4 T Cell Count From Baseline to Week 12|Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||cells/mm^3||Inter-Quartile Range|Median
2758037|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|At Pre-entry, entry, Weeks 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758038|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24|The mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ is subtracted from the mean of the week 22 and week 24 percent CD8 HLA-DR+/CD38+|At Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at weeks 10 or 12, and 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758039|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period|For Arm A: Chloroquine then Placebo for off-ART participants and Arm C: Chloroquine then Placebo for on-ART participants, the baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+. For Arm B: Placebo then Chloroquine for off-ART participants and Arm D: Placebo then Chloroquine for on-ART participants, the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at the required time points, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758040|NCT00819390|Primary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
2758041|NCT00819286|Primary|Activity Based Total Visual Analog Pain Score|"Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an Activity Based Total Visual Analog Pain Score, (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated."|6 months|All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.|||units on a scale||Standard Deviation|Mean
2758042|NCT00819286|Primary|CT Scan Evaluation of Sternal Bone Healing|Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)|3 and 6 Months|Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.|||units on a scale||Standard Deviation|Mean
2758043|NCT00819260|Secondary|Hematoma|A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.|first day after surgery|entire study population|||participants|||Number
2758044|NCT00819260|Secondary|Pain Level in Surgical Sites|An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.|first week after surgery|all study participants|||units on a scale||Standard Deviation|Median
2758045|NCT00819260|Secondary|Volume of Drainage in Surgical Drains|An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.|within one week of surgery|All participants in the study.|||mL/hour||Standard Deviation|Median
2758046|NCT00819260|Primary|Time for Operation|Time to complete the breast reduction per breast.|day of surgery|Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.|||minutes||Standard Deviation|Median
2758047|NCT00819247|Secondary|Percentage Change in Vital Signs and Body Weight|Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.|Baseline and Six months|Safety population.|||percentage||Full Range|Median
2758048|NCT00819247|Secondary|The Number of Participants With Abnormal Liver Function Tests|The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.|Six months|Randomized (Safety) population|||participants|||Number
2758050|NCT00819247|Secondary|Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen|Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.|Six months|per protocol population|||participants|||Number
2758051|NCT00819247|Secondary|Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24|Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.|Weeks 4-24|Per protocol population|||participants|||Number
2758052|NCT00819247|Secondary|Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24||Weeks 4-24|Per protocol population|||participants|||Number
2758053|NCT00819247|Primary|Number of Participants With Testosterone <0.5 Nanogram/Milliliter||Weeks 1,2,4,8,12,16,20,24|Per protocol population|||participants|||Number
2758054|NCT00819234|Secondary|Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to end of treatment follow up|N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8.|||participants|||Number
2758055|NCT00819234|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population|Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a|Baseline to Week 52|All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37.|||Number of Laboratory values|||Number
2758056|NCT00819234|Secondary|Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population|Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urinalysis: Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12);|||number of laboratory values|||Number
2758057|NCT00819234|Secondary|Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 52|Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52.|||msec||Standard Deviation|Mean
2758058|NCT00819234|Secondary|Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.|||bpm||Standard Deviation|Mean
2758059|NCT00819234|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).|Baseline (Day 1) to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.|||mm Hg||Standard Deviation|Mean
2758072|NCT00819234|Secondary|LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).|Original baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||kg||95% Confidence Interval|Least Squares Mean
2758060|NCT00819234|Secondary|Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.|Baseline to end of treatment follow up|number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68)|||ng/mL||Standard Error|Geometric Mean
2758061|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - Week 52 Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
2758062|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores - Week 52 Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
2758063|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
2758064|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
2758065|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population|Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Week 28) to Week 52|Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.|||participants|||Number
2758092|NCT00819156|Secondary|Days to 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population|||days||Full Range|Median
2758093|NCT00819156|Secondary|Days to 50 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population|||days||Full Range|Median
2758066|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population|Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Day 1) to Week 52|Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.|||participants|||Number
2758067|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population|Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E.|||µIU/mL||95% Confidence Interval|Least Squares Mean
2758068|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population|Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline (Day 1) to Week 52|n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E.|||mg/dL||95% Confidence Interval|Least Squares Mean
2758069|NCT00819234|Secondary|LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population|Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.|||Percentage of change in weight||95% Confidence Interval|Least Squares Mean
2758070|NCT00819234|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population|Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|Baseline to Week 52|n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.|||cm||95% Confidence Interval|Least Squares Mean
2758071|NCT00819234|Secondary|Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population|Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.|Original Study Baseline to Extension Week 52 and follow up|Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.|||ng/mL||Standard Error|Geometric Mean
2758094|NCT00819156|Secondary|Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.|Day 3|ITT population.|||participants|||Number
2758095|NCT00819156|Secondary|Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.|Day 28|ITT population.|||participants|||Number
2758588|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.|24 Months|Intention-to-Treat (ITT)|||percentage of participants|Participants||Number
2758073|NCT00819234|Primary|LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.|Original Study Baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||percentage of change in weight||95% Confidence Interval|Least Squares Mean
2758074|NCT00819182|Other Pre-specified|Intervention Adherence|Number of breathing practice sessions per participant over the 16 week study period.|16 weeks||||Total practice sessions in 16 weeks||Standard Deviation|Mean
2758075|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.|16 weeks||||Breaths Per Minute||Standard Deviation|Mean
2758076|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.|2 weeks||||Breaths Per Minute||Standard Deviation|Mean
2758077|NCT00819182|Primary|Hot Flash Bother|Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
2758078|NCT00819182|Primary|Hot Flash Severity|Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
2758079|NCT00819182|Secondary|Sleep Disturbance|Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.|16 weeks||||Global Sleep Disturbance Score||Standard Deviation|Mean
2758080|NCT00819182|Secondary|Mood Disturbance|Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.|16 weeks||||Scores on a scale||Standard Deviation|Mean
2758081|NCT00819182|Secondary|Perceived Control Over Hot Flashes|Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
2758082|NCT00819182|Secondary|Hot Flash Related Daily Interference|Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
2758083|NCT00819182|Primary|Hot Flash Frequency|Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.|16 weeks|Analysis based on all randomized participants.|||Hot flashes per 24 hr||Standard Deviation|Mean
2758084|NCT00819156|Secondary|The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population|||participants|||Number
2758085|NCT00819156|Secondary|The Number of Patients With Abnormal Liver Function Tests|The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.|364 days|ITT population|||participants|||Number
2758086|NCT00819156|Secondary|Median Values for Follicle Stimulation Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population|||international units / liter||Full Range|Median
2758087|NCT00819156|Secondary|Median Values for Serum Luteinizing Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population|||international units / liter||Full Range|Median
2758088|NCT00819156|Secondary|Median Values of Di-Hydrotestosterone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population|||picogram / milliliter||Full Range|Median
2758089|NCT00819156|Secondary|Median Prostate-specific Antigen Levels||Day 0 (Baseline), Days 3, 7, 14, and 364|ITT population|||nanogram / milliliter||Full Range|Median
2758090|NCT00819156|Secondary|Median Serum Testosterone Levels||Day 0 (Baseline), Days 1,3,7,14, and 364|ITT population|||nanogram/milliliter||Full Range|Median
2758091|NCT00819156|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.|Day 0 (post dose) to Day 364|Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.|||days||Full Range|Median
2758096|NCT00819156|Secondary|Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28|Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.|Day 28 - 364|ITT population of patients with testoterone measurements <=0.5 nanogram/milliliter at Day 28.|||participants|||Number
2758097|NCT00819156|Primary|Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364|Number of patients who achieved a testosterone level considered a castration level.|12 months|ITT population.|||participants|||Number
2758098|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2758099|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 6|Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 6|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2758100|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).|||percent||Standard Error|Least Squares Mean
2758101|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 12|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).|||percent||Standard Error|Least Squares Mean
2758102|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6|HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 6|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).|||percent||Standard Error|Least Squares Mean
2758103|NCT00819091|Secondary|Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18|An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.|Baseline, week 18|FAS patients. Non-completers were considered as failure imputation (NCF).|||percentage of participants|||Number
2758104|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18|An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of participants|||Number
2758105|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18|An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||Percentage of Patients|||Number
2758106|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 18|Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2758107|NCT00819091|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Least Squares Mean
2758108|NCT00819052|Secondary|Trough Plasma Concentration|Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).|Day 1 to week 48|All patients with evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2758109|NCT00819052|Secondary|Genotypic Resistance Associated With Virologic Failure|"Genotypic resistance associated with virologic failure.~This endpoint was not analysed due to lack of data."|48 weeks|All patients in the treated set who experienced virologic failure.||||||
2758110|NCT00819052|Secondary|Time to Loss of Virologic Response|Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.|48 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||days||95% Confidence Interval|Median
2758111|NCT00819052|Secondary|New AIDS or AIDS-related Progression Event or Death||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
2758112|NCT00819052|Secondary|Occurence of Hepatic Events||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
2758113|NCT00819052|Secondary|Occurence of Rashes|drug-related rashes by severity|144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
2758114|NCT00819052|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of investigations related to treatment|until week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
2758115|NCT00819052|Secondary|Change From Baseline in VL (HIV-1 Viral Load) at Each Visit||week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases.|||copies/mL||Standard Deviation|Mean
2758116|NCT00819052|Secondary|Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144.|||participants|||Number
2758117|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population||baseline, last available visit (up to 144 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks).|||cells/cubic millimeter||Standard Deviation|Mean
2758118|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144.|||cells/cubic millimeter||Standard Deviation|Mean
2758119|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population||baseline, week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132.|||cells/cubic millimeter||Standard Deviation|Mean
2758120|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population||baseline, week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120.|||cells/cubic millimeter||Standard Deviation|Mean
2758121|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population||baseline, week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108.|||cells/cubic millimeter||Standard Deviation|Mean
2758122|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population||baseline, week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96.|||cells/cubic millimeter||Standard Deviation|Mean
2758123|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population||baseline, week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84.|||cells/cubic millimeter||Standard Deviation|Mean
2758124|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population||baseline, week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72.|||cells/cubic millimeter||Standard Deviation|Mean
2758125|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population||baseline, week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60.|||cells/cubic millimeter||Standard Deviation|Mean
2758126|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population||baseline, week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48.|||cells/cubic millimeter||Standard Deviation|Mean
2758127|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response at their last available visit|last available visit, up to 144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks).|||participants|||Number
2758128|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144.|||participants|||Number
2758129|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 132|week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132.|||participants|||Number
2758130|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 120|week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120.|||participants|||Number
2761507|NCT00795951|Primary|Diagnostic Performance: Tixocortol-21-pivalate|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2758131|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 108|week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108.|||participants|||Number
2758132|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 96|week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96.|||participants|||Number
2758133|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 84|week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84.|||participants|||Number
2758134|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 72|week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72.|||participants|||Number
2758135|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 60|week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60.|||participants|||Number
2758136|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 48|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48.|||participants|||Number
2758137|NCT00819052|Secondary|Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24.|||cells/cubic millimeter||Standard Error|Least Squares Mean
2758138|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24.|||cells/cubic millimeter||Standard Deviation|Mean
2758139|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population||baseline, week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12.|||cells/cubic millimeter||Standard Deviation|Mean
2758140|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population||baseline, week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8.|||cells/cubic millimeter||Standard Deviation|Mean
2758141|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population||baseline, week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4.|||cells/cubic millimeter||Standard Deviation|Mean
2758142|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population||baseline, week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2.|||cells/cubic millimeter||Standard Deviation|Mean
2758143|NCT00819052|Secondary|Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population||week 0|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline.|||cells/cubic millimeter||Standard Deviation|Mean
2758144|NCT00819052|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||proportion of participants|||Number
2758145|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
2758146|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 12|week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
2758626|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy||from start of intubation to successfully intubated||||seconds||Inter-Quartile Range|Median
2758147|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 8|week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
2758148|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 4|week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
2758149|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 2|week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
2758150|NCT00819052|Primary|Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
2758151|NCT00819039|Secondary|Number of Participants With Vomiting Frequency in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
2758152|NCT00819039|Secondary|Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.|Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
2758153|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2||Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
2758154|NCT00819039|Secondary|Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.|Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
2758155|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
2758156|NCT00819039|Primary|Number of Participants Discontinuing Study Treatment Due to AEs||Day 1|The population consists of all participants that received at least one dose of study medication.|||Participants|||Number
2758157|NCT00819039|Primary|Number of Participants Experiencing Adverse Events (AEs)||Up to 21 Days Post-Surgery|The population consists of all participants that received at least one dose of study medication.|||Participants|||Number
2758158|NCT00819039|Primary|Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1|The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available.|||ng/mL||Standard Deviation|Mean
2758159|NCT00819039|Primary|Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ).|24 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available.|||ng/mL||Standard Deviation|Mean
2758160|NCT00819039|Primary|Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available.|||Hours||Full Range|Median
2758161|NCT00819039|Primary|Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available.|||ng/mL||Standard Deviation|Mean
2758162|NCT00819039|Primary|Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.|Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose|The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available.|||hr*ug/ml||Standard Deviation|Mean
2758163|NCT00819013|Secondary|Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.~Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods"|Day 0 and Day 15 through Month 10 Post-vaccination 1|Seropositivity to Hepatitis B core antigen was assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||Participants|||Number
2758164|NCT00819013|Secondary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 15 through Month 10 post-vaccination 1|Antibody responses were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.|||1/diultion (1/dil)||95% Confidence Interval|Geometric Mean
2758165|NCT00819013|Secondary|Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2758166|NCT00819013|Secondary|Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).~A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)."|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
2758167|NCT00819013|Secondary|Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 60 Post-vaccination 1|Seroconversion to M2e antigens were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||Participants|||Number
2758168|NCT00819013|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.|"Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).~A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)"|Day 15 through Month 10 Post-vaccination 1|Geometric mean titers of the respective vaccine antibodies were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population; per-protocol population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
2758169|NCT00819013|Primary|Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine|Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 15 through Month 10 Post-vaccination 1|Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.|||Participants|||Number
2758170|NCT00819013|Secondary|Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.|Month 4 through Month 10 post-vaccination 1|Influenza signs and symptoms were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.|||Participants|||Number
2758171|NCT00819013|Primary|Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.||Day 0 through Day 60 post-vaccination 1|Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).|||Participants|||Number
2758172|NCT00819013|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.|Day 0 through Day 7 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.|||Participants|||Number
2758173|NCT00819013|Primary|Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.||Day 0 through Day 60 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.|||Participants|||Number
2758174|NCT00818961|Secondary|Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant|Patients will be evaluated up to 4 years post transplant|4 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of VOD post-transplant|||participants|||Number
2758175|NCT00818961|Secondary|Number of Patients Experiencing Chronic Graft Versus Host Disease||>100 days post-transplant|35 patients survive past 100 days post-transplant and therefore were eligible for evaluation of chronic graft versus host disease|||participants|||Number
2758176|NCT00818961|Secondary|Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant|patients experiencing acute graft versus host disease post-transplant|patients were followed for 2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of acute graft versus host disease post-transplant.|||participants|||Number
2758177|NCT00818961|Secondary|Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism|DLI is used for patients with mixed chimerism following transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for donor leukocyte infusions for mixed chimerism following transplant|||participants|||Number
2758178|NCT00818961|Secondary|Platelet Engraftment|The number of patients experiencing platelet engraftment post-transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of platelet engraftment.|||participants|||Number
2758179|NCT00818961|Secondary|Neutrophil Recovery|The number of patients experiencing neutrophil recovery post transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of neutrophil recovery|||participants|||Number
2758180|NCT00818961|Secondary|Complete Donor Chimerism|Complete donor chimerism (defined as >/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured.|2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of donor chimerism|||participants|||Number
2758181|NCT00818961|Secondary|Non-relapse Mortality at 1 Year Post-transplant|Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive.|1 year|36 patients underwent hematopoietic stem cell transplant. 10 patients died prior to 1 year post-transplant and were eligible for evaluation of non-relapse mortality at 1 year post-transplant|||participants|||Number
2758182|NCT00818961|Secondary|Non-relapse Mortality at Day 100|patients are evaluable for their cause of death at Day 100|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of non-relapse mortality at Day 100|||participants|||Number
2758183|NCT00818961|Secondary|Overall Survival at 1 Year|Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant)|1 year|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at one year post-transplant|||participants|||Number
2758184|NCT00818961|Primary|Survival at Day 100|Survival at Day 100|100 day|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at 100 days|||participants|||Number
2758185|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at each week indicated, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease or <130/80 mm Hg for participants with diabetes or chronic kidney disease[GFR <60 mL/min/1.73 m2 or urinary albumin:creatinine ratio (UACR) >200 mg albumin/g creatinine at Screening.] Systolic/diastolic blood pressure is the average of the 3 serial trough sitting systolic/diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||percentage of participants|||Number
2758186|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as <90 mm Hg for participants without diabetes or chronic kidney disease or <80 mm Hg for participants with diabetes or chronic kidney disease. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||percentage of participants|||Number
2758187|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as <140mm Hg without diabetes or chronic kidney disease or <130/mm Hg with diabetes or chronic kidney disease. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||percentage of participants|||Number
2758188|NCT00818883|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758251|NCT00818649|Secondary|Correlative Laboratory Studies|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing|Pre-Study and After 3 Cycles|Natural Killer cell studies were discontinued after the first 3 patients because the results were not helpful, and thus the secondary outcome measures were not completed.||||||
2758189|NCT00818883|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758190|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758191|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758192|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758193|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758194|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758195|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758196|NCT00818883|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758197|NCT00818883|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758198|NCT00818883|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758199|NCT00818883|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure|The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2758200|NCT00818805|Secondary|Change in Total Score in Ocular Symptom Questionnaire||15-180 min.|||||||
2758201|NCT00818805|Primary|"Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire"|Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.|0-180 minutes after entering the examination room||||Units on a scale||Standard Deviation|Mean
2758202|NCT00818779|Secondary|Serum Level of Nitric Oxide|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)||||mmmol/l||95% Confidence Interval|Mean
2758203|NCT00818779|Secondary|Serum Level of C-reactive Protein|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)||||mg/l||95% Confidence Interval|Mean
2758204|NCT00818779|Secondary|Serum Level of Intracellular Cell Adhesion Molecule|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)||||ng/ml||95% Confidence Interval|Mean
2758205|NCT00818779|Secondary|Serum Level of Vascular Cell Adhesion Molecule|Surrogate biomarker cardiovascular risk|6 week (change from baseline)||||ng/ml||95% Confidence Interval|Mean
2758206|NCT00818779|Primary|Plasminogen Activator Inhibitor 1|Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.|6 weeks (change from baseline)||||ng/ml||95% Confidence Interval|Mean
2758207|NCT00818766|Secondary|All-Cause Mortality|All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758208|NCT00818766|Secondary|Number of Participants With Allergic Reactions|The number of participants with an allergic reaction to a drug.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758209|NCT00818766|Secondary|Time to Removal of Chest Tubes|Time to removal of chest tubes is the number of days from the time of chest tube placement to time they were removed.|From day of surgery to removal of chest tubes (up to 33 days)|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||days||Full Range|Median
2758210|NCT00818766|Secondary|Length of Hospital Stay|The length of hospital stay is the number of days the participant remained in the hospital.|From day of surgery to discharge (up to 35 days)|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||days||Full Range|Median
2758211|NCT00818766|Secondary|Number of Participants Who Needed Reoperation|The number of participants who needed reoperations for any reason from the time after the first surgery to the end of the 28-day follow-up period.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758212|NCT00818766|Secondary|Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery|The number of participants who needed any additional non-study antibiotics for any reason after randomization.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758213|NCT00818766|Primary|Number of Participants Who Experienced Clostridium (C) Difficile Colitis|"C. Difficile Colitis:~Positive for C difficile toxin assay results and any 1 of the following:~new diarrhea~ileus or toxic megacolon~leukopenia (WBC count of <4000/µL) or leukocytosis (WBC count of >11000/µL)~findings from sigmoidoscopy, colonoscopy, or histopathologic examination consistent with C difficile infection"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758214|NCT00818766|Primary|Number of Participants Who Experienced Empyema|"Empyema:~Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (>38°C)."|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758215|NCT00818766|Primary|Number of Participants Who Experienced Pneumonia|"Pneumonia:~A new infiltrate on chest x-ray associated with at least three of the following:~fever (>38°C)~purulent sputum~leukopenia (white blood cell [WBC] count of <4000/µL) or leukocytosis (WBC count of >11000/µL)~sputum culture with pathogenic bacteria~increased oxygen requirements"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758216|NCT00818766|Primary|Number of Participants Who Experienced Surgical Site Infection|"Surgical Site Infection:~Superficial surgical site infection - involves only skin or subcutaneous tissue around incision and has at least one of the following criteria:~purulent drainage~organisms isolated from aseptically obtained culture~pain or tenderness, localized swelling, redness or heat and the incision deliberately opened by a surgeon~diagnosis of a superficial wound infection by a surgeon~Deep surgical site infection - involves deep soft tissues e.g. fascia or muscle and has at least one of the following:~purulent drainage from the incision but not from the organ/space of the surgical site~deep incision spontaneously dehisces or deliberately opened by surgeon when patient has at least one of following signs or symptoms - fever (>38°C), localized pain or tenderness.~an abscess or evidence of infection involving incision is found on direct examination, histopathologic or radiographic examination~diagnosis of a deep wound infection"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758217|NCT00818766|Primary|Number of Participants Who Experienced At Least One Postoperative Infectious Complication|Infectious complications include: surgical site infection, empyema, pneumonia, and the occurrence of Clostridium difficile colitis within 28 days of surgery. Participants are only counted once regardless of how many different infectious complications they had.|Up to 28 days after surgery|Intent-to-Treat (ITT) Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
2758218|NCT00818753|Secondary|Number of Participants With Bleeding Events|Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first).|First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)|Treated set. All randomised patients who were documented to have taken at least 1 dose of study drug.|||participants|||Number
2758219|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
2758220|NCT00818753|Secondary|Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
2758221|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
2758222|NCT00818753|Primary|Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
2758223|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Rash|Participants requiring systemic therapy or discontinuation from further treatment|Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
2758224|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits||Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
2758225|NCT00818662|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)||Throughout each infusion period|Safety Analysis Set|||Adverse events|Infusions||Number
2758226|NCT00818662|Secondary|Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered|Throughout the study period, approximately 4 years|Safety Analysis Set|||Infusions|Infusions||Number
2758227|NCT00818662|Secondary|Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)|During or within 72 hours of completion of an infusion|Safety Analysis Set|||Infusions|Infusions||Number
2758228|NCT00818662|Secondary|Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class|Related and unrelated SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
2758229|NCT00818662|Secondary|Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class|Related and unrelated non-SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
2758230|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
2758231|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
2761508|NCT00795951|Primary|Diagnostic Performance: Budesonide|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2758232|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test|In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to 'ten after eleven.' Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758233|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||seconds||Standard Deviation|Mean
2758234|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||seconds||Standard Deviation|Mean
2758235|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency|"In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category animals as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment."|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
2758236|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution|WAIS-R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
2758237|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency|In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as 'acts,' 'acted,' 'acting'). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
2758238|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
2758239|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
2758240|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758241|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758242|NCT00818662|Secondary|Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758243|NCT00818662|Secondary|Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination|The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758244|NCT00818662|Secondary|Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.~A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).~Very much better~Much better~A little better~Same~A little worse~Much worse~Very much worse"|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||participants|||Number
2758245|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.~A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).~Very much better~Much better~A little better~Same~A little worse~Much worse~Very much worse"|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.|||participants|||Number
2758246|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.|||Scores on a scale||Standard Deviation|Mean
2758247|NCT00818662|Secondary|Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 9 months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.|||Scores on a scale||Standard Deviation|Mean
2758248|NCT00818662|Primary|Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758249|NCT00818662|Primary|Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
2758250|NCT00818649|Secondary|Correlation of Cell Alterations With Clinical Response|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing|Pre-Study and After 3 Cycles|Natural Killer cell studies were discontinued after the first 3 patients because the results were not helpful. So, secondary outcome measures were not completed.||||||
2758516|NCT00815659|Secondary|Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment|TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants|||pg/mL||Standard Deviation|Mean
2758252|NCT00818649|Primary|Number of Patients by Best Clinical Response|Assessed by the International Working Group response criteria: Complete Remission - <5% myeloblasts with normal maturation of all cell lines; Partial Remission - bone marrow blasts decreased by > 50% over pre-treatment but still >5%; and Hematologic Improvement - hemoglobin increase by > 1.5g/dl or decreased transfusions by at least 4/8 week period, platelet absolute increase of >30 X 10^9/L for those starting at >20 X 10^9/L . For those < 20 X 10^9 /L at baseline increase by 100%.|At Completion of Course 3 (Day 63)|Evaluable patients are defined as those who completed at least 1 cycle of therapy; 8 had acute myeloid leukemia, 4 had myelodysplastic syndrome.|||Patients|||Number
2758253|NCT00818623|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.|||participants|||Number
2758254|NCT00818623|Secondary|Evaluation of Liver Function Tests|The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months||||participants|||Number
2758255|NCT00818623|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.|||days||Full Range|Median
2758256|NCT00818623|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.|||days||Full Range|Median
2758257|NCT00818623|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.|3 months|ITT population|||days||Full Range|Median
2758258|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.|3 months|ITT population.|||participants|||Number
2758259|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.|Two - six months|ITT population.|||participants|||Number
2758260|NCT00818623|Primary|Time From Dosing Until Testosterone Levels >0.5 ng/mL|Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.|3 months|ITT population.|||days||95% Confidence Interval|Median
2758261|NCT00818519|Secondary|"Percentage of Participants Classified as Improved According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating"|"The proportion of participants rated as improved comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator's Overall Improvement Rating and those with excellent, good, or fair improvement the Participant's Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise not improved status."|At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)|FAS (due to missing data number of participants differs from number at Baseline)|||Percentage of participants|||Number
2758262|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones|Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
2758263|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones|Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
2758264|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules|Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
2758265|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules|Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
2758266|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Papules|Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
2758267|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
2758268|NCT00818519|Secondary|"Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6"|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 6 (Day 15±3 days of Treatment Cycle 6)|FAS, all participants with data for Cycle 6|||Percentage of participants|||Number
2758269|NCT00818519|Secondary|"Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3"|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 3 (Day 15±3 days of Treatment Cycle 3)|FAS, all participants with data for Cycle 3|||Percentage of participants|||Number
2758270|NCT00818519|Secondary|"Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1"|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 1 (Day 15±3 days of Treatment Cycle 1)|FAS, all participants with data for Cycle 1|||Percentage of participants|||Number
2758271|NCT00818519|Secondary|"Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit"|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Screening visit|Full analysis set at screening|||Percentage of participants|||Number
2758272|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|PPS|||Percent change||Standard Deviation|Mean
2758273|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS|||Percent change||Standard Deviation|Mean
2758274|NCT00818454|Secondary|Peak FEV1 Response|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.|||liters||Standard Error|Least Squares Mean
2758275|NCT00818454|Secondary|FEV1 AUC0-6 Response (Parallel Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under the Curve from 0 to 6 hours|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.|||liters||Standard Error|Least Squares Mean
2758276|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
2758277|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
2758278|NCT00818454|Secondary|Puffs Study Medication Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
2758279|NCT00818454|Secondary|Puffs Study Medication Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
2758280|NCT00818454|Secondary|Asthma Control Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in ACQ score. Worst score - 6(most severe), best score - 0 (no symptoms)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Scores on scale||Standard Error|Least Squares Mean
2758281|NCT00818454|Secondary|Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in Mini-AQLQ score. Worst score - 1 (most severe), best score - 7 (less severe)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Scores on scale||Standard Error|Least Squares Mean
2758282|NCT00818454|Primary|Peak FEV1 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||liters||Standard Error|Least Squares Mean
2758283|NCT00818454|Primary|FEV1 AUC0-6 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||liters||Standard Error|Least Squares Mean
2758284|NCT00818441|Secondary|Trough Plasma Concentrations (Ctrough) of Dacomitinib|Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).|Predose on C1D14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis set: all participants who received at least 1 dose of study medication at selected PK sites from whom at least 1 PK sample were obtained. 'N' (number of participants analyzed) = participants who were evaluable for this measure at any time point. n = participants evaluable at given time points for specified dose.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2758285|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.|Baseline (C1D1) up to C75|PRO analysis set: participants who received >=1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. n=participants evaluable at specified time points for given parameter.|||number of participants|||Number
2758294|NCT00818389|Primary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.|9 months: Baseline to study termination (January 2009 - October 2009)||||Participants|||Number
2758286|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.|Baseline (Cycle [C]1 Day 1), up to C75|Patient reported Outcome (PRO) analysis set:participants who received at least (>=) 1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. 'N' (number of participants analyzed)=participants evaluable for this measure.n=participants evaluable at specified time points for given parameter.|||number of participants|||Number
2758287|NCT00818441|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Randomization until death or last date known to be alive.|As-enrolled population included all participants who were enrolled in the study.|||months||95% Confidence Interval|Median
2758288|NCT00818441|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|DR was calculated for a subgroup of participants from the response-evaluable population, who had confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
2758289|NCT00818441|Secondary|Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|Response-evaluable population included all enrolled participants who received at least 1 dose of study medication, had an adequate baseline tumor assessment, and had at least 1 on-study tumor assessment after the first dosing.|||participants|||Number
2758290|NCT00818441|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|As-enrolled population included all participants who were enrolled in the study.|||months||95% Confidence Interval|Median
2758291|NCT00818441|Secondary|Progression-Free Survival (PFS) at Month 4: Cohort B|PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4||||percent chance of being event-free||95% Confidence Interval|Number
2758292|NCT00818441|Primary|Progression-Free Survival (PFS) at Month 4: Cohort A|PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4|As-enrolled population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2758293|NCT00818389|Secondary|Vital Capacity (VC) (Percent of Predicted Normal)|Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.|9 months: Baseline to study termination (January 2009- October 2009)||||Percent of predicted normal||Standard Error|Mean
2758370|NCT00817219|Primary|Adverse Drug Reactions|"The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as not related."|Week 4||||participants|||Number
2758295|NCT00818389|Secondary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.|9 months: Baseline to study termination (January 2009 - October 2009)||||Scores on a scale||Standard Error|Mean
2758296|NCT00818337|Secondary|Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg|Aspirin resistance was defined as ARU > 550|2 weeks||||participants|||Number
2758297|NCT00818337|Primary|Number of Women Aspirin Resistant|Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.|Baseline||||participants|||Number
2758298|NCT00818324|Other Pre-specified|Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52||||LGCS score||Standard Deviation|Mean
2758299|NCT00818324|Primary|Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52||||FCS score||Standard Deviation|Mean
2758300|NCT00818272|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~No~Missing"|Baseline||||Participants|||Number
2758301|NCT00818272|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:~Yes~No~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline||||Participants|||Number
2758302|NCT00818272|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:~Yes~No~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline||||Participants|||Number
2758303|NCT00818272|Secondary|Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion|The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first Infusion|Data was analyzed for all CD participants whose data had been entered in the database and finalized by signature of the physician. 90 out of 148 participants available at enrollment completed the CDAI and 42 out of the 128 available participants at first infusion after screening (beginning of 2 year observation period) completed the CDAI.|||Score on a scale||Standard Deviation|Mean
2758304|NCT00818272|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:~Yes~No~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline||||Participants|||Number
2758305|NCT00818259|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.|Day 1 up to Day 3|The ASaT population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2758306|NCT00818259|Secondary|Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age|Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post dexamethasone dose|This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to <6 months of age into Part II was unsuccessful.||||||
2758307|NCT00818259|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.|Up to 14 days after last dose of study drug (Up to 17 days)|The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2758308|NCT00818259|Primary|Tmax for Fosaprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.|||hr||Standard Deviation|Mean
2758309|NCT00818259|Primary|Cmax for Fosaprepitant|Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.|||ng/mL||Standard Deviation|Mean
2758310|NCT00818259|Primary|Apparent Terminal Half-life (t1/2) for Aprepitant|t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||hr||Standard Deviation|Mean
2758311|NCT00818259|Primary|Time to Cmax (Tmax) for Aprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||hr||Standard Deviation|Mean
2758312|NCT00818259|Primary|Maximum Plasma Concentration (Cmax) for Aprepitant|Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||ng/mL||Standard Deviation|Mean
2758313|NCT00818259|Primary|Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant|AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||hr*ng/mL||Standard Deviation|Mean
2758314|NCT00818246|Secondary|Number of Adverse Events.|Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.|Adverse reactions were monitored throughout the study and up to 4 weeks.|Intention to treat (ITT)|||Number of adverse events|||Number
2758315|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Rz values (peak to valley analysis) to quantify rhytid depth and severity.|Baseline and 4 weeks|Per Protocol|||Percent change post-treatment||95% Confidence Interval|Mean
2758517|NCT00815659|Secondary|Basal Tumor Necrosis Factor (TNF) Level|TNF levels before (Visit 2-enrollment)|Baseline|Baseline Basal Tumor Necrosis Factor (TNF) levels of participants|||pg/mL||Standard Deviation|Mean
2758316|NCT00818246|Secondary|Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.|Clinical qualitative assessment was performed by three blinded medical observers through the evaluation of digital photographs. The photographs were analyzed for clinical improvement using the Fitzpatrick Classification System (FCS)subtype scale for degree of wrinkling (rhytids). Their assessment was rated on a five-point scale and scored as follows; 0=none; 1=mild; 2=moderate; 3=good; 4=excellent.|Baseline and 4 weeks|Per Protocol|||Change in units on the FCS scale||95% Confidence Interval|Mean
2758317|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Ra values (skin surface roughness).|Baseline and 4 weeks|Per Protocol|||Percent change post-treatment||95% Confidence Interval|Mean
2758318|NCT00818207|Secondary|Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52|"LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52"|Week 26 to Week 52|ITT|||Percentage of Participants|||Number
2758319|NCT00818207|Secondary|Percentage of Participants With 7-Day PP of Abstinence at Week 13|"PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?"|Week 13|ITT|||Percentage of Participants|||Number
2758320|NCT00818207|Secondary|Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52|"CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions Have you smoked any cigarettes (even a puff) since the last contact/visit? at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit? and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing."|Week 26, Week 39, and Week 52|ITT|||Percentage of Participants|||Number
2758321|NCT00818207|Secondary|Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco|"PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days? confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL])."|Week 26|ITT|||Percentage of Participants|||Number
2758322|NCT00818207|Primary|Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence|"Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"|Week 26|Intent to Treat (ITT) Population: all randomized participants|||Percentage of Participants|||Number
2758323|NCT00818168|Secondary|Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion|The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first infusion|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Units on a scale||Standard Deviation|Mean
2758324|NCT00818168|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~No~Missing"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Participants|||Number
2758325|NCT00818168|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:~Yes~No~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Participants|||Number
2758326|NCT00818168|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:~Yes~No~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Participants|||Number
2758327|NCT00818168|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:~Yes~No~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||participants|||Number
2758328|NCT00818116|Primary|Uncorrected and Best Corrected Visual Acuities (Near and Distance)|"Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|6 Months Following Cataract Surgery||||logMAR||Standard Deviation|Mean
2758329|NCT00817999|Primary|% Platelet Inhibition|% platelet inhibition measured by Verify Now|6 hours||||percentage of platelet inhibition||Standard Deviation|Mean
2758330|NCT00817843|Primary|Treatment Difference in (Postprandial-Fasting) FMD|A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg|After 6 weeks of treatment|Analyses were performed in randomized patients who received ≥1 dose of study treatment and who had a post-randomization analysis measurement|||% (change FMD)||Standard Error|Mean
2758331|NCT00817843|Secondary|Preprandial Endopat Measurement||after 6 weeks of treatment (crossover)|||||||
2758332|NCT00817843|Secondary|Preprandial Endothelial Function Measured by FMD||after 6 weeks of treatment (crossover)|||||||
2758333|NCT00817843|Secondary|Postprandial Endopat Measurement||after 6 weeks of treatment (crossover)|||||||
2758334|NCT00817804|Secondary|Blood Pressure|Systolic and diastolic blood pressure|30 minutes|||||||
2758335|NCT00817804|Secondary|Heart Rate|Beats per minute that the patient's heart is beating|30 minutes|||||||
2758336|NCT00817804|Secondary|Minute Ventilation|Liters per minute that the patient breathes|30 minutes|||||||
2758337|NCT00817804|Secondary|Respiratory Rate|Breathing rate in breaths per minute|30 minutes||2011-12-31|12/2011||||
2758338|NCT00817804|Secondary|Saturation of Arterial Oxygen||30 minutes||2011-12-31|12/2011||||
2758339|NCT00817804|Primary|Breathing Comfort|Comfort on visual analog scale 0 - 100, 0 is best|30 minutes|Analysis was per protocol|||visual analog scale||Standard Error|Mean
2758340|NCT00817778|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment||||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
2758341|NCT00817778|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment||||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
2758342|NCT00817778|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment||||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
2758343|NCT00817778|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment||||L/h||Full Range|Geometric Mean
2758344|NCT00817778|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the afternoon dose last day of treatment||||h||Full Range|Geometric Mean
2758345|NCT00817778|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment||||h||Full Range|Median
2758346|NCT00817778|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured last day of treatment||||umol/L||Standard Deviation|Geometric Mean
2758347|NCT00817778|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment||||umol*h/L||Standard Deviation|Geometric Mean
2758348|NCT00817778|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose||||Participants|||Number
2758349|NCT00817778|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment||||kg||Standard Deviation|Mean
2758350|NCT00817778|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||beats/min||Standard Deviation|Mean
2758351|NCT00817778|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
2758352|NCT00817778|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
2758410|NCT00816829|Primary|Obstructive Apneas|Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).|at one month of treatment|The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of obstructive apneas||Full Range|Median
2758353|NCT00817596|Primary|Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.|"Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient.~The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio."|6 months - acute study|Sample size was based on previous testing and data from similar devices. With a population of 60 subjects the 90% CI would be 95 ± 7, or 0.88 to 1.02. Therefore, approximately 60 patients with 6-months of data will provide adequate data to demonstrate accuracy, although up to 110 patients may be implanted to account for patient drop-outs.|||% of programmed vol. actually delivered||90% Confidence Interval|Mean
2758354|NCT00817531|Primary|Clinical Efficacy|The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.|Assessment at pre-surgery or 3 to 4 weeks of treatment.|All patients started the treatment will be included in the analysis|||participants|||Number
2758355|NCT00817479|Primary|Increase in MKP1/DuSP1 mRNA Expression Level|Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.|||fold change||Standard Error|Mean
2758356|NCT00817479|Primary|Increase in SGK1 mRNA Expression Level|Increase in SGK1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.|||fold change||Standard Error|Mean
2758357|NCT00817336|Secondary|Visual P1||6 weeks|includes subjecst with valid visual p1 data|||micro volts||Standard Deviation|Mean
2758358|NCT00817336|Secondary|MATRICS|MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.|6 weeks|Final score after six weeks|||T score||Standard Deviation|Mean
2758359|NCT00817336|Primary|MMN Amplitude|Final MMN amplitude|6 weeks|Includes 11 subjects with analyzable MMN data|||micro volts||Standard Deviation|Mean
2758360|NCT00817336|Primary|PANSS Total|Positive and Negative Symptom Scale (PANSS) range 30-210|6 weeks|Final score end of six weeks|||units on a scale||Standard Deviation|Mean
2758361|NCT00817219|Secondary|PASI 50 at Week 4.|PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Week 4||||participants|||Number
2758362|NCT00817219|Secondary|PASI 75 at Week 4.|PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|4 weeks||||participants|||Number
2758363|NCT00817219|Secondary|Percentage Change in PASI From Baseline to Week 4.|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Baseline and 4 weeks||||percentage||95% Confidence Interval|Mean
2758364|NCT00817219|Secondary|"Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4."|The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).|Week 4||||participants|||Number
2758365|NCT00817219|Secondary|"Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4."|The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.|Week 4||||participants|||Number
2758366|NCT00817219|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.||Baseline and 4 Weeks||||mmol/g||Standard Deviation|Mean
2758367|NCT00817219|Primary|Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment||Baseline and 4 weeks||||mmol/L||Standard Deviation|Mean
2758368|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis|||participants|||Number
2758369|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis|||participants|||Number
2758371|NCT00817206|Primary|Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.||12 months|"One patient in each arm were randomized but not treated. Only treated patients (modified ITT population) is included in the primary outcome measure.~One patient death is listed under the Prograf arm; this patient died during follow up and did completet the study."|||participants|||Number
2758372|NCT00817089|Secondary|Adrenocorticotropic Hormone (ACTH) Levels|Change from baseline to peak cortisol response during the 2nd alcohol challenge session, objective response as measured by Adrenocorticotropic hormone (ACTH).|during 2nd alcohol challenge session||||pg/ml||Standard Deviation|Mean
2758373|NCT00817089|Primary|Biphasic Alcohol Effects Scale:Total Mood|"Change from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood.~Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes."|during 2nd alcohol challenge session||||units on a scale||Standard Deviation|Mean
2758374|NCT00817063|Secondary|Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency|An adverse change was defined as a change from normal at Baseline to abnormal at end of therapy. A missing adverse change was defined as missing results at Baseline and end of therapy, or missing result at Baseline and abnormal at end of therapy, or normal at Baseline and missing result at end of therapy. Other changes from Baseline to end of therapy are considered as no adverse change. All puretone testing used a modified Hughson-Westlake procedure with 5 decibel (dB) step size.|Up to Week 24|Safety Population. Only those participants who had audiologic evaluations were analyzed.|||Participants|||Count of Participants
2758375|NCT00817063|Secondary|Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure|An adverse change was defined as a change from normal at Baseline to abnormal at end of therapy, or as a worsening from Baseline for either or both eyes. A missing adverse change was defined as missing results at Baseline and end of therapy, or missing result at Baseline and abnormal at end of therapy, or normal at Baseline and missing result at end of therapy, or abnormal at Baseline and missing result at end of therapy, for both eyes or one eye when the other eye was not concerned by an adverse change. Other changes from Baseline to end of therapy was considered as no adverse change. Optic disc, macula, and retinal periphery were assessed by fundoscopy after pupil dilation using tropicamide.|Up to Week 24|Safety Population. Only those participants who had ophthalmological evaluations were analyzed.|||Participants|||Count of Participants
2758376|NCT00817063|Secondary|Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones|X-ray evaluations was done at Baseline (Week 0), end of therapy and at follow up period (Week 72). X-ray evaluations was done for Lateral C-Spine, Lateral T-Spine and Calcaneous. The images were evaluated as optimal, readable (but not optimal) or not readable.|Up to Week 72|Safety Population. Only those participants who had X-ray evaluations were analyzed.|||Participants|||Count of Participants
2758377|NCT00817063|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks|Bone mineral density scans of the left proximal femur (total hip) and anterior-posterior lumbar spine were obtained by use of DXA, at Baseline, at end of therapy, and 1 year (48 weeks) after end of therapy. In case of abnormality or surgery of the left hip, the right hip was to be used. If both hips were affected, the participant was not eligible for DXA. Vertebrae L1 to L4 had to be completely scanned. At least 3 vertebrae had to be free of any abnormalities potentially interfering with DXA analysis (eg, fractures, large osteophytes), otherwise the participant was not eligible for DXA. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100. Least square means and 95% confidence interval has been presented.|Baseline (Week 0) and Week 72|Safety Population. Only those participants available at the indicated time points were analyzed.|||Percent change||95% Confidence Interval|Least Squares Mean
2758378|NCT00817063|Secondary|Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks|Participants who developed tinnitus were monitored by use of the TOMI. The numbers of participants with pre-existing tinnitus, new tinnitus, increased/decreased loudness of tinnitus, or increased/decreased duration of tinnitus, pulsing quality of tinnitus were assessed.|Up to Week 24|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2758379|NCT00817063|Secondary|Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks|DHI assessed participants by handicap category: no handicap (0 to 14 points); mild handicap (16 to 34 points); moderate handicap (36 to 52 points); severe handicap (54 points). Increase from Baseline of <6 points, 6 to <12 points and 12 points. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.|Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24|Safety Population. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2758380|NCT00817063|Secondary|Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks|HHIE-S assessed participants by handicap category: no handicap (0 to 8 points); mild/moderate handicap (10 to 24 points); severe handicap (26-40 points). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.|Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24|Safety Population. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2758381|NCT00817063|Secondary|Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks|Participants meeting any of the following criteria were to be referred for specialist psychiatric evaluation within 2 weeks: PHQ-9 Score >=15, Two Subsequent Scores of >=10 and PHQ-9 Question 9 >=1. The PHQ -9 was a standardized tests of mood/depression. This was a nine item measure with a response for each item between 0-3 where, 0=not at all, 1= several days, 2= more than half the days, 3= nearly everyday. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.|Up to 28 Weeks|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2758382|NCT00817063|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks|The PHQ-9 was a standardized tests of mood/depression. This was a nine item measure with a response for each item between 0-3 where, 0=not at all, 1= several days, 2= more than half the days, 3= nearly every day. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.|Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24, 28|Safety population. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2758383|NCT00817063|Secondary|Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks|"The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., your feelings being easily hurt) on a 5-point scale where, 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely (0 indicates best outcome and 4 indicates worst outcome). The total score ranged from 0 (best outcome) to 212 (worse outcome). Participants with an increase above Baseline of 25% or more on any domain subscore in BSI-53, or with an increase above Baseline of >=2 points or a score >=3 on any BSI-53 item that reflects depression, suicidality, psychotic symptoms, and hostility/aggression, were to be referred to a psychiatrist within 2 weeks."|Up to Week 24|Safety population. Only those participants meeting the criteria of referring to psychiatrist were analyzed.|||Participants|||Count of Participants
2758384|NCT00817063|Secondary|Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range|Blood samples were collected for the assessment of laboratory parameters hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin concentration, reticulocytes, platelets, white blood cell, lymphocytes, neutrophils, monocytes, eosinophils, basophils, total bilirubin, bilirubin conjugated (direct), aspartate amino transferase (AST), alanine amino transferase (ALT), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), alkaline phosphatase (ALP), total protein, serum albumin, glucose, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, sodium, potassium, chloride, serum calcium, serum phosphate, serum creatinine, blood urea nitrogen (BUN)/urea, uric acid, Free thyroxin and thyroid stimulating hormone (TSH) at Baseline and every 4 weeks of treatment period and Week 28 of follow up period. Data for participants with values outside the marked reference range are reported.|Up to Week 28|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2758385|NCT00817063|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period|An AE was defined as any adverse change from the participant's Baseline (pretreatment) clinical condition, including intercurrent illness, which occurred during the course of the clinical study after written informed consent had been given, whether considered related to treatment or not. A treatment-emergent AE was defined as any adverse change that occurred after treatment started and up to 7 days after last treatment. An SAE was any experience that suggested a significant hazard, contradiction, side effect or precaution. It was any adverse event that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect.|Up to Week 24 (end-of-treatment)|Safety Population included all randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2758386|NCT00817063|Secondary|Time to Response for Responding Participants at End-of-therapy|"Time to response was defined as time from start of treatment to first PGA assessment of clear or almost clear. Median and inter-quartile range has been presented."|Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)|ITT population. Only those participant who responded to PGA assessment at the end of therapy was analyzed.|||Days||Inter-Quartile Range|Median
2758387|NCT00817063|Secondary|Time to Relapse for Responding Participants at the End-of-therapy|Time to relapse was defined as the time from end-of-therapy to the first diagnosis of severe CHE. Median and inter-quartile range has been presented. The median was based on the very last participant having a follow-up period longer than expected, those explaining the high median.|Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)|ITT population.|||Weeks||Inter-Quartile Range|Median
2758388|NCT00817063|Secondary|Response Duration for Responding Participants at the End-of-therapy|Response Duration was defined as time from the end-of-therapy to the first diagnosis of mild, moderate, or severe CHE. Median and inter-quartile range has been presented.|Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)|ITT population.|||Weeks||Inter-Quartile Range|Median
2758389|NCT00817063|Secondary|Percentage Change From Baseline in Extent of Disease at End-of-treatment|The extent of disease was estimated as the percentage of hand area (with 100% defined as the palmar and dorsal aspects) affected by eczema at Baseline, and at the end of treatment). Extent of disease was estimated separately for the left and right hands, and the overall extent of disease for both hands was calculated as (Left+Right)/2. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100.|Baseline (Week 0) and Week 24 (end-of-treatment)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2758390|NCT00817063|Secondary|Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment|At Week 24 or at the end-of-treatment participants were asked by the investigator to grade their overall change from Baseline by selecting one of the following descriptions, which best matched their perception of overall treatment effect: cleared or almost cleared (at least 90% clearing), marked improvement (at least 75% clearing), moderate improvement (at least 50% clearing), mild improvement (at least 25% clearing), no change and worsening. Participants were considered as responders when the PaGa was cleared or almost cleared.|Week 24 (end-of-treatment)|ITT Population.|||Participants|||Count of Participants
2758411|NCT00816777|Secondary|Overall Survival||1 year|Study terminated ealry no data collected||||||
2758412|NCT00816777|Secondary|Performance Status (ECOG)|No data collected|1 year|Study terminated early||||||
2758413|NCT00816777|Secondary|Change in Tumor Marker||1 year|Study terminated early. No Data collected||||||
2758391|NCT00817063|Secondary|Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment|A 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) was used to grade 7 signs or symptoms of CHE. The mTLSS was calculated as sum of assigned scores for the symptoms of erythema, scaling, lichenification/hyperkeratosis, vesiculation, edema, fissures and Pruritus/Pain. The total score ranged from 0 (best) to 21 (worst). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100. Data for Week 24 last observation carried forward (LOCF) has been presented.|Baseline (Week 0) and Week 24 (end-of-treatment)|ITT population.|||Percent change||Standard Deviation|Mean
2758392|NCT00817063|Primary|Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24|The investigator assigned PGA grades according to a 5-point scale (clear [not detectable], almost clear [less than 10% of affected hand surface], mild disease [less than 10% of affected hand surface], moderate disease [10% to 30% of affected hand surface], severe disease [>30% of affected hand surface]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.|Week 24 (end-of-treatment)|ITT Population.|||Participants|||Count of Participants
2758393|NCT00816907|Secondary|Change in Hemoglobin A1c From Baseline to 16 Weeks|glycosylated hemoglobin|16 weeks|participants who took assigned treatment|||percent||95% Confidence Interval|Least Squares Mean
2758394|NCT00816907|Secondary|Change in Fasting Insulin From Baseline to 16 Weeks|Fasting insulin|16 weeks|participants who took assigned treatment|||mU/L||95% Confidence Interval|Mean
2758395|NCT00816907|Secondary|Change in Fasting Glucose From Baseline to 16 Weeks|fasting blood glucose|16 weeks|participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
2758396|NCT00816907|Secondary|Change in Triglycerides From Baseline to 16 Weeks|serum triglycerides|16 weeks|participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
2758397|NCT00816907|Secondary|Change in LDL Cholesterol From Baseline to 16 Weeks|low-density lipoprotein|16 weeks|participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
2758398|NCT00816907|Secondary|Change in HDL Cholesterol From Baseline to 16 Weeks|high-density lipoprotein|16 weeks|randomized participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
2758399|NCT00816907|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks|Total cholesterol|16 weeks|randomized participants who took assigned treatment|||mg/dL||95% Confidence Interval|Mean
2758400|NCT00816907|Primary|Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo|Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)|Measured at the last study visit|Evaluable population that took assigned study treatment|||kilograms||95% Confidence Interval|Mean
2758401|NCT00816829|Primary|Index of Hypopneas|Average number of hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number per hour of sleep||Full Range|Median
2758402|NCT00816829|Primary|Index of Apneas|Average number of apneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number per hour of sleep||Full Range|Median
2758403|NCT00816829|Primary|Central Apneas|Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of central apneas||Full Range|Median
2758404|NCT00816829|Primary|Mixed Apneas|Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of mixed apneas||Full Range|Median
2758405|NCT00816829|Primary|Index Apnea/Hypopnea|Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number per hour of sleep||Full Range|Median
2758406|NCT00816829|Primary|Hypopneas|Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of hypopneas||Full Range|Median
2758407|NCT00816829|Primary|Apneas|Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of apneas||Full Range|Median
2758408|NCT00816829|Primary|Sleep Time With Oxygen Saturation Below 90%|Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Percentage of sleep time||Full Range|Median
2758409|NCT00816829|Primary|Desaturations|Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).|||Number of desaturations||Full Range|Median
2758414|NCT00816777|Secondary|Hepatic Progression Free Survival|Data not collected - study terminated ealry|1 year|Early termination - data not collected||||||
2758415|NCT00816777|Secondary|Local Tumor Response (Extent of Necrosis in the Treated Lesions)||1 year|Study terminated ealry - data not collected||||||
2758421|NCT00816595|Secondary|Progression-free Survival|The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.|||months||95% Confidence Interval|Median
2758422|NCT00816595|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.|||months||95% Confidence Interval|Median
2758423|NCT00816595|Primary|Complete and Overall Response Rate|"A Complete Response (CR) requires all of the following for 2 months:~Absence of lymphadenopathy by physical examination (PE)~No hepato- or splenomegaly by PE~Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL~Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples.~A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available.~A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin.~Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients."|Evaluated after 6 cycles (up to 196 days)|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.|||percentage of patients|||Number
2758424|NCT00816556|Secondary|Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks||||pg/ml||Standard Deviation|Mean
2758425|NCT00816556|Secondary|Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks||||pg/ml||Standard Deviation|Mean
2758426|NCT00816556|Primary|Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12|The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.|baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2758427|NCT00816400|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, OS was censored on the last date when participants were known to be alive.|From the start of treatment with MEDI-575 until death or end of study, up to 33 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure|||Months||95% Confidence Interval|Median
2758428|NCT00816400|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. PFS was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.|Start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause whichever occurs first, up to 24 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure|||Months||95% Confidence Interval|Median
2758429|NCT00816400|Secondary|Time to Progression|Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. TTP was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.|Start of treatment with MEDI-575 until the documentation of disease progression, up to 24 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure|||Months||95% Confidence Interval|Median
2758430|NCT00816400|Secondary|Duration of Response|Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was calculated for the subgroup of participants with an objective response.||Efficacy evaluable population with an objective response. Duration of response was not estimable as there were no participants with an objective response.||||||
2758518|NCT00815659|Secondary|Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment|IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-10 levels of participants|||pg/mL||Standard Deviation|Mean
2758431|NCT00816400|Secondary|Time to Response|Time to response was measured from the start of treatment with MEDI-575 to the first documentation of objective response (confirmed CR or PR). The time to response is assessed only for the participants who have achieved the objective response.||Efficacy evaluable population with an objective response. Time to response was not estimable as there were no participants with an objective response.||||||
2758432|NCT00816400|Secondary|Percentage of Participants With Objective Response|Objective response rate is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after the initial documentation of response. The CR is defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|From study entry through the end of the study, up to 34 months|Efficacy evaluable population: All participants who have received any treatment of MEDI-575 and at least one tumor assessment after the initiation of MEDI-575.|||Percentage of participants||95% Confidence Interval|Number
2758433|NCT00816400|Secondary|Number of Participants Positive for Anti-drug Antibodies Formation for MEDI-575 at Any Visit|Blood samples for immunogenicity assessments were collected from participants prior to the initiation of infusion of each treatment cycle of MEDI-575. Anti-MEDI-575 antibodies were analyzed using the electro-chemiluminescence (ECL) based method. Only the number of participants positive for anti-MEDI-575 antibodies at any visit are presented.|Preinfusion on Cycle 1 Day 1 and 30 days after the last dose, up to 112 weeks|Safety population|||Participants|||Number
2758434|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Dose-normalized Area Under the Serum Concentration-time Curve (AUCτ/Dose)|The AUCτ/dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.|||μg·day/mL/mg||Standard Deviation|Mean
2758435|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCτ)|The AUCτ was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.|||μg·day/mL||Standard Deviation|Mean
2758436|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Trough Serum Concentration (Ctrough)|The Ctrough ie, measured concentration at the end of a dosing interval (taken directly before next dose administration) of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.|||μg/mL||Standard Deviation|Mean
2758437|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Dose-normalized Maximum Serum Concentration (Cmax/Dose)|The Cmax/dose after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.|||μg/mL/mg||Standard Deviation|Mean
2758438|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Time to Maximum Concentration (Tmax)|The time to reach maximum serum concentration after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.|||Day||Standard Deviation|Mean
2758439|NCT00816400|Secondary|Pharmacokinetics (PK) of MEDI-575 After the First Dose: Observed Maximum Serum Concentration (Cmax)|The concentration of MEDI-575 quantitatively determined in serum samples using a validated electrochemiluminescence (ECL) PK assay. The Cmax after the first dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.|||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2758519|NCT00815659|Secondary|Basal Interleukin 10 (IL-10) Level|IL-10 levels before (Visit 2-enrollment)|Baseline|Baseline IL-10 levels of participants|||pg/mL||Standard Deviation|Mean
2758440|NCT00816400|Primary|Maximum Tolerated Dose (MTD)|For the dose escalation phase, a minimum of 21 evaluable participants (3 participants each in Dose Cohorts 1 through 7) were required for this study if Dose Limiting Toxicities (DLTs) do not occur. If a DLT does occur among the first 3 participants in a cohort, 3 additional participants were to be added to the cohort; 3 more participants were to be added to a cohort to determine the MTD if only 3 participants have been previously treated at that dose. The MTD is the maximum dose at which no more than 1 out of 6 participants experienced a DLT. A DLT is defined as any grade 3 or higher hematologic toxicity or any grade 3 or higher non-hematologic toxicity except grade 3 fever (in the absence of neutropenia) or grade 3 rigors/chills.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|MTD evaluable population includes all participants in the dose escalation phase who have received at least 1 full cycle of MEDI-575 and have completed the safety follow-up through the DLT-evaluation period, or who experienced a DLT. The MTD dose was not evaluated as there were no DLTs reported in this study.|||Milligrams per kilogram (mg/kg)|||Number
2758441|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Vital Sign Parameters|Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
2758442|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time interval) and analyzed. ECG parameters included heart rate (high and low), QT interval, QTcB (corrected QT interval per Bazett's formula), and QTcF (corrected QT interval per Fridericia's formula). Number of participants with TEAEs related to ECG after the start of study drug were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
2758443|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (complete blood count, differential, and platelet count); serum chemistry (SrChem) aspartate transaminase (AST), alanine transaminase, total bilirubin, creatinine, alkaline phosphatase, sodium, potassium, chloride, phosphorus, calcium, glucose, magnesium, albumin, and lactate dehydrogenase); and routine urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
2758444|NCT00816400|Primary|Number of Participants With Serious Adverse Events|A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs that emerged after start of study drug were reported. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The SAEs were summarized using MedDRA version 14.1.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
2758445|NCT00816400|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 14.1.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population: All participants who have received any treatment of MEDI-575|||Participants|||Number
2758446|NCT00816361|Secondary|Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573|The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.|From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N and n represent number of participants analyzed for this outcome measure and at specific time points, respectively."|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2758447|NCT00816361|Secondary|Duration of Response|Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.|From study entry through the end of the study, up to 3.5 years|Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.||||||
2758448|NCT00816361|Secondary|Time to Response (TTR)|Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.|From study entry through the end of the study, up to 3.5 years|Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.||||||
2758449|NCT00816361|Secondary|Overall Survival|Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.|From study entry through the end of the study, up to 3.5 years|"Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, N is number of participants analyzed for this outcome measure."|||Months||Full Range|Median
2758520|NCT00815659|Secondary|Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment|IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-8 levels of participants|||pg/mL||Standard Deviation|Mean
2758450|NCT00816361|Secondary|Time to Progression|Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.|From study entry through the end of the study, up to 3.5 years|"Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, N is number of participants analyzed for this outcome measure."|||Months||95% Confidence Interval|Median
2758451|NCT00816361|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.|From study entry through the end of the study, up to 3.5 years|"Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, N is number of participants analyzed for this outcome measure."|||Months||95% Confidence Interval|Median
2758452|NCT00816361|Secondary|Objective Response Rate (ORR)|The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline [screening]) and no new lesions.|From study entry through the end of the study, up to 3.5 years|The Efficacy Evaluable Population included all participants who received MEDI-573 and had at least one tumor assessment after the initiation of treatment. Participants in the dose-expansion phase were to have at least 1 lesion that was measurable using RECIST criteria, and a histologically confirmed diagnosis of advanced urothelial carcinoma.|||Percentage of Participants|||Number
2758453|NCT00816361|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573|Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.|Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||Participants|||Count of Participants
2758454|NCT00816361|Secondary|Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)|The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.|For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||mcg*day/mL/mg||Standard Deviation|Mean
2758455|NCT00816361|Secondary|Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)|Area under the serum concentration-time curve over the first dosing interval.|For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||mcg*day/mL||Standard Deviation|Mean
2758456|NCT00816361|Secondary|Dose Normalized Cmax (Cmax/Dose) After the First Dose|The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.|For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||mcg/mL/mg||Standard Deviation|Mean
2758457|NCT00816361|Secondary|Trough Serum Concentration (Ctrough) After the First Dose|The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.|For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||mcg/mL||Standard Deviation|Mean
2758458|NCT00816361|Secondary|Time to Reach Maximum Observed Concentration (Tmax) After the First Dose|The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.|For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||Day||Full Range|Median
2758459|NCT00816361|Secondary|Maximum Observed Serum Concentration (Cmax) After the First Dose|The Cmax was the maximum observed serum concentration of MEDI-573.|For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15|"The Safety Population included all participants who had received any MEDI-573 treatment. Here, N is number of participants analyzed for this outcome measure."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2758460|NCT00816361|Primary|Optimal Biologically Effective Dose (OBED) of MEDI‑573|The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.|From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years|Safety population: Participants in the dose-escalation phase were analyzed for this outcome measure.|||mg/kg|||Number
2758513|NCT00815659|Secondary|Basal LDL-3 Level|LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls|Baseline|Baseline LDL-3 levels of participants|||mg/mL||Standard Deviation|Mean
2758461|NCT00816361|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as any grade greater than or equal to (>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (<) 4 serum-high glucose (fasting) with duration of < 24 hours; Grade 3 fever (in the absence of neutropenia) defined as > 40.0 degree centigrade (°C) [greater than (>) 104.0°F] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade >= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.|Cycle 1 Day 1 through Cycle 1 Day 21|The Safety Population included all participants who had received any MEDI-573 treatment.|||Participants|||Number
2758462|NCT00816361|Primary|Maximum Tolerated Dose (MTD) of MEDI-573|The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.|Cycle 1 Day 1 through Cycle 1 Day 21|MTD Evaluable Population included all participants in dose-escalation phase who had received at least 1 full cycle of MEDI-573 and completed safety follow-up through DLT period (Cycle 1 Day 1 through Cycle 1 Day 21), or who experienced a DLT. Two participants did not receive a full cycle of MEDI-573 and therefore excluded from MTD population.|||mg/kg|||Number
2758463|NCT00816361|Primary|Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs|Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.|From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years|The Safety Population included all participants who had received any MEDI-573 treatment.|||Participants|||Count of Participants
2758464|NCT00816361|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.|From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years|The Safety Population included all participants who had received any MEDI-573 treatment.|||Participants|||Count of Participants
2758465|NCT00816361|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)|AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.|From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years|The Safety Population included all participants who had received any MEDI-573 treatment.|||Participants|||Count of Participants
2758466|NCT00816348|Primary|Level of Bilirubin|measurement of bilirubin level weekly. Available data reported.|week 2, 3,4,and 8||||mg/dL||Standard Deviation|Mean
2758467|NCT00816166|Primary|Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months|"The primary effectiveness endpoint was a composite of the two following outcomes:~Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization~Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization~A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.~The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months)."|One Year|Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received.|||percent probability||95% Confidence Interval|Number
2758468|NCT00816101|Secondary|Erythema at Week 3|"At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with 0 being No erythema, 1 being Very slight erythema, 2 being Well defined erythema, 3 being Moderate to severe erythema and 4 being Severe erythema to slight eschar formation"|3 Weeks||||Erythema Scores on a Scale||Standard Deviation|Mean
2758469|NCT00816101|Secondary|Number of Patients Reporting Pain|Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.|3 Weeks||||Participants|||Number
2758470|NCT00816101|Primary|Number of Patients Who Experienced 50% or Greater Wound Healing|Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported|3 Weeks||||Participants|||Number
2758521|NCT00815659|Secondary|Basal Interleukin 8 (IL-8) Level|IL-8 levels before (Visit 2-enrollment)|Baseline|Baseline IL-8 levels of participants|||pg/mL||Standard Deviation|Mean
2758471|NCT00816062|Primary|Freedom From Aneurysm-related Mortality (ARM)|ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.|5 year Kaplan Meier (KM)|All enrolled subjects.|||Proportion of participants||95% Confidence Interval|Number
2758472|NCT00816036|Secondary|Prescription of Recommended Pharmacotherapy for Smoking Cessation||Assessed within 72 hours of hospital discharge||||participants|||Number
2758473|NCT00816036|Secondary|Referrals to Quitline||Assessed within 72 hours of hospital discharge||||participants|||Number
2758474|NCT00816036|Primary|7-day Point-prevalence Smoking Abstinence (6-month)|This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.|6 months post enrollment|This is the total number of subjects who completed 6 month follow-up (complete case analysis).|||participants|||Number
2758475|NCT00816023|Secondary|Treatment-emergent Adverse Events||Over the duration of the study.|Analysis conducted on Safety population, defined as all subjects randomized and received any study drug. Treatment groups are based on actual treatment received.|||participants|||Number
2758476|NCT00816023|Primary|Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery||Start of surgery up to 12 hours after the end of surgery|The Modified Intent to Treat population was the basis of this analysis, defined as all randomized subjects who received any amount of study drug and analyzed according to the planned treatment assignment.|||mL||Standard Deviation|Mean
2758477|NCT00815997|Secondary|Time Used for Hemostasis|Time Used for Hemostasis (minutes).|within 2 days afterTRI||||minutes||Standard Error|Mean
2758478|NCT00815997|Secondary|Time Used for the Procedure|Time used for the procedure (minutes).|At the end of TRI||||minutes||Standard Deviation|Mean
2758479|NCT00815997|Secondary|Contrast Dye Volume Used for the Procedure|Contrast dye volume used for the procedure (mL).|At the end of TRI||||mL||Standard Deviation|Mean
2758480|NCT00815997|Secondary|Fluoroscopy Time Used for the Procedure|Fluoroscopy time used for the procedure (minutes).|At the end of TRI||||minutes||Standard Deviation|Mean
2758481|NCT00815997|Secondary|Number of Patients With Access-site Complications|Access-site-related complications were defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery, which were considered to be major if they were associated with a vascular repair or a blood transfusion.|within 2 days after TRI||||Participants|||Count of Participants
2758482|NCT00815997|Secondary|Number of Patients With Measure Adverse Cardiac Event (MACE)|Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization|within 2 days after TRI||||participants|||Number
2758483|NCT00815997|Secondary|Number of Patients With Successful PCI|Procedural success was defined as a postprocedural residual stenosis of less than 20%, and a thrombolysis in myocardial infarction (TIMI) grade 3 angiographic flow without MACE during in-hospital follow-up.|within 2 days after TRI||||participants|||Number
2758484|NCT00815997|Primary|Number of Patients With Radial Artery Occlusion|The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test.|within 2 days after TRI||||Participants|||Count of Participants
2758485|NCT00815919|Secondary|Overall and cGVHD Progression-free Survival by 1 Year After Therapy||2 years||||percentage of participants||95% Confidence Interval|Number
2758486|NCT00815919|Secondary|Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy|Participants who were still being followed 1 year after the start of therapy had their prednisone dose recorded.|1 year after the start of study treatment|Participants who were still being followed 1 year after the start of therapy.|||participants|||Number
2758487|NCT00815919|Secondary|The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|Participants' toxicities were graded based on the CTCAE version 3.0. The toxicities were then given an attribution to the velcade treatment: unrelated, unlikely, possible, probable, definite.|Toxicities were collected from the start of treatment through 15 weeks of therapy or end of study treatmetn||||participants|||Number
2758488|NCT00815919|Secondary|Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|The participants' total daily steroid dose was recorded at baseline and after a 15 week course of treatment. Starting at a dose of 0.5-1 mg/kg, dose reduction of steroids was permitted after 1 cycle of therapy. The suggested taper was 10-25% every 1-2 weeks. .|After 15 weeks of bortezomib plus prednisone therapy|Of the overall 22 patients, 18 patients completed 3 cycles (15 weeks) of therapy|||participants|||Number
2758489|NCT00815919|Primary|Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|"Participants had their cGVHD evaluated per NIH consensus criteria:~Complete response: resolution of all reversible manifestations of cGVHD.~Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites.~Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD.~Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressive agent prior to the completion of 15 weeks of combination therapy, or requirement an increase in the total daily dose of corticosteroids above a participant's baseline corticosteroid dose during the 15-week combined treatment period.~Mixed response: a response in primary sites of cGVHD involvement but interval progressive cGVHD in other organs or sites.~Responses were not scored for oral or ocular cGVHD, since topical therapies were permitted during the study."|Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy||||participants|||Number
2758514|NCT00815659|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment|hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants|||mg/mL||Standard Deviation|Mean
2758515|NCT00815659|Secondary|Basal High Sensitivity C-reactive Protein (Hs-CRP) Level|hs-CRP levels before (Visit 2-enrollment)|Baseline|Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants|||mg/mL||Standard Deviation|Mean
2758490|NCT00815776|Secondary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)|"The arm that includes 0 (Mouth Splint Group) is included in the Primary Outcome Measure."|||Units on a scale||Standard Deviation|Mean
2758491|NCT00815776|Primary|Number of Subjects With Adverse Events|Subjects were assessed for adverse events from the baseline visit through study completion (3 months post-baseline). Adverse events were categorized by the investigator for severity and relationship to treatment.|From Baseline through 3 months post-baseline visit.||||Participants|||Number
2758492|NCT00815776|Primary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)|"The arm that includes 0 (Jaw Exercise) is reported in Seconary Outcome Measure Table."|||Units on a scale||Standard Deviation|Mean
2758493|NCT00815698|Secondary|Recurrence|recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.|12 months after surgery||||participants|||Number
2758494|NCT00815698|Primary|Pain, Numbness and Discomfort in the Groin|The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.|12 months after surgery||||participants|||Number
2758495|NCT00815685|Secondary|Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.|"There is no expected range for normal activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA."|6 weeks per patient|Participants with available pre and post-treatment serum samples.|||Participants|||Number
2758496|NCT00815685|Primary|Change in Serum Albumin|Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.|6 weeks per patient||||g/dL||Full Range|Median
2758497|NCT00815659|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events in 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Number of patients with any adverse events in 3 months|||Participants|||Number
2758498|NCT00815659|Secondary|Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants|||mg/mL||Standard Deviation|Mean
2758499|NCT00815659|Secondary|Basal Small HDL Subfraction Level|Small HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Small HDL subfraction of participants|||mg/mL||Standard Deviation|Mean
2758500|NCT00815659|Secondary|Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants|||mg/mL||Standard Deviation|Mean
2758501|NCT00815659|Secondary|Basal Intermediate HDL Subfraction Level|Intermediate HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Intermediate HDL subfraction of participants|||mg/mL||Standard Deviation|Mean
2758502|NCT00815659|Secondary|Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants|||mg/mL||Standard Deviation|Mean
2758503|NCT00815659|Secondary|Basal Large HDL Subfraction Level|Large HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Large HDL subfraction of participants|||mg/mL||Standard Deviation|Mean
2758504|NCT00815659|Secondary|LDL-7 Level After 3 Months of Rosuvastatin Treatment|LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-7 levels of participants|||mg/mL||Standard Deviation|Mean
2758505|NCT00815659|Secondary|Basal LDL-7 Level|LDL-7 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-7 levels of participants|||mg/mL||Standard Deviation|Mean
2758506|NCT00815659|Secondary|LDL-6 Level After 3 Months of Rosuvastatin Treatment|LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-6 levels of participants|||mg/mL||Standard Deviation|Mean
2758507|NCT00815659|Secondary|Basal LDL-6 Level|LDL-6 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-6 levels of participants|||mg/mL||Standard Deviation|Mean
2758508|NCT00815659|Secondary|LDL-5 Level After 3 Months of Rosuvastatin Treatment|LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-5 levels of participants|||mg/mL||Standard Deviation|Mean
2758509|NCT00815659|Secondary|Basal LDL-5 Level|LDL-5 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-5 levels of participants|||mg/mL||Standard Deviation|Mean
2758522|NCT00815659|Secondary|Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment|IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-6 levels of participants|||pg/mL||Standard Deviation|Mean
2758523|NCT00815659|Secondary|Basal Interleukin 6 (IL-6) Level|IL-6 levels before (Visit 2-enrollment)|Baseline|Baseline IL-6 levels of participants|||pg/mL||Standard Deviation|Mean
2758524|NCT00815659|Secondary|Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment|IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-1 levels of participants|||pg/mL||Standard Deviation|Mean
2758525|NCT00815659|Secondary|Basal Interleukin 1 (IL-1) Level|IL-1 levels before (Visit 2-enrollment)|Baseline|Baseline IL-1 levels of participants|||pg/mL||Standard Deviation|Mean
2758526|NCT00815659|Primary|Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Non-HDL cholesterol target levels <130 mg/dL, calculated over patients with lipid measurement performed at both visits|||Participants|||Number
2758527|NCT00815659|Primary|Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits|||Participants|||Number
2758528|NCT00815659|Primary|Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL|3 months (from enrollment to last visit)|LDL cholesterol levels < 100 mg/dL, calculated over patients with lipid measurement performed at both visits|||Participants|||Number
2758529|NCT00815659|Primary|Triglyceride Level After 3 Months of Rosuvastatin Treatment|Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) triglyceride levels of participants|||mg/dL||Standard Deviation|Mean
2758530|NCT00815659|Primary|Basal Triglyceride Level|Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline triglyceride levels of participants|||mg/dL||Standard Deviation|Mean
2758531|NCT00815659|Primary|Total Cholesterol Level After 3 Months of Rosuvastatin Treatment|Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) total cholesterol levels of participants|||mg/dL||Standard Deviation|Mean
2758532|NCT00815659|Primary|Basal Total Cholesterol Level|Baseline|Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline total cholesterol levels of participants|||mg/dL||Standard Deviation|Mean
2758533|NCT00815659|Primary|LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL levels of participants|||mg/dL||Standard Deviation|Mean
2758534|NCT00815659|Primary|Basal LDL-cholesterol Level|LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline LDL levels of participants|||mg/dL||Standard Deviation|Mean
2758535|NCT00815659|Primary|HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) HDL levels of participants|||mg/dL||Standard Deviation|Mean
2758536|NCT00815659|Primary|Basal HDL-cholesterol Level|HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline||||mg/dL||Standard Deviation|Mean
2758537|NCT00815633|Primary|Evidence of Skin Change - PRP Area and Severity Index (PASI)||wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24|study terminated before data collected||||||
2758538|NCT00815633|Primary|Evidence of Skin Change - Physician's Global Assessment (PGA)||wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24|study terminated before data collected||||||
2758539|NCT00815516|Secondary|Plasma Micafungin Concentration||15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV|The pharmacokinetics (PK) analysis set, including those infants who received any amount of study drug, have at least one study drug concentration, and have dosing and blood collection date and time data sufficient for inclusion in a population pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2758540|NCT00815516|Secondary|Follow-up Status for Infants With End-organ Assessments|"End-organ dissemination was assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam. Each specific finding, documented by 1 of these techniques, was evaluated as follows:~Improvement: Improvement in size, number or density of identified lesions. Complete response was not expected but may have been documented.~Stabilization: Minor improvement or no change in size, number or density of identified lesions.~Worsening: Increase in size or number of identified lesions."|Baseline and 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with end-organ assessments|||percentage of participants|||Number
2758541|NCT00815516|Secondary|Mycological Response One Week After Last Dose of Study Drug|"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site."|One week after the last dose of study drug (maximum of 49 days)|Full analysis set|||percentage of participants|||Number
2758586|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.|36 Months|Intention-to-Treat|||percentage of participants|Participants||Number
2758542|NCT00815516|Secondary|Mycological Response at End of Study Drug Therapy|"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site."|End of study drug therapy; maximum of 42 days|Full analysis set|||percentage of participants|||Number
2758543|NCT00815516|Secondary|Clinical Response One Week After Last Dose of Study Drug|"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and one week after the last dose of study drug (maximum of 49 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline|||percentage of participants|||Number
2758544|NCT00815516|Secondary|Clinical Response at the End of Study Drug Therapy|"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and end of study drug therapy; maximum of 42 days|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline|||percentage of participants|||Number
2758545|NCT00815516|Secondary|Time to Positive Clinical Response|"Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator.~Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline.~Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline|||days||95% Confidence Interval|Median
2758546|NCT00815516|Secondary|Percentage of Participants With Recurrent Fungal Infections|A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection.|Up to 30 days after the last dose of study drug (maximum of 72 days)|Participants in the full analysis set with eradication at the end of study drug therapy.|||percentage of participants||95% Confidence Interval|Number
2758547|NCT00815516|Secondary|Percentage of Participants With Emergent Fungal Infections|"An emergent fungal infection is defined as~An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or~An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection."|Up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2758548|NCT00815516|Secondary|Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|One week after the last dose of study drug (maximum of 49 days)|Participants in the full analysis set with end-organ dissemination|||percentage of participants||95% Confidence Interval|Number
2758549|NCT00815516|Secondary|Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|The end of study drug therapy; maximum of 42 days|Participants in the full analysis set with end-organ dissemination|||percentage of participants||95% Confidence Interval|Number
2758550|NCT00815516|Secondary|Time to Mycological Clearance of Invasive Candidiasis|"Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection.~Eradication was defined as a culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for for Candida meningitis and/or candiduria, 1 negative culture.~Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set|||days||95% Confidence Interval|Median
2758587|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.|36 Months|Intention-to-Treat|||percentage of participants|||Number
2758551|NCT00815516|Primary|Fungal-free Survival|"Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment.~Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture."|One week after the last dose of study drug (maximum of 49 days)|Full Analysis Set (all randomized infants who were administered any amount of study drug)|||percentage of participants||95% Confidence Interval|Number
2758552|NCT00815490|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.|||percentage saturation||Full Range|Mean
2758553|NCT00815360|Secondary|Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months||6 months||||units on a scale (microns)|Participants|95% Confidence Interval|Mean
2758554|NCT00815360|Primary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.||6 months|We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA.|||Letters of visual acuity on ETDRS chart|Participants|95% Confidence Interval|Mean
2758555|NCT00815347|Secondary|Asthma Control Test Questionnaire|Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)|end of each dosing period||||scores on a scale||Standard Deviation|Mean
2758556|NCT00815347|Other Pre-specified|Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry.||17 weeks|||||||
2758557|NCT00815347|Other Pre-specified|Requirement for Urgent Medical Care for Asthma.||17 weeks|||||||
2758558|NCT00815347|Other Pre-specified|Requirement for Escalation of Controller Medication.||17 weeks|||||||
2758559|NCT00815347|Secondary|Rescue Beta-agonist||end of each dosing period||||puffs of rescue inhaler||Standard Deviation|Mean
2758560|NCT00815347|Secondary|FEV1||end of dosing period||||liters||Standard Deviation|Mean
2758561|NCT00815347|Primary|Symptom Scores|Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)|Last 7 days of each dosing period||||score on a scale||Standard Deviation|Mean
2758562|NCT00815347|Primary|Peak Flow||last 7 days of each dosing period|Data not analyzed, study terminated early||||||
2758563|NCT00815347|Primary|Change in FEV1||1, 2, 4 hours after dosing||||liters||95% Confidence Interval|Mean
2758564|NCT00815308|Secondary|Number of Participants With K-ras Gene Mutation|DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.|07/29/2010-09/30/2010||||participants|||Number
2758565|NCT00815308|Secondary|Participants With Progression Free Survival (PFS)||Recurrence or metastasis from the date of diagnosis||2013-08-31|08/2013||||
2758566|NCT00815308|Secondary|Participants With Overall Survival (OS) at 3 Year||3 year from the date of diagnosis||2013-08-31|08/2013||||
2758567|NCT00815308|Secondary|Participants With Overall Survival (OS) at 1 Year||1 year from the date of diagnosis||2011-08-31|08/2011||||
2758568|NCT00815308|Secondary|Number of Participants With Toxicity|All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.|Every week during treatment and 1 month after therapy||||participants|||Number
2758569|NCT00815308|Primary|Number of Participants With Overall Response Rate (RR)|The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|1 to 3 month after therapy||||participants|||Number
2758570|NCT00815295|Secondary|Phase 2 - Mean Change From Baseline in Quality of Life - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)|The outcome measure is the mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the FACT-H&N. The instrument consists of 39 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-bing (FWB) and additional head and neck specific concerns (HNCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and HNCS scores (12 items). TOI ranges from 0 to 140.|5 years|QOL data were not consistently collected and can not be analyzed.||||||
2758571|NCT00815295|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death due to any cause. Per RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years||||months||95% Confidence Interval|Number
2758572|NCT00815295|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.|||months||95% Confidence Interval|Number
2758573|NCT00815295|Primary|Tumor Control Rate|The proportion of patients for whom the best overall response is complete response (CR), partial response (PR) or stable disease (SD). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. If follow-up assessments are not available, the best overall response is unevaluable.|1 year|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.|||percentage of participants||95% Confidence Interval|Number
2758574|NCT00815295|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Sorafenib Administered With Cetuximab (400 mg/m2 Loading Dose Followed by 250 mg/m2 Weekly)|The MTD is based upon dose-limiting (DLTs) experienced during Cycle 1 of treatment. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience DLT. Using Common Toxicity Criteria for Adverse EVents (CTCAE) version 3.0, DLTs are defined as any Grade 4 hematologic toxicity, or Grade 3 or 4 non-hematologic toxicity. A DLT will not be considered to have occurred in the case of a grade 3 or 4 allergic reaction due to cetuximab.|Cycle 1 (28 Days)|All patients treated on either dose level 1 or 2 as part of the phase I study.|||mg|||Number
2758575|NCT00815191|Primary|Intraoperative Distal Esophageal (Core) Temperature||at 1 hour||||°C||Standard Error|Mean
2758576|NCT00815087|Secondary|Questionnaire of Life Quality||1 to 3 months|||||||
2758577|NCT00815087|Primary|The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months|A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.|Averaged 2 months||||cm/s||Standard Deviation|Mean
2758578|NCT00815035|Secondary|Incidence of All Serious Adverse Events During the Study|All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.|61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study.|The initial 10-11 months of the study were blinded. After unblinding, subjects completing the blinded phase continued on open label peanut OIT for the duration of the study.|||number of discrete SAE events|||Number
2758579|NCT00815035|Secondary|The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study|During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.|approximately 40 weeks (10 months)|Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not re-escalate for the purposes of this outcome.|||percentage of patients|||Number
2758580|NCT00815035|Secondary|The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut|The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.|first day of peanut OIT dosing|Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not repeat this 6 mg initial-day escalation.|||percentage of participants|||Number
2758581|NCT00815035|Secondary|The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.|Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.|60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy|Subjects completing 60 months of OIT treatment and completing the DBPCFC on the last day of treatment were analyzed.|||percentage of participants|||Number
2758582|NCT00815035|Primary|Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.|Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.|61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy|Subjects completing 60 months of OIT treatment, then passing the DBPCFC on the last day of treatment, then completing the DBPCFC after 1 month off of treatment were analyzed.|||percentage of participants|||Number
2758583|NCT00814983|Secondary|Rate of Immune Recovery|The time to recovery of T-cell subset, B cell and NK cell recovery will be monitored along with T-Cell proliferative response to mitogens.|3 years|No analysis was performed since the experimental arm was not opened||||||
2758584|NCT00814983|Primary|Disease Free Survival||One year|No analysis was performed since the experimental arm was not opened||||||
2758585|NCT00814983|Primary|The Incidence of Grade II-IV Acute Graft Versus Host Disease||One year from date of transplant|No analysis was performed since the experimental arm was not opened||||||
2758589|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.|24 Months|Intention-to-Treat|||percentage of participants|||Number
2758590|NCT00814970|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rate|Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758591|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.|12 Months|Intention-to-Treat (ITT)|||percentage of participants|Participants||Number
2758592|NCT00814970|Secondary|Change in Quality of Life - Decrease in Rutherford Class >= 1 Category|Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|30 Days|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758593|NCT00814970|Secondary|Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15|Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758594|NCT00814970|Secondary|Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category|Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|12 months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758595|NCT00814970|Secondary|Secondary Patency Rate|Defined as vessel patency resulting from any procedure that restores patency.|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758596|NCT00814970|Secondary|Assisted Primary Patency|Defined as vessel patency resulting from a procedure performed in the treated segment.|12 months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758597|NCT00814970|Secondary|Procedure Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.|At time of deployment to time of hospital discharge|Intention-to-Treat (ITT)|||percentage of lesions treated|||Number
2758598|NCT00814970|Secondary|Lesion Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)|||percentage of lesions treated|||Number
2758599|NCT00814970|Secondary|Device Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)|||percentage of lesions treated|||Number
2758600|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.|6 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758601|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.|30 days|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758602|NCT00814970|Primary|Primary Patency Rate|Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
2758603|NCT00814970|Primary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.|12 Months|Intent-to-Treat Population|||percentage of participants|||Number
2758604|NCT00814892|Secondary|Progression Free Survival (PFS)|PFS based on radiographic criteria was defined as the time from registration to the time of radiographic progression. A confirmed progression was defined as one for which radiological evidence of a new lesion is found following CT and/or bone scans.|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758605|NCT00814892|Secondary|Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire|"European Orgnisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 for cancer patients composed of 5 functional scales, 3 symptom scales, a global health status QOL scale, and six single items. Scores for each scale/item were calculated according to the questionnaire's scoring algorithm and range in 0 to 100, with high score represents high healthy level of functioning, high QOL or high level of symptomatology/problems. Change: Scores at cycle 1 minus scores at baseline.~Change from baseline in QOL will also be evaluated at cycle 6, 10, 15 and every 6 months during observation phase."|Baseline and cycle 1|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758606|NCT00814892|Secondary|Duration of PSA-based Response|"PSA-based response was defined as a PSA decline of at least 50%, which must be confirmed by a second PSA value in 4 or more weeks later.~The duration of PSA-based response are measured from the first time point at which the PSA has declined by at least 50% (which must eventually be confirmed by a second value) until PSA has increased back to 50% of the original on-study value."|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758607|NCT00814892|Secondary|Time to Prostate-specific Antigen (PSA) Progression|"In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value. In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.~The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved (see above). All end dates require a confirmatory PSA."|Registration to PSA progression (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758608|NCT00814892|Secondary|Time to Prostate-cancer Specific Mortality||Registration to Prostate-cancer specific mortality (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758609|NCT00814892|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 14 cycles)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758610|NCT00814892|Primary|Number of Participants Who Are Progression Free at One Year|Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level <200.0 ng/mL.|One year|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
2758611|NCT00814879|Secondary|Mean Change in Total Bilirubin (mg/dL) From Baseline|mean change in total bilirubin from baseline|baseline and 48 weeks||||mg/dL||Standard Deviation|Mean
2758612|NCT00814879|Secondary|Cholesterol|Total cholersterol (mg/dL)|baseline, week 24, week 48||||mg/dL||Standard Deviation|Mean
2758613|NCT00814879|Secondary|CD4+ Cell Count||Week 48||||cells/mm^3||Standard Deviation|Mean
2758614|NCT00814879|Secondary|CD4+ Cell Count||Weeks 24||||cells/mm^3||Standard Deviation|Mean
2758615|NCT00814879|Secondary|Number of Patients With < 400 Copies HIV RNA/mL at Week 48||48 weeks||||participants|||Number
2758616|NCT00814879|Primary|Number of Patients Reaching Virologic Failure at Week 48.|Virologic failure was defined by protocol as a plasma HIV RNA >50 c/mL on 2 consecutive occasions >7 days apart or > 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization).|48 Weeks||||participants|||Number
2758617|NCT00814801|Secondary|Change From Baseline in the Mental Function Impairment Scale (MENFIS)|MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment. This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
2758618|NCT00814801|Secondary|Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms. This four-point scale varies from 0 (=none) to 3 (= serious).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
2758619|NCT00814801|Secondary|Change From Baseline in the Disability Assessment for Dementia (DAD)|Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A. A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100. Items rated as Not Applicable (N/A) are not considered for the total score. The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL). Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
2758620|NCT00814801|Primary|Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from markedly improved to markedly worse."|24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||patients|||Number
2758621|NCT00814801|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
2758622|NCT00814788|Secondary|Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Up to 3 years||||months||95% Confidence Interval|Median
2758623|NCT00814788|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years||||months||95% Confidence Interval|Median
2758624|NCT00814788|Primary|PSA Response Rate|The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.|Up to 2 years||||Participants|||Count of Participants
2758625|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy||60 seconds||||seconds||Inter-Quartile Range|Median
2758627|NCT00814710|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following first vaccination (Month 0) throughout the entire study period (month 3)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2758628|NCT00814710|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms"|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2758629|NCT00814710|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. However, the total number of subjects analyzed in this Total Vaccinated cohort included all subjects having returned their symptom sheets.|||subjects|||Number
2758630|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)|Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758631|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)|"Seroprotection was defined as:~Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758632|NCT00814710|Secondary|Number of Subjects Seropostive for B. Pertussis|Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758633|NCT00814710|Secondary|Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).|Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||mIU/mL||95% Confidence Interval|Geometric Mean
2758634|NCT00814710|Secondary|Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)|Concentration was expressed as GMC in EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2758635|NCT00814710|Secondary|Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)|Concentrations were expressed as GMCs in international units per milliliter (IU/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||IU/mL||95% Confidence Interval|Geometric Mean
2758636|NCT00814710|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentration is expressed as GMC in µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||µg/mL||95% Confidence Interval|Geometric Mean
2758637|NCT00814710|Secondary|Number of Subjects Seropositive for Protein D (PD)|Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758638|NCT00814710|Secondary|Number of Subjects Seropositive for Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.~Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL"|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758639|NCT00814710|Secondary|Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes|Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||µg/mL||95% Confidence Interval|Geometric Mean
2758640|NCT00814710|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.~The cut-off was defined as 0.20 microgram per milliliter (µg/mL)."|One month after primary immunization|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758666|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758641|NCT00814710|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Cross-reactive pneumococcal serotypes included 6A and 19A.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
2758642|NCT00814710|Primary|Concentration of Antibody Against Protein D (PD)|Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2758643|NCT00814710|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).~Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||µg/mL||95% Confidence Interval|Geometric Mean
2758644|NCT00814697|Primary|Cognitive Assessment Task Scores Before, During and After rTMS.|"Cognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS.~Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed.~Total possible score ranges by test, lowest to highest:~BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments."|6 weeks||||units on a scale||Full Range|Mean
2758645|NCT00814671|Secondary|Pharmacokinetics of Rifapentine|area under the concentration time curve (AUC[0-24]) for rifapentine administered once daily at doses of 450 mg or 600 mg in the context of multi drug intensive phase TB treatment|8 weeks||||ug x h/ml||Inter-Quartile Range|Median
2758646|NCT00814671|Secondary|Time to Stable Culture Conversion on Liquid MGIT Media|Time (in days) to stable culture conversion on liquid MGIT media|12 weeks||||days||Inter-Quartile Range|Median
2758647|NCT00814671|Secondary|Time to Stable Culture Conversion on Solid Medium|Time to stable culture conversion (in days) on Lowenstein Jensen solid medium|12 weeks|Data was not collected on some participants due to loss to follow up|||days||Inter-Quartile Range|Median
2758648|NCT00814671|Primary|Tolerability|percentage of participants discontinuing assigned treatment|10 weeks|safety analysis population|||percentage of participants|||Number
2758649|NCT00814671|Primary|Percentage of Participants With Negative Lowenstein Jensen Cultures at Week 8||8 weeks|per protocol|||percentage of participants w/LJ cx con|||Number
2758650|NCT00814658|Secondary|The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24|The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2758651|NCT00814658|Secondary|The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24|The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Week 4, Week 8, Week 16, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||participants|||Number
2758652|NCT00814658|Secondary|The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2758653|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2758654|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2758655|NCT00814658|Primary|The Quality of Life Assessment for Caregivers of Patients With Alzheimer's Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for caregivers of patients with Alzheimer's disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2758656|NCT00814658|Primary|Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24|The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient's reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
2758657|NCT00814658|Primary|Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24|The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
2758658|NCT00814658|Primary|Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24|The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient's right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
2758659|NCT00814658|Primary|Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24|The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient's finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
2758660|NCT00814632|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks||||participants|||Number
2758661|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758662|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758663|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758664|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758665|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758667|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758668|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758669|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758670|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758671|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758672|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758673|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758674|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
2758675|NCT00814580|Secondary|Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population|||Number of participants|||Number
2758676|NCT00814580|Secondary|Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population|||Number of calls|||Number
2758677|NCT00814580|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population|||percentage of participants|||Number
2758678|NCT00814580|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population|||percentage of participants|||Number
2758679|NCT00814580|Secondary|Subject Satisfaction With Treatment|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied|7 Days|Intent-to-Treat Population|||percentage of participants|||Number
2758680|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758681|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758682|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758683|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758684|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758685|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758686|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758687|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758688|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 7|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population|||percentage of participants|||Number
2758689|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 3|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population|||percentage of participants|||Number
2758690|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 7|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population|||percentage of participants|||Number
2758691|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 3|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population|||percentage of participants|||Number
2758692|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population|||Hours||95% Confidence Interval|Median
2758763|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE At Any Time During the Study|Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
2758693|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population|||Hours||95% Confidence Interval|Median
2758694|NCT00814580|Primary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
2758695|NCT00814502|Secondary|Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms|"Rating Scale for Aggressive Behavior in the Elderly (RAGE, 0-61); higher is worse.~Disruptive Behavior Rating Scales (DBRS, 0-105); higher is worse.~Neuropsychiatric Inventory (NPI, 0-144) - measures 12 different domains of neuropsychiatric symptoms such as delusions, hallucinations, anxiety, depression, apathy, etc.; higher is worse.~Montgomery-Asberg Depression Rating Scale (MADRS, 0-90); higher is worse.~Mini-mental state examination (MMSE, 0-30); higher is better.~The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the firs"|post-intervention, up to 3 weeks||||units on a scale||Standard Error|Least Squares Mean
2758696|NCT00814502|Primary|Sleep Minutes|"Total sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep.~The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data."|post-intervention, up to 3 weeks||||sleep minutes||Standard Error|Least Squares Mean
2758697|NCT00814502|Primary|Sleep Efficiency|"Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100*sleep minutes)/[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)].~The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data."|Post-intervention, up to 3 weeks||||percentage of sleep (see above)||Standard Error|Least Squares Mean
2758698|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|"The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations:~C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17)."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.|||T-cells/million cells||Standard Deviation|Mean
2758699|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|"The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations:~Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.|||T-cells/million cells||Standard Deviation|Mean
2758700|NCT00814489|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)|Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.|Days 0, 30, 60, 90, 180 and 420.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.|||LU/mL||95% Confidence Interval|Geometric Mean
2758727|NCT00814346|Secondary|Change in Cognitive Tests-GDS Score in MC and CNE Groups|"The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By yes or no answers, scores permit to classify patients into groups of severely depressed (score of 21 to 30), moderately depressed (score of 11 to 20) and normal (score of 0 to10). It takes10 to 15 minutes to administer."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||GDS Score||Full Range|Median
2758701|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.~This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2758702|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.~This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2758703|NCT00814489|Primary|Number of Subjects With Any Biochemical Laboratory Abnormalities|"Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE).~Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2758704|NCT00814489|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 420|The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.|||Subjects|||Number
2758705|NCT00814489|Primary|Number of Subjects With Any Unsolicited Adverse Events (AE)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|During a 30-day (Days 0-29) follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2758706|NCT00814489|Primary|Number of Subjects With Any Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade.~Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination."|During a 7-day follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2758707|NCT00814463|Secondary|Overall Survival||12 months|Data not collected due to subject withdrawal.||||||
2758708|NCT00814463|Secondary|Rate of Death Due to Neurologic Causes||12 months|Data not collected due to subject withdrawal.||||||
2758709|NCT00814463|Secondary|Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)||12 months|Data not collected due to subject withdrawal.||||||
2758710|NCT00814463|Secondary|Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam||Every 3 months for 12 months.|Data not collected due to subject withdrawal.||||||
2758711|NCT00814463|Secondary|Quality of Life as Measured by the FACT-Br Subscales||Every 3 months for 12 months|Data not collected due to subject withdrawal.||||||
2758712|NCT00814463|Secondary|Rate of New Brain Metastases Outside of the Adjuvant SRS Site||12 months|Data not collected due to subject withdrawal.||||||
2758713|NCT00814463|Secondary|Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery||12 months||||Participants|||Count of Participants
2758714|NCT00814463|Primary|Recurrence Rate at the Surgical Site as Measured by MRI|The number of months for local recurrence via MRI|12 months||||Months|||Number
2758715|NCT00814346|Secondary|Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size|Evolution of brain morphology (degree of cortical atrophy) after 18 months with EGb761, using MRI voxel based morphometry|From Baseline (Month 0) to Month 18|ITT population.|||mm3||Full Range|Median
2758716|NCT00814346|Secondary|Incidence of Adverse Events (AEs)|"The relationship of an adverse event to the study medication will be classified according to the following criteria:~Related : reports including good reasons and sufficient information (e.g. temporal relationship, dose-response relationship, pharmacology, positive de-challenge and/or re-challenge) to assume a causal relationship with the study drug in the sense that it is plausible, conceivable, or likely~Not related: reports including good reasons and sufficient information (e.g. no temporal relationship and/or attributable to concurrent disease or other drugs) to rule out a causal relationship with the study drug."|Up to Month 18|Safety population. CNE patients withdrew during the double-blind phase and were also not included in the safety population for open phase (17 months).|||participants|||Number
2758923|NCT00813761|Primary|Frequency of Eye Burning/Stinging|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
2758717|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer's)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 18|ITT population. N=Number of subjects with assessment.|||participants|||Number
2758718|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.|At Month 18|ITT population. N=Number of subjects with assessment.|||participants|||Number
2758719|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.~First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Seconds||Full Range|Median
2758720|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.~Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
2758721|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.~Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
2758722|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.~Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.~Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.~Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Recall score||Full Range|Median
2758723|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.~The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Cube drawing test score||Full Range|Median
2758724|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Clock drawing test score||Full Range|Median
2758725|NCT00814346|Secondary|Change in Cognitive Tests-MMSE Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||MMSE Score||Full Range|Median
2758726|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.~Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.~Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Number of good answers||Full Range|Median
2761509|NCT00795951|Primary|Diagnostic Performance: Imidazolidinyl Urea|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2758728|NCT00814346|Secondary|Change in Cognitive Tests-CDR Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3)|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||CDR overall score||Full Range|Median
2758729|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer's)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 9|ITT population. N=Number of subjects with assessment.|||participants|||Number
2758730|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer's Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|"The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.~National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)"|At Month 9|ITT population. N=Number of subjects with assessment|||participants|||Number
2758731|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.~First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.~The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Seconds||Full Range|Median
2758732|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.~Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
2758733|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.~Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
2758734|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT)|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.~Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.~Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.~Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Recall score||Full Range|Median
2758735|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.~The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Cube drawing test score||Full Range|Median
2758736|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Clock drawing test score||Full Range|Median
2758737|NCT00814346|Secondary|Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||MMSE Score||Full Range|Median
2758943|NCT00813748|Primary|Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants||Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||minutes||Full Range|Median
2758738|NCT00814346|Primary|Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)|"Following statistical parametric mapping (SPM) analyses were performed by the Commissariat à l'Energie Atomique (CEA):~The comparison between treatment groups separately for each group of elderly subjects (CNE and MC groups only)~The comparison between the two groups of elderly subjects (CNE and MC groups only) by treatment group~FDG PET demonstrates reductions in the cerebral glucose metabolism that may occur a few years before the overt clinical manifestation of disease.~SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]~BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80~Standardized Uptake Value (SUV) Body Surface Area (BSA)"|From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase|Intention to treat (ITT) population: All treated CNE and MC patients|||SUVBSA2||Full Range|Median
2758739|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.~Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.~Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Number of good answers||Full Range|Median
2758740|NCT00814346|Secondary|Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups|"The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By yes or no answers, scores permit to classify patients into groups of severely depressed (score of 21 to 30), moderately depressed (score of 11 to 20) and normal (score of 0 to10). It takes10 to 15 minutes to administer."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||GDS Score||Full Range|Median
2758741|NCT00814346|Secondary|Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3).|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||CDR overall score||Full Range|Median
2758742|NCT00814346|Secondary|Change in Brain Glucose Metabolism in the MC and CNE Groups|"Brain glucose metabolism measured by 18FDG PET~SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]~BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80"|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||SUVBSA2||Full Range|Median
2758743|NCT00814333|Primary|Cessation of Epistaxis||baseline, day 4-6|No participants started treatment on this study. Study was closed before any study related procedures were administered.||||||
2758744|NCT00814320|Secondary|Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)||||Percentage of participants|||Number
2758745|NCT00814320|Secondary|Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)||||Number of participants|||Number
2758746|NCT00814320|Secondary|Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of participants|||Number
2758747|NCT00814320|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set|||Number of participants|||Number
2758748|NCT00814320|Secondary|Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion|"Temporally associated defined as during infusion or within 72 hours of completion of infusion.~Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]).~Expressed as a percentage."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of AE|Infusions|95% Confidence Interval|Median
2758749|NCT00814320|Secondary|Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)|"Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%.~The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
2758750|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs|"Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, [administered via intravenous (IV) or subcutaneous (SC) route], recombinant human hyaluronidase (rHuPH20) or both.~The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
2758751|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant|||Number
2758752|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant|||Number
2758753|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant|||Number
2758754|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2758755|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2758756|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
2758757|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs|||Number
2758758|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs|||Number
2758759|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs|||Number
2758760|NCT00814320|Secondary|Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)|Frequency of dose corrections based on immune globulin G (IgG) trough levels <4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of participants|||Number
2758761|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of infusions|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions|95% Confidence Interval|Median
2758762|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of participants|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant||95% Confidence Interval|Median
2758764|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
2758765|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study|Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study|At any time during the study|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
2758766|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of IV and SC (with recombinant human hyaluronidase [rHuPH20]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
2758767|NCT00814320|Secondary|Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Participants exposed to either or both study drugs|||Percentage of participants|||Number
2758768|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
2758769|NCT00814320|Secondary|Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site|"Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site.~An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion."|During infusion or within 60 minutes of completion of the infusion|Safety Analysis Data Set|||Percentage of infusions||95% Confidence Interval|Median
2758770|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion|"Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
2758771|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|"Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
2758772|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated AEs|"Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions||Number
2758773|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated AEs|"Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
2758774|NCT00814320|Secondary|Rate of Temporally Associated AEs Per Infusion|"Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set (SADS)|||Number of AEs per infusion|Infusions|95% Confidence Interval|Median
2758775|NCT00814320|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).~IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions"|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of infusions|Infusions||Number
2758776|NCT00814320|Secondary|Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).~An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of participants|||Number
2758777|NCT00814320|Secondary|Rate of Days in Hospital|"Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Days per month||95% Confidence Interval|Number
2758778|NCT00814320|Secondary|Rate of Acute Physician Visits|"Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Visits per month||95% Confidence Interval|Number
2758779|NCT00814320|Secondary|Rate of Days on Antibiotics|"Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Days on antibiotics per month||95% Confidence Interval|Number
2758780|NCT00814320|Secondary|Rate of Days Off School or Work|"Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Days off per month||95% Confidence Interval|Number
2758781|NCT00814320|Secondary|Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
2758782|NCT00814320|Secondary|H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
2758783|NCT00814320|Secondary|H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||μg/mL||95% Confidence Interval|Median
2758816|NCT00814307|Secondary|Number of Hours Per Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||hours per day||Standard Deviation|Mean
2758784|NCT00814320|Secondary|H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||L/kg/day||95% Confidence Interval|Median
2758785|NCT00814320|Secondary|H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||μg*days/mL||95% Confidence Interval|Median
2758786|NCT00814320|Secondary|H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||μg/mL||95% Confidence Interval|Median
2758787|NCT00814320|Secondary|Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
2758788|NCT00814320|Secondary|Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||IU/mL||95% Confidence Interval|Median
2758789|NCT00814320|Secondary|Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
2758790|NCT00814320|Secondary|Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||nL/IU/day||95% Confidence Interval|Median
2758791|NCT00814320|Secondary|Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||IU*days/mL||95% Confidence Interval|Median
2758792|NCT00814320|Secondary|Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||IU/mL||95% Confidence Interval|Median
2758793|NCT00814320|Secondary|Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
2758794|NCT00814320|Secondary|IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
2758795|NCT00814320|Secondary|IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||g/L||95% Confidence Interval|Median
2758796|NCT00814320|Secondary|IgG Clearance (CL) for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||mL/kg/day||95% Confidence Interval|Median
2758797|NCT00814320|Secondary|IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||g*days/L||95% Confidence Interval|Median
2758870|NCT00814138|Secondary|MG-ADL 12 Month Change|The MG-ADL is an 8 item scale developed to assess myasthenia gravis symptoms. Score will range from 0 (normal - no MG symptoms) to 24 (severe MG symptoms)|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
2758798|NCT00814320|Secondary|IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||g/L||95% Confidence Interval|Median
2758799|NCT00814320|Secondary|Antibody Levels to Hepatitis B|Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results|||mIU/mL||95% Confidence Interval|Median
2758800|NCT00814320|Secondary|Antibody Levels to Measles|Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results|||Titer||95% Confidence Interval|Median
2758801|NCT00814320|Secondary|Antibody Levels to Haemophilus Influenzae|Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results|||μg/mL||95% Confidence Interval|Median
2758802|NCT00814320|Secondary|Antibody Levels to Tetanus (Clostridium Tetani Toxoid)|Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results|||IU/mL||95% Confidence Interval|Median
2758803|NCT00814320|Secondary|Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)|IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit|Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements|||mg/dL||95% Confidence Interval|Median
2758804|NCT00814320|Secondary|Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.|Full Analysis Data Set|||g/L||95% Confidence Interval|Median
2758805|NCT00814320|Secondary|Annual Rate of All Infections Per Participant|"Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint."|Throughout the study period (17 months)|Full Analysis Data Set|||Estimated infections/year||95% Confidence Interval|Number
2758806|NCT00814320|Secondary|Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20|"Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20.~Expressed as a percentage.~This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B):~Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies)."|PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.|Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration|||Percentage||90% Confidence Interval|Number
2758904|NCT00813813|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
2758807|NCT00814320|Secondary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit|Participants aged 2 to < 12 years exposed to either or both study drugs with available IgG trough level measurements|||Percentage||95% Confidence Interval|Number
2758808|NCT00814320|Secondary|Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Percentage||90% Confidence Interval|Number
2758809|NCT00814320|Primary|Validated Acute Serious Bacterial Infection (VASBI) Rate|"Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen.~VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only.~The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant."|Throughout the study period (17 months)||||Estimated infections/year|||Number
2758810|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively.|||units on a scale||Standard Deviation|Mean
2758811|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758812|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
2758813|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
2758814|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2758815|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758905|NCT00813813|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
2758817|NCT00814307|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||hours per day||Standard Deviation|Mean
2758818|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||days||Standard Deviation|Mean
2758819|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||days||Standard Deviation|Mean
2758820|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||events||Standard Deviation|Mean
2758821|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||events||Standard Deviation|Mean
2758822|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758823|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758824|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2758825|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2761510|NCT00795951|Primary|Diagnostic Performance: Diazolidinyl Urea|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2758826|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2758827|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758828|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2758829|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2758830|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 3|FAS population. 'n'=participants evaluable at given time point for each group respectively.|||participants|||Number
2758831|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758832|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2758833|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758834|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
2758835|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
2758836|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
2758837|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
2758838|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Month 4, 5 and 6|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
2758839|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
2758840|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758841|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758842|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758843|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758844|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2761511|NCT00795951|Primary|Diagnostic Performance: Thiuram Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2758845|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3|FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2758846|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758847|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758848|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758849|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758850|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758851|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 2|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758852|NCT00814307|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2758920|NCT00813761|Primary|Average Corneal Fluorescein Type Staining|staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|Eyes|Standard Error|Least Squares Mean
2758853|NCT00814307|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2758854|NCT00814307|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 3|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of participants|||Number
2758855|NCT00814255|Secondary|Percent Change in or Time to Doubling of Serum Creatinine||Baseline and 6 months|No data were collected.||||||
2758856|NCT00814255|Secondary|Percent Change in Proteinuria||Baseline and 6 months|No data were collected.||||||
2758857|NCT00814255|Secondary|Number of Participants With Adverse Events||Up to 7 months||||participants|||Number
2758858|NCT00814255|Secondary|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Baseline and 6 months|No data were collected.||||||
2758859|NCT00814255|Primary|Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients|Number of participants with a reduction in proteinuria at 6 months by > 50% of the value at screening AND stable GFR defined as greater than 75 ml/min/1.73m2 in those with an initial value above 90 OR within 25% of baseline for remaining patients.|baseline and 6 months|One participant was assigned to the rosiglitazone arm before the drug was replaced with the galactose arm. This participant was not included in the analysis.|||participants|||Number
2758860|NCT00814177|Primary|Number of Patients With Prothrombin Time Results Within the Therapeutic Range After 2 Weeks|"The number of patients with follow-up INRs within the therapeutic range was compared for patients with a single dose skipped/reduced/added versus patients with no change of dose."|2 weeks||||participants|||Number
2758861|NCT00814164|Secondary|A Preliminary Relationship Between Treatment Outcome and Biologic Parameters||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
2758862|NCT00814164|Secondary|Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
2758863|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
2758864|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
2758865|NCT00814164|Secondary|Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
2758866|NCT00814164|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|4 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2758867|NCT00814164|Secondary|Disease-free Survival|Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.|5 years|All treated and eligible patients who had first objective documentation of CR or CRp.|||months||95% Confidence Interval|Median
2758868|NCT00814164|Primary|Complete Remission (CR)|Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).|2 years|All treated and eligible patients|||percentage of participant||95% Confidence Interval|Number
2758869|NCT00814138|Secondary|MG Composite Change Over 12 Months|This scale is composed of components of the QMG, MG-ADL and the MMT. These components have been shown to be the most responsive in previous clinical trials. Each item in the QMG, MG-ADL and the MMT was weighed (Rasch analysis performed) and then assigned a score. Score would range from 0 (no effects from the myasthenia gravis) to a score of 50. A participant with a score of 50 wwould be in the hospital on a ventilator.|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
2761512|NCT00795951|Primary|Diagnostic Performance: Thimerosal|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2758871|NCT00814138|Secondary|MGQOL 12 Month Change|This test is a 15 item patient-reported scale indicating how myasthenia gravis affects the quality of life. Each item is graded as how true each statement has been over the past 7 days. The scale is 0=Not at all, 1= a little bit, 2= somewhat, 3= quite a bit and 4= very much. The numbers are then added to produce a total score. The MGQOL score would range from 0 (no MG symptoms that affected their quality of life) to a score of 60 (MG symptoms affected they quality of life very much).|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
2758872|NCT00814138|Secondary|Manual Muscle Testing 12 Month Change|This measurement was developed to measure the strength of muscle groups in the face, neck, arms and legs. Measurement is made by grading the amount of weakness. Participants are graded as having normal, mild (25%) weakness, moderate (50%) weakness or severe (75%) weakness and 4 = paralyzed/unable to do. Normal would receive a score of 0, mild would receive a score of 1, moderate would receive a score of 2, severe would receive a score of 3 and unable to perform would receive a score of 4. Range would be from 0 (no weakness) to 76 (complete paralysis).|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
2758873|NCT00814138|Secondary|Quantitative Myasthenia Gravis (QMG) Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The scale is from 0 - 3 for each item, with 0 meaning normal and 3 is severe. Total score can range from 0 to 39.|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
2758874|NCT00814138|Secondary|Average Prednisone Daily Dose (mg/Day)|Participants were asked to fill out the amount of prednisone they took every day on a paper diary.|Total length of time daily dose information was collected, i.e. 9 months.||||mg/day||95% Confidence Interval|Mean
2758875|NCT00814138|Primary|Total Prednisone Dose Area Under the Curve|The primary outcome measure was the nine-month prednisone area under the dose-time curve (AUDTC, months 4-12). The AUDTC was chosen because it accounted for changes in the prednisone dose that could occur frequently during a month.|9 months|Myasthenia Gravis patients aged 18 and older that were acetylcholine antibody positive with a myasthenia gravis foundation score of Grade II, III or IV.|||mg*Months||95% Confidence Interval|Number
2758876|NCT00813995|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2758877|NCT00813995|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2758878|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||Percent||95% Confidence Interval|Least Squares Mean
2758879|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||Percent||95% Confidence Interval|Least Squares Mean
2758880|NCT00813995|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||Percent||95% Confidence Interval|Least Squares Mean
2758881|NCT00813982|Primary|Overall Vision|Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.|||Units on a Scale||Standard Deviation|Mean
2758882|NCT00813943|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section||||||
2758891|NCT00813943|Secondary|Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)|The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hours||Standard Deviation|Mean
2758921|NCT00813761|Primary|Frequency of Tearing|Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
2758883|NCT00813943|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
2758884|NCT00813943|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
2758885|NCT00813943|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss)|The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||liter||Standard Deviation|Mean
2758886|NCT00813943|Secondary|Plasma Clearance (CL)|The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||milliliter per minute||Standard Deviation|Mean
2758887|NCT00813943|Secondary|Mean Residence Time From Time 0 to Infinity (MRT [0-infinity])|The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hour||Standard Deviation|Mean
2758888|NCT00813943|Secondary|Apparent Terminal Rate Constant|The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||per hour||Standard Deviation|Mean
2758889|NCT00813943|Secondary|Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)|The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. One participant had implausible pre-dose concentration."|||ng/mL||Standard Deviation|Mean
2758890|NCT00813943|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])|The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hour*ng/mL||Standard Deviation|Mean
2758922|NCT00813761|Primary|Frequency of Itching|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
2758892|NCT00813943|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2758893|NCT00813943|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2758894|NCT00813943|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2758895|NCT00813917|Primary|7-day Point Prevalence All Tobacco Abstinence|7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml|12 weeks - end of treatment||||participants|||Number
2758896|NCT00813904|Secondary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.|Baseline to Day 29, continuously|All participants who received treatment with rThrombin.|||Participants|||Number
2758897|NCT00813904|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation|An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline through Day 29, continuously|All participants who received treatment with rThrombin.|||Participants|||Number
2758898|NCT00813904|Primary|Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29|Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.|At baseline and Day 29|Participants who received treatment with rThrombin and had data available from both baseline and Day 29 antibody assessments.|||Participants|||Number
2758899|NCT00813865|Secondary|Change From Baseline To EOT In Volume Of Liver As Assessed By MRI|Standard MRI procedures were used to measure the volume of the liver. The baseline value was defined as the value recorded on Days 1 to 3 of the study (certain values could have been carried over from the last assessment in the lead-in study, GAU-CL-202). A negative change from Baseline indicates that liver volume decreased.|Baseline, Month 30|PD Population: all participants in the Safety Population who had a baseline and at least 1 post-baseline PD measurement. Seven of 8 participants did not complete the study and did not contribute data to this endpoint.|||cm^3|||Number
2758900|NCT00813865|Secondary|Change From Baseline To EOT In Volume Of Spleen As Assessed By Magnetic Resonance Imaging (MRI)|Standard MRI procedures were used to measure the volume of the spleen. The baseline value was defined as the value recorded on Days 1 to 3 of the study (certain values could have been carried over from the last assessment in the lead-in study, GAU-CL-202). A negative change from Baseline indicates that spleen volume decreased.|Baseline, Month 30|PD Population: all participants in the Safety Population who had a baseline and at least 1 post-baseline PD measurement. Seven of 8 participants did not complete the study and did not contribute data to this endpoint.|||cubic centimeters (cm^3)|||Number
2758901|NCT00813865|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through the end of follow-up is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through end of follow-up (6 months after EOT)|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2758902|NCT00813813|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population|||units on a scale||Standard Deviation|Mean
2758903|NCT00813813|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population|||units on a scale||Standard Deviation|Mean
2758906|NCT00813813|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
2758907|NCT00813813|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|Safety Population|||participants|||Number
2758908|NCT00813800|Secondary|Young Mania Rating Scale (YMRS) at 12 Weeks|YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.|12 weeks|Intention to Treat (ITT)|||Units on a Scale||Standard Deviation|Mean
2758909|NCT00813800|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks|MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.|12 weeks|Intention to Treat (ITT)|||Units on a Scale||Standard Deviation|Mean
2758910|NCT00813800|Primary|Carbon Monoxide Breath Level at 12 Weeks|Measured by expired breath in parts per million (ppm)|12 weeks|Intention to Treat (ITT)|||ppm||Standard Deviation|Mean
2758911|NCT00813761|Secondary|Physiological Responses|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale)."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification.|||units on a scale||Standard Deviation|Least Squares Mean
2758912|NCT00813761|Secondary|Wearing Time and Comfortable Wearing Time|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Average wearing time and average comfortable wearing time."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.|||hours||Standard Deviation|Least Squares Mean
2758913|NCT00813761|Secondary|Intensity of Physiological Outcomes|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to Solution Induced Corneal Staining (SICS). These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.|||units on a scale||Standard Deviation|Least Squares Mean
2758914|NCT00813761|Primary|Tarsal Roughness|The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
2758915|NCT00813761|Primary|Upper Tarsal Redness|Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
2758916|NCT00813761|Primary|Lower Tarsal Redness|Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
2758917|NCT00813761|Primary|Bulbar Redness|Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
2758918|NCT00813761|Primary|Limbal Redness|Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
2758919|NCT00813761|Primary|Average Corneal Fluorescein Staining Area|corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|Eyes|Standard Error|Least Squares Mean
2758924|NCT00813761|Primary|Frequency of Daily Lens Dryness|Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
2758925|NCT00813761|Primary|Frequency of Eye Discomfort|Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
2758926|NCT00813761|Primary|Lens Comfort|Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
2758927|NCT00813761|Primary|Average Daily Comfortable Wear Time|Average hours per day that contact lens were worn comfortably.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||Hours||Standard Error|Least Squares Mean
2758928|NCT00813761|Primary|Average Daily Wear Time|Average hours per day that contact lens were worn.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||Hours||Standard Error|Least Squares Mean
2758929|NCT00813748|Primary|Number of Participants With ATA - Skin Testing Substudy|Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.|Substudy Week 10|Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
2758930|NCT00813748|Primary|Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy||Substudy Day 1|Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded.|||participants|||Number
2758931|NCT00813748|Primary|Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study|Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
2758932|NCT00813748|Primary|Medications Within Two Weeks Prior to Blood Draw|Number of participants in each medication class is reported. Participants could have received more than 1 medication class.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758933|NCT00813748|Primary|Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants|Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758934|NCT00813748|Primary|Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants|Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
2758935|NCT00813748|Primary|Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants||Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758936|NCT00813748|Primary|Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants|Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
2758937|NCT00813748|Primary|Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants||Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758938|NCT00813748|Primary|Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants||Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758939|NCT00813748|Primary|Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants|Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758940|NCT00813748|Primary|Treatment Received Following Adjudicated Anaphylactic Event - Case Participants|Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758941|NCT00813748|Primary|Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants|Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758942|NCT00813748|Primary|Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants|Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758944|NCT00813748|Primary|Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants|Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
2758945|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 60|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2758946|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 60|BAbs are all antibodies which are capable of binding to the RNF irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA.|Month 60|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||participants|||Number
2758947|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 60|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Z-score||Standard Deviation|Mean
2758948|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 60|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 60 was calculated as EDSS score at Month 60 minus EDSS score at baseline.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2758949|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 60|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||percentage of participants|||Number
2758950|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 60|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from '0-60'. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2758951|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) at Month 60|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||percentage of participants|||Number
2758952|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 60|Percent Change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||percent change||Standard Deviation|Mean
2758953|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Volume, and Time Constant 2 (T2) Lesion Volume at Month 60|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||mm^3||Standard Deviation|Mean
2758954|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New T1 Lesions Per Participant Per Scan at Month 60|Number of CUA lesions, new T2 lesions, new Gd+ Lesions and new T1 lesions were measured by using MRI scans.|Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||lesions||Standard Deviation|Mean
2758955|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 60 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||% of participants with EDSS progression|||Number
2758956|NCT00813709|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to Month 60|CDMS was defined by the occurrence of a second attack or relapse over 60 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||Cumulative % of participants with CDMS||95% Confidence Interval|Number
2758957|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 36 (DB treatment period for study 28981 (REFLEXION)|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2758958|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 36|BAbs are all antibodies which are capable of binding to the investigational drug molecule (RNF) irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA (Enzyme-linked immunosorbent assay).|Month 36|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||participants|||Number
2758959|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 36|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Z-score||Standard Deviation|Mean
2758960|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 36 was calculated as EDSS score at Month 36 minus EDSS score at baseline.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2758961|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 36|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||Percentage of participants|||Number
2759046|NCT00812981|Secondary|Number of Subjects With Any AESIs|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2758962|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 36|The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from '0-60'. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
2758963|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) up to 36 Months|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Baseline (Day 1 of Study 27025) up to CDMS conversion and/or up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||percentage of participants|||Number
2758964|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 36|Percent change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||percent change||Standard Deviation|Mean
2758965|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Lesion Volume and Time Constant 2 (T2) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions at Month 36|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||cubic millimeter (mm^3)||Standard Deviation|Mean
2758966|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Lesions Per Participant Per Scan at Month 36|Number of CUA lesions, new T2 lesions, new Gd+ lesions and new T1 lesions were measured by using MRI scans.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||lesions||Standard Deviation|Mean
2758967|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 36 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||% of participants with EDSS progression|||Number
2758968|NCT00813709|Primary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months|CDMS was defined by the occurrence of a second attack or relapse over 36 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||Cumulative % of participants with CDMS||95% Confidence Interval|Number
2758969|NCT00813592|Secondary|To Characterize the Safety and Tolerability of SOM230|Number of participants to experience adverse events|Monthly from study entry until subject taken off study, average 28 months||||participants|||Number
2758970|NCT00813592|Secondary|To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230||November 2011|||||||
2758971|NCT00813592|Secondary|To Establish the Median PFS and Overall Survival (OS)||November 2011|||||||
2758972|NCT00813592|Secondary|To Establish the 6-month Progression-free Survival Rate||November 2011|||||||
2758973|NCT00813592|Secondary|To Determine the Duration of Response to SOM230||November 2011|||||||
2758974|NCT00813592|Primary|Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma|Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.|November 2011|||||||
2758975|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC)Endpoint|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|End of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
2759329|NCT00811317|Secondary|Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data||24 hours|Navigator CGM data from the day prior to admission was not obtained||||||
2758976|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period."|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
2758977|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.~The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|Two months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
2758978|NCT00813488|Secondary|Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period."|One month after start of open-label extension|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Unit on a scale||Standard Deviation|Mean
2758979|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) Endpoint|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period.|At conclusion of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
2758980|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period.|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on scale||Standard Deviation|Mean
2758981|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period.|2 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on scale||Standard Deviation|Mean
2758982|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period.|One month after start of open-label treatment|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Unit on a scale||Standard Deviation|Mean
2758983|NCT00813488|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.|Double-blind safety analysis set: 143 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment|||Participants|||Number
2759047|NCT00812981|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to 51 days after the first vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2759330|NCT00811317|Secondary|Blood Glucagon Levels||24 hours||||microgram/kg||Standard Deviation|Mean
2758984|NCT00813488|Secondary|Medication Performance Assessment 60 Minutes Post-treatment|"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded."|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Episodes|Participants||Number
2758985|NCT00813488|Secondary|Medication Performance Assessment 30 Minutes Post-treatment|"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded."|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Episodes|Participants||Number
2758986|NCT00813488|Secondary|Use of Standard Rescue Medication|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|Throughout the double-blind treatment period|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Episodes|Participants||Number
2758987|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758988|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758989|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758990|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2759061|NCT00812968|Secondary|Change From Baseline in Percentage of Bone Marrow Erythroblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|Efficacy population with available bone marrow specimens.|||Percentage of Bone Marrow Erythroblasts||Full Range|Median
2759331|NCT00811317|Secondary|Total Glucagon Dose||24 hours||||mcg/kg||Standard Deviation|Mean
2758991|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758992|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes|Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758993|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=60 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758994|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=45 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758995|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=30 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758996|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=15 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758997|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=10 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2759332|NCT00811317|Secondary|Glucagon T-max|Time to maximum peak glucagon concentration|24 hours||||minutes||Standard Deviation|Mean
2759333|NCT00811317|Secondary|Total Insulin Dose||24 hours||||u/kg||Standard Deviation|Mean
2758998|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
2758999|NCT00813488|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Percentage change||Standard Deviation|Mean
2759000|NCT00813488|Secondary|Total Pain Relief at 60 Minutes (TOTPAR60)|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||units on a scale|Participants|Standard Error|Least Squares Mean
2759001|NCT00813488|Secondary|Pain Relief Score at 60 Minutes Post-treatment|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2759002|NCT00813488|Secondary|Pain Relief Score at 45 Minutes Post-treatment|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2759003|NCT00813488|Secondary|Pain Relief Score at 30 Minutes Post-treatment|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2759004|NCT00813488|Secondary|Pain Relief Score at 15 Minutes Post-treatment|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2759005|NCT00813488|Secondary|Pain Relief Score at 10 Minutes Post-treatment|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2759006|NCT00813488|Secondary|Pain Relief (PR) Score at 5 Minutes Post-treatment|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|5 minutes after treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2759007|NCT00813488|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759008|NCT00813488|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759009|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
2759010|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
2759011|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
2759012|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment|Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Baseline (immediately pre-dose) and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
2759013|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period.|Immediately before treatment and 10 minutes after treatment.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
2759334|NCT00811317|Secondary|Percentage of Time Spent With BG > 180 mg/dl||24 hours||||percentage of time||Standard Deviation|Mean
2759014|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
2759015|NCT00813488|Secondary|Pain Intensity Difference (PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759016|NCT00813488|Secondary|Pain Intensity Difference (PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759017|NCT00813488|Secondary|Pain Intensity Difference (PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759018|NCT00813488|Secondary|Pain Intensity Difference (PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 10 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759019|NCT00813488|Secondary|Pain Intensity Difference (PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2759045|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2759020|NCT00813488|Primary|Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on scale|Participants|Standard Error|Least Squares Mean
2759021|NCT00813319|Primary|Total Doses Received of HPV Vaccine|As an additional primary outcome, we assessed the total number of vaccine doses received|measured at 7-months post randomization||||Doses|||Number
2759022|NCT00813319|Secondary|STD Incidence|Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction|7 months post randomization||||participants|||Number
2759023|NCT00813319|Primary|GARDASIL Vaccination Uptake and Compliance With Second and Third Doses|Number of participants who received at least 1 dose, 2 doses, 3 doses|measured at 7 months post-randomization||||participants|||Number
2759024|NCT00813176|Secondary|Mean Intraoperative Oxygenation During One-lung Ventilation|For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.|This measure occured during surgery.||||kPa||Standard Deviation|Mean
2759025|NCT00813176|Secondary|Number of Participants With Successful Reinflation|In each group, the number of Participants in which successful lung reinflation occurred.|This occurred during surgery.||||Participants|||Count of Participants
2759026|NCT00813176|Secondary|Time Required to Collapse the Lung|For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.|This measurement occurred during surgery.||||Minutes||Standard Deviation|Mean
2759027|NCT00813176|Secondary|Effectiveness of Lung Collapse|For each group, the number of participants in which lung collapse was evaluated as: (i) good—complete collapse without surgical interference, (ii) fair—total collapse, but with residual air, and (iii) poor—no or partial collapse, lung inflated and interfering with the surgical exposure.|This measure occured during surgery just after intubation.||||Participants|||Count of Participants
2759028|NCT00813176|Primary|Number of Participants in Which the Tube Was Successfully Positioned at First Attempt|Number of participants in each group in which the tube was successfully positioned at first attempt|This data measure was occurred during surgery.||||Participants|||Count of Participants
2759029|NCT00813176|Primary|Time Taken for Endotracheal Tube Placement Procedure.|"For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube.~Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope."|This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.||||minutes||Standard Deviation|Mean
2759030|NCT00813150|Secondary|Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria|Percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) is reported in the below table. IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescencec; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.|Up to 46 days after last bortezomib dose, or as soon as possible after early discontinuation of study treatment or before start of alternative anti-myeloma therapy|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.|||Percentage of participants|||Number
2759031|NCT00813150|Secondary|Overall Survival (OS)|Time interval in months time from randomisation to death from any cause.|From the date of randomization until Month 49|Intent-to-treat (ITT): Participants received at least 1 dose of study medication were included in the ITT analysis set. Participants still alive at the end of the study or dropped out will be censored with the last available date.|||Months||95% Confidence Interval|Median
2759032|NCT00813150|Secondary|Progression-Free Survival (PFS)|PFS is defined as time from randomization to myeloma progression according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of ≥25 percent from lowest response level in Serum M-component and/or (the absolute increase must be ≥0.5 g/dL) Urine M-component and/or (the absolute increase must be ≥200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be ≥10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65mmol/L) that can be attributed solely to the plasma cell proliferative disorder. PFS included disease progression as well as death.|From the date of randomization until the disease progression or participant's death from any cause whichever occured first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): all participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication. Participants without progression and who are still alive at the end of the study or dropped out will be censored with the last available date.|||Months||95% Confidence Interval|Median
2759033|NCT00813150|Primary|Time to Progression of Disease|'Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|From the date of randomization until the disease progression or participant's death from any cause whichever occurred first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.|||Months||95% Confidence Interval|Median
2759034|NCT00813111|Secondary|Number of Participants With Adverse Events||30 days|||||||
2759035|NCT00813111|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|"Assessments of postoperative pain included pain intensity at rest (using the NRS at rest [NRS-R] and with activity [using the NRS-A]) where the prescribed activity was raising both arms.~Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain."|through 72 hours|Note: 136 subjects were randomized and received study drug and were included in the analyses. 10 subjects were randomized but not dosed and 4 additional subjects failed screening, resulting in 122 subjects.|||Units on a scale*hours||Standard Deviation|Mean
2759036|NCT00813098|Secondary|Change From Baseline at Week 4 on the Global Improvement Score.|"The IBS Global Improvement Scale (IBS-GAI) asks Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved? The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score."|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2759037|NCT00813098|Secondary|Change From Baseline at Week 4 on the Severity of Bloating|"Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being not at all and 100 mm being worst possible). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating."|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2759038|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Frequency|Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Number of daily stools||Standard Deviation|Mean
2759039|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Consistency Scores|Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2759040|NCT00813098|Secondary|Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate|"To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,Have you felt or experienced a sense of urgency to pass stool today? The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline."|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2759041|NCT00813098|Primary|Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4|"The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"|Week 4|Per protocol population; Last observation carried forward.|||Participants|||Number
2759042|NCT00812981|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2759043|NCT00812981|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 51|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2759044|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2759048|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.|||Participants|||Count of Participants
2759049|NCT00812981|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.|||Participants|||Count of Participants
2759050|NCT00812981|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2759051|NCT00812981|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2759052|NCT00812981|Secondary|Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
2759053|NCT00812981|Secondary|Number of Seroprotected Subjects for H5N1 HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2759054|NCT00812981|Secondary|Seroconversion Factor (SCF) for H5N1 HI Antibodies|The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Fold change||95% Confidence Interval|Geometric Mean
2759055|NCT00812981|Secondary|Number of Seroconverted Subjects Against Two Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2759056|NCT00812981|Secondary|Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2759057|NCT00812981|Secondary|Titers for Serum H5N1 HI Antibodies|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 0 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
2759058|NCT00812981|Primary|Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
2759059|NCT00812968|Secondary|Percentage of Bone Marrow Promyelocytes|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."|||Percentage of promyelocytes||Full Range|Median
2759060|NCT00812968|Secondary|Percentage of Bone Marrow Myeloblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."|||Percentage of myeloblasts||Full Range|Median
2759335|NCT00811317|Secondary|Nadir Blood Glucose Level for Each Hypoglycemic Event||24 hours||||mg/dl|||Number
2759062|NCT00812968|Secondary|Number of Participants With a Cytogenetic Response|"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.~A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period."|Response was assessed every 12 weeks through Week 156|Efficacy population|||participants|||Number
2759063|NCT00812968|Secondary|Number of Participants With a Platelet Response|"Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 30,000/mm^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.~Minor response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 50% increase in platelet count with an absolute increase > 10,000/mm^3 and < 30,000/mm^3 sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with a Baseline platelet count of < 100,000/mm^3 or who were platelet-transfusion dependent at Baseline. There were no patients with platelet count of < 100,000/mm3 or who were platelet-transfusion dependent at Baseline, and thus platelet response was not evaluated.||||||
2759064|NCT00812968|Secondary|Number of Participants With a Neutrophil Response|"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.~A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with Baseline neutrophil count < 1,500/mm^3.|||participants|||Number
2759065|NCT00812968|Secondary|Change From Baseline in Hemoglobin Concentration|Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.|Baseline and from Day1 until the maximum observed value (up to 155 weeks)|Efficacy population with a erythroid response|||g/dL||Full Range|Median
2759066|NCT00812968|Secondary|Duration of Erythroid Response|Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.|From the first dose of study drug through Week 156|Efficacy population with a erythroid response|||weeks||95% Confidence Interval|Median
2759067|NCT00812968|Secondary|Time to Erythroid Response|Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.|From the first dose of study drug through Week 156|Efficacy population|||weeks||Full Range|Median
2759068|NCT00812968|Secondary|Number of Participants With a Erythroid Response|"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.~A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.~Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days."|Response was assessed every 28 days through Week 156.|Efficacy population: all patients who had a diagnosis of low- or intermediate-1-risk MDS associated with anemia based on confirmation by the central reviewers and received at least 1 dose of study drug.|||participants|||Number
2759069|NCT00812968|Secondary|Apparent Terminal Elimination Rate Constant of Lenalidomide|Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||1/h||Geometric Coefficient of Variation|Geometric Mean
2759070|NCT00812968|Secondary|Apparent Total Plasma Clearance (CL/F) of Lenalidomide|Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||mL/minute||Geometric Coefficient of Variation|Geometric Mean
2759071|NCT00812968|Secondary|Apparent Volume of Distribution (VzF) of Lenalidomide|Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||liters||Geometric Coefficient of Variation|Geometric Mean
2759072|NCT00812968|Secondary|Terminal Half-life (T1/2) of Lenalidomide|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||hours||Geometric Coefficient of Variation|Geometric Mean
2759073|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.|Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759074|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide|Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759075|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide|Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759076|NCT00812968|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenalidomide|Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population|||hours||Full Range|Median
2759077|NCT00812968|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lenalidomide|Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|Pharmacokinetic (PK) population: all patients who adhered to the study treatment during the course of PK assessment (Days 1 to 5 of Cycle 1) and from whom blood and urine samples were collected.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759078|NCT00812968|Primary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).|Safety population: all patients who received at least 1 dose of study drug.|||participants|||Number
2759079|NCT00812955|Other Pre-specified|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2759080|NCT00812955|Other Pre-specified|Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Inter-Quartile Range|Median
2759081|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2759082|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2759083|NCT00812955|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|"The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups:~ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set."|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2759084|NCT00812929|Secondary|Derived Pharmacokinetic (PK) Parameters for GSK2190915|PK samples were supposed to be collected at 10 minutes prior to the exercise challenge at 2 hours, 9.5 hours and 24 hours.|Pre dose, 2 hours, 3.5 hours, 9.5 hours, 11 hours and 24 hours following exercise challenge of each treatment period|PK Population was defined as participants in the ‘All Subjects’ Population for whom a PK sample was obtained and analyzed. Data was not collected for this outcome measure.||||||
2759085|NCT00812929|Secondary|Percentage Change From Baseline in Urine Leukotriene E4 (LTE4)|Analysis of LTE4 levels in the urine samples indicated the extent of LTE4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (pre dose) up to 24 Hours post dose of each treatment period|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Full Range|Median
2759086|NCT00812929|Secondary|Percentage Change From Baseline in Blood Leukotriene B4 (LTB4)|Analysis LTB4 levels in the blood samples indicated the extent of LTB4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (pre dose) up to 24 Hours post dose of each treatment period|Pharmacodynamics (PD) Population was defined as participants in the ‘All Subjects’ Population for whom a PD sample (blood or urine) was obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||Percent change||Full Range|Median
2759087|NCT00812929|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and medically significant.|Up to follow up (7 to 21 days) following last dose|All Subjects Population.|||Participants|||Count of Participants
2759088|NCT00812929|Secondary|Assessment of Hematology Parameters: Red Blood Cell Count (RBC)|Blood samples were collected for the assessment of hematology parameter for RBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Cells x 10^12 per liter||Standard Deviation|Mean
2759089|NCT00812929|Secondary|Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV)|Blood samples were collected for the assessment of hematology parameter for MCV at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Femtoliter||Standard Deviation|Mean
2759090|NCT00812929|Secondary|Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH)|Blood samples were collected for the assessment of hematology parameter for MCH at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed|||Picograms||Standard Deviation|Mean
2759091|NCT00812929|Secondary|Assessment of Hematology Parameters: Hematocrit|Blood samples were collected for the assessment of hematology parameters for hematocrit at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
2759092|NCT00812929|Secondary|Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples were collected for the assessment of hematology parameters for hemoglobin and MCHC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||G/L||Standard Deviation|Mean
2759093|NCT00812929|Secondary|Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC)|Blood samples were collected for the assessment of hematology parameters for basophils, eosinophils, lymphocytes, monocytes, TN, platelet count, WBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Cells x 10^9 per liter||Standard Deviation|Mean
2759094|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN)|Blood samples were collected for the assessment of clinical chemistry parameters for calcium, chloride, glucose, potassium, sodium and urea/BUN at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. Participants fasted for glucose blood sample. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Millimole per liter (mmol/L)||Standard Deviation|Mean
2759095|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine|Blood samples were collected for the assessment of clinical chemistry parameters for direct bilirubin, total bilirubin and creatinine at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants available at the indicated time points were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2759336|NCT00811317|Secondary|Number of Hypoglycemic Events|This outcome captures the number of hypoglycemic events that occurred throughout the entire study|24 hours||||Number of events|||Number
2759096|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT)|Blood samples were collected for the assessment of clinical chemistry parameters for ALP, ALT, AST and GGT at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants available at the indicated time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2759097|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Albumin, Total Protein|Blood samples were collected for the assessment of clinical chemistry parameters for albumin and total protein at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Gram/liter (G/L)||Standard Deviation|Mean
2759098|NCT00812929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|All participants rested for at least 10 minutes in the supine position prior to ECG recordings. ECG Baseline values for each treatment period was calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours, 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours. Participants with not clinically significant (NCS) abnormal values were reported. Potential clinical importance range for the ECG parameters are as follows: absolute QTc interval >450 millisecond (msec), increase from Baseline QTc >60 msec, PR interval <110 and >220 msec and QRS interval <75 and >110 msec. No participants reported clinically significant abnormal values.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period|All Subjects Population.|||Participants|||Count of Participants
2759099|NCT00812929|Secondary|Assessment of Vital Signs: Heart Rate (HR)|All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for HR for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period|All Subjects Population.|||Beats per minute||Standard Deviation|Mean
2759100|NCT00812929|Secondary|Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for SBP and DBP for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period|All Subjects Population was defined as all participants who received at least one dose of study medication.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2759101|NCT00812929|Secondary|Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge|Rescue medication was provided to participants at any time and it was strongly recommended for participants with a FEV1 decrease of at least 40% following exercise challenge compared to Baseline. Rescue medication was administered 0 to 90 minutes post exercise challenge. Statistical analysis was supposed to be performed using logistic regression, however, the data was too sparse to permit any formal statistical analysis.|0 to 90 minutes following exercise challenge of each treatment period|Efficacy Population.|||Participants|||Count of Participants
2759102|NCT00812929|Secondary|Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge|"The time from maximal percentage change in FEV1 to recovery to within 5% of pre challenge Baseline (in minutes) was derived using actual sampling times. Time to FEV1 recovery= [SAS date/time of recovery(a) FEV1 - SAS date/time of FEV1 Maximum % Change0-60] / 60, where a is earliest recorded FEV1 either above pre-challenge Baseline or within 5% below pre challenge Baseline. Any unscheduled FEV1 measurements taken after last scheduled post challenge measurement was considered when deriving this endpoint. A corresponding censoring variable was derived for analysis to indicate whether recovery to within 5% of pre-challenge Baseline was achieved. The censoring variable was set to 1 if recovery to within 5% of Baseline was achieved. If recovery was not evident from data collected, time to recovery was calculated using the date/time of the last available post challenge FEV1 assessment and censoring variable was set to zero. Analysis was performed using a Cox proportional hazards model."|0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period|Efficacy Population.|||Minutes||95% Confidence Interval|Median
2759103|NCT00812929|Secondary|Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60)|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge.Weighted mean FEV1 percentage change recorded during 0-60 minutes post challenge was determined for each challenge, by dividing area under curve (AUC) for percent change from Baseline FEV1 measurements at 5, 10, 15, 30, 45 and 60 minutes post challenge by time interval. Actual times were used to determine time interval where available; otherwise planned relative time was used. If one or more FEV1 values were missing, AUC was calculated over time interval of available values. If intermittent values were missing over a participant's profile,it was assumed to be linear between 2 available values for calculation of AUC. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1.|Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period.|Efficacy Population.|||Percent change||Standard Error|Least Squares Mean
2759321|NCT00811317|Secondary|Set Point Using CGM Data as the Input to the Controller for Future Studies|The algorithm in the Bionic Pancreas must have a pre-specified target glucose it is trying to achieve in order to make dosing decisions. Using data from this study, investigators planned to determine what an appropriate glucose target should be for future studies.|24 hours||||mg/dl|||Number
2759104|NCT00812929|Secondary|Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at >=80% of the predicted value for 6 minutes), the FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period.|Efficacy Population.|||Percent change||Standard Error|Least Squares Mean
2759105|NCT00812929|Primary|Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum (i.e., most negative) percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at >=80% of the predicted value for 6 minutes), FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period.|The ‘Efficacy Population’ was defined as all participants who received at least one dose of study medication and are not major protocol violators.|||Percent change||Standard Error|Least Squares Mean
2759106|NCT00812916|Secondary|Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points|Does not include 2 outliers with >300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure.|Procedural|Safety population with non-outlier endpoint reported|||points||Standard Deviation|Mean
2759107|NCT00812916|Secondary|Total Fluoroscopy Time|Mean total fluoroscopy time|Procedural|Safety population with fluoroscopy time reported|||minutes||Standard Deviation|Mean
2759108|NCT00812916|Secondary|Total Radiofrequency (RF) Duration|Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.|Procedural|Safety population with RF data reported|||minutes||Standard Deviation|Mean
2759109|NCT00812916|Secondary|Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time|Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes|Procedural|Safety population with mapping time reported|||minutes||Standard Deviation|Mean
2759110|NCT00812916|Secondary|Total Ablation Time|Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported|Procedural|Safety population with ablation time reported|||minutes||Standard Deviation|Mean
2759111|NCT00812916|Primary|Acute Success|Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion|End of procedure|Patients with CFAE-guided RF catheter ablation|||percentage achieving success||95% Confidence Interval|Number
2759112|NCT00812877|Secondary|Pulp Vitality|No evidence of pulpal resorption or calcification or periradicular radiolucency|Up to two years||||participants|||Number
2759113|NCT00812877|Primary|Tooth Survival|No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.|Up to two years|12 subjects were excluded in the Mineral Trioxide Aggregate group due to lack of follow-up (4 subjects were non-responsive; unable to contact 6 subjects; 2 subjects changed dentists) and 6 subjects were in the Calcium Hydroxide group (2 subjects were non-responsive; unable to contact 3 subjects; 1 subject was incarcerated).|||participants|||Number
2759114|NCT00812838|Secondary|Changes in International Index of Erectile Function Scores (IIEF)|"Subject's average scores on IIEF at baseline/screening visit to end of treatment at week 16 are compared~The subscale measures self-reported erectile function. Maximum score is 30, Minimum is 0. A score of 0 is the absolute best outcome. A score of 30 is the absolute worst outcome. Erectile Function score is a summation of questions 1,2,3,4, and 15. This study is assessing their erectile function and not the other subscales.~The other subscale scores are :~Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0~Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0~Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0~Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0~Subscales are not combined to make a total composite score.~*Crossover subjects were added to Experimental Group for analysis*"|Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16|*Crossover subjects were added to Experimental Group for analysis*|||score on a scale||Standard Deviation|Mean
2759159|NCT00812461|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS|||units on a scale||Standard Error|Mean
2759115|NCT00812838|Secondary|Change in Penile Plaque Size|"Results of ultrasound at baseline/screening visit to end of treatment at week 16 will be compared.~*Crossover subjects were added to Experimental Group for analysis*~Change is calculated as week 16 values values minus screening visit values~Increase in value equates to increased plaque size Decrease in value equates to decreased plaque size"|Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16|*Crossover subjects were added to Experimental Group for analysis*|||cubic millimeters||Standard Deviation|Mean
2759116|NCT00812838|Secondary|Change in Penile Blood Flow for Diameter|"Results of penile doppler ultrasound from the baseline/screening visit to end of treatment at week 16 will be compared.~Diameter is assessed here.~Change is calculated as week 16 values - screening visit values~Negative values are a decrease in diameter Positive values are an increase in diameter"|Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16|*Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis.|||cm||Standard Deviation|Mean
2759117|NCT00812838|Secondary|Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)|"Results of penile doppler ultrasound from baseline/screening visit to end of treatment at week 16 will be compared.~peak systolic velocity (PSV) and end-diastolic velocity (EDV) are assessed here.~Change is calculated as week 16 values - screening visit values~Negative values are a decrease in velocity Positive values are an increase in velocity"|Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16|*Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis.|||cm/s||Standard Deviation|Mean
2759118|NCT00812838|Primary|Average Percent Change of Penile Curvature in Degrees|"Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16~*Crossover subjects were added to Experimental Group for analysis*~Negative value equates to a reduction in curvature Positive value equates to an increase in curvature"|Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16|*Crossover subjects were added to Experimental Group for analysis*|||percent change||Standard Deviation|Mean
2759119|NCT00812812|Secondary|Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal|Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).|Week 8 or Withdrawal (up to Week 8)|All participants who received paroxetine and in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2759120|NCT00812812|Secondary|Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8|CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.|||scores on a scale||Standard Deviation|Mean
2759121|NCT00812812|Secondary|Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8|CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders.|Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.|||participants|||Number
2759122|NCT00812812|Secondary|Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Weeks 1, 2, 3, 4, and 6|FAS. The analysis was performed on the observed case (OC) dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week.|||scores on a scale||Standard Error|Least Squares Mean
2759123|NCT00812812|Primary|Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset.|||scores on a scale||Standard Error|Least Squares Mean
2759124|NCT00812708|Secondary|Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure)|Another secondary safety measure of the study was the need to explant or exchange a Morcher iris diaphragm within 1 year of implantation. Explantation in < 25% of patients was considered to be clinically acceptable.|Preoperatively and 1 year postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
2759125|NCT00812708|Secondary|Change in Endothelial Cell Count (Secondary Safety Measure)|A secondary safety measure of the study was the change in endothelial cell count. A loss of >10% of central corneal endothelial cells was considered clinically significant at the onset of the study. (Note, the 10% loss criterion was established before the 67B implant was added to the list of study devices. The 67B implant has an expected greater cell loss than that associated with the 96F, 96S, 50D, and 50F modified capsule tension rings because it requires a larger incision for implantation. Thirty one (48.4%) of the 64 patients were implanted with the 67B device.)|Preoperatively and 3 months postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms, for whom simultaneous corneal transplantation was not performed, and in whom endothelial cell counts could be obtained preoperatively and postoperatively.|||Participants|||Count of Participants
2759126|NCT00812708|Secondary|Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure)|Another secondary efficacy measure of the study was night time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.|Preoperatively and 3 months postoperatively||||Participants|||Count of Participants
2759127|NCT00812708|Secondary|Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure)|A secondary efficacy measure of the study was day time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.|Preoperatively and 3 months postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
2759128|NCT00812708|Primary|Change in Best Corrected Visual Acuity (Primary Safety Measure)|The primary safety measure of the study was the change in best corrected distance visual acuity (CDVA) as measured using a Snellen eye chart. A ≥ 2 line improvement in Snellen CDVA following Morcher device implantation was considered a positive clinical change (visual acuity better). A ≥ 2 line worsening of Snellen CDVA following Morcher device implantation was considered a negative clinical change (visual acuity worse). A change of < 2 lines was considered to be a neutral change (visual acuity the same).|Preoperatively and 1 year postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
2759129|NCT00812708|Primary|Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)|The primary efficacy measure of the study was the change in corrected distance visual acuity (CDVA) under glare conditions. A transilluminator light was held just in front of the distance corrected study eye in one of four quadrants (above, below, nasal, or temporal) to the line of sight to evoke a glare response. The direction that produced the worst CDVA was called the CDVA with glare. A ≥ 2 line improvement in Snellen CDVA with glare following Morcher device implantation was considered a positive clinical change (glare sensitivity better). A ≥ 2 line worsening of Snellen CDVA with glare following Morcher device implantation was considered a negative clinical change (glare sensitivity worse). A change of < 2 Snellen lines following Morcher device implantation was considered to be a neutral change (glare sensitivity the same).|Preoperatively and 1 year postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
2759130|NCT00812604|Secondary|The Mandibular Function.|The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.|4 weeks||||mm||Standard Deviation|Mean
2759131|NCT00812604|Primary|The Efficacy in the Treatment of TMJ and Muscle Pain|"The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).~The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as no pain ( 0 mm) and  worst pain possible ( 100 mm)."|4 weeks||||units on a scale||Standard Deviation|Mean
2759132|NCT00812565|Secondary|Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24|Cerebral glucose metabolism was measured in validated 3 dimensional statistic surface projection analysis (Cortex ID®, GE Healthcare), transversal/coronal/sagittal-slice analysis (HERMES BRASS), and voxel-wise whole brain analysis (SPM5) using [18F]fluorodeoxyglucose positron emission tomography.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||µCi/mL||Standard Deviation|Mean
2759133|NCT00812565|Secondary|Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24|The volume of the whole brain and of the left and right hippocampus was measured using high-resolution structural coronal 3D heavily T1-weighted gradient-echo sequence magnetic resonance imaging. All evaluations were done centrally by Professor Frederik Barkhof at the Image Analysis Centre, VU Medical Center, Amsterdam, Netherlands. A negative change score indicates loss of brain volume.|Screening to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||cm^3||Standard Deviation|Mean
2759134|NCT00812565|Secondary|Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24|A semi-structured interview was conducted by a physician, neuropsychologist, psychometrician, or certified study coordinator with the patient and a caregiver. Based on the results of the interview, the patient was rated on 6 domains of cognition and function: Memory, orientation, judgment/problem solving, community activities, home and hobbies, and personal care. Each domain is rated from 0 = no dementia; 0.5 = questionable dementia, mild cognitive impairment; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. The total score ranges from 0 to 18 with a higher score indicating more dementia. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2759160|NCT00812461|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS|||percentage of participants|||Number
2759161|NCT00812461|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS|||g||Standard Error|Mean
2759135|NCT00812565|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24|The ADAS-ADL consists of 23 questions that measure the ability of a person to perform basic activities of daily living, such as eating, walking, bathing, grooming, and dressing. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 78 with a lower score indicating more impaired ability. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2759136|NCT00812565|Secondary|Change From Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24|The ADAS cog consists of 11 items that assess cognitive areas that are often impaired in Alzheimer's disease, specifically learning (word list), naming (objects), following commands (1 to 5 elements), ideational praxis (mail a letter), constructional praxis (copy 4 figures), orientation (person, time and place), recognition memory (from a second word list), and remembering test instructions (from the recognition subtest). The test includes 3 additional subjective scales that assess spoken language ability, word finding difficulty, and comprehension. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 70 with a higher score indicating greater cognitive impairment. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2759137|NCT00812565|Secondary|Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24|The MMSE test contains 30 questions that assess 8 cognitive domains (orientation to time, orientation to place, registration, attention and calculation, recall, language, repetition, and complex commands). The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 (severe impairment) to 30 (no impairment), with a higher score indicating a better mental status. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2759138|NCT00812565|Secondary|Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining tau and phosphorylated tau in cerebral spinal fluid were processed at a central laboratory using commercially available kits from Innogenetics NV (INNOTEST® hTau Ag, INNOTEST PHOSPHO-TAU (181P); Gent, Belgium). To measure phosphorylated tau, tau phosphorylated at threonine 181 (pTau181) was determined.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
2759139|NCT00812565|Secondary|Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||RTU||Standard Deviation|Mean
2759140|NCT00812565|Secondary|Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining Aβ1-40 and Aβ1-42 in cerebral spinal fluid were processed at a central laboratory using a commercially available kit from Meso Scale Discovery (MSD 96-Well Multi-Spot Human/Rodent (4G8) Abeta Triplex Ultra-Sensitive Assay; Rockville, MD, USA).|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
2759141|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||RTU*days||Standard Deviation|Mean
2759337|NCT00811317|Secondary|Percentage of Time Spent With BG < 70 mg/dl||24 hours||||percentage of time||Standard Deviation|Mean
2759338|NCT00811317|Secondary|Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target)||24 hours||||percentage of blood glucose measurements|||Number
2759142|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||(pg/mL)*days||Standard Deviation|Mean
2759143|NCT00812565|Secondary|Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||RTU||Standard Deviation|Mean
2759144|NCT00812565|Secondary|Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)|Samples for determining Aβ1-40 and Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
2759145|NCT00812565|Primary|Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||(pg/mL)*days||Standard Deviation|Mean
2759146|NCT00812487|Secondary|Mean Glucose|mean sensor glucose|24 hours||||mg/dl||Standard Deviation|Mean
2759147|NCT00812487|Secondary|Coefficient of Variation (CV)|CV is a measure of glycemic variability|24 hours||||percentage (mean glucose/SD)||Standard Deviation|Mean
2759148|NCT00812487|Primary|Hospital Readmission|All-cause hospital readmission within 30 days|30 days||||participants|||Number
2759149|NCT00812487|Primary|Hospital Length of Stay|Duration of hospitalization|participants were followed for the duration of hospital stay, median hospital stay 8 day||||days||Inter-Quartile Range|Median
2759150|NCT00812487|Secondary|Glycemic Lability Index (GLI)|GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements|24 hours||||(mg/dl)^2/hr*day-1||Inter-Quartile Range|Median
2759151|NCT00812487|Secondary|Quality of Life|Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).|30 days||||units on a scale||Inter-Quartile Range|Median
2759152|NCT00812487|Secondary|Brain Natriuretic Peptide (BNP)|Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits|72 hours||||pg/ml||Inter-Quartile Range|Median
2759153|NCT00812487|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).|72 hours||||mg/dl||Inter-Quartile Range|Median
2759154|NCT00812487|Secondary|Pre-ejection Period (PEP)|Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.|24 hours||||ms||Standard Deviation|Mean
2759155|NCT00812487|Secondary|High Frequency Heart Rate Variability|High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.|24 hours||||ms^2||Inter-Quartile Range|Median
2759156|NCT00812461|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759157|NCT00812461|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759158|NCT00812461|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS|||units on a scale||Standard Error|Mean
2759162|NCT00812461|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.|||days||Standard Error|Mean
2759163|NCT00812331|Secondary|Terminal Elimination Half-life (t1/2,Term) of TMC435|The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||hours||Full Range|Median
2759164|NCT00812331|Secondary|Elimination Rate Constant of TMC435|In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||1/hour||Full Range|Median
2759165|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435|The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng*h/mL||Full Range|Median
2759166|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435|The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - as all randomized participants who received at least 1 dose of study medication (TMC435).|||ng*h/mL||Full Range|Median
2759167|NCT00812331|Secondary|Fluctuation Index (FI) of TMC435|The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||% fluctuation||Full Range|Median
2759168|NCT00812331|Secondary|Average Steady-State Plasma Concentration (Css,av) of TMC435|The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
2759169|NCT00812331|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||hours||Full Range|Median
2759170|NCT00812331|Secondary|Maximum Plasma Concentration (Cmax) of TMC435|The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
2759171|NCT00812331|Secondary|Minimum Plasma Concentration (Cmin) of TMC435|The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
2759172|NCT00812331|Secondary|Predose Plasma Concentration (C0h) of TMC435|The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.|Predose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
2759173|NCT00812331|Secondary|Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period|The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.|During the 7-day of TMC435 treatment period|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||Participants|||Number
2759174|NCT00812331|Secondary|Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period|The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population - all randomized subjects who received at least 1 dose of study medication (TMC435)|||Participants|||Number
2759339|NCT00811317|Secondary|Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals||After each of 3 meals||||percentage of time||Standard Deviation|Mean
2759175|NCT00812331|Secondary|Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period|The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population- all randomized subjects who received at least 1 dose of study medication (TMC435)|||Participants|||Number
2759176|NCT00812331|Primary|Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels|The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.|Baseline, Day 3, and Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||log10 IU/mL||Standard Error|Mean
2759177|NCT00812253|Secondary|Cardiac Output|Cardiac output measured using impedance cardiography at 72 hours.|72 hours|Patients without data due to medical devices, conditions that preclude measurement of PEP such as arrhythmias, or technical problems.|||liter/min||Standard Deviation|Mean
2759178|NCT00812253|Secondary|Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) was measured at day 3|72 hours||||pg/ml||Inter-Quartile Range|Median
2759179|NCT00812253|Secondary|Change in Quality of Life|Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL),|30 day||||units on a scale||Standard Deviation|Mean
2759180|NCT00812253|Secondary|Heart Rate Variability|High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone).|72 hours|Subjects with medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems could not be analyzed.|||ms^2||Inter-Quartile Range|Median
2759181|NCT00812253|Secondary|Hospital Readmission|All-cause hospital readmission at 30 days after discharge|30 days||||participants|||Number
2759182|NCT00812253|Primary|Hospital Length of Stay|Duration of hospitalization in days|Days||||days||Inter-Quartile Range|Median
2759183|NCT00812110|Primary|Number of Participants Who Received Influenza Vaccine.|Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination|1 hour||||participants|||Number
2759184|NCT00812110|Secondary|Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?|Number of participants who received influenza vaccine the prior year.|16 months||||participants|||Number
2759185|NCT00812097|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects are included.|||inches||Standard Deviation|Mean
2759186|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2759187|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2759188|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2759189|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2759190|NCT00812006|Secondary|Treatment Satisfaction (TS)|Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.|24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and post-dose satisfaction measurement at the 24-hour time point.|||Attacks|||Number
2759191|NCT00812006|Secondary|Normal Rating of Functional Disability (NRFD)|Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.|||Attacks|||Number
2759192|NCT00812006|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.|||Attacks|||Number
2759193|NCT00812006|Secondary|Sustained Pain Relief (SPR)|24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.|2 - 24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the attack must have met the FAS criteria for PR at 2 hours post-dose, and from 2-24 hours the participant either answered 24-hour headache recurrence question or didn't have PR at any time or took rescue.|||Attacks|||Number
2759194|NCT00812006|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.|||Attacks|||Number
2759195|NCT00811954|Secondary|Self-reported Adherence|Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.|At Weeks 4, 24, 48, 96, and 144|Intention to treat: All participants with fasting self-reported adherence data were included.|||percentage of prescribed medication||95% Confidence Interval|Mean
2759196|NCT00811954|Secondary|Change in Waist:Height Ratio From Baseline|Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.|||cm:cm||95% Confidence Interval|Mean
2759197|NCT00811954|Secondary|Change in Waist Circumference From Baseline|Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.|||cm||95% Confidence Interval|Mean
2759198|NCT00811954|Secondary|Change in Framingham 10-year Risk of MI or Coronary Death From Baseline|"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk."|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||percent risk||95% Confidence Interval|Mean
2759199|NCT00811954|Secondary|Change in Fasting Plasma Glucose Level From Baseline|Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
2759200|NCT00811954|Secondary|Change in Fasting Triglycerides Level From Baseline|Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
2759201|NCT00811954|Secondary|Change in Fasting HDL Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
2759202|NCT00811954|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
2759231|NCT00811928|Secondary|Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization|Death from any cause.|Randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
2759340|NCT00811317|Secondary|Peak Hyperglycemia Following Each Meal||After each of 3 meals||||mg/dl||Standard Deviation|Mean
2759203|NCT00811954|Secondary|Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)|The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||events per 100 person-years||95% Confidence Interval|Number
2759204|NCT00811954|Secondary|Incidence of Death or AIDS Defining Events (CDC Category C)|The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||events per 100 person-years||95% Confidence Interval|Number
2759205|NCT00811954|Secondary|CD4+ T-cell Count Changes From Baseline|Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count|Study entry to weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||cells/mm^3||95% Confidence Interval|Mean
2759206|NCT00811954|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm3)|At Weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||cells/mm^3||95% Confidence Interval|Mean
2759207|NCT00811954|Secondary|Presence of Mutations Associated With INI Resistance|The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure.|||participants|||Number
2759208|NCT00811954|Secondary|Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance|The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure|||participants|||Number
2759209|NCT00811954|Secondary|Presence of Mutations Associated With NRTI Resistance|The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure|||participants|||Number
2759210|NCT00811954|Secondary|Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96|"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
2759211|NCT00811954|Secondary|Cumulative Incidence of First Adverse Event by Week 96|"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up."|From study entry to week 96|As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment.|||cumulative events per 100 persons||95% Confidence Interval|Number
2759212|NCT00811954|Primary|Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96|The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative events per 100 persons||95% Confidence Interval|Number
2759213|NCT00811954|Primary|Cumulative Probability of First Virologic Failure by Week 96|"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
2759214|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 52|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759215|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 52|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759216|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 52|FAS|||units on a scale||Standard Error|Mean
2759217|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 52|FAS|||units on a scale||Standard Error|Mean
2759218|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 13|FAS|||percentage of participants|||Number
2759219|NCT00811941|Secondary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 13|FAS|||g||Standard Error|Mean
2759220|NCT00811941|Secondary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.|Baseline and Month 13|FAS|||days||Standard Error|Mean
2759221|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759222|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759223|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS|||units on a scale||Standard Error|Mean
2759224|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS|||units on a scale||Standard Error|Mean
2759225|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS|||percentage of participants|||Number
2759226|NCT00811941|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS|||g||Standard Error|Mean
2759227|NCT00811941|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the APTS who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.|||days||Standard Error|Mean
2759228|NCT00811941|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|All-patients-treated Set (APTS)|||percentage of participants|||Number
2759229|NCT00811941|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.|All-patients-treated set (APTS) – all patients in the APRS excluding those with no recorded investigational medicinal product (IMP) intake and all IMP returned|||participants|||Number
2759230|NCT00811928|Secondary|Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization|"Exact Causes of Death and Their Relationship to IFI Episode Were As Follows:~Unlikely related: participant completed treatment and cause of death was due to primary disease or complication~Possibly related: IFI undergoing treatment without stabilization, or with failure to have a complete remission, where cause of death might have been due to IFI, including progression or relapse of primary disease~Probably related: autopsy or clinical signs suggested that progression of IFI was the probable cause of death"|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
2759341|NCT00811317|Secondary|Percentage of Time Spent Within 70-180 mg/dl||24 hours||||percentage of time||Standard Deviation|Mean
2759232|NCT00811928|Secondary|Number of Participants With Clinical Failure During Treatment|"Clinical failure was defined as follows:~Presence of a proven or probable IFI~Systemic antifungal treatment (IV) for 4 consecutive days or more than 10 days total~Discontinuation due to adverse event (AE) possibly or probably related to study drug~Lost-to-follow-up or discontinuation from the study for any reason with loss to follow-up during the Treatment Phase"|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
2759233|NCT00811928|Secondary|Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy|The time measured in days from randomization to the administration of the first concomitant systemic anti-fungal therapy in the entire FAS population. Not all participants who accepted systemic anti-fungal therapy may have had a IFI clinical diagnosis. IFI diagnosis criteria for antifungal therapy administration may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||Days|||Number
2759234|NCT00811928|Secondary|Time From Randomization to the First Onset of Proven or Probable IFI|The time measured in days to the first occurrence of proven/probable IFI diagnosis in the entire FAS population from randomization to Day 100 of follow-up visit. Participants may not have accepted immediate antifungal treatment and later received antifungal treatment based upon further investigator review of the participant's IFI condition. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, positive blood/biopsy cultures with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||Days|||Number
2759235|NCT00811928|Secondary|Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization|Number of participants who developed a proven or probable IFI from randomization date to Day 100 of follow-up visit. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
2759236|NCT00811928|Primary|Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period|Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks [84 days]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 Weeks (84 days) plus 7 days|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
2759237|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759238|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759239|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759240|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759241|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759242|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759243|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759244|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
2759245|NCT00811798|Primary|Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Day 0 up to the telephone contact at Month 12).||||Subjects|||Number
2759246|NCT00811733|Secondary|Number of Participants With the Indicated Infusion-related >=Grade 3 AE|Infusion-related AEs are the AEs that resulted from administration of study drug through infusion. AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced >=Grade 3 infusion-related AEs were assessed.|||participants|||Number
2759247|NCT00811733|Secondary|Number of Participants With the Indicated >=Grade 3 AEs|AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a >=Grade 3 AE were assessed.|||participants|||Number
2759248|NCT00811733|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study|Certain AEs led to permanent discontinuation of study drug and hence resulted in their withdrawal from the study.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an AE leading to their withdrawal from the study were assessed.|||participants|||Number
2759249|NCT00811733|Secondary|Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a study drug-related AE were assessed.|||participants|||Number
2759250|NCT00811733|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an SAE categorized as being related to study drug were assessed.|||participants|||Number
2759251|NCT00811733|Secondary|Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment|CD4+ and CD19+ are two key flow cytometry parameters, and total hemolytic complement (CD50) is a complement parameter. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Month 3|ITT Population: only participants with blood count data at both Baseline and Month 3 were included in the analysis.|||cells per microliter (µL)||Full Range|Median
2759252|NCT00811733|Secondary|Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result|All human-antihuman antibody (HAHA) samples were first tested in a screening assay to identify potential HAHA positives. Next, samples that tested positive in the screening assay were further tested in the confirmation assay to determine the specificity of the signal to ofatumumab. Confirmed positive samples were reported as positive.|From baseline up to approximately 5 years|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.|||participants|||Number
2759322|NCT00811317|Secondary|Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard|Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (< 70 mg/dl) and hyperglycemia (>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian|24 hours||||percent absolute difference||Standard Deviation|Mean
2759342|NCT00811317|Primary|Average Blood Glucose Over the Closed-loop Control Period||24 hours||||mg/dl||Standard Deviation|Mean
2759253|NCT00811733|Secondary|AUC(0-tau) and AUC(0-inf) of Ofatumumab|AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..|||micrograms X hours/milliliters (µg.h/mL)||95% Confidence Interval|Geometric Mean
2759254|NCT00811733|Secondary|Cmax and Ctrough of Ofatumumab|Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be determined.|||micrograms/milliliter (µg/ml)||95% Confidence Interval|Geometric Mean
2759255|NCT00811733|Secondary|Half-life of Ofatumumab|Half-life (t½) is defined as the time required for the concentration of the drug in plasma to decrease to one-half of its current value. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.|||Days (d)||95% Confidence Interval|Geometric Mean
2759256|NCT00811733|Secondary|Volume of Distribution at Steady State of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of the drug in the body at steady state. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.|||Liters (L)||95% Confidence Interval|Geometric Mean
2759257|NCT00811733|Secondary|Clearance of Ofatumumab|Clearance (CL) is defined as the volume of plasma that is cleared of drug per unit of time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|Pharmacokinetic (PK) Population: all participants from whom a PK sample was obtained and analyzed. Data were provided for the number of participants for whom the parameter could be determined.|||milliliters/hour (ml/hr)||95% Confidence Interval|Geometric Mean
2759258|NCT00811733|Secondary|Overall Survival|Overall survival is defined as the time from baseline until death due to any cause.|From baseline up to approximately 5 years|ITT Population. Only those participants who died during the study and during the follow-up period were assessed.||||||
2759259|NCT00811733|Secondary|Time to Response for Responders|Time to response is defined as the time from baseline to the first response date.|From baseline up to approximately 5 years|ITT Population. Only participants classified as responders (CR, PR, and MR) were assessed.|||days||95% Confidence Interval|Median
2759260|NCT00811733|Secondary|Progression-free Survival|Time to disease progression is defined as the time from baseline to disease progression or death.|From baseline up to approximately 5 years|ITT Population. Participants who experienced disease progression or death were counted as events, and other participants were censored at the time of the last adequate assessment in the study.|||days|events|Inter-Quartile Range|Median
2759261|NCT00811733|Secondary|Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator|Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node >=1.5 centimeters on any axis. Progression for PR/MR is either a >=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.|From baseline up to approximately 5 years|ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study.|||days|events|Inter-Quartile Range|Median
2759262|NCT00811733|Secondary|Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)|IgM is a basic antibody that is produced by B cells. It is the first antibody to appear in response to initial exposure to antigen. IgM flare is defined as an IgM level that increases by >25% from baseline (BL) and is associated with a response to treatment. Avoidance of IgM flare indicates the lack of an increase in IgM of >25% from BL.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population. Only those participants who received Cycle 1 treatment (including the Redosing Cycle) were assessed.|||participants|||Number
2759263|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population|||participants|||Number
2759323|NCT00811317|Secondary|Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects||24 hours|This outcome was not analyzed. There were no open loop experiments in diabetic subjects that we were able to make a comparison with||||||
2759264|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population|||participants|||Number
2759265|NCT00811733|Primary|Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population|||participants|||Number
2759266|NCT00811733|Primary|Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|Intent-to-Treat (ITT) Population: all participants who were considered eligible for treatment and who had been exposed to study drug irrespective of the planned course of treatment.|||participants|||Number
2759267|NCT00811720|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759268|NCT00811720|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2759269|NCT00811720|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS|||units on a scale||Standard Error|Mean
2759270|NCT00811720|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS|||units on a scale||Standard Error|Mean
2759271|NCT00811720|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS|||percentage of participants|||Number
2759272|NCT00811720|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS|||g||Standard Error|Mean
2759273|NCT00811720|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.|||days||Standard Error|Mean
2759274|NCT00811655|Secondary|Overall Survival (OS)|Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|24 months after SRS|Intent-to-treat|||Months||95% Confidence Interval|Median
2759275|NCT00811655|Secondary|Number of Patients Who Died Due to Neurological Causes|Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.|Within 24 months post-SRS|Intent-to-treat|||participants|||Number
2759276|NCT00811655|Secondary|Clinical Significance of Locally Recurrent Brain Metastases|Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.|24 months post-SRS|There are no patients for this analysis because none had a local recurrence.||||||
2759277|NCT00811655|Secondary|Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.||||||
2759324|NCT00811317|Secondary|Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects||24 hours|This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with||||||
2759325|NCT00811317|Secondary|Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard|Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator|24 hours||||percent absolute difference||Standard Deviation|Mean
2759278|NCT00811655|Secondary|Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.||||||
2759279|NCT00811655|Secondary|Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site|Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.|||participants|||Number
2759280|NCT00811655|Secondary|Volume of Adjacent Normal Brain Parenchyma Irradiated|Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).|At time of SRS|Data for this outcome was not collected.||||||
2759281|NCT00811655|Secondary|Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery|Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.|||participants|||Number
2759282|NCT00811655|Primary|Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)|Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).|Within 12 months after SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.|||Participants|||Number
2759283|NCT00811642|Primary|Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 12|Pool of participants were from the Full Analysis Set (FAS): included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Participants|||Number
2759284|NCT00811642|Secondary|Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up|Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.|Follow-up week 14|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Participants|||Number
2759285|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 12|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.|||Participants|||Number
2759286|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 8|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.|||Participants|||Number
2759287|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 4|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. Last Observation Carried Forward (LOCF) was used for missing data.|||Participants|||Number
2759326|NCT00811317|Secondary|Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals||24 hours||||participants|||Number
2759327|NCT00811317|Secondary|Number of Participants Achieving a Stable Glucose Response to Insulin Dosing||24 hours||||participants|||Number
2759328|NCT00811317|Secondary|Number of Carbohydrate Interventions||24 hours||||number of interventions|||Number
2759288|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 8|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Participants|||Number
2759289|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 4|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Particpants|||Number
2759290|NCT00811590|Primary|The Size of Intestinal Polyps||24 months|Due to small enrollment number, analysis was not possible.||||||
2759291|NCT00811577|Secondary|Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Cells per high-powered field||Standard Deviation|Mean
2759292|NCT00811577|Secondary|Histological Evaluation of Collagen|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Percent||Standard Deviation|Mean
2759293|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Millimeters cubed||Standard Deviation|Mean
2759294|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Millimeters||Standard Deviation|Mean
2759308|NCT00811395|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN;"|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2759295|NCT00811577|Secondary|Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography|Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100 and placebo and 10 mg AZX100 for each of the two raters separately. Data from both raters was not combined.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the VAS outcome, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Millimeters||Standard Deviation|Mean
2759296|NCT00811577|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 months|The efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including the patients receiving placebo-only). In the ITT sample for the POSAS outcomes, available sample sizes were 122 at Day 42 and 113 at Month 12 (including 4 subjects who withdrew from the study but were still followed for safety until Month 12).|||Units on a scale||Standard Deviation|Mean
2759297|NCT00811564|Primary|Intraocular Pressure (IOP) at Week 12|Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-treat, which included all patients who started the study (randomized).|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
2759298|NCT00811473|Secondary|The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness|"The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of Much or Very much improved in overall bipolar illness assessment."|Day 57||||Proportions|||Number
2759299|NCT00811473|Secondary|CGI-BP-C Score at Final Assessment (Day 57)|The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from Baseline to day 57||||Scores on a scale||Standard Error|Least Squares Mean
2759300|NCT00811473|Secondary|Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S|The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from Baseline to Day 57||||Scores on a Scale||Standard Error|Least Squares Mean
2759301|NCT00811473|Secondary|The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score|The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57||||participants|||Number
2759302|NCT00811473|Secondary|Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).|The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57||||participants|||Number
2759303|NCT00811473|Primary|Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)|Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).|Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57||||Scores on a scale||Standard Error|Least Squares Mean
2759304|NCT00811434|Secondary|Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function|MHE as measured by failure of one or more cognitive test|before and after each treatment period|data not collected as planned||||||
2759305|NCT00811434|Secondary|Health Related Quality of Life (HRQOL)|HRQOL administered to parents prior to treatment|baseline|data not collected as planned||||||
2759306|NCT00811434|Primary|Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis|failure of one cognitive function test indicates presence of MHE|baseline||||participant|||Number
2759307|NCT00811395|Secondary|Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters per scan|||Number
2759319|NCT00811382|Primary|Days Lost|Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.|12 months||||Days lost per patient||Standard Deviation|Mean
2759320|NCT00811317|Secondary|Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject||24 hours|This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with||||||
2759309|NCT00811395|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as offset variable and:~Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates~Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||lesions per scan||95% Confidence Interval|Number
2759310|NCT00811395|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:~Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;~Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors."|baseline (before randomization in PDY6045 or PDY6046) and 48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters (mL)||Standard Error|Least Squares Mean
2759311|NCT00811395|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||percent probability||95% Confidence Interval|Number
2759312|NCT00811395|Secondary|Overview of 12-week Sustained Disability Progression|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.~If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2759313|NCT00811395|Primary|Overview of AE With Potential Risk of Occurence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly hair loss and hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2759314|NCT00811395|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as offset variable and:~Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates~Model 2 (GA groups): treatment group and region of enrollment as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||relapses per year||95% Confidence Interval|Number
2759315|NCT00811395|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2759316|NCT00811382|Secondary|Progression of AF and AT/AF Burden|The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment||||||
2759317|NCT00811382|Secondary|Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)|Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment||||||
2759318|NCT00811382|Secondary|Heart Failure Clinical Composite Score (Packer Score)|Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment||||||
2759343|NCT00811252|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.|Up to 8 weeks|C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS)|||participants|||Number
2759344|NCT00811252|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF|||percentage of patients|||Number
2759345|NCT00811252|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)||Week 8|FAS; LOCF|||percentage of patients|||Number
2759346|NCT00811252|Secondary|Change From Baseline in GDS Total Score After 8 Weeks of Treatment|The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.|Baseline and Week 8|FAS; observed cases (OC); ANCOVA|||units on a scale||Standard Error|Mean
2759347|NCT00811252|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759348|NCT00811252|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759349|NCT00811252|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759350|NCT00811252|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759351|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment||Baseline and Week 1|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759352|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment||Baseline and Week 2|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759353|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment||Baseline and Week 4|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2759354|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment||Baseline and Week 6|FAS; LOCF, ANCOVA|||units on a scale||Standard Error|Mean
2759355|NCT00811252|Primary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)|||units on a scale||Standard Error|Mean
2759356|NCT00811187|Primary|Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.|This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.|During Procedure|Intent to Treat Population (all participants assigned to lidocaine or saline).|||Score on a scale||Standard Deviation|Mean
2759357|NCT00811174|Secondary|Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)||12 months|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759358|NCT00811174|Secondary|Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents||before treatement 10 and 13 (of 13 or 17 treatments) and at the end|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759359|NCT00811174|Secondary|Pre-next-dose Levels of Serum Total IgG||before each treatment|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759360|NCT00811174|Secondary|Assessment of Viral Safety||Every three months|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759361|NCT00811174|Secondary|Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)||at each treatment date (every three to four weeks)|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759362|NCT00811174|Secondary|Vital Signs||during each treatment|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759363|NCT00811174|Primary|Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment|Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment|after 6 months of treatment|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
2759364|NCT00811174|Primary|Adverse Events|Occurrence of Adverse Events|During infusion or within 72 hours after end of infusion||||participants|||Number
2759365|NCT00811135|Secondary|Duration of Response (DR)|DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
2759366|NCT00811135|Secondary|Number of Participants With Response|Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
2759367|NCT00811135|Secondary|Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
2759368|NCT00811135|Secondary|Number of Participants With Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
2759369|NCT00811135|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
2759370|NCT00811135|Secondary|Number of Participants With Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
2759371|NCT00811135|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
2759372|NCT00811135|Secondary|Number of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
2759373|NCT00811135|Primary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
2759413|NCT00810901|Secondary|Talked to Parents About Choice to be Organ Donor on License at 12 Months|Number of teens who talk had not talked to parents at baseline but reported they had talked to their parents about the choice to become an organ donor on their driver's license at 12 months|12 months||||participants||95% Confidence Interval|Number
2759374|NCT00811070|Secondary|Overall Survival (OS) Rate - Part 2|OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death, censored at the participant's last contact date. Percent of participants with OS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759375|NCT00811070|Secondary|Progression-free Survival (PFS) Rate - Part 2|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to treatment discontinuation due to disease progression as assessed by the investigator. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percent of participants with PFS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759376|NCT00811070|Secondary|Time to Treatment Failure (TTF) Rate - Part 2|TTF was the interval from the date of first dose of bosutinib until the earlier date of progression or death (any cause), withdrawal from treatment owing to an AE, subject refusal, or loss to follow-up (censored at the last contact date), or further anti-tumor therapy before documented progression (whichever occurred first). TTF rate indicates the probability of no treatment failure. Percent of participants with no treatment failure were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759377|NCT00811070|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The duration of OHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort|||weeks||95% Confidence Interval|Median
2759378|NCT00811070|Secondary|Time to Achieve Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The time to OHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort|||weeks||95% Confidence Interval|Median
2759379|NCT00811070|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) Up to Week 192 in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|OHR included CHR, no evidence of leukemia (NEL), minor hematologic response (MiHR) or return to chronic phase (RCP), participants had to meet at least 1 of this criterion. Criteria for RCP: disappearance of features defining AP/BP, but still in CP and persistence of clonal evolution. Criteria for MiHR: <15% blasts in blood and bone marrow, <30% blasts+promyelocytes in blood and bone marrow, <20% basophils in blood, no extramedullary disease other than liver/spleen. Criteria for CHR and NEL: <20% basophils in blood, no extramedullary involvement including liver/spleen, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, <5% (NEL) and <=5% (CHR) marrow blasts, 0.5*10^9 <= Absolute neutrophil count (ANC) <1.0*10^9/L (NEL) and ANC>=1.0*10^9/L (CHR), 20*10^9 <=platelets<100 *10^9/L (NEL) and platelets>=100 but <450x10^9/L (CHR), white blood cells <=institutional upper limit of the normal range.|Baseline up to Week 192|Subset of the third-line cohort who was in accelerated or blast phase|||percentage of participants|||Number
2759380|NCT00811070|Secondary|Duration of Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population|||weeks||95% Confidence Interval|Median
2759381|NCT00811070|Secondary|Time to Achieve Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population.|||weeks||95% Confidence Interval|Median
2759382|NCT00811070|Secondary|Percentage of Participants With Complete Hematologic Response (CHR) up to Week 192 in Advance Phase Second-line Cohort - Part 2|CHR response was considered to be achieved if participants met all of the following criteria: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >=1.0*10^9 per liter (/L), platelets >=100 but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline up to Week 192|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759383|NCT00811070|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|Duration of MCyR was defined as the interval from the date of the earliest demonstration of a response, until the earliest date of loss of that response. Duration of response in weeks = (date of confirmed loss of first attained response minus date of first attained response)/7 days.|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population|||weeks||95% Confidence Interval|Median
2759396|NCT00811070|Primary|Maximum Tolerated Dose (MTD) - Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.|||mg|||Number
2759384|NCT00811070|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|"Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.~Time to response in weeks = (event date minus first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last cytogenetic assessment date of a participants."|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population|||weeks||95% Confidence Interval|Median
2759385|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Third-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759386|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759387|NCT00811070|Secondary|Percentage of Participants With Maintained Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line and Third-line Cohort - Part 2|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.~The responder for maintained MCyR included 'participants without baseline response who had a response at a specified time' and 'participants with baseline response who had a post-baseline response either maintained or improved at a specified time'."|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759388|NCT00811070|Primary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
2759389|NCT00811070|Secondary|Accumulation Ratio (R) - Part 1|R=accumulation ratio (AUCss on Day 15/AUC[0-24] on Day 1)|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Mean
2759390|NCT00811070|Secondary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.|||liter||Standard Deviation|Mean
2759391|NCT00811070|Secondary|Apparent Oral Clearance (CL/F) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F on Day 15 was assessed as the steady state CL/F.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||L/hr||Standard Deviation|Mean
2759392|NCT00811070|Secondary|Area Under the Concentration-Time Curve (AUC) - Part 1|Area under the plasma concentration time-curve from zero to infinity. AUC on Day 15 was assessed as the steady state AUC.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||nanogram*hour per milliliter (ng•hr/mL)||Standard Deviation|Mean
2759393|NCT00811070|Secondary|Plasma Decay Half-Life (t1/2) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.|||hour||Standard Deviation|Mean
2759394|NCT00811070|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||hour||Full Range|Median
2759395|NCT00811070|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2759397|NCT00811070|Primary|Number of Participants With Dose-Limiting Toxicity (DLT) - Part 1|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.|||Participants|||Number
2759398|NCT00811057|Secondary|The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery|Days gained after treatment to delivery|after delivery of the infant||||days||Standard Deviation|Mean
2759399|NCT00811057|Primary|The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.|Gestational age at delivery in weeks.|3-5 days after delivery||||weeks||Standard Deviation|Mean
2759400|NCT00811018|Primary|Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)|PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
2759401|NCT00811018|Primary|Percentage of Participants With Abnormal Prothrombin Time (PT)|PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
2759402|NCT00811018|Primary|Percentage of Participants With Vital Sign Results of Potential Clinical Importance|Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.|Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
2759403|NCT00811018|Primary|Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance|Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.|Weeks 28,60,72,84,96,104, Transition Visit up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
2759404|NCT00811018|Primary|Percentage of Participants With Elevated International Normalize Ratio (INR)|Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population|||percentage of participants|||Number
2759405|NCT00811018|Primary|Percentage of Participants With Anticoagulant Use|Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population|||percentage of participants|||Number
2759406|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)|Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab|||percentage of participants|||Number
2759407|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Chemistry)|Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab|||percentage of participants|||Number
2759408|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Hematology)|Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab|||percentage of participants|||Number
2759409|NCT00811018|Primary|Percentage of Participants With Total Bilirubin > 1.5 x ULN|Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population|||percentage of participants|||Number
2759410|NCT00811018|Primary|The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population|||percentage of participants|||Number
2759411|NCT00811018|Primary|The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population|||percentage of participants|||Number
2759412|NCT00811018|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Day 1 up to 82 months|Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study|||participants|||Number
2759415|NCT00810888|Secondary|Percent Change in Total Hemorrhage Volume (Intracerebral Hemorrhage (ICH) Plus Intraventricular Hemorrhage (IVH)).|Percent change in total volume (intracerebral hemorrhage (ICH) plus intraventricular hemorrhage (IVH)) from baseline CT to 24 hour CT. Percent change is expressed as difference between 24 hour total volume and baseline total volume divided by baseline total volume, expressed as a percentage. In order to examine the effect of rFIVIIa, the randomized groups, Group 1 and Group 2 only were statistically compared.|24 hours (+/- 3 hours) from baseline CT scan|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Percent change from baseline to 24 hours||Inter-Quartile Range|Median
2759416|NCT00810888|Secondary|Number of Participants With Agreement Between the Clinical Site Radiologists and the Study Radiologist With Respect to Identification of a Positive Spot Sign or the Absence of Positive Spot Sign on CTA|The CTA was originally interpreted by the site radiologist so that subjects could be identified as having a positive spot sign for eligibility for randomization. The positive spot sign is indicative that there is potential for further hemorrhagic growth and these subjects were thus eligible to be randomized to receive investigational drug or placebo. The CTA scans were subsequently assessed by the study radiologist and compared for agreement.|Baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Overall agreement was assessed but reported by group below."|||Participants|||Count of Participants
2759417|NCT00810888|Secondary|Number of Spot Positive Subjects With 90-day Outcome of Modified Rankin Scale Score >= 5|The modified Rankin Scale (0 is best, 5 is worst - non dead, 6 is dead) was used to define a bad outcome; categorized as a score >=5 versus <5. As the aim of the study was to examine the effect of rFIV!!a only the randomized groups, 1 and 2, defined as spot positive by CTA were compared.|90 days (+/- 7 days) from time of study enrollment|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
2759418|NCT00810888|Secondary|Number of Participants With Other Potentially Study Drug Related Thromboembolic Complications Such as Deep Venous Thrombosis (DVT) and Elevations in Troponin Not Associated With ECG Changes|Evidence of a deep venous thrombosis or an elevation of troponin within 4 days of completion of study drug administration that are not associated with ECG changes that could be related to the study drug|through day 4 after completion of study drug|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
2759419|NCT00810888|Primary|The Specificity of the Spot Sign for Predicting Hematoma Growth|"The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Specificity was estimated. Specificity or true negative rate is defined as, the number of non-spot positive (spot negative) strokes according to the gold standard / the total number of strokes identified as not spot positive."|Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group 2 and Group 3."|||Participants|||Count of Participants
2759420|NCT00810888|Primary|The Sensitivity of the Spot Sign for Predicting Hematoma Growth|"The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as Group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Sensitivity was estimated. Sensitivity or true positive rate is defined as, the number of strokes correctly identified as spot positive according to the gold standard / the total number of strokes identified as spot positive"|Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group 2 and Group 3."|||Participants|||Count of Participants
2759421|NCT00810888|Primary|Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours.|Comparison of only the subjects with a positive spot sign with respect to a categorical measure of hematoma growth from baseline to 24 hours. the outcome of interest is the percent of subjects with hematoma growth > 33% or > 6 cc increase in volume, from baseline to 24 hours.|From baseline to 24 hours|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
2759422|NCT00810888|Primary|Number of Study Subjects With Life-threatening Thromboembolic Complications|Thromboembolic complications are defined as development of (1) acute myocardial ischemia; or (2) acute cerebral ischemia; or (3) acute pulmonary embolism|through day 4 after completion of study drug administration|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
2759423|NCT00810810|Secondary|Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines|Blood samples were collected prior to surgery and at two times after surgery. White blood cells were isolated and frozen. The thawed cells were tested for the numbers and phenotype of regulatory cells and for the production of regulatory cytokines. Results obtained from samples collected after surgery were compared to the results obtained from the sample collected prior to surgery.|0 to 5 weeks after surgery|The study used stringent criteria for acceptance of these cellular assays. Invalid tests were not included in the analysis, therefor the numbers reported in the Outcome Measures table do not add up to the number analyzed for each test.|||Participants|||Count of Participants
2759424|NCT00810810|Primary|Number of Participants With Changes in the Production of Antibody to HLA Antigens|Blood samples were collected prior to surgery and at two times after surgery. Serum was tested for the presence of IgG antibody to HLA. the results of the samples collected after surgery were compared to those in the sample collected prior to surgery.|0 to 5 weeks after surgery|Antibody tests were invalid for some participants in Arm 1. Their sera contained interfering substances.|||Participants|||Count of Participants
2759425|NCT00810771|Secondary|If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.|"Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): did you discuss Colorectal Cancer Screening with your provider?"|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
2759426|NCT00810771|Secondary|Self Efficacy.|Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
2759427|NCT00810771|Secondary|Intent to Get Colorectal Cancer Screening.|Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
2759428|NCT00810771|Secondary|Decisional Satisfaction|"Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high.~Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction."|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||Percentage of participants|||Number
2759429|NCT00810771|Secondary|Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.|Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
2759430|NCT00810771|Secondary|Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider|Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).|3-5 days after Decider Guider intervention|Data was not collected for Usual Care arm.|||Degree of participation||Full Range|Mean
2759431|NCT00810771|Primary|Colorectal Cancer (CRC) Screening Rate.|The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.|Within 6 months of Decider Guider intervention.||||percentage of participants|||Number
2759432|NCT00810719|Secondary|Overall Survival|Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.|Up to 36 months||||months||95% Confidence Interval|Median
2759433|NCT00810719|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|Two patients withdrew consent in the first cycle and were not evaluable for response.|||percentage of participants|||Number
2759434|NCT00810719|Primary|Progression Free Survival|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 36 months||||months||95% Confidence Interval|Median
2759435|NCT00810693|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.|||Scores on a scale||Standard Deviation|Mean
2759507|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15||||ng*h/ml||Standard Deviation|Mean
2759436|NCT00810693|Secondary|EQ-5D Utility Score - Change From Baseline to Week 12|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.|||Scores on a scale||Standard Deviation|Mean
2759437|NCT00810693|Secondary|Borg CR 10 Scale - Change From Baseline to Week 12|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (Extremely strong - Maximal)."|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Scores on a scale||Standard Deviation|Mean
2759438|NCT00810693|Secondary|Percentage of Participants With Clinical Worsening|"The combined endpoint time to clinical worsening, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH ."|At week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Percentage of participants|||Number
2759439|NCT00810693|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 12|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.|||Percentage of participants|||Number
2759440|NCT00810693|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.|||pg/mL||Standard Deviation|Mean
2759441|NCT00810693|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.|||dyn*s*cm^-5||Standard Deviation|Mean
2759442|NCT00810693|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Meters||Standard Deviation|Mean
2759443|NCT00810641|Primary|Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial|The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.|one hour|Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses.|||participants||95% Confidence Interval|Number
2759444|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, Measuring Time to Consent From the Last Concussion in Subjects With Multiple Concussions.|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) with consent within one year from the last concussion in subjects who had multiple concussions.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up||||participants|||Number
2759452|NCT00810615|Primary|Computer Cognitive Test Scores - BrainCheckers Code Sub Recall|BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 135. The scores in this section represent results of the code sub recall subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759603|NCT00810043|Secondary|Change in Back Pain.|Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||units on a scale||Standard Deviation|Mean
2759445|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Multiple Non-concussive Blast and/or Impact Exposures.|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. Many subjects had multiple blast and/or impact events without a concussion (asymptomatic), but had a flight or flight (danger response) experience. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced multiple non-concussive blast and/or impact events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion who had multiple blast and/or impact event that did not result in a concussion (asymptomatic), but had a flight or flight (danger response) experience.|||participants|||Number
2759446|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Four or More Concussive Events|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced four or more concussive events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
2759447|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Three Concussive Events|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced three concussive events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
2759448|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Two Concussive Events|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced two concussive events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
2759449|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Only One Concussive Event|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in the individuals who experienced only one concussive event.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
2759450|NCT00810615|Secondary|Stem Cells: CD_34|A non-parametric regression 14 using the Theil estimator was fit to the observed data in order to demonstrate general trends for relations between measures of cognitive functioning and increased stem cells.|six weeks post hyperbaric exposure series|||||||
2759451|NCT00810615|Secondary|Functional MRI||six weeks post hyperbaric exposure series|||||||
2759522|NCT00810277|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal|Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum.|Up to Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
2759453|NCT00810615|Primary|Computer Cognitive Test Scores - BrainCheckers Matching To Sample|BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 50. The scores in this section represent results of the matching to sample subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759454|NCT00810615|Primary|Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 41 to 174. The scores in this section represent results of the Go-NoGo reaction time subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759455|NCT00810615|Primary|Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 25 to 118. The scores in this section represent results of the procedural reaction time.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759456|NCT00810615|Primary|Computer Cognitive Test Scores - BrainCheckers Code Substitution|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 9 to 66. The scores in this section represent results of the code substitution subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759457|NCT00810615|Primary|Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The simple reaction time range is 30 to 255.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759458|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Reaction Time|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The reaction time score demonstrates improvement as the score decreases. The score range was 0.42 to 1.84.|Baseline and six weeks post hyperbaric exposure series|one subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759459|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Processing Speed|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The Processing Speed score demonstrates improvement as the score increases. The score range was 9.7 to 52.4.|Baseline and six weeks post hyperbaric exposure series|one subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759460|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Visual Memory|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The visual memory score demonstrates improvement as the score increases. The score range was 31.2 to 92.7.|Baseline and six weeks post hyperbaric exposure series||||units on a scale||Standard Deviation|Mean
2759461|NCT00810615|Primary|Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores|"The PCL-M is a self reported test in which a list of 17 problems and complaints are offered to the individual to score on a 1 to 5 scale with 1 designating not at all, 2= a little bit, 3= moderately, 4= quite a bit and 5 designating extremely. A sample complaint would be repeated, disturbing dreams of a stressful military experience. Hence there is a possible total score range from 17 to 85. For military members, a score of 50 or above is indicative of PTSD. A change from baseline of 5-9 represents a reliable change and change of 10 or greater is a significant change."|baseline compared to the change at post hyperbaric exposures (30) series and the six weeks post hyperbaric exposure series|Per protocol. The study was a pilot.|||units on a scale||Standard Deviation|Mean
2759462|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Verbal Memory|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.|Baseline and six weeks post hyperbaric exposure series|one subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
2759463|NCT00810602|Secondary|Percent Survival at 2-years|To determine 2-year overall survival rate|two years|evaluable subjects|||percentage of subjects|||Number
2759464|NCT00810602|Secondary|Percent Cumulative Incidence of Relapse at 2 Years.|Determine the cumulative incidence of relapse at 2 years.|two years|evaluable subjects|||percentage of participants|||Number
2759465|NCT00810602|Secondary|Number of Serious Adverse Events|The safety and feasibility will be partially measured by the number of serious adverse events (SAE) recorded by participants receiving at least one dose of Vorinostat.|100 days|The number of patients who received at least one dose of vorinostat.|||Number of Serious Adverse Events|||Number
2759466|NCT00810602|Primary|100-day Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Assess if the addition of Vorinostat to standard GVHD prophylaxis regimen can reduce the rate of grades 2-4 acute GVHD when compared to 48% in a cohort of identically treated RIC HSCT patients without vorinostat. A reduction of incidence to less than 25% will be considered successful.|100 days|evaluable|||percentage of participants|||Number
2759467|NCT00810576|Primary|Number of Patients With Response|Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.|Every two 21-day cycles|No analysis done due to early termination resulting from low accrual.|||participants|||Number
2759468|NCT00810511|Primary|Comfort at End of Day|Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 4 weeks of wear|One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.|||Scale of 1-10||Standard Deviation|Mean
2759469|NCT00810446|Primary|Clinical Response Rate (Therapeutic) by Diagnosis|Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by diagnosis were counted to assess whether it contributed to clinical response.|6.5 years (at maximum)|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as indeterminable (n=10) at the final observation were excluded."|||Percentage of Participants|||Number
2759470|NCT00810446|Primary|Clinical Response Rate (Therapeutic) by Age|Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by age were counted to assess whether it contributed to clinical response.|6.5 years (at maximum)|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as indeterminable (n=10) at the final observation were excluded."|||Percentage of Participants|||Number
2759471|NCT00810446|Primary|Clinical Response Rate (Therapeutic) by Gender|Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response. Participants who achieved clinical response by gender were counted to assess whether it contributed to clinical response.|6.5 years (at maximum)|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as indeterminable (n=10) at the final observation were excluded."|||Percentage of Participants|||Number
2759505|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30||||ng*h/ml||Standard Deviation|Mean
2759523|NCT00810277|Secondary|Percentage of Participants Who Discontinued the Study||Up to Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
2759472|NCT00810446|Primary|Clinical Response Rate (Therapeutic)|Clinical response rate was defined as the percentage of participants who achieved clinical response over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical efficacy of MYCOBUTIN Capsules were determined by the investigator at the final observation point based on clinical symptoms and examinations, according to the following categories: (1) markedly improved, (2) improved, (3) slightly improved (4) unchanged, (5) aggravated, or (6) indeterminable. The participants assessed as (1) markedly improved and (2) improved were considered to have achieved clinical response.|6.5 years (at maximum)|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at the final observation point. Participants assessed as indeterminable (n=10) at the final observation were excluded."|||Percentage of Participants||95% Confidence Interval|Number
2759473|NCT00810446|Primary|Number of Participants With Adverse Drug Reactions by Diagnosis|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by diagnosis to assess whether it was a risk factor for the ADR.|6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.|||Participants|||Number
2759474|NCT00810446|Primary|Number of Participants With Adverse Drug Reactions by Age|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by age to assess whether it was a risk factor for the ADR.|6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.|||Participants|||Number
2759475|NCT00810446|Primary|Number of Participants With Adverse Drug Reactions by Gender|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Participants with ADRs were counted by gender to access whether it was a risk factor for the ADR.|6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.|||Participants|||Number
2759476|NCT00810446|Primary|The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. Relatedness to MYCOBUTIN Capsules was assessed by the physician. Expectedness of the adverse drug reaction was determined according to the Japanese package insert.|6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.|||Participants|||Number
2759477|NCT00810446|Primary|Number of Patients With Adverse Drug Reactions in This Surveillance|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to MYCOBUTIN Capsules in a participant who received MYCOBUTIN Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to MYCOBUTIN Capsules was assessed by the physician.|6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received MYCOBUTIN Capsules at least once.|||Participants|||Number
2759478|NCT00810407|Primary|Clinical Efficacy Rate by Age|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness."|1 year|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
2759479|NCT00810407|Primary|Clinical Efficacy Rate by Gender|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness."|1 year|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
2759506|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16||||ng*h/ml||Standard Deviation|Mean
2759538|NCT00810264|Secondary|Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint|Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.|5 years||||Percent of subjects|||Number
2759480|NCT00810407|Primary|Clinical Efficacy Rate by Diagnosis|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness."|1 year|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants||95% Confidence Interval|Number
2759481|NCT00810407|Primary|Clinical Efficacy Rate|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values."|1 year|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once.|||Percentage of Participants||95% Confidence Interval|Number
2759482|NCT00810407|Primary|Number of Participants With Treatment-Related Adverse Events by Age|A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events.|1 year|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once.|||Participants|||Count of Participants
2759483|NCT00810407|Primary|Number of Participants With Treatment-Related Adverse Events by Gender|A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events.|1 year|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once.|||Participants|||Count of Participants
2759484|NCT00810407|Primary|Number of Participants With Treatment-Related Adverse Events by Diagnosis|A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events.|1 year|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once.|||Participants|||Count of Participants
2759485|NCT00810407|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator.|1 year|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once.|||Participants|||Count of Participants
2759486|NCT00810407|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator.|1 year|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Mycobutin at least once.|||Participants|||Count of Participants
2759487|NCT00810394|Secondary|Time to Disease Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||95% Confidence Interval|Median
2759488|NCT00810394|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).|At least 3 months|Of the 34 patients who were evaluable for treatment response by RECIST, no responses were observed.|||Participants|||Count of Participants
2759489|NCT00810394|Primary|Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity|Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.|At least 3 months||||Participants|||Count of Participants
2759490|NCT00810368|Primary|Incremental Change in SF36 General Health Between Baseline and Week 12|Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
2759491|NCT00810368|Primary|Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12|Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
2759492|NCT00810368|Primary|SF36 Bodily Pain|Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
2759493|NCT00810368|Primary|Incremental Change in Fatigue Score From Baseline to Week 12|Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
2759494|NCT00810368|Secondary|Digit Symbol Substitution (WAIS)|Digit Symbol Substitution (WAIS) test (Joy et al., 2000): Subjects were given a table of numerals with matching symbols, and a form with random numerals with open spaces. The objective was to write in as many symbols that corresponded to the random numerals within a 90 second period. Each subject was their own control. The outcome measure was the incremental change in this score between Week 0 and Week 12 (units on a scale). Higher scores indicate better performance.|Difference between Week 0 and Week 12 (end of study)|2 carnosine subjects had incomplete data.|||units on a scale||95% Confidence Interval|Mean
2759495|NCT00810368|Primary|Subjects With Improved Diarrhea Symptoms|Patients were given questionnaires assessing common symptom complaints of diarrhea.|Weeks 0 and 12|Participants with evaluable data at the end of the study.|||participants|||Number
2759496|NCT00810368|Primary|Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores|"CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, & Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36.~Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group."|Weeks 0 and 12|Significant numbers of subjects dropped out of both arms of the study. The primary reason given was perceived lack of efficacy.|||units on a scale||95% Confidence Interval|Mean
2759497|NCT00810355|Primary|Symptoms|Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.|6 months||||scores on a scale||Standard Deviation|Mean
2759498|NCT00810355|Primary|Work Quantity|Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.|6 months||||hours worked per week||Standard Deviation|Mean
2759499|NCT00810355|Primary|Work Quality|Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.|6 months||||scores on a scale||Standard Deviation|Mean
2759500|NCT00810342|Secondary|Accelerometer Collected Moderate to Vigorous Physical Activity|Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months|12-Months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii|||minutes per week moderate-to-vigorous PA||95% Confidence Interval|Mean
2759501|NCT00810342|Primary|Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months|Self reported minutes of moderate or vigorous physical activity per week after 12-months|12 months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii|||minutes per week moderate-to-vigorous PA||Inter-Quartile Range|Mean
2759502|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30||||ng/ml||Standard Deviation|Mean
2759503|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16||||ng/ml||Standard Deviation|Mean
2759504|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15||||ng/ml||Standard Deviation|Mean
2759508|NCT00810303|Primary|Cmax of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30||||ng/ml||Standard Deviation|Mean
2759509|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20||||ng/ml||Standard Deviation|Mean
2759510|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5||||ng/ml||Standard Deviation|Mean
2759511|NCT00810303|Primary|AUC0-24h of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30||||ng*h/ml||Standard Deviation|Mean
2759512|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20||||ng*h/ml||Standard Deviation|Mean
2759513|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5||||ng*h/ml||Standard Deviation|Mean
2759514|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30||||ng/ml||Standard Deviation|Mean
2759515|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16||||ng/ml||Standard Deviation|Mean
2759516|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15||||ng/ml||Standard Deviation|Mean
2759517|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30||||ng*h/ml||Standard Deviation|Mean
2759518|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16||||ng*h/ml||Standard Deviation|Mean
2759519|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15||||ng*h/ml||Standard Deviation|Mean
2759520|NCT00810277|Secondary|Neutrophil Count||Baseline, Weeks 4, 8, and 12|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||E^9 per liter||Standard Deviation|Mean
2759521|NCT00810277|Secondary|Percentage of Participants With Lipid Level Elevations|Low density lipoprotein (LDL) level was categorized as 'Optimal (less than [<] 100 milligram per deciliter [mg/dL])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as 'Acceptable (40-59 mg/dL)', 'High (>=60 mg/dL)'. Total cholesterol (TC) level was categorized as 'Desirable (<200 mg/dL)', 'Borderline High (200-239 mg/dL)', 'High (>=240 mg/dL)'.|Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
2761513|NCT00795951|Primary|Diagnostic Performance: Mercapto Mix|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2759524|NCT00810277|Secondary|Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||millimeter per hour (mm/h)||Standard Deviation|Mean
2759525|NCT00810277|Secondary|C-Reactive Protein (CRP) Level||Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||milligram per liter (mg/L)||Standard Deviation|Mean
2759526|NCT00810277|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response|ACR20, ACR50, and ACR70 response: greater than or equal to (>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do).|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||percentage of participants|||Number
2759527|NCT00810277|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||percentage of participants|||Number
2759528|NCT00810277|Secondary|Disease Activity Score (DAS28)|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||units on a scale||Standard Deviation|Mean
2759529|NCT00810277|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Baseline up to Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
2759530|NCT00810264|Secondary|Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model|Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.|5 years|The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.|||percentage of subjects||95% Confidence Interval|Number
2759531|NCT00810264|Secondary|Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model|Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.|5 years|The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.|||percentage of subjects||95% Confidence Interval|Number
2759532|NCT00810264|Secondary|Impedance Measurements Per Corox BP LV Lead Model|Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.|5 years||||ohms||Standard Deviation|Mean
2759533|NCT00810264|Secondary|Sensing Measurements Per Corox BP LV Lead Model|Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.|5 years||||mV||Standard Deviation|Mean
2759534|NCT00810264|Secondary|Pacing Threshold Measurements Per Corox BP LV Lead Model|Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.|5 years||||V||Standard Deviation|Mean
2759535|NCT00810264|Secondary|Corox BP LV Lead Impedance Measurements|Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.|5 years||||ohms||Standard Deviation|Mean
2759536|NCT00810264|Secondary|Corox BP LV Lead Sensing Measurements|Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.|5 years||||mV||Standard Deviation|Mean
2759537|NCT00810264|Secondary|Corox BP LV Lead Pacing Threshold Measurements|Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.|5 years||||V||Standard Deviation|Mean
2759539|NCT00810264|Secondary|Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.|Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.|5 years|The subjects analyzed in this outcome must have been consented, implanted with a BIOTRONIK Corox BP LV lead, and completed an in-office 5 year visit. Subjects who did not complete an in-office 5 year visit are excluded from this analysis population.|||percentage of CRT pacing||Standard Deviation|Mean
2759540|NCT00810264|Primary|Percentage of Subjects Experiencing Individual Complications|Evaluation of the individual types of serious adverse events contributing to primary outcome 1.|5 years|The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.|||percentage of subjects||95% Confidence Interval|Number
2759541|NCT00810264|Primary|Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead|The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).|5 years|The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.|||percentage of subjects||95% Confidence Interval|Number
2759542|NCT00810199|Secondary|Time to Restart of Treatment After Discontinuation/Remission|The time in days from treatment discontinuation or remission to the restart of treatment.|104 Weeks|Participants from the intent-to-treat population, all participants who received study drug, with data available for analysis. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response had not been observed.|||Days||95% Confidence Interval|Median
2759543|NCT00810199|Secondary|Time to Flare After Tocilizumab Remission|The time in days to a flare (recurrence of disease symptoms) after the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.|||Days||Full Range|Median
2759544|NCT00810199|Secondary|Time to Drug-Free Remission|The time in days from initial study drug treatment to drug free remission that occurred when the participant was able to discontinue tocilizumab, methotrexate/placebo and open label disease-modifying antirheumatic drugs (DMARDS).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.|||Days||Full Range|Median
2759545|NCT00810199|Secondary|Time to Tocilizumab Remission|The time in days from initial study drug treatment to tocilizumab remission that occurred when the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.|||Days||Full Range|Median
2759546|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 52 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].Area under the curve for ACR response to Week 52 averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (<=5.5 and >5.5) as fixed factors.|Baseline to Week 52|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.|||Score on a scale*day||Standard Error|Least Squares Mean
2759547|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 24 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. Area under the curve for ACR response to Week 24 was averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.|Baseline to Week 24|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.|||Score on a scale*day||Standard Error|Least Squares Mean
2759548|NCT00810199|Secondary|Change From Baseline in Academic Medical Center (AMC) Linear Disability Scale (ALDS)|The Academic Medical Center (AMC) Linear Disability Score (ALDS) evaluates the participant's ability to perform activities of daily life consisting of 77 questions answered yes or no . The question difficulty and the patient's ability are arranged on a single hierarchical linear scale. ALDS scores range from 10 to 90 with a higher score representing higher functional status. A positive change from Baseline indicated improvement.|Baseline, Weeks 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis.|||Score on a scale||Standard Deviation|Mean
2759560|NCT00810199|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm||Standard Deviation|Mean
2759549|NCT00810199|Secondary|Change From Baseline in Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)|The RAQoL is a disease specific patient-reported outcome measure that determines the effect rheumatoid arthritis has on a patient's quality of life consisting of 30 questions that are answered either yes=1 or no=0 for a total possible score ranging from 0 (best) to 30 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52, 104|Participants from the intent-to-treat Population, all participants who received study drug, with data available for analysis at the given time-point. The RAQoL score was administered in a subset of sites for which the questionnaire was available in the local language.|||Score on a scale||Standard Deviation|Mean
2759550|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Safety Reasons|Safety reasons were defined as adverse events, intercurrent illness or death. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759551|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Lack of Sufficient Therapeutic Response|Lack of Sufficient Therapeutic Response was defined as the patient not responding to the drug as expected.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759552|NCT00810199|Secondary|Percentage of Participants Discontinuing Tocilizumab Due to Remission|The percentage of participants who stopped treatment with tocilizumab due to remission.|Weeks 52, 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with non-missing DAS28 assessment.|||Percentage of participants|||Number
2759553|NCT00810199|Secondary|Change From Baseline in Erosion Score|A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. The maximum erosion score in the hands was 98 and in the feet 42 for a total possible score of 0 to 140. A lower number change from Baseline indicated a better score.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.|||Score on a scale||Standard Error|Least Squares Mean
2759554|NCT00810199|Secondary|Change From Baseline in Joint Space Narrowing Score|A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum scores for joint space narrowing (JSN) in the hands was 104 and in the feet 48 for a total possible score of 0 to 152. A lower change from Baseline indicated a better score. Analysis of covariance model included baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.|||Score on a scale||Standard Error|Least Squares Mean
2759555|NCT00810199|Secondary|Change From Baseline in Total Genant Modified Sharp Scores (GSS)|Radiographs were taken of each hand and foot at Baseline, Weeks 24, 52 and104 and were evaluated using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 98 and in the feet 42. The maximum scores for joint space narrowing (JSN) in the hands was104 and in the feet 48. The total score was the sum of scores for erosions and JSN. The maximum total modified GSS was 292. A lower number change from Baseline was better. Analysis of covariance model, with Baseline DAS28 as a covariate and treatment and site as fixed factors.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.|||Score on a scale||Standard Error|Least Squares Mean
2759556|NCT00810199|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at the given time-point.|||Score on a scale||Standard Deviation|Mean
2759557|NCT00810199|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
2759558|NCT00810199|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm/hr||Standard Deviation|Mean
2759559|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Pain (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm||Standard Deviation|Mean
2759561|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm||Standard Deviation|Mean
2759562|NCT00810199|Secondary|Change From Baseline in Tender Joint Count|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Joint count||Standard Deviation|Mean
2759563|NCT00810199|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Joint count||Standard Deviation|Mean
2759564|NCT00810199|Secondary|Percentage of Participants With Good or Moderate European League (EULAR) DAS28 Responses|"The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2.~EULAR Moderate response: DAS28 > 3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759565|NCT00810199|Secondary|Change From Baseline in DAS28 Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Score on a scale||Standard Deviation|Mean
2759566|NCT00810199|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2.|Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759567|NCT00810199|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 52|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759568|NCT00810199|Secondary|Area Under Curve (AUC) DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. AUC DAS28 was averaged over study days. Analysis of Covariance was adjusted for Baseline DAS28 as a covariate and treatment group and region as fixed factors. Higher calculated AUC values are worse (indicate higher disease activity).|Baseline to Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available at Baseline and Week 24.|||Score on a scale*week||Standard Error|Least Squares Mean
2759569|NCT00810199|Secondary|Time to First ACR90 Response|Time in days from first administration of study drug until ACR90 response. ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
2759602|NCT00810043|Secondary|Change in Ambulatory Status|Ambulatory status was assessed by subjective patient questionnaire.|Baseline and 48 hrs post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||participants|||Number
2759570|NCT00810199|Secondary|Time to First ACR70 Response|Time in days from first administration of study drug until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
2759571|NCT00810199|Secondary|Time to First ACR50 Response|Time in days from first administration of study drug until ACR50 response. ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate).|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
2759572|NCT00810199|Secondary|Time to First ACR20 Response|Time in days from first administration of study drug until ACR20 response. ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
2759573|NCT00810199|Secondary|Percentage of Participants With ACR90 Response|ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759574|NCT00810199|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759575|NCT00810199|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759576|NCT00810199|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759577|NCT00810199|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 24|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
2759578|NCT00810108|Primary|Lopinavir Area Under the Curve (AUC)|Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)|pre-dose, 1,2,4,6,8, and 12 hours post-dose|All subjects who completed the pharmacokinetic sampling visits with whole tablet administration were analyzed|||mg*hr/L||Inter-Quartile Range|Median
2759579|NCT00810095|Secondary|Number of Device-related Serious Adverse Events|Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.|Treatment to 90 days postprocedure|Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.|||events|||Number
2759580|NCT00810095|Primary|Clinical Success|Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.|90 days postprocedure|Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.|||percentage of participants|||Number
2759581|NCT00810095|Primary|Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.|"TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:~TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.|||percentage of participants|||Number
2759582|NCT00810095|Primary|Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.|"TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:~TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|All participants treated with the Test System|||percentage of participants|||Number
2759583|NCT00810082|Primary|Participants With at Least One Fall|Subjects who had at least one fall subsequent to treatment.|3 months||||participants|||Number
2759584|NCT00810069|Secondary|Number of Participants With Adverse Events (AEs)|The list of AEs is located in the Reported Adverse Event module.|Baseline through Week 16|Full Analysis Population|||participants|||Number
2759585|NCT00810069|Secondary|Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response||Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||participants|||Number
2759586|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Visits||Standard Deviation|Mean
2759587|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Visits||Standard Deviation|Mean
2759588|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks|Only those participants who missed at least 1 hour of work due to depression were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Hours||Standard Deviation|Mean
2759589|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks|Only those participants who missed at least 1 hour of work were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Hours||Standard Deviation|Mean
2759590|NCT00810069|Secondary|Resource Utilisation - Number of Hours Worked Per Week||Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Hours||Standard Deviation|Mean
2759591|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission|Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population|||estimated probability (percent)||95% Confidence Interval|Mean
2759592|NCT00810069|Primary|Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population|||weeks||95% Confidence Interval|Median
2759593|NCT00810069|Secondary|Sheehan Disability Scale (SDS) Normal Functioning Total Score|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
2759594|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score|The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
2759595|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score|The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
2759596|NCT00810069|Secondary|Visual Analog Scale (VAS) - Overall Pain Severity|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
2759597|NCT00810069|Secondary|Clinical Global Impressions of Severity (CGI-S) Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
2759598|NCT00810069|Secondary|Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population|||weeks||95% Confidence Interval|Median
2759599|NCT00810069|Secondary|Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population|||weeks||95% Confidence Interval|Median
2759600|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response|Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population|||estimated probability (percent)||95% Confidence Interval|Mean
2759601|NCT00810069|Primary|Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Set|||weeks||95% Confidence Interval|Median
2759604|NCT00810043|Secondary|Deformity Correction Assessed by Local Cobb Angle (LCA)|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||degree||Standard Deviation|Mean
2759605|NCT00810043|Secondary|Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||degree||Standard Deviation|Mean
2759606|NCT00810043|Secondary|Amount of Vertebra Body Height (VBH) Gained by Postural Reduction||baseline and intra-operative|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||mm||Standard Deviation|Mean
2759607|NCT00810043|Secondary|Amount of Vertebral Body Height (VBH) Gained From IBTs Alone|Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.|Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||mm||Standard Deviation|Mean
2759608|NCT00810043|Secondary|Index Vertebral Body Height Restored in Millimeters.|Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.|Baseline and 48 hours after procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||mm||Standard Deviation|Median
2759609|NCT00810043|Primary|Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)||Baseline and 48-hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment|||percent change||Standard Deviation|Mean
2759610|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
2759611|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
2759612|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
2759613|NCT00809965|Secondary|The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
2759614|NCT00809965|Primary|The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
2759615|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)|To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the ABPM substudy and who met the study inclusion and exclusion criteria for randomization.|||mm Hg||Standard Deviation|Mean
2759616|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).|To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the Ambulatory Blood Pressure Monitoring (ABPM) substudy and who met the study inclusion and exclusion criteria for randomization.|||mm Hg||Standard Deviation|Mean
2759617|NCT00809926|Other Pre-specified|Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8|To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)|Baseline through week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||mm Hg||Standard Error|Least Squares Mean
2759618|NCT00809926|Other Pre-specified|Completers Analysis for Change From Baseline in MSSBP at Week 8|To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population - patients who completed the double-blind treatment period.|Baseline to week 8|The analysis included ITT patients who completed the double-blind treatment period [those patients with a final observation at week 8, also known as observed cases (OC)]. This analysis differed from the ITT-LOCF analysis, in that it did not include patients who discontinued from the trial prematurely.|||mm Hg||Standard Deviation|Mean
2759619|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8|To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||ng/L||Standard Deviation|Mean
2759620|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8|To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||ng/mL/h||Standard Deviation|Mean
2759621|NCT00809926|Secondary|Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8|To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||percentage of responders|||Number
2759622|NCT00809926|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8|To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||percentage of patients|||Number
2759623|NCT00809926|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.|||mm Hg||Standard Deviation|Mean
2759624|NCT00809926|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.|||mm Hg||Standard Deviation|Mean
2759625|NCT00809848|Secondary|Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.|Baseline, Day 14|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation|||Percentage of Patients|||Number
2759687|NCT00809341|Primary|Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan||2 years|The study was placed on hold to determine a quantitative method for the evaluation of PET scan results. No decision was reached on the evaluation mechanism for the PET scans, so the study was terminated. Data for this outcome was not collected because a standardized evaluation mechanism for the PET scans was not found.||||||
2759626|NCT00809848|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2759627|NCT00809835|Secondary|Cognitive Function|"A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span).~Scores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning."|12 weeks|All participants did not complete the CANTAB assessments at both pre and post treatment. Reasons for not completing were refusal to complete the tasks, inability to complete the tasks in a manner in which they could be scored and equipment or computer problems.|||scores on a scale||Standard Deviation|Mean
2759628|NCT00809835|Primary|Cocaine Abstinence|operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks|12 weeks|Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment.|||percentage of negative urines||Standard Deviation|Mean
2759629|NCT00809835|Primary|Cocaine Use|Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.|12 weeks|Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks.|||Days||Standard Deviation|Mean
2759630|NCT00809809|Secondary|Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.||14 days|||||||
2759631|NCT00809809|Primary|Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.|Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.|14 days|5 subjects met exclusion criteria and were excluded from analysis. 2 subjects used concomitant medications and were excluded from the final analysis. Twelve subjects with recurrent HSL enrolled twice, only the 1st enrollment was included in the analysis. 2 subjects had family enroll who were excluded from analysis. Analysis - 134 subjects.|||Days to resolution||95% Confidence Interval|Median
2759632|NCT00809757|Secondary|Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score|The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.|Visit 3 and Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Units on a scale||Standard Deviation|Mean
2759633|NCT00809757|Secondary|Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used||Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline|||Doses per Week||Standard Deviation|Mean
2759634|NCT00809757|Secondary|Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population|||Doses per Week||Standard Deviation|Mean
2759635|NCT00809757|Secondary|Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline|||Days per Week||Standard Deviation|Mean
2759636|NCT00809757|Secondary|Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period|Number of subjects using rescue medication during the treatment period|Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population|||Number of subjects|||Number
2759637|NCT00809757|Secondary|Caregiver Global Assessment - Question 3|Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
2759638|NCT00809757|Secondary|Caregiver Global Assessment - Question 2|Since the start of the study, how would you evaluate your ability to manage your child's asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
2759639|NCT00809757|Secondary|Caregiver Global Assessment - Question 1|Since the start of the study, how would you evaluate your child's asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
2759640|NCT00809757|Secondary|Investigator Global Assessment - Question 2|Since the start of the study, how would you evaluate your ability to manage the subject's asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
2759641|NCT00809757|Secondary|Investigator Global Assessment - Question 1|Since the start of the study, how would you evaluate the child's asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
2761514|NCT00795951|Primary|Diagnostic Performance: Formaldehyde|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2759642|NCT00809757|Secondary|Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
2759643|NCT00809757|Secondary|Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Baseline, Visit 3 (the week prior to Visit 3) and Visit 4|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
2759644|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4||Baseline, Visit 4, pre -dose (approximately 28 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
2759645|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3||Baseline, Visit 3, pre -dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
2759646|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2||Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
2759647|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4||Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
2759648|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3||Baseline, Visit 3, pre-dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
2759649|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2|Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort|Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
2759650|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759651|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759652|NCT00809757|Secondary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759653|NCT00809757|Secondary|Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759654|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759655|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759656|NCT00809757|Secondary|Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
2759657|NCT00809757|Primary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis|||units on a scale||Standard Deviation|Mean
2759658|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||Liters||Standard Deviation|Mean
2759659|NCT00809614|Secondary|PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||day*ug/mL||Standard Deviation|Mean
2759660|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||ug/mL||Standard Deviation|Mean
2759661|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||day||Standard Deviation|Mean
2759662|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||Liters/day||Standard Deviation|Mean
2759663|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic ( PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||Day||Full Range|Median
2759664|NCT00809614|Secondary|Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment|The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.|Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Units on a scale||Standard Deviation|Mean
2759665|NCT00809614|Secondary|Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment|The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|Only participants from the pharmacodynamic (PD) analysis set, who had available scores at each given time point, were analyzed for that time point. The PD analysis set included all patients with evaluable PD data with no protocol deviations that impacted PD data analysis.|||total score||Standard Deviation|Mean
2759666|NCT00809614|Secondary|SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment|SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Unit on a scale||Standard Deviation|Mean
2759667|NCT00809614|Secondary|Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Unit on a Scale||Standard Deviation|Mean
2759668|NCT00809614|Secondary|Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment|The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Units on a scale||Standard Deviation|Mean
2759669|NCT00809614|Secondary|Percentage of Participants Who Achieved PsARC Response|"responder defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.|||Percentage of participants|||Number
2759670|NCT00809614|Secondary|Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocoldeviations.|||Percentage of particpants|||Number
2759671|NCT00809614|Primary|Percentage of PsARC Responders Per Treatment at Week 6|"Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity~A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.|||Percentage of PsARC responders|||Number
2759672|NCT00809614|Primary|Percentage of ACR Responders Per Treatment at Week 6|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.|||Percentage of ACR responders|||Number
2759673|NCT00809523|Primary|Percentage Change SIGH SAD Depression Rating|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.~Calculated: SIGH SAD score at trial end - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization"|4 weeks|Intent to treat analysis last observation carried forward.|||percentage of change on SIGH SAD||Standard Deviation|Mean
2759674|NCT00809523|Secondary|Clinical Global Impression of Severity|The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.|Randomization and at 4 weeks|intent to treat analysis|||units on a scale||Standard Deviation|Mean
2759727|NCT00809146|Secondary|Number of Subjects Admitted to an Intensive Care Unit (ICU)|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at time of disposition on day of enrollment||||participants|||Number
2759675|NCT00809523|Secondary|SIGH SAD Depression Rating|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly|Intent to treat analysis last observation carried forward.|||units on a scale||Standard Deviation|Mean
2759676|NCT00809471|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Deviation|Least Squares Mean
2759677|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 Weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
2759678|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12-weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
2759679|NCT00809458|Secondary|Determine Concordance of the Biomarkers in This Setting|The correlation between the ATQ level and the androgen receptor will be explored.|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.||||||
2759680|NCT00809458|Secondary|Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.|"Cardiovascular Effects/ Thrombophlebitis~Dermatologic Effects~Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)~Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production~Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)~Neurologic Effects (Dizziness, headache, fatigue or weakness~Ophthalmic Effects ( Blurred vision)~Respiratory Effects (Pulmonary embolism)"|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.||||||
2759681|NCT00809458|Primary|Reduce Biomarkers of Prostate Cancer (PSA Blood Level)|PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.|30 days|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.||||||
2759682|NCT00809445|Secondary|Self-Report of Ever Having Been Tested|The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.|1 month post-randomization|Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively|||participants|||Number
2759683|NCT00809445|Secondary|Sharing of Needles Used in Drug Use|Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.|Six months||||n of people changing needle sharing|||Number
2759684|NCT00809445|Primary|Number of Risky Sexual Behaviors|The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).|Six months post-randomization|All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.|||number of unprotected sex acts||Standard Deviation|Mean
2759685|NCT00809445|Primary|Self-Report Receipt of HIV Test Results|The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.|One month post-randomization|All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively|||participants|||Number
2759686|NCT00809341|Secondary|Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.||5 years|The study was placed on hold to determine a quantitative method for the evaluation of PET scan results. No decision was reached on the evaluation mechanism for the PET scans, so the study was terminated. Data for this outcome was not collected because a standardized evaluation mechanism for the PET scans was not found.||||||
2759688|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."|||percentageof participants||95% Confidence Interval|Number
2759689|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2759690|NCT00809328|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.|Day 3|Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.|||participants|||Number
2759691|NCT00809328|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100"|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2759692|NCT00809328|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2759693|NCT00809276|Primary|To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD|Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.|1 year||||percentage of participants||95% Confidence Interval|Number
2759694|NCT00809185|Other Pre-specified|Laboratory Correlates (Cytotoxic T-cell Populations, S6K1 Levels, GSTT-1 Mutations, and Presence or Absence of HLA-DR15)|T-cell populations in patients pre- and post-treatment|at 2 years of treatment|||||||
2759695|NCT00809185|Secondary|Number of Participants With Bone Marrow Morphology and Cytogenetics Pre- and Post-therapy|Number of Participants with change in bone marrow morphology and cytogenetics|at 2 years of treatment|All patients enrolled and given treatment.|||Participants|||Count of Participants
2759696|NCT00809185|Secondary|Number of Dose- and Non-dose-limiting Toxicities|Number of Dose- and Non-dose-limiting Toxicities at the end of cycle 1 associated with RAD001 (see AE/SAE section for details).|at end of one cycle (28 days)|All patients enrolled and given treatment.|||events|||Number
2759697|NCT00809185|Primary|Number of Patients With Either a Major or Minor Erythroid Response (Hemoglobin Change From Baseline Measure)|"Major erythroid response: (1) For patients with a baseline hemoglobin less than 11 g/dL, a major erythroid response is defined as a > 2 g/dL increase in hemoglobin from baseline; or (2) 100% decrease in red blood cell transfusion requirements.~Minor erythroid response: (1) For patients with baseline hemoglobin less than 11 g/dL, a minor erythroid response is defined as an increase in hemoglobin greater than 1 g/dL but less than 2 g/dL from baseline; or (2) > 50% decrease in red blood cell transfusion requirements."|2 years of treatment|All patients enrolled and given treatment.|||participants|||Number
2759698|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.|"The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
2759728|NCT00809146|Secondary|Number of Subjects Hospitalized|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at ED disposition on day of enrollment||||participants|||Number
2759699|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.|"The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
2759700|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Day 8,15,29,week, 6, 10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
2759701|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Score||Standard Deviation|Mean
2759702|NCT00809159|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2|The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad.|Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||95% Confidence Interval|Least Squares Mean
2759703|NCT00809159|Secondary|Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement|Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
2759704|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day||Standard Deviation|Mean
2759705|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day||Standard Deviation|Mean
2759706|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters||Standard Deviation|Mean
2759743|NCT00809133|Secondary|Part B: Bevacizumab Plasma Concentration|Bevacizumab plasma concentration after infusion of Bevacizumab 5mg/kg after end of 1st and 2nd infusion in Cycle 1.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||μg/mL||Inter-Quartile Range|Median
2759707|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters||Standard Deviation|Mean
2759708|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters/day||Standard Deviation|Mean
2759709|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters/day||Standard Deviation|Mean
2759710|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day*ug/mL||Standard Deviation|Mean
2759711|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day*ug/mL||Standard Deviation|Mean
2759712|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||ug/mL||Standard Deviation|Mean
2759713|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||ug/mL||Standard Deviation|Mean
2759714|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.|||Days||Full Range|Median
2759715|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.|||Days||Full Range|Median
2759716|NCT00809159|Secondary|Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1|The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation|Baseline, week 6, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Score||Standard Deviation|Mean
2761515|NCT00795951|Primary|Diagnostic Performance: p-Phenylenediamine|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2759717|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined|a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data|Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Participants|||Number
2759718|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1|ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Participants|||Number
2759719|NCT00809159|Primary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2|ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
2759720|NCT00809159|Primary|Percentage of Participants Who Achieved ASAS20 Response|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Percentage|||Number
2759721|NCT00809146|Secondary|Length of Hospital Stay in Days|Continuous acute care inpatient hospital days from day of admission until discharge|participants were followed for the duration of hospital stay, an average of 6 days|All subjects with hospital length of stay data|||days||Standard Deviation|Mean
2759722|NCT00809146|Secondary|Length of Intensive Care Unit (ICU) Stay in Days|Continuous days of initial ICU stay from time of admission|participants were followed for the duration of hospital stay, an average of 6 days|All participants with ICU length of stay data|||days||Standard Deviation|Mean
2759723|NCT00809146|Secondary|Number of Subjects With IV Injection-site Complications|IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care.|participants were followed for the duration of hospital stay, an average of 6 days||||participants|||Number
2759724|NCT00809146|Secondary|Number of Subjects With IM Injection-site Complications|IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems.|participants were followed for the duration of hospital stay, an average of 6 days||||participants|||Number
2759725|NCT00809146|Secondary|Number of Subjects With Hypotension|Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor.|participants were followed for the duration of hospital stay, an average of 6 days||||participants|||Number
2759726|NCT00809146|Secondary|Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival|Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival.|within 12 hours after ED arrival||||participants|||Number
2760004|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).|baseline||||Z-score||Standard Deviation|Mean
2759729|NCT00809146|Secondary|Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival|Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation.|anytime before 30 minutes after ED arrival||||participants|||Number
2759730|NCT00809146|Primary|Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given|The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.|Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).||||participants|||Number
2759731|NCT00809133|Secondary|Objective Tumour Response (Confirmed)|"Number of subjects with confirmed objective tumour response.~Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR). Objective response was to be confirmed by a second tumour assessment at least 4 weeks after the assessment of CR or PR."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
2759732|NCT00809133|Secondary|Objective Tumour Response (Unconfirmed)|"Number of subjects with objective tumour response (unconfirmed).~Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR)."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
2759733|NCT00809133|Secondary|Part D: Carboplatin Cmax in Cycle 1 and 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759734|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759735|NCT00809133|Secondary|Part D: Paclitaxel Cmax in Cycle 1 and 2|Maximum measured concentration of Paclitaxel in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759736|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 23 Hours in Cycle 1 and Cycle 2|AUC0-23: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 23 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 23:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759737|NCT00809133|Secondary|Part D: Afatinib Cmax,ss|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759738|NCT00809133|Secondary|Part D: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State.|AUCt,ss: Area under the concentration-time curve of Afatinib at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759739|NCT00809133|Secondary|Part C: Carboplatin Cmax in Cycle 1 and Cycle 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759740|NCT00809133|Secondary|Part C: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759741|NCT00809133|Secondary|Part C: Afatinib Cmax,ss in Cycle 2|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759742|NCT00809133|Secondary|Part C: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State in Cycle 2|AUCt,ss: Area under the concentration-time curve of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2760005|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|Baseline||||inches||Standard Deviation|Mean
2759744|NCT00809133|Secondary|Part B: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759745|NCT00809133|Secondary|Part B: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759746|NCT00809133|Secondary|Part B: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759747|NCT00809133|Secondary|Part B: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. There were no analyzable patients for Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759748|NCT00809133|Secondary|Part A: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759749|NCT00809133|Secondary|Part A: AUC0-24: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From Zero Extrapolated to 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759750|NCT00809133|Secondary|Part A: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2759751|NCT00809133|Secondary|Part A: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2759752|NCT00809133|Secondary|Incidence and Intensity of AEs According to the Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade|Incidence and Intensity of AEs (Adverse Events) graded according to the maximum CTCAE (Common Toxicity Criteria for Adverse Events) grade based on the number of patients with AEs with CTCAE Grade 1-5.|From first drug administration until the end of treatment cycle 1; 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
2759753|NCT00809133|Primary|Maximum Tolerated Dose (MTD)|"The MTD of afatinib in selected combination treatments was defined as the highest dose at which no more than 1 out of 6 patients experienced DLTs during the first treatment cycle, i.e. the highest dose with a DLT incidence ≤17%. The MTD was determined separately for Afatinib in combination with Paclitaxel (part A), Afatinib in combination with Paclitaxel and Bevacizumab (part B), Afatinib and Carboplatin (part C), and Afatinib in combination with Paclitaxel and Carboplatin (part D).~In part C, dose escalation was not continued beyond the dose level A40C6, due to safety and pharmacokinetic considerations and upon mutual agreement between the investigators and the sponsor. Formally, no MTD was determined, however a recommended phase II dose was determined and is presented here.~0=not maximum tolerated dose, 1=is maximum tolerated dose~Note, the depicted order of treatment groups is driven by dose level, not by the actual dosing steps."|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Units on a scale|||Number
2759754|NCT00809133|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) was defined as an Adverse Event (AE) or laboratory abnormality considered as related to study treatment.|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
2759755|NCT00809094|Other Pre-specified|Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group|Change in measure of estimated right ventricular pressure over the 24-week study period|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects. 1 subject in NAC cohort has missing data. It was not imputed|||mm Hg||Standard Deviation|Mean
2759756|NCT00809094|Other Pre-specified|Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group|Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study.|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects.|||ml/min/mm Hg||Standard Deviation|Mean
2759774|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist|||percent|||Number
2759757|NCT00809094|Secondary|FEF 25-75% (Percent of Predicted)|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks).|Baseline to 24 weeks|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||percent of predicted||95% Confidence Interval|Mean
2759758|NCT00809094|Secondary|FEF 25-75% (L/Sec)|Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study.|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||L/sec||95% Confidence Interval|Mean
2759759|NCT00809094|Secondary|FEV1 (L)|Forced expiratory volume in 1 second (Liters)|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||Liter||95% Confidence Interval|Number
2759760|NCT00809094|Secondary|Change in FEV1 (Percent of Predicted for Age)|Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted)|From enrollment to the end of the 24-week trial|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||percent of predicted vlaues||95% Confidence Interval|Number
2759761|NCT00809094|Primary|Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum|(change in log10 HNE in the active treatment group) - (change in log10 HNE in the placebo group)|From enrollment to end of the 24-week trial|The primary endpoint analyses described uses the subset of the ITT population with complete case data. 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||log10 mcg/mL||95% Confidence Interval|Log Mean
2759762|NCT00809055|Secondary|Bayley Scales of Infant Development Cognitive Score at 2 Years of Age|The cognitive portion of the Bayley Scales of Infant Development assesses development in infants and toddlers between the ages of 0 and 3 years. Raw scores are converted to scale scores. A scale score of 100 is designed to represent the population mean. Scores below 100 represent developmental delay relative to the mean and scores above 100 represent advanced development relative to the mean.|2 years|13 patients excluded from high-dose group (7 died, 2 withdrew, 2 we were unable to contact, 2 did not comply with scheduled appointments). 15 patients excluded from standard-dose group (5 died, 2 withdrew, 5 we were unable to contact, 3 did not comply with scheduled appointments).|||score||Standard Deviation|Mean
2759763|NCT00809055|Secondary|Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge|The Dubowitz Neurologic Examination is a standardized neurologic examination for infants at term age. It includes 6 compound optimality scores summed to obtain the total optimality score. Compound optimality scores include tone (range 0-10), tone pattern (range 0-5), reflexes (range 0-6), movements (range 0-3), abnormal signs (range 0-3), and behavior (range 0-7). The range for the compound optimality score is 0 - 34, with scores between 30.5 and 34 considered optimal and scores below 30.5 considered suboptimal.|Participants were followed for the duration of hospital stay, an average of 12 weeks|9 patients excluded from high-dose group (7 died, 2 withdrew). 6 patients excluded from standard-dose group (5 died, 1 transferred).|||scores on a scale||Standard Deviation|Mean
2759764|NCT00809055|Secondary|Evaluation of EEG Seizure Burden|For the first 72 hours of life, infants were monitored for seizures using continuous limited channel aEEG. Seizures were defined as a series of sharp waves, at least ten seconds in duration, which evolve in frequency, amplitude, and morphology over time and are clearly distinguishable from the background or artifact.|First 72 hours of life|7 patients excluded from high-dose group and 8 from standard-dose group due to recordings < 6 hours or corrupt data files.|||seconds||Standard Deviation|Mean
2759765|NCT00809055|Secondary|Rates of Retinopathy of Prematurity||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
2759766|NCT00809055|Secondary|Rates of Necrotizing Enterocolitis||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
2759767|NCT00809055|Secondary|Rates of Chronic Lung Disease|Defined as oxygen requirement at 36 weeks PMA|Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
2759768|NCT00809055|Secondary|Length of Time Requiring Invasive Respiratory Support||Participants were followed for the duration of hospital stay, an average of 12 weeks||||days||Inter-Quartile Range|Median
2759769|NCT00809055|Secondary|Cerebellar Hemorrhage||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
2759770|NCT00809055|Secondary|Mortality Rates||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
2759771|NCT00809055|Primary|White Matter Microstructural Maturation|Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.|Participants were followed for the duration of hospital stay, an average of 12 weeks|12 patients excluded from high-dose group (7 died, 2 withdrew, 3 insufficient image quality). 10 patients excluded from standard-dose group (5 died, 1 transferred, 1 parent refused MRI, 3 insufficient image quality).|||apparent diffusion coefficient||Standard Deviation|Mean
2759772|NCT00808899|Primary|Complete Response Plus Partial Response|The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.|10 years|The population consisted of patients eligible for enrollment onto the NB2008 protocol.||||||
2759773|NCT00808834|Primary|Comfort After Insertion|Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.|30-60 seconds after initial insertion|Per protocol|||Scale 1-10||Standard Deviation|Mean
2759837|NCT00808483|Secondary|Harris Hip Score (HHS)|Pain and physical function. 0 (worse) - 100 (best)|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
2759775|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist|||percent|||Number
2759776|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist|||percent|||Number
2759777|NCT00808808|Secondary|Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season||30Sep2008 through 23Dec2008|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not|||percent|||Number
2759778|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not|||percentage points|||Number
2759779|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees at participating sites, including those who completed surveys and those who did not|||percentage points|||Number
2759780|NCT00808808|Primary|Overall Vaccination Rate, Employees 18 to 49 Years of Age||30Sep2008 through 23Dec2008|All vaccinated employees at participating sites, including those who completed surveys and those who did not|||Percentage of participants|||Number
2759781|NCT00808808|Primary|Overall Vaccination Rate, All Ages||30Sep2008 through 23Dec2008|All employees at participating sites, including those who were vaccinated and those who were not|||Percentage of participants|||Number
2759782|NCT00808769|Primary|The Mean Percent Time Gastric pH > 4.0 on Day 1|In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.|continuously over a 24 hour period|Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was ~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH < 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.||||||
2759783|NCT00808665|Primary|Time Required After Surgery to Reach Fitness for Discharge From Hospital||Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)|analysis done on the 54 participants that received the entire course of Dexmedetomidine or placebo.|||days||Inter-Quartile Range|Median
2759784|NCT00808639|Secondary|Number of Patients Experiencing Surgery-related Toxicity|Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.|Surgery + 30 days|Number of patients who underwent cystectomy.|||participants||90% Confidence Interval|Number
2759785|NCT00808639|Secondary|Number of Patients Experiencing Febrile Neutropenia|Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)||||participants||90% Confidence Interval|Number
2759786|NCT00808639|Primary|Number of Patients Achieving Pathologic Response|Pathological response is defined as down-staging to </=pT1, N0 after chemotherapy with pegfilgrastim support.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)|Analysis population consists of all enrolled patients.|||percentage of pathologic responders||90% Confidence Interval|Number
2759787|NCT00808509|Secondary|Change From Baseline in Radiological Modified Total Sharp Score|The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 52, and Weeks 104-156|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2759788|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Daily Activities|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2759789|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Work Productivity|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2759838|NCT00808483|Secondary|Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)|Self-reported symptoms, pain, physical function, function in sport and recreation, quality of life. 0 (worse) - 100 (best)|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
2759790|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Worked|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days.|Baseline and at Weeks 12, 28, 52 and 104-156|Full analysis set participants employed or working for pay and with available data at each time point.|||hours||Standard Deviation|Mean
2759791|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.|||hours||Standard Deviation|Mean
2759792|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.|||hours||Standard Deviation|Mean
2759793|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Currently Employed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759794|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759795|NCT00808509|Secondary|Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759796|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759797|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759798|NCT00808509|Secondary|Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759799|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759800|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759801|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759802|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759803|NCT00808509|Secondary|Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759804|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759805|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759806|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759807|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759808|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759809|NCT00808509|Secondary|Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759810|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759811|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759812|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759813|NCT00808509|Secondary|Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759814|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759815|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Very Stiff at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759816|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
2759817|NCT00808509|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data.|||units on a scale||Standard Deviation|Mean
2759818|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2759819|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state:~Level 1: I am not anxious or depressed;~Level 2: I am moderately anxious or depressed;~Level 3: I am extremely anxious or depressed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
2759820|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state:~Level 1: I have no pain or discomfort;~Level 2: I have moderate pain or discomfort;~Level 3: I have extreme pain or discomfort."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
2759821|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities):~Level 1: I have no problems performing my usual activities;~Level 2: I have some problems performing my usual activities;~Level 3: I am unable to perform my usual activities."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
2759822|NCT00808509|Primary|Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set 2 (FAS2), defined as participants in the full analysis set who completed at least 28 weeks of the study or completed the study until flare, whichever occurs first.|||percentage of participants||95% Confidence Interval|Number
2759823|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state:~Level 1: I have no problems with self-care;~Level 2: I have some problems washing or dressing myself;~Level 3: I am unable to wash or dress myself."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
2759824|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state:~Level 1: I have no problems in walking about;~Level 2: I have some problems in walking about;~Level 3: I am confined to bed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
2759839|NCT00808483|Primary|6 Minutes Walk Test (6MWT)|Participants walked in a 40 meter hospital corridor for 6 minutes.|5 months and 12 months||||meters||95% Confidence Interval|Mean
2759852|NCT00808444|Secondary|Occurrence of Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following vaccination and throughout the entire study period (Month 0 to Month 4)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||subjects|||Number
2760006|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|up to 44 weeks||||inches||Standard Deviation|Mean
2759825|NCT00808509|Secondary|Health Assessment Questionnaire (HAQ) Total Score by Visit|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2759826|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare|For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.|||percentage of participants||95% Confidence Interval|Number
2759827|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare|"For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy).~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity."|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.|||percentage of participants||95% Confidence Interval|Number
2759828|NCT00808509|Secondary|Number of Participants With a Flare|Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|Full analysis set; N indicates the number of participants with available data at each time point.|||participants|||Number
2759829|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52."|Week 52|Full analysis set 2|||percentage of participants||95% Confidence Interval|Number
2759830|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission."|Week 52|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2759831|NCT00808509|Primary|Percentage of Participants in Remission at Week 28|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set (FAS), defined as all participants who received at least one dose of adalimumab and/or methotrexate and had at least one post-baseline observation.|||percentage of participants||95% Confidence Interval|Number
2759832|NCT00808483|Secondary|Figure-of-eight Test|Test of dynamic balance. Number of steps on and outside the line is registered. 0 (best)|5 months and 12 months||||steps||95% Confidence Interval|Mean
2759833|NCT00808483|Secondary|Index of Muscle Function (IMF)|Tests of general mobility, muscle strength, balance/coordination, and endurance. 40 (worse) - 0 (best)|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
2759834|NCT00808483|Secondary|ROM Extension|Active range of motion (ROM) in hip extension test. Degrees is registered. 0 degrees indicates zero position of the hip, minus digrees indicates flexion contracture.|5 months and 12 months||||degrees||95% Confidence Interval|Mean
2759835|NCT00808483|Secondary|Stair Climbing Test (ST)|Ascend and descend 8 steps with a step hight of 16 cm as fast as they could without running. Few seconds (best) - many seconds (worse)|5 months and 12 months||||seconds||95% Confidence Interval|Mean
2759836|NCT00808483|Secondary|Self-efficacy|Self-reported self-efficacy in activities. 0 (worse) - 100 (best).|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
2760007|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|baseline||||inches||Standard Deviation|Mean
2759840|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs|Distortion Product Otoacoustic Emission (DPOAE) Amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10dB lower than F1 Levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. The OAE testing began as soon as threshold testing completed. Threshold tests take approximately 15 min, but the exact duration of testing varies among subjects. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier than for others (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).|15 minutes|||||||
2759841|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures|DPOAE amplitude was measured following the audiometric testing completion at each of the post-music test times. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 3328 and 3984 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels.|repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|||||||
2759842|NCT00808470|Other Pre-specified|Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz||repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|||||||
2759843|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes|DPOAE amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. Test time was approximate as DPOAE tests began as soon as threshold testing was completed. F1 and F2 frequency pairs included 3328 and 3984 Hz, F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. Threshold tests take approximately 15 min, but the exact duration of testing varies from subject to subject. The OAE testing began as soon as threshold testing completed. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier or a little bit later (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).|15 min|Data for one participant in the placebo group is incomplete.|||decibels (dB)||Standard Deviation|Mean
2759844|NCT00808470|Secondary|Tinnitus|Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.|immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|all participants completing music exposure completed tinnitus surveys.|||participants|||Number
2759845|NCT00808470|Secondary|Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music|The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.|15 min|all participants that completed music exposure were assessed; two participants withdrew prior to music exposure.|||decibels||Standard Deviation|Mean
2759846|NCT00808470|Primary|Average Threshold Shift at 4 kHz in Both Ears|The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.|15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|All subjects that completed music exposure were analyzed; two subjects withdrew from study prior to music exposure.|||decibels||Standard Deviation|Mean
2759847|NCT00808444|Secondary|Occurrence of Unsolicited Adverse Events|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2759848|NCT00808444|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentrain was expressed as GMC in µg/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2759849|NCT00808444|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Concentrations are expressed as GMCs in EL.U/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Least Squares Mean
2759850|NCT00808444|Secondary|Number of Subjects With Solicited Local and General Symptoms.|"Solicited local symptoms were pain, redness and swelling.~Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting."|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which inlcuded all vaccinated subjects.|||Participants|||Count of Participants
2759851|NCT00808444|Secondary|Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes|"Titers are presented as Geometric Mean Titers (GMTs).~Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2759853|NCT00808444|Secondary|Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)|Concentration was expressed as GMC in units per milliliter (U/mL).|3 months after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||U/mL||95% Confidence Interval|Geometric Mean
2759854|NCT00808444|Secondary|Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).|Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete reanalysis.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2759855|NCT00808444|Secondary|Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)|Concentrations were defined as GMCs in international units per milliter (IU/mL)|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2759856|NCT00808444|Secondary|Poliovirus Types 1, 2 and 3 Titers|Titers were given as Geometric Mean Titers (GMTs).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2759857|NCT00808444|Secondary|Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes|"Opsonophagocytic titers were expressed as GMTs.~Cross-reactive pneumococcal serotypes included 6A and 19A."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2759858|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|"Cross-reactive pneumococcal serotypes were 6A and 19A.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2759859|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2759860|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL|Anti-pneumococcal cross-reactive serotypes were 6A and 19A.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2759861|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL|Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2759862|NCT00808444|Primary|Concentration of Antibody Against Protein D (PD)|Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2759863|NCT00808444|Primary|Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine|"Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL).~Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2759864|NCT00808405|Secondary|Time to First Negative Herpes Simplex Virus (HSV) DNA PCR|To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.|||Days||Standard Error|Mean
2759865|NCT00808405|Primary|Time to Healing of Genital Lesions|To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.|||Days||Standard Error|Mean
2759866|NCT00808340|Primary|Overall Subjective Vision|Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|after 1 week of lens wear, for each lens type||||Units on a scale||Standard Error|Least Squares Mean
2759867|NCT00808340|Primary|Type of Corneal Staining|Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).|after 1 week of lens wear, for each lens type||||Units on a scale||Standard Error|Least Squares Mean
2759868|NCT00808340|Primary|Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion||||logMAR||Standard Error|Least Squares Mean
2759869|NCT00808340|Primary|Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion||||logMAR||Standard Error|Least Squares Mean
2759870|NCT00808249|Secondary|Change in Sheehan Disability Scale (SDS) Global Total Score|The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)|From baseline ( randomization) to week 4||||Units on scale||Standard Error|Least Squares Mean
2759871|NCT00808249|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score|The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms|From baseline ( randomization) to week 4||||Units on scale||Standard Error|Least Squares Mean
2759872|NCT00808249|Secondary|Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score|The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.|From baseline (randomization) to week 4||||Unit on scale||Standard Error|Least Squares Mean
2759873|NCT00808249|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.|From randomization (baseline) to week 4||||Units on scale||Standard Error|Least Squares Mean
2759874|NCT00808249|Primary|Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.|From randomization (baseline) to week 4||||Units on scale||Standard Error|Least Squares Mean
2759875|NCT00808236|Post-Hoc|Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital||Hospital Discharge|Subset of patients that received EMS CPR within 10 minutes of collapse, achieved ROSC, and were subsequently admitted to the hospital.|||participants|||Number
2759876|NCT00808236|Post-Hoc|Outcomes for VF Patients Admitted to the Hospital|Survival and neurologically-intact survival for patients found in VF/VT admitted to the hospital|Hospital discharge|Subset of patients with an initial rhythm of VF/VT, achieved ROSC and were subsequently admitted to the hospital|||participants|||Number
2759877|NCT00808236|Post-Hoc|Outcomes for Patients Admitted to the Hospital|Suvival and neurologically intact survival|Hospital discharge|Subset of patients that achieved ROSC and were subsequently admitted to the hospital.|||participants|||Number
2759878|NCT00808236|Secondary|24-hour Adverse Events (AE)|These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.|24 hours after arrest|all enrolled participants|||all participants|||Number
2759879|NCT00808236|Secondary|Serious Adverse Events (SAEs)|These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.|7 days after arrest|"All enrolled patients; see additional modified at risk population based on study attrition in the Adverse Event section."|||all participants|||Number
2759880|NCT00808236|Post-Hoc|Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse|ROSC, Survival, and neurologically-intact survival|Hospital discharge|Subset of patients receiving EMS CPR within 10 minutes of collapse (representing 75% of all patients)|||participants|||Number
2759881|NCT00808236|Secondary|Length of Stay|"Length of stay data for patients admitted to the hospital will be calculated for:~Days on ventilator~Days in intensive care without ventilator~Days in general ward"|Hospital Discharge|Evaluable patients admitted to the hospital|||days||Inter-Quartile Range|Median
2759882|NCT00808236|Secondary|Time to Therapeutic Temperature|The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.|within 8 hours after enrollment|The subset of patients that were resuscitated and subsequently received in-hospital cooling and reached the designated therapuetic temperatures.|||minutes||Inter-Quartile Range|Median
2759883|NCT00808236|Secondary|Primary Outcomes in Sub-group With VF/VT as First Rhythm|ROSC, survival, and neurologically-intact survival|hospital discharge|Subset of all included patients with VF/VT as the first cardiac rhythm present upon ECG assessment by EMS personnel|||participants|||Number
2759884|NCT00808236|Primary|Survived Neurologically-Intact|"The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered neurologically intact.~- Good cerebral performance: little to no deficit.~- Moderate cerebral disability: capable of independent activities of daily life~- Severe cerebral disability: conscious, but dependent on others for daily support~- Coma or vegetative state~- Death or brain death"|30-days after arrest|The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn.|||participants|||Number
2759885|NCT00808236|Primary|Survived to Hospital Discharge|The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.|30 days after arrest|"The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. One RhinoChill patient that achieved ROSC was found to be DNAR upon hospital arrival and was excluded from analyses thereafter. The final number of analyzed RhinoChill patients was therefore 82."|||participants|||Number
2759886|NCT00808236|Primary|Achieve Return of Spontaneous Circulation (ROSC)|ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.|1-hour after arrest|Only patients meeting all inclusion/exclusion criteria (IC/EC) were included in the analyses. 15 patients were found to not meet all IC/EC after enrollment. 2 more patients were lost to follow-up and 1 patient was crossed over (Control to RhinoChill) and then withdrawn. Informed consent nor data was obtained for any of these patients.|||participants|||Number
2759887|NCT00808132|Secondary|Percentage of Participants With Uterine Bleeding|Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.|Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm respectively.|||Percentage of Participants|||Number
2759888|NCT00808132|Secondary|Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline, Month 3|"MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N: maximum number of participants who were evaluable for this outcome and n: participants who were evaluable at specified time points for each arm."|||Units on a Scale||Standard Error|Least Squares Mean
2759889|NCT00808132|Secondary|Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.|||Units on a Scale||Standard Deviation|Mean
2759890|NCT00808132|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline, Month 3|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.|||Units on a Scale||Standard Error|Least Squares Mean
2759891|NCT00808132|Other Pre-specified|Percentage of Participants With Breast Tenderness|Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.|Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.|||Percentage of Participants|||Number
2759892|NCT00808132|Secondary|Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.|||Units on a Scale||Standard Deviation|Mean
2759904|NCT00808067|Secondary|Annualized Rate of Subjects With Minor Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759893|NCT00808132|Secondary|Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study|Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.|Baseline, Month 6, 12|"MITT for osteoporosis substudy. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm respectively."|||Percent Change||Inter-Quartile Range|Median
2759894|NCT00808132|Secondary|Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study|Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study|Baseline, Month 12|"Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here N signifies participants who were evaluable for this outcome measure."|||Percent Change||Standard Error|Least Squares Mean
2759895|NCT00808132|Secondary|Percentage of Participants With Cumulative Amenorrhea: Main Study|Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.|Day 1 up to Day 364|MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2759896|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study|BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6, Month 12|"MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here n signifies participants who were evaluable at specified time points for each arm, respectively."|||Percent Change||Standard Error|Least Squares Mean
2759897|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6|"MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here N signifies participants who were evaluable for this outcome measure."|||Percent Change||Standard Error|Least Squares Mean
2759898|NCT00808132|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 12|Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.|||Percent Change||Standard Error|Least Squares Mean
2759899|NCT00808132|Primary|Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.|Month 12|Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
2759900|NCT00808080|Secondary|If Phase I Has Successfully Shown the Target Dose to be Below the MTD Continue Enrolling Until 38 Patients Have Received the Target Dose. Patients Will be Monitored for Safety and Efficacy.|6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. No CTL infusions were administered to any subject, consequently NO outcome measure results are available.|2.5 years estimated|None. 6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. No CTL infusions were administered to any subject, consequently NO outcome measure results are available.||||||
2759901|NCT00808080|Primary|6 Dose Cohorts for Safety Monitoring. Each Cohort is Assessed for DLT for One Month After Autologous Cultured CTL Infusion Prior to Enrolling the Next Cohort.||2.5 years estimated|Not Applicable as none of the enrolled patients became eligible for infusion||||||
2759902|NCT00808067|Secondary|Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759903|NCT00808067|Secondary|Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759905|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759906|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759907|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759908|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759909|NCT00808067|Secondary|Death, Annualized Rate of Subject Death|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759910|NCT00808067|Secondary|Deep Vein Thrombosis, Annualized Rate of Subjects With DVT|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deep Vein Thrombosis (DVT) was generally documented by one of the following:~abnormal compression ultrasound (CUS),~an intraluminal filling defect on venography."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759911|NCT00808067|Secondary|Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759912|NCT00808067|Secondary|Pulmonary Embolism (PE), Annualized Rate of Subjects With PE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Pulmonary Embolism was generally documented by one of the following:~an intraluminal filling defect in segmental or more proximal branches on spiral CT scan~an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram~a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)~inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759913|NCT00808067|Secondary|Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759914|NCT00808067|Secondary|Stroke, Annualized Rate of Subjects With Stroke|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital"|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759915|NCT00808067|Primary|Major Bleeding, Annualized Rate of Subjects With Major Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Major bleeding must have satisfied one or more of the following criteria:~Bleeding associated with a reduction in hemoglobin of at least 20 g/L~Required transfusion of at least 2 units of blood or packed cells~Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal~Major bleed were classified as life-threatening if they met one or more of the following criteria:~Reduction in hemoglobin of at least 50 g/L~Transfusion of at least 4 units of blood or packed cells~Symptomatic intracranial bleeding, either subdural or intracerebral~Associated with hypotension requiring use of intravenous inotropic agents~Required surgical intervention to stop bleeding~Resulted in death"|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
2759916|NCT00808028|Other Pre-specified|Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B||Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Titer||95% Confidence Interval|Geometric Mean
2759917|NCT00808028|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level||1 month before vaccination 1, 1 month after vaccination 2, 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Percentage of participants|||Number
2759918|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 2||6 month after vaccination 3 up to 48 months|Safety population included participants who received at least 1 dose of study vaccine.|||Percentage of participants|||Number
2759919|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 1||Vaccination 1 upto 1 Month after vaccination 3|Safety population included participants who received at least 1 dose of study vaccine.|||Percentage of participants|||Number
2759920|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3||Before vaccination 1 up to 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Percentage of participants|||Number
2759921|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2||Before vaccination 1 up to 1 month after vaccination 2|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Percentage of participants|||Number
2759922|NCT00808015|Other Pre-specified|Concomitant Drug Treatments||Baseline through Last observed study visit (Week 12 or ET)|FAS included all participants who received at least 1 dose of study medication.|||Participants|||Number
2759923|NCT00808015|Other Pre-specified|Median Duration of Treatment of Varenicline|The duration was defined as the total number of dosing days from first to last day of each study treatment.|Baseline through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis.|||Days||Full Range|Median
2759924|NCT00808015|Other Pre-specified|Average Daily Dose of Varenicline||Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||mg||Full Range|Median
2759925|NCT00808015|Other Pre-specified|Varenicline Prescription Status|Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'.|After last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication.|||participants|||Number
2759926|NCT00808015|Secondary|Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit|The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=518).|||cigarettes||Full Range|Median
2759927|NCT00808015|Secondary|CO Level at Last Observed Study Visit|The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=115).|||ppm||Standard Deviation|Mean
2759928|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 3 through Week 11|At Week t (t = 3 to 11), the analysis population was “Observed Cases minus Week t” (OC minus Week t), that is (i-e), participants in FAS excluding missing values at the time point in question where OC was the subset of participants in FAS with observed (not missing) values.|||percentage of participants|||Number
2759929|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Last observed study visit (Week 12 or early termination [ET])|FAS included all participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2759977|NCT00807742|Primary|Average Number of Cigarettes Per Day|Timeline Followback interview assessing number of cigarettes on each day of each 3-month reporting period|6-month follow up|Outcome data available for 268 participants who completed 6 month follow up. 5 participants died and 67 were lost to follow up before 6 month follow up.|||cigarettes||Standard Deviation|Mean
2759930|NCT00808015|Primary|Percentage of Participants With Smoking Abstinence at Week 12|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication|||percentage of participants||95% Confidence Interval|Number
2759931|NCT00807989|Secondary|Seizure Free Rate for 52 Weeks at Initial Target Dose||52 weeks||||participants|||Number
2759932|NCT00807989|Secondary|Seizure Free Rate for 24 Weeks at Initial Target Dose||24 weeks||||participants|||Number
2759933|NCT00807989|Primary|Retention Rate After 52 Weeks Maintenance Period|* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.|52 weeks||||participants|||Number
2759934|NCT00807937|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 4 minus percentage at randomization"|Baseline to week 4||||percentage||Standard Error|Least Squares Mean
2759935|NCT00807937|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
2759936|NCT00807937|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|"The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.~Change: score at week 4 minus score at randomization"|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
2759937|NCT00807937|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
2759938|NCT00807937|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
2759939|NCT00807885|Secondary|Time Required to Infuse 1000 mL Fluid||from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused|ITT (all treated subjects)|||hours||Standard Deviation|Mean
2759940|NCT00807885|Secondary|Time Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)|||seconds||Full Range|Median
2759941|NCT00807885|Secondary|Attempts Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)|||participants|||Number
2759942|NCT00807885|Primary|Technical Challenges|Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered|throughout subcutaneous hylenex and fluid administration period (continuous)|ITT (all treated subjects)|||participants|||Number
2759943|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).|||bpm||Standard Deviation|Mean
2759944|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).|||mmHg||Standard Deviation|Mean
2759945|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.|||bpm (beats per minute)||Standard Deviation|Mean
2759946|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.|||mmHg||Standard Deviation|Mean
2759947|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.|Week 6/Final Visit|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.|||Participants|||Number
2759948|NCT00807846|Secondary|Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.|6 weeks|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.|||mm||Standard Error|Least Squares Mean
2759949|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.|Week 6/Final Visit|The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.|||Participants|||Number
2759950|NCT00807846|Secondary|Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.|6 weeks|Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.|||mm (millimeter)||Standard Error|Least Squares Mean
2759951|NCT00807846|Secondary|Change From Baseline in DBP at Week 6/Final Visit|Value at 6 weeks/Final Visit minus value at baseline.|6 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
2759952|NCT00807846|Secondary|Change From Baseline in DBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
2759953|NCT00807846|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
2759954|NCT00807846|Secondary|Change From Baseline in SBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
2759955|NCT00807846|Secondary|Change From Baseline to Week 2 in SBP.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
2759956|NCT00807846|Primary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit|Value at 6 weeks minus value at baseline.|6 Weeks/Final Visit|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP (blood pressure) measurements.~For early terminations the last observation carried forward (LOCF) was used to impute missing data."|||mmHg (millimeter of mercury)||Standard Error|Least Squares Mean
2759957|NCT00807768|Other Pre-specified|Gene Expression Based Risk Score||Baseline|||||||
2759958|NCT00807768|Secondary|Patient-reported Quality of Life|Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL|Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment|Provided baseline and >= follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
2759959|NCT00807768|Secondary|Patient-reported Neurotoxicity|Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less neurotoxicity.|Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.|Provided baseline and ≥ follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
2759960|NCT00807768|Secondary|Patient Reported Fatigue|Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue.|Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment|Provided baseline and >= follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
2759961|NCT00807768|Secondary|Number of Participants With Sites of Recurrence|Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event.|Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years|All enrolled patients|||Participants|||Count of Participants
2759962|NCT00807768|Secondary|Number of Participants With Death Events|The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.|Overall survival is measured from study enrollment for up to 10 years.|All enrolled patients.|||Participants|||Count of Participants
2759963|NCT00807768|Primary|Number of Participants With Recurrence or Death Events at Primary Analysis|Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact|Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years|All enrolled patients|||Participants|||Count of Participants
2759964|NCT00807742|Primary|Percent Smoking Days||12-month follow up|Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.|||percentage of days||Standard Deviation|Mean
2759965|NCT00807742|Primary|Percent Smoking Days||6-month follow up|Outcome data available for 268 participants who completed 6 month follow up. 5 participants died and 67 were lost to follow up before 6 month follow up.|||percentage of days||Standard Deviation|Mean
2759966|NCT00807742|Primary|Percent Smoking Days||3-month follow up|Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.|||percentage of days||Standard Deviation|Mean
2759967|NCT00807742|Primary|Percent Smoking Days||1-month follow up||||percentage of days||Standard Deviation|Mean
2759968|NCT00807742|Primary|Number of Participants With Relapse to Any Drug Use||12-month follow up|Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.|||participants|||Number
2759969|NCT00807742|Primary|Number of Participants With Relapse to Any Drug Use||6-month follow up|Outcome data available for 268 participants who completed 6 month follow up. 5 participants died and 67 were lost to follow up before 6 month follow up.|||participants|||Number
2759970|NCT00807742|Primary|Number of Participants With Relapse to Any Drug Use||3-month follow up|Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.|||participants|||Number
2759971|NCT00807742|Primary|Number of Participants With Relapse to Any Drug Use||1-month follow up||||participants|||Number
2759972|NCT00807742|Primary|Number of Participants With Relapse to Any Heavy Drinking|Heavy drinking = 6 or more drinks for men; 5 or more drinks for women|12-month follow up|Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.|||participants|||Number
2759973|NCT00807742|Primary|Number of Participants With Relapse to Any Heavy Drinking|Heavy drinking = 6 or more drinks for men; 5 or more drinks for women|6-month follow up|Outcome data available for 268 participants who completed 3 month follow up. 5 participants died and 67 were lost to follow up before 3 month follow up.|||participants|||Number
2759974|NCT00807742|Primary|Number of Participants With Relapse to Any Heavy Drinking|Heavy drinking = 6 or more drinks for men; 5 or more drinks for women|3-month follow up|Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.|||participants|||Number
2759975|NCT00807742|Primary|Number of Participants With Relapse to Any Heavy Drinking|Heavy drinking = 6 or more drinks for men; 5 or more drinks for women|1-month follow up||||participants|||Number
2759976|NCT00807742|Primary|Average Number of Cigarettes Per Day||12-month follow up|Outcome data available for 240 participants who completed 12 month follow up. 11 participants died and 89 were lost to follow up before 12 month follow up.|||cigarettes||Standard Deviation|Mean
2759978|NCT00807742|Primary|Average Number of Cigarettes Per Day||3-month follow up|Outcome data available for 291 participants who completed 3 month follow up. 3 participants died and 46 were lost to follow up before 3 month follow up.|||cigarettes||Standard Deviation|Mean
2759980|NCT00807742|Primary|Number of Participants Smoking Abstinent in Past 7 Days|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|12-month follow up|"Intent to Treat Note: People who were lost were counted as smoked. 11 participants died before 12 month follow up were coded as missing."|||participants|||Number
2759981|NCT00807742|Primary|Number of Participants Smoking Abstinent in Past 7 Days|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|6-month follow up|"Intent to Treat Note: People who were lost were counted as smoked. 5 participants died before 6 month follow up were coded as missing."|||participants|||Number
2759982|NCT00807742|Primary|Number of Participants Smoking Abstinent in Past 7 Days|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|3-month follow up|"Intent to Treat Note: People who were lost were counted as smoked. 3 participants died before 3 month follow up were coded as missing."|||participants|||Number
2759983|NCT00807742|Primary|Number of Participants Smoking Abstinent in Past 7 Days|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|1-month follow-up|"Intent to Treat Note: People who were lost were counted as smoked."|||participants|||Number
2759984|NCT00807664|Secondary|Total Number of Adverse Events||Day 0 to Day 70||||Adverse Event|||Number
2759985|NCT00807664|Secondary|Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline|"The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation:~Area= Lenght *Width * pi [3.142] / 4~All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used."|Day 0 to Day 70|ITT (ANCOVA) - LOCF was applied for subjects not having a value at visit 3 but a value at visit 2 for the ulcer area|||Percentage change||95% Confidence Interval|Mean
2759986|NCT00807664|Primary|Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline|"The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation:~Area= Lenght *Width * pi [3.142] / 4~All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used."|Day 0 to Day 42|A total of 182 subjects were randomised in the study (safety analysis set), however one patient was in systemic antibiotic treatment and was erroneously enrolled, hence the ITT analysis set comprised 181 subjects.|||Percentage change||Standard Deviation|Mean
2759987|NCT00807599|Secondary|Overall Survival||up to 4 years||||percentage of participants alive||95% Confidence Interval|Number
2759988|NCT00807599|Secondary|Overall Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||Participants|||Count of Participants
2759989|NCT00807599|Secondary|Number of Participants With VGPR + CR Rate|"VGPR/Very Good Partial Response + CR/Complete Response (>/= VGPR) for each study arm~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|2 years||||Participants|||Count of Participants
2759990|NCT00807599|Primary|Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.||2 years||||percentage of participants||95% Confidence Interval|Number
2759991|NCT00807586|Secondary|Repeat Intervention|Need for repeat ablation|3 months|14 patients lost to follow up|||Participants|||Count of Participants
2759992|NCT00807586|Secondary|Symptoms Post Ablation Requiring Diuretic|Occurrence of shortness of breath or edema requiring administration of a diuretic|6 weeks|Data were not collected on this outcome||||||
2759993|NCT00807586|Secondary|Cardiac Pain Assessment|Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)|one day and one week|4 patients lost to follow up|||units on a scale||Standard Deviation|Mean
2759994|NCT00807586|Primary|Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks|Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication|6 weeks|3 patients lost to follow-up|||Participants|||Count of Participants
2759995|NCT00807573|Primary|Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||participants|||Number
2759996|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|up to 44 weeks||||percentile||Standard Deviation|Mean
2759997|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)|up to 44 weeks||||Z-score||Standard Deviation|Mean
2759998|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|baseline||||percentile||Standard Deviation|Mean
2759999|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.|up to 44 weeks||||kg/m^2||Standard Deviation|Mean
2760000|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.|baseline||||kg/m^2||Standard Deviation|Mean
2760001|NCT00807560|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI z score.|up to 44 weeks||||pounds||Standard Deviation|Mean
2760002|NCT00807560|Secondary|Weight|This variable informs the calculation for the outcome variable of BMI Z score.|baseline||||pounds||Standard Deviation|Mean
2760011|NCT00807495|Secondary|Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events|Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 25 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
2760012|NCT00807495|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events|Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 25 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
2760013|NCT00807495|Secondary|Number of Participants With Treatment-Emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator).|First dose of study drug to 30 days after last dose (Up to 25 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
2760014|NCT00807495|Secondary|Duration of Response (DOR)|DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007).|Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)|Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. All responders were evaluated in this outcome measure. Participants who had not progressed, DOR was censored at last response assessment that was SD or better.|||days||95% Confidence Interval|Median
2760015|NCT00807495|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death.|Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)|Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. For a participant who had not progressed and had not died, PFS was censored at the last response assessment that was SD or better.|||days||95% Confidence Interval|Median
2760016|NCT00807495|Secondary|Time to Progression (TTP)|Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)|Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. Here number of participants analyzed were participants with PD. TTP was censored at the last response assessment that was SD or better.|||days||95% Confidence Interval|Median
2760017|NCT00807495|Primary|Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria)|Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).|Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)|Safety population was defined as all participants who received any amount of alisertib. Efficacy analysis for the response-evaluable population is a subset of the safety population, with participants having a minimum of baseline imaging and one on-study imaging.|||percentage of participants|||Number
2760018|NCT00807456|Primary|Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement|Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant (the rim (R), i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.|At baseline and 16 weeks||||millimeter|Participants|Standard Deviation|Mean
2760019|NCT00807365|Primary|Change in Lean Body Mas||2 years|Study terminated prior to collection of data||||||
2760020|NCT00807248|Secondary|Clinical Global Impression - Global Improvement (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|at Week 8|At Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760021|NCT00807248|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760022|NCT00807248|Secondary|SDS: Social Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760023|NCT00807248|Secondary|SDS: Work Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760024|NCT00807248|Secondary|Sheehan Disability Scale (SDS): Family Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760025|NCT00807248|Secondary|Insomnia Severity Index (ISI)|The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760026|NCT00807248|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
2760027|NCT00807248|Secondary|MADRS|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|From baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Least Squares Mean
2760028|NCT00807248|Primary|Montgomery and Åsberg Depression Rating Scale (MADRS)|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|Baseline to 8 weeks|Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)|||Scores on a scale||Standard Error|Mean
2760029|NCT00807235|Secondary|Number of Participants With Air Leak||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760030|NCT00807235|Secondary|Incidence of Mortality||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760031|NCT00807235|Secondary|Number of Participants With Acquired Sepsis||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760032|NCT00807235|Secondary|Number of Participants With Pulmonary Hemorrhage||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760033|NCT00807235|Secondary|Number of Participants With Necrotizing Enterocolitis (NEC)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760034|NCT00807235|Secondary|Number of Participants With Patent Ductus Arteriosus (PDA)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760035|NCT00807235|Secondary|Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760036|NCT00807235|Secondary|Number of Participants Alive and Without BPD||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760037|NCT00807235|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760038|NCT00807235|Secondary|Time to Meet Failure Criteria|Failure criteria defined as rescue with bolus surfactant and mechanical ventilation|Through 28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat). Time in days calculated for neonates who met failure criteria (3 for Regimen 1, 2 for Regimen 2)"|||days||Standard Deviation|Mean
2760051|NCT00807092|Secondary|Change in Mean FBG Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 0, week 6||||mmol/L||Standard Error|Least Squares Mean
2761516|NCT00795951|Primary|Diagnostic Performance: Mercaptobenzothiazole|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2760039|NCT00807235|Secondary|Arterial Alveolar (a/A) O₂Ratio|a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.|72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||mm Hg over mm Hg (ratio of pressures)||Standard Deviation|Mean
2760040|NCT00807235|Secondary|Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||percent O₂*hours||Standard Deviation|Mean
2760041|NCT00807235|Primary|Number of Participants With Respiratory Distress Syndrome||24 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
2760042|NCT00807209|Primary|Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.|The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.|72 hours||||micrograms|||Number
2760043|NCT00807092|Secondary|Hypoglycaemia Based on Self-reported Episodes|Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified as major, minor or symptoms only: Major if the subject was unable to treat her/himself; minor if subject was able to treat her/himself and self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.|Weeks 0-6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).|||episodes|||Number
2760044|NCT00807092|Secondary|Duration of Hypoglycaemic Events Based on CGMS|The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).|72-hour monitoring period at Week 0 and Week 6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).|||Hours||Standard Error|Least Squares Mean
2760045|NCT00807092|Secondary|Change in Glycosylated Haemoglobin (HbA1c)||Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||percentage point change||Standard Error|Least Squares Mean
2760046|NCT00807092|Secondary|Change in GA (Glycated Albumin)|Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.|Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||percentage point change||Standard Error|Least Squares Mean
2760047|NCT00807092|Secondary|Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS|MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
2760048|NCT00807092|Secondary|Change in Prandial Blood Glucose Increment|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
2760049|NCT00807092|Secondary|Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products|||mmol/L||Standard Error|Least Squares Mean
2760050|NCT00807092|Secondary|Change in FPG (Fasting Plasma Glucose)|FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
2760052|NCT00807092|Secondary|Mean FBG (Fasting Blood Glucose) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
2760053|NCT00807092|Secondary|Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
2760054|NCT00807092|Primary|Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals|The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period|Week 0, week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
2760055|NCT00807040|Secondary|All-cause Mortality||Measured at Month 24||||Participants|||Count of Participants
2760056|NCT00807040|Primary|Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)||Measured at Month 12||||ml per square meter of body-surface area||Standard Deviation|Mean
2760057|NCT00807014|Secondary|Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination|Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent.|Week 12 or Early Termination|ITT Population. Some participants had no data available and were thus excluded from analysis.|||participants|||Number
2760058|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning|Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).|||scores on a scale||Standard Deviation|Mean
2760059|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness|Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).|||scores on a scale||Standard Deviation|Mean
2760060|NCT00807014|Secondary|Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System|The acne grade on the participant's face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.|||scores on a scale||Standard Deviation|Mean
2760061|NCT00807014|Secondary|Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2760062|NCT00807014|Secondary|Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2760063|NCT00807014|Secondary|Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2|Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman's correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation.|Baseline (Week 0) and Week 2|ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis.|||Correlation coefficient|||Number
2760219|NCT00805870|Primary|Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge|The required amount of force applied to the quadriceps to elicit pain or discomfort.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.|||lbs||Standard Deviation|Mean
2760064|NCT00807014|Secondary|Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value * 100.|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Some participants had no baseline lesions of an individual type; percent change from baseline is undefined for these participants. All participants, however, had at least one type of lesion; thus, all participants in the ITT Population were analyzed for total lesion count.|||percent change in lesions||Standard Deviation|Mean
2760065|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0).|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.|||lesions||Standard Deviation|Mean
2760066|NCT00807014|Secondary|Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). One participant in the Differin arm had no QoL data available and was thus excluded from analysis.|||scores on a scale||Standard Deviation|Mean
2760067|NCT00807014|Primary|Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 2|Intent-to-Treat (ITT) Population: all randomized participants (par.) who applied >= 1 dose of study product. Missing values were imputed using the last observation carried forward (LOCF, i.e., the last available observation was used to estimate subsequent missing data points) method. 1 par. in the Differin arm had no QoL data and was not analyzed.|||scores on a scale||Standard Deviation|Mean
2760068|NCT00807001|Secondary|Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)|Measures how much virus is in the blood.|Baseline to 4 days|efficacy evaluable population = a) must have received all 3 doses of study drug b) must have baseline and at least one post-baseline HCV RNA determination|||log10 IU/mL||Standard Deviation|Mean
2760069|NCT00807001|Primary|Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events|Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening|17 days|Safety population consisted of all subjects who received at least one dose of study drug.|||participants|||Number
2760070|NCT00806988|Secondary|Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention||Measured at Month 24||||Participants|||Count of Participants
2760071|NCT00806988|Primary|Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)||Measured at Month 12||||ml per square meter||Standard Deviation|Mean
2760072|NCT00806819|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 36 months|Treated set uncut - all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.|||% of participants|||Number
2760073|NCT00806819|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2760220|NCT00805870|Primary|Quadriceps Muscle Strength|Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.|||lbs||Standard Deviation|Mean
2760074|NCT00806819|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760075|NCT00806819|Secondary|Clinical Improvement.|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760076|NCT00806819|Secondary|Change From Baseline in Tumour Size|Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||percentage of change in tumor size in mm||95% Confidence Interval|Mean
2760077|NCT00806819|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760078|NCT00806819|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||% of participants|||Number
2760079|NCT00806819|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760080|NCT00806819|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760081|NCT00806819|Secondary|Objective Tumor Response|Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator|From randomisation until data cut-off (15 February 2013), Up to 30 months|Randomised Set|||% of participants|||Number
2760082|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760083|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
2760084|NCT00806819|Secondary|Overall Survival (Key Secondary Endpoint)|Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||months||Inter-Quartile Range|Median
2760085|NCT00806819|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 9 July 2012|RS|||months||Inter-Quartile Range|Median
2760086|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7||||percentage of participants||95% Confidence Interval|Number
2760087|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
2760088|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
2760089|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
2760090|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
2760091|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2|The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively.|Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
2760092|NCT00806624|Secondary|Evaluation of All Clinical and Laboratory Safety Data.||6 months|||||||
2760093|NCT00806624|Secondary|Evaluation of Effects on Pharmacodynamic Biomarkers||6 months|||||||
2760094|NCT00806624|Secondary|Evaluation of Plasma Concentration of DU-176||6 months|||||||
2760095|NCT00806624|Secondary|Evaluation of Effects on Biomarkers of Thrombus Formation||6 months|||||||
2760096|NCT00806624|Secondary|Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition||6 months|||||||
2760097|NCT00806624|Primary|Incidence of All Bleeding|Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.|6 months|The Safety Analysis Set was defined as all subjects who received at least one dose of study drug and had at least one post-dose safety assessment. The primary endpoint were analyzed for the subjects who proceeded to the treatment period in the Safety Analysis Set.|||percentage of subjects with bleeds||95% Confidence Interval|Number
2760098|NCT00806598|Primary|Overall Response|Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.|Of the 48 participants who received treatment 46 were evaluable for response.|||participants|||Number
2760099|NCT00806585|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and did not lack of any endpoint data (both baseline and post-randomization)|||Percentage Change||Standard Error|Least Squares Mean
2760100|NCT00806585|Secondary|Change From Baseline in Body Weight at Week 24|Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||kg||Standard Error|Least Squares Mean
2760101|NCT00806585|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||Percentage Change||Standard Error|Least Squares Mean
2760102|NCT00806585|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||mmHg||Standard Error|Least Squares Mean
2760233|NCT00805740|Secondary|Percentage of Participants With All-cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.|Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2760103|NCT00806585|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||mmHg||Standard Error|Least Squares Mean
2760104|NCT00806546|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch application|Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population.|||scores on a scale|Participants|Standard Deviation|Mean
2760105|NCT00806494|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.|Baseline, Week 12|FAS. n=number of participants with analyzable data.|||Score on Scale||95% Confidence Interval|Mean
2760106|NCT00806494|Secondary|Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12|TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.|Week 12 (or Early Withdrawal)|FAS. N=number of participants with analyzable data.|||Percentage of Participants|||Number
2760107|NCT00806494|Secondary|Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire|BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).|Week 12 (or Early Withdrawal)|FAS, LOCF.|||Participants|||Number
2760108|NCT00806494|Secondary|Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12|ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.|Baseline, Week 12|FAS. N=number of participants with analyzable data.|||Score on Scale||95% Confidence Interval|Mean
2760109|NCT00806494|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12|OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.|Baseline, Week 4 and Week 12|FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.|||Score on Scale||95% Confidence Interval|Mean
2760110|NCT00806494|Secondary|Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12|UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Participants|||Number
2760111|NCT00806494|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12|PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Participants|||Number
2760112|NCT00806494|Secondary|Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12|The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Incontinence Pads||95% Confidence Interval|Mean
2760113|NCT00806494|Secondary|Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
2760114|NCT00806494|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12|SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
2760115|NCT00806494|Secondary|Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
2760116|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12|"NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).~Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
2760117|NCT00806494|Secondary|Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with urgency episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
2760118|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12|Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with urgency episodes >=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
2760119|NCT00806494|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
2760120|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12|"UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).~Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
2760121|NCT00806494|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
2760412|NCT00804648|Primary|Stinging on Instillation|Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
2760122|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of episodes||95% Confidence Interval|Mean
2760123|NCT00806494|Secondary|Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
2760124|NCT00806494|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 4|FAS. N=number of participants with analyzable data.|||Number of Episodes||95% Confidence Interval|Mean
2760125|NCT00806494|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 12|Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.|||Number of Episodes||95% Confidence Interval|Mean
2760126|NCT00806442|Secondary|Urinary Leukotriene Levels|Urinary leukotriene levels in plant seed oil vs. placebo|6 weeks|one participant was missing some urinary leukotriene data|||ng/ml||95% Confidence Interval|Mean
2760127|NCT00806442|Secondary|Night-time Wakenings|Average number of night-time wakenings in plant seed oil vs. placebo|6 weeks|one participant is missing some night-time wakening data|||average number of night-time wakenings||95% Confidence Interval|Mean
2760128|NCT00806442|Secondary|Day-time Symptoms of Bronchial Asthma|"Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms~= Mild: Symptom did not interfere with normal daily activity or sleep~= Moderate: Symptom was sufficient to interfere with normal daily activity or sleep~= Severe: Symptom was so severe as to prevent normal daily activity or sleep~These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus.~The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures."|6 weeks||||units on a scale||95% Confidence Interval|Mean
2760129|NCT00806442|Secondary|Frequency of Rescue Use of Short Acting Beta-2 Agonists|Average number of puffs of albuterol daily in plant seed oil vs. placebo|6 weeks|one participant is missing some data on this measure|||Avg number of puffs of albuterol daily||95% Confidence Interval|Mean
2760130|NCT00806442|Secondary|Peak Flow Rate (PEFR)|Morning Peak Flow Rate in plant seed oil vs. placebo|6 weeks||||liters/minute||95% Confidence Interval|Mean
2760131|NCT00806442|Secondary|Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes|Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm|6 weeks on each treatment assignment|Patients who are C allele carriers or A homozygotes|||Participants|||Count of Participants
2760132|NCT00806442|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo|6 weeks|Includes participants that completed the study.|||liters||95% Confidence Interval|Mean
2760133|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).||||ng/mL||Standard Deviation|Least Squares Mean
2760134|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|"Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.~Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose."|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).|Twenty-eight (28) subjects (excluding 2 that were enrolled but did not complete both study periods) were included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Least Squares Mean
2760413|NCT00804609|Primary|Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)|The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.|a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2760135|NCT00806416|Primary|Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet|Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.|On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).|Two hundred-seven (207) subjects (excluding 7 that were enrolled but did not complete both study periods) were included in the statistical analysis.|||micrograms (μg)||Standard Deviation|Least Squares Mean
2760136|NCT00806403|Secondary|Stroke||30 days|Analysis made on intention to treat (ITT) basis.|||Participants|||Number
2760137|NCT00806403|Secondary|Reinfarction||30 days|Analysis made on intention to treat (ITT) basis.|||Participants|||Number
2760138|NCT00806403|Primary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3|Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.|5-7 days after inclusion|Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery.|||participants|||Number
2760139|NCT00806403|Secondary|Death||30 days|Analysis was made on intention to treat (ITT) basis.|||participants|||Number
2760140|NCT00806403|Primary|Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%|ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion|120 minutes after inclusion|Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis.|||participants|||Number
2760141|NCT00806390|Primary|Ejection Fraction by MUGA|Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.|Pre and post anthracycline treatment|This study was unable to enroll a sufficient number of patients to permit analysis (only 15 patients enrolled)||||||
2760142|NCT00806351|Secondary|All-Cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up|Baseline up to 6 weeks post treatment|Safety Population|||participants|||Number
2760143|NCT00806351|Secondary|Time to Death|Time to death defined as: date of death minus first treatment date plus 1.|Day 1 up to Day 98|Safety Population;subset of participants who died|||days||Full Range|Median
2760144|NCT00806351|Secondary|Time to First Negative Blood Culture for Candida Species|A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.|Baseline up to Day 56|MITT Population; subset of participants who had a positive blood culture for Candida sp. on Day 1 of treatment. No participant in the Caspofungin treatment arm had a positive blood culture for Candida sp. on Day 1 of treatment.|||days||Full Range|Median
2760145|NCT00806351|Secondary|Number of Participants With New Infections|Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.|2 and 6 weeks post treatment|MITT Population|||participants|||Number
2760146|NCT00806351|Secondary|Number of Participants With Recurrence|Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.|2 and 6 weeks post treatment|MITT Population|||participants|||Number
2760147|NCT00806351|Secondary|Clinical Response at Day 10|Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.|Day 10|MITT Population; Number of participants analyzed (N): participants with evaluable data|||participants|||Number
2760148|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|6 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point|||participants|||Number
2760149|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|2 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point|||participants|||Number
2760150|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 14 up to Day 56|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits.|||participants|||Number
2760151|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOIVT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 10 up to Day 42|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits.|||participants|||Number
2760152|NCT00806351|Secondary|Global Response at 6-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|6 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.|||participants|||Number
2760153|NCT00806351|Secondary|Global Response at 2-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|2 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.|||participants|||Number
2760154|NCT00806351|Secondary|Global Response at End of Treatment (EOT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 14 up to Day 56|MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits.|||participants|||Number
2760155|NCT00806351|Primary|Global Response at End of Intravenous Treatment (EOIVT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms [s/s] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up [f/u] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to [≥3] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species [sp]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 10 up to Day 42|Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits.|||participants|||Number
2760156|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:~(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.~The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|Hour 2 and Hour 6|Intent-to-treat (ITT) ITT population includes participants who completed Periods 1, 2 and 3. Subjects that were discontinued due to adverse events, failed drug/alcohol screens, non-compliance, etc. are not included in this analysis.|||scores on a scale||Standard Error|Least Squares Mean
2760481|NCT00803738|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Cure|The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.|Visit 3: Day 22-31|Per Protocol (PP) population|||participants|||Number
2760157|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:~(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.~The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|at breath alcohol levels 0.10%, 0.07%, and 0.04%|modified-intent-to-treat (mITT)|||scores on a scale||Standard Error|Least Squares Mean
2760158|NCT00806234|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol Level||From Baseline to Week 24||||mg/dL||Standard Error|Least Squares Mean
2760159|NCT00806234|Secondary|Triglyceride Levels||Change from baseline to 24 weeks||||mg/dL||Standard Error|Least Squares Mean
2760160|NCT00806234|Secondary|Change in Whole Body Insulin Sensitivity Index||Change from baseline to 24 weeks||||mU/L||Standard Error|Least Squares Mean
2760161|NCT00806234|Primary|Body Mass Index (BMI) Z-score Change||Change from baseline to 24 weeks||||Z Score||Standard Error|Least Squares Mean
2760162|NCT00806221|Secondary|Development of Eczema||1 and 2 year time points||||Participants|||Count of Participants
2760163|NCT00806221|Primary|Compliance With Protocol||over two years||||participants|||Number
2760164|NCT00806221|Primary|Incidence of Skin Infection||1 and 2 year timepoints||||Participants|||Count of Participants
2760165|NCT00806221|Primary|Incidence of Skin Irritation||1 and 2 year time points||||Participants|||Count of Participants
2760166|NCT00806195|Secondary|Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination|Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.|||Subjects|||Number
2760167|NCT00806195|Secondary|Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination|To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.|15 minutes to Day 7|Analysis was done on as treated safety population.|||percentages of subjects|||Number
2760168|NCT00806195|Secondary|Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period|To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.|||Percentages of subjects|||Number
2760169|NCT00806195|Primary|Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination|"To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."|15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age|Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).|||Percentages of subjects|||Number
2760170|NCT00806078|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)|AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol|||ng-h/ml||Standard Deviation|Mean
2760171|NCT00806078|Primary|Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)|The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent.|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol|||ng·h/mL||Standard Deviation|Mean
2760172|NCT00806078|Primary|Maximum Observed Plasma Concentration (Cmax)|The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol|||ng per mL||Standard Deviation|Mean
2760173|NCT00806026|Secondary|Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12|WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.|||Percentage of impairment||Standard Deviation|Mean
2761517|NCT00795951|Primary|Diagnostic Performance: Quaternium-15|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2760174|NCT00806026|Secondary|Medical Outcomes Study-Short Form 36 (SF-36) at Week 12|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from 0=much worse now to 4=much better now. Higher subscale and summary score reflect better health status."|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2760175|NCT00806026|Secondary|Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12|RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on Scale||Standard Deviation|Mean
2760176|NCT00806026|Secondary|Profile of Mood State (POMS) at Week 12|POMS are participant-rated instrument comprising 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment) and each subscale comprising 5 items, on 'How you feel right now?' (Scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for vigor-activity. A total score is obtained for each scale. The range of total score is 0 - 100, with higher score indicating more mood disturbance.|Week 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to lack of sufficient knowledge as how to analyze mood data inferentially in RLS population.||||||
2760177|NCT00806026|Secondary|Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Participants|||Number
2760178|NCT00806026|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2760179|NCT00806026|Secondary|Clinical Global Impressions-Severity (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2760180|NCT00806026|Secondary|Severity of Augmentation Symptoms at Week 12|ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2760181|NCT00806026|Secondary|Change From Baseline in Limb Pain-VAS at Week 12|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||mm||Standard Error|Least Squares Mean
2760182|NCT00806026|Secondary|Limb Pain-Visual Analog Scale (Limb Pain-VAS)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||mm||Standard Deviation|Mean
2761518|NCT00795951|Primary|Diagnostic Performance: Cl+Me-Isothiazolinone|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2760183|NCT00806026|Secondary|Change From Baseline in RLS-NDI at Week 12|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Error|Least Squares Mean
2760184|NCT00806026|Secondary|RLS-Next Day Impact (RLS-NDI)|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2760185|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a scale||Standard Deviation|Mean
2760186|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||awakenings||Standard Deviation|Mean
2760187|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||hours||Standard Deviation|Mean
2760188|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||minutes||Standard Deviation|Mean
2760189|NCT00806026|Secondary|Change From Baseline in SSQ: Subjective WASO at Week 12|SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||minutes||Standard Error|Least Squares Mean
2760234|NCT00805740|Secondary|Time to Negative Blood Culture|Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|A sub-set of MITT population included only those participants who had a positive blood culture for Candida species at baseline.|||days||Full Range|Median
2760190|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)|SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||minutes||Standard Deviation|Mean
2760191|NCT00806026|Primary|Percentage of Participants With Augmentation|Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Baseline up to Week 52|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Percentage of participants|||Number
2760192|NCT00806026|Primary|Percentage of Participants Responding to Treatment at Week 12|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved."|Week 12|ITT population. Last observation carried forward (LOCF) method was used. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Percentage of participants|||Number
2760193|NCT00806026|Primary|Change From Baseline in the RLS Symptom Severity at Week 12|IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Error|Least Squares Mean
2760194|NCT00806026|Primary|Restless Legs Syndrome (RLS) Symptom Severity|International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
2760195|NCT00805961|Secondary|To Assess the Complete Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months|||||||
2760196|NCT00805961|Secondary|To Assess the Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months||||Months||95% Confidence Interval|Number
2760197|NCT00805961|Secondary|To Assess the Toxicity of This Novel Multimodality Regimen||18 months|Information provided in the AEs section||||||
2760198|NCT00805961|Primary|Progression-free Survival (PFS)||18 months||||Months||95% Confidence Interval|Median
2760199|NCT00805948|Other Pre-specified|Number of Participants With Aneurysm Rupture|Rupture or perforation of the targeted aneurismal sac as detected by angiography, CT scan, or direct observation at surgery or autopsy.|1, 12, 24, 36, 48 and 60 months|Based on all Intent to Treat (ITT) subjects|||participants|||Number
2760200|NCT00805948|Other Pre-specified|Number of Participants With Conversion to Surgery|Conversion from endovascular to open repair required at the time of the original procedure or at the time beyond the initial endovascular procedure (for the same lesion treated during the initial implantation of the Talent Thoracic Stent Graft)|1, 12, 24, 36, 48 and 60 months|Based on all Intent to Treat (ITT) subjects.|||participants|||Number
2760201|NCT00805948|Other Pre-specified|All-Cause Mortality|Number of subjects who died during that interval or who were followed at least until the lower endpoint of the analysis window.|1, 12, 24, 36, 48 and 60 months|Based on all Intent to Treat (ITT) subjects.|||Participants|||Number
2760342|NCT00805194|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
2760202|NCT00805948|Primary|Freedom From Aneurysm-related Mortality at 5 Years|For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.|5 years|All participants were combined for analysis as a single arm, as pre-specified in the protocol. Subjects are censored because their last follow-up has not reached the end of the time interval or because they withdraw, are lost to follow-up or die from a non-aneurysm related cause.|||Percentage of participants||95% Confidence Interval|Number
2760203|NCT00805935|Secondary|Participants With Treatment Emergent Adverse Events|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Week 1 to week12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study|||Participants|||Number
2760204|NCT00805935|Secondary|Number of Live Births Resulting From the In Vitro Fertilization Process|Number of live births resulting from the IVF process|Approximately 10 months|Database was locked prior to most participants giving birth.|||Live births|||Number
2760205|NCT00805935|Secondary|Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration|Blood tests were sent to a central laboratory to obtain progesterone levels.|approximately day 16||||ng/mL||Standard Deviation|Mean
2760206|NCT00805935|Secondary|Human Chorionic Gonadotropin (hCG) Levels at Day 6|Blood tests were sent to a central laboratory to obtain hCG levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||mIU/ml||Standard Deviation|Mean
2760207|NCT00805935|Secondary|Estradiol Levels at Day 6|Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||pg/mL||Standard Deviation|Mean
2760208|NCT00805935|Secondary|Percentage of Participants With Ongoing Pregnancy at Week 9|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 65|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2760209|NCT00805935|Secondary|Percentage of Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 52|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2760210|NCT00805935|Secondary|Percentage of Participants With Biochemical Pregnancy at Approximately Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2760211|NCT00805935|Secondary|Number of Embryos Frozen|The number of embryos that were not transferred but instead were frozen for future use.|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Embryos||Standard Deviation|Mean
2760212|NCT00805935|Secondary|Number of Embryos Transferred at Three Stages of Development Before Implantation|"The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.~Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape."|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Embryos||Standard Deviation|Mean
2760213|NCT00805935|Secondary|Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.|approximately day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of oocytes retrieved|||Number
2760214|NCT00805935|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.|approximately day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Oocytes||Standard Deviation|Mean
2760215|NCT00805935|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|approximately day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Follicles||Standard Deviation|Mean
2760216|NCT00805935|Primary|Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3|A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|weeks 1-3|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Participants|||Number
2760217|NCT00805870|Primary|Interleukin-6 Measured in Blood|Interleukin-6 is an indirect indicator of muscle inflammation.|6 days|Number of subjects that completed the protocol. Analysis was per protocol|||pg/mL||Standard Deviation|Mean
2760218|NCT00805870|Primary|Creatine Kinase Activity Measured in Blood|Creatine kinase activity is an indirect indicator of muscle damage.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.|||IU/L||Standard Deviation|Mean
2760221|NCT00805792|Secondary|Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke|The Trail-making test consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the test: A, in which the targets are all numbers (1,2,3, etc.)and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.).|baseline, 90 days post-stroke||||seconds||Standard Error|Mean
2760222|NCT00805792|Secondary|Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke|The mini-mental state examination (MMSE) is a 30-point questionnaire test that is used to screen for cognitive impairment. The questionnaire samples functions including arithmetic, memory and orientation to time and place. Scores range from 0 to 30. Any score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.|baseline, 90 days post-stroke||||units on a scale||Standard Error|Mean
2760223|NCT00805792|Secondary|Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke|The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.|baseline, 90 days post-stroke||||units on a scale||Standard Error|Mean
2760224|NCT00805792|Secondary|Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 90 days post-stroke||||units on a scale||Standard Error|Mean
2760225|NCT00805792|Primary|Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|90 days post-stroke|Intention-to-treat analysis, all treated participants (n=33). Unobserved because of death (n=3) or loss to follow up (N=2) treated as nonresponse.|||percentage of participants|||Number
2760226|NCT00805766|Secondary|Antibody to TA-650 Determination||Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)||||percentage of participants|||Number
2760227|NCT00805766|Secondary|Serum Concentration of TA-650 at Each Time Point||Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks|Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||μg/mL||Full Range|Median
2760228|NCT00805766|Secondary|CDAI Change at Each Evaluation Time Point in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (every 4 weeks for up to 40 weeks)|One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||units on a scale||Full Range|Median
2760229|NCT00805766|Secondary|CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period|CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (every 4 weeks for up to 40 weeks)|Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||percentage of participants||95% Confidence Interval|Number
2760230|NCT00805766|Secondary|CDAI at Each Evaluation Time Point in the Increased Dose Period|CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (every 4 weeks for up to 40 weeks)|One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||units on a scale||Full Range|Median
2760231|NCT00805766|Primary|Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (Week 0 to Week 8)||||units on a scale||95% Confidence Interval|Median
2760232|NCT00805740|Secondary|Time to Death|Time to death (days) was assessed as date of death minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.|||days||Full Range|Median
2760235|NCT00805740|Secondary|Percentage of Participants With New Infection|New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.|||percentage of participants|||Number
2760236|NCT00805740|Secondary|Percentage of Participants With Relapse|Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.|||percentage of participants|||Number
2760237|NCT00805740|Secondary|Percentage of Participants With Clinical Response|A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.|Day 10|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.|||percentage of participants||95% Confidence Interval|Number
2760238|NCT00805740|Secondary|Percentage of Participants With Response Based on Clinical Cure and Microbiological Success|A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.|EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, ‘n’ signifies those participants who were evaluable for this measure at given time points for each group respectively.|||percentage of participants|||Number
2760239|NCT00805740|Secondary|Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species. Only participants who completed therapy or who had global response of failure at EOT were evaluable for 2- and 6-week follow-up analysis.|||percentage of participants||95% Confidence Interval|Number
2760240|NCT00805740|Primary|Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|End of Treatment (Day 14 to Day 42)|Modified Intent-To-Treat (MITT) population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species (sp.).|||percentage of participants||95% Confidence Interval|Number
2760241|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Half-live of Free Virus|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||Hours||Standard Deviation|Mean
2760242|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t) I(t) (1 ) (T I(t))V(t) I(t) where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise allinfected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||Percentage||Standard Deviation|Mean
2760243|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||day^-1||Standard Deviation|Mean
2760244|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Viral Clearance|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||day^-1||Standard Deviation|Mean
2760245|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Estimated Viral Load|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||log10 copies/ml||Standard Deviation|Mean
2760246|NCT00805675|Secondary|"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"|"HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). HBeAg stands for hepatitis B e antigen. This antigen is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the person is infectious and is able to spread the virus to other people."|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. Note: In this analysis 1 patient HBeAg loss in the Telbivudine 600 mg and Tenofovir 300 mg Treatment Group.|||Percentage of Participants|||Number
2760247|NCT00805675|Secondary|Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12|Polymerase Chain Reaction (PCR) Negative is defined as HBV DNA levels <25 copies/ml.|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. (1 pat DNA<169 cps/ml)|||Percentage of Participants|||Number
2760248|NCT00805675|Secondary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 2, Week 4, Week 8|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||log10 copies/mL||Standard Deviation|Mean
2760249|NCT00805675|Primary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||log10 copies/mL||Standard Deviation|Mean
2760250|NCT00805545|Primary|Endometritis and Wound Infection|In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby.|Patients were followed from the time of surgery until 6 weeks postpartum.|All 194 patients who received preoperative antibiotics and who completed the study were analyzed. All 197 patients who received post-cord clamping antibiotics and who completed the study were analyzed.|||patients infected||95% Confidence Interval|Number
2760251|NCT00805532|Secondary|Behavioral Activation Scale (BAS)|The BAS is a 25-item self-report measure that assesses overall degree of behavioral activation as well as indicators of inactivation across three subscales: avoidance/rumination, work/school impairment, and social impairment. Items are rated on 7-point Likert scales (0=not at all to 6=completely). The total BAS score reflects overall level of activation with high scores reflecting higher activation (range 0 - 150).|Pre-treatment, post-treatment (12 weeks after 1st therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)|OIF/OEF Veterans with PTSD|||units on a scale||Standard Deviation|Mean
2760252|NCT00805532|Secondary|Sheehan Disability Scale (SDS)|The Sheehan Disability Scale (SDS) (Sheehan, 2000) is a three item self-rated scale of impairment that is widely used in psychopharmacology studies (allowing comparison with these studies). The items ask the respondent to rate (on a Likert scale of 0-10, unimpaired to highly impaired) to what extent their symptoms interfere with their functioning in the areas of: work, social, and family life; a summary score can be obtained by summing the three items (range 0-30, unimpaired to highly impaired). The scale's reliability and concurrent validity have been demonstrated in individuals with anxiety disorders and depression.|Pre-treatment, post-treatment (12 weeks after first psychotherapy session), 3-month follow-up (24 weeks after first psychotherapy appointment)|OIF/OEF Veterans with PTSD|||units on a scale||Standard Deviation|Mean
2760272|NCT00805441|Secondary|Change From Baseline in Penn Alcohol Craving Scale (PACS)|PACS is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, ability to resist drinking and craving. Each item ranges from 0-6 with 6 indicating worse symptoms.|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had PACS assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2760253|NCT00805532|Secondary|Beck Depression Inventory-II (BDI-II)|The Beck Depression Inventory-II (BDI-II) (Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on Likert-scales from 0-3 (individual descriptions are provided for each number ranging from the absence of the symptom to the severe manifestation of the symptom). Scores can range from 0-63 with higher scores representing higher levels of depression. This widely used measure of depression is commonly included in outcome studies in order to determine treatment effects on severity of depressive symptoms and has excellent psychometric properties.|Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)|OIF/OEF Veterans with PTSD|||units on a scale||Standard Deviation|Mean
2760254|NCT00805532|Secondary|Posttraumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-M is a 17 item self-report scale that assesses the presence of DSM-IV PTSD symptoms. Items are rated on a 5-point Likert scale (1= not at all to 5=extremely) according to how much the symptom bothered the respondent over the past month. Scores range from 17-85 with higher scores representing greater symptom severity.|Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)|OIF/OEF Veterans with PTSD|||units on a scale||Standard Deviation|Mean
2760255|NCT00805532|Primary|Clinician Administered PTSD Scale (CAPS-IV)|"The CAPS is a clinician-administered scale and is considered the gold standard for assessing the presence of PTSD. Items are ranked on Likert scales according to both frequency (0=never to 4=daily or almost every day) and intensity (0=none to 4=extreme) of symptoms, yielding an overall severity score by summing frequency and intensity ratings (range 0 to 136, with higher scores reflecting greater symptomatology). Scale scores corresponding to the 3 subcategories of PTSD symptoms (intrusive symptoms, avoidance symptoms, and hyperarousal symptoms) can be similarly obtained (scores range from 0-40, 0-56, 0-40 for the 3 subscales, respectively). Internal consistency, interrater reliability, and validity of this measure are strong and well-documented."|Pre-treatment, post-treatment (12 weeks after 1st therapy session), and 3-month follow-up (24 weeks after first therapy session)|OIF/OEF Veterans with PTSD|||units on a scale||Standard Deviation|Mean
2760256|NCT00805493|Primary|Pediatric Anxiety Scale|A standard measure of severity of anxiety over the previous week. The score ranges from a total of 0-25, with 0 being absence of symptoms and impairment, and 25 being marked symptoms and severe impairment. The outcome measure for each participant is the change in PARS, that is, the difference at week 8 compared to baseline (when medication-free).|Weekly for 8 weeks||||units on a scale||Standard Deviation|Mean
2760257|NCT00805493|Primary|Clinical Global Impression--Improvement|This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.|8 week trial with the study running for about 4 years.||||units on a scale||Standard Deviation|Mean
2760258|NCT00805480|Secondary|Percentage of Participants in Each Investigator Global Assessment (IGA) Category|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set participants, who had values at each week category, were included in the analysis. As such, the population at each week varies from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations.|||Percentage of participants|||Number
2760259|NCT00805480|Secondary|Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.|||Percentage of participants|||Number
2760260|NCT00805480|Secondary|Percentage of Participants With at Least 50% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.|||Percentage of participants|||Number
2760261|NCT00805480|Primary|Percentage of Participants Who Had Not Relapsed at Any Time in the Trial|This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.|||Percentage of participants|||Number
2760273|NCT00805441|Secondary|Change From Baseline in Alcohol Urge Questionnaire (AUQ)|AUQ measures participant's feeling and thoughts about drinking, and uses a 7 point (1-7) Likert scale for each of 8 items (questions). Scores range from 8 (less urge to drink) to 56 (more urge to drink).|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had AUQ assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2760262|NCT00805480|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Baseline, Week 12|Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.|||scores on a scale||Standard Deviation|Mean
2760263|NCT00805467|Secondary|HAQ-DI Score|Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.|||Scores on a Scale||Standard Deviation|Mean
2760264|NCT00805467|Secondary|DAS28-CRP Score|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.|||scores on a scale||Standard Deviation|Mean
2760265|NCT00805467|Primary|Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||% of patients|||Number
2760266|NCT00805441|Secondary|12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)|Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The MCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.|Baseline and Week 12|All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.|||units on a scale||Standard Deviation|Mean
2760267|NCT00805441|Secondary|12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)|Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The PCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.|Baseline and Week 12|All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.|||units on a scale||Standard Deviation|Mean
2760268|NCT00805441|Secondary|Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)|Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption.|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had CDT assessed at both baseline and post-baseline.|||percent CDT||Standard Deviation|Mean
2760269|NCT00805441|Secondary|Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)||Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had GGT assessed at both baseline and post-baseline.|||units per liter (U/L)||Standard Deviation|Mean
2760270|NCT00805441|Secondary|Change From Baseline Beck Anxiety Index (BAI) Total Score|BAI is a 21-item participant-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0= not present; 3= present in the extreme). Total scores range from 0 to 63. Higher total scores indicate greater severity of anxiety symptoms.|Baseline, Weeks 6 and 12|All randomized participants who received at least one dose of study drug and had BAI assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2760271|NCT00805441|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score|BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. There is a 4-point scale for each item ranging from 0 (no depression) to 3 (very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression.|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had BDI-II assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2760340|NCT00805194|Secondary|Clinical Improvement|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised set|||months||Inter-Quartile Range|Median
2760274|NCT00805441|Secondary|Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale|DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. All items for the DrInC are scored from 0-3 with higher scores indicating worse adverse consequences. Interpersonal subscale (10 items: scores range from 0-30) measures the impact of drinking on the participants' relationships. Physical subscale (8 items: scores range from 0-24) measures adverse physical states resulting from excessive drinking. Social subscale (7 items: scores range from 0-21) measures role fulfillment. Impulsive subscale (12 items: scores range from 0-36) measures sequelae of over drinking. Intrapersonal subscale (8 items: scores range from 0-24) measures subjective perceptions that may not be readily observable by others. Total scores range from 0-150, with higher scores indicating greater severity of symptoms.|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had DrInC assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2760275|NCT00805441|Secondary|Time to First Heavy Drinking Day|"The Alcohol Timeline Followback (TLFB) is used to assess the time to first heavy drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. Those who did not drink are considered to be censored."|Baseline up to Week 12|All randomized participants who received at least one dose of study drug and had daily drinking assessed. The numbers of participants censored are 4 for LY686017 group and 3 for placebo group.|||days||Standard Deviation|Mean
2760276|NCT00805441|Secondary|Number of Drinks Per Drinking Day During a Month|The Alcohol Timeline Followback (TLFB) is used in calculating the number of drinks per drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv).|Baseline and Weeks 4 and 8 and12 and 16|All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.|||drinks/drinking day/month||Standard Deviation|Mean
2760277|NCT00805441|Secondary|Percent Days Abstinent Per Month|The Alcohol Timeline Followback (TLFB) is used in calculating the percentage of days abstinent (days where no alcoholic drinks were consumed). The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Percentage days per month= (number of days where no alcoholic beverages were consumed/number of days in a month)*100.|Baseline and Weeks 4 and 8 and 12 and 16.|All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.|||percentage days abstinent per month||Standard Deviation|Mean
2760278|NCT00805441|Primary|Percent Change From Baseline in Heavy Drinking Days|The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.|Baseline, Weeks 4 and 8 and 12 and 16|All randomized participants who received at least one dose of study drug and had daily drinking assessed at both baseline and post-baseline.|||percent of heavy drinking days||Standard Deviation|Mean
2760279|NCT00805389|Secondary|Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760280|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760281|NCT00805389|Secondary|Levels of mRNA as Measured by qPCR|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760282|NCT00805389|Secondary|Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760283|NCT00805389|Secondary|mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760284|NCT00805389|Secondary|mRNA Levels as Measured by qPCR|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760285|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
2760286|NCT00805389|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination|A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2760287|NCT00805389|Secondary|Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs)|AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2760288|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.|||Participants|||Count of Participants
2760401|NCT00804648|Secondary|Visual Acuity|The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.|following 3 days of treatment||||number of letters||Standard Deviation|Mean
2760402|NCT00804648|Secondary|Conjunctival Staining - Temporal Count|Assessed by investigator using a slit lamp and counting number of spots.|following 3 days of treatment||||number of spots||Standard Deviation|Mean
2760289|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.|Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
2760290|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination.|Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
2760291|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
2760292|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination.|Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.|||Participants|||Count of Participants
2760293|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.|||Participants|||Count of Participants
2760294|NCT00805389|Secondary|Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.|||Participants|||Count of Participants
2760295|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|post vaccination (up to Day 360).|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
2760403|NCT00804648|Secondary|Conjunctival Staining - Temporal Grade|Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
2760404|NCT00804648|Secondary|Conjunctival Staining - Nasal Count|Assessed by investigator using slit lamp and counting number of spots.|following 3 days of treatment||||number of spots||Standard Deviation|Mean
2760296|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
2760297|NCT00805389|Secondary|Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.|||Participants|||Count of Participants
2760298|NCT00805389|Secondary|Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|Post vaccination (up to Day 360)|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Subjects|||Number
2760299|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
2760300|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
2760301|NCT00805389|Secondary|Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase|Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||cells/mL||Inter-Quartile Range|Median
2760302|NCT00805389|Secondary|Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase|Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||cells/mL||Inter-Quartile Range|Median
2760303|NCT00805389|Secondary|Normalized Levels of Red Blood Cells and Platelets|Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||cells/mL||Inter-Quartile Range|Median
2760405|NCT00804648|Secondary|Conjunctival Staining - Nasal Grade|Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
2760406|NCT00804648|Secondary|Basic Schirmer's|Schirmer's measures basic tear function. The higher the number, the less dry the eye.|following 3 days of treatment||||mm of moisture||Standard Deviation|Mean
2760304|NCT00805389|Secondary|Levels of WBC, NEU, LYM, MON, EOS and BAS|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||IH normalized ratio||Inter-Quartile Range|Median
2760305|NCT00805389|Secondary|Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||IH normalized ratio||Inter-Quartile Range|Median
2760306|NCT00805389|Secondary|Normalized Levels of CRP|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30 and 37.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||IH Center normalized levels||Inter-Quartile Range|Median
2760307|NCT00805389|Secondary|Normalized Levels of WBC and of CPK|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||IH Center normalized ratio||Inter-Quartile Range|Median
2760308|NCT00805389|Secondary|Normalized Levels of C-reactive Protein (CRP)|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||IH Center normlized ratio||Inter-Quartile Range|Median
2760309|NCT00805389|Secondary|Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK)|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||IH Center normalized ratio||Inter-Quartile Range|Median
2760310|NCT00805389|Secondary|Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum|Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2760311|NCT00805389|Secondary|Number of HB-specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
2760312|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 37, 44 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
2760313|NCT00805389|Secondary|Anti-HB Antibody Concentrations in Serum, as Measured by CLIA|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 374 and 390|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2760314|NCT00805389|Secondary|Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||mIU/mL||95% Confidence Interval|Geometric Mean
2760315|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||mIU/mL||95% Confidence Interval|Geometric Mean
2760316|NCT00805389|Secondary|Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760317|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760318|NCT00805389|Secondary|Number of HB - Specific CD8+ T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 44, 60 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
2760319|NCT00805389|Secondary|Number of HB - Specific CD4+ T Cells|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 33, 37, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760320|NCT00805389|Secondary|Number of HB - Specific CD8+ T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
2760321|NCT00805389|Secondary|Number of HB - Specific CD4+ T Cells.|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760322|NCT00805389|Secondary|Number of HB - Specific CD8+ T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
2760323|NCT00805389|Secondary|Number of HB Specific CD4+ T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760324|NCT00805389|Secondary|Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
2760325|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30 and 60|Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30 or 60 time points.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760326|NCT00805389|Primary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.|At Day 44|Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 44 time point.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
2760327|NCT00805285|Secondary|C Reactive Protein|Higher values indicated increased disease activity|Week 0 and 8|The only patient enrolled withdrew; there was no data to analyze.||||||
2760328|NCT00805285|Secondary|Adverse Events||0, 2, 4, 6, 8, 11, 14, 20, 26, and 52 weeks||||Adverse events|||Number
2760329|NCT00805285|Secondary|ACTH Stimulation Test|An increase in cortisol after stimulation by ACTH is normal. Blood cortisol after ACTH stimulation should be greater than 18 - 20 mcg/dL, depending on the dose of cosyntropin used.|Week 16|The only patient enrolled withdrew; there was no data to analyze.||||||
2760330|NCT00805285|Primary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ)|Scores range from 10-70 where higher scores indicated better quality of life.|Week 0 and 8|The only patient enrolled withdrew; there was no data to analyze.||||||
2760331|NCT00805285|Primary|Simple Clinical Colitis Disease Activity (SCCAI)|Scores range from 0-19. Higher scores indicated increased disease severity. A score less than 3 is consistent with clinical remission.|0, 2, 4, 6, and 8 weeks|The only patient enrolled withdrew; there was no data to analyze.||||||
2760341|NCT00805194|Secondary|Change From Baseline in Tumour Size|"Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.~Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||percentage of change in tumor size in mm||95% Confidence Interval|Mean
2760332|NCT00805207|Secondary|Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis|"The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of [5,5,5-2H3]leucine into muscle proteins. [5,5,5-2H3]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model.~The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour."|Before and at the end of the intervention|"Not included in final analysis:~Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~Muscle not obtained = Testosterone - premenopausal women x 1; Progesterone postmenopausal women x 1; CPAP x 3; Glucocorticoid x 6; Control - baseline testing only x 6."|||%/h||Standard Deviation|Mean
2760333|NCT00805207|Secondary|VLDL-TG Plasma Clearance Rate (Medians)|VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.|Before and at the end of the interventions|"Not included in final analysis:~Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||mL/min||Inter-Quartile Range|Median
2760334|NCT00805207|Secondary|VLDL-TG Plasma Clearance Rate (Means)|VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.|Before and at the end of the interventions|"Not included in final analysis:~Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||mL/min||Standard Deviation|Mean
2760335|NCT00805207|Secondary|Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration|VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO).|Before and at the end of the interventions|"Not included in final analysis:~Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||mmol/L||Standard Deviation|Mean
2760336|NCT00805207|Primary|Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate|VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration.|Before and at the end of interventions|"Not included in final analysis:~Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||umol/min/L plasma||Standard Deviation|Mean
2760337|NCT00805194|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 42 months|Treated set- all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.|||% of participants|||Number
2760338|NCT00805194|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2760339|NCT00805194|Secondary|Quality of Life (QoL)|"Quality of life (QoL) was measured by standardised questionnaires (Health Status Self-Assessment Questionnaire (EQ-5D), EORTC Quality of life questionnaire - Core 30 (EORTC QLQ-C30), Quality of life questionnaire - lung cancer module (EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.~The following were the main points of interest:~Time to deterioration of cough (EORTC QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).~Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve"|From randomisation until cut-off date 15 February 2013|Randomised set|||months||Inter-Quartile Range|Median
2760407|NCT00804648|Secondary|Intraoclular Pressure||following 3 days of treatment||||mm of mercury||Standard Deviation|Mean
2760343|NCT00805194|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~As per RECIST v1.0 for target lesions : Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||% of participants|||Number
2760344|NCT00805194|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
2760345|NCT00805194|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.~As per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
2760346|NCT00805194|Secondary|Objective Tumour Response|"Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.~As per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||% of participants|||Number
2760347|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
2760348|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
2760349|NCT00805194|Secondary|Overall Survival (Key Secondary Endpoint)|"Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~A fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been."|From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )|Randomised Set|||months||Inter-Quartile Range|Median
2760350|NCT00805194|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) . Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)|Randomised Set|||months||Inter-Quartile Range|Median
2760351|NCT00805142|Secondary|Patient's Global Impression of Change (PGI-C)|PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||participants|||Number
2760352|NCT00805142|Secondary|Sleep Questionnaire Regarding the Quality of Sleep|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||participants|||Number
2760353|NCT00805142|Secondary|Sleep Questionnaire Regarding Number of Awakenings|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||awakenings||Standard Deviation|Mean
2760408|NCT00804648|Secondary|Corneal Staining Count|Assessed by the investigator using a slit lamp, counting the number of spots.|following 3 days of treatment||||Number of spots||Standard Deviation|Mean
2760409|NCT00804648|Secondary|Corneal Staining Grade|Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
2760354|NCT00805142|Secondary|Sleep Questionnaire Regarding Time to Sleep and Total Time Slept|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night.|Pre-dose (Day 1) and Day 20|THe PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||minutes||Standard Deviation|Mean
2760355|NCT00805142|Secondary|Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy|The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained.|Baseline up to 7 days after last dose of study treatment|The PPS included all participants enrolled excluding those with a major protocol violation.|||participants|||Number
2760356|NCT00805142|Secondary|Rescue Doses|The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants.|Day 12, 13, 14, 15, 16, 17, 18 and 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||mg per day||Standard Deviation|Mean
2760357|NCT00805142|Secondary|Pain Assessment Using Visual Analog Scale (VAS) Score|Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash.|Baseline and Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method.|||mm||Standard Deviation|Mean
2760358|NCT00805142|Secondary|Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale|Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded.|Baseline (Average of Day -1 and Day 0 morning scores), Day 20|The PPS included all participants enrolled excluding those with a major protocol violation.|||units on a scale||Standard Deviation|Mean
2760359|NCT00805142|Secondary|Percentage of Participants Who Achieve Dose Adjustment|Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period.|Day 3 up to Day 14|The PPS included all participants enrolled excluding those with a major protocol violation.|||percentage of participants||95% Confidence Interval|Number
2760360|NCT00805142|Primary|Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase|Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.|Day 15 up to Day 19|Per protocol set (PPS) included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2760361|NCT00805038|Secondary|Impediments to Successful Intervention||18-24 months|||||||
2760362|NCT00805038|Primary|Number of Steps Completed in Transplant Process|Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.|18-24 months|ITT analysis. Last observation carried forward for preliminary analyses.|||steps per participant||95% Confidence Interval|Mean
2760363|NCT00805025|Secondary|Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)|"The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change:~If the corresponding GRCQ score was in the no change group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score.~Then the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID."|Day 0 to Day 28|Participants who were evaluable for MCID and had both GRCQ and QOL-B change values at Day 28 (Visit 4) in any GRCQ domain were analyzed.|||units on a scale||Standard Deviation|Mean
2760410|NCT00804648|Secondary|Tear Film Break-up Time||following 3 days of treatment||||Seconds||Standard Deviation|Mean
2760364|NCT00805025|Primary|Convergent Validity of the Respiratory Domain of the QOL-B|Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.|Day -14|Participants were analyzed for respiratory domain score at Day 0 against each of the other variables; those with data for both the respiratory domain score and each variable are reported.|||Pearson correlation coefficient|||Number
2760365|NCT00805025|Primary|Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)|"Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability.~The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life."|Day -14 to Day 0|Participants who were treated and had any QOL-B measurements at both Screening and Day 0 (Visits 1 and 2) were analyzed.|||Intraclass Correlation Coefficient|||Number
2760366|NCT00804999|Primary|HRT Corneal Scan|Looking for cell density|baseline and 2 hours||||cells/mm^3||Standard Deviation|Mean
2760367|NCT00804986|Secondary|Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 12 Weeks||||percentage of participants|||Number
2760368|NCT00804986|Secondary|Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint|Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)|||millimeters||Standard Error|Least Squares Mean
2760369|NCT00804986|Secondary|Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint|DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)|||units on a scale||Standard Error|Least Squares Mean
2760370|NCT00804986|Secondary|Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint|Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)|||units on a scale||Standard Error|Least Squares Mean
2760371|NCT00804986|Secondary|Change in Fasting Weight From Baseline to Week 12 Endpoint|LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
2760372|NCT00804986|Secondary|Change in Fasting Lipids From Baseline to Week 12 Endpoint|Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2760373|NCT00804986|Secondary|Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
2760411|NCT00804648|Secondary|Conjunctival Hyperemia|Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
2760374|NCT00804986|Secondary|Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
2760375|NCT00804986|Secondary|Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||milligrams per minute per deciliter||95% Confidence Interval|Least Squares Mean
2760376|NCT00804986|Secondary|Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint|Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2760377|NCT00804986|Secondary|Total Average Concentration (Cavg) of LY2428757|Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).|4 weeks, 6 weeks, 8 weeks, 10 weeks|All randomized participants|||nanograms per milliliter (ng/mL)|||Number
2760378|NCT00804986|Secondary|Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study|Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.|baseline through 16 weeks|All randomized participants|||participants|||Number
2760379|NCT00804986|Secondary|Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint|The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||millimeters (mm)||Standard Error|Least Squares Mean
2760380|NCT00804986|Primary|Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint|LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2760381|NCT00804908|Secondary|Time to Neurological/Brain Metastases Progression|Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
2760382|NCT00804908|Secondary|Disease Control Rate|The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Week 8|ITT population defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2760383|NCT00804908|Secondary|Time to Disease Progression|The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
2760384|NCT00804908|Secondary|Objective Response Rate|The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|All subjects in the ITT population (defined as all randomized participants) with measurable disease.|||percentage of participants||95% Confidence Interval|Number
2760385|NCT00804908|Secondary|6-month Progression-Free Survival Rate|The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2760386|NCT00804908|Secondary|12-Month Overall Survival (OS) Rate|The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months.|ITT population defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2760387|NCT00804908|Secondary|Overall Survival (OS): Time to Event|OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints.|Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
2760388|NCT00804908|Primary|Progression-Free Survival (PFS): Time to Event|PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided.|Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
2760389|NCT00804843|Primary|Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay|Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol - Free Cholesterol.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were to be included in the analysis. This was not performed due to technical concerns. Instead, the cholesterol content determination, if performed, will use mass spectrometry approach and would be an exploratory objective.||||||
2760390|NCT00804843|Primary|Plaque Instability Protein Composite Score|Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.|||Score||Standard Deviation|Mean
2760391|NCT00804843|Primary|Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis|"Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation (Hot biomarkers) & 25 biomarkers associated with stability (Cold biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 cold genes, and subtracting the average Ct for the 60 hot genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed)."|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.|||Cycle threshold (Ct)||Standard Deviation|Mean
2760392|NCT00804713|Other Pre-specified|TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results||48-72 hours after adminstration||||participants|||Number
2760393|NCT00804713|Other Pre-specified|Battey Skin Test Result|Battey skin test positive results defined as >= 100 mm reaction. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after administration||||participants|||Number
2760394|NCT00804713|Other Pre-specified|T-Spot Result|Positive T-Spot results. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours||||participants|||Number
2760395|NCT00804713|Secondary|Positive QFT-GIT Result|The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after enrollment||||participants|||Number
2760396|NCT00804713|Primary|TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.|"Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.)~The number of 1803 is used here because that is the number for which valid results were available for all 4 tests.~The number presented in each category is the number of participants that had positive results.~We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol."|48-72 hrs post administration||||participants|||Number
2760397|NCT00804687|Secondary|Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1|The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.|Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||square centimeter (cm^2)||Standard Deviation|Mean
2760398|NCT00804687|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2760399|NCT00804687|Secondary|Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).|2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||units on a scale * hours||Standard Deviation|Mean
2760400|NCT00804687|Primary|Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry|The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.|2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|Intent to treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||square centimeter*hour (cm^2*h)||Standard Deviation|Mean
2760414|NCT00804596|Secondary|Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.|1-2 hours|Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results.|||Number of Duplicate Results (n=74x2)|||Number
2760415|NCT00804596|Primary|Percentage of Participants Rated as <=3 (Comprehension of Labeling)|"Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:~Successful in performing tasks correctly without assistance~Successful after being referred to user instructions~Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|1-2 hours|per protocol|||percentage of participants|||Number
2760416|NCT00804570|Secondary|Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint|The GSRS is a clinician-administered scale used to assess upper and lower gastrointestinal physical symptoms. 15 items covering domains of abdominal pain, reflux syndrome, indigestion syndrome, diarrhea syndrome, and constipation syndrome were assessed with a 1-week recall period. Total scores range from 0-45. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760417|NCT00804570|Secondary|Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint|The revised CIWA-Ar scale measured the severity of alcohol withdrawal by rating 10 signs and symptoms: nausea; tremor; autonomic hyperactivity; anxiety; agitation; tactile, visual, and auditory disturbances; headache; and disorientation. Total scores range from 0-67. Higher scores indicate greater severity of withdrawal.|Baseline through Week 16|Participants who took at least one dose of study drug.|||participants|||Number
2760418|NCT00804570|Secondary|Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint|Orthostatic pulse rate is the pulse rate measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||beats per minute||Standard Error|Least Squares Mean
2760419|NCT00804570|Secondary|Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint|Orthostatic BP is the BP measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16||||mmHg||Standard Error|Least Squares Mean
2760420|NCT00804570|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|Percentage of participants had one or more TEAEs during treatment period. TEAE is a worsening or new occurrence of adverse event during treatment compared to baseline.|Baseline through Week 16|Participants who took at least one dose of study drug.|||percentage of participants|||Number
2760421|NCT00804570|Secondary|Percentage of Participants Discontinuation Due to Adverse Events (AEs)|Percentage of participants discontinued study due to one or more AEs.|Baseline through Week 16|Participants who took at least one dose of study drug.|||percentage of participants|||Number
2760422|NCT00804570|Secondary|Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
2760423|NCT00804570|Secondary|Change From Baseline in Supine Pulse Rate at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2760424|NCT00804570|Secondary|Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2760425|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Volume of Distribution|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.|||Liter (L)||Standard Error|Mean
2760426|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Clearance|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.|||Liter/hour (L/hr)||Standard Error|Mean
2760427|NCT00804570|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint|EWPS is a self-rated work productivity scale that assesses such topics as work hours, work missed, and behaviors and feelings related to the workplace. The EWPS will be completed only by subjects who work outside the home. There are 25 items and total scores range from 0-100. Higher scores indicate poorer productivity. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760428|NCT00804570|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint|Q-LES-Q-SF is a self-report instrument that assesses the degree of enjoyment and satisfaction in daily life activities. The domains include: social relationships, living or house situation, and physical health. Total scores range from 14-70. Higher scores indicate better quality of life. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760429|NCT00804570|Secondary|Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint|Thoughts About Abstinence Scale was to measure participant's commitment to abstinence. It includes 3 items on a scale of 1-10: own desire to stop drinking (1=no desire to quit); own expectation of success in quitting (1=lowest expectation of success); how difficult to quit and remain abstinent (1=lowest amount of difficulty); and their goal related to alcohol use (scale of 1-7: 1=having no goal, up to total abstinence at 6 [7 was none of 6 above]). Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760430|NCT00804570|Secondary|Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint|The BIS-11 is a 30-item, self-administered impulsivity scale. Motor, cognitive, and non-planning domains are assessed and a total score is computed. This scale has previously been used in substance-abusing populations. Total scores range from 30-120. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760431|NCT00804570|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Participant was asked to rate how much he or she has been bothered by each symptom over the past week. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). Total scores range from 0 to 63. The higher the score, the more severe the anxiety symptoms. LS Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760432|NCT00804570|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint|The BDI-II contains 21 items that characterize how the subject was feeling in the past 2 weeks. There is a 4-point scale for each item ranging from 0 to 3 (0=no depression; 3=very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760433|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint|AST is a potential biomarker for LY2196044 efficacy as decreases reflect decreased alcohol consumption. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||ratio||Standard Error|Geometric Mean
2760434|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint|Gamma-Glutamyltransferase (GGT) and %CDT will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||ratio||Standard Error|Geometric Mean
2760435|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint|GGT and carbohydrate-deficient transferrin (%CDT) will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||ratio||Standard Error|Geometric Mean
2760436|NCT00804570|Secondary|Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint|DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. DrInC-2R provides a measurement since the last interview. Total scores range from 0-150, and higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760437|NCT00804570|Secondary|Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint|Cravings will be assessed using the OCDS. The OCDS is a 14-item self-rating instrument. Total scores range from 0-40. Higher scores indicate more obsessive and craving. Least Squares (LS) Mean value was controlled for treatment, site, visit, gender, history, baseline, gender*history, treatment*visit, baseline*visit, gender*treatment, gender*treatment*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2760438|NCT00804570|Secondary|Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||number of drinks/heavy drinking day||Standard Error|Least Squares Mean
2760439|NCT00804570|Secondary|Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||number of drinks/drinking day||Standard Error|Least Squares Mean
2760440|NCT00804570|Secondary|Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint|The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the percentage of days abstinent. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||percentage of days||Standard Error|Least Squares Mean
2760441|NCT00804570|Secondary|Change From Baseline in Drinks Per Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed per day. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||number of drinks/day||Standard Error|Least Squares Mean
2760442|NCT00804570|Primary|Percentage of Heavy Drinking Days at Week 16 Endpoint|The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||percentage of days||Standard Error|Least Squares Mean
2760443|NCT00804349|Secondary|Visual Analog Scale of Shortness of Breath|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.|Concurrent|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.||||||
2760444|NCT00804349|Secondary|Length of Stay|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.|Concurrent|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.||||||
2760445|NCT00804349|Secondary|Readmission|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.|30 days post discharge|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.||||||
2760446|NCT00804349|Primary|Reduction in Episodic Oxygen Desaturation|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.|Concurrent|0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.||||||
2760447|NCT00804193|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis|6 weeks||||participants|||Number
2760448|NCT00804193|Secondary|Proportion of Subjects With Mycological Cure|Potassium hydroxide [KOH] wet mount negative and fungal culture negative|6 weeks||||participants|||Number
2760449|NCT00804193|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure|6 weeks|Per protocol population|||participants|||Number
2760450|NCT00804141|Secondary|Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up|Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing.|Baseline, follow-up (14 days [Week 49 to 50])|All participants who received at least one dose of study drug. Here, 'Number analyzed' signifies participants evaluable at specified timepoint.|||BM/week||Standard Deviation|Mean
2760482|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.|||participants|||Number
2760451|NCT00804141|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline up to Week 50|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2760452|NCT00803959|Secondary|Stress Test at 12 Mos|A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.|Screen and 12 months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Of these, only 225 in the UDS arm and 222 in the no UDS had stress test data at 12 months.|||percentage of participants|||Number
2760453|NCT00803959|Secondary|Patient Satisfaction With Treatment Outcome|A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760454|NCT00803959|Secondary|Moderate or Severe Severity as Measured by the PGI-S|"The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a 3 corresponding to the moderate category or a 4 corresponding to the severe category at the 12 month visit."|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. One woman was missing PGI-S data in the UDS arm and was excluded leaving n=271 in the UDS arm.|||percentage of participants|||Number
2760455|NCT00803959|Secondary|Change in Severity as Measured by the PGI-S|The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760456|NCT00803959|Secondary|Change in Quality of Life as Measured by the SF-12|The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760457|NCT00803959|Secondary|Change in Quality of Life as Measured by the IIQ|Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760458|NCT00803959|Secondary|Change in MESA Urge Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760459|NCT00803959|Secondary|Change in MESA Stress Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760460|NCT00803959|Secondary|Change in Severity as Measured by the ISI|Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760461|NCT00803959|Secondary|Change in Bother as Measured by the UDI|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
2760462|NCT00803959|Secondary|Patient Global Impression Index|"Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants, How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage? Responses are on a 7-point scale from 1 meaning very much better to 7 meaning very much worse. Values of very much better (1) or much better (2) were considered to have perceived improvement according to this criteria. Values of 3 or greater were not (e.g. a little better, no change, a little worse, much worse or very much worse). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence."|12 Months|315 women were randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Two were missing PGI-I data in the UDS arm and 4 in the no UDS arm; sample size was 262 in no UDS arm and 270 in the UDS arm.|||percentage of participants|||Number
2760463|NCT00803959|Secondary|Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.|Baseline, 12 mos|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||percentage of participants|||Number
2760464|NCT00803959|Primary|"Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and Very Much or Much Better on the Patient Global Impression of Improvement Measure at 12 Mos."|"Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of very much better or much better at 12 months."|12 Months|There were 315 women randomized to each of the arms. In the no UDS arm (and UDS arm), 49 (43) did not have primary outcome data, leaving 266 (272) included in the ITT analysis. Of these, 259 (264) were included in the PP analysis with primary outcome data. The PP analysis was the primary analysis because the outcome was a non-inferiority endpoint.|||percentage of participants|||Number
2760465|NCT00803790|Secondary|Part II : Maximum Concentration (Cmax) of Vitamin D|Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Periods 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.|||ng/ml||Standard Deviation|Least Squares Mean
2760466|NCT00803790|Primary|Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D|The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Period 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.|||ng*hr/mL||Standard Deviation|Least Squares Mean
2760467|NCT00803790|Primary|Part 1: Urinary Excretion of Alendronate|Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.|Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)|220 participants of the 251 enrolled in Part 1 were included in the statistical analysis. 31 participants were excluded: 23 were enrolled but did not complete both study periods and 8 participants had incomplete urine profiles in one or both periods.|||μg||Standard Deviation|Least Squares Mean
2760483|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Maintenance Phase|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.|||participants|||Number
2760468|NCT00803777|Secondary|Average Within Replicate Coefficient of Variation CV (Precision)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|1-2 hours|Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.|||percentage CV|||Number
2760469|NCT00803777|Secondary|Number of Participants Rated as <=2 (Labeling Comprehension)|"Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:~Successful in performing tasks correctly without assistance~Successful after study staff prompted participant to review User Guide.~Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)~Subject did not perform task correctly and study staff intervention was required."|1-2 hours|For 2 different subjects, study staff did not rate subject success at 1 task.|||participants|||Number
2760470|NCT00803777|Secondary|Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies|The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences|1-2 hours|Some subjects >=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject’s results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.|||Number of BG results in zone (n=79x2)|||Number
2760471|NCT00803777|Primary|Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results|Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.|1-2 hours|One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.|||number of Subject BGM Results (n=146x2)|||Number
2760472|NCT00803777|Primary|Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.|1-2 hours|Some subjects >=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)|||number of capillary results (n=79x2)|||Number
2760473|NCT00803751|Secondary|POGO Score With 2nd Laryngoscopy|POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.|Before patient is intubated||||Score||Standard Deviation|Mean
2760474|NCT00803751|Primary|Quality of Laryngeal View Obtained With 2nd Laryngoscopy|The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.|during laryngoscopy prior to intubation (few minutes prior to intubation)||||Participants|||Number
2760475|NCT00803751|Secondary|POGO Score With 1st Laryngoscopy|POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.|Before patient is intubated (few minutes before intubation)||||Score||Standard Deviation|Mean
2760476|NCT00803751|Secondary|Time Taken for Intubation||throughout the intubation procedure||||seconds||Standard Deviation|Mean
2760477|NCT00803751|Primary|Number of Intubation Attempts|Number of participants with the indicated number of intubation attempts (1/2/3)|during intubation prior to surgery||||Participants|||Number
2760478|NCT00803751|Primary|Quality of Laryngeal View Obtained on Comarck Lehane Classification|The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.|during laryngoscopy prior to intubation. Few minutes before intubation||||Participants|||Number
2760479|NCT00803738|Secondary|Proportion of Subjects With Clinical Cure|"A subject was considered a clinical cure if all of the following were satisfied:~All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.~Total signs and symptoms did not worsen at any time following completion of the study treatment.~Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.~The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.~The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products"|Visit 3: Day 22-31|per protocol population|||participants|||Number
2760480|NCT00803738|Secondary|Proportion of Subjects With Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.|Visit 3: Day 22-31|Per protocol population|||participants|||Number
2760484|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.|||participants|||Number
2760485|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.|||participants|||Number
2760486|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Maintenance Phase|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.|||participants|||Number
2760487|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.|||participants|||Number
2760488|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
2760489|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
2760490|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
2760491|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
2760492|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
2760493|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
2760512|NCT00803686|Secondary|AUCInhibition=Hours*%P|The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.|12 Hours||||hours*%P||Standard Deviation|Mean
2760909|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)|Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760494|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
2760495|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
2760496|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
2760497|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||pg/mL||95% Confidence Interval|Least Squares Mean
2760498|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
2760499|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||pg/mL||95% Confidence Interval|Least Squares Mean
2760500|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases|||participants|||Number
2760501|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases|||participants|||Number
2760502|NCT00803712|Secondary|Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases|||participants|||Number
2760503|NCT00803712|Secondary|Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases|||participants|||Number
2760504|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52|||participants|||Number
2760505|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26|||participants|||Number
2760506|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52|||participants|||Number
2760507|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26|||participants|||Number
2760508|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52|||participants|||Number
2760509|NCT00803712|Secondary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52|||participants|||Number
2760510|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26|||participants|||Number
2760511|NCT00803712|Primary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26|||participants|||Number
2760513|NCT00803686|Secondary|Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women|See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition).|12 hours|Data from Part 1 (crossover Periods 1 and 2) were pooled to give CTx-1 mean data for the oral rsCT tablet group (n = 12) and for the oral placebo group n = 12). Part 2, open-label, non-crossover, compared the CTx-1 results after oral rsCT (n = 5) with those after Fortical(n = 4. The % inhibition is reported first.|||Hours||Standard Deviation|Mean
2760514|NCT00803686|Primary|Pharmacodynamic Effect of Oral Calcitonin|C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc|12 hr|Not applicable. All participants who received treatment were included.|||percentage of time-matched placebo respo||Standard Deviation|Mean
2760515|NCT00803647|Secondary|Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.||2 years|Patients with R0 resection|||months||95% Confidence Interval|Median
2760516|NCT00803647|Secondary|Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by PET/CT, CT scan, MRI or spiral CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective clinical Response Rate (cRR) = CR + PR during the 3 preoperative cycles, among the treated patients.|8 months||||percentage of participants||95% Confidence Interval|Number
2760517|NCT00803647|Secondary|Overall Survival (OS). Time From Study Entry Until Death From Any Cause.|The percentage of patients alive at 18 months.|18 months||||percentage of participants||95% Confidence Interval|Number
2760518|NCT00803647|Primary|Reported Adverse Events.|19 participants experienced at least one adverse event. There were a total of 95 adverse events reported. (Note: multiple occurrences of the same adverse event in one individual are counted only once.) Refer to the Adverse Events section for specifics. The Other Adverse Events section lists only those events occurring above 5% frequency.|8 months||||adverse events|||Number
2760519|NCT00803647|Primary|The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).||8 months|All 20 patients were included in this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2760520|NCT00803634|Primary|Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes|Analysis of the percentage of patients achieving both components of this composite endpoint (attainment of the initial prespecified SBP target range and a 15% reduction in SBP from baseline) was calculated within each treatment group using the number of mITT patients achieving the SBP reduction goal divided by the number of mITT patients, and multiplied by 100.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
2760521|NCT00803634|Secondary|Number of Patients That Require Intubation During Study Drug Administration up to 96 Hours|The number of patients requiring intubation was calculated based on the total number of mITT patients.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Patients|||Number
2760522|NCT00803634|Secondary|Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours)|The percent of patients with at least one episode of SBP <90 mm Hg was calculated as the number of mITT patients who had at least one episode of SBP<90 mm Hg during study drug administration up to 96 hours divided by mITT patients, and multiplied by 100 for each treatment group.|Initiation through termination of study drug (up to 96 hours)|Safety population: All randomized and eligible patients who were dosed with study drug.|||Percentage of patients||95% Confidence Interval|Number
2760523|NCT00803634|Secondary|Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment|The percentage of patients who received any alternative IV antihypertensive drug at any time during the study drug treatment period (up to 96 hours) was calculated using mITT patients within each treatment group.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
2760560|NCT00803283|Secondary|Patient's Global Assessment on Effectiveness|"Participants will evaluate effectiveness by providing rating on the question 'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent."|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760524|NCT00803634|Secondary|Time to Use Other IV Antihypertensives During the Study Drug Administration|The length of time to use other IV antihypertensive agents was defined as the duration in hours from the initiation of study drug through the time when any other concomitant IV antihypertensive agent was administered, thus, representing the time period without use of any other concomitant IV antihypertensive agent. Median time to use other IV antihypertensive agents was obtained using Kaplan-Meier method. If a patient did not receive any concomitant IV antihypertensive during the 96-hour treatment period, this patient was considered censored at 96 hours. If study drug was stopped less than 96 hours and the patient has no concomitant IV antihypertensive agent, the patient was considered censored when study drug was stopped.|Initiation of study drug through any other concomitant IV antihypertensive agent administered, up to 96 hours|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Hours||95% Confidence Interval|Median
2760525|NCT00803634|Secondary|Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point|A validated visual analog scale (VAS) with a horizontal ruler showing increments from 0 to 100 mm with 0 = Best and 100 = Worst was used. The test was asked from the patient's perspective and had to be administered with patient sitting. Relative change in VAS from baseline is the value at each time point minus the baseline value. Relative change from baseline was summarized descriptively (with associated two-tailed 95% CIs of the mean values) at 15, 30 and 45 minutes and at 1, 2, 3 hours and 12 hours, and 1 hour post termination of study drug treatment.|Baseline (immediately prior to study drug administration) through 1 hour after study drug termination|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||millimeters (mm)||Standard Deviation|Mean
2760526|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the entire study drug treatment period (up to 96 hours) was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
2760527|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the first 30 minutes was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
2760528|NCT00803634|Secondary|SBP Area Under the Curve (AUC) Outside Prespecified Target Range|The magnitude and duration of SBP excursions was calculated as the area under the curve (AUC) for each patient, using the trapezoidal rule, related to time (in minutes) that each patient's SBP was outside the target range. AUC was determined based on data collected from the initiation of study medication through the end of monotherapy treatment up to 96 hours, normalized per hour, and expressed as mmHg × minute/hour.|Initiation of study drug through end of monotherapy (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||mm Hg x min/h||Standard Deviation|Mean
2760529|NCT00803634|Secondary|Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes|The percentage of patients reaching this endpoint was calculated within each treatment group using the number of mITT patients reaching the endpoint divided by the number of mITT patients, and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
2760530|NCT00803634|Primary|Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes|Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, or another antihypertensive agent was administered, the patient was censored at 30 minutes or the time when another antihypertensive agent is given, whichever came first.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Minutes||95% Confidence Interval|Median
2760531|NCT00803595|Secondary|Time for Body Temperature to Return to Normal|Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days||||hours||95% Confidence Interval|Median
2760573|NCT00803114|Secondary|Side Effects|Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum|at 24 hours postpartum|||||||
2760574|NCT00803114|Secondary|Maternal Satisfaction With Perineal Pain Management|"5 point Likert scale asking for agreement with the statement I was satisfied with my pain relief for the pain in my bottom during the first day after delivery. Scale ranged from strongly disagree to strongly agree."|at 24 hours postpartum||||participants|||Number
2760532|NCT00803595|Primary|Time to Alleviation of Influenza Illness|"The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were absent or mild. Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored."|15 days|Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data.|||hours||95% Confidence Interval|Median
2760533|NCT00803569|Secondary|Number of Patients With NY-ESO-1 and LAGE-1 Antigen Positivity|Blood samples were collected for measurement of NY-ESO-1 and LAGE-1 antigen positivity at Baseline and Weeks 4, 8 ,12, 16, 20, and 24 (end of study). Antibody testing was performed by enzyme-linked immunosorbent assay (ELISA).|Baseline through Week 24|Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.|||Participants|||Count of Participants
2760534|NCT00803569|Secondary|Median Cancer Antigen 25 (CA-125) Values on Study|Blood samples were collected for CA-125 testing as a component of disease evaluations at Baseline and Weeks 8, 12, 16, 20, and 24 (end of study) or every 2 to 3 months on study according to standard institutional practice.|Baseline through Week 24|Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.|||U/mL||Full Range|Median
2760535|NCT00803569|Secondary|Median Progression-free Survival (PFS)|PFS was calculated from the date of the first dose of study drug to the date of documented progression or death, whichever occurred first. Patients without disease progression or death had their observation time censored at the date of the last valid disease assessment. PFS was summarized using Kaplan-Meier product-limit estimators.|Baseline and up to approximately 24 weeks|Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.|||days||Full Range|Median
2760536|NCT00803569|Secondary|Number of Patients With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0) at baseline, at Week 12 (± 28 days), and at Week 24 (end of study). Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Baseline and Weeks 12 and 24|Patients with data available from at least 1 post-baseline response assessment. One patient discontinued the study prior to the Week 12 response assessment.|||Participants|||Count of Participants
2760537|NCT00803569|Primary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.|Continuously for up to 26 weeks|Patients who received at least 1 dose of study drug.|||Participants|||Count of Participants
2760538|NCT00803543|Primary|Rate of Asymptomatic HSV-2 Genital Shedding|Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.|24 weeks||||Proportion of days|Total Number of Days Assessed||Number
2760539|NCT00803543|Primary|Number of Participants With an HIV Viral Load of <500 Copies/ml|Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks|24 weeks||||Participants|||Number
2760540|NCT00803543|Primary|CD4 Count|CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml|24 weeks||||cells/ml||Full Range|Mean
2760541|NCT00803543|Primary|Herpes Simplex Virus Type 2 Recurrence|Number of recurrences of genital herpes|24 Weeks|No participants reported genital herpes recurrence during the study.|||Recurrence|||Number
2760542|NCT00803517|Secondary|Best Corrected Visual Acuity|Best-corrected visual acuities were obtained with Snellen charts. Snellen's visual acuity was converted logarithm of the minimum angle of resolution (logMAR) for statistical analysis.|baseline, 1 month, 3 months, 6 months||||logMAR||Standard Deviation|Mean
2760543|NCT00803517|Primary|Multifocal Electroretinogram Amplitudes|"Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram.~The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines."|baseline, 1 month, 3 months, 6 months||||microvolts||Standard Deviation|Mean
2760544|NCT00803452|Primary|Global Response to Therapy|Global Response to Therapy (itch, dryness, burning and swelling of eyes) as assessed with a questionnaire completed by the subjects. The questionnaire asked subjects to rate their improvement on a scale from 4 to 0 with 4 being resolution of symptoms and 0 being no improvement. Data reported here represent the number of eye of subjects that reported that their symptoms were resolved or improved in each eye.|4 weeks||||eyes|eyes||Number
2760545|NCT00803413|Primary|Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)|Patients were asked to indicate their perception about their LBP intensity with a cross on a line without marks, ranging from 1 (very light pain) through 10 (very strong pain)|6 months||||milimeters||Standard Deviation|Mean
2760546|NCT00803413|Secondary|Spine Flexibility (3rd Fingertip to Floor - 3FF).|Patients in up-right position with joined feet and stretched out arms were asked to bend the spine as much as possible without bending the knees; the least achieved distance between the 3rd fingertip and the floor was measured in centimeters with a proper rule.|6 months||||centimeters||Standard Deviation|Mean
2760575|NCT00803114|Secondary|Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic|"Participants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with no pain in my bottom to the other end anchored with the worst pain in my bottom that I can imagine"|by 24 hours postpartum||||scores on a scale||Standard Deviation|Mean
2760547|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)|The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline and 12 weeks|For this outcome the baseline number of participants is zero as at the first visit patients have not received any treatment yet, thus they cannot be assessed with a scale that measures improvement at their first visit. This scale will only be applied along weeks 2, 4, 8, and 12, after patients have received their corresponding treatments.|||Units on a scale||Standard Deviation|Mean
2760548|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)|The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient's mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill).|Baseline and 12 weeks||||Units on a scale||Standard Deviation|Mean
2760549|NCT00803400|Primary|Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|Baseline and 12 weeks||||Units on a scale||Standard Deviation|Mean
2760550|NCT00803361|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
2760551|NCT00803361|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
2760552|NCT00803361|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.|Baseline, Week 15|Participants with a baseline and at least one post-baseline value.|||Units on a scale||Standard Deviation|Mean
2760553|NCT00803361|Secondary|Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
2760554|NCT00803361|Secondary|Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Week 15|Participants with at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
2760555|NCT00803361|Secondary|Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a scale||Standard Deviation|Mean
2760556|NCT00803361|Primary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a scale||Standard Deviation|Mean
2760557|NCT00803283|Secondary|Mean Total Daily Dose (TDD) of Study Medication|Mean total daily dose of study medication taken during study will be recorded by participants.|Baseline up to day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760558|NCT00803283|Secondary|Number of Times the Pain Medication Required for Breakthrough Pain|The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.|Baseline up to Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760559|NCT00803283|Secondary|Investigator's Global Assessment on Effectiveness|"Investigator will evaluate effectiveness by providing rating on the question 'what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent."|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760576|NCT00803114|Secondary|Time to First Request for Analgesia|All participants requested analgesia at least once during their hospitalization|Hours||||hours||Standard Deviation|Mean
2760561|NCT00803283|Secondary|"BPI Questionnaire Item Pain Interference Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Interference will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760562|NCT00803283|Secondary|"BPI Questionnaire Item Pain Relief Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Relief will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760563|NCT00803283|Secondary|"BPI Questionnaire Item Pain Intensity Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Intensity will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760564|NCT00803283|Secondary|"BPI Questionnaire Item 6 How Much Pain You Have Right Now Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 how much pain you have right now will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760565|NCT00803283|Primary|"BPI Questionnaire Item 3 Worst Pain Score at Day 28"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760566|NCT00803283|Primary|"Brief Pain Inventory (BPI) Questionnaire Item 3 Worst Pain Score at Day 14"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 14|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
2760567|NCT00803270|Secondary|Optimal Outcome of Treatment at 3 Months|"Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe."|3 months|Participants who attended 3 month follow-up visit|||participants|||Number
2760568|NCT00803270|Primary|Optimal Outcome of Treatment at 6 Months|"Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe."|6 Months|Participants who attended 6 month follow-up visit|||participants|||Number
2760569|NCT00803244|Post-Hoc|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient's daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.~The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).~The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment.|||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
2760570|NCT00803244|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.~Participants assessed daily, during the pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.|||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
2760571|NCT00803179|Secondary|Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy||14 months|||||||
2760572|NCT00803179|Primary|Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy||14 months|||||||
2760578|NCT00803101|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs).|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs|The Intention-to-Treat Safety (ITT-S) population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.|||participants|||Number
2760579|NCT00803101|Secondary|Percentage of Participants Who Received Red Blood Cells|Red blood cells were PRBCs and whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
2760580|NCT00803101|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
2760581|NCT00803101|Secondary|Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood|The total units of transfused PRBCs or whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||units of PRBCs or whole blood||Standard Deviation|Mean
2760582|NCT00803101|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From pre-infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of normal||Standard Deviation|Mean
2760583|NCT00803101|Primary|Percentage of Participants Who Had a Rapid Decrease of the INR|A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after the end of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
2760584|NCT00803101|Primary|Percentage of Participants Achieving Hemostatic Efficacy During Surgery|"Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of excellent or good, and 'non-effective' was a hemostatic efficacy rating of poor/none."|From the start of infusion until the end of surgery|The Intention-to-Treat Efficacy ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
2760585|NCT00803062|Other Pre-specified|Prevalence of Active Smoking|An estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.|Up to 5 years|||||||
2760586|NCT00803062|Other Pre-specified|Number of CTCs|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
2760587|NCT00803062|Other Pre-specified|Levels of Tumor Measures of Angiogenesis|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
2760588|NCT00803062|Other Pre-specified|Levels of Cell-free DNA in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
2760589|NCT00803062|Other Pre-specified|Levels of Angiogenesis Markers in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
2760590|NCT00803062|Other Pre-specified|Health-related Quality of Life|Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.|Up to 9 months after course 1|||||||
2760591|NCT00803062|Other Pre-specified|Extent of Nicotine Dependence|Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.|Up to 5 years|||||||
2760592|NCT00803062|Primary|To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.|The number of patients on each arm who have Grade 3 AE or higher toxicity.|From date of enrollment until 30 days after treatment completion|Eligible and treated patients|||Participants|||Count of Participants
2760593|NCT00803062|Primary|Tumor Response|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.|Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.|All randomized patients.|||percentage of participants||95% Confidence Interval|Number
2760594|NCT00803062|Primary|Progression-free Survival|"Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)|All randomized patients.|||months||95% Confidence Interval|Median
2760595|NCT00803062|Primary|Overall Survival|The observed length of life from randomization into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|All randomized patients.|||months||95% Confidence Interval|Median
2760596|NCT00803049|Secondary|Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization|BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).|Baseline, Week 192|ITT (LTS6050 population). Number of participants analyzed=participants with available data for this outcome measure.|||millilitres (ml)||Standard Deviation|Mean
2760597|NCT00803049|Secondary|Annualized MS Relapse Rate (ARR): Poisson Regression Estimates|"ARR was obtained from total number of confirmed relapses that occurred during treatment period divided by sum of treatment durations in LTS6050 study only. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever was to be confirmed by an increase in EDSS score or Functional System (FS) scores. EDSS: an ordinal scale qualifies disability. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). FSS: to assess the neurological function. Total score range: 0 (normal) - 6(worse), higher scores = worse neurological function. To account for the different treatment duration among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Up to 8 years since LTS6050 randomization|ITT(LTS6050) population: all participants who were randomized in the LTS6050 study and had at least 1-day IMP exposure during the LTS6050 study.|||relapses per participant-year||95% Confidence Interval|Number
2760598|NCT00803049|Secondary|Percentage of Participants Free of Sustained Disability Progression (DP)|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.|Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049 [NCT00134563] + LTS6050) population.|||percentage of participants|||Number
2760624|NCT00802880|Secondary|Correlate Time to Progression With Best Metabolic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.|||months||95% Confidence Interval|Median
2760910|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)|Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760599|NCT00803049|Secondary|Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 24 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). Probability of DP at 24 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.|||Probability||95% Confidence Interval|Number
2760600|NCT00803049|Secondary|Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP defined as sustained increase of at least 1 point from baseline (EFC6049) expanded disability status scale (EDSS) score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to Multiple Sclerosis [MS]). Probability of DP at 12 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.|||Probability||95% Confidence Interval|Number
2760601|NCT00803049|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.|Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks|Safety population: all participants randomized in the LTS6050 study and exposed to IMP during the LTS6050 study treatment period, regardless of the amount of treatment administered. The safety analysis was conducted as the treatment received.|||percentage of participants|||Number
2760602|NCT00803023|Secondary|Tolerability Assessed by Adverse Events||4 weeks|||||||
2760603|NCT00803023|Primary|Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects||4 weeks||||participants|||Number
2760604|NCT00803010|Secondary|2 Year Post Transplant Overall Survival (OS) Rate|Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause .|2 years|All participants who received treatment|||percentage of participants||95% Confidence Interval|Number
2760605|NCT00803010|Secondary|Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)|Absolute numbers of Treg at designated time points according to study arm. MTX = methotrexate/tacrolimus-treated patients; SIR = sirolimus/tacrolimus-treated patients; Treg absolute number units = number of cells/microL. A two-sided Wilcoxon's rank-sum test was employed to test differences in percent Treg (% Treg/total CD4+ cells).|30 days and 90 days||||Cells/MicroL||95% Confidence Interval|Median
2760606|NCT00803010|Primary|Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant|"Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3.~Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme.~Acute GVHD classified as the following:~classic acute GVHD - onset within 100 days after transplant~persistent - acute GVHD with onset prior to day 100 and without resolution beyond day 100~recurrent - acute GVHD recurrent after prior episode of acute GVHD~late acute GVHD - syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days"|100 Days Post Transplant|All participants who received treatment|||percentage of participants||95% Confidence Interval|Number
2760607|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 9 Months||||units on a scale||Standard Deviation|Mean
2760608|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 6 Months||||units on a scale||Standard Deviation|Mean
2760609|NCT00802997|Primary|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2760625|NCT00802880|Secondary|Correlate the Time to Progression With Best Anatomic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no anatomic response recorded.|||months||95% Confidence Interval|Median
2760610|NCT00802945|Secondary|Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. All AEs were assessed for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. If a particular AE was not listed in the NCI CTCAE Version 3.0, the following criteria were used: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life threatening or disabling; Grade 5 = Death.|Up to 2 years.||||percentage of subjects|||Number
2760611|NCT00802945|Secondary|Kaplan Meier Estimate of 1-year Survival|One year survival (i.e., overall survival proportion at 12 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.|From Cycle 1 Day 1 to the end of 12 months.||||percentage of subjects||95% Confidence Interval|Number
2760612|NCT00802945|Secondary|Kaplan Meier Estimate of 6-month Survival|Six-month survival (i.e., overall survival proportion at 6 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.|From Cycle 1 Day 1 to the end of 6 months.||||percentage of subjects||95% Confidence Interval|Number
2760613|NCT00802945|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|OS was calculated as the time from the date of first study drug administration until death from any cause. Subjects alive at the time of analysis were censored at the time they were last known alive. OS was analyzed for the ITT population.|Up to 2 years.||||Months||95% Confidence Interval|Median
2760614|NCT00802945|Secondary|Kaplan Meier Estimate of Progression-Free Survival (PFS)|"Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|Up to 2 years.||||Months||95% Confidence Interval|Median
2760615|NCT00802945|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years.||||percentage of subjects||95% Confidence Interval|Number
2760616|NCT00802919|Secondary|Change From Basellne in Calgary Depression Scale Score|The Calgary Depression Scale for Schizophrenia. The scale has 9 items with ratings of 0 to 3 on each item. Total score can vary from 0 to 27. Higher scores indicate more depression. Negative change scores indicate decreasing depression.|baseline, 4 weeks, 8 weeks|Not all patients had relevant responses on Calgary Depression Scale. Data are analyzed for 36 subjects randomized to varenicline and 38 subjects randomized to placebo (total N=74).|||Scores on a scale||Standard Error|Mean
2760617|NCT00802919|Secondary|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.|baseline, 4 weeks, 8 weeks||||units on a scale||Standard Error|Mean
2760618|NCT00802919|Primary|Change From Baseline in Cognitive Performance|The MATRICS Consensus Cognitive Battery (MCCB)(Measurement and Treatment Research to Improve Cognition in Schizophrenia) was used to measure cognitive performance. Six Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program (modified beta version) from raw scores on 10 individually administered subtests. The social cognition test was not assessed in this study. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.|basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)|N's varied from 25-32 in varenicline group and 29-35 in placebo group because all subjects did not complete all parts of MATRICS battery.Maximum number of participants is entered for number of participants because this cell entry does not allow entry of variable number of participations ( e.g. 25-32). for different scores..|||T scores from MATRICS battery||Standard Error|Mean
2760619|NCT00802919|Primary|Cotinine Level|plasma cotinine|Baseline, 4 weeks, 8 weeks|Data were available for cotinine analysis in mixed model analysis of co covariance on 34 participants in the varenicline arms and 36 participants in the placebo arm.|||cotinine ng/ml||Standard Error|Mean
2760620|NCT00802893|Secondary|Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness||4-8 weeks|Due to difficulties recruiting, this study was terminated and no data was collected.||||||
2760621|NCT00802893|Primary|Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function||4-6 weeks|Due to difficulties recruiting, this study was terminated and no data was collected.||||||
2760622|NCT00802880|Secondary|Correlate Overall Survival With Best Metabolic Response||Completion of follow-up (estimated to be 1 year)|28 patients were not evaluable for this outcome measure due to various reason such as progressive disease prior to cycle 3, unknown survival status, no target lesion on PET scan, and toxicity.|||months||95% Confidence Interval|Median
2760623|NCT00802880|Secondary|Correlate Overall Survival With Best Anatomic Response||Completion of follow-up (estimated to be 1 year)|26 patients were not evaluable for this outcome measure for various reasons including unknown survival status, progressive disease prior to cycle 3, no anatomic response noted, and toxicity.|||months||95% Confidence Interval|Median
2760626|NCT00802880|Secondary|Overall Survival||Until completion of follow-up or patient death (estimated to be 1 year)|One patient with invalid time or censoring value was not included.|||months||95% Confidence Interval|Median
2760627|NCT00802880|Secondary|Time to Progression (TTP)|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Until completion of follow-up (estimated to be 1 year)|10 patient observations with invalid time or censoring values were not included.|||months||95% Confidence Interval|Median
2760628|NCT00802880|Secondary|Overall Disease Control Rate||12 months|Only 6 patients were evaluable for response at the end of 12 cycles.|||participants|||Number
2760629|NCT00802880|Secondary|Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate||After completion of 3 cycles|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.|||participants|||Number
2760630|NCT00802880|Secondary|Overall Tumor Metabolic Response|"Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.~Partial metabolic response (PMR)~Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.~Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.~Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.~Progressive metabolic disease (PMD):~Unequivocal development of one more new metabolically active lesions~Target lesion: 20% or greater increase in maximum SUV from baseline.~Non-target lesions: unequivocal increase in FDG activity"|After completion of 3 cycles|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.|||participants|||Number
2760631|NCT00802880|Secondary|Comparison of the SUV at up to 3 Tumor Sites||Baseline and after every three cycles of treatment (up to 1 year)|The lower confidence limit is 85% and the upper confidence limit is 95%. 51 patients evaluable at baseline, 50 patients evaluable at end of cycle 3, 20 patients evaluable at end of cycle 6, 7 patients evaluable at end of cycle 9, and 5 patients evaluable at end of cycle 12.|||standard uptake value||95% Confidence Interval|Mean
2760632|NCT00802880|Secondary|Rate of Nausea/Emesis (Any Grade)|Approximately 18 weeks|Completion of 6 cycles of treatment (18 weeks)||||percentage of participants|||Number
2760633|NCT00802880|Secondary|Rate of Neutropenia (Grade 3/4)|"Grade 3 neutropenia = absolute neutrophil count of <1000 - 500/mm^3~Grade 4 neutropenia = absolute neutrophil count of <500/mm^3"|Completion of 6 cycles of treatment (18 weeks)||||percentage of participants|||Number
2760634|NCT00802880|Primary|Best Anatomical Tumor Response|"Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker~Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal~Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal~Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions"|After completion of 3 cycles|3 patients failed to complete 3 cycles of treatment due to toxicity. 22 patients failed to complete 3 cycles of treatment due to progressive disease. 1 patient only had PET scan.|||participants|||Number
2760635|NCT00802867|Primary|Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®|"Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.~Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash."|0 to 3 days post-dose 5 vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.|||Percentage of Participants|||Number
2760636|NCT00802867|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose||Pre-dose 5 and Day 28 to 48 Post-dose 5|The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.|||Titers||95% Confidence Interval|Geometric Mean
2760637|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose|Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination|Day 28 to 48 Post-dose 5|The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.|||Percentage of Participants|||Number
2760638|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose|Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.|Day 28 to 48 Post-dose 5|The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity.|||Percentage of participants|||Number
2760639|NCT00802867|Other Pre-specified|Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.|"Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).~Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer."|Day 28 to 48 Post-dose 5|The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.|||Percentage of Participants|||Number
2760648|NCT00802854|Primary|Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||Participants|||Count of Participants
2761519|NCT00795951|Primary|Diagnostic Performance: Black Rubber Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2760640|NCT00802854|Primary|Number of Participants With Overall Response (OR)|OR: final effectiveness evaluation analyzed using following criteria (based on physician's evaluation of CR & MR): a)Effective:clinical success (cure/improvement) & microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR & MR & neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist & CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.|||Participants|||Count of Participants
2760641|NCT00802854|Primary|Number of Participants With Mycological Response (MR)|In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.|||Participants|||Count of Participants
2760642|NCT00802854|Primary|Number of Participants With Clinical Response (CR)|CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.|||Participants|||Count of Participants
2760643|NCT00802854|Primary|Number of Participants With Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|"Safety analysis set included all participants who received at least 1 dose of Eraxis. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2760644|NCT00802854|Primary|Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)|AE=any untoward medical occurrence attributed to study drug in participant who received study drug. Treatment-emergent AE=AE between first dose of study drug up to 28 days after last dose that were absent before treatment/worsened relative to pretreatment state. Relatedness of AE to treatment assessed by physician as:Certain=clinically reasonable reaction on cessation of treatment;Probable/likely=followed reasonable time sequence from administration of treatment which was not explained by other drug/chemical substance/accompanying disease;Possible=followed reasonable time sequence from administration of treatment;Unlikely=not likely to have reasonable causal relationship with treatment, seems temporary;Conditional/unclassified=needed more data to make appropriate assessment/its additional data were being reviewed;Unaccessible/unclassifiable=lack of sufficient information hampered accurate causality assessment. % of AEs=(Number of AEs for specified categories/total number of AEs)*100.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||percentage of AEs|AEs||Number
2760645|NCT00802854|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes' (when AE was still present), 'unknown' (no information) or 'no, resolved' (when AE was not present and was resolved).|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Subset of safety analysis set which included all participants who had at least 1 AE.|||Participants|||Count of Participants
2760646|NCT00802854|Primary|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||events|||Number
2760647|NCT00802854|Primary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Subset of safety analysis set which included all participants who had at least 1 AE.|||days||Standard Deviation|Mean
2760649|NCT00802854|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||Participants|||Count of Participants
2760650|NCT00802841|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to the date of the death.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
2760651|NCT00802841|Secondary|Event-Free Survival (EFS)|EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
2760652|NCT00802841|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
2760653|NCT00802841|Secondary|Duration of CCyR|Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
2760654|NCT00802841|Secondary|Time to CCyR|Time to CCyR was defined as time from date of randomization to date of first documented CCyR.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
2760655|NCT00802841|Secondary|Percentage of Participants With CCyr|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Percentage of participants|||Number
2760656|NCT00802841|Secondary|Percentage of Participants With Major Molecular Response (MMR)|MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Percentage of participants|||Number
2760657|NCT00802841|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR)|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|6 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Percentage of participants|||Number
2760658|NCT00802737|Secondary|Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)|Cmax is defined as the maximum concentration of drug in plasma samples (collected at the end of the infusion). Ctrough is defined as the concentration of drug in plasma samples at the end of a dosing interval (collected directly before next administration). Ctrough before the first infusion represents residual ofatumumab from participation in Study Hx-CD20-406.|Visit 2 (Week 0) and Visit 14 (Month 4)|FAS. Data are provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Milligrams per liter (mg/L)||95% Confidence Interval|Geometric Mean
2760659|NCT00802737|Secondary|Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics|The data collected for this analysis are reported in the overall SAEs of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS||||||
2760660|NCT00802737|Secondary|Number of Participants With the Indicated Major Infections|The data collected for this analysis are reported in the overall Serious Adverse Events (SAEs) of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS||||||
2760661|NCT00802737|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS|||participants|||Number
2760662|NCT00802737|Secondary|Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab|HAHAs are indicators of immunogenicity to ofatumumab. HAHA levels were assessed for each participant at the end of participation in the study (at their last visit). A positive HAHA status indicates a positive enzyme-linked immunosorbent assay (ELISA) result, an inconclusive status indicates a negative ELISA result at ofatumumab concentration above the threshold at which ofatumumab may interfere with the assay, and a negative status indicates a negative ELISA result at ofatumumab concentration below the threshold.|Screening and post ofatumumab (up to Study Month 32)|"FAS. During the study, samples were to be taken at the last visit; however, this may not have been possible, such as in cases of death, or when the visit was not obvious as the last visit. Therefore, some samples were not available or were not collected."|||participants|||Number
2760663|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 24. Percent change was calculated as (Month 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 24|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 24. Only participants with a baseline value and a post-baseline value at Month 24 were included in the calculation.|||Percent change in tumor size||Full Range|Median
2760664|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 12. Percent change was calculated as (Month 12 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 12|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 12. Only participants with a baseline value and a post-baseline value at Month 12 were included in the calculation.|||Percent change in tumor size||Full Range|Median
2760665|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4|Reduction in tumor size was measured as the percent change in the sum of the products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24. Percent change was calculated as (Week 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 4|FAS. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 4. Only participants with a baseline value and a post-baseline value at Month 4 were included in the calculation.|||Percent change in tumor size||Full Range|Median
2760666|NCT00802737|Secondary|Overall Survival (OS)|OS is defined as the time from allocation to death.|Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)|FAS|||months||95% Confidence Interval|Median
2760667|NCT00802737|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)|FAS|||months||95% Confidence Interval|Median
2760668|NCT00802737|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression (prog.)/death. Prog. events are defined by well-documented and verifiable data; other data are censored. If the par. had prog. between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no prog. at the end of the trial, treatment discontinuation for undocumented prog./toxicity/other reason, new anti-cancer treatment, and death/prog. after >=2 missed visits in a row, the endpoint was censored. Clinical prog. is not considered as a prog. endpoint.|Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)|FAS|||months||95% Confidence Interval|Median
2760669|NCT00802737|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|From the time of the initial response until progression or death (average of 14.1 study months)|FAS|||months||95% Confidence Interval|Median
2760670|NCT00802737|Primary|Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits >=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, <30% lymphocytes (LC), no lymphoid nodule; PR: >=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0/Visit 2) until Week 52|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Some participants were not evaluable (NE) due to participant withdraw, refusal, non-trial drug-related adverse events, and death.|||participants|||Number
2760671|NCT00802685|Secondary|Number of Participants on Oxygen at 36 Weeks Postmenstrual Age||at 36 weeks postmenstrual age||||participants|||Number
2760672|NCT00802685|Primary|Days Spent on Supplemental Oxygen During the First 28 Days.||28 days of life|The number of participants for analysis was determined from all subjects who completed the study intervention at 28 days of age and had complete data on the primary endpoint of oxygen days during the first 28 days. Analysis was done on intention to treat basis.|||days||Full Range|Median
2760673|NCT00802672|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis|6 weeks|per protocol population|||participants|||Number
2760674|NCT00802672|Secondary|Proportion of Subjects With Mycological Cure|Mycological Cure (KOH wet mount negative and fungal culture negative|6 weeks|per protocol population|||participants|||Number
2760675|NCT00802672|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success|6 weeks|Per protocol population|||participants|||Number
2761520|NCT00795951|Primary|Diagnostic Performance: Carba Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2760676|NCT00802659|Secondary|Quality of Life|"As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)~Participant can chose on a scale of 0-4 with 0=not at all and 4=very much."|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
2760677|NCT00802659|Secondary|Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.||4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
2760678|NCT00802659|Secondary|Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.||4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
2760679|NCT00802659|Secondary|Duration of Pain Control for Each Dose Level.|A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
2760680|NCT00802659|Primary|Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field|"Optimal dose~the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications~the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first"|4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
2760681|NCT00802633|Secondary|Operating Room Time in Minutes||Intraoperative time||||minutes||Standard Deviation|Mean
2760682|NCT00802633|Primary|Estimated Blood Loss||Perioperative||||milliliters||Standard Deviation|Mean
2760683|NCT00802529|Secondary|Change in Speech Discrimination|"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score."|Baseline, 1,2,6,12 and 24months after initial treatment||||Percentage correct||Standard Deviation|Mean
2760684|NCT00802529|Secondary|Change in Hearing|Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.|Baseline, 1,2,6,12,18 and 24months after initial treatment||||dB||Standard Deviation|Mean
2760685|NCT00802529|Primary|Vertigo Attacks|The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).|6month pre-enrollment baseline, 18-24 months after initial treatment|Intention-to-treat|||Vertigo Attacks||Standard Deviation|Mean
2760686|NCT00802503|Secondary|Days in Hospital|hospital length of stay|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||days in hospital||95% Confidence Interval|Mean
2760687|NCT00802503|Secondary|Protein Delivery During the Intervention Period From Day 4 to Day 8|Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||percentage of protein target||Standard Deviation|Mean
2760688|NCT00802503|Secondary|ICU Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||participants|||Number
2760689|NCT00802503|Secondary|Days in ICU|Days in ICU|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||days in ICU||95% Confidence Interval|Mean
2760690|NCT00802503|Secondary|General Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||participants|||Number
2760691|NCT00802503|Secondary|Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.|Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||% of energy target||Standard Deviation|Mean
2760748|NCT00802100|Secondary|Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment||Measured over 28 weeks of study visits|Analysis population is those randomized. Outcome is discontinuation from study treatment before 28 weeks|||participants|||Number
2760692|NCT00802503|Secondary|Antibiotic Free Days|Number of days between day 9 to day 28 (follow-up period) free of antibiotics|20 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||number of days||95% Confidence Interval|Mean
2760693|NCT00802503|Secondary|Hours on Mechanical Ventilation in All Patients|Mechanical ventilation hours during study duration (days 1-28)|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||hours of mechanical ventilation||95% Confidence Interval|Mean
2760694|NCT00802503|Primary|Documented Infection Rate|Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28|20 days||||Infections|||Number
2760695|NCT00802464|Secondary|Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 3|The analyses were performed on the Month 3 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 3 study visit.|||Participants|||Count of Participants
2760696|NCT00802464|Secondary|Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 2|The analyses were performed on the Month 2 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 2 study visit.|||Participants|||Count of Participants
2760697|NCT00802464|Secondary|Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 0|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2760698|NCT00802464|Secondary|Number of Subjects With Suspected Cases of Herpes Zoster (HZ)|A suspected case of HZ is defined as a rash consistent with HZ.|During the period after Month 8 up to the end of the study at Month 14|The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.|||Participants|||Count of Participants
2760699|NCT00802464|Secondary|Number of Subjects With Suspected Cases of Herpes Zoster (HZ)|A suspected case of HZ was defined as a rash consistent with HZ.|From Month 0 until Month 8|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2760700|NCT00802464|Secondary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)|Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|During the period after Month 8 up to the end of the study at Month 14|The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.|||Participants|||Count of Participants
2760701|NCT00802464|Secondary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)|Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|From Month 0 until Month 8|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2760702|NCT00802464|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the period after Month 8 up to the end of the study at Month 14|The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.|||Participants|||Count of Participants
2760749|NCT00802100|Primary|Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study|Goal was to randomize 60 participants who met eligibility criteria.|Baseline|Total study population|||participants|||Number
2760703|NCT00802464|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 up to Month 8|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2760704|NCT00802464|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2760705|NCT00802464|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6)post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2760706|NCT00802464|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2760707|NCT00802464|Secondary|Anti-VZV Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2760708|NCT00802464|Secondary|Anti-gE Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2760709|NCT00802464|Secondary|Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||VZV-specific CD4+ T-cells/million T-cell||Standard Deviation|Mean
2760710|NCT00802464|Secondary|Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
2760711|NCT00802464|Primary|Anti-VZV Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2760712|NCT00802464|Primary|Anti-glycoprotein E (gE) Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2760713|NCT00802464|Primary|Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||VZV-specific CD4+ T-cells/million T-cell||Standard Deviation|Mean
2760714|NCT00802464|Primary|Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
2760715|NCT00802438|Secondary|Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab|IL-5 was measured via ELISA on bronchoalveolar lavage fluid before and after mepolizumab administration (up to 3 months of administration). Fluid was prepared in LowCross-Buffer to minimize potential matrix effects. A 1/2 dilution of 1X bronchoalveolar fluid was used for IL-5 detection. Data are expressed as pg/mL and are extrapolated to 1X.|before and after up to 3 months of Mepo|Participants had mild allergic asthma with a positive skin-prick test to house dust mite, ragweed, or a standardized extract of cat, a pre-180 4g albuterol FEV1 ≥70%, a post-albuterol FEV1 ≥ 80%; airway reversibility to albuterol (180 4g) ≥12% and/or airway hyper-reactivity to methacholine (PC20 ≤8 mg/ml).|||pg/ml||Inter-Quartile Range|Median
2760716|NCT00802438|Primary|The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).|Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge. This was done via differential cell count using Hema-3 stain. Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations. The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).|before and after up to 3 months of Mepo.|Participants had mild allergic asthma with a positive skin-prick test to house dust mite, ragweed, or a standardized extract of cat, a pre-180 4g albuterol FEV1 ≥70%, a post-albuterol FEV1 ≥ 80%; airway reversibility to albuterol (180 4g) ≥12% and/or airway hyper-reactivity to methacholine (PC20 ≤8 mg/ml).|||percent of bronchoalveolar eosinophils||Inter-Quartile Range|Median
2760717|NCT00802412|Secondary|Percent Relapsing to Any Drinking or Illicit Drug Use|Alcohol or illicit drug use during treatment or follow up.|12-week treatment phase, 36-week combined treatment and follow-up||||percentage of participants|||Number
2760718|NCT00802412|Primary|4-week Continuous Abstinence From Smoking|This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.|Weeks 8-12 of treatment.||||percentage of participants abstinent|||Number
2760719|NCT00802360|Secondary|Number of Live Births||Approximately 10 months|Database was locked prior to all participants giving birth.|||live births|||Number
2760720|NCT00802360|Secondary|Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable)~Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Day 1 - week 12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study|||participants|||Number
2760721|NCT00802360|Secondary|Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately week 7|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer|||participants|||Number
2760722|NCT00802360|Secondary|Participants With Biochemical Pregnancy at Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer|||participants|||Number
2760723|NCT00802360|Primary|Percentage of Participants With Ongoing Pregnancy at Week 8|The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.|Week 8 (Week 6 of gestation)|Intent to treat population|||percentage of participants|||Number
2760724|NCT00802360|Secondary|Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle|A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|Day 1 to Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||participants|||Number
2760725|NCT00802360|Secondary|Number of Embryos Frozen at Day 24|The number of embryos that were not transferred but instead were frozen for future use.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes fertilized|||embryos||Standard Deviation|Mean
2760804|NCT00801099|Primary|Number of Participants With Surgical Site Infections||within 30 days postoperative||||participants|||Number
2760726|NCT00802360|Secondary|Number of Embryos Transferred at Three Stages of Development|The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had embryos transferred.|||embryos||Standard Deviation|Mean
2760727|NCT00802360|Secondary|Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.|Approximately Day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.|||proportion of oocytes retrieved||Standard Deviation|Mean
2760728|NCT00802360|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.|Approximately Day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.|||oocytes||Standard Deviation|Mean
2760729|NCT00802360|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|Day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||follicles||Standard Deviation|Mean
2760730|NCT00802204|Secondary|Binge Eating Score Questionnaire|Increased scores indicate increased binge eating behaviors. Score 0-46|Baseline||||score from questionnaire||Standard Deviation|Mean
2760731|NCT00802204|Primary|Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)|Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method|Baseline to post 8-10days after VLCD|"9 lean enroll but only 8 complete. A ll lean complete study after baseline outcome measurements.~19 obese enroll but only 18 complete baseline studies and of these 15 completed the VLCD"|||10-4*min-1*microU-1*mL||Standard Deviation|Mean
2760732|NCT00802204|Primary|Acyl Ghrelin||Baseline to post 8-10days after VLCD||||pg/ml||Standard Deviation|Mean
2760733|NCT00802204|Primary|Leptin||Baseline to post 8-10days after VLCD||||ng/ml||Standard Deviation|Mean
2760734|NCT00802204|Primary|Glucose||Baseline to post 8-10days after VLCD||||mg/dL||Standard Deviation|Mean
2760735|NCT00802204|Primary|Insulin|microU/ml|Baseline to post 8-10days after VLCD||||microU/ml||Standard Deviation|Mean
2760736|NCT00802204|Primary|Striatal DRD2 Receptor Binding|Region of interest compared to reference region to calculate binding potential|Baseline and after 8-10days VLCD|Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD|||ratio||Standard Deviation|Mean
2760737|NCT00802178|Secondary|Global Clinical Assessments of Efficacy of Mirapexin® for All Patients|"Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor."|4 - 8 weeks|Treated set (TS)|||Number of Participants|||Number
2760738|NCT00802178|Secondary|Change From Baseline in UPDRS Part III|Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).|Baseline and 4 - 8 weeks|Full Analysis set (FAS)|||Unit on a scale|||Number
2760739|NCT00802178|Secondary|Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I|Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)|Baseline and 4 to 8 weeks|Full Analysis set (FAS)|||Unit on a scale|||Number
2760740|NCT00802178|Primary|Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated|"Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as good on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.~De-novo patients were identified by:~those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)"|4 - 8 weeks|Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated|||Participants|||Number
2760741|NCT00802113|Secondary|Total Number of Subjects That Experienced Transplant-related Mortality (TRM)|Status as subjects died post-AlloHCT|Up to 1 year post-transplantation||||participants|||Number
2760742|NCT00802113|Secondary|Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD)|The criteria for grading is based on extent of organ involvement (i.e., Skin, Liver and Gut - rash on >50% of skin, bilirubin 2-3 mg/dl, diarrhea > 500 ml/day) with Grade II being better outcome and Grade IV being worse outcome.|Up to 1 year post-transplantation|Subjects who completed RIC AlloHCT|||participants|||Number
2760743|NCT00802113|Secondary|Time to Platelet Engraftment|Following MAC AutoSCT, the median time to platelet recovery will be measured.|Up to 1 year post-transplantation|1 subject under Arm A and 2 subject under Arm B did not have this data point collected and therefore 3 subjects were not included into analysis.|||days||Full Range|Mean
2760744|NCT00802113|Secondary|Time to Neutrophil Engraftment|Following MAC AutoSCT, the median time to neutrophil (PMN) recovery will be measured.|Up to 1 year post-transplantation||||days||Full Range|Mean
2760745|NCT00802113|Primary|Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT|Total includes subjects with partial response and patients with stable disease, defined as <50% reduction in measurable disease or the uninterrupted persistence of B symptoms.|Up to 1 year post-transplantation||||Participants|||Count of Participants
2760746|NCT00802113|Primary|Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT|Includes subjects with any measurable growth of disease in a previously affected site or detection of disease in a new site confirmed by biopsy.|Up to 1 year post-transplantation||||Participants|||Count of Participants
2760747|NCT00802113|Primary|Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT)|Complete Response is defined as the complete resolution of B symptoms (i.e., weight loss, night sweats and fever) and normalization of all sites of disease on the basis of physical exam, bone marrow biopsy, and imaging studies.|Up to 1 year post-transplantation||||Participants|||Count of Participants
2760750|NCT00802074|Primary|CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||L/h||90% Confidence Interval|Mean
2760751|NCT00802074|Primary|AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng*h/mL||90% Confidence Interval|Mean
2760752|NCT00802074|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
2760753|NCT00802074|Primary|CL/F: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||L/h||90% Confidence Interval|Mean
2760754|NCT00802074|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare AE's for each sequence and not for each regimen. 3The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004)."|Day 0 through Day 49||||participants|||Number
2760755|NCT00802074|Primary|AUC: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
2760911|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N|Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760756|NCT00802074|Primary|Cmin/Cmax: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng/mL||90% Confidence Interval|Mean
2760757|NCT00801983|Primary|Musculoskeletal Discomfort|"Discomfort Survey (WDS) was used to assess symptoms and activity limitations. Participants reported on their work schedule, medication used for pain control, and discomfort in their neck/shoulder, back, and bilateral lower arms (elbows, forearms, wrists, and hands) using an 11-point numerical rating scale (0 = no discomfort/no limitations; 10 = unbearable discomfort/major limitations).~We had to dichotomize the data during analysis due to severe skew towards not discomfort (0). Thus the final outcome was discomfort -yes or no"|6 months and 12 months||||percentage of subjects with MSD|||Number
2760758|NCT00801931|Primary|Disease Free Survival (DFS)|DFS will be summarized using the Kaplan and Meier curves.|Up to 2 years|Not enough subjects were enrolled for data analysis.||||||
2760759|NCT00801931|Primary|Overall Survival (OS)|OS will be summarized using the Kaplan and Meier curves.|Up to 2 years|Not enough subjects were enrolled for data analysis.||||||
2760760|NCT00801931|Primary|Response Rate (Complete and Partial Response)|Response rate to each regimen will be measured.|Up to 2 years|Not enough subjects were enrolled for data analysis.||||||
2760761|NCT00801931|Primary|Graft Failure Rate|Number of patients to experience graft failure.|Up to 2 years|Not enough subjects were enrolled for data analysis.||||||
2760762|NCT00801892|Secondary|Fatigue/Inertia|Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia|after one month||||units on a scale||Standard Deviation|Mean
2760763|NCT00801892|Secondary|Change in Vigor-Activity During Main Study Period|Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity|after one month||||units on a scale||Standard Deviation|Mean
2760764|NCT00801892|Secondary|Change in Daytime Sleepiness During Main Study Period|Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness|after one month||||units on a scale||Standard Deviation|Mean
2760765|NCT00801892|Secondary|Change in Sleep Quality|From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period|after one month||||units on a scale||Standard Deviation|Mean
2760766|NCT00801892|Secondary|Fructosamine|Change in fructosamine level from baseline to one month: data from main study period|after one-month||||umol/L||Standard Deviation|Mean
2760767|NCT00801892|Primary|Physical Activity, Steps Walked|Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period|after one-month treatment||||steps walked||Standard Deviation|Mean
2760768|NCT00801827|Primary|Regional DRD2/3 Binding Percent Changes After Bariatric Surgery||~7 weeks||||percentage of binding potential change||Standard Deviation|Mean
2760769|NCT00801801|Secondary|Response Rate in Poor Performance Status Subjects|To assess response rate and tumor control rate (complete remission + partial remission + stable disease) in poor performance status (PS =2) patients with advanced or metastatic (Stage IIIB - pleural effusion/IV) non-squamous cell-NSCLC treated with metronomic chemotherapy plus sorafenib. The objective response was defined as a percentage of those patients that had 30% or more of tumor regression at any time during treatment. Tumor control rate include the percentage of those patients that have less than 20% increase in the target tumor parameters during treatment (stable disease + partial response + complete response).|6 months||||participants|||Number
2760770|NCT00801801|Primary|2-month Progression-free Survival Rate|Evaluation of the 2-month progression-free survival in poor performance status patients with non-squamous non-small cell lung cancer with the goal to improve 2-month progression free survival from 50% to 70%. The 2-month progression free survival is determined after 8 weeks on treatment. Those patients that had less than 20% increase in the tumor target lesions are considered as progression free survival. The primary endpoint is the percentage of patients that are progression free in 2 months.|Baseline to 2 months|As the study did not accrue the maximum sample size for statistical analysis, none were done.|||participants|||Number
2760771|NCT00801684|Secondary|Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP|Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.|up to 24 hours post-treatment|The PK population consisted of all subjects who received active study medication and had sufficient concentration data to facilitate calculation of the PK parameters or descriptive statistics of concentrations of trospium.|||Hours||Full Range|Median
2760772|NCT00801684|Secondary|FEV1 Response to Treatment|Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.|Up to 24 hours post-treatment|All 24 randomized subjects were included in the analysis.|||Participants|||Number
2760773|NCT00801684|Primary|Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose."|15 minutes to 24 hours post-treatment||||Liters||Standard Deviation|Mean
2760774|NCT00801632|Secondary|Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection|Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat|||Percentage of Participants||95% Confidence Interval|Number
2760775|NCT00801632|Secondary|Time to Platelet Recovery Following Transplant|Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat|||days||Standard Deviation|Mean
2760776|NCT00801632|Secondary|Time to Neutrophil Recovery Following Transplant|Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat|||days||Standard Deviation|Mean
2760777|NCT00801632|Secondary|Percentage of Participants Surviving Through 156 Weeks|The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced death prior to week 156|||Percentage of Participants||95% Confidence Interval|Number
2760778|NCT00801632|Secondary|Percentage of Participants With Graft Survival Through 156 Weeks|The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced graft loss prior to week 156|||Percentage of Participants||95% Confidence Interval|Number
2760779|NCT00801632|Secondary|Change in Renal Function|Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat|||mg/dL||Standard Deviation|Mean
2760780|NCT00801632|Secondary|Percentage of Participants Experiencing Acute Rejection|"The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat|||Percentage of Participants||95% Confidence Interval|Number
2760781|NCT00801632|Primary|Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks|A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.|48 months post-transplant|Intent-to-treat|||participants|||Number
2760782|NCT00801398|Secondary|Terminal Half-life of Single Dose of Oxymorphone by Treatment Group|t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)|Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||hour||Standard Deviation|Mean
2760783|NCT00801398|Secondary|Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group|λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)|Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||Time -1||Standard Deviation|Mean
2760784|NCT00801398|Secondary|Tmax of Single Dose of Oxymorphone by Treatment Group|Tmax: The time at which Cmax was observed|Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||hour||Standard Deviation|Mean
2760785|NCT00801398|Secondary|Cmax of Single Dose of Oxymorphone by Treatment Group|Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval|Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng/mL||Standard Deviation|Mean
2760786|NCT00801398|Secondary|AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group|AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration|Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng*hr/mL||Standard Deviation|Mean
2760787|NCT00801398|Secondary|AUC(0-t) of Single Dose of Oxymorphone by Treatment Group|AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule|Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h|PK Population (only including subjects with sufficient evaluable time points for this outcome measure).|||ng*hr/mL||Standard Deviation|Mean
2760788|NCT00801398|Primary|Subjects Taking Rescue Medication|Percentages are based on the number of subjects in each treatment group.|first dose through 48 hours after first dose|Safety Population|||Participants|||Count of Participants
2760789|NCT00801398|Primary|Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet|Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet|Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination|ITT Population|||mm||Standard Deviation|Mean
2760790|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.|Up to 3 x 31 months|Safety Analysis Set.|||participants|||Number
2760791|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.|Up to 3 x 31 months|Safety Analysis Set.|||participants|||Number
2760792|NCT00801242|Secondary|Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.|Up to 31 months|FAS, Cycle 1.|||units on a scale||Standard Deviation|Mean
2760793|NCT00801242|Secondary|Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Up to 31 months|FAS, Cycle 1|||units on a scale||Standard Deviation|Mean
2760794|NCT00801242|Secondary|Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.|||participants|||Number
2760795|NCT00801242|Secondary|Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1.|||days||95% Confidence Interval|Median
2760796|NCT00801242|Secondary|Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.|||percentage of baseline||Standard Deviation|Mean
2760797|NCT00801242|Primary|Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.|||days||95% Confidence Interval|Median
2760798|NCT00801229|Primary|"Participants Experiencing Collisions During Surprise Events in Driving Simulator"|"Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, surprise events, designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo."|6 weeks|Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total).|||participants|||Number
2760799|NCT00801138|Secondary|Total Three-day Opioid Consumption in Oral Oxycodone Equivalent||Postoperative day 1, 2 and 3||||milligrams||Inter-Quartile Range|Median
2760800|NCT00801138|Secondary|Median Maximum VAS Pain Scores at Rest|"Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicatesno pain at all and ten indicates worst pain imaginable. , The higher of the score, the worse of the pain."|Postoperative day 1, 2 and 3||||units on a scale||Inter-Quartile Range|Median
2760801|NCT00801138|Secondary|Time to First Report of Pain||Postoperative day 1, 2 and 3||||hours||Inter-Quartile Range|Median
2760802|NCT00801138|Primary|The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block||Postoperative day 1, 2 and 3||||hours||Inter-Quartile Range|Median
2760803|NCT00801099|Secondary|Sustainability of the Intervention in This Setting||during 3 month of study phase|||||||
2760805|NCT00800982|Primary|Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.|Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.|Weeks 12-24|All patients that completed the trial through week 24 were used for analysis.|||participants|||Number
2760806|NCT00800865|Primary|Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy|Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.|24, 32, and 48 hours post dose||||Ratio||90% Confidence Interval|Mean
2760807|NCT00800865|Primary|Level of Biomarkers|Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).|Baseline, 24, 32, and 48 hours post dose|Actual number of participants analyzed in Part I varied from 13 to 15, depending on time point. Actual number of participants analyzed in Part II was 16 for all time points.|||Percent pCDC2-positive cells||90% Confidence Interval|Geometric Mean
2760808|NCT00800839|Secondary|2-year Overall Survival|Overall Survival (OS) is defined as the interval between day of transplant and day of death.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
2760809|NCT00800839|Secondary|2-year Progression-Free Survival|Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
2760810|NCT00800839|Secondary|Rate of Engraftment|Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.|From engraftment to 60 days post transplant||||days||Full Range|Median
2760811|NCT00800839|Primary|Day-100 Treatment-Related Mortality|Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.|100 days post transplant||||percentage of participants||95% Confidence Interval|Number
2760812|NCT00800839|Primary|Cumulative Incidence of Grade III to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant||||percentage of incidence||95% Confidence Interval|Number
2760813|NCT00800839|Primary|Cumulative Incidence of Grade II to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant||||percentage of incidence||95% Confidence Interval|Number
2760814|NCT00800735|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event.|An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through 24 weeks after the end of treatment (up to 72 weeks)|All enrolled patients.|||Percentage of participants|||Number
2760815|NCT00800683|Secondary|Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|first administration of randomised treatment to ....|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG|||participants|||Number
2760816|NCT00800683|Secondary|Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time|Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.|Baseline and Week 52|Treated Set|||Participants|||Number
2760817|NCT00800683|Secondary|FPG Change From Baseline at week52|This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 52|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760818|NCT00800683|Secondary|FPG Change From Baseline at Week 48|This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 48|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760819|NCT00800683|Secondary|FPG Change From Baseline at Week 42|This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 42|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760820|NCT00800683|Secondary|FPG Change From Baseline at Week 36|This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 36|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760821|NCT00800683|Secondary|FPG Change From Baseline at Week 30|This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 30|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760822|NCT00800683|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760823|NCT00800683|Secondary|FPG Change From Baseline at Week 18|Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760824|NCT00800683|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
2760825|NCT00800683|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 52|The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).|Baseline and Week 52|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Percentage of patients|||Number
2760826|NCT00800683|Secondary|The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=7.0%. Non-completers were considered as failure imputation (NCF).|||Percentage of patients|||Number
2760827|NCT00800683|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=6.5%. Non-completers were considered as failure imputation (NCF).|||Percentage of patients|||Number
2760828|NCT00800683|Secondary|HbA1c Change From Baseline at Week 48|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 48|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760829|NCT00800683|Secondary|HbA1c Change From Baseline at Week 42|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 42|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760830|NCT00800683|Secondary|HbA1c Change From Baseline at Week 36|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 36|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760831|NCT00800683|Secondary|HbA1c Change From Baseline at Week 30|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 30|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760832|NCT00800683|Secondary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 24|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760833|NCT00800683|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 18|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760912|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N|Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760834|NCT00800683|Secondary|HbA1c Change From Baseline at Week 52|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 52|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760835|NCT00800683|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 12|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
2760836|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6|Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
2760837|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6|Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Median
2760838|NCT00800540|Secondary|Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6|End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
2760839|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks|Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
2760840|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6|Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
2760841|NCT00800540|Secondary|Mean Change From Baseline in Systolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)||Standard Error|Mean
2760842|NCT00800540|Secondary|Mean Change From Baseline in Diastolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)||Standard Error|Mean
2760843|NCT00800540|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6|Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
2760844|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||Arbitrary Units|Participants|Standard Error|Mean
2760845|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||Arbitrary Units|Participants|Standard Error|Mean
2760846|NCT00800540|Secondary|Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6|Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
2760847|NCT00800540|Primary|Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6|Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
2760848|NCT00800436|Secondary|Terminal Elimination Half-Life (T1/2) of Trastuzumab|T1/2 of trastuzumab was measured as the time required for trastuzumab concentration to decrease by one-half. T1/2 was derived across all PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population|||hours||Standard Deviation|Mean
2760849|NCT00800436|Secondary|Time to Maximum Serum Concentration (Tmax) of Trastuzumab|Tmax of trastuzumab was based on the Cmax derived across all post-dose PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population|||hours||Full Range|Median
2760850|NCT00800436|Secondary|Maximum Observed Serum Concentration of Trastuzumab (Cmax)|Cmax of trastuzumab was derived across all post-dose PK collections and expressed in μg/mL.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population|||μg/mL||Standard Deviation|Mean
2760851|NCT00800436|Secondary|Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab|CDay22 of trastuzumab was derived from the single PK collection on Day 22 and expressed in micrograms per milliliter (μg/mL).|Day 22|PK Population|||μg/mL||Standard Deviation|Mean
2760852|NCT00800436|Primary|Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab|AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).|Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population: All enrolled participants who adhered to the protocol (per protocol basis).|||days•μg/mL||Standard Deviation|Mean
2760853|NCT00800384|Secondary|Perioperative Complication Rate|A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.|30 days|Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.|||participants|||Number
2760854|NCT00800384|Primary|First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death|The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.|Mean follow-up of 3.1 years|All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.|||participants|||Number
2760855|NCT00800345|Secondary|Treatment Response|Treatment response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|After every 2 cycles of treatment beginning on Cycle 1 Day 1, up to 38 months||||participants|||Number
2760856|NCT00800345|Primary|Dose Limiting Toxicity (DLT)||Cycle 1 (28 days)||||participants|||Number
2760857|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
2760891|NCT00799773|Secondary|Relationship Between Clinical and Laboratory Data and Response to Treatment||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760858|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
2760859|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||meters||Standard Deviation|Mean
2760860|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
2760861|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
2760862|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||meters||Standard Deviation|Mean
2760863|NCT00800254|Secondary|Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 1 year|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||change in N-m/kg||Standard Deviation|Mean
2760864|NCT00800254|Primary|Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 3.5 weeks|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||change in N-m/kg||Standard Error|Mean
2760865|NCT00800202|Secondary|Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST|Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population|||percentage of participants||95% Confidence Interval|Number
2760866|NCT00800202|Secondary|Time to Death|Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method.|Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population; only participants with an event of death were included in the analysis.|||months||95% Confidence Interval|Median
2760867|NCT00800202|Secondary|Probability of Being Alive at 12 and 18 Months||Months 12 and 18|ITT Population|||percent||95% Confidence Interval|Number
2760868|NCT00800202|Secondary|Percentage of Participants Who Died||Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population|||percentage of participants|||Number
2760869|NCT00800202|Primary|Time to Disease Progression or Death|Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population; only participants with progression or death were included in the analysis.|||months||95% Confidence Interval|Median
2760870|NCT00800202|Primary|Percentage of Participants With Disease Progression or Death|Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population|||percentage of participants|||Number
2760871|NCT00800202|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|6 months|ITT Population|||percentage of participants||95% Confidence Interval|Number
2760872|NCT00799903|Secondary|Number of Participants With All-cause Mortality During the Time Period for Vital Status|The number of participants with all-cause mortality was assessed.|From randomization until death or study completion (up to 4.49 years/average of 3.65 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760873|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760874|NCT00799903|Secondary|Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events|Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760875|NCT00799903|Secondary|Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760876|NCT00799903|Secondary|Number of Participants With CV Death During the Time Period for Follow-up of CV Events|CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760877|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events|CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760878|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events|CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
2760908|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)|Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760879|NCT00799903|Primary|Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events|CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All-randomized Intent-to-treat (ITT) population comprised of all randomized participants.|||Participants|||Count of Participants
2760880|NCT00799825|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes.||Throughout the study (up to Month 12)|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.|||Subjects|||Number
2760881|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.|||Subjects|||Number
2760882|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.|||Subjects|||Number
2760883|NCT00799773|Secondary|B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760884|NCT00799773|Secondary|Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760885|NCT00799773|Secondary|Effect of Plasma Exchange on Rituximab Levels||Measured at Month 6|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760886|NCT00799773|Secondary|Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760887|NCT00799773|Secondary|Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760888|NCT00799773|Secondary|Treatment-related Complications||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760889|NCT00799773|Secondary|All Cause Mortality||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760890|NCT00799773|Secondary|Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760892|NCT00799773|Secondary|Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760893|NCT00799773|Secondary|Use of Non-study Treatment||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760894|NCT00799773|Primary|Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
2760895|NCT00799708|Secondary|Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.|Change from baseline in unstimulated labial gland saliva flow rate at Day 7|Baseline and Day 7|All subjects with salivary flow rate measured at baseline and 7 days|||μL/min||90% Confidence Interval|Least Squares Mean
2760896|NCT00799708|Primary|Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7|Subset of genes on the log ratio intensity scale from a microarray platform - signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens- quantified as a ratio of up regulated versus down regulated genes|Baseline and Day 7|All subjects with salivary gland tissue with RNA of acceptable quality based on pre-specified QC criteria|||Fold change||Standard Error|Least Squares Mean
2760897|NCT00799643|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy||24 and 48 weeks|||||||
2760898|NCT00799643|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication||24 and 48 weeks|||||||
2760899|NCT00799643|Secondary|Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers||24 and 48 weeks|||||||
2760900|NCT00799643|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)||48 weeks|||||||
2760901|NCT00799643|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%||24 and 48 weeks|||||||
2760902|NCT00799643|Secondary|Change From Baseline in Fasting Glucose Over Time.||48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks|||mg/dl||95% Confidence Interval|Mean
2760903|NCT00799643|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.|HbA1c (%, percentage of HbA1c) change from baseline.|48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks|||HbA1c units are %||95% Confidence Interval|Mean
2760904|NCT00799617|Secondary|Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)|"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 gm/dL from baseline.~Values are means (SDs) for continuous outcomes."|1 year (baseline to month 12)||||proportion of participants||Standard Deviation|Mean
2760905|NCT00799617|Secondary|Cognitive Function Trial - Executive Function - Trail Making Test B - A|"Baseline score and change in score in Executive Function as Measured by Trail-Making Test (TMT) B - A, at baseline, Month 6 and Month 12.~Change in performance on the Trail Making Test was analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version.~Participants are required to connect a set of numbers (Part A) or alternating letters and numbers (Part B) in sequential order. The score for each part is the total time (in seconds) to complete both parts. The outcome analyzed will be the total time for Trails B minus the total time for Trails A to provide a measure of working memory, adjusted for attention and processing speed. Higher scores reflect lower executive function."|1 year (baseline to month 6 to month 12)||||Score on the Trail Making Test scale||95% Confidence Interval|Mean
2760906|NCT00799617|Secondary|Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)|"Baseline score and change in score in the Spatial Ability Using the Card Rotation Test at baseline, Month 6 and Month 12.~Change in performance on the Card Rotations Test will be analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version. The test consists of a series of 10 primary figures, each of which has 8 corresponding secondary figures. Subjects are asked to determine which of the secondary figures is the same as the corresponding primary figure, and the score is taken as the number of figures answered correctly minus the number of figures answered incorrectly.~The maximum score is 80 for subjects who answer all items correctly."|1 year (baseline to month 6 to month 12)||||Score on the CRT test scale||95% Confidence Interval|Mean
2760907|NCT00799617|Secondary|Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)|"Baseline score and mean change in score in the Visual Memory Using the Benton Visual Retention Test (BVRT) from baseline, Month 6 and Month 12.~The BVRT measures short term visual memory and visuo-constructional abilities and was administered and scored according to standard procedures. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score was the total number of figures with errors and ranged from 0 to 26. Scores were inverted to 0 to -26 so that higher scores would reflect better performance.~Change in BVRT scores from baseline are treated as continuous and compared between AAMI Androgel and placebo subjects using linear random effects models adjusting for balancing factors as described in the primary analysis."|1 year (baseline to month 6 and month 12)||||Score on the BVRT test scale||95% Confidence Interval|Mean
2760913|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N|Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760914|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N|Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760915|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N|Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760916|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N|Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760917|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)|Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760918|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)|Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760919|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)|Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760920|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)|Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760921|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)|Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
2760922|NCT00799617|Secondary|Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline|Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis).|1 year (change from baseline to month 12)|All participants with measurements of both baseline and 12-month assessments were included in the analysis.|||Agatston units||95% Confidence Interval|Least Squares Mean
2760923|NCT00799617|Secondary|Cardiovascular Trial - Total Plaque Volume Change From Baseline|Total plaque volume,mm3 measured by coronary computed tomographic angiography|1 year (change from baseline to month 12)||||mm^3||95% Confidence Interval|Mean
2760924|NCT00799617|Secondary|Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score|"Baseline score and change in score in the Patient Health Questionnaire 9 (PHQ-9) from baseline to Month 12.~Scores on the Patient Health Questionnaire 9 (PHQ-9) depression scale range from 0 to 27, with higher scores indicating greater intensity of depressive symptoms."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PHQ-9 test scale||Standard Deviation|Mean
2760925|NCT00799617|Secondary|Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12|"Baseline score and change in the total negative affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.~Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PANAS test scale||Standard Deviation|Mean
2760926|NCT00799617|Secondary|Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.|"Baseline score and change in the total positive affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.~Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PANAS test scale||Standard Deviation|Mean
2760927|NCT00799617|Secondary|Vitality Trial - SF-36 Score|Baseline score and change in the SF-36 Vitality Score from baseline to Month 12 Scores on the vitality scale of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating less fatigue.|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the SF-36 vitality scale||Standard Deviation|Mean
2760928|NCT00799617|Secondary|Vitality Trial - FACIT Fatigue Overall Score|Baseline score and change in the FACIT- Fatigue score from baseline to Month 12. Scores on the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the FACIT- Fatigue test scale||Standard Deviation|Mean
2760929|NCT00799617|Secondary|Physical Function Trial - PF 10 Overall Score|"Baseline score and the change in score on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short Form Health Survey range from 0 to 100, with higher scores indicating better function.~Scores were measured as the change from baseline to Month 12."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PF-10 test scale||Standard Deviation|Mean
2760930|NCT00799617|Secondary|Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)|The number of participants whose score on the physical-function domain (PF-10; range, 0 to 100, with higher scores indicating better function) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) increased by at least 8 points from baseline to Month 12.|1 year (change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.|||Participants|||Count of Participants
2760931|NCT00799617|Secondary|Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters|Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12|1 year (change from baseline to month 3, 6, 9 and 12)||||meters||Standard Deviation|Mean
2760932|NCT00799617|Secondary|Sexual Function Trial - Erectile Function|"Baseline score and the change in score on the International Index of Erectile Function (IIEF) from baseline to Month 12.~Scores on the IIEF range from 0-30, with higher scores indicating better function."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the IIEF test scale||Standard Deviation|Mean
2760933|NCT00799617|Secondary|Sexual Function Trial - Sexual Desire Domain|"Baseline score and the changes in the score of the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II), from baseline to Month 12.~Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the DISF-M-II scale||Standard Deviation|Mean
2760934|NCT00799617|Primary|Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia|"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline.~Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline."|1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)|Unexplained anemia is anemia that is not due to the following causes: iron and vitamin B12 deficiency, chronic inflammation and disease, chronic renal insufficiency, myelodysplastic syndromes.|||Participants|||Count of Participants
2760935|NCT00799617|Primary|Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)|"Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12.~The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR."|1 year (change from baseline to month 6 and month 12)|Men, age 65 years or older with low testosterone and Age-Associated Memory Impairment (AAMI)|||percentage of change in test score||95% Confidence Interval|Mean
2760936|NCT00799617|Primary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone|Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12|1 year (QCT measurement of BMD change between baseline and month 12)||||mg/cm^3||95% Confidence Interval|Mean
2760937|NCT00799617|Primary|Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume|Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12|1 year (change in plaque volume measurement from baseline to month 12)|Men aged 65 years or > with an average of 2 serum testosterone levels lower than 275 ng/L and enrolled in the CV Trial of the Testosterone Trials between June 2010 and June 2014.|||mm^3||95% Confidence Interval|Mean
2760938|NCT00799617|Primary|Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)|"The number of participants whose score on the FACIT-Fatigue scale increased by at least 4 points.~Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue."|1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.|||Participants|||Count of Participants
2760939|NCT00799617|Primary|Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)|The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.|1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.|||Participants|||Count of Participants
2760940|NCT00799617|Primary|Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12|"Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12.~Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.~The change is measured form the baseline value to Month 12."|1 year (change from baseline to month 3, 6, 9 and 12)||||units on the PDQ-Q4 scale||Standard Deviation|Mean
2760941|NCT00799604|Primary|The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.|||percent change||Standard Deviation|Mean
2760942|NCT00799604|Secondary|Change in Heart Rate After Bolus 1 (Pre-anesthesia).|The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1.|Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia).|Safety population: all enrolled patients (irrespective of eligibility) who are dosed with clevidipine. The safety population will be the primary population used for the safety analyses.|||beats per minute (bpm)||Standard Deviation|Mean
2761521|NCT00795951|Primary|Diagnostic Performance: Epoxy Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2760943|NCT00799604|Secondary|The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change).|Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||minutes||95% Confidence Interval|Median
2760944|NCT00799604|Secondary|The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||percent change||Standard Deviation|Mean
2760945|NCT00799604|Secondary|The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||minutes||95% Confidence Interval|Median
2760946|NCT00799604|Secondary|The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||percent patients||95% Confidence Interval|Number
2760947|NCT00799604|Primary|The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.|||mm Hg||Standard Deviation|Mean
2760948|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination|Microbiological sampling results categorized according to direct examination (identification of the class of germs).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation; participants may be represented in >1 category.|||percentage of participants|||Number
2760949|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture|Microbiological sampling results categorized as a positive blood culture (presence of infection).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation.|||percentage of participants|||Number
2760950|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.|||percentage of participants|||Number
2760951|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.|||percentage of participants|||Number
2760952|NCT00799591|Secondary|Mean Duration (Days) of Treatment With Tigecycline||Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population|||days||Standard Deviation|Mean
2760983|NCT00799474|Secondary|Awareness of HPV Vaccine|"Measured if participants had heard of HPV vaccine prior to survey. Participants were asked if they had heard to HPV vaccine prior to the survey and had response options of yes, no, and I don't know."|At time of interview||||Participants|||Number
2760953|NCT00799591|Secondary|Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose|Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.|Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population|||percentage of participants|||Number
2760954|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants with analyzable data at observation.|||percentage of participants||95% Confidence Interval|Number
2760955|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|End of Treatment (on the day of last dose of study treatment) or up to 25 months|Intent-to-Treat (ITT): all participants included in the study who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2760956|NCT00799578|Primary|Normalization or >50% of Serum ALT Levels From Baseline||6 months||||participants|||Number
2760957|NCT00799487|Secondary|Hour 8.75 Packet Activity - Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760958|NCT00799487|Secondary|Hour 8.75 Packet Activity - Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760959|NCT00799487|Secondary|Hour 8.75 Packet Activity - Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760960|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760982|NCT00799474|Secondary|Knowledge of HPV|Assessed participants' knowledge of HPV by summing correct responses to nine HPV knowledge items. Questions addressed what diseases are associated with HPV, how HPV is transmitted, and how common HPV infection is. For each item, participants were classified as having answered the item correctly or incorrectly.|At time of interview|HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430)|||Correct Responses||Standard Deviation|Mean
2760961|NCT00799487|Secondary|Hour 8.75 Packet Activity - Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760962|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identiy Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760963|NCT00799487|Secondary|Hour 8.75 Packet Activity - Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order)(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760964|NCT00799487|Secondary|Hour 3.0 Grammar Task|"This task, presented once during a laboratory school day, was designed to index attention to detail by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors (range: 0, 1 represents correct responses divided by the number of possible responses)."|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760965|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Number of targets missed. Higher score is preferable (observed range: -419.4, 108.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Targets missed||Standard Deviation|Mean
2760966|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
2760967|NCT00799487|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (observed range: 0, 212), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. Children read 3 stories and completed the forms. A higher score was preferable and indicated a greater number of words read correctly in the time allowed|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760968|NCT00799487|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)|The THS-R is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes the 10 subtests: writing from memory the upper- and lower-case letters of the alphabet in order, writing from dictation the upper and lower-case letters of the alphabet out of order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). A higher score was preferable (observed range: 0, 118).|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760969|NCT00799487|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT)|Gray Silent Reading Test (GSRT) is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (observed range: 0, 141). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760970|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
2760971|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Responses to non-targets. Higher score is preferable (observed range: -82.4, 128.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Responses to non-targets||Standard Deviation|Mean
2760972|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
2760973|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
2760974|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. SD of response times (msecs) (observed range: -177.6, 132.9). Higher score indicates less variability.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||milliseconds||Standard Deviation|Mean
2760975|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Mean response latency in msecs (observed range: -75.4, 129.5). Higher score indicates faster reaction time.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Milliseconds (msecs)||Standard Deviation|Mean
2760976|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target (observed range: -15.2, 5.2). An ADHD score of less than -1.80 is suggestive of ADHD.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760977|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of child impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760978|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760979|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0,36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher's directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
2760980|NCT00799487|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Problems correct||Standard Deviation|Mean
2760981|NCT00799487|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable.)|Hour 4 of the Double-Blind Assessment Period Lab School Day|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Problems attempted||Standard Deviation|Mean
2760984|NCT00799474|Primary|Willingness to Receive the Human Papillomavirus (HPV) Vaccine|"Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from definitely not willing to definitely willing was used to meausure willingness."|at time of interview|One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608|||Participants|||Number
2760985|NCT00799435|Secondary|Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide||Measured at Week 12|||||||
2760986|NCT00799435|Primary|Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity||Measured at Week 12|||||||
2760987|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week|Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.|||mm||Standard Deviation|Mean
2760988|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week|Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.|||mm||Standard Deviation|Mean
2760989|NCT00799422|Primary|Mean Circumlimbal Conjunctival Staining Score|Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.|1 week|This reporting group includes all participants who completed all study visits.|||Units on a scale||Standard Deviation|Mean
2760990|NCT00799409|Secondary|Hour 8.75 Packet Activity Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760991|NCT00799409|Secondary|Hour 8.75 Packet Activity Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760992|NCT00799409|Secondary|Hour 8.75 Packet Activity Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760993|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760994|NCT00799409|Secondary|Hour 8.75 Packet Activity Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760995|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760996|NCT00799409|Secondary|Hour 8.75 Packet Activity Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760997|NCT00799409|Secondary|Hour 3.0 Grammar Task|"This task, presented once during a laboratory school day, was designed to index attention to detail by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses)."|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760998|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2760999|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Trials||Standard Deviation|Mean
2761000|NCT00799409|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761001|NCT00799409|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score|The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761002|NCT00799409|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient|Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761003|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Trials||Standard Deviation|Mean
2761004|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761005|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Sequences||Standard Deviation|Mean
2761006|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Sequences||Standard Deviation|Mean
2761007|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761008|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761009|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761010|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761011|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761012|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher's directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
2761013|NCT00799409|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Problems correct||Standard Deviation|Mean
2761014|NCT00799409|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)|Hour 4 of the of the Lab School Day during Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point. Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/CONCERTA (lab day 1/lab day 2) plus the 35 children randomized to CONCERTA/Placebo|||Problems attempted||Standard Deviation|Mean
2761015|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel Plus Aspirin|Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation|Measured at baseline, and after clopidogrel plus aspirin treatment||||percentage of max aggregation change||Standard Deviation|Mean
2761016|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel|Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.|Measured at baseline, and after clopidogrel treatment||||percentage of maximum aggregation change||Standard Deviation|Mean
2761017|NCT00799383|Secondary|Polar Section Modulus|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm^3||Standard Deviation|Mean
2761018|NCT00799383|Secondary|Endosteal Circumference|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm||Standard Deviation|Mean
2761019|NCT00799383|Secondary|Periosteal Circumference|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm||Standard Deviation|Mean
2761020|NCT00799383|Secondary|Cortical Thickness|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm||Standard Deviation|Mean
2761021|NCT00799383|Secondary|Cortical Bone Mineral Density|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mg/cm^3||Standard Deviation|Mean
2761022|NCT00799383|Secondary|Bone Strength Index, mg2/mm4|Measured at the 4% radius site.|36 weeks|Sample size is smaller because scans with movement artifact were removed at baseline. At follow up, attrition also contributed.|||mg^2/mm^4||Standard Deviation|Mean
2761023|NCT00799383|Primary|Total Body Bone Mineral Content|Outcomes were measured at baseline, 18 weeks, and 36 weeks later.|36 weeks|Numbers below reflect attrition.|||Z score (age-sex-height-race specific)||Standard Deviation|Mean
2761024|NCT00799383|Primary|Trabecular Bone Mineral Density in the Ultradistal Radius|"Peripheral quantitative computed tomography (pQCT) scan was obtained at the 4% and 20% sites of the nondominant radius to estimate trabecular and cortical BMD, respectively. A Stratec XCT-2000 scanner, software version 6.0 (Stratec, Inc., Pforzheim, Germany),was used. Trabecular BMD was measured as the mean density of the 85% central area of the bone's cross-section.~Outcomes were measured at baseline, 18 weeks, and 36 weeks later."|36 weeks|The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded. At late time points, the sample size reflects both attrition and exclusion due to movement artifact.|||mg/cm^3||Standard Deviation|Mean
2761025|NCT00799292|Primary|Estimated Blood Loss|Estimated blood loss as mL|Duration of vaginal hysterectomy||||mL||Standard Deviation|Mean
2761026|NCT00799292|Secondary|Operative Time and Complication Rates||Duration of procedures and immediate post-operative stay in hospital|||||||
2761027|NCT00799292|Primary|Intra-operative Blood Loss During Vaginal Hysterectomy||Blood loss will be assessed at the end of the operative procedure|||||||
2761028|NCT00799266|Secondary|Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that zoledronic acid is safe for the treatment of osteoporotic children treated with glucocorticoids through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis done.|Baseline through Month 12|The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug, was considered.|||Percentage of Participants|||Number
2761029|NCT00799266|Secondary|Urinary Concentration of Zoledronic Acid at Month 12|Urine was collected overnight or for at least 4 waking hours from all patients able to provide specimens, to measure urinary concentration of zoledronic acid at Month 12. Only descriptive analysis done.|Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||ng/mL||Standard Deviation|Mean
2761030|NCT00799266|Secondary|Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12|Left posteroanterior (PA) hand/wrist X-ray were taken at Visit 1 and at the Month 12 visit to assess bone age and the between-treatment differences for change in 2nd metacarpal cortical width at Month 12 relative to baseline. If a fracture of the left upper extremity precluded radiographic imaging, then the right hand was evaluated for this purpose. In this case, the right hand was be imaged at both Visit 1 and at Month 12. The information was used in the assessment of bone density.|Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||millimeter (mm)||Standard Error|Least Squares Mean
2761043|NCT00799227|Secondary|Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to treat: all enrolled patients|||Percentage of Patients|||Number
2761031|NCT00799266|Secondary|Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12|Pain was evaluated at each visit (in office and telephone visit) at randomization, Months 3, 6, 9 and 12 using the Faces Pain Scale-Revised (FPS-R). Children were selecting the face that best fits their pain. The pain score ranged from 0 (No Pain) to 10 (Very Much Pain). The reduction in pain from baseline by visit was evaluated based on whether or not patients had a decrease in their FPS-R from baseline. If pain remained the same or worsened from baseline a patient was classified as '0' and if the pain scale decreased then the patient was classified as '1'.|Month 3, Month 6, Month 9 and Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||Percentage of Patients|||Number
2761032|NCT00799266|Secondary|Mean Change From Baseline in Vertebral Morphometry at Month 12|Vertebral morphometry (or concave index) was calculated using the average ratio between mid-height and posterior height from L1 to L4 and performed by a central reader.|Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||Ratio||Standard Error|Least Squares Mean
2761033|NCT00799266|Secondary|Number of Participants With New Vertebral Fractures at Month 12|New vertebral fractures were defined as fractures of Genant Grade 1 or higher that occurred at lumbar or thoracic spine from first dose infusion to the end of the study.|Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||Participants|||Count of Participants
2761034|NCT00799266|Secondary|Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12|Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.|Month 6, Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||U/L||Standard Error|Least Squares Mean
2761035|NCT00799266|Secondary|Mean Change From Baseline in Serum NTX at Months 6 and 12|Serum Cross linked N-telopeptide (NTX) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.|Month 6, Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||nmol BCE/L||Standard Error|Least Squares Mean
2761036|NCT00799266|Secondary|Mean Change From Baseline in BSAP at Months 6 and 12|Bone specific alkaline phosphatase (BSAP) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.|Month 6, Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||nanogram per milliliter (ng/mL)||Standard Error|Least Squares Mean
2761037|NCT00799266|Secondary|Mean Change From Baseline in Serum P1NP at Months 6 and 12|Serum Procollagen type 1 amino-terminal propeptide (P1NP) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.|Month 6, Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||nanogram per milliliter (ng/mL)||Standard Error|Least Squares Mean
2761038|NCT00799266|Secondary|Mean Change From Baseline in Total Body BMC at Month 6 and 12|Total body BMC was all determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.|Month 6, Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||g||Standard Error|Least Squares Mean
2761039|NCT00799266|Secondary|Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12|Lumbar Spine BMC was determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.|Month 6, Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||g||Standard Error|Least Squares Mean
2761040|NCT00799266|Secondary|Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6|Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 6. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.|Month 6|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||Z-score||Standard Error|Least Squares Mean
2761041|NCT00799266|Primary|Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12|Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 12. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.|Month 12|The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.|||Z-score||Standard Error|Least Squares Mean
2761042|NCT00799227|Secondary|Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye|Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).|Baseline, Week 26|Intent to Treat: all enrolled patients|||Percentage of Patients|||Number
2761044|NCT00799227|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients|||Letters Read Correctly||Standard Deviation|Mean
2761045|NCT00799227|Primary|Change From Baseline in Central Retinal Thickness in the Study Eye|Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients|||Microns||Standard Deviation|Mean
2761046|NCT00798967|Secondary|Absolute Change in PN/I.V. Volume From Baseline to Last Time Point|Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).|Week 0 to last visit when data was collected.|Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients.|||Liters/Week||Standard Deviation|Mean
2761047|NCT00798967|Primary|Responder|Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.|Weeks 20 and 24|Percentages were based on the number of subjects in the Intent to Treat (ITT) population.|||subjects|||Number
2761048|NCT00798889|Primary|Duration of Treatment||Baseline up to Day 28 after last dose of study treatment|The intent-to-treat population included all participants who were enrolled in the study and received at least 1 dose of study medication.|||Days||Full Range|Median
2761049|NCT00798759|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.|||Units on a scale||Standard Error|Mean
2761050|NCT00798759|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.|||Seconds||Standard Error|Mean
2761051|NCT00798720|Secondary|Toxicity|Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|30 days post-treatment||||participants|||Number
2761052|NCT00798720|Secondary|Median Overall Survival||5 years||||months||95% Confidence Interval|Median
2761053|NCT00798720|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Until disease progression, up to 2 years||||participants|||Number
2761054|NCT00798720|Primary|Three-month Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Three-months post-treatment||||percentage of participants||95% Confidence Interval|Number
2761055|NCT00798707|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2761056|NCT00798707|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|"C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of Yes on Actual Attempt),preparatory acts toward imminent suicidal behavior (3)(Yes on Preparatory Acts or Behavior),suicidal ideation (4)(Yes on Wish to be dead,Non-Specific Active Suicidal Thoughts,Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(Yes on Has subject engaged in Non-suicidal Self-Injurious Behavior)."|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Participants|||Number
2761080|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 neuropathy data.|||units on a scale||Full Range|Median
2761057|NCT00798707|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Percentage of Participants|||Number
2761058|NCT00798707|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2761059|NCT00798707|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Error|Mean
2761060|NCT00798707|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.|||nanogram(ng)/mL||Standard Deviation|Mean
2761061|NCT00798707|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2761062|NCT00798707|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2761063|NCT00798707|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2761064|NCT00798707|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2761065|NCT00798707|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit,LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2761522|NCT00795951|Primary|Diagnostic Performance: P-tert Butylphenol Formadehyde Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761066|NCT00798707|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2761067|NCT00798707|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
2761068|NCT00798707|Secondary|Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2761069|NCT00798707|Primary|Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.|||Units on a scale||Standard Error|Mean
2761070|NCT00798694|Secondary|Corneal Staining Score|Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).|Baseline, 1 month, 2 months|One eye from each patient per arm.|||scores on a scale||Standard Deviation|Mean
2761071|NCT00798694|Secondary|Ocular Surface Disease Index Score|Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time.|Baseline, 1 month, 2 months||||scores on a scale||Standard Deviation|Mean
2761072|NCT00798694|Secondary|Intraocular Pressure|Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.|Baseline, 1 month, 2 months||||mmHg||Standard Deviation|Mean
2761073|NCT00798694|Secondary|Conjunctival Hyperemia Score|Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).|Baseline, 1 month, 2 months|One eye per participant in each Arm|||units on a scale||Standard Deviation|Mean
2761074|NCT00798694|Secondary|Tear Production|Tear production, measured by Schirmer test in millimeters|Baseline, 1 month, 2 months||||millimeters||Standard Deviation|Mean
2761075|NCT00798694|Primary|Change in Tear Break up Time (TBUT)|Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.|Baseline, 1 month, 2 months|Both eyes combined change from baseline.|||seconds||Standard Deviation|Mean
2761076|NCT00798655|Secondary|Probability of 2-year Overall Survival||Up to 90 months for cohort; individual patients up to 24 months|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.|||percentage of participants||95% Confidence Interval|Number
2761077|NCT00798655|Primary|Probability of Progression-free Survival (PFS) at 2 Years||Up to 90 months for cohort; individual patients up to 24 months after study treatment|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.|||percentage of participants||95% Confidence Interval|Number
2761078|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 nausea data.|||units on a scale||Full Range|Median
2761079|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 nausea data.|||units on a scale||Full Range|Median
2761081|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 neuropathy data.|||units on a scale||Full Range|Median
2761082|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 fatigue data.|||units on a scale||Full Range|Median
2761083|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 fatigue data.|||units on a scale||Full Range|Median
2761084|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LASA data.|||units on a scale||Full Range|Median
2761085|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LASA data.|||units on a scale||Full Range|Median
2761086|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LCSS data.|||units on a scale||Full Range|Median
2761087|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LCSS data.|||units on a scale||Full Range|Median
2761088|NCT00798603|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.|||months||95% Confidence Interval|Median
2761089|NCT00798603|Secondary|Progression-free Survival|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.|||months||95% Confidence Interval|Median
2761090|NCT00798603|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.|||months||95% Confidence Interval|Median
2761091|NCT00798603|Secondary|Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Up to 2.5 years|All participants who received treatment.|||particpants|||Number
2761092|NCT00798603|Secondary|Duration of Response|Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response.|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.|||months||95% Confidence Interval|Median
2761523|NCT00795951|Primary|Diagnostic Performance: Cobalt Dichloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761093|NCT00798603|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.~Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions."|Duration of study until progression (up to 5 years)|All participants who met the eligibility criteria, have started the study treatment and have post-baseline disease assessments.|||percentage of participants||95% Confidence Interval|Number
2761094|NCT00798603|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.|6 months|The first 55 participants who met the eligibility criteria and have started the study treatment.|||percentage of participants||95% Confidence Interval|Number
2761095|NCT00798590|Secondary|Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.||||||
2761096|NCT00798590|Primary|To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.||||||
2761097|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose|No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.|||Percent bacteria eradicated|||Number
2761098|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hour after administration of first dose|No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1|||Percent bacteria eradicated|||Number
2761099|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose||||Percent bacteria eradicated|||Number
2761100|NCT00798577|Secondary|Exploratory Evaluation of Changes in Ocular Signs and Symptoms|"Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis:~Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale."|Baseline (Day 1) to Day 2||||Participants|||Number
2761101|NCT00798577|Primary|Exploratory Outcomes From Digital Photography|Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.|24 hours after administration of first dose||||Participants|||Number
2761102|NCT00798486|Secondary|Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit|Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).|One hour||||number of participants|||Number
2761103|NCT00798486|Secondary|Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing|"For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:~The subject could not use the product without HCP assistance.~The subject could not complete the test. User error rendered one or more parts unusable.~The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value."|One hour||||percentage of subjects|||Number
2761104|NCT00798486|Secondary|Average Within Subject Coefficient of Variation CV (PRECISION)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|One hour|Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code.|||average percentage CV|||Number
2761105|NCT00798486|Primary|Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)|This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.|One hour||||number of A1c results|||Number
2761106|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Episodes per 24 hours||Full Range|Median
2761107|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Micturitions per 24 hours||Standard Deviation|Mean
2761108|NCT00798434|Other Pre-specified|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Micturitions per 24 hours||Standard Deviation|Mean
2761109|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Episodes per 24 hours||Standard Deviation|Mean
2761110|NCT00798434|Other Pre-specified|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of >=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Episodes per 24 hours||Standard Deviation|Mean
2761111|NCT00798434|Other Pre-specified|Percentage of Participants With Improvement at Week 24|"Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment. Treatment Response was set to Yes if the first 2 categories (1 or 2) of the scale selected and No if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2."|Pre-baseline and Week 24|Not analyzed|||Percentage of participants|||Number
2761112|NCT00798434|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.|Baseline and Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
2761113|NCT00798434|Secondary|Change From Baseline in EQ-5D- Each Dimension Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|Not analyzed|||Scores on a scale||Standard Deviation|Mean
2761114|NCT00798434|Secondary|Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.|||Scores on a scale||Standard Deviation|Mean
2761115|NCT00798434|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.|Baseline and Week 12|FAS; N=participants with evaluable data at sites in the United Kingdom only; n=participants with evaluable data for specific KHQ category. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
2761116|NCT00798434|Secondary|Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24|OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
2761117|NCT00798434|Secondary|Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24|OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
2761524|NCT00795951|Primary|Diagnostic Performance: Ethylenediamine Dihydrochloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761118|NCT00798434|Secondary|Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.|||Scores on a scale||Standard Deviation|Mean
2761119|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.|||Scores on a scale||Standard Deviation|Mean
2761120|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.|||Scores on a scale||Standard Deviation|Mean
2761121|NCT00798434|Secondary|Change From Baseline in PPUS at Week 24|PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 24|Not analyzed|||Participants|||Number
2761122|NCT00798434|Secondary|Change From Baseline in PPUS at Week 12|PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Participants|||Number
2761123|NCT00798434|Secondary|Change From Baseline in PPUS at Week 8|PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 8|FAS; N=participants with evaluable data|||Participants|||Number
2761124|NCT00798434|Secondary|Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4|PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Weeks 4|FAS; N=participants with evaluable data|||Participants|||Number
2761125|NCT00798434|Secondary|Change From Baseline in PPBC at Week 24|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 24|Not analyzed|||Participants|||Number
2761126|NCT00798434|Secondary|Change From Baseline in PPBC at Week 12|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Participants|||Number
2761162|NCT00798161|Secondary|HbA1c Change From Baseline at Week 24 for Open-label Patients|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with an on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.|||Percent||Standard Deviation|Mean
2761127|NCT00798434|Secondary|Change From Baseline in PPBC at Week 8|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 8|FAS; N=participants with evaluable data|||Participants|||Number
2761128|NCT00798434|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline and Week 4|FAS; N=participants with evaluable data|||Participants|||Number
2761129|NCT00798434|Secondary|Percentage of Participants With Improvement at Week 12|"Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment. Improvement was defined as a rating of 1 or 2."|Week 12|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percentage of participants|||Number
2761130|NCT00798434|Secondary|Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12|Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Skin protective agents||Standard Deviation|Mean
2761131|NCT00798434|Secondary|Percentage of Participants Who Were Incontinent at Baseline and Became Dry|Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Weeks 8 to 12|FAS; N=number of participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percentage of participants|||Number
2761132|NCT00798434|Secondary|Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12|USS total range 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
2761133|NCT00798434|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
2761134|NCT00798434|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Episodes per 24 hours||Full Range|Median
2761135|NCT00798434|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
2761136|NCT00798434|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Micturitions per 24 hours||Standard Deviation|Mean
2761137|NCT00798434|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
2761430|NCT00796562|Secondary|Relapse|Percentage of participants who experienced disease progression or relapse. This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)|1 year, 3 years|The entire set of participants was analyzed as one group, and the analysis was planned this way from the beginning of the study.|||percentage of participants||95% Confidence Interval|Number
2761138|NCT00798434|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Micturitions per 24 hours||Standard Deviation|Mean
2761139|NCT00798434|Secondary|Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
2761140|NCT00798434|Secondary|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Episodes per 24 hours||Standard Deviation|Mean
2761141|NCT00798434|Secondary|Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of >=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS;N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
2761142|NCT00798434|Primary|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 12|Full Analysis Set (FAS)=randomized participants who took at least 1 dose of double-blind (DB) treatment, had baseline and post-baseline efficacy data for at least 1 endpoint and at least 1 time point during DB treatment; number of participants analyzed (n)=participants with evaluable data at the specified time point.|||Episodes per 24 hours||Standard Deviation|Mean
2761143|NCT00798369|Secondary|Amount of Rescue Medication Taken for Each Treatment Group|Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone [30 mg]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.|7 days after study drug administration|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||mg||Standard Deviation|Mean
2761144|NCT00798369|Primary|The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)|Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).|at 24,48 and 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||mg||95% Confidence Interval|Number
2761145|NCT00798369|Secondary|Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mg/L||Standard Error|Least Squares Mean
2761146|NCT00798369|Secondary|High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||mg/L||Standard Error|Least Squares Mean
2761147|NCT00798369|Secondary|The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint|The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).|Baseline, within 7 days after randomization|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||Days||95% Confidence Interval|Median
2761148|NCT00798369|Secondary|Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment|Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.|at 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
2761149|NCT00798369|Secondary|The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide|The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline).|Baseline,at 72 hrs post-dose and 7 days post-dose|Full Analysis Set consisting of all participants with data for baseline and the given time point for each arm/group. Assessments up to Day 8, with 1 missing pain intensity value had it imputed. LOCF method was applied to impute post-dose measurements. Missing baseline values were replaced by the median baseline assessment|||Units on a scale||Standard Error|Least Squares Mean
2761150|NCT00798317|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)|||percentage of participants|||Number
2761151|NCT00798317|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28|Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)|||percentage of participants|||Number
2761152|NCT00798304|Primary|Percentage of Participants With at Least One Adverse Event (AE)||From signing of informed consent form to completion of study (up to 2 years)||||percentage of participants|||Number
2761153|NCT00798304|Other Pre-specified|Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
2761154|NCT00798304|Other Pre-specified|Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
2761155|NCT00798304|Other Pre-specified|Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
2761156|NCT00798304|Secondary|Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
2761157|NCT00798304|Secondary|Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
2761158|NCT00798304|Primary|Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 3|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
2761159|NCT00798174|Primary|Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil.|"Defibrillation threshold will be estimated by repeat defibrillation testing using an azygos coil and using an SVC coil (and compared).~The outcome measure quoted below is the mean DFT using the azygos coil vs. the mean DFT using the standard configuration."|During the course of the implant procedure and testing|All enrolled patient who were able to undergo azygos coil implant and defibrillation testing.|||Joules||Standard Deviation|Mean
2761160|NCT00798161|Secondary|Use of Rescue Therapy|The use of rescue therapy (SUs, thiazolidinediones [TZDs], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.|24 weeks|Percentage of patients requiring rescue therapy|||percentage of participants|||Number
2761161|NCT00798161|Secondary|FPG Change From Baseline at Week 24 for Open-label Patients|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with a baseline on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.|||mg/dL||Standard Deviation|Mean
2761163|NCT00798161|Secondary|Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.|Baseline and week 24|Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Mean
2761164|NCT00798161|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2761165|NCT00798161|Secondary|Percentage of Patients With HbA1c < 6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2761166|NCT00798161|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =< 6.5%|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2761167|NCT00798161|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2761168|NCT00798161|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2761169|NCT00798161|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2761170|NCT00798161|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2761171|NCT00798161|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2761172|NCT00798161|Secondary|FPG Change From Baseline at Week 2|This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 2|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2761173|NCT00798161|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2761174|NCT00798161|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2761175|NCT00798161|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2761176|NCT00798161|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2761319|NCT00796757|Secondary|OS - Time to Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||months||95% Confidence Interval|Median
2761177|NCT00798161|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2761178|NCT00798135|Secondary|Time to Progression.|This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.|up to 100 months|All patients in the study.|||Months||95% Confidence Interval|Median
2761179|NCT00798135|Secondary|Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment|Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.|up to 100 months|All patients in the study.|||Participants|||Number
2761180|NCT00798135|Primary|Pharmacokinetics (PK) of Oral Itraconazole|To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.|pre-dose at Weeks 2 and 4|All patients with results available.|||ng/mL||Standard Deviation|Mean
2761181|NCT00798096|Secondary|Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.|Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Days||Standard Deviation|Median
2761182|NCT00798096|Secondary|Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).|Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Participants|||Number
2761183|NCT00798096|Secondary|Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Participants|||Number
2761184|NCT00798096|Primary|The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD).|Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Participants|||Number
2761185|NCT00798018|Primary|Visual Analogue Scale(0-100mm) by the Subject.|visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.|6 hours, 12 hours, 24 hours, 48 hours after extubation||||mm||Standard Deviation|Mean
2761186|NCT00797966|Secondary|Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).|CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved].|Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||percentage of participants|||Number
2761187|NCT00797966|Secondary|Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).|A MADRS remission was defined as MADRS Total Score </= 10 and >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Percentage of participants|||Number
2761188|NCT00797966|Secondary|Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).|A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Percentage of participants|||Number
2761189|NCT00797966|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.|CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2761190|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.|"The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the best rating and the highest score (2 or 4) is the worst rating. The possible total scores are from 0 to 52."|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2761191|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place."|Week 8 to each of Week 9, 10, 11, 12, 13 and 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2761192|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2761193|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2761194|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2761195|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|"The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2761196|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).|The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2761431|NCT00796562|Secondary|Survival|Percentage of participants alive (overall survival) and alive without disease relapse, progression, or diagnosis of myeloid malignancy (event-free survival). Estimated using Kaplan-Meier method.|1 year, 2 years, 3 years||||percentage of participants||95% Confidence Interval|Number
2761197|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).|The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Percentage of maximum possible score||Standard Error|Least Squares Mean
2761198|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2761199|NCT00797966|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|"The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 8 to Week 14|Intent-to-Treat (ITT) dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The Last Observation Carried Forward (LOCF) method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
2761200|NCT00797862|Post-Hoc|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 & 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msSBP was a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2761201|NCT00797862|Secondary|Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints|Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints.|Baseline to week 8, 16, 24 and 32 endpoints|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure. Last post-baseline observation was carried forward to each visit for the analysis of blood pressure control.|||Percentage of Participants|||Number
2761202|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2761203|NCT00797862|Secondary|Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline, 8 weeks, 16 weeks and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2761223|NCT00797563|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol|||percent of participants|||Number
2761204|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32|Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2761205|NCT00797862|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2761206|NCT00797862|Primary|Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks|Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline, 8 weeks, 16 weeks, and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2761207|NCT00797823|Secondary|Percent of Time Venous Blood Glucose <70 mg/dl||1 year||||percent of time||Standard Error|Mean
2761208|NCT00797823|Primary|Effectiveness of Closed Loop Diabetes Control|Effectiveness of closed loop diabetes control will be measured by mean glucose.|1 year|The number of participants for analysis was determined was per protocol.|||mg/dl||Standard Error|Mean
2761209|NCT00797797|Secondary|Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study|The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).|Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)||||mm||Standard Error|Least Squares Mean
2761210|NCT00797797|Primary|Patient Global Impression of Change (PGIC) Responder Rate at End of Study|"The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as very much improved or much improved (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1."|End of Randomized treatment period (11 weeks)|All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.|||participants|||Number
2761211|NCT00797732|Secondary|MDADI Scores|The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.|Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture|The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.|||units on a scale||Standard Deviation|Mean
2761212|NCT00797732|Secondary|MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)|The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.|Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT|The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture|||units on a scale||95% Confidence Interval|Mean
2761213|NCT00797732|Primary|Treatment Compliance Rate|Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).|Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)|The analysis population is comprised of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2761214|NCT00797732|Primary|Outcome Compliance Rate|Outcome compliance rate is the percentage of enrolled participants who completed the primary study assessments (at baseline and in long-term follow-up 6 months post acupuncture treatment).|Assessed at baseline and at 6 months post acupuncture treatment|The analysis population is comprised of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2761288|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils - All Treated Population|Neutrophils (absolute) are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761215|NCT00797667|Primary|Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.|up to 12 weeks|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.|||Percentage of Participants|||Number
2761216|NCT00797667|Primary|Percentage of Participants Who Experienced an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 12 weeks)|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.|||Percentage of Participants|||Number
2761217|NCT00797667|Secondary|Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication|Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Days per month||95% Confidence Interval|Mean
2761218|NCT00797667|Secondary|Change From Baseline in the Mean Monthly Migraine Attacks|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||attacks per month||95% Confidence Interval|Mean
2761219|NCT00797667|Secondary|Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized|Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Percentage of Participants||95% Confidence Interval|Number
2761220|NCT00797667|Primary|Change From Baseline in Mean Monthly Migraine Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Days per month||95% Confidence Interval|Mean
2761221|NCT00797667|Primary|Change From Baseline in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Days per month||95% Confidence Interval|Mean
2761222|NCT00797563|Secondary|Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour||||number of participants|||Number
2761224|NCT00797563|Primary|Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.|One hour|"One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study.~The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method."|||number of blood glucose (BG) results|||Number
2761225|NCT00797511|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine|Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2761226|NCT00797511|Primary|Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio|Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2761227|NCT00797511|Primary|Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination|Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2761228|NCT00797511|Primary|Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.|Day 28 post-vaccination|Anti-Pertussis concentrations were assessed in the per-protocol population.|||Participants|||Number
2761229|NCT00797511|Primary|Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|"Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution)."|Day 28 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.|||Participants|||Number
2761230|NCT00797459|Secondary|Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline||||participants|||Number
2761231|NCT00797459|Primary|Treatment Difference in Pain as Measured by a Visual Analogue Scale|No pain is noted at 0 mm and worst pain is noted at 100 mm.|After Injection on Day of Treatment|This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS).|||Scores on a VAS Scale|Participants|Standard Deviation|Mean
2761232|NCT00797316|Secondary|Change From Baseline to Week 8 in Pulse Pressure||Baseline and Week 8|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
2761233|NCT00797316|Secondary|Percentage of Patients Achieving Blood Pressure Control at Week 8|Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.|8 weeks|Full analysis set|||Percentage of Participants|||Number
2761234|NCT00797316|Secondary|Percentage of Participants With Blood Pressure Response at Week 8|Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.|8 weeks|full analysis set|||Percentage of Participants|||Number
2761235|NCT00797316|Secondary|Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)||8 weeks|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
2761236|NCT00797316|Primary|Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
2761237|NCT00797277|Secondary|Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection|Agitation was further assessed by the Agitation Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company), a single-item scale developed by Eli Lilly and Company on which 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unable to be aroused.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection|||units on a scale||Standard Deviation|Mean
2761266|NCT00797108|Other Pre-specified|Number of Participants With Healthcare Resource Utilization|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization, date of discharge, location of discharge, type/length of treatment inside and outside of the hospital, healthcare professional visits outside of the hospital, emergency room visits, and other hospitalizations.|Baseline up to 15 to 28 days after EOT|This assessment was not performed due to the small sample size and hence data for this outcome measure is not reported.||||||
2761238|NCT00797277|Primary|The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection|The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection|||units on a scale||Standard Deviation|Mean
2761239|NCT00797225|Secondary|Number of Days to First Posttreatment Menses|Defined as the number of days from the last dose of study drug until the start date of the first post-treatment menses.|From last day of study drug up to 6 weeks after the last dose.|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) with non-missing post-treatment data.|||days||Full Range|Median
2761240|NCT00797225|Secondary|Percentage of Days With Uterine Bleeding|"Uterine bleeding was reported daily by participants during the study using the e-Diary.~The percentage of days a participant reported any bleeding was calculated as the total number of days the participant reported any bleeding ( light, moderate, or heavy) divided by the total number of days the participant had a non-missing eDiary report of vaginal bleeding in the phase."|Screening (8 weeks prior to day 1), Treatment phase (weeks 1 to 12 for participants in the placebo and leuprorelin treatment groups and weeks 1 to 24 for participants in the elagolix treatment groups)|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set).|||percentage of days||Standard Error|Mean
2761241|NCT00797225|Secondary|Average Number of Hot Flashes Per Day|"Hot flashes, if any, were reported daily by participants during the study using the e-Diary.~The average number of hot flashes per day was calculated for each participant as the total number of hot flashes divided by total days in the phase."|Screening (8 weeks prior to day 1), Treatment phase (weeks 1 to 12 for participants in the placebo and leuprorelin treatment groups and weeks 1 to 24 for participants in the elagolix treatment groups)|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set).|||hot flashes per day||Full Range|Median
2761242|NCT00797225|Secondary|Change From Baseline in Serum N-telopeptide Concentration at Week 12|Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA).|Baseline and week 12|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) and with available data at baseline and week 12.|||nM bone collagen equivalents (BCE)||Standard Error|Mean
2761243|NCT00797225|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24|Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and Week 24|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) and with available BMD data at baseline and week 24.|||percent change||Standard Deviation|Mean
2761244|NCT00797225|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24|Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and Week 24|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) and with available BMD data at baseline and week 24.|||percent change||Standard Deviation|Mean
2761245|NCT00797225|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12|Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and week 12|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) and with available BMD data at baseline and week 12.|||percent change||Standard Deviation|Mean
2761246|NCT00797225|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12|Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and week 12|Participants who received at least one dose of randomized, double-blind study drug (safety analysis set) and with available BMD data at baseline and week 12.|||percent change||Standard Deviation|Mean
2761247|NCT00797225|Secondary|Concentration of Serum Estradiol|The concentration of serum estradiol (E2) was quantified using liquid chromatography with tandem mass spectrophotometry (LC/MS/MS). Serum estradiol concentrations below the limit of quantification (BLQ) were set equal to the lower limit of quantification (2.5 pg/mL).|Baseline and Weeks 4, 8 and 12|Randomized participants who received at least one dose of randomized, double-blind study drug with at least one eDiary value following randomization, excluding participants who had less than 80% oral study drug dosing compliance during Weeks 1-12 (per protocol population). The analysis includes participants with non-missing data at each time point.|||pg/mL||Full Range|Median
2761248|NCT00797225|Secondary|Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)~A supplemental questionnaire consisting of six additional questions which assess the areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.~The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life."|Baseline and week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data for each dimension at baseline and week 12.|||units on a scale||Standard Error|Mean
2761249|NCT00797225|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved|"The PGIC is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2761250|NCT00797225|Secondary|Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved|"The PGIC is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2761251|NCT00797225|Secondary|Patient Global Impression of Change at Weeks 4, 8 and 12|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2761252|NCT00797225|Secondary|Change From Baseline in Non-menstrual Pelvic Pain CPSSS Component|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration.~To assess non-menstrual pelvic pain, participants were asked to select the best description of pelvic pain over the past 28 days using the following response categories:~0 = Absent; No discomfort.~1 = Mild; Occasional pelvic discomfort that can be treated with NSAIDs.~2 = Moderate; Noticeable discomfort or pain for most of cycle requiring regular use of NSAID or weak opiate.~3 = Severe; Pain persisting during the cycle or pain requiring strong analgesics."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). Data collection for this endpoint was added via a protocol amendment; therefore, the analysis only includes the subset of participants affected by the protocol amendment.|||units on a scale||Standard Error|Least Squares Mean
2761253|NCT00797225|Secondary|Change From Baseline in Dysmenorrhea Component of the CPSSS|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration.~To assess dysmenorrhea (pain during menstruation), participants were asked to select the best description of painful menstruation over the past 28 days using the following response categories:~0 = Absent; Amenorrhea (no bleeding) or no discomfort.~1 = Mild; Some loss of work efficiency; occasional use of analgesics.~2 = Moderate; In bed part of one day, occasional loss of work; regular use of analgesics.~3 = Severe; In bed ≥ 1 day, incapacitation; requirement for strong analgesics."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). Data collection for this endpoint was added via a protocol amendment; therefore, the analysis only includes the subset of participants affected by the protocol amendment.|||units on a scale||Standard Error|Least Squares Mean
2761254|NCT00797225|Secondary|Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration.~To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories:~0 = Absent; No discomfort during sexual intercourse.~1 = Mild; I can tolerate the discomfort during sexual intercourse.~2 = Moderate; Intercourse is sometime interrupted due to pain.~3 = Severe; I prefer to avoid intercourse because of pain.~Not applicable. I am not sexually active for reasons other than my endometriosis symptoms."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at baseline and at each time point.|||units on a scale||Standard Error|Least Squares Mean
2761255|NCT00797225|Secondary|Change From Baseline in the Percentage of Days of Narcotic Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline, Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2761256|NCT00797225|Secondary|Change From Baseline in the Percentage of Days of Prescription Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline, Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2761267|NCT00797108|Other Pre-specified|Population Pharmacokinetics|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study.|0.5 to 1 hours, 1.5 to 3 hours, 3 to 5 hours after initiation of first intravenous dose; 0.5 to 2.5 hours, 4 to 6 hours following administration of oral dose on the day of IV to oral switch (minimum of 2 days equivalent on intravenous dose)|||||||
2761525|NCT00795951|Primary|Diagnostic Performance: Balsam of Peru|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761257|NCT00797225|Secondary|Change From Baseline in the Percentage of Days of Any Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline, Weeks 4, 8 and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2761258|NCT00797225|Secondary|Change From Baseline in the Monthly Mean Sum of Dysmenorrhea and Non-menstrual Pelvic Pain Scores|"Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary. The dysmenorrhea scale included an option for participants who were not having their period.~The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2761259|NCT00797225|Secondary|Change From Baseline in the Monthly Mean Dysmenorrhea Score|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day of their period in an e-Diary according to the following response options:~Subject is not having her period~0 = No pain related to period~1 = Mild pain related to period; subject could not do some of the things she usually does~2 = Moderate pain related to period; subject could not do many of the things she usually does~3 = Severe pain related to period; subject could not do most of or all of the things she usually does.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2761260|NCT00797225|Secondary|Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:~0 = No pelvic pain~1 = Mild pelvic pain; subject could not do some of the things she usually does~2 = Moderate pelvic pain; subject could not do many of the things she usually does~3 = Severe pelvic pain; subject could not do most or all of the things she usually does.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2761261|NCT00797225|Secondary|Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2761262|NCT00797225|Primary|Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2761263|NCT00797212|Secondary|Percentage of Participant Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|per protocol|||percent of participants|||Number
2761264|NCT00797212|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants as to their success at performing meter testing. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol|||percent of participants|||Number
2761265|NCT00797212|Primary|Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results|Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP|One hour|per protocol|||number of AST Blood Glucose Results|||Number
2761268|NCT00797108|Other Pre-specified|Number of Participants With Categorical Change From Baseline in Vital Signs|Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants evaluable for this measure for specified category for each arm, respectively.|||participants|||Number
2761269|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator's discretion.|Last observation (up to 15-28 days after EOT, approximately 38 days)|ITT population included all randomized participants who received at least 1 dose of double blind study drug.|||participants|||Number
2761270|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2761271|NCT00797108|Other Pre-specified|Number of Participants Who Died||Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug.|||participants|||Number
2761272|NCT00797108|Secondary|Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit|The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness).|Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)|Clinically evaluable population. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2761273|NCT00797108|Secondary|Number of Participants With Microbiological Response at Test of Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data.|7 to 14 days after EOT|Microbiologic clinically evaluable population included all microbiologic ITT participants (all ITT participants in whom a pathogen was isolated at baseline) who also met criteria for the clinically evaluable subset.|||participants|||Number
2761274|NCT00797108|Secondary|Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit|"CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as cure=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; failure=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as improvement= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and indeterminate=extenuating circumstances precluded classification to 1 of the above at follow-up."|EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).|||percentage of participants|||Number
2761287|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils Plus Bands - All Treated Population|Neutrophils plus bands (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5.|Day 1 to Week 48||||participants|||Number
2761275|NCT00797108|Primary|Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit|"Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment [EOT]) CR was evaluated as cure=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; failure=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell [WBC] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; indeterminate=extenuating circumstances precluded classification to 1 of the above."|7 to 14 days after end of treatment|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).|||percentage of participants|||Number
2761276|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Uric Acid - All Treated Population|Uric acid was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 * ULN - 10.0; GRADE (4): > 10.0 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761277|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Lipase - All Treated Population|Total Lipase (as measured with a turbidimetric assay) was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * ULN; GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 X ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761278|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Calcium (High) - All Treated Population|Total Calcium was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 8.0 - < LLN OR > ULN - 11.5; GRADE (2): 7.0 - < 8.0 > 11.5 - 12.5; GRADE (3): 6.0 - < 7.0 > 12.5 - 13.5; GRADE (4): < 6.0 > 13.5 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761279|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Amylase - All Treated Population|Amylase was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761280|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Serum Potassium (High) - All Treated Population|Serum potassium was measured as milliequivalents per liter (mEq/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN OR > ULN - 5.5;; GRADE (2): > 5.5 - 6.0; GRADE (3): 2.5 - < 3.0 > 6.0 - 7.0; GRADE (4): < 2.5 mEq/L.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761281|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Bilirubin - All Treated Population|Total Bilirubin was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 3.0 * ULN; GRADE (3): > 3.0 - 10.0 * ULN; GRADE (4): > 10.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761282|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alkaline Phosphatase - All Treated Population|Alkaline Phosphatase was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761283|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Albumin - All Treated Population|Albumin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): < LLN - 3.0; GRADE (2): < 3.0 - 2.0; GRADE (3): < 2.0 g/dL.|Day 1 to Week 48||||participants|||Number
2761284|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Aspartate Aminotransferase (AST) - All Treated Population|AST was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48||||participants|||Number
2761285|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alanine Aminotransferase (ALT) - All Treated Population|ALT was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761286|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Platelet Count - All Treated Population|Platelets were measured as *10^9 cells per liter (c/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 75.0 - < LLN; GRADE (2): 50.0 - < 75.0; GRADE (3): 25.0 - < 50.0; GRADE (4): < 25.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761526|NCT00795951|Primary|Diagnostic Performance: Negative Control|Number of subjects with positive reactions recorded at visit 3 or visit 4.|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761289|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Lymphocytes - All Treated Population|Lymphocytes (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 0.8 - < 1.5; GRADE (2): 0.5 - < 0.8; GRADE (3): 0.2 - < 0.5; GRADE (4): < 0.2|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761290|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Leukocytes - All Treated Population|Leukocytes are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN; GRADE (2): 2.0 - < 3.0; GRADE (3): 1.0 - < 2.0; GRADE (4): < 1.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761291|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Hemoglobin - All Treated Population|Hemoglobin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 10.0 - less than (<) lower limit of normal (LLN); GRADE (2): 8.0 - < 10.0; GRADE (3): 6.5 - < 8.0; GRADE (4): < 6.5|Day 1 to Week 48||||participants|||Number
2761292|NCT00796991|Secondary|Mean Baseline Change in Body Temperature at Weeks 16 and 48 - All Treated Population|Temperature was obtained while the participant was sitting down and was measured in degrees Fahrenheit (F). During the induction phase this vital sign was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Temperature was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a temperature value available for analysis.|||degrees F||Standard Deviation|Mean
2761293|NCT00796991|Secondary|Mean Change From Baseline in Respiration Rate at Weeks 16 and 48 - All Treated Population|Respiration rate was obtained while the participant was sitting down and measured in breaths per minute (bpm). During the induction phase respiration rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Respiration rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Respiration rate value available for analysis.|||bpm||Standard Deviation|Mean
2761294|NCT00796991|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 16 and 48 - All Treated Population|Pulse rate was obtained while the participant was sitting down and measured in beats per minute (bpm). During the induction phase pulse rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Pulse rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Pulse rate value available for analysis.|||bpm||Standard Deviation|Mean
2761295|NCT00796991|Secondary|Mean Change From Baseline at Weeks 16 and 48 in Diastolic and Systolic Blood Pressure - All Treated Population|Blood pressure was obtained while the participant was sitting down and was measured in millimeters of mercury (mmHg). During the induction phase blood pressure was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Orthostatic blood pressure was to be measured when clinically indicated (for example, participant was experiencing lightheadedness, dizziness, syncope). Blood pressures were recorded at Weeks 1, 4, 7, 10,13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had blood pressure value available for analysis.|||mmHg||Standard Deviation|Mean
2761296|NCT00796991|Secondary|Mean Absolute Lymphocyte Count (ALC) at Each Nominal Ipilimumab Induction Dose and at End of the Induction Period - Pharmacodynamic Population|Absolute lymphocyte counts were obtained from routine hematology panels from 28 days prior to the first treatment with any study medication through the end of the Induction-Dosing Period and were reported as number*10^3 cells per micro liter (x10^3 c/µL).|Day to Week 12|"Pharmacodynamic Population: All treated participants with one unambiguous date of first dose; and at least 1 ALC evaluation during the induction-dosing period. For each of these participants, all ALC evaluations from 28 days prior to first dose of any study medication to the end of the induction dosing are included.~period."|||10^3 cells/µL||95% Confidence Interval|Mean
2761297|NCT00796991|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, Deaths, and Discontinuation Due to Adverse Events From Day 1 to Week 48 - All Treated Population|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Week 48 database lock was 27 July 2010.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761298|NCT00796991|Secondary|Number of Participants With Objective Response to Treatment and Disease Control Using mWHO Criteria - All Randomized Participants|Number of participants with an objective response to treatment excluded participants with a best overall response (BOR) of Stable Disease (SD). Disease control is non-progression of disease while on treatment. A participant was considered to have achieved disease control if he/she had a BOR of CR, PR, or SD in the absence of resected index lesions or new lesions while the participant was considered to have an objective response to treatment in he/she had a BOR of CR or PR in the absence of resected index lesions or new lesions.|Day 1 to Week 48|Randomized Population includes all participants randomized to a treatment arm|||participants|||Number
2761320|NCT00796757|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants|||Number
2761527|NCT00795951|Primary|Diagnostic Performance: Paraben Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761299|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Immune Related (ir) Response Criteria (RC) - All Treated Participants|Assessments: Weeks 12, 16, 20, and 24. Participants with resected index or new lesions considered progressed in their disease. The immune-related (ir) response criteria (irRC) represents further modifications of mWHO criteria reflecting clinical experience with ipilimumab in which objective and durable responses (as per mWHO) were observed in participants following progression and without intervening alternative anti-cancer therapy. Immune-related (ir)Complete Response (irCR): Complete disappearance of all index lesions; ir Partial Response (irPR): Decrease, relative to baseline, of 50% or greater in sum of products of the two largest perpendicular diameters of all index and all new measurable lesions, in the absence of irCR; ir Stable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (PD); ir PD: At least 25% increase in Tumor Burden compared to sum of product diameters (SPD) at nadir. ir Unknown=participants overall response not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761300|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Modified World Health Organization (mWHO) Criteria - All Treated Participants|Assessments for antitumor activity by physical exam and routine anatomic imaging were at Week 12 and confirmatory imaging at Weeks 16, 20, and 24. Participants with resected index or new lesions were considered progressed in their disease. Complete Response (CR): Complete disappearance of all index lesions; Partial Response (PR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease (SD): Does not meet criteria for complete or partial response, in the absence of progressive disease. Participants with PR or CR that was not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions; Progressive Disease: At least 25% increase in the sum of products of all index lesions and/or the appearance of any new lesion(s). Unknown=the participants overall response was not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
2761301|NCT00796991|Secondary|Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Vss reported in liters(L): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||L||Geometric Coefficient of Variation|Geometric Mean
2761302|NCT00796991|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to 21 Days [AUC(0-21d)] for Ipilimumab and AUC Time Zero Extrapolated to Infinity [AUC(INF)] for Paclitaxel, Dacarbazine and the Active Metabolite AIC - Pharmacokinetic Analysis Population|AUC=micrograms*hour(h) per mL (µg*h/mL): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2761303|NCT00796991|Secondary|Pharmacokinetic Parameter of Clearance (CLT) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|CLT reported in milliliters/hour (mL/h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2761318|NCT00796757|Secondary|Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2761304|NCT00796991|Secondary|Pharmacokinetic Parameter of Terminal Elimination Half Life (T-HALF) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|T(HALF) reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||h||Standard Deviation|Mean
2761305|NCT00796991|Secondary|Pharmacokinetic Parameter of Time of Maximum Observed Concentration (Tmax) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Tmax reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||h||Full Range|Median
2761306|NCT00796991|Primary|Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population|Cmax=micrograms per milliliter (µg/mL): drug concentration versus time for ipilimumab (Day 43) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma by Enzyme-linked Immunosorbent Assay (ELISA); lower level of quantitation (LLOQ)=0.8 µg/mL; upper limit of quantitation (ULOQ)=25.6 µg/mL; Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; from Day 162 on every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined using liquid chromatography tandem mass spectrometry (LC/MS/MS) detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography atmospheric pressure ionization (API) tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate Pharmacokinetic (PK) profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2761307|NCT00796926|Secondary|Superior and Inferior Tear Meniscus Height|This is determined by anterior segment OCT visante system|6 weeks|||||||
2761308|NCT00796926|Secondary|Tear Osmolarity|This is measured by the TearLab (Ocusense) system|6 weeks|||||||
2761309|NCT00796926|Secondary|Meibography Grading||6 weeks|||||||
2761310|NCT00796926|Secondary|Schirmer I Reading||6 weeks|||||||
2761311|NCT00796926|Secondary|Tear Break Up Time (TBUT)||6 weeks|||||||
2761312|NCT00796926|Secondary|Corneal Fluorescein Staining Score|This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any|6 weeks|||||||
2761313|NCT00796926|Primary|Visual Analog Score (VAS)|Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum|6 weeks|intention to treat|||scores on a scale||Standard Deviation|Mean
2761314|NCT00796861|Primary|Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.|A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.|An average of every 6 weeks|No analyses were performed as none of the subjects made it through a full cycle.||||||
2761315|NCT00796822|Secondary|Change in Soluble TNF-Receptor I Levels|Measure of systemic inflammation|Measured at baseline and Week 8|Those who had both baseline and Week 8 data available|||pg/mL||Standard Deviation|Mean
2761316|NCT00796822|Primary|Change in Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.|Measured at baseline and Week 8|Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.|||absolute percentage||Standard Deviation|Mean
2761317|NCT00796757|Secondary|EQ-5D - Visual Analog Scale (VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2761321|NCT00796757|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months|OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants||95% Confidence Interval|Number
2761322|NCT00796757|Primary|PFS - Time to Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population|||months||95% Confidence Interval|Median
2761323|NCT00796757|Primary|PFS - Percentage of Participants With an Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants|||Number
2761324|NCT00796757|Secondary|Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)|Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population; only participants with measurable disease were included in the analysis.|||percentage of participants|||Number
2761325|NCT00796757|Primary|Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|12 and 24 months|ITT population|||percentage of participants||95% Confidence Interval|Number
2761326|NCT00796744|Secondary|The Time to Re-epithelialization of the Ulcer Site.|Average time to complete re-epithelialization of baseline ulcer area.|24 weeks||||Weeks||Standard Error|Mean
2761327|NCT00796744|Secondary|The Rate of Re-epithelialization of the Ulcer Site.|The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.|12 weeks||||percent ulcer area re-epithelialized/wk||Standard Deviation|Mean
2761328|NCT00796744|Secondary|The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.||Duration of subject's participation (24 weeks)|Safety Population|||patients|||Number
2761329|NCT00796744|Primary|The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.||Healing to occur within 12 weeks of first treatment|Intent-to-Treat Population|||number of ulcers healed|||Number
2761330|NCT00796718|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Up to 15 weeks|All enrolled participants.|||percentage of participants|||Number
2761331|NCT00796718|Secondary|Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 15 weeks (assessed 1 month after surgery)|Participants with available data.|||percentage of participants|||Number
2761332|NCT00796718|Secondary|Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)|Participants with available data.|||percentage of participants|||Number
2761333|NCT00796718|Primary|Percentage of Participants With Pathological Complete Response|Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.|Up to 11 weeks (assessed at the time of post-treatment surgery)|Participants with available data.|||percentage of participants|||Number
2761334|NCT00796705|Secondary|Participants With an ACR 70 Response at Week 12|"The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
2761335|NCT00796705|Secondary|Participants With an ACR 50 Response at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
2761336|NCT00796705|Secondary|Participants With an ACR 20 Response at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
2761337|NCT00796705|Secondary|Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)|The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2.|Baseline, Week 12|Intent-to-treat|||participants|||Number
2761338|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat|||participants|||Number
2761339|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat|||participants|||Number
2761340|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
2761341|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
2761342|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761343|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761344|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761428|NCT00796614|Secondary|Change From Baseline in LPP at Week 14 (End of Treatment)|Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.|Baseline and Week 14|Full analysis set-LPP (FAS-LPP), OT|||cm H2O||Standard Error|Least Squares Mean
2761345|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761346|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761347|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761348|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761349|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761350|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761351|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 and ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
2761352|NCT00796666|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48|WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.|Baseline, Weeks 12, 24 or ET|ITT|||participant|||Number
2761353|NCT00796666|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline.|Baseline to Weeks 12 and 24|ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method|||meters (m)||Standard Deviation|Mean
2761354|NCT00796666|Primary|Time to Clinical Worsening (TTCW)|Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study's first dose date in and date when first clinical worsening event occurs.|Baseline, Weeks 12, 24 or Early Termination (ET)|Intent-to-Treat population (ITT): all participants who were randomized|||Days||Full Range|Median
2761432|NCT00796562|Secondary|Chronic GVHD|Percentage of participants who experience chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria. This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)|6 months, 12 months||||percentage of participants||95% Confidence Interval|Number
2761355|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
2761356|NCT00796653|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2761357|NCT00796653|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.|||percentage of participants|||Number
2761358|NCT00796653|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
2761359|NCT00796653|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
2761360|NCT00796653|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
2761361|NCT00796653|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
2761362|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
2761363|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
2761364|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761365|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761366|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761451|NCT00796510|Secondary|Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24|The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.|Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||||||
2761367|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761368|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761369|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761370|NCT00796653|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761371|NCT00796653|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761372|NCT00796653|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761373|NCT00796653|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761374|NCT00796653|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS|||Number of puffs||Standard Error|Mean
2761375|NCT00796653|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS|||L/min||Standard Error|Mean
2761376|NCT00796653|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761377|NCT00796653|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761452|NCT00796510|Primary|Overall Survival|Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.|Baseline and every 12 weeks up to Week 18|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||||||
2761378|NCT00796653|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761379|NCT00796653|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761380|NCT00796653|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761381|NCT00796653|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
2761382|NCT00796653|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
2761383|NCT00796653|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
2761384|NCT00796653|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
2761385|NCT00796653|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
2761528|NCT00795951|Primary|Diagnostic Performance: Colophony|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761386|NCT00796653|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
2761387|NCT00796653|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
2761388|NCT00796653|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
2761389|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761390|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761391|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761392|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761529|NCT00795951|Primary|Diagnostic Performance: Fragrance Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761530|NCT00795951|Primary|Diagnostic Performance: Caine Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761393|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761394|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761395|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761396|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761397|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761398|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761399|NCT00796653|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
2761433|NCT00796562|Secondary|Acute GVHD|"Percentage of participants who experience grade II-IV or III-IV acute graft-versus-host-disease (GVHD) by Przepiorka criteria. The stages are defined as follows:~Stage II: Rash on >50% of skin, bilirubin 2-3 mg/dL, or diarrhea 500-1000 mL/day~Stage III: Bilirubin 3-15 mg/dL or diarrhea >1000 mL/day~Stage IV: Generalized erythroderma with bullae or bilirubin >15 mg/dL This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)"|Day 100||||percentage of participants||95% Confidence Interval|Number
2761400|NCT00796653|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
2761401|NCT00796653|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
2761402|NCT00796653|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
2761403|NCT00796653|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
2761404|NCT00796653|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
2761405|NCT00796653|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
2761406|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761407|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761434|NCT00796562|Secondary|Non-relapse Mortality|Number of participants deceased for reasons other than disease relapse or progression.|Day 100, 1 year||||Participants|||Count of Participants
2761408|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761409|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761410|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761411|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761412|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761413|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761414|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761415|NCT00796653|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
2761429|NCT00796614|Primary|Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.|The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.|Week 14|Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.|||Percentage of participants|||Number
2761416|NCT00796653|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761417|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|73 hours to 6 weeks post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
2761418|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|49 to 72 hours post-operative|Data only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
2761419|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|0 to 24 hours post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
2761420|NCT00796627|Primary|The Quantification of Circulating Angiogenic Cells in the Blood of Individuals Who Are Healthy Volunteers Compared to Those in Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|baseline||||cells per standard well||Full Range|Mean
2761421|NCT00796614|Secondary|Post Void Residual Volume at Week 14|Median change from baseline to Week 14 in post void residual (mL) by study treatment.|Baseline and Week 14.|Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.|||mL||Standard Deviation|Median
2761422|NCT00796614|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.|"Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.~Relevant findings or worsening of baseline conditions were reported as adverse events."|From first drug administration until 28 days after last study drug administration, upto 160 days|"Treated Set (TS).~All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study."|||Participants|||Number
2761423|NCT00796614|Secondary|Change From Baseline in Number of Times Patient Was Wet at Catheterisation|Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH)|||Times patient wet at catheterization||Standard Error|Least Squares Mean
2761424|NCT00796614|Secondary|Change From Baseline in Urine Volume at Week 14|Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.|||mL||Standard Error|Least Squares Mean
2761425|NCT00796614|Secondary|Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline|"Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).~Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14."|Baseline and Week 14|Full analysis set-renal (FAS-RENAL)|||Participants|||Number
2761426|NCT00796614|Secondary|Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline|"Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.~The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization"|Baseline and Week 14|Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.|||Participants|||Number
2761427|NCT00796614|Secondary|Percentage Change From Baseline in LPP at Week 14 (End of Treatment)|Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.|Baseline and Week 14.|Full analysis set-LPP (FAS-LPP), OT|||Percentage change||Standard Error|Least Squares Mean
2761435|NCT00796562|Primary|Engraftment as Measured by Donor Chimerism|Percentage of participants who achieved donor chimerism >=95%.|Day 60|8 participants were not evaluable for this outcome because they died prior to Day 60.|||percentage of participants||95% Confidence Interval|Number
2761436|NCT00796549|Secondary|Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status|"Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :~0 : Fully active, able to carry on all pre-disease performance without restriction.~: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.~: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.~: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.~: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.~: Dead.~Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included."|End Of Treatment, up until 190 weeks|Treated set (TS).|||percentage of participants|||Number
2761437|NCT00796549|Secondary|Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction|"Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.~There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF)."|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).|||percentage of participants|||Number
2761438|NCT00796549|Secondary|Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder|The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).|||Percentage of participants|||Number
2761439|NCT00796549|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.|Day 15|"Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data.~Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2761440|NCT00796549|Secondary|Overall Survival (OS) Time|Overall survival time is defined as time from the date of start of treatment to the date of death.|Baseline until last vital status assessment 17JUN13|Treated set (TS).|||Weeks||95% Confidence Interval|Median
2761441|NCT00796549|Secondary|Progression Free Survival (PFS) Time|Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||Weeks||95% Confidence Interval|Median
2761442|NCT00796549|Secondary|Duration of Confirmed Disease Control|Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||Weeks||Standard Deviation|Mean
2761443|NCT00796549|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||percentage of participants||95% Confidence Interval|Number
2761444|NCT00796549|Secondary|Duration of Confirmed Objective Response (OR)|Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).|||Weeks||Standard Deviation|Mean
2761445|NCT00796549|Secondary|Number of Participants With Objective Response (OR) Categorized by Time|Cumulative number of participants with objective response by time points with responders.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).|||percentage of participants|||Number
2761446|NCT00796549|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||percentage of participants||95% Confidence Interval|Number
2761447|NCT00796523|Primary|Hours Per Day of Sleep|mean sleep time is the mean of 3 daily sleep times reported in a time period.|week 8|Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis|||hours per day||Standard Deviation|Mean
2761448|NCT00796523|Primary|Hours Per Day of Fuss/Cry|total hours per day of fuss, cry, and unsoothable crying.|week 8|If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis|||hours per day||Standard Deviation|Mean
2761449|NCT00796523|Secondary|Parenting Stress Index|a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.|week 6|results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis|||points on a scale||Standard Deviation|Mean
2761450|NCT00796510|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)|The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).|Baseline, Week 12 and ET (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||||||
2761453|NCT00796445|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within the 31-day (Days 0-30) post-administration period, at Follow-up analysis|The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2761454|NCT00796445|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to study end (Year 5)|The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2761455|NCT00796445|Secondary|Number of Subjects With Any Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) follow-up period after vaccination - at Follow-up analysis|The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2761456|NCT00796445|Secondary|Number of Subjects With Abnormal Haematological and Biochemical Parameters|Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.|Within the 31-day (Days 0-30) post-vaccination period, at follow-up analysis|The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2761457|NCT00796445|Secondary|Number of Subjects With Anti-MAGE-A3 Antibody Response|Treatment response defined as: - For initially seronegative patients: post-vaccination antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.|At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.|||Participants|||Count of Participants
2761458|NCT00796445|Secondary|Anti-MAGE-A3 Antibody Geometric Mean Concentrations|Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.|At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2761459|NCT00796445|Secondary|Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value|The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw.|||Participants|||Count of Participants
2761460|NCT00796445|Secondary|Health-related Quality of Life|The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.|At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence|The analysis was performed on subjects with valid EQ-5D data from the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.|||Units on a scale||Standard Deviation|Mean
2761461|NCT00796445|Secondary|Distant Metastasis-free Survival (DMFS)|Distant Metastasis Free Survival (DMFS) was defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the sum of follow-up periods, in years, until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).|At Final analysis (Month 30 = Year 2.5)|The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.|||Years|||Number
2761531|NCT00795951|Primary|Diagnostic Performance: Potassium Dichromate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
2761462|NCT00796445|Secondary|Disease-free Specific Survival (DFSS)|Disease Free Specific Survival (DFSS) was defined as the interval from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the sum of follow-up periods, in years, until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).|At Final analysis (Month 30 = Year 2.5)|The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.|||Years|||Number
2761463|NCT00796445|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the interval from randomization to the date of death, irrespective of the cause of death. OS was expressed as the sum of follow-up periods, in years, until the occurrence of death.|At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)|The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.|||Years|||Number
2761464|NCT00796445|Primary|Disease Free Survival (DFS)|DFS = time from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the sum of follow-up periods, in years, until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).|At follow-up analysis (up to Year 5)|The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis.|||Years|||Number
2761465|NCT00796445|Primary|Disease Free Survival (DFS)|DFS = time from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the sum of follow-up periods, in years, until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).|At Final analysis (Month 30 = Year 2.5)|The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study.|||Years|||Number
2761466|NCT00796419|Secondary|Ventilator-free Days|The 'ventilator free survival days' in a 30-day period is a previously validated method of comparing groups with respect to mechanical ventilator requirements while adjusting for mortality. This variable represents the number of days in the 30-day period following baseline that the patient is alive and not requiring mechanical ventilation.|Day 30||||days||Inter-Quartile Range|Median
2761467|NCT00796419|Secondary|Change in Oxygenation (PaO2/FiO2 Ratio)|Change in arterial oxygenation measured by arterial blood gas analysis. The partial pressure of O2 in arterial blood to fraction of inspired oxygen ratio (PaO2/FiO2) is a ratio of partial pressure arterial oxygen to fractional inspired inspired oxygen. This ratio is used as an indicator of hypoxemia (low blood oxygen). A PaO2/FiO2 ratio of 200-300 indicates mild ARDS, 100-200 indicates moderate ARDS, and less than 100 indicates severe ARDS.|Baseline, Day 1||||mmHg||Standard Deviation|Mean
2761468|NCT00796419|Primary|Change in Extravascular Lung Water (EVLW)|Quantity of extravascular lung water (EVLW) measured by transpulmonary thermodilution. Higher measurements of EVLW per kilogram of body weight indicate increased lung injury. Normal values for EVLW are thought to be less than 10 mL/kg.|Baseline to Day 5 (120 hours)||||mL/kg||Standard Deviation|Mean
2761469|NCT00796367|Primary|Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.||Baseline to End of Treatment|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent participants|||Number
2761470|NCT00796367|Primary|Percent Weight Change at End of Treatment, Week 108.||From baseline to end of treatment|Intent-to-Treat Last observation carried forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
2761471|NCT00796328|Primary|Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension|"The effective dose at which 90% of subjects will have a positive response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min."|Spinal administration until delivery||||dose of phenylephrine|||Number
2761472|NCT00796315|Primary|Cmax of Doxylamine|Maximum concentration of Doxylamine from 0 to 72 hours post-dose|72 Hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2761473|NCT00796315|Primary|AUC of Doxylamine|Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.|72 Hours||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2761474|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Severity of Illness|Using this clinician rating scale the severity of the illness is scored from 1= normal to 7= extremely ill. This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Severity of Illness scores are reported below.|Measured at endpoint visit|ADHD and severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Severity of Illness rating|||participants|||Number
2761532|NCT00795951|Primary|Diagnostic Performance: Wool Alcohol|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All enrolled subjects|||participants|||Number
2761475|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Improvement|"Using this clinician rating scale the patient's improvement is scored on a 7-point scale which ranges from very much improved (1), through no change (4), to very much worse (7). This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Improvement scores are reported below."|Measured at endpoint visit|ADHD & severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Improvement rating|||participants|||Number
2761476|NCT00796302|Other Pre-specified|Antisocial Behavior Scale - Reactive Aggression Subscale|The Antisocial Behavior Scale (ABS) is a 28-item scale that contains 10 Proactive Aggression items and six Reactive Aggression items. Each item is rated on a 3-point scale, ranging from 1 (Never) to 3 (Very often). Thus, scores on the Reactive Aggression subscale can range from 6 through 18; with higher scores indicating more reactive aggression.|Measured at baseline and Week 9|ADHD & severe physical aggression|||units on a scale||Standard Deviation|Mean
2761477|NCT00796302|Primary|NCBRF-TIQ D-Total Score|"Parent ratings of aggression and hostility on the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ) D-Total Score. The NCBRF provides 1 prosocial subscale (Positive/Social) and 6 problem behavior subscales (Conduct Problem, Oppositional Behavior, Hyperactive, Inattentive, Overly Sensitive, and Withdrawn/Dysphoric). The NCBRF has excellent internal consistency, distinguishes between controls and subjects with DBDs. Conduct Problem and Oppositional Behavior subscales map closely to DSM-IV-TR symptoms of CD and ODD; they were scored together to form a variable called the D-Total.~For the NCBRF D-Total, higher scores reflect worse behavior. Each subscale is scored by taking the rating (0 [did not occur or was not a problem] to 3 [occurred a lot or was a very severe problem]) for all component items. The D-Total score was computed by adding the 6 scores from the Oppositional subscale and the 10 items from the Conduct Problem subscale. Thus D-Total scores could range from 0-69."|Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9|ADHD & severe physical aggression|||units on a scale||Standard Deviation|Mean
2761478|NCT00796224|Secondary|Adverse Events (AEs) and Serious AEs (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.|Baseline up to 28 days|All subjects who received at least 1 dose of study medication were included in the safety analyses.|||participants|||Number
2761479|NCT00796224|Secondary|Number of Participants With a Clinical Response|"Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following:~Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary;~New clinical signs and symptoms of acute illness have developed and additional therapy is necessary"|Days 7,8,9 or 10|Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.|||participants|||Number
2761480|NCT00796224|Secondary|Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)||1,2,3,4,8,24,48,72 hours postdose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/ml|||Number
2761481|NCT00796224|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||hr||Full Range|Median
2761482|NCT00796224|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azithromycin||Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/ml||Standard Deviation|Mean
2761483|NCT00796224|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)|AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng*hr/ml||Standard Deviation|Mean
2761484|NCT00796224|Primary|Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)|AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.|Predose/0 to 72 Hours|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng*hr/ml||Standard Deviation|Mean
2761485|NCT00796120|Secondary|Duration of Response (DOR)|The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.|Up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2761486|NCT00796120|Secondary|Overall Survival|Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline up to End of Study (an average of 4 years)|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||months||95% Confidence Interval|Median
2761500|NCT00796003|Primary|Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.|Up to 1 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this analysis set for Phase II|||Participants|||Number
2761487|NCT00796120|Secondary|Percentage of Participants With Objective Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||percentage of participants||95% Confidence Interval|Number
2761488|NCT00796120|Secondary|6-month Progression - Free Survival|Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.|6 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||percentage of participants||95% Confidence Interval|Number
2761489|NCT00796120|Primary|Progression - Free Survival (PFS)|The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)|||months||95% Confidence Interval|Median
2761490|NCT00796003|Secondary|Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial)|IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality.|Up to 1.5 years after the last participant enrolled|20 participants who had chromosomal abnormality were evaluated in Phase II for cytogenetic response. The IWG criteria requires 20 analyzable metaphases using conventional cytogenetic techniques.|||Participants|||Number
2761491|NCT00796003|Secondary|Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 1.5 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this set|||Participants|||Number
2761492|NCT00796003|Secondary|Phase II: Median Duration of Overall Improvement|Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.|||Days||Full Range|Median
2761493|NCT00796003|Secondary|Phase II: Median Duration of Remission|Median time duration for which participants achieved remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.|||Days||Full Range|Median
2761494|NCT00796003|Secondary|Phase II: Median Time to Improvement|Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.|||Days||95% Confidence Interval|Median
2761495|NCT00796003|Secondary|Phase II: Median Time to Remission|Median time required for the participants to achieve remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.|||Days||95% Confidence Interval|Median
2761496|NCT00796003|Secondary|Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 28 Days of treatment Cycle 1|Full Analysis Set (FAS): 9 participants were included in this set for Phase I|||Participants|||Number
2761497|NCT00796003|Secondary|Phase I: Area Under the Plasma Concentration-time Curve (AUC)|Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last).|Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis|||ng*h/mL||Standard Deviation|Mean
2761498|NCT00796003|Secondary|Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)||Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis|||ng/mL||Standard Deviation|Mean
2761499|NCT00796003|Primary|Phase I and II: Number of Participants Who Experienced Adverse Events||Up to 1.5 years after the last participant enrolled|Safety Population: 9 participants in Phase I and 34 participants in Phase II were evaluated for safety|||Participants|||Number
2761501|NCT00795951|Secondary|Itching/Burning|Number of subjects who presented with itching/burning at patch removal|Day 2: 48 hours after patch application||||participants|||Number
2761502|NCT00795951|Secondary|Adhesion|Number of subjects who presented with poor adhesion at patch removal|Day 2: 48 hours after application||||participants|||Number
2761533|NCT00795951|Primary|Diagnostic Performance: Neomycin Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|The prevalence of allergic contact dermatitis varies greatly (≤1%-10%) in consecutive subjects. Therefore, estimates of sample size and study power are based on overall AE rates, which are generally similar across populations and test allergens and for which there is relevant historical data.|||participants|||Number
2761534|NCT00795951|Primary|Diagnostic Performance: Nickel Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All completed subjects were included in the efficacy analysis.|||participants|||Number
2761535|NCT00795886|Primary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation. The Kaplan-Meier product limit method was used to compute the probability of overall survival to 2 years. Greenwood's formula was used to compute the standard error.|24 months after transplant|All patients enrolled in study.|||probability||Standard Error|Mean
2761536|NCT00795886|Secondary|Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD)|Cumulative incidence of Grade 2-4 acute GVHD at 180 days.|180 days||||percentage of participants||95% Confidence Interval|Number
2761537|NCT00795886|Primary|Number of Participants With Transplant-related Mortality|Death not associated with relapse. We determined that if transplant related mortality(TRM) 25% at day 100 or if Grade III-IV (severe, life threatening, or disabling) acute GVHD was >30% a stopping rule would be triggered.|24 months after transplant|All participants enrolled in the trial.|||participants|||Number
2761538|NCT00795821|Secondary|Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684|Blood samples collected from participants that received LY2216684 were measured to determine the plasma LY2216684 concentrations.|Baseline through Week 62|N=number of participants analyzed (N=365); n=number of plasma LY2216684 concentration observations. The sum of the individual ‘n’ values for each dose group does not equal 365 since the same participant could have received various doses during his/her participation in the study.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2761539|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Supine Pulse at Week 62|Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2761540|NCT00795821|Secondary|Mean Change From Baseline in Supine Pulse at Week 10|Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2761541|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62|Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
2761542|NCT00795821|Secondary|Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10|Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
2761543|NCT00795821|Secondary|Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62|"C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a yes answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a yes answer to actual attempt or completed suicide."|Baseline (Week 10) through Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
2761544|NCT00795821|Secondary|Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10|"C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a yes answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a yes answer to actual attempt or completed suicide."|Baseline through Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline C-SSRS value.|||percentage of participants|||Number
2761545|NCT00795821|Secondary|Percentage of Participants Reporting Resource Utilization at Week 62|The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.|Baseline (Week 10) through Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
2761546|NCT00795821|Secondary|Percentage of Participants Reporting Resource Utilization at Week 10|The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.|Baseline through Week 10|The analysis population included all randomized participants.|||percentage of participants|||Number
2761547|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62|The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761548|NCT00795821|Secondary|Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10|The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761549|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62|"The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its worst, usual, and now during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit."|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761550|NCT00795821|Secondary|Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10|"The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its worst, usual, and now during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score."|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761551|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761552|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761553|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1-5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761554|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1 to 5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761594|NCT00795600|Secondary|Absolute Change in Creatine Phosphokinase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatine Phosphokinase at week 26.|||IU/L||Standard Deviation|Mean
2761555|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761556|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761557|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62|EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, mood. Single score between 1 and 3 was generated for each domain. For each participant, outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761558|NCT00795821|Secondary|Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10|EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761559|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62|The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761560|NCT00795821|Secondary|Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10|The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761561|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62|The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761562|NCT00795821|Secondary|Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10|The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all participants with a baseline and at least 1 post-baseline value in the Per Protocol population, defined as the subset of randomized participants who had baseline and post-baseline data collected using the correct version of the QIDS-SR16 worksheet.|||units on a scale||Standard Error|Least Squares Mean
2761563|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62|CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for investigator, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761595|NCT00795600|Secondary|Absolute Change in Creatinine||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatinine at week 26.|||mg/dL||Standard Deviation|Mean
2761564|NCT00795821|Secondary|Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10|CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761565|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761566|NCT00795821|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761567|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62|The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761568|NCT00795821|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10|The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2761569|NCT00795769|Primary|Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)|Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.|Baseline up to 120 minutes||||Participants|||Count of Participants
2761570|NCT00795717|Secondary|Brachial Artery Reactivity|"To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.~Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of % of brachial artery."|12 weeks||||% of brachial artery diameter||Standard Deviation|Mean
2761571|NCT00795717|Secondary|Serum HDL Level||12 weeks||||mg/dl||Standard Deviation|Mean
2761572|NCT00795717|Primary|Change in Baseline Mean Serum Triglyceride Level at Study End|Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo|Baseline and 12 weeks|Randomized, cross over design|||mg/dl||Standard Deviation|Mean
2761573|NCT00795704|Secondary|Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages|2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.|Baseline and 3 months|Intention-to-treat with data submitted baseline and final.|||mg/dL||Standard Deviation|Mean
2761574|NCT00795704|Secondary|Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels|Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.|Baseline, 1 month, and 3 months||||participants|||Number
2761575|NCT00795704|Primary|Hemoglobin A1C||3 month minus baseline|intention-to-treat|||percent||Standard Deviation|Mean
2761576|NCT00795639|Secondary|Time to Clinical Worsening (TTCW)|TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.|Baseline, Weeks 4, 8 and 12 or ET|ITT; N=number of participants with analyzable data|||days||Full Range|Median
2761577|NCT00795639|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12|WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.|Baseline, Weeks 4, 8 and 12 or Early Termination (ET)|ITT; N=number of participants with analyzable data; n=number of participants with analyzable data at the specific time point|||participants|||Number
2761578|NCT00795639|Primary|Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.|Baseline/Day 1 and Week 12|Intent to treat population (ITT): all participants who were randomized; missing value at Week 12 imputed with last non-missing value, including the non-missing value obtained at early termination based on last observation carried forward (LOCF)|||Meters (m)||Full Range|Median
2761579|NCT00795600|Secondary|Number of Non-serious Adverse Events|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.|||events|||Number
2761580|NCT00795600|Secondary|Number of Hypoglycaemic Episodes|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.|||episodes|||Number
2761581|NCT00795600|Secondary|Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.|||ng/L||Standard Error|Least Squares Mean
2761582|NCT00795600|Secondary|Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)|Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.|||mg/L||Standard Error|Least Squares Mean
2761583|NCT00795600|Secondary|Absolute Change in Hip Circumference|Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.|||cm||Standard Error|Least Squares Mean
2761584|NCT00795600|Secondary|Absolute Change in Waist Circumference|Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.|||cm||Standard Error|Least Squares Mean
2761585|NCT00795600|Secondary|Absolute Change in Body Weight|Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.|||kg||Standard Error|Least Squares Mean
2761586|NCT00795600|Secondary|Absolute Change in Potassium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.|||mmol/L||Standard Deviation|Mean
2761587|NCT00795600|Secondary|Absolute Change in Sodium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.|||mmol/L||Standard Deviation|Mean
2761588|NCT00795600|Secondary|Absolute Change in Alkaline Phosphatase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.|||IU/L||Standard Deviation|Mean
2761589|NCT00795600|Secondary|Absolute Change in Aspartate Aminotransferase (ASAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.|||IU/L||Standard Deviation|Mean
2761590|NCT00795600|Secondary|Absolute Change in Alanine Aminotransferase (ALAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.|||IU/L||Standard Deviation|Mean
2761591|NCT00795600|Secondary|Absolute Change in Bilirubin Total||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.|||mg/dL||Standard Deviation|Mean
2761592|NCT00795600|Secondary|Absolute Change in Albumin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.|||mg/dL||Standard Deviation|Mean
2761593|NCT00795600|Secondary|Absolute Change in Urea||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.|||mg/dL||Standard Deviation|Mean
2761596|NCT00795600|Secondary|Absolute Change in Basophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||10^9 cells/L||Standard Deviation|Mean
2761597|NCT00795600|Secondary|Absolute Change in Eosinophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||10^9 cells/L||Standard Deviation|Mean
2761598|NCT00795600|Secondary|Absolute Change in Neutrophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||percentage||Standard Deviation|Mean
2761599|NCT00795600|Secondary|Absolute Change in Monocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
2761600|NCT00795600|Secondary|Absolute Change in Lymphocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
2761601|NCT00795600|Secondary|Absolute Change in Leucocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.|||10^9 cells/L||Standard Deviation|Mean
2761602|NCT00795600|Secondary|Absolute Change in Erythrocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.|||percentage||Standard Deviation|Mean
2761603|NCT00795600|Secondary|Absolute Change in Thrombocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
2761604|NCT00795600|Secondary|Absolute Change in Blood Volume (Haematocrit)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.|||percentage||Standard Deviation|Mean
2761605|NCT00795600|Secondary|Absolute Change in Haemoglobin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.|||g/dL||Standard Deviation|Mean
2761606|NCT00795600|Secondary|Absolute Change in Free Fatty Acids||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.|||mg/dL||Standard Deviation|Mean
2761607|NCT00795600|Secondary|Absolute Change in Triglycerides||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.|||mg/dL||Standard Deviation|Mean
2761608|NCT00795600|Secondary|Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
2761609|NCT00795600|Secondary|Absolute Change in Low Density Lipoprotein (LDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
2761610|NCT00795600|Secondary|Absolute Change in High Density Lipoprotein (HDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
2761611|NCT00795600|Secondary|Absolute Change in Total Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
2761612|NCT00795600|Secondary|Absolute Change in Adiponectin|Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.|||mcg/dL||Standard Error|Least Squares Mean
2761637|NCT00795535|Primary|SDNN: Standard Deviation of the Normal-to-normal R-R Interval|A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.|Upon arrival to the hospital||||milliseconds (ms)||Standard Deviation|Mean
2761613|NCT00795600|Secondary|Absolute Change in Fasting Plasma Glucose (FPG)|Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.|||mg/dL||Standard Error|Least Squares Mean
2761614|NCT00795600|Secondary|Absolute Change in HbA1c (Glycosylated Haemoglobin)|Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2761615|NCT00795600|Secondary|Percentage Change in Liver/Spleen Attenuation Ratio|Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.|||percent change||Standard Error|Least Squares Mean
2761616|NCT00795600|Secondary|Absolute Change in Liver/Spleen Attenuation Ratio|Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.|||ratio||Standard Error|Least Squares Mean
2761617|NCT00795600|Secondary|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.|||percent change||Standard Error|Least Squares Mean
2761618|NCT00795600|Secondary|Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.|||ratio||Standard Error|Least Squares Mean
2761619|NCT00795600|Secondary|Percentage Change in Subcutaneous Adipose Tissue Area|Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.|||percent change||Standard Error|Least Squares Mean
2761620|NCT00795600|Secondary|Absolute Change in Subcutaneous Adipose Tissue Area|Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.|||cm^2||Standard Error|Least Squares Mean
2761621|NCT00795600|Secondary|Percentage Change in Visceral Adipose Tissue Area|Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.|||percent change||Standard Error|Least Squares Mean
2761622|NCT00795600|Secondary|Absolute Change in Visceral Adipose Tissue Area|Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.|||cm^2||Standard Error|Least Squares Mean
2761623|NCT00795600|Secondary|Percentual Change in Calculated Trunk Fat Percentage|Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.|||percent change||Standard Error|Least Squares Mean
2761624|NCT00795600|Secondary|Absolute Change in Calculated Trunk Fat Percentage|Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.|||percent of trunk fat (%)||Standard Error|Least Squares Mean
2761625|NCT00795600|Secondary|Percentual Change in Calculated Whole Body Fat Percentage|Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.|||percent change||Standard Error|Least Squares Mean
2761626|NCT00795600|Secondary|Absolute Change in Calculated Whole Body Fat Percentage|Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.|||percent of whole body fat (%)||Standard Error|Least Squares Mean
2761627|NCT00795600|Secondary|Percentage Change in Trunk Lean Mass|Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.|||percent change||Standard Error|Least Squares Mean
2761628|NCT00795600|Secondary|Absolute Change in Trunk Lean Mass|Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
2761629|NCT00795600|Secondary|Percentage Change in Whole Body Lean Mass|Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.|||percent change||Standard Error|Least Squares Mean
2761630|NCT00795600|Secondary|Absolute Change in Whole Body Lean Mass|Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
2761631|NCT00795600|Secondary|Percentage Change in Whole Body Fat Mass|Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.|||percent change||Standard Error|Least Squares Mean
2761632|NCT00795600|Secondary|Absolute Change in Whole Body Fat Mass|Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
2761633|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.|||grams (g)||Standard Error|Least Squares Mean
2761634|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
2761635|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.|||percent change||Standard Error|Least Squares Mean
2761636|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.|||percent change||Standard Error|Least Squares Mean
2761638|NCT00795535|Primary|Life Saving Intervention in the Operating Room.|A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
2761639|NCT00795535|Primary|Serious Injury|A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
2761640|NCT00795535|Primary|Base Deficit </= -6|Indicator for volume deficit and resuscitation. Number of participants with Base Deficit </= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit </= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
2761641|NCT00795509|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.|||participants|||Number
2761642|NCT00795509|Primary|Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.|||participants|||Number
2761643|NCT00795366|Primary|Time ICP >20|The number of hours that participants remained with intracranial pressure above 20 mmHg|The number of hours during the first 5 days of intracranial pressure monitoring|Intent-to-Treat|||Hours||Standard Deviation|Mean
2761644|NCT00795340|Secondary|Objective Tumor Response as Assessed by RECIST Criteria v1.1.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|ITT|||percentage of participants||95% Confidence Interval|Number
2761645|NCT00795340|Secondary|Progression-free Survival|Medians of PFS and their confidence intervals by arm|at every 3 months visit throughout trial, a median of 12 months|ITT|||months||95% Confidence Interval|Median
2761646|NCT00795340|Primary|Overall Survival|Medians of survival time, and their confidence intervals.|at every 3 months visit throughout trial, a median of 13.1 months.|ITT|||months||95% Confidence Interval|Median
2761647|NCT00795288|Secondary|Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk|Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.|7-10 days after hemorrhage||||ratio||Standard Deviation|Mean
2761648|NCT00795288|Primary|Cerebral Autoregulation During Peak Period of Vasospasm Risk|Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.|7-10 days after hemorrhage||||participants|||Number
2761649|NCT00795288|Primary|Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk|Resting cerebral blood flow during peak period of vasospasm risk measured by PET|7-10 days after hemorrhage|"Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.~be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons"|||mL/100 g/min||Standard Deviation|Mean
2761650|NCT00795236|Primary|To Determine the Efficacy of Melatonin Treatment in Entraining Blind Free-running Children and Young Adults, a Binomial Test Will be Used.||Approximately 1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2761651|NCT00795236|Primary|To Test for a Proportional Difference in Circadian Status (Free-running Versus Entrained) Between Pre and Post- Pubertal Males in Blind Boys and Young Men, a Chi-square Test of Significance Will be Used for Each Age Group.||Approximately 1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2761652|NCT00795236|Primary|To Test for a Proportional Gender Difference in Circadian Status (Free-running Versus Entrained) in Blind Children and in Adolescents, a Chi-square Test of Significance Will be Used for Each Age Group.||Approximately 1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2761653|NCT00795210|Secondary|Insulin Sensitivity|"insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; M value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given"|after two weeks treatment|Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.|||mg/kg/min||Standard Deviation|Mean
2761672|NCT00795132|Secondary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation.|24 months|All enrolled participants were analyzed.|||probability||Standard Error|Mean
2762778|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
2761654|NCT00795210|Primary|Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug|Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.|after 2 weeks treatment|Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.|||ng/mL||Inter-Quartile Range|Median
2761655|NCT00795184|Primary|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.|Centralized histopathology confirmation within 4-6 weeks||||percentage of lesions|Participants|95% Confidence Interval|Number
2761656|NCT00795145|Secondary|Cohort 2: Number of Subjects With AEs and SAEs|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|SAS|||participants|||Number
2761657|NCT00795145|Secondary|Cohort 2: Vss|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||L/kg||Standard Deviation|Mean
2761658|NCT00795145|Secondary|Cohort 2: CL|Drug clearance = Dose / AUC inf|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||mL/min/kg||Standard Deviation|Mean
2761659|NCT00795145|Secondary|Cohort 2: Tmax and t1/2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax.|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||hr||Full Range|Median
2761660|NCT00795145|Secondary|Cohort 2: Cmax||Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
2761661|NCT00795145|Secondary|Cohort 2: AUC Inf and AUC Last|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||ug *hr/mL||Standard Deviation|Mean
2761662|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population|||msec|||Number
2761663|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population|||msec|||Number
2761664|NCT00795145|Primary|Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo|The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia's formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|The pharmacokinetic (PK) parameter analysis population was defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliseconds (msec)|||Number
2761665|NCT00795145|Secondary|Cohort 1: Steady-State Volume of Distribution (Vss)|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||L/kg||Standard Deviation|Mean
2761666|NCT00795145|Secondary|Cohort 1: Clearance of Linezolid (CL)|Drug clearance = Dose / AUC inf|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||mL/minute (min)/kilogram (kg)||Standard Deviation|Mean
2761667|NCT00795145|Secondary|Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||hr||Full Range|Median
2761668|NCT00795145|Secondary|Cohort 1: Maximum Observed Plasma Concentration (Cmax)||predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
2761669|NCT00795145|Secondary|Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||microgram (ug)*hours (hr)/mL||Standard Deviation|Mean
2761670|NCT00795145|Primary|Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|Safety Analysis Set (SAS): All subjects who received at least 1 dose of study medication.|||participants|||Number
2761671|NCT00795132|Secondary|Number of Participants Who Experienced Transplantation-related Mortality (TRM)|Cumulative incidence transplantation-related mortality (TRM)|24 months|All incidences of enrolled patients were analyzed.|||participants|||Number
2761690|NCT00794677|Other Pre-specified|Percent Change of Apolipoprotein B||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
2761673|NCT00795132|Primary|Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments|Assessed donor engraftment in very high risk pediatric patients.|24 months|All enrolled patients were analyzed except for the 3 patients who relapsed or died prior to engraftment.|||participants|||Number
2761674|NCT00795002|Secondary|Disease-free Survival|This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.|up to 2 years|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy.|||months||95% Confidence Interval|Median
2761675|NCT00795002|Secondary|Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM|Toxicity defined as death from any cause within 60 days of starting FLAM.|60 days|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. Toxicity defined as death from any cause within 60 days of starting FLAM.|||Participants|||Count of Participants
2761676|NCT00795002|Primary|Complete Response|Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.|1 year|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy|||participants|||Number
2761677|NCT00794963|Primary|Change in Weight||baseline and 8 months|4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up|||pounds||Standard Deviation|Mean
2761678|NCT00794950|Secondary|Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib|"Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to characterize the toxicity: Toxic events are listed by name, body system and grade.~Note: to fit within character length constraints, 3 below means Grade 3; and S & S means Skin and Subcutaneous system."|26 months|All participants were followed, by permission, even those who withdrew from full treatment.|||Participants|||Count of Participants
2761679|NCT00794950|Secondary|Recurrence-free Survival at 2 Years in Patients With Intact Bladder.||2 years||||percentage of participants||95% Confidence Interval|Number
2761680|NCT00794950|Secondary|Percentage of Participants Who Experienced a Complete Response at 6 Months, Following Study Regimen.|Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)|28 weeks||||Participants|||Count of Participants
2761681|NCT00794950|Primary|Number of Participants With Complete Response at 3 Months|Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)|14 weeks||||Participants|||Count of Participants
2761682|NCT00794924|Secondary|Improvement in Nutritional and Immunological Measurements||45 days|||||||
2761683|NCT00794924|Primary|Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group|Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.|45 days of measuring the outcome|The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol.|||days of constipation or diarrhea||Standard Deviation|Mean
2761684|NCT00794820|Secondary|Overall Survival (OS) Rate|OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants is not included in analysis, the participant went off study after two months of treatment.|||Percentage of Participants|||Number
2761685|NCT00794820|Secondary|Remission Duration/Time to Progression (TTP)|TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.|||Months||Full Range|Median
2761686|NCT00794820|Primary|Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months|CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD.|6 months|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.|||Percentage of Participants|||Number
2761687|NCT00794677|Other Pre-specified|Percent Change of Non-high Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
2761688|NCT00794677|Other Pre-specified|Percent Change in High Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
2761689|NCT00794677|Other Pre-specified|Percent Change of Low Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
2761691|NCT00794677|Other Pre-specified|Log (AUC of Plasma Triglyceride) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, one subject eliminated because the AUC was negative and cannot be log transformed|||Log(mg/dl)||Standard Error|Mean
2761692|NCT00794677|Other Pre-specified|Log (AUC of Plasma Total Cholesterol) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, restricted to changes that were nonnegative because there is no log for a negative number|||Log(mg/dl)||Standard Error|Mean
2761693|NCT00794677|Other Pre-specified|Log(Fasting Plasma Levels of Diet-derived Oxysterols (7-ketocholesterol))||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||Log(mg/dl)||Standard Error|Mean
2761694|NCT00794677|Secondary|Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus|Log Cmax of 7 ketocholesterol after an oral bolus in patients with primary hypercholesterolemia.|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol|||Log(mg/dl)||Standard Error|Mean
2761695|NCT00794677|Primary|Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus|Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|per protocol|||Log(mg/dl)||Standard Error|Mean
2761696|NCT00794664|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761697|NCT00794664|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761698|NCT00794664|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761699|NCT00794664|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761700|NCT00794664|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||ratio||Inter-Quartile Range|Median
2761701|NCT00794664|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2761702|NCT00794664|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761703|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761704|NCT00794664|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761717|NCT00794573|Secondary|Reduction in Daily Cigarette Consumption by 50% or Greater||12 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.|||Participants|||Count of Participants
2762823|NCT00788827|Secondary|Amylase Level|Each participant had mean amylase data analysed to give a pre and post mean result|12 weeks|Participants who received a stem cell infusion|||units/L||Standard Deviation|Mean
2761705|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761706|NCT00794664|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761707|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761708|NCT00794664|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761709|NCT00794664|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761710|NCT00794664|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761711|NCT00794664|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761712|NCT00794664|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761713|NCT00794664|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2761714|NCT00794664|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2761715|NCT00794664|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.|||percentage of baseline||Standard Deviation|Mean
2761716|NCT00794573|Secondary|Reduction in Daily Cigarette Consumption by 50% or Greater||4 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.|||Participants|||Count of Participants
2761718|NCT00794573|Secondary|Reduction in Daily Cigarette Consumption by 50% or Greater||24 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.|||Participants|||Count of Participants
2761719|NCT00794573|Secondary|Reduction in Daily Cigarette Consumption by 50% or Greater||52 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.|||Participants|||Count of Participants
2761720|NCT00794573|Secondary|Continuous Smoking Abstinence|Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 4.|4 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761721|NCT00794573|Secondary|7-Day Point Prevalence Smoking Abstinence|7-day point prevalence abstinence at week 4, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm|4 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761722|NCT00794573|Secondary|Continuous Smoking Abstinence|Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 12.|12 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761723|NCT00794573|Secondary|7-Day Point Prevalence Smoking Abstinence|7-day point prevalence abstinence at week 12, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm|12 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761724|NCT00794573|Secondary|Continuous Smoking Abstinence|Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 52.|52 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761725|NCT00794573|Secondary|7-Day Point Prevalence Smoking Abstinence|7-day point prevalence abstinence at week 52, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm|52 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761726|NCT00794573|Primary|Continuous Smoking Abstinence|Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 24.|24 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761727|NCT00794573|Primary|7-Day Point Prevalence Smoking Abstinence|7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm|24 weeks|Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.|||Participants|||Count of Participants
2761728|NCT00794560|Secondary|Patient Satisfaction||at the end of the individual drug therapy, an average of 18 days|||||||
2761729|NCT00794560|Secondary|Compliance|objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).|at the end of the individual drug therapy, an average of 18 days||||percentage of syringes||Standard Deviation|Mean
2761730|NCT00794560|Primary|Drug Use Problems|During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.|during the individual drug therapy, an average of 18 days||||scores on a scale||Standard Deviation|Mean
2761731|NCT00794547|Other Pre-specified|To Correlate the Pharmacokinetic Parameters of Systemic Calcitriol Exposure (AUC) With SNPs of the 24-hydroxylase (CYP24), the Major Vitamin D3 Inactivating Enzyme.||3-6 months|||||||
2761732|NCT00794547|Secondary|Mean AUC 1,25-D3 Concentration at 12 and 24 Hours|The mean AUC (area under the curve) concentrations of 1,25-D3 from 0-12 hours and 0-24 hours will be calculated.|12 and 24 hours post dose|Patients from the phase II portion of the study were included in the pharmacokinetics analysis|||h*ng/mL||Standard Error|Mean
2761733|NCT00794547|Primary|Median Overall Survival|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, overall survival was determined.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.|||months||95% Confidence Interval|Median
2761734|NCT00794547|Primary|Median Time to Progression|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, median time to progression was determined. Progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.|||months||95% Confidence Interval|Median
2761735|NCT00794547|Primary|Number of Participants That Experience Grade 3 or Greater Neutropenia|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. Toxicity was assessed, in part, by noting the number of participants that experience grade 3 or greater neutropenia in each phase of the trial. Toxicities were recorded using NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and were followed for 30 days after the date of withdrawal from study drug.|30 days after last dose|Thirty-four patients were enrolled (18 in phase I and 16 in phase II). 16 of 18 patients enrolled in the Phase 1 portion of the study were evaluable for toxicity. One patient in the phase II study went to another therapy prior to the 30 day window for a confirmatory scan and was thus excluded from analysis.|||participants|||Number
2761736|NCT00794547|Primary|MTD of Intravenous Calcitriol When Administered Prior to Fixed Dose Cisplatin 75mg/m2 and Docetaxel 75 mg/m2, Every 3 Weeks in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)|The primary objective was to determine the Maximum Tolerated Dose (MTD) of intravenous calcitriol when administered prior to fixed dose cisplatin 75mg/m2 and docetaxel 75 mg/m2, every 3 weeks in patients with advanced non-small cell lung cancer (NSCLC). Accrual duration for the study is 5 years.|5 years|Eighteen patients were enrolled, and 16 were evaluable for toxicity assessments. Two patients were not evaluable as they progressed prior to completion of cycle 1.|||mcg/m^2|||Number
2761737|NCT00794508|Secondary|Number of Participants Reaching the Normal Range of ADA Enzyme Activity|As measured by ADA enzyme activity in peripheral blood mononuclear cells|2 years||||participants|||Number
2761738|NCT00794508|Secondary|Number of Participants With Greater Than 1% of Gene-Modified Cells in the Peripheral Blood|As measured by quantitative polymerase chain reaction in peripheral blood cells separated into mononuclear and granulocyte fractions.|2 years||||participants|||Number
2761739|NCT00794508|Primary|Number of Participants With Adverse Events|"Examine the safety of the procedure: harvesting bone marrow, isolating CD34+ hematopoietic stem/progenitor cells, performing ex vivo gene transduction with the MND-ADA gamma-retroviral vector, giving 90 mg/m2 busulfan to make space in the bone marrow to aid engraftment, and re-infusing the autologous gene-modified cells."|2 years||||participants|||Number
2761740|NCT00794469|Primary|Baseline Metabolic Rate|baseline metabolic rate|baseline||||kcal/d||Standard Deviation|Mean
2761741|NCT00794469|Primary|Post-drinking Metabolic Rate|resting metabolic rate after drinking water|1 hour||||kcal/d||Standard Deviation|Mean
2761742|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12|"Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study."|Week 12|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
2761743|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8|"Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study."|Week 8|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
2761744|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4|"Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study."|Week 4|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
2761745|NCT00794313|Secondary|Modified Abnormal Involuntary Movement Scale Area Under the Curve|Area under the curve computed for whole body (total) mAIMS (Modified Abnormal Involuntary Movement Scale) scores at each time measurement. This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms). All body parts are rated separately on this 0 (none) to 4 (severe - markedly impairs activities) scale. Thus, the total score can range from 0 - 28 with 28 indicating the most severe LID. mAIMS ratings occur as the subject performs the cognitive task while standing on the force plate. mAIMS ratings are made every half hour during the levodopa (LD) dose cycle.|Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)||||Units on a Scale * Hours||Standard Deviation|Mean
2761746|NCT00794313|Primary|Forceplate AUC|Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.|Every 1/2 hour for 8 hour levodopa cycle|triple cross-over study design.|||(meters/second)*hours||Standard Deviation|Mean
2761747|NCT00794196|Secondary|Patient Wellbeing|"Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life.~The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health."|0, 3 and 6 months||||units on a scale||95% Confidence Interval|Mean
2761748|NCT00794196|Primary|Adherence to Antidepressant Medication|Adherence to antidepressant medication was measured through Pharmacy records|At 3 and 6 months||||percentage of adherence patients||95% Confidence Interval|Number
2761760|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 9|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
2761749|NCT00794170|Primary|Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)|The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.|Baseline and 12 months|The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.|||participants|||Number
2761750|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|Prior to last dose at Week 12 (Day 84)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2761751|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 8 (Day 57)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2761752|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 4 (Day 29)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2761753|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 2 (Day 15)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2761754|NCT00794157|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|End of treatment (Week 12 + 1 day, Day 85)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2761755|NCT00794144|Primary|Number of Participants With Anatomic Nasal Exam Abnormalities|The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa|Day 1 (Baseline) to Exit||||Participants|||Number
2761756|NCT00794118|Secondary|Indirect Costs|Indirect costs represent the loss of resources as a consequence of work disability or unemployment.|Baseline, Months 3, 6, 9 and 12|There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.||||||
2761757|NCT00794118|Secondary|Direct Costs|Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.|Baseline, Months 3, 6, 9 and 12|There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.||||||
2761758|NCT00794118|Primary|36-Item Short-Form Health Survey (SF-36) at Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
2761759|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 12|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
2762824|NCT00788827|Secondary|Insulin Level|Mean insulin requirement was calculated for each participant pre and post stem cell infusion|12 weeks|Participants who received a stem cell infusion|||iu/day||Standard Deviation|Mean
2761761|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 6|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
2761762|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 3|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
2761763|NCT00794118|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||minutes||Standard Deviation|Mean
2761764|NCT00794118|Primary|Duration of Morning Stiffness at Month 9|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
2761765|NCT00794118|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
2761766|NCT00794118|Primary|Duration of Morning Stiffness at Month 3|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
2761767|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
2761768|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761769|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761770|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761771|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 12|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
2761772|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 9|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761773|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 6|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761774|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 3|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761775|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
2761776|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761777|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761778|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761779|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
2761780|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 9|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761781|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761782|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 3|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
2761783|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||mm/hr||Standard Deviation|Mean
2761784|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 9|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
2761785|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
2761786|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 3|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
2761787|NCT00794118|Primary|C-reactive Protein (CRP) at Month 12|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||mg/dL||Standard Deviation|Mean
2761788|NCT00794118|Primary|C-reactive Protein (CRP) at Month 9|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
2761789|NCT00794118|Primary|C-reactive Protein (CRP) at Month 6|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
2761790|NCT00794118|Primary|C-reactive Protein (CRP) at Month 3|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
2761791|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 12|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
2761792|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 9|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761793|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 6|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761794|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 3|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761795|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
2761796|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 9|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761797|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761798|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 3|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761799|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 12|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
2761800|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 9|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761801|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 6|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761802|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 3|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
2761803|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
2761804|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
2761805|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
2761806|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
2761807|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).|||Percentage of participants|||Number
2761808|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
2761809|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
2761810|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.|Month 3|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
2761811|NCT00794040|Secondary|Anxiety Symptoms at 8th Week of Trial|Difference in anxiety symptoms at 8th week of trial as measured with the Pediatric Anxiety Rating Scale (PARS) with scores ranging 0-25. Higher values represent a worse outcome.|Collected weekly during the 8th week trial. The 8th-week outcome is reported.|Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.|||units on a scale||Standard Error|Mean
2761812|NCT00794040|Secondary|Depressive Symptoms at 8th Week of Trial|Difference in depressive symptoms at 8th week of trial as measured with Children's Depression Rating Scale (CDRS) with scores ranging 17-113, where scores >40 are considered over the clinical threshold, and scores <28 are considered within the healthy range.|Collected weekly during the 8th week trial. The 8th-week outcome is reported.|Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.|||units on a scale||Standard Error|Mean
2761813|NCT00794040|Secondary|Functional Impairment at 8th Week of Trial|Difference in functional impairment at 8th week of trial as measured with Children's Global Impression Scale (CGAS) with scores ranging from 1=Most impaired to 100=Not impaired at all.|Collected weekly during the 8th week trial. The 8th-week outcome is reported.|Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.|||units on a scale||Standard Error|Mean
2761814|NCT00794040|Secondary|Irritability Severity at 8th Week of Trial.|Clinical Global Impression-Severity (CGI-S): A measure of severity of irritability scale (from 1=Normal, not at all ill to 7=Among the most extremely ill patients).|Collected weekly during the 8th week trial. The 8th-week outcome is reported.|Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.|||units on a scale||Standard Error|Mean
2761815|NCT00794040|Primary|"Percentage of Participants That Much Improved (Score of 2) in, or Completely Recovered (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I)."|"A measure of change of irritability severity taking the baseline before randomization as a reference. Scores range 1 to 8, in which 1=Completely recovered,... 5=Unchanged,... 8=Much worse.~Percentage of participants who responded are based on an estimation and might not match exactly with discrete numbers of participants based on the denominator."|Collected weekly during the 8-week trial. The 8th-week outcome is reported.|Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants|||estimated percentage of participants|||Number
2761816|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
2761817|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|3 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
2761818|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|day 1 postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
2761819|NCT00793910|Secondary|Occurence of Use of Rescue Medication|Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured|2 hours to 4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||# of times rescue meds were used||Standard Deviation|Mean
2761820|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|2 hours postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
2761821|NCT00793871|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).|Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)|Safety analysis set included all participants who started study treatment.|||participants|||Number
2761822|NCT00793871|Secondary|Number of Participants With Significant Vital Signs Changes From Baseline|Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline.|Baseline (Day 1) up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
2761823|NCT00793871|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination.|Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
2761824|NCT00793871|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
2761825|NCT00793871|Other Pre-specified|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.|Baseline (Day 1) to tumor response (up to 82 weeks)|All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.|||weeks||95% Confidence Interval|Median
2761826|NCT00793871|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.|Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)|Safety analysis set included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
2761827|NCT00793871|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline (Day 1) up to end of study treatment (up to 276 weeks)|The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.|||% of participants||95% Confidence Interval|Number
2761828|NCT00793871|Secondary|Overall Survival (OS)|"OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.~In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive."|Baseline (Day 1) to death (up to 282 weeks)|Safety analysis set included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
2761829|NCT00793871|Primary|Progression-free Survival (PFS)|PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)|Safety analysis included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
2761830|NCT00793819|Primary|Change in Nocturia Episodes||12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||episodes||Standard Deviation|Mean
2761831|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAauc data|||ratio||Geometric Coefficient of Variation|Geometric Mean
2761832|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAcmax data|||ratio||Geometric Coefficient of Variation|Geometric Mean
2761833|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2761834|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2761835|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2761836|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )|PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Vz/F,ss data|||L||Geometric Coefficient of Variation|Geometric Mean
2761837|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )|PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available CL/F,ss data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2761838|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)|PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available MRTpo,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
2761839|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available t1/2,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
2761840|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available AUCτ,ss data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2761841|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)|PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmin,ss data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2761842|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available tmax,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
2761843|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmax,ss data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2762825|NCT00788827|Secondary|Hba1C Data of Pre and Post Stem Cell Infusion|Mean HbA1c laboratory measurements pre and post stem cell infusion|12 weeks|Patients who were infused with stem cells|||percentage||Standard Deviation|Mean
2761844|NCT00793793|Secondary|PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)|PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2761845|NCT00793793|Secondary|PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)|PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||h||Geometric Coefficient of Variation|Geometric Mean
2761846|NCT00793793|Secondary|PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)|"PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).~."|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2761847|NCT00793793|Secondary|Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period|Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.|from day 1 and up to 4 weeks|TS|||percentage of participants discontinued|||Number
2761848|NCT00793793|Secondary|Occurrence of AEs, by Action Taken With Regard to Study Medication|Occurrence of AEs, by action taken with regard to study medication.|from day 1 and up to 4 weeks|TS|||percentage of participants|||Number
2761849|NCT00793793|Secondary|Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time|Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
2761850|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Quantification Over Time|Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
2761851|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Detection Over Time|Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
2761852|NCT00793793|Secondary|Sustained Virologic Response (SVR)|Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).|week 72|FAS|||percentage of responders|||Number
2761853|NCT00793793|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).|week 48|FAS|||percentage of responders|||Number
2761854|NCT00793793|Secondary|Complete EVR2 (cEVR2)|VL below the limit of detection at both 4 weeks and 12 weeks|week 4 and week 12|FAS|||percentage of responders|||Number
2761855|NCT00793793|Secondary|Complete EVR1 (cEVR1)|VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks|week 4 and week 12|FAS|||percentage of responders|||Number
2761856|NCT00793793|Secondary|Early Virologic Response (EVR)|Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)|week 12|FAS|||percentage of responders|||Number
2761857|NCT00793793|Secondary|Rapid Virologic Response (RVR)|Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.|week 4|FAS (as randomized)|||percentage of responders||95% Confidence Interval|Number
2761858|NCT00793793|Secondary|Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients|Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised) including patients with available viral load data.|||Log10 IU/mL||Inter-Quartile Range|Median
2761859|NCT00793793|Secondary|Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients|Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised)|||log10 IU/mL||Inter-Quartile Range|Median
2761860|NCT00793793|Primary|Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time|"Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.~ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT)."|Baseline and up to 4 weeks|TS|||participants with grade 3 or 4 abnormal|||Number
2761861|NCT00793793|Primary|Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period|Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|TS|||percentage of participants with SAEs|||Number
2761862|NCT00793793|Primary|Occurrence of Adverse Events (AEs) During BI201335 + Washout Period|Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.|||percentage of participants with AEs|||Number
2761890|NCT00793624|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761863|NCT00793793|Primary|Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)|Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).|Baseline and up to 4 weeks|Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.|||percentage of responders||95% Confidence Interval|Number
2761864|NCT00793780|Secondary|Change in Questionnaire on Craving for Sweet or Rich Foods Score|The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.|baseline and week 8||||units on a scale||Standard Deviation|Mean
2761865|NCT00793780|Secondary|LDL Cholesterol|Determined by standard enzymatic procedures|baseline and week 8||||mg/dL||Standard Deviation|Mean
2761866|NCT00793780|Secondary|Insulin Levels|Determined with a double-antibody radioimmunoassay|baseline and week 8||||microIU/mL||Standard Deviation|Mean
2761867|NCT00793780|Secondary|PANSS- Positive and Negative Symptom Scale|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
2761868|NCT00793780|Secondary|Fasting Serum Glucose Lab Values||baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
2761869|NCT00793780|Primary|Change in Body Weight From Baseline|Weight was measured with shoes off to the nearest 0.1 kg.|8 weeks||||kg||95% Confidence Interval|Mean
2761870|NCT00793650|Secondary|Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.|"CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.~Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour."|100 days after transplant|As per the protocol.|||participants|||Number
2761871|NCT00793650|Primary|Safety and Engraftment|Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.|Day 30 after transplant|As per the protocol|||days||Full Range|Median
2761872|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
2761873|NCT00793624|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.|||percentage of participants|||Number
2761874|NCT00793624|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2761875|NCT00793624|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
2761876|NCT00793624|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
2761877|NCT00793624|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
2761878|NCT00793624|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
2761879|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
2761880|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
2761881|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761882|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761883|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761884|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761885|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761886|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761887|NCT00793624|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761888|NCT00793624|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761889|NCT00793624|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761891|NCT00793624|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS|||Number of puffs||Standard Error|Mean
2761892|NCT00793624|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS|||L/min||Standard Error|Mean
2761893|NCT00793624|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761894|NCT00793624|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761895|NCT00793624|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761896|NCT00793624|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761897|NCT00793624|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761898|NCT00793624|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
2761899|NCT00793624|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
2761948|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761900|NCT00793624|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
2761901|NCT00793624|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
2761902|NCT00793624|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
2761903|NCT00793624|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
2761904|NCT00793624|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
2761905|NCT00793624|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
2761906|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761907|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2762335|NCT00791037|Secondary|Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT||Up to 2 year following the last infusion||||Participants|||Count of Participants
2761908|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761909|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761910|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761911|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761912|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761913|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761914|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761915|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761916|NCT00793624|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
2761917|NCT00793624|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
2761918|NCT00793624|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
2761919|NCT00793624|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
2761920|NCT00793624|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
2761921|NCT00793624|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
2761922|NCT00793624|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
2761931|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761923|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761924|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761925|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761926|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761927|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
2761928|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761929|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2761930|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
2765957|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24||||MPS DA/month||Standard Deviation|Mean
2761932|NCT00793624|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
2761933|NCT00793624|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
2761934|NCT00793611|Secondary|Patient Global Impression of Improvement|Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.|6-12 weeks after study initiation (@ completion of intervention)|ITT|||units on a scale||Standard Deviation|Mean
2761935|NCT00793611|Secondary|Change in Voiding Frequency Based on Voiding Diary|change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.|baseline and 6-12 weeks after study initiation|ITT change in mean number of voids/24 hours|||number of voids per 24 hours||Standard Deviation|Mean
2761936|NCT00793611|Primary|Change in Overactive Bladder Symptoms (Based on OABqSF)|Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.|baseline and approximately 6-12 weeks after study initiation|ITT|||units on a scale||Standard Deviation|Mean
2761937|NCT00793585|Secondary|The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).||baseline and 6 months|We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.|||Upro/cr (mg/g)||Standard Deviation|Mean
2761938|NCT00793585|Primary|Change in Renal Function as Measured With eGFR||baseline and 6 months||||eGFR(min/ml)||Standard Deviation|Mean
2761939|NCT00793572|Secondary|Number of Patients Surviving Overall|Number of subjects surviving two years post autologous transplant.|At 2 years after the autograft||||Participants|||Count of Participants
2761940|NCT00793572|Secondary|Number of Patients With Non-relapse Mortality|Number of subjects with non-relapse mortalities post allogeneic transplant.|200 and 365 days after allo||||Participants|||Count of Participants
2761941|NCT00793572|Secondary|Number of Patients With Toxicities Related to Bortezomib Maintenance Therapy|Number of subjects with toxicities related to bortezomib maintenance therapy post-transplant.|Up to 100 days after the autograft or allograft||||Participants|||Count of Participants
2761942|NCT00793572|Secondary|Number of Patients With Chronic GVHD|Number of subjects with classic chronic or chronic extensive GVHD post allogeneic transplant.|1 year post allo||||Participants|||Count of Participants
2761943|NCT00793572|Secondary|Number of Patients With Grade II-IV Acute GVHD|"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~- bilirubin 2.0 - 3.0 mg/100 mL~- bilirubin 3 - 5.9 mg/100 mL~- bilirubin 6 - 14.9 mg/100 mL~- bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|100 days post allo transplant||||Participants|||Count of Participants
2761944|NCT00793572|Primary|Number of Patients Surviving Progression-free|"Number of subjects surviving without progressive disease post-transplant.~Progressive disease criteria:~Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant.~Appearance of new lytic bone lesions or plasmacytomas."|At 2 years after the autograft||||Participants|||Count of Participants
2761945|NCT00793546|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761946|NCT00793546|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761947|NCT00793546|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761949|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761950|NCT00793546|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761951|NCT00793546|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761952|NCT00793546|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 24 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761953|NCT00793546|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761954|NCT00793546|Secondary|Progression Free Survival (PFS) Based on Investigator|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761955|NCT00793546|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety population included all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2761956|NCT00793546|Primary|Progression Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
2761957|NCT00793520|Primary|Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.|Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.|Week 0, 5, 7 and 12||||Kg||95% Confidence Interval|Mean
2761958|NCT00793520|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient's right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC|Weeks 0, 5, 7 and 12||||Pain Rating||95% Confidence Interval|Mean
2761959|NCT00793455|Secondary|Colorectal Cancer Screening Completion|"We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|6 months post randomization|Analysis was based on intention to treat.|||participants|||Number
2761960|NCT00793455|Primary|Colorectal Cancer Screening Completion.|"We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|3 months post randomization|Analysis was based on intention to treat.|||participants|||Number
2761961|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12|SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761962|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6|SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761963|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 12|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761964|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 6|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761965|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 12|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761966|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 6|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761967|NCT00793403|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761984|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
2761968|NCT00793403|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761969|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 12|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
2761970|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 6|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
2761971|NCT00793403|Primary|Patient's General Health Assessment at Month 12|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761972|NCT00793403|Primary|Patient's General Health Assessment at Month 6|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761973|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761974|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761975|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hour||Standard Deviation|Mean
2761976|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hr||Standard Deviation|Mean
2761977|NCT00793403|Primary|C-reactive Protein (CRP) at Month 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/dL||Standard Deviation|Mean
2761978|NCT00793403|Primary|C-reactive Protein (CRP) at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/dL||Standard Deviation|Mean
2761979|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 12|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761980|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 6|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761981|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
2761982|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
2761983|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
2761985|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 12|CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761986|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 6|CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761987|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761988|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761989|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 12|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761990|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 6|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761991|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761992|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2761993|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761994|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 6|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761995|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761996|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2761997|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Joints||Standard Deviation|Mean
2761998|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Joints||Standard Deviation|Mean
2761999|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2762000|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2762001|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2762002|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2762003|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12|Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2762004|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6|Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
2762005|NCT00793325|Primary|Change in Height SD Score for Calendar Age.|The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.|||standard deviation (SD) score||Standard Deviation|Mean
2762006|NCT00793325|Primary|Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.|Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.|||standard deviation (SD) score||Standard Deviation|Mean
2762007|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).|To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
2762008|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.|To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
2762009|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.|To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
2762010|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications|To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2762011|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2762012|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.|To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2762013|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2762014|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2762015|NCT00793325|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||events|||Number
2762016|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2762040|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group|Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2762017|NCT00793182|Primary|Percentage of Patients With Contrast-induced Nephropathy (CIN)|"Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration.~For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration."|Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration|One patient from the Ioversol arm was prematurely withdrawn just after contrast medium administration due to the discovery of a new brain mass. Consequently, no SCr measurement was performed for this patient and the primary outcome could not be analyzed.|||Participants|||Count of Participants
2762018|NCT00793169|Primary|The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.||6 hours|Analysis was per protocol.|||Participants|||Number
2762019|NCT00793104|Secondary|MRI Evaluation Score|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months||||units on a scale||Standard Deviation|Mean
2762020|NCT00793104|Secondary|International Knee Documentation Committee (IKDC) at 24 Months.|The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months||||units on a scale||Standard Deviation|Mean
2762021|NCT00793104|Secondary|Lysholm With Tegner Score|The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.|24 months||||units on a scale||Standard Deviation|Mean
2762022|NCT00793104|Secondary|Current Health Assessment|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months, MRI only at 12 and 24 months||||units on a scale||Standard Deviation|Mean
2762023|NCT00793104|Primary|The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months||||units on a scale||Standard Deviation|Mean
2762024|NCT00792948|Other Pre-specified|MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry|Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows.|Up to 5 years|||||||
2762025|NCT00792948|Other Pre-specified|Overall Survival (OS)|OS will be estimated using the method of Kaplan-Meier.|From the date of initial registration on the study until death from any cause, assessed up to 5 years|Analysis includes eligible patients who received treatment.|||Probability of surviving 12 months||95% Confidence Interval|Number
2762026|NCT00792948|Secondary|Continuous Complete Remission (CCR) Rate|Will be testing using an exact binomial test|18 months|Patients who had not received prior ALL therapy|||percentage of participants||95% Confidence Interval|Number
2762027|NCT00792948|Primary|Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation|Will be estimated using the method of Kaplan-Meier.|12 months|Patients who received allogeneic stem cell transplant|||Probability of 12-month RFS||95% Confidence Interval|Number
2762028|NCT00792935|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|"Hypoglycemic episodes are defined as either a fingerstick glucose~measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia."|Baseline to Week 6|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.|||participants|||Number
2762029|NCT00792935|Primary|Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose|"Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values."|Baseline and Week 6|The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).|||mg/dL||95% Confidence Interval|Least Squares Mean
2762030|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months|"100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.~50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.~Outcomes are reported at the community level because raw data could not be accessed.~There is no way to determine how many participants were examined in each arm."|3 years|We analyzed and reported the results of the trial at community level.|||community|community|Standard Deviation|Mean
2762039|NCT00792909|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2|ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2762031|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline|"Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.~The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination."|At baseline|"At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger.~Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania."|||community|community|Standard Deviation|Mean
2762032|NCT00792909|Secondary|Number (%) of Subjects With Serious Adverse Events|A serious adverse event (SAE) was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = occurrence of a SAE, regardless of relationship to vaccination.|During the 31-day period following vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2762033|NCT00792909|Secondary|Number (%) of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any = occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2762034|NCT00792909|Secondary|Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/ fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and Fever (rectal temperature ≥ 38.0 °C). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 drowsiness = drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = crying that could not be comforted/ prevented normal everyday activities. Grade 3 loss of appetite = not eating at all. Grade 3 fever = rectal temperature > 40.0°C.|During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2762035|NCT00792909|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed local symptoms were pain, redness and swelling. Any = occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = crying when limb was moved/ spontaneously painful. Grade 3 Redness/ Swelling = Redness/ swelling at injection site greater than (>) 30 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2762036|NCT00792909|Secondary|Number of Subjects With B-cells Detection in the Unprimed Group|Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.|Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants||Standard Deviation|Mean
2762037|NCT00792909|Secondary|Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2|Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.|Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants||Standard Deviation|Mean
2762038|NCT00792909|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group|ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2762171|NCT00791700|Secondary|Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48|Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.|Baseline to Week 24, Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug. Last Observation Carried Forward (LOCF) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2762041|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2|Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2762042|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762043|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762044|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762045|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762046|NCT00792909|Secondary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762047|NCT00792909|Secondary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762048|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2762944|NCT00787566|Secondary|Severity of Nausea Measured by a 4 Categorical Scale|4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)|24 hours|||||||
2762049|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2|Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2762050|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762051|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.2 μg/mL.|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762052|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762053|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL..|1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
2762054|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762055|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-additional dose at Month 34 in the current study (Month 34)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762172|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48|TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2762056|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) - in primary study (105539)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762057|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762058|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One week after dose 1 (Day 7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762059|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2762060|NCT00792805|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized to impute missing data.|||Liters||Standard Error|Least Squares Mean
2762061|NCT00792701|Other Pre-specified|Relationship Between RNA and Protein Expression of RRM1 and ERCC1||From time of registration to maximum of 2 years||||Scores||Full Range|Median
2762062|NCT00792701|Other Pre-specified|Generation of Results on in Situ Protein Expression and Other Assays for Genes Involved in Drug Efficacy||From time of registration to maximum of 2 years|Due to lack of funding, the protein expression data were never collected. Thus, this outcome could not be analyzed.||||||
2762063|NCT00792701|Other Pre-specified|Analytical Performance of the Biomarker Assay||From time of registration to maximum of 2 years|Due to lack of funding, the assay was never performed. Thus, this outcome could not be analyzed.||||||
2762064|NCT00792701|Secondary|Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.|RRM1 and ERCC1 protein levels are expressed as a simple score with no units.|From time of registration to maximum of 2 years|Protein expression relationships were analyzed in the overall patient population, and not by arm.|||Scores||Full Range|Median
2762065|NCT00792701|Secondary|Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0|Patients in the active monitoring arm were not followed for adverse events.|From time of registration to maximum of 2 years|"Number of Subjects With Greater Than Grade 2 Toxicity~Patients in the active monitoring arm were not followed for adverse events."|||participants|||Number
2762066|NCT00792701|Secondary|Two-year Disease-free Survival||From time of registration to maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
2762067|NCT00792701|Primary|Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting|Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|From time of registration to 84 days after surgical resection.|Percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|||Participants|||Count of Participants
2762068|NCT00792688|Secondary|Cosmesis/11-point Likert Scale|The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).|At 1 month following the initial treatment.||||scores on a scale||Standard Deviation|Mean
2762069|NCT00792688|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.|||days||Standard Deviation|Mean
2762070|NCT00792636|Secondary|Number of Participants Withdrawn From the Study Due to Blood Pressure Changes|The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
2762071|NCT00792636|Secondary|Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||days||Full Range|Median
2762072|NCT00792636|Secondary|Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||days||Full Range|Median
2762073|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg|The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
2762074|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study|The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
2762075|NCT00792636|Secondary|Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||participants|||Number
2762076|NCT00792636|Secondary|Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||participants|||Number
2762077|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
2762097|NCT00792571|Secondary|Number of Participants That Experienced Clinical Worsening During the Study|Number of Participants that experienced Clinical Worsening in the opinion of the Investigator. Clinical Worsening was defined as any of these events following the Baseline visit: Death, Transplantation or atrial septostomy, Clinical deterioration as defined by: Hospitalization as a result of PAH symptoms or Initiation of any new PAH specific therapy (e.g. ERA, PDE-5 inhibitor, prostanoid). All efficacy results are descriptive; no statistical analysis was conducted.|Up to 56 months||||Participants|||Count of Participants
2762945|NCT00787566|Secondary|Number of Emetic Episodes||24 hours|||||||
2762078|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
2762079|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
2762080|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
2762081|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Deviation|Mean
2762082|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Error|Mean
2762083|NCT00792636|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen|The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2762084|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Deviation|Mean
2762085|NCT00792623|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the active phase of the study (up to Month 24)|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered.|||Participants|||Count of Participants
2762086|NCT00792623|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered.|||Participants|||Count of Participants
2762087|NCT00792623|Secondary|Number of Subjects With Any and Related Rash|Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related).|During the 43-day (Days 0-42) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses.|||Participants|||Count of Participants
2762088|NCT00792623|Secondary|Number of Subjects With Any Fever|Any = fever equal to or greater than (≥) 37.5 °C. Grade 3 fever = fever above (>) 39.0 °C. Related = fever assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses.|||Participants|||Count of Participants
2762089|NCT00792623|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-vaccination period after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered. Five subjects who had not completed their symtpom sheets following dose 2 were not included in the analyses.|||Participants|||Count of Participants
2762090|NCT00792623|Secondary|Anti-varicella Antibody Titers|Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).|At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects. Only those subjects who provided a serum sample at the specified time point (i.e. with anti-VZV antibody assay results available) were included in the analysis.|||Titers||95% Confidence Interval|Geometric Mean
2762091|NCT00792623|Secondary|Number of Seropositive Subjects for Anti-varicella Antibodies|The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4.|At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects. Only those subjects who provided a serum sample at the specified time point (i.e. with anti-VZV antibody assay results available) were included in the analysis.|||Participants|||Count of Participants
2762092|NCT00792623|Secondary|Number of Subjects With a Varicella Vaccine Response|Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.|At 6.5 months post-transplantation = 2 months post first dose of vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 6.5 time point were available.|||Participants|||Count of Participants
2762093|NCT00792623|Primary|Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers|Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).|At 8 months post-transplantation = 1.5 months post-second dose of vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 8 time point were available.|||Titers||95% Confidence Interval|Geometric Mean
2762094|NCT00792623|Primary|Number of Subjects With a Varicella Vaccine Response|Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.|At 8 months post-transplantation = 1.5 months post-second dose of vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-varicella zoster virus (VZV) antibodies for Month 8 time point were available.|||Participants|||Count of Participants
2762095|NCT00792610|Primary|Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)|The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.|7 months||||participants|||Number
2762096|NCT00792571|Secondary|Number of Participants With a Change in WHO Functional Class|Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.|Baseline and 56 months||||Participants|||Number
2762133|NCT00791843|Primary|PP1- Serum IGF-1 Levels, DXA, Resting Metabolic Rate, Total Body Water, 3-D Echo, Cardiac MRI, Dobutamine Stress Echocardiogram, Ergometry, General Health Assessment, Physical Exam||baseline, 12, 18, and 30 weeks|Data unavailable for study, PI is deceased and all staff associated with study have left the institution.||||||
2762098|NCT00792571|Secondary|Change From Baseline in Borg Dyspnea Score at End of Study|The modified 0-10 category-ratio Borg scale consists of an 11-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) and 10 (for the worst condition) with nonlinear spacing of verbal descriptors of severity corresponding to specific numbers. The participant chose the number or the verbal descriptor to reflect presumed ratio properties of sensation or symptom intensity. Baseline was defined as the last non-missing evaluation preceding the first dose of study drug in study BPS-MR-PAH-201. Only participants with both a measurement at baseline and at the given visit are presented. All efficacy results are descriptive; no statistical analysis was conducted.|Baseline and 56 months|Only participants with both a measurement at baseline and at the given visit are presented.|||scores on a scale||Standard Deviation|Mean
2762099|NCT00792571|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study|"The area used for the Six Minute Walk Test (6MWT) was pre-measured at a minimum of 30 meters in length and at least 2 to 3 meters in width. There were no turns or significant curves to the 6-minute walk area. The length was marked with gradations to ensure the accurate measurement of the distance walked. The area was well ventilated with air temperature controlled at 20 to 23°C. Intermittent rest periods were allowed if the participant could no longer continue. If the participant needed to rest briefly, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called stop while simultaneously stopping the watch and then measured the distance walked. For the purposes of the 6MWT if a participant was assessed at Baseline using oxygen therapy, then all future 6MWT were conducted in the same manner. All efficacy results are descriptive; no statistical analysis was conducted."|Baseline and 56 months|Only participants with both a measurement at baseline and at the given visit are presented.|||meters||Standard Deviation|Mean
2762100|NCT00792571|Primary|Number of Treatment Emergent Adverse Events Reported During The Study|A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Up to 56 months||||TEAEs|||Number
2762101|NCT00792571|Primary|Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)|A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Up to 56 months||||Participants|||Count of Participants
2762102|NCT00792428|Secondary|Wolf-Motor-Function-Test|"The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed."|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days||||units on a scale (log(sec))||Standard Deviation|Mean
2762103|NCT00792428|Primary|Fugl-Meyer Assessment of Upper Extremity Motor Impairment|This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days||||units on a scale [0-66]||Standard Deviation|Mean
2762104|NCT00792298|Post-Hoc|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect)|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. In order to evaluate the efficacy of suvorexant on LPS excluding the influence of a carryover effect from Period 1 to Period 2, an ad hoc analysis of LPS restricted to Period 1 data was also performed.|Night 1 (Period 1 only) and end of Week 4 (Period 1 only)|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
2762105|NCT00792298|Secondary|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
2762106|NCT00792298|Secondary|LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2|WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
2762134|NCT00791817|Primary|Cmax|Maximum plasma concentration after a single dose|over 12 hours||||ng/mL||Standard Deviation|Geometric Mean
2762267|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762107|NCT00792298|Primary|LS Mean Sleep Efficiency (SE) During Periods 1 and 2|SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||percent of time in bed||Standard Error|Least Squares Mean
2762108|NCT00792259|Primary|Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device|"The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.~Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer"|30 Minutes||||µm||Standard Deviation|Mean
2762109|NCT00792116|Primary|Math Grades||14 week (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||average percentage correct||Standard Deviation|Mean
2762110|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS).|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|14 weeks (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||percentile||Standard Deviation|Mean
2762111|NCT00792116|Secondary|State Anxiety Scores on the State Trait Anxiety Index for Children (STAIC).|The STAIC is a scale that distinguishes between a situationally based anxiety and a general intrinsic inclination towards experiencing feelings of anxiety|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
2762112|NCT00792116|Secondary|Scores on the Math Anxiety Rating Scale for Adolescents (MARS-A)|he MARS-A (12) is a 98-item scale that lists various everyday situations in which adolescents may have to use mathematics.|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
2762113|NCT00792116|Secondary|Math Scores on the Woodcock Johnson III Tests of Achievement (WJ-III)|The WJ-III (10) is a standardized test battery used to assess an individual's academic strengths and weaknesses. For purposes of the current study, students were given the 4 math subtests of the WJ-III.|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
2762114|NCT00792116|Primary|Math Grades||baseline (the beginning of a school semester )|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||average percentage correct||Standard Deviation|Mean
2762115|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS)|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|the beginning of a school semester|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||percentile||Standard Deviation|Mean
2762116|NCT00792103|Secondary|Photophobia Free|Photophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participant|||Number
2762117|NCT00792103|Secondary|Phonophobia Free|Phonophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
2762118|NCT00792103|Secondary|Nausea Free|Nausea free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
2762119|NCT00792103|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch activation|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea).|||scores on a scale|Participants|Standard Deviation|Mean
2762120|NCT00792103|Secondary|Pain Relief|Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
2762121|NCT00791999|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
2762946|NCT00787566|Secondary|Time to Treatment Failure|Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first|24 hours|||||||
2762122|NCT00791999|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
2762123|NCT00791973|Secondary|Total Eye Symptom Scores After Antigen Challenge|Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe|After one week of treatment wtih veramyst or placebo||||units on a scale||Inter-Quartile Range|Median
2762124|NCT00791973|Primary|Change in Tryptase Level From Baseline to Post-antigen Challenge|Tryptase levels (mcg/L) were measured from nasal lavages|After one week of treatment wtih veramyst or placebo||||mcg/L||Inter-Quartile Range|Median
2762125|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|10 weeks|The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.|||scores on a scale||Standard Deviation|Mean
2762126|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 year|The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.|||scores on a scale||Standard Deviation|Mean
2762127|NCT00791934|Secondary|Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg|Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).|10 weeks post-procedure|The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.|||participants|||Number
2762128|NCT00791934|Secondary|Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)|The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.|10 weeks post surgery|The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.|||participants|||Number
2762129|NCT00791934|Primary|Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.|The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.|10 weeks post-procedure|A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.|||scores on a scale||Standard Deviation|Mean
2762130|NCT00791921|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
2762131|NCT00791921|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
2762132|NCT00791908|Primary|Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters|Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).|Baseline and 3 months||||Units on a scale||Full Range|Mean
2762947|NCT00787566|Secondary|Time to First Rescue Medication||24 hours|||||||
2762948|NCT00787566|Secondary|Time to First Emetic Episode||24 hours|||||||
2762135|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
2762136|NCT00791778|Other Pre-specified|EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
2762137|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
2762138|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
2762139|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
2762140|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
2762141|NCT00791778|Other Pre-specified|EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline|The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
2762142|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
2762143|NCT00791778|Other Pre-specified|EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
2762144|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
2762145|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
2762146|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
2762147|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
2762148|NCT00791778|Other Pre-specified|EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
2762149|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
2762150|NCT00791778|Other Pre-specified|FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
2762151|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
2762152|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
2762153|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
2762154|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
2762155|NCT00791778|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 1 (4 weeks per Cycle)/baseline|Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
2762156|NCT00791778|Secondary|Overall Survival (OS)|The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).|From randomization of the first patient until 32.5 months later|FAS=all randomized participants|||Days||95% Confidence Interval|Median
2762157|NCT00791778|Secondary|Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level|Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment|||Days||95% Confidence Interval|Median
2762158|NCT00791778|Primary|Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment|Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Full analysis set (FAS)=all randomized participants|||Days||95% Confidence Interval|Median
2762159|NCT00791765|Secondary|Patient Satisfaction With Treatment at Week 12|"This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from very dissatisfied to very satisfied) to indicate his or her level of satisfaction with the medication's control of psoriasis."|12 Weeks|Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.|||participants|||Number
2762160|NCT00791765|Secondary|Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12|Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.|||Percent change||Standard Error|Mean
2762949|NCT00787566|Secondary|Percentage of Patients Using Rescue Medications||24 hours|||||||
2762161|NCT00791765|Secondary|Percentage of Participants With PSSI 75% Response at Week 12|Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.|Baseline and Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
2762162|NCT00791765|Primary|Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12|The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 12|Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.|||Percent change||Standard Error|Mean
2762163|NCT00791700|Secondary|Percentage of Participants With Optimized Background Treatment Susceptibility Scores|Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, >=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and >=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.|48 weeks|The FAS consisted of all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2762164|NCT00791700|Secondary|Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF|Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.|48 weeks|"The FAS consisted of all participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||participants|||Number
2762165|NCT00791700|Secondary|Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48|Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.|Screening to Week 48|Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.|||participants|||Number
2762166|NCT00791700|Secondary|Number of Participants With Protocol Defined Virologic Failure|The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug.|||participants|||Number
2762167|NCT00791700|Secondary|Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48|Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Baseline, Week 24 and Week 48 post-treatment|"The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||percentage of CD4+ cells||Standard Deviation|Mean
2762168|NCT00791700|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48|Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Baseline, Week 24, Week 48 post-treatment|"The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||cells/mm^3||Standard Deviation|Mean
2762169|NCT00791700|Secondary|Change From Baseline in HIV-1 RNA (Log10 Copies/mL)|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Baseline, Week 24, Week 48 post-treatment|"The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Log10 Copies/mL||Standard Deviation|Mean
2762170|NCT00791700|Secondary|Change From Baseline in HIV-1 RNA (Original)|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Baseline, Week 24, Week 48 post-treatment|"The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||copies/mL||Standard Deviation|Mean
2762173|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].|Week 24 and Week 48 post-treatment|"The FAS consisted of all participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies the number of participants evaluable for this measure.Number analyzed signifies participants evaluable at specified time points for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2762174|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F].|Week 24 and Week 48 post-treatment|"The FAS consisted of all participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies the number of participants evaluable for this measure.Number analyzed signifies participants evaluable at specified time points for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2762175|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach|"The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure."|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2762176|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach|"The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure."|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who receive at least one dose of study medication.|||percentage of participants|||Number
2762177|NCT00791700|Primary|Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug|The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.|Baseline up to 5 years|Safety analysis was performed on all participants who received at least 1 dose of study drug.|||participants|||Number
2762178|NCT00791700|Primary|Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)|Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.|Baseline up to 5 years|Safety analysis was performed on all participants who received at least 1 dose of study drug.|||events|||Number
2762179|NCT00791700|Primary|Time to Reach Maximum Plasma Concentration (Tmax)||Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|"PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. Number analyzed signifies participants evaluable at specified time points for this outcome measure."|||hour||Full Range|Median
2762180|NCT00791700|Primary|Area Under the Curve at Steady State (AUCtau)|AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|"PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. Number analyzed signifies participants evaluable at specified time points for this outcome measure."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2762181|NCT00791700|Primary|Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)|Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|"PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. Number analyzed: participants evaluable at specified time points for this measure."|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2762182|NCT00791661|Secondary|24-hour Weighted Mean Glucose (WMG) Concentration|Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.|Up to 36 hours|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||mg/dL||95% Confidence Interval|Least Squares Mean
2762950|NCT00787566|Secondary|Percentage of Patients With Failure|Failure: > 5 emetic episodes|24 hrs|||||||
2762951|NCT00787566|Secondary|Percentage of Patients With Minor Control of Emesis|Minor Control of emesis: 3-5 emetic episodes|24 hrs|||||||
2762183|NCT00791661|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|up to approximately 17 days|Participants who received study drug. The same participant may appear in more than one treatment arm.|||participants|||Number
2762184|NCT00791661|Secondary|Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006|The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||hours||Standard Deviation|Mean
2762185|NCT00791661|Secondary|Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||hours||Full Range|Median
2762186|NCT00791661|Secondary|Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM||Standard Deviation|Mean
2762187|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006|AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM*hr||Standard Deviation|Mean
2762188|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006|AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM*hr||Standard Deviation|Mean
2762189|NCT00791661|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)|Participants who received study drug. The same participant may appear in more than one treatment arm.|||participants|||Number
2762190|NCT00791648|Secondary|Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)|measurements of blood brain barrier disruption (S100 calcium-binding protein B)|anesthesia induction, ICU admission, and POD 1|This marker was only measured in a subset of the total study population, chosen at random.|||pg/ml||Inter-Quartile Range|Median
2762191|NCT00791648|Secondary|Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)|measurements of neuronal injury (ubiquitin C-terminal hydrolase-1)|anesthesia induction, ICU admission, and POD 1|This marker was only measured in a subset of the total study population, chosen at random.|||ng/ml||Inter-Quartile Range|Median
2762192|NCT00791648|Secondary|Urine Markers of Oxidative Stress: Isofurans||anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.|This marker was only measured in a subset of the total study population, chosen at random.|||(ng/ml)^2/1000||Inter-Quartile Range|Median
2762193|NCT00791648|Secondary|Urine Markers of Oxidative Stress: f2-Isoprostanes||anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.|This marker was only measured in a subset of the total study population, chosen at random.|||ng/mg creatinine||Inter-Quartile Range|Median
2762194|NCT00791648|Secondary|Plasma Markers of Oxidative Stress: Isofurans||anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.|This marker was only measured in a subset of the total study population, chosen at random.|||pg/ml||Inter-Quartile Range|Median
2762195|NCT00791648|Secondary|Plasma Markers of Oxidative Stress: f2-Isoprostanes||anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.|This marker was only measured in a subset of the total study population, chosen at random.|||pg/ml||Inter-Quartile Range|Median
2762196|NCT00791648|Secondary|Urine Markers of Renal Injury|tissue inhibitor metaloproteinase-2 x insulin-like growth factor binding protein-7|anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and Post op Day (POD) 1, 2, 3|This marker was only measured in a subset of the total study population, chosen at random.|||(ng/ml)^2/1000||Inter-Quartile Range|Median
2762197|NCT00791648|Secondary|Mitochondrial Function--PGC-1alpha RNA Expression|PGC-1alpha RNA expression|anesthesia induction and POD 1|This marker was only measured in a subset of the total study population, chosen at random.|||au||Inter-Quartile Range|Median
2762198|NCT00791648|Secondary|Mitochondrial Function--lactate / Pyruvate Ratio|lactate / pyruvate ratio|anesthesia induction, after CPB, and POD 1|This marker was only measured in a subset of the total study population, chosen at random.|||ratio||Inter-Quartile Range|Median
2762199|NCT00791648|Secondary|Mitochondrial Function--mtDNA Copy Number|mtDNA copy number|anesthesia induction and POD 1|This marker was only measured in a subset of the total study population, chosen at random.|||au||Inter-Quartile Range|Median
2762200|NCT00791648|Secondary|Number of Participants That Died||until postoperative hospital discharge (about 7 days)||||Participants|||Count of Participants
2762201|NCT00791648|Secondary|Number of Participants With Stroke||while in ICU (about 2 days)||||Participants|||Count of Participants
2762202|NCT00791648|Secondary|Liver Enzyme: Aspartate Aminotransferase Level||postoperative day 1||||units/liter||95% Confidence Interval|Median
2762203|NCT00791648|Secondary|Number of Participants Requiring Dialysis||while in ICU (about 2 days)||||Participants|||Count of Participants
2762204|NCT00791648|Primary|Number of Participants With Delirium||while in ICU (about 2 days)||||Participants|||Count of Participants
2762205|NCT00791648|Primary|Number of Participants With Acute Kidney Injury||postoperative day 2||||Participants|||Count of Participants
2762206|NCT00791557|Primary|The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease|Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.|Week 26|Subjects who completed all required transfusions of infliximab were analyzed.|||participants|||Number
2762207|NCT00791518|Secondary|Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups|The number of participants with the indicated affected medical conditions were counted.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
2762208|NCT00791518|Secondary|Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||puffs||Standard Error|Mean
2762209|NCT00791518|Secondary|Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||puffs||Standard Error|Mean
2762210|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
2762211|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
2762212|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
2762213|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
2762214|NCT00791518|Secondary|Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <50% and >=50% predicted|||points on a scale||Standard Error|Mean
2762215|NCT00791518|Secondary|Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <80% and >=80% percent predicted|||points on a scale||Standard Error|Mean
2762216|NCT00791518|Secondary|Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios|The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).|Day 1 of a 1-day study|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||participants|||Number
2762952|NCT00787566|Secondary|Percentage of Patients With Major Control of Emesis|Major Control of emesis = 2 emetic episodes|24 hrs|||||||
2762217|NCT00791518|Secondary|Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||percentage of participants|||Number
2762218|NCT00791518|Primary|Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||percentage of participants|||Number
2762219|NCT00791492|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included participants who received at least one dose of study medication.|||participants|||Number
2762220|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Holter Monitor Findings|Clinically significant Holter monitor findings included: atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (<30 beats), sustained ventricular tachycardia (>= 30 beats), sinus pause (RR >2.0 second, where RR=60/heart rate), ventricular premature contractions.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.|||participants|||Number
2762221|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.|||participants|||Number
2762222|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Echocardiography (ECHO) Findings|Clinically significant ECHO findings included: LV posterior wall thickness greater than or equal to (>=)13 mm, LV septal thickness >= 13 mm, right ventricular thickness >= 7 mm, ratio of peak mitral early diastolic and atrial contraction velocity (E/A ratio) >= 2, prime septal (E/E) >15, ejection fraction < 50 percent (%), E deceleration time <= 150 millisecond (ms), isovolumic relaxation time (IVRT) <= 70 ms, any valve thickening (> trace regurgitation in mitral, aortic, pulmonary, or tricuspid valves), abnormal respiratory variation of inferior vena cava, pericardial effusion.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||participants|||Number
2762223|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to Grade 3|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.|||participants|||Number
2762224|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|An Adverse Event (AE) was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug, up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.|||participants|||Number
2762225|NCT00791492|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2762226|NCT00791492|Secondary|Intraepidermal Nerve Fiber (IENF) Density|IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. It is used in diagnosing various neuropathic conditions.|Baseline|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||fibers/mm||Standard Deviation|Mean
2762227|NCT00791492|Secondary|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 6, Month 3, 6 and 12|NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||picogram/milliliter (pg/mL)||Full Range|Median
2762228|NCT00791492|Secondary|Change From Baseline in Troponin I Concentration at Week 6, Month 3, 6 and 12|Troponin I was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular [LV] wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||nanogram/milliliter (ng/mL)||Full Range|Median
2762229|NCT00791492|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6 and 12|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
2762230|NCT00791492|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6 and 12|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
2762231|NCT00791492|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6 and 12|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
2762232|NCT00791492|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptoms present, 0=symptoms absent. Item 8-35:scored on 5-point Likert scale: 0=no problem,4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment,for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
2762233|NCT00791492|Secondary|Change From Baseline in Neuropathy Impairment Score - Lower Limb (NIS-LL) Score at Month 6 and 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
2762268|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762269|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762234|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2762235|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2762236|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2762237|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 6|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2762238|NCT00791479|Secondary|Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 8 weeks, 12 weeks|Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams [mg]) with evaluable pharmacokinetic data.|||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
2762239|NCT00791479|Secondary|Antibody Production and Effects to LY2189265|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 4 weeks, 12 weeks, 16 weeks|Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.|||participants|||Number
2762240|NCT00791479|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have body weight change from baseline data available.|||kilogram (kg)||Standard Error|Least Squares Mean
2762241|NCT00791479|Secondary|Treatment Emergent Adverse Events|A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug.|||participants|||Number
2762270|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762271|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762953|NCT00787566|Secondary|Percentage of Patients With Total Response|Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications|24 hours|||||||
2762242|NCT00791479|Secondary|Rate of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.|||Events per participant per year||Standard Error|Least Squares Mean
2762243|NCT00791479|Secondary|Number of Participants With Self-reported Hypoglycemic Events|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.|||participants|||Number
2762244|NCT00791479|Secondary|Change From Baseline in Blood Pressure (BP)|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood pressure change from baseline data available.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2762245|NCT00791479|Secondary|Change From Baseline in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have pulse rate change from baseline data available.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2762246|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Heart Rate|Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have heart rate change from baseline data available.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2762247|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.|||millisecond (msec)||Standard Error|Least Squares Mean
2762248|NCT00791479|Secondary|Change From Baseline in Insulin Sensitivity (HOMA2-%S)|Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
2762249|NCT00791479|Secondary|Change From Baseline in Beta-cell Function (HOMA2-%B)|Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
2762272|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762334|NCT00791037|Secondary|Development of CD4+ and CD8+ Epitope Spreading|As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.|Up to 2 years||||Participants|||Count of Participants
2762250|NCT00791479|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2762251|NCT00791479|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.|12 weeks|Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.|||percentage of participants|||Number
2762252|NCT00791479|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2762253|NCT00791479|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.|Baseline, 4 weeks, 8 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2762254|NCT00791479|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2762255|NCT00791388|Primary|t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14|t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14|over a Dosing Interval (τ = 12 Hours) on Day 14||||hours||Standard Deviation|Mean
2762256|NCT00791388|Primary|Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14|the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14|12 Hours on Day 14||||hours||Standard Deviation|Mean
2762257|NCT00791388|Primary|Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14|Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14|12 hours on Day 14||||ng/mL||Standard Deviation|Mean
2762258|NCT00791388|Primary|AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14|the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours|14 days|PG 760564 blood plasma concentrations were not measured for the placebo arm|||ng*h/mL||Standard Deviation|Mean
2762259|NCT00791336|Secondary|Safety and Tolerability of the Combined Treatment Regimen||7 weeks|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
2762260|NCT00791336|Secondary|Characterization of Overall and Disease-free Survival||long-term|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
2762261|NCT00791336|Primary|Pathologic Complete Response||30 days|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
2762262|NCT00791323|Primary|Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels|The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).|Day 3|Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.|||Picograms per milliliter (pg/ml)||Standard Deviation|Mean
2762263|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762264|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762265|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762266|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762273|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762274|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
2762275|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
2762276|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
2762277|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
2762278|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
2762279|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
2762280|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.|||Percentage of Participants|||Number
2762281|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
2762282|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
2762283|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762284|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762285|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762286|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762287|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
2762288|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
2762289|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
2762290|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
2762291|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762292|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762293|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762294|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762295|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762296|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762297|NCT00791258|Secondary|Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762298|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762299|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762300|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762301|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762302|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762303|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762304|NCT00791258|Secondary|Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||mm Hg||Standard Error|Mean
2762305|NCT00791258|Secondary|Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||mm Hg||Standard Error|Mean
2762306|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
2762307|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
2762308|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
2762309|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
2762310|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
2762311|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
2762312|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762313|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762314|NCT00791258|Secondary|Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762315|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
2762316|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of participants|||Number
2762317|NCT00791258|Secondary|Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||mm Hg||Standard Error|Mean
2762318|NCT00791258|Secondary|Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||mm Hg||Standard Error|Mean
2762319|NCT00791258|Secondary|The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks||Baseline to 12 and 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
2762320|NCT00791258|Secondary|The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
2762321|NCT00791258|Primary|The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
2762322|NCT00791128|Secondary|HbA1c Values at 12 Months||12 months||||HbA1c (%)||Standard Deviation|Mean
2762323|NCT00791128|Primary|% of Excess Weight Loss (EWL)|"Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight~% EWL = (baseline excess weight - weight loss) x 100"|12 months||||% excess weight loss||Standard Deviation|Mean
2762324|NCT00791102|Secondary|Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment||15 minutes prior to treatment and 15 minutes post antigen challenges||||L/min||Inter-Quartile Range|Median
2762325|NCT00791102|Primary|Change in Itching Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
2762326|NCT00791102|Primary|Change in Stuffy Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
2762327|NCT00791102|Primary|Change in Runny Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
2762328|NCT00791102|Secondary|Nasal Peak Inspiratory Flow Measurements|The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.|15 minutes after diluent challenge and 15 minutes after each antigen challenge||||L/min||Inter-Quartile Range|Median
2762329|NCT00791102|Primary|Change in Sneezing Symptom|Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||sneezes||Inter-Quartile Range|Median
2762330|NCT00791089|Primary|Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)|Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines|6 months||||Participants|||Count of Participants
2762331|NCT00791076|Secondary|Frequency of Hypoglycemia Defined as < 60 mg/dl.||72 hours|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Data, if collected,is unknown since no data are available.||||||
2762332|NCT00791076|Primary|Total Amount of Insulin Administered While on Placebo/PP.|Glucose values and the pattern of glycemic excursions over the 72 hour test period.|2 years|Data was not collected for this outcome measure. The P.I. left the institution and the study was terminated.||||||
2762333|NCT00791037|Secondary|Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)||Up to 2 years|Due to getting regulatory approvals we could only enroll 1 patient in this part of the protocol|||Participants|||Count of Participants
2762954|NCT00787566|Secondary|Percentage of Patients With Complete Response|Complete Response is defined as no emetic episodes and no use of rescue medications|24 hours|||||||
2762336|NCT00791037|Primary|Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0|Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.|Up to 4 months after first booster vaccine|The infusion of escalating doses of HER2 specific T cells will be defined as safe if at least 75% of subjects are able to receive all 3 infusions without dose limiting toxicity (DLT)|||participants|||Number
2762337|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352|ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762338|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352|ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762339|NCT00790933|Primary|Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762340|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762341|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762955|NCT00787566|Primary|Percentage of Patients With Complete Control|Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.|24 hours|ITT population|||Percentage|||Number
2762342|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762343|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762344|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762345|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762346|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762404|NCT00790907|Primary|Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period|The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
2767321|NCT00758602|Secondary|Participant and Graft Survival|The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.|Months 6 and 12|ITT population|||percentage of participants|||Number
2762347|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762348|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762349|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762350|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762351|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762357|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762352|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762353|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762354|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762355|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762356|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762399|NCT00790907|Secondary|Number of Participants With Major PCI-related Procedural Complications|Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.|During PCI procedure: immediately after randomization (approximately 10-75 minutes)|ITT Population|||participants|||Number
2762405|NCT00790868|Secondary|Role Functioning|LIFE-RIFT. For this clinician-rated measure, total scores range from 0 to 20, with higher scores indicating greater impairment|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized sample|||units on a scale||Standard Deviation|Mean
2762358|NCT00790933|Primary|Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28|EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762359|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352|ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762360|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352|ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762361|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762362|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762400|NCT00790907|Secondary|Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
2762401|NCT00790907|Secondary|Number of Participants With Minor Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
2762363|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762364|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762365|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762366|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762367|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762368|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762369|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762370|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762371|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762372|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762373|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762374|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762375|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762376|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762377|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762378|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762379|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762380|NCT00790933|Primary|Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28|The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762381|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352|ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762382|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300|ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.|||score on a scale||Standard Deviation|Mean
2762383|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762384|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762385|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762402|NCT00790907|Secondary|Number of Participants With Major Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
2762406|NCT00790868|Secondary|Quality of Life Ratings|Quality of life as assessed by the Q-LES-Q. Scores range from 14-70 for total raw score, higher scores indicate higher quality of life ratings.|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized participants|||units on a scale||Standard Deviation|Mean
2766435|NCT00763867|Other Pre-specified|MRI Aortic Thickness|A decrease in Aortic Thickness is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mm||Standard Deviation|Mean
2762386|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762387|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762388|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762389|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762390|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52|The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762403|NCT00790907|Secondary|Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR|ITT Population|||participants|||Number
2762407|NCT00790868|Secondary|Depression Severity|Depression severity was assessed with the MADRS, with scores ranging from 0 to 60. Higher scores indicate greater depression.|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized participants with panic disorder|||units on a scale||Standard Deviation|Mean
2762391|NCT00790933|Primary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28|The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28|Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.|||score on a scale||Standard Deviation|Mean
2762392|NCT00790933|Primary|Time to Major Inflammatory Bowel Disease (IBD) - Related Events|IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease.|Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)|Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement.|||weeks||95% Confidence Interval|Median
2762393|NCT00790933|Primary|Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings|A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.|From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)|The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.|||participants|||Number
2762394|NCT00790933|Primary|Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements|Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE.|From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)|The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.|||percentage of participants|||Number
2762395|NCT00790933|Primary|Number of Participants With Markedly Abnormal Safety Laboratory Findings|A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin <= 70 g/L, absolute lymphocyte count <0.5 X 10^9/L, leukocytes <2.0 X 10^9/L (absolute value), platelets <75.0 X 10^9/L, absolute neutrophil Count <1.0 X 10^9/L, prothrombin time >1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3.0 x ULN, aspartate aminotransferase (AST) >3.0 x ULN, bilirubin >2.0 x ULN, amylase >2.0 x ULN, lipase >2.0 x ULN.|From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)|The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.|||participants|||Number
2762396|NCT00790933|Primary|Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)|The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.|||percentage of participants|||Number
2762397|NCT00790907|Secondary|Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population|||participants|||Number
2762398|NCT00790907|Secondary|Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population|||participants|||Number
2767126|NCT00760266|Secondary|Percentage of Responders at Week 4 and Week 8|Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline|At 4 weeks and 8 weeks|Full analysis set|||Percentage of Participants|||Number
2762408|NCT00790868|Primary|Remission Status|"Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the CGI-S of 1 or 2 component of the remission status criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample."|Pre-treatment, Post-Treatment, and each follow-up sessions|Full sample of 180 randomized participants|||Participants|||Count of Participants
2762409|NCT00790868|Primary|Panic Disorder Severity Scale (PDSS)|The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items).|baseline, mid-TX, post-TX, follow-up visits 1-4|Seventeen subjects out of 92 (five during treatment and 12 during follow-up, 20% total) in the control group compared to six out of 88 (four during treatment and two during follow-up, 10% total) in the DCS group dropped out.|||units on a scale||Standard Deviation|Mean
2762410|NCT00790855|Secondary|Number of Participants With a Response|A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with </= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of >/= 10^9/L and a platelet count of >/=100 X 10^9/L. A partial response (PR) was defined as for CR, but with only >/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to </=5% but without recovery of peripheral counts.|1 - 24 week cycles (up to 8 weeks)||||participants|||Number
2762411|NCT00790855|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.|During course 1 (4 week cycle)||||mg/m^2|||Number
2762412|NCT00790842|Secondary|Progression-free Survival|Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.|56 months|Patients treated at the recommended phase II dose|||Months||90% Confidence Interval|Median
2762413|NCT00790842|Secondary|Pharmacokinetics of Lenalidomide in Impaired Renal Function|To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only).|56 months|As only 1 patient was enrolled from Mayo Clinic during the Phase II component of the study, samples were neither collected nor analyzed for this endpoint.||||||
2762414|NCT00790842|Secondary|Renal Function Over Time|To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.|56 months|This outcome was not analyzed because the dose increase was not implemented.||||||
2762415|NCT00790842|Secondary|Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient|The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.|56 months|All patients who started treatment|||participants|||Number
2762416|NCT00790842|Secondary|Duration of Response|Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.|56 months|Patients treated at the recommended phase II dose who experienced a response to treatment|||Months||Inter-Quartile Range|Median
2762417|NCT00790842|Secondary|Overall Survival Time|Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.|56 months|Eligible, treated patients|||months||90% Confidence Interval|Median
2762418|NCT00790842|Primary|Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]|Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components|56 months|Patients treated at the recommended phase II dose|||percentage of participants||90% Confidence Interval|Number
2762419|NCT00790842|Primary|Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy|"Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:~Grade 3 or higher neutropenia with fever ≥38.5 degrees C~Grade 4 neutropenia ≥7 days~Grade 4 or higher thrombocytopenia~Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause"|First cycle of therapy (28 days)|Patients treated during the dose finding phase of the study|||Participants|||Count of Participants
2762420|NCT00790803|Secondary|Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy|No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.|32 weeks||||participants|||Number
2762421|NCT00790803|Secondary|A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye|"The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye.~In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare.~White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body.~Blood cells: grading of blood cells in the anterior chamber is as follows:~0 - None.~1+ - faint (barely detectable).~2+ - moderate (clear iris and lens details).~3+ - moderate (hazy iris and lens details).~4+ - intense (fibrin deposits, coagulated aqueous)."|32 weeks||||participants|||Number
2762422|NCT00790803|Secondary|Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)|Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.|32 weeks||||participants|||Number
2762423|NCT00790803|Secondary|Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss|Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart.|32 weeks||||paticipants|||Number
2762424|NCT00790803|Primary|Improvement in VA ETDRS >/= 15 Letters|The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.|32 weeks|Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve.|||participants|||Number
2762425|NCT00790790|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 30% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||Time (days)|||Number
2762426|NCT00790790|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
2762427|NCT00790790|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance was the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
2762428|NCT00790790|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, followup questions rated the degree to which the issue impaired his/her ability to do work or read.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||participants|||Number
2762429|NCT00790790|Secondary|Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||participants|||Number
2762430|NCT00790790|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2762431|NCT00790790|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2762432|NCT00790790|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
2762433|NCT00790790|Secondary|Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
2762509|NCT00790335|Secondary|Major Bleeding|Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).|Within 10 days after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
2762434|NCT00790790|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762435|NCT00790790|Secondary|Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762436|NCT00790790|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicated better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762437|NCT00790790|Secondary|Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks|The Total WOMAC index (pain, stiffness, physical function subscales) was completed by the participant and had 24 questions. Each question was answered using a 5-point Likert scale (0 to 4). The Total score had a range from 0 (none) to 96 (extreme). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762438|NCT00790790|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represented better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762439|NCT00790790|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I was a scale that measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762440|NCT00790790|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S was a self-reported scale measuring severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessed worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 Weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762441|NCT00790790|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I was a self-reported scale measuring degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessed interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762442|NCT00790790|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762443|NCT00790790|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of night pain and worst pain each day, evaluated as weekly means.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.|||participants|||Number
2762444|NCT00790790|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762445|NCT00790790|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2762446|NCT00790790|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.|||units on a scale||Standard Error|Least Squares Mean
2762447|NCT00790751|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Error|Least Squares Mean
2762448|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
2762449|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
2762450|NCT00790738|Secondary|Clinical Global Impression Scores|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. At the time of rating patients are rated as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|8 weeks||||units on a scale||Standard Deviation|Mean
2762451|NCT00790738|Secondary|Clinician-Administered Rating Scale for Mania|The Clinician-Administered Rating Scale for Mania (CARS-M) contains 15 items rated from 0-5 or 0-6 on a Likert scale. It was developed to assess severity of manic symtoms. The scale ranges from 0 to 50, and the following thresholds are used: severe ≥26, moderate 16-25, mild 8-15 and normal ≤7.|8 weeks||||units on a scale||Standard Deviation|Mean
2762452|NCT00790738|Primary|Hamilton Rating Scale for Depression Scores|The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe >23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.|8 weeks||||units on a scale||Standard Deviation|Mean
2762453|NCT00790673|Secondary|Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects||16 weeks|||||||
2762454|NCT00790673|Primary|Pharmacokinetic Behavior of CF102 During Repeated Dosing||16 weeks|||||||
2762455|NCT00790673|Primary|Effect of Viral Load||16 weeks|||||||
2762456|NCT00790673|Primary|Adverse Event Profile of Repeated Dosing of CF102||16 weeks||||participants|||Number
2762457|NCT00790647|Secondary|Number of Participants Surviving at 2 Years||2 years from transplant||||Participants|||Count of Participants
2762458|NCT00790647|Secondary|Number of Participants Surviving at 1 Year||one year from transplant||||participants|||Number
2762459|NCT00790647|Secondary|Number of Participants Surviving at 100 Days From Transplant||100 Days from transplant date||||participants|||Number
2762510|NCT00790335|Secondary|Moderate-to-severe Post-thrombotic Syndrome|Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.|Between 6 and 24 months after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
2762460|NCT00790647|Primary|Number of Participants With Hematologic Response|"complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy <5% plasma cells with no clonal predominance of kappa or lambda isotype.~Partial response: any one of the following~For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells.~For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume)."|one year||||participants|||Number
2762461|NCT00790569|Secondary|Change in Cigarettes Per Day|Change in mean cigarettes per day|6-Months||||cigarettes/day||Standard Deviation|Mean
2762462|NCT00790569|Secondary|Reinforcing Effects of Smoking|Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
2762463|NCT00790569|Secondary|Use of Illicit Drugs as Measured by Urine Toxicologies||12 months|Data not collected||||||
2762464|NCT00790569|Secondary|Methadone Dose Changes||12 months|Data not collected||||||
2762465|NCT00790569|Secondary|Retention in Methadone Maintenance||12 months|Data not collected||||||
2762466|NCT00790569|Secondary|Withdrawal Symptoms|Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
2762467|NCT00790569|Secondary|Change in Smoking Urges|Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
2762468|NCT00790569|Primary|CO-confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.|12 Months||||participants|||Number
2762469|NCT00790569|Primary|Self-reported 7-day Abstinence|Number of participants with self-reported 7-day abstinence at 12-months|12 Months||||participants|||Number
2762470|NCT00790569|Primary|Rates of Smoking Cessation Continuous From First Quit Day to 6 Months|Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months|6-Months||||participants|||Number
2762471|NCT00790569|Primary|Carbon Monoxide (CO)-Confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.|6-Months||||participants|||Number
2762472|NCT00790569|Primary|Self- Reported 7-day Abstinence|Number of participants with self-reported, 7-day abstinence at 6-months|6 Months||||participants|||Number
2762473|NCT00790556|Other Pre-specified|Hepatic Glucose Production (HGP) at Baseline||Baseline|Subjects who discontinued were not used in the analysis.|||mg/kg/min||Standard Deviation|Mean
2762474|NCT00790556|Primary|Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14|Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.|Day 14 of each 14-day Treatment Period|Subjects who discontinued were not used in the analysis.|||mg/kg/min||Standard Deviation|Mean
2762475|NCT00790556|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)|"An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.~Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.~Drug-relatedness was determined by the investigator based on clinical judgement."|56 days|All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).|||participants|||Number
2762476|NCT00790452|Primary|Frequency of VTE Events|Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.|VTE evaluation with study visits (4 weeks) for up to 2 years|Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.|||participants|||Number
2762477|NCT00790400|Secondary|Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)|Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician's global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by >=25% or more.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.|||months||95% Confidence Interval|Median
2762511|NCT00790335|Secondary|Any Treatment Failure|Composite of PTS and major non-PTS treatment failure|Through 24 months|Modified full analysis set; intention to treat|||Participants|||Count of Participants
2762512|NCT00790335|Secondary|Major Non-post-thrombotic Syndrome Treatment Failure|A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.|Through 24 months|Modified full analysis set; intention to treat|||Participants|||Count of Participants
2762478|NCT00790400|Secondary|Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.|||months||95% Confidence Interval|Median
2762479|NCT00790400|Secondary|Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|"Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume > 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.|||months||95% Confidence Interval|Median
2762480|NCT00790400|Secondary|Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose|C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.|2 hours post-dose administration at Weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.|||ng/mL||Standard Deviation|Mean
2762481|NCT00790400|Secondary|Everolimus Trough Concentrations (Cmin)|Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.|Prior to dosing at weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.|||ng/mL||Standard Deviation|Mean
2762482|NCT00790400|Secondary|Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker|Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.|4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||pg/mL||Standard Deviation|Mean
2762483|NCT00790400|Secondary|Percentage of Participants With Renal Impairment|Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of <30ml/min/1.73m2.|Day 1 up to 28 days after end of treatment|Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.|||Percentage of Participants|||Number
2762484|NCT00790400|Secondary|Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)|Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician's Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2762485|NCT00790400|Secondary|Time to Angiomyolipoma Progression as Per Central Radiology Review|"Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.|||months||95% Confidence Interval|Median
2762486|NCT00790400|Primary|Angiomyolipoma Response Rate as Per Central Radiology Review|"Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
2762487|NCT00790335|Secondary|Change in Leg Circumference|Mean calf circumference measured 10 cm below the tibial tuberosity|Baseline to 30 days post-randomization|Modified full analysis set; intention to treat|||centimeters||Standard Error|Mean
2762488|NCT00790335|Secondary|Change in Leg Circumference|Mean calf circumference measured 10 cm below the tibial tuberosity|Baseline to 10 days post-randomization|Modified full analysis set; intention to treat|||centimeters||Standard Error|Mean
2762489|NCT00790335|Secondary|Change in Leg Pain Severity|Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain|Baseline to 30 days post-randomization|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762490|NCT00790335|Secondary|Change in Leg Pain Severity|Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain|Baseline to 10 days post-randomization|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762491|NCT00790335|Secondary|Change in Venous Disease-specific Quality of Life|Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.|Baseline to 24 months post-randomization|Modified full analysis set; intention to treat|||units on a scale||Standard Error|Mean
2762492|NCT00790335|Secondary|Change in General Quality of Life - Mental|Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.|Baseline to 24 months post-randomization||||units on a scale||Standard Error|Mean
2762493|NCT00790335|Secondary|Change in General Quality of Life - Physical|Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.|Baseline to 24 months post-randomization|Modified full analysis set; intention to treat|||units on a scale||Standard Error|Mean
2762494|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 24 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762495|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 18 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762496|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 12 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762497|NCT00790335|Secondary|Venous Clinical Severity Score|Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse|At 6 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762498|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 24 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762499|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 18 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762500|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 12 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762501|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 6 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
2762502|NCT00790335|Secondary|Death|All-cause mortality|Within 24 months after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
2762503|NCT00790335|Secondary|Death|All-cause mortality|Within 10 days after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
2762504|NCT00790335|Secondary|Recurrent Venous Thromboembolism|Symptomatic recurrent venous thromboembolism (DVT and/or PE)|Within 24 months after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
2762505|NCT00790335|Secondary|Recurrent Venous Thromboembolism|Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)|Within 10 days after randomization||||Participants|||Count of Participants
2762506|NCT00790335|Secondary|Any (Major + Minor) Bleeding|Clinically overt bleeding that occurred within 24 months post-randomization|Within 24 months after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
2762507|NCT00790335|Secondary|Any (Minor + Major) Bleeding|Clinically overt bleeding that occurred through 10 days post-randomization|Within 10 days after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
2762508|NCT00790335|Secondary|Major Bleeding|Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).|Within 24 months after randomization|Modified full analysis set; intention-to-treat|||Participants|||Count of Participants
2762513|NCT00790335|Primary|Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)|Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.|Between 6 and 24 months after randomization|Modified full analysis set; intention-to-treat|||Participants|||Count of Participants
2762514|NCT00790296|Primary|Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion|1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.|Baseline and 7 hours post study medication infusion||||Scores on a scale||Standard Deviation|Mean
2762515|NCT00790270|Secondary|Resumption of Work or School|number of patients resuming regular activity the day following enrollment.|next day||||participants|||Number
2762516|NCT00790270|Primary|Use of Rescue Medications|the number of patients taking additional rescue medications beyond the study meds|24 hours|number of patients using additionl anlagesics on the day following enrollment|||participants|||Number
2762517|NCT00790270|Secondary|Time to Resumption of Work||1 week|||||||
2762518|NCT00790270|Primary|Pain||Daily for 1 week|||||||
2762519|NCT00790218|Primary|Maximum Tolarated Dose|The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.|first 28 days (Cycle 1)|||||||
2762520|NCT00790218|Secondary|Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102||Baseline|||||||
2762521|NCT00790218|Secondary|Therapeutic Effect of CF102 in Hepatocellular Carcinoma||Every 2 months|||||||
2762522|NCT00790218|Primary|Repeat-dose Pharmacokinetic Behavior of CF102||1 month|||||||
2762523|NCT00790218|Primary|Dose Limiting Toxicity|Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1|From start of treatment until Day 28 of Cycle 1||||participants|||Number
2762524|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
2762525|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
2762526|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
2762527|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
2762528|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value for the outcome measure.|||g/mol Creatinine||Standard Deviation|Mean
2762529|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||g/mol Creatinine||Standard Deviation|Mean
2762530|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Intent to Treat Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value.|||Percentage of HbA1c||Standard Deviation|Mean
2762531|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Per Protocol Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||Percentage of HbA1c||Standard Deviation|Mean
2762610|NCT00789867|Primary|FEV1 Relative % Drop|FEV1 relative % drop measure|8h|A lower number of participants due to missing data|||% of drop||Standard Deviation|Mean
2762532|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Intent to Treat Population)|Change in renal function based on eGFR using the MDRD method.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.|||mL/min/1.73 m^2||Standard Deviation|Mean
2762533|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Per Protocol Population)|Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||mL/min/1.73 m^2||Standard Deviation|Mean
2762534|NCT00790205|Secondary|Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
2762535|NCT00790205|Secondary|Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
2762536|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Intent to Treat Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
2762537|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Per Protocol Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
2762538|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
2762539|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
2762540|NCT00790205|Primary|Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
2762541|NCT00790205|Primary|Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
2762542|NCT00790192|Secondary|Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).|6-Weeks||||scores on a scale||95% Confidence Interval|Least Squares Mean
2762543|NCT00790192|Primary|Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Week 6|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2762544|NCT00790088|Primary|Percentage of Patients Achieving HbA1c < 7.5%||every 3 months||||percent of patients|||Number
2762611|NCT00789867|Primary|Blood Neutrophils|Blood neutrophils measures|8h|A lower number of participants due to missing data|||1000000000/L||Standard Deviation|Mean
2762612|NCT00789867|Primary|Blood Leukocytes|Blood leukocytes measure|8h|A lower number of participants due to missing data|||x1000000000 cells/L||Standard Deviation|Mean
2762613|NCT00789867|Primary|Body Maximum Temperature||6-8h|A lower number of participants due to missing data|||celsius||Standard Deviation|Mean
2762545|NCT00790088|Secondary|Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs)|A sub-group of patients (adults) were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs) The treatment satisfaction is measured by means of the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 6 to 0. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month or 12 months compared to baseline represents a better outcome. Items 2 (perceived frequency of hyperglycaemia) and 3 (perceived frequency of hypoglycaemia) are treated individually in data analysis. Lower score at 6 months or 12 months compared to baseline represents a better outcome.|at baseline, after 3 and after 12 months||||score||Standard Deviation|Mean
2762546|NCT00790088|Secondary|Fear of Hypoglycemia Survey (HFS-II) - Worry Score|sub-group of patients (adults only) were asked to answer the fear of hypoglycemia validated questionnaires. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always. The worry subscale is the mean of 18 items which evaluate the worry score (range from 0 to 72). Lower score at 6 months or 12 months compared to baseline represents a better outcome.|at baseline, after 6 and after 12 months||||Score||Standard Deviation|Mean
2762547|NCT00790088|Secondary|Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score|"sub-group of patients (adults only in Hungary and Denmark) were asked to answer the fear of hypoglycemia validated questionnaires.~The total HFS-II questionnaire is represented by 33 items. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always.The total HFS-II score ranges from 0 to 132. Lower score at 6 months or 12 months compared to baseline represents a better outcome.~The HFS-II questionnaire is divided into 2 subscales: the behavior and the worry subscales. The behavior score is represented by 15 items and ranges from 0 to 60. Lower score at 6 months or 12 months compared to baseline represents a better outcome."|at baseline, after 6 and after 12 months||||Score||Standard Deviation|Mean
2762548|NCT00790088|Primary|Percentage of Patients Achieving HbA1c < 7%||every 3 months||||percent of patients|||Number
2762549|NCT00790088|Primary|HbA1c||every 3 months||||percent||Standard Deviation|Mean
2762550|NCT00790088|Primary|Frequency as Percentage of Sensor Usage|"To calculate the percentage of time that sensors were used during 3 months:~the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100"|every 3 months||||% of time||Standard Deviation|Mean
2762551|NCT00790062|Primary|Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors|The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.|baseline to discharge (2-3 days)||||participants|||Number
2762552|NCT00790062|Secondary|Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus|number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)|Initial hospital discharge (2-3 days or more)||||Participants|||Number
2762553|NCT00790062|Secondary|Number of Subjects With Hospital Stays Greater Than 4 Days|Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge|Initial hospital discharge (2 days or more)||||Participants|||Number
2762554|NCT00790062|Secondary|Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)|the number of individuals with a clinically estimated postpartum blood loss of 500cc or more|Initial hospital discharge (2-3 days)||||Participants|||Number
2762555|NCT00790062|Secondary|Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome|the number of individuals with each of the component treatments or individual outcomes in the primary composite.|prior to discharge||||Participants|||Number
2762556|NCT00790062|Secondary|Change in Pre- to Post-delivery Hematocrit (%)|change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)|During delivery hospitalization: Admission hematocrit - post-delivery hematocrit||||hematocrit difference (%)||Inter-Quartile Range|Median
2762557|NCT00790062|Primary|Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage|In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.|Initial hospital discharge (2-3 days)||||participants|||Number
2762558|NCT00790062|Primary|Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment|the number of subjects with any treatment of uterineatony or hemorrhage.|baseline to discharge (2 - 3 days)||||Participants|||Number
2762559|NCT00790036|Secondary|Lymphoma-specific Survival (LSS)|LSS was defined as time from randomization to death as a result of lymphoma.|From randomization to death documented as a result of lymphoma up to 7 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2762560|NCT00790036|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to date of death due to any cause. If the patient was not known to have died, survival was censored at the date of the last contact.|From date of randomization to date of death due to any cause up to around 7 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2762614|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 week of treatments||||Participants|||Number
2762561|NCT00790036|Primary|Disease-free Survival (DFS)|DFS was defined as the time from date of randomization to the date of event defined as the first documented relapse of the disease or death due to any cause. Relapse was based on investigator assessment and was assigned only if: It was documented according to Cheson guidelines by an objective radiological assessment method; It was documented by a biopsy proven lymphoma including new or recurrent bone marrow involvement; A new anticancer therapy for lymphoma started with subsequent confirmation of the relapse within 4 weeks of the start of this anticancer therapy|From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2762562|NCT00790023|Secondary|Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.|Week 0-2|Intent to Treat Population|||days||Standard Error|Least Squares Mean
2762563|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0|"Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval."|Baseline and up to 48 hours|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762564|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)|"Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.~TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval."|Baseline and up to 36 hours|Intent to Treat Population. Some participants excluded for missing data.|||Units on a scale||Standard Error|Least Squares Mean
2762565|NCT00790023|Secondary|Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0|The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In participants with a Baseline overall score >= 3.0|||units on a scale||Standard Error|Least Squares Mean
2762566|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762567|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762568|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762569|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762637|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
2762570|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762571|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762572|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762573|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762574|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762575|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762576|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762577|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762578|NCT00790023|Secondary|Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762615|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 weeks of treatment||||Participants|||Number
2762579|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762580|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762581|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762582|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
2762583|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762584|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762585|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762586|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
2762587|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population. In participants with a baseline rTOSS >= 5.0|||units on a scale||Standard Error|Least Squares Mean
2762636|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 week of treatments||||Participants|||Number
2762588|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2762589|NCT00790023|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
2762590|NCT00789997|Secondary|Number of Participants With Treatment Failure by 90 Days Assignment|In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.|Day 0 to Day 90||||participants|||Number
2762591|NCT00789997|Primary|Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.~Not all participants had Day 14 FEV1 measures collected"|Day 0 to Day 14||||percentage of change in FEV1||Standard Error|Mean
2762592|NCT00789958|Secondary|2-year Overall Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2762593|NCT00789958|Secondary|2-year Stratum-specific Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2762594|NCT00789958|Secondary|2-year Disease-free Survival in All Patients|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2762595|NCT00789958|Secondary|2-year Stratum-specific Disease-free Survival|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2762596|NCT00789958|Secondary|2-year Overall Survival for All Patients|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2762597|NCT00789958|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
2762598|NCT00789958|Primary|Stratum-specific (R0 and R1) 2-year Overall Survival|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2762599|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762600|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762747|NCT00789477|Secondary|Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF|Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|FAS|||participants|||Number
2762601|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762602|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762603|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762604|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762605|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762606|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762607|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
2762608|NCT00789867|Primary|Lung Clearance Index - LCI|Lung clearance index measure is a measure of abnormal ventilation distribution derived from the multiple breath inert gas washout technique.|8h|A lower number of participants due to missing data|||index||Standard Deviation|Mean
2762609|NCT00789867|Primary|FVC Relative % Drop|FVC relative % drop measure|6h|A lower number of participants due to missing data|||% drop||Standard Deviation|Mean
2762616|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).|6 weeks of treatment||||Participants|||Number
2762617|NCT00789854|Secondary|Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)|Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762618|NCT00789854|Secondary|Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility|Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762619|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component|Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762620|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component|Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762621|NCT00789854|Secondary|Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)|Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762622|NCT00789854|Secondary|Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4|Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)|6 weeks of treatment||||MADRS item 4 score||Standard Error|Least Squares Mean
2762623|NCT00789854|Secondary|Change in Anxiety Measured by STAI, Trait Anxiety Inventory|Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762624|NCT00789854|Secondary|Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
2762625|NCT00789854|Secondary|Change in Anxiety Measured by Visual Analog Scale (VAS)|Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762626|NCT00789854|Secondary|Change in Pain, Measured by Visual Analog Scale (VAS)|Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762627|NCT00789854|Secondary|Change in Beck Depression Inventory (BDI)|Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762628|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762629|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762630|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), All Patients|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762631|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
2762632|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
2762633|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
2762634|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment||||Participants|||Number
2762635|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment||||Participants|||Number
2762638|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
2762639|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure|Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
2762640|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure|Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
2762641|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients|Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
2762642|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
2762643|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks treatment|Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d.|||scores on a scale||Standard Error|Least Squares Mean
2762644|NCT00789828|Secondary|Percentage of Participants With Renal Impairment During Core Period|Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788*(serum creatinine (micromol/L)^-1.154)*(age^-0.203 )*(0.742, if female)*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR < 30 mL/min/1.73 m^2 and participants with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.|Day 1 up to 28 days after end of treatment (Core period)|"The analysis was performed in the SAF population. Here, Number of participants analysed signifies the participants assessed for renal function during the study for each arm, respectively."|||Percentage of participants|||Number
2762645|NCT00789828|Secondary|Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose|The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as <5 ng/mL, 5-10 ng/mL, and >10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ng/mL||Standard Deviation|Mean
2762646|NCT00789828|Secondary|Everolimus Blood Concentration (C2h) at 2 Hours Post Dose|The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as < 20 ng/mL, 20-50 ng/mL, and > 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ng/mL||Standard Deviation|Mean
2762647|NCT00789828|Secondary|Duration of Skin Lesion Response in Everolimus Treated Participants|Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by > 25% or more from baseline.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population. Here, “Number of participants analysed” signifies everolimus treated responders with best overall skin lesion response during the core and extension period, respectively.|||months||95% Confidence Interval|Median
2762648|NCT00789828|Secondary|Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score|Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician's Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but < 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - < 50% and 6 = progressive disease, indicated worse than at baseline evaluation by > 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.|End of core period (Week 48), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for skin lesion response during the study for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
2762649|NCT00789828|Secondary|Time to SEGA Worsening|Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for time to SEGA worsening during the study for each arm, respectively."|||months||95% Confidence Interval|Median
2762650|NCT00789828|Secondary|Duration of SEGA Response|Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for SEGA progression during the study for each arm, respectively."|||months||95% Confidence Interval|Median
2762651|NCT00789828|Secondary|Time to SEGA Response|Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population.|||months||95% Confidence Interval|Median
2762652|NCT00789828|Secondary|Time to SEGA Progression|Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here Number of participants analysed signifies the participants assessed for time to SEGA progression during the study for each arm, respectively."|||months||95% Confidence Interval|Median
2762653|NCT00789828|Secondary|Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period|Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was < 18 hours.|Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)|The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.|||Seizure frequency||Standard Deviation|Mean
2762654|NCT00789828|Primary|Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response|Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|End of core period (Week 48), and end of extension period (up to 4 years)|The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.|||Percentage of participants||95% Confidence Interval|Number
2762655|NCT00789815|Secondary|Patients Willing Return if Repeated Bronchoscopy is Indicated.|"Patients were asked their willingness to return for another FB if needed by means of a five-point scale (definitely not, probably not, unsure, probably would, and definitely would return). Both probably would, and definitely would return were defined as patients agreed to return."|After patients recovered orientation and before they leaved the scope room.|Patients who answered the question in the questionnaire after bronchoscopy|||participants|||Number
2762656|NCT00789815|Secondary|The Recovery Time to Ambulation|The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.|After the bronchoscopy||||Minutes||Standard Deviation|Mean
2762657|NCT00789815|Primary|The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale|The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).|After patients recovered orientation and before they leaved the scope room.|Patients received intervention completely|||units on a scale||Full Range|Median
2762658|NCT00789815|Secondary|The Recovery Time to Orientation|The time to orientation defined as the time between finishing flexible bronchoscopy to the moment when patients could open their eyes spontaneously, could recall their date of birth, and perform a finger-nose test correctly|After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation||||minutes||Standard Deviation|Mean
2762659|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by Cough|"Procedure interference by cough was when the bronchoscopist had to stop the procedure temporarily and additional xylocaine spray and/or alfentanil had to be given to stop the cough."|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth||||participants|||Number
2762660|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy|"Procedure interference by patients' movement was when the bronchoscopist had to stop the procedure temporarily and our assistant had to hold down the irritant patient"|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth||||participants|||Number
2762661|NCT00789815|Primary|The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy|The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|patients completed the whole intervention|||participants|||Number
2762662|NCT00789815|Primary|The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy|The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|Patients completed the whole intervention.|||participants|||Number
2762663|NCT00789802|Secondary|Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups|To compare continuation rates of the LNG-IUC at the end of the 12 week between the 3 study groups|12 weeks||||Participants|||Count of Participants
2762664|NCT00789802|Secondary|Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.|To compare the level of patient satisfaction with the LNG-IUC at the end of the 12 weeks between the 3 study groups.|12 weeks|There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.|||Participants|||Count of Participants
2762665|NCT00789802|Secondary|Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.|Median number of bleeding days observed in women with a LNG-IUC treated with naproxen, estradiol and placebo at 16 weeks.|16 weeks|There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.|||days||Full Range|Median
2762666|NCT00789802|Primary|Number of Bleeding and Spotting Days|The median number of bleeding and spotting days reported at 12 weeks.|12 weeks||||DAYS||Full Range|Median
2762667|NCT00789776|Secondary|Number of Participants Who Experienced Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Up to 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762668|NCT00789776|Secondary|Number of Subjects Surviving Post-transplant.|Number of subjects surviving post-transplant.|Up to 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762669|NCT00789776|Primary|Number of Participants Who Experienced Graft Failure|Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts >2 weeks and is refractory to growth factor support.|Day 100|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762670|NCT00789776|Primary|Number of Non-relapse Participant Mortalities|Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression.|Day 200|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762671|NCT00789776|Primary|Number of Participants With Grades III-IV Acute GVHD|"Number of patients who developed acute GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 100|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762672|NCT00789776|Primary|Number of Participants With Relapsed Disease|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|At 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762673|NCT00789776|Primary|Number of Participants With Dose Limiting Toxicities|Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality.|Day 35 (28 days after NK cell infusion)|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2762674|NCT00789750|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||calculation||Standard Error|Least Squares Mean
2762675|NCT00789750|Secondary|Change From Baseline in Fasting C-peptide||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||ng/mL||Standard Error|Least Squares Mean
2762676|NCT00789750|Secondary|Change From Baseline in Fasting Insulin Levels||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||µIU/mL||Standard Error|Least Squares Mean
2762677|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apo B is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
2762678|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)|Apo A-1 is measured in mg/dL|Baseline, Week 24|Intent-to-treat, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
2762679|NCT00789750|Secondary|Percent Change From Baseline in Triglycerides (TG)|TG are measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Inter-Quartile Range|Median
2762680|NCT00789750|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
2762681|NCT00789750|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
2762682|NCT00789750|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last count carried forward|||percentage of change||Standard Error|Least Squares Mean
2762683|NCT00789750|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|TC is measured in milligrams per deciliter (mg/dL)|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
2762684|NCT00789750|Secondary|Number of Participants With a Reduction in FPG of >= 30 mg/dL||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
2762685|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.5 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
2762686|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.7 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
2762687|NCT00789750|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.|Baseline, Week 24|Participants in the intent-to-treat set with values at both baseline and Week 24 with last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
2762688|NCT00789750|Secondary|Number of Participants Achieving an HbA1c Goal of <7.0%||Week 24|Intent-to-treat set, with last observation carried forward|||Participants|||Count of Participants
2762689|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 16||Baseline, Week 16|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
2762690|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 8||Baseline, Week 8|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
2762691|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 4||Baseline, Week 4|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
2762692|NCT00789750|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24||Baseline, Week 24|Intent-to-treat, last observation carried forward|||percent||Standard Error|Least Squares Mean
2762693|NCT00789737|Secondary|Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test|To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762694|NCT00789737|Secondary|Changes in Apolipoprotein B (apoB)|To assess the effects of Welchol on changes in apolipoprotein B (apoB)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762695|NCT00789737|Secondary|Changes in Apolipoprotein A-I (apoA-I)|To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762696|NCT00789737|Secondary|Changes in Triglycerides [TG]|To assess the effects of Welchol on changes in triglycerides [TG]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762697|NCT00789737|Secondary|Changes in Non-HDL-C|To assess the effects of Welchol on changes in non-HDL-C|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762698|NCT00789737|Secondary|Changes in High Density Lipoprotein Cholesterol [HDL-C]|To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||md/dL||Standard Error|Least Squares Mean
2762699|NCT00789737|Secondary|Changes in Low Density Lipoprotein Cholesterol [LDL-C]|To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762700|NCT00789737|Secondary|Changes in Total Cholesterol [TC]|To assess the effects of Welchol on changes in total cholesterol [TC]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762701|NCT00789737|Secondary|% Subjects With a Decrease in FPG >=30 mg/dL|% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
2762702|NCT00789737|Secondary|% Subjects Achieving an HbA1C Goal of <7.0|% Subjects achieving an HbA1C goal of <7.0 at 24 weeks|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
2762703|NCT00789737|Secondary|% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units|to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
2762704|NCT00789737|Secondary|Change in Fasting Plasma Glucose|to determine changes in Glycemic control after 24 weeks on therapy|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
2762705|NCT00789737|Primary|Percent Change in Hemoglobin A1c|change in HbA1c from baseline to Week 24|24 week|Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage change of hemoglobin A1c||Standard Error|Mean
2762706|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in End-diastolic Volume Indices and Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|||||||
2762707|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in E/E' Ratios and Myocardial Performance (Tei) Indices From Baseline to Follow up Exam at Transthoracic Echo-color-Doppler Cardiac Exam||10-14 weeks|||||||
2762708|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in Oxygen Uptake Kinetics From Baseline to Follow up Exam at Submaximal Cardiopulmonary Exercise Test||10-14 weeks|||||||
2762709|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Number of Adverse Effects Including a) All Events; b) All Events Requiring Unblinding of the Treatment; c) All Events Requiring Early Termination of the Intervention||10-14 weeks|||||||
2762710|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Incidence of Significant Cardiac Arrhythmias in the Acute Phase||48 hours|||||||
2762711|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in Serum BNP Levels, C-reactive Protein, and Hemoglobin A1c% From Baseline to Follow up||10-14 weeks|||||||
2762712|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in the Number of Circulating Endothelial Progenitor Cells From Baseline to Follow up Exam||10-14 weeks|||||||
2762713|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Percentage of Patients With Any of the Following : a) End-systolic or End-diastolic Volume Index Increase >10%; b) Ejection Fraction Decrease >10%; c) E/E'>15 at Follow up||10-14 weeks|||||||
2762714|NCT00789724|Primary|Difference Between the Anakinra Arm and Placebo Arm in Change in End-systolic Volume Indices From Baseline to Follow up Exam 10-14 Weeks Later at Cardiac Magnetic Resonance Imaging.||10-14 weeks||||mL/m2||Inter-Quartile Range|Median
2762715|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores|The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
2762716|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)|The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
2762717|NCT00789698|Secondary|Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.|The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.|Baseline and 6 Months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
2762826|NCT00788827|Primary|Number of Participants Who Experienced Adverse Events|Safety will be evaluated in terms of adverse events graded according to CTCTAE toxicity criteria and laboratory test results. All adverse events will also be graded for relationship to treatment and as expected and unexpected.|14 days||||participants|||Number
2762718|NCT00789698|Primary|Relapse of Psychotic Symptoms|"Time to relapse will be defined as the earliest occurrence of any of the following:~Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3~rehospitalization for worsening of psychosis~emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate."|12 Months|The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.|||participants|||Number
2762719|NCT00789685|Secondary|All Cause Mortality Rate at 6 Months|A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment|6 months following commencement of therapy|Number of patients whose survival status at 6 months was known|||percentage of patients who died|||Number
2762720|NCT00789685|Primary|All Cause Mortality at Day 28|The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment|28 days following commencement of therapy|Patients included in Safety population|||percentage of patients who died|||Number
2762721|NCT00789685|Primary|Clinically Significant Treatment Emergent Events|Treatment-emergent adverse events (TEAEs) in safety population|From first dose up until Day 28|Patients included in Safety population|||Number of patients|||Number
2762722|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa||||letters||Standard Deviation|Mean
2762723|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa||||participants|||Number
2762724|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks||||letters||Standard Deviation|Mean
2762725|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks||||participants|||Number
2762726|NCT00789672|Primary|Tolerability of Study Medication-Adverse Event Reporting|Number of adverse events reported throughout entire study.|24 weeks||||events|||Number
2762727|NCT00789672|Primary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks||||letters||Standard Deviation|Mean
2762728|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|10 weeks after stopping levodopa||||letters||Standard Deviation|Mean
2762729|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|10 weeks after stopping levodopa||||participants|||Number
2762730|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|4 weeks after enrollment||||letters||Standard Deviation|Mean
2762731|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|4 weeks after enrollment||||participants|||Number
2762732|NCT00789672|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks||||participants|||Number
2762775|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
2762733|NCT00789672|Primary|Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|9 weeks after starting levodopa||||letters||Standard Deviation|Mean
2762734|NCT00789672|Primary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|9 weeks after starting levodopa||||participants|||Number
2762735|NCT00789581|Secondary|Overall Survival|The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2762736|NCT00789581|Primary|Disease-free Survival|The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2762737|NCT00789555|Primary|Self-Rated Relief Assessment at Day 30|"Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."|Day 30|Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT). The LOCF (last observation carried forward method) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
2762738|NCT00789555|Secondary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
2762739|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
2762740|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
2762741|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
2762742|NCT00789555|Primary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data.|||Percentage of subjects|||Number
2762743|NCT00789529|Secondary|Subject Questionnaire Response|"Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.~0=Very poor 50 = Excellent"|2 weeks||||units on a scale||Standard Deviation|Mean
2762744|NCT00789529|Primary|Objective, In-vivo Soft Contact Lens Wettability Index|The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.|2 weeks|Per protocol. All participants that completed both arms were analysed.|||wettability index||Standard Deviation|Mean
2762745|NCT00789477|Secondary|Number of Focal Laser Treatments||Week 1 to week 48|For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.|||Treatments||Standard Deviation|Mean
2762746|NCT00789477|Secondary|Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF|Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52||||microns||Standard Deviation|Mean
2762748|NCT00789477|Secondary|Change in BCVA From Baseline to Week 52 - LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 52|FAS|||letters correctly read||Standard Deviation|Mean
2762749|NCT00789477|Primary|Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|"Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.~Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF)."|At week 24|The FAS was used for the primary efficacy analysis. It included patients as randomized.|||letters correctly read||Standard Deviation|Mean
2762750|NCT00789438|Primary|Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints|Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.|Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay||||SPI and delta SPI (to baseline)||Standard Error|Median
2762751|NCT00789373|Secondary|Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.|Date of randomization to date of measured PD (up to 19.3 months)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2762752|NCT00789373|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off|Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.|Baseline to date of measured progressive disease (up to 19.3 months)|All randomized participants|||percentage of participants|||Number
2762753|NCT00789373|Secondary|Percentage of Participants With Serious Adverse Events During Maintenance Phase|A summary of serious adverse events is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with all serious adverse events included.|||percentage of participants|||Number
2762754|NCT00789373|Secondary|Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase|A summary of non-serious AEs is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.|||percentage of participants|||Number
2762755|NCT00789373|Secondary|Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)||Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|All randomized participants|||percentage of participants|||Number
2762756|NCT00789373|Secondary|Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)|Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.|||units on a scale||Standard Deviation|Mean
2762757|NCT00789373|Secondary|Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score|The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.|||units on a scale||Standard Deviation|Mean
2762758|NCT00789373|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.|Date of randomization to the date of death from any cause up to 39.5 months|All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.|||months||95% Confidence Interval|Median
2762776|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
2762777|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
2762759|NCT00789373|Secondary|Independently-assessed Objective Progression-free Survival (PFS)|To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)|Randomized participants with reviewable scan--(316/359 [88%] Maintenance arm and 156/180 [87%] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).|||months||95% Confidence Interval|Median
2762760|NCT00789373|Primary|Investigator-assessed Objective Progression-free Survival (PFS)|Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)|All randomized participants|||months||95% Confidence Interval|Median
2762761|NCT00789360|Secondary|The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry|The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline|17 post-treatment time points (15 min to 32 hr)|"Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo)~LSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures"|||liters||90% Confidence Interval|Least Squares Mean
2762762|NCT00789360|Primary|The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry|The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,|17 post-treatment time points (15 min to 32 hr)|"Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo)~LSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures"|||liters||90% Confidence Interval|Least Squares Mean
2762763|NCT00789321|Secondary|Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2|Least Squares Mean Difference from Baseline|Baseline and 2 weeks|All patients treated with water displacement measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2) – two patients in the amlodipine group were excluded due to technical/procedural errors.|||Grams||Standard Deviation|Least Squares Mean
2762764|NCT00789321|Primary|Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2|Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.|Baseline and 2 weeks|All patients treated with segmental bioimpedance measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2).|||Ohms||Standard Deviation|Least Squares Mean
2762765|NCT00789256|Secondary|Number of Participants With Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.|Leukemic cells will be collected to test the presence of the study drugs using a cell viability assay in vitro and in vivo.|Pre-treatment and at complete response|No data was collected and these results were not obtained. The collaborating laboratory with the capability to perform the assay with leukemic cells was not available to analyze the samples.||||||
2762766|NCT00789256|Secondary|Determine Safety Profile of the Combination of Bortezomib and Melphalan.|The safety profile is based on the number of adverse events experienced by participants as reported in the Adverse Events results section for this protocol.|Start of treatment through 28 days post-treatment||||Participants|||Count of Participants
2762767|NCT00789256|Primary|Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.|Determine disease response to treatment using Cheson 2000 report of an international working group to standardize response criteria for myelodysplastic syndromes.|Post Cycle 1 through 28 days post-treatment||||participants|||Number
2762768|NCT00789191|Secondary|Self-measured 9-point Plasma Glucose Profile||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||mmol/L||Standard Error|Mean
2762769|NCT00789191|Secondary|Hypoglycemic Episodes: Night Time|Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2762770|NCT00789191|Secondary|Hypoglycemic Episodes: Day Time|Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2762771|NCT00789191|Secondary|Hypoglycemic Episodes|Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2762772|NCT00789191|Secondary|FPG (Fasting Plasma Glucose)||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||mmol/L||Standard Error|Mean
2762773|NCT00789191|Secondary|Change in Body Weight||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||kg||Standard Error|Mean
2762774|NCT00789191|Secondary|Change in BMI (Body Mass Index)||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||kg/m^2||Standard Error|Mean
2762779|NCT00789191|Primary|HbA1c (Glycosylated Haemoglobin A1c)||Week 26|Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
2762780|NCT00789113|Primary|Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG|To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.|1 week||||µg*h/mL||95% Confidence Interval|Geometric Mean
2762781|NCT00789074|Secondary|Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence|"Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).~* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual)."|Week 4 - 8|Participants who were abstinent at 1 week and provided data on withdrawal symptoms|||Scores on a scale||Standard Deviation|Mean
2762782|NCT00789074|Secondary|Change in Pre-quit Cigarette Consumption|Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.|Baseline - week 4|All participants that provided data at each session|||Cigarettes consumed per day||Standard Deviation|Mean
2762783|NCT00789074|Secondary|Change in Pre-quit Ratings of Cigarette Satisfaction|"Satisfaction measured on a scale of 1-5; Have you found your cigarettes more or less enjoyable than usual in the last week? 1= much more and 5 = much less"|Baseline - week 4|Participants who provided ratings of cigarette satisfaction at each visit|||units on a scale||Standard Deviation|Mean
2762784|NCT00789074|Secondary|Change in Pre-quit Cotinine Levels|Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.|Weeks 1-4 (the first 4-weeks after first medication dose)|All participants that provided data at all time points|||ng/ml||Standard Deviation|Mean
2762785|NCT00789074|Secondary|Change in Pre-quit End-expired Carbon Monoxide Reading (CO)|"Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.~CO was measured at each contact to monitor changes in smoke intake and differences between the study arms."|Baseline - week 8|Participants that provided data at all time points|||ppm||Standard Deviation|Mean
2762786|NCT00789074|Primary|Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale|The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.|24 hours and 7 days after quit date (week 4)|Were abstinent and provided data at 24 hours post quit date|||units on a scale||Standard Deviation|Mean
2762787|NCT00789035|Secondary|Trough Concentrations of Empagliflozin in Plasma|Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2762788|NCT00789035|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||kg||Standard Error|Mean
2762789|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU / mmol||Standard Error|Mean
2762790|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L x mmol/L||Standard Error|Mean
2762791|NCT00789035|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L||Standard Error|Mean
2762792|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).|12 weeks|FAS (CLOCF)|||percentage of participants|||Number
2762793|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).|12 weeks|FAS (CLOCF)|||percentage of participants|||Number
2762794|NCT00789035|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS, classical last observation carried forward (CLOCF) was used as the imputation method.|||percentage of HbA1c||Standard Error|Mean
2762795|NCT00789035|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|FAS (LOCF)|||mg/dL||Standard Error|Mean
2762796|NCT00789035|Primary|Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment|"Change of HbA1c from baseline after 12 weeks of treatment.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).|||percentage of HbA1c||Standard Error|Mean
2762797|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
2762798|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
2762799|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
2762800|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
2762801|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
2762802|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
2762803|NCT00788957|Secondary|Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.|||day*μg/ml||Standard Deviation|Mean
2762804|NCT00788957|Secondary|Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.|||μg/ml||Standard Deviation|Mean
2762805|NCT00788957|Secondary|Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab|Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set participants with at least one post-baseline immunoassay result.|||participants|||Number
2762806|NCT00788957|Secondary|Number of Participants With Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).|||participants|||Number
2762807|NCT00788957|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: Is there a reasonable possibility that the event may have been caused by the investigational product?"|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).|||participants|||Number
2762808|NCT00788957|Secondary|Overall Survival|The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||months||95% Confidence Interval|Median
2762809|NCT00788957|Secondary|On-treatment Progression-free Survival|An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.|From the date of first dose until 28 days after the last dose until the data cut-off date of 23 July 2010. Median time on treatment was 3.7, 4.9 and 5.1 months in each treatment arm respectively.|Efficacy analysis set|||months||95% Confidence Interval|Median
2762922|NCT00787761|Secondary|Disease-free Survival (DFS) at 24 Months|Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted.|24 months|23 patients were able to be analyzed for DFS at 24 months|||participants|||Number
2762810|NCT00788957|Secondary|Progression-free Survival|The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||months||95% Confidence Interval|Median
2762811|NCT00788957|Secondary|Part 2: Percentage of Participants With Disease Control|The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
2762812|NCT00788957|Secondary|Part 2: Time to Response|The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.|||months||95% Confidence Interval|Median
2762813|NCT00788957|Secondary|Part 2: Duration of Response|The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.|||months||95% Confidence Interval|Median
2762814|NCT00788957|Primary|Part 2: Percentage of Participants With an Objective Response|An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.|||percentage of participants|||Number
2762815|NCT00788957|Primary|Part 1: Number of Participants With Dose-limiting Toxicities (DLT)|A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator|7 weeks|The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.|||participants|||Number
2762816|NCT00788892|Secondary|Aplasia Rate|Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.|Day 14 (1st Induction)|Efficacy Evaluable Analysis Set|||Participants|||Count of Participants
2762817|NCT00788892|Secondary|Rate of Stem Cell Transplant|The rate of patients who underwent stem cell transplant.|Up to 1 year|Efficacy Evaluable Analysis Set|||Participants|||Count of Participants
2762818|NCT00788892|Secondary|Overall Survival Rate at 1 Year|Survival defined as the time from randomization to death.|1 year|Efficacy Evaluable Analysis Set|||participants|||Number
2762819|NCT00788892|Secondary|Event Free Survival|Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.|Up to 1 year from randomization|Efficacy Evaluable Analysis Set|||days||95% Confidence Interval|Median
2762820|NCT00788892|Secondary|Remission Duration/Time to Remission|"Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.~Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met."|Following achievement of CR over the study period|Efficacy Evaluable Analysis Set|||days||Full Range|Median
2762821|NCT00788892|Primary|Number of Participants With Complete Remission|Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.|Within 6 weeks of the last induction treatment|Efficacy Evaluable Analysis Set: All randomized subjects who received at least 1 dose of study drug. One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set.|||Participants|||Count of Participants
2762822|NCT00788827|Secondary|Serum Creatinine|Each participant had serum creatinine analysis pre and post stem cell infusion to give mean result|12 weeks|Participants who received stem cell infusion|||umol/L||Standard Deviation|Mean
2762827|NCT00788775|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).||||participants|||Number
2762828|NCT00788775|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 16.2 months (90%CI 11.7-17.7 months; no/with CNS mets 16.2m/ 11.7m).|The analysis dataset is comprised of treated patients.|||months||90% Confidence Interval|Median
2762829|NCT00788775|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|The analysis dataset is comprised of treated patients.|||months||90% Confidence Interval|Median
2762830|NCT00788775|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of treated patients.|||proportion of patients||90% Confidence Interval|Number
2762831|NCT00788710|Secondary|Average Elicited Pain Upon Sitting Over Days 1 to 3|Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 days|Full analysis set population|||Score on a scale||Standard Error|Least Squares Mean
2762832|NCT00788710|Secondary|Average Total Daily Dose of Morphine Over Days 1 to 3||3 days|Full analysis set population|||milligrams (mg)||Standard Error|Least Squares Mean
2762833|NCT00788710|Primary|Average Pain Intensity at Rest Over Days 1 to 3|Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 Days|Full analysis set population|||Score on a scale||Standard Error|Least Squares Mean
2762834|NCT00788697|Secondary|Inter-reader Agreement|"Inter-reader agreement of assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Computation for the percentage agreement within two categories: 3 out of 3 readers agree and 2 out of 3 readers agree."|24 hours to 6 months||||Percent of total number of lesions|||Number
2762835|NCT00788697|Secondary|Specific Diagnosis of Benign FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 116 ITD participants with benign lesions based on the truth standard, only 89 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.|||Benign lesions|Benign lesions to be characterized||Number
2762836|NCT00788697|Secondary|Specific Diagnosis of Malignant FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 124 ITD participants with malignant lesions based on the truth standard, only 115 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions.|||Malignant lesions|Malignant lesions to be characterized||Number
2762837|NCT00788697|Secondary|Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound|"Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100."|24 hours to 6 months|Among the 240 ITD participants, the overall number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent negative lesions by ultrasound|Negative lesions|95% Confidence Interval|Number
2762838|NCT00788697|Secondary|Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound|"Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100."|24 hours to 6 months|Among the 240 ITD participants, the overall number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent positive lesions by ultrasound|Positive lesions|95% Confidence Interval|Number
2762839|NCT00788697|Secondary|Accuracy: Percentage of True Positive and True Negative Among All Lesions|"The Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100."|24 hours to 6 months|240 participants in the ITD population|||Percent true positive and negative lesio|Total lesions|95% Confidence Interval|Number
2762840|NCT00788697|Primary|Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard|"Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100."|24 hours to 6 months|Among the 240 ITD participants, only 116 participants (lesions) were benign based on the truth standard and were included for specificity.|||Percentage of true negative lesions|Benign lesions|95% Confidence Interval|Number
2762841|NCT00788697|Primary|Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard|"Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100."|24 hours to 6 months|Among the 240 ITD participants, only 124 participants (lesions) were malignant based on the truth standard and were included for sensitivity.|||Percentage of true positive lesions|Malignant lesions|95% Confidence Interval|Number
2762842|NCT00788593|Secondary|Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."|||kg/m^2||Standard Deviation|Mean
2762843|NCT00788593|Secondary|Change From Placebo Baseline in Weight at End of Each Treatment Period|Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||kilogram (kg)||Standard Deviation|Mean
2762844|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment|Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least one dose of the study drug. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."|||percent CNA||Standard Deviation|Mean
2762845|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."|||percent CFA||Standard Deviation|Mean
2762846|NCT00788593|Primary|Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.|3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."|||percent CFA||Standard Deviation|Mean
2762847|NCT00788372|Primary|Brief Pain Inventory-Short Form (BPI-SF) Total Score|The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2762848|NCT00788372|Primary|Participants Overall Assessment|The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2762849|NCT00788372|Primary|Physician's Global Assessment Scale|The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||participants|||Number
2762850|NCT00788372|Primary|Short-Form 36-Item Health Survey (SF-36) Scores|The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2762851|NCT00788372|Primary|Number of Rescue Treatments|Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||treatments per day||Standard Deviation|Mean
2762852|NCT00788372|Primary|Number of Participants With Quality of Sleep|The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2762853|NCT00788372|Primary|Number of Participants With Total Painful Time Per Day|The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2762854|NCT00788372|Primary|Number of Participants With Pain Assessed by Categorical Scale for Pain|Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2767570|NCT00756730|Secondary|Total Cholesterol in the Two Study Groups at 24 Weeks||Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
2762855|NCT00788372|Primary|Pain Visual Analogue Scale Score|"Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Week 52 or end point (early discontinuation)|Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||mm||Standard Deviation|Mean
2762856|NCT00788372|Primary|Dependence Questionnaire (DQ)|The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.|Week 52 or end point (early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale|||Number
2762857|NCT00788372|Primary|Questionnaire of Opioid Withdrawal Symptoms|Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal.|Week 52 or endpoint (1 week after last treatment or early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2762858|NCT00788255|Primary|TTG|thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)|6 months||||mm||Standard Deviation|Mean
2762859|NCT00788255|Primary|Tmax|thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)|6 months||||minutes||Standard Deviation|Mean
2762860|NCT00788255|Primary|MRTG|thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)|6 months||||mm/min||Standard Deviation|Mean
2762861|NCT00788255|Primary|MA|thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)|6 months||||mm||Standard Deviation|Mean
2762862|NCT00788255|Primary|Alpha Angle|thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)|6 months||||degrees||Standard Deviation|Mean
2762863|NCT00788255|Primary|k Time|thromboelastographic indices - clot formation time (normal range, 1-3 min)|6 months||||minutes||Standard Deviation|Mean
2762864|NCT00788255|Primary|r Time|thromboelastographic indices - reaction time (normal range, 5-10 min)|6 months||||minutes||Standard Deviation|Mean
2762865|NCT00788151|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo|GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2762866|NCT00788151|Secondary|GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo|GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.|Pre-Injection 1 and 28 days Post-Injection 1|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2762867|NCT00788151|Secondary|Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo|Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.|Pre-Injection 1 and 28 days Post-Injection 1|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.|||Percentage of participants|||Number
2762868|NCT00788151|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo|GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2762869|NCT00788151|Secondary|Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine|Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762923|NCT00787761|Secondary|Non-relapse Mortality (NRM) at Day 180 Post-transplantation|non-relapse mortality refers to the death of a patient for causes other than relapsed disease.|Day 180|23 patients were able to be analyzed for NRM at 180 days|||participants|||Number
2767571|NCT00756730|Secondary|Difference in CD4 From Baseline to Week 24||baseline to Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||cells/mm^3||Standard Error|Mean
2762870|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine|Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762871|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine|Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.|||Percentage of participants|||Number
2762872|NCT00788151|Secondary|Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine|Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762873|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762874|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762875|NCT00788151|Secondary|Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762876|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762877|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution.|Pre-Injection 1 and 28 days Post-Injection 2 and 3|Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.|||Percentage of participants|||Number
2762878|NCT00788151|Secondary|Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762879|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762880|NCT00788151|Secondary|Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo|Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.|Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3|Analysis was performed on Full analysis set which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category.|||Percentage of participants|||Number
2763978|NCT00781274|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2762881|NCT00788151|Primary|Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.|Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3|Analysis was performed on Safety analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762882|NCT00788151|Primary|Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.|Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3|Analysis was performed on Safety analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762883|NCT00788151|Primary|Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.|Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3|Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, ‘number analyzed’ = participants with available data for specified category.|||Percentage of participants|||Number
2762884|NCT00788073|Post-Hoc|ABC-FXS Social Avoidance Subscore|After completion of the study, but during data analysis, the ABC-C assessment was independently re-validated in Fragile X Syndrome subjects. The subscales were re-factored into a Fragile-X Syndrome specific ABC-C (ABC-FX). The ABC-FX contains the same 58 questions as the original ABC-C but there are six subscales. One of the subscales is Social Avoidance, which consists of 4 items. Minimum score is 0, maximum is 12. A decreased score indicates fewer social avoidant behaviors. A post-hoc analysis was performed from the study data examining the social avoidance subscale of the ABC-FX.|4 week treatment period||||Points on a scale||Standard Error|Least Squares Mean
2762885|NCT00788073|Primary|Aberrant Behavior Checklist Irritability Subscore|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|After 4 weeks of treatment||||Points on a scale||Standard Error|Least Squares Mean
2762886|NCT00788008|Primary|Change in Neurocognitive Performance (Z-score)|"Mean change on composite scores (z-score) for memory and executive function measures.~Memory measures: Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised.~Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination.~The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range.~Higher scores (and thus positive change value) indicate an improvement of function."|3 months post operatively||||z score||Full Range|Mean
2762887|NCT00787943|Primary|Number of Inflammatory Lesions (Papules and Pustules)|Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.|4 Weeks|Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.|||Lesions|||Number
2762888|NCT00787930|Secondary|fa ROFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.|||units on a scale||Standard Deviation|Mean
2762889|NCT00787930|Secondary|fa LOFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.|||units on a scale||Standard Deviation|Mean
2762924|NCT00787761|Secondary|Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)|Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|2 years|23 patients were able to be analyzed for severe gvhd|||participants|||Number
2767572|NCT00756730|Secondary|Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24||Week 4, 12 & 24||||percentage of participants|||Number
2762890|NCT00787930|Secondary|Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).|up to 12 months|Number of subjects who who had >2 on the DWM hyperintensity assessment from the Boyko classification system.|||participants|||Number
2762891|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.|12 months|Subjects who completed at least 4-12 months of consistent follow up appointments after stabilization from an acute manic episode. Note that 3 subjects dropped out of continuation treatment.|||participants|||Number
2762892|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania|Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.|3 weeks|All subjects in an acute manic state who were treated with specified protocol.|||participants|||Number
2762893|NCT00787917|Secondary|Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||percentage of participants||Standard Error|Least Squares Mean
2762894|NCT00787917|Secondary|Change From Baseline in Average Oral Corticosteroid Use.||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||mg/day||Standard Deviation|Mean
2762895|NCT00787917|Secondary|Time to Steroid Free State.||12 months|No statistical analysis was performed due to insufficient study enrollment|||days||Standard Deviation|Mean
2762896|NCT00787917|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment||3 months, 6 months|No statistical analysis was performed due to insufficient study enrollment|||Liters||Standard Error|Least Squares Mean
2762897|NCT00787917|Secondary|Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||percentage||Standard Error|Least Squares Mean
2762898|NCT00787917|Primary|Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen||6 months of blinded treatment|No statistical analysis was performed due to insufficient study enrollment|||percentage||Standard Error|Least Squares Mean
2762899|NCT00787904|Secondary|Bone Mineral Density|Please note that the bone density measurements were done AFTER THE PRIMARY endpoints because bone mineral density changes take longer to see differences|2 years|||||||
2762900|NCT00787904|Primary|Percent Change in Thymus Size Measured by CT Scan||2 years||||percent change||Standard Deviation|Mean
2762901|NCT00787904|Primary|Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells|(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)|2 years||||percentage of CD3 positive cells||Standard Deviation|Mean
2762902|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
2762903|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
2762904|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
2762925|NCT00787761|Secondary|Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease|number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|Day 100|23 patients were able to be analyzed for severe gvhd|||participants|||Number
2762905|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
2762906|NCT00787891|Primary|The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|36 weeks|Intention to Treat (ITT) analysis set|||Percentage of patients||95% Confidence Interval|Number
2762907|NCT00787891|Primary|The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|12 weeks|Intention to Treat (ITT) analysis set|||Percentage of participants||95% Confidence Interval|Number
2762908|NCT00787852|Secondary|Complete and Partial Response by CT Scan or MRI||within 30 days of last treatment|||||||
2762909|NCT00787852|Primary|Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0|6 patients came off study for toxicity|within 28 days after the last radiation treatment||||participants|||Number
2762910|NCT00787839|Secondary|Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes|Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off.|3 years||||Dollars|||Number
2762911|NCT00787839|Primary|Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)|"Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).~ROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.~It is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity."|3 years||||area under ROC curve||95% Confidence Interval|Number
2762912|NCT00787800|Secondary|Atrial Fibrillation (AF) Burden|AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.|Implantation through 1 year|Intent to treat analysis population.|||Percentage of atrial arrhythmias per min||Standard Deviation|Mean
2762913|NCT00787800|Secondary|Number of Subjects With Newly Detected Atrial Tachyarrhythmias||Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.|||Participants|||Number
2762914|NCT00787800|Secondary|Total Cost of ICD Implantation Procedure||Baseline|Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.|||US Dollars||Standard Deviation|Mean
2762915|NCT00787800|Secondary|Number of Appropriate Shocks by ICD|Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.|Baseline to 12 Months|Intent to Treat population analyzed.|||Shocks|||Number
2762916|NCT00787800|Secondary|Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes|Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.|Baseline to 12 Months|Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).|||Episodes|||Number
2762917|NCT00787800|Primary|Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)|An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).|Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.|||Participants|||Number
2762918|NCT00787787|Secondary|Median Overall Survival|Survival estimated by Kaplan-Meier method|From start of treatment until death from any cause, assessed up to 3 years||||days||Full Range|Median
2762919|NCT00787787|Secondary|Best Response by RECIST Criteria|Incidence rate of best clinical response (complete response [CR], partial response [PR], stable disease [SD], or progressive disease[PD]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years|Only 4 patients in this study had assessments of response by RECIST criteria.|||Participants|||Count of Participants
2762920|NCT00787787|Primary|Median Progression-free Survival|Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment to time of progression or death from any cause, assessed up to 3 years||||days||Full Range|Median
2762921|NCT00787761|Secondary|Overall Survival (OS) at 24 Months|Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease.|24 months|23 patients were able to be analyzed for OS at 24 months|||participants|||Number
2762926|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|180 days|20 of the patients treated on study had chimerism drawn on day 180.|||participants|||Number
2762927|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|20 of the patients treated on this study had Day 90 chimerism drawn.|||participants|||Number
2762928|NCT00787761|Primary|Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|only 15 of the patients treated on study had Day 30 chimerism results.|||participants|||Number
2762929|NCT00787722|Secondary|NMO-IgG Aquaporin- 4 Autoantibody Titer|NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant.|Pretransplant and 5 year Post Transplant|The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant.|||Participants|||Count of Participants
2762930|NCT00787722|Secondary|Disability Score: Expanded Disability Status Scale (EDSS)|"Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart.~The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability."|pretransplant 6 month, 5 year|The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant.|||score on a scale||Full Range|Mean
2762931|NCT00787722|Secondary|Number of Patients Who Require No Device Assistance for Ambulation|No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant|6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant|The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant.|||Participants|||Count of Participants
2762932|NCT00787722|Secondary|Post HSCT Immune -Modulating Medication and Relapse|Number of immune - modulating medication and relapse evaluated 5 year - after the transplant|Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant|The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant.|||Participants|||Count of Participants
2762933|NCT00787722|Secondary|Quality of Life (QOL) Short Form - 36 (SF-36)|SF- 36 is a self-administered quality of life exam. The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best.|pre-transplant 12mo and 5 years|The reason that the number analyzed differs in one or more rows is because 1 patient did not complete the form and was excluded. Another patient was not 5 years out from transplant so there is no 5 year data on the patient.|||score on a scale||Standard Deviation|Median
2762934|NCT00787722|Primary|Survival|survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant|6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant|The reason that the number analyzed in one or more rows differs from the overall number analyzed is because one patient with coexistent SLE died of complications from active lupus 10 months after the transplant and another patient was only 3 years out from transplant.|||Participants|||Count of Participants
2762935|NCT00787644|Primary|PC20|"Airway reactivity will be measured with methacholine challenge testing following ATS guidelines.~This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)"|12 weeks||||mg/ml||Standard Deviation|Median
2762936|NCT00787618|Primary|Cmax of Proellex||48 hours|Study prematurely terminated||||||
2762937|NCT00787605|Secondary|Evaluate the Safety and Tolerability|Percentage of patients with Adverse Event and percentage of patients with edema|after 8 weeks of treatment|safety|||Percentage of participants|||Number
2762938|NCT00787605|Secondary|Biomarker Measurements|Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)|Baseline and Week 8|Full analysis set, intent-to-treat|||ratio||95% Confidence Interval|Geometric Mean
2762939|NCT00787605|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg.|after 8 weeks of treatment|Full analysis set, intent-to-treat|||Percentage of Participants|||Number
2762940|NCT00787605|Secondary|Percentage of Responders|Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline|Week 8|Full analysis set, intent-to-treat|||Percentage of Participants|||Number
2762941|NCT00787605|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline and Week 8|Full analysis set, intent-to-treat|||mmHg||Standard Error|Least Squares Mean
2762942|NCT00787605|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set, intent-to-treat|||mmHg||Standard Error|Least Squares Mean
2762943|NCT00787566|Secondary|Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS|VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied|24 hours|||||||
2762956|NCT00787527|Primary|Phase II MTD of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days||||mg/three times daily|||Number
2762957|NCT00787527|Primary|Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat|MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.|21 Days||||participants|||Number
2762958|NCT00787527|Primary|Phase I Maximum Tolerated Dose (MTD) of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days||||mg/day|||Number
2762959|NCT00787332|Primary|New Thrombosis, Amputation, Death, Major and Minor Bleeding||30 days|All patients receiving drug|||participants|||Number
2762960|NCT00787319|Other Pre-specified|Physician's Assessment of Tolerability|Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||participants|||Number
2762961|NCT00787319|Other Pre-specified|Mean Number of Doses of Study Medication Received||Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||doses||Standard Deviation|Mean
2762962|NCT00787319|Other Pre-specified|Duration of Treatment|Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||weeks||Standard Deviation|Mean
2762963|NCT00787319|Other Pre-specified|Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||participants|||Number
2762964|NCT00787319|Other Pre-specified|Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring|Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||participants|||Number
2762965|NCT00787319|Secondary|Physician's Assessment of Efficacy|Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Week 104 or End of study (EOS)|FAS included all enrolled participants who received study medication.|||participants|||Number
2762966|NCT00787319|Secondary|Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.|Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||participants|||Number
2762967|NCT00787319|Secondary|Change From Baseline in Visual Acuity (VA) at Each Visit|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||logMAR||Standard Deviation|Mean
2762968|NCT00787319|Primary|Change From Baseline in Visual Acuity (VA) at Final Visit|Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Final Visit (Week 104 or early termination [ET])|Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.|||logMAR||Standard Deviation|Mean
2762969|NCT00787267|Secondary|Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.||||||
2762970|NCT00787267|Secondary|Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.||||||
2762971|NCT00787267|Secondary|Grade 3-5 Toxicity Associated With Dasatinib Treatment|Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment.|Duration of dasatinib treatment plus 30 days|All subjects who received at least one dose of dasatinib were included in the analysis.|||participants|||Number
2762972|NCT00787267|Secondary|Overall Survival|Overall survival (OS) is the duration from date of consent to date of death from any cause.|Progression and survival every 6 months|All subjects who received at least one dose of dasatinib were included in the analysis.|||months||95% Confidence Interval|Median
2762973|NCT00787267|Primary|Tumor Response|"Tumor response rate was defined by RECIST criteria:~CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started"|2 years|Unable to determine the response for 9 subjects.|||participants|||Number
2762974|NCT00787254|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|Per Incidence (up to 24 months).||||participants|||Number
2762975|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762976|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762977|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762978|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762979|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762980|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)|The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762981|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2768905|NCT00746733|Secondary|Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population|||mmHg||Standard Deviation|Mean
2762982|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762983|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762984|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762985|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762986|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762987|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762988|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762989|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762990|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762991|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762992|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762993|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762994|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762995|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762996|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762997|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762998|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2762999|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763000|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763001|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763002|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763003|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763004|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763005|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763006|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763007|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763008|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763009|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763010|NCT00787254|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|On occurrence (up to month 24).|On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.|||participants|||Number
2763011|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763012|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763013|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763014|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763015|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763016|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763017|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763018|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763019|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763020|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2763021|NCT00787254|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|24 Months|Participants not taking investigational drug were not included.|||participants|||Number
2763022|NCT00787241|Secondary|Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia|Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.|1 week to time of neuraxial analgesia||||Hours||Full Range|Median
2763023|NCT00787241|Secondary|Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia|The positive predictive value of the platelet count closest to neuraxial analgesia with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the closest platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the closest available platelet count multiplied by 100.|0 to 72 hours following delivery||||percentage of positive platelet counts|||Number
2763024|NCT00787241|Primary|Positive Predictive Value of Earliest Available Platelet Count|The positive predictive value of the earliest available platelet count with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the first platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the earliest available platelet count multiplied by 100.|0 to 72 hours following delivery||||percentage of positive platelet counts|||Number
2763025|NCT00787202|Secondary|Plasma Concentration of CP-690,550|Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.|0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8|Analysis population included all participants who had at least 1 plasma concentration. N=evaluable participants for this measure.|||ng/mL||Standard Deviation|Mean
2763026|NCT00787202|Secondary|Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||milligram per kilogram (mg/kg)||Standard Deviation|Mean
2763027|NCT00787202|Secondary|Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||milligram per liter (mg/L)||Standard Deviation|Mean
2763028|NCT00787202|Secondary|Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2763029|NCT00787202|Secondary|Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12|Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Baseline-observation-carried-forward (BOCF) was used for participants who withdrew as TF. Missing data due to reasons other than treatment failure were excluded. N=evaluable participants for the measure.|||units on a scale||Standard Deviation|Mean
2763030|NCT00787202|Secondary|Percentage of Participants With Endoscopic Remission|Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
2763031|NCT00787202|Secondary|Percentage of Participants With Endoscopic Response|Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
2763032|NCT00787202|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
2763033|NCT00787202|Primary|Percentage of Participants With Clinical Response|Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.|||percentage of participants|||Number
2763034|NCT00787189|Primary|Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.|Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.|baseline and one week||||participants|||Number
2763035|NCT00787150|Other Pre-specified|Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
2763036|NCT00787150|Other Pre-specified|Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||pmol/L||Standard Deviation|Mean
2763037|NCT00787150|Other Pre-specified|Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
2763038|NCT00787150|Other Pre-specified|Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban|Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||Second||Standard Deviation|Mean
2763039|NCT00787150|Other Pre-specified|Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||International normalized ratio||Standard Deviation|Mean
2763096|NCT00786565|Primary|Mesoptic Contrast Sensitivity|The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 Months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
2763040|NCT00787150|Other Pre-specified|Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||second||Standard Deviation|Mean
2763041|NCT00787150|Other Pre-specified|Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|0, 2, 4 hours postdose at Week 1 and Week 8|The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
2763042|NCT00787150|Secondary|Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period|"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day."|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
2763043|NCT00787150|Secondary|Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period|"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day."|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
2763044|NCT00787150|Secondary|Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period|"The definition of the Intended Treatment Period was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day."|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
2763045|NCT00787150|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period|Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
2763046|NCT00787150|Secondary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period|Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
2763047|NCT00787150|Secondary|Number of Participants With Total Bleeding Events During the Treatment Period|Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
2763048|NCT00787150|Primary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
2763049|NCT00787137|Primary|The Number of Episodes of Change From Screening in Laboratory Assessments|Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.|Three months||||Number of episodes of change|||Number
2763050|NCT00787137|Primary|The Number of Episodes of Change in Electrocardiogram|Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.|Three months||||Number of episodes of change|||Number
2763051|NCT00787137|Primary|The Number of Episodes of Change in Vital Signs|Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.|Three months||||Number of episodes of change|||Number
2763052|NCT00787137|Primary|The Percentage of Participants With Adverse Events||Three months|All patients dosed were evaluated|||Percentage of Participants|||Number
2763053|NCT00787137|Primary|The Number of Reported Adverse Events|This was an exploratory study and all safety endpoints were considered.|Three months|All adverse events reported for all patients dosed were evaluated|||Number of adverse events|||Number
2763054|NCT00787124|Primary|SNOHgB Levels|levels were never run by the laboratory|beginning and end of study|||||||
2763055|NCT00787124|Secondary|Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.|data not appropriately collected for the analysis due to machine malfunctions.|prior to, during, after transfusion|||||||
2763056|NCT00787020|Secondary|Cerebrospinal Fluid (CSF) Output Per Day||14 Days||||Milliliter||95% Confidence Interval|Mean
2763057|NCT00787020|Secondary|External Ventricular Drain (EVD) Complications|External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.|14 Days||||Participants|||Number
2763058|NCT00787020|Primary|Cerebral Artery Vasospasm|Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.|14 days||||Participants|||Number
2763059|NCT00786994|Primary|Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.|"Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.~The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success."|18 weeks||||participants|||Number
2763060|NCT00786916|Primary|Maximal Pain/Discomfort|"FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever."|during initial 3 minute propofol infusion|All enrolled subjects were randomized into groups A, B or C by hospital pharmacists utilizing a standard prerandomization methodology.|||units on a scale||Standard Deviation|Mean
2763061|NCT00786864|Secondary|Hamstring Flexibility|Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).|3 months post-intervention|Intention to treat analysis|||degrees||Standard Deviation|Mean
2763062|NCT00786864|Primary|Low Back Pain Intensity|The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.|3 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
2763063|NCT00786864|Secondary|Neural Mobility|Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.|3 months post-intervention|Intention to treat analysis|||degrees||Standard Deviation|Mean
2763064|NCT00786864|Primary|Low Back Pain Prevalence|All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.|3 months post-intervention|Intention to treat analysis|||participants|||Number
2763065|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett's Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett's Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||milli seconds||Standard Deviation|Mean
2763066|NCT00786838|Secondary|Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose||Baseline (predose on Day 1) to 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.|||beats per minute||Standard Deviation|Mean
2763067|NCT00786838|Secondary|Number of Participants With QRS Interval Greater Than 120 Milli Seconds|QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763097|NCT00786565|Secondary|High Contrast Visual Acuity||12 months|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
2763098|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||3 months|Patients without missing values for BHCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
2763068|NCT00786838|Secondary|Number of Participants With PR Interval Greater Than 200 Milli Seconds|PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763069|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 500 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763070|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 480 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763071|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 450 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763072|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763073|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
2763074|NCT00786838|Secondary|Time Taken to Acheive Maximum Plasma Concentration (Tmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||hours||Standard Deviation|Mean
2763075|NCT00786838|Secondary|Maximum Plasma Concentration of Trabectedin (Cmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||nanogram per milliliter||Standard Deviation|Mean
2763076|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||milli seconds||Standard Deviation|Mean
2763077|NCT00786825|Primary|Brain Glycogen Turnover Rate||1 month||||mg/kg/min||Standard Deviation|Mean
2763078|NCT00786799|Secondary|Change in Serum TNFα (Cytokine) Level||Baseline and 1 year||||pg/ml||Standard Deviation|Mean
2763079|NCT00786799|Secondary|Change in Percentage of Serum Omega-3 Fatty Acids|Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)|Baseline and 1 year||||Percent change of levels of fatty acid||Standard Deviation|Mean
2763080|NCT00786799|Primary|Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)|"Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from no problem to major problem). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement."|Baseline and 1 year||||scores on a scale||Standard Deviation|Mean
2763081|NCT00786682|Secondary|Overall Survival||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.||||||
2763082|NCT00786682|Secondary|Time to Disease Progression||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.||||||
2763083|NCT00786682|Primary|Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.|"We will use a two-stage optimal Simon's design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The expected sample size of the trial is 23.5 with the null response rate of 50%."|4 years|Upon reviewing response data for the first 8 patients, we noted that there were no responses thus far. As per the two-stage optimal Simon's design, we would need 8 responses in 15 patients to proceed to stage 2 but we would not have crossed that threshold. The study was stopped due to lack of improved efficacy compared to historical controls.||||||
2763084|NCT00786643|Secondary|Time to Progression|Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months||||Months||95% Confidence Interval|Median
2763085|NCT00786643|Secondary|Early Response Rate (RR) (Stratum 1 Only)|Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.|After 4 cycles of treatment (approximately 56 days)|Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome.|||Participants|||Number
2763086|NCT00786643|Primary|Best Response (BR)|BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.|After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)|The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome.|||Participants|||Number
2763087|NCT00786565|Secondary|Posterior Capsule Opacification|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|12 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.|||EPCO Score||Standard Deviation|Mean
2763088|NCT00786565|Secondary|Contrast Sensitivity Mesoptic|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
2763089|NCT00786565|Secondary|Contrast Sensitivity Mesoptic 1.5 Cpd|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
2763090|NCT00786565|Secondary|Contrast Sensitivity Photopic|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
2763091|NCT00786565|Secondary|Contrast Sensitivity Photopic 1.5cpd|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
2763092|NCT00786565|Secondary|Low Contrast Visual Acuity|Uncorrected Low contrast visual acuity - LogMar visual acuity value|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||LogMar||Standard Deviation|Mean
2763093|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||24 Months|Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control.|||LogMar||Standard Deviation|Mean
2763094|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||24 Months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.|||LogMar||Standard Deviation|Mean
2763095|NCT00786565|Primary|Posterior Capsule Opacification Score|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|24 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.|||EPCO Score||Standard Deviation|Mean
2763100|NCT00786565|Secondary|High Contrast Visual Acuity|High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.|1 month|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
2763101|NCT00786565|Primary|Photopic Contrast Sensitivity|The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
2763102|NCT00786565|Primary|Low Contrast Uncorrected Visual Acuity Following Cataract Surgery|Low contrast uncorrected visual acuity 3 months post cataract surgery|3 months|Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy|||LogMAR||Standard Deviation|Mean
2763103|NCT00786565|Primary|Low Contrast Best Corrected Visual Acuity Following Cataract Surgery|Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.|3 months|Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy.|||LogMAR||Standard Deviation|Mean
2763104|NCT00786487|Primary|Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion|Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)|at 6 hours after starting lipid/glycerol infusion||||M value||Standard Deviation|Mean
2763105|NCT00786474|Secondary|Number of Participants With Minor Bleeding|Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data|||participants|||Number
2763106|NCT00786474|Secondary|Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism||from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||participants|||Number
2763107|NCT00786474|Primary|Major Bleeding|Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||participants|||Number
2763108|NCT00786474|Primary|Number of Arterial Thromboembolic Events|The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||Arterial thromboembolic events|||Number
2763109|NCT00786422|Secondary|Percentage of Participants With Other Vascular Events|All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death.|Up to 3 months treatment and during subsequent 1 day|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
2763110|NCT00786422|Secondary|Percentage of Participants With Treatment Emergent Deaths - 7 Days Window|Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure.|Up to 3 months treatment and during subsequent 7 days|All participants|||Percentage of participants|||Number
2763111|NCT00786422|Secondary|Percentage of Participants With All Deaths|All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure.|Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month|All participants|||Percentage of participants|||Number
2763112|NCT00786422|Secondary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug).|Up to 3 months treatment and during subsequent 30-day observational period for an individual participant|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
2763113|NCT00786422|Primary|Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)|All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|Up to 3 months treatment and during subsequent 2 days|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
2763175|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration|Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||Ratio|||Number
2763114|NCT00786422|Primary|Pharmacokinetics - Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||µg/L||90% Confidence Interval|Median
2763115|NCT00786422|Primary|Pharmacokinetics - Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||µg/L||90% Confidence Interval|Median
2763116|NCT00786422|Primary|Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban|AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||(µg*h)/L||90% Confidence Interval|Median
2763117|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Slope|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope.|Up to 3 months treatment|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||s*(µg/L)^-1|||Number
2763118|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Baseline Value|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline.|The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||Seconds||Standard Deviation|Mean
2763119|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)||7 months|17 patients were Lupus anticoagulant negative at entry.|||Participants|||Count of Participants
2763120|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)||7 months|13 patients were Smith negative at entry.|||Participants|||Count of Participants
2763121|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP||7 months|8 patients were negative for anti-RNP at entry|||Participants|||Count of Participants
2763122|NCT00786409|Primary|SLEDAI Change Score|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.|7 months||||units on a scale||95% Confidence Interval|Mean
2763123|NCT00786409|Primary|Anti-HPV 18 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
2763124|NCT00786409|Primary|Anti-HPV 18 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
2763125|NCT00786409|Primary|Anti-HPV 16 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
2763126|NCT00786409|Primary|Anti-HPV 16 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
2763127|NCT00786409|Primary|Anti-HPV 11 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
2763128|NCT00786409|Primary|Anti-HPV 11 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
2763129|NCT00786409|Primary|Anti-HPV 6 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
2763130|NCT00786409|Primary|Anti-HPV 6 Seroconversion|Percent Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
2763131|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8|Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.|Week 4 and Week 8||||BMI Kg/m2||Standard Error|Mean
2763132|NCT00786188|Secondary|Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8|"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.~The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question."|Week 4 and Week 8||||Percentage of true responders|||Number
2763133|NCT00786188|Secondary|Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.|Week 8||||units on a scale||Standard Error|Mean
2763134|NCT00786188|Secondary|Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8|The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 4 and Week 8||||Percentage of participants|||Number
2763135|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4|"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question."|Week 4||||percentage of responders|||Number
2763136|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4|"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 335.~The percentage of participants who had a change from baseline in the total score at Week 4 is reported below."|Week 4||||percentage of participants|||Number
2763137|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8|"Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).~The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.~The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8."|Week 8||||participants|||Number
2763138|NCT00786188|Secondary|Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8|"A scale was not used for this measurement.~Composite scores of hot flashes were calculated by using the following formula:~CS = (2 • Fm + 3 • Fs)~Where:~CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score."|Week 4 and Week 8||||Composite score||Standard Error|Mean
2763139|NCT00786188|Secondary|Change From Baseline in Climacteric Symptoms at Week 8|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 8||||units on a scale||Standard Error|Mean
2763140|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8|"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.~SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)~Where:~SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score."|Week 4 and Week 8||||Severity score||Standard Error|Mean
2763141|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8|"The number of hot flashes reported in the result table are:~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week."|Week 4 and Week 8|MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)|||Hot flashes||Standard Error|Mean
2763155|NCT00785928|Secondary|Change From Baseline in Serum Immunoglobulin up to 24 Weeks|Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||gram per liter (g/L)||Standard Deviation|Mean
2763142|NCT00786032|Primary|BCI System Usage by the ALS Patient|"This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate - The proportion of correct selections made during the daily calibration period of copy spelling. Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users."|Up to 18 months||||number of selection per minute||Standard Deviation|Mean
2763143|NCT00786032|Primary|BCI System Usage by the ALS Patient|"This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate - The proportion of correct selections made during the daily calibration period of copy spelling. Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged."|Up to 18 months||||percentage of days||Standard Deviation|Mean
2763144|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.|Up to 18 months||||percentage of BCI time||Standard Deviation|Median
2763145|NCT00786032|Secondary|Facility Support Speed of Solution|This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.|Up to 18 months||||hours||Standard Deviation|Mean
2763146|NCT00786032|Secondary|Time of BCI Impact on the Significant Other and Systems Operator|The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).|Up to 18 months||||minutes||Standard Deviation|Mean
2763147|NCT00786032|Secondary|BCI Usage by and Impact on the ALS Patient|At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.|Up to 18 months||||units on a scale||Standard Deviation|Mean
2763148|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.|Up to 18 months||||days||Standard Deviation|Mean
2763149|NCT00786019|Primary|Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training|Evaluate potential changes in cardiac function by echocardiography following 2 interventions: Three months of exercise training and acute vitamin C administration. Ejection fraction (EF) is a measurement of the percentage of blood leaving your heart each time it contracts, typically measure by echocardiography. Numbers listed are absolute EF values.|7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training||||percentage of blood leaving the heart||Standard Deviation|Mean
2763150|NCT00786019|Primary|Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training|Characterize the purported cardiac dysfunction during exercise in people with type 2 diabetes (T2D). In a normal patient when measuring circumferential strain, results are negative with downward tracing (as strain is a relative change in length). Circumferential strain is a measurement of ventricular circumference within the heart vessels, measured via echocardiography.|7 months; Measures are made at rest and after exercise for baseline, at rest and after infusion for Vitamin C administration, and at rest and after exercise following the exercise training||||percentage of change in length||Standard Deviation|Mean
2763151|NCT00785980|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on 20 subjects out of the 21 subjects who completed the study. One value was determined to be unreliable and was not used.|||ng-hr/mL||Standard Deviation|Mean
2763152|NCT00785980|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.||||ng-hr/mL||Standard Deviation|Mean
2763153|NCT00785980|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on twenty-one (21) subjects who successfully completed the study. Three (#3) subjects were dropped by the sponsor due to protocol violation.|||ng/mL||Standard Deviation|Mean
2763154|NCT00785928|Secondary|Number of Participants Experiencing An Adverse Event|Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.|Baseline up to 24 weeks|All randomized participants who received any amount of blinded study drug.|||Participants|||Count of Participants
2763156|NCT00785928|Secondary|Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. Total B cell counts (CD20+CD3-) are represented by the number of cells per microliter (cells/µL). The reference range is 43 - 602 cells/µL.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||cells per microliter (cells/µL)||Standard Deviation|Mean
2763157|NCT00785928|Secondary|Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks|T1/2,tau is defined as the apparent steady state elimination within the dosing interval. T1/2,tau was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.|24 weeks|The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.|||days|||Number
2763158|NCT00785928|Secondary|Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks|C-trough is defined as the concentration of LY2127399 at the end of the dosing interval after the subcutaneous (sc) injection dosing once every 4 weeks. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.|24 weeks|The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.|||micrograms per milliliter (µg/mL)|||Number
2763159|NCT00785928|Secondary|Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains. MCS and PCS scores = 0 to 100 (higher scores indicate better health status).|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
2763160|NCT00785928|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks|The FACIT Fatigue Scale is a brief participant-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
2763161|NCT00785928|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks|Percent change = [(postbaseline CRP - baseline CRP)/baseline CRP]*100.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percent change||Standard Deviation|Mean
2763162|NCT00785928|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks|Participant's assessment of physical function. Disability section of questionnaire scores participant's self-perception on degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do) when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities. Scores for each of the functional areas were averaged to calculate the functional disability index. The HAQ-DI total score, which is the average of the nonmissing functional scores, ranges from 0 (no disability) to 3 (severe disability).|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
2763163|NCT00785928|Secondary|Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks|Physician's assessment of disease activity using a visual analog scale (VAS) that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
2763164|NCT00785928|Secondary|Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks|Participant's assessment of disease activity using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
2763165|NCT00785928|Secondary|Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks|Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
2763166|NCT00785928|Secondary|Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks|The EULAR28 categorizes clinical response based upon improvement since baseline in the Disease Activity Score (DAS) modified to include the 28 joint count (DAS28) and post-baseline DAS28 level. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (participant global visual analog scale [VAS]). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).|Up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
2763167|NCT00785928|Secondary|Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks|DAS (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of his or her disease activity (participant global visual analog scale [pt global VAS]). The DAS28 is calculated by using the following formula: DAS28-CRP = 0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014*pt global VAS + 0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
2763168|NCT00785928|Secondary|Change From Baseline in Swollen Joint Count up to 24 Weeks|The number of swollen joints was determined by examination of 28 joints which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||swollen joints||Standard Deviation|Mean
2763169|NCT00785928|Secondary|Change From Baseline in the Tender Joint Count up to 24 Weeks|Number of tender and painful joints was determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. Participant was asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||tender joints||Standard Deviation|Mean
2763170|NCT00785928|Secondary|Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks|ACR20 Responder Index is composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|Up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF)/non-responder imputation (NRI). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
2763171|NCT00785928|Primary|Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with >50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|Up to week 24|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). Two participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
2763172|NCT00785798|Primary|Number of Subjects With Stable Disease (SD)||2 years||||participants|||Number
2763173|NCT00785798|Primary|Number of Subjects With Progressive Disease (PR)||2 years||||participants|||Number
2763174|NCT00785785|Primary|Time to Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to month 37|Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.|||months||Full Range|Median
2763208|NCT00785538|Secondary|Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)|Analysis was not performed due to lack of available assay.|Before the last infusion of each treatment cycle|Zero participants were analyzed due to lack of available assay.||||||
2763176|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model|Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||Ratio|||Number
2763177|NCT00785772|Primary|Observed Plasma Gabapentin Concentration|Plasma gabapentin concentrations were measured on Day 8 and Day 15|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||µg/mL||Full Range|Mean
2763178|NCT00785707|Secondary|Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.|24 months||||units on a scale||Full Range|Mean
2763179|NCT00785707|Primary|To Validate the LittleEARS Auditory Questionnaire|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.|24 months||||units on a scale||Full Range|Mean
2763180|NCT00785629|Primary|Serum Phosphorus|mean serum phosphorus from months 3-9|months 3-9|ITT analysis was ALL active patients combined versus all placebo patients combined|||mg/dL||Standard Deviation|Mean
2763181|NCT00785577|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
2763182|NCT00785577|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||time (days)|||Number
2763183|NCT00785577|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.|||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
2763184|NCT00785577|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.|||participants|||Number
2763185|NCT00785577|Secondary|Number of Participants With Suicidal Behaviors and Ideations|"The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a yes answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation."|Baseline through week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||participants|||Number
2763186|NCT00785577|Secondary|Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score|The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763187|NCT00785577|Secondary|Percentage of Participants With Reported Hypoglycemic Events|"Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the Investigations system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||percentage of participants|||Number
2763188|NCT00785577|Secondary|Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||participants|||Number
2769848|NCT00737568|Secondary|Development of Drug-resistant Mutations (DRMs)|The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.|Baseline to Week 240|Full Analysis Set|||participants|||Number
2763189|NCT00785577|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2763190|NCT00785577|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2763191|NCT00785577|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
2763192|NCT00785577|Secondary|Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
2763193|NCT00785577|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763194|NCT00785577|Secondary|Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763195|NCT00785577|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763196|NCT00785577|Secondary|Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks|NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5‑point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3‑point bothersome/importance scale (1=none to 3=very).|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763197|NCT00785577|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763209|NCT00785538|Secondary|Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1|All participants who received study drug and had PK data available to calculate Vss. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2763198|NCT00785577|Secondary|Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks|SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763199|NCT00785577|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.|||units on a scale||Standard Error|Least Squares Mean
2763200|NCT00785577|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763201|NCT00785577|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763202|NCT00785577|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763203|NCT00785577|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.|||participants|||Number
2763204|NCT00785577|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763205|NCT00785577|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
2763206|NCT00785577|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.|||units on a scale||Standard Error|Least Squares Mean
2763207|NCT00785538|Secondary|Number of Participants With Best Overall Response|"Stable Disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD). PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants with a global deterioration of their health status requiring discontinuation of treatment without objective evidence of disease progression at that time were to be reported as symptomatic deterioration"|Enrollment to study completion up to 215 weeks|All enrolled participants.|||Participants|||Count of Participants
2763210|NCT00785538|Secondary|Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses|CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.|Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1|All participants who received study drug and had PK data available to calculate CLss.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2763211|NCT00785538|Secondary|Half-Life (t1/2) of IMC-A12 Following Multiple Doses|Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1|All participants who received study drug and had PK data available to calculate t1/2. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.|||days||Geometric Coefficient of Variation|Geometric Mean
2763212|NCT00785538|Secondary|Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses||Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1|All participants who received study drug and had PK data available to calculate AUCτ.|||micrograms*hour/milliliter (µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2763213|NCT00785538|Secondary|Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses||Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1|All participants who received study drug and had PK data available to calculate Cmin.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2763214|NCT00785538|Secondary|Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses||Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1|All participants who received study drug and had PK data available to calculate Cmax.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2763215|NCT00785538|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12.|6 weeks|All participants who received at least 1 dose of study drug and completed Cycle 1 and 2-week observation or discontinued treatment for an IMC-A12-related toxicity.|||mg/kg|||Number
2763216|NCT00785538|Primary|Number of Participants With Adverse Events (AEs) or Deaths|Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Enrollment to study completion up to 215 weeks|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2763217|NCT00785512|Secondary|Trough Sitting Systolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)||||mm HG||Standard Deviation|Mean
2763218|NCT00785512|Primary|Trough Sitting Diastolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)||||mm HG||Standard Deviation|Mean
2763219|NCT00785486|Primary|The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam|Qualaquin (quinine) - AUC tau alone at steady state (day 9) and in the presence of coadministered midazolam 2 mg (day 10) over the dosing interval (0 - 8 hours), as calculated by the linear trapezoidal method.|Days 9 and 10 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours|per protocol|||ng•h/mL||Standard Deviation|Mean
2763220|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine).|AUC inf for Midazolam and hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with steady state Qualaquin(quinine)- the sum of AUC0-t plus the ratio of the last measured plasma concentration to the elimination rate constant to determine whether a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|per protocol|||ng·h/mL||Standard Deviation|Mean
2763221|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State.|Area under the concentration time curve(AUC 0-t) calculated by the linear trapezoidal method from time 0 to 24 hours, for Midazolam and 1-hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with Qualaquin -(quinine) at steady state to determine if a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|by protocol|||ng•h/mL||Standard Deviation|Mean
2763222|NCT00785486|Primary|Maximum Serum Concentration (Cmax)|Maximum serum concentration(Cmax)|Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)|per protocol|||ng/ml||Standard Deviation|Mean
2763223|NCT00785356|Primary|The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.||3 months|||||||
2763224|NCT00785291|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization to death or last follow-up (up to 5 years)||||months||95% Confidence Interval|Median
2763225|NCT00785291|Secondary|12 Month Progression Free Survival|Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|12 months|Participants who never began protocol treatment were excluded.|||percentage of participants||95% Confidence Interval|Number
2763283|NCT00784758|Secondary|Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score|The SNOT-22 is a disease-specific quality of life score for rhinosinusitis. SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||units on a scale||Standard Error|Mean
2763226|NCT00785291|Secondary|Time to Treatment Failure|Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)|Participants who never began protocol treatment were excluded.|||months||95% Confidence Interval|Median
2763227|NCT00785291|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).|Up to 5 years||||percentage of participants|||Number
2763228|NCT00785291|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)|Participants who never began protocol treatment were excluded.|||months||95% Confidence Interval|Median
2763229|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug-hr/mL||Standard Deviation|Mean
2763230|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug-hr/mL||Standard Deviation|Mean
2763231|NCT00785213|Primary|Maximum Plasma Concentration (Cmax) of Rosiglitazone|The maximum or peak concentration that rosiglitazone reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug/mL||Standard Deviation|Mean
2763232|NCT00785044|Primary|Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status|The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months|Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.|||Ratio||Standard Deviation|Mean
2763233|NCT00784979|Secondary|Monitor Patient Survival||5 years|||||||
2763234|NCT00784979|Secondary|Monitor Graft Survival||5 years|||||||
2763235|NCT00784979|Primary|The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor|The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.|four weeks||||percent of subjects becoming compatible|||Number
2763236|NCT00784927|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.||||months||95% Confidence Interval|Median
2763237|NCT00784927|Secondary|Progression-free Survival Time|"Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.~Progressive disease is defined as having one of the following:~The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Up to 1 year from registration.||||months||95% Confidence Interval|Median
2763238|NCT00784927|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.||||months||95% Confidence Interval|Median
2770130|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 78||Baseline and week 78|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2763239|NCT00784927|Secondary|Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia).|"The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.||||percentage of participants||95% Confidence Interval|Number
2763240|NCT00784927|Primary|Assessment of Tumor Response|"The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.||||percentage of participants||95% Confidence Interval|Number
2763241|NCT00784875|Secondary|Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||milliseconds||Standard Error|Least Squares Mean
2763242|NCT00784875|Secondary|Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||beats per minute||Standard Error|Least Squares Mean
2763243|NCT00784875|Secondary|Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint|Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).|2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.|||participants|||Number
2763244|NCT00784875|Secondary|Change From Baseline in Weight at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||kilogram||Standard Error|Least Squares Mean
2763245|NCT00784875|Secondary|Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||beats per minute||Standard Error|Least Squares Mean
2763246|NCT00784875|Secondary|Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||mmHg||Standard Error|Least Squares Mean
2763247|NCT00784875|Secondary|Number of Participants With Serious Adverse Events (SAEs)|SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.|||participants|||Number
2763248|NCT00784875|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.|||participants|||Number
2763249|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group|Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline through 8 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.|||participants||Standard Error|Least Squares Mean
2763250|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline, 2 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.|||minutes||Standard Error|Least Squares Mean
2763251|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type|Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline through 8 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.|||participants|||Number
2763252|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline, 2 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.|||minutes||Standard Error|Least Squares Mean
2763253|NCT00784875|Secondary|Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
2763254|NCT00784875|Secondary|Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
2763255|NCT00784875|Secondary|Treatment Satisfaction as Measured by the Participant Drug Preference Question|After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.|Baseline (Period A) and 2 weeks (Period B)|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
2763256|NCT00784875|Secondary|Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint|The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
2763257|NCT00784875|Secondary|Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
2763258|NCT00784875|Secondary|Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint|The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
2763259|NCT00784875|Secondary|Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint|DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
2763315|NCT00784719|Primary|Percentage of Participants With Ocular Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.|Baseline up to Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2763260|NCT00784875|Secondary|Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint|Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
2763261|NCT00784875|Secondary|Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint|Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||ratio||Standard Error|Least Squares Mean
2763262|NCT00784875|Secondary|Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint|Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
2763263|NCT00784875|Secondary|Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint|Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||number of awakenings||Standard Error|Least Squares Mean
2763264|NCT00784875|Secondary|Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint|Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
2763265|NCT00784875|Primary|Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
2763266|NCT00784849|Secondary|Superficial Skin Necrosis|the number of participants who developed post-operative skin necrosis within 2 weeks of surgery|2 weeks postoperatively||||participants|||Number
2763267|NCT00784849|Secondary|Safety (Allergic Reaction to Blue Dye)|number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension|intraoperatively up to 6 hours||||participants|||Number
2763268|NCT00784849|Primary|The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)||intraoperatively; up to 6 hours||||participants|||Number
2763269|NCT00784836|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Planned for up to 18 months plus 30 days; actual study duration was 111 days.||||participants|||Number
2763270|NCT00784836|Primary|Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)|The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.|assessed every 3 months up to 18 months|The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.||||||
2763341|NCT00784563|Other Pre-specified|Change in Geriatric Depression Scale Score|=Score after 6 months training - score at baseline. The Geriatric Depression Scale (GDS)-short form is a 15 item yes/no questionnaire. The range is 0-15 and scores >5 suggest depression. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
2763271|NCT00784810|Secondary|Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.|"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)."|Between visit 8 and 9|The number of participants for analysis is less due to subject withdrawals or lack of data.|||Number of rescue medication intakes||Standard Deviation|Mean
2763272|NCT00784810|Primary|Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)|The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)|Average daily pain over last 24 hours (at Week 12)|To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.|||Units on a BS-11 scale at Week 12||Standard Deviation|Mean
2763273|NCT00784784|Primary|Number of Laboratory Confirmed Influenza Infections|Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)|6 months|intention to treat|||infections|||Number
2763274|NCT00784784|Secondary|Number of Subjects Adhering to Long-term Zanamivir Prophylaxis|Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).|5 months|ITT|||participants||95% Confidence Interval|Number
2763275|NCT00784758|Secondary|Change in Transition Dyspnea Index - Magnitude of Effort|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)|Baseline to final assessment visit (15 weeks)|All subjects who completed Visit 4 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2763276|NCT00784758|Secondary|Change in Transition Dyspnea Index - Magnitude of Task|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)|Baseline to final assessment visit (15 weeks)|All subjects who completed Visit 4 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2763277|NCT00784758|Secondary|Change in Transition Dyspnea Index - Functional Impairment|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)|Baseline to final assessment visit (15 weeks)|All subjects who completed Visit 4 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2763278|NCT00784758|Secondary|Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2763279|NCT00784758|Secondary|Change in Transition Dyspnea Index - Magnitude of Task at Visit 3|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2763280|NCT00784758|Secondary|Change in Transition Dyspnea Index (TDI) - Functional Impairment|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2763281|NCT00784758|Secondary|Daytime Symptom Score|Daytime symptoms due to asthma were assessed via the electronic diary (AM2+ Asthma Monitor) each evening for 7 days prior to the study visit at Week 15. Daily scores were derived from five questions relating to 1) frequency of asthma symptoms, 2) impact of asthma symptoms, 3) activity, 4) impact of asthma on activity, and 5) breathlessness. Each question was scored from 0 (best) to 6 (worst), with the average of 5 questions providing a daily score ranging from 0 (best) to 6 (worst). Each participant's symptom score was calculated as the average of 7 daily scores. Thus, the range of possible scores is from 0 (best) to 6 (worst).|7 days prior to final assessment visit at week 15|All subjects whose diaries were functioning and who completed diary assessments and completed Visit 3 were included in the analysis.|||score on a scale||Standard Deviation|Mean
2763282|NCT00784758|Secondary|Change in SNOT-22 Nasal Sub-score|Sino-nasal outcome test-22 nasal sub-score. The nasal subscore consists of 8 questions, each on a scale of 0 (no problems) to 5 (as bad as it can be). Higher scores indicate worse symptoms of rhinosinusitis.|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||SNOT22 score||Standard Error|Mean
2763284|NCT00784758|Secondary|Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)|The mini AQLQ is a questionnaire specifically designed to assess health status in patients with asthma. The mini-AQLQ consists of 15 questions covering symptoms and activities. Each question is scaled from 1 (poorly controlled asthma) to 7(maximally controlled asthma) where 7 reflects a higher quality of life. Total score is the sum of 15 items and may range from 15-105. An increase in the AQLQ score indicates a better quality of life.|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||units on a scale||Standard Error|Mean
2763285|NCT00784758|Secondary|Change in Asthma Control Test Score|The Asthma Control Test is a 5-item questionnaire using 1-5 point Likert scales; maximum score 25 = complete control of asthma; minimum score 5 = poor control of asthma.|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||ACT score||Standard Error|Mean
2763286|NCT00784758|Secondary|Change in Spirometry FEF25-75%|A measure of forced expiratory flow between 25% and 75% of FVC (FEF25-75%)|Baseline to completion of treatment at 9 weeks|All subjects who completed treatment (weeks 5-9) were included in the analysis.|||L/s||Standard Error|Mean
2763287|NCT00784758|Secondary|Change in Spirometry - FEV1/FVC||Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||Ratio||Standard Error|Mean
2763288|NCT00784758|Secondary|Change in Spirometry - Forced Vital Capacity (FVC)||Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||L||Standard Error|Mean
2763289|NCT00784758|Secondary|Change in Spirometry - FEV1||Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||L||Standard Error|Mean
2763290|NCT00784758|Secondary|Change in Asthma Control Questionnaire 6 Score|Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms.|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 were included in the analysis.|||ACQ6 score||Standard Error|Mean
2763291|NCT00784758|Secondary|Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days|Percent of rescue-free days during a two week period after completing treatment phase|2 weeks after completion of treatment (weeks 10 -11)|All subjects whose short-acting bronchodilator counters were functioning and who completed Visit 3 were included in the analysis|||Percent of days||95% Confidence Interval|Mean
2763292|NCT00784758|Secondary|Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use|Daily short-acting bronchodilator use during the 2 weeks, modeled as a zero-modified negative binomial (usually 2 puffs/day)|2 weeks after completion of treatment (weeks 9-11)|All subjects whose short-acting bronchodilator counters were functioning and who completed Visit 3 were included in the analysis.|||Puffs/day||Standard Deviation|Mean
2763293|NCT00784758|Primary|Change in Asthma Control Questionnaire (ACQ) 7 Score|Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms and a question completed by the staff for categorization of the patient/subjects forced expiratory volume in the first second (FEV1) from spirometry.|Baseline to completion of treatment at 9 weeks|All subjects who completed Visit 3 (5 weeks of treatment) were included in the analysis.|||ACQ7 score||Standard Error|Mean
2763294|NCT00784719|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
2763295|NCT00784719|Secondary|Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8|mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.||||||
2763296|NCT00784719|Secondary|Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).|Baseline, Week 1, 2, 4, 6, 8|Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.||||||
2763297|NCT00784719|Secondary|Percentage of Participants With >= 10 Units Decrease in Total OSDI Score|OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
2767275|NCT00759096|Primary|Near Uncorrected Visual Acuity(UCVA|Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.|6 months after surgery of 2nd eye||||logMAR||Standard Deviation|Mean
2763298|NCT00784719|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here ‘N’ (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2763299|NCT00784719|Secondary|Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8|Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||drops/day||Standard Deviation|Mean
2763300|NCT00784719|Secondary|Percentage of Participants With >= 5 Units Decrease in Total OCI Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
2763301|NCT00784719|Secondary|Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2763302|NCT00784719|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8|TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||seconds||Standard Deviation|Mean
2763303|NCT00784719|Secondary|Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8|Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2763304|NCT00784719|Secondary|Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining|Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
2763305|NCT00784719|Secondary|Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8|Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2763356|NCT00784524|Secondary|Immune Response|Immune responses will be assessed by DTH responses to LMI, IFN-gamma production by CD8+ T cells using the ELISPOT assay, and CD8+ T cell binding to HLA-A2 multimers complexed with breast cancer-derived peptides (multimer analysis).|48 hours|ELISpot assays were not run because the HLA-multimer assay did not show any strong responses. As such, only DTH responses to LMI were assessed.|||Participants|||Count of Participants
2763306|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
2763307|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6|ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
2763308|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||mm||Standard Deviation|Mean
2763309|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||mm||Standard Deviation|Mean
2763310|NCT00784719|Secondary|Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
2763311|NCT00784719|Secondary|Time to Achieve 100 Percent (%) Clearance of Corneal Staining|Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
2763312|NCT00784719|Secondary|Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
2763313|NCT00784719|Primary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.|||percentage of participants|||Number
2763314|NCT00784719|Primary|Percentage of Participants With Ocular Tolerability Assessment|Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).|Baseline up to Week 8|ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2763316|NCT00784719|Primary|Percentage of Participants With Systemic Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.|Baseline up to Week 8|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2763317|NCT00784654|Other Pre-specified|C-SSRS During the Randomized Withdrawal Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)|Randomized Safety Population|||participants|||Number
2763318|NCT00784654|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|From open-label baseline to Week-26|Open-label Safety Population|||participants|||Number
2763319|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Randomized Withdrawal Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Randomized withdrawal baseline|Randomized FAS|||percentage of participants|||Number
2763320|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period|||Scores on a scale||Standard Deviation|Mean
2763321|NCT00784654|Secondary|Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period.|||Scores on a scale||Standard Deviation|Mean
2763322|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
2763323|NCT00784654|Secondary|Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||scores on a scale||Standard Deviation|Mean
2763324|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||T-scores||Standard Error|Least Squares Mean
2763325|NCT00784654|Secondary|Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||T-scores||Standard Deviation|Mean
2763326|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Deviation|Mean
2763327|NCT00784654|Secondary|Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||scores on a scale||Standard Deviation|Mean
2763413|NCT00784147|Secondary|Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS|The mean change in CD4+ T-cell count from the Baseline measurement at Week 24/End of Study was summarized at each scheduled time point by treatment group.|Week 24 / End of Study||||cell/mL||Standard Deviation|Mean
2763328|NCT00784654|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period|"Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.~Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories."|At Week 26|Open-label FAS|||percentage of improved participants|||Number
2763329|NCT00784654|Secondary|Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At endpoint of the randomized withdrawal period (Up to 6 weeks)|Randomized FAS|||percentage of participants|||Number
2763330|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Open-label baseline|Open-label FAS|||percentage of participants|||Number
2763331|NCT00784654|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At Week 26|Open-label FAS|||percentage of participants|||Number
2763332|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
2763333|NCT00784654|Secondary|Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Open-label baseline and Endpoint (Week-26)|Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period.|||Scores on a scale||Standard Deviation|Mean
2763334|NCT00784654|Primary|Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period|"Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period.~Subjects without an endpoint value were classed as treatment failures."|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period.|||percentage of participants|||Number
2763335|NCT00784563|Other Pre-specified|Change in LEDD (Levodopa Equivalent Daily Dose)|=amount after 6 months training - amount at baseline Total antiparkinsonian treatment daily dose expressed in levodopa equivalents per Tomlinson et al (PMID:21069833). Higher scores are worse.|6 months||||mg/day||Standard Deviation|Mean
2763336|NCT00784563|Secondary|Change in Percent Increase Score (PIS) on Eriksen's Flanker Task|performance on the Eriksen's flanker task (see PMID: 24991037). Participants were asked to identify the orientation of a central arrow cue ('<' or '>'), which was flanked on both sides by two arrow cues that either pointed in the same direction (congruent: <<<<<) or a different direction (incongruent: >><>>). Using reaction times (RT) during congruent and incongruent trials, the PIS was calculated as =((RT_incongruent - RT_congruent) / RT_congruent) * 100. Higher PIS is worse.|6 months||||Percentage of Increase score||Standard Deviation|Mean
2763337|NCT00784563|Secondary|Change in the MOCA Score|=Score after 6 months training - baseline score. MOCA=Montreal Cognitive Training Assessment Scores range 0-30, higher is better.|6 months||||units on a scale||Standard Deviation|Mean
2763338|NCT00784563|Secondary|Change in the Total UPDRS Score|"=Score after 6 months training - baseline score The total UPDRS score is calculated by adding Section I, Section II, and Section III scores (below). Higher scores are worse. The score ranges 0-176.~Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108."|6 months||||units on a scale||Standard Deviation|Mean
2763339|NCT00784563|Secondary|Change in the UPDRS Section III Score|=Score after 6 months training - baseline score Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
2763340|NCT00784563|Other Pre-specified|Change in Parkinson's Disease Quality of Life Scale (PDQUALIF) Score|= PDQUALIF score after 6 months training - baseline score The PDQUALIF is a 32 item questionnaire resulting in 7 factors. . Subjects rate themselves between 1 (most favorable) and 5 (least favorable) on a Likert scale. Factor scores are standardized to100 and lower scores are better. The outcome measure is the average of these 7 factor scores.|6 months||||units on a scale||Standard Deviation|Mean
2765339|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
2763342|NCT00784563|Other Pre-specified|Change in Fatigue Severity Scale Score|=Score after 6 months of training - baseline score. The Fatigue Severity Scale (FSS) is a self-administered unidimensional generic 9-item fatigue rating scale. These are rated on a seven-grade Likert scale of which only the respective ends are defined (''completely disagree''=1 to ''completely agree''=7). The total FSS score represents the mean score of each of the nine items, yielding a score range between 1 and 7, higher scores indicating a higher level of fatigue.|6 months||||units on a scale||Standard Deviation|Mean
2763343|NCT00784563|Secondary|Change in UPDRS Section II Score|=Score after 6 months training - baseline score Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
2763344|NCT00784563|Secondary|Change in the UPDRS Section I Score|=Score after 6 months training - baseline score Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
2763345|NCT00784563|Secondary|Change in 7 Meter Walk Time|Time complete the 7 m Walk test after 6 months aerobic training - Time complete the 7 m Walk test at baseline|6 months|See PMID: 24991037|||seconds||Standard Deviation|Mean
2763346|NCT00784563|Primary|Change in Aerobic Fitness|"VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting).~Please see publication PMID: 24991037 for details."|6 months|Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for all analyses.|||ml/min/kg||Standard Deviation|Mean
2763347|NCT00784550|Secondary|Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint|The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.|Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)|ITT Population|||points on a scale||Standard Error|Mean
2763348|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)|ITT Population|||ml||Standard Error|Mean
2763349|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).|Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)|ITT Population|||ml||Standard Error|Mean
2763350|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.|Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)|ITT Population|||ml||Standard Error|Mean
2763351|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)|ITT Population|||ml||Standard Error|Mean
2763352|NCT00784550|Primary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||milliliters (ml)||Standard Error|Mean
2763353|NCT00784524|Secondary|Overall Survival|Number of participants alive at 2 years|2 years||||Participants|||Count of Participants
2763354|NCT00784524|Secondary|Overall Survival|Number of participants alive at one year|1 Year||||Participants|||Count of Participants
2763355|NCT00784524|Secondary|Progression-free Survival|"Progression free survival will be measured in months from time of response to time of disease progression as defined by RECIST (appendix II), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."|Up to 1 year|One patient's disease had not progressed by the time the study-specified follow-up period had ended and was not included in the analysis..|||months||Inter-Quartile Range|Median
2763357|NCT00784524|Primary|Disease Response|Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 2 years||||Participants|||Count of Participants
2763358|NCT00784459|Primary|Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept||3 months||||percentage of cells||Standard Deviation|Mean
2763359|NCT00784459|Primary|Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge|collected prior to randomization to abatacept or placebo|baseline||||percentage of cells||Standard Deviation|Mean
2763360|NCT00784368|Secondary|Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)|Level of Improvement in Endoscopy was assessed as disappeared, decreased, improved, no change, worsened and could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
2763361|NCT00784368|Secondary|Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment|Level of Improvement in the Endoscopy or Image diagnosis was assessed as disappeared (if the abnormal findings were normalized), decreased (if level of pathogenic fungus was decreased in culture), improved (if significant improvement was observed in the abnormal findings), no change (if no significant improvement was observed in the abnormal findings), worsened (if the abnormal findings were worsened) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
2763362|NCT00784368|Secondary|Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), worsened (if the test values increased) and could not be assessed (if it was difficult to make above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
2763363|NCT00784368|Secondary|Number of Participants With Serological Effect Against Fungi by Centralized Assessment|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), no change (if there was no change in the test values) , worsened (if the test values increased) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
2763364|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)|Mycological efficacy was assessed as disappeared, decreased, no change, increased, could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
2763365|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Centralized Assessment|Mycological efficacy was assessed as disappeared (if results for pathogenic fungus became negative, or if it was not possible to obtain the appropriate specimens), decreased (if level of pathogenic fungus was decreased in culture), no change (if there was no quantitative change in pathogenic fungus), increased (if there was a quantitative increase in pathogenic fungus, if results for pathogenic fungus became positive after start of dosing or if new pathogenic fungus was identified) , could not be assessed (if it was difficult to make the above assessment due to lack of detection in tests).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
2763366|NCT00784368|Secondary|Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)|E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||percentage of participants||95% Confidence Interval|Number
2763367|NCT00784368|Secondary|Percentage of Participants With Overall Response by Centralized Assessment|Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
2763368|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
2763369|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Centralized Assessment|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
2763370|NCT00784368|Primary|Time Above Minimum Inhibitory Concentration (T>MIC)|The T>MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||percent time||Standard Deviation|Mean
2763371|NCT00784368|Primary|Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)|The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||hour||Standard Deviation|Mean
2763372|NCT00784368|Primary|Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)|The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||ratio||Standard Deviation|Mean
2763373|NCT00784368|Primary|Minimum Inhibitory Concentration (MIC)|The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||mcg per ml||Standard Deviation|Mean
2763374|NCT00784368|Primary|Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])|The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg*hour(hr) per ml.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||mcg*hr per ml||Standard Deviation|Mean
2763375|NCT00784368|Primary|Maximum Plasma Itraconazole Concentration (Cmax)|The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||mcg/ml||Standard Deviation|Mean
2763376|NCT00784303|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib|Safety assessments consisted of monitoring and recording all AEs (serious and non-serious) and SAEs; concomitant medications, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, New York Heart Association (NYHA) assessments, electrocardiograms (ECGs), echocardiograms; and performance of physical examinations.|For each participant, from the first dose till 30 days after the last dose of study treatment (up to approximately 10 years 4 months)|Safety population included all participants who received at least 1 dose of study drug and had at least 1 posttreatment safety assessment.|||Participants|||Number
2763377|NCT00784303|Secondary|Overall Survival (OS)|OS was defined as the time from the date of treatment start until death from any cause. The duration of OS was calculated as 'end date minus date of first drug plus 1', based on assessments by IIR. Participants without a reported death or those lost to follow-up were censored at their last known alive date at the database cutoff. OS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl.|From date of treatment start until date of death from any cause, assessed up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months|ITT population|||Months||95% Confidence Interval|Median
2763378|NCT00784303|Secondary|Progression Free Survival (PFS) Assessed as Per IIR|PFS was defined as the time from the date of treatment start until progressive disease or death from any cause in the absence of progressive disease. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions as assessed by IIR using RECIST 1.0. The duration of PFS was calculated as end date minus date of first drug plus 1, based on assessments by IIR. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl.|From date of treatment start until date of progressive disease or death from any cause, assessed up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months|ITT population|||Months||95% Confidence Interval|Median
2763379|NCT00784303|Secondary|Time to Response (TTR) Assessed as Per IIR|"TTR was defined as time from start of treatment to the time when a participant first achieves a response of PR/CR based on assessments by IIR. TTR was only calculated for participants with confirmed PR or CR."|From date of treatment start until date of first CR or PR, assessed up to data cutoff date 11 April 2011|The Efficacy Evaluable Population included all participants who received at least one dose of the study treatment, had a baseline and at least one posttreatment tumor response evaluation. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||Months||95% Confidence Interval|Median
2763380|NCT00784303|Secondary|Clinical Benefit Rate (CBR) Assessed as Per IIR|CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks, based on assessments by IIR. CBR = CR+PR+SD greater than or equal to 23 weeks|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months|ITT population. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||Percentage of participants||95% Confidence Interval|Number
2763381|NCT00784303|Secondary|Disease Control Rate (DCR) Assessed as Per IIR|DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks, based on assessments by IIR. DCR = CR+PR+SD greater than or equal to 7 weeks|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months|ITT population. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||Percentage of participants||95% Confidence Interval|Number
2763382|NCT00784303|Secondary|Duration of Response (DoR) Assessed as Per Independent Imaging Reviewers (IIR)|DoR was based on IIR was the time from date of the first CR or PR until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, for the participants who had BOR of CR or PR. Participants without progressive disease or death were censored at the date of last adequate tumor assessment. Duration of response = End Date - Date of first CR or PR + 1|From date of the first CR or PR until the date of first documentation of disease progression or date of death, assessed up to data cutoff date 11 April 2011|ITT population. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||Months||95% Confidence Interval|Median
2763414|NCT00784147|Secondary|Mean Change From Baseline in Viral Load (log10) at Week 24/EOS|The mean change in HIV-1 RNA (log10) from the Baseline measurement was analyzed at Week 24/End of Study using a generalized linear model at each scheduled study visit.|Week 24 / End of Study||||log10 copies/mL||Standard Deviation|Mean
2770131|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 66||Baseline and week 66|Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2763383|NCT00784303|Secondary|Change From Baseline in Concentrations of Activated Caspase 3/7 (Casp 3/7)|Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Cycle 1 Day 8, Cycle 2 Days 1, 8, and 15, Cycles 3 to 9, 11, 13 (Day 1), Final Visit, and analyzed for Casp 3/7 concentration. Changes in Casp 3/7 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. The concentrations of Casp 3/7 were BQL for most participants at most time points. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics.|Cycle 1 (Day 8), Cycle 2 (Days 1, 8, & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points.|||U/W||Standard Deviation|Mean
2763384|NCT00784303|Secondary|Change From Baseline in Concentrations of M-30 Neo-Antigen|Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 &15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for M-30 concentration. Changes in M-30 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as BQL, zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics.|Cycle 1 (Day 8), Cycle 2 (Days 1, 8 & 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11 & 13 (Day 1) and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points.|||U/L||Standard Deviation|Mean
2763385|NCT00784303|Secondary|Change From Baseline in Concentrations of Cytochrome C (CytoC)|Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Cycle 1 Day 8, Cycle 2 Days 1,8 &15, Cycles 3 to 9,11,13 Day 1, Final Visit, and analyzed for CytoC concentration. Changes in CytoC concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For results reported as below quantifiable level (BQL), zero was used for calculating summary statistics. If more than 50% of the results at a visit were BQL, then only 'n', 'minimum' and 'maximum' were calculated for summary statistics.|Cycle 1 (Day 8), Cycle 2 (Days 1, 8 and 15), Cycles 3, 4, 5, 6, 7, 8, 9, 11, & 13 (Day 1), and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 2 Day 1, for MTC cohort at Cycle 2 Day 15, Day 1 of Cycle 11 and 13 because no participant was evaluable at these time points.|||pg/mL||Standard Deviation|Mean
2763386|NCT00784303|Secondary|Percent Change From Baseline in Concentrations of Carcinoembryonic Antigen (CEA) (MTC Only)|Blood samples were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for CEA concentration. Percent changes in CEA concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.|Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included.|||percent change||Standard Deviation|Mean
2763387|NCT00784303|Secondary|Percent Change From Baseline in Concentrations of Calcitonin (MTC Only)|Blood samples to obtain serum were collected at Cycle 1 Day 1(Baseline), Day 1 of Cycles 2 to 20, Final Visit, and were analyzed for calcitonin concentration. Percent changes in calcitonin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.|Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included.|||percent change||Standard Deviation|Mean
2763388|NCT00784303|Secondary|Percent Change From Baseline in Concentrations of Thyroglobulin (DTC Only)|Blood samples to obtain serum were collected at Cycle 1 Day 1 (Baseline), Day 1 of Cycles 2 to 19, Final Visit, and were analyzed for thyroglobulin concentration. Percent changes in thyroglobulin concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.|Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 19, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included.|||percent change||Standard Deviation|Mean
2763389|NCT00784303|Secondary|Change From Baseline in Free Thyroid Stimulating Hormone (TSH)|Blood samples to measure free TSH were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free TSH concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included. For any free TSH result that was reported as <0.008 mIU/L, 0.004 mIU/L was used for calculating summary statistics.|Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. For each change from baseline assessment time point, only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 1 Day 15 and Cycle 20 Day 1 because no participant was evaluable at these time points.|||mIU/L||Standard Deviation|Mean
2763415|NCT00784147|Other Pre-specified|Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 0.5 log10 reduction from the Baseline measurement in HIV-1 RNA at Week 24 of the study.|Week 24||||percentage of patients|||Number
2763390|NCT00784303|Secondary|Change From Baseline in Free Thyroxine (T4)|Blood samples to measure free T4 were collected at Screening (Baseline), Cycle 1 Day 15 (MTC cohort), Day 1 of Cycles 2 to 20, and Final Visit. Changes in free T4 concentration values from baseline to specific time points were calculated. Only participants with both baseline and relevant visit values were included.|Day 1 or within 72 hours prior to Day 1 of Cycles 2 to 20, and Final Visit, up to data cutoff date 11 April 2011 (Cycle length= 28 days)|All participants who received at least 1 dose of study drug. Only participants with both baseline and relevant visit/time point values were included. Data not reported for DTC cohort at Cycle 1 Day 15 and Cycle 20 Day 1 because no participant was evaluable at these time points.|||pmol/L||Standard Deviation|Mean
2763391|NCT00784303|Primary|Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC)|Up to 9 samples per participant were obtained at specific time points. Plasma concentrations of lenvatinib were analyzed using standard analysis methods. Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors for PK model development and covariate analysis. Individual exposure (steady state AUC) to lenvatinib in MTC and DTC subjects in this study was derived based on the individual predicted steady state AUC from the final PK model. Only data for participants taking 24 mg lenvatinib daily were reported (participants taking 20 mg lenvatinib daily were not included in this data set).|Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days)|PK population included all participants who received the 24 mg daily lenvatinib dose and had concentration values above the limit of quantification and non-missing PK sampling/dose time.|||ng·h/mL||Full Range|Median
2763392|NCT00784303|Primary|Objective Response Rate (ORR)|ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 for target lesions using magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent imaging review (IIR). CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. ORR=CR+PR, was presented with 2-sided 95% confidence interval (CI) by the method of Clopper and Pearson.|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months|The Intent to Treat (ITT) Population included all participants who received at least one dose of the study drug and was the primary analysis set used for efficacy analyses.|||Percentage of participants||95% Confidence Interval|Number
2763393|NCT00784277|Primary|Spontaneous Bowel Movements Per Week (SBMs/Week)|The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.|Week 1 to Week 2|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).|||number of stools/week||Standard Deviation|Mean
2763394|NCT00784277|Primary|5-Day Sum of Pain Intensity Difference (SPID5)|"SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where 0 is no pain and 10 is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID)."|Day 1 to Day 5|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).|||Units on a scale||Standard Deviation|Mean
2763395|NCT00784238|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Millimeter (mm)||Standard Deviation|Mean
2763396|NCT00784238|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Millimeter (mm)||Standard Deviation|Mean
2763397|NCT00784238|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763416|NCT00784147|Other Pre-specified|Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 1.0 log10 reduction from Baseline in HIV-1 RNA.|Week 24||||percentage of patients|||Number
2763398|NCT00784238|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763399|NCT00784238|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2763400|NCT00784238|Primary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763401|NCT00784238|Primary|Drug Attitude Inventory (DAI-10) Total Score at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763402|NCT00784238|Primary|Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763403|NCT00784238|Primary|Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763417|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <400 Copies/mL at Week 24|This efficacy measure was assessed in the same manner as the primary efficacy analysis to determine the proportion of the total population achieving HIV-1 RNA levels <400 copies at Week 24 of the study.|Week 24||||percentage of patients|||Number
2763418|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <200 Copies/mL at Week 24|This measure was assessed in the same manner as the primary efficacy analysis for the proportion of patients achieving HIV-1 RNA levels below 200 copies/mL at Week 24 of the study.|Week 24||||percentage of patients|||Number
2763641|NCT00783263|Secondary|Number of Participants Who Reached Their Target LDL-C Level|Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.|6 weeks of treatment||||participants|||Number
2763404|NCT00784238|Primary|Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763405|NCT00784238|Primary|Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763406|NCT00784238|Primary|Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763407|NCT00784238|Primary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763408|NCT00784238|Primary|Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Week 24|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2763409|NCT00784225|Secondary|Number of Participants Who Underwent Cataract Extraction|Cataract extraction was defined as the surgical removal of an incident cataract.|Every 6 months, up to 7 years|Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.|||Participants|||Count of Participants
2763410|NCT00784225|Secondary|Number of Participants With Advanced AMD|Advanced AMD was defined as the occurrence of disciform scars, or geographic atrophy or retinal pigment epithelium (RPE) detachment in either or both eyes at AMD diagnosis.|Every 6 months, up to 7 years|Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.|||Participants|||Count of Participants
2763411|NCT00784225|Primary|Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30|Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.|Every 6 months, up to 7 years|Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.|||Participants|||Count of Participants
2763412|NCT00784225|Primary|Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)|Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)|Every 6 months, up to 7 years|Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.|||Participants|||Count of Participants
2763419|NCT00784147|Primary|The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.|"For the primary efficacy analysis, undetectable was defined as having HIV-1 RNA below the limit of assay detection at <50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here."|24 weeks||||percentage of participants|||Number
2763420|NCT00784134|Secondary|Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)|Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).|180 days|All the non-missing EuroQol scores at 180 days were analyzed.|||EuroQol score||Standard Deviation|Mean
2763421|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Recovery|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763422|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Participation|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763423|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Emotion|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763424|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Thinking|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763425|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Communication|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763426|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763427|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Hand Function|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763428|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Mobility|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763429|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Strength|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
2763430|NCT00784134|Secondary|Functional Status - National Institutes of Health Stroke Scale (NIHSS)|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).|180 days|All the non-missing NIHSS scores at 180 days were analyzed.|||NIHSS score||Inter-Quartile Range|Median
2763462|NCT00784134|Primary|Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
2763431|NCT00784134|Secondary|Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.|180 days|All the non-missing eGOS scores at 180 days were analyzed.|||% of participants with score>=4|||Number
2763432|NCT00784134|Secondary|Functional Status - Barthel Index|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.|180 days|All the non-missing Barthel scores at 180 days were analyzed.|||Barthel score||Standard Deviation|Mean
2763433|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763434|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763435|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763436|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763437|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763438|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
2763439|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
2763440|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All male patients with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763441|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All female patients with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763442|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were White with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
2763443|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
2763444|NCT00784134|Secondary|Predicting Hazards of Death by Treatment Group|Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
2763445|NCT00784134|Secondary|Adverse and Serious Adverse Events|Assessment of number of adverse and serious adverse events by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
2763446|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with systematic bleeds|||Number
2763447|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 72 Hours|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|72 hours|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with systematic bleeds|||Number
2763448|NCT00784134|Secondary|Safety/Mortality - Bacterial Brain Infections Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with brain infection|||Number
2763449|NCT00784134|Secondary|Safety/Mortality - Mortality Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Percentage of patients|||Number
2763450|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with infections|||Number
2763451|NCT00784134|Secondary|Intensity of Critical Care Management - Pneumonia|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with pneumonia|||Number
2763452|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with infections|||Number
2763453|NCT00784134|Secondary|Intensity of Critical Care Management - Shunts|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with shunts|||Number
2763454|NCT00784134|Secondary|Intensity of Critical Care Management - Pressors|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with pressors|||Number
2763455|NCT00784134|Secondary|Intensity of Critical Care Management - Mechanical Ventilation|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with ventilation|||Number
2763456|NCT00784134|Secondary|Intensity of Critical Care Management - ICP Management|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Percentage of events of ICP >20mmHg|||Number
2763457|NCT00784134|Secondary|Intensity of Critical Care Management - ICU Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Number of days||Inter-Quartile Range|Median
2763458|NCT00784134|Secondary|Intensity of Critical Care Management - Hospital Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Number of days||Inter-Quartile Range|Median
2763459|NCT00784134|Secondary|Clot Removal (Amount of Residual Blood)|Change in blood volume measured between stability scan and end of treatment scan|72 hours|All patients that were enrolled in CLEAR III were analyzed.|||odds ratio per time-weighted ml|||Number
2763460|NCT00784134|Secondary|All Cause Mortality||180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
2763461|NCT00784134|Primary|Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3|Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|30 days and 180 days|All the non-missing mRS scores at 30 days and 180 days were analyzed.|||Percentage of participants|||Number
2768733|NCT00748241|Secondary|Implant Failure|Total number of implants reported as failure.|3 years after implant placement|Number of failed implants based on total number of patients enrolled and total number of placed implants|||Number of implants|Participants||Number
2763463|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
2763464|NCT00784134|Primary|Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||mRS score||Inter-Quartile Range|Median
2763465|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis|Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
2763466|NCT00784095|Primary|QUAL-E Completion Sub-scale|A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
2763467|NCT00784095|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.|Baseline, 6 and 8 week follow ups||||units on a scale||Standard Deviation|Mean
2763468|NCT00784095|Secondary|Center for Epidemiology Studies - Depression Scale (CES-D)|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
2763469|NCT00784095|Secondary|Functional Status ADL|Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.|Baseline, 6 and 8 week follow ups||||units on a scale||Standard Deviation|Mean
2763470|NCT00784095|Primary|Quality of Life - Preparation|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
2763471|NCT00784043|Secondary|Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.|Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.|5 years|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here.||||||
2763472|NCT00784043|Secondary|Language Acquisition Over Time in Bilaterally Implanted Children.|Scores over time on the MacArthur communicative development inventory.|60 months post initial activation|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here||||||
2763473|NCT00784043|Primary|Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems|Speech perception scores will be compared pre-operatively and postoperatively.|60 months post initial stimulation|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here||||||
2763474|NCT00784030|Primary|Change in Urine cAMP Concentration and Urine Osmolality (UOsm)|Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours|pre- and post-water loading (2 hours)|Number of participants was deemed to be adequate for the purposes of this pilot study|||fold change in cAMP/UOsm (umol/UOsm)||Standard Error|Mean
2763475|NCT00783965|Primary|Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0||Baseline and 36 months||||participants|||Number
2763476|NCT00783965|Primary|Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter||Baseline and 36 months||||participants|||Number
2763477|NCT00783952|Primary|Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.|Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy.|6 months||||percentage of oxygen saturation||Standard Deviation|Mean
2763478|NCT00783835|Secondary|Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12|It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.|Screening (Week -2), 4 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763554|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 758 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763479|NCT00783835|Secondary|Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale|The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763480|NCT00783835|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763481|NCT00783835|Secondary|Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = Normal, not at all ill and a rating of 7 = Among the most extremely ill participants. Higher scores indicate worsening."|Screening (Week -2), 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763482|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763483|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 4|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763484|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763485|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 8|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763486|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4|Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 4|Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
2763487|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2765340|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
2763488|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763489|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
2763490|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
2763491|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
2763492|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763493|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763494|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763495|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763496|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763497|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763639|NCT00783263|Secondary|Number of Participants Who Reached the LDL-C Level of <70 mg/dl|Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|6 weeks of treatment||||participants|||Number
2763498|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763499|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763500|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763501|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763502|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763503|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763504|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763505|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763506|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763507|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763508|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763509|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763510|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763511|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization (TVR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763512|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763654|NCT00783094|Secondary|Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment|A listing of Adverse Events are reported in the Reported Adverse Event Section.|End of 12 weeks of double-blind through 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||participants|||Number
2763513|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763514|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763515|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763516|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763517|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763518|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763519|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763520|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763521|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763522|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763642|NCT00783263|Secondary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks||||percentage change||Standard Deviation|Mean
2763523|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763524|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763525|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763526|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763527|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763528|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763529|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763530|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763531|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763532|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763533|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763534|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763535|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763536|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763537|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763538|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763539|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763540|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763541|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763542|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
2763543|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
2763544|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
2763545|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 1123 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763546|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 758 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763547|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 days to 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763548|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|> 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763549|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763550|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763551|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763552|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763553|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 1123 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763555|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|>1 year (Very late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763556|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|31 days - 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763557|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|greater than 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763558|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763559|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763560|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763561|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763562|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763563|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763564|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763565|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
2763566|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763567|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763568|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
2763569|NCT00783796|Secondary|Distal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
2763570|NCT00783796|Secondary|Proximal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
2763571|NCT00783796|Secondary|In-segment Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
2763572|NCT00783796|Secondary|In-stent Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
2763573|NCT00783796|Secondary|Distal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
2763574|NCT00783796|Secondary|Proximal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
2763575|NCT00783796|Secondary|In-segment % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
2763576|NCT00783796|Secondary|In-stent % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
2763577|NCT00783796|Secondary|Distal Late Loss|Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeter||Standard Deviation|Mean
2763578|NCT00783796|Secondary|Proximal Late Loss|Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeter||Standard Deviation|Mean
2763579|NCT00783796|Secondary|In-segment Late Loss (LL)|In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.|240 Days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeters||Standard Deviation|Mean
2763580|NCT00783796|Secondary|In-Stent Late Loss|In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeters||Standard Deviation|Mean
2763655|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
2763581|NCT00783796|Secondary|Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)|Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.|From the start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.|||Percentage of Participants|||Number
2763582|NCT00783796|Secondary|Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)|Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.|From start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects|||Percentage of Lesions|Lesions||Number
2763583|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763584|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763585|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
2763586|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
2763587|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission."|Week 6 and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763588|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763589|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Response|"Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response."|Baseline, Week 6 and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763590|NCT00783718|Secondary|Induction Phase: Percentage of Participants With Mucosal Healing at Week 6|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763591|NCT00783718|Secondary|Induction Phase: Percentage of Participants in Clinical Remission at Week 6|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763592|NCT00783718|Primary|Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.|||percentage of participants||95% Confidence Interval|Number
2763593|NCT00783718|Primary|Induction Phase: Percentage of Participants With a Clinical Response at Week 6|"Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical response."|Baseline and Week 6|Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
2763594|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
2763595|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
2763596|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||mmol/L||Inter-Quartile Range|Median
2763597|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
2763643|NCT00783263|Primary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks||||percent change||Standard Deviation|Mean
2763598|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||pg/mL||Inter-Quartile Range|Median
2763599|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||pg/mL||Inter-Quartile Range|Median
2763600|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
2763601|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
2763602|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||umol/L||Inter-Quartile Range|Median
2763603|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
2763604|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
2763605|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
2763606|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||pg/mL||Inter-Quartile Range|Median
2768808|NCT00747617|Secondary|Serum Testosterone Responses to hCG|Mean serum testosterone levels before and after hCG injection. Serum testosterone levels before (-0.5 and 0 hrs) were averaged to achieve a single value|-0.5, 0, 24 hrs||||ng/ml||Standard Error|Mean
2763607|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||pg/mL||Inter-Quartile Range|Median
2763608|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
2763609|NCT00783705|Secondary|Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray||From baseline up to 6 months|Data were not collected due to a study team decision not to analyze this endpoint.||||||
2763610|NCT00783705|Secondary|Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia||From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.|||percentage of Ki67 expression level||Standard Deviation|Mean
2763611|NCT00783705|Secondary|Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment|The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.|||percentage change in number of lesions||Standard Deviation|Mean
2763612|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.|"The definitions of responses are:~Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease"|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
2763613|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.|"The definitions of responses are:~Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression."|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
2763614|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission"|Assessed every 4 weeks from Week 6 to Week 50, and at Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763615|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52|"Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
2763616|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2765723|NCT00768651|Primary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.|Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
2763617|NCT00783692|Secondary|Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6|C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).|Baseline and Week 6|Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.|||mg/L||Full Range|Median
2763618|NCT00783692|Primary|Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52|"Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.|||percentage of participants||95% Confidence Interval|Number
2763619|NCT00783692|Primary|Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
2763620|NCT00783692|Primary|Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
2763621|NCT00783614|Primary|Blood Markers of Inflammation, Endothelial Injury, and Thrombosis||changes from baseline to 6 months|Data measurements not obtained, as study terminated early due to poor enrollment||||||
2763622|NCT00783614|Primary|Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events|At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication|6 months|The number of participants with adverse events or reporting side effects|||participants|||Number
2763623|NCT00783432|Secondary|Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.|The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.|baseline, months 1,3,6,9 and 12/or early termination|Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.|||Units on a scale||Standard Deviation|Least Squares Mean
2763624|NCT00783432|Primary|Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.|Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.|baseline and 12 months/ET||||Participants|||Number
2763625|NCT00783432|Primary|Number of Participants Reporting Adverse Events|An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.|12 months|Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.|||Participants|||Number
2763640|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached Their Target LDL-C Level|Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.|6 weeks of treatment||||participants|||Number
2763626|NCT00783302|Secondary|Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.|"The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.~This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration."|Within 1 month, 6 months and 12 months post contrast administration.||||Number of Subjects|||Number
2763627|NCT00783302|Primary|The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
2763628|NCT00783302|Primary|The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
2763629|NCT00783302|Primary|The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
2763630|NCT00783302|Primary|The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|The subject follow-up period went from 1 month, 6 months and 12 months.|||Percentage of Subjects||95% Confidence Interval|Number
2763631|NCT00783289|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit||Day 0, 28, 56, 84, 112, and 161|Safety population included all participants who received at least 1 dose of the investigational product.|||participants|||Number
2763632|NCT00783289|Secondary|Terminal Phase Elimination Half-Life (t1/2) for Benralizumab|Terminal phase elimination half-life (t1/2) is the time measured for the serum concentration to decrease by one half.|Day 0, 1, 7, 28, 35, 56, 84, 112, and 161|Safety population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Standard Deviation|Mean
2763633|NCT00783289|Secondary|Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab|Area under the serum concentration-time curve from time-zero extrapolated to infinity postdose.|Day 0, 1, 7, 28, 35, 56, 84, 112, and 161|Safety population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram*day per milliliter||Standard Deviation|Mean
2763634|NCT00783289|Secondary|Maximum Observed Serum Concentration (Cmax) for Benralizumab||Day 0, 1, 7, 28, 35, 56, 84, 112, and 161|Safety population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2763635|NCT00783289|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab||Day 0, 1, 7, 28, 35, 56, 84, 112, and 161|Safety population included all participants who received at least 1 dose of the investigational product. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Full Range|Median
2763636|NCT00783289|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 161 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to Day 161|Safety population included all participants who received at least 1 dose of the investigational product.|||participants|||Number
2763637|NCT00783263|Secondary|Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels|Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.|Baseline to 6 weeks||||percentage change||Standard Deviation|Mean
2763638|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl|Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).|6 weeks of treatment||||participants|||Number
2763644|NCT00783224|Primary|Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks|The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.|Baseline to 2 weeks of treatment||||Units on a scale||Standard Error|Least Squares Mean
2763645|NCT00783198|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
2763646|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
2763647|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
2763648|NCT00783198|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
2763649|NCT00783198|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to Good Clinical Practice (GCP) issues.|||score on a scale||Standard Error|Mean
2763650|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint|Post residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||milliliter||Standard Deviation|Mean
2763651|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||microgram/liter||Standard Deviation|Mean
2763652|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 54-Week Endpoint||Baseline, 54-weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||beats per minute (bpm)||Standard Deviation|Mean
2763653|NCT00783094|Secondary|Change From Baseline in Blood Pressure During at 54-Week Endpoint||Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2765724|NCT00768651|Primary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
2763656|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
2763657|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
2763658|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 54 weeks|All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
2763659|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
2763660|NCT00783094|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
2763661|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 12 weeks|Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.|||Micrograms per liter||Standard Deviation|Mean
2763662|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint|Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||milliliters||Standard Deviation|Mean
2763663|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 12-Week Endpoint||Baseline, 12 Weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||beats per minute||Standard Deviation|Mean
2763664|NCT00783094|Secondary|Change From Baseline in Blood Pressure at 12-Week Endpoint||Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||mmHg||Standard Deviation|Mean
2763665|NCT00783094|Secondary|Number of Participants With Adverse Events During 12 Weeks of the Study|A listing of Adverse Events are reported in the Reported Adverse Event Section.|Baseline through 12 weeks|All randomized participants|||participants|||Number
2763666|NCT00783094|Secondary|Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement|Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.|Baseline, 12 weeks|Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.|||nanogram/milliliter||Standard Deviation|Geometric Mean
2763667|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||milliliters per second||Standard Error|Least Squares Mean
2763668|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
2763669|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
2763670|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
2763671|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
2763703|NCT00782639|Secondary|The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)|This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||Participants|||Number
2763672|NCT00783094|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
2763673|NCT00782834|Primary|Response Rate|Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.|1year||||Participants|||Number
2763674|NCT00782834|Primary|Progression Free Survival Rate at 6 Months|Number of participants that demonstrate progression free survival at 6 months|6 months||||Participants|||Number
2763675|NCT00782821|Secondary|Patient Allograft Survival at 12 Months|Patient's allograft was still functioning at 12 months post study enrollment|12 months||||participants|||Number
2763676|NCT00782821|Secondary|Patient Survival at 12 Months|Patient was still alive 12 months post study enrollment.|12 months||||participants|||Number
2763677|NCT00782821|Secondary|Acute Cellular Rejection by Banff '97 Criteria (Updated 2005)|"Acute cellular rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months||||participants|||Number
2763678|NCT00782821|Secondary|Antibody-mediated Rejection by Banff '97 Criteria (Updated 2005)|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria. Rejection due, at least in part, to documented anti-donor antibody ('suspicious for' if antibody not demonstrated); may coincide with categories 3, 4 and 5.~Grade I. ATN-like - C4d+, minimal inflammation Grade II. Capillary- margination and/or thromboses, C4d+ Grade III. Arterial - v3, C4d+"|6 months||||participants|||Number
2763679|NCT00782821|Primary|Incidence of Acute Rejection (Banff '97) or Antibody Mediated Rejection|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria.~Acute rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months||||participants|||Number
2763680|NCT00782795|Secondary|Insulin Sensitivity (%S)|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;|24 and 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||insulin sensitivity (%)||Standard Deviation|Mean
2763681|NCT00782795|Secondary|Missed Work|Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)|12, 24, 36, 48, 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||days||Standard Deviation|Mean
2763682|NCT00782795|Secondary|Hospitalizations|Mean number of hospitalizations within the prior 12 weeks|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||hospitalizations||Standard Deviation|Mean
2763683|NCT00782795|Secondary|Body Mass Index (BMI)|standard BMI defined as mass in kilograms divided by height in meters squared|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||kg/m^2||Standard Deviation|Mean
2763684|NCT00782795|Secondary|Pain|"Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)~What is your pain right now?~What is your typical or average pain in the last 12 weeks?~What is your pain level at its best in the last 12 weeks (how close to 0 does your pain get at its best)?~What is your pain level at its worst in the last 12 weeks (how close to 0 does your pain get at its worst)?"|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||units on a scale||Standard Deviation|Mean
2763685|NCT00782795|Secondary|Number and Percentage of Participants With Steatorrhea|Participants were counted as having steatorrhea if they had either a) positive qualitative fecal fat; or b) 72 hour quantitative fecal fat result with >7g fat in stool in 24hours|48 weeks||||Participants|||Count of Participants
2763686|NCT00782795|Secondary|Quality of Life|The SF36 (Short Form with 36 questions) QoL scoring system has 36 questions, comprising two main dimensions (Physical Health and Mental Health), further divided by 8 independent scales (Physical functioning, Role-Physical, Bodily pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health). The scales for general health and mental health overlap components of both the two main dimensions (Physical Health and Mental Health). The scales, including the total score and dimensions are scored as a number between 0 and 100, where 0 represents lower limits of functioning and 100 is best functioning possible. Data reported is the average total score.|24, 48 weeks|The 24 week data has two participants' data missing from each arm because it was not available.|||units on a scale||Standard Deviation|Mean
2763704|NCT00782639|Primary|The Number of Participants With Contrast-induced Nephropathy (CIN)|The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|48 to 72 hours After Injection of Contrast Media||||Participants|||Number
2768809|NCT00747617|Primary|Serum 17OHP Responses to hCG|Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects|24 hrs post dose|PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.|||ng/ml||Standard Error|Mean
2763687|NCT00782795|Secondary|Pancreas Ultrasound Appearance|"Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features:~Parenchymal Features - Only Body and Tail~Calcification (>3 hyperechoic foci >2 mm length & width with shadowing)~Lobularity (>3 well-circumscribed, >5mm structures)~Hyperechoic stranding (>3 hyperechoic lines >3mm in length, seen in > 2 different directions with respect to the imaged plane Parenchymal Features - Head, Body and Tail~Cyst (>2 mm diameter anechoic round or oval structure)~Hyperechoic foci (>3 reflectors, >3 mm long & wide, no shadowing) Ductal Features - Only Body and Tail~Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)~Irregular MPD contour (uneven and ectatic in its course)~Hyperechoic MPD margin (hyperechoic in >50% of MPD)~Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail~MPD calculi (hyperechoic foci with shadowing contained within MPD)"|48 weeks||||units on a scale||Inter-Quartile Range|Median
2763688|NCT00782795|Secondary|Insulin Resistance at 24 and 48 Weeks|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/|24, 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||HOMA2-IR||Standard Deviation|Mean
2763689|NCT00782795|Secondary|Beta-cell Function|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/|24, 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||Beta-cell function (%)||Standard Deviation|Mean
2763690|NCT00782795|Primary|Insulin Sensitivity Index for Glycemia at 48 Weeks.|"Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).~GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.~INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin."|48 weeks||||numeric index||Standard Deviation|Mean
2763691|NCT00782795|Primary|Insulin Sensitivity Index for Glycemia at 24 Weeks|"Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).~GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.~INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin."|24 weeks||||numeric index||Standard Deviation|Mean
2763692|NCT00782795|Primary|Glucose Tolerance at 48 Weeks|"Normal = normal plasma glucose and normal glucose tolerance (OGTT).~Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.~Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl."|48 weeks||||Participants|||Count of Participants
2763693|NCT00782795|Primary|Glucose Tolerance at 24 Weeks|"Normal = normal plasma glucose and normal glucose tolerance (OGTT).~Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.~Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl."|24 weeks||||Participants|||Count of Participants
2763694|NCT00782756|Secondary|Neurocognitive Outcome||through study completion, an average of 1 year|37 participants agreed to undergo neuropsychological evaluations.|||Participants|||Count of Participants
2763695|NCT00782756|Secondary|Progression Free Survival||through study completion, an average of 1 year||||months||Full Range|Median
2763696|NCT00782756|Primary|Number of Participants With Adverse Events|Safety assessments and toxicity grading will follow CTCAE Version 4 Grade|through study completion, an average of 1 year||||Participants|||Count of Participants
2763697|NCT00782717|Secondary|Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).|BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.|From Day 7 to Day 90 (or Early Exit)|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).|||Percentage of patients|||Number
2763698|NCT00782717|Primary|Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery|Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).|3 Months|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).|||Percentage of patients|||Number
2763699|NCT00782639|Primary|Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit|Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||milligrams per deciliter (mg/dL)|||Number
2763700|NCT00782639|Secondary|Number of Participants Who Died From Acute Renal Failure|This outcome measure provides the total number of participants who died as a result of acute renal failure.|Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)||||Participants|||Number
2763701|NCT00782639|Secondary|Number of Participants Requiring Dialysis|This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.|48 to 72 hours after injection of contrast media||||Participants|||Number
2763702|NCT00782639|Secondary|The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)|This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||Participants|||Number
2763717|NCT00782509|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS|||Point on scale||Standard Error|Mean
2763705|NCT00782626|Primary|Overall Response|Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy.Description: Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy. Response for target lesions (up to5) is based on 3 dimensions with an elliptical model volume used: 0.5L*W*T; (L) tumor extent in plane perpendicular to the selected plane; (W) longest measurement of the tumor width; (T) transverse measurement perpendicular to the width. CR is disappearance all target and non-target lesions and no new lesions. PR is >/= 65% decrease in sum of the products (referent baseline). PD 40% or more increase in any target lesion (referent smallest product observed on therapy). SD is none of the above. PR and SD classification as long as absent new lesions and unequivocal progression for non-target lesions else PD.|Disease evaluations (MRI brain, including volumetric analysis) occurred at baseline, at the end of course 1, every 3 courses during treatment up to 12 courses and at early treatment discontinuation.|The analysis dataset is comprised of all evaluable patients. All treated patients were evaluable.|||participants|||Number
2763706|NCT00782509|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.|||mmol/L||Standard Deviation|Mean
2763707|NCT00782509|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.|||percentage of participants|||Number
2763708|NCT00782509|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Mean number of moderate COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
2763709|NCT00782509|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Mean number of COPD exacerbations requiring hospitalization per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
2763710|NCT00782509|Secondary|Number of COPD Exacerbations|Mean number of COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
2763711|NCT00782509|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol.Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval..|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
2763712|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
2763713|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank.~The measured values presented are actually the First Quartile and 95% confidence interval."|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
2763714|NCT00782509|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS|||Point on scale||Standard Error|Mean
2763715|NCT00782509|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS|||Point on scale||Standard Error|Mean
2763716|NCT00782509|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS|||Point on scale||Standard Error|Mean
2763718|NCT00782509|Secondary|Weekly Mean of Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each 24 hour period during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
2763719|NCT00782509|Secondary|Weekly Mean of Daily Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each night during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
2763720|NCT00782509|Secondary|Weekly Mean of Daily Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each day during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
2763721|NCT00782509|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS|||L/min||Standard Error|Mean
2763722|NCT00782509|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS|||L/min||Standard Error|Mean
2763723|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
2763724|NCT00782509|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763725|NCT00782509|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763726|NCT00782509|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
2763727|NCT00782509|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763728|NCT00782509|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763729|NCT00782509|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours aftertreatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763730|NCT00782509|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
2763731|NCT00782509|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
2763732|NCT00782509|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
2763733|NCT00782509|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
2763734|NCT00782509|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
2763735|NCT00782509|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS|||Liter||Standard Error|Mean
2763736|NCT00782509|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
2763737|NCT00782509|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
2763738|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763739|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763740|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
2763741|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763742|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763743|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763744|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763745|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763746|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
2763747|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763765|NCT00782496|Secondary|Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2|Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.|Over six month period|63 surveys were available for analysis.|||percent of Level 2 participants|||Number
2763748|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763749|NCT00782509|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763750|NCT00782509|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
2763751|NCT00782509|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
2763752|NCT00782509|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
2763753|NCT00782509|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
2763754|NCT00782509|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
2763755|NCT00782509|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
2763756|NCT00782509|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
2769192|NCT00744380|Primary|Time From Study Drug Initiation to Tracheal Extubation||Duration of ICU stay, for up to 24 weeks|The analysis only includes patients successfully extubated for at least 72 hours. Eight subjects were excluded.|||days||Inter-Quartile Range|Median
2763757|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763758|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763759|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763760|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763761|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763762|NCT00782509|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
2763763|NCT00782509|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS|||Liter||Standard Error|Mean
2763764|NCT00782509|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.|||Liter||Standard Error|Mean
2763766|NCT00782496|Primary|Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features||6 months|For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.|||number of post-prandial tests per week||Standard Error|Mean
2763767|NCT00782483|Primary|Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|Three treatments up to one year, whichever is first|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.||||||
2763768|NCT00782418|Primary|Change From Baseline in Insulin Concentration||Pre and Post glucose infusion|All subjects treated|||μIU(insulin)/mL||Full Range|Least Squares Mean
2763769|NCT00782418|Primary|Change From Baseline in C-peptide Concentration||Pre and Post glucose infusion|All subjects treated|||ng/mL||Full Range|Least Squares Mean
2763770|NCT00782418|Primary|Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose|"Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate.~Insulin Secretion Rate (ISR)/ Blood Glucose (BG)"|Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose|All subjects treated|||(ng/min) / (mg/dL)||Full Range|Geometric Mean
2763771|NCT00782379|Secondary|Disease Free Survival at Day 100|Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.|Day 100|17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100|||participants|||Number
2763772|NCT00782379|Secondary|Disease Free Survival at 12 Months|Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.|12 months|14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year|||participants|||Number
2763773|NCT00782379|Secondary|Overall Survival at 12 Months|Overall survival, defined as a patient being alive after transplant, is without regard to disease status.|12 months|20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year|||participants|||Number
2763774|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|13 patients had chimerism drawn at Day 90|||participants|||Number
2763775|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 60|18 patients had chimerism drawn at Day 60|||participants|||Number
2763776|NCT00782379|Secondary|Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)||Day 100|2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality|||participants|||Number
2763777|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|18 patients had Day 30 chimerism drawn|||participants|||Number
2763778|NCT00782379|Secondary|Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)|Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.|1 year|6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality.|||participants|||Number
2763779|NCT00782379|Secondary|Overall Survival at Day 100|Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.|Day 100|20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival|||participants|||Number
2763780|NCT00782379|Primary|Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)|Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence|Day 100|17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease|||participants|||Number
2763781|NCT00782379|Primary|Incidence of Graft Rejection for Patients at Day 100|Number of patients who experienced graft rejection by Day 100|Day 100|20 patients were treated and able to be analyzed for graft rejection|||participants|||Number
2763782|NCT00782340|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days||||mmHg||Standard Deviation|Mean
2763783|NCT00782340|Secondary|Clinician-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days||||participants|||Number
2763784|NCT00782340|Secondary|Patient-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days||||participants|||Number
2763785|NCT00782340|Secondary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
2763786|NCT00782340|Secondary|Change in Activities Involving Walking a Short Time (OHDAS Item 3)|OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
2763787|NCT00782340|Secondary|Change in Activities Involving Standing a Short Time (OHDAS Item 1)|OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
2763788|NCT00782340|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score|OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
2763789|NCT00782340|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
2763790|NCT00782340|Primary|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from randomization, negative numbers represent improvement from randomization in OHQ score."|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
2763791|NCT00782288|Secondary|Clinically Significant Changes in the Microbiology of Sputum in Subjects|Count of clinically significant changes in sputum microbiology during the Treatment phase (Day 1 to Day 28) to include any new acquisition of B. cepacia or new acquisition of any multiple resistant organism.|28 days|There were no significant changes in the microbiology of sputum in any subjects over the course of treatment.|||participants|||Number
2763792|NCT00782288|Secondary|Clinically Significant Alterations in ECG Readings|Safety indices included an assessment for the number of clinically significant alterations in the subjects ECG readings from Day 1 to Day 28.|28 days|Count of clinically significant alterations in the ECG in all subjects during the Treatment Phase of the study.|||participants|||Number
2763793|NCT00782288|Secondary|Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.|Rhinoprobe was used to collect nasal epithelial cells. The cells were collected pre and post-treatment and placed in Trizol for RNA isolation then used to measure the effect of digitoxin on gene expression. The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). The accession number for that data is GSE76347 (data available Dec 2018).|Day 0 and Day 28|The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). Results can be found under the accession number GSE76347. One subject's pair of specimens in the placebo group was not collected.|||participants|||Number
2763794|NCT00782288|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.|Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days).|Baseline and Day 28|All subjects had blood labs for ESR drawn on Visits 1,3,4 and 5. The changes in median ESR were calculated during the Treatment Period (28 days).|||mm/hr||Inter-Quartile Range|Median
2763795|NCT00782288|Secondary|Changes in C Reactive Protein (CRP) During Treatment.|Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5.|Baseline and Day 28|All subjects had blood labs for CRP drawn on Visits 1,3,4 and 5. The changes in median CRP were calculated during the Treatment Period (28 days).|||mg/dL||Inter-Quartile Range|Median
2763796|NCT00782288|Primary|Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).|The change in log 10 neutrophil cell count from Day 28 minus Day 1 (during the treatment period) expressed as log (10^4 neutrophil/mL).|28 days (Day 28 minus Day 1)|The change in neutrophil cell count from Day 1 to Day 28 was performed using a Kruskal-Wallis equality of populations rank test. The cells counts are expressed as log 10 (neutrophil cell/mL).|||log 10 (neutrophil cell/mL)||Inter-Quartile Range|Median
2763797|NCT00782288|Primary|Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The neutrophil counts were measured in the induced sputum of participants in each group on study 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1- Day 42)|Neutrophil cell counts were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between the placebo and the two digitoxin dose levels.|||log 10 (neutrophil cells/mL)||Inter-Quartile Range|Median
2763798|NCT00782288|Primary|Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).|Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1.|28 days (Day 28 minus Day 1)|For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed.|||log10 (pg/mL)||Inter-Quartile Range|Median
2763799|NCT00782288|Secondary|Change in WBC (White Blood Cell) Count by Group During Treatment Period|Safety indices included changes in FEV1 (lung function), changes in WBC, alterations in ECG and sputum microbiology. There were no significant alterations in the ECG in any subjects over the course of the study. There were no subjects who acquired multiple resistant changes in microbiology of sputum and no acquisition of B. cepacia in any subjects. Therefore, these data were not analyzed. The median changes in FEV1 and median changes in WBC, ESR and CRP are reported.|Baseline and Day 28|Safety indices included changes in WBC during treatment for each group.|||K/cu mm||Inter-Quartile Range|Median
2763800|NCT00782288|Secondary|Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).|"CFQ-R is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms. Developed specifically for use in patients with a diagnosis of cystic fibrosis. There are 9 Quality of life domains: physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions and 3 symptom scales: weight, respiratory, and digestion.~Scaling of items is done via 5 distinct 4-point Likert scales. Scores for each domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. Based on clinician judgment of global clinical change, a moderate change was a standardized effect size of 0.50 units and an important change was a standardized effect size of 0.80 units evaluating pre- and post-treatment for CF exacerbation. Mean changes in CFQ-R Scores by Group were evaluated between Visit 6 and Visit 1, by Domain."|Baseline and Day 42|Mean change in CFQ-R scores from Visit 1 to Visit 6, by domain.|||mean change of scores on a scale||Standard Deviation|Mean
2763801|NCT00782288|Secondary|Safety Indices Including Change in FEV1 in Stable CF Patients.|Safety indices included changes in FEV1 (forced expiratory volume in 1 second), changes in WBC (white blood cell count), alterations in ECG and sputum microbiology. The median changes in FEV1 are reported.|Baseline and Day 28|Median changes in FEV1 in L by group for the 28 days of treatment.|||liters||Inter-Quartile Range|Median
2763802|NCT00782288|Secondary|Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.|Digitoxin serum levels were drawn on Days 1 (pre-dose), 7, 14, 21 and 42. The range of digitoxin levels for each visit is listed and the number of subjects who had that level are marked by group (placebo, low dose and high dose).|Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42|Subjects had serum digitoxin levels drawn at Day 1 (pre-dose) with no levels observed, as expected. Digitoxin was drawn on Day 7, 14, 21 and 42 to determine the number of subjects with a detectable level of digitoxin (ng/mL) in serum by group.|||participants|||Number
2763803|NCT00782288|Primary|Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1 to Day 42)|Sputum was collected for Il-8 biomarkers on Days 1,14, 21, 28 during the treatment phase and at Day 42. Measures were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between placebo and the two doses.|||log 10 (pg/mL)||Inter-Quartile Range|Median
2763804|NCT00782275|Secondary|Overall Survival|Overall survival (OS) is defined from the date of registration to date of death, or censored at the date the participant was last known alive. OS is estimated based on the Kaplan-Meier method.|Median follow-up for survival in this study cohort is 56 months.|The analysis dataset is comprised of all treated participants.|||months||90% Confidence Interval|Median
2763805|NCT00782275|Secondary|Objective Response Rate|Objective response (OR) rate is the percentage of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment; Treatment continued until disease progression or unacceptable toxicity. Median (range) of treatment duration for this study cohort was 5 cycles (1-39) [1 cycle=28days].|The analysis dataset is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
2763806|NCT00782275|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the percentage of participants absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
2763807|NCT00782210|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.|||mmol/L||Standard Deviation|Mean
2763808|NCT00782210|Secondary|Changes in Safety Parameters Related to Treatment|Occurrence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.|||percentage of participants|||Number
2763809|NCT00782210|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.||||Number of COPD exacerbations||Standard Error|Mean
2769193|NCT00744328|Secondary|Infant Serum Concentrations of Estradiol in 3 Treatment Arms|As expected due to being stopped and therefore underpowered|monthly||||pg/mL||Standard Deviation|Mean
2763810|NCT00782210|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD exacerbations||Standard Error|Mean
2763811|NCT00782210|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD exacerbations||Standard Error|Mean
2763812|NCT00782210|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
2763813|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
2763814|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
2763815|NCT00782210|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS|||Point on scale||Standard Error|Mean
2763816|NCT00782210|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS|||Point on scale||Standard Error|Mean
2763817|NCT00782210|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS|||Point on scale||Standard Error|Mean
2763818|NCT00782210|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS|||Point on scale||Standard Error|Mean
2763819|NCT00782210|Secondary|Weekly Mean Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
2763820|NCT00782210|Secondary|Weekly Mean Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
2763821|NCT00782210|Secondary|Weekly Mean Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
2763822|NCT00782210|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS|||L/min||Standard Error|Mean
2763823|NCT00782210|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS|||L/min||Standard Error|Mean
2763842|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763824|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
2763825|NCT00782210|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763826|NCT00782210|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763827|NCT00782210|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
2763828|NCT00782210|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763829|NCT00782210|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763830|NCT00782210|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763831|NCT00782210|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
2763832|NCT00782210|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
2763870|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763833|NCT00782210|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
2763834|NCT00782210|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
2763835|NCT00782210|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
2763836|NCT00782210|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS|||Liter||Standard Error|Mean
2763837|NCT00782210|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
2763838|NCT00782210|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
2763839|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763840|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763841|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
2763843|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763844|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763845|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763846|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763847|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
2763848|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763849|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763850|NCT00782210|Secondary|Peak FEV1 (0-3h) Response At Day 1|"Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.~Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by- visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect."|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
2763851|NCT00782210|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
2763871|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763852|NCT00782210|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
2763853|NCT00782210|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
2763854|NCT00782210|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
2763855|NCT00782210|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
2763856|NCT00782210|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
2763857|NCT00782210|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
2763858|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
2763859|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
2763872|NCT00782184|Secondary|Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2765725|NCT00768651|Primary|C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
2763860|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
2763861|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
2763862|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|FAS|||Liter||Standard Error|Mean
2763863|NCT00782210|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
2763864|NCT00782210|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS|||Liter||Standard Error|Mean
2763865|NCT00782210|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.|||Liter||Standard Error|Mean
2763866|NCT00782184|Secondary|Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763867|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B/A-1 Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763868|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein A-1||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763869|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763907|NCT00781963|Primary|Sleep Onset Latency|Mean time to fall asleep based on 7-day sleep diary.|Six months after randomization||||Minutes||95% Confidence Interval|Mean
2763873|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763874|NCT00782184|Secondary|Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763875|NCT00782184|Secondary|Percent Change From Baseline in Triglycerides||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763876|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763877|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <100 mg/dL|Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
2763878|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <77 mg/dL|Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
2763879|NCT00782184|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL)-C||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2763880|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goals of <70 mg/dL|Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
2763881|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events|Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled|||number of events|||Number
2763882|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|3 years post-surgery||||implants|Number of Implants||Number
2763883|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|2 years post-surgery|The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants.|||implants|Number of Implants||Number
2763884|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|1 years post-surgery||||implants|Number of Implants||Number
2763885|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|20-23 weeks post-surgery||||implants|Number of Implants||Number
2763886|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected|Patients affected by AE Patients affected by related/ unknown AE|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled|||patients affected|||Number
2763887|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|3 years post-surgery||||implants|Number of Implants||Number
2763888|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|2 years post-surgery||||implants|Number of Implants||Number
2763889|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|1 year post-surgery|Number of implants placed. Implants from drop-outs are not included|||implants|Number of implants||Number
2763890|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation|20-23 Weeks post-surgery||||implants|Implants||Number
2763908|NCT00781950|Secondary|Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.||1 year||||mmHg||Standard Error|Mean
2763891|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 3 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
2763892|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 2 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
2763893|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 1 year post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
2763894|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
2763895|NCT00782067|Secondary|Histopathologic Response|Histopathologic response was summarized to demonstrate the change from baseline in percentage of mast cell infiltrations in the Bone Marrow (BM) and related serum tryptase levels.|Up 5 years|Primary Efficacy Population (PEP); for each patient, the best improvement relative to Baseline was considered.|||Percentage of participants|||Number
2763896|NCT00782067|Secondary|Long-term Safety and Tolerability of Midostaurin|Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)|Up to 30 days after last dose of study treatment|Safety Set (SS)|||Percentage of participants|||Number
2763897|NCT00782067|Secondary|Median Time to Overall Survival (OS)|The Overall Survival (OS) is defined as the time from start of treatment to the date of death due to any cause.|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response and the Full Analysis Set (FAS), which consisted of all patients who received at least one dose of study drug were considered.|||Months||95% Confidence Interval|Median
2763898|NCT00782067|Secondary|Median Time to Progression-Free Survival (PFS)|The Progression-free survival (PFS) is defined as the time from start of treatment to the date of the first documented and confirmed progression or death due to any cause.|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response, was considered.|||Months||95% Confidence Interval|Median
2763899|NCT00782067|Secondary|Median Time to Response (TTR)|The Time to response (TTR) was defined as the time from start of treatment until the date of onset of confirmed response (MR or PR).|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response, was considered.|||Months||Full Range|Median
2763900|NCT00782067|Secondary|Median Time to Duration of Response (DoR)|The Duration of response (DoR) was defined as the time from first onset of confirmed response (MR or PR) to the date of first documented and confirmed progression or death due to ASM/MCL.|Up 5 years|Primary Efficacy Population (PEP), which consisted of all participants with a confirmed response, was considered.|||Months||95% Confidence Interval|Median
2763901|NCT00782067|Primary|Percentage of Participants With Overall Response Rate (ORR)|"Overall Response Rate (ORR) was defined as the percentage of participants who classified as confirmed responders (Major Response (MR) or Partial Response (PR)) by the adjudication of the SSC and based on a Modified Valent Criteria.~A major responder had complete resolution of at least one C-Finding and no progression in other C-Findings. A partial responder showed a measurable improvement in one or more C-Finding(s) without confirmed progression in other C-Findings. A C-Finding was a Clinical Finding, which was considered by the investigator and corroborated by the Study Steering Committee (SSC) Chairperson or designee, attributable to the mast cell disease component and not the associated hematological clonal non-mast cell lineage disease (AHNMD) component or any other cause."|6 months|Primary Efficacy Population: participants assigned to study treatment who met diagnostic criteria for aggressive systemic mastocytosis or mast cell leukemia and presented with at least 1 measurable C-Finding at study entry and/or participants with transfusion dependent anemia due to their underlying disease at study entry as confirmed by the SCC.|||Percentage of participants||95% Confidence Interval|Number
2763902|NCT00781963|Primary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 - 21. A total score > 8 indicates poor sleep quality.|Six months after randomization||||units on a scale||95% Confidence Interval|Mean
2763903|NCT00781963|Primary|Sleep Efficiency From Wrist Actigraphy|Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.|Six months from randomization||||percentage of time asleep while in bed||95% Confidence Interval|Mean
2763904|NCT00781963|Primary|Sleep Efficiency From Sleep Diary|Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.|Six months after randomization||||percentage of time asleep while in bed||95% Confidence Interval|Mean
2763905|NCT00781963|Primary|Total Wake Time|Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.|Six months after randomization||||Minutes||95% Confidence Interval|Mean
2763906|NCT00781963|Primary|Wake After Sleep Onset|Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.|Six months after randomization||||Minutes||95% Confidence Interval|Mean
2763910|NCT00781937|Secondary|Binge Eating Scale Scores by Week and Severity|Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)|Week 0, week 50 and week 57|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||scores on a scale||Standard Deviation|Mean
2763911|NCT00781937|Secondary|Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)|Number of subjects using concomitant medications at Week 0 and Week 56, respectively|Week 0 and week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||Subjects|||Number
2763912|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)|Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage point||Standard Error|Least Squares Mean
2763913|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||pmol/L||Standard Error|Least Squares Mean
2763914|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
2763915|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)|Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||proportion||Standard Error|Least Squares Mean
2763916|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)|Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percent change||Standard Error|Least Squares Mean
2763917|NCT00781937|Secondary|Change From Baseline in Body Mass Index (BMI)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg/m^2||Standard Error|Least Squares Mean
2763918|NCT00781937|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||cm||Standard Error|Least Squares Mean
2763919|NCT00781937|Secondary|Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56|Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.|Week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763920|NCT00781937|Secondary|Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||nmol/L||Standard Error|Least Squares Mean
2763921|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Total Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
2763922|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
2763923|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Triglycerides|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
2763924|NCT00781937|Secondary|Change From Baseline in Pulse||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||beats/minute||Standard Error|Least Squares Mean
2763925|NCT00781937|Secondary|Change From Baseline in Blood Pressure||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmHg||Standard Error|Least Squares Mean
2763926|NCT00781937|Secondary|Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 68|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg||Standard Error|Least Squares Mean
2763927|NCT00781937|Secondary|Change From Baseline in Fasting Weight|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg||Standard Error|Least Squares Mean
2763928|NCT00781937|Secondary|Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763929|NCT00781937|Secondary|Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763930|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763931|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763932|NCT00781937|Secondary|Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763933|NCT00781937|Primary|Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763934|NCT00781937|Primary|Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0|Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
2763935|NCT00781937|Primary|Mean Percentage Change in Fasting Body Weight From Baseline|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage||Standard Error|Least Squares Mean
2763936|NCT00781911|Secondary|Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2||18 months|Zero participants were analyzed due to no data collection due to low number of clinical responses observed.||||||
2763937|NCT00781911|Secondary|Serum Anti-Cixutumumab Antibody Assessment||18 months|Zero participants were analyzed due to no data collection due to low number of clinical responses observed.||||||
2763938|NCT00781911|Secondary|PK: Volume at Steady State (Vss) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
2763939|NCT00781911|Secondary|PK: Clearance (CL) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
2763940|NCT00781911|Secondary|PK: Area Under Concentration (AUCinf) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
2763941|NCT00781911|Secondary|PK: Half-life (t 1/2) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
2763942|NCT00781911|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
2763943|NCT00781911|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|18 months|All participants who had received at least one dose of study drug.|||Participants|||Count of Participants
2763944|NCT00781911|Secondary|Percentage of Participants With a Biochemical Response Rate|Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.|From Start of Treatment Up to 18 Months|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline Chromogranin A and Gastrin data.|||percentage of participants||95% Confidence Interval|Number
2763945|NCT00781911|Secondary|Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)|Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.|From Start of Treatment Baseline to Disease Progression (Up to 18 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2763946|NCT00781911|Primary|Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months|Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.|From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)|All participants who received at least one dose of study drug. Participants censored in the carcinoid tumor arm were 8 and in the islet cell carcinoma arm were 4.|||percentage of participants||95% Confidence Interval|Number
2763947|NCT00781898|Primary|Relapse|A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.|6 months||||Participants|||Count of Participants
2763948|NCT00781859|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2763949|NCT00781859|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.|The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.|Day 28|Intention-To-Treat (ITT), Last Observation Carried forward (LOCF)|||percentage of participants|||Number
2763950|NCT00781768|Primary|Complete Response Rates Among Standard of Care and Combination Therapy Groups.|Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.|14 days|179 patients receiving autologous and allogeneic hematopoietic stem cell transplants.|||Participants|||Count of Participants
2763951|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 2|A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
2763952|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 1|A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
2763953|NCT00781599|Secondary|Cotinine Verified 7 Day Point Prevalence Smoking Abstinence|Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.|Month 3|A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
2763987|NCT00780741|Secondary|Proportion of Participants With Office Probing Success 6 Months After Randomization|The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.|Randomization to 6 months|Participants randomized to immediate office probing who underwent office probing.|||proportion with treatment success||95% Confidence Interval|Number
2763954|NCT00781599|Primary|Percent Compliance With Chantix|Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.|Months 1, 2, 3|Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.|||Percentage of Participants||Standard Deviation|Mean
2763955|NCT00781508|Secondary|The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.|A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.|Measured 1 hr after oral administration of sildenafil 50 mg||||meters||Standard Deviation|Mean
2763956|NCT00781508|Primary|Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil|Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e|Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil|All patients (10) that completed the protocol were analyzed.|||E/e' ratio||Standard Deviation|Mean
2763957|NCT00781456|Secondary|Mean Number of Days of Bleeding or Spotting|Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.|91-day treatment period|Safety population with available data|||days||Standard Deviation|Mean
2763958|NCT00781456|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.~The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.~Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.~A serious adverse event (SAE) is one that met any one of the following criteria:~Fatal or life threatening~Requires or prolongs in patient hospitalization~Results in persistent or significant disability/incapacity~Congenital anomaly / birth defect~Important medical event."|Up to 15 weeks|Safety population, consisting of all participants who received at least one dose of study drug.|||participants|||Number
2763959|NCT00781456|Secondary|Change From Baseline in Headache Impact Test|"The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.~HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.~There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated."|Baseline and Week 15|Analysis was not performed due to an error in the administration of the test.||||||
2763960|NCT00781456|Secondary|Change From Baseline in Migraine Disability Assessment|"The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.~The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).~The MIDAS score is classified into four grades of severity:~0 to 5: MIDAS Grade I, Little or no disability~6 to 10: MIDAS Grade II, Mild disability~11 to 20: MIDAS Grade III, Moderate disability~21+: MIDAS Grade IV, Severe disability"|Baseline and Week 15|Intent-to-treat population with available data.|||units on a scale||Standard Deviation|Mean
2763961|NCT00781456|Secondary|Percentage of Participants Who Required Rescue Medications During the Study Period|Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.|Baseline, Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.|||percentage of participants|||Number
2763962|NCT00781456|Secondary|Change From Baseline in Average Migraine Severity|"Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.~Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity."|Baseline and Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.|||units on a scale||Standard Error|Least Squares Mean
2763963|NCT00781456|Secondary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months|The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.|Baseline, Month1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time point.|||percentage of participants|||Number
2763964|NCT00781456|Primary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period|The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.|Baseline (25-35 days before Day 1) and Days 1-91|Intent-to-treat population|||percentage of participants|||Number
2763965|NCT00781391|Secondary|Adjudicated Bleeding Events|"Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.~Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements."|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|Safety-analysis set, on-treatment period|||number of participants with event|||Number
2763966|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality|Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
2763967|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding|Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
2763968|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality|Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..|||number of participants with event|||Number
2763969|NCT00781391|Primary|Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).|Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
2763970|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
2763971|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).|||number of participants with event|||Number
2763972|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).|||Number of participants with event|||Number
2763973|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).|||number of participants with event|||Number
2763974|NCT00781365|Primary|Mean Diastolic Blood Pressure|Mean diastolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months||||mm Hg||95% Confidence Interval|Mean
2763975|NCT00781365|Primary|Mean Systolic Blood Pressure|Systolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months||||mmHg||95% Confidence Interval|Mean
2763976|NCT00781365|Primary|Blood Pressure Control|Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)|Baseline, 6 months, 12 months, 18 months||||percentage of participants||95% Confidence Interval|Number
2763977|NCT00781326|Primary|Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]|Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.|End of Phase I (at 24 weeks)||||units on a scale||Standard Deviation|Mean
2763979|NCT00781079|Secondary|Quality of Life Interview, Brief Version|Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable (all items averaged together). The score ranges from 1 to 5, with 1 meaning more quality of life.|immediately before the intervention (BL), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
2763980|NCT00781079|Secondary|Illness Management and Recovery Scale: Client Self-Rating|The Illness Management and Recovery Scale (IMR) has 15 items (rated on 5-point behaviorally anchored scales) that assess progress toward goals, knowledge about mental illness, involvement with significant others and self-help, time in structured roles, impairment in functioning, symptom distress and coping, relapse prevention and hospitalizations, use of medications, and alcohol and drug use. A total IMR score is made of the mean of the items and has demonstrated good internal consistency, stability (test-retest after two weeks), and convergent validity, correlating with the Recovery Assessment Scale and the Colorado Symptom Index. The total score is reported on the scale of 1 to 5 with higher scores mean better recovery.|12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
2763981|NCT00781079|Secondary|Recovery Self-Assessment: Person in Recovery Version|Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment. Each item ranges from 1 to 5. The total score (all 36 items averaged together) also is reported on that scale, with higher meaning more recovery.|immediately before the intervention (BL), and 12 months post intervention (Post)|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
2763982|NCT00781079|Secondary|Patient Activation Measure|"The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient's knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., I know what each of my prescribed medications do) on a scale from 1 (disagree strongly) to 4 (agree strongly). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI."|immediately before the intervention (BL), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
2763983|NCT00781079|Secondary|Mental Health Recovery Measure (MHRM)|The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery. Range of total score is 0 to 144, with higher scores meaning better recovery.|immediately before the intervention (BL), and 12 months post intervention (Post).|comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|||units on a scale||Standard Deviation|Mean
2763984|NCT00781079|Primary|BASIS-R|The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).|immediately before the intervention (BL), and 12 months post intervention (Post).||||units on a scale||Standard Deviation|Mean
2763985|NCT00780962|Primary|Number of Participants With Contrast-induced Nephropathy|Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration.|48-72 hours|Out of 399 subjects who consented to participate in the study, only 357 (89.4%) had a second blood creatinine levels measurement done between 48 to 72h.|||Participants|||Count of Participants
2763986|NCT00780910|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2763988|NCT00780741|Secondary|Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.|Randomization to 6 months|All participants who had unilateral nasolacrimal duct obstruction at baseline, who were randomized to the deferred facility probing group, and who completed the 6-month visit (timed from randomization). The analysis followed the intent to treat principle.|||proportion of participants||95% Confidence Interval|Number
2763989|NCT00780741|Secondary|Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age|Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.|Randomization to 18 months of age.|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.|||months of symptoms||Full Range|Mean
2763990|NCT00780741|Primary|Cost of Treatment|Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.|Randomization to 18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.|||US dollars||Full Range|Mean
2763991|NCT00780741|Primary|Proportion of Participants With Treatment Success|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.|18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the primary outcome visit at 18 months of age were analyzed. The analysis followed the intent-to-treat principle.|||proportion of participants|||Number
2763992|NCT00780715|Primary|HbA1c Change|Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)|6 months|Modified Intention to treat|||absolute change in %HbA1c||Standard Deviation|Mean
2763993|NCT00780676|Primary|Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)|Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.|Tumor status assessed every 8 weeks during therapy, up to 6 months|Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to either group, and only treated participants (30) included in analysis.|||Percentage of Participants|||Number
2763994|NCT00780572|Primary|Time to Intervention Once an ADE Alert Has Fired in CPRS||From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.||||hours to intervention||Inter-Quartile Range|Median
2763995|NCT00780559|Other Pre-specified|Change in Physical Activity (PA) at 12 Months as Measured by the CHAMPS (Community Health Activities Model Program for Seniors) Activity Scale|Physical Activity measured by CHAMPS provides an estimated caloric expenditure of subject based on weight and weekly physical activity, as assessed by the questionnaire. Change in physical activity is determined by the difference in daily caloric expenditure at baseline and 12 months.|Baseline and 12 Months||||kcal/day||Standard Error|Least Squares Mean
2763996|NCT00780559|Secondary|Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh|Measure of the number of skin fibers/mm in the lower extremity (proximal thigh) at 12 months|12 Months||||fibers/mm||Standard Error|Least Squares Mean
2763997|NCT00780559|Secondary|Intraepidermal Nerve Fiber Density (Distal Leg)|Measure of the number of skin fibers/mm in the lower extremity (distal leg) at 12 months|12 Months||||fibers/mm||Standard Error|Least Squares Mean
2763998|NCT00780559|Primary|Change in 6-Minute-Walk Test Measured in Feet Between Baseline and 12 Months||Baseline and 12 Months||||feet||Standard Error|Least Squares Mean
2763999|NCT00780559|Primary|Six Minute Walk (6MW) Test|Measures distance covered by participant when walking at a brisk pace without running for six minutes in feet.|Six Months||||feet||Standard Error|Least Squares Mean
2764000|NCT00780494|Secondary|Vascular Endothelial Growth Factor Tumor Response Biomarker|The detected blood levels for tumor biomarker vascular endothelial growth factor (VEGF) were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.|9 weeks|Studies published during the conduct of this study demonstrated that this assessment was not useful, and the samples were not collected. Accordingly, there is no data to be analyzed.||||||
2764001|NCT00780494|Secondary|CEA and CA 19.9 Tumor Response Biomarkers|The detected blood levels for tumor biomarkers CEA and CA 19.9 were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.|9 weeks|Based on the objective results, it was determined that the any results from tumor biomarker analyses would be of little value, and the measurement for tumor biomarkers in the collected samples were not conducted. Accordingly, there is no data to be analyzed.||||||
2764051|NCT00779909|Secondary|Urinary Calcium/Creatinine Ratio|Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is <0.14.|week 4, week 7, week 12||||ratio||Standard Deviation|Mean
2764002|NCT00780494|Secondary|Objective (Overall) Therapeutic Response|"Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions, and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays/radiologic scan. Response was determined based on the criteria below.~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Objective Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is provided as the number of participants who achieved each of the defined responses, with objective (overall) response defined as the sum of CR and PR. The outcome is reported as values without dispersion."|12 months|Data for clinical response was not available for all participants. Response data are only reported for participants for whom response is known.|||Participants|||Count of Participants
2764003|NCT00780494|Secondary|Overall Survival (OS)|Overall survival (OS) will be assessed from time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The outcome is presented as the median survival in days with standard deviation.|7.5 years|Data were available for all participants. Participants remaining alive were censored at last date assessed.|||Days||Standard Deviation|Median
2764004|NCT00780494|Secondary|Adverse Events ≥ Grade 3 and Related to Bevacizumab|Toxicity was assessed as the number of adverse events ≥ Grade 3 and also possibly, probably, or definitely related to bevacizumab. The outcome is reported as the total number of applicable events, and as the number of events that were a hematologic toxicity; a non-hematologic toxicity; which are numbers without dispersion.|12 months|All participants were included in this analysis.|||Adverse events|||Number
2764005|NCT00780494|Primary|Progression-Free Survival (PFS)|"Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below.~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Objective Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria.~Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included."|12 months|Those participants who did not receive follow-up at 12 months were considered lost-to-follow-up and not evaluable for progression, and were censored from the analysis.|||Participants|||Count of Participants
2764006|NCT00780481|Secondary|Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.||Single Study Day|Data was lost||||||
2764007|NCT00780481|Secondary|Radial Artery Elasticity||Single Study Visit|Data was lost||||||
2764008|NCT00780481|Secondary|Peak FMD||Single Study Day|Data Lost||||||
2764009|NCT00780481|Primary|Peak t-PA Release|tPA Release|Single Study day|Data was lost||||||
2764010|NCT00780455|Secondary|Quality of Life Assessed by Use of Self-questionnaire (SEP-59)|SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764011|NCT00780455|Secondary|Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)|FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764012|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits|"Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764052|NCT00779909|Secondary|Serum Calcium|The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL.|week 7, week 12||||mg/dl||Standard Deviation|Mean
2764143|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Score|To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764013|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit|Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764014|NCT00780455|Secondary|Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit|The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764015|NCT00780455|Secondary|Covered Distance Gain Between MR2 Visit and MR3 Visit|"Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764016|NCT00780455|Primary|Rhythm Change During 6 Minutes Walking Test||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764017|NCT00780455|Primary|Distance of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764018|NCT00780455|Primary|Time of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764019|NCT00780455|Primary|Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
2764020|NCT00780442|Primary|Cocaine Craving Scale|"Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating Not at all and 10 indicating Extremely."|Immediately following cue exposure|Cocaine dependent individuals|||Units on a scale||Standard Deviation|Mean
2764021|NCT00780416|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2764022|NCT00780403|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).|||participants|||Number
2764023|NCT00780338|Secondary|Prevention Performance - Total Score (Percent Change)|"A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or components) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from highly faithful=7 to highly divergent=1 from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (highly faithful=7 to highly divergent=1 from ideal performance)"|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. Percent change was calculated from Pre to Mid, Mid to Post, PRE to POST.|||percent change||Full Range|Mean
2764024|NCT00780338|Secondary|Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)|"The Assets efficacy scale is the sum of 10 items using a three-point scale (1=would need a great deal of help to carry out this task, 2=could carry out this task, but would need some help, 3=could carry out this task without any help) asking about activities associated with doing assets activities. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"|||percentage of the highest possible score||Standard Error|Least Squares Mean
2765726|NCT00768651|Primary|Acute Insulin Responses to Arginine After 6 Months of Therapy|An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.|6 months|||||||
2764025|NCT00780338|Primary|Prevention Capacity-Assets Efficacy (Intent to Treat)|"Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. Assets efficacy scale is the sum of 10 items using a three-point scale (1=would need a great deal of help to carry out this task, 2=could carry out this task, but would need some help, 3=could carry out this task without any help) asking about activities associated with doing the Developmental Assets model. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale."|Baseline, mid (1 year), post (2 years)|Despite drop outs, all the data was used.|||percentage of the highest possible score||Standard Deviation|Mean
2764026|NCT00780338|Secondary|Prevention Capacity - Assets Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=never to 7=very often) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
2764027|NCT00780338|Primary|Prevention Capacity - ASSETS Behaviors (Intent to Treat)|"This scale is the sum of 11 items with seven-point scales (1=never to 7=very often) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale."|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
2764028|NCT00780338|Primary|Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)|"This scale is the sum of 11 items with seven-point scales (1=never to 7=very often) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale."|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
2764029|NCT00780338|Secondary|Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)|"This scale is the sum of 11 items with seven-point scales (1=never to 7=very often) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
2764030|NCT00780338|Secondary|Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)|"The GTO efficacy scale is the sum of 10 items using a three-point scale (1=would need a great deal of help to carry out this task, 2=could carry out this task, but would need some help, 3=could carry out this task without any help) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"|||percentage of the highest possible score||Standard Error|Least Squares Mean
2764031|NCT00780338|Secondary|Prevention Capacity - GTO Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=never to 7=very often) assessing the frequency with which respondents engaged in GTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
2764032|NCT00780338|Primary|Prevention Capacity - GTO Behaviors (Intent to Treat)|"This scale is the sum of 11 items with seven-point scales (1=never to 7=very often) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale."|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
2764144|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Positive Score|To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764033|NCT00780338|Secondary|Prevention Performance - Total Score (Descriptive Means)|"A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or components) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from highly faithful=7 to highly divergent=1 from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (highly faithful=7 to highly divergent=1 from ideal performance)"|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. These means are presented at the timepoints in which they were collected.|||units on a scale|Participants|Full Range|Mean
2764034|NCT00780338|Primary|Prevention Capacity-GTO Efficacy (Intent to Treat)|"Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. GTO efficacy scale is the sum of 10 items using a three-point scale (1=would need a great deal of help to carry out this task, 2=could carry out this task, but would need some help, 3=could carry out this task without any help) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale."|Baseline, mid-point (1 year), posttest (2 years)|Despite drop outs, all the data was used.|||percentage of the highest possible score||Standard Deviation|Mean
2764035|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|24 months after surgery||||Percentage of implants|Participants||Number
2764036|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|12 months after surgery||||Percentage of implants|Participants||Number
2764037|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|6 months after surgery||||Percentage of implants|Participants||Number
2764038|NCT00780234|Primary|6-month Histology Score|Biopsies were classified into one of the following 8 World Health Organization defined categories to classify the endobronchial lesion and assign a score according to the following scale: 1 = normal bronchial epithelium; 2 = reserve cell hyperplasia; 3 = squamous metaplasia without atypia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ (CIS); and 8 = invasive carcinoma. 1 represents the best outcome and 8 represents the worst outcome.|6 months|Although 76 subjects had a 6-month bronchoscopy (39 pioglitazone, 37 placebo), only 64 subjects (34 pioglitazone, 30 placebo) had matched biopsy pairs with non-normal tissue at baseline. Of these 64, 29 were former smokers (15 pioglitazone, 14 placebo), which was the a priori group for the primary analysis.|||Units on a scale||Standard Deviation|Mean
2764039|NCT00780208|Secondary|Number of Participants With Positive Drug Screen|Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens|8 weeks||||Participants|||Count of Participants
2764040|NCT00780208|Primary|ADHD Symptom Severity|Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
2764041|NCT00780143|Primary|Response Rate|To determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.|Until disease progression or unacceptable toxicity|not enough efficacy data were retrieved||||||
2764042|NCT00780143|Primary|Dose Limiting Toxicity|To determine the dose limiting toxicity (DLT) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.|Until disease progression or unacceptable toxicity|The Dose Limiting Toxicity not occurred|||Participants|||Count of Participants
2764043|NCT00780143|Primary|Máximum Tolerate Dose|To determine the maximum tolerated dose (MTD) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.|Until disease progression or unacceptable toxicity|The Máximum Tolerate Dose level was not reached||||||
2764044|NCT00780026|Secondary|Number of Participants With Venous Thrombotic Complications|Number of participants who were diagnosed with portal vein thrombosis post surgery|12 months||||Participants|||Count of Participants
2764045|NCT00780026|Secondary|Number of Participants With Biliary Complications|Number of participants who experienced bile leak or biliary Stricture|12 months||||Participants|||Count of Participants
2764046|NCT00780026|Secondary|Number of Participants With a Need for Hemodialysis|Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;|12 months post surgery||||Participants|||Count of Participants
2764047|NCT00780026|Secondary|Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU|Requirements for blood transfusion counted as a binary variable yes/no per participant|12 months||||Participants|||Count of Participants
2764048|NCT00780026|Secondary|Hospital Length of Stay||12 months||||days||Inter-Quartile Range|Median
2764049|NCT00780026|Primary|Number of Participants With One Year Survival Post Transplant||12 months||||Participants|||Count of Participants
2764050|NCT00780026|Primary|Infection Rates|Number of participants who sustained an infection after surgery|30 days||||Participants|||Count of Participants
2764053|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12|"GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device.~GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm."|week 8 and week 12||||pg/site||Standard Deviation|Mean
2764054|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Volume|GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above.|week 8 and week 12||||ul||Standard Deviation|Mean
2764055|NCT00779909|Secondary|Maxillary Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual's score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
2764056|NCT00779909|Secondary|Mandibular Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual's score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
2764057|NCT00779909|Primary|Maxillary Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
2764058|NCT00779909|Primary|Mandibular Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
2764059|NCT00779909|Primary|Proportion of Sites That Bleed on Probing|Assessment of the bleeding index will be performed on oral and buccal sites. The periodontal probe will be moved gently across the marginal gingiva of all teeth of a quadrant. After 30 seconds, absence or presence of bleeding will be scored. The number of bleeding sites is used to calculate the gingival bleeding score.|end of 4 week experimental gingivitis phase|Data for this outcome measure was not collected on any of the participants as it was overlooked and failure to collect these data did not come to the attention of the PI until after all follow-ups were completed.||||||
2764060|NCT00779870|Secondary|Correlation Between ASM Mass and Airway Hyper-responsiveness (PC20)||at the time of bronchoscopy, an average of 1 hour|No data collected||||||
2764061|NCT00779870|Primary|Difference in Intracellular Oxidative Stress Mechanisms From ASM Between Groups|Expression of Nrf2 protein|at time of bronchoscopy, an average of 1 hour||||relative expression unit||Full Range|Mean
2764062|NCT00779870|Primary|Difference in ASM Proliferation, Migration and Cytokine Release Between Groups||at time of bronchoscopy, an average of 1 hour|Data not collected||||||
2764063|NCT00779870|Primary|Difference in ASM Mass Between Groups||at time of bronchoscopy, an average of 1 hour|No data collected||||||
2764064|NCT00779857|Primary|Percent of Patients With Complete Occlusion of the Left Atrial Appendage.|The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.|3 Months Post Procedure|The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.|||percentage of subjects||95% Confidence Interval|Number
2764065|NCT00779857|Primary|Rate of Device Related Serious Adverse Events|The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.|Discharge/30 days Post Procedure|The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.|||Number of participants||95% Confidence Interval|Number
2764066|NCT00779779|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Throughout the study period (Day 0 to Month 3 or 4)|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2764067|NCT00779779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2764068|NCT00779779|Secondary|Number of Subjects Reporting Each Type of Solicited General Symptoms|Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.|During the 8-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2764069|NCT00779779|Primary|"Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea"|"Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.~Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.~Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day."|During the 8-day solicited follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2764070|NCT00779766|Secondary|Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status|Titers were expressed as geometric mean titers calculated on all subjects, HPV-16 assay cut-off value was defined as greater than or equal to 8 EL.U/mL at Months 0, 7, 12 and 24 and greater than or equal to 19 EL.U/mL at Months 36, 48 and 72. HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at Month 0, 7, 12 and 24 and ≥ 18 EL.U/mL at Months 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ the assay cut-off value prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.|||Titers||95% Confidence Interval|Geometric Mean
2764071|NCT00779766|Secondary|Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at PRE vaccination, Month 7, 12 and 24 and ≥ 18 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 7 EL.U/mL and 18 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.|||Participants|||Count of Participants
2764072|NCT00779766|Secondary|Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-16 assay cut-off value was defined as greater than or equal to (≥) 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and ≥ 19 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 8 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.|||Participants|||Count of Participants
2764073|NCT00779766|Secondary|Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2765727|NCT00768651|Primary|HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy|HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.|6 months|||||||
2764074|NCT00779766|Secondary|Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and Missing.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764075|NCT00779766|Secondary|Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and MIssing.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764076|NCT00779766|Secondary|Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies|Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764077|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764078|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764079|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764080|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764081|NCT00779766|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Day 0 to Month 72|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764082|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764083|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|Within Days 0-29 after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764084|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764085|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity|Within Days 0-29 after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764086|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764087|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764088|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas.|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764089|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0 degrees Celsius) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination, Related = symptoms assessed by the investigator as causally related to study vaccination, Grade 3 symptoms = prevented normal activity, Grade 3 urticaria = distributed on at least 4 body areas.|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764090|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764091|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling/redness above (>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764092|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling or Redness = swelling/redness above (>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2765728|NCT00768651|Primary|Change From Baseline on Gastrin Level After One Month of Therapy|Gastrin levels were measured at baseline and at one month by method (manufacturer).|Baseline and One month|||||||
2764093|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling or redness above (>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2764094|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type|CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764095|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type|CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764096|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection|CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764097|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection|CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764098|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type|Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764099|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection|Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. US).|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764100|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type|Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|At Months 24,48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764161|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Quinine Study Day 11.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours after the morning dose on Day 11||||msec|||Number
2764101|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type|Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764102|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type|Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Subjects|||Number
2764103|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18|Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Subjects|||Number
2764104|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18|Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764105|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18|HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24,48, 57 and 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764106|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72|CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.|At Month 72|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764107|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57|CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.|At Month 57|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764128|NCT00779584|Secondary|Time of MK-8776 Cmax (Tmax)|The time of Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||hr||Standard Deviation|Mean
2764108|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48|CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.|At Month 48|The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2764109|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24|CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.|At Month 24|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable subjects for whom efficacy data were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
2764110|NCT00779701|Primary|Time to Achieve Glycemic Control||Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.||||Minutes||Standard Deviation|Mean
2764111|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
2764112|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
2764113|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
2764120|NCT00779675|Secondary|Change From Baseline in Mean PASI Score|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.|Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98|The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98.|||Score on a Scale||95% Confidence Interval|Mean
2764114|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
2764115|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
2764116|NCT00779675|Secondary|Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase.|||Participants|||Number
2764117|NCT00779675|Secondary|Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at each time point.|||Participants|||Number
2764118|NCT00779675|Secondary|Change From Baseline in Mean Dermatology Life Quality Index (DLQI)|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Baseline, Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at baseline and at each time point.|||Score on a Scale||Standard Error|Mean
2764119|NCT00779675|Secondary|Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase|PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase.|||Participants|||Number
2764127|NCT00779584|Secondary|MK-8776 Terminal Phase Half-Life (t1/2)|The t1/2 of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||hr||Standard Deviation|Mean
2764121|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.|Week 98|The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.|||Participants|||Number
2764122|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period|Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.|Week 98|The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.|||Participants|||Number
2764123|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.|Week 50|The population includes all participants that achieved a PASI-50 response at treatment Week 14.|||Participants|||Number
2764124|NCT00779675|Secondary|Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.|Week 50|The population consists of all participants that achieved PASI-75 response by treatment Week 14.|||Participants|||Number
2764125|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.|Week 50|The population consists of all participants that achieved a PASI-90 response at treatment Week 14.|||Participants|||Number
2764126|NCT00779675|Primary|Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
2770132|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 54||Baseline and week 54|Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2764129|NCT00779584|Secondary|MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)|AUC0-last was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. AUC0-last was calculated by the linear trapezoidal method.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||ng*hr/mL||Standard Deviation|Mean
2764130|NCT00779584|Secondary|MK-8776 Maximum Plasma Concentration (Cmax)|The Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||ng/mL||Standard Deviation|Mean
2764131|NCT00779584|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximatey 66 weeks|The population consisted of all participants who received at least one dose of MK-8776.|||Participants|||Number
2764132|NCT00779584|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who experienced an AE is presented.|Up to approximately 72 weeks (Up to approximately 6 weeks after last dose of study treatment)|The population consisted of all participants who received at least one dose of MK-8776.|||Participants|||Number
2764133|NCT00779584|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)|During Cycle 0, a DLT was defined as: CTCAE v 3.0 Grade 3 neutropenia or thrombocytopenia lasting ≥3 days; any CTCAE v 3.0 Grade 4 neutropenia or thrombocytopenia; neutropenic fever; any CTCAE v. 3.0 ≥ Grade 3 QT interval corrected by Fridericia (QTcF) prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s); delay in Cycle 1 Day 1 beyond 3 weeks due to continuing toxicity. During Cycle 1, a DLT was defined as: CTCAE v 3.0 Grade 4 neutropenia that persists for ≥7 days; neutropenic fever; CTCAE v 3.0 Grade 4 thrombocytopenia; CTCAE v 3.0 ≥ Grade 3 thrombocytopenia with bleeding; any CTCAE v 3.0 QTc ≥ Grade 3 QTcF prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s).|Through Cycle 0 and Cycle 1 (Up to 42 days)|The population consisted of all participants who were evaluable for DLT assessment (i.e., completed Cycle 0 and Cycle 1).|||Participants|||Number
2764134|NCT00779558|Secondary|Need for Antibiotics||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||participants|||Number
2764135|NCT00779558|Secondary|Cardiac ICU Length of Stay||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||days||Standard Deviation|Mean
2764136|NCT00779558|Secondary|Days to Extubation||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||days||Standard Deviation|Mean
2764137|NCT00779558|Secondary|Total PRBCs Transfused||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||mL/kg||Standard Deviation|Mean
2764138|NCT00779558|Primary|Thrombosis|Echocardiographic evidence of thrombosis while on study drug|While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days||||participants|||Number
2764139|NCT00779506|Secondary|Global Assessment of Functioning (GAF) Score|To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764140|NCT00779506|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764141|NCT00779506|Secondary|Clinical Global Impression (CGI) Score|The Clinical Global Impression - Severity (CGI-S) and - illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient's current clinical state. The CGI-I is scored to rate the patient's change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764142|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score|To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764145|NCT00779506|Primary|The Change in Positive and Negative Syndrome Scale(PANSS)Total Score|"PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210.~Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method"|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
2764146|NCT00779467|Secondary|Cesarean Delivery|percentage of subjects in each group requiring a ceserean delivery|occurence||||percentage of subjects in each group|||Number
2764147|NCT00779467|Secondary|Patient Satisfaction Scores|maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia|within 24 hours post delivery||||units on a scale||Inter-Quartile Range|Median
2764148|NCT00779467|Secondary|Bromage Score|the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|until delivery|Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|||units on a scale||Standard Deviation|Mean
2764149|NCT00779467|Secondary|Pruritus|the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|until delivery|the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|||units on a scale||Standard Deviation|Mean
2764150|NCT00779467|Secondary|Shivering|maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably|until delivery||||units on a scale||Standard Deviation|Mean
2764151|NCT00779467|Secondary|Sedation|average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy|until delivery||||units on a scale||Standard Deviation|Mean
2764152|NCT00779467|Secondary|Nausea|average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable|until delivery||||units on a scale||Standard Deviation|Mean
2764153|NCT00779467|Primary|Amount of Drug Consumed Per Hour in Each Group(Arm)|Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)|until delivery|median hourly total bupivacaine consumption in each group, in ml/hr|||milliliters per hour||Inter-Quartile Range|Median
2764154|NCT00779402|Primary|Number of Subjects That Met Biochemical Failure Status|time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.|Every 3 months post-infusion||||Participants|||Count of Participants
2764155|NCT00779402|Primary|Time to Biochemical Failure Cumulative Incidence Percentile|Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL|Every 3 months post-infusion|Number of subjects that met biochemical failure criteria.|||Months||95% Confidence Interval|Median
2764156|NCT00779311|Secondary|Determination of Quality of Life (QoL) as Indicated by Patient Care Monitor (PCM) Data Among Patients on This Regimen|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The frequency of patient reported severe (rated as >=7) symptoms reported from the set of symptoms assessed by the PCM.|The PCM questionnaire was administered on day 1 of each cycle (approximately every 2 weeks) during study treatment.|The number of patients out of the total sample of 8 patients who reported severe (rated as >=7) symptoms as assessed by the PCM. Symptoms with 0 patients reporting severe symptoms have been omitted.|||Participants|||Number
2764157|NCT00779311|Secondary|Determination of Progression Free Survival (PFS) Among Patients on This Regimen|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first.||||Months||95% Confidence Interval|Median
2764158|NCT00779311|Primary|Determination of the Maximum Tolerated Dose (MTD) of Sorafenib When Given in Combination With mFOLFOX6 and Bevacizumab|The MTD of sorafenib was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first 2 cycles of treatment (i.e., the first 4 weeks of treatment since cycle length is 2 weeks)|3 patients (pts) were enrolled at DL 1 with 1/3 experiencing DLT, so 3 additional pts were enrolled at DL 1. 2 of those additional pts were not evaluable for DLT assessment and were replaced. 2 more pts were enrolled for a total of 8 pts, and 1 of these pts experienced a DLT. All of the 8 pts enrolled received sorafenib at DL 1.|||mg every other day|||Number
2764159|NCT00779285|Primary|Cardiac Events|A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).|Every 4 weeks during 6 cycles.||||Cardiac Events|||Number
2764160|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Theophylline Co-administered With Quinine, Study Day 12.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours post-dose on Day 12||||msec|||Number
2764514|NCT00775658|Primary|The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.|||cm2||Standard Deviation|Mean
2764162|NCT00779259|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug-hr/mL||Standard Deviation|Mean
2764163|NCT00779259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug-hr/mL||Standard Deviation|Mean
2764164|NCT00779259|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug/mL||Standard Deviation|Mean
2764165|NCT00779246|Secondary|Vancomycin Resistant Enterococcal Infection or Colonization||During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||Participants|||Count of Participants
2764166|NCT00779246|Secondary|Number of Participants With Central Line Associated Bloodstream Infection||During ICU stay up to six months|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||participants|||Number
2764167|NCT00779246|Primary|Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection|Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).|During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||participants|||Number
2764168|NCT00779155|Primary|"Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects on State."|The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.|Baseline and 8 weeks|Analysis was by intention to treat and all enrolled subjects completed the entire protocol.|||scores on a scale||Standard Deviation|Mean
2764169|NCT00779142|Secondary|Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.||1 month||||Participants|||Count of Participants
2764170|NCT00779142|Secondary|Number of Participants With Increase in Visual Acuity (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection||1 month||||Participants|||Count of Participants
2764171|NCT00779142|Primary|30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection||4 weeks||||participants|||Number
2764172|NCT00779116|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).|||Participants|||Number
2764173|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|End of Study treatment (Hour 72)|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
2764174|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 48|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
2764515|NCT00775658|Primary|The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)||||cm2||Standard Deviation|Mean
2764175|NCT00779038|Secondary|Number of Participants With Physician Global Assessment of Method of Pain Control|"The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
2764176|NCT00779038|Secondary|Number of Participants With Nurse Global Assessment of Method of Pain Control|"The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
2764177|NCT00779038|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|"The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
2764178|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24|Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 24|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
2764179|NCT00779025|Secondary|Number of Sensations Experienced by Female Subjects - Overall|Number of sensations experienced by female subjects, based on two applications of the product for each subject.|1 Week|Intention to Treat|||Sensations|Participants||Number
2764180|NCT00779025|Secondary|Number of Sensations Experienced by Male Subjects - Overall|Number of sensations experienced by male subjects, based on two applications of the investigational product.|1 Week||||Sensations|Participants||Number
2764181|NCT00779025|Primary|Number of Participants Showing Change From Baseline in Irritation Scores|Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions|1 week|Analysis was per Intention to Treat (ITT)|||Participants|||Number
2764182|NCT00778999|Secondary|Number of Good Quality Embryos|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
2764183|NCT00778999|Secondary|Number of Fertilized (2PN) Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
2764184|NCT00778999|Secondary|Number of Follicles on Day of hCG|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
2764185|NCT00778999|Secondary|Number of Follicles on Stimulation Day 8|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
2764186|NCT00778999|Secondary|Number of Mature Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
2764187|NCT00778999|Primary|Total Number of Oocytes|The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response|12 weeks|Intent-to-treat, defined as all randomized subjects who received recombinant follicle stimulating hormone|||Number of oocytes||Standard Deviation|Mean
2764188|NCT00778921|Secondary|Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)||12 weeks|||||||
2764189|NCT00778921|Secondary|Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group||8 weeks|Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)|||Participants|||Number
2764190|NCT00778921|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study||Baseline and Week 8|full analysis set|||mm Hg||Standard Error|Least Squares Mean
2764191|NCT00778921|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study||Baseline and Week 8|full analysis set|||mm Hg||Standard Error|Least Squares Mean
2764192|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764193|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764516|NCT00775645|Other Pre-specified|Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy|Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
2764194|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764195|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764196|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|"Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764197|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|"Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2764198|NCT00778895|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2764199|NCT00778895|Secondary|Seroconversion Factor for HI Antibodies|"The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
2764200|NCT00778895|Secondary|Number of Subjects Seroprotected Against HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2764201|NCT00778895|Secondary|Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2764202|NCT00778895|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2764203|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764204|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764205|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764206|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764207|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2764208|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2764209|NCT00778895|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2764210|NCT00778869|Primary|Number of Genes Which Were Differentially Expressed|Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.|14 weeks||||Number of genes|||Number
2764232|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population|Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16||||participants|||Number
2764211|NCT00778830|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|Safety population consisted of all the enrolled subjects who received at least one dose of study treatment.|||Subjects|||Number
2764212|NCT00778830|Secondary|Overall Survival (OS) Time|OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2764213|NCT00778830|Secondary|Progression-Free Survival (PFS) Time|PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2764214|NCT00778830|Primary|Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)|Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)|Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment.|||Percentage of subjects|||Number
2764215|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks|Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount).|48 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
2764216|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks|Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount).|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
2764217|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks|Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount).|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
2764218|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks|Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount).|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
2764219|NCT00778817|Secondary|Response at 48 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|48 weeks||||percentage of participants|||Number
2764220|NCT00778817|Secondary|Response at 18 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|18 weeks||||percentage of participants|||Number
2764242|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set|For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
2764221|NCT00778817|Secondary|Response at 12 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|12 weeks||||percentage of participants|||Number
2764222|NCT00778817|Secondary|Response at 6 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|6 weeks||||percentage of participants|||Number
2764223|NCT00778817|Secondary|Best Response Rates|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|Up to 6 months||||percentage of participants|||Number
2764224|NCT00778817|Primary|Progression-free Survival Rate at 18 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
2764225|NCT00778817|Primary|Progression-free Survival Rate at 12 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
2764226|NCT00778817|Primary|Progression-free Survival Rate at 6 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
2764227|NCT00778648|Secondary|Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs||Baseline, months 2,4,6,8.|||||||
2764228|NCT00778648|Primary|Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.||within 6 months (after 2 months run-in period)||||Number of days||95% Confidence Interval|Mean
2764229|NCT00778622|Other Pre-specified|Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population|Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively.|||participants|||Number
2764230|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population|Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16||||mm Hg||Standard Deviation|Mean
2764231|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population|Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Safety population included 125, 122, 124 participants in each arm, respectively. Participants missing from analysis for change at Week 16 for Heart Rate were 17, 18, 20 participants in the normal, overweight, obese arms, respectively.|||beats/min||Standard Deviation|Mean
2764233|NCT00778622|Other Pre-specified|Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population|Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Number of participants (normal, overweight, obese, respectively) who were missing values and were not included in the Week 16 analysis for the following serum chemistry tests: ALT = 14, 11, 13; AST = 14, 11, 13; total BR = 14, 11, 13; creatinine = 14, 12, 13; BUN = 14, 12, 13; UA = 14, 12, 13.|||participants|||Number
2764234|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population|Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; WBC (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Week 16|Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|||participants|||Number
2764235|NCT00778622|Other Pre-specified|Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population|Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity.|Day 1 to Week 16|All participants enrolled in the study and who received at least 1 dose of Glucophage XR.|||participants|||Number
2764236|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 78, 70, and 72 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mg/L||95% Confidence Interval|Mean
2764237|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.|Baseline to Week 16|Full Analysis Set (FAS) population = 111, 111, 112 in normal, overweight, obese participants respectively. For this outcome measure, 84, 79, and 75 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||U/mL||95% Confidence Interval|Mean
2764238|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 102, 95, and 85 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mg/L||95% Confidence Interval|Mean
2764239|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 4, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
2764240|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 2, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
2764241|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set|Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 9 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
2764243|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set|Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) included enrolled participants,who took at least 1 dose of drug and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 1, and 1 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
2764244|NCT00778622|Primary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)|Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.|Baseline to Week 16|Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.|||percentage of hemoglobin||95% Confidence Interval|Mean
2764245|NCT00778375|Secondary|Overall Response Rate (CR, CRp/CRi and PR)|IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|Of 119 enrolled, one participant was not evaluable for response.|||Percentage of Participants|||Number
2764246|NCT00778375|Secondary|Event Free Survival (EFS)|EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.|Follow up up to 5 years/60 months.|Of 119 enrolled, one participant was not evaluable for response.|||Months||Full Range|Median
2764247|NCT00778375|Primary|Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|One participant of 119 treated was not evaluable for response. Twenty-two participants required re-induction.|||Participants|||Number
2764248|NCT00778375|Primary|Median Overall Survival (OS)|Overall survival (OS): Time from date of treatment start until date of death due to any cause.|Evaluated from treatment date until date of death, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.|||Months||Full Range|Median
2764249|NCT00778375|Primary|Complete Remission (CR) Rate for First 60 Participants|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days|The outcome population consisted of first sixty participants enrolled between October 2008 and January 2010, of whom 59 were evaluable for response.|||Percentage of Participants|||Number
2764250|NCT00778375|Primary|Disease-free (DFS) or Relapse-free Survival (RFS) Time|Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.|Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.|||Months||Full Range|Median
2764251|NCT00778336|Secondary|Description of Treatments by Thrombotic Condition|The # of patients that were exposed to each treatment at least once in the given thrombotic condition.|Index Procedure||||Participants|||Number
2764252|NCT00778336|Secondary|Rethrombosis|The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).|3 Month Follow Up||||Participants|||Number
2764253|NCT00778336|Primary|Change From Baseline to Final Angiographic Results|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician:~complete occlusion (> 90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length);~patent (Without visable thrombus or occlusion).~The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value."|Index Procedure ( pre-endovascular treatment and post-endovascular treatment)|Intention to Treat (ITT)|||Occlusion Index||Standard Error|Mean
2764254|NCT00778310|Primary|Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo|Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.|Placebo and Drug day, 1-2 weeks apart|The number who completed both fMRI one week apart (crossover study, scanned twice|||Face-Shape BOLD signal difference||Standard Deviation|Mean
2764255|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline to the time complete milk tolerance was established|Data were not collected and therefore no analyses could be performed.||||||
2764256|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline, Month 12, Month 24, and Month 36|Data were not collected and therefore no analyses could be performed.||||||
2764257|NCT00778258|Secondary|Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk|Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.|Month 36|Randomized and comparison participants|||percent participants|||Number
2764258|NCT00778258|Secondary|Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.|Baseline, Month 12, Month 24, Month 36|Intent-to-treat|||Ratio||Inter-Quartile Range|Median
2764259|NCT00778258|Secondary|Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat participants who achieved tolerance|||months||Standard Deviation|Mean
2764260|NCT00778258|Secondary|Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat|||cells/µL||Inter-Quartile Range|Median
2764261|NCT00778258|Secondary|Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat|||kUa/L||Inter-Quartile Range|Median
2764262|NCT00778258|Secondary|Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.|Baseline|Intent-to-treat|||percentage of max basophil degranulation||Inter-Quartile Range|Median
2764415|NCT00776984|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Days||Standard Error|Mean
2764263|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat|||percentage of participants|||Number
2764264|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.|12 months, 24 months, and 36 months|Randomized intent-to-treat|||percentage of participants|||Number
2764265|NCT00778258|Secondary|Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months|Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.|12 months, 24 months|Randomized intent-to-treat|||participants|||Number
2764266|NCT00778258|Primary|Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat|||participants|||Number
2764267|NCT00778167|Primary|Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)|Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.|From time of first dose up to 28 days|Patients were evaluated with history, physical examination, vital signs, and blood tests weekly through cycle 1 and on day 1 of each subsequent cycle. Incidence and severity of AEs were collected at each study visit and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.|||Participants|||Number
2764268|NCT00778102|Secondary|Percentage of Participants With Complications Related to Second Resective Surgery|Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent second resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (Second Surgery Subpopulation): All participants who underwent a second resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.|||percentage of participants|||Number
2764269|NCT00778102|Secondary|Percentage of Participants With Complications Related to First Resective Surgery|Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent first resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (First Surgery Subpopulation): All participants who underwent a first resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.|||percentage of participants|||Number
2764270|NCT00778102|Secondary|Time to Response|Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||months||95% Confidence Interval|Median
2764271|NCT00778102|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as [number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2764272|NCT00778102|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.|Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population|||months||95% Confidence Interval|Median
2764273|NCT00778102|Secondary|Percentage of Participants Who Died||Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population|||percentage of participants|||Number
2764274|NCT00778102|Secondary|Progression-Free Survival (PFS)|PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||months||95% Confidence Interval|Median
2764275|NCT00778102|Secondary|Percentage of Participants Experiencing Death or Disease Progression|PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as [number of participants with event divided by the number of participants analyzed] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||percentage of participants|||Number
2764276|NCT00778102|Secondary|Relapse-Free Survival (RFS)|RFS was defined as the time from curative resection (complete resection [R0] or microscopic residual tumor [R1]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.|||months||95% Confidence Interval|Median
2764277|NCT00778102|Secondary|Percentage of Participants Experiencing Relapse Following Curative Resection|Among participants with curative resection (complete resection [R0] or microscopic residual tumor [R1]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as [number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.|||percentage of participants|||Number
2764278|NCT00778102|Secondary|Percentage of Participants With Complete or Major Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as [number of participants with complete or major response divided by the number of participants who completed the assessment] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2764279|NCT00778102|Secondary|Percentage of Participants With Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as [number of participants with a given response divided by the number of participants who completed the assessment] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.|||percentage of participants|||Number
2764280|NCT00778102|Secondary|Time to Resection|Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; and at time of surgery)|ITT Population|||months||95% Confidence Interval|Median
2764281|NCT00778102|Primary|Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor|Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as [number of participants with R0, R1, and/or R2 divided by the total number of participants] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2764282|NCT00777946|Secondary|Percentage of Participants Achieving a Systolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
2764283|NCT00777946|Secondary|Percentage of Participants Achieving a Diastolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
2764284|NCT00777946|Secondary|Percentage of Participants Achieving Blood Pressure Control|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
2764285|NCT00777946|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|"The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.~Additional information about Adverse Events can be found in the Adverse Event Section."|8 weeks|Safety Population consisted of all randomized participants who received study drug.|||participants|||Number
2764286|NCT00777946|Secondary|Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||mm Hg||Standard Error|Least Squares Mean
2764298|NCT00777803|Secondary|Responder by Investigator's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764287|NCT00777946|Primary|Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||mm Hg||Standard Error|Least Squares Mean
2764288|NCT00777855|Secondary|Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin|Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days|||ng/ml||Standard Deviation|Mean
2764289|NCT00777855|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin|Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days|||ng/ml*h||Standard Deviation|Mean
2764290|NCT00777855|Primary|S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.|Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.|0-12 hours after warfarin dosing|Each of 10 participants received both treatments separated by a minimum of 14 days; treatment sequence was randomly assigned|||ng/ml*h||Standard Deviation|Mean
2764291|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.|||participants|||Number
2764292|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.|||participants|||Number
2764293|NCT00777803|Secondary|Response by Patient's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764294|NCT00777803|Secondary|Responder by Patient's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764295|NCT00777803|Secondary|Responder by Patient's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764296|NCT00777803|Secondary|Responder by Patient's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764297|NCT00777803|Secondary|Responder by Investigator's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764416|NCT00776984|Secondary|ACQ Score at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2764299|NCT00777803|Secondary|Responder by Investigator's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764300|NCT00777803|Secondary|Responder by Investigator's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764301|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764302|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764303|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764304|NCT00777803|Primary|Responder by Independent Rater's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
2764305|NCT00777790|Primary|Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.|Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.|Day 0 and 8 and 28 days post-vaccination|GMT results were on the per-protocol population for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
2764306|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
2764307|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
2764308|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)|For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
2764309|NCT00777764|Primary|Number of Participants by of Adverse Events Following a Skin Test Procedure|"Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours.~Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death."|Up to 7 days following skin testing|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient.|||participants|||Number
2764310|NCT00777634|Primary|Incidence of Diagnosis of Three or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
2764311|NCT00777634|Primary|Incidence of Diagnosis of Two or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
2764312|NCT00777634|Primary|Incidence of Diagnosis of Any Metabolic Syndrome Component|The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
2764313|NCT00777634|Primary|Incidence of Diagnosis of Type 2 Diabetes|The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
2764314|NCT00777634|Primary|Incidence of Diagnosis of Hypertension|The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
2764315|NCT00777634|Primary|Incidence of Diagnosis of Dyslipidemia|The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
2764316|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12|"The ADAS-Cog is a psychometric instrument that evaluates memory, attention,~reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline."|Baseline and 4 weeks, 8 weeks and 12 weeks.|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
2764317|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.|Baseline and 2 weeks, 8 weeks and 12 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
2764318|NCT00777608|Primary|Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.|Baseline and 4 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
2764319|NCT00777556|Secondary|Participants Summarized by Repeat Use of Emergency Contraception (EC)|As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.|up to week 8|Participants dispensed the product|||participants|||Number
2764320|NCT00777556|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.|Day 1 to week 8|Safety population of participants who took study drug|||participants|||Number
2764321|NCT00777556|Primary|Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions|The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.|Week 1|Eligible participants who appropriately self-selected and used the product.|||percentage of treated participants||95% Confidence Interval|Number
2770133|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 42||Baseline and week 42|Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2764322|NCT00777556|Primary|Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions|The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.|Day 1|Enrolled participants|||percentage of participants||95% Confidence Interval|Number
2764323|NCT00777491|Secondary|Determining Potentially Predictive Biomarkers for Cystectomy-free Survival||The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from our tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2764324|NCT00777491|Secondary|Determining Potentially Predictive Biomarkers for Acute and Late Toxicities||The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from our tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2764325|NCT00777491|Secondary|Change in American Urological Association Symptom Index (AUASI) Score at 3 Years|The AUASI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as 3-year score - baseline score such that a negative change indicates improvement.|Baseline and 3 years|Eligible patients with baseline and 3-year scores|||units on a scale||Full Range|Median
2764326|NCT00777491|Secondary|Preservation of the Native, Tumor-free Bladder 5 Years After Completion of Study Therapy||Five years from the end of therapy||2020-11-30|11/2020||||
2764327|NCT00777491|Secondary|Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy|Patients will be considered as having a clinical complete response when all biopsies are negative at the site(s) of the pretreatment tumor(s).|3-4 weeks following induction therapy (approximately maximum 8 weeks from start of treatment depending on treatment arm and allowed time windows)|Eligible patients who started induction therapy|||Participants|||Count of Participants
2764328|NCT00777491|Secondary|Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events|Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. All adverse events are counted, regardless of reported relationship to protocol treatment.|From start of treatment to 180 days after the end of treatment. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.|Eligible patients with adverse event data for corresponding time period|||Participants|||Count of Participants
2764329|NCT00777491|Secondary|Percentage of Patients Who Completed Treatment Per Protocol|Treatment administration data was centrally reviewed to determine if patients completed each treatment component per protocol.|After each treatment component (induction, consolidation, adjuvant). Timing varies bases on arm, tumor response at multiple time points, and allowed time ranges.|Eligible patients who started each treatment component (induction, consolidation, adjuvant)|||Participants|||Count of Participants
2764330|NCT00777491|Primary|Percentage of Patients Without Distant Metastases by Three Years|Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone.|From randomization to three years|Eligible patients with 3-year data|||percentage of participants||90% Confidence Interval|Number
2764331|NCT00777335|Secondary|Corrected QT Interval Fridericia's Formula (QTcF)|Prolonged QTcF: QTcF >450 msec and increase of baseline on greater than or equal to 60 msec.|Panobinostat intra-venous (i.v.): All cycles pre-dose measurements. For cycles 1 and 2, post-dose measurements as well. / Panobinostat oral: Pre-dose and post-dose measurements for all cycles. Note: each cycle = 3 weeks||||participants|||Number
2764332|NCT00777335|Primary|Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR).|"The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan)~CR:Disappearance of all target lesions~PR:>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD~Progressive Disease (PD):>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions~Stable Disease(SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the nadir SLD"|At screening, every 2 cycles (i.e. 6 weeks) during the first 6 cycles, every 3 cycles (i.e. 9 weeks) during the subsequent cycles and at the End of Treatment (EOT) visit. After the EOT, the tumor assessments should be performed every 9 weeks.||||participants|||Number
2764417|NCT00776984|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Score on a scale||Standard Error|Mean
2764333|NCT00777296|Secondary|CFQ-R Respiratory Scale (Absolute Change From Baseline).|Quality of Life was measured by the absolute change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory scale. Disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms in patients with a diagnosis of cystic fibrosis. Scores range from 0 to 100, with higher scores indicating better health. Scores for each Health Related Quality of Life (HRQoL) domain; after recoding, each item is summed to generate a domain score and standardized.|Baseline/Day 1, Day 15, Day 28 and Day 42|The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.|||score on a scale||Standard Deviation|Mean
2764334|NCT00777296|Secondary|Number of Subjects Requiring Antipseudomonal Rescue Therapy.|Number of Subjects requiring systemic antipseudomonal rescue therapy during the study in both the ARIKACE™ and placebo groups.|Through study duration, approximately 56 days|The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.|||Participants|||Count of Participants
2764335|NCT00777296|Secondary|Duration of Systemic Antipseudomonal Rescue Therapy.|Duration of systemic antipseudomonal rescue therapy during the study in both the ARIKACE™ and placebo groups.|Through study duration, approximately 56 days|The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.|||days||Standard Deviation|Mean
2764336|NCT00777296|Secondary|Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.|End-of-treatment (Day 28) from baseline in density of P. aeruginosa (log10 CFU/g) in sputum.|Day 7, Day 14, Day 21, Day 28 and Day 35|The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.|||log10CFU per gram||Standard Deviation|Mean
2764337|NCT00777296|Secondary|Pulmonary Function: FEV1.|Mean Percent Change (%) from Baseline to End of treatment (Day 28) and Day 56 in Pulmonary Function.|Baseline, Day 28, and Day 56|"The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.~Placebo is a pooled value from cohort 280 mg and cohort 560 mg."|||Mean Percent (%) Change in FEV1||Standard Deviation|Mean
2764338|NCT00777296|Secondary|Pulmonary Function: FEV1 %-Predicted.|Relative Change (%) from Baseline to End of treatment (Day 28) and Day 56 in Pulmonary Function.|Baseline, Day 28, and Day 56|"The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.~Placebo is a pooled value from cohort 280 mg and cohort 560 mg."|||Relative Percent (%) change in FEV1||Standard Deviation|Mean
2764339|NCT00777296|Secondary|Sputum Amikacin Levels of Arikace™.|Measure PK parameter (sputum amicakin concentration) of Arikace™ in sputum.|Day 1, Day 14 and Day 28|The PK population consisted of subjects who received amikacin, had at least one serum PK assessment and were not replaced.|||mcg/g||Standard Deviation|Mean
2764340|NCT00777296|Secondary|Pharmacokinetics (PK) of Arikace™ in Urine.|Measure PK parameter (Ae0-24 (mg) of Arikace™.|Day 1, Day 14 and Day 28|The PK population consisted of subjects who received amikacin, had at least one serum PK assessment and were not replaced.|||mg||Standard Deviation|Mean
2764341|NCT00777296|Secondary|Pharmacokinetics (PK) of Arikace™ in Sputum (AUC).|Measure PK parameter (AUC0-24) of Arikace™ in sputum.|28 days|The PK population consisted of subjects who received amikacin, had at least one serum PK assessment and were not replaced.|||mcg*hr/g||Standard Deviation|Mean
2764342|NCT00777296|Secondary|Pharmacokinetic (PK) of Arikace in Serum (Cmax).|Measure PK parameter (Cmax) of Arikace™ in serum.|Day 1, Day 14 and Day 28|The PK population consisted of subjects who received amikacin, had at least one serum PK assessment and were not replaced.|||mg/L||Standard Deviation|Mean
2764343|NCT00777296|Secondary|Pharmacokinetics (PK) of Arikace™ in Serum.|Measure PK parameters (AUC0-infinity) of Arikace™ in serum.|Day 1, Day 14 and Day 28|The PK population consisted of subjects who received amikacin, had at least one serum PK assessment and were not replaced.|||mg.hr/L||Standard Deviation|Mean
2764344|NCT00777296|Primary|Clinically Significant Laboratory Abnormalities.|Changes in chemistry and hematology lab tests (clinically significant value of CTCAE grade ≥ 3).|28 Days|The analysis population is the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug.|||Participants|||Count of Participants
2764345|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 Post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
2764346|NCT00777257|Secondary|Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.|Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.|0 to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population|||Percentage of participants|||Number
2764347|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
2764348|NCT00777257|Primary|Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.||Day 0 to Day 28 post-vaccination|Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population|||Percentage of participants|||Number
2764362|NCT00777153|Secondary|Response Rate|"An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.~An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan."|Baseline at 6 weeks and then every 6 weeks to discontinuation|Patients are only included in the analysis if they have measurable disease at baseline based on central.|||Participants|||Number
2764349|NCT00777205|Primary|Recovery Orientation|The 30-item Mental Health Recovery Measure (MHRM) was used to assess recovery orientation. The MHRM has been fielded among diverse populations and has a high level of internal consistency (Cronbach's α =.93) and shows change following engagement in recovery oriented treatments. The MHRM is scored using a 5 point Likert Scale (0 to 4) for each item, yielding a theoretical range from 0 - 120 for Total Score. Higher scores correspond to a higher self-reported level of mental health recovery.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
2764350|NCT00777205|Primary|Depression Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
2764351|NCT00777205|Primary|Quality of Life|The 14-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), which has good reliability and has been used in multiple depression studies, was used to assess quality of life. Responses are scored on a 5-point scale ('not at all or never' to 'frequently or all the time'), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70).|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
2764352|NCT00777205|Primary|Change in Functional Status-Physical Health (PCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
2764353|NCT00777205|Primary|Change in Functional Status-Mental Health (MCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
2764354|NCT00777179|Secondary|Objective Response Rate (ORR)|"Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response."|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||Participants|||Number
2764355|NCT00777179|Secondary|Disease of Response (DOR)|"Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response"|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||Participants|||Number
2764356|NCT00777179|Secondary|Overall Survival (OS)|Overall survival (OS) defined as the median time from randomization to death from any cause.|Every 12 weeks unless the patient withdraws consent||||months||95% Confidence Interval|Median
2764357|NCT00777179|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||months||95% Confidence Interval|Median
2764358|NCT00777179|Primary|Progression-free Survival (PFS) Rate at 3 Months|Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.|12 weeks|The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.|||Participants|||Number
2764359|NCT00777153|Secondary|Steroid Free Days|Number of days known not to have used any steroids prior to progression|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25||||Days||Standard Deviation|Mean
2764360|NCT00777153|Secondary|Daily Steroid Dose|The mean steroid dosage prior to treatment will be considered as the patient's baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25||||percentage of change|||Number
2764361|NCT00777153|Secondary|Alive and Progression Free Rate at 6 Months (APF6)|Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.|6 Months||||% of patients alive and progression free|||Number
2764363|NCT00777153|Secondary|Overall Survival (OS)|Number of months from randomisation to the date of death from any cause|Baseline through to date of death up to 25th April 2010||||Months||Inter-Quartile Range|Median
2764364|NCT00777153|Primary|Progression Free Survival (PFS)|"For patients with measurable disease at entry (at least one lesion that has a shortest diameter~≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:~The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.~The patient has died from any cause.~A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm."|Baseline at 6 weeks and then every 6 weeks to discontinuation||||Days||Inter-Quartile Range|Median
2764365|NCT00777101|Secondary|Time to CNS Metastases|Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).|From randomization date to first CNS symptom or lesions|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
2764366|NCT00777101|Secondary|Frequency of CNS Metastases (Frequency)|The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.|From randomization date to first CNS symptom or lesions|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants|||Number
2764367|NCT00777101|Secondary|Duration of Response|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From start date of response to first PD, assessed up to 69 months after the first subject was randomized.|No. of Subjects with either complete or partial response.|||months||95% Confidence Interval|Median
2764368|NCT00777101|Secondary|Clinical Benefit Rate|"Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~Clinical Benefit (CB) = CR + PR + SD >= 24 weeks."|From randomization date to progression or last tumor assessment, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants||95% Confidence Interval|Median
2764369|NCT00777101|Secondary|Objective Response Rate (ORR).|Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From randomization date to progression or last tumor assessment, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants||95% Confidence Interval|Number
2764370|NCT00777101|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.|From randomization date to death, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
2764371|NCT00777101|Primary|Progression Free Survival|Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.|From randomization date to progression or death, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
2764372|NCT00777088|Secondary|Number of Participants With Device-related Adverse Events at 5 Years|Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement|5 years|Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement|||Participants|||Count of Participants
2764373|NCT00777088|Secondary|Number of Participants With Device-Related Adverse Events at 3 Years|Number of participants with incidence of device-related adverse events at 3 year follow-up|3 years||||Participants|||Count of Participants
2764374|NCT00777088|Secondary|Stenosis of the Parent Artery in PED at 5 Years|Parent artery stenosis at 5-year follow-up|5-years|Subjects that completed imaging at the 5-year follow-up were included in the parent artery stenosis analysis.|||Parent Artery Assessments|Parent Artery Assessments||Count of Units
2764375|NCT00777088|Secondary|Stenosis of the Parent Artery in PED at 3 Years|Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up|3-years|Subjects that completed imaging at the 3-year follow-up were included in the parent artery stenosis analysis.|||Parent Artery Assessments|Parent Artery Assessments||Count of Units
2764376|NCT00777088|Secondary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years|"The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|5 years|Pipeline treated subjects with observable data at 5 years|||Target Intracranial Aneurysms|Target Intracranial Aneurysms||Count of Units
2764377|NCT00777088|Secondary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up|"The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|3 years|Pipeline treated Subjects with observable data at 3 years|||Target Intracranial Aneurysms|Target Intracranial Aneurysms||Count of Units
2764378|NCT00777088|Secondary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year|"The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|1 Year|Pipeline treated subjects with observable data at 1 year|||Target Intracranial Aneurysms|Target Intracranial Aneurysms||Count of Units
2764379|NCT00777088|Primary|Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.|"The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows:~Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac"|180 days|A total of 104 participants and 106 intracranial aneurysms treated with the Pipeline Embolization Device were included in the primary effectiveness endpoint analysis.|||Fully Occluded Intracranial Aneurysms|Fully Occluded Intracranial Aneurysms||Count of Units
2764380|NCT00777088|Primary|Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.|The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.|180-days and 5-years|Patients treated with one or more Pipeline Embolization Devices.|||Participants|||Count of Participants
2764381|NCT00777062|Primary|Time Line Follow Back -Reported Days of Abstinence From Drinking|Percentage of participants who were abstinent from drinking|8 week medication phase||||Percentage of Participants|||Number
2764382|NCT00777062|Primary|Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.|Percentage of subjects with no cocaine use for at least 3 weeks|8 week medication phase||||Percentage of Participants|||Number
2764383|NCT00777049|Primary|Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.|The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).|6 years and 2 months||||participants|||Number
2764384|NCT00777036|Secondary|Complete Molecular Response (CMR) Rate up to 2 Years|Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.|24 months|All randomized treated participants|||percentage||95% Confidence Interval|Number
2764385|NCT00777036|Secondary|Major Molecular Response (MMR) Rate up to 2 Years|Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
2764386|NCT00777036|Secondary|Complete Cytogenetic Response (CCyR) Rate up to 2 Years|Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
2764387|NCT00777036|Secondary|Major Cytogenetic Response (MCyR) Rate up to 2 Years|Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
2764388|NCT00777036|Secondary|Complete Molecular Response (CMR) Rate|Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.|From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)|All treated participants|||percentage||95% Confidence Interval|Number
2764401|NCT00777036|Secondary|Major Cytogenetic Response (MCyR) Rate in Cohort 2|Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 2|||percent of participants||95% Confidence Interval|Number
2764389|NCT00777036|Secondary|Major Molecular Response (MMR) Rate|Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.|From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
2764390|NCT00777036|Secondary|Overall Survival (OS) Rate at 2 Years|OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.|2 years|All randomized and treated participants|||percentage||95% Confidence Interval|Number
2764391|NCT00777036|Secondary|Disease-Free Survival Rate at 2 Years|Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation.|2 years|All randomized treated participants with response of CCyR or CHR|||percentage||95% Confidence Interval|Number
2764392|NCT00777036|Secondary|Duration of Complete Hematologic Response (CHR)|Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.|From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)|All treated participants with CCyR|||months||95% Confidence Interval|Median
2764393|NCT00777036|Secondary|Time to Complete Hematologic Response (CHR)|Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.|From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)|All treated participants with CHR|||months||95% Confidence Interval|Median
2764394|NCT00777036|Secondary|Progression-Free Survival (PFS) Rate at 2 Years|"PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation.~Disease Progression was defined as any of the following criteria:~For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose~Increasing WBC~Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood)~Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir~Death from any case during treatment"|2 years|All treated participants|||percentage||95% Confidence Interval|Number
2764395|NCT00777036|Secondary|Duration of Complete Cytogenetic Response (CCyR)|Duration of CCyR will be computed from the first day criteria are met for CCyR until the date PD is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last.|From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)|All treated participants who achieved CCyR|||months||95% Confidence Interval|Median
2764396|NCT00777036|Secondary|Time to Complete Cytogenetic Response (CCyR)|Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR.|From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)|All treated participants with CCyR|||months||95% Confidence Interval|Median
2764397|NCT00777036|Secondary|Duration of Major Cytogenetic Response (MCyR)|Duration of MCyR will be computed from the first day criteria are met for MCyR until the date PD is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last.|From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)|All treated participants with MCyR|||months||95% Confidence Interval|Median
2764398|NCT00777036|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR.|From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)|All treated participants with MCyR|||months||95% Confidence Interval|Median
2764399|NCT00777036|Secondary|Rate of Best Cytogenetic Response|The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|All treated participants|||percentage of participants|||Number
2764400|NCT00777036|Secondary|Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3|Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohorts 1 and 3|||percentage of participants||95% Confidence Interval|Number
2764402|NCT00777036|Primary|Complete Cytogenetic Response (CCyR) Rate|Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 3|||percentage of participants||95% Confidence Interval|Number
2764403|NCT00777036|Primary|Complete Hematologic Response (CHR) Rate|Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 2|||percentage of participants||95% Confidence Interval|Number
2764404|NCT00777036|Primary|Major Cytogenetic Response (MCyR) Rate|Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 1|||percentage of participants||95% Confidence Interval|Number
2764405|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 12 weeks of treatment|Intent to treat population|||Units on a scale||95% Confidence Interval|Least Squares Mean
2764406|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 4 weeks of treatment|Intent to treat population|||Units on a scale||95% Confidence Interval|Least Squares Mean
2764407|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 12 weeks of treatment|Intent to treat population|||Hot flashes||95% Confidence Interval|Least Squares Mean
2764408|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 4 weeks of treatment|Intention to treat population|||Hot flashes||95% Confidence Interval|Least Squares Mean
2764409|NCT00776997|Secondary|Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline||12 months||||participants|||Number
2764410|NCT00776997|Secondary|At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline||12 months||||participants|||Number
2764411|NCT00776997|Primary|Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.|The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.|12 Months||||participants|||Number
2764412|NCT00776997|Primary|Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).|"SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:~Results in death~Is life-threatening~Requires subject hospitalization > 24 hours~Requires prolongation of an existing hospitalization~Results in persistent or significant disability/incapacity~Results in fetal distress, fetal death, or a congenital anomaly or birth defect~Requires intervention to prevent permanent impairment or damage.~Outcome measure reports number of subjects with reported events."|through 24 months||||participants|||Number
2764413|NCT00776984|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)|||percentage of participants|||Number
2764414|NCT00776984|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Puffs||Standard Error|Mean
2764418|NCT00776984|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2764419|NCT00776984|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2764420|NCT00776984|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
2764421|NCT00776984|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
2764422|NCT00776984|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As < 50 percent (10 of 232 patients in the placebo group and 8 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
2764423|NCT00776984|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
2764424|NCT00776984|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
2764425|NCT00776984|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
2764426|NCT00776984|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
2764427|NCT00776984|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As < 50 percent (81 of 232 patients in the placebo group and 69 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
2764428|NCT00776984|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Percent||Standard Error|Mean
2764429|NCT00776984|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
2764430|NCT00776984|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
2764481|NCT00776230|Primary|Primary: 1. Geometric Mean Titers (GMT) at Day 56||56 days post 1st vaccination|Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication|||Geometric Mean Titer - Estimate||95% Confidence Interval|Geometric Mean
2764431|NCT00776984|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
2764432|NCT00776984|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
2764433|NCT00776984|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764434|NCT00776984|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764435|NCT00776984|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764436|NCT00776984|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764437|NCT00776984|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764438|NCT00776984|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764439|NCT00776984|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764440|NCT00776984|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764441|NCT00776984|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764442|NCT00776984|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764443|NCT00776984|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||Days||Inter-Quartile Range|Median
2764444|NCT00776984|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2764445|NCT00776984|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.|||Liter||Standard Error|Mean
2764446|NCT00776919|Secondary|Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation|An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.|Baseline (Day 1) through Week 12|ITT Population|||participants|||Number
2764447|NCT00776919|Secondary|Mean Duration of Study Product Use|Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.|Baseline (Day 1) through Week 12|ITT Population|||days||Standard Deviation|Mean
2764448|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging|Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.|||scores on a scale||Standard Deviation|Mean
2764449|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling|Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.|||scores on a scale||Standard Deviation|Mean
2764450|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Pulse Rate|Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
2764451|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Temperature|Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Degrees centigrade||Standard Deviation|Mean
2764452|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2764453|NCT00776919|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score >=2.|||participants|||Number
2764454|NCT00776919|Secondary|Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12|During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score >=2.|||participants|||Number
2764483|NCT00776100|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
2764455|NCT00776919|Secondary|Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||Percent change in lesion counts||Standard Deviation|Mean
2764456|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Total Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||lesion counts||Standard Deviation|Mean
2764457|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||lesion counts||Standard Deviation|Mean
2764458|NCT00776919|Primary|Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.|||lesion counts||Standard Deviation|Mean
2764459|NCT00776919|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Baseline (Day 1) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.|||participants|||Number
2764460|NCT00776789|Secondary|Breast Feeding Status at 6 Weeks|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases|6 weeks||||percentage of partcipants|||Number
2764461|NCT00776789|Secondary|Breast Feeding Status at 48 Hours|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.|48 hours|EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.|||percentage of partcipants|||Number
2764462|NCT00776789|Secondary|Salivary Cortisol|Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).|6 hours||||microgram/dl||Inter-Quartile Range|Median
2764482|NCT00776100|Secondary|Duration of Response|Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
2764463|NCT00776789|Primary|The Median Breast Feeding Score|This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure [0 to 3] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more >=8.|36-48 hours by video recording||||scores||Inter-Quartile Range|Median
2764464|NCT00776659|Primary|Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.||||||
2764465|NCT00776659|Primary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.||||||
2764466|NCT00776659|Primary|Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.|Baseline up to 28 days after last dose of study treatment|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
2764467|NCT00776659|Primary|Number of Participants Who Discontinued Aromasin Therapy||Baseline until discontinuation (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
2764468|NCT00776659|Primary|Number of Participants Who Died||Baseline until death (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
2764469|NCT00776659|Primary|Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer||Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2764470|NCT00776659|Primary|Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer|Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.|Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2764471|NCT00776594|Secondary|Analysis of Cytokines and Angiogenic Factors in Plasma/Serum|Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).|6 months||||pg/ml||Inter-Quartile Range|Median
2764472|NCT00776594|Secondary|Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).|The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.|6 months||||participants|||Number
2764473|NCT00776594|Secondary|Number of Participants With PSA <0.2 ng/ml at Six Months|Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).|Six months (at completion of treatment)||||Number of participants|||Number
2764474|NCT00776594|Primary|Relapse-free Survival|To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.|2 years||||months||95% Confidence Interval|Median
2764475|NCT00776555|Secondary|DRQ-S, Question 3|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
2764476|NCT00776555|Secondary|DRQ-S, Question 1|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
2764477|NCT00776555|Primary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
2764478|NCT00776295|Secondary|3 Year Progression-free Survival|3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC|up to 3 years||||participants|||Number
2764479|NCT00776295|Primary|Number of Subjects Meeting 1-year Overall Survival|Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death|up to one year||||participants|||Number
2764480|NCT00776230|Secondary|Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability||see above|||||||
2770134|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 30||Baseline and week 30|Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2764484|NCT00776100|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to disease progression (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
2764485|NCT00776100|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.|Time from registration to disease progression or death (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
2764486|NCT00776100|Secondary|Response Rate|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
2764487|NCT00776100|Primary|Overall Survival|Overall survival was defined as the time from registration to the date of death or last follow-up|Time from registration to death or last follow-up (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
2764488|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose|"Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement."|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement.|||Number correct||Standard Error|Least Squares Mean
2764489|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose|"Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement."|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Number attempted||Standard Error|Least Squares Mean
2764490|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
2764491|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
2764492|NCT00776009|Primary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
2764513|NCT00775671|Secondary|Measurement of Insulin Sensitivity|The change in insulin sensitivity index, from baseline to after 12 weeks of treatment. Calculated from the intravenous glucose tolerance test at baseline and at 12 weeks.|3 hours||||10-4xmin-1 per mU/L||Standard Deviation|Mean
2764493|NCT00775983|Secondary|Participants Who Experienced Complications or Need for Additional Dilation|Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.|||participants|||Number
2764494|NCT00775983|Primary|Procedure Time|Procedure time to complete early second-trimester dilation and evacuation (D&E)|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.|||minutes||Standard Error|Mean
2764495|NCT00775944|Secondary|Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)|Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.|Measured 6 months after participant's quit date|||||||
2764496|NCT00775944|Secondary|Health Status at 6 Months EuroQol 5D (EQ5D)|This is a generic measure of health status used in health economic analyses.|Measured 6 months after participant's quit date|||||||
2764497|NCT00775944|Secondary|Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months|As title|Measured 6 months after participant's quit date|||||||
2764498|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month|Participants had to report not smoking for 7 or more days prior to outcome ascertainment.|Measured at 1 month after participant's quit date|All randomised cases|||participants|||Number
2764499|NCT00775944|Secondary|Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month|Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.|Measured at 1 month after participant's quit date|All randomised cases|||participants|||Number
2764500|NCT00775944|Secondary|Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months|Participants had to report not smoking in the three months prior to outcome ascertainment.|Measured at 6 months after participant's quit date|All randomised cases|||participants|||Number
2764501|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.|The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.|Measured 6 months after participant's quit date||||participants|||Number
2764502|NCT00775944|Primary|Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.|Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.|6 months from participant's quit date|All randomised cases|||participants|||Number
2764503|NCT00775931|Secondary|Incidence of Grade II - IV Acute Graft-versus-host Disease||by Day 100 after transplant||||Participants|||Count of Participants
2764504|NCT00775931|Secondary|Transplant Related Toxicity||Day 100 post transplant||||Participants|||Count of Participants
2764505|NCT00775931|Secondary|Transplant Related Mortality at 100 Days||day 100||||Participants|||Count of Participants
2764506|NCT00775931|Primary|Number of Patients Who Achieved Donor Cell Engraftment||Day 100||||Participants|||Count of Participants
2764507|NCT00775684|Primary|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)|AGRmin is performed during the 340mg/dl glucose clamp allows for estimation of the minimum alpha-cell glucagon secretion. Changes from baseline to 6 months of AGRmin were compared across groups.|Baseline and 6 months|"We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months."|||pg/mL||Standard Error|Mean
2764508|NCT00775684|Secondary|PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months|Between ∼60 and 250 mg/dL, the magnitude of AIRarg is a linear function of the plasma glucose level, so the difference in AIRarg at fasting and 230 mg/dL glucose levels divided by the difference in plasma glucose (ΔAIRarg/ΔPG) gives the glucose-potentiation slope (GPS) (8,24-26). Using the y-intercept (b) from the line created by these two points, the plasma glucose level at which half-maximal insulin secretion is achieved (PG50) is derived from solving the equation 1/2 (AIRmax) = (GPS · PG50) + b, and provides a measure of β-cell sensitivity to glucose The mean difference after 6 months in PG 50 were compared. Listed below are the PG50 values at baseline and 6 months.|Baseline and 6 months||||mg/dL||Standard Error|Mean
2764509|NCT00775684|Secondary|Insulin Sensitivity at Baseline and 6 Months|Insulin sensitivity (M/I) was determined by dividing the mean glucose infusion rate required during the 230 mg/dL glucose clamp (M) by the mean prestimulus insulin level (I) between 40 and 45 min of the glucose infusion The mean difference after 6 months in insulin sensitivity (M/I) were compared|Baseline and 6 months||||((mg/kg) /min) /uU/mL||Standard Error|Mean
2764510|NCT00775684|Secondary|Change in Acute Insulin Response to Arginine. (AIRarg)|The changes in B-cell insulin secretion, Acute Insulin Response to arginine (AIRarg) after 6 months were compared to baseline AIRarg for each group. Listed below are AIRarg at baseline and 6 months for each group.|Baseline and 6 months||||uU/mL||Standard Error|Mean
2764511|NCT00775684|Primary|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)|The acute insulin response to arginine (AIRarg) performed during the 340mg/dl glucose clamp allows for estimation of the the beta-cell secretory capacity (AIRmax) or functional beta-cell mass. Changes from baseline to 6 months of AIRmax were compared across groups|Baseline and 6 months|"We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months."|||μU/ml||Standard Error|Mean
2764512|NCT00775671|Primary|Marker of Fibrinolysis|Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.|After 12 weeks of study drug||||ng/mL||Standard Deviation|Mean
2764517|NCT00775645|Other Pre-specified|Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status|Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
2764518|NCT00775645|Other Pre-specified|Treatment and Concurrent Therapy|total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
2764519|NCT00775645|Other Pre-specified|Serum Nerve Growth Factor Levels||12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
2764520|NCT00775645|Other Pre-specified|Proportion of Patients Experiencing Grade 3 or 4 Neuropathy|Proportion of patients experiencing grade 3 or 4 neuropathy|12 weeks post-registration||||Participants|||Count of Participants
2764521|NCT00775645|Secondary|12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups|Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||FACIT-fatigue score||Full Range|Mean
2764522|NCT00775645|Secondary|12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups|Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||units on a scale||Full Range|Mean
2764523|NCT00775645|Primary|12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups|Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||units on a scale||Full Range|Mean
2764524|NCT00775606|Secondary|Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines|Response to immunization with pneumococcus polysaccharide and tetanus-diphtheria vaccines was not done due to small sample size|4 weeks after treatment initiation|||||||
2764525|NCT00775606|Secondary|Activated and Regulatory CD4+ and CD8+ T-cell Frequencies||4, 12 and 24 weeks after treatment initiation|||||||
2764526|NCT00775606|Secondary|Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency||4, 12 and 24 weeks after treatment initiation|||||||
2764527|NCT00775606|Secondary|CD4+ T-cell Change|This measures the change in CD4+ T-cells from baseline to week 24 of treatment.|24 weeks after treatment initiation (baseline and week 24)||||cells/mm3||Standard Deviation|Mean
2764528|NCT00775606|Primary|CD4+ (Cluster of Differentiation 4) T-cell Apoptosis|Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.|24 weeks from treatment initiation (baseline and week 24)||||per cent||Standard Deviation|Mean
2764529|NCT00775593|Secondary|Duration of Survival||At 2 years from study entry||||months||Full Range|Median
2764530|NCT00775593|Secondary|Duration of Response|Participants who responded to treatment|At 2 years from study entry||||months||Standard Deviation|Mean
2764531|NCT00775593|Secondary|Number of Serious Adverse Events Within 2 Years||At 2 years from study entry||||serious adverse events|||Number
2764532|NCT00775593|Primary|Complete Response Rate||At 2 years from study entry||||participants|||Number
2764533|NCT00775528|Primary|Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)|Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.|10 Days||||Participants|||Number
2764534|NCT00775528|Secondary|Total Calorie Intake (kcal)|The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Kcal||Standard Deviation|Mean
2764535|NCT00775528|Secondary|Fat Intake (g)|The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Grams||Standard Deviation|Mean
2764536|NCT00775528|Secondary|Stool Fat (% Fat)|The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Percentage of fat||Standard Deviation|Mean
2764537|NCT00775463|Secondary|Time to Ulcer Healing|"A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as healed and no new ulcers appeared for the remainder of the trial. The time to complete healing of all ulcers were calculated as the number of days from randomization to the date of these respective assessments, provided that complete healing was achieved during the study."|Week 20||||days||Standard Deviation|Mean
2764538|NCT00775463|Secondary|Time to Ulcer Healing- Percentage of Subjects With Complete Healing|"A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as healed and no new ulcers appeared for the remainder of the trial."|Week 20||||percentage of participants|||Number
2764539|NCT00775463|Secondary|Short Form 36|Change in patient quality of life was measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), a self-administered questionnaire covering eight areas: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. For each area, the score range from 0 (poorer health status) to 100 (better health status). The SF-36 is one of the most widely used and validated instruments to assess quality of life in patients with systemic illnesses. A decrease (negative change) in a domain score corresponds to deterioration.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764540|NCT00775463|Secondary|Patient Impression of Change (PIC) Questionnaire|The PIC questionnaire consisted of three Likert items that asked the subject to rate changes in their digital ulcer, Raynaud's phenomenon and disease status since their last visit on a seven-level scale (very much improved, much improved, somewhat improved, same, somewhat worse, much worse and very much worse).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||participants|||Number
2764541|NCT00775463|Secondary|Short-Form McGill Pain Questionnaire|The SF-MPQ assessment has three component scores: the pain rating index (PRI), a pain visual analogue numerical scale (Pain VAS) and the present pain intensity (PPI). PRI is calculated by summing the responses (0=None to 3=Severe) to the 15 questions describing pain during the previous week and rated on an intensity scale as 0= none, 1= mild, 2= moderate or 3= severe and has possible values ranging from 0 to 45. The Pain VAS is a 100 mm VAS on which subjects were asked to rate pain during the previous week with values ranging from no pain (0.0) to worst possible pain (10.0). The PPI rated pain on a 6-point category scale from 0 (no pain) to 5 (excruciating pain).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764542|NCT00775463|Secondary|Modified Rodnan Skin Score (mRSS)|The skin thickening was assessed by the Investigator in 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each area was scored 0-3; 0 representing normal skin and 3 being severe thickening. The mRSS was the sum of the individual skin assessment scores: possible range of 0-51; 0 (no thickening) to 51 (severe thickening in all 17 areas) .|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764543|NCT00775463|Secondary|Scleroderma Health Assessment Questionnaire (SHAQ)|The SHAQ is a patient self-administered instrument which has been previously validated in SSc and demonstrates meaningful clinical changes in the course of the disease over time. It is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud's Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite HAQ DI score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764544|NCT00775463|Secondary|Cochin Hand Function Scale (CHFS)|The CHFS has been demonstrated as a reliable and valid assessment of hand function at the activity level in persons with SSc. It is comprised of 18 questions with possible integer responses of 0 (without difficulty) to 5 (impossible). The CHFS Score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS Score values can range from 0 (least limitation) to 90 (most limitation). A higher score indicates more difficulty in hand function or greater disability.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||95% Confidence Interval|Median
2764545|NCT00775463|Secondary|Physician Global Assessment of Digital Ulcer Severity VAS|"Physicians rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term severity was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764546|NCT00775463|Secondary|Patient Global Assessment of Digital Ulcer Severity VAS|"Patients rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term severity was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764547|NCT00775463|Secondary|Digital Ulcer Pain VAS|Digital ulcer pain was rated on a 100-mm VAS on which subjects were asked to rate their average overall hand pain during the last week. The recorded value was divided by 10, with values ranging from 0.0 (no pain) to 10.0 (unbearable pain), expressed to one decimal.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
2764548|NCT00775463|Primary|Net Ulcer Burden|"Net ulcer burden was defined as the number of new or active digital ulcers (DU), plus the number of indeterminate DUs at that assessment that have previously been classified as either active or new at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced active. If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as active. Otherwise, the DU was pronounced indeterminate. Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change.|||ulcers||Inter-Quartile Range|Median
2764549|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
2764550|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.|Days 0 and 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
2764551|NCT00775450|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2764552|NCT00775450|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.|Days 0 through 7 post vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
2764553|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764554|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764555|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2770135|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 18||Baseline and week 18|Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2764556|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764557|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764558|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764559|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764560|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764561|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764562|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764563|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764564|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2770136|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 6||Baseline and week 6|Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
2764565|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764566|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.||||units on a scale||Standard Deviation|Mean
2764567|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764568|NCT00775437|Secondary|Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit|"Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764569|NCT00775437|Secondary|Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit|"Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764570|NCT00775437|Secondary|Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit|"Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764571|NCT00775437|Secondary|C-reactive Protein (CRP): Mean Change From Baseline to Each Visit|CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||mg/dL||Standard Deviation|Mean
2764572|NCT00775437|Secondary|Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit|"Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764573|NCT00775437|Secondary|Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit|A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764641|NCT00775021|Secondary|Initial Comfort|Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 Week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2764574|NCT00775437|Secondary|Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit|The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764575|NCT00775437|Secondary|Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The parent's assessment of how the participant's arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764576|NCT00775437|Secondary|Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The physician's assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
2764577|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)|The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
2764578|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)|The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
2764579|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)|The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
2764580|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)|The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
2764581|NCT00775437|Secondary|Uric Acid: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
2764582|NCT00775437|Secondary|Creatinine: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
2764583|NCT00775437|Secondary|Total Bilirubin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
2764584|NCT00775437|Secondary|Creatine Phosphokinase: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
2764585|NCT00775437|Secondary|Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
2764586|NCT00775437|Secondary|Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
2764587|NCT00775437|Secondary|Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
2764588|NCT00775437|Secondary|Basophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
2764589|NCT00775437|Secondary|Eosinophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
2764590|NCT00775437|Secondary|Monocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
2764591|NCT00775437|Secondary|Lymphocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
2764592|NCT00775437|Secondary|Neutrophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
2764593|NCT00775437|Secondary|White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
2764594|NCT00775437|Secondary|Platelets: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
2764595|NCT00775437|Secondary|Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄12/L||Standard Deviation|Mean
2764596|NCT00775437|Secondary|Hematocrit: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||Fraction||Standard Deviation|Mean
2764597|NCT00775437|Secondary|Hemoglobin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||g/L||Standard Deviation|Mean
2764598|NCT00775437|Secondary|Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24|Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.|Weeks 0, 12, and 24|All participants who had samples for pharmacokinetic analysis|||µg/mL||Standard Deviation|Mean
2764638|NCT00775138|Primary|Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation|Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 3) in Arikayce™ and placebo groups.|Day 1 through 56.|The safety population is the mITT population.|||Participants|||Count of Participants
2770839|NCT00732940|Secondary|Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
2764599|NCT00775437|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).|TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).||||participants|||Number
2764600|NCT00775411|Secondary|Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).|Baseline, Week 26|Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.|||Percentage of participants|||Number
2764601|NCT00775411|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 26|Intent to treat population consisting of all enrolled participants.|||Number of letters||Standard Deviation|Mean
2764602|NCT00775411|Primary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.|Baseline, Week 4|Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.|||Microns||Standard Deviation|Mean
2764603|NCT00775346|Primary|Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).|Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).|9 Hours||||Ratio||90% Confidence Interval|Mean
2764604|NCT00775229|Secondary|Liver Function Tests|Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).|Week 8 (last visit)||||percentage of individuals with LFT chang|||Number
2764605|NCT00775229|Secondary|Massachusetts General Hospital Hairpulling Scale|Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).||||units on a scale||Standard Deviation|Mean
2764606|NCT00775229|Primary|National Institute of Mental Health Trichotillomania Symptom Severity Scale|Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).||||units on a scale||Standard Deviation|Mean
2764607|NCT00775203|Secondary|Discontinuation Due to Lack of Efficacy|Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).|Baseline to Week 8|Safety population is defined as all randomized patients who received any study medication.|||participants|||Number
2764608|NCT00775203|Secondary|Awakening During the Night at Each Visit|"Awakening during the night was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit did you awaken during the night?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2764609|NCT00775203|Secondary|Trouble Falling Asleep at Each Visit|"Trouble Falling Asleep was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit, how often did you experience trouble falling asleep?."|Weeks 1, 2, 3, 4, 6, 8|Full Analysis set (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2764610|NCT00775203|Secondary|Overall Quality of Sleep at Each Visit|"Overall Quality of Sleep was measured on a 4-point rating scale ranging from 1 = very poor to 4 = excellent in response to the question: Since the last study visit, how would you rate the overall quality of your sleep?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Points on a scale||Standard Deviation|Mean
2764611|NCT00775203|Secondary|Patient Global Impression - Improvement of Illness (PGI-I) Responders at Last Study Visit|"Patients were responders if the PGI-I rating was Much Improved or Very Much Improved. The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: Since the start of the study, my overall status with regard to depression is? which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients."|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Responders Week 8 Observed Cases: Trazodone = 176, placebo = 183.|||participants|||Number
2764612|NCT00775203|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I) Responders at Last Study Visit|"Patients were responders if the CGI-I rating was Much Improved or Very Much Improved. The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients."|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Responders Week 8 Observed Cases: Trazodone = 180, placebo = 183.|||participants|||Number
2764613|NCT00775203|Secondary|Patient Global Impression - Improvement of Illness (PGI-I) Score at Last Study Visit|"The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: Since the start of the study, my overall status with regard to depression is? which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse."|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Week 8 Observed Cases: Trazodone = 176, placebo = 183.|||Units on PGI-I scale||Standard Deviation|Mean
2764614|NCT00775203|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I) Score at Last Study Visit|"The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse."|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Week 8 Observed Cases: Trazodone = 178, placebo = 182.|||Units on the CGI-I scale||Standard Deviation|Mean
2764615|NCT00775203|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit|"The CGI-Severity (CGI-S) consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on CGI-S scale||Standard Deviation|Mean
2764616|NCT00775203|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10 item clinician-administered depression rating scale. The 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) are rated on a scale ranging from 0 (low severity/difficulty) to 6 (high severity/difficulty) with anchors at 2-point intervals. The overall total score range is from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. MADRS Week 8 Observed Cases: Trazodone = 178, placebo = 182.|||Units on MADRS scale||Standard Deviation|Mean
2764617|NCT00775203|Secondary|Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit|Change from baseline in the HAMD-17, item 1: Depressed Mood item, at each post-baseline visit. The Depressed Mood item is rated on a 5-point scale ranging from rating of 0=absent; to 4=very severe.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Points on the HAMD scale||Standard Deviation|Mean
2764618|NCT00775203|Secondary|HAMD-17 Remitters at Each Visit|Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Participants|||Number
2764619|NCT00775203|Secondary|HAMD-17 Responders at Each Visit|Number of patients who show a response (defined as at least a 50% reduction from baseline in HAMD-17 score) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Participants|||Number
2764639|NCT00775138|Primary|Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment|Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.|Day 1 through 56.|Safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.|||Participants|||Count of Participants
2764640|NCT00775021|Secondary|Overall Lens Handling|Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2764620|NCT00775203|Primary|Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline|The Hamilton Depression Rating Scale 17 items [HAMD-17] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Week 8 Last Observation Carried Forward (LOCF): Trazodone = 202, placebo = 204.|||Points on HAMD-17 scale||Standard Deviation|Mean
2764621|NCT00775190|Secondary|Side Effects (Incidence of Thromboembolic Events)|Occurrence of any thromboembolic events during the study time frame.|6 months|Study Terminated with no data analysis||||||
2764622|NCT00775190|Secondary|Side Effects (Menstrual Cramps)|Intensity of menstrual cramps reported on a 4 point Likert scale.|6 months|Study Terminated with no data analysis||||||
2764623|NCT00775190|Secondary|Side Effects (Mood Changes)|Self reported changes in mood during each month over the time frame.|6 months|Study Terminated with no data analysis||||||
2764624|NCT00775190|Secondary|Side Effects (Breast Tenderness)|Incidence of breast tenderness during the study time frame|6 Months|Study Terminated with no data analysis||||||
2764625|NCT00775190|Secondary|Side Effects (Vomiting)|Number of episodes of vomitting|6 Months|Study Terminated with no data analysis||||||
2764626|NCT00775190|Secondary|Side Effects (Nausea)|Number of days of nausea|6 months|Study Terminated with no data analysis||||||
2764627|NCT00775190|Primary|Days of Bleeding|Number of days with bleeding during each menstrual period.|6 months|Study Terminated with no data analysis||||||
2764628|NCT00775190|Primary|Incidence of Breakthrough Bleeding|Any breakthrough bleeding during reporting period.|6 months|Study Terminated with no data analysis||||||
2764629|NCT00775190|Primary|Amount of Bleeding|Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).|6 Months|Study Terminated with no data analysis.||||||
2764630|NCT00775138|Secondary|To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy||Screening to Day 56.|The analysis population is the mITT population, defined as all randomized patients who received at least one dose of study medication|||Participants|||Count of Participants
2764631|NCT00775138|Secondary|To Evaluate Change in St. George's Respiratory Questionnaire Measurements|A composite total score is derived as the sum of domain scores for symptoms, activity, and impact, with 0 as the best possible score and 100 as the worst possible score. A reduction in score of 4 points is generally recognized as a clinically meaningful improvement in quality of life. This analysis compared the changes from Day 1 (prior to first dosing) to Days 14, 28, 42, and 56.|Day 1 to Day 14, Day 28, Day 42 and Day 56.|The analysis population is the mITT population, defined as all randomized patients who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2764632|NCT00775138|Secondary|Total Pulmonary Symptom Severity Score (PSSS)|"Changes in the severity and intensity (frequency x severity) of individual symptoms and change in composite PSSS from baseline to Days 14, 28, 42 and 56.~The Pulmonary Symptom Severity Score (PSSS) was assessed on patient's responses to the Patients Symptoms Questionnaire, which employs symptom frequency and severity scales described for the validated Memorial Symptoms Assessment Scale. Symptom severity was scored on a scale of 0 (not applicable or symptom not present) to 4 (very severe) for each of the 5 symptoms (cough, shortness of breath, sputum production [frequency and severity], fatigue, and wheezing), and a composite score (range, 0 to 20 [low score represents better outcome]) was obtained as the sum of the severity scores for each symptom."|Baseline to Day 14, Day 28, Day 42 and Day 56.|The safety population is used for this analysis. It is the same as the mITT population, defined as all randomized patients who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2764633|NCT00775138|Secondary|Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.|The change in Pseudomonas aeruginosa density from from baseline to Day 14, 28, and 42 were evaluated.Treatment differences with respect to the changes from baseline to each measured study day, defined as the log10 of the sum of all morphotypes (colony-forming units [CFU]) per gram of sputum in (log10CFU/gram [g]), was estimated for each treatment group; standard deviations accompanied the treatment differences.|Baseline to Day 14, Day 28 and Day 42.|Per source, this is the Pa population, which includes patients who grew Pa on day 1, analyzed as treated.|||log10CFU per gram||Standard Deviation|Mean
2764634|NCT00775138|Primary|Serious Adverse Events up to 28 Days After Study Medication Discontinuation|Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.|Screening to Day 56|The safety population is the modified intent-to-treat (mITT) population, defined as all randomized patients who received at least 1 dose of study drug.|||Participants|||Count of Participants
2764635|NCT00775138|Primary|Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication||Screening to Day 56|The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.|||Participants|||Count of Participants
2764636|NCT00775138|Primary|Treatment-emergent PFT Abnormalities up to the End of Study|Number of Subjects with Decrease of >= 15% in FEV1 (L) from Pre- to Post-dose by Study Day|Day 1, Day 14 and Day 28|The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.|||Participants|||Count of Participants
2764637|NCT00775138|Primary|Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment|Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.|Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28|The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.|||L||Standard Deviation|Mean
2764642|NCT00775021|Secondary|End of the Day Comfort|Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2764643|NCT00775021|Secondary|Inferior Region Corneal Staining|The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2764644|NCT00775021|Primary|Overall Comfort|Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2764645|NCT00774995|Secondary|Number of Subjects That Experienced Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period after the challenge dose (1 month).||||Subjects|||Number
2764646|NCT00774995|Secondary|Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination.|During the 31-day follow-up period after the hepatitis B vaccine challenge dose.||||Subjects|||Number
2764647|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
2764648|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2764649|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2764650|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.|Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
2764651|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
2764652|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
2764653|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||μmol/day||Standard Deviation|Mean
2764708|NCT00774397|Secondary|Global Assessment of Tolerability|"The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.~Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'."|Week 24|Per protocol set|||percentage of patients|||Number
2764654|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||μg/L||Standard Deviation|Mean
2764655|NCT00774930|Secondary|"Changes From Baseline in QoL in Endocrine Symptoms Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
2764656|NCT00774930|Secondary|"Changes From Baseline in Gastrointestinal (G.I). Symptoms Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
2764657|NCT00774930|Secondary|"Changes From Baseline in Global Health Status/Quality of Life (QoL) Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.~For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
2764658|NCT00774930|Secondary|Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study|Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of subjects|||Number
2764659|NCT00774930|Secondary|Percentage of Days of Use of Other Rescue Medication|Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of days||Standard Deviation|Mean
2764660|NCT00774930|Secondary|Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Number of events per day||Standard Deviation|Mean
2764661|NCT00774930|Secondary|Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Number of events per day||Standard Deviation|Mean
2764662|NCT00774930|Primary|Percentage of Days With Subcutaneous Octreotide as Rescue Medication|Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of days||95% Confidence Interval|Least Squares Mean
2764663|NCT00774852|Secondary|Proportion of Vaccinated Participants With a Competent Immune Response|"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response - absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response - absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity."|Week 52|Intent-to-treat who completed Week 52 and were vaccinated.|||percentage of participants|||Number
2764664|NCT00774852|Secondary|Lupus Disease Activity - Total BILAG-2004|BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.|Week 52|Intent-to-treat who completed Week 52 and BILAG 2004 data available.|||units on a scale||Standard Deviation|Mean
2764665|NCT00774852|Secondary|Lupus Disease Activity - SF-36 Scores Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.|||percent change||Standard Deviation|Mean
2764666|NCT00774852|Secondary|Lupus Disease Activity - SF-36 Scores|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.|||Score||Standard Deviation|Mean
2764667|NCT00774852|Secondary|Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.|||percent change||Standard Deviation|Mean
2764668|NCT00774852|Secondary|Lupus Disease Activity - Patient Global Assessment|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.|||units on a scale||Standard Deviation|Mean
2764669|NCT00774852|Secondary|Lupus Disease Activity - Frequency of Flares|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity."|Week 52|Intent-to-treat with available data between weeks 24 and 52.|||participants|||Number
2764670|NCT00774852|Secondary|Lupus Disease Activity - Presence of Hypocomplementemia|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus."|Week 104|Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available|||participants|||Number
2764709|NCT00774397|Secondary|Change From Baseline to Week 24 in Weight of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Weight at Week 24)|||kg||Standard Deviation|Mean
2764671|NCT00774852|Secondary|Lupus Disease Activity - Negative Anti-dsDNA|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity."|Week 104|Intent-to-treat participants who completed Week 104.|||participants|||Number
2764672|NCT00774852|Secondary|Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity."|Week 104|Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.|||participants|||Number
2764673|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response|A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.|Week 52|Intent-to-treat||||||
2764674|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study|A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.|Week 104|Intent-to-treat|||participants|||Number
2764675|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response|A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
2764676|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response|A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
2764677|NCT00774852|Secondary|Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.|Week 52|Intent-to-treat|||participants|||Number
2764678|NCT00774852|Secondary|Number of Participants With a Complete or Partial Response|"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis."|Week 52|Intent-to-treat|||participants|||Number
2764679|NCT00774852|Secondary|Number of Participants With Partial Response|Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
2764710|NCT00774397|Secondary|Change From Baseline to Week 24 in Pulse Rate|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Pulse rate at Week 24)|||bpm||Standard Deviation|Mean
2764680|NCT00774852|Primary|Number of Participants With Complete Response|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
2764681|NCT00774800|Secondary|Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])|AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose.|Predose up to 4 hours after injection of study drug|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC(BG) data.|||minutes*milligrams per deciliter||90% Confidence Interval|Geometric Mean
2764682|NCT00774800|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable tmax data.|||minutes||Standard Deviation|Mean
2764683|NCT00774800|Secondary|Maximum Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable Cmax data|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
2764684|NCT00774800|Primary|Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)|"AUC was derived as the area under the serum insulin concentration profile from 0 to time t. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose."|Predose up to 60 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC0-60 data.|||nanomole*minute per liter (nmol*min/L)||Standard Deviation|Mean
2764685|NCT00774787|Other Pre-specified|Local Skin Reactions|Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|Post baseline to end of study (4-8 weeks post-treatment)|One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data.|||Scores on a scale||Standard Deviation|Mean
2764686|NCT00774787|Secondary|Cosmetic Appearance Score at 4-8 Weeks Post-treatment|Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|4-8 weeks post-treatment|Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data.|||Scores on a scale||Standard Deviation|Mean
2764687|NCT00774787|Post-Hoc|Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment|Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|4-8 weeks post-treatment|All patients enrolled.|||Participants|Participants||Number
2764688|NCT00774787|Primary|Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment|Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|Baseline, 4-8 weeks post-treatment|Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new.|||Percent change||Standard Deviation|Mean
2764689|NCT00774748|Secondary|Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)|GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.|6 time points in approximately 3 months|Included all participants who had at lease one visit and one blood draw.|||mL/min||Full Range|Mean
2764690|NCT00774748|Primary|Average Subcutaneous Anti-Xa Blood Levels|Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.|approximately 3 months|Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses. The once daily dosing sub-group was analyzed for this primary outcome measure.|||IU/mL||Full Range|Mean
2771072|NCT00731341|Primary|Number of Adverse Events|Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)|up to 4 weeks post procedure.||||Participants|||Number
2764691|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7|Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|7 days|All participants, excluding two outliers of 97% and 150%|||Percent||Full Range|Median
2764692|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port|Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|approximately 3 months|Twenty participants, excluding one outlier of 97%.|||Percent||Full Range|Median
2764693|NCT00774748|Secondary|Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels|Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|6 time points (for each participant) in approximately 3 months|All participants were represented with a baseline fluctuation in percent difference.|||Percent||Full Range|Median
2764694|NCT00774579|Secondary|Total Adipose Tissue|total adipose tissue assessed by MRI scan|6 months||||kg||Standard Deviation|Mean
2764695|NCT00774579|Primary|Intrahepatocellular Lipid (IHCL) Content|IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).|6 months||||% change from baseline||Standard Deviation|Mean
2764696|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of PegIFN at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2764697|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2764698|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2764699|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Faldaprevir at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2764700|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline Total Bilirubin)|||percentage of patients|||Number
2764701|NCT00774397|Secondary|Change From Baseline to Week 24 in Total Bilirubin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)|||mg/dL||Standard Deviation|Mean
2764702|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)|||percentage of patients|||Number
2764703|NCT00774397|Secondary|Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients|Baseline is defined as the last value before the drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)|||U/L||Standard Deviation|Mean
2764704|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Absolute Neutrophils)|||percentage of patients|||Number
2764705|NCT00774397|Secondary|Change From Baseline to Week 24 in Absolute Neutrophils of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)|||GI/L||Standard Deviation|Mean
2764706|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Haemoglobin)|||percentage of patients|||Number
2764707|NCT00774397|Secondary|Change From Baseline to Week 24 in Haemoglobin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Haemoglobin at Week 24)|||g/dL||Standard Deviation|Mean
2764711|NCT00774397|Secondary|Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure|Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)|||mmHg||Standard Deviation|Mean
2764712|NCT00774397|Secondary|Relapse|"Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.~Patients could experience relapse at any point post-treatment."|post-End of treatment (i.e. post 48 weeks)|Per protocol set|||percentage of patients|||Number
2764713|NCT00774397|Secondary|Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)|Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.|Week 24 through Week 48|Per protocol set|||percentage of patients|||Number
2764714|NCT00774397|Secondary|Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)|Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.|Up to Week 24|Per protocol set|||percentage of patients|||Number
2764715|NCT00774397|Secondary|Virological Rebound|"Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection.~Note that this is numerical rebound, not requiring confirmation with a re-measurement."|Week 24 or Week 48|Per protocol set|||percentage of patients|||Number
2764716|NCT00774397|Secondary|Time to Loss of Virological Response|"Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.~Time is expressed in Median number of days."|Week 24|Per protocol set|||Number of days||95% Confidence Interval|Median
2764717|NCT00774397|Secondary|Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection|Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)|On or after day 155 post end of all treatment|Per protocol set|||Days||Full Range|Median
2764718|NCT00774397|Secondary|Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy|Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60|Week 36 or Week 60|Per protocol set|||percentage of patients|||Number
2764719|NCT00774397|Secondary|End of Treatment Response at End of All Therapy|End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48|Week 24 or Week 48|Per protocol set|||percentage of patients|||Number
2764720|NCT00774397|Secondary|End of Treatment Response at Week 24|End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.|Week 24|Per protocol set|||percentage of patients|||Number
2764721|NCT00774397|Secondary|Complete Early Virological Response (cEVR)|Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12|Week 12|Per protocol set|||percentage of patients|||Number
2764722|NCT00774397|Secondary|Extended Rapid Virological Response (eRVR)|Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12|Week 4 and Week 12|Per protocol set|||percentage of patients|||Number
2764723|NCT00774397|Secondary|Early Virological Response (EVR)|Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12|Baseline and Week 12|Per protocol set|||percentage of patients|||Number
2764724|NCT00774397|Secondary|Virological Response at Week 4|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)|Week 4|Per protocol set|||percentage of patients|||Number
2764725|NCT00774397|Secondary|Virological Response at Week 2|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)|Week 2|Per protocol set|||percentage of patients|||Number
2764726|NCT00774397|Primary|Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy|"Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.~The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24.~Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved."|Day 155 after the end of all treatment|Per protocol set|||percentage of patients||95% Confidence Interval|Number
2764727|NCT00774397|Primary|Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo|"An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).~This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.~The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'."|Week 28|"Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations .~FAS was composed of all randomised patients who took at least 1 dose of study medication.~For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated."|||percentage of patients|||Number
2764728|NCT00774306|Secondary|Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)||8 weeks, 16 weeks|||||||
2764729|NCT00774306|Primary|Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms||8 weeks, 16 weeks|||||||
2764730|NCT00774267|Primary|Percent Change From Baseline in Mammographic Breast Density at Month 24|The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.|primary study baseline, Month 24|All available participants were analyzed. Here, ‘N’ (number of participants analyzed) signifies those participants who had technically acceptable mammograms available at primary study baseline and Month 24.|||percent change||Standard Deviation|Mean
2764731|NCT00774202|Secondary|Relative Efficacy of the 2 Groups|The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity both overall and in comparison to the previous responses to rituximab alone. The comparisons are for level of response eg CR (>100k) vs PR (230-100k) vs NR (<30k) and for duration of response-----duration of response is controlled by comparison to duration of response from initial rituximab infusions|2 years||||number of responders|||Number
2764732|NCT00774202|Secondary|Number of Participants With SAEs|How many participants had SAEs among those receiving R-CVP or among those receiving double dose rituximab and did participants in one arm have substantially more SAEs than those in the other arm|2 years||||number of patients with SAEs|||Number
2764733|NCT00774202|Primary|Efficacy of Higher Double Doses of Rituxan and of Standard Dose of Rituxan + Cyclophosphamide, Vincristine, Prednisone|"Outcome measure was determined by comparing the study participants' historical responses to their initial treatment of rituximab at standard dose/regimen without enhancement (based on duration of response and type of response) to the participants response to their study treatment responses. Thus each patient was his or her own control although all study treatments included standard dose rituximab treatments (one at double the dose and one with additional treatments)."|2 years|the number of patients in each arm that increase their platelet count consistently above 100,000/uL after treatment|||Participants|||Count of Participants
2764734|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
2764735|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
2764736|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
2764737|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
2764738|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
2764739|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
2764740|NCT00774163|Primary|Serum Creatinine||Day 5||||mg/dl||Standard Deviation|Mean
2764741|NCT00774163|Primary|Blood Urea Nitrogen||Day 5||||mg/dl||Standard Deviation|Mean
2764742|NCT00774163|Primary|Serum AST in Males||Day 5|limited to males|||units per liter (U/L)||Standard Deviation|Mean
2764743|NCT00774163|Primary|Serum Aspartate Aminotransferase (AST) in Females||Day 5|limited to females|||units per liter (U/L)||Standard Deviation|Mean
2764744|NCT00774163|Primary|Serum ALT in Males||Day 5|limited to males|||units per liter (U/L)||Standard Deviation|Mean
2764745|NCT00774163|Primary|Serum Alanine Aminotransferase (ALT) in Female Participants||Day 5|limited to females|||units per liter (U/L)||Standard Deviation|Mean
2764746|NCT00774163|Primary|Leukocyte Count on Day 5||Measured on day 5||||cells per cubic millimeter||Standard Deviation|Mean
2764747|NCT00774163|Primary|Mean Daily Temperature|Measured daily during 5 days of study product administration|5 days of study product administration||||Degrees Celcius||Standard Deviation|Mean
2764748|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|Days of observation||Number
2764749|NCT00774163|Secondary|Number of Subjects With at Least One PCR Positive Stool Specimen||Average of 36 day follow up period||||participants|||Number
2764750|NCT00774163|Primary|Number of Participants With a Positive Blood Culture for L. Reuteri|To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).|participants were followed for an average of 36 days|2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol|||participants|||Number
2764751|NCT00774046|Secondary|Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 883 days|Subset of patients undergoing autologous stem cell transplant|||Days||Full Range|Median
2764752|NCT00774046|Secondary|Overall Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 817 days|Subset of patients undergoing autologous stem cell transplant|||Days||Full Range|Median
2764753|NCT00774046|Secondary|Numbers of Stem Cells Collected||1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.|||10^6 CD34+ cells/kg||Full Range|Median
2764754|NCT00774046|Secondary|Feasibility of Stem Cell Collection|Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg|1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.|||percentage of participants||95% Confidence Interval|Number
2764755|NCT00774046|Primary|Relapse-free Survival|Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.|Up to 2000 days||||Days||Inter-Quartile Range|Median
2764756|NCT00774046|Primary|Overall Survival||Up to 2000 days||||Days||Inter-Quartile Range|Median
2765752|NCT00768469|Primary|Maximum Tolerated Dose|The maximum tolerated dose of neratinib, as determined by the incidence of DLTs, in combination with paclitaxel 80 mg/m^2, in subjects with advanced solid tumors.|From first dose day through day 28.|Patients with at least one dose of neratinib.|||mg|||Number
2764757|NCT00774046|Primary|Response to Induction Chemotherapy (CR or PR)|Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made|Day 28-40||||percentage of participants||95% Confidence Interval|Number
2764758|NCT00773968|Secondary|Percentage of Participants Who Required Red Blood Cell Transfusions||Weeks 1 to 28|Safety population.|||percentage of participants|||Number
2764759|NCT00773968|Secondary|Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP|The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP: Weeks 1 to 16; EEP: Weeks 17 to 28|Per protocol population.|||percentage of participants|||Number
2764760|NCT00773968|Secondary|Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP||EEP: Weeks 17 to 28|Per protocol population.|||days||Full Range|Median
2764761|NCT00773968|Secondary|Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP||EEP: Weeks 17 to 28|Per protocol population.|||percentage of participants||95% Confidence Interval|Number
2764762|NCT00773968|Secondary|Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)|Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.|SVP: Week -4 to Week 0; EEP: Weeks 17 to 28|Per protocol population.|||g/dL||Standard Deviation|Mean
2764763|NCT00773968|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)|The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).|EEP: Weeks 17 to 28|Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.|||percentage of participants||95% Confidence Interval|Number
2764764|NCT00773955|Secondary|Duration of Response||From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years|There were no confirmed responses qualifying for this endpoint.||||||
2764765|NCT00773955|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.~Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From registration to the earliest date documentation of disease progression, assessed up to 5 years|All 15 patients were analyzed for this endpoint.|||months||95% Confidence Interval|Median
2764766|NCT00773955|Secondary|Survival Time|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|All 15 patients were analyzed for this endpoint.|||months||95% Confidence Interval|Median
2764767|NCT00773955|Primary|Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)|"The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:~A Complete Response (CR) requires the disappearance of all target lesions~A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements."|During the first 6 courses of treatment|One patient discontinued therapy after one cycle of treatment due to persistent grade 1 thrombocytopenia. Therefore, fourteen patients were evaluable for the primary end point at the interim analysis.|||participants|||Number
2764768|NCT00773786|Secondary|Change From Baseline in Inspiratory Capacity at 1 Week|Change from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).|baseline and 2 hours after dosing||||Liters||Standard Error|Mean
2764769|NCT00773786|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at 1 Week|Change from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)|baseline and 1 week||||Liters||Standard Error|Mean
2764770|NCT00773786|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week|Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)|baseline and 1 week||||Liters||Standard Error|Mean
2764784|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 36|Intent to Treat; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
2764771|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764772|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764773|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 24|ITT; Participants who entered the extension period|||percentage of participants||95% Confidence Interval|Number
2764774|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764775|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
2764776|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
2764785|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 24|Intent to Treat; Includes participants who entered the long term extension study|||units on a scale||Standard Deviation|Mean
2764777|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
2764778|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long-term extension study|||units on a scale||Standard Deviation|Mean
2764779|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
2764780|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension study|||units on a scale||Standard Deviation|Mean
2764781|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
2764782|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
2764783|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 48|Intent to Treat; Includes participants who entered the long term extension study|||units on a scale||Standard Deviation|Mean
2764786|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 18|Intent to Treat; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
2764787|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 48|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
2764788|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 36|Intent to Treat; participants who entered into the long-term extension period|||percent change||Full Range|Median
2764789|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 24|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
2764790|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 18|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
2764791|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 48|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764792|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 36|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764793|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 24|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764794|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Month 18|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
2764795|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 196|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.||||||
2764796|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 4 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764889|NCT00773513|Secondary|Percentage of Participants With Thromboembolic Events||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
2772709|NCT00721227|Primary|Successful Gastric Plication Using Reduction Gastroplasty|The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.|Immediately post-operative||||participants|||Number
2764797|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 3 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764798|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 2 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764799|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 18 Months|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
2764800|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years|PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
2764801|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764802|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764803|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764804|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764805|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764806|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764807|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764808|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764809|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2764810|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
2772721|NCT00721188|Secondary|Volume of Distribution Based on the Terminal Phase (Vdarea)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
2764811|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; participants who entered the long-term extension study|||percentage of participants||95% Confidence Interval|Number
2764812|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; participants who entered the long-term extension study|||percentage of participants||95% Confidence Interval|Number
2764813|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks|Safety population: includes all participants who were treated with Apremilast|||participants|||Number
2764814|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase|For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.||||||
2764815|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase|For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.|Weeks 0 to 16|Includes PASI-75 responders during the placebo controlled phase.|||weeks||Full Range|Median
2764816|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase|For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to 16|Includes PASI-50 responders during the placebo controlled phase|||weeks||Full Range|Median
2764817|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0-88; up to data cut off of 21 July 2011|Includes all participants who were treated with Apremilast|||participants|||Number
2764818|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; up to data cut off of 21 July 2011|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
2765717|NCT00768651|Secondary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period|||||||
2764819|NCT00773734|Secondary|Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)|Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.|Up to 4 weeks after the last dose|Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.|||weeks||95% Confidence Interval|Median
2764820|NCT00773734|Secondary|Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.|Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study|Week 0 to 52|This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase||||||
2764821|NCT00773734|Secondary|Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52|Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0|Week 0 to Week 52|The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted||||||
2764822|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value..|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764823|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;|||units on a scale||Standard Deviation|Mean
2764824|NCT00773734|Secondary|Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764825|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764880|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
2764826|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764827|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764828|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 52|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764829|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 40|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764830|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 32|Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
2764831|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 52|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Week 52|Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;|||percent change||Standard Deviation|Mean
2764832|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 40|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Week 40|Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat|||percent change||Standard Deviation|Mean
2764833|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 32|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Week 32|Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat|||percent change||Standard Deviation|Mean
2764834|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 52|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
2764835|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 40|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
2764836|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 32|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
2764837|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 52|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 52|Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;|||percent change||Standard Deviation|Mean
2764838|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 40|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 40|Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;|||percent change||Standard Deviation|Mean
2764839|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 32|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 32|Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat|||percent change||Standard Deviation|Mean
2764840|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
2764890|NCT00773513|Secondary|Percentage of Participants With Gastrointestinal Bleeding||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
2764891|NCT00773513|Secondary|Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
2764841|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat|||percentage of participants||95% Confidence Interval|Number
2764842|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat|||percentage of participants||95% Confidence Interval|Number
2764843|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-100 During the Extension Study|For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.|Week 0 to Extension Study|Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
2764844|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-90 During the Extension Study|For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.|Week 0 to Extension study|Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
2764845|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-50 During the Extension Study|For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to Week 52|Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
2764846|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-75 During the Extension Study|For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.|Week 0 to Week 52|Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
2764847|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
2764848|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
2764849|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
2766187|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2764850|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764851|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764852|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764853|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764854|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764855|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764892|NCT00773513|Secondary|Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
2764954|NCT00773175|Secondary|Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge|Data are reported from the start of infusion to the time of ED discharge.|up to approximately 26 hours|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants with available data were analyzed.|||hours||Standard Deviation|Mean
2764856|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764857|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
2764858|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
2764859|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||hours||Full Range|Median
2764860|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||hours||Full Range|Median
2764861|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2764862|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2764863|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2764864|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2764865|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
2764893|NCT00773513|Secondary|Time to Non-Fatal and Fatal Stroke||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
2764866|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
2764867|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
2764868|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
2764869|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
2764870|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
2764871|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
2764872|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase|"The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant's hand (entire palmar surface or handprint), which equates to approximately 1% of total BSA."|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percent change||Standard Error|Least Squares Mean
2764881|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
2764873|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 24|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.||||||
2764874|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 16|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.||||||
2764875|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
2764876|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Week 16|Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
2764877|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 24|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
2764878|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 16|The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||Percent change||Standard Error|Least Squares Mean
2764879|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase|For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI 100 was not defined or analyzed as there were too few participants.||||||
2770874|NCT00732758|Secondary|Parathyroid Hormone (PTH) Dietary Data||6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing those participants with follow up data for PTH at 6 months.|||pg/mL||Standard Deviation|Mean
2764882|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
2764883|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
2764884|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
2764885|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
2764886|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
2764887|NCT00773734|Primary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 and Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
2764888|NCT00773604|Primary|The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months|Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)|Baseline and 12 months|Patients implanted and treated with DBS|||TWSTRS total score change||Full Range|Mean
2764951|NCT00773175|Secondary|Number of Participants for Which the Indicated Type of Infusion Device Was Used|Data are reported for the type of infusion device used.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764894|NCT00773513|Secondary|Time to Non-Fatal and Fatal Myocardial Infarction||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
2764895|NCT00773513|Secondary|Time to All-Cause Mortality||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.|||years||95% Confidence Interval|Median
2764896|NCT00773513|Primary|Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.|||years||95% Confidence Interval|Median
2764897|NCT00773474|Secondary|Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).||18 months|20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD>180 days per RECIST criteria.|||participants|||Number
2764898|NCT00773474|Secondary|Toxicity Profile of Lonafarib|To determine the toxicity profile of lonafarnib in this patient population.|18 months||||participants|||Number
2764899|NCT00773474|Secondary|Overall Response Rate|To determine overall response rate.|18 months|17 participants were evaluable for Overall Response Rate analysis using RECIST criteria.|||participants|||Number
2764900|NCT00773474|Primary|Progression Free Survival|To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.|18 months|20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria.|||days||95% Confidence Interval|Mean
2764901|NCT00773461|Secondary|Time to First Remission|Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Days||95% Confidence Interval|Median
2764902|NCT00773461|Secondary|Time to First Low Disease Activity|Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Days||95% Confidence Interval|Median
2764903|NCT00773461|Secondary|Percentage of Participants With ACR20 Response by First Week of Onset|ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Percentage of Participants|||Number
2764904|NCT00773461|Secondary|Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24|HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and 24 Weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2764905|NCT00773461|Secondary|Change in Hemoglobin From Baseline to Week 24|Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants|Baseline and 24 Weeks|ITT Population|||g/L||Standard Deviation|Mean
2764906|NCT00773461|Secondary|Mean Rheumatoid Factor at Baseline and Week 24|Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL.|Baseline and 24 Weeks|ITT Population|||IU/mL||Standard Deviation|Mean
2764907|NCT00773461|Secondary|Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in health status.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2764908|NCT00773461|Secondary|Percentage of Participants With Low Disease Activity and in Clinical Remission|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants analyzed.|||Percentage of Participants|||Number
2764909|NCT00773461|Secondary|Change in ESR From Baseline to Week 24|The ESR was measured in mm/hour. A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population|||mm/hour||Standard Deviation|Mean
2764910|NCT00773461|Secondary|Change in C-Reactive Protein From Baseline to Week 24|The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population|||mg/dL||Standard Deviation|Mean
2764911|NCT00773461|Secondary|Change in Participant's Global Assessment of Pain From Baseline to Week 24|"The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change indicated improvement."|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
2764912|NCT00773461|Secondary|Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
2764913|NCT00773461|Secondary|Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
2764914|NCT00773461|Secondary|Change in Tender and Swollen Joint Counts From Baseline to Week 24|"68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.~66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66."|Baseline and Week 24|ITT Population|||Joints||Standard Deviation|Mean
2764915|NCT00773461|Secondary|Number of Participants Who Received Escape Therapy|Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD.|24 Weeks|ITT Population|||Number of participants|||Number
2764916|NCT00773461|Secondary|Percentage of Participants With ACR50 and ACR70 Responses at Week 24|To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted.|Week 24|ITT Population|||Percentage of Participants|||Number
2764917|NCT00773461|Primary|Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24|To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]).|Week 24|ITT Population|||Percentage of Participants|||Number
2764918|NCT00773422|Secondary|Number of Cigarettes Smoked During the Ad-lib Period|Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.|day 8||||cigarettes||Standard Error|Mean
2764919|NCT00773422|Primary|Latency to Initiate Ad-lib Smoking Session|Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.|day 8||||minutes||Standard Error|Mean
2764920|NCT00773383|Secondary|Assessment of Potential Predictive and Prognostic Biomarkers.|Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial.|Throughout study|Responders and non-responders||||||
2764921|NCT00773383|Secondary|Population Pharmacokinetics of R1507 and Tarceva|Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial.|Throughout study|Population PK of R1507 and erlotinib||||||
2764922|NCT00773383|Secondary|Electrocardiogram (ECG)|12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided).|baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)|Safety Population|||ms (millisecond)||Standard Deviation|Mean
2764923|NCT00773383|Secondary|Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing|"Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity.~To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives."|prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)|Safety Population|||participants|||Number
2764924|NCT00773383|Secondary|Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|Within 7 days of starting treatment (baseline visit)|Female patients of childbearing potential||||||
2764925|NCT00773383|Secondary|Hemoglobin A1c (HbA1c)|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|screening|Safety Population||||||
2764952|NCT00773175|Secondary|Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration|Data are reported for the number of needle stick attempts needed to initiate fluid administration.|average of approximately 3 minutes|ITT Population|||Participants|||Count of Participants
2764926|NCT00773383|Secondary|Fasting Glucose, Highest Post-Baseline Value|A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant's baseline glucose level is reported.|Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)|Safety Population: based on the total number of participants n = 34|||participants|||Number
2764927|NCT00773383|Secondary|Baseline Electrocardiogram (ECG)|"Standard safety monitoring includes baseline Electrocardiogram (ECG).~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|baseline within 28 days of starting treatment (screening visit).|Safety Population||||||
2764928|NCT00773383|Secondary|Duration of Objective Response|This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken|All Treated Population||||||
2764929|NCT00773383|Secondary|Time to Progressive Disease (PD)|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.|All Treated Population||||||
2764930|NCT00773383|Secondary|Time to Best Response|"This is defined as time from the start of therapy to the date of first CR or PR.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population||||||
2764931|NCT00773383|Secondary|Participants Achieving Objective Response|"Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population||||||
2764932|NCT00773383|Secondary|Duration of Overall Survival|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of treatment to death; up to the time that all participants ended treatment|All Treated Population||||||
2764933|NCT00773383|Primary|Percentage of Participants With Progression Free Survival (PFS)|The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.|12 weeks|All Treated Population|||Percentage of participants|||Number
2764934|NCT00773370|Secondary|Stroke Impact Scale (SIS)|The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.|||units on a scale||Standard Error|Mean
2764935|NCT00773370|Secondary|Short Physical Performance Battery (SPPB)|The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
2764936|NCT00773370|Secondary|Balance as Measured by the Berg Balance Scale (BBS)|The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
2764953|NCT00773175|Secondary|Time From Randomization to the First Drop of Fluid Infusion|Data are reported for the time from randomization to the start of fluid infusion for all randomized participants.|up to approximately 110 and 220 minutes for the SC and IV arms, respectively|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||minutes||95% Confidence Interval|Median
2764937|NCT00773370|Primary|6 Minute Walk Test (6MWT)|Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||meters||Standard Error|Mean
2764938|NCT00773279|Secondary|Hypoglycaemic Episodes, Number of Events Per Subject Day||Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).|||events per subject-day|||Number
2764939|NCT00773279|Secondary|Number of Adverse Device Effects|Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.|From randomisation (week 0) and until 7 days after Week 24 (Visit 16)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||events|||Number
2764940|NCT00773279|Secondary|Number of Hypoglycaemic Episodes|Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.|Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||episodes|||Number
2764941|NCT00773279|Secondary|Clinical Technical Complaints (CTCs)|A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.|Weeks 0-24 (whole trial period)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||CTCs|||Number
2764942|NCT00773279|Secondary|Score for Treatment Impact Measure for Diabetes|Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any TRIM-D available results in PDS290 and FlexPen® treatment groups, respectively.|||scores on a scale||Standard Deviation|Mean
2764943|NCT00773279|Secondary|Summary Score for Treatment Satisfaction|Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available ITSQ results in PDS290 and FlexPen® treatment groups, respectively.|||scores on a scale||Standard Deviation|Mean
2764944|NCT00773279|Secondary|Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use|Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)|Week 24|ITT population. Some subjects did not have any available Niskanen Comparative Device Questionnaire results.|||percentage of participants|||Number
2764945|NCT00773279|Primary|HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®||Week 12 of each treatment sequence|Intention-to-treat (ITT) population comprising all randomised subjects and with data on HbA1c. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects dropped out during either treatment sequence.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
2764946|NCT00773253|Primary|Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale|Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).|baseline and 48 weeks|All participants that completed all phases of the study|||percent change||Standard Deviation|Mean
2764947|NCT00773253|Primary|Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)||pre-injection, week 16, 20, 36, and 40|PI left institution. Efforts to contact PI to obtain data have been unsuccessful.||||||
2764948|NCT00773175|Secondary|Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge|Participants were discharged from the ED to home or the hospital to continue hydration therapy.|from randomization up to approximately 98 hours|ITT Population. Only those participants who were re-hospitalized or had an Emergency Department visit after initial discharge to home were analyzed.|||Participants|||Count of Participants
2764949|NCT00773175|Secondary|Number of Participants Discharged From the ED to Home or the Hospital|Participants were discharged from the ED to home or the hospital to continue hydration therapy.|up to approximately 26 hours|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764950|NCT00773175|Secondary|Number of Participants for Which the Indicated Gauge for Infusion Device Was Used|Data are reported for the gauge of infusion device used.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764955|NCT00773175|Secondary|Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement|Data were collected for the number of additional personnel involved in needle placement.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764956|NCT00773175|Secondary|Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training|Data were collected for the level of staff training for the person who performed the needle placement.|average of approximately 3 minutes|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764957|NCT00773175|Secondary|Number of Participants Experiencing Reductions in Flow Rate|In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
2764958|NCT00773175|Secondary|Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration|In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764959|NCT00773175|Secondary|Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire|"A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Do you believe the method of therapy was successful in your child's rehydration?; Question 2: Have you or your child ever previously had IV fluids (for SC Group) / SC fluids (for IV Group)?; Question 3: If the response to Question 2 was yes, how does this compare to prior experience with IV (for SC Group) / SC (for IV Group)?; Question 4: Should your child(ren) need rehydration treatment in the future, would you opt for this procedure?; Question 5: Should you need rehydration treatment in the future, would you opt for this procedure?; Question 6: What is your global satisfaction with the study procedure?"|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|"ITT Population. Only participants with a response of Yes to Question 2 contributed responses for Question 3."|||Participants|||Count of Participants
2764960|NCT00773175|Secondary|Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy?|A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV).|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
2764961|NCT00773175|Secondary|Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire|A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Was the participant successfully hydrated using the randomized route of administration?; Question 2: Overall, was the procedure of fluid infusion easy to perform?; Question 3: Were there any unacceptable side effects from the therapy?; Question 4: Would you consider using this hydration therapy for this indication in the future?|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
2764962|NCT00773175|Secondary|Number of Participants With the Indicated Type of Rescue Route Therapy Administered|"Participants for whom parenteral access by the randomized route of administration could not be achieved after a reasonable number of attempts and for whom the investigator had deemed the access by that route a failure were expected to receive fluid administration by other means, designated as rescue route for the purpose of this study. This rescue route may have included venous cut-down, central venous line, interosseous access, etc., and for those participants initially randomly assigned to IV fluid administration, SC fluid administration by hylenex-facilitated infusion."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
2764963|NCT00773175|Secondary|Percent Change From Baseline in Body Weight|Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value) * 100.|Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants contributing data at the indicated time point were assessed.|||percent change||Standard Deviation|Mean
2764964|NCT00773175|Secondary|Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion|Hydration status was assessed clinically using the Gorelick 10-item scale: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate, and capillary refill time at the fingertip. Scores ranged from 0 (less severe impairment) to 10 (more severe impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants contributing data at the indicated time point were assessed.|||score on a scale||Standard Deviation|Mean
2764965|NCT00773175|Secondary|Infusion Duration During the Initial Infusion|Infusion duration was assessed as a measure of the time required to complete the initial infusion of 20 mL/kg.|first hour of infusion|ITT Population|||hours||Standard Deviation|Mean
2764966|NCT00773175|Secondary|Number of Participants With the Indicated Type of Fluid Administered|Data are reported for the initial fluid administered.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764967|NCT00773175|Secondary|Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score|The infusion site was assessed for pain at two time points: after placement of the infusion device but before fluid infusion and at the end of infusion. Pain was recorded using the FLACC pain scale for children less than 3 years of age. Scores on the scale ranged from 0 (no hurt) to 10 (hurt worst).|Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||score on a scale||Standard Deviation|Mean
2764968|NCT00773175|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure|Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2764969|NCT00773175|Secondary|Mean Change From Baseline in Respiratory Rate|Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||breaths per minute||Standard Deviation|Mean
2764970|NCT00773175|Secondary|Mean Change From Baseline in Heart Rate|Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants with available data were analyzed.|||beats per minute||Standard Deviation|Mean
2764971|NCT00773175|Secondary|Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration|Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. Not Rel Dehy = Abnormal, Not Related to Dehydration; Rel Dehy = Abnormal, Related to Dehydration. The investigator assessed findings as abnormal.|Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Safety Population. Only those participants for which fluid administration was initiated were analyzed.|||Participants|||Count of Participants
2764972|NCT00773175|Secondary|Number of Participants With the Indicated Type of Adverse Events|Adverse events (AEs) are defined as any untoward medical occurrence in a participant administered a product, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events (TEAEs) are defined as those events that occurred on or after the first injection device insertion attempt.|up to 7 days after hospital discharge|Safety Population: all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)|||Participants|||Count of Participants
2764973|NCT00773175|Secondary|Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration|The number of participants administered at least 20 mL total volume was assessed.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
2764974|NCT00773175|Secondary|Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration|The maximum flow rate was averaged over any 60-minute period of time.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||Participants|||Count of Participants
2764975|NCT00773175|Secondary|Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.|||milliliters per kilogram per hour||Standard Deviation|Mean
2764976|NCT00773175|Secondary|Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.|||milliliters per kilogram per hour||Standard Deviation|Mean
2764977|NCT00773175|Secondary|Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants|The mean flow rate was averaged over any 60-minute period of time.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.|||milliliters per kilogram per hour||Standard Deviation|Mean
2772722|NCT00721188|Secondary|Initial Volume of Distribution (Vdc)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
2764978|NCT00773175|Secondary|Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters per hour||Standard Deviation|Mean
2764979|NCT00773175|Secondary|Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants|The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters per hour||Standard Deviation|Mean
2764980|NCT00773175|Secondary|Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants|The mean flow rate was averaged over any 60-minute period of time.|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||milliliters per hour||Standard Deviation|Mean
2764981|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Randomized Participants. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.||||||
2764982|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Randomized Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were to be analyzed.||||||
2764983|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the Food and Drug Administration (FDA) removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Randomized Population: all participants who were assigned a patient randomization number||||||
2764984|NCT00773175|Secondary|Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population|||milliliters||Standard Deviation|Mean
2765005|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2765007|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Age.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2764985|NCT00773175|Primary|Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters||Standard Deviation|Mean
2764986|NCT00773175|Primary|Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.|||milliliters||Standard Deviation|Mean
2764987|NCT00773175|Primary|Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants|"It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest."|During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)|Intent-to-Treat (ITT) Population: all randomly assigned participants for whom the treatment was attempted, (i.e., infusion device placement was initiated)|||milliliters||Standard Deviation|Mean
2764988|NCT00773136|Primary|Efficacy of Bimatoprost in Lengthening of Eyelashes|Eyelash growth after application of bimatoprost vs control (split face study).|4.5 months (6 weeks of drug application and 3 months after discontinuing)||||mm||Standard Deviation|Mean
2764989|NCT00773097|Secondary|Number of Participants With Adverse Events Associated With the Study Agent|Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.|54 weeks||||participants|||Number
2764990|NCT00773097|Secondary|Number of Participants With Autoimmune Response to Muc-1 Vaccine|Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.|52 weeks||||participants|||Number
2764991|NCT00773097|Primary|Number of Participants With Anti Muc-1 Antibody|Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.|52 weeks|Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate|||participants|||Number
2764992|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
2764993|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
2765006|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2765411|NCT00771472|Secondary|Part I: Maximum Drug Concentration (Cmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||µM||Standard Deviation|Geometric Mean
2764994|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
2764995|NCT00772967|Primary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
2764996|NCT00772954|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.||Day 0 up to 70 days post first vaccination|Safety assessments were on the safety population.|||Participants|||Number
2764997|NCT00772941|Secondary|Number of Participants With Continuous Abstinence Situation by 52 Weeks.|Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.|52 weeks|No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.|||participants|||Number
2764998|NCT00772941|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of unlisted treatment related adverse events.|||events|||Number
2764999|NCT00772941|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
2765000|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.|||participants|||Number
2765001|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.|||participants|||Number
2765002|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.|||participants|||Number
2765003|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.|Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.|||participants|||Number
2765004|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2765008|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2765009|NCT00772928|Other Pre-specified|Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™|Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.|0-3 days post- vaccination and entire study period|Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.|||Percentage of Participants|||Number
2765010|NCT00772928|Primary|Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.|60 Days Post-dose 3|Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population|||All Units||95% Confidence Interval|Geometric Mean
2765011|NCT00772928|Primary|Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.|28 to 48 days post-3rd vaccination|Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2765012|NCT00772915|Secondary|Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)|The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below.|Duration on treatment (up to 18 cycles from registration)||||Participants|||Count of Participants
2765013|NCT00772915|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|Time from registration to progression or death (up to 3 years)||||months||95% Confidence Interval|Median
2765014|NCT00772915|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method|Time from registration to death (up to 3 years)||||months||95% Confidence Interval|Median
2765015|NCT00772915|Secondary|Confirmed Response Rate|"Confirmed response rate is defined as the percentage of participants who achieved a response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Up to 18 cycles from registration||||percentage of participants||95% Confidence Interval|Number
2765016|NCT00772915|Primary|Progression-free Survival (PFS) Rate at 12 Months|"PFS rate at 12 months is defined as the percentage of participants who are alive and progression-free at 12 months. Progression is exclusively defined as a patient with progressive disease while receiving treatment with lenalidomide in combination with dexamethasone. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|12 months from registration||||percentage of participants||95% Confidence Interval|Number
2765017|NCT00772889|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 21-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765018|NCT00772889|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.|||fold increase||95% Confidence Interval|Mean
2765019|NCT00772889|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
2765409|NCT00771472|Secondary|Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||hours||Standard Deviation|Geometric Mean
2765020|NCT00772889|Secondary|The Number of Subjects Seroprotected by HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
2765021|NCT00772889|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
2765022|NCT00772889|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||titer||95% Confidence Interval|Geometric Mean
2765023|NCT00772889|Secondary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-364.|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765024|NCT00772889|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765025|NCT00772889|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765026|NCT00772889|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765027|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765028|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2765029|NCT00772889|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2765030|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2765031|NCT00772889|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2765032|NCT00772889|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2765033|NCT00772772|Secondary|1, 25-OH Vitamin D||after 8 weeks of vitamin D therapy|||||||
2765034|NCT00772772|Secondary|25-hydroxy Vitamin D (25-OH Vitamin D)|25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.|after 8 weeks of vitamin D therapy|Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol.|||ng/ml||Standard Error|Mean
2765035|NCT00772772|Secondary|Nuclear Magnetic Resonance (NMR) Lipoprotein Profile||after 8 weeks of vitamin D therapy|||||||
2765036|NCT00772772|Secondary|Intestinal Permeability||after 8 weeks of vitamin D therapy|||||||
2765037|NCT00772772|Secondary|Blood Pressure||after 8 weeks of vitamin D therapy|||||||
2765038|NCT00772772|Primary|Change in Endotoxin Activity|Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).|baseline and 8 weeks|Per protocol. Result is expressed as change in endotoxin activity with therapy|||EA units||Standard Deviation|Mean
2765039|NCT00772707|Primary|Comfort Ratings at 30 Days|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|30 days|5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).|||Percentage of Participants|||Number
2765040|NCT00772707|Primary|Comfort Ratings at Baseline|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|Baseline (Day 0)|6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).|||Percentage of Participants|||Number
2765041|NCT00772668|Secondary|Rate of Toxicity in Study Participants|Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants|Up to 5 years||||participants|||Number
2765042|NCT00772668|Secondary|Overall Survival (OS)|Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact.|Up to 5 years||||months|||Number
2765043|NCT00772668|Secondary|Progression-free Survival (PFS)|Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact.|Up to 5 years||||months|||Number
2765044|NCT00772668|Primary|Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)|"Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC):~Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL;~Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow;~Partial Response (PR) includes >= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen."|Post cycles 2,4,6,8 and then every 3 months, about 2 years|A minimum enrollment of 30 participants was required for this outcome measure. Due this minimum requirement not being met, and the early termination of the study due to lack of funding, the data for this outcome measure were not analyzed.||||||
2765045|NCT00772629|Primary|Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.|Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.|Day 28 post-vaccination|SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Participants|||Number
2765046|NCT00772603|Secondary|Seizure Free Rate, ITT, (M)|Percent of patients seizure-free during Maintenance, Intent-to-Treat population|At the end of 12 weeks (Maintenance Period)|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.|||percentage of patients|||Number
2765047|NCT00772603|Secondary|Seizure-Free Rates, ITT|Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of patients|||Number
2765060|NCT00772538|Secondary|ACQ at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2765048|NCT00772603|Secondary|Responder Rate, ITT|Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of patients|||Number
2765049|NCT00772603|Secondary|PCH(M)- ITT|Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population|Change at 12 weeks (Maintenance Period) compared to Baseline|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.|||percentage of change||95% Confidence Interval|Median
2765050|NCT00772603|Primary|PCH(T), ITT|Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.|Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of change||Full Range|Median
2765051|NCT00772590|Primary|Mean Change From Baseline CD4+ Cell Count|Comparison of normalised mean change from baseline CD4+ cell count|24 weeks|intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.|||Cells/microlitre||Standard Deviation|Mean
2765052|NCT00772577|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP)|To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2765053|NCT00772577|Secondary|Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)|To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).|||Percentage of patients|||Number
2765054|NCT00772577|Secondary|Percentage of Patients Achieving Blood Pressure Control During 8 Weeks|The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).|||Percentage of patients|||Number
2765055|NCT00772577|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2765056|NCT00772577|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2765057|NCT00772538|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.417 (NCT00776984) and the Present 205.416 (NCT00772538)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)|||percentage of participants|||Number
2765058|NCT00772538|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Puffs||Standard Error|Mean
2765059|NCT00772538|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Days||Standard Error|Mean
2765061|NCT00772538|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2765062|NCT00772538|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2765063|NCT00772538|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
2765064|NCT00772538|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
2765065|NCT00772538|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
2765066|NCT00772538|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As <50percent (10 of 222 patients in the placebo group and 8 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
2765067|NCT00772538|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
2765068|NCT00772538|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
2765069|NCT00772538|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS..|||Participants|||Number
2765070|NCT00772538|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS..|||Participants|||Number
2765071|NCT00772538|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As <50percent (68 of 222 patients in the placebo group and 53 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
2765072|NCT00772538|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Percent||Standard Error|Mean
2765073|NCT00772538|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
2765074|NCT00772538|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
2765075|NCT00772538|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
2765076|NCT00772538|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
2765077|NCT00772538|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765078|NCT00772538|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765079|NCT00772538|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765080|NCT00772538|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765081|NCT00772538|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765082|NCT00772538|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765083|NCT00772538|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765084|NCT00772538|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765085|NCT00772538|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765086|NCT00772538|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765087|NCT00772538|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||Days||Inter-Quartile Range|Median
2765088|NCT00772538|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
2765089|NCT00772538|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.|||Liter||Standard Error|Mean
2765090|NCT00772447|Secondary|Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC|This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 48 patients indentified staphylococcus aureus infection both in daptomycin group and in comparator group.|||Percentage of patients|||Number
2765091|NCT00772447|Secondary|Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC|This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 33 patients indentified MSSA infection in daptomycin group and 37 patients indentified with MSSA in comparator group.|||Percentage of patients|||Number
2765092|NCT00772447|Secondary|Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)|This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.|baseline and TOC, for up to 4 weeks|There were 14 patients indentified MRSA infection in daptomycin group and 10 patients indentified with MRSA in comparator group.|||Percentage of patients|||Number
2765093|NCT00772447|Secondary|Microbiological Response at EOT(End of Therapy)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.|baseline and EOT, for up to 2 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 86 strains isolated from 81 patients in daptomycin arm and 88 strains from 81 patients in comparator arm who met the criteria of ME population at EOT visit.|||Percentage of strains|Participants||Number
2765094|NCT00772447|Secondary|Microbiological Response at TOC(Test of Cure)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.|baseline and TOC, for up to 4 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 83 strains isolated from ME population of daptomycin arm(78 patients) and 86 strains from ME population in comparator arm(79 patients).|||Percentage of strains|Participants||Number
2765095|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and EOT(end of therapy), for up to 2 weeks|There were 110 patients in daptomycin arm and 103 patients in comparator arm who both completed EOT visit and met the criteria of CE population|||Percentage of patients|||Number
2765111|NCT00772148|Primary|Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)|||ng/mL*hr||Standard Deviation|Mean
2765112|NCT00772148|Secondary|Number of Participants Who Died Within the 360 Days.|Number of patients who died was compared between the two groups during the study.|360 days||||participants|||Number
2765096|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and TOC, for up to 4 weeks|There were 107 patients in daptomycin arm and 101 patients in comparator arm meeting the criteria of CE population and completed TOC visit.|||percentage of patients|||Number
2765097|NCT00772447|Primary|Shift in ECG|percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had both measurements at baseline and TOC visit and those who got normal ECG resluts at baseline were included in the summary. Change=TOC visit-baseline|||percentage of patients|||Number
2765098|NCT00772447|Primary|Change in Urine pH||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements were included in the summary of a specific parameter at a specific time point. Change = TOC visit - baseline|||pH||Standard Deviation|Mean
2765099|NCT00772447|Primary|Change in Serum Total Creatine Phosphokinase (CPK)||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||IU/L||Standard Deviation|Mean
2765100|NCT00772447|Primary|Change in Creatinine Clearance||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||ml/min||Standard Deviation|Mean
2765101|NCT00772447|Primary|Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)|Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||percentage||Standard Deviation|Mean
2765102|NCT00772382|Secondary|The Change in Serum Phosphorus From Baseline to Week 52||52 weeks|Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)|||mg/dL||95% Confidence Interval|Mean
2765103|NCT00772382|Primary|Number of Adverse Events (AE)||52 weeks||||participants|||Number
2765104|NCT00772369|Primary|Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.|"SAE: any untoward medical occurrence with the following outcomes:~death,~a life-threatening adverse drug experience (as confirmed by the investigators),~inpatient hospitalization or prolongation of existing hospitalization,~a persistent or significant disability/incapacity, or~a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)"|6 Months post 4th dose vaccination|Response to questionnaire that were confirmed by the primary care physician’s office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis.|||Participants|||Number
2765105|NCT00772369|Primary|Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series|"Positive response is a 'Yes' to any of the following questions:~Has your child been admitted to a hospital?~Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office?~Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?~Has your child been diagnosed by a physician as having:~Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?"|6 months post 4th dose vaccination|Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.|||Particpants|||Number
2765106|NCT00772304|Secondary|Taste and Aftertaste of Medication||5 min, 45 min.|||||||
2765107|NCT00772304|Primary|Product Preference Questionnaire for Immediate Taste|Using a set of coded responses, subjects evaluated product preference in regards to immediate taste|5 min post-dose||||Percentage of participants|||Number
2765108|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|14 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
2765109|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|7 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
2765110|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|1 day|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
2765113|NCT00772148|Primary|Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)|||ng/mL||Standard Deviation|Mean
2765114|NCT00772109|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to 7 Days post vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
2765115|NCT00772109|Secondary|Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroprotection was defined as a HAI antibody titer ≥ 1:40."|Before and 28 Days post-vaccination|4-Fold increase in antibody levels were analyzed in h per-protocol population|||Percentage of Participants|||Number
2765116|NCT00772109|Primary|Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination."|28 Days post-vaccination|Seroprotection was analyzed in the per-protocol population|||Percentage of Participants|||Number
2765117|NCT00772109|Primary|Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines|The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay|Baseline (Day 0) and 28 Days post-vaccination|Geometric Mean Titers (GMTs) were analyzed in the per-protocol population|||Titer||95% Confidence Interval|Geometric Mean
2765118|NCT00772070|Primary|Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.||Day 0 and Days 8 and 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2765119|NCT00772070|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.||Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Percentage of participants|||Number
2765120|NCT00772070|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.||Baseline to Day 8 and Day 28 post-vaccination|Fold rise analysis was assessed in per-protocol population with valid serology data.|||Percentage of participants|||Number
2765121|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 Months||||units on a scale||Standard Deviation|Mean
2765122|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2765123|NCT00772031|Secondary|Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|baseline and 6 months post randomization|per protocol|||units on a scale||Standard Deviation|Mean
2765124|NCT00772031|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months|MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).|Baseline and 6 months|per protocol|||units on a scale||Standard Deviation|Mean
2765125|NCT00772031|Secondary|Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months|Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).|Baseline and 6 months|The number who completed the Beck's Depression Inventory at baseline and three months|||units on a scale||Standard Deviation|Mean
2765126|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days||6 months|All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months|||participants|||Number
2765447|NCT00770809|Secondary|Pathologic Stage in the Breast and Axilla|Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.|At time of surgery|||||||
2765127|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days||6 months post randomization|All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure|||participants|||Number
2765128|NCT00772031|Primary|Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline|(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).|Baseline (pre-randomization), months 5 and 6 post randomization|ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.|||Moderate to severe headache days||Standard Deviation|Mean
2765129|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765130|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765131|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765132|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765133|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765134|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765135|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765299|NCT00771953|Primary|Progression Free Survival|For determining progression-free survival, progression was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization until the first date that recurrent or progressive disease is objectively documented.||||days||95% Confidence Interval|Median
2765136|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765137|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765138|NCT00772005|Secondary|Change From Baseline to Week 24 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
2765139|NCT00772005|Secondary|Change From Baseline to Week 12 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
2765140|NCT00772005|Secondary|Change From Baseline to Endpoint in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
2765141|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765142|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765143|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
2765144|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765321|NCT00771810|Secondary|Chemotherapy Dose Intensity and Dose Density|Mean percentage of cycles where projected (target) chemotherapy dose was maintained|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
2765145|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.|||percentage of participants|||Number
2765146|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765147|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765148|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765149|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765150|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765151|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
2765152|NCT00772005|Secondary|Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765153|NCT00772005|Secondary|Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765154|NCT00772005|Secondary|Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765155|NCT00772005|Secondary|Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765156|NCT00772005|Secondary|Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765157|NCT00772005|Secondary|Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765158|NCT00772005|Secondary|Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765159|NCT00772005|Secondary|Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765160|NCT00772005|Secondary|Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765161|NCT00772005|Secondary|Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765322|NCT00771810|Secondary|Treatment Cycles With Platelets Counts Below 25,000/mm3|Mean percentage of treatment cycles where platelets counts were below 25,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
2765323|NCT00771810|Secondary|Subjects With Platelet Counts Below 50,000/mm3|Number of subjects who experienced a platelet count below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765162|NCT00772005|Secondary|Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765163|NCT00772005|Secondary|Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765164|NCT00772005|Secondary|Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765165|NCT00772005|Secondary|Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765166|NCT00772005|Secondary|Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765167|NCT00772005|Secondary|Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765168|NCT00772005|Secondary|Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765169|NCT00772005|Secondary|Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765324|NCT00771810|Primary|Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3|Mean percentage of cycles with platelet counts below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
2765170|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765171|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765172|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765173|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765174|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765175|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765176|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765177|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765325|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Bothersome|"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal."|Day 10|Intent-to Treat population.|||percent of participants|||Number
2765178|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765179|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765180|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765181|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765182|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765183|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765184|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765185|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765186|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2773009|NCT00719329|Primary|Colonization at Day 1 Swab|Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.|First week of life|Intention to Treat|||Participants|||Number
2765187|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
2765188|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
2765189|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
2765190|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
2765191|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minus errors||Standard Error|Least Squares Mean
2765192|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minus errors||Standard Error|Least Squares Mean
2765193|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minue errors||Standard Error|Least Squares Mean
2765194|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
2765326|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming|"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal."|Day 10|Intent-to Treat population.|||percent of participants|||Number
2765327|NCT00771758|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.|||percenatage of participants|||Number
2765195|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
2765196|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
2765197|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement."|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765198|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement."|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765199|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement."|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765200|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765201|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765202|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765328|NCT00771758|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.|||percenatage of participants|||Number
2765203|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765204|NCT00772005|Secondary|Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765205|NCT00772005|Secondary|Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 22|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765206|NCT00772005|Secondary|Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765207|NCT00772005|Secondary|Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 18|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765208|NCT00772005|Secondary|Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765209|NCT00772005|Secondary|Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 14|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765210|NCT00772005|Secondary|Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765329|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
2765330|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
2765211|NCT00772005|Secondary|Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 10|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765212|NCT00772005|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765213|NCT00772005|Secondary|Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 6|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765214|NCT00772005|Secondary|Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765215|NCT00772005|Secondary|Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765216|NCT00772005|Secondary|Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765217|NCT00772005|Secondary|Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765218|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765331|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
2765332|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
2765219|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765220|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765221|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765222|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765223|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765224|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765225|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765226|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765333|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
2765227|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765228|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765229|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765230|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765231|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765232|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765233|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765234|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2771595|NCT00728481|Secondary|Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy|Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.|Baseline, 6 months||||participants|||Number
2765235|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765236|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765237|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765238|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765239|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765240|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765241|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765242|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765334|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
2765335|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
2765243|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765244|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765245|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765246|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765247|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765248|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765249|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765250|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765336|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
2765251|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765252|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765253|NCT00772005|Secondary|Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765254|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765255|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765256|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765257|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765258|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765259|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765260|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765261|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765262|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765263|NCT00772005|Secondary|Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765264|NCT00772005|Secondary|Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765265|NCT00772005|Secondary|Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765266|NCT00772005|Secondary|Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765267|NCT00772005|Secondary|Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765268|NCT00772005|Secondary|Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765269|NCT00772005|Secondary|Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765270|NCT00772005|Secondary|Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765271|NCT00772005|Secondary|Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765272|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765273|NCT00772005|Secondary|Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765274|NCT00772005|Secondary|Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2772185|NCT00724815|Secondary|Nausea Free at Two Hours|Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
2765275|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765276|NCT00772005|Secondary|Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765277|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765278|NCT00772005|Secondary|Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765279|NCT00772005|Secondary|Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765280|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
2765281|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765282|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765337|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
2765283|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765284|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765285|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765286|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765287|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765288|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765289|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765290|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765338|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
2765291|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765292|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765293|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765294|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765295|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765296|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2765297|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
2765298|NCT00772005|Primary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
2772186|NCT00724815|Secondary|Phonophobia Free at Two Hours|Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
2765300|NCT00771927|Secondary|The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population|||Treatment-Emergent Adverse Events|||Number
2765301|NCT00771927|Primary|The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population|||Treatment-Emergent Adverse Events|||Number
2765302|NCT00771914|Primary|the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment|The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.|4 hours|Each participant acted as own control since each received the intervention (placebo, aspirin, lovaza, and both aspirin and lovaza) and had these effects compared to baseline (four hour effect of each intervention).|||seconds||Standard Deviation|Mean
2765303|NCT00771901|Secondary|VLDL-triglyceride (TG) Concentration||Baseline and four weeks||||mmol/l||Standard Deviation|Mean
2765304|NCT00771901|Secondary|Insulin Sensitivity in the Liver|HISI (hepatic insulin sensitivity index). HISI is the inverse of the product of endogenous glucose production and plasma insulin concentration and provides an index of how well circulating insulin controls the amount of glucose supplied by the liver. A higher number is indicative of greater insulin sensitivity.|Baseline and four weeks||||100/ (µmol/min * uIU/mL)||Standard Deviation|Mean
2765305|NCT00771901|Primary|Body Composition|Fat mass (%)|Baseline and four weeks||||percentage||Standard Deviation|Mean
2765306|NCT00771875|Secondary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)||1 year||||participants|||Number
2765307|NCT00771875|Secondary|Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy||90 days||||participants|||Number
2765308|NCT00771875|Secondary|Incidence of Death||90 days||||participants|||Number
2765309|NCT00771875|Secondary|Mean Serum Creatinine|Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation|7, 14, 28, 60, 90 days and 1 year post therapy initiation||||mg/dL||Standard Deviation|Mean
2765310|NCT00771875|Secondary|Renal Allograft Survival||1 year after rejection treatment||||participants|||Number
2765311|NCT00771875|Secondary|Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy||Day 1||||participants|||Number
2765312|NCT00771875|Primary|Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection|"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.~Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal."|1 year||||participants|||Number
2765313|NCT00771849|Secondary|Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.||28 days post-vaccination|SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.|||Participants|||Number
2765314|NCT00771849|Primary|Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.||Day 0 (before) and 28 days post-vaccination|SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2765315|NCT00771810|Secondary|Rescue Treatment for Hematopoiesis and Mucositis|"Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:~Transfusions~Filgrastim or Pegfilgrastim~Erythropoietin~Palifermin"|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765316|NCT00771810|Secondary|Alopecia|Number of subjects with a treatment emergent adverse event of alopecia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765317|NCT00771810|Secondary|Mucositis|Number of subjects with a treatment emergent adverse event of mucositis|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765318|NCT00771810|Secondary|Anemia|Number of subjects with a treatment emergent adverse event of anemia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765319|NCT00771810|Secondary|Neutropenia|Number of subjects with a treatment emergent adverse event of neutropenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765320|NCT00771810|Secondary|Lymphopenia as Determined by Lymphocyte Count|Number of subjects with a treatment emergent adverse event of lymphopenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
2765341|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Placebo)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
2765342|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
2765343|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via Interactive Voice Response (IVR) system in the morning."|10 days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
2765344|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 10|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 10|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
2765345|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 5|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 5|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
2765346|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 3|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 3|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
2765347|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 2|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 2|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
2765348|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study|"The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.~Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved."|Day 10|Intent-to-Treat subjects.|||second||Standard Deviation|Mean
2765349|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study|The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.|||chair stands||Standard Deviation|Mean
2765350|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study|The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.|Day 10|Intent-to-Treat subjects.|||seconds||Standard Deviation|Mean
2765351|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study|The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.|||meters||Standard Deviation|Mean
2765352|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.|10 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765353|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.|5 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765354|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765410|NCT00771472|Secondary|Part I: Time at Which Cmax Occurs (Tmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||hours||Full Range|Median
2765355|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765356|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 10 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765357|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 5 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.|5 Days (120 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765358|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 3 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765359|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 2 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765360|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 10 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765361|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 5 Days (SPID120)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.|5 Days (120 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765362|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 2 Days (SPID48)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765363|NCT00771758|Secondary|50% Responder Rate on Day 10.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
2765364|NCT00771758|Secondary|30% Responder Rate on Day 10.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
2765365|NCT00771758|Secondary|50% Responder Rate on Day 5.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
2765366|NCT00771758|Secondary|30% Responder Rate on Day 5.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
2765367|NCT00771758|Secondary|50% Responder Rate on Day 3.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
2765368|NCT00771758|Secondary|30% Responder Rate on Day 3.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
2765369|NCT00771758|Primary|Sum of Pain Intensity Difference Over 3 Days (SPID72)|"Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.~The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects."|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
2765370|NCT00771745|Secondary|Malignancy||Undefined|||||||
2765371|NCT00771745|Secondary|Serum Creatinine||Post-operative days 1-7, 30, 90 and 6 months|||||||
2765372|NCT00771745|Secondary|Severity of Biopsy-proven Rejection Using Banff 97 Criteria||Not defined|||||||
2765373|NCT00771745|Secondary|Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection||Not defined|||||||
2765374|NCT00771745|Secondary|Incidence of Infections||Not defined|||||||
2765375|NCT00771745|Secondary|Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.||Ongoing|||||||
2765376|NCT00771745|Primary|Composite End Point of Acute Rejection, Graft Loss or Patient Death|Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death|6 months|Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose).|||participants|||Number
2765377|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765378|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)|As measured by a CDAI score of < 150 points.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765379|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 8|As measured by a CDAI score of < 150 points.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765380|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 8|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765381|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 4|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 4|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765382|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 6|As measured by a CDAI score of < 150 points.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765383|NCT00771667|Primary|Number of Participants With Clinical Response at Week 6|As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
2765384|NCT00771615|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
2765385|NCT00771615|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination."|From Day 0 to Day 42|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
2765386|NCT00771615|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
2765387|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
2765388|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Participants|||Count of Participants
2765389|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765390|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765391|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765392|NCT00771615|Secondary|Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765393|NCT00771615|Secondary|Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
2765394|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||fold change||95% Confidence Interval|Geometric Mean
2765395|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2766188|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2765396|NCT00771615|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765397|NCT00771615|Secondary|HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
2765398|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||fold change||95% Confidence Interval|Geometric Mean
2765399|NCT00771615|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
2765400|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 0 to Day 42 and at Day 0 to Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765401|NCT00771615|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
2765402|NCT00771615|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765403|NCT00771615|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Participants|||Count of Participants
2765404|NCT00771602|Secondary|52 Week Toxicity Rate|The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.|52 weeks|||||||
2765405|NCT00771602|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.|52 weeks or until disease progression|||||||
2765406|NCT00771602|Primary|Number of Patients With Molecular Remissions at 52 Weeks|Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.|52 weeks|No analysis available participant ineligible for evaluation; study terminated due to slow accrual.||||||
2765407|NCT00771537|Primary|Willingness to Participate in a HIV Vaccine Clinical Trial|Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).|Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.|Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.|||units on a scale||Standard Deviation|Mean
2765408|NCT00771537|Primary|Number of Participants Who Accepted Rapid HIV Testing.|Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.|During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.||||participants|||Number
2766189|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2765412|NCT00771472|Primary|Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)|"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):~Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC~Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment~Grade 4 neutropenia lasting at least 5 days~Grade 4 thrombocytopenia~Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator~Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies"|Day 1 to Day 28||||participants|||Number
2765413|NCT00771472|Secondary|Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||µM*hr||Standard Deviation|Geometric Mean
2765414|NCT00771472|Primary|Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)|A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.|Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)||||participants|||Number
2765415|NCT00771407|Secondary|Stoma Quality of Life||Serially over 24 months|||||||
2765416|NCT00771407|Secondary|Stoma Complications||more than 1 month postoperatively|||||||
2765417|NCT00771407|Secondary|Stoma Complications||30 days|||||||
2765418|NCT00771407|Primary|Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.||24 months|Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).|||participants|||Number
2765419|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.||||||
2765420|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.||||||
2765421|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|5 to 9 days post therapy|This analysis was not completed due to early termination of the study.||||||
2765422|NCT00771277|Secondary|Zarit Burden Inventory|Caregiver burden, as measured by the 12-item Zarit Burden Interview (Bédard et al., 2001; Zarit, Reever, & Bach-Peterson J, 1980). Burden includes concepts such as lack of time because of care, strain, restriction of life, etc. Items are scored from never (0) to nearly always (4), and higher total scores indicate greater burden. Total scores range from 0 to 88.|baseline||||units on a scale||Standard Deviation|Mean
2765423|NCT00771277|Secondary|PHQ-9|The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) assesses caregiver depression and anxiety on a scale from not at all (0) to nearly every day (3), with higher total scores indicating greater symptoms. Scores range from 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.|baseline||||units on a scale||Standard Deviation|Mean
2765424|NCT00771277|Primary|Number of Participants Who Reported 5 Themes|Six caregivers of TBI patients were interviewed; responses were transcribed and coded; inter-rater agreement was calculated. Themes were lack of understanding about TBI and its long-term effects and the differences between TBI and PTSD, privacy concerns, independence, fear of negative employment/financial repercussions, and difficulty in interactions with the Department of Defense (DoD) and the Department of Veterans Affairs (VA)|collected over 3 interviews of approximately 1 hour each||||participants|||Number
2765425|NCT00771264|Primary|"The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis."|A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.|13 weeks|Intent to treat|||participants|||Number
2765426|NCT00771238|Secondary|Cost of Rental Beds|Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only|End of study|Tertiary Care ICU patients|||US Dollars|||Number
2765427|NCT00771238|Primary|Indicence of Pressure Ulcers|New pressure ulcers were assessed|at the end of study period (21 days)|Tertiary Care ICU patients|||participants|||Number
2765428|NCT00771173|Primary|Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments|The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.|24 hours|Per Protocol|||centimeters||Standard Deviation|Mean
2765429|NCT00771056|Secondary|Time to Next Treatment|number of months to time from last HCQ dose to next CLL treatment|1 yr|only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose|||months||Full Range|Mean
2765430|NCT00771056|Primary|Percentage of Participants With Response|Percentage of participants with a reduction of the absolute lymphocytic count- ALC|1 yr||||percentage of participants|||Number
2765431|NCT00770991|Primary|Change in Burden of Rectal Polyps|The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.|Baseline and 36 weeks||||polyp number x mm||Standard Deviation|Mean
2765432|NCT00770991|Secondary|Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.|A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.|baseline and 36 weeks||||percentage of brown staining of cells||Standard Deviation|Mean
2765433|NCT00770991|Primary|Change From Baseline to End of Study in Number of Rectal Polyps||Baseline and 36 weeks||||polyps||Standard Deviation|Mean
2765434|NCT00770965|Secondary|Investigator Global Assessment (IGA) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32|||||||
2765435|NCT00770965|Secondary|Change From Baseline in PASI|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, weeks 12, 14, 16, 20, 24, 28 and 32|||||||
2765436|NCT00770965|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, week 4|||||||
2765437|NCT00770913|Primary|Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)|Grade N indicates a normal appearance of lower esophageal mucosa|8 weeks|The primary analysis was on the full analysis set (FAS) population.|||Percentage of Participants|||Number
2765438|NCT00770874|Secondary|Progression Free Survival, Safety|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment|Full analysis set|||months||95% Confidence Interval|Median
2765439|NCT00770874|Primary|Overall Survival||From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months|Full analysis set|||months||95% Confidence Interval|Median
2765440|NCT00770861|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).|The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)||||mm Hg||Standard Deviation|Mean
2765441|NCT00770861|Primary|Change From Baseline in Trough Seated DBP at Week 8(LOCF).|The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)||||mm Hg||Standard Deviation|Mean
2765442|NCT00770809|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3|The type and grade of treatment-related toxicity will be tabulated by treatment arm.|Up to 30 days post-treatment|||||||
2765443|NCT00770809|Secondary|Time to First Failure|Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.|Time from study entry to any recurrence ( up to 10 years)|||||||
2765444|NCT00770809|Secondary|Relapse-free Survival (RFS)|Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.|Time from surgery to any recurrence (up to 10 years)|||||||
2765445|NCT00770809|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method|Time from randomization to death or last follow-up (up to 10 years)|||||||
2765446|NCT00770809|Secondary|Radiographic Response Rate (at Completion of Neoadjuvant Therapy)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).|Week 16|||||||
2765448|NCT00770809|Primary|pCR Rate|Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.|At time of surgery|Participants who did not start protocol therapy or withdrew prior to surgery are excluded. Participants who did not undergo surgery are considered no having a pCR.|||percentage of participants||95% Confidence Interval|Number
2765449|NCT00770770|Primary|Visual Acuity|To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.|3 months||||Letters||Standard Error|Mean
2765450|NCT00770757|Post-Hoc|Survival Rate of CC-4047 Responders||Median follow-up 5.6 years (4.2-5.6 years)|Five participants have died and these were the participants who did not respond or were removed from study prior to cycle 3 due to adverse events.|||percentage of participants|||Number
2765451|NCT00770757|Post-Hoc|Chronic Graft-versus-host Disease Global Score at the Start/End of the Study|"Global scoring of chronic GvHD consists of questions about various organs including skin, genital tract, lungs, liver, and multiple others. The physician scores each organ from 0 to 3. Score 0 means the patient has no symptoms. Score 1 means the patient has mild symptoms. Score 2 means the patient has moderate symptoms. Score 3 means the patient has severe syptoms.~Mild scoring of chronic GvHD is only 1 or 2 organs or site (except the lung). No clinically significant functional impairment (maximum of score 1 in all affected organs or sites)~Moderate scoring of chronic GvHD is at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) or 3 or more organs or sites with no clinically significant functional impairment (maximum of 1 in all affected orgnas or sites)~Severe scoring of chronic GvHD is a major disability caused by chronic GvHD (score of 3 in any organ or site) and lung function score >=2."|1 year after last dose of CC-4047||||participants|||Number
2765452|NCT00770757|Post-Hoc|Organ System Response||1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable|||participants|||Number
2765453|NCT00770757|Secondary|Safety as Measured by the Most Common Adverse Effects and Reasons for Dose Reductions or Study-discontinuation|-Toxicities will be graded according to the NCI CTCAE v3.0.|30 days after last dose of CC-4047 or until resolution of event||||participants|||Number
2765454|NCT00770757|Primary|Overall Response (Complete Response + Partial Response + Other)|"CR is defined as complete resolution in all of signs and symptoms at all affected organs and tissues~PR is defined as improvement in greater than or equal to 1 organ/tissue with no progression in any other affected organ/tissue~Improvement in chronic GvHD symptoms less than what meets the definition of a PR is defined as other~Progressive disease is defined as failure of therapy to control chronic GvHD despite increasing the dose of primary therapy or adding second line treatments~No response is defined as no change in disease."|1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable|||participants|||Number
2765455|NCT00770692|Secondary|Mean Change From Baseline in Total Number of Awakenings|Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||Number of Awakenings||Standard Deviation|Mean
2765456|NCT00770692|Secondary|Mean Change From Baseline in Total Sleep Time|Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
2765467|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (3.00).|The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765718|NCT00768651|Secondary|C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function. Ther|After the 3 month washout period|||||||
2765457|NCT00770692|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO)|Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
2765458|NCT00770692|Primary|Incidence of Adverse Events|"Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.~An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF."|Up to 25 weeks (24 weeks treatment period & 1 week follow-up)|Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.|||Percentage of Participants|||Number
2765459|NCT00770692|Secondary|Mean Change From Baseline In Sleep Latency|Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
2765460|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Legs||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.||||||
2765461|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Arms||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.||||||
2765462|NCT00770679|Primary|Mean Change in Low Density Lipoprotein (LDL)|Serum LDL, mg/dL (baseline LDL-follow-up LDL)|Change from baseline to follow-up, up to 5 weeks|3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up|||mg/dL||Standard Deviation|Mean
2765463|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (60.00).|The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765464|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (30.00).|The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765465|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (12.00).|The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765466|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (6.00).|The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765719|NCT00768651|Secondary|HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period|Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.|After the 3 month washout period|||||||
2765468|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (1.20).|The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765469|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.60%)|The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765470|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.30%).|The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
2765471|NCT00770653|Secondary|Change From Baseline in Von-Willebrand Factor.|The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Error|Least Squares Mean
2765472|NCT00770653|Secondary|Change From Baseline in E-Selectin.|The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
2765473|NCT00770653|Secondary|Change From Baseline in Platelet Function.|The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||sec||Standard Error|Least Squares Mean
2765474|NCT00770653|Secondary|Change From Baseline in Thromboxane B2.|The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||pg/mL||Standard Error|Least Squares Mean
2765475|NCT00770653|Secondary|Change From Baseline in Soluble Vascular Cell Adhesion Molecule.|The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
2765476|NCT00770653|Secondary|Change From Baseline in Soluble Intracellular Adhesion Molecule.|The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
2765477|NCT00770653|Secondary|Change From Baseline in Matrix Metallo Proteinase-9.|The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
2765478|NCT00770653|Secondary|Change From Baseline in Soluble CD40 Ligand.|The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||pg/mL||Standard Error|Least Squares Mean
2765479|NCT00770653|Secondary|Change From Baseline in Nitrotyrosine.|The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||nmol/L||Standard Error|Least Squares Mean
2765480|NCT00770653|Secondary|Intake of Study Medication Greater Than 80% and Less Than 120%.|The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||participants|||Number
2765481|NCT00770653|Secondary|Change From Baseline in Diastolic Blood Pressure.|The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mmHg||Standard Deviation|Least Squares Mean
2765482|NCT00770653|Secondary|Change From Baseline in Systolic Blood Pressure.|The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mmHg||Standard Error|Least Squares Mean
2765483|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).|The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/L||Standard Deviation|Mean
2765484|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Original).|The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/L||Standard Error|Least Squares Mean
2765485|NCT00770653|Secondary|Change From Baseline in Adiponectin.|The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||μg/mL||Standard Error|Least Squares Mean
2765486|NCT00770653|Secondary|Change From Baseline in Fasting Glucose.|The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765487|NCT00770653|Secondary|Change From Baseline in Fasting Intact Proinsulin.|The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||pmol/L||Standard Error|Least Squares Mean
2765488|NCT00770653|Secondary|Change From Baseline in Glycosylated Hemoglobin.|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765489|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol.|The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765490|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Subfractions.|The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765491|NCT00770653|Secondary|Change From Baseline in Triglycerides.|The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765492|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.|The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765493|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol.|The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765546|NCT00770146|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2765494|NCT00770653|Primary|The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.|The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
2765495|NCT00770588|Secondary|Adverse Event|Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated.|AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored||||Participants|||Number
2765496|NCT00770588|Secondary|Symptom Improvement|Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement.|at randomization, every 6 weeks until disease progression, and at discontinuation.||||Participants|||Number
2765497|NCT00770588|Secondary|Disease Control Rate (DCR)|DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase|Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.|||||||
2765498|NCT00770588|Secondary|Objective Tumour Response (ORR)|The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.||||Participants|||Number
2765499|NCT00770588|Secondary|Overall Survival (OS)|The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive.|The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.||||month||95% Confidence Interval|Median
2765500|NCT00770588|Primary|Progression Free Survival (PFS)|PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.||||month||95% Confidence Interval|Median
2765501|NCT00770562|Secondary|Percentage of Participants With an Initial Complete Response|Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.|||percentage of participants|||Number
2765502|NCT00770562|Secondary|Percentage of Participants With an Initial Response|Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.|||percentage of participants|||Number
2765503|NCT00770562|Primary|Percentage of Participants With a Sustained Response|Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.|Week 24|The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (<) 1 dose of study medication, and who had at least 1 follow-up contact.|||percentage of participants|||Number
2765504|NCT00770510|Primary|Sleep Latency (SL)|The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Standard Deviation|Mean
2765505|NCT00770510|Secondary|Number of Awakenings (Objective & Subjective)|"Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Number of awakenings||Full Range|Median
2765506|NCT00770510|Secondary|Wake Time After Sleep Onset (WASO)- Objective & Subjective|"Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Full Range|Median
2765507|NCT00770510|Secondary|Sleep Efficiency|"Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.~PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Percentage of time asleep of 8 hours||Full Range|Median
2765508|NCT00770510|Secondary|Total Sleep Time (Objective & Subjective)|"Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Full Range|Median
2765509|NCT00770510|Primary|Latency To Persistent Sleep (LPS)|The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Standard Deviation|Mean
2765510|NCT00770484|Primary|Maximal Oxygen Consumption Capacity (VO2 Max)||Over approximately 30 minutes, within 2 hours of receiving each intervention.||||mL/kg/min||Standard Error|Mean
2765511|NCT00770432|Primary|Number of Participants With a Complete Resolution at the Final Visit|A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.|24 hours to 3 days after last dose of seven day treatment period.|Per-Protocol Population|||Participants|||Number
2765512|NCT00770367|Secondary|NOx f2-isoprostanes|Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress|3 months|36 adults with diabetes enrolled in the study, and 31 completed the 7-month protocol. Adherence with medication was 93% during the trial according to pill counts at the final visit. Participants were allowed to take their other regular medications during the trial.|||Oxidative stress||Standard Error|Mean
2765513|NCT00770367|Primary|Asymmetric Dimethylarginine (ADMA) Level|Labs measured micro moles per liter of ADMA levels in participants.|3 months|Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.|||umol/L||95% Confidence Interval|Mean
2765514|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at TOC|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
2765515|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at EOT|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
2765547|NCT00770146|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2765516|NCT00770341|Secondary|EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
2765517|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
2765518|NCT00770341|Secondary|EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
2765519|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)|"Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).~MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline."|7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)|MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population.|||Participants|||Number
2765520|NCT00770328|Secondary|Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.||Baseline and 8 weeks|Unable to complete analysis due to TNF-a assay failure (see Outcome measure #3)||||||
2765521|NCT00770328|Secondary|Change in TNF-alpha Level||Baseline and 8 weeks|TNF-a assay did not work properly. Meaningless data resulted including negative values which are impossible.||||||
2765522|NCT00770328|Secondary|Change in CRP Level||Baseline and 8 weeks||||mg/dl||Standard Error|Mean
2765523|NCT00770328|Primary|Change in PAI-1 Level||Baseline and 8 weeks||||ng/ml||Standard Error|Mean
2765524|NCT00770315|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
2765525|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
2765526|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
2765527|NCT00770315|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
2765528|NCT00770315|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
2765529|NCT00770289|Secondary|Number of Participants With Residual Symptoms in Case of Non Remission|Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||participants|||Number
2765530|NCT00770289|Secondary|Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)|HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.|Baseline, Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2765531|NCT00770289|Secondary|Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)|Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2765532|NCT00770289|Primary|Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)|Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.|Week 12|Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2765533|NCT00770224|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2765534|NCT00770224|Secondary|Response Rate|Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of the following. Positron emission tomography (PET) must be negative if no pre-treatment PET scan or when the PET was positive before therapy. If the PET scan was negative before therapy, all nodal masses must have regressed. no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. PR is ≥ 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD. In patients with no pre-treatment PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression|Eligible and evaluable patients were included in the analysis.|||Participants|||Count of Participants
2765535|NCT00770224|Secondary|5-year Overall Survival|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|0-5 years|Eligible and evaluable patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2765852|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Uric Acid|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Micromole/Liter||Standard Error|Least Squares Mean
2765536|NCT00770224|Secondary|5-year Progression-free Survival|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.|0-5 years|Eligible and evaluable patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2765537|NCT00770224|Primary|Percentage of Participants With 3-year Progression-free Survival (PFS)|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.|0-3 years|Eligible and evaluable patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2765538|NCT00770211|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale|"Patient's assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
2765539|NCT00770211|Secondary|Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS|The investigator's assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder as having a rating of none or mild|||Participants|||Number
2765540|NCT00770211|Secondary|1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale|"Patient's assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
2765541|NCT00770211|Secondary|Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)|The investigator's assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder defined as having a rating of none or mild|||Participants|||Number
2765542|NCT00770211|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator's assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient's assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.|||Particpants|||Number
2765543|NCT00770146|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2765544|NCT00770146|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2765545|NCT00770146|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||ratio||Standard Deviation|Mean
2765548|NCT00770146|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2765549|NCT00770146|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2765550|NCT00770146|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2765551|NCT00770146|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2765552|NCT00770146|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2765553|NCT00770146|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2765554|NCT00770146|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2765555|NCT00770146|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2765556|NCT00770146|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2765557|NCT00770146|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2765558|NCT00770146|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2765559|NCT00770146|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2765560|NCT00770146|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2765750|NCT00768521|Secondary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 1|All patients|||Percentage change||90% Confidence Interval|Least Squares Mean
2765561|NCT00770146|Primary|Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2765562|NCT00770146|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald's calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Inter-Quartile Range|Median
2765563|NCT00770120|Secondary|Frequency and Severity of Toxicities||Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.|Number of Subjects With Greater Than Grade 2 Toxicity|||participants|||Number
2765564|NCT00770120|Secondary|Overall Survival|Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Every 8 weeks until disease progression, up to 3 years.||||months||95% Confidence Interval|Median
2765565|NCT00770120|Secondary|Response|A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.|Every 8 weeks until disease progression, up to 3 years.||||percentage of overall response rate||95% Confidence Interval|Number
2765566|NCT00770120|Primary|Progression-Free Survival|Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease|Every 8 weeks until disease progression, up to 3 years.||||months||95% Confidence Interval|Median
2765567|NCT00770029|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale.|"Patient's assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
2765568|NCT00770029|Secondary|Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS.|The investigator's assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
2765569|NCT00770029|Secondary|1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale.|"Patient's assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
2765570|NCT00770029|Secondary|Responders at Rest at Day 30 by Investigator's Rating on FWS.|The investigator's assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
2765571|NCT00770029|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on Facial Wrinkle Scale (FWS) and by Patient's Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator's assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient's assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.|||Participants|||Number
2765572|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 12||||newtons||Standard Deviation|Mean
2765573|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 8||||newtons||Standard Deviation|Mean
2765574|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient's arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 4||||newtons||Standard Deviation|Mean
2765575|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 12|One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.|||units on a scale||Standard Deviation|Mean
2765576|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 8||||units on a scale||Standard Deviation|Mean
2765577|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 4||||units on a scale||Standard Deviation|Mean
2765578|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 12||||units on a scale||Standard Deviation|Mean
2765579|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 8||||units on a scale||Standard Deviation|Mean
2765580|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 4||||units on a scale||Standard Deviation|Mean
2765581|NCT00769860|Secondary|Heat Shock Protein 70 (HSP70) Levels in the Tissue|Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.|Change from Baseline to Month 4||||ng/100ng myosin||Standard Deviation|Mean
2765582|NCT00769860|Primary|Count of Adverse Events Reported|Measure reflects the total number of adverse events reported during course of the study.|Month 12||||adverse events reported|||Number
2765583|NCT00769704|Secondary|Response Interval|Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per Investigator assessment.|||months||95% Confidence Interval|Median
2765584|NCT00769704|Secondary|Time to Treatment Failure|"Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis.~Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.~Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent to treat population|||months||95% Confidence Interval|Median
2765585|NCT00769704|Secondary|Response Onset|Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.|||months||95% Confidence Interval|Median
2765586|NCT00769704|Secondary|Duration of Response|The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.|||months||95% Confidence Interval|Median
2765587|NCT00769704|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points.~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2765588|NCT00769704|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.|From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.|Intent-to-treat population|||months||95% Confidence Interval|Median
2765589|NCT00769704|Primary|Durable Response Rate|"Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.|||percentage of participants||95% Confidence Interval|Number
2765590|NCT00769652|Primary|Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
2765591|NCT00769652|Primary|Change in Weight||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
2765592|NCT00769652|Primary|Change in Fat Free Mass (FFM)||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
2765593|NCT00769600|Secondary|Tumor Metabolic Activity|Tumor metabolic activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.|3 years|Data was not collected to assess this outcome measure.||||||
2765594|NCT00769600|Secondary|Tumor Blood Flow|Tumor blood flow activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.|3 years|Data was not collected to assess this outcome measure.||||||
2765595|NCT00769600|Primary|RECIST Response|Number of participants with partial response (PR), stable disease (SD) and progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)|Up to 3 years||||Participants|||Count of Participants
2765596|NCT00769600|Primary|Progression Free Survival as Measured by Number of Days Without Disease Progression||1 year||||days||Full Range|Median
2765597|NCT00769600|Primary|Overall Survival|Median number of days alive|up to 3 years||||days||95% Confidence Interval|Median
2765598|NCT00769561|Secondary|TMD Related Symptoms|TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 ('not at all') to 4 ('very high intensity') (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson's r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach's alpha level in the current sample was excellent (α = .93).|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up||||units on a scale||Standard Deviation|Mean
2765599|NCT00769561|Primary|Jaw Use Limitations (JDL)|Jaw use limitations were measured using the Jaw Disability List (JDL) from the RDC/TMD. The JDL asks the patient to rate interference with eleven oral activities, for example chewing or talking. We used an 11-point numeric rating scale (from 0 'no limitation' to 10 'maximum limitation') instead of ratings of 'yes' and 'no' (range 0 - 110). Higher values indicate higher levels of jaw use limitations. Cronbach's alpha was .86 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
2765600|NCT00769561|Secondary|Pain Coping (FESV)|Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach's alpha level was α = .80.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
2765601|NCT00769561|Secondary|General Anxiety Symptoms (GAD-7)|General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 ('not at all') to 3 ('more than half of the days') rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach's alpha level in the current sample was α = .64.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
2765602|NCT00769561|Secondary|Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)|Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 ('less than 1 day') to 3 ('5 to 7 days') (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach's alpha level in the current sample was α = .89.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
2765853|NCT00767806|Secondary|Participants Who Discontinued From Baseline to 12 Weeks|Reasons for discontinuation are listed in the participant flow.|baseline, 12 weeks|All randomized participants.|||participants|||Number
2765603|NCT00769561|Secondary|Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)|Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach's alpha level was α = .88.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
2765604|NCT00769561|Primary|Pain Disability (Pain Disability Index)|Pain related disability was assessed using the Pain Disability Index (PDI). The PDI is a brief self-rating scale which assesses the level of pain related disability in seven areas of daily life (e.g., social activity, self-care) on a 0 (no disability) -10 (maximum disability) numeric rating scale (range 0 - 70). Higher values indicate higher disability levels. Cronbach's alpha was .87 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2765605|NCT00769561|Primary|Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))|"Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):~Characteristic pain intensity was calculated by averaging ratings of current pain, average pain, and worst pain in the past month on a numeric rating scale from 0 (no pain) to 10 (maximum pain), as recommended by RDC/TMD (range 0 - 10). Higher values indicate higher pain levels."|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2765606|NCT00769483|Other Pre-specified|Correlation Between Plasma IGF-I Expression in Patients Treated With MK-0646 and OS|"IGF1 expression in plasma was measured in patients and correlated with 1 year patients survival.~Inadequate biopsy data for outcome measure."|After completing treatment|||||||
2765607|NCT00769483|Other Pre-specified|Correlation Between Tissue IGF-I Expression in Patients Treated With MK-0646 and OS|IGF1 expression in tissue was measured and correlated with 1 year patients survival. Inadequate biopsy data for outcome measure.|After completing treatment|||||||
2765608|NCT00769483|Secondary|Treatment Toxicity|Number of patients who developed toxicity from treatment according to the National Cancer Institute's Common Terminology Criteria|Through the treatment cycles||||Participants|||Count of Participants
2765609|NCT00769483|Secondary|Overall Response Rate|Complete response + Partial response using RECIST (Response Evaluation Criteria in Solid Tumors)|From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year)|For any group that was not analyzed for Overall Response Rate outcome the number of participants has been set to be zero.|||Participants|||Count of Participants
2765610|NCT00769483|Secondary|Overall Survival|Time interval (in months) from date of randomization until the date of death from any cause|From date of randomization until the date of death from any cause, assessed up to 100 months|For any group that was not analyzed for Overall Survival (OS) outcome the number of participants has been set to be zero.|||months||95% Confidence Interval|Median
2765611|NCT00769483|Primary|Progression Free Survival|Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|For any group that was not analyzed for Progression Free Survival (PFS) outcome the number of participants has been set to be zero.|||months||95% Confidence Interval|Median
2765612|NCT00769483|Primary|MK-0646 Maximum Tolerable Dose|MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib|up to 12 cycles|The primary endpoint is MTD which was analyzed based on phase I participants only. Phase II (Arms A and B) or phase II expansion participants were not included in the analysis per design.|||participants|||Number
2765613|NCT00769392|Secondary|Discomfort From Anesthesia Used Prior to Intravitreal Injections|Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).|16 weeks||||units on a scale||Full Range|Mean
2765614|NCT00769392|Primary|Discomfort Associated With the Intravitreal Injection|Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)|16 weeks||||units on a scale||Full Range|Mean
2765615|NCT00769314|Secondary|Patient Assessment of Efficacy of the Treatment|At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.|||participants|||Number
2765616|NCT00769314|Secondary|Patient Satisfaction With Treatment|At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.|||participants|||Number
2765617|NCT00769314|Secondary|Symptom Intensity (Visual Analogue Scale [VAS])|"Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from 0 was measured in millimeters (0 - 100) and recorded."|Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)|This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication.|||units on a scale (0 - 100)||Standard Deviation|Mean
2765618|NCT00769314|Secondary|Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up|Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.|||participants|||Number
2765619|NCT00769314|Secondary|Time to Recurrence of Non-aborted Lesions During 9-month Follow-up|Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.|||Days||95% Confidence Interval|Median
2765620|NCT00769314|Primary|Time to Healing (TTH) of Vesicular Primary Lesion|Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.|Assessed from time of treatment initiation through Day 14|The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing).|||Days||95% Confidence Interval|Median
2765621|NCT00769314|Secondary|TTH of Aborted Primary Lesions|TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions.|||Days||95% Confidence Interval|Median
2765622|NCT00769314|Secondary|Time to Cessation of Symptoms|Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the ITT population.|||Days||95% Confidence Interval|Median
2765623|NCT00769314|Secondary|Duration of Episode (DOE)|For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last.|Assessed from initiation of treatment to Day 14|This endpoint was analyzed using the ITT population.|||Days||95% Confidence Interval|Median
2765624|NCT00769314|Secondary|TTH of Non-primary Lesions (Aborted Lesions Excluded)|TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions.|||Days||95% Confidence Interval|Median
2765625|NCT00769314|Secondary|Abortion of Primary Lesions|Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time.|||participants|||Number
2765626|NCT00769184|Secondary|Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions|Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval.|Weeks 2, 6, & 12|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.|||Mean Percent Improvement||Full Range|Mean
2765627|NCT00769184|Primary|Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.|Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.|Weeks 2, 6, & 12.|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.|||percentage of participants|||Number
2765628|NCT00769132|Secondary|Prostaglandin I Metabolite (PGI-M)|The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
2765629|NCT00769132|Primary|Urinary 11-dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
2765630|NCT00769119|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765898|NCT00767338|Primary|Number of Live Births After Eight Cycles of Infertility Treatment.||January 2009 to January 2012|The participants analyzed correspond to the number of participants who completed the study. In two of the arms, the study was terminated before participants were randomized to those arms.|||participants|||Number
2765631|NCT00769119|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765632|NCT00769119|Secondary|Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765633|NCT00769119|Secondary|Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765634|NCT00769119|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765635|NCT00769119|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765636|NCT00769119|Secondary|Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765637|NCT00769119|Secondary|Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765638|NCT00769119|Secondary|Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765639|NCT00769119|Primary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
2765640|NCT00769119|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||events|||Number
2765751|NCT00768521|Primary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 7|All patients|||Percentage change||90% Confidence Interval|Least Squares Mean
2765641|NCT00769119|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2765642|NCT00769119|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2765643|NCT00769119|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/s||Standard Error|Least Squares Mean
2765644|NCT00769119|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2765645|NCT00769119|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2765646|NCT00769119|Primary|Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2765647|NCT00769119|Primary|24-hour Sputum Weight(g)|Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||g||Standard Error|Least Squares Mean
2765648|NCT00769119|Primary|Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765649|NCT00769119|Primary|Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2765650|NCT00769067|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.|Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||weeks||95% Confidence Interval|Median
2765651|NCT00769067|Secondary|Duration of Response (DR)|Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Analysis population included sub-set of participants from ITT population who had a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
2765720|NCT00768651|Secondary|Acute Insulin Response to Arginine After the 3 Month Washout Period|An intravenous Arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.|3 months - washout period|||||||
2765652|NCT00769067|Secondary|Best Overall Response (BOR)|Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||participants|||Number
2765653|NCT00769067|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
2765654|NCT00769067|Primary|Progression-Free Survival (PFS)|PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||weeks||95% Confidence Interval|Median
2765655|NCT00769067|Other Pre-specified|Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)|"Only participants from Dacomitinib treatment arm were planned to be analyzed for this outcome."|C1D10-14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis population: all participants who received >=1 dose of study medication, with treatment assignments designated according to actual study treatment received, and from whom at least 1 PK sample was obtained. Here “n” signifies participants who were evaluable at specified time-point.|||ng/mL||Standard Deviation|Mean
2765656|NCT00769067|Other Pre-specified|Soluble Protein Biomarkers Level|Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.|Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)|Biomarker analysis population: participants who received >=1 dose and had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. “N”(number of participants analyzed): participants evaluable for this measure; “n”: participants evaluable at each time-point for each arm respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2765657|NCT00769067|Other Pre-specified|Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation|"Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as unknown. Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR."|Baseline|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. The participants under the category EGFR T790M Mutation are already included in the EGFR Mutant category.|||participants|||Number
2765658|NCT00769067|Secondary|Dermatology Life Quality Index (DLQI)|DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.|Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. Here “N” (number of participants analyzed) signifies participants evaluable for this measure; “n” signifies participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2765669|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)|Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: <LLN-30; Gr 2: <30-20; Gr 3&4: <20.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765721|NCT00768651|Primary|Weight Change From Baseline After 6 Months of Therapy|Measuring the weight change from baseline at months: 1, 3, 6 and 9.|6 months|||||||
2765659|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.|||participants|||Number
2765660|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.|||participants|||Number
2765661|NCT00769015|Secondary|Quality of Life: Social Function|Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2765662|NCT00769015|Secondary|Quality of Life: Role Functioning|Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2765663|NCT00769015|Secondary|Quality of Life: Mental Health|Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2765664|NCT00769015|Secondary|Vision Function: Near Activities|Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2765665|NCT00769015|Secondary|Quality of Life: Dependency|Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2765666|NCT00769015|Secondary|Vision Function: Distance Activities|Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2765667|NCT00769015|Primary|Depression|The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.|4 months||||participants|||Number
2765668|NCT00768989|Secondary|Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4|AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765714|NCT00768716|Primary|Acetaminophen Plasma Clearance Association With Race/Ethnicity|Plasma total clearance of acetaminophen in plasma measured by HPLC|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765670|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4|Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765671|NCT00768989|Secondary|Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants|ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765672|NCT00768989|Secondary|Raltegravir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Standard Deviation|Mean
2765673|NCT00768989|Secondary|Atazanavir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Standard Deviation|Mean
2765674|NCT00768989|Secondary|Atazanavir Individual Inhibitory Quotient (IQ)|Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Units on a Scale||Full Range|Geometric Mean
2765675|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval|AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
2765676|NCT00768989|Secondary|Raltegravir AUC (0-12h) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
2765677|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
2765678|NCT00768989|Secondary|Raltegravir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
2765679|NCT00768989|Secondary|Atazanavir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng*h / mL||Standard Deviation|Geometric Mean
2765680|NCT00768989|Secondary|Raltegravir Cmin 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
2765681|NCT00768989|Secondary|Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
2765682|NCT00768989|Secondary|Raltegravir Tmax|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Full Range|Geometric Mean
2765683|NCT00768989|Secondary|Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Full Range|Geometric Mean
2765684|NCT00768989|Secondary|Raltegravir Cmax in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
2765685|NCT00768989|Secondary|Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
2765686|NCT00768989|Secondary|Mean Change From Baseline in Electrocardiogram Findings|The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.|From Baseline to Week 24|All randomized participants who received at least 1 dose of study medication.|||msec||Standard Error|Mean
2765687|NCT00768989|Secondary|Mean Change From Baseline in Total Bilirubin Level||From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication.|||mg/dL||Standard Error|Mean
2765688|NCT00768989|Secondary|Baseline and Mean Change From Baseline in Total Cholesterol Levels|The mean change from baseline in participant fasting lipids was determined using fasting serum samples.|From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication. N=number of participants analyzed; n=number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
2765715|NCT00768651|Secondary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|After the 3 month washout period|||||||
2765689|NCT00768989|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.|Week 1 to Week 96, continuously|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765690|NCT00768989|Secondary|Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count||From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.|||cells/mm^3||Standard Error|Mean
2765691|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96||At Week 96 from Baseline|This analysis was not preformed due to early termination of the study.|||Participants|||Number
2765692|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48||At Week 48 from Baseline|The study terminated early, and this analysis was only done at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.|||Participants|||Number
2765693|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24|NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765694|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96|Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases.|At Weeks 48 and 96 from Baseline|The study terminated early, and this analysis was done only at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.|||Participants|||Number
2765695|NCT00768989|Secondary|Number of Nonresponders at Week 8|Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.|At Week 8 from Baseline|The first 60 participants randomized, who received at least 1 dose of study medication.|||Participants|||Number
2765696|NCT00768989|Primary|Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24|The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2765697|NCT00768898|Primary|Conjunctival Staining at 5 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|5 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
2765698|NCT00768898|Primary|Conjunctival Staining at 4 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|4 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
2765699|NCT00768898|Primary|Conjunctival Staining at 3 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|3 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
2765700|NCT00768898|Primary|Conjunctival Staining at 2 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|2 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
2765701|NCT00768898|Primary|Conjunctival Staining at 1 Minute|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|1 minute after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
2765716|NCT00768651|Secondary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period|||||||
2765702|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||units on a scale||95% Confidence Interval|Mean
2765703|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||units on a scale||95% Confidence Interval|Mean
2765704|NCT00768755|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Subgroup of participants from the FA population with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
2765705|NCT00768755|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2765706|NCT00768755|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2765707|NCT00768755|Primary|Progression-Free Survival (PFS)|"Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was Death) or from the end of study data."|Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Full analysis (FA) population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2765708|NCT00768716|Primary|APAP Plasma Adduct Association With UGT2B15 Genotype|The association of UGT2B15 genotype with APAP plasma adduct concentrations|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765709|NCT00768716|Primary|Acetaminophen Glucuronidation Partial Clearance Association With UGT2B15 Genotype|The association of acetaminophen glucuronidation partial clearance with UGT2B15 genotype|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765710|NCT00768716|Primary|Acetaminophen Plasma Clearance Association With UGT2B15 Genotype|The association of UGT2B15 genotype with acetaminophen total clearance|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765711|NCT00768716|Primary|Acetaminophen Oxidation Partial Clearance Association With Race/Ethnicity|Acetaminophen oxidation partial clearance determined from plasma clearance and urinary metabolite excretion|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765712|NCT00768716|Primary|Acetaminophen Sulfation Partial Clearance Association With Race/Ethnicity|Acetaminophen sulfation partial clearance determined from plasma clearance and urinary metabolite excretion|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765713|NCT00768716|Primary|Acetaminophen Glucuronidation Partial Clearance Association With Race/Ethnicity|Acetaminophen glucuronidation partial clearance determined from plasma clearance and urinary metabolite excretion|2 days||||mL/min/kg||Inter-Quartile Range|Median
2765722|NCT00768651|Primary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy||6 months|||||||
2765729|NCT00768651|Primary|Change From Baseline of GLP-1 Level After One Month of Therapy|Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.|Baseline and One month|||||||
2765730|NCT00768651|Primary|Mean Daily Insulin Use (U/Day) After 6 Months of Therapy|Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.|6 months|||||||
2765731|NCT00768651|Primary|Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy||6 months|||||||
2765732|NCT00768651|Primary|Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy|HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.|6 months|||||||
2765733|NCT00768651|Primary|Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy||6 months|||||||
2765734|NCT00768651|Secondary|Insulin Dose (U/Day)||After the 3 month washout period|||||||
2765735|NCT00768651|Secondary|Insulin Independence After the 3 Month Washout Period|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|After the 3 month washout period|Per Protocol Set of participants; The subset of participants in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary and secondary variables.|||% of insulin indipendent participants|||Number
2765736|NCT00768651|Primary|The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|6 months|Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.|||proportion of participants||95% Confidence Interval|Number
2765737|NCT00768599|Secondary|Mycological Cure: Mocassin Disease|Negative KOH and negative fungal culture at Day 43|43|MITT|||Participants|||Number
2765738|NCT00768599|Secondary|Mycological Cure: Interdigital Disease|Negative KOH and negative fungal culture at Day 43|43|MITT|||Participants|||Number
2765739|NCT00768599|Secondary|Effective Treatment: Mocassin Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT|||Participants|||Number
2765740|NCT00768599|Primary|Complete Cure Rate: Moccasin Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|43 Days|MITT|||Participants|||Number
2765741|NCT00768599|Secondary|Effective Treatment: Interdigital Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT|||Participants|||Number
2765742|NCT00768599|Primary|Complete Cure Rate: Interdigital Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|Day 43|MITT|||Participants|||Number
2765743|NCT00768560|Secondary|Target Blood Pressure Achievement in All Subjects|Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
2765744|NCT00768560|Secondary|Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder|Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
2765745|NCT00768560|Secondary|Target Blood Pressure Achievement in Non-elderly (<65)|Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
2765746|NCT00768560|Secondary|Target Blood Pressure Achievement in Elderly (≥65)|Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
2765747|NCT00768560|Secondary|Differences of Diastolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis|||mm Hg||Standard Deviation|Mean
2765748|NCT00768560|Secondary|Differences of Systolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis|||mm Hg||Standard Deviation|Mean
2765749|NCT00768560|Primary|Change of Sitting Blood Pressure|Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])|Baseline and after 2 weeks treatment|Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.|||mm Hg||Standard Error|Least Squares Mean
2765753|NCT00768469|Secondary|Duration of Response|Number of weeks from the time at which measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date on which recurrence or progressive disease (PD) is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started, for responders only, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first disease progression, up to 71 weeks.|Patients with Partial Response (PR) or Complete Response (CR) in the evaluable population.|||weeks||95% Confidence Interval|Median
2765754|NCT00768469|Secondary|Progression Free Survival|Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.|From first dose date to progression/death, up to 78 weeks.|Subjects who met the eligibility criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 follow-up tumor assessment at approximately cycle 2 (week 8). In the case of disease progression prior to week 8, a clinical assessment of progressive disease was adequate.|||weeks||95% Confidence Interval|Median
2765755|NCT00768469|Secondary|Objective Response Rate|Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression/death or last tumor assessment, up to 78 weeks.|Subjects who met the eligibility criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 follow-up tumor assessment at approximately cycle 2 (week 8). In the case of disease progression prior to week 8, a clinical assessment of progressive disease (PD) was adequate.|||percentage of participants||95% Confidence Interval|Number
2765756|NCT00768469|Primary|Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events|The incidence of DLTs in subjects with advanced solid tumors, treated with neratinib in combination with paclitaxel 80 mg/m^2. DLT was defined as any neratinib plus paclitaxel related Grade 3 or 4 nonhematologic toxicity or Grade 4 hematologic toxicity with few exceptions.|From first dose day through day 28.|Patients with at least one dose of neratinib.|||percentage of participants.|||Number
2765757|NCT00768430|Primary|MADRS|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.|24 hours post-infusion||||units on a scale||95% Confidence Interval|Mean
2765758|NCT00768300|Secondary|Percentage of Participants Who Developed PH on Study|The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.|Up to 48 weeks|Participants in the Full Analysis Set without PH at baseline were analyzed.|||percentage of participants|||Number
2765759|NCT00768300|Secondary|Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
2765760|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)|The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
2765761|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
2765762|NCT00768300|Secondary|Change in 6MWT at Week 48|The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||meters||Standard Deviation|Mean
2765763|NCT00768300|Secondary|Change in DLCO % Predicted at Week 48|DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||percent change in DLCO % predicted||Standard Deviation|Mean
2765764|NCT00768300|Secondary|Change in FVC % Predicted at Week 48|FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||percent change in FVC % predicted||Standard Deviation|Mean
2765765|NCT00768300|Secondary|Proportion of Participants With No Disease Progression or Death at 48 Weeks|The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.|Baseline and Week 48|Full Analysis Set|||percentage of participants|||Number
2765766|NCT00768300|Primary|Time to Death or Disease (IPF) Progression.|"The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:~Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days~Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan~All-cause mortality"|Up to 48 months|Full Analysis Set: participants who were randomized and treated|||weeks||Inter-Quartile Range|Median
2765767|NCT00768287|Other Pre-specified|Number of Surgeries Requiring Blood Transfusions|Measure was assessed during Surgical Substudy.|During the surgical procedure||||Major surgeries|Major surgeries||Count of Units
2765768|NCT00768287|Other Pre-specified|Hemostasis Following Surgery|Surgeon assessment of hemostasis at 12 and 24 hours after surgery using the following descriptors: superior, adequate, or poorly controlled. Measure was assessed during Surgical Substudy.|12 and 24 hours after surgery||||Major surgeries|Major surgeries||Count of Units
2765769|NCT00768287|Other Pre-specified|Blood Loss During Surgery|Surgeon assessment of blood loss during the procedure using the following descriptors: less than expected, expected, or more than expected. Measure was assessed during Surgical Substudy.|During the surgical procedure|Major surgeries include synovectomy, knee or hip replacement, total tooth extraction, surgery for intracranial hemorrhage, radial head excision, arthrodesis, ankle surgery, abdominal surgery, prostatectomy, or surgery for major muscle bleed repair|||Major surgeries|Major surgeries||Count of Units
2765770|NCT00768287|Secondary|Annualized Bleed Rate|Measure was assessed during the Treatment Study|Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months|The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand.|||Bleeds/year||Inter-Quartile Range|Median
2765771|NCT00768287|Secondary|Volume of Distribution (Steady State)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||dL/kg||Standard Deviation|Mean
2765772|NCT00768287|Secondary|Clearance|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||dL/kg*hr||Standard Deviation|Mean
2765773|NCT00768287|Secondary|Mean Residence Time|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||hours||Standard Deviation|Mean
2765774|NCT00768287|Secondary|Incremental Recovery|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU/dL per IU/kg||Standard Deviation|Mean
2765775|NCT00768287|Secondary|Concentration (Max)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU/dL||Standard Deviation|Mean
2765776|NCT00768287|Secondary|Terminal Half-life|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||hours||Standard Deviation|Mean
2765777|NCT00768287|Secondary|Area Under the Curve (0-72 hr)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU*hr/dL||Standard Deviation|Mean
2765778|NCT00768287|Secondary|Area Under the Curve (0-inf)|Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours.|Pre-infusion to 72 hours following infusion||||IU*hr/dL||Standard Deviation|Mean
2765779|NCT00768287|Primary|Degree of Hemorrhage Control by Treatment Regimen|"Subject rating of bleed control within 6 hours of the time bleeding has stopped:~Excellent: a dramatic response with abrupt pain relief and clear reduction in joint or hemorrhage site size;~Good: pain relief or reduction in hemorrhage site size that may have required an additional infusion for resolution;~Fair: probable or slight beneficial response usually requiring one or more additional infusions for resolution;~Poor: no improvement or condition worsens."|Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months|The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand.|||Bleeding Episodes|Bleeding Episodes||Count of Units
2774147|NCT00711009|Secondary|Mean Change From Baseline in Calcium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2765780|NCT00768261|Secondary|Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change|The ADAS-Cog evaluates cognition and differentiates normal from impaired cognitive functioning. The total score is the summed number of errors in each task. The greater the impairment, the greater the score. We combined the dementia of the Alzheimer's type patients receiving all treatments together and grouped them into 3 subgroups according to the rates of change(roc) of their ADAS-Cog scores. To determine trends in hippocampal volume atrophy over time we compared the patients showing most negative ADAS-Cog rate of change (improving), patients with most positive ADAS-cog roc (worsening), patients with intermediate, near-zero ADAS-Cog roc (stable) .|two years|We combined the DAT patients who received any treatment (donepezil or combined) & used the annual roc in ADAS-Cog to equally separate them into 3 subgroups; improving (1/3 negative ADAS-Cog roc), stable (1/3 near-zero ADAS-Cog change) & worsening (1/3 positive ADAS-Cog change).|||(mm^3/year)||Standard Deviation|Mean
2765781|NCT00768261|Primary|Rate of Change of Hippocampal Volume Slope||2 years||||mm^3/year||Standard Deviation|Mean
2765782|NCT00768248|Secondary|Pain · 11-point Numeric Rating Scale of Pain Intensity · Usage of Baseline and Rescue Analgesics in Previous 24 Hours · Patient Global Impression of Change Scale||Day 8, Day 28, Month 12|Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.||||||
2765783|NCT00768248|Secondary|Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure||pre-intervention; and then 8 and 28 days post-intervention|Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.||||||
2765784|NCT00768248|Secondary|Emotional Functioning · Beck Depression Inventory||pre-intervention; and then day 28 and 365 post-intervention|Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.||||||
2765785|NCT00768248|Secondary|Physical Functioning · Brief Pain Inventory||pre-intervention, then days 1, 3, 8, 28, 84, and 365|Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.||||||
2765786|NCT00768248|Primary|Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement||Week 4|Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.||||||
2765787|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 90|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765788|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 30|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765789|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 12|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765790|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 7|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765791|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 5|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765792|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 3|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765793|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|30 days|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2766114|NCT00765375|Primary|Change in Mean Lesion Count From Baseline at 90 Days|To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)|Baseline and 90 days|All subjects completing Day 90 visit|||Lesions||Standard Deviation|Mean
2765794|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|12 days|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765795|NCT00768222|Primary|Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)|Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar|30 days (+/- 5) post-operative|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
2765796|NCT00768144|Secondary|Progression-Free Survival|Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.|||weeks||95% Confidence Interval|Median
2765797|NCT00768144|Secondary|16-Week Progression-Free Survival|16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
2765798|NCT00768144|Primary|Overall Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
2765799|NCT00768118|Primary|The Magnitude of Change in Blood Lymphocyte NF-kB Level|The target accrual goal is 15 subjects. It is hoped that of those 15, at least 10 will be intervention compliant, and provide both planned blood samples. NF-kB levels will be measured using a supershift assay, which tests the specificity and level of NF-kB in the sample by measuring the optical density of a scan. With 10 patients, the mean difference in blood lymphocyte NF-kB level could be estimated to within 0.44 standard 7 deviations, with 80% confidence. That is reasonable precision and confidence level for a small pilot study, and should provide sufficiently precise estimates for use in planning a subsequent study.|15 days||||Optical Density unit||90% Confidence Interval|Mean
2765800|NCT00768066|Secondary|Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 Months post-catheterization||||percent change||95% Confidence Interval|Mean
2765801|NCT00768066|Secondary|Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.|Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months post-catheterization||||units on a scale||95% Confidence Interval|Mean
2765802|NCT00768066|Secondary|Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 months post-catheterization||||meters||95% Confidence Interval|Mean
2765803|NCT00768066|Secondary|Number of Deaths||12-months post-catheterization||||participants|||Number
2765804|NCT00768066|Secondary|Ectopic Tissue Formation.||12 months post-catheterization||||participants|||Number
2765805|NCT00768066|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.||12 months post-catheterization||||participants|||Number
2765806|NCT00768066|Secondary|Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization||||ng/mL||95% Confidence Interval|Mean
2765807|NCT00768066|Secondary|Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization||||ng/mL||95% Confidence Interval|Mean
2765808|NCT00768066|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||one month post-catheterization||||participants|||Number
2766190|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2765809|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12|American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765810|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12|American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765811|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12|American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765812|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12|American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient's Global Assessment and Physician's Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765813|NCT00768053|Secondary|Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2|Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Baseline up to Week 12|All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration.|||participants|||Number
2765814|NCT00768053|Secondary|Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765815|NCT00768053|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765816|NCT00768053|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765817|NCT00768053|Secondary|Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2766005|NCT00766415|Primary|Induced Sputum: Neutrophils Count (%)|Change in Induced sputum Neutrophils count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2765818|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||percentage of participants|||Number
2765819|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||percentage of participants|||Number
2765820|NCT00768053|Secondary|Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.|Week 4, Week 12|All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||scores on a scale|||Number
2765821|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||percentage of participants|||Number
2765822|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||percentage of participants|||Number
2765823|NCT00768053|Secondary|Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.|Week 4, Week 12|All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||scores on a scale|||Number
2765824|NCT00768053|Secondary|Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12|EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2765825|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 12|All injected subjects population|||standardized response mean|||Number
2765826|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 4|All injected subjects population|||standardized response mean|||Number
2765827|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average|"Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question in general, how would you rate your health over the last 2 to 3 weeks; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85)."|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.|||correlation coefficient||95% Confidence Interval|Number
2765828|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12|"PGA of health status is a single-item participant rated response to the question in general, how would you rate your health over the last 2 to 3 weeks; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85)."|Week 12|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
2765829|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status|"PGA of health status is a single-item participant rated response to the question in general, how would you rate your health over the last 2 to 3 weeks; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85)."|Baseline, Week 4|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
2765830|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.|||correlation coefficient||95% Confidence Interval|Number
2765831|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Week 12|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
2765832|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Week 4|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
2765833|NCT00768053|Primary|Simplicity: Time for Completion of the EULAR-RAID Questionnaire|EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).|Baseline up to Week 12|All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping)|||minutes||Standard Deviation|Mean
2765834|NCT00768053|Primary|Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score|EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).|Screening, baseline|All injected subjects population: received at least 1 dose of study treatment (same as Safety population).|||intraclass correlation coefficient||95% Confidence Interval|Number
2765835|NCT00768040|Primary|Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment|The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor|Baseline to week 12|This study was terminated early due to low recruitment of patients.|||μm||Standard Error|Least Squares Mean
2765836|NCT00767819|Secondary|Percentage of Participants With Overall Survival (OS) at Week 16 (ITT)|Overall survival (OS) was defined as the time from the date of start of treatment to death from any cause. If a patient was not known to have died (was alive), OS was censored at the date of the last contact, which was the date of Visit 6 (Week 16) for the core phase and the last available visit for the follow-up phase. OS was explored by using the Kaplan-Meier method. One death occurred in Arm 3 after Week 16.|Baseline up to 16 weeks||||percentage of participants|||Number
2765837|NCT00767819|Secondary|Time to Progression (TTP) (ITT)|Time to progression (TTP) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from underlying disease. If a patient had not had an event, TTP was censored at the date of the last adequate tumor assessment, which was the date of Visit 6 (Week 16) for the core phase and the last available tumor assessment for the follow-up phase. TTP was explored by using the Kaplan-Meier method.|Baseline up to 16 weeks||||days||95% Confidence Interval|Median
2765838|NCT00767819|Secondary|Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks|Progression-free Survival (PFS) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from any cause. If a patient had not had an event, PFS was censored at the date of the last adequate tumor assessment at week 16|16 weeks||||percentage of participants|||Number
2765839|NCT00767819|Secondary|Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks.|Duration of response (CR, PR or SD) applied only to those patients whose best overall response was CR, PR or SD based on local radiologic assessments and was defined as the time from start of treatment to progression or death from underlying disease. Patients not experiencing progression or death at 16 weeks were censored with the date of their last tumor assessment. Duration of response was explored using the Kaplan-Meier method.|Baseline up to 16 weeks||||percentage of participants|||Number
2765840|NCT00767819|Secondary|Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT)|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions).|Baseline up to approximately 16 weeks||||percentage of participants|||Number
2765841|NCT00767819|Primary|Best Overall Response Rates by Week 16 (ITT)|"The best overall response is the best response recorded from treatment start until disease progression/recurrence (both measurement and confirmation criteria). Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions): Complete Response (CR)=at least two determinations of CR 4 weeks apart before progression, Partial Response (PR)=at least two determinations of CR 4 weeks apart before progression (and not qualifying for a CR), Stable Disease (SD)=at least one SD assessment >6 weeks after start of treatment and Progressive Disease (PD)=Progression or death due to underlying cancer ≤16 weeks after start of treatment. PD without radiologic evidence were classified as progression only, when clear evidence of clinical deterioration was available and patient discontinued due to disease progression. Unknown (UNK) = all other cases."|Baseline up to 16 weeks||||percentage of participants|||Number
2765842|NCT00767806|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale|The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.|baseline through 12 weeks|All randomized participants.|||participants|||Number
2765843|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Pulse Rate|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||beats per minute||Standard Error|Least Squares Mean
2765844|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||kilogram||Standard Error|Least Squares Mean
2765845|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Blood Pressure|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||millimeter mercury||Standard Error|Least Squares Mean
2765846|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Total Protein|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Gram/Liter||Standard Error|Least Squares Mean
2765847|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Creatinine|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Micromole/Liter||Standard Error|Least Squares Mean
2765848|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Units/Liter||Standard Error|Least Squares Mean
2765849|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|"All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing.~endpoints."|||Units/Liter||Standard Error|Least Squares Mean
2765850|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Units/Liter||Standard Error|Least Squares Mean
2765851|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Albumin|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Gram/Liter||Standard Deviation|Least Squares Mean
2765854|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism~Presenteeism~Work productivity loss~Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment."|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.|||units on a scale||Standard Deviation|Mean
2765855|NCT00767806|Secondary|Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension|Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
2765856|NCT00767806|Secondary|Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
2765857|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
2765858|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
2765859|NCT00767806|Secondary|Patient's Global Impression of Improvement (PGI-I) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
2765860|NCT00767806|Secondary|Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
2765861|NCT00767806|Secondary|Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution|The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.|12 weeks|All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.|||participants|||Number
2765862|NCT00767806|Secondary|Number of Sustained Responders at 12 Week Endpoint|Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
2765899|NCT00767325|Secondary|Number of Participants With Adverse Events (AEs) of Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Infusion reaction: acute=1 hour or less after start of dosing; periinfusional=24 hours or less after start of dosing.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.|||Participants|||Number
2765863|NCT00767806|Secondary|Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
2765864|NCT00767806|Secondary|Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
2765865|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
2765866|NCT00767806|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
2765867|NCT00767806|Primary|Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2765868|NCT00767767|Primary|GSR Trial 1|Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)|First Trial, for up to 1 day||||units on a scale||Standard Deviation|Mean
2765869|NCT00767676|Primary|Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale|"To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]~No statistical analyses were performed."|7 weeks|Per protocol|||participants|||Number
2765870|NCT00767624|Secondary|Percentage of Participants in Insomnia Remission|Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.|16 weeks||||percentage of particpants in arm|||Number
2765871|NCT00767624|Primary|Percent of Participants With Depression Remission|"Depression remission was defined if both a and b below are satisfied~absence of both depressed mood and anhedonia for at least three consecutive weeks~no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks"|16 weeks||||percentage of participants in arm|||Number
2765872|NCT00767572|Primary|Pre-post Change in Brachial Artery Reactivity|Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.|Baseline, 12 weeks|12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.|||mm||Standard Deviation|Mean
2765873|NCT00767520|Secondary|Number of Participants With Abnormalities in Electrocardiograms||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||2013-05-31|05/2013||||
2765874|NCT00767520|Secondary|Number of Participants With Abnormalities in Vital Signs||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||2013-05-31|05/2013||||
2765875|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)|Grade (GR)1= mild, GR2= moderate, GR3= severe, GR4= life threatening. Ranges are provided by the local laboratory and may vary according to sex and age. Phosphorous, GR1:<LLN 2.5 mg/dL, GR2:<2.5-2.0 mg/dL, GR3: 1.0-<2.0 mg/dL; Low sodium,GR1:<LLN 130mmol/L, GR3:120-<130 mmol/L; High Magnesium, GR1 >ULN 3.0 mg/dL,GR 3:<0.3 0.8mg/dL; Uric acid, GR1:>ULN 10 mg/dL, GR4:>10 mg/dL; Low potassium, GR1:<LLN 3.0mmol/L,GR3:<3.0 2.5mmol/L; High potassium, GR1:>ULN-5.5 mmol/L, GR2:>5.5-6.0 mmol/L; Bicarbonate, GR1:<LLN-16 mmol/L; GR2:<16 - 11 mmol/L; Hig sodium, GR1:>ULN-150 mmol/L,GR2:>150-155 mmol/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
2765876|NCT00767520|Primary|Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.|||participants|||Number
2765877|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)|Grade (GR) 1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening). Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, GR 1: >ULN-2.5 x ULN (upper limit of normal), GR 2: >2.5-5.0 x ULN, GR 3: 5.0-20.0 x ULN; Low calcium, GR 1: <LLN - 8.0 mg/dL, GR 2: <8.0-7.0 mg/dL, GR 4:<6.0 mg/dL; High calcium, GR 1:>ULN - 11.5 mg/dL; bilirubin, GR 1: >ULN-1.5 x ULN,GR 3: >3-10 x ULN; Creatinine, GR1:>ULN-1.5 x ULN, GR2: >1.5-3.0 x ULN; Albumin, GR1:<LLN-3 g/dL,GR2:<3-2 g/dL.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
2765878|NCT00767520|Secondary|Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)|Abnormalities were graded per NCI-CTC, Version 3.0 criteria. Grade (GR)1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening. Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Granulocytes, GR 1;<LLN-1.5x 10^9/L, GR 2:<1.5-1.0x10^9/L, GR 3: <1.0 - 0.5x10^9/L, GR, 4: <0.5x10^9 /L; Hemoglobin, GR 1: <LLN-10.0 g/dL, GR 2: <10.0-8.0 g/dL, GR 3: <8.0-6.5 g/dL, GR, 4: <6.5g/dL; Platelets, GR 1: <LLN-75.0x10^9/L, GR 2: <75.0-50.0x10^9/L, GR 3: <50.0-25.0x10^9/L; Leukocytes, GR 1: <LLN-3.0x10^9/L, GR 2: <3.0-2.0x10^9/L, GR 4: <1.0x10^9/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
2765879|NCT00767520|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade (GR)1 = mild, GR 2 = moderate, GR 3=severe, GR 4=life threatening, GR 5=death.|From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
2765880|NCT00767520|Secondary|Changes in Markers of Bone Lysis in Participants With Bone Metastasis|Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.|Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||2013-05-31|05/2013||||
2765881|NCT00767520|Secondary|Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis|"Pain intensity evaluated by administration of the Brief Pain Inventory - Short Form (BPI-sf). The BPI-sf is a psychometrically-validated instrument which measures both pain severity and functional interference caused by pain using an 11-point numerical rating scale. Severity of pain at its worst, least and on average in the last 24 hours, and right now (ie, at the time the questionnaire is being filled out) is recorded using anchors of no pain = 0 and pain as bad as you can imagine = 10."|Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||2013-05-31|05/2013||||
2765882|NCT00767520|Secondary|Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Duration of response is defined as the time from date that measurement criteria are first met for PR or CR until first date of documented PD or death. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.||2013-05-31|05/2013||||
2765883|NCT00767520|Secondary|Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Time to response is defined as time from first dose of study therapy until measurement criteria are first met for PR or CR (whichever is recorded first). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer||2013-05-31|05/2013||||
2765884|NCT00767520|Secondary|Participants With Freedom-From-Progression (FFP) at 6 Months|FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.|at 6 months||2013-05-31|05/2013||||
2765895|NCT00767455|Primary|Presence of Cumulative Irritation|Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).|22 days|Per protocol|||units on a scale|||Number
2765885|NCT00767520|Secondary|Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Response= Proportion of response-evaluable participants whose best response is CR or PR. Confidence intervals was computed using the Clopper-Pearson method. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks)|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||percentage of participants||95% Confidence Interval|Number
2765886|NCT00767520|Secondary|Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months|CB = participants whose best response is CR, PR, or stable disease(SD). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value). Confidence interval computed by Clopper-Pearson method.|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||percentage of participants||95% Confidence Interval|Number
2765887|NCT00767520|Secondary|Number of Participants With Best Overall Response|Complete response (CR) = Disappearance of all measurable and non-measurable lesions, and no new lesions; Partial response (PR) = Decrease ≥30% from baseline in sum of longest diameters (LD) of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value).|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||participants|||Number
2765888|NCT00767520|Primary|Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.|||weeks||95% Confidence Interval|Median
2765889|NCT00767507|Secondary|Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner||Through 7 days or hospital discharge, whichever was sooner||||patients|||Number
2765890|NCT00767507|Secondary|Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild||Randomization until start of CABG surgery|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.|||participants|||Number
2765891|NCT00767507|Secondary|Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding|Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units|Randomization through Hospital discharge|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.|||Patients|||Number
2765892|NCT00767507|Secondary|Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU|"This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:~Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)~Last sample during infusion~Following discontinuation of study drug infusion"|baseline until just prior to surgery (post infusion)||||percent of patients|||Number
2765893|NCT00767507|Primary|Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.|"This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.~Patients had multiple samples and all on-infusion samples had to be <240 PRU to meet the endpoint."|During study drug infusion up to 1-6 hours prior to surgery|"Based on available data from ITT population; ITT population (Cangrelor N = 93) / (Placebo N = 90).~Valid PRU results were not available during the infusion period for 15 patients (9 cangrelor and 6 placebo)."|||Percent of patients|||Number
2765894|NCT00767507|Primary|Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.|Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).|During study drug infusion up to 1-6 hours prior to surgery||||percentage of samples|Participants||Number
2765896|NCT00767364|Secondary|Serum Anti-rotavirus IgA Level Post-vaccination|Serum anti-rotavirus IgA level was measured post-vaccination in all subjects|6 months from the first vaccination date||||U/ml|||Number
2765897|NCT00767364|Primary|Safety and Tolerability of the Oral RotaTeq® Vaccine|Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.|12 months from the first vaccination date||||Individual Adverse Events|||Number
2765900|NCT00767325|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events(SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.|||Participants|||Number
2765901|NCT00767325|Secondary|Number of Early (Days 7 to 113) Global PDUS MCP 2-5 Scores or Global PDUS Component MCP 2-5 Scores Associated With an Acceptable Predictability of Clinical Response at Day 169, As Assessed by DAS28-CRP|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography; DAS=Disease Activity Score;CRP=C-reactive protein. Receiver Operator Characteristics (ROC) analysis assessed predicatability. ROC curve analyses performed; area under the curve of ≥0.7 was considered acceptable for prediction. Clinical response defined as: Clinically Meaningful Improvement=drop from baseline of ≥1.2 in DAS28-CRP; Remission=DAS28-CRP score <2.6; Low Disease Activity=≤3.2. PDUS scores: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH with ≤Gr 2 Doppler signal or minimal SH and Gr 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint rated 1-3, for a total possible score ranging from 8-24 (8*1, 8*3)for the 2 hands. Higher gr/score=more severe disease.|Days 1 to 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Scores|||Number
2765902|NCT00767325|Primary|Earliest Time Point at Which Improvement of Core Component of the Global PDUS in the MCP (2-5) Joints of Both Hands Was Assessed|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography. Time point at which early signs of Global PDUS improvement were observed=earliest time point for which 0 was not included in the 95% confidence interval for the mean changes from baseline in Global PDUS (MCP 2-5) score at that and all later time points. Total PDUS scores are independent of the presence and grade of joint effusion: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH, with ≤Gr 2 Doppler signal or minimal SH and grade 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher Gr/score=more severe disease.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Day|||Number
2765903|NCT00767325|Secondary|Mean Change From Baseline in Global PDUS MCP 2-5 Component Scores Over Time (LOCF Analysis)|PDUS=power Doppler ultrasonography; MCP=metacarpophalangeal; LOCF=last observation carried forward. PDUS was used to assess the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤ Grade 3 Doppler signal or minimal or 1-3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher grade/score=more severe disease. Change=score Day X-baseline score.|Days 7, 15, 29, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Units on a scale||Standard Error|Mean
2765904|NCT00767325|Primary|Mean Change From Baseline in Global Power Doppler Ultrasonography (PDUS) Score Assessing the Metacarpophalangeal (MCP) 2-5 Joints of Both Hands (LOCF Analysis)|LOCF=last observation carried forward. PDUS assessed the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. Total PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and Grade 2 Doppler signal; Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤Grade 3 Doppler signal or minimal or moderate synovial hypertrophy and Grade 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for 2 hands. Higher grade/score=more severe disease. Change=score Day x - baseline score.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Units on a scale||95% Confidence Interval|Mean
2765905|NCT00767104|Secondary|% Reduction in Total Lesion Count|.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.|12 weeks||||% reduction in total lesion count||95% Confidence Interval|Mean
2765906|NCT00767104|Primary|Total Lesion Count|The number of papules, pustules and cysts at Week 12.|12 weeks|Number of participants in each group|||lesions||95% Confidence Interval|Mean
2765941|NCT00766753|Primary|Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT)|Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.|up to 8 weeks|Participants at any dose level, through the first booster phase.|||Participants|||Count of Participants
2765907|NCT00767039|Secondary|Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.|Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.|NICU hospitalization, up to 42 weeks post menstrual age|All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.|||Subjects with BPD + Neonatal Deaths||90% Confidence Interval|Number
2765908|NCT00767039|Secondary|Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)|Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.|36 weeks post menstrual age|Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied.|||Surviving Subjects with BPD||90% Confidence Interval|Number
2765909|NCT00767039|Secondary|Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant|Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.|One hour following second surfactant dose at 12-24 hours after initial dose|The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.|||Percent change from baseline velocity||Standard Error|Mean
2765910|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20-Percent of O2||Standard Error|Mean
2765911|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20-Percent of O2||Standard Error|Mean
2765912|NCT00767039|Secondary|Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)|Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.|First hour after 2nd surfactant dose|Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.|||cc/min||Standard Error|Mean
2765913|NCT00767039|Secondary|Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)|Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.|Hemodynamically significant PDA at > 2 days|Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied|||Subjects||90% Confidence Interval|Number
2765914|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|72 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.|||Participants successfully extubated||90% Confidence Interval|Number
2765915|NCT00767039|Primary|Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20||Standard Error|Mean
2766191|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2765916|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|48 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.|||Participants successfully extubated||90% Confidence Interval|Number
2765917|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20||Standard Error|Mean
2765918|NCT00767000|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event||Entire study including 54-week study and 104-week extension||||percentage of participants|||Number
2765919|NCT00767000|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Entire study including 54-week study and 104-week extension|Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.|||percentage of participants|||Number
2765920|NCT00767000|Secondary|Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%||Weeks 54, 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158||||||
2765921|NCT00767000|Secondary|Percentage of Participants Who Achieve an HbA1c of <7.0%||Weeks 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158||||||
2765922|NCT00767000|Secondary|Change in the Fasting Plasma Glucose Level|Least squares mean change from baseline in fasting plasma glucose.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2765923|NCT00767000|Secondary|Change in the Two-hour Post Meal Glucose Level|Least squares mean change from baseline in 2-hour post meal glucose level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2765924|NCT00767000|Primary|Change in Hemoglobin A1c (HbA1c) Level|Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
2765925|NCT00766831|Secondary|Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug|"Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were I experienced a certain pain relief effect during the administration of the drug, I didn't wake up due to pain while sleeping, It was more convenient because the number of administrations was reduced, I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain and other."|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Percentage of participants|||Number
2765926|NCT00766831|Secondary|Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug|Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.|Day 15|ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.|||Percentage of participants|||Number
2765927|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators|Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
2765928|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants|Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
2765929|NCT00766831|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score|The CGI-Improvement score evaluates how much the participant's condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
2765942|NCT00766675|Secondary|Number of Participants With Subject's Global Assessment|Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
2765930|NCT00766831|Secondary|Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score|The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
2765931|NCT00766831|Secondary|Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain|The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.|||Frequency of breakthrough pain drug||Standard Deviation|Mean
2765932|NCT00766831|Secondary|Participant's Pain Intensity|Participant's pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Units on a scale||Standard Deviation|Mean
2765933|NCT00766831|Secondary|Korean Brief Pain Inventory (K-BPI) Questionnaire Score|K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.|||Units on a scale||Standard Deviation|Mean
2765934|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain|"The Investigator evaluated sleep disturbance through the participant's answers to below question in yes or no response: 'Did you wake up because of unbearable pain this morning?'"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
2765935|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Frequency of Waking Up|The Investigator evaluated sleep disturbance through the participant's answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn't fall asleep at all] of waking up due to pain last night).|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.|||Participants|||Number
2765936|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Analgesic Administration|"The Investigator evaluated sleep disturbance through the participant's answers to below question in yes or no response: 'Did you need to take an analgesic for pain relief in order to go to sleep last night?'"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
2765937|NCT00766831|Primary|Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain|Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.|Day 15 or Early withdrawal|Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.|||Percentage of treatment response||95% Confidence Interval|Number
2765938|NCT00766753|Secondary|Overall Survival (OS)|Time interval from start of treatment until date of death.|Up to 102 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||months||90% Confidence Interval|Median
2765939|NCT00766753|Secondary|12-month- Progression Free Survival (PFS)|Number of patients with progression-free status lasting at least 12 months|Up to 12 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||participants|||Number
2765940|NCT00766753|Primary|Median Time To Progression|Median number of months until disease progression. Tumor size was assessed using magnetic resonance imaging (MRI) scans with contrast enhancement to detect change from baseline.|At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||months||Full Range|Median
2765943|NCT00766675|Secondary|Number of Participants With Physician Global Assessment|The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
2765944|NCT00766675|Secondary|Total Fibromyalgia Impact Questionnaire (FIQ) Score|The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.|Baseline and Day 56|"The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Units on a scale||Standard Deviation|Mean
2765945|NCT00766675|Secondary|Participant Assessment Sleep Questionnaire Score|"Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to How often during past 4 weeks did participant felt and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement."|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2765946|NCT00766675|Secondary|Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept|"The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was How long did it usually take for participant to fall asleep during the past 4 weeks and Q2 was On the average, how many hours did participant sleep each night during the past 4 weeks."|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Hours||Standard Deviation|Mean
2765947|NCT00766675|Secondary|Tender-Point Evaluation/ Myalgic Score|Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2765948|NCT00766675|Secondary|Number of Participants With Categorical Scores on Pain Relief Rating Scale|Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
2765949|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 56|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
2765950|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 28|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 28|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
2765951|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 14|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 14|Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
2765952|NCT00766649|Secondary|Change in Photoreceptor Outer Segment (PROS) Thickness as Measured by Optical Coherence Tomography at 24 Months as Compared to Baseline||Baseline and Month 24|||||||
2765953|NCT00766649|Secondary|Change in Drusen Volume as Measured by Optical Coherence Tomography (OCT) at 24 Months as Compared to Baseline||Baseline and Month 24|||||||
2765954|NCT00766649|Secondary|Change in Total Area of Drusen in the Fellow Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
2765955|NCT00766649|Secondary|Change in Total Area of Drusen in the Study Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
2765956|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24||||MPS DA/month||Standard Deviation|Mean
2765958|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the fellow eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline and Month 24||||Ratio|Participants|Standard Deviation|Mean
2765959|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline to Month 24||||Ratio|Participants|Standard Deviation|Mean
2765960|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the fellow eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
2765961|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
2765962|NCT00766649|Secondary|Number of Study Eyes With a 15 Letter Drop From Baseline at 24 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Month 24||||eyes|Participants||Number
2765963|NCT00766636|Primary|Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.|Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report|Following resection performed at time of surgery, day 36 of treatment +/- 5 days|The study was terminated early without enough patients to perform any analysis between the groups. Of the five registered, one withdrew prior to any treatment and the others either had disease progression or left prior to surgery with incomplete preoperative regimen.||||||
2765964|NCT00766597|Secondary|Change in Plasma HIV RNA PCR|Changes in HIV RNA (copies/mL) from baseline to Week 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2765965|NCT00766597|Secondary|Change in Polymerase Genome and Envelope Sequence|Number of subjects with changes in genotypic and phenotypic drug resistance to the OBT and to vicriviroc (envelope sequence) from baseline to Week 24 and/or virologic failure will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2765966|NCT00766597|Secondary|Change in CD4 Percent|Change in CD4 percent from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2765967|NCT00766597|Secondary|Change in CD4 Counts|Change in CD4 count from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2765968|NCT00766597|Secondary|Number of Participants With Changes in Co-receptor Tropism From Baseline|Among all patients enrolled in Step I, the prevalence of detectable coreceptor phenotype, R5 tropic, R5/X4 mixed and X4 tropic viruses will be evaluated. The extent to which coreceptor phenotype in Step I is associated with Step I CD4 cell count, HIV RNA, and age will be evaluated. The association of Step I coreceptor phenotype and nadir CD4, HIV subtype, number of ART regimens, and years of ART will be evaluated. At the time of virologic failure, the extent of change from Step I and/or baseline R5 tropic virus to R5/X4 mixed or to X4 tropic virus as detected by the TrofileTM assay will be evaluated.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2765969|NCT00766597|Secondary|Number of Participants Who Failed to Achieve =>1-log Drop From Baseline in HIV-1 Viral Load and HIV-1 Viral Load of =>400 Copies/mL (Virologic Failures)|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular). The primary definition of virologic success will require subjects to have achieved and maintained 1-log drops from baseline of HIV-1 RNA or HIV-1 RNA <400 copies/mL.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
2765970|NCT00766597|Primary|Number of Participants Who Failed to Meet PK Targets|For Stage I subjects who are enrolled in Step II, the average of the pre-dose and 24 hour post dose sample from the intensive PK evaluations of said subjects will be used as the estimate of Cmin. The whole cohort will fail the PK targets if the population target (median vicriviroc Cmin should be =>200 ng/mL) is not met, and that nearly all of subjects' Cmin failed to be > 100 ng/mL.|At Week 24|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II and who failed the PK targets. Outcome measure not analyzed since the PK targets were for the whole cohort, but the lone cohort opened was not fully enrolled due to early study termination.||||||
2765971|NCT00766597|Primary|Number of Participants With Adverse Events of Grade 3 or Higher Severity|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II|||participants|||Number
2765972|NCT00766597|Primary|Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination|The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules is to be determined by the Study Team. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR5-tropic virus who started treatment in Step II.|||participants|||Number
2765973|NCT00766532|Primary|Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy|intestinal calcium absorption|baseline and 6 weeks later|12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.|||percent calcium absorption||Standard Deviation|Mean
2765974|NCT00766506|Other Pre-specified|Number of Participants Facing Technical Failure of the Device|Technical failure was defined as malfunctioning or failure of device to work appropriately.|Baseline up to end of study treatment (Hour 72)|Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.|||Participants|||Number
2765975|NCT00766506|Secondary|Number of Participants Who Require Concomitant Non-opioid Analgesics|Non-opioid analgesics are non morphine like medications used to get relieve from pain.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
2765976|NCT00766506|Secondary|Number of Participants Who Require Concomitant Antiemetic Medication|Antiemetic medicines are the drugs which prevent vomiting.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
2765977|NCT00766506|Secondary|Number of Participants Who Require Rescue Medication|Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.|Baseline up to Hour 3|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
2765978|NCT00766506|Other Pre-specified|Time to Actual Discharge|The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.|When participant was actually discharged from ward care (assessed up to 258.5 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Hours||95% Confidence Interval|Median
2765979|NCT00766506|Secondary|Time to Fit For Discharge (FFD)|"Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a Yes or No basis. When all criteria were answered as Yes, participant was considered to be FFD."|When participant was FFD (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Hours||95% Confidence Interval|Median
2765980|NCT00766506|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|"The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early study withdrawal|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2765981|NCT00766506|Secondary|Nurse Ease of Care (EOC) Questionnaire Score|Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from 'not at all' (Score 0) to 'a very great deal' (score 5). The total score was calculated as the mean of the non-missing items for all the questions.|When participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Units on scale||95% Confidence Interval|Least Squares Mean
2765982|NCT00766506|Secondary|Pain Intensity Numerical Rating Scale (NRS)|Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant's pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.|Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Unit on Scale||Standard Deviation|Mean
2765983|NCT00766506|Primary|Participant's Evaluation of Mean Ability to Mobilize After Surgery|"The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from not at all (score 0) to a very great deal (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility)."|Hour 72 or early study withdrawal|The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Units on scale||Standard Deviation|Mean
2765984|NCT00766493|Secondary|Neurologic Events|Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).|30 days||||Participants|||Number
2765985|NCT00766493|Secondary|Access Site Complications|Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.|30 days||||Participants|||Number
2765986|NCT00766493|Secondary|Clinical Success|Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.|30 days||||Participants|||Number
2765987|NCT00766493|Secondary|Device Success|Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).|Post Procedure||||Participants|||Number
2765988|NCT00766493|Primary|Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure||30 days|EMBOLDEN subjects evaluable for the primary endpoint|||Participants|||Number
2765989|NCT00766467|Secondary|Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment|To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.|56 days|Grade 3 - 4 events at least possibly related to study treatment.|||number of incidents|||Number
2765990|NCT00766467|Secondary|Change From Baseline in Quality of Life at Days 22, 43 and 56|The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.|baseline, day 22, day 43, and day 56|Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.|||units on a scale||80% Confidence Interval|Median
2766192|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2765991|NCT00766467|Primary|Change From Baseline in Fatigue at Day 43|The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.|43 days|Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.|||units on a scale||80% Confidence Interval|Median
2765992|NCT00766415|Secondary|Adverse Event (AE)|Number of participants with an Adverse Event|1 month||||Participants|||Number
2765993|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
2765994|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score|Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
2765995|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
2765996|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score|Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
2765997|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Evening|Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||95% Confidence Interval|Mean
2765998|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Morning|Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||95% Confidence Interval|Mean
2765999|NCT00766415|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)|Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||95% Confidence Interval|Mean
2766000|NCT00766415|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage change||95% Confidence Interval|Mean
2766001|NCT00766415|Primary|Induced Sputum: Total Cells Count|Change in Induced sputum Total cells count from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||10^6/g||95% Confidence Interval|Mean
2766002|NCT00766415|Primary|Induced Sputum: Epithelial Cells Count (%)|Change in Induced sputum Epithelial cells count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766003|NCT00766415|Primary|Induced Sputum: Lymphocytes Count (%)|Change in Induced sputum Lymphocytes count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766004|NCT00766415|Primary|Induced Sputum: Macrophages Count (%)|Change in Induced sputum Macrophages count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766193|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2766006|NCT00766415|Primary|Induced Sputum: Eosinophil Count (%)|Change in Induced sputum Eosinophil count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766007|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Total Cells Count|Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||10^6/g||95% Confidence Interval|Mean
2766008|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)|Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766009|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)|Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766010|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Macrophages Count (%)|Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766011|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Neutrophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766012|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Eosinophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
2766013|NCT00766415|Primary|Aggregated Pathology Score|Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
2766014|NCT00766376|Secondary|Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.|To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.|participants at three months||||Participants|||Number
2766015|NCT00766376|Primary|Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.|To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.|participants at three months||||Participants|||Number
2766016|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||h*ng/mL||Standard Deviation|Mean
2766017|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||hours||Standard Deviation|Mean
2766018|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||ng/mL||Standard Deviation|Mean
2766019|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||h*ng/mL||Standard Deviation|Mean
2766194|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766020|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||hours||Standard Deviation|Mean
2766021|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||ng/mL||Standard Deviation|Mean
2766022|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||h*ng/mL||Standard Deviation|Mean
2766023|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||hours||Standard Deviation|Mean
2766024|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||ng/mL||Standard Deviation|Mean
2766025|NCT00766363|Primary|Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)|Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]|Safety Population: All randomized subjects who ingested at least 1 dose of study drug.|||Participants|||Number
2766026|NCT00766116|Secondary|Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine||Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years||||Participants|||Count of Participants
2766027|NCT00766116|Primary|Number of Participants With Dose Limiting Toxicities|MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.|up to 28 days||||Participants|||Count of Participants
2766028|NCT00766090|Secondary|Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods|Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population|||participants|||Number
2766029|NCT00766090|Secondary|Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period|Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
2766030|NCT00766090|Secondary|Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2766031|NCT00766090|Secondary|Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period|Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2766032|NCT00766090|Secondary|24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period|A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.|Day 28 of the relevant treatment period (up to Study Day 112)|Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results|||Nanomoles per 24 hours||Geometric Coefficient of Variation|Geometric Mean
2766042|NCT00766038|Secondary|Processing Speed Index 1 Year After Injury|"Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function.~100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal"|1 year||||Processing speed index standardized scor||Inter-Quartile Range|Median
2766043|NCT00766038|Secondary|IGF-1 Levels.|Serum levels of Insulin-Like Growth Factor-1.|4 years||||ng/mL||Inter-Quartile Range|Median
2766033|NCT00766090|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population|||participants|||Number
2766034|NCT00766090|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.|Day 28 of the relevant treatment period (up to Study Day 112)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication|||Liters||Standard Error|Least Squares Mean
2766035|NCT00766051|Secondary|"A Priori H4: A Total Scale Score of Parents' Perception of Infant Easiness (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty. The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI. An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses a Likert scale. There are four questions, ranging from -3-3. The maximum score is 12, and the minimum score is -12.|Upon an infant's entry into the study, and again at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.|||Scores on Scale||Standard Deviation|Mean
2766036|NCT00766051|Secondary|"A Priori H3: A Total Score of the Parents' Global Confidence (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI. It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants. An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant. Global Confidence Measure uses a Likert scale. There are three questions, ranging from -3-3. The maximum score is 9, and the minimum score is -9.|Upon an infant's entry into the study, and at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.|||scores on scale||Standard Deviation|Mean
2766037|NCT00766051|Secondary|A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding.|Oral feeding percentage was based upon 150 kc/kg/day. Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg. This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy. As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %). Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.|The time frame was from Baseline until discharge (at or before 20 days).|The intervention group consisted of Four Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, and Two near term infants with Omphalocele. This outcome measured the correlation between the percentage of oral feedings and the percentage of High Frequesncy Heart Rate Variability.|||Percentage||Standard Deviation|Mean
2766038|NCT00766051|Primary|A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed.|This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first. Oral feeding percentages were based upon 150 kcal/kg/day. Feeding volumes and weights were taken directly from the nurses notes, and averaged daily. A two sample t-test was used to detect differences between the groups.|The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).|The intervention group and matched historical comparison group consisted of Four pairs of Extremely Preterm to Preterm infants with high risk factors, Three pairs of term or near term infants with Gastroschisis, Two pairs of infants term or near term with Omphalocele, and One pair of infants term age with Congenital Diaphragmatic Hernia.|||Days||Standard Deviation|Mean
2766039|NCT00766038|Secondary|Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema.|Rates of diabetes mellitus, arthralgias, or peripheral edema between rhGH treatment and placebo.|4 years||||Participants|||Count of Participants
2766040|NCT00766038|Secondary|IGF-1 Levels|Serum IGF-1 levels at baseline for both treatment groups was correlated with the Processing Speed Index recorded at baseline, using Pearson's correlation coefficient. Perason's correlation coefficient is a measure of the linear correlation between two variables X and Y. It has a value between +1 and −1, where 1 is total positive linear correlation, 0 is no linear correlation, and −1 is total negative linear correlation.|Baseline||||Pearson's correlation coefficient|||Number
2766041|NCT00766038|Secondary|GH Response to L-arginine Stimulation at Baseline|Measurement of serum GH levels over 90 minutes after administration of L-arginine|1 day||||ng/mL||Inter-Quartile Range|Median
2772187|NCT00724815|Secondary|Photophobia Free at Two Hours|Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
2766044|NCT00766038|Primary|Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index|"Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function.~100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal"|6 months||||Processing speed index standardized scor||Inter-Quartile Range|Median
2766045|NCT00765999|Primary|Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)|An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).|Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.|The analysis population consisted of participants in the Enrolled Population who received at least 1 dose of the open-label investigational product. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included in both the IBS-C and CC Safety Populations, leading to an analyzed population of 1555.|||Participants|||Count of Participants
2766046|NCT00765947|Secondary|Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment||24 weeks|||||||
2766047|NCT00765947|Secondary|Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]|Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).|24 weeks||||Percentage of Participants|||Number
2766048|NCT00765947|Secondary|Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]||Baseline and Week 24|Full analysis set|||mm Hg||Standard Deviation|Mean
2766049|NCT00765947|Secondary|Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks||||Percentage of Participants|||Number
2766050|NCT00765947|Primary|Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|Full analysis set|||Percentage of participants|||Number
2766051|NCT00765895|Primary|Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits|A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.|at end of treatment, 15 weeks from baseline assessment|intention to treat|||participants||95% Confidence Interval|Number
2766052|NCT00765882|Secondary|12-Week Constipation Severity|"Constipation severity was based on a 5-point ordinal scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 11 additional patients who dropped out prior to finishing 1 week of the trial were excluded from the Constipation Severity endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2766053|NCT00765882|Secondary|12-Week Bloating|"Bloating was based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 1 additional patient without a baseline Bloating score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2766054|NCT00765882|Secondary|12-Week Abdominal Discomfort|"Abdominal discomfort is based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. 1 additional patient without a baseline Abdominal Discomfort score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2766055|NCT00765882|Secondary|12-Week Severity of Straining|"Straining is measured on a 5-point scale, where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 Patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2766070|NCT00765817|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
2766056|NCT00765882|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2766057|NCT00765882|Secondary|12-Week Spontaneous Bowel Movement (SBM) Frequency Rate|A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||SBM per week||Standard Error|Least Squares Mean
2766058|NCT00765882|Secondary|12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||CSBM per week||Standard Error|Least Squares Mean
2766059|NCT00765882|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.~A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2766060|NCT00765843|Primary|Heel Pain|Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.|baseline, one month and three months||||score on a survey||Standard Deviation|Mean
2766061|NCT00765817|Secondary|Percentage of Subjects Experiencing Minor Hypoglycemia|Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set|||percentage|||Number
2766062|NCT00765817|Secondary|Minor Hypoglycemia Rate Per Year|Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set|||events per subject per year||Standard Deviation|Mean
2766063|NCT00765817|Secondary|Change in Diastolic Blood Pressure (DBP)|Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmHg||Standard Error|Least Squares Mean
2766064|NCT00765817|Secondary|Change in Systolic Blood Pressure (SBP)|Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmHg||Standard Error|Least Squares Mean
2766065|NCT00765817|Secondary|Change in Daily Insulin Dose (on a Per Body Weight Basis)|Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||insulin units per kg (U/kg)||Standard Error|Least Squares Mean
2766066|NCT00765817|Secondary|Change in Daily Insulin Dose|Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||insulin units (U)||Standard Error|Least Squares Mean
2766067|NCT00765817|Secondary|Change in Waist Circumference|Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||cm||Standard Error|Least Squares Mean
2766068|NCT00765817|Secondary|Change in Body Weight|Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||kg||Standard Error|Least Squares Mean
2766069|NCT00765817|Secondary|Change in Triglycerides|Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)|baseline and 30 weeks|Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
2766102|NCT00765388|Secondary|Changes in Skin Compared to Before Study|The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product|4 weeks|ITT population|||Participants|||Number
2766071|NCT00765817|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
2766072|NCT00765817|Secondary|Change in Total Cholesterol|Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
2766073|NCT00765817|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
2766074|NCT00765817|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
2766075|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.|||percentage|||Number
2766076|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.|||percentage|||Number
2766077|NCT00765817|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.|baseline and 30 weeks|Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||percentage of hemoglobin||Standard Error|Least Squares Mean
2766078|NCT00765765|Primary|Tumor Response Rate|Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.|3 years|The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.||||||
2766079|NCT00765765|Secondary|Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
2766080|NCT00765765|Secondary|Effects of Hydroxychloroquine on Autophagy||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
2766081|NCT00765765|Secondary|Pharmacodynamic Markers for Autophagy Detection||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
2766082|NCT00765765|Secondary|Survival Time||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
2766083|NCT00765765|Secondary|Time to Progressive Disease||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
2766084|NCT00765765|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
2766085|NCT00765726|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.|Month 24 or early withdrawal|Safety analysis population included all enrolled participants who had taken at least 1 dose of the study medication.|||Percentage of participants||95% Confidence Interval|Number
2766086|NCT00765674|Secondary|Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)|Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
2766103|NCT00765388|Secondary|Bag Twisting During Night|The patient was asked if he/she noticed whether the bag twisted during night|4 weeks|ITT population|||Participants|||Number
2766087|NCT00765674|Secondary|Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)|Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|End of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||Percentage of patients|||Number
2766088|NCT00765674|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
2766089|NCT00765674|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
2766090|NCT00765661|Secondary|Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.|"To evaluate the efficacy and safety of LCP-Tacro compared to Prograf in the first 12 months after kidney transplantation.~Efficacy was assessed by monitoring biopsy-proven acute rejection (BPAR) according to the Banff criteria, graft failure (defined by a patient starting dialysis for at least 30 days, nephrectomy, retransplantation, or death with a functioning graft), patient survival, and renal function based on serum creatinine and glomerular filtration rate (GFR), based on serum creatinine, serum urea nitrogen, and serum albumin."|12 months|All patients receiving at least one dose of study drug was included in the safety evaluation.|||participants|||Number
2766091|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.|||ng*hr/mL||Standard Deviation|Mean
2766092|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.|||ng/mL||Standard Deviation|Mean
2766093|NCT00765661|Primary|Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.|Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation|14 days||||percentage of patients|||Number
2766094|NCT00765648|Secondary|Transition Time to Oral Medication|The median transition time (in hours) to oral medication|6 hours|these are the correct participant numbers for this secondary analysis|||hours||Inter-Quartile Range|Median
2766095|NCT00765648|Secondary|Subjects Requiring the Use of Intravenous Rescue Medications|The percent of subjects requiring the use of intravenous rescue medications|6 hours||||percentage of participants|||Number
2766096|NCT00765648|Secondary|Treatment Failure|Treatment failure is defined as admission to the hospital or observation unit for BP management|6 hours|these are the correct participant numbers for this secondary analysis|||percentage of participants|||Number
2766097|NCT00765648|Secondary|Emergency Department(ED)Time to Disposition Decision|Median number of hours from hospital admission until Emergency Department(ED)disposition|6 hours|these are the correct participant numbers for this secondary analysis|||hours||Inter-Quartile Range|Median
2766098|NCT00765648|Secondary|Average Number of Dose Titrations Within 30 Minutes|Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group|30 minutes||||number of titrations||Standard Deviation|Mean
2766099|NCT00765648|Primary|Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.|Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.|30 minutes after initiation of therapy|Intent to treat cohort.|||percentage of participants|||Number
2766100|NCT00765570|Secondary|Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.|Complete response (CR) = 100% tumor disappearance Partial response (PR) = > 50% reduction in size Stable disease (SD) = < 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = > 10% increase in size of tumor Unknown Status (UK)|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.||||participants|||Number
2766101|NCT00765570|Primary|Protocol Treatment Related Morbidity|Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.||||events|||Number
2766115|NCT00765362|Primary|Knee Society Scores Used as Success/Failure Criteria.|The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Percentage of Participants with Success|||Number
2766116|NCT00765362|Primary|Knee Society Function Score|The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Average Knee Function Score||Standard Deviation|Mean
2766117|NCT00765362|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Average Knee Rating Score||Standard Deviation|Mean
2766118|NCT00765336|Primary|Mean Percent Change From Screening in Sperm Concentration.||Baseline and 12 Weeks|The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.|||Percent change||Standard Deviation|Mean
2766119|NCT00765245|Other Pre-specified|Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes||up to two years|||||||
2766120|NCT00765245|Other Pre-specified|Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide||up to two years|||||||
2766121|NCT00765245|Secondary|Number of Patients With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. Toxicities present at baseline and continuing without change in grade are excluded when considering worst‐grade toxicity.|30 days after completing treatment, for up to 13 months|Total number of patients reported with any toxicity|||participants|||Number
2766122|NCT00765245|Secondary|Disease-free Survival at 2 Years|Disease-free survival is the estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method where death is an event, with censoring for non‐expired patients at last known date alive.|From on-treatment date to disease recurrence, up to 2 years||||years||95% Confidence Interval|Median
2766123|NCT00765245|Primary|Disease-free Survival at 1 Year|Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.|From on-treatment date to disease recurrence, up to 1 year||||years||95% Confidence Interval|Mean
2766124|NCT00765232|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery||||mg||Standard Deviation|Mean
2766125|NCT00765232|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery||||units on a scale||Standard Deviation|Mean
2766126|NCT00765206|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days||||pH scale||Full Range|Median
2766127|NCT00765193|Secondary|Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.||one year|||||||
2766128|NCT00765193|Primary|Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.||one year|From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.|||participants|||Number
2766129|NCT00765128|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery||||mg||Standard Deviation|Mean
2766130|NCT00765128|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery||||units on a scale||Standard Deviation|Mean
2766131|NCT00765102|Secondary|Kaplan Meier Estimates for Overall Survival|Overall survival is the time from initiation of therapy to death from any cause.|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
2766155|NCT00765076|Secondary|The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
2766132|NCT00765102|Secondary|Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator|"Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
2766133|NCT00765102|Secondary|Kaplan Meier Estimate for Duration of Response Assessed by the Investigator|"Duration of response is defined as the time from first response to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
2766134|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Response Assessed by the Investigator|"The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response).~Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
2766135|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Progression Assessed by the Investigator|"Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. Analysis was not performed due to early termination of the study.||||||
2766136|NCT00765102|Secondary|Total Volume of Distribution (Vz)|Total volume of distribution of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||L||Geometric Coefficient of Variation|Geometric Mean
2766137|NCT00765102|Secondary|Total Clearance (CL)|Total clearance of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2766138|NCT00765102|Secondary|Terminal Half-life (t1/2)|Terminal half-life of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||hr||Geometric Coefficient of Variation|Geometric Mean
2766139|NCT00765102|Secondary|Time to Maximum Observed Concentration (Tmax)|Time to maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||hr||Full Range|Median
2766140|NCT00765102|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2766141|NCT00765102|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2766142|NCT00765102|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.|up to 9 months|Safety population of participants who took at least one dose of drug.|||participants|||Number
2766184|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766143|NCT00765102|Primary|Count of Participant Best Overall Response As Assessed by the Investigator|"Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.~Stable Disease: Less than MR, but not PD~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia."|up to 8 months|Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.||||||
2766144|NCT00765076|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2766145|NCT00765076|Secondary|Number of Subjects Reporting Any AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2766146|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2766147|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2766148|NCT00765076|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
2766149|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2766150|NCT00765076|Secondary|Duration of Solicited Local AEs|Duration was defined as the number of days with any grade of local symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
2766151|NCT00765076|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2766152|NCT00765076|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
2766153|NCT00765076|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||fold increase||95% Confidence Interval|Geometric Mean
2766154|NCT00765076|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
2766185|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766156|NCT00765076|Secondary|Haemagglutinin Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.|At Day 0, 21, 42 and 180|The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2766157|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
2766158|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
2766159|NCT00765076|Primary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)|Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
2766160|NCT00765063|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2766161|NCT00765063|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Units on a scale||Standard Deviation|Mean
2766162|NCT00765063|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Participants|||Number
2766163|NCT00765063|Secondary|Time to First Amputation||Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Months||95% Confidence Interval|Median
2766164|NCT00765063|Secondary|Time to Intact Skin Healing|Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Months||95% Confidence Interval|Median
2766165|NCT00765063|Secondary|Number of Participants Who Underwent Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Participants|||Number
2766166|NCT00765063|Secondary|Number of Participants With Improved Ulcer Healing|Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Participants|||Number
2766167|NCT00765063|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.|Baseline through Week 24 (EOT) or ET|Intent to treat (ITT) population included all participants who were enrolled into the study.|||Participants|||Number
2766168|NCT00765063|Primary|Number of Trivial Hemorrhages|Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
2766186|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766169|NCT00765063|Primary|Number of Clinically Relevant Minor Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
2766170|NCT00765063|Primary|Number of Minor Hemorrhages|Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
2766171|NCT00765063|Primary|Number of Major Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
2766172|NCT00765063|Primary|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
2766173|NCT00765037|Primary|Survivorship of the Encore Reverse Shoulder Prosthesis|Number of subjects who completed all study visits through the 1 year visit.|1 year||||participants|||Number
2766174|NCT00764946|Primary|Number of Participants Who Discontinued Due to an Adverse Event|Numbers of participants who discontinued due to an adverse event were summarized by race.|Week 48||||Participants|||Number
2766175|NCT00764946|Primary|Number of Participants With One or More Adverse Events|Numbers of participants with one or more adverse events were summarized by race.|Week 48||||Participants|||Number
2766176|NCT00764946|Secondary|Number of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.|||participants|||Number
2766177|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count|Mean changes from baseline in CD4 cell counts were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."|||cells/mm^3||95% Confidence Interval|Mean
2766178|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in HIV RNA|Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."|||log10 copies/mL||95% Confidence Interval|Mean
2766179|NCT00764946|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.|||Participants|||Number
2766180|NCT00764946|Primary|Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.|Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.~The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values."|||Participants|||Number
2766181|NCT00764881|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766182|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766183|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766195|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766196|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766197|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766198|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766199|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766200|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766201|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766202|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766203|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766204|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766205|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766206|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766207|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766208|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766209|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766210|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766211|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766212|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766213|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766214|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766215|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766216|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766217|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766218|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2766219|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2766220|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766221|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766222|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766223|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766224|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766225|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766226|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766227|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766228|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2766229|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
2766230|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 2|Reference Period 2 is defined as Day 91 to 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2766231|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 1|Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
2774148|NCT00711009|Secondary|Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2766232|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766233|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766234|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Baseline|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766235|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766236|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766237|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766238|NCT00764881|Secondary|Vaginal Effects Evaluated by Vaginal pH at Cycle 6|Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Proportion of participants|||Number
2766239|NCT00764881|Secondary|Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766240|NCT00764881|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
2766241|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766242|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766243|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766244|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766245|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766246|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766247|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766248|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766249|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766250|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766251|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766252|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766253|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766254|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766255|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766256|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766257|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766258|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2773164|NCT00718315|Secondary|Percentage of Participants With Erythema|Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
2766259|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score|Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766260|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6|The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766261|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline|The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Baseline|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2766262|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766263|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6|Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766264|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline|Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766265|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score|Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766266|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766267|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766268|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Total Score|The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766269|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Cycle 6|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766270|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Baseline|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
2766271|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)|Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766272|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766273|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766292|NCT00764868|Secondary|Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 52 weeks|FAS|||Percent of participants|||Number
2766274|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)|Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766275|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6|Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766276|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline|Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766277|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)|Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766278|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6|Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766279|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline|Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766280|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)|Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2766281|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2766282|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
2766283|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)|Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2766284|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6|Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2766285|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline|Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
2766286|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)|Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2766287|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2766288|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
2766289|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|Per Protocol Set (PPS) includes those participants of the FAS without major protocol deviations affecting the primary variables|||scores on a scale||Standard Deviation|Mean
2766290|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2766291|NCT00764868|Secondary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and Up to 52 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2766293|NCT00764868|Primary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 52 weeks|Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.|||Units on a scale||Standard Deviation|Mean
2766294|NCT00764790|Secondary|Number of Subjects Reporting Rare Serious Events|Rare serious events have an occurrence rate of 1/300 (0.3%).|During the entire study (Day 0 until Month 6)||||Participants|||Count of Participants
2766295|NCT00764790|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders"|During the entire study (Day 0 until Month 6)||||Participants|||Count of Participants
2766296|NCT00764790|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During a 28-day follow-up period after vaccination||||Participants|||Count of Participants
2766297|NCT00764790|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2766298|NCT00764790|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2766299|NCT00764790|Secondary|Seroconversion Factor|"Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity|||fold increase||95% Confidence Interval|Mean
2766300|NCT00764790|Secondary|Number of Seroprotected Subjects|"A seroprotected subject is a subject with a serum anti-HA titer~≥ 1:40~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
2766301|NCT00764790|Primary|Number of Subjects Who Seroconverted|"Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
2766302|NCT00764790|Primary|Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains|"GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||titre||95% Confidence Interval|Geometric Mean
2766303|NCT00764751|Secondary|The Absolute Change in PASI (Psoriasis Area Severity Index)|"The following formula was used to calculate the PASI for each side of the body:~Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z~where: R = score for redness T = score for thickness S = score for scaliness E = score for extent~The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here."|From baseline to end of treatment (Day 28)||||units on a scale||Standard Deviation|Mean
2766304|NCT00764751|Secondary|Participants With at Least 50% Reduction in PASI (PASI 50)||From baseline (Day 0) to end of treatment (day 28)|All randomised participants have been included in the analysis.|||Participants|||Count of Participants
2766305|NCT00764751|Secondary|Participants With at Least 75% Reduction in PASI (PASI 75)||From baseline (Day 0) to end of treatment (Day 28)|Two participants withdrew from the LEO 19123 versus Dovonex® group at Week 2.|||Participants|||Count of Participants
2766306|NCT00764751|Secondary|Participant's Assessment of Treatment Preference||At end of treatment (Day 28)|All randomized participants have been included in the analysis. One participant withdrew and did therefore not give their preference.|||Participants|||Count of Participants
2766307|NCT00764751|Secondary|Participant's Overall Assessment of Treatment Response|"The participant assessed the treatment response by use of the 6-point scale below.~Worse Unchanged Slight improvement Moderate improvement Marked improvement Almost clear Cleared"|At end of treatment (Day 28)|All randomized participants have been included in the analysis. One participant withdrew and did therefore not give their assessment.|||Participants|||Count of Participants
2766308|NCT00764751|Secondary|"Participants With Controlled Disease According to the Investigator's Global Assessment of Disease Severity"|"For subjects with a baseline (Visit 1) severity of moderate or worse, controlled disease is defined as clear or almost clear according to the Investigator's global assessment of disease severity. For subjects with a baseline (Visit 1) severity of mild, controlled disease is defined as clear according to the Investigator's global assessment of disease severity."|At end of treatment (Day 28)||||Participants|||Count of Participants
2766376|NCT00764322|Secondary|Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes|The intrapatient change in median endoxifen levels were calculated between baseline and 4 months after the increase in dose of Tamoxifen from 20mg/day to 40 mg/day|Baseline and 4 months after dose increase|Analysis limited to only those subjects with the Poor Metabolizing (PM) genotype who were evaluable at baseline|||ng/mL||Inter-Quartile Range|Median
2766309|NCT00764751|Secondary|Investigator's Global Assessment of Disease Severity|"At all visits the (sub)investigator made a global assessment of the disease severity for psoriasis on the left and right side, respectively, of the body by use of the 6-point scale below. These assessments were to represent the average lesion severity on the left and right side, respectively. These assessments were to be based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.~Clear Almost clear Mild Moderate Severe Very severe"|At end of treatment (Day 28)||||Participants|||Count of Participants
2766310|NCT00764751|Primary|The Percentage Change in PASI (Psoriasis Area Severity Index)|"The following formula was used to calculate the PASI for each side of the body:~Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z~where: R = score for redness T = score for thickness S = score for scaliness E = score for extent~The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here."|From baseline (Day 0) to end of treatment (Day 28)||||percentage change in PASI||Standard Deviation|Mean
2766311|NCT00764699|Primary|The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity||Six months and 1 year|The PI left the institution suddenly and participant records stayed with the institution, so no analysis was able to be performed.||||||
2766312|NCT00764673|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|All subjects in the study were evaluated for adverse events.|||Events|||Number
2766313|NCT00764673|Primary|Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.|Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.|2-year|The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.|||participants|||Number
2766314|NCT00764673|Secondary|Oxford Knee Score|Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.|2-year|The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.|||Units on a scale||Standard Deviation|Mean
2766315|NCT00764673|Primary|Knee Society Function Score|The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.|2-year|The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.|||Average Knee Function Score||Standard Deviation|Mean
2766316|NCT00764673|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|The number of subjects who completed their 2 year visit.|||Average Knee Rating Score||Standard Deviation|Mean
2766317|NCT00764660|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 12 weeks|The APT population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2766318|NCT00764660|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 16 weeks|The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2766319|NCT00764660|Secondary|Change From Baseline in Mood VAS Score|"Participants were asked to answer the question: Over the past week, how did you feel? The 100 mm line of the VAS was anchored on the left by Extremely bad and on the right by Extremely good. Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome."|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2766320|NCT00764660|Secondary|Change From Baseline in Motivation VAS Score|"Participants were asked to answer the question: Over the past week, how motivated were you to stay alcohol abstinent? The 100 mm line of the VAS was anchored on the left by No motivation at all and on the right by Extremely motivated. Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome."|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2766321|NCT00764660|Secondary|Change From Baseline in Craving Visual Analog Scale (VAS) Score|"Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink? The 100 mm line of the VAS was anchored on the left by No desire at all and on the right by Extreme desire. Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome."|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2766322|NCT00764660|Secondary|Global Functioning: CGI - Therapeutic Effect|The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||Standard Deviation|Mean
2766323|NCT00764660|Secondary|Global Functioning: Clinical Global Impression (CGI) - Severity of Illness|The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||Standard Deviation|Mean
2766324|NCT00764660|Secondary|Percentage of Participants With Complete Abstinence|Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Participants|||Number
2766325|NCT00764660|Secondary|Percentage of Abstinent Days|Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2766326|NCT00764660|Secondary|Time to First Relapse Into Drinking|Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Days||Standard Deviation|Mean
2766327|NCT00764660|Secondary|Number of Lapses Into Any Drinking|An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Lapses||Standard Deviation|Mean
2766328|NCT00764660|Secondary|Number of Relapses Into Heavy Drinking|An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Relapses||Standard Deviation|Mean
2766329|NCT00764660|Secondary|Number of Drinks Per Drinking Day|The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with 'day' being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Drinks||95% Confidence Interval|Least Squares Mean
2766330|NCT00764660|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use.~A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol).~Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval."|12 weeks|The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2766331|NCT00764517|Secondary|Scientific Correlates|"Perform scientific correlates to determine if SCR treatment a) is associated with global and gene specific changes in transcription of mRNAs and MiRNAs b) is acting as an inhibitor of DNA methylation c) is activating or silencing specific genes or miRNAs.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis."|Baseline|Data not collected and the outcome will never be analyzed.||||||
2766332|NCT00764517|Secondary|Contribution (if Any) of DNA Methylation/Histone Deacetylation|"Determine the contribution (if any) of DNA methylation/histone deacetylation to disease progression and/or response to SCR combination chemotherapy.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis."|Up to 2 years|Data not collected and the outcome will never be analyzed.||||||
2766333|NCT00764517|Secondary|Event-free Survival|"Time from treatment start until disease progression, death, or discontinuation of treatment for adverse event (toxicity)~Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant."|Up to 5 years||||Months||95% Confidence Interval|Median
2766334|NCT00764517|Secondary|Progression-free Survival|"Time from treatment start until disease progression or death.~Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant."|Up to 5 years||||Months||95% Confidence Interval|Median
2766335|NCT00764517|Primary|Tolerability of Treatment|Tolerability is determined to be the percentage of patients who completed the full duration of treatment (all 6 cycles) regardless of adverse event status. % tolerability shows the rate of patients that tolerated the treatment for the full duration.|6 months||||percentage of participants||95% Confidence Interval|Number
2766434|NCT00763867|Other Pre-specified|MRI Aortic Distensibility|An increase in Aortic Distensibility is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||cm^2*dyne-1||Standard Deviation|Mean
2766336|NCT00764517|Primary|Toxicities as Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Toxicity is determined percentage of patients that experienced an adverse event (AE) grade 3 or higher during the time frame, assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade refers to the severity of the AE increasing from Grade 1 to 5. Generally, Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.|6 months||||percentage of participants||95% Confidence Interval|Number
2766337|NCT00764517|Primary|Objective Response Rate|ORR defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR). Assessed per the revised Cheson criteria. Response definitions per revised International Working Group Response Criteria. 95% confidence interval will be provided. Definitions: Complete response (CR) = disappearance of all evidence of disease; Partial response (PR) = regression of measurable disease and no new sites.|2 years||||percentage of participants||95% Confidence Interval|Number
2766338|NCT00764504|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.|||adverse events|||Number
2766339|NCT00764504|Primary|Radiographic Failures|Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.|Post-operative, 3-month, 6-month, 1-year, 2-year|Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.|||participants|||Number
2766340|NCT00764504|Primary|"Neer's Limited Goals"|To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
2766341|NCT00764504|Primary|Have Surgery Again?|Subject satisfaction: subject's willingness to have surgery performed again if necessary.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
2766342|NCT00764504|Primary|Subject Satisfaction With Surgery|Each subject had a chance to rate their satisfaction with surgery at each study interval.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
2766343|NCT00764504|Primary|Average Range of Motion|Physician's assessment of a subject's range of motion in degrees.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||Angle of Degrees of Shoulder Motion||Standard Deviation|Mean
2766344|NCT00764504|Primary|American Shoulder and Elbow Surgeons Shoulder Score|"The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:~[(10 - Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]"|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||Units on a scale||Standard Deviation|Mean
2766345|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766346|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766347|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766406|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766348|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766349|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766350|NCT00764478|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766351|NCT00764478|Secondary|Change From Baseline in PANSS Positive Subscale Score|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766352|NCT00764478|Secondary|Change From Baseline in PANSS Negative Subscale Score|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766353|NCT00764478|Secondary|Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766354|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score|The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
2766355|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score|The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
2766356|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score|The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
2766357|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Depression Score|The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2766358|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Mania Score|The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766359|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766360|NCT00764478|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7 and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2766361|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 2, Day 4, Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
2766362|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement.|||Percentage of participants|||Number
2766363|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
2766364|NCT00764478|Secondary|Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7 and Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766365|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Percentage of participants|||Number
2766407|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766366|NCT00764478|Secondary|Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766367|NCT00764478|Primary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
2766368|NCT00764465|Primary|AUC: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng•h/mL||90% Confidence Interval|Mean
2766369|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
2766370|NCT00764465|Secondary|Number of Participants Who Experienced an Adverse Event|"Safety/tolerability data collected included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~MVC 300mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with MVC 300mg BID~FPV 700mg/RTV 100 mg BID combined with MVC 300mg BID~FPV 1400mg/RTV 100mg QD combined with MVC 300mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004"|Day 0 through Day 49||||participants|||Number
2766371|NCT00764465|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
2766372|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens||||ng/mL||90% Confidence Interval|Mean
2766373|NCT00764361|Secondary|Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)||baseline, week 4, week 10, week 20|||||||
2766374|NCT00764361|Primary|Number of Participants Without Adverse Events|Participants were monitored for 20 weeks during the study.|every 2 weeks||||participants|||Number
2766375|NCT00764322|Secondary|Patient Understanding of Pharmacogenomics|To examine patients' beliefs about how hypothetical genotype information would affect their perceived recurrence risk and benefits of tamoxifen therapy, participants were given experimentally manipulated 6 vignettes to describe hypothetical tamoxifen treatment (no or yes) and hypothetical genotype (EM, IM or PM). For each vignette, participants gave their perceived recurrence risk (RR; 0-100%)|baseline|Of 377 patients who were eligible to complete the survey, 320 patients completed the survey and 57 returned incomplete surveys|||percent chance of recurrence||Full Range|Mean
2766408|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766377|NCT00764322|Secondary|CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate|Mean endoxifen levels by CYP2D6 genotype among African Americans. Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline.The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|baseline|Only participants who self-identified as African American were included in this analysis|||ng/ml||Full Range|Mean
2766378|NCT00764322|Secondary|Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy|If the key active tamoxifen metabolite, endoxifen, could be significantly increased by genotype-guided tamoxifen dosing in patients with intermediate CYP2D6 metabolism (by increasing tamoxifen dosing based on CYP2D6 genotype), then the study would be deemed feasible and the accrual expanded.|Baseline and 4 months after dose increase|This was based on the initial 119 subjects enrolled (based on initial sample size of 100) and of those, the 89 that completed 4 months of tamoxifen therapy|||ng/mL||Inter-Quartile Range|Median
2766379|NCT00764322|Secondary|Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer|"The doubling of tamoxifen dose is defined as unacceptable (i.e., not tolerable) if the prevalence of Pulmonary embolism (PE), Deep vein thrombosis (DVT), stroke, or endometrial cancer, either individually or in any combination, is greater than 2%."|Approximately ten months from registration to last follow-up|Incidence of unacceptable adverse events among all patients who completed study|||Participants|||Count of Participants
2766380|NCT00764322|Primary|Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes|Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|4 months|Baseline measurements are reported on all 353 subjects, while the 4 month levels are reported only for patients who completed 4 months of treatment|||ng/mL||Standard Deviation|Mean
2766381|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR)|GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||participants|||Number
2766382|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Hematology|Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||participants|||Number
2766383|NCT00764309|Primary|Reasons for Discontinuation of Study Treatment|"Participants who discontinued the study due to any AEs were recorded.~Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing."|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||Participants|||Number
2766384|NCT00764309|Primary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||Participants|||Number
2766385|NCT00763971|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.|Up to 7 weeks|Safety Population|||participants|||Number
2766386|NCT00763971|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 7 weeks|Safety Population defined as all subjects who took at least 1 dose of investigational product.|||Scores on a scale||Standard Deviation|Mean
2766387|NCT00763971|Secondary|Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2766409|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766388|NCT00763971|Secondary|Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline and up to 7 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
2766389|NCT00763971|Secondary|Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Deviation|Mean
2766390|NCT00763971|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
2766391|NCT00763971|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 7 weeks|FAS|||percentage of participants|||Number
2766392|NCT00763971|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and up to 7 weeks|Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.|||Scores on a scale||Standard Error|Least Squares Mean
2766393|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.|Number of participants with positive opiate urine sample at the 24 week follow-up.|24 weeks|All subjects were included in the analysis population as intent to treat.|||participants|||Number
2766394|NCT00763958|Secondary|Number of Participants Who Enroll in the Study.|To determine the number of participants who enroll in the study during the time of recruitment.|up to 24 months||||participants|||Number
2766395|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.|Number of participants with positive opiate urine samples at 12 weeks of treatment.|12 weeks|All subjects were included in the analysis population as intent to treat.|||participants|||Number
2766396|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766397|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766398|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766399|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766400|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766401|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766402|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766403|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766404|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766405|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766410|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766411|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766412|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766413|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766414|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766415|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
2766416|NCT00763919|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766417|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766418|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
2766419|NCT00763867|Other Pre-specified|Furosemide-Equivalent Dose||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
2766420|NCT00763867|Other Pre-specified|Galectin 3||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL||Standard Deviation|Mean
2766421|NCT00763867|Other Pre-specified|Cyclic Guanosine Monophosphate (cGMP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pmol/mL||Standard Deviation|Mean
2766422|NCT00763867|Other Pre-specified|Collagen Type I (CITP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2766423|NCT00763867|Other Pre-specified|High Sensitivity C-Reactive Protein||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2766424|NCT00763867|Other Pre-specified|Endothelin-1||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2766425|NCT00763867|Other Pre-specified|Procollagen III N-terminal Peptide||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2766426|NCT00763867|Other Pre-specified|High Sensitivity Troponin I||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2766427|NCT00763867|Other Pre-specified|Aldosterone||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2766428|NCT00763867|Other Pre-specified|N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2766429|NCT00763867|Other Pre-specified|Uric Acid||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2766430|NCT00763867|Other Pre-specified|Cystatin C||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2766431|NCT00763867|Other Pre-specified|Best Available Glomerular Filtration Rate (GFR)|Best available=local lab results when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min/1.73m^2||Standard Deviation|Mean
2766432|NCT00763867|Other Pre-specified|Best Available Creatinine|Best available=local lab results only when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2766433|NCT00763867|Other Pre-specified|ECHO Pulmonary Artery Systolic Pressure|A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mmHg||Standard Deviation|Mean
2766436|NCT00763867|Other Pre-specified|MRI Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Woods units||Standard Deviation|Mean
2766437|NCT00763867|Other Pre-specified|MRI Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Farads-1||Standard Deviation|Mean
2766438|NCT00763867|Other Pre-specified|ECHO Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Woods units||Standard Deviation|Mean
2766439|NCT00763867|Other Pre-specified|ECHO Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Farads-1||Standard Deviation|Mean
2766440|NCT00763867|Other Pre-specified|Lateral Filling Pressure|A decrease in lateral filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
2766441|NCT00763867|Other Pre-specified|Medial Filling Pressure|A decrease in medial filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
2766442|NCT00763867|Other Pre-specified|Lateral Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
2766443|NCT00763867|Other Pre-specified|Medial Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
2766444|NCT00763867|Other Pre-specified|Lateral Diastolic Elastance|A decrease in Lateral Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||(m/sec)/cc||Standard Deviation|Mean
2766445|NCT00763867|Other Pre-specified|Medial Diastolic Elastance|A decrease in Medial Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||(m/sec)/cc||Standard Deviation|Mean
2766446|NCT00763867|Other Pre-specified|Echocardiogram Left Ventricular Mass|A decrease in Left Ventricular Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm||Standard Deviation|Mean
2766447|NCT00763867|Other Pre-specified|MRI Left Ventricular Ejection Fraction (LVEF)|An increase in LVEF is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||percentage of volume||Standard Deviation|Mean
2766448|NCT00763867|Other Pre-specified|MRI Left Ventricular End Systolic Volume Index|An increase in Left Ventricular End Systolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/m^2||Standard Deviation|Mean
2766449|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume Index|An increase in Left Ventricular End Diastolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/m^2||Standard Deviation|Mean
2766450|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume|An increase in Left Ventricular End Diastolic Volume is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2766451|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass Index|A decrease in Left Ventricular Mass Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm/m^2||Standard Deviation|Mean
2766452|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass|A decrease in LV Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm||Standard Deviation|Mean
2766453|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire|The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2766454|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHFQ)|"The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.~Total score: 0 - 105 Physical subscore: 0 - 40 Emotional subscore: 0 - 25"|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2766455|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
2766456|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
2766457|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||minutes||Standard Deviation|Mean
2766458|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||minutes||Standard Deviation|Mean
2766459|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 minute walk distance|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||meters||Standard Deviation|Mean
2766460|NCT00763867|Secondary|Composite Score Reflective of Clinical Status|"Participants ranked sequentially with ranking stratified in one of three tiers based on:~Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.~Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.~Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)~The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)"|Measured at Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2766461|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 Minute Walk Distance|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||meters||Standard Deviation|Mean
2766462|NCT00763867|Secondary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
2766463|NCT00763867|Primary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
2766464|NCT00763815|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2766465|NCT00763815|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2766466|NCT00763815|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2766467|NCT00763815|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
2773165|NCT00718315|Secondary|Time to Appearance of Skin Rash|Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE|Days 0, 15, and 30|ITT Population|||Days||95% Confidence Interval|Median
2766468|NCT00763815|Secondary|Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2766469|NCT00763815|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2766470|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPI assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
2766471|NCT00763815|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2766472|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2766473|NCT00763815|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2766474|NCT00763750|Primary|Number of Patients Assessed for Toxicity According to CTC Version 3.0||Throughout the entire study until patient is removed from study an average of 6 weeks||||participants|||Number
2766475|NCT00763698|Primary|Left Ventricular Bipolar Pacing Capture Threshold (Volts)|The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.|3 months|This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the “Primary Pacing Capture Threshold Patient Cohort”.|||volts||Standard Deviation|Mean
2766476|NCT00763698|Primary|Percentage of Successful Left Ventricular Lead Implants|Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.|3 months|All patients with an implant or attempted implant were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2766477|NCT00763698|Primary|Freedom From Left Ventricular Lead-related Complications|A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.|3 months|Analysis was conducted on the 81 patients with a successful left ventricular lead implant.|||percent of participants||95% Confidence Interval|Number
2766478|NCT00763490|Secondary|Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)|"The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated.~Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea)."|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
2766479|NCT00763490|Secondary|Cumulative Incidence of Neutrophil and Platelet Engraftment|The failure to achieve a neutrophil count > 500/uL or a platelet count >30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure.|Day 35||||percentage of participants||95% Confidence Interval|Number
2766480|NCT00763490|Secondary|Percentage of Patients Alive at the End of the Trial|Event Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years).|5 Years||||percentage of patients||95% Confidence Interval|Number
2766481|NCT00763490|Primary|Percentage of Participants Alive at 1 Year After Transplant|One-year survival rate after transplant|1 year||||percentage of participants||95% Confidence Interval|Number
2766482|NCT00763451|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks|"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||participants|||Number
2766483|NCT00763451|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
2766484|NCT00763451|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|"mITT population. The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
2766485|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
2766486|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
2766487|NCT00763451|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||kilogram||Standard Error|Least Squares Mean
2766488|NCT00763451|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.The Placebo (Two-step Titration)andPlacebo (One-step Titration)Arms/Groups were combined as pre-specified in the study protocol"|||mmol/L||Standard Error|Least Squares Mean
2766489|NCT00763451|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.~The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2766490|NCT00763412|Secondary|C-Peptide||2 year||||pg/ml||Full Range|Mean
2766491|NCT00763412|Secondary|FEV 1|% of lung function|2 year/end of study||||% lung function||Full Range|Mean
2766492|NCT00763412|Secondary|Tanner Stage|Puberty scale measuring 1-5, 1 being least development, 5 being most development.|2 year/end of study||||units on a scale||Full Range|Mean
2766493|NCT00763412|Secondary|Wt Z Score||2 year/end of study||||Z score||Full Range|Mean
2766494|NCT00763412|Secondary|Inflammatory Markers||2 year/end of study||||pg/ml||Full Range|Mean
2766495|NCT00763412|Secondary|Glucose Tolerance|We completed the OGTT at the 2 year/end of study visit.|2-year||||mg/dl||Full Range|Mean
2766496|NCT00763412|Primary|CRP||2 year/end of study||||mg/L||Full Range|Mean
2766497|NCT00763412|Primary|Body Composition|Reporting % of Fat and Lean body mass|2 year/end of study||||% body mass||Full Range|Mean
2766498|NCT00763412|Primary|BMI||2 year/end of study||||Kg/m^2||Full Range|Mean
2766499|NCT00763386|Secondary|Return to Function (RtF) Via Knee Society Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|6 Weeks to 2 Years Post-op, based on on the intervals listed||||units on a scale||Standard Deviation|Mean
2766500|NCT00763386|Primary|Postoperative Range of Motion (ROM)|Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.|6 Weeks to 2 Years Post-op, based on on the intervals listed|Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval.|||degrees||Standard Deviation|Mean
2766501|NCT00763360|Secondary|Corneal Clarity|Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.|2 weeks|Data from subjects for whom this evaluation was not performed is not included in this analysis.|||units on a scale|||Number
2766502|NCT00763360|Secondary|Change in Corneal Thickness|Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.|1 month|Subjects that did not have both baseline and 1 month values were not included in this analysis.|||millimeters||Standard Deviation|Median
2766503|NCT00763360|Primary|Investigator Reported Space Maintenance|"Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: Full Chamber Maintained, Working Space Maintained, Shallow, Flat. Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion."|During surgical procedure||||participants|||Number
2766504|NCT00763360|Primary|Endothelial Cell Count Change From Baseline|Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.|one month|Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.|||Percent change from baseline||Standard Deviation|Mean
2766505|NCT00763321|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.|||scores on a scale||Standard Error|Least Squares Mean
2766506|NCT00763321|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).|||scores on a scale||Standard Error|Least Squares Mean
2766507|NCT00763282|Secondary|Mean Number of Skin-related Admissions|Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.|Discharge to end of study (6 months)|Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)|||admissions/participant||Standard Deviation|Mean
2773868|NCT00712335|Primary|Sputum Neutrophil Percentages|Week 24 sputum neutrophil percentages were measured in active treatment groups.|24 weeks|We will be using intention-to-treat and per protocol for analysis.|||percentage of neutrophils||Standard Deviation|Mean
2766508|NCT00763282|Primary|Skin Status|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|Admission (Baseline), 3 months, 6 months||||participants|||Number
2766509|NCT00763282|Primary|Any Skin Worsening|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|6 months||||participants|||Number
2766510|NCT00763282|Primary|Skin Behavior Change|"Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months||||% Change||Standard Deviation|Mean
2766511|NCT00763282|Primary|Percent of Possible Self-Reported Skin Care Behaviors|"Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months||||% of Possible Self-Reported Behaviors||Standard Deviation|Mean
2766512|NCT00763269|Secondary|Air Blast Hypersensitivity (8 Week)|"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth."|8 weeks||||units on a scale||Standard Deviation|Mean
2766513|NCT00763269|Secondary|Air Blast Hypersensitivity (4 Week)|"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth."|4 weeks||||units on a scale||Standard Deviation|Mean
2766514|NCT00763269|Primary|Hypersensitivity Tactile (Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|8 weeks||||Units on a scale||Standard Deviation|Mean
2766515|NCT00763269|Primary|Hypersensitivity Tactile(Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|4 weeks||||units on a scale||Standard Deviation|Mean
2766516|NCT00763256|Primary|P. Gingivalis|Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.|12 months||||Pg/ng DNA||Inter-Quartile Range|Median
2766517|NCT00763256|Primary|Gingivitis Score (GI)|"Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|12 months||||Units on a scale||Standard Deviation|Mean
2766518|NCT00763256|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||nmol/L||Standard Deviation|Mean
2766519|NCT00763256|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||mg/L||Standard Deviation|Mean
2766520|NCT00763256|Primary|HbA1c Levels in Blood|Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||Percentage||Standard Deviation|Mean
2766535|NCT00763048|Primary|Metabolite Associated With Inflammation (Lysine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766521|NCT00763243|Primary|Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)|"The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory."|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
2766522|NCT00763243|Primary|Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)|This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
2766523|NCT00763243|Primary|Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)|This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
2766524|NCT00763139|Secondary|ESR|sed rate|baseline and after 8 weeks on either placebo or pioglitazone||||mm/hr||Standard Deviation|Mean
2766525|NCT00763139|Secondary|C-reactive Protein (CRP)||Measured after 8 weeks of treatment||||mg/dl||Standard Deviation|Mean
2766526|NCT00763139|Primary|Homeostasis Model Assessment (HOMA) for Insulin Sensitivity|Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose * Insulin/22/5|Measured after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
2766527|NCT00763139|Primary|Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)|A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH|Measured after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
2766528|NCT00763061|Secondary|Mean IOP Change at 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 4 PM||||mmHg||Standard Deviation|Mean
2766529|NCT00763061|Primary|Week 12 - Mean IOP At 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At the 4 PM time point for the patient's worse eye.||||mmHg||Standard Deviation|Mean
2766530|NCT00763061|Secondary|Mean IOP Change From Baseline at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 9 AM||||mmHg||Standard Deviation|Mean
2766531|NCT00763061|Primary|Mean Intraocular Pressure (IOP) at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At Week 12 - At the 9 AM time point for the patient's worse eye.||||millimeters mercury (mmHg)||Standard Deviation|Mean
2766532|NCT00763048|Primary|Metabolite Associated With Inflammation (Xanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766533|NCT00763048|Primary|Metabolite Associated With Inflammation (Putrescine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766534|NCT00763048|Primary|Metabolite Associated With Inflammation (Phenylalanine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766536|NCT00763048|Primary|Metabolite Associated With Inflammation (Leucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766537|NCT00763048|Primary|Metabolite Associated With Inflammation (Isoleucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766538|NCT00763048|Primary|Metabolite Associated With Inflammation (Inosine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766539|NCT00763048|Primary|Metabolite Associated With Inflammation (Hypoxanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766540|NCT00763048|Primary|Metabolite Associated With Inflammation (Choline)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766541|NCT00763048|Primary|Metabolite Associated With Inflammation (Cadaverine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
2766542|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing)|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Episodes of (SBP>140), low number represent better outcome. Episodes of arrhythmias (including PVCs) and bradycardia (HR<60), low number represent better outcome. Episodes of wheezing and SPO2<94%, low number represent better outcome.|1 day||||number of episodes||Full Range|Mean
2766543|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome.|1 day||||units on a scale||Full Range|Mean
2766544|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Low scores represent better outcome.|1 day||||number of episodes||Full Range|Mean
2766545|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire|To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Level of monitoring - Scale from 1(most easy among all MRI tests) to 4(most difficult), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure - Scale from 1(very difficult) to 4(very easy), higher scores represent better outcome.|1 day||||units on a scale||Full Range|Mean
2766546|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing)|Ease of Administration of regadenoson versus intravenous dobutamine using Compare MD Questionnaire. Episodes of arrhythmias (including PVCs) and bradycardia (HR<60), low score represent better outcome. Number of Episodes of wheezing and SPO2<94%, low numbers represent better outcome.|1 day||||number of episodes||Full Range|Mean
2766547|NCT00763035|Secondary|Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire|The Compare MD tool have the following scales: Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure (1 very Difficult to 5 very easy), higher scores represent better outcomes.|1 day||||units on a scale||Full Range|Mean
2766548|NCT00763035|Primary|Duration of Procedures|To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.|1 day||||Minutes||Full Range|Mean
2766550|NCT00763009|Primary|To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.|To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling|6-12 months|"All patients responded. Function and Expression of the Transporter were therefore not performed.~The study was terminated due to poor enrollment"||||||
2766551|NCT00762996|Secondary|Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable|1 week||||Units on a scale||Standard Error|Least Squares Mean
2766552|NCT00762996|Primary|Distance Visual Acuity|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|1 week||||logMar||Standard Error|Least Squares Mean
2766553|NCT00762970|Primary|Axial Length (Axial Elongation)|Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)|eyes|Standard Deviation|Mean
2766554|NCT00762970|Primary|Spherical Equivalent Refraction|Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)|eyes|Standard Deviation|Mean
2766555|NCT00762931|Secondary|Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).|"An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes).~Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1.~The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%."|60 minutes|Safety population. 1 subject result missing due to no stimulation performed.|||Participants|||Count of Participants
2766556|NCT00762931|Primary|Safety- Number of Participants With Adverse Events|Safety- Number of participants that reported Adverse Events|2 weeks|Safety|||Participants|||Count of Participants
2766557|NCT00762892|Secondary|Change From Baseline in Homocysteine at 6 Months||Baseline and 48 weeks||||umol/L||Standard Deviation|Mean
2766558|NCT00762892|Secondary|Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks||Baseline and 48 weeks||||pg/mL||Standard Deviation|Mean
2766559|NCT00762892|Primary|Change From Baseline in Log HIV Viral Load at 48 Weeks||Baseline and 48 weeks||||copies/mL||Standard Deviation|Mean
2766560|NCT00762892|Secondary|Change From Baseline in Lipids at 48 Weeks||Baseline and 48 weeks||||mg/dL||Standard Deviation|Mean
2766561|NCT00762892|Primary|Change From Baseline in CD4 Count at 48 Weeks||Baseline and 48 weeks||||cells/uL||Standard Deviation|Mean
2766562|NCT00762853|Primary|Triclosan Concentration in Dental Plaque|Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.|12 hours||||ppm levels of triclosan||Standard Deviation|Mean
2766563|NCT00762788|Primary|Incidence of Adverse Events|Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.|||percentage of participants||95% Confidence Interval|Number
2766564|NCT00762788|Primary|Incidence of Corneal Infiltrative Events|Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.|||percentage of participants||95% Confidence Interval|Number
2766565|NCT00762762|Primary|TNF-α (Tumor Necrosis Factor - Alpha)|Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.|12 months||||pg/ml||Standard Deviation|Mean
2766566|NCT00762762|Primary|IL-6 (Interleukin - 6)|Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)|12 months||||pg/ml||Standard Deviation|Mean
2766567|NCT00762762|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin|12 months||||ng/ml||Standard Deviation|Mean
2766568|NCT00762762|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.|12 months||||µg/ml||Standard Deviation|Mean
2766569|NCT00762762|Primary|HbA1c Levels in Blood|Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.|12 months||||percentage of HbA1c levels||Standard Deviation|Mean
2766570|NCT00762723|Primary|Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)|- Fusion Assessment|Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months|Data not analyzed because study was stopped due to slow enrollment.||||||
2766571|NCT00762645|Secondary|Number of Patients With Peripheral Anterior Synechiae (PAS)||Week 12 Visit||||Participants|||Number
2766572|NCT00762645|Primary|Mean Intraocular Pressure (IOP)||4PM at Week 12 Visit||||millimeters mercury (mm Hg)||Standard Deviation|Mean
2766573|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766574|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766575|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766576|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766577|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766578|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766579|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)-Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766580|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766581|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766582|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766583|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766584|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766585|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766586|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766587|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766588|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766589|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766590|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766591|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766592|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766593|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766594|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766595|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766596|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766597|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766598|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766599|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766600|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766601|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766602|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766603|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766604|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766605|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766606|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766607|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766608|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766609|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766610|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766611|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766612|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766613|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766614|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766615|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766616|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766617|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766618|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766619|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766620|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766621|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766622|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766623|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766624|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766625|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766626|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766627|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
2766628|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).|3 months||||Log cfu (Colony Forming Units)||Standard Error|Least Squares Mean
2766629|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|6 months||||Units on a scale||Standard Deviation|Mean
2766630|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|3 months||||Units on a scale||Standard Deviation|Mean
2766631|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.|6 months||||Units on a scale||Standard Deviation|Mean
2766647|NCT00762528|Secondary|Dental Plaque Index (PI)|measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.|29 days||||Units on a scale||Standard Deviation|Mean
2766632|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.|3 months||||Units on a scale||Standard Deviation|Mean
2766633|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months||||units on a scale||Standard Deviation|Mean
2766634|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months||||units on a scale||Standard Deviation|Mean
2766635|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months||||units on a scale||Standard Deviation|Mean
2766636|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months||||units on a scale||Standard Deviation|Mean
2766637|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months||||units on a scale||Standard Deviation|Mean
2766638|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months||||units on a scale||Standard Deviation|Mean
2766639|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months||||units on a scale||Standard Deviation|Mean
2766640|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months||||units on a scale||Standard Deviation|Mean
2766641|NCT00762606|Secondary|Corneal Astigmatism|Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.|3 months after surgery||||Diopters||Standard Deviation|Mean
2766642|NCT00762606|Primary|Posterior Capsule Opacification Evaluation|The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.|12 months after surgery||||participants|||Number
2766643|NCT00762528|Primary|8-iso-prostaglandinF2α (8-iso-PGF2α)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
2766644|NCT00762528|Primary|Nuclear Factor Kappa B Ligand (RANK-L)|Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
2766645|NCT00762528|Primary|Interleukin-6 (IL-6)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
2766646|NCT00762528|Secondary|Bleeding on Probing (BOP)|Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.|29 days||||Units on a scale||Standard Deviation|Mean
2766648|NCT00762528|Primary|Interleukin - 1 Beta (IL-ß)|Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
2766649|NCT00762528|Primary|Prostaglandin E2 (PGE2)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
2766650|NCT00762528|Primary|Gingival Index (GI)|"Gingival Index(GI)recorded on scale of 0-3 detailed below:~0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed"|29 days||||units on a scale||Standard Deviation|Mean
2766651|NCT00762515|Secondary|Control Gingivitis in Adults|Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).|6 weeks||||Units on a scale||Standard Deviation|Mean
2766652|NCT00762515|Primary|Control Established Plaque in Adults|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.|6 weeks||||Units on a scale||Standard Deviation|Mean
2766653|NCT00762502|Primary|Tarsal Roughness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
2766654|NCT00762502|Primary|Bulbar Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
2766655|NCT00762502|Primary|Limbal Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
2766656|NCT00762502|Primary|Corneal Staining|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
2766657|NCT00762476|Secondary|Rhinovirus-associated Colds|The incidence of rhinovirus-associated cold illnesses.|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||RV-associated cold illnesses per 100 sub|||Number
2766658|NCT00762476|Secondary|Rhinovirus Infections.|The incidence of rhinovirus infections|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||rhinovirus infections per 100 subjects|||Number
2766659|NCT00762476|Primary|The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.|Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||cold illnesses per 100 subjects|||Number
2766660|NCT00762463|Secondary|Paracetamol Tablets Taken Per Day by Participant|Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.|Week 6|FAS|||tablets per day||Standard Deviation|Mean
2766661|NCT00762463|Secondary|Percentage of Days With Concomitant Administration of Paracetamol|Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.|Week 6|FAS|||percentage of days||Standard Deviation|Mean
2766662|NCT00762463|Secondary|Percentage of Participants With Concomitant Use of Paracetamol|Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6|Week 6|FAS|||percentage of participants|||Number
2766663|NCT00762463|Secondary|Change From Baseline in CRP at Week 12|CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mg/L||Standard Deviation|Mean
2766664|NCT00762463|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 6|C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.|Baseline, 6 Weeks|FAS|||mg/L||Standard Error|Least Squares Mean
2774149|NCT00711009|Secondary|Mean Change From Baseline in Uric Acid (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2766665|NCT00762463|Secondary|Change From Baseline in ESR at Week 12|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm/h||Standard Deviation|Mean
2766666|NCT00762463|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6|Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.|Baseline, Week 6|FAS|||mm/h||Standard Error|Least Squares Mean
2766667|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Week 12|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||cm||Standard Deviation|Mean
2766668|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Weeks 2, 4, and 6|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||cm||Standard Error|Least Squares Mean
2766669|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Week 12|Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||cm||Standard Deviation|Mean
2766670|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6|Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||cm||Standard Error|Least Squares Mean
2766671|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Week 12|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
2766672|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
2766673|NCT00762463|Secondary|Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20|Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).|Weeks 2, 4, 6, 12|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||percentage of participants|||Number
2766674|NCT00762463|Secondary|Change From Baseline in BASDAI at Week 12|BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
2766675|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6|Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
2766676|NCT00762463|Secondary|Change From Baseline in BASFI at Week 12|BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
2766677|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6|Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
2766678|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||units on a scale||Standard Deviation|Mean
2774150|NCT00711009|Secondary|Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2766679|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6|5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||units on a scale||Standard Error|Least Squares Mean
2766680|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||units on a scale||Standard Deviation|Mean
2766681|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||units on a scale||Standard Error|Least Squares Mean
2766682|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
2766683|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement."|Baseline, Weeks 2, 4|Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
2766684|NCT00762463|Primary|Participant's Assessment of Global Pain Intensity at Baseline|"100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain."|Baseline|PP|||mm||Standard Deviation|Mean
2766685|NCT00762463|Primary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6|"100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement."|Baseline, Week 6|Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.|||mm||Standard Error|Least Squares Mean
2766686|NCT00762450|Primary|ph of Dental Plaque After Sucrose Challenge|Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.|1 week||||ph of dental plaque||Standard Deviation|Mean
2766687|NCT00762424|Primary|Time of Stone Passage|Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.|10 Days||||hours||Inter-Quartile Range|Median
2766688|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2766689|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2766690|NCT00762411|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2766691|NCT00762411|Secondary|Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2774151|NCT00711009|Secondary|Mean Change From Baseline in Creatinine (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2766692|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766693|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2766694|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug|Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2766695|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug|Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2766696|NCT00762411|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2766697|NCT00762411|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug|Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2766698|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2766738|NCT00762359|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|18 Months||||participants|||Number
2766699|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug|Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2766700|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2766701|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.|||liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2766702|NCT00762411|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2766703|NCT00762411|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2766704|NCT00762411|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
2766705|NCT00762411|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
2766706|NCT00762411|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2766707|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766708|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks|Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766709|NCT00762411|Secondary|Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766710|NCT00762411|Secondary|Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||number of hospitalizations||Standard Error|Least Squares Mean
2766711|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766712|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2766713|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2766714|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766715|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2766716|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2766717|NCT00762385|Primary|Comfort Symptoms|A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable|1-week, 2-weeks|Only participants who completed the study per protocol (n=78)|||score||Standard Error|Least Squares Mean
2766718|NCT00762385|Secondary|Overall Corneal Staining|Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|2 weeks|Only the participants who completed the study per protocol (n=78)|||combined score||Standard Error|Least Squares Mean
2766719|NCT00762385|Primary|Lens Comfort|>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.|1-week, 2- weeks|Only participants who completed the study per protocol (n=78)|||combined score||Standard Error|Least Squares Mean
2766737|NCT00762372|Primary|Number of Participants With Body Movement During Anesthetic Maintenance|The investigator or sub-investigator observed the patient for body movement (excluding bucking) during anesthetic maintenance.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|Full Analysis Set (FAS) - subjects assigned to treatment groups, excluding subjects with significant GCP violations (significant violations regarding informed consent and study procedures), subjects who did not receive the allocated study drug, subjects whose ASA status was not Class I, II, III, or subjects for whom no data were available.|||participants|||Number
2766720|NCT00762372|Secondary|End-Tidal Anesthetic Percent Concentrations Successfully Maintained Anesthesia|Successfully maintaining anesthesia is defined as keeping the patient in stable condition (systolic pressure 80 to <150 mmHg and heart rate 50 to <100bpm) without requiring rescue treatment or additional dose of opioid analgesics (<=2 ug/kg/hr).If patient was found to have body movement, recall, or memory during anesthetic maintenance, data for such patient were to be excluded from summary statistic calculation.|Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation]|FAS|||percentage||Standard Deviation|Mean
2766721|NCT00762372|Secondary|Range of Inspired Anesthetic Concentrations Below End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance|Measurement by infrared absorption spectrometry. Ranges reflecting when concentrations were stable. The inspired concentration was adjusted depending on the patient's condition during anesthetic maintenance (gas flow rate: 2 to 6 L/min).|Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, and just before extubation]|FAS|||percentage|||Number
2766722|NCT00762372|Secondary|Range of End-Tidal Anesthetic Percent Concentrations During Anesthetic Maintenance|Measurement by infrared absorption spectrometry. The concentrations of BLM-240 and sevoflurane at the start of inhalation were set at 3% and 1%,respectively (by vaporizer dial setting). Concentrations are monitored to determine which levels keep the patient in stable condition without requiring rescue treatment.|Day 1 [just before the start of inhalation of study drug, during anesthetic maintenance (every 5 minutes after the start of inhalation of study drug), at the end of inhalation of study drug, immediately after awakening, and just before extubation]|FAS|||percentage|||Number
2766723|NCT00762372|Secondary|Number of Participants Requiring Rescue Medication Due to Arrhythmia|Rescue medication can include vasopressors and depressors.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766724|NCT00762372|Secondary|Number of Participants Requiring Rescue Medication Due to Drop in Blood Pressure or Heart Rate|Rescue medication can include vasopressors and depressors.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766725|NCT00762372|Secondary|Number of Participants Requiring Rescue Medication Due to Rise in Blood Pressure or Heart Rate|Rescue medication can include vasopressors and depressors.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766726|NCT00762372|Secondary|Changes in Bispectral Index (BIS) Over Time During Anethetic Maintenance|BIS is used to monitor depth of anesthesia. The BIS monitor provides a single number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 generally indicates an appropriate level for general anesthesia.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||score on a scale||Standard Deviation|Mean
2766727|NCT00762372|Secondary|Time to Clear Consciousness|"Clear consciousness means that patients responded to investigator's command for physical movement such as hold my finger tight."|Day 1 (Post-Surgery, from awakening to before extubation)|FAS|||minutes||Standard Deviation|Mean
2766728|NCT00762372|Secondary|Time to Reaching an Aldrete Score >=8 (Min)|Score includes a ranking of 0-2 (higher shows improvement) in activity, respiration, circulation, consciousness, and O2 saturation (SpO2). After extubation, the investigator observed the patient's condition every 5 minutes until the Aldrete score reached >=8 and recorded the Aldrete scores at 5-minute intervals.|Day 1 (Post-Surgery, after extubation)|FAS|||minutes||Standard Deviation|Mean
2766729|NCT00762372|Secondary|Time to Stating Birth Date|After extubation, the investigator called and asked the patient to state the birth date once every minute and recorded the time the patient could state the birth date. Time from the end of study drug inhalation.|Day 1 (Post-Surgery, after extubation)|FAS|||minutes||Standard Deviation|Mean
2766730|NCT00762372|Secondary|Time to Awakening|Time from the end of study drug inhalation. After the end of inhalation of the study drug, the investigator commanded the patient to open his/her eyes once every minute to check whether he/she awoke and recorded the time of awakening.|Day 1 (Post-Surgery, from the end of study drug inhalation to awakening)|FAS|||minutes||Standard Deviation|Mean
2766731|NCT00762372|Primary|Time to Extubation|Evaluation of Awakening/Recovery from Anesthesia from end of study drug inhalation to extubation. The patient was extubated when the following signs were observed:(1) clear consciousness, (2) ability to breathe spontaneously (minute ventilation >=50 mL/kg/min), and (3) stable circulatory dynamics (systolic pressure: >=100 mmHg).|Day 1 (Post-Surgery, from end of study drug inhalation to extubation)|FAS|||minutes||Standard Deviation|Mean
2766732|NCT00762372|Primary|Overall Assessment of Efficacy|Evaluation on the efficacy (ability) of BLM-240 as an anesthetic drug.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766733|NCT00762372|Primary|Number of Participants Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%|Rescue medication includes vasopressors and depressors. Percentage of observation points at which no rescue treatment was judged to be required based on blood pressure/heart rate|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766734|NCT00762372|Primary|Number of Participants Not Receiving Rescue Treatment Whose Blood Pressure/Heart Rate Maintained Above/Below 70%|"Rescue medication includes vasopressors and depressors. Percentage of observation points at which systolic pressure 80 to <150 mmHg and heart rate 50 to <100 bpm could be maintained "|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766735|NCT00762372|Primary|Number of Participants Requiring Rescue Treatment During Anesthetic Maintenance|Rescue medication includes vasopressors and depressors.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766736|NCT00762372|Primary|Number of Participants With Recall/Memory Issues During Anesthetic Maintenance|The investigator or sub-investigator observed the patient for the presence or absence of awakening during anesthetic maintenance and interviewed the patient on the day after surgery to confirm whether the patient has any memory during anesthetic maintenance.|Day 1 (During surgery, duration ranging <2 hours, 2-4 hours, and ≥4 hours)|FAS|||participants|||Number
2766739|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766740|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766741|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766742|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766743|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766744|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766745|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766746|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766747|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766748|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766749|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766750|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766751|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766752|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766753|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766754|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766755|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766756|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766757|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766758|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766759|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766760|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766761|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766762|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766763|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766764|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766765|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766766|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766767|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766768|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766769|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766770|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766771|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766772|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766773|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766774|NCT00762359|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Values are from the Full Analysis Set.|||participants|||Number
2766775|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766776|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766777|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766778|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766779|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766780|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766781|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766782|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766783|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Median
2766784|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
2766785|NCT00762359|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Participants not taking investigational drug were not included.|||participants|||Number
2766786|NCT00762320|Secondary|Parent Satisfaction|Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 4 week, 12 weeks and 24 weeks||||Score on a survey||Standard Deviation|Mean
2766787|NCT00762320|Primary|Lopinavir and Ritonavir AUC on Low Dose Tablet|Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.|4 weeks|All participants were analyzed|||hr*ng/ml||Standard Deviation|Median
2766788|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks|Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs|4 weeks|All participants were analyzed|||ng/ml||Standard Deviation|Median
2766789|NCT00762320|Primary|Viral Load (VL)|Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study|Baseline, Week 4, Week 12 and Week 24|All subjects in study were analyzed|||participants|||Number
2766790|NCT00762320|Secondary|Symptoms Across All Patients|Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.|Baseline, 1 month, 3 months, 6 months|All participants analyzed|||numer of symptoms||Standard Deviation|Mean
2766791|NCT00762320|Secondary|Patient Satisfaction|Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 1 month|Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.|||units on a scale||Standard Deviation|Mean
2766792|NCT00762320|Primary|Lopinavir AUC Ratio of Baseline:Week 4|Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.|Baseline, week 4||||ratio||Standard Deviation|Mean
2766793|NCT00762320|Primary|Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra|Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.|Baseline|All participants were analyzed|||hr*ng/ml||Standard Deviation|Median
2766794|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid|Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.|Baseline|All participants were analyzed|||ng/ml||Standard Deviation|Median
2766795|NCT00762320|Primary|Absolute CD4 and CD4 %|Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.|Baseline, 4 weeks, 12 weeks, 26 weeks|All participants were analyzed.|||participants|||Number
2766796|NCT00762268|Secondary|Young Mania Rating Scale|Rating scale for manic symptoms (range 0-60). A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|6-weeks||||units on a scale||Standard Deviation|Mean
2766797|NCT00762268|Secondary|Hamilton Rating Scale for Depression|Rating scale of depression symptoms (range 0-50). A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|6-weeks||||units on a scale||Standard Deviation|Mean
2766798|NCT00762268|Primary|Montgomery-Asberg Depression Scale (MADRS)|Assessment of current depression symptoms using Montgomery-Asberg Depression Scale (MADRS). All 10 questions on the scale have a 0 (absent)-6(most severe) range for describing symptoms, with the total ranging from 0-60. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|At each weekly visit for 4 weeks||||units on a scale||Full Range|Mean
2766799|NCT00762229|Secondary|Total Cholesterol|Total cholesterol fasting|4 weeks||||mg/dL||Standard Deviation|Mean
2766800|NCT00762229|Primary|LDL Cholesterol|LDL cholesterol|4 weeks||||mg/dL||Standard Deviation|Mean
2766801|NCT00762216|Secondary|Residual Refractive Cylinder|The refractive astigmatism 6 months post-surgery, measured in diopters.|6 Months post-surgery|69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.|||diopters||Standard Error|Mean
2766802|NCT00762216|Primary|Rotational Stability|Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.|6 Months post-surgery|67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.|||degrees||Standard Error|Mean
2766803|NCT00762177|Primary|Antimicrobial Species on the Cheek(Veillonella)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766804|NCT00762177|Primary|Antimicrobial Species in Tongue(Veillonella)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766805|NCT00762177|Primary|Antimicrobial Species in Saliva(Veillonella)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766806|NCT00762177|Primary|Antimicrobial Species in Plaque(Veillonella)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766807|NCT00762177|Primary|Antimicrobial Species on the Cheek(Sulfur Bacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766808|NCT00762177|Primary|Antimicrobial Species in Tongue(Sulfur Bacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766809|NCT00762177|Primary|Antimicrobial Species in Saliva(Sulfur Bacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766810|NCT00762177|Primary|Antimicrobial Species in Plaque(Sulfur Bacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766811|NCT00762177|Primary|Antimicrobial Species on the Cheek(Oral Streptococci)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766812|NCT00762177|Primary|Antimicrobial Species in Tongue(Oral Streptococci)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766813|NCT00762177|Primary|Antimicrobial Species in Saliva(Oral Streptococci)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766814|NCT00762177|Primary|Antimicrobial Species in Plaque(Oral Streptococci)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766815|NCT00762177|Primary|Antimicrobial Species on the Cheek(Fusobacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766816|NCT00762177|Primary|Antimicrobial Species in Tongue(Fusobacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766817|NCT00762177|Primary|Antimicrobial Species in Saliva(Fusobacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766818|NCT00762177|Primary|Antimicrobial Species in Plaque(Fusobacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2767813|NCT00755079|Primary|Inspiratory Respiratory Muscle Strength|Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.||||cmH2O||Standard Deviation|Mean
2766819|NCT00762177|Primary|Antimicrobial Species on the Cheek(Total Anaerobic)|After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766820|NCT00762177|Primary|Antimicrobial Species in Tongue(Total Anaerobic)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766821|NCT00762177|Primary|Antimicrobial Species in Saliva(Total Anaerobic)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766822|NCT00762177|Primary|Antimicrobial Species in Plaque(Total Anaerobic)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766823|NCT00762177|Primary|Antimicrobial Species on the Cheek(Actinomyces)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766824|NCT00762177|Primary|Antimicrobial Species on the Tongue(Actinomycetes)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766825|NCT00762177|Primary|Antimicrobial Species in Saliva(Actinomyces)|Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766826|NCT00762177|Primary|Antimicrobial Species in Plaque(Actinomyces)|After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
2766827|NCT00762164|Secondary|Total Cholesterol||6 weeks||||% change in total cholesterol||Standard Deviation|Mean
2766828|NCT00762164|Primary|LDL Cholesterol||6 weeks||||% change in LDL cholesterol||Standard Deviation|Mean
2766829|NCT00762086|Primary|Absolute Claudication Distance (ACD)|Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters|3 months|ITT cohort|||Meters||Standard Error|Least Squares Mean
2766830|NCT00762073|Secondary|Mean Change in Blood Pressure (BP) at End of Treatment|BP was assessed for each treatment group at baseline and at each post-baseline visit including the final treatment evaluation.|Baseline, 12 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.|||mmHg||Standard Deviation|Mean
2766831|NCT00762073|Secondary|Percent of Participants With Potential Corticosteroid-Related Treatment-Emergent Adverse Events (TEAEs)|Corticosteroid-Related TEAEs included candidiasis, oesophageal candidiasis, crying, psychomotor hyperactivity, aggression, anger, anxiety, conduct disorder, emotional disorder, insomnia, or mood altered mood. Corticosteroid-Related TEAEs were assessed systematically during the treatment and taper periods.|15 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.|||percentage of participants|||Number
2766832|NCT00762073|Secondary|Area Under The Plasma Concentration-Time Curve (AUC) of Budesonide From Time Zero to Time of The Last Measurable Concentration (AUC0-last)|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||hr*pg/mL||Standard Deviation|Mean
2766839|NCT00762073|Secondary|Change From Baseline in Endoscopy Score|Esophageal endoscopy was used to assess the level of inflammation and eosinophilia. Four categories of endoscopic findings were evaluated and scored for this study: (1) pallor and diminished vascular markings; (2) furrowing with thickened mucosa; (3) presence of white mucosal plaques; and (4) concentric rings or strictures. For each category, 0 points were allocated if no esophageal sites were involved, 1 point if 1 or 2 esophageal sites were involved, and 2 points for pan-esophageal involvement (see Aceves et al., 2007). The maximum possible endoscopy score was 8 points. A negative change from baseline indicates that esophageal inflammation decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||scores on a scale||Standard Deviation|Mean
2766833|NCT00762073|Secondary|Time to Maximum (Tmax) And Half Maximum (T1/2) Plasma Concentration of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together. T1/2 is the time to terminal elimination half-life.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||hours||Standard Deviation|Mean
2766834|NCT00762073|Secondary|Maximum Plasma Concentration (Cmax) of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The Pharmacokinetic (PK) Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||pg/mL||Standard Deviation|Mean
2766835|NCT00762073|Secondary|Change From Baseline in Physician's Global Assessment Score of Disease Severity|"Physician investigators were asked to complete a visual analog scale (VAS) to provide a global assessment of eosinophilic esophagitis (EoE) activity in each participant. The VAS was a 100-mm horizontal line on which the right extreme (100) was labeled worst possible disease activity and the left (0) was labeled no disease activity. Investigators were instructed to consider the line for the VAS as a continuum with their own opinion of extremes on either end. Investigators drew a vertical line at a point that best approximated the participant's current level of EoE disease activity. The investigator was to take into consideration how esophageal disease was impacting the participant's daily activities. The following instruction was given to the investigators: Using the visual analog scale below, please mark a vertical line on the scale to indicate your assessment of EoE activity in this participant at this time. A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||scores on a scale||Standard Deviation|Mean
2766836|NCT00762073|Secondary|Percent Change From Baseline in Eosinophilic Esophagitis (EoE) Clinical Symptom Score (CSS)|"The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1= Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2= Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3= Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors.~A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percent change||Standard Deviation|Mean
2766837|NCT00762073|Secondary|Percent of Participants With Clinical Remission|"Clinical remission was defined as an eosinophilic esophagitis (EoE) clinical symptom score (CSS) of zero. EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
2766838|NCT00762073|Secondary|Percent of Participants With Clinical Response|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS). The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
2766840|NCT00762073|Secondary|Percent Change From Baseline in Peak Eosinophil Count|The maximum peak number of eosinophils at baseline and at the final treatment evaluation was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value. A negative change from baseline indicates that eosinophil count has decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percent change||Standard Deviation|Mean
2767851|NCT00754624|Secondary|Annual Rate of Change in DLCo From Baseline to End of Study||Baseline to 48 months|Safety|||mL/min/mmHg per year||Standard Error|Mean
2766841|NCT00762073|Secondary|Percent of Participants With Histologic Remission|Histologic remission was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤1 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
2766842|NCT00762073|Secondary|Percent of Participants With Histologic Response|Histologic response was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤6 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
2766843|NCT00762073|Primary|Percent of Participants Who Responded to Therapy|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The Full Analysis Set (FAS), defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
2766844|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression|Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score >0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with FR-α Cytoplasm or Membrane H scores. Participants censored: FR-α Positive Cytoplasm n=21, 15 and Negative n=4, 3; FR-α Membrane Positive n=16, 8 and Negative n=9, 10 for Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
2766845|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression|Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score >0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TS Cytoplasm and Nucleus H scores. Participants censored: TS Cytoplasm Positive n=23, 20 and Negative n=4, 1; TS Nucleus Positive n=17, 9 and Negative n=10, 12 for the Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
2766846|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment|Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score >0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TTF-1 H scores regardless of study treatment. Participants censored: n=38, 11 in the TTF-1 Nuclear Positive and Negative arms, respectively.|||months||95% Confidence Interval|Median
2766847|NCT00762034|Secondary|Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations|Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).|Baseline|All randomized participants with EGFR data regardless of study treatment.|||participants|||Number
2766848|NCT00762034|Secondary|Pharmacokinetics (PK): Bevacizumab Clearance (CL)||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.|||liters per day (L/day)||Geometric Coefficient of Variation|Geometric Mean
2766849|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.|||microgram*day per milliliter (μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
2766850|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.|||days||Geometric Coefficient of Variation|Geometric Mean
2766851|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2766852|NCT00762034|Secondary|Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2766853|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.|||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2766854|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
2766855|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2766856|NCT00762034|Secondary|Pharmacokinetics (PK): Pemetrexed Clearance (CL)||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable CL data.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2766857|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable AUC(0-∞) data.|||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2766858|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable t1/2 data.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
2766859|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2766860|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)|"FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items; each uses a 5 point rating scale (0=not at all and 4=equals very much). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT/GOG-Ntx data, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
2766861|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)|"FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-L, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
2766862|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)|"The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
2766865|NCT00762034|Secondary|Duration of Hospitalizations Per Participant|Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation.|||days||Standard Deviation|Mean
2766866|NCT00762034|Secondary|Safety and Toxicity Profile of Study Treatments|Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug during the specified treatment phase.|||participants|||Number
2766867|NCT00762034|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
2766868|NCT00762034|Secondary|Progression Free Survival Time|Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
2766869|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)|Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle|||percentage of participants||95% Confidence Interval|Number
2766870|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)|Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle|||percentage of participants||95% Confidence Interval|Number
2766871|NCT00762034|Primary|Overall Survival|Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
2766872|NCT00762021|Primary|9% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.|||LogMAR||Standard Deviation|Mean
2766873|NCT00762021|Primary|100% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.|||LogMAR||Standard Deviation|Mean
2766874|NCT00762021|Primary|Posterior Capsule Opacification (PCO)|Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.|2 years after surgery|Data for all patients completing the 24 month visit were analyzed.|||Percentage of PCO||Standard Deviation|Mean
2766875|NCT00761969|Secondary|Incidence of Revascularization Procedures|Incidence of coronary, carotid and peripheral arterial revascularization procedures|5 years||||participants|||Number
2766876|NCT00761969|Primary|Incidence of Major Cardiovascular Events|Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.|5 years:||||participants|||Number
2767018|NCT00760877|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Months||95% Confidence Interval|Median
2766877|NCT00761956|Secondary|Return to Function (RtF) Via Knee Scoiety Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|24 Months|There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully.|||units on a scale||Standard Deviation|Mean
2766878|NCT00761956|Primary|Postoperative Range of Motion (ROM)|The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.|24 Months|There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48.|||degrees||Standard Deviation|Mean
2766879|NCT00761930|Primary|Bleeding Index (EIBI)|Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.|6 weeks||||Units on a scale||Standard Deviation|Mean
2766880|NCT00761930|Primary|Gingivitis Score|"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored."|6 weeks||||Units on a scale||Standard Deviation|Mean
2766881|NCT00761930|Primary|Dental Plaque|Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.|6 weeks||||Units on a scale||Standard Deviation|Mean
2766882|NCT00761891|Secondary|Serum Thromboxane|SerumTxB2: They are formed from the prostaglandin endoperoxides and cause platelet aggregation, contraction of arteries, and other biological effects.|Baseline and at 2 weeks||||ng/ml||Standard Error|Mean
2766883|NCT00761891|Primary|A Reference Range in Normal Volunteers Taking a Routine Clinical Dose of Aspirin (81mg Daily) for 2 Weeks|"Determine the level of Thromboxane B2 at which patients with a result above are not fully inhibited, and patients with a TxB2 level below are fully inhibited.~The reference range is the level of serum thromboxane at which participants below have fully inhibited COX-1 and participants above do not have fully inhibited COX-1 activity"|2 weeks||||ng/ml||75% Confidence Interval|Number
2766884|NCT00761865|Secondary|Patient Satisfaction (Measured on a Visual Analog Scale)|Satisfaction on 0-10 scale with 10 being the best.|2 weeks post-sprain||||units on a scale||Full Range|Mean
2766885|NCT00761865|Primary|Modified Karlsson Score|Ankle function score - range 0 to 100. Higher score is better ankle function.|2 weeks post-sprain||||units on a scale||Full Range|Mean
2766886|NCT00761813|Secondary|Complications, Including Avascular Necrosis, Nonunion, and Infection||Measured 2 years after original surgery||||participants|||Number
2766887|NCT00761813|Secondary|Quality of Life|The SF-12 PCS is the short form - 12 Health Survey Physical component summary - 0 is bad and 100 is good The WOMAC is Western Ontario and McMaster Universities Osteoarthritis Index 0 is good and 100 is bad The EQ-5D is EuroQol5D 1 is good and 5 is bad|Measured 2 years after original surgery|secondary outcomes not given or completed to all subjects|||units on a scale||Standard Deviation|Mean
2766888|NCT00761813|Primary|Revision Surgery|Additional Surgery on the affected hip|Measured 2 years after original surgery||||Participants|||Count of Participants
2766889|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
2766890|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
2766891|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
2766892|NCT00761774|Primary|Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
2766893|NCT00761774|Primary|Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
2766894|NCT00761774|Primary|Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
2766895|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms|Symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HARS). Minimum score = 0, Maximum score = 60. Higher scores on HARS indicate worse functioning|Baseline and 8 week treatment|Stable Bipolar Patients|||units on a scale||Standard Deviation|Mean
2766896|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.|Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.|Baseline and 8 weeks treatment|Stable Bipolar Patients|||units on a scale||Standard Deviation|Mean
2766897|NCT00761761|Secondary|Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms|Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Minimum score = 0, Maximum score = 60. Higher scores on MADRS indicate worse functioning.|Baseline and 8 week treatment|Stable Bipolar patients|||units on a scale||Standard Deviation|Mean
2766898|NCT00761761|Primary|Change From Baseline in Digit-Span Score at 8 Weeks|"Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented.~The raw scores for digit span ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome."|8 week treatment||||units on a scale||Standard Error|Least Squares Mean
2766899|NCT00761748|Primary|Preference of the Two Urostomy Products|"Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.~The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred."|6 weeks|The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). *One drop out was evaluable, as the subject tried both products and stated a preference.|||participants|||Number
2766900|NCT00761735|Primary|Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender|The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.|Last assessment of the Part 2 LTFU (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.|||years||Standard Deviation|Mean
2766901|NCT00761735|Primary|Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
2766902|NCT00761735|Primary|Mean Weight Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
2766903|NCT00761735|Primary|Mean Height Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
2766904|NCT00761735|Primary|Number of Participants Who Relapsed At End of LTFU Year 5|Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.|Part 2 LTFU Year 5|Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.|||participants|||Number
2766905|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2|Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
2766906|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1|Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.|From the day of dose 1 (Day 1) to Day 7 of dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
2766907|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
2766908|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 1 (Day 1) to Day 7 after dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
2766909|NCT00761631|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4|Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3 and 4|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.|||titer||95% Confidence Interval|Geometric Mean
2766910|NCT00761631|Primary|Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)|Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.|28 to 42 days after dose 1|||||||
2766911|NCT00761631|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3|Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.|||mcg/mL||95% Confidence Interval|Geometric Mean
2766912|NCT00761631|Primary|Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2|Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.|28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2|Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2767852|NCT00754624|Secondary|Annual Rate of Change in FVC From Baseline to End of Study||Baseline to 48 months|Safety|||Liters per year||Standard Error|Mean
2766913|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2766914|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766915|NCT00761605|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766916|NCT00761605|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Millimeter (mm)||Standard Deviation|Mean
2766917|NCT00761605|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Millimeter (mm)||Standard Deviation|Mean
2766918|NCT00761605|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2766919|NCT00761605|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766937|NCT00761527|Secondary|Investigator Assessment of Clinical Efficacy|Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.|Day 15|ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.|||Participants|||Number
2766920|NCT00761605|Primary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2766921|NCT00761592|Secondary|Duration of Action|Median Duration for decision to reinject|Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)|Intention to Treat|||Weeks||Standard Deviation|Median
2766922|NCT00761592|Secondary|Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score|"Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect~+1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement."|Baseline to Week 4 and 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
2766923|NCT00761592|Secondary|Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)|Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.|Baseline to Week 4 and Week 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
2766924|NCT00761592|Secondary|Change From Baseline to Week 8 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
2766925|NCT00761592|Primary|Change From Baseline to Week 4 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 4|Intention to Treat|||Points on Scale||Standard Deviation|Mean
2766926|NCT00761579|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2766927|NCT00761579|Secondary|Change From Baseline in Sleep Quality at Week 48|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||millimeter (mm)||Standard Deviation|Mean
2766928|NCT00761579|Secondary|Change From Baseline in Daytime Drowsiness at Week 48|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||millimeter (mm)||Standard Deviation|Mean
2766950|NCT00761306|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
2767127|NCT00760266|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8||Baseline and Week 8|Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg)|||mm Hg||Standard Error|Least Squares Mean
2766929|NCT00761579|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2766930|NCT00761579|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2766931|NCT00761579|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766932|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766933|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766934|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766935|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2766936|NCT00761527|Primary|Participant Global Tolerability Assessment|"The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows:~Excellent~Very Good~Good~Fair~poor~Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented."|Day 15|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.|||Participants|||Number
2766938|NCT00761527|Primary|Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment|Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.|||Participants|||Number
2766939|NCT00761527|Primary|Number of Adverse Events Reported By Category After 14 Days of Treatment|Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.|||Adverse Events|||Number
2766940|NCT00761514|Primary|Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.|Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.|Week 24 of treatment|Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.|||Percent change in average total score|||Number
2766941|NCT00761514|Secondary|Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score|On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.|Week 24 of treatment|Available subject data were used in calculations. Missing data were not imputed.|||Percent change in average score|||Number
2766942|NCT00761462|Primary|Incidence of Nervous System Events (Cumulative)|Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug).|||participants|||Number
2766943|NCT00761462|Primary|Incidence of Arthropathy (Cumulative)|Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug)|||participants|||Number
2766944|NCT00761345|Secondary|To Measure Progression Free Survival and Overall Survival||Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival|||||||
2766945|NCT00761345|Primary|To Determine the Dose Limiting Toxicities||weekly physician and nurse assessment and in between as needed until 30 days after treatment termination|27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.|||participants|||Number
2766946|NCT00761319|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.|Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.|||Percentage of patients|||Number
2766947|NCT00761319|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.|Day 0, Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.|||Units on a scale||Standard Error|Mean
2766948|NCT00761306|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC|||percentage of patients|||Number
2766949|NCT00761306|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC|||percentage of patients|||Number
2767128|NCT00760266|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set, restricted to baseline msDBP >= 90 mmHg|||mm Hg||Standard Error|Least Squares Mean
2766951|NCT00761306|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)|||units on a scale||Standard Deviation|Mean
2766952|NCT00761306|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
2766953|NCT00761306|Primary|Number of Patients With Adverse Events (AEs)||Up to 52 weeks and a 4-week safety follow-up period|APTS|||participants|||Number
2766954|NCT00761280|Secondary|Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)|Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||days||95% Confidence Interval|Median
2766955|NCT00761280|Secondary|Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|"Tumor response was classified based on the (neuro-)radiologist's evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21 and 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
2766956|NCT00761280|Secondary|Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist's evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21, and 24 months|The Intent-to-treat population includes all participants randomized.|||participants|||Number
2766957|NCT00761280|Secondary|Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)|"Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate.~Censoring rules were:~at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death.~at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression~at the date of death or last tumor assessment -- death or PD after one missed tumor assessment~at the date of last tumor assessment -- death or PD after more than one missed tumor assessment~at the date of last tumor assessment -- participants on ongoing treatment at data cut-off"|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||days||95% Confidence Interval|Median
2766958|NCT00761280|Primary|Survival at 24 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to / insufficient follow-up includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point."|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||participants|||Number
2766959|NCT00761280|Secondary|Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
2766960|NCT00761280|Secondary|Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
2766991|NCT00761202|Secondary|Ocular Comfort and Ocular Symptoms on Visual Analogue Scale|Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)|week 1, month 1|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
2767129|NCT00760266|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
2766961|NCT00761280|Secondary|Response Category by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist's evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response."|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||participants|||Number
2766962|NCT00761280|Secondary|Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)|Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation.|Up to 24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||days||95% Confidence Interval|Median
2766963|NCT00761280|Secondary|Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to follow-up for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point."|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||participants|||Number
2766964|NCT00761280|Secondary|Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||percentage of participants||95% Confidence Interval|Number
2766965|NCT00761280|Primary|Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||percentage of participants||95% Confidence Interval|Number
2766966|NCT00761267|Secondary|All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits||Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2766967|NCT00761267|Secondary|Percentage of Participants With New Infection|New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral).|During 2 week follow-up (up to 63 days) and 6 week follow-up (up to 91 days) after EOT|The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.|||percentage of participants|||Number
2766968|NCT00761267|Secondary|Percentage of Participants With Relapsed Response|Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral).|During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.|||percentage of participants|||Number
2766992|NCT00761202|Secondary|Conjunctival Hyperaemia|Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
2767166|NCT00759902|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||ng/mL||Standard Deviation|Mean
2766969|NCT00761267|Secondary|Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)|The probabilities of a global response of success or failure were compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. For the analysis of this outcome measure, global response was categorized as: success or failure. Success defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection [CI]). Failure defined as CR of failure (no significant improvement in signs symptoms/ death due to CI) and/or microbiological failure (persistence/new infection at follow-up/relapse of infection at follow-up).|EOIVT (maximum of 35 days) and EOT (maximum of 49 days)|mITT population: participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||percentage of participants|||Number
2766970|NCT00761267|Secondary|Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)|The probability of having at least one GI adverse event whilst on Anidulafungin treatment was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures.|Baseline to EOIVT (maximum of 35 days)|Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available.|||Participants|||Count of Participants
2766971|NCT00761267|Secondary|Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)|The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures.|Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days)|Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available.|||Participants|||Count of Participants
2766972|NCT00761267|Secondary|Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin|Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.|Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion|PK population included all those participants who had 1 or more PK samples available.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
2766973|NCT00761267|Secondary|Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin|AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.|Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion|PK population included all those participants who had 1 or more PK samples available.|||microgram*hour per milliliter(mcg*hr/ml)||Standard Deviation|Mean
2766974|NCT00761267|Secondary|Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup|Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.|Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose|The PK subgroup population for PS80 included the last eight participants aged between 1 month to <2 years.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2766975|NCT00761267|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup|Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.|Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose|The PK subgroup population for PS80 included the last eight participants aged between 1 month to <2 years.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2766976|NCT00761267|Secondary|Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup|Cmax was obtained directly from the observed concentration data on Day 2.|Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion|PK subgroup population included the first 6 participants aged between 1 month to <2 years.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2766977|NCT00761267|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup|Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule.|Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion|PK subgroup population included the first 6 participants aged between 1 month to <2 years.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2766993|NCT00761202|Secondary|Corneal Staining by Fluorescein|Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
2766994|NCT00761202|Primary|Conjunctival Staining by Lissamine Green|Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
2767184|NCT00759759|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
2766978|NCT00761267|Secondary|Number of Participants With Global Response|Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection[CI]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral).|End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)|The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.|||Participants|||Count of Participants
2766979|NCT00761267|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.EOT visit defined as last day of study treatment (IV or oral).|Baseline up to 6 weeks after EOT (up to 91 days)|The safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2766980|NCT00761267|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral).|Baseline up to 6 weeks after EOT (up to 91 days)|The safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2766981|NCT00761215|Secondary|Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set||21-28 days after last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.|||Percentage of participants||95% Confidence Interval|Number
2766982|NCT00761215|Secondary|Population PK||Multiple|||||||
2766983|NCT00761215|Secondary|To Evaluate the Safety Profile of Tedizolid Phosphate||Multiple|||||||
2766984|NCT00761215|Secondary|Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set|Persistent clinical cure was defined as continuing favorable response.|21 to 28 days after the last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.|||Percentage of Participants|||Number
2766985|NCT00761215|Secondary|Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set|Satisfactory microbiological outcomes are eradication and presumed eradication|7-14 days after last dose of study drug|The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen.|||Percentage of participants||95% Confidence Interval|Number
2766986|NCT00761215|Secondary|Response Rate at End of Therapy|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|last day of study treatment|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection|||Percentage of participants||95% Confidence Interval|Number
2766987|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7-14 days after last dose of study drug|The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection.|||Percentage of participants||95% Confidence Interval|Number
2766988|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7 to 14 days after the last dose of study drug|The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors.|||Percentage of participants||95% Confidence Interval|Number
2766989|NCT00761202|Secondary|Lipid Layer Pattern Assessment|Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.|Week 1, month 1|Intent to Treat Population|||Lipid Layer Mixing Pattern||Full Range|Median
2766990|NCT00761202|Secondary|Daily Eyedrop Usage|Average daily eyedrop use|Month 1|Intent to Treat Population|||drops/day||Standard Deviation|Mean
2766995|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Participants|||Number
2766996|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Participants|||Number
2766997|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Units on a scale||Standard Deviation|Mean
2766998|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Units on a scale||Standard Deviation|Mean
2766999|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2767000|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2767001|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Percentage of Participants|||Number
2767002|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Percentage of participants|||Number
2767003|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Units on a scale||Standard Deviation|Mean
2767017|NCT00761007|Primary|Response of Overall IBS Symptom Relief - 50% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 2/4 weeks (50% rule)"|Four weeks|Intention-to-Treat (N=544)|||Participants|||Number
2767004|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Units on a scale||Standard Deviation|Mean
2767005|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Percentage of participants|||Number
2767006|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Percentage of participants|||Number
2767007|NCT00761176|Primary|The Incidence of Wounds Reaching Complete Closure||approximate one year|Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.||||||
2767008|NCT00761150|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.|||scores on a scale||Standard Error|Least Squares Mean
2767009|NCT00761150|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).|||scores on a scale||Standard Error|Least Squares Mean
2767010|NCT00761137|Secondary|Percentage Change in Saliva Volume|Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.|Before and 75 minutes after treatment administration|Percentage saliva volume change was determined in the last seven (7) patients enrolled.|||percentage change of saliva volume||95% Confidence Interval|Median
2767011|NCT00761137|Primary|Sialorrhea Visual Analogue Scale (VAS)|Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.|Before and 120 min after treatment administration||||cm on VAS||Standard Deviation|Mean
2767012|NCT00761085|Secondary|Pain Relief|Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced|72 hr||||units on a scale||Standard Deviation|Mean
2767013|NCT00761085|Primary|To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.|R-Methadone AUC|96 hr||||(hr*ng/ml)||Standard Deviation|Mean
2767014|NCT00761007|Secondary|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)|||Participants|||Number
2767015|NCT00761007|Post-Hoc|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat subgroup of patients with IBS-D and baseline pain score>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189)|||Participants|||Number
2767016|NCT00761007|Secondary|Response of Overall IBS Symptom Relief - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-Treat (N=544)|||Participants|||Number
2767853|NCT00754624|Primary|Annual Rate of Change in FEV1 From Baseline to End of Study||Baseline to 48 months|Safety Population defined as all subjects who received at least one dose of study drug|||Liters per year||Standard Error|Mean
2767019|NCT00760877|Secondary|Event-free Survival|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Months||95% Confidence Interval|Median
2767020|NCT00760877|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.|48 months|24 months, Non-responders|||months||95% Confidence Interval|Median
2767021|NCT00760877|Secondary|Number of Cross-over Participants With CMR|The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 months, 48 months|Participants from the Imatinib treatment group who crossed over to the Nilotinib treatment group were analyzed.|||Participants|||Number
2767022|NCT00760877|Secondary|Rate of Confirmed Best Cumulative CMR|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 month, 48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Participants|||Number
2767023|NCT00760877|Primary|Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|12 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Participants|||Number
2767024|NCT00760838|Secondary|Change in Total Score on the Asthma-related Quality of Life (AQLQ)|"A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease~32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)~7-point Likert scale (7 = not impaired at all - 1 = severely impaired).~Scores range 1-7, with higher scores indicating better quality of life."|from baseline to week 26|intention to treat analysis|||units on a scale||Standard Deviation|Mean
2767025|NCT00760838|Secondary|Change in Total Score on Asthma Control Questionnaire (ACQ)|"A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.~ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff~Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)~Scores range between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to week 26|intention to treat analysis|||units on a scale||Standard Deviation|Mean
2767026|NCT00760838|Secondary|Change in Forced Expiratory Volume in 1 Second||from baseline to week 26|intention to treat analysis|||percentage of baseline FEV1||Standard Deviation|Mean
2767027|NCT00760838|Secondary|Peakflow Measurements|change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second|from baseline to week 26|intention to treat analysis|||L/min||Standard Deviation|Mean
2767028|NCT00760838|Secondary|Proportion of Participants Using Rescue Medication From Baseline to Week 26|"proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.~This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26."|from baseline to week 26|intention to treat analysis|||proportion of participants||Standard Deviation|Mean
2767029|NCT00760838|Primary|Proportion of Participants With Severe Asthma Exacerbations|Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.|from baseline to week 26|intention to treat analysis|||proportion of participants||95% Confidence Interval|Mean
2767061|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
2767030|NCT00760747|Secondary|Number of Participants With Suicidal Behaviors and Ideations|"Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||participants|||Number
2767031|NCT00760747|Secondary|Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||kilogram||Standard Deviation|Mean
2767032|NCT00760747|Primary|Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 2 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
2767033|NCT00760747|Secondary|Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||beats per minute||Standard Deviation|Mean
2767034|NCT00760747|Secondary|Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||mmHg||Standard Deviation|Mean
2767035|NCT00760747|Secondary|Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint|The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2767036|NCT00760747|Secondary|Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint|CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score- Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||standard deviation units||Standard Error|Least Squares Mean
2767037|NCT00760747|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint|The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
2767038|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
2767039|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
2767062|NCT00760617|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||titers||95% Confidence Interval|Geometric Mean
2767040|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
2767041|NCT00760747|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
2767042|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction|An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
2767043|NCT00760669|Primary|Number of Participants With Adverse Drug Reactions|"Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as not related."|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
2767044|NCT00760669|Primary|Number of Participants With Unexpected Adverse Events|Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
2767045|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
2767046|NCT00760669|Primary|Overall Efficacy Assessment|The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.|Baseline up to Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.|||Participants|||Number
2767047|NCT00760669|Primary|Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30|The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline and Week 30|Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.||||||
2767048|NCT00760669|Primary|Change From Baseline in Number of Tender Joints at Week 30|Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Tender joints||Standard Deviation|Mean
2767049|NCT00760669|Primary|Change From Baseline in Number of Swollen Joints at Week 30|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Swollen joints||Standard Deviation|Mean
2767063|NCT00760617|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
2767050|NCT00760669|Primary|Change From Baseline in C-Reactive Protein (CRP) at Week 30|The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Milligram per deciliter||Standard Deviation|Mean
2767051|NCT00760669|Primary|Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30|The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure.|||Millimeter per hour||Standard Deviation|Mean
2767052|NCT00760669|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30|The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure.|||Millimeter||Standard Deviation|Mean
2767053|NCT00760617|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
2767054|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
2767055|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
2767056|NCT00760617|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||fold increase||95% Confidence Interval|Geometric Mean
2767057|NCT00760617|Secondary|HI Antibody Seroconversion Factor (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
2767058|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
2767059|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
2767060|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
2767064|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 180 to Day 209|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767065|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767066|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767067|NCT00760617|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767068|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767069|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767070|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2767071|NCT00760617|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2767072|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2767073|NCT00760617|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2767074|NCT00760617|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
2767124|NCT00760383|Primary|Stair Time up||6 weeks||||seconds||Standard Error|Mean
2767075|NCT00760578|Post-Hoc|Change From Baseline in Insulin|Change from Baseline in insulin levels following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 pre-dose laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||uIU/mL||Standard Error|Least Squares Mean
2767076|NCT00760578|Post-Hoc|Change From Baseline in FPG|Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had Day 8 and Day 43 fasting plasma glucose values. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
2767077|NCT00760578|Secondary|Change From Baseline in HDL|Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
2767078|NCT00760578|Secondary|Change From Baseline in Triglycerides|Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
2767079|NCT00760578|Secondary|Change From Baseline in FFAs|Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment|After 28 days of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
2767080|NCT00760578|Secondary|Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test|Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.|After four weeks of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||uIU/mL||Standard Error|Least Squares Mean
2767081|NCT00760578|Primary|Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test|Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
2767082|NCT00760552|Primary|Blood Pressure Change|Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint—BP—will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).|Measured at Baseline, and 6,12,18,24, and 30 months post baseline.||||mmHg||Standard Deviation|Mean
2767083|NCT00760526|Secondary|Parental Quality of Life Measures: CGM Satisfaction Scale|"Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)~JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684"|26 weeks||||units on a scale||Standard Deviation|Mean
2767084|NCT00760526|Secondary|Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month.|26 weeks||||units on a scale||Standard Deviation|Mean
2767085|NCT00760526|Secondary|Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)|The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.|26 weeks||||units on a scale||Standard Deviation|Mean
2767086|NCT00760526|Secondary|Parental Quality of Life Measures: Hypoglycemia Fear Survey|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks.|26 weeks||||units on a scale||Standard Deviation|Mean
2767087|NCT00760526|Secondary|Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)|Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||percentage of median||Inter-Quartile Range|Median
2767125|NCT00760266|Secondary|Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8|Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg|At Weeks 4 and 8|Full analysis set|||Percentage of Participants|||Number
2767088|NCT00760526|Secondary|Measures of Variability: Mean Absolute Rate of Change|mean absolute rate of change|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||mg/dL per minute||Inter-Quartile Range|Median
2767089|NCT00760526|Secondary|Measures of Variability: Standard Deviation (SD)|standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|||mg/dL||Inter-Quartile Range|Median
2767090|NCT00760526|Secondary|Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|26 weeks||||percentage of sensor readings||Inter-Quartile Range|Median
2767091|NCT00760526|Secondary|CGM Glucose Values (mg/dL)|Percentage of sensors values in range (71 mg/dL to 180 mg/dL)|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||percentage of sensor readings||Inter-Quartile Range|Median
2767092|NCT00760526|Secondary|Number of Severe Hypoglycemic Events Experienced by Participants||26 weeks|Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.|||events|||Number
2767093|NCT00760526|Primary|Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events||26 weeks|Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models|||participants|||Number
2767094|NCT00760513|Primary|NAFLD Fibrosis Score|The NAFLD fibrosis score represented a validated algorithmically-derived measure of liver fibrosis as reported in Angulo et al (see reference section). The Score is derived from anthropometric and biochemical measurements in subjects. The NAFLD fibrosis score represents an arbitrary number with no units from -5.0 to +5.0. High positive NAFLD fibrosis scores indicate a high probability of advanced liver fibrosis. Negative scores represent a low probability of advanced liver fibrosis. The change in NAFLD fibrosis score (measured in arbitrary units) was used to test the effect of the intervention and represented the arithmetic difference in the end minus baseline measurements of this score. Thus, a negative change in the Score in the Table represented an improvement in liver fibrosis score between baseline and the end of the study. A positive change in the Score in the Table represented a worsening in liver fibrosis score between baseline and end of the study.|Baseline and 18 months|Participants with baseline and end of study data.|||score on a scale||Standard Deviation|Mean
2767095|NCT00760513|Primary|Liver Fibrosis Score|The Liver Fibrosis Score is an algorithmically derived score of liver fibrosis comprising measurements of tissue matrix metalloproteinase-1 (TIMP-1), hyaluronic acid (HA) and the amino terminal end of procollagen III (PIIINP) (see Guha et al. in Reference section). The Score represents a number on a numerical scale from 0 to 20. High values of the score (measured in arbitrary units) indicate high probability of advanced liver fibrosis, low scores indicate low probability of advanced liver fibrosis. Change in Liver Fibrosis Score was used to test the intervention. Change in liver fibrosis score represented the change in measurement as calculated as the arithmetic difference between the end value minus the baseline value of the Liver Fibrosis Score. The change in Liver Fibrosis Score can therefore be negative (representing an improvement in liver fibrosis between baseline and end of study) or be positive, (representing a worsening a liver fibrosis between baseline and end of study.|Baseline and 18 months|Participants with baseline and end of study data|||score on a scale||Standard Deviation|Mean
2767096|NCT00760513|Primary|Percentage of Liver Fat|Percentage of liver fat was measured using magnetic resonance spectroscopy at baseline and end of study. High percentage values indicate a lot of liver fat (scale from 0 to 100%). Change in liver fat percentage represented the arithmetical difference between end of study liver fat percentage minus baseline measurement of liver fat percentage change in liver fat percentage was used to test whether the intervention decreased liver fat percentage. A negative change value in liver fat percentage indicates a response to therapy. A positive change value indicates no response to therapy.|Baseline and 18 months||||percentage of liver fat||Standard Deviation|Mean
2767097|NCT00760487|Secondary|IOL Rotation|Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.|6 months post-operative||||Percentage of Participants|||Number
2767098|NCT00760487|Secondary|Spectacle Independence|Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit|6 months post-operative||||Percentage of participants|||Number
2767099|NCT00760487|Primary|Visual Acuity (VA)|"Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA)."|Pre-operative, 1 month, 3 month, and 6 month post-operative||||logMAR||Standard Deviation|Mean
2767100|NCT00760474|Secondary|Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria|Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure.|Day 58|FAS; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
2767101|NCT00760474|Secondary|Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked|"BP cuff evoked allodynia assessed based on participant response to the following question When I take your blood pressure, tell me if the cuff's pressure is painful. A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments."|Day 58|FAS; N=number of participants with analyzable data at observation.|||mm Hg||Standard Deviation|Mean
2767102|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
2767103|NCT00760474|Other Pre-specified|Pain Catastrophizing Scale (PCS) Including Outliers|"PCS is a participant rated 13-item instrument to measure the presence and severity of catastrophizing. Scored 0 (not at all) to 4 (all the time) to statements such as When I'm in pain…I worry all the time about whether the pain will end. All 13 statements start with When I'm in pain…. Total score ranged from 0 to 52; higher scores reflected greater impairment. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier."|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767104|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
2767105|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
2767106|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767107|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767108|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767109|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767110|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767111|NCT00760474|Secondary|Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers|Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767112|NCT00760474|Secondary|Gracely Box Scales for Pain Intensity (GBSint) Including Outliers|Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
2767113|NCT00760474|Secondary|Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions|Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Participants in FAS with quality resting state data (data able to be corrected for motion [head and cardiorespiratory artifacts]).|||z-score||Standard Deviation|Mean
2767114|NCT00760474|Secondary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS.|||percent change in BOLD signal||Standard Deviation|Mean
2767115|NCT00760474|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC).|||percent change||Standard Error|Least Squares Mean
2767116|NCT00760474|Primary|Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)|Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation.|||ratio||Standard Deviation|Mean
2767117|NCT00760461|Primary|Gastroparesis Cardinal Symptom Index||upon study completion|Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.||||||
2767118|NCT00760435|Secondary|Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm|left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area|2 weeks||||Z-score||95% Confidence Interval|Mean
2767119|NCT00760435|Secondary|Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.||24 hours||||mg/dL||95% Confidence Interval|Mean
2767120|NCT00760435|Secondary|Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)||up to 6 weeks||||days||Inter-Quartile Range|Median
2767121|NCT00760435|Primary|The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion||10 weeks|1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo)|||participants|||Number
2767122|NCT00760383|Secondary|Mid-thigh Muscle Volume|Analysis was performed using the Analyze 11 software package with semi-automated delineation of quadriceps, hamstrings, and adductors boarders. Using thresholding methods, the software can differentiate operator-delineated parameters set to distinguish muscle from non-muscle (i.e., adipose tissue) using voxel intensity within each border region for quantitative determination of muscle volume.|6 weeks||||Volume (cm^3)||Standard Error|Mean
2767123|NCT00760383|Primary|Quadriceps Muscle Strength||6 weeks||||Newtons||Standard Error|Mean
2767130|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767131|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767132|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767133|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767134|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767135|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767136|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767137|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767138|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767139|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2767140|NCT00760214|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2767141|NCT00760214|Primary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2767142|NCT00760084|Primary|The Number of Subjects With Adverse Events|Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).|3 months||||participants|||Number
2767143|NCT00760019|Primary|Flow-mediated, Endothelium-dependent Vasodilation|Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.|Upon completion of 4 weeks of salsalate and placebo treatment|The ultrasound data for two subjects was inadequate for analysis. This determination was made prior to unblinding. The data for these two subjects were discarded, leaving 56 subjects for analysis.|||percentage vasodilation||Inter-Quartile Range|Median
2767144|NCT00760006|Primary|Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty|Primary outcomes of fistula or delayed wound healing following palatoplasty were measured in two groups of patients. This outcome measure addresses both objectives noted in the summary of the study description.|We anticipate a minimum of less than 2 months to a maximum of 1 year for follow-up will be necessary to document either stage 1 healing or the presence of a palatal fistula in nearly all cases.|"Only participants receiving preoperative antibiotics are considered for this outcome measure. Please refer to the exclusion criteria listed in the initial protocol -- Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or placebo groups."|||Participants|||Count of Participants
2767145|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation||once the final participant has completed all intervention procedures, approx. 3 months||||pg/mL||Inter-Quartile Range|Median
2767146|NCT00759967|Secondary|To Determine Patient Modality Preference.|each participant will complete a questionaire regarding modality preference|at study completion|The trial did not include a questionnaire regarding modality preference as originally planned||||||
2767147|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress.||once the final participant has completed all intervention procedures, approx. 3 months||||mmol/ml MDA equivalent||Inter-Quartile Range|Median
2767148|NCT00759967|Secondary|To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis|Serum phosphate values from the end of the three month run in phase and after randomization used to measure metabolic homeostasis|once the last participant has completed run in phase and after randomization, approx. 3 months||||mmol/Litre||Standard Deviation|Mean
2767149|NCT00759967|Secondary|To Determine if the Mechanism by Which Short Daily Hemodialysis is Associated With Changes in Extracellular Fluid Volume|The extracellular fluid volume will be measured using bioelectrical impedance to determine if the mechanism by which short daily hemodialysis is associated with an improvement in blood pressure control is secondary to changes in extracellular fluid volume.|once the final participant has completed all intervention procedures, approx. 3 months||||Litres||Standard Deviation|Mean
2767150|NCT00759967|Primary|Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm|The average of 2 measurements taken pre each dialysis session in the third month of treatment were compared when the patients were on conventional hemodialysis compared to short daily hemodialysis. SBP was taken in accordance with guidelines from the Canadian Hypertension Society|Average of the last month of the 3 month intervention||||mm Hg||Standard Deviation|Mean
2767151|NCT00759954|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose||||ng*hr/mL||Standard Deviation|Mean
2767152|NCT00759954|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng*hr/mL||Standard Deviation|Mean
2767153|NCT00759954|Secondary|Time of Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|Subjects completed the study without protocol violations.|||hour||Full Range|Median
2767154|NCT00759954|Primary|Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
2767155|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months|Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
2767156|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
2767157|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
2767158|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
2767159|NCT00759915|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
2767160|NCT00759915|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
2767161|NCT00759915|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||Hr||Full Range|Median
2767162|NCT00759915|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||ng/mL||Standard Deviation|Mean
2767163|NCT00759902|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
2767164|NCT00759902|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
2767165|NCT00759902|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr||Full Range|Median
2767167|NCT00759863|Secondary|Center for Epidemiologic Studies Depression Scale|The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.|6 months||||Units on a scale||Standard Deviation|Mean
2767168|NCT00759863|Secondary|Revised Memory and Behavior Problems Checklist|"This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this bothered or upset them. A conditional bother score is calculated which is the upset or bother ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96."|6 months||||Units on a scale||Standard Deviation|Mean
2767169|NCT00759863|Primary|Multidimensional Observation Scale for Elderly Subject|"This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: Personal Care, Communication, Awareness & Memory, Mood, and Interpersonal Awareness Behaviors. The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144."|6 months||||Units on a scale||Standard Deviation|Mean
2767170|NCT00759811|Secondary|Incidence of Adverse Effects of the Treatment||12 weeks|||||||
2767171|NCT00759811|Secondary|Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need||12 weeks|||||||
2767172|NCT00759811|Secondary|Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels||12 weeks|||||||
2767173|NCT00759811|Secondary|Improve in Quality of Life Measured Using the Brazilian Edition SF-36||12 weeks|||||||
2767174|NCT00759811|Secondary|Improve in Heart Failure Functional Class Measured Using New York Heart Association||12 weeks|||||||
2767175|NCT00759811|Primary|Change in Physical Capacity Measured Using the 6-minute Walk Test Distance|The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).|Baseline and 12 weeks||||meters||Standard Deviation|Mean
2767176|NCT00759785|Secondary|Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab|IGF1R expression was measured in pre and post-dose biopsy samples using an immunohistochemistry assay. Results were expressed as an IGF1R membrane H-score. The H-score was calculated from the percentage of cells staining very weak (+/-); weak (1+); moderate (2+); or strong (3+) and obtained by the formula: (3 x percentage of strongly staining nuclei) + (2 x percentage of moderately staining nuclei) + (1 x percentage of weakly staining nuclei) + (0.5 x percentage of weakly staining nuclei). The H-score ranges from 0 to 300; with a score of 0 representing the absence of IGF1R expression and an H-score of 300 representing maximum IGF1R expression. A decrease in IGF1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement|Baseline and Up to 12 Days|All participants who received a single dose of dalotuzumab, had evaluable baseline and post-dose biopsy samples, and had H-score data available for pre- and post-dose measurements.|||H-score||Full Range|Mean
2767177|NCT00759785|Secondary|Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort|Biopsy samples were considered IGF1R negative if less than 10% of tumor cells stain. GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R negative at baseline, and had evaluable postdose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
2767178|NCT00759785|Secondary|Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort|Insulin-like Growth Factor Receptor Type 1 (IGF1R) expression was measured in pre-dose biopsy samples using an immunohistochemistry assay to establish baseline IGF1R positivity. Biopsy samples were considered IGF1R positive if at least 10% of tumor cells stain with intensity 1+ or greater based on staining criteria of very weak (+/-); weak (1+); moderate (2+); or strong (3+). GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R positive at baseline, and had evaluable postdose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
2767179|NCT00759785|Primary|Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)|GFS was measured by microarray analysis of the entire 101 gene signature expression. The GFS is quantified as the change in gene expression between two separate samples collected from the same participant. A log (base 10) ratio of expression in the post-dose sample was generated relative to the reference in both the Up and DOWN arms of the gene signature. A log ratio value of zero indicated no change in the expression between the two samples. GFS was calculated as the mean log ratio of genes in the UP arm minus mean log ratio of genes in the Down arm. GFS was compared for paired samples (pre-dose and post-dose) by a T-statistic calculated as the GFS divided by its standard error. Responders to therapy had a T-statistic that was smaller than the threshold 1st percentile of student's T-distribution and were counted as having a decrease in GFS.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab and had evaluable baseline and post-dose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
2767180|NCT00759772|Primary|Percent Change in Lumbar Spine Bone Mineral Density|Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)|Baseline and 6 months|All participants were included in analysis (intention to treat).|||percentage of change||Standard Error|Mean
2767181|NCT00759759|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
2767182|NCT00759759|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
2767183|NCT00759759|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr||Full Range|Median
2767185|NCT00759707|Primary|Change From Baseline in Saphenous Vein Bypass Graft Vasodilation|Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.|Single visit study||||vein bypass graft size increase (%)||Standard Error|Mean
2767186|NCT00759681|Primary|Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response|The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.|Treatment through 6 weeks|Based on ITT population for primary safety analysis.|||participants|||Number
2767187|NCT00759681|Primary|Immediate Sealing Evidenced by no Bleeding on Clamp Release.|The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery|Immediate at time of surgery|Treatment sites were the unit of measure based on ITT for effectiveness outcomes.|||Treatment sites|Participants||Number
2767188|NCT00759668|Primary|Near Uncorrected Visual Acuity Right Eye (UCVA RE)|"Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
2767189|NCT00759668|Primary|Near Best Corrected Visual Acuity Right Eye (BCVA RE)|"Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
2767190|NCT00759668|Primary|Near Uncorrected Visual Acuity Left Eye (UCVA LE)|"Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
2767191|NCT00759668|Primary|Near Best Corrected Visual Acuity Left Eye (BCVA LE)|"Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
2767192|NCT00759668|Primary|Near Uncorrected Visual Acuity (UCVA) Binocular|"Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
2767204|NCT00759577|Primary|Improvement in Patient Perception of Bladder Condition Score (PPBC)|Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.|12 weeks|There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.||||||
2767193|NCT00759668|Primary|Near Best Corrected Visual Acuity (BCVA) - Binocular|"Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
2767194|NCT00759655|Secondary|Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds|The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed).|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Bleeds|Participants|Standard Deviation|Mean
2767195|NCT00759655|Secondary|Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver|A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions).|Baseline to 24 months or early withdrawal|The study was terminated, analysis was not conducted.|||Scores on scale|||Number
2767196|NCT00759655|Secondary|Number of Xyntha Infusions Needed to Treat Each New Bleed|The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial 'for a new bleed' (on demand) infusion to any subsequent (on demand) infusions for the (same) 'previously treated bleed'. An on-demand infusion for a 'previously treated bleed' was counted toward the bleed with the most recent start time prior to that infusion.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Infusions|Participants||Number
2767197|NCT00759655|Secondary|Mean Annualized Bleed Rate (ABR)|An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Number of Bleeds|Participants|Standard Deviation|Mean
2767198|NCT00759655|Primary|Percentage of Participants With Low Recovery LETE|The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of participants|||Number
2767199|NCT00759655|Primary|Percentage of Participants With LETE in the Prophylaxis Setting|The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of participants|||Number
2767200|NCT00759655|Primary|Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting|"LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive No Response ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor."|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of Participants|||Number
2767201|NCT00759655|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay.|Baseline to 24 months or early withdrawal.|Intent-to-treat (ITT) population: Participants who had received at least 1 dose of Xyntha.|||Percentage of participants|||Number
2767202|NCT00759642|Primary|Progression Free Survival|Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.|12 months||||months||80% Confidence Interval|Median
2767203|NCT00759603|Primary|Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines|Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly & constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes>1500/µL, platelets>100,000/µL, hemoglobin>11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate & biopsy normocellular for age with <30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia & bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, &/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets>100,000/µL or 50% improvement; Hemoglobin>11.0 g/dL (untransfused) or 50% improvement.|Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.||||Percentage of Participants|||Number
2767854|NCT00754572|Secondary|Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
2767205|NCT00759564|Secondary|Number of Participants With Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline, 7-10 days after the last dose of study drug|Safety analysis set included all participants who received the study medication.|||participants|||Number
2767206|NCT00759564|Secondary|Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for abnormal ECG (12-lead) values were defined as: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent for baseline value of >200 msec and >=50% for baseline value of <=200 msec for PR interval, QRS interval >=200 msec; QT interval corrected using the Fridericia formula (QTcF) >=500 msec or increase of >45 msec.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
2767207|NCT00759564|Secondary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg, >=20 mmHg maximum increase and decrease from baseline in same posture, heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
2767208|NCT00759564|Secondary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 6/High Power Field [HPF]).|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
2767209|NCT00759564|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
2767210|NCT00759564|Secondary|Concentration Versus Time Summary of Plasma Formate|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
2767211|NCT00759564|Secondary|Concentration Versus Time Summary of 2-Ethylbutyric Acid|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
2767212|NCT00759564|Secondary|Pharmacokinetics of CP-70429 and PF-03709270 Metabolites|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429 and metabolites.|0.5, 2, 4, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|Data was not collected for this outcome because the metabolite data for CP-70,429 and PF-03709270 were not analyzed as per change in planned analysis||||||
2767213|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2767214|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 1.0 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 1.0 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2767215|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2767216|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 microgram per milliliter (mcg/mL) at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2767217|NCT00759564|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCinf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2767218|NCT00759564|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2767219|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
2767220|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
2767221|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following PF-03709270 Oral Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
2767222|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2767223|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2767224|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2767276|NCT00759031|Primary|Gingival Margin Plaque Index|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.|1 day||||Units on a scale||Standard Deviation|Mean
2767225|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2767226|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following CP-70,429 Intravenous Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||liter per hour (L/hr)||Standard Deviation|Geometric Mean
2767227|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2767228|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2767229|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2767230|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2767231|NCT00759525|Primary|Forearm Blood Flow|At the end of each 14-day intervention (Glycyrrhinitic acid or Placebo), vascular endothelial function was assessed by measuring forearm blood flow and comparing to Baseline. The outcome measure depicted below reflects the change in forearm blood flow from Baseline after completing the glycyrrhinitic acid regimen as well as the change in forearm blood flow from Baseline after taking the matching placebo.|Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)||||ml/100ml of tissue/min||Standard Error|Mean
2767232|NCT00759473|Primary|Subjective Craving of Cocaine|Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).|two weeks|Data of participants who completed all cue exposure sessions and the one-week follow-up were analyzed.|||units on a scale||Standard Deviation|Mean
2767233|NCT00759408|Secondary|Cardiac Output (CO)|CO will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||l/min||Standard Error|Mean
2767234|NCT00759408|Secondary|Mean Pulmonary Artery Pressure (PAP)|PAP will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||mmHg||Standard Error|Mean
2767235|NCT00759408|Secondary|Systemic Vascular Resistance (SVR)|SVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||dyn*sec/cm^5||Standard Error|Mean
2767236|NCT00759408|Primary|Pulmonary Vascular Resistance (PVR)|PVR will be measured at these 5 time points: 1) Baseline, 2) Hypoxia induced and maintained for 15 min post-baseline at which time the measurement is taken again, 3) Baseline oxygen saturation (Normoxia) reestablished 15 min post-hypoxia period, at which time the measurement is taken again 4) Normoxia measurement taken after BQ-123 administered for 60 min after time point 3, 5) Hypoxia induced and maintained for 15 min after BQ-123 normoxia period, at which time the measurement is taken again.|Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)|Only 19 healthy volunteers completed the study. The study was closed before the 19 patients with established pulmonary hypertension could have data collected.|||dyn*sec/cm^5||Standard Error|Mean
2767237|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.|"Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score.~The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome."|Randomization to week 4||||Participants|||Number
2767238|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.|"Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Randomization to week 4||||Participants|||Number
2767239|NCT00759395|Secondary|Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).|"Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Week 4||||Units on a scale||Standard Error|Least Squares Mean
2767240|NCT00759395|Primary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score.|The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.|Week 4||||Units on a scale||Standard Error|Least Squares Mean
2767241|NCT00759395|Primary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Week 4||||Units on a scale||Standard Error|Least Squares Mean
2767242|NCT00759356|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
2767243|NCT00759356|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
2767244|NCT00759356|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr||Full Range|Median
2767245|NCT00759356|Primary|Mean Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
2767246|NCT00759330|Secondary|Patient Assessment of Wearability of Therapy|"At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where:~1 = Excellent, 4 = Poor."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||participants|||Number
2767247|NCT00759330|Secondary|Percentage of Patients Who Discontinued|The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.|Days 1 through Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||percentage of patients who discontinued|||Number
2767248|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The total amount (mg) of rescue medication used during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||mg||Standard Error|Least Squares Mean
2767249|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The percentage of patients who used rescue medication during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||percentage of patients|||Number
2767250|NCT00759330|Secondary|Patient Global Impression of Change (PGIC)|"At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where:~1 = very much improved, 7 = very much worse."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||participants|||Number
2767272|NCT00759109|Secondary|Number of Participants With Development of Hepatic Decompensation|The development of hepatic decompensation, defined as worsening of the hepatic function as measured by Child Pugh Score. The Child Pugh score was calculated based on biochemical changes (changes in serum albumin, serum bilirubin, prothrombin time) and clinical impairment (ascites, encephalopathies) or both. Each of the 5 parameters was scored from 1-3, and the Child Pugh Score represented the total score. The maximum score was 15, and a score of 10-15 represents the worst outcome and a life expectancy of 1-3 years.|Baseline, During 3 years of treatment and 2 years of follow-up|ITT population|||Participants|||Number
2767251|NCT00759330|Secondary|Change From Baseline in Total Tender Point Examination Score|"At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where:~0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect."|Baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||units on a scale||Standard Error|Least Squares Mean
2767252|NCT00759330|Secondary|Percent Change From Baseline in Total Functional Rating Index (FRI)|"Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome.~FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where:~Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100.~A positive percent change indicates a favorable treatment effect."|baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||percent change from baseline||Standard Error|Least Squares Mean
2767253|NCT00759330|Secondary|Average Daily Categorical Pain Scale Scores|"Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where:~0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time.~Data are reported as the daily average categorical pain scale score by treatment group."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Deviation|Mean
2767254|NCT00759330|Secondary|Pain Intensity Difference (PID+)|"+PID = pre-treatment value at baseline - post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~A positive PID indicates a reduction in pain."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Error|Least Squares Mean
2767255|NCT00759330|Primary|Cumulative Summed Pain Intensity Difference (SPID+)|"The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient."|Days 4 and 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Error|Least Squares Mean
2767256|NCT00759187|Primary|Dental Plaque Index|Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)|4-Day||||Units on a scale||Standard Deviation|Mean
2767257|NCT00759174|Other Pre-specified|Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.|60-day period prior to onset of NAION symptoms|FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset.|||exposed weeks|Participants||Number
2767258|NCT00759174|Other Pre-specified|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.|||exposed days|Participants||Number
2767273|NCT00759109|Primary|Number of Participants With the Development of Hepatocellular Carcinoma (HCC)|"Participants were tested for focal lesions by liver ultrasound and for AFP levels every 6 months the during study (treatment and follow-up).~The development of hepatocellular carcinoma was determined by:~the appearance of a focal lesion detected by liver ultrasound with metastases confirmed by fine needle biopsy, or~the appearance of a focal lesion detected by ultrasound + alphafetoprotein (AFP) levels in blood >400 ng/mL."|During 3 years of treatment and 2 years of follow-up|ITT population|||Participants|||Number
2767259|NCT00759174|Primary|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.|||exposed days|Participants||Number
2767260|NCT00759161|Secondary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.|Day 7,14, 21, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2767261|NCT00759161|Secondary|Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35|Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2767262|NCT00759161|Secondary|Change From Baseline in Scaling at Day 7,14, 21, 28 and 35|Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2767263|NCT00759161|Secondary|Change From Baseline in Erythema at Day 7,14, 21, 28 and 35|Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2767264|NCT00759161|Secondary|Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2767265|NCT00759161|Primary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.|Day 28|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2767266|NCT00759148|Secondary|Microbiological Success at the Day 4 (EOT)/Exit Visit|Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.|Day 4|MBITT Analysis Set|||percentage of subjects|||Number
2767267|NCT00759148|Primary|Clinical Cure at the Day 4 (EOT)/Exit Visit|Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.|Day 4|This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).|||percentage of subjects|||Number
2767268|NCT00759109|Other Pre-specified|Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI) at Baseline|Liver tissues obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome.|Baseline|ITT population|||Score on a scale||Standard Deviation|Mean
2767269|NCT00759109|Secondary|Change in the Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI)|"PCNA-LI was measured at baseline and at 18 months of treatment, and the change in PCNA-LI was calculated.~To measure PCNA-LI, liver tissue samples obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome."|Baseline and at 18 months of treatment|Participants with tissue biopsies at 18 months.|||Score on a scale||Standard Deviation|Mean
2767270|NCT00759109|Secondary|Number of Patients With a Virological Response Rate|"Virological Response rate was measured by the disappearance of Hepatitis C Virus from serum. Serum samples from participants were analyzed for the~presence of HCV-RNA using a qualitative polymerase chain reaction (PCR)."|Baseline and every year during 3 years of treatment|ITT population|||Participants|||Number
2767271|NCT00759109|Secondary|Survival Time of Participants|Survival time was defined as time from screening visit to the death of the participant and was studied with Kaplan-Meier and Log-rank tests. If a participant did not die, he or she was censored with the last available date.|During 3 years of treatment and 2 years of follow-up|ITT population|||Years||95% Confidence Interval|Median
2767277|NCT00758862|Primary|Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used|"The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
2767278|NCT00758862|Primary|Area Under the Curve by SIRS Score|"On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s).~The severity was to be recorded using the Severity of Infection Rating Scale (SIRS).~For the SIRS, the following seven clinical signs/symptoms of infection were assessed:~Exudates/pus, Crusting, Erythema, Oedema, Tissue warmth, Itching and Pain.~Each of the seven signs/symptoms was scored using the following scale:~0 = absent 2 = mild 4 = moderate 6 = severe~The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
2767279|NCT00758862|Primary|Area Under the Curve by Baseline Lesion Size|"On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm².~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
2767280|NCT00758862|Primary|Area Under the Curve (AUC(0-t))|"Area under the concentration-time curve (AUC(0-t)) from time 0 to time of last non-zero observation after dosing, calculated by linear/log trapezoidal method.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
2767281|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
2767282|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
2767283|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
2767284|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax )|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
2767285|NCT00758862|Primary|Peak Serum Concentration by Amount of TD1414 Cream Used|"The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
2767286|NCT00758862|Primary|Peak Serum Concentration by SIRS Score|"On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s).~The severity was to be recorded using the Severity of Infection Rating Scale (SIRS).~For the SIRS, the following seven clinical signs/symptoms of infection were assessed:~Exudates/pus Crusting Erythema Oedema Tissue warmth Itching Pain~Each of the seven signs/symptoms was scored using the following scale:~0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
2767287|NCT00758862|Primary|Peak Serum Concentration by Baseline Lesion Size|"On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². The Cmax is presented by baseline lesion size category (≤15 cm² and >15 cm²).~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
2767288|NCT00758862|Primary|Peak TD1414 Serum Concentration (Cmax )|"The Cmax was summarised by lesion size at baseline, by SIRS scores at baseline and by amount of TD1414 cream used.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. For description of lesion size, SIRS score and amount of TD1414 cream used please see outcome measure 3, 4 and 5 respectively."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
2767301|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
2767289|NCT00758862|Primary|TD1414 Serum Concentration by Timepoint|On Days 1 and 2(and possibly Day 3 depending on the time of first application on Day 1) a sample was taken for pharmacokinetic(PK) analysis at any time before first application on Day 1, and at 12±1, 18±1, 24±1 and 36±4 hours after first application. If the 36±4 hours sampling time fell on Day 3, then a second sample was also required on Day 3, but was to be obtained at 6pm or afterwards. On Days 3 to 6(and also Day 7 if the very last application fell on Day 8), one sample was taken on each day at any time during the day. On Days 7 and 8(or Days 8 and 9 if very last application was on Day 8), a sample was taken immediately before the very last application and at 6±1, 12±1 and 24±2 hours after the very last application. On Days 9 and 10, one sample was taken on each day at any time during the day. If the participant had already had a sample(s) taken on Day 9 because the timing of some of the post-last application samples fell on this day, then further samples were not required on Day 9|From 0 hours to 240 hours|One participant withdrew at day 3 due to the participant being out of range of the inclusion criterion.|||pg/mL||Standard Deviation|Mean
2767290|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 14 days post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).|||participants|||Number
2767291|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 48 hours post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).|||Participants|||Number
2767292|NCT00758836|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose.|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).|2 hours post-dose|The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.|||Percentage of Participants|||Number
2767293|NCT00758836|Primary|Percentage of Participants With Pain Freedom at Two Hours Post-dose|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).|2 hours post-dose|The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.|||Percentage of Participants|||Number
2767294|NCT00758771|Primary|Shear Rheology|Baseline measure of sputum shear rheology|Cross-sectional||||Pascal||Standard Error|Mean
2767295|NCT00758758|Primary|Neck Disability Index (NDI)|"The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.~NDI scoring:~0 - 4 = No disability~5 - 14 = Mild disability~15 - 24 = Moderate disability~25 - 34 = Severe disability~35 or over = Complete disability"|12 Months||||units on a scale||Standard Deviation|Mean
2767296|NCT00758758|Primary|Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)|Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months|12 Months||||participants|||Number
2767297|NCT00758745|Primary|Posterior Capsule Opacification (PCO)|Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.|Up to 3 years||||Units on a scale||Standard Deviation|Mean
2767298|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
2767299|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
2767300|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
2767902|NCT00754494|Secondary|Number of Participants Reported at Least 1 Rash Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks||||participants|||Number
2767302|NCT00758706|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ) Total|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Baseline and Week 6|Full analysis set|||Score on scale||Full Range|Mean
2767303|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||L/min||Full Range|Mean
2767304|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||L/min||Full Range|Mean
2767305|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) 25−75% at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L/s||Full Range|Mean
2767306|NCT00758706|Secondary|Change From Baseline in Inspiratory Capacity (IC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
2767307|NCT00758706|Secondary|Change From Baseline in Vital Capacity (VC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
2767308|NCT00758706|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
2767309|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
2767310|NCT00758706|Secondary|Incidence of Adverse Events|Number of patients who had an AE|all study visits||||Participants|||Number
2767311|NCT00758706|Primary|Ratio of Total Urine Desmosine at Week 6 to Baseline|Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
2767312|NCT00758706|Primary|Ratio of Sputum Total Cells at Week 6 to Baseline|Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
2767313|NCT00758706|Primary|Ratio of TNF Alpha at Week 6 to Baseline|Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
2767314|NCT00758680|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug|||participants|||Number
2767315|NCT00758680|Secondary|Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)|Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).|Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)|Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.|||mg/dL||Standard Deviation|Least Squares Mean
2767316|NCT00758680|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug|||participants|||Number
2767317|NCT00758667|Secondary|Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care||one year||||participants|||Number
2767318|NCT00758667|Primary|Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care||one year||||participants|||Number
2767319|NCT00758602|Secondary|Glomerular Filtration Rate (GFR) (mL/Min)|The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
2767320|NCT00758602|Secondary|Serum Creatinine (Micromoles Per Liter [µmol/L])|The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.|||µmol/L||Standard Deviation|Mean
2767322|NCT00758602|Secondary|Percentage of Participants With Treatment Failure at 12 Months Post-Transplant|Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.|Month 12|ITT population|||percentage of participants|||Number
2767323|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant|The median time, in days, between randomization and acute rejection.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population|||days||95% Confidence Interval|Median
2767324|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant - Number of Participants With an Event||BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population|||participants|||Number
2767325|NCT00758602|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant||Months 6 and 12|ITT population|||percentage of participants|||Number
2767326|NCT00758602|Primary|Glomerular Filtration Rate (GFR) at Month 12 After Transplantation|GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].|Month 12|ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.|||mL/min||Standard Deviation|Mean
2767327|NCT00758602|Primary|Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation|CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.|Month 12|ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.|||score on a scale||Standard Deviation|Mean
2767328|NCT00758589|Secondary|Adverse Event (AE)|Number of patients reporting at least one event|4 weeks||||Participants|||Number
2767329|NCT00758589|Secondary|Asthma Control Questionnaire 5 Items (ACQ5)|Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
2767330|NCT00758589|Secondary|Forced Vital Capacity (FVC) at the Clinic|Mean FVC during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
2767331|NCT00758589|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at the Clinic|Mean FEV1 during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
2767332|NCT00758589|Secondary|Reliever Free Day|Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
2767333|NCT00758589|Secondary|Symptom Free Day|Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
2767334|NCT00758589|Secondary|Asthma Control Day|Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
2767335|NCT00758589|Secondary|Awakenings|Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
2767336|NCT00758589|Secondary|Day-time Asthma Symptom Score|Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Standard Deviation|Mean
2767337|NCT00758589|Secondary|Night-time Asthma Symptom Score|Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Standard Deviation|Mean
2767338|NCT00758589|Secondary|Total Use of Reliever|Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Number of inhalations per day||Standard Deviation|Mean
2767339|NCT00758589|Secondary|Evening Forced Expiratory Volume in 1 Second (eFEV1)|Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
2767340|NCT00758589|Secondary|Morning Forced Expiratory Volume in 1 Second (mFEV1)|Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
2767341|NCT00758589|Secondary|Evening Peak Expiratory Flow (ePEF)|Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Standard Deviation|Mean
2767342|NCT00758589|Primary|Morning Peak Expiratory Flow (mPEF)|Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Standard Deviation|Mean
2767343|NCT00758576|Primary|Uncorrected Near Visual Acuity|Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
2767344|NCT00758576|Primary|Uncorrected Distance Visual Acuity|Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
2767345|NCT00758576|Primary|Uncorrected Intermediate Visual Acuity|Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
2767346|NCT00758563|Primary|Mean Gingival Plaque Units|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).|1 day||||Units on a scale||Standard Deviation|Mean
2767347|NCT00758550|Secondary|Questionnaire Results|Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).|6 Months||||Units on a scale||Standard Error|Mean
2767348|NCT00758550|Primary|Uncorrected Visual Acuity (UCVA)|"Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|6 Months after surgery||||logMAR||Standard Deviation|Mean
2767349|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
2767350|NCT00758498|Secondary|Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Percent||Standard Deviation|Mean
2767351|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
2767352|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
2767353|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.|Day 3|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 3|||Units on a scale||Standard Deviation|Mean
2767354|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.|Day 2|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 2|||Units on a scale||Standard Deviation|Mean
2767355|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.|Day 1|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 1|||Units on a scale||Standard Deviation|Mean
2767356|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.|Endpoint defined as either Day 3 or last observation after baseline|Safety analysis population defined as all subjects who had at least one dose of study drug and one State and Trait Anxiety Inventory Assessment after Baseline|||Units on a scale||Standard Deviation|Mean
2767357|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 3|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
2767358|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 2|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
2767359|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 1|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
2767360|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Baseline|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here."|Baseline, prior to start of study drug dosing|Full analysis set defined as all subjects who received at least one dose of study drug and had a baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2767370|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
2767361|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
2767362|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
2767363|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
2767364|NCT00758498|Secondary|Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline|MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.|Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1||||Minutes||Standard Deviation|Mean
2767365|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here."|Day 3 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2767366|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here."|Day 2 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2767367|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here."|Day 1 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2767368|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here."|Baseline prior to starting study medication|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2767369|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
2767381|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Scores on a Scale||Full Range|Mean
2767371|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
2767372|NCT00758498|Secondary|Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
2767373|NCT00758498|Primary|Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2|"The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
2767374|NCT00758498|Primary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2|MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
2767375|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
2767376|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
2767377|NCT00758485|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)|The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
2767378|NCT00758459|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 6 weeks of treatment||||m||Full Range|Mean
2767379|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings|Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Score on scale||Full Range|Mean
2767380|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Scores on a Scale||Full Range|Mean
2767903|NCT00754494|Secondary|Number of Participants Reported at Least 1 Side Effect During the Study|Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.|Up to 9 weeks||||participants|||Number
2767382|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Score on scale||Full Range|Mean
2767383|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||Score on scale||Full Range|Mean
2767384|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
2767385|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Morning|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
2767386|NCT00758459|Secondary|Forced Expiratory Flow (FEF)25−75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L/s||Full Range|Mean
2767387|NCT00758459|Secondary|Inspiratory Capacity (IC)|Change in IC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
2767388|NCT00758459|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
2767389|NCT00758459|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
2767390|NCT00758459|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in FEV1 from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
2767391|NCT00758459|Primary|Incidence of Adverse Events|Number of patients who had an Adverse Event|all study visits||||Participants|||Number
2767392|NCT00758420|Primary|The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks|The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.|Baseline to 8 weeks||||units on a scale||Standard Error|Least Squares Mean
2767393|NCT00758394|Primary|Dental Plaque Index|plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.|4-Day||||Units on a scale||Standard Deviation|Mean
2767394|NCT00758342|Primary|Mean IOP (Intraocular Pressure)||Screening: Week 12; (At 9 am and 4 pm time points)||||mm Hg (millimeters mercury)||Standard Deviation|Mean
2767395|NCT00758290|Primary|Dental Plaque Index|Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque|4 Day||||Units on a scale||Standard Deviation|Mean
2767396|NCT00758264|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2767397|NCT00758264|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2767398|NCT00758264|Secondary|Number of Subjects Reporting Rash|Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2767399|NCT00758264|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2767400|NCT00758264|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Day 0-30) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2767401|NCT00758264|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 4-day (Days 0-3) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.|||Participants|||Count of Participants
2767402|NCT00758264|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within the 4-day (Days 0-3) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.|||Participants|||Count of Participants
2767403|NCT00758264|Secondary|Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2767404|NCT00758264|Secondary|Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2767405|NCT00758264|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2767406|NCT00758264|Secondary|Anti-protein D (Anti-PD) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2767407|NCT00758264|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes|Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2767408|NCT00758264|Secondary|Opsonophagocytic Titers Against Pneumococcal Serotypes|Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2767409|NCT00758264|Secondary|Cross-reactive Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2767410|NCT00758264|Secondary|Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2767411|NCT00758264|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.|||Titers||95% Confidence Interval|Geometric Mean
2767412|NCT00758264|Primary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.|||Participants|||Count of Participants
2767413|NCT00758264|Primary|Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.|||μg/mL||95% Confidence Interval|Geometric Mean
2767414|NCT00758160|Other Pre-specified|Global Assessment of Satisfaction by Participant|Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767415|NCT00758160|Secondary|Global Assessment of Satisfaction by Parents/Caregivers|Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767416|NCT00758160|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score|CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Participants|||Number
2767417|NCT00758160|Secondary|Clinical Global Impression-Severity (CGI-S) Score|CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767418|NCT00758160|Secondary|Social Adjustment Scale Score for Children and Adolescents (SAICA)|SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.|Baseline, Week 4 and Week 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767419|NCT00758160|Secondary|Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score|Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767420|NCT00758160|Secondary|Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score|Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.|Baseline, Week 4 and 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767421|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.|Baseline and Week 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767422|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.|Baseline and Week 4|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767423|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.|Baseline and Week 8|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
2767424|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.|Baseline and Week 4|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
2767425|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.|Baseline and Week 2|Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
2767426|NCT00758069|Secondary|Change From Baseline in Plasma Glucose|Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
2767427|NCT00758069|Primary|Change From Baseline in 24-hour Weighted Mean Plasma Glucose|Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
2767428|NCT00758043|Secondary|Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments||Week 72|||||||
2767429|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively).||Week 24 or Week 48||||participants|||Number
2767430|NCT00758043|Secondary|Proportion of Enrolled Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up||Week 72|||||||
2767431|NCT00758043|Secondary|Proportion of Randomized Subjects Who Relapse, Defined as Those Who Complete Treatment, Have Undetectable HCV RNA at End of Treatment (EOT; Week 24 or Week 48 Respectively), and Become HCV RNA Detectable During Antiviral Follow-up||Week 24 or Week 28|||||||
2767432|NCT00758043|Secondary|Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment|SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.|12 weeks after last dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
2767433|NCT00758043|Secondary|Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).|Week 4 and Week 12|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
2774152|NCT00711009|Secondary|Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2767434|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at Week 72|SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.|72 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
2767435|NCT00758043|Primary|Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)|SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).|24 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
2767436|NCT00757848|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767437|NCT00757848|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767438|NCT00757848|Secondary|Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767439|NCT00757848|Secondary|Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767440|NCT00757848|Secondary|Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767441|NCT00757848|Secondary|Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767442|NCT00757848|Secondary|Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767443|NCT00757848|Secondary|Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767444|NCT00757848|Secondary|Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767445|NCT00757848|Primary|Cystic Fibrosis Questionnaire (CFQ-R) - Quittner|Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
2767446|NCT00757848|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Signs and Symptoms|||Number
2767447|NCT00757848|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2767448|NCT00757848|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
2767449|NCT00757848|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2767450|NCT00757848|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2767451|NCT00757848|Primary|Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2767452|NCT00757848|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
2767453|NCT00757848|Primary|24-hour Sputum Weight|Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||grams||Standard Error|Least Squares Mean
2767454|NCT00757848|Primary|Sputum Percentage Neutrophil Count|Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||percentage of neutrophils in WBCs||Standard Error|Least Squares Mean
2767455|NCT00757848|Primary|Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
2767456|NCT00757822|Secondary|Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication|Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews.|Post-operative follow-up interviews 24 hr to 6 weeks post surgery||||percent of participants|||Number
2767457|NCT00757822|Secondary|Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting|Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks.|Post operative follow up interviews 24 hrs to 6 wks||||percent of participants|||Number
2767458|NCT00757822|Secondary|Post-operative Antiemetic Use|Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit.|End of surgery to 48 hr post surgery||||percentage of participants|||Number
2767459|NCT00757822|Secondary|Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure|Number of all-cause hospital admissions on day of elective out-patient surgery .|Post-operative Day of Surgery (DOS)||||participants|||Number
2767460|NCT00757822|Secondary|Post-Operative Care Unit Length of Stay (Min)|Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable.|Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)||||minutes||Inter-Quartile Range|Median
2767461|NCT00757822|Primary|Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery|Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.|24-48 hrs post surgery||||percentage of participants|||Number
2767462|NCT00757822|Primary|Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale|"VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting.~VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU."|Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit||||percentage of participants|||Number
2767463|NCT00757822|Primary|Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.|Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)|Per protocol|||percentage of participants|||Number
2767464|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of CD4 cells||Standard Deviation|Mean
2767465|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||cells/uL||Standard Deviation|Mean
2767466|NCT00757783|Secondary|Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.|Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||cells/micro L||Standard Deviation|Mean
2767467|NCT00757783|Secondary|Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.|the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Log10 HIV RNA||Standard Deviation|Mean
2767468|NCT00757783|Secondary|Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)|Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.|||number of participants|||Number
2767469|NCT00757783|Secondary|Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.|Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.|||number of participants|||Number
2767470|NCT00757783|Secondary|Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.|Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.|||HOMA-IR score||Standard Deviation|Mean
2774153|NCT00711009|Secondary|Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
2767471|NCT00757783|Secondary|Change From Baseline in Insulin at Week 12 and 48.|Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.|||IU/mL||Standard Deviation|Mean
2767472|NCT00757783|Secondary|Change From Baseline in Glucose at Week 12 and 48.|Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.|Baseline, Week 12 and 48|Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.|||mg/dL||Standard Deviation|Mean
2767473|NCT00757783|Secondary|Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.|Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ratio||Standard Deviation|Mean
2767474|NCT00757783|Secondary|Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||g/L||Standard Deviation|Mean
2767475|NCT00757783|Secondary|Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||grams per liters (g/L)||Standard Deviation|Mean
2767476|NCT00757783|Secondary|Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
2767477|NCT00757783|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
2767478|NCT00757783|Secondary|Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
2767479|NCT00757783|Primary|Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12|Observed values.|Baseline, Week 12|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||milligram per deciliters (mg/dL)||Standard Deviation|Mean
2767480|NCT00757705|Secondary|Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24|The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767481|NCT00757705|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).|Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.|||Participants|||Number
2767482|NCT00757705|Secondary|Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24|The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.|||Units on a scale||Standard Deviation|Mean
2767483|NCT00757705|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants."|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767484|NCT00757705|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.|||Units on a scale||Standard Deviation|Mean
2767485|NCT00757705|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767486|NCT00757705|Secondary|Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Up to Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.|||Percentage of participants|||Number
2767487|NCT00757705|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767488|NCT00757705|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
2767489|NCT00757666|Secondary|VO2 at Ventilatory Threshold||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
2767490|NCT00757666|Secondary|Exercise Time||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
2767491|NCT00757666|Secondary|Metabolic Chronotropic Relationship (MCR) Slope||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
2767492|NCT00757666|Secondary|Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test|This outcome measure will be compared against baseline.|2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
2767493|NCT00757666|Primary|Mean Change in Functional Capacity (Peak VO2).|"The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.~The mean change in functional capactity will be compared against baseline; changes from baseline will be measured."|1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
2768054|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2767494|NCT00757627|Secondary|Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4|Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)|Baseline and Week 4|Intention to treat (ITT)|||Units on a Scale||Standard Deviation|Mean
2767495|NCT00757627|Secondary|Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4||Baseline and Week 4|Only patients with both baseline and week 4 data were included in this analysis.|||Days||Standard Deviation|Mean
2767496|NCT00757627|Secondary|Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4|TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.|Baseline and Week 4|"22 patients who reported side effects at baseline and week 4 were included in side effect evaluation."|||Units on a Scale||Standard Deviation|Mean
2767497|NCT00757627|Secondary|Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4|BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).|Baseline and Week 4|Only patients with both baseline and week 4 follow up data were included in this analysis.|||Units on a Scale||Standard Deviation|Mean
2767498|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression|Week 4|per protocol|||Percentage of participants|||Number
2767499|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.|Baseline|"Only patients with baseline and week 4 data were included in the analysis.~Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422"|||Percentage of Participants|||Number
2767500|NCT00757627|Primary|"The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 Pain Walking on a Flat Surface at Week 4"|"WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent no pain and 100 represent extreme pain)"|Baseline and end of week 4|"Per protocol (all patients who completed the WOMACpain walking on a flat surface  question at baseline and follow up visit at week 4 will be included for analysis of this endpoint.~Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis."|||Percentage of Participants|||Number
2767501|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.|Week 4|Per Protocol|||Percentage of Participants|||Number
2767502|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.|Baseline|Only patients with baseline and week 4 data were included.|||Percentage of Participants|||Number
2767503|NCT00757627|Secondary|Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4|The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.|Baseline and Week 4|Only patients with baseline and week 4 data were included in this analysis of change|||Units on a Scale||Standard Deviation|Mean
2767504|NCT00757601|Secondary|Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006|The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM.hr||Standard Deviation|Mean
2767505|NCT00757601|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.|||participants|||Number
2767520|NCT00757588|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response|Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.|||Percentage of participants|||Number
2767506|NCT00757601|Secondary|Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||hr||Standard Deviation|Mean
2767507|NCT00757601|Secondary|Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||hr||Full Range|Median
2767508|NCT00757601|Secondary|Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM||Standard Deviation|Mean
2767509|NCT00757601|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006|The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM.hr||Standard Deviation|Mean
2767510|NCT00757601|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.|||participants|||Number
2767511|NCT00757588|Other Pre-specified|Percentage of Participants With Reported and Confirmed Hypoglycemia|Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/|Baseline to Week 52||||Percentage of Participants|||Number
2767512|NCT00757588|Other Pre-specified|Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period|"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4."|Baseline and during and up to 14 days after last dose of study drug (in Week 52)|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
2767513|NCT00757588|Other Pre-specified|Shift in Platelet Counts From Baseline to Selected Visits (LOCF)|Platelet count=value*10^9 c/L|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
2767514|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Heart Rate||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.|||Beats per minute||95% Confidence Interval|Number
2767515|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.|||mm Hg||95% Confidence Interval|Number
2767516|NCT00757588|Other Pre-specified|Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline to Week 52, continuously|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
2767517|NCT00757588|Other Pre-specified|Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)|Absolute lymphocyte count=value*10^3 c/uL|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
2767518|NCT00757588|Other Pre-specified|Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results|"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions."|Baseline to Week 52|Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication.|||Participants|||Number
2767519|NCT00757588|Secondary|Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)|Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.|||Units||Standard Error|Mean
2767522|NCT00757588|Secondary|Change From Baseline in 120-minute PPG Values During an MTT|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.|Baseline to Week 24||||mg/dL||Standard Error|Mean
2767523|NCT00757588|Secondary|Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal|Baseline to Week 24||||mg*min/dL||Standard Error|Mean
2767524|NCT00757588|Primary|Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])|Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods.|||Percentage of change||Standard Error|Mean
2767525|NCT00757484|Secondary|Surgical Time|Length of surgery|January 2007 to January 2008||||minutes||Full Range|Mean
2767526|NCT00757484|Secondary|Percentage of Participants Undergoing Different Types of Anesthesia|Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).|January 2007 to January 2008||||percentage of participants|||Number
2767527|NCT00757484|Secondary|Percentage of Women With Asymptomatic Hypotension|% women with asymptomatic hypotension|1 year||||percentage of participants|||Number
2767528|NCT00757484|Primary|Percentage of Participants Who Underwent Gynecologic Surgery|491 women were included in analysis. Measure is categorized by the type of surgery.|January 2007 to January 2008|491 women were included in analysis.|||percentage of participants|||Number
2767529|NCT00757237|Other Pre-specified|Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)|"Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee.~Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
2767530|NCT00757237|Other Pre-specified|Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)|Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.|Day 0 through Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||events|||Number
2767531|NCT00757237|Other Pre-specified|Total Number of Respiratory Hospitalizations|Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||hospitalizations|||Number
2767532|NCT00757237|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20|This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication's effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.|At Week 20|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||units on a scale||Standard Error|Least Squares Mean
2767533|NCT00757237|Other Pre-specified|Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.|||units on a scale||Standard Error|Least Squares Mean
2767534|NCT00757237|Other Pre-specified|Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.|||Units on a scale||Standard Error|Least Squares Mean
2774154|NCT00711009|Secondary|Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
2767535|NCT00757237|Secondary|Time to First Respiratory Hospitalization|"This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.~Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.~Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
2767536|NCT00757237|Secondary|Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events|"IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.~Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
2767537|NCT00757237|Secondary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months."|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on participants with prior inhaled tobramycin use >= 84 days in the previous 12 months using the ITT analysis set.|||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
2767538|NCT00757237|Secondary|Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on participants with previous inhaled tobramycin use of >= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.|||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
2767539|NCT00757237|Primary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set."|Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
2767540|NCT00757237|Primary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.|||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
2767541|NCT00757172|Secondary|Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution|Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.|Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery|All recruited participants.|||participants|||Number
2767542|NCT00757172|Secondary|Percentage of Participants With 2-year Disease-free Survival|Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.|2 years|All registered participants who have met the eligibility criteria.|||percentage of participants|||Number
2767543|NCT00757172|Secondary|Percentage of Participants With 3-year Overall Survival|Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).|3 years|All registered participants who have met the eligibility criteria.|||percentage of participants|||Number
2767544|NCT00757172|Secondary|Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)||Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.|||participants|||Number
2774155|NCT00711009|Secondary|Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
2767545|NCT00757172|Primary|Number of Participants With Pathologic Complete Response Following Surgery|Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.|Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.|||participants|||Number
2767546|NCT00757003|Secondary|Overall Survival|Overall survival is reported as the count of participants alive 60 months following implant procedure.|60 months|9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded|||Participants|||Count of Participants
2767547|NCT00757003|Secondary|Count of Participants Experiencing at Least One Endoleak Following Procedure|Endoleak is persistent blood flow in the aneurysm sac.|Up to 60 months following procedure||||Participants|||Count of Participants
2767548|NCT00757003|Primary|Percentage of Participants With Technically Successful Implant|The percentage of participants with technically successful implantation as assessed by the investigator is reported.|Day 0 to Day 30||||percentage of participants|||Number
2767549|NCT00756977|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days||||mOsm/kg||Standard Deviation|Mean
2767550|NCT00756977|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days||||MILL/MCL||Standard Deviation|Mean
2767551|NCT00756977|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
2767552|NCT00756977|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|Intent to treat population|||1000/MCL||Standard Deviation|Mean
2767553|NCT00756977|Secondary|Serum Chemistry Results (GFR)|Change from Baseline|2 days||||ml/min||Standard Deviation|Mean
2767554|NCT00756977|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||g/dL||Standard Deviation|Mean
2767555|NCT00756977|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||mEq/L||Standard Deviation|Mean
2767556|NCT00756977|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||U/L||Standard Deviation|Mean
2767557|NCT00756977|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population|||standard %||Standard Deviation|Mean
2767558|NCT00756977|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||mg/dL||Standard Deviation|Mean
2767559|NCT00756977|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent"|2-day||||percentage of participants||95% Confidence Interval|Number
2767560|NCT00756964|Primary|Number of Patients With Acute Kidney Injury (AKI).|Acute kidney injury will be defined as an increase in serum creatinine of 0.3mg/dL from baseline or a 50% increase in serum creatinine from baseline values within 48 hours after surgery.|Within 48 hours postoperatively|As no similar study has been performed, a power analysis could not be performed. As such, we decided to do a pilot study with 26 subjects and to set criteria to maximize the likelihood of seeing an effect.|||Participants|||Number
2767561|NCT00756938|Primary|Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.|||Participants|||Number
2767562|NCT00756938|Primary|Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.|||Participants|||Number
2767563|NCT00756938|Secondary|Mean Change From Baseline in Diastolic Blood Pressure|Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation|||mmHg||Standard Deviation|Mean
2767564|NCT00756938|Primary|Mean Change From Baseline in Systolic Blood Pressure|Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation|||mmHg||Standard Deviation|Mean
2767565|NCT00756886|Primary|Atrial Fibrillation||0-21 days post-operative||||participants|||Number
2767566|NCT00756730|Primary|The Change in Fasting Triglyceride Level From Baseline to Week 24||Baseline to week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
2767567|NCT00756730|Primary|At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||percentage of participants|||Number
2767568|NCT00756730|Secondary|HDL Cholesterol at Week 24||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
2767569|NCT00756730|Secondary|LDL Cholesterol at Week 24||week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
2767573|NCT00756730|Primary|Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.|A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.|baseline, 24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.|||percentage of patients|||Number
2767574|NCT00756717|Primary|Number of Participants Experiencing at Least One Adverse Event|The number of participants experiencing at least one adverse event during the 24-day observation period and initial post-operative visit.|30 days||||Participants|||Count of Participants
2767575|NCT00756678|Secondary|Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16|Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.|Day 16|Intent to Treat; defined as all randomized (started study) patients.|||Number of patients|||Number
2767576|NCT00756678|Secondary|Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16|"Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree."|Day 16|Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure|||Percentage of Patients|||Number
2767577|NCT00756678|Secondary|Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16|Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.|Baseline, Day 16|Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2767578|NCT00756678|Primary|Mean Frequency of Eye Drop Use Over 1 Week|Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.|1 week|Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure|||Use per day||Standard Deviation|Mean
2767579|NCT00756613|Secondary|Patients Reported Health Related Quality of Life|Self-reported health status using an instrument adapted for type 2 diabetes mellitus patients from the Diabetes Control and Complications Trial (DCCT) (Duckworth, 1998; Saudek 1996). This survey tool has been used since the inception of the VADT and will be continued in the annual survey. The minimum value is 0 and the maximum value is 100. The higher score is a better outcome.|9 years|T-test for comparing between the two treatment groups using the average of last two responses of the surveys.|||score on a scale||Standard Deviation|Mean
2767580|NCT00756613|Secondary|Number of Events on Major Microvascular or Macrovascular Outcome|End-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal MI, stroke, or new CHF.|15 years|Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study.|||events|||Number
2767581|NCT00756613|Secondary|The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality.|The major secondary end-point of total mortality will measure all deaths with data retrieved from VA Information Resource Center (VIREC) Cooperate Data Warehouse (CDW) . Survival analysis will analyzed by time to death.|15 years|Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study.|||Participants|||Count of Participants
2767582|NCT00756613|Secondary|The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality.|The major secondary end-point of cardiovascular (CV) mortality will measure the cause of death (end-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal myocardial infarction (MI), stroke, or new congestive heart failure (CHF)) retrieved by the National Death Index (NDI). Survival analysis will analyzed by time of event to death.|15 years|Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study.|||Participants|||Count of Participants
2767583|NCT00756613|Primary|The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication.|Major CV events (non-fatal MI resulting in hospitalization, non-fatal stroke, new Congestive Heart Failure (CHF), amputation for ischemic diabetic gangrene, or CV-related death).|15 years|Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study.|||number of events|||Number
2767584|NCT00756600|Secondary|Awareness of Group Allocation by Pediatrician||At 5 years chronological age||||Pediatricians|||Number
2767585|NCT00756600|Secondary|Awareness of Group Allocation by Psychologist|These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age||||psychologists|||Number
2774156|NCT00711009|Secondary|Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
2767586|NCT00756600|Secondary|Parents' Awareness of Group Allocation|Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age||||caregivers|||Number
2767587|NCT00756600|Secondary|Number of Participants Who Have Cerebral Palsy|Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767588|NCT00756600|Secondary|Number of Participants Who Are Legally Blind|Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767589|NCT00756600|Secondary|Number of Participants With a Hearing Aid|Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767590|NCT00756600|Secondary|Number of Participants With a Visual Defect in Either Eye|Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767591|NCT00756600|Secondary|Number of Participants With a Hearing Abnormality|Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767592|NCT00756600|Secondary|Number of Participants With Autism Spectrum Disorder|Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767593|NCT00756600|Secondary|Number of Participants With Attention Deficit Hyperactivity Disorder|Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767594|NCT00756600|Secondary|Number of Participants With Global Developmental Delay|Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767595|NCT00756600|Secondary|Psychomotor Interventions|Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767596|NCT00756600|Secondary|Speech or Language Interventions|Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||participants|||Number
2767597|NCT00756600|Secondary|Externalising Problems T Score|"Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score~Minimum possible score: 40 Maximum possible score: 100~A higher score indicates a worse outcome.~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767598|NCT00756600|Secondary|Internalising Problems T Score|"Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score~Minimum possible score: 40 Maximum possible score: 100~A higher score indicates a worse outcome.~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767599|NCT00756600|Secondary|Total Problems Score|"Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems~Minimum possible score: 40 Maximum possible score: 100~A higher score indicates a worse outcome.~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767600|NCT00756600|Secondary|The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System|"Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System~- 2nd edition (ABAS-II) to measure the child's adaptive behavior.~Minimum possible score: 45 Maximum possible score: 145~A higher score indicates a better outcome.~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767601|NCT00756600|Secondary|The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function|"Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function~Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities.~Minimum possible score: 40 Maximum possible score: 110~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.~A higher score indicates a worse outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767602|NCT00756600|Secondary|Memory and Learning Word Lists II (Delayed) Scaled Score|"Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767603|NCT00756600|Secondary|Word Lists 1 (Learning) Scaled Score|"Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767604|NCT00756600|Secondary|Numbers Total Scaled Score|"Children's Memory Scale (CMS):Numbers Total scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767605|NCT00756600|Secondary|Spelling Standard Score|"Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score~Minimum possible score: 45 Maximum possible score: 145~A higher score indicates a better outcome.~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767606|NCT00756600|Secondary|Numerical Operations Standard Score|"Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score~Minimum possible score: 45 Maximum possible score: 145~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.~A higher score indicates a better outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767607|NCT00756600|Secondary|Word Reading Standard Score|"Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score~Minimum possible score: 45 Maximum possible score: 145~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.~A higher score indicates a better outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767608|NCT00756600|Secondary|Design Copy Process Total Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on a scale||Standard Deviation|Mean
2767609|NCT00756600|Secondary|Fingertip Tapping Sequences Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age||||score on scale||Standard Deviation|Mean
2767610|NCT00756600|Secondary|Fingertip Tapping Repetitions Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score is indicative of a better outcome."|At 5 years corrected age||||score on scale||Standard Deviation|Mean
2767611|NCT00756600|Secondary|Speeded Naming Combined Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767612|NCT00756600|Secondary|Theory of Mind Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767613|NCT00756600|Secondary|Memory for Names and Memory for Names Delay|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767614|NCT00756600|Secondary|Affect Recognition Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767904|NCT00754494|Secondary|Normal Mucosa OSI-420 Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mg||Standard Deviation|Mean
2767615|NCT00756600|Secondary|Word Generation Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767616|NCT00756600|Secondary|Inhibition Combined Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767617|NCT00756600|Secondary|Statue Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767618|NCT00756600|Secondary|Auditory Attention Combined Scaled Score|"Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767619|NCT00756600|Secondary|Sentence Repetition Scaled Score|"Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score~Minimum possible score: 1 Maximum possible score: 19~A higher score indicates a better outcome."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767620|NCT00756600|Secondary|Processing Speed Quotient|"Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient~Minimum possible score:45 Maximum possible score:145~A higher score indicates a better outcome.~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767621|NCT00756600|Secondary|Performance IQ|"Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ~Minimum possible score:45 Maximum possible score:145~A higher score indicates a higher performance IQ (better outcome).~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years corrected age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767622|NCT00756600|Secondary|Verbal IQ|"Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ~Minimum possible score:45 Maximum possible score:145~A higher score indicates higher verbal IQ (better outcome).~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years corrected age.|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767623|NCT00756600|Primary|Full Scale IQ Score|"The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability.~Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome).~Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment."|At 5 years chronological age|Not all participants had data collected for this Outcome Measure due to absence at follow up visit.|||score on scale||Standard Deviation|Mean
2767624|NCT00756574|Secondary|Absenteeism|Absent from work because of flu-like illness|over study period||||participants|||Number
2767625|NCT00756574|Secondary|Influenza-like Illness|Cough and fever|Over entire study period||||participants|||Number
2767626|NCT00756574|Secondary|Physician Visits for Respiratory Illness|visit to primary care MD|one year||||participants|||Number
2767627|NCT00756574|Primary|Laboratory-confirmed Influenza Infection|Laboratory confirmed influenza|one year||||participants|||Number
2767628|NCT00756561|Primary|Intratesticular Hormones in Normal Men|Average between right and left testis for each subject and serum hormone concentration in 10 normal men|6-weeks|per protocol|||ng/mL||Inter-Quartile Range|Median
2767629|NCT00756548|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days||||mOsm/kg||Standard Deviation|Mean
2767630|NCT00756548|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days||||million/microliter||Standard Deviation|Mean
2767631|NCT00756548|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days||||1000/MCL||Standard Deviation|Mean
2767632|NCT00756548|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
2767633|NCT00756548|Secondary|Serum Chemistry Results - Glomerular Filtration Rate|Change from Baseline|2 days||||ml/min||Standard Deviation|Mean
2767634|NCT00756548|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
2767635|NCT00756548|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days||||mg/dL||Standard Deviation|Mean
2767636|NCT00756548|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days||||U/L||Standard Deviation|Mean
2767637|NCT00756548|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population|||Percentage of cells||Standard Deviation|Mean
2767638|NCT00756548|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days||||milliequivalent/L||Standard Deviation|Mean
2767639|NCT00756548|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent)"|2 days|186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
2767640|NCT00756470|Primary|Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy|Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.|Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)|With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.|||Percentage of Participants|||Number
2767641|NCT00756470|Secondary|Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)|Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.|Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)|While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.|||participants|||Number
2767642|NCT00756457|Secondary|Foot Strength|A force transducer (Model SML-200, Interface, Scottsdale, AZ) was connected in series with a resistance plate and oscilloscope (TDS 410A, Tektronix, Beaverton, OR) to display force readings. Participants were seated with their leg in an an air stirrup brace (Aircast, Inc.) mounted on uprights. The air stirrup brace was adjusted so the heel was approximately 10 cm above the resistance plate, resulting in 30 to 45 degrees of ankle plantar flexion depending on foot length. The resistance plate was mounted on ball bearing tracks in the medial/lateral direction and moleskin was used to fit to the general shape of the medial forefoot. The result was that participants could exert maximum effort against the resistance plate (medial direction) with little discomfort. This testing position essentially replicates the manual muscle test position for the posterior tibialis muscle. Force in Newtons was then divided by body mass in kilograms to calculate normalized strength (N/Kg).|Measured at Weeks 1, 6, and 12||||N/kg||Standard Deviation|Mean
2767643|NCT00756457|Primary|Short Musculoskeletal Functional Assessment|The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients' perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.|Measured at Weeks 1, 6, and 12||||score||Standard Deviation|Mean
2767644|NCT00756457|Secondary|Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)|A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate systems were established for each segment using digitized boney landmarks consistent with a previous study. Kinematic data were smoothed using a 4th order, zero phase lag, Butterworth filter with a cut off frequency of 6 Hz. To calculate relative joint angles a Cardan angle Z-X-Y sequence of rotations was used as suggested by Cole et al. The range of possible values varies for each individual and each joint.|Measured at Weeks 1,6 and 12||||Degrees||Standard Deviation|Mean
2767645|NCT00756457|Primary|Foot Function Index(FFI)|The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.|Measured at Weeks 1, 6, and 12|A power analysis was performed based on previous a previous study. Only the participants that completed the study are included in the analysis. One participant opted to have surgery at 2 weeks from the Brace & Exercise group. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.|||units on a scale||Standard Deviation|Mean
2767690|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767646|NCT00756444|Primary|Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab|Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab|24 to 96 hours following start of cycle 2 infusion with 5-FU|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive Css|||ng/mL||Standard Deviation|Mean
2767647|NCT00756444|Primary|Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab|AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.|Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive AUC|||ng*hr/mL||Standard Deviation|Mean
2767648|NCT00756314|Secondary|Satisfaction With the Used Contraceptive Method|the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.|During the 6-month Follow-up||||participants|||Number
2767649|NCT00756314|Primary|Chosen Contraceptive Method After Counseling|the type of contraceptive methods chosen by women following after counseling|after the contraceptive counseling||||participants|||Number
2767650|NCT00756314|Secondary|Pregnancies Among All Women||within the first six months after intervention||||participants|||Number
2767651|NCT00756314|Primary|Correct Use of the Method|the correct use was considerer by each methods according the prescription.|within the first 6 months after intervention||||participants|||Number
2767652|NCT00756314|Primary|Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up|"The acceptability and the use of contraceptives during the follow-up period was defined as just yes or no"|after the contraceptive counseling and during the 6-month follow|"The analysis was by intention to treat in both groups. All the women were retained in their original assigned group."|||participants|Participants||Number
2767653|NCT00756275|Secondary|Beck Depression Inventory|0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression|Week 12|Outcome data available for 80 participants who had valid depression data 12 week assessment.|||units on a scale||Standard Deviation|Mean
2767654|NCT00756275|Secondary|Percent Relapsed to Any Heavy Drinking|6 or more drinks for men; 5 or more drinks for women|6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of particpiants|||Number
2767655|NCT00756275|Secondary|Percent Relapsed to Any Heavy Drinking|6 or more drinks for men; 5 or more drinks for women|3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of participants|||Number
2767656|NCT00756275|Secondary|Percent Relapsed to Drug Use||6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of participants|||Number
2767657|NCT00756275|Secondary|Percent Relapsed to Drug Use||3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of participants|||Number
2767658|NCT00756275|Secondary|Percent Smoking Days||6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of days||Standard Deviation|Mean
2767659|NCT00756275|Secondary|Percent Smoking Days||3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of days||Standard Deviation|Mean
2767660|NCT00756275|Primary|7-day Point-prevalence Smoking Abstinence|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|6 month follow up||||participants|||Number
2767661|NCT00756275|Secondary|Length of Longest Continuous Abstinence||Weeks 9 to 12||||Days||Standard Deviation|Mean
2767662|NCT00756275|Primary|7-day Point-prevalence Smoking Abstinence|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|3 month follow up|"Intent to Treat Note: People who were lost were counted as smoked"|||participants|||Number
2767663|NCT00756236|Primary|Area Under the Curve of etSEV Over the First Hour|We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.|Every 5 minutes for 2 hours||||percent*hour||Standard Deviation|Mean
2767664|NCT00756106|Primary|Affects of a Short Period of 100% Oxygen Inhalation on Imaging of Tumor and Surrounding Tissue Regions of Interest, Specifically Cerebral Blood Volume Changes in Each Area as Compared to Room Air||Baseline, weekly during treatment, monthly following treatment for up to six months|Data not collected||||||
2767665|NCT00756106|Primary|Relative Regional Concentrations of Choline, N-acetyl-asparate, and Myoinositol as Measured by Magnetic Resonance Spectroscopy Before, During, and After Chemoradiotherapy to Interrogate Cell Membrane Turnover, Neuronal Integrity, and Glial Reactions||Baseline, weekly during treatment, monthly following treatment for up to six months|Data not collected||||||
2767666|NCT00756106|Primary|Tensor Fractional Anisotropy Before, During, and After Chemoradiotherapy|Fractional anisotropy (FA) is a measure of the directionality of the molecular motion of water.|Baseline, weekly during treatment, monthly following treatment for up to six months|Data not collected||||||
2767667|NCT00756106|Primary|Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy|"Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue. ADC was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point.~CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide"|Baseline, weekly during treatment, monthly following treatment for up to six months|The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study|||mm2/s||Full Range|Mean
2767668|NCT00756106|Primary|Permeability-surface Area Product Before, During, and After Chemoradiotherapy|"Permeability-surface Area Product (Ktrans). Ktrans reflects the efflux rate of contrast from blood plasma into the tissue extravascular extracellular space (EES). Ktrans was assessed using post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point.~CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide"|Baseline, weekly during treatment, monthly following treatment for up to six months|The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study|||min ^-1||Full Range|Mean
2767669|NCT00756106|Primary|Mean Transit Time as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy|Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.|Baseline, weekly during treatment, monthly following treatment for up to six months|Data not collected||||||
2767670|NCT00756106|Primary|Vessel Diameter as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy||Baseline, weekly during treatment, monthly following treatment for up to six months|Data not collected||||||
2767671|NCT00756106|Primary|Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy|"Relative cerebral blood flow (rCBF) is the blood flow rate (the volume of blood passing through the specified are over a specified period of time) in the region of interest (ROI) divided by the blood flow rate in the symmetrical region on the other side of the normal brain (control region). CBF was assessed using spin-echo post-contrast T1-weighted images. CBF was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation.~CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide"|Baseline, weekly during treatment, monthly following treatment for up to six months|The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study|||ratio||Full Range|Mean
2767672|NCT00756106|Primary|Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy|"Relative cerebral blood volume (rCBV) is the blood volume in the region of interest (ROI) divided by the blood volume in the symmetrical region on the other side of the normal brain (control region). CBV was assessed using spin-echo post-contrast T1-weighted images. Multiple images were used to assess each participant at every time-point and the median value for each participant was calculated by time-point. The data presented represent the average of those median values at each time-point. The baseline value was measured twice (representing baseline 1 and 2) to make sure that the value was reproducible and to account for any variation attributable to measurement variation.~CRT: Chemoradiotherapy Cx: The cycle number TMZ: temozolomide"|Baseline, weekly during treatment, monthly following treatment for up to six months|The number of patients evaluated decreased over time due to participants experiencing disease progression and discontinuing from the study|||ratio||Full Range|Mean
2767673|NCT00756093|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.|once upon instillation||||units on a scale||Standard Deviation|Mean
2767674|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5).|"The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767675|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4).|"The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767676|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2).|"The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767677|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
2767678|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
2767679|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
2767680|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
2767681|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
2767682|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
2767683|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5).|"The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767684|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4).|"The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767685|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2).|"The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767686|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767687|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767688|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767689|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767726|NCT00755911|Secondary|Number of Participants Who Successfully Received Dental Implant Fixtures|The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures|12 months after tooth extraction||||participants|||Number
2767691|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767692|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5).|"The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent."|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767693|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4).|"The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent."|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767694|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2).|"The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent."|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767695|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30).|Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767696|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767697|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
2767698|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 29-30).|The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
2767699|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 15-16).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
2767700|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 1-2).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
2767701|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5).|"Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767905|NCT00754494|Secondary|Normal Mucosa Erlotinib Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mg||Standard Deviation|Mean
2767702|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4).|"Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767703|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2).|"Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767704|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 29 -30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767705|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767706|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767707|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 29-30).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767708|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 15-16).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767709|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 1-2).|All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767710|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5).|"Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767711|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4).|"Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767712|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2).|"Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural home setting."|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767713|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767714|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767715|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767716|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767717|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
2767718|NCT00756002|Primary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.|Nights 1-2|The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data.|||minutes||Standard Error|Least Squares Mean
2767719|NCT00755937|Secondary|Number of Serious Adverse Events||Throughout study (up to 36 months)|Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105.|||Number of Serious Adverse Events|||Number
2767720|NCT00755937|Primary|Clinical Remission at 36 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
2767721|NCT00755937|Primary|Clinical Remission at 24 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
2767722|NCT00755937|Primary|Clinical Remission at 12 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
2767723|NCT00755937|Primary|Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
2767724|NCT00755937|Primary|Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
2767725|NCT00755937|Primary|Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
2774157|NCT00711009|Secondary|Mean Change From Baseline in Basophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2767727|NCT00755911|Primary|Bone Regeneration|"The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.~Safety was assessed through adverse event reporting~Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)"|12 months after tooth extraction||||% bone height||Standard Deviation|Mean
2767728|NCT00755846|Secondary|Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).|The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.|85 Days.|"Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.~Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics."|||percent incidence||Standard Deviation|Mean
2767729|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 85).|The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767730|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 43).|The change between triglycerides collected at day 43 and triglycerides collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767731|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).|The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767732|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).|The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767733|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).|The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767734|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).|The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767735|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 85).|The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767736|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 43).|The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767737|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 85).|The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767738|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 43).|The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767739|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 85).|The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767740|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 43).|The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2767741|NCT00755846|Secondary|Change From Baseline in Glycosylated Hemoglobin at Day 43.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2767742|NCT00755846|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2767743|NCT00755807|Secondary|Change From Baseline in Weight at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||kilograms (kg)||Standard Deviation|Mean
2767744|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||beats per minute (bpm)||Standard Deviation|Mean
2767745|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||mm Hg||Standard Deviation|Mean
2767746|NCT00755807|Other Pre-specified|Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||gram/deciliter (g/dL)||Standard Deviation|Mean
2767747|NCT00755807|Other Pre-specified|Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||milliEq/Liter||Standard Deviation|Mean
2767748|NCT00755807|Other Pre-specified|Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||Thousand/microliter||Standard Deviation|Mean
2767749|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase||Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.|||participants|||Number
2767750|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.|||participants|||Number
2767751|NCT00755807|Secondary|Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)||Baseline (6 weeks) through Endpoint (18 weeks)|All participants randomized to placebo in acute phase received duloxetine during the extension phase.|||participants|||Number
2767752|NCT00755807|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
2767753|NCT00755807|Secondary|Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.|Baseline (6 weeks) through Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Error|Least Squares Mean
2767754|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|18 weeks|All randomized participants who entered the extension phase.|||participants|||Number
2767755|NCT00755807|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
2767906|NCT00754494|Secondary|Plasma OSI-420 Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mL||Standard Deviation|Mean
2767756|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
2767757|NCT00755807|Secondary|Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline (end of acute phase/Week 6), Endpoint (Week 18)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
2767758|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).|18 weeks|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
2767759|NCT00755807|Secondary|Change From Baseline in Weight at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||kilograms (kg)||Standard Error|Least Squares Mean
2767760|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2767761|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mm Hg||Standard Error|Least Squares Mean
2767762|NCT00755807|Other Pre-specified|Change From Baseline in Uric Acid at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of uric acid.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mg/dL||Standard Deviation|Mean
2767763|NCT00755807|Other Pre-specified|Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mg/dL||Standard Deviation|Mean
2767764|NCT00755807|Other Pre-specified|Change From Baseline in the Platelet Count at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of platelet count.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||Thousand/microliter||Standard Deviation|Mean
2767765|NCT00755807|Other Pre-specified|Change From Baseline in Creatinine at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of creatinine.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2767766|NCT00755807|Other Pre-specified|Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||milliEq/Liter||Standard Deviation|Mean
2767767|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase||Baseline through 6 weeks|All randomized participants.|||participants|||Number
2767768|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline through 6 weeks|All randomized participants.|||participants|||Number
2767769|NCT00755807|Secondary|Number of Participants Who Discontinued During the Acute Phase (by Week 6)||Baseline through 6 weeks|All randomized participants.|||participants|||Number
2767770|NCT00755807|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Deviation|Mean
2767771|NCT00755807|Secondary|Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2767772|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|6 weeks|All randomized participants.|||participants|||Number
2767907|NCT00754494|Secondary|Plasma Erlotinib Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mL||Standard Deviation|Mean
2767773|NCT00755807|Secondary|Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2767774|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2767775|NCT00755807|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2767776|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|6 weeks|Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.|||units on a scale||Standard Error|Least Squares Mean
2767777|NCT00755807|Secondary|Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.|||participants|||Number
2767778|NCT00755807|Primary|Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2767779|NCT00755755|Primary|Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)|Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.|Week 13|Intent-to-treat|||percentage of change||Full Range|Median
2767780|NCT00755755|Primary|Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|Week 13 visit|Intent-to-treat|||percentage of patients|||Number
2767781|NCT00755716|Secondary|MNWS|"Minnesota Nicotine Withdrawing Scale~Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms."|Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.|Subjects only needed to have an MNWS at one of these time points (weeks 7-10) to be included in the analysis.|||units on a scale||Standard Error|Mean
2767782|NCT00755716|Primary|Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.|The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.|weeks 7-10||||Participants|||Count of Participants
2767796|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Titers||95% Confidence Interval|Geometric Mean
2767783|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 12 weeks||||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
2767784|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 4 weeks||||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
2767785|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|Form baseline to 12 weeks||||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
2767786|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|From baseline to 4 weeks||||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
2767787|NCT00755326|Secondary|Patient Global Assessment|"§Patient Global Assessment is on a scale of 1-5, with 5 indicating excellent and 1 indicating poor (in response to the question Considering all the ways that your osteoarthritis of the knee affects you, how are you feeling today?)"|8 weeks|Same as baseline|||Units on a scale||Standard Deviation|Mean
2767788|NCT00755326|Secondary|Function Normalized Score|Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis. Overall normalized score is on a scale of 0-30, and is the sum of the pain, stiffness and function normalized scores (each on a scale of 0-10).|8-Weeks|Same as baseline.|||Units on a scale||Standard Deviation|Mean
2767789|NCT00755326|Primary|‡Pain Normalized Score|‡Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis.|8 weeks|Same as baseline.|||Units on a scale||Standard Deviation|Mean
2767790|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
2767791|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.|Day 28 post-single dose or Day 21 post-Dose 2|"Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
2767792|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
2767793|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 2|Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)|||Participants|||Number
2767794|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
2767795|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data."|||Titers||95% Confidence Interval|Geometric Mean
2767797|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.|||Participants|||Number
2767798|NCT00755261|Primary|RECIST|Study was terminated because of low accrual.|6 month PFS|study was terminated because of low accrual (4 subjects enrolled/2 years)||||||
2767799|NCT00755235|Secondary|Treatment Satisfaction|"Single item seven point scale ranging from very satisfied to very dissatisfied"|Measured after 6 months of treatment||||participants|||Number
2767800|NCT00755235|Primary|20-Item Symptom Checklist Depression Scale|20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.|Measured at baseline and after 6 months of treatment|Analysis included all participants participating in outcome assessment|||units on a scale||Standard Deviation|Mean
2767801|NCT00755222|Primary|Change From Baseline in PDQ Penile Pain|Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
2767802|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Discomfort|"Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
2767803|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Contraint|"Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
2767804|NCT00755222|Primary|Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother|"Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
2767805|NCT00755222|Primary|Change From Baseline in Penile Curvature|Negative change reflects improvement in penile curvature|Baseline and Week 36 or last observation carried forward (LOCF)||||Percent change from baseline||Standard Deviation|Mean
2767806|NCT00755196|Secondary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.|Day 7, 14, 28, 42, 56, 70, 91|ITT population included all randomized participants who received the study medication.|||percentage of participants|||Number
2767807|NCT00755196|Primary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.|Day 84|ITT population included all randomized participants who received the study medication.|||percentage of participants|||Number
2767808|NCT00755131|Other Pre-specified|Heart Rate Recovery at Baseline and 6 Months|"The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system.~Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease."|baseline and 6 month follow-up||||beats/min||Standard Deviation|Mean
2767809|NCT00755131|Secondary|Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months|Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.|Baseline and 6-month follow-up|intention to treat (ITT) analysis|||ml/kg/min||Standard Deviation|Mean
2767810|NCT00755131|Primary|High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months|High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.|baseline and 6-month follow-up||||ng/ml||Standard Deviation|Mean
2767811|NCT00755105|Primary|Rate of Iron Excretion.|Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55|4 years|Per protocol|||milligrams per day||95% Confidence Interval|Mean
2767812|NCT00755079|Secondary|Expiratory Respiratory Muscle Strength|Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.||||cmH2O||Standard Deviation|Mean
2774158|NCT00711009|Secondary|Mean Change From Baseline in Eosinophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2767814|NCT00755040|Secondary|Numerical Score of Ocular Surface Disease Index (OSDI) and Development or Lack of Ocular GVHD (by Ophthalmologic Examination) as Measured by Odds Ratio in a Linear Regression Model.|OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.|1 year after transplant|Not collected/analysed due to staffing constraints||||||
2767815|NCT00755040|Primary|Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)|Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.|Up to 2 years after transplantation|Number of patients that develop ocular GVHD while on study|||participants|||Number
2767816|NCT00754936|Secondary|Hamilton Depression Rating Scale (Depression Severity)|A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|14 weeks from enrollment (12 weeks from medication start)||||units on a scale||Standard Deviation|Mean
2767817|NCT00754936|Primary|Montgomery Asberg Depression Rating Scale (Depression Severity)|A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|14 weeks from enrollment (12 weeks from medication start)||||units on a scale||Standard Deviation|Mean
2767818|NCT00754923|Secondary|Mutational Status for EGFR or Kras||up to 2 years||||participants|||Number
2767819|NCT00754923|Secondary|Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE)|Assess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.|Up to 2 years||||percentage of participants|||Number
2767820|NCT00754923|Secondary|Overall Survival Rate|Determine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC|Up to 2 years||||months||95% Confidence Interval|Median
2767821|NCT00754923|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate"|6 months||||participants|||Number
2767822|NCT00754845|Secondary|Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey|Difference between post baseline scores and baseline score of role function-physical scale on SF-36 Health Survey (scale range between 0 and 100 with higher score indicating better quality of life).|8 years|All randomized patients.|||score on a scale||Standard Error|Least Squares Mean
2767823|NCT00754845|Secondary|Overall Survival (OS)|For subjects who died, overall survival was calculated in months from the day of randomization to the date of death. Otherwise, survival was censored at the last day the patient was known to be alive. Probability of overall survival at 5 years is estimated and reported.|Until the end of study with a median follow-up of 75 months|All women randomized|||probability of OS at 5 years||95% Confidence Interval|Number
2767824|NCT00754845|Secondary|Incidence of Contralateral Breast Cancer|The annual incidence rate was estimated based on the time to the development of contralateral breast cancer, which was calculated in months from the day of randomization to the diagnosis date of contralateral breast cancer for subjects who had developed the contralateral breast cancer, to the time of death for the patient who died, or to the last day the patient was known alive for subjects without contralateral breast cancer|10 years|All women randomized|||Number of new case per 1000 person years||95% Confidence Interval|Number
2767825|NCT00754845|Primary|Disease-free Survival (DFS)|It is defined as the months from the day of randomization to the earliest date when a recurrence of the primary disease (recurrence in the breast, chest wall and nodal sites or the development of metastatic disease) or a contralateral breast cancer was observed. Subjects who died without recurrence of the primary disease or the development of the contralateral breast cancer were censored at their death date. If a patient has not recurred, developed a contralateral breast cancer, or died, disease-free survival was censored on the date of the last day the patient was known to be alive. Probability of disease free survival at 5 years is estimated and reported.|Unitil the end of study with a median follow up of 75 months|All women randomized were included in the analysis based on treatment arm they were randomized.|||probability of DFS at 5 years||95% Confidence Interval|Number
2767826|NCT00754832|Secondary|Realtime Digital Fatigue Score|fatigue scored on 0-10 scale with higher scores indicating more fatigue|6 weeks of intervention||||units on a scale||Standard Deviation|Mean
2767827|NCT00754832|Secondary|Modified Fatigue Impact Scale|21 item scale, score range 0-84, lower scores indicate less fatigue|6 weeks of intervention||||units on a scale||Standard Deviation|Mean
2767828|NCT00754832|Primary|Fatigue Severity Scale|The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.|after 6 weeks of intervention|intention to treat|||units on a scale||Standard Deviation|Mean
2767829|NCT00754793|Primary|Sino-Nasal Outcome Test-20 (SNOT-20)||baseline, 1 month, 3 months|||||||
2767830|NCT00754767|Primary|Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork|Data was not analyzed due to study termination|baseline, days 1 and 2 post chemo x 4 cycles|||||||
2767831|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 36 months post randomization||||participants|||Number
2768280|NCT00752726|Secondary|Change From Baseline to Week 24 in Liver Fat|The liver fat was measured by CT scan in Hounsfield Units (HU).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Hounsfield Units (HU)||Standard Deviation|Mean
2767832|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization||||Adherence - proportion||Standard Deviation|Mean
2767833|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization||||Adherence - proportion||Standard Deviation|Mean
2767834|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization||||Adherence - proportion||Standard Deviation|Mean
2767835|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization||||Adherence - proportion||Standard Deviation|Mean
2767836|NCT00754741|Secondary|LDL Cholesterol Levels||at 12 months post randomization||||mg/dL||Standard Deviation|Mean
2767837|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 12 months post randomization||||Percent||Standard Deviation|Mean
2767838|NCT00754741|Secondary|LDL Cholesterol Levels||at 6 months post randomization||||mg/dL||Standard Deviation|Mean
2767839|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 6 months post randomization||||Percent||Standard Deviation|Mean
2767840|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 24 months post randomization||||participants|||Number
2767841|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization||||Adherence - proportion||Standard Deviation|Mean
2767842|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization||||Adherence - proportion||Standard Deviation|Mean
2767843|NCT00754741|Primary|LDL-cholesterol Levels||at 18 months post randomization||||mg/dL||Standard Deviation|Mean
2767844|NCT00754741|Primary|Glycated Hemoglobin Levels||at 18 months post randomization||||Percent||Standard Deviation|Mean
2767845|NCT00754650|Secondary|Best Overall Response (BOR)|The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.|||Percentage of participants|||Number
2767846|NCT00754650|Primary|Bone Marrow Response|Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.|||Percentage of infiltration||Inter-Quartile Range|Median
2767847|NCT00754624|Secondary|High Resolution Computerized Tomography Scans of the Chest||End of study|participants in Safety population with available post-baseline data|||participants|||Number
2767848|NCT00754624|Secondary|Change in Weight in kg From Baseline to End of Study|Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months)|Safety|||kilograms||Standard Deviation|Mean
2767849|NCT00754624|Secondary|Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)|Change from Baseline to last study measurement on treatment (maximum of 48 months)|Baseline to last study measurement on treatment (maximum of 48 months)||||milligrams per deciliter||Standard Deviation|Mean
2767850|NCT00754624|Secondary|Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)|Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months|Safety|||percentage||Standard Deviation|Mean
2767855|NCT00754572|Secondary|Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
2767856|NCT00754572|Secondary|Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2767857|NCT00754572|Secondary|Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population. All participants with endpoint values collected at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
2767858|NCT00754572|Secondary|AUC of DAS28|The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||scores on a scale * years||Standard Deviation|Mean
2767859|NCT00754572|Secondary|Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24|DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2767860|NCT00754572|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24|DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
2767861|NCT00754572|Secondary|Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models|The probability of ACR positive response was determined using the GEE.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||odds||95% Confidence Interval|Number
2767862|NCT00754572|Secondary|Percentage of Participants Achieving ACR20 Response|"ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the HAQ-DI~Acute phase reactant levels - ESR or CRP"|Week 2|ITT Population; All participants with endpoint values collected at Week 2 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2767863|NCT00754572|Secondary|Area Under The Curve (AUC) of the ACR(n)|ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||percent*years||Standard Deviation|Mean
2767864|NCT00754572|Secondary|Percent Change From Baseline in HAQ-DI at Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
2767908|NCT00754494|Secondary|ACF: Normal Mucosa pERK Ratio|Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.|Up to day 30|ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels||||||
2767865|NCT00754572|Secondary|HAQ-DI at Baseline and Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified time point.|||units on a scale||Standard Deviation|Mean
2767866|NCT00754572|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
2767867|NCT00754572|Secondary|Physician's Global Assessment of Disease Activity at Baseline and Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
2767868|NCT00754572|Secondary|Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
2767869|NCT00754572|Secondary|Participant's Global Assessment of Disease Activity at Baseline and Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n= number of participants analyzed for the given parameter at the specified time point.|||mm||Standard Deviation|Mean
2767870|NCT00754572|Secondary|Percent Change From Baseline in Pain as Assessed by the Participant at Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at Baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
2767871|NCT00754572|Secondary|Pain as Assessed by the Participant at Baseline and Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at the specified timepoints were included in the analysis. number (n) equals (=) number of participants analyzed for the given parameter at the specified time point.|||mm||Standard Deviation|Mean
2767872|NCT00754572|Secondary|Percent Change From Baseline in SJC and TJC at Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
2767873|NCT00754572|Secondary|SJC and TJC at Baseline and Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||joints||Standard Deviation|Mean
2767874|NCT00754572|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
2767949|NCT00754156|Secondary|ICU Days||Duration of hospital stay less than 6 months||||Days||Inter-Quartile Range|Median
2767950|NCT00754156|Secondary|Days to Closure||Duration of Hospital Stay less than 6 months||||Days||Inter-Quartile Range|Median
2767875|NCT00754572|Secondary|Time to Onset of ACR20, ACR50, and ACR70|"ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
2767876|NCT00754572|Secondary|Percentage of Participants With ACR20 and ACR70 Response at Week 24|"ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2767877|NCT00754572|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments:~Participant's global assessment of pain by Visual Analog Scale (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)~Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2767878|NCT00754559|Secondary|Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response|Participants who withdrew from study drug due to other reasons were not taken into account.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; participants who withdrew from study drug due to other reaasons were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2767879|NCT00754559|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammation marker used to determine acute phase response.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.|||mm/h||Standard Deviation|Mean
2767880|NCT00754559|Secondary|Changes in C-Reactive Protein|CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.|Baseline, Weeks 1, 2 ,4 and 24|ITT Population|||mg/L||Standard Deviation|Mean
2767881|NCT00754559|Secondary|Changes in Hemoglobin|Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.|||g/dL||Standard Deviation|Mean
2767882|NCT00754559|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|"The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: effectiveness, side-effects, convenience and global satisfaction. All subscale scores range from 0 to 100%, with 100% being the best possible result."|Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
2767883|NCT00754559|Secondary|Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF|Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2 and 4|ITT Population; Missing data were imputed using LOCF.|||mm||Standard Deviation|Mean
2767884|NCT00754559|Secondary|Duration of Morning Stiffness as Assessed Using PTHF|Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline, Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.|||hours||Standard Deviation|Mean
2767885|NCT00754559|Secondary|Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)|Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.|||mm||Standard Deviation|Mean
2767886|NCT00754559|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2767887|NCT00754559|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2767951|NCT00754156|Primary|Operating Room Time Utilization|The amount of time needed to manage the open abdomen inside the operating room.|Duration of Hospital Stay less than 6 months||||Minutes||Standard Deviation|Mean
2767952|NCT00754156|Primary|Number of Trips to the Operating Room||12 Months||||Number of trips||Inter-Quartile Range|Median
2767953|NCT00754156|Primary|Primary Closure Rate|The rate in which the abdomen was closed the first time.|up to 12 months|Descriptive Study.|||% of participants|||Number
2767888|NCT00754559|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2767889|NCT00754559|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|"CDAI was calculated according to the following formula:~CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity."|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population; only participants with values for CDAI at baseline and the respective visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
2767890|NCT00754559|Secondary|Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24|"Participant's global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: no disease activity; right-hand extreme: maximum disease activity).~Physician's global assessment of disease activity was measured as participant's current disease activity on a 100-mm horizontal VAS scale (left hand extreme: no disease activity; right-hand extreme: maximum disease activity)."|Week 24|ITT Population; missing data were imputed using LOCF.|||mm||95% Confidence Interval|Mean
2767891|NCT00754559|Secondary|Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24|Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Week 24|ITT Population; missing data were imputed using LOCF.|||mm||95% Confidence Interval|Mean
2767892|NCT00754559|Secondary|Change From Baseline in the Levels of C-Reactive Protein at Week 24|The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.|Week 24|ITT Population; missing data were imputed using LOCF.|||mg/L||95% Confidence Interval|Mean
2767893|NCT00754559|Secondary|Change From Baseline in Swollen and Tender Joint Counts at Week 24|"Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.~Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68."|Week 24|ITT Population; missing data were imputed using last observation carried forward (LOCF).|||Joints||95% Confidence Interval|Mean
2767894|NCT00754559|Secondary|Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response|ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
2767895|NCT00754559|Secondary|Percentage of Participants With a DAS28 Response at Weeks 4 and 24|DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.|Weeks 4 and 24|ITT Population;|||percentage of participants||95% Confidence Interval|Number
2767896|NCT00754559|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population|||Percentage of Participants|||Number
2767897|NCT00754559|Secondary|Absolute Changes in DAS28 From Baseline|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; only participants with a DAS28 value at baseline were included in the analysis.|||units on a scale||Standard Deviation|Mean
2767898|NCT00754559|Primary|Percentage of Participants With Low Disease Activity Score at Week 24|Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Week 24|ITT population.|||Percentage of Participants||95% Confidence Interval|Number
2767899|NCT00754546|Secondary|Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise|"linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise~The higher the number the worse the shortness of breath"|After one dose||||breathlessness units/min||Standard Deviation|Least Squares Mean
2767900|NCT00754546|Primary|Exercise Endurance Time|Participants were asked to exercise until symptom limitation|After one dose|Number of participants determined by previous studies. Analysis was intention to treat|||seconds||Standard Deviation|Mean
2767901|NCT00754494|Secondary|Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks||||participants|||Number
2767909|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in ACF|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
2767910|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in ACF|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
2767911|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in Normal Mucosa|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
2767912|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in Normal Mucosa|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
2767913|NCT00754494|Primary|Change in ACF pERK Levels|Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.|From baseline to post-treatment (up to 30 days)|Change in ACF pERK levels not reported as the assay did not demonstrate signaling||||||
2767914|NCT00754468|Secondary|Side Effects of Subjects Receiving Cryospray Therapy.||End of Study||||side effects|||Number
2767915|NCT00754468|Primary|Depth of Injury|histopathological findings analyzed to determine max depth of injury (mm)|End of Study||||millimeters|Participants|80% Confidence Interval|Mean
2767916|NCT00754442|Secondary|The Number of Patients With Mutations in CYP27B1|CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data|blood samples taken at baseline and sequenced over several days|All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons|||participants|||Number
2767917|NCT00754442|Primary|The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours|1,25-D was measured at baseline, 4 and 8 hours after PTH infusion|baseline, 4 and 8 hours after start of infusion|The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis.|||pg/ml||Standard Deviation|Mean
2767918|NCT00754390|Primary|Zinc Absorption|Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time|16 weeks|Analysis restricted to women who completed all 4 treatment periods|||Percentage of Zinc-65 absorbed||Standard Error|Mean
2767919|NCT00754377|Secondary|Change in Knowledge Scores About Quality Improvement|Residents' knowledge was assessed using the knowledge scale (e.g., describe change concept, how a cause-effect diagram is created, elements of the improvement model) from the SQI TAT and scores could range from 0 to 54 points. Difference scores were used based on total score of the scale with larger positive values indicating more increase in knowledge.|1 Month||||units on a scale||Standard Deviation|Mean
2767920|NCT00754377|Primary|Beliefs About Ability to Implement a CQI Project|Residents' belief about their ability to implement a CQI project was measured using a single efficacy item (values ranged from 1, strongly disagree, to 5, strongly agree). The item is from the Systems Quality Improvement Training and Assessment Tool. Differences (post minus pre) in this belief item were looked at with positive and higher difference values reflecting more positive change/increase in belief.|1 month||||units on a scale||Standard Deviation|Mean
2767921|NCT00754338|Primary|Lens Deposits|Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
2767922|NCT00754338|Primary|Lens Wettability|Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
2767954|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr|Geometric Mean of the Day 5 to Day 1 Accumulation Ratio|Day 5 and Day 1|All participants with pharmacokinetic measurements on Days 1 and 5|||Ratio||Full Range|Geometric Mean
2774159|NCT00711009|Secondary|Mean Change From Baseline in Monocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2767923|NCT00754338|Secondary|Corneal Staining|"Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.~Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.~A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining."|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
2767924|NCT00754338|Secondary|Subjective Vision|Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
2767925|NCT00754338|Secondary|Dryness|Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.|4 weeks|analysis was per protocol|||Units on a Scale||Standard Deviation|Mean
2767926|NCT00754338|Primary|Comfort|Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
2767927|NCT00754325|Secondary|Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy.|||participants|||Number
2767928|NCT00754325|Secondary|Number of Participants With Best Overall Response|Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||participants|||Number
2767929|NCT00754325|Secondary|Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)|Table represents the best response achieved over this time frame. CR = Disappearance of all target lesions. No new lesions. PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||participants|||Number
2767930|NCT00754325|Secondary|Percentage of Participants With Clinical Benefit for At Least 6 Months|Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||percentage of participants||95% Confidence Interval|Number
2767931|NCT00754325|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan Meier assessments were used to estimate the percentages.|at 6 months|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||percentage of participants||95% Confidence Interval|Number
2767967|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767932|NCT00754325|Secondary|Median Time of Progression-free Survival (PFS)|Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||months||95% Confidence Interval|Median
2767933|NCT00754325|Primary|Number of Participants With Disease Progression (PD) or Death|This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant|||participants|||Number
2767934|NCT00754247|Secondary|Change in Lesion Cosmetic Appearance|Subjects assessed the scar cosmetic appearance with a visual analog scale (VAS), ranging from 0−100 (0=best and 100=worst).|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767935|NCT00754247|Secondary|Change in Lesion Cosmetic Appearance|Blinded investigator assessed the scar cosmetic appearance using a visual analog scale (VAS), ranging from 0−100 (0=best and 100=worst).|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767936|NCT00754247|Secondary|Change in Lesion Pigmentary Alteration|Blinded investigator assessed the scar pigmentation alteration using a visual analog scale (VAS), ranging from 0−100 (0=best and 100=worst).|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767937|NCT00754247|Secondary|Change in Lesion Erythema|Blinded investigator assessed the scar erythema. Measured with a visual analog scale (VAS), ranging from 0−100 (0=best and 100=worst).|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767938|NCT00754247|Secondary|Change in Lesion Induration|Blinded investigator assessed the scar induration. Measured with a ruler at deepest point.|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767939|NCT00754247|Secondary|Change in Lesion Width|Blinded investigator assessed the scar width. Measured with a ruler at the visually largest width.|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767940|NCT00754247|Secondary|Change in Lesion Length|Blinded investigator assessed the scar length. Measured with ruler, from scar tip to tip.|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent change||Standard Deviation|Mean
2767941|NCT00754247|Primary|Change in Lesion Volume|Blinded investigator assessed the scar volume by using an alginate impression.|Assessed at Baseline visit (week 0) and week 16|Data only available for participants that completed week 16 visit.|||Percent Change||Standard Deviation|Mean
2767942|NCT00754234|Primary|Nonheme Iron Absorption|Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL)|2 weeks (wks)|Analysis was per protocol|||percentage of nonheme Iron absorbed||Standard Deviation|Log Mean
2767943|NCT00754208|Secondary|Clinical Global Impression- Improvement|The Clinical Global Impression-Improvement scale is a measure of the clinician's assessment of the overall degree of improvement in ADHD symptoms from baseline to endpoint. The CGI-I is rated on a 1 to 6 scale, with 1=very much improved, 2=much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6=much worse.|8 weeks||||Participants|||Count of Participants
2767944|NCT00754208|Secondary|Change in Children's Global Assessment Scale (CGAS) Score|This measures the change in the subject's global assessment of functioning as rated by the clinician. This Children's Global Assessment Scale (CGAS) is rated on a 0-100 scale (refer to baseline information). The change in this score is the difference between the score at baseline to end point.|8 weeks||||units on a scale||Standard Deviation|Mean
2767945|NCT00754208|Secondary|Change in Clinical Global Impression-Severity|Change in global rating of severity of ADHD symptoms. CGI severity is rated on a scale of 1 to 6 (normal to severely ill; refer to description in baseline information). The change in the severity rating reflects the change in this score from baseline to endpoint.|8 weeks||||units on a scale||Standard Deviation|Mean
2767946|NCT00754208|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.|Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline.|8 weeks||||units on a scale||Standard Deviation|Mean
2767947|NCT00754156|Secondary|Blood Transfused||Duration of Hospital Stay less than 6 months||||Units||Inter-Quartile Range|Median
2767948|NCT00754156|Secondary|Hospital Days||Duration of Hospital Stay less than 6 months||||Days||Inter-Quartile Range|Median
2767955|NCT00754130|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.|||participants|||Number
2767956|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a t1/2 measurement|||hr||Standard Deviation|Mean
2767957|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a C24hr measurement|||nmol/L||Standard Deviation|Mean
2767958|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Tmax measurement|||hr||Full Range|Median
2767959|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Cmax measurement|||nmol/L||Standard Deviation|Mean
2767960|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with an AUC(0-24hr) measurement|||nmol*hr/L||Standard Deviation|Mean
2767961|NCT00754130|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.|||participants|||Number
2767962|NCT00754065|Other Pre-specified|The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
2767963|NCT00754065|Other Pre-specified|Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6|Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767964|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767965|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767966|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767990|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767968|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767969|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767970|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767971|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767972|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767973|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767974|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767975|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767976|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767977|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767978|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767979|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767980|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767981|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767982|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767983|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767984|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767985|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767986|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767987|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767988|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767989|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2767991|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767992|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767993|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767994|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767995|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2767996|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2767997|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2767998|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2767999|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768000|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768001|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768002|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768003|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768004|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768005|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768006|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768007|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768008|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768009|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768010|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768011|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768012|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 13|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768013|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768014|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768015|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768016|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2768017|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2768018|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2768019|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2768020|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768021|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768022|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768023|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768024|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768025|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768026|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768027|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
2768028|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768029|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768030|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2774160|NCT00711009|Secondary|Mean Change From Baseline in Lymphocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2768031|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768032|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768033|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768034|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768035|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768036|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768037|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768038|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768039|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768040|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768041|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768042|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768043|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768044|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768045|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768046|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768047|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768048|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768049|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768050|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768051|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768052|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768053|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768055|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768056|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768057|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768058|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768059|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768060|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768061|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768062|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768063|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
2768064|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768065|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768066|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768067|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768068|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
2768069|NCT00754065|Secondary|Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
2768070|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.|From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768105|NCT00753766|Secondary|Percentage of Participants Who Need to Return to the Operating Room||6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||percent of participants|||Number
2768071|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.|From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768072|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768073|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768074|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768075|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
2768076|NCT00754065|Secondary|The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.|From Baseline to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
2768077|NCT00754065|Secondary|The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.|From Baseline to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
2768078|NCT00754065|Primary|The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in Full Analysis Set (FAS) with assessment for this outcome measure|||mm||Standard Deviation|Mean
2768079|NCT00754052|Secondary|Mean Change From Baseline if the Forward Memory and Attention Sustained Sub-tests of the Leiter International Performance Scale - Revised (Leiter-R)|Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent was planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
2768080|NCT00754052|Secondary|Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER)|TOVER, a subject performance-based measure of expressive language function was planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
2768081|NCT00754052|Secondary|Mean Change From Baseline in Additional Analyses of the VABS-11/PCRF|Additional analyses of the VABS-II/PCRF were planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
2768082|NCT00754052|Primary|Mean Change From Baseline in Vineland-II Adaptive Behavior Scale (VABS-II) Parent/Caregiver Rating Form (PCRF) Score Using Last Observation Carried Forward (LOCF)|Mean change from Baseline from Visit 1 (baseline) to Visit 3 (Week 10 or early termination) in VABS-11/PCRF, a sum of the 9 sub-domain v-scores (3 scores for each of the communication, daily living skills, and socialization domains) using last observation carried forward was planned.|Baseline (Day 0) to Visit 3 (Week 10) or at early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
2768083|NCT00754013|Secondary|Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The planned secondary objectives of the study included further evaluation of efficacy as assessed by additional analyses of the VABS-II/PCRF, by analyses of the Test of Verbal Expression and Reasoning (TOVER), a subject-performance-based measure of expressive language function, and by the Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent. In addition, observed case analyses of these assessments at Week 4 and Week 10 were planned.|Visit 1 (Baseline) to Visit 3 (Week 10 or early termination).|This study was terminated early. Secondary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.||||||
2768084|NCT00754013|Primary|Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.|Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination).|The planned efficacy analysis was on the intent-to-treat (ITT) population. This study was terminated early. Primary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.||||||
2768085|NCT00753948|Secondary|Specific Airway Conductance (sGaw) as Measured by Plethysmography|Specific airway conductance (sGaw) is the airway conductance relative to lung volume because it takes into account the important effect of lung volume on airway resistance, it is a useful index of bronchomotor tone.|Specific airway conductance reported during visit, before intervention at baseline, post intervention at 60 minutes and 120 minutes||||L/sec/cmH20/L||Standard Deviation|Mean
2768086|NCT00753948|Primary|Exhaled Levels of Nitric Oxide|Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress. Exhaled NO was reported as the mean of three values within 10% of each other.|Exhaled NO reported during visit, before intervention at baseline, post intervention at 60 minutes and 120 minutes||||ppb (parts per bilion)||Standard Deviation|Mean
2768087|NCT00753935|Primary|Change in Serum Thromboxane B2|Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.|after 2 weeks on aspirin||||ng/mL||Inter-Quartile Range|Median
2768088|NCT00753922|Post-Hoc|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications|"The safety analyses were conducted in accordance with the FDA November 17, 2006 Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants. The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence > 5.0% are reported."|10 years|All Enrolled Subjects|||percentage of subjects||95% Confidence Interval|Number
2768089|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
2768090|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
2768164|NCT00753545|Secondary|Overall Survival (OS)|OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.|Follow up every 12 weeks post progression, assessed maximum up to 90 months.||||Months||95% Confidence Interval|Median
2768091|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
2768092|NCT00753922|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects|||centimeters||Standard Deviation|Mean
2768093|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included|||percentage of subjects||95% Confidence Interval|Number
2768094|NCT00753896|Secondary|Change in Blood Pressure From Baseline to Week 52|Change in Systolic and Diastolic Blood Pressure from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmHg||Standard Error|Mean
2768095|NCT00753896|Secondary|Change in Triglycerides From Baseline to Week 52|Change in Triglycerides from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
2768096|NCT00753896|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 52|Change in HDL from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
2768097|NCT00753896|Secondary|Change in Total Cholesterol From Baseline to Week 52|Change in Total Cholesterol from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
2768098|NCT00753896|Secondary|Change in Body Weight From Baseline to Week 52|Change in body weight from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Mean
2768099|NCT00753896|Secondary|Change in Fasting Serum Glucose From Baseline to Week 52|Change in fasting serum glucose from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
2768100|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 52|Percentage of patients achieving HbA1c <=6.5% at endpoint (for patients with HbA1c >6.5% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 6.5%. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
2768101|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 52|Percentage of patients achieving HbA1c <=7% at endpoint (for patients with HbA1c >7% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 7% . Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
2768102|NCT00753896|Secondary|Change in HbA1c From Baseline to Week 52|Change in HbA1c from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Mean
2768103|NCT00753896|Primary|Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.|||events per subject-year||Standard Error|Mean
2768104|NCT00753896|Primary|Percentage of Patients Experiencing Adverse Events|Percentage of patients experiencing treatment-emergent adverse events over 52 weeks|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.|||percentage of patients|||Number
2768106|NCT00753766|Secondary|Number of Participants Who Experience a Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia||6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||Participants|||Count of Participants
2768107|NCT00753766|Secondary|Length of Hospital Stay||6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||days|||Number
2768108|NCT00753766|Secondary|Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period||30 days|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||Participants|||Count of Participants
2768109|NCT00753766|Secondary|Change in A1c From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control])|A1c measured at two time points - baseline and 6 weeks later (pre-admission). This parameter is the difference between those two time points.|6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and data for this parameter were not collected. There were -0- participants enrolled in the Usual Care group.||||||
2768110|NCT00753766|Secondary|Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications||6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||percent of participants|||Number
2768111|NCT00753766|Secondary|Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)||6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||percent of participants|||Number
2768112|NCT00753766|Primary|Percent of Screened Participants That Are Eligible and Choose Participation||6 weeks|The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.|||percentage of potential participants|||Number
2768113|NCT00753714|Secondary|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes|Oct 2008- Dec 2011||||Adverse Events|||Number
2768114|NCT00753714|Secondary|Duration of Response||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
2768115|NCT00753714|Secondary|Overall Objective Response||Oct 2008- dec 2011||||Participants|||Number
2768116|NCT00753714|Secondary|Overall Survival||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
2768117|NCT00753714|Primary|Progression Free Survival||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
2768118|NCT00753688|Secondary|Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal [LLN]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).|Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
2768119|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin|Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
2768120|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count|Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
2768121|NCT00753688|Secondary|Change From Baseline in Heart Rate|Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||beats per minute||Standard Deviation|Mean
2768122|NCT00753688|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population: all participants who had started their allocated treatment (at least one dose of the study drug). Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||Millimeters of mercury||Standard Deviation|Mean
2768123|NCT00753688|Secondary|PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization [WHO] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)|"ITT Population. The ns in the category titles represent the number of participants in each treatment arm with the indicated STS."|||weeks||95% Confidence Interval|Median
2768124|NCT00753688|Secondary|Duration of Response Assessed by the Independent Radiologist and the Investigator|Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.|||weeks||95% Confidence Interval|Median
2768125|NCT00753688|Secondary|Time to Response Assessed by an Independent Radiologist and the Investigator|Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.|||weeks||95% Confidence Interval|Median
2768126|NCT00753688|Secondary|Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator|Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).|From the start of treatment until disease progression (assessed for an average of 10 months)|ITT Population|||participants|||Number
2768127|NCT00753688|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent [%]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.|From the date of randomization until 215 deaths (assessed for an average of 12 months)|ITT Population|||months||95% Confidence Interval|Median
2768128|NCT00753688|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)|Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization.|||weeks||95% Confidence Interval|Median
2768129|NCT00753675|Secondary|Overall Survival|OS is defined from the date of randomization to death|up to 1032 days|ITT|||Days||95% Confidence Interval|Median
2768130|NCT00753675|Secondary|Duration of Response (DOR)|DOR is defined from the date of first documentation of response until date of PD or death|up to 1032 days|ITT (best response of CR or PR only)|||Days||95% Confidence Interval|Median
2768131|NCT00753675|Secondary|Disease Control Rate (CR+PR+SD)|DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis|up to 1032 days|ITT|||Partecipants|||Number
2768132|NCT00753675|Secondary|Objective Tumor Response Rate (CR+PR),|Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD|up to 1032 days|ITT|||Participants|||Number
2768133|NCT00753675|Primary|Progression Free Survival|Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).|up to 1032 days|ITT|||days||95% Confidence Interval|Median
2768134|NCT00753649|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to Last subject last visit on 03/12/2013|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.|||Subjects|||Number
2768135|NCT00753649|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day (Days 0-30) post vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.|||Subjects|||Number
2768136|NCT00753649|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2768137|NCT00753649|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL|The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2768138|NCT00753649|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)|A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2768139|NCT00753649|Secondary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2768140|NCT00753649|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL|For this assay, 1 μg/mL was considered as the seropositivity cut-off.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2768141|NCT00753649|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2768142|NCT00753636|Secondary|Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine|Mean Plasma Concentration (+/- SD ng/mL)|1 year||||ng/mL||Standard Deviation|Mean
2768143|NCT00753636|Secondary|Change in Motor UPDRS Scores: Baseline vs. Final Visit|"Baseline visit = Week 0 Final visit = Week 12~Unified Parkinson's Disease Rating Scale (UPDRS)is made up of the following sections:~Part I: evaluation of Mentation, behavior, and mood Part II: self evaluation of the activities of daily life Part III: clinician-scored motor evaluation Part IV: Hoehn and Yahr stating of severity of Parkinson disease. Part V: Schwab and England ADL scale Only part three was used for this assessment.~The higher the UPDRS score, the greater the disability from PD.~The range for scores for Section III is 0 to 108."|12 weeks||||UPDRS Part III Score||Standard Deviation|Mean
2768144|NCT00753636|Secondary|Number of Participants That Completed the Study at Each Dose Level of Isradipine||1 year||||Participants|||Number
2768145|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent|"At the time of enrollment, some patients were currently being treated with antihypertensive agents including Propanolol, Toprol, Lisinopril, Diovan, Norvasc.~HTN+: Participants on an antihypertensive agent HTN-: Participants not on an antihypertensive agent"|1 year||||Participants|||Number
2768146|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose of Isradipine|Tolerability= maximum tolerated dose|1 year||||Participants|||Number
2768147|NCT00753636|Secondary|Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily||1 year||||Participants|||Number
2768148|NCT00753636|Primary|Tolerability of Isradipine Based on the Number of Participants That Complete the Study||1 year||||Participants|||Number
2768149|NCT00753623|Primary|Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments|Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.|VAS score at baseline and after the treatment period|Only 15 subjects completed both treatment phases so we only included these subjects in the analysis.|||units on a scale||Standard Deviation|Mean
2768150|NCT00753545|Secondary|Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
2768151|NCT00753545|Secondary|Trial Outcome Index(TOI)Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
2768152|NCT00753545|Secondary|FACT-O Symptom Index (FOSI) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
2768153|NCT00753545|Secondary|Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
2768154|NCT00753545|Secondary|Improvement Rate for Trial Outcome Index (TOI)|The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
2768155|NCT00753545|Secondary|Improvement Rate for FACT-O Symptom Index (FOSI)|The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
2768156|NCT00753545|Secondary|Time to Earlier of CA-125 or RECIST Progression|Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
2768157|NCT00753545|Secondary|RECIST and CA-125 Response Separately and Combined|RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.||||Participants|||Number
2768158|NCT00753545|Secondary|Best Objective Response|Best overall response from radiologic assessments. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.||||Participants|||Number
2768159|NCT00753545|Secondary|Best Percentage Change in Cancer Antigen 125 (CA-125) Levels|Best percentage change from baseline in CA-125 level|CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.|A subset of the FAS with baseline and at least 1 follow-up value of CA-125|||percentage of change||Full Range|Median
2768160|NCT00753545|Secondary|Percentage Change From Baseline in Tumour Size at Week 24|Percentage change from baseline to Week 24 in target tumour size.|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.|||Percent change in tumour size||Full Range|Least Squares Mean
2768161|NCT00753545|Secondary|Duration of Response|Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
2768162|NCT00753545|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]|Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).||||percentage of participants|||Number
2768163|NCT00753545|Secondary|Objective Response Rate (ORR) (According to RECIST)|For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline|||percentage of participants|||Number
2768165|NCT00753545|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
2768166|NCT00753519|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).|baseline, 1 day post iTBS||||units on a scale||Standard Deviation|Mean
2768167|NCT00753519|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|baseline, 1 day post iTBS||||units on a scale||Standard Deviation|Mean
2768168|NCT00753519|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post iTBS||||seconds||Standard Deviation|Mean
2768169|NCT00753519|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.|baseline, 1 day post iTBS||||seconds||Standard Deviation|Mean
2768170|NCT00753506|Secondary|Change in Cognitive Functioning as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Change in Functional Performance as Measured by the UCSD Performance-based Skills Assessment.||10 weeks (weeks 2 & 12)|||||||
2768171|NCT00753506|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale. PANSS positive symptom scores and negative symptom scores each range from 7 to 49 units on a scale.|10 weeks (weeks 2 & 12)||||units on a scale||Standard Deviation|Mean
2768172|NCT00753454|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."|||units on a scale||Standard Deviation|Mean
2768173|NCT00753454|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient's Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."|||units on a scale||Standard Deviation|Mean
2768174|NCT00753454|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
2768175|NCT00753454|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
2768204|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.|9 months|Intent to Treat population|||participants|||Number
2768176|NCT00753454|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
2768177|NCT00753454|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
2768178|NCT00753454|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
2768179|NCT00753454|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
2768180|NCT00753454|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
2768181|NCT00753454|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
2768182|NCT00753454|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
2768183|NCT00753454|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
2768184|NCT00753454|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|"Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
2768205|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.|30 days|Intent to Treat population|||participants|||Number
2774161|NCT00711009|Secondary|Mean Change From Baseline in Neutrophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2768185|NCT00753454|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."|||units on a scale||Standard Deviation|Mean
2768186|NCT00753454|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.~Data was not available for 16 subjects."|||percentage of subjects|||Number
2768187|NCT00753454|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.~Data was not available for 17 subjects."|||percentage of subjects|||Number
2768188|NCT00753454|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.~Data was not available for 19 subjects."|||percentage of subjects|||Number
2768189|NCT00753454|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.~Data was not available for 22 subjects."|||units on a scale||Standard Deviation|Mean
2768190|NCT00753454|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.~Data was not available for 23 subjects."|||units on a scale||Standard Deviation|Mean
2768191|NCT00753454|Secondary|Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."|||units on a scale||Standard Deviation|Mean
2768192|NCT00753454|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
2768193|NCT00753454|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
2768194|NCT00753454|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
2768195|NCT00753454|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|"A Serious Adverse Event is any untoward medical occurrence that at any dose~results in death,~is life threatening,~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect"|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
2768196|NCT00753454|Primary|Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
2768197|NCT00753454|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
2768198|NCT00753415|Secondary|Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)|An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.|From pre-vaccination to Week 69|Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.||||||
2768199|NCT00753415|Primary|Number of Participants With Adverse Events (AEs)|This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|All Participants as Treated (APaT) population; all participants who received at least one vaccination.|||Participants|||Number
2768200|NCT00753415|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.|||Participants|||Number
2768201|NCT00753363|Secondary|Fitness|Maximal oxygen consumption (VO2max) on a treadmill|Baseline and 6 month||||L/min||Standard Error|Mean
2768202|NCT00753363|Secondary|Body Weight||Baseline and 6 month||||kg||Standard Error|Mean
2768203|NCT00753363|Primary|Insulin Sensitivity|Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.|Baseline and 6 month||||μmol/kgFFM/min||Standard Error|Mean
2768206|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|9 months|Intent to Treat population|||percentage of limbs|Participants||Number
2768207|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|30 days|Intent to Treat population|||percentage of limbs|Participants||Number
2768208|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|9 months|Intent to Treat population|||percentage of limbs|Participants||Number
2768209|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|30 days|Intent to Treat population|||percentage of limbs|Participants||Number
2768210|NCT00753337|Secondary|Procedure Success|Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)|9 months|Intent to Treat population|||percentage of participants|||Number
2768211|NCT00753337|Secondary|Lesion Success|Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
2768212|NCT00753337|Secondary|Device Success|Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
2768213|NCT00753337|Secondary|Primary Patency Rate at 9 Months|Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
2768214|NCT00753337|Primary|Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).|Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.|9 months|Intent to Treat population (ITT)|||percentage of participants|||Number
2768215|NCT00753298|Primary|Subject's Sensation When Using Test Catheter|Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)|At 4 weeks||||Score on scale||Standard Deviation|Mean
2768216|NCT00753298|Primary|Subject's General Satisfaction With Test Catheter|Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)|At 4 weeks||||Score on scale||Standard Deviation|Mean
2768217|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter After Withdrawal|Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
2768218|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Withdrawal|Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
2768219|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Insertion|Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
2768220|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter Before Insertion|Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
2768221|NCT00753272|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains|In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.|At Day 21 of the first year (2008/2009) of the study.|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.|||Participants|||Count of Participants
2768222|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the second year of the study.|||Titers||95% Confidence Interval|Geometric Mean
2768232|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Days||Full Range|Mean
2768223|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study.|||Titers||95% Confidence Interval|Geometric Mean
2768224|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the second year of the study.|||Titers||95% Confidence Interval|Geometric Mean
2768225|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the first year of the study.|||Titers||95% Confidence Interval|Geometric Mean
2768226|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
2768227|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
2768228|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
2768229|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
2768230|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Days||Full Range|Mean
2768231|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
2768233|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
2768234|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Days||Full Range|Mean
2768235|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
2768236|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Days||Full Range|Mean
2768237|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
2768238|NCT00753272|Secondary|Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2768239|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2768240|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)|The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study|||Participants|||Count of Participants
2768241|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)|The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study.|||Participants|||Count of Participants
2768242|NCT00753272|Secondary|Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine|Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
2768243|NCT00753272|Secondary|Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.|The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
2768244|NCT00753272|Secondary|Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.|"Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough.~The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v)."|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
2768245|NCT00753272|Secondary|Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.|Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
2768246|NCT00753272|Secondary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
2768247|NCT00753272|Primary|Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset, which included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.|||Titers||95% Confidence Interval|Geometric Mean
2768248|NCT00753272|Primary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))|The One-Dose According-To-Protocol cohort for efficacy included eligible subjects from the One-Dose Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
2768249|NCT00753220|Primary|Maximum Tolerated Dose (MTD)|"PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.~ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD."|Up to 1 year||||intratumorally delivered cells|||Number
2768250|NCT00753142|Secondary|Number of Participants With Beta-cell Failure|Pancreatic beta-cells can adapt to insulin resistance during the early stages of diabetes but continuous exposure of beta-cells to prolonged hyperglycemia can cause irreversible damage due to glucotoxicity. This study aimed to evaluate whether hyperglycemia-induced reduced beta-cell failure was the result of beta-cell exhaustion or beta-cell desensitization, however, no participants experienced beta-cell failure so this original analysis could not be performed.|Hour 20||||Participants|||Count of Participants
2768277|NCT00752726|Secondary|Selectivity Index at Week 24|The selectivity index (SI) was used as a measure of orlistat's ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group.|||Ratio|||Number
2768251|NCT00753142|Primary|First-Phase Insulin Release (FPIR)|An arginine stimulation test was used to evaluate beta-cell function and insulin secretion. Increased glucose in the blood causes insulin to be released, beginning with a spike in insulin in the first 10 minutes and plateauing 2 to 3 later. Diminished first-phase insulin release is an early indicator of beta-cell dysfunction. Two sequential arginine stimulation tests were performed, the first set before and the second after completion of the 20-hour dextrose infusion. The first-phase insulin release (FPIR) was calculated as the sum of the insulin levels at 2, 3, 4, and 5 minutes after the arginine infusion. FPIR is expected to rise after the dextrose (glucose) infusion and FPIR generally rises less in persons with impaired glucose tolerance.|Hour 0, Hour 20||||microunits/ml||Standard Deviation|Mean
2768252|NCT00753012|Primary|Blood Pressure at Maximum Exertion|Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET)|3-6 months||||mmHg||Standard Deviation|Mean
2768253|NCT00753012|Primary|Cardiac Function Index (E/A Ratio)|Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months||||cm/sec/cm/sec||Standard Deviation|Mean
2768254|NCT00753012|Primary|Left Ventricle Size|Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment.|||mm||Standard Deviation|Mean
2768255|NCT00752986|Secondary|Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes||Continuous assessment of safety.|||||||
2768256|NCT00752986|Secondary|Overall Survival||Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.|||||||
2768257|NCT00752986|Secondary|Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)||Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.|||||||
2768258|NCT00752986|Primary|Event Free Survival|Success rate (patients without progression and still on treatment at 24 weeks|Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.|||||||
2768259|NCT00752973|Secondary|Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.|To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).|||participants|||Number
2768260|NCT00752973|Primary|Participants Clinically Cured of Head Lice 14 Days After Last Treatment|No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).|Day 7±1 and Day 14 or Day 21|No statistical analysis provided for Clinical Cure|||participants cured of lice|||Number
2768261|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 24 hrs (Day 1)||||percentage of participants|||Number
2768262|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 1 hr (Day 0)||||percentage of participants|||Number
2768263|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participant had wheezing as medical history which continued without increase in severity throughout the treatment."|at Baseline||||percentage of participants|||Number
2768264|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).|"Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100."|Change from baseline to 24 hrs (1 day)|11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.|||percentage change in cholinesterase||95% Confidence Interval|Mean
2768278|NCT00752726|Secondary|Change From Baseline to Week 24 in Quality of Life (QoL) Scores.|QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.|Baseline to week 24|This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
2768265|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).|"Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.~If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100."|Change from Baseline to 1 hour|"10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0.~subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts."|||percentage change in cholinesterase||95% Confidence Interval|Mean
2768266|NCT00752908|Secondary|Cefoxitin Tissue Concentrations|Cefoxitin tissue concentrations|8 hours||||(µg/mL)||Standard Deviation|Mean
2768267|NCT00752908|Primary|Cefoxitin Plasma Concentrations|Cefoxitin plasma concentrations|8 hours||||(µg/mL)||Standard Deviation|Mean
2768268|NCT00752895|Secondary|Number of Antibiotic Use Days|An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.|3 months|Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.|||days||Standard Deviation|Mean
2768269|NCT00752895|Primary|Acute Respiratory Infection (ARI) Days|An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.|3 months|Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.|||days||Standard Deviation|Mean
2768270|NCT00752791|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 25|Safety Analysis Set. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.|||percentage of participants|||Number
2768271|NCT00752791|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 25 weeks.|Full analysis set where data was available for each time interval (indicated by N).|||percentage of participants||95% Confidence Interval|Number
2768272|NCT00752791|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.|Up to 25 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).|||g/dL||Standard Deviation|Mean
2768273|NCT00752791|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.|Up to 25 weeks.|Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
2768274|NCT00752791|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.|Baseline and Week 20 to Week 25.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
2768275|NCT00752791|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 20 to Week 25.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
2768276|NCT00752791|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).|Baseline and Week 20 to Week 25.|The Full Analysis Set included all patients who received at least 1 dose of peginesatide injection and where data was available at both time points (indicated by N).|||g/dL||Standard Deviation|Mean
2768279|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Calories Expended for Physical Activity|Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Kilocalorie (kcal)/week||Standard Deviation|Mean
2768281|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Liver Fat|For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).|Baseline to week 24|ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.|||Percentage (%) IHL||Standard Deviation|Mean
2768282|NCT00752726|Secondary|Change From Baseline to Week 24 in Waist Circumference|Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||cm||Standard Deviation|Mean
2768283|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Body Fat|Body fat was assessed through Bioelectrical Impedance Analysis (BIA).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Percentage (%) body fat||Standard Deviation|Mean
2768284|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Fat Mass|Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
2768285|NCT00752726|Secondary|Change From Baseline to Week 24 in Body Weight|Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
2768286|NCT00752726|Secondary|Change From Baseline to Week 12 in Abdominal VAT Mass|Abdominal VAT mass from baseline to week 12 was measured by CT scan.|Baseline to week 12|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
2768287|NCT00752726|Primary|Change From Baseline to Week 24 in Abdominal VAT Mass|VAT was measured by the computed tomography (CT) scan.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
2768288|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase|"Number of participants who were in clinical remission and off systemic corticosteroids at visit.~The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
2768289|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
2768290|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 100-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
2768291|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 70-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at week 14-16 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
2768292|NCT00752622|Secondary|Number of Participants That Required Treatment Optimization in the Observational Phase|"Participants required treatment-optimization if:~Disease progression/lack of response after entering observational phase; or~Participant was successfully randomized into the interventional phase~The definition of loss of response was as follows:~- An increased HBI score >= 3 points over the week 10 evaluation score and a CDAI score >= 175.~Despite:~having received regular infusions of infliximab every 8 weeks during the observational phase with a maximum interval of no > 10 weeks between each infusion, and~having received previous doses of infliximab of >= 4.7 mg/kg."|Week 54 in the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication. Of the 98 participants in the ELIG population, 65 participants entered the observational phase.|||Participants|||Number
2768293|NCT00752622|Primary|Mean Change From Baseline in Harvey-Bradshaw Index (HBI)|Mean change in HBI score from Baseline to Week 10, 30, and 54. HBI score consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is the sum of individual parameters. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools. Lower scores indicate better well being. Clinical response/ long-term response is defined as a decrease by 3 or more points from baseline value. Loss of response is defined as an increase of >= 3 points.|Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2768294|NCT00752622|Primary|Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase|The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Participants provided completed CDAI diary cards and were considered as responders in the interventional phase if their CDAI score at week 24 was decreased by 70 points or greater over their CDAI score at randomization into the interventional phase, or if their week 24 CDAI score is <= 150. Baseline is value at randomization.|Baseline and Week 24 of the Interventional phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
2768295|NCT00752609|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 20|Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.|||percentage of participants|||Number
2768296|NCT00752609|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full analysis set where data was available for each time interval (indicated by N).|||percentage of participants||95% Confidence Interval|Number
2768297|NCT00752609|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).|Up to 24 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).|||g/dL||Standard Deviation|Mean
2768298|NCT00752609|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
2768299|NCT00752609|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|"Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Baseline and Week 19 to Week 24.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
2768300|NCT00752609|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 19 to Week 24|Full Analysis Set where data was available.|||percentage of participants||95% Confidence Interval|Number
2768301|NCT00752609|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).|Baseline and Week 19 to Week 24.|The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N).|||g/dL||Standard Deviation|Mean
2768302|NCT00752557|Secondary|Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip|Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.|36 months|As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2768303|NCT00752557|Primary|Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck|Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.|At Month 12|As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.|||mg/cm^3||Standard Deviation|Mean
2768304|NCT00752557|Secondary|Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline|Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.|Baseline up to 12 months|As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).|||participants|||Number
2768707|NCT00748566|Secondary|Change From Baseline in Weight at Week 4,12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||kilogram (kg)||Standard Deviation|Mean
2768305|NCT00752557|Secondary|Number Participant Responses to Injectability Questionnaire Injected Population|Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.|Participants were monitored after treatment administration (dosing period)|Only those participants who were injected with rhBMP-2/CPM were included in the injected population. Any participant who received SOC alone was excluded from this population.|||Participants|||Number
2768306|NCT00752557|Secondary|Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)|Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.|24 months|As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.|||mg/cm^3||Standard Deviation|Mean
2768307|NCT00752557|Primary|Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip|Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).|At Month 12|As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.|||milligram per centimeter cubed (mg/cm^3)||Standard Deviation|Mean
2768308|NCT00752557|Primary|Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)|Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.|Baseline, 12 months post dose|As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.|||gram per centimeter squared (g/cm^2)||Standard Deviation|Mean
2768309|NCT00752232|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
2768310|NCT00752232|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Z-score||Standard Deviation|Mean
2768311|NCT00752232|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
2768323|NCT00752219|Secondary|Number of Participants With Microbiological Response at the End of IV Therapy|Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.|End of IV therapy: From Day 5 to Day 14|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
2768312|NCT00752232|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
2768313|NCT00752232|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geometric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
2768314|NCT00752232|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
2768315|NCT00752232|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
2768316|NCT00752232|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
2768317|NCT00752232|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
2768318|NCT00752219|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
2768319|NCT00752219|Secondary|Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
2768320|NCT00752219|Secondary|Number of Participants With Clinical Response in CE Participants at the End of IV Therapy|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|End of IV therapy: From Day 5 to Day 14|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
2768321|NCT00752219|Secondary|Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|Test of cure visit: 2 weeks post-therapy (Day 28)|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
2768322|NCT00752219|Secondary|Number of Participants With Microbiological Response at the Late Follow-up Visit|Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
2768373|NCT00751777|Secondary|Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group|GMFR|13 months||||ratio||95% Confidence Interval|Geometric Mean
2768374|NCT00751777|Secondary|Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group|GMT|13 months||||GMT||95% Confidence Interval|Geometric Mean
2768324|NCT00752219|Secondary|Number of Participants With Microbiological Response at the Test of Cure Visit|Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.|Test of cure visit: 2 weeks post-therapy (Day 28)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
2768325|NCT00752219|Secondary|Number of Participants With Clinical Response at the Late Follow-up Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
2768326|NCT00752219|Secondary|Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.|End of IV therapy: From Day 5 to Day 14|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
2768327|NCT00752219|Primary|Number of Participants With Clinical Response at the Test of Cure (TOC) Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.|Test of cure visit: 2 weeks post-therapy (Day 28)|ME set:clinically evaluable(CE)subset with atleast 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. CE set:participants diagnosed with intraperitoneal infection confirmed by operative findings with adequate therapy and information to determine clinical outcome at specified visit.|||participants|||Number
2768328|NCT00752206|Secondary|Number of Mutations Identified That May be Causative For Recurrent Osteosarcoma|To perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma. The methodology uses transcriptome sequencing, exon re-sequencing and mate-pair end sequencing, allowing us to detect translocations. The availability of matched normal DNA in the blood will allow us to determine which changes are unique to the tumor.|Up to 12 months||||identified mutations|||Number
2768329|NCT00752206|Secondary|Cell Lines and Murine Xenografts From Recurrent Tumor Samples|To establish cell lines and murine xenografts from recurrent tumor samples.|Up to 12 months|This testing was not performed.||||||
2768330|NCT00752206|Secondary|Biomarkers Related to Activation of Src and Src Substrates|To evaluate tumor samples for biomarkers related to activation of Src and Src substrates.|Up to 12 months|This testing was not performed.||||||
2768331|NCT00752206|Secondary|Number of Genes Identified for Prediction of Recurrence of Osteosarcoma|To perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma using methodology that relies on preparation of RNA, followed by cDNA. Fluorescent labeling followed by hybridization to a DNA chip allows for quantitative scanning for hybridized complexes.|Up to 12 months||||identified genes|||Number
2768332|NCT00752206|Secondary|Change in Time to Treatment Failure With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy|To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in the time to treatment failure. Time to treatment failure is the time from randomization to treatment discontinuation.|Up to 12 months|Did not perform time to progression analysis, but rather evaluated PFS. There was no data to report for time to treatment failure.||||||
2768333|NCT00752206|Secondary|Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy|To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in overall survival.|5 year overall survival||||months||85% Confidence Interval|Median
2768334|NCT00752206|Primary|Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.|To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.|Evaluation for recurrence/progression will be made every 3 months for the 1st year, then every 6 months up to 2 years, then every year up to 5 years after starting treatment.|38 subjects were randomized to receive therapy. One randomized subject was subsequently taken off-study for pregnancy; therefore 37 subjects were included in the analysis.|||months||Inter-Quartile Range|Median
2768335|NCT00752128|Secondary|Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition||12 Months|Intention to treat|||percentage of participants|||Number
2768336|NCT00752128|Primary|Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)||12 Months|Analysis per intention to treat|||percentage of participants|||Number
2768337|NCT00752102|Primary|Coronary Artery (CAC) Score Progression|"coronary artery (CAC) score difference between baseline and followup CT scans. It was measured in Agatston units. These are units of amount of calcification in the blood vessels so it's a continuous variable. The amount of calcium was quantified with the Agatston scoring method. Calcium scores were adjusted with a standard calcium phantom that was scanned along with the participant. The phantom contained known calcium density bars and provided a way to calibrate the x-ray attenuation level.~Participants scoring CAC >400 are considered to be at risk for having at least one coronary lesion."|48 weeks||||Agatston units||Standard Deviation|Mean
2768375|NCT00751777|Secondary|Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear||1 month|Summary statistics are only shown for the LT Group in a protocol pre-defined subset of subjects, results for the Placebo Group were below the Limit of detection in all cases|||nanograms (ng)||Standard Deviation|Mean
2768338|NCT00752089|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."|||ug*F/cm^3||95% Confidence Interval|Least Squares Mean
2768339|NCT00752089|Primary|Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."|||% SMHR||95% Confidence Interval|Least Squares Mean
2768340|NCT00751998|Secondary|Health Resources Utilization (Health Economics)||Procedure through end of study.|||||||
2768341|NCT00751998|Secondary|Device Durability and Device Performance.||Procedure|||||||
2768342|NCT00751998|Secondary|Safety||Procedural through end of study|||||||
2768343|NCT00751998|Secondary|Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures.||Post Procedure|||||||
2768344|NCT00751998|Secondary|Ability to Visualize and Access Various Targeted Anatomic Areas.||Procedure|||||||
2768345|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management.||Procedure or at 12 months|||||||
2768346|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis.||Procedural through end of study|||||||
2768347|NCT00751998|Primary|Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.||During Procedure||||percent||95% Confidence Interval|Number
2768348|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D|"The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.~The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.~Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL|||units on a EuroQol EQ-5D scale||Standard Deviation|Mean
2768349|NCT00751972|Secondary|Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days|"The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.~A longer distance walked is indicative of a better outcome."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of 6 minute walk distance.|||meters||Standard Deviation|Mean
2768350|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|"KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQ's questions are used to calculate scores in ten domains:~Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL.|||units on a KCCQ scale||Standard Deviation|Mean
2768351|NCT00751972|Secondary|Incidence of All Device Failures and Device Malfunctions|The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Number of events|||Number
2768352|NCT00751972|Secondary|Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects|Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||percentage of patients|||Number
2768353|NCT00751972|Secondary|Survival to 180 Days|All subjects will be followed for date of death until 180 days.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Percentage of participants with survival|||Number
2774162|NCT00711009|Secondary|Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2768354|NCT00751972|Primary|The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.|The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.|180 days|The primary effectiveness analyses was performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Percentage of participants with success|||Number
2768355|NCT00751933|Secondary|Symptom Score Improvement of 2 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months|||||||
2768356|NCT00751933|Primary|Symptom Score Improvement of 3 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months|||||||
2768357|NCT00751881|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."|||participants|||Number
2768358|NCT00751881|Secondary|Extension Treatment Period: ARR: Poisson Regression Estimate|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. A relapse is defined as the appearance of a new clinical sign/symptom or clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persists for a minimum of 24 hours in the absence of fever. Relapse was confirmed by an increase in EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.|||relapses per year||95% Confidence Interval|Number
2768359|NCT00751881|Secondary|Extension Treatment Period: Time to Disability Progression|"Probability of disability progression since the randomization of the core period was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12 week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event free for the amount of time t. Probability of event at time t was 1 minus the probability of being event-free for the amount of time t."|Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.|||percent probability||95% Confidence Interval|Number
2768360|NCT00751881|Secondary|Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|"Safety population: all randomized participants who received at least 1 dose of investigational product.~Two participants in placebo of core study received teriflunomide and were analyzed according to teriflunomide dose.~One participant in teriflunomide 14 mg in core study group who received 7 mg was analyzed in teriflunomide 7 mg group."|||participants|||Number
2768361|NCT00751881|Secondary|Core Treatment Period: Overview of Adverse Events|Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."|||participants|||Number
2768362|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2768376|NCT00751777|Secondary|Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch|LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)|13 months||||Participants|||Count of Participants
2768644|NCT00749190|Secondary|Trough Concentrations of Empagliflozin in Plasma|(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2768363|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|"SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.~Two summary scores are obtained:~the physical health component summary score,~the mental health component summary score.~Both scores range from 0 to 100 and a high score indicates a more favorable health state.~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures [MMRM] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2768364|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2768365|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score|"FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2768366|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score|"EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.~EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).~Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2768367|NCT00751881|Secondary|Core Treatment Period: Time Without Relapse|"Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.~Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population|||percent probability||95% Confidence Interval|Number
2768368|NCT00751881|Secondary|Core Treatment Period: Time to Disability Progression|"Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population|||percent probability||95% Confidence Interval|Number
2768369|NCT00751881|Primary|Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate|"ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||relapses per year||95% Confidence Interval|Number
2768370|NCT00751790|Secondary|LH Increase|% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts|day 1 and day 169|||||||
2768371|NCT00751790|Primary|Achievement of Castration and Maintenance of Castration|Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).|at Day 29||||percentage of enrolled patients|||Number
2768372|NCT00751777|Secondary|Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group|SCR|13 months||||percentage of participants||95% Confidence Interval|Number
2768377|NCT00751777|Primary|Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|"Definition of SCR:~Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline~Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline"|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||percentage of participants||95% Confidence Interval|Number
2768378|NCT00751777|Primary|Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||ratio||95% Confidence Interval|Number
2768379|NCT00751777|Primary|Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo||Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2768380|NCT00751634|Secondary|Number of Participants With Arrhythmia|New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm|Six hours||||participants|||Number
2768381|NCT00751634|Secondary|Number of Participants With Hypotension|New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period|six hours||||participants|||Number
2768382|NCT00751634|Secondary|Number of Participants With Severe Shivering|"Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall~Mild: shivering localized to the neck and/or thorax only~Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)~Severe: shivering involves gross movements of the trunk and upper and lower extremities"|six hours|All participants were analyzed for the outcome of BSAS=3|||participants|||Number
2768383|NCT00751634|Secondary|Time From Start of Cooling Device to Core Temperature < 100.4F|For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F|Six hours||||hours||Standard Deviation|Mean
2768384|NCT00751634|Primary|Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care|Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.|baseline, one, two and six hours after application.||||degrees F||Standard Deviation|Mean
2768385|NCT00751621|Secondary|Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion|The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period.|||AEs per infusion|Participants||Number
2768386|NCT00751621|Secondary|Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.|The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion.|||participants|||Number
2768387|NCT00751621|Secondary|Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.|The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion.|||participants|||Number
2768388|NCT00751621|Secondary|Health Related Quality of Life (Short Form 36 Health Survey)|The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At baseline and at the last available post-baseline observation for each subject (up to 42 months)|The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.|||score on a scale||Full Range|Median
2768389|NCT00751621|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
2768645|NCT00749190|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||kg||Standard Error|Mean
2768390|NCT00751621|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days|||Number
2768391|NCT00751621|Secondary|Annualized Rate of Hospitalization Due to Infections|The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
2768392|NCT00751621|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days|||Number
2768393|NCT00751621|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
2768394|NCT00751621|Secondary|Number of Infection Episodes|Total number of infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||infection episodes|||Number
2768395|NCT00751621|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||infection episodes per subject year|Participants|95% Confidence Interval|Number
2768396|NCT00751621|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs."|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||SBIs per subject year|Participants||Number
2768397|NCT00751621|Primary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Up to 42 months|The “all treated” (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the “Full Analysis/intention-to-treat” (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||g/L||Standard Deviation|Mean
2768398|NCT00751530|Secondary|Percentage of Participants Using Etravirine in Background Regimen|These results report the percent of participants using Etravirine in the background regimen.|Background regimen (no specific time frame)||||Percentage of Participants|||Number
2768399|NCT00751530|Primary|Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 Weeks||||Percentage of Participants|||Number
2768400|NCT00751530|Secondary|Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)|The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.|Baseline||||score||Full Range|Mean
2768401|NCT00751530|Secondary|CD4 Cell Changes Among Participants in PI vs Non-PI Group|CD4 cell counts were measured using standard of care testing via local laboratories.|baseline to 24 Weeks||||cells/mm3||Full Range|Mean
2768402|NCT00751530|Secondary|Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 weeks||||Percentage of participants|||Number
2768403|NCT00751400|Secondary|Number of Dosing Occasions Per Subject That Exceeded 660 mg|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions||Standard Deviation|Mean
2768646|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU / mmol||Standard Error|Mean
2768404|NCT00751400|Secondary|Number of Total Dosing Occasions Per Subject|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions||Standard Deviation|Mean
2768405|NCT00751400|Secondary|Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days|This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing|1 month|number of subjects reporting at least one tablet taken at any point during study|||participants|||Number
2768406|NCT00751400|Secondary|Average Daily Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||mg||Standard Deviation|Mean
2768407|NCT00751400|Secondary|Number of Subjects With and Without More Than 660 mg at Least Once|This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
2768408|NCT00751400|Secondary|Number of Subjects With and Without Next Dose Less Than 22 Hours Later|This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
2768409|NCT00751400|Secondary|Number of Subjects With and Without More Than One Tablet Taken Per Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
2768410|NCT00751400|Secondary|Use Days With and Without Next Dose Less Than 22 Hours Later|Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||days|||Number
2768411|NCT00751400|Secondary|Dosing Occasions With One and More Than One Tablet Taken|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions|||Number
2768412|NCT00751400|Primary|Use Days With One or More Misuse Occasions|Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||days|||Number
2768413|NCT00751348|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 up to Day 43 or Day 57)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2768414|NCT00751348|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2768415|NCT00751348|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
2768416|NCT00751348|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.|||Participants|||Count of Participants
2768417|NCT00751348|Secondary|Antibody Titers Against Varicela Viruses|Antibody titers were presented as geometric mean titers (GMTs).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
2768418|NCT00751348|Secondary|Antibody Concentrations Against Rubella|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2768419|NCT00751348|Secondary|Antibody Concentrations Against Mumps|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||U/mL||95% Confidence Interval|Geometric Mean
2768420|NCT00751348|Secondary|Antibody Concentrations Against Measles|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2768421|NCT00751348|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values|Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.|At 42 days post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
2768422|NCT00751296|Secondary|Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).|Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with >55% prolymphocytes)).|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.||||percentage of participants||95% Confidence Interval|Number
2768423|NCT00751296|Primary|To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)|"The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.~Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with <30% lymphocytes.~Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets > 100 x109/L or 50% improvement over baseline, hemoglobin > 110 g/L or 50% improvement over baseline (without transfusion)."|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|Severe toxicities were seen in the first two patients enrolled on the initial protocol. The study was halted and the protocol amended to use a starting dose of lenalidomide 2.5 mg with monthly escalations to a target dose of 10 mg, extended tumor lysis prophylaxis and monitoring. 25 response evaluable patients were enrolled on the amended protocol.|||participants|||Number
2768424|NCT00751179|Secondary|Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.|Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)|Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.|||Minutes||95% Confidence Interval|Geometric Mean
2768425|NCT00751179|Secondary|Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)|Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.|||Minutes||95% Confidence Interval|Geometric Mean
2768426|NCT00751179|Secondary|Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups|"Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered pretreatment events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure)."|Up to 7 days post dose|Participants who received sugammadex or succinylcholine.|||participants|||Number
2768427|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768428|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768429|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768430|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768431|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768432|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768433|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768434|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
2768435|NCT00751140|Secondary|Surgical Outcomes: Mean Lymph Node Count|The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).|2 years|Total Participants and Participants Per Procedure Category|||Lymph Nodes||Full Range|Mean
2768436|NCT00751140|Primary|Number of Participants With Pathologically Proven Lymph Node Metastasis|"The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND).~The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer."|Up to 4 years|All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.|||participants|||Number
2768437|NCT00751114|Secondary|Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)|||participants|||Number
2768438|NCT00751114|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)|||participants|||Number
2768439|NCT00751114|Secondary|Change in Body Weight From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||kg||Standard Error|Least Squares Mean
2768440|NCT00751114|Secondary|Lipid Profile: Change From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
2768441|NCT00751114|Secondary|Insulin Dose in the Insulin Glargine Group|Daily dose at the face-to-face visits.|visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value|The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.|||unit per kg body weight||Standard Deviation|Mean
2768442|NCT00751114|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
2768443|NCT00751114|Secondary|Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Study endpoint was defined as the last available SMFPG mean value collected on-treatment.~Change= study endpoint - baseline"|baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
2768444|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.|||percentage of participants|||Number
2768445|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.|||percentage of participants|||Number
2768459|NCT00750919|Primary|Number of Participants Discontinuing Due to AEs|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 26 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Participants|||Number
2768446|NCT00751114|Primary|HbA1c: Change From Baseline to Study Endpoint|Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value."|||percent||Standard Error|Least Squares Mean
2768447|NCT00751036|Secondary|Overall Survival (OS)|. OS is defined as the time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.|time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Days||95% Confidence Interval|Median
2768448|NCT00751036|Secondary|Time to Treatment Failure|TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.|Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Days||95% Confidence Interval|Median
2768449|NCT00751036|Secondary|Disease Control Rate (DCR)|The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).|every 2 months until 24 months (end of study)|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Percentage of Patients||95% Confidence Interval|Number
2768450|NCT00751036|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|24 months|Full Analysis Set (FAS) consisted of all randomized patients. Following the intent to treat principle, patients were analyzed according to the treatment which they were assigned at randomization.|||Days||95% Confidence Interval|Median
2768451|NCT00751023|Secondary|Percentage Change in Beck Depression Inventory Scores|Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome.|5 weeks|Note: Total number of study completers = 22 (9 in Modafinil group and 13 in Placebo group). Beck Depression Inventory Scores at study endpoint were obtained in only 20 of 22 study completers (9 participants assigned to Modafinil and 11 participants assigned to Placebo).|||Percent change||Standard Deviation|Mean
2768452|NCT00751023|Secondary|Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint|Percent change in scores (T scores) on the Shipley Abstract subscale from baseline to study endpoint (Week 5) in study completers; T scores min=0, max=100; larger positive values indicate better outcome.|5 weeks||||T scores, percent change||Standard Deviation|Mean
2768453|NCT00751023|Secondary|Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint|Percent change of T scores from baseline to study endpoint (Week 5) in study completers; T score min=0, max=100; higher scores (more positive change) indicate better outcome.|5 weeks||||Percent change, baseline-study endpoint||Standard Deviation|Mean
2768454|NCT00751023|Secondary|Score on the Wisconsin Card Sort Test|Scores (T scores) on the Wisconsin Card Sort Test (total errors) at study endpoint (Week 5) in study completers, adjusted for age and education; min=0, max=100, higher numbers indicate better outcomes.|5 weeks|Note: Total number of study completers = 22 (9 in Modafinil group and 13 in Placebo group). The Wisconsin Card Sort Test was able to be completed in only 19 of 22 study completers (8 participants assigned to Modafinil and 11 participants assigned to Placebo).|||T scores at study endpoint||Standard Deviation|Mean
2768455|NCT00751023|Secondary|Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint|Mean percent change of T scores from baseline to study endpoint (Week 5) in study completers. Min T score = 0, max T score = 100. Higher scores, greater (more positive) percent change indicate better outcomes.|5 weeks||||Percent change, baseline-study endpoint||Standard Deviation|Mean
2768456|NCT00751023|Secondary|Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint|Mean percent change in T scores from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes.|5 Weeks||||Percent change, baseline-study endpoint||Standard Deviation|Mean
2768457|NCT00751023|Secondary|Percent Change in California Verbal Learning Test From Baseline to Study Endpoint|Mean percent change in T scores (average total score of 6 trials) from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes.|Study baseline to study endpoint (Week 5)||||Percent change, baseline-study endpoint||Standard Deviation|Mean
2768458|NCT00751023|Primary|Percentage of Participants With Methamphetamine-positive Urine Drug Screens|Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5)|5 weeks||||Percentage of participants|||Number
2768460|NCT00750919|Primary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 30 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Participants|||Number
2768461|NCT00750919|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded for sleep diary question 5 how much time were you awake, after falling asleep initially as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
2768462|NCT00750919|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded for sleep diary question 3 how long did it take you to fall asleep',  as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
2768463|NCT00750919|Primary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded for sleep diary question 6 how much time did you actually spend sleeping as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
2768464|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|During the post-marketing study period for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available for Year 1 to Year 6 study period.|||Participants|||Count of Participants
2768465|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|During the post-marketing study period for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 5.|||Participants|||Count of Participants
2768466|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|During the post-marketing study period for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 3 and Year 4.|||Participants|||Count of Participants
2768467|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|During the post-marketing study period for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 1 and Year 2.|||Participants|||Count of Participants
2768468|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available for the Year 1 to Year 6 study period.|||Participants|||Count of Participants
2768557|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score|SDAS total scores ranged from 0 (not present) to 44 (extremely severe). Participants exceeding the threshold had a SDAS total score of more than 6 out of 44.|Baseline B (Week 2) to Week 4 (Period BC)|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768469|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 5.|||Participants|||Count of Participants
2768470|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 3 and Year 4.|||Participants|||Count of Participants
2768471|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.|||Participants|||Count of Participants
2768472|NCT00750893|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.|During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.|||Participants|||Count of Participants
2768473|NCT00750880|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit|FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2768474|NCT00750880|Secondary|Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit|The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2768475|NCT00750880|Primary|Percentage of Participants With Adverse Events (AEs): Overall Summary|Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.|Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants included in the study who received at least 1 dose of study medication and who had at least 1 postbaseline assessment of safety (post-baseline laboratory data, vital signs, or adverse events). number (n) equals (=) number of participants analyzed for the parameter within the specific population.|||percentage of participants|||Number
2768476|NCT00750880|Secondary|Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2768477|NCT00750880|Secondary|HAQ-DI Scores by Visit|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2768478|NCT00750880|Secondary|Erythrocyte Sedimentation Rate by Visit|ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2768479|NCT00750880|Secondary|C-Reactive Protein by Visit|The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2768585|NCT00749931|Post-Hoc|Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens||Up to 2 months post-surgery||||percentage of participants|||Number
2768480|NCT00750880|Secondary|Patient's Global Assessment of Pain by Visit|"The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as no pain and the right-hand extreme=100 mm as unbearable pain. The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2768481|NCT00750880|Secondary|Physician's Global Assessment of Disease Activity by Visit|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as maximum disease activity (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2768482|NCT00750880|Secondary|Patient's Global Assessment of Disease Activity by Visit|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as maximum disease activity (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2768483|NCT00750880|Secondary|Tender Joint Count by Visit|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the last observation carried forward (LOCF) approach.|||tender joints||Standard Deviation|Mean
2768484|NCT00750880|Secondary|Swollen Joint Count by Visit|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the LOCF approach.|||swollen joints||Standard Deviation|Mean
2768485|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.|Weeks 4, 8, 12, 16, 20, and 24|ITT population; only participants with a response (ACR20/ACR50/ACR70/ACR90) were included in the analysis. n=number of participants with a response for the specified parameter|||days||95% Confidence Interval|Median
2768486|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||participants|||Number
2768487|NCT00750880|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||percentage of participants|||Number
2768488|NCT00750880|Secondary|DAS28 Scores by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2768489|NCT00750880|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||percentage of participants|||Number
2768607|NCT00749606|Primary|Weight|Weight (kg)|baseline, 1, 2, 3 years||||kg||Standard Deviation|Mean
2768490|NCT00750880|Secondary|Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event|The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.|Baseline,Weeks 4, 8, 12, 16, 20, and 24|ITT population with DAS28 ≤3.2|||days||Full Range|Median
2768491|NCT00750880|Secondary|Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; Only population with complete DAS28 data were analyzed.|||participants|||Number
2768492|NCT00750880|Secondary|Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; no imputation of missing data was performed for this analysis.|||percentage of participants|||Number
2768493|NCT00750867|Secondary|Preliminary Efficacy of IVIg for Treatment of MSA.|The secondary outcome measure was to evaluate the preliminary efficacy of IVIG for the treatment of MSA. The primary efficacy endpoint was change of the Unified MSA Rating Scale (UMSARS-I and UMSAR-II) compared to baseline. UMSARS-I and UMSARS-II are validated semiquantitative rating scales for evaluation of severity of MSA. UMSARS-I comprises a historical review of disease-related impairments and UMSARS-II comprises motor examination. UMSARS-I has 12 questions, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-I is 0 to 48. UMSARS-II has 12 items rated by an examiner, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-II is 0 to 56. The scores of UMSARS-I and UMSARS-II at baseline (month 1) was compared with the scores obtained at the final visit (month 8) which was 8 months apart. The interventions occured at months 2-7, total six times.|Monthly, up to 8 months (including the screening visit and the final visit)||||units on a scale||Standard Deviation|Mean
2768494|NCT00750867|Primary|Number of Adverse Events up to Six Months Post-treatment|The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.|Monthly, up to 8 months (including the screening visit and the final visit)|Two participants dropped out from the study.|||Adverse events|||Number
2768495|NCT00750815|Secondary|Phase II: Two Year Overall Survival (OS)|Overall survival by disease risk stratification after CVDD. OS: time from initiation of therapy until death from any cause.|2 years|Participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification.|||percentage of participants||95% Confidence Interval|Number
2768496|NCT00750815|Secondary|Phase II: Progression-Free Survival (PFS)|"Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes.~Progressive Disease (PD): Progressive Disease requires any one or more of the following:~Increase of ≥ 25% from baseline in:~serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL)~urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)"|Up to 50.9 months||||months||95% Confidence Interval|Median
2768497|NCT00750815|Primary|Phase II: Overall Response Rate (ORR)|Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.|Up to 6 months|All Participants with Partial Response, Very Good Partial Response, or Complete Response.|||participants|||Number
2768498|NCT00750815|Primary|Phase I - Maximum Planned Dose (MPD) Level|"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.~If no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants."|9 months|All participants in Arm A. Three participants at each dose level.|||Dosing Level|||Number
2768608|NCT00749580|Secondary|Virologic Suppression of < 75 Copies/ml at 48 Weeks||at 48 weeks for each patient||||participants|||Number
2768647|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L x mmol/L||Standard Error|Mean
2768499|NCT00750737|Secondary|Efficacy Outcome Measured as Success or Failure|Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).|Day 1 through Day 42|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.|||percentage of participants|||Number
2768500|NCT00750737|Primary|Incidence of Invasive Fungal Infection (IFI)|Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).|Within 7 days of antifungal prophylaxis therapy|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.|||percentage of participants|||Number
2768501|NCT00750555|Secondary|Overall Survival|Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.|2 years|Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.||||||
2768502|NCT00750555|Primary|One Year Disease Free|Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table.|1 year|Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.||||||
2768503|NCT00750438|Secondary|Insulin Sensitivity - HOMA IR|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.|24 weeks||||percentage of Beta Cell Function||Standard Deviation|Mean
2768504|NCT00750438|Secondary|Adipose Tissue Distribution - Intra-abdominal Adipose Tissue|Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.|24 weeks|MRS data could not be collected in 17 subjects, due to metal implants (n=8) and claustrophobia (n=9).|||percentage of total adipose tissue||Standard Error|Mean
2768505|NCT00750438|Primary|Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight|Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.|Baseline, 24 weeks||||Participants|||Count of Participants
2768506|NCT00750438|Primary|Body Weight|Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.|Baseline, 24 weeks||||kg||Standard Error|Mean
2768507|NCT00750438|Primary|Appetite_Food Intake|The change in food intake following 24 weeks of supplementation|Baseline, 24 weeks||||kcal||95% Confidence Interval|Mean
2768508|NCT00750373|Secondary|Readmission Due to Development of Congestive Heart Failure||up to 6 months after enrollment|||||||
2768509|NCT00750373|Secondary|All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies||up to 6 months after enrollment|||||||
2768510|NCT00750373|Secondary|Recurrences of Infective Endocarditis||up to 6 months after enrollment|||||||
2768511|NCT00750373|Secondary|All-cause Death||up to 6 month after enrollment|||||||
2768512|NCT00750373|Primary|Number of Participants With In-hospital Death or Clinical Embolic Events|The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.|within 6 weeks from the randomization|intention to treat analysis|||participants|||Number
2768513|NCT00750360|Secondary|Number of Participants Reporting Serious Adverse Events (SAE).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Within 1 month following vaccination||||participants|||Number
2768514|NCT00750360|Secondary|Number of Participant Reporting Unsolicited Adverse Events.|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day follow-up period (Day 0 to Day 20) after vaccination||||participants|||Number
2768515|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.||||participants|||Number
2768516|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.||||participants|||Number
2768517|NCT00750360|Primary|Number of Participants Reporting Severe Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities"|During the 21-day follow-up period (Day 0 to Day 20) after vaccination||||participants|||Number
2768518|NCT00750308|Primary|Insulin Sensitivity|As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm|three weeks|Those who completed protocol|||(mU/L)-1x(min)-1xL||Standard Error|Mean
2768519|NCT00750308|Primary|Beta Cell Function|Beta cell function as measured during a frequently sampled IV glucose tolerance test|3 hours||||microU/mM||Standard Error|Mean
2768520|NCT00750282|Secondary|Standard Uptake Value Ratios for Florbetaben Signal|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)|90-110 min post injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||ratio||Standard Deviation|Mean
2768521|NCT00750282|Secondary|Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)|The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.|45-60 min, 90-110 min, 110-130 min|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||Kappa coefficient|||Number
2768522|NCT00750282|Secondary|Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment|PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed|45 - 60 min and 110 - 130 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||percentage of subjects||95% Confidence Interval|Number
2768523|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.|"Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores 2 or 3) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score 1) which was considered a match for specificity.~The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia.~Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media."|90 - 110 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||percentage of subjects||95% Confidence Interval|Number
2768524|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth|"Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis.~Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used.~Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of 1 (without beta-amyloid plaque load) or 2 (with minor beta-amyloid plaque load) was considered normal and a BAPL score of 3 (with significant beta-amyloid plaque load) was considered abnormal.~Using algorithm B (Average), a brain scan of a subject with a BAPL score of 1 was considered normal and a brain scan with a BAPL score of 2 or 3 was considered abnormal. Algorithm B was used in Part B and in the final"|90 - 110 min after investigational medical product (IMP) injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)|||percentage of subjects||95% Confidence Interval|Number
2768525|NCT00750269|Secondary|Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0|Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.|From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment who were observed more than 1 year after start of SBRT|||percentage of participants||95% Confidence Interval|Number
2768526|NCT00750269|Secondary|Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0|Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.|From start of SBRT until 1 year.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2768527|NCT00750269|Secondary|Distant Metastases|Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2768528|NCT00750269|Secondary|Nodal Progression|Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of patients||95% Confidence Interval|Number
2768609|NCT00749580|Primary|Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen|Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.|at 24weeks for each patient||||participants|||Number
2768529|NCT00750269|Secondary|Local Progression|Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2768530|NCT00750269|Secondary|Overall Survival|An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2768531|NCT00750269|Secondary|Progression-free Survival|Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2768532|NCT00750269|Primary|(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)|Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.|From start of SBRT to 2 years.|All eligible patients who started study treatment|||percentage of participants||90% Confidence Interval|Number
2768533|NCT00750269|Primary|(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity <= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).|From start of SBRT to 1 year|All eligible patients who started study treatment|||Gy/FX|||Number
2768534|NCT00750204|Primary|Amount of Sedatives Used||48 hours|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
2768535|NCT00750191|Other Pre-specified|Opioid Usage|Patient reported Opioid usage (converted to morphine equivalents)|6 months||||mg||Standard Deviation|Mean
2768536|NCT00750191|Secondary|Disability|Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)|6 months||||units on a scale||Standard Deviation|Mean
2768537|NCT00750191|Secondary|Pain|Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)|6 months||||units on a scale||Standard Deviation|Mean
2768538|NCT00750191|Primary|Physical Function|"Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component.~Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome)."|6 months||||units on a scale||Standard Deviation|Mean
2768539|NCT00750165|Secondary|Arousal Index (AI)|The Arousal Index is a calculation of the frequency of awakenings per hour of sleep. The higher the number, the more awakenings per hour.|1 Night||||events per hour||Full Range|Mean
2768540|NCT00750165|Secondary|Respiratory Disturbance Index (RDI)|Similar to AHI, the RDI is a calculation of the total number of respiratory disturbances in sleep. The calculation includes apneas and hypopneas, but also includes respiratory effort related arousals.|1 Night||||events per hour||Full Range|Mean
2768541|NCT00750165|Secondary|Percent of Time With Less Than 90% Oxygen Saturation|Oxygen saturation is a measurement of the amount of oxygen present in the blood. An oxygen saturation of less than 90% is considered low, resulting in hypoxemia. Normal blood oxygen level is considered between 95-100%.|1 Night||||percentage of total sleep time||Full Range|Mean
2768542|NCT00750165|Primary|Apnea Hypopnea Index (AHI)|The Apnea Hypopnea Index (AHI) measure of severity of Obstructive Sleep Apnea (OSA). It is a calculation of the number of apnea events and the number of hypopnea events divided by the total sleep time. Mild OSA is characterized between 5-15 events per hour. Moderate OSA is characterized as 15-30 events per hour. Severe OSA is characterized as greater than 30 events per hour.|1 night||||events per hour||Full Range|Mean
2768648|NCT00749190|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA|Baseline and 12 weeks|FAS (CLOCF)|||mU/L||Standard Error|Mean
2768543|NCT00750152|Secondary|Mycological Cure and Treatment Effectiveness|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.|Week 4 (two weeks post-treatment)|This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.|||percentage of subjects|||Number
2768544|NCT00750152|Primary|Percentage of Subjects|Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.|Week 4 post-baseline|The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment.|||percentage of subjects with complete cur|||Number
2768545|NCT00750139|Secondary|Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.|Week 6|This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment.|||percentage of Subjects|||Number
2768546|NCT00750139|Primary|Percentage of Subjects With Complete Cure at Week 6.|"The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.~The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.~Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale."|Week 6|This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment.|||percentage of subjects with complete cur|||Number
2768547|NCT00750061|Secondary|Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain|Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)|6 months|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2768548|NCT00750061|Primary|Changes of Neurological Scores for Baseline|Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.|6 months|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2768549|NCT00749996|Secondary|To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).|"The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).~The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability."|12 Months||||patient's score||Standard Deviation|Mean
2768550|NCT00749996|Primary|To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).|The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.|6 Months||||units on a scale||Standard Deviation|Mean
2768551|NCT00749957|Secondary|Participants With Changes in Best Corrected Visual Acuity|Increase in BCVA of 7 or more letters at Year 2 visit compared to average baseline value|2 years||||participants|||Number
2768552|NCT00749957|Secondary|Participants With Changes in Visual Fields|Improvement in the central 30 degree visual field, measured by static perimetry, at one or more time points after treatment, that was greater than the limit of agreement for baseline values .|2 years||||participants|||Number
2768553|NCT00749957|Primary|Number of Participants Experiencing Ocular or Non-ocular Adverse Events||2 years||||participants|||Number
2768554|NCT00749944|Secondary|Change From Baseline in the Number of Cigarettes Smoked Per Day||Baseline (Week 0) to Week 2|FAS; (n)=number of subjects with at least 1 dose of study drug and an observation for a given day.|||cigarettes smoked per day||Standard Deviation|Mean
2768555|NCT00749944|Secondary|Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (during treatment) in the previous 7 days and who did not have carbon monoxide of more than 10 parts per million for that observation (if measured).|Week 5 to Week 13|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768556|NCT00749944|Secondary|Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory, which was used to collect the information of cigarette or other nicotine use during the study) and who did not have carbon monoxide of more than 10 parts per million at any time from Week 9 to Week 12|Week 9 to Week 12|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768558|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score|The BIS-11 is designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Total score ranged from 30 (less impulsive) to 120 (more impulsive). Participants exceeding the threshold had a BIS-11 total score more than or equal to 70 out of 120. BIS-11 total scores of more than or equal to 70 could reflect clinically important and potentially pathological impulsivity.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768559|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Suicidality total score ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency). No threshold criterion was determined for OAS-m Suicidality total score.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|The number of participants above the threshold for the OAS-m Suicidality total score was not analyzed as the majority of observations were recorded as 0.|||participants|||Number
2768560|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Irritability total score ranged from 0 (no irritability) to 10 (extreme irritability). Participants exceeding the threshold had an OAS-m Irritability total score of more than or equal to 2 out of 10. OAS-m Irritability total scores of more than or equal to 2 reflect clinically important irritability.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768561|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Aggression total score ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. Participants exceeding the threshold had an OAS-m Aggression total score of more than or equal to 3 out of any number with no upper limit depending on the frequency of agressive behaviour in a week. OAS-m Aggression total scores of more than or equal to 3 reflect clinically important aggression.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768562|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms. Total scores ranged from 0 (not affected) to 56 (very severely affected). Participants exceeding the threshold had a HAM-A total score of more than or equal to 14 out of 56. HAM-A total scores of more than or equal to 14 may reflect clinically noteworthy levels of anxiety.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768563|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms. Total score ranged from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Participants exceeding the threshold had a MADRS total score of more than 14 out of 60. MADRS total scores exceeding 14 may represent clinically notable effective symptomatology.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively. Statistical analyses were not performed for Period AB due to the small number of participants exceeding the threshold.|||participants|||Number
2768564|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score|POMS total mood disturbance (TMD) summary results were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). Participants exceeding the threshold had an increase from baseline of 1 standard deviation of the TMD baseline T-score plus 1 or more.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
2768565|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale|The MNWS increased appetite subscale contains 1 item (increased appetite) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no increased appetite) to 4 (extreme increased appetite).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768566|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale|The MNWS restlessness subscale contains 1 item (restlessness) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no restlessness) to 4 (extreme restlessness).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768567|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale|The MNWS urge to smoke subscale contains 1 item (urge to smoke) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no urge to smoke) to 4 (extreme urge to smoke).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768568|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale|The MNWS insomnia domain subscale contains 2 items (difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average of the 2 items and ranged from 0 (no insomnia) to 4 (extreme insomnia).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768569|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale|The MNWS negative affect domain subscale contains 4 items (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average from all 4 items and ranged from 0 (no negative affect) to 4 (extreme negative affect).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768570|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score|The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Total scores were the average score for all 9 items and ranged from 0 (no withdrawal symptoms) to 4 (extreme withdrawal symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768571|NCT00749944|Primary|Change From Baseline in the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score|The BIS-11 is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Possible responses to each item were: 1=rarely/never, 2=occasionally, 3=often, and 4=almost always/always. Scores of Items 1, 7, 8, 9, 10, 12, 13, 15, 20, 29 and 30 were reversed when calculating the total score. Total score ranged from 30 (less impulsive) to 120 (more impulsive).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768572|NCT00749944|Primary|Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score|The SDAS contains 11 items with 5 possible responses: 0=not present, 1=doubtful or very mild, 2=mild to moderate, 3=severe, and 4=extremely severe. The SDAS was collected 3 times a day during the inpatient abstinence period (BC). Total scores ranged from 0 (not present) to 44 (extremely severe).|Baseline B (Week 2) to Week 4 (Period BC)|No change from baseline analysis was performed on the SDAS total score as the majority of observations were recorded as 0.|||scores on a scale||Standard Error|Least Squares Mean
2768573|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Suicidality total score was calculated by summing the items Q7 to 7b. Scores for Q7 ranged from 0 (none) to 6 (very extreme) and scores for Q7a to 7b ranged from 0 (none) to 5 (extreme). Total scores ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|No change from baseline analysis was performed on the OAS-m Suicidality total score as the majority of observations were recorded as 0.|||scores on a scale||Standard Error|Least Squares Mean
2768574|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Irritability total score was calculated by summing the items in Q5 to 6. Scores for each question ranged from 0 (not at all) to 5 (extreme). Total scores ranged from 0 (no irritability) to 10 (extreme irritability).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768575|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768576|NCT00749944|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms and is a 14-item questionnaire. Each item was scored from 0 (not present) to 4 (very severe) and a lower score indicated less affected. Total scores ranged from 0 (not affected) to 56 (very severely affected).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768577|NCT00749944|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms and is a 10-item checklist. Each item was rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768578|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale|POMS Confusion subscale data were responses to 7 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Efficient. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768579|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale|POMS Fatigue subscale data were responses to 7 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768580|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale|POMS Vigor subscale data were responses to 8 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768581|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale|POMS Anger-Hostility subscale data were responses to 12 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768582|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale|POMS Depression-Dejection subscale data responses to 15 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768583|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale|POMS Tension-Anxiety subscale data were responses to 9 items regarding 'How you feel right now?' on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Relaxed. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768584|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)|POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on 'How you feel right now?' (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|Full analysis set (FAS): All randomized subjects with at least 1 dose of study drug and at least 1 post-baseline neuropsychiatric evaluation or Minnesota Nicotine Withdrawal Scale (MNWS) obtained; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2768586|NCT00749931|Primary|The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.|Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively|two weeks after surgery|"The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen (PSS – Positive specimen subjects)"|||percentage of participants analyzed|||Number
2768587|NCT00749879|Primary|Terminal Elimination Half-life (T1/2) of Proellex|Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.|Up to 72 hours post dose|All 12 subjects received each treatment|||Hours||Standard Deviation|Mean
2768588|NCT00749879|Primary|AUC0-infinity of Proellex|Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration|Up to 72 hours post dose|All 12 subjects received each treatment|||ng/mL*hour||Standard Deviation|Mean
2768589|NCT00749879|Primary|Tmax of Proellex|Time to maximum plasma occurrence of Cmax|Up to 72 hours post dose|All 12 subjects received each treatment|||Hours||Standard Deviation|Mean
2768590|NCT00749879|Primary|AUC0-last of Proellex|Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.|Up to 72 hours post dose|All 12 subjects received each treatment|||ng/mL*hour||Standard Deviation|Mean
2768591|NCT00749879|Primary|Cmax of Proellex|Maximum observed concentration of Proellex|Up to 72 hours post-dose|12 subjects received all 5 treatments|||ng/mL||Standard Deviation|Mean
2768592|NCT00749775|Secondary|Number of Participants That Responded to Selara Treatment.|Number of participants among the efficacy analysis population that responded to Selara treatment.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||participants|||Number
2768593|NCT00749775|Secondary|Change in Diastolic Blood Pressure Over Time.|The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||mmHg||Standard Deviation|Mean
2768594|NCT00749775|Secondary|Change in Systolic Blood Pressure Over Time.|The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||mmHg||Standard Deviation|Mean
2768595|NCT00749775|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|12 weeks|No statistical analysis provided for the frequency of serious treatment related adverse events.|||participants|||Number
2768596|NCT00749775|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.|12 weeks|No statistical analysis provided for the frequency of Treatment Related adverse events.|||participants|||Number
2768597|NCT00749684|Primary|Relapse Free Survival Time|Median time to recurrence according to Kaplan Maier evaluation|Throughout 12 months of treatment and 24 months of follow-up||||months||Full Range|Median
2768598|NCT00749684|Primary|Number of Participants With Disease Recurrence|Number of participants with disease recurrence was being measured.|Throughout 12 months of treatment and 24 months of follow-up|138 participants with malignant melanoma, 88 male participants and 50 female participants were evaluated.|||participants|||Number
2768599|NCT00749671|Secondary|Patient Recall of Defibrillation Testing|The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.|30 minutes||||percentage of patients with DFT recall|||Number
2768600|NCT00749671|Primary|Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes|"Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness:~OAAS score 5—awake and responds readily to name spoken in normal tone.~OAAS score 4—lethargic responses to name in normal tone.~OAAS score 3—responds only after name is called loudly and/or repeatedly.~OAAS score 2—responds only after name called loudly and mild shaking.~OAAS score 1—does not respond when name is called loudly and mild shaking or prodding.~OAAS score 0—does not respond to noxious stimulation."|30 minutes||||units on a scale||95% Confidence Interval|Mean
2768601|NCT00749606|Secondary|International Physical Activity Questionnaire|Measure of physical activity is calculated as in mets/week|baseline, 6 months, 1 and 2 years||||mets per week||Standard Error|Mean
2768602|NCT00749606|Secondary|SF-12 Physical Summary Score|The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).|baseline, 6 months, 1 and 2 years||||units on a scale||Standard Error|Mean
2768603|NCT00749606|Secondary|Health Behaviors (Diet, Physical Activity)|National Cancer Institute Fat screener|baseline, 6 months, 1 and 2 years||||percentage of daily calories from fat||Standard Error|Mean
2768604|NCT00749606|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|baseline, 1, 2, 3 years||||mg/dL||Standard Deviation|Mean
2768605|NCT00749606|Secondary|Fasting Lipid Panel|LDL-cholesterol (mg/dL)|baseline, 1, 2, 3 years|Note: LDL-cholesterol measurements were not available for 13 participants in the Individual Call arm and 6 participants in the Conference Call arm|||mg/dL||Standard Deviation|Mean
2768606|NCT00749606|Secondary|Blood Pressure|Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)|baseline, 1, 2, 3 years||||mmHg||Standard Deviation|Mean
2768610|NCT00749515|Secondary|Number of Participants With Polymorphisms in Genes Known to be, or Potentially Involved, in Deferasirox Disposition|Polymorphisms in genes known to be, or potentially involved, in deferasirox disposition: UGT1a1 (including the Gilbert syndrome promoter polymorphism, (TA)nTAA),UGT1a3, BRCP/ABCG2, MRP2/ABCC2. These genes were chosen because deferasirox is primarily eliminated by glucuronidation and subsequent biliary excretion.|3 months||||Participants|||Count of Participants
2768611|NCT00749515|Primary|Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg|Clearance/bioavailability (CL/F)|0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.||||liter/hour||Standard Deviation|Mean
2768612|NCT00749515|Primary|Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg|Volume of distribution/bioavailability (Vd/F), adjusted per kilogram body weight|0, 1, 2, 4, 6, 8, 12, and 24 hours post dose||||liter/kilogram||Standard Deviation|Mean
2768613|NCT00749515|Primary|Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg|Volume of distribution/bioavailability (Vd/F)|0, 1, 2, 4, 6, 8, 12, and 24 hours post dose||||liter||Standard Deviation|Mean
2768614|NCT00749515|Primary|Half-Life of Deferasirox|"All patients received the same interventions of deferoxamine challenge, deferasirox dose with pharmacokinetic monitoring. Then we compared responses between patients who were known to be slow responders to deferasirox and those who were known to be rapid responders (chelated well).~Deferoxamine: After a 3-day washout period from all chelation, all patients have a 12 hour infusion of 50mg/kg of deferoxamine with urine collection and pre and post blood sampling to assess iron and Total Iron Binding Capacity (TIBC) by atomic absorption."|0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.||||hour||Standard Deviation|Mean
2768615|NCT00749515|Primary|Area Under the Curve of Deferasirox After a Dose of 35 mg/kg|Area Under the Curve (AUC) 0 to 24 hours post dose|0, 1, 2, 4, 6, 8, 12, and 24 hours post dose||||micromole/liter*hour||Standard Deviation|Mean
2768616|NCT00749476|Primary|Number of Participants Reporting Efficacy|Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.|4 months|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||Participants|||Number
2768617|NCT00749463|Secondary|Point Prevalence Smoking Abstinence (PPSA)|Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.|24 Weeks||||Participants|||Number
2768618|NCT00749463|Primary|Smoking Abstinence|Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day|24 Weeks||||Participants|||Number
2768619|NCT00749463|Secondary|Smoking Consumption Per Week|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)|24 Weeks from last visit:||||Cigarettes||Standard Deviation|Mean
2768620|NCT00749463|Secondary|Smoking Consumption Per Day|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)|24 Weeks from last visit:||||Cigarettes||Standard Deviation|Mean
2768621|NCT00749463|Secondary|Carbon Monoxide (CO)-Verified Smoking Reduction|Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)|Baseline to Week 24||||Percentage of Participants||Standard Deviation|Mean
2768622|NCT00749463|Primary|Self-Reported Smoking Reduction|Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day|24 Weeks||||Percentage of Participants||Standard Deviation|Mean
2768623|NCT00749463|Primary|Treatment-Related Adverse Events|Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher|24 Weeks|Safety Analysis Set (ITT)|||Percentage of Participants|||Number
2768624|NCT00749398|Secondary|Number of Participants With Satisfactory Health Status|"Participant's opinion on his/her health status, as assessed by the following question: Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Participants|||Number
2768625|NCT00749398|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768626|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Participant|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768627|NCT00749398|Secondary|Static PGA Score as Assessed by the Participant|Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768628|NCT00749398|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768629|NCT00749398|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768630|NCT00749398|Secondary|Percent Body Surface Area (BSA) Involved With Psoriasis||Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)|Per protocol analysis.|||Percent BSA Involved with Psoriasis||Standard Deviation|Mean
2768631|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Investigator|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768632|NCT00749398|Primary|Dynamic Photographic PGA Score as Assessed by Two Dermatologists|The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768633|NCT00749398|Secondary|Static PGA Score as Assessed by the Investigator|Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768634|NCT00749398|Primary|Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists|Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
2768635|NCT00749268|Secondary|Hernia Recurrence||Discharge, 1 Month, 6 Month, 1 year||||participants|||Number
2768636|NCT00749268|Secondary|Quality of Life|"Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.~The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Pre-op, Month 1, Month 6, 1 year|Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.|||units on a scale||Standard Deviation|Mean
2768637|NCT00749268|Primary|Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events||One year||||participants|||Number
2768638|NCT00749268|Primary|Postoperative Pain|"Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.~Scale is 0 - 10 with 0 being no pain and 10 being worst pain imaginable."|Discharge, Month 1, Month 6, Month 12|1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.|||units on a scale||Standard Deviation|Mean
2768639|NCT00749203|Secondary|Hopkins Verbal Learning Test (HVLT)|Repeatable test of memory acquisition and delayed recall of words. It is a three-trial list learning and free recall task comprising 12 words, 4 words from each of three semantic categories. Total Recall score range is 0 to 36.|20 to 40 minutes after infusion|data not collected||||||
2768640|NCT00749203|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered questionnaire measuring depressive symptoms. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Mean difference between baseline and 2 weeks.|24 hours after first infusion||||units on a scale||Standard Deviation|Mean
2768641|NCT00749203|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|Self-report questionnaire measuring depressive symptoms. Each item is rated 0 (no depression) to 3 (severe depression). The total score ranges from 0-27.|24 hours after first infusion||||units on a scale||Standard Deviation|Mean
2768642|NCT00749203|Secondary|Clinician-Administered PTSD Scale (CAPS)|Clinician-administered structured interview measuring PTSD symptoms. frequency score - scale 0 = none of the time to 4 = most or all of the time intensity score - scale 0 = none to 4 = extreme To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. 30 questions scale, with total score ranging from 0 to 240.|7 days after first infusion|Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.|||units on a scale||Standard Deviation|Mean
2768643|NCT00749203|Primary|Impact of Event Scale - Revised (IES-R)|"A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)"|7 days after first infusion|Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.|||units on a scale||Standard Deviation|Mean
2774163|NCT00711009|Secondary|Mean Change From Baseline in Platelet Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
2768649|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)|||percentage of participants|||Number
2768650|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)|||percentage of participants|||Number
2768651|NCT00749190|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.|||percentage of HbA1c||Standard Error|Mean
2768652|NCT00749190|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|FAS using modified LOCF imputation method|||mg/dL||Standard Error|Mean
2768653|NCT00749190|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment|"Change from baseline in HbA1c after 12 weeks of treatment.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).|||percentage of HbA1c||Standard Error|Mean
2768654|NCT00749125|Primary|Activations in Different Cortical Regions Caused by Emotionally Evocative Task|MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group.|baseline and week 8|23 patients with major depression were matched with 18 demographically similar healthy controls. Depressed subjects were treated with Lexapro 10 mg/day, initiated immediately following the first fMRI scan.|||Voxels||Standard Deviation|Mean
2768655|NCT00749073|Primary|Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.|The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Six months|All available treated patients with six month follow-up.|||units on a scale||95% Confidence Interval|Mean
2768656|NCT00749073|Primary|Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire|Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.|Baseline and Month 6|All treated patients having six month follow-up were included.|||units on a scale||Standard Deviation|Mean
2768657|NCT00749073|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.|||units on a scale||Standard Deviation|Mean
2768658|NCT00748982|Secondary|QTcF Interval|Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula|Up to 24 hours following start of IV dosing.||||ms||95% Confidence Interval|Mean
2768659|NCT00748982|Secondary|Area Under Curve (AUC) ( µmol*h/L) of AZD1305|To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.||||µmol*h/L||Full Range|Mean
2768660|NCT00748982|Secondary|Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group|To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.|From randomisation to last study visit (mean infusion time 1.6 hours)||||Participants|||Number
2774164|NCT00711009|Secondary|Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^12/liter||Standard Deviation|Mean
2768661|NCT00748982|Primary|Left Ventricular Ejection Fraction (LVEF), Change From Baseline|To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out||||Percent change||95% Confidence Interval|Mean
2768662|NCT00748969|Secondary|Safety: Number Drug Related SAEs||1 months|Study stopped early due to inability to enroll participants.|||Participants|||Count of Participants
2768663|NCT00748969|Primary|Change in Growth Velocity From Baseline to End of Study Year 1.||12 months|"Zero participants analyzed in the No growth hormone treatment group due to subject withdrew from study as soon as informed they were assigned the no treatment group."|||cm/yr|||Number
2768664|NCT00748956|Secondary|Profile of Mood States (POMS)|measure in 2 hours post intranasal administration and on the next morning|on study day 2|data not collected||||||
2768665|NCT00748956|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|measure in 2 hours post intranasal administration|on study day 2|data not collected||||||
2768666|NCT00748956|Secondary|Post-sleep Questionnaire|measure in the morning|on study day 2|data not collected||||||
2768667|NCT00748956|Secondary|Appetite Scale|measure in 2 hours post intranasal administration|on study day 2|data not collected||||||
2768668|NCT00748956|Secondary|Systematic Assessment of Treatment-Emergent Effects (SAFTEE)|Number of participants with serious adverse events|on study day 2||||Participants|||Count of Participants
2768669|NCT00748956|Primary|Levels of NPY in CSF|Levels of Neuropeptide Y in the cerebrospinal fluid|on study day 2||||pg/mL||Standard Deviation|Mean
2768670|NCT00748865|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,|once upon instillation||||Units on a scale||Standard Deviation|Median
2768671|NCT00748826|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~No~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participant|||Number
2768672|NCT00748826|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the In-vitro TB test (cellular blood test, i.e. gamma interferon release assays) per clinical testing as the first screening test was presented in three categories:~Yes~No~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
2768673|NCT00748826|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (Multiple puncture Tuberculin skin test) per clinical testing as the first screening test was presented in three categories:~Yes~No~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
2768674|NCT00748826|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (Tuberculin sensitivity skin test by intradermal injection) per clinical testing as the first screening test was presented in~three categories:~Yes~No~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
2768675|NCT00748709|Secondary|Number of Patients With Diarrhea or Rash|Number of Patients with Diarrhea or Rash|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
2768676|NCT00748709|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.|Day 15||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2768677|NCT00748709|Primary|Percentage of Participants With Objective Response (OR)|OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.|||percentage of patients|||Number
2768678|NCT00748709|Secondary|Maximum CTCAE Grade|Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
2768679|NCT00748709|Secondary|Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation|Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
2768708|NCT00748566|Secondary|Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mmol/L||Standard Deviation|Mean
2768680|NCT00748709|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for PFS.||||||
2768681|NCT00748709|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for duration of OR.||||||
2768682|NCT00748709|Secondary|Time to Objective Response (OR)|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|Trial terminated early, therefore no data summaries produced for time to OR.||||||
2768683|NCT00748709|Secondary|Percentage of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|TS.|||percentage of patients|||Number
2768684|NCT00748657|Secondary|Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0|Adverse Events at least possibly related to study agent.|Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
2768685|NCT00748657|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||Months||95% Confidence Interval|Median
2768686|NCT00748657|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
2768687|NCT00748657|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients|||percentage of patients||90% Confidence Interval|Number
2768688|NCT00748579|Secondary|Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output|Measure the effect of CK-1824752 on invasively measured hemodynamics, including filling pressure and cardiac output|1 day|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2768689|NCT00748579|Secondary|Effects of CK-1827452 on Systolic Ejection Time|Measure the effect of CK-1824752 on systolic ejection time|1 day|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2768690|NCT00748579|Secondary|Effects of CK-1827452 on Pressure-volume Relationships|Measure the effect of CK-1824752 on pressure-volume relationships|1 day|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2768691|NCT00748579|Secondary|Effects of CK-1827452 on Myocardial Oxygen Consumption|Measure the effect of CK-1824752 on myocardial oxygen consumption|1 day|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2768692|NCT00748579|Secondary|Effects of CK-1827452 on Ventricular Performance|Measure the effect of CK-1824752 on ventricular performance|1 day|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2768693|NCT00748579|Primary|Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.|Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.|1 day|Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.||||||
2768694|NCT00748566|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|"C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior(3)(Yes on preparatory acts or behavior), suicidal ideation(4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(Yes on Has subject engaged in non-suicidal self-injurious behavior)."|Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2768695|NCT00748566|Secondary|Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2768706|NCT00748566|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52|Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||kg/m^2||Standard Deviation|Mean
2768696|NCT00748566|Secondary|Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2768697|NCT00748566|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52|SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2768698|NCT00748566|Secondary|Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52|DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2768699|NCT00748566|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale Score|CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.|Endpoint (premature discontinuation or Week 52)|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2768700|NCT00748566|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52|CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2768701|NCT00748566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52|Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2768702|NCT00748566|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).|Baseline, Week 4, 12, 28, 52|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.|||milliseconds||Standard Deviation|Mean
2768703|NCT00748566|Secondary|Change From Baseline in the Physical Activity Index Score at Week 28 and 52|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2768704|NCT00748566|Secondary|Change From Baseline in Insulin Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||international unit per liter (IU/L)||Standard Deviation|Mean
2768705|NCT00748566|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of total hemoglobin||Standard Deviation|Mean
2768709|NCT00748566|Secondary|Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||percent of 10-year CHD risk||Standard Deviation|Mean
2768710|NCT00748566|Secondary|Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mg/dL||Standard Deviation|Mean
2768711|NCT00748566|Secondary|Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52|Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mg/dL||Standard Deviation|Mean
2768712|NCT00748566|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52|BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mmHg||Standard Deviation|Mean
2768713|NCT00748566|Secondary|Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52|Waist circumference data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||cm||Standard Deviation|Mean
2768714|NCT00748566|Secondary|Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of participants||95% Confidence Interval|Number
2768715|NCT00748566|Secondary|Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||participants|||Number
2768716|NCT00748566|Secondary|Percentage of Participants With Metabolic Syndrome (MS)|According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of participants||95% Confidence Interval|Number
2768717|NCT00748566|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||risk factors||Standard Deviation|Mean
2768718|NCT00748566|Primary|Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)|MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.|Endpoint (premature discontinuation or Week 52)|Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants||95% Confidence Interval|Number
2768719|NCT00748553|Secondary|Progression-free Survival|Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.|2 years|Data were not collected.||||||
2768720|NCT00748553|Secondary|Number of Participants With ER+ Status|Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).|2 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. Thirteen patients were evaluated for ER+ status.|||participants were ER+|||Number
2768721|NCT00748553|Primary|Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria|"Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized.~For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1.5 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity.|||percentage of participants||95% Confidence Interval|Number
2768722|NCT00748553|Primary|Phase I: Percentage of Participants Responding to Treatment|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.|6 months|16 patients were evaluable for toxicity. 13 were evaluable for response per RECIST v1.|||percent of participants with response||95% Confidence Interval|Number
2768723|NCT00748540|Secondary|Residual Hearing in Patients Implanted With Vibrant Soundbridge|Unaided hearing thresholds measured at the 10 month interval compared to the preoperative interval in order to assess any changes|10 months post initial activation||||Participants|||Count of Participants
2768724|NCT00748540|Secondary|Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.|Signal to Noise Ratio for sentences at the preoperative interval compared to the 6 month interval.|6 months post initial activation|3 subjects did not completed this testing due to limitations of the equipment used.|||Signal to Noise Ratio||Standard Deviation|Mean
2768725|NCT00748540|Secondary|Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.|Auditory thresholds in the soundfield at the preoperative interval compared to the 6 month postoperative interval.|6 months post initial activation||||Participants|||Count of Participants
2768726|NCT00748540|Primary|Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge|Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.|6 months post initial activation||||percentage of words correct||Standard Deviation|Mean
2768727|NCT00748410|Secondary|Amount of Medicine in Blood|Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|At 1, 2.25, 4, 8 hour on Day 1 and 7|All subjects population.|||nanogram per hour (ng/hr)|||Number
2768728|NCT00748410|Secondary|Changes From Baseline to After Treatment in Faecal Calprotectin Levels|Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.|Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7|All subjects population.|||milligram per litre (mg/L)|||Number
2768729|NCT00748410|Secondary|Vital Signs Assessment- Heart Rate|Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|Day 1 and 7|All subjects population. Only those participants with data available at the specified time points were analyzed.|||beats per minute (bpm)|||Number
2768730|NCT00748410|Secondary|Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|Day 1 and 7|All subject population. Only those participants with data available at the specified time points were analyzed.|||millimeter of mercury (mmHg)|||Number
2768731|NCT00748410|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up (7 to 10 days after last dose)|All subject population.|||Participants|||Count of Participants
2768732|NCT00748410|Primary|Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)|Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.|Baseline (Day -1) and Day 1 and 7|The ‘All Subjects population’ was defined as all participants who received at least one dose of study medication. Only those participants with data available at the specified time points were analyzed.|||Score on scale|||Number
2768734|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 3 years after implants have been loaded|Population includes subjects who completed 36 month visit.|||Percentage of implants|Participants||Number
2768735|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 2 years after implants have been loaded|Population includes subjects who completed 24 month visit.|||Percentage of implants|Participants||Number
2768736|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 1 year after implants have been loaded|Population includes subjects who completed 12 month visit.|||Percentage of implants|Participants||Number
2768737|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 6 months after implants have been loaded|Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).|||Percentage of implants|Participants||Number
2768738|NCT00748189|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From start of treatment up to 30 days after last treatment|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Gram per liter||Standard Deviation|Mean
2768739|NCT00748189|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 28.9 months)|Safety Population|||Participants|||Number
2768740|NCT00748189|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy, up to approximately 111 months.|Safety Population|||Participants|||Number
2768741|NCT00748189|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented by treatment cycle. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy, up to approximately 111 months.|Safety Population|||Participants|||Number
2768742|NCT00748189|Secondary|Number of Participants With AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy, up to approximately 111 months.|Safety Population|||Participants|||Number
2768743|NCT00748189|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy, up to approximately 111 months.|Safety Population|||Participants|||Number
2769421|NCT00741936|Secondary|Blood Creatinine Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||μmol/L||Standard Deviation|Mean
2768744|NCT00748189|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL)|HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQC30), Chronic Lymphocytic Leukemia module (EORTC QLQ-CLL16), EuorQoL-Five Dimension (EQ-5D), and HCQ. Period (P)1 (Day 85, Day 169, Day 253) and P2 (scheduled follow-up (FU) and withdrawal visits) analysis were considered. Baseline (BL) for P1 was defined as score from screening visit and BL for P2 was defined as the last on-treatment score. The 2 principal QoL outcomes were pre-specified as the Global Health scale (GHS/QOL) of the EORTC QLQ-C30 and fatigue scale of the EORTC QLQ-CLL16. For EORTC QLQ-C30,GHS/Qol, the possible scale range was 0-100 (with 100 being 'best') and a positive difference from BL is indicative of better functioning (range -100 to +100). For the EORTC QLQ-CLL16 fatigue scale, the possible scale range was 0-100 (with 0 being 'best') and a negative difference from BL represents an improvement in fatigue (range -100 to +100).|Baseline, Cycle 4 day 1, cycle 7 day 1, 1 month follow-up, 6 month follow-up, 12 month follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
2768745|NCT00748189|Secondary|Dose-normalized AUC(0-6) and AUC(0-inf) of Chlorambucil and Dose-normalized AUC(0-6) of Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and over 6 hours (AUC[0-6]) of chlorambucil and AUC(0-6) of PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.|||Hours*nanogram/milliliter/milligram||Standard Deviation|Geometric Mean
2768746|NCT00748189|Secondary|Dose-normalized Cmax of Chlorambucil and Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The maximum observed concentration (Cmax) of chlorambucil and PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.|||nanograms per milliliter per milligram||Standard Deviation|Geometric Mean
2768747|NCT00748189|Secondary|Plasma Half Life (t1/2) of Ofatumumab|The terminal half-life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original concentration. Blood samples were collected to assess the plasma half-life of ofatumumab. Blood samples were collected from participants who received ofatumumab plus chlorambucil pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2768748|NCT00748189|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Blood samples were collected from participants who received ofatumumab plus chlorambucil at predose and 0.5 hour after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."|||Liters||Geometric Coefficient of Variation|Geometric Mean
2768749|NCT00748189|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval [AUC(0-tau)] is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the ofatumumab plasma concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of ofatumumab. For estimation of AUC(0-tau), blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hous after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."|||µg x hours/mL||Geometric Coefficient of Variation|Geometric Mean
2768750|NCT00748189|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population.|||Milliliter/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2768810|NCT00747565|Primary|Mean Binocular Distance Corrected Near Visual Acuity in Snellen|Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.|One year|Binocular subjects at one year available for testing for both studies combined.|||Mean Snellen Line (with ETDRS line SD)||Standard Deviation|Mean
2768751|NCT00748189|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of treatment.|Cycle 1 Day 1,Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1|Pharmacokinetic (PK) Population: all participants for whom a pharmacokinetic sample was obtained and analyzed.|||Micrograms/Milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2768752|NCT00748189|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result|Serum samples for analysis of HAHA were collected at Baseline (Screening), Cycle 4 Day 1 (after 3 months of treatment), and at 1 month and 6 months post last dose of ofatumumab. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive and further evaluated in the titration test to obtain a titer of HAHA.|Baseline, Cycle 4 Day 1, 1 Month Follow-up, and 6 Month Follow-up|Safety population: all participants who received at least 1 dose of a study drug. Only participants with post-ofatumumab HAHA Results are included.|||Participants|||Number
2768753|NCT00748189|Secondary|Number of Participants With Improvement in Constitutional Symptoms (CS)|Assessment for the presence of the following symptoms were performed at Screening, Day 1 of each treatment cycle and at every Follow-up visit: night sweats (without signs of infection); unexplained, unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of greater than 38 degrees celsius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue. The best response refers to overall best response in terms of CR, CRi, PR or nPR. Data are presented for constitutional response= yes and no.|Baseline, Cycle 3 Day 1, and 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2768754|NCT00748189|Secondary|Number of Participants With Improvement in ECOG Performance Status of 0 or 1|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. Participants with an ECOG performance status of 0 or 1 are shown..|Baseline, Cycle 3 Day 1, 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2768755|NCT00748189|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From randomization up to about 49 months|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
2768756|NCT00748189|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From randomization up to about 49 months|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
2768757|NCT00748189|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From randomization up to about 43 months|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.|||Months||95% Confidence Interval|Median
2768804|NCT00747643|Secondary|A Measure of the Subjective Expected Value of a Cigarette|The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).|3 weeks per participant|Per Protocol|||Dollars||Standard Error|Mean
2768805|NCT00747643|Primary|Cue-provoked Cravings|"Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale How strong was your craving to smoke a cigarette?"|3 weeks per participant|Per Protocol|||Scores on a scale||Standard Error|Mean
2768758|NCT00748189|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (CR, CRi, nPR, or PR). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders. Only responders (CR, CRi, PR, nPR) were included in the analysis.|From randomization uo to about 27 months|ITT population. Time to response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Months||95% Confidence Interval|Median
2768759|NCT00748189|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the total IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization up to about 111 months|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
2768760|NCT00748189|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD)|MRD was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization until the 259th PFS event occurred (Median follow-up approximately 28.9 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
2768761|NCT00748189|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization until the 259th PFS event occurred, up to about 49 months|ITT population. Only those participants with data available at the indicated time points were analyzed. OR was according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.|||Participants|||Number
2768762|NCT00748189|Primary|Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From randomization to the date of first documented disease progression or death due to any cause, whichever occured first, reported between day of first patient randomized up to about 49 months|Intent-to-Treat (ITT) Population: all par. randomized to study treatment regardless of whether or not they received treatment. PFS was assessed by a blinded independent review committee according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines.|||Months||95% Confidence Interval|Median
2768763|NCT00748098|Secondary|"Number of Participants Who Self-reported Very Satisfied or Satisfied With the Investigational Product at Week 4/10 Using LOCF"|"Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study. The participant responses ranged from 1 (Very satisfied) to 7 (Very dissatisfied). A satisfied response was scored a 2."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
2768764|NCT00748098|Secondary|"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"|"The CGI-I scale allows the investigator to rate the participant's global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (Very much improved) or 2 (Much improved) are considered to be responders."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
2768806|NCT00747643|Secondary|Smoking Topography - Number of Puffs on a Cigarette|# Puffs = total number of puffs taken at Assessment Session.|3 weeks per participant|Per Protocol|||Puffs on a Cigarette||Standard Error|Mean
2768811|NCT00747565|Primary|Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.|"Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject."|One year|First eye results from subjects at one year in both the original study and the expansion study combined.|||Participants (First Eyes only)|||Number
2768765|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF|The CGI-S scale allows the investigator to rate the severity of participants' illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
2768766|NCT00748098|Secondary|Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF|"Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant's subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: Helped me sleep, Helped me fall asleep faster, Helped me sleep longer, and Helped me get a better night's sleep."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
2768767|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
2768768|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||number of PLMs per hour||Standard Error|Least Squares Mean
2768769|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.|Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768770|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes/hour||Standard Error|Least Squares Mean
2768771|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768772|NCT00748098|Secondary|Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||participants|||Number
2768826|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768773|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||hours||Standard Error|Least Squares Mean
2768774|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF|The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||awakenings||Standard Error|Least Squares Mean
2768775|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.|Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||scores on a scale||Standard Error|Least Squares Mean
2768776|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF|Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||scores on a scale||Standard Error|Least Squares Mean
2768777|NCT00748098|Secondary|Number of PLMAI Responders at Week 4/10 Using LOCF|PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||participants|||Number
2768778|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||number of PLMs/total hours of sleep||Standard Error|Least Squares Mean
2768779|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10|Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
2768780|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF|In REM sleep, a participant's breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768781|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10|Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
2768782|NCT00748098|Secondary|Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF|Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768783|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10|Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
2768784|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF|In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768785|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF|Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
2768786|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF|"Stage N1 is considered light sleep, during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as somnolence or drowsy sleep. Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768787|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF|"The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: In the past week, how severe was your sleep disturbance due to your RLS symptoms?. The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
2768807|NCT00747643|Primary|Tonic Craving Score (QSU) Based on Self Reports|Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.|3 weeks per participant|Per Protocol|||Scores on a scale||Standard Error|Mean
2768788|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF|The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
2768789|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||limb movements per hour||Standard Error|Least Squares Mean
2768790|NCT00748098|Primary|Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)|"PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a sleep study that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
2768791|NCT00748085|Secondary|Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.||1 year|no analysis conducted. Study terminated for business reasons||||||
2768792|NCT00748085|Primary|Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.||1 year|no analysis conducted-study terminated for business reasons||||||
2768793|NCT00748072|Primary|The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.||Immediately post-biopsy and 24 hours post-biopsy.||||participants|||Number
2768794|NCT00747916|Secondary|To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.||1 year|zero participants analyzed due to early termination of study||||||
2768795|NCT00747916|Primary|To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.||1 year|zero participants analyzed due to early termination of study||||||
2768796|NCT00747812|Primary|Number of Days With 4 or More Hours of Headache||12 Weeks||||Days||Standard Deviation|Mean
2768797|NCT00747812|Primary|Number of Hours of Headache||12 weeks||||Hours||Standard Deviation|Mean
2768798|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After two weeks||||percentage of patients|||Number
2768799|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After one week|Eligibility according to in/ex criteria and compliance with study requirements|||percentage of patients|||Number
2768800|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)|After two weeks||||percentage of patients|||Number
2768801|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups."|After two weeks||||percentage of patients|||Number
2768802|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups"|After one week|Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements|||percentage of patients|||Number
2768803|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)|After one week|The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.|||percentage of patients|||Number
2768812|NCT00747552|Secondary|Median Bladder Pressure for All Measurements|Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.|||mmHg||Inter-Quartile Range|Median
2768813|NCT00747552|Primary|Intra-abdominal Pressure(IAP) Measurements in NICU Patients.|Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.|||IAP measurements|||Number
2768814|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768815|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768816|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768817|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768818|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768819|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
2768820|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
2768821|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
2768822|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
2768823|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
2768824|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768825|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768883|NCT00746889|Other Pre-specified|Change in WOMAC Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 12 weeks|These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.|||units on a scale||Standard Deviation|Mean
2768827|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768828|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
2768829|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1h, 1h30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
2768830|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
2768831|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
2768832|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
2768833|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
2768834|NCT00747474|Primary|Number of Participants With Adverse Events|Number of participants with AEs that occurred during treatment and follow-up period (30 days after last treatment). Drug-related AEs and SAEs were followed until resolved or stabilized. AEs were classified by the investigator according to severity graded using CTCAE version 3.0 and relationship to study drug. The severity scale is: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to AE|an average of 6 months|Patients received at least one dose of Lipotecan|||participants|||Number
2768835|NCT00747474|Secondary|Anti-tumor Activity|Patients were evaluated by tumor assessment using RECIST guidelines. Possible evaluations include: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the size of target lesions. Progressive Disease (PD): at least a 20% increase in the size of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From start of treatment assessed every 2 cycles up to 2.5 years|Patients received at least one dose of Lipotecan.|||participants|||Number
2768836|NCT00747474|Primary|Maximum Tolerated Dose (MTD) of Lipotecan|MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.|First treatment to toxicity up to 42 days|Patients received at least one dose of Lipotecan.|||mg/m^2|||Number
2768837|NCT00747461|Secondary|Treatment Durability|need for additional treatments within specified period|12 months|study terminated-no subjects analyzed.||||||
2768838|NCT00747461|Primary|Improvement in Luminal Patency Following Cryospray Treatment||30 days|study terminated by Sponsor-data not analyzed||||||
2768839|NCT00747435|Secondary|Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.|Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.|12 months post initial activation|Only 59 subjects completed the HDSS at preop and 12 month post activation.|||Participants|||Count of Participants
2768840|NCT00747435|Secondary|Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.|A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.|12 months post initial activation|Only 59 subjects completed the APHAB at preop and 12 months post activation.|||percentage of scoring change (APHAB)||Standard Deviation|Mean
2768841|NCT00747435|Secondary|Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.|CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.|12 months post initial activation||||percentage of words correct (CNC)||Standard Deviation|Mean
2768842|NCT00747435|Secondary|Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.|12 months initial activation|One subject lost residual hearing immediately after surgery and was unable to use EAS. The subject was testing in cochlear implant alone condition.|||percentage of words correct (CUNY)||Standard Deviation|Mean
2768843|NCT00747435|Primary|Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.|12 months post initial activation|One subject lost residual hearing immediately following surgery and was unable to use EAS. This subject was tested with the cochlear implant alone and is not included in this analysis.|||percentage of words correct (CUNY)||Standard Deviation|Least Squares Mean
2768844|NCT00747344|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline to Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Scores on a scale||Standard Deviation|Mean
2768845|NCT00747344|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Participants|||Number
2768846|NCT00747344|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12|PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).|Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Participants|||Number
2768847|NCT00747227|Secondary|"Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent."|"Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit."|One Year|Two subjects in the ZV9003 group did not complete the one year questionnaire.|||participants|||Number
2768848|NCT00747227|Primary|Uncorrected Distance Visual Acuity|Snellen Equivalent of 20/40 or better at one year|One Year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.|||participants|||Number
2768849|NCT00747227|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|4-6 months|Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.|||log contrast||90% Confidence Interval|Mean
2768850|NCT00747227|Primary|Best Corrected Distance Visual Acuity|Snellen Equivalent visual acuity of 20/40 or better|One year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.|||participants|||Number
2768851|NCT00747214|Secondary|Change in Fatigue (MAF Scale) Score From Baseline to Day 42|"The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).~Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5~Sum items #1, 2, and 3~Average items #4 through 14~Add results from above Steps 1 through 3 to obtain a single score~A score was not be assigned to items #4 through 14 if a respondent indicated they did not engage any activity for reasons other than fatigue. If respondent selected no fatigue on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index."|Baseline and Day 42||||units on a scale||Standard Deviation|Mean
2768852|NCT00747214|Secondary|Change in DAS28 Score From Baseline to Day 42|To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.|Baseline and Day 42||||units on a scale||Standard Deviation|Mean
2768853|NCT00747214|Secondary|Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)|The percentage of subjects in each group that achieved an ACR 20 response on Day 42|Day 42||||percentage of participants|||Number
2768854|NCT00747214|Primary|Change in CRP From Baseline to Day 42|The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.|Baseline and Day 42||||percentage change from baseline||Standard Deviation|Mean
2768855|NCT00747149|Secondary|Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy||6 and 12 Weeks|||||||
2768856|NCT00747149|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12||6 and 12 Weeks|||||||
2768857|NCT00747149|Secondary|Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio||6 and 12 Weeks|||||||
2768858|NCT00747149|Secondary|Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment|Proportion of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC) ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment|6 and 12 Weeks|||||||
2768859|NCT00747149|Primary|Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy|The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100|12 Weeks||||Percentage||95% Confidence Interval|Mean
2768860|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
2768861|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
2768862|NCT00747006|Secondary|Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
2768863|NCT00747006|Secondary|Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
2768864|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||mg/dL||Full Range|Mean
2768865|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||mg/dL||Full Range|Mean
2768866|NCT00747006|Primary|Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||mg/dL||Full Range|Mean
2768867|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||mg/dL||Full Range|Mean
2768868|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
2768869|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
2768870|NCT00747006|Primary|Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
2768871|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
2768872|NCT00746954|Primary|Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)||Overnight polysomnogram over 3 separate nights|Comparisons among Drugs (not Arms)|||APNEA-HYPOPNEA/HR by drug or placebo||Standard Deviation|Mean
2768884|NCT00746889|Primary|Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 4 weeks|This population was defined as patients who completed the 4 week follow up assessment as per protocol.|||units on a scale||Standard Deviation|Mean
2768873|NCT00746941|Secondary|Participants Who Died Within 6 Months|The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.|Day 1 up to 6 months|"Safety population: All participants who enrolled in the study and were dosed, and who have at least 1 post-baseline safety assessment.~The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen."|||participants|||Number
2768874|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||log10 mm^3||Standard Deviation|Mean
2768875|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||log10 mm^3||Standard Deviation|Mean
2768876|NCT00746941|Secondary|Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||participants|||Number
2768877|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS)|"Participants rate their neurological function on a scale of 100 mm line, where the 0 end of the scale indicates poor neurological function and 100 indicates excellent neurological function. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
2768878|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT)|"The SDMT is a simple substitution task. The test gives participants 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0 (worst outcome) to 110 (best outcome).~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. SDMT was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
2768879|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score|"The KPS Index classifies participants' functional impairment. KPS can be used to compare effectiveness of different therapies and to assess the prognosis in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the KPS score, the worse the survival for most serious illnesses. The KPS index is subdivided into 3 categories: incapacitated (0 to 40), self-care (50 to 70), and normal activity (80 to 100).~Negative change from baseline scores indicate improved prognosis."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
2768880|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death) was calculated. Negative change scores indicate improvement.|Day 0 (baseline), Week 4 and 8|"Participants with values at the time frames being measured. EDSS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
2768881|NCT00746941|Primary|Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 8 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 8|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 8 were available."|||log10 copies/mL||Standard Deviation|Mean
2768882|NCT00746941|Primary|Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 4|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 4 were available."|||log10 copies/mL||Standard Deviation|Mean
2768885|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.|"At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever."|24 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.|||cm||Standard Deviation|Mean
2768886|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.|"At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever."|6 hours postoperative from mid-urethral sling placement|Intention to treat|||cm||Standard Deviation|Mean
2768887|NCT00746863|Secondary|Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.|Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.|From after surgery to discharge from hospital.||||participants w/sucessful voiding trial|||Number
2768888|NCT00746863|Secondary|In-hospital Medication Amounts|Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.|From surgery until discharge, average||||number of pills||Standard Deviation|Mean
2768889|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.|"At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever."|2 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.|||cm||Standard Deviation|Mean
2768890|NCT00746798|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.||Day 0 up to Day 14 post-vaccination|Safety assessments were on the Safety, intend-to-treat Population.|||Participants|||Number
2768891|NCT00746798|Primary|Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|"Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.~Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10."|Day 0 and Day 28 post-vaccination|Serum antibody levels and seroconversion were assessed in the per-protocol population.|||Participants|||Number
2768892|NCT00746798|Secondary|Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.|Day 2 up to Day 14 post-vaccination|Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.|||Participants|||Number
2768893|NCT00746798|Primary|Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine|Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.|Day 0 and Day 28 post-vaccination|Serum antibody levels were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2768894|NCT00746785|Primary|Drinks Per Drinking Day|"Drinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the Time Line Follow Back method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time."|up to 36 weeks||||Drinks per drinking day||Standard Deviation|Mean
2768895|NCT00746733|Primary|T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
2768896|NCT00746733|Primary|AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
2768897|NCT00746733|Primary|Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
2768898|NCT00746733|Primary|Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||ng/ml||Standard Deviation|Mean
2768899|NCT00746733|Primary|T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
2768900|NCT00746733|Primary|AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC||0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
2768901|NCT00746733|Primary|Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
2768902|NCT00746733|Primary|Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||ng/ml||Standard Deviation|Mean
2768903|NCT00746733|Secondary|Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Pre-dose, 2 and 8 hours after dosing|Safety population|||msec||Standard Deviation|Mean
2768906|NCT00746733|Primary|Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
2768907|NCT00746733|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
2768908|NCT00746733|Primary|Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
2768909|NCT00746733|Secondary|Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2768910|NCT00746733|Secondary|DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population|||units on a scale||Standard Deviation|Mean
2768911|NCT00746733|Secondary|DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population|||units on a scale||Standard Deviation|Mean
2768912|NCT00746733|Secondary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.|||units on a scale||Standard Deviation|Mean
2768913|NCT00746733|Primary|Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.|||ng/ml||Standard Deviation|Mean
2768914|NCT00746694|Primary|Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE|The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.|Participants will do a single visit, but cases will be collected during a period of 12 months.||||Participants|||Number
2768915|NCT00746694|Primary|Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)|"Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.~Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it."|Participants will do a single visit, but cases will be collected during a period of 12 months.||||Participants|||Number
2768916|NCT00746668|Primary|Sentence Reading|To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).|Pre-training, 6 weeks, 12 weeks, 18 weeks|Intent to Treat|||Words per Minute (wpm)||Standard Deviation|Mean
2768917|NCT00746590|Secondary|Changes in Laboratory Measurements||Baseline and every 3 weeks until progression|||||||
2768918|NCT00746590|Secondary|Adverse Events||Until progression|||||||
2768919|NCT00746590|Secondary|Changes in Alpha Fetoprotein||Baseline, every 3 weeks until progression|||||||
2768920|NCT00746590|Secondary|Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour||Every 6 weeks until progression|||||||
2768921|NCT00746590|Secondary|Time to Tumour Progression||Every 3 weeks until progression|||||||
2768922|NCT00746590|Secondary|Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease||Approximately 12 weeks or more after first treatment with Prolarix|||||||
2768923|NCT00746590|Primary|Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST||every 6 weeks until progression|Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.|||participants||Standard Deviation|Mean
2769422|NCT00741936|Secondary|Blood Urea Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||mmol/L||Standard Deviation|Mean
2768924|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings - Phase II|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.|6 weeks|All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958|||percentage of inappropriate recordings|Recording|95% Confidence Interval|Number
2768925|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings - Phase I|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).|||percentage of inappropriate recordings|Recordings|95% Confidence Interval|Number
2768926|NCT00746564|Other Pre-specified|Interpretability of Automatically Triggered/Symptom Driven Recordings|The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.|||percentage of interpretable recordings|Recordings|95% Confidence Interval|Number
2768927|NCT00746564|Other Pre-specified|Interpretability of Weekly Subject Activator Recordings|The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.|||percentage of interpretable recordings|Clinical Recordings|95% Confidence Interval|Number
2768928|NCT00746564|Primary|Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers|The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)|||percentage of recordings|Clinical Recordings|95% Confidence Interval|Number
2768929|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).|||percentage of recordings|Clinical recordings|95% Confidence Interval|Number
2768930|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings at Rest|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.|||percentage of recordings|Clinical Recordings|95% Confidence Interval|Number
2768931|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings|||percentage of recordings|Clinical Recordings|95% Confidence Interval|Number
2768932|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).|||percentage of recordings|Clinical Recordings|95% Confidence Interval|Number
2768933|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings at Rest|The sensitivity was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).|||percentage of recordings|Clinical recordings|95% Confidence Interval|Number
2768934|NCT00746551|Secondary|Haemoglobin Level||3 weeks after intervention||||g/dL||Standard Deviation|Mean
2768935|NCT00746551|Primary|Serum Ferritin Level||3 weeks after intervention||||µg/dL||Standard Deviation|Mean
2768936|NCT00746512|Secondary|Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])|"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:~DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.~Where SQR is square root and ln is natural log.~The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission."|Baseline and Day 14||||score on scale||Standard Deviation|Mean
2768937|NCT00746512|Primary|Synovial Blood Flow|Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.|Baseline and Day 14||||pixel count||Standard Deviation|Mean
2774739|NCT00708071|Secondary|Resolution of Edema as Assessed by Investigators.|Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
2768938|NCT00746421|Secondary|Brief Assessment of Cognition for Affective Disorders (BAC-A)|This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115).|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.|||units on a scale (composite t-score)||Standard Deviation|Mean
2768939|NCT00746421|Primary|The Continuous Performance Test-Identical Pairs Version|The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.|||units on a scale||Standard Deviation|Mean
2768940|NCT00746395|Secondary|Small Bowel Transit|Small bowel transit time|Duration of the test - 8 hours|Patients without transit to cecum were excluded|||Minutes||Standard Error|Mean
2768941|NCT00746395|Primary|Complete Small Bowel Transit|Percent of subjects with capsule passage through small bowel|8 hours|Placebo 95%, lubiprostone 75%|||percentage of subjects with passage|||Number
2768942|NCT00746356|Primary|Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.|||Volts||Standard Deviation|Mean
2768943|NCT00746356|Primary|Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.|||Volts||Standard Deviation|Mean
2768944|NCT00746356|Primary|Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.|||Volts||Standard Deviation|Mean
2768945|NCT00746356|Primary|Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.|3 months post implant|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.|||Volts||Standard Deviation|Mean
2768946|NCT00746356|Primary|Percentage of Participants Free of System-related Complications at 3-months Post Implant||3 months post implant||||Percentage of Participants|||Number
2768947|NCT00746330|Secondary|Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in urine was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for urine was 0.0174 nmol/L expressed as free base. The amounts of unchanged formoterol excreted in urine from 0 to 3 hours (Ae0-3) and from 0 to 12 hours post-dose (Ae0-12) were calculated from the formoterol concentrations in urine and the urine volumes using non-compartmental methods.|0 to 3 hrs and 0-12 hrs|The pharmacokinetic population which was modified by the exclusion of dosing periods where formoterol was present at a concentration in excess of 5% of the Cmax.Five subjects were excluded due to various reasons.|||nmol||90% Confidence Interval|Least Squares Mean
2768948|NCT00746330|Secondary|Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in plasma was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for plasma was 1.45 pmol/L. No non-compartmental PK analysis was performed.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Because of the dosing periods where formoterol was present at concentrations greater than 5% of the Cmax data for 4 subjects was excluded. A dosing error resulted in the exclusion of 1 subject and 1 subject had all data excluded from PK evaluation due to the plasma drug concentrations in conflict with the recorded randomization.|||pmol/L||Standard Deviation|Mean
2768949|NCT00746330|Secondary|Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS/ERS standards|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
2768950|NCT00746330|Secondary|Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FVC is the volume (liters) of air that can forcibly be blown out after full inspiration. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS / ERS standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
2768951|NCT00746330|Secondary|Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FEV1 is the maximum amount of air expired in one second. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the (ATS / ERS) standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
2768952|NCT00746330|Primary|The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment|For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose|From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
2768953|NCT00746252|Primary|Weight Gain|Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.|These measurements are done biweekly from baseline up until 12 weeks||||pounds||Standard Deviation|Mean
2768954|NCT00746239|Secondary|Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.||10 weeks|||||||
2768955|NCT00746239|Primary|Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.||10 weeks|||||||
2768956|NCT00746187|Primary|Marginal Bone Level Changes|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.|3 years after implant placement (baseline)|Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.|||millimeter|Participants|Standard Deviation|Mean
2768957|NCT00746122|Secondary|Hospital Costs to Enable Cost-effectiveness Evaluation|Hospital costs to enable cost-effectiveness evaluation in Pounds (£)|3 years||||GBP (£)||Standard Deviation|Mean
2768958|NCT00746122|Secondary|Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation|"QALYs are a product of length of life and quality of life, since both of these are important to patients. Therefore, it is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.~QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life, and freedom from pain and mental disturbance."|3-years from randomisation||||life-years||Standard Deviation|Mean
2768959|NCT00746122|Primary|Mortality|Mortality, at 3 pre-specified time points|30 days, 1-year and 3-years from randomisation||||Participants|||Count of Participants
2768960|NCT00746096|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks||||units on a scale||Standard Deviation|Mean
2768961|NCT00746096|Primary|Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|"Five patients in the IKH-01 group were excluded from efficacy analysis due to no available data for 3 patients and 2-4 administration days for 2 patients.~One patient in the placebo group was also excluded from efficacy analysis."|||units on a scale||Standard Deviation|Mean
2768962|NCT00746018|Primary|To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.||conclusion of the study|Data were not collected||||||
2768963|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Acceptance Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
2768964|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Awareness Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
2768965|NCT00745940|Secondary|Symptom Checklist-90 Revised (Depression Subscale)|"The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from Not at All to Extremely with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms."|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
2768966|NCT00745940|Primary|Beck Depression Inventory - II|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders—Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
2768967|NCT00745940|Secondary|Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27."|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
2768968|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Participants|||Number
2768969|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 2|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Participants|||Number
2768970|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 1|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
2768971|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Participants|||Number
2768972|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 2|Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Participants|||Number
2768973|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 1|Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
2768974|NCT00745901|Primary|Overall Number of Days of Total Blood Loss|cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 to 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
2768975|NCT00745901|Primary|Number of Days of Total Blood Loss - Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 3 (Day 57 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
2768976|NCT00745901|Primary|Number of Days of Total Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 2 (day 29 to Day 56)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
2768977|NCT00745901|Primary|Number of Days of Total Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 (Day 8 to Day 28)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
2768978|NCT00745901|Primary|Overall Number of Days of Scheduled Blood Loss|summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 to Cycle 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
2768979|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
2768980|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
2768981|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
2768982|NCT00745901|Primary|Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes|Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
2768983|NCT00745901|Primary|Overall Number of Days of Unscheduled Blood Loss|cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
2768984|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 3|Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
2768985|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
2768986|NCT00745901|Secondary|Patient Satisfaction - Overall|patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.|Cycle 1 to Cycle 3|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
2768987|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
2768988|NCT00745875|Secondary|Progression-free Survival|Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method|Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation||||Days||Full Range|Median
2768989|NCT00745875|Primary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)|Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).||||Days||Full Range|Median
2768990|NCT00745849|Primary|Total Nasal Symptom Scores|(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm|Last two weeks of each treatment arm|Each study participant was in both arms of the study since this was a crossover study|||score on a scale||Full Range|Mean
2768991|NCT00745823|Secondary|Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|||||||
2768992|NCT00745823|Secondary|Number of Participants With One or More Adverse Events at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|||||||
2768993|NCT00745823|Secondary|Mean Change From Baseline to Week 96 in CD4 Cell Count|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Baseline and Week 96|The Week 96 data analysis was not performed.||||||
2768994|NCT00745823|Secondary|Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.||||||
2768995|NCT00745823|Secondary|Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.||||||
2768996|NCT00745823|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count||Baseline and Week 48|Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.|||cells/mm^3||95% Confidence Interval|Mean
2768997|NCT00745823|Primary|Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.|||Participants|||Number
2768998|NCT00745823|Primary|Number of Participants With One or More Adverse Events at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.|||Participants|||Number
2768999|NCT00745823|Secondary|Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks||48 weeks|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.|||Participants|||Number
2769000|NCT00745823|Primary|Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks||Week 48|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.|||Participants|||Number
2769001|NCT00745615|Secondary|Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score|EDSS (developed by John F. Kurtzke) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and other functions). Each functional system score and an overall score ranges from 0 to 10, where 0 = Normal; 1-1.5 = No disability, but some abnormal neurological signs; 2-2.5 = Minimal disability; 3-4.5 = Moderate disability, affecting daily activities, but can still walk; 5-8 = More severe disability, impairing daily activities and requiring assistance with walking; 8.5-9.5 = Very severe disability, restricting to bed; 10 = Death due to MS. A lower score indicated less disability.|At the end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, ‘Overall number of participants analyzed’=participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2769065|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for Visual Learning at Week 1.|||arcsine proportion correct||Standard Error|Least Squares Mean
2769002|NCT00745615|Secondary|Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans|Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions.|At the end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, ‘Overall number of participants analyzed’=participants evaluable for this outcome measure.|||lesions||Standard Deviation|Mean
2769003|NCT00745615|Secondary|Double-Blind Period: Volume of T2 Lesions|Volume of T2 lesion was assessed by magnetic MRI.|At the end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, ‘Overall number of participants analyzed’=participants evaluable for this outcome measure.|||cubic millimeters (mm^3)||Standard Deviation|Mean
2769004|NCT00745615|Secondary|Double-Blind Period: Number of New T2 Lesions|Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions.|At the end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, ‘Overall number of participants analyzed’=participants evaluable for this outcome measure.|||lesions||Standard Deviation|Mean
2769005|NCT00745615|Secondary|Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions. T1-weighted scan was taken after administration of gadolinium-gadopentetic acid (Gd-DTPA).|At the end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, ‘Overall number of participants analyzed’=participants evaluable for this outcome measure.|||lesions||Standard Deviation|Mean
2769006|NCT00745615|Secondary|Double-Blind Period: Percentage of Relapse-Free Participants|Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the EDSS; or one grade in the score of 2 or more of the 7 FS (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.|||percentage of participants|||Number
2769007|NCT00745615|Secondary|Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses|Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the Expanded disability status scale (EDSS); or one grade in the score of 2 or more of the 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).|Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.|||relapses||Standard Deviation|Mean
2769008|NCT00745615|Primary|Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.|Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)|Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL.|||Participants|||Count of Participants
2769009|NCT00745615|Primary|Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.|Baseline (Week 0) to Week 36|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.|||Participants|||Count of Participants
2769010|NCT00745615|Primary|Open-label Extension Period: Number of Participants With AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)|Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL.|||Participants|||Count of Participants
2769011|NCT00745615|Primary|Double-Blind Extension Period: Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|Baseline (Week 0) to Week 36|ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.|||Participants|||Count of Participants
2769012|NCT00745498|Secondary|Postoperative Resolution of Neovascularization||6 months|||||||
2769013|NCT00745498|Secondary|Visual Outcome|Best-corrected visual acuity (BCVA) at postoperative 6 months|6 months||||logMAR||Standard Deviation|Mean
2769014|NCT00745498|Secondary|Initial Time of Vitreous Clearing (ITVC)|The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.|6 months||||days||Standard Deviation|Mean
2769015|NCT00745498|Primary|Recurrent VH Incidence (Early and Late)|"Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. Early recurrent VH was VH occurring <= 4 weeks and late recurrent VH was VH occurring >4 weeks after surgery."|6 months|With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis.|||Percentage of participants|||Number
2769016|NCT00745420|Secondary|Change From Baseline to 1 Year in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to 1 year post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|1 year post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
2769017|NCT00745420|Secondary|Change From Baseline to 1 Year in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to 1 year post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|1 year post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
2769018|NCT00745420|Secondary|Change From Baseline to Day 180 in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 180 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|180 days post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
2769019|NCT00745420|Secondary|Change From Baseline to Day 180 in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 180 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|180 days post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
2769020|NCT00745420|Secondary|Change From Baseline to Day 100 in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 100 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|100 days post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
2769021|NCT00745420|Secondary|Change From Baseline to Day 100 in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 100 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|100 days post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
2769022|NCT00745420|Secondary|Percentage of Participants With Posterior Reversible Encephalopathy Syndrome (PRES)||1 year||||percentage of participants||95% Confidence Interval|Number
2769023|NCT00745420|Secondary|Number of Participants With Chronic GVHD by Severity|Chronic GVHD severity is defined per NIH 2005 Consensus Criteria.|1 year post-transplant||||Participants|||Count of Participants
2769024|NCT00745420|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is defined per NIH 2005 Consensus Criteria.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
2769025|NCT00745420|Secondary|Percentage of Participants With Acute Graft-vs-Host-Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|100 days||||percentage of participants||95% Confidence Interval|Number
2769026|NCT00745420|Secondary|Graft Rejection|Primary graft rejection is defined as the presence of less than 20% donor cells as assessed by peripheral blood or bone marrow chimerism assays on or after Day 42. Secondary graft rejection is defined as the presence of less than 20% donor derived hematopoietic cells in peripheral blood or bone marrow that occurs after prior evidence of 20% or greater donor cells.|1 year||||Participants|||Count of Participants
2769027|NCT00745420|Secondary|Neutrophil and Platelet Recovery|Time to neutrophil recovery is defined as the time of the first of three measurements on consecutive days where the patient has an absolute neutrophil count of >= 500/uL following conditioning regimen induced nadir. Time to platelet recovery is defined as the time of the first of three measurements on consecutive days where the patient has achieved a platelet count > 50,000/uL and is platelet transfusion independent for a minimum of seven days following conditioning regimen induced nadir.|Up to 100 days||||days||Full Range|Median
2769028|NCT00745420|Secondary|Percentage of Participants With Overall Survival (OS)|OS is defined as the percentage of participants that have not died.|2 years||||percentage of participants||95% Confidence Interval|Number
2769029|NCT00745420|Primary|Percentage of Participants With Event-Free Survival (EFS)|EFS is defined as percentage of participants that have not had an event. Primary or secondary graft rejection, disease recurrence, or death will count as events for this endpoint.|2 years||||percentage of participants||95% Confidence Interval|Number
2769030|NCT00745368|Primary|Female Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose||||ratio||Inter-Quartile Range|Median
2769031|NCT00745368|Primary|Male Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose||||ratio||Inter-Quartile Range|Median
2769032|NCT00745368|Primary|Female Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose||||hours||Inter-Quartile Range|Median
2769033|NCT00745368|Primary|Male Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose||||hours||Inter-Quartile Range|Median
2769034|NCT00745368|Primary|Female Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
2769035|NCT00745368|Primary|Male Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
2769036|NCT00745368|Primary|Raltegravir Female Genital Tract Concentration||8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
2769037|NCT00745368|Primary|Raltegravir Male Genital Tract Concentration||8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
2769038|NCT00745290|Secondary|Number of Participants With Adverse Events Through 96 Hours and Serious Adverse Events Through 30 Days||through 30 days|||||||
2769039|NCT00745290|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|"The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"|through 72 hours post surgery|Note: 245 subjects were randomized and received study drug and were included in the analyses.|||Units on a scale*hours||Standard Deviation|Mean
2769040|NCT00745251|Secondary|Percent Change in Weight From Baseline to Week 28||baseline to week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
2769041|NCT00745251|Primary|Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.|AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep|between baseline and Week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||events/hour||Standard Error|Least Squares Mean
2769042|NCT00745121|Primary|Marginal Bone Level Alterations|Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at time of loading of the permanent restoration (baseline).|Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.|"In group A, 11 subjects (38 implants) completed the 5-year follow-up visit. In group B, 26 subjects (79 implants) completed the 5-year follow-up visit.~Three radiographs were not possible to evaluate, giving an overall number of 37 subjects (114 implants) as basis for the analysis of Marginal Bone Level Change."|||millimeter|Implants|Standard Deviation|Mean
2769043|NCT00745095|Secondary|Polyp Detection|The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.|Time of Study||||Number of polyps detected (numerical)||Standard Deviation|Mean
2769044|NCT00745095|Primary|Quality of Bowel Preparation|The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.|1-2 days following intervention||||units on a scale||Standard Deviation|Mean
2769045|NCT00745030|Secondary|Study Terminated Due to Low Subject Recruitment and Enrollment.|Low subject recruitment and enrollment||||||||
2769046|NCT00745030|Secondary|Changes in The Montreal Cognitive Assessment Scale (MoCA)||12 weeks|||||||
2769047|NCT00745030|Secondary|Changes in Mini-Mental State Exam (MMSE)||12 weeks|||||||
2769048|NCT00745030|Secondary|Changes in Physician Completed United Parkinson's Disease Rating Scale (UPDRS)||12 weeks|||||||
2769049|NCT00745030|Secondary|Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)||12 weeks|||||||
2769050|NCT00745030|Secondary|Changes in Patient Completed The Fatigue Severity Scale (FSS)||12 weeks|||||||
2769051|NCT00745030|Secondary|Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)||12 weeks|||||||
2769052|NCT00745030|Secondary|Changes in Beck Depression Inventory (BDI)||12 weeks|||||||
2769053|NCT00745030|Secondary|Changes in Patient Completed Epworth Sleepiness Scale (ESS)||12 weeks|||||||
2769054|NCT00745030|Secondary|Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale||12 weeks|||||||
2769055|NCT00745030|Secondary|Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)||12 weeks|||||||
2769056|NCT00745030|Secondary|Changes in Clinician Global Impression Scale of Improvement (CGI-I)||10 weeks|||||||
2769057|NCT00745030|Secondary|Changes in Mean TST, LPS, WASO (Based on PSG)||8 weeks|||||||
2769058|NCT00745030|Secondary|Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study||8 weeks|||||||
2769059|NCT00745030|Primary|Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers|"Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers.~Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment."|12 weeks||||Participants|||Number
2769060|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Identification at Week 6.|||log10 millisecond||Standard Error|Least Squares Mean
2769061|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Identification at Week 3.|||log10 millisecond||Standard Error|Least Squares Mean
2769062|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Identification at Week 1.|||log10 millisecond||Standard Error|Least Squares Mean
2769063|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for Visual Learning at Week 6.|||arcsine proportion correct||Standard Error|Least Squares Mean
2769064|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for Visual Learning at Week 3.|||arcsine proportion correct||Standard Error|Least Squares Mean
2769066|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 6.|||arcsine proportion correct||Standard Error|Least Squares Mean
2769067|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 3.|||arcsine proportion correct||Standard Error|Least Squares Mean
2769068|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 1.|||arcsine proportion correct||Standard Error|Least Squares Mean
2769069|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 6|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 6.|||errors||Standard Error|Least Squares Mean
2769070|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 3|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 3.|||errors||Standard Error|Least Squares Mean
2769071|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 1|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 1.|||errors||Standard Error|Least Squares Mean
2769072|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Detection at Week 6.|||log10 millisecond||Standard Error|Least Squares Mean
2769073|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Detection at Week 3.|||log10 millisecond||Standard Error|Least Squares Mean
2769074|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Detection at Week 1.|||log10 millisecond||Standard Error|Least Squares Mean
2769075|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 6|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 6|FAS. N = number of participants with a NPI total score at Week 6.|||scores on scale||Standard Error|Least Squares Mean
2769076|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 3|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 3|FAS. N = number of participants with a NPI total score at Week 3.|||scores on scale||Standard Error|Least Squares Mean
2769077|NCT00744978|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 6|FAS; N = number of participants with a CGI-I score at Week 6.|||units on a scale||Standard Error|Least Squares Mean
2769127|NCT00744692|Secondary|To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant||2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late graft failure endpoint.|||participants|||Number
2769078|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 6|FAS. N = number of participants with ADAS-Cog 70 results at Week 6.|||units on scale||Standard Error|Least Squares Mean
2769079|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 3|FAS. N = number of participants with ADAS-Cog 70 results at Week 3.|||units on scale||Standard Error|Least Squares Mean
2769080|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 3|FAS; N = number of participants with ADAS-Cog 75 results at Week 3.|||units on scale||Standard Error|Least Squares Mean
2769081|NCT00744978|Primary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 6|Full analysis set (FAS): all participants who were randomized and took at least 1 dose of randomized study medication. N = number of participants with ADAS-Cog 75 results at Week 6.|||units on scale||Standard Error|Least Squares Mean
2769082|NCT00744965|Secondary|Need for Insulin Therapy||throughout pregnancy and delivery||||Participants|||Count of Participants
2769083|NCT00744965|Secondary|Chorioamnionitis|Maternal fever >=38.0°C|intrapartum||||Participants|||Count of Participants
2769084|NCT00744965|Secondary|3rd or 4th Degree Perineal Laceration||at delivery||||Participants|||Count of Participants
2769085|NCT00744965|Secondary|Need for Insulin Treatment||after delivery||||Participants|||Count of Participants
2769086|NCT00744965|Secondary|Shoulder Dystocia||at delivery||||Participants|||Count of Participants
2769087|NCT00744965|Secondary|Diagnosis of Pregnancy-induced Hypertension||until hospital discharge||||Participants|||Count of Participants
2769088|NCT00744965|Secondary|Rate of Cesarean Delivery||After delivery||||Participants|||Count of Participants
2769089|NCT00744965|Secondary|Neonatal Intensive Care Unit Admissions||Until hospital discharge||||Participants|||Count of Participants
2769090|NCT00744965|Secondary|Macrosomia|birth weight 4,000 g or greater|After delivery||||Participants|||Count of Participants
2769091|NCT00744965|Secondary|Number of Participants With Large for Gestational Age Infants|Birth weight exceeding the 90th percentile for the gestational age at delivery.|After delivery||||Participants|||Count of Participants
2769092|NCT00744965|Primary|Mean Fetal Weight at Birth||Immediately after delivery of fetus||||grams||Standard Deviation|Mean
2769093|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
2769094|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
2769095|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
2769096|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set.|||Participants|||Number
2769112|NCT00744874|Primary|Chronic Effectiveness|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.|6 months|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.|||participants|||Number
2769113|NCT00744874|Primary|Number of Participants With Successful Pulmonary Vein Isolation|Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.|6 months|Subjects that had successful pulmonary vein isolation.|||participants|||Number
2769097|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
2769098|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
2769099|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
2769100|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d'orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
2769101|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
2769114|NCT00744848|Secondary|Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30||through day 30|||||||
2769115|NCT00744848|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|"To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"|through 96 hours|Note: 204 randomized subjects received study drug and were included in the analyses.|||Units on a scale*hours||Standard Deviation|Mean
2769102|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
2769103|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set|||Participants|||Number
2769104|NCT00744939|Primary|Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d'orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set|||Participants|||Number
2769105|NCT00744874|Secondary|Total Fluoroscopy Time|Total time that flouroscopy was used during the ablation procedure.|Post Ablation Procedure||||minutes||Standard Deviation|Mean
2769106|NCT00744874|Secondary|Total Procedure Time|"Measurement of total procedure time defined as skin to skin and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)"|End of Procedure||||minutes||Standard Deviation|Mean
2769107|NCT00744874|Secondary|Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins|Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation|After Procedure||||minutes||Standard Deviation|Mean
2769108|NCT00744874|Secondary|The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline|The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score.|6 months||||units on a scale||Standard Deviation|Mean
2769109|NCT00744874|Secondary|Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months|Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).|6 Months||||units on a scale||Standard Deviation|Mean
2769110|NCT00744874|Primary|Chronic Safety|The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|7 day post procedure to 6 months|The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|||participants|||Number
2769111|NCT00744874|Primary|Acute Safety|The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.|7 days post procedure|The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device.|||participants|||Number
2769473|NCT00741104|Secondary|Adverse Events (AEs)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
2769116|NCT00744757|Secondary|Quality of Life Assessment|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.|Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2769117|NCT00744757|Secondary|Number of Events Which Led to Hospitalization|The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.|Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Events|||Number
2769118|NCT00744757|Secondary|Duration for Hospitalization|Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.|Cycle 1 up to Cycle 8, each cycle of 28 days.|ITT population was defined as all participants who had received at least one dose of treatment. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Days||Standard Deviation|Mean
2769119|NCT00744757|Secondary|Percentage of Participants With Transfusion Independency|Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.|8 weeks before first dose and 736 days of treatment|ITT population was defined as all participants who had received at least 1 dose of study medication.|||percentage of participants|||Number
2769120|NCT00744757|Secondary|Percentage of Participants With Transfusion Dependency|Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.|8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
2769121|NCT00744757|Secondary|Overall Survival|Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Months||Full Range|Median
2769122|NCT00744757|Secondary|Time to Acute Myeloid Leukemia (AML) Progression or Death|Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Months||Full Range|Median
2769123|NCT00744757|Secondary|Percentage of Participants With Cytogenetic Response|Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated at given time point.|||Percentage of participants|||Number
2769124|NCT00744757|Secondary|Percentage of Participants With Hematologic Treatment Response|Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here ‘N’ specifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluable for this outcome measure at given time point.|||Percentage of participants|||Number
2769125|NCT00744757|Primary|Percentage of Participants With Response|Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here ‘N’ specifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2769126|NCT00744692|Secondary|To Describe the Pace of Platelet Recovery|Platelet engraftment was defined as the first day of platelet counts more than 50,000/uL for 7 consecutive days without transfusions|180 days post transplant||||days||Full Range|Median
2769128|NCT00744692|Secondary|To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure||at least 2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late effects endpoint.|||percentage of patients|||Number
2769129|NCT00744692|Secondary|To Describe the Incidence of Grade 3-4 Organ Toxicity||2 years post transplant||||participants|||Number
2769130|NCT00744692|Secondary|To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV)|To describe incidence of acute Graft Versus Host Disease (GVHD) (II - IV) : measured by cumulative incidence analysis|100 days post transplant||||percentage of participants||95% Confidence Interval|Number
2769131|NCT00744692|Secondary|To Determine the Overall Survival at day180 Post-transplant|To determine the overall survival at day180 post-transplant: determined by Kaplan Meier survival analysis|180 days||||percentage of participants||95% Confidence Interval|Number
2769132|NCT00744692|Secondary|To Evaluate the Pace of Immune Reconstitution.|Immune reconstitution after RIC in UCBT was described. CD4 count is a standard measure of immune reconstitution and is described here. Additional data is available upon request.|1 year post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of Immune reconstitution endpoint. CD4 count is reported here.|||cells/uL||Full Range|Median
2769133|NCT00744692|Secondary|To Describe the Pace of Neutrophil Recovery|Neutrophil recovery was defined as the first day of an absolute neutrophil count (ANC) more than 500/uL for 3 consecutive days not secondary to granulocyte infusions|42 days post transplant||||days||Full Range|Median
2769134|NCT00744692|Primary|Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders.|Determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor cells at 180 days) following reduced intensity conditioning regimens in children < 21 years receiving cord blood transplant for non-malignant disorders.|180 days post transplant|Of the 22 patients enrolled, 18 patients were alive at 180 days, the time-point for primary end point|||% of participants|||Number
2769135|NCT00744653|Secondary|Safety and Toxicity||up to 1 year|per protocol|||adverse events|Participants||Number
2769136|NCT00744653|Secondary|Participants With Objective Response Evaluated With PET/CT|Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.|3, weeks, 8 weeks, and up to 6 months after treatment|per protocol|||participants|||Number
2769137|NCT00744653|Primary|Clinical Measure of Lesion Size.|Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size|up to one year|Based on Simons optimal design for phase II trials, 25 evaluable patients were to be included and treated.|||Participants|||Number
2769138|NCT00744627|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set.|||participants|||Number
2769139|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769140|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769141|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769142|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769143|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769144|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769145|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769146|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769147|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769148|NCT00744627|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression-Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769149|NCT00744627|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2769150|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769151|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2769152|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2 and 4|"Full analysis set where Baseline data were available. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769153|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769154|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1 and 4|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769155|NCT00744627|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2769156|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2769157|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2769158|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.|||percentage of participants|||Number
2769171|NCT00744497|Other Pre-specified|Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable|||Participants|||Number
2769159|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2769160|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2769161|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2769162|NCT00744627|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2769163|NCT00744523|Secondary|Access Site Adverse Events|Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.|Index Procedure through Hospital Discharge||||participants|||Number
2769164|NCT00744523|Secondary|Target Lesion Revascularization at 30 Days|Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.|Up to 30 days after the procedure was performed||||participants|||Number
2769165|NCT00744523|Secondary|Restenosis at 30 Days|Number of subjects with re-narrowing of the lesion at 30 days as defined as a >= 50% stenosis measured by duplex ultrasound scan.|Up to 30 days after the procedure was performed||||participants|||Number
2769166|NCT00744523|Secondary|Procedural Success|"Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization.~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure through hospital discharge||||participants|||Number
2769167|NCT00744523|Secondary|Technical Success|"Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis < 30% during the index procedure(as evaluated by the angiographic core laboratory).~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure|Roll-In participants were analysed on the number of roll-in cases performed. Pivotal subjects were analysed as Intention To Treat (ITT).|||participants|||Number
2769168|NCT00744523|Secondary|Device Success|Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.|The entire duration of the index procedure|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria who were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.|||participants|||Number
2769169|NCT00744523|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.|Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.|Up to 30 days after the procedure was performed|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.|||participants|||Number
2769170|NCT00744497|Other Pre-specified|Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study|BL=baseline; OS=on-study|At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated|All participants who were randomized to receive any treatment|||Participants|||Number
2769189|NCT00744380|Secondary|Sedation-related Adverse Effects||Duration of ICU stay, up to 24 weeks||||participants|||Number
2769172|NCT00744497|Other Pre-specified|Number of Participants by Maximal On-study Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable|||Participants|||Number
2769173|NCT00744497|Other Pre-specified|Number of Participants With Abnormal Results in Urinalysis|Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment.|||Participants|||Number
2769174|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0-10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0-6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment|||Participants|||Number
2769175|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology|Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment|||Participants|||Number
2769176|NCT00744497|Other Pre-specified|Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment|||Participants|||Number
2769177|NCT00744497|Other Pre-specified|Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment|||Participants|||Number
2769178|NCT00744497|Secondary|Percentage of Participants With a Reduction in Pain Intensity From Baseline|The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.|At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants with a baseline pain intensity of 2 or greater|||Percentage of participants||95% Confidence Interval|Number
2769179|NCT00744497|Secondary|Time to Prostate Specific Antigen (PSA) Progression|PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.|From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
2769190|NCT00744380|Secondary|The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)|The Riker sedation-agitation score (range 1-7) and PABS (range 0-10) are assessed hourly by the bedside nurse. Riker scores assess restlessness and cooperation. Riker scores of 5 - 7 indicate agitation, 3 - 4 represent adequate sedation and 1 - 2 represent excessive sedation. PABS assessments include domains of restlessness, muscle tone, vocalization, consolability, and facial expressions. PABS assessments of 0 represent no pain, 1 - 3 represent mild pain, 4 - 6 represent moderate pain, and ≥ 7 represent severe pain.|Duration of ICU stay, for up to 24 weeks||||percentage of assessments while on study|||Number
2769180|NCT00744497|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.|From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
2769181|NCT00744497|Secondary|Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline|The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.|At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing|||Percentage of participants||95% Confidence Interval|Number
2769182|NCT00744497|Secondary|Time to First Skeletal-related Event (SRE)|Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.|From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
2769183|NCT00744497|Secondary|Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.|At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)|Participants with at least 1 target lesion at baseline|||Percentage of participants||95% Confidence Interval|Number
2769184|NCT00744497|Primary|Overall Survival: Time From Randomization to Date of Death|Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.|From randomization to death or date of last contact (maximum reached: 45 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
2769185|NCT00744380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|The HADS consists of 14 questions, seven for anxiety and seven for depression. Each item is scored from 0 to 3, with a cut-off cumulative score of 11 for both subscales indicative of anxiety or depression. This scoring tool has been used for 30 years, possesses excellent reliability and validity, and avoids reliance conditions that are also common somatic symptoms of illness such fatigue, insomnia, and hypersomnia. The maximum score for each subscale is 21 with a maximum possible cumulative score of 42. The minimum score for each subscale is 0. The minimum cumulative score is 0|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the HADS were provided the assessment. Seven subjects were excluded.|||units on a scale||Standard Deviation|Mean
2769186|NCT00744380|Secondary|Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)|"The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = not at all, 1 = a little bit, 2 = moderately often, 3 = quite a bit, and 4 = extremely often. The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88."|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the IES-R were provided the assessment. Seven subjects were excluded.|||units on a scale||Standard Deviation|Mean
2769187|NCT00744380|Secondary|Duration of Study Drug Administration||Duration of ICU stay, up to 24 weeks||||days||Inter-Quartile Range|Median
2769188|NCT00744380|Secondary|ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)|"The ICU-SEQ assesses patient recall of their ICU experience. The ICU-SEQ assesses both psychological (e.g. fearfulness, anxiety) and physical (e.g. pain, difficulty breathing) perceptions of ICU patients who have received mechanical ventilation. It consists of 29 potentially stressful experiences with seven items specifically addressing the endotracheal tube. The extent that patients are bothered by each item is scored on a five point scale: 0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, and 4 = extremely. The cumulative score is an integer interpreted as interval data with higher scores indicating greater stressful experiences associated with the ICU. The minimum score is 0 and the maximum score possible is 116."|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the ICU-SEQ were provided the assessment. Seven subjects were excluded.|||units on a scale||Full Range|Median
2769194|NCT00744328|Primary|To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29|Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.|Week 8|Analyses presented are Last Observation Carried Forward. For women who completed the 8 week trial the percent change was measured from baseline to week 8. For non-completers, the percent change was measured from baseline to last observation.|||percentage change in SIGH-ADS29 Score||Standard Deviation|Mean
2769195|NCT00744263|Other Pre-specified|Percentage of Participants With Newly Diagnosed Chronic Medical Condition|Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.|From 1 month after vaccination up to 6 months after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.|||percentage of participants|||Number
2769196|NCT00744263|Other Pre-specified|Percentage of Participants Who Died|Deaths collected throughout the case acquisition period were presented.|From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Safety population included all participants who received study vaccine and who had any safety data.|||percentage of participants|||Number
2769197|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination|Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.|Within 7 days after vaccination|Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.|||percentage of participants||95% Confidence Interval|Number
2769198|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination|Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.|Within 7 days after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.|||percentage of participants||95% Confidence Interval|Number
2769199|NCT00744263|Secondary|Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases|VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).|Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
2769200|NCT00744263|Secondary|Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.|Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
2769259|NCT00743340|Primary|Number of Participants Who Had Access to, and Received the Intervention|This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.|Up to 586 weeks|Participants who were enrolled into the study and received study drug.|||Participants|||Count of Participants
2769201|NCT00744263|Primary|Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).|Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
2769202|NCT00744237|Secondary|Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5|[visit 5(week 0) and visit 14(week 26)]||||Unit on a scale||Standard Deviation|Mean
2769203|NCT00744237|Primary|Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26|Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.|visit 5(week 0) and visit 14(week 26)||||Percentage||Standard Deviation|Mean
2769204|NCT00744211|Other Pre-specified|Number of Other Adverse Events By Type|Other (non-serious) Adverse Events (reported by arm/group)|up to 24-hours post-CPB||||events|||Number
2769205|NCT00744211|Other Pre-specified|Sitaxsentan Levels|Sitaxsentan levels (microg/mL)|0, 6, 12 and 24 hours post-CPB||||microg/mL||Standard Deviation|Mean
2769206|NCT00744211|Secondary|Plasma Endothelin-1|Plasma Endothelin-1 (fmol/mL)|Baseline, 0, 6, 12 and 24 hours post-CPB||||fmol/mL||Standard Deviation|Mean
2769207|NCT00744211|Primary|Pulmonary Vascular Resistance|Pulmonary Vascular Resistance (d.s.cm-5)|Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB)||||dyne*second/centimeter˄5||Standard Deviation|Mean
2769208|NCT00744055|Primary|Clinician-Administered PTSD Scale|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD|12 weeks||||units on a scale||Standard Deviation|Mean
2769209|NCT00744055|Primary|Number of Drinking Days|Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use|12 weeks||||days||Standard Deviation|Mean
2769210|NCT00744042|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||h*U/L||Standard Deviation|Mean
2769211|NCT00744042|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Time at maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||hour||Standard Deviation|Mean
2769212|NCT00744042|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax)|Maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose)|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||U/L||Standard Deviation|Mean
2769213|NCT00744042|Primary|Change in Rickets Severity From Baseline to Week 24, Based on Assessment of Skeletal Radiographs Using Radiologic Global Impression of Change (RGI-C)|"A 7-point RGI-C (Radiographic Global Impression of Change) score was used to rate change in rickets severity. Scores ranged from -3 (severe worsening of rickets) to +3 (complete healing of rickets). Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings. Average scores were derived for each patient at each assessment."|24 weeks|ITT (intention to treat)|||Units on a scale||Full Range|Median
2769214|NCT00743730|Secondary|Parent Satisfaction With the Administration Technique|"Parents were asked Overall, how satisfied were you with the pain relief your child received after surgery? Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4."|parents, once at the end of study|Data was obtained from parents who completed the satisfaction survey|||units on a scale||Standard Deviation|Mean
2769215|NCT00743730|Secondary|Number of Patients Requiring Naloxone for Respiratory Depression|Number of patients requiring naloxone for respiratory depression (our most important side effect)|Daily, for up to 3 days||||Participants|||Count of Participants
2769216|NCT00743730|Primary|Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale|Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.|First 24 hours on study||||units on a scale||Inter-Quartile Range|Median
2769217|NCT00743717|Primary|Knee Score at 2 Years Post Operation|"The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess success."|within 2 years||||units on a scale||Full Range|Mean
2769218|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose||28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
2769219|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose||28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
2769220|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series||28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
2769221|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose|Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
2769222|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Toddler Dose|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
2769223|NCT00743652|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
2769224|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769225|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769226|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769289|NCT00742885|Secondary|Number of Subjects Reporting Any Medically-significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.|During the 182-day (Days 0-181) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769227|NCT00743652|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2769228|NCT00743652|Other Pre-specified|GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2769229|NCT00743652|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2769230|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769231|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769232|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769233|NCT00743652|Other Pre-specified|Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC|In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC's AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.|Baseline to 6 months after last vaccination|Safety Population|||Participants|||Number
2769234|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2|Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
2769235|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1|Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
2769236|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
2769237|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
2769238|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769239|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769240|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769241|NCT00743652|Secondary|Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769242|NCT00743652|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769243|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769257|NCT00743431|Primary|Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)|"Definitions in assessment of adverse event severity:~Mild: awareness of sign, symptom, or event, but easily~tolerated.~Moderate: discomfort enough to cause interference with usual~activity and may warrant intervention.~Severe: incapacitating with inability to do usual activities or~significantly affects clinical status, and warrants~intervention."|The observational program was conducted over a period of 2 years|Intent-to-treat (ITT) (N=214). This is also the Safety population.|||Events|||Number
2769315|NCT00742625|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
2769244|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2769245|NCT00743574|Primary|AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months|AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT|3 months|Number determined by all participants who completed all interventions and procedures|||mg/min/120min||Standard Deviation|Mean
2769246|NCT00743574|Primary|AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months|Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT|3 months|Number determined by completion of all study interventions and procedures|||µIU/ml/120min||Standard Deviation|Mean
2769247|NCT00743574|Primary|Fasting Glucose Levels at Completion of Treatment, at 3 Months|Fasting glucose levels drawn after 3 months completion during oral GTT|3 months|Number determined based on all interventions and procedures completed.|||mg/dl||Standard Deviation|Mean
2769248|NCT00743574|Primary|Fasting Insulin Levels at Study Completion After 3 Month Treatment|Fasting insulin levels at study completion after 3 month treatment|3 months intervention|Number determined by all those who completed all interventions and procedures.|||µIU/ml||Standard Deviation|Mean
2769249|NCT00743574|Primary|Participants Were Assessed at Study Completion After 3 Month Treatment|Fasting HbA1C levels at study completion after 3 month treatment|Completion|Number determined by those who completed all interventions and procedures.|||percentage||Standard Deviation|Mean
2769250|NCT00743574|Secondary|Serum Levels of C-reactive Protein at Completion of 3 Months Treatment Compared to Baseline.|Serum levels of C-reactive protein upon completion, at 3 months|3 months|All subjects who completed treatment for 3 months|||mg/L||Inter-Quartile Range|Median
2769251|NCT00743509|Secondary|Median Overall Survival Time|Median overall duration of survival.|48 weeks|All patients who completed at least one 28 day cycle|||days||95% Confidence Interval|Median
2769252|NCT00743509|Primary|Number of Patients Alive Without Disease Progression|Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm.|6 months|Patients that tolerated and completed at least one 28 day cycle of therapy were considered evaluable|||participants|||Number
2769253|NCT00743483|Primary|The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)|"The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.~CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).~Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.~Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.~The unit of CFA is %"|Final 3 days of baseline and treatment period|Per protocol|||% CFA||Standard Deviation|Mean
2769254|NCT00743444|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.|The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.|0-12 hours post first dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2.|||μmol*hours / L||Standard Deviation|Geometric Mean
2769255|NCT00743444|Secondary|Total Number Reflux Episodes 0-24 Hours Post First Dose|Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.|0-24 hours|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 2 due to insufficient impedance/pH recording time.|||Episodes||95% Confidence Interval|Geometric Mean
2769256|NCT00743444|Primary|Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose|"The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).~The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment."|0-3 hours post meal, post third dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing.|||Relaxations||95% Confidence Interval|Geometric Mean
2769258|NCT00743366|Primary|Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.~Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)||||Puffs||Standard Error|Mean
2769260|NCT00743288|Primary|Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan|Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.|24 months||||participants|||Number
2769261|NCT00743288|Primary|MTD|Phase 1: to determine MTD of melphalan in combination with panobinostat to be used in the Phase 2 portion of the study|12 months||||mg/kg melphalan|||Number
2769262|NCT00743288|Primary|Maximum Tolerated Dose (MTD)|Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study|12 months|MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.|||mg LBH589|||Number
2769263|NCT00743288|Secondary|Time to Progression||Time from the start of treatment to progressive disease|All cohorts were analyzed|||months||Full Range|Median
2769264|NCT00743288|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death|Only three patients had responses.|||months||Full Range|Median
2769265|NCT00743275|Primary|Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)|Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation|21 days post-vaccination|Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Percentage of Participants|||Number
2769266|NCT00743275|Primary|Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)|Seroprotection was defined as post-vaccination titer value of ≥ 1:40.|21 days post-vaccination|Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Percentage of Participants|||Number
2769267|NCT00743275|Primary|Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation||Day 0 and 21 days post-vaccination|Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Titers||95% Confidence Interval|Geometric Mean
2769268|NCT00743275|Primary|Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering|Days 0-3 post-vaccination|Safety profile was assessed in the intent-to-treat (ITT) population|||Participants|||Number
2769269|NCT00743262|Secondary|Device Life Time|Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)|one year||||days||Standard Deviation|Mean
2769270|NCT00743262|Secondary|Subjective Voice and Speech Quality|Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.|3 weeks||||units on a scale||Standard Deviation|Mean
2769271|NCT00743262|Primary|Short-term Feasibility Provox Vega 22.5 French|Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.|3 weeks||||Patients|||Number
2769272|NCT00743249|Secondary|Percentage of Subjects Retaining the Stent at Month 3|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|Month 3|Intent to treat|||Percentage of subjects|||Number
2769273|NCT00743249|Primary|Mean Retention Time|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|From baseline (Day 0) up to Month 3|Intent to treat|||Days||Standard Deviation|Mean
2769274|NCT00743197|Secondary|The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction.|no analyses were conducted due to the PI's departure from the institution; all work including analyses ceased upon departure- the study was not transferred with the PI. In addition, the study end points were based on changes between groups (treatment vs. usual care group) at 12 month follow up for both groups - none of the enrolled subjects made it to the final (month 12) visit.|1 year|||||||
2769275|NCT00743197|Primary|Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED).|The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.|1 year|no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit.|||participants|||Number
2769276|NCT00743145|Primary|Subjective Marijuana Effects|Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.|180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.||||units on a scale (0-100mm)||Standard Error|Mean
2769277|NCT00743119|Primary|Pain Tolerance|Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).|Within each session lasting approximately 5 minutes, for a total of five sessions|All participants who completed the study (N=30) were included in the final analysis.|||seconds||Standard Error|Mean
2769278|NCT00743106|Secondary|Postoperative Creatinine (mg/dL)|assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)|"immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"||||mg/dL||Standard Error|Mean
2769279|NCT00743106|Primary|Glomerular Filtration Rate (GFR) Percentage of Change From Baseline|Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.|percentage of change from baseline to post-operatively day 3||||percentage change||Standard Deviation|Mean
2769280|NCT00743093|Secondary|The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).||Days 1-3|A subset of the safety population was monitored for early detection of APAP-cys. This subset of subjects had APAP-cys measured at Days 1, 2, and 3 in addition to other protocol defined timepoints.|||participants|||Number
2769281|NCT00743093|Primary|The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.|ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.|serial samples for 16-40 days|The total number of subjects completing the trial was used for analysis. Subjects who withdrew early were not included.|||participants|||Number
2769282|NCT00742963|Primary|Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma||Two years||||mg/m2|||Number
2769283|NCT00742924|Secondary|Prognostic Value of Bone Resorption Markers|Blood will be collected for quantification of c-telopeptide and urine will be collected for quantification of n-telopeptide.|At baseline and at weeks 13 and 36|||||||
2769284|NCT00742924|Secondary|Secondary Limiting Toxicity|"Secondary limiting toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor.~CTC AE version 4 hematologic toxicity will be based on time to blood count recovery to an ANC ≥ 1000/µL and platelet count ≥ 100,000/µL that delays definitive surgery by more than 2 weeks."|After week 13 to the end of protocol therapy|||||||
2769285|NCT00742924|Secondary|Event-free Survival|The EFS and survival functions will be estimated by the Kaplan-Meier methodology.|Time from study enrollment to disease recurrence, death without disease progression, diagnosis of a second malignant neoplasm, assessed up to 5 years|||||||
2769286|NCT00742924|Secondary|Histologic Response as Assessed in the Primary Tumor and in Resected Metastases|"Histologic response as graded according to the system of Huvos across all specimens resected at the time of local control in the primary tumor and in resected metastases.~The best response, as quantified by maximum necrosis grading according to the system of Huvos across all specimens resected at the time of local control, will be used to quantify the effect of Induction chemotherapy."|At definitive surgery planned for 12 weeks after the start of protocol therapy.|||||||
2769287|NCT00742924|Primary|Limiting Toxicity|"The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor."|Enrollment through the first 12 weeks of therapy.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome|||participants|||Number
2769288|NCT00742885|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 181)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769316|NCT00742625|Secondary|Disease-free Survival|Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
2769290|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|From Day 0 to Day 83 following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769291|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769292|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769293|NCT00742885|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769294|NCT00742885|Secondary|Number of Subjects With Any Normal or Abnormal Urine Values|Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769295|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769296|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769297|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769298|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2769299|NCT00742885|Secondary|Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies|"A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.~The H5N1 vaccine strain included A/Indonesia antigen."|At Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
2769300|NCT00742885|Secondary|Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Titer||95% Confidence Interval|Geometric Mean
2769301|NCT00742885|Secondary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
2769302|NCT00742885|Secondary|Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Fold Increase||95% Confidence Interval|Geometric Mean
2769303|NCT00742885|Secondary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
2769304|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Titer||95% Confidence Interval|Geometric Mean
2769305|NCT00742885|Primary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2769306|NCT00742885|Primary|HI Antibody Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Fold Increase||95% Confidence Interval|Geometric Mean
2769307|NCT00742885|Primary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2769308|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2769309|NCT00742872|Primary|Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.||Within the first 8 weeks of treatment||||participants|||Number
2769310|NCT00742859|Secondary|Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)|The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.|||Number of Patients per 100 Patient years||95% Confidence Interval|Number
2769311|NCT00742859|Primary|Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode|The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.|||Number of Patients per 100 Patient years||95% Confidence Interval|Number
2769312|NCT00742781|Primary|25(OH)D3 Serum Levels|25(OH)D3 levels before and after vitamin D supplementation.|6 months||||ng/ml 25(OH)D3||Standard Error|Mean
2769313|NCT00742781|Secondary|Health Improvement|International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.|6 months|Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.|||units on a scale||Standard Error|Mean
2769314|NCT00742781|Primary|Crohn's Disease Activity Index|Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.|6 months||||units on a scale||Standard Error|Mean
2769317|NCT00742625|Primary|Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine|"DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs.~Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death."|during consolidation cycle 1 (42 days)|Participants who were registered to bortezomib consolidation were included in the analysis.|||participants|||Number
2769318|NCT00742625|Primary|Remission Induction Response|"Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML)~A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction.~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).~A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion."|2 months||||participants|||Number
2769319|NCT00742573|Primary|Hamilton Depression Scale (HAMD-17)|"Hamilton Depression Scale (HAMD-17): Scoring is based on the 17-item scale of 0-4, the higher the worse.~0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, over 24 severe depression~Minimum is 0 and the maximum score being 52"|Baseline|Adult Hispanics with MDD and Non-missing HAMD Total Score|||score on a scale||Standard Deviation|Mean
2769320|NCT00742573|Primary|Mean Time of Retention|Average number of weeks of retention of Hispanics in the treatment of MDD|52 weeks|Adult Hispanics with MDD|||weeks||Standard Deviation|Mean
2769321|NCT00742560|Secondary|Plasma Cell Myeloma Cytogenetic Subtype|Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System [ISS] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age < 55).|Screening (up to 14 days prior to dosing)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
2769322|NCT00742560|Secondary|Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)|Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.|From screening through 60-day follow up period (up to 101 months)|All participants who received at least one dose of study drug and with at least one evaluable post-dose sample.|||percentage of participants|||Number
2769323|NCT00742560|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
2769324|NCT00742560|Secondary|Time to Progression (TTP)|TTP is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression. The distribution of TTP was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the TTP distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
2769325|NCT00742560|Secondary|Duration of Response|Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
2769326|NCT00742560|Secondary|Serum Half-life (t1/2) of Elotuzumab|The serum half-life of a drug (t1/2, measured in hours) is the time necessary to reduce the plasma concentration by half. The t1/2 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
2769327|NCT00742560|Secondary|Volume of Distribution (V) of Elotuzumab|Volume of distribution (V, measured in L/kg) is the hypothetical volume of body fluid that would be required to dissolve the amount of drug needed to achieve the same concentration in the blood. The V of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
2769415|NCT00741988|Secondary|Characterization of the Toxicity in Patients With Previously Untreated Advanced NSCLC Treated With Ixabepilone and Carboplatin With and Without Bevacizumab.||18 months|||||||
2769328|NCT00742560|Secondary|Systemic Clearance (CL) of Elotuzumab|Systemic clearance (CL, measured in mL/kg/hr) is a measure of the efficiency with which a drug is irreversibly removed from the body. The CL of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
2769329|NCT00742560|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab|The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
2769330|NCT00742560|Secondary|Maximum Serum Concentration (Cmax) of Elotuzumab|The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
2769331|NCT00742560|Secondary|Mean Serum Concentrations of Elotuzumab During Cycle 1|Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.|Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)|Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.|||μg/mL||Standard Deviation|Mean
2769332|NCT00742560|Secondary|Number of Participants With Infusion Reactions|During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).|Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
2769333|NCT00742560|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
2769334|NCT00742560|Secondary|Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)|ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).|From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months|Safety population: All randomized participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2769335|NCT00742560|Primary|Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)|ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).|From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2769336|NCT00742560|Primary|Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)|MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity [DLT]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets < 10,000 cells/mm^3 that do not recover to 25,000 cells/mm^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.|4 weeks|All participants in the safety population (all randomized participants who received at least 1 dose of study drug) in the escalation cohorts (Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; and Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone [Phase 1]).|||mg/kg|||Number
2769337|NCT00742508|Secondary|Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8|Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.|||percentage||Standard Deviation|Mean
2769338|NCT00742508|Secondary|Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8|Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.|||ng/L (nanogram per Liter)||Standard Deviation|Mean
2769339|NCT00742508|Secondary|Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8|The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
2769340|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|PD Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||beats per minute||Standard Error|Mean
2769341|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||millimeters of mercury (mmHg)||Standard Error|Mean
2769342|NCT00742508|Primary|Cardiothoracic Ratio at Baseline and Week 8|Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage||Standard Deviation|Mean
2769416|NCT00741988|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Median
2769343|NCT00742508|Primary|Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8|There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
2769344|NCT00742508|Primary|Mean Change From Baseline in Weight at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||kilograms (kg)||Standard Deviation|Mean
2769345|NCT00742508|Primary|Mean Change From Baseline in Heart Rate at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||beats per minute||Standard Deviation|Mean
2769346|NCT00742508|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2769347|NCT00742508|Primary|Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8|Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
2769348|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Volume at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||femtoliters (fL)||Standard Deviation|Mean
2769349|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||picograms (pg)||Standard Deviation|Mean
2769350|NCT00742508|Primary|Mean Change From Baseline in Red Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||tebi (2 to the power of 40)/liter (Ti/L)||Standard Deviation|Mean
2769351|NCT00742508|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||gibi (2 to the power of 30)/liter (Gi/L)||Standard Deviation|Mean
2769352|NCT00742508|Primary|Mean Change From Baseline in Hematocrit at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||proportion of 1 (SI)||Standard Deviation|Mean
2769353|NCT00742508|Primary|Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||grams per liter (g/L)||Standard Deviation|Mean
2769354|NCT00742508|Primary|Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage of each WBC type in WBC count||Standard Deviation|Mean
2769355|NCT00742508|Primary|Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage of Total Creatine Kinase||Standard Deviation|Mean
2769417|NCT00741988|Secondary|Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease||18 months||||months||95% Confidence Interval|Median
2769356|NCT00742508|Primary|Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2769357|NCT00742508|Primary|Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||micromoles per liter (umol/L)||Standard Deviation|Mean
2769358|NCT00742508|Primary|Mean Change From Baseline in Amylase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||units per liter (U/L)||Standard Deviation|Mean
2769359|NCT00742508|Primary|Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||international units per liter (IU/L)||Standard Deviation|Mean
2769360|NCT00742508|Primary|Mean Change From Baseline in Albumin and Total Protein at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||grams per liter (g/L)||Standard Deviation|Mean
2769361|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||millimeters of mercury (mmHg)||Standard Error|Mean
2769362|NCT00742508|Secondary|Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 in group F who gave samples at Week 8 in the CRV-IR group; total of 15 participants, including 4 in group C who gave samples at Week 8 in the SK&F-105517-D group|||hours||Full Range|Median
2769363|NCT00742508|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Area under the plasma concentration versus time curve from time zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|Pharmacokinetic (PK) Parameter Population: all participants who received the study drug at each dose level and provided sufficient PK concentration data and the data for estimation of PK parameters (total of 13 participants, 3 gave samples at Week 8 in CRV-IR group; total of 15 participants, 4 gave samples at Week 8 in the SK&F-105517-D group)|||hours * nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2769364|NCT00742508|Secondary|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 who gave samples in group F at Week 8 in CRV-IR group; total of 15 participants, including 4 who gave samples at Week 8 in the SK&F-105517-D group)|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2769365|NCT00742508|Primary|Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)|Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.|Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D|Safety Population: all participants who received at least one dose of the investigational product|||participants|||Number
2769366|NCT00742469|Primary|Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment|The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.|14 days|The Intent to Treat (ITT) population received at least 1 dose of the study drug. For the ITT population, 99 participants were in the rifaximin group and 102 were in the placebo group. The EE consisted of105 of 106 subjects and the placebo group, 100 of 104 subjects were EE. All subject included in Safety analysis|||Participants|||Count of Participants
2769367|NCT00742417|Secondary|Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)|Percentage of patients with improved perfusion at the end of the study compared to their initial perfusion. Frontal, parietal and temporal lobes were evaluated from the quantified NeuroGam images. This rendered parametric images showed brain alterations with more than 2 standard deviations with respect to a normal data base. Initial parametric images were compared to the final ones and it was considered perfusion improvement those patients that showed less stretch and/or defect intensity.|End of study|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients|||percentage of participants|||Number
2769368|NCT00742417|Secondary|Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.|Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by Magnetic Resonance Imaging (MRI). Three measurements were made (week -2 or -1, 20 and 44). It was measured the variations versus the baseline.|Week 00 (baseline), week 20 and week 44|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients|||cubic centimetres (cc)||Standard Deviation|Mean
2769369|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~ADCS-ADL: Alzheimer's Disease Cooperative Study/Activities Of Daily Living (23 questions describing daily activity of the subject and requests the informer to describe the actions or behaviors observed. Increased autonomy associated to higher scores, maximum of 78 points and minimum of 0)~NPI: Neuropsychiatric Inventory Questions (12 symptom domains scored by frequency [range=0 to 4, higher values being more frequent] and severity [range=1 to 3, higher values being more severe], total score is sum of frequency x severity of all domains)~CDR-Sb: Clinical Dementia Rating (range=0 to 3, higher values being more severe)~ADCS-CGIC: Alzheimer's Disease Cooperative Study/Clinical Global Impression of Change (7-point Likert scale, 0=not assessed, 1=marked improvement, 2=moderate improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=moderate worsening and 7=marked worsening)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||units on a scale||Standard Deviation|Mean
2769370|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~MMSE: Mini Mental State Examination Score (range = 0 to 30, with lower values indicating impairment)~ADAS-Cog: Alzheimer's Disease Assessment Scale, Cognitive Subscale (range = 0 to 70, with higher values indicating impairment)~NPS (Neuropsychological battery): •SDMT (Symbol Digit Modalities Test, range = 0 to 110, with lower values indicating impairment), •SVF (Semantic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •PVF F, A and S (Phonetic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •BNT (Boston Naming Test, with a maximum of 15 pictures), •RAVLT (Rey Auditory Verbal Learning Test, with 15 words the patient should listen and remind)~CSDD (Cornell Scale for Depression in Dementia, 0 = none; 1 =mild or intermittent; 2 = severe)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||units on a scale||Standard Deviation|Mean
2769371|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (Innotest).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using Innotest commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
2769372|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
2769373|NCT00742417|Secondary|Aβ1−40 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−40 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
2769418|NCT00741988|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months||||percentage of participants||95% Confidence Interval|Number
2769374|NCT00742417|Secondary|P-Tau and Tau CSF Levels Throughout the Study.|Levels of Tau and P-tau in CSF throughout the treatment phase and the follow-up phase (week 44).|Baseline, week 02, week 08, week 20, week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
2769375|NCT00742417|Primary|Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.|Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.|Baseline and up to week 44|The efficacy analyses were performed with the full analysis set (FAS) population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions (or sham procedures) during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||95% Confidence Interval|Least Squares Mean
2769376|NCT00742391|Secondary|Patients With Partial Clearance of Actinic Keratosis (AKs)|Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.|baseline and 57 days|Intention to treat population|||participants|||Number
2769377|NCT00742391|Primary|Patients With Complete Clearance of Actinic Keratosis (AKs)|Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population|||Participants|||Number
2769378|NCT00742326|Secondary|Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo|Change in Glucose Area Under the Curve from standard oral glucose challenge ( baseline to 2 hours): Week 48 - Baseline values|48 weeks|One subject in the placebo arm was discontinued due to health issues and does not have a 48 week OGTT available|||mg*120 minutes/dL||Standard Deviation|Mean
2769379|NCT00742326|Primary|Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.|Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline|48 weeks|Two subjects (one in each group) did not have a follow up MRI for comparision to baseline. One developed claustrophobia and could not tolerate MRI and one was discontinued from study due to other illnesses.|||percentage of hepatic fat on MRS||Standard Deviation|Mean
2769380|NCT00742313|Primary|Number of Participants With Decreased Bleeding|The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.|14 days|Six participants were not analyzed due to early termination of study|||participants|||Number
2769381|NCT00742274|Primary|Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation|"Subjects with any of the following met this composite outcome:~partial/no false lumen thrombosis~aortic rupture~aortic dilatation~lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)"|1 year|Intent to Treat (ITT)|||participants|||Number
2769382|NCT00742235|Primary|Baseline 25-OH Vitamin D Level||Baseline||||ng/ml||Inter-Quartile Range|Median
2769383|NCT00742235|Primary|hCAP18 Levels||Baseline||||ng/ml||Standard Deviation|Mean
2769384|NCT00742209|Other Pre-specified|Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17|"Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale."|Week 17|ITT Population|||Percentage of Patients|||Number
2769385|NCT00742209|Other Pre-specified|Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)|Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.|Week 17|ITT Population|||Hours||Standard Error|Mean
2769386|NCT00742209|Other Pre-specified|Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17|The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.|Week 17|ITT Population|||Points on a scale||Standard Error|Mean
2769387|NCT00742209|Other Pre-specified|Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17|The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.|Baseline and Week 17|ITT Population|||units on a scale||Standard Error|Mean
2769419|NCT00741936|Secondary|Serum Glutamic Oxaloacetic Transaminase (SGOT)||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
2769388|NCT00742209|Secondary|"Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17"|"The CGIC is a single question measured on a 7-point Likert Scale. (1 = very much improved; 2= much improved, and 7 = very much worse) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'."|Week 17|ITT Population|||Participants|||Number
2769389|NCT00742209|Secondary|"Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17"|"The PGIC is a single question measured on the 7-point Likert Scale (1 = very much improved; 2 = much improved; 7 = very much worse). A responder is defined as being very much improved or much improved."|Week 17|ITT Population|||participants|||Number
2769390|NCT00742209|Secondary|Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods|A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.|Baseline to the Last 4 weeks of treatment|ITT Population|||percentage of participants|||Number
2769391|NCT00742209|Secondary|Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia|The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Percentage of MA with migraine symptoms||Standard Error|Mean
2769392|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use|The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Migraine Medication Doses||Standard Error|Mean
2769393|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use|The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Days||Standard Error|Mean
2769394|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use|The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Migraine Medication Dose||Standard Error|Mean
2769395|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered|The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Medication Doses Admin.||Standard Error|Mean
2769396|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use|The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Days||Standard Error|Mean
2769397|NCT00742209|Secondary|Change From Baseline in the Mean Peak Migraine Pain Severity|Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Scores on a Scale||Standard Error|Mean
2769398|NCT00742209|Secondary|Change From Baseline in the Mean Migraine Attack Duration|The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Hours||Standard Error|Mean
2769399|NCT00742209|Secondary|Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)|A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Headache Periods (MHP)||Standard Error|Mean
2769400|NCT00742209|Secondary|Adjusted Mean Change From Baseline in the Number of Migraine Attacks|A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Attacks||Standard Error|Mean
2769420|NCT00741936|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
2769401|NCT00742209|Secondary|Mean Change From Baseline in the Number of MHD in All Study Phases|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Headache Days (MHD)||Standard Error|Mean
2769402|NCT00742209|Primary|Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|Intent to treat (ITT). There were 3 subjects who were randomized but did not take investigational product, and, therefore were not included in the Safety, ITT, or Per Protocol (PP) population.|||Migraine Headache Days (MHD)||Standard Error|Least Squares Mean
2769403|NCT00742183|Primary|Compare the Costs of Using the Interventions (Direct and Indirect)|"The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods.~The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr"|August 2008-August 2009|Primary analysis: the Intention To Treat (ITT) population will include all patients subject to at least one post-randomisation treatment and that provide some data for the primary endpoint. If there are any patients included which do not comply with the inclusion/exclusion criteria they will be included in the ITT population|||dollars||95% Confidence Interval|Mean
2769404|NCT00742170|Secondary|Opioid Craving (Self-report)|Self-report on scale of 3 to 30 (higher number indicates more craving)|at 2-weeks post discharge||||units on a scale||Standard Deviation|Mean
2769405|NCT00742170|Primary|Percent of Participants Using Drugs||2 weeks following discharge||||percent|||Number
2769406|NCT00742079|Secondary|Change in the Maudsley Assessment of Delusions Scale|This scale is a one-question item added on to the Bead Task. The one item asks for a certainty rating, from 1-3. Higher scores represent better outcomes.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2769407|NCT00742079|Secondary|Change in Bead Task Score Measuring Probabilistic Reasoning|The Bead task is a reasoning task, where the number of beads guessed is the numeric value represented in the data. The lower end range is 1, and there is no upper range limit. Higher scores represent better outcomes.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2769408|NCT00742079|Secondary|Change in Beck Cognitive Insight Scale (BCIS)|"The BCIS is a 15-item self-report scale with Likert items 0-3. It consists of a composite score, where higher scores represent better outcomes, and there are 2 subscales: 1) Self-Reflectiveness (higher scores represent better outcomes) and 2) Self-Certainty (higher scores represent worse outcomes). The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty.~Step 1. Score every item on the BCIS from 0 to 3 according to the following rule:~Do Not Agree at All = 0, Agree Slightly = 1, Agree a Lot = 2, Agree Completely = 3 Step 2. Calculate self-reflectiveness subscale: sum items 1, 3, 4, 5, 6, 8, 12, 14, and 15.~Step 3. Calculate self-certainty subscale: sum items 2, 7, 9, 10, 11, and 13. Step 4. Calculate BCIS composite index: self-reflectiveness minus self-certainty."|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2769409|NCT00742079|Secondary|Change in Psychotic Rating Scales (PSYRATS) Delusion Score|The Delusions subscale is a 6 item clinician administered scale, with Likert items 0-4 and range is 0-24. Higher scores represent worse outcomes|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2769410|NCT00742079|Primary|Change in Alternative Beliefs Assessment|Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2769411|NCT00742053|Primary|Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction|In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.|during catheter insertion||||cm||Standard Deviation|Mean
2769412|NCT00742001|Secondary|Count of Participants With Serious Adverse Events (SAE)||28-days post autologous infusion of RBCs||||Participants|||Count of Participants
2769413|NCT00742001|Secondary|Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival|The objective of measuring 28-day survival was to identify the potential total lifespan of labeled RBCs in circulation. Normal, native RBCs remain in circulation for a maximum of approximately 120 days; by using the 51Cr half-life of approximately 28 days, and its elution rate from labeled RBCs, the survival of the labeled cells can be predicted.|28-days post autologous infusion of RBCs||||days||Standard Deviation|Mean
2769414|NCT00742001|Primary|Red Blood Cell (RBC) Recovery|The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.|24-hour post autologous infusion of RBCs||||percentage of recovered RBCs||Standard Deviation|Mean
2769423|NCT00741936|Primary|Responder of Complete Spontaneous Bowel Movement (CSBM)|Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|End of treatment (wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
2769424|NCT00741936|Secondary|Success of Blinding|The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.|End of follow-up (Wk18)|Only for subjects attended the last follow-up visit on Wk 18.|||participants|Participants||Number
2769425|NCT00741936|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Wk 6, 10 & wk 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
2769426|NCT00741936|Secondary|Changes on Individual Symptom Scores|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2769427|NCT00741936|Secondary|Complete Spontaneous Bowel Movement (CSBM)||Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
2769428|NCT00741936|Secondary|Bowel Movement||Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
2769429|NCT00741936|Secondary|Responder of Complete Spontaneous Bowel Movement (CSBM)|"Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.~CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours."|End of follow up (wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
2769430|NCT00741858|Primary|Physical Health Quality of Life|Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)|7 years||||units on a scale||Standard Error|Mean
2769431|NCT00741819|Secondary|Drug Administration Activities Questionnaire|Change in tasks from Baseline to Week 12. At Baseline and Week 12, subjects provided information related to the daily administration and time requirements of inhaled iloprost (Baseline) and inhaled treprostinil (Week 12).|Baseline and 12 weeks|Subjects who completed the questionnaire at Baseline and Week 12.|||minutes||Standard Deviation|Mean
2769432|NCT00741819|Secondary|World Health Organization (WHO) Functional Class|Change in WHO Functional Class (FC) from Baseline to Week 12. Data presented as percent of subjects who either improved FC, worsened FC, or had no change in FC from Baseline to Week 12.|Baseline and 12 Weeks|Subjects still enrolled at Week 12 with a WHO Functional Class at Baseline and Week 12.|||percentage of subjects|||Number
2769433|NCT00741819|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)|Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.|Baseline and Week 12|Subjects with a NTproBNP sample drawn at Baseline and Week 12|||pg/mL||Full Range|Median
2769434|NCT00741819|Secondary|Patient Impression of Change|The patient impression of change (PIC) was three single therapy-related questions related to the subjects overall impression of the transition from inhaled iloprost to inhaled treprostinil. Subjects were surveyed related to their overall impression of the transition from inhaled iloprost to inhaled treprostinil at Week 12.|Baseline and 12 weeks|Subjects who completed questionnaire at Baseline and Week 12|||percentage of patients|||Number
2769435|NCT00741819|Secondary|Treatment Satisfaction Questionnaire of Medication (TSQM)|Change in TSQM score from Baseline to Week 12. The TSQM is a validated instrument (Health and Quality of Life Outcomes 2004, 2:12) that measures major dimensions of patient satisfaction with medications. The questionnaire is comprised of 15 questions which fall into one of four categories; Effectiveness, Side-Effects, Convenience, and Global Satisfaction. Responses are scaled on a seven point bipolar scale from 'Extremely Satisfied' to 'Extremely Dissatisfied' where higher scores indicate improvements (total scores from 0-100). The questionnaire was completed at Baseline and Week 12. The Baseline questionnaire focused on the subject's satisfaction with inhaled iloprost treatment, while the questionnaire completed at Week 12 focused on the subject's satisfaction with inhaled treprostinil.|Baseline and 12 weeks|Subjects who completed the TSQM at Baseline and Week 12. Total analysis population was less for the Convenience Score (N=67) and Global Satisfaction Score (N=66).|||units on a scale||Full Range|Mean
2769436|NCT00741819|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 12. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 12 weeks|Subjects who were still enrolled and completed the questionnaire at Baseline and Week 12. Total analysis population was less for the activity score and total score (N = 67).|||units on a scale||Full Range|Mean
2769437|NCT00741819|Secondary|Six-minute Walk Distance (6MWD)|Change in 6MWD from Baseline to Week 12. The 6-minute walk test (6MWT) was conducted at Baseline (10-30 minutes following the last dose of inhaled iloprost) and at Week 12 (10-60 minutes following the dose of inhaled treprostinil). The change in distance (meters) between Baseline and Week 12 is reported below.|Baseline and 12 weeks|Subjects enrolled at Week 12 visit.|||meters||Full Range|Median
2769438|NCT00741819|Primary|Number of Adverse Events|Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.|up to 24 months|All subjects who received at least one dose of inhaled treprostinil were included in the safety analysis population.|||number of events|||Number
2769439|NCT00741611|Secondary|Number of Participants With Acute Procedural Success in Mesh Treated Patients.|Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter|During the mesh ablation procedure|All mesh treated patients.|||participants|||Number
2769440|NCT00741611|Secondary|Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.|Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.|12 months|All mesh treated patients.|||participants|||Number
2769441|NCT00741611|Primary|Number of Participants With Freedom From Symptomatic Atrial Fibrillation|Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.|12 months|All treated patients||||||
2769442|NCT00741611|Primary|Number of Participants With Serious Atrial Fibrillation Events|Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.|12 months|All treated patients.|||participants|||Number
2769443|NCT00741611|Primary|Number of Participants With Major Complications|A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.|12 months|Patients who were treated with the HD Mesh Ablation System|||participants|||Number
2769444|NCT00741598|Secondary|Quality of Life Satisfaction Questionnaire (Q-LES-Q)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.~The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning"|Screening||||units on a scale||Standard Deviation|Mean
2769445|NCT00741598|Secondary|The Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).|Baseline, Weeks 4, 8, 12, and 16||||units on a scale||Standard Deviation|Mean
2769446|NCT00741598|Primary|The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16|"Conner's CPT (Conner's Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter X. The person must refrain from clicking if they see the letter X presented. Clicking to the letter X is a commission error, not clicking to other letters are omission errors.~The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)"|Measured at screening; baseline; and Weeks 4, 8, 12, and 16||||total number of errors||Standard Deviation|Mean
2769447|NCT00741598|Primary|Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16|"WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules.~The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16"|Measured at screening and Week 16||||number of card choices made||Standard Deviation|Mean
2769448|NCT00741598|Primary|Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16|"CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are:~CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16."|Measured at screening and Week 16||||number of total words remembered||Standard Deviation|Mean
2769449|NCT00741468|Primary|Plasma AUC Ratio of Day 1 and Day 8|"Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition.~For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used."|8 days|One subject had concentrations of Proellex (CDB-4124 and CDB-4453) that were below the lower level of quantitation at all time points tested and was excluded from the pharmacokinetic analyses.|||Ratio of geometric means Day 8 to Day 1||90% Confidence Interval|Mean
2769474|NCT00741104|Secondary|Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
2769450|NCT00741390|Secondary|Reported Device Preference Within Lancing Pair at Visit 2|"After each pair of 4 lancings, the subject was asked: Which of the two devices did you find more comfortable, overall? The choices were: first lancing, second lancing or equivalent. The Stated Preference row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The No Preference row includes lancing pairs with preference of equivalent or no answer."|Approximately Day 3 (Visit 2)|Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data.|||lancing pairs|||Number
2769451|NCT00741390|Secondary|Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)|"The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs.~After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second."|Approximately Day 3 (Visit 2)|61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.|||mm||Standard Deviation|Mean
2769452|NCT00741390|Primary|Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)|In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.|Approximately Day 3 (Visit 2)|Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome.|||mm||Standard Deviation|Mean
2769453|NCT00741390|Primary|Blood Sample of Sufficient Volume to Yield a Valid Meter Reading|Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.|Study Day 1 (Visit 1)|BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.|||Participants|||Number
2769454|NCT00741338|Secondary|Percent Reduction of Urinary Glycosaminoglycan (uGAG) Level From Baseline to the End of Treatment/Early Withdrawal|Urinary Glycosaminoglycan (uGAG) Levels: concentration of glycosaminoglycan (GAG) relative to creatinine in urine. A greater decrease in uGAG level indicates a greater response.|Baseline, end of treatment/early withdrawal (up to 24 weeks after start of full-dose laronidase therapy)|Safety population included all participants who received any study drug treatment.|||percent change in uGAG level||Full Range|Median
2769455|NCT00741338|Primary|Number of Participants Who Achieved Immune Tolerance Induction|Immune tolerance induction success was defined as development of an anti-laronidase immunoglobulin G (IgG) antibody titer less than or equal to (<=) 1:3200 after 24 weeks of receiving full-dose (0.58 mg/kg) laronidase therapy.|24 weeks after start of full-dose laronidase therapy|Safety population included all participants who received any study drug treatment.|||participants|||Number
2769456|NCT00741286|Secondary|Number of Patients With First Recurrent Stroke of Any Type||90 days||||participants|||Number
2769457|NCT00741286|Primary|The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study|The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling's PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.|14 days and 90 days from the baseline TCD study|Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome.|||ratio||Standard Deviation|Mean
2769458|NCT00741273|Primary|Proellex Half-life (T1/2)|Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours||||Hours||Standard Deviation|Mean
2769459|NCT00741273|Secondary|Area Under the Curve (AUC0-t) for Proellex|AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.|48 hours||||ng x min/L||Standard Deviation|Mean
2769460|NCT00741273|Primary|Maximum Blood Concentration (Cmax)|Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours||||ng/L||Standard Deviation|Mean
2769475|NCT00741104|Primary|Dosing Interval Between the Infliximab Infusions|Patients were asked as part of the Remicade questionnaire what dosing interval they were on.|Measured from the Remicade Questionnaire at first (and only) study visit||||participants|||Number
2769476|NCT00741091|Secondary|Device Malfunction|Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.|30 days||||Devices|||Number
2769461|NCT00741260|Primary|Maximum Tolerated Dose (MTD) of Capecitabine|MTD reflects the highest dose of capecitabine in combination with neratinib that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.|From first dose date to day 21.|All patients in the safety population in part 1 (dose-escalation) of the study.|||mg/m^2|||Number
2769462|NCT00741260|Primary|Maximum Tolerated Dose (MTD) of Neratinib|MTD reflects the highest dose of neratinib plus capeciteabine that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.|From first dose date to day 21.|All patients in the safety population in part 1 (dose-escalation) of the study.|||mg|||Number
2769463|NCT00741260|Secondary|Duration of Response|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From start date of response to first PD/death, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||weeks||95% Confidence Interval|Median
2769464|NCT00741260|Secondary|Clinical Benefit Rate|The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From first dose date to progression or last tumor assessment, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||percentage of participants||95% Confidence Interval|Number
2769465|NCT00741260|Secondary|Overall Response Rate|Number of Subjects with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||percentage of participants||95% Confidence Interval|Number
2769466|NCT00741260|Primary|Number of Participants With Dose Limiting Toxicities|Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).|From first dose date to day 21|Safety population|||Participants|||Count of Participants
2769467|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat|Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat|Baseline and after enalaprilat||||Wood units per metre squared||Full Range|Median
2769468|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat||Baseline and after enalaprilat||||l/min/m2||Inter-Quartile Range|Median
2769469|NCT00741104|Primary|Number of Patients Agreeing to Participate in a Dose Reduction Study|"As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study?"|Measured from the Remicade Questionnaire at first (and only) study visit|Out of the 363 subjects in the analysis, 361 subjects answered this question.|||participants|||Number
2769470|NCT00741104|Primary|Patient Response to Increased Dosing Interval|"Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative."|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.|||participants|||Number
2769471|NCT00741104|Primary|Reason for Extending Dosing Interval|Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.|||participants|||Number
2769472|NCT00741104|Secondary|Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
2769477|NCT00741091|Secondary|System Technical Success|System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.|30 days|To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.|||Participants|||Number
2769478|NCT00741091|Secondary|Target Lesion Revascularization|Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.|30 days||||Participants|||Number
2769479|NCT00741091|Secondary|Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)|Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.|30 days||||Participants|||Number
2769480|NCT00741091|Primary|Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)|Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).|30 days|All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.|||Participants|||Number
2769481|NCT00741039|Primary|Determine Response Rate of Patients > or = to 65 Yrs Diagnosed|For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).|8-16 weeks following vaccination.||||participants|||Number
2769482|NCT00741026|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|3 Days||||mmHg||Standard Error|Mean
2769483|NCT00741026|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|3 Days||||mmHg||Standard Error|Mean
2769484|NCT00741026|Secondary|Heart Rate|Heart Rate|3 Days||||beats per minute||Standard Error|Mean
2769485|NCT00741026|Secondary|BMI|BMI|3 Days||||kg / m2||Standard Error|Mean
2769486|NCT00741026|Secondary|Body Weight|Body Weight|3 Days||||kg||Standard Error|Mean
2769487|NCT00741026|Secondary|Total Cholesterol|Total Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
2769488|NCT00741026|Secondary|LDL Cholesterol|LDL Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
2769489|NCT00741026|Secondary|Triglycerides|Triglycerides|3 Days||||mg/dl||Standard Deviation|Mean
2769490|NCT00741026|Secondary|HDL Cholesterol|HDL Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
2769491|NCT00741026|Primary|Plasma Free Fatty Acid|Plasma Free Fatty Acid|3 Days||||mM||Standard Deviation|Mean
2769492|NCT00741026|Primary|Oral Glucose Tolerance|Oral Glucose Tolerance|3 Days||||min*mg/dl||Standard Deviation|Mean
2769493|NCT00741026|Primary|Plasma Leptin|Leptin following placebo or olanzapine treatment|3 Days||||ng/ml||Standard Deviation|Mean
2769494|NCT00741013|Secondary|Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation|Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.|24 hours after endotoxin instillation||||cells per cubic mm||Standard Deviation|Mean
2769495|NCT00741013|Primary|Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation|Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment|24 hours after endotoxin instillation||||Change in Ki||Standard Deviation|Mean
2769496|NCT00740870|Secondary|Functional Assessment (NYHA Classification)|Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.|6 Months|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant.|||Participants|||Count of Participants
2769497|NCT00740870|Secondary|Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)|Deaths (all-cause, procedural and device-related) at 5 years|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of subjects||95% Confidence Interval|Number
2769498|NCT00740870|Secondary|Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit|Freedom From Surgical Replacement of the RVOT Conduit|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
2769499|NCT00740870|Secondary|Kaplan-Meier Freedom From Catheter Re-intervention on TPV|All Catheter Re-intervention on TPV at 5 years|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
2769500|NCT00740870|Secondary|Kaplan-Meier Freedom From Major Stent Fracture at 5 Years|Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
2769501|NCT00740870|Secondary|Serious Device-related Adverse Event|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|5 years|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.|||percentage of subjects|||Number
2769502|NCT00740870|Secondary|Serious Procedural Adverse Event (AE)|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of subjects|||Number
2769503|NCT00740870|Secondary|Procedural Success|"Procedural success is a composite outcome defined as:~Melody TPV fixated within the desired location~Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant~Less than mild pulmonary regurgitation by angiography post-implant~Free of explant at 24 hours post-implant"|Within 24 Hours post implant|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).|||percentage of subjects|||Number
2769504|NCT00740870|Primary|Kaplan-Meier Freedom From TPV Dysfunction|"To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:~Hemodynamic dysfunction of the TPV~Moderate or greater pulmonary regurgitation, and/or~Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg~RVOT reoperation for conduit dysfunction or device-related reasons~Catheter re-intervention on the TPV"|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
2769505|NCT00740857|Secondary|Time to First Perceptible Relief|The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.|||minutes||95% Confidence Interval|Median
2769506|NCT00740857|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours|TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
2769507|NCT00740857|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours|SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
2769508|NCT00740857|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points|PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
2769509|NCT00740857|Secondary|Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours|SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
2769510|NCT00740857|Secondary|Pain Relief (PR) Scores at Individual Time Points|"Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken."|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
2769511|NCT00740857|Secondary|Pain Intensity Difference (PID) Scores at Each Individual Time Points|PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
2769512|NCT00740857|Primary|Time to Meaningful Pain Relief|"Subjects evaluated the time to First Perceptible Relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to Meaningful Relief by depressing a second stopwatch at the moment they first began to experience meaningful relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better."|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.|||minutes||95% Confidence Interval|Median
2769513|NCT00740831|Primary|Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist|"Difference in percentage of subjects reporting moderate or severe hot flushes:~Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17."|Up to week 17|Safety population|||percentage of patients|||Number
2769514|NCT00740831|Primary|Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist|Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples|Week 13 visit|Safety population|||log 10 (log pg/ml) E2||Standard Error|Mean
2769515|NCT00740831|Secondary|Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13|"Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.~The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10)."|3 months|Per protocol|||Log 10 (Log cm3) Total volume||Standard Error|Mean
2769516|NCT00740831|Primary|Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|3 months|Per protocol|||percentage of patients|||Number
2769517|NCT00740792|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
2769518|NCT00740792|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative value is suggestive of improvement."|day 1 to14|Intent to Treat (ITT)population includes all subjects who were randomized and had at least one post baseline efficacy observation.|||units on a scale||Standard Deviation|Least Squares Mean
2769519|NCT00740792|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement."|day1 to 14 days|Intent-to-Treat(ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
2769520|NCT00740779|Primary|National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.|Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a 0 to 43 scale||Standard Deviation|Mean
2769521|NCT00740727|Secondary|Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up|"Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.~Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back)."|2 days|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
2769522|NCT00740727|Secondary|Number of Participants With Pain During EASI Infusion|Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
2769523|NCT00740727|Primary|Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose|Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
2769524|NCT00740727|Primary|Number of Participants With Successfully Placed EASI Lines|"Ability of Basic Life Support (BLS) providers to place EASI access lines.~The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed)."|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
2775034|NCT00706563|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|At Day 0 and 21||||subjects|||Number
2769525|NCT00740714|Secondary|Adverse Experiences: Insomnia: Moderate/Severe|Number of participants with moderate/severe insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769526|NCT00740714|Secondary|Adverse Experiences: Back Pain: Moderate/Severe|Number of participants with moderate/severe back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769527|NCT00740714|Secondary|Adverse Experiences: Anxiety: Moderate/Severe|Number of participants with moderate/severe anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769528|NCT00740714|Secondary|Adverse Experiences: Constipation: Moderate/Severe|Number of participants with moderate/severe constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769529|NCT00740714|Secondary|Adverse Experiences: Depression|Number of participants with depression|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769530|NCT00740714|Secondary|Adverse Experiences: Hypertension|Number of participants with hypertension|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769531|NCT00740714|Secondary|Adverse Experiences: Nausea|Number of participants with nausea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769532|NCT00740714|Secondary|Adverse Experiences: Urinary Tract Infection|Number of patients with urinary tract infections|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769533|NCT00740714|Secondary|Adverse Experiences: Headache|Number of participants with headache|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769534|NCT00740714|Secondary|Adverse Experiences: Diarrhoea|Number of participants with diarrhoea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769535|NCT00740714|Secondary|Adverse Experiences: Nasopharyngitis|Number of participants with nasopharyngitis|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769536|NCT00740714|Secondary|Adverse Experiences: Tremor|Number of participants with tremor|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769537|NCT00740714|Secondary|Adverse Experiences: Anxiety|Number of participants with anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769538|NCT00740714|Secondary|Adverse Experiences: Insomnia|Number of participants with insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769539|NCT00740714|Secondary|Adverse Experiences: Constipation|Number of participants with constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769540|NCT00740714|Secondary|Adverse Experiences: Back Pain|Number of participants with back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
2769541|NCT00740714|Secondary|CoQ10 Levels in Plasma|Based on samples analyzed to date|Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants have been included and data is based on samples analyzed to date.|||ug/ml||Standard Deviation|Mean
2769542|NCT00740714|Secondary|Change in Hoehn & Yahr Score From Baseline to 16 Months|The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
2769543|NCT00740714|Secondary|Change in Symbol Digit Modalities Test From Baseline to 16 Months|The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
2769544|NCT00740714|Secondary|Change in PD Quality of Life Scale From Baseline to 16 Months|The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
2769545|NCT00740714|Secondary|Change in Modified Rankin Scale From Baseline to 16 Months|The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
2769546|NCT00740714|Secondary|Change in Modified Schwab & England Independence Scale From Baseline to 16 Months|This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
2769547|NCT00740714|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily.|||units on a scale||Standard Error|Least Squares Mean
2769548|NCT00740636|Primary|The Objective Overall Response|"The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years||||participants|||Number
2769549|NCT00740597|Primary|Wound Complication Rate|"Major wound complications up to 4 months post surgery include:~Complications requiring a secondary operation under general or regional anesthesia for wound care.~Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days."|1 year|The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial.||||||
2769550|NCT00740584|Secondary|Number of Participants With Adverse Experiences|Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product|Approximately 13 weeks|All Enrolled|||Participants|||Count of Participants
2769551|NCT00740584|Primary|HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)|"The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture.~The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has."|at 3 hours||||percent anti-viral activity||Inter-Quartile Range|Median
2769552|NCT00740480|Secondary|Tissue Reaction to Implant|None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.|One week post surgery|ITT|||participants|||Number
2769553|NCT00740480|Primary|Coaptation (Tissue Approximation)|Complete tissue approximation at one week.|One week post surgery|ITT|||participants|||Number
2769554|NCT00740376|Secondary|The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively|"For both the Tibial & Femoral Components the following were recorded:~Implant Subsidence > 2mm (recorded for the tibial component only) Implant Loosening > 2deg Radiolucent Line (RLL) in >50% zones Progressive RLL Osteolysis ≥ 5mm"|Month 24 postoperative||||Implants|Implants||Count of Units
2769555|NCT00740376|Secondary|Number of Implants With Any Device-related Complications||Month 24 postoperative||||Implants|Implants||Count of Units
2769556|NCT00740376|Secondary|Survival Rate Using Kaplan-Meier Survival Curves|Kaplan-Meier survival curves will be plotted for All Enrolled investigational devices and All Enrolled control devices on the same graph to facilitate graphical comparisons of survivorship over time.|Month 24 postoperative||||Implants|Implants||Count of Units
2769557|NCT00740376|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)|"Knee injury and Osteoarthritis Outcome Score (pain): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (symptoms): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (activities of daily living (ADL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport/rec): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life (QOL)): 0 (worst) - 100 (best)~Knee injury and Osteoarthritis Outcome Score (sport and recreation): 0 (worst) - 100 (best)~Knee injury and Osteoarthritis Outcome Score (quality of life): 0 (worst) - 100 (best)"|Month 24 postoperative||||score on a scale|Implants|Standard Deviation|Mean
2769558|NCT00740376|Secondary|Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)|HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best)|Month 24 postoperative||||score on a scale|Implants|Standard Deviation|Mean
2769559|NCT00740376|Secondary|American Knee Society Score (AKSS) (Total, Pain & Function Scores)|American Knee Society Score (AKSS) Total Score - Range: 0 (worst) - 100 (best) Pain Score - Range: 0 (worst) - 50 (best) Function Score - Range: 0 (worst) - 100 (best)|Month 24 postoperative||||score on a scale|Implants|Standard Deviation|Mean
2769560|NCT00740376|Primary|The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.|"CCS success criteria includes the following:~Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement;~No radiographic failure: No radiolucent lines >1mm in >50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) > 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations > 2 degrees;~No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery."|Month 24 postoperative||||Implants|Implants||Count of Units
2769561|NCT00740220|Primary|Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)|The kappa statistic is a measure of the quality of a test. It is a ratio.|All three 6MWTs should take place within 30 days||||Ratio|||Number
2769562|NCT00740207|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose||||Participants|||Number
2769563|NCT00740207|Secondary|The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.|Immediately postdose|Patients who did not deviate from the planned protocol.|||Participants|||Number
2769564|NCT00740207|Primary|Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.|Immediately prior to power injection run and again immediately following power injection run|Patients who did not deviate from the planned protocol.|||Participants|||Number
2769565|NCT00740181|Primary|Response Rate|"Complete Response/Complete Remission:~Complete remission (CR) is defined as the presence of all of the following:~Peripheral blood - No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~No Auer rods~Less than 5% blast cells.~CBC and bone marrow criteria must be met within one week of each other.~Hemoglobin 9g/dl or greater~Neutrophil count >1000 and platelet count >100,000.~RBC Transfusion free for 2 weeks."|within 30 days of last treatment||||participants|||Number
2769566|NCT00740051|Secondary|The Change in FPG From Baseline by Visit Over Time|This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.|Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)|||mg/dL||Standard Deviation|Mean
2769567|NCT00740051|Secondary|The Change in HbA1c From Baseline by Visit Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.|Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)|||percent||Standard Deviation|Mean
2769568|NCT00740051|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.|||percent of patients|||Number
2769569|NCT00740051|Secondary|Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|FAS patients with baseline HbA1c >= 6.5%. Patients without a value at Week 18 were analysed as non-responders.|||percent of patients|||Number
2769570|NCT00740051|Secondary|Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|Full Analysis Set (FAS) patients with baseline HbA1c >= 7.0%. Patients without a value at week 18 were analysed as non-responders.|||percent of patients|||Number
2769571|NCT00740051|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).|Baseline and week 18|All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).|||mg/dl||Standard Error|Mean
2769572|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Final Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
2769573|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Interim Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
2775035|NCT00706563|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|At Day 0 and 21||||titer||95% Confidence Interval|Geometric Mean
2769574|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)|Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.|||liters||95% Confidence Interval|Number
2769575|NCT00739999|Secondary|Percent Change From Baseline in Flow-Mediated Dilatation at Week 8|"Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%.~."|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.|||percent change in FMD||Standard Deviation|Mean
2769576|NCT00739999|Secondary|Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.|||FMD||Standard Deviation|Mean
2769577|NCT00739999|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = [VLDL-C at observation minus VLDL-C at Week 0] divided by VLDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in VLDL-C||Standard Deviation|Mean
2769578|NCT00739999|Secondary|Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
2769579|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = [Apo B at observation minus Apo B at Week 0] divided by Apo B at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in Apo B||Standard Deviation|Mean
2769580|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein B (Apo B)|Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||g/L||Standard Deviation|Mean
2769581|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = [Apo A-1 at observation minus Apo A-1 at Week 0] divided by Apo A-1 at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in Apo A-1||Standard Deviation|Mean
2769582|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||g/L||Standard Deviation|Mean
2769583|NCT00739999|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = [HDL-C at observation minus HDL-C at Week 0] divided by HDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in HDL-C||Standard Deviation|Mean
2769584|NCT00739999|Secondary|Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
2769585|NCT00739999|Secondary|Percent Change From Baseline in Triglycerides (TG)|Triglycerides (TG): percent (%) change from baseline by treatment over time = [TG at observation minus TG at Week 0] divided by TG at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in TG||Standard Deviation|Mean
2769586|NCT00739999|Secondary|Absolute Change From Baseline in Triglycerides (TG)|Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
2769587|NCT00739999|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Total cholesterol (TC): percent (%) change from baseline by treatment over time = [TC at observation minus TC at Week 0] divided by TC at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in TC||Standard Deviation|Mean
2769588|NCT00739999|Secondary|Absolute Change From Baseline in Total Cholesterol (TC)|Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
2769589|NCT00739999|Secondary|Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = [LDL-C at observation minus LDL-C at Week 0] divided by LDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in LDL-C||Standard Deviation|Mean
2769590|NCT00739999|Secondary|Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|Pharmacodynamic (PD) analysis population: all enrolled subjects who received ≥ 1 dose of study drug and had ≥ 1 PD parameter measurement.|||mmol/L||Standard Deviation|Mean
2769591|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)|Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.|||L/hr|||Number
2769592|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Systolic Blood Pressure Response|Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
2769593|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response|Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
2769594|NCT00739973|Secondary|Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study|Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
2769595|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769596|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769597|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769598|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769599|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769600|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769601|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769602|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All randomized patients who received the study medication.|||mm Hg||Standard Error|Least Squares Mean
2769603|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769635|NCT00739934|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2776327|NCT00697593|Primary|Biochemistry - Alkaline Phosphatase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||IU/L||Standard Deviation|Mean
2769604|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769605|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769606|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769607|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769608|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769609|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769610|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769710|NCT00738894|Secondary|Number of Subjects With Effective Closure in Test (Device) Arm|"Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up.~Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles)."|24 months|All subjects randomized to test (device) arm with 24-month PFO closure assessment|||Participants|||Count of Participants
2769611|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769612|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769613|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769614|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769615|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769616|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769617|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769711|NCT00738894|Secondary|Number of Subjects With Study-related Serious Adverse Events|Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site|24 months|Intention to Treat: all subjects randomized|||Participants|||Count of Participants
2769618|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
2769619|NCT00739960|Secondary|Change From Baseline in 6-minute Walk Distance.||24 weeks and 52 weeks|Data was not collected for this Outcome Measure.||||||
2769620|NCT00739960|Primary|Safety of Abatacept in Progressive Pulmonary Sarcoidosis.|Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.|24 weeks and 52 weeks|Since this study was designed to be a safety study, we chose safety as the primary outcome. Any change of symptoms from baseline was considered possibly related to the study drug, although unlikely. The study was discontinued due to funding withdrawal caused by the principal investigator switching institutions.|||participant adverse events|||Number
2769621|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2769622|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2769623|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2769624|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N=number of participants with analyzable data.|||hours||Full Range|Median
2769625|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2769626|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2769627|NCT00739934|Secondary|Trough Concentrations (Cmin)||Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.|||μg/mL||Standard Deviation|Geometric Mean
2769628|NCT00739934|Secondary|Tmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2769629|NCT00739934|Secondary|Cmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2769630|NCT00739934|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2769631|NCT00739934|Primary|Tmax Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2769632|NCT00739934|Primary|Cmax,ss Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2769633|NCT00739934|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2769634|NCT00739934|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2769636|NCT00739934|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|Intent-to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2769637|NCT00739908|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants|||Number
2769638|NCT00739908|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I)|"The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject's total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants very much improved and much improved at Week 6 or the last available post treatment result (LOCF) is reported here."|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants|||Number
2769639|NCT00739908|Secondary|Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)|IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||units on a scale||95% Confidence Interval|Least Squares Mean
2769640|NCT00739908|Secondary|The Hospital Anxiety and Depression Scale (HADS)|HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||units on a scale||95% Confidence Interval|Least Squares Mean
2769641|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate|Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants||95% Confidence Interval|Number
2769642|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate|MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomization MADRS score.|||percentage of participants||95% Confidence Interval|Number
2769643|NCT00739908|Primary|Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.|Randomization and study end (Week 6).|mITT population consisted of all patients with at least one post randomzation MADRS score. The primary efficacy variable was the change-from-randomization to each available post-randomization measurement of the MADRS total score, used as the response variable in a mixed model repeated measures (MMRM) analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2769644|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
2769645|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
2769661|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment|10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||Participants|||Number
2769646|NCT00739882|Secondary|Proportion of Participants From the Initial Placebo Group Achieving a PGA - H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.|"The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
2769647|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24|"The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
2769648|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12|"The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
2769649|NCT00739882|Primary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12|"The proportion of subjects achieving a PGA - H&F rating of clear, almost clear, or mild at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
2769650|NCT00739765|Secondary|Hamilton Depression Rating Scale|Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores <8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62|After 14 weeks of treatment||||units on a scale||Standard Deviation|Mean
2769651|NCT00739765|Primary|Clinician-Administered PTSD Scale (CAPS)|Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores >50 indicate at least moderately severe PTSD; scores <20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156|After 14 weeks of treatment||||units on a scale||Standard Deviation|Mean
2769652|NCT00739752|Primary|Mean Number of Doses of HBV Vaccine Received|Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.|Day of research visit with 8 month follow-up||||Doses of HBV Vaccine||Standard Deviation|Mean
2769653|NCT00739674|Secondary|Time to Achieve the Target Blood Pressure From Baseline|Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.|||Weeks||95% Confidence Interval|Median
2769654|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
2769655|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
2769656|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
2769657|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
2769658|NCT00739674|Primary|Change in Diastolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
2769659|NCT00739674|Primary|Change in Systolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
2769660|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment|40 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.|||Participants|||Number
2769708|NCT00739024|Primary|T-Test|It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.|4 weeks|||||||
2769662|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment|6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||Participants|||Number
2769663|NCT00739674|Primary|Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||Participants|||Number
2769664|NCT00739661|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death by any cause.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.|||Months||Standard Deviation|Mean
2769665|NCT00739661|Secondary|Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression|Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.|||Months||95% Confidence Interval|Median
2769666|NCT00739661|Primary|Progression-free Survival (PFS)|PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.|||Months||95% Confidence Interval|Median
2769667|NCT00739648|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|The percent change in the amount of air a patient can exhale in 1 second|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT|||Percent||Standard Error|Least Squares Mean
2769668|NCT00739648|Secondary|Percent Change in Forced Vital Capacity (FVC)|The percent change in the amount of air a patient can inhale|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT|||Percent||Standard Error|Least Squares Mean
2769669|NCT00739648|Secondary|Duration of Acute Exacerbation|From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation|from randomization to the patient's final study visit (up to 12 months)|MITT|||Days||Standard Deviation|Mean
2769670|NCT00739648|Primary|Exacerbation Rate|The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.|From randomization to the patients final study visit (up to 12 months)|modified intent to treat (MITT; patients who received at least one dose of study drug)|||exacerbation per patient year||Standard Error|Mean
2769671|NCT00739596|Secondary|Percentage of Participants Achieving BP Control After 8 Weeks of Treatment|To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.|||Cumulative percentage of participants|||Number
2769672|NCT00739596|Secondary|Percentage of Responders After 8 Weeks of Treatment.|To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.|||Cumulative percentage of responders|||Number
2769673|NCT00739596|Secondary|Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment|To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
2769674|NCT00739596|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment|To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
2769675|NCT00739596|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment|To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
2769676|NCT00739583|Secondary|Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification|The number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.|at time of surgery, approximately ten minutes||||sets of intials|Participants||Number
2769677|NCT00739583|Secondary|The Mean Change in Gray Level (Contrast) of the Horizontal Line|The Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).|at time of surgery, approximately ten minutes||||gray level units|Participants|Standard Deviation|Mean
2769678|NCT00739583|Primary|Identification of the Random Initials by the Reviewing Orthopaedic Surgeons|The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.|at time of surgery, approximately 10 minutes||||number of correctly identified initals|Participants||Number
2769679|NCT00739336|Secondary|Questionnaires||baseline, 3, 6, 12 months|||||||
2769680|NCT00739336|Secondary|Waist Circumference||baseline, 3, 6, 12 months|||||||
2769681|NCT00739336|Secondary|Hemoglobin A1c|hemoglobin A1c (%)|baseline||||percent||Standard Deviation|Mean
2769682|NCT00739336|Secondary|Fasting Lipid Profile|LDL-cholesterol (mg/dL)|Baseline||||mg/dL||Standard Deviation|Mean
2769683|NCT00739336|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|Baseline||||mg/dL||Standard Deviation|Mean
2769684|NCT00739336|Primary|Body Weight|Weight loss in kg|3 months|"Participants from the wait-list Control Arm have been combined in the Intervention Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis."|||kg||95% Confidence Interval|Mean
2769685|NCT00739310|Primary|Hospitalizations Lasting at Least 24 Hours in This Patient Population|Hospitalizations lasting at least 24 hours|end of study||||hospitalizations|||Number
2769686|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.|0 (baseline) and 24 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
2769687|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.|0 (baseline) and 8 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
2769688|NCT00739297|Secondary|Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration|FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
2769689|NCT00739297|Primary|Change From Baseline in FEV1 Over 4 Hours|FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|0 (=baseline) to 4 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2769690|NCT00739102|Secondary|Major Adverse Events at 12-month Post Procedure|Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
2769691|NCT00739102|Secondary|Rutherford / Becker Classification Category at 12-month Follow Up||12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
2769709|NCT00738972|Primary|Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients|Left ventricular hypertrophy reduction was to be measured by echocardiography.|6 Month(s)|This study was terminated early and due to sample size it was not possible to perform further statistical analyses.||||||
2769692|NCT00739102|Secondary|Rutherford/Becker Classification at 30-day Follow Up|"The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:~Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease~Stage 1 - Mild claudication~Stage 2 - Moderate claudication~Stage 3 - Severe claudication~Stage 4 - Ischemic rest pain~Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia~Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
2769693|NCT00739102|Secondary|Index Limb Ischemia at 12-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
2769694|NCT00739102|Primary|Primary Safety Endpoint|Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30 days post procedure|||participants|||Number
2769695|NCT00739102|Secondary|Index Limb Ischemia at 6-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|6 months|Active subjects in the Modified ITT population at 6-month post procedure|||participants|||Number
2769696|NCT00739102|Secondary|Stent Fracture at 12-month Follow Up|Stent fracture was assessed by x-ray evaluation.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
2769697|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
2769698|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
2769699|NCT00739102|Secondary|Index Limb Amputation at 30-day Follow up|Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.|30 day|Active subjects in the Modified ITT population at 30 days post procedure|||participants|||Number
2769700|NCT00739102|Secondary|Death at 12-month Post Procedure||12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
2769701|NCT00739102|Secondary|Death Rate at 30-day Post Procedure||30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
2769702|NCT00739102|Primary|12-month Primary Patency Rate|Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.|12 months|As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.|||participants|||Number
2769703|NCT00739063|Primary|Time to Progression (TTP)|Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.|Baseline to disease progression, up to 22 months with follow up.|Study terminated early, unable to complete overall analysis due to insufficient data.|||months|||Number
2769704|NCT00739050|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
2769705|NCT00739050|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
2769706|NCT00739050|Secondary|Change in Total Cholesterol From Baseline at Week 12|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
2769707|NCT00739050|Primary|Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
2769712|NCT00738894|Primary|Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)|"Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days.~An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm."|24 months|Intention to Treat: includes all subjects randomized and evaluated for brain infarct|||Participants|||Count of Participants
2769713|NCT00738894|Primary|Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)|A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.|24 months|Intention to Treat: includes all subjects randomized|||Participants|||Count of Participants
2769714|NCT00738881|Secondary|Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)|Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher's exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.|Up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
2769715|NCT00738881|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.|Time from randomization to time of death from any cause, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
2769716|NCT00738881|Secondary|Time to Treatment Failure|The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.|The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
2769717|NCT00738881|Primary|Progression-free Survival (PFS)|Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.|Time from randomization to the first date of documented disease progression or death, assessed up to 5 years|All the 23 randomized patients are eligible for primary end point analysis using an ITT principle.|||months||95% Confidence Interval|Median
2769718|NCT00738699|Other Pre-specified|Serologic Response Rate|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.||||||
2769719|NCT00738699|Other Pre-specified|Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.||||||
2769720|NCT00738699|Secondary|Time to Tumor Response (TTR)|TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.|Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Months||95% Confidence Interval|Median
2769721|NCT00738699|Secondary|Best Overall Response|BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).|Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Percentage of participants|||Number
2769722|NCT00738699|Primary|Overall Survival (OS)|OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.|Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Months||95% Confidence Interval|Median
2770139|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.|78 weeks|Treated Set with values for AP|||participants|||Number
2769723|NCT00738699|Primary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).|Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.|||Months||95% Confidence Interval|Median
2769724|NCT00738673|Secondary|Kaplan-Meier Estimate for Overall Survival|The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.|up to month 12|"Intent to treat population.~Analysis was not performed since no participants died during study."||||||
2769725|NCT00738673|Secondary|Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study|Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.|up to month 12|Intent to treat population|||participants|||Number
2769726|NCT00738673|Secondary|Participants at Testosterone Level <=0.32 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.|||participants|||Number
2769727|NCT00738673|Secondary|Participants at Testosterone Level <=0.2 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.|||participants|||Number
2769728|NCT00738673|Secondary|Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||IU/L||Standard Deviation|Mean
2769729|NCT00738673|Secondary|Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit|LH is measured in IU/L|Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||percentage of baseline||Standard Deviation|Mean
2769730|NCT00738673|Secondary|Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||ng/mL||Standard Deviation|Mean
2769731|NCT00738673|Secondary|Change From Baseline in Serum Levels of Testosterone at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||ng/mL||Standard Deviation|Mean
2769732|NCT00738673|Secondary|Participants at Testosterone Castrate Level Throughout the Study|Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.|up to month 12|Intent to treat population|||participants|||Number
2769733|NCT00738673|Secondary|Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the two month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 2 months|Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.|||percentage of participants||95% Confidence Interval|Number
2769734|NCT00738673|Secondary|Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the one month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 1 month|Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.|||percentage of participants||95% Confidence Interval|Number
2769735|NCT00738673|Primary|Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level"|Day 0 (baseline), 3 months|Intent to treat population. Last observation carried forward.|||percentage of participants||95% Confidence Interval|Number
2769736|NCT00738543|Secondary|Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period|Presence of allergy or skin reaction at 24 hours after the application of the antiseptic|24 hours||||Number of participants with reaction|||Number
2769737|NCT00738543|Primary|Bacterial Colony Forming Units for the Control Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
2769738|NCT00738543|Primary|Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
2769739|NCT00738543|Secondary|Presence of Skin Reactions for the 10% Povidone-iodine Period|Presence of allergy or any skin reaction at 24 hours after the antiseptic application|24 hours|A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol.|||Number of participants with skin reactio|||Number
2769740|NCT00738543|Primary|Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period|Bacterial colony count of skin cultures to determine antiseptic properties|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
2769761|NCT00738374|Secondary|Duration of Response|The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||days||Standard Error|Mean
2769741|NCT00738530|Secondary|Change From Baseline in Karnofsky Performance Status|Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Week 7, 15, 23, 31, 43|Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.|||score on a scale||Full Range|Median
2769742|NCT00738530|Secondary|Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.|||percentage of participants|||Number
2769743|NCT00738530|Secondary|Percentage of Participants With Objective Response According to mRECIST|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.|||percentage of participants|||Number
2769744|NCT00738530|Secondary|Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to treatment failure was defined as the time between the date of randomization and the date of insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last tumor assessment or last treatment administration, whichever occurred last. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
2769745|NCT00738530|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||percentage of participants|||Number
2769746|NCT00738530|Secondary|Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
2769760|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR/CRi|Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants with a confirmed CR or CRi were included in the analysis.|||participants|||Number
2769747|NCT00738530|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
2769748|NCT00738530|Secondary|Percentage of Participants With Disease Progression or Death|Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||percentage of participants|||Number
2769749|NCT00738530|Primary|Overall Survival (OS) Duration|Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.|Baseline until death (up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
2769750|NCT00738530|Primary|Percentage of Participants Who Died||Baseline up to 4.25 years|ITT population included all participants randomized into the study.|||percentage of participants|||Number
2769751|NCT00738426|Primary|Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.||2 weeks||||participants|||Number
2769752|NCT00738400|Secondary|Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))|Number of participants with no recorded titration of Vardenafil after visit 3.|week 4 and week 8||||Participants|||Number
2769753|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8|Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful ejaculations||95% Confidence Interval|Least Squares Mean
2769754|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8|Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful erections||95% Confidence Interval|Least Squares Mean
2769755|NCT00738400|Secondary|"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"|Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')|up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.|||Percentage of participants|||Number
2769756|NCT00738400|Primary|Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8|Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent erection maintenance||95% Confidence Interval|Least Squares Mean
2769757|NCT00738400|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8|Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful penetrations||95% Confidence Interval|Least Squares Mean
2769758|NCT00738400|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)|The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.|baseline and up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2769759|NCT00738374|Secondary|Disease-Free Survival|The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||days||Standard Error|Mean
2769798|NCT00737737|Secondary|Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?||4 weeks||||ng/ml|||Number
2769762|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR, CRi, or PR|Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||participants|||Number
2769763|NCT00738374|Secondary|OS|The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||Standard Error|Mean
2769764|NCT00738374|Secondary|Number of Participants Who Died|Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
2769765|NCT00738374|Secondary|Time to Next Treatment (TTNT)|The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||Standard Error|Mean
2769766|NCT00738374|Secondary|Number of Participants With New CLL Treatment or Death|Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
2769767|NCT00738374|Secondary|PFS|The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||95% Confidence Interval|Median
2769768|NCT00738374|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
2769769|NCT00738374|Secondary|EFS|The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||95% Confidence Interval|Median
2769770|NCT00738374|Secondary|Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment|Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
2769771|NCT00738374|Secondary|Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study|Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2769772|NCT00738374|Secondary|Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study|Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants, only participants with a confirmed CR were included in the analysis.|||percentage of participants|||Number
2769773|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study|CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.|Month 35|All randomized participants.|||percentage of participants|||Number
2769774|NCT00738374|Secondary|Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment|Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 10|ITT population|||participants|||Number
2769775|NCT00738374|Secondary|Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study|CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 35|All randomized participants who were assessed at Month 35 were included in the analysis.|||percentage of participants|||Number
2769776|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment|CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 10|ITT population|||percentage of participants|||Number
2769777|NCT00738374|Secondary|Percentage of Participants With Documented CR, CRi, or PR at the End of Study|CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL.|Month 35|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2769778|NCT00738374|Primary|Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment|CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL.|Month 10|Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab.|||percentage of participants||95% Confidence Interval|Number
2769779|NCT00738361|Secondary|Overall Survival|Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.|up to 1 year following last treatment, for a total of approximately 5 years||||months||Standard Error|Mean
2769780|NCT00738361|Secondary|Progression-free Survival|Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel|up to 1 year following last treatment, for a total of approximately 5 years|all patients progressed at the time of first scan|||months||95% Confidence Interval|Median
2769781|NCT00738361|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 1 year following last treatment, for a total of approximately 5 years||||patients|||Number
2769782|NCT00738283|Primary|Zinc Absorption|"Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered.~Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption."|96 hours after single feed infusion|Relationships between zinc absorption, zinc excretion (urine or fecal) and zinc balance, and potential explanatory variables were analyzed using the GLM model function of JMP 7 for Macintosh (SAS inc, Cary, NC). Simple and multiple regression analysis were used as appropriate. Significance was assumed at a p < 0.05.|||fractional zinc absorption (%)||Standard Deviation|Mean
2769783|NCT00738062|Secondary|Clinician Rated Clinical Global Impressions - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days||||participants|||Number
2769784|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days||||participants|||Number
2769785|NCT00738062|Secondary|Clinician Recorded Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7)."|14 days||||participants|||Number
2769786|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7). ."|14 days||||participants|||Number
2769787|NCT00738062|Post-Hoc|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients were on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days||||units on a scale||Standard Deviation|Mean
2769788|NCT00738062|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days||||mmHg||Standard Deviation|Mean
2769789|NCT00738062|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score|"The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days||||units on a scale||Standard Deviation|Mean
2769790|NCT00738062|Secondary|Change in Orthostatic Hypotension Daily Activities (OHDAS) Score|"The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|One droxidopa patient excluded from analysis because data were not evaluable.|||units on a scale||Standard Deviation|Mean
2769791|NCT00738062|Primary|Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization."|14 days|"The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study.~One droxidopa patient was excluded from the analysis because OHQ values were not evaluable."|||units on a scale||Standard Deviation|Mean
2769792|NCT00738049|Secondary|Change During Darusentan Treatment in the Coronary Flow Reserve (CFR)|CFR is calculated as the unitless ratio between hyperemic to resting flow|0, 2, 4, and 6 weeks||||no units||Standard Deviation|Mean
2769793|NCT00738049|Secondary|Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia||0, 2, 4, and 6 weeks||||cc/min/gm||Standard Deviation|Mean
2769794|NCT00738049|Primary|Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity|Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from >0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values.|0, 2, 4, and 6 weeks|Statistical analysis is exploratory, therefore not easily planned. A paired t-test with 40 subjects will provide approximately 89% power to test the null hypothesis of no change in the homogeneity number versus a two-sided alternative at alpha= 5%,if the true mean change is 0.15,e.g.,a homogeneity index of 0.5 at baseline and 0.65 after darusentan.|||No units||Standard Deviation|Mean
2769795|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention|Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects|48 hours||||mmHg||Standard Error|Mean
2769796|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Saline Infusions|Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects|48 hours||||mmHg||Standard Error|Mean
2769797|NCT00738023|Primary|Changes in Systolic Blood Pressure During Initial Intralipid Infusion|Systolic blood pressure change from baseline during an 48-hour intralipid infusion|Baseline, 48 hours||||mmHg||Standard Error|Mean
2769800|NCT00737711|Secondary|Mean Serum Alkaline Phosphatase Over Time|Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||U/L||Standard Deviation|Mean
2769801|NCT00737711|Secondary|Mean Alanine Aminotransferase Over Time|Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||U/L||Standard Deviation|Mean
2769802|NCT00737711|Secondary|Mean Aspartate Transaminase Over Time|Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Units/Liter (U/L)||Standard Deviation|Mean
2769803|NCT00737711|Secondary|Mean Serum Bilirubin Over Time|Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
2769804|NCT00737711|Secondary|Mean Serum Phosphate Over Time|Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
2769805|NCT00737711|Secondary|Mean Serum Sodium Over Time|Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mmol/L||Standard Deviation|Mean
2769806|NCT00737711|Secondary|Mean Serum Potassium Over Time|Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2769807|NCT00737711|Secondary|Mean Blood Urea Nitrogen Over Time|Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
2769808|NCT00737711|Secondary|Mean Serum Creatinine Over Time|Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
2769809|NCT00737711|Secondary|Mean Serum Globulin Over Time|Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
2769810|NCT00737711|Secondary|Mean Serum Albumin Over Time|Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
2769811|NCT00737711|Secondary|Mean Transferrin Saturation Over Time|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Percentage of transferrin saturation||Standard Deviation|Mean
2769812|NCT00737711|Secondary|Mean Total Iron-binding Capacity Over Time|Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mcg/dL||Standard Deviation|Mean
2769813|NCT00737711|Secondary|Mean Transferrin Over Time|Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2769814|NCT00737711|Secondary|Mean Serum Ferritin Over Time|Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||nanogram /milliliter (ng/mL)||Standard Deviation|Mean
2769815|NCT00737711|Secondary|Mean Serum Iron Over Time|Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||microgram/deciliter (mcg/dL)||Standard Deviation|Mean
2769816|NCT00737711|Secondary|Mean Platelet Count Over Time|Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
2769817|NCT00737711|Secondary|Mean Hypochromic Red Blood Cells Over Time|Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
2769818|NCT00737711|Secondary|Mean Value of Mean Corpuscular Volume Over Time|Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Femtoliter||Standard Deviation|Mean
2769819|NCT00737711|Secondary|Mean White Blood Cell Count Over Time|The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
2769820|NCT00737711|Secondary|Number of Participants With Reports of Anti-Epoetin Antibodies|Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug.|||Participants|||Number
2769821|NCT00737711|Secondary|Number of Participants With Reports of Blood Transfusions|Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.|||Participants|||Number
2769822|NCT00737711|Secondary|Number of Participants With Abnormal Electrocardiogram|Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.|Up to Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Participants|||Number
2769823|NCT00737711|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 18|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.|||Participants|||Number
2769824|NCT00737711|Secondary|Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2769825|NCT00737711|Secondary|Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||Weeks||Standard Deviation|Mean
2769826|NCT00737711|Secondary|Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter|Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.|Up to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||Weeks||Standard Deviation|Mean
2769827|NCT00737711|Primary|Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period|The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.|Baseline (Week 0) and Week 16|The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||gram/deciliter (g/dL)||Standard Deviation|Mean
2769828|NCT00737698|Primary|Quadriceps Fibre Size of Type IIa Fibres|Quadriceps fibre cross-sectional area type II a fibres in quadriceps fibre.|8 weeks|Per protocol analysis|||micrometers squared||Inter-Quartile Range|Median
2769829|NCT00737672|Secondary|Procedural Success|Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.|Following Index Procedure||||Participants|||Number
2769830|NCT00737672|Secondary|Anatomic Success|Less than 30 percent residual stenosis following study treatment (Index Procedure).|Index Procedure||||Participants|||Number
2769831|NCT00737672|Secondary|Clinical Success|The resumption of normal dialysis for at least one session following study treatment (Index Procedure).|Following Index Procedure||||Participants|||Number
2769832|NCT00737672|Secondary|Circuit Primary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769833|NCT00737672|Secondary|Circuit Primary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769834|NCT00737672|Secondary|Circuit Primary Patency|"Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.~P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve."|6 months||||Percentage of Subjects||95% Confidence Interval|Number
2769835|NCT00737672|Primary|Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure|The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.|30 days||||Participants|||Number
2769836|NCT00737672|Primary|Target Lesion Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~P-Value calculated from 24-month data cohort after study completion."|24 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769837|NCT00737672|Secondary|Access Secondary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769838|NCT00737672|Secondary|Access Secondary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769839|NCT00737672|Secondary|Access Secondary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Six-month estimate of secondary access patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769840|NCT00737672|Secondary|Assisted Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769841|NCT00737672|Secondary|Assisted Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769842|NCT00737672|Secondary|Assisted Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Six-month estimate of assisted primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769843|NCT00737672|Primary|Target Lesion Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|12 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769844|NCT00737672|Primary|Target Lesion Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
2769849|NCT00737568|Secondary|Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.|||percentage change||Standard Deviation|Mean
2769850|NCT00737568|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.|||percentage change||Standard Deviation|Mean
2769851|NCT00737568|Secondary|Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240|The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.|||percentage of participants|||Number
2769852|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240|The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
2769853|NCT00737568|Secondary|Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
2769854|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.|||percentage of participants|||Number
2769855|NCT00737568|Secondary|Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.|||percentage of participants|||Number
2769856|NCT00737568|Secondary|Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240|Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
2769857|NCT00737568|Secondary|HBV DNA Level at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
2769858|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
2769859|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240||Weeks 48, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
2769860|NCT00737568|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
2769861|NCT00737529|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)|The safety population received at least one dose of lenalidomide was used for all safety analysis. This was identical to the ITT population.|||participants|||Number
2769862|NCT00737529|Secondary|Overall Survival (OS)|Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.|From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months|Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2769872|NCT00737477|Secondary|Percentage of Participants Requiring Blood Transfusions|The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.|Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants|||Number
2769863|NCT00737529|Secondary|Time to Complete Response (CR+CRu) According to the Independent Review Committee|Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.|From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days|Included participants from the ITT population who achieved a CRu or better.|||months||Full Range|Median
2769864|NCT00737529|Secondary|Time to Response (TTR)|Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.|From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days|Included participants from the ITT population who achieved a PR or better.|||months||Full Range|Median
2769865|NCT00737529|Secondary|Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee|Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.|From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days|Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2769866|NCT00737529|Secondary|Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee|Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir|From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months|Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2769867|NCT00737529|Secondary|Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee|Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months|Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2769868|NCT00737529|Secondary|Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee|Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.|From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months|Includes participants from the ITT population who achieved a CRu or better.|||months||95% Confidence Interval|Median
2769869|NCT00737529|Secondary|Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee|The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow.|From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days|The ITT population was defined as all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2769870|NCT00737529|Primary|Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee|Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.|From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.|Includes participants from the ITT population who achieved a PR or better.|||months||95% Confidence Interval|Median
2769871|NCT00737529|Primary|Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.|From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.|ITT population defined as all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2769873|NCT00737477|Secondary|Percent Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."|||percent change in dose||Standard Deviation|Mean
2769874|NCT00737477|Secondary|Absolute Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."|||mcg||Standard Deviation|Mean
2769875|NCT00737477|Secondary|Number of Dose Adjustments of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."|||dose adjustments||Standard Deviation|Mean
2769876|NCT00737477|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table."|||percentage of participants|||Number
2769877|NCT00737477|Secondary|Percentage of Participants With Down Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one down excursion."|||percentage of participants|||Number
2769878|NCT00737477|Secondary|Percentage of Participants With Up Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one up excursion."|||percentage of participants|||Number
2769879|NCT00737477|Secondary|Percentage of Participants With Cycles or Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated."|Weeks 4 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants|||Number
2769880|NCT00737477|Secondary|Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.|Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table."|||percentage of participants|||Number
2769881|NCT00737477|Secondary|Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.|Weeks 16 to 24 and Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."|||weeks||Standard Deviation|Mean
2769882|NCT00737477|Secondary|Change in Hb Value From Baseline to the EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|Baseline and Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||g/dL||Standard Deviation|Mean
2769883|NCT00737477|Secondary|Percentage of Participants With Hb Values Within Target Range During the EEP|During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table."|||percentage of participants|||Number
2769884|NCT00737477|Primary|Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants||95% Confidence Interval|Number
2769885|NCT00737464|Secondary|Mean Values of Serum Sodium and Serum Potassium Over Time|Mean values of serum sodium and serum potassium were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||millimole per liter||Standard Deviation|Mean
2769886|NCT00737464|Secondary|Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time|Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||miligram per deciliter||Standard Deviation|Mean
2769887|NCT00737464|Secondary|Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time|Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||units per litre||Standard Deviation|Mean
2769888|NCT00737464|Secondary|Mean Values of Serum Albumin and Serum Globulin Over Time|Mean values of serum albumin and serum globulin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||gram per deciliter||Standard Deviation|Mean
2769889|NCT00737464|Secondary|Mean Values of Transferrin Saturation Over Time|Mean values of Transferrin Saturation (TSAT) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Percentage||Standard Deviation|Mean
2769890|NCT00737464|Secondary|Mean Values of Transferrin Over Time|Mean values of transferrin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||miligram per mililiter||Standard Deviation|Mean
2769891|NCT00737464|Secondary|Mean Values of Serum Ferritin Over Time|Mean values of serum ferritin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||nanogram per mililiter||Standard Deviation|Mean
2769892|NCT00737464|Secondary|Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time|Mean values of serum iron and total iron binding capacity (TIBC) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||microgram per deciliter||Standard Deviation|Mean
2769893|NCT00737464|Secondary|Mean Corpuscular Volume Levels Over Time|Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||femtoliters||Standard Deviation|Mean
2769894|NCT00737464|Secondary|Mean Values of Hypochromic Red Blood Cells Over Time|Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Percentage of RBCs||Standard Deviation|Mean
2769895|NCT00737464|Secondary|Mean Values of White Blood Cells and Platelets Over Time|Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Per cubic millimeter||Standard Deviation|Mean
2769896|NCT00737464|Secondary|Number of Participants With Abnormal Electrocardiogram|Participants with abnormal electrocardiogram were reported.|At Week -2 and Week 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.|||Number of participants|||Number
2769939|NCT00737061|Secondary|Patient Satisfaction With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.|48 hours|Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.|||percentage of participants|||Number
2769897|NCT00737464|Secondary|Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time|Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.|From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.|||mmHg||Standard Deviation|Mean
2769898|NCT00737464|Secondary|Mean Change From Baseline in Heart Rate Over Time|Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.|From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Beats per minute (bpm)||Standard Deviation|Mean
2769899|NCT00737464|Secondary|Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths|Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|Safety population included all enrolled participants who received at least one dose of study drug.|||Number of participants|||Number
2769900|NCT00737464|Secondary|Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL|Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.|Up to Week 12|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||Weeks||Standard Deviation|Mean
2769901|NCT00737464|Secondary|Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)|The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||gm/dL||Standard Deviation|Mean
2769902|NCT00737464|Primary|Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)|Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|Weeks 8 to 12 (Last 4 weeks of treatment period)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||Percentage of participants||95% Confidence Interval|Number
2769903|NCT00737438|Primary|Overall Response Will be Characterized by the Patient's FDG-PET Scan|A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline.|2 years||||participants|||Number
2769904|NCT00737360|Secondary|Safety|Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.|Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.|All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.|||number of participants|||Number
2769905|NCT00737360|Secondary|Overall Survival|Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.|12 months after enrollment of the last patient||||day||95% Confidence Interval|Median
2769906|NCT00737360|Secondary|Antitumor Activity|"Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR., or similar text that was as accurate and appropriate."|Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.|Antitumor activity was the rate of best overall objective responses(complete response + partial response).|||participants|||Number
2769907|NCT00737360|Primary|Progression Free Survival(PFS)|PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.|From the date of registration until the earliest date of documented disease progression, death, or censoring event.|One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.|||day||95% Confidence Interval|Median
2769908|NCT00737282|Primary|To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)||12 months|Study prematurely terminated||||||
2769938|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.|||percentage of participants|||Number
2769909|NCT00737243|Secondary|Number of Participants With a Tissue of Origin Successfully Predicted by the Assay|To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.|at baseline|Of 252 participants analyzed, the assay correctly predicted the tissue of origin in 247 patients (98%). The predicted tissue of origin could not be determined in 5 participants (2%).|||participants|||Number
2769910|NCT00737243|Primary|Overall Survival|Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.|every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months|Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.|||months||95% Confidence Interval|Median
2769911|NCT00737204|Secondary|HIV Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Log10 copies/mL||Standard Deviation|Mean
2769912|NCT00737204|Secondary|CD4 Cell Count|Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Cells/mcL||Standard Deviation|Mean
2769913|NCT00737204|Primary|Role Function Scale|The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.|Measured at Baseline and Week 4|The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
2769914|NCT00737204|Primary|Fatigue Severity Scale(FSS) Outcome|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.|Measured at baseline and Weeks 4|Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).|||units on a scale||Standard Deviation|Mean
2769915|NCT00737178|Primary|Use of the IUD for Contraception at Six Months|Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).|6 months||||participants|||Number
2769916|NCT00737178|Secondary|Expulsion and Removal Rates|"Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.~Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study."|Within six months of medication abortion|Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion|||participants|||Number
2769917|NCT00737178|Secondary|Insertion Rates|Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.|By six months after medication abortion||||participants|||Number
2769918|NCT00737100|Secondary|Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation|Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.|From first drug administration until 30 days after last drug administration (up to 121 days)|Treated set|||participants|||Number
2769919|NCT00737100|Secondary|Time From Dosing to the Maximum Concentration (Tmax,ss)|Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||h||Full Range|Median
2769920|NCT00737100|Secondary|Maximum Measured Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2769921|NCT00737100|Secondary|Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)|Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||ng||Geometric Coefficient of Variation|Geometric Mean
2769922|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Parent Questionnaire|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
2769923|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adolescents Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
2769924|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adult Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
2769925|NCT00737100|Secondary|Respiratory and Systemic Symptoms Questionnaire (RSSQ)|Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Participants|||Number
2769926|NCT00737100|Secondary|Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12|Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
2769927|NCT00737100|Secondary|Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12|Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
2769928|NCT00737100|Secondary|Percent Predicted FVC Trough Response at the End of Week 12|Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
2769929|NCT00737100|Secondary|Percent Predicted FVC AUC0-4 Response at the End of Week 12|Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
2769930|NCT00737100|Primary|Percent Predicted FEV1 Trough Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
2769931|NCT00737100|Primary|Percent Predicted FEV1 AUC0-4 Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
2769932|NCT00737061|Secondary|3 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.|3 years|Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.|||percentage of participants|||Number
2769933|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.|||percentage of participants|||Number
2769934|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.|||percentage of participants|||Number
2769935|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.|48 hours|Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.|||percentage of participants|||Number
2769936|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.|Post-Procedure|Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.|||percentage of participants|||Number
2769937|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.|||percentage of participants|||Number
2769940|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|Including Second Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.|||percentage of participants|||Number
2769941|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|After First Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.|||percentage of participants|||Number
2769942|NCT00737061|Primary|1 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.|1 year|645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.|||percentage of participants|||Number
2769943|NCT00737048|Secondary|Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain|"Percentage of participants were assessed with treatment response based on evaluation criteria for efficacy of analgesics in post-tooth-extraction pain for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as very effective, effective, somewhat effective and ineffective for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as extremely useful, useful, not useful & could not be assessed for overall evaluation (OE)."|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
2769944|NCT00737048|Secondary|Number of Participants Treated With a Relief Analgesic|Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Participants|||Number
2769945|NCT00737048|Secondary|Percentage of Participants With Categorical Score for Patient Impressions|Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Percentage of participants|||Number
2769946|NCT00737048|Secondary|Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy|Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Minutes||Standard Deviation|Mean
2769947|NCT00737048|Secondary|Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769948|NCT00737048|Secondary|Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769949|NCT00737048|Secondary|Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment|The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769950|NCT00737048|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769951|NCT00737048|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)|The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769952|NCT00737048|Secondary|Sum of Pain Intensity Difference (SPID)|Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769953|NCT00737048|Secondary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769954|NCT00737048|Primary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|8 hours|Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
2769955|NCT00736996|Secondary|Change in Peak Oxygen Uptake (VO2 Peak)|Peak oxygen consumption (VO2 peak, ml/kg/min) was determined by open circuit spirometry during a standard treadmill stress test (modified Balke protocol).|Baseline to 6 months||||ml/kg/min||95% Confidence Interval|Number
2769956|NCT00736996|Secondary|Change in Insulin Resistance|Change in whole body glucose disposal rate (mg/kg/min) calculated during a single-stage (40 mU/m2/min), 3-hour hyperinsulinemic, euglycemic clamp|Baseline to 6 months||||mg/kg/min||95% Confidence Interval|Number
2769957|NCT00736996|Primary|Change in Cognitive Performance|Participants were administered a neuropsychological testing battery consisting of assessments in four cognitive domains: memory (Visual Reproduction II, Logical Memory II, Rey Auditory Verbal Learning Test), language (Boston Naming Test , Category Fluency), visuospatial (Block Design, Picture Completion), and executive function (Trail Making Test B, Digit Symbol Test). Raw test scores for these primary cognitive domain measures were transformed into age-adjusted scaled scores with a mean of 10 and a standard deviation (SD) of 3, with higher numbers indicating better cognitive performance, using the Mayo's Older American Normative Studies data. Cognitive domain scores were calculated as the arithmetic mean of the normatively derived scaled scores for all of the tests in that domain.|Baseline to 6 months||||units on a scale||95% Confidence Interval|Number
2769958|NCT00736957|Secondary|Change From Baseline in Short Form-36 (SF-36) Score|SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.|Baseline, Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.|||units on a scale||Standard Deviation|Mean
2769959|NCT00736957|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4|PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on scale||Standard Deviation|Mean
2769960|NCT00736957|Secondary|Pain Relief (PAR) Score at Week 4|Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2769961|NCT00736957|Secondary|Pain Intensity Difference (PID) at Week 4|PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2770137|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for LDH|||participants|||Number
2769962|NCT00736957|Secondary|Number of Participants With Improvement From Baseline in VAS24 Score|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.|||participants|||Number
2769963|NCT00736957|Primary|Change From Baseline in VAS24 Score at Week 52|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.|||millimeter||Standard Deviation|Mean
2769964|NCT00736957|Primary|Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4|Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.|||millimeter||Standard Deviation|Mean
2769965|NCT00736944|Secondary|Progression-free Survival|Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
2769966|NCT00736944|Secondary|Disease Free Survival|Time from complete response to death from any cause, to disease progression or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
2769967|NCT00736944|Secondary|Overall Survival|Time from diagnosis to death or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
2769968|NCT00736944|Secondary|Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis||completion of the first 10 patients induction chemotherapy||||participants|||Number
2769969|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.|||participants|||Number
2769970|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.|||participants|||Number
2769971|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.|||participants|||Number
2769972|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.|||participants|||Number
2769973|NCT00736944|Secondary|Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage.|||percentage of participants|||Number
2769974|NCT00736944|Secondary|Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease.|||percentage of participants|||Number
2769985|NCT00736944|Primary|Clinical Complete Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size."|post-2 cycles of induction (approximately 42 days from start of treatment)|All patients who completed 2 cycles of induction therapy.|||participants|||Number
2770138|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Albumin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.|78 weeks|Treated Set with values for Albumin|||participants|||Number
2769975|NCT00736944|Secondary|Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|"In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests.~We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease.|||percentage of participants|||Number
2769976|NCT00736944|Secondary|Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion.|||participants|||Number
2769977|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST.|||participants|||Number
2769978|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline.|||participants|||Number
2769979|NCT00736944|Other Pre-specified|Overall Complete and Partial Response Rates by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan.|||participants|||Number
2769980|NCT00736944|Secondary|Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured.|||participants|||Number
2769981|NCT00736944|Secondary|Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan.|||participants|||Number
2769982|NCT00736944|Secondary|Clinical Overall Complete and Partial Response Rates|"Clinical exam included laryngoscopy in office or operating room.~Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days)||||participants|||Number
2769983|NCT00736944|Secondary|Clinical Complete and Partial Response Rates to the Involved Regional Nodes|"Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam.|||participants|||Number
2769984|NCT00736944|Secondary|Clinical Partial Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Partial response rate (PR) defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Participants who completed 2 cycles of induction therapy|||participants|||Number
2770021|NCT00736840|Secondary|AUC of ROC (Area Under Receiver Operating Characteristic Curve)|The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.|At study day 1 after 1 hour test||||Probability||95% Confidence Interval|Mean
2769986|NCT00736879|Secondary|Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants|Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.|Baseline to Week 24/end of treatment plus 4 days|N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.|||participants|||Number
2769987|NCT00736879|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants|12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.|||participants|||Number
2769988|NCT00736879|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants|Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||bpm||Standard Error|Mean
2769989|NCT00736879|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants|Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.|||mmHg||Standard Error|Mean
2769990|NCT00736879|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.|||participants|||Number
2769991|NCT00736879|Secondary|Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.|||participants|||Number
2769992|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants|Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||cm||Standard Error|Mean
2769993|NCT00736879|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Baseline (Day 1), Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.|||Adjusted Percentage of participants|||Number
2769994|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants|Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
2769995|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
2769996|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||kg||Standard Error|Mean
2769997|NCT00736879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants|Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||Percent Hemoglobin||Standard Error|Mean
2769998|NCT00736853|Secondary|Change From Baseline in SF-36 at Day 28 of Double-Blind Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2769999|NCT00736853|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770000|NCT00736853|Secondary|Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770001|NCT00736853|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770002|NCT00736853|Secondary|Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770003|NCT00736853|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770004|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770005|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.|Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
2770006|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Double-Blind Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770007|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Open-Label Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1 and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
2770008|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770009|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, and Day 8 of open-label period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770042|NCT00736489|Secondary|Palpitations, Average Effect Over 0 - 4 h Post-dose|Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
2770010|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770011|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
2770012|NCT00736853|Secondary|Mean PAR Score During the Double-Blind Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770013|NCT00736853|Secondary|Mean Pain Relief (PAR) Score During the Open-Label Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770014|NCT00736853|Secondary|Mean PID During the Double-Blind Period|The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770015|NCT00736853|Secondary|Mean Pain Intensity Difference (PID) During the Open-Label Period|The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770016|NCT00736853|Secondary|Mean PI Score During Double-Blind Period|The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2770017|NCT00736853|Secondary|Mean Pain Intensity (PI) Score During Open-Label Period|PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
2770018|NCT00736853|Secondary|Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.|||mm||Standard Deviation|Mean
2770019|NCT00736853|Secondary|Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 of open-label period and Day 1 of double-blind period|Efficacy analysis set included participants who received at least one dose of study drug.|||mm||Standard Deviation|Mean
2770020|NCT00736853|Primary|Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period|The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.|Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.|||number of participants|||Number
2770123|NCT00736099|Secondary|Change in FPG From Baseline to Week 42||Baseline and week 42|Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770022|NCT00736840|Primary|"Number of Subjects With Likelihood of Cirrhosis Based on Hepatic Impairment Score (HIS)"|"Hepatic Impairment Score (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard."|Study day 1 after a 1 hour test|The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis.|||Participants|||Number
2770023|NCT00736723|Primary|Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes|maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock|01 July 2008 to 31 Dec 2008||||pg/ml||Full Range|Median
2770024|NCT00736645|Secondary|Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction|Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C.|1 year|All treated and eligible patients|||percentage of apoptotic cells||Full Range|Median
2770025|NCT00736645|Primary|Effects of Selenium and Finasteride and Their Combination on PSA Level|Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.|1 year|All treated and eligible patients|||ng/mL||Full Range|Median
2770026|NCT00736632|Secondary|Urine Calcium to Creatinine Ratio.|Urine calcium to creatinine ratio assessed by spectrophotometry|0, 2 and 4 Months|1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.|||mg/gm||Standard Deviation|Mean
2770027|NCT00736632|Secondary|Fasting Glucose|Serum fasting glucose assessed by hexokinase method|0, 2, and 4 Month|1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.|||mg/dL||Standard Deviation|Mean
2770028|NCT00736632|Secondary|hsCRP|High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay|0, 2, and 4 Month|Several subjects were unable to give a sample at various time points.|||mg/L||Standard Deviation|Mean
2770029|NCT00736632|Secondary|Vitamin D|25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry|0, 2, and 4 Month||||pg/mL||Standard Deviation|Mean
2770030|NCT00736632|Secondary|HbA1C|HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood|0, 2, and 4 month|1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.|||percentage||Standard Deviation|Mean
2770031|NCT00736632|Secondary|Serum Calcium|Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA|0, 2, and 4 Month|1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.|||mg/dL||Standard Deviation|Mean
2770032|NCT00736632|Secondary|Macrophage Cholesterol Metabolism|Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.|0 and 4 months|This analysis was only performed in a subset of patients.|||unitless (ratio)||Standard Deviation|Mean
2770033|NCT00736632|Secondary|Brachial Artery Reactivity Testing|Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline.|0, 2, and 4 months|Some patients were unable to obtain adequate ultrasound images for BART analysis or did not show up for some visits|||percentage of dilation||Standard Deviation|Mean
2770034|NCT00736632|Primary|Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)|24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.|0, 2, and 4 months|Occasional patients had missing blood pressure data or dropped out of the study prior to completion.|||mm Hg||Standard Deviation|Mean
2770035|NCT00736580|Secondary|Surgeon Satisfaction by Likert Scale.||1 week|||||||
2770036|NCT00736580|Primary|Surgical Glove Perforation.|Direct measurement of the number of glove perforations listed by surgical case.|1 week||||Cases with a glove puncture|||Number
2770037|NCT00736502|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Calculated as CD4+ cell count at week 48 minus the baseline value|Baseline and week 48|TS with non-missing data at baseline and week 48|||Cells/mm^3||Standard Deviation|Mean
2770038|NCT00736502|Secondary|Virologic Response (VR)|VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.|48 weeks|TS|||Participants|||Number
2770039|NCT00736502|Primary|Proportion of Patients Reporting Adverse Events|the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.|48 weeks|The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.|||Percentage of participants|||Number
2770040|NCT00736489|Secondary|Plasma AZD3199 AUC0-24|Area under the plasma concentration curve from time 0 to 24 h post-dose|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.|||nmol*h/L||Full Range|Geometric Mean
2770041|NCT00736489|Secondary|Plasma AZD3199 Cmax|Maximum plasma concentration of AZD3199 measured|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.|||nmol/L||Full Range|Geometric Mean
2770124|NCT00736099|Secondary|Change in FPG From Baseline to Week 30||Baseline and week 30|Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770043|NCT00736489|Secondary|Palpitations, Peak Effect Over 0 - 4 h Post-dose|Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
2770044|NCT00736489|Secondary|Tremor, Average Effect Over 0 - 4 h Post-dose|Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
2770045|NCT00736489|Secondary|Tremor, Peak Effect Over 0 - 4 h Post-dose|Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
2770046|NCT00736489|Secondary|QTcB, Average Effect Over 0 - 4 h Post-dose|Average QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||ms||Standard Deviation|Mean
2770047|NCT00736489|Secondary|QTcB, Peak Effect Over 0 - 4 h Post-dose|Maximum QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||ms||Standard Deviation|Mean
2770048|NCT00736489|Secondary|Heart Rate, Average Effect Over 0 - 4 h Post-dose|Average heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
2770049|NCT00736489|Secondary|Heart Rate, Peak Effect Over 0 - 4 h Post-dose|Maximum heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
2770050|NCT00736489|Secondary|Pulse, Average Effect Over 0 - 4 h Post-dose|Average pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
2770051|NCT00736489|Secondary|Pulse, Peak Effect Over 0 - 4 h Post-dose|Maximum pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
2770052|NCT00736489|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
2770053|NCT00736489|Secondary|Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Minimum DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
2770054|NCT00736489|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
2770055|NCT00736489|Secondary|Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Maximum SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
2770056|NCT00736489|Secondary|FEV1 Average Effect Over 12 - 24 h Post-dose|FEV1 average effect over 12 h night-time period|12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
2770057|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 12 h Post-dose|FEV1 average effect over 12 h day-time period|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
2770058|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 24 h Post-dose|FEV1 average effect over 24 h dosing interval|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
2770059|NCT00736489|Secondary|FEV1 Effect at 5 Min Post-dose|FEV1 at 5 minutes|5min|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on Placebo and 1 on AZD3199 480 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
2770060|NCT00736489|Primary|S-potassium, Average Effect Over 0 - 4 h Post-dose|Average S-potassium concentration|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||mmol/L||Standard Deviation|Mean
2770061|NCT00736489|Primary|S-potassium, Peak Effect Over 0 - 4 h Post-dose|Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||mmol/L||Standard Deviation|Mean
2770062|NCT00736489|Primary|E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.|Residual FEV1 24 h post-dose|22- 26 h post dose|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
2770063|NCT00736489|Primary|FEV1 Peak Effect Within 0 - 24 h Post-dose|Maximum FEV1 value|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
2770064|NCT00736476|Secondary|Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)|The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response.|12 weeks post HP challenge|Per-protocol dataset|||Stimulation Index (SI)||Standard Deviation|Mean
2770065|NCT00736476|Secondary|Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge|The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR.|12 weeks post HP challenge|Per-protocol dataset|||percentage of T-cells||Standard Deviation|Mean
2770066|NCT00736476|Secondary|Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups.|12 months|Per-protocol dataset|||μg/mL||95% Confidence Interval|Geometric Mean
2770067|NCT00736476|Secondary|The Geometric Mean Concentrations After HP Vaccination.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported.|upto 1 month after 3rd vaccination|Per-Protocol dataset|||μg/mL||95% Confidence Interval|Geometric Mean
2770068|NCT00736476|Secondary|The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups|The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests.|12 months||||Participants|||Number
2770069|NCT00736476|Primary|Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination|To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events.|Day 1-7 post vaccination|This analysis was done on the safety dataset|||Participants|||Number
2770070|NCT00736476|Primary|The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.|"The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo).~Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT)."|12 weeks post HP challenge|Per-protocol dataset|||Percentage of subjects|||Number
2770071|NCT00736450|Secondary|Efficacy of Treatment, in Terms of Complete Response Rate (Anyone Achieving a CR or Cru)|Response criteria are the recommendations of the International Harmonization Project's update to the International Working Group guidelines. Complete response (CR) is defined as disappearance of all evidence of disease; Partial response (PR) is defined as regression of measurable disease and no new sites|End of treatment, an average of 4 months||||Participants|||Count of Participants
2770072|NCT00736450|Primary|Number of Participants With Microarray Testing Results Are Completed Within 7 Days.||Upto 7 days||||Participants|||Count of Participants
2770073|NCT00736450|Primary|Time to Perform Microarray Study After Receipt of Tissue|The time from tissue harvest to release of microarray test and IHC assay results will be noted in days.|Upto 14 days||||days||Full Range|Mean
2770074|NCT00736385|Secondary|Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
2770075|NCT00736385|Secondary|Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
2770076|NCT00736385|Secondary|Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
2770077|NCT00736385|Primary|Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
2770078|NCT00736333|Primary|Number of Times Premedications Were Given for Prevention of PPE|Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.|Day 1 up to 24 weeks|Safety population (those who received at least one dose of study medication)|||Number of times premedication was given|||Number
2770079|NCT00736333|Primary|Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)|PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.|Up to 24 weeks|Safety population (those who received at least one dose of study medication)|||Occurrences|||Number
2770080|NCT00736333|Primary|Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR|Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.|Cycles 1 & 3 (Week 4 & Week 12)|Safety population (those who received at least one dose of study medication)|||Participants|||Number
2770081|NCT00736333|Primary|Percent of Participants Taking Premedication for Prevention of IR|Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.|Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin|Safety population (those who received at least one dose of study medication)|||Percent of participants|||Number
2770082|NCT00736333|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|CR and PR were documented according to the clinical standards of each site.|Day 1 up to 24 weeks|Intent-to-treat (those who received at least one dose of study medication)|||Participants|||Number
2770083|NCT00736333|Primary|Number of Participants With Infusion Reactions (IR)|Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.|Day 1 up to Week 24|Safety population (those who received at least one dose of study medication)|||Participants|||Number
2770084|NCT00736255|Secondary|Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. 1-Very Much Improved through 7-Very Much Worse.|Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)||||score on a scale||Standard Deviation|Mean
2770085|NCT00736255|Secondary|N-back Test Proportion Correct Across 4 Load Factors|This is measured by the N-Back test, a cognitive functioning, including working memory test. The test is designed with 4 Load Factors, where the current stimulus matches the one from 'n' steps back or prior in the sequence. The load factor n is adjusted so there is a 'O-back' (i.e. 'n-0'), '1-back' (i.e. 'n-1'), '2-back' (i.e. 'n-2'), and '3-back' (i.e. 'n-3'). When the correct stimulus appears on the screen, the participant then responds on the computer. Missing the stimulus decreases the proportion correct.|Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||proportion correct to stimuli response||Standard Deviation|Mean
2770086|NCT00736255|Secondary|ADHD Conners' Adult ADHD Rating Scales (CAARS) Self-Report and Observer Short Forms|"T-scores derived from compiled ADHD symptoms from two forms. Specifically the t-scores for the DSM-IV Total subscale, representing ADHD symptoms. This is conducted by the participant and clinician at randomization, visits 2 and 4 (i.e. dose titration visits), Visit 6 (i.e. monitoring visit), and Visit 8 (i.e. final/end of study visit).~The following describes severity of the ADHD symptoms (based upon T-Score):~70+ = Very Much Above Average 66-70 = Much Above Average 61-65 = Above Average 56-60 = Slightly Above Average 45-55 = Average 30-44 = Below Average (Low scores are good)"|Randomization, Visits 2 (day 7), 4 (day 14), 6 (day 21), 8 (day 28)||||T-score on a scale||Standard Deviation|Mean
2770087|NCT00736255|Secondary|Continuous Performance Test (CPT) Reaction Time Standard Error|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||Reaction time in seconds||Standard Deviation|Mean
2770088|NCT00736255|Secondary|Continuous Performance Test (CPT) Commission Errors|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors - measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, Visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||Errors of Commission||Standard Deviation|Mean
2770089|NCT00736255|Secondary|Smoking Rates|Smoking rates, measured as self-reported cigarettes/day.|Randomization, visits 1 (day 4), 2 (day 7), 3 (day 11), 4 (day 14), 5 (day 18), 6 (day 21), 7 (day 25), 8 (day 28)||||Cigarettes smoked per day||Standard Error|Mean
2770090|NCT00736255|Primary|The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels <= 4 Ppm for Each Post-quit Study Visit.|The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels <= 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.|4 weeks|Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels <= 4ppm for each post quit study visit were analyzed for the outcome measure.|||participants|||Number
2770091|NCT00736242|Secondary|Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment|"An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a~congenital anomaly or birth defect."|From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).|Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.|||participants|||Number
2770125|NCT00736099|Secondary|Change in FPG From Baseline to Week 18||Baseline and week 18|Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770092|NCT00736242|Secondary|Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment|The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.|From the Baseline Visit up to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.|||cells/μL||Full Range|Median
2770093|NCT00736242|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.~HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing"|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.|||participants|||Number
2770094|NCT00736242|Secondary|Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).~HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing."|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.|||participants|||Number
2770095|NCT00736242|Secondary|Participant Study Status at End of Follow-up (EOF)|"Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.~SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT."|From EOT to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.|||participants|||Number
2770096|NCT00736242|Secondary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as undetectable serum HCV-RNA at week 12 and/or a~≥2 log decline in HCV-RNA levels at week 12 from baseline."|From Treatment Week 1 to Treatment Week 12|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.|||participants|||Number
2770097|NCT00736242|Secondary|Number of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable serum HCV-RNA at week 4.|At Treatment Week 4|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4|||participants|||Number
2770098|NCT00736242|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).|From End of Treatment to 24 weeks post-treatment (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus [HIV] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.|||participants|||Number
2770099|NCT00736229|Secondary|Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)||30 days||||participants|||Number
2770100|NCT00736229|Secondary|Rates of Hypoglycemia and Severe Hypoglycemia|Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl)|1-48 hours||||participants|||Number
2770101|NCT00736229|Primary|Time to Steady State|Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl.|Start of infusion through 48 hours or until discharge||||hours||Inter-Quartile Range|Median
2770102|NCT00736229|Primary|Median Glucose Values From Steady State Through 48 Hours or Until Discharge.|Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.|1-48 hours|Intention to treat|||mg/dL||Inter-Quartile Range|Median
2770103|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Who Discontinued the Study Early|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, discontinued TDF treatment after Week 24 with HBV DNA >= 400 copies/mL, and had serum sample for testing.|||Participants|||Number
2770104|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants With Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).|||Participants|||Number
2770126|NCT00736099|Secondary|Change in FPG From Baseline to Week 6||Baseline and week 6|Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770127|NCT00736099|Secondary|Number of Patients With Lowered HbA1c by at Least 0.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||participants|||Number
2770105|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Without Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|10 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and did not have virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).|||Participants|||Number
2770106|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||2099-01-31|01/2099||||
2770107|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||2099-01-31|01/2099||||
2770108|NCT00736190|Secondary|Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48|Blood samples from study participants were collected for measuring HBV DNA via PCR method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
2770109|NCT00736190|Secondary|Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion|HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48.|Week 48||||Participants|||Number
2770110|NCT00736190|Secondary|Change From Baseline in FibroTest Value|The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant's age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline and Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Scores on a scale||Standard Deviation|Mean
2770111|NCT00736190|Secondary|Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48|Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
2770112|NCT00736190|Secondary|Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48|A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L)|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study, received at least one dose of study drug, and had baseline ALT > ULN (34 U/L).|||participants|||Number
2770113|NCT00736190|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48|Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
2770114|NCT00736190|Primary|Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)|Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
2770115|NCT00736125|Other Pre-specified|Changes in Neurocognitive Tests Following Surgery|"Hopkins Verbal Learning Test (HVLT).This is a test of verbal learning and memory.~The scale is the number of words retained. The total score for the test administered ranges from 0 to 12. Higher values represent better outcomes."|3 months following surgery||||score on a scale||Standard Error|Mean
2770116|NCT00736125|Secondary|Number of Patients With Delirium During Hospital Stay||First 3 days after surgery||||Participants|||Count of Participants
2770117|NCT00736125|Secondary|Number of Patients With Emboli in the High Category||During surgery||||Patients w/ emboli in high category|||Number
2770118|NCT00736125|Primary|The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)||During surgery||||emboli|||Number
2770119|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Cholesterol|||participants|||Number
2770120|NCT00736099|Secondary|Change in FPG From Baseline to Week 78||Baseline and week 78|Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770121|NCT00736099|Secondary|Change in FPG From Baseline to Week 66||Baseline and week 66|Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770122|NCT00736099|Secondary|Change in FPG From Baseline to Week 54||Baseline and week 54|Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
2770140|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.|78 weeks|Treated Set with values for Bilirubin|||participants|||Number
2770141|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Glucose|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.|78 weeks|Treated Set with values for Glucose|||participants|||Number
2770142|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for AST|||participants|||Number
2770143|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for ALT|||participants|||Number
2770144|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Sodium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).|78 weeks|Treated Set with values for Sodium|||participants|||Number
2770145|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Calcium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).|78 weeks|Treated Set with values for Calcium|||participants|||Number
2770146|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Phosphate|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).|78 weeks|Treated Set with values for Phosphate|||participants|||Number
2770147|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for Creatinine kinase|||participants|||Number
2770148|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.|78 weeks|Treated Set with values for Creatinine|||Participants|||Number
2770149|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for GGT|||Participants|||Number
2770150|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Amylase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).|78 weeks|Treated Set with values for Amylase|||Participants|||Number
2770151|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Triglycerides|||Participants|||Number
2770152|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.|78 weeks|Treated Set with values for Uric acid|||Participants|||Number
2770153|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Potassium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).|78 weeks|Treated Set with values for Potassium|||participants|||Number
2770154|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Platelets|For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).|78 weeks|Treated Set with values for Platelets|||Participants|||Number
2770155|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: White Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).|78 weeks|Treated Set with values for White blood cell count|||Participants|||Number
2770156|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Red Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.|78 weeks|Treated Set with values for Red blood cell count|||Participants|||Number
2770157|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haematocrit|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.|78 weeks|Treated Set with values for Haematocrit|||Participants|||Number
2770158|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haemoglobin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.|78 weeks|Treated Set with values for Haemoglobin|||Participants|||Number
2770159|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Eosinophils|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.|78 weeks|Treated Set with values for Eosinophils|||participants|||Number
2770160|NCT00736099|Primary|Number of Patients With Abnormalities in Vital Signs|Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
2770161|NCT00736099|Primary|Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events|Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)|78 weeks|Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug|||participants|||Number
2770162|NCT00736099|Primary|Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)|As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
2770163|NCT00736099|Primary|Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events||78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
2770164|NCT00736099|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
2770165|NCT00736073|Secondary|Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis||7 days||||participants|||Number
2770166|NCT00736073|Secondary|Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis||48 hours post ERCP and 1 week post ERCP|There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls & lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.||||||
2770167|NCT00736073|Primary|Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).||48 hours|The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.|||cases of ERCP in participants|||Number
2770168|NCT00736034|Secondary|Clinical Global Impression of Change (CGI-C)Scale|"The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change. Global improvement score ranges from 1 = Very much improved, through 4 = No change, to 7 = Very much worse. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period."|15 weeks|||||||
2770169|NCT00736034|Primary|Change From Baseline in Neuropsychological Computerized Test|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|baseline, 15 weeks||||Points on a scale||Standard Deviation|Mean
2770170|NCT00735969|Primary|Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.||24 weeks after treatment stop||||participants|||Number
2770171|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
2770172|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
2770173|NCT00735943|Secondary|Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy|VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient's VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
2770174|NCT00735943|Secondary|Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen|Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
2770196|NCT00735878|Primary|The Median Survival in the Study Population|Median overall survival using the Kaplan Meier method|from the start of the study until the last subject dies (up to 100 weeks)|12 Participants were enrolled into the phase 1 portion of the tiral and later 8 more patients were enrolled for a total of 20 analyzed patients.|||months||95% Confidence Interval|Median
2770840|NCT00732940|Secondary|Median Percent Change From Baseline in Anti-dsDNA at Week 24||Baseline, 24 weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770175|NCT00735943|Secondary|Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA|FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
2770176|NCT00735943|Secondary|Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|"Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first stabilization in VA (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up."|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||injections||Full Range|Median
2770177|NCT00735943|Secondary|Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|"Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first stabilization in VA (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up."|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||injections|||Number
2770178|NCT00735943|Secondary|Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA|Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
2770179|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters|A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.|12 months or last follow-up visit before study termination|Due to small sample size, the analysis was not conducted.|||Percentage of participants|||Number
2770180|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique.|||Percentage of participants|||Number
2770181|NCT00735943|Secondary|Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy|Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF analysis.|||Percentage of participants|||Number
2770182|NCT00735943|Primary|Median Number of Injections to Achieve Stabilization of VA|"Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first stabilization in VA (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up."|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.|||injections||Full Range|Median
2770183|NCT00735943|Primary|Average Number of Injections to Achieve Stabilization of VA|"Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first stabilization in VA (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up."|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.|||injections||Standard Deviation|Mean
2770211|NCT00735787|Secondary|Number of Subjects With PASI 90|Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
2774740|NCT00708071|Secondary|Resolution of Ecchymosis as Assessed by Investigators|Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
2770184|NCT00735943|Primary|Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)|VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.|Baseline through 12 months or last follow-up visit before study termination|Full Analysis Set (FAS) included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by Last Observation Carried Forward (LOCF) technique.|||percentage of participants|||Number
2770185|NCT00735917|Secondary|Progression-Free Survival|Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.|Progression and survival status assessed every month, up to 2 years||||months||95% Confidence Interval|Median
2770186|NCT00735917|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.|From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years|No patients qualified for a confirmed response and therefore this endpoint was not analyzed.||||||
2770187|NCT00735917|Secondary|Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])|"A confirmed tumor response is defined to be a CR or PR noted as > the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) > > Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters. >~> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters."|Evaluated using the first 6 courses of treatment||||participants|||Number
2770188|NCT00735917|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Up to 2 years||||months||95% Confidence Interval|Median
2770189|NCT00735917|Primary|Six Month Survival|The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.|Up to 6 months||||percentage of patients||95% Confidence Interval|Number
2770190|NCT00735904|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
2770191|NCT00735904|Secondary|Progression Free Survival (PFS)|"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
2770192|NCT00735904|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
2770193|NCT00735904|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2770194|NCT00735878|Secondary|Number of Patients With Buccal Cells Demonstrating a Decline in Cyclin D1|Cyclin D1 levels were evaluated by immunoblot analyses of pretreatment (day 0) and paired posttreatment (day 4, 8 and 22) buccal swabs.|pretreatment (Day 0) and patient paired post- treatment (Days 4,8, 22) buccal swabs.|A subset of patients treated at the recommended Phase II dose from Phase II/Group 2|||participants|||Number
2770195|NCT00735878|Secondary|Pharmacokinetic Profile of ABT-751 for Phase 2|The pharmacokinetic profile of ABT-751 given in combination with carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.|Randomization to maximum tolerated dose confirmed|Data were not collected. The PK analysis was not performed at the request of financial sponsor.||||||
2770271|NCT00735475|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|Abbreviation UAE stands for Unsolicited Adverse Event.|21 days after vaccination||||participants|||Number
2770197|NCT00735878|Primary|Objective Response Rate of Participants Using A Combination of ABT-751 and Carboplatin|The effectiveness of the combination with ABT-751 and carboplatin in patients with advanced NSCLC as measured by objective response rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), The disappearance of all known disease determined by two observations not less than four weeks apart.; Partial Response (PR), At least a 30% or more decrease in total tumor load of the lesions that have been measured to determine the effect of therapy by two observations not less than four weeks apart.; Overall Response (OR) = CR + PR|42 days (end of cycle 2)||||Participants|||Count of Participants
2770198|NCT00735878|Primary|Maximum Tolerated Dose (MTD) of ABT-751 in Combination With Carboplatin|The maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose Carboplatin AUC 6 in patients with advanced non small cell lung cancer (NSCLC). Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Gr 2 toxicity, additional 2 patients will be enrolled at the dose level. If 1 of the 3 patients experience a Gr 3 toxicity or higher the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without a Gr 2 toxicity, enrollment in the next cohort (dose level 2) can begin. The rapid dose escalation scheme will apply to cohorts 1 through 3.|21 Days (end of cycle 1)||||mg of ABT-751|||Number
2770199|NCT00735839|Primary|Number of Participants With Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.|Baseline (Day 1) to Day 84 postvaccination||||Participants|||Number
2770200|NCT00735839|Primary|Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level|Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.|Baseline (Day 1) to Day 14 postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2770201|NCT00735826|Secondary|Effects of Vorinostat Treatment on Induction of Apoptosis or Necrosis in Treated vs. Untreated Tumors|vorinostat's effects on induction of apoptosis or necrosis in treated vs untreated tumors and on p21, p27, EGFR, and phospho-EGFR expression aerodigestive tract tumors. Immunohistochemical score is defined as follows: 0, no tumor cells staining positive; 1+, 0% to 50% of tumor cells staining positive; 2+, 50% to 75% of tumor cells staining positive; and 3+, 75% to 100% of tumor cells staining positive.|Baseline to day 7||||score on a scale||95% Confidence Interval|Mean
2770202|NCT00735826|Secondary|Concentration of Vorinostat in Tumor Tissue|Concentration of vorinostat in tumor tissue will be measured after 7 days of use of Vorinostat.|Day 7 from Baseline||||ng/mg||95% Confidence Interval|Median
2770203|NCT00735826|Primary|Changes in Tumor Markers on Tumors of the Lung, Esophagus, or Head and Neck, After 7 Days of Treatment With Vorinostat|Immunohistochemical score, defined as: 0, no tumor cells staining positive; 1+, 0% to 50% of tumor cells staining positive; 2+, 50% to 75% of tumor cells staining positive; and 3+, 75% to 100% of tumor cells staining positive. The change in the score before and after treatment is percentage - 0-100|Baseline to Day 7|Participants who had at least two days days of treatment with vorinostat.|||percentage of change||95% Confidence Interval|Median
2770204|NCT00735787|Secondary|Number of Subjects With Difficulties According to PHQ-9|Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).|Baseline and Weeks 2, 8, 16, and 28|"Analysis was based on the ITT subject population. Missing values were imputed as extremely difficult."|||subjects|||Number
2770205|NCT00735787|Secondary|Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)|The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
2770206|NCT00735787|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)|WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).|Baseline and Weeks 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
2770207|NCT00735787|Secondary|Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain|On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using LOCF.|||mm on scale||Standard Deviation|Mean
2770208|NCT00735787|Secondary|Number of Subjects Achieving a DLQI of 0|Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
2770209|NCT00735787|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
2770210|NCT00735787|Secondary|Number of Subjects With PASI 100|Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
2770272|NCT00735475|Secondary|Duration of Local and Systemic Solicited Symptoms||5 days after vaccination||||Days||Standard Deviation|Mean
2770212|NCT00735787|Secondary|Number of Subjects With PASI 75|Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
2770213|NCT00735787|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50|Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
2770214|NCT00735787|Secondary|Number of Subjects With PGA of Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
2770215|NCT00735787|Secondary|Number of Subjects With PGA of Clear or Almost Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
2770216|NCT00735787|Secondary|Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
2770217|NCT00735787|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).|Baseline and Weeks 8, 16, and 28|Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.|||units on a scale||Standard Deviation|Mean
2770218|NCT00735787|Secondary|Number of Subjects With Marked Improvement in ESIF From Baseline|Number of subjects that achieved > 75% reduction from Baseline in ESIF|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
2770219|NCT00735787|Secondary|Number of Subjects With Moderate Improvement in ESIF From Baseline|Number of subjects that achieved > 50% reduction from Baseline in ESIF.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
2770220|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Soles|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using the LOCF method.|||units on a scale||Standard Deviation|Mean
2770221|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Palms|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using the LOCF method.|||units on a scale||Standard Deviation|Mean
2770222|NCT00735787|Secondary|Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2770223|NCT00735787|Primary|Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Week 16|Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.|||subjects|||Number
2770224|NCT00735709|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
2770273|NCT00735475|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms||5 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||Percentage of Participants|||Number
2770225|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770226|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770227|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2 and 4|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770228|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770229|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770230|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770231|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770232|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770841|NCT00732940|Secondary|Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24||Baseline, 24 Weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.|||IU/mL||Standard Error|Mean
2770233|NCT00735709|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis|Baseline and Weeks 1, 4, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770234|NCT00735709|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770235|NCT00735709|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770236|NCT00735709|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770237|NCT00735709|Secondary|Percentage of Participants With a Sustained Response in HAM-D24 Total Score|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|From Baseline through Week 8|Full analysis set|||percentage of participants|||Number
2770238|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Other Weeks Assessed|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Weeks 1, 2, 4 and 6|Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.|||percentage of participants|||Number
2770239|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770240|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2770241|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770242|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2 and 6|"Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770243|NCT00735709|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770244|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
2770245|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770246|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Week 8|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Week 8|Full analysis set; last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2770247|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770248|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770274|NCT00735475|Primary|Percentage of Participants With Seroconversion 21 Days After the Study Vaccination|Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.|||Percentage of participants||95% Confidence Interval|Number
2770249|NCT00735709|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8|The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770250|NCT00735696|Secondary|Maximum Concentration of Ramucirumab (Cmax)||Week 18 (Cycle 6), at 1-Hour Post End of Infusion|Participants who received any quantity of study medication and had evaluable concentration data at the specified time point.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
2770251|NCT00735696|Secondary|Serum Anti-Ramucirumab Antibody Assessment|The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.|Week 15 (Cycle 5)|Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5).|||participants|||Number
2770252|NCT00735696|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.|First dose to death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Fourteen participants were censored."|||months||95% Confidence Interval|Median
2770253|NCT00735696|Secondary|Progression-free Survival (PFS)|"Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause.~Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy."|First dose to measured progressive disease or death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."|||months||95% Confidence Interval|Median
2770254|NCT00735696|Secondary|Overall Survival (OS) at 1 Year|Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.|First dose to 1 year|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2770255|NCT00735696|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.|First dose up to 32.5 months|Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis.|||months||95% Confidence Interval|Median
2770256|NCT00735696|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])|Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|First dose to measured progressive disease or death due to any cause up to 32.5 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2770257|NCT00735696|Secondary|Summary of Participants Reporting Adverse Events|Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Baseline up to 32.5 months|Safety Population: All participants who received any quantity of study drug.|||participants|||Number
2770258|NCT00735696|Primary|Percentage of Participants Who Are Progression-free (PFS) at 6 Months|Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|6 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."|||percentage of participants||95% Confidence Interval|Number
2770275|NCT00735475|Primary|Geometric Mean Titer 21 Days After the Study Vaccination||21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.|||Titers||95% Confidence Interval|Geometric Mean
2770309|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 8 of treatment|5 subjects with missing values|||mm (on a scale)||Standard Deviation|Mean
2776328|NCT00697593|Primary|Biochemistry - Alanine Transaminase (ALT)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||IU/L||Standard Deviation|Mean
2770259|NCT00735670|Secondary|Depression Scale of the Patient Health Questionnaire (PHQ-9)|The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.|Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks|Subjects with PHQ-9 data at any of the measurement time points (baseline, weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks) are included in the means reported for each time point. The sample size for each time point is given in the category title (e.g., 10Ven = 10 venlafaxine group or 11Plac = 11 placebo group) if it deviates from baseline.|||units on a scale||Standard Deviation|Mean
2770260|NCT00735670|Primary|16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)|The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a >50% change in scores on the QIDs from baseline to week 13 (end of treatment period).|Baseline and Week 13|Participants who completed the week 13 assessment.|||participants|||Number
2770261|NCT00735644|Other Pre-specified|Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.|Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.|||Participants|||Number
2770262|NCT00735644|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.|Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.|||Participants|||Number
2770263|NCT00735644|Secondary|Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine|Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2770264|NCT00735644|Secondary|Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Participants|||Number
2770265|NCT00735644|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV|Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2770266|NCT00735644|Primary|Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Participants|||Number
2770267|NCT00735618|Primary|Differences Between Pre/Post ESAS Score|Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.|Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)|Analysis included all study participants.|||units on a scale||Standard Deviation|Mean
2770268|NCT00735553|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated||||||
2770269|NCT00735475|Secondary|New Onsets of Chronic Illness|A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||participants|||Number
2770270|NCT00735475|Secondary|Serious Adverse Events||180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||participants|||Number
2770276|NCT00735462|Secondary|Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period|"Treatment related defined as probably related or related by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.~Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction."|Up to 16 weeks|Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.|||participants|||Number
2770277|NCT00735462|Primary|Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.|The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.|Up to 16 weeks||||proportion of participants||95% Confidence Interval|Number
2770278|NCT00735449|Secondary|Number of Subjects With Adverse Events|Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).|Week 12|Safety population, which included all patients who started the study (randomized) and were treated.|||Participants|||Number
2770279|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 6|Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2770280|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 12|Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2770281|NCT00735449|Primary|Mean Intraocular Pressure (IOP) at 10 AM at Week 12|Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2770282|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 10 AM at Week 6|Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2770283|NCT00735436|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities|47 months|intent-to-treat|||participants|||Number
2770284|NCT00735436|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage|Incidence and severity of CNS hemorrhage|47 months|intent-to-treat|||participants|||Number
2770285|NCT00735436|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause, assessed up to 47 months|intent-to-treat|||months||95% Confidence Interval|Median
2770286|NCT00735436|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 47 months|intent-to-treat|||months||95% Confidence Interval|Median
2770287|NCT00735436|Secondary|24-week Progression-free Survival (PFS)|The percentage of participants surviving 24 weeks from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|24 weeks|intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2770288|NCT00735436|Primary|24-week Overall Survival|The percentage of participants surviving 24 weeks from the start of study treatment|24 weeks|intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2770289|NCT00735397|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.|||Percent responders|||Number
2770307|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 4 of treatment|5 subjects with missing values|||participants|||Number
2770308|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 12 of treatment|Intention to treat population|||mm (on a scale)||Standard Deviation|Mean
2770290|NCT00735397|Secondary|Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.|||Percent change||Full Range|Median
2770291|NCT00735397|Primary|Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.|The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.|||participants|||Number
2770292|NCT00735371|Secondary|Youth Quality of Life-Research Version (YQOL-R) Total Score|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 4 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2770293|NCT00735371|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|1, 2, 3 and 4 Weeks|FAS|||Participants|||Number
2770294|NCT00735371|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3 and 4 weeks|Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)|||Units on a scale||Standard Error|Least Squares Mean
2770295|NCT00735306|Secondary|One Year Overall Survival From Time of Diagnosis|One year survival from time of diagnosis for patients who completed this regimen|1 year||||participants|||Number
2770296|NCT00735306|Secondary|Number of Dose Limiting Toxicities||Within 30 days of completing radiation||||Events|||Number
2770297|NCT00735306|Primary|Tarceva Maximum Tolerated Dose in mg|Tarceva maximum tolerated dose in mg|1 yr||||mg|||Number
2770298|NCT00735254|Primary|Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar|The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.|1 year|study was not conducted per protocol, data was not collected, study terminated. Reported to IRB and closed study.||||||
2770299|NCT00735072|Primary|Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)||Week 24||||%CD38+ HLA-DR+ CD8+ T cells||Inter-Quartile Range|Median
2770300|NCT00735072|Secondary|Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)||Week 24|||||||
2770301|NCT00735072|Secondary|Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)||Week 24|||||||
2770302|NCT00735072|Secondary|Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)||Week 24|||||||
2770303|NCT00735072|Secondary|Change in CD4+ T Cell Count||Week 24|||||||
2770304|NCT00735007|Secondary|The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.|Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section|at the end of weeks 4, 8, and 12 of treatment|||||||
2770305|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 12 of treatment|Intention to treat population|||participants|||Number
2770306|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 8 of treatment|5 subjects with missing values|||participants|||Number
2770310|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 4 of treatment|4 subjects with missing values|||mm (on a scale)||Standard Deviation|Mean
2770311|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 12 of treatment|21 subjects with missing values|||participants|||Number
2770312|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 8 of treatment|21 subjects with missing values|||participants|||Number
2770313|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 4 of treatment|21 subjects with missing values|||participants|||Number
2770314|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770315|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 8 of treatment|5 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770316|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770317|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770318|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770319|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770320|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770321|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770322|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770323|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770324|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770325|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
2770350|NCT00734903|Secondary|Addiction Severity Index Employment Composite|Employment problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770326|NCT00735007|Primary|The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).|"RebiSmart was evaluated as very suitable or suitable; a little suitable; or not suitable at all for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer."|End of 12 week treatment period|4 subjects with missing values|||participants|||Number
2770327|NCT00734994|Primary|Safety and Tolerability|Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.|During Treatment Phase average 6 weeks||||Grade 1/2 event count (no grade 3+)|Participants||Number
2770328|NCT00734994|Secondary|Median Recurrence Free-survival|Time to first recurrence of cancer in the bladder.|Median follow-up 3.18 years|Entire cohort|||Months||95% Confidence Interval|Median
2770329|NCT00734968|Primary|Incidence of Post-operative UTI in Treatment Group|The incidence of UTI in the nitrofurantoin group was 17.6%.|6 weeks||||participants|||Number
2770330|NCT00734968|Primary|Incidence of Post-operative UTI in Placebo Group|The incidence of UTI in the placebo group was 32%.|6 weeks||||participants|||Number
2770331|NCT00734968|Primary|Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence|The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)|6 weeks||||participants|||Number
2770332|NCT00734929|Secondary|"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"|Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)|48 hour||||participants|||Number
2770333|NCT00734929|Secondary|Time to First Vomiting||48 h|The analysis population only includes participants who had vomiting and had a complete data set|||hours||Inter-Quartile Range|Median
2770334|NCT00734929|Secondary|Number of Vomiting Episodes||48 hours||||vomiting episodes||Inter-Quartile Range|Mean
2770335|NCT00734929|Secondary|Average Nausea Score|Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable|Post OP hours 0-2, 24 h, 48 h||||units on a scale||Inter-Quartile Range|Mean
2770336|NCT00734929|Secondary|Number of Participants With a Complete Response Rate|complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.|24 hours Post OP, 48 hours Post OP||||participants|||Number
2770337|NCT00734929|Secondary|Use of Rescue Antiemetics (48 Hours)||48 hour||||participants|||Number
2770338|NCT00734929|Secondary|Use of Rescue Antiemetics (24 Hours)||24 h||||participants|||Number
2770339|NCT00734929|Secondary|Use of Rescue Antiemetics (Post OP)||Post OP (0 - 2 hours)||||participants|||Number
2770340|NCT00734929|Secondary|Incidence of Vomiting (24 Hours)|Any vomiting or retching|24 h|ITT analysis|||participants|||Number
2770341|NCT00734929|Secondary|Incidence of Vomiting (Post OP)||Post OP (0 - 2 hours)||||participants|||Number
2770342|NCT00734929|Secondary|Incidence of Nausea|operative procedure|Post operative procedure (OP) hours (0-2, 24, 48)||||participants|||Number
2770343|NCT00734929|Primary|Cumulative Incidence of Emesis|Any vomiting or retching|48 h|ITT analysis|||participants|||Number
2770344|NCT00734903|Secondary|Alcoholics Anonymous (AA) Intention Measure|Self-reported attitudes toward attending 12-step meetings; a scale of 17 items, each rated 1 (extremely unlikely) to 7 (extremely likely). The mean across all items thus ranges from 1 to 7 with with more positive scores indicating a more positive attitude toward 12-step meetings.|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770345|NCT00734903|Secondary|Coping Skills Measure|Self-report measure of confidence in ability to cope comprising 18 items, each scaled from 0 (not at all) to 5 (extremely). The mean across all 18 items ranges from 0 to 5 with higher scores indicating less pathology (i.e., stronger ability to cope).|Baseline, end of treatment, 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770346|NCT00734903|Secondary|BASIS-24 Psychosocial Functioning|24 items that address how patients feel before and after receiving care. The survey measures the degree of difficulty experienced by the patient during a one-week period on a five-point scale ranging from 0 (no difficulty) to extreme difficulty (4) with the overall score ranging from 0-96.|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770347|NCT00734903|Secondary|Global Severity Index of the Brief Symptom Inventory|Self-report measure of severity of general psychiatric symptoms ranging from 0 (not at all) to 4 (extremely). The total scale score Global severity index (GSI) is the mean of all 53 items on the measures. The mean ranges from 0 to 4, with higher indicating worse pathology.|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770348|NCT00734903|Secondary|Addiction Severity Index Family/Social Composite|Family/social problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770349|NCT00734903|Secondary|Addiction Severity Index Psychiatric Composite|Psychiatric problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770351|NCT00734903|Secondary|Addiction Severity Index Medical Composite Score|Medical problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770352|NCT00734903|Primary|Brief Addiction Monitor|Assesses number of days in the past 30 days that person used substances including alcohol and drugs|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||days out of past 30 days||Standard Deviation|Mean
2770353|NCT00734903|Primary|Addiction Severity Index Drug Composite|Drug use and associated problems as measured by blinded-interviewer rated composite score. Urinalysis/breathalyzer is also obtained to verify self-report.Drug use and associated problems as measured by blinded-interviewer rated composite score. Eleven questions comprise the drug composite, of which 9 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Urinanalysis was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).|Baseline, end of treatment (3 months), and 3-month post-treatment followup||||units on a scale||Standard Deviation|Mean
2770354|NCT00734903|Primary|Addiction Severity Index Alcohol Composite|Alcohol use and associated problems as measured by blinded-interviewer rated composite score. Six questions comprise the alcohol composite, of which 4 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Breathalyzer was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).|Baseline, end of treatment (month 3), 3-month post-treatment follow-up||||units on a scale||Standard Deviation|Mean
2770355|NCT00734851|Secondary|Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.|Prospective collection of prostate tissue at the time of radical prostatectomy is routinely performed at Duke. These samples will be analyzed by laser capture microdissection (LCM) for genomic profiling by RNA expression analysis for all subjects with tissue available. The expression profiles of subjects who experience PSA recurrence after protocol therapy by the 24 month endpoint will be compared with the expression profiles of subjects without recurrence at this time point as an exploratory measure to predict aggressive prostate cancer and those subjects who are unlikely to benefit from this approach. Baseline prostate tumor biomarkers in the form of RNA expression profiles will be correlated with 2 year PFS in an exploratory analysis. The median bPFS of those with detectable biomarker expression is reported.|2 and 3 years|Due to the unavailability of tissue, this outcome was not performed.||||||
2770356|NCT00734851|Secondary|Change in Quality of Life (QoL) After 3 Month|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline and 3 months after completing radiotherapy. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 3 months|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.|||units on a scale||Full Range|Median
2770357|NCT00734851|Secondary|Change in Quality of Life (QoL) After 1 Year|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline, at 3 months after completing radiotherapy, at 12 months, and at 2 and 3 years of follow-up for a total of 5 possible surveys per patient. Due to a low number of completed surveys at the fourth and fifth time point, the difference between the 12 month time point and baseline is summarized. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 1 year|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.|||units on a scale||Full Range|Median
2770358|NCT00734851|Secondary|Metastasis-free Survival (MFS) Rates at 2 and 3 Years.|MFS is defined as the length of time between the date of start of treatment and the date of evidence of systemic disease on bone scan or cross sectional imaging or death, whichever occurs first.|2 and 3 years|This rate is not estimable as 0 patients had locally recurrent disease before being taken off study for biochemical progression.||||||
2770359|NCT00734851|Secondary|Rate of Local Recurrence at 2 and 3 Years|Local recurrence is defined as men with locally recurrent disease confirmed pathologically within the radiation field, and is estimated at 2 and 3 years.|24 months and 36 months||||percentage of participants|||Number
2770360|NCT00734851|Secondary|Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.|Percentage of participants surviving 24 and 36 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount or a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks. Please note: bPFS is identical to PFS but includes only PSA-based endpoints or death.|24 months and 36 months||||percentage of patients||95% Confidence Interval|Number
2770361|NCT00734851|Primary|The Rate of Progression Free Survival (PFS) at 24 Months|Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.|2 years||||percentage of patients||95% Confidence Interval|Number
2770362|NCT00734799|Secondary|Nightmare Frequency|Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.|12 weeks after Baseline||||Nightmare frequency per night||Standard Error|Mean
2770363|NCT00734799|Primary|Insomnia Severity|Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.|12-weeks after Baseline|Intent to treat and completed were both reported. Data on completers reported here.|||ISI Score||Standard Error|Mean
2770364|NCT00734747|Secondary|Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject||6 months|Note: 1 of the 66 participants was not taking proton pump inhibitors (PPIs) at baseline, therefore they were excluded from the analysis of PPI use reduction.|||percentage of subjects||95% Confidence Interval|Number
2770365|NCT00734747|Secondary|Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test|Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure|6 months||||percentage of time pH <4.0||Standard Deviation|Mean
2770366|NCT00734747|Primary|Serious Adverse Events (SAEs)|"The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. Treatment-related events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients."|6 months||||participants|||Number
2770367|NCT00734747|Primary|Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score|Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement >= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval)|Six months||||percentage of total participants||95% Confidence Interval|Number
2770368|NCT00734734|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0 to 3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.|||Number of participants|||Number
2770369|NCT00734734|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
2770370|NCT00734734|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
2770384|NCT00734604|Secondary|Number of Participants With at Least One Serious Adverse Event|Serious adverse events are listed in the Reported Adverse Event module.|baseline through 26 weeks (including two washout periods of 1 week each)||||participants|||Number
2770385|NCT00734604|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint|EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770371|NCT00734734|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2770372|NCT00734656|Secondary|Change in Serum 3a-androstanediol Glucuronide|Ratio of serum 3a-androstanediol drawn prior to alcohol administration (2-4 days after medication administration) compared to the baseline level prior to medication dose. The pharmacologic effect of dutasteride was measured by assay of serum 5a-androstan-3a,17b-diol,17-glucuronide (aka 3a-androstanediol glucuronide) as a biochemical measure of 5a-reductase enzyme inhibition. 3a-androstanediol glucuronide is the primary metabolic excretion product of 3a,5a-androstane neuroactive steroids. The|Baseline (pre medication administration) and 2-4 days post-medication (alcohol session)|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||ratio||Standard Error|Mean
2770373|NCT00734656|Primary|BAES Stimulation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES)Simulation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 stimulation related questions regarding effects of alcohol. Total BAES stimulation subscale score 0-70 with higher numbers indicating greater stimulating effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||units on a scale||Standard Error|Mean
2770374|NCT00734656|Primary|BAES Sedation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score 0-70 with higher numbers indicating greater sedative effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||units on a scale||Standard Error|Mean
2770375|NCT00734656|Primary|Breath Alcohol|Breath Alcohol level|40 minutes after beginning drink|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||gr/dL||Standard Error|Mean
2770376|NCT00734630|Secondary|Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)||||mmHG||Standard Deviation|Mean
2770377|NCT00734630|Primary|Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)||||mmHG||Standard Deviation|Mean
2770378|NCT00734617|Primary|Continuous Abstinence From Smoking at Ten Weeks Post-quit|Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.|May 2009||||participants|||Number
2770379|NCT00734604|Secondary|"Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 4 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770380|NCT00734604|Secondary|"Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 3 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770381|NCT00734604|Secondary|"Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 2 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770382|NCT00734604|Secondary|"Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 1 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770383|NCT00734604|Secondary|Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770386|NCT00734604|Secondary|Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770387|NCT00734604|Secondary|Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770388|NCT00734604|Secondary|Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection||baseline, 8 weeks of each treatment||||proportion of days||Standard Deviation|Mean
2770389|NCT00734604|Secondary|Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770390|NCT00734604|Secondary|Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770391|NCT00734604|Secondary|Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770392|NCT00734604|Secondary|Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770393|NCT00734604|Primary|Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
2770394|NCT00734591|Secondary|Rate of Primary Lung Cancer Diagnosis|The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population|||Lung Cancer per 1000 PY||95% Confidence Interval|Number
2770395|NCT00734591|Secondary|Rate of All-cause Mortality|The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population|||Deaths per 1000 PY||95% Confidence Interval|Number
2770396|NCT00734591|Secondary|Rate of Primary Lung Cancer Mortality Among Former Smokers|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Subset of the entire study population who were former smokers.|||Deaths per 1000 PY||95% Confidence Interval|Number
2770397|NCT00734591|Primary|Rate of Primary Lung Cancer Mortality|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population: all randomized participants (retrospective).|||Deaths per 1000 patient years (PY)||95% Confidence Interval|Number
2770398|NCT00734578|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
2770399|NCT00734578|Secondary|Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF|This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2770842|NCT00732940|Secondary|Median Percent Change From Baseline in Complement C4 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770400|NCT00734578|Secondary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2770401|NCT00734578|Secondary|Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and week 8|FAS|||Percent of participants|||Number
2770402|NCT00734578|Secondary|Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2770403|NCT00734578|Secondary|Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2770404|NCT00734578|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
2770405|NCT00734578|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
2770406|NCT00734578|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and weekly up to 8 weeks|Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.|||Units on a scale||Standard Deviation|Mean
2770407|NCT00734539|Secondary|Intraventricular Hemorrhage|Grade 3 or 4|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770408|NCT00734539|Secondary|Positive Bacterial Infection From a Sterile Site||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770409|NCT00734539|Secondary|Length of Hospitalization||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||days||Inter-Quartile Range|Median
2770410|NCT00734539|Secondary|Retinopathy of Prematurity Requiring Laser Surgery||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770411|NCT00734539|Secondary|Periventricular Leukomalacia||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770412|NCT00734539|Secondary|Patent Ductus Arterious Requiring Surgical Ligation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770413|NCT00734539|Secondary|Chronic Lung Disease||36 weeks corrected gestational age|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770414|NCT00734539|Secondary|Focal Intestinal Perforation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770415|NCT00734539|Secondary|Stage II or Higher Necrotizing Enterocolitis||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770416|NCT00734539|Secondary|Candidiasis|Definite or probable|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770417|NCT00734539|Secondary|Neurodevelopmental Impairment|Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy|18-22 months corrected gestational age|Attended the follow-up visit and had complete data on composite endpoint|||participants|||Number
2770418|NCT00734539|Primary|Death or Candidiasis|"The primary endpoint for the study is death or candidiasis.~Death prior to study day 49.~Candidiasis prior to study day 49~Definite: isolation of Candida from normally sterile body fluid (blood, CSF, urine [obtained via sterile catheterization or suprapubic tap], peritoneal fluid).~Probable:~i. > 5 days of consecutive antifungal therapy~AND both:~ii. Thrombocytopenia <150,000/mm3 iii. Positive Candida culture from nonsterile site (ETS, bag urine)"|study day 49|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
2770419|NCT00734500|Secondary|Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.|During and up to 10 days after last dose of study drug.||||participants|||Number
2770420|NCT00734500|Primary|The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Area under the curve at steady state|5 days||||µg*h/mL||Full Range|Median
2770843|NCT00732940|Secondary|Absolute Change From Baseline in Complement C4 at Week 24||Baseline, 24 weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.|||mg/dL||Standard Error|Mean
2770421|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks|Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.|||participants|||Number
2770422|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Pancreatitis at 104 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.|||participants|||Number
2770423|NCT00734474|Secondary|Antibodies to LY2189265|The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.|Baseline through 104 weeks|All randomized participants in the LY2189265 arms who had evaluable ADA data. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
2770424|NCT00734474|Secondary|Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve|Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.|Baseline through 52 weeks|Randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) who had blood samples collected for PK assessments.|||nanograms times hours per milliliter||Standard Deviation|Mean
2770425|NCT00734474|Secondary|Resource Utilization|The number of visits to the emergency room (ER) is summarized cumulatively.|Baseline through 52 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.|||events|||Number
2770426|NCT00734474|Secondary|Participant-reported Outcomes, EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable EQ-5D data. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
2770427|NCT00734474|Secondary|Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)|"The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants' quality of life. Items are scored on a 5-point numeric rating scale where 5 = always true and 1 = never true. Items are summed into 6 scales (physical function [11 items], self-esteem [7 items], sexual life [4 items], public distress [5 items], work [4 items], and total score [31 items]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale."|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable IWQoL-Lite data. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
2770428|NCT00734474|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable ECG data. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
2770429|NCT00734474|Secondary|Change From Baseline in Blood Pressure|Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable SBP and DBP data. If there were no data after the date of randomization, the endpoint was considered missing.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2770439|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||participants|||Number
2770430|NCT00734474|Secondary|Change From Baseline in Pulse Rate|Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable pulse data. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2770431|NCT00734474|Secondary|Change From Baseline in Blood Pressure at Dose Decision Point|Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting SBP and DBP data.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2770432|NCT00734474|Secondary|Change From Baseline in Pulse Rate at Dose Decision Point|Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting pulse rate data.|||beats per minute (bpm)||Standard Deviation|Mean
2770433|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Lipid Tests|The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], and triglycerides [TG]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
2770434|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
2770435|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .|Baseline through 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
2770436|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
2770437|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 104 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.|||participants|||Number
2770438|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|All randomized participants in the LY2189265 and active comparator (Sitagliptin) arms.|||participants|||Number
2770440|NCT00734474|Secondary|Beta Cell Function and Insulin Sensitivity (HOMA2)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point and who had evaluable HOMA2 data. If there were no data after the date of randomization, the endpoint was considered missing.|||HOMA2-%||Standard Error|Least Squares Mean
2770441|NCT00734474|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||episodes per participant per year||Standard Deviation|Mean
2770442|NCT00734474|Secondary|Incidence of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||participants|||Number
2770443|NCT00734474|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|The percentage of participants achieving HbA1c levels <7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2770444|NCT00734474|Secondary|Waist Circumference Change From Baseline|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable waist circumference data. If there were no data after the date of randomization, the endpoint was considered missing.|||centimeters (cm)||Standard Error|Least Squares Mean
2770445|NCT00734474|Secondary|Durability of Change From Baseline Body Weight|Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable body weight data. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
2770446|NCT00734474|Secondary|Body Weight Change From Baseline|Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable body weight data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
2770447|NCT00734474|Secondary|Change From Baseline in Body Weight at Dose Decision Point|Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable body weight data.|||kilograms (kg)||Standard Deviation|Mean
2770448|NCT00734474|Secondary|Fasting Insulin Change From Baseline|Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable fasting insulin data. If there were no data after the date of randomization, the endpoint was considered missing.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
2770449|NCT00734474|Secondary|Fasting Blood Glucose Change From Baseline|Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable fasting plasma glucose data. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2770450|NCT00734474|Secondary|Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable HbA1c data. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
2770451|NCT00734474|Secondary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
2770452|NCT00734474|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point|Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable HbA1c data.|||percentage of HbA1c||Standard Deviation|Mean
2770453|NCT00734474|Primary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
2770454|NCT00734409|Secondary|Mean Days on Mechanical Ventilation|The mean number of days that the patients were on mechanical ventilation.|ICU stay- through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||Days||Standard Deviation|Mean
2770455|NCT00734409|Secondary|Unplanned Self-device Removal Events|The number of unplanned self-device removal events that took place during the study period.|ICU stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||Event|||Number
2770456|NCT00734409|Primary|Mean Sedative Use|The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.|Intensive Care Unit (ICU) stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||ml/hour||Standard Deviation|Mean
2770457|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 11 Months|Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|11 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 9 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 9 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770458|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 10 Months|Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770483|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 12 Months|Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
2776329|NCT00697593|Primary|Biochemistry - Aspartate Transaminase (AST)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 2 participants missing values|||IU/L||Standard Deviation|Mean
2770459|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 9 Months|Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|9 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 8 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770460|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 8 Months|Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770461|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 7 Months|Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|7 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770462|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 6 Months|Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770463|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 5 Months|Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|5 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770464|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 4 Months|Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770465|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 3 Months|Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|3 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770466|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 2 Months|Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 1 subject because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
2770467|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 1 Months|Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|1 month after baseline||||cells/mm3||Full Range|Mean
2770468|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 14 Months|The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
2770469|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 12 Months|The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
2770470|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 10 Months|The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
2770471|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 8 Months|The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
2770472|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 6 Months|The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
2770583|NCT00733993|Primary|Visual Analog Scale Subjective Rating of Drug Effects|Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.|Immediately after dose||||units on a scale||Standard Error|Mean
2770844|NCT00732940|Secondary|Median Percent Change From Baseline in Compliment C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770473|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 4 Months|The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
2770474|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 2 Months|The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm|||count per microliter||Full Range|Mean
2770475|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 14 Months|Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770476|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 12 Months|Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770477|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 10 Months|Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770478|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 8 Months|Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770479|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 6 Months|Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770480|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 4 Months|Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770481|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 2 Months|Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
2770482|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 14 Months|Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
2770845|NCT00732940|Secondary|Absolute Change From Baseline in Complement C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.|||mg/L||Standard Error|Mean
2770484|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 10 Months|Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
2770485|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 8 Months|Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
2770486|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 6 Months|Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
2770487|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 4 Months|Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|4 months post baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
2770488|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 2 Months|Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|baseline to 2 months|Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy.|||white blood cells per microliter (mcL).||Full Range|Mean
2770489|NCT00734305|Secondary|To Determine the Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The AUC is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
2770490|NCT00734305|Secondary|To Determine the Pharmacokinetic and Immunogenicity Parameters of MM-121|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).~Immunogenicity data is not available."|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2770491|NCT00734305|Secondary|To Describe the Dose-limiting Toxicity of MM-121 as a Monotherapy|To establish the safety of escalating doses of MM-121 administered as a monotherapy in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 47 weeks||||participants reporting DLTs|||Number
2770492|NCT00734305|Primary|Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort from cohort 1-6. Cohort 1 began at 3.2 mg/kg IV QW and the dose escalated in separate cohorts from 6 mg/kg IV QW, 10 mg/kg IV QW, 15 mg/kg IV QW, 20 mg/kg IV QW, to the highest scheduled testing dose at 40 mg/kg one-time loading dose on cycle 1, week 1 followed by 20 mg/kg IV QW maintenance doses. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose and was used to open the expansion cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|All participants in the 6 cohorts of dose escalation|||mg/kg|||Number
2770846|NCT00732940|Secondary|Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24||Baseline, 24 weeks|LOCF|||Percentage||Standard Error|Mean
2770493|NCT00734305|Primary|Objective Response Rate and Duration|"To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response is defined as a >20% decrease in tumor burden from baseline and a Complete Response is defined as complete disappearance of tumor burden from baseline. Duration of response is defined as the length of time in weeks from observation of response until progression.~NOTE: because no patients experienced an objective response as shown below, duration of response is not presented. No duration of response could be measured."|Time from first dose to date of progression, with a median of 7.1 weeks||||participants with objective response|||Number
2770494|NCT00734214|Primary|Hyponatremia|Plasma sodium less than 135 mmol/L|during the study intervention|Intention to treat analysis|||participants|||Number
2770495|NCT00734214|Secondary|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.||During the treatment and follow-up period|||||||
2770496|NCT00734214|Primary|Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)||During the treatment and follow-up period.|||||||
2770497|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
2770498|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
2770499|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
2770500|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
2770501|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
2770502|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
2770503|NCT00734162|Secondary|Number of Participants With Changes in Drug-Resistant Mutations During the Study|The number of participants with changes in drug-resistant mutations during the study was summarized.|Baseline through Week 192|Participants with HBV DNA ≥ 400 copies/mL, with confirmed virologic breakthrough (defined as 2 consecutive increases in HBV DNA of at least 10-fold from nadir, or confirmed values ≥ 400 copies/mL after being < 400 copies/mL while on study medication), or subjects who discontinued early (after Week 24 with HBV DNA ≥ 400 copies/mL) were analyzed.|||participants|||Number
2770504|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770505|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770506|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770507|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770508|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770509|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770510|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770511|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770512|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770513|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 48|To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject's recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject's recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
2770514|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770515|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770516|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770517|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770518|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770519|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770520|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770521|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770522|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770523|NCT00734162|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2770524|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 72, 96, 144, and 192|Safety Analysis Set|||percentage of participants|||Number
2770525|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 96, 144, and 192|Safety Analysis Set|||percentage of participants|||Number
2770526|NCT00734162|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192|HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2770527|NCT00734162|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2770528|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2770529|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2770530|NCT00734162|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2770531|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2770616|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
2770532|NCT00734162|Primary|Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72|"Data were summarized by treatment and age group (grouped by baseline age for analysis).~In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192."|Baseline to Week 72|Safety Analysis Set: participants who received at least one dose of study drug.|||percentage of participants|||Number
2770533|NCT00734162|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72|"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.~In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included."|Week 72|Full Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2770534|NCT00734149|Secondary|Median Duration of Response|Duration of response is measured from date of first confirmed response until date of disease progression.|up to 4 years||||months||95% Confidence Interval|Median
2770535|NCT00734149|Secondary|Number of Patients With Any Grade or Severe Adverse Event|Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety|At any time during the study and up to 30 days after stopping the study drug||||participants|||Number
2770536|NCT00734149|Primary|Response|Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein.|6 weeks following completion of treatment||||participants|||Number
2770537|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 4 Weeks of Treatment|"Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units of scale||Standard Deviation|Mean
2770538|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 8 Weeks of Treatment|"Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
2770539|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 4 Weeks of Treatment|"Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units of scale||Standard Deviation|Mean
2770540|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 8 Weeks of Treatment|"Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
2770541|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 8 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe)."|At Baseline and 8 weeks||||Days per week with pain||Standard Deviation|Mean
2770542|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 4 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Days per week with pain||Standard Deviation|Mean
2770871|NCT00732875|Primary|Number of Subjects Experiencing Any Adverse Event||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.|||participants|||Number
2770543|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks.||||Days per week with symptoms||Standard Deviation|Mean
2770544|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks.||||Days per week with symptoms||Standard Deviation|Mean
2770545|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment|"Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units on scale||Standard Deviation|Mean
2770546|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment|"Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
2770547|NCT00734097|Secondary|Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment|Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.|At Baseline and 4 weeks||||Days per week with symptoms||Standard Deviation|Mean
2770548|NCT00734097|Primary|Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment|Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline|At Baseline and 8 weeks||||Days per week with symptoms||Standard Deviation|Mean
2770549|NCT00734071|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).|||participants|||Number
2770550|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770551|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770552|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770553|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770554|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770555|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770556|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770557|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770558|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770559|NCT00734071|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770560|NCT00734071|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2770561|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770562|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used; n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2770890|NCT00732615|Secondary|Percentage Changes From Baseline in Daily Calcium Dose at Week 24.|The analysis of this endpoint was based on investigator prescribed data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data|||percentage change from baseline||Standard Deviation|Mean
2770563|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770564|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770565|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770566|NCT00734071|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2770567|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770568|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770569|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.|||percentage of participants|||Number
2770570|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770571|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770572|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770573|NCT00734071|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2770574|NCT00734032|Secondary|Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value).|Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)|FAS Population with LOCF analysis.|||Log(millimole per milliliter per minute)||Geometric Coefficient of Variation|Geometric Mean
2770575|NCT00734032|Secondary|Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by [Baseline value]).|Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)|FAS Population with LOCF analysis.|||Percent inhibiton of Lp-PLA2 activity||Standard Deviation|Mean
2770576|NCT00734032|Primary|Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value).|Baseline (Week 0, Visit 2) and Week 4|Full Analysis Set (FAS) Population was defined as all randomized participants who received at least one dose of study medication during treatment period and who had at least one evaluable assessment of Lp-PLA2 activity after randomization. Missing values during treatment period, except for Baseline were imputed by last observed response (LOCF).|||Log(millimole per milliliter per minute)||Geometric Coefficient of Variation|Geometric Mean
2770577|NCT00733993|Secondary|Saliva Caffeine and Paraxanthine Levels|"Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.~Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls."|30 minutes prior to dose, 30/90/150 minutes post dose.|Assessment was not performed for amphetamine intervention|||ng/mL||Standard Error|Mean
2770578|NCT00733993|Secondary|Probabalistic Feedback Selection Task|Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.|75 minutes after dose||||accuracy||Standard Error|Mean
2770579|NCT00733993|Primary|Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects|Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.|Immediately after dose||||units on a scale||Standard Error|Mean
2770580|NCT00733993|Primary|Addiction Research Center Inventory Subjective Rating of Drug Effects|"Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.~Includes the following subscales:~Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and intellectual efficiacy (+4 to +9, higher scores = more energy)"|Immediately after dose||||units on a scale||Standard Error|Mean
2770581|NCT00733993|Primary|Heart Rate|Sitting heart rate|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours||||Beats per minute||Standard Error|Mean
2770582|NCT00733993|Primary|Systolic and Diastolic Blood Pressure|Sitting Blood Pressure|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours||||mmHg||Standard Error|Mean
2770584|NCT00733980|Secondary|Discontinuation-Emergent Signs and Symptoms|The discontinuation signs and symptoms scale consisted of 43 signs and symptoms, scored as 'new symptom (NS)', 'old symptom (OS) but worse', 'OS but improved' or ' symptom not present/old symptom but unchanged'. The total number of new signs and symptoms, old symptoms but worse, and old symptoms but improved was calculated for each participant. The number of participants with Discontinuation-Emergent Signs and Symptoms were reported. The visits were at Week 6 Visit, 7-D FU and 28-D FU visit.|At Week 6, 7-day (D) FU and 28-D FU|All subject population.|||Participants|||Count of Participants
2770585|NCT00733980|Secondary|Number of Participants With Hormonal Data of PCI|The number of participants with hormone values outside the CRI were reported. The hormone data was analyzed for parameters like Cortisol total, Dehydroepiandrosterone, Thyroxine, free, and thyroid stimulating hormone (TSH) .|up to Week 10|All subject population.|||Participants|||Count of Participants
2770586|NCT00733980|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range|The number of participants with clinical chemistry values outside the clinical importance range (CIR) were reported. The values for chemistry parameters outside CRI were reported for Alanine amino transferase (ALT), Aspartate amino transferase, total bilirubin, calcium, Creatine Kinase, carbon dioxide (CO^2) content/bicarbonate (BC), glucose and potassium were reported.|Upto Week 10|All subject population.|||Participants|||Count of Participants
2770587|NCT00733980|Secondary|Number of Participants With Abnormal Hematology Values of PCI-Platelet|Number of participants with abnormal Hematology values of PCI were reported. The abnormal values were reported only for platelet, diagnosed at Week 6 or Early withdrawal visit.|Upto 28-day FU|All Subject population|||Participants|||Count of Participants
2770588|NCT00733980|Secondary|Number of Participants With Abnormal Electrocardiograph (ECG) Values|The 12-lead ECG, were obtained at each time-point during the study using an ECG machine. The number of participants with ECG abnormal values were reported.|Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up|All subject population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2770589|NCT00733980|Secondary|Number of Participants With Abnormal Urinalysis Data|Urinalysis included analysis for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine Leukocyte Esterase test (LET) via dipstick analysis. The number of participants with abnormal urinalysis data were reported. In the dipstick test the levels for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine LET with results of trace, negative, positive,1+=slightly positive, 2+=positive, 3+=high positive were reported.|Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU)|All subject population.|||Participants|||Count of Participants
2770590|NCT00733980|Secondary|Number of Participants With Vital Sign of Potential Clinical Importance (PCI)|Vital sign measurements included height (screening only), systolic blood pressure(SBP) and diastolic blood pressure (DBP) and heart rate (HR). Sitting vital signs were measured at all clinic visits. Standing vital signs were measured at screening, Week 3 and at any other times as clinically indicated. Only the PCI values for SBP, DBP and HR were reported.|Up to Week 10|All subject population.|||Participants|||Count of Participants
2770591|NCT00733980|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 28-day FU (18 months)|All subject population.|||Participants|||Count of Participants
2770592|NCT00733980|Secondary|Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.|The PSS is most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in past month (how unpredictable, uncontrollable, and overloaded respondents find their lives). Individual items were rated on a scale of 0-4, where 0(never) to 4 (very often) that best describes how often they have had the feelings or thoughts described in the last month for each question. The total scores can range from 0-40, where 0 score indicated no stress and a higher score indicated more stress. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. Thus a negative change from randomization indicated improvement.|Randomization (Week 0) and Week 6.|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
2770593|NCT00733980|Secondary|Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6|The MOS-12 Sleep Scale is a 12-item questionnaire which measures specific aspects of sleep in participants that may have varying co-morbidities, as a result, is appropriate for a medically diverse participant population. It consist of following items: initiation (2 items), maintenance (2 items), respiratory problems (2 items), quantity (1 item), perceived adequacy (2 items), and somnolence (3 items). All items were given equivalent weightage from 1 to 6. Each index summarizes information across most or all sleep dimensions. The total score is transformed linearly to a common metric with a possible range of 0-100 and is averaged across items in the same scale. The higher score indicates a greater degree of the attribute implied by the scale name. Change from randomization was calculated by randomization value minus the value at Week 6. Randomization was defined as Week 0.|Randomization (Week 0) and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
2770594|NCT00733980|Secondary|Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. The CGI -responders, are defined as participants with a score of 1 (very much improved) or 2 (much improved) in the CGI-I).|Weeks 1, 2, 4, and 6.||||perecntage of participants|||Number
2770872|NCT00732758|Secondary|Collagen Type 1 Cross-linked C-telopeptide (CTx)|Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.|6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.|||ng/mL||Standard Deviation|Mean
2770595|NCT00733980|Secondary|Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. Both the CGI-I and CGI-S items are rated on a 1 to 7 point scale. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). Scores, on the CGI-S, range from 1 (normal, not ill at all) to 7 (amongst the most extremely ill). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Weeks 1, 2, 4, and 6.|ITT population|||Scores on scale||Standard Error|Least Squares Mean
2770596|NCT00733980|Secondary|Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6)|"The time to maintained antidepressant response at the end of treatment phase (week 6), as the participants with a > or = to 50 % reduction from randomization in their HAMD-17 total score, sustained until the end of the Treatment Phase [Week 6]). This OM time to maintained antidepressant response was not evaluated due to lower number of participants in the GSK561679 group as compared to placebo"|Week 6|Endpoint not evaluated.||||||
2770597|NCT00733980|Secondary|Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.|HAMD-17 Responders were defined as the participants with a > or = 50% reduction from randomization in their HAMD-17 total score at Weeks 1, 2, 4, and 6. The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranged from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicated at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity.|Weeks 1, 2, 4, and 6.|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2770598|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)|The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranges from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2, 4 and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
2770599|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.|The IDS-SR is self-report rating scale that assesses symptom severity of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), diagnostic criterion for major depressive disorder. The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. Each item has a 4-likert scale and each symptom item is given equivalent weightings and scored on 0 to 3 scale, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2,3, 4 and 6). Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2, 3,4 and Week 6|ITT population|||Scores on scale||Standard Error|Least Squares Mean
2770600|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)|HAM A, is internationally accepted and validated measurement tool for assessment of severity of anxiety symptoms. Used to assess severity of overall anxiety in participants who met criteria for anxiety of depressive disorders and to monitor outcome of treatment. Instrument does not distinguish symptoms of specific anxiety disorder or distinguish an anxiety disorder from an anxious depression. It is clinician-administered and consists of 14 individual questions, each rated on five point scale from 0 (not present) to 4 (very severe). Total HAM A range from 0 to 56 with higher scores reflecting more severe anxiety. Change from randomization was defined as post-baseline value minus value at randomization. Randomization was defined as Week 0. Provided no more than 1 response was missing for any one visit assessment for a participant, total score was calculated adjusting for missing data as follows: Total score = (14/13)* observed total score the score was rounded to nearest integer number.|Randomization (Week 0) and Week 1, 2, 4 and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
2770601|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.|The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2 and 4). Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2 and 4|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
2770617|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
2770618|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
2770873|NCT00732758|Secondary|Osteocalcin (OC)|Marker of bone formation|6 months|Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.|||ng/mL||Standard Deviation|Mean
2770602|NCT00733980|Primary|Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).|The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Week 6|Intent to Treat (ITT) population consisted of all participants who gave informed consent, were randomized, received at least one dose of double-blind medication, and had at least one post-randomization efficacy assessment available (HAM D, IDS-SR CGI, HAM A, MOS, PSS).|||Scores on scale||Standard Error|Least Squares Mean
2770603|NCT00733954|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment|Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|Safety|||Participants|||Number
2770604|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||% BSA||Standard Deviation|Mean
2770605|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||% BSA||Standard Deviation|Mean
2770606|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment|Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||% BSA||Standard Deviation|Mean
2770607|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||% BSA||Standard Deviation|Mean
2770608|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment|Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF|||% BSA||Standard Deviation|Mean
2770609|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment|Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF|||% BSA||Standard Deviation|Mean
2770610|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
2770611|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
2770612|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
2770613|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
2770614|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
2770615|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
2770619|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
2770620|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment|Baseline and Week 2||||Participants|||Number
2770621|NCT00733954|Primary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|Intent-to-treat (ITT), Last observation carried forward (LOCF)|||Participants|||Number
2770622|NCT00733824|Secondary|Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event||30 days post transplant||||participants|||Number
2770623|NCT00733824|Secondary|Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype||1 year||||mean percentage of total CD34+ cells||Standard Deviation|Mean
2770624|NCT00733824|Secondary|Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration||From baseline to Day 1||||fold change||Full Range|Median
2770625|NCT00733824|Primary|Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study|Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.|7 days from first dose of IV AMD3100||||participants|||Number
2770626|NCT00733824|Primary|Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)|"MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.~DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause."|7 days from first dose of IV AMD3100||||micrograms/kilograms|||Number
2770627|NCT00733746|Secondary|Response Rate|The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for protocol surgery were included in this endpoint.|||proportion of patients||95% Confidence Interval|Number
2770628|NCT00733746|Secondary|Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.|Up to 4 years postoperative chemotherapy treatment|All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.|||Participants|||Count of Participants
2770629|NCT00733746|Secondary|Relapse/Progression-free Survival|Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.|||months||95% Confidence Interval|Median
2770630|NCT00733746|Secondary|Resection Rate|"The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval.~Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles).~An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins)."|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for surgery were included in this endpoint.|||proportion of patients||95% Confidence Interval|Geometric Least Squares Mean
2770631|NCT00733746|Primary|Overall Survival at 2 Years|The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.|||proportion of patients||95% Confidence Interval|Number
2770632|NCT00733512|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|1 week to 10 months|contrast sensitivity data was received for only 51 of 146 patients.|||log units||Standard Deviation|Mean
2770633|NCT00733512|Primary|Visual Acuity|"Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity."|1 week to 10 months||||logMAR||Standard Deviation|Mean
2770634|NCT00733499|Secondary|Number of Participants With Tibial Radiolucency, Greater Than 2mm|Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, >2mm unstable.|3 months to 120 months|Subjects within safety population with complete, available data.|||Participants|||Count of Participants
2770635|NCT00733499|Secondary|Number of Participants With Tibial Radiolucency, 1mm-2mm|Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, >2mm unstable.|3 months to 120 months|Subjects within safety population with complete, available data.|||Participants|||Count of Participants
2770636|NCT00733499|Secondary|Number of Participants With Tibial Radiolucency, 0-1mm|Zonal Analysis of the 6 zones of the tibial component was determined from the post operative radiographs. Osteo-fixation was graded using the following system 0-1 mm radiolucencies will be classed as fixated, 1-2mm not fixated, >2mm unstable.|3 months to 120 months|Subjects within safety population with complete, available data.|||Participants|||Count of Participants
2770637|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|120 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770638|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|60 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770639|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|24 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770640|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|12 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770641|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|6 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770707|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770642|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|3 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770643|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Physical Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Preop.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The physical composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|preop|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770644|NCT00733499|Secondary|Survivorship Analysis|The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.|9.99 years|10 Year survivorship could not be calculated due to N <40 but could be calculated at 9.99 years.|||Percentage of Participants||95% Confidence Interval|Number
2770645|NCT00733499|Secondary|Survivorship Analysis|The survival of each group is assessed using Kaplan-Meier curves. Revision for any reason constitutes an event.|5 Years||||Percentage of Participants||95% Confidence Interval|Number
2770646|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|120 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770647|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|60 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770648|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|24 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770649|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|12 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770650|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|6 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770705|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|2 years|106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770651|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|3 months|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770652|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Quality of Life Assessed by SF-12 (Mental Composite) Questionnaire Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.|The SF-12 consists of 12 questions that explores issues that apply to people have many different types of treatment, and in all different states of health, from good to bad. The mental composite score ranges from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health.|pre-op|The number of participants analysed is based on the number of case report forms measuring the SF-12 that we have in our database at the preop time point. Please note-due to a discrepancy in an early version of the SF12 case report from, a complete score could not be calculated which reflected in missing counts for early visits.|||units on a scale||Standard Deviation|Mean
2770653|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 120 Months.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|120 months|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770654|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 60 Months.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|60 months|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770655|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 24 Months.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|24 months|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770656|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|12 months|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770657|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|6 months|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770658|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 3 Months.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|3 months|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770659|NCT00733499|Secondary|Comparative Evaluation of Any Variability in Functional Recovery Using the Oxford Knee Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at Pre-op.|The Oxford Knee Score questionnaire consists of 12 questions each with a choice of responses and is designed to evaluate the subjects' perception of the condition and functionality of their affected joint and the impact that it has on their normal daily activities. Overall scores range from 0 (most severe symptoms) to 48 (least symptoms) with 48 being the best outcome.|Pre-op|The number of participants analysed is based on the number of case report forms measuring the Oxford Knee Score that we have in our database at the preop time point.|||units on a scale||Standard Deviation|Mean
2770660|NCT00733499|Primary|Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 12 Months.|The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint|12 Months Post Surgery|The number of participants analysed is based on the number of case report forms measuring the VAS pain score that we have in our database at the 12 month time point.|||units on a scale||Standard Deviation|Mean
2770661|NCT00733421|Secondary|Patient Assessed Quality of Life|Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life|At 16-week post surgery follow-up||||score on a scale||Standard Deviation|Mean
2770662|NCT00733421|Secondary|Patient Assessed Overall Satisfaction With Surgery/Outcome|overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.|16 weeks||||Patients.|||Number
2770663|NCT00733421|Secondary|Satisfaction With Pain Medication|satisfied or unsatisfied with study medication, assessed by patient in questionnaire|during the first 20 days after surgery, 1st outpatient clinic visit||||patients|||Number
2770664|NCT00733421|Secondary|Wound Healing|healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad|16 week follow-up||||patients|||Number
2770665|NCT00733421|Secondary|Dizziness/Sleepiness|Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire|During the 7-day pain medication period||||patients|||Number
2770666|NCT00733421|Secondary|Gastro-intestinal Symptoms|Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire|during the 7- day pain medication period||||patients|||Number
2770667|NCT00733421|Secondary|Compliance to Base Medication|Number of patients that did not discontinue study medication before day 7|7-day study period, during study medication||||patients|||Number
2770668|NCT00733421|Secondary|Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain|VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70|The first 7 days after surgery, during study pain medication||||scores on a scale||Standard Deviation|Mean
2770669|NCT00733421|Primary|Number of Patients Requiring Rescue Medication|Number of patients requiring any further pain medication|7 day study period||||patients|||Number
2770670|NCT00733408|Secondary|Changes in Levels of Circulating Endothelial Cells|Descriptive statistics, such as mean and standard deviation, will be summarized for circulating endothelial cells at baseline and last visit.|Baseline to up to 8 years||||log10 of CEC per mL||Standard Deviation|Mean
2770671|NCT00733408|Secondary|Changes in Levels of Circulating Tumor Cells|Descriptive statistics, such as mean, standard deviation, and range, will be summarized for circulating tumor cells at baseline and last visit.|Baseline to up to 8 years||||log10 of CTC per mL||Standard Deviation|Mean
2770672|NCT00733408|Secondary|EGFR and SPARC Expression in the Primary Tumor||Up to 8 years|Data published that shows that running assay does not provide useful results||||||
2770673|NCT00733408|Secondary|Incidence of Adverse Events as Assessed by National Cancer Institute CTCAE Version 3.0|Adverse events that meet severity grade 2 or greater will be collected and reported. The number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be summarized for all patients, and stratified by center and other subgroups of interest.|Up to 30 days after treatment discontinuation|Of the 59 patients enrolled, 4 patients failed to complete a single cycle of induction and considered invaluable and therefore were removed from efficacy analysis. Safety analysis included all 59 patients.|||Participants|||Count of Participants
2770674|NCT00733408|Secondary|Percentage of Participants With Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 years||||percentage of participants||90% Confidence Interval|Number
2770675|NCT00733408|Secondary|Overall Survival|Kaplan-Meier survival curves will be used.|Time from date of registration to date of death due to any cause, assessed up to 8 years||||Months||95% Confidence Interval|Median
2770676|NCT00733408|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.|Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years||||Months||95% Confidence Interval|Median
2770677|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
2770708|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|Study terminated early due to a slow recruitment rate. 5 year data not available.||||Participants||
2770678|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770679|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)}|||Points|Participants|Standard Deviation|Mean
2770680|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770681|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770682|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770683|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770684|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
2770685|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770706|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770686|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770687|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770688|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
2770689|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770690|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770691|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770692|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
2770693|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770694|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770695|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770696|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early to slow recruitment rate. 5 Year data not available.||||Participants||
2770697|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770698|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770699|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770700|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.||||Participants||
2770701|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)}|||Points|Participants|Standard Deviation|Mean
2770702|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 year|106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770703|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770704|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.||||Participants||
2770738|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.|pre-op|There were 5 missing outcomes for this endpoint.|||Feet||Standard Deviation|Mean
2770709|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}|||Points|Participants|Standard Deviation|Mean
2770710|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }|||Points|Participants|Standard Deviation|Mean
2770711|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
2770712|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
2770713|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}|||Points|Participants|Standard Deviation|Mean
2770714|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}|||Points|Participants|Standard Deviation|Mean
2770715|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770716|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate, 5 year data not available.||||Participants||
2770717|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}|||Points|Participants|Standard Deviation|Mean
2770739|NCT00733330|Secondary|To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.|An independent radiographer will observe and record alignment|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
2770740|NCT00733330|Secondary|To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographer will observe and record alignment.|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
2770718|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}|||Points|Participants|Standard Deviation|Mean
2770719|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770720|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to a slow recruitment rate.||||Participants||
2770721|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770722|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770723|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770724|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study was terminated early due to a slow recruitment rate. 5 year data not available.||||Participants||
2770725|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770726|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770803|NCT00733278|Primary|Successful Retention of IUD||6 weeks||||participants|||Number
2770727|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770728|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study has been terminated early, therefore the 5 year data was not collected.||||Participants||
2770729|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770730|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}|||Points|Participants|Standard Deviation|Mean
2770731|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
2770732|NCT00733369|Primary|Change From Pre-op to 1 Year Range of Motion.|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)}|||Degrees|Participants|Standard Deviation|Mean
2770733|NCT00733356|Primary|Gray Oral Reading Rest, Fourth Edition (GORT-4)|"The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B.~The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study."|baseline and final day (lab school Assessments)||||units on a scale||Standard Deviation|Mean
2770734|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|6 months|There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
2770735|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|12 weeks|There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
2770736|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|8 weeks|There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
2770737|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|4 weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.|||Feet||Standard Deviation|Mean
2770804|NCT00733226|Secondary|Effect of OM-85 BV on Cytokine Levels|Cytokine levels were not measured during the trial because of unavailability of laboratory resources.|6 months|||||||
2770741|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|6 months|There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||millimeters||Standard Deviation|Mean
2770742|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|12 Weeks|There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||millimeters||Standard Deviation|Mean
2770743|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|8 Weeks|There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.|||millimeters||Standard Deviation|Mean
2770744|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|4 Weeks|There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.|||millimeters||Standard Deviation|Mean
2770745|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|pre-op|There were 3 missing outcomes for this endpoint.|||millimeters||Standard Deviation|Mean
2770746|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|5 years|The study was terminated early for business reasons therefore there are no outcomes for this endpoint.||||||
2770747|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|2 years|There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770748|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|1 year|There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770749|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|6 months|There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770750|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|12 weeks|There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770751|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|8 weeks|There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770752|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|4 Weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.|||points||Standard Deviation|Mean
2770753|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|pre-op|There were 4 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
2770754|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|The study was terminated before completion due to business purposes, therefore there are no results for this outcome.||||||
2770755|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770756|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 Year|There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
2770757|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|6 Months|There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
2770758|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|12 Weeks|There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
2770759|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
2770760|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this outcome.|||points||Standard Deviation|Mean
2770761|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|pre-op|There were 2 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
2770762|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.||||||
2770763|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.|||points||Standard Deviation|Mean
2770764|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.|||points||Standard Deviation|Mean
2770765|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|6 Months|There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
2770766|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|12 Weeks|There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
2770767|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
2770768|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this endpoint.|||points||Standard Deviation|Mean
2770769|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Pre-op|Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
2770770|NCT00733330|Secondary|To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.|4 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
2770771|NCT00733330|Secondary|To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographic observer will determine and record alignment.|operative|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
2770772|NCT00733330|Primary|To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)|6 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.||||||
2770773|NCT00733304|Secondary|Number of Participants With Lesion Types Over Period|Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.|Up to 6 months|Safety population.|||Participants|||Count of Participants
2770774|NCT00733304|Secondary|Change in Neo-vascular Size and Lesion Size Over Period|The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure.|Up to 6 weeks|PD population was planned for analysis of this outcome; however, Data was not collected for this outcome measure.||||||
2770775|NCT00733304|Secondary|Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months|The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.|From Baseline (Screening visit) and up to 5 months|Pharmacodynamic subpopulation included participants that were analyzed for PD outcome measures. Only the participants available at the time of assessment were analyzed.|||Microns||Standard Deviation|Mean
2770776|NCT00733304|Secondary|Change From Baseline (Screening Visit) in BCVA at Month 2 and 5|Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.|From Baseline (screening visit), Month 2, and Month 5|Efficacy population included all participants in safety population who have classic choroidal neovascularization present as detected by fluorescein angiography in the previous screening visit.|||Number of letters||Standard Deviation|Mean
2770777|NCT00733304|Primary|Number of Participants With Abnormal (Dilated) Fundus Examination|Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
2770778|NCT00733304|Primary|Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function|Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
2770779|NCT00733304|Primary|Number of Participants With Abnormal Tear Films of PCI|Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
2770780|NCT00733304|Primary|Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale|A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma.|Approximately up to 6 months|Safety population|||Participants|||Count of Participants
2770781|NCT00733304|Primary|Number of Participants With Abnormal Corneal Examination of PCI|A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period).|Approximately up to 6 months|Safety population|||Participants|||Count of Participants
2770782|NCT00733304|Primary|Number of Participants With Abnormal Anterior Chamber Examination of PCI|A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
2770783|NCT00733304|Primary|Number of Participants With Abnormal Conjunctival Examination of PCI|A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months).|Up to follow-up (approximately 6 months)|Safety population.|||Participants|||Count of Participants
2770784|NCT00733304|Primary|Number of Participants With Abnormal Pupil Examination of PCI|Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined.|Up to follow-up (approximately 6 months)|Safety population.|||Participants|||Count of Participants
2770785|NCT00733304|Primary|Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)|Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented.|Approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2770786|NCT00733304|Primary|Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)|Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
2770787|NCT00733304|Primary|Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis|In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive).|Approximately up to 6 months (up to follow-up)|Safety population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2770788|NCT00733304|Primary|Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2770789|NCT00733304|Primary|Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed|||Femtoliters||Standard Deviation|Mean
2770805|NCT00733226|Secondary|Duration of Hospitalization/Per Patient|Over the 12 months of the study we calculated mean duration of hospitalization/per patients.|12 months||||day/per patient||Standard Error|Mean
2770790|NCT00733304|Primary|Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period|Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2770791|NCT00733304|Primary|Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Micromoles per Liter (umol/L)||Standard Deviation|Mean
2770792|NCT00733304|Primary|Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||Percentage of cells||Standard Deviation|Mean
2770793|NCT00733304|Primary|Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||Giga per Liter (G/L)||Standard Deviation|Mean
2770794|NCT00733304|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period|ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||International units per Liter (IU/L)||Standard Deviation|Mean
2770795|NCT00733304|Primary|Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period|Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1), Month 2, 5 and approximately up to Month 6|Safety population. Only the participants available at the time of assessment were analyzed.|||Grams per liter||Standard Deviation|Mean
2770796|NCT00733304|Primary|Change From Baseline (Day 1) in Heart Rate Over Period|Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range < 50 beats per minute (bpm) or >110 bpm.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||bpm||Standard Deviation|Mean
2770797|NCT00733304|Primary|Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was <80 or >140 mm Hg and DBP was <40 or >90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour.|Baseline (Day 1) and approximately up to 6 months|Safety population included all participants who received at least one dose of the study drug. Only those participants available at the time of assessment were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2770798|NCT00733291|Primary|Total Corneal Staining Type|Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
2770799|NCT00733291|Secondary|Ocular Redness|"Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red."|After two hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
2770800|NCT00733291|Primary|Average Corneal Staining Area|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Percentage area of cornea||Standard Deviation|Mean
2770801|NCT00733291|Secondary|Ocular Comfort|"Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable."|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
2770802|NCT00733278|Secondary|Visibility Within the Vagina of IUD Strings at All Times.||At 3 days, 2 weeks and 6 weeks postpartum||||participants|||Number
2770806|NCT00733226|Secondary|Number of Hospitalizations|"During the study period of 12 months all hospitalizations for wheezing attacks were recorded.~Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.~This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial."|12 months||||hospitalization/per patient||Standard Error|Mean
2770807|NCT00733226|Secondary|Number of Wheezing Attacks That Required Systemic Steroid Therapy|"All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.~At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group."|12 months||||wheezing attacks/per patient||Standard Error|Mean
2770808|NCT00733226|Secondary|Number of Common Cold|"All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.~This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial."|12 months||||common cold/per patients||Standard Error|Mean
2770809|NCT00733226|Secondary|Mean Duration (in Day) of Wheezing Attacks Per Patient|Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.|12 months||||day/per patient||Standard Error|Mean
2770810|NCT00733226|Primary|Mean Rate of Wheezing Attacks|Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.|12 months||||wheezing attacks/per patient||Standard Error|Mean
2770811|NCT00733135|Secondary|Preservation of Run-off Distal to the Filter|Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.|at the end of the procedure|115/133 subjects had the required angiographic images to assess this outcome.|||percentage of participants|||Number
2770812|NCT00733135|Secondary|Presence of Debris in Deployed SpiderFx™ Embolic Protection Device|Presence of debris in deployed SpiderFx™ embolic protection device|at the end of the procedure||||percentage of deployed filters|Participants||Number
2770813|NCT00733135|Secondary|Residual Diameter Stenosis|This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.|at the end of the procedure|1 lesion not included because there is no angiographic core laboratory post-treatment data available|||percentage of lesions|Participants||Number
2770814|NCT00733135|Secondary|Technical Procedural Success|"Technical Procedural Success was defined as meeting all of the following requirements:~Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory~No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)~No device malfunction causing the procedure to be aborted~Successful delivery and placement of the SpiderFX™ embolic protection device"|at the end of the procedure|Total patient population minus one patient because there was no angiographic post-treatment core lab data available.|||percentage of participants|||Number
2770815|NCT00733135|Primary|Major Adverse Event Free Rate 30 Days|MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).|30 Days||||percentage of participants||95% Confidence Interval|Number
2770816|NCT00733135|Primary|Successful Revascularization|Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory|at the end of the procedure|Number of lesions assessed by the angiographic core lab|||percentage of lesions|Participants|95% Confidence Interval|Number
2770817|NCT00733096|Secondary|Medication Reduction|Number of people who reduced medications|1 month|Patients who underwent epidural steroid injections|||participants|||Number
2770818|NCT00733096|Secondary|Global Perceived Effect|Satisfaction. Number of participants with positive perceived global satisfaction.|1 month|Subjects who underwent epidural steroid injections|||participants|||Number
2770819|NCT00733096|Secondary|Oswestry Disability Score|0-100%. 0= no disability, 100% is complete disability|1 month|Patients who received epidural steroid injections|||percentage of disability out of 100%||95% Confidence Interval|Mean
2770820|NCT00733096|Primary|Numerical Rating Leg Pain Score|0-10 pain score. 0= no pain, 10= worst imaginable pain.|1 month|Patients who received epidural steroid injections|||units on a scale||95% Confidence Interval|Mean
2770821|NCT00733005|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.|15 days of treatment|Standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
2770822|NCT00733005|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|Standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
2770837|NCT00732940|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
2770838|NCT00732940|Secondary|Median Percent Change From Baseline in HDL at Week 24||Baseline, 24 week|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770823|NCT00732992|Secondary|Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants|Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.|End of study (Up to individual study discontinuation)|Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.|||Participants|||Number
2770824|NCT00732992|Secondary|Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose|Participants who provided a plasma concentration data was included in the analysis|||nanogram/mL||Standard Deviation|Mean
2770825|NCT00732992|Secondary|Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|"Terminal phase elimination half-life was calculated as natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)."|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||hours||Standard Deviation|Mean
2770826|NCT00732992|Secondary|AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||microgram*hour/mL||Standard Deviation|Mean
2770827|NCT00732992|Secondary|Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1||Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||microgram/mL||Standard Deviation|Mean
2770828|NCT00732992|Secondary|Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||hours||Full Range|Median
2770829|NCT00732992|Secondary|AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||nanogram*hour/mL||Standard Deviation|Mean
2770830|NCT00732992|Secondary|Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||nanogram/mL||Standard Deviation|Mean
2770831|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 50 mg/Day Schedule-2/1 Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 6|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."|||percent of total planned dose||Full Range|Median
2770832|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 37.5 mg/Day Continuous Daily Dosing Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 5 (end of study)|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."|||percent of total planned dose||Full Range|Median
2770833|NCT00732992|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.|End of study (up to individual discontinuation)|All subjects who received at least 1 dose of the study drug.|||Participants|||Number
2770834|NCT00732940|Secondary|Absolute Change From Baseline in Triglycerides at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
2770835|NCT00732940|Secondary|Median Percent Change From Baseline in Triglycerides at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770836|NCT00732940|Secondary|Median Percent Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770847|NCT00732940|Secondary|Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 Weeks|LOCF|||Points on a scale||Standard Error|Mean
2770848|NCT00732940|Secondary|Mean Percent Change From Baseline in PGA Score at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|LOCF|||Percentage||Standard Error|Mean
2770849|NCT00732940|Secondary|Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24|PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Last Observation Carried Forward (LOCF)|||Scores on a 3-point scale||Standard Error|Mean
2770850|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770851|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
2770852|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770853|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mL||Standard Error|Mean
2770854|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770855|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
2770856|NCT00732940|Primary|Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770857|NCT00732940|Primary|Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
2770858|NCT00732940|Secondary|Median Percent Change From Baseline in IgM at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770859|NCT00732940|Secondary|Absolute Change From Baseline in IgM at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
2770860|NCT00732940|Secondary|Median Percent Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770861|NCT00732940|Secondary|Absolute Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
2770862|NCT00732940|Secondary|Median Percent Change From Baseline in IgA at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
2770863|NCT00732940|Secondary|Absolute Change From Baseline in IgA at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
2770864|NCT00732940|Secondary|Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||µg/mL||Standard Deviation|Mean
2770865|NCT00732940|Primary|Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 24 weeks|Please see Adverse Events Section|||Percentage of participants|||Number
2770866|NCT00732901|Secondary|Cocaine Positive Urines|Number of urine drug screens positive for cocaine metabolite benzoylecgonine.|5 weeks of treatment||||Positive urine drug screens|||Number
2770867|NCT00732901|Secondary|Attentional Bias as Measured by the Cocaine Stroop Task.|Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.|5 weeks of treatment||||milliseconds||Standard Deviation|Mean
2770868|NCT00732901|Primary|Immediate Memory Task|The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.|after acute dose and after chronic administration|Numerical data values are not accessible because PI transferred institutions. See references.||||||
2770869|NCT00732875|Primary|Number of Subjects Experiencing Any Infection||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study|||participants|||Number
2770870|NCT00732875|Primary|Number of Subjects Experiencing Serious Adverse Event|Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.|throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.|||participants|||Number
2770875|NCT00732758|Primary|Serum 25-hydroxyvitamin D|Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.|6 months|Intention to treat -- participants analyzed based on the group to which they were randomized but only included in the analysis if they had follow up data at 6 months.|||ng/mL||Standard Deviation|Mean
2770876|NCT00732680|Primary|Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)|The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.|2 weeks after intervention, 2 months|No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.||||||
2770877|NCT00732654|Primary|Oral Food Challenge Threshold (OFC) Threshold|mg CM protein|Change from baseline to after therapy (up to 18 months)||||mg||Full Range|Median
2770878|NCT00732654|Primary|Change in End Point Skin Test|Allergen provoked skin test (mm)|Change from baseline to after therapy (up to 18 months)||||mm||Full Range|Median
2770879|NCT00732654|Primary|Change in CM-specific Immunoglobulin G4 (IgG4)|Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)||||kUa/L||Full Range|Median
2770880|NCT00732654|Primary|Change in CM-specific Immunogloblin E (IgE)|Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)|Data was not collected for one participant in the SLIT/OIT A group.|||kUa/L||Full Range|Median
2770881|NCT00732641|Secondary|Quality of Life|Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).|Screening and Last Observation (up to 5 years)|"Intent-to-treat population (those who received at least one dose of study drug).~The number of participants analyzed varied depending on the number of observations available for each category."|||Score on a scale||Standard Deviation|Mean
2770882|NCT00732641|Secondary|Number of Participants With Progressive Disease(PD) or Relapse From CR|"PD (for patients not in CR) required one or more of the following:~25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells;~Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas;~Development of hypercalcemia.~Relapse from CR required at least one of the following:~Reappearance of serum or urinary paraprotein;~>5% plasma cells;~Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions;~Development of hypercalcemia."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
2770883|NCT00732641|Secondary|Number of Participants With Minimal Response (MR) to Treatment|"MR was defined as:~A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks;~Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~A 25-49% reduction in the size of soft tissue plasmacytomas;~No increase in the size or number of lityc lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
2770884|NCT00732641|Secondary|Number of Participants With Partial Response (PR) to Treatment|"PR was defined as:~At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks;~Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~At least 50% reduction in the size of soft tissue plasmacytomas;~No increase in size or number of lytic bone lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
2770885|NCT00732641|Secondary|Number of Participants With Complete Response (CR) to Treatment|"CR was defined as:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks;~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed.~No increase in size or number of lytic bone lesions (development of a compression fracture did not include response);~Disappearance of soft tissue plasmocytomas."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
2770886|NCT00732641|Secondary|Number of Days of Overall Survival (OS)|"OS was calculated from the date of randomization to the date of death for any~cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)|||Days||95% Confidence Interval|Median
2770887|NCT00732641|Primary|Number of Days With Progression Free Survival (PFS)|"PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse.~PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)|||Days||95% Confidence Interval|Median
2770888|NCT00732615|Secondary|Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.|Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.|8 Weeks|Intent to Treat (ITT) population.|||percentage of participants|||Number
2770889|NCT00732615|Secondary|Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.|Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data.|||percentage of participants|||Number
2770891|NCT00732615|Primary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.|Week 24 of dosing|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2770892|NCT00732498|Secondary|Complete Response Rate|To evaluate the complete (CR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy|5 years||||Participants|||Count of Participants
2770893|NCT00732498|Secondary|Overall Response Rate|To evaluate the overall (ORR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. Descriptive and summary statistics for demographic and clinical variables obtained. The incidences of reported adverse events (AEs) tabulated. Kaplan-Meier survival analysis for PFS and OS performed on TPP. All the analyses were performed using Stata [12].|5 years||||percentage of participants|||Number
2770894|NCT00732498|Primary|Median Time to Progression|To evaluate the median TTP of patients with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.|5 years||||months||95% Confidence Interval|Median
2770895|NCT00732498|Primary|Progression-free Survival at 1 Year|To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.|1 year||||percentage of participants|||Number
2770896|NCT00732472|Secondary|Urine Half Life (t1/2) of UMEC on Day 7|Urine half life (t1/2) of UMEC on Day 7 was estimated. Urine samples were collected from 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.|||hours||Geometric Coefficient of Variation|Geometric Mean
2770897|NCT00732472|Secondary|Renal Clearance of UMEC on Day 1 and Day 7|Renal clearance was calculated as the urinary recovery of unchanged drug from time zero to time x (Ae[0-x])/area under concentration from time zero to time x (AUC[0-x]) for the longest period of time after dosing when both could be accurately determined (where x is either 8, 12, or 24). Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||Liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2770898|NCT00732472|Secondary|Fe(0-4), Fe(0-8), Fe(0-12), and Fe(0-24) of UMEC on Day 1 and Day 7|The fraction of the total dose excreted (Fe) in each interval was estimated as the urinary recovery of unchanged drug (Ae) per dose. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population: Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||Percentage of dose administered||Standard Deviation|Mean
2770899|NCT00732472|Secondary|Ae(0-4), Ae(0-8), Ae(0-12), and Ae(0-24) of UMEC on Day 1 and Day 7|Urinary recovery of unchanged drug (UMEC) within the first 8, 12, and 24 hours (Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 1 and within the first 4, 8, 12, and 24 hours (Ae[0-4], Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 7 was estimated. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||nanograms (ng)||Geometric Coefficient of Variation|Geometric Mean
2770900|NCT00732472|Secondary|Tmax and Tlastof UMEC on Day 1 and Day 7|Tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last quantifiable concentration of UMEC; both were measured on Day 1 and Day 7. Blood samples were collected pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||hours||Full Range|Median
2770901|NCT00732472|Secondary|Cmax of UMEC on Day 1 and Day 7|Cmax is defined as the maximum observed concentration of UMEC and was measured on Day 1 and Day 7. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2770920|NCT00732381|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|The standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
2770902|NCT00732472|Secondary|Mean AUC(0-2), AUC(0-8), and AUC(0-t) of UMEC on Day 1 and Day 7|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 2 hours (AUC[0-2]), from time zero to 8 hours (AUC[0-8]), from time zero to the last time of a quantifiable concentration of UMEC (AUC[0-t]) on Day 1 and Day 7 were measured. AUC is a measure of systemic exposure. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|Pharmacokinetic (PK) Population: participants (par.) in the ASP for whom a PK sample was obtained and analyzed. Different par. may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of par. summarized reflects everyone in the PK Population.|||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2770903|NCT00732472|Primary|Mean Corpuscle Volume (MCV) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCV pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||10^-15 liters (femtoliters)||Standard Deviation|Mean
2770904|NCT00732472|Primary|Mean Corpuscle Hemoglobin (MCH) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCH pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||picograms/cell (pg)||Standard Deviation|Mean
2770905|NCT00732472|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil (ANC: Absolute Neutrophil Count), Platelet, and White Blood Cell (WBC) Count Values on Day 1 and Day 7|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelets, and white blood cell (WBC) count pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2770906|NCT00732472|Primary|Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values on Day 1 and Day 7|Blood samples were collected for the measurement of calcium, glucose, potassium, sodium, and urea/BUN pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2770907|NCT00732472|Primary|Direct Bilirubin, Total Bilirubin, and Creatinine Values on Day 1 and Day 7|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2770908|NCT00732472|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Values on Day1 and Day 7|Blood samples were collected for the measurement of ALP, ALT, AST, and GGT Pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||International units per liter (IU/L)||Standard Deviation|Mean
2770909|NCT00732472|Primary|Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Concentration (MCHC) Values on Day 1 and Day 7|Blood samples were collected for the measurement of albumin, total protein, hemoglobin, and MCHC values pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Grams per liter (G/L)||Standard Deviation|Mean
2770910|NCT00732472|Primary|Total Number of Salbutamol Doses Taken Over the 7 -Day Study Period|The total number of salbutamol doses taken per day was recorded by the participants in their dairy card over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Day 1, Day 7, and Day 8. Salbutamol was given as rescue medication, defined as a quick-relief or fast-acting medication that is given in addition to the investigational drug or placebo that can alleviate symptoms due to disease or lack of efficacy of the study treatment.|Day 1 to Day 7|All Subjects Population. Only those participants who took at least one dose of salbutamol were summarized.|||salbutamol doses|||Number
2770911|NCT00732472|Primary|Mean Forced Expiratory Volume in One Second (FEV1) at Screening and on Days 1 and 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured at Screening, pre-dose, and 4 hours (hr) post-dose on Day 1 and Day 7. FEV1 tests were repeated until three technically acceptable measurements were made.|Screening, Day 1, and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Liters||Standard Deviation|Mean
2770921|NCT00732303|Secondary|Overall Survival|To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|No data was collected and analyzed for this outcome measure due to termination of the study.||||||
2770922|NCT00732303|Secondary|Assess Safety and Toxicity|- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|Most frequent toxicities reported.|||participants|||Number
2770912|NCT00732472|Primary|Maximum and Mean (0-24 Hour) Heart Rate From Holter Monitoring on Day 7|Maximum heart rate (Max HR) and mean HR from 0-24 hour Holter monitoring on treatment Day 7 were derived. The analysis was adjusted for treatment and Baseline, where Baseline is defined as the corresponding summary measure (i.e., mean heart rate [0-24 hours] or maximum heart rate [0-24 hours]) from screening records.|Day 7|All Subjects Population. The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
2770913|NCT00732472|Primary|Number of Participants With Abnormal 24-hour Holter Findings at Screening and Day 7|Twenty-four hour Holter ECG values were obtained at Screening and on Day 7. During the Screening procedure and study, standard Holter monitors were used (in order to exclude participants with underlying cardiac arrhythmogenicity). During the treatment periods, Holter monitors were only switched on immediately prior to dosing (up to 15 minutes pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. The following summary data were transcribed into the Case Report Form: Maximum and mean (0 to24 hour) heart rate; normal and aberrant beats and arrhythmias. Analysis of the Holter tapes was arranged by GlaxoSmithKline.The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at Screening and Day 7, are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Screening and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Participants|||Number
2770914|NCT00732472|Primary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Values on Days 1 and 7|The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose on Day 7 are reported. The following are of potential clinical importance: absolute QTc interval >450 milliseconds (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Day 1 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr)|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Participants|||Number
2770915|NCT00732472|Primary|Maximum and Weighted Mean (0-4 Hour) Heart Rate at Days 1 and 7|Maximum heart rate (Max HR) and weighted mean (WM) from 0-4 hour on Days 1 and 7 were derived. Max HR (0-4 h) is defined as the maximum heart rate attained within 0-4 h. The weighted mean HR (0-4 h) was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Each of the maximum and weighted mean (0-4h) endpoints for heart rate, was statistically analyzed using a mixed effects model. The terms treatment, baseline, day and any relevant interactions were considered in the model. Least squares means are adjusted for treatment, Baseline, day, treatment by Baseline and Baseline by day interaction, where Baseline is defined as the mean of the three pre-dose assessments.|Day 1 and Day 7|All Subjects Population (ASP). The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
2770916|NCT00732472|Primary|Mean Heart Rate (HR) on Days 1 and 7|HR was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. HR was obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Beats per minute||Standard Deviation|Mean
2770917|NCT00732472|Primary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) on Days 1 and 7|Blood pressure was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. SBP and DBP were obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population (ASP). Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2770918|NCT00732472|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any On-treatment Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An on-treatment adverse event is defined as an event that occurred between the start of investigational product and follow-up contact. Refer to the general SAE/non-serious AE module for a complete list of AEs reported in the study. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From start of treatment to study day 12|All Subjects Population: all participants who received at least one dose of study medication|||participants|||Number
2770919|NCT00732381|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment||||Units on a scale||Standard Deviation|Least Squares Mean
2770923|NCT00732303|Primary|Progression Free Survival|To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation|24 months|No data was collected and analyzed for this outcome measure due to termination of the study||||||
2770924|NCT00732251|Secondary|Number of Psychiatric Hospitalizations|The number of psychiatric hospitalizations that occur during the study will be compared to the number of hospitalizations that occurred prior to the study.|2 years|Data on the number of hospitalizations was not collected before or during the study||||hospitilizations||
2770925|NCT00732251|Secondary|Number of Depressive Episodes Per Patient Visit According to the Hamilton Depression Scale|The Hamilton Depression Rating Scale is a tool used to determine a patient's level of depression before, during, and after treatment. The Hamilton Depression Scale form lists 21 items, but the scoring is based on the first 17 questions. Eight items are scored on a 5-point scale, ranging from 0 (min) = not present to 4 (max) = severe. Nine are scored from 0 (min) to 2 (max). The sum of the scores from the first 17 questions is: 0 (min) to 7 (max) = normal, 8 (min) to 13 (max) = mild depression, 14 (min) to 18 (max) = moderate depression, 19 (min) to 22 (max) = severe depression and ≥ 23=very severe depression. A score of 11 or more indicates a depressive episode in terms of this outcome measure.|2 years|Total number of patient visits at which the Hamilton Depression Scale was administered per the number of patient visits at which a depressive episode (according to the Hamilton Depression Scale) was recorded. The number of depressive episodes prior to the study were not collected.|||patient visits|patient visits||Count of Units
2770926|NCT00732251|Primary|Number of Manic Episodes According to the Young Mania Rating Scale|"Young Mania Rating Scale is an 11-item, clinician-administered scale to assess severity of manic symptoms before, during and after treatment. Four items are graded on a min. 0 to max. 8 scale (irritability, speech, thought content and disruptive/aggressive behavior) while the remaining 7 items are graded on a min. 0 to max. 4 scale. A score of 0 indicates behavior is absent and score of 4 or 8 indicates the behavior is present and severe.~The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but if a subject terminates early, the last Young Mania Rating Scale score will be used. The scores from each question are added for a total score ranging from min. 0 to max 60; higher scores indicate greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild manic episode, and over 20 indicates a manic state."|2 Years|The outcome measure will be the total number of patient visits at which the Young Mania Rating Scale was administered per the number of patient visits at which a manic episode (according to the Young Mania Rating Scale) was recorded. The number of manic episodes prior to study start were not collected.|||patient visits|patient visits||Count of Units
2770927|NCT00732238|Secondary|The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy|Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)|Up to 180 days of end of therapy||||participants|||Number
2770928|NCT00732238|Primary|The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect||Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)||||participants|||Number
2770929|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes.|||Percentage of Eyes|||Number
2770930|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes.|||Percentage of Eyes|||Number
2770931|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes|||Percentage of Eyes|||Number
2770932|NCT00732225|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients.|||mmHg||Standard Deviation|Mean
2770933|NCT00732225|Secondary|Aqueous Signs - Aqueous Cells|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:~0 - None~- 1 to 5 cells~- 6 to 15 cells~- 16 to 30 cells~- >30 cells"|1 day following surgery|This data was collected on all eyes of patients attending the 1 day post-operative visit.|||Percentage of Eyes|||Number
2770934|NCT00732225|Secondary|Aqueous Signs - Aqueous Flare|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:~0-None: No visible flare when compared with the normal eye.~Mild: Flare visible against dark papillary background but not visible against iris background.~Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit.|||Percentage of Eyes|||Number
2770935|NCT00732225|Secondary|Aqueous Signs - Corneal Edema|"Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:~0 - None~- Mild, slight localized or generalized edema~- Moderate, significant localized or generalized edema~- Severe, advanced localized or generalized edema"|1 day after surgery|This data was collected on all eyes of patients attending the 1-day visit.|||Percentage of Eyes|||Number
2770936|NCT00732225|Primary|Percent Loss of Endothelial Cells|Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.|2 months following surgery|This data was collected on the eyes of patients attending the visit 2 months after surgery.|||Percent Loss||Standard Deviation|Mean
2770937|NCT00732212|Other Pre-specified|Hospital Days After Randomization|Comparisons of days spent in the ICU and hospital will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Days||Standard Deviation|Mean
2770938|NCT00732212|Secondary|Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization|RBC units of transfusion post-randomization will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Units of RBC||Standard Deviation|Mean
2770939|NCT00732212|Secondary|Death|Death up to 30 days from a co-morbid condition, bleeding, or another cause in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
2770940|NCT00732212|Secondary|Rate of Complications|Rates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, myocardial infarction, stroke) & GI procedure related (perforation, aspiration) up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
2770941|NCT00732212|Secondary|Rates of Surgery up to 30 Days After Randomization|GI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
2770942|NCT00732212|Primary|30 Day Rebleeding Rate|The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
2770943|NCT00732199|Secondary|Brief Hyperoxia Response|Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.|4-6 wks for each participant|young adults: 3 women/6 men; older adults: 6 women/4 men; participants with data available were included in the analysis|||percentage of eupneic minute ventilaion||Standard Error|Mean
2770944|NCT00732199|Secondary|Hypoxic Ventilatory Response|Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.|4-6 wks for each participant|older adults: 7 women/6 men; young adults: 6 women/4 men;participants with data available were included in the analysis|||Liter/minute/%saturation||Standard Error|Mean
2770945|NCT00732199|Primary|Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only|Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.|4-6 wks for each participant|Older adults 8 women/6 men;participants with data available were included in the analysis|||percentage of control minute ventilation||Standard Error|Mean
2770946|NCT00732199|Primary|Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve|The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.|4-6 wks for each participant|Older adults : n=10, 6 females/4 males Young n=15, 8 females/ 7 males; participants with data available were included in the analysis|||mm Hg||Standard Error|Mean
2770947|NCT00732160|Secondary|Insulin Sensitivity|Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.|||mg/kg/min per uU/mL*100||Standard Deviation|Mean
2770948|NCT00732160|Primary|Insulin Secretion|Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.|||uU/mL||Standard Deviation|Mean
2770949|NCT00732069|Secondary|F2-Isoprostanes|Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo|During dialysis after one week of study drug||||pg/mL||Standard Error|Mean
2770950|NCT00732069|Primary|Interleukin 1 Beta|Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo|During dialysis after one week of study drug|All participants who completed the three arm treatment.|||pg/mL||Standard Error|Mean
2770951|NCT00732030|Secondary|Patient Satisfaction Survey|Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.|6 months||||Units on a Scale||Standard Deviation|Mean
2770952|NCT00732030|Primary|Residual Refractive Cylinder|Residual Refractive Cylinder at month 6 measured in diopters (D).|6 Month||||Diopters||Standard Deviation|Mean
2770953|NCT00732030|Primary|Best Corrected Distance Visual Acuity|"Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA)."|6 Months|Data was collected for 29 eyes in 24 patients.|||logMAR||Standard Deviation|Mean
2770954|NCT00732030|Primary|Uncorrected Distance Visual Acuity|"Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA)."|6 months|Data was collected for 29 eyes in 24 patients.|||logMAR||Standard Deviation|Mean
2770955|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|6 months||||units on a scale||Standard Deviation|Mean
2770956|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2770957|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 9|How likely the subject will need continued training or retraining?|6 weeks||||percentage of participants|||Number
2770958|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 8|How easy was it for the subject to learn?|6 weeks||||percentage of participants|||Number
2770959|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 7|The subject likes the OTR pump?|6 weeks||||percentage of participants|||Number
2770960|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 6|The OTR pump was easy to use at 1st cycling?|6 weeks||||percentage of participants|||Number
2770961|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 5|Subject training with OTR pump was easier than with previous pump?|6 weeks||||percentage of participants|||Number
2770962|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 4|It was easy for the subject to compress the deflation touch pads?|6 weeks||||percentage of participants|||Number
2770963|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 3|It was easy for the subject to inflate the device?|6 weeks||||percentage of participants|||Number
2770964|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 2|It was easy for the subject to find the deflation touch pads?|6 weeks||||percentage of participants|||Number
2770965|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 1|It was easy for the subject to find the inflation bulb?|6 weeks||||percentage of participants|||Number
2770966|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 3|The subject was easily able to accommodate the OTR pump?|At implant||||percentage of responses|||Number
2770967|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 2|Titan OTR pre-implant product preparation was easier than your usual pump of choice?|At implant||||percentage of responses|||Number
2770968|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR Question 1|Titan OTR pre-implant product preparation was straightforward/simple?|At implant||||percentage of responses|||Number
2770969|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|12 months post-surgery||||"% responding yes and probably"|||Number
2770970|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|6 months post-surgery||||"% responding yes and probably"|||Number
2770971|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|3 months post-surgery||||"% responding yes and probably"|||Number
2770972|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|12 months post-surgery||||"% responding yes and probably"|||Number
2770973|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|6 months post-surgery||||"% responding yes and probably"|||Number
2770974|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|3 months post-surgery||||"% responding yes and probably"|||Number
2770975|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770976|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770977|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770978|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770979|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770980|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770981|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770982|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
2770999|NCT00731939|Primary|Assess the Ease of Deflation of the Titan® OTR Pump|"The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of satisfactory or somewhat satisfactory. Other possible responses were neither satisfactory nor unsatisfactory, somewhat unsatisfactory, and very unsatisfactory."|6 months||||% of participants meeting success criter|||Number
2771000|NCT00731874|Secondary|Development of New Onset Diabetes Mellitus||36 months post-transplant|Only subjects who did not have a diagnosis of diabetes mellitus at transplant are included, per protocol.|||Participants|||Count of Participants
2771001|NCT00731874|Secondary|Incidence of Opportunistic Infection||36 months post-transplant||||Participants|||Count of Participants
2771002|NCT00731874|Secondary|Severity of Acute Rejection (by Banff Criteria and Need for Anti-lymphocyte Agents to Treat Acute Rejection)|The severity of acute rejection may be assessed by the Banff criteria. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of renal allograft biopsies, and provides critical information enabling the diagnosis and grading of pathologic changes, can help to predict response to treatment, and can help to determine the long-term prognosis of the organ. Anti-lymphocyte agents (specifically rabbit anti-thymocyte globulin) are used to treat more severe cases of acute rejection, and thus may serve as a surrogate marker of severity.|36 months post-transplant|Data reported only for those subjects who developed acute rejection during the study, per protocol. Three of the 5 subjects in Arm 2 with rejection were treated with rabbit anti-thymocyte globulin.|||Participants|||Count of Participants
2771003|NCT00731874|Secondary|Incidence of Acute Rejection|Incidence of biopsy-proven acute rejection|36 months post-transplant||||Participants|||Count of Participants
2771004|NCT00731874|Secondary|Development of Donor Specific Antibody (DSA)|Percent of subjects who developed new donor specific antibody (mean fluorescence intensity > 3,000) after enrollment, within 36 months of transplant|36 months post-transplant||||Participants|||Count of Participants
2771005|NCT00731874|Secondary|Renal Function (Estimated Glomerular Filtration Rate)||36 months post-transplant|Data are not included for one subject because one subject was lost to follow-up.|||Participants|||Count of Participants
2771006|NCT00731874|Secondary|Change in Incidence and Severity of Interstitial Fibrosis/Tubular Atrophy (IF/TA) From the Baseline 3-month Biopsy to the 36-month Biopsy|Compared to the baseline biopsy performed at the time of study entry at 3 months, was there new development (incidence) or progression (severity) of interstitial fibrosis/tubular atrophy (formerly called chronic allograft nephropathy) in the biopsy performed at 36 months.|36 months post-transplant||||Participants|||Count of Participants
2771007|NCT00731874|Secondary|Graft Survival||36 months post-transplant|Data are not included for one subject because one subject was lost to follow-up.|||Participants|||Count of Participants
2771008|NCT00731874|Secondary|Patient Survival||36 months post-transplant||||Participants|||Count of Participants
2771009|NCT00731874|Primary|Number of Participants With Biopsy-confirmed Acute Rejection and/or Progression of Histologically Proven Chronic Allograft Nephropathy at 15 Months After Transplantation.||15 months post-transplant||||participants|||Number
2771010|NCT00731822|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline (pre-dose on Day 1); Day 1 and Day 28|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2771011|NCT00731822|Secondary|Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline; Day 2, Day 15, and Day 29|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2771012|NCT00731822|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study|Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.|From Baseline (Day 1) until Follow-up (up to Study Day 37)|ITT Population|||participants|||Number
2771013|NCT00731822|Primary|Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period|Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.|Baseline to Day 28|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. The number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT Population without missing covariate information and with >=1 post-BL measurement are included in the analysis.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2771014|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|12 month after enrollment|Modified intention to treat analysis|||Participants|||Number
2771015|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|6 month after enrollment|Modified intention to treat analysis|||Participants|||Number
2771016|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|3 month after enrollment|Modified intention to treat analysis|||Participants|||Number
2771017|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|1 month after enrollment|Modified intention to treat analysis|||Participants|||Number
2771018|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|12 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
2771019|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|6 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
2771020|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|3 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
2771021|NCT00731783|Primary|Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|1 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
2771022|NCT00731770|Secondary|Daytime Somnolence||1 year|Th PI has left the Institution and no outcome data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.||||||
2771023|NCT00731770|Primary|The Aim of This Study is to Determine the Effect of Fluticasone/Salmeterol on Sleep Quality in Patients With COPD and to Compare Efficacy of Advair 250 Compared to Placebo on Sleep.||1 year|Th PI has left the Institution and no outcome data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.||||||
2771024|NCT00731731|Secondary|Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)|"The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing."|Up to 5 years||||participants evaluable for toxicity|||Number
2771025|NCT00731731|Secondary|Time to Tumor Progression (Phase II)|Progression free survival time will be defined from date of registration to date of progression or death.|Up to 5 years||||months||95% Confidence Interval|Median
2771026|NCT00731731|Secondary|Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade|Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.|Up to 5 years||||participants evaluable for toxicity|||Number
2771027|NCT00731731|Primary|Overall Survival at 15 Months (Phase II)|The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.|Time from study registration to the date of death from any cause, assessed up to 5 years||||percentage of phase II patients||95% Confidence Interval|Number
2771028|NCT00731731|Primary|Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)|"The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.~>~>~DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:~Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days~Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism~Grade 4 radiation-induced skin changes~Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs"|10 weeks||||number of patients with DLT|||Number
2771029|NCT00731692|Secondary|Change in MSFC Z-score and Subscale Scores From Baseline to Month 36|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline to Month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS|||Z-scores||Standard Deviation|Mean
2771030|NCT00731692|Secondary|Blood Concentrations of Fingolimod and Fingolimod-phosphate|"Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.~Venous blood samples were collected for the analysis."|Month 3 up to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. (N). Only participants (n) who provided one or more evaluable blood concentration were included in the pharmacokinetic analysis population. Analysis include 147 patients (cohort 1)|||ng/ml||Standard Deviation|Mean
2771031|NCT00731692|Secondary|Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)|The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
2771032|NCT00731692|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
2771033|NCT00731692|Secondary|Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score|Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
2771034|NCT00731692|Secondary|Change From Baseline in PRIMUS-Activities|The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
2771035|NCT00731692|Secondary|Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)|The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
2771036|NCT00731692|Secondary|Percent Change in Total T2 Lesion Volume From Baseline to Month 36|Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percent Change||Standard Deviation|Mean
2771037|NCT00731692|Secondary|Number of Gd-enhancing Lesions at Month 36|Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Gd-enhanced lesions per patient per scan||95% Confidence Interval|Least Squares Mean
2771074|NCT00731211|Primary|Overall Response Rate|Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.|18 months||||percentage of patients||95% Confidence Interval|Number
2771038|NCT00731692|Secondary|Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36|Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||T2 Lesions per year||95% Confidence Interval|Least Squares Mean
2771039|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.|The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants|||Number
2771040|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentge of Participants|||Number
2771041|NCT00731692|Secondary|Percent Change From Baseline in Brain Volume at Month 36|The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. N= Total number of patients included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2771042|NCT00731692|Secondary|Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)|The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants||95% Confidence Interval|Number
2771043|NCT00731692|Primary|Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint|3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants||95% Confidence Interval|Number
2771044|NCT00731679|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.|||percentage of responders|||Number
2771045|NCT00731679|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.|||percentage of responders|||Number
2771046|NCT00731666|Secondary|The Rate of Change in Male Stress Urinary Incontinence(SUI).|"Subject responses to 3 questions were evaluated:~On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?~Overall, how often have you needed to change your daily activities because of urinary incontinence?~Overall, how big of a social problem has urinary incontinence been for you during the past month?"|12 months||||percentage of participants|||Number
2771047|NCT00731666|Secondary|Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.||12 and 24 months|Subjects implanted with Titan IPP|||percentage of participants|||Number
2771048|NCT00731666|Primary|The Study's Primary Objective Will Assess the Change in Penile Length.||12 months||||cm||Standard Deviation|Mean
2771075|NCT00731198|Secondary|Side Effects||Intra-procedure and 24 hours after ERCP|||||||
2771076|NCT00731198|Secondary|Frequency of Post-ERCP Complications||48 hours after ERCP|||||||
2771049|NCT00731653|Primary|The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.||Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)|All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.|||participants|||Number
2771050|NCT00731640|Secondary|Spectacle Independence|The percentage of patients reporting spectacle independence (no longer needing to wear glasses).|6 Months||||Percentage of Participants|||Number
2771051|NCT00731640|Secondary|Patient Satisfaction|Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).|6 Months Postoperative||||Units on a Scale||Standard Deviation|Mean
2771052|NCT00731640|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 Months||||Log Units||Standard Deviation|Mean
2771053|NCT00731640|Primary|Visual Acuity|"Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|6 months||||LogMar||Standard Deviation|Mean
2771054|NCT00731614|Secondary|Short Form-12 (SF-12)|the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health.|Baseline, end of treatment (8 weeks after baseline)|While a total of 49 participants completed the trial, missing data reduced the number in each condition for some analyses.|||score on a scale||Standard Deviation|Mean
2771055|NCT00731614|Primary|Phantom Limb Pain Questionnaire|The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)|Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.|Data analyzed for participants with complete data for all assessments using repeated measure ANOVA.|||units on a scale||Standard Error|Mean
2771056|NCT00731549|Secondary|Percentage of Participants Who Discontinued Due to All Causes.|Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included.|||Percentage of participants|||Number
2771057|NCT00731549|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) Score.|To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 2, 4, 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
2771058|NCT00731549|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.|PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
2771059|NCT00731549|Secondary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.|"To assess CGI-S, the rater or physician will answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
2771060|NCT00731549|Secondary|Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
2771073|NCT00731211|Secondary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months||||months||95% Confidence Interval|Median
2771061|NCT00731549|Secondary|Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.|Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse.|||Percentage of participants|||Number
2771062|NCT00731549|Secondary|Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.|"Stable was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here."|Baseline to Week 28|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.|||Percentage of participants|||Number
2771063|NCT00731549|Secondary|Percentage of Participants Achieving Remission.|Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.|Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
2771064|NCT00731549|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|"Impending relapse criteria was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage."|Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
2771065|NCT00731549|Primary|Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).|"Stable was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here."|Baseline to Week 52/Last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.|||Percentage of participants|||Number
2771066|NCT00731484|Primary|Tear Osmolarity in Human Measured by TearLab System|Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.|Single visit, at time of tear osmolarity testing.|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens Syndrome|||mOsms/L||Full Range|Mean
2771067|NCT00731341|Secondary|Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure|Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).|Post procedure||||Score from 1 to 5||Full Range|Mean
2771068|NCT00731341|Secondary|Evaluation of Length of an Average Cryoablation Procedure|Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids|Post procedure||||Minutes||Full Range|Mean
2771069|NCT00731341|Secondary|Number of Participants Discharged on Day of Cryoablation Procedure.|Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.|Post procedure||||Participants|||Number
2771070|NCT00731341|Secondary|Time (in Days) to Return to Normal Activity|The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.|4 weeks post procedure||||Days||Full Range|Mean
2771071|NCT00731341|Secondary|Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient|Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient|Prior to hospital discharge (less than 24 hours post-procedure)||||Units on a scale from 1 to 10||Full Range|Mean
2771079|NCT00731198|Primary|The Grades of the Number of Duodenal Contractions|a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.|Intra-procedure||||scores on a scale||Standard Deviation|Mean
2771080|NCT00731133|Secondary|Proportion of Amphetamine-positive Urine Samples|the proportion of urine samples positive for amphetamine. Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|thrice weekly for 6 weeks|Only data from participants who received more than one dose of disulfiram were analyzed. Of the 15 participants who entered the study, one participant received only one dose so data from 14 participants were analyzed.|||proportion of urines positive for amphet||Standard Deviation|Least Squares Mean
2771081|NCT00731133|Primary|Side Effects Checklist|It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much). Total scores range from 0 (minimum) to 100 (maximum). Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|Weekly for six weeks|Those who received more than one dose of disulfiram and/or completed more than one set of assessments during the protocol. Of the 15 participants who entered the study, one participant only attended clinic one day and so data were analyzed for 14 participants.|||units on a scale||Standard Deviation|Least Squares Mean
2771082|NCT00731120|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
2771083|NCT00731120|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Full analysis set with a Baseline SF-36 measurement; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2771084|NCT00731120|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2771085|NCT00731120|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
2771086|NCT00731120|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771087|NCT00731120|Secondary|Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771088|NCT00731120|Secondary|Percentage of Participants in HAM-A Remission at Week 8|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
2771089|NCT00731120|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
2771090|NCT00731120|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771091|NCT00731120|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
2771092|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 12|Month 12||||meters||Standard Deviation|Mean
2771093|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 6|Month 6||||meters||Standard Deviation|Mean
2771094|NCT00731094|Secondary|Physical Function: 6-Minute Walking Distance (6MWD)|Physical Function: 6MWD in meters measured at Month 0|Month 0||||meters||Standard Deviation|Mean
2771095|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 12||||scores on a scale||Standard Deviation|Mean
2771096|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 6||||scores on a scale||Standard Deviation|Mean
2771097|NCT00731094|Secondary|HRQL: SF-36 Mental Component Summary Measure (MSC)|HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 0||||scores on a scale||Standard Deviation|Mean
2771098|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 12||||scores on a scale||Standard Deviation|Mean
2771127|NCT00730964|Secondary|The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.|The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.|Within 24 hours post contrast administration||||Serious adverse events|||Number
2771099|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 6||||scores on a scale||Standard Deviation|Mean
2771100|NCT00731094|Secondary|Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)|HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 0||||scores on a scale||Standard Deviation|Mean
2771101|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
2771102|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
2771103|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
2771104|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
2771105|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
2771106|NCT00731094|Secondary|High-density Lipoprotein (HDL) Cholesterol|HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
2771107|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
2771108|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
2771109|NCT00731094|Secondary|Low-density Lipoprotein (LDL) Cholesterol|LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
2771110|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 12|Month 12||||mmHg||Standard Deviation|Mean
2771111|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 6|Month 6||||mmHg||Standard Deviation|Mean
2771112|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 0|Month 0||||mmHg||Standard Deviation|Mean
2771113|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 12|Month 12||||mmHg||Standard Deviation|Mean
2771114|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 6|Month 6||||mmHg||Standard Deviation|Mean
2771115|NCT00731094|Secondary|Systolic Blood Pressure (BP)|Systolic BP in millimeters of mercury (mmHg) measured at Month 0|Month 0||||mmHg||Standard Deviation|Mean
2771116|NCT00731094|Secondary|Weight|Weight in kilograms measured at Month 12|Month 12||||kg||Standard Deviation|Mean
2771117|NCT00731094|Secondary|Weight|Weight in kilograms at measured at Month 6|Month 6||||kg||Standard Deviation|Mean
2771118|NCT00731094|Secondary|Weight|Weight in kilograms (kg) measured at Month 0|Month 0||||kg||Standard Deviation|Mean
2771119|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12|Month 12||||participants|||Number
2771120|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6|Month 6||||participants|||Number
2771121|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0|Month 0||||participants|||Number
2771122|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire|Month 12||||participants|||Number
2771123|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire|Month 6||||participants|||Number
2771124|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire|Month 0||||participants|||Number
2771125|NCT00731055|Primary|Cigarette Choice|Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.|During each of the four weekly 6-hour experimental sessions||||number of cigarette choices (0-9)||Standard Deviation|Mean
2771126|NCT00731042|Primary|Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days|Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).|Baseline and 14 days|Analysis was done per protocol|||units on a scale||Standard Deviation|Mean
2771128|NCT00730964|Primary|The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.|A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.|Within 24 hours post contrast administration||||Serious Adverse Reactions|||Number
2771129|NCT00730925|Secondary|Summary of Pre-dose Concentrations of Afatnib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)|Day 15, 29 and 57|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2771130|NCT00730925|Secondary|Progression Free Survival (PFS) Time|PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Weeks||95% Confidence Interval|Median
2771131|NCT00730925|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
2771132|NCT00730925|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
2771133|NCT00730912|Primary|Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.|||ng•hr/mL||Standard Deviation|Mean
2771134|NCT00730912|Primary|Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.|||ng/mL||Standard Deviation|Mean
2771135|NCT00730886|Secondary|Health Care Costs||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771136|NCT00730886|Secondary|Medical Outcomes Study 36-Item Short Form Survey||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771137|NCT00730886|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771138|NCT00730886|Secondary|Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771139|NCT00730886|Secondary|C-Section Rate||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771140|NCT00730886|Secondary|Time to Conception||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771141|NCT00730886|Secondary|Miscarriage Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771142|NCT00730886|Secondary|Term Delivery Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771143|NCT00730886|Secondary|Pregnancy Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771144|NCT00730886|Primary|Live Birth Rate||Between the 3 and 9-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
2771145|NCT00730847|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (from Day 0 up to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.|||Participants|||Count of Participants
2771146|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.|||Participants|||Count of Participants
2771147|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.|During the 7-day follow-up period (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.|||Participants|||Count of Participants
2771148|NCT00730847|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.|||Participants|||Count of Participants
2771149|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771150|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771151|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771152|NCT00730756|Secondary|Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)|The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771153|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771154|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771349|NCT00729690|Secondary|Active Knee Flexion|The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2|PostOp day 2|All completed patients used.|||Degrees||Standard Deviation|Mean
2771155|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771156|NCT00730756|Secondary|Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)|The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
2771157|NCT00730756|Primary|Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)|The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.|Baseline through Week 4 (28 days)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication|||points on a scale||Standard Error|Least Squares Mean
2771158|NCT00730730|Secondary|Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.|"Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.~An ABI ≥ 0.90 is considered normal."|From baseline up to 30-days|Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb|||limbs|Participants||Number
2771159|NCT00730730|Secondary|Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.|"Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-~Category 0: Asymptomatic, no hemodynamically significant occlusive disease;~Category 1: Mild claudication;~Category 2: Moderate claudication;~Category 3: Severe claudication;~Category 4: Ischemic rest pain;~Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;~Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable"|From baseline up to 30-days|Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs|||limbs|Participants||Number
2771160|NCT00730730|Secondary|Number of Participants With Acute Success|angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)|from after stent placement to prior to hospital discharge (up to 3 days)|Intent to Treat population(ITT); missing angiographic data for one patient|||participants|||Number
2771161|NCT00730730|Primary|The Number of Participants With Major Adverse Events (MAE)|Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry|30 days|Intent-to-treat population (ITT)|||participants|||Number
2771162|NCT00730691|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
2771163|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 4 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771164|NCT00730691|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771165|NCT00730691|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2771166|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771167|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2771168|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771169|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771170|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771171|NCT00730691|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2771181|NCT00730639|Secondary|Median Time of Maximum Serum Concentration (Tmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||hours (h)||Full Range|Median
2771388|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)||12 weeks|ITT; LOCF|||percentage of superficial cells||Standard Deviation|Mean
2771172|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2771173|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; Last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2771174|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2771175|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2771176|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2771177|NCT00730691|Primary|Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
2771178|NCT00730639|Secondary|Mean Effective Half-life (T-HALFeff)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of T-HALFeff was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||hours (h)||Standard Deviation|Mean
2771179|NCT00730639|Secondary|Geometric Mean Total Body Clearance of Drug From Serum (CLT)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2771180|NCT00730639|Secondary|Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms*hours per milliliter (μg*h/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||micrograms*hours per milliliter (μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2771389|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)||12 weeks|ITT; LOCF|||percentage of parabasal cells||Standard Deviation|Mean
2776330|NCT00697593|Primary|Biochemistry - Total Bilirubin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||μmol/L||Standard Deviation|Mean
2771182|NCT00730639|Primary|Number of Participants With Abnormal Hematology Laboratory Values|Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.|||participants|||Number
2771183|NCT00730639|Secondary|Geometric Mean Maximum Serum Concentration (Cmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2771184|NCT00730639|Secondary|Duration of Tumor Response|Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed.|||months||Full Range|Median
2771185|NCT00730639|Secondary|Objective Response Rate|Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (PR). CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed.|||percentage of participants||95% Confidence Interval|Number
2771186|NCT00730639|Secondary|Immunogenicity Assessment|Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed.|||participants|||Number
2771187|NCT00730639|Primary|Number of Participants With Abnormal Serum Chemistry Laboratory Values|Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.|||participants|||Number
2771188|NCT00730639|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
2771189|NCT00730483|Secondary|Symptomatic Response by Assessing Symptom Severity in Patients|"Symptomatic response not assessed due to premature termination of study.~Scoring system for assessing symptom severity in patients with neuroendocrine/carcinoid syndrome was as follows:~- No symptoms - Patient completely asymptomatic~- Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly~- Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly~- Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities~- Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization"|Duration of study participation, average of 12 months|||||||
2771190|NCT00730483|Secondary|Biochemical Response - Time to Progression|Biochemical response not assessed due to premature termination of study.|Time to progression, 12 months|||||||
2771191|NCT00730483|Secondary|Survival|Survival outcomes not assessed due to premature termination of study.|overall survival|||||||
2776331|NCT00697593|Primary|Biochemistry - Creatinine|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||μmol/L||Standard Deviation|Mean
2771192|NCT00730483|Secondary|Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria|"Study was terminated and full outcome not assessed. The results below are based on 13 patients at 1 month post DEB-TACE, 10 patients at 6 months, and 6 patients at 12 months.~RECIST:~Complete Response (CR): Disappearance of all targeted lesions Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): At least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Cases that are not applicable for PD or PR.~EASL:~CR: Absence of any enhancement in target lesion PR: Greater than 50% decrease from baseline enhancement in target lesion PD: Greater than 25% increase in target lesion SD: All other cases"|12 months|13 patients were analyzed for 1 month post-treatment; 10 patients for 6 months post-treatment; and 6 patients at the 12 month post-treatment time point.|||Participants|||Count of Participants
2771193|NCT00730483|Primary|Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE|Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.|1 month after initial DEB-TACE treatment||||number of adverse events|||Number
2771194|NCT00730405|Secondary|The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52|A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator's assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
2771195|NCT00730405|Secondary|Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52|Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.|Baseline (Week 0/Day 1 or before) and up to Week 52|ITT analysis set. All participants were available at the time of assessment.|||Millimeters||Standard Deviation|Mean
2771196|NCT00730405|Secondary|The Percentage of Participants Who Achieve Complete Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
2771197|NCT00730405|Secondary|The Percentage of Participants Who Achieve Mycological Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
2771198|NCT00730405|Secondary|The Percentage of Participants Who Achieve Clinical Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
2771199|NCT00730405|Primary|The Percentage of Participants Who Achieve Effective Treatment at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
2771200|NCT00730353|Secondary|Toxicity Profile|Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.|16 months||||instances of adverse event|||Number
2771201|NCT00730353|Secondary|Progression-Free Survival|To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|12 months|Intention-to-treat patients|||Days||90% Confidence Interval|Median
2771202|NCT00730353|Secondary|Overall Survival|To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma|12 months|All participants on an intent-to-treat basis|||percentage of participants||90% Confidence Interval|Median
2771203|NCT00730353|Secondary|Response Rate|To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|6 months|Evaluable patients, as previously defined.|||percentage of participants||90% Confidence Interval|Number
2771390|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Infarct Size|Measured as change in infarct size from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
2771204|NCT00730353|Primary|Progression Free Survival Rate at 24 Weeks|To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 weeks|Intent to treat - all enrolled participants|||percentage of participants||90% Confidence Interval|Number
2771205|NCT00730327|Post-Hoc|Percent Total Body Weight Loss (%TBWL)|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).|||percentage of TBWL||95% Confidence Interval|Mean
2771206|NCT00730327|Post-Hoc|Percent EWL (Using BMI=25 kg/m²)|"Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)|||percentage of EWL||Standard Deviation|Mean
2771207|NCT00730327|Post-Hoc|Change in BMI|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).|||kg/m²||Standard Deviation|Mean
2771208|NCT00730327|Secondary|Change in Participant Depression (Beck Depression Inventory II)|Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)|||units on a scale||Standard Deviation|Mean
2771209|NCT00730327|Secondary|Change in Quality of Life (IWQOL-Lite)|The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).|||units on a scale||Standard Deviation|Mean
2771210|NCT00730327|Secondary|Change in Quality of Life (SF-36)|The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.|Baseline, Week 39|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).|||units on a scale||Standard Deviation|Mean
2771211|NCT00730327|Secondary|Percent of Participants With Comorbid Conditions|"The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.~Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.~Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.~Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female)."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).|||percentage of participants|||Number
2771273|NCT00730015|Secondary|12-week Change in Severity of Straining|"Severity of Straining is measured on a 5-point scale, where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2771212|NCT00730327|Primary|Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group|"The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.~%EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.~Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table."|9 months|Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).|||percentage of BIB participants||95% Confidence Interval|Number
2771213|NCT00730327|Primary|Mean Percent Excess Weight Loss (%EWL)|"The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight."|9 months|Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).|||percentage of EWL||Standard Deviation|Mean
2771214|NCT00730275|Secondary|Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo|"Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose.~WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity."|Pre-dose through 24 hours post-dose|All participants who received a single dose of sitagliptin or placebo.|||Percent inhibition||95% Confidence Interval|Least Squares Mean
2771215|NCT00730275|Secondary|Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin|Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||hours||Standard Deviation|Mean
2771216|NCT00730275|Secondary|Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||hours||Full Range|Median
2771217|NCT00730275|Secondary|Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||nM||95% Confidence Interval|Geometric Mean
2771218|NCT00730275|Primary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin|Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||nM*hour||95% Confidence Interval|Geometric Mean
2771219|NCT00730275|Primary|Number of Participants Who Experienced at Least One Adverse Event||Pre-study through 10 to 14 days following administration of study drug|All enrolled participants.|||participants|||Number
2771220|NCT00730236|Secondary|Absolute Change From Baseline in Weight|Absolute change from Baseline in weight|Baseline and Week 78|All patients treated|||kg||Standard Deviation|Mean
2771221|NCT00730236|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and Week 78|All patients treated|||mg/dL||Standard Deviation|Mean
2771222|NCT00730236|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and Week 78|All patients treated|||U/L||Standard Deviation|Mean
2771223|NCT00730236|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and Week 78|All patients treated|||U/L||Standard Deviation|Mean
2771224|NCT00730236|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and Week 78|All patients treated|||Percent Hepatic Fat||Standard Deviation|Mean
2771225|NCT00730236|Secondary|Percent Change From Baseline in Apolipoprotein AI (Apo AI)|Percent change from Baseline in Apo AI|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
2771226|NCT00730236|Secondary|Percent Change From Baseline in Non-HDL-C|Percent change from Baseline in non-HDL-C|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
2771227|NCT00730236|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Percent change from Baseline in HDL-C|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Median
2771228|NCT00730236|Secondary|Percent Change From Baseline in Triglycerides|Percent change from Baseline in triglycerides|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
2771229|NCT00730236|Secondary|Percent Change From Baseline for Apolipoprotein B (Apo B)|Percent change from Baseline for Apo B|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
2771230|NCT00730236|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change from Baseline in TC|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
2771231|NCT00730236|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline and Week 26|Intention To Treat (ITT) Population|||Percent Change||Standard Deviation|Mean
2771312|NCT00729859|Secondary|Fasting Serum Insulin||Baseline, Day 28, Day 56|per protocol|||picomolar||Standard Deviation|Mean
2771313|NCT00729859|Secondary|Homeostasis Model of Insulin Resistance (HOMA-IR)|HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol|||HOMA score||Standard Deviation|Mean
2771232|NCT00730171|Primary|Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)|For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.|From first dose of open-label study drug up to 78 weeks|Enrolled participants who received at least 1 dose of open-label study drug. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included as an RI participant in the CC Safety Population, and as an RO participant in both the IBS-C and Overall Safety Populations.|||Participants|||Count of Participants
2771233|NCT00730158|Secondary|Circulating Tumor DNA - Percentage of Patients With DNA Mutations|Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.|End of treatment - up to 8 weeks||||percentage of participants|||Number
2771234|NCT00730158|Secondary|Circulating Tumor DNA - Percentage of Patients With DNA Mutations|Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.|Baseline - prior to treatment||||percentage of participants|||Number
2771235|NCT00730158|Secondary|Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles|The number of patients with specific polymorphisms of UGT1A1 using genotype analysis of peripheral blood sample. UGT1A1*1 is the wild-type allele associated with normal enzyme activity. Patients with genotypic status of 7/7 are at an increased risk of neutropenia following intravenous irinotecan therapy.|From 30 minutes prior to irinotecan infusion through to Immediately after irinotecan infusion, up to 8 weeks|Patients who completed at least (3) treatment cycles.|||number of participants|||Number
2771236|NCT00730158|Secondary|Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression|Number of patients with metabolites in their blood samples with a score less than 4.8 and greater than 4.8. A Cox Proportional Hazard Regression Analysis was fitted using survival time, status to the cytokines and metabolites as covariates. The analysis computes beta coefficients (hazard ratios) for each cytokine/metabolite. Scores higher than a threshold value of 4.8 were associated with higher overall survival than patients who scored less than 4.8.|Up to 36 months|Patients that received study treatment.|||participants|||Number
2771237|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index|"The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index. is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and additional concerns subscales of the FACIT-D. The TOI is an efficient summary index of physical/functional outcomes. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score can range from 0-100. Higher scores relate to better functioning."|Up to 36 months|Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).|||score on a scale||95% Confidence Interval|Mean
2771238|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score|"The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score is a 13 -item self-reporting assessment that measures fatigue related to their illness. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score ranges from 0-52. Higher scores indicate better functioning."|Up to 36 months|Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.|||score on a scale||95% Confidence Interval|Mean
2771239|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)|"The FACIT-D FACTG: FACT-G Total Score is a total of PWB (Physical Well-Being)+SWB (Social Well-Being)+EWB (Emotional Well-Being)+FWB (Functional Well-Being) subset scores. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score ranges from 0-108. Higher scores indicate greater well-being."|Up to 36 months|Maximum number of participants that completed the FACT-G during any single treatment cycle.|||score on a scale||95% Confidence Interval|Mean
2771240|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being|"The Functional Assessment of Chronic Illness Therapy FACIT-D Functional Well-Being (FWB) is a 7-item subscale of the FACIT-D that measures a patient's functional well-being. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score ranges from 0-28. Higher scores related to better family well-being."|Up to 36 months|Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.|||score on a scale||95% Confidence Interval|Mean
2771241|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being|"The Functional Assessment of Chronic Illness Therapy FACIT-D Social Well-Being (SWB) is a 7-item subset score of the total FACIT-D self-assessment that measures a patient's social well-being. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score ranges from 0-28. Higher scores related to better social well-being."|Up to 36 months|Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.|||score on a scale||95% Confidence Interval|Mean
2771242|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being|"The Functional Assessment of Chronic Illness Therapy FACIT-D Emotional Well-Being (EWB) is a 6-item subscale score of the total FACIT-D self-assessment that measures a patient's emotional well-being. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score ranges from 0-24. Higher scores related to better emotional well-being."|Up to 36 months|Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle (every 2 weeks).|||score on a scale||95% Confidence Interval|Mean
2771391|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction|Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
2771243|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being|"The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being is a 7-item subscale score of the total FACIT-D self-assessment that measures a patient's physical well-being. Individual responses are scale and range from 0 = Not at all to 4 = Very Much. The total score ranges from 0-28. Higher scores related to better physical well-being."|Up to 36 months|Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.|||score on a scale||95% Confidence Interval|Mean
2771244|NCT00730158|Secondary|The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score|"The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Functional Assessment of Chronic Illness Therapy (Diarrhea), the FACIT-D, contains 11 items which address concerns related to treatment-related diarrhea. Responses are on a Likert scale and range from 0 = Not at all to 4 = Very Much. Thus, total scores can range from 0 to 44. Higher scores relate to better functioning."|Up to 36 months|Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).|||score on a scale||95% Confidence Interval|Mean
2771245|NCT00730158|Secondary|Clinical Response (CR)|Number of patients that experienced Progressed Disease, Stable Disease or Partial Response per RECIST 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters, and Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 36 months|Participants that were evaluable for response.|||participants|||Number
2771246|NCT00730158|Secondary|Overall Survival (OS)|Median number of days from the start of treatment that study participants remained alive.|Up to 900 days|All participants.|||Days||95% Confidence Interval|Median
2771247|NCT00730158|Secondary|Progression-free Survival (PFS)|"Median number of days and after the treatment participants remained alive without worsening disease.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|Up to 450 days|Patients that were evaluable for response and survival data were obtainable.|||Days||95% Confidence Interval|Median
2771248|NCT00730158|Secondary|Overall Response (OR)|Number of participants who experienced a best response of Partial Response (PR) or Stable Disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), PR is >=30% decrease in the sum of the longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameter.|Up to 36 months|Participants evaluable for response.|||participants|||Number
2771249|NCT00730158|Primary|Proportion of Participants With Grade 2-4 Toxicities|The proportion of participants with a toxicity grade greater than or equal to grade 2, per NCI CTCAE 4.0. Toxicity is defined as any adverse event (AE) at least probably related to treatment occurring with 90 days of the beginning of treatment. The worst grade of AE at least probably related to treatment was determined for each participant.|Up to 3 months after start of study treatment|Participants that received at least 3 months of study treatment.|||proportion of participants||95% Confidence Interval|Number
2771250|NCT00730132|Primary|Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||mmol/L||Standard Deviation|Mean
2771251|NCT00730132|Primary|Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||mmol/L||Standard Deviation|Mean
2771252|NCT00730132|Primary|Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation||Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded.|||Percentage of patients|||Number
2771253|NCT00730132|Primary|Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation|Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||Percentage of patients|||Number
2771314|NCT00729859|Secondary|Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol|||QUICKI index||Standard Deviation|Mean
2771254|NCT00730132|Primary|Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.|Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|During the study|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data)|||Percentage of patients|||Number
2771255|NCT00730041|Secondary|Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)|The CPAP machine has an internal clock/calendar, and capabilities to record usage onto a removable data card the size of a credit card. Data is recorded from the first time the machine is turned on to the last time the machine is turned on during a given period in which the SmartCard is present in the machine. The SmartCard records all days during the given period and keeps track of days in which the CPAP machine is used and days in which it is not used. The SmartCard data is able to be downloaded to a computer for review and analysis.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.|||Average hours per day of days used||Standard Deviation|Mean
2771256|NCT00730041|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.|The FOSQ can assess the quality of sleep and this scale is a validated measure the impact of excessive sleepiness on multiple activities of daily living. It has 30 questions in 5 subgroups of general productivity (8 questions), social outcome (2), activity level (9), vigilance (7), and intimate relationships and sexual activity (4). Responses for each question range from 1 (extreme difficulty or low activity level) to 4 (no difficulty or high activity level) for each subgroup. A mean is calculated for each subgroup, and then the mean of the subgroups is calculated and multiplied by 5.|Baseline and 4 months post-procedure|Two subjects became lost to follow-up and did not return for the final study visit.|||Scores on a Scale||Standard Deviation|Mean
2771257|NCT00730041|Secondary|Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.|The Epworth Sleepiness Scale (ESS) was included in the subject questionnaire as a tool to further assess the quality of sleep for each subject throughout the follow-up period. This scale is a validated clinical indicator that quantifies the patient's chance of falling asleep during eight different activities of daily living such as reading, talking, resting and driving. Each of the eight questions has four possible responses: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing to 3 = high chance of dozing, for a possible maximum score of 24.|Baseline and 4 months post-procedure|Two participants became lost to follow-up and did not return for the final study visit.|||Scores on a Scale||Standard Deviation|Mean
2771258|NCT00730041|Secondary|Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP satisfaction. Scores ranged from 0 (very unsatisfied) to 10 (very satisfied).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.|||Scores on a Scale||Standard Deviation|Mean
2771259|NCT00730041|Secondary|Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)|Leak is an indicator of mask/headgear fit and can also be used to substantiate or contradict an assigned therapeutic pressure. Total leak is the sum of intentional leak to prevent carbon dioxide rebreathing and unintentional leak. Each mask has a known amount of leak (the intentional leak), and subjects were instructed not to changes masks to minimize this variable. Approximate range is 0-100, and the amount of leak increases as the number increases. Average leak values are in the 20-50 liters per minute range. The CPAP machine records leak data during each night of usage and can average.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.|||Units on a scale||Standard Deviation|Mean
2771260|NCT00730041|Secondary|Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP therapy comfort. Scores ranged from 0 (very uncomfortable) to 10 (very comfortable).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.|||Scores on a Scale||Standard Deviation|Mean
2771261|NCT00730041|Primary|Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration|The American Academy of Sleep Medicine's (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.|Baseline and 3 months post-procedure|50 of 51 total participants returned to the sleep lab for the 90-day PSG. All 50 participants are part of the primary endpoint analysis.|||centimeters of water (cm H2O)||Standard Deviation|Mean
2771262|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|All participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
2771315|NCT00729859|Secondary|Sex Hormone Binding Globulin (SHBG)||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||nmol/L||Standard Deviation|Mean
2771316|NCT00729859|Secondary|Estradiol Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||pmol/L||Standard Deviation|Mean
2771263|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.|||percentage of participants||95% Confidence Interval|Number
2771264|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|All participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
2771265|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.|||percentage of participants||95% Confidence Interval|Number
2771266|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The ITT population was comprised of all participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
2771267|NCT00730028|Secondary|Number of Participants Reporting Adverse Events That Are Treatment Limiting.|Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.|||participants|||Number
2771268|NCT00730028|Secondary|Number of Participants Reporting Adverse Events.|Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.|||participants|||Number
2771269|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.|||percentage of participants||95% Confidence Interval|Number
2771270|NCT00730015|Secondary|12-week Change in Constipation Severity|"Constipation severity was based on a 5-point ordinal scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2771271|NCT00730015|Secondary|12-week Change in Bloating|"Bloating was based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2771272|NCT00730015|Secondary|12-week Change in Abdominal Discomfort|"Abdominal discomfort is based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2771274|NCT00730015|Secondary|12-week Change in Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
2771275|NCT00730015|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The number of SBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per Week||Standard Error|Least Squares Mean
2771276|NCT00730015|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The number of CSBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
2771277|NCT00730015|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
2771278|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771279|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771280|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.|||days||Standard Deviation|Mean
2771281|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||days||Standard Deviation|Mean
2771282|NCT00729937|Secondary|Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class|All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771283|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771317|NCT00729859|Secondary|Testosterone Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.|||nmol/L||Standard Deviation|Mean
2771318|NCT00729859|Secondary|Luteinizing Hormone Concentration (LH)||Baseline, Day 28|The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.|||IU/L||Standard Deviation|Mean
2771284|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771285|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771286|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771287|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771288|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771289|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771290|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771291|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771292|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771293|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771319|NCT00729859|Secondary|Follicle Stimulating Hormone (FSH)||Baseline, 28 days|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||IU/L||Standard Deviation|Mean
2771320|NCT00729859|Primary|Endothelial Progenitor Cells|Number of CD33 + CD134+ cells as a percentage of all lymphocytes|Baseline, Day 28|Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed|||percentage of all lymphocytes||Standard Deviation|Mean
2771294|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771295|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771296|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771297|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771298|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771299|NCT00729937|Secondary|Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771300|NCT00729937|Secondary|Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771301|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771321|NCT00729846|Primary|Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.||1 Year||||percent of participants|||Number
2771650|NCT00727857|Secondary|Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration|The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
2771302|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771303|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771304|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771305|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771306|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771307|NCT00729937|Primary|Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
2771308|NCT00729937|Secondary|Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
2771309|NCT00729924|Secondary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.|This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).|Day 7||||ratio||Inter-Quartile Range|Median
2771310|NCT00729924|Primary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.|The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).|Day 7||||1/h||Inter-Quartile Range|Median
2771311|NCT00729859|Secondary|Fasting Lipid Levels||Baseline, Day 28, Day 56|per protocol|||mmol/L||Standard Deviation|Mean
2771322|NCT00729833|Secondary|Number of Participants With Objective Response (OR)|Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2771323|NCT00729833|Secondary|Number of Participants With Anti-Drug Antibodies (ADA)|Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.|0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)|ADA Analysis Set: Participants who started treatment with study medication and provided at least 1 on-study ADA sample. Due to early termination of the study, ADA samples were not assayed.||||||
2771324|NCT00729833|Secondary|Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib||24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2771325|NCT00729833|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib||0.5 hour predose on Day 1 of Cycle 2|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2771326|NCT00729833|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib|AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).|0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2771327|NCT00729833|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||hours||Full Range|Median
2771328|NCT00729833|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2771329|NCT00729833|Secondary|Plasma Decay Half-Life (t1/2) of Figitumumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||hours||Standard Deviation|Mean
2771330|NCT00729833|Secondary|Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab|AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2771331|NCT00729833|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||milligram*hour/milliliter (mg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2771332|NCT00729833|Secondary|Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab||0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4|Pharmacokinetic (PK) Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||milligram/liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2771333|NCT00729833|Secondary|Percentage of Participants With Blood Chemistry Laboratory Test Abnormality|Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication; n=number of participants evaluable for this outcome measure, respectively.|||percentage of participants|||Number
2771334|NCT00729833|Secondary|Percentage of Participants With Hematologic Laboratory Test Abnormality|Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2775501|NCT00703664|Secondary|Progression-free Survival (PFS)|Median progression-free survival in months per cohort.|Up to 9 years|All evaluable participants at time of analysis. Cohort B was closed early due to lack of accrual.|||months||95% Confidence Interval|Median
2771335|NCT00729833|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2771336|NCT00729833|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|"Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2.~Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Baseline up to the end of Cycle 1 (each cycle=3 weeks)|Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.|||participants|||Number
2771337|NCT00729807|Secondary|Time to Progression|"Radiologic intervention using RECIST (x-ray, CT, MRI)~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Every 8 weeks, assesed up to 6 months|Only data for 1 site was analyzed for this outcome measure.|||days||Full Range|Median
2771338|NCT00729807|Secondary|Number of Participants With Serious and Non Serious Adverse Events|Metabolic Panel, Physical Exam, Vitals|Up to 6 months||||Participants|||Count of Participants
2771339|NCT00729807|Secondary|Expression of S100B|Serum for S100B level|Cycle 1 Day 8, Cycle 1 Day 12, Cycle 2 Day 8, Cycle 2 Day 12|Only data from 1 site was analyzed for this outcome measure|||pg/ml||Full Range|Median
2771340|NCT00729807|Secondary|Expression of S100B Pre Pentamidine Exposure|Serum for S100B|Pre-Study|Only data for 1 site was analyzed for this outcome measure.|||pg/ml||Full Range|Median
2771341|NCT00729807|Secondary|Number of Participants With p21 and S100B Expression in Accessible Tumor Biopsies Post Pentamidine Exposure|Core needle tumor biopsy - at Day 12 at first cycle of treatment|Day 12 Cycle 1|Only 1 participant from 1 site had a biopsy collected and analyzed|||Participants|||Count of Participants
2771342|NCT00729807|Secondary|Number of Participants With Both p21 and S100B Expression in Accessible Tumor Biopsies Pre Pentamidine Exposure in Cycle 1|Core Needle Tumor Biopsy|Pre-Study, an average of 12 days|Only data for 1 site was analyzed for this outcome measure|||Participants|||Count of Participants
2771343|NCT00729807|Primary|Response Rate in Patients Treated With Pentamidine|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months|Six participants analyzed.|||Participants|||Count of Participants
2771344|NCT00729781|Primary|Safety|Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.|During 12-week original study and at long-term follow-up of 11 months or longer|All enrolled subjects' adverse events were collected.|||events|||Number
2771345|NCT00729781|Primary|Cosmetic Improvement|"An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from Worse to Very much improved). If the post-treatment photograph was not correctly identified, that procedure will receive a worse on the rating scale."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.|||participants|||Number
2771346|NCT00729781|Primary|Functional Improvement|"Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from Not a problem to Severe problem, possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.|||participants|||Number
2771347|NCT00729690|Secondary|Passive Knee Flexion|Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).|PostOp day 2|All Completed Patients were used|||Degrees||Standard Deviation|Mean
2771348|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 12 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|12 hours Post dose|All Completed Patients|||Area (NRS*hr)||Standard Deviation|Mean
2771350|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 24 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|24 hours|All Completed Patients were included in the analysis.|||Area (NRS*hr)||Standard Deviation|Mean
2771351|NCT00729677|Post-Hoc|Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy|Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.|Week 1||||participants|||Number
2771352|NCT00729677|Primary|Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy|Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy|week 1||||participants|||Number
2771353|NCT00729677|Primary|Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index - Emesis Scale at 5-7 Days|Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.|Week 1|this data was not collected||||||
2771354|NCT00729677|Primary|Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy||Week 1 of FOLFOX chemotherapy||||percentage of participants|||Number
2771355|NCT00729651|Post-Hoc|Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||ng/ml||Standard Deviation|Mean
2771356|NCT00729651|Post-Hoc|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||participants|||Number
2771357|NCT00729651|Secondary|Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment||Baseline and 16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||Percentage Change Serum PTH||95% Confidence Interval|Least Squares Mean
2771358|NCT00729651|Primary|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||participants|||Number
2771359|NCT00729612|Secondary|Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0|The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics|Up to 5 years|Grade 3 and 4|||patients|||Number
2771360|NCT00729612|Secondary|Overall Survival|Will be analyzed using a Kaplan-Meier methods.|Up to 5 years||||months||95% Confidence Interval|Median
2771361|NCT00729612|Secondary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 5 years||||months||95% Confidence Interval|Median
2771362|NCT00729612|Primary|Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.|Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
2771363|NCT00729586|Other Pre-specified|Number of Participants and Their Levels of Expression of the Candidate Markers|The levels of expression of the candidate markers measured prior to study treatment are tabulated. The expressions being tabulated include immunohistochemical expression of hormone receptors. The hormone receptors are estrogen receptor positive, progesterone receptors-A, progesterone receptor-B, PAKT Positive and PTEN Positive. The associations between the immunohistochemical expression of these biomarkers and between these biomarkers and treatment, outcome or clinical characteristics are reported for future investigation.|Baseline|Eligible and treated patients with primary tumor specimen|||participants|||Number
2771364|NCT00729586|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment.|Eligible and treated patients|||Participants|||Count of Participants
2771365|NCT00729586|Secondary|Duration of Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions.|Radiologic tumor evaluations at baseline and every six weeks for the first 24 weeks and then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.|Eligible and treated patients|||months||95% Confidence Interval|Median
2771366|NCT00729586|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every 6 weeks during treatment, then every 3 months for one year.|Eligible and treated patients|||months||95% Confidence Interval|Median
2771659|NCT00727857|Secondary|Change From Baseline in Large Low Density Lipoprotein (L3) Concentration|The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771367|NCT00729586|Primary|Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.|Eligible and treated patients|||percentage of participants||94% Confidence Interval|Number
2771368|NCT00729560|Primary|DCI-IPG Measurements in Blood and Urine|zero participants analyzed, no assays performed|2 years|||||||
2771369|NCT00729521|Primary|Emergency Department and In-patient Hospitalization for Fall Injury|Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.|2007-2008; 2010-2011|Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.|||Fall Injury Rate per 100 person years||95% Confidence Interval|Number
2771370|NCT00729482|Secondary|Number of Participants With Adverse Events|(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)|up to 24 weeks||||participants|||Number
2771371|NCT00729482|Secondary|Overall Survival||1 year||||Months||95% Confidence Interval|Median
2771372|NCT00729482|Secondary|Response Rate|Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.|2years|51 patients were available for response assessments.|||percentage of participants|||Number
2771373|NCT00729482|Primary|Progression-free Survival Rate at 4-month (16 Weeks)|progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion|4 months (16 weeks)||||percentage of participants|||Number
2771374|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
2771375|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
2771376|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.|||participants|||Number
2771377|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)||4 weeks|ITT|||pH||Standard Deviation|Mean
2771378|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.|||participants|||Number
2771379|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)||4 weeks|ITT|||pH||Standard Deviation|Mean
2771380|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||12 weeks|ITT; LOCF|||participants|||Number
2771381|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)||12 weeks|ITT; LOCF|||pH||Standard Deviation|Mean
2771382|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)||12 weeks|ITT; LOCF|||percentage of superficial cells||Standard Deviation|Mean
2771383|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)||12 weeks|ITT; LOCF|||percentage of parabasal cells||Standard Deviation|Mean
2771384|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||12 weeks|ITT; LOCF|||participants|||Number
2771385|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
2771386|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
2771387|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)||12 weeks|ITT; LOCF|||pH||Standard Deviation|Mean
2771392|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis|Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
2771393|NCT00729430|Primary|Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling|Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)|Before and after study treatments||||Percent Change||Standard Deviation|Mean
2771394|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Tibia 66% Site|Baseline to 24-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
2771395|NCT00729378|Primary|24-month Change in Cortical Thickness at the Tibia 66% Site|Baseline to 24-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771396|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 66% Site|Baseline to 24-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771397|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771398|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771399|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 66% Site|Baseline to 24-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771400|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Tibia 50% Site|Baseline to 24-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
2771401|NCT00729378|Primary|24-month Change in Cortical Thickness at the Tibia 50% Site|Baseline to 24-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771402|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 50% Site|Baseline to 24-month measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771651|NCT00727857|Secondary|Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration|The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
2771403|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771404|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771405|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 50% Site|Baseline to 24-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771406|NCT00729378|Primary|24-month Change in Bone Strength Index at the Tibia 4% Site|Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
2771407|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 4% Site|Baseline to 24-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771408|NCT00729378|Primary|24-month Change in Cortical Bone Area at the Tibia 4% Site|Baseline to 24-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771409|NCT00729378|Primary|24-month Change in Trabecular Bone Area at the Tibia 4% Site|Baseline to 24-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771410|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771411|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771412|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 4% Site|Baseline to 24-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771652|NCT00727857|Secondary|Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration|The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
2771413|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Femur 20% Site|Baseline to 24-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
2771414|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Femur 20% Site|Baseline to 24-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771415|NCT00729378|Primary|24-month Change in Thickness of Cortical Bone at the Femur 20% Site|Baseline to 24-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771416|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771417|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771418|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Femur 20% Site|Baseline to 24-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771419|NCT00729378|Primary|24-month Change in Bone Strength Index at the Femur 4% Site|Baseline to 24-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
2771420|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Femur 4% Site|Baseline to 24-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771421|NCT00729378|Primary|24-month Change in Cortical Bone Area at the Femur 4% Site|Baseline to 24-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771422|NCT00729378|Primary|24-month Change in Trabecular Bone Area at the Femur 4% Site|Baseline to 24-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771653|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Size|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Error|Least Squares Mean
2771423|NCT00729378|Primary|24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771424|NCT00729378|Primary|24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771425|NCT00729378|Primary|24-month in Change in Total Volumetric Bone Density the Femur 4% Site|Baseline to 24-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units mg/ccm.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771426|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Tibia 66% Site|Baseline to 12-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
2771427|NCT00729378|Primary|12-month Change in Cortical Thickness at the Tibia 66% Site|Baseline to 12-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771428|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 66% Site|Baseline to 12-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771429|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771430|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771431|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 66% Site|Baseline to 12-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771432|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Tibia 50% Site|Baseline to 12-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
2771433|NCT00729378|Primary|12-month Change in Cortical Thickness at the Tibia 50% Site|Baseline to 12-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771434|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 50% Site|Baseline to 12-month change in periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771435|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771436|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771437|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 50% Site|Baseline to 12-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771438|NCT00729378|Primary|12-month Change in Bone Strength Index at the Tibia 4% Site|Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
2771439|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 4% Site|Baseline to 12-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771440|NCT00729378|Primary|12-month Change in Cortical Bone Area at the Tibia 4% Site|Baseline to 12-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771441|NCT00729378|Primary|12-month Change in Trabecular Bone Area at the Tibia 4% Site|Baseline to 12-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771442|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771506|NCT00729326|Secondary|Change in Postprandial Glucagon AUC Excursion After the Morning Meal|Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
2771443|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771444|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 4% Site|Baseline to 12-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771445|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Femur 20% Site|Baseline to 12-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
2771446|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Femur 20% Site|Baseline to 12-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771447|NCT00729378|Primary|12-month Change in Thickness of Cortical Bone at the Femur 20% Site|Baseline to 12-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771448|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771449|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771450|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Femur 20% Site|Baseline to 12-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771451|NCT00729378|Primary|12-month Change in Bone Strength Index at the Femur 4% Site|Baseline to 12-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
2771452|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Femur 4% Site|Baseline to 12-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
2771654|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Concentration|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
2771453|NCT00729378|Primary|12-month Change in Cortical Bone Area at the Femur 4% Site|Baseline to 12-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771454|NCT00729378|Primary|12-month Change in Trabecular Bone Area at the Femur 4% Site|Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
2771455|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771456|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771457|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density the Femur 4% Site|Baseline to 12-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771458|NCT00729378|Primary|Baseline Stress-Strain Index at the Tibia 66% Site|Baseline (initial) measurement of strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
2771459|NCT00729378|Primary|Baseline Cortical Thickness at the Tibia 66% Site|Baseline (initial) measurement of cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771460|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 66% Site|Baseline (initial) measurement of periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771461|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771462|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771463|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 66% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771655|NCT00727857|Secondary|Change From Baseline in Very Small Low Density Lipoprotein Concentration|The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771464|NCT00729378|Primary|Baseline Stress-Strain Index at the Tibia 50% Site|Baseline (initial) measurement of stress-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
2771465|NCT00729378|Primary|Baseline Cortical Thickness at the Tibia 50% Site|Baseline (initial) measurement of cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771466|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 50% Site|Baseline (initial) measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771467|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771468|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771469|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 50% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771470|NCT00729378|Primary|Baseline Bone Strength Index at the Tibia 4% Site|Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^4||Standard Deviation|Mean
2771471|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 4% Site|Baseline (initial) measurement of periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771472|NCT00729378|Primary|Baseline Cortical Bone Area at the Tibia 4% Site|Baseline (initial) measurement of cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
2771473|NCT00729378|Primary|Baseline Trabecular Bone Area at the Tibia 4% Site|Baseline (initial) measurement of trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
2771474|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771475|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 4% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771656|NCT00727857|Secondary|Change From Baseline in Small Low Density Lipoprotein Concentration|The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771476|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771477|NCT00729378|Primary|Baseline Stress-Strain Index at the Femur 20% Site|Baseline (initial) measurement of stress-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
2771478|NCT00729378|Primary|Baseline Cortical Thickness at the Femur 20% Site|Baseline (initial) measurement of cortical thickness at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771479|NCT00729378|Primary|Baseline Periosteal Circumference at the Femur 20% Site|Baseline (initial) measurement of periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771480|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771481|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771482|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Femur 20% Site|Baseline (initial) measurement of total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771483|NCT00729378|Primary|Baseline Bone Strength Index at the Femur 4% Site|Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^4||Standard Deviation|Mean
2771484|NCT00729378|Primary|Baseline Periosteal Circumference at the Femur 4% Site|Baseline (initial) measurement of periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
2771485|NCT00729378|Primary|Baseline Cortical Bone Area at the Femur 4% Site|Baseline (initial) measurement of cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
2771486|NCT00729378|Primary|Baseline Trabecular Bone Area at the Femur 4% Site|Baseline (initial) measurement of trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
2771487|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771657|NCT00727857|Secondary|Change From Baseline in Medium-Small Low Density Lipoprotein Concentration|The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771488|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771489|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Femur 4% Site|Baseline (initial) measurement of total volumetric bone density at the femur 4% site. Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
2771490|NCT00729365|Secondary|We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.||year 1, 3, 5 and after the washout phase (5years and 1month)|||||||
2771491|NCT00729365|Primary|Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.||at 3months and then every 6months during the 5years of the study|||||||
2771492|NCT00729326|Secondary|Episodes of Hypoglycemia (Overall)|Number of episodes of hypoglycemia experienced overall during the study|4 weeks and 8 weeks|All patients in FAS|||episodes of hypoglycemia|||Number
2771493|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Overall)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 weeks and 8 weeks|All patients in FAS|||Percentage of patients|||Number
2771494|NCT00729326|Secondary|Episodes of Hypoglycemia (Week 4 to Week 8)|Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study|8 weeks|All patients in FAS|||episodes of hypoglycemia|||Number
2771495|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|8 weeks|All patients in FAS|||Percentage of patients|||Number
2771496|NCT00729326|Secondary|Episodes of Hypoglycemia (Baseline to Week 4)|Number of episodes of hypoglycemia experienced during the first 4 weeks of the study|4 weeks|Full analysis set|||episodes of hypoglycemia|||Number
2771497|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 Weeks|All patients in FAS|||Percentage of patients|||Number
2771498|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal|Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
2771499|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC After the Morning Meal|Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
2771500|NCT00729326|Secondary|Change in Postprandial Insulin AUC Excursion After the Morning Meal|Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
2771501|NCT00729326|Secondary|Change in Postprandial Insulin AUC After the Morning Meal|Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
2771502|NCT00729326|Secondary|Change in Postprandial C-peptide AUC Excursion After the Morning Meal|Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||nmol*hours/L||Standard Error|Least Squares Mean
2771503|NCT00729326|Secondary|Change in Postprandial C-peptide AUC After the Morning Meal|Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||nmol*hours/L||Standard Error|Least Squares Mean
2771504|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC Excursion After the Morning Meal|Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||mg*hours/dL||Standard Error|Least Squares Mean
2771505|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC After the Morning Meal|Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||mg*hours/dL||Standard Error|Least Squares Mean
2771507|NCT00729326|Secondary|Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal|Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
2771508|NCT00729326|Secondary|Change in Fasting Blood Glucose After the Morning Meal|Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
2771509|NCT00729326|Secondary|Change in Two-hour Postprandial Glucose After the Morning Meal|Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
2771510|NCT00729326|Primary|Change in Time-averaged Glucose During a 24 Hour Period|Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).|baseline and 8 Weeks|The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.|||mg/dL||Standard Error|Least Squares Mean
2771511|NCT00729248|Primary|CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors|CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and > 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and > 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.|3 months|For each arm, blood samples from 5 donor/recipient pairs (i.e., 10 participants) were used.|||Percentage of Control Cells||Standard Deviation|Mean
2771512|NCT00729183|Secondary|Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. s-P1NP was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. s-P1NP was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|PP population: All participants receiving at least one dose of study treatment and with available s-P1NP data, excluding participants with important deviations from the protocol that may have substantially affected the results.|||percent change||95% Confidence Interval|Least Squares Mean
2771513|NCT00729183|Secondary|Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. s-CTx was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. S-CTx was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|Per-Protocol (PP) population: All participants receiving at least one dose of study treatment and with available s-CTx data, excluding participants with important deviations from the protocol that may have substantially affected the results.|||percent change||95% Confidence Interval|Least Squares Mean
2771514|NCT00729183|Secondary|Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)|Trabecular vBMD at the lumbar spine (L2) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L2) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L2) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L2) baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771515|NCT00729183|Secondary|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)|Trabecular vBMD at the lumbar spine (L1) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L1) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L1) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L1) baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771534|NCT00729053|Secondary|Overall Survival at 1 Year|Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.|From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.|ITT Population|||Participants|||Count of Participants
2775782|NCT00701805|Secondary|Change in Mean iPTH||Every week from Baseline through Week 13 and every other week thereafter until Week 53|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||pg/mL||Standard Deviation|Mean
2771516|NCT00729183|Secondary|Percent Change From Baseline in Distal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the one-third distal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the distal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization distal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having distal radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771517|NCT00729183|Secondary|Percent Change From Baseline in Ultradistal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the ultradistal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the ultradistal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization ultradistal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having ultradistal radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771518|NCT00729183|Secondary|Percent Change From Baseline in Total Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the total radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total radius aBMD endpoint data subsequent to at least one dose of study treatment, and having total radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771519|NCT00729183|Secondary|Percent Change From Baseline in Hip Trochanter aBMD|aBMD (g/cm^2) data was measured by DXA at the hip trochanter. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the hip trochanter was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization hip trochanter aBMD endpoint data subsequent to at least one dose of study treatment, and having hip trochanter aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771520|NCT00729183|Secondary|Percent Change From Baseline in Femoral Neck aBMD|aBMD (g/cm^2) data was measured by DXA at the femoral neck (hip). All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the femoral neck was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization femoral neck aBMD endpoint data subsequent to at least one dose of study treatment, and having femoral neck aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771521|NCT00729183|Secondary|Percent Change From Baseline in Total Hip aBMD|aBMD (g/cm^2) data was measured by DXA at the total hip. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total hip was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total hip aBMD endpoint data subsequent to at least one dose of study treatment, and having total hip aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771522|NCT00729183|Secondary|Percent Change From Baseline to Month 24 in Lumbar Spine aBMD|aBMD (g/cm^2) was measured by DXA at the lumbar spine and mean BMD measurements from at least 3 evaluable vertebrae from L1 through L4 were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 24 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
2771523|NCT00729183|Primary|Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.|||percentage of participants|||Number
2771524|NCT00729183|Primary|Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|All-Participants-as-Treated (APaT) population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.|||percentage of participants|||Number
2771525|NCT00729183|Primary|Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)|aBMD (g/cm^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 12 months|Full-Analysis-Set (FAS) population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 12 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline (BL) data.|||percent change||95% Confidence Interval|Least Squares Mean
2771526|NCT00729157|Other Pre-specified|To Determine if Changes in Thyroglobulin Concentration After Four Cycles (Approximately 8 Weeks) of IV VEGF-Trap Therapy Correlate With Radiographic Response After Four Cycles (Approximately 8 Weeks)|This part is currently under data analysis, therefore, this outcome measure has not been calculated|8 weeks|||||||
2771527|NCT00729157|Other Pre-specified|To Determine if Pre-treatment Serum VEGF Concentration Correlates With Clinical Outcomes After IV VEGF Trap Therapy in Patients With Recurrent and/or Metastatic D-TC-FCO.|This part is currently under data analysis, therefore, this outcome measure has not been calculatedThis part is currently under data analysis, therefore, this outcome measure has not been calculated.|Baseline-6 months post treatment|||||||
2771528|NCT00729157|Secondary|Effect of Thyroglobulin Concentration on Progression-free Survival|The change is serum thyroglobulin was measured by the percent change between the baseline value and the lowest value obtained while on treatment.|6 months||||percent change serum thyroglobulin||Full Range|Median
2771529|NCT00729157|Secondary|To Determine the Biologic Effect of IV VEGF Trap on FDG Avidity After Four Cycles (Approximately 8 Weeks) of Therapy Through Pre- and Post-treatment FDG-PET Scans in Patients With Recurrent and/or Metastatic D-TC-FCO.|To determine the biologic effect of IV VEGF Trap on FDG avidity after four cycles (approximately 8 weeks) of therapy through pre- and post-treatment FDG-PET scans in patients with recurrent and/or metastatic D-TC-FCO.|8 weeks||||percent of SUVm change||95% Confidence Interval|Median
2771530|NCT00729157|Secondary|The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO|The number of participants, with recurrent and/or metastatic TC-FCO, who experienced adverse events. Please see the adverse event table for the specifics for this protocol.|From the beginning of treatment through 30 days until participant comes off study||||participants|||Number
2771531|NCT00729157|Primary|Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions & assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + P RMeasurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT, MRI, x-ray) or as ≥ 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions (or sites of disease), including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), & cystic|After 8 weeks of study therapy||||participants|||Number
2771532|NCT00729157|Primary|Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate|Progression-free survival to determine the 6-month progression-free-survival (PFS) rate|6 months||||months||95% Confidence Interval|Median
2771533|NCT00729053|Secondary|Time to Disease Progression.|Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.|Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression|ITT Population|||Days||95% Confidence Interval|Median
2771535|NCT00729053|Secondary|Duration of Response by RECIST v1.0|Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.|Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.|Participants with reported response as reflected in Outcome Measure 1|||Days|||Number
2771536|NCT00729053|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity|Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.|From start of treatment through one month after the end of study visit (up to 28 weeks)|Safety Population|||Participants|||Count of Participants
2771537|NCT00729053|Primary|Best Response by RECIST v1.0|Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.|From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.|ITT Population|||Participants|||Count of Participants
2771538|NCT00728988|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents.|Baseline, 8 hours, 24 hours and 30 days|FAS. N = number of subjects with non-missing values at baseline.|||percent change in CRP||Standard Error|Least Squares Mean
2771539|NCT00728988|Secondary|Percentage of Participants With Elevated Myoglobin|Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
2771540|NCT00728988|Secondary|Percentage of Participants With Elevated Troponin I|Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
2771541|NCT00728988|Secondary|Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)|CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
2771542|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.|24 hours post PCI|FAS.|||percentage of participants|||Number
2771543|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.|8 hours post PCI|FAS.|||percentage of participants|||Number
2771544|NCT00728988|Primary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)|Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.|30 days post PCI|Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).|||percentage of participants|||Number
2771545|NCT00728962|Secondary|Crestal Bone Regression||four years|||||||
2771546|NCT00728962|Primary|Patients With Implants Achieving Osseous Integration|Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|1 year|total number of patients enrolled in the study was used for primary outcome analysis|||participants|||Number
2771547|NCT00728949|Primary|Overall Survival (OS)|OS is defined as the interval between date of randomization and the date of death due to any cause. Participants who are alive at the time of study completion will be censored at the time the participants was last known to be alive.|From randomization up to 36.5 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||months||90% Confidence Interval|Median
2771548|NCT00728949|Secondary|Changes in Circulating Tumor Cell Counts (CTS)||Approximately 24 months|Zero participants analyzed. Circulating tumor cell counts were not collected for analysis.||||||
2771549|NCT00728949|Secondary|Number of Participants Experiencing Adverse Events (AEs) in National Cancer Institute Common Toxicity Criteria for AE's (NCI-CTCAE) Version 3.0 Criteria for Adverse Events (NCI-CTCAE)|The NCI-CTCAE provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Severity will be graded as mild (grade 1), moderate (grade 2), severe (grade 3), or very severe (life threatening - grade 4). Clinically significant events were defined as serious and other non-serious adverse events related to study drug regardless of causality. A summary of serious and other non-serious adverse events is located in the Reported Adverse Event module.|Randomization to End of Study up to 36.5 Months|Safety population: All participants who received actual treatment of any drug. There is a difference of 6 participants for treatment groups of IMC-A12 (Cixutumumab) + Antiestrogen and IMC-A12 (Cixutumumab) of ITT population and Safety population due to planned treatment (based on randomization) differed from actual treatment.|||Participants|||Count of Participants
2771660|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Size|The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Deviation|Least Squares Mean
2771550|NCT00728949|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) or Stable Disease (SD) Disease Control Rate [DCR])|DCR is defined as percentage of participants with CR, PR, or SD using RECIST v 1.0 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Randomization to PD up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment. Number of participants censored = 15 Cixutumumab + antiestrogen, 5 Cixutumumab only|||percentage of participants||95% Confidence Interval|Number
2771551|NCT00728949|Secondary|12-Month Survival Rate|The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.|From randomization to until the date of first documented date of death from any cause within 12 months, assessed up to 35.1 months|Intent-to-treat (ITT) population: All randomized participants who receive any drug.|||percentage of participants||90% Confidence Interval|Number
2771552|NCT00728949|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|Best overall response of CR or PR was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of longest diameter (SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Randomization to PD up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||percentage of participants||95% Confidence Interval|Number
2771553|NCT00728949|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions unequivocal progression of non-target lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS will be estimated following the Kaplan-Meier method.|From randomization up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||months||90% Confidence Interval|Median
2771554|NCT00728936|Primary|Evaluation of Safety.|Count and percentage of subjects with treatment emergent adverse events|From screening through study completion, 86 to 115 days in total|Safety population|||Participants|||Count of Participants
2771555|NCT00728923|Secondary|Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.|Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D.|12 weeks||||participants|||Number
2771556|NCT00728923|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS.|12 weeks||||participants|||Number
2771557|NCT00728910|Primary|Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)|Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)|4 weeks, 12 weeks, 22 weeks|subjects completing any phase of treatment for whom complete post-prandial data were available|||mg/dl*h||95% Confidence Interval|Mean
2771558|NCT00728910|Primary|Apo-A1 Production Rate|The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.|4 weeks, 12 weeks and 22 weeks|Patients who completed any phase of treatment for whom kinetic data were available|||mg/kg/day||95% Confidence Interval|Mean
2771577|NCT00728728|Primary|University of California Performance-based Skills Assessment (UPSA)|The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
2771559|NCT00728910|Primary|The Apolipoprotein A-I Fractional Catabolic Rate (FCR)|After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.|4 weeks, 12 weeks and 22 weeks|Patients who completed any of the three phases for whom the kinetic study data was available for any phase of treatment|||pools/day||95% Confidence Interval|Mean
2771560|NCT00728884|Secondary|Crestal Bone Resorption||four years||2019-12-31|12/2019||||
2771561|NCT00728884|Primary|Osseous Integration||one year|total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|||participants|||Number
2771562|NCT00728845|Secondary|Overall Survival (Phase II)||Treatment start date to date of death|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2771563|NCT00728845|Secondary|Progression-free Survival at 1 Year (Phase II)||Treatment start date to 1 year|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2771564|NCT00728845|Secondary|Time to Progression (Phase II)||Treatment start date and date of progression|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2771565|NCT00728845|Primary|Overall Response (Phase II)||Treatment start date to date of best response|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2771566|NCT00728845|Primary|Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I)||Followed for the duration of the phase 1 treatment, an average of 18 weeks|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2771567|NCT00728819|Secondary|Symptomatic PICC-related Venous Thrombosis|Symptomatic PICC-related venous thrombosis|Procedure through 28 days|Number of participants who had this outcome measure|||Participants|||Count of Participants
2771568|NCT00728819|Secondary|Post-operative Bleeding|Post-operative bleeding|Day 1|Number of participants who received the intervention as assigned|||Participants|||Count of Participants
2771569|NCT00728819|Primary|Evidence of PICC-related Venous Thrombosis|Number participants with vein thrombosis|28 days, PICC removal or hospital discharge||||Participants|||Count of Participants
2771570|NCT00728754|Secondary|Osseous Integration||four years|||||||
2771571|NCT00728754|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).|||millimeters|implants|Standard Error|Mean
2771572|NCT00728728|Secondary|Clinical Global Impressions (CGI) Scale|The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|Missing data for a total of 5 participants for the CGI.|||score||Standard Error|Mean
2771573|NCT00728728|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
2771574|NCT00728728|Secondary|The Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period.||||total score||Standard Error|Mean
2771575|NCT00728728|Primary|Scale for the Assessment of Negative Symptoms(SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
2771576|NCT00728728|Primary|Brief Assessment of Cognition in Schizophrenia (BACS)|The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||Z score||Standard Error|Mean
2771578|NCT00728728|Primary|MATRICS Consensus Cognitive Battery (MCCB)|"The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.~The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance."|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||T score||Standard Error|Mean
2771579|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax|Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||hours||Standard Deviation|Mean
2771580|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax|Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants as 'per protocol'. Form V group lost a particpant during wash-out period due to death in the family.|||ng/mL||Standard Deviation|Mean
2771581|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞|Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.|||ng*hr/mL||Standard Deviation|Mean
2771582|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ|Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||ng*hr/mL||Standard Deviation|Mean
2771583|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½|Mean terminal half-life (t½; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from the half-life analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.|||hours||Standard Deviation|Mean
2771584|NCT00728689|Secondary|Number of Study Participants Who Tolerated a Single Dose of ST-246 Form I vs. Form V as Determined by No Clinically Significant Changes in Safety Parameters|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events For a), b) and c), summary statistics (mean,SD, median, minm, maxm)for values, and changes from baseline(Day 1 pre-dose) to each timepoint, were measured and compared to laboratory normal reference ranges. Values for a)- d) were assigned grades according to DAIDS AE Grading Table. Any Grade of 3 or higher was considered severe and significant."|4 weeks|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||participants|||Number
2771585|NCT00728507|Primary|To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens.|Study was prematurely terminated and data was not collected for this outcome measure.|Weekly or more frequent|||||||
2771586|NCT00728507|Primary|To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy.|LJ culture conversion|Week 8|modified intention to treat population|||percentage of participants|||Number
2771587|NCT00728494|Primary|The Number of Participants Who Relapsed at 6 Months Post-treatment|Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment|Measured at end of treatment and 6 months post-treatment||||Participants|||Number
2771588|NCT00728494|Primary|The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment|Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment|Measured at 6 months post-treatment||||Participants|||Number
2771589|NCT00728494|Secondary|Average Dosage of Rebetol|Rebetol dosage was expressed in milligrams per kilogram of body weight per day.|Up to 48-week treatment duration||||mg/kg/day||Standard Deviation|Mean
2771590|NCT00728494|Secondary|Average Dosage of PegIntron|Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week|Up to 48-week treatment duration||||micrograms/kg/week||Standard Deviation|Mean
2771591|NCT00728494|Secondary|Average Length of Treatment|Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.|Maximum 48-week treatment duration||||Participants|||Number
2771592|NCT00728494|Primary|The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C|Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program|At the end of the 48-week treatment period||||Participants|||Number
2771593|NCT00728481|Primary|Symptomatic Response to Treatment|"Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30).~Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study."|Baseline, 6 months||||Participants|||Number
2771594|NCT00728481|Secondary|Participants With Presence of Erosive Esophagitis at Six Month Endoscopy||Baseline, 6 months||||participants|||Number
2771596|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.|Baseline, 6 months|The analysis population for this item only included subjects with a non-significant histologic response. Subjects were considered to have a histological response to treatment if both sets of 6-month biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.|||Participants|||Number
2771597|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.|Baseline, 6 months|The analysis population includes only subjects with a histologic response. Subjects were considered to have a histological response to treatment if both sets of biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.|||Participants|||Number
2771598|NCT00728481|Primary|Histological Response to Treatment|Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.|Baseline, 6 months||||Participants|||Number
2771599|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.||||||
2771600|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.||||||
2771601|NCT00728468|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.437. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD).|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|All enrolled participants|||months||95% Confidence Interval|Median
2771602|NCT00728468|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Participants with a response (CR or PR) in response analysis set.|||weeks||95% Confidence Interval|Median
2771603|NCT00728468|Secondary|Best Overall Response (BOR)|BOR: investigator assessment by Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD): >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Response anslysis set: all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.|||participants|||Number
2771604|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan on Cycle 2 Day 7|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day 7 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day 7.|8 hours after dosing on Day 7|PK parameter analysis population|||ratio||Standard Deviation|Mean
2771605|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan 3 Days Prior to PF-00299804 Dosing|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day -3 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day -3.|8 hours after dosing on Day -3|PK parameter analysis population: all participants enrolled who were extensive metabolizers (EM), & treated who had at least 1 PK parameter of primary interest in at least 1 treatment period. EMs were defined as participants with a baseline UMR ≤0.3 & were either ultrarapid, extensive, or intermediate metabolizers as predicted by CYP2D6 genotyping.|||ratio||Standard Deviation|Mean
2771606|NCT00728468|Primary|Oral Clearance For Dextromethorphan on Cycle 2 Day 7|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.||||||
2772234|NCT00724451|Secondary|Number of Participants With Treatment Failure by Reason for Failure|Investigators recorded reasons for treatment failure whether or not treatment was completed.|24 to 48 weeks|132 of the 500 treated participants failed treatment per Investigator assessment.|||participants|||Number
2771607|NCT00728468|Primary|Oral Clearance For Dextromethorphan 3 Days Prior to PF-00299804 Dosing|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.||||||
2771608|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan on Cycle 2 Day 7|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Standard Deviation|Mean
2771609|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Standard Deviation|Mean
2771610|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Full Range|Median
2771611|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Full Range|Median
2771612|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng/mL||Standard Deviation|Mean
2771613|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng/mL||Standard Deviation|Mean
2771614|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan on Cycle 2 Day 7|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
2771615|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
2771616|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
2771658|NCT00727857|Secondary|Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration|The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771617|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Pharmacokinetic (PK) analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||nanograms*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2771618|NCT00728416|Secondary|Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2771619|NCT00728416|Primary|Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2771620|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 31 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2771621|NCT00728260|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
2771622|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 0 up to Day 30 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2771623|NCT00728182|Other Pre-specified|Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 with ruptured aneurysms was compared in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30||||No. of participants with mRS 0-2|||Number
2771624|NCT00728182|Other Pre-specified|National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for participants with ruptured aneurysms in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|All subjects who entered the study with a ruptured aneurysm, who received study drug and outcome assessment at Day 30.|||No. of participants with NIHSS 0-1|||Number
2771625|NCT00728182|Other Pre-specified|Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
2771626|NCT00728182|Other Pre-specified|Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
2771627|NCT00728182|Other Pre-specified|Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
2771628|NCT00728182|Other Pre-specified|Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose (pre-specified subgroup analysis)|Enrolment, Days 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
2771629|NCT00728182|Secondary|Modified Rankin Scale (mRS).|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.|Enrolment, Day 30|All patients who received study drug and an outcome assessment at Day 30|||No. of participants with mRS 0-2|||Number
2776332|NCT00697593|Primary|Biochemistry - Potassium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||mmol/L||Standard Deviation|Mean
2771630|NCT00728182|Secondary|National Institutes of Health Stroke Scale (NIHSS).|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.|Enrolment, Day 30|All patients who received study drug and outcome assessment at Day 30.|||No. of participants with NIHSS 0-1|||Number
2771631|NCT00728182|Secondary|Volume of New DWI Lesions (MRI)|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
2771632|NCT00728182|Secondary|Number of New FLAIR Lesions (MRI)|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI scan at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
2771633|NCT00728182|Secondary|Number of New DWI Lesions (MRI)|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.|Enrolment, Day 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
2771634|NCT00728182|Primary|Volume of New FLAIR Lesions(MRI)|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose|Enrolment, Days 2-4|All study patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
2771635|NCT00728130|Secondary|The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.|Pathological detection of carcinoma within each of the dissected nodes reported as node groups.|Post surgical time point||||carcinoma positive nodes||Standard Deviation|Mean
2771636|NCT00728130|Primary|the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.|The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.|Post Surgical Time point||||nodes||Standard Deviation|Mean
2771637|NCT00727961|Primary|Number of Participants With Progression|Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
2771638|NCT00727961|Primary|Number of Participants With Stabilization|All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
2771639|NCT00727961|Primary|Number of Participants With Partial Response|Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
2771640|NCT00727961|Secondary|Mean Survival Time During the Study|Mean time to the occurrence of death|from the beginning of study drug administration up to 18 months||||days||95% Confidence Interval|Mean
2771641|NCT00727961|Secondary|Median Time to Progression|Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|from the beginning of study drug administration up to 4 weeks after chemotherapy completed||||days||95% Confidence Interval|Median
2771642|NCT00727961|Secondary|Mean Time to Positive (Partial) Treatment Response Achievement|"Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.~Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions."|from the beginning of study drug administration up to 4 weeks after chemotherapy completed||||days||Standard Deviation|Mean
2771643|NCT00727961|Primary|Number of Participants With Complete Response|Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||participants|||Number
2771644|NCT00727909|Primary|Percentage of Participants That Selected a Particular Type of Hearing Aid||At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)||||percentage of participants|||Number
2771645|NCT00727857|Secondary|Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration|The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||nmol/L||Standard Error|Least Squares Mean
2771646|NCT00727857|Secondary|Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration|The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771647|NCT00727857|Secondary|Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration|The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771648|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Size|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Error|Least Squares Mean
2771649|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
2771661|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Concentration|The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||nmol/L||Standard Error|Least Squares Mean
2771662|NCT00727857|Secondary|Change From Baseline in Triglycerides|The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
2771663|NCT00727857|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
2771664|NCT00727857|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
2771665|NCT00727857|Secondary|Change From Baseline in Total Cholesterol|The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
2771666|NCT00727857|Secondary|Change From Baseline in Adiponectin|The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mcg/ml||Standard Error|Least Squares Mean
2771667|NCT00727857|Secondary|Median Percent Change From Baseline in High Sensitivity C-reactive Protein|Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100|Baseline and Week 24||||percent||Full Range|Median
2771668|NCT00727857|Secondary|Change From Baseline in Homeostasis Model Assessment - Insulin Resistance|The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||percent of insulin resistance||Standard Error|Least Squares Mean
2771669|NCT00727857|Secondary|Change From Baseline in Fasting Insulin|The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||μIU/mL||Standard Error|Least Squares Mean
2771670|NCT00727857|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
2771671|NCT00727857|Primary|Percent Change From Baseline in Glycosylated Hemoglobin|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2771672|NCT00727844|Primary|Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months.||Sputum smear conversion or max 4 months after the start of Linezolid therapy.||||participants|||Number
2771673|NCT00727740|Primary|Reduction in Pancreatitis Rate|Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.|24 hours||||percentage of participants with PEP|||Number
2771674|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h||0-32h||||ng/Litre||Full Range|Median
2771675|NCT00727714|Secondary|Changes in FeNO Measurements Between Baseline (0h) and 32 h||0-32h||||ppb||Full Range|Median
2771676|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)||Baseline and 6-8h||||ng/Litre||Full Range|Median
2771677|NCT00727714|Secondary|Changes in FeNO Measurements During One Shift (6-8h)||baseline and 6-8h|Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements|||ppb||Full Range|Median
2771678|NCT00727714|Primary|Changes in Lung Function Measurements During One Work Shift (6-8h)|Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity|baseline and 6-8h||||Litres||Standard Deviation|Mean
2771679|NCT00727649|Secondary|Fecal Incontinence Severity Index Score, FISI|The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.|baseline, 4 week and 12 weeks||||units on a scale||Standard Deviation|Mean
2771680|NCT00727649|Primary|Percentage of Bowel Movements With Incontinence|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.|4 weeks||||percentage of incontinent bowel movement||Standard Deviation|Mean
2771681|NCT00727649|Primary|7-day Bowel Diary, Number of Fecal Incontinence Episodes|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.|6 weeks and 12 weeks||||Fecal incontinence episodes||Standard Deviation|Mean
2771682|NCT00727636|Primary|Antibody Titer to HPV 18|Geometric mean titer (95%CI)|Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2771683|NCT00727636|Primary|Antibody Titers to HPV 16|Geometric mean titer (95% CI)|Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2771684|NCT00727636|Primary|Antibody Titer to HPV 11||Month 7|Number of participants who completed all vaccine doses|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2771685|NCT00727636|Primary|Antibody Titer to HPV 6||Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2771686|NCT00727597|Primary|Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events||96 weeks||||participants|||Number
2771687|NCT00727597|Primary|Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)|"Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:~To resolve a Grade 3 or 4 Adverse Event~The subject experienced a virologic failure (as defined in section 3.6.2)~The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue~The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"|96 weeks||||participants|||Number
2771688|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Right Leg|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pounds||Standard Deviation|Mean
2771689|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Left Leg.|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pounds||Standard Deviation|Mean
2771690|NCT00727571|Secondary|Physical Performance: Grip Strength|Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pound-force||Standard Deviation|Mean
2771691|NCT00727571|Secondary|Physical Performance: Time to Rise From Sitting to Standing|Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||seconds||Inter-Quartile Range|Median
2771692|NCT00727571|Secondary|Physical Performance: Duration Walked or Wheeled at Each Visit|The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||minutes||Standard Deviation|Mean
2771693|NCT00727571|Secondary|Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||feet per minute||Standard Deviation|Mean
2771694|NCT00727571|Secondary|Estimated Glomerular Filtration Rate (GFR) for Participants With CKD|Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).|Weeks 1, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||mL/min/1.73 m^2||Standard Deviation|Mean
2771695|NCT00727571|Secondary|Percentage of Participants With Anemia Related Conditions at Baseline|"The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.~Vitamin B12 and folate deficiency based on standard laboratory ranges."|Baseline|Enrolled patients with anemia|||Percentage of participants|||Number
2771696|NCT00727571|Secondary|Number of Participants With Anemia|Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.|Baseline|All enrolled patients with available anemia lab results.|||participants|||Number
2771813|NCT00726752|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Full Range|Median
2771697|NCT00727571|Primary|Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||feet||Inter-Quartile Range|Median
2771698|NCT00727558|Secondary|Inferior Region Corneal Staining|National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=243).|||Units on a scale||Standard Error|Least Squares Mean
2771699|NCT00727558|Secondary|Initial Comfort|"Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent."|at 1 week|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
2771700|NCT00727558|Secondary|End of Day Comfort|Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
2771701|NCT00727558|Secondary|How Comfortable Eyes Feel at the End of the Day|"Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable."|at 1 week wear|Analysis includes participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Error|Least Squares Mean
2771702|NCT00727558|Secondary|Overall Handling|Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
2771703|NCT00727558|Primary|Measured Limbal Hyperemia|Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|at 1 week of wear.|Analysis includes participants who completed the study per protocol and had no missing data (n=243).|||Units on a scale||Standard Error|Least Squares Mean
2771704|NCT00727558|Primary|Overall Comfort|Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear.|Analysis includes participants who completed the protocol and had no missing data (n=240)|||Units on a scale||Standard Error|Least Squares Mean
2771705|NCT00727532|Post-Hoc|Percentage Change of Necrosis From Baseline to Surgery|Changes in MRI will be correlated with findings of necrosis. Amount of necrosis will be measured at baseline and at time of surgery. Percentage change for necrosis will be calculated from baseline and time of surgery.|At time of surgery||||Percentage change||Full Range|Mean
2771706|NCT00727532|Primary|Change in Tumor Size From Baseline to Approximately 29-34 Days After Completion of Neoadjuvant Sorafenib Treatment|Tumors were measured at baseline and approximately 29-34 days after completion of neoadjuvant treatment with sorafenib (just prior to surgery). Tumors were assessed by RECIST response criteria.|Just prior to study week 5||||percent change||Full Range|Median
2771707|NCT00727532|Primary|Percentage Change in Difference in Apparent Diffusion Coefficient Between Baseline and Week 5|Mean Difference in Apparent Diffusion Coefficient [Time Frame: Baseline and Week 5] To assess whether changes in the apparent diffusion coefficient (ADC) during neoadjuvant sorafenib treatment are detectable in locally advanced or metastatic kidney cancer. The ADC value will be calculated at baseline (within 28 days of initiating sorafenib) and Week 5, and the mean difference will be calculated. The percent change between this mean difference is reported. Week 5 ADC value minus baseline ADC value/divided by baseline ADC value was calculated for each participant. Apparent diffusion coefficient (ADC), obtained by measuring diffusion values at magnetic resonance imaging (MRI), is a measure of water mobility. Lower values correspond to tumor and higher values are consistent with cysts. With sorafenib therapy, the amount of free water may increase in a lesion due to necrosis, and as a result the ADC may increase in value.|Baseline and week 5||||Percent change||Full Range|Mean
2771708|NCT00727506|Secondary|Number of Participants With Clinically Relevant Abnormalities for Decreased Cardiac Left Ventricular Function - Phase II|Number of participants with Clinically Relevant Abnormalities for decreased Cardiac left ventricular function.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
2771709|NCT00727506|Secondary|Causes of Death - Phase II|Causes of death during on treatment.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||deaths|||Number
2771710|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase II|Safety of Afatinib assessed based on the number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
2771711|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase II|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
2771712|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AE Leading to Dose Reduction, AEs Leading to Discontinuation of Trial Drug and All SAE- Phase II|Safety was assessed based on number of participants with investigator defined drug−related AEs, AE leading to dose reduction, Adverse events (AEs) leading to discontinuation of trial drug and All Serious Adverse events (SAE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
2771713|NCT00727506|Secondary|Causes of Death - Phase I|Cause of the death reported during on treatment was due to disease progression.|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||deaths|||Number
2771714|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase I|Safety of Afatinib assesed based on Number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
2771715|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase I|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
2771716|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AEs Leading to Discontinuation of Trial Drug, All Serious Adverse Events (AE) and Other Significant AEs - Phase I|Safety was assessed based on number of participants with investigator defined drug−related AEs, AEs leading to discontinuation of trial drug, All Serious Adverse events (AE) and other significant AEs (according to International Conference on Harmonisation (ICH) E3).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
2771717|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP10) Assessed by FISH|Number of participants with Chromosomes (CEP10) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP10) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
2771718|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP7) Assessed by FISH|Number of participants with Chromosomes (CEP7) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP7) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
2771719|NCT00727506|Secondary|Number of Participants With PTEN Assessed by FISH|Number of participants with PTEN assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for PTEN by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
2771720|NCT00727506|Secondary|Number of Participants With EGFR Assessed by FISH|Number of participants with EGFR assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFR by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
2771721|NCT00727506|Secondary|Number of Participants With PAKT Marker Assessed by IHC Test.|Number of participants with PAKT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Serinethreonine kinase (PAKT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
2771722|NCT00727506|Secondary|Number of Participants With PTEN Marker Assessed by IHC Test.|Number of participants with PTEN marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Phosphatase and Tensin Homologue - a tumor suppressor gene/protein (PTEN) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
2771723|NCT00727506|Secondary|Number of Participants With EGFR Marker Assessed by IHC Test.|Number of participants with EGFR marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Epidermal Growth Factor Receptor (EGFR) by immunohistochemistry (IHC) test|Baseline (during screening)|Randomized set|||Participants|||Number
2771724|NCT00727506|Secondary|Number of Participants With MGMT Marker Assessed by IHC Test.|Number of participants with MGMT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for O6-methylguanine-DNA methyltransferase (MGMT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
2771725|NCT00727506|Secondary|Number of Participants With EGFRvIII Assessed by IHC Test.|Number of participants with the epidermal growth factor receptor variant III (EGFRvIII) assessed by IHC test for the evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFRvIII by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
2771726|NCT00727506|Secondary|Phase II - Trough Plasma Concentration of Afatinib|Trough plasma concentration of afatinib after multiple administration of 40 mg afatinib administered as monotherapy or in combination with 75 mg/m² temozolomide|Before (-0.05 h) the drug administration of afatinib on Day 15 of Cycle 2 & 3|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2771727|NCT00727506|Secondary|t1/2 for Temozolomide|terminal half-life (t1/2) of temozolomide in presence and absence of afatinib|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||hours||Geometric Coefficient of Variation|Geometric Mean
2771728|NCT00727506|Secondary|Tmax for Temozolomide|time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||h||Full Range|Median
2771729|NCT00727506|Secondary|Cmax for Temozolomide|maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2771730|NCT00727506|Secondary|AUC (0-8) for Temozolomide|Area under the plasma concentration-time curve over the time interval from zero to 08h (AUC (0-8)) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2771731|NCT00727506|Secondary|Tmax,ss for Afatinib|time from dosing to the maximum plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set|||hour||Full Range|Median
2771732|NCT00727506|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide.|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set|||ng/mL||Standard Deviation|Geometric Mean
2771733|NCT00727506|Secondary|AUCτ,ss for Afatinib|Area under the plasma concentration-time curve of afatinib after multiple administration (AUCτ,ss) of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide (TMZ).|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS Set and the patients who had enough PK samples for calculation of AUC. Pharmacokinetic set (PKS) : All patients who provided at least one blood sample were included in the Pharmacokinetic (PK) analysis.|||ng·h/mL||Standard Deviation|Geometric Mean
2771734|NCT00727506|Secondary|Progression-free Survival (PFS)- Phase II Part|Progression-free survival was defined as the duration between randomization and the date of the first of the two following events: progression or death.|from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.|Randomized set|||Months||Full Range|Median
2771735|NCT00727506|Secondary|Objective Tumor Response in Phase II|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review. Only data collected until cut-off date July 15, 2016 were considered.|From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days|RS|||participants|||Number
2771736|NCT00727506|Secondary|Objective Tumor Response in Phase I|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review.|From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.|Patients treated in Phase I part|||participants|||Number
2771737|NCT00727506|Primary|Progression-free Survival (PFS-6) at Six Months - Phase II|"PFS-6 is defined as probability of patients surviving to six months after randomization without progression. Disease progression was evaluated by an independent review committee and by the investigators, independently. The evaluation by the independent review committee was used for the primary outcome measure. The measurement Number the estimated PFS-6 value from the Kaplan-Meier curve of PFS."|At six months after randomization|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment in the Phase II part of the trial.|||probablity of survival||95% Confidence Interval|Number
2771738|NCT00727506|Primary|Number of Participants With DLT- Phase I|Number of Participants With Dose Limiting Toxicities (DLT) - Phase I Part|From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days||||participants|||Number
2771739|NCT00727441|Secondary|Disease Free Survival|Disease free survival is defined as the time interval from the date of randomization to the date of radiographic evidence of disease recurrence. Estimation based on the Kaplan-Meier curve.|10 years and 7 months||||months||95% Confidence Interval|Median
2771740|NCT00727441|Secondary|Overall Survival|OS will be measured from date of randomization until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.|10 years and 7 months||||months||95% Confidence Interval|Median
2771741|NCT00727441|Primary|Change in the Number and Function of Peripheral Mesothelin-specific CD8+ T Cells and CD4+, FoxP3+, and GITR+ Tregs|Change in the number and function of peripheral mesothelin-specific CD8+ T cells and CD4+, FoxP3+, and GITR+ Tregs after each GVAX pancreatic cancer vaccination when administered alone or in combination with a single dose or metronomic doses of cyclophosphamide.|up to 8 years|Data was not collected for this outcome measure.||||||
2771742|NCT00727441|Primary|Amount of T-regulatory Cells (Tregs) and CD4+ and CD8+ Effector T Cells, After Neoadjuvant GVAX Pancreatic Cancer Vaccination.||up to 8 years|Data was not collected for this outcome measure.||||||
2771743|NCT00727441|Primary|Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0||7 years||||Participants|||Count of Participants
2771744|NCT00727415|Secondary|Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.).||After 6 months from study entry (end of treatment).||||percentage of participants|||Number
2771745|NCT00727415|Secondary|Number of Patients With Severe Infections|Severe infection requiring more than 2 weeks of antibiotic therapy.|At 24 months from study entry (end of follow-up)||||participants with severe infecitons|||Number
2771746|NCT00727415|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Data from all subjects who receive any study drug will be included in the safety analyses.|At 24 months from study entry (end of follow-up)|Fourteen (35%) patients have died.|||Participants who died during the study|||Number
2771747|NCT00727415|Secondary|Number of Patients Reaching Disease-free Survival (DSF) Overall|Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular.|After 6 months from study entry (end of treatment)||||percentage of participants on DFS||95% Confidence Interval|Number
2771748|NCT00727415|Primary|Overall Complete Response (CR) Rate (Phase II)|Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular.|After 6 months from study entry (end of treatment).|7 patients coming from the phase I + 33 patients enrolled from the phase II. The whole population of phase II part of the trial is composed of a total of 40 patients.|||percentage of patients in CR|||Number
2771749|NCT00727415|Primary|Maximum Tolerated Dose of Lenalidomide (Phase I)|Maximum tolerated dose of lenalidomide given in combination with fludarabine.|The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.||||number of patients without DLT|||Number
2771750|NCT00727402|Primary|Cumulative Incidence of Corneal Inflammatory Events|Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.|annual||||annual incidence per 100 subjects|Participants|95% Confidence Interval|Mean
2771751|NCT00727337|Secondary|Hearing Handicap Inventory for the Elderly (HHI) Change|The HHI is a 25-item questionnaire that assesses the social and emotional consequences of hearing loss. The HHI for the elderly is for individuals age 65 years and older (Ventry & Weinstein 1982); the HHI for adults is for individuals aged 64 years and younger (Newman et al. 1990). The versions differ in the wording of three questions. The participants were asked to complete the appropriate HHI for aided listening to reflect their residual hearing handicap. HHI items are answered on a scale of Yes (4 points), Sometimes (2 points) and No (0 points), with higher scores indicating greater reported hearing handicap. Total HHI scores, which can range from 0 to 100, were used for all analyses.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||units on a scale||Standard Deviation|Mean
2771752|NCT00727337|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB) Change|The Abbreviated Profile of Hearing Aid Performance (APHAP; Cox & Alexander 1995) was used to assess activity limitations and the Hearing Handicap Inventory for the Elderly or Adults (HHI; Ventry & Weinstein 1982; Newman et al. 1990) was used to assess participation restrictions. The APHAP is a 24-item questionnaire that documents hearing difficulties in specified listening situations. The items are answered on a 7-point scale from 'Always' (or 99%) to 'Never' (or 1%) with higher scores indicating greater reported hearing difficulty. The APHAP global score that ranges from 1 to 99 was used for all analyses.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||units on a scale||Standard Deviation|Mean
2771753|NCT00727337|Primary|Words-in-Noise Test (WIN) Change|Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||dB SNR||Standard Deviation|Mean
2771754|NCT00727311|Primary|Number of HCV-RNA Negative Participants at Follow-up|HCV-RNA was measured by PCR.|24 weeks post-treatment (Weeks 48 or 72, depending on genotype)|Number of participants with results at the 6 month follow-up examination|||Participants|||Number
2771755|NCT00727311|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT|24 weeks post-treatment (Week 48 or 72, depending on genotype)|Number of evaluable participants with follow-up information|||Participants|||Number
2771756|NCT00727311|Primary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA~negativity from baseline to Week 12"|Treatment Week 12|Number of evaluable participants at 12 weeks of treatment|||Participants|||Number
2771757|NCT00727311|Primary|Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)|HCV-RNA level was measured by polymerase chain reaction (PCR).|24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6|Number of evaluable participants at EoT|||Participants|||Number
2771758|NCT00727298|Secondary|Clinicians' Impression of Therapeutic Efficacy|Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.|Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.|||Percentage of Participants|||Number
2771759|NCT00727298|Secondary|Clinicians' Impression of Disease Severity From Baseline to Week 102|Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.|Baseline, Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.|||Percentage of Participants|||Number
2771760|NCT00727298|Primary|Number of Participants Experiencing at Least One Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.|Baseline to Month 24|The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.|||Participants|||Number
2776333|NCT00697593|Primary|Biochemistry - Sodium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||mmol/L||Standard Deviation|Mean
2771761|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
2771762|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
2771763|NCT00727272|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng/mL||Standard Deviation|Mean
2771764|NCT00727259|Primary|Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months|Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).|The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.|Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.|||satisfaction rating from 0-7||Standard Deviation|Mean
2771765|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls|A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. Higher T-scores indicate higher levels of cognitive functioning. Due to the small number of subjects in this study, this second analysis was completed using the same number of subjects in the TBI and control groups, but without matching so that a slightly larger number of subject's data could be utilized. Although analyses were run, due to the very small number of participants in this study, results should be considered with caution.|6 weeks|cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. See note above related to the limited number of subjects in each group.|||T-score||95% Confidence Interval|Mean
2771766|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment Group.|.A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. A higher T-score indicates a higher level of cognitive function. Due to matching criteria of age range, gender and education level, as well as the small number of subjects with TBI who complete the study (n = 5), matched groups required a reduction to 2 subjects per group for analysis as planned per protocol. Due to the small number of subjects in this study overall, although analyses were run, results should be considered with caution.|6 weeks|A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of subjects with TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. Matching criteria and small n for TBI group reduced group sizes.|||T-score||95% Confidence Interval|Mean
2771767|NCT00727220|Primary|Change in HgBA1c||Baseline and 6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2771768|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Ptosis)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.|||units on a scale||Standard Deviation|Mean
2771769|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Double Vision)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.|||units on a scale||Standard Deviation|Mean
2775837|NCT00701363|Secondary|Serum Growth Hormone (GH) Levels||At Baseline, week 24 and week 48|"ITT population. n = Number of subjects at the visit.~Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2."|||ng/mL||Standard Deviation|Mean
2771770|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Negative Inspiratory Force. NIF is a measurement of respiratory muscle strength and ventilator reserve. NIF is represented by centimeters of water pressure (cmH2O). A normal NIF measurement is negative 60 cmH2O, or as 100% predicted value.|16 weeks|Comparison of NIF at the Last Visit Between Eculizumab and Placebo Cohorts.|||percentage of predicted||Standard Deviation|Mean
2771771|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Forced Vital Capacity|16 weeks|Comparison of FVC at the Last Visit Between Eculizumab and Placebo Cohorts.|||percentage of predicted||Standard Deviation|Mean
2771772|NCT00727194|Secondary|Change From Baseline in the QoL Instrument, SF-36.|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (physical functioning, role-physical, bodily pain, general health, mental health, role-emotional, social functioning and vitality) as well as psychometrically-based physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. The lower the score the more disability; the higher the score the less disability. Norm-based scoring involving a linear T-score transformation method was used so that scores for each of the health domain scales and component summary measures have a mean of 50 and a standard deviation of 10 based on the 1998 US general population. Thus, scores above and below 50 are above and below the average, respectively, in the 1998 US general.|16 weeks|Comparison of SF-36 at the Last Visit Between Eculizumab and Placebo Cohorts.|||units on a scale||Standard Deviation|Mean
2771773|NCT00727194|Secondary|Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)|The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living (ADL) in MG patients. The 8 items of the MG-ADL were derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 - 24. MG-ADL was to be performed at every study visit. The recall period for MG-ADL was since the preceding study visit (1 or 2 weeks).|16 weeks|Comparison of MG Activities of Daily Living (Total score) at the Last Visit Between Eculizumab and Placebo Cohorts.|||units on a scale||Standard Deviation|Mean
2771774|NCT00727194|Secondary|Change From Baseline in the MGFA Post-Intervention Status (PIS)|The MGFA PIS is designed to assess the clinical state of MG patients at any time after treatment of MG is initiated. Change in status categories of Improved, Unchanged, Worse, Exacerbation, and Died of MG was to be assessed and recorded at every visit from Visits 3 to 24 (Weeks 1 to 16). Minimal manifestations were to be assessed at these visits.|16 weeks||||participants|||Number
2771775|NCT00727194|Secondary|Mean Change From Baseline in QMG Total Score|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The Myasthenia Gravis Foundation of America task force has recommended that the QMG score be used in prospective studies of therapy for MG. The QMG scoring system consists of 13 items. Each item is graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0-39.|16 weeks||||units on a scale||Standard Deviation|Mean
2771776|NCT00727194|Primary|Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG.|16 weeks||||percentage of patients|||Number
2771777|NCT00727090|Secondary|Glasgow Coma Scale|Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)|48 hours|||||||
2771778|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 48 Hours||48 hours||||mMol/L||Standard Deviation|Mean
2771779|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 36 Hours||36 hours||||mMol/L||Standard Deviation|Mean
2771780|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 24 Hours||24 hours||||mMol/L||Standard Deviation|Mean
2771781|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 18 Hours||18 hours||||mMol/L||Standard Deviation|Mean
2771782|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 12 Hours||12 hours||||mMol/L||Standard Deviation|Mean
2771783|NCT00727090|Secondary|NIH Stroke Scale|Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).|48 hours|||||||
2771784|NCT00727090|Primary|Change in Serum Sodium From Baseline to 6 Hours||48 hours|Intention to treat|||mMol/L||Standard Deviation|Mean
2771785|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
2771786|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status|Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
2771814|NCT00726752|Secondary|Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 12 hours in this study.|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng*h/mL||Standard Deviation|Mean
2771787|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
2771788|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
2771789|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
2771790|NCT00727064|Primary|Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status|Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
2771791|NCT00727025|Primary|Time to Perform Wound Closure|Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture|intraoperatively|those who completed application of devices intraoperatively|||minutes||Standard Deviation|Mean
2771792|NCT00727025|Secondary|Patient Postoperative Incisional Comfort|Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable|10 days||||units on a scale||Standard Deviation|Mean
2771793|NCT00727025|Primary|Scar Quality at 6 Months Postoperative|Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.|6 months||||units on a scale||Standard Deviation|Mean
2771794|NCT00726999|Secondary|Number of Ondansetron Doses Administered for Nausea|The number of doses of Ondansetron given for nausea to participants in both groups.|First 10 days after surgery||||doses of medication administered||Inter-Quartile Range|Median
2771795|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 2||||mg/kg/h||Standard Deviation|Mean
2771796|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 1||||mg/kg/h||Standard Deviation|Mean
2771797|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)|Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.|PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)||||mg/kg/h||Standard Deviation|Mean
2771798|NCT00726986|Secondary|Safety|Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.|Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||participants|||Number
2771799|NCT00726986|Secondary|Response Rate|"The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|reevaluated for response every 8 weeks|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||participants|||Number
2771800|NCT00726986|Secondary|Median Overall Survival|Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||months||95% Confidence Interval|Median
2771801|NCT00726986|Primary|Progression-free Survival(PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||months||95% Confidence Interval|Median
2771802|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
2771847|NCT00726622|Secondary|Disease-free Survival||Up to 2 years post surgery|||||||
2776334|NCT00697593|Primary|Hematology - Platelet Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values|||x10^9/L||Standard Deviation|Mean
2771803|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
2771804|NCT00726895|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng/mL||Standard Deviation|Mean
2771805|NCT00726882|Secondary|Number of Participants With Serious Adverse Events Related to Study Procedures|Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|48 weeks||||participants|||Number
2771806|NCT00726882|Primary|Persistence of Resistance-Associated Variants and Phenotypic Resistance|Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.|Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks|Resistance analyses included all participants who received ABT-333 in the previous study who had sufficient HCV RNA recovered from samples collected during this study for genotypic and phenotypic analysis to proceed. m, n = the number of evaluable participants for the analysis specified for M10-380 and M10-351, respectively.|||participants|||Number
2771807|NCT00726830|Secondary|Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items||28 days|||||||
2771808|NCT00726830|Primary|Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)|MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The 'primary success' is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).|28 days|No Analysis accomplished as there is not sufficient participant data to meet the study end points.||||||
2771809|NCT00726752|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.|Up to 470 days of treatment plus 28-days follow-up|Safety analysis set was defined as all enrolled participants who received the study drug at least once in this study (same as the full analysis set:FAS).|||participants|||Number
2771810|NCT00726752|Secondary|Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 470 days|Anti-tumor response analysis set was defined as all participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug.|||participants|||Number
2771811|NCT00726752|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF|Prior to the initial dose (baseline) and Day 1 of Cycle 2|Pharmacodynamic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacodynamic blood sampling for at least 1 day.|||percent||Full Range|Median
2771812|NCT00726752|Secondary|Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ratio||Standard Deviation|Mean
2771862|NCT00726453|Secondary|Target Vessel Failure (TVF)|Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).|12 months||||percentage of participants|||Number
2771815|NCT00726752|Secondary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax)|Cmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng/mL||Standard Deviation|Mean
2771816|NCT00726752|Primary|Single Dose: Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Standard Deviation|Mean
2771817|NCT00726752|Primary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Full Range|Median
2771818|NCT00726752|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng*hr/mL||Standard Deviation|Mean
2771819|NCT00726752|Primary|Single Dose: Maximum Observed Plasma Concentration (Cmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng/mL||Standard Deviation|Mean
2771820|NCT00726739|Secondary|Immune Response|Immune responses is be assessed by Delayed Type Hypersensitive (DTH) responses to LMI, IFN-γ production by CD8 T cells using the ELISPOT assay, and CD8 T cell binding to HLA-A2 multimers complexed with melanoma-derived peptides (pentamer analysis). DTH reactions are determined at 48 hours by measuring the largest diameter and right angle diameter of the area of induration and calculating the mean. DTH responses are recorded as present or absent but cannot be used as a quantitative measure of immune activation.|48 hours After Study Medication||||participants|||Number
2771821|NCT00726739|Secondary|Overall Survival at 1 Year|One year survival (alive at 1 year from randomization) rate of each treatment group.|1 Year||||Percentage of patients|||Number
2771822|NCT00726739|Secondary|Overall Survival at 2 Years|Two year survival (alive at 2 years from randomization) rate of each treatment group.|2 Years||||percentage of patients|||Number
2771823|NCT00726739|Secondary|Clinical Response of Lesion(s)|Beginning at 2 months Through End of Treatment: To determine clinical response of each treatment group - Best Clinical response will be determined using Solid Tumor Response Criteria (RECIST). Complete Response (CR) = complete disappearance of all target lesions. Partial Response (PR) = At least a 30% decrease in sum of longest diameters of target lesions. Progressive Disease (PD) = At least a 20% increase in sum of longest diameters of target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR or PD.|Month 2 through Month 12|All patients who received at least one dose of study treatment are included. One patient who was originally screened did not receive treatment due to brain metastasis.|||participants|||Number
2771824|NCT00726739|Primary|Median Time of Progression-free Survival|Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.|From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.|All patients who received at least one dose of study treatment are included. One patient who was originally screened and randomized did not receive treatment due to brain metastasis. This patient was included in PFS analysis based on the intent-to-treat principle, but was excluded from the evaluation of adverse events.|||Months||Full Range|Median
2771825|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including Potential Antioxidant (PAO)|Analyte levels were taken at 0 (Baseline) and 24 weeks||||µmol/L||Standard Deviation|Mean
2771826|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including hs-CRP|Analyte levels were taken at 0 (Baseline) and 24 weeks||||mg/L||Standard Deviation|Mean
2771827|NCT00726713|Secondary|Change From Baseline in Total Homocysteine at Week 16 and 24|To determine if Metanx® (compared to placebo) affects change in subjects total homocysteine levels|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks||||µmol/L||Standard Deviation|Mean
2771828|NCT00726713|Secondary|(Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24|The Hospital Anxiety and Depression Scale (HADS) consists of a 14-item questionnaire that provides a measurement of depression. Each item is rated on a 4-point scale, giving a maximum scores of 21 for the most severe depression. Depression was evaluated using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, and 24-week evaluation visits|HADS Scores scores were taken at 0 (Baseline) and 24 weeks||||units on a scale (0-21)||Standard Deviation|Mean
2771829|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory marker levels, including IL-6 and TNF-α|Analyte levels were taken at 0 (Baseline) and 24 weeks||||pg/mL||Standard Deviation|Mean
2771830|NCT00726713|Secondary|Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24|"To determine if Metanx® (compared to placebo) affects a subject's lower extremity pain level using a 10-point Visual Analog Scale at Baseline and 24-week evaluation visits.~The Visual Analog Scale (VAS) measures a patients sensation of pain. A 10-cm visual analog scale is used. A measurement on the 10 cm analog scale is used to quantify the level of pain indicated with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable."|VAS scores were taken at 0 (Baseline) and 24 weeks||||units on a scale (0-10)||Standard Deviation|Mean
2771831|NCT00726713|Secondary|Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24|"To determine if Metanx® (compared to placebo) affects a subject's quality of life as determined by the SF-36 questionnaire~The Short Form- 36 Mental Component Summary (SF-36 MCS) and SF-36 Physical Component Summary (SF-36 PCS) both measure health related quality of life, the MCS quantifying mental health and the PCS quantifying physical function. They are both scored on 100 point scales with 0 representing the worst possible outcome and 100 representing the most optimal possible scoring"|SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks||||units on a scale (0-100)||Standard Deviation|Mean
2771832|NCT00726713|Secondary|Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24|To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks||||nmol/L||Standard Deviation|Mean
2771833|NCT00726713|Secondary|Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24|"This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS)~The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10."|NDS scores were taken at 0 (Baseline), 16, and 24 weeks||||units on a scale (0-10)||Standard Deviation|Mean
2771834|NCT00726713|Secondary|Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)|"This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)~The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks."|NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks||||units on a scale (0-6)||Standard Deviation|Mean
2771835|NCT00726713|Primary|Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks|Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.|VPT was measured a 0 (baseline), and 24 weeks||||volts||Standard Deviation|Mean
2771836|NCT00726661|Secondary|Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy|All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
2771837|NCT00726661|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
2771838|NCT00726661|Secondary|Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation|Participants were assessed quarterly for progressive events and treatment status.|Approximately 4.5 years|All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point.|||participants|||Number
2771839|NCT00726661|Secondary|Number of Participants With Tumor Response|The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
2771840|NCT00726661|Secondary|Overall Survival|Overall survival was defined as the time from enrolment to death of any cause.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
2771841|NCT00726661|Primary|Progression Free Survival|Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
2771842|NCT00726622|Secondary|Bowel and Stoma Function||Up to 5 years post surgery|||||||
2771843|NCT00726622|Secondary|Bowel Function||Up to 5 years post surgery|||||||
2771844|NCT00726622|Secondary|Quality of Life and Sexual Function||Up to 5 years post surgery|||||||
2771845|NCT00726622|Secondary|Overall Survival||Up to 5 years post surgery|||||||
2771846|NCT00726622|Secondary|Local Pelvic Recurrence Rates||Up to 2 years post surgery|||||||
2771848|NCT00726622|Secondary|Operative Times|Open to close operative time.|During surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||minutes||Standard Deviation|Mean
2771849|NCT00726622|Secondary|Use of Pain Medication|The number of days patients received parenteral narcotics post-surgery were counted.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||days||Standard Deviation|Mean
2771850|NCT00726622|Secondary|Length of Stay|The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||days||Standard Deviation|Mean
2771851|NCT00726622|Secondary|Circumferential Margin > 1 mm|The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2771852|NCT00726622|Secondary|Negative Distal Resected Margin|The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2771853|NCT00726622|Secondary|Completeness of Total Mesorectal Excision (Complete or Nearly Complete)|"Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.~The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI."|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2771854|NCT00726622|Primary|Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.|"The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.~Primary endpoint parameters:~Circumferential margin > 1 mm~Negative distal margin~Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.~All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior."|At time of Surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2771855|NCT00726609|Primary|Number of Participants Reporting Adverse Drug Reactions.|"The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:~Mild: The abnormality, symptom or event is noticed but well tolerated.~Moderate: Symptoms impair normal activities and may require intervention.~Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required."|Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.||||Participants|||Number
2771856|NCT00726557|Primary|Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week|Tolerability of the treatment was measured by number of participants with complete treatment.|Assessed at the end of treatment|All enrolled participants|||participants|||Number
2771857|NCT00726557|Primary|Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions|Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).|End of Follow-up (Week 48 or Week 72, depending on genotype)|Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)|||Participants|||Number
2771858|NCT00726453|Secondary|Stent Thrombosis (ST)|Stent Thrombosis (ST) (as determined by historic and ARC definitions).|12 months||||percentage of participants|||Number
2771859|NCT00726453|Secondary|Target Vessel MI|Target Vessel MI (as determined by extended historical and ARC definitions).|12 months||||percentage of eligible participants|||Number
2771860|NCT00726453|Secondary|Death||12 months||||percentage of participants|||Number
2771861|NCT00726453|Secondary|Major Adverse Cardiac Event (MACE)|Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).|12 months||||percentage of participants|||Number
2771863|NCT00726453|Primary|Target Lesion Failure (TLF)|Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.|12 Months||||percentage of participants|||Number
2771864|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng-hr/mL||Standard Deviation|Mean
2771865|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng-hr/mL||Standard Deviation|Mean
2771866|NCT00726414|Primary|Maximum Plasma Concentration (Cmax) for Quinine Sulfate|The maximum or peak concentration that Quinine Sulfate reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng/mL||Standard Deviation|Mean
2771867|NCT00726375|Secondary|The Number of Patients in Complete Remission (CR) at Four Weeks.|"Estimate the proportion of patients in complete remission (CR) at four weeks who remain alive and never require additional therapy four weeks after the last dose of etanercept.~Complete remission is defined as the resolution of all manifestations of GVHD (Graft Versus Host Disease) within the first four weeks of treatment. All organs must have a Grade 0."|28 days||||patients|||Number
2771868|NCT00726375|Primary|The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment|We hypothesized that treatment of grade 1 acute GVHD (Graft Versus Host Disease) with etanercept would reduce the proportion of patients who progressed to grade 2 to 4 acute GVHD within 4 weeks of diagnosis from 58%, historically observed at our institution, to 38%.|28 days||||percentage of patients|||Number
2771869|NCT00726323|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 4 years|Safety population|||Participants|||Number
2771870|NCT00726323|Secondary|Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)|CTCAE gradation The worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for hemoglobin, leukocytes, platelets, percentage of lymphocytes, and percentage of neutrophils.|Up to 4 years|Safety population|||Participants|||Number
2771871|NCT00726323|Secondary|Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period|The worst case overall common terminology criteria for adverse events (CTCAE) grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases (ALT), aspartate aminotransferases (AST), Albumin, alkaline phosphatase (ALP), calcium, sodium, potassium, glucose, amylase, carbon dioxide, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. High (H) levels and low (L) levels were measured.|Up to 4 years|Safety population|||Participants|||Number
2771872|NCT00726323|Secondary|Overall Survival|Overall survival, which is defined as the time between the date of first dose of study drug and the date of death (due to any cause). For participants who were alive at the time of data cutoff, duration of overall survival was right censored at the date of last contact. Duration of overall survival = date of death/censoring - date of first dose +1. Percentiles and confidence intervals are calculated using Kaplan-Meier methods.|Up to 4 years|Safety population|||Months||95% Confidence Interval|Median
2771873|NCT00726323|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as the time between the date of first dose of study drug and the date of the first occurrence of one of the tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to disease progression, or disease progression as documented on the follow-up participants status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of stable disease was right censored at the date of the last available tumor measurement.|Up to 4 years|Safety population. All participants with Best overall response, not progressive disease were considered.|||Months||95% Confidence Interval|Median
2771885|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 36 (Cycle 10, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
2771874|NCT00726323|Secondary|Duration of Response (DOR)|Duration of response is defined as the time between the date of first response (later confirmed CR or confirmed PR) and the date of the first occurrence of one of the events as tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to any cause, disease progression as documented on the follow-up or participant status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of response was censored at the date of the last available tumor measurement.|Up to 4 years|Safety Population- All Objective Responders (those who did not reach an event by the time of data cut-off as defined in protocol)|||Months||95% Confidence Interval|Median
2771875|NCT00726323|Secondary|Time to Response (TTR) Over Period|Time to response is the time between the date of first dose of study drug and the date of first response (for participants who had overall responses that were later confirmed as CR/PR). For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the time to response was censored at the date of the last visit. The median time to response was not estimable in either of the dosing cohorts or in the overall safety population using the Kaplan-Meier method.|Up to 4 years|Safety population|||Months||95% Confidence Interval|Median
2771876|NCT00726323|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the time between the date of first dose of study drug and the date of the first occurrence of either tumor progression per RECIST or clinical assessment of progression as assessed by Investigator or Death due to any cause, whichever occurs the first. For participants who did not reach an event (disease progression or death) at the time of data cutoff, PFS was censored at the date of the last available tumor measurement. For participants who did not have any post-baseline tumor assessments, PFS was right censored at Day 1. For any participants who received subsequent anticancer therapy, PFS was right censored at the date of last adequate tumor assessment on or prior to the date of anticancer initiation. For any participants, who died or progressed after an extended follow-up, PFS was censored at the date of last adequate assessment prior to the extended loss to follow-up.|At the end of forth year|Safety population|||Months||95% Confidence Interval|Median
2771877|NCT00726323|Secondary|Disease Stabilization Rate Over Period|The percentage of participants for whom the best overall response was a confirmed PR, confirmed CR, or stable disease. Exact confidence intervals were obtained using the Clopper-Pearson method. Exact confidence intervals were obtained using the Clopper-Pearson method.|Up to 4 years|Safety population|||Percentage of participants||95% Confidence Interval|Number
2771878|NCT00726323|Primary|Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.|At the end of forth year|The Safety population included all participants who passed the screening criteria, were enrolled in the study and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2771879|NCT00726232|Secondary|Change From Baseline to Week 4 in Health-related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 4 (Cycle 2, Day 1)|Intent to treat population. The intent-to-treat (ITT) population included all subjects who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2771880|NCT00726232|Secondary|Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness."|Baseline and Week 4 (Cycle 2, Day 1)|Essential Thrombocythemia intent to treat population who had symptom scores > 0 at baseline and for whom data was available.|||score on a scale||Standard Deviation|Mean
2771881|NCT00726232|Secondary|Change From Baseline to Week 4 in Polycythemia Vera Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats."|Baseline and Week 4 (Cycle 2, Day 1)|Polycythemia Vera intent to treat population who had symptom scores > 0 at baseline for whom data was available.|||scores on a scale||Standard Deviation|Mean
2771882|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 36 weeks (Cycle 10, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
2771883|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 24 weeks (Cycle 7, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
2771884|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 4 weeks (Cycle 2, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
2776335|NCT00697593|Primary|Hematology - Lymphocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
2771886|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 24 (Cycle 7, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
2771887|NCT00726232|Primary|Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~Complete Clinical Response:~Platelet count < 400 x 10^9/L~White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal~Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges~Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias)~Absence of palpable splenomegaly~Partial Clinical Response:~Platelet count < 400 x 10^9/L~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.|Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1.|||percentage of participants|||Number
2771888|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 12 (Cycle 4, Day 1)|Polycythemia Vera intent to treat population for whom data was available.|||percentage of participants|||Number
2771889|NCT00726232|Primary|Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~CR:~Hematocrit < 45% in men and < 42% in women~No phlebotomy for 1 month~No palpable splenomegaly~White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L~No sustained leucopenia or thrombocytopenia (>2 weeks)~No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss)~PR:~Hematocrit < 45% in men and < 42% in women~50% reduction in phlebotomy requirements from 6 months before treatment started~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3|Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug.|||percentage of participants|||Number
2771890|NCT00726180|Primary|Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer.||90 days|Only 1 patient was enrolled to this study, so no data was obtained.||||||
2771891|NCT00726063|Primary|Integration Success of the Implant||1 year|Number of implants surviving (lack of mobility) at the end of the study (time of analysis)|||implants|Implants||Number
2771892|NCT00726037|Secondary|Optimal Time for Future Dendritic Cell Vaccine Administration|The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration|33 Days|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption||||||
2771893|NCT00726037|Primary|T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer|The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.|days 8, 12 ,19,26 and 33 post administration|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption||||||
2771894|NCT00725985|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Number of participants with AEs includes number of participants with both serious adverse events (SAEs) and non-SAEs.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo) and had at least one safety assessment during the ITP.|||Participants|||Number
2771895|NCT00725985|Secondary|Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, new or enlarging T2 lesions, and new or persisting T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Lesions||Standard Deviation|Mean
2771896|NCT00725985|Secondary|Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS|The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions. Kaplan-Meier estimates were provided for the cum. % of participants with McDonald MS over time.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Cum. % of participants with McDonald MS|||Number
2771969|NCT00725543|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Standard Deviation|Mean
2771897|NCT00725985|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS|Clinically definite multiple sclerosis (CDMS) according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (>=) 1 point if baseline EDSS was between >= 1.0 and less than or equal to (=<) 4.5; or >= 1.5 points if baseline EDSS was 0, or >= 0.5 if baseline EDSS >= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.|Baseline up to Week 96|The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Cum. % of participants with CDMS|||Number
2771898|NCT00725959|Secondary|Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions||two months|||||||
2771899|NCT00725959|Primary|Proportion of Condom Usage|number of times condom used divided by number of times person had sex in past 60 days|two months||||proportion of condom use||95% Confidence Interval|Mean
2771900|NCT00725920|Primary|Clinician Administered Posttraumatic Stress Disorder Scale|"The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.~CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).~CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity."|12 week||||Total CAPS score||Standard Deviation|Mean
2771901|NCT00725842|Secondary|Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.|72 weeks post EOT|77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.|||participants|||Number
2771902|NCT00725842|Secondary|Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response|Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.|Baseline and 24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.||||||
2771903|NCT00725842|Secondary|Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment|Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.|24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.||||||
2771904|NCT00725842|Primary|Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.|24 weeks post end of treatment (EOT)|Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.|||participants|||Number
2771905|NCT00725764|Secondary|Apparent Volume of Distribution|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent volume of distribution was not derived as pharmacokinetic analysis was not completed. Data was not collected for PK analysis.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
2771906|NCT00725764|Secondary|Apparent Oral Clearance|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent oral clearance was not derived as pharmacokinetic analysis was not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
2771907|NCT00725764|Secondary|Elimination Half-life (t1/2) of Foretinib in Participants With SCCHN|t1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
2771908|NCT00725764|Secondary|Area Under the Concentration-time Curve (AUC) of Foretinib in Participants With SCCHN|AUC was defined as area under the plasma concentration vs. time curve. Blood samples were planned to be collected on time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
2772188|NCT00724815|Primary|Pain Free at Two Hours|Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
2771909|NCT00725764|Secondary|Time to Maximum Plasma Concentration (Tmax) of Foretinib in Participants With SCCHN|"tmax was defined as the time to the maximum or peak concentration of a drug observed after multiple administration. Blood samples were planned to be obtained during the time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint."|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
2771910|NCT00725764|Secondary|Maximum Plasma Concentration (Cmax) of Foretinib in Participants With Squamous Cell Carcinoma of the Head and Neck (SCCHN)|Plasma samples for pharmacokinetic analysis were planned to be drawn at time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing) of each treatment cycle, however these analyses were not completed. Cmax was defined as maximal measured plasma concentration over the time span specified. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
2771911|NCT00725764|Secondary|Percentage Participants With Disease Stabilization Rate|Disease stabilization rate was defined as the proportion of participants for whom the best overall response was a PR, CR, or stable disease. percentage participants with disease stabilization rate were presented.|Approximately up to 1 year|Safety Population|||percentage of participants||95% Confidence Interval|Number
2771912|NCT00725764|Secondary|Duration of Stable Disease|Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Duration of stable disease was defined as the time between the date of first dose of study drug and the first occurrence of 1 of the events: Tumor progression per RECIST as assessed by the investigator, Termination of study drug because of disease progression, Death due to disease progression, Disease progression as documented on the participant follow-up status form, Initiation of subsequent anticancer therapy.|Approximately up to 1 year|Safety Population. Analysis set included only participants whose best overall response was not disease progression.|||Months||Full Range|Median
2771913|NCT00725764|Secondary|Duration of Overall Survival|Overall survival was defined as the duration from the date of the first dose to the date of death. The start of a confounding anticancer therapy was treated as a censoring event. Every effort made to follow participant's until death. Time to death was censored at the date of the latest participant contact or at the analysis cutoff date, if earlier. Kaplan-Meier method was used to estimate the overall survival distribution.|Approximately up to 1 year|Safety Population.|||Months||Full Range|Median
2771914|NCT00725764|Secondary|Duration of Progression-free Survival|Progression-free survival was defined as the duration from the date of first dose to the date of disease progression or date of death without documented progression or date of study termination + 1. The start of confounding anticancer therapy was not treated as a censoring event. Time to progression or death was censored at the study termination date or at the analysis cutoff date, if earlier.|Approximately up to 1 year|Safety Population.|||Months||Full Range|Median
2771915|NCT00725764|Primary|Number of Participants With Abnormalities in Urinalysis|Urinalysis parameters like appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood were performed. Number of participants with abnormalities are reported. In case of no abnormalities observed then it is reported as zero.|Week 5 [Day 29]|Safety population.|||Participants|||Count of Participants
2771916|NCT00725764|Primary|Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology)|The National Cancer Institute -CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. Number of participants with abnormalities of CTCAE grade 3 in clinical chemistry parameters: alanine aminotransferase (ALT), γ-glutamyl transferase (GGT), phosphate, low sodium and hematology parameters: Leukocyte and Lymphocytes were presented.|Up to 20 months|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2771917|NCT00725764|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 20 months|Safety Population.|||Participants|||Count of Participants
2771918|NCT00725764|Primary|Percentage of Participants With Objective Response Rate (ORR)|ORR was defined as the proportion of participants achieving best overall response of confirmed CR or PR divided by the total number of participants who received treatment. Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Participants were evaluated for tumor response per RECIST. Percentage of participants with ORR were reported.|Approximately up to 1 year|Safety Population.|||Percentage of participants||95% Confidence Interval|Number
2771931|NCT00725725|Secondary|Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening|The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Screening|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.|||Participants|||Number
2771919|NCT00725764|Primary|Number of Participants Achieving Best Overall Response|Best overall response was assessed by the investigator per response evaluation criteria in solid tumors (RECIST). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Tumor size was recorded at Baseline, and tumor response were recorded approximately every 8 weeks. Tumor response were classified by the investigator using RECIST criteria participant's best response whether observed in the study treatment period or the treatment extension period was considered. The best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Number of participants who achieved best overall response were recorded.|Approximately up to 1 year|safety population comprised of all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.|||Participants|||Count of Participants
2771920|NCT00725751|Secondary|Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy|This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.|Day 1|Participants who received at least one dose of antiviral treatment.|||participants|||Number
2771921|NCT00725751|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)|All treated participants.|||participants|||Number
2771922|NCT00725751|Primary|Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin|For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 to 48 weeks|Participants who received at least one dose of PegIFN-2b/ribavirin|||participants|||Number
2771923|NCT00725725|Secondary|Number of Participants Discontinuing Study Therapy Due to AEs|The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 2 weeks|All treated participants are included in the safety analysis.|||Participants|||Number
2771924|NCT00725725|Secondary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 59 days|All treated participants are included in the safety analysis.|||Participants|||Number
2771925|NCT00725725|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|"The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 (very poor) to 5 (very good), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life)."|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.|||Q-LES-Q Score||Standard Deviation|Mean
2771926|NCT00725725|Secondary|Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score|The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.|||MADRS score||Standard Deviation|Mean
2771927|NCT00725725|Secondary|Change in Anxiety Sensitivity Index (ASI) Score|The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.|||ASI Score||Standard Deviation|Mean
2771928|NCT00725725|Secondary|Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score|The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.|||SIGH-A Score||Standard Deviation|Mean
2771929|NCT00725725|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score|The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.|||CGI-S Score||Standard Deviation|Mean
2771930|NCT00725725|Secondary|SCID-I/P With Psy Screen Score at EOT|The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.|||Participants|||Number
2771932|NCT00725725|Secondary|Change in PDSS Score From Baseline to Follow-Up|The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Follow-Up (Day 59)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.|||PDSS Score||Standard Deviation|Mean
2771933|NCT00725725|Secondary|Change in PDSS Score From Baseline to Visit 4|The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Visit 4 (Day 22)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.|||PDSS Score||Standard Deviation|Mean
2771934|NCT00725725|Primary|Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)|The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Day 36|The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.|||PDSS Score||Standard Deviation|Mean
2771935|NCT00725712|Secondary|Median Duration of Overall Survival (OS)of GSK1363089|Duration of OS is defined as (Date of Death [due to any cause]) minus Date of first dose. For the participants who were alive at the time of data cut-off, duration of overall survival was censored at the date of last contact. The upper value of the full range was censored observation.|At every 8 Weeks upto 31 months|Evaluable population|||months||Full Range|Median
2771936|NCT00725712|Secondary|Disease Stabilization Rate of GSK 1363089|It is defined as the number of participants achieving best overall response of confirmed CR or PR or stable disease (SD). It was assessed using RECIST criteria 1.0. The CR for target lesions was defined as disappearance of all TLs and the NTLs. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum LD since the treatment started.|At every 8 Weeks upto 31 months|Safety population|||percentage of participants||95% Confidence Interval|Number
2771937|NCT00725712|Secondary|Duration of Stable Disease of GSK1363089|Duration of stable disease, was defined as the time between the date of first dose and death or disease progression, in participants whose best overall response was not progressive disease|At every 8 Weeks upto 31 months|Evaluable population. Only those participants available at the specified time-points were analyzed.|||months||95% Confidence Interval|Median
2771938|NCT00725712|Secondary|Median Progression Free Survival (PFS) of GSK1363089|Duration of PFS in months is defined as (Date of Disease Progression/Death - Date of First Dose + 1)/30.44. For participants who did not reach an event (disease progression or death) at the time of data cut-off, duration of PFS is censored at date of last available tumor assessment that is not 'Unable to Evaluate'. For participants who did not have any post-baseline tumor assessments, PFS was censored at Day 1. For any participants who received subsequent anti-cancer therapy, PFS will be right censored at the date of last adequate tumor assessment on or prior to the date of anti-cancer therapy initiation. For any participants who died or progressed after an extended lost-to-follow-up time (greater than 17 weeks), PFS was censored at the date of last adequate assessment prior to extended lost-to follow-up.|At every 8 Weeks upto 31 months|Safety population|||months||95% Confidence Interval|Median
2771939|NCT00725712|Primary|Number of Participants Who Required Concomitant Medications|The number of participants who received concomitant medication during the study were reported. The data has been reported for the participants who have received subsequent chemotherapy, subsequent radiation therapy or other therapy.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population.|||Participants|||Count of Participants
2771940|NCT00725712|Primary|Number of Participants With Shift From Baseline by Grade for Hematology Parameters|The worst overall grading by CTCAE version 3.0, was used to report the shift from baseline for hematology parameters namely hemoglobin, platelets and lymphocytes. The grades were namely G0, G1, G2, G3 and G4. The data for shifts from G2 to G3 and G0 to G4, mainly the shifts to higher grades G3 and G4 have been reported.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2771941|NCT00725712|Primary|Number of Participants With Grade Shift for Urinalysis Parameters|The urinalysis parameters by worst case overall CTCAE grade shift post Baseline for each parameter were mentioned as per the CTCAE grading for version 3.0 and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for abnormal values for bilirubin, ketones, nitrites, occult blood, pH, protein, specific gravity, and urobilinogen.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified timepoints were reported.|||participants|||Number
2771942|NCT00725712|Primary|Number of Participants With Shift From Baseline by High/Low Flag for Hematology Paramaters|The hematology parameters worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. CTCAE grading for version 3.0 was used and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for basophils, eosinophils, erythrocytes, hematocrit, and monocytes were analyzed. Only the abnormal values were reported where normal to high and normal to low changes were reported. Worst Overall was defined as highest post baseline CTCAE grade before 30 day follow up.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2772723|NCT00721188|Secondary|Total Body Clearance (Cl)|Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)|Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.||||dL/hour||Standard Deviation|Mean
2771943|NCT00725712|Primary|Number of Participants With Shift From Baseline in Serum Chemistry- Graded|The worst overall common terminology criteria for adverse events version 3.0 (CTCAE) grade (G) shift post baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading is done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases, aspartate aminotransferases, Albumin, alkaline phosphatase, calcium, sodium, potassium, glucose, amylase, amylase, bilirubin, creatinine, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. Worst Overall defined as worst post baseline out of normal range flag in the order of (high, low, normal) before 30 day follow up. Data for G3 and G4 is reported.|From Day 1 to up to 30-day follow-up visit (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed .|||Participants|||Count of Participants
2771944|NCT00725712|Primary|Number of Participants With Shift From Baseline in by High/Low Flag for Serum Chemistry- Ungraded|The data for serum chemistry parameters like albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), amylase, aspartate amino transferase (AST), calcium, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, blood urea nitrogen (BUN), chloride, free thyroxine, free triiodothyronine, lipase, phosphorous, potassium, sodium, total bilirubin, lactate dehydrogenase, total protein. The abnormal values have been reported wherein data for normal to low and normal to high has been reported.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points we re analyzed.|||participants|||Number
2771945|NCT00725712|Primary|Change From Baseline in Respiratory Rate (RR)|The RR for the participant's, were collected after the participant sat quietly for at least five minutes. Baseline evaluations should be performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1 . The RR was measured in breaths per minute. Min and max post-baseline values are reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time-points were analyzed.|||breaths per minute||Standard Deviation|Mean
2771946|NCT00725712|Primary|Change From Baseline in Temperature|The body temperature for the participants was assessed. These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||degree celsius||Standard Deviation|Mean
2771947|NCT00725712|Primary|Change From Baseline in Vital Signs-Pulse Rate|The pulse rate or heart rate (HR) for the participant's, were collected after the participant sat quietly for at least five minutes. Baseline evaluations were performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1. The HR was measured in beats per minute (bpm). The min and max values have been reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
2771948|NCT00725712|Primary|Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The data for minimum (min) and maximum (max) post-baseline has been reported. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2771949|NCT00725712|Primary|Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered SAEs if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 31 months|Safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.|||participants|||Number
2771950|NCT00725712|Primary|Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|ORR is defined as the percentage of participants achieving best overall response of confirmed complete response (CR) or partial response (PR). Tumor response for participants with measurable lesions was assessed routinely (after 8 weeks of treatment and approximately every 8 weeks thereafter) using RECIST (version 1.0) criteria. The CR for target lesions was defined as disappearance of all target lesions (TLs) and the non-target lesions (NTLs). PR defined as at least 30% decrease in sum of the longest diameter (LD) of TLs, taking as reference baseline sum LD. The safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug. Progressive disease will be used as PD.|At every 8 Weeks upto 31 months|Evaluable population included participants from safety population who had received atleast 75% of protocol mandated doses at treatment period, had BL and post BL tumor assessment, with no extended lost to followup (17 wks or more) or who had received atleast 75% of protocol mandated doses at treatment period and discontinued study drug due to PD.|||participants|||Number
2772724|NCT00721188|Primary|Terminal Phase Elimination Rate Constant (λz)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||1/hour||Standard Deviation|Mean
2771951|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.|||Score on a scale||Standard Deviation|Mean
2771952|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.|||Score on a scale||Standard Deviation|Mean
2771953|NCT00725621|Primary|Median Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Full Range|Median
2771954|NCT00725621|Primary|Mean Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Standard Deviation|Mean
2771955|NCT00725621|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||mg/kg||Full Range|Median
2771956|NCT00725621|Secondary|Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|Some participants had more than one previous treatment with a DMARD.|24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.|||Participants|||Number
2771957|NCT00725621|Secondary|Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy||24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.|||Years||Standard Deviation|Mean
2771958|NCT00725621|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
2771959|NCT00725621|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Full Range|Median
2771960|NCT00725621|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Standard Deviation|Mean
2771961|NCT00725608|Secondary|Dispensing of Suboxone (Buprenorphine Plus Naloxone)|Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)|month 6, month 12|All participants with eligible datasets were included in the final analysis|||Participants|||Number
2771962|NCT00725608|Secondary|Dosing of Suboxone (Buprenorphine Plus Naloxone)|One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.|day 1, month 6, month 12|All participants with eligible datasets were included in the final analysis|||Dose of Suboxone® in mg||Standard Deviation|Mean
2771963|NCT00725608|Primary|Retention Rate|The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study|month 6, month 12|All eligible datasets were included in analysis population.|||percentage of patients||95% Confidence Interval|Number
2771964|NCT00725543|Primary|Median Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Full Range|Median
2771965|NCT00725543|Primary|Mean Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Standard Deviation|Mean
2771966|NCT00725543|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||mg/kg||Full Range|Median
2771967|NCT00725543|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
2771968|NCT00725543|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Full Range|Median
2772725|NCT00721188|Primary|Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug/dL||Standard Deviation|Mean
2771970|NCT00725530|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|7 days|All enrolled participants.|||Participants|||Number
2771971|NCT00725504|Primary|Present Pain Intensity|Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).|Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level||||Units on a scale||Standard Error|Mean
2771972|NCT00725491|Primary|The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.|The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.|At completion of ovarian stimulation; maximally after 18 days of recFSH administration.|The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.|||international units (IU)||Standard Deviation|Mean
2771973|NCT00725452|Secondary|Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab|BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.|Baseline and Infusion 9|Infliximab-naive participants who received Infliximab during the study.|||Percent of BSA involved with psoriasis||Standard Deviation|Mean
2771974|NCT00725452|Secondary|Median Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.|||mg/kg||Full Range|Median
2771975|NCT00725452|Secondary|Mean Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
2771976|NCT00725452|Secondary|Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.|||Days||Full Range|Mean
2771977|NCT00725452|Secondary|Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.|||Days||Standard Deviation|Mean
2771978|NCT00725452|Primary|Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab|"The types of therapies were assessed according to the following criteria:~Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days).~Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks).~Episodic Therapy: given out of time frame (> 12 weeks)."|Maximum 2 years|Infliximab-naive participants who received Infliximab during the study.|||Therapies|||Number
2771979|NCT00725361|Secondary|Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.|Range is 0-3 with 0 meaning the least amount of disability and 3 the greatest of disability.|24 weeks||||units on a scale||Standard Deviation|Mean
2771980|NCT00725361|Secondary|Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||Participants|||Count of Participants
2771981|NCT00725361|Secondary|Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||Participants|||Count of Participants
2771982|NCT00725361|Secondary|New DU 4 Weeks Prior to Week 12|The number of new DU that have developed in the preceding 4 weeks assessed at week 12 from baseline.|4 weeks prior to week 12|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||new digital ulcers||Standard Deviation|Mean
2771983|NCT00725361|Primary|New Digital Ulcers (DU) 4 Weeks Prior to Week 24|The number of new digital ulcers (DU) that have developed in the preceding 4 weeks assessed at week 24 from baseline.|4 weeks prior to week 24||||new digital ulcers||Standard Deviation|Mean
2771984|NCT00725322|Secondary|NRS Score Three Weeks After Injection|The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.|Three weeks after injection|Although 27 participants completed the study, 3 participants were excluded from analysis of the NRS score because they had missing data.|||Units on a scale||Standard Deviation|Mean
2771985|NCT00725322|Primary|Time Until Analgesic Failure|"Participants made daily NRS reports via Palm Pilot, and failure was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months"|Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline||||Days||Standard Deviation|Mean
2771986|NCT00725296|Primary|Median Dose of All Infusions Per Participant|The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.|||mg/kg||Full Range|Median
2771987|NCT00725296|Primary|Average Overall Dose of All Infusions Per Participant|The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.|||mg/kg||Standard Deviation|Mean
2776336|NCT00697593|Primary|Hematology - Monocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
2771988|NCT00725296|Primary|Median Dose During Induction Therapy and Subsequent Maintenance Therapy|The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||mg/kg||Full Range|Median
2771989|NCT00725296|Primary|Average Dose During Induction Therapy and Subsequent Maintenance Therapy|The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||mg/kg||Standard Deviation|Mean
2771990|NCT00725296|Primary|Median Time Interval Between Infusions During Maintenance Therapy|The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||days||Full Range|Median
2771991|NCT00725296|Primary|Mean Time Interval Between Infusions During Maintenance Therapy|The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||days||Standard Deviation|Mean
2771992|NCT00725283|Secondary|Number of Patients With Serious Adverse Events Related to Study Treatment|Serious adverse events (SAEs) assessed include medical occurrences related to treatment administration that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the CRF, but not as an SAE.|During the whole study duration (From Day 0 up to the concluding visit, at Month 49)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
2771993|NCT00725283|Secondary|Number of Patients With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include any medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the Clinical Report Form (CRF), but not as an SAE.|During the whole study duration (From Day 0 up to the concluding visit, at Month 49)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
2771994|NCT00725283|Secondary|Number of Patients With Any Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-administration period|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
2771995|NCT00725283|Primary|Number of Patients With Anti-WT1 Antibody Response|"Treatment response was defined as:~For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/ML; For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration."|At Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||Participants|||Count of Participants
2771996|NCT00725283|Primary|Concentrations for Anti-WT1 Antibodies|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).|At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||EU/mL||95% Confidence Interval|Geometric Mean
2772726|NCT00721188|Primary|Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug*hr/dL||Standard Deviation|Mean
2771997|NCT00725283|Primary|Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies|Seropostivity rate was defined as the number of patients with anti-WT1 antibody concentration greater than or equal to (≥) the cut-off value of 9 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).|At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||Participants|||Count of Participants
2771998|NCT00725283|Primary|Number of Patients With Severe Toxicities|"Severe toxicities (as classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related:~Grade 4 toxicity (exception: Grade 4 fatigue - including lethargy, asthenia, and malaise - had to have a duration of at least 48 hours to be taken into account).~Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration).~An allergic reaction/hypersensitivity Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition.~Decrease in renal function, with a calculated creatinine clearance < 40 mL/min.~Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina)."|During the study treatment period (From Day 0 to Month 48)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
2771999|NCT00725270|Primary|Change in Mood Symptoms|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.|Baseline and Day 9||||units on a scale||Standard Deviation|Mean
2772000|NCT00725270|Primary|Change in Positive Psychotic Symptoms Over the Course of Treatment|Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms|8 days||||units on a scale||Standard Deviation|Mean
2772001|NCT00725205|Secondary|Number Of Participants Self-Administering Pegylated Interferon Alfa-2b|Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.|Up to 48 Weeks|All Participants enrolled.|||Participants|||Number
2772002|NCT00725205|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.|24 Weeks following completion of 24 or 48 weeks of therapy|Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.|||Participants|||Number
2772003|NCT00725205|Primary|Number of Participants Who Are Triple-80 Compliant|Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.|24 or 48 Weeks|"All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being “treatment~failure”. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12."|||Participants|||Number
2772004|NCT00725153|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|10 hours|All enrolled participants.|||Participants|||Number
2772005|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)|Participant productivity was described as the number of days a participant missed work due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
2772006|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)|Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
2772007|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)|Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
2772008|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)|Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
2772009|NCT00725101|Secondary|Number of Days of Partial Care for Fibromyalgia (FM) Participants|Partial (day or night) care included day care, day nursing home, and partial hospitalization.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
2772010|NCT00725101|Secondary|Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.|||ER visits||Standard Deviation|Mean
2772011|NCT00725101|Secondary|Number of Outpatient Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.|||outpatient visits||Standard Deviation|Mean
2772012|NCT00725101|Secondary|Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months|The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
2772013|NCT00725101|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months|FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
2772014|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months|BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
2772015|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months|Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
2772016|NCT00725101|Secondary|Hazard Ratios for Factors Associated With Discontinued Opioid Use|Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.|Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.|||hazard ratio|||Number
2772017|NCT00725101|Secondary|Percentage of Participants Who Discontinued Opioids||Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.|||percentage of participants|||Number
2772018|NCT00725101|Secondary|Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study|Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.|Baseline through 12 months|The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.|||participants|||Number
2772019|NCT00725101|Primary|Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use|Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.|||odds ratio||95% Confidence Interval|Number
2772020|NCT00725101|Primary|Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication|Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.|||odds ratio||95% Confidence Interval|Number
2772021|NCT00725101|Primary|Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months||Baseline through 12 months|The analysis population included enrolled participants who took part in all follow-up interviews.|||medications||Standard Deviation|Mean
2772022|NCT00725075|Secondary|Change From Baseline in Extrapyramidal Symptoms Rating Scale Score at Week 12|The abbreviated Extrapyramidal Symptoms Rating Scale (ESRS-A) was a sum of the severity rating of a 24-item instrument assessing four types of movement disorders: parkinsonism, dystonia, dyskinesia, and akathisia. Each item was rated on a 7-point scale, from 0=absent to 6=severe. Higher scores indicated more impairment. A negative change from baseline indicated an improvement.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy.|||Score on a Scale||Standard Deviation|Mean
2772023|NCT00725075|Secondary|Change From Baseline in Composite Memory Score at Week 12|Composite memory was a composite of verbal memory and visual memory and was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772024|NCT00725075|Secondary|Change From Baseline in Executive Functioning Score at Week 12|Executive functioning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Shifting Attention Test. The participant matched geometric shapes either by shape or color. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772025|NCT00725075|Secondary|Change From Baseline in Sustained Attention Score at Week 12|Sustained attention was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was asked to identify a target shape/color when presented with a battery of different geometric shapes/colors. Only Parts 2 to 4 of the 4 Part Continuous Performance Test contributed towards the sustained attention score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772026|NCT00725075|Secondary|Change From Baseline in Working Memory Score at Week 12|Working memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was presented with targets and remembered target presentation sequencing in order to respond to the directions. Only Part 4 of the 4 Part Continuous Performance Test contributed towards the working memory score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772027|NCT00725075|Secondary|Change From Baseline in Speed of Complex Information Processing Score at Week 12|Speed of complex information processing was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Symbol-digit Coding Test. The participant linked numbers to digits. The test consisted of serial presentations of screens, each containing a bank of 8 symbols above and 8 empty boxes below. The participant typed the number that corresponded to the symbol highlighted. The raw score was the processing time in milliseconds. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772028|NCT00725075|Secondary|Change From Baseline in Visual Memory Score at Week 12|Visual memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 geometric figures within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Sore on a Scale||Standard Deviation|Mean
2772029|NCT00725075|Secondary|Change From Baseline in Verbal Memory Score at Week 12|Verbal memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 words within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772030|NCT00725075|Secondary|Change From Baseline in Non-Verbal Reasoning Score at Week 12|Non-verbal reasoning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant solved 15 visual analogies composed of geometric 2x2, 3x3, or 4x4 puzzles by choosing the most appropriate geometric figure that solved the matrix. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772031|NCT00725075|Secondary|Change From Baseline in Perception of Emotions Score at Week 12|Perception of emotion was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant identified different emotional states (happy, sad, angry, and calm [neutral]) presented in pictures of faces by choosing the appropriate word for the emotion. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772032|NCT00725075|Secondary|Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) at Week 12|CDSS was a 9-item clinician-rated instrument used to evaluate depression in participants who have schizophrenia. For each item, symptom severity was rated on a 4-point scale, from 0=absent to 3=severe, with a total scoring range of 0 to 27. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772033|NCT00725075|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Schizophrenia at Week 12|PANSS was a 30-item clinician-rated instrument used for assessing the positive, negative, and general psychopathology symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme, with a total scoring range of 30 to 210. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772034|NCT00725075|Primary|Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score) at Week 12|SANS was a 25-item clinician-rated instrument for assessing the negative symptoms of schizophrenia. SANS 1-22 Composite Score consisted of the SANS 25 scale minus the last 3 questions (attention items). The remaining non-attention items (affective flattening, alogia, avolition-apathy, and anhedonia-asociality) comprised the SANS 1-22 Composite Score. For each item, symptom severity was rated on a 6-point scale, from 0=absent to 5=severe. The SANS 1-22 Composite Score had a total scoring range of 0 to 110. Higher scores indicated more impairment. The SANS 1-22 Composite Score was reported using data from the adjusted site rater. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
2772035|NCT00725049|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.|3 years|Number of participants used in analysis selected as per protocol|||participants|Dental implants||Number
2772036|NCT00725010|Primary|Number of Participants Who Discontinued Due to Toxicity||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase||||Participants|||Number
2772037|NCT00725010|Primary|Safety: Number of Adverse Events in the Indicated Categories||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase||||Adverse Events|||Number
2772038|NCT00724984|Primary|Phase II: Overall Response Rate (CR+PR)||From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles||||Percentage of Participants||95% Confidence Interval|Number
2772039|NCT00724984|Primary|Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response|Number of patients experienced DLT in each cohort|From the Date of PCI-24781 first administration to Cycle 2 Day 1||||participants|||Number
2772040|NCT00724971|Other Pre-specified|Number of Participants With Positive Serum Antibody to Rituximab|Antibody responses to rituximab|Up to 8 Cycles (1 cycle = 28 days)|The intent-to-treat (ITT) population included all participants in the intended dose scheme.|||Participants|||Count of Participants
2772041|NCT00724971|Other Pre-specified|Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544)|Antibody responses to CMC-544|Up to 8 Cycles (1 cycle = 28 days)|The intent-to-treat (ITT) population included all participants in the intended dose scheme.|||Participants|||Count of Participants
2772042|NCT00724971|Other Pre-specified|Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544|Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.|||L||Standard Deviation|Mean
2772043|NCT00724971|Other Pre-specified|Clearance (CL) of CMC-544, Total Calicheamicin, and G544|The rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544|Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.|||L/hour||Standard Deviation|Mean
2772044|NCT00724971|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544|AUC∞ = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544|Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.|||ng*hour/mL||Standard Deviation|Mean
2772045|NCT00724971|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544|AUClast= Area under the serum concentration versus time curve from time zero (pre-dose) to time of last measured concentration.|Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544|Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.|||ng*hour/mL||Standard Deviation|Mean
2772101|NCT00724893|Secondary|Number of Participants Achieving RVR by Gender (Stage 2)|"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
2772046|NCT00724971|Other Pre-specified|Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544|The time measured for the serum concentration to decrease by one half.|Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544|Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.|||hours||Standard Deviation|Mean
2772047|NCT00724971|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)|CMC-544 is composed of G544, an anti-human CD22 antibody, linked to a potent cytotoxic antitumor antibiotic called calicheamicin. CD22 is expressed on the malignant cells of the majority of B-lymphocyte malignancies.|Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544|Phamacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit.|||ng/mL||Standard Deviation|Mean
2772048|NCT00724971|Secondary|Progression-Free Survival (PFS)|The interval from the date of first administration of the test article until the first date on which relapsed disease, progressive disease (PD), or death was documented, censored at the last tumor evaluation date. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: Relapse/PD, appearance of any new lesion or increased by >=50% in the size.|Up to 591 days|The evaluable population included all participants who received at least 2 doses of the test article and who had a baseline tumor computed tomography (CT) scan and underwent at least 1 postbaseline tumor assessment for anticancer clinical activity.|||weeks||95% Confidence Interval|Median
2772049|NCT00724971|Secondary|Number of Participants With Objective Response: Intent-to-treat (ITT) Population|Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or >75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or >=50% decrease in the SPD.|Up to 8 cycles (1 cycle = 28 days)|The ITT population included all participants who were enrolled in the intended dose scheme.|||Participants|||Count of Participants
2772050|NCT00724971|Secondary|Number of Participants With Objective Response: Evaluable Population|Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or >75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or >=50% decrease in the SPD.|Up to 8 cycles (1 cycle = 28 days)|The evaluable population included all participants who received at least 2 doses of the test article and who had a baseline tumor CT scan and underwent at least 1 postbaseline tumor assessment for anticancer clinical activity.|||Participants|||Count of Participants
2772051|NCT00724971|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting >=7 days, 4) Grade 4 thrombocytopenia lasting >=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade <=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose >2 weeks|Up to 28 days|The first cohort was analyzed for DLT.|||Participants|||Count of Participants
2772052|NCT00724958|Primary|Total Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.|||mg/kg||Standard Deviation|Mean
2772053|NCT00724958|Primary|Median Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||mg/kg||Full Range|Median
2772054|NCT00724958|Primary|Average Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||mg/kg||Standard Deviation|Mean
2772055|NCT00724958|Secondary|Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.|HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).|5 years|207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)|||Score on a scale||Standard Deviation|Mean
2772056|NCT00724958|Primary|Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||Days||Full Range|Median
2772057|NCT00724958|Primary|Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||Days||Standard Deviation|Mean
2772058|NCT00724945|Primary|Subject Vision|"Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|after 1 week wear||||Scores on a scale||Standard Error|Least Squares Mean
2772059|NCT00724945|Primary|Near Visual Acuity|This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.|after 1 week wear||||logMAR units||Standard Error|Least Squares Mean
2772060|NCT00724945|Primary|Distance Visual Acuity|This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal|after 1 week of wear|Analysis includes participants who completed the study per protocol.|||logMAR units||Standard Error|Least Squares Mean
2772061|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.|From signing of informed consent to end of trial (7 days after surgery)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
2772062|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs|"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.~Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration."|From signing of informed consent to end of trial (7 days after surgery)|The All-Subjects-Treated (AST) Population consisted of all randomized participants who received IMP.|||participants|||Number
2772063|NCT00724932|Other Pre-specified|Time From PACU Admit to Actual PACU Discharge|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From PACU admit to actual PACU discharge (up to ~4.3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772064|NCT00724932|Other Pre-specified|Time From PACU Admit to PACU Discharge Ready|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From PACU admit to PACU discharge ready (up to ~25 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772065|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to Actual PACU Discharge|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772066|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to PACU Discharge Ready|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772067|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual PACU Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772115|NCT00724893|Secondary|Number of Participants Achieving RVR by Race (Stage 2)|"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no."|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
2772068|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772069|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Actual Operating Room Discharge|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From tracheal extubation to actual OR discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772070|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Operating Room Discharge Ready|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From tracheal extubation to Operating Room discharge ready (up to ~1 minute)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772071|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Actual Operating Room Discharge|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772072|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Operating Room Discharge Ready|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772073|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Tracheal Extubation|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.|From start of IMP administration to tracheal extubation (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772074|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90|The time of IMP administration was defined as the actual time at which IMP administration was started.|From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Data not collected. In Protocol Amendment 2, this outcome measure was removed.||||||
2772075|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual Operating Room Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772076|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Actual Operating Room Discharge|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room admission to actual Operating Room discharge (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772077|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Operating Room Discharge Ready|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.|From Operating Room admission to Operating Room discharge ready (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2772078|NCT00724932|Other Pre-specified|Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study|Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.|Up to 30 days after IMP administration|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
2772079|NCT00724932|Other Pre-specified|Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites|The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.|Up to PACU discharge (up to ~4.5 hours)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
2772080|NCT00724932|Other Pre-specified|Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium|Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.|Up to 7 days after IMP administration|The AST Population consisted of all randomized participants who received sugammadex. Participants who received neostigmine were excluded from this analysis.|||participants|||Number
2772081|NCT00724932|Other Pre-specified|Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)|Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.|Up to 24 hours after IMP administration|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
2772082|NCT00724932|Other Pre-specified|Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.|Up to 30 minutes after IMP administration|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||participants|||Number
2772083|NCT00724932|Other Pre-specified|Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events|Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.|From induction of anesthesia to recovery from NMB (up to ~3 hours)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
2772084|NCT00724932|Other Pre-specified|Number of Participants Who Had Physical Examinations|Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).|At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP. As there was no specific physical examination case report form used in this study, data on whether or not a physical examination was conducted were not recorded.||||||
2772085|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.|||minutes||95% Confidence Interval|Geometric Mean
2772086|NCT00724932|Other Pre-specified|Mean Heart Rate|Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||beats per minute||Standard Deviation|Mean
2772087|NCT00724932|Other Pre-specified|Mean Diastolic Blood Pressure|Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||mm Hg||Standard Deviation|Mean
2772088|NCT00724932|Other Pre-specified|Mean Systolic Blood Pressure|Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||mm Hg||Standard Deviation|Mean
2772089|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group|The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.|From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received neostigmine and had at least one efficacy measurement. The participants who received sugammadex were not included in this analysis.|||minutes||95% Confidence Interval|Geometric Mean
2772349|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 2)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
2772090|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group|The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.|From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)|The ITT Population consisted of all randomized participants who received sugammadex and had at least one efficacy measurement. The participants who received neostigmine were not included in this analysis.|||minutes||95% Confidence Interval|Geometric Mean
2772091|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.|From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times from administration of last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9.|||minutes||95% Confidence Interval|Geometric Mean
2772092|NCT00724932|Other Pre-specified|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times to recovery of the T4/T1 ratio to 0.5 and 0.6.|||minutes||95% Confidence Interval|Geometric Mean
2772093|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.|||minutes||95% Confidence Interval|Geometric Mean
2772094|NCT00724932|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)|The Intent-To-Treat (ITT) Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
2772095|NCT00724893|Secondary|Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)|"Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered always or most of the time to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|Participants who completed the MAQ questionnaire during the study and achieved SVR|||percentage of participants|||Number
2772096|NCT00724893|Secondary|Number of Participants Achieving SVR by HIV Status (Stage 2)|"SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|This analysis was not done.||||||
2772097|NCT00724893|Secondary|Number of Participants Achieving EVR by HIV Status (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 12|This analysis was not done.||||||
2772098|NCT00724893|Secondary|Number of Participants Achieving RVR by HIV Status (Stage 2)|"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no."|Week 4|This analysis was not done.||||||
2772099|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 2)|"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772100|NCT00724893|Secondary|Number of Participants Achieving EVR by Gender (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772102|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)|"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772103|NCT00724893|Secondary|Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype."|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772104|NCT00724893|Secondary|Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)|"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype."|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
2772105|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 2)|"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772106|NCT00724893|Secondary|Number of Participants Achieving EVR by Weight (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772107|NCT00724893|Secondary|Number of Participants Achieving RVR by Weight (Stage 2)|"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 4|The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
2772108|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)|"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly)."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772109|NCT00724893|Secondary|Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly)."|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772110|NCT00724893|Secondary|Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)|"RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly)."|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
2772111|NCT00724893|Secondary|Number of Participants Achieving EVR Who Achieved SVR (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no."|Week 12|All participants who took at least one dose of study medication and achieved EVR|||participants|||Number
2772112|NCT00724893|Secondary|Number of Participants Achieving RVR Who Achieved SVR (Stage 2)|"RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no."|Week 4|Participants who achieved RVR|||participants|||Number
2772113|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 2)|"SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772114|NCT00724893|Secondary|Number of Participants Achieving EVR by Race (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772116|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 2)|"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no."|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772117|NCT00724893|Secondary|Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)|"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no."|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
2772118|NCT00724893|Secondary|Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5|||Participants|||Number
2772119|NCT00724893|Secondary|Relapse Rate by HCV Genotype (Stage 1)|"The relapse rate was calculated with these parameters: EOT yes, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 48 weeks|"All participants who took at least one dose of study medication (ITT population) and had EOT yes and valid EVR evaluation ; no participants had Genotype 5"|||Percentage of Participants|||Number
2772120|NCT00724893|Secondary|Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)|"EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Week 12|The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5|||Participants|||Number
2772121|NCT00724893|Secondary|Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)|"EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||particpants|||Number
2772122|NCT00724893|Secondary|Number of Participants With End of Treatment (EOT) Response (Stage 1)|"EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no."|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
2772123|NCT00724893|Secondary|Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772124|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772125|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772126|NCT00724893|Secondary|Number of Participants Achieving SVR by EVR Type (Stage 1)|"EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.|||participants|||Number
2772127|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 1)|"EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response no."|From Week 10 to Week 14|The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.|||participants|||Number
2772189|NCT00724750|Secondary|Average Cost of Supplies and Rental|Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).|Participants were followed for the duration of inpatient stay, an average of 5 days.||||dollars||Standard Deviation|Mean
2772128|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
2772129|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
2772130|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
2772131|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772132|NCT00724893|Secondary|Number of Participants Achieving SVR by Viral Load (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL)."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772133|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772134|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly)."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772135|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)|"Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly)."|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
2772136|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)|"Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals."|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population).|||Participants|||Number
2772137|NCT00724893|Secondary|The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no."|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data|||participants|||Number
2772138|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|"Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no."|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data|||Participants|||Number
2772139|NCT00724893|Secondary|Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no."|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
2772140|NCT00724893|Secondary|Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|"Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no."|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
2772141|NCT00724893|Secondary|Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)|"Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no."|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
2772142|NCT00724893|Secondary|Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772143|NCT00724893|Primary|Number of Participants Achieving SVR (Stage 2)|"SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772144|NCT00724893|Primary|Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)|"This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
2772145|NCT00724893|Primary|Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)|"This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no."|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
2772146|NCT00724893|Primary|Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)|"This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response no."|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
2772147|NCT00724867|Secondary|Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Percentage of Participants|||Number
2772148|NCT00724867|Secondary|Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
2772164|NCT00724867|Primary|Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Millimeters of mercury||Standard Deviation|Mean
2772149|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints|The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
2772150|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point|The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
2772151|NCT00724867|Secondary|Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points|Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change >0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Percentage of Participants|||Number
2772152|NCT00724867|Secondary|Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value - Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage change||Full Range|Median
2772153|NCT00724867|Secondary|Observed B-cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Cell count||Full Range|Median
2772154|NCT00724867|Secondary|Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with >= 50% reduction in proteinuria among participants with Baseline proteinuria >0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage of Participants|||Number
2772155|NCT00724867|Secondary|Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.|Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage of Participants|||Number
2772172|NCT00724867|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Grams per liter||Standard Deviation|Mean
2772156|NCT00724867|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligrams per decilitre (mg/dL) and C4 <16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value - Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percent Change||Full Range|Median
2772157|NCT00724867|Secondary|Observed Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligram per deciliter (mg/dL) and C4 <16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Milligrams per deciliter||Full Range|Median
2772158|NCT00724867|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.|Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value - Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage change||Full Range|Median
2772159|NCT00724867|Secondary|Observed Anti-double Stranded DNA Levels at Indicated Time Points.|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA >=30 International Units/milliliter [IU/mL]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||International units per milliliter||Full Range|Median
2772160|NCT00724867|Secondary|Percentage of Participants Achieving SRI Response at Indicated Time Points|The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MIIT Population|||Percentage of Participants|||Number
2772161|NCT00724867|Secondary|Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.|Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (<0.5 nanograms per milliliter [ng/mL]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 392|MITT Population|||Participants|||Number
2772162|NCT00724867|Primary|Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population. Only those subjects with abnormal (>124 umol/L) creatinine at baseline by year interval.|||Percentage of Participants|||Number
2772163|NCT00724867|Primary|Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Percentage of Participants|||Number
2772181|NCT00724854|Secondary|Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR|Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.|Treatment Week 48 and Treatment Week 72|Participants who achieved RVR at Treatment Week 4.|||Participants|||Number
2772165|NCT00724867|Primary|Number of Participants With the Indicated Immunogenic Response|Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Participants|||Number
2772166|NCT00724867|Primary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Units per liter||Standard Deviation|Mean
2772167|NCT00724867|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Ratio||Standard Deviation|Mean
2772168|NCT00724867|Primary|Change From Baseline in Creatinine Clearance at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Milliliters per second||Standard Deviation|Mean
2772169|NCT00724867|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Micromoles per liter||Standard Deviation|Mean
2772170|NCT00724867|Primary|Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Millimoles per liter||Standard Deviation|Mean
2772171|NCT00724867|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Grams per liter||Standard Deviation|Mean
2772182|NCT00724854|Secondary|Number of Participants With RVR Who Also Achieved SVR|RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.|Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)|Participants who achieved RVR at Treatment Week 4.|||Participants|||Number
2772183|NCT00724854|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.|Assessed at 24 weeks post-treatment||||Participants|||Number
2772173|NCT00724867|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Percentage||Standard Deviation|Mean
2772174|NCT00724867|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Trillions cells per liter||Standard Deviation|Mean
2772175|NCT00724867|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Billion cells per liter||Standard Deviation|Mean
2772176|NCT00724867|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Seconds||Standard Deviation|Mean
2772177|NCT00724867|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to Week 440|MITT Population|||Adverse events/100 participant-years|||Number
2772178|NCT00724867|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up Week 440|MITT Population|||Adverse events/100 participant-years|||Number
2772179|NCT00724867|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|Up to Week 440|Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.|||Participants|||Number
2772180|NCT00724854|Secondary|Assessment of Baseline Characteristics in Participants With SVR|Baseline characteristics assessed were age, gender, and genotype.|24 Weeks post-treatment|Participants with SVR|||Participants|||Number
2772184|NCT00724854|Primary|Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment|Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.|Assessed at Treatment Week 4||||Participants|||Number
2772190|NCT00724750|Secondary|Pain Score With Dressing Changes|Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.|Participants were followed for the duration of inpatient stay, an average of 5 days.||||units on a scale||95% Confidence Interval|Mean
2772191|NCT00724750|Secondary|Average Time Spent on Dressing Changes|Time was measured from the start of the dressing change until the initiation of suction.|Participants were followed for the duration of inpatient stay, an average of 5 days.||||minutes||Standard Deviation|Mean
2772192|NCT00724750|Secondary|Failure to Maintain Dressing Because of Fluid or Suction Leaks||Participants were followed for the duration of inpatient stay, an average of 5 days.||||participants|||Number
2772193|NCT00724750|Primary|Percent Change Per Day in Wound Volume|Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days||||% change per day||95% Confidence Interval|Mean
2772194|NCT00724750|Primary|Percent Change Per Day in Wound Surface Area|Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days||||% change per day||95% Confidence Interval|Mean
2772195|NCT00724711|Secondary|Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Participants Enrolled after Amendment 3~Missing = Excluded"|||pg/mL||Standard Deviation|Mean
2772196|NCT00724711|Secondary|Change From Baseline Fibrinogen at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"|||mg/dL||Standard Deviation|Mean
2772197|NCT00724711|Secondary|Change From Baseline C-Reactive Protein at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"|||mg/dL||Standard Deviation|Mean
2772198|NCT00724711|Secondary|Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||Ratio||Standard Deviation|Mean
2772199|NCT00724711|Secondary|Change From Baseline Fasting Lipid Parameters at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mg/dL||Standard Deviation|Mean
2772200|NCT00724711|Secondary|Change From Baseline Fasting Glucose at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mg/dL||Standard Deviation|Mean
2772201|NCT00724711|Secondary|Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mL/min/1.73m^2||Standard Deviation|Mean
2772202|NCT00724711|Secondary|Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.|||mL/min||Standard Deviation|Mean
2772203|NCT00724711|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"ITT Analysis Set~Missing = Excluded: Participants with missing values were excluded from this analysis"|||cells/microliter||Standard Deviation|Mean
2772204|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 50 copies/mL~Virologic Success: Last available HIV-1 RNA < 50 copies/mL in Week 48 window on randomized treatment"|||percentage of participants|||Number
2772205|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 200 copies/mL~Virologic Success: Last available HIV-1 RNA < 200 copies/mL in the Week 48 window while on randomized treatment"|||percentage of participants|||Number
2772206|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set|||percentage of participants|||Number
2772207|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set|||percentage of participants|||Number
2772233|NCT00724464|Primary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.|||Participants|||Number
2772208|NCT00724711|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm|The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.|||percentage of participants|||Number
2772209|NCT00724698|Primary|Adverse Events|Number of adverse events reported|Final Visit (Day 15)||||adverse events reported|||Number
2772210|NCT00724594|Secondary|Cytokine Level IL-1Ra in Plasma|anti-inflammatory cytokine Interleukin -1 Receptor alpha (IL-1Ra)|after N-acetylcysteine infusion||||IL-1Ra pg/ml||Inter-Quartile Range|Median
2772211|NCT00724594|Secondary|Magnetic Resonance Spectroscopy of Infants||36 - 40 weeks gestational age||||ratio of myoInositol/NAA in basal gangli||Standard Deviation|Mean
2772212|NCT00724594|Primary|Prothrombin Time|prothrombin clotting time|after N-acetylcystiene or saline infusion||||seconds||Standard Deviation|Mean
2772213|NCT00724594|Primary|Cerebral Blood Flow|Resistive index in middle cerebral artery (MCA)|after NAC infusion|blood flow resistive indices after first dose of N-acetylcysteine or saline|||ratio||95% Confidence Interval|Mean
2772214|NCT00724594|Primary|Maternal and Infant Mean Blood Pressure Change||Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing|The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.|||mmHg||Standard Deviation|Mean
2772215|NCT00724594|Primary|Placental Transfer Ratio|Ratio of NAC concentration in cord to maternal venous blood|At time of delivery||||ratio||Standard Deviation|Mean
2772216|NCT00724594|Primary|NAC Concentrations||Peak: 30 minutes after NAC infusion. Cord: at delivery||||micromol/L||Standard Deviation|Mean
2772217|NCT00724594|Primary|NAC Total Body Clearance||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||mL/h/kg||Standard Deviation|Mean
2772218|NCT00724594|Primary|NAC Volume of Distribution||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||L/kg||Standard Deviation|Mean
2772219|NCT00724594|Primary|NAC Terminal Elimination Half-life||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||hours||Standard Deviation|Mean
2772220|NCT00724568|Secondary|The Percentage of Patients That Achieved Partial or Complete Response to Treatment.|"Partial Response:~50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.~If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.~50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.~No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).~Complete Response:~Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.~<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.~No increase in the size or number of lytic bone lesions."|24 weeks (8, 21-day cycles)|74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.|||percentage of patients|||Number
2772221|NCT00724568|Primary|Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)|"Dose Level 1:~15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 2:~20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 3:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 4:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4"|1 month post treatment|A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.|||mg|||Number
2772222|NCT00724503|Secondary|Percentage of Participants With Overall Response|Tumour Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR) - Disappearance of all target lesions which is confirmed if determined by two observations not less than 4 weeks apart; Partial Response (PR) - >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Through study completion, up to 60 months||||percentage of participants|||Number
2772223|NCT00724503|Primary|Progression-Free Survival (PFS) at Any Site|PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|ITT population|||Months||95% Confidence Interval|Median
2772224|NCT00724477|Primary|Number of Participants Reaching the Targeted LDL-C Levels|"A subject was considered to have met targeted LDL-C levels (been controlled) if:~subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,~subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,~subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,~subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,~subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L."|1 to 3 months after starting treatment|This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.|||Participants|||Number
2772225|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule|SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.|24 weeks following completion of 24 or 48 weeks of therapy|No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed.||||||
2772226|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants.|||Participants|||Number
2772227|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis.|||Participants|||Number
2772228|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants.|||Participants|||Number
2772229|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants.|||Participants|||Number
2772230|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants.|||Participants|||Number
2772231|NCT00724464|Primary|Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up|Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.|||Participants|||Number
2772232|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers.|||Participants|||Number
2772235|NCT00724451|Secondary|Number of Participants Discontinued From Treatment by Reason for Discontinuation|Investigators recorded reasons for treatment discontinuation.|24 weeks after the end of treatment (total of 48 to 72 weeks)|Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.|||participants|||Number
2772236|NCT00724451|Primary|Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility|Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.|Measured at baseline|431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.|||participants|||Number
2772237|NCT00724373|Primary|Participants With Treatment Success|Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).|Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.|Number of participants who had treatment success.|||Participants|||Number
2772238|NCT00724347|Primary|.Speech Discrimination Ability|Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.|Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..|older hearing impaired listeners with hearing aids.|||signal to noise ratio in dB SNR||Standard Deviation|Mean
2772239|NCT00724308|Secondary|VA Site-level Performance Rates on the VA Tobacco Performance Measures||Quarterly after study implementation|||||||
2772240|NCT00724308|Secondary|Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)||2 and 6 months after enrollment|||||||
2772241|NCT00724308|Secondary|Quit Attempt Rate||2 and 6 months after enrollment|||||||
2772242|NCT00724308|Secondary|30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)||2 months after enrollment|||||||
2772243|NCT00724308|Primary|Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)||6 months after enrollment||||participants|||Number
2772244|NCT00724282|Primary|Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test||at the end of each treatment|Investigator left university without analyzing data and no information is available on unblinding.||||||
2772245|NCT00724243|Primary|Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria|Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 14 and Week 54||||Participants|||Number
2772246|NCT00724243|Primary|Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|Baseline, Week 14, and Week 54|"Thirty-three participants had a DAS 28 score at the beginning of treatment.~Twenty-eight participants had a DAS 28 score at Week 14.~Twenty-two participants had a DAS 28 score at Week 54."|||Units on a Scale||Standard Deviation|Mean
2772247|NCT00724152|Secondary|Tinnitus Reaction Questionnaire (TRQ)|This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach's alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)|Period 1 and Period 2|||units on a scale ranging 0-104||Standard Deviation|Mean
2772248|NCT00724152|Primary|Tinnitus Handicap Inventory (THI)|"Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients' responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the no handicap range. This measure has strong internal consistency reliability (Cronbach's alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score."|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)|Period 1 and Period 2|||units on a scale of 0-100||Standard Deviation|Mean
2772315|NCT00723580|Secondary|The Personality Inventory for Children: Achievement Scale|The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
2772249|NCT00724126|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.|||percentage of responders|||Number
2772250|NCT00724126|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.|||percentage of responders|||Number
2772251|NCT00724061|Other Pre-specified|Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells||Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase|||||||
2772252|NCT00724061|Other Pre-specified|Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment|The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients.|At baseline and after 2 weeks of treatment (for those patients who consented to this portion)|||||||
2772253|NCT00724061|Secondary|To Evaluate the Duration of Response|To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.|At each study visit|No data collected for this outcome measure.||||||
2772254|NCT00724061|Secondary|Number of Patients Exhibiting a Complete Response|"Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease.~CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR."|During 12 weeks of dose escalation and then up to one year during maintenance therapy.|No data collected for this outcome measure.||||||
2772255|NCT00724061|Primary|Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM)|The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.|During 12 weeks of dose escalation and then up to one year during maintenance therapy.|No data collected for this outcome measure.||||||
2772256|NCT00724061|Primary|Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b|"Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity."|From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)||||dose limiting toxicities|||Number
2772257|NCT00724009|Secondary|Leukemia Free Survival|Time to event analysis used the day of transplant as day 0.|2 years|One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)|||days||95% Confidence Interval|Median
2772258|NCT00724009|Secondary|Number of Participants Infection Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
2772259|NCT00724009|Secondary|Number of Participants With Skin Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
2772260|NCT00724009|Secondary|Number of Participants With Cardiac Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
2772261|NCT00724009|Secondary|Number of Participants With Hepatic (SGOT) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
2772262|NCT00724009|Secondary|Number of Participants With Hepatic (Total Bilirubin) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
2772263|NCT00724009|Secondary|Number of Participants With Renal Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
2772264|NCT00724009|Primary|Cytoreductive Response|Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%|Day 12||||percentage of participants|||Number
2772350|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 3)|Heart rate was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
2772265|NCT00723957|Secondary|Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors|Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.|Randomization to death or last known alive date, up to 31.34 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
2772266|NCT00723957|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results|ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN|At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)|All participants who received any investigational product.|||Participants|||Number
2772267|NCT00723957|Secondary|Number of Participants With Hematology Laboratory Results of Grade 3 or 4|LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: <LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3: <2.0 to 1.0*10^9/L, Grade 4: <1.0*10^9/L; Neutrophils (neutropenia) Grade 1: <LLN to 1.5*10^9/L, Grade 2: <1.5 to 1.0*10^9/L, Grade 3: <1.0 to 0.5*10^9/L, Grade 4: <0.5*10^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0*10^9/L, Grade 2: <75.0 to 50.0*10^9/L, Grade 3: <50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L; Hemoglobin (anemia) Grade 1: <LLN to 10.0 g/dL, Grade 2: <10.0 to 8.0 g/dL, Grade 3: <8.0 to 6.5 g/dL, Grade 4: <6.5 g/dL.|At screening and weekly during 21-day cycle|All participants who received any investigational product.|||Participants|||Number
2772268|NCT00723957|Secondary|Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21, continuously|All participants who received any investigational product.|||Participants|||Number
2772269|NCT00723957|Secondary|Time to Response|Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])|Randomization to date of first response (PR or CR)|All randomized participants|||Weeks||Full Range|Median
2772270|NCT00723957|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)|Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles||||Percentage of participants||95% Confidence Interval|Mean
2772271|NCT00723957|Secondary|Progression-free Survival in the Overall Population|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death, assessed to 12.29 months|All randomized participants who received study drug|||Months||95% Confidence Interval|Median
2772272|NCT00723957|Secondary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death (maximum reached: 12.29 months)|All randomized participants who had βIII-tubulin positive tumors and who received study drug|||Months||95% Confidence Interval|Median
2772273|NCT00723957|Primary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.|Randomization to disease progression or death (maximum reached: 14.39 months )|All randomized participants with βIII-tubulin positive tumors and who received study drug|||Months||95% Confidence Interval|Median
2772274|NCT00723944|Secondary|Osseous Integration||4 years|||||||
2772275|NCT00723944|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.|||millimeters|implants|Standard Error|Mean
2772276|NCT00723931|Primary|Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold|Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection.||||Participants|||Number
2772351|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 2)|Heart rate was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
2772277|NCT00723931|Primary|Number of Participants That Reported a Serious Adverse Event|Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection||||Participants|||Number
2772278|NCT00723892|Secondary|the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol||12 months after onset of treatment|Participants with no missing results.|||Weeks||Standard Deviation|Mean
2772279|NCT00723892|Primary|Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.||12 months after onset of treatment|Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.|||Participants|||Number
2772280|NCT00723840|Primary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease|"EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.~EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.|||Score on a scale|||Number
2772281|NCT00723840|Primary|Cost of Illness in Participants With Crohn's Disease|"Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.~Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.|||Euros|||Number
2772282|NCT00723827|Primary|Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)|The response ratings were based on the judgment of the investigator.|Complete study duration (up to approximately 6.5 months)||||participants|||Number
2772283|NCT00723827|Primary|Number of Temozolomide Drug Interactions|Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||events|||Number
2772284|NCT00723827|Primary|Number of Temozolomide Misuse or Abuse Events|"Drug abuse was defined as the use of the study drug for a non-therapeutic effect.~Misuse was defined as use of the study medication in a way that was not prescribed."|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||Events|||Number
2772285|NCT00723827|Primary|Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)|An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||participants|||Number
2772286|NCT00723827|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||participants|||Number
2772287|NCT00723801|Secondary|Diastolic Function - Ejection Fraction|Two-dimensional echocardiography was performed using a 3.0 MHz transducer (General Electric VIVID 7). Left ventricular and left atrial dimensions were determined in parasternal long axis views. Left ventricular ejection fraction was calculated using the modified Simpsons calculation in the apical two and four chamber views.|Baseline and 6 months||||Change in % ejection fraction||Standard Deviation|Mean
2772288|NCT00723801|Primary|Aortic Biophysical Properties - Pulse Wave Velocity|Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal notch to the sites of carotid and femoral pulse acquisition were measured and inputted into the device to represent the relative distance from the carotid to femoral artery. The calculation of distance divided by time of pulse upstroke relative to the upstroke of the QRS on a 3 lead surface EKG was used by the device to calculate velocity. All recorded measurements met the manufacturer's quality control standards integrated into the software package.|Baseline and 6 months||||change in meters/second||Standard Deviation|Mean
2772289|NCT00723788|Primary|Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up|Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)|during diagnostic procedure|All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.|||participants|||Number
2772290|NCT00723749|Secondary|Drug Craving (Subjective Effects of Therapy)|Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)|Baseline and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||Units on a scale||Standard Deviation|Mean
2772352|NCT00723554|Primary|Heart Rate - Iloprost PD-6 (Period 1)|Heart rate was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population|||beats per minute||Standard Deviation|Mean
2772291|NCT00723749|Secondary|Take Home Prescriptions of SUBOXONE®|"Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.~Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.~A patient can receive only one take home prescription for up to 7 days at the time."|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||participants with take home prescription|||Number
2772292|NCT00723749|Primary|Retention Rate After 12 Months of Treatment With Suboxone|The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.|12 months|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||% of participants||95% Confidence Interval|Number
2772293|NCT00723749|Secondary|Dosage of SUBOXONE®|Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||mg daily dosage of Suboxone||Standard Deviation|Mean
2772294|NCT00723736|Primary|Proportion of Patients With Adverse Events|An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.|Follow-up visit at 3 - 5 weeks after treatment initiation||||participants|||Number
2772295|NCT00723710|Primary|Number of Participants Who Completed Treatment|Treatment completion was defined as those who completed both the induction and maintenance phases.|Up to 1 year|The number of participants who started the induction phase|||Participants|||Number
2772296|NCT00723697|Primary|Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.|Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|All eligible patients|||participants|||Number
2772297|NCT00723697|Secondary|Number of Patients Reporting Clinical Consequences of Engaging in Misuse|Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.|first visit, 6 months, and 12 months|Number of patients analyzed for the consequence, at each visit.|||participants|||Number
2772298|NCT00723697|Primary|Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)|Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|Number of patients with self-questionnaire responses.|||participants|||Number
2772299|NCT00723645|Secondary|Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)|"Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.~SVR was defined as negative for HCV RNA at Week 24 of follow-up."|From 24 weeks post-treatment to 72 weeks post-treatment|"The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2).~187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3)."|||Percentage of participants||95% Confidence Interval|Number
2772300|NCT00723645|Primary|Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)|"Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.~RNA= Ribonucleic Acid"|From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment|The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).|||Percentage of participants||95% Confidence Interval|Number
2772301|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Prior Treatment Status|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
2772316|NCT00723580|Secondary|The Personality Inventory for Children: Adjustment Scale|This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change.|May-7-2008 to July -14-2010|||||||
2772302|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Ribavirin Dosage|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
2772303|NCT00723632|Primary|Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
2772304|NCT00723606|Secondary|Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours|BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
2772305|NCT00723606|Secondary|Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
2772306|NCT00723606|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
2772307|NCT00723606|Secondary|Change From Baseline in BPRS Agitation Subscale Score at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
2772308|NCT00723606|Secondary|BPRS Agitation Subscale Response at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score.|72 hours|FAS. Missing data were replaced by last observation carried forward (LOCF).|||participants|||Number
2772309|NCT00723606|Primary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours|BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.|Baseline, 72 hours|Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner.|||scores on a scale||Standard Error|Least Squares Mean
2772310|NCT00723580|Secondary|The Personality Inventory for Children: Family Relations Scale|The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
2772311|NCT00723580|Secondary|The Personality Inventory for Children: Social Skills Scale|The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
2772312|NCT00723580|Secondary|The Personality Inventory for Children: Withdrawal Scale|The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function|May-7-2008 to July -14-2010|||||||
2772313|NCT00723580|Secondary|The Personality Inventory for Children: Delinquency Scale|The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May 7, 2008-July 14,2010|||||||
2772314|NCT00723580|Secondary|The Personality Inventory for Children: Somatic-Physiological Scale|The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
2772317|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Hyperactivity Observed||May-7-2008 to July -14-2010|||||||
2772320|NCT00723580|Secondary|Systematic Observation Scale Item: Percentage of Impulsivity Observed|The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.|May-7-2008 to July -14-2010|||||||
2772321|NCT00723580|Primary|Actigraphic Measurement of Treatment Conditions|The child's impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.|May 12- July 14, 2010|Single subject repeated Actigraphic(at thirty second intervals), observational (every two months) and psychometric (baseline and at 23 months) measurements of a child anticipating pharmacological treatment. Actigraphic measurements (three 21 day periods) over five treatment conditions that included a non-medication baseline and spanned 23 months.|||activity|Participants|Standard Deviation|Mean
2772322|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772323|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772324|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772325|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772326|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772727|NCT00721188|Primary|Serum Terminal Phase Elimination Half-life (T1/2)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
2772327|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772328|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772329|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772330|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772331|NCT00723554|Secondary|New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
2772332|NCT00723554|Secondary|Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
2772333|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
2772334|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
2772335|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
2772336|NCT00723554|Secondary|Change in Average Number of Daily Doses - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
2772337|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
2772338|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
2772339|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
2772340|NCT00723554|Secondary|Change in Average Number of Days of Dosing - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
2772341|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
2772342|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
2772343|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
2772344|NCT00723554|Secondary|Change in Average Inhalation Time - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
2772345|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
2772346|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
2772347|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
2772348|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 3)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
2772353|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 3)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772354|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 2)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772355|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 3)|Diastolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772356|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 2)|Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772357|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-6 (Period 1)|Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1||||mmHg||Standard Deviation|Mean
2772358|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 3)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772359|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 2)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772360|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 3)|Systolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772361|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 2)|Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
2772362|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-6 (Period 1)|Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population|||mmHg||Standard Deviation|Mean
2772363|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Serious AEs|Number of patients reporting at least one treatment-emergent serious AEs|From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population|||participants|||Number
2772364|NCT00723554|Primary|Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE|Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment|From the first dose of investigational product to study discontinuation, an average of approximately 268 days|Safety population|||participants|||Number
2772365|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Adverse Events (AEs)|Number of patients reporting at least one treatment-emergent AE/Serious AE|From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population|||participants|||Number
2772366|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.|||Percentage of participants|||Number
2772367|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.|||Percentage of participants|||Number
2772368|NCT00723528|Secondary|Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64|Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
2772369|NCT00723528|Secondary|Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64|The number of nails with psoriasis involvement was assessed by a dermatologist.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Nails||Standard Deviation|Mean
2772370|NCT00723528|Secondary|Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 12, 28, 40,52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
2772371|NCT00723528|Secondary|Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64|The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
2772372|NCT00723528|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
2772373|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
2772374|NCT00723528|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.|||Percentage of participants|||Number
2772375|NCT00723528|Secondary|Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.|||Percentage of treatment response||Standard Deviation|Mean
2772376|NCT00723528|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.|||Units on a scale||Standard Deviation|Mean
2772377|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 12|"The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on scale||Standard Deviation|Mean
2772378|NCT00723528|Primary|Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score|Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.|||Percentage of participants|||Number
2772379|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
2772380|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC -(AD) Compared to YFV-17D SC - (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
2772381|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
2772382|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC - (AD) Compared to YFV-17D SC - (Non- AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 - 35).|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
2772383|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters|||participants|||Number
2772384|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters|||participants|||Number
2772385|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||Log10 (NT50)||Standard Deviation|Mean
2772386|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC - (AD) Participants Compared to YFV-17D TC - (Non - AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||Log10 (NT50)||Standard Deviation|Mean
2772387|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC - (AD) Participants Compared to YFV-17D SC- (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)|All participants who completed the study; and seroconverted|||Log10 Neutralization Index (LNI)||Standard Deviation|Mean
2772388|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC- (AD) Participants Compared to YFV-17D TC- (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||LNI||Standard Deviation|Mean
2772408|NCT00723450|Secondary|Time From Randomization to Intervention for a Mood Episode (TIME)|The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for a mood episode (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
2772389|NCT00723450|Secondary|Change From Randomization in the Conners' Global Index - Parent Version (CGI-P) at Each Visit in the Randomized Phase.|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772390|NCT00723450|Secondary|Change From Baseline in the Conners' Global Index - Parent Version (CGI-P) at Each Visit in the Open-Label Phase|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772391|NCT00723450|Secondary|Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772392|NCT00723450|Secondary|Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772393|NCT00723450|Secondary|Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772394|NCT00723450|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772395|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase|"The CGI-BP(I) asks the following question: Compared to the Randomization assessment in this trial, how much has the participant changed?. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF)."|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Participants|||Number
2772396|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase|"The CGI-BP(I) asks the following question: Compared to the Baseline assessment in this trial, how much has the participant changed?. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF)."|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.|||Participants|||Number
2772397|NCT00723450|Secondary|Summary of Clinical Global Impressions - Bipolar - Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase|Improvement of bipolar illness was based on the CGI-BP(I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36|Randomized ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Randomized ITT Population.|||Scores on a scale||Standard Deviation|Mean
2772495|NCT00722865|Secondary|Overall Survival|Overall survival: patients are still alive.|2 years||||Participants|||Count of Participants
2772398|NCT00723450|Secondary|Summary of Clinical Global Impressions - Bipolar - Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase|Improvement of bipolar illness was based on the CGI-BP (I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.|||Scores on a scale||Standard Deviation|Mean
2772399|NCT00723450|Secondary|Change From Randomization in the Clinical Global Impressions - Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772400|NCT00723450|Secondary|Change From Baseline in the Clinical Global Impressions - Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772401|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772402|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772403|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology - Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2772404|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG.|||Scores on a Scale||Standard Error|Least Squares Mean
2772405|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase|The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed.|From randomization up to Week 36|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.|||Participants|||Number
2772406|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State|The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed.|From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.|||Participants|||Number
2772407|NCT00723450|Secondary|Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix)|The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
2772496|NCT00722865|Secondary|Progression-free Survival|Progression-free survival: a patient lives with the disease but it does not get worse.|2 years and medium follow-up of 18 months||||percentage of participants||90% Confidence Interval|Number
2772409|NCT00723450|Secondary|Time From Randomization to Withdrawal From the Study for Any Cause (TTW)|The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until withdrawal from the study for any cause (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
2772410|NCT00723450|Primary|Time From Randomization to the Occurrence of a Bipolar Event (TOBE)|TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until Week 36|Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product.|||Days||Standard Error|Mean
2772411|NCT00723398|Secondary|Changes in Complete Blood Count: White Blood Cells and Platelets|Changes in complete blood count levels as measured through white blood cells (WBC) and platelets. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||thousand cells/mL||Standard Deviation|Mean
2772412|NCT00723398|Secondary|Changes in Complete Blood Count: Hematocrit|Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||volume percentage||Standard Deviation|Mean
2772413|NCT00723398|Secondary|Changes in Complete Blood Count: Hemoglobin|Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||g/dL||Standard Deviation|Mean
2772414|NCT00723398|Secondary|Changes in Complete Blood Count: Red Blood Cells|Changes in complete blood count levels as measured through red blood cells (RBC). Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||millions of cells per microliter||Standard Deviation|Mean
2772415|NCT00723398|Secondary|Changes in Serum Lipid Levels|Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Specific time points for evaluation are baseline, Year +1, and Year 2.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||mg/dL||Standard Deviation|Mean
2772416|NCT00723398|Secondary|Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)|Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample. Specific time points for evaluation are baseline and Year +1 (only).|1 year|Measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 46).|||ng/mL||Standard Deviation|Mean
2772417|NCT00723398|Secondary|Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)|Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw. Specific time points for evaluation are baseline and Year +1 (only).|1 Year|Biomarker measurements were not taken for the entire population of the study (N = 266) due to non-significant trends for treatment effects found in this initial population (n = 89).|||pg/ml||Standard Deviation|Mean
2772418|NCT00723398|Secondary|Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)|Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis. Specific time points for evaluation are baseline and Year +1 (only).|1 year|Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).|||ng/mg creatinine||Standard Deviation|Mean
2772419|NCT00723398|Secondary|Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine|Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.|1 year|Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).|||ng/mg creatinine||Standard Error|Mean
2772420|NCT00723398|Secondary|Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α|Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-(isoprostane) F-2α as measured through urine analysis.|1 year|Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).|||pg/mg creatinine||Standard Error|Mean
2772421|NCT00723398|Primary|Change in Absolute Breast Density|Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.|2 years|The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.|||cm squared||Standard Deviation|Mean
2772422|NCT00723294|Secondary|Pain Assessment||Up to 14 days post surgery||2017-12-31|12/2017||||
2772423|NCT00723294|Secondary|Adverse Events||Up to 14 days post surgery||2017-12-31|12/2017||||
2772544|NCT00722020|Primary|The Primary Endpoint Will be Time to Readiness for Discharge.|Days in the hospital prior to patient being clinically ready to discharge|30 days|asthmatic children|||days||Standard Deviation|Mean
2772424|NCT00723294|Secondary|Negative Predictive Value of MRI|Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.|Up to 14 days post cryoablation|One patient had bilateral disease and therefore outcomes are reported for 87 cancers.|||percentage of cancers|cancers|90% Confidence Interval|Number
2772425|NCT00723294|Primary|Rate of Complete Tumor Ablation|The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).|Up to 14 days post surgery|One patient had bilateral disease and therefore outcomes are reported for 87 lesions.|||percentage of lesions|lesions|90% Confidence Interval|Number
2772426|NCT00723255|Secondary|Progression-free Survival at 6 Months by Tumor Grade|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
2772427|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
2772428|NCT00723255|Secondary|Progression-free Survival at 6 Months by Histologic Type|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
2772429|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
2772430|NCT00723255|Secondary|Progression-free Survival at 6 Months by Performance Status|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
2772431|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Performance Status|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
2772432|NCT00723255|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, up to 5 years|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
2772433|NCT00723255|Secondary|Progression-Free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
2772434|NCT00723255|Primary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Every cycle and 30 days after the last treatment, an average of 5 years.|Eligible and evaluable patients|||Participants|||Count of Participants
2772435|NCT00723255|Primary|Progression-free Survival at 6 Months|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2772436|NCT00723255|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2772437|NCT00723229|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours|9 weeks|Only episodes of known duration were included|||Hours|Episodes|Inter-Quartile Range|Median
2772438|NCT00723229|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs|9 weeks|The number of participants analyzed is the same as the overall number. No participants were excluded from this analysis.|||Episodes|||Number
2772439|NCT00723229|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|9 weeks|The number of swabs with HSV detected was analyzed. This is a subset of overall numbers of swabs collected, since not all swabs had HSV detected.|||log 10 copies/ml|Swabs|Inter-Quartile Range|Median
2772440|NCT00723229|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.||9 weeks|Participants collected at least one swab on each study arm|||percentage of swabs with HSV detected|Swabs||Number
2772728|NCT00721188|Primary|Time to Maximum Serum Concentration (Tmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
2772441|NCT00723203|Primary|Hematological Response Rate|Morphologic CR: morphologic leukemia-free state with absolute neutrophil count > 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (<1000/uL) and/or thrombocytopenia (<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value > 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.|Up to 6 cycles of treatment, up to 24 weeks.|Three patients of the 16 accrued were not included in the analysis for response per protocol due to patient refusal for alternative treatment prior to completing the first cycle of treatment.|||percentage of responding participants|||Number
2772442|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-I scale:~1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2772443|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-S scale:~1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2772444|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4||At baseline and at Week 4|Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||beats per minute||Standard Deviation|Mean
2772445|NCT00723190|Primary|Change From Baseline in Heart Rate at Week 4|Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||beats per minute||Standard Deviation|Mean
2772446|NCT00723190|Primary|Change From Baseline in Body Temperature at Week 4|Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Fahrenheit||Standard Deviation|Mean
2772447|NCT00723190|Primary|Change From Baseline in Systolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||mmHg||Standard Deviation|Mean
2772448|NCT00723190|Primary|Change From Baseline in Diastolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||mmHg||Standard Deviation|Mean
2772449|NCT00723190|Primary|Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12||At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Kilograms||Standard Deviation|Mean
2772450|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4||At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||milliseconds||Standard Deviation|Mean
2772451|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Events|||Number
2772452|NCT00723190|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12|The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
2772597|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772453|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Participants|||Number
2772454|NCT00723177|Secondary|The Effects of AV411 on the Analgesic Effects of Oxycodone.|The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.|Measured at the end of each AV411 of the three two-week maintenance periods||||units on a scale||Standard Deviation|Mean
2772455|NCT00723177|Primary|Subjective Opioid Withdrawal Scale Score (SOWS)|Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.|Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).|Only 30 of the total number of 44 enrolled completed the study .|||units on a scale||Standard Error|Mean
2772456|NCT00723125|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||2 years|||||||
2772457|NCT00723125|Primary|Pathological Complete Response Rates at Surgery||at surgery approximately 5 months after initial treatment|Cohort1: 33 pts enrolled to cohort 1,33 underwent surgery even if they did not complete all treatment Cohort 2: 27 enrolled to cohort 2 and 27 underwent surgery, even if they did not complete all treatment|||participants|||Number
2772458|NCT00723099|Secondary|Percent of Patients With Non-relapse Mortality|Kaplan-Meier and cumulative incidence estimates|1 year||||percent of patients|||Number
2772459|NCT00723099|Secondary|Percent of Patients With Non-relapse Mortality|Kaplan-Meier and cumulative incidence estimates|6 months||||percent of patients|||Number
2772460|NCT00723099|Secondary|Percent of Patients With Chronic GVHD|Kaplan-Meier and cumulative incidence estimates will be used to measure percent of patients with chronic GVHD by NIH consensus criteria.|At 2 years||||percent of patients|||Number
2772461|NCT00723099|Secondary|Percent of Patients With Acute GVHD Grades III-IV|Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria|100 days||||percent of patients|||Number
2772462|NCT00723099|Secondary|Percent of Patients With Grade II-IV Acute Graft Versus Host Disease|Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria|By day 100||||percent of patients|||Number
2772463|NCT00723099|Secondary|Time to Platelet Engraftment of > 20,000 Cells Per mm3|median and range|By 6 months||||days||Full Range|Median
2772464|NCT00723099|Secondary|Number of Participants With Graft Failure/Rejection|descriptive|By day 55||||participants|||Number
2772465|NCT00723099|Secondary|Median Time to ANC > 500||By day 55||||days||Full Range|Median
2772466|NCT00723099|Primary|Overall Survival|Kaplan-Meier and cumulative incidence estimates will be used.|At 1 year||||percent of patients|||Number
2772467|NCT00723073|Secondary|Duration of Neutropenia|Median number of days patients were neutropenic during the study period|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
2772468|NCT00723073|Secondary|Duration of Hospitization|Median number of days patients were hospitalized during the study period|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
2772469|NCT00723073|Secondary|Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation|The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy|11/1/2005 - 10/31/2007||||participants|||Number
2772470|NCT00723073|Secondary|Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy|aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)|11/1/2005 - 10/31/2007||||participants|||Number
2772471|NCT00723073|Secondary|Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)|median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
2772472|NCT00723073|Primary|Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy|Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy|11/1/2005 - 10/31/2007||||participants|||Number
2772473|NCT00723073|Primary|Absence of Any Breakthrough Invasive Fungal Disease (IFD)|a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed > 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin|11/1/2005 - 10/31/2007||||participants|||Number
2772474|NCT00723073|Primary|Mortality at Hospital Discharge|We assessed all patients in the study cohort who dischaged from the hospital alive|11/1/2005 - 10/31/2007||||participants|||Number
2772475|NCT00723073|Primary|Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)|Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia|11/1/2005 - 10/31/2007||||participants|||Number
2772476|NCT00723073|Primary|Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)|Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.|11/1/2005 - 10/31/2007||||participants|||Number
2772477|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]|AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).|14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.||||||
2772478|NCT00723021|Other Pre-specified|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.||||||
2772479|NCT00723021|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.||||hrs||Full Range|Median
2772480|NCT00723021|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
2772481|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.|||ng*h/mL||Standard Deviation|Mean
2772482|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
2772483|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L/Sec||Standard Deviation|Mean
2772484|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline,24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
2772485|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
2772486|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
2772487|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
2772488|NCT00723008|Primary|Mean General Sleep Disturbance Scale (GSDS) Score|The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.|Baseline, Week 4, Week 8|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Score||Standard Deviation|Mean
2772489|NCT00723008|Primary|Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval|||VAS-A Score||Standard Deviation|Mean
2772490|NCT00723008|Primary|Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||VAS-P Score||Standard Deviation|Mean
2772491|NCT00723008|Primary|Mean Brief Profile of Mood States (BPOMS) Score|BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.|Baseline, Week 4, Week 8|One A:Active/Unblinded subject was removed from analysis due to a 39-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Brief POMS Score||Standard Deviation|Mean
2772492|NCT00723008|Primary|Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score|This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.|Baseline, 4 Weeks, 8 Weeks|One A:Active/Unblinded subject was removed from analysis due to a 31-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Score||Standard Deviation|Mean
2772493|NCT00723008|Primary|Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score|Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score >31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.|Baseline, Week 4, Week 8|All active subjects|||Score||Standard Deviation|Mean
2772494|NCT00722865|Secondary|Safety|Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years||||Participants|||Count of Participants
2772497|NCT00722865|Secondary|Overall Response Rate Using the Modified Cheson Criteria|Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT|2 years||||percentage of participants||90% Confidence Interval|Number
2772498|NCT00722865|Primary|Failure-free Survival|Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy|2 years and median follow-up of 18 months||||percentage of participants||90% Confidence Interval|Number
2772499|NCT00722800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|6 months||||points||Standard Deviation|Mean
2772500|NCT00722800|Secondary|Change From Baseline in VAS Pain Scale at Month 6.|"For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated no pain and a score of 10 indicated worst pain. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|6 months from Baseline||||units on a scale||Standard Deviation|Mean
2772501|NCT00722800|Primary|Mean Improvement in the Sartorius Severity Score at Month 6.|The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|6 months||||units on a scale||Standard Deviation|Mean
2772502|NCT00722761|Secondary|Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination|Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.|24 weeks|Intention to treat analysis. Participants with at least one follow up visit were included in the analysis. Last observation carried forward was used to fill up missing values/|||percentage of participants|||Number
2772503|NCT00722761|Primary|Percent Change in Truncal Lesion Counts|Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.|0-24 weeks|Intention to treat analysis. Only participants with at least one follow up were included in the analysis. Last observation carried forward was used to fill up missing data.|||percentage change of lesions||Standard Deviation|Mean
2772504|NCT00722722|Primary|Response to Bortezomib Monotherapy|Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.|6 months|In the 32 dose group, one patient received a kidney transplant with a B-cell flow cytometric crossmatch channel shift of less than 300 after dose 20 and was transplanted with a positive crossmatch donor. This patient was then excluded from further DSA analysis.|||participants|||Number
2772505|NCT00722566|Secondary|Number of Patients With Complete Response|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks."|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.|||Participants|||Number
2772506|NCT00722566|Primary|Number of Patients With Overall Response (Complete Response + Partial Response)|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.~Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg"|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.|||Participants|||Number
2772507|NCT00722553|Secondary|Overall Survival (OS)|The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.|Analysis per protocol. Patients who had not died or were lost to follow-up were censored|||Months||95% Confidence Interval|Median
2772598|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772508|NCT00722553|Secondary|Progression Free Survival (PFS)|Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.|||Months||95% Confidence Interval|Median
2772509|NCT00722553|Secondary|Clinical Benefit Rate (CBR)|The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)|Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.||||participants|||Number
2772510|NCT00722553|Secondary|Duration of Response (DOR)|Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.|Measured from the first day of documented response for up to 2 years after enrollment.|Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)|||Days||95% Confidence Interval|Median
2772511|NCT00722553|Primary|Objective Response Rate (ORR)|The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.||||participants|||Number
2772512|NCT00722436|Secondary|Platelets||baseline, after osteotomies, immediately after surgery||||10^9 platelets/L||Standard Deviation|Mean
2772513|NCT00722436|Secondary|Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).||(baseline, after osteotomies, and immediately after procedure)||||seconds||Standard Deviation|Mean
2772514|NCT00722436|Primary|Number of Patients That Remained Transfusion Free||24 hours||||participants|||Number
2772515|NCT00722436|Primary|Total Volume (ml/kg) of Allogeneic Blood Exposure.|This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.|intraoperative and postoperative (24 hr)||||ml/kg||Standard Deviation|Mean
2772516|NCT00722423|Secondary|Antiviral Treatment Rate|Number of patients started antiviral treatment|12-24 weeks post-treatment||||percentage of participants|||Number
2772517|NCT00722423|Primary|Sustained Virologic Response Rates|Virus not detected by PCR assay|12-24 weeks post-treatment||||participants|||Number
2772518|NCT00722371|Secondary|Change From Baseline in 2-Hour PMG at Week 54|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2772519|NCT00722371|Secondary|Change From Baseline in FPG at Week 54||Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2772520|NCT00722371|Primary|Change From Baseline in A1C at Week 54|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2772521|NCT00722371|Secondary|Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2772522|NCT00722371|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24||Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2772523|NCT00722371|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2772524|NCT00722137|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.|Up to 107.4 months|The safety population was defined as all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2772525|NCT00722137|Secondary|Overall Survival (OS) in Long Term Follow-up Period|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Up to 107.4 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
2772526|NCT00722137|Secondary|18-Month Survival|18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).|Up to month 18 from the time of randomization|The population consisted of all randomized participants.|||Percentage of Participants||95% Confidence Interval|Mean
2772527|NCT00722137|Secondary|Overall Survival (OS)|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
2772528|NCT00722137|Secondary|Overall Complete Response (CR + CRu)|Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Participants|||Number
2772529|NCT00722137|Secondary|Overall Response Rate (ORR)|ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Participants|||Number
2772530|NCT00722137|Secondary|Treatment-free Interval (TFI)|The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.|Median duration of follow-up of 40 months|All randomized participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2772531|NCT00722137|Secondary|Time to Next Anti-lymphoma Treatment (TTNT)|The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.|: Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
2772532|NCT00722137|Secondary|Duration of Response|The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Days||95% Confidence Interval|Median
2772533|NCT00722137|Secondary|Time to Progression (TTP)|Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
2772534|NCT00722137|Primary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
2772535|NCT00722124|Primary|7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)|7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)|8 weeks|Analysis was performed using intention to treat(ITT). Subjects who discontinued study participation were assumed to be smoking.|||participants|||Number
2772536|NCT00722111|Primary|Maximum Isometric Tongue Pressure|Peak isometric pressure at 4 sensors|16 months|PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available.Data was only available for two arms. All efforts were made to retrieve data.|||kPa||Full Range|Mean
2772537|NCT00722111|Primary|Isometric Lingual Pressure|Tongue Strength|8 weeks|PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available. Data was only available for one arm. All efforts were made to retrieve data.|||kPa||Full Range|Mean
2772538|NCT00722072|Secondary|Overall Survival||28 to 56 days after discontinuation of study therapy|Long term survival data was not collected due to early study termination||||||
2772539|NCT00722072|Secondary|Progression-free Survival||Start of treatment to time of progression or death, whichever comes first.|Long term survival data was not collected due to early study termination||||||
2772540|NCT00722072|Secondary|Time to Progression||Start of treatment to time of progression.|Progression data was not collected due to early study termination.||||||
2772541|NCT00722072|Secondary|Objective Response Rate||Every 8 weeks (two cycles) while receiving study therapy.|Response assessment data was not collected past 4 months due to early study termination.||||||
2772542|NCT00722072|Primary|Number of Participants With Progression-free Survival at 4 Months|Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).|4 months after initiating treatment with sorafenib plus fulvestrant.||||Participants|||Number
2772543|NCT00722020|Secondary|Secondary Endpoint Total Hospital Length of Stay|Seconadary endpoint was Total Hospital length of stay|30 Days||||days||Standard Deviation|Mean
2772545|NCT00722007|Secondary|The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively|"The following was assessed:~Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration > 4mm; Medial/Lateral Migration > 4mm; Varus/Valgus Tilt > 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component > 4mm and Stem tilting > 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis"|Month 24+||||Implants|Implants||Count of Units
2772546|NCT00722007|Secondary|Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events||Month 24+||||Implants|Implants||Count of Units
2772547|NCT00722007|Secondary|Survival Rate Using Kaplan-Meier Survival Curves|Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24|Month 24+||||Implants|Implants||Count of Units
2772548|NCT00722007|Secondary|Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+|"All unilateral and bilateral implants have been assessed using the following grading:~Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=<39); Moderate Dysfunction (20=<29); Severe Dysfunction (10=<19); Disabled (0=<9)"|Month 24+||||Implants|Implants||Count of Units
2772549|NCT00722007|Primary|The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24|"Composite Clinical Success (CCS) is based upon the following:~There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points."|Month 24+||||Implants|Implants||Number
2772550|NCT00721968|Other Pre-specified|Number of Ocular Hypotensive Medications by Visit||12 months||||medications||Standard Deviation|Mean
2772551|NCT00721968|Primary|Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications|Percent reaching this endpoint|12 months|Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications|||participants|||Number
2772552|NCT00721955|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF|||Participants|||Count of Participants
2772553|NCT00721955|Secondary|Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
2772554|NCT00721955|Primary|Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo|The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
2772555|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change||Standard Deviation|Mean
2772556|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-Patlak||Standard Deviation|Mean
2772557|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-FLT||Standard Deviation|Mean
2772558|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmax||Standard Deviation|Mean
2772559|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmean||Standard Deviation|Mean
2772560|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772729|NCT00721188|Primary|Maximum Observed Serum Concentration (Cmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug/dL||Standard Deviation|Mean
2772561|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan|||l/min||Standard Deviation|Mean
2772562|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
2772563|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772564|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772565|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772566|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan|||l/min||Standard Deviation|Mean
2772567|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
2772568|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mm^3 (cubic milimeters)||Standard Deviation|Mean
2772569|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772570|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772571|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change||Standard Deviation|Mean
2772572|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-Patlak||Standard Deviation|Mean
2772573|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-FLT||Standard Deviation|Mean
2772574|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmax||Standard Deviation|Mean
2772575|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmean||Standard Deviation|Mean
2772576|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772577|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan|||l/min||Standard Deviation|Mean
2772578|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
2772579|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772580|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772581|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772582|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan|||l/min||Standard Deviation|Mean
2772583|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
2772599|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772584|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mm^3 (cubic milimeters)||Standard Deviation|Mean
2772585|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772586|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
2772587|NCT00721734|Secondary|Time to Progression (TTP)|Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods.|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population|||months||95% Confidence Interval|Median
2772588|NCT00721734|Secondary|Duration of Response|"Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death.~Progressive disease was defined as any of the following:~An increase of more than 25% from nadir in any one of the following:~M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL);~Urine (the absolute increase had to be ≥ 200 mg/24 hours);~The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be > 10 mg/dL);~≥ 10% bone marrow infiltration by plasma cells;~Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas.~Median duration of response was estimated using the Kaplan-Meier method."|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.|||months||95% Confidence Interval|Median
2772589|NCT00721734|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks.|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population|||percentage of participants||95% Confidence Interval|Number
2772590|NCT00721734|Secondary|Overall Response Rate (ORR)|"ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma.~sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline."|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment.|||percentage of participants||95% Confidence Interval|Number
2772591|NCT00721734|Secondary|Plasma Protein Binding (PPB) of Carfilzomib|The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15).|End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15|Participants with available data|||percentage of carfilzomib bound||Standard Deviation|Mean
2772592|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
2772593|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
2772594|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
2772595|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
2772596|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772600|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772601|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772602|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772603|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772604|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772605|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data|||liters/hour||Standard Deviation|Mean
2772606|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data|||liters/hour||Standard Deviation|Mean
2772607|NCT00721734|Primary|Clearance (CL) of Carfilzomib on Day 1 of Cycle 1|Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.|Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|"The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1–4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included.~CL could not be estimated for 11 patients in the PK population."|||liters/hour||Standard Deviation|Mean
2772608|NCT00721630|Secondary|Number of Participants With Toxicities Associated With Capecitabine and Lapatinib|Toxicities evaluated according to NCI CTC v.3|6 months||||Participants|||Count of Participants
2772609|NCT00721630|Primary|Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|6 months||||Participants|||Count of Participants
2772610|NCT00721617|Secondary|C-peptides Levels for Intralipid/Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
2772611|NCT00721617|Secondary|C-peptides Levels for Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
2772612|NCT00721617|Secondary|C-peptides Levels for Intralipid Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
2772613|NCT00721617|Secondary|C-peptides Levels for Saline Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
2772614|NCT00721617|Secondary|Insulin Levels for Intralipid/Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
2772615|NCT00721617|Secondary|Insulin Levels for Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
2772616|NCT00721617|Secondary|Insulin Levels for Intralipid Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
2772617|NCT00721617|Secondary|Insulin Levels for Saline Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
2772618|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid/Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
2772619|NCT00721617|Secondary|Plasma Glucose Levels for Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
2772620|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 8 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 8 hours||||mmHg||Standard Deviation|Mean
2772621|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 4 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 4 hours||||mmHg||Standard Deviation|Mean
2772622|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
2772623|NCT00721617|Secondary|Plasma Glucose Levels for Saline Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
2772624|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 8 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.|Baseline, 8 hours||||mg/dL||Standard Deviation|Mean
2772625|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 4 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.|Baseline, 4 hours||||mg/dL||Standard Error|Mean
2772626|NCT00721617|Secondary|Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.|Baseline, 8 hours||||mmol/L||Standard Deviation|Mean
2772627|NCT00721617|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.|Baseline, 4 hours||||mmol/L||Standard Deviation|Mean
2772628|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 8 Hours|Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 8 hours||||mmHg||Standard Error|Mean
2772629|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 4 Hours|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 4 hours||||mmHg||Standard Error|Mean
2772630|NCT00721617|Primary|Change in Flow-mediated Dilation From Baseline to 4 Hours|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.|Baseline, 4 hours||||percent change in diameter||Standard Deviation|Mean
2772631|NCT00721578|Secondary|Medication Administration|Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration.|Up to 9 months|FAS.|||Participants|||Number
2772632|NCT00721578|Secondary|Median Duration of Antifungal Therapy||Up to 9 months|FAS.|||Days||Full Range|Median
2772633|NCT00721578|Secondary|Concomitant Medications||Up to 9 months|FAS.|||Participants|||Number
2772634|NCT00721578|Primary|Number of Participants With Mycological Outcomes|"Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy~), or unknown (results are not available/not known) as assessed by the Investigator/Physician."|Up to 9 months|FAS.|||Participants|||Number
2772635|NCT00721578|Primary|Number of Participants With Clinical Outcomes.|"Clinical outcomes, as assessed by the investigator, defined as:~Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period.~Deteriorated: clinical signs and symptoms of fungal infection worsened (including death).~Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation."|Up to 9 months|FAS.|||Participants|||Number
2772636|NCT00721578|Primary|Total Daily Dose for Selected Antifungal Agent||Up to 9 months|FAS. Data were not analyzed.|||mg|||Number
2772637|NCT00721578|Primary|Management of SFI: Reason for Selection of Antifungal Agent|Number of participants with reason for investigator's selection of particular antifungal therapy.|Up to 9 months|FAS. Data were not analyzed.|||Participants|||Number
2772638|NCT00721578|Primary|Management of SFI: Choice of Treatment|Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.|Up to 9 months|FAS.|||Participants|||Number
2772639|NCT00721578|Primary|Diagnosis of Systemic Fungal Infection (SFI)|Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.|Up to 9 months|Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment|||Participants|||Number
2772640|NCT00721539|Secondary|Average Operative Time|Average operative time in minutes|Up to four hours (240 minutes)|Participants|||Minutes||Full Range|Mean
2772641|NCT00721539|Secondary|Average Blood Loss|Blood lost during procedure|Duration of procedure up to two hours|Participants|||mL||Full Range|Mean
2772642|NCT00721539|Secondary|Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure||Six weeks|Adult patients 18 years of age and over|||Participants|||Number
2772643|NCT00721539|Primary|Overall Complication Rate (Intraoperative and Postoperative)|Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.|Six weeks|Subjects enrolled in this pilot study.|||Participants|||Number
2772730|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.|at 2 weeks and 4 weeks after stent insertion|91 participants who had successful stent insertion were analyzed based on per protocol analysis.|||proportion of participants||95% Confidence Interval|Mean
2772644|NCT00721513|Secondary|MD Anderson Dysphagia Inventory|The MD Anderson Dysphasia Inventory (MDADI) is a survey specifically designed to assess dysphasia. It contains 20 questions directly addressing the swallowing function and several other general questions. The questionnaire asks for participants views about their swallowing ability at baseline, pre-radiation therapy and post-radiation therapy. All questions except for E7 and F2: Strongly Agree = 1 point, Agree = 2 points, No Opinion = 3 points, Disagree = 4 points, Strongly Disagree. E7 and F2: Strongly agree = 5 points, Agree = 4 points, no opinion = 3 points, disagree = 2 points, strongly disagree = 1 point. Scores range from 20 (extremely low‐functioning) to 100 (high‐functioning).|Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years|Data was not collected on all participants|||Score on a scale||Standard Deviation|Mean
2772645|NCT00721513|Secondary|Performance Status Scale for Head and Neck Cancer|Consists of assessment of three functions (subscales): Normalcy of diet, eating in public, and understandability of speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores range from 0-100 (Full performance (100 score), moderate or severe impairment (≤ 50 score)). The higher the score, the better the ability of the patient to function.|Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years|Data was not collected for all participants.|||Score on a scale||Standard Deviation|Mean
2772646|NCT00721513|Secondary|Number of Participants With Local-Regional Control||up to 2 years||||Participants|||Count of Participants
2772647|NCT00721513|Secondary|Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)|"Four subscales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). Items are rated on a five-point scale: 0-not at all, 1- a little bit, 2-somewhat, 3- quite a bit and 4-very much. Overall quality of life is the sum of the core items of the FACT-G possible range of 0-108 points. The higher the score the better the quality life. This interval includes 0, we will conclude that there is not conclusive statistical evidence that there is an improvement or worsening. If the interval does not include 0 we can determine whether there was a significant improvement (or worsening) depending on which side of the 0 the interval is on. The total outcome index score (possible range 0-108 points) is the sum of the physical and functional well being and additional concerns categories from the FACT-G."|Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years|This data was not collected on all participants.|||Score on a scale||95% Confidence Interval|Mean
2772648|NCT00721513|Secondary|Number of Participants With Distant Metastasis||up to 2 years||||Participants|||Count of Participants
2772649|NCT00721513|Secondary|Overall Survival||up to 2 years||||months||Standard Error|Median
2772650|NCT00721513|Secondary|Best Overall Response Rate|Defined as rate of complete and partial responses (at least 30% decrease in the sum of the longest diameter of target lesions), measured by CT scan or MRI of the head and neck after completion of multimodality treatment with induction TPF (Docetaxel, cisplatin and fluorouracil) chemotherapy followed by combined ERT. We will use RECIST (Response Evaluation Criteria In Solid Tumors) (Therasse et al, 2000) for evaluation of response.|up to 2 years||||Participants|||Count of Participants
2772651|NCT00721513|Secondary|Objective Response Rate|Will be measured by CT scan /MRI of the head and neck with corroborative results of direct biopsy of any residual tumor at primary site.|up to 2 years||||Participants|||Count of Participants
2772652|NCT00721513|Primary|Progression-free Survival||up to 2 years||||months||Standard Error|Median
2772653|NCT00721500|Primary|Lens Tightness on Cornea With Manual Digit Push Up|Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||percentage|Participants|Standard Deviation|Mean
2772654|NCT00721500|Primary|Lens Fit Decentration|Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||mm|Participants|Standard Deviation|Mean
2772655|NCT00721500|Primary|Proportion of Eyes Successfully Fit|Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||proportion of participant eyes|Participants||Number
2772656|NCT00721409|Secondary|Number of Participants With Treatment-Related Adverse Events at Phase 2|AE: any untoward medical occurrence in a participant who received study drug. AEs included both serious and non-serious adverse events. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs: events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Treatment related AEs: all AEs with causality related to treatment. Relatedness to drug was assessed by the investigator. AEs were graded according to the CTCAE version 3.0 and coded using the MedDRA. Number of participants with AE of grade 3 or 4 and with AE of grade 5 were reported as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE.|Baseline up to 28 days after last dose of study drug (for a maximum of 86 months)|All treated as treated set included all treated participants classified by the treatment actually received.|||Participants|||Count of Participants
2772666|NCT00721409|Secondary|Number of Participants With CBR at Phase 2 - Investigator Assessment|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized patients from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Percentage of participants||95% Confidence Interval|Number
2772657|NCT00721409|Secondary|Number of Participants With TEAEs (All Causalities) at Phase 2|AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.AEs included both serious and non-serious AEs.SAE:AE resulting in any of following outcomes/deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience (immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly.Treatment emergent AEs:events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or worsened relative to pre-treatment state.AEs were graded as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and coded using Medical Dictionary for Regulatory Activities (MedDRA). Participants with AE of grade 3 or 4 and grade 5 were reported as Grade 3:Severe, Grade 4:Life threatening, Grade 5:Death related to AE.|Baseline up to 28 days after last dose of study drug (for a maximum of 86 months)|All treated as treated set included all treated participants classified by the treatment actually received.|||Participants|||Count of Participants
2772658|NCT00721409|Secondary|Percentage of Participants With Tumor Expression of CYP19A1 and CCND1 Genotypes at Phase 2|One 2-mL blood specimen was collected for the analysis of germline polymorphism in CYP19A1 and CCND1 genes. A single nucleotide polymorphism (SNP) rs4646 as defined in the National Center for Biotechnology Information (NCBI) database in the aromatase gene (CYP19A1) was analyzed. A germline polymorphism G/A870 (rs9344) in the CCND1 gene was analyzed.|Screening visit (≤ 28 Days prior to dosing)|Polymorphism analysis set included participants in the safety analysis set who had at least 1 polymorphism assessment.|||Percentage of participants|||Number
2772659|NCT00721409|Secondary|Summary of Copy Number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) at Phase 2|Gene copy number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) were evaluated. This analysis was done for Phase 2 combined group.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.|||Copy number||Standard Deviation|Mean
2772660|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Tumor Retinoblastoma (RB) and CyclinD1|Presence or absence of tumor RB and CyclinD1 were evaluated. The following definitions of expression applied in the below table: Positive: any expression >0 and Negative: any expression=0.|Screening visit (≤ 28 Days prior to dosing)|Protein biomarkers analysis set included all participants in the safety analysis set who had at least protein biomarker assessment.|||Participants|||Number
2772661|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Ki67|Frequency of tumor tissue biomarker Ki67 was evaluated in across treatment groups.|Screening visit (≤ 28 Days prior to dosing)|All participants in the Safety Analysis set who had a Ki67 protein biomarker assessment.|||Participants|||Number
2772662|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - p16/INK4A, CCND1|Tissue samples were used for retrospective biomarker analyses. For Phase 2 Part 2, the tissue samples were sent to a central laboratory for the assessment of participant selection biomarkers. For Phase 2 Part 1, the assessment of the biomarkers (CCND1 amplification and/or loss of p16) were performed retrospectively from the available samples.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.|||Participants|||Number
2772663|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Interference Scale (mBPI-sf) Questionnaire at Phase 2|"The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (no pain or does not interfere) to 10 (pain as bad as you can imagine or completely interferes)."|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.|||Units on a scale||Standard Error|Mean
2772664|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Severity Scale (mBPI-sf) Questionnaire at Phase 2|"The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (no pain or does not interfere) to 10 (pain as bad as you can imagine or completely interferes)."|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.|||Units on a scale||Standard Error|Mean
2772665|NCT00721409|Secondary|Time to Tumor Progression (TTP) at Phase 2-Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
2772707|NCT00721227|Secondary|Weight Loss Following Reduction Gastroplasty|Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.|12 months|Includes only participants who completed month 12 visit.|||Percentage of weight loss||Standard Deviation|Mean
2772667|NCT00721409|Secondary|Duration of Response at Phase 2 - Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|A subset of ITT population i.e., participants who had response was used for this analysis.|||Months||95% Confidence Interval|Median
2772668|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response in Participants With Measurable Disease at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Measurable disease referred to the lesions that was accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10-16 mm with spiral computer tomography scan (depending on reconstruction interval). Clinical lesions were only be considered measurable when they were superficial (eg, skin nodules, palpable lymph nodes).|From randomization up to the end of treatment (approximately 41 months)|Participants in ITT population with measurable disease were used.|||Percentage of participants||95% Confidence Interval|Number
2772669|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Percentage of participants||95% Confidence Interval|Number
2772670|NCT00721409|Secondary|Overall Survival (OS) at Phase 2|Time in weeks or months from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7 or 30.44 if in months.|From randomization until death (assessed up to 86 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
2772671|NCT00721409|Secondary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval at Phase 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|Cycle 1 Day 1 prior to dosing, Cycle 1 Day 14 (2, 4 [prior to meal], 8, 24, 48, and 96 hours after dosing of Palbociclib), Cycle 2 Day 1 and Day 14 (prior to and 4 hours after dosing of letrozole)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
2772672|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Tmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Full Range|Median
2772673|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Cmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772674|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: AUC24 at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2772675|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Volume of Distribution (Vz/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||L||Geometric Coefficient of Variation|Geometric Mean
2772676|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Clearance (CL/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2772677|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Terminal Plasma Half-life (t1/2) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Standard Deviation|Mean
2772678|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Time to Maximum Plasma Concentration (Tmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Full Range|Median
2772679|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Maximum Observed Plasma Concentration (Cmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2772680|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2772681|NCT00721409|Secondary|Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1|CBR is defined as a confirmed CR, confirmed PR, or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 weeks after initial response.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.|||Percentage of participants||95% Confidence Interval|Number
2772682|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Tumor Response at Phase 1|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.|||Percentage of participants||95% Confidence Interval|Number
2772708|NCT00721227|Secondary|Durability of Gastric Plications Following Reduction Gastroplasty|The number of participants who completed month 12 gastroscopies showing intact plications.|12 month|Includes only participants who completed month 12 gastroscopy.|||participants|||Number
2772683|NCT00721409|Primary|Progression-Free Survival (PFS) at Phase 2 - Investigator Assessment|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Weeks or Months) = (first event date minus randomization or the first dose date plus 1) divided by 7 (or 30.44 if in months). PFS is usually characterized by the median, 25% percentile,75% percentile and their 95% Confidence Intervals (CIs).|From randomization date to date of first documentation of progression or death (assessed up to 41 months)|Intent-to-Treat (ITT) was used. This represented all randomized participants from Ph2P1 or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
2772684|NCT00721409|Primary|Number of Participants With Dose Limiting Toxicities at Phase 1|Dose limiting toxicity was defined as any of the following TEAEs occurring during the second cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment-related toxicities (platelet count <50,000/μL; ANC <1,000/μL; nonhematologic toxicities of Grade ≥3 severity). 5. Inability to deliver at least 80% of the planned Palbociclib or letrozole doses during Cycle 2 due to toxicity possibly attributable to the study treatment.|Cycle 2 (4 weeks)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
2772685|NCT00721409|Primary|Number of Participants With Treatment-Related Adverse Events at Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
2772686|NCT00721409|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
2772687|NCT00721396|Secondary|Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.|"Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.~Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies."|1 month after 3rd vaccination||||Percentages of subjects||95% Confidence Interval|Number
2772688|NCT00721396|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|One month after third Men B vaccination|PP Population|||Percentages of subjects||95% Confidence Interval|Number
2772689|NCT00721396|Secondary|Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.|The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.|One month after third Men B vaccination|PP Population|||Percentages of subjects||95% Confidence Interval|Number
2772690|NCT00721396|Secondary|Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|one month after third Men B vaccination|PP Population|||Ratio||95% Confidence Interval|Geometric Mean
2772691|NCT00721396|Secondary|Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.|One month after third Men B vaccination|PP Population|||Titers||95% Confidence Interval|Geometric Mean
2772692|NCT00721396|Secondary|Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine|Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.|One month after 3rd vaccination|All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population.|||Percentages of subjects||95% Confidence Interval|Number
2772693|NCT00721396|Secondary|Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age|The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.|One month after 3rd Men B vaccination|Analysis was done on the per-protocol population i.e all subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2772694|NCT00721396|Primary|Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age|Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).|10 months (groups 1 and 2); 8 months (groups 3 and 4)|All subjects receiving at least one injection and providing post-baseline safety data (Safety Set).|||Number of subjects|||Number
2772695|NCT00721396|Primary|Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine|"The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).~The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains."|One month after third Men B vaccination|The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline.|||Percentages of subjects||95% Confidence Interval|Number
2772696|NCT00721357|Secondary|Magnetic Resonance Spectroscopy of Muscle Metabolic Properties|time constant indicating the time for recovery in muscle phosphocreatine levels following exercise as a metric of muscle oxidative capacity.|within one week of enrollment|Sample size differences reflect the fact that some subjects are either incompatible with imaging procedures because they are either unable to lie still for the time necessary to collect these data, are claustrophobic or have metal somewhere in their body that prevents imaging.|||seconds||Standard Deviation|Mean
2772697|NCT00721357|Secondary|Muscle Mechanical Energy Expenditure|mechanical work done by lower extremity joints|one time measure within one week of enrollment|Individuals following stroke and matched non-stroke individuals. Sample size differences reflect the inability of some subjects to walk on the instrumented treadmill at speeds necessary to collect the kinematic data.|||joules per kilogram meter||Standard Deviation|Mean
2772698|NCT00721357|Primary|Oxygen Consumption During Walking|Amount of oxygen consumed during walking at self-selected speed normalized to speed|within one week of enrollment||||ml/kg/min||Standard Deviation|Mean
2772699|NCT00721279|Primary|Correlation of the Change in IRLS at End of Titration and at Final Visit|Correlation of the change in IRLS at end of titration and at final visit|Up to 12 weeks|Full Analysis Set (FAS)|||percentage of patients|||Number
2772700|NCT00721279|Primary|Frequency of Adverse Events|Frequency of patients with any adverse event, causally related adverse events and serious adverse events|Up to 16 weeks|Safety Analysis Set (SAF)|||participants|||Number
2772701|NCT00721279|Primary|Change in Global Clinical Impression - Improvement (CGI-I) Scale|The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse|baseline and final visit (week 12)|Full analysis set|||percentage of participants|||Number
2772702|NCT00721279|Primary|Change in Total Scores of IRLS (International Restless Legs Rating Scale)|"The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.~The change from baseline was calculated as baseline minus the week 12 value."|Baseline and final visit (week12)|Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included|||scores on a scale||Inter-Quartile Range|Median
2772703|NCT00721279|Primary|Frequency Analysis for Baseline Pattern of RLS Symptoms|Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.|Baseline|Full analysis set (FAS)|||percentage of participants|||Number
2772704|NCT00721253|Secondary|Defocus Curve|"Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|6 months post-operative||||logMAR||Standard Deviation|Mean
2772705|NCT00721253|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 months||||log units||Standard Deviation|Mean
2772706|NCT00721253|Primary|Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate|"Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity."|6 months||||logMAR||Standard Deviation|Mean
2772710|NCT00721214|Secondary|Two-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with two year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two- year event-free survival rate is the same as for overall survival, 37% (SE = 14.3%).|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
2772711|NCT00721214|Secondary|One-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with one year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated one-year event-free survival rate is the same as for overall survival, 47% (SE = 13.6%).|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
2772712|NCT00721214|Secondary|Two-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts.|Percentage of participants alive two years after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two year survival rate is 37% .The estimated two-year overall survival rate is the same as two-year event free survival.|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
2772713|NCT00721214|Primary|Two Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival. The percentage of patients was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated two-year event-free survival rate is the same as overall survival, 50%.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
2772714|NCT00721214|Primary|One Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival, as estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated one-year event-free survival rate is the same as overall survival, 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
2772715|NCT00721214|Primary|Two Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive two years after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated two year survival rate is 50%, the same as one year survival rate.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
2772716|NCT00721214|Secondary|One-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants alive one year after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored. The estimated one year overall survival rate from this curve is 47%. The one year overall survival is the same as one year event free survival rate.|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
2772717|NCT00721214|Primary|One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive one year after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated one year survival rate from this curve is 50%, while the estimated two year survival rate is 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
2772718|NCT00721188|Secondary|Number of Participants With Serious Adverse Events (SAE's)||Day of initial treatment with Venofer through 30 days after study treatment||||participants|||Number
2772719|NCT00721188|Secondary|Mean Residence Time (MRtime)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
2772720|NCT00721188|Secondary|Volume of Distribution at Steady State (Vdss)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
2772731|NCT00721175|Secondary|Cost Effective Ratio of Metallic and Plastic Stent|cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature|until the patients expire (Markov model)|Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma|||cost (US$) per QALY|||Number
2772732|NCT00721175|Secondary|Patients Survival Times|survival times of the patients after the first stent insertion|until patient died or 6 months after the last patient was enrolled||||days||Inter-Quartile Range|Median
2772733|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.|at 2 weeks and 4 weeks after stent insertion|All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)|||proportion of participants||95% Confidence Interval|Mean
2772734|NCT00721162|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 30 months|All participants who received any amount of study drug.|||participants|||Number
2772735|NCT00721162|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 43.9 months|All participants who received any amount of study drug. The number of participants censored was 12.|||months||95% Confidence Interval|Median
2772736|NCT00721162|Secondary|Overall Survival at 1 Year (OS-1)|Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.|First dose to 12 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2772737|NCT00721162|Secondary|Progression-Free Survival (PFS)|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 34.6 months|All participants who received any amount of study drug. The number of participants censored was 11.|||months||95% Confidence Interval|Median
2772738|NCT00721162|Primary|Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)|Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2772739|NCT00721162|Primary|Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)|Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.|First Dose to 6 Months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2772740|NCT00721149|Secondary|Percentage of Subjects Who Responded to Quality of Life Assessment|SF 36 Symptom Frequency and Severity Checklist|1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
2772741|NCT00721149|Secondary|TTM Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
2772742|NCT00721149|Secondary|24-hour Holter Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
2772743|NCT00721149|Secondary|Percentage of Subjects Who Achieved Acute Success|Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.|Day 91 - 361|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
2772744|NCT00721149|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.|within 7 days of ablation procedure|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
2773166|NCT00718315|Primary|Percentage of Participants With Skin Rash Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death|30 Days|ITT Population|||percentage of participants|||Number
2772745|NCT00721149|Primary|Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.|A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).|From study day 91 through day 361|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
2772746|NCT00721136|Primary|Anticoagulant Related Complications|Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia|30 days||||participants|||Number
2772747|NCT00721136|Primary|Thromboembolic Events||30 days||||participants|||Number
2772748|NCT00721136|Primary|Bleeding Complication|Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.|30 days|Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024).|||participants|||Number
2772749|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks|The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Percentage of Participants|||Number
2772750|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks|"Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis.~FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Percentage of Participants|||Number
2772751|NCT00721123|Primary|Overall Death Rate Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1.~To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure."|through 264 Weeks|All exposure population, which included all participants who entered the study and received at least one dose of tocilizumab at any time.|||Deaths per 100 PY||95% Confidence Interval|Number
2772752|NCT00721123|Primary|Summary Adverse Event Rates Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied.~Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed unrelated to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity.~Medical confirmation of the AESI GI perforation was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Adverse Events per 100 Patient Years||95% Confidence Interval|Number
2772753|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks|"The patient's assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as no pain and the extreme right end as unbearable pain. Change from baseline was calculated for given periods, and a negative change indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
2772754|NCT00721123|Secondary|Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks|"Physician's global assessment of disease activity is the treating physician's assessment of the patient's current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as no disease activity (symptom-free and no arthritis symptoms) and the extreme right end as maximum disease activity. Change from baseline was calculated for given periods, and a negative change indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
2772808|NCT00720629|Secondary|Incidence of Rituximab Response to Reactivated EBV Without PTLD|"Participants who developed plasma EBV-DNA of >1000 copies/mL on any tests received rituximab.~Incidence of Rituximab Response: Reactivated EBV participants whose plasma titers cleared after rituximab, without post-transplant lymphoproliferative disorder (PTLD)."|100 days|Reactivated EBV participants|||participants|||Number
2772755|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks|"Patient's global assessment of disease activity is the patient's overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme as maximum disease activity (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
2772756|NCT00721123|Secondary|Change From Baseline in Scores for Health Assessment Questionnaire − Disability Index Over Time, Through 264 Weeks|"The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.~To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
2772757|NCT00721123|Secondary|Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks|"Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement.~A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Joints||Standard Deviation|Mean
2772758|NCT00721123|Secondary|Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks|Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Percentage of Participants|||Number
2772759|NCT00721123|Secondary|Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks|The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Percentage of Participants|||Number
2772760|NCT00721123|Secondary|Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks|"The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.~Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms.~Scores on the ACR scale may be up to ACR100 because the number after ACR is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score - that percentage of improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab, with a score at the given time point.|||Percentage of Participants|||Number
2772761|NCT00721123|Primary|Adverse Event (AE) Summary Over Time|The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Participants|||Number
2772762|NCT00721110|Secondary|Verbal Response Fatigue Score on Postoperative Day 1|Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.|postoperative day 1|11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine).|||units on a scale||Standard Deviation|Mean
2772763|NCT00721110|Secondary|Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day||2 hours after surgery, on postoperative day 1||||percentage of participants|||Number
2772764|NCT00721110|Secondary|Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2||intraoperative through postoperative day 2||||milligram morphine sulfate equivalents||Inter-Quartile Range|Median
2772765|NCT00721110|Secondary|Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2|Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.|PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2||||units on a scale||Standard Deviation|Mean
2772766|NCT00721110|Primary|The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two|The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.|postoperative day 2||||meters||Standard Deviation|Mean
2772767|NCT00720941|Secondary|MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.|Weeks 4, 10, 16, and 22|ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.|||visits||Standard Deviation|Mean
2772768|NCT00720941|Secondary|Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24|Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.|From Day 1 up to Week 24|ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.|||events per 30 days||Standard Deviation|Mean
2772769|NCT00720941|Secondary|Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The CTSQ assesses 3 domains related to the participant's satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.|Weeks 4, 10, 16, and 22|ITT Population. Participants missing scores at early time points were excluded from the analysis at those time points. Mean total score was calculated at each assessment week.|||Scores on a scale||Standard Deviation|Mean
2772770|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
2772771|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
2772778|NCT00720941|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.|Baseline (predose); Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
2772772|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of  In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness? by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
2772773|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
2772774|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions (I am able to work, I am able to enjoy life, and I am content with the quality of my life now) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
2772775|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions (I have nausea, I have diarrhea, and I am bothered by side effects of treatment) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
2772776|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of I worry that my condition will get worse by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
2772777|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions (I have a lack of energy, I feel pain, for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
2772796|NCT00720798|Secondary|Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Joints||Standard Deviation|Mean
2772779|NCT00720941|Secondary|Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)|See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.|From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)|Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.|||Participants|||Number
2772780|NCT00720941|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)|ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.|||Months||95% Confidence Interval|Median
2772781|NCT00720941|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)|ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Weeks||95% Confidence Interval|Median
2772782|NCT00720941|Secondary|Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review|The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.|From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)|ITT Population|||Participants|||Number
2772783|NCT00720941|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death (up to Study Week 268)|ITT Population. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||Months||95% Confidence Interval|Median
2772784|NCT00720941|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.|From randomization until the earliest date of disease progression or death (up to Study Week 191)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||Months||95% Confidence Interval|Median
2772785|NCT00720876|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.|3 weeks after the stop of treatment||||Participants|||Count of Participants
2772786|NCT00720876|Secondary|Progression-free Survival|Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis. Estimated using the product-limit method of Kaplan and Meier.|Until disease progress\relapse, up to 1 year after the start of treatment||||Months||95% Confidence Interval|Median
2772787|NCT00720876|Primary|Overall Response Rate (Complete and Partial Response)|Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.|After every 3 cycles, up to 1 year after the start of treatment||||percentage of participants|||Number
2772788|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264|The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772789|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264|The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772790|NCT00720798|Secondary|Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772791|NCT00720798|Secondary|Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772792|NCT00720798|Secondary|Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2772793|NCT00720798|Secondary|Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Erythrocyte sedimentation rate (ESR) was determined locally.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||mm/h||Standard Deviation|Mean
2772794|NCT00720798|Secondary|Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2772795|NCT00720798|Secondary|Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264|"Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated no disease activity (symptom-free and no arthritis symptoms, score = 0) and the right end indicated maximum disease activity (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated no disease activity (symptom-free and no arthritis symptoms, score = 0) and the right end indicated maximum disease activity (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated no pain (score = 0) and the right end of the scale indicated unbearable pain (score = 100)."|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||mm||Standard Deviation|Mean
2772878|NCT00720330|Secondary|Time From the End of Surgery to Readiness for Hospital Discharge.||Until hospital discharge, assessed up to 6 months||||hours||Standard Deviation|Mean
2772797|NCT00720798|Secondary|Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264|"Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale no disease activity [symptom-free and no arthritis symptoms], right end of the scale maximum disease activity); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale no pain, right end of the scale unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate."|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772798|NCT00720798|Secondary|Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264|"A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale no disease activity [symptom-free and no arthritis symptoms], right end of the scale maximum disease activity); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale no pain, right end of the scale unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate."|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772799|NCT00720798|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264|"Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale no disease activity [symptom-free and no arthritis symptoms], right end of the scale maximum disease activity); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale no pain, right end of the scale unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate."|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
2772800|NCT00720798|Secondary|Percentage of Participants Who Changed From Monotherapy to Combination Therapy|Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.|Baseline to Week 296|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.|||Percentage of participants|||Number
2772801|NCT00720798|Secondary|Percentage of Participants With Concomitant Oral Corticosteroid Therapy|"Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.~The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months."|Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
2772802|NCT00720798|Secondary|Percentage of Participants Who Withdrew From Treatment||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
2772803|NCT00720798|Primary|Percentage of Participants With ≥ 1 Adverse Event||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
2772804|NCT00720759|Primary|Wolf Motor Function Test (Time)|The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.|3 months after completion of treatment||||units on a scale||Standard Deviation|Mean
2772805|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 2|Mean terminal half-life (±SD)|Up to 205 hours|All participants|||hours||Standard Deviation|Mean
2772806|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 1|Mean Cmax (±SD)|At 1 - 2 hours|All participants|||ng/mL||Standard Deviation|Mean
2772807|NCT00720629|Secondary|Overall Survival (OS)|Median OS in days. Survival was measured from the time of transplant to the time of death.|At 2 years and 5 years|Participants who had died by Year 2 and additional participants who had died by Year 5.|||days||Full Range|Median
2772809|NCT00720629|Secondary|Incidence of Epstein-Barr Virus (EBV) Reactivation|Number of participants who reactivated EBV. Patients had their plasma tested once weekly using the TaqMan polymerase chain reaction (PCR) for quantitative determination of EBV-DNA for 6 weeks. Plasma levels > 1000 copies per ml plasma were scored as positive.|3 months|All participants|||participants|||Number
2772810|NCT00720629|Primary|Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days|"Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned.~Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II"|100 days|All participants|||participants|||Number
2772811|NCT00720499|Secondary|AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)|"AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.~FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.~Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report."|4 weeks|No patients analyzed in the study report.||||||
2772812|NCT00720499|Secondary|12-lead ECG QT Intervals|"12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
2772813|NCT00720499|Secondary|12-lead ECG QTcB Intervals|"12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
2772814|NCT00720499|Secondary|12-lead ECG QTcF Intervals|"12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
2772815|NCT00720499|Secondary|12-lead ECG QRS Intervals|"12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
2772816|NCT00720499|Secondary|12-lead ECG PR Intervals|"12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
2772817|NCT00720499|Secondary|12-lead ECG Heart Rate|"12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM)~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||BPM||Standard Deviation|Mean
2772818|NCT00720499|Secondary|Overall Marked Changes From Baseline in Vital Signs|Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline to week 14|TS|||participants|||Number
2772819|NCT00720499|Secondary|Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination|Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination|14 weeks|Treated Set (TS) including all randomized patients who received at least one dose of study medication.|||participants|||Number
2772820|NCT00720499|Secondary|Physician's Global Evaluation|"Physician's global evaluation score on days 15 and 29~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8~The presented means are adjusted"|Days 15 and 29|FAS|||units on a scale||Standard Error|Mean
2772821|NCT00720499|Secondary|Patient Global Rating|"Patient global rating scores treatment comparison after 4 weeks~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse~The presented means are adjusted."|4 weeks|FAS|||units on a scale||Standard Error|Mean
2772822|NCT00720499|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])|"Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4.~The means presented are the adjusted mean of weekly mean."|Weeks 1,2,3 and 4|FAS|||number of occasions / day||Standard Error|Mean
2772823|NCT00720499|Secondary|Weekly Mean Evening PEFR|"Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS|||Litres / minute||Standard Error|Mean
2772824|NCT00720499|Secondary|Weekly Mean Morning PEFR|"Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS|||Litres / minute||Standard Error|Mean
2772879|NCT00720330|Secondary|Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents|The cumulative opioid consumption is calculated as fentanyl equivalent|From admission to the end of surgery||||mcg||Standard Deviation|Mean
2772825|NCT00720499|Secondary|PEFR AUC (6-12h) Response|"PEFR AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29|FAS|||Litres / minute||Standard Error|Mean
2772826|NCT00720499|Secondary|PEFR Peak 0-3h Response|"PEFR peak 0-3h response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres / minute||Standard Error|Mean
2772827|NCT00720499|Secondary|PEFR AUC (0-3h) Response|"Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres / minute||Standard Error|Mean
2772828|NCT00720499|Secondary|FVC Peak 0-3h Response|"FVC peak 0-3h response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772829|NCT00720499|Secondary|FVC AUC (0-6h) Response|"FVC AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772830|NCT00720499|Secondary|FVC AUC (0-3h) Response|"FVC AUC (0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
2772831|NCT00720499|Secondary|Individual FVC Measurements|"Individual FVC measurements [L] at each time point~The categories correspond to the planned times for FVC measurements on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772832|NCT00720499|Secondary|Trough FVC Response|"Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772833|NCT00720499|Secondary|FEV1 (Unsupervised) AUC (6-12h) Response|"FEV1 (unsupervised) AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|6 hours (h), 9h and 12h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772834|NCT00720499|Secondary|FEV1, AUC (0-6h) Response|"FEV1, AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772835|NCT00720499|Secondary|FEV1 Peak 0-3h Response|"FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
2772836|NCT00720499|Secondary|FEV1 AUC 0-3h, Response|"FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
2772837|NCT00720499|Secondary|Individual FEV1 Measurements|"Individual FEV1 measurements [L] at each time point on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
2772880|NCT00720330|Primary|Postoperative Opioid Consumption in Oral Oxycodone Equivalents|The cumulative opioid consumption after surgery until the end of second postoperative day.|2 days after surgery||||mg||Full Range|Mean
2772838|NCT00720499|Secondary|Trough FEV1 Response [L] After 2 Weeks of Treatment|"Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15|FAS|||Litres||Standard Error|Mean
2772839|NCT00720499|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.|"Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|Full analysis Set (FAS) which included all randomized patients who received at least one dose of study medication and had baseline data and Washout Period for at least 1 efficacy endpoint for each treatment period.|||Litres||Standard Error|Mean
2772840|NCT00720473|Primary|Means of MADRS Scores at 8 Weeks|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|8 Weeks|MADRS scores were available for 16 bipolar subjects who completed the protocol and 8 healthy controls.|||units on a scale||Standard Deviation|Mean
2772841|NCT00720473|Primary|Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|Baseline|MADRS scores were available for 27 eligible bipolar subjects and 14 eligible controls.|||units on a scale||Standard Deviation|Mean
2772842|NCT00720473|Primary|Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||NAA:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
2772843|NCT00720473|Primary|Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Gln:Cr/-10 MADRS Score||95% Confidence Interval|Least Squares Mean
2772844|NCT00720473|Primary|Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 Weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Glu:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
2772845|NCT00720473|Primary|Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks||||NAA to creatine ratio||95% Confidence Interval|Least Squares Mean
2772846|NCT00720473|Primary|Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks||||serum Glutamine to Creatine ratio||95% Confidence Interval|Least Squares Mean
2772847|NCT00720473|Primary|Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 Weeks||||serum Glutamate to Creatine ratio||95% Confidence Interval|Least Squares Mean
2772848|NCT00720473|Primary|Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline|Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|Baseline|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Glu:Cr/+10 MADRS||95% Confidence Interval|Least Squares Mean
2772849|NCT00720473|Primary|Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||Mean NAA to creatine ratio||Standard Deviation|Mean
2772850|NCT00720473|Primary|Mean Glutamate to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||mean serum Glutamate to Creatine ratio||Standard Deviation|Mean
2772851|NCT00720473|Primary|Mean Glutamine to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||mean serum Glutamine to Creatine ratio||Standard Deviation|Mean
2772852|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.|||log10 IU/mL||Standard Deviation|Mean
2776145|NCT00699660|Secondary|PTSD Diagnosis|Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).|Post-exam, same day||||participants|||Number
2772853|NCT00720434|Secondary|Population Pharmacokinetics (PK) of PF-00868554|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28|||||||
2772854|NCT00720434|Secondary|Alanine Aminotransferase (ALT) Levels||Week 4, 12, 48, 72|FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
2772855|NCT00720434|Secondary|Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.|Week 4, 12, 48, 60, 72|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.|||proportion of participants||95% Confidence Interval|Number
2772856|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||log10 IU/mL||Standard Deviation|Mean
2772857|NCT00720382|Other Pre-specified|Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|change from baseline to 12 months||||Units on a scale||Standard Deviation|Least Squares Mean
2772858|NCT00720382|Primary|Change From Baseline on Direct Visual Nasal Exams to 12 Months|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|Change from baseline to 12 months||||Participants|||Number
2772859|NCT00720369|Secondary|We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.|"The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points.~Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group."|8 week trial|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.|||units on a scale||Standard Deviation|Mean
2772860|NCT00720369|Primary|We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).|The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.|8 week trial||||per second||Standard Deviation|Mean
2772861|NCT00720356|Post-Hoc|Median Progression Free Survival|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|From the start of treatment and every 2 cycles, where 1 cycle equals 28 days, during treatment. Median follow up at time of data was 33 months.|Two patients were not evaluable|||months||95% Confidence Interval|Median
2772862|NCT00720356|Post-Hoc|Overall Survival at 24 Months|Overall Survival (OS) will be measured from start of treatment until death of any cause|At 24 months from first treatment|Two patients were not evaluable|||percentage of patients|||Number
2772863|NCT00720356|Post-Hoc|Overall Survival at 12 Months|Overall Survival (OS) is measured from start of treatment until death from any cause.|At 12 months from start of treatment|Two patients were not evaluable|||percentage of patients|||Number
2772864|NCT00720356|Post-Hoc|Progression Free Survival at 6 Months|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|At 6 months from start of treatment|Two patients were not evaluable.|||percentage of patients|||Number
2772865|NCT00720356|Other Pre-specified|Gene Methylation Studies (Optional)|Tissue and plasma collected from consenting patients in the study will be used to correlate tumor tissue with imaging and outcomes. Tissue will be collected before treatment on study begins and plasma will be collected the first day of treatment (before treatment) and every odd cycle after that, whilst on study treatment. Tissue and plasma analysis will be correlated with patients imaging results and response to to treatment|At baseline and then plasma only will be collected every odd cycle (1 cycle = 28 days) during treatment for a maximum of 49 cycles.|This was an optional portion of the study for consenting patients. No data was collected and analyzed for this outcome measure.||||||
2772866|NCT00720356|Other Pre-specified|Changes in Tumor Blood Flow Based on MR Perfusion|Data from consenting patients will be used to assess of changes in tumor blood flow based on MR perfusion using MRI scans. Two scans will be completed prior to treatment on study; the first after surgery buta before radiation, the second within 14 days before starting combination treatment or erlotinib and bevacizumab. Then scans will be completed every 2 cycles during treatment, where one cycle equals 28 days.|Prior to study treatment (after surgery, but before radiation), just before study treatment (within 14 days prior to first treatment) and then every 2 cycles during study treatment, where 1 cycle equals 28 days for a maximum of 49 cycles.|This was an optional portion of the study that patients could participate in. Data was not collected or analyzed for this outcome measure.||||||
2772867|NCT00720356|Secondary|Progression Free Survival at 18 Months|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|At 18 months from start of treatment|Most patients had progressed before the 18 month time point. Data was not collected for PFS at 18 months.||||||
2772868|NCT00720356|Secondary|Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population|"Toxicity data for combination treatment of erlotinib and bevacizumab will be collected on day 1 of every cycle (1 cycle = 28 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|From the start of treatment, at the beginning of every cycle (1 cycle = 28 days) during treatment until 30 days after completion of treatment for up to 49 cycles.|All patients that received at least one dose of study drug were evaluable for toxicity. Data for grade 3 and 4 toxicities during treatment were collected.|||patients|||Number
2772869|NCT00720356|Secondary|Response Rate (RR)|"Response Rate (RR) will be defined as the best response seen during treatment measured by CT/MRI scan every 8 weeks during treatment using McDonald Criteria.~CR=Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients off steroids.~PR=Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/decreased dose of steroids.~Stable/No Response=Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration. Stable/decreased dose of steroids.~Progressive disease = 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), worsening of evaluable disease, new lesions/site, failure to return for evaluation due to death or deteriorating condition."|From the start of treatment, every 2 cycles (1 cycle = 28 days) during treatment until progressive disease|Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient complete one cycle of treatment only)|||Participants|||Count of Participants
2772870|NCT00720356|Secondary|Progression-free Survival at 12 Months|Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death.|At 12 months from start of treatment|Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient completed one cycle)|||percentage of patients|||Number
2772871|NCT00720356|Primary|Overall Survival|Overall survival (OS) will be measured from the start of treatment until death from any cause. At data cut off patients remaining alive will be censored at the last known date of contact.|From start of treatment, during treatment and every 3 months following the end of treatment until death. Median follow up at time of OS data was 33 months.|2 patients were not evaluable - 1 patient withdrew consent and 1 patient completed less than 1 cycle of treatment|||Months||95% Confidence Interval|Median
2772872|NCT00720343|Secondary|Prevalence of Opioid Use||24 hours after surgery|||||||
2772873|NCT00720343|Secondary|Prevalence of High Blood Choline Concentration||24 hours after surgery|||||||
2772874|NCT00720343|Secondary|Prevalence of Nausea||24 hours after surgery|||||||
2772875|NCT00720343|Primary|Prevalence of Pain||24 hours after surgery|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.||||||
2772876|NCT00720330|Secondary|Postoperative Nausea|Number of patients who had postoperative nausea or vomiting were recorded.|After surgery until the second postoperative day.||||Participants|||Count of Participants
2772877|NCT00720330|Secondary|Pain Scores on Numerical Rating Scale|Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.|After surgery until the second postoperative mornings.||||units on a scale||Standard Deviation|Mean
2772881|NCT00720278|Secondary|Change From Baseline on Direct Visual Nasal Exams|"Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.~Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation"|14 days||||Participants|||Number
2772882|NCT00720278|Secondary|Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 days||||28 item/7 domain RQLQ on 0-6 scale||Standard Deviation|Least Squares Mean
2772883|NCT00720278|Secondary|Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||Reflective secondary symptom score||Standard Deviation|Least Squares Mean
2772884|NCT00720278|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 Days||||total nasal symptom score||Standard Deviation|Least Squares Mean
2772885|NCT00720278|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||total nasal symptom score||Standard Deviation|Least Squares Mean
2772886|NCT00720226|Secondary|Change in FEV1 (L)|Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.|Measured at Baseline and Month 12|Participants with 5-35% emphysema at baseline who had HRCT scans performed both at baseline and at 12 months.|||L (BTPS)||Standard Deviation|Mean
2772887|NCT00720226|Primary|Change in Percent Emphysema on CT Scan|Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.|Change between baseline and month 12.|Participants with 5-35% emphysema on baseline CT scan|||% Emphysema Whole Lung||Standard Deviation|Mean
2772888|NCT00720213|Secondary|Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.|The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.|2 nights|This was not part of the standard scoring of the PSG, therefore this was not calculated||||||
2772889|NCT00720213|Secondary|Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.|This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.|2 nights|During scoring of the PSG the modified hypopnea rule wasn't utlized therefore this data is not provided.||||||
2772890|NCT00720213|Secondary|Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)|Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.|2 nights||||percentage of oxygen saturation||Standard Deviation|Mean
2772891|NCT00720213|Secondary|Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']|The number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.|2 nights||||events per hour||Standard Deviation|Mean
2772892|NCT00720213|Secondary|Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)||2 nights||||minutes||Standard Deviation|Mean
2772893|NCT00720213|Secondary|Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.|These measures are the amount of time patients spent in each stage of sleep in minutes.|2 nights||||minutes||Standard Deviation|Mean
2772894|NCT00720213|Secondary|Sleep Efficiency|Sleep efficiency is a measure of how much a participant slept over the night. This is calculated by comparing the total sleep time and the total recording time * 100.|2 nights||||percentage efficiency||Standard Deviation|Mean
2772895|NCT00720213|Secondary|Total Sleep Time|Total sleep time is the total time the participant was asleep after sleep onset. This is calculated by adding the total number of minutes the participant was asleep during the night after sleep onset.|2 nights||||minutes||Standard Deviation|Mean
2772896|NCT00720213|Secondary|Wake After Sleep Onset|Wake after sleep onset refers to periods of wakefulness occurring after defined sleep onset. This was calculated by adding the total number of minutes the participant was awake after sleep onset.|2 nights||||minutes||Standard Deviation|Mean
2772897|NCT00720213|Secondary|Rapid Eye Movement (REM) Onset Latency|Rapid eye movement latency is the time from the sleep onset to the first epoch of REM sleep; therefore, it depends on the patient's sleep latency.|2 nights|This data was not part of the scoring PSG criteria and therefore not collected.||||||
2776146|NCT00699660|Primary|Completeness and Quality of PTSD Interview|total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment|Post-exam, same day||||percentage of criteria PTSD assessment||Standard Deviation|Mean
2772898|NCT00720213|Secondary|Sleep Onset Latency|Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.|2 nights||||minutes||Standard Deviation|Mean
2772899|NCT00720213|Secondary|Hypopnea Index|"Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal.~A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour."|2 nights||||events/hour||Standard Deviation|Mean
2772900|NCT00720213|Secondary|Mixed Apnea Index|"Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms~A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour."|2 nights||||events/hour||Standard Deviation|Mean
2772901|NCT00720213|Secondary|Obstructive Apnea Index|"Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway.~A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour."|2 nights||||events/hour||Standard Deviation|Mean
2772902|NCT00720213|Secondary|Central Apnea Index|"The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort.~A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour."|2 nights||||events/hour||Standard Deviation|Mean
2772903|NCT00720213|Secondary|Apnea Hypopnea Index- REM and NREM|"The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement)~A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM."|2 nights|Data was not scorable for NREM.|||events/hour||Standard Deviation|Mean
2772904|NCT00720213|Primary|Apnea Hypopnea Index|"The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal.~A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour."|2 nights||||events/hour||Standard Deviation|Mean
2772905|NCT00720122|Primary|Change in Spine Bone Density (g/cm^2)|Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.|Baseline and 6 months|The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.|||gm/cm^2||Standard Error|Mean
2772906|NCT00720109|Secondary|Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)|An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.|From the time entry on study to first event or date of last follow-up, assessed up to 7 years|Included in the analysis are two patients who received the drug therapy but were not risk classified.|||percentage of patients||90% Confidence Interval|Number
2772907|NCT00720109|Secondary|Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation|A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.|At end of consolidation (at 11 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percentage of participants||90% Confidence Interval|Number
2772908|NCT00720109|Secondary|Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy|Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.|At the end of induction therapy (at 5 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percentage of participants||90% Confidence Interval|Number
2772909|NCT00720109|Primary|Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events|Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)|Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)|||Pts with DLTs|||Number
2772910|NCT00720109|Primary|Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy|Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.|At 3 years|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percent probability||90% Confidence Interval|Number
2772911|NCT00720096|Secondary|Response Rate|Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.|1 year, 2 months|Data was not collected for this Pilot study, due to small sample size and early termination.||||||
2772912|NCT00720096|Primary|Interpret Genomic Array|Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.|1 year, 2 months|All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.|||Participants|||Number
2772913|NCT00720096|Primary|Assess Feasibility|Number of patients meeting 3 week feasibility window which was set as the benchmark.|1 year, 2 months|Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.|||Participants|||Number
2772914|NCT00720083|Primary|Disease-free Survival|This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.|From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.|||||||
2772915|NCT00720057|Secondary|Time to Onset of Effect|"Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them."|from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours|Efficacy analyses are based on ITT population (n=312).|||hours||Full Range|Median
2772916|NCT00720057|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).|at 24 hours postdose or immediately before first use of rescue medication|Efficacy analyses are based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
2772917|NCT00720057|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.|postdose to first use of rescue medication|Efficacy analyses are based on ITT population (n=312).|||hours||Full Range|Median
2772918|NCT00720057|Secondary|Summed Pain Intensity Difference at Specific Time Intervals|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.|0-16 hours post dose|Efficacy analyses were based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
2772919|NCT00720057|Secondary|Total Pain Relief (TOTPAR)|Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|0-24 hours post dose|Efficacy analyses were based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
2772920|NCT00720057|Primary|Summed Pain Intensity Difference (SPID)|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.|0 to 24 hours post dose|Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).|||units on a scale||Standard Deviation|Mean
2772921|NCT00719953|Primary|Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|Base line and 12 weeks||||Points on a scale||Standard Error|Mean
2772922|NCT00719914|Primary|Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)||30 days|study terminated due to low enrollment||||||
2772923|NCT00719901|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)|"Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment."|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.||||||
2772924|NCT00719901|Secondary|Time to Treatment Failure (Phase II)|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|Time from study entry to the date patients end treatment|No participants proceeded to Phase II for evaluation.||||||
2772925|NCT00719901|Secondary|Overall Survival (Phase II)|The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|No participants proceeded to Phase II for evaluation.||||||
2772926|NCT00719901|Secondary|Time to Progression (Phase II)|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time from registration to the time of progression|No participants proceeded to Phase II for evaluation.||||||
2772927|NCT00719901|Secondary|Number of Patients Who Have at Least a Partial Response (Phase I)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years||||participants|||Number
2772928|NCT00719901|Primary|Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.||||||
2773216|NCT00717977|Primary|Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group|The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.|48-72 hours||||Percent||Inter-Quartile Range|Median
2772929|NCT00719901|Primary|Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)|DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.|Up to 21 days of every first course||||Toxicity Incidents|||Number
2772930|NCT00719862|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days||||Participants|||Number
2772931|NCT00719862|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days||||Units on a scale||Standard Deviation|Least Squares Mean
2772932|NCT00719862|Secondary|Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days||||Refecltive secondary symptom score||Standard Deviation|Least Squares Mean
2772933|NCT00719862|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days||||total nasal symptom score||Standard Deviation|Least Squares Mean
2772934|NCT00719862|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||scores on a scale||Standard Deviation|Least Squares Mean
2772935|NCT00719862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||scores on a scale||Standard Deviation|Least Squares Mean
2772936|NCT00719849|Secondary|Incidence of Relapse at 2 Years|"Number of participants with relapse at 2 years.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|2 years post transplant||||Participants|||Count of Participants
2772937|NCT00719849|Secondary|Incidence of Relapse at 1 Year|"Number of participants with relapse at 1 year.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|1 year post transplant||||Participants|||Count of Participants
2772938|NCT00719849|Secondary|Probability of Progression-free Survival at 2 Years|Kaplan-Meier estimate of the probability of progression-free survival at 2 years|2 years post transplant||||progression free survival probability||95% Confidence Interval|Number
2772939|NCT00719849|Secondary|Probability of Progression-free Survival at 1 Year|Kaplan-Meier estimate of the probability of progression-free survival at 1 year|1 year post transplant||||progression free survival probability||95% Confidence Interval|Number
2772940|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 2 Years|Number of participants with clinically significant infections at 2 years|2 years post transplant||||Participants|||Count of Participants
2772941|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 1 Year|Number of participants with clinically significant infections at 1 year|1 year post transplant||||Participants|||Count of Participants
2772942|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 6 Months|Number of participants with clinically significant infections at 6 months|6 months post transplant||||Participants|||Count of Participants
2772973|NCT00719680|Secondary|Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations|Mean of individual median total IgG trough concentration.|Before infusion at Weeks 1, 24, 48, 72, and 96|The ITT population comprised all subjects treated with study medication during any study period.|||g/L||Standard Deviation|Mean
2772943|NCT00719849|Secondary|Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year|"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.~Clinical Limited cGVHD~Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.~Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.~Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.~Ocular sicca (Schirmer's test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.~Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD."|1 year post transplant||||Participants|||Count of Participants
2772944|NCT00719849|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant||||Participants|||Count of Participants
2772945|NCT00719849|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant||||Participants|||Count of Participants
2772946|NCT00719849|Secondary|Incidence of Platelet Engraftment at 6 Months|Number of participants with platelet engraftment at 6 months|6 months post transplant||||Participants|||Count of Participants
2772947|NCT00719849|Secondary|Incidence of Neutrophil Engraftment at Day 42|Number of participants with neutrophil engraftment at day 42|Day 42 post transplant||||Participants|||Count of Participants
2772948|NCT00719849|Secondary|Chimerism|Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.|7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant||||Participants|||Count of Participants
2772949|NCT00719849|Secondary|Incidence of Non-relapse Mortality at 6 Months|Number of Participants with Non-relapse Mortality at 6 Months|6 months post transplant||||Participants|||Count of Participants
2772950|NCT00719849|Secondary|Probability of Survival at 2 Years|Kaplan-Meier estimate of the probability of survival at 2 years|2 years post transplant||||survival probability||95% Confidence Interval|Number
2772951|NCT00719849|Primary|Probability of Survival at 1 Year|Kaplan-Meier estimate of the probability of survival at 1 year|1 year post transplant||||survival probability||95% Confidence Interval|Number
2772952|NCT00719810|Secondary|Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection.|||Participants|||Number
2772953|NCT00719810|Primary|Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen.|||Participants|||Number
2772954|NCT00719732|Primary|Uncorrected Visual Acuity (UCVA)|"Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|6 months||||logMAR||Standard Deviation|Mean
2772955|NCT00719706|Secondary|Phosphorus MRS Scans on 4T Scanner|Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.|Baseline to 12 weeks|At baseline, the number of participants analyzed was the number entered into the imaging portion of the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 10 participants in each category.|||units on a scale||Standard Deviation|Mean
2772956|NCT00719706|Primary|Clinical Global Impression-Severity|"Scores could range from 0 - 7 units on a scale, with 0 representing the least severe (Normal, not at all ill) and 7 representing the most severe (Among the most extremely ill patients)."|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
2772957|NCT00719706|Primary|The Young Mania Rating Scale|The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
2772958|NCT00719706|Primary|The Montgomery-Asberg Depression Rating Scale|Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
2772959|NCT00719706|Primary|The 25-Item Hamilton Depression Rating Scale.|Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.|Baseline to 15 Weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
2772960|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers|Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
2772961|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters|Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
2772962|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs|Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.|At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
2772963|NCT00719680|Secondary|Number of Subjects Reporting Mild, Moderate, or Severe Local AEs|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
2772964|NCT00719680|Secondary|Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion|"The rate of AEs was the number of AEs over the number of infusions administered.~AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion."|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.|||AEs per infusion|Participants||Number
2772965|NCT00719680|Secondary|Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion|AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
2772966|NCT00719680|Secondary|Relatedness and Severity of All AEs (Percentage of Total AEs)|"At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.|||percentage of total AEs|Participants||Number
2772967|NCT00719680|Secondary|Rate of All AEs by Relatedness and Severity|"The rate of AEs was the number of AEs over the number of infusions administered.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period.|||AEs per infusion|Participants||Number
2772968|NCT00719680|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
2772969|NCT00719680|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
2772970|NCT00719680|Secondary|Number of Days of Hospitalization Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days||Standard Deviation|Mean
2772971|NCT00719680|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
2772972|NCT00719680|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days||Standard Deviation|Mean
2772974|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Per-Protocol Efficacy population comprised all subjects who completed at least 48 weeks of the efficacy period that started with the first IgPro20 dose in this study.|||infections per subject year|Participants||Number
2772975|NCT00719680|Secondary|Annualized Rate of Any Infection|The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||infections per subject year|Participants||Number
2772976|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Intention-to-Treat (ITT) population comprised all subjects treated with study medication during any study period.|||infections per subject year|Participants||Number
2772977|NCT00719615|Primary|Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.|We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml.|Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database|"This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome the proportion of persons with vitamin D deficiency, a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25."|||participants|||Number
2772978|NCT00719576|Secondary|Participants With Treatment-Emergent Adverse Events||Week 104||||Participants|||Count of Participants
2772979|NCT00719576|Secondary|Change From Baseline at Week 104 in the Remaining 3 Subscales of the KOOS Instrument (Activities of Daily Living, Knee-related Quality of Life, and Other Symptoms)|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems).|Baseline and Week 104||||units on a scale||Standard Deviation|Mean
2772980|NCT00719576|Secondary|Treatment Failure|"The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. As such, the number of participants with treatment failure is being reported.~Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient's global assessment of their knee joint compared to Baseline was the same or worse~Physician's global assessment of the patient's knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or autologous cultured chondrocyte implantation."|Week 104||||Participants|||Count of Participants
2772981|NCT00719576|Secondary|Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104.|A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from Baseline|Week 104||||Participants|||Count of Participants
2772982|NCT00719576|Secondary|Assessment of Defect Fill by Magnetic Resonance Imaging (MRI)|"Number of participants with MRI degree of defect fill > 50%. Evaluation of MRI data was performed by independent central review blinded to the participant's treatment.~Appropriate MRI sequences were used to image cartilage repair tissue."|Week 104|Number of participants with MRI data at Week 104|||Participants|||Count of Participants
2772983|NCT00719576|Secondary|Histological Evaluation of Structural Repair of Evaluable Biopsies Harvested From the Core of the Index Lesion During Arthroscopy at Week 104|"The mean microscopic International Cartilage Repair Society (ICRS) II overall assessment score was used to assess the histology efficacy endpoint.~Scoring of the cartilage repair biopsies was completed using the ICRS II histology scoring system (Mainil-Varlet, 2010, Am J Sports Med) by 2 independent pathologists blinded to the patient's assigned study treatment. This scoring system includes 14 parameters, comprising an overall assessment score reported here, as well as 13 other items related to chondrocyte phenotype, tissue structure, and other factors, each scored on a scale from 0 to 100 representing poor to good quality cartilage."|Week 104|includes all subjects with histology follow-up data|||units on a scale||Full Range|Least Squares Mean
2772984|NCT00719576|Primary|Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores.|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|Baseline and Week 104|All randomized patients|||units on a scale||Standard Deviation|Mean
2776337|NCT00697593|Primary|Hematology - Basophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
2772985|NCT00719563|Secondary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and Week 4|The analysis was not able to be done due to the low numbers of minorities accrued.||||||
2772986|NCT00719563|Secondary|Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.|||units on a scale||Standard Deviation|Mean
2772987|NCT00719563|Secondary|Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.|||units on a scale||Standard Deviation|Mean
2772988|NCT00719563|Secondary|Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
2772989|NCT00719563|Secondary|Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
2772990|NCT00719563|Secondary|Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
2772991|NCT00719563|Secondary|Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
2772992|NCT00719563|Secondary|Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
2772993|NCT00719563|Secondary|Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
2773006|NCT00719355|Primary|Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test|Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).|Baseline and 24 weeks|Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.|||minutes||Standard Deviation|Mean
2773007|NCT00719329|Primary|Colonization at Day 7 Swab|Were any organisms found on the swab collected on the day 07 visit?|First Week of Life|Intent to Treat|||Participants|||Number
2772994|NCT00719563|Secondary|Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
2772995|NCT00719563|Secondary|Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
2772996|NCT00719563|Secondary|Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Week 1 to Week 8|Includes all participants that reported at least one value after baseline.|||participants|||Number
2772997|NCT00719563|Primary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
2772998|NCT00719537|Primary|Incidence of Preeclampsia|Number of Participants with preeclampsia in second and third trimester of pregnancy.|second and third trimester of pregnancy|1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.|||Participants|||Count of Participants
2772999|NCT00719472|Secondary|Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)|Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).|Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.|||Percentage of participants|||Number
2773000|NCT00719472|Secondary|Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)|Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.|Day 1 of Cycles 2 and either 6 or 8 (last cycle)|Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.|||µg/mL||Standard Deviation|Mean
2773001|NCT00719472|Secondary|Duration of Rituximab Infusion Including Dose Interruption Times|The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.|Day 1 of each of Cycles 1 to 6 or 8|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Minutes||Inter-Quartile Range|Median
2773002|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)||Cycle 2 through Cycle 6 or 8 (end of study)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Percentage of participants|||Number
2773003|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1||Cycle 1|Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate.|||Percentage of participants|||Number
2773004|NCT00719472|Primary|Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2|The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate.|Days 1 and 2 of Cycle 2|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Percentage of participants||95% Confidence Interval|Number
2773005|NCT00719355|Secondary|Onset of Claudication Pain During Constant Work Rate Treadmill Test|Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.|At 24 weeks|Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.|||minutes||Standard Deviation|Mean
2773010|NCT00719264|Secondary|Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab|This outcome measure was assessed continuously.|From the date of the first participant treated until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.|||weeks||Full Range|Median
2773011|NCT00719264|Secondary|Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
2773012|NCT00719264|Secondary|Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units|The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
2773013|NCT00719264|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths|Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.|From the first participant randomized until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.|||Participants|||Number
2773014|NCT00719264|Secondary|Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.|Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.|A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.|||Months||95% Confidence Interval|Median
2773015|NCT00719264|Secondary|Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.|||Number of participants|||Number
2773016|NCT00719264|Secondary|Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.|Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
2773088|NCT00718809|Secondary|Overall Survival|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|Time from the date of registration to last reported date of survival, assessed up to 5 years|All patients who enrolled and received treatment|||months||95% Confidence Interval|Median
2773017|NCT00719264|Primary|Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
2773018|NCT00719212|Secondary|Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat|||months||95% Confidence Interval|Median
2773019|NCT00719212|Secondary|Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.|"The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:~Patients with elevated CA 125 pretreatment and normalization of CA 125 needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart or~Patients with elevated CA 125 pretreatment, which never normalizes needed to show evidence of CA 125 greater than, or equal to, two times the nadir value on two occasions at least 1 week apart or~Patients with CA 125 in the normal range pretreatment needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart."|Day 1 of each cycle|Intent To Treat|||months||95% Confidence Interval|Median
2773020|NCT00719212|Secondary|Overall Survival (OS) Investigator Assessment|Interval between the date of registration and the date of death|Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first|Intent To Treat|||months||95% Confidence Interval|Median
2773021|NCT00719212|Secondary|Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts|"RECIST(v1.0):~CR:disappearance of all target les°&non-target les°&normalization of tumor marker level~PR:at least 30% decrease in the sum of the LD of target les°-ref the baseline sum LD OR CR for target les°&incomplete resp/SD for non target les°~SD:insufficient shrinkage for PR or increase for PD-ref the smallest sum LD since ttmt started or Persistence of one/more non-target les°or/&maintenance of tumor marker level above the normal~CA125 level:~PR:elev of CA125 at baseline PR if a ≥ 50% decrease compared to baseline value observed on 2 consec assessmts drawn at least 1 wk apart~CR:elev of CA125 at baseline CR 2 CA125 below ULN observed on 2 consec assessmts drawn at least 1 wk apart~SD:neither CR/PR nor PD~Best overall resp of :~CR:if CR per RECIST & per CA125~PR:if CR per RECIST & PR per CA125 OR CR per RECIST and SD per CA125 with elev CA125 at baseline OR PR per RECIST & CR/PR or SD per CA125~SD:other cases not qualifying for progression-at least 24 wks"|At 16 weeks from registration|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
2773022|NCT00719212|Primary|Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
2773023|NCT00719212|Secondary|Time To Progression (TTP) Investigator Assessment|Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat|||months||95% Confidence Interval|Median
2773024|NCT00719212|Primary|Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
2773025|NCT00719186|Secondary|Neonatal Complication Rate||September 2008 - December 2011|Neonatal complications reported per infant, an infant could have more than one complication.|||participants|||Number
2773026|NCT00719186|Secondary|Number of Serious Adverse Events||as few as 5 months, up to 16 months||||events|||Number
2773027|NCT00719186|Secondary|Number of Ovulations||as few as 5 months, up to 16 months||||ovulations|||Number
2773028|NCT00719186|Secondary|Number of Pregnancy||as few as 5 months, up to 16 months||||Participants|||Count of Participants
2773029|NCT00719186|Primary|Live Birth|The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.|as few as 5 months, up to 16 months||||Participants|||Count of Participants
2773030|NCT00719160|Secondary|Gastric pH|"The American Heritage Dictionary defines pH as a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14. The normal pH range for stomach acid is between 1.5 and 3.5."|Day 5 of a high protein diet||||units on a scale of pH||Standard Error|Mean
2773031|NCT00719160|Primary|Percent Change in Intestinal Calcium Absorption|This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.|Day 5 of a high protein diet||||percentage of calcium absorption||Standard Error|Mean
2773032|NCT00719134|Secondary|Pain Free at 2 Hours After Treatment|A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.|2 hours after treatment|For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.|||percent of patients pain free||95% Confidence Interval|Number
2773033|NCT00719134|Primary|Change in Headache Intensity|The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).|2 hours after treatment|For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.|||percent change||95% Confidence Interval|Mean
2773034|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773035|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|"A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.~This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups."|At Days 10 and 42|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773036|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
2773037|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Day 0, Day 10, Day 42, Day 182 and Day 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
2773038|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 0, 10, 42, 182, 549 and 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
2773039|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 10, 42, 182 and 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
2773040|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
2773041|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
2773042|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
2773043|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
2773044|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
2773053|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
2773045|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
2773046|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773047|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773048|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
2773049|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
2773050|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773051|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773052|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773086|NCT00718809|Secondary|Expected Toxicities Including Skin Rashes and Diarrhea|Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.|Up to 5 years|All patients|||participants|||Number
2773054|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773055|NCT00719043|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
2773056|NCT00719043|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.|Within the 43-day (Days 0-42) post-vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
2773057|NCT00719043|Primary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
2773058|NCT00719043|Primary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
2773059|NCT00719043|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
2773060|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773061|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773062|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
2773063|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
2776338|NCT00697593|Primary|Hematology - Eosinophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
2773064|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773065|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
2773066|NCT00718887|Secondary|Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results|Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.|Day 1 through Week 48|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
2773067|NCT00718887|Secondary|Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.|Continually from Day 1 through Week 48, and through 24-week follow-up period|"Participants who were randomized and received at least~1 dose of study drug."|||Participants|||Number
2773068|NCT00718887|Secondary|Number of Participants With Genotypic Resistance to Entecavir||At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||Participants|||Number
2773069|NCT00718887|Secondary|Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion||At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||Participants|||Number
2773070|NCT00718887|Secondary|Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion||At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants.|||Percentage of participants|||Number
2773071|NCT00718887|Secondary|Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)|ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN|At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were >1*ULN at baseline. n=number of evaluable participants.|||Percentage of participants|||Number
2773072|NCT00718887|Secondary|Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing|HBV=hepatitis B virus|At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||log10 IU/mL||Standard Deviation|Mean
2773073|NCT00718887|Secondary|Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing|HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
2773074|NCT00718887|Primary|Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing|HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 12 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
2773075|NCT00718861|Secondary|Change in Height at Years 7, 8 and 9 Relative to Year 6|Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with evaluable measurements at both Year 6 and the post-Year 6 visit, as determined by the analysis window.|||millimeters (mm)||Standard Error|Least Squares Mean
2773076|NCT00718861|Secondary|Mean of Time to First Clinical Fracture|The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.|over 3 years of study duration|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.|||Days||Standard Error|Mean
2773087|NCT00718809|Secondary|Disease Control Rate|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.|Up to 5 years|All patients who enrolled and received treatment|||months||95% Confidence Interval|Median
2773077|NCT00718861|Secondary|Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6|Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.|Year 6 (extension 2 baseline), Year 9 (3 years of study duration)|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n= the number of patients with the event|||participants|||Number
2773078|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
2773079|NCT00718861|Secondary|Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
2773080|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
2773081|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
2773082|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
2773083|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
2773084|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
2773085|NCT00718861|Primary|Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.|Year 6 (baseline) and Year 9|The modified intent-to-treat (MITT) population included all patients in the ITT population who had DXA measurements of the total hip at Visit 11 (Year 6) and Visit 15 (Year 9). This was the primary population for the primary efficacy parameter.|||Percentage Change of BMD||Standard Error|Least Squares Mean
2773089|NCT00718809|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Time from the date of registration to the first reported outcome event, assessed up to 5 years|All patients who enrolled and received treatment.|||months||95% Confidence Interval|Median
2773090|NCT00718809|Primary|Objective Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.|Up to 5 years|All patients with at least one post baseline measurement.|||percentage of participants||95% Confidence Interval|Number
2773091|NCT00718770|Primary|Change in Tumor Size|To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria|1 year|Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer|||cm||Standard Deviation|Mean
2773092|NCT00718718|Secondary|Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)|Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.|Baseline, Week 2|Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2773093|NCT00718718|Secondary|Serum Sirukumab Concentrations Through Week 38 (Part B)|Sirukumab Concentrations in serum were measured.|Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38|Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.|||Microgram per milliliter||Standard Deviation|Mean
2773094|NCT00718718|Secondary|Serum Sirukumab Concentrations Through Week 38 (Part A)|Sirukumab Concentrations in serum were measured.|Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38|Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.|||Microgram per milliliter||Standard Deviation|Mean
2773095|NCT00718718|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)|An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.|Week 12|Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2773096|NCT00718718|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.|Baseline, Week 12|Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.|||Units on a Scale||Standard Deviation|Mean
2773097|NCT00718718|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)|An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).|Week 12|Population analyzed included all randomized participants in Part B.|||Percentage of Participants|||Number
2773098|NCT00718666|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
2773099|NCT00718666|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
2773100|NCT00718666|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
2773101|NCT00718666|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.|||Participants|||Count of Participants
2773102|NCT00718666|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.|||Participants|||Count of Participants
2773103|NCT00718666|Secondary|Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers|Vaccine response was defined as: for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay.|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
2773104|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England [PHE] laboratory assay.|At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Titers||95% Confidence Interval|Geometric Mean
2773105|NCT00718666|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay.|At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
2773106|NCT00718666|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer < 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
2773107|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers|Titers were given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Titers||95% Confidence Interval|Geometric Mean
2773108|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all vaccinated subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix1 and Nimenrix 2 Group)|||Participants|||Count of Participants
2773109|NCT00718666|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Titers||95% Confidence Interval|Geometric Mean
2773110|NCT00718666|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Participants|||Count of Participants
2773111|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Titers||95% Confidence Interval|Geometric Mean
2773112|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Participants|||Count of Participants
2773113|NCT00718666|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773114|NCT00718666|Secondary|Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations|Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml).|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||μg/ml||95% Confidence Interval|Geometric Mean
2773115|NCT00718666|Secondary|rSBA Antibody Titers.|Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 5 (60 months following primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773116|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals' laboratory assay.|At Year 5 (60 months post-primary vacccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773117|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 3 (36 months following primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773161|NCT00718315|Secondary|Percentage of Participants With Erythema Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
2773118|NCT00718666|Secondary|rSBA Antibody Titers.|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay.|At Year 3 (36 months post-primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773119|NCT00718666|Secondary|rSBA Antibody Titers|Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773120|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay.|At Year 5 (60 months post-primary vacccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773121|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 5 (60 months post-primary vacccination).|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773122|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773123|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773124|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773125|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
2773126|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
2773127|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
2773128|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773129|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773130|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 1 (12 months post vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773131|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773132|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.|At Year 3 (36 months post primnary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773133|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
2773134|NCT00718640|Secondary|Renal Function|Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773135|NCT00718640|Secondary|Quality of Life Assessed by Euro Quality of Life (EQ-5D)|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773136|NCT00718640|Secondary|Quality of Life Assessment by QLQ C-30|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.|Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773137|NCT00718640|Secondary|Karnofsky Performance Status (KPS) Score|The KPS is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773138|NCT00718640|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.|Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773139|NCT00718640|Secondary|Duration of Response|The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.|Day 1 (Start of treatment) until the date of first documented achievement of response|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773140|NCT00718640|Secondary|Time to Progression (TTP) of Disease|The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.|Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773141|NCT00718640|Secondary|Best Response to Treatment|It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773142|NCT00718640|Primary|Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria|The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.|Week 24 or Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
2773143|NCT00718549|Secondary|Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129|MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment.|12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
2773144|NCT00718549|Secondary|Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29|MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment.|8 weeks after the last dose of rituximab during induction treatment (Week 29)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
2773145|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 129|CR was achieved if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment.|12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
2773146|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 29|CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment.|8 weeks after the last dose of rituximab during induction treatment (Week 29)|ITT population. Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among Participants included in Overall IIT population only.|||percentage of participants|||Number
2773147|NCT00718549|Secondary|PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors|PFS: time from date of randomization to date of PD, relapse, or death from any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in previously noted enlargement of liver or spleen by >/=50%; an increase in number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and clinical outcome (PFS) after study treatment.|From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||years||95% Confidence Interval|Median
2773148|NCT00718549|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR|MRD was defined by the presence of tumor cells in bone marrow, using 4-color flow cytometry of cluster of differentiation (CD)19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR: if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline).|8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||percentage of participants||95% Confidence Interval|Number
2773149|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL|CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, platelets (PL) >100,000/mcL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), bone marrow (BM) sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly (decrease in lymph node size by >/=50% compared to pre-treatment state, no increase in any lymph node, no new enlarged lymph node); a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline).|8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||percentage of participants||95% Confidence Interval|Number
2773150|NCT00718549|Primary|Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL|PFS was defined as the time from date of randomization to date of PD, relapse, or death due to any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.|From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||years||95% Confidence Interval|Median
2773162|NCT00718315|Secondary|Percentage of Participants With Pain|Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
2773163|NCT00718315|Secondary|Percentage of Participants With Pruritus|Pruritus is defined as intense localized itching|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
2776339|NCT00697593|Primary|Hematology - Neutrophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
2773151|NCT00718549|Primary|Percentage of Participants With Disease Progression (PD), Relapse, or Death Due to Any Cause Assessed According to the National Cancer Institute (NCI) Revised Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL)|PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (greater than [>]1.5 centimeters [cm]), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of greater than or equal to (>/=) 50 percent (%) in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000 per microliter (/mcL); transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.|From randomization to PD, Relapse, or death due to any cause (overall approximately 5 years)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-treatment efficacy measurement available. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2773152|NCT00718523|Secondary|Overall Survival (OS)|Interval between the date from randomization to death from any cause whichever came first.|Day 1 of each cycle up to 4 years after randomization|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
2773153|NCT00718523|Secondary|Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
2773154|NCT00718523|Primary|Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
2773155|NCT00718510|Secondary|Change From Baseline in Mean Calgary Depression Scale for Schizophrenia (CDSS) at 3 Weeks|The Secondary Outcome Measure was the Calgary Depression Scale for Schizophenia (CDSS). The CDSS is a 9-item scale that is used to rate the depressive symptoms in patients with schizophrenia. For each CDSS item, symptom severity was rated on a 3-point scale, from 0=absent to 3=severe. The CDSS total score ranges from 0 to 27 with a higher score indicating a greater severity of symptoms.|Baseline and 3 Weeks||||units on a scale||Standard Deviation|Mean
2773156|NCT00718510|Secondary|Change From Baseline in Mean Clinical Global Impression (CGI) Scale at 3 Weeks|The Secondary Outcome Measure was the Clinical Global Impression (CGI) scale. The CGI is a 3-item scale that rates treatment response and monitors the clinical course of all psychiatric illnesses including schizophrenia. Within the CGI, the Severity of Illness was rated on a 7-point scale, 0=not assessed to 7=among the most severely ill patients. For Global Improvement, the total improvement following treatment as compared to at baseline of the trial was rated on a 7-point scale, 0=not assessed to 7=very much worse.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis|||units on a scale||Standard Deviation|Mean
2773157|NCT00718510|Primary|Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks|The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score and PANSS positive, negative and general psychopathology subscale scores. The PANSS is a 30-item scale used to evaluate the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranges from 30 to 210 with a higher score indicating a greater severity of symptoms. The PANSS positive symptom subscale score (7 items) ranges from 7=absent to 49=extreme; the PANSS negative subscale score (7 items) ranges from 7=absent to 49=extreme; and the PANSS general psychopathology subscare score (16 items) ranges from 16=absent to 112=extreme.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis|||units on a scale||Standard Deviation|Mean
2773158|NCT00718328|Primary|Perihematomal Edema|Solitary patient lost to follow up (out of state)|Days 7 and 14||||Relative perihematomal edema||Standard Deviation|Mean
2773159|NCT00718315|Secondary|Percentage of Participants With Pain Stratified by Severity Grade|The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
2773160|NCT00718315|Secondary|Percentage of Participants With Pruritus Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
2773167|NCT00718315|Primary|Percentage of Participants Who Develop Skin Rash|"Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line Rash/desquamation - short name rash)."|30 Days|ITT Population|||percentage of participants||95% Confidence Interval|Number
2773168|NCT00718302|Secondary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
2773169|NCT00718302|Secondary|The Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 9 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
2773170|NCT00718302|Secondary|American Orthopedic Foot and Ankle Society Score (AOFAS) Scores|American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
2773171|NCT00718302|Secondary|Percentage Normal Peroneal Tendons|Percentage of Participants with Normal Peroneal Tendons|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||percentage of participants|||Number
2773172|NCT00718302|Primary|Percentage of Nonpalpable Hardware|Percentage of Participants with Nonpalpable Hardware|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP)|||percentage of participants|||Number
2773173|NCT00718237|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
2773174|NCT00718237|Primary|Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
2773175|NCT00718237|Secondary|Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
2773176|NCT00718159|Secondary|Pharmacokinetics: Concentration Maximum (Cmax) of LY573636|PK sample is withdrawn at any time on days 8,14,15,21,28.|Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dose|Participants who received the study drug and had pharmacokinetic (PK) data.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2773191|NCT00718042|Secondary|ESA Chagas Sensitivity in Serologically Positive Non-US Specimens|ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.|3 months|A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.|||participants|||Number
2773192|NCT00718042|Primary|ESA Chagas Sensitivity|Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.|3 months|Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.|||participants|||Number
2773177|NCT00718159|Secondary|Number of Participants With Bone Marrow (BM) Response|The International Working Group's revised recommendations were used to assess response in acute myeloid leukemia (AML): complete response (CR) is <5% blasts in BM and with a cell count ≥200 cells in BM, and with peripheral blood platelets ≥100x10⁹/liter (L) and absolute neutrophils ≥1x10⁹/L; CR with incomplete blood count recovery is defined as CRi; partial response (PR) is ≥5% blasts in BM but with ≥50% reduction in blast count. Number of responders for AML = CR+PR+ CRi. Result of a European Leukemia Net consensus conference was used to assess response in essential thrombocythemia (ET). CR is platelets ≤400x10⁹/L in peripheral blood, no disease-related symptoms, normal spleen size and white blood cells ≤10x10⁹/L in peripheral blood; PR has platelets ≤600x10⁹/L in peripheral blood or decrease > 50% from baseline but does not meet CR criteria. Number of responders for ET = CR+PR.|Baseline to measured progressive disease up to 70 days|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2773178|NCT00718159|Secondary|Pharmacokinetics Area Under the Curve(AUC) of LY573636 Above the Albumin-Corrected Threshold (AUCalb)|"LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.~PK sample is withdrawn at any time on days 8,14,15,21,28."|Predose,1h,2h,4h, 8d,14d,15d,21d,28d post dose|Participants who received the study drug and had pharmacokinetic (PK) data.|||micrograms*hour/milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2773179|NCT00718159|Primary|Recommended Phase 2 Dose of LY573636-Sodium in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Essential Thrombocythemia (ET)|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists >7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached.|Predose up to 35 days postdose in Cycle 1|No participants were analyzed since the MTD was not reached.||||||
2773180|NCT00718120|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
2773181|NCT00718120|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
2773182|NCT00718120|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
2773183|NCT00718120|Primary|Fold Increase From Baseline in Serum HI Antibody Titer|The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.|At Day 21||||fold increase|||Number
2773184|NCT00718120|Primary|Number of Seroprotected Subjects|Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.|At Day 0 and 21||||subjects|||Number
2773185|NCT00718120|Primary|Number of Seroconverted Subjects|Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.|At Day 21||||subjects|||Number
2773186|NCT00718120|Primary|Hemagglutination Inhibition (HI) Antibody Titers|Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.|At Day 0 and 21||||titer||95% Confidence Interval|Geometric Mean
2773187|NCT00718094|Primary|Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.|"This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity.~Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; >10: severe UC."|day 56||||Participants|||Count of Participants
2773188|NCT00718081|Secondary|Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief|At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.|Up to 12 hours after surgery||||percentage of patients|||Number
2773189|NCT00718081|Primary|SPID-12|The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.|12 hours after surgery||||units on a scale||Standard Error|Least Squares Mean
2773190|NCT00718042|Secondary|ESA Chagas Testing in Chagas Endemic Population|Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.|2 months|Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.|||participants|||Number
2773193|NCT00718042|Primary|ESA Chagas Specificity|Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.|3 months|Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.|||participants|||Number
2773194|NCT00718042|Secondary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.|A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.|15 months|A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.|||participants|||Number
2773195|NCT00718042|Secondary|PRISM Chagas Reactivity in Chagas Endemic Population|Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.|2 months|Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.|||participants|||Number
2773196|NCT00718042|Primary|PRISM Chagas Sensitivity|Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.|6 months|Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.|||participants|||Number
2773197|NCT00718042|Secondary|PRISM Chagas Reactivity Serology Positive Specimens|Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).|4 months|Total of 287 specimens presumed T cruzi antibody positive per protocol.|||participants|||Number
2773198|NCT00718042|Primary|PRISM Chagas Specificity|Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay [radioimmune precipitation assay (RIPA)].|6 months|All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.|||participants|||Number
2773199|NCT00717977|Primary|Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773200|NCT00717977|Primary|Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773201|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Time of Day|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||Percent||Inter-Quartile Range|Median
2773202|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Age Group|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||Percent||Inter-Quartile Range|Median
2773203|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Time of Day||48-72 hours||||mg/dL/min||Inter-Quartile Range|Median
2773204|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Age Group||48-72 hours||||mg/dL/min||Inter-Quartile Range|Median
2773205|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Time of Day|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773206|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Age Group|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773207|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours."|48-72 hours||||Percent||Inter-Quartile Range|Median
2773208|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
2773209|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
2773210|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
2773211|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours."|48-72 hours||||Percent||Inter-Quartile Range|Median
2773212|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
2773213|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
2773214|NCT00717977|Primary|Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
2773217|NCT00717977|Primary|Nighttime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773218|NCT00717977|Primary|Daytime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773219|NCT00717977|Primary|Peak Nightime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773220|NCT00717977|Primary|Peak Daytime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
2773221|NCT00717977|Primary|Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.|48-72 hours||||mg/dL||Standard Deviation|Mean
2773222|NCT00717977|Primary|Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.|48-72 hours||||mg/dL||Standard Deviation|Mean
2773223|NCT00717977|Primary|Overall Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.|48-72 hours||||mg/dL||Standard Deviation|Mean
2773224|NCT00717912|Secondary|Insulinemic Index|"The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.~Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge||||% of the GI of the glucose||Standard Deviation|Mean
2773225|NCT00717912|Primary|Glycemic Index|"The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.~Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge||||% of GI of the glucose||Standard Deviation|Mean
2773226|NCT00717886|Primary|Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).||2 years||||participants|||Number
2773227|NCT00717873|Primary|Hospital Length of Stay|an average of 10 days|Admission to Discharge||||days||Standard Deviation|Mean
2773228|NCT00717860|Secondary|Number of Participants With Favorable Overall Response at the End of Study Therapy|Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|Per Protocol Set (PPS) population.|||Participants|||Number
2773229|NCT00717860|Secondary|Number of Participants With a Specific Safety Finding|A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|APaT population.|||Participants|||Number
2773230|NCT00717860|Primary|Number of Participants With a Significant Drug-related Adverse Experience|A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|All Participants as Treated (APaT) population.|||Participants|||Number
2773231|NCT00717756|Primary|Response Rate by Recist Criteria|"radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD~It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed."|on average about every 2 months until progression, on average about 4 months.||||participants|||Number
2773232|NCT00717574|Primary|The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)|"We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O.~BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased."|From baseline to 20 minutes after the addition of 60% nitrous oxide||||units on a scale||Standard Deviation|Mean
2773246|NCT00717405|Secondary|Number of Participants Who Underwent Mastectomy|Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment.|Anytime between Week 26 and Week 29|ITT population.|||participants|||Number
2773247|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed. n included number of participants who were evaluable at a particular time point.|||percentage of participants|||Number
2773233|NCT00717522|Secondary|Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines|Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).|This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).||||||
2773234|NCT00717522|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs|An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.|AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).|All participants|||participants|||Number
2773235|NCT00717418|Other Pre-specified|Schirmer's Test With and Without Anesthesia at Baseline|Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit).|||millimeters (mm)||Standard Deviation|Mean
2773236|NCT00717418|Primary|Ocular Surface Disease Index (OSDI) Total Score at Baseline|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.|||Scores on a Scale||Standard Deviation|Mean
2773237|NCT00717405|Secondary|Overall Survival (OS) Duration|OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method.|Up to 5 years|ITT population.|||months||95% Confidence Interval|Median
2773238|NCT00717405|Secondary|Percentage of Participants Who Were Alive at 3 and 5 Years||3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
2773239|NCT00717405|Secondary|Recurrence Free Survival (RFS) Duration|RFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.|||months||95% Confidence Interval|Median
2773240|NCT00717405|Secondary|Percentage of Participants Who Were Recurrence Free at 3 and 5 Years|A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes).|3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
2773241|NCT00717405|Secondary|Disease Free Survival (DFS) Duration|DFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.|||months||95% Confidence Interval|Median
2773242|NCT00717405|Secondary|Percentage of Participants Who Were Disease Free at 3 and 5 Years|A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause.|3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
2773243|NCT00717405|Secondary|Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit||Baseline, Neoadjuvant Final Visit (Week 25)|Safety population: Number of participants included all the participants who received at least one infusion of bevacizumab. n included participants who were evaluable at that time point.|||Units per milliliter (U/mL)||Standard Deviation|Mean
2773244|NCT00717405|Secondary|Percentage of Participants Who Underwent Lymph Node Resection|Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.|||percentage of participants|||Number
2773245|NCT00717405|Secondary|Percentage of Participants With Macroscopically Visible Tumor|Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.|||percentage of participants|||Number
2773248|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed and were evaluated for response from baseline assessment of inflammatory signs. n included number of participants who were evaluable at a particular time point.|||percentage of participants|||Number
2773249|NCT00717405|Secondary|Percentage of Participants With a PCR According to the Chevallier Classification|PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2773250|NCT00717405|Primary|Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification|PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2773251|NCT00717366|Secondary|Apparent Terminal Phase Half-Life (t1/2) of MIRCERA|t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants evaluable for t1/2 assessments.|||hours||Geometric Coefficient of Variation|Geometric Mean
2773252|NCT00717366|Secondary|Time to Reach Cmax (Tmax) of MIRCERA|Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population.|||hours||Full Range|Median
2773253|NCT00717366|Secondary|Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA|Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants with AUC0-672h assessment at specified time-points.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2773254|NCT00717366|Secondary|Maximum Observed Serum Concentration (Cmax) of MIRCERA|Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Pharmacokinetic (PK) evaluable population included all enrolled participants who received at least one dose of study drug and had evaluable PK assessment. Here 'n' signifies number of participants evaluable at specified time-points.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2773255|NCT00717366|Secondary|Change in Average Reticulocyte Count Between the Baseline and Evaluation Period|A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.|||10^3 cells/microliter||Standard Deviation|Mean
2773256|NCT00717366|Secondary|Number of Participants With Blood Transfusions||Baseline to Week 20|ITT population.|||participants|||Number
2773257|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL|The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.|||participants|||Number
2773258|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb|Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.|||participants|||Number
2773259|NCT00717366|Primary|Change in Average Hb Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis.|||g/dL||Standard Deviation|Mean
2773260|NCT00717314|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52|The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.|Week 52|PP population|||percentage of participants|||Number
2773261|NCT00717314|Secondary|Percentage Change in Creatinine Clearance From Baseline|Creatinine clearance was calculated using the Cockcroft and Gault formula.|Weeks 16, 28, 40, and 52|PP population|||percentage change from baseline||Standard Deviation|Mean
2773262|NCT00717314|Secondary|Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52|Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Week 52|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.|||mL/min||95% Confidence Interval|Mean
2773263|NCT00717314|Secondary|Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])|Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Baseline and Weeks 16, 28, and 40|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
2773264|NCT00717314|Secondary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52|BPAR was graded according to Banff criteria.|Week 52|PP population|||percentage of participants|||Number
2773265|NCT00717314|Secondary|Percentage of Participants With Graft Loss or Death at Week 52|Graft loss was defined for this protocol as re-transplantion or death.|Week 52|PP population|||percentage of participants|||Number
2773266|NCT00717314|Primary|Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%|The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.|Week 52|PP population|||percentage of participants|||Number
2773267|NCT00717288|Secondary|Reversion to Intravenous Insulin for Failure of Glycemic Control|Number of participants who went back on intravenous insulin for failure of glycemic control.|72 hours||||participants|||Number
2773268|NCT00717288|Secondary|Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)|Number of patients with hypoglycemia (defined as glucose <65 mg/dl)|48 hours|Intention to treat (ITT)|||participants|||Number
2773269|NCT00717288|Primary|Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3|Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3|day 2, day 3|intention to treat (ITT)|||participants|||Number
2773270|NCT00717275|Primary|Number of Participants Who Developed Distant Brain Failure at One Year.||1 Year|Data was not analyzed.||||||
2773271|NCT00717249|Primary|Average Contact Lens Wear Time|The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.|6 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||time in hours||Full Range|Mean
2773272|NCT00717249|Primary|Visual Acuity|Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
2773273|NCT00717249|Primary|Subject Reported Symptoms|"Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported."|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Percentage of Observations|Participants||Number
2773274|NCT00717249|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Number of Subject Eyes|Participants||Number
2773869|NCT00712335|Secondary|Sputum Eosinophil Percentages|Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups|24 weeks|We will use ITT and PP protocols for analysis|||percentage of eosinophils||Standard Deviation|Mean
2773275|NCT00717236|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
2773276|NCT00717236|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
2773277|NCT00717236|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
2773278|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 28|Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis|||mg/L||95% Confidence Interval|Least Squares Mean
2773279|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis|||units on a scale||Standard Error|Least Squares Mean
2773280|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 28|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2773281|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 28|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2773282|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
2773283|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
2773284|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
2773285|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2773317|NCT00717093|Secondary|Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco|Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.|Week 26|ITT|||participants|||Number
2773286|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2773287|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2773288|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 28|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
2773289|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 28|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
2773290|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 28|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
2773291|NCT00717236|Secondary|European League Against Rheumatism (EULAR) Response at Week 12|EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773292|NCT00717236|Secondary|Time to Sustained American College of Rheumatology 20% (ACR20) Response|The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).|Baseline up to Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773293|NCT00717236|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
2773294|NCT00717236|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
2773295|NCT00717236|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
2773296|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 12|Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2773297|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2773298|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2773299|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2773300|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773301|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773302|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773303|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.|||units on a scale||Standard Deviation|Mean
2773304|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2773305|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2773306|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 12.|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773318|NCT00717093|Secondary|Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use|Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.|Week 9 through 12, Week 26|ITT|||participants|||Number
2773307|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 12|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2773308|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.|||percentage of subjects|||Number
2773309|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.|||percentage of subjects|||Number
2773310|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.|||percentage of subjects|||Number
2773311|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.|||percentage of subjects|||Number
2773312|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.|||percentage of subjects|||Number
2773313|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.|||percentage of subjects|||Number
2773314|NCT00717236|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of subjects|||Number
2773315|NCT00717197|Primary|Percentage of Participants With Progression-free Survival.|Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.|From date of first dose of study drug until month 6.|Per protocol|||percentage of participants with PFS6||95% Confidence Interval|Number
2773316|NCT00717093|Secondary|Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)|Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.|Week 12, Week 26|ITT|||participants|||Number
2773319|NCT00717093|Primary|Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco|"Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL."|Weeks 9 through 12|Intent to treat (ITT)|||participants|||Number
2773320|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals|Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to <480 msec, 480 to <500 msec, and >500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to < 60 msec, and change = ≥ 60 msec.|Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.|||subjects|||Number
2773321|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute|Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.|||bpm|||Number
2773322|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure|Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: <90 mmHg; and supine diastolic blood pressure, range: <50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication. BL: Baseline.|||subjects|||Number
2773323|NCT00717067|Secondary|Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD|CLdD: dialysate clearance before dialysis; measured in milliliters per minute.|Before dialysis|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mL/min||Standard Deviation|Geometric Mean
2773324|NCT00717067|Secondary|Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae|Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mg||Standard Deviation|Mean
2773325|NCT00717067|Secondary|Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function|Renal clearance (CLR) measured in milliliters per minute (mL/min).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mL/min||Standard Deviation|Geometric Mean
2773326|NCT00717067|Secondary|Half-life (t1/2)|Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||hour||Standard Deviation|Mean
2773327|NCT00717067|Secondary|Time of First Occurrence (Tmax)|Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||hours||Full Range|Median
2773328|NCT00717067|Secondary|Area Under the Time Curve From 0 to Infinity (AUCinf)|Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms * hour divided by millilters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.|||ng*hr/mL||Standard Deviation|Geometric Mean
2773329|NCT00717067|Secondary|Plasma Protein Binding|Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.|2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||percent free|||Number
2773330|NCT00717067|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||ng/mL||Standard Deviation|Geometric Mean
2773331|NCT00717067|Primary|AUCtau|AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms * hours divided by milliliters (ng.hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.|||ng*hr/mL||Standard Deviation|Geometric Mean
2773332|NCT00717067|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms * hour divided by milliliters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
2773333|NCT00717054|Secondary|Need for Antiemetic Medication||24 hours postoperatively||||participants|||Number
2773334|NCT00717054|Secondary|Total Vomiting||24 hours postoperatively||||participants|||Number
2773335|NCT00717054|Secondary|Number of Participants With Nausea and Vomiting in PACU||Postoperatively, up to 2 hours||||participants|||Number
2773336|NCT00717054|Primary|Number of Participants With Nausea and Vomiting||24 hours postoperatively||||participants|||Number
2773337|NCT00717041|Secondary|Depression and Cognitive Impairment at 2 Weeks|For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.|2 weeks||||participants||95% Confidence Interval|Number
2773338|NCT00717041|Primary|Participants With Anxiety by Generalized Anxiety Disorder - 7|Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.|2 hours||||participants|||Number
2773339|NCT00717041|Primary|Participants With Cognitive Impairment by Six Item Screener|Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect|2 hours||||participants|||Number
2773340|NCT00717041|Primary|Participants With Depression by Patient Health Questionnaire - 9|Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.|2 hours||||participants|||Number
2773341|NCT00716976|Secondary|Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)||4 weeks after the last dose of cisplatin|Data was and never will be collected||||||
2773342|NCT00716976|Secondary|Overall Survival (OS)|Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.|4 Years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.|||Percentage probability||95% Confidence Interval|Number
2773343|NCT00716976|Secondary|Event-Free Survival (EFS)|Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.|4 years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.|||Percentage probability||95% Confidence Interval|Number
2773344|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 8000 hz|Mean change in hearing threshold (post-pre) at 8000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 8000 hz; 42 patients in the observation arm had paired audiometry at 8000 hz.|||Decibels||Standard Deviation|Mean
2773345|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 4000 hz|Mean change in hearing threshold (post-pre) at 4000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 4000 hz; 47 patients in the observation arm had paired audiometry at 4000 hz.|||Decibels||Standard Deviation|Mean
2773346|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 2000 hz|Mean change in hearing threshold (post-pre) at 2000 hz|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 2000 hz; 47 patients in the observation arm had paired audiometry at 2000 hz.|||Decibels||Standard Deviation|Mean
2773347|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 1000 hz|Mean change in hearing threshold (post-pre) at 1000 hz.|4 weeks after last dose of cisplatin|37 eligible patients in the STS arm had paired audiometry at 1000 hz; 47 patients in the observation arm had paired audiometry at 1000 hz.|||Decibels||Standard Deviation|Mean
2773348|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 500 hz|Mean change in hearing threshold (post-pre) at 500 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 500 hz; 45 patients in the observation arm had paired audiometry at 500 hz.|||Decibels||Standard Deviation|Mean
2773349|NCT00716976|Primary|Incidence of Hearing Loss|Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.|4 weeks after last dose of cisplatin|55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.|||Patients|||Number
2773350|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||24 hours methacholine and sputum|||||||
2773351|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||sputum @ 7 hours|||||||
2773352|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).||Before inhalation both evaluations (0 hours)|||||||
2773353|NCT00716963|Primary|The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.||7 hours after challenge|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.|||percentage fall FEV1||Standard Deviation|Mean
2773354|NCT00716963|Primary|The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.||Before inhalation 3 hours|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.|||percentage fall FEV1||Standard Deviation|Mean
2773355|NCT00716859|Secondary|Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience|"An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as related to investigational product for reporting purposes."|Baseline through Week 12|Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication.|||Percentage of particpants|||Number
2773356|NCT00716859|Secondary|Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12|Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4, and Week 12|Evaluable participants in PP|||Percentage of participants||95% Confidence Interval|Number
2773357|NCT00716859|Secondary|Mean IOP at Week 12|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 12|Evaluable participants in PP|||mmHg||Standard Deviation|Mean
2773358|NCT00716859|Secondary|Mean IOP at Week 4|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 4|Evaluable participants in PP|||mmHg||Standard Deviation|Mean
2773359|NCT00716859|Secondary|Mean IOP at Week 1|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 1|PP|||mmHg||Standard Deviation|Mean
2773360|NCT00716859|Secondary|Mean IOP at Baseline|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline|PP|||mmHg||Standard Deviation|Mean
2773361|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 12 (Observed)|Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Evaluable participants in PP|||mmHg||Standard Error|Least Squares Mean
2773362|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 4|Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4|Evaluable participants in PP|||mmHg||Standard Error|Least Squares Mean
2773363|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 1|Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 1|PP|||mmHg||Standard Error|Least Squares Mean
2773364|NCT00716859|Primary|Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)|Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Per Protocol (PP) Population: participants with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF.|||mmHg||Standard Error|Least Squares Mean
2773365|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773366|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773367|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773368|NCT00716820|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773369|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773370|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773371|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773372|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773373|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773374|NCT00716820|Secondary|Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
2773375|NCT00716820|Secondary|Objective Response Rates by c-Kit Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
2773376|NCT00716820|Secondary|Objective Response Rates by KIT Expression Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
2773377|NCT00716820|Primary|Objective Response Rate|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
2773378|NCT00716820|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773379|NCT00716807|Primary|Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.||20 minute intervals for three hours.|Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.||||||
2773380|NCT00716742|Primary|Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year|Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).|Baseline, 1 Year|Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2773381|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773382|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773383|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773384|NCT00716625|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773385|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773386|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773387|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773388|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773389|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773390|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Pediatric Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773391|NCT00716625|Primary|Objective Response Rate|Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
2773392|NCT00716625|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
2773393|NCT00716482|Secondary|Interobserver Agreement of B Mode Ultrasound and SWE Features|614 benign and 144 malignant breast masses.|performed on the same day, after study completion|Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.|||kappa statistic||95% Confidence Interval|Number
2773394|NCT00716482|Secondary|Intraobserver Reliability of Quantitative SWE Measurements|614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.|performed on the same day, within 2 years from study start date|Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.|||correlation coefficient||95% Confidence Interval|Number
2773395|NCT00716482|Secondary|Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature|614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.|performed on the same day, within 2 years from study start date|Per protocol. One lesion was analyzed per participant.|||participants|||Number
2773396|NCT00716482|Primary|Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics|"Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.~Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.~Based on 939 lesions."|2 years|Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.|||participants|||Number
2773397|NCT00716456|Primary|The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks|To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)|At conclusion of study, up to 24 weeks||||mg/m2 of CETUXIMAB|||Number
2773398|NCT00716443|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds|Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds|Baseline to two days after injection of Restylane® into the nasolabial folds|Safety|||participants|||Number
2773399|NCT00716443|Secondary|"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"|"Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure?"|Day of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773400|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773401|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773402|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773403|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773404|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773405|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773406|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773407|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|Upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773408|NCT00716443|Secondary|"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"|"Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773409|NCT00716443|Secondary|"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773410|NCT00716443|Secondary|"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773411|NCT00716443|Secondary|"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2773412|NCT00716443|Primary|Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds|Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||centimeters||Standard Deviation|Mean
2773413|NCT00716417|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of afatinib in plasma at steady state|0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration|The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2773574|NCT00715741|Primary|Oxygen Requirement to Maintain SpO2>90%|Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.|45 min after emergence (tracheal extubation)||||liters per minute||Inter-Quartile Range|Median
2773414|NCT00716417|Secondary|Number of Patients With Objective Response|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).|Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
2773415|NCT00716417|Primary|Maximum Tolerated Dose (MTD) for Regimen A and Regimen B|The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||mg/m^2|||Number
2773416|NCT00716417|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
2773417|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.|||units on a scale||Standard Error|Least Squares Mean
2773418|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction."|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
2773419|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Healthy Participants|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Deviation|Mean
2773420|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
2773421|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Healthy Participants|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Deviation|Mean
2773422|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.|Baseline, 32 weeks|All healthy participants who had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
2773432|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.|The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|From Week 16 Up to Week 32|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2774139|NCT00711009|Secondary|Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2773423|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 Weeks|All healthy participants who had baseline and post-baseline WJ III measurements.|||units on a scale||Standard Deviation|Mean
2773424|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.|||units on a scale||Standard Error|Least Squares Mean
2773425|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction."|Baseline, 16 Weeks|All participants who had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
2773426|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Healthy Participants|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Deviation|Mean
2773427|NCT00716274|Secondary|Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
2773428|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Healthy Participants|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.|Baseline, 16 weeks|All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Deviation|Mean
2773429|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
2773430|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Deviation|Mean
2773431|NCT00716274|Secondary|Number of Participants With Adverse Events|Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|32 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2773433|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With Dyslexia|The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|From 16 Weeks Up to Week 32|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2773434|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.|The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|16 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2773435|NCT00716274|Secondary|The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia|The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|16 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2773436|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773437|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773438|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773439|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773440|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773672|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 10||||scale -3 to 3||Standard Deviation|Mean
2773441|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773442|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773443|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773444|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773445|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773446|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773673|NCT00714493|Secondary|Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26|Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26|Week 26||||percentage|||Number
2773447|NCT00716274|Secondary|Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773448|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773449|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773450|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773451|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773452|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2774140|NCT00711009|Secondary|Mean Change From Baseline in Cholesterol (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2773453|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to 32 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
2773454|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to Week 32||2019-05-31|05/2019||||
2773455|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to Week 32||2019-05-31|05/2019||||
2773456|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to 32 Weeks||2019-05-31|05/2019||||
2773457|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|From Week 16, Up to Week 32||2019-05-31|05/2019||||
2773458|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773459|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773460|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age."|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773461|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age."|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773515|NCT00715962|Secondary|Life-Space Assessment Score|"The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space levels range from within one's dwelling to beyond one's town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility."|4-6 weeks after baseline||||units on a scale||Standard Deviation|Mean
2773462|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773463|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773464|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773465|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773466|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773467|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773516|NCT00715962|Primary|Falls|Patients were asked daily during hospitalization to self-report any falls|18 months||||participants|||Number
2773517|NCT00715949|Secondary|To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.||study completion|||||||
2773674|NCT00714493|Secondary|Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase|Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase|Week 26||||percentage|||Number
2773468|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773469|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773470|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773471|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773472|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773473|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773528|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 3 years following primary vaccination|Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.|||Subjects|||Number
2774141|NCT00711009|Secondary|Mean Change From Baseline in Total Protein (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
2773474|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773475|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
2773476|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.|||units on a scale||Standard Error|Least Squares Mean
2773477|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
2773478|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
2773479|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
2773480|NCT00716274|Secondary|Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
2773481|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
2773482|NCT00716274|Secondary|Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
2773483|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
2773484|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
2773485|NCT00716274|Secondary|Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
2773486|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
2773487|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
2773488|NCT00716274|Secondary|Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
2773489|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a baseline and post-baseline WJ III measurement.|||units on a scale||Standard Error|Least Squares Mean
2773490|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a baseline and post-baseline WJ III measurement.|||units on a scale||Standard Error|Least Squares Mean
2773491|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a WJ III baseline and post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2773492|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, ADD possible but not likely. 40-54 equate to, ADD probable but not certain. 55-120 equate to, ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
2773493|NCT00716274|Secondary|Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Error|Least Squares Mean
2773494|NCT00716274|Primary|Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.|||units on a scale||Standard Error|Least Squares Mean
2773495|NCT00716274|Primary|Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Error|Least Squares Mean
2773496|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-05-31|05/2019||||
2773497|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With Attention Deficit Hyperactivity Disorder (ADHD) or ADHD + Dyslexia (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-05-31|05/2019||||
2773498|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-05-31|05/2019||||
2773499|NCT00716274|Primary|Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.|Baseline, 16 Weeks||2019-05-31|05/2019||||
2773500|NCT00716144|Secondary|PASI75 at Each Post Baseline Visit Except Visit 6|PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)|MITT population.|||Participants|||Number
2773501|NCT00716144|Secondary|Investigator's Global Assessment (IGA) at Each Post Baseline Visit|The IGA was used to assess the overall severity of a participant's plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant's plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.|Week 1 to Week 20 (Visit 3 to Visit 8)|MITT population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the MITT Population.|||Participants|||Number
2773502|NCT00716144|Secondary|PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit|PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 1 to Week 20 (Visit 3 to Visit 8)|MITT population.|||Participants|||Number
2773529|NCT00715910|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 1 year following primary vaccination|Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.|||Subjects|||Number
2774142|NCT00711009|Secondary|Mean Change From Baseline in Albumin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
2773503|NCT00716144|Primary|Psoriasis Area Severity Index (PASI)75 Success at Visit 6|PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 12 (Visit 6)|Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit).|||Participants|||Number
2773504|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h).|||mg*h/dL||Standard Error|Mean
2773505|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for FPG.|||mg/dL||Standard Error|Mean
2773506|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1.|||pmol*h/L||Standard Error|Mean
2773507|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG.|||mg/dL||Standard Error|Mean
2773508|NCT00716092|Secondary|Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).|Baseline and day 28|The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups.|||mg*h/dL||Standard Error|Mean
2773509|NCT00716092|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups|||mg/dL||Standard Error|Mean
2773510|NCT00716092|Primary|GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.|||pmol*h/L||Standard Error|Mean
2773511|NCT00716092|Primary|Weighted Mean Glucose (WMG) Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups|||mg/dL||Standard Error|Mean
2773512|NCT00716079|Secondary|Death at 90 Days||90 days||||participants|||Number
2773513|NCT00716079|Primary|A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)||90 days|In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group|||participants|||Number
2773514|NCT00715962|Primary|Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers|Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient's skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome.|During hospital stay|Only data from those recording days during which sensors were worn for at least 12 hours, defined as a valid day recording, were considered for final analysis. The average out of bed activity (standing or walking) duration over valid days of recording for each person was reported.|||minutes/day||Standard Deviation|Mean
2773518|NCT00715949|Primary|The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.|In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).|Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.|Analysis population includes only subjects who completed computerized neurocognitive tests. 120 subjects began the study, however 4 dropped out because they were unable to complete the first test and were not included in the final number of analyzed participants.|||participants|||Number
2773519|NCT00715910|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
2773520|NCT00715910|Secondary|Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)|Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
2773521|NCT00715910|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
2773522|NCT00715910|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
2773523|NCT00715910|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
2773524|NCT00715910|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|"Vaccine response was defined as:~For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination."|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Subjects|||Number
2773525|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2773526|NCT00715910|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Subjects|||Number
2773527|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 5 years following primary vaccination|Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.|||Subjects|||Number
2773722|NCT00714233|Secondary|Weight Loss in Lifestyle Intervention Group|In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI|baseline and 24 weeks|Analysis per protocol|||kg/m^2||Standard Deviation|Mean
2773530|NCT00715910|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2773531|NCT00715910|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values|The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773532|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773533|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773534|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
2773535|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773536|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773537|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773538|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773539|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773540|NCT00715910|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
2773541|NCT00715884|Secondary|Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.|31-360 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
2773542|NCT00715884|Secondary|Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.|0-30 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure.|||Percentage of participants|||Number
2773543|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)|"Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:~DEFINITE - Angiographic or pathologic confirmation;~PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent;~POSSIBLE - Any unexplained death > 30 days.~ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
2773544|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)|Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
2773545|NCT00715884|Secondary|Percentage of Participants Who Experienced Stroke|The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
2773546|NCT00715884|Secondary|Percentage of Participants Who Experienced Any Myocardial Infarction (MI)|Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
2773547|NCT00715884|Secondary|Percentage of Participants Who Died|Death incidences include both Cardiac and non-cardiac death.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
2773548|NCT00715884|Secondary|Percentage of Participants Who Experienced Bleeding Complications|"Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and Protocol definitions."|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
2773549|NCT00715884|Secondary|Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants who had diabetes and were followed up for 12 months.|||Percentage of participants|||Number
2773550|NCT00715884|Secondary|Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants with lesions of more than 1 vessel and were followed for 12 months|||Percentage of participants|||Number
2773551|NCT00715884|Secondary|Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)|MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
2773552|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Failure (TVF)|Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
2773553|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)|"TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
2773554|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)|"TLR is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA."|12 months post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
2773555|NCT00715884|Secondary|Percentage of Participants Who Achieved Procedure Success|Procedure success is defined as achievement of a final diameter stenosis of < 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.|At procedure during hospital stay|Intent to Treat|||Percentage of participants|||Number
2774143|NCT00711009|Secondary|Mean Change From Baseline in Bicarbonate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2773556|NCT00715884|Secondary|Percentage of Device Success - All CYPHER® Stents Included|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was <50%. Non-study CYPHER® Stents were also included.|At procedure|Intent to Treat population.|||Percentage of success|Participants||Number
2773557|NCT00715884|Secondary|Percentage of Device Success - Protocol Definition|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included.|At procedure|Intent to Treat population.|||Percentage of success|Participants||Number
2773558|NCT00715884|Secondary|Percentage of Lesion Success|Lesion success is defined as the attainment of < 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.|At procedure|ITT: All randomized participants regardless whether they received the intervention|||Percentage of success|Participants||Number
2773559|NCT00715884|Primary|Percentage of Participants Who Experienced Target Lesion Failure (TLF)|The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12-months post-procedure|Event-specific adjusted intent to treat (ITT) population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
2773560|NCT00715793|Secondary|1-year Overall Survival (OS) Rate|Percentage of patients alive at one year (number of patients alive / total number of evaluable (analyzed) patients).|12 months||||percentage of participants|||Number
2773561|NCT00715793|Secondary|Overall Survival (OS)|OS was defined as the time from study entry until the death or date of last contract.|Up to 42 months||||months||95% Confidence Interval|Median
2773562|NCT00715793|Secondary|6-month Progression-free Survival (PFS) Rate||6 months|Patients that either progressed or died by 6 months.|||percentage of participants|||Number
2773563|NCT00715793|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from study entry until the documented radiological or symptomatic progression. Per RECIST v1.0 criteria (assessed by MRI or CT): Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions.|Up to 42 months||||months||Full Range|Median
2773564|NCT00715793|Secondary|Disease Control Rate (DCR)|Using RECIST v1.0 criteria, disease control rate (DCR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD). Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months||||percentage of participants|||Number
2773565|NCT00715793|Primary|Recommended Phase 2 Dose (RP2D) of DAC + TMZ|Toxicity assessments used CTCAE v3.0. Two dose levels were explored in the phase I portion of the study. A modified 3 + 3 'up and down' design was used. Given the knowledge that DAC exhibits its epigenetic effects at 30-fold lower doses than at its maximum-tolerated dose (MTD), escalation of DAC to the MTD was not done.|Up to 26 months||||mg/kg DAC|||Number
2773566|NCT00715793|Primary|Overall Response Rate (ORR)|Using RECIST v1.0 criteria, overall response rate (ORR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD), multiplied by 100. Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months||||percentage of participants|||Number
2773567|NCT00715793|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT)|Dose-limiting toxicities (DLTs) were defined as grade 4 neutropenia or thrombocytopenia which lasts >7 days; grade 3 or 4 febrile neutropenia; grade 3 or greater non-hematological toxic effects.|Up to 26 months|Patients participating in the Phase 1 portion of the study that were treated on a standard “3+3” phase I dose-escalation design who were observed for unacceptable toxicities.|||percentage of participants|||Number
2773568|NCT00715754|Primary|Estimated Fetal Weight Percentile|Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation||||Percentile||Standard Deviation|Mean
2773569|NCT00715754|Primary|Fetal Abdominal Circumference|Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation||||cm||Standard Deviation|Mean
2773570|NCT00715754|Primary|Infant Adiposity at 24-72 Hours Following Birth|Adiposity as measured by air displacement plethysmography|24-72 hours following birth||||Percentage of total body weight||Full Range|Mean
2773571|NCT00715741|Secondary|SpO2 Postoperatively|SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.|24 hours after tracheal extubation||||percent saturation||Standard Deviation|Mean
2773572|NCT00715741|Secondary|"Arterial Oxygen Saturation by Pulse Oximetry (SpO2)"|SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%|45 min after tracheal extubation||||percent saturation||Standard Deviation|Mean
2773573|NCT00715741|Primary|Oxygen Requirement|amount of oxygen (LPM) required to maintain SpO2 >90%|24 hours after tracheal extubation||||liters per min||Inter-Quartile Range|Median
2773575|NCT00715728|Primary|Intraoperative Time Weighted Average Core Temperature|Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.|Until the end of surgery, up to 5 hour|Medical University of Vienna adults having major maxillary-facial reconstructive surgery expected to last about 5 h. Most had pectoral flap reconstructions after extensive cancer debridement. We did not study patients with Reynaud’s disease, thyroid dysfunction, insulin-dependent diabetes mellitus, or who were of ASA physical status > 3.|||degrees as measured in Celcius||Standard Error|Mean
2773576|NCT00715728|Primary|The Rate of Core Rewarming Over the Range From 35°C to 37°C.|The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.|Until the end of surgery, up to 5 hour||||degrees Celcius / hr||Standard Error|Mean
2773577|NCT00715676|Secondary|Number of Subjects With at Least 1 Treatment-emergent Adverse Event|To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.|1 year|The participants for this analysis included all randomized subjects who received a dose of study drug.|||Participants|||Number
2773578|NCT00715676|Secondary|Percent Change From Baseline in Serum Bone Markers at Week 26|Percent change from baseline at Week 26|Baseline and Week 26|Analyses were performed using subjects for whom both Baseline and Week 26 samples were available.|||Percent change||Standard Deviation|Mean
2773579|NCT00715676|Secondary|Change From Baseline in Serum Calcium Levels at Week 52|Change in serum calcium value (relative to baseline) at Week 52|Baseline and Week 52|This analysis was done for all subjects for whom both baseline and Week 52 data was available.|||mg/dL||Standard Deviation|Mean
2773580|NCT00715676|Secondary|Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52|Percent change in trochanter BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
2773581|NCT00715676|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52|Percent change in femoral neck BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
2773582|NCT00715676|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52|The percent change in hip BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent Change||Standard Deviation|Mean
2773583|NCT00715676|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|Percent change in lumbar spine BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
2773584|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 6||||days||Standard Deviation|Mean
2773585|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 3||||days||Standard Deviation|Mean
2773586|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 1||||days||Standard Deviation|Mean
2773587|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Baseline||||days||Standard Deviation|Mean
2773588|NCT00715624|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration for up to 125 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2773589|NCT00715624|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2773590|NCT00715624|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773591|NCT00715624|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2773592|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2773593|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2773594|NCT00715624|Secondary|Change From Baseline in Total Insulin Dose at Week 24|Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline total insulin dose assessment during on-treatment period.|||units per day||Standard Error|Least Squares Mean
2773595|NCT00715624|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2773596|NCT00715624|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773597|NCT00715624|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773598|NCT00715624|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773609|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse|Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||millivolts||Standard Deviation|Mean
2773599|NCT00715624|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. LOCF was used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2773600|NCT00715559|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|"The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is mild moderate or severe. The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of moderate or severe that also represented a change from a baseline-line pre-intervention SAFTEE assessment."|weekly, for 8 weeks|Study participants were assessed for side effects or adverse events with the SAFTEE at each study visit over the 8 week trial.|||symptoms||Standard Deviation|Mean
2773601|NCT00715559|Secondary|Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)|This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).|8 weeks||||scale score||Standard Deviation|Mean
2773602|NCT00715559|Secondary|Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)|"This set of scales measures global improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse."|8 weeks||||scale score||Standard Deviation|Mean
2773603|NCT00715559|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.|8 weeks|Mean MADRS score at end of treatment (LOCF) in 3 participants treated with cysteamine bitartrate.|||scale score||Standard Deviation|Mean
2773604|NCT00715520|Secondary|Aim 3: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.||||||
2773605|NCT00715520|Secondary|Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.||||||
2773606|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency|Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||g||Standard Deviation|Mean
2773607|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency|Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||millivolts||Standard Deviation|Mean
2773608|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse|Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||g||Standard Deviation|Mean
2773671|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 26||||scale -3 to 3||Standard Deviation|Mean
2773610|NCT00715520|Primary|Aim 1: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol. One subject was not included in the analysis due to corrupt data.|||g||Standard Deviation|Mean
2773611|NCT00715520|Primary|Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol for the placebo condition. One subject was not included in the analysis due to corrupt data.|||mV||Standard Error|Mean
2773612|NCT00715429|Secondary|Serum Calcium Level|Serum calcium was measured to detect any possible correlation between high dose of Vitamin D and hypercalcemia. Hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL.|Day 77||||mg/dL||Standard Deviation|Mean
2773613|NCT00715429|Primary|Change in the Nocturnal Leg Cramp Rate|"Difference in number of leg cramps per day during treatment period compared to baseline period.~Participants will undergo a 2-week diary run-in period to confirm cramp frequency. After a 2 week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the diary run-in until 1 week after the last dose of study drug/placebo."|baseline and 77 day||||cramps/day||Standard Deviation|Mean
2773614|NCT00715403|Primary|Difference From Baseline for Electrolytes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||mmol/L||Standard Error|Median
2773615|NCT00715403|Primary|Difference From Baseline for Coagulation Parameters|Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||sec||Standard Error|Median
2773616|NCT00715403|Primary|Difference From Baseline for Haematology and Differentials Parameters|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||10^9 /L||Standard Error|Median
2773617|NCT00715403|Primary|Difference From Baseline for Haemoglobin|Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From baseline until end of treatment, up to 991 days|Treated set.|||g/dL||Standard Error|Median
2773618|NCT00715403|Primary|Difference From Baseline for Bilirubin, Creatinine and Glucose|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||mg/dL||Standard Error|Median
2773619|NCT00715403|Primary|Difference From Baseline for Liver Enzymes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||U/L||Standard Error|Median
2773620|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5|All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
2773621|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4|All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
2773622|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3|All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
2773623|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2|All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
2773624|NCT00715403|Secondary|Progression Free Survival|"Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.~PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.~Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first."|First drug administration (in previous trial) until end of treatment, up to 1230 days|Treated set. Data for category|||percentage of participants|||Number
2773625|NCT00715403|Secondary|Confirmed Objective Response|Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
2773626|NCT00715403|Secondary|Clinical Benefit|Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
2773627|NCT00715403|Secondary|Unconfirmed Best Objective Response|Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
2773628|NCT00715403|Secondary|Unconfirmed Best Overall Response|"Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).~PD = Progressive disease."|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
2773629|NCT00715403|Secondary|Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)|Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29|Just before drug administration every 28±7 days after day 29|Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2773630|NCT00715403|Secondary|Clinically Relevant Abnormalities for Vital Signs|Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From baseline until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
2773631|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1|All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
2773632|NCT00715390|Primary|Arrhythmias During General Anesthesia in Children||July 1998 through July 2004||||participants|||Number
2773633|NCT00715299|Primary|The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.|Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.|Pre and post Treatment||||meters per second||Standard Deviation|Mean
2773634|NCT00715208|Secondary|Number of Patients Who Experienced at Least One Serious Adverse Event||From completion of informed consent through 30 days after the last dose of study drug|Safety Population: Treated patients|||participants|||Number
2773635|NCT00715208|Secondary|Duration of Response|"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria."|2 years|Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)|||Months||95% Confidence Interval|Median
2773636|NCT00715208|Secondary|Percentage of Participants With Progression-free Survival (PFS) at 1 Year|PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).|Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD|Safety population: Treated|||percentage of participants|||Number
2773637|NCT00715208|Secondary|Number of Participants With Overall Response (OR)|"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET."|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.|||participants|||Number
2773638|NCT00715208|Primary|Number of Patients With Complete Response (CR)|Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.|||participants|||Number
2773639|NCT00715117|Primary|Number of Patients Reporting Side Effects|Using adverse events and laboratory values Safety & toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.|8 weeks or 16 weeks|The Fisher Exact Test was used to evaluate the number of side effects reported between placebo and naltrexone groups. The Student T-test was used to evaluate the differences between the mena values of laboratory tests.|||participants|||Number
2773858|NCT00712530|Primary|Grade 3 Adverse Event Related to DermaVir Treatment|Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.|28 days||||participants|||Number
2773640|NCT00715117|Secondary|Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy|IMPACT III was a pediatric Crohn's specific quality of life survey used in this study. It examines five major categories influencing the quality of life in children with Crohn's disease including bowel symptoms, systemic symptoms, emotional well-being, social well-being, and body image perception. The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. So an increase in score denotes improved Quality of life.|16 weeks||||units on a scale||Standard Error|Mean
2773641|NCT00715117|Secondary|Pediatric Crohn's Disease Activity Index Score (PCDAI)|"Secondary outcome was efficacy on clinical activity. Mean pretreatment PCDAI scores in patients had moderate to severe disease activity at baseline were compared between those who received placebo for 8 weeks and those who received active experimental drug, naltrexone.~The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes remission. Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered response to therapy. The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease)."|Pretreatment and 8 weeks|The power calculations were performed using STPLAN version 4.1. The current investigation was designed as a pseudo-cross over study to increase the number of participants. In the proposed study, it was assumed that 80% would respond to naltrexone and that no more than 25% of the placebo.|||units on a scale||Standard Error|Mean
2773642|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.|||numbers of spots||Standard Error|Mean
2773643|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.|||number of spots||Standard Error|Mean
2773644|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.|The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.|||number of spots||Standard Error|Mean
2773645|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.|The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.|||numbers of spots||Standard Error|Mean
2773646|NCT00715104|Secondary|Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood|Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.|Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||numbers of spots||Standard Error|Mean
2773647|NCT00715104|Secondary|Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood|"Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.~This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150-7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells."|Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||numbers of spots||Standard Error|Mean
2773648|NCT00715104|Secondary|Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"|||cells/μm2||Standard Error|Mean
2773649|NCT00715104|Secondary|Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"|||cells/μm2||Standard Error|Mean
2773859|NCT00712348|Primary|Hemoglobin||Every 3 months from Baseline to Month 9||||g/dL||Standard Deviation|Mean
2773650|NCT00715104|Primary|Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||cells/μm2||Standard Error|Mean
2773651|NCT00715078|Primary|Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Baseline, Months 2, 4 and 6.|Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.|||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
2773652|NCT00715026|Secondary|Continued Assessment of Implant Survivorship and Incidences of Adverse Events.|A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.|At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years||||adverse events|||Number
2773653|NCT00715026|Primary|Harris Hip Score|The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.|Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years|Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.|||units on a scale||Standard Deviation|Mean
2773654|NCT00714948|Primary|To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin.||conclusion of the study|||||||
2773655|NCT00714870|Primary|Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)|"Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).~Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.~Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30."|one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later|To detect an effect with greater than or equal to 80% power at a 0.05 two sided significant level, we concluded we needed 22 participants completing each group, intervention and control|||units on a scale||Standard Deviation|Mean
2773656|NCT00714792|Primary|Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation|Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques.|within one week of enrollment|One overactive bladder subject had greater than 100,000 cfu in routine culture and their specimens were excluded from the analysis.|||participants|||Number
2773657|NCT00714753|Secondary|Freedom From Salvage Androgen Suppression Treatment|Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from salvage androgen suppression therapy.|From baseline to 5 years after registration|With only 5 patients, the study team deemed that this information would be unsuitable.||||||
2773658|NCT00714753|Secondary|Freedom From Biochemical and Clinical Failure|Freedom from biochemical and clinical failure, will be analyzed using Kaplan-Meier procedures. Estimates will be drawn from the Kaplan-Meier curves for the probability of freedom from biochemical and clinical failure.|From baseline to 5 years after registration|With only 5 patients, the study team deemed that the information would be unsuitable.||||||
2773659|NCT00714753|Secondary|Changes in Health-related Quality of Life Scores|A pretest-posttest design will be employed to detect changes in HRQOL scores over time. The HRQOL scores will be calculated per assessment, as appropriate. Each construct will be standardized to a range of 0-100 so that comparison across constructs is facilitated. Sets of difference scores will be computed: 1) differences between baseline and treatment completion (at 1 month post treatment follow up), and 2) differences between treatment completion and all post-treatment follow-up examinations for up to five years after finishing the protocol treatment (see Section 4.1 for specific HRQOL instruments to be completed at follow-up visits). The first analysis will allow for determination of the short-term impact of treatment on HRQOL, while the second will investigate the long-term treatment effect. Student's t-test methodology will be applied to the differences at end of treatment (1 month post treatment follow up) and at each follow-up.|From baseline to 5 years after registration|None of the enrolled patients were analyzed for this endpoint due to too few patients.||||||
2773860|NCT00712348|Other Pre-specified|Liver Volume|Liver volume measured by MRI|Baseline and 9 months|2 patients were MRI phobic|||mL||Standard Deviation|Mean
2773660|NCT00714753|Secondary|Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)|Patient preference for second treatment (group 1 or group 2) will be assessed using a Treatment Preference Questionnaire (Appendix IX) developed specifically for this study. Qualitative and quantitative analyses will be performed on patient responses to the questions posed after choosing their second treatment in an exploratory fashion.|From baseline until the end of the first treatment|None of the enrolled patients were analyzed for this endpoint due to too few patients.||||||
2773661|NCT00714753|Secondary|Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events|Dose-volume limitations for organs at risk will be analyzed byassociating GU or GI AEs (both rate and severity) with dosimetric parameters using simple correlational methods. These parameters will include (1) bladder V80, V60, V50, and Dmax; (2) penile bulb median dose; (3) rectum V80, V60, V50 and Dmax; and (4) urethra V120, V110, V100, and Dmax.|From baseline to 5 years after registration|No patients registered to a dose escalation Phase I group were analyzed for this endpoint. With only 5 patients, the study team deemed that the information would be unsuitable.||||||
2773662|NCT00714753|Primary|Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)|Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade >3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.|From baseline to 3 years after registration|All patients registered to a dose escalation Phase I group were analyzed for this endpoint. Only 1 patient was registered to the HDR+EBRT arm. Due to protected health information, listing only 1 patient's results is contraindicated.|||events|||Number
2773663|NCT00714714|Primary|Assessment of Facial Irritation and Cutaneous Effects|Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)|cumulative daily weekday scores for two weeks|One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).|||Ordinal data treated as interval||Standard Deviation|Mean
2773664|NCT00714688|Secondary|Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score|The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. It excludes patients for which a baseline value was missing.|||units on a scale||Standard Deviation|Mean
2773665|NCT00714688|Secondary|Clinical Global Impression-Change (CGI-C)|The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.It excludes patients for which either a baseline or end of treatment value was missing.|||units on a scale||Full Range|Median
2773666|NCT00714688|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment|The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.|||units on a scale||Full Range|Median
2773667|NCT00714688|Primary|Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)|The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.|||units on a scale||Standard Deviation|Mean
2773668|NCT00714571|Primary|Memory Test Accuracy on Trained Stimuli|Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test|Pre-training, post-training, 1 month|MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study|||Percent correct||Standard Deviation|Mean
2773669|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Weeks 26.|Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.|Week 26||||percentage|||Number
2773670|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Week 10|Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.|Week 10||||percentage|||Number
2773861|NCT00712348|Other Pre-specified|Spleen Volume|Spleen volume measured by MRI in mL|Baseline and 9 Months|25 patients had spleen volume measured by MRI, 2 were MRI phobic and 3 were splenectomized|||mL||Standard Deviation|Mean
2773862|NCT00712348|Other Pre-specified|Platelet Count||Every 3 months from Baseline to Month 9||||platelets/mm^3||Standard Deviation|Mean
2773675|NCT00714493|Primary|Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10|Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.|Week 10|The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified.|||Percentage|||Number
2773676|NCT00714415|Secondary|Investigator Assessment of Treatment Satisfaction of Participants|Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.|Baseline up to 8.7 years|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773677|NCT00714415|Secondary|Assessment of Treatment Handling by the Participants|Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773678|NCT00714415|Secondary|Assessment of Treatment Efficacy by the Participants|Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773679|NCT00714415|Secondary|Investigator Assessment of Treatment Handling of Participants|Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773680|NCT00714415|Secondary|Investigator Assessment of Treatment Efficacy of Participants|Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773681|NCT00714415|Secondary|Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work|Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.|Baseline, up to 8.7 years|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773682|NCT00714415|Secondary|Mean Total Number of Bleeding Episodes Per Year in Participants|Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.|Baseline until last visit (up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||bleeding episodes per year||Standard Deviation|Mean
2773683|NCT00714415|Secondary|Mean Total Number of Bleeding Episodes in Participants|Participants documented all bleeding episodes in a diary during the study.|Baseline until last visit (up to 8.7 years)|Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||bleeding episodes||Standard Deviation|Mean
2773684|NCT00714415|Primary|Participant Assessment of Treatment Tolerability|Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773685|NCT00714415|Primary|Investigator Assessment of Treatment Tolerability of Participants|Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.|End of study visit (any time up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2773686|NCT00714415|Primary|Number of Participants With Adverse Events (AEs) of Special Interest|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
2773687|NCT00714415|Primary|Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay|FIX inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
2773688|NCT00714415|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious. Relatedness to BeneFIX was assessed by the investigator.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
2773689|NCT00714415|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.|Baseline until last visit (up to 8.7 years)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.|||participants|||Number
2773690|NCT00714389|Primary|Maximal Flow Rate|Maximal uroflow of spontaneous subject voids|March 2008||||mL/sec||Standard Deviation|Mean
2773691|NCT00714389|Primary|Voided Volume|Volume of spontaneous void|March 2008||||mL||Standard Deviation|Mean
2773692|NCT00714311|Secondary|Borderline Symptomatology (DSM-IV Criteria)||1 month|||||||
2773693|NCT00714311|Secondary|Attachment Style and Reflective Function (Adult Attachment Interview, AAI)||1 year|||||||
2773694|NCT00714311|Secondary|Self-assessment of Psychopathology (BDI, STAI, BSI)||1 year|||||||
2773695|NCT00714311|Secondary|Number of Self-harming Acts||1 year|||||||
2773696|NCT00714311|Secondary|Level of Personality Organization (Structured Interview for Personality Organization, STIPO)||1 year|||||||
2773697|NCT00714311|Secondary|Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)||1 year|||||||
2773698|NCT00714311|Primary|Suicidality (Suicide Attempts)||1 year|||||||
2773699|NCT00714311|Primary|Drop-out|Did not finish one year of treatment.|1 year||||participants|||Number
2773700|NCT00714285|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
2773701|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination|During a 21 day (Days 0-20) follow-up period after vaccination-|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
2773702|NCT00714285|Secondary|Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).|MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
2773703|NCT00714285|Secondary|Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.|Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
2773704|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
2773705|NCT00714285|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.|Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
2773706|NCT00714285|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During a 7 day (Days 0-6) follow-up period after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
2773707|NCT00714285|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Days 0 and 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2773708|NCT00714285|Secondary|HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2773709|NCT00714285|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2773710|NCT00714285|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2773711|NCT00714259|Primary|Progression Free Survival Post Transplant|Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.|2 years post transplant||||participants|||Number
2773712|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|365 days post transplant||||participants|||Number
2773713|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|180 days post transplant||||participants|||Number
2773714|NCT00714259|Secondary|Composite Incidence of Acute and Chronic Graft Versus Host Disease||Up to 100 days post transplant.||||participants|||Number
2773715|NCT00714259|Secondary|Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant|Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.|Post transplant up to 100 days post transplant||||participant|||Number
2773716|NCT00714259|Secondary|Non-relapse Treatment Related Mortality|Death related to treatment without relapse within 100 days after transplant|Within 100 days post transplant||||participants|||Number
2773717|NCT00714259|Primary|Progressive Free Survival Post Transplant|subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|100 days post transplant||||participants|||Number
2773718|NCT00714233|Secondary|Change in Fasting Glucose|Change in fasting glucose concentration by treatment group pre to post intervention|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
2773719|NCT00714233|Secondary|Triglyceride Concentration by Treatment Group|Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
2773720|NCT00714233|Secondary|Change in SHBG|Measurement of SHBG by treatment group pre and post intervention|baseline and 24 weeks||||ratio||Standard Deviation|Mean
2773721|NCT00714233|Secondary|Change in Free Androgen Index (FAI)|Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.|baseline and 24 weeks|analysis per protocol|||total T/SHBG||Standard Deviation|Mean
2773723|NCT00714233|Primary|Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification|The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY|24 week|Analysis was a description of number of recruited subjects.|||participants|||Number
2773724|NCT00714168|Secondary|Body Composition|Change in Percent Body Fat from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis|||percent body fat||95% Confidence Interval|Least Squares Mean
2773725|NCT00714168|Secondary|Cardiovascular Fitness|Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.|||minutes||95% Confidence Interval|Least Squares Mean
2773726|NCT00714168|Secondary|Energy Intake|Change in Energy Intake from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects analyzed.|||kcal/day||95% Confidence Interval|Least Squares Mean
2773727|NCT00714168|Secondary|Physical Activity|Change in Physical Activity from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.|||kcal/week||95% Confidence Interval|Least Squares Mean
2773728|NCT00714168|Primary|Weight Loss|Change in Weight from Baseline|Measured at Month 18|We used an intention-to-treat analysis with all randomized subjects included in the analysis.|||kg||95% Confidence Interval|Least Squares Mean
2773729|NCT00714051|Primary|Number of Participants Who Fell on a Tripping Test|Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.|4 weeks||||participants|||Number
2773730|NCT00713830|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 120 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The one patient in the placebo group who received Lixisenatide was analyzed in the Lixisenatide group|||participants|||Number
2773731|NCT00713830|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2773732|NCT00713830|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2773733|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2773734|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2773750|NCT00713817|Secondary|Number of Subjects Who Failed Treatment at the End of the Treatment Period|"Treatment failure was defined as follows:~A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:~B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline."|Day 7 to time of last dose|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
2773735|NCT00713830|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|The fasting C-peptide and the 2-hour postprandial C-peptide blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. here. number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||nmol/L||Standard Error|Least Squares Mean
2773736|NCT00713830|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|The fasting proinsulin-to-insulin ratio and 2-hour postprandial proinsulin-to-insulin ratio were measured during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data imputed using LOCF. Number of patients analyzed=patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n'= patients with baseline and at least 1 post-baseline assessment for the specific category.|||ratio||Standard Error|Least Squares Mean
2773737|NCT00713830|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|The fasting Proinsulin and the 2-hour postprandial Proinsulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
2773738|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24|The fasting plasma insulin and the 2-hour postprandial plasma insulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
2773739|NCT00713830|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|The fasting glucagon and the 2-hour postprandial glucagon blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ng/L||Standard Error|Least Squares Mean
2773740|NCT00713830|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773751|NCT00713817|Secondary|Change From Baseline Neuropathic Pain Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2773863|NCT00712335|Secondary|Sputum RANTES Levels|Week 24 sputum RANTES levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.|||pg/ml||Standard Deviation|Mean
2773741|NCT00713830|Secondary|Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta blood samples were drawn during a standardized meal challenge test (performed in selected sites). HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
2773742|NCT00713830|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2773743|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773744|NCT00713830|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG blood sample was drawn 2 hours after start of a standardized meal (standardized meal challenge test performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773745|NCT00713830|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2773746|NCT00713817|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study is presented.|Day 0 -35|The safety analysis set comprised all subjects who received at least one dose of study medication.|||participants|||Number
2773747|NCT00713817|Secondary|Subject Global Impression of Change at the End of Treatment|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your nerve pain since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. The number of subjects wo reported an improvement is presented."|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
2773748|NCT00713817|Secondary|Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2773749|NCT00713817|Secondary|Number of Subjects With More Than a 20% Loss of Response at the End of Treatment|The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
2773864|NCT00712335|Secondary|Sputum Eotaxin Levels|Week 24 sputum eotaxin levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.|||pg/ml||Standard Deviation|Mean
2773752|NCT00713817|Primary|Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2773753|NCT00713700|Primary|The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.|The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.|180 days|Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.|||percentage of participants||95% Confidence Interval|Number
2773754|NCT00713700|Primary|The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.|"The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure~SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event."|180 days|Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.|||percentage of participants||95% Confidence Interval|Number
2773755|NCT00713661|Secondary|The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.|Day of surgery|Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.|||participants|||Number
2773756|NCT00713661|Primary|The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.|Day of surgery|"ITT + Safety Analysis Set.~All applications recorded as “not feasible” by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis."|||participants|||Number
2773757|NCT00713648|Secondary|Number of Subjects With rFXIII Antibody Development|Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - Subjects who received at least one dose of trial product.|||participants|||Number
2773758|NCT00713648|Secondary|Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.|||U/kg||Standard Deviation|Mean
2773759|NCT00713648|Secondary|Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.|||percentage (%) of subjects|||Number
2773760|NCT00713648|Primary|Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period|It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product.|||bleeding episodes per subject per year||Full Range|Mean
2773761|NCT00713609|Secondary|Proportion of Participants With an ISGA Score of 0 or 1 at Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Week 12|ITT Analysis Set|||Percentage of participants|||Number
2773762|NCT00713609|Secondary|Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|ITT Analysis Set|||Percent change||Standard Deviation|Mean
2773763|NCT00713609|Primary|Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Baseline and up to Week 12|ITT Analysis Set|||Percentage of participants|||Number
2773764|NCT00713609|Primary|Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.|||Lesion count||Standard Deviation|Mean
2773765|NCT00713596|Primary|Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity|"ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied).~NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem).~Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose"|6 months post operative|||||||
2773766|NCT00713596|Secondary|Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire|At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons. The photos will be presented to the evaluators in a completely random fashion at a single session. These photos will be graded at that time using the same questionnaire used by the operating surgeon. The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.|6 months postoperative|||||||
2773767|NCT00713583|Primary|Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES)|The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure.|12 weeks of treatment||||cocaine-negative urines||Standard Deviation|Mean
2773768|NCT00713544|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability.|Baseline to 12 Weeks||||Units on a scale||Standard Deviation|Mean
2773769|NCT00713544|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28)|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 12 Weeks' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms.|Baseline to 12 Weeks||||Units on a scale||Standard Deviation|Mean
2773770|NCT00713544|Secondary|American College of Rheumatology 70 Response (ACR70)|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment.|12 weeks||||Participants|||Number
2773865|NCT00712335|Secondary|Sputum IFN-gamma/IL-5 Ratios|Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.|24 weeks|ITT and PP were used for analysis.|||ratio||Standard Deviation|Mean
2773771|NCT00713544|Secondary|American College of Rheumatology 50 Response (ACR50)|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment.|12 weeks||||Participants|||Number
2773772|NCT00713544|Primary|American College of Rheumatology 20 Response (ACR20)|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment.|12 weeks||||Participants|||Number
2773773|NCT00713479|Secondary|Depression|Using the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression.|Daily||||units on a scale|Total BDI|Standard Deviation|Mean
2773774|NCT00713479|Primary|Heart Rate|Heart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals||||bpm|Time Points|Standard Deviation|Mean
2773775|NCT00713479|Primary|Diastolic Blood Pressure|Diastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals||||mm Hg|Time Points|Standard Deviation|Mean
2773776|NCT00713479|Primary|Systolic Blood Pressure|Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|Per protocol|||mm Hg|time points|Standard Deviation|Mean
2773777|NCT00713349|Primary|Complete Wound Closure|Each subject acting as their own control|21 Days||||days||Standard Deviation|Mean
2773778|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)|"The patient was asked on a scale of '0 to 10' please indicate the average level of your intoxication due to medications over the last 24 hours (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773779|NCT00713323|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).|42 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||participants|||Number
2773780|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773781|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773782|NCT00713323|Secondary|Subject Global Impression of Change|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported."|week 38|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||participants|||Number
2773783|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773784|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773785|NCT00713323|Primary|Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773786|NCT00713310|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and Week 6|mITT subjects who were randomized & took at least one dose of study medication|||% participants with treatment success|||Number
2773787|NCT00713310|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and 6 weeks|miTT includes subjects who were randomized and took at least one dose of study medication|||% participants with treatment success|||Number
2773788|NCT00713258|Secondary|Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment|"Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person's functional level is restricted by pain.~ODI scores from 0 = no disability to 100 = maximum disability.~Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status."|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."|||scores on a scale||Standard Deviation|Mean
2773789|NCT00713258|Primary|Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.|"The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = no pain and 10 = unendurable pain)."|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."|||points on a scale||Standard Deviation|Mean
2773790|NCT00713219|Primary|Overall Progression-Free Survival (PFS).|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|conclusion of the study||||Days||Full Range|Mean
2773791|NCT00713206|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis|3 year|Number of participants used in analysis selected as per protocol|||participants|Number of implants analyzed||Number
2773792|NCT00712985|Primary|Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months|17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.|One year||||participants|||Number
2773793|NCT00712959|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose|"Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2773794|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
2773795|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
2773796|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:~≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or~≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or~≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ."|Day 30 post-vaccination|Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.|||Percentage of Particpants|||Number
2773854|NCT00712530|Secondary|Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline|HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.|28 days||||PHPC count||Standard Deviation|Mean
2773797|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Anti-diphtheria or anti-tetanus booster responses were defined as:~Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response."|Day 30 post-vaccination|Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.|||Percentage of Participants|||Number
2773798|NCT00712959|Primary|Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
2773799|NCT00712959|Primary|Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose|"Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL."|Day 0 (pre-vaccination) and 30 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.|||Percentage of Participants|||Number
2773800|NCT00712933|Primary|Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit|The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
2773801|NCT00712933|Primary|Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit|Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.|Up to 9 years|MITT Population|||Participants|||Number
2773802|NCT00712933|Primary|Number of Participants With IgG Values Below the Lower Limit of Normal by Year|Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
2773803|NCT00712933|Primary|Number of Participants With Immunogenic Response by Year|Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
2773804|NCT00712933|Primary|Change From Baseline in Immunoglobulin G (IgG) Levels|Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||g/L||Standard Deviation|Mean
2773805|NCT00712933|Primary|Change From Baseline in Bilirubin (Bili) Levels|Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||µmol/L||Standard Deviation|Mean
2773855|NCT00712530|Secondary|Number of Subjects Having More Than 50 Copies/mL HIV RNA||28 days||||participants|||Number
2773856|NCT00712530|Secondary|Number of Subjects With Detectable Anti-ds Antibody and ANA||28 days||||participants|||Number
2773806|NCT00712933|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels|Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||International Units/liter (IU/L)||Standard Deviation|Mean
2773807|NCT00712933|Primary|Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2773808|NCT00712933|Primary|Change From Baseline in BUN and Glucose at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||mmol/L||Standard Deviation|Mean
2773809|NCT00712933|Primary|Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Grams per liter (g/L)||Standard Deviation|Mean
2773810|NCT00712933|Primary|Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to 9 years|MITT Population|||Ratio||Standard Deviation|Mean
2773811|NCT00712933|Primary|Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points|Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2773812|NCT00712933|Primary|Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Trillions cells per liter||Standard Deviation|Mean
2773857|NCT00712530|Secondary|CD4+ T Cell Counts/mm3||28 days||||CD4+ T cell counts/mm3||Standard Deviation|Mean
2773813|NCT00712933|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Percentage of blood by volume||Standard Deviation|Mean
2773814|NCT00712933|Primary|Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Gram per liter (g/L)||Standard Deviation|Mean
2773815|NCT00712933|Primary|Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Billion cells per liter||Standard Deviation|Mean
2773816|NCT00712933|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point|Baseline and up to 9 years|MITT Population|||Seconds||Standard Deviation|Mean
2773817|NCT00712933|Primary|SAE Rates by SOC During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to 9 years|MITT Population|||Adverse events per 100 participant years|Subject years||Number
2773818|NCT00712933|Primary|Number of Participants With Serious Adverse Events (SAE)|An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.|Up to 9 years|MITT Population|||Participants|||Number
2773819|NCT00712933|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to 9 years|MITT Population|||Adverse events per 100 participant years|Subject years||Number
2773820|NCT00712933|Primary|Number of Participants With Adverse Events (AE)|An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.|Up to 9 years|MITT Population|||Participants|||Number
2773821|NCT00712920|Secondary|Change From Baseline on Direct Visual Nasal Exams and 28 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 28 days|ITT|||Participants|||Number
2773866|NCT00712335|Secondary|Sputum GM-CSF Levels|Week 24 sputum GM-CSF levels in active treatment groups were measured.|24 weeks|We will use ITT and PP for analysis|||pg/ml||Standard Deviation|Mean
2773822|NCT00712920|Secondary|Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days|A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.|baseline and 28 Days|ITT|||Units on a Scale||Standard Deviation|Least Squares Mean
2773823|NCT00712920|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days|Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.|baseline and 28 days|ITT|||Scores on a Scale||Standard Deviation|Least Squares Mean
2773824|NCT00712920|Secondary|Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day."|baseline and 28 days|ITT|||Scores on a Scale||Standard Deviation|Least Squares Mean
2773825|NCT00712920|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.|"Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day~Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 28 days|ITT|||Scores on a Scale|||Number
2773826|NCT00712725|Secondary|Sustained Pain Freedom (SPF)|Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.|2-24 hours postdose|Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.|||Participants|||Number
2773827|NCT00712725|Secondary|Absence of Nausea|Absence of nausea at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
2773828|NCT00712725|Secondary|Absence of Phonophobia|Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
2773829|NCT00712725|Secondary|Absence of Photophobia|Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
2773830|NCT00712725|Secondary|Pain Relief (PR)|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
2773831|NCT00712725|Primary|Pain Freedom (PF)|"Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
2773832|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2773833|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2773834|NCT00712673|Secondary|Percentage of Patients Requiring Rescue Therapy During the Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2773835|NCT00712673|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2773836|NCT00712673|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2773837|NCT00712673|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
2773838|NCT00712673|Secondary|Change From Baseline in Adiponectin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline adiponectin assessment during on-treatment period.|||mcg/mL||Standard Error|Least Squares Mean
2773839|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.|||ng/L||Standard Error|Least Squares Mean
2773840|NCT00712673|Secondary|Change From Baseline in Fasting Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.|||ng/L||Standard Error|Least Squares Mean
2773841|NCT00712673|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal teat. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773842|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.|||nmol/L||Standard Error|Least Squares Mean
2773843|NCT00712673|Secondary|Change From Baseline in Fasting C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.|||nmol/L||Standard Error|Least Squares Mean
2773844|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
2773845|NCT00712673|Secondary|Change From Baseline in Fasting Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
2773846|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PPI assessment during on-treatment period|||pmol/L||Standard Error|Least Squares Mean
2773847|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
2773848|NCT00712673|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2773849|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773850|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2773851|NCT00712673|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2773852|NCT00712543|Primary|Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.||14 days||||participants|||Number
2773853|NCT00712530|Other Pre-specified|Change in HIV-specific Memory T Cell Responses at Week 48|"HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.~Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available"|48 weeks||||PHPC count||Standard Deviation|Mean
2773867|NCT00712335|Secondary|Sputum IL-8 Levels|Week 24 sputum IL-8 levels in active treatment groups|24 weeks|We will ITT and PP protocols for analysis|||pg/ml||Standard Deviation|Mean
2773870|NCT00712270|Secondary|Assessment of Pretreatment and Posttreatment Psychiatric Rating Scales to Include PANSS and CGI|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.|7 visits over 16 weeks|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.||||||
2773871|NCT00712270|Primary|QTc Measurement|Information regarding the Outcome Measure being a Primary or Secondary, is unavailable.||Limited data only available for 8 of 21 patients|||milliseconds||Full Range|Mean
2773872|NCT00712270|Primary|Pre and Post Treatment PET and MRI Imaging||At baseline and 16 weeks|Study was terminated back in 2009 with limited data available. Randomization is not known. Only 7 subjects completed study. Data for this objective is not available.||||||
2773873|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
2773874|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
2773875|NCT00712244|Secondary|Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
2773876|NCT00712244|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg.|1 day after surgery|This data was collected on all subjects attending the visit one day after surgery with the exception of 3 DisCoVisc subjects, 4 DuoVisc subjects, 2 Healon5 subjects, and 1 AmVisc Plus subject.|||mmHg||Standard Deviation|Mean
2773877|NCT00712244|Secondary|Aqueous Signs - Aqueous Cells|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of participants|||Number
2773878|NCT00712244|Secondary|Aqueous Signs - Aqueous Flare|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.|1 Day after Surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of participants|||Number
2773879|NCT00712244|Secondary|Aqueous Signs - Corneal Edema|Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of Participants|||Number
2773880|NCT00712244|Secondary|Percent Gain in Corneal Thickness.|Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.|1 week and month after surgery|Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.|||Percent Gain||Standard Deviation|Mean
2773881|NCT00712244|Primary|Corneal Endothelial Cell Loss|Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.|1 month after surgery||||Percent Change||Standard Deviation|Mean
2773882|NCT00712179|Primary|Diagnostic|"The electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores."|During sessions- 1 day measurement|Individuals with chronic stroke.|||Z-score||Standard Error|Mean
2773883|NCT00712166|Secondary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF method was used.|||Percent change from baseline||Standard Error|Least Squares Mean
2773908|NCT00711971|Other Pre-specified|Gestational Age at Delivery (Weeks)||delivery date was assessed by medical record review between 1 day and 8 weeks after delivery|Gestational age is measured based on the pregnancy not the neonates, therefore although there were 40 babies born to the 39 mothers randomized to the EPA-rich fish oil, it is proper to consider the participants analyzed to be the 39 participating mothers. This is clarified still further by identifying the units appropriately as pregnancies.|||weeks|pregnancies|Standard Deviation|Mean
2773884|NCT00712166|Secondary|Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28|Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
2773885|NCT00712166|Other Pre-specified|The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)|Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo).|||µg/mL|||Number
2773886|NCT00712166|Other Pre-specified|Number of Participants Testing Positive for Other Respiratory Pathogens|Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Participants|||Number
2773887|NCT00712166|Secondary|Number of Participants Hospitalized During Study|Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Study participants|||Number
2773888|NCT00712166|Secondary|Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study|The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher's Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Participants|||Number
2773889|NCT00712166|Secondary|Change From Baseline in CFQ-R Physical Functioning Domain Score|The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
2773890|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 42|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 42|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
2773891|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 14|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 14|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
2773941|NCT00711646|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented.|Day 0-52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
2773892|NCT00712166|Primary|Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis on intent-to-treat (ITT) population (received at least part of 1 dose of AZLI/placebo). Missing baseline data not imputed. Missing post-baseline data imputed with worst-case value for participants who withdrew due to an adverse event (AE)/study drug intolerance. Imputation for other missing data was last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2773893|NCT00712075|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)||||units on a scale||Standard Deviation|Mean
2773894|NCT00712075|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)||||units on a scale||Standard Deviation|Mean
2773895|NCT00712075|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent a higher level of functioning.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|Due to incomplete ILSS data for one participant in the CBSST group, 25 of 26 participants were included in the analyses for this measure.|||units on a scale||Standard Deviation|Mean
2773896|NCT00712010|Primary|Calculation of the Area Under Curve Over Baseline for Plasma Insulin|The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes from baseline||||nmole/L*min||Standard Error|Mean
2773897|NCT00712010|Secondary|Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids||180 minutes|||||||
2773898|NCT00712010|Primary|Post-prandial Plasma Responses of Glucose Concentrations|The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes|23 subjects were investigated for AUC of glucose calculations|||mmole/L*min||Standard Error|Mean
2773899|NCT00711997|Primary|Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819|If 2 patients in any cohort experience DLTs, then the next lower dose will be considered the MTD if there is a lower dose cohort. A DLT is defined as grade 3 or greater toxicity judged to be at least possibly related to the investigational products.|Week 4|All participants had to receive all 4 scheduled treatments and completed the Week 4 assessment|||participants|||Number
2773900|NCT00711997|Secondary|Tumor Resectability|The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.|5 to 6 weeks||||participants|||Number
2773901|NCT00711997|Secondary|Tumor Response|Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment|4 weeks||||participants|||Number
2773902|NCT00711971|Other Pre-specified|Cord Arterial pH|Arterial blood gas analysis of umbilical cord blood|Immediately after birth (collected within the first hour after delivery)|Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants.|||pH||Standard Deviation|Mean
2773903|NCT00711971|Other Pre-specified|Five Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.|5 minutes after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.|||units on a scale||Standard Deviation|Mean
2773904|NCT00711971|Other Pre-specified|One Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.|1 minute after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.|||units on a scale||Standard Deviation|Mean
2773905|NCT00711971|Other Pre-specified|NICU (Neonatal Intensive Care Unit) Admissions|Admission to the NICU|6 weeks post delivery|One set of twins in group A|||Participants|||Count of Participants
2773906|NCT00711971|Other Pre-specified|Neonatal Birthweight|Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age.|immediately after birth|Data is provided for all babies on whom delivery weights were available with a set of twins in EPA rich fish oil arm and a delivery elsewhere for whom no birth weight was available for one baby from a mother in the Soy oil placebo arm. Thus there is 1 more participant than mothers participating in the EPA-rich arm and one less in the soy oil arm.|||grams||Standard Deviation|Mean
2773907|NCT00711971|Other Pre-specified|Estimated Blood Loss (ml)||Within 24 hours after delivery||||mL||Standard Deviation|Mean
2773909|NCT00711971|Other Pre-specified|Maternal Outcomes|While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.|visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery|"Gestational hypertension and diabetes were self-reported for all participants so her data is included for those two rows.~One woman in the soy placebo arm delivered out of the geographic area, so documentation of delivery outcome is unavailable for analysis."|||participants|||Number
2773910|NCT00711971|Primary|Beck Depression Inventory|The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)|6 - 8 weeks postpartum|Per protocol analysis is reported here.|||units on a scale||Standard Deviation|Mean
2773911|NCT00711958|Primary|Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia|Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.|5-12 weeks|Intention-to-treat population: patients with post baseline Hemoglobin value available|||Participants|||Count of Participants
2773912|NCT00711880|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
2773913|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment|"Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'.~A summary of the number and percentage of subjects"|Day 0 - 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
2773914|NCT00711880|Secondary|Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment|Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled 'no intoxication' and 100 equalled 'extreme intoxication'. A negative value indicates an improvement in intoxication score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773915|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment|Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The number of subjects who reported an improvement is presented.|Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
2773916|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||number of words||Standard Deviation|Mean
2773917|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||percentage of correct answers||Standard Deviation|Mean
2773918|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773919|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773967|NCT00711555|Secondary|Complete Protection|defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
2773968|NCT00711555|Primary|Complete Response|defined as a no emetic episodes and no use of rescue therapy|cycle 1, day 1||||%|||Number
2773920|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773921|NCT00711880|Secondary|Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment|The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773922|NCT00711880|Secondary|Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment|The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject's pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773923|NCT00711880|Secondary|Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773924|NCT00711880|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment|The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject's chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals 'no disability') to 10 (which equals 'total disability'). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773925|NCT00711880|Secondary|Change From Baseline in Mean Sleep Quality at the End of Treatment|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773926|NCT00711880|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773927|NCT00711880|Primary|Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)|"The neuropathic pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline."|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2773928|NCT00711867|Primary|Sublingual Temperature.||Within 10 minutes of arrival in PACU|Per protocol.|||C||Standard Deviation|Mean
2773929|NCT00711828|Secondary|Adverse Events|Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.|up to 12 cycles (28 days per cycle) of treatment||||participants|||Number
2774099|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2773930|NCT00711828|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
2773931|NCT00711828|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years from registration|Thirteen patients achieved a CR or a PR and are included in this analysis.|||months||95% Confidence Interval|Median
2773932|NCT00711828|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
2773933|NCT00711828|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
2773934|NCT00711828|Primary|Proportion of Responses (Complete Response or Partial Response)|A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.|up to 12 cycles||||percentage of participants||95% Confidence Interval|Number
2773935|NCT00711802|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])|"Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:~Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion."|Predose and 5 timepoints according to age group (up to 12 hours postdose)|Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.|||microgram*hour per milliliter (μg*hr/mL)||Standard Deviation|Mean
2773936|NCT00711802|Secondary|Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit|"The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as Success or Failure by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered Success by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of Failure was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was Failure. If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was Unable to evaluate."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.|||percentage of participants|||Number
2773937|NCT00711802|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.|||percentage of participants|||Number
2773938|NCT00711711|Primary|Lower Limb Volume Percentage Difference Operated/Healthy|The limb volume was evaluated for each limb using circumferential tape measurements at 4 cm intervals. Then the tape measurementy were converted into limb volume using the validated truncated-cone method, and the percentage difference between the operated and the healthy limb was calculated.|presurgery, and 2 days, 7 days and 3 months after surgery|"At day 7, 3 patients lost at follow up in the control group and 1 in the treatment group.~At 3 months, 3 more patients lost at follow up in the control group."|||percentage difference between limbs||Standard Deviation|Mean
2773939|NCT00711711|Primary|Bioimpedance Percentage Difference Healthy/Operated|The bioimpedance, i.e. a measurement in ohms of the opposition to current flow between electrodes was evaluated for each limb. Then the bioimpedance percentage difference between operated and healthy limb was calculated.|presurgery, 2 days, 7 days and 3 months post surgery|"At day 7, 3 patients lost at follow up in the control group and 1 in the treatment group.~At 3 months, 3 more patients lost at follow up in the control group."|||percentage difference between limbs||Standard Deviation|Mean
2773940|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Legs|Ankle dorsiflexion, knee extension and hip flexion were assessed and scored to give a maximum of 100%. The Motricity Index score (scale 1-100) was recorded for limbs that had an associated Ashworth Scale score, which was greater than or equal to two at baseline.|Day 7 and Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773942|NCT00711646|Secondary|Patient's Global Impression of Change in Condition at the End of Treatment|"A 7-point Likert-type scale was used, with the question: 'Please assess the change in your condition since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported."|Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
2773943|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Arms|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. The total arm score was the addition of the score for the 3 arm movements. One point was then added to give a maximum score of 100; minimum was 1 point. Where both arms were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition..|Day 7 and 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773944|NCT00711646|Secondary|Change From Baseline in Mean Spasm Frequency Score at the End of Treatment|Each day subjects recorded in their diary the frequency of their spasms using the following scoring system: 0 = no spasms, 1 = one or fewer spasms per day, 2 = between one and five spasms per day, 3 = six to nine spasms per day, 4 = ten or more spasms per day or continuous contraction. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy.|Days 0 - 52||||units on a scale||Standard Deviation|Mean
2773945|NCT00711646|Secondary|Change From Baseline in Mean Ashworth Scale Score at the End of Treatment|The mean Ashworth Scale score across muscle groups was calculated using only those muscle groups with a score of greater than or equal to two at baseline. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Days 0 - 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773946|NCT00711646|Primary|Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.|"The spasticity Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your average spasticity in the last 24 hours where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline."|0-52 days|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2773947|NCT00711594|Secondary|Phase I Step: Cmax,Cmax,ss of BIBW 2992 After Multiple Oral Administration||Just before start of the treatment to Course 4 Visit 4R2|"The “treated set” of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.Some samples were excluded from the evaluation because these were taken outside the allowed time-windows.~Number of analyzed patients of BIBW 50mg cohort for Cmax,ss: 5"|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2773948|NCT00711594|Secondary|Phase II Step: Summary of EGFR Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
2773949|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 15|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 15|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2773950|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 1|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 1|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2773951|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course1 Day 15|"Outcome data show the geometric mean (gMean) of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|Course 1 Day 15|Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification. No patient was treated with 30 mg during the Course 1.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2773952|NCT00711594|Secondary|Phase II Step: Maximum CTC Grade During the Trial for Laboratory Parameters, Among Patients Who Experienced an Increase in CTC Grade From Baseline|outcome data show the number of patients for the maximum CTC grade during the trial for laboratory parameters, among patients who experienced an increase in CTC Grade|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.~For activated partial thromboplastin time (APTT), N = 59 For Prothrombin Time and International Normalized Ratio (PT-INR), N = 61"|||participants|||Number
2773953|NCT00711594|Secondary|Phase II Step: Safety of BIBW 2992 as Indicated by Intensity and Incidence of Adverse Events, Graded According to CTCAE|outcome data show the number of patients with Adverse events (AE) by intensity and incidence of adverse events, graded according to CTCAE.|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
2773954|NCT00711594|Secondary|Phase II Step: Overall Survival (OS)|OS was defined as the duration of time from the start of treatment to the time of death.|from start of treatment until end of follow up, up to 53 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Months||Inter-Quartile Range|Median
2773955|NCT00711594|Secondary|Phase II Step: Progression-free Survival (PFS)|PFS was defined as the duration of time from the start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to the RECIST) or death.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Months||Inter-Quartile Range|Median
2773956|NCT00711594|Secondary|Phase II Step: Duration of Clinical Benefit|Presented as duration of disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Weeks||Full Range|Median
2773957|NCT00711594|Secondary|Phase I Step: Summary of Epidermal Growth Factor Receptor (EGFR) Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
2773958|NCT00711594|Secondary|Phase II Step: Duration of Objective Response|Duration of objective response was defined as the time at which RECIST was first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||weeks||Full Range|Median
2773959|NCT00711594|Secondary|Phase II Step: Time to Objective Response|Number of participants with first response at week 4, 8 and 12, assessed by investigator and independent review.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||Number of patients|||Number
2773960|NCT00711594|Secondary|Phase II Step: Clinical Benefit|Clinical benefit was defined as a RECIST assessment of complete response, partial response, or stable disease according to the best response to study treatment as defined in the previous section. Clinical benefit presented as the disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||percentage of participants||95% Confidence Interval|Number
2773961|NCT00711594|Secondary|Phase I Step: AUC0-24, AUCtau,ss of BIBW 2992 After Multiple Oral Administration|area under the concentration-time curve of BIBW 2992 over the time interval 0-24 hours (AUC0-24), Area under the concentration-time curve of Afatinib in plasma at steady state (AUCtau,ss) after multiple oral administration Pharmacokinetic was abbreviated to PK.|AUC0-24: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00 on Day 1-2 in Course 1; AUCtau,ss: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00, 48:00, 72:00 on Day 28-31 in Course 1|"“Treated set” was defined as all patients who received at least 1 dose of BIBW2992. Some samples were excluded from calculation of descriptive statistics of plasma concentration because these were taken outside the allowed time-windows but used for calculation of PK parameters.~Number of analyzed patients of BIBW 50mg:5(AUCtau,ss), 40mg:2(AUC0-24)"|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2773962|NCT00711594|Primary|Phase II Step: Objective Tumour Response According to Response Evaluation Criteria in Solid Tumours (RECIST)|The objective response (complete response [CR] and partial response [PR]) was defined as determined by the RECIST according to the best response to study treatment.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation), up to 41.3 months|"The full analysis set of patients was defined as all patients included in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||percentage of participants||95% Confidence Interval|Number
2773963|NCT00711594|Primary|Phase I Step: Safety of BIBW 2992 Assessed Based on Incidence of Dose Limiting Toxicity (DLT) and Incidence & Intensity of Adverse Events According to CTCAE||start of treatment to end of treatment|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
2773964|NCT00711555|Secondary|no Significant Nausea|defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
2773965|NCT00711555|Secondary|no Nausea|defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
2773966|NCT00711555|Secondary|no Emesis||cycle 1, day 1||||%|||Number
2773969|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.|Week 8||||units on a scale (HFRDIS)||Full Range|Median
2773970|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.|Week 4||||units on a scale (HFRDIS)||Full Range|Median
2773971|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).|Baseline||||units on a scale (HFRDIS)||Full Range|Median
2773972|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 8||||units on a scale (severity score)||Full Range|Median
2773973|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 4||||units on a scale (severity score)||Full Range|Median
2773974|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Baseline||||units on a scale (severity score)||Full Range|Median
2773975|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark."|Week 8||||daily hot flashes||Full Range|Median
2773976|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark."|Week 4||||daily hot flashes||Full Range|Median
2773995|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2773977|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries."|Baseline||||daily hot flashes||Full Range|Median
2773978|NCT00711516|Secondary|Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test|"During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (Psychomotor Vigilance Test [PVT]-like task, nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner—in this instance, the + symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented."|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline|||milliseconds (ms)||Standard Error|Least Squares Mean
2773979|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
2773980|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
2773981|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
2773982|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline|||Voxels||Full Range|Median
2773983|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline|||BOLD signal intensity||Full Range|Median
2773984|NCT00711516|Secondary|Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline|||BOLD signal intensity||Full Range|Median
2773985|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline|||BOLD signal intensity||Full Range|Median
2773986|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline|||BOLD signal intensity||Full Range|Median
2773987|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
2773988|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
2773989|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
2773990|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis among non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
2773991|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
2773992|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had a response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
2773993|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
2773994|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test defined as subjects who had a response latency of < 713 ms at Endpoint|||Activated voxels||Standard Error|Mean
2774049|NCT00711412|Secondary|Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.||At time of sugery|No data was collected for this outcome measure. There is no data to report on.||||||
2774137|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)||Baseline to Week 96|Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.|||ratio||Standard Deviation|Mean
2773996|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2773997|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2773998|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2773999|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2774000|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2774001|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline|||Correlation Coefficient|||Number
2774002|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
2774003|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent change in BOLD signal||Full Range|Median
2774004|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent change in Bold signal||Full Range|Median
2774050|NCT00711412|Secondary|Toxicity Profile|"Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~Only incidents of AEs determined to be related to chemotherapy are recorded here."|During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.|Toxicity data was collected and analysed for the first 40 patients.|||participants|||Number
2774005|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline|||Percent change in BOLD signal||Full Range|Median
2774006|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Percentage change in BOLD signal||Full Range|Median
2774007|NCT00711516|Secondary|Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint|"The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from none of the time to all of the time. The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported."|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Population defined as subjects who had at least one efficacy evaluation after baseline.|||Units on a scale||Standard Error|Least Squares Mean
2774008|NCT00711516|Secondary|Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint|Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient's condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Participants|||Number
2774009|NCT00711516|Secondary|Epworth Sleepiness Scale Change From Baseline to Endpoint|The patient's evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient's propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full analysis set defined as subjects who had at least one efficacy evaluation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2774010|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Choices to correct||Standard Deviation|Mean
2774011|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy measure after baseline|||Choices to correct||Standard Deviation|Mean
2774012|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Standard Deviation|Mean
2774051|NCT00711412|Secondary|Patterns of Failure||At time of surgery|No data collected for this outcome measure. There is no data to report on.||||||
2774013|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Milliseconds (ms)||Standard Deviation|Mean
2774014|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Full Range|Median
2774015|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Full Range|Median
2774016|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint|"The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient's ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another delayed recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment."|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent correct trials|Participants|Standard Deviation|Mean
2774017|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint|The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient's ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent correct trials|Participants|Standard Deviation|Mean
2774018|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus|The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set|||Activated voxels||Standard Error|Mean
2774019|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)|The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Activated voxels||Standard Deviation|Mean
2774020|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)|The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Activated Voxels||Standard Deviation|Mean
2774144|NCT00711009|Secondary|Mean Change From Baseline in Chloride (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2774021|NCT00711516|Secondary|Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed|The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Milliseconds (ms)||Standard Deviation|Mean
2774022|NCT00711516|Primary|Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation|The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Efficacy analyses were performed on the full analysis dataset which includes those patients in the safety analysis set who had at least 1 post baseline primary efficacy assessment.|||Activated voxels||Standard Deviation|Mean
2774023|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)||12 months|||||||
2774024|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)||6 months|||||||
2774025|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|12 months||||μm||Full Range|Median
2774026|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months||||μm||Full Range|Median
2774027|NCT00711490|Secondary|Change in Visual Acuity From Baseline to 12 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|12 months||||ETDRS letters||Full Range|Median
2774028|NCT00711490|Primary|Change in Visual Acuity From Baseline to 6 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months||||ETDRS letters||Full Range|Median
2774029|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
2774030|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
2774031|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
2774032|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
2774033|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
2774034|NCT00711477|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2774145|NCT00711009|Secondary|Mean Change From Baseline in Potassium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2774035|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The External Eating subscale consisted of 10 items and the scores ranged from 10 (better outcome) to 50 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2774036|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating B subscale (diffuse emotions) consisted of 4 items and the scores ranged from 4 (better outcome) to 20 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2774037|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating A subscale (clearly labeled emotions) consisted of 9 items and the scores ranged from 9 (better outcome) to 45 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2774038|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2774039|NCT00711477|Secondary|Percent Change in Body Weight||Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percentage of body weight||Standard Error|Least Squares Mean
2774040|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
2774041|NCT00711464|Secondary|Heart Rate|beats per minute|3-5 hours||||beats per minute||Standard Deviation|Mean
2774042|NCT00711464|Secondary|Systolic Blood Pressure|systolic blood pressure in mm Hg|3-5 hours||||mm Hg||Standard Deviation|Mean
2774043|NCT00711464|Primary|Cognitive Performance|Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control|3-5 hours||||percentage correct of all trials||Standard Deviation|Mean
2774044|NCT00711425|Primary|Marginal Bone Adaptation|Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.|||Millimeter|Participants|Standard Deviation|Mean
2774045|NCT00711425|Primary|Implant Stability|Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.|||ISQ|Participants|Standard Deviation|Mean
2774046|NCT00711425|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).|||Percentage of implants|Participants||Number
2774047|NCT00711412|Post-Hoc|Overall Survival||From the start of treatment and then every 3 months until death or a maximum of 24 months.|1 patient was registered to the study, but was not treated on study and was therefore not evaluable. Data for overall surivival was collected at 3 months, 6 months, 12 months and 24 months. There was no further data analysis completed|||percentage of patients alive|||Number
2774048|NCT00711412|Post-Hoc|Determine Progressive Free Survival||After cycles 2, and 4 (pre-surgery) 30 days after surgery and then every 3 months until first documentation of progressive disease, death and up to a maximum of 24 months.|The only data collected for this outcome measure was progression free survival rate at 3 months, 6 months, and 12 months.|||percentage of patents progression free|||Number
2774052|NCT00711412|Secondary|Time to Progression|Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.|From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.|Data collected was not analyzed before the study was terminated. Count of participants indicates the number of patients with progressive disease or death at the time the study closed permanently.|||Participants|||Count of Participants
2774053|NCT00711412|Secondary|Recurrence Rate|Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.|From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.|1 patient was registered but not treated on study and therefore was not evaluable.|||Participants|||Count of Participants
2774054|NCT00711412|Secondary|Clinical Response Rate|"Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .~Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD"|four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery|1 patient was registered to the study but was not treated on study and was therefore not evaluable.|||Participants|||Count of Participants
2774055|NCT00711412|Primary|Determine Pathologic Complete Response|"Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.~Pathologic response will be defined as:~P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer"|At time of surgery|Patients analyzed were patients that reached and completed surgery.|||Participants|||Count of Participants
2774056|NCT00711347|Secondary|Surgeon Survey|"Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported:~Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult~Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree~Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective"|Time of Surgery||||Units on a scale||Standard Deviation|Mean
2774057|NCT00711347|Secondary|Aqueous Signs - Edema|"Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale:~0 = none~= mild - slight localized or generalized edema~= moderate - significant localized or generalized edema~= severe - advanced localized or generalized edema"|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
2774058|NCT00711347|Secondary|Aqueous Signs - Flare|"Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale:~0:No-Visible flare when compared with the normal eye.~Mild-Flare visible against dark papillary background but not visible against iris background.~Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
2774059|NCT00711347|Secondary|Aqueous Signs - Cells|Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
2774060|NCT00711347|Secondary|Intraocular Pressure (IOP)|Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.|1 Day Postoperative|14 patients/28 eyes in each group.|||mmHg||Standard Deviation|Mean
2774061|NCT00711347|Primary|Corneal Endothelial Cell Loss|Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.|1 month|14 patients/28 eyes in each group.|||Percent change||Standard Deviation|Mean
2774062|NCT00711269|Secondary|Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)|Proportion of participants with treatment-emergent adverse events. An adverse event was considered serious if it met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Was considered to be an important medical event.|From Baseline to up to 8 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.|||Participants|||Count of Participants
2774063|NCT00711269|Secondary|Proportion of Participants With TEAEs Leading to Discontinuation||From Baseline to up to 8 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.|||Participants|||Count of Participants
2774086|NCT00711191|Secondary|Time to Progression|Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions.|Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774064|NCT00711269|Secondary|Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)|Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a study participant who was taking a medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period.|From Baseline to up to 8 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment period.|||Participants|||Count of Participants
2774065|NCT00711269|Secondary|Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)|The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.|Baseline and Week 6 (LOCF)|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
2774066|NCT00711269|Secondary|Change From Baseline in the PANSS Negative Subscales at Week 6|The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Baseline and Week 6 (LOCF)|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
2774067|NCT00711269|Secondary|Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)|The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Baseline and Week 6 (LOCF)|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
2774068|NCT00711269|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline and Week 6 [Last Observation Carried Forward (LOCF)]|FAS (Full Analysis Set)|||units on a scale||Standard Deviation|Least Squares Mean
2774069|NCT00711243|Post-Hoc|Median Overall Survival (OS)|Median Overall Survival (OS)|From first day of treatment until death from any cause measured, assessed up to 4 years|Patients enrolled in phase II portion of the study were evaluable for OS. One patient in phase II was registered to the study but did not receive treatment and was not evaluable for OS. Two patients did not have death dates and were censored for the last known time to be living.|||Months||95% Confidence Interval|Median
2774070|NCT00711243|Secondary|Toxicity Profile|"Toxicity data will be collected on day 1 of every 14 day cycle during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events (AE) version 3.0 (CTCAE v3.0). For patients that experience multiple grades of the same AE that is determined to be at least possibly related to at least one study drug, only highest grade will be collected. In general AEs will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of each cycle of therapy with 1 cycle =14 days until disease progression for up to a maximum of 34 cycles and 30 days after last treatment|Data collected and analyzed for patients enrolled in the phase II of the study only.1 Patient did not receive treatment on study and was not evaluable. For each patient that experienced the toxicity, highest grade for that patient is recorded. Grades ranging between 1-5 were collected and are represented below.|||participants|||Number
2774071|NCT00711243|Secondary|Frequency of DPD and TSER Polymorphisms and Their Impact on Fluorouracil Toxicity||Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle|Data not collected.||||||
2774072|NCT00711243|Secondary|Frequency of XRCC1 and ERCC2 Polymorphisms and Their Impact on Oxaliplatin Toxicity||Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle|Data not collected.||||||
2774073|NCT00711243|Secondary|Frequency of CYP3A4, CYP3A5, and MDR Polymorphisms and Their Impact on Docetaxel Toxicity||Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle|Data not collected.||||||
2774074|NCT00711243|Secondary|Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil|"Dose limiting toxicities (DLT) will be graded according to National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) except for neurosensory. The occurrence of any of the following during the 1st cycle, seen in more than one patient, will constitute a DLT.~Grade 3 non-hematologic toxicity(except alopecia) Grade 4 thrombocytopenia, not recovered to platelet count of >75,000/ul by day 15.~Grade 4 neutropenia, not recovered to count of >1,500/ul by day 15. Grade 4 neutropenia with fever or infection. Grade 2 neurologic-sensory toxicity not recovered to grade 1 or better by day 15"|After 1 cycle of therapy (1 cycle = 14 days)|15 patients enrolled in 5 dose escalating cohorts were monitored for DLTs in the phase I part of the study.|||participants|||Number
2774138|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2774075|NCT00711243|Primary|Response Rate in Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (Phase II)|"Overall Response Rate (ORR) is defined as Complete Response (CR) plus Partial Response (PR) and will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan.~Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum.~Stable Disease, neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study.~Progressive Disease - <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|After 4 cycles of therapy (1 cycle = 14 days)|One patient that was registered to phase II did not get treated on study and was therefore not evaluable. Two patients did not reach first response at 4 cycles and therefore were not evaluable.|||percentage of patients|||Number
2774076|NCT00711243|Primary|Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I)|"The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts:~Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2~3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined.~DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0"|After completion of 1 cycle of therapy (1 cycle = 14 days)|Dose of docetaxel was escalated up through 5 cohorts.|||mg/m2|||Number
2774077|NCT00711191|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer|Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.|Baseline up to time of determination of maximum tolerated dose (MTD)|Safety population|||mg/kg|||Number
2774078|NCT00711191|Secondary|Carbohydrate Antigen 19-9 (CA 19-9)|CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.|At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774079|NCT00711191|Secondary|18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)|FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.|Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774080|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)|Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production.|Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774081|NCT00711191|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774082|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774083|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774084|NCT00711191|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast analyzed using a noncompartmental approach to estimate individual participant values.|Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774085|NCT00711191|Secondary|Maximum Serum Concentration (Cmax)||Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
2774087|NCT00711191|Secondary|Progression Free Survival (PFS)|PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions.|||months||95% Confidence Interval|Median
2774088|NCT00711191|Secondary|Overall Survival (OS)|OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.|||months||95% Confidence Interval|Median
2774089|NCT00711191|Secondary|Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response|Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.|||percentage of participants||95% Confidence Interval|Number
2774090|NCT00711191|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|"Any of the following during first cycle of treatment and attributable to CP-870893:~afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia)."|Baseline up to Cycle 1 / Day 28|Safety population: all participants who received any study treatment. Cubic millimeters (mm^3).|||participants|||Number
2774091|NCT00711113|Primary|Marginal Bone Adaptation|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At baseline (loading) and at 5 year follow-up|Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.|||Millimeter|Participants|Standard Deviation|Mean
2774092|NCT00711113|Primary|Implant Stability|Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.|||units on a scale|Participants|Standard Deviation|Mean
2774093|NCT00711113|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.|||percentage of implants|Participants||Number
2774094|NCT00711100|Primary|Abstinence From Cigarettes|Abstinence from cigarettes during Abstinence Phase.|Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)|At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase. Abstinence from cigarettes was determined during the 2 week study product phase (e.g., Abstinence Phase) and 1 week after this phase.|||Participants|||Count of Participants
2774095|NCT00711100|Primary|Product Preference|Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).|2 weeks||||participants|||Number
2774096|NCT00711087|Primary|A Change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A Injected Group (Group 1) Compared to the Sham Saline Injected Group (Group 2).|This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.|2.5 years|Early spinal cord injury||||||
2774097|NCT00711022|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5-year follow-up|Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 implants failed during the 5 year follow-up period.|||percentage of implants|Participants||Number
2774098|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams/cm^2||Standard Deviation|Mean
2774100|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774101|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774102|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774103|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774104|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774105|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774106|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774107|NCT00711009|Secondary|Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774108|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774109|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774110|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774111|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
2774112|NCT00711009|Secondary|Mean Change From Baseline in Mid-Thigh Measurement (cm)|Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
2774113|NCT00711009|Secondary|Mean Change From Baseline in Hips Measurement (cm)|Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
2774146|NCT00711009|Secondary|Mean Change From Baseline in Sodium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2774114|NCT00711009|Secondary|Mean Change From Baseline in Mid-Arm Measurement (cm)|Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
2774115|NCT00711009|Secondary|Mean Change From Baseline in Waist Measurement (cm)|Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
2774116|NCT00711009|Secondary|Mean Change From Baseline in Chest Measurement (cm)|Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||cm||Standard Deviation|Mean
2774117|NCT00711009|Secondary|Mean Change From Baseline in Temperature (°F)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||°F||Standard Deviation|Mean
2774118|NCT00711009|Secondary|Mean Change From Baseline in Weight (kg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||kg||Standard Deviation|Mean
2774119|NCT00711009|Secondary|Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||beats per minute||Standard Deviation|Mean
2774120|NCT00711009|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||mm Hg||Standard Deviation|Mean
2774121|NCT00711009|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||mm Hg||Standard Deviation|Mean
2774122|NCT00711009|Secondary|Mean Change From Baseline in Urine pH||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||pH||Standard Deviation|Mean
2774123|NCT00711009|Secondary|Mean Change From Baseline in Urine Specific Gravity|Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||ratio of urine density to water density||Standard Deviation|Mean
2774124|NCT00711009|Secondary|Mean Change From Baseline in Insulin (Picomoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picomoles/liter||Standard Deviation|Mean
2774125|NCT00711009|Secondary|Mean Change From Baseline in Leptin (Nanograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||nanograms/milliliter||Standard Deviation|Mean
2774126|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picograms/milliliter||Standard Deviation|Mean
2774127|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picograms/milliliter||Standard Deviation|Mean
2774128|NCT00711009|Secondary|Mean Change From Baseline in Lactate (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
2774129|NCT00711009|Secondary|Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||nanograms/liter||Standard Deviation|Mean
2774130|NCT00711009|Secondary|Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micrograms/milliliter||Standard Deviation|Mean
2774131|NCT00711009|Secondary|Mean Change From Baseline in Magnesium (Millimoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
2774132|NCT00711009|Secondary|Mean Change From Baseline in Lipase (Units/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
2774133|NCT00711009|Secondary|Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
2774134|NCT00711009|Secondary|Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
2774135|NCT00711009|Secondary|Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||milliliters/second||Standard Deviation|Mean
2774136|NCT00711009|Secondary|Mean Change From Baseline in Triglycerides (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
2774165|NCT00711009|Secondary|Mean Change From Baseline in Hematocrit (Fraction)|Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||% by volume of packed RBCs in blood||Standard Deviation|Mean
2774166|NCT00711009|Secondary|Mean Change From Baseline in Hemoglobin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
2774167|NCT00711009|Secondary|Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication|The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2774168|NCT00711009|Secondary|Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication|The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2774169|NCT00711009|Secondary|Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)|The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2774170|NCT00711009|Secondary|Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||Scores on a scale||Standard Error|Mean
2774171|NCT00711009|Secondary|Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||Scores on a scale||Standard Error|Mean
2774172|NCT00711009|Secondary|Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir|Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/mL to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.|||Participants|||Number
2774173|NCT00711009|Secondary|Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.|Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/ml to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.|||Participants|||Number
2774174|NCT00711009|Secondary|Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672|Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.|Baseline to Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2774175|NCT00711009|Secondary|Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit||Baseline to Week 96|Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.|||cells/microliter||Standard Error|Mean
2774176|NCT00711009|Primary|Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values|Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.|Baseline to Week 96|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.|||Percentage of participants|||Number
2774177|NCT00711009|Secondary|Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 96|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2774178|NCT00711009|Primary|Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.|Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2774179|NCT00711009|Primary|Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 48|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2774180|NCT00710996|Primary|Photostress Recovery Time in Seconds.|The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.|3 months||||seconds||Standard Deviation|Mean
2774181|NCT00710970|Primary|Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate.||4 months||||participants|||Number
2774182|NCT00710970|Primary|Tamoxifen : Tamoxifen is Administered at 20 mg/Day as a Single Daily Oral Dose. Tamoxifen is Continued Until Progressive Disease or Intolerable Grade 3 or 4 Side Effects Occur Due to Tamoxifen.||To progression|||||||
2774183|NCT00710944|Primary|Implant Survival|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|12 months after implant placement|Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.|||percentage of implants|Participants||Number
2774184|NCT00710931|Primary|Binocular Visual Acuity at Distance, Near and Intermediate|"Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after surgery||||LogMAR||Standard Deviation|Mean
2774185|NCT00710905|Primary|Binocular Visual Acuity at Near, Intermediate and Distance|"Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better VA."|6 months after surgery||||LogMAR||Standard Deviation|Mean
2774186|NCT00710879|Secondary|Solution Utlility|The Utility was determined based on the results of the efficacy and safety evaluations.|3 months, 6 months|All Eligible, Dispensed Eyes|||Eyes|Participants||Number
2774187|NCT00710879|Secondary|Solution Related AE's and Lens Changes|Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.|3 months, 6 months|All Eligible, Dispensed Eyes|||Eyes|Participants||Number
2774208|NCT00710749|Primary|Mean Urine Flow Rate|Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.|At every voiding event during approximately one week.|Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.|||ml/s||Standard Deviation|Mean
2774188|NCT00710879|Primary|Antimicrobial Efficacy|Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae|2 weeks, 3 months|All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.|||Eyes|Participants||Number
2774189|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol|||participants|||Number
2774190|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Infants 6-11 Months|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol|||participants|||Number
2774191|NCT00710866|Primary|Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
2774192|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)||27-46 days after the second dose|Per Protocol|||participants|||Number
2774193|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
2774194|NCT00710866|Primary|Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
2774195|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
2774196|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
2774197|NCT00710840|Secondary|Functional Performance: Stair Climb Test|This outcome measures the time (seconds) it takes to climb up and back down 12 steps.|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Seconds||Standard Deviation|Mean
2774198|NCT00710840|Primary|Knee Range of Motion|Knee Flexion Active Range of Motion (AROM)|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||degrees||Standard Deviation|Mean
2774199|NCT00710840|Secondary|Functional Performance: 6 Minute Walk (6MW) Distance||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Meters||Standard Deviation|Mean
2774200|NCT00710840|Primary|Quadriceps Muscle Force||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Nm/kg||Standard Deviation|Mean
2774201|NCT00710814|Primary|Weight Change (in kg.) After Each Intervention|"For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period.~For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period."|0 weeks, 16 weeks and 32 weeks||||kg weight change||95% Confidence Interval|Mean
2774202|NCT00710762|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters|Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|First drug administration until 28 days after last drug administration, up until 309 days|Treated set|||Percentage of participants|||Number
2774203|NCT00710762|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First drug administration until 28 days after last drug administration,up until 309 days|Treated set|||percentage of participants|||Number
2774204|NCT00710762|Secondary|Time to Death|This end point was not determined as no patients died during the trial.|9 months|This endpoint could not be calculated as no patients died.||||||
2774205|NCT00710762|Secondary|Time to Tumour Progression|"Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.~For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:~Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.~Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD."|9 months|Treated set|||days||95% Confidence Interval|Median
2774206|NCT00710762|Secondary|PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)|The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|12 weeks (after 3 months) and 24 weeks ( after 6 months)|Treated set|||percent probability of PFS||95% Confidence Interval|Number
2774207|NCT00710762|Primary|PFS Rate at 36 Weeks (After 9 Months)|The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|36 weeks (after 9 months)|Treated set.|||percent probability of PFS||95% Confidence Interval|Number
2774209|NCT00710684|Secondary|Change From Baseline in RBANS Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
2774210|NCT00710684|Secondary|Change From Baseline in CDR-SB Scale in Participants With APOE4 Gene|"Genetic analyses was conducted to assess the effect of APOE4 carriage. The CDR-SB is an interviewer administered scale and impairment is scored in following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment was scored on a scale in which none =0, questionable =0.5, mild =1, moderate =2 and severe =3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher score indicating severe impairment. If there were any missing items then CDR-SB was set to missing and was not imputed. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value."|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
2774211|NCT00710684|Secondary|Change From Baseline in ADAS-Cog Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five-point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores were recorded on the CRF for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population consisted of all participants in the ITT population who had evaluable PGx data. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
2774212|NCT00710684|Secondary|Exposure Estimates for Donepezil (Cavgss)|Participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) were allowed to participate in this study. Cavgss for donepezil approximately 12 to 20 hours after dosing were summarized by donepezil dose level 5 mg/7.5 mg/10 mg/15 mg.|Post-dose at 12 to 20 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|Donepezil PK population comprised of participants who received a stable dose of donepezil 5 mg/7.5 mg/10 mg/15 mg. Analysis is exclusively for Cavgss of donepezil therefore the two arms SB-742457 15 mg and SB-742457 35 mg have not been presented.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2774213|NCT00710684|Secondary|Exposure Estimates for SB-742457 : Minimum Concentrations at Steady State (Cmin-ss)|Cmin-ss was estimated via nonlinear mixed effect analysis. This PK model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.|Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2774214|NCT00710684|Secondary|Exposure Estimates for SB-742457 : Area Under the Concentration Time Curve Over the Dosing Interval at Steady State (AUCτss)|AUCτss of SB-742457 was estimated via nonlinear mixed effect analysis. This pharmacokinetic(PK) model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.|Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|PK population included all participants for whom a pharmacokinetic sample was obtained and analyzed.|||Nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2774215|NCT00710684|Secondary|Number of Participants With Parameters of Clinical Concern - Clinical Chemistry|Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Alanine Amino Transferase (ALT) (high-1.5), Alkaline Phosphatase (high-1.5), Aspartate Amino Transferase (ASAT) (high-1.5), BUN/Creatinine ratio (high-1.5), Calcium (low- 0.75, high-1.25), Carbon dioxide content/Bicarbonate (low-15, high- 40), Cholesterol (high-1.25), Creatine Kinase ((low- 0.5, high-1.25), Creatinine (low- 0.5, high-1.25), Direct Bilirubin (high-1.5), Gamma Glutamyl Transferase (GGT) (high-2), Glucose (low- 3.6, high-7.8), HDL Cholesterol (low-0.65), LDL Cholesterol (hig-1.25), Magnesium (low-0.5, high-2), Phosphorus inorganic (low- 0.5, high-1.5), Potassium (low- 3, high-5.5), Sodium (low- 130, high-150), Total Bilirubin (high-1.5), Triglycerides (high -4) and Urea/BUN (high-11).|Up to Week 48|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2774216|NCT00710684|Secondary|Number of Participants With Parameters of Clinical Concern - Hematology|Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Eosinophils (high-2), Hematocrit (low- 0.8, high-1.2), Lymphocytes (low-0.75, high-1.5), Mean Corpuscle Hemoglobin (MCH) (low-0.8, high-1.2), Monocytes(low-0.75, high-2), Neutrophil bands (high-10), Platelet count (low-100, high-500), Segmented Neutrophils (low-0.75, high-1.3), Total Neutrophils (low-0.75, high-1.5), and white blood cells (WBC) (low-3, high-15).|Up to Week 48|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2774235|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
2774236|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
2774217|NCT00710684|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During Treatment Phase|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up i.e. 2 weeks post end of treatment (Week 24, Week 48 or Early Withdrawal)|Safety population consisted of all participants randomized to treatment who had received at least one dose of study medication.|||Participants|||Count of Participants
2774218|NCT00710684|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 24 and 48|The MMSE consisted of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Scores for each of the 11 individual tests were not recorded on the CRF, therefore if any item was missing then the total score was be set to missing. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 24 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774219|NCT00710684|Secondary|Change From Baseline in Alzheimer's Disease Co-operative Study Group - Activities of Daily Living Inventory (ADCS- ADL) Total Score at Weeks 12, 24, 36 and 48|The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions ranged from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signified greater functional ability. The questionnaire was split into two types of questions, an initial question relating to whether a participant had completed a particular activity and then a follow on question which scored how much assistance the participant had required if they had performed that particular activity. The total score was calculated by adding up the responses for each of the individual activities. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 24, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774220|NCT00710684|Secondary|Change From Baseline in RBANS Score at Week 12, 36 and 48|RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774221|NCT00710684|Secondary|Change From Baseline in CDR-SB Score at Week 12, 36 and 48|"The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented."|Baseline (Week 0) and Week 12, 36, 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774222|NCT00710684|Secondary|Change From Baseline in ADAS-Cog Total Score at Week 12, 36 and 48|ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the CRF for questions 3 to 6 and 8 to 11. In cases where more than one question was missing, a total score was not be imputed. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been present|Baseline (Week 0) and Week 12, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774223|NCT00710684|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24|RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774237|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
2774224|NCT00710684|Primary|Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Week 24|"The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented."|Baseline(Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774225|NCT00710684|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 24|ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the case report form (CRF) for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean is presented.|Baseline(Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774226|NCT00710606|Secondary|Mean Endometrial Proliferation|The mean endometrial proliferation from week 1, week 2 and week3|Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||millimeters||Standard Deviation|Mean
2774227|NCT00710606|Secondary|Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up|Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).|continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||Participant w/follicular diameter >=13mm|||Number
2774228|NCT00710606|Primary|Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol|Serum concentrations were obtained from thirty-seven women completed follow-up.|Measurements at Week 3 and Week 6 continuous ring use|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||ng/L||95% Confidence Interval|Geometric Mean
2774229|NCT00710593|Secondary|Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).|Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.|Day 1 through Week 24||||AEs/Total Number of Participants|||Number
2774230|NCT00710593|Secondary|Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.|Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.|Day 1 through Week 24||||percentage of days||Standard Deviation|Mean
2774231|NCT00710593|Secondary|"Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure)"|"To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline 12-item Knowledge About HPV and HPV Vaccine measure was used to evaluate the need for safer sexual behaviors."|Week 48|Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.|||percentage of participants|||Number
2774232|NCT00710593|Secondary|Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination|"Participants' perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:~After getting vaccinated against HPV …~You feel that condom use during sex is less necessary.~You feel it is still just as important to have as few sexual partners as possible.~You feel that it is less important to talk to your sex partners about safe sex.~You think it is still just as important to use a condom every time you have sex.~You will be less worried about having unprotected sex. Those who were categorized in the lower need for safer sexual behaviors (NSSB) group had a summary score that was less than the median and those in the higher NSSB group had a summary score that was equal to or higher than the median."|Week 48||||percentage of participants|||Number
2774233|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
2774234|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
2774238|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative for at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
2774239|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
2774240|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
2774241|NCT00710593|Primary|HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
2774242|NCT00710593|Primary|HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
2774243|NCT00710593|Primary|HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
2774244|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||mMU/mL||Standard Deviation|Geometric Mean
2774245|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||mMU/mL||Standard Deviation|Geometric Mean
2774246|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
2774247|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 48|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
2774248|NCT00710593|Secondary|Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine|When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.|Entry, Week 8, and Week 24|Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.|||participants|||Number
2774249|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18|Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
2774250|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16|Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
2774453|NCT00709124|Secondary|Hospital Discharge Destination (e.g., Home, Rehab Facility)|Discharge location after hospital stay.|Hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||Participants|||Count of Participants
2774251|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11|Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
2774252|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6|Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.|||participants|||Number
2774253|NCT00710593|Primary|HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)|The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at baseline (BL).|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
2774254|NCT00710554|Secondary|Incidence of Adverse Events as a Measure of Subject's Safety.|The number of subjects that reported an adverse event in this study is presented.|19 weeks|All subjects were included in this analysis.|||participants|||Number
2774255|NCT00710554|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)|Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|Days 0-7 and Days 92-98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||number of tablets||Standard Deviation|Mean
2774256|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774257|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774258|NCT00710554|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774259|NCT00710554|Secondary|Subject Global Impression of Change|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported."|Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||participants|||Number
2774260|NCT00710554|Secondary|Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)|Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774271|NCT00710424|Secondary|Subject Global Impression of Change at the End of Treatment|The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
2774454|NCT00709124|Secondary|Total Hospital Charges|The total dollar amount of charges from hospital stay|Hospital discharge||||US dollars||Standard Deviation|Mean
2774261|NCT00710554|Secondary|Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774262|NCT00710554|Secondary|Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774263|NCT00710554|Secondary|Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774264|NCT00710554|Primary|Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)|"The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|Day 7 to Day 98|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774265|NCT00710424|Primary|Number of Responders at the 30% Improvement Level at the End of Treatment|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period."|Day 0 - Day 98|All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders.|||participants|||Number
2774266|NCT00710424|Secondary|Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment|"Subjects rated their intoxication levels on a scale of 0-10, where 0 equals no intoxication and 10 equals extreme intoxication. A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded."|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774267|NCT00710424|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.|Day 0 - Day 133|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
2774268|NCT00710424|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End of Treatment|The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||Tablets||Standard Deviation|Mean
2774269|NCT00710424|Secondary|Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale|The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774270|NCT00710424|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment|The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774455|NCT00709124|Secondary|ICU and In-hospital Mortality|The number of patients who died in the ICU and those who died by hospital discharge.|ICU discharge and Hospital discharge||||Participants|||Count of Participants
2774272|NCT00710424|Secondary|Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment|"The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment)."|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774273|NCT00710424|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774274|NCT00710424|Primary|The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis."|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2774275|NCT00710385|Secondary|"Drug Liking"|"Participant's subjective ratings of how much they Like the dose they just received on a scale of 0 -100."|Peak (highest) rating obtained following drug administration throughout the entire 3 hr session||||units on a scale||Standard Error|Mean
2774276|NCT00710385|Primary|Drug's Breakpoint|"Measure of a drug's reinforcing effects. The Breakpoint is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested"|Single measurement taken following each of the 7 IV experimental doses|Heroin users, not seeking treatment|||number of clicks on a mouse||Standard Deviation|Mean
2774277|NCT00710203|Other Pre-specified|Evidence of Texture Irregularities|The physician assessed evidence of texture irregularities.|6 to 12 weeks||||lesions|||Number
2774278|NCT00710203|Other Pre-specified|Evidence of Scar|The physician assessed evidence of scar.|6 to 12 weeks||||lesions|||Number
2774279|NCT00710203|Other Pre-specified|Evidence of Hyperpigmentation|The physician assessed evidence of hyperpigmentation.|6 to 12 weeks||||lesions|||Number
2774280|NCT00710203|Other Pre-specified|Evidence of Hypopigmentation|The physician assessed evidence of hypopigmentation.|6 to 12 weeks||||lesions|||Number
2774281|NCT00710203|Primary|Percent Clearance of All Lesions|The physician assessed percent clearance of all treated lesions and the control lesion.|6 to 12 weeks||||percentage of lesion clearance|Participants|Standard Deviation|Mean
2774282|NCT00710034|Secondary|Product Effect on Biomarkers of Exposure and Toxicity|Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).|Baseline and Week 4 post smoking substitution||||pmol//mg creatinine||Standard Deviation|Mean
2774283|NCT00710034|Secondary|Products Effect on Withdrawal Symptoms.|Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.|Week 1-12 post switching|Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.|||units on a scale||Standard Deviation|Mean
2774284|NCT00710034|Primary|Number of Products Used|Pieces of product per week at mid intervention|6 weeks post smoking substitution||||Pieces per week||Standard Deviation|Mean
2774285|NCT00710034|Primary|Number of Cigarettes Smoked|Cigarettes per day at mid intervention|6 weeks post cigarette substitution||||cigarettes per day||Standard Deviation|Mean
2774286|NCT00710034|Primary|Product Effect on Complete Substitution for Smoking|Number of subjects using only the assigned study product at week 6|6 week post smoking substitution||||participants|||Number
2774287|NCT00710021|Secondary|Percent of Participants With Adverse Events of Grade 3 or Above|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From start of study treatment through Week 12|Safety|||Percent of participants|||Number
2774288|NCT00710021|Secondary|Renal BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Renal-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774289|NCT00710021|Secondary|Ophthalmic BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Ophthalmic-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774290|NCT00710021|Secondary|Neuropsychiatric BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Neuropsychiatric-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774291|NCT00710021|Secondary|Musculoskeletal BILAG Status at Week 12|"Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Musculoskeletal-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774292|NCT00710021|Secondary|Mucocutaneous BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Mucocutaneous-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774293|NCT00710021|Secondary|Hematological BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Hematological-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774294|NCT00710021|Secondary|Gastrointestinal BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Gastrointestinal-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774295|NCT00710021|Secondary|Constitutional BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Constitutional-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774296|NCT00710021|Secondary|Cardiorespiratory BILAG Status at Week 12|"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Cardiorespiratory-specific body system."|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
2774297|NCT00710021|Secondary|Change in SELENA-SLEDAI Total Score From Baseline to Week 12|The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity.|0, Week 12|Modified Intent-to-Treat with available data|||Change in Scores on a Scale||Standard Deviation|Mean
2774298|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 6|Modified Intent-to-Treat with available data|||Percent of participants|||Number
2774456|NCT00709124|Secondary|ICU and Hospital Length of Stay|The number of days that the patient was in the ICU and hospital, respectively.|ICU and Hospital discharge||||days||Standard Deviation|Mean
2774299|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 12|Modified Intent-to-Treat with available data|||Percent of participants|||Number
2774300|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 6|Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
2774301|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 12|C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
2774302|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 6|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
2774303|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 12|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
2774304|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6|"The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa)."|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
2774305|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12|"The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa)."|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
2774306|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6|"The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa)."|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
2774307|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12|"The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa)."|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
2774308|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6|"The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa)."|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
2774457|NCT00709124|Secondary|Duration of Mechanical Ventilation|The number of days the patient was on mechanical ventilation.|Until hospital discharge||||days||Standard Deviation|Mean
2774309|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12|"The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa)."|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
2774310|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 6|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.|||Percent of participants|||Number
2774311|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 12|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.|||Percent of participants|||Number
2774312|NCT00710021|Secondary|Percent of Participants With an IFN Alpha Signature Response at Week 6|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.|||Percent of participants|||Number
2774313|NCT00710021|Primary|Percent of Participants With an IFN Alpha Signature Response at Week 12|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.|||Percent of participants|||Number
2774314|NCT00709995|Secondary|PK: Maximum Concentration at Steady State (Cmax,ss) of Enzastaurin + LSN326020 + Total Analytes in Part 1|PK was assessed in participants to determine the maximum concentration at steady state (Cmax, ss) of Enzastaurin + LSN326020 + total analytes.|Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanomole/liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2774315|NCT00709995|Secondary|Pharmacokinetics (PK): Area Under Concentration Time Curve During One Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin + Metabolite (LSN326020) + Total Analytes in Part 1|Pharmacokinetics (PK) was assessed in participants to determine the area under the concentration time curve during one dosing interval at steady state (AUCτ,ss) of Enzastaurin, LSN326020 and total Analytes. τ equals 12 hours for Enzastaurin, LSN326020 and total Analytes.|Cycle 1 Day 15: Predose, 2, 4, and 6 - 8 hours, Up to 12 Hours Post dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanomole*hour/liter (nmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
2774316|NCT00709995|Secondary|Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs) in Part 1|Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Randomization to Study Completion (Up to 6 Cycles)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2774317|NCT00709995|Secondary|Time-To-Tumor Progression in Part 2|Time to tumor progression (TTP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first.|Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up to 24 Months)|Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors.||||||
2774318|NCT00709995|Secondary|Overall Survival (OS) in Part 2|OS time was defined as the number of months between the date of randomization and the date of death due to any cause.|Randomization to Death from Any Cause (Up to 24 Months)|Zero participant data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors.||||||
2776340|NCT00697593|Primary|Hematology - White Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^9/L||Standard Deviation|Mean
2774319|NCT00709995|Primary|Progression Free Survival (PFS) in Part 2|Progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first.|Randomization to Measured Progressive Disease (PD) (Up to 24 Months)|Zero participants data were collected. Part 2 was not activated due to sponsor broad decision to not pursue Enzastaurin in solid tumors.||||||
2774320|NCT00709956|Secondary|Borg Dyspnea Score|"The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled extremely severe, or the worst possible dyspnea imaginable. Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.|||scores on a scale||Standard Deviation|Mean
2774321|NCT00709956|Primary|6-minute-walk Distance (6MWD)|"The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.~It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.|||meters||95% Confidence Interval|Least Squares Mean
2774322|NCT00709891|Secondary|Percentage of Participants With a Diagnosis of ≥ CIN3|A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the study (up to 5 years, 1 month)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).|||Percentage of participants|||Number
2774323|NCT00709891|Primary|Percentage of Participants With a Diagnosis of ≥ CIN2|A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the Baseline period (up to 12 weeks)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).|||Percentage of participants|||Number
2774324|NCT00709878|Primary|Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.||6 months||||Total number of cases|||Number
2774325|NCT00709852|Secondary|Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers|From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of lesion enhancement||Standard Deviation|Mean
2774326|NCT00709852|Secondary|Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers|Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2774327|NCT00709852|Secondary|Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher|Percentage of participants for which blinded readers said image quality was higher|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774328|NCT00709852|Secondary|Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers|The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774329|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774330|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774331|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774660|NCT00708214|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.|Baseline till progression, death or data cut-off (04 Jan 2010)|TS|||days||95% Confidence Interval|Median
2774332|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774333|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774334|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774335|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774336|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774337|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774338|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774339|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774340|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774341|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774342|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774343|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774344|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774345|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774346|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774347|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774348|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774473|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mg/dl||90% Confidence Interval|Median
2774349|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774350|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774351|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774352|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774353|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774354|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774355|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774356|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774474|NCT00709111|Secondary|Change in D-dimer|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mcg/ml||90% Confidence Interval|Median
2774357|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774358|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774359|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774360|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774361|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774362|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2774363|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2774364|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2774374|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2776341|NCT00697593|Primary|Hematology - Red Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||x10^12/L||Standard Deviation|Mean
2774365|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2774366|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2774367|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2774368|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774369|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774370|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2774371|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774372|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774373|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774499|NCT00709098|Other Pre-specified|Average Inhalation Time|Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)|12 weeks|All treated population|||minutes||Standard Deviation|Mean
2774375|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774376|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774377|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774378|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2774379|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774380|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774381|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774382|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2774383|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2774384|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774385|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2774386|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774387|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774388|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774389|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774390|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774391|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774392|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774393|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774394|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774395|NCT00709852|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
2774396|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774397|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774398|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2774399|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).|||scores on a scale||Standard Deviation|Mean
2774400|NCT00709826|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Randomization then every other cycle|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.|||Months||95% Confidence Interval|Median
2774401|NCT00709826|Secondary|Overall Survival||Randomization then every other cycle||||Months||95% Confidence Interval|Median
2774402|NCT00709761|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.|Start of treatment to disease progression or death (up to Week 131)|ITT Population|||weeks||95% Confidence Interval|Median
2774403|NCT00709761|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the start of treatment until the earliest date of disease progression or death due to breast cancer.|Start of treatment to disease progression or death (up to Week 131)|ITT Population|||weeks||95% Confidence Interval|Median
2774404|NCT00709761|Secondary|Time to Response (TTR)|TTR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first).|Start of treatment to first documented response (CR or PR) (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.|||weeks||95% Confidence Interval|Median
2774405|NCT00709761|Secondary|Duration of Response (DOR)|DOR was defined for the subset of participants who showed a confirmed CR or PR, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|First documented response (CR or PR) to disease progression or death (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.|||weeks||95% Confidence Interval|Median
2774406|NCT00709761|Secondary|Overall Survival (OS)|OS was defined as the time from the start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. OS could not be analyzed because only 13 participants had died as of data cut off, and data were not mature (greater than 75% of the participants were censored for the endpoint).|Start of treatment to death (up to Week 131)|ITT Population||||||
2774407|NCT00709761|Primary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||percentage of participants|||Number
2774408|NCT00709735|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 2 IES-R total score from the Day 8 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 2 (Baseline ) and Day 8|All randomized participants who completed the study.|||score on a scale||Standard Deviation|Mean
2774409|NCT00709735|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Traumatic Memory Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven imagery of traumatic combat events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD.|Day 8|All randomized participants who completed the study.|||percent probability||Standard Deviation|Mean
2774410|NCT00709722|Secondary|Treatment Days With Corticosteroids of <= 7.5 mg/Day|"Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).~OCS dosage was maintained, decreased or increased according to the response to DSG.~The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle."|1st and 9th Cycle|ITT population|||Days||Full Range|Mean
2774411|NCT00709722|Secondary|SELENA-SLEDAI Score|"The Safety of Estrogen in Lupus Erythematosus National Assessment - systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity."|Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks|ITT population|||Score on a scale||Full Range|Mean
2774412|NCT00709722|Primary|Complete and Partial Response Rate|A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.|Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks|ITT population|||Percentage of participants|||Number
2774413|NCT00709696|Primary|Nicotine Withdrawal Scale|Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all|21 days|Treatment-seeking smokers|||units on a scale||Standard Deviation|Mean
2774414|NCT00709618|Secondary|Overall Survival|OS is defined as the time from the start of study treatment to the date of death. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Overall survival was not assessed because the study was terminated due to low screening and a low enrollment rate after 3 years. There were no-survival follow-up visits required.|From the start of study treatment to the date of death, assessed for up to 3 years|||||||
2774415|NCT00709618|Secondary|Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine|Qualitative and quantitative toxicities associated with the combination of lapatinib and vinorelbine during the study are those adverse events (AEs) that are judged to be related to the study treatment by the investigator. Those AEs occuring in more than 5 participants in the ITT Population are listed here.|From the start of study medication until disease progression, assessed every 4 weeks for up to 2 years|ITT Population|||participants|||Number
2774416|NCT00709618|Secondary|Time to Progression (TTP), as Assessed by the Investigator|TTP is defined as the time from the start of treatment until the earliest date of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to breast cancer, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).|||weeks||95% Confidence Interval|Median
2774417|NCT00709618|Secondary|Time to Response, as Assessed by the Investigator|Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||weeks||95% Confidence Interval|Median
2774437|NCT00709228|Primary|Number of HCV LVL G1 Participants Who Relapsed|Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.|Week 24 of follow-up|The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.|||Participants|||Number
2774418|NCT00709618|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to any cause, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||weeks||95% Confidence Interval|Median
2774419|NCT00709618|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).|||weeks||95% Confidence Interval|Median
2774420|NCT00709618|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesions)/recurrence.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|Intent-to-Treat (ITT) Population: participants who received >=1 dose of investigational product. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||participants|||Number
2774421|NCT00709592|Secondary|Chronic Graft-Versus-Host Disease (GVHD)||2 year GVHD rate||||percentage of participants|||Number
2774422|NCT00709592|Secondary|Acute Graft-Versus-Host Disease (GVHD)||2 year rate (%)||||percentage of participant|||Number
2774423|NCT00709592|Secondary|Donor Lymphocyte Infusion||2 year rate of DLI||||percentage of participants|||Number
2774424|NCT00709592|Secondary|Relapse|Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.|2 year relapse rate (%)||||Percent patients relapsing|||Number
2774425|NCT00709592|Secondary|Event-free Survival||2 years||||percentage of participants|||Number
2774426|NCT00709592|Secondary|Treatment Related Mortality||Day 100||||percentage of patients|||Number
2774427|NCT00709592|Secondary|Survival||2-year survival rate (%)||||percentage of patient surviving|||Number
2774428|NCT00709592|Secondary|Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.||Up to 52 weeks post transplant.||||Days||95% Confidence Interval|Median
2774429|NCT00709592|Primary|The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.|A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).|Up to 9 months following transplant||||participants|||Number
2774430|NCT00709319|Primary|Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months|Change in thickness is followup thickness minus baseline thickness.|Baseline to 6 months||||participants|||Number
2774431|NCT00709319|Primary|Percent of Participants With Change in Visual Acuity From Baseline to Six Months||Baseline to 6 months||||Percentage of Participants||95% Confidence Interval|Number
2774432|NCT00709319|Secondary|Surgical Complications From Baseline to Six Months|Including intraoperative and perioperative medical complications. Same subject could have more than one complication|Baseline to 6 months||||Participants|||Number
2774433|NCT00709319|Primary|Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline|Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.|Baseline to 6 Months||||microns||Inter-Quartile Range|Median
2774434|NCT00709319|Primary|Visual Acuity|Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 6 months||||Units on a scale||Inter-Quartile Range|Median
2774435|NCT00709306|Primary|Sun Stage of Change at 12 Months|The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).|12 months||||Participants|||Count of Participants
2774436|NCT00709306|Primary|Sun Stage of Change at 3 Months|The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).|3 months||||Participants|||Count of Participants
2774438|NCT00709202|Secondary|Change in Appetite Fullness|"Least Squares estimated change in appetite fullness from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line How full do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line (O). indicate amount of feeling of fullness. The higher the cm number the higher the feeling of fullness. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m.) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline."|.Measured at baseline and 12 weeks||||units on a scale||Standard Error|Least Squares Mean
2774439|NCT00709202|Secondary|Change in Appetite Hunger|"Least Squares estimated change in appetite hunger from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line How Hungry do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line (O), indicate the amount of hunger. The higher the cm number the higher the feeling of hunger. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline."|Measured at baseline and 12 weeks||||units on a scale||Standard Error|Least Squares Mean
2774440|NCT00709202|Secondary|Change in Triglycerides|Least Squares estimated change in triglycerides from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||mg/dL||Standard Error|Least Squares Mean
2774441|NCT00709202|Secondary|Change in HDL|Least Squares estimated change in HDL from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||mg/dL||Standard Error|Least Squares Mean
2774442|NCT00709202|Secondary|Change in LDL|Least Squares estimated change in LDL from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||mg/dL||Standard Error|Least Squares Mean
2774443|NCT00709202|Secondary|Change in Cholesterol|Least Squares estimated change in cholesterol from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||mg/dL||Standard Error|Least Squares Mean
2774444|NCT00709202|Secondary|Change in Glucose|Least Squares estimated change in glucose from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||mg/dL||Standard Error|Least Squares Mean
2774445|NCT00709202|Secondary|Change in Hip Circumference|Least Squares estimated change in hip circumference from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||centimeters||Standard Error|Least Squares Mean
2774446|NCT00709202|Secondary|Change in Waist Circumference|Least Squares estimated change in waist circumference from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.||||centimeters||Standard Error|Least Squares Mean
2774447|NCT00709202|Secondary|Change in Body Mass Index (BMI)|Least Squares estimated change in BMI from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period.|Least Squares estimated change in BMI from end of study minus baseline for all subjects who had at least one post-baseline weight evaluation, using mixed model analysis.|||kg/m^2||Standard Error|Least Squares Mean
2774448|NCT00709202|Primary|Change in Weight|Least Squares estimated change in weight from end of study minus baseline|Measured at each visit from baseline to end of study over a 12 week period|Least Squares estimated change in weight from end of study minus baseline for all subjects who had at least one post-baseline weight evaluation, using mixed model analysis.|||kg. (killograms)||Standard Error|Least Squares Mean
2774449|NCT00709124|Secondary|Subgroup Analysis|"For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in whole body muscle strength score from baseline to ICU discharge, mean change in whole body muscle strength score from baseline to hospital discharge, and whole body muscle strength score at ICU discharge and at hospital discharge.~Each muscle group is assessed bilaterally (scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). There are three muscle groups assessed bilaterally for lower extremity (hip flexion, knee extension, and ankle dorsiflexion) (score range 0-30, higher score is better i.e. stronger); while for whole body strength assessment (score range 0-360, higher score is better), the following additional muscles are assessed: shoulder abduction, elbow flexion and wrist extension.~The scores are then summed for each patient at each time point."|ICU and hospital discharge and change over time|This was an a priori subgroup analyses of patients who had mechanical ventilation duration >=7 days. Not all participants could be evaluated at each time point (e.g. cognitive status) and this explains the different sample sizes for each outcome.|||muscle strength score (higher is better)||Standard Deviation|Mean
2774450|NCT00709124|Secondary|ICU Delirium|Proportion of ICU days the patient had delirium|During ICU stay - on days with study (NMES/Sham) session||||Mean % delirious days|Days of session|Standard Deviation|Mean
2774451|NCT00709124|Secondary|Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline|"The mean change of the sum of the lower limb strength scores between awakening and ICU discharge and between ICU discharge and hospital discharge.~Three lower limb muscle groups are assessed bilaterally (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). The scores are then summed for each patient at each time point (range 0 -30, higher score is better)."|At ICU and Hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Score||Standard Deviation|Mean
2774452|NCT00709124|Secondary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)|Measured via manual muscle strength test using a composite Medical Research Council (MRC) score with each muscle group rated with score ranging from 0 (no visible or noticeable contraction of the muscle) to 5 (maximum strength). The sum of the scores for the lower limb muscle groups can range from 0 to 30 (higher score is better)|At hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Score||Standard Deviation|Mean
2776342|NCT00697593|Primary|Hematology - Hemoglobin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values|||g/L||Standard Deviation|Mean
2774458|NCT00709124|Secondary|Functional Status Measured Using Functional Status Score for the Intensive Care Unit|Evaluates a patient's physical function in the ICU setting. Each task is scored, ranging from 0 (unable to perform) to 7 (complete independence).The total score ranges from 0-35, with higher scores indicating better physical functioning.|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||FSS-ICU Score||Standard Deviation|Mean
2774459|NCT00709124|Secondary|Respiratory Muscle Strength|Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||% predicted||Standard Deviation|Mean
2774460|NCT00709124|Secondary|Hand Grip Strength|Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield % predicted)|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||% predicted||Standard Deviation|Mean
2774461|NCT00709124|Secondary|Overall Body Strength|Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Composite Score||Standard Deviation|Mean
2774462|NCT00709124|Secondary|Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength|Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||pounds||Standard Deviation|Mean
2774463|NCT00709124|Primary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score|Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups|At hospital discharge||||units (range 0-30; higher is better)||Standard Deviation|Mean
2774464|NCT00709111|Secondary|Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall|Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.|At weeks 4, 12, and 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.|||doses missed||Full Range|Median
2774465|NCT00709111|Secondary|Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)|A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.|At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36|As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.|||proportion of participants|||Number
2774466|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
2774467|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||ng/ml||90% Confidence Interval|Median
2774468|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||pg/ml||90% Confidence Interval|Median
2774469|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mg/dl||90% Confidence Interval|Median
2774470|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
2774471|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||ng/ml||90% Confidence Interval|Median
2774472|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||pg/ml||90% Confidence Interval|Median
2774475|NCT00709111|Secondary|Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||ng/ml||90% Confidence Interval|Median
2774476|NCT00709111|Secondary|Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||pg/ml||90% Confidence Interval|Median
2774477|NCT00709111|Secondary|Change in High Sensitivity C-reactive Protein (Hs-CRP)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mg/dl||90% Confidence Interval|Median
2774478|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
2774479|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
2774480|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mcg/ml||90% Confidence Interval|Median
2774481|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
2774482|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
2774483|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
2774484|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
2774485|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
2774486|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
2774500|NCT00709098|Primary|Patients With Adverse Events Leading to Premature Discontinuation of Study Drug|Number of patients with adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.||||participants|||Number
2774487|NCT00709111|Secondary|Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.|Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From baseline through week 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.|||participants|||Number
2774488|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
2774489|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
2774490|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.|||% of total lymphocytes/year||90% Confidence Interval|Mean
2774491|NCT00709111|Secondary|Within-subject CD4 Percentage Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.|||% of total lymphocytes/year||90% Confidence Interval|Mean
2774492|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
2774493|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
2774494|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
2774495|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.|||cells/mm^3/year||90% Confidence Interval|Mean
2774496|NCT00709111|Secondary|Within-subject CD4+ T-cell Count Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.|||cells/mm^3/year||90% Confidence Interval|Mean
2774497|NCT00709111|Secondary|Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count|Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.|||proportion of participants||90% Confidence Interval|Number
2774498|NCT00709111|Primary|Change in CD4+ T-cell Count|Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
2774501|NCT00709098|Primary|Adverse Events Leading to Premature Discontinuation of Study Drug|Number of adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|Safety population|||adverse events|||Number
2774502|NCT00709098|Primary|Treatment-emergent Serious Adverse Events|Number of serious adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population|||serious adverse events|||Number
2774503|NCT00709098|Primary|Treatment-emergent Adverse Events|Number of adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population|||adverse events|||Number
2774504|NCT00709059|Primary|Number of Study Participants Who Had a Virological Response (VR) at Week-72|"VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.~Participants who dropped out or were withdrawn from treatment were considered not to respond."|Treatment Week 72|Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.|||Participants|||Number
2774505|NCT00708942|Secondary|Incidence of Patients With Adverse Events||3 months|All patients treated|||percentage of no of patients analyzed|||Number
2774506|NCT00708942|Secondary|Eradication of HPV|High risk HPV|6 months|Patients who were positive for high risk HPV at baseline|||percentage of no. of patients analyzed|||Number
2774507|NCT00708942|Primary|Complete Response Rate|"Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV."|6 month|Per protocol population. Patients with major protocol violations excluded.|||percentage of no. of patients analyzed|||Number
2774508|NCT00708877|Primary|Transplant-related Mortality|Determined mortality-related transplant outcomes.|2 years|Entire cohort was used for analysis.|||participants|||Number
2774509|NCT00708851|Secondary|The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.|Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.|||participants|||Number
2774510|NCT00708851|Primary|The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.|Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.|||percent improvement from baseline||Full Range|Mean
2774511|NCT00708734|Primary|Gait and Balance Measures|Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.|5 months|The purpose of this pilot study was to evaluate the feasibilty of a structured, group exercise program in this population. Only 3 of 10 participants completed the study, due to high attrition, the project was considered unfeasible and data was not analysis.||||||
2774512|NCT00708721|Secondary|Number of Participants With Adverse Events|NCI CTCAE version 3.0 will be used to assess adverse events. The number of participants experiencing adverse events and the number of adverse events per patient will be documented through the course of study.|To 30 days after end of treatment or until full resolution.|All participants experienced at least 1 adverse event (100% of the patient population; 11/11 participants)|||participants experiencing adverse events|||Number
2774513|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on miRNA and mRNA Expression Patterns in Patients With MDS|Assessment of potential change in miRNA and mRNA genetic expression patterns in patients following administration of low dose daily clofarabine.|through end of treatment|Data were not collected and the outcome measure was not analyzed||||||
2774514|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on Global Methylation in Patients With MDS.|Potential genomic changes following low dose daily oral clofarabine administration will be assessed.|through end of treatment|Data were not collected and the outcome measure was not analyzed||||||
2774515|NCT00708721|Secondary|Response of MDS Patients Treated With Low Dose Daily Oral Clofarabine.|Stable disease is defined as failure to achieve at least PR, but no evidence of progression for > 8 weeks.|approximately 4 years|Of 11 patients, 9 were evaluable for response. Two patients had stable disease responses.|||Participants|||Count of Participants
2774516|NCT00708721|Secondary|Time to Progression to Acute Myeloid Leukemia (AML)|Longest documented duration of time until progression to AML.|approximately 4 years|Cycles are 28 days long. Analysis assessed the longest number of cycles completed on study until progression to AML.|||cycles|||Number
2774525|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, A drug-free interval reduces the risk for adverse drug reactions. Results are reported for participant's perception of risk of adverse drug reactions."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774517|NCT00708721|Primary|The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).|Response rate was measured as complete, partial and hematologic improvement by modified IWG criteria. For complete remission the following must be present for four weeks in a bone marrow aspirate and biopsy: <5% myeloblasts, normal maturation of all cell lines, persisted dysplasia. Peripheral blood counts need to be hemoglobin >11 g/dL, neutrophils >1000/mm3, platelets>100000/mm3, blasts 0%. Partial remission requires all criteria for complete remission except blasts decreased by >50% over pretreatment. Stable disease is defined as failure to achieve at least partial remission, but no evidence of progression for > 8 weeks. Failure is defined as death during tre3atment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment.|4 weeks|Two patients were not eligible for analysis.|||participants who experienced a response|||Number
2774518|NCT00708721|Primary|Number of Participants Who Experienced a Dose-Limiting Toxicity|Dose-limiting toxicity was defined as any nonhematologic toxicity grade 3 or greater except for alopecia or nausea (which may be of grade 4 severity), or any grade 4 hematologic toxicity lasting more than 28 days after the last day of therapy.|28 days after the first admistration of oral clofarabine|9 out of 11 participants were evaluable for this outcome.|||participants who experienced a DLT|||Number
2774519|NCT00708708|Secondary|Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.|Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)|Safety analysis set included all participants with available post-baseline safety data.|||participants|||Number
2774520|NCT00708708|Secondary|Criteria for Treatment Resumption|Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
2774521|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Recommendation of Therapy|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, Would you recommend therapy with Enbrel to other patients with plaque-psoriasis? Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points.|||participants|||Number
2774522|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Preference to Continuous Therapy|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, If possible, would you prefer a continuous therapy without drug-free interval? Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
2774523|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Comfort in Everyday Life|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, A drug-free interval means more comfort in my everyday life. Results are reported for participant's perception of comfort of life during the drug-free interval."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774524|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reminder of Disease|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, During drug-free interval I will not be reminded permanently of my disease. Results are reported for participant's perception of reminder of disease during the drug-free interval."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774622|NCT00708461|Primary|Change in Body Mass Index (BMI)|Assessed in kilograms per meter squared.|Baseline to 24 months|Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.|||kilograms per meter squared||Standard Error|Least Squares Mean
2774526|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, How much were you satisfied with the condition of your skin during the first half of the drug-free interval? and How much were you satisfied with the condition of your skin during the second half of the drug-free interval? Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval."|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774527|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Disease Activity|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, How would you assess the activity of your disease during the first half of the drug-free interval? and How would you assess the activity of your disease during the second half of the drug-free interval? Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval."|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774528|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval? After the drug-free interval participants were asked, To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval? Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774529|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Relapse of Symptoms|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, How much are you concerned about a relapse of symptoms? After the drug-free interval participants were asked, Were you concerned about a relapse of symptoms during the drug-free interval? Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774530|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Duration|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, How would you assess the length of the current drug-free interval? Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval."|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774531|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, Do you basically like the idea of a drug-free interval? After the drug-free interval participants were asked, How did you like the current drug-free interval? Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774532|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reason for Returning to Practice|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, Why did you return to the practice today? Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice."|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
2775307|NCT00705367|Primary|Short-term Period: Mean Respirations Rate|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||Respirations per minute||Standard Deviation|Mean
2774533|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Length of Drug-Free Interval|"A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, How long do you expect the drug-free interval to last for? After the drug-free interval participants were asked, How long did the drug-free interval last? Results are reported for participant's perception of the length of drug-free interval."|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||months||Standard Deviation|Mean
2774534|NCT00708708|Secondary|Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)|"Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n’=number of participants evaluable at the specified time points for the given cycles.|||units on a scale||Standard Deviation|Mean
2774535|NCT00708708|Secondary|Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score|"Effect of drug free interval on DLQI was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst)."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ’n’=number of participants evaluable at the specified time points for the given cycles.|||units on a scale||Standard Deviation|Mean
2774536|NCT00708708|Secondary|Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)|"Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2774537|NCT00708708|Secondary|Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications|Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Prior to study, Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.|||Euros||Standard Deviation|Mean
2774538|NCT00708708|Secondary|Average Cost of Treatment by Disease Severity|Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for the given disease severities.|||Euros||Standard Deviation|Mean
2774539|NCT00708708|Secondary|Annual Costs for Treatment With Etanercept|Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.|||Euros||Standard Deviation|Mean
2774540|NCT00708708|Secondary|Number of Participants With at Least 1 Concomitant Medication|Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.|Cycle 1 Week 0 up to Cycle 6 Week 24|Safety analysis set included all participants with available post-baseline safety data.|||participants|||Number
2774541|NCT00708708|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774542|NCT00708708|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774543|NCT00708708|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774544|NCT00708708|Secondary|Patient's Global Assessment of Disease Activity (PatGA)|Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774545|NCT00708708|Secondary|Percentage of Time on Treatment Over Entire Period|Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).|Cycle 1 up to Cycle 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of entire treatment period||Standard Deviation|Mean
2774546|NCT00708708|Secondary|Percentage of Time on Treatment in First Year|Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.|Year 1|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of first year||Standard Deviation|Mean
2774547|NCT00708708|Secondary|Cumulative Dose of Etanercept Per Year|Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure.|||mg||Standard Deviation|Mean
2774548|NCT00708708|Secondary|Number of Injections Per Year|Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure.|||injections||Standard Deviation|Mean
2774549|NCT00708708|Secondary|Patient Global Assessment of Efficacy|Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.|||participants|||Number
2774550|NCT00708708|Secondary|Physician Global Assessment of Efficacy|Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.|||participants|||Number
2777976|NCT00685295|Primary|Pain Reduction|Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).|60 minutes||||Participants|||Count of Participants
2774551|NCT00708708|Secondary|Static Physician Global Assessment (sPGA) of Disease Activity|Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774552|NCT00708708|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively.|||percentage of BSA||Standard Deviation|Mean
2774553|NCT00708708|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2774554|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 6|Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 5 Week 24 up to Cycle 6 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
2774555|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 5|Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 4 Week 24 up to Cycle 5 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
2774556|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 4|Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 3 Week 24 up to Cycle 4 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
2774557|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 3|Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 2 Week 24 up to Cycle 3 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
2774558|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 2|Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 1 Week 24 up to Cycle 2 Week 0|Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
2777977|NCT00685295|Primary|Time to Analgesia|Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)|60 minutes||||minutes||Inter-Quartile Range|Median
2774559|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
2774560|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of Infant Series (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
2774561|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
2774562|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
2774563|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
2774564|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
2774565|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
2774566|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
2774567|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.|Toddler Dose (12 months of age)|Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.|||mcg/mL||95% Confidence Interval|Geometric Mean
2774568|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 3 of infant series (6 months of age)|Evaluable 3-Dose Infant Immunogenicity population|||mcg/mL||95% Confidence Interval|Geometric Mean
2774569|NCT00708682|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 2 of infant series (4 months of age)|Evaluable 2-Dose Infant Immunogenicity population|||mcg/mL||95% Confidence Interval|Geometric Mean
2774570|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2774571|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after dose 2 of the infant series (5 months of age)|Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2774572|NCT00708682|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2774573|NCT00708643|Secondary|Corneal Staining|A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.||||units on a scale||Standard Error|Least Squares Mean
2774574|NCT00708643|Secondary|Tarsal Hyperemia|Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2774575|NCT00708643|Secondary|Tarsal Roughness|Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2774576|NCT00708643|Primary|Upper Lid Margin Staining|Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.|||units on a scale.||Standard Error|Least Squares Mean
2774577|NCT00708643|Primary|Lens Comfort|"Rating of lens comfort by rating agreement to the following statement:~The lenses I am wearing are comfortable.~Rating using the following scale:~1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames."|At 3,7,10,13,17,21,24, and 27 days|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2774578|NCT00708643|Primary|Limbal Hyperemia|Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
2774579|NCT00708552|Secondary|Exposure Estimates for Donepezil Average Concentration at Steady State (Cavgss)|Blood sample for pharmacokinetic analysis, were obtained within 24 hours of last dose. A total of five pharmacokinetic samples per participants were taken at Weeks 4, 8,12,18 and Week 24. The Donepezil exposures at steady state Cavgss for each participant were estimated via nonlinear mixed effect analysis. Data has been presented in a consolidated format for SB-742457 exposures at steady state Cavgss.|Weeks 4, 8,12,18 and Week 24|Pharmacokinetic concentration population. Only those participants with data available at the time of analysis were included.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2774580|NCT00708552|Secondary|Exposure Estimates for SB-742457 Minimum Concentration at Steady State (Cmin-ss)|Blood sample for pharmacokinetic analysis, were obtained within 24 hours of last dose. A total of five pharmacokinetic samples per participants were taken at Weeks 4, 8,12,18 and Week 24. The SB-742457 exposures at steady state Cmin-ss for each participant were estimated via nonlinear mixed effect analysis. Data has been presented in a consolidated format for SB-742457 exposures at steady state Cmin-ss.|One sample at Day 28±5, 56±5, 84±5, 126±5 and 168±5 post 24 hours of last dose|Pharmacokinetic concentration population. Only those participants with data available at the time of analysis were included.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2774581|NCT00708552|Secondary|Exposure Estimates for SB-742457 Area Under Curve Over the Dosing Interval at Steady State (AUCτss)|A total of five pharmacokinetic samples per participant were collected for the purpose of assessing plasma concentrations of SB-742457 and donepezil. At each visit (Day 28±5, 56±5, 84±5, 126±5 and 168±5) one sample was collected post 24 hours of last dose.|One sample at Day 28±5, 56±5, 84±5, 126±5 and 168±5 post 24 hours of last dose|Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the time of analysis were included.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2774582|NCT00708552|Secondary|Number of Participants With Electrocardiogram (ECG) Findings as Assessed by Investigator and Central Cardiologist|The clinical interpretation of the ECG by the investigator was recorded as Normal, Abnormal but not clinically significant (ANCS) and Abnormal clinically significant (ACS). ECG interpretation by the central cardiologist included the most extreme result of the available ECGs where the central cardiologist's interpretation of the ECG was recorded as Normal, Unable to Evaluate and Abnormal. Data has been presented for number of participants with most severe on-treatment abnormal ECG findings.|Upto Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2774583|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Red Blood Cell Count at Week 24|Hematology parameter included red blood cell count. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||trillion cells per liter||Standard Deviation|Mean
2774584|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Mean Corpuscle Volume and Mean Platelet Volume at Week 24|Hematology parameter included mean corpuscle volume and mean platelet volume. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
2774585|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin at Week 24|Hematology parameter included mean corpuscle hemoglobin. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||picograms||Standard Deviation|Mean
2774586|NCT00708552|Secondary|Change From Baseline in Hematology Parameters Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Week 24|Hematology parameter included hemoglobin and mean corpuscle hemoglobin concentration. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
2774587|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Hematocrit|Hematology parameter included hematocrit. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Ratio||Standard Deviation|Mean
2774588|NCT00708552|Secondary|Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, White Blood Cell Count at Week 24|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, white blood cell count. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||giga cells per liter||Standard Deviation|Mean
2774589|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Creatinine, Direct Bilirubin and Total Bilirubin at Week 24|Clinical chemistry parameters included creatinine, direct bilirubin and total bilirubin. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||umol/L||Standard Deviation|Mean
2774590|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Calcium, CO2 Content/Bicarbonate, Chloride, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphorus, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen at Week 24|Clinical chemistry parameters included calcium, CO2 content/bicarbonate, chloride, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphorus, potassium, sodium, triglycerides, urea/blood urea nitrogen. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
2774591|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameter Blood Urea Nitrogen /Creatinine Ratio at Week 24|Clinical chemistry parameter included blood urea nitrogen /creatinine ratio. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Ratio||Standard Deviation|Mean
2774592|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein at Week 24|Clinical chemistry parameters included albumin and total protein. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||grams per liter||Standard Deviation|Mean
2774593|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Week 24|Clinical chemistry parameters included alanine amino transferase, alkaline phosphatase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time point were analyzed.|||IU/L||Standard Deviation|Mean
2776268|NCT00698646|Secondary|Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])||During 16 weeks|Intent to treat (ITT)|||Weeks||95% Confidence Interval|Median
2774594|NCT00708552|Secondary|Number of Participants With Chemistry Data of PCC ATOT|Clinical chemistry parameters included alanine amino transferase international units per liter (IU/L) RR [0-48], alkaline phosphatase IU/L (20-125), aspartate amino transferase international units per liter (0-55), blood urea nitrogen/creatinine ratio (24-101), calcium millimoles per liter (mmol/L) [2.12-2.56], carbon dioxide content/bicarbonate mmol/L (20-32), cholesterol mmol/L (0.00-5.15), creatine kinase IU/L (males 0-235 and females 0-190), creatinine micromoles per liter (umol/L) [44-124], direct bilirubin umol/L (0-6), gamma glutamyl transferase IU/L (males 0-65 and females 0-45), glucose mmol/L (3.9-6.9), low density lipoprotein cholesterol mmol/L (0.00-3.35), lactate dehydrogenase IU/L (0-270), potassium mmol/L (3.5-5.3), sodium mmol/L (135-146), total bilirubin umol/L (0-22), triglycerides mmol/L (0.00-2.24), urea/blood urea nitrogen mmol/L (2.5-10.5). Data has been presented in a consolidated format for clinical chemistry parameters high and low from the RR of PCC ATOT.|Upto Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2774595|NCT00708552|Secondary|Number of Participants With Hematology Data of PCC ATOT|Hematology parameters included hematocrit ratio (reference range males 0.410-0.500, females 0.350-0.460 [18-64 years] and males 0.360-0.490, females 0.330-0.460 [65+ years]), hemoglobin grams per liter (13.8-17.2), lymphocytes giga per liter (0.85-4.10), monocytes giga per liter (0.20-1.10), platelet count giga per liter (130-400), segmented neutrophils giga per liter (1.80-8.00), total neutrophils (1.80-8.00). Data has been presented in a consolidated format for hematology parameters high and low from the reference range of PCC ATOT.|Upto Week 24|Safety population. Only those participants available at the specified time point were analyzed.|||Participants|||Number
2774596|NCT00708552|Secondary|Number of Participants With Vital Signs Data of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT)|Vital sign measurements included systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart Rate (HR), Body weight (BW). SBP and DBP and HR were measured once after the participant sat quietly for at least 5 minutes and in addition, upon standing to assess participants for postural hypotension. DBP was measured at the disappearance of Korotkoff sounds (Phase V). The plethysmographic method (preferably with a column sphygmomanometer where available) was used to measure blood pressure throughout the study. Body weight was measured, without shoes and wearing light clothing. The PCC range were as follows: SBP (Reference Range [RR] <90-140> Increase from Baseline [IFB]>=40 and decrease from baseline [DFB] >=30), DBP (RR < 50-90> IFB>=30 and DFB >=20), HR (RR <50-100> IFB >=30 and DFB >=30, BW (IFB >= 7% and DFB >=7%).|Upto Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Number
2774597|NCT00708552|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Number of participants with any adverse event (serious and non-serious) and SAEs were reported.|Upto Week 24|Safety population.|||Participants|||Number
2774598|NCT00708552|Secondary|Change From Baseline in ADCS-ADL-Basic Score; ADCS-ADL: Instrumental Score and ADCS-ADL: Total Independence Score at Weeks 12 and 24|Basic score was calculated as the sum of questions 1-6b and ranges from 0-22 (activities included are: eating, walking, using the toilet, bathing, grooming and dressing) and Instrumental score, sum of questions 7-23, ranges from 0-56 (activities included are: using the telephone, watching television, conversations, clearing dishes, personal belongings, making drinks, making snacks, taking rubbish out, getting out and about, shopping, keeping appointments, being left alone, current events, reading, writing, pastimes/hobbies, household chores). Total independence score is calculated by re-scoring the individual questions for each activity. The total independence score therefore ranges between 0 to 23, where 23 indicates that a participant is independent (based on these 23 ADL). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 12 and 24.|Baseline (Week 0) and Weeks 12 and 24|ITT population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774599|NCT00708552|Secondary|Change From Baseline in MMSE Total Score at Week 24|The MMSE is used to test for cognitive dysfunction. The scale is completed by a trained and experienced neurologist/psychiatrist/neuropsychologist based on the performance of the participants, and takes approximately 5 to 10 minutes to administer. It consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing, drawing across 5 sections (orientation, registration, attention-calculation, recall, and language). Scoring was done by circling 0 if the response was incorrect, or 1 if the response was correct. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better cognitive function. The total MMSE score was a sum of all item scores. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774623|NCT00708435|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.|The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.|||participants|||Number
2774600|NCT00708552|Secondary|Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) Total Score at Week 24|The CSDD is used to assess signs and symptoms of major depression in demented participants. The CSDD scale contains 19 items on mood-related signs of depression, behavioral disturbance, physical signs of depression, cyclic functions and ideational disturbances, where each item is rated for severity on a scale of 0-2 (0=absent, 1=mild/intermittent, 2=severe). Scores above 10 (probable major depression),scores above 18 (definite major depression), scores below 6 (absence of significant depressive symptoms). The total score was calculated as a weighted average of the scores provided for the remaining 18 questions as follows: Imputed Total= Observed Total Score x 1+ Maximum Score of the missing value/ Sum of the Maximum Score of the non -missing values) and ranges from 0-38. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774601|NCT00708552|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score at Weeks 12 and 24|The ADCS-ADL measures functional impairment in terms of activities of daily living. The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions (i.e. those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions) about the participant. The questions range from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signifies greater functional ability and lower scores indicating greater impairment. The total score is the sum of all items and sub-questions. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 12 and 24.|Baseline (Week 0) and Weeks 12 and 24|ITT population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774602|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 10-20.|Week 12|Intent-to-Treat (Baseline MMSE 10-20). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774603|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 16-26.|Week 12|Intent-to-Treat (Baseline MMSE 16-26). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774604|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 12|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 10-20. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|Intent-to-Treat (Baseline MMSE 10-20). Only those participants available at the specified time-points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774605|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 12|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for Participants with Baseline MMSE score 16-26. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|Intent-to-Treat (Baseline MMSE 16-26). Only those participants available at the specified time-points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2775308|NCT00705367|Primary|Short-term Period: Mean Heart Rate|Vital signs measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||beats per minute||Standard Deviation|Mean
2774606|NCT00708552|Secondary|Change From Baseline in RBANS Total Score at Week 12|RBANS is an individually administered neurocognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). The scale is completed by a trained and experienced neurologist, psychiatrist or neuropsychologist, or another trained and experienced person. It is preferred that this individual is the same person who administers the ADAS-Cog, but he/she must be a separate individual from the person who completes the CIBIC+. The scale is based on the performance of the participant and takes approximately 25-30 minutes to administer. Raw total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where low score= (greater impairment) and high score=(better cognitive function). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774607|NCT00708552|Secondary|CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).|Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774608|NCT00708552|Secondary|Change From Baseline in ADAS-Cog Total Score at Week 12|ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774609|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the CIBIC+ Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Higher scores indicate worst outcome. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with baseline MMSE 10-20. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 10-20). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774610|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the CIBIC+ Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 16-26. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 16-26). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774611|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline [MMSE Scores 10-20) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 24|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 10-20. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 10-20) which comprised of participants who had a baseline MMSE score of 16-26. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774624|NCT00708435|Secondary|45-Day All-cause Mortality||Until Day 45|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||participants|||Number
2774661|NCT00708214|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|First occurence or OR till progression or death|TS. Median duration of RECIST tumour response was not calculable as there was no OR observed.|||days||95% Confidence Interval|Median
2774612|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline Mini Mental State Examination [MMSE] Scores 16-26) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 24|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 16-26. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 16-26) which comprised of participants who had a baseline MMSE score of 16-26. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774613|NCT00708552|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24|RBANS is an individually administered neurocognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). The scale is completed by a trained and experienced neurologist, psychiatrist or neuropsychologist, or another trained and experienced person. It is preferred that this individual is the same person who administers the ADAS-Cog, but he/she must be a separate individual from the person who completes the CIBIC+. The scale is based on the performance of the participant and takes approximately 25-30 minutes to administer. Raw total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where low score= (greater impairment) and high score=(better cognitive function). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774614|NCT00708552|Primary|Clinician's Interview-Based Impression of Change - Plus (CIBIC+) Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).|Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774615|NCT00708552|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 24|ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Week 0. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2774616|NCT00708526|Secondary|Return of Cognitive Function|average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth|up to 30 minutes|number of participants determined by protocol|||minutes||Standard Deviation|Mean
2774617|NCT00708526|Primary|Recovery From Anesthesia|average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).|up to 2 hours||||minutes||Standard Deviation|Mean
2774618|NCT00708500|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.||At Follow-up Week 12 and at 72 weeks after randomization|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||participants|||Number
2774619|NCT00708500|Secondary|Number of Participants With Early Virologic Response.|Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.|At Week 2, 4, 8, or 12|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||participants|||Number
2774620|NCT00708500|Secondary|Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.|"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.~This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009."|At Follow-up Week 24|mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).|||Percentage of Participants|||Number
2774621|NCT00708500|Primary|Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.|SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.|At Follow-up Week 24|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||Percentage of Participants|||Number
2774625|NCT00708435|Secondary|Use of Other Blood Products and Hemostatic Agents|Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||Units of blood products||Standard Deviation|Mean
2774626|NCT00708435|Secondary|Transfusion of Red Blood Cells|Red blood cells were packed red blood cells (PRBCs).|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||Units of PRBCs||Standard Deviation|Mean
2774627|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After Randomization|The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
2774628|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
2774629|NCT00708435|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From preinfusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of normal||Standard Deviation|Mean
2774630|NCT00708435|Secondary|Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex|The incremental IVR [(IU/dL)/(IU/kg)] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = [maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)]/{[exact dose of component in drug administered (IU)]/[body weight (kg)]}.|Before infusion and up to 3 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||(IU/dL)/(IU/kg body weight)||Standard Deviation|Mean
2774631|NCT00708435|Secondary|Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding|"Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of excellent or good, and 'non-effective' was a hemostatic efficacy rating of poor/none."|At 3 and 6 hours after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
2774632|NCT00708435|Primary|Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)|A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after end of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
2774633|NCT00708435|Primary|Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed|"Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of excellent or good, and 'non-effective' was a hemostatic efficacy rating of poor/none."|At 1 and 4 hours after the end of infusion|The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
2774634|NCT00708422|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.|||Units on a scale||Standard Deviation|Mean
2774635|NCT00708422|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.|||seconds||Standard Deviation|Mean
2774636|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 4 hours post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
2774637|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 2 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
2774638|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 1 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
2774639|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 30 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
2774640|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 15 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
2774641|NCT00708305|Secondary|Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||ln(μg*F*minutes/cm^2)||Standard Error|Log Mean
2774642|NCT00708305|Primary|Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||ln(μg*F*minutes/cm^2)||Standard Error|Least Squares Mean
2774643|NCT00708227|Secondary|Bronchodilator Response Following Methacholine Challenge at Visit 4|The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had discontinued Advair for 36 hours.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Advair for 2 weeks at Visit 3.|||Liters*min||Standard Deviation|Mean
2774644|NCT00708227|Secondary|Bronchodilator Response Following Methacholine Challenge at Visit 3|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Advair for 2 weeks at Visit 3.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Advair for 2 weeks at Visit 3.|||Liters*min||Standard Deviation|Mean
2774645|NCT00708227|Secondary|Bronchodilator Response to Methacholine (PC20) After Visit 2|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Flovent for 2 weeks at Visit 2.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.|All participants who had received Flovent for 2 weeks at Visit 2.|||Liters*min||Standard Deviation|Mean
2774646|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 4|Visit 4 log10 PC20 to Methacholine after stopping Advair|36 hours after the last dose of Advair|All participants who had a methacholine challenge at Visit 4. All participants had discontinued Advair for 36 hours.|||log10 mg/mL||Standard Deviation|Mean
2774647|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 3|Visit 3 Log10 PC20 after receiving 2 weeks of Advair|Visit 3:12 hours after the last dose of Advair|All participants who had a methacholine challenge at Visit 3. All participants had received Advair for 2 weeks.|||log10 mg/mL||Standard Deviation|Mean
2774648|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 2|Visit 2 log10 PC20 after receiving 2 weeks of Flovent|Visit 2:12 hours after last dose of Flovent|All participants who had a methacholine challenge at Visit 2. All participants had received Flovent for 2 weeks.|||log10 mg/mL||Standard Deviation|Mean
2774649|NCT00708214|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1|baseline till end of treatment||||participants|||Number
2774650|NCT00708214|Secondary|Change From Baseline in Ca15.3|Change from baseline in Ca15.3 tumor marker levels|baseline and day 29|Analysis of all treatment arms combined for tumor marker analysis.|||percentage of baseline level||Full Range|Median
2774651|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||hours||Full Range|Median
2774652|NCT00708214|Secondary|Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2774653|NCT00708214|Secondary|Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2774654|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||hours||Full Range|Median
2774655|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)|Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.|Day 85|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2774656|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2774657|NCT00708214|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2774658|NCT00708214|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2774659|NCT00708214|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death.|Baseline till progression, death or data cut-off|TS. Estimation of median time to death was not feasible, due to the small number of patients who died during the trial.|||days||95% Confidence Interval|Median
2774662|NCT00708214|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|Baseline till progression|TS. Median time to RECIST tumour response was not calculable as there was no OR observed.|||days||95% Confidence Interval|Median
2774663|NCT00708214|Secondary|Number of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|16 weeks and 24 weeks|TS|||Participants|||Number
2774664|NCT00708214|Secondary|Number of Participants With Confirmed Objective Response (OR)|OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.|Baseline till progression|TS|||Participants|||Number
2774665|NCT00708214|Primary|Percentage of Progression Free Participants After 16 Weeks of Treatment|Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.|16 weeks|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
2774666|NCT00708201|Secondary|Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events|CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.|Baseline to 30 days post discharge|All participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2774667|NCT00708201|Secondary|Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points|DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.|||percentage of participants|||Number
2774668|NCT00708201|Secondary|Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points|Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.|||percentage of participants|||Number
2774669|NCT00708201|Secondary|Percentage of Participants With Postoperative Morbidity (POM)|POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.|During hospitalization or within 7 days after discharge|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.|||percentage of participants|||Number
2774670|NCT00708201|Secondary|Percentage of Participants Considered Postoperative LOS Responders|A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.|Day of surgery (Day 0) up to 7 days after surgery|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.|||percentage of participants|||Number
2774671|NCT00708201|Secondary|Postoperative Length of Stay (LOS)|The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).|Day of surgery (Day 0) to the day of hospital DOW|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.|||Days||Standard Deviation|Mean
2774672|NCT00708201|Secondary|Mean Time to Discharge Order Written (DOW) Using KM Estimates|"The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
2774687|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.|Week 48|ITT Analysis Set|||percentage of participants|||Number
2774688|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
2774673|NCT00708201|Secondary|Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model|"The endpoint of time to ready for discharge was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
2774674|NCT00708201|Primary|Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model|"Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|From day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
2774675|NCT00708175|Other Pre-specified|Number of Participants With Fracture|Number of participants with confirmed (through an adjudication process) fractures during the study. Circumstances surrounding the fracture, available X-ray and other diagnostic results and healing status were collected for the adjudication process.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||participants|||Number
2774676|NCT00708175|Other Pre-specified|Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM)|Participants were considered to have converted to T2DM if there were ≥2 consecutive post-Baseline FPG measurements ≥126 mg/dL. Participants meeting criteria were tabulated and summarized by Study Period (Treatment and Follow-up). Conversion to T2DM during Treatment Period occurred if either both of the consecutive post-Baseline high FPG values, or the first of the 2 consecutive high values occurred on or before the first day off study drug. Conversion to T2DM occurred during the Follow-up Period if both consecutive high values occurred after at least 1 day after the Treatment Period.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||participants|||Number
2774677|NCT00708175|Other Pre-specified|Change in Fasting Plasma Glucose (FPG)|The change between the fasting plasma glucose value collected at each time frame indicated.|Baseline and Month 12; Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||mg/dL||Standard Error|Least Squares Mean
2774678|NCT00708175|Secondary|Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA|The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray.|Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data.|||percent||Standard Error|Least Squares Mean
2774679|NCT00708175|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)|The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 12.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data. If a valid pre-treatment scan was not available, the earliest (within 30 days) post-dosing scan was used as Baseline. There was one such participant for this endpoint.|||percent||Standard Error|Least Squares Mean
2774680|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 96|The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.|||cells/mm^3||Standard Deviation|Mean
2774681|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.|||cells/mm^3||Standard Deviation|Mean
2774682|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 96|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2774683|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2774684|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set|||percentage of participants|||Number
2774685|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set|||percentage of participants|||Number
2774686|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set|||percentage of participants|||Number
2774736|NCT00708071|Secondary|Participants With Hematoma/Seroma During the Study|Investigators assessed each side of the face for the presence of hematoma/seroma|Through Postoperative Day 14 (± 1)|Per protocol|||participants|||Number
2774689|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
2774690|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
2774691|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
2774692|NCT00708162|Secondary|Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 96|ITT Analysis Set|||percentage of participants|||Number
2774693|NCT00708162|Secondary|Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 48|ITT Analysis Set|||percentage of participants|||Number
2774694|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set|||percentage of participants|||Number
2774695|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set|||percentage of participants|||Number
2774696|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set|||percentage of participants|||Number
2774697|NCT00708162|Primary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set|||percentage of participants|||Number
2774698|NCT00708123|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."|||µg*F/cm^2||Standard Error|Least Squares Mean
2774699|NCT00708123|Secondary|Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."|||%SMHR||Standard Error|Least Squares Mean
2774700|NCT00708123|Primary|Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the n per treatment group."|||%SMHR||Standard Error|Least Squares Mean
2774701|NCT00708110|Secondary|Number of Participants With the Emergence of Drug Resistance Mutations|The number of participants with the emergence (from Baseline) of drug resistance mutations at Day 11 was measured.|Baseline and Day 11|ITT(E) Population|||participants|||Number
2774737|NCT00708071|Secondary|Participants With Hematoma/Seroma|Investigators assessed each side of the face for the presence of hematoma/seroma|Days 0, 1, 3, 5, 7,10, and 14|Per Protocol|||Participants|||Number
2774702|NCT00708110|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11|Median change from Baseline in CD4+ cell count was calculated as the Day 11 value minus the Baseline value.|Baseline and Day 11|Per-Protocol Population: all participants included in the ITT(E) Population, excluding those who had at least one major protocol deviation|||Cells per cubic millimeter (cells/mm^3)||Full Range|Median
2774703|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population|||Log10 copies/mL||Standard Deviation|Mean
2774704|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population|||Log10 copies/mL||Full Range|Median
2774705|NCT00708110|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities|Clinical laboratory toxicities were graded according to the National Institutes of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented only for Grade 3 and Grade 4 laboratory abnormalities. Clinical laboratory abnormalities included: increased glucose, lipase, decreased platelets, and triglycerides.|Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21)|Safety Population|||participants|||Number
2774706|NCT00708110|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A 12-lead electrocardiogram (ECG) was performed by qualified personnel at the site after the participant had rested for at least 5 minutes in a semi-recumbent or supine position. If a QTc measurement of >=500 milliseconds (msec) was noted on a scheduled or unscheduled ECG, two additional ECGs were to be obtained within 5 minutes to confirm the abnormality. The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) ECG findings are presented here. The site determined if an ECG finding is significant or not. ECGs were obtained at Screening, Day 1 (pre-dose [twice] and then 1.0, 1.5, and 2.0 hours [hrs] post dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10 (pre-dose and then 1.0, 1.5, and 2.0 hrs post dose), Day 11 (prior to the 24 hr PK sample [pre lab]), and Follow-up.|Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21)|Safety Population. Only those participants who were available at the indicated time points were analyzed.|||participants|||Number
2774707|NCT00708110|Primary|Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10|Heart rate is the measure of heart beats per minute (bpm). Change in the mean heart rate from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population|||beats per minute||Standard Deviation|Mean
2774708|NCT00708110|Primary|Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10|Blood pressure measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Change in the mean blood pressure from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2774709|NCT00708110|Primary|Number of Participants Who Received the Indicated Concomitant Medications During the Study Period|"Concomitant medications received during the study period are presented by generic term. Only those concomitant medications that were received by at least two participants are presented. Multiple ingredient is the term used in the statistical package for items that contain more than one active ingredient."|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population. Only those participants who received a concomitant medication were analyzed.|||participants|||Number
2774710|NCT00708110|Primary|Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population: all participants who were randomized into the study with documented evidence of having received at least one dose of randomized treatment|||participants|||Number
2774711|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2774712|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analysed for the placebo group.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2774713|NCT00708110|Primary|Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10|tmax is defined as the time to the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||Hours||Full Range|Median
2774738|NCT00708071|Secondary|Total Volume of Drainage on Each Side of the Face||24 hours postoperative|Per Protocol|||mL||Full Range|Median
2774714|NCT00708110|Primary|Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration|C0 is defined as the pre-dose concentration. Ctau is defined as the concentration at the end of the dosing interval. Cmin is defined as the minimum observed concentration during one dosing interval. Cmax is defined as the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2774715|NCT00708110|Primary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-tau) is defined as the area under the concentration-time curve over the dosing interval. Blood samples for PK analysis of GSK1349572 were obtained on Day 10at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2774716|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2774717|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2774718|NCT00708110|Primary|Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1|tmax is defined as the time to the maximum obsevered plasma concentration. Absorption lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. tlag was estimated based on PK sampling times of 0 (pre-dose), 0.5, 1, 1.5, 2 3, 4, 6, 8, 12, and 24 hours post-dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Hours||Full Range|Median
2774719|NCT00708110|Primary|Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1|Cmax is defined as the maximum observed plasma concentration, and C24 is defined as the concentration at 24 hours post dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, Cmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed in the placebo group.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2774720|NCT00708110|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to24 hours. Blood samples for pharmacokinetic (PK) analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|Pharmacokinetic Summary (PKS) Population: participants (par.) with an evaluable profile of GSK1349572 on Day 10. Par. were excluded if they vomited within 2 hours of dosing on Day 10, missed more than one dose 2 days prior to Day 10, and took prohibited concomitant medication during the treatment period. No par. were analyzed in the placebo group.|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2774721|NCT00708110|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL|The number of participants who achieved plasma HIV-1 RNA levels <400 copies/mL and <50 copies/mL through Day 11 was measured.|Day 11|ITT(E) Population|||participants|||Number
2774722|NCT00708110|Secondary|Plasma HIV-1 RNA Rate of Decline Over 10 Days|The rate of decline of plasma HIV-1 RNA levels from Day 1 to Day 11 was measured.|Day 1 to Day 11|ITT(E) Population|||Log10 copies/mL/day||90% Confidence Interval|Mean
2774723|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population|||Log10 copies/mL||Full Range|Median
2774724|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population|||Log10 copies/mL||Standard Deviation|Mean
2774725|NCT00708110|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11|Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).|Baseline (Day 1) and Day 11|Intent to Treat Exposed (ITT[E]) Population: all participants who met study criteria and were randomized into the study with documented evidence of having received at least one dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement|||Log10 copies/milliliter (log10 copies/mL||Standard Deviation|Mean
2774726|NCT00708097|Secondary|Enamel Fluoride Uptake (Demineralized Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.|||μg*F/cm^2||Standard Error|Least Squares Mean
2774727|NCT00708097|Secondary|Enamel Fluoride Uptake (Sound Enamel Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.|||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Least Squares Mean
2774728|NCT00708097|Secondary|Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
2774729|NCT00708097|Secondary|Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
2774730|NCT00708097|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
2774731|NCT00708071|Primary|Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period||Through Postoperative Day 14 (± 1)|Safety Data Set|||Adverse Events|||Number
2774732|NCT00708071|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)|Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
2774733|NCT00708071|Secondary|Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol|||Scores on a scale||Full Range|Median
2774734|NCT00708071|Secondary|Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol|||Scores on a scale||Full Range|Median
2774735|NCT00708071|Secondary|Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14|Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points|Postoperative Days 3, 7, 10, and 14|Per protocol|||mm||Full Range|Median
2774741|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774742|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774743|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774744|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774745|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774746|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2775036|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.|One-month post-vaccine||||Titers||Full Range|Geometric Mean
2774747|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774748|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774749|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774750|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774751|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774752|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.~Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774753|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3|"Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Postoperative Day 3|Per Protocol|||Scores on a scale||Full Range|Median
2774760|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 14|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 14|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
2774754|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774755|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774756|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774757|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774758|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2774759|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
2775054|NCT00706446|Secondary|Exhaled NO (Nitric Oxide)||1 year|Data was not collected for secondary outcomes due to study termination.||||||
2775055|NCT00706446|Secondary|FEV1 (Forced Expiratory Volume)||1 year|Data was not collected for secondary outcomes due to study termination||||||
2774761|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 10|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 10|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
2774762|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 7|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 7|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
2774763|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 5|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 5|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
2774764|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 1|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 1|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
2774765|NCT00708071|Primary|Visual Comparison of Ecchymosis at Postoperative Day 3|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 3|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
2774766|NCT00708032|Primary|Papillary Conjunctivitis|Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.|12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
2774767|NCT00708032|Secondary|Subjective Overall Vision After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
2774768|NCT00708032|Secondary|Subjective Overall Comfort After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
2774769|NCT00708032|Secondary|Visual Acuity After 12 Months of Wear|Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||logMar||Standard Deviation|Mean
2774770|NCT00708032|Secondary|Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.|Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
2774771|NCT00708019|Secondary|Worst Pain Intensity Score|"Worst pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in worst pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks||||units on a scale||95% Confidence Interval|Mean
2774772|NCT00708019|Primary|Average Pain Intensity Score|"Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks||||units on a scale||95% Confidence Interval|Mean
2774773|NCT00707993|Secondary|Incidence of Glycosylated Hemoglobin Decrease From Baseline.|The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percentage of participants|||Number
2774774|NCT00707993|Secondary|Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%|The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percentage of participants|||Number
2774775|NCT00707993|Secondary|Change From Baseline in High Sensitivity C-reactive Protein|The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/L||Standard Error|Least Squares Mean
2774776|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Triglycerides)|The change in triglycerides measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2774777|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)|The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2774778|NCT00707993|Secondary|Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)|The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2774779|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Total Cholesterol)|The change in total cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2774780|NCT00707993|Secondary|Change From Baseline in Body Weight|The change in body weight measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||kg||Standard Error|Least Squares Mean
2774781|NCT00707993|Secondary|Homeostasis Model Assessment of Beta Cell Function|The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percent score of beta cell function||Standard Error|Least Squares Mean
2774782|NCT00707993|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||ratio||Standard Error|Least Squares Mean
2774783|NCT00707993|Secondary|Change From Baseline in Insulin|The change between the value of insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mcIU/mL||Standard Error|Least Squares Mean
2774784|NCT00707993|Secondary|Change From Baseline in Fasting Proinsulin|The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
2774785|NCT00707993|Secondary|Change From Baseline in 2-hour Postprandial Glucose|The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set).|||mg/dL||Standard Error|Least Squares Mean
2774786|NCT00707993|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2774787|NCT00707993|Secondary|Incidence of Hyperglycemic Rescue|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.|||participants|||Number
2774788|NCT00707993|Secondary|Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).|The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set).|||participants|||Number
2774789|NCT00707993|Secondary|Incidence of Hypoglycemia|Percentage of participants with at least one hypoglycemic episode during 52 week study.|On occurrence (up to 52 weeks).|Percentages based on the number of Safety Set participants in each treatment group.|||percentage of participants|||Number
2774790|NCT00707993|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2774791|NCT00707993|Primary|Change From Baseline in Glycosylated Hemoglobin at Week 52.|The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2775056|NCT00706446|Primary|Number of Patients With Asthma Exacerbation||1 year||||Participants|||Count of Participants
2774792|NCT00707980|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 52|Safety set with available data|||participants|||Number
2774793|NCT00707980|Secondary|Change From Baseline to the Final Visit in the Sheehan Disability Scale|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.|||scores on a scale||Standard Deviation|Mean
2774794|NCT00707980|Secondary|Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.|||scores on a scale||Standard Deviation|Mean
2774795|NCT00707980|Secondary|Change From Baseline in the Clinical Global Impression of Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
2774796|NCT00707980|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
2774797|NCT00707980|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
2774798|NCT00707980|Secondary|Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
2774799|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.|Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52|Safety set|||participants|||Number
2774800|NCT00707980|Primary|Number of Participants With Adverse Events (AEs)|"The intensity (severity) of each AE was defined as:~Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.~Moderate: sufficiently uncomfortable to produce some impairment of normal activities.~Severe: incapacitating, preventing the patient from participating in normal activities.~The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion."|From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)|Safety set|||participants|||Number
2774801|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.|Weeks 4, 12, 24, 36 and 52|Safety set|||participants|||Number
2774802|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|Safety set|||participants|||Number
2774803|NCT00707980|Primary|Physical Examination Findings|"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.~Each system was assessed as normal or abnormal."|Baseline and Week 52|The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.|||participants|||Number
2774804|NCT00707967|Secondary|Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes|Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.|From Day 60 to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774805|NCT00707967|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2774806|NCT00707967|Secondary|Cell Count of CD4+ T Cells|CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.|At Day 0, 30, 60 and 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||T cells/cubic millimeter||Inter-Quartile Range|Median
2774807|NCT00707967|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
2774808|NCT00707967|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
2774809|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774810|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774811|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774812|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774813|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774814|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774815|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774816|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774817|NCT00707967|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774818|NCT00707967|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity|During the entire study period, from Day 0 up to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774819|NCT00707967|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774820|NCT00707967|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774821|NCT00707967|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2774822|NCT00707954|Secondary|Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin||18 days|||||||
2774823|NCT00707954|Secondary|Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr||19 days|||||||
2774824|NCT00707954|Primary|Safety: Adverse Events, Adverse Drug Reactions|In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.|19 days||||percentage of incidences|||Number
2774825|NCT00707915|Secondary|Clinical Global Impression (CGI)|The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8.|Week 8||||units on a scale||Standard Deviation|Mean
2774826|NCT00707915|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)|The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8.|Week 8||||units on a scale||Standard Deviation|Mean
2774827|NCT00707915|Secondary|Critical Flicker Fusion Test (CFF)|The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded.|Baseline and week 8||||Hz||Standard Deviation|Mean
2774828|NCT00707915|Secondary|Clinical Stabilometric Platform (CSP)|CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded.|Baseline and week 8||||cm||Standard Deviation|Mean
2774829|NCT00707915|Secondary|A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.|This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure.|Baseline and week 8||||units on a scale||Standard Deviation|Mean
2774830|NCT00707915|Primary|Completion Rate|The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects|8 weeks||||percentage of successful completers|||Number
2774831|NCT00707863|Primary|17-item Hamilton Depression Rating Scale (HAM-D)|Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2774832|NCT00707759|Secondary|Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy||12 months|||||||
2774833|NCT00707759|Primary|Stimulation of Growth After 12 Months (Delta Z-score)||12 months||||units on a scale||Standard Deviation|Mean
2774834|NCT00707746|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774835|NCT00707746|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774836|NCT00707746|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774837|NCT00707746|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774838|NCT00707746|Other Pre-specified|Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||ratio||Standard Deviation|Mean
2774839|NCT00707746|Other Pre-specified|Percent Change From Baseline in the Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774840|NCT00707746|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774841|NCT00707746|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2776269|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)|Cumulative refers to achieving blood pressure goal before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)|||Percentage of Participants|||Number
2774842|NCT00707746|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774843|NCT00707746|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774844|NCT00707746|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774845|NCT00707746|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774846|NCT00707746|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774847|NCT00707746|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774848|NCT00707746|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774849|NCT00707746|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774850|NCT00707746|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2774851|NCT00707746|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Inter-Quartile Range|Median
2774852|NCT00707746|Primary|Summary of Participants With Adverse Events|"The on-treatment time frame spanned the time during which the study drug was administered until the later of the primary efficacy time point and 14 days beyond the last study drug date.~Adverse events (AEs) were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug.~Severity was assessed as:~Mild-symptom barely noticeable to the patient or do not make the patient uncomfortable;~Moderate-symptom makes the patient uncomfortable, affects performance of daily activities;~Severe-symptom causes the patient severe discomfort, may cause cessation of treatment with the study drug.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Pre-treatment (prior to first dose), On-treatment (Day 1 to week 28), Post-treatment (Week 28-52)|Safety set of all randomized participants who received at least one injection of study drug.|||participants|||Number
2774853|NCT00707746|Primary|Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
2774854|NCT00707746|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
2774855|NCT00707655|Secondary|Tumor Response Rate/ Complete or Partial Response||2 years||||participants|||Number
2774856|NCT00707655|Secondary|Best Overall Tumour Response|Best overall tumor response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|2 years||||participants|||Number
2774857|NCT00707655|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.|Overall study||||participants|||Number
2774858|NCT00707577|Primary|Weight Loss|Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program|1 year||||pounds||Standard Deviation|Mean
2774859|NCT00707486|Secondary|Incidence of Post Surgical Sequelae||1 week post surgery||||Percent of Participants|||Number
2774860|NCT00707486|Primary|Time to Hemostasis|This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.|Minutes After Application|Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.|||Minutes|Participants|Standard Error|Mean
2774861|NCT00707447|Secondary|Emotional Well-being/ Depression (CES-D)|"The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from 0 to 3. Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state.~Mean change in depression score (CES-D) after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
2774862|NCT00707447|Secondary|Psychological Well-being (WHO-5)|"The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being.~Mean change in psychological well-being score (WHO-5) after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
2774863|NCT00707447|Secondary|Eating Behavior (TFEQ) - Hunger|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale hunger consists of 14 Item with a minimum score of 0 and a maximum score of 14. Low scores indicate an eating behavior strongly depending on feelings of hunger.~Mean change in the TFEQ - hunger scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
2774864|NCT00707447|Secondary|Eating Behavior (TFEQ) - Disinhibition|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale disinhibition consists of 16 Item with a minimum score of 0 and a maximum score of 16. High scores indicate an uninhibited eating behavior strongly depending on external cues.~Mean change in the TFEQ - disinhibition scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
2774865|NCT00707447|Secondary|Eating Behavior (TFEQ) - Cognitive Restraint|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale cognitive restraint consists of 21 Item with a minimum score of 0 and a maximum score of 21. Low scores indicate an uninhibited eating behavior.~Mean change in the TFEQ - cognitive restraint scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
2774866|NCT00707447|Secondary|Physical Exercise|Mean changes in physical exercise (in min/week) after 12 months|12 months||||minutes per week||Standard Deviation|Mean
2774867|NCT00707447|Secondary|Glucose Tolerance|Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months|12 months||||mg/dl||Standard Deviation|Mean
2774868|NCT00707447|Secondary|Fasting Glucose|Mean changes in fasting glucose (in mg/dl) after 12 month|12 months||||mg/dl||Standard Deviation|Mean
2774869|NCT00707447|Primary|Waist Circumference|Mean change in waist circumference (in cm) after 12 months|12 months||||cm||Standard Deviation|Mean
2774870|NCT00707447|Primary|Weight Change|Mean weight change (in kg) after 12 months|12 month|Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures|||kg||Standard Deviation|Mean
2774880|NCT00707239|Other Pre-specified|Clearance (CL) of Tigecycline|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of serum from which drug can be completely removed per unit of time.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter/hr||95% Confidence Interval|Mean
2774871|NCT00707434|Primary|Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing|"Mean relative difference will be calculated on a patient level assuming that at least 6 paired measurements will be collected from each patient.~Outcome represents reliability of CGM device as compared with POC glucose testing where glucose values measured by POC will only be compared with the values read by the continuous glucose monitor sensor at the corresponding time points. The primary outcome for each patient is the mean relative difference defined as average of relative difference at each time point, where relative difference at each time point is calculated by taking difference in glucose values between CGM and POC and then divided by POC glucose value."|Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.|Study was terminated due to insufficient funding and data were not collected.||||||
2774872|NCT00707343|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques|"The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis.~Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax)."|30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation||||Probability||95% Confidence Interval|Number
2774873|NCT00707239|Other Pre-specified|Duration of Intravenous Antibiotic Treatment, Hospital and Intensive Care Unit (ICU) Stay||Baseline up to Day 44 (30 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable for intravenous antibiotic treatment, hospital or ICU stay for each reporting group respectively.|||days||Full Range|Median
2774874|NCT00707239|Other Pre-specified|Time to Reach Half of the Maximum Observed Plasma Concentration and Time to Normalization of Concentrations (Tnorm) of Procalcitonin||Baseline up to Day 6|Data was not analyzed because there was no apparent change in procalcitonin concentration over time.|||hr||Full Range|Median
2774875|NCT00707239|Other Pre-specified|Maximum Observed Plasma Concentration of Procalcitonin (Cmaxpd) and Predicted Procalcitonin Plasma Concentration at 24 Hours (Cpd,24) and 48 Hours (Cpd,48)||Baseline up to Day 6|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2774876|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Microbiological Outcome|Microbiological response:Eradication=baseline isolate not present in repeat culture from original infection site;Presumed Eradication=clinical response of cure precluded availability of specimen for culture;Persistence=baseline isolate present in repeat culture from original infection site;Presumed Persistence=culture data not available for participants with clinical response of failure;Superinfection=culture from primary infection site had new pathogen not identified as baseline isolate, clinical response was failure. MIC=lowest drug concentration with no visible growth of microorganism.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Data was not analyzed because correlation analysis could not be performed due to insufficient number of participants for whom data for both microbiological outcomes and tigecycline concentration was available.|||ratio||Standard Deviation|Mean
2774877|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Clinical Outcome|Clinical response:Cure =Initial SSx improved;CXR improved/stable;no other antibiotic for pneumonia;no worsening/new SSx. Failure=Persistence/worsening SSx;no clinical improvement/initial improvement with worsening; other antibiotic;CXR progression;death >study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reason;death in 2 days after dose 1 for any reason or >2 days but before TOC visit for non-pneumonia reason. MIC=lowest drug concentration with no visible growth of microorganism. AUC(0-24)/MIC:reported for cure and failure/indeterminate.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2774878|NCT00707239|Other Pre-specified|Correlation of AUC (0-24) of Tigecycline With Nausea and Vomiting|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population PK analysis by using each participant's dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Baseline up to Day 29 to 35 (15 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*hr/mL||Standard Deviation|Mean
2774879|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Tigecycline|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant's dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*hr/mL||Standard Deviation|Mean
2774921|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At any point during the study|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
2774881|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Tigecycline|AUC (0-12) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant's dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
2774882|NCT00707239|Other Pre-specified|Time to Reach Maximum Observed Serum Concentration (Tmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hrs||Full Range|Median
2774883|NCT00707239|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2774884|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Potentially clinically significant ECG data: Non-first values greater than 240 millisecond (msec) with increase of greater than or equal to 10 percent (%) from baseline for PR interval; Non-first values greater than or equal to 120 msec for QRS interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for corrected QT (QTc) interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for QTc using Framingham formula (QTc F).|Baseline up to Day 14 or LDOT|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2774885|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Laboratory Examinations|Participants were evaluated for following laboratory parameters: albumin, alkaline phosphatase, amylase, urea (blood urea nitrogen [BUN]), total bilirubin, calcium, magnesium, carbon dioxide, international normalized ratio (INR), chloride, creatinine, glucose, lipase, potassium, phosphorus, aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, total protein, hemoglobin, hematocrit, white blood cells, eosinophils, neutrophils, lymphocytes, platelets, prothrombin time, prothrombin activity and partial thromboplastin time.|Baseline up to Day 24 to Day 35 (10 to 21 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2774886|NCT00707239|Other Pre-specified|Number of Participants Who Experienced Nausea or Vomiting||Baseline up to Day 29 to Day 35 (15 to 21 days after LDOT)|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2774887|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure precluded the availability of a specimen for culture; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure; Superinfection = culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|Up to Day 24 to 35 (10 to 21 days after LDOT)|ME population included participants who met specified evaluability criteria for efficacy, had culture taken from the infected site before first dose of study medication and had at least 1 pathogen, and at least 1 baseline pathogen was susceptible to tigecycline and imipenem/cilastatin regimens.|||percentage of participants|||Number
2774888|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit|Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for participants with a clinical response of failure; Indeterminate=unable to determine outcome for non-study drug/infection reasons; no baseline isolate; death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Microbiologically Evaluable (ME) population:participants who met evaluability criteria for efficacy, had culture taken from infected site before dose 1 of study drug, had at least (>=)1 pathogen, >=1 pathogen was susceptible to tigecycline, imipenem/cilastatin regimen; ‘n’ = those participants who had specified pathogen for each group respectively.|||percentage of participants|||Number
2774889|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. 'n' is signifying those participants who were evaluable for this measure and included in VAP (suffering from VAP) and non-VAP group (not suffering from VAP) for each group respectively.|||percentage of participants|||Number
2774922|NCT00706979|Primary|A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
2774890|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|c-mITT population included all participants who were randomly assigned to receive intravenous study medication and had clinical evidence of hospital-acquired pneumonia (HAP).|||percentage of participants|||Number
2774891|NCT00707239|Primary|Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR) improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT])|CE population included those participants who met specified evaluability criteria for efficacy.|||percentage of participants|||Number
2774892|NCT00707174|Primary|The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants|Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.|24 months|All evaluable patients from both groups were compared|||participants|||Number
2774893|NCT00707161|Primary|Response Rate of Melanoma Lesions|Response rate of melanoma lesions was measured after treated with the trial agent.|2005-2010|Study terminated. Analysis not conducted.||||||
2774894|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 4|"Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 48 hours or at time of rescue between 36 and 48 hours.|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2774895|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 3|"Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 36 hours or at time rescue between 24 and 36 hours|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
2774896|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 2|"Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 24 hours or at time of rescue between 12 and 24 hours|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2774897|NCT00707057|Secondary|Global Evaluation for Dose 1|"Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command:~Select the number that best describes how you would rate this medication as a pain-reliever (select one number only). The range went from 0 (Very poor) to 10 (Excellent)."|At 12 hours after Dose 1 or at time of rescue|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2774898|NCT00707057|Secondary|Pain Relief and PID Scores at Individual Time Points for Dose 1|Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement)|24, 36, 48 hours after taking Dose 1|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2774899|NCT00707057|Secondary|Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1|Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.|0-12 hours after taking Dose 1|Intention to treat (ITT)|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2774900|NCT00707057|Secondary|Duration of Relief After Dose 1|Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time.|Time to rescue or time of Dose 2 (up to 12 hours following dose 1)|Intention to treat (ITT)|||Minutes||Full Range|Median
2774923|NCT00706966|Secondary|Testosterone Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||ng/dL||Standard Deviation|Mean
2774901|NCT00707057|Secondary|Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)|The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived.|0-12 hours after Dose 1|Intention to treat (ITT)|||Time weighted units on a scale||Standard Deviation|Mean
2774902|NCT00707057|Secondary|"Percentage of Subjects Achieving Meaningful Relief as Indicated by the Time Recorded on the Second Stopwatch Following First Perceptible Relief"|"Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both first perceptible relief and meaningful relief within the time allotted. The assigned censored time for No Pain Relief is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain"|Within 4 hours post Dose 1|Intention to treat (ITT)|||Percent of participants||95% Confidence Interval|Number
2774903|NCT00707057|Secondary|Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1|"Percentage (percentage of total) of subjects with first perceptible relief within 1 hour of Dose 1. The assigned censored time for No Pain Relief was 240 minutes."|Within 1 hour of Dose 1|Intention to treat (ITT)|||Percent of participants||95% Confidence Interval|Number
2774904|NCT00707057|Secondary|"Time to Confirmed Meaningful Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed meaningful relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both initial and meaningful relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain."|Within 4 hours post Dose 1|Intention to treat (ITT)|||Minutes||Full Range|Median
2774905|NCT00707057|Secondary|"Time to Confirmed First Perceptible Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for No Pain Relief is 240 minutes."|Within 4 hours post Dose 1|Intention to treat (ITT)|||Minutes||Full Range|Median
2774906|NCT00707057|Primary|Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours|Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.|24, 36, and 48 hours|Intention to treat (ITT)|||participants|||Number
2774907|NCT00707057|Primary|Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale|"Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID).~An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation."|from baseline to 12 hours after dose 1|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2774908|NCT00707031|Other Pre-specified|Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24|PAGI-QOL: a 30-item self-administered questionnaire to measure health related QOL of patients with upper gastrointestinal disorders during past 2 weeks. Consists of 5 sub-scales. Each item rated on a 0-5 point Likert scale (0 [none of the time] to 5 [all the time]). Sub-scale score calculated by dividing sum of all items of subscale by number of items in the sub-scale. Total score calculated by taking mean of sub-scale scores. Sub-scale score and total score ranges from 0=none of the time (lowest score) to 5=all of the time (highest score) with lower scores indicating better QOL. The on-treatment period for this variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PAGI-QOL assessment during on-treatment period.|||units on a scale||Standard Error|Least Squares Mean
2774909|NCT00707031|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks|Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2774924|NCT00706966|Secondary|Dihydrotestosterone (DHT) Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||ng/dL||Standard Deviation|Mean
2774910|NCT00707031|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2774911|NCT00707031|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2774912|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2774913|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2774914|NCT00707031|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2774915|NCT00707031|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2774916|NCT00707031|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute Change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2774917|NCT00706992|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years||||Participants|||Number
2774918|NCT00706992|Primary|Percentage of Participants With Immunologic Response|Percentage of participants with an immunologic response of >20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.|9/24/08-10/9/12|Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.|||Percentage of participants|||Number
2774919|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At 6-month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
2774920|NCT00706979|Primary|A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
2774926|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - SQLI|The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
2774927|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - FACE|Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
2774928|NCT00706966|Secondary|Symptom Indices Over Time - IIEF-5|The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
2774929|NCT00706966|Secondary|Symptom Indices Over Time - IPSS|IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).|Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
2774930|NCT00706966|Secondary|Adverse Events Indicative of Safety of Dutasteride|Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.|Baseline, 1, 3, and 6 months||||adverse events|||Number
2774931|NCT00706966|Primary|Change in Extent of Cancer|Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.|1 month, 6 months|One participant withdrew from the study|||participants|||Number
2774932|NCT00706914|Other Pre-specified|Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)|FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
2774933|NCT00706914|Other Pre-specified|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
2774934|NCT00706914|Other Pre-specified|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
2774935|NCT00706914|Primary|Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores|Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Units on a scale||95% Confidence Interval|Mean
2774936|NCT00706914|Primary|Change From Baseline in Weekly Average Nocturnal Symptom Scores|Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Units on a scale||95% Confidence Interval|Mean
2774937|NCT00706901|Secondary|Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Days of drug use||Standard Deviation|Mean
2775150|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12||12 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
2774938|NCT00706901|Primary|Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Number of 12-step sessions attended||Standard Deviation|Mean
2774939|NCT00706901|Primary|Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Number of treatment sessions||Standard Deviation|Mean
2774940|NCT00706901|Primary|Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Standard alcohol drinks||Standard Deviation|Mean
2774941|NCT00706901|Primary|Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)|||Days of binge drinking||Standard Deviation|Mean
2774942|NCT00706901|Primary|Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)|||Days Using Alcohol||Standard Deviation|Mean
2774943|NCT00706849|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
2774944|NCT00706849|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
2774945|NCT00706849|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2774946|NCT00706849|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
2774947|NCT00706849|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||ratio||Inter-Quartile Range|Median
2774948|NCT00706849|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
2774949|NCT00706849|Other Pre-specified|Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
2774963|NCT00706836|Primary|Effect of Pregabalin (Two Doses) Versus Placebo|Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.|Week 1, 2, 3 (Cross-over Design)|Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.|||% signal change L amygdala + anticipn||Standard Error|Mean
2774950|NCT00706849|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
2774951|NCT00706849|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
2774952|NCT00706849|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
2774953|NCT00706849|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
2774954|NCT00706849|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
2774955|NCT00706849|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2774956|NCT00706849|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
2774957|NCT00706849|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2774958|NCT00706849|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
2774959|NCT00706849|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2774960|NCT00706849|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
2774961|NCT00706849|Primary|LDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2774962|NCT00706849|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of Baseline||Standard Deviation|Mean
2774965|NCT00706823|Secondary|Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization|When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.|after intubation|Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure.|||participants|||Number
2774966|NCT00706823|Primary|Leak Pressure|After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.|duration of intubation||||cm of H2O||Standard Deviation|Mean
2774967|NCT00706823|Secondary|Number of Participants With Oropharyngeal Discomfort|Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.|post operative, immediately and 24 hrs after intubation||||participants|||Number
2774968|NCT00706823|Secondary|Level of Difficulty for Intubation|Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).|duration of intubation||||participants|||Number
2774969|NCT00706823|Primary|Time Required for Intubation|The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).|duration of intubation||||seconds||Standard Deviation|Mean
2774970|NCT00706810|Secondary|Median Progression-free Survival Rates of the Treatment Population.|Response and progression will be evaluated in this study using measurements from the MRI/CT scans. Measurements will be made of the image slice with the largest cross sectional area. Two orthogonal measures will be made to determine maximal AP and lateral dimensions. Progression of disease will be defined as a greater than 25% increase of largest cross sectional area by two orthogonal measurements, taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|31 months||||months||Full Range|Median
2774971|NCT00706810|Primary|Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.|Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.|two years||||participants|||Number
2774972|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on scale||Standard Deviation|Mean
2774973|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health Index|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on scale||Standard Deviation|Mean
2774974|NCT00706797|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)|Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774975|NCT00706797|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)|Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 12, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774976|NCT00706797|Secondary|Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period|Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||mg||Standard Deviation|Mean
2774977|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 90% (ACR90) Response|American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774978|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|American College of Rheumatology 70% (ACR70) response: responder = ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774979|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|American College of Rheumatology 50% (ACR50) response: responder = ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774980|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|American College of Rheumatology 20% (ACR20) response: responder = ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774981|NCT00706797|Secondary|Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria|Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774982|NCT00706797|Secondary|Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant's assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774983|NCT00706797|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774984|NCT00706797|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.60)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774985|NCT00706797|Secondary|Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
2774986|NCT00706797|Secondary|Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52|Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52, Last observation carried forward (LOCF)|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants||95% Confidence Interval|Number
2774987|NCT00706797|Secondary|Change From Baseline in Joint Space Narrowing at Week 52|Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
2774988|NCT00706797|Secondary|Change From Baseline in Erosions at Week 52|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
2775151|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24||24 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
2774989|NCT00706797|Primary|Change From Baseline in Modified Total Sharp Score (TSS) at Week 52|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|Modified intent-to-treat (mITT) population including all participants with an erosion at randomization confirmed by the blinded expert assessor, received at least 1 dose of subject treatment, and had data for randomization and 1 post randomization X-ray. Efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
2774990|NCT00706784|Primary|Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion||8 hours||||pg/ml||Standard Deviation|Mean
2774991|NCT00706719|Secondary|Follicle Stimulating Hormone (FSH) Levels|FSH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mIU/mL||Standard Deviation|Mean
2774992|NCT00706719|Secondary|Luteinizing Hormone (LH) Levels|LH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mIU/mL||Standard Deviation|Mean
2774993|NCT00706719|Primary|Semen Volume|Semen volume was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mL||Standard Deviation|Mean
2774994|NCT00706719|Primary|Motile Total Sperm Count|Motile total sperm count was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||millions sperm||Standard Deviation|Mean
2774995|NCT00706719|Primary|Sperm Concentration|Total sperm concentration was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||millions sperm/mL||Standard Deviation|Mean
2774996|NCT00706706|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)|Safety population included those participants who had taken at least one dose of the study drug.|||Percent chance of survival||95% Confidence Interval|Number
2774997|NCT00706706|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.|||Weeks||95% Confidence Interval|Median
2774998|NCT00706706|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2774999|NCT00706706|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.|||Weeks||95% Confidence Interval|Median
2775000|NCT00706654|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
2775001|NCT00706654|Secondary|Percentage of Responders up to Week 38|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
2775002|NCT00706654|Secondary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse||Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
2775152|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12||12 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
2775003|NCT00706654|Primary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26|A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline to Week 26|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
2775004|NCT00706641|Secondary|Increase in Cas3 Expression|Cas3 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
2775005|NCT00706641|Secondary|Reduced Ki-67 Expression|Ki-67 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
2775006|NCT00706641|Secondary|Post-Cystectomy Pathologic Stage|Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present|Staged Post-Cystectomy and dasatinib treatment||||percentage of particpants||95% Confidence Interval|Number
2775007|NCT00706641|Secondary|Pathologic Complete Response (pCR) Rate|Pathologic complete response (pCR) rate is defined as no residual evidence of muscle-invasive disease at cystectomy (< pT0).|24 months|23 participants completed treatment and underwent radical cystectomy.|||participants|||Number
2775008|NCT00706641|Secondary|Reduced pSFK Expression|pSFK levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
2775009|NCT00706641|Secondary|Grade 3/4 Toxicities|Report grade 3/4 toxicities during treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.|Time of consent through 30 days after treatment discontinuation|24 patients received treatment, 1 patient ineligible due to small cell histology after starting dasatinib treatment and was not evaluable.|||percentage of particpants|||Number
2775010|NCT00706641|Primary|Feasibility|Feasibility for this trial is defined as at least 60% (>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)|From enrollment to completion of radical cystectomy|All patients who completed dasatinib|||participants|||Number
2775011|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy|"Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment (C12,14 for BIBF1120 ; C24,7 and C24,14 for BIBW2992)~C12,14: plasma concentration at 12 hours Day 14"|Day7, Day 14|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2775012|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy|Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment|Day 15, Day 29 and Day 57|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2775013|NCT00706628|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set|||percentage of participants|||Number
2775014|NCT00706628|Secondary|Incidence and Worst Intensity of Adverse Events With Grading According CTCAE|Incidence and worst intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set|||percentage of participants|||Number
2775015|NCT00706628|Secondary|Overall Survival (Time to Death)|Overall survival (time to death) was calculated in days from baseline to the date of reporting of death. Time is expressed in Median number of days.|start of treatment until 28 days after end of treatment (Up to 52 weeks)|FAS|||days||95% Confidence Interval|Median
2775016|NCT00706628|Secondary|Time to Progression|"Time from first administration of study drug until disease progression according to composite endpoint.~Time is expressed in Median number of days."|start of treatment until end of the treatment (Up to 48 weeks)|FAS|||days||95% Confidence Interval|Median
2775017|NCT00706628|Secondary|Duration of RECIST Response|"Time from first observation of response (PR, CR, confirmed or unconfirmed) until progression according to RECIST (version 1.0) or death.~Duration is expressed in Median number of days."|Up to 48 weeks|FAS (RECIST evaluable set)|||days||Inter-Quartile Range|Median
2775018|NCT00706628|Secondary|Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks|Objective response is defined as a Complete or Partial response Complete response [CR] for Target lesions: Disappearance of all target lesions. Complete response [CR] for Non- target lesions: Disappearance of all non-target lesions and normalization of tumour marker level Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|12, 24, 36 and 48 weeks|FAS (RECIST evaluable set)|||percentage of participants|||Number
2775019|NCT00706628|Secondary|RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks|RECIST (version 1.0) tumour progression rate at 12, 24, 36, and 48 weeks was calculated based on the occurrence of new lesions, or an increase in the sum of the longest lesion diameters of at least 20%.|12, 24, 36, and 48 weeks|FAS (RECIST evaluable set); RECIST evaluable set, which consisted of patients who had RECIST measurable disease at baseline.|||percentage of participants|||Number
2775020|NCT00706628|Secondary|Time to PSA Progression|"Time to PSA progression through 48 weeks was calculated as the number of days from first administration of study drug to the first time that there was an increase of 50% from the PSA nadir, provided the absolute increase was at least 5 ng/mL.~Time is expressed in median number of days."|Start of treatment until end of treatment (Up to 48 weeks)|FAS|||days||95% Confidence Interval|Median
2775021|NCT00706628|Secondary|Duration of PSA Response|"Duration of PSA response was calculated from the time of first 50% decline in PSA (compared to baseline) until the time at which there was an increase of 50% from the PSA nadir, provided that the absolute increase was at least 5 ng/mL. The increase had to be confirmed by a second consecutive measurement that was at least 50% above the nadir. If the PSA never showed a 50% increase over the nadir value, then the patient was censored at the last PSA measurement.~Duration of PSA response expressed in median number of days."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS|||days||Inter-Quartile Range|Median
2775022|NCT00706628|Secondary|Number of Patients Showing Prostate Serum Antigen (PSA) Response|"PSA response was evaluated according to the PSAWG guidelines. All patients achieving a fall in PSA of ≥50% from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria for PSA response. The confirmatory value had to be at least 50% lower than the baseline value, but could be higher than the original drop in PSA (first PSA value).~However, the confirmatory value could not be 50% higher than the first PSA value. If it was ≥50% higher than the first PSA, another sample was taken to determine if response had been achieved."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS|||percentage of participants|||Number
2775023|NCT00706628|Secondary|Progression Free Rate at 24 and 48 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to RECIST version 1.0"|24 weeks and 48 weeks|"Full analysis set (FAS), which consisted of all patients who received at least~1 dose of study medication and for whom progression status could be determined at 12 weeks."|||percentage of participants||95% Confidence Interval|Number
2775024|NCT00706628|Primary|Progression Free Rate (PFR) at 12 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0"|12 weeks|Modified full analysis set(mFAS): Patients who received at least 1 dose of study medication and for whom progression status could be determined at 12 weeks,excluding patients who discontinued treatment before 12 weeks for reasons other than PD.|||percentage of participants||95% Confidence Interval|Number
2775025|NCT00706589|Primary|Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)|The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.|10 week|ITT (Intention-To-Treat)analysis|||units on a scale||Full Range|Mean
2775026|NCT00706589|Secondary|1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.||10 weeks|||||||
2775027|NCT00706563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
2775028|NCT00706563|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
2775029|NCT00706563|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.~Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever"|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
2775030|NCT00706563|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results|||subjects|||Number
2775031|NCT00706563|Primary|Serconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|At Day 21||||factor|||Number
2775032|NCT00706563|Primary|Number of Serconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|At Day 21||||subjects|||Number
2775033|NCT00706563|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|At Day 0 and 21||||subjects|||Number
2775037|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.|Baseline||||Titers||Full Range|Geometric Mean
2775038|NCT00706550|Primary|IgM Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine||||Micrograms/ml||Full Range|Geometric Mean
2775039|NCT00706550|Primary|Immunoglobulin M (IgM) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline||||Micrograms/ml||Full Range|Geometric Mean
2775040|NCT00706550|Primary|IgG Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine||||Micrograms/ml||Full Range|Geometric Mean
2775041|NCT00706550|Primary|Immunoglobulin G (IgG) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline||||Micrograms/ml||Full Range|Geometric Mean
2775042|NCT00706511|Secondary|IVGTT (Intravenous Tolerance Test) - Disposition Index (DI)|Disposition Index (DI) is the product of sensitivity index (SI) by the amount of insulin secreted in response to blood glucose levels. It is a marker of the risk of type 2 diabetes. Low DI reflects a high risk of diabetes. DI can vary from 0 to an undefined upper limit. The physiological range for the Disposition Index is 500 to 5,000. Higher values represent a better outcome.|After treatment (6 weeks)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||score on a scale||Standard Deviation|Mean
2775043|NCT00706511|Secondary|IVGTT (Intravenous Tolerance Test) - Acute Insulin Response|"Acute Insulin Response is calculated as the area under the insulin curve for the first 19 minutes after intravenous glucose injection. Area under the insulin curve is expressed in pmol x min/L."|After treatment (6 weeks)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||pmol x min/L||Standard Deviation|Mean
2775044|NCT00706511|Secondary|IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI)|Sensitivity Index (SI): a measure of how much insulin the body needs to metabolize a given amount of glucose. SI is calculated using a mathematical model describing the profiles of blood glucose and serum insulin after intravenous glucose injection. SI varies from 0 to an undefined upper limit but generally under 20. Higher values of SI represent a better outcome.|After treatment (6 weeks)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||score on a scale||Standard Deviation|Mean
2775045|NCT00706511|Primary|Polysomnography - Sleep Efficiency|Sleep efficiency: a measure of objective sleep quality; calculated from the polygraphic sleep recording as the ratio of time spent asleep during the scheduled sleep period to total scheduled sleep period. Expressed in %. Varies from 0% (the subject did not sleep at all) to 100% (the subject spent the entire scheduled sleep period asleep).|After 6 weeks of CPAP (Treatment)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||score on a scale||Standard Deviation|Mean
2775046|NCT00706511|Primary|Polysomnography - Minutes of REM Stage||After 6 weeks of CPAP (Treatment)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||minutes||Standard Deviation|Mean
2775047|NCT00706511|Primary|Polysomnography - Minutes of N3 Stage|"Stage N3, sometimes referred to as delta sleep or slow wave sleep, is characterized by slow waves in the electro-encephalogram (EEG) that reflect synchronization of firing of cortical neurons. N3 sleep is considered the most restorative stage of sleep for both the brain and the rest of the body."|After 6 weeks of CPAP (Treatment)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||minutes||Standard Deviation|Mean
2775048|NCT00706511|Primary|Polysomnography - Apnea-hypopnea Index (AHI)|apnea-hypopnea index: number of apneas and hypopneas per hour of recording; a measure of the severity of obstructive sleep apnea; varies from min=0 to max=120; AHI between 0 and <5: no significant sleep apnea; AHI between 5 and <15: mild sleep apnea; AHI between 15 and <30: moderate sleep apnea; AHI of 30 and above: severe sleep apnea.|After 6 weeks of CPAP (Treatment)|One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart)|||units on a scale||Standard Deviation|Mean
2775049|NCT00706485|Secondary|Marginal Failure.|Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.|up to 10 years|Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.||||||
2775050|NCT00706485|Secondary|Number of Participants With Local Control|Local failure is defined as: extension of the tumor margin[s] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.|at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10||||participants|||Number
2775051|NCT00706485|Primary|Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use||At time of procedure||||participants|||Number
2775052|NCT00706446|Secondary|Asthma-related Quality of Life||1 year|Data was not collected for secondary outcomes due to study termination.||||||
2775053|NCT00706446|Secondary|Symptom-free Days||1 year|Data was not collected for secondary outcomes due to study termination.||||||
2775057|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Visit 10 (6 Weeks after Final PDT)|ITT observed|||particpants|||Number
2775058|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
2775059|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 7 (Week 9)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Visit 7 (Week 9)|ITT observed|||participants|||Number
2775060|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 5 (Week 6)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Visit 5 (Week 6)|ITT observed|||participant|||Number
2775061|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 3 (Week 3)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Visit 3 (Week 3)|ITT observed|||participants|||Number
2775062|NCT00706433|Secondary|Oozing/Vesiculation/Crusting 48 Hours After PDT #1|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|48 hours after PDT #1|ITT observed|||participants|||Number
2775063|NCT00706433|Secondary|Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 10 (6 Weeks after Final PDT)|ITT observed|||participants|||Number
2775064|NCT00706433|Secondary|Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
2775065|NCT00706433|Secondary|Scaling and Dryness at Visit 7 (Week 9)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 7 (Week 9)|ITT observed|||participants|||Number
2775066|NCT00706433|Secondary|Scaling and Dryness at Visit 5 (Week 6)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 5 (Week 6)|ITT observed|||participants|||Number
2775067|NCT00706433|Secondary|Scaling and Dryness at Visit 3 (Week 3)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 3 (Week 3)|ITT observed|||participants|||Number
2775068|NCT00706433|Secondary|Scaling and Dryness 48 Hours After PDT #1|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|48 hours after PDT #1|ITT observed|||participants|||Number
2775069|NCT00706433|Secondary|Stinging/Burning at Visit 10 (6 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 10 (6 Weeks after Final PDT)|ITT observed|||participants|||Number
2775070|NCT00706433|Secondary|Stinging/Burning at Visit 9 (3 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
2775071|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 7 (Week 9 - post light treatment)|ITT observed|||participants|||Number
2775072|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 7 (Week 9 - during light treatment)|ITT observed|||participants|||Number
2775073|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 7 (Week 9 - prior to light treatment)|ITT observed|||participants|||Number
2775074|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 7 (Week 9 - before study drug application)|ITT observed|||participants|||Number
2775075|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 5 (Week 6 - post light treatment)|ITT observed|||participants|||Number
2775076|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 5 (Week 6 - during light treatment)|ITT observed|||participants|||Number
2775077|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 5 (Week 6 - prior to light treatment)|ITT observed|||participants|||Number
2775078|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 5 (Week 6 - before study drug application)|ITT observed|||participants|||Number
2775079|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 3 (Week 3 - post light treatment)|ITT observed|||participants|||Number
2775080|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 3 (Week 3 - during light treatment)|ITT observed|||participants|||Number
2775081|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 3 (Week 3 - before light treatment)|ITT observed|||participants|||Number
2775082|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Visit 3 (Week 3 - before study drug application)|ITT observed|||participants|||Number
2775083|NCT00706433|Secondary|Stinging/Burning 48 Hours Post PDT #1|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|48 hours post PDT #1|ITT observed|||participants|||Number
2775084|NCT00706433|Secondary|Stinging/Burning at Baseline - Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline - post light treatment|ITT observed|||participants|||Number
2775085|NCT00706433|Secondary|Stinging/Burning at Baseline - During Light|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline - during light|ITT observed|||participants|||Number
2775086|NCT00706433|Secondary|Stinging/Burning at Baseline - Before Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline - before light treatment|ITT observed|||participants|||Number
2775153|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6||6 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
2775087|NCT00706433|Secondary|Edema 6 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|6 weeks after final PDT|ITT observed|||participants|||Number
2775088|NCT00706433|Secondary|Edema 3 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|3 weeks after final PDT|ITT observed|||participants|||Number
2775089|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - post light treatment)|ITT observed|||participants|||Number
2775090|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Prior to Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - prior to light treatment)|ITT observed|||participants|||Number
2775091|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - before study drug application)|ITT observed|||participants|||Number
2775092|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - post light treatment)|ITT observed|||participants|||Number
2775093|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Pre Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - pre light treatment)|ITT observed|||participants|||Number
2775094|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - before study drug application)|ITT observed|||participants|||Number
2775095|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - post light treatment)|ITT observed|||participants|||Number
2775096|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before light treatment)|ITT observed|||participants|||Number
2775097|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before study drug application)|ITT observed|||participants|||Number
2775098|NCT00706433|Secondary|Edema 48 Hours After PDT #1|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|48 hours after PDT #1|ITT observed|||participants|||Number
2775099|NCT00706433|Secondary|Edema at Baseline - Post Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - Post Light Treatment|ITT observed|||participants|||Number
2775100|NCT00706433|Secondary|Edema at Baseline - Pre Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - pre light treatment|ITT observed|||participants|||Number
2775101|NCT00706433|Secondary|Erythema 6 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|6 Weeks after Final PDT|ITT observed|||participants|||Number
2775102|NCT00706433|Secondary|Erythema 3 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|3 Weeks after Final PDT|ITT observed|||participants|||Number
2775103|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - post light treatment)|ITT, observed|||participant|||Number
2775104|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Pre Light Treatment)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - pre light treatment)|ITT observed|||participants|||Number
2775105|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - prior to study drug application)|ITT observed|||participants|||Number
2775106|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - post light treatment)|ITT, observed|||participants|||Number
2775107|NCT00706433|Secondary|Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Weeks 6 - pre-light treatment)|ITT, observed|||participants|||Number
2775108|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - prior to study drug application)|ITT, observed|||participants|||Number
2775109|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - post light treatment)|ITT, observed|||participants|||Number
2775110|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre-light)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre-light)|ITT, observed|||participants|||Number
2775111|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre Study Drug Application)|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre study drug application)|ITT, observed|||participants|||Number
2775154|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2||2 weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
2775112|NCT00706433|Secondary|Erythema 48 Hours After PDT #1|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|48 hours after PDT #1|ITT, observed|||participants|||Number
2775113|NCT00706433|Secondary|Erythema at Baseline - Post Light Treatment|Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline - post light treatment|ITT observed|||participants|||Number
2775114|NCT00706433|Secondary|Erythema at Baseline (Pre-light)|"After solution application, prior to light treatment~﻿ Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema"|Baseline (pre-light)|ITT, observed|||participants|||Number
2775115|NCT00706433|Secondary|Hypopigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed|||participants|||Number
2775116|NCT00706433|Secondary|Hypopigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed|||participants|||Number
2775117|NCT00706433|Secondary|Hypopigmentation at Visit 7 (Week 9)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed|||participants|||Number
2775118|NCT00706433|Secondary|Hypopigmentation at Visit 5 (Week 6)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed|||participants|||Number
2775119|NCT00706433|Secondary|Hypopigmentation at Visit 3 (Week 3)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed|||participants|||Number
2775120|NCT00706433|Secondary|Hypopigmentation 48 Hours Post PDT #1|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|48 hours post PDT #1|ITT, observed|||participants|||Number
2775121|NCT00706433|Secondary|Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed|||participants|||Number
2775122|NCT00706433|Secondary|Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed|||participants|||Number
2775123|NCT00706433|Secondary|Hyperpigmentation at Visit 7 (Week 9)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed|||participant|||Number
2775155|NCT00706329|Primary|Close Belly Button or Umbilical Hernia|The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.|After surgery, subjects will be followed at intervals of one month and six months from date of surgery.|||||||
2775124|NCT00706433|Secondary|Hyperpigmentation at Visit 5 (Week 6)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed|||participants|||Number
2775125|NCT00706433|Secondary|Hyperpigmentation at Visit 3 (Week 3)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed|||participants|||Number
2775126|NCT00706433|Secondary|Hyperpigmentation 48 Hours After PDT #1|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|48 hours after PDT #1|ITT, observed|||participants|||Number
2775127|NCT00706433|Secondary|Investigator Global Assessment of Acne Severity Successes|"Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.~﻿0 Clear skin with no inflam or non-inflam lesions~Almost clear; rare non-inflam lesions with no more than a few small inflam lesions~Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)~Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule~Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules"|Baesline and 6 weeks after final treatment|ITT LOCF|||participants|||Number
2775128|NCT00706433|Secondary|Change in Inflammatory Lesion Counts Relative to Baseline|change in lesion counts compared to baseline|Baseline and 6 weeks after final treatment|ITT LOCF|||change in lesion count||Standard Deviation|Median
2775129|NCT00706433|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|6 weeks after final treatment|ITT, observed|||participants|||Number
2775130|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 6 weeks after final treatment|ITT LOCF|||percent change in lesion count||Standard Deviation|Median
2775131|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT LOCF|||percent change in lesion count||Standard Deviation|Median
2775132|NCT00706433|Primary|Investigator Global Assessment of Acne Severity Successes|Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.|Baseline and 3 weeks after final treatment|ITT LOCF|||participants|||Number
2775133|NCT00706433|Primary|Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT analysis, LOCF|||change in lesion count||Standard Deviation|Median
2775134|NCT00706407|Primary|Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis|The correlation of the NIRS pattern itself (independent of Qmax and PVR) to BOO. We looked at if the use of the NIRS is a comparable predictor for BOO in patients who were obstructed and those who weren't. The goal of the NIRS is to provide a non-invasive means to diagnose BOO. According to the NIRS algorithm, a downward NIRS pattern related to a higher probability of obstruction and and upward pattern relates to a higher probability of non obstruction.|Assessed at 3 and 6 months, post operatively||||participants|||Number
2775135|NCT00706355|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression up to C2 D1|Efficacy analysis set included all enrolled participants who received the study treatment and had measurable disease at baseline.|||Percentage of participants||95% Confidence Interval|Number
2775136|NCT00706355|Secondary|Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3'-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2|F-fluoro-3'-deoxy-3'-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN).|Cycle 2 Day 1|Data was not analyzed due to insufficient number of participants enrolled.|||Standardized Uptake Value (SUV)||Standard Deviation|Mean
2775137|NCT00706355|Secondary|Apparent Oral Clearance (CL/F) for PF-04217903|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Liter/hr (L/hr)||Standard Deviation|Geometric Mean
2775156|NCT00706238|Secondary|Immunogenicity at Defined Time Points.||At 13 defined time points.|As the study was terminated before the end of recruitment, data was not collected.||||||
2775138|NCT00706355|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Ratio||Standard Deviation|Mean
2775139|NCT00706355|Secondary|Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Ratio||Standard Deviation|Mean
2775140|NCT00706355|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng*hr/mL||Standard Deviation|Geometric Mean
2775141|NCT00706355|Secondary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng*hr/mL||Standard Deviation|Geometric Mean
2775142|NCT00706355|Secondary|Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2775143|NCT00706355|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||hr||Full Range|Median
2775144|NCT00706355|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng/mL||Standard Deviation|Geometric Mean
2775145|NCT00706355|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1|The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2775146|NCT00706355|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events.|Baseline up to 21 days after the start of each increased treatment dose|DLT analysis set: participants who received first cycle of study medication and did not temporarily or permanently discontinue from study medication or missed more than 3 consecutive days of PF-04217903 dosing for reasons other than DLTs within first cycle.|||Participants|||Number
2775147|NCT00706355|Primary|Recommended Phase 2 Dose (RP2D)||Baseline up to 21 days after the start of each increased treatment dose|Data was not analyzed due to insufficient number of participants enrolled.|||mg|||Number
2775148|NCT00706355|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.|Baseline up to 21 days after the start of each increased treatment dose|Analysis population included all enrolled participants who received at least 1 dose of the study treatment.|||mg|||Number
2775149|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24||24 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
2775164|NCT00706238|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study, up to 2.5 years per patient|The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.|||Participants|||Count of Participants
2775165|NCT00706238|Primary|Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)|The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.|During the entire study, up to 2.5 years per patient|The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.|||Participants|||Count of Participants
2775166|NCT00706134|Secondary|Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.|Baseline to end of study (week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mmHg||Standard Error|Least Squares Mean
2775167|NCT00706134|Secondary|Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||Ratio||Standard Error|Least Squares Mean
2775168|NCT00706134|Secondary|Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mmHg||Standard Error|Mean
2775169|NCT00706134|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Response|Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.|Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||Percentage of participants|||Number
2775170|NCT00706134|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
2775171|NCT00706134|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
2775172|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||ercentage of participants in subgroup|||Number
2775173|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||ercentage of participants in subgroup|||Number
2775174|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||ercentage of participants in subgroup|||Number
2775175|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||percentage of participants|||Number
2775176|NCT00706121|Secondary|Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||Participants|||Count of Participants
2775177|NCT00706121|Primary|Effect of Selenium on Occurrences of Multiple (>2) Adenomas||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
2775178|NCT00706121|Primary|Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence||From 1 year post randomization through study completion||||Participants|||Count of Participants
2775179|NCT00706121|Primary|Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo|Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia|From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
2775180|NCT00706121|Primary|Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
2775181|NCT00706095|Primary|Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|throughout the study and up to 30 days after the last dose of study drug|ITT Population|||Number of Participants|||Number
2775182|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
2775183|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population|||ng*hr/mL||Standard Deviation|Mean
2775184|NCT00706030|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) of Neratinib in combination with vinorelbine in subjects with advanced solid tumors.|From Day 1 to Day 21.|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||mg|||Number
2775185|NCT00706030|Secondary|Duration Of Response|Duration of response for subjects who had complete or partial response from first response to disease progression, death or last assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first PD/death, up to four years and six months.|Subjects in evaluable population who had CR or PR according to Independent Assessment.|||weeks||Full Range|Median
2775186|NCT00706030|Secondary|Progression-Free Survival|Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.|From first dose date to progression or death, up to four years and six months.|Evaluable population, independent assessment.|||weeks||95% Confidence Interval|Median
2775187|NCT00706030|Secondary|Clinical Benefit Rate|Percentage of participants with partial response (PR) or complete response (CR) or stable disease > 24 weeks by independent assessment for subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to four years and six months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2775188|NCT00706030|Primary|Overall Response Rate|Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to four years and six months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2775189|NCT00706004|Secondary|Serum Albumin||baseline and 4 weeks|Participants who completed the study|||g/dL||Standard Deviation|Mean
2775190|NCT00706004|Secondary|Serum Prealbumin||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775191|NCT00706004|Secondary|Serum Vitamin E||baseline and 4 weeks|Participants who completed the study|||mg/L||Standard Deviation|Mean
2775192|NCT00706004|Secondary|Serum Vitamin A||baseline and 4 weeks|Participants who completed the study|||ug/dL||Standard Deviation|Mean
2775193|NCT00706004|Secondary|Serum Vitamin D||baseline and 4 weeks|Participants who completed the study|||ng/mL||Standard Deviation|Mean
2775194|NCT00706004|Secondary|Serum Glucose||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775195|NCT00706004|Secondary|Serum Phosphate||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775196|NCT00706004|Secondary|Serum Magnesium||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775197|NCT00706004|Secondary|Serum Calcium||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775198|NCT00706004|Secondary|ALT||baseline and 4 weeks|Participants who completed the study|||U/L||Standard Deviation|Mean
2775199|NCT00706004|Secondary|AST||baseline and 4 weeks|Participants who completed the study|||U/L||Standard Deviation|Mean
2775200|NCT00706004|Secondary|Serum Creatinine||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775201|NCT00706004|Secondary|Serum BUN||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
2775202|NCT00706004|Secondary|Serum Bicarb||baseline and 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
2775203|NCT00706004|Secondary|Serum Potassium||baseline and 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
2775204|NCT00706004|Secondary|Serum Chloride||baseline and 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
2775205|NCT00706004|Secondary|Serum Sodium||baseline, 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
2775309|NCT00705367|Primary|Short-term Period: MeanSystolic and Diastolic Blood Pressure|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||mm Hg||Standard Deviation|Mean
2775206|NCT00706004|Secondary|Self Reported Adverse Effects at Each Study Visit|Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.|During entire study period|Participants who completed the study|||participants|||Number
2775207|NCT00706004|Secondary|Body Mass Index||baseline, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||kg/m^2||Standard Deviation|Mean
2775208|NCT00706004|Secondary|Bristol Stool Scale Score|The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||scores on a scale||Standard Deviation|Mean
2775209|NCT00706004|Secondary|Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||scores on a scale||Standard Deviation|Mean
2775210|NCT00706004|Primary|Number of Spontaneous Bowel Movements Per Week||2-week run-in period, 2-weeks of treatment, 4-weeks of treatment|Participants who completed the study|||bowel movements||Standard Deviation|Mean
2775211|NCT00705939|Secondary|Platelet Count||Platelet count at Baseline and Months 12, 24 and 36||||Platelets per cubic millimeter||Standard Deviation|Mean
2775212|NCT00705939|Secondary|Hemoglobin||Hemoglobin at Baseline and Months 12, 24 and 36||||mg/dL||Standard Deviation|Mean
2775213|NCT00705939|Other Pre-specified|Liver Volume Multiples of Normal (MN)|Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).|Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI.|||Multiples of Normal Liver Volume||Standard Deviation|Mean
2775214|NCT00705939|Other Pre-specified|Spleen Volume Multiples of Normal (MN)|Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)|Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.|||Multiples of Normal Spleen Volume||Standard Deviation|Mean
2775215|NCT00705939|Secondary|Liver Volume|Liver volume measured by MRI|Liver volume at Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI .|||mL||Standard Deviation|Mean
2775216|NCT00705939|Primary|Spleen Volume|Spleen volume measured by MRI|Spleen Volume at Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.|||mL||Standard Deviation|Mean
2775217|NCT00705874|Secondary|Pharmacokinetics||End of Study|||||||
2775218|NCT00705874|Secondary|Drug Safety||Ongoing|||||||
2775219|NCT00705874|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).~DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:~Any nonhematologic toxicity > Grade 3 lasting > 3 days~Grade 4 thrombocytopenia~Grade 4 Anemia on the next scheduled dosing day~Grade 4 Neutropenia (lasting > than 5 days~Any febrile neutropenia (Grade 3 or 4))~Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity"|End of Study|Cohorts comprised 3 patients. When a patient experienced a treatment related toxicity qualifying as a DLT, up to 3 additional patients were to be enrolled at that dose. Patients who completed cycle 1 per protocol were evaluable.|||mg|||Number
2775220|NCT00705783|Secondary|Time to Discontinuation|Time to discontinuation was defined as the date of randomization to the date of study discontinuation.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
2775221|NCT00705783|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient's condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Deviation|Mean
2775222|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Negative Subscale Score|The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
2775352|NCT00704938|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module.|5 months||||Participants|||Number
2775223|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Positive Subscale Score|The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
2775224|NCT00705783|Secondary|Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score|"The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement."|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Mean
2775225|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Total Score|The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
2775226|NCT00705783|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.|||Percentage of patients|||Number
2775227|NCT00705783|Secondary|Percentage of Responders|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.|||Percentage of patients|||Number
2775228|NCT00705783|Secondary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria|This is the key secondary Outcome Measure.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
2775229|NCT00705783|Primary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse|A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
2775230|NCT00705757|Primary|The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.|"Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.~Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement."|one year|Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.|||L*a*b*||Standard Error|Mean
2775231|NCT00705718|Secondary|Secondary Endpoint - Effectiveness Evaluation|"The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.~Stent Graft migration through 12 months~Stent Graft Patency through 12 months~All stent Graft Endoleaks at 1-month, 6-months, and 12-month~Secondary Procedures to correct Type I and type III Endoleaks through 12 months~Secondary Endovascular Procedures through 12 months~Technical Observations through 12 months"|12 months|Number of subjects enrolled in the study arm|||percentage of evaluable subjects|||Number
2775232|NCT00705718|Primary|Primary Effectiveness Endpoint (Treatment Success)|"Treatment success is defined as Technical success and the following:~Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month~Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months~Freedom from aneurysm rupture through 12 months~Freedom from conversion to surgery through 12 months~Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months~Freedom from stent graft occlusion at 12 months"|12 months|The number of evaluable subjects for ths endpoint.|||participants|||Number
2775233|NCT00705718|Primary|Primary Effectiveness Endpoint (Technical Success)|Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.|Intra-operatively|The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.|||participants|||Number
2775234|NCT00705718|Secondary|Secondary Endpoints - Safety Evaluation|"The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.~Aneurysm-Related Mortality through 12 months~All-Cause Mortality with 30 days~All-Cause Mortality within 12 months~Major Adverse Events through 12 months~Adverse Events through 12 months~Unanticipated Adverse Device Events~Serious Adverse Events (SAEs) As reported at the time of the data cut off.~Device Related Adverse Events~Procedure Related Adverse Events~Adverse Events (excluding SAEs)"|12 months|Number of subjects enrolled in the study arm|||percentage of evaluable participants|||Number
2775235|NCT00705718|Primary|Major Adverse Events Within 30 Days of Index Procedure|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days||||percentage of participants|||Number
2775236|NCT00705718|Primary|Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days (Safety)|Freedom from Major Adverse Events within 30 Days of Implant|||percentage of participants|||Number
2775237|NCT00705679|Primary|Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events|This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.|Throughout study, up to 2.5 years|All participants randomized (intention-to-treat).|||participants|||Number
2775238|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
2775239|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
2775240|NCT00705679|Primary|Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
2775241|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
2777447|NCT00688753|Secondary|Disease Control Rate (SD + PR + CR)|DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR|6 mos|PP,ITT|||% Participants||90% Confidence Interval|Number
2775242|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
2775243|NCT00705679|Primary|Person-years of Follow-up of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
2775244|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
2775245|NCT00705679|Secondary|Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product|The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.|Throughout study, up to 2.5 years|Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure.|||participants|||Number
2775246|NCT00705679|Primary|Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
2775247|NCT00705679|Primary|Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
2775248|NCT00705666|Primary|The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).||Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.|For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).|||Participants|||Number
2775249|NCT00705653|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT).~Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047."|The MTD had to occur during cycle 1 of treatment||||mg|||Number
2775250|NCT00705653|Secondary|Preliminary Efficacy|As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.|Patients with non-missing overall response|||percentage (of participants)|||Number
2775251|NCT00705614|Secondary|Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months|The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Surgical Procedures|||Number
2775252|NCT00705614|Secondary|Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Days||Standard Deviation|Mean
2775253|NCT00705614|Secondary|Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Hospital Stays||Standard Deviation|Mean
2775254|NCT00705614|Secondary|Number of Participants With a Draining Fistula By Study Visit|The number of participants with a draining fistula was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775255|NCT00705614|Secondary|Work/Daily Activity Status Score By Study Visit|The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.|Up to 5 Years|The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
2775256|NCT00705614|Secondary|The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit|The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.|Up to 5 Years|The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
2775257|NCT00705614|Secondary|Participant Assessment of Overall Health Status By Study Visit|The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.|Up to 5 Years|The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
2775258|NCT00705614|Primary|Number of Participants With Lymphoproliferative Disorders/Malignancies|The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775259|NCT00705614|Primary|Number of Participants With Hematologic Conditions|The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775260|NCT00705614|Primary|Number of Participants With Demyelinating Neurological Disorders|The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775261|NCT00705614|Primary|Number of Participants With New or Worsening Congestive Heart Failure|The number of participants with new or worsening congestive heart failure was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775262|NCT00705614|Primary|Number of Participant Fatalities|The number of participant fatalities was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775263|NCT00705614|Primary|Number of Participants With Infusion-Related Reactions/Hypersensitivity|The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775264|NCT00705614|Primary|Number of Participants With Serious Infections|The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
2775265|NCT00705575|Secondary|Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.|||Percentage|||Number
2775266|NCT00705575|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
2775267|NCT00705575|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 8|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
2775268|NCT00705575|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to end of study (Week 12)|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
2775269|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])|The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[360]) data.|||Grams per kilogram||Standard Deviation|Mean
2775270|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])|The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose up to 240 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[240]) data.|||Grams per kilogram||Standard Deviation|Mean
2775271|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 180 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[180]) data.|||Grams per kilogram||Standard Deviation|Mean
2775272|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])|The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period.|Predose and up to 120 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-120]) data.|||Grams per kilogram||Standard Deviation|Mean
2775273|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period.|Predose and up to 60 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-60]) data.|||Grams per kilogram||Standard Deviation|Mean
2775274|NCT00705536|Secondary|Maximum Glucose Infusion Rate (GIR[Max])|Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable GIR(max) data.|||Milligrams per kilogram per minute||Standard Deviation|Mean
2775275|NCT00705536|Primary|Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)|"Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]).~Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog + rHuPH20 or Humulin-R + rHuPH20 with evaluable relative bioavailability (AUC[insulin+rHuPH20]/AUC[insulin alone]) data.|||Ratio of AUC(ins+rHuPH20)/AUC(ins alone)||Standard Deviation|Mean
2775276|NCT00705536|Primary|Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])|Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-tmaxPH20) data.|||Picomoles per liter times minutes||Standard Deviation|Mean
2775277|NCT00705536|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])|Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-t') data.|||Picomoles per liter times minutes||Standard Deviation|Mean
2775278|NCT00705536|Secondary|Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])|"Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.~Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, or Humulin-R + rHuPH20 with evaluable tGIR(late50%) data.|||Minutes||Standard Deviation|Mean
2775279|NCT00705536|Secondary|Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])|Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(early50%) data.|||Minutes||Standard Deviation|Mean
2775280|NCT00705536|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(max) data.|||Minutes||Standard Deviation|Mean
2775281|NCT00705536|Primary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable Cmax data.|||Picomoles per liter||Standard Deviation|Mean
2775282|NCT00705536|Primary|Time to Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tmax data.|||Minutes||Standard Deviation|Mean
2775283|NCT00705523|Secondary|Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.|The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.|12 weeks of treatment, with a follow-up one month after treatment||||alcohol composite score||Standard Deviation|Mean
2775284|NCT00705523|Primary|Rate of Heavy Drinking Days Per Week.|Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).|12 weeks of treatment and one month follow-up||||rate of heavy drinking days per week||Standard Deviation|Median
2775285|NCT00705484|Primary|Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories|The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities.|Up to 5 years.|All enrolled participants. The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade.|||Percentage of participants|||Number
2775286|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR|"Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 4, 8, 12, 16, 20|Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.|||Participants|||Number
2775353|NCT00704938|Primary|Clinical Response (Complete Response + Partial Response)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.|5 months||||Participants|||Number
2775287|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)|"Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 2, 4, 8, 12, 16, or 20|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Participants|||Number
2775288|NCT00705432|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL."|At FW 12 and at 72 weeks after randomization|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Participants|||Number
2775289|NCT00705432|Secondary|Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR."|At FW 24|Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.|||Percentage of participants|||Number
2775290|NCT00705432|Primary|Sustained Virologic Response (SVR) Rate|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR."|At Follow-up Week (FW) 24|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Percentage of participants|||Number
2775291|NCT00705406|Other Pre-specified|Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).|||Fold Change from Baseline||Standard Error|Mean
2775292|NCT00705406|Other Pre-specified|Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir.|||nM||Standard Error|Mean
2775293|NCT00705406|Other Pre-specified|Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).|||Fold Change from Baseline||Standard Error|Mean
2775294|NCT00705406|Other Pre-specified|Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.|Baseline|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group.|||nM||Standard Error|Mean
2775295|NCT00705406|Other Pre-specified|Incidence of Influenza-related Complications|Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.|14 days|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||participants|||Number
2775354|NCT00704912|Secondary|Prevalence of Metabolic Syndrome||Baseline, 4 months||||participants|||Number
2775296|NCT00705406|Other Pre-specified|Time to Resolution of Fever|Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||hours||95% Confidence Interval|Median
2775297|NCT00705406|Other Pre-specified|Subject's Severity of Illness (Score*Hours)|"A subject's severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.~The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21."|Information collected predose on Day 1 and then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||score*hours||Full Range|Median
2775298|NCT00705406|Secondary|Change in Influenza Virus Shedding|Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).|Baseline and Days 3, 4, 9|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||log10(TCID50/mL)||95% Confidence Interval|Median
2775299|NCT00705406|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR.|||hours||95% Confidence Interval|Median
2775300|NCT00705367|Secondary|Long-term Period: Number of Participants With Abatacept-specific Antibodies|Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.|Day15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of abatacept and had an immunogenicity test result.|||Participants|||Number
2775301|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if <LLN preRX, >1.05*preRX if >ULN preRX; >ULN if <LLN preRX, <LLN if >ULN preRX; potassium: chloride: calcium: phosphorous:|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
2775302|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
2775303|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX<LLN, use <0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN, >1.25*ULN, <0.8*preRX if preRX <LLN or >1.2*preRX if preRX >ULN; >ULN if preRX <LLN, <LLN if >ULN preRX; neutrophils+bands (*10^3 c/uL): if value <1.00*10^3 c/uL; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL; monocytes (*10^3 c/uL): if value >2000/mm^3; basophils (*10^3 c/uL): if value >400/mm^3; eosinophils (*10^3 c/uL): if value> 0.750*10^3 c/uL|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
2775304|NCT00705367|Primary|Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities|Laboratory tests consisted of complete blood count, chemistry, and urinalysis.|Screening and Days 1 and 2|All participants who received at least 1 dose of study drug|||Participants|||Number
2775305|NCT00705367|Primary|Short-term Period: Mean Temperature|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||Degrees Celsius||Standard Deviation|Mean
2775306|NCT00705367|Secondary|Maximum (Cmax) Plasma Concentration of Abatacept|Cmax is a drug's maximum, or peak, concentration observed after its administration.|Postdosing Day 1|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2775310|NCT00705367|Primary|Short-term Period: Number of Adverse Events (AEs) Related to Study Drug|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.|||Events|||Number
2775311|NCT00705367|Secondary|Minimum (Cmin) Plasma Concentration of Abatacept|Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.|Days 15, 29, 85, 169, 253 and 337|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.|||ug/mL||Standard Deviation|Mean
2775312|NCT00705367|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.|||Participants|||Number
2775313|NCT00705367|Primary|Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
2775314|NCT00705341|Secondary|Predictive Value of Methacholine Challenge Test for Phase 1|Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls|one time||||% predictive value||95% Confidence Interval|Number
2775315|NCT00705341|Primary|Methacholine Challenge Test Result for Phase 2|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks|weeks 0, 4|There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over.|||mg/ml||Full Range|Geometric Mean
2775316|NCT00705289|Primary|Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.|At Baseline|All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.|||Score on a scale||Standard Deviation|Mean
2775317|NCT00705289|Primary|Baseline Raw DAS28 by Country of Residence|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.|At Baseline||||Score on a scale||Standard Deviation|Mean
2775318|NCT00705289|Primary|Baseline Raw DAS28 by Gender|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.|||Score on a scale||Standard Deviation|Mean
2775319|NCT00705289|Primary|Baseline Raw DAS28 by Time Since Diagnosis|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.|At Baseline||||Score on a scale||Standard Deviation|Mean
2775320|NCT00705289|Primary|Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.|||Score on a scale||Standard Deviation|Mean
2775321|NCT00705263|Primary|Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.|Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.|After 4 weeks of treatment.|Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol|||Satisfied Participants|||Number
2775355|NCT00704912|Secondary|Change in Weight|Change from baseline to end of the 4-month intervention.|Baseline, 4 months||||kg||95% Confidence Interval|Least Squares Mean
2775356|NCT00704912|Secondary|Ovulation Rate||Up to 4 months||||total number of ovulations|Clomiphene Treatment Cycles||Number
2775322|NCT00705250|Primary|Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.|The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|up to 3 years||||percentage of evaluable participants|||Number
2775323|NCT00705224|Secondary|Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline|Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study.|Week 12 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 210 participants demonstrated early virological response (N=158 and N=50). 2 participants of the 210 had missing values.|||Percentage of Participants|||Number
2775324|NCT00705224|Secondary|Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively).|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 29 participants demonstrated virological relapse (N=18 and N=11) and were therefore included in this analysis.|||Percentage of Participants|||Number
2775325|NCT00705224|Secondary|Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline|Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration.|Week 24 or 48 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 208 achieved RFT (N=156 and N=51) and were therefore included in this analysis. 1 participant of the 208 had missing values.|||Percentage of Participants|||Number
2775326|NCT00705224|Secondary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 181 achieved SVR (N=140 and N=40) and were therefore included in this analysis. 1 participant of the 181 had missing values.|||Percentage of Participants|||Number
2775327|NCT00705224|Primary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study|Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study.|||Percentage of Participants||95% Confidence Interval|Number
2775328|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3|Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 7|Study eye ITT population, subjects with non-missing data|||Score on a scale||Standard Deviation|Mean
2775329|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2|Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 3|Study eye, ITT population, non-missing data|||Score on a scale||Standard Deviation|Mean
2775330|NCT00705159|Primary|Change From Baseline in the Total Blepharoconjunctivitis Grade.|Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to 15 days|Study eye, ITT Population, Non-missing data|||Score on a scale||Standard Deviation|Mean
2775331|NCT00705146|Secondary|Pain|AUSCAN 3.1 pain subscale. Possible score range is 0 to 50. Lower scores indicate less pain. Change scores are reported (baseline to 4 weeks splint wear) for each of the two splints.|4 weeks|Pooled all participants for the phase they wore the hybrid, then comfort cool splints, respectively. Mean change scores are reported|||units on a scale||95% Confidence Interval|Mean
2775332|NCT00705146|Primary|Hand Function|Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.|4 weeks|Pooled participants from both arms from the phase they wore the hybrid splint, then from the phase they wore the comfort cool splint. Mean change scores are reported.|||units on a scale||95% Confidence Interval|Mean
2775333|NCT00705107|Secondary|Average Length of Treatment.||Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.||||weeks||Standard Deviation|Mean
2775334|NCT00705107|Primary|Number of Subjects Who Completed Treatment.||Assessed at the end of the 48-week treatment.|All participants|||Participants|||Number
2775335|NCT00705081|Primary|Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy|Achievement of LDL-C target levels as determined by physician|4-6 weeks after the first visit|All patients enrolled|||Participants|||Number
2775336|NCT00705081|Primary|Intensity of Adverse Events Reported|Intensity of adverse events reported after co-administration therapy|4-6 weeks after the first visit|All participants enrolled|||Participants|||Number
2775337|NCT00705081|Primary|Number of Participants Reporting Adverse Events|Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)|4-6 weeks after the first visit|All participants enrolled|||Participants|||Number
2775338|NCT00705016|Secondary|Safety - Number of Participants Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab.|||participants|||Number
2775339|NCT00705016|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2775340|NCT00705016|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2775341|NCT00705016|Secondary|Disease Control Rate|The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
2775342|NCT00705016|Secondary|Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
2775343|NCT00705016|Secondary|Overall Survival (OS) Time|The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2775344|NCT00705016|Primary|Progression-free Survival (PFS) Time: Investigator Read|The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2775357|NCT00704912|Primary|Live Birth Rate||Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.||||participants|||Number
2775358|NCT00704847|Secondary|Questionnaire to Assess Pain|"Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled No Pain and 100 equaled Worst Pain Imaginable. Patients were instructed not to take analgesics for 3 days prior to the VAS."|Baseline, month 1, month 6, month 12, month 24|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.|||percentage of change||Standard Deviation|Mean
2775345|NCT00705003|Secondary|The Change From Baseline on the HAM-A at Week 6|"The 14-item HAM-A scale rates the patient's level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer's assessment of the patient's appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960).~The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement."|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
2775346|NCT00705003|Secondary|The Change From Baseline in the Quick Inventory of Depressive Symptomatology - 16 Item Self-Report (QIDS-SR16) at Week 6|"The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, & psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter:~highest score from items 1-4 (Sleep Items)~item 5 score~highest score from items 6-9 (appetite/weight)~item 10 score~item 11 score~item 12 score~item 13 score~item 14 score~highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale & total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement"|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
2775347|NCT00705003|Secondary|The Change From Baseline in the IDS-C30 at Week 6|The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement.|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
2775348|NCT00705003|Secondary|The Change From Baseline in the CGI-S at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient's clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time.~Possible responses include the following:~0: Not Assessed~Normal, not ill at all~Borderline mentally ill~Mildly ill~Moderately ill~Markedly ill~Severely ill~Among the most extremely ill patients. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline."|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2775349|NCT00705003|Primary|The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient's clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S)~The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to Rate the patient's total improvement whether or not, in your judgment, it is due entirely to drug treatment. The Investigator was asked Compared to the patient's condition at the Baseline visit, please assign a rating to how much the patient changed. Responses for the CGI-I evaluation included the following categories:~0: Not Assessed~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Week 6|142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
2775350|NCT00704964|Primary|Number of Participants With Adherence to Therapy According to Physician Approximation|Adherence was based on physiciant's clinical judgment.|Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3||||Participants|||Number
2775351|NCT00704964|Primary|Number of Participants With Biometrical Adherence to Therapy|Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.|Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3||||Participants|||Number
2775359|NCT00704847|Secondary|Questionnaire to Assess Health-related Quality of Life|"Health-related quality of life was assessed by the EQ-5D questionnaire, which is a patient questionnaire for measure of health, developed by the EuroQol Group.The EQ-5D questionnaire was administered to patients in order to measure change in health-related quality of life (HRQoL) over 2 years.~The subjects marks on a VAS scale from 0 to 100 the number that best describes their health today (0 is worst imaginable health state and 100 is best imaginable health state).~The change from baseline in the EQ-5D VAS was calculated."|From baseline to month 24|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.|||percentage of change||Standard Deviation|Mean
2775360|NCT00704847|Secondary|Questionnaire to Assess Stiffness in the Signal Knee.|"WOMAC's stiffness subscore was used to assess the stiffness in the signal knee. WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of joint stiffness for when performing each daily function listed in the questionnaire. 0 is no stiffness (best), 100 is extreme stiffness (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 200. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less stiffness).~Patients were instructed not to take analgesics for 3 days prior to the WOMAC test."|Baseline to month 24|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.|||percentage of change||Standard Deviation|Mean
2775361|NCT00704847|Secondary|Questionnaire to Assess Function and Physical Activity|"Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 1992):~I. Completely able to perform usual activities of daily living (self-care, vocational and avocational) II. Able to perform usual self-care and vocational activities, but limited in avocational activities.~III. Able to perform usual self-care activities, but limited in vocational and avocational activities.~IV. Limited ability to perform usual self-care activities, vocational and avocational activities.~Self-care activities included dressing, feeding, bathing, grooming, and toileting. Avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities were patient-desired and age- and sex-specific."|From baseline to months 1, 6, 12 and 24|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.|||percentage of change||Standard Deviation|Mean
2775362|NCT00704847|Secondary|Knee Disease Progression Assessed by MRI|Knee cartilage volume and thickness was assessed by MRI in patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.|From baseline to month 12 and month 24|Subset of patients from the sites in Ballerup (Denmark), Czech Republic and Romania|||percentage of change||Standard Deviation|Mean
2775363|NCT00704847|Secondary|Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).|The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24.|From baseline to 24 months|The number of participants analysed for these outcomes were a total of 150 subjects from the intent-to-treat (ITT) population evenly distributed across sites, all with completed baseline as well as all follow-up visits.|||percentage of change||Standard Deviation|Mean
2775364|NCT00704847|Primary|Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Standard Deviation|Mean
2775365|NCT00704847|Primary|Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||mm||Standard Deviation|Mean
2775366|NCT00704808|Primary|Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme||After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide|Intent-to-Treat population|||Months||Standard Error|Median
2775367|NCT00704769|Primary|General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments|Physicians judged the subjects as good, excellent, fair, or poor.|Minimum of 7 days after initiation of desloratadine||||Participants|||Number
2775425|NCT00703937|Primary|Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC|Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent|First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer||||participants|||Number
2775368|NCT00704769|Primary|Adverse Events|An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.|Minimum of 7 days after initiation of desloratadine||||Participants|||Number
2775369|NCT00704730|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.|Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.|||% of participants|||Number
2775370|NCT00704730|Secondary|Biochemical Response Calcitonin (CTN) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.|Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.|||% participants|||Number
2775371|NCT00704730|Secondary|Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined|For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.|From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.|The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.|||months||95% Confidence Interval|Median
2775372|NCT00704730|Secondary|Objective Response Rate (ORR)|The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR|Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.|The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders.|||% of participants|||Number
2775373|NCT00704730|Secondary|Overall Survival (OS) With XL184 Compared With Placebo|Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.|The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.|Intent to treat (ITT) randomized to either XL184 or placebo|||months||95% Confidence Interval|Median
2775374|NCT00704730|Primary|Progression-Free Survival (PFS)|The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.|Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.|Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.|||months||95% Confidence Interval|Median
2775476|NCT00703729|Secondary|Use of Pain Medication on Day 5|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775375|NCT00704717|Primary|Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.|The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.|The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.||||Units on a scale||Standard Deviation|Mean
2775376|NCT00704535|Primary|Tolerability as Measured by Subject Self-assessment|Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment|28 days after Visit 1||||subjects|||Number
2775377|NCT00704535|Primary|Safety as Measured by Outcome of Adverse Events|To evaluate overall safety of ezetimibe as measured by outcome of adverse events|28 days after Visit 1||||adverse events|||Number
2775378|NCT00704535|Primary|Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event|To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event|28 days after Visit 1||||adverse event|||Number
2775379|NCT00704535|Primary|Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.|To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.|28 days after Visit 1||||adverse events|||Number
2775380|NCT00704535|Primary|Safety as Measured by Severity of Adverse Events as Determined by the Investigator|To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator|28 days after Visit 1||||adverse events|||Number
2775381|NCT00704535|Primary|Safety as Measured by Number and Type of Adverse Events.|Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.|28 days after Visit 1||||adverse events|||Number
2775382|NCT00704535|Secondary|To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)|Change in mean total cholesterol values|28 days after Visit 1|All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements|||mg/dL||Standard Deviation|Mean
2775383|NCT00704535|Primary|Safety as Measured by Number of Subjects With at Least One Adverse Event|Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event|28 days after Visit 1||||subjects|||Number
2775384|NCT00704522|Primary|Average Length of Treatment With PegIntron/Rebetol||After start of treatment|Number of participants who received study drug|||Weeks||Standard Deviation|Mean
2775385|NCT00704522|Primary|Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program||24 or 48 weeks (depending on genotype) and 24 weeks of follow up|All participants|||Participants|||Number
2775386|NCT00704496|Secondary|Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo|daytime sleepiness by subjective questionnaires|3 years|data disposed of and no longer in existence||||||
2775387|NCT00704496|Primary|Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo|sleep improvement by subjective questionnaires|3 years|data disposed of and no longer in existence||||||
2775388|NCT00704418|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses|Day 1|LOCF Analysis, ITT Population|||participants|||Number
2775389|NCT00704418|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis(LOCF), ITT Population|||participants|||Number
2775390|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.|The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.|Week 48|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
2775391|NCT00704405|Secondary|Percentage of Participants Achieving cEVR|The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.|Up to Week 60|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.|||Percentage of participants|||Number
2775392|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.|The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.|72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
2775393|NCT00704405|Primary|Number of Participants Discontinuing From Study Treatment Due to AEs|The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.|Up to 48 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.|||Number of participants|||Number
2775394|NCT00704405|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|Up to 73 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.|||Number of participants|||Number
2775395|NCT00704405|Primary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.|The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.|Up to 72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
2775396|NCT00704379|Secondary|Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)|"FA is a measured obtained from Diffusion Tensor Imaging, an image modality of Magnetic Resonance Imaging (MRI). FA is a unitless index. Range: 0 to 1. FA describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted or equally restricted in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. In the context of this study, FA measures the integrity of the cingulate gyrus white matter. Higher FA values reflect higher integrity of the cingulate gyrus white matter tract. Average FA values for the right and left cingulate gyri were summed.~One aim of this project was to identify predictors of the occurrence of mood disturbances during the first 6 months following TBI. The hypothesis for this aim was that patients who develop a mood or anxiety disorder six months after TBI present at baseline with lower FA of the cingulate gyrus than those who do not."|Baseline|Of the 94 participants randomized, only 61 participants had an MRI and were included in the analysis of this study aim.|||unitless index||Standard Deviation|Mean
2775397|NCT00704379|Secondary|Social Functioning Examination Total Score|The Social Functioning Examination (SFE) is a semi-structured interview that measures social functioning in areas such as interpersonal relationships, work adjustment, use of community resources and satisfaction with living environment. Range: 0 to 1. Higher scores denote lower levels of social functioning.|6 months after TBI|Out of the 80 participants who completed the trial, only 63 completed SFE at this evaluation time.|||units on a scale||Standard Deviation|Mean
2775398|NCT00704379|Secondary|Memory Function Composite|This outcome measures memory function and is a composite of five standardized scores: Brief Visuospatial Memory Test - Revised, Delayed Recall and California Verbal Learning Test, Short Delay Free Recall Number Correct and Discriminability, and Long Delay Free Recall Number Correct and Discriminability. Standardized scores (i.e., z-scores) for each test of this composite were obtained by subtracting the mean raw score of all participants to the raw score of each participant and dividing the result by the standard deviation of the raw scores of all participants. The composite score was obtained by averaging the z-scores of the four memory tests mentioned previously. Range: -3 to 3. Higher scores represent better memory function.|6 months following traumatic brain injury|Out of the 80 participants who completed the trial, only 61 completed all the tests necessary to calculate the composite score at this evaluation time.|||z-scores||Standard Deviation|Mean
2775399|NCT00704379|Secondary|Iowa Gambling Task Score|The Iowa Gambling Task (IGT) evaluates decision making ability. During IGT subjects have to choose between decks of cards which yield high immediate gain but larger future loss (i.e., long term loss), and decks which yield lower immediate gain but a smaller future loss (i.e., a long term gain). The task consists of four decks of cards: A, B, C, and D. The goal in the task is to maximize profit. Subjects are required to make a series of card selections. The decks A and B are long term loss decks and the decks C and D are long term gain decks. The IGT Score reported is the combination of the raw score for each deck combined in the following way: (C+D) - (A+B). The range for this score is: -100 to 100. Higher values of this score indicate better decision making ability.|6 months after TBI|Out of the 80 participants who completed the trial, only 64 completed IGT at this evaluation time.|||units on a scale||Standard Deviation|Mean
2775400|NCT00704379|Secondary|Total Community Integration Questionnaire Scores|The Community Integration Questionnaire (CIQ) is intended as a brief, reliable measure of an individual's level of integration into the home and community following traumatic brain injury. Total CIQ scores were used as the outcome measure. Range: 0 to 25. Higher scores indicate higher levels of integration into the home and community following TBI.|6 months after TBI|Out of the 80 participants who completed the trial, only 68 completed CIQ at this evaluation time.|||units on a scale||Standard Deviation|Mean
2775401|NCT00704379|Primary|Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)|"Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode [MDE] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder).~On the other hand, bipolar and related disorders due to TBI are subdivided in: 1) with manic or hypomanic like episode; 2) with manic features; and 3) with mixed features.~A similar conceptual framework has been used to define Anxiety Disorder due to another Medical Condition, in this case, TBI. According to DSM-IV/DSM-5, such diagnosis can be made when, besides an evident pathophysiological relationship with TBI, panic attacks or generalized anxiety are the prominent features of the clinical presentation."|6 months after TBI||||weeks||Standard Error|Mean
2775402|NCT00704353|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)||through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)||||participants|||Number
2775403|NCT00704340|Secondary|Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak|"As determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation~CSF leak confirmation by diagnostic testing within 30 days post-operation~CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation"|30 days||||percent of subjects||95% Confidence Interval|Number
2775404|NCT00704340|Secondary|Percentage of Subjects With Post-operative Surgical Site Infections||30 days||||percent of subjects||95% Confidence Interval|Number
2775477|NCT00703729|Secondary|Use of Pain Medication on Day 4|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775405|NCT00704340|Primary|Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.|"Surgical Wound Complications;~Superficial incisional surgical site infection (SSI)~Deep incisional SSI~Organ/Space SSI~Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery~Poor wound healing~Central Nervous System Events;~Cerebrospinal Fluid (CSF) leak~Hydrocephalus~Bacterial meningitis~Aseptic meningitis~In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted."|30 days||||percent of subjects||95% Confidence Interval|Number
2775406|NCT00704184|Secondary|Mean Log Change From Baseline in HCV RNA|The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Log10 IU/mL||Standard Deviation|Mean
2775407|NCT00704184|Secondary|Number of Participants With ≥3-log10 Decrease in HCV RNA|The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Number of Participants|||Number
2775408|NCT00704184|Secondary|Number of Participants With ≥2-log10 Decrease in HCV RNA|The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Number of Participants|||Number
2775409|NCT00704184|Primary|Number of Participants Discontinuing From Study Therapy Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.|Day 1 to Day 28|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy|||Participants|||Number
2775410|NCT00704184|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.|Up to Day 42|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.|||Participants|||Number
2775411|NCT00704184|Primary|Percentage of Participants Achieving RVR|Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.|Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Percentage of Participants|||Number
2775412|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge|Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles|30 days|Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.|||Percentage of participants|||Number
2775413|NCT00704171|Secondary|Duration of Hospitalization||30 days||||hours||Standard Deviation|Median
2775414|NCT00704171|Secondary|Duration of Chest Drainage||30 days||||hours||Standard Deviation|Median
2775415|NCT00704171|Secondary|Time From Skin Closure to Last Observable Air Leak.||30 days||||hours||95% Confidence Interval|Median
2775416|NCT00704171|Secondary|Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.|Success is defined as no presence of air leak intra-operatively.|Intra-operatively, time of study procedure||||Percentage of participants|||Number
2775417|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.||30 days||||Percentage of participants|||Number
2775418|NCT00704132|Primary|Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6|Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.|Baseline and Week 6|Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.|||mg*hr/dL||95% Confidence Interval|Least Squares Mean
2775419|NCT00704028|Primary|The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)||Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer||||participants|||Number
2775420|NCT00703976|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|2 years of follow-up after closing accrual||||percentage of participants||95% Confidence Interval|Number
2775421|NCT00703976|Primary|2-year Progression-free Survival (PFS)|Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.|18 months to patient accrual and 2 years of follow-up after closing accrual.||||percentage of participants||90% Confidence Interval|Number
2775422|NCT00703963|Secondary|Mean Number of INR Tests Performed||baseline to 3 months||||INR tests||Standard Deviation|Mean
2775423|NCT00703963|Secondary|Mean Percentage of INR Tests Within the Therapeutic Range||baseline to 3 months||||percentage of tests||Standard Deviation|Mean
2775424|NCT00703963|Primary|Mean Percentage of Time in Therapeutic Range||baseline to 3 months||||percentage of time||Standard Deviation|Mean
2775426|NCT00703924|Secondary|Rate of Relapse|"Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher's exact test.~Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable."|180 days||||Participants|||Count of Participants
2775427|NCT00703924|Secondary|Final Cure Rate by Subject of All Lesions|Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.|180 days||||Participants|||Count of Participants
2775428|NCT00703924|Secondary|Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse|100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.|180 days|Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization|||Participants|||Count of Participants
2775429|NCT00703924|Primary|Safety of WR 279,396 (AEs and SAEs)|Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.|180 days|All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized.|||Adverse Events|||Number
2775430|NCT00703924|Primary|Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)|CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups|180 days||||Participants|||Count of Participants
2775431|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775432|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (All Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775433|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775434|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (All Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775435|NCT00703911|Secondary|Adults' Health Related Quality of Life (Haemo-QoL-A): Overall Score|The adult Haemo-QoL-A is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of adult subjects above 16 years included in the study that completed the questionnaire at baseline and/or at discontinuation|||scores on a scale||Standard Deviation|Mean
2775436|NCT00703911|Secondary|Childrens' Health Related Quality of Life (Haemo-QoL): Overall Score|The Haemo-QoL is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of paediatric subjects age 4 to 16 (inclusive) included in the study that completed the questionnaire at baseline and/or at discontinuation|||scores on a scale||Standard Deviation|Mean
2775449|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes)|Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775437|NCT00703911|Secondary|Overall Time to Cessation/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable.|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose, excluding bleed episodes treated with more than one dose for which > 24 hours between the 1st and 2nd dose was reported (bleed episodes with > 24 hours between 1st and 2nd rFVIIa dose likely reflects treatment of re-bleeding or prophylactic/maintenance dosing)|||minutes||95% Confidence Interval|Median
2775438|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||minutes||95% Confidence Interval|Median
2775439|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (All Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||minutes||95% Confidence Interval|Median
2775440|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (Spontaneous Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775441|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (All Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775442|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Symptom Relief (Spontaneous Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775443|NCT00703911|Secondary|Percentage of Patients Reporting Satisfaction With Symptom Relief (All Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775444|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (Spontaneous Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes. Excludes bleeds episodes with > 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing, and 2 bleed episodes categorised as CNS that would not meet criteria of mild to moderate spontaneous bleed episodes|||mcg/kg||Full Range|Median
2775445|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (All Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level. Excludes bleeds episodes with greater than 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing|||mcg/kg||Full Range|Median
2775446|NCT00703911|Secondary|Total Number of Injections (Spontaneous Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||injections||Inter-Quartile Range|Median
2775447|NCT00703911|Secondary|Total Number of Injections (All Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||injections||Inter-Quartile Range|Median
2775448|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes)|Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775475|NCT00703729|Secondary|Use of Pain Medication on Day 6|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775450|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775451|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775452|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775453|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775454|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
2775455|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
2775456|NCT00703885|Primary|Voxelwise Brain Imaging Data|Analysis of data not completed.|Post-Rx Administration|||||||
2775457|NCT00703885|Primary|Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing|Analysis not completed.|Same Day|||||||
2775458|NCT00703846|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the functional component, participants were asked to answer 15 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of the 12 question scores; total score ranges from 15 to 75.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2775459|NCT00703846|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the emotional component, participants were asked to answer 10 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of the 10 question scores; total score ranges from 10 to 50.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2775460|NCT00703846|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the symptomatic component, participants were asked to answer 7 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of the 7 question scores; total score ranges from 7 to 35.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2775461|NCT00703846|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2775462|NCT00703846|Secondary|Median Number of Flare Days|The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.|From baseline through 52 weeks|Safety Analysis Set|||flare days||Full Range|Median
2775463|NCT00703846|Secondary|Median Number of Flares|The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.|From baseline through 52 weeks|Safety Analysis Set|||flares||Full Range|Median
2775464|NCT00703846|Secondary|Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|"This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time (static). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness."|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
2775465|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
2775466|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
2775467|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
2775468|NCT00703846|Primary|Number of Participants With Any Adverse Event (AE)|"An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled Other (Non-Serious) Adverse Events."|From baseline through 52 weeks|Safety Analysis Set: all participants who had used the study product at least once|||participants|||Number
2775469|NCT00703820|Secondary|Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.||3 years after completion of therapy|||||||
2775470|NCT00703820|Secondary|Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.||3 years after completion of therapy|||||||
2775471|NCT00703820|Primary|Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry|MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.|Day 22 MRD measurement after one course of therapy|Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.|||Participants|||Count of Participants
2775472|NCT00703781|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop|Day 1|LOCF Analysis, ITT Population|||Participants|||Number
2775473|NCT00703781|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)|||Participants|||Number
2775474|NCT00703729|Secondary|Use of Pain Medication on Day 7|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775478|NCT00703729|Secondary|Use of Pain Medication on Day 3|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775479|NCT00703729|Secondary|Use of Pain Medication on Day 2|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775480|NCT00703729|Primary|Patient Reported Pain on Day 7|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775481|NCT00703729|Primary|Patient Reported Pain on Day 6|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775482|NCT00703729|Primary|Patient Reported Pain on Day 5|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775483|NCT00703729|Primary|Patient Reported Pain on Day 4|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775484|NCT00703729|Primary|Patient Reported Pain on Day 3|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775485|NCT00703729|Primary|Patient Reported Pain on Day 2|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775486|NCT00703729|Primary|Patient Reported Pain on Day 1|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775487|NCT00703729|Secondary|Use of Pain Medication on Day 1|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
2775488|NCT00703729|Primary|Patient Reported Pain on Day 0|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
2775489|NCT00703677|Secondary|Geriatric Depression Scale(GDS)-15:Change From Baseline|The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28.|28 weeks|||||||
2775490|NCT00703677|Secondary|Frontal Assessment Battery (FAB): Change From Baseline|The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28.|28 weeks|||||||
2775491|NCT00703677|Secondary|PSP-Quality of Life Scale (QoL):Change From Baseline|The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks|||||||
2775492|NCT00703677|Secondary|Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline|The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28.|28 weeks|||||||
2775493|NCT00703677|Secondary|PSP Rating Scale Score: Change From Baseline|The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks|||||||
2775494|NCT00703677|Secondary|Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity|Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28|28 weeks|Due to the very small number of samples collected, samples were not analyzed.||||||
2775495|NCT00703677|Secondary|Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF|With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed||||||
2775496|NCT00703677|Secondary|Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)|Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed||||||
2775497|NCT00703677|Secondary|Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant.|28 weeks|All subjects were evaluated for compliance.|||Subjects|||Number
2775498|NCT00703677|Primary|Ability to Tolerate Lithium Carbonate|The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.|28 weeks|One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability.|||Subject|||Number
2775499|NCT00703664|Secondary|Duration of Stable Disease|Median duration of stable disease per cohort.|Up to 9 years|All participants with stable disease.|||months||Full Range|Median
2775500|NCT00703664|Secondary|Duration of Partial Response|Median duration of response per cohort.|Up to 9 years|All participants with Partial Response.|||months||Full Range|Median
2775502|NCT00703664|Secondary|Best Response|Number of participants per category: Partial Response (PR), Stable Disease (SD), Progressive Disease (PD). PR: Regression of measurable disease and no new sites. SD: Failure to attain Complete Response (CR), /PR or PD. Relapsed or Progressive Disease: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.|Up to 9 years|All participants evaluable and available at time of assessment.|||Participants|||Count of Participants
2775503|NCT00703664|Primary|Overall Response Rate (ORR)|ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.|Up to 9 years|All participants.|||percentage of participants|||Number
2775504|NCT00703534|Primary|Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary|Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)|Run-in period of 8-12 days and treatment period of 26-30 days|None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.|||participants|||Number
2775505|NCT00703508|Secondary|Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.|Bivariate fit (RSquare with P values) of ovulation rate post treatment by change in total testosterone and Matsuda Index for each of the 3 genotypes (G/G, C/G, C/C)|9 months|Individuals that were lost to follow up had missing data on testosterone and OGTT (oral glucose tolerance testing) for Matsuda index.|||Correlation coefficient (r^2)|||Number
2775506|NCT00703508|Primary|Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG|Ovulations were determined by measurement of daily urine pregnanediol-3-glucuronide or weekly progesterone levels over 6-9 months of study duration for each participant. The ovulation rate was calculated as the number of confirmed ovulation events per months of study participation.|9 months||||ovulations/month||Standard Deviation|Mean
2775507|NCT00703508|Primary|Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)|Responders were defined as those that had a doubling of baseline ovulation rate estimated by self-report of menstrual history.|9 months||||participants|||Number
2775508|NCT00703391|Primary|Renal Clearance of Drug From Plasma (CLR)|CLR following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||L/h||Full Range|Geometric Mean
2775509|NCT00703391|Primary|Terminal Half-life of Drug in Plasma (t1/2)|t1/2 following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||hours||Full Range|Median
2775510|NCT00703391|Primary|Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)|tmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||hours||Full Range|Median
2775511|NCT00703391|Primary|Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)|Cmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||nM||Full Range|Geometric Mean
2775512|NCT00703391|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))|AUC(0-12) following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||nM.h||Full Range|Geometric Mean
2775513|NCT00703391|Primary|FEV1 (Forced Expiratory Volume in the First Second)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||L||Standard Deviation|Mean
2775514|NCT00703391|Secondary|Quantitative Sputum Bacteriology|Number of patients with an increase in bacteriological count from Day -1 to Day 15|Pre-dose day -1 to post-dose on day 15||||Participants|||Number
2775515|NCT00703391|Secondary|AZD9668 Sputum Concentrations||Pre-dose day -1 to post-dose on day 14||||nM||Full Range|Geometric Mean
2775516|NCT00703391|Secondary|Sputum Differential Neutrophil Count|Change from baseline to Day 14 in percentage neutrophil count|Pre-dose day -1 to post-dose on day 14||||Percentage||Full Range|Median
2775517|NCT00703391|Secondary|Sputum Absolute Neutrophil Count|Change from baseline to Day 14 in absolute neutrophil count|Pre-dose day -1 to post-dose on day 14||||10**9/L||Full Range|Median
2775518|NCT00703391|Primary|QTcF|QTcF change from baseline greater than 60 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
2775519|NCT00703391|Primary|QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)|QTcF interval greater than 450 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
2775520|NCT00703391|Primary|Leucocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||10**9/L||Standard Deviation|Mean
2775521|NCT00703391|Primary|Reticulocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||relative particle count (%)||Standard Deviation|Mean
2775522|NCT00703391|Primary|Haemoglobin (Hb)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||g/L||Standard Deviation|Mean
2775523|NCT00703391|Primary|Creatinine|Creatinine level greater than the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
2775524|NCT00703391|Primary|Total Bilirubin|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||micromol/L||Standard Deviation|Mean
2775525|NCT00703391|Primary|Creatine Kinase (CK)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||IU/L||Standard Deviation|Mean
2775526|NCT00703391|Primary|Aspartate Aminotransferase (AST)|AST level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
2775527|NCT00703391|Primary|Alanine Aminotransferase (ALT)|ALT level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
2775557|NCT00703118|Secondary|Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4|RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
2775528|NCT00703339|Secondary|Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.|PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.|acute|Insufficient enrollment, therefore no participants were analyzed.||||||
2775529|NCT00703339|Primary|Safety and Tolerability of Inhaled Treprostinil Sodium in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis,Reported as Number of Participants With Adverse Events|Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.|3-5 days|Insufficient enrollment, therefore no Participants were analyzed.||||||
2775530|NCT00703326|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module.|First dose to study completion (up to 49 months) plus 30-day safety follow-up|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2775531|NCT00703326|Other Pre-specified|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The overall percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.|Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event until data cutoff of 31-Mar-2013 (up to 31 months)|All randomized participants who received at least 1 dose of study drug with anti-IMC-1121B antibodies samples collected during the study.|||percentage of participants|||Number
2775532|NCT00703326|Secondary|Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL.|Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 42 months)|A subset of Intent-to-Treat (ITT) Population: all randomized participants with a valid baseline and end of therapy assessments.|||units on a scale||Standard Deviation|Mean
2775533|NCT00703326|Secondary|Duration of Response|Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as ≥30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as ≥20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of ≥1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after ≥2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression.|Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 35 months)|A subset of the Intent-to-Treat (ITT) Population: all randomized participants with CR or PR. Censored participants: ramucirumab + docetaxel=80, placebo + docetaxel=28.|||months||95% Confidence Interval|Median
2775534|NCT00703326|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2775535|NCT00703326|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=263, placebo + docetaxel=104.|||months||95% Confidence Interval|Median
2775536|NCT00703326|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death or until data cutoff of 31-Mar-2013 (up to 49 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=448, placebo + docetaxel=225.|||months||95% Confidence Interval|Median
2775537|NCT00703326|Primary|Progression-Free Survival (PFS)|PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=231, placebo + docetaxel=94.|||months||95% Confidence Interval|Median
2775538|NCT00703261|Secondary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all statin-naive participants who completed the study and had complete image sets.|||Percent reduction||90% Confidence Interval|Geometric Mean
2775539|NCT00703261|Primary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all participants who completed the study and had complete image sets with usable data.|||Percent reduction||90% Confidence Interval|Geometric Mean
2775540|NCT00703157|Secondary|Left Atrial Dimension and Contractility||Through 24 months post-ablation|Data were not collected||||||
2775541|NCT00703157|Secondary|Reduced Anti-arrhythmic Drug Requirement||Through 24 months post-ablation|Data were not collected||||||
2775542|NCT00703157|Secondary|Assessment of AF Burden||Through 24 months post-ablation|Data were not collected||||||
2775543|NCT00703157|Secondary|Occurences of Treatment of Arrhythmic Episodes||Through 24 months post-ablation|Data were not collected||||||
2775544|NCT00703157|Secondary|Symptoms Associated With Atrial Arrhythmias||Through 24 months post-ablation|Data were not collected||||||
2775545|NCT00703157|Secondary|Reduced Number, Duration and Severity of AF Symptoms||Through 24 months post-ablation|Data were not collected||||||
2775546|NCT00703157|Secondary|Duration, Burden and Costs of Treatment Procedures||Through 24 months post- ablation|Data were not collected||||||
2775547|NCT00703157|Secondary|Mortality and Hospitalization||Time from procedure until 24 months post-ablation||||participants|||Number
2775548|NCT00703157|Secondary|Number of Subjects With Adverse Events, Associated With the Ablation Procedure||Time from procedure||||Participants|||Count of Participants
2775549|NCT00703157|Secondary|Treatment Failures Requiring Redo or Alternative Therapy||Time from procedure until 6 months post-ablation||||Participants|||Count of Participants
2775550|NCT00703157|Primary|Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.|AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.|Baseline through 3-6 months post-ablation||||percentage of time in AF||Standard Deviation|Mean
2775551|NCT00703118|Secondary|Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12|Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.|Week 4 and Week 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
2775552|NCT00703118|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4||Baseline (Day 1) to Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||log10 IU/mL||Standard Deviation|Mean
2775553|NCT00703118|Secondary|Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)|Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).|Up to Week 72|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
2775554|NCT00703118|Secondary|Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8|Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.|Week 4, Week 6, or Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
2775555|NCT00703118|Secondary|Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned|SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).|Week 60|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
2775556|NCT00703118|Secondary|Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)||Week 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
2775558|NCT00703118|Primary|Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned|SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.|Week 72|Full Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Number
2775559|NCT00703092|Secondary|Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.||||||
2775560|NCT00703092|Primary|Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.||||||
2775561|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses|The kinetics of the antibody response to vaccination with A/Vietnam/04 is evaluated by the HAI GMT against the A/Vietnam/04 antigen at weekly intervals after receipt of 2 doses 7, 14 and 28 days apart|Weeks 1, 2, 3 and 4 after the second dose|Analyses are based on a modified intent to treat population. 5 subjects in the VN/VN, Day 0, 28 group not receiving vaccination 2 are excluded, as were 2, also in this group, due to receipt of prohibited vaccines.|||Titer||95% Confidence Interval|Geometric Mean
2775562|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775563|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775564|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. The CI shown as 5.0 to 5.0 reflect that all subjects had a titer of 5.0 for the VN,VN, Day 0,14 and VN, Day 0 groups.|Six months after last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775565|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775566|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775567|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775568|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775569|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775570|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775571|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775572|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775573|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775574|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
2775575|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775576|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775577|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after the second vaccination and review the Memory Aid with clinic staff at a follow up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after second vaccination|All subjects receiving the second vaccination are included in this outcome measure. The VN, Day 0 Group received only one dose.|||Participants|||Number
2775642|NCT00702689|Secondary|Total Chronic Graft Versus Host Disease (cGVHD) Provider Global Rating Score at Baseline and 6 Months|The provider global rating is a physician impression of severity of cGVHD symptoms from a scale of zero (no symptoms) to 10 (most severe GVHD symptoms possible).|Baseline and 6 months||||Provider Global Rating Score|||Number
2775578|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after first vaccination|All subjects receiving the first vaccination are included in the safety population and analyses of safety are ITT. Three subjects were randomized but not vaccinated.|||Participants|||Number
2775579|NCT00703053|Secondary|Number of Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 180 days after the last vaccination.|Duration of study|All subjects receiving at least one study vaccination are included in the safety population and analyses of safety are intention to treat (ITT). Three subjects were randomized but not vaccinated.|||Events|||Number
2775580|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
2775581|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Percentage of Participants|||Number
2775582|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Percentage of Participants|||Number
2775583|NCT00703014|Primary|Number of Infants in Current Follow Up Trial Experiencing SAEs|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.|||Participants|||Number
2775584|NCT00703014|Primary|Number of Infants Born in Current Follow Up Trial Experiencing AEs|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.|||Participants|||Number
2775585|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Participants|||Number
2775586|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Participants|||Number
2775587|NCT00702962|Secondary|To Assess the Safety Profile and Define the Toxicities of Using a Fixed Dose (300mg) of Vorinostat With Carboplatin and Etoposide|Evaluation of resultant adverse events that occurred with participants with extensive disease SCLC after initiating treatment using a fixed dose of vorinostat in combination with carboplatin and etoposide.|2 years, not analyzed|One participant enrolled in the Phase II portion and discontinued treatment prematurely due to concurrent health issues and hospitalization. No unanticipated adverse events occurred while on study. The study closed prematurely due to low accrual. No analysis conducted.||||||
2775596|NCT00702949|Secondary|Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment||||percent change||95% Confidence Interval|Median
2776270|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg|Cumulative refers to achieving of blood pressure control before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)|||Percentage of Participants|||Number
2775588|NCT00702962|Secondary|Evaluate Objective Response Rate Among Patients With Extensive Disease SCLC Receiving Carboplatin and Etoposide With a Fixed Dose of Vorinostat.|Eligibility limits the study population to those who have measurable disease pre-treatment. This secondary outcome measure was intended to objectively evaluate disease response and survival rate in recipients of the investigational medication regimen. Disease response was performed using standard diagnostic imaging. Tumor markers and cytology may be used to support the imaging results. Objective response rate was defined as progression-free survival (PFS) among treatment recipients. PFS, is defined as time (in months) from entry to clinical evidence of disease progression or death without progression. The clinical trial closed prematurely due to low accrual. For this reason, an analysis of this secondary objective would not be meaningful. No analysis done.|2 years, not analyzed|One participant enrolled and treated in the Phase II portion. Participant rendered off treatment and off study prior to completion due to concurrent health disorders. The clinical trial closed prematurely due to low accrual. For this reason, an analysis of this secondary objective would not be meaningful. No analysis done.||||||
2775589|NCT00702962|Secondary|To Evaluate Overall Survival of Patients With Extensive Disease SCLC Receiving Carboplatin, Etoposide, and a Fixed Dose (300mg) of Vorinostat|For the purpose of this study, overall survival is defined as the percentage of participants who are alive at two years post initiation of study treatment.|2 years, not analyzed|One participant enrolled on Phase II. Off treatment and off study prematurely due to concurrent health disorders.||||||
2775590|NCT00702962|Primary|Assess Maximum Tolerated Dose of Vorinostat When Combined With Carboplatin and Etoposide of Patients With Extensive Disease SCLC|"To estimate the maximum tolerated dose of vorinostat using a traditional dose escalation schedule (3 + 3 design). MTD is determined by assessing for specific predefined dose limiting toxicities. A starting dose of vorinostat 200mg was combined with carboplatin and etoposide. Dose escalation went in increments of 100mg (i.e. 300mg, 400mg)."|2 years, not analyzed|The first three participants enrolled were treated at dose level 1 (vorinostat 200 mg). Phase I protocol closed prematurely with no additional subjects enrolled. No analysis due to premature closure.||||||
2775591|NCT00702949|Secondary|Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment|Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.|Baseline, after week 6 of treatment.||||units on a scale||Full Range|Median
2775592|NCT00702949|Primary|Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||percent change||95% Confidence Interval|Median
2775593|NCT00702949|Secondary|Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .|A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).|Baseline, 6 weeks during treatment.||||units on a scale||Full Range|Median
2775594|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||percent change||95% Confidence Interval|Median
2775595|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||units on a scale||95% Confidence Interval|Median
2775626|NCT00702780|Primary|% Change of Whole Brain Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.|||percentage of change||Standard Deviation|Mean
2775597|NCT00702949|Secondary|Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment||||Hot flashes per day||95% Confidence Interval|Median
2775598|NCT00702949|Primary|Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||units on a scale||95% Confidence Interval|Median
2775599|NCT00702923|Secondary|Number of Participants With PSA Recurrence.|PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.|one year||||participants|||Number
2775600|NCT00702923|Secondary|The Number of Participants With an Increase in PSA Doubling Time||Up to 18 months after last dose of study agent||||participants|||Number
2775601|NCT00702923|Primary|The Number of Participants Who Developed Cancer Antigen-specific Immune Responses||Up to 12 months after treatment with study agent||||participants|||Number
2775602|NCT00702884|Secondary|Quantitative Assessment of Proliferating Tumor Cells and Apoptosis|Biopsy sample taken from patients before and after treatment Apoptosis measures using the terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay, which measures 3' nicked DNA. DNA is degraded in the early steps of apoptosis into low molecular weight (LMW) fragments and the production of single strand breaks in the high molecular weight DNA.Both of these features of apoptosis can be detected by labeling free 3'-OH termini with modified nucleotides, in our case this will be biotin-labeled dUTP. Terminal deoxynucleotidyl transferase (TdT) is an enzyme that labels blunt-ends of DNA breaks and can catalyze polymerization of nucleotides to free 3'-OH DNA ends in a template-independent manner. The newly incorporated nucleotides are detected by a secondary antibody, avidin-peroxidase. After substrate reaction, the stained cells can be detected and counted under a light microscope. Apoptotic cells will be fixed with formaldehyde which links LMW DNA|up to 4 years|Analysis for tumor cells not performed due to insufficient samples available||||||
2775603|NCT00702884|Secondary|Change in Mean Vessel Density|Quantitative assessment of proliferating tumor cells, and apoptosis, of the laboratory and radiographic correlates, the analyses will be purely explorative.|up to 4 years|Insufficient tissue was available and the analysis for mean vessel density not performed||||||
2775604|NCT00702884|Secondary|Frequency and Severity of Adverse Events|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.|up to 4 years||||percentage of patients|||Number
2775605|NCT00702884|Secondary|Median Progression-free Survival Time|Progression free survival was measured as the time from start of treatment to the first measurement of tumor growth.|up to 4 years||||weeks||95% Confidence Interval|Median
2775606|NCT00702884|Secondary|Median Overall Survival Time|The median overall survival time will be reported using the 95% confidence intervals for the parameters.|up to 4 years||||weeks||95% Confidence Interval|Median
2775607|NCT00702884|Secondary|Overall Response Rate|The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|up to 4 years|Durable Complete Response= PR + SD > 10 weeks|||patients|||Number
2775608|NCT00702884|Primary|Progression-free Survival Rate|Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks|up to 24 weeks||||weeks||95% Confidence Interval|Median
2775609|NCT00702845|Secondary|Number of Participants With Pregnancies|A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.|Up to 10 weeks after ET (up to a maximum of 14 weeks)|ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.|||Participants|||Number
2775610|NCT00702845|Secondary|Number of Participants With Miscarriages|"A miscarriage, also known as a spontaneous abortion, was defined as the loss of a fetus without induction or instrumentation."|Up to 10 weeks after ET (up to a maximum of 14 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.|||Participants|||Number
2775611|NCT00702845|Secondary|Implantation Rate for Participants With ET|The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.|Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.|||Percentage||Standard Deviation|Mean
2775627|NCT00702780|Primary|% Change of Hippocampus Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.|||percentage of change||Standard Deviation|Mean
2775612|NCT00702845|Secondary|Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)|"Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. Other grade embryos were those that did not qualify as Grade 1, 2, or 3."|Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.|||Number of embryos||Standard Deviation|Mean
2775613|NCT00702845|Secondary|Fertilization Rate|Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.|Up to 10 weeks after ET|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.|||Percentage||Standard Deviation|Mean
2775614|NCT00702845|Secondary|Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)|The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).|Up to 36 hours after administration of hCG|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.|||Number of oocytes||Standard Deviation|Mean
2775615|NCT00702845|Secondary|Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration|For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.|Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Follicles||Standard Deviation|Mean
2775616|NCT00702845|Secondary|Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||pg/mL||Full Range|Median
2775617|NCT00702845|Secondary|Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||nmol/L||Full Range|Median
2775618|NCT00702845|Secondary|Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||pmol/L||Full Range|Median
2775619|NCT00702845|Secondary|Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||IU/L||Full Range|Median
2775620|NCT00702845|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||IU/L||Full Range|Median
2775621|NCT00702845|Secondary|Total Duration of Stimulation (Days)|Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Days||Full Range|Median
2775622|NCT00702845|Secondary|Number of Days Treated With recFSH|Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Days||Full Range|Median
2775623|NCT00702845|Secondary|Total Dose of recFSH Administered From Day 8 Onwards|Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||International Unit (IU)||Full Range|Median
2775624|NCT00702845|Secondary|Total Dose of recFSH Administered|Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||International Unit (IU)||Full Range|Median
2775625|NCT00702845|Primary|Number of Cumulus-oocyte-complexes Retrieved, Per Attempt|The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.|One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)|Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.|||Number of cumulus-oocyte-complexes||Standard Deviation|Mean
2775628|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 8 (84 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775629|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 7 (72 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775630|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 6 (60 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775631|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 5 (48 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775632|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 4 (36 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775633|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 3 (24 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775634|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 2 (12 wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
2775635|NCT00702754|Primary|Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms|7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms|Session 1 - Time 0, 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Error|Mean
2775636|NCT00702715|Secondary|Time to Recovery of T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
2775637|NCT00702715|Secondary|Time to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
2775638|NCT00702715|Primary|Time to Recovery of the T4/T1 Ratio to 0.9.|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
2775639|NCT00702702|Primary|Change in Hemoglobin vs Placebo|Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3|3 months|Study prematurely terminated for safety reasons||||||
2775640|NCT00702689|Secondary|Change in Immunosuppression|Change in immunosuppression was defined by an increase or decrease in steroid use form baseline.|6 months|Pred:prednisone; tacro:tacrolimus; MPred:methylprednisolone; siro:sirolimus; and MMF:mycophenolate mofetil|||participants|||Number
2775641|NCT00702689|Secondary|Lung Function Score at Baseline and 6 Months|Lung function was graded by the National Institutes of Health Chronic Graft Versus Host Disease organ response criteria. The Lung function score = forced expiratory volume 1 (FEV1) score + carbon monoxide diffusing capacity (DLCO) score, with a possible range of 2 (better outcome)-12 (worst outcome). The percent predicted FEV1 and DLCO (adjusted for hematocrit but not alveolar volume) should be converted to a numeric score as follows: >80% =1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 40-49% = 5; <40% = 6.|Baseline and 6 Months||||units on a scale|||Number
2776271|NCT00698646|Secondary|Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Weeks 8, 12, and 16|Intent to treat (ITT), Last observation carried forward|||mm Hg||Standard Deviation|Mean
2775643|NCT00702689|Secondary|Total Skin Score at Baseline and 6 Months|Total skin score was graded by the National Institutes of Health Consensus Criteria. Skin score was calculated by dividing the total score by seven domains (skin, eye, oral, joint, gastrointestinal, hepatic, pulmonary) in men and 8 domains in women (previous domains noted plus gynecologic). Total skin score is a percentage of body surface area (BSA) involvement (range 0-100%). It was calculated from the sum of moveable body surface BSA and non-moveable BSA. Higher numbers = greater body surface area affected.|Baseline and 6 Months||||units on a scale|||Number
2775644|NCT00702689|Secondary|Average Percentage Change in Range of Motion (ROM) Deficit|One or more joints were assessed for ROM deficit by a physiatrist with expertise in graft versus host disease and joint ROM.|6 months|This outcome is the average percentage change in ROM deficit among 13 evaluable patients based on each patients baseline range of motion deficit compared to his/her ROM deficit at 6 months.|||Percent change||Inter-Quartile Range|Mean
2775645|NCT00702689|Secondary|Number of Participants With Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately, 41 months, 27 days||||Participants|||Number
2775646|NCT00702689|Primary|Primary Range of Motion (ROM) Response|Progressive disease is defined as joint ROM: decrease of >25% in composite ROM score on 2 consecutive evaluations at least 2 weeks apart, but not greater than 4 weeks apart or steroid pulse: >1 steroid pulse per 3 month period if administered for sclerotic-type chronic graft versus host disease (ScGVHD). Response is joint ROM: increase of >25% in composite ROM score. Maximal response is a response with no further improvement over 2 sequential 3-month evaluations. Stable disease does not meet the criteria for progression, response, or maximal response.|6 months||||participants|||Number
2775647|NCT00702689|Primary|Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 Months|A change in ROM is 25% or greater from baseline. A partial response required improvement in 25% or more in ROM. Progression required 25% or greater loss of ROM.Patients with negative values in the Table are those who lost ROM. Percent improvement in ROM for 1-3 target joints. For patients with >1 target joint, the average ROM improvement was calculated. The average percentage change in ROM deficit from baseline to 6 months was obtained based on the number of degrees of ROM change (6 months)/total ROM deficit (baseline) at each joint.|6 months||||Percent change from baseline|||Number
2775648|NCT00702650|Secondary|Change From Baseline to Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.|||units on a scale||Standard Deviation|Mean
2775649|NCT00702650|Secondary|Change From Baseline to Endpoint in Haematocrit|Haematocrit: percentage of total blood volume made up of blood cells|Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||percentage of red blood cells||Standard Deviation|Mean
2775650|NCT00702650|Secondary|Change From Baseline to Endpoint in Haemoglobin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||g/dL||Standard Deviation|Mean
2775651|NCT00702650|Secondary|Change From Baseline to Endpoint in Estradiol||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||pg/mL||Standard Deviation|Mean
2775652|NCT00702650|Secondary|Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||mIU/mL||Standard Deviation|Mean
2775653|NCT00702650|Secondary|Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)||Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.|||ng/mL||Standard Deviation|Mean
2775654|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Glucose||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||mg/dL||Standard Deviation|Mean
2775655|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Insulin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||uIU/mL||Standard Deviation|Mean
2775656|NCT00702650|Secondary|Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||units on a scale||Standard Deviation|Mean
2775657|NCT00702650|Secondary|Change From Baseline to Endpoint in Psychosexual Daily Questionnaire|Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||units on a scale||Standard Deviation|Mean
2775658|NCT00702650|Secondary|Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL|Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
2775659|NCT00702650|Secondary|Percentage of Participants With Cmax >2500 ng/dL|Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
2775660|NCT00702650|Secondary|Percentage of Participants With Cmax Between 1800 and 2500 ng/dL|Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
2775661|NCT00702650|Secondary|Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL|Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
2775662|NCT00702650|Primary|Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120|Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures).|||percentage of participants||95% Confidence Interval|Number
2775663|NCT00702624|Primary|Number of Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Live born infants|||Number
2775664|NCT00702624|Primary|Number of Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Live born infants|||Number
2775665|NCT00702624|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Participants|||Number
2775666|NCT00702624|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Participants|||Number
2775667|NCT00702624|Primary|Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.|||Percentage of participants|||Number
2775668|NCT00702546|Secondary|Percentage of Participants With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
2775669|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
2775670|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
2775671|NCT00702546|Secondary|Percentage of Participants in Follow up Study With an Ecotopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
2775672|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711 with vital pregnancy|||Percentage of participants|||Number
2775673|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants in follow up study P05711 with a clinical pregnancy|||Percentage of participants|||Number
2775674|NCT00702546|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.|Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.|||Percentage of participants|||Number
2775675|NCT00702520|Primary|Take-Home Baby Rate|The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).|Birth of a one or more live babies (Up to 1 year)|Participants treated with Corifollitropin alpha in the base study (P05788, 38833).|||Percentage of participants|||Number
2775676|NCT00702520|Primary|Number of Infants Experiencing SAEs|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
2775677|NCT00702520|Primary|Number of Infants Experiencing AEs|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
2775678|NCT00702520|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
2775679|NCT00702520|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
2775680|NCT00702507|Secondary|Number of Participants With Mycological Cure of First to Third Recurrent Episodes|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
2775681|NCT00702507|Secondary|Number of Participants With Clinical Cure of First to Third Recurrent Episodes|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clinical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
2776019|NCT00700375|Primary|Occurrence of Contrast-induced Nephropathy|The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.|after procedure and 1,2-3day after procedure||||participants|||Number
2775682|NCT00702507|Secondary|Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as Successes; those without OC were categorized as Failures (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication."|Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
2775683|NCT00702507|Secondary|Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.|||scores on a scale||Full Range|Median
2775684|NCT00702507|Secondary|Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.|||scores on a scale||Full Range|Median
2775685|NCT00702507|Secondary|Number of Participants With Mycological Cure|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population|||participants|||Number
2775686|NCT00702507|Secondary|Number of Participants With Clinical Cure|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clianical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population|||participants|||Number
2775687|NCT00702507|Primary|Number of Participants With Overall Cure (OC)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as Successes; those without OC were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species)|||participants|||Number
2775688|NCT00702468|Secondary|Carer Global Impressions of Change for Ease of Transfer|"The main carer will be asked to assess the change in the subject's condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject's general functional abilities changed? How has the subject's ease of transfer? Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35||||paticipants|||Number
2775689|NCT00702468|Secondary|Carer Global Impressions of Change for Functional Ability|"The main carer will be asked to assess the change in the subject's condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject's general functional abilities changed? How has the subject's ease of transfer? Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35||||paticipants|||Number
2775690|NCT00702468|Secondary|Subject Global Impressions of Change.|"At baseline subjects will write a brief description of their spasticity caused by MS and how it affects them emotionally, physically and their ability to function with day to day activities. This will be used to aid their memory before they answer the following question which is rated on a seven-point scale.~Please assess the change in your spasticity due to MS since immediately before receiving the first course of study treatment (Baseline) using the scale below The markers are: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better."|Day 35||||participants|||Number
2775691|NCT00702468|Secondary|Daily Sleep Disruption NRS|"Subjects will be asked: On a scale of 0-10 please indicate how your spasticity disrupted your sleep last night with the anchors 0 = 'did not disrupt sleep', 10 = 'completely disrupted (unable to sleep at all)'."|Week 1- Week 5|It is important to note that 16 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.|||points on scale||Standard Deviation|Mean
2776049|NCT00700102|Secondary|Progression Free Survival: Time to Event||within 6.5 years|Unstratified intention to treat population|||Months||Full Range|Median
2776050|NCT00700102|Secondary|Participants With Progression Free Survival Event||within 6.5 years|Unstratified intention to treat population|||participants|||Number
2775692|NCT00702468|Secondary|Timed 10-metre Walk.|The time taken to travel 10 metres.|Week 2 and Week 5|ITT. Only 4 placebo subjects were included in the analysis and 11 of the Sativex subjects. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||Seconds||Standard Deviation|Mean
2775693|NCT00702468|Secondary|Change in Motricity Index|The Motricity Index involves assessing three movements in both the arms and the legs. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement.|Week 2 and Week 5|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||points on scale||Standard Deviation|Mean
2775694|NCT00702468|Secondary|Change in Modified Ashworth Scale.|"The Modified Ashworth Scale was completed at baseline and at the end of treatment at approximately the same time of day. All 20 muscle groups were assessed for spasticity (using a 0=no increase in muscle tone to 4 scale=affected part rigid in flexion or extensions), to result in a total score out of 80. The higher the score the worse the spasticity is.~The change from baseline to end of study was assessed. The higher the score the better"|Day 7 to Day 28|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||score on scale||Standard Deviation|Mean
2775695|NCT00702468|Secondary|Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).|"Spasticity NRS was completed daily by answering the following question:~On a scale of '0 to 10' please indicate the average level of your spasticity over the last 24 hours with the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'. The change in mean spasticity severity NRS from baseline to end of study (last seven days)was calculated. A negative change from baseline indicates an improvement in spasticity."|Baseline (Week 1) to Week 5|It is important to note that 17 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.|||points on scale||Standard Deviation|Mean
2775696|NCT00702468|Primary|Number of Subjects Who Experience Treatment Failure.|The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the treatment baseline; the day of a clinically relevant increase in anti-spasticity or disease modifying medication. The number of subjects who failed treatment were calculated.|Week 1- Week 5||||Participants|||Number
2775697|NCT00702403|Secondary|Relapse|The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia|1 and 3 years|Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.|||Participants|||Count of Participants
2775698|NCT00702403|Secondary|Patients Alive With Out Relapse|The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year|Up to 1 year|Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data|||Participants|||Count of Participants
2775699|NCT00702403|Secondary|Survival|The proportion of study participants alive at 1, 2 and 3 years|Up to 3 years|Overall Survival (complete follow-up is available out to three years for all patients)|||Participants|||Count of Participants
2775700|NCT00702403|Secondary|The Proportion of Patients at 1 Year With Treatment Efficacy Success|To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, >5% BCR/ABL in marrow by fluorescent in situ hybridization, or >1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).|Up to 1 year|"The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by intention to treat), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality."|||Participants|||Count of Participants
2775701|NCT00702403|Primary|Number of Participants With Treatment Safety Failure|Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.|Up to 365 days post-transplant|"Critical to note are two intention-to-treat populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib."|||Participants|||Count of Participants
2775702|NCT00702377|Primary|Corneal Staining|Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42||||Units on a scale||Standard Deviation|Mean
2775783|NCT00701805|Secondary|The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%||Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||Percentage of Participants|||Number
2775703|NCT00702377|Primary|Conjunctival Staining|Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42||||Units on a scale||Standard Deviation|Mean
2775704|NCT00702377|Primary|Tear Break-up Time|Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.|Day 0, Day 7, Day 14, Day 28, and Day 42||||seconds||Standard Deviation|Mean
2775705|NCT00702364|Secondary|Neurobehavioral Functioning Inventory Depression Subscale|"Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring never, rarely, sometimes, often, or always. Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology."|Post treatment||||T-score||95% Confidence Interval|Mean
2775706|NCT00702364|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score|"The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms (never, rarely, sometimes, often, and very often). A previous study of the ASRS found the self-report to be both valid (Cronbach's alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score."|Post treatment||||units on a scale||95% Confidence Interval|Mean
2775707|NCT00702364|Primary|Stroop Test Interference T-score|The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.|Post treatment||||T-score||95% Confidence Interval|Mean
2775708|NCT00702364|Primary|CDR Power of Attention|"Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.~Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,"|Post treatment||||msec||95% Confidence Interval|Mean
2775709|NCT00702338|Primary|Number of Infants With SAEs During Follow-up|An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.|||participants|||Number
2775710|NCT00702338|Primary|Number of Infants With AEs During Follow-up|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.|||participant|||Number
2775711|NCT00702338|Primary|Number of Mothers With Serious AEs (SAEs) During Follow-up|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.|||participants|||Number
2775724|NCT00702325|Secondary|Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period|Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
2775801|NCT00701727|Secondary|de Novo Cholesterol Synthesis (DNC)|Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.|7 weeks|per protocol, all subjects|||%/day plasma DNC||Standard Deviation|Mean
2775712|NCT00702338|Primary|Number of Mothers With Adverse Events (AEs) During Follow-up|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.|||participants|||Number
2775713|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis|Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Participants in the Intent-to-Treat group (ITT) in base study P05693 (NCT00697255) that received bolus injection of hCG.|||percentage of participants|||Number
2775714|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Intent-to-Treat group (ITT) consisted of all treated participants in base study P05693 (NCT00697255): 5 participants in Stage Ia and 3 participants in Stage Ib.|||percentage of participants|||Number
2775715|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|1 week||||Participants|||Number
2775716|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away|1 week||||Participants|||Number
2775717|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|12 week||||Participants|||Number
2775718|NCT00702325|Secondary|Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)|There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
2775719|NCT00702325|Secondary|Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment|There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.|12 weeks||||Proportion of Participants|||Number
2775720|NCT00702325|Secondary|Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])|Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2775721|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away|12 week||||Participants|||Number
2775722|NCT00702325|Secondary|Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period|Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
2775723|NCT00702325|Secondary|Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period|Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
2775725|NCT00702325|Secondary|Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period|Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
2775726|NCT00702325|Secondary|Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
2775727|NCT00702325|Secondary|Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
2775728|NCT00702325|Secondary|Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period|Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Number of nights||Standard Deviation|Mean
2775729|NCT00702325|Secondary|Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2775730|NCT00702325|Secondary|Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2775731|NCT00702325|Secondary|Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2775732|NCT00702325|Secondary|Number of Withdrawals Due to a Predefined Asthma Event|Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)|12 weeks||||Participants|||Number
2775733|NCT00702325|Secondary|Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry|Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)|12 weeks||||Participants|||Number
2775734|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period|Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/second||Standard Deviation|Mean
2775735|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2775736|NCT00702325|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
2775802|NCT00701727|Secondary|Change From Baseline in Total Cholesterol, From Fasting Plasma Samples|plasma levels of total cholesterol|7 weeks|per protocol, all subjects|||mg/dL total cholesterol||Standard Deviation|Mean
2775737|NCT00702325|Secondary|Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
2775738|NCT00702325|Primary|Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2775739|NCT00702299|Secondary|Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed|Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration|18 months||||ug/mL||Standard Deviation|Mean
2775740|NCT00702299|Secondary|Overall Survival||Average Length of follow-up 788 days||||Days||Full Range|Median
2775741|NCT00702299|Secondary|Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125|Progression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria|18 months||||% of participants|||Number
2775742|NCT00702299|Primary|Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)|Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0|18 months||||participants|||Number
2775743|NCT00702299|Primary|Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level.|18 months||||% of participants|||Number
2775744|NCT00702299|Primary|Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.|18 months||||mg/m2|||Number
2775745|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
2775746|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
2775747|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
2775748|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ectopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study.|||Percentage of participants|||Number
2775749|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a vital pregnancy.|||Percentage of participants|||Number
2775750|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a clinical pregnancy.|||Percentage of participants|||Number
2775751|NCT00702273|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.|Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial|ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH.|||Percentage of participants|||Number
2776051|NCT00700102|Secondary|Overall Survival: Months From Time of First Line Therapy||within approximately 9.6 years||||months||95% Confidence Interval|Median
2775752|NCT00702234|Primary|Number of Live Born Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
2775753|NCT00702234|Primary|Number of Live Born Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
2775754|NCT00702234|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
2775755|NCT00702234|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
2775756|NCT00702234|Primary|Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)|The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.|Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)|Participants administered corifollitropin alfa in base study P05714 (NCT00696878)|||percentage of participants|||Number
2775757|NCT00702221|Primary|Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)||baseline to 8 weeks|study prematurely terminated|||mmHg||Standard Error|Mean
2775758|NCT00702208|Primary|Kappa Coefficient|Kappa comparing clinician-collected cytology result to self-lavage cytology result|1-3 months between 2 specimen collections||||kappa coefficient for paired specimens||95% Confidence Interval|Number
2775759|NCT00702208|Secondary|Outcome: Acceptability of Device|On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening|cross-sectional - asked at time of Screener use|For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).|||units on a scale||Inter-Quartile Range|Median
2775760|NCT00702208|Primary|Sensitivity and Specificity|"We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.~The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints."|1-3 months between 2 specimen collections||||% of participants correctly diagnosed||95% Confidence Interval|Number
2775761|NCT00702143|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||SUVR||Standard Deviation|Mean
2775762|NCT00702143|Secondary|Proportion of Positive Florbetapir-PET Scans|Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||percentage of amyoid positive scans|||Number
2775763|NCT00702143|Primary|Qualitative Amyloid Image Assessment|Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||participants|||Number
2775781|NCT00701805|Secondary|Duration of 2 Consecutive Decreases in iPTH >= 50%||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||days||Standard Deviation|Mean
2775764|NCT00701935|Secondary|Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event|All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||hypoglycemia rate/year||Standard Error|Mean
2775765|NCT00701935|Secondary|Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months|Change in HDL cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
2775766|NCT00701935|Secondary|Change in Triglycerides From Baseline to 6 Months|Change in triglycerides|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
2775767|NCT00701935|Secondary|Change in Total Cholesterol From Baseline to 6 Months|Change in total cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
2775768|NCT00701935|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Change in Diastolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2775769|NCT00701935|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months|Change in Systolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2775770|NCT00701935|Secondary|Change in Weight From Baseline to 6 Months|Change in weight|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.|||kg||Standard Error|Least Squares Mean
2775771|NCT00701935|Secondary|Change in Fasting Plasma Glucose From Baseline to 6 Months|Change in Fasting plasma glucose|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.|||mmol/L||Standard Error|Least Squares Mean
2775772|NCT00701935|Secondary|Percentage of Patients With HbA1c <=7.0% at 6 Months|Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.|||Percentage of patients|||Number
2775773|NCT00701935|Secondary|Change in HbA1c From Baseline to 6 Months|Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.|||% change||Standard Error|Least Squares Mean
2775774|NCT00701935|Secondary|Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months|Percentage change in subcutaneous abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
2775775|NCT00701935|Secondary|Percentage Change in Total Abdominal Fat From Baseline to 6 Months|Percentage change in total abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
2775776|NCT00701935|Primary|Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months|Percentage change in abdominal visceral fat|baseline, 6 months|Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
2775777|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.|||Percentage of participants|||Number
2775778|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.|||Percentage of participants|||Number
2775779|NCT00701805|Other Pre-specified|The Percentage of Participants With Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)|Anytime from Week 13 through Week 53||||Percentage of participants|||Number
2775780|NCT00701805|Secondary|Duration of 2 Consecutive iPTH Values <= 180 pg/mL||From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||days||Standard Deviation|Mean
2775784|NCT00701805|Secondary|The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||Percentage of participants|||Number
2775785|NCT00701805|Secondary|The Mean Change in Intact Parathyroid Hormone (iPTH)||From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||picograms/milliliter (pg/mL)||95% Confidence Interval|Mean
2775786|NCT00701805|Primary|The Percentage of Participants With Hyperphosphatemia|The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.|||Percentage of participants|||Number
2775787|NCT00701805|Primary|The Percentage of Participants With of Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.|||Percentage of participants|||Number
2775788|NCT00701779|Secondary|Number of Participants With a Reduction of AUR and BPH-related Surgery|To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.|13 months||||Participants|||Count of Participants
2775789|NCT00701779|Secondary|Economic Impact|Annual financial cost per participant starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.|13 months||||US dollars||Standard Deviation|Mean
2775790|NCT00701779|Secondary|Safety and Tolerability|To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.|13 months||||adverse events|||Number
2775791|NCT00701779|Secondary|Health Outcome Measures|Number of participants who are able to subsequently reduce or discontinue Tamsulosin usage after starting with combination therapy with Dutasteride and Tamsulosin while still maintaining the same degree of improvement in lower urinary tract symptoms|13 months||||Participants|||Count of Participants
2775792|NCT00701779|Primary|Prostate Specific Antigen|Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||ng/mL||Standard Deviation|Mean
2775793|NCT00701779|Primary|Post-void Residual Volume|Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||mL||Standard Deviation|Mean
2775794|NCT00701779|Primary|Benign Prostate Hyperplasia Impact Index|"Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Benign Prostatic Hyperplasia Impact Index asked the following:~Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)~Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)~Overall, how bothersome has any trouble with urination been during the past month? (0-3)~Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13."|12 months||||units on a scale||Standard Deviation|Mean
2775795|NCT00701779|Primary|Peak Flow Rate (QMax)|Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||ml/sec||Standard Deviation|Mean
2775796|NCT00701779|Primary|International Prostate Symptom Score|"Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.~Total range is from 0-35. The scores are evaluated as such:~0-7: Mild 8-19: Moderate 20-35: Severe"|12 months||||units on a scale||Standard Deviation|Mean
2775797|NCT00701727|Secondary|High-density Lipoprotein (HDL)|Change from baseline in plasma HDL, measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL HDL||Standard Deviation|Mean
2775798|NCT00701727|Secondary|Low-density Lipoprotein (LDL);|Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL LDL||Standard Deviation|Mean
2775799|NCT00701727|Secondary|Triglycerides (TG)|Change from baseline in plasma triglycerides, measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL TG||Standard Deviation|Mean
2775800|NCT00701727|Secondary|Cholesterol Efflux Rate (Ra Cholesterol)|The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm - 12 noon). This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.|7 weeks|per protocol, all subjects|||mg/kg/hr cholesterol||Standard Deviation|Mean
2776052|NCT00700102|Primary|Overall Survival: Time From Randomization to Death From Any Cause||within 6.5 years|Intention to treat|||months||95% Confidence Interval|Median
2775803|NCT00701727|Primary|Fecal Excretion of Plasma-derived Cholesterol|"(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:~The composition of fecal neutral and acidic sterols will be measured as % of total.~The excretion rate of fecal neutral and acidic sterols will be measured as mg/day.~The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE).~Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated as %/day."|7 weeks|Per Protocol,all subjects|||mg/day cholesterol excreted||Standard Deviation|Mean
2775804|NCT00701714|Secondary|Immunogenicity|Number of participants with antibody formation against Epoetin during treatment period (safety set)|13 weeks||||participants|||Number
2775805|NCT00701714|Primary|Weekly Epoetin Dose|Mean weekly epoetin dose [IU/kg] in study weeks 11-13|weeks 11-13|Full analysis set required: “all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available”. 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.|||IU/kg||Standard Deviation|Mean
2775806|NCT00701714|Primary|Change in Hemoglobin Level|Mean absolute change in hemoglobin (baseline to end of study week 13)|13 weeks|Full analysis set required: “all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available”. 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.|||g/dL||Standard Deviation|Mean
2775807|NCT00701675|Primary|Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg|Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.|11 weeks from baseline|sertraline 50mg group and placebo group each had 2 subjects with missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2775808|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Baseline to Week 25|The SDS comprised all treated patients.|||participants|||Number
2775809|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.|Baseline to Week 25|The SDS comprised all treated patients.|||participants|||Number
2775810|NCT00701662|Secondary|Number of Patients With Local/Injection Site Reactions|All AEs arising from local/injection site reactions.|For the duration of the study, up to Week 25|The SDS comprised all treated patients.|||participants|||Number
2775811|NCT00701662|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The SDS comprised all treated patients.|||AEs per infusion|Participants||Number
2775812|NCT00701662|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The safety data set (SDS) comprised all treated patients.|||participants|||Number
2775813|NCT00701662|Secondary|Overall Health Status at Baseline and Week 25|Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.|Baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
2775814|NCT00701662|Secondary|Treatment Satisfaction at Baseline and Week 25|Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
2775815|NCT00701662|Secondary|Health-Related Quality of Life at Baseline and Week 25|"Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad).~Note: No patients received IgG treatment at the hospital/doctor's office at Week 25."|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
2775816|NCT00701662|Secondary|Mean Motor Function Score at Screening and Week 25|For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).|Screening and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||Full Range|Mean
2775836|NCT00701363|Secondary|Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL||At weeks 24 and 48|n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
2775817|NCT00701662|Primary|Mean Overall MRC Score at Baseline and Week 24|The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.|Baseline and week 24|The ITT data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.|||score on a scale||Full Range|Mean
2775818|NCT00701662|Secondary|Change From Baseline to the Completion Visit in Motor Function|"The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method.~For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to the completion visit (up to week 25)|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||95% Confidence Interval|Mean
2775819|NCT00701662|Secondary|Mean Disability Score at Baseline and Week 24|Disability was measured using a modified Guy's Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.|Baseline and Week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||Full Range|Mean
2775820|NCT00701662|Secondary|Change From Baseline to Week 24 in Disability|"The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~Disability was measured using a modified Guy's Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||95% Confidence Interval|Mean
2775821|NCT00701662|Primary|Change From Baseline to Week 24 in Muscle Strength|"The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Baseline to week 24|The Intention-to-Treat (ITT) data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.|||score on a scale||95% Confidence Interval|Mean
2775822|NCT00701636|Primary|Mean Daptomycin Concentrations at 12, 18, 24, and 48 h|Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h|Hospital discharge or 7 days, whichever comes first|Based on sample sizes from previously published studies on antibiotic pk for CABG surgery.|||mcg/ml||Standard Deviation|Mean
2775823|NCT00701558|Secondary|Overall Survival|Overall survival was defined as the interval between the day of randomization and the date of death from any cause.|From the time of randomization until death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.|||weeks||95% Confidence Interval|Median
2775824|NCT00701558|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the time of randomization until disease progression or death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.|||percentage of participants|||Number
2775825|NCT00701558|Primary|Time to Disease Progression|Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|From the time of randomization until disease progression or death (up to 193 weeks)]|Intention to treat (ITT) population included all participants who were randomized to treatment group.|||weeks||95% Confidence Interval|Median
2775826|NCT00701441|Other Pre-specified|Peroxynitrite Deposition in the Vascular Walls|A forearm biopsy will be collected to isolate human microcirculatory endothelial cells. The stain density of peroxynitrite, an indicator of oxidative stress, in the vascular walls is compared between pre-treatment and post treatment patient tissue. Also another comparison is made between pre-treatment and control tissue. The stain density is a software-generated measurement of pixel intensity and is considered to be an arbitrary unit. Higher numbers indicate greater density|baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and flow mediated dilation only.|||stain density units||Standard Error|Mean
2775827|NCT00701441|Primary|Flow Mediated Dilation|A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.|Baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and nitrotyrosine stain density values only.|||percentage change of vessel diamter||Standard Error|Mean
2775828|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Urine|Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Number of participants analyzed=participants with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.|||Percent change||Standard Deviation|Mean
2775829|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Plasma|Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.|||Percent change||Standard Deviation|Mean
2775830|NCT00701415|Primary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.|Baseline, Week 52, Week 156 and Week 260|Analysis was performed on Full analysis set (FAS), which included all randomized participants who received at least 1 infusion of study treatment.|||Percentage of participants|||Number
2775831|NCT00701389|Secondary|Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The number of participants who were discontinued from the study due to adverse event was summarized.|up to 10 weeks|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Participants|||Number
2775832|NCT00701389|Secondary|Number of Participants Who Experienced an Adverse Event During the Study|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 10 weeks)|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Participants|||Number
2775833|NCT00701389|Secondary|Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.|||mmHg||95% Confidence Interval|Least Squares Mean
2775834|NCT00701389|Primary|Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.|||mmHg||95% Confidence Interval|Least Squares Mean
2775835|NCT00701363|Secondary|Subject Treatment Schedule Preference|"At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.~At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Lan: Lanreotide~W: Week~Inj: Injection~Wks: Weeks~Phs: Phase~Grp: Group~evy: every"|||Percentage of subjects|||Number
2775838|NCT00701363|Secondary|Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit|"AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.~IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.~Correlation presented is a Spearman correlation (non parametric)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."|||Correlation coefficient||95% Confidence Interval|Number
2775839|NCT00701363|Secondary|Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48|The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.|At week 48 (End of Study)|"MITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."|||Percentage of subjects||95% Confidence Interval|Number
2775840|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (SF-36)|Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.|||Units on a scale||Standard Deviation|Mean
2775841|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (AcroQoL)|AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|"ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 & did not move onto phase 2.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included"|||Units on a scale||Standard Deviation|Mean
2775842|NCT00701363|Secondary|Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)|Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).|At baseline, week 24 and week 48|"ITT population.~Number of Participants Analyzed:~Phase 1 in week 24: 3~Phase 2 (Group A) in week 24: 13~Phase 2 (Group B) in week 24: 69~Phase 2 (Group C) in week 24: 25~Phase 2 (Group A) in week 48: 13~Phase 2 (Group B) in week 48: 68~Phase 2 (Group C) in week 48: 26~NA = Not Applicable"|||Units on a scale||Standard Deviation|Mean
2775843|NCT00701363|Secondary|Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24||Baseline (visit 1)|"ITT population. n = Number of subjects at the visit.~These subjects entered in phase 2~One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline."|||Percentage of ULN||95% Confidence Interval|Mean
2775844|NCT00701363|Secondary|Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C||Baseline (visit 1)|"MITT population.~One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48."|||Percentage of ULN||95% Confidence Interval|Mean
2775845|NCT00701363|Secondary|Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval|IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline|Baseline (visit 1) and week 48|MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.|||Percentage of ULN||Standard Deviation|Mean
2775846|NCT00701363|Secondary|Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels|The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.|At week 48|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
2775847|NCT00701363|Secondary|Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks|The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.|During phase 2 of the study (up to week 48)|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
2775848|NCT00701363|Secondary|Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)|The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.|At week 24|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
2775849|NCT00701363|Primary|Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)|A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)|At week 48 (End of Study)|"Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).~n = Number of subjects at the visit"|||Percentage of subjects||95% Confidence Interval|Number
2776053|NCT00700063|Primary|Complete Clearance Rate of AK Lesions;|Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area|Day 57||||participants|||Number
2775850|NCT00701311|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks||||participants|||Number
2775851|NCT00701129|Primary|Disability Index Assessed by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at End of Study|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. It consists of all items of the original PEDI (197 functional skill items in 3 domains: self-care; mobility; and social function) and additional items in the functional skills, mobility, and self-care domains to reflect clinically relevant functional skills for children with Pompe disease. Each domain consisted of 2 subdomains: functional skill performance and caregiver assistance scale. Norm-based scoring was developed for these additional items, and scoring algorithms for the PEDI have been adjusted to reflect additional normative data collected for the Pompe PEDI. Total score range for each domain (mean of subdomains) and subdomain ranges from 0 to 100, where higher score indicates high capability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patient analyzed = number of patients with end of study Pompe PEDI assessment and n = number of patients with end of study assessment of specified category.|||units on a scale||Full Range|Median
2775852|NCT00701129|Primary|Motor Development Status Assessed by Alberta Infantile Motor Scale (AIMS) at End of Study|"AIMS is a 58-item reliable and valid measure of motor development for infants at risk for motor delay. It assesses infant movement in 4 positions (subscales): prone (reciprocal crawling); supine (moving hands to feet); sitting (sitting with arm support); and standing (pulls to stand). For each subscale, items were scored as observed or not observed. Item in the observed range create a motor window. When scoring, subscale scores are calculated by giving the child credit (1 point) for observed items within the motor window in addition to being given credit (1 point) for all of the less mature items before motor window. AIMS total score was calculated by summing the scores for 58 items and ranged from 0 to 58, with higher score indicating more mature motor development. Score was then compared with age-equivalent peers from normative sample and equivalence level age (in months) is reported. End of study refers to the last post baseline observation during study period (up to Week 79)."|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study AIMS assessment.|||months||Full Range|Median
2775853|NCT00701129|Primary|Gross Motor Disability Assessed by Gross Motor Function Measure-88 (GMFM-88) at End of Study|GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item is scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension is expressed as a percentage of the maximum score for that dimension. Total score is obtained by adding the percentage scores for each dimension and dividing the sum by the total number of dimensions. Total score ranges from 0% to 100%, where higher scores indicate better motor functions. A total score of <7.5% demonstrates gross motor disability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study GMFM-88 assessment.|||percentage of maximum total score||Full Range|Median
2775854|NCT00701129|Primary|Number of Patients With Ventilator Use at End of Study|Number of patients who had ventilator support at end of study was reported. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
2775855|NCT00701129|Primary|Number of Patients With Normal/Abnormal Left Ventricular Mass (LVM) Z-Score and LVM Index at End of Study|LVM Z-score and LVM index were assessed by ECHO. LVM Z-Score provides an indicator of degree of standard deviations from the mean in a normal distribution. Negative values indicate a smaller LVM than mean and values higher than 0 indicate a larger LVM than the mean. The normal range for LVM Z-Score is -2 to 2. Values <-2 or >2 indicate abnormal LVM Z-Score. LVM index is an index value derived by normalizing LVM by body surface area. LVM index provides evidence of cardiomyopathy. LVM index values <65 gram per meter^2 (g/m^2) were considered as normal and LVM index values >=65 g/m^2 were considered as abnormal. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
2775856|NCT00701129|Primary|Number of Patients Who Survived at End of Study||Baseline up to End of study (Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
2775857|NCT00701129|Primary|Number of Patients With Recombinant Human Acid Alfa-glucosidase (rhGAA) Inhibitory Antibody at End of Study|Patients with positive anti-rhGAA IgG antibody were assessed for the presence of inhibitory antibodies (inhibition of enzyme activity and inhibition of enzyme uptake). Enzyme-linked immunosorbent assay (ELISA) was used to measure inhibition of rhGAA enzymatic activity in vitro and a cell-based assay was used to measure the inhibition of the uptake of rhGAA in normal fibroblast cells by flow cytometry.|End of study (up to Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patients analyzed = patients with positive anti-rhGAA IgG antibody.|||participants|||Number
2775883|NCT00701051|Primary|Glucose Utilization (Pre/Post Intervention)|Insulin-stimulated glucose uptake|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
2775858|NCT00701129|Primary|Change From Baseline in Number of Patients With Anti-Recombinant Human Acid Alfa-glucosidase (Anti-rhGAA) Immunoglobulin G (IgG) Antibody at End of Study|Serum samples from patients were analyzed for the presence of anti-rhGAA IgG antibodies. End of study (EOS) refers to the last post baseline observation during study period (up to Week 79).|Baseline, End of Study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
2775859|NCT00701103|Secondary|Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)|Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND <5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.|Up to 2 years|The population consisted of all evaluable participants who received >90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.|||Percentage of Participants|||Number
2775860|NCT00701103|Secondary|Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab|It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).|Up to 2 years|The population consisted of all participants who received >90% of intended drug volume and had measurements at Baseline and at least once during treatment.|||Percentage of Participants|||Number
2775861|NCT00701103|Secondary|Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples|IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.|||H-score||Standard Deviation|Mean
2775862|NCT00701103|Secondary|Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples|IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.|||H-score||Standard Deviation|Mean
2775863|NCT00701103|Primary|Mean Trough Serum Concentration (Ctrough) of Dalotuzumab|The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.|Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.|||ug/mL||Standard Deviation|Mean
2775864|NCT00701103|Primary|Mean Serum Clearance of Dalotuzumab|Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.|||mL/min/kg||Standard Deviation|Mean
2775865|NCT00701103|Primary|Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab|AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.|||mg*hr/mL||Standard Deviation|Mean
2775884|NCT00701051|Secondary|Baseline 2-hour Postprandial Glucose||baseline||||mg/dl||Standard Error|Mean
2775885|NCT00701051|Primary|Baseline Glucose Utilization|Insulin-stimulated glucose uptake|baseline||||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
2775866|NCT00701103|Primary|Mean Terminal Half-life (t1/2) of Dalotuzumab|Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.|||Hours||Full Range|Mean
2775867|NCT00701103|Primary|Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.|Up to 3 weeks|The population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2775868|NCT00701090|Secondary|Percent of Patients With A1C <6.5% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percentage of Participants|||Number
2775869|NCT00701090|Secondary|Percent of Patients With A1C <7.0% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percentage of Participants|||Number
2775870|NCT00701090|Secondary|Change From Baseline in Body Weight at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30.|||Kilograms||95% Confidence Interval|Least Squares Mean
2775871|NCT00701090|Secondary|Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30||Week 0 to Week 30|All patients who took at least one dose of study therapy.|||Percentage of Participants|||Number
2775872|NCT00701090|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||mg/dL||95% Confidence Interval|Least Squares Mean
2775873|NCT00701090|Primary|Change From Baseline in HbA1c at Week 30|Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percent||95% Confidence Interval|Least Squares Mean
2775874|NCT00701064|Secondary|Posttraumatic Stress Disorder Checklist (PCL-M)|Self-rated PTSD scale with 17 items (rated 1-5) with range of 17-85. Higher score = worse severity of PTSD. Reported are decreases from baseline to end-of-study.|Baseline to following 4-week treatment||||decrease in units on scale||Standard Error|Mean
2775875|NCT00701064|Primary|Clinical Global Impressions Scale (CGI)|The CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse|Baseline severity to post-treatment (4 weeks later) Change||||units on scale||Standard Error|Mean
2775876|NCT00701064|Primary|Clinical Assessed PTSD Scale (CAPS-2)|The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.|Mean change from baseline to post-treatment (5-6 weeks later)|Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data|||change in units on scale||Standard Deviation|Mean
2775877|NCT00701051|Secondary|Body Composition (%Fat)||baseline, 24 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||percentage of fat||Standard Error|Mean
2775878|NCT00701051|Secondary|Cardiorespiratory Fitness|Maximal oxygen consumption|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||L/Min||Standard Error|Mean
2775879|NCT00701051|Primary|Skeletal Muscle Capillarization (Pre/Post Intervention)||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||capillaries/mm2||Standard Error|Mean
2775880|NCT00701051|Primary|Baseline Skeletal Muscle Capillarization||baseline||||capillaries/mm2||Standard Error|Mean
2775881|NCT00701051|Secondary|Baseline Cardiorespiratory Fitness|maximal oxygen consumption|baseline||||L/min||Standard Error|Mean
2775882|NCT00701051|Secondary|2-hr Post-prandial Plasma Glucose Level||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||mg/dL||Standard Error|Mean
2776272|NCT00698646|Secondary|Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Weeks 4, 8, 12 and 16|Intent to treat (ITT), Last observation carried forward|||mm Hg||Standard Deviation|Mean
2775886|NCT00701038|Primary|Left Ventricular Ejection Fraction Improvement|Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.|baseline and again after three nights in hospital|ITT|||percent change||Standard Error|Mean
2775887|NCT00700999|Primary|Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.|Baseline and 12 weeks|The number of participants analyzed is only 17 in each arm. The total number of participants in the Intervention group who completed fMRI scans pre-treatment and post treatment is only 19, in the Combat Exposed Control Group it is 18. Three of the participants scans were removed from data analysis due to the level of movement during the scan.|||percent change in BOLD signal||Standard Deviation|Mean
2775888|NCT00700973|Primary|Addiction Severity Index Legal Composite|Scores range from 0 to 1, with higher scores indicating more severe legal problems.|One year post-intervention||||units on a scale||Standard Deviation|Mean
2775889|NCT00700882|Secondary|To Evaluate the PDGFR Expression, and Activation of Src Family Kinases in Tumor Samples and Correlate These Parameters With Response to Treatment.||Every 6 weeks; up to 5 years||2020-03-31|03/2020||||
2775890|NCT00700882|Secondary|Progression-free Survival|Progression-free survival is defined as the time from registration to development of progressive disease. Patients without documented progressive disease are censored at the date of last disease assessment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).|Every 6 weeks; up to 5 years||2020-03-31|03/2020||||
2775891|NCT00700882|Secondary|Duration of Response for Dasatinib Monotherapy in This Patient Population|Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).|Every 6 weeks; up to 5 years||2020-03-31|03/2020||||
2775892|NCT00700882|Primary|Objective Response Rate Among KIT-positive Patients|Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Every 6 weeks; up to 5 years|eligible and treated KIT-positive patients|||proportion of participants||90% Confidence Interval|Number
2775893|NCT00700817|Secondary|Hypoglycaamic Episodes, Weeks 52-78|Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 52-78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||episodes|||Number
2775894|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
2775895|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
2775896|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
2775897|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
2775898|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
2775899|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
2775900|NCT00700817|Secondary|Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 52, Week 78|Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Deviation|Mean
2775901|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 52|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Error|Least Squares Mean
2775902|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 26|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Error|Least Squares Mean
2775903|NCT00700817|Secondary|Mean Change in Pulse From Week 52 to Week 78|Mean change in pulse from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||beats/minute||Standard Deviation|Mean
2775904|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 52|Calculated as an estimate of the mean change from baseline in pulse at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
2775905|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 26|Calculated as an estimate of the mean change from baseline in pulse at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||beats/minute||Standard Error|Least Squares Mean
2775906|NCT00700817|Secondary|Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78|Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmHg||Standard Deviation|Mean
2775907|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
2775908|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
2775909|NCT00700817|Secondary|Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78|Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmHg||Standard Deviation|Mean
2775910|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52|Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
2775911|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26|Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
2775912|NCT00700817|Secondary|Mean Change in Waist Circumference From Week 52 to Week 78|Mean change in Waist Circumference from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||kg||Standard Deviation|Mean
2775913|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 52|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||participants||Standard Error|Least Squares Mean
2775914|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 26.|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm||Standard Error|Least Squares Mean
2776273|NCT00698646|Primary|Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward|||mm Hg||Standard Deviation|Mean
2775915|NCT00700817|Secondary|Mean Change in Waist to Hip Ratio From Week 52 to Week 78|Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||cm/cm||Standard Deviation|Mean
2775916|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 52|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm/cm||Standard Error|Least Squares Mean
2775917|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 26.|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm/cm||Standard Error|Least Squares Mean
2775918|NCT00700817|Secondary|Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.|Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
2775919|NCT00700817|Secondary|Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pg/mL||Standard Error|Least Squares Mean
2775920|NCT00700817|Secondary|Mean Change From Baseline in Adiponectin at Week 26.|Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mcg/mL||Standard Error|Least Squares Mean
2775921|NCT00700817|Secondary|Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pmol/L||Standard Error|Least Squares Mean
2775922|NCT00700817|Secondary|Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.|Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pg/mL||Standard Error|Least Squares Mean
2775923|NCT00700817|Secondary|Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.|Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||U/L||Standard Error|Least Squares Mean
2775924|NCT00700817|Secondary|Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26|Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mg/L||Standard Error|Least Squares Mean
2775925|NCT00700817|Secondary|Mean Change in Apolipoprotein B From Week 52 to Week 78|Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775926|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 52|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||g/L||Standard Error|Least Squares Mean
2775927|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 26|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||g/L||Standard Error|Least Squares Mean
2775928|NCT00700817|Secondary|Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78|Mean change in free fatty acids (FFA) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775929|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775930|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775931|NCT00700817|Secondary|Mean Change in Triglycerides (TG) From Week 52 to Week 78|Mean change in triglycerides (TG) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775932|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 52|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775933|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 26|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775934|NCT00700817|Secondary|Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78|Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775935|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775936|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775937|NCT00700817|Secondary|Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78|Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775938|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775939|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775940|NCT00700817|Secondary|Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78|Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775941|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775942|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775943|NCT00700817|Secondary|Mean Change in Total Cholesterol From Week 52 to Week 78|Mean change in total cholesterol from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775944|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 52|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775945|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 26|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775946|NCT00700817|Secondary|Mean Change in Beta-cell Function From Week 52 to Week 78|Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage point||Standard Deviation|Mean
2775947|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 52|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
2775948|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 26|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
2775949|NCT00700817|Secondary|Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78|Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
2775950|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78|Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775951|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775952|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
2775953|NCT00700817|Secondary|Mean Change in Body Weight From Week 52 to Week 78|Mean change in body weight from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||kg||Standard Deviation|Mean
2775954|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 52|Calculated as an estimate of the mean change from baseline in body weight at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||kg||Standard Error|Least Squares Mean
2775955|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 26|Calculated as an estimate of the mean change from baseline in body weight at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||kg||Standard Error|Least Squares Mean
2775956|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage of subjects|||Number
2775957|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2775958|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2775959|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2775960|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage of subjects|||Number
2775961|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2775962|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2775963|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2775964|NCT00700817|Primary|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||Percentage point of total HbA1c||Standard Deviation|Mean
2775965|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2775966|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2775967|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2775968|NCT00700804|Primary|Calcium Absorption|Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time|17 weeks|Only participants which completed both protein diet periods were included in the statistical analysis|||percentage of Calcium absorbed||Standard Deviation|Mean
2775969|NCT00700804|Secondary|Serum Insulin-like Growth Factor 1 (IGF-1)||7 weeks||||nanomoles per liter (nmols/L)||Standard Error|Geometric Mean
2775970|NCT00700752|Primary|Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).|Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.|after 4 weeks of lens wear||||Units on a scale||Standard Error|Least Squares Mean
2775971|NCT00700739|Secondary|Device Related Adverse Events|The proportion of subjects with device related adverse events as reported throughout the duration of the study.|Intra-operatively to 24 months post-operative||||Percentage of subjects|||Number
2775972|NCT00700739|Secondary|Cervical Range of Motion Measured Radiographically at 6 Months|Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.|6 months|Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure.|||degrees||Standard Deviation|Mean
2775973|NCT00700739|Secondary|Foraminal Height Measured Radiographically at 24 Months|Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).|24 months|The study was terminated prior to 24 months therefore there are no results for this endpoint.||||||
2775974|NCT00700739|Secondary|Maintenance of Disc Height Measured Radiographically at 6 Months|Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).|6 months|Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.|||mm||Standard Deviation|Mean
2775975|NCT00700739|Secondary|Adjacent Level Degeneration Measured Radiographically at 24 Months|Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.|24 months|Study was terminated prior to 24 months therefore there are no results for this endpoint.||||||
2775976|NCT00700739|Secondary|Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months|Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.|6 months|Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.|||degrees||Standard Deviation|Mean
2775977|NCT00700739|Secondary|Work Status Assessed at 12 Months|The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome.|||Percentage of Subjects|||Number
2775978|NCT00700739|Secondary|Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months|The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||Percentage of Subjects|||Number
2775979|NCT00700739|Secondary|Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775980|NCT00700739|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775981|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775982|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775983|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775984|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775985|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2775986|NCT00700739|Primary|Overall Patient Success|Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.|12 months|Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation.|||Percentage of subjects|||Number
2775987|NCT00700713|Other Pre-specified|Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2775988|NCT00700713|Other Pre-specified|Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2775989|NCT00700713|Primary|Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2775990|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 2|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
2775991|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
2775992|NCT00700635|Secondary|Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2775993|NCT00700635|Secondary|Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
2775994|NCT00700635|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
2775995|NCT00700622|Primary|Change From Baseline in HbA1c to Week 16|Change from Baseline in glycosylated hemoglobin at Week 16|Baseline to Week 16|Intent to Treat with Available Data at Week 16|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2775996|NCT00700570|Secondary|Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was to be confirmed at a minimum of 4 weeks after the first documented response. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, as well as no new target lesions. Disease progression or PD was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Non-evaluability for tumor assessment was also documented when applicable. The percentage of participants with each level of response was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
2775997|NCT00700570|Secondary|Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was confirmed at a minimum of 4 weeks after the first documented response. The percentage of participants with confirmed CR or PR was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
2775998|NCT00700570|Secondary|Time to Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Time to disease progression was defined as the time from first dose to time of disease progression. Participants without progression were censored at the time of last tumor assessment. Time to disease progression was estimated using Kaplan-Meier analysis and expressed in months.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)|ITT Population.|||months||95% Confidence Interval|Median
2775999|NCT00700570|Secondary|Percentage of Participants With Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20 percent (%) increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])|ITT Population.|||percentage of participants|||Number
2776000|NCT00700570|Primary|Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases|Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as [number of participants eligible for surgical resection divided by the number analyzed] multiplied by 100.|After 5 cycles of neoadjuvant treatment (10 weeks)|ITT Population.|||percentage of participants|||Number
2776001|NCT00700440|Secondary|1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival||5 year|||||||
2776002|NCT00700440|Primary|3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy|"The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.~Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria."|3 months||||participants with loco-regional control|||Number
2776003|NCT00700427|Secondary|Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49|"The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state worse than dead. A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline."|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2776004|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2776005|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2776006|NCT00700427|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49|CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2776007|NCT00700427|Secondary|Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49|The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2776008|NCT00700427|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49|The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.|Baseline (Week 24), Week 49|All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2776009|NCT00700427|Secondary|Number of Days Until Relapse|"Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.~CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)."|Baseline (Week 24) up to Week 49|Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).|||days||Standard Deviation|Mean
2776010|NCT00700427|Primary|Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period|Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.|Baseline (Week 24) up to Week 49|Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).|||percentage of responders|||Number
2776011|NCT00700401|Secondary|Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48|Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.|Baseline, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.|||Percent change||Standard Error|Mean
2776012|NCT00700401|Secondary|Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48|Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.|At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.|||Percent change||Standard Error|Mean
2776013|NCT00700401|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 48 weeks|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||participants|||Number
2776014|NCT00700401|Secondary|Percentage of Participants With Positive Predictive Value|Positive predictive value is defined as participants with RVR who did not achieve SVR.|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2776015|NCT00700401|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.|At week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2776016|NCT00700401|Secondary|Percentage of Participants With Virological Response at Week 24|Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).|At Week 24|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2776017|NCT00700401|Secondary|Percentage of Participants With Rapid Virological Response at Week 4|Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.|At Week 4|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2776018|NCT00700401|Primary|Percentage of Participants With Sustained Virological Response at Week 48|Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2776324|NCT00697593|Primary|Biochemistry - C-Reactive Protein (CRP)|Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L|Week 12 / Early Termination|Safety Population - 1 participant with missing values|||participants|||Number
2776020|NCT00700310|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set|||Percent Change||Full Range|Median
2776021|NCT00700310|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set.|||Percentage of Participants|||Number
2776022|NCT00700310|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.|||Percent Change||Full Range|Median
2776023|NCT00700271|Secondary|Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for 5 minutes; the investigator then took 3 blood pressure and 1 pulse rate reading. The measurements were recorded at 1-2 minute intervals. BP Control is defined as msSBP/msDBP <149/90 mmHg and/or <130/80 mmHg if diabetes or renal insufficiency (RI).|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of participants|||Number
2776024|NCT00700271|Secondary|Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of participants|||Number
2776025|NCT00700271|Secondary|Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of Participants|||Number
2776026|NCT00700271|Secondary|Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||Percentage of Participants|||Number
2776027|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Mean
2776028|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
2776029|NCT00700271|Secondary|Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
2776030|NCT00700271|Secondary|Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
2776031|NCT00700271|Secondary|Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
2776032|NCT00700271|Secondary|Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
2776033|NCT00700271|Primary|Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.|||mmHg||Standard Error|Least Squares Mean
2776034|NCT00700180|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to death due to any cause, or to end of study|ITT Population.|||months||95% Confidence Interval|Median
2776035|NCT00700180|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause|ITT population.|||percentage of participants|||Number
2776036|NCT00700180|Secondary|Duration of Response - Time to Event|The median time, in months, from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR). Median Duration of Response was estimated using the Kaplan-Meier method.|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|ITT population: only participants with an objective tumor response (CR or PR) were included in the analysis.|||months||95% Confidence Interval|Median
2776037|NCT00700180|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response is defined as time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR).|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT population; only participants with an objective tumor response (CR or PR) were included in the analysis.|||percentage of participants|||Number
2776054|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776325|NCT00697593|Primary|Biochemistry - Urea|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||mmol/L||Standard Deviation|Mean
2776038|NCT00700180|Secondary|Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks|Percentage of participants with measurable disease at baseline who on assessment achieved CR, PR, or SD according to RECIST. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. For participants with SD, follow-up assessments must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population|||percentage of participants||95% Confidence Interval|Number
2776039|NCT00700180|Secondary|Percentage of Participants With Objective Response|Percentage of participants with CR or PR according to RECIST criteria. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses were confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population. Data for 12 participants (3 at 7.5 mg and 9 at 15 mg) were excluded for reasons including but not limited to: no study treatment (ST), no postbaseline tumor assessment (TA), non-protocol defined antineoplastic therapy before first TA, first TA >70 days after last dose of last ST, last TA less than (<) 42 days from start of therapy.|||percentage of participants||95% Confidence Interval|Number
2776040|NCT00700180|Secondary|Progression-Free Survival - Time to Event|PFS was defined as the time between randomization and disease progression or death due to any cause. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization. Disease progression was evaluated according to the RECIST using CT scans, MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method.|Baseline, Day 1, weekly to disease progression|ITT Population.|||months||95% Confidence Interval|Median
2776041|NCT00700180|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was defined as the time between randomization and progressive disease (PD) according to RECIST criteria, or death due to any cause. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. Disease progression was evaluated according to the RECIST using computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization.|Baseline, Day 1, weekly to disease progression|ITT population.|||percentage of participants|||Number
2776042|NCT00700180|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level|Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor [bFGF], E-selection, intracellular adhesion molecule [ICAM], placental growth factor [PlGF], vascular endothelial growth factor A [VEGF A], vascular endothelial growth factor receptor [VEGFR]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (≤) median baseline level, high-level=greater than (>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|Biomarker Evaluable Protein Plasma (BEP) Population: Participants in the ITT population who started at least 1 dose of bevacizumab and had a non-missing baseline biomarker level determined for at least 1 biomarker. n (number) equals (=) number of participants assessed for the specified biomarker.|||percentage of participants|||Number
2776043|NCT00700141|Secondary|Pharmacoeconomic Benefits as Assessed by the Surgeon|Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)|peri- and post-surgery until hospital discharge|"All 482 patients included and treated with TachoSil®, missing values not imputed.~Multiple answers possible."|||participants|||Number
2776044|NCT00700141|Primary|Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales|Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)|after surgery|"All 482 patients included and treated with TachoSil® [= Intention to Treat population (ITT)], missing values not imputed.~For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)"|||Units on a scale||Standard Deviation|Mean
2776045|NCT00700115|Primary|Plasma Viral Loads (HIV-1 RNA PCR)|Percentage subjects with undetectable Plasma viral loads|baseline to week 48||||percentage of subjects||95% Confidence Interval|Number
2776046|NCT00700115|Secondary|To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects||48 weeks|intention to treat|||mg/dL||Standard Error|Mean
2776047|NCT00700102|Secondary|Response Rate: Participants With Response Status Based on RECIST Criteria|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 6.5 years|Participants with measurable disease|||percentage of participants||95% Confidence Interval|Number
2776048|NCT00700102|Secondary|Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria||within 6.5 years|Participants with measurable disease|||percentage of participants||95% Confidence Interval|Number
2776055|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776056|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776057|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776058|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776059|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776060|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.~The actual value and change from baseline in the composite LSR score were also summarized."|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||units on a scale||Standard Deviation|Mean
2776061|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.~The actual value and change from baseline in the composite LSR score were also summarized."|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||scores on a scale||Standard Deviation|Mean
2776062|NCT00700063|Primary|Incidence of SAE Recorded Throughout the Study|Incidence of SAE recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776063|NCT00700063|Secondary|Efficacy (Clearance of AK Lesions) Partial Clearance Rate|Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp|57 days||||participants|||Number
2776064|NCT00700063|Primary|Incidence of AEs Recorded Throughout the Study|Incidence of AEs recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.|||participants|||Number
2776065|NCT00700011|Primary|To Determine the Non-hematologic Toxicity Profile of This Dose Schedule (Grade 2 and Above)|Assess for adverse events in all the patients receiving the Clofarabine at the dose schedules described in the protocol (CTCAE 3.0 used).|biweekly for duration of treatment , an average of 3 months|All participants considered.|||participants|||Number
2776066|NCT00700011|Primary|Determine Frequency and Duration of Bone Marrow Responses to IV Clofarabine|The International Working Group response criteria was used. Complete remission is defined as <5 % marrow blasts without evidence of dysplasia and normalization of the peripheral blood counts, including hemoglobin >11 g/dL, neutrophil count of >1 x 10^9/L. and platelet count of >100 x 10^9/L. Patients must also be transfusion-independent and not require any recombinant erythropoietin. Partial remission (PR) is defined as: satisfying complete remission criteria if abnormal before treatment, except that blasts are reduced by 50% or more compared to pretreatment levels, but still >5 %. Stable disease is defined as: failure to achieve at least a PR but without evidence of disease progression for at least 8 weeks.Progression of disease is defined as: disease progression with worsening cytopenias. Best response of these patients is used in the determination for this outcome below.|2-3 months|All patients considered except one on the 5 mg/m2 arm who we didn't have enough time to assess response as he died within 2 weeks after receiving cycle 1.|||participants|||Number
2776067|NCT00700011|Secondary|Number of Participants With DNA Hypomethylation During the Study|Since we previously observed decreases in DNA methylation in tumor cells after in vitro treatment with Clofarabine, we compared the long interspersednuclear element-1 methylation of genomic DNA obtained from CD3-depletedperipheral blood mononuclear cells between day 1 and day 5 of each cycle of Clofarabine.|assessed twice per cycle|All participants were considered except one patient on 5 mg/m2 arm who died within 2 weeks after cycle 1, so this was unassessable.|||participants|||Number
2776068|NCT00700011|Primary|Improvement in Peripheral Blood Count and Reduction in Number of Transfusions|Hematologic improvement will be an increased Hemoglobin of 1.5 g/dL or a reduction in the need for PRBC transfusions by at least 4 units over an 8 week period, at least 100% increase and an ANC of >0.5 x 10^9/L and an absolut platelet count increase of >30 x 10^9/L for patients who start at > 20 x 10^9/L, or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%.|2-3 months|All patients considered for analysis except for one on the 5 mg/m2 arm who died within 2 weeks after cycle one making this unassessable for that patient.|||participants|||Number
2776069|NCT00699998|Secondary|Summary of All Deaths|All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.|Randomization through end of study (30-month visit)|All randomized participants|||participants|||Number
2776070|NCT00699998|Secondary|Economic and Quality of Life Outcomes|Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.|Baseline and follow-up (24 months)|All randomized participants (combined <75 years and 75 years and older) with SAQ data.|||units on a scale||Standard Deviation|Mean
2776071|NCT00699998|Secondary|Genotyping Related to Drug Metabolism|Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.|Baseline|All randomized participants who provided a DNA sample.|||percentage participants with geneotype|||Number
2776072|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)|C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and Month 6|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months.|||milligrams per liter (mg/L)||Standard Error|Geometric Mean
2776073|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 6 Months|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months.|||picograms per milliliter (pg/mL)||Standard Error|Geometric Mean
2776074|NCT00699998|Secondary|Platelet Aggregation Measures|Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 12 Months|All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12.|||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
2776075|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke|The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
2776076|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
2776077|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death and MI|The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
2776098|NCT00699816|Primary|Recurrence Free Survival(RFS)|RFS was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||months||95% Confidence Interval|Median
2776078|NCT00699998|Primary|Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants|||percentage of participants with an event|||Number
2776079|NCT00699972|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set|||Percent Change||Full Range|Median
2776080|NCT00699972|Secondary|Percentage of Participants Who Were Responders|A responder was a participant who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set; Last Observation Carried Forward (LOCF)|||Percentage of Participants|||Number
2776081|NCT00699972|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set included all participants who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.|||Percent Change in seizure frequency||Full Range|Median
2776082|NCT00699907|Primary|Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Stroma|ErbB4 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
2776083|NCT00699907|Primary|Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Epithelium|ErbB4 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
2776084|NCT00699907|Primary|Tyrosine Kinase V-erb-b2 Erythroblastic Leukemia Viral Oncogene Homolog-4 (ErbB4) Expression in Ovarian Endosalpingiosis|ErbB4 levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
2776085|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Stroma|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
2776086|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Epithelium|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
2776087|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
2776088|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma|CSF-1 levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
2776089|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium|CSF-1 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
2776090|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis|"CSF-1 levels were measured by immunohistochemistry (IHC).~The modified H-Score assess extent of nuclear immunoreactivity applicable to steroid receptors.~The modified H-scores total range is 0-300. A lower modified H-score indicates weakly staining nuclei. A higher modified H-score indicated strongly staining nuclei.~This applies to all measures."|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Modified H-Score||Full Range|Median
2776091|NCT00699842|Secondary|Safety With Dose Escalation|Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.|2 years|||||||
2776092|NCT00699842|Primary|Determine CR, PR, and Rate of Stable Disease in MDS Patients|Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide|2 years|||||||
2776093|NCT00699816|Secondary|Cancer-specific Survival Rate|Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||percentage of participants|||Number
2776094|NCT00699816|Secondary|Overall Survival(OS) Rate|Overall survival rate was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||percentage of participants|||Number
2776095|NCT00699816|Primary|Recurrence Free Survival(RFS) Rate|RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||percentage of participants|||Number
2776096|NCT00699816|Secondary|Cancer-specific Survivals|Cancer-specific survival was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||months||95% Confidence Interval|Median
2776097|NCT00699816|Secondary|Overall Survival(OS)|Overall survival was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)||||months||95% Confidence Interval|Median
2776326|NCT00697593|Primary|Biochemistry - Glutamyl Transferase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values|||IU/L||Standard Deviation|Mean
2776099|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').|Follow-up Visit 8 (Week 139)|The ITT population was all randomized subjects with with EQ-5D analyzed.|||Participants|||Number
2776100|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').|Week 24|The ITT population was all randomized subjects with with EQ-5D analyzed.|||Participants|||Number
2776101|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').|Week 16|The ITT population was all randomized subjects with with EQ-5D analyzed.|||Participants|||Number
2776102|NCT00699751|Other Pre-specified|Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776103|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776104|NCT00699751|Other Pre-specified|Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776105|NCT00699751|Other Pre-specified|Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776106|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.|At Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776107|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.|At Week 24|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776266|NCT00698685|Primary|Non-relapse Mortality at or Before Day 100|The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin's disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).|Day 100 after transplant|All participants who received at least 1 day of treatment.|||Participants|||Number
2776108|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.|At Week 16|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776109|NCT00699751|Other Pre-specified|Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776110|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects|||Scores on a scale||Full Range|Median
2776111|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 24|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
2776112|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 16|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
2776113|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 8|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
2776114|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 0|Participants in The ITT population and with ECOG analyzed|||Participants|||Number
2776115|NCT00699751|Secondary|Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline|ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.|From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776116|NCT00699751|Secondary|Time to Occurrence of First Start of Any Other Anti-cancer Treatment|The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776274|NCT00698581|Secondary|The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
2776117|NCT00699751|Secondary|Time to Occurrence of First Spinal Cord Compression|The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first spinal cord compression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776118|NCT00699751|Secondary|Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention|The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776119|NCT00699751|Secondary|Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral|The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776120|NCT00699751|Secondary|Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms|The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first use of radioisotopes until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776121|NCT00699751|Secondary|Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms|The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first EBRT until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776122|NCT00699751|Secondary|Time to First Skeletal Related Event (SRE)|A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first first SRE until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776123|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period|PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to End of Treatment (Week 24; 4 weeks post last injection)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
2776124|NCT00699751|Secondary|Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
2776125|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA up to Week 12|PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline up to Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
2776126|NCT00699751|Secondary|Percentage Change From Baseline in PSA at Week 12|PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percent change||Standard Error|Least Squares Mean
2776127|NCT00699751|Secondary|Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
2776128|NCT00699751|Secondary|Percentage of Participants With PSA Response at Week 12|PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
2776142|NCT00699699|Primary|Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks|Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks|||Percentage of participants|||Number
2776129|NCT00699751|Secondary|Time to Prostate Specific Antigen (PSA) Progression|The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first PSA progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects|||Months||95% Confidence Interval|Median
2776130|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment|ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline During the 24 Week Treatment|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
2776131|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percent change||Standard Error|Least Squares Mean
2776132|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP up to Week 12|ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
2776133|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at Week 12|ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage change||Standard Error|Least Squares Mean
2776134|NCT00699751|Secondary|Percentage of Participants With Total ALP Normalization at Week 12|The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
2776135|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
2776136|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at Week 12|ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure|||Percentage of participants|||Number
2776137|NCT00699751|Secondary|Time to Total Alkaline Phosphatase (ALP) Progression|The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first ALP progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects.|||Months||95% Confidence Interval|Median
2776138|NCT00699751|Primary|Overall Survival|Overall survival was defined as the time from date of randomization to the date of death.|From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)|The intent-to-treat (ITT) population was defined as all randomized subjects.|||Months||95% Confidence Interval|Median
2776139|NCT00699699|Secondary|Patients' Satisfaction After 6 Weeks of Treatment|"Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied)"|6 weeks|There were 1260 patients who had evaluable PGE after 6 weeks|||Participants|||Number
2776140|NCT00699699|Secondary|Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety|"Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8))"|Baseline and after 6 weeks of treatment|There were 1260 patients who had evaluable PGE at both baseline and after 6 weeks|||PGE scale points||Standard Deviation|Mean
2776141|NCT00699699|Secondary|Change From Baseline in the PF-10 Score After 6 Weeks|Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks|||PF-10 score points||Standard Deviation|Mean
2776143|NCT00699660|Secondary|Resource Utilization|time spent administering the exam|same day||||minutes||Standard Deviation|Mean
2776147|NCT00699608|Secondary|Coordination Score, as Assessed by the Linear Analogue Rating Scales|"Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall Coordination score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired."|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||points on a scale||Standard Error|Least Squares Mean
2776148|NCT00699608|Secondary|Mood Score, as Assessed by the Linear Analogue Rating Scales|"Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall Mood score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired."|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||points on a scale||Standard Error|Least Squares Mean
2776149|NCT00699608|Secondary|Sedation Score, as Assessed by the Linear Analogue Rating Scales|"The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their usual state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score."|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||points on a scale||Standard Error|Least Squares Mean
2776150|NCT00699608|Secondary|3-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||milliseconds||Standard Error|Least Squares Mean
2776151|NCT00699608|Secondary|1-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||milliseconds||Standard Error|Least Squares Mean
2776152|NCT00699608|Secondary|3-Back Percentage of Correct Responses|"Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In 3-back tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of match trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min."|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||percentage of responses||Standard Error|Least Squares Mean
2776153|NCT00699608|Secondary|1-Back Percentage of Correct Responses|"The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., one-back). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of match trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes."|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||percentage of responses||Standard Error|Least Squares Mean
2776154|NCT00699608|Secondary|Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||number of substitutions||Standard Error|Least Squares Mean
2776163|NCT00699582|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.|||Percentage of Participants|||Number
2776155|NCT00699608|Secondary|Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||number of substitutions||Standard Error|Least Squares Mean
2776156|NCT00699608|Secondary|Critical Flicker Fusion Test-Overall Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||hertz||Standard Error|Least Squares Mean
2776157|NCT00699608|Secondary|Critical Flicker Fusion Test -Descending Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||hertz||Standard Error|Least Squares Mean
2776158|NCT00699608|Secondary|Critical Flicker Fusion Test-Ascending Threshold|Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||hertz||Standard Error|Least Squares Mean
2776159|NCT00699608|Secondary|CTT Mean Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||milliseconds||Standard Error|Least Squares Mean
2776160|NCT00699608|Secondary|Mean Tracking Error (MTE) Assessed During the CTT|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||pixels||Standard Error|Least Squares Mean
2776161|NCT00699608|Primary|Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)|Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all subjects who gave informed consent, were randomised, and received at least one dose of double-blind medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.|||pixels||Standard Error|Least Squares Mean
2776162|NCT00699582|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set with Complex Partial plus Secondarily Generalized Seizures at Pre-randomization. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.|||Percent Change||Full Range|Median
2776275|NCT00698581|Secondary|The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
2776164|NCT00699582|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Doubleblind Phase. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.|||Percent Change||Full Range|Median
2776165|NCT00699556|Secondary|Craving for Alcohol|Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score.|first measurement during laboratory session (+60 minutes after beginning of laboratory session)||||units on a scale||Standard Error|Mean
2776166|NCT00699556|Primary|Number of Drinks Consumed During an Ad-libitum Drinking Period|Participants are presented with alcohol beverages and allowed to drink at their leisure.|Two hour ad-libitum drinking period during laboratory session||||drinks||Standard Deviation|Mean
2776167|NCT00699491|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||months||95% Confidence Interval|Median
2776168|NCT00699491|Secondary|Progression Free Survival Rate|Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.|At 6 months|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||percentage of patients||95% Confidence Interval|Number
2776169|NCT00699491|Secondary|Progression Free Survival (PFS) (Phase II)|Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.|Time from registration to documentation of disease progression, up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||months||95% Confidence Interval|Median
2776170|NCT00699491|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.|Up to 5 years|No patients were eligible for this endpoint.||||||
2776171|NCT00699491|Secondary|Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)|Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.|Up to 5 years|All patients that received protocol treatment were evaluable for this endpoint.|||participants|||Number
2776172|NCT00699491|Primary|Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)|"A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.~Complete Response (CR): All of the following must be true:~Disappearance of all target and non-target lesions.~Each target lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.~The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach."|Up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.|||percentage of patients with response||90% Confidence Interval|Number
2776173|NCT00699491|Primary|Recommended Dose Level for Phase II Testing (RPTD) (Phase I)|"The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.~Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:~Any grade 4 hematologic toxicity~Hyperglycemia that cannot be stably controlled with diabetic medication~Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)"|During first course|Patients registered to the Phase I portion of the protocol were analyzed for this endpoint. One patient in Dose Level -1, one patient in Dose Level -2, and two patients in Dose Level -2B discontinued study treatment during Cycle 1 for reasons unrelated to toxicity and were excluded from this endpoint.|||DLTs|||Number
2776174|NCT00699413|Secondary|Hunger|Change in hunger score measured at baseline and 12 weeks|Measured at baseline and 12 weeks|Data were not collected||||||
2776175|NCT00699413|Secondary|Percent Body Fat|Change in percent body fat measured at baseline and 12 weeks|Measured at baseline and 12 weeks|Data were not collected||||||
2776176|NCT00699413|Secondary|Insulin Activity|Change in insulin activity measured at baseline and 12 weeks|Measured at baseline and 12 weeks|Data were not collected||||||
2776177|NCT00699413|Primary|Body Mass Index|Change in Body Mass Index measurement at baseline and 12 weeks|measured at baseline and 12 weeks|Data were not collected. Previously reported data were incorrect and do not reflect a change in BMI from baseline to 12 weeks. Only basic demographic information was collected at baseline and no outcome measures were captured. The study was terminated prior to the 12 week intervention end and no data were collected at the second time point.||||||
2776178|NCT00699400|Secondary|Number of Miscarriages|Number of pregnancy outcomes reported as spontaneous abortions|Anytime after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.|||Number of Miscarriages|Participants||Number
2776179|NCT00699400|Secondary|Number of Clinical Pregnancies|Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.|At time of ultrasound after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.|||Number of Clinical Pregnancies|Participants||Number
2776180|NCT00699400|Secondary|Implantation Rate|Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles|At time of ultrasound after embryo transfer||||Implantation Rate (%)|Participants|Standard Deviation|Mean
2776181|NCT00699400|Secondary|Oocyte Survival Rate|Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle|At time of fertilization||||Oocyte survival rate (%)|Participants|Standard Deviation|Mean
2776182|NCT00699400|Secondary|Number of Oocytes Thawed||At start of thawing cycle||||Number of oocytes thawed|Participants||Number
2776183|NCT00699400|Secondary|Number of Oocytes Frozen||At cryopreservation||||Number of Oocytes Frozen|Participants||Number
2776184|NCT00699400|Secondary|Number of Live Babies||Birth of one or more live babies||||Number of live births|||Number
2776185|NCT00699400|Secondary|Oocyte Level Live Birth Rate|Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes|Birth of one or more live babies||||% of all oocytes thawed|Participants||Number
2776186|NCT00699400|Primary|Thawing Cycle Level Live Birth Rate|Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.|Birth of one or more live babies|Live birth rate per thaw cycle(%)|||% of oocytes thawed per cycle|Participants|95% Confidence Interval|Mean
2776187|NCT00699374|Secondary|European Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state."|Day 1 of each cycle|Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.||||||
2776188|NCT00699374|Secondary|Time to Tumor Progression (TTP)|Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population|||Weeks|Participants|95% Confidence Interval|Median
2776189|NCT00699374|Secondary|Progression-Free Survival (PFS)|The period from randomization until disease progression or death.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population|||Weeks|Participants|95% Confidence Interval|Median
2776190|NCT00699374|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population, all randomized participants where participants were classifed according to the randomized treatment arm regardless of what treatment, if any, was received.|||Weeks|Participants|95% Confidence Interval|Median
2776191|NCT00699348|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 52|Safety population.|||participants|||Number
2776192|NCT00699348|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|PP population.|||percentage of participants|||Number
2776193|NCT00699348|Secondary|Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.|||days||Full Range|Median
2776194|NCT00699348|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.|||percentage of participants||95% Confidence Interval|Number
2776195|NCT00699348|Secondary|Change in Hemoglobin Concentration Between Reference SVP and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week 0 and Week 17 up to Week 24|PP Population.|||g/dL||Standard Deviation|Mean
2776210|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with self-care~I have some problems washing or dressing myself~I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
2776196|NCT00699348|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants who received at least 1 dose of C.E.R.A. and for whom data for at least 1 follow-up variable was available with the exception of participants who did not fulfill the protocol specified inclusion criteria for this analysis set.|||percentage of participants||95% Confidence Interval|Number
2776197|NCT00699335|Secondary|Physician's Final Assessment of the Tolerability of Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
2776198|NCT00699335|Secondary|Physician's Assessment of the Adhesion Properties of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
2776199|NCT00699335|Primary|EQ-5D (Optional): Visual Analogue Scale|Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2776200|NCT00699335|Primary|EQ-5D (Optional): European Index Score|Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2776201|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I am not anxious or depressed~I am moderately anxious or depressed~I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)||||Units on a scale||Standard Deviation|Mean
2776202|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I am not anxious or depressed~I am moderately anxious or depressed~I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
2776203|NCT00699335|Secondary|Patient's Assessment of the Acceptance of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
2776204|NCT00699335|Secondary|Physician's Assessment of the Skin Tolerability of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
2776205|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no pain or discomfort~I have moderate pain or discomfort~I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2776206|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no pain or discomfort~I have moderate pain or discomfort~I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
2776207|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with performing my usual activities~I have some problems with performing my usual activities~I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)||||Units on a scale||Standard Deviation|Mean
2776208|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with performing my usual activities~I have some problems with performing my usual activities~I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
2776209|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with self-care~I have some problems washing or dressing myself~I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2776233|NCT00699140|Secondary|Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)|The time taken for the platelet count to reach ≥ 50x10^9/L from first dose|At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population but only 13 responded to the treatment|||days||Full Range|Median
2776211|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems in walking around~I have some problems in walking around~I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2776212|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems in walking around~I have some problems in walking around~I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Participants|||Number
2776213|NCT00699335|Primary|Physician's Final Assessment of the Efficacy of Therapy With Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed|||Participants|||Number
2776214|NCT00699335|Primary|Patient's Assessment of Pain Severity Score|Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2776215|NCT00699283|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)|"The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs.~The Outcome Measure was only pre-specified for the Brivaracetam (BRV) 50 mg Arm"|||percentage of subjects||95% Confidence Interval|Number
2776216|NCT00699218|Secondary|Inventory of Depressive Symptomatology|Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression.|5 weeks||||units on a scale||Standard Deviation|Mean
2776217|NCT00699218|Primary|Hamilton Rating Scale for Depression (HAM-D)|Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.|5 weeks||||units on a scale||Standard Deviation|Mean
2776218|NCT00699192|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||Percentage of patients|||Number
2776219|NCT00699192|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)|Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||Percentage of patients|||Number
2776220|NCT00699192|Secondary|Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8|A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||Percentage of patients|||Number
2776221|NCT00699192|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.|||mmHg||Standard Deviation|Mean
2776222|NCT00699192|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used.|||mmHg||Standard Deviation|Mean
2776223|NCT00699153|Secondary|Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 3-18 (Each follow-up Visit 4-7)|Intent to treat population.|||Composite scores||Standard Deviation|Mean
2776224|NCT00699153|Secondary|Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each visit: Visit 4-7, postoperative days 3-18|Intent to treat population|||participants|||Number
2776225|NCT00699153|Primary|Participants With Grade 0 (no) Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative day 8 (Visit 5)|Intent to treat population|||participants|||Number
2776226|NCT00699153|Primary|Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative day 8 (Visit 5)|Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.|||participants|||Number
2776227|NCT00699140|Secondary|Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA|The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population|||seroconversions|||Number
2776228|NCT00699140|Secondary|Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)|Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator's judgment) was listed.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population|||participants|||Number
2776229|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received at least one infusion with the study drug.|||percentage of infusions|||Number
2776230|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Patients|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received one infusion with the study drug.|||percentage of patients|||Number
2776231|NCT00699140|Secondary|Regression of Hemorrhages.|"Percentage of subjects with regression of hemorrhages of Types 1 to 3:~Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding~Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses~Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased~Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)"|First 10 to14 days since the first infusion day (Day 1)|ITT population: patients who received at least one infusion of the study drug|||percentage of subjects||95% Confidence Interval|Number
2776232|NCT00699140|Secondary|Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)|Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)|At any time during the study period (up to 3 months [90 days])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population only 13 responded to the treatment|||days||Full Range|Median
2776276|NCT00698581|Secondary|The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
2776234|NCT00699140|Secondary|Maximum Platelet Level Reached During the Follow-up Period|Platelet count was measured at various time points in the follow-up period after infusion.|During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|The maximum platelet counts were taken from the population who responded to treatment (platelet count ≥ 50x10^9/L). If any patient received banned medication due to ITP progression during the study, the values obtained after patients received treatment were excluded.|||platelets x 10^-9/L||Full Range|Median
2776235|NCT00699140|Primary|Responder Patients|The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.|At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).|All 18 subjects received at least one infusion (at any dose) of IGIV3I Grifols and were included in the intent-to-treat (ITT) population for efficacy and safety analysis.|||percentage of subjects||95% Confidence Interval|Number
2776236|NCT00699010|Primary|Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)|"Do you dislike or like the drug effect you are feeling now? This question was rated on a 1 to 29 point VAS scale that was anchored in the center with neither like nor dislike (14), on the left with dislike an awful lot (1), and on the right with like an awful lot (29)."|Effects assessed at 0.5 hours after dosing.|Study completers and per protocol|||score on a scale||Standard Error|Mean
2776237|NCT00698997|Secondary|Autism Severity|Autism severity was calculated using the Calibrated Severity Scores, derived by using tables in publications by Gotham, Pickles, & Lord( 2012) (Esler, Bal, Guthrie, Weismer, and Lord, 2015). We identified the severity score listed in the CSS table that was associated with a subject's ADOS-2 total score for the ADOS module that was administered to each subject at each of four time points - at entry into the project, and 6 months, 12 months, and 24 months after enrollment. The ADOS Calibrated Severity Score scale range is 1-10, with lower scores representing milder and less numerous symptoms and higher scores representing more severe and more numerous systems. Scores 1-3 represent few to no ASD symptoms, scores of 4-5 represent mild to moderate symptoms and concerns related to ASD, and scores of 6-10 represent moderate to severe symptom severity.|24 months||||units on a scale||Standard Deviation|Mean
2776238|NCT00698997|Secondary|Adaptive Behavior Age Equivalent Scores|Adaptive behavior age equivalent was characterized by averaging the means of the age equivalents in months of the four domain scores from the Vineland Adaptive Behavior Scales - Second edition (VABS) because the manual does not provide developmental ages corresponding to total scores that could be used to construct quotient scores. Data were provided by parents who were not naïve to group assignment. The Vineland Adaptive Behavior Scales 2 provide a standardized measure of adaptive behavior in four domains: motor, language, social, and activities of daily living. Information is gathered from parents via parent questionnaire. The lower the score on each domain score and the overall score, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.|24 months||||months||Standard Deviation|Mean
2776239|NCT00698997|Secondary|Overall Developmental Quotient (DQ)|Overall DQ was calculated by averaging the Time 1 (baseline) age equivalence scores of the two language and two nonverbal subtests from the Mullen Scales of Early Learning (MSEL), dividing by child age in months, and multiplying by 100 to create a quotient score, in order to capture the full range of variability of the sample, since many children fell below the basal standard score. The Mullen Scales of Early Learning (MSEL) is a developmental test with five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. Gross motor score was not used for the calculations. The lower the score on this scale, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.|24 months||||developmental quotient||Standard Error|Mean
2776240|NCT00698997|Primary|Language Age Equivalent|Composite language measure consisting of an average of the Expressive Language and the Receptive Language age equivalent scores from the Mullen Scales of Early Learning.The Mullen Scales of Early Learning (MSEL) is a developmental test with five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. The lower the score on this scale, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.|24 months||||language age in months||Standard Deviation|Mean
2776241|NCT00698932|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24|Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||Percentage of Participants|||Number
2776242|NCT00698932|Secondary|Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.|||mg*min/dL||Standard Error|Mean
2776267|NCT00698685|Primary|Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).|The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.|Day 100 after transplant.|All participants who completed treatment and underwent allogeneic transplant.|||participants|||Number
2776243|NCT00698932|Secondary|Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.|||mmol*min/L||Standard Error|Mean
2776244|NCT00698932|Secondary|Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2776245|NCT00698932|Secondary|Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mmol/L||Standard Error|Mean
2776246|NCT00698932|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||percent||Standard Error|Mean
2776247|NCT00698867|Secondary|Incidence of Surviving Elbows|Proportion of elbows that did not require revision or removal|Up to 5 Years|Subjects with complete 5 year data.|||Proportion of Elbows|Elbows|95% Confidence Interval|Number
2776248|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength|Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
2776249|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability|Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
2776250|NCT00698867|Primary|Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs|This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
2776251|NCT00698867|Primary|Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction|This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.|5 Years||||Scores on a scale|Elbows|Standard Deviation|Mean
2776252|NCT00698867|Primary|Patient Derived American Shoulder and Elbow Society Score (ASES) Function|This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.|5 Years|Discovery elbows|||Scores on a scale|Elbows|Standard Deviation|Mean
2776253|NCT00698867|Primary|American Shoulder and Elbow Society Score (ASES) Pain Assessment|This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.|5 years|Discovery Elbow|||Scores on a scale|Elbows|Standard Deviation|Mean
2776254|NCT00698841|Secondary|Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:<LLN to 10.0, Grade 2:<10.0 to 8.0, Grade 3:<8.0 to 6.5, Grade 4:<6.5. Platelets Grade 1:LLN to 75.0*10^9/L, Grade 2:<75.0 to 50.0*10^9/L, Grade 3:<50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L. White blood cells Grade 1:<LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3:<2.0 to 1.0*10^9/L, Grade 4:<1.0*10^9/L. Neutrophils Grade 1:<LLN to 1.5*10^9/L, Grade 2:<1.5 to 1.0*10^9/L, Grade 3:<1.0 to 0.5*10^9/L, Grade 4:<0.5*10^9/L.|At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up|All participants who received at least 1 dose of cetuximab.|||Participants|||Number
2776265|NCT00698815|Primary|18 Week Progression-free Survival (PFS) Rate|The 18 week progression-free survival rate was defined as the proportion of patients that were alive and progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.|At 18 weeks||||percentage of participants||95% Confidence Interval|Number
2776255|NCT00698841|Primary|Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point|The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.|Predose Day 1 (Baseline) to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.|||msec||Standard Error|Mean
2776256|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)|BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1&2:<LLN-130, Grade 3:<130-120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab|||Participants|||Number
2776257|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab|||Participants|||Number
2776258|NCT00698841|Secondary|Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening.|Baseline through Cycle 1 (28 days), continuously||||Participants|||Number
2776259|NCT00698841|Secondary|Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.|Baseline through Cycle 1 (28 days), continuously|All participants who received at least 1 dose of cetuximab.|||Participants|||Number
2776260|NCT00698841|Secondary|Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate|12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.|||Participants|||Number
2776261|NCT00698841|Primary|Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline|12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.|||Participants|||Number
2776262|NCT00698815|Secondary|Overall Survival (OS)|OS is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)||||months||95% Confidence Interval|Median
2776263|NCT00698815|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 3 years)||||percentage of participants||95% Confidence Interval|Number
2776264|NCT00698815|Secondary|PFS|PFS was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 3 years)||||months||95% Confidence Interval|Median
2776277|NCT00698581|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Week 1 up to Week 17|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.|||proportion of subjects||95% Confidence Interval|Number
2776278|NCT00698516|Secondary|Overall Survival|Overall survival is defined as the time from initiation of investigational product to death due to any cause. For participants who did not die, the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
2776279|NCT00698516|Secondary|Time to Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Time to response is defined as the time from initiation of investigational product to the time of first documented response (CR or PR).|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR|||weeks||95% Confidence Interval|Median
2776280|NCT00698516|Secondary|Duration of Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Duration of response is defined as the time from start of response (CR or PR) until progression or death due to any cause. For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR|||weeks||95% Confidence Interval|Median
2776281|NCT00698516|Secondary|Number of Participants With a Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||participants|||Number
2776282|NCT00698516|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|Tumor response was determined using the RECIST guidelines.CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since treatment started; PD, >=20% increase in sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||participants|||Number
2776283|NCT00698516|Secondary|PFS - Overall|Progression-free survival at any site was defined as the time from initiation of investigational product to the time of first documented disease progression or death due to any cause. Progression was assessed using the RECIST guidelines: >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion (s). For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
2776284|NCT00698516|Primary|Percentage of Participants With Progression-free Survival (PFS) at 3 Months|PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.|3 months|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication|||percentageof participants|||Number
2776285|NCT00698451|Secondary|The Secondary Efficacy Endpoints is Duration of Objective Response.|Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|ITT|||Days||Full Range|Median
2776286|NCT00698451|Primary|The Primary Efficacy End Point is the Number of Patients With an Objective Response.|Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)|ITT|||Participants|||Number
2776287|NCT00698204|Secondary|Evaluation of Pain Severity at 5000 cGy Radiation|Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable|5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)|Only subjects who were still taking the study drug (celecoxib or placebo) when cumulative radiation dose of 5000 cGy was reached are included in this analysis (19 of 20 in each group were analyzed).|||units on a scale||Standard Deviation|Mean
2776320|NCT00697593|Primary|Urinalysis - Glucose|Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
2776288|NCT00698204|Primary|Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy|"Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9.~The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups."|5 weeks from start of radiation therapy (5000 cGy)|Subjects participating in the study as they reached a cumulative dose of 5000 cGy were included. One subject in the celecoxib group withdrew prior to reaching 5000 cGy.|||units on a scale||Standard Deviation|Mean
2776289|NCT00698139|Secondary|Changes in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.|baseline and 6 hours||||ng/L||Standard Deviation|Mean
2776290|NCT00698139|Secondary|Changes in Thoracic Impedence|Impedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.|baseline and 6 hours||||ohm||Standard Deviation|Mean
2776291|NCT00698139|Primary|Change in Cardiac Output (CO)|The difference between post and pre CO|baseline and 6 hours||||L/min||Standard Deviation|Mean
2776292|NCT00698035|Secondary|Change in Vaginal Epithelium Scores|During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.|Baseline, 12 weeks|Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy|||units on a scale||Standard Deviation|Mean
2776293|NCT00698035|Secondary|Sexual Satisfaction|"Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked Overall, how satisfactory to you is your sexual relationship with your partner? Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory)."|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at all 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)|||units on a scale||Standard Deviation|Mean
2776294|NCT00698035|Secondary|Sexual Quality of Life|Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)|||units on a scale||Standard Deviation|Mean
2776295|NCT00698035|Secondary|Total Testosterone Levels|By serum ultrasensitive total testosterone test (Quest Diagnostics)|12 weeks|Per protocol, participants assigned to the Testosterone arm who completed 12 weeks of assigned treatment and had testosterone measurement at baseline, 4 weeks and 12 weeks.|||ng/dl||Standard Deviation|Mean
2776296|NCT00698035|Primary|Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range|Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.|12 Weeks|Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.|||participants|||Number
2776297|NCT00698035|Secondary|Matched E2 by Commercial and Research (RIA) Analyses|Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women|baseline, 4 weeks|Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs|||pg/ml||Standard Deviation|Mean
2776298|NCT00698035|Secondary|Serum Estradiol (E2)|serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)|12 weeks|Per protocol, participants who completed 12 weeks of assigned treatment|||pg/ml||Standard Deviation|Mean
2776299|NCT00698022|Secondary|The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers.||28 days|||||||
2776300|NCT00698022|Secondary|The Secondary Study Objectives Are to Determine the Mean Percent Change in Baseline Body Weight; and the Proportion of Subjects That Gain Less Than 5% and Less Than 7% of Their Baseline Body Weight in the Treatment Groups.||28 days|||||||
2776301|NCT00698022|Primary|Change in Weight (kg) From Baseline to Day 28.|Change in weight (kg) was compared at Baseline and Day 28 for all subjects in all treatment arms.|baseline and 28 days||||kilograms||Standard Error|Mean
2776302|NCT00698009|Primary|Number of Participants Infused Haploidentical Donor-derived Natural Killer (NK) Cells and Low-dose Interleukin-2 (IL-2)|Feasibility of an infused allogeneic donor NK cell product and IL-2 following a cyclophosphamide and fludarabine preparative regimen to treat relapsed neuroblastoma after autologous peripheral blood stem cell (PBSC) transplant where feasibility is defined as being able to infuse NK cells on day 0.|21 days, up to 1 year|||||||
2776303|NCT00698009|Primary|Participant Disease Response|Neuroblastoma International Response Criteria: Complete Response (CR): No evidence of disease (primary and metastasis) clinically & radiographic studies, (homovanillic acid (HVA)/vanillylmandelic acid (VMA) normal). Very Good Partial Response (VGPR): >90% reduction in primary tumor, resolution all metastatic tumor except bone. No new bone lesions and improvement on scan of all pre-existing lesions; HVA/VMA decreased >90%. Partial Response (PR): 50-90% reduction primary and all measurable metastatic lesions, 0-1 bone marrow samples with tumor; scans of bone lesions same as VGPR. HVA/VMA decreased 50-90%. Mixed Response (MR): > 50% reduction any measurable disease (primary or metastases); no new lesions; <25% increase in any existing lesion (exclude bone marrow evaluation). No Response (NR): No new lesions; < 25% increase in existing lesion. Progressive Disease (PD): Any new lesions. Increase <25% in measurable lesion, previous negative bone marrow positive for tumor.|1 Year for overall patient response, or until disease progression|||||||
2776304|NCT00697827|Secondary|Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success.|24 months||||participants|||Number
2776305|NCT00697827|Primary|Zurich Claudication Questionnaire(ZCQ)|The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of < 2.5 points for patient satisfaction at 24 months.|24 months||||participants|||Number
2776306|NCT00697801|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired).|baseline, week 6|Patients with available data at specified time points are included in the analysis population.|||percentage of predicted FEV1||Standard Deviation|Mean
2776307|NCT00697801|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.|||units on a scale||Standard Deviation|Mean
2776308|NCT00697801|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.|||units on a scale||Standard Deviation|Mean
2776309|NCT00697788|Secondary|Heart Rate|Heart Rate recorded off EKG in beats per minute|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration||||heart beats per minute||Standard Deviation|Mean
2776310|NCT00697788|Secondary|Oxygen Saturation|Pulse oximetry was used to measure oxygen saturation.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration||||Percent of Hemoglobin Saturated||Standard Deviation|Mean
2776311|NCT00697788|Secondary|Presence of Arrhythmias.|Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|EKG was analyzed on each participant looking for presence of arrhythmias. None were detected.|||Participants|||Count of Participants
2776312|NCT00697788|Primary|Percent Change in Mean Arterial Pressure (MAP)|Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.|10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration|Acutely burned pediatric patients intubated with burns >=20% between 2 and 19 years of age requiring escalating doses of morphine and midazolam|||% change||Standard Deviation|Mean
2776313|NCT00697697|Primary|Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.|||participants|||Number
2776314|NCT00697697|Primary|Number of Patients With Treatment Emergent Adverse Events Related to Study Drug|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.|||participants|||Number
2776315|NCT00697619|Primary|Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .||Baseline, the first, second and third month||||nM /mM||Standard Error|Median
2776316|NCT00697593|Primary|Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis|Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above|Week 12 / Early Termination|||||||
2776317|NCT00697593|Primary|Urinalysis - Leukocytes Esterase|Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
2776318|NCT00697593|Primary|Urinalysis - Nitrite|Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
2776319|NCT00697593|Primary|Urinalysis - Blood|Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values|||participants|||Number
2776321|NCT00697593|Primary|Urinalysis - Ketones|Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine|Week 12 / Early Termination||||participants|||Number
2776343|NCT00697593|Secondary|Static Physician's Global Assessment (sPGA)|Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).|12 Weeks/Early Termination|Safety Population|||participants|||Number
2776344|NCT00697593|Primary|Hematology - Hematocrit|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values|||packed cell volume||Standard Deviation|Mean
2776345|NCT00697541|Primary|Tmax - Time to Maximum Plasma Concentration|time to maximum plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose||||Hours||Full Range|Mean
2776346|NCT00697541|Primary|AUC - Area Under the Curve of Brimonidine|"Area under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method~After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value.~Thus, no PK analysis could be performed for 0.18% COL-118 facial gel.~After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated."|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose||||pg*hr/mL||Full Range|Mean
2776347|NCT00697541|Primary|Cmax - Maximum Systemic Concentration of Brimonidine|Maximum observed plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose||||pg/mL||Full Range|Mean
2776348|NCT00697515|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 7 days|SP|||msec||Standard Deviation|Mean
2776349|NCT00697515|Secondary|Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP|||bpm||Standard Deviation|Mean
2776350|NCT00697515|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP|||mmHg||Standard Deviation|Mean
2776351|NCT00697515|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|Safety Population (SP) defined as all subjects who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2776352|NCT00697515|Secondary|Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).|Baseline and 26 days||||Units on a scale||Standard Deviation|Mean
2776353|NCT00697515|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).|Baseline and 26 days|EEP|||Units on a scale||Standard Deviation|Mean
2776354|NCT00697515|Secondary|Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase|MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.|26 days|EEP|||Participants|||Number
2776355|NCT00697515|Secondary|Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase|The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.|Baseline and 26 days|EEP|||Units on a scale||Standard Deviation|Mean
2776356|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 days|ITT|||Participants|||Number
2776357|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7, 14, 21 and 28 days|EEP|||Participants|||Number
2776358|NCT00697515|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|EEP|||Participants|||Number
2776359|NCT00697515|Secondary|ADHD-RS With Prompts Total Score in the Crossover Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|7 days|ITT|||Units on a scale||Standard Error|Least Squares Mean
2776360|NCT00697515|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7, 14, 21 and 28 days|Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2776361|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT|||Units on a scale||Standard Error|Least Squares Mean
2776362|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT|||Units on a scale||Standard Error|Least Squares Mean
2776363|NCT00697515|Secondary|PERMP Total Score by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT|||Units on a scale||Standard Error|Least Squares Mean
2776364|NCT00697515|Primary|Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
2776365|NCT00697463|Primary|Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)|Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.|Baseline, Month 18 or 24 reported|Of 22 women with IOP who enrolled, one withdrew for personal reasons, therefore the overall number of participants analyzed is 21. The percentage of BMD change is calculated for each participant between baseline and Month 24 or between baseline and Month 18, whichever is the longer reported timeframe as some are lost to follow up by Month 24.|||percentage of BMD change||Standard Deviation|Mean
2776366|NCT00697346|Secondary|Number of Participants With Polymorphisms in Aurora A Kinase||Cycle 1 Day 1 predose|As per protocol amendment, no data was collected for polymorphisms in Aurora A Kinase.||||||
2776367|NCT00697346|Secondary|Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1|"One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype participants for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib.~wt=wild type. *28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression. Not determined = blood sample was not evaluable."|Cycle 1 Day 1 predose|Safety population included all participants who received any amount of study drug. Data is presented for one arm because the data was collected prior to the participant receiving their assigned treatment.|||participants|||Number
2776368|NCT00697346|Secondary|Duration of Response (DOR)|DOR is defined as the time from the date of first documentation of a response (either CR or PR) to the date of first documentation of progressive disease (PD) according to International Working Group (IWG) criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)|Participants from the Response-Evaluable Population who had a response of CR or PR.|||months||Full Range|Median
2776369|NCT00697346|Secondary|Best Overall Response Rate Based on Investigator's Assessment|Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions.|Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)|The response-evaluable population is defined as all participants who received at least 1 dose of alisertib and have measurable disease at baseline and have at least 1 post baseline response assessment.|||percentage of participants|||Number
2776370|NCT00697346|Primary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2776371|NCT00697346|Primary|Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2776372|NCT00697346|Primary|Accumulation Ratio (Rac) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2776373|NCT00697346|Primary|Terminal Half-Life (t1/2) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||h||Standard Deviation|Mean
2776388|NCT00697346|Primary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2776374|NCT00697346|Primary|AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2776375|NCT00697346|Primary|AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1||Cycle 1 Days 1 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2776376|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||h||Full Range|Median
2776377|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||h||Full Range|Median
2776378|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7||Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776379|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776380|NCT00697346|Primary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.|||L/h||Standard Deviation|Mean
2776381|NCT00697346|Primary|Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2776382|NCT00697346|Primary|Terminal Half Life for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.|||h||Standard Deviation|Mean
2776383|NCT00697346|Primary|AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2776384|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.|||h||Full Range|Median
2776385|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||h||Full Range|Median
2776386|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776387|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776389|NCT00697346|Primary|Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||ratio||Standard Deviation|Mean
2776390|NCT00697346|Primary|Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2776391|NCT00697346|Primary|AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2776392|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||h||Full Range|Median
2776393|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||h||Full Range|Median
2776394|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14||Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776395|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776396|NCT00697346|Primary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2776397|NCT00697346|Primary|Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2776398|NCT00697346|Primary|Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2776399|NCT00697346|Primary|Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||h||Standard Deviation|Mean
2776400|NCT00697346|Primary|AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2776401|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||h||Full Range|Median
2776402|NCT00697346|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||hours (h)||Full Range|Median
2776403|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21||Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose|PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776404|NCT00697346|Primary|Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1||Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose|Pharmacokinetic (PK) evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2776405|NCT00697346|Primary|Maximum Tolerated Dose (MTD) of Alisertib|MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.|From first dose of study drug to 30 days after the last dose (up to 422 days)|DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.|||mg BID for 7 days|||Number
2776406|NCT00697346|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:1. Grade 4 neutropenia lasting ≥7 consecutive days, 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count <25,000/mm^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide 6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (<1 week) Grade 3 fatigue 7. Treatment delay of >21 days due to failure of adequate hematologic or non-hematologic recovery from previous cycle of treatment 8. Other alisertib related non-hematologic toxicities ≥Grade 2 that, in the opinion of the investigator required a dose reduction or discontinuation of therapy with alisertib.|From first dose of study drug to 30 days after the last dose (up to 422 days)|DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.|||participants|||Number
2776407|NCT00697255|Secondary|Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|During In-Treatment Period (up to 14 weeks after first corifollitropin injection)|The All-Participants-Treated (APT) group consisted of all participants who received corifollitropin alfa. Participants were grouped according to the stage of the trial and the active treatment group (recFSH Stage Ia, hCG Stage Ib) they actually received.|||participants|||Number
2776408|NCT00697255|Secondary|Number of Participants With Pregnancy|A pregnancy test (serum or urinary hCG) was performed two to three weeks after bolus injection of hCG. In case of a positive pregnancy test vaginal and/or abdominal ultrasound scan was performed to confirm the pregnancy at 5 to 6 weeks after bolus injection of hCG and ≥10 weeks after bolus injection of hCG to confirm ongoing pregnancy.|At least 10 weeks after bolus injection of hCG (up to 13 weeks)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||participants|||Number
2776409|NCT00697255|Secondary|Percentage of Participants Who Cancelled Treatment (Cancellation Rate)|Treatment was considered cancelled if no bolus injection of hCG was administrated. Reasons of treatment failure included Adverse Event (AE)/ Serious Adverse Event (SAE), insufficient ovarian response on stimulation day 13 (no follicle ≥12 mm), insufficient ovarian response after 7 days of hCG/recFSH treatment (no follicle ≥18 mm), and multifollicular growth (≥3 follicles ≥15 mm).|Up to 3 weeks after bolus injection of hCG (up to 41 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
2776410|NCT00697255|Secondary|Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)|Monofollicular ovulation rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) and confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
2776411|NCT00697255|Secondary|Percentage of Participants With Ovulation (Ovulation Rate)|Ovulation rate was defined as the number of participants with confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
2776431|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776412|NCT00697255|Primary|Percentage of Participants With Monofollicular Response (Monofollicular Rate)|The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.|At day of bolus injection of hCG (up to 20 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).|||percentage of participants|||Number
2776413|NCT00697203|Secondary|Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB||Baseline and at 12 Weeks||||Percent Change in Ratio||Standard Error|Least Squares Mean
2776414|NCT00697203|Secondary|AEs, Lab Parameters, Vital Signs, ECG||Through 9 Months|Data not collected||||||
2776415|NCT00697203|Secondary|Percent Change of Fasting Glucose Level||12 weeks||||Percent change in mg/dL||Standard Error|Least Squares Mean
2776416|NCT00697203|Secondary|Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI||12 weeks||||Percent change in mg/dL||Standard Error|Least Squares Mean
2776417|NCT00697203|Primary|Percent Change From Baseline in HDL-C Level\n||12 Weeks||||Percent change in mg/dL||Standard Error|Least Squares Mean
2776418|NCT00697203|Primary|Absolute Change From Baseline in HDL-C Level\n||Week 12||||mg/dL||Standard Error|Least Squares Mean
2776419|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776420|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776421|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776422|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776423|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776424|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776425|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776426|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776427|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776428|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776429|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776430|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776432|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776433|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.|||Units on a scale||Standard Error|Least Squares Mean
2776434|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Radiological Abnormalities|Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
2776435|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities|Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats [RR interval]).|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
2776436|NCT00697112|Secondary|Percentage of Participants With Serious Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
2776437|NCT00697112|Secondary|Percentage of Participants With Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
2776438|NCT00697112|Secondary|Percentage of Participants With Physical Abnormalities|Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.|||percentage of participants|||Number
2776439|NCT00697112|Secondary|Body Weight||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||kilogram||Standard Deviation|Mean
2776440|NCT00697112|Secondary|Pulse Rate||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||beats per minute||Standard Deviation|Mean
2776441|NCT00697112|Secondary|Blood Pressure|Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||mmHg||Standard Deviation|Mean
2776442|NCT00697112|Secondary|Number of Participants With Body Temperature|Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic.|||participants|||Number
2776443|NCT00697112|Secondary|Body Mass Index|BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||kg/m^2||Standard Deviation|Mean
2776471|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 2|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||IU/L||Standard Deviation|Mean
2776444|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.|Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants|||Number
2776445|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants|||Number
2776446|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants|||Number
2776447|NCT00697112|Secondary|Average Proteinuria|Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||g/24 hr||Standard Deviation|Mean
2776448|NCT00697112|Secondary|Average Creatinine Clearance|Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||milliliter per minute (mL/min)||Standard Deviation|Mean
2776449|NCT00697112|Secondary|Average Blood Level of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2776450|NCT00697112|Secondary|Average Dose of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.|||milligram per day||Standard Deviation|Mean
2776451|NCT00697112|Secondary|Probability of Participant Survival|Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||probability of participant survival||95% Confidence Interval|Number
2776452|NCT00697112|Secondary|Probability of no Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than [>] 25 percent [%] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (>25% of parenchyma affected) and severe tubulitis (>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising >25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||probability of no acute rejection||95% Confidence Interval|Number
2776453|NCT00697112|Secondary|Probability of Graft Survival|Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||probability of graft survival||95% Confidence Interval|Number
2776454|NCT00697112|Primary|Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy|The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.|Baseline|Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks.|||percentage of participants||95% Confidence Interval|Number
2776455|NCT00697073|Secondary|Nature and Frequency of Adverse Events||12 Months|||||||
2776456|NCT00697073|Secondary|FARS (Friedreich's Ataxia Rating Scale)||baseline and 12 Months|||||||
2776457|NCT00697073|Primary|Change in ICARS|"International Cooperative Ataxia Rating Scale (ICARS):~ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.~Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 12 months||||ICARS points||Standard Deviation|Mean
2776458|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 3|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||pg/mL||Standard Deviation|Mean
2776459|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 2|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||pg/mL||Standard Deviation|Mean
2776460|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 1|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||pg/mL||Standard Deviation|Mean
2776461|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 3|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||nmol/L||Standard Deviation|Mean
2776462|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 2|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||nmol/L||Standard Deviation|Mean
2776463|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 1|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||nmol/L||Standard Deviation|Mean
2776464|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 3|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||pmol/L||Standard Deviation|Mean
2776465|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 2|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||pmol/L||Standard Deviation|Mean
2776466|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 1|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||pmol/L||Standard Deviation|Mean
2776467|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 3|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||IU/L||Standard Deviation|Mean
2776468|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 2|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2|||IU/L||Standard Deviation|Mean
2776469|NCT00696878|Secondary|Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||IU/L||Standard Deviation|Mean
2776470|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 3|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3|||IU/L||Standard Deviation|Mean
2776472|NCT00696878|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1|||International Units (IU)/L||Standard Deviation|Mean
2776473|NCT00696878|Secondary|Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy|The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa|||percentage of participants|||Number
2776474|NCT00696878|Secondary|Number of Participants With Ongoing Pregnancy in Any FTET Cycle|After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET within an FTET cycle|Participants who received corifollitropin alfa and had ET in any FTET cycle|||participants|||Number
2776475|NCT00696878|Secondary|Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.|From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
2776476|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3|"Miscarriage: Loss of the fetus without induction or instrumentation, also known as spontaneous abortion. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan."|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
2776477|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3|"Miscarriage: Loss of the fetus without induction or instrumentation, also known as spontaneous abortion. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan."|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
2776478|NCT00696878|Secondary|Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3|||participants|||Number
2776479|NCT00696878|Secondary|Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776480|NCT00696878|Secondary|Implantation Rate for Participants With ET|The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.|Approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ET|||percentage of embryos||Standard Deviation|Mean
2776481|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3|"The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa in Treatment Cycle 3|||number of embryos||Standard Deviation|Mean
2776482|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2|"The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa in Treatment Cycle 2|||number of embryos||Standard Deviation|Mean
2776483|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1|"The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa in Treatment Cycle 1|||number of embryos||Standard Deviation|Mean
2776484|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3|"The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had ET in Treatment Cycle 3|||participants|||Number
2776485|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2|"The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had ET in Treatment Cycle 2|||participants|||Number
2776486|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1|"The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had ET in Treatment Cycle 1|||participants|||Number
2776487|NCT00696878|Secondary|Number of Embryos Transferred|ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had ET|||number of embryos||Standard Deviation|Mean
2776488|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3|"At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3|||number of embryos||Standard Deviation|Mean
2776489|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2|"At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3|||number of embryos||Standard Deviation|Mean
2776490|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1|"At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality."|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3|||number of embryos||Standard Deviation|Mean
2776491|NCT00696878|Secondary|Fertilization Rate|The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had IVF and/or ICSI|||percentage of oocytes||Standard Deviation|Mean
2776543|NCT00696800|Secondary|Serum Estradiol (E2) Levels During Stimulation|Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available.|||pmol/L||Standard Deviation|Mean
2776492|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3|||number of fertilized oocytes||Standard Deviation|Mean
2776493|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2|||number of fertilized oocytes||Standard Deviation|Mean
2776494|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1|||number of fertilized oocytes||Standard Deviation|Mean
2776495|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level|||number of fertilized oocytes||Standard Deviation|Mean
2776496|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level|||number of fertilized oocytes||Standard Deviation|Mean
2776497|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level|||number of fertilized oocytes||Standard Deviation|Mean
2776498|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3|||number of fertilized oocytes||Standard Deviation|Mean
2776499|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2|||number of fertilized oocytes||Standard Deviation|Mean
2776500|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1|||number of fertilized oocytes||Standard Deviation|Mean
2776509|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2|||follicles||Standard Deviation|Mean
2776501|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3|||number of oocytes||Standard Deviation|Mean
2776502|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2|||number of oocytes||Standard Deviation|Mean
2776503|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1|||number of oocytes||Standard Deviation|Mean
2776504|NCT00696878|Secondary|Number of Oocytes Retrieved in a Participant Among Entire Study Population|Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa|||number of oocytes||Standard Deviation|Mean
2776505|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3|||follicles||Standard Deviation|Mean
2776506|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2|||follicles||Standard Deviation|Mean
2776507|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1|||follicles||Standard Deviation|Mean
2776508|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3|||follicles||Standard Deviation|Mean
2776651|NCT00696410|Other Pre-specified|Change From Baseline in Serum Superoxide Dismutase|Change from baseline in serum superoxide dismutase after 10 months of zinc acetate in patients with systolic heart failure and compared with a single measure in healthy controls|Baseline (time 0) and 10 months|Specimens from healthy controls were only analyzed at one time frame.|||units per microL||Inter-Quartile Range|Median
2776510|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1|||follicles||Standard Deviation|Mean
2776511|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3|||follicles||Standard Deviation|Mean
2776512|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2|||follicles||Standard Deviation|Mean
2776513|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1|||follicles||Standard Deviation|Mean
2776514|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3|||follicles||Standard Deviation|Mean
2776515|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2|||follicles||Standard Deviation|Mean
2776516|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1|||follicles||Standard Deviation|Mean
2776517|NCT00696878|Secondary|Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG|Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.|Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa and (rec)hCG|||International Unit (IU)||Full Range|Median
2776518|NCT00696878|Primary|Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776519|NCT00696878|Primary|Number of Participants With Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa|||participants|||Number
2776520|NCT00696878|Primary|Number of Participants With AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa|||participants|||Number
2776521|NCT00696878|Primary|Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776522|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776523|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776524|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776525|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa|||participants|||Number
2776526|NCT00696878|Primary|Percentage of Participants With Clinically Relevant Immunogenicity|Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.|Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle|Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing|||percentage of participants|||Number
2776527|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer|Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.|||Percentage of participants|||Number
2776528|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt|Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.|||Percentage of participants|||Number
2776529|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a vital pregnancy.|||Percentage of participants|||Number
2776530|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a clinical pregnancy.|||Percentage of participants|||Number
2777144|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.||Week 12, 24, and 48|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.|||percentage change||95% Confidence Interval|Mean
2776531|NCT00696800|Secondary|Percentage of Gestational Sacs (Implantation Rate)|The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.|Up to 6 weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.|||Percentage of gestational sacs||Standard Deviation|Mean
2776532|NCT00696800|Secondary|Number of Embryos Transferred on Day 3|After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.|||Number of embryos||Standard Deviation|Mean
2776533|NCT00696800|Secondary|Number of Embryos Obtained on Day 3 Categorized by Quality|Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with IVF and/or ICSI, and excludes those who had embryos transferred or cryopreserved before Day 3.|||Number of embryos||Standard Deviation|Mean
2776534|NCT00696800|Secondary|Percentage of Fertilized Oocytes (Fertilization Rate)|The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI|Up to 18 hours after start of fertilization (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.Restricted to participants with IVF and/or ICSI.|||Percentage of fertilized oocytes||Standard Deviation|Mean
2776535|NCT00696800|Secondary|Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)|The number of oocytes used for ICSI was assessed, and categorized based on their quality|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. For participants who had ICSI; but also includes 3 participants whose oocytes were assessed, but ICSI was not performed.|||Number of oocytes||Standard Deviation|Mean
2776536|NCT00696800|Secondary|Number of Cumulus-oocyte-complexes|Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who underwent IVF.|||Number of cumulus-oocyte complexes||Standard Deviation|Mean
2776537|NCT00696800|Secondary|Number of Follicles Categorized by Size on the Day of hCG|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|Day of HCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection and with USS data available.|||Number of follicles||Standard Deviation|Mean
2776538|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 8|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 8 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 8.|||Number of follicles||Standard Deviation|Mean
2776539|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 5|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 5 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 5.|||Number of follicles||Standard Deviation|Mean
2776540|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 1|Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.|On Day 1 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1.|||Number of follicles||Standard Deviation|Mean
2776541|NCT00696800|Secondary|Serum Inhibin-B Levels During Stimulation|Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available.|||pg/mL||Standard Deviation|Mean
2776542|NCT00696800|Secondary|Serum Progesterone (P) Levels During Stimulation|Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available.|||nmol/mL||Standard Deviation|Mean
2776690|NCT00696020|Secondary|Tmax,ss Olodaterol [h]|"Time from last dosing to maximum concentration of Olodaterol in plasma at steady state (tmax,ss) after 4 weeks treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||hours||Full Range|Median
2776544|NCT00696800|Secondary|Serum Luteinizing Hormone (LH) Levels During Stimulation|Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available.|||IU/L||Standard Deviation|Mean
2776545|NCT00696800|Secondary|Serum FSH Levels During Stimulation|Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available.|||IU/L||Standard Deviation|Mean
2776546|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 8 onwards.|From Day 8 to Day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.|||IU||Full Range|Median
2776547|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 1 onwards.|From Day 1 to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.|||IU||Full Range|Median
2776548|NCT00696800|Primary|Mean Number of Oocytes Retrieved|Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.|||Number of oocytes||Standard Deviation|Mean
2776549|NCT00696800|Primary|Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)|An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.|Assessed at least 10 weeks after embryo transfer (up to 1 year)|Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.|||Percentage of participants|||Number
2776550|NCT00696787|Secondary|Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients|The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.|||units on scale||Standard Error|Mean
2776551|NCT00696787|Primary|Change From Baseline on the Numeric Rating Scale (NRS)|The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.|||units on scale||Standard Error|Mean
2776552|NCT00696774|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776553|NCT00696774|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks|The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776616|NCT00696657|Primary|HbA1c|Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.|After 12 weeks of treatment.|The full analysis set included all randomised subjects who had been exposed to at least 1 dose of the trial product (placebo/semaglutide/liraglutide). Four subjects mistakenly received a different treatment instead of the randomised treatment. The randomised treatment was applied regardless of the treatment actually received.|||Percentage (%) of HbA1c||Standard Deviation|Mean
2776554|NCT00696774|Secondary|Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks|A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.|Baseline, 4 Weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776555|NCT00696774|Secondary|Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776556|NCT00696774|Secondary|Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776557|NCT00696774|Secondary|Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776558|NCT00696774|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks|The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776559|NCT00696774|Secondary|Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks|The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776560|NCT00696774|Secondary|Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks|The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776561|NCT00696774|Secondary|Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks|The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776562|NCT00696774|Secondary|Change From Baseline HAMD-17 Maier Subscale at 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776563|NCT00696774|Secondary|Change From Baseline HAMD-17 Core Subscale at 8 Weeks|"The Core subscale (Items 1,2,3,7,8) evaluates core symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776564|NCT00696774|Secondary|Change From Baseline HAMD-17 Total Score at 8 Weeks|The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776565|NCT00696774|Secondary|Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline."|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Percentage of participants||95% Confidence Interval|Number
2776566|NCT00696774|Primary|Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks|"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a >=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 4 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2776567|NCT00696761|Primary|Treatment Efficacy Was Analyzed by Validated Symptom Scores.|Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.|12 month|The population analyzed included participants receiving drug for 12 months|||score||Standard Deviation|Mean
2776568|NCT00696761|Secondary|Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement||3month, 6month, 12month|||||||
2776569|NCT00696761|Primary|Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment|"international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome~Baseline score minus 12-month score"|12months||||score||Standard Deviation|Mean
2776570|NCT00696709|Primary|Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed.|Up to Dose 4 (Up to ~90 days)|The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination.|||Percentage of Participants|||Number
2776571|NCT00696709|Primary|Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card|Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.|Up to ~28 days Postdose 4 (Up to ~118 days)|The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination.|||Percentage of Participants|||Number
2776572|NCT00696709|Primary|Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence > 0% in one or more vaccination groups.|Up to ~28 days Postdose 4 (Up to ~118 days)|The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination.|||Percentage of Participants|||Number
2776573|NCT00696709|Primary|Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence > 0% in one or more vaccination groups.|Up to Day 5 post any vaccination (Up to ~5 days)|The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination.|||Percentage of Participants|||Number
2776574|NCT00696709|Primary|Percentage of Participants With a Serious Adverse Event|A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed.|Up to ~28 days Postdose 4 (Up to ~118 days)|The analysis population included all participants who received at least one dose of vaccine and who had any safety follow-up based on the actual vaccination received. Participants were excluded if they received an incorrect vaccination.|||Percentage of Participants|||Number
2776617|NCT00696618|Secondary|D(Average) at Two Hours|Mean proximal residence distance of radio-signal from anus as measured on SPECT/CT|two hours following dosing of intervention|All participants who received one dose of each intervention and completed all study visits were included in the analysis.|||centimeters||Inter-Quartile Range|Median
2776575|NCT00696709|Secondary|Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA|Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.|Baseline and ~28 days Postdose 4 (~Day 118)|The analysis population included all heat-treated VZV vaccine participants who received all 4 vaccinations and had no protocol deviations; vaccine A, vaccine B, vaccine C and placebo participants were not assessed for this outcome.|||Ratio||95% Confidence Interval|Geometric Mean
2776576|NCT00696709|Primary|Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients|Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.|Baseline and ~28 days Postdose 4 (~Day 118)|The analysis population included all gamma-irradiated VZV vaccine C participants who received all 4 vaccinations and had no protocol deviations; heat-treated VZV vaccine, vaccine A, vaccine B and placebo participants were not assessed for this outcome.|||Ratio||95% Confidence Interval|Geometric Mean
2776577|NCT00696709|Primary|Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients|Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.|Baseline and ~28 days Postdose 4 (~Day 118)|The analysis population included all gamma-irradiated VZV vaccine B participants who received all 4 vaccinations with no protocol deviations; heat-treated VZV vaccine, vaccine A, vaccine C and placebo participants were not assessed for this outcome.|||Ratio||95% Confidence Interval|Geometric Mean
2776578|NCT00696709|Primary|Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients|Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome.|Baseline and ~28 days Postdose 4 (~Day 118)|The analysis population included all gamma-irradiated VZV vaccine A participants who received all 4 vaccinations with no protocol deviations; heat-treated VZV vaccine, vaccine B, vaccine C and placebo participants were not assessed for this outcome.|||Ratio||95% Confidence Interval|Geometric Mean
2776579|NCT00696696|Secondary|Median Overall Survival (mOS)|Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.|up to 2 years|Based on the number of patients treated.|||days||95% Confidence Interval|Median
2776580|NCT00696696|Secondary|Objective Response Rate|The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)).|up to 1 year|Based on the number of patients evaluable for response. The evaluable patients were those patients who received any treatment and had first response assessment followed by at least one confirmatory scan.|||percentage of patients|||Number
2776581|NCT00696696|Primary|4-month Progression Free Survival (PFS) Rate|The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.|4 months|Based on the number of patients treated.|||percentage of patients|||Number
2776582|NCT00696657|Secondary|Percentage of Subjects Developing Anti-semaglutide Antibodies|Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms.|After 12 weeks of treatment|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Percentage (%) of participants|||Number
2776583|NCT00696657|Secondary|Change From Baseline in Calcitonin|Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||ng/L||Standard Deviation|Mean
2776584|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)|Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, >=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
2776585|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)|Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, >=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
2777145|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels||Week 12, 24, and 48|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population.|||percentage change||95% Confidence Interval|Mean
2776586|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)|Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
2776587|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)|Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
2776588|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)|Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
2776589|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)|Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
2776590|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)|Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
2776591|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)|Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
2776592|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)|Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||umol/L||Standard Deviation|Mean
2776593|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)|Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
2776594|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)|Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmol/L||Standard Deviation|Mean
2776595|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)|Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||umol/L||Standard Deviation|Mean
2776618|NCT00696618|Secondary|Radiolabel Area Under the Curve (AUC 0-24 hr)|Percent of radiolabel dose administered was determined by plasma sampling at standardized intervals over 24 hours. AUC was then calculated using the trapezoidal rule and reported as x10 log 7 microcurie-hours/mL|24 hours following each intervention|All participants who received one dose of each intervention and completed all study visits were included in the analysis.|||10 log 7 microcurie-hours/mL||Inter-Quartile Range|Median
2776596|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)|Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||U/L||Standard Deviation|Mean
2776597|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)|Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||U/L||Standard Deviation|Mean
2776598|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)|Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||U/L||Standard Deviation|Mean
2776599|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)|Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||g/L||Standard Deviation|Mean
2776600|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)|Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776601|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)|Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Trillion cells/litre (10^12/L)||Standard Deviation|Mean
2776602|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)|Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776603|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)|Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776604|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)|Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776605|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)|Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776606|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)|Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Gram/litre (g/L)||Standard Deviation|Mean
2776607|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)|Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Litre/litre (L/L)||Standard Deviation|Mean
2776608|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)|Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776609|NCT00696657|Secondary|Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)|Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Billion cells/litre (10^9/L)||Standard Deviation|Mean
2776610|NCT00696657|Secondary|Change From Baseline in Vital Signs (Blood Pressure; DBP)|Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmHg||Standard Deviation|Mean
2776611|NCT00696657|Secondary|Change From Baseline in Vital Signs (Blood Pressure; SBP)|Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||mmHg||Standard Deviation|Mean
2776612|NCT00696657|Secondary|Change From Baseline in Vital Signs (Pulse)|Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.|Week 0, week 12|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Beats/minute||Standard Deviation|Mean
2776613|NCT00696657|Secondary|Change From Baseline in ECG|"A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as week -2, week 12. Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant [NCS] or abnormal clinically significant [CS]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12)."|Week 0, week 12.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Participants|||Count of Participants
2776614|NCT00696657|Secondary|Percentage of Subjects With Hypoglycaemic Episode|The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was <3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was >=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done.|After 12 weeks of treatment|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Percentage (%) of subjects|||Number
2776615|NCT00696657|Secondary|Percentage of Subjects With an Adverse Events|The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.|After 12 weeks of treatment.|The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T|||Percentage (%) of subjects|||Number
2776650|NCT00696410|Other Pre-specified|Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment|Change from baseline in serum myeloperoxidase (MPO) after 10 months of zinc acetate treatment in patients with systolic heart failure and compared with a single measure from healthy controls|Baseline (time 0) and 10 months|Healthy controls only analyzed at one time point|||units per L||Inter-Quartile Range|Median
2776619|NCT00696618|Primary|Mucosal Toxicity Using Histopathology|"Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.~Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention."|One hour following enema exposure|All participants who received one dose of each intervention and completed all study visits were included in the analysis.|||units on a scale|colon biopsies|95% Confidence Interval|Geometric Mean
2776620|NCT00696488|Primary|Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.|Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used|12 weeks||||percentage of prescribed doses||Full Range|Mean
2776621|NCT00696449|Primary|Adherence to Treatment|Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks||||Percent of prescribed doses||Full Range|Median
2776622|NCT00696436|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2776623|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2776624|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2776625|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776626|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776627|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776628|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776629|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776630|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776631|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776632|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776633|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776634|NCT00696436|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776635|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776636|NCT00696436|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2776637|NCT00696423|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after booster vaccination||||subjects|||Number
2776638|NCT00696423|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after booster vaccination||||subjects|||Number
2776639|NCT00696423|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day follow-up period after booster vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose.|||subjects|||Number
2776640|NCT00696423|Secondary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||subjects|||Number
2776641|NCT00696423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Geometric mean concentrations are given in EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2776642|NCT00696423|Secondary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
2776643|NCT00696423|Secondary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
2776644|NCT00696423|Secondary|Anti-PRP Antibody Concentrations|Geometric mean concentrations are given in μg/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||μg/mL||95% Confidence Interval|Geometric Mean
2776645|NCT00696423|Primary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||subjects|||Number
2776646|NCT00696423|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2776647|NCT00696423|Primary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
2776648|NCT00696423|Primary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in international Unit per milliliter (IU/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.|||IU/mL||95% Confidence Interval|Geometric Mean
2776649|NCT00696423|Primary|Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations|Geometric mean concentrations are given in microgram per milliliter (μg/mL).|One month after booster vaccination|Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity.|||μg/mL||95% Confidence Interval|Geometric Mean
2777211|NCT00690378|Secondary|Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit|Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required|4 to 6 weeks post-therapy||||Participants|||Number
2776652|NCT00696410|Other Pre-specified|Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls|Change in PIIINP from baseline after 10 months of Zinc Acetate in patients with systolic heart failure and compared with a single measure in healthy controls|Baseline (time 0) and 10 months|Specimens from healthy controls were only analyzed at one time frame.|||ng/ml||Inter-Quartile Range|Median
2776653|NCT00696410|Secondary|Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure|Change from baseline in serum isoprostane 10 months after Zn Acetate in patients with systolic heart failure and compared with a single measure in healthy subjects|Baseline (time 0) and 10 months|power calculation using prior studies of the above laboratories. For Controls, a single measure was obtained without further followup.|||pg/ml||Inter-Quartile Range|Median
2776654|NCT00696410|Primary|Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls.|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times daily for 10 months. The change from baseline in markers of cardiac collagen turnover (PINP) in patients with systolic heart failure after 10 months of zinc acetate was measured and compared with a single measure from healthy controls.|Baseline (time 0) and after 10 months of Zinc Acetate.|Power was determined using prior studies examining the change in PINP and (separately) PIIINP in heart failure following administration of aldactone. Results below are PINP. For Controls, a single measure was obtained without further followup.|||ng/ml||Inter-Quartile Range|Median
2776655|NCT00696384|Secondary|Number of Participants With Adverse Events in the Double-Blind Baseline Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for SAE. A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Double-blind Baseline/Week 26 to Week 32||||participants|||Number
2776656|NCT00696384|Secondary|Number of Participants With Adverse Events During the Open-Label Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for serious adverse event (SAE). A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Baseline to Week 26||||participants|||Number
2776657|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Systolic Blood Pressure to Week 26|The change from baseline in sitting clinic systolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.|||mmHg||Standard Deviation|Mean
2776658|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Diastolic Blood Pressure to Week 26|The change from baseline in sitting clinic diastolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.|||mmHg||Standard Deviation|Mean
2776659|NCT00696384|Secondary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Systolic Blood Pressure to Week 32|The change in sitting clinic systolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26.. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776660|NCT00696384|Primary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Diastolic Blood Pressure to Week 32|The change in sitting clinic diastolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776661|NCT00696293|Primary|Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks|"The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe).~A larger reduction of the score from baseline to 12 weeks would represent a better outcome"|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2776662|NCT00696293|Primary|Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks|"The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome~Larger reduction between MADRS from baseline to 12 weeks would represent better outcome"|baseline and 12 weeks|description of median change|||units on a scale||Standard Deviation|Mean
2776663|NCT00696241|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2776664|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2776665|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2776666|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776667|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776668|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776669|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776670|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776671|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776672|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776673|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776674|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776675|NCT00696241|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776676|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776677|NCT00696241|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2776678|NCT00696137|Primary|Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.|Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.|3 years||||Participants|||Count of Participants
2776679|NCT00696072|Secondary|Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)|All participants who received at least one dose of study drug were summarized. The participants were analyzed as per the treatment arm to which they were originally randomized.|||participants|||Number
2776680|NCT00696072|Secondary|Median Time to Treatment Failure (TTF) - ITT Population|Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|ITT population: All participants enrolled in the study.|||Months||95% Confidence Interval|Median
2776681|NCT00696072|Secondary|Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population|Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.|At 6 months and at 12 months|ITT population=Includes all participants registered on the study. n= number at risk|||percentage of participants||95% Confidence Interval|Number
2776682|NCT00696072|Secondary|Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib|Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Participants who changed their treatment regimen from single-agent letrozole to letrozole + dasatinib during the study.|||percentage of participants||95% Confidence Interval|Number
2776683|NCT00696072|Secondary|Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population|PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.|Day 1 to Study Completion (approximately 6 years)|ITT population includes all participants enrolled in the study. The participants were analyzed as per the treatment arm to which they were originally randomized.|||months||95% Confidence Interval|Median
2776684|NCT00696072|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression|CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|All treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of study drug were analyzed. The participants are analyzed as per the treatment arm to which they were originally randomized.|||participants|||Number
2776685|NCT00696072|Primary|Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population|CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Evaluable Population was defined as all treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of randomized study drug. Participants presented in the treatment arm to which they were originally randomized.|||participants|||Number
2776686|NCT00696020|Secondary|AUC(0-3h,ss) Tiotropium [pg*h/mL]|Area under the concentration-time curve of Tiotropium at steady state (AUC(0-3h,ss)) from 0 to 3 hours post dosing after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2776687|NCT00696020|Secondary|Tmax,ss Tiotropium [h]|Time from last dosing to maximum concentration of Tiotropium in plasma at steady state (tmax,ss) after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||hours||Full Range|Median
2776688|NCT00696020|Secondary|Cmax,ss Tiotropium [pg/mL]|Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss) after 4 weeks treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2776689|NCT00696020|Secondary|AUC(0-1h,ss) Olodaterol [pg*h/mL]|"Area under the concentration-time curve of Olodaterol in plasma at steady state (AUC(0-1h,ss)) from 0 to 1 hour post dosing after 4 weeks of treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2776691|NCT00696020|Secondary|Cmax,ss Olodaterol [pg/mL]|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss) after 4 weeks of treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK or had insufficient data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2776692|NCT00696020|Secondary|Clinically Significant Anormalities (Laboratory Data); Marked Changes From Baseline for Vital Signs, Notable Change in ECG and New Onset of ECG Abnormalities|"Possible clinically significant anormalities (laboratory data); marked changes from baseline for vital signs, notable change in ECG and new onset of ECG abnormalities. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AEs).~All AEs with an onset after the first dose of study medication up to 21 days after the last dose of study medication were to have been assigned to the Treatment Period."|From first dose up to 21 days after last dose of study medication.|Treated Set.|||participants|||Number
2776693|NCT00696020|Secondary|Patient's Global Rating|"Patient's Global Rating at the end of the 4 week treatment period.~Patients rated their health (respiratory condition) at Day 29 (compared to the day before they commenced treatment with study medication) on a 7-point scale as very much better (1), much better (2), a little better (3), no change (4), a little worse (5), much worse (6), or very much worse (7). The assessment was made prior to pulmonary function testing and all other study procedures. The Patient's Global Rating was also completed before the Physician's Global Evaluation.~The means are adjusted, based on an ANCOVA with terms for treatment, centre (centre random, treatment effect fixed)."|4 weeks|Full Analysis Set.|||units on a patient's global rating score||Standard Error|Least Squares Mean
2776694|NCT00696020|Secondary|Physician's Global Evaluation|"Measured a 8-point scale, from 1 (poor) to 8 (excellent), as judged by the physician, over 4 weeks of treatment.~The physician made a global evaluation at the end of the Baseline Period (Test Day 1) and at each visit thereafter. These assessments were made prior to pulmonary function testing and reflected the physician's opinion of the patient's overall clinical condition. This evaluation was based on the need for concomitant medication, number and severity of COPD exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 week, 2 weeks and 4 weeks|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
2776695|NCT00696020|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day|The means are adjusted, Based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).|Throughout the 4 weeks treatment period|Full Analysis Set.|||occasion(s)||Standard Error|Least Squares Mean
2776696|NCT00696020|Secondary|Weekly Mean Evening PEF [L/Min]|"The patient will record twice daily peak flow measurements using an AM2+ device. The evening measurement will be performed at bedtime.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 weeks treatment period|Full Analysis Set.|||L/min||Standard Error|Mean
2776697|NCT00696020|Secondary|Weekly Mean Pre-dose Morning PEF [L/Min]|"The patient will record twice daily peak flow measurements using an Asthma Monitor®Am2+ (AM2+) device. Morning measurements will be performed immediately upon arising after the patient has cleared out mucus, prior to administration of trial and/or rescue medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 week treatment period|Full Analysis Set.|||L/min||Standard Error|Least Squares Mean
2776698|NCT00696020|Secondary|PEF (Unsupervised) AUC(6-12h) Response [L/Min] After First Administration and 1,2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L/min||Standard Error|Least Squares Mean
2776699|NCT00696020|Secondary|FEV1 (Unsupervised) AUC(6-12h) Response [L] After First Administration and 1,2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776700|NCT00696020|Secondary|FEV1 and PEF (Unsupervised) AUC(0-6h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|AUC(0-6h) for FEV1, and PEF (unsupervised) were not studied because the pertinent information from the unsupervised pulmonary function tests was for the time interval from 9 to 12 hours post-dosing.|After first administration, 1 week, 2 weeks and 4 weeks|Full Analysis Set.||||||
2776701|NCT00696020|Secondary|PEF Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776702|NCT00696020|Secondary|FVC Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FVC (forced vital capacity) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776703|NCT00696020|Secondary|FEV1 Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776704|NCT00696020|Secondary|PEF AUC(0-6h) Response [L] After 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776705|NCT00696020|Secondary|FVC AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FVC (forced vital capacity) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776706|NCT00696020|Secondary|FEV1 AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776707|NCT00696020|Secondary|PEF AUC(0-3h) Response [L/Min] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"PEF (peak expiratory flow rate L/min) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) will be calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.|||L/min||Standard Error|Least Squares Mean
2776708|NCT00696020|Secondary|FVC AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"FVC (forced vital capacity) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776709|NCT00696020|Secondary|FEV1 AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"Response is defined as change from the baseline value. AUC(0-3h) (area under the curve) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776910|NCT00693992|Secondary|Response Rate (RR)|"The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 5 years)||||percentage of participants|||Number
2776710|NCT00696020|Secondary|Trough FVC Response [L] After 1, 2 and 4 Weeks of Treatment|"Trough FVC (forced vital capacity) was defined as the mean of the 2 FVC values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FVC response was defined as the change from baseline in trough FVC. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|Baseline, 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776711|NCT00696020|Secondary|Trough FEV1 Response [L] After 1 and 2 Weeks of Treatment.|"Trough FEV1 (forced expiratory volume in 1 second) was defined as the mean of the 2 FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 15."|Baseline, 1 week and 2 weeks|Full Analysis Set.|||L||Standard Error|Least Squares Mean
2776712|NCT00696020|Primary|Trough FEV1 Response [L] After 4 Weeks of Treatment|"Trough FEV1 (Forced expiratory volume in 1 second) was defined as the mean of the two FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|Baseline and 4 weeks|Full Analysis Set (FAS). The FAS consisted of all patients who received at least 1 dose of study medication and had baseline data (pre-treatment at the end of the 2-week baseline) for at least 1 efficacy endpoint. For this trial all randomized and treated patients were included in the FAS.|||L||Standard Error|Least Squares Mean
2776713|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.|||mmHg||Standard Deviation|Mean
2776714|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.|||mmHg||Standard Deviation|Mean
2776715|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.|||mmHg||Standard Deviation|Mean
2776716|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.|||mmHg||Standard Deviation|Mean
2776717|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.|||participants|||Number
2776718|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.|||participants|||Number
2776719|NCT00695903|Secondary|Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit|Investigator's assessment of clinical response. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8)|Subset of modified intent-to-treat population who completed TOC/Safety visit|||participants|||Number
2776720|NCT00695903|Primary|Number of Participants With Elevated Serum Creatinine|Number of participants with treatment-emergent serum creatinine increases ≥0.5 mg/dL (for patients with a baseline value ≤3.0 mg/dL) or ≥1.0 mg/dL (for patients with a baseline value >3.0 mg/dL) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.|||participants|||Number
2776741|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776721|NCT00695903|Secondary|Number of Participants With Treatment Cure at End of Therapy (EOT) Visit|Investigator's assessment of treatment cure. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively)|Patients who met the continuation criteria (modified intent-to-treat) and had a EOT assessment of clinical outcome.|||participants|||Number
2776722|NCT00695903|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations|Number of participants with treatment-emergent CPK elevations ≥5 x upper limit of normal (≥1,000 U/L) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.|||Participants|||Number
2776723|NCT00695864|Primary|Change in Withdrawal Symptoms With Placebo and With Ondansetron|Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.|Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron|9 participants and 13 independent trials (3 patients had more than 1 distinct withdrawal episode) were analyzed. Of the 14 participants assigned to intervention, 5 were withdrawn from the study and/or analysis.|||Percent change||Standard Error|Mean
2776724|NCT00695669|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
2776725|NCT00695669|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 51-day follow-up period (Days 0-50) after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
2776726|NCT00695669|Secondary|Number of Subjects With Medically Attended Adverse Events (MAEs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
2776727|NCT00695669|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.|||Subjects|||Number
2776728|NCT00695669|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.|||Subjects|||Number
2776729|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.|Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776730|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776795|NCT00695019|Secondary|Change in Serum HCV RNA Concentration|Change in serum HCV RNA concentration (log10 IU) from baseline to week 48|48 weeks|Intent-to-treat population|||log10 IU||Standard Deviation|Log Mean
2776796|NCT00695019|Secondary|Normalization of ALT|Percentage of participants with a normal serum ALT level at the end of the study|48 weeks|Intent-to-treat|||percentage of participants|||Number
2776731|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At 7, 14 and 21 days after the second dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776732|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776733|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776734|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776735|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776736|NCT00695669|Secondary|Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.|At Days 0, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
2776737|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776738|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776739|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776740|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776742|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776743|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776744|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776745|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776746|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776747|NCT00695669|Primary|Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776748|NCT00695669|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||titers||95% Confidence Interval|Geometric Mean
2776749|NCT00695669|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.|||Subjects|||Number
2776750|NCT00695578|Primary|Mean Severity Score|The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe|4 weeks||||units on a scale||Standard Deviation|Mean
2776751|NCT00695565|Secondary|Change in Blood Pressure From Baseline to Week 12|Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment.|Baseline and Week 12|ITT (Intent-to-Treat)|||mmHg||Standard Deviation|Mean
2776752|NCT00695565|Secondary|Clinician Global Impression of Change (CGIC) at Week 12|At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a CGIC score were analyzed.|||percentage of subjects|||Number
2776753|NCT00695565|Secondary|Patient Global Impression of Change (PGIC) at Week 12|At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a PGIC score were analyzed.|||percentage of subjects|||Number
2776797|NCT00695019|Secondary|Sustained Virologic Response Rate|Percentage of participants who remained HCV RNA negative throughout the study|48 weeks|Intent-to-treat|||percentage of participants|||Number
2776754|NCT00695565|Secondary|Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score|The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief).|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2776755|NCT00695565|Secondary|Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2776756|NCT00695565|Secondary|Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2776757|NCT00695565|Secondary|Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)|Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2776758|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain does not interfere and 10 indicates that pain completely interferes with that function, so lower scores represent better outcomes on this scale.~The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2776759|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates No Pain and 10 indicates Pain as bad as you can imagine. The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief)."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2776760|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).|||percentage of subjects|||Number
2776761|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).|||percentage of subjects|||Number
2776762|NCT00695565|Secondary|Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).|||units on a scale||Standard Deviation|Mean
2776763|NCT00695565|Secondary|Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation)|||units on a scale||Standard Deviation|Mean
2776764|NCT00695565|Primary|Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain.~The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was mLOCF (modified Last Observation Carried Forward): LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication (in which case Baseline Observation Carried Forward (BOCF) was used).|||units on a scale||Standard Deviation|Mean
2776765|NCT00695500|Other Pre-specified|BOLD Response to Alcohol Cue|Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral)|fMRI session following 2 weeks of treatment|sample that completed the assessment|||Percent Signal Change||Standard Error|Mean
2776766|NCT00695500|Secondary|Alcohol Urges|"Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.~Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol."|2.5 hr session following 3 weeks of treatment|sample that completed the assessment|||Units on a scale||Standard Error|Mean
2776767|NCT00695500|Primary|Alcohol Consumption|Peak Breath Alcohol Concentration during IV alcohol self-administration|2.5 hr session following 3 weeks of treatment|sample that completed the assessment|||mg/%||Standard Error|Mean
2776768|NCT00695435|Secondary|Tobramycin Tear Concentration Area Under the Curve (AUC)|Trapezoidal AUC was calculated from 2 to 18 minutes.|2 to 18 minutes post administration||||min*ug/mL||Standard Deviation|Mean
2776769|NCT00695435|Primary|Tobramycin Tear Concentration Cmax (Maximum Concentration)|Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.|2, 4, 6, 12, and 18 minutes||||µg/mL||Standard Deviation|Mean
2776770|NCT00695409|Secondary|Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML|Patient receiving the full treatment of RIT/ZBEAM developed therapy induced MDS or AML.|From peripheral stem cell infusion (Day0 ASCT) to onset of therapy induced MDS/AML, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Participants|||Count of Participants
2776771|NCT00695409|Secondary|Time to Platelet Recovery|Platelet recovery was defined as the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions.|From peripheral stem cell infusion (Day0 ASCT) till the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions|6 patients did not receive full treatment so are excluded from the result analysis.|||Days||95% Confidence Interval|Median
2776772|NCT00695409|Secondary|Time to Neutrophil Recovery|Neutrophil recovery was defined as the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.|From peripheral stem cell infusion (Day0 ASCT) till the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.)|6 patients did not receive full treatment so are excluded from the result analysis.|||Days||95% Confidence Interval|Median
2776773|NCT00695409|Secondary|100-Day Treatment-Related Mortality|The cumulative incidence was estimated after taking into account the competing risk of relapse post-ASCT.|From peripheral stem cell infusion (Day0 ASCT) to death due to any couse, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Percentage of Participants (%)||95% Confidence Interval|Number
2776774|NCT00695409|Secondary|Number of Patients With Grade 3-4 Bearman Toxicities.|Toxicities were recorded using the modified Bearman Scale for non-hematologic adverse events.|From initial of study treatment to Day 100 post-ASCT||||Participants|||Count of Participants
2776775|NCT00695409|Secondary|Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT|Responses are assessed using the Revised Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al. 2007). Complete Response (CR) defined as disappearance of all evidence of disease. Partial Response (PR) defined as regression of measurable disease and no new sites.|Up to Day 100 post-ASCT||||Participants|||Count of Participants
2776776|NCT00695409|Secondary|2-Year Cumulative Incidence of Progression|The cumulative incidence was estimated after taking into account the competing risk of early death.|From peripheral stem cell infusion (Day0 ASCT) to date of first observation of progressive disease or relapsed disease, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis|||Percentage of Participants (%)||95% Confidence Interval|Number
2776777|NCT00695409|Secondary|2-Year Overall Survival|Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]|From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Percentage of Participants (%)||95% Confidence Interval|Number
2776778|NCT00695409|Primary|2-Year Progression-Free Survival|Progression-free survival (PFS) was defined as time from peripheral stem cell infusion to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]|From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 years|6 patients did not receive full treatment so are excluded from the result analysis.|||Percentage of Participants (%)||95% Confidence Interval|Number
2776779|NCT00695396|Secondary|Transfusion Dependent|Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.|Approximately 48 weeks|The intent-to-treat (ITT) population.|||participants|||Number
2776780|NCT00695396|Secondary|RBC Transfusion From Day 29 Through the End of Study|incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).|Day 29 through the end of study (approximately 48 weeks)|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.|||participants|||Number
2776781|NCT00695396|Primary|Red Blood Cell (RBC) Transfusion|Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)|Approximately 48 weeks|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.|||participants|||Number
2776782|NCT00695318|Primary|Change From Baseline in Size of Geographic Atrophy||24 months|Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.|||mm3/year||Standard Deviation|Mean
2776783|NCT00695292|Secondary|Efficacy and Safety Analysis Will be Conducted in Patients With Progressive Disease or Irreversible Toxicity on Chemotherapy Alone Who Elect to Receive Sunitinib Alone Until Progressive Disease or Irreversible Toxicity.||18 months|||||||
2776784|NCT00695292|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.|18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.|||percentage of participants||95% Confidence Interval|Number
2776785|NCT00695292|Primary|One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment||18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.|||percentage of participants|||Number
2776786|NCT00695188|Secondary|HAQ (Health Assessment Questionnaire)||16 weeks|||||||
2776787|NCT00695188|Primary|DAS-28 (Disease Activity Score in 28 Joints)|"DAS stands for Disease Activity Score and is a measure of the activity of rheumatoid arthritis. In Europe the DAS is the recognized standard in research and clinical practice.~The following parameters are included in the calculation:~Number of joints tender to the touch (TEN)~Number of swollen joints (SW)~Erythrocyte sedimentation rate (ESR)~Patient assessment of disease activity (VAS; mm)~The DAS-28 is evaluated using a scale:~0 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity > 5.1: severe disease activity"|16 weeks||||Units on a Scale||Standard Deviation|Mean
2776788|NCT00695136|Primary|Change in Percentage of Time That Subjects With Autism Spend in REM Sleep.||1 month (from baseline to 1.25 mg dose)||||percentage of REM sleep||Standard Error|Mean
2776789|NCT00695097|Primary|Change in Biopsy Cell Densities From Baseline to Follow-up|Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.|1 year|5 Rituximab participants and 4 Control participants provided both baseline and follow-up biopsies for analysis. 6 participants withdrew their consent.|||cells/mm^3||Standard Deviation|Mean
2776790|NCT00695019|Post-Hoc|Normalization of Platelets|Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study|48 weeks|Participants with a baseline platelet count below 150 who were evaluable for response at week 48 were included in the analysis|||percentage of participants|||Number
2776791|NCT00695019|Secondary|Change in Fibrotest Score|Change in fibrotest score from baseline to week 48|48 weeks||||units on a scale||Standard Deviation|Mean
2776792|NCT00695019|Secondary|Change in Social Functioning|"Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48~Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities."|48 weeks|Intent-to-treat|||change in score||Standard Deviation|Mean
2776793|NCT00695019|Primary|Relapse Rate|"Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation~Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml."|48 weeks|Intent-to-treat|||percentage of participants|||Number
2776794|NCT00695019|Secondary|Change in Serum ALT|Change in Serum ALT concentration from baseline to week 48|48 weeks|Intent-to-treat|||U/L||Standard Deviation|Mean
2776798|NCT00694707|Secondary|Change From Baseline to Week 6 in the CGI-S Score|The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.|Baseline to Week 6|Intent-to-treat population: All participants who took at least 1 dose of double-blind investigational product and who had at least 1 post-baseline assessment of the primary efficacy parameter, the PANSS total score.|||Units on a scale||Standard Error|Mean
2776799|NCT00694707|Primary|Change From Baseline to Week 6 in the PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 6|Intent-to-treat population: All participants who took at least 1 dose of double-blind investigational product and who had at least 1 post-baseline assessment of the primary efficacy parameter, the PANSS total score.|||Units on a scale||Standard Error|Mean
2776800|NCT00694603|Secondary|Progression-free Survival||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months||||months||95% Confidence Interval|Median
2776801|NCT00694603|Primary|Response Rate by CT Scan Using RECIST Criteria||8 weeks|The trial used a Simon two-stage design, which enrolled 18 pts in the first stage and was to proceed to enroll an additional 28 evaluable patients if 1 or more response was observed in the first group. This design provided a 57% chance of early termination if the true response rate was <3%. PFSand OS were calculated using the Kaplan-Meier method.|||participants|||Number
2776802|NCT00694564|Secondary|Safety|Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.|0, 2 weeks, 1 month, 2 month|||||||
2776803|NCT00694564|Primary|Wong-Baker FACES Pain Rating Scale|We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).|0, 2 weeks, 1 month, 2 months||||units on a scale||Standard Deviation|Mean
2776804|NCT00694551|Secondary|Number of Participants Who Did Not Have PSA Doubling|Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.|||participants|||Number
2776805|NCT00694551|Secondary|Number of Participants With Prostatic Specific Antigen (PSA) Doubling|"Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy.~Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy."|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.|||participants|||Number
2776806|NCT00694551|Primary|Occurrence of Related Adverse Events - Grade 3 or Higher|Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.|Up to 48 months|All participants who received treatment.|||participants|||Number
2776807|NCT00694473|Secondary|Navigator CGM Accuracy by Category|Mean Absolute Relative Difference (MARD) between the Navigator CGM and reference blood glucose values by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)|72 hours|MARD by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)|||percent absolute relative difference||Standard Deviation|Mean
2776808|NCT00694473|Secondary|Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing:|"Percentage of readings in different blood sugar ranges as shown by point of care testing:~< 60 mg/dl 61-120 mg/dl 121-180 mg/dl 181-240 lmg/dl >240 mg/dl"|72 hours||||percentage of readings|||Number
2776809|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl)||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia||||||
2776810|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL)||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.||||||
2776811|NCT00694473|Secondary|Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values|Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values|72 hours||||percent absolute relative difference||Full Range|Mean
2776812|NCT00694473|Secondary|Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl).||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia||||||
2776813|NCT00694473|Primary|Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).||72 hours|This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.||||||
2776911|NCT00693992|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 5 years)||||months||95% Confidence Interval|Median
2776814|NCT00694369|Secondary|Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication|Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.|At 24 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.|||Participants|||Number
2776815|NCT00694369|Primary|Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.|Over the first 6 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.|||Units on a Scale||Standard Error|Least Squares Mean
2776816|NCT00694356|Secondary|Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab|Formation of HAHAs may block efficacy by substantially increasing the clearance of dalotuzumab and limit the possibility of future dalotuzumab therapy. The occurrence of HAHAs in the sera of dalotuzumab treated participants at any of the serum collection times was assessed.|Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2776817|NCT00694356|Secondary|Steady State Volume of Distribution (Vss) of Dalotuzumab|Vss was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2776818|NCT00694356|Secondary|Clearance (CL) of Dalotuzumab|CL of dalotuzumab was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||mL/min/kg||Geometric Coefficient of Variation|Geometric Mean
2776819|NCT00694356|Secondary|Apparent Terminal Half-life (t1/2) of Dalotuzumab|t1/2 was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||h||Geometric Coefficient of Variation|Geometric Mean
2776820|NCT00694356|Secondary|Time to Cmax (Tmax) of Dalotuzumab|Tmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||h||Full Range|Median
2776821|NCT00694356|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab|AUC0-∞ was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2776822|NCT00694356|Secondary|Maximum Plasma Concentration (Cmax) of Dalotuzumab|Cmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.|Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose|The population consisted of all participants who had pharmacokinetic (PK) measurements at Baseline and at least once during treatment.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2776823|NCT00694356|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Up to 71 days|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2776824|NCT00694356|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Up to 30 days after last dose of study treatment (Up to 101 days)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2776912|NCT00693992|Primary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)||||months||95% Confidence Interval|Median
2776825|NCT00694356|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented.|Cycle 1 (Up to 4 weeks)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
2776826|NCT00694304|Secondary|Change From Baseline in SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
2776827|NCT00694304|Secondary|Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment||Baseline and Week 52|FAS; OC|||percentage of patients|||Number
2776828|NCT00694304|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A|||percentage of patients||Standard Deviation|Mean
2776829|NCT00694304|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A|||percentage of patients||Standard Deviation|Mean
2776830|NCT00694304|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
2776831|NCT00694304|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
2776832|NCT00694304|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
2776833|NCT00694304|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)|||units on a scale||Standard Deviation|Mean
2776834|NCT00694304|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
2776835|NCT00694304|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|APTS|||participants|||Number
2776836|NCT00694161|Other Pre-specified|Change From Baseline in 6-Minute Walk Test (6MWT) at Month 3, 6 and 12|6MWT was used to assess the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.. The distance walked in 6 minutes was categorized as: Level 1: <300 meter, Level 2: 300-374.9 meter, Level 3: 375-449.9 meter, Level 4: >=450 meter.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||meters||Standard Deviation|Mean
2776837|NCT00694161|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide(NT-proBNP) Levels at Week 2, 6, Month 3, 6 and 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.|||picogram/mL (pg/mL)||Standard Deviation|Mean
2776838|NCT00694161|Other Pre-specified|Change From Baseline in Troponin I and Troponin T at Week 2, 6, Month 3, 6 and 12|Troponin I and troponin T were the cardiac markers. Troponin I and troponin T were part of the troponin complex, where troponin I was bound to actin in thin myofilaments and troponin T was bound to tropomyosin. Higher level of these markers was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2776848|NCT00694161|Other Pre-specified|24-Hour Average Heart Rate and Maximium/Minimum Heart Rate|Holter monitor was a machine that recorded the heart rhythms. 24-hour average heart rate and maximium/minimum heart rate was recorded using Holter monitoring.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||beats per minute (bpm)||Standard Deviation|Mean
2776839|NCT00694161|Other Pre-specified|Change From Baseline in the Short Form 36 (SF-36) at Month 3, 6 and 12|SF-36 was standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Scores for the 8 domains range from 0-100, where higher scores were better (100=highest level of functioning) and reported as 2 summary scores; Mental Component Score (MCS) and Physical Component Score (PCS). The score for a section was an average of the individual question scores, which were scaled 0-100, where higher scores were better.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints. Data was collected at Month 3 but not statistically summarized as planned.|||Units on a scale||Standard Deviation|Mean
2776840|NCT00694161|Other Pre-specified|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at Month 3, 6 and 12|KCCQ was a 23-item heart failure specific questionnaire quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. Summary scores were scaled to range from 0 to 100, with higher scores representing greater disability.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Units on a scale||Standard Deviation|Mean
2776841|NCT00694161|Other Pre-specified|Number of Participants With Change in Patient Global Assessment (PtGA) at Month 3, 6 and 12|"Participant's overall quality of life was measured by the PtGA. At baseline participants answered to question: in general, how do you feel today? - on a 5-point scale from '1' (excellent) to '5' (poor). At each follow-up visit, participant's answered to question: How do you feel today as compared to when we talked with you at your last clinic visit for this study? on a 7-point scale- '1' markedly improved, '2' moderately improved, '3' mildly improved, '4' unchanged, '5' mildly worsened, '6' moderately worsened, '7' markedly worsened."|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Participants|||Number
2776842|NCT00694161|Other Pre-specified|Number of Participants With Increased Interstitial Markings and Pleural Effusions|Chest x-ray was done to record the presence of increased interstitial markings (a large number of interstitial markings was indicative of abnormality in the lung) and pleural effusion, which was defined as accumulation of fluid between the layers of tissue that line the lungs and chest cavity.|Baseline, Month 6, Month 12|Intent to Treat (ITT) population included all participants who received at least one dose of study medication.|||Participants|||Number
2776843|NCT00694161|Other Pre-specified|Cardiothoracic (CT) Ratio|Cardiothoracic ratio was defined as the transverse diameter of the heart, compared with that of the thoracic cage, used to help determine enlargement of the heart.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication.|||Ratio||Standard Deviation|Mean
2776844|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Week 6, Month 3, 6 and 12|NYHA: classified as 'class I' (participants with cardiac disease but without resulting limitations of physical activity), 'class II' (participants with cardiac disease resulting in slight limitation of physical activity), 'class III' (participants with cardiac disease resulting in marked limitation of physical activity), 'class IV' (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as 'improved' (positive change), 'no change' or 'worsened' (negative change).|Baseline, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Data at Week 6 was collected but was not summarized due to a change in the planned analysis. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Participants|||Number
2776845|NCT00694161|Other Pre-specified|Heart Rate Variability- Percentage of Successive R-R Intervals With Greater Than 50 Msec Difference Between Normal Beats (pNN50)|Holter monitor was a machine that recorded the heart rhythms. The term 'NN' was used in place of 'R-R' when the processed beats are normal beats. The percentage of successive R-R intervals with greater than 50 msec difference between normal beats was derived by dividing NN50 by the total number of NN intervals (pNN50), where NN50 was the number of interval differences of successive NN intervals greater than 50 msec.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of intervals||Standard Deviation|Mean
2776846|NCT00694161|Other Pre-specified|Heart Rate Variability (HRV)- Standard Deviation (SD) Parameters|Holter monitor was a machine that recorded the heart rhythms. HRV time-domain indices were summarized for root-mean-square of successive differences [RMS SD] of the R-R intervals (R-R is the interval between successive Rs in the ECG wave) between normal beats (NN), magid standard deviation (Magid SD) of normal to normal R-R intervals and Kleiger standard deviation of normal to normal R-R intervals (Kleiger SD). The term 'NN' is used in place of 'R-R' when the processed beats are normal beats.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||msec||Standard Deviation|Mean
2776847|NCT00694161|Other Pre-specified|Number of Participants With Complete Heart Block|Complete heart block is the third-degree atrioventricular block in which the impulse generated in the sinoatrial node in the atrium does not propagate to the ventricles.|Baseline, Month 6, Month 12|No summary was prepared for this data as there were no reports of complete heart block.||||||
2777093|NCT00691132|Secondary|Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.|% Difference in ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL while on PEITC compared to while on Placebo ((PEITC - Placebo) / PEITC) x 100%|After 5 days of treatment||||percentage of change in ratio||95% Confidence Interval|Geometric Mean
2776849|NCT00694161|Other Pre-specified|Number of Participants With Atrial Fibrillation/Flutter, Atrial Tachycardia, Non-Sustained Ventricular Tachycardia (NSVT) Beats), Sustained Ventricular Tachycardia (SVT), Sinus Pause at Month 6 and 12|Holter monitor was a machine that recorded the heart rhythms. Holter monitoring abnormalities of atrial fibrillation/flutter (rapid, irregular heart rhythm), atrial tachycardia (rapid cardiac rate), non-sustained ventricular tachycardia (NSVT)<30 beats, sustained ventricular tachycardia (SVT) >=30 beats and sinus pause (transient interruption in the sinus rhythm) were recorded.|Baseline, Month 6, Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).|||Participants|||Number
2776850|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Left Atrial Dimension and 4 Chamber Right Atrial Dimension at Month 6 and 12|Cardiac MRI was done to measure the left and right atrial dimensions which have diagnostic and prognostic significance in cardiology, in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.||||||
2776851|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Interatrial Septal Thickness at Month 6 and 12|Cardiac MRI was done to measure interatrial septal thickness in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.||||||
2776852|NCT00694161|Other Pre-specified|Change From Baseline in Percentage of Left Ventricular Myocardial Mass With Amyloidosis and Left Ventricular Myocardial Mass With Fibrosis/Scar at Month 6 and 12|Cardiac MRI was done to measure percentage of LV myocardial mass with amyloidosis and LV myocardial mass with fibrosis/scar. LV myocardial mass with amyloidosis or fibrosis/scar was calculated from the product of the myocardial volume and specific gravity of heart muscle, in participants with amyloidosis or fibrosis/scar, respectively.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of LVM||Standard Deviation|Mean
2776853|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Cardiac Output and Right Ventricular Cardiac Output at Month 6 and 12|Cardiac MRI was done to measure cardiac output, which was the volume of blood being pumped by the heart, in particular by the left or right ventricle in the time interval of one minute.|Baseline, Month 6, Month 12|MRI data was collected and reported for cardiac output through the measure of stroke volume as given in outcome measure 17.||||||
2776854|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction and Right Ventricular Ejection Fraction at Month 6 and 12|Cardiac MRI was done to measure: left ventricular ejection fraction (LVEF) was the fraction of the EDV that is ejected out of left ventricle with each contraction and right ventricular ejection fraction (RVEF) was the fraction of the EDV that is ejected out of right ventricle with each contraction. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of EDV||Standard Deviation|Mean
2776855|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricle End Diastolic Volume, Left Ventricle End Systolic Volume, Left Ventricle Stroke Volume, Right Ventricle End Diastolic Volume, Right Ventricle End Systolic Volume, Right Ventricle Stroke Volume at Month 6 and 12.|Cardiac MRI was done to measure left ventricle end diastolic volume (LVEDV), left ventricle end systolic volume (LVESV), left ventricle stroke volume (LVSV), right ventricle end diastolic volume (RVEDV), right ventricle end systolic volume (RVESV) and right ventricle stroke volume (RVSV).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||mL||Standard Deviation|Mean
2776856|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass, Mass of Left Ventricular Myocardium With Amyloidosis, Mass of Left Ventricular Myocardium With Fibrosis/Scar and Right Ventricular End Diastolic Mass at Month 6 and 12|Cardiac MRI was done to measure LVM, mass of left ventricular (LV) myocardium with amyloidosis, mass of LV myocardium with fibrosis/scar and right ventricular end diastolic mass (RVEDM).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Gram||Standard Deviation|Mean
2776857|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Anteroseptal, Left Ventricular Inferolateral Wall Thickness and Right Ventricular End Diastolic Free Wall Thickness at Month 6 and 12|Cardiac Magnetic Resonance Imaging (MRI) was done to measure the thickness of left ventricular anteroseptal (LVAS) wall, left ventricular inferolateral (LVIL) wall and right ventricular end diastolic free (RVEDF) wall.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||mm||Standard Deviation|Mean
2776858|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in Valvular Abnormalities at Month 6 and 12|Valvular abnormalities were those abnormalities (thickening or regurgitation) that involved one or more valves of the heart, determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2776859|NCT00694161|Other Pre-specified|Change From Baseline in Pericardial Effusion at Month 6 and 12|Pericardial effusion was the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2777094|NCT00691132|Secondary|Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC||After 5 days of treatment||||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
2776860|NCT00694161|Other Pre-specified|Change From Baseline in Tissue Doppler- Septal and Lateral Velocity at Month 6 and 12|Tissue Doppler used doppler principles to measure the annular velocities at the lateral and septal areas of the mitral annulus. s': systolic velocity during ejection, e': early diastolic mitral annular velocity, a': late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific categories.|||centimeter/second (cm/sec)||Standard Deviation|Mean
2776861|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: Mitral Deceleration Time at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. The mitral deceleration time was the time taken from the maximum E wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||msec||Standard Deviation|Mean
2776862|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: E/A and E/e' Ratio at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e') (E/e') were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Ratio||Standard Deviation|Mean
2776863|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction at Month 6 and 12|Left ventricular ejection fraction (LVEF) was the fraction of the end-diastolic volume (EDV) that is ejected out of left ventricle with each contraction, estimated by echocardiography. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Percentage of EDV||Standard Deviation|Mean
2776864|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6 and 12|LVM was defined as increase in the mass of left ventricle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||Gram||Standard Deviation|Mean
2776865|NCT00694161|Other Pre-specified|Change From Baseline in Echocardiographic (ECHO) Parameters at Month 6 and 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVEDD).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.|||millimeter (mm)||Standard Deviation|Mean
2776866|NCT00694161|Other Pre-specified|Number of Participants Discontinuing From The Study Due to Clinically Significant Clinical or Laboratory Adverse Events (AEs)||Baseline up to Month 12|ITT population included all participants who received at least one dose of study medication.|||Participants|||Number
2776867|NCT00694161|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO:investigator assessed test to assess cardiac function.ECHO abnormality criteria:any/valvular abnormality,pericardial effusion,abnormal regional wall motion,inferior vena cava respiratory variation,posterior left ventricular wall/septal thickness>=13 millimeter(mm),right ventricular thickness>=7mm,ejection fraction <50%, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A)>=2, ratio of 'E'to lateral/septal mitral annular velocity (e') (E/e'prime lateral>15, E/e'prime septal>15), E deceleration time<=150 millisecond(msec),Isovolumic relaxation time<=70msec.|Baseline up to Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).|||Participants|||Number
2776868|NCT00694161|Other Pre-specified|Number of Participants With Greater Than or Equal to (>=) Grade 3 Treatment-Emergent AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.|||Participants|||Number
2776869|NCT00694161|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.|||Participants|||Number
2776913|NCT00693784|Secondary|Roland-Morris Disability Questionnaire|24-item questionnaire with score determined by the number of items checked by the subject. Items assess the effect of back pain on limitations of normal daily activities. Best value = 0 (least disability). Worst value = 24 (most disability). Higher number indicate greater disability.|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks|||Units on a scale||Standard Deviation|Mean
2776870|NCT00694161|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2776871|NCT00694161|Primary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2776872|NCT00694122|Primary|Blood Glucose|Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.|||mmol/l||Standard Deviation|Mean
2776873|NCT00694122|Secondary|Growth Hormone|Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.|||ug/l||Standard Deviation|Mean
2776874|NCT00694122|Secondary|Glucagon|Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.|||mcg/l||Standard Deviation|Mean
2776875|NCT00694122|Secondary|Cortisol|Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.|||nmol/l||Standard Deviation|Mean
2776876|NCT00694122|Secondary|Insulin Dose|NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.|Overnight||||units||Standard Deviation|Mean
2776877|NCT00694122|Primary|Blood Glucose Area Under the Curve (AUC)|Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.|||mg*10hr/dL||Standard Deviation|Mean
2776878|NCT00694109|Secondary|Percent Change From Baseline in Apolipoprotein A-1|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776879|NCT00694109|Secondary|Change From Baseline in C-Reactive Protein|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776880|NCT00694109|Secondary|Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Total VLDL Particles' Size and Chylomicron Particles' Size.|||percent change||95% Confidence Interval|Mean
2776895|NCT00694109|Primary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776881|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Small).|||percent change||95% Confidence Interval|Mean
2776882|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Medium).|||percent change||95% Confidence Interval|Mean
2776883|NCT00694109|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size.|||percent change||95% Confidence Interval|Mean
2776884|NCT00694109|Secondary|Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Intermediate Density Lipoprotein Particles' Size.|||percent change||95% Confidence Interval|Mean
2776885|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Small).|||percent change||95% Confidence Interval|Mean
2776886|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Medium).|||percent change||95% Confidence Interval|Mean
2776887|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).|||percent change||95% Confidence Interval|Mean
2776888|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Very Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Very Small).|||percent change||95% Confidence Interval|Mean
2776889|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Small).|||percent change||95% Confidence Interval|Mean
2776890|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Medium).|||percent change||95% Confidence Interval|Mean
2776891|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).|||percent change||95% Confidence Interval|Mean
2776892|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Total)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).|||percent change||95% Confidence Interval|Mean
2776893|NCT00694109|Secondary|Percent Change From Baseline in Lipoprotein (a)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776894|NCT00694109|Secondary|Percent Change From Baseline in Triglycerides|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776909|NCT00693992|Secondary|Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale|The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.|At 3 months|Patients who completed the EORTC-QLQ-C30 Global Health Subscale at baseline and 3 months were included in this analysis.|||percentage of patients|||Number
2776896|NCT00694109|Primary|Percent Change From Baseline in Total Cholesterol|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776897|NCT00694109|Primary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776898|NCT00694109|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.|||percent change||95% Confidence Interval|Mean
2776899|NCT00694096|Secondary|Overall Survival|The length of time from the start of treatment for a disease that patients are still alive; no time limit was imposed on data collection|2399 days|All patients that received study treatment and PET scans at baseline and follow-up|||days||Full Range|Median
2776900|NCT00694096|Primary|Proliferative Response|Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.|||participants|||Number
2776901|NCT00694096|Primary|Metabolic Response|Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.|||participants|||Number
2776902|NCT00694070|Primary|Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)|Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.|1-2 hours||||participants|||Number
2776903|NCT00694070|Primary|Number of Participants Rated as <= 3 (Success in Using the Program)|"Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:~successful~successful after being referred to user instructions~success with assistance (similar to a customer call)~unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3."|1-2 hours||||Participants|||Number
2776904|NCT00694070|Primary|Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)|"After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.~Very Simple~Simple~Neither simple nor difficult~Difficult~Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3."|1-2 hours|per protocol|||Participants|||Number
2776905|NCT00694018|Primary|The Roland Morris Disability Questionnaire (RDQ) Score|The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability|12 months|The number of participants analyzed is slightly lower than the number who completed the study at 12 months due to item non-response on the final study survey|||units on a scale||Standard Deviation|Mean
2776906|NCT00693992|Other Pre-specified|VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS||Up to 6 weeks|||||||
2776907|NCT00693992|Secondary|Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.|Duration of study (up to 5 years)|189 participants were evaluable for adverse events.|||percentage of participants|||Number
2776908|NCT00693992|Secondary|Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale|The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.|At 3 months|Patients who completed the EORTC LC13 Dyspnea Subscale at baseline and 3 months were included in this analysis.|||percentage of patients|||Number
2776914|NCT00693784|Secondary|Visual Analog Scale for Low-back Pain|"100 mm line anchored on the left with the descriptor No pain (best value = 0 mm) and anchored on the right with the descriptor Worst possible pain (worst value = 100 mm). Lower scores indicate less pain."|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks|||mm||Standard Deviation|Mean
2776915|NCT00693784|Primary|Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)|The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.|104 weeks|All 15 participants available through 26-week primary endpoint. One voluntary withdrawal and 1 lost-to-follow-up between 26-week follow-up and 52-week extended follow-up. One additional voluntary withdrawal and 1 additional lost-to-follow-up between 52-week extended follow-up and 104-week extended follow-up.|||Events|||Number
2776916|NCT00693719|Secondary|Overall Survival|Still alive for a certain period of time after they were diagnosed with or started treatment|Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months||||Days||95% Confidence Interval|Median
2776917|NCT00693719|Primary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months||||Days||Standard Error|Median
2776918|NCT00693706|Primary|Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.|GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold rise||95% Confidence Interval|Geometric Mean
2776919|NCT00693706|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
2776920|NCT00693706|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
2776921|NCT00693706|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2776922|NCT00693706|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2776923|NCT00693706|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 90-day (Days 0-89) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2776924|NCT00693706|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2776925|NCT00693706|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs).|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2777212|NCT00690378|Secondary|Clinical Outcome in CE Patients at the TOC Visit|Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required|5 to 9 days post-therapy||||Participants|||Number
2776926|NCT00693706|Primary|Number of Subjects With Solicited General Symptoms.|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).|||subjects|||Number
2776927|NCT00693706|Primary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).|||subjects|||Number
2776928|NCT00693693|Primary|Adherence to Locoid|Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied|2 weeks||||percentage of days||Standard Deviation|Mean
2776929|NCT00693654|Secondary|VAS of Pruritus|Subject's self assessment of itching based on a 100 mm visual analog scale with 0 being no itching and 10 being most severe itching|Assessed at baseline and 4 weeks, week 4 reported||||units on a scale||Standard Deviation|Mean
2776930|NCT00693654|Primary|Investigator Global Assessment|"Investigator's Global Assessment Disease Severity is based on the following scale:~0 = completely clear: except for possible residual hyper pigmentation~= almost clear: very significant clearance (about 90%)~= Marked improvement: significant improvement (about 75%)~= Moderate improvement: intermediate between slight and marked; representing about 50% improvements~= Slight improvement: some improvement (about 25%); however, significant disease remaining~= No change (moderate to severe disease)~= Worse"|Disease severity assessed at baseline and 4 weeks, week 4 reported||||units on a scale||Standard Deviation|Mean
2776931|NCT00693628|Primary|Reduction in Time to Healing|time to healing in each group|1 year|study was closed due to low enrollment. Data were not collected.||||||
2776932|NCT00693498|Secondary|Median wrCRP Level|wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects|post op day 1 and 2|64 subjects in each group that received blood; all included in the analysis|||mg/dL||Full Range|Median
2776933|NCT00693498|Primary|12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio|plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.|12 hours post-cardiopulmonary bypass|Only data from those subjects receiving transfusions was analyzed as the study intervention was the type of red blood cell and platelet transfusion (washed v. unwashed).|||ratio||Standard Error|Median
2776934|NCT00693485|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment|||Number of Letters Read Correctly||Standard Deviation|Mean
2776935|NCT00693485|Primary|Percentage of Patients With a Visual Field Improvement in the Study Eye|Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment|||Percentage of Patients|||Number
2776936|NCT00693472|Secondary|Part 2: PANSS Total Score at Day 14|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item).|Day 14 of Part 2|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
2776937|NCT00693472|Secondary|Part 2: Mean GCI at Day 14|The GCI was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).|Day 14 of Part 2|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
2776952|NCT00693303|Primary|Evaluation Tool of Children's Handwriting|This criterion-referenced tool measures a child's legibility and speed in grades one through six. The child writes letters and words, numerals, performs near point and far point copying, writes to dictation, and composes a sentence.|8 weeks from start of training||||percent of legible letters||Standard Deviation|Mean
2776953|NCT00693238|Secondary|Disease Control||20 years after end of radiation|||||||
2776954|NCT00693238|Primary|Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.||6 months after the end of radiation therapy||||Participants|||Number
2776938|NCT00693472|Secondary|Part 1: Mean Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score at Day 14|"The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal).~For each item, symptom severity was rated on a 7-point scale, from 0=absent to 6=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 0 to 180 with a higher score indicating greater severity of symptoms. Although the PANSS is traditionally scored with a range of 30-210, with a score of absent = 1 (for each item), for this analysis the range was set from 0-180, with a score of absent = 0 (for each item)."|Day 14 of Part 1|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
2776939|NCT00693472|Secondary|Part 1: Mean Global Clinical Impression at Day 14|Global clinical impression (GCI) was administered to assess whether any deterioration is due to akathisia or uncontrolled psychoses. Score on a scale +2 to -2 (+2 represents much improvement, +1 some improvement, 0 no change, -1 some worsening, and -2 much worsening).|Day 14 of Part 1|Efficacy analysis population was defined as participants who received at least one dose of study drug. The study was terminated early by the sponsor due to lack of enrollment. No formal statistical analysis was done due to the very small sample size in this study.|||Score on a scale||Standard Deviation|Mean
2776940|NCT00693472|Primary|Part 2: Number of Participants Who Were Treatment Failures|Incidence of treatment failure is reported as the number of participants who were treatment failures. A treatment failure is defined as the failure to achieve at least a 1 point reduction from baseline in BAS score at 24 to 26 hours following study treatment. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).|Up to 14 days|Efficacy analysis population was defined as participants who received at least one dose of study drug.|||Participants|||Number
2776941|NCT00693472|Primary|Part 1: Number of Participants With Akathisia|Incidence of akathisia is reported as the number of participants who experienced akathisia. Akathisia is defined as a score of 3 on the Barnes akathisia scale (BAS) for 3 consecutive intervals or an akathisia score (BAS) of ≥4 for any single day, or the use of a rescue medication within 13 days of initiating treatment with haloperidol and preladenant. The BAS is scored as follows: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness are rated on a 4-point scale from 0 - 3 and are summed yielding a total score ranging from 0 (no akathisia) to 9 (severe akathisia).|Up to 13 days|Efficacy analysis population was defined as participants who received at least one dose of study drug.|||Participants|||Number
2776942|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)|"Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)"|Baseline to Week 20|Intent to Treat Population|||score on a scale||Standard Deviation|Mean
2776943|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 20|Intent to Treat Population|||intensity unit||Standard Deviation|Mean
2776944|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 16|Intent to Treat Population|||intensity unit||Standard Deviation|Mean
2776945|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 20|Intent to Treat Population|||percentage of AOI (in pixels)||Standard Deviation|Mean
2776946|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 20|Intent to Treat Population|||Percentage of participants|||Number
2776947|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16|"Overall, how satisfied are you with your eyelashes?~Possible Answers on a 5 point scale as follows:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied"|Baseline to Week 16|Intent to Treat Population|||score on a scale||Standard Deviation|Mean
2776948|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 16|Intent to Treat Population|||percentage of AOI (in pixels)||Standard Deviation|Mean
2776949|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Upper eyelash length technologically measured in millimeters|Baseline to Week 20|Intent to Treat Population|||millimeters||Standard Deviation|Mean
2776950|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Upper eyelash length technologically measured in millimeters|Baseline to Week 16|Intent to Treat Population|||millimeters||Standard Deviation|Mean
2776951|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 16|Intent to Treat Population|||Percentage of participants|||Number
2776955|NCT00693225|Secondary|Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|16 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade D. 14 of the 43 participants in the Omeprazole/sodium bicarbonate PM dose arm were LA Grade D.|||percentage of participants|||Number
2776956|NCT00693225|Secondary|Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|25 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C. 29 of the 43 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C.|||percentage of participants|||Number
2776957|NCT00693225|Primary|Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks||||percentage of patients|||Number
2776958|NCT00693160|Secondary|Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration|Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac|2.5 hours|11 Subjects in the Intrathecal Ketorolac group received post study treatment analysis of CSF for PGE2. We were not able to obtain CSF samples in 3 of the subjects post study drug injection.|||picograms per milliliter||Standard Deviation|Mean
2776959|NCT00693160|Primary|Hyperalgesia|Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament|24 hours||||centimeters^2||Standard Deviation|Mean
2776960|NCT00693017|Secondary|Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures|Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks|||||||
2776961|NCT00693017|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)|||||||
2776962|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase|BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2776963|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2776964|NCT00692913|Secondary|Falls Per Participant|"Number of falls per participant was measured.~The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.~In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the~SPONSOR and served as a guideline to standardize operational procedures for fall adjudication."|Up to Week 52|Intent-to-Treat (ITT) population included all randomized participants within the treatment group to which they were randomized regardless of whether or not a participant may have dropped out in the base or continued into the extension study.|||Number of Falls||Standard Deviation|Mean
2776965|NCT00692913|Secondary|Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density|Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy.|Baseline and Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.|||Percent Change||95% Confidence Interval|Least Squares Mean
2776966|NCT00692913|Secondary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52|"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.|||Percentage of Participants|||Number
2776967|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase|Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2776968|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2776969|NCT00692913|Primary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26|"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 26|"Full Analysis Set Population (FAS) included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were~assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period."|||Percentage of Participants|||Number
2776970|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET|"Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into high and low groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only."|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.|||Days||95% Confidence Interval|Median
2776971|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP|"Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into high and low groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only."|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.|||Days||95% Confidence Interval|Median
2776972|NCT00692770|Other Pre-specified|The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2|"Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into high and low groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only."|At Baseline|Plasma biomarker analysis was done in 858 (77%) of the all enrolled subjects.|||Days||95% Confidence Interval|Median
2776973|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score|The PWB, FWB, SWB and EWB were summed to form the FACT-G total score. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACT-G scores ranged from 0 to 108 and the higher scores represented a better quality of life. The MID for the FACT-G total score was in the range of 6 to 7. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-G score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2776974|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score|The FACT-HEP is a 45 item, self-administered, multi-dimensional, psychometrically sound questionnaire used extensively in oncology clinical trials. FACT-HEP consisted of five subscales: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The PWB, FWB, SWB and EWB were summed to form the FACTGeneral (FACT-G) total score. The FACT-G and HCS scores were summed to form the FACT-HEP total score. FACT-HEP scores ranged from 0 to 180 and the higher scores represented a better quality of life. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The minimally important difference (MID) for the FACT-Hep total score was in the range of 8 to 9. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-HEP score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2776975|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D VAS is a measure that represents health status as a single value. It is a 20-centimetre vertical graduated visual analogue scale with scores that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). The respondent rated his/her current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the EQ-5D VAS. A 3-digit number (including leading zeros) was read off the scale from the point where the respondent's line crossed the scale, which was the EQ-5D VAS score. A change of at least 7 points on the VAS was considered as minimally important. The results on the ANCOVA analysis of time-adjusted AUC for the EQ-5D VAS score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2776976|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D Index is a descriptive system of the following health dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Subjects were asked to choose any one of the 3 response levels for each dimension: no problems, some problems, and severe problems. The 5 health dimensions were summarized into a single score, the EQ-5D Index score which ranged from -0.59 to 1 with higher scores representing better health states (0=death, 1= perfect health, and -0.59=a health state worse than death). A change of at least 0.10 to 0.12 points was considered a minimally important difference using Eastern Cooperative Oncology Group Performance Status as the anchor. The results on the Analysis of covariance of timeadjusted Area under curve for the EQ-5D index score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2776977|NCT00692770|Secondary|Overall Survival (OS)|"OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. NA in the reported data indicates values could not be estimated due to censored data."|From randomization of the first subject until 4 years later.|FAS included participants who were randomized to study treatments.|||Days||95% Confidence Interval|Median
2776978|NCT00692770|Secondary|Time to Recurrence (TTR) by Independent Assessment|"TTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. NA in the reported data indicates values could not be estimated due to censored data."|From randomization up to 4 years or until disease recurrence whichever came first|FAS included participants who were randomized to study treatments.|||Days||95% Confidence Interval|Median
2776979|NCT00692770|Primary|Recurrence Free Survival (RFS) by Independent Assessment|Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.|From randomization up to 4 years or until disease recurrence whichever came first|Full analysis set (FAS) included participants who were randomized to study treatments.|||Days||95% Confidence Interval|Median
2776980|NCT00692692|Primary|Post Surgical Infection|Number of participants with post surgical infection|4 weeks||||Participants|||Count of Participants
2776981|NCT00692692|Primary|Patient Satisfaction With the Procedure||one year from time of operation|study was terminated and 1 year follow up was not done||||||
2776982|NCT00692419|Primary|Change in Pain, Sexual Dysfunction, and Depression Symptoms|The primary outcome of this study is the change in symptom scores during the intervention phase of the study|12 months|change in pain score during intervention period. In adjusted models, we used mixed effects linear regression to compare changes in symptom scores between the two study arms over the duration of the intervention, and to compare symptom scores among individual patients across the observation and intervention phases.|||units on a scale||Standard Error|Mean
2776983|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in Cun following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Median
2776984|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in Cun following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2777024|NCT00692094|Primary|Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.||biweekly throughout the entire study|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2776985|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in AnG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2776986|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in AnG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2776987|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2776988|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2776989|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2776990|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.|||percentage of signal change||Standard Deviation|Mean
2776991|NCT00692341|Secondary|Unbound Maximum Observed Plasma Concentration (Cmaxu)|Cmaxu is the highest measured unbound plasma concentration during the dosing interval.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK concentration population included all participants who were treated and had at least 1 concentration measurement. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2776992|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2776993|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]|AUC (0 - ∞)u = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) for unbound drug. It is obtained from AUCu (0 - t) plus AUCu (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2776994|NCT00692341|Secondary|Unbound Apparent Volume of Distribution (Vzu/F)|Volume of distribution of unbound drug is defined as the theoretical volume in which the total amount of unbound drug would need to be uniformly distributed to produce the desired plasma concentration of unbound drug. Unbound apparent volume of distribution after oral dose (Vzu/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||L||Geometric Coefficient of Variation|Geometric Mean
2777041|NCT00691808|Primary|Number of Subjects Reporting at Least One Adverse Event (AE)|An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.|28 days||||Participants|||Number
2776995|NCT00692341|Secondary|Unbound Apparent Oral Clearance (CLu/F)|Clearance of an unbound drug is a measure of the rate at which an unbound drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2776996|NCT00692341|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2776997|NCT00692341|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2776998|NCT00692341|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2776999|NCT00692341|Secondary|Plasma Elimination Half-life (t1/2)|Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||hr||Standard Deviation|Mean
2777000|NCT00692341|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||hr||Full Range|Median
2777001|NCT00692341|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2777002|NCT00692341|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2777003|NCT00692341|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hours (hrs) post-dose|Pharmacokinetic (PK) concentration population included all participants who were treated and had at least 1 concentration measurement.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2777004|NCT00692237|Secondary|Ejection Fraction (EF) Defined as the Volume of Blood Ejected With Each Beat Was Measured on Cine-Cardiac Magnetic Resonance (CMR) Images Before and After Three Months Treatment With Sildenafil and Placebo (100 mg/Day).|The volume of blood within a ventricle immediately before a contraction is known as the end-diastolic volume; the volume of blood left in a ventricle at the end of contraction is end-systolic volume. The difference between end-diastolic volume and end-systolic volumes is the volume of blood ejected with each beat. Ejection fraction (Ef) is the fraction of the end-diastolic volume that is ejected with each beat; expressed as percentage of EDV. This is a measure of cardiac performance that can be deteriorated in diabetic cardiomyopathy.|0 and + 3 months|"We included in this analysis all the patients that concluded the study (Sildenafil group = 29; Placebo group = 25).~The 4 randomized patients who discontinued, did not perform the second after-treatment CMR evaluation.~Analysis was per protocol."|||Percentage % of volume (delta)||Standard Deviation|Mean
2777005|NCT00692237|Primary|Left Ventricular Torsion Defined as Change in Ventricular Mid-wall Rotation (°) Measured by Cine-Cardiac Magnetic Resonance (CMR) Imaging With Tagging, Before and After Three Months of Treatment With Sildenafil and Placebo (100 mg/Day).|Diabetic cardiomyopathy and hypertrophy are characterized by an increase in cardiac torsion Normal value of rotation are < 12°; in hypertrophic heart such values can raise up to 20-25°. A reduction in left ventricular wall rotation is a sign of improvement after removal of known causes of hypertrophy (for example after surgical repair of aortic stenosis). Based on previous studies a reduction of 3 degrees (°) is considered clinically significant.|0 and + 3 months|An overall sample size of 32 subjects (16 for each group) would thus have given a 90% power to detect the specified minimum detectable difference (3°) at a 2-sided significance level of 0.01; 59 patients were enrolled: 29 randomized to Sildenafil and 25 randomized to Placebo completed the trial. Analysis was per primary efficacy outcome (LV-q).|||Degree angle (delta)||Standard Deviation|Mean
2777006|NCT00692211|Primary|Colorectal Cancer Screening|Completing fecal blood test within 90 days of enrolling|3 months||||participants|||Number
2777007|NCT00692198|Secondary|Dyspnea|Change in dyspnea is measured by change in the St George's Respiratory Questionnaire (SGRQ) total score, follow-up value minus baseline value. The SGRQ total score ranges from 0 to 100, with higher values indicating worse dyspnea. The change in score, follow-up value minus baseline value, ranges from -100 to +100, with higher values indicating increase in dyspnea.|Baseline to 1 year|Patients with both the baseline and 1 year SGRQ total score are included|||units on a scale||Standard Deviation|Mean
2777008|NCT00692198|Secondary|6-minute Walk Distance|Change in distance walked during 6-minute walk test, follow-up value minus baseline value (feet)|Baseline to 1 year|Change in 6 minute walk distance from baseline to 1 year is analyzed for patients with both baseline and 1 year values|||feet||Standard Deviation|Mean
2777009|NCT00692198|Secondary|Development of Severe Resting Desaturation|Severe resting desaturation is defined as resting room air SpO2 <=88%|Baseline to 1 year|Participants completing the 1 year saturation assessment are analyzed|||Participants|||Count of Participants
2777010|NCT00692198|Secondary|Depression|Depression is measured by the change in the Hospital Anxiety and Depression Scale (HADS) depression score, follow-up value minus baseline value. The HADS depression score ranges from 0 to 21 with higher values indicating greater depression. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in depression|Baseline to 1 year|Patients with both baseline and 1 year values are included|||units on a scale||Standard Deviation|Mean
2777011|NCT00692198|Secondary|Anxiety|Anxiety is measured by the change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, follow-up value minus baseline value. The HADS anxiety score ranges from 0 to 21 with higher values indicating greater anxiety. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating increase in anxiety|Baseline to 1 year|Patients with both the baseline and 1 year values are included; a subset of clinics administered the HADS questionnaire.|||units on a scale||Standard Deviation|Mean
2777012|NCT00692198|Secondary|Sleep Quality|Sleep quality is measured by the change in the Pittsburgh Sleep Quality Index total score, follow-up value minus baseline value. The Pittsburgh Sleep Quality Index total score ranges from 0 to 21 with higher values indicating worse sleep quality. The change in score, follow-up minus baseline value, ranges from -21 to +21 with higher values indicating worsening in sleep quality.|Baseline to 1 year|Participants with both the baseline and 1 year values are included|||units on a scale||Standard Deviation|Mean
2777013|NCT00692198|Secondary|General Quality of Life|General quality of life is measured by the change in the physical component summary subscale of the SF-36 quality of life questionnaire, follow-up value minus baseline value. The physical component summary subscale score ranges from 0 to 100 with higher values indicating better physical functioning. The change in score, follow-up minus baseline value, ranges from -100 to +100 with higher values indicating improvement in physical functioning.|Baseline to 1 year|Participants with both the baseline and 1 year values are included; the SF-36 was administered at a subset of clinics|||units on a scale||Standard Deviation|Mean
2777014|NCT00692198|Secondary|Disease-specific Quality of Life|Disease-specific quality of life is measured by the change in the St George's Respiratory Questionnaire total score, follow-up value minus baseline value. The total score ranges from 0 to 100 with lower score indicating fewer respiratory symptoms. Change in score, follow-up minus baseline may range from -100 to +100, with lower values indicating improvement in disease-specific quality of life.|Baseline to 1 year|Participants with both the baseline and 1 year values are included|||units on a scale||Standard Deviation|Mean
2777015|NCT00692198|Secondary|Preference-weighted Health-related Quality of Life|Preference-weighted health-related quality of life is measured by change in the Quality of Well-being Scale total daily score, follow-up value minus baseline value. The total daily score ranges from 0 to 1 with higher score indicating more better quality of life. Death is scored 0. Greater change, follow-up minus baseline, indicates improvement in quality of life compared to baseline. Change scores may range from -1 to +1.|Baseline to 1 year|Participants with both the baseline and 1 year values were included|||units on a scale||Standard Deviation|Mean
2777016|NCT00692198|Secondary|COPD Exacerbation|Rate of all COPD exacerbations|Through study completion. Median follow-up was 11.4 months||||COPD exacerbations per 100 person-years|||Number
2777017|NCT00692198|Secondary|Adherence|Adherence is measured by self-reported hours of home oxygen per day|Through study completion. Median follow-up was 18.4 months.|Patients providing at least 1 self-report are included.|||hours per day of supplemental oxygen||Standard Deviation|Mean
2777018|NCT00692198|Secondary|Health Care Utilization|Health care utilization is measured by the rate of all hospitalizations.|Through study completion. Median follow-up was 18.4 months.||||Hospitalizations per 100 person-years|||Number
2777019|NCT00692198|Secondary|Death|The difference between treatment groups in mortality is assessed with a time-to-event analysis by calculation of the between group hazard ratio for death; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.|Through study completion. Median follow-up was 41.5 months.||||Deaths/100 person-years|||Number
2777020|NCT00692198|Primary|Death or Hospitalization, Whichever Occurs First|The primary outcome event is death or hospitalization, whichever occurs first. The difference between treatment groups on the primary outcome was assessed with a time-to-event analysis by calculation of the between group hazard ratio for the primary composite outcome; the statistical significance of the hazard ratio was determined from the log rank test. The uncertainty in the hazard ratio is expressed in the 95% confidence interval on the hazard ratio.|Through study completion. Median follow-up was 18.4 months.||||Composite events/100 person-years|||Number
2777021|NCT00692185|Secondary|Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale|The Yale Brown Cornell-Eating Disorders Scale was used.This scale assesses severity of preoccupations and rituals. There are 8 questions that can be scored between 0-4 to indicate severity of symptoms, with 0 representing less severe and 4 representing most severe symptoms. The scores were summed, with possible results totaling 0-32.|Measured at Week 8|Individuals with anorexia nervosa|||score on a scale||Standard Deviation|Mean
2777022|NCT00692185|Primary|Weight Gain||Measured at Week 8||||lbs||Standard Deviation|Mean
2777023|NCT00692094|Secondary|Durability and Toxicity Side Effects Questionnaire||1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777025|NCT00692003|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)|Due to early termination of the study by the Sponsor, no formal analyses were conducted.||||||
2777026|NCT00692003|Secondary|Absolute Change From Baseline in 28-day PGTC Seizure Frequency|Absolute Change from Baseline in 28-day PGTC Seizure Frequency was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks|Due to early termination of the study by the Sponsor, no formal analyses were conducted.||||||
2777027|NCT00691938|Secondary|Rate of Hematologic Improvement.|"-Hematologic improvement (HI). Includes the following categories:~Erythroid response: Hemoglobin increase by ≥ 1.5 g/dL over baseline in which the pretreatment hemoglobin is < 11 g/dL or reduction of RBC transfusions of at least 4 RBC transfusions / 8 wk compared with the pretreatment transfusion number in the previous 8 weeks.~Platelet response. Absolute increase of > 30 x 10^9/L for patients starting with 20 x 10^9/L or increase from < 20 x 10^9/L to > 20 x 109/L and by at least 100%~Neutrophil response. At least 100% increase and an absolute increase > 0.5 x 109/L for patients with pretreatment neutrophils < 1.0 x 109/L)"|Up to 12 months||||percentage of participants|||Number
2777028|NCT00691938|Secondary|Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)|Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).|Up to 12 months||||percentage of participants|||Number
2777029|NCT00691938|Secondary|Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|Completion of follow-up (median follow-up was 58 months)||||months||Full Range|Median
2777030|NCT00691938|Secondary|Event-free Survival|Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)||||days||95% Confidence Interval|Median
2777031|NCT00691938|Secondary|Progression-free Survival||Completion of follow-up (median follow-up was 58 months)|Data was not collected for this outcome measure. Progression is very hard to define for MDS and AML and including it as a pre-specified secondary outcome measure in the protocol was an oversight.||||||
2777032|NCT00691938|Secondary|Remission Duration|Defined as the first date that all criteria for CR, CRi or HI are fulfilled to the date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)|Number of participants analyzed include those participants who met the criteria for CR, CRi, or HI.|||days||Full Range|Median
2777033|NCT00691938|Secondary|Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced|Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.|Up to 13 months after start of treatment||||percentage of participants|||Number
2777034|NCT00691938|Secondary|Time to Response|Time to response is defined as the date of the first dose of study drug to the date that all criteria for CR or CRi are fulfilled.|Up to 12 months|Number of participants analyzed are participants that met the criteria for CR or CRi.|||days||Full Range|Median
2777035|NCT00691938|Secondary|Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4|-The FACT-Leu consists of a 27-item compilation of general questions divided into four primary quality of life domains: physical well-being, social/family well being, emotional well-being, and functional well-being along with a 17 item subscale developed specifically for patients with leukemia.|Up to approximately 12 months after start of treatment|Data was not collected for this outcome measure.||||||
2777036|NCT00691938|Secondary|Rate of Cytogenetic Complete Remission (CRc)|Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.|Up to 12 months||||percentage of participants|||Number
2777037|NCT00691938|Primary|Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)|"Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL.~Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.~Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL)."|Up to 12 months||||percentage of participants|||Number
2777038|NCT00691938|Primary|Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine||Completion of Phase I enrollment for MTD (approximately 26 months)|After enrolling all Phase I patients in Dose Levels 1-5b, the maximum tolerated dose was not determined. The Phase II portion of the study used the 5b dose level.|||mg (level 5b dosing schedule)|||Number
2777039|NCT00691808|Primary|Treatment Compliance|Subjects were considered compliant if they had taken >70% of possible doses of the study drug.|End of study||||Percentage of Participants||Standard Deviation|Mean
2777040|NCT00691808|Primary|Number of Subjects Reporting Adverse Events Leading to Withdrawal||28 days||||Participants|||Number
2777042|NCT00691808|Secondary|Change From Baseline in Epworth Sleepiness Scale at Day 28|The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28||||Units on a scale||Standard Deviation|Mean
2777043|NCT00691808|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index at Day 28|The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28||||Units on a scale||Standard Deviation|Mean
2777044|NCT00691808|Secondary|Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28|The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28||||Units on a scale||Standard Deviation|Mean
2777045|NCT00691808|Secondary|Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28|Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.|Day 28||||Number of words||Standard Deviation|Mean
2777046|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||14 to18 days||||Participants|||Number
2777047|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||25 to 27 days||||Participants|||Number
2777048|NCT00691808|Secondary|Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28|The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.|Day 28||||Number of words||Standard Deviation|Mean
2777049|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||≥28 days||||Participants|||Number
2777050|NCT00691808|Secondary|Plasma Concentration||Day 28||||ng/mL||Standard Deviation|Mean
2777051|NCT00691704|Secondary|Duration of Response|The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) [first observation of PR before confirmation] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years||||months||Full Range|Mean
2777052|NCT00691704|Secondary|Time to Progression|Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006).|6 years|Subjects who experienced disease progression.|||months||Full Range|Mean
2777053|NCT00691704|Secondary|Overall Survival|Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years|Subjects who initiated drug therapy. Eleven patients are still alive as of 2/28/14.|||months||Full Range|Mean
2777054|NCT00691704|Secondary|Time to Response|Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 months|Subjects who responded to drug induction therapy.|||months||Full Range|Mean
2777055|NCT00691704|Primary|Progression Free Survival|Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|2 years|Subjects enrolled and able to initiate induction therapy.|||participants|||Number
2777056|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.|14 Days minus baseline||||Percent change||Standard Deviation|Mean
2777057|NCT00691665|Primary|Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline||||Percent change||Standard Deviation|Mean
2777058|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline||||Percent change||Standard Deviation|Mean
2777059|NCT00691665|Primary|Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline||||Percent change||Standard Deviation|Mean
2777060|NCT00691652|Secondary|Identity of the Gene Activated by Clofarabine Therapy by Using Genomic DNA and RNA Array Technology||Twice monthly at standard of care visits for 3 months post last cycle of chemotherapy.|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777061|NCT00691652|Secondary|Whether Response to Clofarabine Alone or in Combination With Rituximab Correlates With Changes in Global Serum DNA Methylation Index||Duration of the study, up to 1 year.|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777062|NCT00691652|Secondary|Whether Clofarabine Acts as an Inhibitor of DNA Methylation Similar to Cladribine by Performing Scientific Correlates||Duration of the study, up to 1 year.|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777063|NCT00691652|Secondary|Determine the Safety and Efficacy of Clofarabine in Combination With Rituximab||Duration of the study, up to 1 year.|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777064|NCT00691652|Secondary|Determine One-year Progression Free Survival Using the MTD of Clofarabine With Rituximab in Relapsed CD20+NHL||One year after study drug(s) have been given. Duration of study up to 1 year.|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777065|NCT00691652|Primary|Estimate Objective Response Rates of Oral Clofarabine in Combination With Rituximab in Relapsed CD20+NHL||Oral Clofarabine x 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777066|NCT00691652|Primary|The Maximum Tolerated Dose (MTD) of Oral Clofarabine in Adult Patients With Relapsed CD20+ Non-Hodgkin Lymphoma(NHL)|"Initially, 3 patients will be enrolled into a dose level during the dose-escalation portion:~If no patient experiences dose-limiting toxicities during the first 4 weeks, then 3 patients will be enrolled into the next dose level.~If one of the three patients develops dose-limiting toxicities, then 3 additional patients will be enrolled in that cohort. If none of the additional 3 patients experiences dose-limiting toxicities, then further dose-escalation occurs.~If one additional patient experiences dose-limiting toxicities, then the maximum tolerated dose is exceeded."|14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days|Insufficient data to analyze outcome. Funding ended when only one subject enrolled and subject withdrew early.||||||
2777067|NCT00691574|Secondary|Wrist Actigraph Activity Levels as a Secondary Indicator of Circadian Phase||every 2-4 weeks throughout the entire study along with every Circadian Phase Marker assessment|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777068|NCT00691574|Secondary|Polysomnography Sleep Disorder Assessment||1 optional, 12-hour assessment towards the end of the study|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777069|NCT00691574|Primary|Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples||every 2-4 weeks throughout the entire study|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777070|NCT00691483|Other Pre-specified|Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12|Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline through Week 5|Number of participants analyzed = participants with FQA through Week 5, excluding 157 participants for whom FTND was not done at the time of FQA (1 participant also had inconsistent FQA date with first dosing date). Analysis done by smoking status at Week 12 (Responder for the primary endpoint of CA Weeks 9-12).|||Units on a scale||Standard Deviation|Mean
2777071|NCT00691483|Secondary|Percentage of Participants With 4-week Point Prevalence of Nonsmoking|Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.|Week 24|"FAS. Missing inventory interview questions of whether the subject had smoked or used any other tobacco products in the last 4 weeks were not imputed. Missing CO was imputed as =<10 ppm."|||Percentage of participants|||Number
2777072|NCT00691483|Secondary|Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)|Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.|Week 12 and Week 24|"FAS. Missing weekly interview questions of whether the subject had smoked in the last 7 days were not imputed; missing CO was imputed as =<10 ppm."|||Percentage of participants|||Number
2777073|NCT00691483|Secondary|Percentage of Participants With Long Term Quit Through Week 24|Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.|Week 9 through Week 24|FAS. If the number of days smoked was missing for a subject visit, the CA responder status of the subject at that visit determined the imputation.|||Percentage of participants|||Number
2777074|NCT00691483|Secondary|Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24|Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.|Week 9 through Week 24|FAS. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.|||Percentage of participants|||Number
2777075|NCT00691483|Primary|Percentage of Participants With 4-week Continuous Abstinence (CA)|The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.|Week 9 through Week 12|Full analysis set (FAS): took at least 1 dose, including partial doses, of randomized study drug. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.|||Percentage of participants|||Number
2777076|NCT00691444|Secondary|Durability and Toxicity Side Effects Questionnaire||1 year|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777077|NCT00691444|Primary|Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.||biweekly throughout the entire study|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777078|NCT00691327|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|5 years|All patients who had a breast implant satisfaction rating|||Units on a scale||Standard Deviation|Mean
2777079|NCT00691327|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|5 years|All enrolled patients|||Percentage by Patient||95% Confidence Interval|Number
2777080|NCT00691301|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years.|Eligible and treated patients|||months||Full Range|Median
2777081|NCT00691301|Secondary|Progression-free Survival|Duration of progression-free survival in months.|From enrollment onto the study until the onset of disease progression or death, up to 5 years|Individuals who initiated study treatment|||months||Inter-Quartile Range|Median
2777082|NCT00691301|Primary|Frequency and Severity of Observed Adverse Effects|All eligible and evaluable patients|every 21 days during study treatment and up to 30 days after the last cycle of treatment.|All eligible and evaluable patients.|||Participants|||Count of Participants
2777083|NCT00691301|Primary|Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.|Individuals who initiated study treatment|||participants|||Number
2777084|NCT00691210|Primary|The Maximum Tolerated Dose of Niacinamide in the Combination of Vorinostat and Niacinamide||3 years|There were no evaluable patients at these levels.|||mg/kg|||Number
2777085|NCT00691210|Secondary|Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies||continuous|||||||
2777086|NCT00691210|Secondary|The Prevalence of Anti-tumor Activity||continuous|||||||
2777087|NCT00691210|Secondary|The Number of Dose Delays and Reductions at the MTD||continuous|||||||
2777088|NCT00691210|Secondary|The Greatest Number of Cycles Received in Each Treatment Group|The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.|up to 45 weeks||||cycles|||Number
2777089|NCT00691197|Post-Hoc|Patient Preference|"Percentage of patients who used pre-study rewetting drops and answered Agree or Strongly Agree when asked if they preferred the study drops (SD) over their pre-study drops(PSD)."|Day 30|Responders Completed Population|||Percentage of participants|||Number
2777090|NCT00691197|Secondary|Corneal Staining|Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding|Day 90|Completed Population|||Participants|||Number
2777091|NCT00691197|Post-Hoc|Patient Acceptability|"A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either Agree or Strongly Agree at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects)"|Day 90|Intent to Treat Population|||Percentage of Participants|||Number
2777092|NCT00691197|Primary|Best Corrected Visual Acuity|Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.|Change from Baseline at Day 90|Completed Population|||Percentage of Participants|||Number
2777095|NCT00691132|Secondary|Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC|Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTT1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.|After 5 days of treatment||||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
2777096|NCT00691132|Secondary|Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC|Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTM1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.|After 5 days of PEITC treatment||||nmol/mg creatinine||95% Confidence Interval|Geometric Mean
2777097|NCT00691132|Primary|Urinary Levels of Biomarkers of NNK Metabolism|The ratio of urinary [pyridine-D4]hydroxy acid : total [pyridine-D4]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.|After 5 days of treatment||||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
2777098|NCT00691132|Primary|Urinary Levels of Biomarkers of NNK Metabolism|Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.|2 periods, 5 days each on PEITC or Placebo, with washout week between||||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
2777099|NCT00691093|Secondary|Reasons for Study Treatment Dose Changes|Possible change in the dose and the reasons for the change were collected and documented.|Month 3 or ET|SAS|||participants|||Number
2777100|NCT00691093|Secondary|Study Doses|Number of subjects that changed doses throughout the study period.|Month 3 or ET|SAS|||participants|||Number
2777101|NCT00691093|Secondary|Time To Onset Of Treatment Response|Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.|Month 1, Month 2, Month 3 or ET|FAS|||weeks||Full Range|Median
2777102|NCT00691093|Secondary|Change From Baseline in Total Scores of OAB-q at Visit 4|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS|||scores on a scale||Standard Deviation|Mean
2777103|NCT00691093|Primary|Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4|The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||episodes||Standard Deviation|Mean
2777104|NCT00691093|Primary|Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4|UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||episodes||Standard Deviation|Mean
2777105|NCT00691093|Primary|Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4|Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||episodes||Standard Deviation|Mean
2777106|NCT00691093|Secondary|Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS|||scores on a scale||Standard Deviation|Mean
2777107|NCT00691093|Secondary|Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4|Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.|Month 3 or ET|FAS|||scores on a scale||Standard Deviation|Mean
2777108|NCT00691093|Secondary|Clinical Global Evaluation of Fesoterodine|Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'|12 weeks|SAS|||participants|||Number
2777109|NCT00691093|Secondary|Patient's Global Evaluation of Fesoterodine|The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.|Baseline, Month 3 or ET|The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.|||participants|||Number
2777110|NCT00691093|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4|The PVR urine volume: measured by an ultrasound scan.|Baseline, Month 1, Month 2, Month 3 or ET|FAS|||ml||Standard Deviation|Mean
2777146|NCT00690898|Secondary|Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).||Baseline (week 1) to week 12 and week 24|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.|||participants|||Number
2777111|NCT00691093|Primary|Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit|Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)|The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.|||episodes||Standard Deviation|Mean
2777112|NCT00691054|Secondary|Median Overall Survival of Participants|Median overall survival rate of participants measured in months|12 months||||months||95% Confidence Interval|Median
2777113|NCT00691054|Secondary|Number of Participants Experiencing Adverse Events||6 months||||Participants|||Count of Participants
2777114|NCT00691054|Secondary|Progression-free Survival|Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months||||months||95% Confidence Interval|Median
2777115|NCT00691054|Secondary|Number of Participants Showing Stable Disease|Number of participants showing stable disease according to RECIST 1.0 criteria|12 months||||participants|||Number
2777116|NCT00691054|Secondary|Number of Participants Showing Complete or Partial Response|Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||participants|||Number
2777117|NCT00691054|Primary|Overall Survival Rate at 6 Months|Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.|6 months||||percentage of participants||95% Confidence Interval|Number
2777118|NCT00691028|Secondary|Pharmacokinetics Positive- ATI|ATI (antibody to Infliximab) was measured by a modification of an enzyme immunoassay.|54 weeks||||participants|||Number
2777119|NCT00691028|Secondary|Pharmacokinetics- Serum Concentration of Infliximab|Serum level of infliximab was measured by enzyme-linked immunosorbent assay (ELISA), using a monoclonal antibody against infliximab. The lowest level of infliximab that could be reliably detected was 0.1 ug/ml.|54 weeks|||||||
2777120|NCT00691028|Secondary|Change in Modified Total Sharp Score (mTSS) at week54 From Baseline|The mTSS is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 54 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 and joint space narrowing on a scale of 0 (no damage) to 4. Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 390 [maximal disease]). An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|baseline and week 54||||score||Inter-Quartile Range|Median
2777121|NCT00691028|Secondary|Change From Baseline to Week 54 in HAQ|HAQ: patient's assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|54 weeks||||units on a scale||Standard Deviation|Mean
2777122|NCT00691028|Secondary|Change From Baseline in DAS28|DAS28 is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Total score range:0 to 9.4, higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 to 9.4 implied high disease activity and <2.6 implied remission.|baseline and week 54||||units on a scale||Standard Deviation|Mean
2777123|NCT00691028|Secondary|CRP Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range of CRP is 0 mg/dL to 0.3 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|54 weeks||||mg/dl||Inter-Quartile Range|Median
2777124|NCT00691028|Secondary|Swollen Joint Count (SJC)|The SJC was determined by examination of 66 joints and identifying when swelling was present. The SJC was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|54 weeks||||count||Standard Deviation|Mean
2777125|NCT00691028|Secondary|Tender Joint Counts (TJC)|The TJC was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The TJC was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|54 weeks||||count||Standard Deviation|Mean
2777126|NCT00691028|Secondary|Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)|ACR 20 (50 or 70) response is a decrease of at least 20% (50% or 70%) in both TJC and SJC and in 3 to 5 assessments (patient's assessment of pain [VAS] with 0, no pain to 100, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 100, very poor and 0, no arthritis activity to 100, extremely active, respectively]; [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; [CRP])|54 weeks||||percentage of participants|||Number
2777142|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
2777127|NCT00691028|Primary|Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)|The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient's assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient's global assessment of disease activity (VAS 0-100); c. Physician's global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.|baseline and week 54||||percent change||Standard Deviation|Mean
2777128|NCT00691015|Secondary|Karnofsky Performance Status Performance Status|"100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment necessary.~10 - Moribund; fatal processes progressing rapidly. 0 - Dead"|At 90 days after PBSCT|All participants|||units on a scale||Full Range|Median
2777129|NCT00691015|Secondary|Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)||Within 6 months after PBSCT|All participants|||percentage of participants||95% Confidence Interval|Number
2777130|NCT00691015|Secondary|Overall Survival.||At 2 years after PBSCT||||percentage of participants||95% Confidence Interval|Number
2777131|NCT00691015|Secondary|Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )||post transplant, up to 4 weeks|All participants|||Days||Full Range|Median
2777132|NCT00691015|Secondary|Incidence of Chronic GVHD.||Within 2 years after PBSCT|All participants|||percentage of participants||95% Confidence Interval|Number
2777133|NCT00691015|Primary|Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.||Within 6 months after PBSCT|All participants|||% of participants with a reported SAE||95% Confidence Interval|Number
2777134|NCT00691015|Primary|Severity of Acute Graft-versus-host Disease (GVHD)||Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria|The patients that contracted sever acute graph versus host disease (aGVHD) from those who developed aGVHD|||% of participants with severe aGVHD||90% Confidence Interval|Number
2777135|NCT00691015|Primary|Incidence of Acute Graft-versus-host Disease (GVHD)||Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria||||percentage of participants||90% Confidence Interval|Number
2777136|NCT00690924|Primary|Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks|"Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.~CTEP Version 4 of the CTCAE is identified and located at:~http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm."|3 months|All treated and eligible patients|||participants|||Number
2777137|NCT00690898|Secondary|Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline|Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||units on a scale||95% Confidence Interval|Mean
2777138|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
2777139|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
2777140|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
2777141|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.|||percentage of subjects|||Number
2777143|NCT00690898|Secondary|Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels||Week 12, 24 and 48|Analysis based on the number (n) of subjects with baseline level between 20 ng/ml and 100 ng/ml in the ITT population with a valid value.|||mcg/L||Standard Deviation|Mean
2777147|NCT00690898|Primary|Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)|A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.|Week 1 and Week 48|Analysis based on intent-to-treat (ITT) population comprised of 89 patients.|||percentage of subjects||95% Confidence Interval|Number
2777148|NCT00690833|Primary|Investigator Global Assessment at Week 4|The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe|Week 4||||units on a scale||Standard Deviation|Mean
2777149|NCT00690820|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
2777150|NCT00690820|Secondary|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
2777151|NCT00690820|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
2777152|NCT00690820|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Number per day||Standard Deviation|Mean
2777153|NCT00690820|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
2777154|NCT00690820|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
2777155|NCT00690820|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
2777156|NCT00690820|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
2777157|NCT00690794|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.|Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.|||percentage of patients|||Number
2777158|NCT00690794|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Baseline, Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.|||Units on a scale||Standard Error|Mean
2777159|NCT00690755|Primary|Alterations in PKC-zeta mRNA in Vastus Lateralis Skeletal Muscles|All muscle samples obtained by 9/30/07, final date for examination of samples 9/30/08 Muscle dependent ability to diminish blood glucose levels during insulin treatment.|PKC-zeta mRNA levels and aPKC activity in muscle evaluated 40 minutes post-insulin treatment|PKC-zeta mRNA and aPKC activity in vastus lateralis skeletal muscle was measured by analysis of gene expression levels of PKC and measuring them in relative amounts in comparison to control subjects.|||arbitrary units/ng rRNA||Standard Error|Mean
2777160|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|every 3 months - baseline to final visit||||mm Hg||Standard Deviation|Mean
2777206|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
2777161|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|Every 3 months- baseline to final visit||||Millimeters of Mercury (mm Hg)||Standard Deviation|Mean
2777162|NCT00690573|Secondary|Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)|Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Week 24 and Week 60||||Participants|||Number
2777163|NCT00690573|Secondary|Mean Serum Adalimumab Concentration|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL).|Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60|For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60.|||mcg/mL||Standard Deviation|Mean
2777164|NCT00690573|Secondary|Number of Subjects Achieving PedACR 30/50/70 Responses||Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit|The analysis was conducted using the full analysis set (FAS) population (all subjects who received at least 1 dose of study drug) as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144.|||Participants|||Number
2777165|NCT00690573|Secondary|Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16|Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. Missing values were treated as non-responders.|||Participants|||Number
2777166|NCT00690573|Primary|Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16|Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug.|||Participants|||Number
2777167|NCT00690495|Secondary|Further Assessment of Injection Pain||during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia|||||||
2777168|NCT00690495|Primary|Incidence of Expression of Pain During Injection||during first propofol bolus|per protocol|||participants|||Number
2777169|NCT00690482|Secondary|Adverse Event|The number of participants that experienced at least one adverse event.|Up to 4 Weeks|The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.|||Participants|||Number
2777170|NCT00690482|Secondary|Total Use of Reliever|Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Number of inhalations per day||Full Range|Mean
2777171|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Evening|Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Full Range|Mean
2777172|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Morning|Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Full Range|Mean
2777173|NCT00690482|Secondary|COPD Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
2777174|NCT00690482|Secondary|COPD Symptom Cough Score|Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
2777207|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
2777175|NCT00690482|Secondary|COPD Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
2777176|NCT00690482|Secondary|COPD Symptom Sleep Score|Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
2777177|NCT00690482|Secondary|FEF25%-75%|Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/s||Full Range|Mean
2777178|NCT00690482|Secondary|Inspiratory Capacity|Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
2777179|NCT00690482|Secondary|Slow Vital Capacity|Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
2777180|NCT00690482|Secondary|Forced Vital Capacity|Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
2777181|NCT00690482|Primary|Clinical COPD Questionnaire|Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
2777182|NCT00690482|Primary|FEV1|Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Full Range|Mean
2777183|NCT00690443|Secondary|Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.||Baseline and 4 weeks||||Percent||Standard Deviation|Mean
2777184|NCT00690443|Primary|Percent Change in LDL-C After 8 Weeks of Therapy||Baseline and 8 weeks of treatment||||Percent Change||Standard Deviation|Mean
2777185|NCT00690430|Secondary|Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
2777186|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
2777187|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
2777188|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
2777189|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria|Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with analyzable data at month 6 were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
2777208|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
2777209|NCT00690378|Secondary|Microbiological Outcome in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
2777210|NCT00690378|Secondary|Microbiological Outcome in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
2777190|NCT00690430|Secondary|Objective Tumor Response Rate Assessed by Investigator|Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization. Patients randomized 6 months before the final clinical cutoff date were included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2777191|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.||||||
2777192|NCT00690430|Secondary|Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients were analyzed according the treatment they were assigned to at randomization. (ITT) principle.|||Percentage of Episodes||Standard Deviation|Mean
2777193|NCT00690430|Secondary|Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients who had symptoms at baseline and at 6 months were included in this analysis.|||Percentage of Episodes||Standard Deviation|Mean
2777194|NCT00690430|Primary|Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.|Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): <4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of <5 flushing episodes. (CBRC) <4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of <4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.|Month 6|The Efficacy analyzable set consists of subset of FAS patients who were randomized at least six months prior to futility interim analysis data cut-off. It is for the primary efficacy analysis and secondary efficacy analysis except for tumor response assessment. Data reported was based on randomized patients at the time of the interim analysis.|||Percentage of Participants||95% Confidence Interval|Number
2777195|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
2777196|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
2777197|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
2777198|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
2777199|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
2777200|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
2777201|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
2777202|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
2777203|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
2777204|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
2777205|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
2777213|NCT00690378|Secondary|Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit|Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required|End of IV therapy (4 to 14 days)||||Participants|||Number
2777214|NCT00690378|Primary|Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|5 to 9 days post-therapy||||Participants|||Number
2777215|NCT00690339|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating|||units on a scale||Standard Deviation|Mean
2777216|NCT00690339|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|10 years||||Percentage of Patients||95% Confidence Interval|Number
2777217|NCT00690274|Secondary|To Evaluate the Effect of BF2.649 on Symptom Severity Between Baseline and Week 12|Montgomery-Asberg Depression Rating Scale (MADRS), a depression rating scale. The score can total from 0-60, with the higher score indicating more severe depressive symptoms. The scores indicate a change between baseline and 12 weeks.|12 weeks||||scores on a scale||Standard Deviation|Mean
2777218|NCT00690274|Primary|Changes in Delayed Recall From Baseline to 12 Weeks|The Brief Visuospatial Memory Test-Revised (Delayed Recall) is a neuropsychological test to assess one's ability to recall a previously exposed stimuli. The t-score range (as being reported) is from 35-81, with higher scores being better and indicating being able to recall more items after a 45-minute delay. (The t-score is a score calculated from the individual score and based on each individual's age group.) The t-scores are then grouped together and reported as a mean with the standard deviation.|12 weeks||||t-score||Standard Deviation|Mean
2777219|NCT00690235|Primary|Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine|Mean Number of Pounds Lost on Pramlintide Over 16 Weeks|16 weeks||||pounds||Standard Deviation|Mean
2777220|NCT00690040|Secondary|To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups||At the end of the study|||||||
2777221|NCT00690040|Primary|Average Time in Hours From Insertion of the Catheter Until Delivery||At the end of the study||||HOURS||Standard Deviation|Mean
2777222|NCT00689936|Secondary|Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base|Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.|From randomization to 24 May 2013|||||||
2777223|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.|Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information|||participants|||Number
2777224|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase|Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population; Includes participants with baseline and postbaseline hemoglobin laboratory test grade information|||participants|||Number
2777225|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase|Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population; includes participants with baseline and postbaseline absolute neutrophil laboratory test grade information|||participants|||Number
2777226|NCT00689936|Secondary|Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase|Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.|Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety Population with baseline and postbaseline CrCl data.|||participants|||Number
2777227|NCT00689936|Secondary|Number of Participants With Adverse Events (AEs) During the Active Treatment Phase|A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.|From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Safety population included all participants who received at least one dose treatment dose of treatment in any arm|||Participants|||Number
2777228|NCT00689936|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) up to last visit completed 25 July 2016|Healthcare Resource Utilization not analyzed.||||||
2777229|NCT00689936|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score|EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777230|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777231|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777232|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777233|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777234|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777235|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777236|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777400|NCT00689078|Primary|Ocular Redness at Day 6|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777237|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population with available data.|||units on a scale||Standard Deviation|Mean
2777238|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777239|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|ITT population includes all participants with available data.|||units on a scale||Standard Deviation|Mean
2777240|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777241|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777242|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777243|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777257|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Treatment Failure (TTF)|TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.|From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.|ITT population includes participants who were randomized, independent of whether they received study treatment or not|||months||95% Confidence Interval|Median
2777244|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777245|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777246|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777247|NCT00689936|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777248|NCT00689936|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.|Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit|Intent to Treat (ITT) population with available data.|||units on a scale||Standard Deviation|Mean
2777249|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a Cytogenetic Risk of Uncertain Risk|||percentage of participants|||Number
2777258|NCT00689936|Secondary|Time to First Response Based on the Investigator Assessment at the Time of Final Analysis|The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.|Participants who had at least a PR.|||months||Full Range|Median
2777405|NCT00689078|Primary|Ocular Itching at Day 6|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777250|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a cytogenetic risk of normal|||percentage of particpants|||Number
2777251|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with a Cytogenetic Risk of Favorable Hyperploidy|||percentage of participants|||Number
2777252|NCT00689936|Secondary|Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.|Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population with Cytogenetic risk of Adverse Risk|||Percentage of participants|||Number
2777253|NCT00689936|Secondary|Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population; Participants with second line AMT.|||percentage of participants|||Number
2777254|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis|Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.|||months||Full Range|Median
2777255|NCT00689936|Secondary|Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)|Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.|From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months|ITT population includes all participants who were randomized, independent of whether they received study treatment or not|||months||95% Confidence Interval|Median
2777256|NCT00689936|Secondary|Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis|TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.|From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.|ITT population includes participants who were randomized, independent of whether they received study treatment or not|||months||95% Confidence Interval|Median
2777441|NCT00688844|Primary|Change From Baseline in Bone Mineral Density (BMD) at 12 Months|Change in bone mineral density (BMD) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 3 participants|||grams/centimeter^2||Standard Deviation|Mean
2777259|NCT00689936|Secondary|Time to First Response Based on the Review by the IRAC|The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|Participants who had at least a PR.|||months||Full Range|Median
2777260|NCT00689936|Secondary|Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis|Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.|Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months|Study participants with at least a PR|||months||95% Confidence Interval|Median
2777261|NCT00689936|Secondary|Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC|Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months|Study participants with at least a PR|||months||95% Confidence Interval|Median
2777262|NCT00689936|Secondary|Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.|||percentage of participants|||Number
2777263|NCT00689936|Secondary|Percentage of Participants With an Objective Response Based on IRAC Review|Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm|ITT population includes all participants who were randomized, independent of whether they received study treatment or not.|||percentage of participants|||Number
2777264|NCT00689936|Secondary|Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)|Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.|From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months|ITT population included all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2777265|NCT00689936|Primary|Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis|PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).|From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months|The intent to treat population included all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2777280|NCT00689728|Secondary|Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state|C-trough is defined as the concentration of LY at the end of the dosing interval at steady state. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the Ctrough values were calculated for each dose group based on simulated data.|Pre-dose, Day 1 through Week 24|All randomized participants with evaluable PK C-trough data.|||Micrograms per Milliliter||Standard Deviation|Mean
2777401|NCT00689078|Primary|Ocular Redness at Baseline (Day 0)|A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777266|NCT00689936|Primary|Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)|PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).|From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.|The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2777267|NCT00689884|Secondary|Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.|Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).|At each stage of pheresis for each enrolled subject for a maximum of 2 years.|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.||||||
2777268|NCT00689884|Primary|Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|2 years|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.||||||
2777269|NCT00689871|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating|||units on a scale||Standard Deviation|Mean
2777270|NCT00689871|Primary|Local Complications|By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts|10 years|all enrolled patients|||percentage by patient||95% Confidence Interval|Number
2777271|NCT00689819|Secondary|Change in Prevalence of PCCD|To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.|Baseline and 1 year||||percentage of participants|||Number
2777272|NCT00689819|Primary|Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life|To evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.|Baseline and 1 year||||mm Hg||95% Confidence Interval|Mean
2777273|NCT00689793|Secondary|Adherence to Treatment.|Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)|4 weeks||||percentage of day||Standard Deviation|Mean
2777274|NCT00689793|Secondary|Response of Iron Supplementation on Mental Disorder|Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment.|baseline and 4 weeks|Number of participant was set according the primary outcome.|||participants|||Number
2777275|NCT00689793|Secondary|Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test|Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.|baseline and 4 weeks||||mLO2/kg/min||Standard Deviation|Mean
2777276|NCT00689793|Secondary|Ferritin Change Before and After 4 Weeks of Treatment/Placebo|Level of ferritin measured 4 weeks after randomization|baseline and 4 weeks||||ng/mL||Standard Deviation|Mean
2777277|NCT00689793|Secondary|Hemoglobin Variation Before and After Treatment vs Placebo|The level of hemoglobin measured 4 weeks after randomization|baseline and 4 weeks|The number of participants was calculated according to the primary outcome.|||g/L||Standard Deviation|Mean
2777278|NCT00689793|Primary|Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.|"The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from no fatigue=0 to very severe fatigue=10."|baseline and 4 weeks|The sample size for randomized volunteers was calculated using a two-sample comparison of means to detect a one point difference in the visual analogical scale (first outcome).|||centimeter||Standard Deviation|Mean
2777279|NCT00689728|Secondary|Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)|T-half life (t1/2, tau) is defined as the apparent steady state elimination within the dosing interval. T-half life was obtained by conducting a simulation consisting of 1000 participants using the study drug regimens (30 and 80 mg, intravenous infusion over 30 minutes, once every 3 weeks). The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the t-half life values were calculated for each dose group based on simulated data.|Pre-dose, Day 1 through Week 24|All randomized participants with evaluable PK t-half life data.|||Days||Standard Deviation|Mean
2777402|NCT00689078|Primary|Ocular Itching at Day 28|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777281|NCT00689728|Secondary|Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16|Serum immunoglobulin measured by Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM) levels.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline serum immunoglobulin assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||gram/Liter||Standard Deviation|Mean
2777282|NCT00689728|Secondary|Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this outcome, total B cells (CD20+CD3- cells) are expressed as the relative percent of lymphocytes. There is no reference range provided for this parameter by the performing laboratory.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CD20 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Lymphocytes||Standard Deviation|Mean
2777283|NCT00689728|Secondary|Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this endpoint, total B cell counts (CD20+CD3- cells) are represented by number of cells per microliter. The reference range for the absolute counts is 43-602 cells per microliter.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CD20 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Cells per Microliter||Standard Deviation|Mean
2777284|NCT00689728|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16|The FACIT Fatigue Score is a brief patient-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline FACIT assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
2777285|NCT00689728|Secondary|Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16|EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28 joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).|16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline EULAR28 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Participants|||Count of Participants
2777286|NCT00689728|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 16|Disease Activity Score (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). It is calculated by using the following formula:DAS28-CRP=0.56 times the square root of(28TJC)+0.28 times the square root of(28SJC)+0.36*natural log (ln)(CRP+1)+0.014*patient global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline DAS28 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
2777287|NCT00689728|Secondary|Percent Change From Baseline in C-reactive Protein (CRP) at Week 16||Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline CRP assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percent Change||Standard Deviation|Mean
2777288|NCT00689728|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The HAQ-DI questionnaire scores the participant's self-perception on the degree of difficulty when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do). The scores for each of the functional areas, which have a range from 0 to 3, are averaged to calculate the functional disability index. Higher scores are associated with greater disability.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline HAQ-DI assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
2777289|NCT00689728|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16|Physician's global assessment of arthritis disease activity using a visual analog scale (VAS) which ranged from 0 to 100 millimeters, where 0 indicates no arthritis activity and 100 indicates extremely active arthritis.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline physician's disease activity assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Millimeters||Standard Deviation|Mean
2777290|NCT00689728|Secondary|Change From Baseline in Participant's Assessment of Disease Activity at Week 16|Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline disease activity assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Millimeters||Standard Deviation|Mean
2777291|NCT00689728|Secondary|Change From Baseline in Participant's Assessment of Joint Pain at Week 16|Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline joint pain assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Millimeters||Standard Deviation|Mean
2777292|NCT00689728|Secondary|Change From Baseline in Swollen Joint Count at Week 16|The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline swollen joint assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Swollen Joints||Standard Deviation|Mean
2777293|NCT00689728|Secondary|Change From Baseline in Tender Joint Count at Week 16|The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline tender joint assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Tender Joints||Standard Deviation|Mean
2777294|NCT00689728|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR70 Responder is defined as a participant with at least 70% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|16 weeks|Non-responder imputation (NRI)/last observation carried forward; intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR70 assessment. Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Participants|||Number
2777295|NCT00689728|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as a participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|16 weeks|Non-responder imputation (NRI)/last observation carried forward; intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR20 assessment. Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Participants|||Number
2777296|NCT00689728|Secondary|Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16|Self-reported questionnaire of 36 questions in 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health). Each domain is scored by summing individual items and transforming scores into a 0-100 scale (higher scores=better health status/function). The mental and physical component summaries are based on the 8 domains. Component scores are transformed scores representing a mean (50) and standard deviation (10) in the general United States (US) population. Scores > or <50 are above or below the average US population.|Baseline, 16 weeks|Intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline SF-36 assessment; last observation carried forward (LOCF). Two participants from sites with good clinical practice [GCP] violations are excluded.|||Units on a Scale||Standard Deviation|Mean
2777297|NCT00689728|Secondary|Number of Participants Experiencing An Adverse Event|Serious adverse events and other non-serious adverse events are located in the Reported Adverse Event section.|Baseline up to 68 weeks|Safety population defined as all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2777317|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
2777442|NCT00688844|Primary|Change From Baseline in BMI at 12 Months|Change in Body mass index (BMI) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 2 participants|||kg/m^2||Standard Deviation|Mean
2777298|NCT00689728|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|16 weeks|Non-responder imputation/last observation carried forward (NRI/LOCF); intention to treat (ITT) population defined as participants who were randomized, received at least one dose of study drug, and had at least one post-baseline ACR50 assessment. Two participants from sites with good clinical practice [GCP] violations are excluded.|||Percentage of Participants|||Number
2777299|NCT00689611|Secondary|Composite Major Adverse Cardiovascular Events (MACE)|"All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.~Composite MACE (death, myocardial infarction, unstable angina)"|12 months||||percentage of participants|||Number
2777300|NCT00689611|Primary|Smoking Abstinence|"The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.~The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials."|12 months||||percentage of participants|||Number
2777301|NCT00689481|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 Weeks|ITT|||participants|||Number
2777302|NCT00689481|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 Weeks|ITT|||participants|||Number
2777303|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 Weeks|ITT|||participants|||Number
2777304|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 Weeks|ITT|||participants|||Number
2777305|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 Weeks|ITT|||participants|||Number
2777306|NCT00689481|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population|||participants|||Number
2777307|NCT00689390|Primary|Number of Participants That Discontinued the LTFU Due to SAEs|An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.|||participants|||Number
2777308|NCT00689390|Primary|Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU|Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.|||participants|||Number
2777309|NCT00689390|Primary|Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci|Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS).|From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)|All participants with TE-RAVs who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies (i.e. none of the participants in the narlaprevir study had a TE-RAV).|||participants|||Number
2777310|NCT00689390|Primary|Kaplan-Meier Exposure-adjusted Relapse Rate|The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year].|From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.|||relapses per 1,000 person-years|||Number
2777311|NCT00689390|Primary|Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response)|Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU.|From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.|||participants|||Number
2777312|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
2777313|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
2777314|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
2777315|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.|||percentage of participants|||Number
2777316|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
2777403|NCT00689078|Primary|Ocular Itching at Day 27|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777443|NCT00688753|Secondary|Incidence of Adverse Events, Serious Adverse Events, and Death.||End of trial|Safety Set|||% participants|||Number
2777318|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
2777319|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.|||percentage of participants|||Number
2777320|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the Toddler Dose (13 months of age)|Evaluable Toddler Immunogenicity Population|||Mcg/mL||95% Confidence Interval|Geometric Mean
2777321|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity Population|||Mcg/mL||95% Confidence Interval|Geometric Mean
2777322|NCT00689351|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations|||percentage of participants||95% Confidence Interval|Number
2777323|NCT00689351|Primary|Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.|||percentage of participants||95% Confidence Interval|Number
2777324|NCT00689338|Secondary|Time to Successful Intensive Care Unit (ICU) Discharge|Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.|Day 1 up to Day 56|MITT. N = participants who had a successful ICU discharge.|||days||95% Confidence Interval|Mean
2777325|NCT00689338|Secondary|Day 90 Survival|Percentage of participants known or assumed to be alive on Day 90.|Day 90|MITT|||percentage of participants||95% Confidence Interval|Number
2777326|NCT00689338|Secondary|Time to First Negative Blood Culture|Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.|Day 1 up to Day 42|MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT.|||days||95% Confidence Interval|Mean
2777327|NCT00689338|Secondary|Percentage of Participants With Global Response Success 6 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)|MITT; N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
2777404|NCT00689078|Primary|Ocular Itching at Day 7|Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777444|NCT00688753|Secondary|Median Progression Free Survival|PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.|End of trial||||days||95% Confidence Interval|Median
2777328|NCT00689338|Secondary|Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)|MITT; N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
2777329|NCT00689338|Secondary|Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|EOIVT (Day 10 up to Day 42)|MITT; N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
2777330|NCT00689338|Primary|Percentage of Participants With Global Treatment Response Success at End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|End of Treatment (Day 14 to Day 56)|Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses.|||percentage of participants||95% Confidence Interval|Number
2777331|NCT00689299|Primary|Scores on a Scale (Average of Total Symptom Scores)|"Sum of individual symptoms scores, 7 items, 21 points maximum~Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat.~Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures."|20 weeks|Modified Intent to Treat. All subjects with at least 1 symptom assessment during post treatment chamber exposure|||Scores on a scale||Standard Deviation|Mean
2777332|NCT00689260|Secondary|Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.|||Participants|||Number
2777333|NCT00689260|Secondary|Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.|||Participants|||Number
2777334|NCT00689260|Secondary|Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the Easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.|||Participants|||Number
2777335|NCT00689260|Primary|Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. Seven subjects who had damaged devices or incorrect device setting were excluded from this analysis set.|||Percent of injections missed||Full Range|Median
2777336|NCT00689221|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Up to 50 months|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section.||||||
2777337|NCT00689221|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
2777370|NCT00689104|Secondary|Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
2777338|NCT00689221|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
2777339|NCT00689221|Secondary|Number of Participants With Change From Baseline in Work Status at End of Study|Number of participants with change from baseline in work status (working full time [FT], part-time [PT], unemployed/retired [U/R]) at end of study (EOS) (up to cut-off date, [19 Nov 2012]) was reported. For the category 'part-time', the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3).|Baseline, End of study (up to cut-off date, [19 Nov 2012])|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||participants|||Number
2777340|NCT00689221|Secondary|EuroQol 5-Dimensions (EQ-5D) Questionnaire Index|The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health).|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2777341|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores|The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale ('1=not at all', '2=a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.|||units on a scale||Standard Deviation|Mean
2777342|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores|The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.|||units on a scale||Standard Deviation|Mean
2777343|NCT00689221|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose|The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hour*ng/mL||Standard Deviation|Mean
2777344|NCT00689221|Secondary|Time to Maximum Plasma Concentration (Tmax)|The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."|||hours||Standard Deviation|Mean
2777345|NCT00689221|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2777393|NCT00689091|Secondary|Overall Use of Anesthetics Comparing the BIS to MAC Alerts.||During surgery (45 minutes - 18 hours)||||mg||Inter-Quartile Range|Median
2777394|NCT00689091|Secondary|Percentage of Cases With Electronic Alerts||During surgery: (45 minutes - 18 hours)||||Percentage of cases||Standard Deviation|Mean
2777346|NCT00689221|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|"The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator's assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging.~Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion"|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2777347|NCT00689221|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2777348|NCT00689117|Secondary|The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12|"The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion."|Week 12|ITT Population|||percentage of participants|||Number
2777349|NCT00689117|Secondary|The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12|The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.|Week 12|ITT Population|||participants|||Number
2777350|NCT00689117|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|ITT Population|||percent change||Standard Deviation|Mean
2777351|NCT00689117|Primary|The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|"The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value."|Baseline, Week 12|ITT Population|||percentage of participants|||Number
2777352|NCT00689117|Primary|Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.|||lesions||Standard Deviation|Mean
2777353|NCT00689104|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
2777354|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
2777355|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2777356|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2777357|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Deviation|Mean
2777358|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777359|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777360|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777361|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777362|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777395|NCT00689091|Secondary|Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring|Binary variables for whether participants recall dreaming or not.|During surgery (45 minutes - 18 hours), measured based on 30 day interviews||||Participants|||Count of Participants
2777396|NCT00689091|Primary|The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups.|By modified intention-to-treat analysis|Outcome of awareness is assessed 30-days after the operation||||Percentage of participants/30days||95% Confidence Interval|Number
2777363|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percent activity impairment||Standard Deviation|Mean
2777364|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent overall work impairment||Standard Deviation|Mean
2777365|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent impairment while working||Standard Deviation|Mean
2777366|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent work time missed||Standard Deviation|Mean
2777367|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||Scores on a scale||Standard Error|Least Squares Mean
2777368|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||Scores on a scale||Standard Error|Least Squares Mean
2777369|NCT00689104|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
2777397|NCT00689078|Primary|Ocular Redness at Day 28|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777371|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||pads||Standard Error|Least Squares Mean
2777372|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||nocturia episodes||Standard Error|Least Squares Mean
2777373|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||Scores on a scale||Standard Error|Least Squares Mean
2777374|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Urgency episodes||Standard Error|Least Squares Mean
2777375|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.|||Urgency incontinence episodes||Standard Error|Least Squares Mean
2777376|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.|||mL||Standard Error|Least Squares Mean
2777377|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.|||micturitions||Standard Error|Least Squares Mean
2777398|NCT00689078|Primary|Ocular Redness at Day 27|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777399|NCT00689078|Primary|Ocular Redness at Day 7|Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777378|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
2777379|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.|||micturitions||Standard Error|Least Squares Mean
2777380|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
2777381|NCT00689104|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||mL||Standard Error|Least Squares Mean
2777382|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||micturitions||Standard Error|Least Squares Mean
2777383|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (final visit)|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
2777384|NCT00689091|Other Pre-specified|Incidence of Post-traumatic Stress Disorder.||NEED VALUE HERE|||||||
2777385|NCT00689091|Other Pre-specified|Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University.||Outcome of awareness is assessed|||||||
2777386|NCT00689091|Other Pre-specified|Anesthetic Induction Doses, Hypotension, and BIS Values.||Outcome of hypotension in relationship to induction doses and BIS values will be assessed|||||||
2777387|NCT00689091|Other Pre-specified|Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event.||Outcome of post-traumatic stress disorder is assessed with the covariate of awareness|||||||
2777388|NCT00689091|Other Pre-specified|The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality.||Outcome of mortality is assessed|||||||
2777389|NCT00689091|Other Pre-specified|Relationship Between BIS Values and Hemodynamic Parameters.||Outcome of hemodynamic stability is assessed|||||||
2777390|NCT00689091|Secondary|Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence.|There is controversy regarding the appropriate technique for assessing awareness during anesthesia with explicit recall. A total cohort was utilized to compare the incidence of awareness with recall as determined by formal interview vs. the incidence of awareness with recall based on spontaneous reports (in the same cohort).|30 days after surgery||||participants|||Number
2777391|NCT00689091|Secondary|Number of Participants Without Nausea or Vomiting||During recovery room stay: 30 minutes to 6 hours|Nausea and vomiting numbers were dependent on nurse reporting; as not all nurses did, the participants analyzed are fewer than the total number in the study.|||Participants|||Count of Participants
2777392|NCT00689091|Secondary|Time Till Discharge Readiness|measured in time within Post Anesthesia Care Unit ( PACU) until the participant is ready for discharge from PACU based on a composite of factors, including pain and neurologic status|During recovery room stay: 30 minutes to 6 hours||||minutes||Inter-Quartile Range|Median
2777406|NCT00689078|Primary|Ocular Itching at Baseline (Day 0)|A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2777407|NCT00689052|Secondary|Change From Baseline in Mean Tender Point Threshold|The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777408|NCT00689052|Secondary|Frequency of Rescue Medication for Pain|Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.|Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777409|NCT00689052|Secondary|Clinical Global Impression of Severity (CGI-S Scores)|Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777410|NCT00689052|Secondary|Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)|The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777411|NCT00689052|Secondary|Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)|The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777412|NCT00689052|Secondary|Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)|The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient's health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777413|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .~SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).~Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.~Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777414|NCT00689052|Secondary|Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).|The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777415|NCT00689052|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)|"FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week.~The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777416|NCT00689052|Secondary|The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale|11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777445|NCT00688753|Secondary|Duration of Response|The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.|End of trial|In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria|||days||95% Confidence Interval|Median
2777417|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .~SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).~Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.~Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777418|NCT00689052|Secondary|"The Proportion of Patients Very Much Improved or Much Improved on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale"|"PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment.~The score ranges from 1 = very much improved to 7 = very much worse"|Week 29 (at the end of the maintenance phase)|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777419|NCT00689052|Primary|The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale|The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))||||||
2777420|NCT00689026|Primary|The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.|The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.|The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours|13 patients were excluded from the Experimental Arm (12 cancelled their appointment and 1 did not complete the prep) and 6 were excluded from the Control Arm (5 cancelled their procedure and 1 withdrew from the trial) therefore results were analyzed and compared using the chi-square statistics-Validated Aronchik colonoscopy cleansing grading scale.|||percentage of patients|||Number
2777421|NCT00688935|Secondary|Polysomnography (Sleep Assessment)||1 12-hour assessment any time during the study|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777422|NCT00688935|Primary|Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.||every 2-4 weeks throughout the entire study|The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2777423|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
2777424|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
2777425|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
2777426|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 months of age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2777427|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
2777446|NCT00688753|Secondary|Objective Response Rate|ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression|End of trial||||% participants||90% Confidence Interval|Number
2777428|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
2777429|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 Days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||percentage of participants|||Number
2777430|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 Months of Age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2777431|NCT00688870|Other Pre-specified|GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
2777432|NCT00688870|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
2777433|NCT00688870|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2777434|NCT00688870|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2777435|NCT00688844|Other Pre-specified|Change From Baseline in Serotonin at 12 Months|Objective: 1 year prospective cohort of PKU patients introduced to sapropterin (Kuvan)to evaluate peripheral neurotransmitter changes across time.|Baseline and 12 months|||||||
2777436|NCT00688844|Primary|Change From Baseline in Phenylalanine Intake at 12 Months|Total dietary phenylalanine assessed through 3-day food records - calculated as average phenylalanine intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.|||grams per day||Standard Deviation|Mean
2777437|NCT00688844|Primary|Change From Baseline in Total Dietary Protein Intake at 12 Months|Total dietary protein intake assessed through 3-day food records - calculated as average protein intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.|||grams per day||Standard Deviation|Mean
2777438|NCT00688844|Primary|Change From Baseline in Plasma Phenylalanine at 12 Months|Full amino acid panel, including phenylalanine, analyzed in fasting plasma samples.|Baseline and 12 months||||Micromoles per liter||Standard Deviation|Mean
2777439|NCT00688844|Primary|Change From Baseline in Percent (%) Fat Mass at 12 Months|Percent fat mass measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants|||Percent Fat Mass||Standard Deviation|Mean
2777440|NCT00688844|Primary|Change From Baseline in Percent (%) Lean Mass at 12 Months|% lean mass was measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants|||Percent Lean Mass||Standard Deviation|Mean
2777448|NCT00688753|Primary|To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.|PFSR at 6 months based on central review|6 mos|PP, PPFF, ITT|||% participants||80% Confidence Interval|Number
2777449|NCT00688740|Secondary|Number of Participants With Second Primary Malignancies (Toxicity)|Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.|up to 10 year follow-up||||Participants|||Number
2777450|NCT00688740|Secondary|Number of Participants With Overall Survival Events|Overall Survival - time from the date of randomization up to the date of death of any cause.|up to 10 year follow-up||||Participants|||Number
2777451|NCT00688740|Primary|Number of Participants With Disease-Free Survival Events|Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.|up to 10 year follow-up|The study was originally designed to have 90% power to detect a 26% risk reduction of relapsing for TAC compared to FAC (hazard ratio=0.74)|||Participants|||Number
2777452|NCT00688701|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
2777453|NCT00688701|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2777454|NCT00688701|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 12|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2777455|NCT00688701|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period|Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: >270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: >240 mg/dL (13.3 mmol/L). For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 12|mITT population.|||percentage of participants|||Number
2777456|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2777457|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2777458|NCT00688701|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2777500|NCT00688623|Secondary|Percentage of Participants With Disease Control Rate (DCR) at 12 Months for Per Protocol (PP) and ITT Sets|DCR was based on central radiologic review and is defined as the percentage of patients with a best overall response of 'Complete response' (CR), 'Partial response' (PR) or 'Stable disease' (SD). Relative frequencies together with their exact 2-sided 80% confidence intervals were presented|baseline up to approximately 12 months|subjects who met required criteria|||percentage of participants||80% Confidence Interval|Number
2777459|NCT00688701|Secondary|Change From Baseline in Body Weight at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
2777460|NCT00688701|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2777461|NCT00688701|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2777462|NCT00688688|Secondary|Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram|"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.~The data reported represent the number of participants with adverse events in each category."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.|||participants|||Number
2777463|NCT00688688|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
2777464|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
2777465|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Deviation|Mean
2777466|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777467|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777468|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777469|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777470|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2777471|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline value. LOCF was used for the Final Visit analysis.|||Percent activity impairment||Standard Deviation|Mean
2777472|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||Percent overall work impairment||Standard Deviation|Mean
2777473|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||Percent impairment while working||Standard Deviation|Mean
2777636|NCT00687531|Secondary|Patient's Assessment of Response to Therapy Based on a 5-point Scale|A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.||||||
2777474|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||Percent work time missed||Standard Deviation|Mean
2777475|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
2777476|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
2777477|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
2777478|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||scores on a scale||Standard Error|Least Squares Mean
2777479|NCT00688688|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
2777480|NCT00688688|Secondary|Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
2777501|NCT00688623|Primary|Percentage of Participants With Objective Response Rate at 12 Months ITT Set|Overall Response Rate (ORR) was presented for ITT population as sensitivity analysis. It was presented with relative frequencies and the exact 2-sided 80% confidence limit (CL; computed using the Clopper-Pearson method). If the lower limit of the CI did not include p0=5%, the hypothesis that p ≤ 5% was rejected.|baseline up to approximately 12 months||||percentage of participants||80% Confidence Interval|Number
2778226|NCT00683696|Secondary|Number of Subjects With All-cause Mortality|Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.|From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years||||Participants|||Count of Participants
2777481|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||nocturia episodes||Standard Error|Least Squares Mean
2777482|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit|||pads||Standard Error|Least Squares Mean
2777483|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency|Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis.|||scores on a scale||Standard Error|Least Squares Mean
2777484|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||urgency episodes||Standard Error|Least Squares Mean
2777485|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2777486|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.|||mL||Standard Error|Least Squares Mean
2777487|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.|||incontinence episodes||Standard Error|Least Squares Mean
2777728|NCT00686920|Primary|Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event|A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Month 36|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2777488|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.|||micturitions||Standard Error|Least Squares Mean
2777489|NCT00688688|Primary|Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.|||participants|||Number
2777490|NCT00688662|Secondary|Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.|Successful outcome was defined using the primary outcome definition of success at 12 months post randomization. Abnormal sphincter manometry was determined as a basal pressure of more than 40mm Hg in both leads.|1 year|Participants with abnormal sphincter manometry|||percentage of participants with success|||Number
2777491|NCT00688662|Primary|Percentage of Participants With Success|The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of <6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.|1 year|The primary analysis was conducted with the intention-to-treat population defined as all randomized patients.|||percentage of paricipants with success||95% Confidence Interval|Number
2777492|NCT00688636|Secondary|Mean Erythrocyte Sedimentation Rate|erythrocyte sedimentation rate value - blood test|one year||||mm/h||Full Range|Median
2777493|NCT00688636|Secondary|C-reactive Protein Concentration as a Surrogate Marker of Inflammation|The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.|one year||||mg/dL||Full Range|Median
2777494|NCT00688636|Secondary|Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis|Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.|One year|Histologic activity score|||participants|||Number
2777495|NCT00688636|Secondary|Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200|The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit [(typical-current) X 6] Normal average male = 47, female =42, body weight|One year|CDAI score > 200|||participants|||Number
2777496|NCT00688636|Primary|Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year|Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts' Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.|one year|The proportion of patients with endoscopic recurrence (> or = i2) at 1 year after surgery|||participants|||Number
2777497|NCT00688623|Secondary|Overall Survival (OS) for Per Protocol (PP) and ITT Sets|OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died at date of database closure, overall survival was censored at the date of last contact.|baseline up to approximately 15 months|subjects who met required criteria|||days||Standard Error|Mean
2777498|NCT00688623|Secondary|Duration of Progression Free Survival (PFS) for Per Protocol (PP) and ITT Sets|Duration of PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause. Observations from patients not experiencing tumor progression or death at date of database closure were censored with the date of their last adequate tumor assessment. Progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions.|baseline up to approximately 12 months|subjects who met required criteria|||days||95% Confidence Interval|Median
2777499|NCT00688623|Secondary|Percentage of Participants' Biochemical Response Rate Based on the Tumor Marker Chromogranin A (CgA)|Biochemical response was defined as level and change from baseline in CgA during the course of the trial. The resulting values showed a high variation and were not interpretable, as different methodology was used for the assessment of CgA at the individual centers.|baseline up to approximately 12 months|The resulting values showed a high variation and were not interpretable, as different methodology was used for the assessment of CgA at the individual centers.||||||
2777502|NCT00688623|Primary|Percentage of Participants With a Overall Response Rate With a Complete Response (CR) or Partial Response (PR) at 12 Months ITT Set|"The best overall response (BOR) was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed not less than 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.~CR required disappearance of all target and non-target lesions."|baseline up to approximately 12 months||||percentage of participants|||Number
2777503|NCT00688623|Primary|Percentage of Participants With Objective Response Rate at 12 Months - Per Protocol Set (PP)|Overall Response Rate (ORR) was calculated for total PP population based on central review as confirmatory, primary analysis as well as for ITT population as sensitivity analysis. It was presented with relative frequencies and the exact 2-sided 80% confidence limit (CI) computed using the Clopper-Pearson method). If the lower limit of the CI did not include p0=5%, the hypothesis that p ≤ 5% was rejected. The primary analysis was based on the PP Set|baseline up to approximately 12 months||||percentage of participants||80% Confidence Interval|Number
2777504|NCT00688623|Primary|Percentage of Participants' Best Overall Response Rate at 12 Months - Per Protocol Set (PP)|Overall response rate (ORR) was based on RECIST central assessment and defined as the percentage of patients with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR). The BOR was calculated on basis of the tumor of overall lesion response evaluated at each visit. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments obtained within 4 weeks after the criteria for response were first met. Assessments was based on RECIST criteria 1.0. Measurable disease lesions had to be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). PR required at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. CR required disappearance of all target and non-target lesions.|baseline up to approximately 12 months||||percentage of participants|||Number
2777505|NCT00688597|Secondary|Change In 6-minute Walk Test (6MWT) From Baseline To End Of Study|The 6MWT (American Thoracic Society standards) was evaluated in ambulatory participants at screening, baseline, and to the end of the study. It was a standardized test that measured the distance in meters (m) covered over a 6-minute walk. Reference equations used (for 6MWT distance in healthy adults) included: (height in centimeters [cm], weight in kilograms [kg]) 6MWT distance for men = [7.57 × height (cm)] - [5.02 × age] - [1.76 × weight (kg)] - 309 m; 6MWT distance for women = [2.11 × height (cm)] - [5.78 × age] - [2.29 × weight (kg)] + 667 m|Baseline, Week 11|Safety Population: All participants who received at least 1 dose of duvoglustat.|||m||Standard Deviation|Mean
2777506|NCT00688597|Primary|Proportion Of Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs)|The number of participants experiencing severe TEAEs is presented for participants who received duvoglustat treatment in this open-label study. The duration of duvoglustat exposure for Cohort 1 ranged from 2 to 24 days, and their exposure ranged from a total of 7,500 to 32,500 milligrams of duvoglustat. An adverse event (AE) refers to any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation in the clinical study. The following guideline was used to grade the intensity of an AE: mild, the AE is easily tolerated and does not interfere with daily activity; moderate, the AE interferes with the daily activity but the participant is still able to function; severe, the AE is incapacitating and requires medical intervention. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline, Week 11|Safety Population: All participants who received at least 1 dose of duvoglustat.|||Participants|||Count of Participants
2777507|NCT00688545|Primary|JIA Concomitant Medications|JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.|Year 2 or early termination|Safety Analysis Set subset of participants who received JIA concomitant medications|||Participants|||Number
2777508|NCT00688545|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.|Baseline up to 2 years|Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.|||Participants|||Number
2777509|NCT00688519|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|ITT|||participants|||Number
2777510|NCT00688519|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 weeks|ITT|||participants|||Number
2777511|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 weeks|ITT|||participants|||Number
2777512|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 weeks|ITT|||participants|||Number
2777513|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 weeks|ITT|||participants|||Number
2777514|NCT00688519|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population|||particpants|||Number
2777515|NCT00688467|Secondary|Number of Participants Discontinued From the Study Because of an Adverse Event|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. Discontinuations due to an AE are reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug|||Participants|||Number
2777516|NCT00688467|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. AEs were reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug|||Participants|||Number
2777517|NCT00688467|Secondary|Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. ECP level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|ECP level was not analyzed because too few evaluable samples were collected||||||
2777518|NCT00688467|Secondary|Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. MPO level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|MPO level was not analyzed because too few evaluable samples were collected||||||
2777519|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. Neutrophil elastase activity was measured in the sputum supernatant as milli units/mL (mU/mL). Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples|||mU/mL||Standard Deviation|Least Squares Mean
2777520|NCT00688467|Secondary|Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. IL-8 level was measured in the sputum supernatant. Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples|||pg/mL||Standard Deviation|Least Squares Mean
2777521|NCT00688467|Secondary|Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and had evaluable blood samples available|||Percent change from baseline||Standard Deviation|Least Squares Mean
2777522|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were collected via the nebulized method. Baseline values were determined at 24 hours before allergen challenge in each treatment period. Sputum neutrophils were measured as percent of total white blood cells. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples|||Percent change from baseline||Standard Deviation|Least Squares Mean
2778141|NCT00684047|Secondary|Prevalence of Treatment Failures|The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population|||percentage of participants|||Number
2777523|NCT00688467|Secondary|Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. The EAR was 0 to 2 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Percent change from baseline||Standard Deviation|Least Squares Mean
2777524|NCT00688467|Secondary|Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of Early Asthmatic Response (EAR) between 0 to 2 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. A percent change >0 indicates a reduction in FEV1 from before to after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Percent change from baseline||Standard Deviation|Least Squares Mean
2777525|NCT00688467|Secondary|Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge|This is a measure of allergen-induced changes in airway responsiveness to methacholine. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Log methacholine (mg/mL)||Standard Deviation|Least Squares Mean
2777526|NCT00688467|Secondary|Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. The LAR was 3 to 7 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Liters||Standard Deviation|Least Squares Mean
2777527|NCT00688467|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods|||Percent change from baseline||Standard Deviation|Least Squares Mean
2777528|NCT00688376|Secondary|Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale|Behavioral Rating Inventory of Executive Functioning test evaluates impairment of executive function(planning and organization),memory,and sustained attention in children aged 5-18 years with wide range of developmental and acquired neurological conditions.Survey assess parent/guardian's perception of their child's executive functioning in home and school environments,which relate to daily function(as judged by parent).Each survey contains 86 items scored as;1(behavior is never a problem),2(behavior is sometimes a problem),or 3(behavior is often a problem).Data was presented as t-scores(raw scale scores are used to generate t-scores)for Global Executive Composite Score(t-score range 72-216),Behavioral Regulation Index(t-score range 28-84;inhibit,shift,and emotional control),Metacognition Inde (t-score range 44-132;initiate,working memory,plan/organize,organization of materials, and monitor),and Working Memory Subscale(t-score range 35-90).Higher scores indicate decline in performance.|Baseline and Week 12|ITT population LOCF|||t-scores||Standard Deviation|Mean
2777529|NCT00688376|Secondary|Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12|The Reaction Time Variability is defined as the time measurement of how consistently the switch is pressed. The Response Time is the measurement of how fast or slow information is processed and responded to by the participant. The testing process was as described in a previous outcome measure. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.|Baseline, Weeks 6 and 12|Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT d-prime standard score was available at both Screening and at least one visit after the first dose of study drug during the Double-Blind Phase.|||milliseconds||Standard Deviation|Mean
2777540|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Creatinine|"Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777907|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||participants|||Number
2777530|NCT00688376|Secondary|"Change From Baseline in the TOVA-CPT D-prime Standard Score (SS) at Week 6"|"TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of Hits (correct responses), omission errors (failure to respond), commission errors/False Alarms (incorrect responses), response time, and sensitivity (d-prime). D-prime a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of d-prime is reached by having more Hits (correct response) and fewer False Alarms (incorrect response). Analysis was based on three factors: the d-prime standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder."|Baseline and Week 6|Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT d-prime standard score was available at both Screening and at least one visit after the first dose of study drug during the Double-Blind Phase.|||d-prime||Standard Deviation|Mean
2777531|NCT00688376|Primary|"Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) D-prime Standard Score (SS) at Week 12"|"TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of Hits (correct responses), omission errors (failure to respond), commission errors/False Alarms (incorrect responses), response time, and sensitivity (d-prime). D-prime a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of d-prime is reached by having more Hits (correct response) and fewer False Alarms (incorrect response). Analysis was based on three factors: the d-prime standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder."|Baseline and Week 12|"Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT d-prime standard score was available at both Screening and at least one d-prime score from the treatment period, in addition to having a post-Baseline safety assessment."|||d-prime||Standard Deviation|Mean
2777532|NCT00688324|Secondary|Cognitive Impairment|"Cognitive tests will include the DigitSymbol Test (evaluating processing speed), California Verbal Learning Test (CVLT; evaluating verbal learning and episodic memory), and NBack (evaluating working memory).~Digit Symbol scaled scores range from 1 to 19, with the larger numbers indicating better performance.~On the CVLT, the delayed recognition score ranges from 0 to 16, with the larger numbers indicating better performance.~On the NBack test, subjects were asked to recall items 0-back, 1-back, and 2-back in a sequence. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower."|Change from Baseline (Treatment Week 0) to End of Study (Treatment Week 2)|Subjects who completed cognitive testing at both study time points.|||units on a scale||Standard Deviation|Mean
2777533|NCT00688324|Secondary|SANS - Negative Symptoms of Schizophrenia Total Score|Negative symptoms of schizophrenia measured using the Scale for the Assessment of Negative Symptoms (SANS) Total Score. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline (Treatment Week 0) and End of Study (Treatment Week 2)|Subjects completing the SANS assessment at each time point.|||units on a scale||Standard Deviation|Mean
2777534|NCT00688324|Secondary|BPRS - Symptoms of Psychosis Total Score|"The psychosis total score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (Treatment Week 0) and End of Study (Treatment Week 2)|Subjects completing BPRS rating at each time point.|||units on a scale||Standard Deviation|Mean
2777535|NCT00688324|Secondary|BPRS - Symptoms of Psychosis Change in Scores|"Symptoms of psychosis were measured with the Brief Psychiatric Rating Scale (BPRS). The items rated for psychosis are Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content. Each item score ranges from 1=Not Present to 7=Very Severe.~Value at End of Study minus value at Baseline."|Baseline (Treatment Week 0) and End of Study (Treatment Week 2)|Subjects completing the BPRS rating at Baseline and End of Study.|||units on a scale||Standard Deviation|Mean
2777536|NCT00688324|Primary|Fractional Anisotropy Measured With Diffusion Tensor Imaging|Diffusion Tensor Imaging Frational Anisotropy (FA) Measures by Lifetime History of Alcohol Abuse/Dependence and Brain Hemisphere.|Completion of two scans|Subjects completing study (both scans).|||FA||Standard Deviation|Mean
2777537|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Myo-inositol|"Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777538|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - N-acetylaspartate|"N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777539|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Glutamate|"Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777541|NCT00688324|Primary|Left Dorsal Lateral Prefrontal Cortex - Choline|"Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777542|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Myo-inositol|"Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777543|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - N-acetylaspartate|"N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777544|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Glutamate|"Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777545|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Creatinine|"Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777546|NCT00688324|Primary|Right Dorsal Lateral Prefrontal Cortex - Choline|"Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Usable scan data.|||mM||Standard Deviation|Mean
2777547|NCT00688324|Primary|Anterior Cingulate Cortex - Myo-inositol|"Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
2777548|NCT00688324|Primary|Anterior Cingulate Cortex - N-acetylaspartate|"N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
2777549|NCT00688324|Primary|Anterior Cingulate Cortex - Glutamate|"Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
2777550|NCT00688324|Primary|Anterior Cingulate Cortex - Creatinine|"Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
2777551|NCT00688324|Primary|Anterior Cingulate Cortex - Choline|"Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in mM."|Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)|Subjects entering baseline screening minus the two subjects with missing alcohol abuse history.|||mM||Standard Deviation|Mean
2777552|NCT00688259|Secondary|Changes in Distress From Schizophrenia Symptoms|"Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress~Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889."|Pre-treatment to follow-up, approximately 6 months post end-of-treatment||||units on a scale||Standard Error|Least Squares Mean
2777553|NCT00688259|Secondary|Changes in Distress From Schizophrenia Symptoms|"Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress~Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889."|Pre-treatment to end-of-treatment, approximately 6 months post-randomization||||units on a scale||Standard Error|Least Squares Mean
2777554|NCT00688259|Primary|Changes in Global Social Functioning|"Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler N, Hogarty G, Weissman M:, 1979) with low scores indicating better functioning~Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303)"|Pre-treatment to follow-up, approximately 6 months post end-of-treatment||||units on a scale||Standard Error|Least Squares Mean
2777555|NCT00688259|Primary|Changes in Global Social Functioning|"Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler, Hogarty, Weissman:, 1979) with low scores indicating better functioning~Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303)"|Pre-treatment to end of treatment, approximately 6 months post-randomization||||units on a scale||Standard Error|Least Squares Mean
2777556|NCT00688259|Primary|Changes in Positive Schizophrenia Symptoms|"Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms~Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243"|Pre-treatment to follow-up, approximately 6 months post end-of-treatment||||units on a scale||Standard Error|Least Squares Mean
2777557|NCT00688259|Primary|Changes in Positive Schizophrenia Symptoms|"Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms~Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243"|Pre-treatment to end of treatment, approximately 6 months post-randomization||||units on a scale||Standard Error|Least Squares Mean
2777558|NCT00688155|Secondary|Composite Episodic Memory|"Composite of 4 components.~The Hopkins Verbal Learning Test (HVLT) of verbal learning. Subjects hear 12 words and repeat as many as possible. This is repeated twice for a total of 3 trials. 20 mins later the subject is asked to recall as many words as possible. Subjects also do a recognition trial with 24 words. Scores for immediate and delayed recall, and recognition are calculated.(Brandt J. Clin Neuropsych 1991;5:125-42).~The Logical Memory (LM) test The LM test has 2 parts. In Part 1, subjects hear a story and recall as many pieces as possible immediately and after a 30 minute delay. Subjects receive a story unit score for accuracy of re-telling story details and a thematic score for recalling story themes. The higher the scores the better the performance. ( Wechsler D. The Wechsler Memory Scale-3rd Edition (WHM-III). Psycholog Corp, Harcourt, Inc.)~Individual scores are converted to z-scores and averaged to form the composite."|Change a 4 months|Participants assessed at 4 months|||z-scores (e.g. SD units)||Standard Error|Mean
2777559|NCT00688155|Secondary|Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below.|"Composite of 5 tasks:~Self-Ordered Pointing Task of planning, working memory, and monitoring. Subjects view 16 abstract shapes and choose a shape so that each is selected by the 16th trial and none is chosen more than once. (Eriksen, Percept Psychophysiology 1974;16:143-49).~N-Back Test of working memory. Subjects see individual letters and indicate whether the letter is the same as the nth back letter, with n equal to 1 and 2. (Dobbs, Psychol Aging 1989;4:500-3.)~Eriksen flanker task of response incompatibility. Subjects see an arrow facing either right or left and indicate the direction.The target displays can be neutral congruent, or incongruent. (Eriksen, Percept Psychophys 1974;16:143-49.)~Trail Making Test-Part B of alternating attention. Subjects connect 25 labeled circles and are scored by completion time. The lower the scores the better the performance. See details in the primary outcome.~Raw scores for each test were converted to z-scores."|Baseline to 4 months|Participants assessed at 4 months -- note some dropouts occurred|||z-scores (e.g. SD units)||Standard Error|Mean
2777560|NCT00688155|Primary|Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests.|"6 measures of executive functioning: Self-Ordered Pointing task (24): working memory~1- and 2-Back tests (25-26): working memory Eriksen flanker (27): response inhibition Task Switching (28): attentional flexibility Trail Making (29): executive function z-score=(raw score-mean)/standard deviation 4 measures of episodic memory Hopkins Verbal Learning Test (30) Wechsler Memory Scale-III (31)~A composite of 10 scores: dividing each's difference from the baseline mean by the baseline SD, averaging the 6 executive function and 4 episodic memory z-transformed measures, and norming to have SD 1.~24. Petrides. Neuropsych 1982;20:249-62. 25. Dobbs. Psychol Aging 1989;4:500-3. 26. Jonides. J Cog Neurosci 1997;9:462-75. 27. Ericksen. Br J Sports Med 2009;43:22-4. 28. Kramer. Acta Psychologica 1999;101:339-78. 29. Reitan. Per Motor Skills 1958;8:271-6. 30. Brandt. Clin Neuropsych 1991;5:125-42. 31. Wechsler D.1997. Psychological Corporation, Harcourt, Inc: San Antonio."|Changes from baseline at 4 months in z-scores.|Participants assessed at four months post-randomization. Note that this does not include all who were randomized due to dropout.|||z-scores (e.g.Standard Deviation Units)||Standard Error|Mean
2777561|NCT00688103|Primary|Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score|"The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.~Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.~For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, <50% of the original joint space; 3=general, >50% of the original joint space or subluxation; 4=ankylosis."|at 52 weeks||||units on a scale||Standard Deviation|Mean
2777584|NCT00687908|Primary|Maintenance Success for Total Lesions at Week 24|Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.|Week 24|ITT - Worst-case (Any missing data at Week 24 is considered as a failure)|||percent of subjects|||Number
2777562|NCT00688103|Primary|ACR50 Response Rate|ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).|at 24 weeks||||percentage of responders|||Number
2777563|NCT00688103|Primary|EULAR Good Response|EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by > 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 < 3.2 is regarded as low disease activity.|at 24 weeks||||percentage of responders|||Number
2777564|NCT00688064|Secondary|Percent of Subjects With Adverse Events|Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)|Up to 12 weeks|ITT|||% of subjects|||Number
2777565|NCT00688064|Secondary|Success Rate on the Investigator's Global Assessment|"Percentage of subjects graded Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12"|Week 12|ITT, LOCF|||% of subjects|||Number
2777566|NCT00688064|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12||Week 12|ITT, LOCF|||% of change||Full Range|Median
2777567|NCT00688064|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.||Week 12|ITT, LOCF|||% of change||Full Range|Median
2777568|NCT00688064|Primary|Percent Change From Baseline in Total Lesion Counts at Week 12.||Week 12|ITT, LOCF|||% of change||Full Range|Median
2777569|NCT00687973|Secondary|Change From Baseline of Pulse Pressure at Week 24 (Office BP)||Baseline and Week 24|ITT Population|||mmHg||Standard Deviation|Least Squares Mean
2777570|NCT00687973|Secondary|Change From Baseline of SBP/DBP at Week 24 (Office BP)||Baseline and Week 24|ITT Population|||mmHg||Standard Error|Least Squares Mean
2777571|NCT00687973|Secondary|Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)||Baseline and Week 24|ITT Population|||mmHg||Standard Error|Least Squares Mean
2777572|NCT00687973|Secondary|Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)|Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.|Baseline and Week 24|ITT population|||mmHg||Standard Error|Least Squares Mean
2777573|NCT00687973|Secondary|Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||m/s||Standard Error|Least Squares Mean
2777574|NCT00687973|Secondary|Change From Baseline of Aix Corrected to Heart Rate at Week 24|The heart rate correction was computed by a multivariate model analysis|Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||Ratio||Standard Error|Least Squares Mean
2777575|NCT00687973|Secondary|Change From Baseline of Aix at Week 24||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||Ratio||Standard Error|Least Squares Mean
2777576|NCT00687973|Secondary|Change From Baseline of Augmentation Index (Aix) at Week 8|To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.|Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||Ratio||Standard Error|Least Squares Mean
2777577|NCT00687973|Secondary|Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||mmHg||Standard Error|Least Squares Mean
2777578|NCT00687973|Secondary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)||Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||mmHg||Standard Error|Least Squares Mean
2777579|NCT00687973|Primary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)|||mmHg||Standard Error|Least Squares Mean
2777580|NCT00687908|Secondary|Percent of Subjects With Adverse Events|All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent|Up to 24 weeks||||percent of subjects|||Number
2777581|NCT00687908|Secondary|Investigator Global Assessment (IGA) Maintenance Success at Week 24|"IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.~IGA grade:~0 Clear:Residual hyperpigmentation & erythema may be present~Almost Clear:A few scattered comedones & a few small papules.~Mild:Some comedones & some papules and pustules. No nodules present~Moderate:Many comedones, papules & pustules. One nodule may be present~Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present~Very severe:Highly inflammatory acne covering the face; with nodules & cysts present"|Baseline, Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)|||percent of subjects|||Number
2777582|NCT00687908|Secondary|Maintenance Success for Non-inflammatory Lesions at Week 24|Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)|||percent of subjects|||Number
2777583|NCT00687908|Secondary|Maintenance Success for Inflamatory Lesions at Week 24|Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)|||percent of subjects|||Number
2777585|NCT00687856|Secondary|Refine and Test Feedback Control Algorithm That Allows Precise Prescription of Cardiac Loading Through Synchronized and Asynchronized LVAD Operation With Native Left Ventricular Contraction||Measured at Year 3|||||||
2777586|NCT00687856|Primary|Number of Subjects With Left Ventricular Recovery and LVAD Explant|Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery. These markers would determine LVAD patients with cardiac recovery who no longer needed LVAD support.|Number of participants who had LV recovery and LVAD explant over 3 years.|The outcome measured were the number of patients who had cardiac recovery and who no longer required LVAD support and had successful LVAD explant. Of 211 LVAD recipients, there were 8 who had successful LVAD explant|||Participants|||Count of Participants
2777587|NCT00687830|Secondary|Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.|Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.|An hour before the colonoscopy procedure||||participants|||Number
2777588|NCT00687830|Primary|Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.||Within 1 hr after the colonoscopy procedure||||units on a scale||Standard Deviation|Mean
2777589|NCT00687804|Secondary|Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Core baseline (Day 1 of the core study), Month 36 (end of extension study)|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Letters||Standard Deviation|Mean
2777590|NCT00687804|Secondary|Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Extension baseline (Month12 -end of core study), Month 36 (end of extension study)|Participants from the Safety Population that included all participants who entered the extension and who had at least one safety assessment in the extension study with data available for analyses. Participants were grouped according to the treatment assigned in the Core study.|||Letters||Standard Deviation|Mean
2777591|NCT00687804|Primary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
2777592|NCT00687804|Secondary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
2777593|NCT00687804|Secondary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
2777606|NCT00687713|Primary|Number of Subjects Showing Abstinence|The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.|Weeks 11 and 12||||Participants|||Count of Participants
2777607|NCT00687674|Secondary|Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)||Post treatment|||||||
2777608|NCT00687674|Secondary|Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II||Post treatment|||||||
2777594|NCT00687804|Primary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.|||Percentage of participants|||Number
2777595|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Patient-reported Visual Functioning|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including the number of patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.|||Units on a scale||Standard Deviation|Mean
2777596|NCT00687804|Secondary|Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.|||Micrometers||Standard Deviation|Mean
2777597|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set, utilizing last observation carried forward.|||Letters||Standard Error|Mean
2777598|NCT00687804|Secondary|Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.|||Participants|||Number
2777599|NCT00687804|Primary|Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline through the end of study (Month 12)|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.|||Letters||Standard Deviation|Mean
2777600|NCT00687739|Secondary|Fat-free Mass|Total body fat-free mass measured by DXA|Before and after 5 months of treatment|Participants who completed outcome measurements before and after the interention|||kg||95% Confidence Interval|Mean
2777601|NCT00687739|Secondary|Fat Mass|Total body fat mass measured by DXA|Before and after 5 months of treatment||||kg||95% Confidence Interval|Mean
2777602|NCT00687739|Secondary|Total Energy Expenditure (TEE)|24-hour energy expenditure measured by indirect calorimetry in a room calorimeter|Before and after 5 months of treatment|Participants who completed 24-h visits in the room calorimeter before and after the intervention|||kcal/d||95% Confidence Interval|Mean
2777603|NCT00687739|Primary|Cortisol Response (Area Under the Curve) to CRH Under DEX Suppression|Cortisol response to corticotropin releasing hormone (CRH) during dexamethasone (DEX) suppression; DEX/CRH stimulation test|Before and after 5 months of treatment|Women who completed the DEX/CRH stimulation test before and after the intervention. The Outcome Measure evaluation was only conducted in a subgroup of women – those in the Drug intervention arms. This evaluation was not done in the exercise arms.|||ng/mL x min||95% Confidence Interval|Mean
2777604|NCT00687739|Primary|Resting Energy Expenditure (REE)|Resting energy expenditure measured by indirect calorimeter at baseline and after 5 months of treatment.|Before and after 5 months of treatment|Participants who completed 24-h visits in the room calorimeter before and after the intervention. This could not be accomplished in all participants in the trial because of scheduling difficulties and/or lack of availability of the calorimeter. The primary analysis was by drug group only (placebo vs estradiol), collapsed across exercise grouping.|||kcal/d||95% Confidence Interval|Mean
2777605|NCT00687713|Secondary|Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use|The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.|30 days||||Participants|||Count of Participants
2777609|NCT00687674|Secondary|Plasma Cell Gene Expression Profiles and Correlation With > Clinical Outcomes||Post treatment|||||||
2777612|NCT00687674|Secondary|Time to Disease Progression (Phase II)|"Time to disease progression (TTP) was defined as the time from registration to progression. The median TTP with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|From registration to progression (up to 3 years)|No participants proceeded to Phase II for evaluation.||||||
2777613|NCT00687674|Secondary|Overall Survival (Phase II)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 2 years from registration. The median OS with 95%CI was estimated using the Kaplan Meier method|From registration to death (up to 3 years)|No participants proceeded to Phase II for evaluation.||||||
2777614|NCT00687674|Primary|Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)|"Response that was confirmed on 2 consecutive evaluations during treatment~CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)~sCR: CR plus normal FLC ratio & absence of clonal cells in BM~VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration on Treatment (up to 3 years)|No participants proceeded to Phase II for evaluation.||||||
2777615|NCT00687674|Primary|Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|up to 3 years|One participant refused further treatment prior to being assessed for adverse events.|||participants|||Number
2777616|NCT00687609|Secondary|C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4|Participants rate most common and most severe ideation type by frequency (1=<once per week/5=many times/day), duration (1=fleeting/5=>8 times per hour persistent, continuous), controllability (1=easily able to control thoughts/8=no attempt), deterrents to active attempts (1=deterrent definitely stopped you/8=N/A, wish to die only), and reason for ideation (1=completely for attention/revenge/reaction/5=completely to stop the pain). Only items with yes responses at a given week are listed. A participant could have a yes response in more than one item.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Participants|||Number
2777617|NCT00687609|Secondary|C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts|Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses at a given week are listed.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Participants|||Number
2777618|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task|For the Time Reproduction Task participants need to reproduce the duration of a visual stimulus (lightbulb) by pressing a button. The intervals vary between 2 - 20 seconds. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Milliseconds||Standard Deviation|Mean
2777619|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task|For the Contingency Task participants estimate the duration of a time interval of 1 second by pushing a button. Responses that are within a dynamic time interval are being classified as correct. This way, 50 % of the responses are correct, 50% incorrect. Three contingency conditions: neutral, reward and response cost. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Milliseconds||Standard Deviation|Mean
2777620|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task|Consists of 2 types of trials: go trials and stop trials. Go trials require participants to locate the position of an aircraft displayed to the left or right of a fixation point on a computer screen by pressing a left or right button. In 25% of the go stimili an additional stop stimulus (auditory signal) is presented shortly after the go stimulus. Participant then needs to inhibit their response. By varying the time period between go and stop stimulus, 50% of the trials are inhibited successfully, 50% not. The latency of inhibition is estimated. This task takes about 25 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Milliseconds||Standard Deviation|Mean
2777621|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)|The MCQ is a 12-item self-rated questionnaire to assess cannabis craving with 4 factors: compulsivity (an inability to control marijuana use), emotionality (use of marijuana in anticipation of relief from withdrawal/negative mood), expectancy (anticipation of positive outcomes from smoking marijuana) and purposefulness (intention and planning to use marijuana for positive outcomes). Scores are calculated on a 7-point scale (1=strongly disagree; 7=strongly agree). A separate score is calculated for each factor; scores range from 3-21 each with higher scores indicating greater craving.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2777622|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2777623|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2777624|NCT00687609|Secondary|Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version|The Global Impression of Perceived Difficulties (GIPD) scale is a five-item rating of ADHD-related difficulties. For each item, difficulties during the past week are rated on a 7 point scale (1=normal, not difficult at all; 7= extremely difficult). The GIPD total score is the sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. The scale is completed by the participant.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2777625|NCT00687609|Secondary|Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2777626|NCT00687609|Primary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2777627|NCT00687544|Secondary|Number of Participants Experiencing Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.|Throughout the study (up to 72 weeks)||||participants|||Number
2777628|NCT00687544|Secondary|Number of Participants Who Died||Throughout the study (up to 72 weeks)||||participants|||Number
2777629|NCT00687544|Primary|Number of Participants Who Achieved Sustained Biochemical Response (SBR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).~The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)|||||||
2777630|NCT00687544|Secondary|Number of Participants Experiencing Opportunistic Infection|The study was terminated due to low enrollment. This analysis was not performed.|Throughout the study (up to 72 weeks)|||||||
2777631|NCT00687544|Primary|Number of Participants Who Achieved Virologic Response (VR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~The study was terminated due to low enrollment. This analysis was not performed."|24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)|||||||
2777632|NCT00687544|Primary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).~The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment)|||||||
2777633|NCT00687531|Secondary|Number of Participants With Use of Rescue Medication in Each Episode||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||episodes||
2777634|NCT00687531|Secondary|Number of Participants Who Adhered to Treatment|The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance.|Day 1 to Week 12|study completers (per protocol population)|||participants|||Number
2777635|NCT00687531|Secondary|Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations|Exacerbation severity will be characterized based on exacerbation classification from the Global Initiative for Asthma (GINA) workshop 2005 and the National Heart Lung and Blood Institute (NHLBI) asthma guidelines.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
2777637|NCT00687531|Secondary|Investigator's Assessment of Response to Therapy Based on a 5-point Scale|The investigator will assess the subject's response to therapy by interviewing the subject and comparing the current level of symptoms from baseline. A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.||||||
2777638|NCT00687531|Secondary|Number of Puffs of Salbutamol Used Daily||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
2777639|NCT00687531|Secondary|Number of Nocturnal Awakenings||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
2777640|NCT00687531|Secondary|Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).|The symptoms of cough, chest tightness, wheezing, and shortness of breath were each to be graded on a scale of 0 to 3 with 0 being no symptoms present and 3 being very marked symptoms which was disturbing most of the time. Scores were to have been recorded at 12AM and 12PM for a total of 24 points summed.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.||||||
2777641|NCT00687531|Secondary|Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint|"Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...~The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question."|Day 1 and Week 12|study completers (per protocol population)|||questions|questions||Number
2777642|NCT00687531|Secondary|Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)|Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)|||Liters/minute||Standard Deviation|Mean
2777643|NCT00687531|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)|||Liters||Standard Deviation|Mean
2777644|NCT00687453|Secondary|Any Adverse Event Other Than Hypoglycemia||6 months|||||||
2777645|NCT00687453|Secondary|Total Daily Insulin Dose||6 months|||||||
2777646|NCT00687453|Secondary|Body Mass Index Change From Baseline||6 months|||||||
2777647|NCT00687453|Secondary|Frequency of Severe Hypoglycemic Reactions||6 months|||||||
2777648|NCT00687453|Secondary|Frequency of Total Hypoglycemic Reactions||6 months|||||||
2777649|NCT00687453|Secondary|Frequency of Pre-supper Glucose Readings 120 mg/dL or Less||6 months|||||||
2777650|NCT00687453|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)|||Percent||Standard Deviation|Mean
2777651|NCT00687440|Primary|Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.|Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.|Intent-to-treat population|||Participants|||Number
2777652|NCT00687401|Primary|Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score|"PASI 75 response is defined as participants who achieved at least a~75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks|"Intent to Treat Population (ITT): 159 participants out of the 215 enrolled patients who received at least one dose of the study drug.~Per Protocol Population (PP): 138 participants not withdrawn from the study due to major protocol violation and who have received the three infusions of the study drug planned by the protocol."|||Participants|||Number
2777653|NCT00687362|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10|"PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10.~The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks||||participants|||Number
2777654|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G|The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social & emotional well being, whether a high score or a lower one indicated a better outcome depended on the question.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.||||||
2777655|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13|The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.||||||
2777908|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||participants|||Number
2777656|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30|The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.||||||
2777657|NCT00687323|Secondary|Progression-free Survival for Participants Achieving PR, MLSF, or MR|Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) who achieved PR, MLSF, or MR|||months||95% Confidence Interval|Median
2777658|NCT00687323|Secondary|Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity|Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions.|From first dose to 30 days after last dose of study drug (up to 67 weeks)|Number of participants who achieved CR, PR, or MLFS and received modified low dose maintenance therapy|||participants|||Number
2777659|NCT00687323|Secondary|MGMT Expression in Leukemic Blasts at the Time of Relapse|"Low MGMT expression was defined as MGMT/β-actin ratio of <0.2.~MGMT & β-actin are cancer biomarkers."|Up to 1 year after treatment ends (up to 115 weeks)|Analysis could not be performed due to lack of specimens.||||||
2777660|NCT00687323|Secondary|Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression|Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers.|Baseline|All screened participants|||participants|||Number
2777661|NCT00687323|Secondary|Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|"OS was defined as the time from start of treatment until death or end of study.~Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent."|Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||months||95% Confidence Interval|Median
2777662|NCT00687323|Secondary|Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||months||95% Confidence Interval|Median
2777663|NCT00687323|Secondary|Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.|Up to 1 year after treatment ends (up to 115 weeks)|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||Days||Full Range|Median
2777664|NCT00687323|Primary|Clinical Response at the End of Temozolomide Induction|"Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.~CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.~Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met.~Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts."|at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)|||participants|||Number
2777665|NCT00687297|Secondary|Progression-free Survival|Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation.|every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance)|All randomized patients were included.|||months||95% Confidence Interval|Median
2777666|NCT00687297|Secondary|Objective Response Rate|Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0)|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.|||percentage of participants||95% Confidence Interval|Number
2777667|NCT00687297|Primary|Progression-free Survival|Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.|||Months||95% Confidence Interval|Median
2777668|NCT00687271|Secondary|Percentage Change From Baseline in TG|Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage of Participants||95% Confidence Interval|Median
2777669|NCT00687271|Secondary|Percentage Change From Baseline in HDL-C|Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2777670|NCT00687271|Secondary|Percentage Change From Baseline in Total Cholesterol (TC)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2777671|NCT00687271|Secondary|Percentage Change From Baseline in Apolipoprotein B (ApoB)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2777672|NCT00687271|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2777673|NCT00687271|Secondary|Percentage of Participants That Had Study Drug Discontinued Due to an AE|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.|up to 4 weeks|All participants that received at least 1 dose for study drug.|||Percentage of Participants|||Number
2777674|NCT00687271|Secondary|Percentage of Participants Who Experience at Least 1 Adverse Event (AE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized|Up to 14 days post last dose of study drug (up to 6 weeks)|All participants that received at least 1 dose for study drug.|||Percentage of Participants|||Number
2777675|NCT00687271|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.|Baseline (predose) and Week 4|All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2777676|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at End of Treatment|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Up to 48 weeks||||Participants|||Number
2777677|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at Week 24|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Week 24|Peginterferon alfa-2b administered at 1.0 μg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks|||Participants|||Number
2777678|NCT00687219|Primary|Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Measured at 24 weeks after 48 weeks treatment (72 weeks)||||Participants|||Number
2777679|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777680|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777681|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2778142|NCT00684047|Secondary|Proportions of Subjects Achieving Hemostasis|The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population|||percentage of participants|||Number
2777682|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777683|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777684|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change =score at Week 12 minus score at baseline"|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777685|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777686|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777687|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777688|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777689|NCT00687193|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777690|NCT00687193|Secondary|Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)|ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2777909|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||participants|||Number
2777691|NCT00687193|Secondary|Change From Baseline in C- Reactive Protein (CRP) (mg/L)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||mg/L||Standard Error|Least Squares Mean
2777692|NCT00687193|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777693|NCT00687193|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777694|NCT00687193|Secondary|Change From Baseline in Patient's Assessment of Pain|"Change from Baseline in Patient's Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.~Change = value at observation minus value at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777695|NCT00687193|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||units on a scale||Standard Error|Least Squares Mean
2777696|NCT00687193|Secondary|Change From Baseline in Painful and Tender Joint Counts|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Weeks 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||units on a scale||Standard Error|Least Squares Mean
2777697|NCT00687193|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|"HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.~Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777698|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]|"The DAS28-4 (ESR) score is a measure of the participant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.~Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777699|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]|"The DAS28-3 (CRP) score is a measure of the perticipant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.~Change = value at observation minus value at baseline"|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.|||Units on a scale||Standard Error|Least Squares Mean
2777700|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
2777972|NCT00685334|Secondary|Medication Side Effects|Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.|Measured at Week 12|||||||
2777701|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
2777702|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
2777703|NCT00687193|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP)at each visit.|Week 2, 4, and 8|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
2777704|NCT00687193|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.|||participants|||Number
2777705|NCT00687167|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
2777706|NCT00687167|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.||||ng/mL||Standard Deviation|Mean
2777707|NCT00687102|Secondary|Mean Change From Baseline on the Geriatric Depression Scale Scores by Treatment Group|"Mean Change From Baseline on the Geriatric Depression Scale. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures depression in older adults. Mood is also assessed with the 15-item short form of the GDS which measures non-somatic features of depressed mood. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is 0-15, with 0-4 denoting better outcomes and a score of 5 and above denoting worse outcomes (depression)."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||units on a scale||Standard Error|Mean
2777708|NCT00687102|Secondary|Mean Change From Baseline on the Positive and Negative Affect Schedule Scores by Treatment Group|"Mean Change From Baseline on the Positive and Negative Affect Schedule (PANAS). Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures positive and negative affect. Mood is assessed with the PANAS, a list of ten pleasant mood states (e.g., interested, proud, inspired) and ten unpleasant mood states (e.g., irritable, guilty, jittery). Respondents are asked to rate on a 5-point scale (1 being very slightly or not at all and 5 being extremely) the extent to which they have experienced each mood during a specific time frame. Ratings for each item can range from 0 to 4 with total scores for positive affect and negative affect subscales ranging from 0 to 40. For positive affect, higher scores denote higher levels of positive affect and for negative affect, lower scores denote lower levels of negative affect."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||units on a scale||Standard Error|Mean
2777709|NCT00687102|Secondary|Mean Change From Baseline on the Finger Tapping Test Scores by Treatment Group|"Mean Change From Baseline on the the Finger Tapping Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures motor speed, coordination, attention, alertness, slowing of responses, and motor control. In this test of motor speed and dexterity participants are asked to depress a lever as many times as possible in each of 7, 10-second trials, first with the right hand and next with the left hand. The highest and lowest scores are dropped; the score is the average of the remaining five trials for each hand.Higher scores represent better outcomes."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||finger taps||Standard Error|Mean
2777710|NCT00687102|Secondary|Mean Change From Baseline on Card Rotations Test Scores by Treatment Group|"Mean Change From Baseline on the Card Rotations Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures the ability to mentally manipulate figures in two and three-dimensions. On each of 28 trials, participants view sample line drawings of a geometric figure and 8 alterations representing 2 or 3-dimensional rotations of the drawing. Participants are asked to identify alternatives that show the sample in 2-D but not in 3-D. Total range 0 - 160 and the number of incorrect/correct responses is measure. Higher number of correct answers is a better outcome."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||correct responses||Standard Error|Mean
2777711|NCT00687102|Secondary|Mean Change From Baseline on Digit Span Test Scores by Treatment Group|"Mean Change From Baseline on the Digit Span Test - Digits Forward and Digits backward Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures reasoning, verbal ability, and memory. The participant is asked to provide immediate recall of a series of digits in forward and backward sequences. The individual's score is the total number of items correctly repeated forwards or backwards. Total range 0 - 14, higher results denotes a better outcome."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||units on a scale||Standard Error|Mean
2777712|NCT00687102|Secondary|Mean Change From Baseline on the Letter Fluency and Semantic Fluency Scores by Treatment Group|"Mean Change From Baseline on the Letter Fluency Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~Measures cognitive function. In this test, the participant names as many words as possible in 1 minute, beginning with each letter for letter fluency (F, A, and S) and category for semantic fluency (fruits and vegetables). To score the administrator, counts up the total number letters or words that the individual is able to produce. The score minimum would be 0 and the maximum would be the total of correct items named within 1 minute. Higher scores represent better outcomes."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||change in number of words||Standard Error|Mean
2777713|NCT00687102|Primary|Mean Change From Baseline on the the California Verbal Learning Test Scores by Treatment Group|"Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~The experimenter reads a list of 16 nouns aloud, at one-second intervals, in fixed order, over 3 learning trials (list A) . After each trial, the subject is asked to recall as many words as they can in any order (i.e., free recall) given a score 0-16 each. Total range as the sum of the 3 learning trials: 0 - 48. Participants were asked to recall a second interference list (List B) with a score range of 0-16. Free recall of list A are tested immediately after list B (short-delay) Total range 0- 16 , and again after 20 minutes (long-delay) 0-16. Each part of the scale is reported separately as Total List A trials, Total List B trials, Short-delay free recall, and Long-delay free recall."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||correct responses||Standard Error|Mean
2777714|NCT00687102|Primary|Mean Change From Baseline on the the Benton Visual Retention Test Scores by Treatment Group|"Mean Change From Baseline on the Benton Visual Retention (BVRT) Test scores. Adjusted for age, ethnicity, education, and baseline measure, for participants with true baseline measures.~The BVRT measures short term visual memory and visuo-constructional abilities. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score on the BVRT is the total number of errors, 0-26 represents the total number of theoretically possible errors. Lower score denotes better outcomes."|Baseline and 3 Years|Women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial.|||Number of errors||Standard Error|Mean
2777715|NCT00687076|Secondary|Change in Total Cholesterol (mg/dl) From Baseline to Month 12|Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl].|Measured at baseline and 12 months|All values are medians and interquartile range (IQR). P-values were calculated with the KruskaleWallis rank test.|||mg/dl||Inter-Quartile Range|Median
2777716|NCT00687076|Primary|Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis|"The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed.~Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4)."|Measured at baseline and 24 Months|Multilevel models were used to describe changes over time in the MRI outcome variables and to compare the drug therapy groups. The advantage of multilevel models is the capability to use data with missing or irregularly timed observations, due to death or loss to follow-up, on the outcome variable.|||mm^3, at 24-months||Standard Error|Mean
2777717|NCT00686998|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline|PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.|Baseline, Day 28||||Points on a scale||Standard Error|Mean
2777718|NCT00686972|Primary|Insulin Secretion||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.||||||
2777719|NCT00686959|Secondary|Percentage of Participants With a Post Baseline Swallowing Diary Score >=4|Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.|Baseline through 30 Days Post Study|All randomized participants with at least one post baseline swallowing diary score.|||percentage of participants||95% Confidence Interval|Number
2777720|NCT00686959|Secondary|First Site of Disease Failure in Terms of Relapse|The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.|Baseline to Relapse (Up to 66.6 Months)|All randomized participants with objective PD.|||percentage of participants||95% Confidence Interval|Number
2777721|NCT00686959|Secondary|Survival Rates at 1, 2, and 3 Years|The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.|||probability of survival||95% Confidence Interval|Number
2777722|NCT00686959|Other Pre-specified|Adverse Events: The Number of Deaths Per Treatment Group|The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 30 Days Post Study|All randomized participants who received at least one dose of study drug.|||participants|||Number
2777723|NCT00686959|Secondary|Objective Response Rate (Complete Response [CR] + Partial Response [PR])|Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline to Measured Progressive Disease (Up to 7 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2777724|NCT00686959|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)|All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.|||months||95% Confidence Interval|Median
2777725|NCT00686959|Primary|Overall Survival|Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.|||months||95% Confidence Interval|Median
2777726|NCT00686920|Secondary|Change From Baseline In Conn Score At Last Assessment|The assessment for change in mental status during the study was measured by the Conn score (also known as the West Haven score). The following scale was used in the Conn scoring system: Grade 0=No personality or behavioral abnormality detected. Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span; or impairment of addition or subtraction. Grade 2=Lethargy; disorientation for time; obvious personality change; and inappropriate behavior. Grade 3=Somnolence to semi-stupor, responsive to stimuli; confused; gross disorientation; and bizarre behavior. Grade 4=Coma, unable to test mental state. Participants entered the study with a Conn score of 0 to 2. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug.|Baseline up to Month 36|All participants who received at least 1 dose of study drug.|||score on a scale||Standard Deviation|Mean
2777727|NCT00686920|Secondary|Number Of Participants With A Significant Mean Change From Baseline In Vital Signs|Vital signs were measured and included sitting blood pressure, heart rate, oral temperature, and weight. These were collected at each scheduled study visit. Participants were placed supine for 5 minutes prior to each assessment of vital signs. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Month 36|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2777729|NCT00686920|Secondary|Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants|Hematology and blood chemistry with potentially significant values included: Hemoglobin <9, >18, or ≥3 (grams/deciliter [g/dL]) decrease from previous visit or ≥4 g/dL decrease from baseline; Hematocrit <0.27%, >0.54%, or ≥0.10% decrease from previous visit or ≥0.15% decrease from baseline; Platelets <50 or >400*10^9/(liter [L]); Prothrombin time 9 seconds above baseline or upper limit of normal range; International normalized ratio >1.7; White blood cells <2.0 or >12.0*10^9/L; Lymphocytes <13.5% or >70%; Glucose, random, serum <2.2 or >16.5 millimole (mmol)/L; Potassium ≤3.0 or ≥5.5 mmol/L; Direct bilirubin increases 3-fold from baseline or >85.5 micromole (umol)/L. Baseline value was defined as the last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Month 36|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2777730|NCT00686894|Primary|The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.|Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.|8 weeks||||Number of Enthesitis|||Number
2777731|NCT00686881|Secondary|Number of Participants With Change in Metavir Inflammation Score|Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).|Baseline and Week 48|All treated participants excluding 3 participants on the PegIFN-2b arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.|||Participants|||Number
2777732|NCT00686881|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration|The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.|Week 24|All treated participants except 1 SNMC participant who had no available data after initial treatment.|||Participants|||Number
2777733|NCT00686881|Primary|Number of Participants With Change in Metavir Fibrosis Score|Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).|Baseline and discontinuation of treatment (up to 156 weeks)|All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.|||Participants|||Number
2777734|NCT00686855|Primary|The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.|Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.|Participants were assessed at Baseline and 4 weeks after start of therapy|Of the 46 participants enrolled on the trial, 36 were deemed evaluable for response.|||participants|||Number
2777735|NCT00686842|Secondary|Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples||Screening and day 28|||||||
2777736|NCT00686842|Secondary|Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples||Screening and day 28|||||||
2777737|NCT00686842|Secondary|Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8)||Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation|||||||
2777738|NCT00686842|Secondary|Effects of Study Drug on HIV and KSHV Viral Loads||Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation|||||||
2777739|NCT00686842|Secondary|Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles||On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation|||||||
2777740|NCT00686842|Secondary|Pharmacokinetics||Days 1, 15, 28, 57|||||||
2777741|NCT00686842|Primary|Response to Treatment||After each 28-day cycle of treatment and at discontinuation of therapy|||||||
2777742|NCT00686842|Primary|Maximum Tolerated Dose||After each group of 3 subjects completes cycle 1 of treatment|||||||
2777743|NCT00686842|Primary|Safety and Toxicity of Anti-VEGF Small Molecule PTC299|Patients who experienced an adverse event of grade 3 or greater|All study visits||||participants|||Number
2777744|NCT00686803|Primary|Pharmacodynamics as Measured by cGMP Levels.|"Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax~The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible."|24 hours||||ng/mL||Full Range|Median
2777745|NCT00686803|Primary|Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.|"The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.~•Maximum concentration (Cmax)~The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible."|24 hours||||ng/mL||Standard Deviation|Mean
2777759|NCT00686725|Secondary|Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group|"MGMT was measured by immunohistochemistry (IHC).~OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 5."|||months||Standard Deviation|Median
2777746|NCT00686790|Secondary|Number of Participants With a Liver Histology Response|"The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.~The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT."|Baseline and 52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.|||Participants|||Number
2777747|NCT00686790|Primary|Number of Participants With a Combined Response|"The combined response was defined as an ALT level below the upper~reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L."|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis."|||Participants|||Number
2777748|NCT00686790|Primary|Number of Participants With a Biochemical Response|A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis."|||Participants|||Number
2777749|NCT00686790|Secondary|Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)|Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.|52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.|||Participants|||Number
2777750|NCT00686790|Primary|Number of Participants With a Virological Response|For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).|52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.|||Participants|||Number
2777751|NCT00686777|Primary|Number of Participants Discontinuing Treatment|Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.|From time of first treatment to Week 48||||participants|||Number
2777752|NCT00686777|Secondary|Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT|HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.|Measured at 24 weeks of treatment and at EOT (Treatment week 48)|All treated Participants|||percentage of participants|||Number
2777753|NCT00686777|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation|"SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.~HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result."|Measured at 24 weeks after the end of treatment (at the end of follow-up)|All treated Participants|||percentage of participants|||Number
2777754|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group|"MGMT was measured by IHC.~PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 8."|||months||Standard Deviation|Median
2777755|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group|"MGMT was measured by IHC.~PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 9."|||months||Standard Deviation|Median
2777756|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group|"MGMT was measured by IHC.~OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.~OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 6."|||percentage of participants||95% Confidence Interval|Number
2777757|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group|"MGMT was measured by IHC.~OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.~OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 7."|||percentage of participants||95% Confidence Interval|Number
2777758|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group|"MGMT was measured by IHC.~OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 4."|||months||Standard Deviation|Median
2777760|NCT00686725|Secondary|Objective Tumor Assessment After Surgery: Overall Response|"Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration.~It was assessed as follows:~Complete Response (CR): Disappearance of all enhancing tumor (measurable~or non-measurable), no corticosteroid use, and neurologically stable or~improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor~(measurable or non-measurable) for any measurable lesions or definite~improvement for any non-measurable lesions, corticosteroid dosage stable or~reduced, and neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in contrast enhancement for any~measurable lesions or definite worsening for any non-measurable lesions, or~any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded.~Stable Disease (SD): All other situations."|Up to 2 years||||participants|||Number
2777761|NCT00686725|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years||||months||95% Confidence Interval|Median
2777762|NCT00686725|Primary|Overall Survival (OS)|"OS was defined as the time from randomization to death.~OS was calculated by the Kaplan-Meier method."|Up to 2 years||||months||95% Confidence Interval|Median
2777763|NCT00686712|Secondary|Any Adverse Event Other Than Hypoglycemia|Any reported adverse event that is not hypoglycemia|6 months|Enrolled subjects|||Events|||Number
2777764|NCT00686712|Secondary|Total Daily Insulin Dose|Total daily number of units of insulin used|6 months|Enrolled subjects|||Units of insulin per day||Standard Deviation|Mean
2777765|NCT00686712|Secondary|Body Mass Index Change From Baseline|Change in body mass index from baseline BMI measurement|6 months|Enrolled subjects|||kg per square meter||Standard Deviation|Mean
2777766|NCT00686712|Secondary|Frequency of Severe Hypoglycemic Reactions|Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person|6 months|Enrolled subjects|||Severe hypoglycemic events|||Number
2777767|NCT00686712|Secondary|Frequency of Total Hypoglycemic Reactions|Frequency of hypoglycemic reactions without regard to time of occurrence|6 months|Enrolled subjects|||Hypoglycemic events per patient||Standard Deviation|Mean
2777768|NCT00686712|Secondary|Frequency of Glucose Readings < 130 mg/dL|Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL|6 months|Enrolled subjects|||percentage of readings||Standard Deviation|Mean
2777769|NCT00686712|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)|||Percent||Standard Deviation|Mean
2777770|NCT00686699|Secondary|Mean ESRS Part IV Subscores: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
2777771|NCT00686699|Secondary|Lowest ESRS Part IV Subscore: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
2777772|NCT00686699|Secondary|Mean ESRS Part III Subscores: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
2777773|NCT00686699|Secondary|Lowest ESRS Part III Subscore: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
2777820|NCT00686582|Secondary|PRNT GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Individual peak is defined as the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.|within 26 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.|||Titer||95% Confidence Interval|Geometric Mean
2777774|NCT00686699|Secondary|Mean ESRS Part II Subscores: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
2777775|NCT00686699|Secondary|Lowest ESRS Part II Subscore: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
2777776|NCT00686699|Secondary|Mean ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
2777777|NCT00686699|Secondary|Lowest ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
2777778|NCT00686699|Secondary|Mean ESRS Total Scores Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The mean ESRS total scores at Hours 1, 2, 3, 4, 5, and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.|||Score on a scale||Standard Deviation|Mean
2777779|NCT00686699|Primary|Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of extrapyramidal symptoms (EPS) and drug-induced movement disorders (DIMD) over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The lowest ESRS total score for each participant within the 6-hour range on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.|||Score on a scale||Standard Deviation|Mean
2777780|NCT00686686|Secondary|Dermatology Life Quality Index (DLQI)|"The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a subject's QOL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI was completed by the subject prior to the PPPASI and PGA evaluations.~The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired."|Baseline and Week 12|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16.|||scores on a scale||Standard Deviation|Mean
2777781|NCT00686686|Secondary|Number of Participants Who Respond to the Fourth Infusion.|>=25% reduction in PPPASI score would be considered a response.|Week 12 and Week 18|Only three participants received a fourth infusion but according to the protocol they were not suppose to receive it at that time because their improvement in PPPASI score on Week 8 was less than 75%. Therefore, because no participants qualified to be analyzed for this endpoint, no data are given.||||||
2778160|NCT00683904|Secondary|Time of Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||Hours||Standard Deviation|Mean
2777782|NCT00686686|Secondary|Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.|"The Physician Static Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis status according to the following categories: induration, scaling, and erythema. Each category is rated from 0 to 5, where 0 represents no evidence of induration/scaling/erythema (clear), 1 represents minimal induration/scaling/erythema, and 5 represents the most severe induration/scaling/erythema."|Weeks 12 and 18|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16 for the Week 12 observations (but n=17 for the Week 18 observations).|||participants|||Number
2777783|NCT00686686|Secondary|Number of Participants Who Achieve a Moderate Response.|Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.|Baseline and Week 8|It was decided that this analysis will not be done.||||||
2777784|NCT00686686|Primary|Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.|"The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. Extent is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement."|Baseline and Week 8|Per Protocol population included the 17 subjects who completed the trial.|||participants|||Number
2777785|NCT00686647|Secondary|Major Adverse Cardiac Events|cardiac death, myocardial infarction, or target lesion revascularization|9 months||||percentage of participants|||Number
2777786|NCT00686647|Secondary|Major Adverse Cardiovascular Events|cardiac death, myocardial infarction, or target lesion revascularization|30 days|intention to treat|||percentage of particpants|||Number
2777787|NCT00686647|Primary|Procedural Success|Defined as less than or equal to 30% diameter stenosis in the main branch and less than or equal to 70% diameter stenosis in the side branch at the conclusion of the procedure (including adjunctive stenting) in the absence of in-hospital major adverse cardiac events (MACE) [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR]|1 day|intention to treat|||percentage of participants|||Number
2777788|NCT00686634|Secondary|Number of Adverse Events||1 year||||Adverse event|||Number
2777789|NCT00686634|Secondary|Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year||1 year||||participants|||Number
2777790|NCT00686634|Secondary|Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months||4 months||||participants|||Number
2777791|NCT00686634|Primary|Hemoglobin A1c (HbA1c) Change From Baseline||Baseline, 4 months|Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)|||percentage||Standard Deviation|Mean
2777792|NCT00686595|Secondary|Percent Reduction in SKINDEX-29 Scores at Week 24|"The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from never (=0) to all the time (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported."|Baseline and Week 24|Participants from the ITT population for whom the SKINDEX-29 assessments were available.|||Percent reduction||Standard Deviation|Mean
2777793|NCT00686595|Secondary|Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18|"The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from never (=0) to all the time (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported."|Baseline and Week 18|Participants from the ITT population for whom the SKINDEX-29 assessments were available.|||Percent reduction||Standard Deviation|Mean
2777794|NCT00686595|Secondary|Percent Reduction in DLQI Total Score at Week 24|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the DLQI assessment was available.|||Percent reduction||Standard Deviation|Mean
2777795|NCT00686595|Secondary|Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the DLQI assessment was available.|||Percent reduction||Standard Deviation|Mean
2777796|NCT00686595|Secondary|Percent Reduction in VAS Referred Itch at Week 24|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the VAS assessment was available.|||Percent reduction||Standard Deviation|Mean
2777797|NCT00686595|Secondary|Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the VAS assessment was available.|||Percent reduction||Standard Deviation|Mean
2777832|NCT00686517|Secondary|Number of Participants With Rapid Virologic Response (RVR)|"Participants were considered to have RVR if serum HCV RNA level at 2 or 4~weeks of treatment was below the cut off value of the referring local~laboratory of each participating site."|Evaluated at 2 and 4 weeks of treatment|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
2777798|NCT00686595|Secondary|Percent Reduction in Affected BSA at Week 24|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant's body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the BSA assessment was available.|||Percent reduction||Standard Deviation|Mean
2777799|NCT00686595|Secondary|Percent Reduction in Affected Body Surface Area (BSA) at Week 18|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant's body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the BSA assessment was available.|||Percent reduction||Standard Deviation|Mean
2777800|NCT00686595|Secondary|Percent Reduction in SAPASI at Week 24|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SAPASI assessment was available.|||Percent reduction||Standard Deviation|Mean
2777801|NCT00686595|Secondary|Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SAPASI assessment was available.|||Percent reduction||Standard Deviation|Mean
2777802|NCT00686595|Secondary|PASI 100 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.|24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777803|NCT00686595|Secondary|PASI 100 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777804|NCT00686595|Secondary|PASI 100 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777805|NCT00686595|Secondary|PASI 90 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777806|NCT00686595|Secondary|PASI 90 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777807|NCT00686595|Secondary|PASI 90 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777808|NCT00686595|Secondary|PASI 50 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777809|NCT00686595|Secondary|PASI 50 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777810|NCT00686595|Secondary|PASI 50 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777811|NCT00686595|Secondary|PASI 75 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777812|NCT00686595|Secondary|PASI 75 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.|||Percent of participants|||Number
2777813|NCT00686595|Primary|Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.|||Percentage of participants|||Number
2777814|NCT00686582|Secondary|Number of Participants With Solicited General Adverse Events|Number of participants with solicited general AEs (body temperature increased, headache, myalgia, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with a completed diary card.|within 8 days after vaccination|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.|||Participants|||Count of Participants
2777815|NCT00686582|Secondary|Number of Participants With Solicited Local Adverse Events|Number of participants with and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritis). Percentages based on subjects with a completed diary card.|within 8 days after vaccination|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.|||Participants|||Count of Participants
2777816|NCT00686582|Secondary|Number of Participants With Related Grade >= 3 Unsolicited Adverse Events|Number of participants with Grade >=3 Unsolicited Adverse Event probably, possibly, or definitely related to the study vaccine|within 29 days after vaccination|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.|||Participants|||Count of Participants
2777817|NCT00686582|Secondary|Number of Participants With Unsolicited Non-serious Adverse Events|Number of participants with any, grade >=3, and related non-serious unsolicited adverse events|within 29 days after any vaccination|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.|||Participants|||Count of Participants
2777818|NCT00686582|Secondary|Number of Participants With Related Serious Adverse Events|Number of participants with Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine|within 26 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Subjects from Group 4 had a blood draw at Screening only, did not receive a booster dose and adverse events were not monitored/assessed for this group.|||Participants|||Count of Participants
2777819|NCT00686582|Secondary|Correlation PRNT vs ELISA Titers|Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers|within 26 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.|||Pearson correlation coefficient|||Number
2777821|NCT00686582|Secondary|Booster Rate by PRNT (Percentage of Participants)|"Booster rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects.~Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4).~Percentages based on number of subjects with data available."|within 26 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.|||percentage of subjects||95% Confidence Interval|Number
2777822|NCT00686582|Secondary|ELISA GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.|within 26 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.|||Titer||95% Confidence Interval|Geometric Mean
2777823|NCT00686582|Secondary|Booster Rate by ELISA (Percentage of Participants)|Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 26 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.|||percentage of subjects||95% Confidence Interval|Number
2777824|NCT00686582|Primary|Individual Peak Booster Rate by ELISA (Percentage of Participants)|Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.|within 4 weeks|Full Analysis Set/ Booster Set i.e., all subjects having received a booster dose in POX-MVA-023. Thus, Group 4 is not included.|||percentage of subjects||95% Confidence Interval|Number
2777825|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
2777826|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15|Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
2777827|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
2777828|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||Participants|||Number
2777829|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||ng/mL||90% Confidence Interval|Mean
2777830|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 2, 3, and 8.|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).|||ng/mL||90% Confidence Interval|Mean
2777831|NCT00686517|Secondary|Number of Peripheral Blood Mononuclear Cells (PBMCs)|Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.|Treatment Weeks 2, 4, 8, and 12|The association between HCV specific immune and SR to be assessed applying descriptive methods could not be evaluated as PBMC measurements were not carried out.||||||
2777833|NCT00686517|Secondary|Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization|ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.|Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
2777834|NCT00686517|Secondary|Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).|LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.|At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
2777835|NCT00686517|Secondary|Virologic Response at the End of Treatment Follow-up (ETR)|"ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks~treatment (depending on treatment arm) was <15 IU/mL."|At the end of treatment (either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
2777836|NCT00686517|Primary|Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period|SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.|Evaluated at the end of 6 months|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.|||participants|||Number
2777837|NCT00686374|Secondary|Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time|The CDAI includes 8 variables: participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease) and > 450 (severely active disease). A CDAI was calculated at each visit for those who were ≥ 13 years old at Study M06-806 entry. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||units on a scale||Standard Deviation|Mean
2777838|NCT00686374|Secondary|Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||units on a scale||Standard Deviation|Mean
2777839|NCT00686374|Secondary|Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time|The CDAI includes 8 variables encompassing subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and > 450 (severely active disease). A CDAI was calculated at each visit for subjects ≥ 13 years old at M06-806 entry. CDAI corticosteroid-free remission was defined as discontinued use at least 90 consecutive days prior to the respective visit and a CDAI < 150 at that visit.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|Participants ≥ 13 years old with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
2777840|NCT00686374|Secondary|Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384|Participants with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
2777841|NCT00686374|Secondary|Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time|The CDAI includes 8 variables: subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight). Participants kept track of symptoms on a diary card, and scores were summed for the week. Each item is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. Scale: < 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and > 450 (severely active disease). A CDAI was calculated at each visit for participants ≥ 13 yrs old at M06-806 entry. Clinical response was defined as a decrease from M06-806 Baseline CDAI value of ≥ 70 pts. The M06-806 Baseline value was defined as the last non-missing value on or before the date of the 1st dose of study drug in M06-806.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
2777842|NCT00686374|Secondary|Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time|The CDAI includes 8 variables encompassing both subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept track of daily symptoms on a diary card, and the daily symptom scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease. A CDAI was calculated at each visit for participants who were age 13 or older at Study M06-806 entry. The Study M06-806 Week 52 visit served as the baseline visit for this study.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
2777843|NCT00686374|Primary|Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The baseline PCDAI value was defined as the last non-missing value on or before the date of the first dose of study drug during Study M06-806. Clinical response was defined as a PCDAI ≥ 15 points lower than the Study M06-806 baseline PCDAI value.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
2777844|NCT00686374|Primary|Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.|Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408|ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.|||Participants|||Count of Participants
2777845|NCT00686335|Primary|Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment|Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.|4 weeks and 8 weeks|The efficacy analysis population included all 7 patients who completed both study periods without major protocol deviations.|||number of nocturnal awakenings||Standard Deviation|Mean
2777846|NCT00686257|Secondary|In-hospital Mortality Rate||during hospitalization (after recruitment)||||Participants|||Count of Participants
2777847|NCT00686257|Secondary|Length of Hospital Stay||during hospitalization (after recruitment)||||Days||Full Range|Mean
2777848|NCT00686257|Secondary|Total Length of Time Requiring NIV||during hospitalization (after recruitment)||||Hours||Inter-Quartile Range|Median
2777849|NCT00686257|Secondary|Deterioration in Gas Exchange||during the first 24 hours of the study||||Participants|||Count of Participants
2777850|NCT00686257|Secondary|Deterioration Vital Signs||during the first 24 hours of the study||||Participants|||Count of Participants
2777851|NCT00686257|Secondary|Early NIV Discontinuation Rate|Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support|During hospitalization period (after recruitment into the study)||||Participants|||Count of Participants
2777852|NCT00686257|Primary|Time Required for Mask Placement||at the initiation of NPPV||||Minutes||Inter-Quartile Range|Median
2777853|NCT00686257|Primary|Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)||During the first 3 hours of recruitment|By power analysis|||units on a scale||Standard Error|Mean
2777866|NCT00686075|Secondary|Genotypic Stability of Recovered Vaccine-Type Virus|Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.|Within 28 days after any dose|Shedding population included all randomized participants who received study vaccine and had valid shedding data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nasal wash samples|Participants||Number
2777854|NCT00686231|Primary|Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)|Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process. To compare combination of (Lidocaine + Nitroglycerin) or (Lidocaine + placebo), at visit 2, participants randomized to Comparison A received 30mg NTG + 20mg Lidocaine on one wrist, and placebo + 20mg Lidocaine on the other wrist; participants randomized to Comparison B received 30mg Nitroglycerin + 40mg Lidocaine on one wrist, and placebo + 40mg Lidocaine on the other wrist.|Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2|10 participants (20 wrists) received 30mg NTG + 20mg Lidocaine on one wrist, and placebo + 20mg Lidocaine on the other wrist; 9 participants (18 wrists) received 30mg NTG + 40mg Lidocaine on one wrist, and placebo + 40mg Lidocaine on the other wrist.|||percent diameter change|Radial Artery|Standard Deviation|Mean
2777855|NCT00686231|Primary|Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin|Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.|Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1|19 participants were randomized to receive 15mg (n=12) or 30mg (n=7) nitroglycerin on one wrist, and placebo on the other|||percent diameter change|radial artery (wrist)|Standard Deviation|Mean
2777856|NCT00686205|Primary|PRISM HIV O Plus Test Data for Sensitivity|Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).|12 months|1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.|||participants|||Number
2777857|NCT00686205|Primary|PRISM HIV O Plus Test Data for Specificity|Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.|12 months|The analysis was per the protocol.|||participants|||Number
2777858|NCT00686166|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.|Only adverse events that are possibly, probably or definitely related to study regimen are reported.|Up to 4 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
2777859|NCT00686166|Secondary|3-year Disease-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|3 years|Eligible and analyzable patients|||percentage of participants||95% Confidence Interval|Number
2777860|NCT00686166|Primary|Pathologic Complete Response Rate|Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.|15-20 weeks from registration|Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.|||percentage of participants||95% Confidence Interval|Number
2777861|NCT00686127|Secondary|Pain Interference With Function||12 weeks|||||||
2777862|NCT00686127|Primary|Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks|Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).|Baseline, 12 weeks|This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.|||units on a scale|||Number
2777863|NCT00686075|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.|||participants|||Number
2777864|NCT00686075|Secondary|Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization|An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.|||participants|||Number
2777865|NCT00686075|Secondary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.|||participants|||Number
2777867|NCT00686075|Secondary|Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3|Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.|Day 28 after Dose 3|Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and ‘n’ = participants evaluable for specified virus type, for each group, respectively.|||percentage of participants||95% Confidence Interval|Number
2777868|NCT00686075|Secondary|Number of Participants Who Shed Vaccine-Type Virus|Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.|7, 12 and 28 days after Dose 1, 2 and 3|Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. ‘N’ (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.|||participants|||Number
2777869|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
2777870|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
2777871|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
2777872|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
2777873|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
2777874|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
2777875|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
2777906|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||participants|||Number
2777876|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
2777877|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
2777878|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 3|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.|||participants|||Number
2777879|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 2|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.|||participants|||Number
2777880|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 1|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.|||participants|||Number
2777881|NCT00686036|Secondary|Serum Testosterone Levels||Change from baseline at each visit post-randomization until until week 78|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
2777882|NCT00686036|Secondary|Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)||From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
2777883|NCT00686036|Secondary|Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||78 weeks during off-treatment phase of ADT|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
2777884|NCT00686036|Primary|Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||52 weeks|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.||||||
2777885|NCT00685945|Other Pre-specified|Net Glucose Uptake|Individual net reuptake rates at each time point were calculated by the following formula: net uptake = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of glucose in the brachial vein and artery, respectively.|At baseline and after maximum dose of bradykinin||||microgram/min/100ml||Standard Error|Mean
2777886|NCT00685945|Secondary|Forearm Blood Flow (FBF)|Forearm blood flow was measured by strain gauge plethysmography|During and after each study drug administration||||ml/min/100ml||Standard Error|Mean
2777887|NCT00685945|Primary|Net Tissue-type Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively.|During and after each study drug administration|Twenty four subjects were studied. One subject was excluded because of erroneous drug administration. Analysis was per protocol. Twenty-three subjects receive bradykinin then L-NMMA plus bradykinin infusions. Subjects were then randomized to either isosorbide or sildenafil. Twelve subjects received sildenafil and 11 subjects received isosorbide.|||ng/min/100ml||Standard Error|Mean
2777888|NCT00685932|Primary|The Degree of Pain With Activity on Post-operative Day Number Two|Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.|2 days||||cm||Standard Deviation|Mean
2777889|NCT00685932|Secondary|Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery|Visual analog scale will be used to assess pain on the right or left side of the body with activity.VAS will use a 0-7.5cm range on the right and 0-7.5cm range on the left. This scale is with 0 (or central mark) as no pain and increasing as the subject marks away from the central mark.|2 days post-operation||||participants|||Number
2777890|NCT00685880|Primary|Number of Participants With a Decreased Pain Score >20%|Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.|baseline, 6 month follow-up|||||||
2778161|NCT00683904|Secondary|Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||ng/mL||Standard Deviation|Geometric Mean
2777891|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|Pharmacokinetic analyses of cilostazol and Pletal® are based on 28 and 27 subjects, respectively. Reliable estimates could not be obtained for one subject administered Cilostazol and two subjects administered Pletal® because there was not a smooth decline in concentrations in the terminal phase of elimination.|||ng-hr/mL||Standard Deviation|Mean
2777892|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
2777893|NCT00685802|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.||||ng/mL||Standard Deviation|Mean
2777894|NCT00685763|Secondary|Collect and Analyze Tumor Control Measures||1 year following the completion of radiation therapy|||||||
2777895|NCT00685763|Primary|Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)||1 year following the completion of radiation therapy||||participants|||Number
2777896|NCT00685750|Primary|Number of Patients Responding to Treatment, by Best Clinical Response Type|This outcome was assessed for metastatic melanoma patients treated with ipilimumab, in order to explore the predictive value to clinical activity of pre-identified immune-related gene-expression signature, by evaluating the patient's best clinical response to this treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|At 6 months after the initiation of the ipilimumab therapy|The analysis was performed on all the 25 subjects in the ME6 group that were tested for GS expression at Visit 1.|||Participants|||Count of Participants
2777897|NCT00685750|Primary|Number of NSCLC Patients With Gene-expression Signature and Tumor Antigens in Distinct Concomitant Tumor Lesions Obtained at the Same Time From the Same Patient.||After administration of standard of care treatment course|The testing was not be performed, because, as a consequence of the early study termination, no scientific value would have been brought and no patient would have benefited from it.||||||
2777898|NCT00685750|Primary|Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.||After administration of standard of care treatment course|The testing was not be performed, because, as a consequence of the early study termination, no scientific value would have been brought and no patient would have benefited from it.||||||
2777899|NCT00685750|Primary|The Serum Proteome||After administration of standard of care treatment course|Proteome analysis on serum samples was not performed, because they, as a consequence of the early study termination, would not have added any scientific value and would not have benefited any individual patient.||||||
2777900|NCT00685750|Primary|Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic|The outcome presents the number of participants with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic from before and after standard cancer treatment, for comparison.|Before and after administration of standard of care treatment course, up to 3 months|The analysis was performed on the Total Treated cohort. Data was not collected for the subjects in Non-Small Cell Group.|||Participants|||Count of Participants
2777901|NCT00685750|Primary|Number of Subjects With Expression of Tumor Antigens|The outcome presents the number of participants with expression of MAGE-A3 and NY-ESO-1 tumor antigens, after administration of standard of care treatment course compared to before administration|Before and after administration of standard of care treatment course, up to 3 months|The analysis was performed on the Total Treated cohort.|||Participants|||Count of Participants
2777902|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||participants|||Number
2777903|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||participants|||Number
2777904|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|Number at Test of Cure Visit, ITT population|||participants|||Number
2777905|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|Number at the End of Treatment/Early Termination Visit, ITT population|||participants|||Number
2777910|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||scores on a scale||Standard Deviation|Mean
2777911|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||scores on a scale||Standard Deviation|Mean
2777912|NCT00685698|Secondary|Total Wound Score (at Test of Cure in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||scores on a scale||Standard Deviation|Mean
2777913|NCT00685698|Secondary|Total Wound Score (at Test of Cure in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||scores on a scale||Standard Deviation|Mean
2777914|NCT00685698|Secondary|Per-Pathogen Microbiological Responses|Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||percentage of participants||95% Confidence Interval|Number
2777915|NCT00685698|Secondary|Per-Pathogen Clinical Response (at End of Treatment/Early Termination)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||percentage of participants||95% Confidence Interval|Number
2777916|NCT00685698|Secondary|Per-Pathogen Clinical Responses (at Test of Cure)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||percentage of participants||95% Confidence Interval|Number
2777917|NCT00685698|Secondary|Clinical Success (at End of Treatment/Early Termination)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)||||percentage of participants||95% Confidence Interval|Number
2777918|NCT00685698|Secondary|Clinical Success (in PP Population)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1), and adhered to the protocol without major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2777919|NCT00685698|Secondary|Microbiological Success Rate|"Microbiological Success~Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit.~Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site.~TOC=Test of Cure"|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination||||percentage of participants||95% Confidence Interval|Number
2778376|NCT00682786|Post-Hoc|Toxicities by Genotype Group (Good Risk Versus Poor Risk)|Grade 3 to 4 toxicities related to treatment and surgery using CTC Version 2.0.|First day of treatment through 30 days after completion of surgery|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
2777920|NCT00685698|Primary|Clinical Success (in ITT Population)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1).|||percentage of participants||95% Confidence Interval|Number
2777921|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|54 subjects were enrolled and 51 subjects completed the study. Lovastatin plasma concentration data for 48 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 3 subjects. Mevacor® plasma concentration data for 50 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 1 subject.|||ng-hr/mL||Standard Deviation|Mean
2777922|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
2777923|NCT00685685|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.|||ng/mL||Standard Deviation|Mean
2777924|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|24 months (approximately study days 547 - 730)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777925|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|18 months (approximately days 366 - 546)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777926|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|12 months (approximately study days 271 - 365)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777927|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|9 months (approximately study days 181 - 270)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777928|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|6 months (approximately study days 91 - 180)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777929|NCT00685659|Primary|Percent Days Abstinent|Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine|3 months (approximately study days 1 - 90)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777930|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|24 months (approximately study days 547 - 730)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777931|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|18 months (approximately study days 366 - 546)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777932|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|12 months (approximately study days 271 - 365)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777933|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|9 months (approximately study days 181 - 270)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777934|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|6 months (approproximately study days 91 - 180)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2777935|NCT00685659|Primary|Percent Days Cocaine Use|Percent of days during the follow up that there was any cocaine use|3 months (approximately study days 1 - 90)|N's represent the participants at three months for whom complete Time Line Follow Back data was available.|||percentage of days||Standard Error|Mean
2778377|NCT00682786|Secondary|Determine Patient Fears and Expectations of Pharmacogenetics.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy|The data was not collected for this outcome measure as the questionnaire was encouraged but not required.||||||
2777936|NCT00685659|Secondary|HIV Sex Risk Score|Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.|24 months|N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery).|||units on a scale||Standard Deviation|Mean
2777937|NCT00685659|Secondary|HIV Sex Risk Score|Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.|12 months|N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery).|||units on a scale||Standard Deviation|Mean
2777938|NCT00685659|Secondary|Participation in Protocol|Percent available sessions completed|24 months|Participants in TAU did not receive telephone counseling so were not included in these analyses. N's for TMAC and TMAC Plus represent participants who completed orientation.|||percentage of sessions||Standard Deviation|Mean
2777939|NCT00685659|Primary|Net Comparisons of Savings and Spendings Across Groups From Societal Perspective|Savings minus intervention costs. Presented in 2008 dollars.|24 months||||US Dollars||Standard Deviation|Mean
2777940|NCT00685659|Primary|Net Saving/Spending Comparisons Across Groups From Provider Perspective|Savings minus intervention costs. Presented in 2008 dollars.|24 months||||US Dollars||Standard Deviation|Mean
2777941|NCT00685659|Primary|Comparison Across Groups in Societal Costs|Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.|24 months||||US Dollars||Standard Deviation|Mean
2777942|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|24 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 24.|||proportion of participants positive|||Number
2777943|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|18 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 18.|||proportion of participants positive|||Number
2777944|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|12 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 12.|||proportion of participants positive|||Number
2777945|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|9 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 9.|||proportion of participants positive|||Number
2777946|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|6 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 6.|||proportion of participants positive|||Number
2777947|NCT00685659|Primary|Cocaine Urine Toxicology|Positive cocaine test of urine|3 month follow up|The N analyzed represents the number of participants for whom we had UDS results in month 3.|||proportion of participants positive|||Number
2777948|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|24 month follow up|The N analyzed represents the number of participants we were able to reach for 24 month follow up.|||participants|||Number
2777949|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|18 month follow up|The N analyzed represents the number of participants we were able to reach for the 18 month follow up.|||participants|||Number
2777950|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|12 month follow up|The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation.|||participants|||Number
2777951|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|9 month follow up|The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation.|||participants|||Number
2777952|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|6 month follow up|The N analyzed represents that number of participants we reached for 6 month follow up evaluation.|||participants|||Number
2777953|NCT00685659|Primary|Abstinence|Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.|3 month follow up|The N analyzed represents that number of people we reached for three month follow up evaluation.|||participants|||Number
2777954|NCT00685516|Secondary|Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).||6 weeks|Pre and post blood samples unavailable for: 4 participants in Arm I (GT group), 3 participants in Arm II (control/water group) and 3 participants in Arm III (BT group).|||ng/mL||Standard Deviation|Mean
2777955|NCT00685516|Secondary|Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).|Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption|6 weeks|"Urine concentration of (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."|||umol/g creatinine||Standard Deviation|Mean
2777956|NCT00685516|Secondary|Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue|Examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.|6 weeks|"Concentration of tea polyphenols and methyl-metabolites in prostate tissue after the consumption of GT and BT. No polyphenols were found after water consumption.~(-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."|||(pmol/g tissue)||Standard Deviation|Mean
2777957|NCT00685516|Primary|Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.|To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.|6 weeks|subjects that completed study|||percent positive of total cells||Standard Deviation|Mean
2777958|NCT00685477|Secondary|Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method||15, 30, 45 and 60 minutes post-infusion|Some participants were excluded from analyses due to location testing procedures|||percentage||Standard Deviation|Mean
2777959|NCT00685477|Primary|Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method|The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.|15, 30, 45, and 60 minutes post drug infusion|Some participants were excluded from analyses due to location testing procedures|||percentage||95% Confidence Interval|Number
2777960|NCT00685399|Secondary|Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs|"A flare was defined as an increase of inflammation in either eye so that the anterior chamber cell score or the vitreous haze score become 1+ or greater. Vitreous haze was evaluated with an indirect ophthalmoscope and a hand-held 20-diopter lens. Haze is defined as a reduction in the clarity of fundus details seen through the vitreous, the degree of haze was quantified using standard National Eye Institute (NEI) photographs. The standard photographs provide a grading scale with photographs of fundi with vitreous haze grades 0 (zero), trace (which counts as 0.5+), 1+, 2+, 3+, and 4+. If the amount of vitreous haze appears to fall between two integer grades, the value would be recorded as halfway between the grades. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results."|Day 1 to Day 57|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
2777961|NCT00685399|Secondary|Number of Participants With Remission in Uveitis|Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes after the first course of one or two doses by Day 57 visit . The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Baseline (Day 1) up to Month 8|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
2777962|NCT00685399|Secondary|Number of Participants Who Were Able to Induce a Remission in Uveitis|Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes by Day 57 visit after the first course of one or two doses of AIN457 were to be categorized as nonresponders and were to be discontinued from the study at the Day 85 visit. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Day 1 to Day 85|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
2777973|NCT00685334|Primary|Tolerability|This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication.|Measured at Week 12|Data was not available for all 22 participants.|||Participants|||Number
2777974|NCT00685334|Primary|Change From Baseline in Weight (Lbs.) at 12 Weeks|This study looked at change in weight before and after medication use.|baseline and 12 weeks||||lbs||Standard Deviation|Mean
2777963|NCT00685399|Secondary|Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs|Participants intake of oral prednisone or topical corticosteroid and other immunosuppressant drugs was reduced if participant was on up to 1.5 mg/kg/day dose of prednisone during the week prior to Day 1 or whom the resumption of prednisone was not considered the appropriate systemic therapy by investigator or who have never been on systemic immunosuppressive therapy and whose uveitis was so severe that, in the clinician's judgment, prednisone at a dose of 1.0-1.5 mg/kg/day alone will be insufficient to control the uveitis or participant with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.|Baseline (Day 1) up to Month 8|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.||||||
2777964|NCT00685399|Secondary|Number of Complete Responders in Cohort 2, 3 and 6 at Day 57|"A complete responder was defined as a participant who was able to stop all topical and systemic corticosteroids in both eyes and maintain remission of uveitis (=remains a responder as defined above) lasting at least 1 week (since stopping corticosteroids, if corticosteroids were given)."|Day 1 (Baseline), Day 57|PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||Participants|||Number
2777965|NCT00685399|Secondary|Number of Responders in Cohort 1, 2, 3 and 6 at Day 57|"A responder was defined as a participant who fulfilled at least one of the 3 criteria compared to baseline: 1. Increase in visual acuity by at least 15 letters using Early Treatment Diabetic Retinopathy Study method, no increase in daily prednisone dose compared to week 1 and without worsening of uveitis. 2. Decrease in vitreous haze by 2 steps or more or for participants with anterior uveitis, resolution of the anterior chamber inflammation (i.e., no cells or only a rare cell in the anterior chamber (score 0 or trace (0.5+)), use measurement before dilation), no increase in daily prednisone dose compared to week 1 and without any worsening of uveitis.3 For those participant on a. >20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 10 mg/day or less. b. ≤20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 0 mg/day. c. topical corticosteroids during week 1: Reduction in daily topical corticosteroid dose to 0 during the last 2 weeks."|Day 1 (Baseline), Day 57|The Per Protocol Analysis Set (PPAS) consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.|||Participants|||Number
2777966|NCT00685399|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Day 603|Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug and had at least one post–baseline safety assessment. All safety evaluations were carried out on the safety analysis set.|||participants|||Number
2777967|NCT00685373|Secondary|Pharmacokinetics|Mean Clearance from serum in Liter per Day (CLD) in adult participants >=18, pediatric participants <18 with body weight >40 kg and pediatric participants <18 with body weight <=40 kg.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety population defined as all participants who received at least 1 dose of study drug. 3 participants were excluded because dosing information was not available at the time of analysis.|||L/day||Standard Deviation|Mean
2777968|NCT00685373|Secondary|Immunogenicity of Canakinumab (ACZ885)|The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who received at least one dose of study drug and were tested for anti-ACZ885 antibodies at the end of the study.|||participants|||Number
2777969|NCT00685373|Secondary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers.|"Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal.~Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe."|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who had at least one dose of study drug and were included in the Relapse Assessment.|||Percentage of participants|||Number
2777970|NCT00685373|Primary|The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions|The number of participants with Adverse Events and Infections & Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions.|2 years depending on when the participant enters the study|Safety Population defined as all participants who received at least one dose of study drug.|||participants|||Number
2777971|NCT00685334|Secondary|Treatment Compliance|Total number of randomized patients that completed the full 12 weeks of treatment.|Measured at Week 12|||||||
2777975|NCT00685295|Secondary|Occurrence of Untoward Opioid Side Effects|Subjects were monitored for any signs of untoward opioid side effects.|120 minutes||||Participants|||Count of Participants
2777978|NCT00685178|Secondary|Voucher Earnings|"Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20.~Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence"|12 weeks (Weeks 8-20)||||Dollars||Standard Error|Mean
2777979|NCT00685178|Primary|Proportion of Cocaine Positive Urine Samples Per Treatment Condition|Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)|Urine samples collected 3 times weekly from week 1 through 26|This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.|||percentage of positive urine samples|||Number
2777980|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.|||ng-hr/mL||Standard Deviation|Mean
2777981|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.|||ng-hr/mL||Standard Deviation|Mean
2777982|NCT00685165|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.|||ng/mL||Standard Deviation|Mean
2777983|NCT00685139|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
2777984|NCT00685139|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 33 out of 34 subjects who completed this study. One subject elected to withdraw prior to the study hour 2 blood sample collection during period II.|||ng/mL||Standard Deviation|Mean
2777985|NCT00685035|Secondary|Patients' Perceived Comfort Using the Different Settings for the Vest Device|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable). Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."|Immediately following each airway clearance therapy on day 1 and day 4|power calculation not performed for secondary outcomes|||units on a scale||Full Range|Median
2777986|NCT00685035|Secondary|Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1-100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."|Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4|power calculation not performed for secondary outcomes|||dynes/cm^2||Full Range|Median
2777987|NCT00685035|Secondary|Pre vs. Post Therapy Spirometry|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.|Prior to and following each airway clearance therapy session on days 1 and 4|Power calculation not performed for secondary outcomes.|||ml||Standard Deviation|Mean
2778020|NCT00684762|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.|||ng/mL||Standard Deviation|Mean
2777988|NCT00685035|Primary|Sputum Wet and Dry Weight|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum dry weight was calculated after re-weighing the container."|Produced during each airway clearance therapy session on days 1 and 4|In a previous study with similar design,21 the standard deviation for the difference in the mean sputum wet weight between treatment arms was 4.6 g. Assuming the same standard deviation for the current study, enrollment of 16 subjects provided an 80% chance of detecting a 3.5-g difference in the sputum wet weights at a significance level of .05.|||grams||Full Range|Median
2777989|NCT00684996|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2777990|NCT00684996|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST), Including Confirmed and Unconfirmed Complete and Partial Responses (Phase II)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
2777991|NCT00684996|Primary|Overall Survival (Phase II)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|From date of registration to date of death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
2777992|NCT00684996|Primary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 (Phase II)|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
2777993|NCT00684996|Primary|Progression-free Survival (Phase II)|Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
2777994|NCT00684996|Primary|Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)||Up to 8 weeks|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.||||||
2777995|NCT00684983|Secondary|Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0)|"All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.~4/19 (21.05%) 14/45 (31.11%)"|Baseline to 30 days past end of treatment||||percentage of patients with AEs|||Number
2777996|NCT00684983|Secondary|Duration of Response|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|Up to 5 years|Evaluable patients that had a response to treatment drug|||Months||Full Range|Median
2777997|NCT00684983|Secondary|Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years|Includes patients with at least one disease assessment at least 6 weeks after registration.|||% of evaluable participants||95% Confidence Interval|Number
2777998|NCT00684983|Secondary|Time to Treatment Failure|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years||||Months||Full Range|Median
2777999|NCT00684983|Secondary|Overall Survival|Median Survival time (months)|From randomization to death due to any cause, up to 5 years|All evaluable patients|||Months||Full Range|Median
2778000|NCT00684983|Primary|Progression-free Survival (PFS)|Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.|From randomization to the earliest date of documentation of disease progression, up to 5 years|First 8 patients in Arm B are from safety cohort, they are not eligible for primary end point|||Median survival and CI in months||95% Confidence Interval|Median
2778021|NCT00684749|Secondary|Surgeon Satisfaction With Outcome|Patient completedsurvey regarding outcome|1 Year|||||||
2778022|NCT00684749|Secondary|Patient Satisfaction With Outcome|Patient completed a survey regarding outcome|1 Year|||||||
2778023|NCT00684749|Primary|Reoperation Rates|Surgeon completed survey|2 years|All patients who were treated in the time period|||participants|||Number
2778001|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.|||ng-hr/mL||Standard Deviation|Mean
2778002|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.|||ng-hr/mL||Standard Deviation|Mean
2778003|NCT00684814|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.|||ng/mL||Standard Deviation|Mean
2778004|NCT00684788|Secondary|HIV Risk Behaviors|Went to a crack house|4 months||||percentage of months reported||Standard Deviation|Mean
2778005|NCT00684788|Secondary|Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine|Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100|18 weeks|intent to treat|||percentage of cocaine negative||Full Range|Mean
2778006|NCT00684788|Secondary|Percentage of 30-day Assessments Urine Samples Negative for Cocaine|(The number of urine samples that were negative for cocaine/total number of urine samples)x 100|4 months||||percentage of cocaine negative||Full Range|Mean
2778007|NCT00684788|Secondary|Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates|Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100|18 weeks||||percentage of opiate negative||Full Range|Mean
2778008|NCT00684788|Secondary|Percentage of 30-day Assessments Urine Samples Negative for Opiates|(The number of urine samples that were negative for opiates/total number of urine samples)x 100|4 months||||percentage of opiate negative||Full Range|Mean
2778009|NCT00684788|Secondary|The Time to the First Missed Dose of Depot Naltrexone|The number of weeks until the first missed dose of depot naltrexone|18 weeks||||weeks||Standard Deviation|Mean
2778010|NCT00684788|Primary|Percentage of Depot Naltrexone Doses Received|The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.|18 Weeks||||percentage of injections||Full Range|Mean
2778011|NCT00684775|Secondary|Percentage of M,W,F Urine Samples Negative for Opiates|Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates|Collected every Monday, Wednesday and Friday for 24 weeks|intent to treatment|||percentage of opiate negative||Full Range|Mean
2778012|NCT00684775|Secondary|HIV Risk Behaviors|behaviors that place participants at risk for acquiring or transmitting HIV infection|24 weeks||||percentage of months reported||Standard Deviation|Mean
2778013|NCT00684775|Secondary|Average Percentage of 30-day Urine Samples Negative for Cocaine|The percentage of urine samples collected at 30-day assessments that are negative for cocaine.|Collected every 30 days for 150 days|intent to treat|||percentage cocaine negative urine sample||Full Range|Mean
2778014|NCT00684775|Secondary|Percentage of M-W-F Samples Negative for Cocaine|Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine|Collected every Monday, Wednesday and Friday for 24 weeks|intent to treat|||percentage of mwf cocaine negative||Full Range|Mean
2778015|NCT00684775|Secondary|Percentage of 30-day Urine Samples Negative for Opiates|Percentage of urine samples collected at the 30-day assessments that are negative for opiates|Collected every 30 days for 150 days|intent to treat|||percentage of opiate negative||Full Range|Mean
2778016|NCT00684775|Primary|Time to the First Missed Dose|The time to the first missed dose of depot naltrexone|24 weeks||||weeks||Standard Deviation|Mean
2778017|NCT00684775|Primary|Naltrexone Injections Received|The percentage of depot naltrexone doses that participants received|24 weeks|intent-to-treat|||Percentage of injections received||Full Range|Mean
2778018|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable cilostazol (reference and test) plasma concentration to the elimination rate constant.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 26 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used. Additionally, two subjects had data values that were not used in this analysis.|||ng-hr/mL||Standard Deviation|Mean
2778019|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable cilostazol (test and reference) concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.|||ng-hr/mL||Standard Deviation|Mean
2778024|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
2778025|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng-hr/mL||Standard Deviation|Mean
2778026|NCT00684723|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng/mL||Standard Deviation|Mean
2778027|NCT00684671|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|During one month following the administration of the challenge dose||||Participants|||Count of Participants
2778028|NCT00684671|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)||||Participants|||Count of Participants
2778029|NCT00684671|Secondary|Number of Subjects Reporting Unsolicited Symptoms|"Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 31-day follow-up period after the challenge dose.||||Participants|||Count of Participants
2778030|NCT00684671|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).|During the 4-day follow-up period after the challenge dose.||||Participants|||Count of Participants
2778031|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Two weeks and one month after the challenge dose|Analysis was performed on the Log-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2778032|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Prior to administration of challenge dose|Analysis was performed on the Long-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2778033|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|"Anamnestic response was defined as :~for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL),~for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
2778034|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies|"Anamnestic response was defined as:~for initially seronegative subjects, antibody concentration greater than or equal the cut-off [≥ 15 Milli-International Units per Milliliter (mIU/mL)],~for initially seropositive subjects with pre-vaccination antibody, concentration < 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration,~for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
2778035|NCT00684645|Other Pre-specified|Percentage of Participants Responding to Treatment|Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.|12 months|All participants|||percentage of participants|||Number
2778036|NCT00684645|Other Pre-specified|Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade|Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL; Grade 3: Requiring >1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death.|Baseline up to 12 months|All participants|||percentage of participants|||Number
2778037|NCT00684645|Other Pre-specified|Summary of Adverse Events for Participants Who Required Dose Modification|Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.|Baseline up to 12 months|Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event.|||participants|||Number
2778038|NCT00684645|Primary|Percentage of Participants With Hypertension|Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.|Baseline, Week 6, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.|||percentage of participants|||Number
2778039|NCT00684645|Primary|Percentage of Participants With Hypothyroidism|TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point.|Baseline, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.|||percentage of participants|||Number
2778040|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.|Baseline to date of death (up to 12 months)|FAS|||participants|||Number
2778041|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).|Baseline to date of first documentation of response to treatment (up to 12 months)|FAS|||participants|||Number
2778042|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 12|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
2778043|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 9|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
2778044|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 6|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
2778045|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 3|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
2778046|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Week 6|FAS. Percentages based on entire FAS population.|||percentage of participants|||Number
2778047|NCT00684645|Primary|Overall Survival (OS)|OS is the duration from enrollment to death.|Baseline to date of death (up to 12 months)|FAS|||months||95% Confidence Interval|Median
2778048|NCT00684645|Primary|Progression-free Survival (PFS)|The period from study entry until disease progression, death, or date of last contact.|Baseline to measured progressive disease (up to 12 months)|FAS|||months||95% Confidence Interval|Median
2778049|NCT00684645|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 months|Full analysis set (FAS): all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
2778050|NCT00684593|Secondary|Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Tmax at Day 28.|||Hours||Full Range|Median
2778051|NCT00684593|Secondary|Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable for T1/2. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing. An additional 2 participants were excluded from the population because their T1/2 was incalculable.|||Hours||Standard Deviation|Mean
2778052|NCT00684593|Secondary|Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable at Day 28 for AUC (0-24). One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.|||hr*ng/mL||Standard Deviation|Mean
2778053|NCT00684593|Secondary|Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Cmax at Day 28. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.|||ng/mL||Standard Deviation|Mean
2778054|NCT00684593|Secondary|Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29|The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.|Day 29|The population consisted of all treated participants with follow-up.|||Participants|||Number
2778055|NCT00684593|Primary|Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29|PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).|Baseline and Day 29|The population consisted of all treated participants with follow-up.|||Score on a Scale||Standard Deviation|Mean
2778056|NCT00684567|Secondary|Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response|"CR = measurable lesion disappeared.~PR = total sum of lesions measurable in bidimension decreased by 50% or more on whole and no secondary progression attributable to tumor was noted. No onset of new lesion."|1 year after the start of administration in the concomitant radiotherapy phase|Response rate in terms of tumor response (ratio of CR + PR) in 19 participants was assessed by Efficacy and Safety Evaluation Committee. 19 participants were found to have measurable lesions. Nineteen participants (as opposed to 30 participants) were analyzed because that is how many participants were still alive 1 year after start of therapy.|||Participants|||Number
2778057|NCT00684567|Secondary|Number of Participants With Progression Free Survival (PFS) for 1 Year|Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).|1 year after the start of admininstration in the concomitant radiotherapy phase||||Participants|||Number
2778058|NCT00684567|Primary|Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy||||Participants|||Number
2778059|NCT00684567|Primary|Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy||||Participants|||Number
2778060|NCT00684567|Primary|Adverse Events With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.|until 30 days after the completion of administration of monotherapy||||Participants|||Number
2778061|NCT00684554|Secondary|Prolonged Withdrawal|participants experiencing prolonged withdrawal beyond two days after buprenorphine induction|a) 2 days|participants who initiated induction|||participants|||Number
2778062|NCT00684554|Primary|The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.|The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.|one week after initial primary care visit|patients who in initiated induction|||participants|||Number
2778063|NCT00684541|Secondary|Social Phobia and Agoraphobia Inventory|Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.|Pre, Post (6 weeks), Followup (3 months after post-assessment)||||units on a scale||Standard Deviation|Mean
2778064|NCT00684541|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms.|Pre, Post (6 weeks), Followup (3 months after post-assessment)||||units on a scale||Standard Deviation|Mean
2778065|NCT00684515|Secondary|Mean Membrane-Bound P-Selectin Levels By Study Visit|Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had membrane-bound p-selectin data available.|||Arbitrary Units||Standard Error|Mean
2778066|NCT00684515|Secondary|Mean CD40 Ligand Levels By Study Visit|Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had CD40 ligand data available.|||mg/L||Standard Error|Mean
2778067|NCT00684515|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit|Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.|Up to Day 60|The population consisted of all enrolled participants who received at least one dose of study drug and had hs-CRP data available.|||mg/L||Standard Deviation|Median
2778068|NCT00684515|Secondary|Number of Participants With MACE or Death|The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.|||Participants|||Number
2778069|NCT00684515|Secondary|Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events|Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had TIMI bleeding data available.|||Participants|||Number
2778070|NCT00684515|Primary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.|||Participants|||Number
2778071|NCT00684424|Secondary|Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.|Baseline, Week 16 (Final Visit)|FAS. Abbreviations: BL = Baseline; FV = Final Visit.|||participants|||Number
2778072|NCT00684424|Secondary|Medical Outcomes Sleep Scale (MOS-S)|MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 16 (Final Visit )|FAS. A subscale was classified as missing if any of the questions used in the calculation were missing. Abbreviations: BL = Baseline, SOB = short of breath.|||scores on scales||Standard Deviation|Mean
2778073|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)|CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.|Week 16 (Final Visit)|FAS|||participants|||Number
2778074|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.|Baseline|FAS|||participants|||Number
2778075|NCT00684424|Secondary|Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.|Baseline, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.|||mm||Standard Deviation|Mean
2778076|NCT00684424|Secondary|Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.|Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.|||mm||Standard Deviation|Mean
2778077|NCT00684424|Secondary|Average Dosage of Pregabalin Taken at Baseline and Final Visit|Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.|Baseline, Week 16 (Final Visit )|Safety analysis set.|||participants|||Number
2778078|NCT00684424|Secondary|Concomitant Drug Treatments|Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.|Baseline through Week 16 (Final Visit)|Safety analysis set.|||participants|||Number
2778079|NCT00684424|Secondary|Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study|Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.|Week 8 up to Week 16 (Last 4 weeks of the treatment period)|FAS|||participants|||Number
2778080|NCT00684424|Secondary|Change in 28 Day Partial Seizure Frequency|Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.|Baseline through Week 16 (Final Visit )|FAS. Subjects who discontinued less than 4 weeks into the treatment period or with missing date of the attack were excluded from analyses.|||number of seizures per 28 days||Standard Deviation|Mean
2778081|NCT00684424|Secondary|Antiepileptic Drugs Used in the Past|Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.|Baseline|Safety analysis set: all subjects who received at least 1 dose of study medication.|||participants|||Number
2778082|NCT00684424|Primary|Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency|Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.|Baseline through Week 16|Full Analysis Set: all subjects who received at least 1 dose of study drug and had at least 1 efficacy measurement.|||participants|||Number
2778083|NCT00684411|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.|||days||90% Confidence Interval|Median
2778084|NCT00684411|Secondary|Progression-Free Survival|"Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Disease progression was assessed per International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].~Per International Working Group response criteria in lymphoma progressive disease (PD) was defined as the appearance of new lesions; the sum of the product of the diameter (SPD) increasing ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall; or, in any single nodal target lesion, a node with a short axis > 10 mm must increase > 50% in greatest transverse diameter or a node with short axis <10mm must increase by at least 50% to at least 15 mm x 15 mm or have a greatest transverse diameter greater than 15 mm."|Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.|||days||90% Confidence Interval|Median
2778105|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available.|||Participants|||Number
2778106|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available.|||ng/mL||Standard Error|Mean
2778085|NCT00684411|Primary|Overall Response Rate|"Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].~Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR.~."|Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.|||proportion of participants||90% Confidence Interval|Number
2778086|NCT00684320|Secondary|Social Phobia and Anxiety Inventory|Our primary self-report outcome measure was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), which consists of 45 items assessing the cognitive, behavioral, and somatic dimensions of SP. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. This measure has strong psychometric properties (Turner et al., 1989) and has been widely used in previous treatment outcome research in SP (e.g., Clark et al., 2006).|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)||||units on a scale||Standard Deviation|Mean
2778087|NCT00684320|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms|Pre-Treatment, Post-Treatment (6 weeks)||||units on a scale||Standard Deviation|Mean
2778088|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC|Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol||||L/h||Full Range|Median
2778089|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC|Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol||||L/h||Full Range|Median
2778090|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT|Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T|36 weeks according to protocol||||L/h||Full Range|Median
2778091|NCT00684307|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol||||nmol/L||Full Range|Median
2778092|NCT00684307|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol||||nmol/L||Full Range|Median
2778093|NCT00684307|Secondary|Ecarin Clotting Time (ECT)|Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)||||sec||Full Range|Median
2778094|NCT00684307|Secondary|Activated Partial Thromboplastin Time (APTT)|Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)||||sec||Full Range|Median
2778095|NCT00684307|Secondary|D-Dimer|Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)|14 weeks according to protocol.(enrolment to week 12 visit)||||ng/mL||Full Range|Median
2778096|NCT00684307|Primary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)||||Participants|||Number
2778097|NCT00684307|Primary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with ALAT>=3 times upper limit of normal.l|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)||||Participants|||Number
2778098|NCT00684307|Primary|Creatinine|Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)||||umol/L||Standard Deviation|Mean
2778099|NCT00684307|Primary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)||||Participants|||Number
2778100|NCT00684255|Secondary|Progression Free and Overall Survival.|Probability of progression free and overall survival will be measured.|1 year|||||||
2778101|NCT00684255|Secondary|Immune Reconstitution.|Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.|1 year|||||||
2778102|NCT00684255|Secondary|Chimerism|Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.|1 year|||||||
2778103|NCT00684255|Primary|Toxicity|Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.|1 year|||||||
2778104|NCT00684242|Primary|Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)|"Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 no symptom to 10 worst possible symptom."|From baseline to Day 15|One participant was not evaluable for Day 15.|||units on a scale|||Number
2778107|NCT00684203|Secondary|Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available.|||mg/L||Standard Deviation|Median
2778108|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.|Up to Day 30|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available.|||Participants|||Number
2778109|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available.|||Participants|||Number
2778110|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events|Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.|Up to 10 Hours Post-CABG|Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study.||||||
2778111|NCT00684203|Secondary|Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.|Up to Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available.|||Participants|||Number
2778112|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available.|||Participants|||Number
2778113|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data.|||Participants|||Number
2778114|NCT00684203|Secondary|Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available.|||Arbitrary Units||Standard Error|Mean
2778115|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available.|||ng/mL||Standard Error|Mean
2778116|NCT00684203|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit|Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available.|||mg/L||Inter-Quartile Range|Median
2778117|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit|Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60, Day 74, Day 90, Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available.|||Participants|||Number
2778127|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
2778118|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available.|||Participants|||Number
2778119|NCT00684203|Secondary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available.|||Participants|||Number
2778120|NCT00684203|Primary|Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI.|||Participants|||Number
2778121|NCT00684177|Secondary|Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)|"Therapeutic Success (Succ) was referred to as both Clinical Succ and Microbiological (Micro) Succ at Follow-up. Clinical Succ was the Resolution of baseline signs/symptoms of infection with a pus score of 0. A participant was Micro Succ if the micro outcome for all baseline pathogens (bps) belonged to Eradication (elimination of bps), Presumed Eradication (clinical outcome is success; no culturable material), or Colonization (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed Therapeutic Failures."|Follow-up (Days 12-14)|ITTB subset of Primary Efficacy Population|||participants|||Number
2778122|NCT00684177|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained."|Days 7-9|ITTB subset of Primary Efficacy Population|||baseline pathogens|||Number
2778123|NCT00684177|Secondary|Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)|Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.|Days 7-9|Primary Efficacy Population|||participants|||Number
2778124|NCT00684177|Secondary|Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The by subject microbiological response was Microbiological Success if the microbiological outcomes for all baseline pathogens (bps) belong to Eradication (elimination of bps), Presumed Eradication (clinical outcome was success; no culture was obtained due to lack of culturable material), or Colonization (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was Microbiological Failure."|Days 12-14|ITTB subset of Primary Efficacy Population|||participants|||Number
2778125|NCT00684177|Secondary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population|"Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|ITTB subset of Primary Efficacy Population: participants in the Primary Efficacy Population (see analysis population description in the Primary Outcome section) who had at least one pathogen isolated at the baseline visit.|||participants|||Number
2778126|NCT00684177|Primary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population|"Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|Primary Efficacy Population: ITTC participants (par.) with baseline pus/exudate >=3 who were enrolled under the original protocol with data captured under eCRF V1 and who were enrolled under protocol amendments with data captured under eCRF V2; ITTC (Intent-to-treat Clinical): all randomized par. who received at least one dose of study medication.|||participants|||Number
2778128|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
2778129|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
2778130|NCT00684138|Secondary|Binocular Distance Corrected Distance Visual Acuity|Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
2778131|NCT00684138|Primary|Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)|Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.|3 months|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).|||logMAR||95% Confidence Interval|Mean
2778132|NCT00684073|Primary|Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).|"Score of 0 = Not satisfied at all; Score of 10 = Totally satisfied"|Each treatment Day (post-dose on days 1-5)|Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.|||centimeters||Standard Deviation|Mean
2778133|NCT00684060|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|"Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4).~Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months."|||mm||Standard Deviation|Mean
2778134|NCT00684060|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included. One patient was excluded from the analysis due to incomplete signal intensity enhancement data.~Values reported represent the change in wall motion over time in the infarct zone from baseline to six months."|||mm||Standard Deviation|Mean
2778135|NCT00684060|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in infarct volume from baseline to six months."|||mL||Standard Deviation|Mean
2778136|NCT00684060|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end systolic volume index from baseline to six months."|||mL/m2||Standard Deviation|Mean
2778137|NCT00684060|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end diastolic index from baseline to six months."|||mL/m2||Standard Deviation|Mean
2778138|NCT00684060|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.)|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV mass from baseline to six months."|||g||Standard Deviation|Mean
2778139|NCT00684060|Secondary|Combined Endpoint|Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure. This is measured as the number of events by treatment group over the 6 month follow up period.|Measured at Baseline and Month 6|All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.|||events|||Number
2778140|NCT00684060|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in Global EF from baseline to six months."|||percentage of ejection fraction||Standard Deviation|Mean
2778143|NCT00684047|Primary|The Primary Efficacy Endpoint is Time to Hemostasis.|The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.|The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.||||percentage of subjects|||Number
2778144|NCT00684021|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|||mm||Standard Deviation|Mean
2778145|NCT00684021|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month MRI images available are included. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|||mm||Standard Deviation|Mean
2778146|NCT00684021|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in infarct volume from baseline to six months."|||mL||Standard Deviation|Mean
2778147|NCT00684021|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end systolic volume index from baseline to six months."|||mL/m2||Standard Deviation|Mean
2778148|NCT00684021|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end diastolic index from baseline to six months."|||mL/m2||Standard Deviation|Mean
2778149|NCT00684021|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV mass from baseline to six months."|||g||Standard Deviation|Mean
2778150|NCT00684021|Secondary|Clincal and Safety Outcomes|Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements|Measured from baseline to six months.|All randomized patients were followed for clinical outcomes.|||events|||Number
2778151|NCT00684021|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in Global EF from baseline to six months."|||percentage of ejection fraction||Standard Deviation|Mean
2778152|NCT00683930|Secondary|Duration of Prednisone Maintenance Dosing|The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.|||Days||Inter-Quartile Range|Median
2778153|NCT00683930|Secondary|Time to Sustained Response|Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.|||Weeks||Full Range|Median
2778154|NCT00683930|Secondary|Time to Initial Response|Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.|||Weeks||Inter-Quartile Range|Median
2778155|NCT00683930|Primary|Percentage of Patients Achieving Responder Status at Week 52|The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.|||Percentage of Participants|||Number
2778156|NCT00683917|Primary|The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.||4 months|Study prematurely terminated||||||
2778157|NCT00683904|Secondary|Total Body Clearance of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||Liters/hour||Standard Deviation|Mean
2778158|NCT00683904|Secondary|Volume of Distribution at Steady State of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||Liters||Standard Deviation|Mean
2778159|NCT00683904|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles|||ng*h/mL||Standard Deviation|Geometric Mean
2778162|NCT00683904|Secondary|Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment|Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.|Days 1 through 21 (Cycle 1)|All treated participants with measurable disease at baseline, as determined by investigator|||Participants|||Number
2778163|NCT00683904|Secondary|Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status|Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.|At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)||||Participants|||Number
2778164|NCT00683904|Secondary|Number of Participants With Abnormalities in Blood Pressure and Heart Rate|Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.|At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)||||Participants|||Number
2778165|NCT00683904|Secondary|Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade|Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.|At screening and Days 8 and 15 of Cycle 1 (21 days)||||Participants|||Number
2778166|NCT00683904|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade|ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
2778167|NCT00683904|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade|"LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365)~Appendix 7.1.2"|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
2778168|NCT00683904|Secondary|Number of Participants With Grade 3 or Greater Treatment-related AEs|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All subjects who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
2778169|NCT00683904|Secondary|Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation|An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
2778170|NCT00683904|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||mg/min/mL|||Number
2778171|NCT00683904|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin|||Participants|||Number
2778179|NCT00683852|Other Pre-specified|Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis compared AEs between the arms that received exclusively drug throughout the study or placebo throughout the study.|12 Weeks||||Patients|||Number
2778378|NCT00682786|Secondary|Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy|The data was not collected for this outcome measure as the questionnaire was encouraged but not required.||||||
2778172|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2|||kg||Standard Error|Mean
2778173|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing waist circumference values at baseline and Week 24 (LOCF)|||cm||Standard Error|Mean
2778174|NCT00683878|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||Percentage of participants||Standard Error|Mean
2778175|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2778176|NCT00683878|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
2778177|NCT00683878|Secondary|Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2778178|NCT00683878|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
2778220|NCT00683787|Secondary|Toxicity||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
2778180|NCT00683852|Other Pre-specified|Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. This analysis focused on placebo non-responders in phase 1 and presented them by their treatment assignment in phase 2.|12 Weeks|Of the 138 phase 1 placebo non-responders, 14 dropped out in phase 2: 9 in the drug arm and 5 in the placebo arm. Therefore, 124 total placebo non-responders from phase 1 were included in the analysis.|||Patients|||Number
2778181|NCT00683852|Other Pre-specified|Treatment Emergent AEs in Two Treatment Groups - Safety Sample|Differences in the incidence of treatment emergent AEs between the treatment groups were examined and evaluated using descriptive statistics. In this analysis, AEs were summarized according to person-phase of occurrence. Each AE was attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset.|12 Weeks|AEs were summarized according to person-phase of occurrence. Each AE will be attributed to the person and then to phase 1 or phase 2, depending on the initial date of onset. If the severity or other characteristic of the AE changes between phases, it can be counted in both phases. Also see Table 5 in Reference.|||adverse events|participant-phases||Number
2778182|NCT00683852|Secondary|Mean Change in Symptom Questionnaire (SQ)|The SQ, a 92-item (yes/no) self-rating questionnaire, includes 4 distress and 4 well-being subscales. There are 68 items for the distress subscales and 24 items for the well-being subscales. Each item has either a Yes/No or True/False answer. For the distress symptom score, add together the following items and score 1 when the answer is Yes/True: 1, 2, 3, 5, 6, 8, 11, 12, 15, 18, 20, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 36, 37, 39, 41, 42, 44, 45, 47, 48, 49, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 92. Minimum score is 0 and maximum score is 68. A higher score indicates more distress symptoms. For the well-being subscale score, add together the following items and score 1 when the answer is No/False: 4, 7, 9, 10, 13, 14, 16, 17, 19, 21, 23, 29, 31, 35, 38, 40, 43, 46, 50, 51, 71, 78, 83, 89. Minimum score is 0 and maximum score is 24. A higher score indicates more well-being.|Baseline and 12 weeks|This analysis used observed cases rather than LOCF (last observation carried forward), so some participants were missing follow-up data.|||units on a scale||Standard Deviation|Mean
2778183|NCT00683852|Secondary|Mean Change in Clinical Global Impression of Severity (CGI-S)|The CGI-S scale was administered by clinicians based on assessment of the patient's clinical status. They measured, based on history and scores on other instruments, depressive severity. It consists of one question scored on a seven-point scale (1 = normal to 7 = among the most severe), so a higher total score indicates greater depressive severity. The minimum score is 1, and the maximum score is 7.|Baseline and 12 weeks|This analysis used observed cases rather than LOCF (last observation carried forward), so some participants were missing follow-up data.|||units on a scale||Standard Deviation|Mean
2778184|NCT00683852|Secondary|Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up|The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|Baseline and 12 Weeks||||units on a scale||Standard Deviation|Mean
2778185|NCT00683852|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate|MADRS readmission rate is defined as MADRS score<11. The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|12 weeks||||Participants|||Count of Participants
2778186|NCT00683852|Primary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate|The primary outcome was the difference in response rate (decrease in MADRS total score of at least 50%) using the SPCD (sequential parallel comparison design). The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity over the past week, was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.|12 weeks||||Participants|||Count of Participants
2778187|NCT00683826|Primary|Weight||at the end of each study treatment arm (six weeks)|||||||
2778188|NCT00683826|Secondary|Energy Expenditure||will be measure at the end of each treatment period (6 weeks)|||||||
2778189|NCT00683826|Primary|Effects on Weight||4 weeks||||kilograms||Standard Deviation|Mean
2778190|NCT00683800|Other Pre-specified|Number of Participants With Hepatic Events|Hepatic events were defined as incidence of increased Liver Function Test (AST [aspartate aminotransferase] or ALT [alanine aminotransferase]) levels greater than 5 times the ULN (upper limit of normal).|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2778191|NCT00683800|Other Pre-specified|Number of Participants With Ischemic Heart Disease|"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) Ischemic Heart Disease."|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2778192|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA|"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for central nervous system haemorrhages and cerebrovascular conditions. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA."|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2778221|NCT00683787|Secondary|Overall Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
2778222|NCT00683787|Secondary|Progression-free Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
2778193|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke|"Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for central nervous system haemorrhages and cerebrovascular conditions. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA."|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2778194|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12|PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
2778195|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6|PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
2778196|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12|PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
2778197|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12|PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
2778198|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6|PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
2778199|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12|PGI-C score was intended to assess the study participant's perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
2778200|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
2778201|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
2778202|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.|||Percentage of Participants|||Number
2778223|NCT00683787|Primary|Overall Response Rate||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.||||||
2778224|NCT00683774|Primary|Level of Circulating D-chiro Inositol (DCI)|Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide|12 days||||nmol/mL||Full Range|Mean
2778203|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
2778204|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
2778205|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.|||Percentage of Participants|||Number
2778206|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.|||Units on a Scale||Standard Error|Mean
2778207|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.|||Units on a Scale||Standard Error|Mean
2778208|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy Greene Climacteric Scale (GCS) assessment or at least 1 on therapy Patient Global Impression (PGI) assessment.|||Units on a Scale||Standard Error|Mean
2778209|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12|Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Units on a Scale||Standard Error|Mean
2778210|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Hot Flushes||Standard Error|Mean
2778225|NCT00683774|Primary|Renal Clearance of D-chiroinositol (DCI) at 12 Days|Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay|12 days||||ml/min||Full Range|Mean
2778211|NCT00683800|Secondary|Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes|Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.|Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy.|||Days||95% Confidence Interval|Median
2778212|NCT00683800|Secondary|Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Percentage of participants|||Number
2778213|NCT00683800|Secondary|Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Percentage of participants|||Number
2778214|NCT00683800|Secondary|Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes|A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Participants|||Number
2778215|NCT00683800|Primary|Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events|Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2778216|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Mean
2778217|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 4|MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4.|||Units on a Scale||Standard Error|Mean
2778218|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.|||Hot Flushes||Standard Error|Mean
2778219|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 4|Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4.|||Hot Flushes||Standard Error|Mean
2778227|NCT00683696|Secondary|Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)|"Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.~This composite endpoint used a weighted scoring scale based on the African-American Heart Failure Trial (A-HeFT) study Endpoint Score. (Taylor, AL, Ziesche, S, Yancy, C, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. N Engl J Med 2004; 351:2049-57.)~Composite Endpoint Scoring:~Vital Status:~Death (-3),~Survival to end of trial (0),~Hospitalization:~1st hospitalization for HF (-1),~No hospitalization (0),~QOL score:*~Improvement by ≥ 10 units (+2),~Improvement by 5-9 units (+1),~Change by < 5 units (0),~Worsening by 5-9 units (-1),~Worsening by ≥ 10 (-2).~Possible total score -6 to +2.~*QOL score details are provided in Secondary Outcome Measure 5."|Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)|Subjects with a potential of 24 months of follow-up.|||Composite score||Standard Deviation|Mean
2778228|NCT00683696|Secondary|Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up|Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. Therefore, a negative change in QOL score from baseline to 6 months represents an improvement in quality of life, while a positive change in QOL score from baseline to 6 months represents a worsening in quality of life.|Changes between baseline and 6 months|Subjects with Baseline & 6-month QOL scores. 25 subjects (15 CRT ON, 10 CRT OFF) that were in the study at least 6 months and that did not have 6-month QOL data, had 3-month data inputted using the LOCF principle.|||units on a scale||Standard Deviation|Mean
2778229|NCT00683696|Secondary|New York Heart Association (NYHA) Classification Change|"Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.~NYHA classes:~Class I - Subjects with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea, or anginal pain.~Class II - Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III - Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV - Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|Subjects with Baseline & 6-month NYHA classification. 18 subjects (9 CRT ON, 9 CRT OFF) that were in the study at least 6 months and that did not have 6-month NYHA data, had the most recent post-randomization NYHA inputted using the Last Observation Carried Forward (LOCF) principle.|||Participants|||Count of Participants
2778230|NCT00683696|Secondary|Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)|Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).|Study duration from randomization to study exit||||Hospitalizations per subj-yr|||Number
2778231|NCT00683696|Primary|Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)|The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.|6 months|The primary safety endpoint included all subjects undergoing an implant procedure.|||participants|||Number
2778232|NCT00683696|Primary|Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death|The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.|From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years|This analysis was carried out according to the intention-to-treat principle. Follow-up was censored at study closure, date of death, LVAD, heart transplant, withdrawal from the study, or loss to follow-up, whichever came first. 4 deaths in CRT OFF group and 1 death in CRT ON group were after LVAD/transplant and are not included in this analysis.|||participants|||Number
2778233|NCT00683657|Secondary|Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4|Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
2778234|NCT00683657|Secondary|Change From Baseline in Mean Daily Glucose at Week 4|Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
2778235|NCT00683657|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4|Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
2778236|NCT00683657|Secondary|Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4|Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
2778237|NCT00683657|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.|||mg/dL||Standard Error|Mean
2778238|NCT00683644|Secondary|Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment|Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)|baseline and 4 months|Subjects that complete 4 months treatment|||units on a scale||Standard Deviation|Mean
2778239|NCT00683644|Secondary|Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment|Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception).|baseline and 4 months|Subjects that complete 4 months treatment|||units on a scale||Standard Deviation|Mean
2778240|NCT00683644|Primary|Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months|Validated questionnaire of tinnitus reactions. Scale 0 (no tinnitus reaction)- 100 (worst tinnitus reaction). Our primary outcome was the difference scores between Tinnitus Handicap Questionnaire (THQ) on baseline and end of treatment on zinc and placebo treatment. As stated by Newman et al., the test-retest variability was 20%, and difference scores greater than this should be considered a significant reduction. Therefore, changes on the difference scores of 20 or greater were considered as a statistically significant and therefore clinically meaningful improvement for THQ. The minimum score is zero and the maximum is 100. 0 is better and 100 is worse. This applies to all outcome measures.|baseline - 4 months|For data analysis purposes subjects were recombined in 2 groups (Zinc and Placebo). Group ZINC: subjects who completed 4 months with Zinc 50 mg daily either from baseline to month 4, or after washout (from month 5 to 9). Group PLACEBO: subjects who completed 4 months with placebo either from baseline to month 4, or after washout (from month 5 to 9)|||units on a scale||Standard Deviation|Mean
2778241|NCT00683618|Secondary|Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|from week 6 to week 12|Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator’s discretion.|||percentage of patients|||Number
2778242|NCT00683618|Secondary|6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL); non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL),non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percentage of patients|||Number
2778243|NCT00683618|Secondary|Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percentage of patients|||Number
2778244|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778245|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778246|NCT00683618|Secondary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778247|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778248|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778249|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778250|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778251|NCT00683618|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||Percent change||Standard Error|Least Squares Mean
2778252|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778253|NCT00683618|Secondary|Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.|||percent change||Standard Error|Least Squares Mean
2778254|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.|baseline, 6 weeks||||Percent change||Standard Error|Least Squares Mean
2778255|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.|baseline, 6 weeks||||percent change||Standard Error|Least Squares Mean
2778256|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8|MADRS remission was defined as a MADRS total score < 10 at Week 8. The remission rate is the percentage of subjects in each treatment group who met the criteria for remission. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Participants|||Number
2778257|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8|MADRS response was defined as ≥ 50% decrease from baseline in MADRS total score at Week 8. The response rate is the percentage of subjects in each treatment group meeting the criteria for response. The method of last observation carrier forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Participants|||Number
2778258|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score|The HAM-A is a rating scale developed to quantify the severity of anxiety. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Change from baseline in the HAM-A total score may range from -52 to 52 with negative value indicating improvement in anxiety symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2778259|NCT00683592|Secondary|The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8|The CGI-I scale measures change from the baseline state at every visit after the baseline visit. It permits a global evaluation of the patient's improvement over time. At the scheduled clinic visits, the clinician assessed the patient's improvement relative to the symptoms at baseline on a CGI-I item using a 7-point scale, where 1 = very much improved and 7 = very much worse. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2778260|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score|The HAM-D 17 is a 17-item subscale of the HAM-D 21, which is designed to be completed by a trained rater. It is designed for rating depressive symptom severity in patients with a confirmed diagnosis of depressive disorder. The change in HAM-D 17 has a possible range of -52 to 52 with negative values indicating improvment in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, week 1, week 2, week 4, week 6, week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2778261|NCT00683592|Primary|Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.|The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2778262|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 30|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.||||||
2778263|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 16|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.||||||
2778264|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 15|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.||||||
2778265|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 1|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.||||||
2778266|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 30|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.||||||
2778267|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 16|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.||||||
2778268|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 15|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.||||||
2778269|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 1|"Maximum Concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.||||||
2778270|NCT00683475|Secondary|Objective Response Rate (ORR)|"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100."|Baseline to date of progressive disease or death up to 36.3 months|Participants with measurable disease at baseline, who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2778271|NCT00683475|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive.|First dose to death due to any cause up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. Twelve participants were censored in the IMC-1121B + Mitoxantrone + Prednisone arm"|||months||95% Confidence Interval|Median
2778272|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 12-months|"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|12 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2778273|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 9-months|"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|9 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2778274|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 6-months|"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|6 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2778275|NCT00683475|Secondary|Prostate Specific Antigen (PSA) Response Rate|PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline.|Baseline up to data cut-off date (up to 36.3 months)|Participants who received any quantity of study drug, had baseline PSA value >= 2 ng/ml and at least one non-missing post-baseline PSA.|||percentage of participants||95% Confidence Interval|Number
2778276|NCT00683475|Secondary|Time to Radiographic Evidence of Disease Progression|"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy."|Randomization to date of radiographic progression, up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~34 participants were censored in IMC-A12 arm and 34 participants were censored in IMC-1121B (ramucirumab) arm."|||months||95% Confidence Interval|Median
2778277|NCT00683475|Secondary|Summary Listing of Participants Reporting Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Randomization to 36.3 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||participants|||Number
2778278|NCT00683475|Primary|Composite Progression-free Survival (cPFS)|"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|Randomization to composite progressive disease, up to 23.4 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~11 participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. 15 participants were censored in the IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone arm."|||months||95% Confidence Interval|Median
2778279|NCT00683449|Secondary|Hospital Admission Rate During Visit 1|After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.|Hour -1.5 through Hour 5||||participants|||Number
2778280|NCT00683449|Secondary|FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.|FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.|Baseline to Hour 2|29 subjects experiencing an acute exacerbation of asthma were at approximately 8 ED sites. The sample size was based on feasibility and precedent for this type of study, rather than statistical considerations.|||liters per second||Full Range|Mean
2778446|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778281|NCT00683449|Primary|Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo.|The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.|Baseline and Hour 2|The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the study.|||FEV1 (percent of predicted)||Full Range|Mean
2778282|NCT00683410|Primary|Number of Participants With Spontaneous Adverse Events||30 days post injection up to 3 years|Safety Analysis set - all participants who received at least one dose of Prevenar|||Participants|||Number
2778283|NCT00683384|Primary|Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection||30 days post injection up to 3 years|Full analysis set|||Participants|||Number
2778284|NCT00683332|Primary|Number of Participants With Spontaneous Adverse Events|"Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit?"|30 days post injection up to 3 years|Safety Population: All participants who received at least 1 dose of tygacil|||Participants|||Number
2778285|NCT00683293|Secondary|Complications||up to 2 weeks||||participants|||Number
2778286|NCT00683293|Primary|Duration of Surgery|•Mean Time to complete surgery from cut to suture|after surgey||||minutes||Standard Deviation|Mean
2778287|NCT00683163|Secondary|Change From Baseline in Trabecular Spine vBMD|Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.|Baseline, 24 months.||||Percent change from baseline||Standard Deviation|Mean
2778288|NCT00683163|Primary|P1NP (ng/ml) Change From Baseline.|After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.|Baseline, 3 months|Analyses were performed according to intention-to-treat principle. A sample size of 20 participants per group was estimated to provide 80% power to detect a change of 25ng/mL in PINP, assuming the SD of 40ng/mL observed previously with concurrent PTH(1-84) and daily alendronate.|||Percent change from baseline||95% Confidence Interval|Geometric Mean
2778289|NCT00683085|Secondary|Number of Participants With Tumor Regression|Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.|2 months|intension to treat (ITT)|||participants|||Number
2778290|NCT00683085|Primary|Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events|Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)|2 months|Intention to treat (ITT)|||participants|||Number
2778291|NCT00683046|Secondary|Median Overall Survival|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years||||Days||95% Confidence Interval|Median
2778292|NCT00683046|Primary|Median Disease-free Survival|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years||||Days||95% Confidence Interval|Median
2778293|NCT00683020|Secondary|Changes in Diastolic Blood Pressure (DBP)|Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||mm Hg||Standard Error|Least Squares Mean
2778294|NCT00683020|Secondary|Changes in Systolic Blood Pressure (SBP)|Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||mm Hg||Standard Error|Least Squares Mean
2778406|NCT00682539|Primary|Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome|12 month||||logMAR||Standard Deviation|Mean
2778295|NCT00683020|Secondary|Changes in Hemoglobin A1c Levels|Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 6-month level minus baseline level.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||percentage||Standard Error|Least Squares Mean
2778296|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale|The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on providers' communication over the prior 6 months. The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778297|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale|The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score. Higher transformed and total scale scores indicate better care. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778298|NCT00683020|Secondary|Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale|The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778299|NCT00683020|Secondary|Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778300|NCT00683020|Secondary|Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778301|NCT00683020|Secondary|Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities|"A measure of diabetes interference on patients is ascertained by asking patients the following question: In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others? Responses consist of 6 possible options: Always, Almost Always, Often, Sometimes, Almost Never, and Never. These responses are grouped into 2 categories, with one category consisting of Always, Almost Always, and Often responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined."|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||proportion of patients|||Number
2778302|NCT00683020|Secondary|Number of Days Spent in Bed Due to Illness|"A measure of patients' functional status is ascertained by asking patients the following question: In the last 30 days, how many days did health problems keep you in bed for all or most of the day? Number of days may range from 0 to 30, with lower number of days indicating better functional status. Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported. A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness). To calculate the mean, one raises e by the number given as the log mean. Lower log means indicate better functional status."|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||log days||95% Confidence Interval|Mean
2778303|NCT00683020|Primary|Changes in the Mental Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778304|NCT00683020|Primary|Changes in the Physical Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.|||units on a scale||Standard Error|Least Squares Mean
2778305|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score|The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Modified Social Support scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778306|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score|The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Modified Social Support scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778307|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score|The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 14 subjects completed all Mental Health Inventory questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure. The Mental Health Inventory was added late to the study beginning with subject 22 of 42|||units on a scale||Standard Deviation|Mean
2778308|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score|The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through Wk 7; 2 subjects who discontinued early (AE & withdraw by subject) were active at Wk 3 and were included in the Wk 3 analysis; 14 subjects completed all MHI questions at both the Wk 0 and Wk 3 and were analyzed for this outcome measure. The MHI was added late to the study beginning with subject 22 of 42|||units on a scale||Standard Deviation|Mean
2778309|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score|The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Perceived Deficits scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778310|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score|The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Perceived Deficits scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778311|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score|The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects completed all Impact of Visual Impairment scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778312|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score|The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Impact of Visual Impairment scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778313|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score|The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects completed all Bowel Control scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778380|NCT00682786|Primary|Rate of Tumor Downstaging Compared With Historical Controls.|"Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.~Historical studies demonstrate a DS rate of 45%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"|||percentage of participants||95% Confidence Interval|Number
2778314|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score|The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Bowel Control scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778315|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score|The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects completed all Bladder Control scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778316|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score|The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects completed all Bladder Control scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778317|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score|"The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered No to the question, Do you have a relationship with one primary partner, did not complete the scale. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 19 subjects completed all Sexual Satisfaction scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778318|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score|"The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered No to the question, Do you have a relationship with one primary partner, did not complete the scale. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 19 total subjects completed all Sexual Satisfaction scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778319|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score|The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects completed all Pain Effects scale questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778320|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score|The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects completed all Pain Effects scale questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778321|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score|The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0 - 84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects completed all Modified Fatigue Index questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778322|NCT00682929|Secondary|Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score|The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects completed all Modified Fatigue Index questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778323|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 23 subjects completed all SF-36 mental component questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778324|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 21 total subjects completed all SF-36 mental component questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778325|NCT00682929|Secondary|Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 23 subjects completed all SF-36 physical component questions at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778326|NCT00682929|Secondary|Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score|The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE & withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 21 total subjects completed all SF-36 physical component questions at both the Wk 0 and Wk 3 study visits and were analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778327|NCT00682929|Secondary|Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had completed & scored EDSS assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778328|NCT00682929|Secondary|Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had completed & scored EDSS assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778329|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Cerebral|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Cerebral assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778330|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Cerebral|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Cerebral assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778331|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Bowel & Bladder assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778332|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Bowel & Bladder assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778333|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Sensory|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Sensory assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778381|NCT00682734|Primary|Pain Intensity Score|Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.|Baseline, 60 minutes|per protocol|||scores on a scale||Standard Deviation|Mean
2778334|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Sensory|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Sensory assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778335|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Cerebellar|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Cerebellar assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778336|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Cerebellar|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had FS Cerebellar assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778337|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Pyramidal|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Pyramidal assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778338|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Pyramidal|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Pyramidal assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778339|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Brainstem|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Brainstem assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778405|NCT00682539|Primary|Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome|12 months||||µm||Standard Deviation|Mean
2778340|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Brainstem|The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had FS Brainstem assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778341|NCT00682929|Secondary|Change From Week 0 to Week 7 in Functional System Score - Vision|"The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).~Higher values indicate more impaired vision. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had FS Vision assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778342|NCT00682929|Secondary|Change From Week 0 to Week 3 in Functional System Score - Vision|"The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).~Higher values indicate more impaired vision. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had FS Vision assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778343|NCT00682929|Secondary|Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects had PASAT assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||number correct||Standard Deviation|Mean
2778344|NCT00682929|Secondary|Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 29 total subjects had PASAT assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||number correct||Standard Deviation|Mean
2778345|NCT00682929|Secondary|Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 25 subjects had 9 Hole Peg tests (non-dom. hand) performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
2778379|NCT00682786|Secondary|Complete Response Rates|"Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0).~Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0).~pCR rate of historical controls is 8%-14%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"|||percentage of participants|||Number
2778346|NCT00682929|Secondary|Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The non-dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects had 9 Hole peg tests (non-dom. hand) at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
2778347|NCT00682929|Secondary|Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had 9 Hole Peg tests (dominant hand) performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
2778348|NCT00682929|Secondary|Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time|"The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.~A negative result indicates an improvement in arm and hand function and correlates with a better outcome."|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 26 total subjects had 9 Hole Peg tests (dominant hand) at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
2778349|NCT00682929|Primary|LIDO Machine Score - Rate of Torque Increase, Extension|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had Lido assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
2778350|NCT00682929|Primary|Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had Lido assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
2778351|NCT00682929|Primary|Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; only 25 total subjects had Lido assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
2778352|NCT00682929|Secondary|Change From Week 0 to Week 7 in 25 Foot Walk Time|The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 26 subjects had 25 Foot Walk tests performed at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
2778353|NCT00682929|Secondary|Change From Week 0 to Week 3 in 25 Foot Walk Time|The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 22 total subjects had 25 Foot Walk tests performed at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||seconds||Standard Deviation|Mean
2778354|NCT00682929|Secondary|Change From Week 0 to Week 7 in Ambulation Index (AI) Score|The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, all 28 subjects had Ambulation Index assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778355|NCT00682929|Secondary|Change From Week 0 to Week 3 in Ambulation Index (AI) Score|The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 27 total subjects had Ambulation Index assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778356|NCT00682929|Secondary|Change From Week 0 to Week 7 in Modified Ashworth Score|The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.|Week 0, Week 7|Only 28 subjects completed the study through the Wk 7 visit; Of these 28 subjects, only 27 subjects had Ashworth assessments at both the Week 0 and Week 7 study visits and were able to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2778357|NCT00682929|Secondary|Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)|The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; 28 total subjects had Ashworth assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||units on scale||Standard Deviation|Mean
2778358|NCT00682929|Primary|Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion|A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.|Week 0, Week 3|Only 28 subjects completed the study through the Wk 7 visit; 2 subjects who discontinued early (AE and withdraw by subject) were active at the Wk 3 visit and were included in the Wk 3 analysis; only 25 total subjects had Lido assessments at both the Week 0 and Week 3 study visits and were able to be analyzed for this outcome measure.|||degrees/second||Standard Deviation|Mean
2778359|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).|baseline and 3 months||||min-1/(µlU/L)||Standard Deviation|Mean
2778426|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778360|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).|baseline and 3 months||||units on a scale||Standard Deviation|Mean
2778361|NCT00682851|Secondary|Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.|Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
2778362|NCT00682851|Secondary|Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.|Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
2778363|NCT00682851|Secondary|Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
2778364|NCT00682851|Primary|Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1||||Percentage of Participants||95% Confidence Interval|Number
2778365|NCT00682838|Primary|Nightly CPAP Adherence|Nightly CPAP adherence hours per night measured over the three-months period|3 mos||||hours per night||Standard Deviation|Mean
2778366|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
2778367|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
2778368|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
2778369|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
2778370|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
2778371|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
2778372|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.|||participants|||Number
2778373|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|"Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.~MTHFR gene = methylenetetrahydrofolate reductase (NAD(P)H)"|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.|||participants|||Number
2778374|NCT00682786|Post-Hoc|Relapse-free Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|"14 patients in the Good Risk arm had metastatic rectal cancer at time of enrollment are not included in this analyses.~3 patients in the Poor Risk arm had metastatic rectal disease before surgery and are included in this analyses.~2 of the patients in the Good Risk arm and Poork Risk arm withdrew consent and are not included."|||percentage of participants|||Number
2778375|NCT00682786|Post-Hoc|Overall Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.|||percentage of participants|||Number
2778382|NCT00682643|Secondary|Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods|rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).|Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2778383|NCT00682643|Secondary|Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104|"The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the cup portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology."|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||percent change||Standard Deviation|Mean
2778384|NCT00682643|Secondary|Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104|ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the [decadic] logarithm of the minimum angle of resolution [range from +1.00 to -0.30]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
2778385|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
2778386|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.|Baseline and Week 52|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
2778387|NCT00682643|Secondary|Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||mm Hg||Standard Deviation|Mean
2778388|NCT00682643|Secondary|Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104|Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
2778389|NCT00682643|Secondary|Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104|Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
2778390|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
2778391|NCT00682643|Secondary|Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
2778392|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104|An event for P is defined as an increase of >=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||participants|||Number
2778393|NCT00682643|Secondary|Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.|||scores on a scale||Standard Deviation|Mean
2778394|NCT00682643|Primary|Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event|An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants with post-baseline ophthalmic examination data were included in the analysis for this endpoint.|||percentage of participants|||Number
2778395|NCT00682643|Primary|Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.|||Percentage of participants|||Number
2778396|NCT00682617|Secondary|Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale|The WOMAC Physical Function Subscale has a range of 0-68, with higher scores indicating worse functional limitations. Calculated as change from baseline to 3 months.|3 months||||units on a scale||Inter-Quartile Range|Median
2778397|NCT00682617|Secondary|Change in Pain Visual Analog Scale|Evaluated using a 100mm pain VAS (range 0-100), with higher scores indicating worse pain. Calculated as change from baseline to 3 months.|3 months||||units on a scale||Inter-Quartile Range|Median
2778398|NCT00682617|Primary|Change in 6-minute Walk Test|Calculated as change from baseline to 3 months|3 months||||meters||Inter-Quartile Range|Median
2778399|NCT00682565|Secondary|Participants With 1 mm ST Segment Depression During ETT-3|ST Segment Depression measured by Electrocardiography while performing ETT-3.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3. However, majority of patients did not have ECGs assessable (per protocol) for 1 mm ST depression.|||Participants|||Number
2778400|NCT00682565|Secondary|Participants Stopping ETT-3 for Angina at Any Stage|"This Outcome Measure includes all participants who stopped ETT-3 for angina at any stage, not only those who stopped at a stage earlier than ETT-B.~Note: All 9 subjects who stopped ETT-3 for angina also stopped ETT-B for angina."|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||Participants|||Number
2778401|NCT00682565|Secondary|Increase in Exercise Duration During ETT-3 vs. ETT-B||1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||seconds||Standard Deviation|Mean
2778402|NCT00682565|Secondary|Participants Stopping ETT-3 for Any Reason at Stage Earlier Than ETT-B|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||Participants|||Number
2778403|NCT00682565|Primary|Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B)|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.|||Participants|||Number
2778404|NCT00682539|Secondary|To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.|Area of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.|12 month||2016-06-30|06/2016||||
2778427|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778407|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
2778408|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 12|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
2778409|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 6|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
2778410|NCT00682461|Secondary|Percentage of Participants With Adverse Events|"Adverse Event=any untoward medical occurrence in a subject following administration of an investigational product, which did not necessarily have a causal relationship with this treatment.~Serious Adverse Event=any untoward medical occurrence that at any dose; results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect"|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
2778411|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 1|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.|||Percentage|||Number
2778412|NCT00682435|Secondary|Change in Pain Intensity|Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable) from baseline to 60 minutes after medication infused|60 minutes after medication infused||||units on a scale||Inter-Quartile Range|Median
2778413|NCT00682435|Secondary|Number of Patients With Reduction in Pain Intensity|Pain intensity is measured on the numerical rating scale (NRS), with a pain score from 0 (no pain) to 10 (worst pain imaginable). The reduction in pain intensity is defined here as a change in pain score by 2 or more units.|60 minutes after medication infused||||% of participants|||Number
2778414|NCT00682435|Primary|Number of Patients With Oxygen Desaturation Less Than 95%|primary safety outcome, defined as number of participants who experienced oxygen saturation < 95%|120 minutes after medication infused|Total of 223 split into patients who received only 1 mg of IV hydromorphone (179) and those who received 2 mg of IV hydromorphone|||Participants|||Count of Participants
2778415|NCT00682435|Primary|Number of Patients Who Had Adequate Analgesia|Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol|60 minutes after medication infused|Those given a second dose only included patients who wanted more pain medication 15 minutes after 1st dose. 7 patients did not receive the second dose, resulting in 44 patients analyzed instead of expected 51|||Participants|||Count of Participants
2778416|NCT00682357|Secondary|Change in Serum Cortisol|Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.|Change from Baseline Visit to Day 28||||mcg/dL||Standard Deviation|Mean
2778417|NCT00682357|Secondary|Change in Testosterone|Outcome represents the mean change in testosterone level from baseline visit to day 28.|Change from Baseline Visit to Day 28|Only males randomized to Group 1 - Standard Dose were included in this analysis.|||ng/dL||Standard Deviation|Mean
2778418|NCT00682357|Primary|Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)|Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.|Change from Baseline Visit to Day 28||||U/L||Standard Deviation|Mean
2778419|NCT00682357|Primary|Change in Serum Osteocalcin|Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.|Change from Baseline Visit to Day 28||||ng/mL||Standard Deviation|Mean
2778420|NCT00681889|Secondary|Efficacy by Measuring Mean Change of BCVA||Prospective|||||||
2778421|NCT00681889|Secondary|Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs||Prospective|||||||
2778422|NCT00681889|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||16 Weeks|||||||
2778423|NCT00681889|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing|16 Weeks|All participants enrolled into the study were analyzed.|||participants|||Number
2778424|NCT00681863|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters|Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)|Baseline and 24 weeks|Observed Cases Treated set (OC TS). All participants in Treated Set having observed data at the particular timepoint.|||participants|||Number
2778425|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||participants|||Number
2778428|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778429|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778430|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778431|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778432|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778433|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778434|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||participants|||Number
2778435|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778436|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778437|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778438|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778439|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778440|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778441|NCT00681863|Primary|Patients With Adverse Events Leading to Discontinuation of Trial Drug|Number of patients with Adverse Events leading to discontinuation of trial drug|24 Weeks|Treated set|||participants|||Number
2778442|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778443|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.||||||
2778444|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness, Categorized|"Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).~Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement."|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||participants|||Number
2778445|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||score on a scale||Standard Deviation|Mean
2778505|NCT00681564|Secondary|Vascular Cell Adhesion Molecule 1 (VCAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
2778447|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778448|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778449|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778450|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778451|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778452|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778453|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778454|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778455|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778456|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778457|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778458|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778459|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778460|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778461|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778462|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778506|NCT00681564|Secondary|Intercellular Adhesion Molecule 1 (ICAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
2778463|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.|||Score on a scale||Standard Deviation|Mean
2778464|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24 (end of treatment visit)|The Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).|||Score on a scale||Standard Deviation|Mean
2778465|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||Score on a scale||Standard Deviation|Mean
2778466|NCT00681824|Secondary|Number of Participants With Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||participants|||Number
2778467|NCT00681824|Secondary|Incidence of Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||percentage of participants||95% Confidence Interval|Number
2778468|NCT00681824|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"|||participants|||Number
2778469|NCT00681824|Secondary|Number of Participants With Procedures Resulting From the Treatment of CSF Leaks|The number of participants with surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures.|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||participants|||Number
2778470|NCT00681824|Secondary|Incidence of Procedures Resulting From the Treatment of CSF Leaks|The incidence of surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"|||percentage of participants||95% Confidence Interval|Number
2778471|NCT00681824|Primary|Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"|||percentage of participants||95% Confidence Interval|Number
2778472|NCT00681811|Primary|Days of Exposure to HGT-1111|End of study was defined as until HGT-1111 was commercially available, the participant's participation was discontinued, or the study was terminated by the Sponsor.|Baseline until end of study (Week 139)|Safety population was defined as all enrolled participants who received at least one study infusion (or any portion of a dose) of HGT-1111.|||Days||Standard Deviation|Mean
2778473|NCT00681811|Secondary|Score of Gross Motor Function Measurement (GMFM)|Gross motor function was measured using GMFM-88 at 6-month intervals. The GMFM-88 item scores were summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) to 264 (maximum). Decrease in GMFM score indicates disease progression.|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."|||scores on a scale||Standard Deviation|Mean
2778474|NCT00681811|Secondary|Level of White Matter Metabolites|Level of white matter metabolites [N-acetyl Aspartate (NAA)] measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure. No participants were analysed after Month 18, hence, data were not available after Month 18."|||nmol/L||Standard Deviation|Mean
2778475|NCT00681811|Secondary|Level of Cerebrospinal Fluid (CSF) Sulfatide|Level of CSF sulfatide measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."|||nanomole per liter (nmol/L)||Standard Deviation|Mean
2778476|NCT00681668|Secondary|Electrocardiogram (ECG), Vital Signs, Laboratory|"Safety parameter:s electrocardiogram (ECG), vital signs, laboratory~no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated|||participants|||Number
2778477|NCT00681668|Secondary|Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)|Change in functional outcome: Global Assessment of Functioning (GAF),scale of 1-100 (1 = severe symptoms - 100 = no symptoms) Parental bonding Questionnaire (PBQ) no participants analysed - terminated study|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated|||scores on a scale||Full Range|Median
2778478|NCT00681668|Secondary|Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)|"Change in efficacy scales: Clinical Global Impression (CGI),Scale of 1-7 (1 = normal or no change - 7 = extremely ill or extreme changes).~Montgomery Asberg Depression Rating scale (MADRS) 10 questions with a scale of 1-4 (1 = no symptoms - 4 = severe symptoms), higher score = worst values.~Brief Psychiatric rating scale (BPRS)- 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe' no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated|||Units on a scale||Full Range|Mean
2778479|NCT00681668|Primary|The Change in the Hamilton Rating Scale for Depression (HAM-D)|HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state|Baseline Day 1 to final visit 28 weeks||||scores on a HAM-D scale||Full Range|Mean
2778480|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events|Listing of all adverse event or SAE´s to show the safety and tolerability.|4 month|No data were reported as no participants completed the study|||number of events|||Number
2778481|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Concomitant Medication|Listing of all concomitant medication to show the efficacy and safety.|4 month|No data were reported as no participants completed the study|||Name of concomitant medication|||Number
2778482|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Laboratory Tests|Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.|4 month|No data were reported as no participants completed the study|||depending on the Lab test (see above)||Full Range|Mean
2778483|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference|Measuring of weight and waist circumference in centimeter.|4 month|No data were reported as no participants completed the study|||centimeters||Standard Deviation|Mean
2778484|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication|Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.|4 month|No data were reported as no participants completed the study|||Drugs||Standard Deviation|Mean
2778485|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities|The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.|4 month|No data were reported as no participants completed the study|||days||Standard Deviation|Mean
2778486|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization|Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.|4 month|No data were reported as no participants completed the study|||days||Standard Deviation|Mean
2778487|NCT00681629|Secondary|Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)|"The 'CSQ-8 is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778488|NCT00681629|Secondary|Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)|The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.|4 month|No data were reported as no participants completed the study|||Participants|||Number
2778544|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Interfered With Daily Activities|The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded|||Participants|||Number
2778489|NCT00681629|Secondary|Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)|"The 'SES is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778490|NCT00681629|Secondary|Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale|"The '(RSM is a new 36-item measure validated to assess the QoL in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher QoL."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778491|NCT00681629|Secondary|Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire|Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778492|NCT00681629|Secondary|"Vocational Occupational Index VOC Score"|"The VOC index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment"|Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778493|NCT00681629|Secondary|EQ-5D (European Quality of Life Questionnaire) Score|"The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).~The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of severity- no problems, some problems and extreme problems. Higher scores indicate more problems."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778494|NCT00681629|Secondary|PSP (Personal and Social Performance) Scale Score|"The '(PSP rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778495|NCT00681629|Secondary|GAF (Global Assessment of Functioning) Scale Score|"The GAF is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778496|NCT00681629|Secondary|Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score|The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778497|NCT00681629|Secondary|Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale|With the CGI-S the rate of the severity of a patient's symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778498|NCT00681629|Secondary|Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 month|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778499|NCT00681629|Primary|Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 months|No data were reported as no participants completed the study|||Scores on a scale||Standard Deviation|Mean
2778500|NCT00681590|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D Levels||baseline and 6 months||||ng/ml||Standard Deviation|Mean
2778501|NCT00681590|Primary|Number of Participants Who Develop Hypercalcemia|calcium serum levels measured at baseline and at the end of the intervention (6-months)|6 months||||participants|||Number
2778502|NCT00681564|Secondary|Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
2778503|NCT00681564|Secondary|Matrix Metalloproteinase-9 (MMP-9)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
2778504|NCT00681564|Secondary|Myeloperoxidase (MPO)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
2778507|NCT00681564|Secondary|Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)|"Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®).~Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis."|12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.|||ng/ml||Standard Deviation|Mean
2778508|NCT00681564|Secondary|LDL Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||mg/dL||Standard Deviation|Mean
2778509|NCT00681564|Secondary|Subgingival Microbiota|Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).|12 weeks post-periodontal therapy||||participants|||Number
2778510|NCT00681564|Secondary|White Blood Cell Count||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||cells/mm^3||Standard Deviation|Mean
2778511|NCT00681564|Secondary|Total Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||mg/dL||Standard Deviation|Mean
2778512|NCT00681564|Secondary|High-sensitivity C-Reactive Protein|The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy||||mg/L||Standard Deviation|Mean
2778513|NCT00681564|Primary|Brachial Artery Flow-mediated Dilation|All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.|||Percentage of dilatation of brachial art||Standard Deviation|Mean
2778514|NCT00681538|Secondary|Mood Assessment: Change in Beck Depression Inventory - II (BDI-II)From Baseline to End of Treatment (Phase B)|This was a 21-question multiple choice self-report inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. An decrease in score indicates an improvement in condition.|Baseline (End of week 4) - end of treatment (end of week 17)||||Score on scale||Standard Deviation|Mean
2778515|NCT00681538|Secondary|Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B)|"The EQ-5D questionnaire provided two outcomes:~A weighted health state index visual analogue scale (VAS)~A self-rated health status VAS EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.~The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing."|[Baseline (End of Week 4) - End of treatment (End of Week 17)|EQ-5D Health State Index Sativex n=117 and placebo n=111. EQ-5D Health Status VAS Sativex n=121 and placebo n=117.|||score on scale||Standard Deviation|Mean
2778516|NCT00681538|Secondary|Physician Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)||||participants|||Number
2778517|NCT00681538|Secondary|Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.|||participants|||Number
2778518|NCT00681538|Secondary|Carer Global Impressions of Change at of Treatment (Phase B).||End of treatment (Week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.|||participants|||Number
2778519|NCT00681538|Secondary|Subject Global Impressions of Change at End of Treatment (Phase B).||End of Treatment (WeeK 17)||||participants|||Number
2778520|NCT00681538|Secondary|Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B).|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Baseline (End of Week 4) - End of treatment (End of Week 17)|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk.|||Seconds||Standard Deviation|Mean
2778521|NCT00681538|Secondary|Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)|For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo.|||Score on scale||Standard Deviation|Mean
2778522|NCT00681538|Secondary|Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)||||Score on scale||Standard Deviation|Mean
2778523|NCT00681538|Secondary|Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).|"The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked On a scale of '0 to 10' please indicate how you your spasticity disrupted your sleep last night with the anchors: 0 = 'did not disrupt sleep' and 10 = 'completely disrupted (unable to sleep at all)'."|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)||||Points on scale||Standard Deviation|Mean
2778524|NCT00681538|Secondary|Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).|The subjects' baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B).|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)||||Spasms per day||Standard Deviation|Mean
2778525|NCT00681538|Secondary|Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.|A subject was classified as a responder in the evaluable period provided they did not withdraw due to lack of efficacy and achieved at least a 30% or 50% reduction (i.e. improvement) in the mean NRS spasticity score from baseline (Day 1) to the end of treatment(last 7 days of Week 17 Phase B). All other subjects and subjects without evaluable data were considered non-responders.|Baseline (Day 1) - End of treatment (last 7 days of Week 17)||||participants|||Number
2778526|NCT00681538|Primary|The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).|"Subjects were asked On a scale of '0 to 10' please indicate the average level of your spasticity over the last 24 hours with the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'. They were asked to relate 'no spasticity' to the time prior to the onset of their spasticity."|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)||||Points on scale||Standard Deviation|Mean
2778527|NCT00681473|Secondary|Percentage of Participants With Overall Survival|Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years||||% of participants|||Number
2778528|NCT00681473|Secondary|Percentage of Participants With Progression Free Survival|Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years||||% of participants|||Number
2778529|NCT00681473|Primary|Number of Participants With Late Effects > 3 Months Post RT||5 years||||Participants|||Count of Participants
2778530|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 24 Months|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline."|Baseline to 24 Months|Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.|||units on a scale||Standard Deviation|Mean
2778531|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 12 Months|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline."|Baseline to 12 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.|||units on a scale||Standard Deviation|Mean
2778532|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 6 Months|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline."|Baseline to 6 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.|||units on a scale||Standard Deviation|Mean
2778545|NCT00681187|Primary|Subject Preference for Self or Partner Administration|A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection|Between week 30 to 34|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded|||participants|||Number
2778574|NCT00680914|Secondary|Anti-PD Antibody Concentration|Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.|One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2778533|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 3 Months|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty = 1 to Not able to do it = 5. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline."|Baseline to 3 Months|Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.|||units on a scale||Standard Deviation|Mean
2778534|NCT00681265|Secondary|Fluorescein Tear Film Break-up Time|Standard clinical assessment methodology for assessing tear stability.|120 minutes after eye drops instillation|Study N determined empirically by PI.|||seconds||Standard Deviation|Mean
2778535|NCT00681265|Primary|Noninvasive Tear Film Break-up Time|State-of-the-art methodology to assess tear stability.|15 minutes after eye drop instillation|Study N determined empirically by PI.|||seconds||Standard Deviation|Mean
2778536|NCT00681187|Secondary|Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method|"Assessed by the number of HCP with a positive response 'yes' to two questions:~Based on your experience during this trial, did you feel confident in the safety of your patients?~Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?"|Between week 30 to 34|One HCP from each site who enrolled participants replied to the question|||participants|||Number
2778537|NCT00681187|Secondary|5-hydroxyindoleacetic Acid (5-HIAA) Levels|"Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.~'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.~'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.~'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.~'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|5-HIAA were assessed as judged necessary by the investigator at each site.|||nmol/l||Standard Deviation|Mean
2778538|NCT00681187|Secondary|Chromogranin A Levels|"Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.~'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.~'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.~'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.~'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|ITT population that had hormone levels assessed at each administration block.|||nmol/l||Standard Deviation|Mean
2778539|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea|Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.|||participants|||Number
2778540|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Flushing|Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.|||participants|||Number
2778541|NCT00681187|Secondary|Total Number of Visits to HCP Due to Carcinoid Symptoms|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication|||visits|||Number
2778542|NCT00681187|Secondary|Days Sick Leave|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.|||days|||Number
2778543|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing|The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded|||participants|||Number
2778546|NCT00681109|Primary|Ocular Surface Disease Index (OSDI)|"The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4].~Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning.~OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12."|Baseline and 12 Week Time Point data|The OSDI analysis for this study is based on a standard intention-to-treat analysis with each study participant analyzed with respect to the randomized treatment assignment, regardless of eventual compliance.|||units on a scale||Standard Deviation|Mean
2778547|NCT00681109|Primary|Corneal Fluorescein Staining Score|Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|12 Week Time Point||||Units on a scale||Standard Deviation|Mean
2778548|NCT00681109|Primary|Tear Breakup Time (TBUT)|TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.|12 Week Time Point||||Seconds||Standard Deviation|Mean
2778549|NCT00681109|Primary|Meibomian Gland Secretion Quality|Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)|12 Week Time Point||||Units on a scale||Standard Deviation|Mean
2778550|NCT00681083|Secondary|Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time|A correlation table was computed to explore the relationship between the intervention (heated breathing tube vs no heated breathing tube) and total sleep time. This relationship was calculated for each arm and reported by a Correlation Coefficient (r score). The r score represents the strength and direction of a relationship between two variables. The value of r is always between -1 and +1. Therefore, an r score of -1 indicates a perfect negative relationship between the intervention and total sleep time. An r score of -.50 indicates a moderate negative relationship between the intervention and total sleep time. An r score of 0 indicates no relationship between the intervention and total sleep time. An r score of +.50 indicates a moderate positive relationship between the intervention and total sleep time. An r score of +1 indicates a perfect positive relationship between the intervention and total sleep time.|End of titration night||||r score|||Number
2778551|NCT00681083|Primary|Titration Pressures After Treatment Nights|Each night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure.|End of titration night||||cmH20||Standard Deviation|Mean
2778552|NCT00681044|Secondary|Tolerability||100 days|No data were collected or analyzed due to study termination||||||
2778553|NCT00681044|Secondary|Overall Survival||life|No data were collected or analyzed due to study termination||||||
2778554|NCT00681044|Secondary|Organ or Clinical Response||One year|No data were collected or analyzed due to study termination||||||
2778555|NCT00681044|Secondary|Predictability of Early Free Light-chain Response for Heme Response||One month|No data were collected or analyzed due to study termination||||||
2778556|NCT00681044|Primary|Hematologic Response Rate||one year|No data were collected or analyzed due to study termination||||||
2778557|NCT00681031|Primary|Geometric Mean Titre (GMT) of Varicella Antibodies|Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Predose (Day 0) and Day 28-35 Post Dose|All vaccinated participants excluding those with any protocol deviation which may have interfered with the immunogenicity evaluation and excluding participants with herpes zoster onset before the post-vaccination blood sample|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2778558|NCT00680992|Secondary|Mean Serum Denosumab Trough Concentrations|Blood samples for determination of serum denosumab concentration levels were obtained from participants included in the pharmacokinetic (PK) substudy at baseline (prior to administration of study drug on day 1) and at scheduled time points during the study up to week 25.|Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25.|The PK analysis set included all participants who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement. Only participants with available data at each time point were included in the analysis.|||nanograms / milliliter||Standard Deviation|Mean
2778559|NCT00680992|Secondary|Percentage of Participants Without Any On-Study Surgery at Month 6 for Cohort 2|The percentage of participants without any surgery at month 6 was equivalent to the number of participants without any surgery by month 6 divided by the number of cohort 2 participants who had an opportunity to complete 6 months of treatment, expressed as a percentage.|At month 6.|The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 2 only for those who had the opportunity to be on-study for at least 6 months.|||Percentage of participants||95% Confidence Interval|Number
2778572|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes|The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2778560|NCT00680992|Secondary|Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability|Time to disease progression or recurrence during the on-study period was defined as the time interval (in days) from the date of first dose of study drug to the date of earliest Progressive Disease (PD) during the initial treatment phase. PD was defined as the response of progressive disease, locally recurrent disease or relapse as captured in the Disease Status page of the Case Report Form. If a participant had not had PD by the end of the initial treatment phase date, time to disease progression or recurrence were censored at her/his end of initial treatment phase date. Since median time to disease progression or recurrence for participants in cohort 1 was not reached, Kaplan-Meier estimates for the probability (expressed as a percentage) of participants in cohort 1 to have disease progression or recurrence at months 6, 12, 24, 36 and 60 are presented.|From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).|The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 1 only.|||Percent probability||95% Confidence Interval|Number
2778561|NCT00680992|Primary|Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters|Serum samples for clinical chemistry were collected on study day 1 (baseline), day 15, week 5 and each study visit Q4W thereafter until last study visit for the on-study period (ie, until end of initial treatment phase). The parameters included albumin, calcium (albumin-adjusted), creatinine, magnesium and phosphate. Results are presented for number of participants who experienced the maximum toxicity grade for each of these clinical parameters. The maximum toxicity grade experienced by each participant was based on CTCAE, v3.0, and are summarized for Grade 3 and 4. Increases and decreases in relationship to the normal parameter ranges are indicated as 'Above' and 'Below' respectively.|Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).|The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.|||Participants|||Number
2778562|NCT00680992|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. Investigator assessed AEs for relatedness to study drug. Results are presented for treatment-emergent events (TEAEs) and included all AEs occurring from first dose in initial treatment phase to end of initial treatment phase (or for participants entering retreatment, from first dose in initial treatment phase until end of retreatment phase).|From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).|The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.|||Participants|||Number
2778563|NCT00680953|Secondary|Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.|The results are expressed as a percentage by Kaplan-Meier estimate.|Baseline to 24 Months||||percentage of participants|||Number
2778564|NCT00680953|Secondary|The Percentage of Non-vertebral Fractures|The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures|Baseline to 24 Months||||percentage of participants||95% Confidence Interval|Number
2778565|NCT00680953|Primary|Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo||Baseline to 24 months||||Vertebral fractures||95% Confidence Interval|Mean
2778566|NCT00680914|Secondary|Number of Subjects With Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
2778567|NCT00680914|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||Within 31 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
2778568|NCT00680914|Secondary|Number of Subjects With Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.~Fever was defined as axillary temperature >= 37.5 degrees Celsius."|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
2778569|NCT00680914|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||subjects|||Number
2778570|NCT00680914|Secondary|Number of Subjects With Seroprotection Status Against PRP|Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2778571|NCT00680914|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentration of anti-PRP antibody given as GMC in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||ug/mL||95% Confidence Interval|Geometric Mean
2778573|NCT00680914|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||ug/mL||95% Confidence Interval|Geometric Mean
2778575|NCT00680914|Secondary|Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine|Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||ug/mL||95% Confidence Interval|Geometric Mean
2778576|NCT00680914|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).~Pneumococcal cross-reactive serotypes were 6A and 19A."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2778577|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value|"The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8.~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2778578|NCT00680914|Secondary|Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes|"Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.~Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2778579|NCT00680914|Primary|Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after administration of 3rd dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2778580|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count.|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2778581|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]).|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
2778582|NCT00680901|Secondary|Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36|The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant's current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2778583|NCT00680901|Secondary|Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36|The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2778584|NCT00680901|Secondary|Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36|"The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from poor to excellent. All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms."|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2778585|NCT00680901|Secondary|Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population|||Participants|||Number
2778586|NCT00680901|Secondary|Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population: all randomized participants who received at least one dose of study medication|||Participants|||Number
2778587|NCT00680901|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause (average of 36 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
2778588|NCT00680901|Secondary|Time to Response (TTR)|TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator.|From Baseline (Day 1) until the first documented evidence of confirmed CR or PR (average of 9 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
2778589|NCT00680901|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator.|From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)|Primary Efficacy Population|||Participants|||Number
2778590|NCT00680901|Secondary|Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations).|From randomization until the date of the first documented response of CR or PR (average of 9 weeks)|Primary Efficacy Population|||Participants|||Number
2778608|NCT00680745|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.|At Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2778738|NCT00679627|Secondary|Change From Baseline in Institutional Status|This table describes the number of participants who were reported as institutionalized at baseline and Month 24.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.|||Number of Participants|||Number
2778591|NCT00680901|Secondary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks)|Primary Efficacy Population|||months||95% Confidence Interval|Median
2778592|NCT00680901|Primary|Overall Survival in All Randomized Participants|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment, regardless of whether they actually received study medication.|||months||95% Confidence Interval|Median
2778593|NCT00680901|Primary|Overall Survival|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Primary Efficacy Population: all randomized participants with Human Epidermal Growth Factor Receptor 2 (ErbB2)-positive tumors (based on Fluorescence In Situ Hybridization [FISH]-positive designated central laboratory assessment).|||months||95% Confidence Interval|Median
2778594|NCT00680862|Primary|Number of Participants Who Completed the Survey|survey responses from participants on thoughts pertaining to implementation of HIV rapid testing|6 months||||participants|||Number
2778595|NCT00680836|Secondary|Change in Bloating|Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.|2 weeks||||units on a scale||95% Confidence Interval|Mean
2778596|NCT00680836|Secondary|Change in Abdominal Pain With Bowel Movement|Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.|2 weeks||||units on a scale||95% Confidence Interval|Mean
2778597|NCT00680836|Secondary|Change in Bowel Urgency|Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.|2 weeks||||difference in percentage of 'Yes'||95% Confidence Interval|Mean
2778598|NCT00680836|Secondary|Change in Stool Consistency|Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.|2 weeks||||units on a scale (BSS)||95% Confidence Interval|Mean
2778599|NCT00680836|Secondary|Change in Stool Frequency (Number of Bowel Movements Per Day)|Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.|2 weeks||||Bowel movements/ day||95% Confidence Interval|Mean
2778600|NCT00680836|Primary|Global Improvement Scale|Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.|Measured for seven days at the end of 2 weeks treatment and average score is calculated||||units on a scale||Standard Deviation|Mean
2778601|NCT00680823|Secondary|Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study||72 hours||||Participants|||Count of Participants
2778602|NCT00680823|Secondary|Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision||3 hours||||Participants|||Count of Participants
2778603|NCT00680823|Primary|The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.||30 minutes||||Participants|||Count of Participants
2778604|NCT00680797|Primary|Insulin Sensitivity|As measured by change in insulin levels pre- and post-hormone changes|6 weeks|Two participants had missing values post-intervention therefore number of participants analyzed total 31.|||micro International Units/mL||Standard Deviation|Mean
2778605|NCT00680771|Primary|Positive Antibody Response|Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.|3 Months after initial vaccination|From subjects with complete data only.|||participants|||Number
2778606|NCT00680745|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2778607|NCT00680745|Secondary|Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2|To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with baseline BMI of 27 kg/m2 or more and Week 24 (LOCF) body weight value|||kg||95% Confidence Interval|Least Squares Mean
2778910|NCT00678379|Secondary|Total Time Until Discharge From Hospital.||Day of Surgery||||minutes||Full Range|Median
2778911|NCT00678379|Secondary|Median Number of Pain Medication Doses|The median number of intravenous fentanyl doses administered in the PACU due to pain|in recovery room|per group doses|||number of doses||Full Range|Median
2778609|NCT00680745|Secondary|Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise|To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2778610|NCT00680745|Secondary|Adjusted Mean Change in Body Weight|To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2778611|NCT00680745|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
2778612|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|8-Hour||||mm||95% Confidence Interval|Mean
2778613|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|Baseline||||mm||95% Confidence Interval|Mean
2778614|NCT00680628|Primary|Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome||90 days||||participants|||Number
2778615|NCT00680628|Primary|Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36)||90 days||||participants|||Number
2778616|NCT00680628|Primary|Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage||1,2,3,4, and 5 days||||participants|||Number
2778617|NCT00680524|Primary|Acceptability to Providers and Patients|Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below|Six months||||units on a scale||Standard Deviation|Mean
2778618|NCT00680459|Secondary|Recurrence of Central Venous Line Infection Within 35 Days of Enrollment||35 days||||# of pts with recurrent infection|||Number
2778619|NCT00680459|Secondary|Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study||35 days||||number of lines preserved|||Number
2778620|NCT00680459|Primary|Clearance of Central Venous Line Infection by Day 6 of Study||6 days||||number of CVL cleared|||Number
2778621|NCT00680407|Post-Hoc|Efficacy - Improvement by at Least 2 Points in Histology (NAS) - With NAS Without Cirrhosis|This outcome measure excludes the substantial percentage (62.8%) of patients with baseline biopsies that were deemed ineligible (per inclusion criteria) by the central pathologist due to NAS <4 or absence of NASH (nonalcoholic steatohepatitis) (n=34), NASH with presence of cirrhosis (n=1), or slides unavailable/not evaluable for reading (n=14).|48-50 week treatment period|Subgroup of ITT (Intent to Treat) Patients with NASH and without cirrhosis population|||participants|||Number
2778622|NCT00680407|Secondary|Safety - Occurrence of a Dose-limiting Toxicity||48-50 week treatment period||||participants|||Number
2778623|NCT00680407|Primary|Efficacy - Improvement by at Least 2 Points in Histology (NAS)|Histological Scoring System for Nonalcoholic Fatty Liver Disease ranges from 0-8 with the increase in number representing a worse outcome. Therefore the efficacy improvement was to be at least 2 points in lowering the score.|48-50 week treatment period||||participants|||Number
2778624|NCT00680368|Secondary|Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians|Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.|24 hours||||Intraclass Correlation Coefficient||95% Confidence Interval|Number
2778625|NCT00680368|Secondary|Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians|Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.|24 hours||||Intraclass Correlation Coefficient||95% Confidence Interval|Number
2778626|NCT00680368|Primary|Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.|Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.|24-hours||||Intraclass Correlation Coefficient||95% Confidence Interval|Number
2778627|NCT00680316|Secondary|Change in Respiratory Symptom Domain Score From the Cystic Fibrosis Questionnaire Revised (CFQ-R) for Parents of Preschoolers and for Preschoolers|"The CFQ-R for Preschoolers and the CFQ-R for Parents of Preschoolers was designed specifically to measure the impact of CF for patients with a diagnosis of CF. Each question is answered using a 4-point Likert scale.~In order to calculate the domain/symptom scale scores, the following algorithm is followed~Re-number items which have been reverse coded~Calculate the mean of the items to be included. If more than half of the items are missing, then the score is considered missing~Re-scale to result in a scaled score which ranges from 0 to 100, with higher scores indicating better health"|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
2778640|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic DVT|Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
2778628|NCT00680316|Secondary|Change in Resistance at 4, 6, 8, and 10 Hz (Rrs4, Rrs6, Rrs8, and Rrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Resistance is complex measure that incorporates the lack of changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (10Hz was used for the secondary endpoint).|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
2778629|NCT00680316|Secondary|Change in Reactance at 4, 6, and 10 Hz (Xrs4, Xrs6, and Xrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
2778630|NCT00680316|Primary|Change in Reactance at 8 Hz (Xrs8) From Visit 2 to Visit 3 (Change From Baseline at Visit 2 to Visit 3, After Study Drug Treatment).|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.||||||
2778631|NCT00680225|Secondary|Visual Acuity Changes||12 mo|PI has left the institution and summary data are not available.||||||
2778632|NCT00680225|Primary|Mean Tumor Thickness||12 mo||||mm||Full Range|Mean
2778633|NCT00680186|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout|TS|||participants|||Number
2778634|NCT00680186|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.|From first intake of study drug to last contact date|TS|||participants|||Number
2778635|NCT00680186|Secondary|Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events|"Major bleeding events (MBE) are defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) are defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
2778636|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE|Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
2778637|NCT00680186|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
2778638|NCT00680186|Secondary|Number of Participants Who Died Due to VTE|VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.|From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)|FAS|||participants|||Number
2778639|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
2779448|NCT00673881|Secondary|Change in Bile Acid Excretion|Change in bile acid excretion from baseline to end-of-treatment|Baseline to 12 weeks|||||||
2778641|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS|||participants|||Number
2778642|NCT00680186|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
2778643|NCT00680121|Secondary|Symptom Checklist-90 (SCL-90): Global Severity Index|The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population.|6 Months||||t-score||Standard Deviation|Mean
2778644|NCT00680121|Secondary|Barrett Impulsivity Scale: Total Impulsiveness|Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness.|6 Months||||scores on a scale||Standard Deviation|Mean
2778645|NCT00680121|Secondary|Alcoholism Severity Scale|The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence.|6 Months||||scores on a scale||Standard Deviation|Mean
2778646|NCT00680121|Primary|Change in Average Daily Alcohol Consumption|measured as standard drinks of alcohol per day (SD/day)|Change from Baseline to 6 Months||||alcoholic drinks per day||Standard Deviation|Mean
2778647|NCT00680056|Secondary|Mean Score on the Transitional Dyspnea Index (TDI)|TDI is a multidimensional clinical instrument developed to provide a comprehensive assessment of change in dyspnea after an intervention, considering three components (functional impairment, magnitude of task, and magnitude of effort). It ranges from -9 (major deterioration) to +9 (major improvement).|After 2 week of each treatment||||score on scale||Standard Deviation|Mean
2778648|NCT00680056|Primary|Percentage Change in Exercise Tolerance From Baseline at 2 Weeks|Percentage change from baseline in time to the limit of tolerance on a high intensity constant-speed treadmill exercise test (with a speed corresponding to 80% of that obtained during incremental test)|Baseline and after 2 weeks with each treatment|The specific period where the patient received a given treatment were analysed together.|||Percentage change||Standard Error|Mean
2778649|NCT00680043|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.|Weeks 1 to 28|Full Analysis Population|||percentage of participants|||Number
2778650|NCT00680043|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods||Weeks 1 to 28|Full Analysis Population|||percentage of participants|||Number
2778651|NCT00680043|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.|Baseline and Weeks 21-28|Full Analysis Population|||g/dL||Standard Deviation|Mean
2778652|NCT00680017|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.|High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Least Squares Mean
2778653|NCT00680017|Primary|Median Percent Change in Triglycerides From Baseline to Week 8.|Triglycerides were measured in milligrams/deciliter.|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Inter-Quartile Range|Median
2778654|NCT00679952|Secondary|Severity of Pancreatic Fistulas||2 years|||||||
2778655|NCT00679952|Primary|Number of Patients With Pancreatic Fistula|"pancreatic fistula rate is stratified according to ISGPF criteria.~Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate"|postoperative 1 week||||participants|||Number
2778656|NCT00679939|Post-Hoc|Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||millimoles per Liter (mmol/L)||Standard Error|Mean
2778657|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||millimoles per Liter (mmol/L)||Standard Error|Mean
2778658|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778659|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778660|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778661|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778662|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778663|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778664|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778665|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778666|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778890|NCT00678418|Secondary|Days to Discontinuation During Part A|Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.|168 days (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).|||Days to study discontinuation||95% Confidence Interval|Median
2778667|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778668|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778669|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778670|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778671|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778672|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778673|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778674|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778675|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778676|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778912|NCT00678379|Primary|Total Number of Post-operative Doses of Analgesics.|The total number of intravenous fentanyl doses given PACU which will be compared between the three randomized groups (arms)|Post-operative thru day 7|Number of patients randomized to each group|||number of doses||Full Range|Median
2794218|NCT00561145|Secondary|Appetite/Satiety Hormones and Questionnaires||Before and after the energy restriction period.|||||||
2778677|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778678|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778679|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778680|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778681|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline, Week 52 plus 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778682|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778683|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778684|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||millimeters||Standard Error|Mean
2778685|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778686|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2784950|NCT00630539|Secondary|Mean Change From Baseline in Follicle Stimulating Hormone Levels||Week 12|ITT|||U/L||Standard Deviation|Mean
2778687|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778688|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||mg/cm^3||Standard Error|Mean
2778689|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778690|NCT00679939|Post-Hoc|Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778691|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778692|NCT00679939|Post-Hoc|Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778693|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778694|NCT00679939|Post-Hoc|Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778714|NCT00679939|Secondary|Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778695|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778696|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778697|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778698|NCT00679939|Post-Hoc|Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778699|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778700|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778701|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778715|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2784592|NCT00633087|Secondary|Overall Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
2778702|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 days) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for all of the DXA measurements.|||percent change||Standard Error|Mean
2778703|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or Week 76 + 10 days ) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 10 days, and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 10 days after initiating OL MET or at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for the DXA lumbar spine measurement.|||percent change||Standard Error|Mean
2778704|NCT00679939|Other Pre-specified|Percent Change in Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778705|NCT00679939|Other Pre-specified|Percent Change in Percentage of Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778706|NCT00679939|Secondary|Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778707|NCT00679939|Secondary|Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778708|NCT00679939|Secondary|Percent Change in Free Testosterone From Week 52 to Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778709|NCT00679939|Secondary|Percent Change From Baseline in Free Testosterone at Week 52 and Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778710|NCT00679939|Secondary|Percent Change in Total Testosterone From Week 52 to Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778711|NCT00679939|Secondary|Percent Change From Baseline in Total Testosterone at Week 52 and Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778712|NCT00679939|Secondary|Percent Change in Serum Estradiol From Week 52 to Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778713|NCT00679939|Secondary|Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2779442|NCT00673933|Primary|Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment||4 weeks after last treatment, 6 weeks after baseline||||participants|||Number
2778716|NCT00679939|Secondary|Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778717|NCT00679939|Secondary|Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778718|NCT00679939|Secondary|Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778719|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778720|NCT00679939|Secondary|Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. One participant did not have P1NP measured.|||percent change|||Number
2778721|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.|||percent change|||Number
2778722|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET and Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for all of the DXA measurements.|||percent change||Standard Error|Mean
2778723|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 10 days and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.|||percent change||Standard Error|Mean
2778724|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.|||percent change||Standard Error|Mean
2778725|NCT00679939|Primary|Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52+10 days and Week 76+10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2797686|NCT00538642|Secondary|Systolic Blood Pressure||Baseline||||mm Hg||Standard Deviation|Mean
2778726|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 76+10 days|Safety Population. Only evaluable participants with a value at baseline and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.|||percent change||Standard Error|Mean
2778727|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET are included in this primary analysis.|||percent change||Standard Error|Mean
2778728|NCT00679913|Secondary|Morbidity|Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy|within 2 years after surgery||||participants|||Number
2778729|NCT00679913|Primary|Survival|comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery|2 year after surgery||||participants|||Number
2778730|NCT00679783|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.||||Days||Full Range|Median
2778731|NCT00679783|Secondary|CA-125 Levels (Ovarian Cancer Patients Only)|A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.|24 weeks||||Percentage of participants||95% Confidence Interval|Number
2778732|NCT00679783|Secondary|Best Percentage Change From Baseline in Tumour Size|The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.||||Percentage||Full Range|Median
2778733|NCT00679783|Secondary|Duration of Response|Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.||||Days||Full Range|Median
2778734|NCT00679783|Secondary|Disease Control Rate (DCR)|Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)|16 Weeks||||Percentage of participants||95% Confidence Interval|Number
2778735|NCT00679783|Primary|Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines|Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.||||Percentage of participants||95% Confidence Interval|Number
2778736|NCT00679627|Secondary|Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.|||Scores on scale||Standard Deviation|Mean
2778737|NCT00679627|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)|The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation [each with a maximum score of 5] was used). A higher score compared with baseline indicates less impairment.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.|||Scores on scale||Standard Deviation|Mean
2779207|NCT00676182|Primary|Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)|Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.|Baseline, 6 months, 12 months|Only participants with data at the specified time points are included in the analysis.|||units on a scale||Standard Deviation|Mean
2778739|NCT00679627|Secondary|Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The table below presents the number of days that caregiving activities were provided during the past week.|Baseline, Months 12 and 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.|||Days||Standard Deviation|Mean
2778740|NCT00679627|Secondary|Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|"The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants home with friend or relative using the APAS-CarB."|Baseline, Months 12 and 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure.|||Percentage of participants|||Number
2778741|NCT00679627|Secondary|Change From Baseline in Disability Assessment in Dementia (DAD) Scores|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.|||Scores on scale||Standard Deviation|Mean
2778742|NCT00679627|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 6|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.|||Scores on scale||Standard Deviation|Mean
2778743|NCT00679627|Primary|The Number of Deaths Reported in Participants|An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.|Up to 2 years|The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.|||Number of Participants|||Number
2778744|NCT00679627|Primary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.|||Scores on scale||Standard Deviation|Mean
2778745|NCT00679549|Primary|Left Ventricular Ejection Fraction (LVEF)|"Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) *100.~the measurement unit of LVEF is %."|at baseline and 3 days post randomization||||percent ejection fraction||Standard Deviation|Mean
2778746|NCT00679432|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.~As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).|||percentage of patients||95% Confidence Interval|Number
2778747|NCT00679432|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).|||percentage of patients||95% Confidence Interval|Number
2778748|NCT00679432|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).|||percentage of patients||95% Confidence Interval|Number
2778761|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Ke value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||hr^(-1)||Full Range|Median
2784593|NCT00633087|Secondary|Progression-free Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
2778749|NCT00679380|Secondary|Endoscopic Improvement.|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.~As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.|||percentage of patients||95% Confidence Interval|Number
2778750|NCT00679380|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.|||percentage of patients||95% Confidence Interval|Number
2778751|NCT00679380|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.|||percentage of patients||95% Confidence Interval|Number
2778752|NCT00679367|Secondary|Number of Participants Removed From Study Due to Toxicities|Number of study participants removed from study treatment due to toxicities|One year|All patients who have had at least one dose of drug.|||Participants|||Count of Participants
2778753|NCT00679367|Secondary|Number of Organs Improved or Stable Based on Description Below:|"Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.~Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.~Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.~Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.~Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.~Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy."|one year||||number of organs stable or improved|involved organs||Number
2778754|NCT00679367|Primary|Number of Participants With Hematologic Response|"Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.~Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more."|one year|Participants who completed at least 3 cycles of treatment|||participants|||Number
2778755|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by Systemic Clearance|Cilengitide systemic exposure as measured by systemic clearance is used in this genotype-phenotype analysis. The ABCG2 (breast cancer resistance protein; BCRP) Exon 5 genotype is coded as 0/1/2 based on the number of G alleles.|At baseline|The analysis includes 12 eligible patients with both systemic clearance data and ABCG2 Exon 5 data available.|||Spearman’s Correlation|||Number
2778756|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by AUC|Cilengitide systemic exposure as measured by AUC is used in this genotype-phenotype analysis. The ABCG2 (breast cancer resistance protein; BCRP) Exon 5 genotype is coded as 0/1/2 based on the number of G alleles.|At baseline|The analysis includes 12 eligible patients with both AUC data and ABCG2 Exon 5 data available.|||Spearman’s Correlation|||Number
2778757|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by Systemic Clearance|Cilengitide systemic exposure as measured by systemic clearance is used in this genotype-phenotype analysis. The ABCB1 (P-glycoprotein; P-gp) Exon 26 genotype is coded as 0/1/2 based on the number of T alleles.|At Baseline|The analysis includes 12 eligible patients with both systemic clearance data and ABCB1 Exon 26 data available.|||Spearman's Correlation|||Number
2778758|NCT00679354|Secondary|Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by AUC|Cilengitide systemic exposure as measured by AUC is used in this genotype-phenotype analysis. The ABCB1 (P-glycoprotein; P-gp) Exon 26 genotype is coded as 0/1/2 based on the number of T alleles.|At baseline|The analysis includes 12 eligible patients with both AUC data and ABCB1 Exon 26 data available.|||Spearman's correlation|||Number
2778759|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Cl value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||L/hr/m^2||Full Range|Median
2778760|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one t1/2 value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||hours||Full Range|Median
2778762|NCT00679354|Secondary|Pharmacokinetic Parameter of Cilengitide in Plasma: Volume of Central Compartment (Vc)|Cilengitide plasma concentration-time data are fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. For each patient, samples collected at different time points are used to derive one Vc value per patient.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide|All 18 patients consenting for pharmacokinetic study are included in this analysis.|||L/m^2||Full Range|Median
2778763|NCT00679354|Secondary|Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Rate of individual toxicity including that of symptomatic ITH will be summarized in each course of treatment using standard descriptive statistical methods.|Up to 5 years|Twenty-nine eligible patients are included in the analysis. One patient was excluded due to ineligibility.|||percent of pts with symptomatic ITH|||Number
2778764|NCT00679354|Secondary|Time to Death (TTD)|The distribution of TTD will be analyzed separately using PL estimate.|Time from study enrollment to death from any cause, assessed up to 5 years|Twenty-nine eligible patients are included in the analysis.|||Days||Inter-Quartile Range|Median
2778765|NCT00679354|Secondary|Time to Treatment Failure (TTF)|The distribution of TTF will be analyzed separately using PL estimate.|Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years|Twenty-nine eligible patients are included in the analysis.|||Days||Inter-Quartile Range|Median
2778766|NCT00679354|Secondary|Time to Tumor Progression (TTP)|The distribution of TTP will be analyzed separately using product limit (PL) estimate.|Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years|29 eligible patients are included in the analysis.|||Days||Inter-Quartile Range|Median
2778767|NCT00679354|Primary|Objective Response to Cilengitide|Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.|Up to 16 weeks|Six patients are considered inevaluable for objective response (including one ineligible patient) and excluded from analysis.|||participants|||Number
2778768|NCT00679341|Secondary|Plasma Concentration of Free Emtansine|Plasma samples were collected from all 67 patients in the trastuzumab emtansine group 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. The plasma samples were assayed for free emtansine in a mass-spectrometric assay.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.|||ng/mL||Standard Deviation|Mean
2778769|NCT00679341|Secondary|Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab|Serum samples were collected from all 67 patients enrolled in the trastuzumab emtansine arm using sparse pharmacokinetic sampling. Blood samples were collected prior to dosing and 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. Serum samples were assayed for trastuzumab emtansine and total trastuzumab (sum of unconjugated trastuzumab and emtansine conjugated to trastuzumab) in indirect sandwich ELISAs. The area under the concentration-time curve (AUC) was estimated based on non-compartmental analysis using WinNonlin (Version 5.2.1) software.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.|||day•μg/mL||Standard Deviation|Mean
2778770|NCT00679341|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first documentation of a ≥ 5-point decrease from baseline in the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) subscale score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B questionnaire is a valid and reliable measure of symptoms associated with breast cancer. The TOI-PFB is a 24-item subscale generated using 3 subsections (Physical Well-Being [7 items], Functional Well-Being [7 items], and Additional Concerns [10 items]) from the FACT-B questionnaire. Patients responded to each item on a scale of 0-4 (Not at all-Very much). The total score ranged from 0 to 96. A higher score indicates fewer symptoms. A positive change score indicates improvement.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with a Baseline and at least 1 post-Baseline valid score.|||Months||95% Confidence Interval|Median
2778771|NCT00679341|Secondary|Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|CB was defined as an objective response (complete response [CR], partial response [PR]) or stable disease (SD) for 6 months after randomization. For target lesions (TL), CR=the disappearance of all TL; PR=at least a 30% decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of TL, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions. For non-TL, CR=the disappearance of all non-TL; PR=the persistence of 1 or more non-TL; SD=the persistence of 1 or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits; PD=the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TL.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measurable disease at Baseline.|||Percentage of patients||90% Confidence Interval|Number
2778781|NCT00679289|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAEs)|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). TEAEs were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Causal relationship of each TEAE to study treatment was evaluated by the investigator separately for HDI and KW2871. Regimen-limiting toxicity was defined as an HDI-related dose-limiting toxicity (DLT) that required more than 2 dose reductions of HDI during the induction phase or the first 4 weeks of the maintenance phase, or any KW2871- or regimen-related DLT.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871.|||Participants|||Count of Participants
2784951|NCT00630539|Secondary|Mean Change From Baseline in Luteinizing Hormone Levels||Week 12|ITT|||U/L||Standard Deviation|Mean
2778772|NCT00679341|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline. Only patients with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2778773|NCT00679341|Secondary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline.|||Percentage of patients||90% Confidence Interval|Number
2778774|NCT00679341|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day.|Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
2778775|NCT00679341|Primary|Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)|PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
2778776|NCT00679302|Secondary|New Lesion Development and Spread of Skin Abscesses (on Subject)|The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.|10-14 days and 3 month||||participants|||Number
2778777|NCT00679302|Primary|Skin Abscess Resolution||10-14 days||||participants||95% Confidence Interval|Number
2778778|NCT00679289|Secondary|Maximum KW2871 Antibody Levels in Plasma Following the First Infusion|Blood samples for pharmacokinetic (PK) measurements were collected at baseline and before and 30 minutes after the initial KW2871 infusion on Day 3. The KW2871 antibody protein in patient serum was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantitation was determined to be 100 ng/mL.|At Baseline and Study Day 3|Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and had at least 1 plasma sample evaluated for KW2871 antibody levels.|||µg/mL||Standard Deviation|Mean
2778779|NCT00679289|Secondary|Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871|Blood samples were collected for the analysis of HACA at baseline, on Days 29, 115, 143, 171, 199, 227, 255, 283, 311, 339, and at the End of Study visit. Measurement of HACA development in plasma was performed with a BIAcore 2000 biosensor (Biacore AB, Uppsala, Sweden), using the BDF TM015 method. HACA positivity was defined as an increase in binding evident in the test channel but not in the control channel, with positivity assigned for values exceeding a uniform test threshold.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and had at least 1 post-baseline plasma sample evaluated for HACA.|||Participants|||Count of Participants
2778780|NCT00679289|Secondary|Number of Patients With Best Overall Tumor Response|Tumor responses were evaluated using whole body computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0) at Screening, on Days 29, 57, 85, 115, 143, 171, 227, 283, 339, and at the End of Study Visit. Patients who were treated beyond 49 weeks were to undergo clinical and radiologic assessments per the standard of care. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871.|||Participants|||Count of Participants
2778891|NCT00678418|Primary|Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)|Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.|20 weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (Intent-to-treat [ITT] population).|||Percentage of opioid-free weeks||Inter-Quartile Range|Median
2778782|NCT00679289|Primary|Median Progression-free Survival (PFS) With 95% Confidence Intervals|PFS was calculated from the date of the first infusion to the date of documented progression or death, whichever occurred first. PFS analyses were performed using Kaplan-Meier methods for all patients combined and for patients in Cohort 3. Based on published results from Phase 3 randomized clinical trials in patients with metastatic melanoma at the time of study initiation, 2.5 months was estimated as a conservative (i.e., somewhat high) external standard of median PFS. The intent of this study was to improve this standard by ≥ 70% to a median PFS of ≥ 4.3 months for patients treated with KW2871 combined with HDI. If the therapeutic target of 4.3 months for median PFS represented the true underlying treatment effect of KW2871 plus HDI, then 23 patients would provide 80% power to detect a statistically significant improvement (α = 0.05; 1-sided test) over the 2.5-month external standard.|From baseline through up to 17 months post-baseline|Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and experienced a PFS event (progression or death).|||months||95% Confidence Interval|Median
2778783|NCT00679263|Secondary|FEV1 Percent Predicted Changes From Base Line|The primary efficacy variable will be the change from baseline in FEV1, expressed as percent of predicted at hour 1 after the start of the infusion. Analysis of all other variables at all other time points will be considered secondary.|Day 1 to Day 2||||FEV1 percent predicted||Standard Deviation|Mean
2778784|NCT00679263|Primary|Number of Patients Reported to Have Adverse Events||Day 1 to Day 2||||participants|||Number
2778785|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Investigator Assessment|Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment.|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Patients without a post-baseline tumor assessment were considered to have experienced no clinical benefit.|||percentage of participants||95% Confidence Interval|Number
2778786|NCT00679211|Secondary|Duration of Objective Response Based on Investigator Assessment|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.|||months||95% Confidence Interval|Median
2778787|NCT00679211|Secondary|Progression-free Survival Based on Investigator Assessment|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population|||months||95% Confidence Interval|Median
2778788|NCT00679211|Secondary|Objective Response Based on Investigator Assessment|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator.~CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.~PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to be non-responders.|||percentage of participants||95% Confidence Interval|Number
2778789|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review|"Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months.~Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to have experienced no clinical benefit.|||percentage of participants||95% Confidence Interval|Number
2778867|NCT00678587|Secondary|Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results|A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site.|Screening, Baseline, Day 15, and Withdrawal|Safety Population. Data were missing for some participants.|||participants|||Number
2778790|NCT00679211|Secondary|Progression-free Survival as Assessed Through Independent Radiologic Review|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility.~For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population.|||months||95% Confidence Interval|Median
2778791|NCT00679211|Secondary|Duration of Objective Response as Assessed Through Independent Radiologic Review|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.|||months||95% Confidence Interval|Median
2778792|NCT00679211|Primary|Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST).~CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.~PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions.~The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled)."|From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).|Treated population (patients who received at least one dose of T-DM1). Participants without a post-baseline tumor assessment were considered to be non-responders.|||percentage of participants||95% Confidence Interval|Number
2778793|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Fold Change in IgG.|Number and proportion of subjects with 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).|From baseline (pre-dose) to Day 28.|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
2778794|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of ASCs Secreting IgA.|Number and proportion of subjects with ≥ 4 ASCs per 10^6 PBMCs at Day 7 secreting IgA specific for S. typhi LPS (detected by ELISPOT).|Day 7.|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
2778795|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of Antibody Secreting Cells (ASCs) Secreting IgA and/or Fold Change in IgG.|Number and proportion of subjects with ≥ 4 ASCs per 10^6 peripheral blood mononuclear cells (PBMCs) at Day 7 secreting IgA specific for S. typhi LPS (detected by enzyme-linked immunospot assay [ELISPOT]) AND/OR 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).|At Day 7 (IgA); and from baseline (pre-dose) to Day 28 (IgG).|ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
2778796|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.|Number and proportion of subjects with an increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 7, 14 or 28. Serum IgG was assayed using ELISA.|From baseline (pre-dose) to Days 7, 14, or 28.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 14.|||Participants|||Count of Participants
2778797|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.|Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28. Serum IgG was assayed using ELISA.|From baseline (pre-dose) to Days 14 or 28.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
2778798|NCT00679172|Secondary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.|Number and proportion of subjects with increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgA was assayed using ELISA.|From baseline (pre-dose) to Days 7 or 14.|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
2779546|NCT00673309|Secondary|Incidence of Morbidity and Mortality|Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.|Admission to burn unit to discharge|||||||
2778799|NCT00679172|Primary|Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG and/or IgA Antibodies for S. Typhi Lipopolysaccharide (LPS).|Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).|From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).|ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.|||Participants|||Count of Participants
2778800|NCT00679172|Primary|Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC‾ssaV‾) ZH9.|Number of subjects having shedding in stool of S. typhi (Ty2 aroC‾ssaV‾) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.|Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).|Safety Population: All subjects who received a dose of study medication.|||participants|||Number
2778801|NCT00679172|Primary|Number and Proportion of Subjects Experiencing Bacteraemia.|Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC‾ssaV‾) ZH9.|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||Participants|||Count of Participants
2778802|NCT00679172|Primary|Number of Subjects Reporting Treatment-related TEAEs.|"Number of subjects having TEAEs considered by the principal investigator to be possibly or probably related to treatment."|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||participants|||Number
2778803|NCT00679172|Primary|Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.|Number of subjects having clinically significant changes in clinical laboratory test parameters.|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||participants|||Number
2778804|NCT00679172|Primary|Number and Proportion of Subjects Experiencing Symptomatic Fever.|Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.|From start of dosing to 14 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||Participants|||Count of Participants
2778805|NCT00679172|Primary|Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.|Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).|From start of dosing to 28 days post-dosing.|Safety Population: All subjects who received a dose of study medication.|||Participants|||Count of Participants
2778806|NCT00679081|Secondary|Subject Preference Measures||6-months|||||||
2778807|NCT00679081|Secondary|Post-Surgical Subject Comfort Measures||4-weeks|||||||
2778808|NCT00679081|Secondary|Aesthetic Measures||6-months|||||||
2778809|NCT00679081|Secondary|Periodontal Health Measures||6-months|||||||
2778810|NCT00679081|Primary|Overall Rate of Adverse Events (AEs)|"Adverse events were collected at every visit throughout the 6 month duration.~An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition."|6-month||||participants|||Number
2778811|NCT00679055|Secondary|Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.|up to 14 weeks|All enrolled participants who received at least one dose of study drug.|||Particpants|||Number
2778812|NCT00679055|Secondary|Change From Baseline in Messenger Ribonucleic Acid (mRNA)|mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.||||||
2778813|NCT00679055|Primary|Change From Baseline in Cluster of Differentiation 68 (CD68)|CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.||||||
2778814|NCT00679029|Primary|Overall Survival as Assessed by the Kaplan and Meier Method||From the date of first treatment to the date of death, assessed up to 100 months||||percentage of participants||95% Confidence Interval|Number
2778815|NCT00679029|Primary|Disease-free Survival as Assessed by the Kaplan and Meier Method||From the date of first treatment to the date of disease progression/recurrence, second cancer, or death, whichever came first, assessed up to 5 years|report below of estimated disease free survival at 5 years|||percentage of participants||95% Confidence Interval|Number
2778816|NCT00679029|Primary|Count of Participants With Related SAEs by NCI Common Toxicity Criteria v3.0|Assess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation.|through study completion, an average of 10 months||||Participants|||Count of Participants
2778817|NCT00679029|Primary|Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions|This outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express HER 2/neu|through study completion, an average of 10 months||||percentage of participants||95% Confidence Interval|Number
2784952|NCT00630539|Secondary|Mean Change From Baseline in Estradiol Levels||Week 12|ITT|||nmol/L||Standard Deviation|Mean
2778818|NCT00678899|Secondary|AzBio Sentence Score-Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:~The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported."|6 Months Postactivation||||percentage of subjects|||Number
2778819|NCT00678899|Secondary|Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:~The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported."|6 Months Postactivation||||percentage of subjects|||Number
2778820|NCT00678899|Primary|AzBio Sentence Score in Noise - Treated Ear (Co-Primary)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.~The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score."|6 Months Postactivation||||percentage of words correct||Standard Deviation|Mean
2778821|NCT00678899|Primary|Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.~The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study."|6 Months Postactivation||||percentage of words correct||Standard Deviation|Mean
2778822|NCT00678886|Secondary|Percent Change From Baseline in CD3/TCR Modulation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8|The extent of modulation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites.CD3/TCR complexes on CD4+ and CD8+ T cells were detected with a non-competing antibody. Changes in the MESF of TCR expression was a direct measurement of TCR modulation. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (Pre-dose Day 1), Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
2778823|NCT00678886|Secondary|Percent Change From Baseline in CD3/TCR Saturation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8|The extent of saturation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of free CD3 sites on CD4+ T cells and CD8+ T cells was direct measurement of saturation of the CD3/TCR complex on CD4+ T cells and CD8+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (Pre-dose Day 1), Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
2778824|NCT00678886|Secondary|Percent Change From Baseline in Cell-bound Otelixizumab on CD4+ T Cells at Day 1, Day 4, Day 8|The amount of cell-bound otelixizumab was determined by flow cytometry. The extent of T cell receptor alpha beta (TCRαβ) expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. Free otelixizumab binding sites (sites not occupied by otelixizumab) were detected by staining with biotinylated otelixizumab. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of bound antibody on CD4+ T cells was a direct measurement of cell-bound otelixizumab on CD4+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Baseline (pre-dose on Day 1), Day 4 and Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
2778848|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment|Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
2779549|NCT00673257|Secondary|Relationship Between Pharmacokinetics, and Genetic Polymorphisms|Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype|Length of Study|||||||
2778825|NCT00678886|Secondary|Percent Change From Baseline in Circulating Peripheral Lymphocytes CD4+CD25+FoxP3+ T Cells and CD4+CD25hiFoxP3+ T Cells in Type 1 Diabetes Mellitus (TIDM) up to Month 12|Blood samples were drawn for lymphocyte subset evaluations at Baseline and at 2hours after EOI on Day 4, pre-dose and after E0I on Day 8, Day 14, Day 21, Day 28, Week 6, Week 8, Week 10, Week 12, Month 6 and Month 12. Percentages of relevant lymphocyte subsets were determined by flow cytometry. The lymphocyte subsets assessed included CD8+CD25+ T lymphocytes, as well as the subsets of lymphocytes of these type that were positive for FoxP3, a protein that was expressed at high levels in the cytoplasm of regulatory T cells. CD4+CD25hiFoxP3+ T lymphocytes, a cell type was of interest because it played a regulatory role in T1DM. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (pre-dose on Day 1) and up to 12 Months|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Full Range|Median
2778826|NCT00678886|Secondary|Change From Baseline in Level of Cytokines Interleukin (IL-6), IL-10 and Tumor Necrosis Factor-alpha (TNF-a) at Day 1, Day 4, Day 8|Levels of cytokine (TNFα, IL-6, IL-10) were measured at Baseline and at 2 hours after end of infusion (EOI) on Day 1, Day 4, Day 8 . Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.|Day 1, Day 4, Day 8|ITT population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter||Standard Error|Mean
2778827|NCT00678886|Secondary|Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use at Month 6 and Month 12|O'Brien analyses will be performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily Insulin use in the otelixizumab group compared with the placebo group at Months 6 and12. For the O'Brien mean rank analysis at a particular time point, HbA1c and insulin use will be ranked from smallest to largest, and C-peptide AUC will be ranked from largest to smallest. For each participant, the C-Peptide AUC, ranks for HbA1c and insulin use were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.|Month 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Composite rank score||Standard Deviation|Mean
2778828|NCT00678886|Secondary|Composite Rank Summary for HbA1c and Exogenous Insulin Use at Month 6 and Month 12|O'Brien mean rank analyses was performed on a two-part composite of the baseline-adjusted HbA1c level and the baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6, 12. For the O'Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) was ranked from smallest to largest, and adjusted mean daily insulin use values were ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.|Month 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Composite rank score||Standard Deviation|Mean
2778829|NCT00678886|Secondary|Change From Baseline in Average Daily Risk Range (ADRR) at Week 12 and Months 6 and 12.|Average daily risk range is a measure for evaluation of blood glucose variability that was designed to be equally sensitive to hypoglycemia and hyperglycemia. The ADRR was assessed over 30-day periods prior to Baseline and at key visits Week 12 and Months 6 and 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Week 12 and Months 6 and 12.|Baseline (Day 1) and Week 12, Months 6 and 12.|ITT population.|||Ratio||Standard Error|Least Squares Mean
2778830|NCT00678886|Secondary|Number of Participants With Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12|Percentage of hyperglycemic excursions was calculated as the total number of observations that exceed the hyperglycemic excursion boundary (i.e. > HGTLV) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data for number of participants with their percentages are presented.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2778831|NCT00678886|Secondary|Magnitude of Greatest Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|The greatest hyperglycemic excursions during an interval was calculated as the largest recorded glucose level in the interval minus the hyperglycemic tolerance limit value (HGTLV). If a participant had data recorded during the interval but did not have a value above the HGTLV, the participants greatest hyperglycemic excursion for that interval was 0 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.|||milligrams per deciliter||Standard Error|Mean
2778849|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment|Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|Daily diary entries throughout 10 week study period|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
2778832|NCT00678886|Secondary|Number of Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|The event frequency of glucose measurements that were hyperglycemic excursions were calculated on a per participant basis using the number of occurrences where blood glucose was greater than the hyperglycemic tolerance limit. There were 3 hyperglycemic tolerance limits considered: 200 mg/dL, 130 mg/dL and 100 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Hyperglycemic excursions||Standard Error|Mean
2778833|NCT00678886|Secondary|Number of Participants With Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12|Percentage of hypoglycemic excursions was calculated as the total number of observations that exceed the hypoglycemic excursion boundary (i.e.<= 70 mg/dL) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data has been presented for number of participants with their percentages having hypoglycemic excursion.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2778834|NCT00678886|Secondary|Magnitude of Greatest Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12.|"The greatest hypoglycemic excursions during an interval was calculated as 70 mg/dL minus the lowest recorded glucose level in the interval. If a participant had data recorded during the interval but did not have a value below 70 mg/dL, the participants greatest hypoglycemic excursion for that interval was 0 mg/dL.~Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected."|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.|||milligrams per deciliter||Standard Error|Mean
2778835|NCT00678886|Secondary|Number of Hypoglycemic Excursions (<=70 mg/dL) With Most Complete Glucose at Week 12 and Months 6 and 12.|The event frequency of glucose measurements that were hypoglycemic excursions were calculated per participant basis, using the number of occurrences where blood glucose was less than or equal to 70 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.|Week 12 and Months 6 and 12.|ITT population. Only those participants available at the specified time points were analyzed.|||Hypoglycemic excursions||Standard Error|Mean
2778836|NCT00678886|Secondary|Number of Participants With Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12|Hypoglycemic events reported by participants were classified as defined by the ADA Workgroup on Hypoglycemia as Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration (PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL. Only categories with values are presented.|Upto Month 12|ITT population. Data has been presented for number of participants with their percentages with hypoglycemic events defined by hypoglycemic event categories from Baseline upto month 12.|||Participants|||Count of Participants
2778837|NCT00678886|Secondary|Number of Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12|Hypoglycemic events reported by participants were classified as defined by the American Diabetes Association (ADA) Workgroup on Hypoglycemia as follows: Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration(PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL.|Upto Month 12|ITT population.|||Hypoglycemic events|||Number
2778838|NCT00678886|Secondary|HbA1c Level at Week 12 and Months 6 and 12|HbA1c levels were recorded at Screening, Baseline (Day 1), Day 28, Week 8, Week 12, Months 4 to 12 and Month 24. Data has been presented for HbA1c levels at Week 12 and Months 6 and 12.|Week 12 and Months 6 and 12|ITT population.|||Percentage||Standard Error|Least Squares Mean
2784594|NCT00633087|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
2778839|NCT00678886|Secondary|Mean Daily Insulin Use at Week 12 and Months 6 and 12.|Participants recorded their daily insulin use in their electronic diaries. In particular, insulin was recorded thoroughly and accurately for at least 7 consecutive days during the 2 weeks before the visits at Baseline, Week 12, and Months 6 and 12. During each of these visits, the investigator/designee accessed the invivodata DiaryPRO web site to review insulin-use data for the previous 2-week period to ensure completeness. If errors/gaps were identified (e.g., if the participant did not take insulin and not entered 0 units), the investigator/designee recorded the missing data from participant recall using a data clarification form (DCF). Paper diary to collect insulin use, were reviewed for completeness. Any missing data that could be recalled by the participant was entered. If the participant did not record any insulin use during the 2-week period before the visit, the site obtained an insulin use history for the previous 7 days and calculated the average daily insulin dose.|Week 12 and Months 6 and 12.|ITT population.|||IU/kg||Standard Error|Least Squares Mean
2778840|NCT00678886|Secondary|Number of Participants Who Were Responders for (Glycosylated Hemoglobin) HbA1c/Insulin Use Response at Week 12 and Months 6 and 12|A participant was considered a responder if, at the given time point, the participant had HbA1c<= 6.5%, and mean daily insulin use over 7 consecutive days < 0.5 international units per kilogram per day (IU/kg/day) during the 2 weeks preceding the visit. Data has been presented from number of participants with their percentages who were responders at Week 12 and Months 6 and 12.|Week 12 and Months 6 and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2778841|NCT00678886|Primary|Change From Baseline in 2-hour Mixed Meal Stimulated C-peptide Area Under Curve [AUC] (Normalized for 120-minute Time Interval) at Month 12|Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from Time 0 to 120 minutes, calculated using the trapezoidal rule. This reported AUC was normalized for time interval by dividing it by 120 minutes. This normalized AUC was calculated for each participant at Baseline, Week 12, and at Months 6, 12, 18, and 24. Data has been presented for meal stimulated C-peptide Area under assessment performed at Month 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Month 12.|Baseline (0-120 minutes on Day 1) and Month 12 (0-120 minutes)|Intent-to-treat (ITT) population, comprised of all participants who were randomized and received any part of at least 1 infusion of study drug.|||nanomoles per liter||Standard Error|Least Squares Mean
2778842|NCT00678834|Primary|"The Levels of TCT in the Tissues of Non-healthy Subjects and in the Tissue of Healthy Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)"||After at least 1 month of supplementation|Box plots were used to determine outliers defined as values . the 75th percentile plus 1.5 times the IQR or values , the 25th percentile minus 1.5 times the IQR (20). Outliers were identified and it was determined that laboratory procedural errors were the cause and thus removed from the analysis.|||nmol/g||Standard Deviation|Mean
2778843|NCT00678795|Secondary|Change From Baseline in the Mean Number of Daily Voids at the End of Treatment|Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
2778844|NCT00678795|Secondary|Patient's Global Impression of Change|Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The numbers who scored 1, 2, or 3 are presented.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
2778845|NCT00678795|Secondary|Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment|"Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = no problems and 10 = intolerable problems. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline."|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2778846|NCT00678795|Secondary|Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)|The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2778847|NCT00678795|Secondary|Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment|Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||pads used daily||Standard Deviation|Mean
2778866|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)|AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure.|Day 14|PK Subpopulation: all participants who were treated with eltrombopag and provided evaluable PK samples|||hour*micrograms (ug)/milliliter (mL)||95% Confidence Interval|Geometric Mean
2778850|NCT00678795|Primary|Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment|To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||number of daily episodes||Standard Deviation|Mean
2778851|NCT00678691|Primary|Brief Fatigue Inventory|This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue|8 weeks|last observation carried forward after power analysis calculated|||units on a scale||Standard Deviation|Mean
2778852|NCT00678652|Secondary|Total Antibody Response to the Parent Strain of Group B Meningococcus|Assess and characterize bactericidal activity and total antibody response against the vaccine strain and other strains of Group B Meningococcus induced by 3 injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.|126 days||||ug/mL||Full Range|Median
2778853|NCT00678652|Primary|Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine|Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 3rd dose of vaccine|84+7 days (visit 11)|Seroconversion is defined as a 4-fold or greater increase from baseline in antibody titer of bactericidal antibodies after 3 doses of vaccine|||Participants|||Count of Participants
2778854|NCT00678652|Primary|Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine|Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 2nd dose of vaccine|42+7 days (visit 7)|Seroconversion is defined as a 4-fold or greater increase from baseline in antibody titer of bactericidal antibodies after 2 doses (the first and second) of vaccine.|||Participants|||Count of Participants
2778855|NCT00678652|Primary|Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections|Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.|18 weeks. Days 0, 14, 56, 84, 98 and 126||||titers||Standard Deviation|Mean
2778856|NCT00678639|Secondary|Adverse Events During Magnetic Resonance Imaging (MRI) Scanning|Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.|Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.|Only participants undergoing Cardiac MRI scanning are eligible for this endpoint. Only 49 of the 53 participants randomized to observation unit arm underwent CMR testing. Nine participants in the usual care arm underwent CMR testing.|||Participants|||Number
2778857|NCT00678639|Secondary|Number of Participants Who Utilized the Indicated Health Care Procedures|Measured as self report, assessed during telephone follow-up.|30d, 3mo, 6mo, and 1 year|Data reported through 30 days. Follow-up with participants is ongoing. Results will be updated once follow-up is complete.|||Participants|||Number
2778858|NCT00678639|Secondary|The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging|The number of participants able to complete the planned imaging sequences will be measured.|Emergency Department (ED) arrival through hospital discharge|All participants randomized to the Observation Unit - Cardiac Magnetic Resonance Imaging (OU-CMR) arm were analyzed based on intention to treat.|||Participants|||Number
2778859|NCT00678639|Secondary|Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days|Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.|30 Days|4 participants (3 in the usual care group and 1 in the ED obs unit group) left Against Medical Advice (AMA) prior to completion of their evaluation and were excluded from this analysis. Analysis was per intention to treat.|||Participants|||Number
2778860|NCT00678639|Primary|Cost of Index Hospitalization|Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.|Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours|All participants were analyzed based on intention to treat.|||US Dollars||Inter-Quartile Range|Median
2778861|NCT00678587|Secondary|Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures|The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.|||unscheduled events||Standard Deviation|Mean
2778862|NCT00678587|Secondary|Mean Number of Days Spent in the Hospital|The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.|||days||Standard Deviation|Mean
2778863|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, CL/F|CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time.|Day 14|PK Subpopulation|||Liters/hour||95% Confidence Interval|Geometric Mean
2778864|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, t1/2|t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration.|Day 14|PK Subpopulation|||hours||95% Confidence Interval|Geometric Mean
2778865|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Cmax|Cmax is the steady state peak plasma concentration of a drug observed after its administration.|Day 14|PK Subpopulation|||ug/mL||95% Confidence Interval|Geometric Mean
2778906|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate a Regular Diet|The number and percent of patients whose post-operative diet has to a regular diet on post-operative days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.||||Participants|||Count of Participants
2778868|NCT00678587|Secondary|Number of Participants With Renal Function Abnormality|Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test.|Screening to Procedure +30 day follow-up or early withdrawal|Safety Population|||participants|||Number
2778869|NCT00678587|Secondary|Number of Participants With the Indicated Event Relating to Vision|The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart).|Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)|Safety Population: all randomized participants who received at least one dose of study medication. Data are missing for some participants.|||participants|||Number
2778870|NCT00678587|Secondary|Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant||Screening to Procedure +30 day follow-up or early withdrawal|Safety Population|||participants|||Number
2778871|NCT00678587|Secondary|Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations.|Screening to Procedure +30 day follow-up or early withdrawal|Safety population: all randomized participants who received at least one dose of study medication|||participants|||Number
2778872|NCT00678587|Secondary|Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.|||participants|||Number
2778873|NCT00678587|Secondary|Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.|||Gi/L||Full Range|Median
2778874|NCT00678587|Secondary|Number of Participants With the Indicated Number of Platelet Transfusions Administered|Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population|||participants|||Number
2778875|NCT00678587|Secondary|Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures|The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).|Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population|||participants|||Number
2778876|NCT00678587|Primary|Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures|A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.|Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|Intent-to-Treat (ITT) Population: all participants who were randomized to treatment|||participants|||Number
2778877|NCT00678574|Primary|Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment|GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.|2-3 months post-treatment w/ fluoxetine.|This study was conducted at Yale several years ago. Our group at UPenn only has basic information about this study. This includes the number of participants, which was 18, and that no adverse events occurred. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania.||||||
2778878|NCT00678535|Secondary|Safety - Number of Participants With Adverse Events (AEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.|||participants|||Number
2778879|NCT00678535|Secondary|Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2778880|NCT00678535|Secondary|Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2778881|NCT00678535|Secondary|Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments|The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC.|Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
2778882|NCT00678535|Secondary|Overall Survival (OS)|The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2778883|NCT00678535|Primary|Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2778884|NCT00678470|Primary|Number of Participants With Either or Both Intralesional Response and Systemic Response|Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.|22 weeks|Eighteen patients were enrolled in the study and 14 patients completed the entire 22-week protocol. Three patients were lost to follow-up. One patient was discontinued due to persistent elevated liver enzymes determined by the investigators as secondary to heavy alcohol use.|||Participants|||Count of Participants
2778885|NCT00678444|Secondary|Patient Satisfaction Scores - Visual Analogue Scores (VAS).|"Secondary study measures included a study-specific visual analog scales (VAS, range 0-100 mm) to assess comfort with Clean Intermittent Self-Catheterization (CISC) and opinions on the CISC video.~Higher VAS scores represent higher levels of comfort with CISC."|Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively||||participants|||Number
2778886|NCT00678444|Primary|State-Trait Anxiety Inventory-State Scores|"The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, I feel at ease or I feel upset. Responses ranged from 1 to 5 from not at all to very much so."|Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively||||units on a scale||Standard Deviation|Mean
2778887|NCT00678418|Secondary|Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24|Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). Change from baseline was calculated per subject as the percent of subjects' self-reported opioid-free days in Part A minus the percent of opioid-free days prior to the subjects' hospitalization for pre-study detoxification.|||Percentage of opioid-free days||Inter-Quartile Range|Median
2778888|NCT00678418|Secondary|Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)|Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).|||Percentage of participants who relapsed|||Number
2778889|NCT00678418|Secondary|Craving Score: Change From Baseline|"Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 (No craving) to 100 (highest possible craving)."|Baseline to 6 months (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).|||Units on a scale||95% Confidence Interval|Least Squares Mean
2797687|NCT00538642|Secondary|Abdominal Circumference||4-5 months||||cm||Standard Deviation|Mean
2778892|NCT00678392|Secondary|Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
2778893|NCT00678392|Secondary|Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
2778894|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score|FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
2778895|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score|FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.|Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)|"FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, n signifies those participants who were evaluable for the specified time points."|||Units on a scale||Standard Deviation|Mean
2778896|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis|Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."|||Participants|||Number
2778897|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry|Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."|||Participants|||Number
2778898|NCT00678392|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology|Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|From initiation of treatment up to follow-up period (up to 3 years)|"Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, n signifies number of participants available for specified categories for each arm respectively."|||Participants|||Number
2778907|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate Only a Soft Diet|The number and percent of patients whose post-operative diet has only advanced to a soft diet on post-operative days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|per group diet|||Participants|||Count of Participants
2778908|NCT00678379|Secondary|Number and Percent of Participants Able to Tolerate Only Liquids|The number and percent of patients whose post-operative diet has advanced to liquids only on post-op days 1, 3, 5 & 7|post-operative days 1,3,5 & 7.|per group data|||Participants|||Count of Participants
2778899|NCT00678392|Secondary|Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
2778900|NCT00678392|Secondary|Percentage of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
2778901|NCT00678392|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.|From initiation of treatment up to follow-up period (up to 3 years)|Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
2778902|NCT00678392|Secondary|Duration of Response (DR)|DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2778903|NCT00678392|Secondary|Objective Response Rate (ORR)|ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2778904|NCT00678392|Secondary|Overall Survival (OS)|OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2778905|NCT00678392|Primary|Progression-Free Survival (PFS)|PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.|From initiation of treatment up to follow-up period (up to 3 years)|FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2778909|NCT00678379|Secondary|Mean Visual Analog Scale Pain Number.|Visual analog pain scale range is 0-10 with 0=no pain and 10 = worst pain ever|in recovery room; post-operative days 1,3,5 & 7||||pain score||Full Range|Mean
2778913|NCT00678301|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the entire study period, from Month 0 to Month 3|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
2778914|NCT00678301|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
2778915|NCT00678301|Secondary|Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off|The cut-off for the assay was > 39.0°C.|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
2778916|NCT00678301|Secondary|Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all."|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
2778917|NCT00678301|Secondary|Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity."|Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines|The Total Vaccinated Cohort included all evaluable subjects.|||Participants|||Count of Participants
2778918|NCT00678301|Secondary|Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs).|The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration ≥ 10 and 100 milli-international units per milliliter (mIU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778919|NCT00678301|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|The seroprotection cut-off for the endpoint was an anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2778920|NCT00678301|Secondary|Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens|Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 1 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778921|NCT00678301|Secondary|Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)|Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 0.15 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778922|NCT00678301|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were measured and tabulated in microgram per milliliter (μg/mL). Cut-off for the assay was ≥ 0.15 μg/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2778923|NCT00678301|Secondary|Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens|A subject seroprotected against D/TT antigens was defined as a subject with an Anti-D/-TT antibody concentration ≥ 0.1 IU/mL.|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2779285|NCT00675584|Primary|Rate of Exacerbations Requiring Systemic Corticosteroids|The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up|Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numerator and denominator of the exacerbation rate|||events per years of follow-up||95% Confidence Interval|Mean
2778924|NCT00678301|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|The seroprotection cut-off for the assay was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international unit per milliliter (IU/mL).|At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2778925|NCT00678301|Secondary|Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)|Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).|At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778926|NCT00678301|Secondary|Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations|Anti-BPT antibody concentrations were expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations ≥ 15 EL.U/mL|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2778927|NCT00678301|Secondary|Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778928|NCT00678301|Secondary|Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778929|NCT00678301|Secondary|Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)|Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778930|NCT00678301|Secondary|Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19 A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations ≥ 0.2 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778931|NCT00678301|Secondary|Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778932|NCT00678301|Secondary|Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.2 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778944|NCT00678249|Secondary|Percent of Participants With Binary Restenosis|Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window (or the core lab could not assess the angiogram), then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
2784953|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index||Week 4|ITT|||percentage of superficial cells||Standard Deviation|Mean
2778933|NCT00678301|Secondary|Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2778934|NCT00678301|Secondary|Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes|Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titres||95% Confidence Interval|Geometric Mean
2778935|NCT00678301|Secondary|Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2778936|NCT00678301|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)|Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2778937|NCT00678301|Primary|Antibody Concentrations Against Protein D (Anti-PD Antibodies)|Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2778938|NCT00678301|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).|At Month 3, one month after the administration of the third dose of Synflorix vaccine|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. The ATP cohort for immunogenicity included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2778939|NCT00678288|Secondary|Overall Survival|Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
2778940|NCT00678288|Secondary|Duration of Response|Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
2778941|NCT00678288|Secondary|Time to Progression|Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
2778942|NCT00678288|Secondary|Response Rate|Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
2778943|NCT00678288|Primary|Progression-Free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.||||||
2784954|NCT00630539|Secondary|Mean Change From Baseline in Vaginal pH||Week 4|ITT|||pH||Standard Deviation|Mean
2778945|NCT00678249|Secondary|Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)|ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
2778946|NCT00678249|Secondary|Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)|ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
2778947|NCT00678249|Secondary|Percent of Participants With Access Circuit Primary Patency (ACPP)|ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
2778948|NCT00678249|Secondary|Percent of Participants With TAPP|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|2 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
2778949|NCT00678249|Secondary|Percent of Participants With Procedural Success|Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success|Index Procedure||||Percentage of Participants|||Number
2778950|NCT00678249|Secondary|Percent of Participants With Successful Delivery of the Device|The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.|Index Procedure|The PTA Only group was not analyzed for this outcome measure because it is for successful delivery of the FLAIR study device (PTA Only is the control arm).|||Percentage of Participants|||Number
2778951|NCT00678249|Secondary|Total Number of Adverse Events|The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.|6 month Follow-Up||||total events|||Number
2778952|NCT00678249|Primary|Percent of Participants With Treatment Area Primary Patency (TAPP)|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|6 month follow-up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.|||Percentage of Participants|||Number
2778953|NCT00678210|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.|||units on a scale||Standard Error|Mean
2778954|NCT00678210|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores and Total Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.|||units on a scale||Standard Error|Mean
2778955|NCT00678210|Secondary|Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF.|||percentage of participants|||Number
2778956|NCT00678210|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.|||percentage of participants|||Number
2778957|NCT00678210|Secondary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.|||percentage of participants|||Number
2778958|NCT00678210|Secondary|"Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of Clear or Almost Clear"|Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.|||percentage of participants|||Number
2778959|NCT00678210|Primary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
2778960|NCT00678080|Primary|The Number of Participants Who Achieved a Hemoglobin A1C <7%|The hemoglobin A1c level is an indicator of glycemic control—it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.|at the time of delivery|At the time of delivery, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 8 in the insulin arm.|||Participants|||Count of Participants
2778961|NCT00678080|Secondary|Number of Participants With Newborns Who Needed Neonatal Dextrose||Neonatal period||||Participants|||Count of Participants
2778962|NCT00678080|Secondary|Number of Participants Who Had a Newborn With Respiratory Distress Syndrome||Neonatal period||||Participants|||Count of Participants
2778963|NCT00678080|Secondary|Number of Participants With Shoulder Dystocia||At the time of delivery||||Participants|||Count of Participants
2778964|NCT00678080|Secondary|Number of Participants With Fetus With Macrosomia||At the time of delivery||||Participants|||Count of Participants
2778965|NCT00678080|Secondary|Number of Participants Who Had a Cesarean Section||At the time of delivery||||Participants|||Count of Participants
2778966|NCT00678080|Secondary|Number of Participants Who Failed Metformin Therapy|Those whose glucose levels were above target range thereby needing insulin therapy|Duration of pregnancy||||Participants|||Count of Participants
2778967|NCT00678080|Secondary|Number of Participants With Hypoglycemia|Defined as hypoglycemia as documented by neonatal chart based on health care provider description|During pregnancy||||Participants|||Count of Participants
2778968|NCT00678080|Secondary|Body Mass Index||at the time of delivery||||kg/m^2||Standard Deviation|Mean
2778969|NCT00678080|Primary|The Number of Participants Who Achieved a Hemoglobin A1C <7%|The hemoglobin A1c level is an indicator of glycemic control—it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.|during third trimester|During the third trimester, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 12 in the insulin arm.|||Participants|||Count of Participants
2778970|NCT00678041|Secondary|Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
2779286|NCT00675558|Secondary|Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area|Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax'(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].|4 years||||pmol/sec/μm^2||Standard Deviation|Mean
2778971|NCT00678041|Secondary|Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
2778972|NCT00678041|Secondary|Patient Perceptions Regarding CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|||||||
2778973|NCT00678041|Secondary|Adherence to CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
2778974|NCT00678041|Secondary|Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.|0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
2778975|NCT00678041|Secondary|Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
2778976|NCT00678041|Primary|Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation|Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.|6 to 8 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.||||||
2778977|NCT00678015|Post-Hoc|Disease Progression at End of Study|End-of-study imaging was assessed for disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Progressive Disease (PD)=At least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, End of treatment (2-19 cycles)|At the time of calculation, 1 patient was still on study after 29 cycles|||participants|||Number
2778978|NCT00678015|Post-Hoc|Change in Prostate Specific Antigen Doubling Time (PSADT)|PSADT was calculated using the formula natural log 2 divided by the slope of the natural log of the PSA versus time. Pretreatment PSADT was calculated using a minimum of 3 values; end of study PSADT incorporated all measured PSA values on study starting Cycle 2-Day 1 until the patient was removed from the study.|Cycle 2 through end of treatment (up to 29 months)|At the time of PSADT calculations, one participant was still on study at 29 months, and 11 participants' time on study had ranged from 2-19 months|||percentage change||Full Range|Median
2778979|NCT00678015|Post-Hoc|PSA Decline|Number of participants experiencing PSA decline during the first 3 treatment cycles|Baseline; Monthly, up to 29 months after beginning treatment||||participants|||Number
2778980|NCT00678015|Primary|Prostate Specific Antigen (PSA) Response According to Consensus Criteria|Participants who experienced a PSA decline of at least 50%, confirmed by a second PSA value 4 or more weeks later. The reference PSA for decline was a PSA measured within 2 weeks of beginning study treatment. If at most 1 PSA response was observed among the first 12 patients, then accrual would stop and the trial would close for futility.|Monthly, up to 29 months||||participants|||Number
2778981|NCT00677924|Secondary|Best Overall Response|Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16|Overall Study||||Participants|||Number
2778982|NCT00677924|Primary|Adverse Events|Number of patients experiencing an adverse event|Overall Study|Number of patients experiencing an adverse event|||participants|||Number
2778983|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides|Guidelines recommend that triglycerides be evaluated every 2 years|1 year||||percentage of days in the study period||Standard Deviation|Mean
2778984|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol|Guidelines recommend that HDL cholesterol be evaluated every 2 years|1 year||||percentage of days in study period||Standard Deviation|Mean
2778985|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol|Guidelines recommend that LDL cholesterol be evaluated every 2 years|1 year||||percentage of days in study period||Standard Deviation|Mean
2778986|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c|Guidelines recommend that blood glucose/HbA1c be evaluated every year|1 year||||percentage of days in the study period||Standard Deviation|Mean
2778987|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure|Guidelines recommend that blood pressure be evaluated every 3 months|1 year||||percentage of days in the study period||Standard Deviation|Mean
2778988|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index|Guidelines recommend that body mass index be evaluated every 3 months|1 year||||percentage of days in the study period||Standard Deviation|Mean
2779287|NCT00675558|Primary|Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake|The Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.|4 years||||pmol/sec||Standard Deviation|Mean
2778989|NCT00677833|Secondary|Percentage of Participants With PfCRT in True Failures|A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.|Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.||||||
2778990|NCT00677833|Secondary|Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status||Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.||||||
2778991|NCT00677833|Secondary|Time to Recurrence of Parasitemia|Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).|Baseline (Day 0) to Day 42|mITT population, including participants in the Ivory Coast center.|||Days||Full Range|Median
2778992|NCT00677833|Secondary|Change From Nadir Hemoglobin Level at Days 14, 28, and 42|Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.|Day 14, 28, 42|"mITT population. N = number of participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."|||g/dL||Standard Error|Mean
2778993|NCT00677833|Secondary|Nadir Hemoglobin Level|Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.|Day 0 through Day 3|mITT population, including participants in the Ivory Coast center.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2778994|NCT00677833|Secondary|Asexual Plasmodium Falciparum Parasite Clearance Time|Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.|||Hours||Full Range|Median
2778995|NCT00677833|Secondary|Fever Clearance Time|Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral).|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.|||Hours||Full Range|Median
2778996|NCT00677833|Secondary|Percentage of Participants With Gametocytologic Response|Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|"mITT population. N= participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."|||Percentage of participants|||Number
2778997|NCT00677833|Secondary|Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)|Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 7, 14, 21, 28, 35, 42|"mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."|||Percentage of participants|||Number
2778998|NCT00677833|Secondary|Percentage of Participants With LPF in PP Population (PCR-corrected)|LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants|||Number
2778999|NCT00677833|Secondary|Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)|LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants|||Number
2779000|NCT00677833|Secondary|Percentage of Participants With LCF in PP Population (PCR-corrected)|"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants|||Number
2779036|NCT00677365|Primary|Change in P. Aeruginosa Density|Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period|from baseline to end of treatment (28 days)|Modified Intent-to-Treat (MITT; patients who received at least one dose of study drug)|||log10 CFU/g sputum||Standard Error|Least Squares Mean
2779001|NCT00677833|Secondary|Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)|"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants|||Number
2779002|NCT00677833|Secondary|Percentage of Participants With ETF in PP Population (PCR-corrected)|"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia~Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P.falciparum) on Day 3 with fever or~Last available P.falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|PP population, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants|||Number
2779003|NCT00677833|Secondary|Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)|"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia~Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P. falciparum) on Day 3 with fever or~Last available P. falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|mITT population, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants|||Number
2779004|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in PP Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants||95% Confidence Interval|Number
2779005|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in the mITT Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.|||Percentage of participants||95% Confidence Interval|Number
2779006|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in PP Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.|||Percentage of participants||95% Confidence Interval|Number
2779007|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in the mITT Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.|||Percentage of participants||95% Confidence Interval|Number
2779008|NCT00677833|Primary|Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.|||Percentage of participants||95% Confidence Interval|Number
2794920|NCT00556933|Secondary|New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy||Two years||||participants|||Number
2779009|NCT00677833|Primary|Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population|ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter [mcL];fever/history of fever >=38 degree Celsius[C] [rectal],37.2 degree C [axillary] or >=37.5 degree C [oral] within last 24 hours).Participants in Ivory Coast center excluded from analysis.|||Percentage of participants||95% Confidence Interval|Number
2779010|NCT00677820|Secondary|Number of Subjects Reporting SAEs and SNMCs|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.~An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-180|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779011|NCT00677820|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.~An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-28|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779012|NCT00677820|Secondary|Number of Subjects Reporting Any AEs Post Treatment||Days 0-14|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779013|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14||Days 0-14|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779014|NCT00677820|Secondary|Number of Subjects Reporting Any Adverse Event (AE) Post-treatment||Days 0-7|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779015|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7||Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779016|NCT00677820|Primary|Number of Subjects Reporting Fever|Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.|Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
2779017|NCT00677807|Secondary|Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52|"The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.~SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant."|Weeks 36, 44 and 52|"Extension Intent-to-treat population consisting of all participants who received at least one dose of study drug. n in each of the categories is the number of participants with data at the given time point. Missing data were imputed using LOCF but not by more than 14 weeks and not by carrying forward scores within 4 weeks of treatment start."|||Score on a Scale||Standard Error|Least Squares Mean
2779018|NCT00677807|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."|||mmol/L||Standard Error|Least Squares Mean
2779019|NCT00677807|Primary|Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."|||mmol/L||Standard Error|Least Squares Mean
2779020|NCT00677807|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.~The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).~Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||participant|||Number
2779021|NCT00677807|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.~A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||participants|||Number
2779022|NCT00677807|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.~A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||participants|||Number
2779023|NCT00677807|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.|Week 52|Participants from the Extension Intent-to-treat population (consisting of all participants who received at least one dose of study drug) for whom data was available for this Outcome Measure. Missing data was imputed Last Observation Carried Forward.|||Liters||Standard Error|Least Squares Mean
2779024|NCT00677807|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.~Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.~High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.|||Participants|||Number
2779025|NCT00677690|Secondary|Respiratory Function|forced expiratory volume in 1 second (FEV1)|5 weeks||||percentage of predicted value||Standard Deviation|Mean
2779026|NCT00677690|Primary|Quadriceps Strength|Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.|5 weeks||||repetitions||Standard Deviation|Mean
2779027|NCT00677690|Secondary|Quality of Life|St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).|5 weeks||||units on a scale||Standard Deviation|Mean
2779028|NCT00677690|Primary|Exercise Capacity|6 minute walk test(6MWT)|5 weeks||||meters||Standard Deviation|Mean
2779029|NCT00677690|Secondary|Dyspnoea|The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.|5 weeks||||units on a scale||Standard Deviation|Mean
2779030|NCT00677534|Primary|Change in Monocyte VDR Expression With Vitamin D Therapy|Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.|Change from End of Washout to Week 12|Clinical pilot trial - proof of concept|||units on a scale||Standard Deviation|Mean
2779031|NCT00677365|Secondary|Changes in Susceptability Patterns of Isolated Organisms|All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value|from baseline until the end of the 28-day treatment period (28 days)|MITT|||ug/mL|Isolates||Number
2779032|NCT00677365|Secondary|Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)|Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant|from baseline to the end of the 28-day treatment period (28 days)|MITT|||units on a scale||Standard Error|Least Squares Mean
2779033|NCT00677365|Secondary|Change in FEV1 Percent Predicted|Change in the predicted percent of air the patient could exhale in one second|from baseline to the end of the treatment 28-day treatment period (28 days)|MITT|||Percent||Standard Error|Least Squares Mean
2779034|NCT00677365|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|Percent change in the amount of air the patient could exhale in 1 second|from baseline to end of the 28-day treatment period (28 days)|MITT|||Percent change||Standard Error|Least Squares Mean
2779035|NCT00677365|Secondary|Time to Administration of Other Anti-pseudomonal Antimicrobials|Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported|from baseline until final study visit (up to 56 days)|MITT|||days||95% Confidence Interval|Mean
2779288|NCT00675558|Primary|Size of Adipocytes|The mean diameters of omental adipocytes were measured|4 years||||µm||Standard Deviation|Mean
2779037|NCT00677352|Secondary|Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase|The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.|4 weeks|Completer Set : Subset of patients in the EES who had a PAS rating at Week 16.|||Percentage of participants|||Number
2779038|NCT00677352|Secondary|Summary of Adverse Events in Tapering Phase|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.|4 weeks|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.|||Participants|||Number
2779039|NCT00677352|Secondary|Number of Participants With Summary of Adverse Events in Treatment Phase|Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.|1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.|||Participants|||Number
2779040|NCT00677352|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase|"The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items.~The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52."|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||Scores on a scale||Standard Deviation|Mean
2779041|NCT00677352|Secondary|Mean Change From Baseline in Panic Attack at the End of Treatment Phase|Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||panic attacks per week||Standard Deviation|Mean
2779042|NCT00677352|Secondary|Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement|"The ratings were rated to compare with baseline by 7-point  1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.~Responder was defined as number of participants who were assessed as very much improved or  much improved."|12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||Percentage of participants|||Number
2779043|NCT00677352|Primary|Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase|Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"|||Scores on scale||95% Confidence Interval|Least Squares Mean
2779044|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 24 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|24 months follow-up||||proportion of participants||95% Confidence Interval|Number
2779045|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 12 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|12 months follow up||||proportion of participants||95% Confidence Interval|Number
2779046|NCT00677235|Secondary|Post-intervention Secondary Patency at 6 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|6 month follow-up||||proportion of participants||95% Confidence Interval|Number
2779047|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 6 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|6 month follow up||||proportion of participants||95% Confidence Interval|Number
2779066|NCT00677092|Secondary|Change From Baseline in Maximal Extension of Elbows and Knees||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
2779433|NCT00674154|Primary|Decrease in Preoperative P-PTH|Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.|25 weeks||||pmol/l||Standard Error|Mean
2779048|NCT00677235|Secondary|Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.|24 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.|||Months/intervention||Standard Deviation|Least Squares Mean
2779049|NCT00677235|Secondary|Post-intervention Secondary Patency at 24 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|24 months||||proportion of participants||95% Confidence Interval|Number
2779050|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 24 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|24 month follow up||||proportion of participants||95% Confidence Interval|Number
2779051|NCT00677235|Secondary|To Estimate Safety at 24 Months.|To estimate the percentage of participants without safety issues through 24 months.|24 months||||percentage of participants|||Number
2779052|NCT00677235|Secondary|Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention.|Access Circuit Primary Patency (ACPP) was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.|24 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).|||proportion of participants||95% Confidence Interval|Number
2779053|NCT00677235|Secondary|Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months|Serious Adverse Events at 12 months are reported for all 270 subjects.|12 months||||percentage of participants with serious|||Number
2779054|NCT00677235|Secondary|Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure|The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the Bard Peripheral Vascular (BPV) clinician training program.|Patient Follow-Up||||events|||Number
2779055|NCT00677235|Secondary|Procedural Success|Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.|Patient Follow-Up||||Percentage of Participants|||Number
2779056|NCT00677235|Secondary|Post-intervention Secondary Patency (PSP) at 12 Months|Postintervention secondary patency [PSP; referred to as Access Circuit Cumulative Patency (ACCP) in the pivotal trial] was the interval following the treatment procedure until the access circuit was surgically declotted, revised, or abandoned because of inability to treat the original stenosis.|12 months||||proportion of participants||95% Confidence Interval|Number
2779057|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 12 Months|Postintervention assisted primary patency (PAPP) was defined as the interval after the index/study procedure until access thrombosis or a surgical intervention that excluded the treated lesion from the access circuit.|12 months||||proportion of participants||95% Confidence Interval|Number
2779058|NCT00677235|Secondary|To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure|The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|Patient Follow-Up||||reinterventions||Standard Deviation|Mean
2779059|NCT00677235|Primary|The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.||12 months||||Number of Participants with Device and/o|||Number
2779060|NCT00677235|Primary|The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.|12 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.|||Months/intervention||Standard Deviation|Least Squares Mean
2779061|NCT00677235|Primary|ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.|To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.|12 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).|||proportion of participants||95% Confidence Interval|Number
2779062|NCT00677092|Secondary|Change From Baseline in Short Form 36 (SF-36) Score||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
2779063|NCT00677092|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
2779064|NCT00677092|Secondary|Change From Baseline in Visual Analog Scale (VAS) for Pain||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
2779065|NCT00677092|Secondary|Change From Baseline in Histologic Appearance of Skin Biopsy||Baseline and Month 4|PI left institution in 2009; Data collected cannot be associated with specific participants and analyzed for secondary outcome measure.||||||
2779067|NCT00677092|Primary|Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering|The modified Rodnan Skin Score is the accepted clinical measure of scleroderma skin activity. The investigator assessed the thickening of the skin using the modified Rodnan Skin Score through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness was assessed on a scale of 0 to 3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0 (normal) to 51 (severe thickening in all 17 areas). Percentage change is calculated as the Month 4 Score - Baseline Score/Baseline Score * 100. A negative percentage change indicates improvement.|Baseline and Month 4|All enrolled participants with Baseline and Month 4 data available for analysis.|||percentage change in mRSS score||Standard Deviation|Mean
2779068|NCT00677040|Secondary|Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.||One visit||||Participants|||Count of Participants
2779069|NCT00677040|Primary|Tissue Oxygenation|Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.|One visit for 20 minutes||||mmHg||Standard Deviation|Mean
2779070|NCT00677014|Secondary|Secondary Endpoints Will Include Structural and Functional Measures||Chronic|||||||
2779071|NCT00677014|Primary|Left Ventricular End-systolic Volume (LVESV)|Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up|6 months|Availability of baseline and 6 month echocardiograms with primary endpoint values (LVESV) among randomized patients|||ml||Inter-Quartile Range|Median
2779072|NCT00676897|Secondary|Inflammatory Marker Levels|Change in inflammatory marker levels over time from time zero to time 24 hour.|over 24 hours (time zero and time 24 hours)||||pg/mL and ng/mL||Standard Deviation|Mean
2779073|NCT00676897|Primary|Time to Shock Reversal||up to 7 days||||hours||Standard Deviation|Mean
2779074|NCT00676806|Secondary|Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation|Composite endpoint of GVH or infection. Too few events to compare between arms.|+180 days||||events|||Number
2779075|NCT00676806|Secondary|Incidence of Chronic GVHD||After Day +100|No subject receiving reduced intensity conditioning was evaluable for the event of chronic GVHD (0/3 subjects survived to day +100)|||participants|||Number
2779076|NCT00676806|Secondary|Infectious Complications in UCB Recipients.||Day +100||||participants|||Number
2779077|NCT00676806|Secondary|Incidence of Acute GVHD||Day +100||||participants|||Number
2779078|NCT00676806|Secondary|Proportion of Subjects With Platelet Engraftment|Proportion of patients engrafting by days +45, +90, and +180.|+45, 90, and 180 days||||participants|||Number
2779079|NCT00676806|Primary|Number of Participants With Neutrophil Engraftment|Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning|+45 and 90 days|Only 2 subjects were evaluable from each group at the +45 day mark. The same number were evaluable at the +90 day mark.|||participants|||Number
2779080|NCT00676793|Primary|Change in Serum HGF and Breast Cancer|Change in serum HGF from baseline to post Polyphenol E treatment.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.|||pg/ml||Inter-Quartile Range|Median
2779081|NCT00676793|Primary|Change in Serum VEGF in Breast Cancer|Change in serum VEGF from baseline to post treatment with polyphenon E.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.|||pg/ml||Inter-Quartile Range|Median
2779082|NCT00676780|Primary|Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.|Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|Number of participants for analysis was determined per protocol.|||pg/mL||Inter-Quartile Range|Median
2779083|NCT00676780|Primary|Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.|Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks.|The number of participants for analysis was determined per protocol.|||pg/mL||Inter-Quartile Range|Median
2779084|NCT00676780|Primary|Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer|Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|The number of participants for analysis was determined per protocol.|||ng/mL||Inter-Quartile Range|Median
2779085|NCT00676715|Secondary|Total Number of Gadolinium-Enhancing T1 Lesions at Weeks|Total number of gadolinium-enhancing T1 lesions at weeks were reported.|Weeks 4 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.|||Lesions||Standard Deviation|Mean
2779086|NCT00676715|Secondary|Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain|Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.|Weeks 4 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.|||Lesions||Standard Deviation|Mean
2779087|NCT00676715|Secondary|Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24|Change from baseline in total volume of T2 lesions on MRI scans of the Brain at week 24 was reported.|Baseline, Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, n signifies the number of participants evaluated at specified time points.|||Cubic Millimeter (mm^3)||Standard Deviation|Mean
2779088|NCT00676715|Secondary|Percentage of Participants Who Remained Relapse Free at Week 24|Percentage of participants who remained relapse free at week 24 were reported.|Week 24|The intent-to-treat population includes all randomized participants who had received any study drug.|||percentage of participants||95% Confidence Interval|Number
2779089|NCT00676715|Secondary|Annualized Protocol Defined Relapse Rate at Week 24|Adjusted annualized relapse rate for geographical region.|Week 24|The intent-to-treat population includes all randomized participants who had received any study drug.|||Number of relapses||95% Confidence Interval|Number
2779434|NCT00674128|Primary|Reported Here Are the Number of Participants With Devices That Developed Infection||Within 3 months after surgery.||||participants|||Number
2779090|NCT00676715|Primary|Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain|Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.|Week 12 to Week 24|The intent-to-treat population includes all randomized participants who had received any study drug. Here, number of participants analysed signifies the participants who were evaluable for the outcome.|||Lesion||Standard Deviation|Mean
2779091|NCT00676689|Secondary|Functional Improvement|"Functional improvement at 6 months as defined by:~a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis."|6 months|Valve implant population. There were 2 screen failure patients and 10 patients where procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population. There were 11 additional patients for which data was not available for analysis, leaving 58 patients in this analysis.|||participants|||Number
2779092|NCT00676689|Secondary|Freedom From MACCE|Clinical Events Committee (CEC) adjudicated.|6 Months|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.|||percentage of participants||95% Confidence Interval|Number
2779093|NCT00676689|Primary|Freedom From Device or Procedure Related Death or Reintervention||1 year|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.|||percentage of participants||95% Confidence Interval|Number
2779094|NCT00676676|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Scale|the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).|Baseline, 2-week, 8-week|This was a pilot protocol|||units on a scale||Standard Deviation|Mean
2779095|NCT00676663|Other Pre-specified|Overall Survival (OS)|OS was defined as the number of months elapsed between the date of randomization and the date of death (whatever the cause).|First dose of study drug to end of study (Median follow-up 24 months in the EE arm and 26.4 months in the EP arm)|Full Analysis Set included all randomized participants.|||months||95% Confidence Interval|Median
2779096|NCT00676663|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|"An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Worsening of a pre-existing medical condition was considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. Abnormal clinical laboratory findings determined by the investigator to be clinically significant were recorded as AEs. A TEAE is an AE that starts after the administration of study drug.~A SAE is any AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth effect or other significant medical hazard."|First dose to within 30 days of last dose of study drug (Up to Approximately 2 Years)|Safety Population included all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2779097|NCT00676663|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the percentage of participants with overall response (CR + PR) plus stable disease (SD) for 6 months as assessed by the investigator based on RECIST, version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From date of randomization to discontinuation due to disease progression or intolerable AE up to primary completion date (Median follow-up 6 months)|Full Analysis Set included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2779098|NCT00676663|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of participants with response during treatment classified as complete response (CR) or partial response (PR), as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|From date of randomization to discontinuation due to disease progression or intolerable Adverse Event (AE) up to primary completion date (Median follow-up 6 months)|Full Analysis Set included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2779099|NCT00676663|Primary|Progression-free Survival (PFS)|PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.|From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)|Full Analysis Set included all randomized participants.|||months||95% Confidence Interval|Median
2779100|NCT00676650|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction."|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early||||||
2779121|NCT00676520|Secondary|Dual Antiplatelet Therapy Non-compliance Through 1 Year|Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.|1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
2784955|NCT00630539|Secondary|Visual Evaluation of Vagina (by Gynecological Examination)||Screening & Week 12|ITT|||percentage of subjects|||Number
2779101|NCT00676650|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early||||||
2779102|NCT00676650|Secondary|Change From Baseline in Pain Severity|Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.|Day 1 through Day 7 every 28 days (every cycle) up to 29 months|Data not summarized, study terminated early||||||
2779103|NCT00676650|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response|Baseline, every 8 weeks up to 123 weeks|Data not summarized, study terminated early||||||
2779104|NCT00676650|Secondary|Percent of Participants With Objective Response (OR)|OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.|Baseline, every 8 weeks up to 123 weeks|FA Population|||percentage of participants||95% Confidence Interval|Number
2779105|NCT00676650|Secondary|Progression-Free Survival (PFS)|PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02|Baseline, every 8 weeks up to 123 weeks|FA Population|||weeks||95% Confidence Interval|Median
2779106|NCT00676650|Primary|Overall Survival (OS)|OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.|Baseline up to 32 months|Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.|||months||95% Confidence Interval|Median
2779107|NCT00676585|Secondary|Sub-group Analysis of Patients With Adrenal Insufficiency|Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL|At time of enrollment|There were 9 patients identified with baseline absolute cortisol deficiency (3 in the control arm and 6 in the intervention arm). This sub population of study participants were analyzed for shock reversal, good neurological outcomes, and survival as shown in each row of the table below.|||Participants|||Count of Participants
2779108|NCT00676585|Secondary|Mortality||Length of hospital stay, an average of 9 days with a maximum of 36 days||||Participants|||Count of Participants
2779109|NCT00676585|Primary|Time to Shock Reversal|The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications.|7 Days||||hours||Inter-Quartile Range|Median
2779110|NCT00676572|Secondary|Differences in the Effect of p38 MAPK Inhibitor in Dexamethasone−Inhibition of Cytokine Release From Alveolar Macrophages and PBMCs Between Severe and Non−Severe Asthmatics|Percentage of Suppression of IL6 release by p38 MAPK inhibitor|3 years||||percentage of suppression of IL6 release||Standard Error|Mean
2779111|NCT00676572|Primary|Differences in Activity and Downstream Activity of the p38 MAPK Activity in Macrophages or PBMCs Between Those From Severe and Non−Severe Asthmatics||3 years|Data no collected||||||
2779112|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
2779113|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
2779114|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
2779115|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
2779116|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
2779117|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||units on the SAQ scale||Standard Deviation|Mean
2779118|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779119|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779120|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779547|NCT00673309|Secondary|Improved Rate of Wound Healing|Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.|Admission to burn unit to 95% wound healing|||||||
2779122|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
2779123|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 180 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
2779124|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 30 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
2779125|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 14 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants|||Number
2779126|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779127|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779128|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779129|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 14 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779130|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779131|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779132|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779133|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2797688|NCT00538642|Secondary|Abdominal Circumference||Baseline||||cm||Standard Deviation|Mean
2779134|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779135|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779136|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779137|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779138|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779139|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779140|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779141|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779142|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779143|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779144|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779145|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779146|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2780297|NCT00667251|Secondary|Time to CNS Metastases at the Time of First Progression||From randomization to CNS metastases at time of first progression, assessed up to 39 months.||||Months||Full Range|Median
2779147|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779148|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779149|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779150|NCT00676520|Secondary|Procedural Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of participants||95% Confidence Interval|Number
2779151|NCT00676520|Secondary|Clinical Device Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.|||percentage of lesions|Participants|95% Confidence Interval|Number
2779152|NCT00676520|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)|MI= ARC (Academic Research Constortium) defined|1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779153|NCT00676520|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).|"ARC Defines Stent Thrombosis in the following way:~Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria:~Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers~Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause~Possible Stent Thrombosis Any unexplained death beyond 30 days~For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1"|up to 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|||percentage of participants||95% Confidence Interval|Number
2779154|NCT00676494|Primary|Major Adverse Events (MAEs) Within 30 Days|Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.|30 days|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||Participants|||Number
2779155|NCT00676494|Secondary|Freedom From Target Lesion Revascularization (TLR) at 6 Months|Number of patients that did not require target lesion revascularization 6 months after index procedure.|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||participants|||Number
2779156|NCT00676494|Secondary|Average Ankle Brachial Index (ABI) at 6 Months|Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||units on scale||Standard Deviation|Mean
2779157|NCT00676494|Secondary|Average Rutherford Classification Score at 6 Months|Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.|||Score on scale||Standard Deviation|Mean
2779158|NCT00676455|Secondary|Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.|"Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan.~Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.||||||
2797689|NCT00538642|Secondary|Body Mass Index||4-5 months||||Kg/m2||Standard Deviation|Mean
2779159|NCT00676455|Primary|This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions|"Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis.~Due to lack of participants. No significant findings are reported at this time."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.||||||
2779160|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores|"Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment."|Baseline, Week 6|ITT; N = number of subjects in a treatment group.|||participants|||Number
2779161|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values.|||scores on scale||Standard Error|Least Squares Mean
2779162|NCT00676403|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6|RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values.|||scores on scales||Standard Error|Least Squares Mean
2779163|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.|Week 1, Week 2, Week 4, Week 6|ITT|||participants|||Number
2779164|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779165|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779166|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779167|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779168|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2780634|NCT00665626|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC values less than 1500/mm3|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2779169|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779170|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779171|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779172|NCT00676403|Secondary|Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||scores on scale||Standard Error|Least Squares Mean
2779173|NCT00676403|Secondary|Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.|||minutes||Standard Error|Least Squares Mean
2779174|NCT00676403|Secondary|Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.|||awakenings||Standard Error|Least Squares Mean
2779175|NCT00676403|Secondary|Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.|||hours||Standard Error|Least Squares Mean
2779176|NCT00676403|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.|||minutes||Standard Error|Least Squares Mean
2779177|NCT00676403|Secondary|Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)|CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)|ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.|||participants|||Number
2779189|NCT00676338|Secondary|Change in Body Weight From Baseline to Week 26|Change in Body Weight from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||kg||Standard Error|Least Squares Mean
2779178|NCT00676403|Secondary|Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|Week 6|ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.|||participants|||Number
2779179|NCT00676403|Primary|Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6|IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.|||scores on scale||Standard Error|Least Squares Mean
2779180|NCT00676364|Primary|Pain From Venipuncture|"Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. FACES in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain."|Pain was measured immediately after venipuncture.|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|||scores on a scale||Standard Deviation|Mean
2779181|NCT00676364|Secondary|Anxiety of Venipuncture|Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.|During venipuncture|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|||scores on a scale||Standard Deviation|Mean
2779182|NCT00676338|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in Diastolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmHg||Standard Error|Least Squares Mean
2779183|NCT00676338|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26.|Change in Systolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmHg||Standard Error|Least Squares Mean
2779184|NCT00676338|Secondary|Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events|Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.|||events per subject-year||Standard Error|Mean
2779185|NCT00676338|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.|||events per subject-year||Standard Error|Mean
2779186|NCT00676338|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
2779187|NCT00676338|Secondary|Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in Fasting HDL from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmol/L||Standard Error|Least Squares Mean
2779188|NCT00676338|Secondary|Change in Fasting Total Cholesterol (TC) From Baseline to Week 26|Change in Fasting TC from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmol/L||Standard Error|Least Squares Mean
2779190|NCT00676338|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.|||mmol/L||Standard Error|Least Squares Mean
2779191|NCT00676338|Primary|Percentage of Patients Achieving HbA1c <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).|Baseline, Week 26|ITT subjects with baseline HbA1c>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||percentage of patients|||Number
2779192|NCT00676338|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|Intent to treat (ITT) population consisted of all randomized patients who had taken at least one dose of study drug. All scheduled post-baseline measurements were included in the analysis. Unscheduled visit observations were carried forward to the next scheduled visits.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2779193|NCT00676208|Secondary|Change in Professionals' Attitudes About Diabetes|The University of Michigan's Research and Training Center's Diabetes Attitude Scale was used. There are 33 items and the response format is a 5 point Likert Scale ranging from 'strongly disagree'(1) to 'strongly agree'(5). A higher score means more positive attitudes toward diabetes and its treatment (e.g., psychosocial impact of diabetes; value of tight glucose control).The total score is computed by summing individual items and ranges from 0 to 165. Post-pre total scores were used with positive and higher values indicating greater favorable change.|Pre-intervention and Post-intervention at 1 month||||units on a scale||Standard Deviation|Mean
2779194|NCT00676208|Primary|Change in Confidence in Ability to Perform Teamwork|A three item scale was used to assess confidence in ability to convey logic of recommendations to other providers, explain one's distinctive perspective, and be accountable to patients for a decision made by a colleague from another discipline. The responses for each item ranged from 'not at all confident' (0) to 'very confident' (4), with higher values indicating more confidence. The total scale ranged from 0 to 16 with higher being more confident. Difference scores were analyzed (post-pre) with positive and higher values indicating more favorable change.|Pre-intervention and Post-Intervention at 1 month||||units of a scale||Standard Deviation|Mean
2779195|NCT00676195|Secondary|Glutathione Metabolism Intermediates in Peripheral Blood Measured by High-performance Liquid Chromatography||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
2779196|NCT00676195|Secondary|Irritability Subscale of the Aberrant Behavior Checklist (ABC)||4, 8, and 12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
2779197|NCT00676195|Secondary|Sensory Profile Questionnaire (SPQ)||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
2779198|NCT00676195|Secondary|Social Responsiveness Scale (SRS)||12 weeks|No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.||||||
2779199|NCT00676195|Primary|Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)|Number of Participants with adverse events reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) during the course of the study as measured at time points (4, 8, and 12 weeks).|4, 8, and 12 weeks||||number of participants|||Number
2779200|NCT00676182|Primary|Beck Depression Inventory Score (Total Score)|Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
2779201|NCT00676182|Primary|Alcohol Use Disorders Identification Test (AUDIT) (Total Score)|Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
2779202|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Severity|Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
2779203|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)|Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.|||units on a scale||Standard Deviation|Mean
2779204|NCT00676182|Primary|PTSD Checklist Military Form (PCL-M) (Total Score)|Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.|Baseline, 6 Months, 12 Months|Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.|||units on a scale||Standard Deviation|Mean
2779205|NCT00676182|Primary|Patient Competency Rating Scale (PCRS) (Total Score)|Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)|Baseline, 6 Months, 12 Months|Only participants with data at the specified time were analyzed.|||units on a scale||Standard Deviation|Mean
2779206|NCT00676182|Primary|Craig Handicap Assessment and Reporting Technique (CHART)|"Ranges for Subscales: 0 - 100 Physical Independence: 4 -100 Cognitive Independence: 0 -100 Mobility: 0 -100 Occupation: 0 -100 Social Integration: 0 -100 Economic Self Sufficiency: 0-100~Directionality: for each subscale, higher score means more independence; lower score means needs more assistance."|Baseline, 6 Months, 12 Months|Only participants with data at the specified time points were analyzed.|||units on a scale||Standard Deviation|Mean
2779208|NCT00676143|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
2779209|NCT00676143|Secondary|Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participant|||Number
2779210|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)|"Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining deterioration for Alzheimer's disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit."|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants||95% Confidence Interval|Number
2779211|NCT00676143|Secondary|Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score was <7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participant|||Number
2779212|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)|"Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining deterioration for Alzheimer's disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit."|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants||95% Confidence Interval|Number
2779213|NCT00676143|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Unit on a scale||Standard Error|Least Squares Mean
2779214|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening) from baseline in DAD total score of >=12.|Baseline and 78 Weeks||||Days||95% Confidence Interval|Median
2779215|NCT00676143|Secondary|Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)|The time to first median placebo deterioration was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
2779216|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
2779270|NCT00675792|Secondary|Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide|Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine|||participants|||Number
2797690|NCT00538642|Secondary|Body Mass Index||Baseline||||Kg/m2||Standard Deviation|Mean
2779217|NCT00676143|Secondary|Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of median time to first median placebo deterioration was presented.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
2779218|NCT00676143|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Year||Standard Error|Least Squares Mean
2779219|NCT00676143|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Year||Standard Error|Least Squares Mean
2779220|NCT00676143|Secondary|Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71|Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|Baseline and 71 Weeks|vMRI population included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.|||Milliliter (mL)/year||Standard Error|Least Squares Mean
2779221|NCT00676143|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71|Biomarkers CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|Baseline and 71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).|||pg/mL||Standard Error|Least Squares Mean
2779222|NCT00676143|Secondary|Change From Baseline in Brain Amyloid Burden at Week 71|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PIB) positron emission tomography (PET). The latter is a semi-quantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|Baseline and 71 weeks|PIB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one postbaseline PIB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI ≥1.35 at baseline.|||standard uptake value ratio||Standard Error|Least Squares Mean
2779223|NCT00676143|Primary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78|"The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant.~This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement."|Baseline and 78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Unit on a scale||Standard Deviation|Least Squares Mean
2784956|NCT00630539|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT|||pH||Standard Deviation|Mean
2779224|NCT00676143|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78|"The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.~This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced.~The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment."|Baseline and 78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.|||Unit on a scale||Standard Error|Least Squares Mean
2779225|NCT00676130|Secondary|Progression to Abscess|Proportion of subjects in each arm with progression from cellulitis to abscess.|12 +/- 2 days, 30 days +/- 2 days||||participants|||Number
2779226|NCT00676130|Primary|Relative Efficacy|"Proportion of subjects in each arm with successful treatment.~Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days."|12 +/- 2 days; 30 +/- 2 days|Of the 153 randomized subjects, 4 were randomized in error and did not receive study drug, 1 received two doses before it was discovered that he was ineligible, 1 was lost to follow up, and 1 withdrew voluntarily in the first few days after enrollment. This left 146 subjects for intent-to-treat analysis.|||participants|||Number
2779227|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779228|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779229|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779230|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779231|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779232|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779233|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2786333|NCT00619918|Primary|Length of Stay|Length of stay defined as date of discharge minute date of admission.|1 month||||Days||Standard Deviation|Mean
2779234|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2779235|NCT00676091|Secondary|Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
2779236|NCT00676091|Secondary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2779237|NCT00676091|Primary|Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
2779238|NCT00676091|Primary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2779239|NCT00676065|Primary|Breast Cancer|Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
2779240|NCT00676065|Primary|Venous Thromboembolism|Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
2779241|NCT00676065|Primary|Arterial Thromboembolism|Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
2779242|NCT00676052|Secondary|Change From Baseline in Clinic Visit Trough FVC on Day 29|The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.|Baseline (pre-dose Day 1) and Day 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.|||Liter||Standard Error|Least Squares Mean
2779243|NCT00676052|Secondary|Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29|Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.|Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.|||Liter||Standard Error|Least Squares Mean
2779449|NCT00673881|Secondary|Change in Neutral Sterol Excretion|The excretion rate of fecal neutral and acidic sterols was measured as mg/day, for each individual three times during the 10 day period following the isotope infusions at baseline and end-of-treatment.|baseline to 12 weeks|||||||
2779244|NCT00676052|Secondary|Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29|Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.|Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29|ITT Population. Participants with analyzable data on the indicated time point have been presented.|||Liter||Standard Error|Least Squares Mean
2779245|NCT00676052|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.|Baseline (pre-dose Day 1) and Day 29|ITT Population. Last observation carried forward (LOCF) data has been presented.|||Liter||Standard Error|Least Squares Mean
2779246|NCT00676026|Primary|To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.|Each medication will be administered 2 times during a 1-month menstrual cycle.|UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.||||||
2779247|NCT00676013|Primary|Burn Scar Comparison|Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.|2 years post burn injury|Each site grafted with a skin substitute was analyzed with a Scar Assessment|||units on a scale||Standard Deviation|Mean
2779248|NCT00675987|Secondary|Change in E-selectin|E-selectin is expressed on inflamed endothelial cells in response to treatment with inflammatory cytokines.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||ng/ml||95% Confidence Interval|Mean
2779249|NCT00675987|Secondary|Change in F2-isoprostanes|F2-isoprostanes is a marker of oxidative stress.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||ng/mg of creatinine||95% Confidence Interval|Mean
2779250|NCT00675987|Secondary|Change in Ox-LDL (Oxidized Low-density Lipoprotein)|ox-LDL measures protein damage due to the oxidative modification of the ApoB subunit on LDL cholesterol.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||units/l||95% Confidence Interval|Mean
2779251|NCT00675987|Secondary|Change in MCP-1 (Monocyte Chemoattractant Protein-1)|MCP-1 is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||pg/ml||95% Confidence Interval|Mean
2779252|NCT00675987|Secondary|Change in VCAM-1(Vascular Cell-adhesion Molecule-1)|VCAM-1 is an immunoglobulin-like adhesion molecule expressed on activated endothelial cells.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||ng/ml||95% Confidence Interval|Mean
2779253|NCT00675987|Secondary|Change in hsCRP (High-sensitivity C-reactive Protein)|hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||percentage change||95% Confidence Interval|Mean
2779254|NCT00675987|Secondary|Change in Urine Albumin/Creatine|Urine was obtained to assess for the presence of microalbuminuria.|baseline, 8 weeks|27 participants were randomized to placebo, and 26 participants were randomized to Losartan, but 1 placebo participant and 1 Losartan participant did not complete the study.|||mg/mmol||95% Confidence Interval|Mean
2779255|NCT00675987|Primary|Insulin Sensitivity Utilizing Endothelial Function as Assessed by Pulse Volume Amplitude|Endothelial function assessed as the ratio of pulse volume amplitude after compared with before a reactive hyperemia stimulus, measured by peripheral (fingertip) arterial tonometry. Reported values indicate the percentage change from Baseline in the ratio of pulse volume amplitude after compared to before the reactive hyperemia stimulus.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were excluded)|||percentage change||Standard Deviation|Mean
2779256|NCT00675987|Primary|Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp|Insulin clamp derived insulin sensitivity, as insulin stimulated glucose disposal corrected for steady state insulin level.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were excluded)|||mg/kg/min||Standard Deviation|Mean
2779469|NCT00673712|Primary|Hospital Acquired Pneumonia|Pneumonia diagnosed during hospitalization|30 days postoperative|all randomized subjects|||participants|||Number
2808964|NCT00459368|Secondary|Asthma-related Emergency Room Visits||1 year|||||||
2779257|NCT00675948|Secondary|Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment|The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all randomised subjects who received at least one dose of study medication and who yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
2779258|NCT00675948|Secondary|Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all subjects who entered the study, who were randomised, who received at least one dose of study medication and who yielded on-treatment efficacy data|||units on a scale||Standard Deviation|Mean
2779259|NCT00675948|Primary|The Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event in this study is presented.|0 - 657 days|All subjects who took at least one dose of study medication and yielded on-treatment efficacy data were classed as the safety population.|||participants|||Number
2779260|NCT00675922|Secondary|Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients||Admission to burn unit to discharge|||||||
2779261|NCT00675922|Primary|Infection Rate|Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.|Acute hospitalization following burn injury: admission to discharge (1-20 weeks)|Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections|||percentage of participants|||Number
2779262|NCT00675909|Secondary|Nurse Rating of Sedation|Range is 0-10. Higher is associated with nurse impression that sedation is better.|After the procedure nurse was asked about their impression of the level of sedation.||||units on a scale||Full Range|Median
2779263|NCT00675909|Secondary|Physician Rating of Sedation|Range is 0-10. Higher is associated with physician impression that sedation is better.|Physician was asked after the procedure was done about their impression of sedation.||||units on a scale||Full Range|Median
2779264|NCT00675909|Secondary|Duration of Procedure||Duration of procedure up to 40 minutes||||minutes||Full Range|Median
2779265|NCT00675909|Secondary|Time From Study Drug Administration to Start of Procedure||Time from study drug administration to start of procedure up to 68 minutes||||minutes||Full Range|Median
2779266|NCT00675909|Primary|Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).|"Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation.~Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3)."|Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).|Intention to treat|||Scores on a scale||95% Confidence Interval|Median
2779267|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||Minutes||Standard Deviation|Mean
2779268|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||Minutes||Standard Deviation|Mean
2779269|NCT00675792|Secondary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||Minutes||Standard Deviation|Mean
2779271|NCT00675792|Secondary|Number of Participants With Post-operative Complications|Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine|||participants|||Number
2779272|NCT00675792|Primary|Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation|Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed.|Up to the first 24 hours after tracheal extubation|Intent to treat (ITT) group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.|||T4/T1 Ratio||Standard Deviation|Mean
2779273|NCT00675766|Primary|Neuropsychological Status (i.e., Cognitive Functioning)|Neurocognitive functions refer to cognitive abilities, namely learning/memory, motor speed, psychomotor speed, language, attention, visuospatial abilities, & executive function. They are measured using standard clinical neuropsychological test battery that included: HVLT, BVMT-R, Trails A & B, WCST-64, WAIS-Symbol Search/Digit Coding/Letter-Number Sequencing/Block Design, FAS, & Animals. Subgroups of these tasks were combined to create composite scores indicating participants' score on each cognitive domains. To make these cognitive domain composite scores, each participant's raw score on each of these tests was converted into a within-sample standardized score (i.e., z-score), which are normally distributed with a mean of 0 & SD of 1. Then, these standardized scores were summed to create composite scores for each cognitive domain and then averaged to create a global neuropsychological function composite score. A positive composite score represents a better outcome for all variables.|Baseline (Year 1) and 1-year follow-up (Year 2)|HIV+ and HIV negative men who were evaluated BOTH at baseline and Year 2. Those participants who were evaluated at Baseline but not at Year 2 were excluded from analyses.|||z-score composites of cognitive domains||Standard Error|Mean
2779274|NCT00675597|Primary|To Measure the Number of Cycles|Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.|2 years||||participants|||Number
2779275|NCT00675584|Secondary|Change Between 12 Months and Baseline in the Caregiver Quality-of-life|The caregiver quality-of-life questionnaire consists of seven questions, each scored from 0 (worse) to 3 (best), and all seven questions are summed to yield a total score ranging from 0 to 21|baseline and 12 months|Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the analysis based on the linear mixed-effects model|||units on a scale||95% Confidence Interval|Least Squares Mean
2779276|NCT00675584|Secondary|Change in Wheeze Severity During a Respiratory Tract Illness|Wheeze severity is scored as 0 (none) to 5 (very severe) during a respiratory tract illness|Measured during the first seven days for each respiratory tract illness|The data from every respiratory tract illness is included in the analysis|||units on a scale||95% Confidence Interval|Mean
2779277|NCT00675584|Secondary|Proportion of Days With Rescue Albuterol Use||Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days|||proportion of days||95% Confidence Interval|Mean
2779278|NCT00675584|Secondary|Number of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 Months||Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days|||days per 12 months||95% Confidence Interval|Mean
2779279|NCT00675584|Secondary|Adverse Events Associated With Corticosteroid Use||Measured during the 12-month follow-up period|All randomized children are included|||Participants|||Count of Participants
2779280|NCT00675584|Secondary|Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry||baseline and 12 months|Prior to enrollment of the first randomized study participant, the clinical investigators decided that it would be futile to perform oscillometry in children of the target age range for MIST (2-5 years of age). A previous CARE Network trial (PEAK) performed oscillometry in such children, but the data were highly variable and of poor quality.||||||
2779281|NCT00675584|Secondary|Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO)|Exhaled nitric oxide (eNO) is measured in parts per billion, and the change constructed between 12 months and baseline|baseline and 12 months|Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the analysis based on the linear mixed-effects model|||parts per billion||95% Confidence Interval|Least Squares Mean
2779282|NCT00675584|Secondary|Number of Participants With Treatment Failure|"Treatment failure was defined as the occurrence of at least one of the following events:~four courses of systemic corticosteroids~one hospitalization for acute exacerbation of wheezing~hypoxic seizure during an acute exacerbation of asthma/wheezing~intubation for acute asthma/wheezing~serious adverse event related to a study medication~physician discretion with specific rationale"|Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the assessment of treatment failure|||Participants|||Count of Participants
2779283|NCT00675584|Secondary|Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months||Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of urgent care visits|||visits per 12 months||95% Confidence Interval|Mean
2779284|NCT00675584|Secondary|Proportion of Episode-free Days|An episode-free day consisted of no asthma symptoms and no asthma rescue medications|Measured during the 12-month follow-up period|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numerator and denominator of the proportion of episode-free days|||proportion of episode-free days||95% Confidence Interval|Mean
2809825|NCT00453206|Secondary|Iron Status at the Time of Transplantation||baseline|||||||
2779289|NCT00675506|Secondary|Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS|Change in post-exercise phosphocreatine recovery [ViPCr] between baseline and 12 months (positive change indicates increase in the variable between baseline and 12 months). ViPCR is the initial rate of phosphocreatine recovery normalized based on participant effort. Greater ViPCr represents relatively better mitochondrial function.|Measured at Baseline and Month 12|All available data. Assessment of mitochondrial function could not be performed in all patients.|||milliMoles/second||Standard Deviation|Mean
2779290|NCT00675506|Secondary|Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone|Overnight frequent sampling of growth hormone levels was performed and characteristics of pulsatile secretion were determine using automated deconvolution (using AutoDecon software). Based on the deconvolution, the median pulse mass (in nanograms per millileter of growth hormone) was calculated. A positive number indicates an increase in median pulse mass between baseline and 12 months.|Measured at baseline and Month 12|All available data (all participants for whom change from baseline to 12 months was available)|||nanograms/milliliter||Standard Deviation|Mean
2779291|NCT00675506|Secondary|Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test|Glucose tolerance was determined after an overnight fast using standard 75 gram oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Change in glucose tolerance (fasting and 2 hour OGTT) between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||mg/dL||Standard Error|Mean
2779292|NCT00675506|Secondary|Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)|Lipid Profile (total cholesterol, high-density lipoproteins [HDL] cholesterol, low-density lipoproteins [LDL] cholesterol, triglycerides)was determined after an overnight fast. The change in lipid profile between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||mg/dL||Standard Error|Mean
2779293|NCT00675506|Secondary|Change in Carotid Intima-media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||mm||Standard Error|Mean
2779294|NCT00675506|Primary|Change in Visceral Adipose Tissue Volume|Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.|||cm2||Standard Error|Mean
2779295|NCT00675441|Primary|Number of Participants' With Treatment Response of Complete or Partial Response|Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.|Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.|Of the five (5) participants enrolled, two participants were taken off study after only a few days of therapy and one participant expired, all three of which were not evaluable for response.|||participants|||Number
2779296|NCT00675428|Secondary|Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)||Cycle 1: Day 1 (1 hour before infusion and 1 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: 1 hour before and 1 hour after infusion). Cycle 6: Day 1 (1 hour before infusion and 1 hour after infusion), Days 8, 15, 22.|Analysis of binding saturation of α4 integrin sites was not performed because the study was terminated early.||||||
2779297|NCT00675428|Secondary|Pharmacokinetic (PK) Profile Of Natalizumab|PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).|Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)|PK analysis was not performed because the study was terminated early.||||||
2779298|NCT00675428|Secondary|Kaplan-Meier Estimates for Duration Of Response For Participants With A Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Kaplan-Meier methods were used to estimate the median duration of response and associated 95% confidence intervals.|Day 1 up to Month 6|Duration of response was not calculated because the study was terminated early.||||||
2779299|NCT00675428|Secondary|Number Of Participants Who Achieve A Complete Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of > 4:1 or < 1:2 performed on a minimum of 100 plasma cells.|Day 1 up to Month 6||||participants|||Number
2779300|NCT00675428|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.|Day 1 up to Month 6||||participants|||Number
2779301|NCT00675428|Primary|Objective Response Rate (ORR)|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006).|Day 1 up to Month 6|ORR was not calculated because the study was terminated early.||||||
2779302|NCT00675428|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) >3*upper limit of normal (ULN) with either a total bilirubin >2*ULN or an international normalized ratio (INR) >1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.|Day 1 up to Day 28||||participants|||Number
2779303|NCT00675415|Secondary|Proportion of Participants Experiencing Apnea||Continuously measured during endoscopy, typically about 2 hours||||Participants|||Count of Participants
2779304|NCT00675415|Secondary|Proportion of Participants Experiencing Severe Hypoxemia||Continuously measured during endoscopy, typically about 2 hours||||Participants|||Count of Participants
2779305|NCT00675415|Secondary|Proportion of Participants Requiring Supplemental Oxygen||Continuously measured during endoscopy, typically about 2 hours||||Participants|||Count of Participants
2779306|NCT00675415|Primary|Number of Participants Experiencing Hypoxemia During Endoscopy|Hypoxemia was defined as oxygen saturation less than 90 percent for at least 15 seconds.|Continuously Assessed during a single endoscopic procedure, typically about 2 hours||||Participants|||Count of Participants
2779307|NCT00675259|Secondary|Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry|LZTS1 expression in breast cancer cells collected prior to NCT|prior to surgery|LZTS1 expression in breast cancer cells collected prior to NCT was assessed in 27 patients who had evaluable core biopsies.|||patients|||Number
2779308|NCT00675259|Secondary|Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy|Relative angiogenic volume (AV) was defined as the ratio of AV to the geometric volume of the tumor in the breast.|after 2 cycles of therapy|Data only available for 20 of the 28 evaluable patients|||ratio||Standard Deviation|Mean
2779309|NCT00675259|Primary|Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0|Up to 4 weeks|all grade 3 adverse events|||patients|||Number
2779310|NCT00675259|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|every 4 weeks|Includes patients with triple negative breast cancer and ER+/PR+ breast cancer.|||patients|||Number
2779311|NCT00675103|Secondary|Mean Plasma Uric Acid|This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.|Baseline, Week 3 and Week 7|ITT population|||mg/dL||Standard Deviation|Mean
2779312|NCT00675103|Primary|Adverse Event Profile|Number of participants reporting events|6 months||||Number of participants|||Number
2779313|NCT00674986|Secondary|Glycemic Variability Pre and Post-Prandial Excursions at Each Meal|"Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion.~The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects."|Month 1, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||mg/dL||Standard Error|Least Squares Mean
2779314|NCT00674986|Secondary|Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day|SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.|12 Months|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Tests/day||Standard Error|Least Squares Mean
2779315|NCT00674986|Secondary|Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)|Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Per protocol population included all enrolled participants who completed the baseline training visit, completed at least 4 of 5 clinical visits, and had evaluable HbA1c data at Month 12. The Structured Testing Group also had to have at least 80% of the blood glucose values.|||Score on a scale||Standard Error|Least Squares Mean
2779316|NCT00674986|Secondary|Change From Baseline in the World Health Organization (WHO-5) Well-being Index|Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Score on a scale||Standard Error|Least Squares Mean
2809826|NCT00453206|Secondary|Graft-versus-host Disease||monthly|||||||
2779317|NCT00674986|Secondary|Change From Baseline in the Diabetes Distress Scale (DDS)|Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Score on a scale||Standard Error|Least Squares Mean
2779318|NCT00674986|Secondary|Change From Baseline in Depression Severity (PHQ-8)|The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Score on a scale||Standard Error|Least Squares Mean
2779319|NCT00674986|Secondary|Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations|Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)|12 Months|Intent to treat population included all enrolled participants who completed the Baseline training visit. Participants who dropped out before Month 1 visit were not included in the analysis.|||Visits||Standard Deviation|Mean
2779320|NCT00674986|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12|Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.|||Percent||Standard Error|Least Squares Mean
2779321|NCT00674973|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Up to 28 days after discontinuation of study drug (up to 30 months)|Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population.|||participants|||Number
2779322|NCT00674973|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.|From the time of randomization until or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||months||95% Confidence Interval|Median
2779323|NCT00674973|Secondary|Percentage of Participants With Disease Control Rate (DCR)|Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
2779324|NCT00674973|Secondary|Percentage of Participants With Best Overall Response Rate|Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|From the time of randomization until progression of disease or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
2779325|NCT00674973|Primary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.|From the time of randomization until progression of disease or death (up to 30 months)|The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.|||weeks||95% Confidence Interval|Median
2779326|NCT00674817|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Tlast is the time to last quantifiable plasma concentration of GSK961081 over period determined directly from the concentration-time data|Up to 82 days|PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentration. Data is presented for the participants available at the time of assessment.|||hours||Full Range|Median
2779327|NCT00674817|Secondary|Time to Maximum Plasma Concentration (Tmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Tmax is the time to maximum plasma concentration of GSK961081 over period determined directly from the concentration-time data|Up to 82 days|PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations. Data is presented for the participants available at the time of assessment.|||Hours||Full Range|Median
2779470|NCT00673673|Secondary|Overall Survival||Upon completion of study, up to 3 years||||months||95% Confidence Interval|Median
2779328|NCT00674817|Secondary|Maximum Plasma Concentration (Cmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data|Cmax is the Maximum observed concentration of GSK961081 determined directly from the concentration-time data. A large proportion of Cmax values were reported as not countable (NC ) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. Cmax was imputed with 1/2 lowest limit of quantification (LLQ), where LLQ was 25 picograms per milliliter (pg/mL).|Up to 82 days|PK population. All participants were present for analysis, however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2779329|NCT00674817|Secondary|Area Under Plasma Concentration Time Curve (AUC) of GSK961081 to the Last Quantifiable Concentration|AUC(0-t) is the area under plasma concentration time curve of GSK961081 to the last quantifiable concentration. This parameter was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. A large proportion of AUC(0-t) and Cmax values were reported as not countable (NC) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. AUC(0-t) imputed with 1/2 lowest observed AUC(0-t), where lowest AUC(0-t) was 56.46 hour picograms per milliliter (h*pg/mL).|Up to 82 days|Pharmacokinetic (PK) population included participants in the ‘All Subjects’ population for whom a PK sample was obtained and analyzed following GSK961081 dosing. All participants were available at the time of analysis; however, for few participants, parameter cannot be derived because of non-quantifiable concentrations.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2779330|NCT00674817|Secondary|Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position|Analysis of QT (B) or QTc (F) interval during ECG (taken in supine position) was performed using Bazett's method and Fridericia's method, respectively. Heart rate, BP, potassium, and glucose were measured in supine body position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population. n=data is presented for the participants available at the time of assessment.|||hours||Full Range|Median
2779331|NCT00674817|Secondary|Minimum Change From Baseline (Pre-dose on Day 1) in Potassium Over 4 and 27 Hours and Weighted Mean Change From Baseline in Potassium Over 4 Hours|Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in potassium (K) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
2779332|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Glucose Over 4 and 27 Hours and Weighted Mean Change From Baseline in Glucose Over 4 Hours|Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in glucose (GLU) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
2779333|NCT00674817|Secondary|Minimum Change From Baseline (Pre-dose on Day 1) in Supine Diastolic Blood Pressure (DBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine DBP Over 4 Hours|Diastolic blood pressure (DBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/(MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data .|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Error|Least Squares Mean
2779334|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Supine Systolic Blood Pressure (SBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine SBP Over 4 Hours|Systolic blood pressure (SBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/ (MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data.|0-4h and 0-27h for maximum change and 0-4 h for weighted mean change|Modified Per Protocol population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Error|Least Squares Mean
2779335|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate in Supine Position From 0 to 4 Hours|Heart rate was recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population. Data is presented for the participants available at the time of assessment.|||Beats per minute||Standard Error|Least Squares Mean
2779336|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in Supine Heart Rate From 0 to 4 Hours and From 0 to 27 Hours.|Heart rate was measured in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h) and until 27 hours (0-27 h)|Modified Per Protocol population.|||Beats per minute||Standard Error|Least Squares Mean
2779337|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours|Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified Per Protocol population.|||msec||Standard Error|Least Squares Mean
2779443|NCT00673894|Secondary|Fructosamine|The blood concentration of the glycemic control marker fructosamine|4 weeks|The secondary aim of this randomized crossover study was to determine the glycemic effect of 4 weeks of glutamine (15 bd) supplementation with sitagliptin (100 mg/d) or placebo in type 2 diabetes patients treated with metformin.|||micro mol per litre||Standard Deviation|Mean
2779338|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours and 0 to 27 Hours|Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data .|From dosing until 4 hours (0-4h) and 27 hours (0-27h)|Modified Per Protocol population.|||msec||Standard Error|Least Squares Mean
2779339|NCT00674817|Secondary|Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(F) in Supine Position From 0 to 4 Hours|Analysis of QT(F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified per protocol population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Least Squares Mean
2779340|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 27 Hours After Dosing|Analysis of Q T (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data .|From dosing until 27 hours (0-27h)|Modified per protocol population|||msec||Standard Deviation|Mean
2779341|NCT00674817|Secondary|Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 4 Hours After Dosing|Analysis of QT (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as least square (LS) mean values while presenting the data.|From dosing until 4 hours (0-4h)|Modified per protocol population|||msec||Standard Deviation|Mean
2779342|NCT00674817|Secondary|Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings|Analysis QTc interval of ECG was performed by Bazett's formula (QTc B) and Fridericia's correction (QTc F). Number of participants with abnormal ECG findings were recorded. Any participant with QTc(B) or QTc(F) >500 milliseconds (msec) or uncorrected QT >600 msec (machine or manual over read) was withdrawn from the study. Participants that had right bundle branch block with QTc(B) or QTc(F) >530 msec were also withdrawn from the study.|From dosing until 24h post-dose.|All subjects population|||Participants|||Number
2779343|NCT00674817|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours|Heart rate was considered as a measure of vital sign. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.|Up to 27 hours post Day 1 dosing|All subjects population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2779344|NCT00674817|Secondary|Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours|Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was analyzed. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.|Up to 27 hours post Day 1 dosing|All subjects population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mm of Hg)||Standard Deviation|Mean
2779345|NCT00674817|Secondary|Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)|The normal ranges of laboratory parameters were hemoglobin: 130-167 grams per deciliter (g/dL), platelets: 173-383 Giga per liter (GI/L), lymphocytes: 20.1-44.5 %, glucose: 3.8857-6.106 millimoles per liter (mmol/L), creatinine: 44.2-132.6 micromoles per liter (uM/L) , aspartate transaminases (AST): 12-32 international units per liter (IU/L), total bilirubin (TB): 4.275-25.65 uM/L and potassium: 3.4-4.7 mmol/L, respectively. Laboratory values recorded outside the normal range were considered of potential clinical concern (PCC).|Up to 42 days|All subjects population|||Participants|||Number
2779346|NCT00674817|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Upto 82 days|All subjects population|||Participants|||Number
2779347|NCT00674817|Secondary|Maximal Change in Forced Vital Capacity (FVC) in One Second From Pre-dose in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h, 12h and 24h.|FVC is defined as the amount of air that can be forcibly exhaled from the lungs after a maximum inspiration as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.|Baseline (Pre-dose on Day 1), 1h, 12h, and 24h on Day 1|Modified per protocol population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2779348|NCT00674817|Primary|Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h.|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.|Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1|Modified per protocol population included the participants who received at least one dose of the study drug where major deviations from the protocol had not occurred. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2779349|NCT00674765|Primary|TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase|The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.|12 weeks||||percent days of heavy drinking|||Number
2779350|NCT00674739|Secondary|Treatment Related Adverse Events|Numbers of subjects in each treatment group reporting one or more adverse events|Up to 16 weeks|Patients with adverse events considered probably related or related to the administration of the product.|||Participants|||Number
2779444|NCT00673894|Primary|Postprandial Glucose Area Under the Curve (AUC)|The area under the curve (AUC) of the postprandial glucose following a meal challenge|0 to 180 minutes|The primary aim of this randomized crossover study was to determine the glycemic effect of 4 weeks of glutamine (15 bd) supplementation with sitagliptin (100 mg/d) or placebo in type 2 diabetes patients treated with metformin.|||mmol/L*t||Standard Deviation|Mean
2779351|NCT00674739|Primary|Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study|Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.|Up to 16 weeks|Intention to treat|||participants||95% Confidence Interval|Number
2779352|NCT00674739|Secondary|Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.|"Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.~Rest period was a temporary interruption of dosing dur to intolerable LSRs."|Up to 16 weeks||||participants|||Number
2779353|NCT00674700|Secondary|Average Rhinitis Total Symptom Score (ARTSS)|The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.|||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
2779354|NCT00674700|Primary|Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period|"The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).~It ranges from 0 to 12, the higher the score the more severe the rhinitis."|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.|||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
2779355|NCT00674661|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months||||diopters||Standard Deviation|Mean
2779356|NCT00674622|Secondary|Pain Threshold on Dolorimetry|Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.|6 and 12 weeks post-intervention||||Pounds||Standard Deviation|Mean
2779357|NCT00674622|Secondary|Nirschl Pain Phase Scale|"The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting No stiffness or soreness after activity and Phase 7 corresponding with Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity. It was used as an indication of severity for entry into the study and as the criterion for treatment response."|6 and 12 weeks post-intervention||||units on a scale||Standard Deviation|Mean
2779358|NCT00674622|Secondary|Grip Strength|Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.|6 weeks and 12 weeks post-intervention||||pounds||Standard Deviation|Mean
2779359|NCT00674622|Secondary|QuickDASH|"The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, & Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire Disabilities of the Arm, Shoulder, & Hand. It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability."|6 weeks and 12 weeks post-intervention||||units on a scale||Standard Deviation|Mean
2779360|NCT00674622|Primary|McGill Pain Questionnaire|This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.|6 weeks and 12 weeks post intervention||||units on a scale||Standard Deviation|Mean
2779361|NCT00674609|Primary|The Consumption of Escape Analgesic Medication.|Subjects recorded their use of escape medication each day on their diary card.|2 weeks: baseline - end of week 2 (last 3 days of treatment)|The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.|||tablets per day||Standard Deviation|Mean
2779362|NCT00674609|Secondary|Brief Pain Inventory Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|End of 2 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779445|NCT00673881|Primary|Total Cholesterol|Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)|12 weeks||||mg/dL||Standard Deviation|Mean
2779446|NCT00673881|Secondary|Endogenous Bile Acid Excretion|Change in endogenous bile acid excretion from baseline to end-of-treatment|12 weeks|||||||
2779363|NCT00674609|Secondary|EORTC Quality of Life Questionnaire (EORTC-QLQC30)|Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100|2 weeks; baseline and end of treatment (2 weeks)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779364|NCT00674609|Secondary|Concentration 0-10 Numerical Rating Scale|"The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper? where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779365|NCT00674609|Secondary|Appetite 0-10 Numerical Rating Scale|"The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your appetite has been throughout the day? where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779366|NCT00674609|Secondary|Memory 0-10 Numerical Rating Scale|"The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours? where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779367|NCT00674609|Secondary|Nausea 0-10 Numerical Rating Scale|"The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how sick you felt throughout the day? where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline."|2 weeks; baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779368|NCT00674609|Secondary|Sleep Disturbance 0-10 Numerical Rating Scale|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|2 weeks: baseline to end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.|||units on a scale||Standard Deviation|Mean
2779369|NCT00674609|Primary|The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.|"The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.|||units on a scale||Standard Deviation|Mean
2779370|NCT00674583|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to six months after vaccination (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2779371|NCT00674583|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2779372|NCT00674583|Secondary|Number of Subjects Reporting Specific Adverse Events|Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits.|Up to 6 months after vaccination (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2779435|NCT00674115|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days|25 participants in each arm had good quality tracings and were included in the efficacy analysis.|||pH scale||Full Range|Median
2809827|NCT00453206|Secondary|Disease-free Survival||monthly|||||||
2779373|NCT00674583|Secondary|Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
2779374|NCT00674583|Secondary|Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
2779375|NCT00674583|Secondary|Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 50 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
2779376|NCT00674583|Secondary|Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 30 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
2779377|NCT00674583|Secondary|Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations|Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2779378|NCT00674583|Secondary|Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2779379|NCT00674583|Primary|Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody|Vaccine response to MenC was defined as: -for initially seronegative subjects [i.e. rSBA-MenC titer below (<) 1:8], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|One month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2779380|NCT00674570|Primary|Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)|Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase.|15 minute measurement intervals on Study Days 7, 9, and 16||||proportion of max SCR (µS)||Standard Error|Mean
2779381|NCT00674492|Primary|Attributes of Treatment Experience|Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.|Zero to five years since ending treatment.||||participants|||Number
2779382|NCT00674479|Other Pre-specified|To Determine Pharmacodynamics Activity Including the Modulation of Signal Transducer and Activator of Transcription (STAT) Protein Phosphorylation.|The PD parameters will be calculated to explore preliminary evidence of PD activity by assessing the effect of INCB018424 on pre- and post-dose. If the p-STAT3/5 signaling data are sufficiently robust, an exploratory PK/PD analysis will be performed.|Up to 3 months|The lab data was not collected so the analysis could not be done.||||||
2779436|NCT00673959|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|upon instillation||||Units on a scale||Standard Deviation|Mean
2779447|NCT00673881|Secondary|Neutral Sterol Endogenous Excretion|Change in neutral sterol endogenous excretion from baseline to end-of-treatment|12 weeks|||||||
2779383|NCT00674479|Secondary|To Determine the Pharmacokinetics (PK) Activity|Exploratory sampling will be done to determine the INCB018424 PK profile. The PK parameters of INB018424 will be summarized using descriptive statistics, and the log-transformed INCB018424 PK parameters will be compared using a 1-factor analysis of variance. The mean values of the PK parameters may be compared to historical data in healthy volunteers to determine if the INCB018424 PK profile is different between patients with hematological malignancies and healthy patients.|Up to 3 months|INCB018424 PK profile was not done because there was no historical data to compare it to. Data for this Outcome were not collected.||||||
2779384|NCT00674479|Primary|Response Rate|"Time of Response  defined as the period of time from the date of first study drug administration until the first objective documentation of response. Clinical response is defined as Complete remission (CR) + Partial remission (PR) + CRp + Hematologic Improvement (HI). Participants in CR must be free of all symptoms related to leukemia and have an absolute neutrophil count (ANC) >/= 1x10^9/L, platelet count ./+ 100x10^9, normal marrow differential (</= 5% blasts). Partial remission (PR) is CR with 6-25% abnormal cells in the marrow or 50% decrease in marrow blasts. CRp is CR but platelet count < 100x10^9/L. HI is defined as for patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence."|Patients will be evaluated after each full cycle of therapy (28 days) for response.||||Participants|||Count of Participants
2779385|NCT00674466|Secondary|Reduction in Fasting Body Weight From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||kg||Standard Deviation|Mean
2779386|NCT00674466|Secondary|Reduction in Fasting Plasma Glucose From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||mg/dL||Standard Deviation|Mean
2779387|NCT00674466|Primary|Reduction of HbA1c From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||Percent (%)||Standard Deviation|Mean
2779388|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
2779389|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
2779390|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
2779391|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
2779392|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
2779393|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.|||Kappa Correlation Coefficient||95% Confidence Interval|Number
2779394|NCT00674362|Other Pre-specified|Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits|Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.|From Week 24 up to Week 52|"All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.~An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results."|||days||Standard Error|Mean
2779395|NCT00674362|Secondary|Change From Baseline in Fatigue Assessment Scale at Week 24|"Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method."|Baseline, Week 24|Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method|||units on a scale||Standard Deviation|Mean
2779437|NCT00673933|Secondary|Erythema Score (Mild and Moderate)1 Day After First Treatment|Patients with mild or moderate erythema 1 day after first treatment.|1 day after 1st treatment and baseline|ITT|||percentage of participants|||Number
2779438|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After Second Treatment|Patients with mild or moderate erythema after second treatment.|Immediately after second treatment, 2 weeks after baseline|ITT|||percentage of participants|||Number
2809828|NCT00453206|Secondary|Overall Survival||monthly|||||||
2779396|NCT00674362|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24|Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method|||mm||Standard Deviation|Mean
2779397|NCT00674362|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24|Change from Baseline in Patient's Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method|||mm||Standard Deviation|Mean
2779398|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779399|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779400|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779401|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779402|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779403|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779404|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779405|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779406|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779439|NCT00673933|Secondary|Change in Noninflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT|||lesion count||Standard Deviation|Mean
2809829|NCT00453206|Secondary|Complete Response||monthly|||||||
2779407|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.|||units on a scale||Standard Deviation|Mean
2779408|NCT00674362|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2779409|NCT00674362|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 24|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
2779410|NCT00674362|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 24|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
2779411|NCT00674362|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
2779412|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits|DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||Days||Standard Deviation|Mean
2779413|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||days||Standard Deviation|Mean
2779414|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||days||Standard Deviation|Mean
2779415|NCT00674362|Secondary|Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
2779440|NCT00673933|Secondary|Change in Inflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT|||lesion count||Standard Deviation|Mean
2779441|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After First PDT|Patients with mild or moderate erythema after first treatment at baseline.|Immediately after treatment at baseline|ITT|||percentage of participants|||Number
2779416|NCT00674362|Secondary|28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24|DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis|||percentage of subjects|||Number
2779417|NCT00674362|Primary|Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
2779418|NCT00674323|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.|||Letters||Standard Deviation|Mean
2779419|NCT00674323|Secondary|Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)|High resolution 6 meridian scans were performed to measure central retinal thickness.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.|||micrometers||Standard Deviation|Mean
2779420|NCT00674323|Secondary|Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Baseline through end of study (6 months)|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.|||Participants|||Number
2779421|NCT00674323|Primary|Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.|||Participants|||Number
2779422|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL)|3 months||||ng/mL||Standard Deviation|Mean
2779423|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarker sTF (pM)|3 months||||pM||Standard Deviation|Mean
2779424|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarkers: IL6 (pg/mL), IL1β (pg/mL), IL8 (pg/mL), VEGF (pg/mL), TNFα (pg/mL), IFNα (pg/mL), IP10 (pg/mL), sCD40L (pg/mL)|3 months||||pg/mL||Standard Deviation|Mean
2779425|NCT00674219|Primary|Psychometric Scores|"Participants in the OCD group were rated using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a standard measure of obsessive-compulsive disorder (OCD) severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 10 items assessing OCD symptoms (e.g. time spent, degree of control, severity). Each item is scored on a scale from 0 (not present) to 4 (severe) [total score range = 0-40] over the previous week. The higher the number on the Y-BOCS, the more severe the symptoms.~Participants in the GAD group were rated using the Hamilton Anxiety Rating Scale (HARS), a standard measure of anxiety severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 14 items assessing anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe."|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2779426|NCT00674206|Secondary|Overall Survival From Time of Study Entry|"The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived.~Note: Not all patients started the study at the same time so the time frame is different from the full range.~The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived."|132 weeks||||Weeks||Full Range|Median
2779427|NCT00674206|Primary|Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.|"A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions.~Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|8 weeks||||participants|||Number
2779428|NCT00674154|Secondary|Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm||one year|||||||
2779429|NCT00674154|Secondary|Increased Bone Mineral Density||One year|||||||
2779430|NCT00674154|Secondary|Increase in Quality of Life||One year|||||||
2779431|NCT00674154|Secondary|Reduced Postoperative Hypocalcemia||Postoperative week|||||||
2779432|NCT00674154|Secondary|Improved Muscular Function||One Year|||||||
2815293|NCT00417027|Secondary|Manual Bolus Doses Administered||Duration of labor analgesia||||participants|||Number
2779450|NCT00673881|Secondary|Percent Change in de Novo Cholesterol Synthesis|Plasma DNC was measured three times from blood draws on the 3 visits in the 10 day period following the isotope infusion at baseline and again at end-of-treatment at 12 weeks, and expressed in percent. Change from baseline to end-of-treatment expressed as percent.|Baseline to 12 weeks|||||||
2779451|NCT00673881|Secondary|Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)|Change in FCR from baseline to end-of-treatment (12 weeks)|Baseline to 12 weeks|||||||
2779452|NCT00673881|Secondary|Plasma Cholesterol Efflux|Change in efflux rate from baseline to end-of-treatment. The efflux rate of cholesterol from peripheral tissues into the plasma was measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® or Liposyn® and 10 % ethanol was given piggy-backed into normal saline over 24 hours. This was used to determine rate of appearance (Ra) cholesterol, measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol traced into biliary sterols.|12 weeks|||||||
2779453|NCT00673881|Primary|Mean Change in High Density Lipoprotein Cholesterol|Mean change in plasma high density plasma lipoprotein cholesterol (HDL-C)baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|Baseline to 12 weeks||||mg/dL||Standard Deviation|Mean
2779454|NCT00673881|Primary|Mean Change in Plasma Triglycerides|Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|baseline to 12 weeks|per protocol|||mg/dL||Standard Deviation|Mean
2779455|NCT00673881|Primary|Mean Change in Calculated Low Density Lipoprotein Cholesterol|Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)|baseline to 12 weeks||||mg/dL||Standard Deviation|Mean
2779456|NCT00673855|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|Three minutes||||Units on a scale||Standard Deviation|Mean
2779457|NCT00673816|Secondary|Change in Retinal Angioma Leakage From Baseline to Week 36|"Leakage of the retinal angioma was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume."|Baseline and 36 Weeks|||||||
2779458|NCT00673816|Secondary|Change in Retinal Thickness From Baseline to Week 36|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 36 Weeks||||µm|||Number
2779459|NCT00673816|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 36 Weeks||||ETDRS Letters|||Number
2779460|NCT00673790|Secondary|Plasma Glucose Level After an Oral Glucose Tolerance Test|Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.|Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)|The between–treatment-group comparison was performed by means of an analysis-of-covariance model with treatment group and study center as factors and baseline value as a covariate based on Intent-to-Treat (ITT) population.|||g/mL||Standard Error|Least Squares Mean
2779461|NCT00673790|Primary|Trough Seated Diastolic Blood Pressure|Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).|Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)|The between–treatment-group comparison was performed by means of an analysis-of-covariance model with treatment group and study center as factors and baseline value as a covariate based on Intent-to-Treat (ITT) population. As pre-specified in the protocol, the change in seated DBP was performed between the nebivolol and placebo group.|||mm Hg||Standard Deviation|Mean
2779462|NCT00673764|Secondary|Functional Blink Rate Time (Time Between Blinks)|Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.|15 minutes, 45 minutes, and 90 minutes post-dose||||seconds||Standard Deviation|Mean
2779463|NCT00673764|Primary|Time at Best Corrected Visual Acuity|Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.|15 minutes, 45 minutes, and 90 minutes post-dose||||seconds||Standard Error|Median
2779464|NCT00673738|Secondary|Overall Response Rate (ORR)|ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 36 months|All participants|||percentage of participants||95% Confidence Interval|Number
2779465|NCT00673738|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from randomization until death from any cause.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
2779466|NCT00673738|Primary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
2779467|NCT00673712|Secondary|Hospital Length of Stay|time (days) from date of admission to discharge|primary admission|all randomized subjects|||days||Standard Deviation|Mean
2779468|NCT00673712|Secondary|Surgical Site Infection|surgical site infection diagnosed within 30 days post surgery|30 days postoperative|all randomized subjects|||participants|||Number
2788188|NCT00607672|Secondary|Vasopressor Drug Use||From the end of cardiopulmonary bypass until arrival in intensive care unit||||percentage of patients|||Number
2779471|NCT00673673|Secondary|Overall Tumor Response Rate by RECIST Criteria|"Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Upon completion of study||||percentage of participants|||Number
2779472|NCT00673673|Primary|Progression Free Survival||Upon completion of study, up to 3 years||||months||95% Confidence Interval|Median
2779473|NCT00673660|Secondary|Number of Participants With Reasons of Non-compliance to Statin Treatment|Participants were called for a final visit and reasons for non-compliance were recorded.|Month 12|Primary analysis population, subset of evaluable participants|||participants|||Number
2779474|NCT00673660|Secondary|Number of Participants With Reasons of Compliance to Statin Treatment|Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.|Month 12|Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed.|||participants|||Number
2779475|NCT00673660|Secondary|Available Lipid Profiles of Compliant and Non-compliant Participants|Available laboratory measurements of participants were recorded in CRFs.|Month 12|Primary analysis population, subset of evaluable participants.|||milligrams per deciliter||Standard Deviation|Mean
2779476|NCT00673660|Primary|Percentage of Participants Who Were Compliant With Statin Treatment|The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.|Month 12|Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.|||Percentage of participants|||Number
2779477|NCT00673595|Secondary|24-hour Ambulatory Blood Pressure|Ambulatory blood pressure will be measured using the Spacelabs 90202 recorder. Systolic and diastolic blood pressure during the 24-hour period will be analyzed.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.|||mm Hg||Standard Deviation|Mean
2779478|NCT00673595|Primary|Arterial Endothelial Function as Measured by Flow-mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.|||mm||Standard Deviation|Mean
2779479|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Tmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.||||||
2779480|NCT00673465|Secondary|Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).||||||
2779481|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Cmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.||||||
2779482|NCT00673465|Secondary|Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).||||||
2779483|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.||||||
2779484|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of type 2 diabetes mellitus [T2DM] participants after four weeks of treatment with SCH 497079 vs. placebo).||||||
2779485|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|No participants were randomized to treatment during Part 2 of the study.||||||
2779486|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|All participants who completed study treatment with at least SCH 497079 and placebo.|||mg/dL||Standard Error|Least Squares Mean
2779487|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.||||||
2779488|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.|||mg/dL||Standard Error|Least Squares Mean
2779489|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|No participants were randomized to treatment during Part 2 of the study.||||||
2779490|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|All randomized participants.|||Participants|||Number
2779491|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.||||||
2779492|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.|||mg/dL||Standard Error|Least Squares Mean
2779493|NCT00673452|Secondary|Change From Baseline in Weight at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.|||kilograms (kg)||Standard Error|Least Squares Mean
2779550|NCT00673257|Secondary|Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count|Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values|Length of Study|||||||
2779494|NCT00673452|Secondary|Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)|"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline through 12 Weeks|Number of randomized patients.|||participants|||Number
2779495|NCT00673452|Secondary|Change From Baseline in Heart Rate at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2779496|NCT00673452|Secondary|Change From Baseline in Blood Pressure at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.|||mm Hg||Standard Error|Least Squares Mean
2779497|NCT00673452|Secondary|Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint|Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 weeks|Number of randomized patients with baseline and at least one post-baseline data.|||participants|||Number
2779498|NCT00673452|Secondary|Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint|Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 Weeks|Number of randomized patients with baseline and at least one post-baseline data.|||participants|||Number
2779499|NCT00673452|Secondary|Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint|Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779500|NCT00673452|Secondary|Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint|"The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = greater than normal to 6 = totally absent. Total score ranges from 7 to 42."|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779501|NCT00673452|Secondary|Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks|The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779502|NCT00673452|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779503|NCT00673452|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint|The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779504|NCT00673452|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint|BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779505|NCT00673452|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint|MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.|||units on a scale||Standard Error|Least Squares Mean
2779551|NCT00673257|Secondary|Relationship Between Pharmacokinetics and Toxicity|Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities|Length of Study|||||||
2779506|NCT00673452|Secondary|Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint|BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2779507|NCT00673452|Primary|Patient's Global Impressions of Improvement (PGI-I) at Week 12|"The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is very much improved, a score of 4 indicates that the patient has experienced no change, and a score of 7 indicates that the patient is very much worse."|12 weeks|Number of randomized patients with baseline PGI-S and at least one post-baseline PGI-I data.|||units on a scale||Standard Error|Least Squares Mean
2779508|NCT00673439|Secondary|the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux||4 weeks after INR reaches 2 or more||||Participants|||Count of Participants
2779509|NCT00673439|Primary|Number of Participants Showing Clinically Significant Bleeding|Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux|4 weeks after INR reaches 2 or more||||participants|||Number
2779510|NCT00673400|Other Pre-specified|SF36 Component Summary Scores|"Quality of life short form 36 version 2(SF36v2) standard form~PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best)~A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10)~Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000."|Before surgery - 6 months||||units on a scale||Inter-Quartile Range|Median
2779511|NCT00673400|Other Pre-specified|Obstructive Defecation Syndrome Score|"Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered)~(0 - 40, no symptoms = 0)~Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1)"|before surgery - 6 weeks -3 months - 6 months||||units on a scale||Inter-Quartile Range|Median
2779512|NCT00673400|Other Pre-specified|Severity of Symptoms Score|"Score based on the severity of 9 symptoms of bowel movement (physician administered)~(0 - 36, no symptoms = 0)~Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950)"|before surgery - 6 weeks - 3 months - 6 months||||units on a scale||Inter-Quartile Range|Median
2779513|NCT00673400|Secondary|Hospitalization|Length of hospital stay (Date of release - Date of admission + 1)|1 day to 1 year (until release from hospital)||||days||Full Range|Median
2779514|NCT00673400|Secondary|Morbidity|Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)|1 year||||participants|||Number
2779515|NCT00673400|Primary|Quality of Life|"Quality of life is measured by Fecal incontinence quality of life (FIQL)~Possible range of score 0 - 4 (Depression/Self perception 4.4)~0 = worst condition~Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)"|6 months after intervention|Participating in the FIQL survey was voluntarily. Some patients did not participate at all, some did not answer all questions. Patients answering >=50% of questions of a domain were counted as participants|||units on a scale||Inter-Quartile Range|Median
2779516|NCT00673387|Secondary|Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening (visit 2), Day 1, Weeks 1, 12, 28 (study termination). Heart Rate was measured in beats per min (bpm).|Screening to Week 28 (or early termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.|||bpm||Standard Deviation|Mean
2779517|NCT00673387|Secondary|Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening, Day 1, Weeks 1, 12, 28 (study termination). The PR interval, which is time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval (time from the beginning to the end of the QRS complex); QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 28 (or study termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.|||msec||Standard Deviation|Mean
2779518|NCT00673387|Secondary|Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||participants|||Number
2779519|NCT00673387|Secondary|Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||bpm||Standard Deviation|Mean
2780298|NCT00667251|Secondary|Overall Survival|OS median follow-up not achieved; estimated with quartile estimates|From randomization to death from any cause, assessed up to 44 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)|||Months||Inter-Quartile Range|Median
2779520|NCT00673387|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||mm Hg||Standard Deviation|Mean
2779521|NCT00673387|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Obtained at: Screening, Days -7, 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of laboratory values are cumulative across the study. Criteria for values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma/serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||Number of Laboratory Values|||Number
2779522|NCT00673387|Secondary|Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of values are cumulative across the study.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.|||Number of Laboratory Values|||Number
2779523|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Error|Mean
2779524|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population|The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire which assesses sleep quality and sleep disturbances over a period of 1 month. The PSQI provides ratings on seven domains of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). The sum of the individual domains yields a global sleep quality score with a range of 0-21. A PSQI score >5 is indicative of poor sleep, which is characterized by severe difficulties in at least two domains, or moderate difficulties in three or more domains. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
2779525|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population|The POMS is a mood scale consisting of 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each of the six POMS factors. The mood adjectives load onto 6 mood factors, which are as follows: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. The factor scores are added to obtain the total mood disturbance score. A lower total mood disturbance score indicates improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Error|Mean
2779526|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The higher the score, the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Error|Mean
2779548|NCT00673309|Primary|Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study|Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.|Admission to burn unit to 95% wound healing|Shriner’s Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.||||||
2779527|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale (ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores indicate improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
2779528|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. The minimum and maximum score for the BES instrument is 0 and 55, respectively. The higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
2779529|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population|Subjective effects of weight loss were measured using the IWQOL-Lite questionnaire, a 31-item patient reported outcome (PRO) instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items have a range of 1 to 5 with 5=always true and 1= never true. The total score for the IWQOL-Lite instrument is measured on a scale from 0 (worst) to 100 (best). Higher scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.|||units on a scale||Standard Deviation|Mean
2779530|NCT00673387|Secondary|Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. Parameter was measured micro international units per milliliter. (µIU/mL).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding.|||µIU/mL||Standard Error|Least Squares Mean
2779531|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. All parameters were measured in milligrams per deciliter (mg/dL).|Baseline to Week 28|Evaluable population: received at least one dose of randomized treatment, had adequate exposure to treatment, complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) presented above for TC, LDL and HDL cholesterol. Glucose n= 43, 50, 41, 46, 45, 43,44,36; Triglycerides n= 44,50,41,46,45,44,44.38.|||mg/dL||Standard Error|Least Squares Mean
2779532|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray Absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Fat-free mass were measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.|||kg||Standard Error|Least Squares Mean
2779533|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.|||kg||Standard Error|Least Squares Mean
2779542|NCT00673387|Primary|Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population|Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups).|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.|||Percentage change in kg||95% Confidence Interval|Least Squares Mean
2779534|NCT00673387|Secondary|Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline.|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.|||percentage of body fat||Standard Error|Least Squares Mean
2779535|NCT00673387|Secondary|Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL).|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively.|||pg/mL||Standard Error|Geometric Mean
2779536|NCT00673387|Secondary|Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms*hour/milliliter (pg*h/mL).|Weeks 4 and 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively.|||pg*h/mL||Standard Error|Geometric Mean
2779537|NCT00673387|Secondary|Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms*hour/milliliter (pg*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection.|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36.|||pg*h/mL||Standard Error|Geometric Mean
2779538|NCT00673387|Secondary|LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population|Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm).|Baseline to Weeks 12 and Week 28|Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively.|||cm||Standard Error|Least Squares Mean
2779539|NCT00673387|Secondary|LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population|Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.|||kg||95% Confidence Interval|Least Squares Mean
2779540|NCT00673387|Secondary|Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc.|Baseline to Week 28|Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented.|||ng/mL||Standard Deviation|Mean
2779541|NCT00673387|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population|Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.|||participants|||Number
2779543|NCT00673361|Secondary|Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria||post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years|||||||
2779544|NCT00673361|Primary|Progression Free Survival (PFS)|Terminated study before accrual goal, no data analysis|3 weeks, 6 weeks, 16 weeks, & 24 weeks|||||||
2779545|NCT00673309|Secondary|Incidence of Sepsis|Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.|Admission to burn unit to 95% wound healing|||||||
2779552|NCT00673257|Secondary|Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background|Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (<median age versus >=median age in years), Race (White vs. Black vs. Other)|Length of Study|||||||
2779553|NCT00673257|Secondary|Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride|Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%)|Length of study|||||||
2779554|NCT00673257|Primary|Population Estimates for Daunorubicin Hydrochloride Volume of Distribution|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.|Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.|||Liter||Standard Deviation|Mean
2779555|NCT00673257|Primary|Population Estimates for Daunorubicin Hydrochloride Clearance|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.|Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.|||L/m2/hr||Standard Deviation|Mean
2779556|NCT00673231|Other Pre-specified|Proportion of Participants With Lack of Glycemic Control|Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets|Baseline to Week 24|Full Analysis Set|||Participants|||Number
2779557|NCT00673231|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2779558|NCT00673231|Secondary|Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction|To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2779559|NCT00673231|Secondary|Adjusted Mean Change in Calculated Mean Daily Insulin Dose|To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||IU/day||95% Confidence Interval|Least Squares Mean
2779560|NCT00673231|Secondary|Adjusted Mean Change in Body Weight|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2779561|NCT00673231|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
2779562|NCT00673179|Secondary|Quality of Life (Ped QL) Assessment||Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.|||||||
2779563|NCT00673179|Primary|Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)|Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.|Baseline to 5 Years|Study terminated early without analysis.||||||
2779564|NCT00673153|Secondary|Number of Participants Alive at Day 30 (Good-risk Group)||At day 30|Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1|||Participants|||Count of Participants
2779565|NCT00673153|Secondary|Number of Participants Achieving CR or CRi With Induction Therapy (Poor-risk Group)||after completion of induction therapy, administered every 21-42 days for up to two courses|Poor-risk Group: patients aged ≥70 years and performance status 2-3|||Participants|||Count of Participants
2779566|NCT00673153|Secondary|Relapse-free Survival (Good- and Poor-risk Group)||At relapse|Poor-risk Group: patients aged ≥70 years and performance status 2-3; Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1|||Participants|||Count of Participants
2779567|NCT00673153|Primary|Number of Participants Alive at Day 30 (Poor-risk Group)||At day 30|Poor-risk Group: patients aged ≥70 years and performance status 2-3|||Participants|||Count of Participants
2779568|NCT00673153|Primary|Number of Participants Achieving CR or CRi With Induction Therapy (Good-risk Group)||after completion of induction therapy, administered every 21-42 days for up to two courses|Good-risk Group: aged 60-69 years with performance status 0-3, or aged ≥70 years and performance status 0-1|||Participants|||Count of Participants
2779569|NCT00673127|Secondary|Time to Progression|Duration of time from treatment initiation until documented progression (PSA or Disease progression)|Duration of time from treatment initiation until documented progression. Maximum 32 months||||months||95% Confidence Interval|Median
2779570|NCT00673127|Primary|PSA Response|PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.|From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.||||percentage of participants||95% Confidence Interval|Number
2779571|NCT00673114|Secondary|Number of Participants With Donor Cells at 100 Days Post-transplant||Post transplant||||participants|||Number
2779572|NCT00673114|Secondary|Rates of Leukemic Relapse|Number of participants relapsed|Up to 2 years post transplant||||participants|||Number
2779573|NCT00673114|Secondary|Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)|Acute and chronic GVHD|two years||||participants|||Number
2779574|NCT00673114|Secondary|Incidence of Primary and Secondary Graft Failure|Number of participants experiencing graft failure.|100 days post transplant||||participants|||Number
2779575|NCT00673114|Secondary|Platelet Engraftment (Untransfused and Platelet Count > 50,000)|Participants platelet engrafted.|Approximately 1 year||||participants|||Number
2779576|NCT00673114|Secondary|Non-Relapse Mortality at 180 Days Post Transplant||180 days||||participants|||Number
2779577|NCT00673114|Secondary|180 Day Survival|Number of participants alive at 180 days post transplant|180 days||||participants|||Number
2779578|NCT00673114|Primary|The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).||By day 100||||participants|||Number
2779579|NCT00673075|Secondary|Left Ventricular Ejection Fraction (LVEF) (%) at Week 18|Left ventricular ejection fraction (LVEF) (%) at Week 18|18 weeks post-treatment||||percentage||Standard Error|Mean
2779580|NCT00673075|Secondary|Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|18 weeks post-treatment||||participants|||Number
2779581|NCT00673075|Secondary|Peripheral Systolic Blood Pressure (SBP)|Peripheral systolic blood pressure (SBP) at visit 13 (week 18)|18 weeks post initiation of randomized treatment||||mmHg||Standard Error|Mean
2779582|NCT00673075|Primary|Peripheral Diastolic Blood Pressure (DBP)|Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)|18 weeks post initiation of randomized treatment||||mmHg||Standard Error|Mean
2779583|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)|QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).||||||
2779584|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)|EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).||||||
2779585|NCT00673049|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.||||||
2779586|NCT00673049|Secondary|Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)||Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore biomarker results were not analyzed.||||||
2779603|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
2779587|NCT00673049|Secondary|Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group|"Analysis population included all participants treated with figi. Data are combined for figi+erlo and erlo then figi because the objective was to report any participants with positive ADA after exposure to figi regardless of figi administration order, rather comparison of these 2 treatment groups. N=number of participants evaluable."|||percentage of participants|||Number
2779588|NCT00673049|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.||||||
2779589|NCT00673049|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.||||||
2779590|NCT00673049|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response (OR) based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR are defined as complete disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
2779591|NCT00673049|Secondary|Progression Free Survival (PFS)|Time from randomization to date of first documentation of progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, who had a baseline and at least 1 on-study disease assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.|||months||95% Confidence Interval|Median
2779592|NCT00673049|Primary|Overall Survival|The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.|Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.|||months||95% Confidence Interval|Median
2779593|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||ng.h/ml||Standard Deviation|Mean
2779594|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||ng.h/ml||Standard Deviation|Mean
2779595|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||hours||Standard Deviation|Mean
2779596|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||hours||Standard Deviation|Mean
2779597|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population|||ng/ml||Standard Deviation|Mean
2779598|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|Pharmacokinetic (PK) population consists of all subjects in the safety population (subjects who had taken one dose of study medication and had one follow-up safety assessment completed) who had evaluable concentration-time profiles.|||ng/ml||Standard Deviation|Mean
2779599|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
2779600|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
2779601|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 6||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||bpm||Standard Error|Least Squares Mean
2779602|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 1||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||bpm||Standard Error|Least Squares Mean
2779668|NCT00672555|Secondary|Body Image Score|Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20.|1 year||||Units on a scale||Standard Deviation|Mean
2779604|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
2779605|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population|||msec||Standard Error|Least Squares Mean
2779606|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline, Tmax (time of subject-specific maximum plasma concentration)|"Pharmacodynamic (PD) population consists of all evaluable subjects with no major protocol deviations. Evaluable subjects were defined as subjects who received a Day 6 dose and had Day 6 data for the primary and secondary endpoints for all three periods."|||msec||Standard Error|Least Squares Mean
2779607|NCT00672958|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 6|Full analysis set.|||participants|||Number
2779608|NCT00672958|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where data were available; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2779609|NCT00672958|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where Baseline SF-36 data were available; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2779610|NCT00672958|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779611|NCT00672958|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779612|NCT00672958|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779623|NCT00672854|Secondary|Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization|Mortality is defined as death occurring during admission, either during the time PN is received or after PN treatment is completed. Death during hospitalization rather than during PN treatment was chosen because many patients who undergo treatment with PN die or develop hospital complications within a period of several days after treatment cessation. The number of deaths between the two groups are compared.|During Parenteral Nutrition (up to 28 days post randomization)||||participants|||Number
2779613|NCT00672958|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A)|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779614|NCT00672958|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779615|NCT00672958|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6.|Baseline to Week 6|Full analysis set. Participants with missing values were classified as nonsustained responders/remitters.|||percentage of participants|||Number
2779616|NCT00672958|Secondary|Percentage of Participants in MADRS Remission at Week 6|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 6|Full analysis set; LOCF was used.|||percentage of participants|||Number
2779617|NCT00672958|Secondary|Percentage of Responders in HAM-D24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2779618|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4 and 5|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779619|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 6|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
2779620|NCT00672932|Primary|Change in CSF Concentrations of Neopterin After 12 Weeks|CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.|||nmol/L||Standard Deviation|Mean
2779621|NCT00672932|Secondary|Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR|Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.|||percentage of cells||Standard Deviation|Mean
2779622|NCT00672854|Secondary|Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups|Change in immune function is assessed by percentage of Granulocyte phagocytosis after 7-day administration of parenteral nutrition between the two treatment groups. The phagocytic and oxidative burst activity of monocytes and granulocytes in heparinized whole blood was assessed according to manufacturer's instructions using specific reagent kits for this purpose at baseline and again at day 7. Briefly, granulocyte phagocytic activity was quantitated by incubation of whole blood with fluorescein isothiocyanate-labeled, opsonized Escherichia coli bacteria at 37°C with detection of fluorescence of internalized particles as a percentage of positive cells by flow cytometry.|Baseline and 7 days post randomization||||percentage of phagocytosis||Standard Deviation|Mean
2790695|NCT00589472|Secondary|Levels of PSA in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/mL||95% Confidence Interval|Median
2779624|NCT00672854|Secondary|Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups|Mean hospital blood glucose is measured as an indicator for insulin sensitivity. Capillary blood glucose was measured with a glucose meter at bedside during PN infusion. For this study normal blood glucose levels were indicated as 70-200 mg/dL, any blood glucose level < 70 mg/dL is regarded as hypoglycemia and above 200 mg/dL is regarded as hyperglycemia.|During Parenteral Nutrition (up to 28 days post randomization)||||mg/dL||Standard Deviation|Mean
2779625|NCT00672854|Secondary|Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups|Mean Plasma concentration of circulating levels of oxidative stress markers like levels of cystine at baseline, day 3, and day 7 are measured and compared between the soybean oil- and olive oil-based parenteral nutrition infusion groups. Levels were measured using iodoacetate to alkylate free thiols, derivatization with dansyl chloride to fluorescently tag amino groups, and high pressure liquid chromatography (HPLC) and fluorescence to separate, detect, and quantify the molecules.|Baseline, Day 3 and Day 7||||micromol per liter||Standard Deviation|Mean
2779626|NCT00672854|Secondary|Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups|Plasma concentration of circulating levels of inflammatory stress markers like tumor necrosis factor-alpha is measured at baseline, day 3, and day 7 among soybean oil- and olive oil-based parenteral nutrition infusion groups. The normal reference values are < or =2.8 pg/mL. Levels were measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the Immulite analyzer.|Baseline, Day 3 and Day 7||||pg/mL||Standard Deviation|Mean
2779627|NCT00672854|Secondary|Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured|Peripheral blood samples will be analyzed for circulating levels of inflammatory markers markers like plasma C-reactive protein (CRP) at baseline, day 3, and day 7 of soybean oil- and olive oil-based parenteral nutrition infusion and compared. A reading of less than 1 mg/L indicates low risk; a reading between 1 and 2.9 mg/L indicates intermediate risk; a reading greater than 3 mg/L indicates high risk and a reading above 10 mg/L indicates a need for further testing. Since the patients are sick and hospitalized, it is expected that their levels are elevated compared to normal subjects. The levels between the 2 groups are compared to see if there is any difference.Levels were measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the Immulite analyzer.|Baseline, Day 3 and Day 7||||mg/L||Standard Deviation|Mean
2779628|NCT00672854|Secondary|Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups|The mean number of days patients stayed in the intensive care unit between the Intralipid 20% and ClinOleic 20% while they are on parenteral nutrition is calculated and compared|During Parenteral Nutrition (up to 28 days post randomization)||||days||Standard Deviation|Mean
2779629|NCT00672854|Primary|Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay|New nosocomial infections, defined as culture-proven infection including wound, drain, bloodstream, respiratory tract, and urinary tract infections during PN. The presence of nosocomial infections was diagnosed based on standardized Centers for Disease Control (CDC) guidelines for laboratory-confirmed bloodstream infection and did not distinguish catheter-related infections per se. The following daily information was evaluated by the study team for nosocomial infection surveillance: temperature (fever)curve, white blood cell counts, review of daily progress notes in the medical record, daily clinical microbiology laboratory culture data, orders for antimicrobial agents (agent, daily dose, and start/stop times will be recorded), review of all relevant dictated radiographic reports (e.g., chest radiographs, abdominal computer tomography), communication, as needed, with primary physicians and site infectious disease consultants, and use of the CDC guidelines.|2 days after Parenteral Nutrition (up to 28 days post randomization)||||number of nosocomial infections|||Number
2779630|NCT00672841|Primary|Safety and Tolerability of Preemptive Anidulafungin|reported as the Number of Adverse Events Possibly Related to Study Drug|weekly until ICU discharge|Subjects receiving at least 1 dose of anidulafungin were assessed.|||events|||Number
2779631|NCT00672841|Secondary|Incidence of Proven or Probable Invasive Fungal Infection (IFI)|Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.|Participants were followed until ICU discharge, an average of 17 days|4 subjects in the preemptive therapy were excluded from this analysis. These subjects were treated with empiric antifungal therapy despite repeatedly negative glucan results.|||participants|||Number
2779632|NCT00672841|Secondary|Validate Gene Expression Signatures Predictive of IC||Study Completion, an average of 17 days|Data was not collected for this outcome measure.||||||
2779633|NCT00672841|Primary|Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.|Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.|Participants were followed until ICU discharge, an average of 17 days|Two study subjects in the preemptive therapy arm were excluded from the analysis of assay sensitivity and specific due to icteric serum specimens.|||participants|||Number
2779634|NCT00672737|Primary|Experimental Heat-induced Pain - SaO2|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography), on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||['C/(mcg/mL)] /%||95% Confidence Interval|Mean
2783609|NCT00640224|Secondary|Percent Body Fat at Baseline and 6 Months|DXA scans were done to measure the percentage of body fat.|Baseline and 6 months||||percentage of body fat||Standard Error|Mean
2779635|NCT00672737|Primary|Experimental Cold-induced Pain - SaO2|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by nadir SaO2 during polysomnography) on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the SaO2. For example, for every 1-%-absolute decrease in the nadir SaO2, the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||[sec/(mcg/mL)] /%||95% Confidence Interval|Mean
2779636|NCT00672737|Primary|Experimental Heat-induced Pain - IGFBP-1|The effect of arterial oxyhemoglobin desaturation during sleep (chronic intermittent hypoxia expressed by insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of heat-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated betas (95% CI), indicating how much the change in the heat pain threshold (expressed in C') under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in serum level of IGFBP-1, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||['C/(mcg/mL)] /pg/mL||95% Confidence Interval|Mean
2779637|NCT00672737|Primary|Experimental Cold-induced Pain - IGFBP-1|The effect of insulin growth factor binding protein-1 (IGFBP-1), a serum hypoxia marker, on the change of cold-induced pain thresholds under remifentanil was estimated using a mixed linear regression model. The results were expressed by the estimated beta (95% CI), indicating how much the change in the cold pain threshold (expressed in seconds) under remifentanil, was altered per unit of change in the IGFBP-1. For example, for every 1-pg/mL increase in the serum level of IGFBP-1, cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|2 to 3 weeks|Volunteers with evaluable data were included in the analysis.|||[sec/(mcg/mL)] /pg/mL||95% Confidence Interval|Mean
2779638|NCT00672646|Secondary|VAS Pain on Jaw Movement at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.|||Units on a VAS scale||Full Range|Median
2779639|NCT00672646|Secondary|VAS Pain Intensity at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.|||units on a VAS scale||Full Range|Median
2779640|NCT00672646|Secondary|Time to First Meaningful Pain Relief|First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours||||hour||Inter-Quartile Range|Median
2779641|NCT00672646|Secondary|Time to First Perceptible Pain Relief|First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours||||hour||Inter-Quartile Range|Median
2779642|NCT00672646|Secondary|Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)|0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.|Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.||||units on VAS scale||Full Range|Median
2779643|NCT00672646|Primary|Sum of Pain Intensity Difference in Percent (SPID%)|Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours||||percentage of pain intensity change * h||Full Range|Median
2779644|NCT00672633|Secondary|HDL Cholesterol|High Density Lipoprotein Cholesterol|3 months|Intention to Treat|||mg/dL||Standard Error|Mean
2779645|NCT00672633|Secondary|LDL Cholesterol|Low Density Lipoprotein Cholesterol|3 months||||mg/dL||Standard Error|Mean
2779646|NCT00672633|Primary|Fasting Triglycerides|Fasting Triglycerides|3 months|Intention to Treat|||mg/dL||Standard Error|Geometric Mean
2779647|NCT00672620|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
2779667|NCT00672555|Secondary|Cosmetic Score|Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24.|1 year||||Units on a scale||Standard Deviation|Mean
2780312|NCT00666978|Secondary|Number of Participants for Each CYP2B6 Allele|We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.|Week 3||||Participants|||Count of Participants
2779648|NCT00672620|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
2779649|NCT00672620|Secondary|Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779650|NCT00672620|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779651|NCT00672620|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8|"Full analysis set with available data at Baseline; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779652|NCT00672620|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779653|NCT00672620|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779654|NCT00672620|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
2779655|NCT00672620|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|Baseline to Week 8|Full analysis set with available data.|||percentage of participants|||Number
2779656|NCT00672620|Secondary|Percentage of Responders in HAM-D 24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
2779657|NCT00672620|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Weeks 1, 2, 4, and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
2779658|NCT00672620|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug and had at least 1 valid postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
2779659|NCT00672594|Primary|Change in Proliferation Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis|||Percentage of Ki67 positive nuclei||Standard Deviation|Mean
2779660|NCT00672594|Secondary|Interstitial Fluid Pressure (IFP)|Measure Interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic evidence of treatment effect.Eligible patients who sign consent will undergo a baseline transrectal ultrasound (TRUS)-guided measurement of tumor IFP. Participants will then begin treatment with daily oral Sunitinib malate with biweekly monitoring for response and toxicity. After 4 weeks of therapy, patients undergo a repeat TRUS and tumor IFP measurement. Following a 1 to 2 week wash out period, patients undergo prostatectomy with pathologic tissue collection. This will be performed as a means to evaluate whether Sunitinib malate has the ability to decrease tumor IFP, and whether this correlates with other tr|4 years|This was an optional test and no patients chose to participate.||||||
2779661|NCT00672594|Secondary|Difference in Gene Expression Patterns Using Microarray Analysis|Microarray data of 21 specimens from men enrolled who have undergone a prostatectomy and study treatment were compared to data from 21 prostatectomy only specimens. We used previously developed genomic signatures to measure the deregulation of oncogenic pathways built using Bayesian Probit models for 'metagene' factors from a singular value decomposition of top differentially expressed genes. A Monte Carlo Markov Chain was used to generate the predicted probabilities of pathway activity in normalized samples. We predicted the activity of these pathways, leading to the generation of probability measures that have previously reflected the state of pathway activity. These probability scores are interpreted as gene expression values to describe pathway activity patterns. A probability near 0 indicates a low chance of pathway activity; a probability near 1 indicates a higher likelihood of activity. Differences (treatment - control) in mean probability for each pathway are reported.|4 years|21 patients had adequate samples for analysis.|||Probability||Standard Deviation|Mean
2779662|NCT00672594|Secondary|Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.|We will perform immunohistochemistry staining on snap frozen specimens for endothelial and pericyte cell staining as previously described (42). Frozen prostate tumor biopsies are sectioned at 6μm thickness and fixed with acetone for 10 minutes. Endogenous peroxidase activity is quenched with 3% hydrogen peroxide for 15 min and then blocked with 5% normal serum. The slides are incubated with the primary antibody (1;100) overnight at 4 C°, and washed with PBS. Negative controls will be included by omission of the primary antibody. Biotinylated donkey antimouse antibody (1:1000, v/v) will be applied for 30 min at room temperature, followed by application of ABC kit (Vector Lab, Inc., Burlingame, USA). Slides are again washed in PBS and the color is developed by 5 min incubation with diaminobenzidine (DAB) solution. Slides are then counterstained with hematoxylin. Mean protein levels are presented.|4 years|Due to changes in the field, this test was not performed due to lack of relevance.||||||
2779663|NCT00672594|Secondary|Change in Systemic Parameters Before and After Sunitinib Malate Treatment.|We evaluated candidate biomarkers of this pathway to predict for pharmacodynamic response to Sunitinib malate. In addition, a 7 ml plasma sample was collected at baseline and again at 4 weeks on all patients to assess possible biomarkers of response. Reported is the mean percent change in plasma concentration for each marker between 4 weeks and baseline.|Baseline and 4 weeks|17 patients had adequate measurements at both time points, were on an adequate dose, and took treatment at the correct time points.|||Percent change||Standard Deviation|Mean
2779664|NCT00672594|Secondary|Change in Pathologic (Microvessel Density).|Pathologic changes will be described using immuno-histochemical techniques (assessment of microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the MVD analysis. Results are reported as the difference in pre and post MVD. Units for MVD are number of CD31 cells per high powered field.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis|||CD31 cells/High Powered Field||Standard Deviation|Mean
2779665|NCT00672594|Secondary|Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity|Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to version 4.0 for the purposes of ClinicalTrials.gov reporting.|4 years||||participants|||Number
2779666|NCT00672594|Primary|Change in Apoptotic Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis|||Percentage of TUNEL positive cells||Standard Deviation|Mean
2779669|NCT00672555|Secondary|Patient Overall Satisfaction With Procedure|Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10.|1 year||||Units on a scale||Standard Deviation|Mean
2779670|NCT00672555|Secondary|Reoperations Needed for Treatment of Complication|"All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year.~All reoperations that were done were assessed and measured."|1year||||Reoperations|||Number
2779671|NCT00672555|Secondary|Minor Complications (Wound Complications)|All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted.|1 year||||participants|||Number
2779672|NCT00672555|Primary|Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure|At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.|1 year|"Per protocol:~All patients treated in the study period, who gave their informed consent and meet the inclusion criteria, as well did not have any reason for exclusion were enrolled prospectively"|||participants|||Number
2779673|NCT00672490|Secondary|Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)|"The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items - Excitement, Hostility and Depression - and 3 supplemental PANSS items related to anger - Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the best and 42 the worst score for the combined scale."|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
2779674|NCT00672490|Secondary|Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42.|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
2779675|NCT00672490|Secondary|Remission Rate (Number of Patients With Clinically Significant Remission)|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission."|From Baseline to 4 weeks||||Participants|||Number
2779676|NCT00672490|Secondary|Response Rate (Number of Patients With Clinically Response)|The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|From Baseline to 4 weeks||||Participants|||Number
2779677|NCT00672490|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
2779678|NCT00672490|Secondary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60.|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
2779679|NCT00672490|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210|Baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2779680|NCT00672490|Secondary|Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)|The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity|Baseline and 4 weeks||||score on a scale||Standard Deviation|Mean
2779681|NCT00672490|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Baseline and 4 weeks|Per Protocol Population|||score on a scale||Standard Deviation|Mean
2779682|NCT00672477|Secondary|Time to First Rescue-free Laxation (Following the First Dose of Study Drug).|"This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A rescue free laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation."|14 days|The analysis population included subjects who received ≥ 1 dose of study drug.|||hours||Inter-Quartile Range|Median
2779683|NCT00672477|Primary|The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses|"This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A rescue free laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation."|7 days|The analysis population included subjects who received ≥ 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2779684|NCT00672451|Secondary|Rate of Decline of GFR||2 years|No data collected||||||
2779685|NCT00672451|Primary|Albumin Concentration in Urine||up to 15 months|Data not collected in all participants of the placebo group.|||mg/dL||Standard Deviation|Mean
2779686|NCT00672438|Secondary|Sedation by Patient Report|"Sedation was assessed by measuring cognitive speed and by asking participants to indicate on a 100-mm visual analog scale (VAS) how sedated they felt. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no sedation was experienced. The other extreme end of the scale represents 100, and 100 represents as much sedation as possible. Participants are asked to indicate what point on that continuum best represents their experience of sedation."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779687|NCT00672438|Secondary|Maximum Drug Disliking|"At the end of an infusion stage participants were asked, What was the maximum that you disliked the drug at any moment (VAS)? (100-mm VAS, 0 _ not at all, 100 _ as much as possible)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the most they disliked the drug experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779688|NCT00672438|Secondary|Maximum Drug Liking|"At the end of an infusion stage participants were asked, What was the maximum that you liked the drug at any moment (VAS)? (100-mm VAS, 0 _ not at all, 100 _ as much as possible)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779689|NCT00672438|Secondary|Average Drug Liking|"At the end of an infusion stage participants were asked, How much did you like the drug on average (100-mm VAS, 0 _ not at all, 100 _ as much as possible)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779690|NCT00672438|Secondary|Maximum Pruritis|"At the end of an infusion stage participants were asked to rate the maximum severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their maximun experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779691|NCT00672438|Secondary|Average Pruritis|"At the end of an infusion stage participants were asked to rate the average severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their average experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779692|NCT00672438|Secondary|Maximum Nausea|"At the end of an infusion stage participants were asked to rate the maximum severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their maximum experience of nausea."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779693|NCT00672438|Secondary|Average Nausea|"At the end of an infusion stage participants were asked to rate the average severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their average experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.|||numerical score||Inter-Quartile Range|Median
2779694|NCT00672438|Secondary|Sedation|Sedative opioid effects were assessed with the trail-making test (TMT) (Angst et al., 2004; Oswald and Roth, 1987). The TMT is a paper-and pencil test consisting of 4 different matrices listing numbers 1-90 in a 9 × 10 format. Subsequent numbers are located in neighboring rows or columns. Matrices were allocated randomly. Subjects had to connect numbers 1-90 as quickly as possible and the time to completion was recorded.|The trail making test was performed at training prior to study procedures, at baseline, and during each of the infusions.|All participants were included for analysis.|||Time in seconds||Inter-Quartile Range|Median
2779695|NCT00672438|Primary|Transcutaneous Partial Pressure of Carbon Dioxide|Partial pressure of transcutaneous carbon dioxide (CO2) was measured with aid of a pO2/pCO2-electrode (Perimed Inc., North Royalton, OH) mounted to the anterior chest wall.|Measured continuously throughout the study session ~ 5 hours|All participants were included for analysis.|||mmHg||Inter-Quartile Range|Median
2779696|NCT00672438|Primary|Respiratory Rate|Breaths per minute counted by direct observation and additionally recorded / external electronic monitoring.|Measured throughout the study session ~ 5 hours|All participants were included for analysis.|||Breaths per minute||Inter-Quartile Range|Median
2779721|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - EGFR vIII|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit.|||participants|||Number
2779697|NCT00672438|Primary|Cold Pain Tolerance|"Time in seconds~Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1-2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to remove their hand from the water bath when it was no longer tolerable - reported as pain tolerance."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.|||Seconds||Inter-Quartile Range|Median
2779698|NCT00672438|Primary|Cold Pain Threshold|"Time in seconds~Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1-2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to indicate the onset of pain - reported as pain threshold."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.|||Seconds||Inter-Quartile Range|Median
2779699|NCT00672438|Primary|Heat Pain Threshold|"Degrees Centigrade~Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin at the volar forearm. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.|||degrees centigrade||Inter-Quartile Range|Median
2779700|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
2779701|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
2779702|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
2779703|NCT00672256|Primary|Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.|||percentage of signal change||Standard Deviation|Mean
2779704|NCT00672243|Secondary|Number of Participants Experiencing a ≥ Grade 3, Treatment-related, Non-hematologic Toxicity.|Number of participants experiencing a ≥ grade 3, treatment-related, non-hematologic toxicity.|2 years|Intent to treat (ITT)|||participants|||Number
2779705|NCT00672243|Secondary|Best Radiographic Response|Best radiographic response per modified Macdonald criteria. Complete response: disappearance of all enhancing tumor, no new lesions, and no steroids or only maintenance doses. Partial response: ≥ 50% reduction in the products of the perpendicular diameters of all enhancing lesions, no new lesions, & steroids must be at a stable/decreasing dose. Stable disease: does not qualify for complete or partial response or progression & is stable clinically. Progression: ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|2 years|Intent to treat (ITT)|||participants|||Number
2779706|NCT00672243|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat (ITT)|||weeks||95% Confidence Interval|Median
2779738|NCT00671788|Secondary|Overall Survival||Every other cycle up to 5 years|Eligible and treated participants|||months||95% Confidence Interval|Median
2781400|NCT00660543|Primary|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).|Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.||||participants|||Number
2779707|NCT00672243|Secondary|Median Progression Free Survival (PFS)|Time in weeks from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|2 years|Intent to treat (ITT)|||weeks||95% Confidence Interval|Median
2779708|NCT00672243|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|Intent to treat (ITT)|||percentage of participants||95% Confidence Interval|Number
2779709|NCT00672204|Primary|The Proportion of Insulin-independent Subjects With Full Islet Graft Function|"Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met:~HbA1c < 7.0% or a ≥2.5% decrease from baseline;~fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period);~2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 21 times in a seven day period);~fasting serum glucose level ≤126 mg/dL (7.0 mmol/L); if the fasting serum glucose level is >126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements;~evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥0.5 ng/mL (0.16 nmol/L)."|1 year following the first islet transplant|Raptiva was removed from market after 3 subjects were transplanted|||participants|||Number
2779710|NCT00672178|Primary|Number of Participants With Overall Complete and Partial Response (CR+PR)||8 weeks|||||||
2779711|NCT00672139|Primary|Number of Laxations Per Subject Within 24 Hours of Dosing Per Week.|This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.|10 weeks|The analysis population included subjects who received study drug and had laxation data and drug administration data. Two subjects in the 12 mg/day group had no drug administration data and were not included in efficacy analyses (but they were included in baseline characteristics and safety analyses).|||Number of laxations||Standard Deviation|Mean
2779712|NCT00672100|Secondary|Functional Outcome - Simple Shoulder Test (SST)|At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2779713|NCT00672100|Secondary|"Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful"|"Participants were asked to rate the helpfulness of their infusion:~extremely harmful~harmful~neutral~not harmful, but not helpful~helpful~extremely helpful"|at 24 and 48 hours after discharge from the hospital||||percentage of participants|||Number
2779714|NCT00672100|Primary|Change in Diaphragmatic Displacement From Baseline to Post-surgery|Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.|Baseline, Post anesthesia care unit (PACU) - within 8 hours||||percent change||95% Confidence Interval|Mean
2779715|NCT00672100|Primary|Pain Measurements Via Numeric Pain Rating Scales (NRS)|Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)|Discharge, 24 h, 48h, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2779716|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - VEGFR-2|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC score is the product of the percentage of cancer cells positive for VEGFR-2 multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year||||IHC Expression Score||Full Range|Median
2779717|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF)|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC expression score is the product of the percentage of cancer cells positive for VEGF multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year||||IHC Expression Score||Full Range|Median
2779718|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Six tumors had an insufficient measurement for analysis.|||participants|||Number
2779719|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Four tumors had an insufficient measurement for analysis.|||participants|||Number
2779720|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis.|||participants|||Number
2779722|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis|||participants|||Number
2779723|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: AUC|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Area under the Curve (ng/mL.h) (AUC) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib|||ng/ml.h||Full Range|Median
2779724|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: Cmax|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Maximum Concentration (ng/mL) (Cmax) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib|||ng/ml||Full Range|Median
2779725|NCT00671970|Secondary|Radiographic Response|"The number of participants with complete or partial response as determined by the following criteria:~Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses.~Partial response (PR): Greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose."|Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participants||||participants|||Number
2779726|NCT00671970|Primary|6 Month Progression-free Survival|The proportion of patients alive and progression free at 6 months|6 months||||proportion of participants||95% Confidence Interval|Number
2779727|NCT00671931|Primary|Motor Evoked Potential Amplitude|The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.|baseline, 30 minutes||||participants|||Number
2779728|NCT00671918|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
2779729|NCT00671918|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/nonlymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
2779730|NCT00671879|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)|Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.|baseline and day +14|Intent to Treat(ITT) population|||marked statements||Standard Error|Least Squares Mean
2779731|NCT00671879|Primary|Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale|on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.|baseline to 14 days|intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo|||mm||Standard Deviation|Least Squares Mean
2779732|NCT00671853|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
2779733|NCT00671853|Secondary|Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
2779734|NCT00671853|Secondary|Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score|"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.~1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
2779735|NCT00671853|Secondary|Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.|Week 0 - Week 8||||Participants|||Number
2779736|NCT00671853|Secondary|Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8||||participants|||Number
2779737|NCT00671853|Primary|Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8||||units on a scale||Standard Deviation|Mean
2779739|NCT00671788|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants|||months||95% Confidence Interval|Median
2779740|NCT00671788|Secondary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||Every cycle during treatment|||||||
2779741|NCT00671788|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
2779742|NCT00671788|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.||||percentage of participants||90% Confidence Interval|Number
2779743|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Burning/Stinging|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
2779744|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
2779745|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
2779746|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)|||participants|||Number
2779747|NCT00671749|Secondary|Global Assessment of Improvement From Baseline||12 weeks||||participants|||Number
2779748|NCT00671749|Secondary|Global Severity Assessment Success|Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear|6 and 12 weeks||||participants|||Number
2779749|NCT00671749|Primary|Percent Change From Baseline in Total Lesion Counts||6 and 12 weeks||||Percent Change||Standard Deviation|Mean
2779750|NCT00671723|Secondary|Rate of Extubation|percentage of patient who were extubated at day 7|7 days||||Participants|||Count of Participants
2779751|NCT00671723|Primary|Change in the Chest X-ray Atelectasis Score|"Each CXR was assigned an atelectasis score.(*) The absence or presence of contralateral hyperinflation was marked as 0 or 1 point, respectively. The absence or presence of mediastinal shift was scored as 0 or 1, respectively. Atelectasis was scored for each lobe. A partial atelectasis of one lobe was scored as one point, whereas complete atelectasis of a lobe was marked as two points. The distinction between infiltrate and atelectasis as well as the total scoring was done by the interpreting radiologist. These results were summed for each CXR. The score range from 0 to 10 with 0 indicates no atelectasis,higher value indicates progressively more atelectasis.~*Hendriks T, de Hoog M, Lequin MH, Devos AS, and Merkus PJ: DNase and atelectasis in non-cystic fibrosis pediatric patients. Crit Care. 2005;9:R351-R356."|Baseline(Day 0) to Day 7||||units on a scale||Standard Deviation|Mean
2779752|NCT00671671|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. Results are reported for Cohort B at Day 3. Due to limited sampling, time interval over which plasma concentrations were measured after final dose was too short relative to projected t1/2. Therefore, t1/2 estimates were not calculated on Day 10.|||hours||Standard Deviation|Mean
2779895|NCT00670046|Secondary|Number of Participants Who Achieve a Partial Response|Partial Response was defined as any participant that showed an increase in PSA doubling time|one year|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent|||Participants|||Count of Participants
2779753|NCT00671671|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||hours||Full Range|Median
2779754|NCT00671671|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||ng/mL||Standard Deviation|Geometric Mean
2779755|NCT00671671|Secondary|Plasma Concentration at The End of Dosing Interval (Ctau)|Ctau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|PP analysis set. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. The Ctau on Day 1 was not necessary for interpretation of the PK data and hence was not analyzed.|||ng/mL||Standard Deviation|Geometric Mean
2779756|NCT00671671|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are reported for Cohort B at Day 3. Due to differences in sampling schedules between Cohort A and B, AUC (0 - ∞) data was not considered meaningful and hence were not analyzed on Day 10 for Cohort A.|||ng*hr/mL||Standard Deviation|Geometric Mean
2779757|NCT00671671|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast). AUClast was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm, respectively. Given the sampling schedule on Day 1 and Day 10 for 450 mg dose in Cohort A, AUClast data was not considered meaningful and hence were not analyzed.|||ng*hr/mL||Standard Deviation|Geometric Mean
2779758|NCT00671671|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. AUCtau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|Per Protocol (PP) analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the pharmacokinetic (PK) parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2779759|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.|||log10 IU/mL||Standard Deviation|Mean
2779760|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.|||log10 IU/mL||Standard Deviation|Mean
2779761|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as the average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.|||log10 IU/mL||Standard Deviation|Mean
2779776|NCT00671437|Secondary|Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)|This was not analyzed due to the lack of evidence-based medicine showing an overall survival benefit of cetuximab monotherapy in this type of cancer.||||||
2790696|NCT00589472|Secondary|Levels of DHT in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/dL||95% Confidence Interval|Median
2779762|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.|||log10 IU/mL||Standard Deviation|Mean
2779763|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Modified Analysis Set (MAS): a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.|||log10 IU/mL||Standard Deviation|Mean
2779764|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (lower limit of quantification [LLOQ] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.|||log10 IU/mL||Standard Deviation|Mean
2779765|NCT00671606|Primary|Sentinel Node Identification Rate|Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.|15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes|Analysis was per protocol; no analysis conducted due to low detection rate.||||Participants||
2779766|NCT00671554|Secondary|Tumor Response Measured by RECIST Criteria and Progression-free Survival.|CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.|From first vaccine to 18 months after the last injection||||participants|||Number
2779767|NCT00671554|Primary|Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.|Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.|From first vaccine to 18 months after the last injection||||participants|||Number
2779768|NCT00671528|Secondary|Number of Days Required to Achieve Total Remission|The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.|Up to 28 days||||Days|||Number
2779769|NCT00671528|Primary|Percent Improvement of Individually Measured Signs of the Disease|"Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator.~The following scale was used:~Cure- Complete remission~> 75% reduction: Marked improvement~50-75% reduction: Moderate improvement~25-50% reduction: Slight improvement~<25% reduction: Ineffectiveness~Worsening of signs & symptoms"|Days 1 (prior to start of treatment), 8, 15, 21, and 28.|Due to lack of participant recruitment and therefore study termination, no analyses were performed.||||||
2779770|NCT00671515|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.|Week 0-Week 12||||units on a scale||Standard Deviation|Mean
2779771|NCT00671515|Primary|Change in Depression Symptom Severity From Baseline to Study Endpoint|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 12||||Units on a scale||Standard Deviation|Mean
2779772|NCT00671502|Secondary|Adverse Event Assessment|the number of adverse events reported during the course of the study as reported by the participants|up to 21 days|||||||
2779773|NCT00671502|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)||up to 14 days|||||||
2779774|NCT00671502|Primary|Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)|the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit|up to 14 days|efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.|||mm||95% Confidence Interval|Least Squares Mean
2779775|NCT00671437|Secondary|Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck||30 days after end of study treatment (approximately 1 year after start of treatment)||||participants|||Number
2779961|NCT00669669|Primary|Number of Participants With Retrovirus or Leukemia|Replication competent retrovirus or diagnosis of leukemia|Up to 2 years after infusion||||Participants|||Count of Participants
2779777|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)|The small dataset precluded an adequate analysis of overall survival relationships due to varying co-variates such as post-progression therapies, ECOG PS, co-morbidities.||||||
2779778|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy|Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT.|Every 8 weeks until disease progression (up to 1 year)||||days||95% Confidence Interval|Median
2779779|NCT00671437|Secondary|Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination||Every 8 weeks until disease progression (up to 1 year)||||participants|||Number
2779780|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|Agreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions.|After 8 weeks of treatment||||participants|||Number
2779781|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|A generalization of McNemar's test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT.|After 8 weeks of treatment||||participants|||Number
2779782|NCT00671437|Secondary|Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan|Definitions of anatomic response by RECIST for CT scan included: complete response(CR)—disappearance of all target and non-target lesions and no new lesions; partial response(PR)—at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)—neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)—at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions.|After 8 weeks of treatment||||participants|||Number
2779783|NCT00671437|Secondary|Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT|Definitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)—complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)—20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)—one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)—not qualifying as CMR, PMR, or PMD.|After 8 weeks of treatment||||participants|||Number
2779784|NCT00671437|Primary|SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab.|"Eight weeks of treatment is equal to one cycle of treatment.~FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response."|Baseline and after 8 weeks of treatment||||SUVmax||95% Confidence Interval|Mean
2779785|NCT00671437|Primary|Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT|FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.|Baseline and after 8 weeks of treatment||||percentage of change||Full Range|Mean
2779786|NCT00671177|Secondary|Patient Satisfaction|Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).|At the time of the procedure||||units on a scale||Full Range|Mean
2779787|NCT00671177|Secondary|Time to Cecum||At the time of the procedure||||minutes||Standard Deviation|Mean
2779788|NCT00671177|Primary|Colonoscopy Success With Minimal Sedation||At the time of the procedure||||Participants|||Count of Participants
2779789|NCT00671060|Primary|Successful Expulsion of Fetus and Placenta Within 48 Hours||48 hours|One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.|||participants|||Number
2779790|NCT00671034|Secondary|Relationship Between PK and Presence of Antibodies|Patients with presence of Antibodies.|Day 29 of consolidation|These data will never be collected.||||||
2779791|NCT00671034|Secondary|Toxicities During Post Induction Intensification Therapy (All Grades)|The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.|Up to 5 years|Patients who had data collected. International normalized ratio (INR). Activated partial thromboplastin (APT)|||Percentage of participants|||Number
2779792|NCT00671034|Secondary|Immunogenicity|Number of Patients with Positive Immunogenicity tests|25 Days Post-dose (Day 29)|Patients who had data collected.|||Participants|||Count of Participants
2779793|NCT00671034|Secondary|Plasma and CSF Concentrations of Asparagine in ug/ml|The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.|25 Days Post-dose (Day 29)|Patients who had data collected.|||ug/mL||Standard Deviation|Mean
2779794|NCT00671034|Secondary|Asparaginase Level|The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar|Days 4, 15, 22 and 29 of Induction|Patients who had data collected.|||percentage of patients||95% Confidence Interval|Number
2779795|NCT00671034|Secondary|Percentage of Participants With Event-free Survival (EFS)|Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.|5 Years||||Percentage of participants||95% Confidence Interval|Number
2779796|NCT00671034|Secondary|Percentage of Participants With Complete Remission at the End of Induction|Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow)|End of induction (Day 29)|Patients who had data collected|||Percentage of participants||95% Confidence Interval|Number
2779797|NCT00671034|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction|Percentage of participants with Negative MRD (MRD<0.01%).|End of induction (Day 29)|Patients who had data collected.|||Percentage of participants||95% Confidence Interval|Number
2779798|NCT00671034|Secondary|Pharmacodynamics (PD)|Plasma Asparaginase Concentration During consolidation and induction.|Day 29 of consolidation and induction|Patients who had data collected|||mIU/mL||Standard Deviation|Median
2779799|NCT00671034|Primary|Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)|Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.|Post Day 29 of Induction and Post Day 22 of Consolidation|Analysis restricted to patients who had PK data collected|||hours||Standard Deviation|Mean
2779800|NCT00670982|Secondary|Progression-free Survival|Median progression free survival measured in months|3 years|Median time from registration to progression of disease|||months||Full Range|Median
2779801|NCT00670982|Secondary|Objective Response Rate|Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), >/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR.|1 year|Confirmed objective response rate|||percentage of participants|||Number
2779802|NCT00670982|Primary|Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.|Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.|1 year|What percentage of patients were still on study and without progression at one year|||percentage of participants||95% Confidence Interval|Number
2779803|NCT00670956|Secondary|Survival at One-month Between Study and Control Groups.|Status of neonate survival 30 days after delivery|30 days after delivery (up to approximately 24 weeks post-enrollment)||||participants|||Number
2779804|NCT00670956|Secondary|Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)||Baseline, Delivery (up to approximately 20 weeks post-enrollment)|Study was terminated without enrollment to control arm; therefore, no comparison was made||||||
2779805|NCT00670956|Primary|Incidence of Hydrops Fetalis||Delivery, up to approximately 20 weeks post-enrollment|Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm|||participants|||Number
2779806|NCT00670930|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy||78 weeks|The safety population consisted of all patients in the intent to treat (ITT) population that received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2779807|NCT00670930|Secondary|Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.|||micrometer(µm)||Standard Deviation|Mean
2779820|NCT00670774|Secondary|Number of Patients Requiring Splenectomy|A splenectomy is a surgical operation involving removal of the spleen. Splenectomy was performed for severe AMR in the setting of a rising serum creatinine (usually >2.0) and a rising serum DSA level despite daily plasma exchange treatments.|1 year|10 subjects discontinued early (<1 year) according to protocol because they had a B flow cytometric crossmatch (BFMX) <200.|||Participants|||Count of Participants
2779808|NCT00670930|Secondary|Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.|||cells/mm^2||Standard Deviation|Mean
2779809|NCT00670930|Secondary|Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.|||cells/mm^2||Standard Deviation|Mean
2779810|NCT00670930|Primary|Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)|The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with both baseline and af end of week 78 data in each category have been reported.|||cells/mm^2||Standard Deviation|Mean
2779811|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Amygdala|"Mu-opioid binding potential in right amygdala measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and 4 months||||ratio||Standard Deviation|Mean
2779812|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Amygdala|"Mu-opioid binding potential in left amygdala measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)"|Baseline and after 4 months||||ratio||Standard Deviation|Mean
2779813|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Nucleus Accumbens|"Mu-opioid binding potential in right nucleus accumbens measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women were included, 2 controls were excluded because repeat baseline HOMA2-IR %S was <80%.|||ratio||Standard Deviation|Mean
2779814|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Nucleus Accumbens|"Mu-opioid binding potential in left nucleus accumbens is measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women completed the protocol and were included. 5 of 7 controls were included in this analysis. 2 controls were excluded from analysis because repeat baseline OGTT showed HOMA %S of <80%.|||ratio||Standard Deviation|Mean
2779815|NCT00670774|Secondary|Transplant Glomerulopathy Incidence at One Year|Transplant glomerulopathy is a morphologic lesion of renal allografts that is characterized histologically by duplication and/or multilayering of the glomerular basement membrane. It is widely accepted as a manifestation of chronic antibody-mediated rejection (AMR). This is determined by histology.|1 year|10 subjects discontinued early (<1 year) according to protocol because they had a B flow cytometric crossmatch (BFMX) <200. An additional subject did not have a biopsy done at one year.|||Participants|||Count of Participants
2779816|NCT00670774|Secondary|Number of Subjects Receiving Posttransplant Plasma Exchange (PE)|Plasma exchange is needed when there is poor kidney functioning, and donor specific alloantibody (DSA) is high|up to one year||||Participants|||Count of Participants
2779817|NCT00670774|Secondary|Number of Subjects With Graft Survival at One Year|Graft survival means the kidney has not been rejected by the body.|1 year|10 subjects discontinued early (<1 year) according to protocol because they had a B flow cytometric crossmatch (BFMX) <200.|||Participants|||Count of Participants
2779818|NCT00670774|Secondary|Length of Follow-up|Following the completion of dosing, subjects were to return for follow-up visits at 3 and 6 months post transplant to obtain biopsies and collect follow-up data. Subjects who continued the drug for 12 months were to receive their final assessment at 15 months.|up to 15 months||||months||Standard Deviation|Mean
2779819|NCT00670774|Secondary|Graft Dysfunction in First Month Post Transplant|(Maximum serum creatinine-nadir serum creatinine)|1 month||||mg/dL||Standard Deviation|Mean
2779821|NCT00670774|Secondary|Number of Patients Developing High DSA Levels at Less Than or Equal to 3 Months|High DSA levels were defined as B flow cross match channel shift >350 at any time point in the first 3 months.|3 months||||Participants|||Count of Participants
2779822|NCT00670774|Primary|Number of Subjects With Antibody-Mediated Rejection (AMR) in the First 3 Months After Living Donor Kidney Transplantation|AMR can cause acute graft loss or shorten allograft survival. Renal allograft biopsies were obtained percutaneously using ultrasound guidance processed for light microscopy and immunofluorescence for peritubular capillary staining for C4d. All biopsies were reviewed by a pathologist in a blinded fashion. AMR was diagnosed using standard Banff criteria in combination with graft dysfunction (increase in serum creatinine >/=0.3 mg/dL over nadir.)|up to 3 months||||Participants|||Count of Participants
2779823|NCT00670748|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately, 66 months and 10 days||||Participants|||Count of Participants
2779824|NCT00670748|Secondary|Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month post treatment||||Participants|||Count of Participants
2779825|NCT00670748|Primary|Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 3 years||||Participants|||Count of Participants
2779826|NCT00670709|Primary|Quantitative Electroencephalography Absolute Alpha Power.|Absolute power in the alpha frequency as measured by quantitative electroencephalography|baseline EEG||||microvolts squared||Standard Deviation|Mean
2779827|NCT00670709|Primary|Quantitative Electroencephalography Absolute Delta Power.|Absolute power in the delta frequency as measured by quantitative electroencephalography|baseline- one time point||||microvolts squared||Standard Deviation|Mean
2779828|NCT00670631|Secondary|Overall Survival Will be Compared to a Historical Control (UARK 98-026, TT2)as a Secondary Outcome.||After 204 patients have been enrolled|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.||||||
2779829|NCT00670631|Primary|In Assessing Patient Safety, we Will Examine Treatment Toxicity Related Mortality and SAEs. Historical Study Results Indicate That a Mortality Rate of Greater Than 10% is Not Acceptable in This Population, Nor is an SAE Rate of Greater Than 15%.||Interim analyses for safety will be performed after 20, 100, 200, and 300 patients have been enrolled.|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.||||||
2779830|NCT00670631|Primary|To Determine Whether, in Comparison to TT II, the Median EFS Can be Increased From 4.8 Years to 6.2 Years, Which Represents an Increase in Median EFS of Approximately 30%||After enrollment of 204 subjects is completed|Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.||||||
2779831|NCT00670540|Secondary|Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)||at 3 years||||percentage of participants||95% Confidence Interval|Number
2779832|NCT00670540|Secondary|Percentage of Participants Who Developed Cancer Onset||at 3 years||||percentage of participants||95% Confidence Interval|Number
2779833|NCT00670540|Secondary|Percentage of Participants Who Died From Any Cause||at 3 years||||percentage of participants||95% Confidence Interval|Number
2779834|NCT00670540|Secondary|Percentage of Participants Who Developed Cardiovascular Events||at 3 years||||percentage of participants||95% Confidence Interval|Number
2779835|NCT00670540|Secondary|Percentage of Participants With Treatment Anticoagulant Prescribed||after inclusion||||percentage of participants||95% Confidence Interval|Number
2779836|NCT00670540|Secondary|Percentage of Participants Who Developed Major Bleeding Events||at 3 years||||percentage of participants||95% Confidence Interval|Number
2779837|NCT00670540|Primary|Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)|new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.|at 3 years||||percentage of participants||95% Confidence Interval|Number
2779838|NCT00670488|Secondary|Number of Participants With Confirmed Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)|Overall tumor response was assessed during the study by diagnostic anatomic imaging using RECIST. The number of participants with a confirmed Complete Response (CR: Disappearance of all target lesions) as per RECIST was reported for each dose level group.|From Cycle 1 Day 1 through the End of Study Visit (up to 6 months)|All participants with measurable disease at baseline per RECIST.|||Participants|||Count of Participants
2779879|NCT00670267|Secondary|Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)|Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).|Baseline to end of study (105 days)|Analysis excludes one early termination subject|||mg/mL||Standard Deviation|Mean
2779839|NCT00670488|Secondary|Phosphorylated Protein Kinase B (pAkt) Level on Cycle 1 Day 15 (C1D15) After Treatment With MK-2206 at the Maximum Tolerated Dose (MTD)|To determine the inhibition of pAkt by MK-2206 in participants treated at the MTD, levels of Akt phosphorylated at the serine 473 residue (pAkt Ser473 Akt) were measured in snap-frozen tumors collected at baseline and Day 15 of Cycle 1 using a MesoScale enzyme-linked immunosorbent assay (ELISA). Per protocol, pAkt levels were determined only for the MK-2206 MTD (60 mg QOD) group.|Baseline, Cycle 1 Day 15|Participants treated at the MTD (60 mg QOD) dose level with measurable disease at baseline per RECIST and paired tumor samples at baseline and C1D15. Per protocol, no other dose level groups were analyzed.|||pAkt lysate units/mg protein||95% Confidence Interval|Geometric Mean
2779840|NCT00670488|Primary|t½ of MK-2206 in Participants Receiving Multiple QW Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. t½ (Harmonic mean ± pseudo SD) was calculated for the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).|Day 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing|All participants who received MK-2206 orally QW on Day 22 of Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.|||hour||Standard Deviation|Mean
2779841|NCT00670488|Primary|Tmax of MK-2206 in Participants Receiving Multiple QW Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Tmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).|Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing|All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.|||hour||Full Range|Median
2779842|NCT00670488|Primary|C48hr of MK-2206 in Participants Receiving Multiple QW Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. C48hr was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).|Days 1 and 22: predose and 48 hours after MK-2206 dosing|All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.|||nM||Standard Deviation|Mean
2779843|NCT00670488|Primary|Cmax of MK-2206 in Participants Receiving Multiple QW Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Cmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).|Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing|All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.|||nM||Standard Deviation|Mean
2779844|NCT00670488|Primary|AUC0-168hr in Participants Receiving Multiple QW Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. AUC 0-168 was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).|Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing|All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.|||nM•hr||Standard Deviation|Mean
2779845|NCT00670488|Primary|Apparent Terminal Half-life (t½) of MK-2206 in Participants Receiving Multiple QOD Dosing|Blood samples were collected for PK analyses on Day 27 of the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. t½ (Harmonic mean ± pseudo SD) was calculated and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).|Day 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing.|All participants who received MK-2206 orally QOD on Day 27 of Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.|||hour||Standard Deviation|Mean
2779846|NCT00670488|Primary|Time to Maximum Concentration (Tmax) of MK-2206 in Participants Receiving Multiple QOD Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Tmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).|Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing|All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.|||hour||Full Range|Median
2779847|NCT00670488|Primary|Concentration of MK-2206 After 48 Hours (C48hr) in Participants Receiving Multiple QOD Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. C48hr was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).|Days 1 and 27: predose and 48 hours after MK-2206 dosing.|All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.|||nM||Standard Deviation|Mean
2779848|NCT00670488|Primary|Maximum Concentration (Cmax) of MK-2206 in Participants Receiving Multiple QOD Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Cmax was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).|Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing|All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.|||nM||Standard Deviation|Mean
2779849|NCT00670488|Primary|Area Under the Concentration-time Curve of MK-2206 From Time 0 to 48 Hours (AUC0-48hr) in Participants Receiving Multiple QOD Dosing|Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. AUC 0-48hr was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).|Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing|All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.|||nM•hr||Standard Deviation|Mean
2779850|NCT00670488|Primary|Number of Participants With One or More Adverse Events (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the SPONSOR's product, was also an AE. The number of participants that experienced one or more AEs was reported for each dose level group.|Up to 269 days|APaT population: All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2779851|NCT00670488|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was any drug-related AE, regardless of grade, leading to a dose modification of MK-2206. Dose-limiting hematologic and nonhematologic toxicities were defined differently and were based on events occurring during the first cycle of study drug administration. Hematologic DLT defined as any Grade (Gr) 4 or greater hematologic toxicity except neutropenia described as follows: Neutropenia that was Gr 4 lasting for ≥7 days, or Gr 3/Gr 4 with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment considered DLT. Gr 4 thrombocytopenia (≤25.0 x 10^9/L) was also considered DLT. Non-hematologic DLTs were defined as any Gr 3, 4, or 5 nonhematologic toxicity, with the specific exceptions of: Gr 3 nausea, vomiting, diarrhea, or dehydration occurring with inadequate supportive care and lasting <48 hours; alopecia; inadequately treated hypersensitivity reactions; and Gr 3 elevated transaminases of ≤1 week in duration. A participant could have more than one DLT.|Day 1 to Day 28 (Cycle 1)|The All Participants as Treated (APaT) population: All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2779852|NCT00670462|Secondary|Waist-to-hip Ratio at 30 Months||30 months||||ratio||Standard Error|Mean
2779853|NCT00670462|Secondary|Waist-to-hip Ratio at 18 Months||18 months||||ratio||Standard Error|Mean
2779854|NCT00670462|Secondary|Waist-to-hip Ratio at 12 Months||12 months||||ratio||Standard Error|Mean
2779855|NCT00670462|Secondary|Waist-to-hip Ratio at 6 Months||6 months||||ratio||Standard Error|Mean
2779856|NCT00670462|Secondary|Change From Baseline in Energy Intake at 18 Months||18 months||||kcal/day||Standard Error|Mean
2779857|NCT00670462|Secondary|Change From Baseline in Energy Intake at 12months||12 months||||kcal/day||Standard Error|Mean
2779858|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 18 months|18 months||||kcal/wk||Standard Error|Mean
2779859|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 12 months|12 months||||kcal/wk||Standard Error|Mean
2779860|NCT00670462|Secondary|Mood State||baseline, 6, 12, 18, and 30 months|||||||
2779861|NCT00670462|Secondary|Triglycerides||baseline, 6, 12, 18, and 30 months|||||||
2779862|NCT00670462|Secondary|HDL||baseline, 6, 12, 18, and 30 months|||||||
2779863|NCT00670462|Secondary|Insulin||baseline, 6, 12, 18, and 30 months|||||||
2779864|NCT00670462|Secondary|Blood Glucose||baseline, 6, 12, 18, and 30 months|||||||
2779865|NCT00670462|Secondary|Waist-to-hip Ratio at Baseline||baseline||||ratio||Standard Error|Mean
2779866|NCT00670462|Secondary|Blood Pressure||baseline, 6, 12, 18, and 30 months|||||||
2779867|NCT00670462|Secondary|Change From Baseline in Energy Intake at 6 Months||Baseline and 6 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."|||kcal/day||Standard Error|Mean
2779868|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 6 months|Baseline and 6 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."|||kcal/wk||Standard Error|Mean
2779869|NCT00670462|Primary|Change in Body Weight||Baseline to18 months|"Waist-to-hip Ratio was assessed for all Males and Females, separately, irrespective of the intervention to which participants were randomized."|||kg||Standard Deviation|Mean
2779877|NCT00670267|Secondary|Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline|In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline to end of study (105 days)||||units on a scale||Standard Deviation|Mean
2779870|NCT00670449|Secondary|Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. • The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Units on a scale||Standard Deviation|Mean
2779871|NCT00670449|Secondary|Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Percentage of patients||95% Confidence Interval|Number
2779872|NCT00670449|Secondary|Percentage of Patients Relapse-free at the End of the Study|Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010).(approximately 22 months before study completion)|||Percentage of patients||95% Confidence Interval|Number
2779873|NCT00670449|Secondary|Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses|The ARR was defined as the total number of relapses for all patients in the treatment arm / total number of days in the study for all patients in the treatment arm for the specific period of time × 365.25. General definition of relapse: Appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (< 37.5°C) or infection. A relapse was to be confirmed by a neurologist trained on the Expanded Disability Status Scale (EDSS). A relapse must be accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on 2 different Functional Systems (FS) of the EDSS or 2 points on 1 of the FS (excluding Bowel/Bladder or Cerebral FS).|Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Relapses per year|||Number
2779874|NCT00670449|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of new or newly enlarged T2 weighted MRI lesions were counted and recorded. New lesions were identified by comparing each lesion with previous scans. Lesions expanding through several slices were counted as only 1 lesion.|Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set(FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. Study became open-label with all patients receiving FTY720 0.5 mg/day. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb-2010). (approximately 22 months before study completion)|||Percentage of patients|||Number
2779875|NCT00670449|Primary|Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.|Months 6, 9, 12, 18, 24, 36, and 48|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)|||Percentage of patients|||Number
2779876|NCT00670306|Primary|IPSS Change From Baseline|International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26|Baseline and Week 26|Intention to treat (ITT) analysis with Last Observation Carried Forward (LOCF) imputation technique|||Units on a scale||Standard Deviation|Mean
2779878|NCT00670267|Secondary|Percent Change in FEV1% Predicted From Baseline to End of Study||Baseline to end of study (105 days)||||percent change in FEV1% predicted||Standard Deviation|Mean
2779880|NCT00670267|Primary|Daily Dose at Study Termination Across Participants|The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.|Baseline to end of study (105 days)||||participants|||Number
2779881|NCT00670267|Primary|Mean Daily Dose at Study Termination Across Participants|The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.|Baseline to end of study (105 days)||||mg||Standard Deviation|Mean
2779882|NCT00670241|Secondary|Subjects With Rebound During the Study||Week 8-16||||participants|||Number
2779883|NCT00670241|Secondary|Subjects With Relapse During the Study|Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit|Week 8-16||||participants|||Number
2779884|NCT00670241|Secondary|The Percentage Change in PASI From Baseline to Week 8|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).|Baseline, Week 4 and 8||||Percent change in PASI score|||Number
2779885|NCT00670241|Secondary|"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"||Week 4||||participants|||Number
2779886|NCT00670241|Primary|"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"||Week 8||||Participants|||Number
2779887|NCT00670228|Secondary|Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)||At Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.|||mg/L||Standard Deviation|Mean
2779888|NCT00670228|Secondary|Occurrence of the Major Adverse Cardiovascular Events (MACE)|"MACE:~Cardiac death, New onset or worsening congestive heart failure (>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation"|At Day 60|Analysis was performed on the safety population which includes all subjects who received any study treatment. All subjects in this population were analyzed according to the actual treatment they received.|||events|||Number
2779889|NCT00670228|Secondary|Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)|Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned.|At Day 3|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.|||percentage of Ejection Fraction||Standard Deviation|Mean
2779890|NCT00670228|Primary|Infarct Size Absolute Change From Baseline at Day 60|Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.|From baseline at Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.|||percentage of LV mass change||Standard Deviation|Mean
2779891|NCT00670202|Primary|Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.|We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.|>= 2 weeks|||||||
2779892|NCT00670111|Secondary|Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.|"Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were RAP On for months 1 through 6. All participants were 'Rap On' for months 6 to 12."|6 months post implant|"The following were required for a patient's dataset to be included in the analysis:~2 CPX tests had to be performed (1M with RAP Off, 6M with RAP On [RAP was On from 1M to 6M]),~Each CPX test had to result in RER ≥ 1.05,~Trending data from the disk had to have been obtained during each CPX test."|||ml/kg/min||Standard Deviation|Mean
2779893|NCT00670111|Primary|Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.|Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.|1 month post implant|"The following were required for a patient's dataset to be included in the analysis:~2 CPX tests had to be performed at 1M (RAP On & RAP Off),~Each 1M CPX test had to result in RER ≥ 1.05,~Trending data from the disk had to have been obtained during each 1M CPX test."|||ml/kg/min||Standard Deviation|Mean
2779894|NCT00670046|Secondary|Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score|"Study questionnaire, known as Functional Assessment of Cancer Therapy - Prostate (FACT-P), were given to participant to complete during study participation. FACT-P is a validated tool to assess self-perceived functionality, psychosocial well-being, and quality of life; and the scoring of the questionnaire was based on the technique published by FACIT (Functional Assessment of Chronic Illness Therapy). The FACT-P is a 39-item questionnaire, with each item being scored from on a Likert scale of 0-4. The total score ranges from 0-156, with a higher score reflecting a better outcome."|at time of enrollment, mid-study, end of study (up to 1 year)|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent; Average FACT-P scores for both arms at Study enrollment, mid study and at end of study is being reported.|||units on a scale||Standard Deviation|Mean
2779896|NCT00670046|Secondary|Number of Participants Who Achieve a Complete Response|Complete response was defined as PSA Doubling Time increasing to greater than 10 months. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. The > 10 month criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper.|one year|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent|||Participants|||Count of Participants
2779897|NCT00670046|Secondary|Duration of PSA Response as Assessed by PSA Doubling Time (PSADT)|Serum PSA was measured once a month, each month for the one year the subjects were on the protocol. PSA Doubling time is defined as the duration for PSA levels in the blood to increase by 100 percent, and is calculated based on the rate of change in serum PSA values. Prostate-specific antigen doubling time (PSADT) was calculated by natural log of 2 (0.693) divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient (Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697), therefore it can be much greater than the 12 months that we followed the patients for. PSADT was calculated for pre enrollment, at the mid point of the study & at the end of study.|pre-study, mid-study, end of study (up to 1 year)|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent.|||months||Standard Deviation|Mean
2779898|NCT00670046|Primary|Number of Participants Exhibiting an Increase in Observed or Predicted Prostate-specific Antigen (PSA) Doubling Time|Number of participants exhibiting an increase in observed or predicted prostate-specific antigen (PSA) doubling time after initiation of the study. Blood was drawn monthly during study period (1 year), serum PSA was measured & PSADT calculated. A doubling time of > 10 month is defined as complete response (3. Secondary Outcome) and this criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. Any increase in PSADT is defined as partial response (4. Secondary Outcome).|1 year|One participant from Arm 1 was lost to follow-up; One participant from Arm II was lost to follow-up and another withdrew consent|||Participants|||Count of Participants
2779899|NCT00670007|Secondary|Percentage of Subjects With Treatment Emergent Adverse Events|Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration.|From baseline up to 2.5 years|Safety population comprises all subjects who were included in the study and who received at least 1 dose of Zemaira during study CE1226_3001.|||percentage of subjects|||Number
2779900|NCT00670007|Secondary|Time to First Pulmonary Exacerbation||Up to 2 years|ITT population.|||years||95% Confidence Interval|Median
2779901|NCT00670007|Secondary|Annual Rate in Subject Years of Pulmonary Exacerbations|Annual exposure‑adjusted incidence rate of pulmonary exacerbations.|Up to 2 years|ITT population.|||Exacerbations/subject year||95% Confidence Interval|Number
2779902|NCT00670007|Secondary|Number of Subjects With Pulmonary Exacerbations||Up to 2 years|ITT population.|||participants|||Number
2779903|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Percent Predicted FEV1||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
2779904|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
2779905|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
2779906|NCT00670007|Secondary|Change in Subject-reported Symptoms|Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||units on a scale (change from baseline)||Standard Deviation|Mean
2779907|NCT00670007|Secondary|Percent Change in Adjusted Lung Density|Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||Percent change from baseline||Standard Deviation|Mean
2779908|NCT00670007|Secondary|Absolute Change in Adjusted Lung Density|Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||g/L||Standard Error|Least Squares Mean
2779909|NCT00670007|Primary|Rate of Change of Adjusted Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients.|Up to 2 years|Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.|||g/L per year||Standard Error|Least Squares Mean
2779910|NCT00669955|Secondary|Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level|Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)|Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only|Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.|||participants|||Number
2779911|NCT00669955|Secondary|Overall Compliance to Study Medications|Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population|At the end of the treatment phase (days 8-14)|Safety population.|||participants||Standard Deviation|Mean
2779912|NCT00669955|Secondary|Metronidazole Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml|Measured at baseline|Per protocol population|||participants|||Number
2779913|NCT00669955|Secondary|Clarithromycin Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above|Measured at baseline|Per protocol analysis population|||participants|||Number
2779914|NCT00669955|Secondary|H. Pylori Eradication and Presence or Past History of Peptic Ulcers|Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.|Week 6 and week 10 follow-up visits|Per protocol population.|||Participants|||Number
2779915|NCT00669955|Secondary|Number of Patients Experiencing Treatment Emergent Adverse Events.|"A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.~All safety analysis based on the safety population."|at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.|Safety population, described as all randomized patients having received at least one dose of study medication|||Participants|||Number
2779916|NCT00669955|Primary|Helicobacter Pylori Eradication Confirmed by Urea Breath Test|H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.|Week 6 and week 10 follow-up visits|No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.|||Participants|||Number
2779917|NCT00669942|Secondary|Disease Activity Score (DAS28) of Parts 2 and 3 Participants|The DAS28 is a composite score based on tender and swollen joint counts, C reactive protein (CRP) concentrations, and the participant's global disease activity based on a visual analogue scale (VAS). The tender joint count (based on 28 joints) was calculated by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. The information on various types of tenderness was then collapsed into a single tender versus non-tender dichotomy, and the number of joints that were classified as tender was recorded. The swollen joint count was calculated in the same manner. For CRP concentrations, blood samples were collected and sent to a central laboratory for assessment. For the VAS assessment, the participant used a 100 mm horizontal VAS to assess the severity of his or her arthritis where 0 = none and 100 = most severe. DAS28 scores range from <2.6 (disease remission) to >5.1 (high disease activity).|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.|||scores on a scale||Standard Error|Mean
2779918|NCT00669942|Secondary|Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70|Clinical response to treatment was assessed according to ACR50 and ACR70 criteria. A participant was defined as an ACR50 or ACR70 responder if the following 3 conditions were met: 1) improvement of ≥50% or ≥ 70%, respectively, in the number of tender joints, 2) improvement of ≥50% or ≥ 70%, respectively, in the number of swollen joints and 3) improvement of ≥50% or ≥ 70%, respectively, in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.|||Percentage of participants|||Number
2779919|NCT00669942|Primary|Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||Day||Standard Deviation|Mean
2779920|NCT00669942|Primary|Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||Liters/day||Standard Deviation|Mean
2779921|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||Liter||Standard Deviation|Mean
2779922|NCT00669942|Primary|Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||day*ug/mL||Standard Deviation|Mean
2779962|NCT00669669|Primary|Number of Participants Dose-limiting Toxicity (DLT)|Defined as any grade 4 nonhematopoietic toxicity that is likely related to the investigational procedures (Part I)|Up to 6 weeks after infusion||||Participants|||Count of Participants
2779923|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||ug/mL||Standard Error|Mean
2779924|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||day||Full Range|Median
2779925|NCT00669942|Primary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.|||day||Standard Deviation|Mean
2779926|NCT00669942|Primary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||Liters/day||Standard Deviation|Mean
2779927|NCT00669942|Primary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||Liters||Standard Deviation|Mean
2779928|NCT00669942|Primary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||day*ug/mL||Standard Deviation|Mean
2779929|NCT00669942|Primary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||ug/mL||Standard Deviation|Mean
2779930|NCT00669942|Primary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 29, 36, 43, 57, 71, 85, 99 and 113.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.|||day||Full Range|Median
2779931|NCT00669942|Primary|Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20)|Clinical response to treatment was assessed according to ACR20 criteria. A participant was defined as an ACR20 responder if the following 3 conditions were met: 1) ≥20% improvement in the number of tender joints, 2) ≥20% improvement in the number of swollen joint and 3) ≥20% improvement in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant.|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.|||percentage of participants|||Number
2779932|NCT00669916|Secondary|Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants|||day||Standard Deviation|Mean
2779933|NCT00669916|Primary|Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score|The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement.|Baseline, Week 4|All participants|||Percentage of participants|||Number
2779934|NCT00669916|Secondary|Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||Liters/day||Standard Deviation|Mean
2779935|NCT00669916|Secondary|Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||Liters||Standard Error|Mean
2779936|NCT00669916|Secondary|Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants|||day*ug/mL||Standard Deviation|Mean
2779937|NCT00669916|Secondary|Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||ug/mL||Standard Deviation|Mean
2779938|NCT00669916|Secondary|Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.|||days||Full Range|Median
2779939|NCT00669916|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.|Baseline, Week 4|All participants|||Percentage change in PASI mean score|||Number
2779940|NCT00669903|Secondary|CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14|GMRT score defined as the -log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate|Baseline and Day 14||||unit on a scale||Standard Error|Least Squares Mean
2779941|NCT00669903|Secondary|CogState Identification Task (IT) Standardized Change Score at Day 14|IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate|Baseline and Day 14||||unit on a scale||Standard Error|Least Squares Mean
2779942|NCT00669903|Secondary|CogState Detection Task (DT) Standardized Change Score at Day 14|DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
2779943|NCT00669903|Secondary|CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14|OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
2779944|NCT00669903|Secondary|CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14|GMLT score is defined as the -log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
2779993|NCT00669331|Secondary|Sputum Volume|24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52|52 weeks||||g||Standard Deviation|Mean
2780201|NCT00667563|Primary|Number of Patients With a Significant Increase in HIV Viral Load|Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions|Screening/week 0, weeks, 2, 10, 26 and 52||||participants|||Number
2779945|NCT00669903|Primary|CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14|The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14||||units on a scale||Standard Error|Least Squares Mean
2779946|NCT00669877|Other Pre-specified|Overall Response Rate: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR)|Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR.|After two 21-day courses, response to treatment checked for Complete Remission (CR)|Of fifty-six registered, nine participants entered the study with CR therefore were not evaluable for response.|||percentage of participants|||Number
2779947|NCT00669877|Primary|Complete Remission Rate: Percentage of Participants With Complete Remission (CR)|Complete Remission (CR) was defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count ≥1.0 × 10^9/L, a platelet count ≥100 × 10^9/L, and no extramedullary disease. Complete recovery except platelets (CRp) was defined as for CR, except for recovery of platelet count to <100 × 10^9/L. Partial remission (PR) was defined as a bone marrow with >5% and <25% blasts with a granulocyte count of ≥1.0 × 109/L and a platelet count of ≥100 × 10^9/L. Relapse was defined by recurrence of more than 5% lymphoblasts in the bone marrow aspirate or by the presence of extramedullary disease after achieving CR.|After two 21-day courses, response to treatment checked for Complete Remission (CR)|Of fifty-six registered, nine participants entered the study with CR therefore were not evaluable for response.|||percentage of participants|||Number
2779948|NCT00669864|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||episodes|||Number
2779949|NCT00669864|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||episodes|||Number
2779950|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage of participants|||Number
2779951|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Less Than 7.0%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage of participants|||Number
2779952|NCT00669864|Secondary|Change in 8-point Plasma Glucose Profile|Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mg/dL||Standard Error|Mean
2779953|NCT00669864|Primary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage (%) of total haemoglobin||Standard Error|Mean
2779954|NCT00669682|Primary|Number of Positive Twave Studies and Concurrent Positive Optivol Measurement|We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.|upto 3 years||||participants|||Number
2779955|NCT00669669|Secondary|Number of Participants With Chemoprotection|assessed by the ability to increase the Temozolomide dose beyond 472 mg/m^2|Up to 15 years||2027-12-31|12/2027||||
2779956|NCT00669669|Secondary|Gene Transfer Efficiency and in Vivo Selection|Assessed by gene marking in peripheral blood and marrow|Up to 15 years||2027-12-31|12/2027||||
2779957|NCT00669669|Secondary|Time to Progression|From the first day of treatment until unequivocal progression is documented, assessed up to 15 years|Up to 15 years||2027-12-31|12/2027||||
2779958|NCT00669669|Secondary|Number of Participants That Survived|From the first day of treatment until death, assessed up to 15 years|Up to 15 years||2027-12-31|12/2027||||
2779959|NCT00669669|Secondary|Duration of Response|From the onset of temozolomide to the date at which unequivocal disease progression, assessed up to 15 years|Up to 15 years||2027-12-31|12/2027||||
2779960|NCT00669669|Secondary|Response Rate|Proportion of patients with reduction in tumor burden of a predefined amount|Up to 15 years||2027-12-31|12/2027||||
2779963|NCT00669617|Primary|Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose|FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.|Five Minutes Post Dose|Modified Intent-to-Treat (mITT) population: including all randomized patients who received at least one dose of study drug. If any of the values used in the period baseline FEV1 and FEV1 at 5 min post-dose were collected within 6 hours of rescue medication, then the individual FEV1 value was set to missing.|||Liters||Standard Error|Least Squares Mean
2779964|NCT00669578|Primary|Best Overall Response Over the First 6 Cycles of Treatment|"Response evaluation:~Complete Remission (CR):~Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow.~Partial Hematologic Response/Partial Remission (PR):~Increase in neutrophil by 50% + above 10^9/L for neutropenia)~Clinical Improvement (CI):~Increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts."|Every cycle of treatment for 6 cycles. Each cycle is 28 days.|None of the participants from the Phase I cohort were analyzed for this endpoint. All 65 Phase II participants were evaluable for this endpoint and included in the analysis.|||participants|||Number
2779965|NCT00669578|Secondary|Time to Response|The time to response is defined as the time from study registration to the first date at which the patient's objective status was classified as a response (CR, PR or CI). In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. The distribution for each of these event-time variables (duration of response and time to response) will be estimated by Kaplan-Meier curves.|Time from registration to the first date of response within twelve 28-day cycles of treatment.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) patients were recruited for the Phase II portion. Only 9 of the 65 patients achieved a response. Thus, the median of time to response and the upper limit of 95% confidence interval are not attainable.||||||
2779966|NCT00669578|Secondary|Duration of Response Time|Duration of response is defined as the date at which the patient's objective status is first noted to be a CR, PR or CI to the date progression is documented (if one has occurred) or to the date of last follow-up(for those patients who have not progressed).|Time from response to disease progression, intolerance of study drug, or death.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) participants were recruited for the Phase II portion. Results presented here are on the 9 Phase II patients who responded to treatment.|||Months||95% Confidence Interval|Median
2779967|NCT00669578|Secondary|Number of Participants With Treatment Related Adverse Events.|Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. The number of participants with grade 3 or higher adverse events at least possibly related to study treatment are reported here.|During treatment and every 6 months until 3 years from registration or progression.|None of the Phase I participants were used for this primary endpoint. All 65 Phase II participants were evaluable for this endpoint.|||participants|||Number
2779968|NCT00669578|Primary|Determine the Maximum Tolerated Dose of CC-4047|Starting at a dose level of 2.5 mg/d on days 1-21 in every 28 day cycle, participants were accrued in cohorts of three to assess dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD). Dose escalation at increments of 0.5 mg/d was done if no subject had a DLT (a grade 4 or higher hematologic toxicity or a grade 3 or higher febrile neutropenia or a grade 3 or higher non-hematologic toxicity) in cycle 1. Subsequent cohorts were treated until the maximum tolerated dose (MTD) was reached (dose level before that which results in a DLT in >1 of 6 subjects). Subsequent participants were treated at the MTD, those without response at the MTD after 3 cycles were lowered to the minimal efficacious dose (MED) of 0.5 mg daily. Here, we are reporting the percentage of participants in Phase I with a DLT at each dose level.|The first 28-day cycle of treatment.|None of the Phase II participants were evaluable for this endpoint. For the Phase I portion of this study, three participants were accrued at a 2.5 mg/day dose level, six at the 3.0 mg/day dose level, and three at the 3.5 mg/day dose level.|||percentage of participants with DLT|||Number
2779969|NCT00669552|Primary|Number of Subjects With Positive T Wave Studies During a Coronary Intervention|Positive T wave alternans is determined by a proprietary program using ECG recordings during a stress test. The result is reported as positive, negative, or indeterminate.|During the coronary intervention, upto 2 hours|Only collected on subjects that had an intervention|||participants|||Number
2779970|NCT00669539|Primary|Mean Amblyopic Eye Visual Acuity Improvement With Spectacles|Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.|Enrollment to 18 Weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.|||logMAR units||Standard Deviation|Mean
2779971|NCT00669461|Secondary|Average Number of Spontaneous Bowel Movements (SBM) Per Week|Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient.||||||
2779994|NCT00669331|Secondary|Duration of Graded Exacerbations|Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable|52 weeks|Randomised and treated|||Days with GPE||95% Confidence Interval|Mean
2780202|NCT00667563|Primary|Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28|Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline|Week 28|Per-protocol population with undetectable HPV-16 levels at baseline|||participants|||Number
2779972|NCT00669461|Primary|Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks|The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient)||||||
2779973|NCT00669396|Secondary|IUD Expulsion, Removal, or Perforation|patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.|6 months||||participants|||Number
2779974|NCT00669396|Secondary|Infection|diagnosis and treatment for pelvic inflammatory disease|6 months||||participants|||Number
2779975|NCT00669396|Secondary|Pregnancy|positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.|6 months||||participants|||Number
2779976|NCT00669396|Primary|Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception|Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.|6 months||||participants|||Number
2779977|NCT00669383|Secondary|FiO2||During initial hospital stay and planned follow-up|Number of participants is greater here as it includes all offspring, including twins.|||Participants|||Count of Participants
2779978|NCT00669383|Primary|Measurements of Respiratory Compliance (Crs) in Preterm Infants.||Within first 72 hours after birth|Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.|||mL/cm H2O/kg||Standard Deviation|Mean
2779979|NCT00669383|Primary|Measurements of Functional Residual Capacity in Preterm Infants.||Within first 72 hours after birth|Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.|||mL/kg||Standard Deviation|Mean
2779980|NCT00669331|Other Pre-specified|Cost Effectiveness of Treating Patients With Bronchiectasis With Inhaled Mannitol|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, cost effectiveness was not collected).|52 weeks|Not collected. As the primary objective of this study did not reach statistical significance, cost effectiveness data were not collected.||||||
2779981|NCT00669331|Other Pre-specified|Health Related Quality of Life (HRQL) and Quality Adjusted Life Years (QALYs) by Treatment Group Using Utility Scores From the Health Utilities Index Questionnaire|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, HRQL and QALYs were not collected).|52 weeks|No data were collected for this assessment. As the primary objective of this study did not reach statistical significance, HRQL and QALYs were not derived.||||||
2779982|NCT00669331|Other Pre-specified|Health Status and Utility Scores|In the presence of a significant primary endpoint, these data were intended to be derived from the trial data and external information (Note as the primary objective of this study did not reach statistical significance, differences in health status and utility scores were not assessed)|52 weeks|No data were collected. As the primary objective of this study did not reach statistical significance, health status and utility scores were not derived.||||||
2779983|NCT00669331|Other Pre-specified|Health Related Costs of Treating Patients With Bronchiectasis|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data together with external information (Note as the primary objective of this study did not reach statistical significance, health related costs were not assessed)|52 weeks|No data were collected. Since the primary objective was not significant in this study, further exploration of health economic endpoints was not done.||||||
2779984|NCT00669331|Secondary|• (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations|Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times.|52 weeks||||hospitalisations/year||95% Confidence Interval|Mean
2779985|NCT00669331|Secondary|Safety Profile - Hematology|hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline.|52 weeks||||participants|||Number
2779986|NCT00669331|Secondary|Safety Profile - Clinical Chemistry|Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline.|52 weeks||||participants|||Number
2779987|NCT00669331|Secondary|Safety Profile - Sputum Microbiology|sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit|52 weeks||||participants|||Number
2779988|NCT00669331|Secondary|Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||mL/s||95% Confidence Interval|Least Squares Mean
2779989|NCT00669331|Secondary|Lung Function - Change in FEV1/FVC|FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC*100|52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||ratio (expressed as a %)||95% Confidence Interval|Least Squares Mean
2779990|NCT00669331|Secondary|Lung Function - Change in FVC (Forced Vital Capacity)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||mL||95% Confidence Interval|Least Squares Mean
2779991|NCT00669331|Secondary|Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment|||mL||95% Confidence Interval|Least Squares Mean
2779992|NCT00669331|Secondary|Daytime Sleepiness Scores|Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks|52 weeks||||units on a scale||Standard Deviation|Mean
2779995|NCT00669331|Secondary|Time to First Graded Exacerbation|Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation.|52 weeks|Randomised and treated|||months||95% Confidence Interval|Median
2779996|NCT00669331|Secondary|Antibiotic Use Prescribed for Treated Pulmonary Exacerbations|Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event.|52 weeks|Randomised and treated (referred to as ITT)|||events/year|||Number
2779997|NCT00669331|Secondary|Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score|The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit.|52 weeks|Randomised and treated with one or more post-baseline SGRQ data available|||units on a scale||Standard Deviation|Mean
2779998|NCT00669331|Primary|Rate of Graded Pulmonary Exacerbations|A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of >20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year|52 weeks|Randomised and Treated (referred to as the ITT population in this trial)|||GPE events per year|||Number
2779999|NCT00669318|Secondary|Time to Retreatment|Time to subsequent therapy is defined to be the time from the registration to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier|Follow-up status and retreatment information will be collected up to 5 years from registration||||months||95% Confidence Interval|Median
2780000|NCT00669318|Secondary|Progression-free Survival|The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration||||months||95% Confidence Interval|Median
2780001|NCT00669318|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration||||months||95% Confidence Interval|Median
2780002|NCT00669318|Secondary|Overall Response Rate (Complete and Partial Response)|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. A bone marrow biopsy with evidence of <30% lymphocytes and no nodules.~Patients who fulfill all criteria for a CR but have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity will be classified as CR with incomplete marrow recovery (CRi).~A Partial Response (PR) requires a 50% reduction in nodes and liver/spleen measurements and at least two of the following: absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, or a >50% reduction in lymphocytes.~Here we report the rate of overall response as the number of patients attaining a CR, PR, or CRi status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)||||percentage of patients||95% Confidence Interval|Number
2780003|NCT00669318|Primary|Complete Response Rate|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. In addition, a bone marrow biopsy with evidence of <30% lymphocytes and no nodules.~Here we report the rate of complete response as the number of patients attaining a CR status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)||||percentage of participants||95% Confidence Interval|Number
2780004|NCT00669279|Secondary|Peripheral Blood Pressure||Measured at baseline, 2 weeks, and 4 weeks.|||||||
2780005|NCT00669279|Primary|Central Aortic Blood Pressure||Measured at baseline and 4 weeks.||||mmHg||Standard Error|Mean
2780006|NCT00669240|Secondary|Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium|Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms)|Week 7 and Week 13 or 14 (Week 13/14)|All subjects population in Belgium; n=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
2780007|NCT00669240|Secondary|Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program|"Number of participants who answered 'yes' to the question Did you register with LifeREWARDS? (LifeREWARDS not available in Greece.)"|Week 12|All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).|||participants|||Number
2780008|NCT00669240|Secondary|Number of Participants Who Received Varenicline, by Duration of Treatment in Days||Baseline through Week 12 or Week 24|All-subjects population; Week 24 if a maintenance period was prescribed.|||participants|||Number
2780029|NCT00669162|Primary|Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy|Defined as percentage of patients that complete full dose of Radiation Therapy (RT)|8 Months||||percentage of participants|||Number
2780009|NCT00669240|Secondary|Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12|A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice|Week 12|All-subjects population|||participants|||Number
2780010|NCT00669240|Secondary|Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11|"Responders are participants who answered no to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice."|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population; n=number of participants in the All-subjects population with analyzable data (responders and non-responders) who were assessed for smoking cessation at the time point (per local clinical practice) .|||participants|||Number
2780011|NCT00669240|Secondary|Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11|Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice.|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population|||participants|||Number
2780012|NCT00669240|Secondary|Number of Treatment Responders in Belgium at Week 12 and at Week 24|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12 and Week 24|All-subjects population in Belgium|||participants|||Number
2780013|NCT00669240|Secondary|Number of Treatment Responders at Week 12|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12|All-subjects population|||participants|||Number
2780014|NCT00669240|Secondary|Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks|"Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12 and Week 24|All-subjects population in Belgium|||participants|||Number
2780015|NCT00669240|Secondary|Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks|"Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12|All-subjects population|||participants|||Number
2780016|NCT00669240|Primary|Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)|Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.|Baseline through Week 12 or Week 24|Safety population, which is identical to the all-subjects population: all enrolled subjects who received at least 1 dose (including partial doses) of varenicline; Week 24 if a maintenance period was prescribed.|||participants|||Number
2780017|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 24|ITT population. N's reflect patients who received at least one dose of study drug in the open-label period.|||Percentage of BSA||Standard Deviation|Mean
2780018|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 12|ITT population. N's reflect patients who received at least one dose of study drug or placebo in the double-blind treatment period.|||Pecentage of BSA||Standard Deviation|Mean
2780019|NCT00669214|Secondary|Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks|"Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was no itching, 5 was moderate itching, and 10 was severe itching."|Week 24|ITT population. If VAS at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 168 was missing for a patient who completed the Day 161 dose, the last available VAS was used for analysis.|||Points on VAS||Standard Deviation|Mean
2780020|NCT00669214|Secondary|Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks|"Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was no itching, 5 was moderate itching, and 10 was severe itching."|Week 12|ITT population. If VAS at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 84 was missing for a patient who completed treatment, the last available VAS from the treatment period was used for analysis.|||Points on VAS||Standard Deviation|Mean
2780021|NCT00669214|Secondary|Mean Change in Scalpdex Score at 24 Weeks|Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|Week 24|ITT population. If Scalpdex at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 168 was missing for a patient who completed the Day 161 dose, the last available Scalpdex was used for analysis.|||Points on Scalpdex||Standard Deviation|Mean
2780022|NCT00669214|Secondary|Mean Change in Scalpdex Score at 12 Weeks|Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84|ITT population. If Scalpdex at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 84 was missing for a patient who completed treatment, the last available Scalpdex from the treatment period was used for analysis.|||Points on Scalpdex||Standard Deviation|Mean
2780023|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks|Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.|Week 24|ITT population. If PGA rating at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 168 was missing for a patient who completed the Day 161 dose, the last available PGA rating was used for analysis.|||Proportion of patients||95% Confidence Interval|Number
2780024|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks|"Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84)~Physician's Global Assessment (PGA) scale:~0: Clear. No signs of plaque psoriasis.~Almost clear. Just perceptible erythema and just perceptible scaling.~Mild disease. Light pink erythema with minimal scaling.~Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.~Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening."|Week 12|ITT population. If PGA rating at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 84 was missing for a patient who completed treatment, the last available PGA rating from the treatment period was used for analysis.|||Proportion of patients|||Number
2780025|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.|||Proportion of patients||95% Confidence Interval|Number
2780026|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|ITT population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.|||Proportion of patients|||Number
2780027|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.|||Proportion of patients||95% Confidence Interval|Number
2780028|NCT00669214|Primary|Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.|||Proportion of patients|||Number
2780635|NCT00665626|Secondary|Bilirubin >2x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780030|NCT00669110|Other Pre-specified|Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)|Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable laboratory data. Participants may be represented in >1 category.|||participants|||Number
2780031|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)|PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data.|||participants|||Number
2780032|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)|ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data. Participants may be represented in >1 category.|||participants|||Number
2780033|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate|PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).|||participants|||Number
2780034|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight|Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).|||participants|||Number
2780035|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)|PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).|||participants|||Number
2780036|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.|||participants|||Number
2780037|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.|||participants|||Number
2780038|NCT00669110|Other Pre-specified|Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved).|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.|||percentage of participants|||Number
2780203|NCT00667563|Primary|Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count|Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests|Screening/Week 0, Weeks 2, 10, 26, and 52.|Intent-to-treat|||participants|||Number
2780039|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.|||percentage of participants|||Number
2780040|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.|||percentage of participants|||Number
2780041|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score|HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.|||scores on a scale||Standard Deviation|Mean
2780042|NCT00669110|Other Pre-specified|Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale - Revised (CDRS-R)|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1).|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.|||percentage of participants|||Number
2780043|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)|Intent to Treat population (ITT): all treatment assigned participants with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).|||scores on a scale||Standard Deviation|Mean
2780044|NCT00669110|Primary|Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)|Safety population (Baseline=Core study) includes all treatment assigned participants with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.|||participants|||Number
2780045|NCT00669110|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline (Extension study) up to Extension study Week 29 Follow up visit|Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.|||participants|||Number
2780046|NCT00669071|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events|Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events|Baseline to week 10|Safety|||participants|||Number
2780047|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2780048|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2780636|NCT00665626|Secondary|Bilirubin >1.5x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780049|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2780050|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2780051|NCT00669071|Secondary|Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10|Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin.|Baseline to Week 6 and Baseline to Week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||units on a scale||Standard Deviation|Mean
2780052|NCT00669071|Secondary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure|Number of participants who were a success or failure with regards to melasma severity at Week 6 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2780053|NCT00669071|Primary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma|Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2780054|NCT00669032|Secondary|Mean Daily Dose of Paracetamol Consumption|Mean daily dose of paracetamol consumption throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||mg/day||Standard Deviation|Mean
2780055|NCT00669032|Secondary|Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis|Consumption of rescue medication (paracetamol/NSAID) for osteoarthritis throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
2780056|NCT00669032|Secondary|Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up|"Percentage of patients with an increase in the score of patient's global assessment by at least 20% and at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
2780057|NCT00669032|Secondary|Function Improvement 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in physical function score of at least 20% or at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
2780058|NCT00669032|Secondary|Overall Pain Reduction 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in pain score of at least 20% or at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
2780059|NCT00669032|Secondary|Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up|"Percentage of patients with a decrease in pain or physical function score of at least 50% and at least 20mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of patients|||Number
2780060|NCT00669032|Secondary|Responders OARSI 2004 at 34 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 34 months follow-up visit (6 months after fourth cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|34 months (6 months after fourth cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
2780120|NCT00667992|Secondary|Peak Exploratory Flow (PEF) Morning|Peak Exploratory Flow (PEF) recorded daily in the morning|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters/minutes||95% Confidence Interval|Least Squares Mean
2786525|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose SBP <140 mmHg|6 months and 12 months|FAS|||percentage of participants|||Number
2780061|NCT00669032|Secondary|Responders OARSI 2004 at 27 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 27 months follow-up visit (12 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|27 months (12 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
2780062|NCT00669032|Secondary|Responders OARSI 2004 at 21 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 21 months follow-up visit (6 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|21 months (6 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
2780063|NCT00669032|Secondary|Responders OARSI 2004 at 14 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 14 months follow-up visit (6 months after second cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|14 months (6 months after second cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
2780064|NCT00669032|Secondary|Responders OARSI 2004 at 7 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 7 months follow-up visit (6 months after first cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|7 months (6 months after first cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
2780065|NCT00669032|Primary|Responders OARSI 2004 at the End of Follow-up|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.|||percentage of responders|||Number
2780066|NCT00669019|Secondary|Progression-free Survival|Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.|Up to 2 years||||weeks||95% Confidence Interval|Median
2780067|NCT00669019|Primary|Objective Response Rate|"Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum LD; Objective response = CR + PR.~CT scans will be performed at baseline and every 4-8 weeks while on study."|Up to 25 weeks||||percentage of participants||95% Confidence Interval|Number
2780068|NCT00668902|Primary|DOBmax (Maximum Value of DOB)|"The stable isotope [13C]pantoprazole is O-demethylated by cytochrome P450 CYP2C19 and that the 13CO2 produced and exhaled in breath as a result can serve as a safe, rapid, and noninvasive phenotyping marker of CYP2C19 activity in vivo.~Exhaled 13CO2 and 12CO2 were measured by IR spectroscopy before (baseline) and 2.5 to 120 min after dosing. Ratios of 13CO2/12CO2 after [13C]pantoprazole relative to 13CO2/12CO2 at baseline were expressed as change over baseline (DOB)."|baseline and 2.5, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, and 120 min after dosing||||ratio||Standard Deviation|Mean
2780204|NCT00667563|Primary|Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0|Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients|52 weeks from study entry|Intent-to-treat|||Grade 3/4 adverse events per 100 patient||95% Confidence Interval|Number
2780069|NCT00668863|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 11 cycles (1 cycle = 6 weeks)|Safety analysis set was defined as the same population as the Full Analysis Set.|||Participants|||Number
2780070|NCT00668863|Secondary|Plasma Concentration at Steady State (Css) of 5-FU|Concentration at 22 hour post start of 5-FU infusion were to be used as Css if 5-FU concentrations suggested steady state at 22 hours time point.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng/mL||Standard Deviation|Mean
2780071|NCT00668863|Secondary|Volume of Distribution at Steady State (Vss) of Irinotecan|Vss was calculated using following equation: CL x mean residence time (MRT), where MRT = the area under the first moment curve from zero time to infinity (AUMC 0-∞)/AUC 0-∞− (infusion time/2), AUMC 0-∞ = the area under the first moment curve from zero time to time t (AUMC t)+ ((t x Ct*)/ kel) + (Ct* / kel^2), AUMC t is calculated using the linear trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||L||Standard Deviation|Mean
2780072|NCT00668863|Secondary|Clearance of Irinotecan|CL is calculated as dose divided by AUC 0-∞|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||L/hour||Standard Deviation|Mean
2780073|NCT00668863|Secondary|Terminal Phase Elimination Half-life (t1/2) of Irinotecan|Terminal phase half-life of irinotecan was calculated as ln 2/ kel.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||hours||Standard Deviation|Mean
2780074|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan|"AUC last of irinotecan and its metabolite SN-38 were calculated using the Linear/Log trapezoidal method.~AUC∞ of irinotecan was calculated using following equation; AUC last+(C*t/kel), where Ct* is the estimated concentration at the time of the last quantifiable concentration, kel is terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile."|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng.h/mL||Standard Deviation|Mean
2780075|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||hours||Full Range|Mean
2780076|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|Plasma samples were assessed at prior to initiation of irinotecan (and l-leucovorin) infusion, 1, 2 (predose for 5-FU bolus), 4, 8, and 24 hours after initiation of irinotecan infusion, and Cmax of irinotecan and its metabolite SN-38 were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng/mL||Standard Deviation|Mean
2780077|NCT00668863|Secondary|Apparent Oral Clearance (CL/F) of Sunitinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||L/hour||Standard Deviation|Mean
2780078|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib|AUC 0-24 was determined using the Linear/Log trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng.h/mL||Standard Deviation|Mean
2780079|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||hours||Full Range|Mean
2780080|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.|Plasma concentrations were assessed at predose, 2, 4, 6, 8, and 24 hours postdose and Cmax and Ctrough of sunitinib, its metabolite SU012662, and the total (sunitinib + SU0122662) were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.|||ng/mL||Standard Deviation|Mean
2780081|NCT00668863|Secondary|Duration of Response (DR)|DR is defined as the time from the first objective documentation of complete or partial response that is subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurs first. The definition of censorship is the same as PFS.|Up to 11 cycles (1 cycle = 6 weeks)|Analysis set was consisted of participants with a confirmed objective tumor response (CR or PR) among Full Analysis Set.|||weeks||95% Confidence Interval|Median
2780121|NCT00667992|Secondary|Rescue Medication Total|The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Number of inhalations/24 hours||95% Confidence Interval|Least Squares Mean
2780715|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 HOMA-IR results.|||mg/dL x uIU/mL / 405||Inter-Quartile Range|Median
2780082|NCT00668863|Secondary|Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)|ORR is defined as the percentage of participants with best overall response of either a confirmed complete (CR) or partial response (PR) relative to the number of participants in FAS. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Median
2780083|NCT00668863|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause. OS data was censored on the day following the date of the last contact at which the patient is known to be alive.|Up to 11 cycles (1 cycle = 6 weeks)|Median OS was not calculable due to the large number of censored events (63 out of 71 were censored).|||weeks||95% Confidence Interval|Median
2780084|NCT00668863|Primary|Progression-Free Survival (PFS)|"PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first.~PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis."|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.|||weeks||95% Confidence Interval|Median
2780085|NCT00668811|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.|12 months after last patient completes treatment||||days||Inter-Quartile Range|Median
2780086|NCT00668811|Primary|Progression Free Survival|Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).|12 months after last patient completes treatment||||days||Inter-Quartile Range|Median
2780087|NCT00668785|Secondary|Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010|6 subjects were enrolled in the study: 2 in the observation arm and 4 in the treatment arm. There were only 4 visits in the schedule of assessments and 3 of the subjects missed 2 visits or more. Due to the lack of data collected, the percentage of patients that maintain pre-PRP visual acuity could not be accurately analyzed and calculated.||||||
2780088|NCT00668785|Secondary|Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010|6 subjects were enrolled in the study: 2 in the observation arm and 4 in the treatment arm. There were only 4 visits in the schedule of assessments and 3 of the subjects missed 2 visits or more. Due to the lack of data collected, the mean change in central foveal thickness could not be accurately analyzed and calculated.||||||
2780089|NCT00668785|Primary|Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010|6 subjects were enrolled in the study: 2 in the observation arm and 4 in the treatment arm. There were only 4 visits in the schedule of assessments and 3 of the subjects missed 2 visits or more. Due to the lack of data collected, the mean change in visual acuity could not be accurately analyzed and calculated.||||||
2780090|NCT00668746|Secondary|Micocycline-Resistance From Saliva Sample|Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects|Baseline, Day 30 and Day 180|ITT|||Percentage of Subjects|||Number
2780091|NCT00668746|Secondary|Micocycline-Resistance From Plaque Samples|Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples|Baseline, Day 30 and Day 180|ITT|||Percentage of Subjects|||Number
2780092|NCT00668746|Primary|Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture|Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.|from Baseline to Day 30 and Day 180|intention to treat (ITT)|||Percentage Change||Standard Deviation|Mean
2780093|NCT00668733|Primary|Number of Participants With Recurrence of AK Lesions|The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.|Up to one year|Efficacy analyses were conducted on the evaluable subject population defined as all subjects who were eligible and enrolled in the follow-up study. All results were summarized overall and by original Phase 3 randomized treatment regimen and dose group. Actinic keratosis recurrence was categorized by presence or absence only.|||participants|||Number
2780094|NCT00668564|Secondary|Overall Survival|Number of patients alive at timepoints.|Day 100, 1 Year, 3 Years|Year 3 survival endpoint was not done due to study being terminated prematurely.|||Participants|||Number
2780095|NCT00668564|Primary|Number of Patients Achieving Engraftment|Rate of successful engraftment - patients who achieved and sustained donor engraftment; donor chimerism by day 100 of at least 90% after undergoing hematopoietic stem cell transplantation.|Day 100||||Participants|||Number
2780253|NCT00667355|Secondary|Mean Change From Baseline in Chest Expansion|Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||cm||95% Confidence Interval|Mean
2780096|NCT00668525|Secondary|Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8|The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).|Change from baseline in HAM-D at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline HAMD total score as a covariate.|||Units on a scale||Standard Error|Mean
2780097|NCT00668525|Primary|Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.|The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).|Change from baseline in MADRS total score at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate.|||Units on a scale||Standard Error|Mean
2780098|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 52 follow-up||||units on a scale||Standard Error|Mean
2780099|NCT00668434|Secondary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 52 follow-up||||units on a scale||Standard Error|Mean
2780100|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 3 follow-up||||units on a scale||Standard Error|Mean
2780101|NCT00668434|Primary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 3 follow-up||||units on a scale||Standard Error|Mean
2780102|NCT00668395|Primary|Effect of CYP2B6 Genotype on Efavirenz Clearance|Efavirenz clearance is a measure of rate of elimination of the drug from the body. We used this measure to evaluate differences in rate of elimination of efavirenz at a single dose and after multiple dosing within three CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and CYP2B6*6/*6). Efavirenz clearance was measured in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6) and slow metabolizer (CYP2B6*6/*6) at a single 600 mg oral dose of efavirenz and then after multiple dosing (autoinduction), i.e., the administration of efavirenz (600 mg/day) for 17 days. Single and multiple dose efavirenz clearance was measured and compared to determine the extent of autoinduction within this genotype group.|Efavirenz clearance at single dose and multiple dose stratified by CYP2B6 genotypes||||ml/h/kg||Standard Deviation|Mean
2780103|NCT00668382|Primary|Number of Subjects With Greater Than Grade 3 or 4 Toxicity|Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection|1 month|Dose escalating Phase 1 scheme: three participants for each dose cohort. The second patient in the last (10 mg) dose cohort developed and adverse event (infection at injection site) and so three more participants were entered and analyzed at that dose|||participants|||Number
2780104|NCT00668317|Secondary|Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire||8 weeks|||||||
2780105|NCT00668317|Primary|Change in Methacholine Sensitivity|"Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).~To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine"|baseline and 8 weeks|All subjects recruited with efficacy data recorded after week T0 will be included in the ITT population for analysis. Assuming a within subject standard deviation(for change in PC20) of no more than 2.71 units, 30 subjects are sufficient to provide 80% power to detect a treatment difference of 1.8 units using a 5% two sided significance test|||mg/ml||Standard Deviation|Mean
2780106|NCT00668265|Secondary|Beck Depression Inventory at 16 Weeks|To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.|16 weeks|Data were not analyzed. PI left institution, and did not respond to attempts top contact him.||||||
2780107|NCT00668265|Primary|Hamilton Anxiety Scale at 16 Weeks|Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety|16 weeks|Data was not analyzed: PI left the institution and the study was terminated||||||
2780108|NCT00668200|Secondary|Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)|The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.|End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.|||percentage of patients|||Number
2780122|NCT00667992|Secondary|Rescue Medication Evening|The average of means for inhalations of rescue medication in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Number of inhalations||95% Confidence Interval|Least Squares Mean
2780716|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 LFT results.|||x ULN||Inter-Quartile Range|Median
2780109|NCT00668200|Secondary|Change From Baseline in Serum Calcium (mmol/L) - Safety Population|Change from baseline = endpoint - baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.|Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.|||mmol/L||Standard Deviation|Mean
2780110|NCT00668200|Primary|Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.|To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.|at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|Safety population which includes 81 patients was used. 75 of the 81 patients in the safety population met the criteria. 6 patients did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline.|||percentage of patients|||Number
2780111|NCT00668148|Secondary|Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)||30-day safety follow-up|Zero participants analyzed. Analysis was not performed due to lack of available assay.||||||
2780112|NCT00668148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths|TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs, serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.|Baseline through study completion (up to 112.9 weeks)|Enrolled participants who received any quantity of IMC-A12.|||Participants|||Count of Participants
2780113|NCT00668148|Secondary|Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)]|CBR was reported by disease condition. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria. Percentage of participants with best overall response is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100.|Baseline through study completion (up to 105.4 weeks)|Enrolled participants who received any quantity of IMC-A12.|||percentage of participants||95% Confidence Interval|Number
2780114|NCT00668148|Secondary|Overall Survival (OS)|OS was reported by disease condition and defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.|Baseline to date of death from any cause (up to 112.9 weeks)|Enrolled participants who received any quantity of IMC-A12. Five (5) participants in Ewing's sarcoma/PNET, 4 participants in rhabdomyosarcoma, 12 participants in leiomyosarcoma, 11 participants in adipocytic sarcoma, and 5 participants in synovial sarcoma groups were censored for analysis.|||weeks||95% Confidence Interval|Median
2780115|NCT00668148|Secondary|Duration of Response||Date of first response to the date of progression or death due to any cause (up to 105.4 weeks)|Zero participants analyzed. Duration to Response for CR and PR data was not collected for analysis per study report.||||||
2780116|NCT00668148|Secondary|Time to Response||Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks)|Zero participants analyzed. Time to Response for CR and PR data was not collected for analysis per study report.||||||
2780117|NCT00668148|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was reported by disease condition and defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.|Baseline to measured PD (up to 105.4 weeks)|Enrolled participants who received any quantity of IMC-A12.|||percentage of participants||95% Confidence Interval|Number
2780118|NCT00668148|Secondary|Progression-Free Survival (PFS)|PFS was reported by disease condition and defined as the interval from the date of first dose until disease progression or death whichever occurred earlier. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience disease progression or death.|Baseline to measured PD (up to 105.4 weeks)|Enrolled participants who received any quantity of IMC-A12. Three (3) participants in Ewing's sarcoma/PNET, 1 participant in rhabdomyosarcoma, 4 participants in leiomyosarcoma, 6 participants in adipocytic sarcoma, and 3 participants in synovial sarcoma groups were censored for analysis.|||weeks||95% Confidence Interval|Median
2780119|NCT00668148|Primary|Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks|PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100.|Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks|Enrolled participants who received any quantity of IMC-A12.|||percentage of participants||95% Confidence Interval|Number
2790697|NCT00589472|Secondary|Levels of DHEA-S in Blood From Radical Prostatectomy Specimens||Up to 1 year||||mcg/dL||95% Confidence Interval|Median
2780123|NCT00667992|Secondary|Rescue Medication Morning|The average of means for inhalations of rescue medication in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Number of inhalations||95% Confidence Interval|Least Squares Mean
2780124|NCT00667992|Secondary|Asthma Symptom Score Total|Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Units on a scale||95% Confidence Interval|Least Squares Mean
2780125|NCT00667992|Secondary|Asthma Symptom Score Evening|Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Units on a scale||95% Confidence Interval|Least Squares Mean
2780126|NCT00667992|Secondary|Asthma Symptom Score Morning|Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Units on a scale||95% Confidence Interval|Least Squares Mean
2780127|NCT00667992|Secondary|eNO (Exhaled Nitrogen Oxide)|eNO ratio of baseline|baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Ratio||95% Confidence Interval|Geometric Mean
2780128|NCT00667992|Secondary|FEF 25-75 (Forced Expiratory Flow 25-75)|FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters/seconds||95% Confidence Interval|Least Squares Mean
2780129|NCT00667992|Secondary|FEV1 (Forced Expiratory Volume in 1 Second)|FEV1 change from baseline|Baseline to week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters||95% Confidence Interval|Least Squares Mean
2780130|NCT00667992|Secondary|Peak Exploratory Flow (PEF)|Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.|Baseline to week 2 recorded daily|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Liters/minutes||95% Confidence Interval|Least Squares Mean
2780131|NCT00667992|Primary|PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)|"Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.~The ratio of Methacholine concentration measured at 2 weeks to that at Baseline."|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).|||Ratio||95% Confidence Interval|Geometric Mean
2780132|NCT00667875|Secondary|Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance|Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime|16 weeks treatment trial||||Percent of riboflavin positive samples||Standard Deviation|Mean
2780133|NCT00667875|Secondary|Pill Counts During Treatment|Compliance with medication as determined by pill counts|16-week||||Percent of pills taken||Standard Deviation|Mean
2780134|NCT00667875|Primary|Percent Heavy Drinking Days|percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)|16 weeks||||percent of days||Standard Deviation|Mean
2780135|NCT00667875|Primary|Drinks Per Drinking Day|Standard drinks per drinking day|16-week treatment period||||drinks per drinking day||Standard Deviation|Mean
2780136|NCT00667849|Other Pre-specified|Treatment Compliance|The percent of subjects who used the device greater than or equal to 18 minutes per day over 80% of the days in their treatment period.|Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)|FAS with compliance data (subjects who returned the device)|||percentage of compliant participants|||Number
2780137|NCT00667849|Primary|Time (Days) to Radiographic Healing of Tibial Fractures|Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier|over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.|||days||Inter-Quartile Range|Median
2780138|NCT00667849|Primary|Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)|Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best|Over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.|||units on a scale||95% Confidence Interval|Least Squares Mean
2780205|NCT00667511|Primary|Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.|Study Week 20|Includes all patient reported treatments.|||events per 100 treatments|Participants||Number
2780139|NCT00667810|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
2780140|NCT00667810|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
2780141|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants|||Number
2780142|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants||95% Confidence Interval|Number
2780143|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Percentage of participants|||Number
2780144|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Number of participants||95% Confidence Interval|Number
2780145|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
2780146|NCT00667810|Secondary|Time to Median Placebo Deterioration on DAD Total Score|The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
2780147|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|78 weeks||||Days||95% Confidence Interval|Median
2780148|NCT00667810|Secondary|Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Days||95% Confidence Interval|Median
2780149|NCT00667810|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.|39 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Years||Standard Error|Mean
2780150|NCT00667810|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.|39 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units/Year||Standard Error|Mean
2780151|NCT00667810|Secondary|The Change From Baseline in Brain Volume at Week 71|Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|71 Weeks|The vMRI population Included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.|||mL/year||Standard Error|Least Squares Mean
2780152|NCT00667810|Secondary|The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.|Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).|||pg/mL||Standard Error|Least Squares Mean
2780153|NCT00667810|Secondary|The Change From Baseline in Brain Amyloid Burden at Week 71.|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|71 Weeks|PiB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one post baseline PiB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI≥1.35 at baseline.|||SUVr||Standard Error|Least Squares Mean
2780154|NCT00667810|Primary|The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.|78 weeks|The Modified Intent-to-Treat (mITT) population included as all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.|||Units on a scale||Standard Error|Least Squares Mean
2780155|NCT00667810|Primary|The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.|||Units on a scale||Standard Error|Least Squares Mean
2780156|NCT00667745|Secondary|Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI)|The Modified Scale for Suicide Ideation (MSSI) assesses the presence of absence of suicide ideation and the degree of severity of suicidal ideas. The time frame is from the point of interview and the previous 48 hours. It uses 13 items from the Scale for Suicidal Ideation (SSI) and 5 new items. The modifications increased both reliability and validity. The scale was also changed to range from 0 to 3, yielding a total score ranging from 0 to 54. A total score is attained by summing all of the items. A score between 0-8 indicates low suicidal ideation; 9-20 indiciates mild-moderate suicidal ideation; 21+ indicates severe suicidal ideation.|Measured over 6 months||||units of scale||Standard Deviation|Mean
2780157|NCT00667745|Secondary|Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS)|The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale with 0 indicating that symptoms are absent and 8 indicating that symptoms are severe (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale, with 0 indicating that symptoms are absent and 4 indicating that symptoms are severe (Elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, and insight). Total scores can vary from 0-60, with 0 indicating that symptoms are completely absent and 60 indicating that the patient is severely manic.|Measured over 6 months||||units on a scale||Standard Deviation|Mean
2780158|NCT00667745|Secondary|Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS)|"The MADRS is a 10-item measure and has a fixed scaling of seven points (from 0 through 6), with 0 representing sypmtoms that are not present and 6 being the most severe symptoms. When completed, the sum of each individual item is taken to create an overall score.~Overall scores:~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|Measured over 6 months||||units on a scale||Standard Deviation|Mean
2780159|NCT00667745|Primary|Number of Necessary Medication Adjustments|"Metric Definition (Necessary Clinical Adjustments (NCA)): Medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. This was determined with the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making.~Range: whole numbers~Relevant time points: Weeks 2, 4, 6, 8, 12, 16, 20, and 24."|Measured over 6 months||||Adjustments||Standard Deviation|Mean
2780160|NCT00667745|Primary|Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score|"Scale: Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Construct: This scale holistically measures severity of a participant's depression, mania, and overall illness.~Range: 0- not assessed, 1-normal (not at all ill), 2- borderline mentally ill, 3- mildly ill, 4- moderately ill, 5- markedly ill, 6- severely ill, 7- among the most extremely ill patients."|Relevant time points: baseline and week 24||||units on a scale||Standard Deviation|Mean
2780161|NCT00667732|Secondary|The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment|efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%|After 24 weeks of randomized treatment|Per protocol, all participants who completed treatment|||percentage of participants|||Number
2780162|NCT00667732|Primary|The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment||After 24 weeks of randomized treatment|Intent to treat. All participants randomized to treatment.|||percentage of participants|||Number
2780163|NCT00667693|Secondary|The Number of Patients With Bleeding||From the start of intubation until 24 hours after surgery||||Participants|||Count of Participants
2780164|NCT00667693|Secondary|The Number of Patients With Different Number of Intubation Attempts|We summarized the number of patients with one, two or three intubation attempts.|From the start of intubation until 24 hours after surgery||||Participants|||Count of Participants
2780165|NCT00667693|Secondary|Successful Intubation on the First Attempt|The count number of successful intubation on the first attempt|From the start of intubation until 24 hours after surgery||||Participants|||Count of Participants
2780166|NCT00667693|Secondary|Ease of Intubation|Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation|From the start of intubation until 24 hours after surgery||||units on a scale||Standard Deviation|Mean
2780167|NCT00667693|Primary|Time to Intubation|time between sufficient muscle relaxant and placement of intubation tube|time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds||||seconds||Inter-Quartile Range|Median
2780168|NCT00667615|Secondary|Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|through study completion, an average of 1 year||||percentage of participants with CR|||Number
2780169|NCT00667615|Primary|Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma|Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in >= 50% of participants|through study completion, an average of 1 year||||mg/m2|||Number
2780170|NCT00667602|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination|"Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.~safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups"|From day 1 to day 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2780171|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.~Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
2780172|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C."|1 month postvaccination.|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
2780184|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|"Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.~Serogroup C is not shown here as it is shown in other outcome measures."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780173|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.~Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780174|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780175|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).|6-18 months postvaccination.|Analysis was done on PP set (only for subjects enrolled in Australia).|||Titers||95% Confidence Interval|Geometric Mean
2780176|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (subjects enrolled in Australia).|||Titers||95% Confidence Interval|Geometric Mean
2780177|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).|1 month postvaccination 6-18 months postvaccination|Analysis was done on PP set (persistence subset).|||Percentages of subjects||95% Confidence Interval|Number
2780178|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (persistence subgroup).|||Percentages of subjects||95% Confidence Interval|Number
2780179|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)|"To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.~Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL."|1 month postvaccination|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780180|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)|"The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.~For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.~Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.~Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8.~HepB (HBV): primary endpoint ELISA >=10mU/mL.~PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL."|1 month postvaccination|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780181|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y|"The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.~The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y."|1 month postvaccination|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
2780182|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.|1 month postvaccination|Analysis was done on PP set.|||Titers||95% Confidence Interval|Geometric Mean
2780183|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.|||Titers||95% Confidence Interval|Mean
2780200|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-6|Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline|28 weeks|Per-protocol participants with undetectable antibodies to HPV-6 at baseline|||participants|||Number
2780185|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y|"Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780186|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.|||Percentages of subjects||95% Confidence Interval|Number
2780187|NCT00667602|Primary|Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.|1 month postvaccination|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2780188|NCT00667589|Secondary|Change in Skindex-16 Total Score Between Baseline and 2 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.|baseline and 2 weeks|Results for one subject from the Tazarotene 0.1% cream arm and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not completed a Skindex-16 questionnaire at 2 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.|||units on a scale||Standard Deviation|Mean
2780189|NCT00667589|Primary|Change in Skindex-16 Total Score Between Baseline and 8 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.|baseline and 8 weeks|Results for subjects from the fluocinonide 0.05% cream arm, subjects from the Tazarotene 0.1% cream arm, and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not complete a Skindex-16 questionnaire at 8 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.|||units on a scale|||Number
2780190|NCT00667576|Secondary|Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH values ≤ 180 pg/mL. Missing data were not imputed.|||days||Standard Deviation|Mean
2780191|NCT00667576|Secondary|Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH decreases of ≥ 50% from baseline. Missing data were not imputed.|||days||Standard Deviation|Mean
2780192|NCT00667576|Secondary|Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level||Through Week 13|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated subjects, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||Percentage of participants|||Number
2780193|NCT00667576|Secondary|Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||Percentage of participants|||Number
2780194|NCT00667576|Secondary|Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||pg/mL||95% Confidence Interval|Mean
2780195|NCT00667576|Other Pre-specified|Percentage of Subjects With Hyperphosphatemia|Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.|||Percentage of participants|||Number
2780196|NCT00667576|Other Pre-specified|Percentage of Subjects With Hypercalcemia|Hypercalcemia was defined as at least 1 adjusted calcium value > 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.|||Percentage of participants|||Number
2780197|NCT00667576|Primary|Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.|||Percentage of participants|||Number
2780198|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-18|Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline|28 weeks|Per-protocol population of participants with undetectable HPV-18 antibodies at baseline|||participants|||Number
2780199|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-11|Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline|28 weeks|Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline|||participants|||Number
2780206|NCT00667511|Primary|Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).|Study Week 20|Includes all electronically captured treatments.|||percentage of successful treatments|Participants|95% Confidence Interval|Number
2780207|NCT00667459|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable MCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||units on a scale||Standard Deviation|Mean
2780208|NCT00667459|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable PCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||units on a scale||Standard Deviation|Mean
2780209|NCT00667459|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain score at both baseline and 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.|||units on a scale||Standard Deviation|Mean
2780210|NCT00667459|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||units on a scale||Standard Deviation|Mean
2780211|NCT00667459|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||units on a scale||Standard Deviation|Mean
2780212|NCT00667459|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.|24 months post-operation|For this endpoint, the analysis consists of all subjects in the primary analysis dataset with 280 subjects in the investigational control and 265 subjects in the control group.|||percentage of participants|||Number
2780213|NCT00667459|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for hospital stay, which leads to 280 subjects in the investigational group and 265 subjects in the control group.|||days||Standard Deviation|Mean
2780214|NCT00667459|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for blood loss, which leads to 278 subjects in the investigational group and 263 subjects in the control group.|||ml||Standard Deviation|Mean
2780215|NCT00667459|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for operative time, which leads to 280 subjects in the investigational group and 265 subjects in the control group.|||hrs||Standard Deviation|Mean
2780216|NCT00667459|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.|||percentage of participants|||Number
2780717|NCT00665353|Secondary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.||Week 72 of Step 2|All enrolled subjects.|||proportion of participants||90% Confidence Interval|Number
2780217|NCT00667459|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||percentage of participants|||Number
2780218|NCT00667459|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.|||percentage of participants|||Number
2780219|NCT00667459|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.|||percentage of participants|||Number
2780220|NCT00667459|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||percentage of participants|||Number
2780221|NCT00667459|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 224 subjects in the investigational group and 164 subjects in the control group.|||percentage of participants|||Number
2780222|NCT00667459|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.|||percentage of participants|||Number
2780223|NCT00667459|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.|||percentage of participants|||Number
2780224|NCT00667459|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative;~Maintenance or improvement in neurological status;~Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of Postoperative Height - 6 Week Postoperative Height ≥ -2mm;~No serious adverse event classified as implant associated or implant/surgical procedure associated; and~No secondary surgical procedure classified as a failure."|24 months|The primary analysis dataset for this study consists of all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 226 investigational subjects and 171 control subjects.|||percentage of participants|||Number
2780225|NCT00667446|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age|"Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula:~(BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline)."|Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36|Intention-to-treat with available bone age data. N = participants with available data at each time point.|||ratio||Standard Deviation|Mean
2780226|NCT00667446|Secondary|Change From Baseline in Growth Rate|Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.|Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36|Intention-to-treat with available growth rate data. N = participants with available data at each time point.|||cm/year||Standard Deviation|Mean
2780227|NCT00667446|Secondary|Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)|The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2780228|NCT00667446|Secondary|Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)|The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2780229|NCT00667446|Secondary|Mean Peak-stimulated Luteinizing Hormone Concentration by Visit|Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.|Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36|Intention-to-treat. N = the number of participants with available data at each time point.|||mIU/mL||Standard Deviation|Mean
2780230|NCT00667446|Secondary|Percentage of Male Participants With Suppression of Basal Testosterone|The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 3, 6, 9, 12, 24, 30, and 36|Intention-to-treat male population. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2780231|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.~The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36."|Months 6, 9, 12, 24, 30, and 36|Intention-to-treat female population. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2780232|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.~The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36."|Day 1, Months 3, 6, 9, 12, and 24|Intention-to-treat female population. N = the number of participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2780233|NCT00667446|Primary|Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone|Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 6, 12, 24, and 36|Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2780234|NCT00667420|Secondary|Overall Survival|Overall survival (OS) is the duration from start of treatment to time of death from any cause.|duration from enrollment to death (up to 6 years)||||months||95% Confidence Interval|Median
2780235|NCT00667420|Secondary|Pathologic Complete Response Rate|For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.|at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)||||participants|||Number
2780236|NCT00667420|Secondary|Progression-Free Survival|measured from the first day of treatment to the day when conclusive evidence of new disease is found|up to 72 months|We enrolled 17 patients|||months||Standard Deviation|Mean
2780237|NCT00667420|Secondary|R0 Resection Rate|percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection|time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy||||percentage of participants|||Number
2780238|NCT00667420|Primary|Safety and Tolerability|Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy|after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)||||participants|||Number
2780239|NCT00667394|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|45 months||||Participants|||Number
2780240|NCT00667394|Primary|Progression-free Survival at 6 Months|Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months||||Percentage of participants||95% Confidence Interval|Median
2780241|NCT00667381|Other Pre-specified|Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations|Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.|At angiogram analysis||||participants|||Number
2780242|NCT00667381|Secondary|Number of Participants With Vascular Complications|"Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma > 5cm diameter, unexplained bleeding with a drop in Hgb >4 g/dL, or access site bleeding with drop in Hgb >3 g/dL.~Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee."|Immediate and up to 1 month after procedure.||||participants|||Number
2780243|NCT00667381|Secondary|Number of Patients With Accidental Femoral Venipunctures.|"Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted.~Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients."|Immediate||||participants|||Number
2780244|NCT00667381|Secondary|Time to Successful Sheath Insertion.|"Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion.~Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses."|Immediate||||seconds||Standard Deviation|Mean
2780245|NCT00667381|Primary|Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography|"Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses.~Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers."|Immediately, during procedure.||||participants|||Number
2780246|NCT00667368|Secondary|Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months|Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV.|2, 4, 6, 8, 10, 12 months after enrollment|All randomized participants|||percentage of participants|||Number
2780247|NCT00667368|Primary|One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment|Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.|At 4, 8, and 12 months after enrollment.||||Number infections per 100 person-years||95% Confidence Interval|Number
2780248|NCT00667355|Secondary|Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||units on scale||95% Confidence Interval|Mean
2780249|NCT00667355|Secondary|Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)|The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||TJC||95% Confidence Interval|Mean
2780250|NCT00667355|Secondary|Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||SJC||95% Confidence Interval|Mean
2780251|NCT00667355|Secondary|Mean Change From Baseline in Nocturnal Pain|Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = no pain and 100 = worst possible pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mm on scale||95% Confidence Interval|Mean
2780252|NCT00667355|Secondary|Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||units on a scale||95% Confidence Interval|Mean
2780254|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||units on scale||95% Confidence Interval|Mean
2780255|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission|Partial remission is defined as a score of less than 20 units (on a scale of 0-100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780256|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780257|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]).|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780258|NCT00667355|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP)|CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mg/dL||95% Confidence Interval|Mean
2780259|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0-100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on last observation carried forward (LOCF).|||mm on scale||95% Confidence Interval|Mean
2780260|NCT00667355|Secondary|Mean Change From Baseline in Total Back Pain|Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = no pain and 100 = most severe pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mm on scale||95% Confidence Interval|Mean
2780261|NCT00667355|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity|Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = none and 100 = severe).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.|||mm on scale||95% Confidence Interval|Mean
2780262|NCT00667355|Secondary|Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)|BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780263|NCT00667355|Secondary|Number of Subjects Achieving ASAS 70|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780264|NCT00667355|Secondary|Number of Subjects Achieving ASAS 50|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780265|NCT00667355|Secondary|Number of Subjects Achieving ASAS 20|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on non-responder imputation (NRI), for which subjects with a missing value at a visit were imputed as a non-responder for that visit.|||Subjects|||Number
2780296|NCT00667251|Secondary|CNS Metastases at the Time of Progression (ITT)||Incidence rate of CNS metastases at first progression assessed up to 39 months|178 Lapatinib patients with metastases assessed for CNS metastases; 157 Trastuzumab patients with metastases assessed for CNS metastases.|||CNS metastases|||Number
2780266|NCT00667355|Primary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Week 12|For all non-responder imputation (NRI) analyses, subjects with a missing value at a visit were imputed as a non-responder for that visit. Observed cases is based on a total of 40 subjects analyzed (vs. 41 subjects for the study and all other analysis sets) due to 1 subject who discontinued prior to Week 12.|||Subjects|||Number
2780267|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months||||Weeks|Number of Surgeries|Standard Deviation|Mean
2780268|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.|||Weeks|Number of Surgeries|Full Range|Median
2780269|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.|||Weeks|Number of Surgeries|Standard Deviation|Mean
2780270|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had definitive surgery (either limb sparing or/and amputation), experienced neuropathic pain (NP) and were treated for NP until resolution of NP symptoms and off NP medications.|||Weeks|Number of Surgeries|Full Range|Median
2780271|NCT00667342|Other Pre-specified|Number of Participants With Neuropathic Pain (NP) Following Surgery|Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively.|Up to 6 months postoperatively||||participants|Number of Surgeries||Number
2780272|NCT00667342|Secondary|Difference Between Good and Poor Response by SUVmax|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|One participant with no histologic response but with evaluable imaging was excluded.|||(unitless)||Standard Error|Mean
2780273|NCT00667342|Secondary|P95 of Ktrans by Good and Poor Response|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.|||min(-1)||Standard Error|Mean
2780274|NCT00667342|Secondary|Ktrans by Good and Poor Response|The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.|||min(-1)||Standard Error|Mean
2780275|NCT00667342|Secondary|Histologic Response by Number of Participants|The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.|at week 10 after start of therapy|Two Stratum A participants with no histologic response were excluded.|||Participants|||Count of Participants
2780276|NCT00667342|Secondary|Mean Ve|The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points|||(unitless)||Standard Deviation|Mean
2780277|NCT00667342|Secondary|Mean Vp|The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points|||(unitless)||Standard Deviation|Mean
2780278|NCT00667342|Secondary|Mean Ktrans|The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.|Baseline through Week 10|The number analyzed at each time point differed due to missing observations at some of the time points|||min(-1)||Standard Deviation|Mean
2780279|NCT00667342|Secondary|2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 7 were expired and 24 still alive|||probability||95% Confidence Interval|Number
2780280|NCT00667342|Secondary|2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events.|||probability||95% Confidence Interval|Number
2780281|NCT00667342|Secondary|2-Year Overall Survival (OS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015.|||probability||95% Confidence Interval|Number
2780282|NCT00667342|Secondary|2-Year Event Free Survival (EFS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants were included in this analysis.|||probability||95% Confidence Interval|Number
2780283|NCT00667342|Secondary|Histologic Response by Stratum|"The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133.~Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor).~The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done."|After 6 cycles of chemotherapy, up to 1 year after the start of therapy|All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.|||participants|||Number
2780284|NCT00667342|Primary|3-Year Event Free Survival|To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.|After all patients have completed therapy, up to 4 years after last patient is enrolled||||Probability||95% Confidence Interval|Number
2780285|NCT00667342|Primary|Number of Participants With Unacceptable Toxicity|"Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma.~The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications.~A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity."|After all patients have completed therapy, up to 1 year after last patient is enrolled|Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.|||participants|||Number
2780286|NCT00667277|Secondary|Number of Cycles|Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle.|2 years||||cycles||Standard Deviation|Mean
2780287|NCT00667277|Primary|Reason for Therapy Discontinuation|"Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.~The two subjects who withdrew consent prior to initiation of therapy are included in the patient refusal category."|2 years||||participants|||Number
2780288|NCT00667251|Secondary|Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization||Not available at this time|||||||
2780289|NCT00667251|Secondary|Effects of Changes in Biomarkers on Clinical Outcomes||Not available at this time|||||||
2780290|NCT00667251|Secondary|Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life. At 12 weeks: Group mean difference between arms|12 weeks||||Score on global scale||Standard Deviation|Mean
2780291|NCT00667251|Secondary|Clinical Benefit Response Rate (HER2/Neu+))|Best overall response of CR, PR, or stable disease at end of week 24.|24 weeks||||Participants|||Number
2780292|NCT00667251|Secondary|Clinical Benefit Response Rate (ITT)|Best overall response of CR, PR or stable disease at end of week 24.|24 weeks||||Participants|||Number
2780293|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) HER2/Neu+|Response determined by RECIST V 1.0|Median follow-up of 21.5 months.||||Participants|||Number
2780294|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) ITT|Patients included in this assessment must have had at least one measurable lesion at baseline, and had at least one RECIST re-evaluation after baseline while on protocol therapy, prior to, or on, date of progression. Best overall response was classified to be Complete Response (CR) or Partial Response (PR).|4 years||||Participants|||Number
2780295|NCT00667251|Secondary|CNS Metastases at the Time of Progression (HER2+)||Incidence rate of CNS mestastes at first progression, assessed up to 39 months|151 patients with metastases assessed for CNS metastases; 128 patients with metastases assessed for CNS metastases.|||CNS metastases|||Number
2780299|NCT00667251|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From randomization to RECIST V 1.0 progression or death assessed up to 39 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)|||Months||Full Range|Median
2780300|NCT00667225|Secondary|Mean Change in Each Group Measured by Lesion Count.|Average change in number of lesions from baseline to 8 weeks|Baseline compared to 8 weeks (5 visits)||||lesions||Standard Deviation|Mean
2780301|NCT00667225|Primary|Patients Experiencing Complete Clearance of All Molluscum Lesions.||Baseline compared to 8 weeks (5 visits)|We used a power calculation to estimate the number of patients needed to detect a clinically significant result.|||Participants|Participants||Number
2780302|NCT00667186|Secondary|Percentage Consenting to Testing|Percentage of those successfully offered testing who consent to testing|3 years|the number consenting to testing divided by the number offered testing|||percentage of offered testing who consen|||Number
2780303|NCT00667186|Primary|Percentage of Tested Participants Newly Diagnosed as HIV Infected|Percentage of tested participants newly diagnosed as HIV infected|3 years|participants analyzed is restricted to the participants that consented to testing|||percentage of tested that are positive|||Number
2780304|NCT00667095|Secondary|Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months|"Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||participants|||Number
2780305|NCT00667095|Secondary|Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||participants|||Number
2780306|NCT00667095|Secondary|Change in Urogenital Distress Inventory (UDI-6)|"The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
2780307|NCT00667095|Secondary|Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)|The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
2780308|NCT00667095|Secondary|Change in Incontinence Impact Questionnaire Short Form (IIQ-7)|"The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
2780309|NCT00667095|Primary|Change in Incontinence Quality of Life (I-QoL) Score|"The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'.~A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life."|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).|||units on a scale||Standard Deviation|Mean
2780310|NCT00667017|Primary|Response Rate - Cutaneous T Cell Lymphoma (CTCL)|Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.|Once a week for seven weeks|Consent Withdrawn After Treatment Started Pt withdrew from treatment due to side effects.||||||
2780311|NCT00666978|Secondary|Number of Slow and Fast Metabolizers by Genotype|"Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.~Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are *1/*1 genotype by exclusion."|Week 0|This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm. Blood was unable to be analyzed for CYP2A6 genotype for 6 participants.|||Participants|||Count of Participants
2780313|NCT00666978|Secondary|Number of Slow and Fast Metabolizers by Metabolite Ratio|"Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.~The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.~Blood samples were collected for 3HC/COT ratio at Week 0."|Weeks 0|This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.|||Participants|||Count of Participants
2780314|NCT00666978|Primary|Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months|Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.|6 months||||Participants|||Count of Participants
2780315|NCT00666965|Secondary|IRLS Each Parameter|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.~The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF|||Percentage of Participants|||Number
2780316|NCT00666965|Secondary|Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)|Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2780317|NCT00666965|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates no difficulty and 21 indicates severe difficulty. A decrease in the scores means improvement.~The data at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF|||Percentage of Participants|||Number
2780318|NCT00666965|Secondary|Patient Global Impression (PGI) Improvement|The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7.|Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF|||Percentage of Participants|||Number
2780319|NCT00666965|Secondary|Clinical Global Impression (CGI) Severity|"CGI is a clinician-reported scale for assessing severity of illness.~The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients."|Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF|||Percentage of Participants|||Number
2780320|NCT00666965|Primary|Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score.~The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, end of maintenance period at 6 weeks|Full analysis set (FAS), last observation carried forward (LOCF)|||scores on a scale||Standard Deviation|Mean
2780321|NCT00666926|Secondary|Caspase-3|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; sequential activation of caspases plays a central role in the execution-phase of cell apoptosis. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
2780322|NCT00666926|Secondary|Phospho-SRC (pSRC)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; SRC proto-oncogenes are regulators of growth and differentiation of eukaryotic cells and are implicated in development of human tumors. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose; on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
2780323|NCT00666926|Secondary|Phosphorylated Mitogen Activated Pathway Kinase (pMAPK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; MAPK regulates activities of several transcription factors. A defect in MAPK pathway leads to uncontrolled cell growth. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
2780445|NCT00666406|Secondary|Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
2780324|NCT00666926|Secondary|Phosphorylated Focal Adhesion Kinase (pFAK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; FAK is overexpressed in a variety of human cancers. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.||||||
2780325|NCT00666926|Secondary|Percentage of Participants With Best Overall Response as Measured Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment (Tx) until disease progression. Complete response: disappearance of all target lesions. Partial response: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD. Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions. Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Baseline up to 12 cycles (cycle=21days)|RECIST response analysis set: all enrolled participants who had an adequate baseline tumor assessment, measureable disease and who started treatment. N=number of participants with evaluable data at observation.|||percentage of participants|||Number
2780326|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): MDZ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2780327|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): MDZ|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||hours||Standard Deviation|Mean
2780328|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||hours||Full Range|Median
2780329|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): MDZ|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2780330|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): MDZ|Area under the serum concentration time-curve from zero to the last measured concentration.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2780331|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2780332|NCT00666926|Secondary|Observed Accumulation Ratio (Rac): PF-00562271 C1.D14|Rac was the ratio of the Day 14 AUC0-tau (0 hour to last dose interval) and AUC during the corresponding time period after the lead-in dose (AUCtau C1.D14/AUCtau C0.D1).|Escalation (Esc) cohort: C0.D1: 0 hr, and 0.5, 1, 2, 4, 6, 7,12 hrs post dose; Expansion (Exp) cohort: C0:D1: 0 hr, and 1, 2, 4, 8 hrs post dose; Esc and Exp cohorts: C1.D14 0 hour, and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2780333|NCT00666926|Secondary|Area Under the Curve From Time Zero to the End of the Dosing Interval (AUCtau): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2780334|NCT00666926|Secondary|Minimum Observed Serum Trough Concentration (Cmin): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2780335|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2780446|NCT00666406|Secondary|Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Increase in factor VIII concentration from pre- to post-infusion.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
2780336|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||hours||Standard Deviation|Mean
2780337|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2780338|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1|Area under the serum concentration time-curve from zero to the last measured concentration; nanograms multiplied by hours per milliliters (ng*hr/mL).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2780339|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||hours||Full Range|Median
2780340|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||hours||Full Range|Median
2780341|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2780342|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose|Pharmacokinetic (PK) parameter analysis set: all participants with at least 1 dose of study treatment and at least 1 of the PK parameters of interest estimated in at least 1 treatment period. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2780343|NCT00666926|Primary|Percentage of Participants With Tumor Metabolic Response (Reduction of ≥15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|Metabolic response demonstrated in any tumor reduction of ≥15% in tumor FDG standardized uptake value (SUV) in Cycle 1; based on the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Participant must have had a baseline PET with at least 1 tumor lesion demonstrating an FDG SUV of ≥5.|Baseline, C1.D14|Participants in the 125 mg BID expansion cohort with at least 1 dose of study treatment, at least 1 lesion with an SUV ≥5 at baseline, and an on-study PET assessment C1.D14 (Day 13 up to Day 17).|||percentage of participants||90% Confidence Interval|Number
2780344|NCT00666926|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or Gr 3 febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); Gr ≥3 non-hematologic toxicity despite adequate medical intervention; Gr ≥3 confirmed prolonged QTc interval (>500 milliseconds [msec]); confirmed cardiac troponin I ≥99 percentile of reference range; Tx related toxicities with failure to receive ≥18 days Tx in 21-day cycle or inability to resume current dose level ≤14 days.|Baseline up to Cycle 1 Day 21 (C1.D21)|Safety analysis set: All enrolled participants who started treatment.|||participants|||Number
2780345|NCT00666848|Primary|Change in MAP During Sitagliptin|Mean change in mean arterial pressure in response to placebo or enalapril in the presence of 5 days of sitagliptin 100mg/day|just prior to drug administration and 8 hours following treatment||||mmHg||Standard Deviation|Mean
2780346|NCT00666848|Primary|Change in MAP During Placebo|The change in mean arterial pressure (MAP) in response to placebo or enalapril after pretreatment with 5 days of placebo|just prior to drug administration and 8 hours after drug administration||||mmHg||Standard Deviation|Mean
2780347|NCT00666835|Secondary|Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population|The mean absolute change in Hb levels between the screening/baseline period and the evaluation period was analyzed for the intent-to-treat (ITT) population in the same way as the primary efficacy endpoint. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between HX575 epoetin alfa Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL].|28 weeks|Intent-to-treat population (ITT): all randomized patients who received at least one dose of the study medication and for whom at least one post-baseline value of the primary endpoint Hb was available. A prerequisite to be included in the ITT population was that they were treated for four weeks with Hb values available during this period.|||g/dL||Standard Error|Least Squares Mean
2780348|NCT00666835|Primary|To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.|Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval [-0.5 g/dL; 0.5 g/dL]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.|28 weeks|Primary Endpoint was analyzed based on ITT population: all treated patients with a post baseline hemoglobin value.|||g/dL||Standard Error|Least Squares Mean
2780349|NCT00666757|Secondary|Change From Baseline in Weight at Week-12 Endpoint|Mean change from baseline to endpoint in weight|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284|||kilograms (kg)||Standard Error|Least Squares Mean
2780350|NCT00666757|Secondary|Change From Baseline in Pulse Rate at Week-12 Endpoint|Mean change from baseline to endpoint in pulse rate|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285|||beats per minute (bpm)||Standard Error|Least Squares Mean
2780351|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint|"Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported."|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.|||units on a scale||Standard Error|Least Squares Mean
2780352|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint|Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.|||hours lost per week||Standard Error|Least Squares Mean
2780353|NCT00666757|Secondary|Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in diastolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285|||mmHg||Standard Error|Least Squares Mean
2780354|NCT00666757|Secondary|Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in systolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285|||millimeters of mmercury (mmHg)||Standard Error|Least Squares Mean
2780355|NCT00666757|Secondary|Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
2780356|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
2780357|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint|Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100-absenteeism] × [100-presenteeism]). Mean change baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Last Observation Carried Forward.|||dollars||Standard Error|Least Squares Mean
2780358|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint|WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.|||dollars||Standard Error|Least Squares Mean
2780359|NCT00666757|Secondary|Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192|||units on a scale||Standard Error|Least Squares Mean
2780360|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
2780361|NCT00666757|Secondary|Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257|||units on a scale||Standard Error|Least Squares Mean
2780362|NCT00666757|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166|||units on a scale||Standard Error|Least Squares Mean
2780363|NCT00666757|Secondary|Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285|||units on a scale||Standard Error|Least Squares Mean
2780364|NCT00666757|Secondary|Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
2780365|NCT00666757|Secondary|Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
2780366|NCT00666757|Secondary|Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)|"HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe)."|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
2780367|NCT00666757|Secondary|Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
2780368|NCT00666757|Secondary|Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283|||units on a scale||Standard Error|Least Squares Mean
2780369|NCT00666757|Secondary|Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283|||Probability of response||Standard Error|Least Squares Mean
2780447|NCT00666406|Secondary|Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
2780370|NCT00666757|Secondary|Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||Probability of response||Standard Error|Least Squares Mean
2780371|NCT00666757|Secondary|Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]|Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.|12 weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283|||Probability of remission||Standard Error|Least Squares Mean
2780372|NCT00666757|Secondary|Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)|The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||units on a scale||Standard Error|Least Squares Mean
2780373|NCT00666757|Primary|Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]|Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.|12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284|||Probability of remission||Standard Error|Least Squares Mean
2780374|NCT00666718|Secondary|Number of Injections of Insulin at Week 24||Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Participants|||Number
2780375|NCT00666718|Secondary|Total Daily Insulin Dose at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Units||Standard Error|Least Squares Mean
2780376|NCT00666718|Secondary|Change in Body Weight From Baseline to Week 24|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.|||Kilograms (kg)||Standard Error|Least Squares Mean
2780377|NCT00666718|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is located in the Reported Adverse Event module.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.|||participants|||Number
2780378|NCT00666718|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes|Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.|||percentage of participants|||Number
2780379|NCT00666718|Secondary|Rate Of All Self-reported Hypoglycemic Episodes|Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.|||episode/30 days/participant||Standard Error|Least Squares Mean
2780380|NCT00666718|Secondary|Glycemic Variability at Endpoint|LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||mmol/L||Standard Error|Least Squares Mean
2780381|NCT00666718|Secondary|7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.|24 weeks|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2780382|NCT00666718|Secondary|Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint||Week 24|Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Percent of Participants|||Number
2780383|NCT00666718|Secondary|Change From Baseline in HbA1c at Week 12 and Week 24|LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.|Baseline, Week 12, Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||Percent of Glycosylated Hemoglobin||95% Confidence Interval|Least Squares Mean
2780384|NCT00666718|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24|Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.|||Percent of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2780385|NCT00666705|Other Pre-specified|Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
2780386|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
2780387|NCT00666705|Other Pre-specified|Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
2780388|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng.hr/mL||Standard Deviation|Mean
2780389|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
2780390|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.|||ng.hr/mL||Standard Deviation|Mean
2780391|NCT00666679|Post-Hoc|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average.|Baseline and 2 Weeks|The analysis was based on a subset of the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug, had a measurement for analysis available in at least one treatment period and met lung function eligibility criteria specifically at the randomization visit.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2780545|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780392|NCT00666679|Other Pre-specified|Change From Baseline in Total Peripheral Blood Eosinophils|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||10^3/microliter||95% Confidence Interval|Least Squares Mean
2780393|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Exacerbations|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period.|2 Weeks|The analysis was based on the Completers Set population which included all randomized patients who took a dose of blinded post randomization study drug (inhaled montelukast or matching placebo) in both treatment periods and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2780394|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Control|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2780395|NCT00666679|Other Pre-specified|Change From Baseline in Total Daily β-agonist Use|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||Puffs||95% Confidence Interval|Least Squares Mean
2780396|NCT00666679|Secondary|Change From Baseline in Nighttime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on a subset of the FAS population which included all randomized patients with nighttime symptoms at baseline (score>0), who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2780397|NCT00666679|Secondary|Change From Baseline in Daytime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2780398|NCT00666679|Primary|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2780399|NCT00666666|Secondary|Percentage of Patients With Overall PSA < 4.0 ng/mL||3 years||||percentage of participants|||Number
2780400|NCT00666666|Secondary|Percentage of Patients With PSA ≥ 0.2 ng/mL But < 4.0 ng/mL||3 years||||percentage of participants|||Number
2780401|NCT00666666|Primary|Percentage of Patients With Undetectable Prostate-specific Antigen (PSA) (< 0.2 ng/mL) at End of 7 Cycles||3 years||||percentage of participants|||Number
2780402|NCT00666588|Secondary|Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion|Descriptive statistics to assess mean +/- standard deviation for the percentage leukemia initiation cells (LIC) depletion.|At baseline and after completion of course 1|Ineligible patients (n=4) are excluded. Patients without available data (n=42) are excluded.|||percentage of LIC depletion||Standard Deviation|Mean
2780403|NCT00666588|Secondary|Protein Expression Assessed by Western Blot|Relative expression of apoptotic and cell cycle proteins will be characterized using descriptive statistics. If differences are noted between pre and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test if the data are non-normally distributed. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|At baseline, prior to and up to 24 hours after bortezomib treatment|These data will never be collected because the investigators decided not to perform quantitative biologic analysis.||||||
2780404|NCT00666588|Secondary|Proteasome Inhibition Activity|Mean and standard deviation of β1 and β5- Results are ratios (proteasome subunit/β-actin based on loading of 15 µg total protein, normalized to CEM).|At baseline|Ineligible patients (n=4) are excluded. Patients without available data (n=36) are excluded. The data summarized are only at baseline as that is the only data available.|||ratio||Standard Deviation|Mean
2786526|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose DBP <90 mmHg.|6 months and 12 months|FAS|||percentage of participants|||Number
2780405|NCT00666588|Secondary|NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)|NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response.|At baseline, prior to and up to 24 hours after bortezomib treatment|Ineligible patients (n=4) are excluded. Patients without available data (n=36) are excluded.|||ng/Mg protein||Standard Deviation|Mean
2780406|NCT00666588|Primary|Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1|Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1.|After course 1||||participants|||Number
2780407|NCT00666588|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity.|During Course 1||||participants|||Number
2780408|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)||At Baseline|This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed for 4 participants.|||ng/mL||Standard Deviation|Mean
2780409|NCT00666562|Secondary|Absolute Change for Baseline of EGCG in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
2780410|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
2780411|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
2780412|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples||up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 2 participants in Arm III.|||ng/mL||Standard Deviation|Mean
2780413|NCT00666562|Secondary|Serum IGFBP-3 Levels Assessed by ELISA||Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I.|||ng/mL||Standard Deviation|Mean
2780414|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)||At Baseline|"This outcome was assessed in all participants,combined irrespective of their randomization.~Analysis was not able to be completed on 4 participants."|||ng/mL||Standard Deviation|Mean
2780415|NCT00666562|Secondary|Absolute Change for Baseline From EGCG in Serum Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.|||ng/mL||Standard Deviation|Mean
2780416|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.|||ng/mL||Standard Deviation|Mean
2780417|NCT00666562|Secondary|Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA||Baseline and up to day 28|Analysis was not able to be completed for 2 participants in Arm I.|||ng/mL||Standard Deviation|Mean
2780418|NCT00666562|Secondary|Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry||up to 28 days||||optical density||Standard Deviation|Mean
2780419|NCT00666562|Secondary|Levels of EGCG in Malignant Bladder Tissue||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.|||ng/mL||Standard Deviation|Mean
2780420|NCT00666562|Primary|Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)|Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.|up to 28 days||||ng/mL||Standard Error|Mean
2780421|NCT00666536|Secondary|Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||Percentage of Patients|||Number
2780422|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSDBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
2780423|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSSBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
2780424|NCT00666536|Secondary|Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
2780425|NCT00666536|Secondary|Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||Percentage of Patients|||Number
2780426|NCT00666536|Primary|Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
2780427|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.|||mmol/L||Standard Error|Mean
2780428|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
2780429|NCT00666458|Secondary|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)|Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.|||Percentage of Participants|||Number
2780430|NCT00666458|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 18|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline, Week 18|Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.|||Percent||Standard Error|Mean
2780431|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
2780432|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
2780433|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted Clearance (CL) * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
2780434|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed as weight-adjusted Clearance * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/kg||90% Confidence Interval|Geometric Mean
2780435|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780436|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780437|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780438|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780439|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780440|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780441|NCT00666406|Secondary|Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780442|NCT00666406|Secondary|Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||Hours||90% Confidence Interval|Geometric Mean
2780443|NCT00666406|Secondary|Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
2780444|NCT00666406|Secondary|Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
2790698|NCT00589472|Secondary|Levels of DHEA in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/dL||95% Confidence Interval|Median
2780448|NCT00666406|Secondary|Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
2780449|NCT00666406|Secondary|Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
2780450|NCT00666406|Secondary|Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations (9 to 48 hours).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||hours||90% Confidence Interval|Geometric Mean
2780451|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
2780452|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
2780453|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
2780454|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU/dL||90% Confidence Interval|Geometric Mean
2780455|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
2780456|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
2780457|NCT00666406|Secondary|Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
2780458|NCT00666406|Secondary|Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||mL/h/kg||90% Confidence Interval|Geometric Mean
2780459|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780460|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780461|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780462|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|"AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.~FVIII activity measurement"|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780463|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780492|NCT00666263|Secondary|Rate of Related SAEs Per Infusion|The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||SAEs per infusion|Infusions||Number
2780464|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780465|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780466|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants|||IU*h/dL||90% Confidence Interval|Geometric Mean
2780467|NCT00666328|Secondary|The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion||Within 30 minutes of the initiation of study drug infusion|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.|||percent participants|||Number
2780468|NCT00666328|Secondary|Percent Change in Heart Rate During 30 of Initiation of Clevidipine|Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes.|From study drug initiation through each specified timepoint|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. Data for 33 of the 35 patients in the Safety population had data for the 30 minute time point used for this analysis.|||percent change||Standard Deviation|Mean
2780469|NCT00666328|Secondary|Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine|Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study.|Up to 96 hours|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.|||participants|||Number
2780470|NCT00666328|Secondary|Median Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours||||milligrams (mg)||Inter-Quartile Range|Median
2780471|NCT00666328|Secondary|Mean Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.|||milligrams (mg)||Standard Deviation|Mean
2780472|NCT00666328|Secondary|Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine|The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations >24 hours across patients.|From study drug initiation through termination (up to 96 h)|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.|||percent time||Standard Deviation|Mean
2780473|NCT00666328|Secondary|Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion|Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range.|Duration of the study drug infusion (up to 96 hours)||||mm Hg × min/hr||Standard Deviation|Mean
2780474|NCT00666328|Secondary|Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion|Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period.|Baseline through 30 minutes post initiation of clevidipine infusion||||percent change in SBP||Standard Deviation|Mean
2780475|NCT00666328|Secondary|Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine|The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.|||percent participants||95% Confidence Interval|Number
2780476|NCT00666328|Primary|Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine|The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.|||minutes||95% Confidence Interval|Median
2780477|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.|Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780478|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.|Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780479|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Weight.|Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780480|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Route of Administration.|Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780481|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.|Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780482|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.|Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780483|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.|Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780484|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Age|Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780485|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Gender.|Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780486|NCT00666276|Primary|Number of Participants With Adverse Drug Reactions(ADRs).|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780487|NCT00666276|Primary|Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.|The adverse drug reaction that have not been listed in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
2780488|NCT00666263|Primary|The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion||Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||percentage of participants|||Number
2780489|NCT00666263|Secondary|The Proportion of Infusions Associated With One or More AEs Related to the Study Product||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||proportion of infusions|Infusions||Number
2780490|NCT00666263|Secondary|The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||proportion of infusions|Infusions||Number
2780491|NCT00666263|Secondary|The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||proportion of participants|||Number
2780493|NCT00666263|Secondary|Rate of Related AEs Per Infusion|The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||AEs per infusion|Infusions||Number
2780494|NCT00666263|Primary|The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||percentage of infusions|Infusions||Number
2780495|NCT00666263|Primary|The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||percentage of participants|||Number
2780496|NCT00666263|Primary|Rate of Temporally Associated Adverse Events (AEs) Per Infusion|The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.|Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset|||Percentage of AEs per infusion|Infusions||Number
2780497|NCT00666263|Primary|Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Proportion of participants|||Number
2780498|NCT00666263|Post-Hoc|Proportion of Participants With at Least a 30% Decline in Relative Grip Strength in the Less Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Proportion of participants|||Number
2780499|NCT00666263|Primary|Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
2780500|NCT00666263|Secondary|Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents no symptoms and 10 disabled, unable to use affected limbs."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in assessment||95% Confidence Interval|Mean
2780501|NCT00666263|Secondary|Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|"The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents no symptoms and 10 disabled, unable to use affected limbs."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
2780502|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in time||95% Confidence Interval|Mean
2780503|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Seconds||Inter-Quartile Range|Median
2780523|NCT00666211|Primary|Pain-related Distress|Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).|Baseline(Week 0) to week 8, Total time frame is 9 weeks.||||units on a scale||Standard Deviation|Mean
2780546|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780504|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in time||95% Confidence Interval|Mean
2780505|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Seconds||Inter-Quartile Range|Median
2780506|NCT00666263|Secondary|Mean Relative Change in Overall Disability Sum Score|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, no signs of disability to 12, most severe disability). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||percent change in score||95% Confidence Interval|Mean
2780507|NCT00666263|Secondary|Overall Disability Sum Score - Standardized|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).~This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
2780508|NCT00666263|Secondary|Overall Disability Sum Score|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability.~Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability)."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
2780509|NCT00666263|Secondary|Patient Global Impression of Change|"Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)).~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||Scores on a scale||Inter-Quartile Range|Median
2780510|NCT00666263|Secondary|Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)|Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.|During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Intent to treat|||Proportion of participants|||Number
2780511|NCT00666263|Secondary|Mean Relative Change in Grip Strength in the Less Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in grip strength||95% Confidence Interval|Mean
2780512|NCT00666263|Secondary|Grip Strength in the Less Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.~Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||kilograms||Inter-Quartile Range|Median
2780544|NCT00665925|Secondary|Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2794921|NCT00556933|Secondary|Lymphoid Cell Sub-type CD3 Absolute Numbers||One year||||CD3 Cell Numbers/mm^3||Standard Deviation|Mean
2780513|NCT00666263|Secondary|Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percentage of participants|||Number
2780514|NCT00666263|Primary|Mean Relative Change in Grip Strength in the More Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat|||Percent change in grip strength||95% Confidence Interval|Mean
2780515|NCT00666263|Primary|Grip Strength in the More Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.~Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat|||kilograms||Inter-Quartile Range|Median
2780516|NCT00666224|Secondary|Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set.|||percentage of total participants|||Number
2780517|NCT00666224|Primary|Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Due to the number of participants in the glatiramer acetate group that converted to CDMS (see outcome #6), the 25th percentile was considered when running the Kaplan-Meier estimate for time to conversion to CDMS. Conversion to CDMS is determined by the occurrence of the second clinical attack.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.|||days||95% Confidence Interval|Number
2780518|NCT00666224|Secondary|Percentage Change in Brain Volume From Baseline to the Last Observed Value (LOV) During the Double-blind Period Using the Structural Image Evaluation of Normalized Atrophy (SIENA) Technique|Data from interim analysis with database lock on October 14, 2007. Brain volume was measured annually by magnetic resonance imaging (MRI) during the Double-blind period. Brain atrophy was measured by comparing the change in brain volume from baseline to the Last Observed Value (LOV). LOV is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation. SIENA is a fully automated method of analyzing longitudinal brain change.|Day 0 (baseline), up to 3 years|Intent to treat population of participants with both baseline and last observed values.|||percent change||Standard Deviation|Mean
2780519|NCT00666224|Secondary|Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. The difference in T2 brain lesion volume as observed in MRIs from baseline to the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|Day 0 (baseline), up to 3 years|Intent to treat population for which data at both timepoints are available|||ml||Standard Deviation|Mean
2780520|NCT00666224|Secondary|Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. T2 lesions are brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. This outcome measures the number of new lesions at the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.|||new T2 lesions||Standard Deviation|Mean
2780521|NCT00666224|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion|Data from interim analysis with database lock on October 14, 2007. The time from randomization to conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.|||days||Standard Deviation|Mean
2780522|NCT00666211|Primary|Pain Duration|Pain duration in hours 0 to 24|at 9 weeks||||hours||Standard Deviation|Mean
2780718|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 2 (Up to 72 weeks)|All subject enrolled in Step 2.|||participants|||Number
2780524|NCT00666211|Secondary|Quality of Life|Each patient in each arm is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) at baseline + week 8 with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded & items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).|9 weeks||||scores on a scale||Standard Deviation|Mean
2780525|NCT00666211|Secondary|Mood Disturbance|Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.|9 weeks||||units on a scale||Standard Deviation|Mean
2780526|NCT00666211|Secondary|Interference in Daily Life Due to Pain|Patients in each arm will each have 5 measures on the Brief Pain Inventory (BPI) scale: baseline + weeks 2, 4, 6, 8. The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average from the 7 questions, with higher score indicating greater interference due to pain.|9 weeks||||units on a scale||Standard Deviation|Mean
2780527|NCT00666211|Secondary|Ability to Engage in Activities of Daily Living (ADL)|The Functional Assessment Screening Questionnaire (FASQ) scale is used, scored at baseline and at weeks 2, 4, 6, 8. The FASQ consists of 15 questions about ability to perform ADL with minimum score of 1 (easy to perform) to a maximum score of 5 (N/A, meaning someone else performs this activity for the patient or else the patient chooses not to do it). A summary mean score is generated with a minimum score of 1 and a maximum score of 5.|Baseline(Week 0) to week 8, Total time frame is 9 weeks.||||units on a scale||Standard Deviation|Mean
2780528|NCT00666211|Primary|Pain Intensity|"Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8:~Average daily pain intensity 0 (no pain) to 10 (worst) scale~Worst daily pain intensity 0 (no pain) to 10 (worst) scale"|Baseline(Week 0) to week 8, Total time frame is 9 weeks.||||units on a scale||Standard Deviation|Mean
2780529|NCT00666198|Primary|Clinical Efficacy Rate by WHO Functional Classificaton of Severity|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as effective, ineffective or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links) were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
2780530|NCT00666198|Primary|Clinical Efficacy Rate by Disease Type|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as effective, ineffective or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness.~* indicates Associated Pulmonary Arterial Hypertension (APAH). ** refers to Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
2780531|NCT00666198|Primary|Clinical Efficacy Rate by Gender|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as effective, ineffective or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
2780532|NCT00666198|Primary|Clinical Efficacy Rate by Age|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as effective, ineffective or unassessable by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness."|3 years|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician/investigator based upon change in clinical symptoms and laboratory findings) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants|||Number
2790573|NCT00590460|Secondary|Patients With Limited Chronic GVHD From Day 100 to 365|Number of patients with limited chronic GVHD from day 100 to 365|365 days||||participants|||Number
2780533|NCT00666198|Primary|Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH) to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
2780534|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events by Disease Type|"A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events.~* indicates Associated Pulmonary Arterial Hypertension (APAH). ** refers to Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis."|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
2780535|NCT00666198|Primary|Number of Paritcipants With Treatment-Related Adverse Events by Gender|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Paritcipants|||Number
2780536|NCT00666198|Primary|Number of Paritcipants With Treatment-Related Adverse Events by Age|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Paritcipants|||Number
2780537|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
2780538|NCT00666198|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received sildenafil citrate at least once.|||Participants|||Number
2780539|NCT00666029|Primary|Insulin Sensitivity Index|Insulin sensitivity index was assessed during the final steady state 30 minutes of a high dose hyperinsulinaemic euglycaemic clamp (insulin infusion rate 1.5 mIU/kg/min). During this part of the clamp, insulin was infused at 1.5mIU/kg/min and the glucose concentration was maintained at 5 mmol/L using a dextrose infusion. The whole body insulin mediated glucose disposal rate (M value - mg/kg/min) was estimated from the total amount of glucose infused during the last 30 minutes of the clamp. The mean of four serum insulin concentrations was taken during this 30 minutes to determine the steady state insulin concentration (I value - milliunits/litre). M value/I value defined the insulin sensitivity index.|6 months|There was missing data in four people in the atorvastatin arm and two people in the placebo arm|||mg*kg^-1*min^-1*mIU^-1*L^-1||Standard Deviation|Mean
2780540|NCT00666029|Primary|Muscle Microvascular Function|Skeletal muscle microvascular function assessed (Filtrass plethysmographic system) using a passive inductive transducer (Compumedics.dwl, Singen, Germany) and a small pressure step venous congestion protocol. Fluid filtration rate (Jv mL min-1 100 mL-1), measured from the slope of limb volume change in response to each pressure step (10 mmHg steps to 60 mmHg around the thigh) over the last 2 minutes of its application, to allow for completion of vascular filling, and plotted against cuff pressure (Pcuff). The slope of this relationship, at pressures above those giving rise to net filtration, is a measure of Kf, microvascular filtration capacity, a function of exchange surface area and permeability. The CV for Kf measurement was 14.5%.|6 months|There was missing data on two participants in the atorvastatin arm and two participants in the placebo arm.|||10^3 mL*min^-1*100ml^-1*mmHg^-1||Standard Deviation|Mean
2780541|NCT00665925|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC (a test of liver function) values lower than 1500/mm3|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780542|NCT00665925|Secondary|Bilirubin >2 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780543|NCT00665925|Secondary|Bilirubin >1.5 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780547|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780548|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780549|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780550|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780551|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780552|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780553|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780554|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780555|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780556|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780557|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780558|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780559|NCT00665925|Secondary|Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months|Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780560|NCT00665925|Secondary|Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months|Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780561|NCT00665925|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months|Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.|Baseline to 6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780562|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780563|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780564|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780565|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780566|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780567|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780568|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780569|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780570|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780571|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780572|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780573|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780574|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780575|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780576|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780592|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Month|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 month of treatment|1 month|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780577|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780578|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780579|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780580|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780581|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780582|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780583|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780584|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780585|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.|||Participants|||Number
2780586|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 months of treatment|6 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780587|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 5 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 5 months of treatment|5 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780588|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 4 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 4 months of treatment|4 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780589|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780590|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 months of treatment|2 months|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780591|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 weeks of treatment|6 weeks|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780593|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 weeks of treatment|2 weeks|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780594|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Week|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 week of treatment|1 week|Intent-to-treat population with available data and received study drug.|||Score||Standard Deviation|Mean
2780595|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780596|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 5 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780597|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 4 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780598|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780599|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780600|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780601|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Month|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780602|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780603|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Week|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780604|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780605|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 5 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780606|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 4 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780632|NCT00665704|Primary|Self Reported 30 Day Smoking Quit Rate|Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.|30 days post intervention||||participants|||Number
2780607|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780608|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780609|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780610|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Month|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780611|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780612|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Week|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780613|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 5 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780614|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 4 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780615|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780616|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780617|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 6 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780618|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Month|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780619|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780633|NCT00665652|Primary|Change in Total Neuropathy Score in Subjects With MGUS Associated Neuropathy After Treatment With Lenalidomide.|"Minimum value of the Total Neuropathy Score is 0, maximum value is 40. A higher score represents a worsening."|Baseline, 12 months|Subjects were evaluable if they were on study drug for 3 months.|||units on a scale||Full Range|Mean
2780620|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Week|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.|||Participants|||Number
2780621|NCT00665925|Primary|American College of Rheumatology 20 (ACR20) Response at 6 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population includes all subjects that received study drug|||Participants|||Number
2780622|NCT00665847|Secondary|The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures|Virologic failure (lack of response) was defined as: plasma viral load decline of < 0.5 log10 from Baseline by Week 8 and/or plasma viral load decline of <1.0 log10 from Baseline by Week 12. Virologic failure (loss of response) was defined as 2 consecutive measurements of plasma viral load > 0.5 log10 above the nadir after a minimum of 12 weeks of treatment. The table below provides data for 41 viologic failures of which 30 had mutation data available. In the table below, only the 4 most frequently emerging mutations are presented (emerging in at least 3 patients).|Baseline and Endpoint (up to Week 48)|The patients in the intent-to-treat (ITT) population classified as virologic failures were used for this analysis.|||Patients|||Number
2780623|NCT00665847|Secondary|The Change From Baseline in CD4 Cell Counts Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||10E6 cells/L||Standard Error|Mean
2780624|NCT00665847|Secondary|Change From Baseline in Human Immunodeficiency Virus - Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||log10 copies/mL||Standard Error|Mean
2780625|NCT00665847|Secondary|Percentage of Patients With Virologic Response at Week 24|Virologic response was defined as the percentage of patients with plasma viral load < 50 copies/mL at Week 24 calculated according to the non-completer=failure (NC=F) imputation method.|Week 24|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||Percentage of Patients|||Number
2780626|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)|Etravirine/TMC125 (ETR) Cmax was approximated for each individual using the median value of plasma ETR concentrations taken 4 hours postdose (± 1 hour), when available, on the day of the Week 4 visit as shown in the table below.|Week 4|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.|||ng/mL||Standard Deviation|Mean
2780627|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)||Week 48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."|||ng/mL||Standard Deviation|Mean
2780628|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)|The AUC12h is a Bayesian estimation based on a population pharmacokinetic model and sparse samples collected at each visit over the duration of trial. For each sparse sample taken, the time blood sample was recorded as well as the time of etravirine intake just prior to the time of blood sample.|Weeks 4-48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."|||ng.h/mL||Standard Deviation|Mean
2780629|NCT00665847|Primary|The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)|The percentage of patients with a treatment-emergent adverse event (TEAE) (defined as an event that occurred in the 48-week treatment period during which it emerged [i.e. started or worsened in severity, relation, or other attribute], and not in the subsequent study periods, even if the event continued to be present] are provided below. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.|||Percentage of patients|||Number
2780630|NCT00665847|Primary|The Number of Patients With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.|||Patients|||Number
2780631|NCT00665704|Secondary|Patient Feedback to Evaluate the Website|Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction. For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.|30 days post intervention||||participants|||Number
2790574|NCT00590460|Secondary|Number of Patients Alive at 1 Year Post Transplant|Number of patients alive at 1 year post allogeneic stem cell transplant|1 year||||participants|||Number
2780637|NCT00665626|Secondary|Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780638|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780639|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780640|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780641|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780642|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780643|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780644|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780645|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780646|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780647|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780648|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780649|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780650|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780651|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population|||Participants|||Number
2780652|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months|Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.|||Score||Standard Deviation|Mean
2780653|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months|Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.|||Score||Standard Deviation|Mean
2780654|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months|Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.|||Score||Standard Deviation|Mean
2780655|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 2|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks|2 weeks|Intent-to-treat population|||Participants|||Number
2780719|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 1 (Up to 24 to 28 weeks)|All enrolled subjects.|||participants|||Number
2780656|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 1|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.|1 week|Intent-to-treat population|||Participants|||Number
2780657|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant|||Participants|||Number
2780658|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant|||Participants|||Number
2780659|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant|||Participants|||Number
2780660|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant|||Participants|||Number
2780661|NCT00665626|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population|||Score||Standard Deviation|Mean
2780662|NCT00665626|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population|||Participants|||Number
2780663|NCT00665626|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population|||Participants|||Number
2780664|NCT00665626|Primary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months|3 months|Intent-to-treat population|||Participants|||Number
2780665|NCT00665561|Primary|Percentage of Participants With All-Cause Mortality|All-cause death was defined as the death due to any cause during the course of study.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||Percentage of participants|||Number
2780666|NCT00665561|Primary|Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause|Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780667|NCT00665561|Primary|Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'|Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780693|NCT00665431|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|12 weeks|intent to treat with last observation carried forward|||Scores on a scale||Standard Deviation|Mean
2780694|NCT00665431|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks|Intent to treat|||Tablets per subject||Standard Deviation|Mean
2794922|NCT00556933|Secondary|Patient Survival||Two years||||participants|||Number
2780668|NCT00665561|Primary|Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'|Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780669|NCT00665561|Primary|Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)|Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780670|NCT00665561|Primary|Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections|Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780671|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause|Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780672|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause|Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780673|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis|Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780674|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'|Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780675|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'|Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780676|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Liver Failure|Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780677|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)|Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780678|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis|Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780679|NCT00665561|Primary|Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections|Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).|Up to 5 years following enrollment|Safety analysis set included all participants who were enrolled in the study.|||events per 1000 participant-years||95% Confidence Interval|Number
2780680|NCT00665470|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V3.0|Here is the number of participants with adverse events. For a detailed list of participants with adverse events, see the adverse event module.|16 months||||Participants|||Number
2780681|NCT00665470|Primary|Response|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|30 months||||Participants|||Number
2780682|NCT00665457|Primary|Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure|CTEP RECIST guidelines are defined as followed: Pathologic complete response is no signs of residual malignancy cells at the primary site and axillary lymph nodes are seen with histologic examination. Progression-free survival is defined as from the first date of therapy until the first notation of clinical progression or relapse. Overall survival is defined as from the first date of therapy until the date of death. Time to treatment failure is defined as from the first date of therapy until the date the patient is removed from study for any reason.|20 weeks||||Participants|||Count of Participants
2780683|NCT00665457|Primary|Number of Participants With Grade 4 Adverse Events|Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE.|every 3 weeks X 4, then every 2 weeks X4|Of the 3 participants, one had a grade 4 event - neutropenic fever.|||Participants|||Count of Participants
2780684|NCT00665444|Secondary|Hamilton Rating Scale for Depression||3 months|Study was terminated early and data were not collected for this outcome.||||||
2780685|NCT00665444|Secondary|Young Mania Rating Scale||3 months|Study was terminated early and data were not collected for this outcome.||||||
2780686|NCT00665444|Secondary|Quality of Life Enjoyment Questionnaire||3 months|Study was terminated early and data were not collected for this outcome.||||||
2780687|NCT00665444|Secondary|Global Assessment of Functioning||3 months|Study was terminated early and data were not collected for this outcome.||||||
2780688|NCT00665444|Primary|Epworth Sleepiness Scale (General Level of Daytime Sleepiness)||3 month|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.||||||
2780689|NCT00665444|Primary|BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),||3 months|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.||||||
2780690|NCT00665431|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
2780691|NCT00665431|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
2780692|NCT00665431|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat|||percent days||Standard Deviation|Mean
2780720|NCT00665353|Primary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.||Week 24 of Step 2|All enrolled subjects.|||proportion of participants||90% Confidence Interval|Number
2780695|NCT00665431|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat|||mm||Standard Deviation|Mean
2780696|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
2780697|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
2780698|NCT00665431|Secondary|Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|For APS-POQ score is the change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to treat|||Units on a scale||Standard Deviation|Mean
2780699|NCT00665431|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
2780700|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
2780701|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
2780702|NCT00665366|Secondary|Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)|BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.|||kg/m^2||Full Range|Median
2780703|NCT00665366|Secondary|Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)|Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.|||Percentage of participants|||Number
2780704|NCT00665366|Secondary|Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.|||Kilograms||Standard Error|Mean
2780705|NCT00665366|Secondary|Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)|Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
2780706|NCT00665366|Secondary|Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 6 and 12|All randomized participants who received at least 1 dose of study medication and had at least 1 outcome research evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
2780707|NCT00665366|Secondary|Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)|Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Weeks 3,6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Percentage of participants|||Number
2780708|NCT00665366|Secondary|Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)|Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Percentage of participants|||Number
2780709|NCT00665366|Secondary|Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)|The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
2780710|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)|Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
2780711|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
2780712|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.|||Units on a scale||Standard Error|Mean
2780713|NCT00665366|Primary|Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)|The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient's manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug.|||Units on a scale||Standard Error|Mean
2780714|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 fasting lipid results.|||mg/dL||Inter-Quartile Range|Median
2780721|NCT00665132|Secondary|Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5|Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ''no pain'' and a 10 for ''pain as bad as you can imagine.'' At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15).|Day 5 after final stimulation|Nine subjects who reported change after 5 days of StimRouter System use are analyzed to determine mean change in pain from Baseline to Day 5 of Stimulation for the overall group.|||units on a scale||Standard Deviation|Mean
2780722|NCT00665132|Secondary|Percent of Participants Reporting Pain Change From Baseline to Day 5|Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is used to rate pain intensity, where zero (0) indicates ''no pain'' and 10 indicates ''pain as bad as you can imagine.'' At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated.|Day 5|All ten participants were analyzed.|||percentage of patients|||Number
2780723|NCT00665132|Secondary|Patent Satisfaction|Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied|Day 5 after final stimulation|All ten subjects responses were analyzed.|||units on a scale||Standard Deviation|Mean
2780724|NCT00665132|Primary|Implant Success|Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.|at device implantation procedure||||participants with successful implant|||Number
2780725|NCT00665002|Secondary|Participants Whose Samples Demonstrated Immunological Response After Vaccination|"Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well.~ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release.~Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion.~Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders).~Overall: any form of immune response."|12 weeks|All participants|||participants|||Number
2780726|NCT00665002|Primary|Number of Participants With Adverse Events (AEs)|Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.|12 weeks to 6 months|All participants|||participants|||Number
2780727|NCT00664859|Secondary|Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment|Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)|52 weeks from DB baseline and 40 weeks from OL baseline||||Percent change||Standard Deviation|Mean
2780728|NCT00664859|Primary|Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment|Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)|52 weeks from DB baseline and 40 weeks from OL baseline|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
2780729|NCT00664755|Primary|End-of-treatment Abstinence|Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment|2 weeks||||Participants|||Count of Participants
2780730|NCT00664742|Secondary|Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels|The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.|Baseline, 6 weeks|This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.|||Percentage of Participants|||Number
2780731|NCT00664742|Primary|Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6|Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.|Baseline,6 weeks|The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.|||mg/dL||95% Confidence Interval|Mean
2780745|NCT00664534|Secondary|Rate Per 30 Days of All Self-reported Hypoglycemic Episodes|The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.|||episodes per 30 days||Standard Deviation|Mean
2780732|NCT00664560|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
2780733|NCT00664560|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population|||participants|||Number
2780734|NCT00664560|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat|||percent days||Standard Deviation|Mean
2780735|NCT00664560|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
2780736|NCT00664560|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks||||Tablets per subject||Standard Deviation|Mean
2780737|NCT00664560|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat|||mm||Standard Deviation|Mean
2780738|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
2780739|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat|||mm||Standard Deviation|Mean
2780740|NCT00664560|Secondary|American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to Treat|||Units on a scale||Standard Deviation|Mean
2780741|NCT00664560|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
2780742|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
2780743|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward|||mm||Standard Deviation|Mean
2780744|NCT00664534|Secondary|Number of Participants With Adverse Events|"A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.~TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline."|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period.|||participants|||Number
2781228|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Response Rate|Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information|||percentage of participants||95% Confidence Interval|Number
2780746|NCT00664534|Secondary|Incidence of All Self-reported Hypoglycemic Episodes|Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.|||percentage of participants|||Number
2780747|NCT00664534|Secondary|Body Weight Change From Baseline to Endpoint||baseline, 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
2780748|NCT00664534|Secondary|Mean Daily Total, Basal and Prandial Insulin Dose||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||International Units per day (IU/day)||Standard Deviation|Mean
2780749|NCT00664534|Secondary|Mean Postprandial Blood Glucose Values|Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||microgram per milliliter (µg/mL)||Standard Deviation|Mean
2780750|NCT00664534|Secondary|7-point Self-monitored Blood Glucose Profiles||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
2780751|NCT00664534|Secondary|Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||percentage of participants|||Number
2780752|NCT00664534|Secondary|HbA1c Over Time|Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population.|16 weeks, 32 weeks, and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.|||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2780753|NCT00664534|Secondary|Percentage of Participants Using Each Possible Final Insulin Regimen|"Insulin Regimens:~Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro."|48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles.|||percentage of participants|||Number
2780754|NCT00664534|Primary|Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint|Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.|48 weeks|"PP Population=All participants who were randomized and met following criteria during study:~no violations of Inclusion/Exclusion Criteria~no early study discontinuation~compliant with treatment~received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for >14 consecutive days."|||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2780755|NCT00664521|Secondary|Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells|Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels.|Baseline, Week 3, 7, 12, 16, 26 and 32|Safety population included all participants who received at least one dose of atacicept or placebo. Here 'n' signifies those participants who were evaluable for the specified category.|||percent change||Inter-Quartile Range|Median
2780756|NCT00664521|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Baseline, Week 32|ITT population included all randomized participants. Here 'n' signifies those participants who were evaluable for the specified category.|||Units on a scale||Standard Deviation|Mean
2780768|NCT00664326|Other Pre-specified|Time to Progression (Update)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
2780757|NCT00664521|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32|ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP.|Week 32|ITT population included all randomized participants.|||percentage of participants|||Number
2780758|NCT00664521|Primary|Percent Change From Baseline in Anti-pneumococcus Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||percent change||Inter-Quartile Range|Median
2780759|NCT00664521|Primary|Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here. N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||percent change||Inter-Quartile Range|Median
2780760|NCT00664521|Primary|Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32|Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category."|||Percent change||Standard Deviation|Mean
2780761|NCT00664521|Primary|Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)||Week 64|Safety population included all participants who received at least one dose of atacicept or placebo. Here. “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2780762|NCT00664521|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 64|Safety population included all participants who received at least one dose of atacicept or placebo.|||Participants|||Number
2780763|NCT00664430|Secondary|Number of Participants With Adverse Events|The occurrence of adverse events was considered a secondary endpoint in this study. For details on adverse events that occurred prior to study termination, refer to the safety section below.|Up to 1 year||||Participants|||Number
2780764|NCT00664430|Secondary|Changes in Bone Remodeling Markers Over Time|Deoxypyridinoline and bone-specific alkaline phosphatase levels were to be measured every 3 months and changes over time analyzed using descriptive statistics.|Every 3 months|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the secondary analysis.|||ng/mL||Standard Deviation|Mean
2780765|NCT00664430|Primary|Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values|This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.|Up to Week 24|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the primary analysis.|||Proportion of participants|||Number
2780766|NCT00664326|Other Pre-specified|Duration of Stable Disease (Update)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.|||Days||95% Confidence Interval|Median
2780767|NCT00664326|Other Pre-specified|Duration of Response (Update)|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.|||Days||95% Confidence Interval|Median
2794923|NCT00556933|Secondary|Graft Survival|Graft failure = permanent return of patient to dialysis.|Two years||||participants|||Number
2780769|NCT00664326|Other Pre-specified|Progression-free Survival (Update)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
2780770|NCT00664326|Other Pre-specified|Overall Survival (Update)|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
2780771|NCT00664326|Other Pre-specified|Disease Control (Update)|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
2780772|NCT00664326|Other Pre-specified|Tumor Response (Update)|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
2780773|NCT00664326|Other Pre-specified|Objective Tumor Response (Update)|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
2780774|NCT00664326|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.|||Days||95% Confidence Interval|Median
2780775|NCT00664326|Secondary|Duration of Response|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.|||Days||95% Confidence Interval|Median
2780776|NCT00664326|Secondary|Time to Progression (TTP)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
2780777|NCT00664326|Secondary|Progression-free Survival (PFS)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
2780778|NCT00664326|Secondary|Overall Survival|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).|intention-to-treat (ITT)|||Days||95% Confidence Interval|Median
2780779|NCT00664326|Secondary|Disease Control|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
2780780|NCT00664326|Primary|Tumor Response|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
2780781|NCT00664326|Primary|Objective Tumor Response|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)|||Percentage of participants|||Number
2780782|NCT00664209|Secondary|Participants With Side Effects From Study Treatment|Side effects profile|2 months|All subjects receiving H. pylori treatment|||participants|||Number
2780783|NCT00664209|Secondary|Improvement in Quality of Life as Assessed by PDQ-39|The Parkinson's Disease Questionnaire (PDQ)-39 contains 39 questions addressing how often patients have experienced difficulties due to having PD in the preceding month. Items are scored from 0 (never) to 4 (always). Lower scores indicate better quality of life.|2 months|Subjects H pylori positive with greater than 4 hrs off time/day and completing the PDQ-29||||||
2780784|NCT00664209|Secondary|Improvement in UDPRS Part III|"Improvement in UDPRS Part III (Motor) scores (on and off) UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement"|2 months|Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS||||||
2780785|NCT00664209|Secondary|Improvement in UPDRS Total Scores|The Unified Parkinson Disease Rating Scale (UPDRS) is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.|2 months|Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS||||||
2780786|NCT00664209|Primary|"Off Time"|"Average total daily off time (measured by patient symptom diaries) in hours"|2 months|Participants did not return symptom diaries||||||
2780787|NCT00664105|Secondary|Number of Participants With Adverse Events by Grade|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event|30 days after last treatment.|Patients who received treatment and who experienced an adverse event.|||participants|||Number
2780788|NCT00664105|Secondary|Time to Disease Progression|Time to disease progression in months|on-study date to date of progression|Patients with disease progression.|||Months||Full Range|Median
2780789|NCT00664105|Secondary|Overall Response Rate|"Patient response to treatment per RECIST:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|on-study date to date of best response|Patients who were available for measurement of response. Six patients were not available for measurement of response and are not included in the analyzed population|||participants|||Number
2780790|NCT00664105|Primary|Overall Survival|Months from on-study to expired/last date known alive.|14.95 months (average duration, on study date to off-study date)|Patients who received at least one treatment and who were available for determination of overall survival.|||Months||Full Range|Median
2780791|NCT00664066|Primary|Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|up to 3 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||Participants|||Number
2780792|NCT00663962|Primary|Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively|Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)|2 months postoperatively|pilot study--convenience|||participants|||Number
2780793|NCT00663962|Primary|The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.||2, 4, and 6 months|||||||
2780794|NCT00663923|Secondary|Surgically Induced Astigmatism|"It is the vector of the astigmatic change actually induced by the surgery.Participant population was the same as baseline participants.~It was measured by refraction(using autorefractor) and vector analysis(using special software).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters"|six months after surgery||||Diopter||Standard Deviation|Mean
2780795|NCT00663923|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|UCDVA is attained without correction of refractive errors .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart( the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol|||LogMAR|Participants|Standard Deviation|Mean
2781311|NCT00661037|Secondary|Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up||2 years||||Participants|||Count of Participants
2780796|NCT00663923|Secondary|Corrected Distance Visual Acuity(CDVA)|CDVA is attained after correction of refractive errors using lenses of varying powers .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart(the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol|||LogMAR|Participants|Standard Deviation|Mean
2780797|NCT00663923|Secondary|Higher Order Aberrations|Although lower- order aberrations decrease after laser vision correction,higher -order aberrations may increase after conventional PRK or LASIK(Laser in situ keratomileusis).Higher-order aberration is Composed of delicate irregularities within the cornea not correctable by spectacles.It is measured using aberrometer.In this study OPD scan was used that is one of the methods of wavefront analysis .|six months postoperative|the analysis was per protocol.|||micron|Participants|Standard Deviation|Mean
2780798|NCT00663923|Primary|Correction of Astigmatism|It shows the result of correction of astigmatism .In compound myopic astigmatism the meridians of maximum and minimum power are both too strong.So both line images fall short of the retina.It is measured by refraction(using autorefractor).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters.|six months after surgery|"The sample size was determined by the one proportion formula where power = 0.8, d=0.02 , p= 0.5(primary outcome) and type I error probability associated with this test of null hypothesis is 0.05.~The analysis was per protocol"|||diopter|Participants|Standard Deviation|Mean
2780799|NCT00663858|Primary|International Prostate Symptom Score (IPSS)|IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks||||Units on a scale||Standard Deviation|Mean
2780800|NCT00663819|Secondary|Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.|Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.|Within 4 - 12 weeks post-surgery|"Significant Post Operative Complications"|||Participants|||Count of Participants
2780801|NCT00663819|Secondary|Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses||Post operative||||Participants|||Count of Participants
2780802|NCT00663819|Secondary|Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.||Post operative||||Participants|||Count of Participants
2780803|NCT00663819|Primary|Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak|The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.|Completion of procedure through 4-12 weeks post procedure||||Participants|||Count of Participants
2780804|NCT00663793|Secondary|Area Under the Curve-E2||14 Days||||nmol*h/L||Standard Deviation|Mean
2780805|NCT00663793|Secondary|Area Under the Curve-serum DHT||14-days||||nmol*h/L||Standard Error|Mean
2780806|NCT00663793|Primary|Area Under the Curve-Serum T||14 days||||nmol*h/L||Standard Error|Mean
2780807|NCT00663702|Primary|Mean Temperature|Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable|||Degrees Celsius||Standard Deviation|Mean
2780808|NCT00663702|Primary|Mean Heart Rate|Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable|||Beats per minute||Standard Deviation|Mean
2780809|NCT00663702|Primary|Mean Sitting Systolic and Diastolic Blood Pressure (BP)|BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable|||mm Hg||Standard Deviation|Mean
2780810|NCT00663702|Primary|Number of Participants With Adverse Events of Special Interest|AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication.|||Participants|||Number
2780811|NCT00663702|Primary|Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality|preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
2781039|NCT00662363|Primary|Change in Patient Assessment of Constipation - Quality of Life|The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged.|Baseline and day 7|intention to treat|||units on a scale||Standard Deviation|Mean
2780812|NCT00663702|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time|The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.|Day 1 (Baseline) to Day 1093|All participants who received at least 1 dose of study medication|||Units on a scale||Standard Deviation|Mean
2780813|NCT00663702|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:|LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2780814|NCT00663702|Secondary|Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time|The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication|||Units on a scale||Standard Deviation|Mean
2780815|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85|"Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:~A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline~A negative baseline immunogenicity response and a positive immunogenicity response postbaseline~A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value"|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable|||Percentage of participants|||Number
2780816|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85|Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable|||Percentage of participants|||Number
2780817|NCT00663702|Primary|Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
2780818|NCT00663702|Primary|Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
2780819|NCT00663702|Primary|Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
2780820|NCT00663702|Primary|Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable|||Participants|||Number
2781107|NCT00661999|Primary|Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response|Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 Weeks||||Participants|||Number
2780821|NCT00663702|Primary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication|||Participants|||Number
2780822|NCT00663702|Secondary|Mean Trough Serum Concentration (Cmin) of Abatacept|Cmin of abatacept was determined from serum samples.|Days 29, 85, 57, and 85|All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2780823|NCT00663702|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.|Day 1 (Baseline) through Day 85|All participants who received at least 1 dose of study medication|||Participants|||Number
2780824|NCT00663403|Secondary|Daptomycin Free Fraction|"In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the free component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria."|From time of daptomycin administration to 48 hours post dose||||percent protein binding||Standard Deviation|Mean
2780825|NCT00663403|Secondary|Daptomycin Half-life|Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis||||hours||Standard Deviation|Mean
2780826|NCT00663403|Secondary|Daptomycin Total Body Clearance|Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis||||mL/min/kg||Standard Deviation|Mean
2780827|NCT00663403|Secondary|Daptomycin Volume of Distribution at Steady State|Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.|From time of daptomycin administration to 48 hours post dose||||L/kg||Standard Deviation|Mean
2780828|NCT00663403|Secondary|Observed Daptomycin Peak Serum Concentration|The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.|At the end of the daptomycin intravenous infusion (at approximately 30 minutes)||||ug/mL||Standard Deviation|Mean
2780829|NCT00663403|Secondary|Daptomycin Dose Actually Administered||Time of daptomycin administration||||mg/kg||Standard Deviation|Mean
2780830|NCT00663403|Primary|Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis|Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis||||mL/min||Standard Deviation|Mean
2780831|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
2780832|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2780833|NCT00663260|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
2784957|NCT00630539|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear||12 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
2780834|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
2780835|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
2780836|NCT00663234|Secondary|Percentage of Participants With Undetectable Plasma HIV-1 RNA|Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.|Study entry and weeks 12, 24, and 48|All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.|||percentage of participants||90% Confidence Interval|Number
2780837|NCT00663234|Secondary|Percent Change in Interleukin 6 (IL-6) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.|||percentage of IL-6 at study entry||90% Confidence Interval|Median
2780838|NCT00663234|Secondary|Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.|||percentage of hs-CRP at study entry||90% Confidence Interval|Median
2780839|NCT00663234|Secondary|Percent Change in Apolipoprotein B (Apo B) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.|||percentage of Apo B at study entry||90% Confidence Interval|Mean
2780840|NCT00663234|Secondary|Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.|||percentage of Apo A-1 at study entry||90% Confidence Interval|Mean
2780841|NCT00663234|Secondary|Percent Change in HDL-cholesterol (HDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.|||percentage of HDL-C at study entry||90% Confidence Interval|Mean
2780842|NCT00663234|Secondary|Percent Change in Triglycerides (TG) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.|||percentage of TG at study entry||90% Confidence Interval|Mean
2780843|NCT00663234|Secondary|Percent Change in Fasting Total Cholesterol (TC) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.|||percentage of TC at study entry||90% Confidence Interval|Mean
2780844|NCT00663234|Primary|Percent Change in LDL Cholesterol (LDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.|||percentage of LDL-C at study entry||90% Confidence Interval|Mean
2780845|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.|||percentage of participants||90% Confidence Interval|Number
2780846|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.|||percentage of participants||90% Confidence Interval|Number
2780847|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
2780848|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits).|||percentage of participants||90% Confidence Interval|Number
2780849|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.|||percentage of participants||90% Confidence Interval|Number
2780850|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.|||percentage of participants||90% Confidence Interval|Number
2780851|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
2780852|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.|||percentage of participants||90% Confidence Interval|Number
2780853|NCT00663208|Secondary|Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters|Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec.|Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28|All participants treated with study drug were summarized.|||participants|||Number
2780854|NCT00663208|Secondary|Number of Participants With Clinically Relevant Change From Baseline in Vital Signs|Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1.|Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28|All participants treated with study drug were summarized.|||participants|||Number
2780855|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Urinalysis|Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.|||participants|||Number
2780856|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose|Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.|||participants|||Number
2780857|NCT00663208|Secondary|Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes|Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants who were treated with study drug were summarized.|||participants|||Number
2780858|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematology|Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.|||participants|||Number
2780859|NCT00663208|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 182 or Day of Discharge|All participants who received study drug were summarized.|||participants|||Number
2780860|NCT00663208|Secondary|Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance|Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU).|Day 4, Day 14|All participants who received at least 1 dose of daclatasvir and who had no baseline genotype resistance were analyzed. Placebo participants were excluded from this analysis.|||Correlation Coefficient|||Number
2780861|NCT00663208|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14|Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||h||Full Range|Median
2780862|NCT00663208|Secondary|Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14|Accumulation index area under the concentration-time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS).|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2780863|NCT00663208|Secondary|Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14|The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2780864|NCT00663208|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14|The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2780865|NCT00663208|Secondary|Plasma Half-life (T-half) of Daclatasvir at Day 14|The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||h||Standard Deviation|Mean
2780866|NCT00663208|Secondary|Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14|The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2780867|NCT00663208|Secondary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14|The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available Pharmacokinetic (PK) data were summarized.|||nanograms/milliliters(ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2780868|NCT00663208|Secondary|Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||log10 IU/mL||Standard Deviation|Mean
2780869|NCT00663208|Secondary|Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||Days||Standard Deviation|Mean
2780870|NCT00663208|Secondary|Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||log10 IU/mL||90% Confidence Interval|Mean
2780871|NCT00663208|Secondary|Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 4|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.|||log10 IU/mL||90% Confidence Interval|Mean
2781064|NCT00662155|Primary|Overall Average Sleep Continuity Profile|The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep continuity as a function of treatment.|12-week average during Phase 3|These were participants that meant compliance criteria and were included in all analyses.|||minutes||Standard Error|Mean
2780872|NCT00663208|Secondary|Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations were summarized.|||log10 IU/mL||Standard Deviation|Mean
2780873|NCT00663208|Primary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.|||log10 IU/mL||90% Confidence Interval|Mean
2780874|NCT00663208|Secondary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.|||log10 IU/mL||90% Confidence Interval|Mean
2780875|NCT00663169|Secondary|Number of Patients Who Took Rescue Medication|Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.|4 months|All participants.|||Participants|||Number
2780876|NCT00663169|Secondary|Change From Baseline in Pain Using a Visual Analog Scale at Month 4|Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.|||Score on a scale||Standard Deviation|Mean
2780877|NCT00663169|Secondary|ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period|Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).|Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.|||μg/mL||Standard Deviation|Mean
2780878|NCT00663169|Secondary|Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.|||mg/L||Standard Deviation|Mean
2780879|NCT00663169|Secondary|Change in C-reactive Protein (CRP) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.|||mg/L||Standard Deviation|Mean
2780880|NCT00663169|Secondary|Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study|Additional safety information can be found in the Adverse Event section.|4 months||||Participants|||Number
2780881|NCT00663169|Secondary|Time to Walk Independently (if Applicable) During Treatment Period||4 months|Since the study recruited only 6 subjects this analysis was not done.||||||
2780882|NCT00663169|Secondary|Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period|Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.|4 months|Since the study recruited only 6 subjects this analysis was not done.||||||
2780883|NCT00663169|Secondary|Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period||72 hours|Since the study only recruited 6 subjects this analysis was not done.||||||
2780884|NCT00663169|Primary|Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale|"72 hours following treatment, patients were asked the question: How would you rate the improvement in your gout since receiving the study medication? Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a good or excellent response."|72 hours|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.|||Percentage of participants|||Number
2780885|NCT00663117|Secondary|Histology Inflammatory Score by Colon Biopsies|Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..|12 weeks|Tissue was removed by biopsy in those undergoing colonoscopy|||units on a scale||Standard Error|Mean
2780886|NCT00663117|Secondary|Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy|A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn's Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983-989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of > 5 points from baseline. Endoscopic remission is a score of < 6 and Complete endoscopic remission is a score of > 3.|12 weeks|Sample size was calculated under the assumption that at least 60% of the naltrexone-treated patients, and no more than 10% of the placebo-treated patients, would respond with at least a 70-point decline in CDAI scores. With a 10% withdrawal rate, 40 subjects yields an 86% power using a two-sided, 0.05-significance level Fisher’s exact test.|||percentage of patients|||Number
2780887|NCT00663117|Secondary|Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)|IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.|Between baseline and 3 months|Same as sample size calculation|||percentage of change||Standard Error|Mean
2780888|NCT00663117|Primary|Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;|The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.|3 months||||percentage of pts|||Number
2780889|NCT00663052|Other Pre-specified|Mean Number of Doctor Visits|As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Visits||Standard Deviation|Mean
2780890|NCT00663052|Other Pre-specified|Percentage of Participants With Doctor Visits|As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Percentage of participants|||Number
2780891|NCT00663052|Other Pre-specified|Mean Number of Emergency Room Days|As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Days||Standard Deviation|Mean
2780892|NCT00663052|Other Pre-specified|Percentage of Participants With Emergency Room Visits|As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Percentage of participants|||Number
2780893|NCT00663052|Other Pre-specified|Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores|FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
2780894|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24|MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
2780895|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12|MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
2780896|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 24|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.|||Percentage of indicated parameter||Standard Deviation|Mean
2780897|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 12|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.|||Percentage of indicated parameter||Standard Deviation|Mean
2781103|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 16|Value at 16 weeks minus value at baseline.|Baseline and 16 weeks||||g/dL||Standard Deviation|Mean
2780898|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780899|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780900|NCT00663052|Other Pre-specified|Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780901|NCT00663052|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780902|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
2780903|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780904|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24|PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
2780905|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12|PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Deviation|Mean
2780934|NCT00663039|Secondary|Hopkins Verbal Learning Test (HVLT)|HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first study day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials.|15 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
2780906|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780907|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780908|NCT00663052|Other Pre-specified|Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12|PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.|Baseline, Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780909|NCT00663052|Secondary|Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24|Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.|From Week 12 to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
2780910|NCT00663052|Secondary|Change From Baseline in the Photographed Image of Lesions in Selected Participants|Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.|Baseline to Week 24|The data was not collected as planned.|||Units on scale|||Number
2780911|NCT00663052|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24||Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of BSA||Standard Deviation|Mean
2780912|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780913|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24|SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780914|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780915|NCT00663052|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2781104|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 7|Value at 7 weeks minus value at baseline.|Baseline and 7 weeks||||g/dL||Standard Deviation|Mean
2780916|NCT00663052|Secondary|Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks|Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.|||Days||95% Confidence Interval|Median
2780917|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780918|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780919|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780920|NCT00663052|Secondary|Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks|Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. Observed cases (OC) analyses were performed including only those participants who were evaluated at the specified visits.|||Days||95% Confidence Interval|Median
2780921|NCT00663052|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Units on scale||Standard Error|Mean
2780922|NCT00663052|Secondary|Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants||95% Confidence Interval|Number
2780923|NCT00663052|Secondary|Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
2781021|NCT00662558|Secondary|Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores|The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.|Baseline, Week 6/ET|ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.|||participants|||Number
2780924|NCT00663052|Secondary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
2780925|NCT00663052|Secondary|Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.|||Percentage of participants|||Number
2780926|NCT00663052|Primary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent-to-treat (mITT) population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||Percentage of participants|||Number
2780927|NCT00663039|Secondary|Facial Affect Recognition|This computer administered test includes 40 color photographs of four universal emotions (happy, sad, angry, and fearful) balanced for the posers gender, age, and ethnicity, including four low intensity and four high-intensity facial expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity.|10 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of responses||Standard Deviation|Mean
2780928|NCT00663039|Secondary|Reading the Mind in the Eyes|A 30 item task presents a picture of a person's eyes and the participant is ask to determine the person's mental state from 4 multiple choice options.|10 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
2780929|NCT00663039|Secondary|Brief Smell Identification Test|The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor.|5 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
2780930|NCT00663039|Secondary|Brief Assessments of Cognition for Schizophrenia|The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer and provides a highly reliable measure of processing speed. There are nine symbols code 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches is the participants score. Scores range from 0-110.|5 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of correct responses||Standard Deviation|Mean
2780931|NCT00663039|Secondary|Rapid Visual Information Processing Test (RVIP)|RVIP measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600ms; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits. There are a total of 48 target sequences during each test block. The number of correctly Identified target sequences or hits is recorded, as well as, false alarms (incorrectly identified target sequences) and reaction times.|25 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Number of responses||Standard Deviation|Mean
2780932|NCT00663039|Secondary|RVIP Reaction Times|Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when they see a target sequence of 3 odds or 3 even digits in a consecutive sequence. Two target sequences are separated by a minimum of 5 and maximum of 30 non-target digits|25 minutes|Analyzable data for secondary outcomes was not available for some participants.|||milliseconds||Standard Deviation|Mean
2780933|NCT00663039|Secondary|Trust Game|Participants competed in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds the participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive an portion of the total offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240.|20 minutes|Analyzable data for secondary outcomes was not available for some participants.|||Dollars||Standard Deviation|Mean
2780935|NCT00663039|Primary|Social Affiliation Measured by Social Affiliative Role Play|In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).|30 minutes|Of the 27 ppts that were screened and deemed eligible for study participation, only 19 completed testing while receiving oxytocin and only 18 complete testing while receiving placebo.|||units on a scale||Standard Deviation|Mean
2780936|NCT00663026|Secondary|Apparent Systemic Clearance (CL/F)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milliliter/hour/kilogram (mL/hr/kg)||Standard Deviation|Mean
2780937|NCT00663026|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
2780938|NCT00663026|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F).|||hours||Full Range|Median
2780939|NCT00663026|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|t1/2 not calculated due to inadequate characterization of the terminal elimination phase.||||||
2780940|NCT00663026|Secondary|Average Serum Concentration at Steady State (Cavg,ss)|Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2780941|NCT00663026|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]).|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2780942|NCT00663026|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after Week 25 dose|Safety population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2780943|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2780944|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2780945|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2780946|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2780947|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
2780948|NCT00662909|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Percentage of participants|||Number
2780949|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
2780950|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2780951|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2780959|NCT00662909|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Percentage of participants|||Number
2780952|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Scores on a scale||Standard Deviation|Mean
2780953|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percent activity impairment||Standard Deviation|Mean
2780954|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent overall work impairment||Standard Deviation|Mean
2780955|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent impairment while working||Standard Deviation|Mean
2780956|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent work time missed||Standard Deviation|Mean
2780957|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.|||Scores on a scale||Standard Error|Least Squares Mean
2780958|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.|||Scores on a scale||Standard Error|Least Squares Mean
2780989|NCT00662831|Secondary|Number of Participants Who Died||Week 24 (EOT) or early termination|ITT population included all participants who were randomized.|||participants|||Number
2780960|NCT00662909|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Percentage of participants|||Number
2780961|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||pads||Standard Error|Least Squares Mean
2780962|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis.~N is the number of participants included at each time point."|||Nocturia episodes||Standard Error|Least Squares Mean
2780963|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.|||Scores on a scale||Standard Error|Least Squares Mean
2780964|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||Urgency episodes||Standard Error|Least Squares Mean
2780965|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.|||Urgency incontinence episodes||Standard Error|Least Squares Mean
2780966|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.|||mL||Standard Error|Least Squares Mean
2780967|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not used in this analysis. The number of patients included in the calculation for each time point is noted as “N”.|||Micturitions||Standard Error|Least Squares Mean
2780968|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
2780969|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not used in this analysis.|||Micturitions||Standard Error|Least Squares Mean
2780970|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not used in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
2780971|NCT00662909|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.|||mL||Standard Error|Least Squares Mean
2780972|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.|||Micturitions||Standard Error|Least Squares Mean
2780973|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (Final Visit)|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was used in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
2780974|NCT00662857|Primary|Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro|Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)|0 to 360 minutes post-dose|"Rapid-acting insulin Analogue (RAA) Population~All subjects who had serum insulin concentration data for both TI Inhalation Powder B and insulin lispro and were deemed to be protocol compliant (no major protocol violations during the clinical trial)."|||(micro U)*min/mL||Standard Error|Least Squares Mean
2780975|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax||0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).|||min||Full Range|Median
2780976|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.|Maximum observed baseline-corrected serum insulin concentration|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).|||(micro U)/mL||Standard Error|Least Squares Mean
2780977|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360|Dose-normalized baseline-corrected area under the serum insulin vs. time curve|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).|||(micro U)*min/mL||Standard Error|Least Squares Mean
2780978|NCT00662831|Other Pre-specified|Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||hemorrhages|||Number
2780979|NCT00662831|Other Pre-specified|Number of Major and Minor Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||hemorrhages|||Number
2780980|NCT00662831|Other Pre-specified|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||hemorrhages|||Number
2780981|NCT00662831|Secondary|Transcutaneous Local Tissue Oxygenation (pO2)|Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were analyzed at selected sites only, based on availability. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2780982|NCT00662831|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2780983|NCT00662831|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2780984|NCT00662831|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||mm||Standard Deviation|Mean
2780985|NCT00662831|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2780986|NCT00662831|Secondary|Median Time to First Amputation||Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||||||
2780987|NCT00662831|Secondary|Time to Intact Skin Healing|Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||||||
2780988|NCT00662831|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||||||
2780990|NCT00662831|Secondary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||participants|||Number
2780991|NCT00662831|Secondary|Number of Participants Who Underwent Major and Minor Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.|||participants|||Number
2780992|NCT00662831|Secondary|Number of Participants Who Underwent Any Amputation|Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.|||participants|||Number
2780993|NCT00662831|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||participants|||Number
2780994|NCT00662831|Primary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 [end of treatment (EOT)] or early termination|Intention to treat (ITT) population included all participants who were randomized. Last observation carried forward (LOCF) method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||participants|||Number
2780995|NCT00662818|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose|SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|Up to 24 hours post-dose (Up to 14 weeks)|The FAS population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.|||Percentage of Participants||95% Confidence Interval|Number
2780996|NCT00662818|Secondary|Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for nausea prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.|||Percentage of Participants||95% Confidence Interval|Number
2780997|NCT00662818|Secondary|Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 Hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for photophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.|||Percentage of Participants||95% Confidence Interval|Number
2780998|NCT00662818|Secondary|Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for phonophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.|||Percentage of participants||95% Confidence Interval|Number
2780999|NCT00662818|Secondary|Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose|Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.|Up to 48 hours after the dose of any study medication (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.|||Participants|||Number
2781037|NCT00662532|Primary|Overall PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 180||||mm||Standard Deviation|Mean
2781000|NCT00662818|Primary|Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 48 hours post-dose (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.|||Participants|||Number
2781001|NCT00662818|Primary|Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Within 14 days of any dose of study medication (Up to 16 weeks)|All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.|||Participants|||Number
2781002|NCT00662818|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of Participants||95% Confidence Interval|Number
2781003|NCT00662818|Primary|Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The full-analysis set (FAS) included participants treated for a migraine attack. Participants had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants||95% Confidence Interval|Number
2781004|NCT00662675|Secondary|Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase|Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase.|Entire 7 days double-blind phase|ITT|||Percent of participants|||Number
2781005|NCT00662675|Secondary|Change in Percent COA-Protein (Nitrogen)|The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|ITT|||percentage COA-protein||Standard Deviation|Mean
2781006|NCT00662675|Primary|Change in the Coefficient of Fat Absorption (COA-fat Percent)|Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase.|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|Intent-to-Treat (ITT)|||percentage COA-fat||Standard Deviation|Mean
2781007|NCT00662649|Secondary|Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression|Kurtzke's Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.|Core baseline to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.|||Percentage of patients||95% Confidence Interval|Number
2781008|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0 to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. This analysis included only patients with value at both core baseline and end of study.|||Percent change||Standard Deviation|Mean
2781009|NCT00662649|Primary|Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.|||Ratio of relapses per year||95% Confidence Interval|Number
2781038|NCT00662389|Primary|Serious Adverse Events|Number of Serious Adverse Events|Immediate||||Number of Serious Adverse Events|||Number
2781105|NCT00661999|Secondary|Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions||Week 1 to Week 16||||Participants|||Number
2781010|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.|||Relapses per year||95% Confidence Interval|Number
2781011|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.|||Percent change||Standard Deviation|Mean
2781012|NCT00662649|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.|||Percentage of patients|||Number
2781013|NCT00662649|Primary|Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free|A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.|Core baseline to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.|||Percentage of patients||95% Confidence Interval|Number
2781014|NCT00662649|Secondary|Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.|||Lesions||Standard Deviation|Mean
2781015|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0 to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.|||Relapses per year||95% Confidence Interval|Number
2781016|NCT00662558|Secondary|Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ|Subjects were successful responders if they had: > = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); > = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and < 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability).|Week 6/ET|ITT|||participants|||Number
2781017|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with walking and bending ability scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.|||participants|||Number
2781018|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Pain Relief Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with pain relief scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.|||participants|||Number
2781019|NCT00662558|Secondary|Patient's Global Evaluation of Study Medication|Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.|Weeks 1, 3, and 6/ET|ITT.|||participants|||Number
2781020|NCT00662558|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ)|The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.|Baseline, Week 6/ET|ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.|||scores on a scale||Standard Error|Mean
2781022|NCT00662558|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale|MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.|||scores on a scale||Standard Error|Mean
2781023|NCT00662558|Secondary|Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)|m-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367.|||scores on a scale||Standard Error|Mean
2781024|NCT00662558|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389.|||scores on a scale||Standard Error|Mean
2781025|NCT00662558|Secondary|Physician's Global Assessment of Disease Activity|"Number of subjects with a physician's grading of disease activity using the Physician's Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361.|||participants|||Number
2781026|NCT00662558|Secondary|Patient's Global Assessment of Disease Activity|"Number of subjects with a graded level of disease activity using the Patient's Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367.|||participants|||Number
2781027|NCT00662558|Secondary|Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)|"VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, During the past day, how much back pain did you have?, the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline."|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.|||mm||Standard Error|Mean
2781028|NCT00662558|Secondary|Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.|||scores on a scale||Standard Error|Mean
2781029|NCT00662558|Primary|Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)|A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).|Week 6 or Early Termination (ET)|Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF).|||participants|||Number
2781030|NCT00662545|Secondary|HIV RNA < 75 Copies/ml||entry, week 12, and week 24||||participants|||Number
2781031|NCT00662545|Secondary|Incidence of ALT Flares|ALT flare: sudden increase in blood level of alanine transaminase (ALT)|every 4 weeks for 24 weeks||||participants|||Number
2781032|NCT00662545|Secondary|Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)||every 4 weeks for 24 weeks||||participants|||Number
2781033|NCT00662545|Secondary|Incidence of Permanent Discontinuation Due to Toxicity||24 weeks||||participants|||Number
2781034|NCT00662545|Primary|Hepatitis B Virus (HBV) DNA|"HBV DNA carries the genetic blueprint of the virus. How many HBV DNA particles or copies are found in the blood indicates how rapidly the virus is reproducing in the liver."|week 24||||log 10 IU/ml||Full Range|Median
2781035|NCT00662532|Secondary|BOP Percent Reduction From Baseline|Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline|at Day 90 and Day 180|ITT|||Percentage of Participants||Standard Deviation|Least Squares Mean
2781036|NCT00662532|Secondary|Initial PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 90||||mm||Standard Deviation|Mean
2781040|NCT00662363|Primary|Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)|Patient Assessment of Constipation (PAC) - Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).|Baseline and Day 7, after treatment completed (6 days of treatment)|All subjects randomized and who had baseline and endpoint data were included in the intention to treat analysis.|||units on a scale||Standard Deviation|Mean
2781041|NCT00662311|Secondary|Safety and Toxicity of Vorinostat at the MTD as Assessed by NCI CTCAE Version 3.0|Count of participants with a grade 3 or higher toxicity. Toxicities were assessed using the NCI CTCAE (v3.0). Grade 3 or higher toxicities were considered worse.|Weekly during treatment, 30 days post-treatment, and 12 weeks post-treatment||||Participants|||Count of Participants
2781042|NCT00662311|Secondary|Overall Survival|Kaplan-Meier estimate|1 year||||survival probability||95% Confidence Interval|Number
2781043|NCT00662311|Secondary|Progression-free Survival|Kaplan-Meier estimate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|1 year||||progression free survival probability||95% Confidence Interval|Number
2781044|NCT00662311|Secondary|Duration of Response||Up to 3 years||||months||Full Range|Median
2781045|NCT00662311|Secondary|Radiological Response Rate as Assessed by CT|Count of participants with stable disease or partial response. Patients were evaluated for treatment response per RECIST criteria (version 1.0).|12 weeks post-treatment, then every 3 months for 2 years, and then every 6 months for a year thereafter||||Participants|||Count of Participants
2781046|NCT00662311|Primary|MTD of Vorinostat When Administered in Combination With Paclitaxel and Radiotherapy Therapy as Assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Defined as the highest dose level at which no more than 1 of 6 patients experiences dose-limiting toxicity (DLT). Toxicity was graded according to the National Institutes of Health Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A DLT was defined as any Grade 3 or higher non-hematologic adverse event with the exception of alopecia, fatigue, or anorexia. Nausea and/or vomiting that persisted > 48 hours despite optimal medical management at grade 3 or higher was considered a DLT. Hematologic dose-limiting toxicity was defined as either: Grade 4 neutropenia lasting for ≥ 7 days in duration, Grade > 3 febrile neutropenia with/without infection, Grade 4 thrombocytopenia or Grade 5 hematologic toxicity.|8 weeks||||mg|||Number
2781047|NCT00662298|Secondary|Changes in Asthma Control Symptoms Before and After Treatment||14 days|Data were not collected.||||||
2781048|NCT00662298|Secondary|Difference in Inflammatory Markers Between Day 1 and Day 14||14 days|Data were not collected||||||
2781049|NCT00662298|Secondary|Difference in FEV1 Between Day 1 and Day 14||14 days|Data were not collected||||||
2781050|NCT00662298|Secondary|Difference Between Baseline and Day 14 in Serum Prednisolone Levels||Baseline, 14 days||||nmol/litres||Full Range|Mean
2781051|NCT00662298|Primary|Changes in eNO, Sputum Eosinophils and Inflammatory Mediators Over 24 Hours||14 days|Data not collected||||||
2781052|NCT00662298|Primary|Change in FEV1 24 Hours Post Prednisolone||14 days|No data collected||||||
2781053|NCT00662298|Primary|Serum Prednisolone Levels Over 24 Hours||2h, 6h, 24h||||nmol/l||Standard Deviation|Mean
2781054|NCT00662259|Other Pre-specified|Score on Quick Inventory of Depressive Symptomatology|Measured the level of a participant's depression; 0 - 48; higher scores worse|0, 7, 28 days|Nineteen of 21 participants analyzed due to 2 participants withdrawal due to adverse events.|||score on a scale||Standard Deviation|Mean
2781055|NCT00662259|Secondary|Score on the Penn State Worry Scale|Measured participant's extent of worry; range 16 - 80, higher scores worse|0, 7, 28 days||||score on a scale||Standard Deviation|Mean
2781056|NCT00662259|Secondary|Score on the Hamilton Anxiety Scale|Measured participant's general anxiety; range 0 - 56; higher scores worse|0, 7, 28 days|Nineteen of 21 participants analyzed due to two participants withdrawing due to adverse events.|||score on a scale||Standard Deviation|Mean
2781057|NCT00662259|Primary|Signal Change in Brain Activity in the Insula When Anticipating the Viewing of Emotional Pictures.|Extent of activation of a brain signal when anticipating the viewing of an emotional picture as a percentage of brain signal when the viewing of an emotional signal is not anticipated. The brain signal is the blood oxygen level dependent signal as measured by functional magnetic resonance imaging.|0,1,28 days|Nineteen of 21 alprazolam participants analyzed to two subjects withdrawing due to adverse events.|||Percent signal change in brain acitivity||Standard Deviation|Mean
2781058|NCT00662259|Primary|Signal Change in Brain Activity in the Amygdala When Viewing Emotional Faces|Extent of activation a brain signal when matching emotional face expressions as a percentage of the brain signal when matching geometric designs. The brain signal is the blood oxygen level dependent signal measured by functional magnetic resonance imaging.|0,1,28 days|19 out of 21 participants analyzed due to 2 withdrawing from adverse events.|||Percent signal change in brain acitivity||Standard Deviation|Mean
2781059|NCT00662207|Primary|Number of Participants With a Urethral Sphincter Contractions||3 hour recording session||||participants|||Number
2781060|NCT00662207|Primary|Number of Participants With a Change in Anal Sphincter Pressure|Measured via balloon catheter|3 hour recording session||||participants|||Number
2781061|NCT00662207|Primary|Number of Participants With a Change in External Urethral Pressure|Measured via balloon catheter|3 hour recording session||||participants|||Number
2781062|NCT00662207|Primary|Number of Participants With a Change in Bladder Pressure|Measured via pressure catheter in bladder with a pressure transducer|3 hour recording session||||participants|||Number
2781063|NCT00662155|Primary|Overall Average Sleep Efficiency (%)|The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep efficiency (total sleep time/time in bed x 100) as a function of treatment.|12-week average during Phase 3|These were participants that meant compliance criteria and were included in all analyses.|||percent sleep efficiency||Standard Error|Mean
2781065|NCT00662129|Secondary|Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8|"Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0.~(*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986."|From baseline to end of Cycle 8; Up to 24 weeks|Of the participants evaluable for primary analysis, the Overall Number of Participants Analyzed reflects the number of subjects evaluable for this secondary outcome (with a FACT-B Trial Outcome Index score at baseline and at Cycle 8).|||units on a scale||95% Confidence Interval|Mean
2781066|NCT00662129|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||months||95% Confidence Interval|Median
2781067|NCT00662129|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years||||months||95% Confidence Interval|Median
2781068|NCT00662129|Secondary|Confirmed Response (Complete or Partial Response) Rate|A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100. The appropriate confidence interval will be calculated based on the binomial distribution.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||percentage of patients with CR or PR||95% Confidence Interval|Number
2781069|NCT00662129|Secondary|PFS Time|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||months||95% Confidence Interval|Median
2781070|NCT00662129|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||months||95% Confidence Interval|Median
2781071|NCT00662129|Primary|6-month Progression-free Survival (PFS) Rate|The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.|at 6 months|The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.|||proportion of patients progression-free||95% Confidence Interval|Number
2781072|NCT00662038|Primary|Percentage of Participants With Adverse Events|An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.|7.5 years|All participants who received any pirfenidone.|||percentage of participants|||Number
2781073|NCT00662025|Secondary|t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).~n=Number of participants with analyzable data."|||hours||Standard Deviation|Mean
2797691|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|Baseline||||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
2781074|NCT00662025|Secondary|AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.~5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants(Cohort 1).~n=Number of participants with analyzable data."|||nanogram∙hour/milliliter||Standard Deviation|Mean
2781075|NCT00662025|Secondary|Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 subjects (Cohort 1). n=Number of subjects with analyzable data.|||nanogram/milliliter||Standard Deviation|Mean
2781076|NCT00662025|Secondary|Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).~n=Number of participants with analyzable data."|||hours||Full Range|Median
2781077|NCT00662025|Secondary|AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.~The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||nanogram∙hour/milliliter||Standard Deviation|Mean
2781078|NCT00662025|Secondary|Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.~The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||nanogram/milliliter||Standard Deviation|Mean
2781079|NCT00662025|Secondary|Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||hours||Full Range|Median
2781080|NCT00662025|Secondary|Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).|||nanogram/milliliter||Standard Deviation|Mean
2781081|NCT00662025|Secondary|Overall Survival (OS)|OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.|A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||months||Full Range|Median
2781082|NCT00662025|Secondary|Time to Objective Tumor Response (TTR)|Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.~Twenty three participants with objective tumor response were analyzed for TTR."|||months||95% Confidence Interval|Median
2781083|NCT00662025|Secondary|Duration of Objective Tumor Response (DR)|Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.~Nineteen participants with objective tumor response were analyzed for DR."|||months||95% Confidence Interval|Median
2781084|NCT00662025|Secondary|Time to Tumor Progression (TTP)|Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all enrolled patients who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||months||95% Confidence Interval|Median
2781085|NCT00662025|Secondary|Progression-Free Survival (PFS)|Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||months||95% Confidence Interval|Median
2781106|NCT00661999|Secondary|Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL||16 Weeks||||Percentage of Participants|||Number
2781086|NCT00662025|Secondary|Number of Subjects With CBR Based on Investigator's Assessment|Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
2781087|NCT00662025|Secondary|Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment|Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
2781088|NCT00662025|Secondary|Number of Participants With Objective Response Based on Investigator's Assessment|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
2781089|NCT00662025|Primary|Number of Participants With Objective Response Based on Data Review Committee's Assessment|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|Full Analysis Set (FAS) is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.|||participants|||Number
2781090|NCT00662012|Secondary|Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .|Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.|5 years|Analysis per protocol|||participants|||Number
2781091|NCT00662012|Primary|The Primary Safety Endpoint - Frequency of Complications of Therapy|The primary safety endpoint is the frequency of complications of therapy|5 years|Analysis was per protocol|||participants|||Number
2781092|NCT00661999|Secondary|Transferrin Saturation at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks||||Percentage Saturation||Standard Deviation|Mean
2781093|NCT00661999|Secondary|Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16|MCV is a measure of the average red blood cell volume.|Baseline, 7 weeks and 16 weeks||||fL||Standard Deviation|Mean
2781094|NCT00661999|Secondary|Ferritin Level at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks||||µg/L||Standard Deviation|Mean
2781095|NCT00661999|Secondary|Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16||1 week, 7 weeks and 16 weeks||||mg/L||Standard Deviation|Mean
2781096|NCT00661999|Secondary|C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16||1 Week, 7 Weeks and 16 Weeks||||mg/L||Standard Deviation|Mean
2781097|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study|FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
2781098|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study|Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
2781099|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study|SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
2781100|NCT00661999|Secondary|Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)|Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks||||Scores on a scale||Standard Deviation|Mean
2781101|NCT00661999|Secondary|Time to First Red Blood Cell (RBC) Transfusions||16 weeks|Only 63 participants (20 DA + IV Iron, 21 DA + Oral Iron and 22 DA + Placebo) needed RBC transfusion during 16 weeks of treatment period. Thus, median of time to first RBC transfusion and 95 % confidence interval are not attainable.|||Days||95% Confidence Interval|Median
2781102|NCT00661999|Secondary|Time to Hematopoietic Response|Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 weeks||||Days||95% Confidence Interval|Median
2781108|NCT00661960|Primary|the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.|Duodenal tissue immune cell subsets were measured by flow cytometry.|nine months|all subjects who completed all study visits|||% CD3/CD4 T-cells in GALT tissue||Inter-Quartile Range|Median
2781109|NCT00661895|Secondary|New Onset Diabetes Mellitus||3 month intervals|||||||
2781110|NCT00661895|Primary|Percentage of Subjects Achieving Blood Pressure Goals|Percentage of subjects who achieved JNC-VII defined blood pressure goals.|3 month intervals||||percentage of participants|||Number
2781111|NCT00661830|Secondary|Time to Objective Response|Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.|one year|All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis|||days||95% Confidence Interval|Median
2781112|NCT00661830|Secondary|Best Overall Response|"Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks.~Two objective status determinations of CR before progression are required for a best response of CR.~Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR.~Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment."|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.|||participants|||Number
2781113|NCT00661830|Secondary|Overall Survival|Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis|||days||95% Confidence Interval|Median
2781114|NCT00661830|Primary|Progression-free Survival (PFS)|The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.|||days||95% Confidence Interval|Median
2781115|NCT00661778|Secondary|1-year Survival|The probability of surviving 1 year was estimated using the Kaplan-Meier method.|Baseline to 1 year|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2781116|NCT00661778|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.|||Months||95% Confidence Interval|Median
2781117|NCT00661778|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 4 years)|||||||
2781118|NCT00661778|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 4 years)|Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.|||Percentage of participants|||Number
2781119|NCT00661778|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.|||Months||95% Confidence Interval|Median
2781120|NCT00661726|Primary|Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||g/dL||Standard Error|Mean
2781121|NCT00661726|Secondary|Change in Percentage of Annexin-positive Cells From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||% of Annexin-Positive Cells||Standard Error|Mean
2781122|NCT00661726|Secondary|Change in Percentage of Red Blood Cell (RBC) Hb Concentration From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||% of RBC Hb Concentration||Standard Error|Mean
2783350|NCT00641706|Secondary|Overall Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Patients that started treatment.|||months||Full Range|Median
2781123|NCT00661726|Secondary|Change in Red Blood Cell (RBC) Deformability From Baseline to Peak (the Follow-up Time Point With the Highest Value)|Deformability was assessed by ektacytometry. Normal RBC have maximal deformability, measurable by osmotic ektacytometry, at isotonicity (290 mosmol). A decrease on the Deformability Index (measured in arbitrary units) corresponds to an impairment in the cell membrane's ability to alter its shape under stress.|up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||Arbitrary Units||Standard Error|Mean
2781124|NCT00661726|Secondary|Change in Neutrophil Counts From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||X (10^9)/L||Standard Error|Mean
2781125|NCT00661726|Secondary|Change in Platelet Count From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||X (10^9)/L||Standard Error|Mean
2781126|NCT00661726|Secondary|Change in Erythropoietin Levels From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||mIU/mL||Standard Error|Mean
2781127|NCT00661726|Secondary|Change in Absolute Reticulocyte Count From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||X (10^9)/L||Standard Error|Mean
2781128|NCT00661726|Secondary|Change in Serum Lactate Dehydrogenase (LDH) From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||U/L||Standard Error|Mean
2781129|NCT00661726|Secondary|Change in Indirect Bilirubin From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||µmol/L||Standard Error|Mean
2781130|NCT00661726|Primary|Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||participants|||Number
2781131|NCT00661726|Secondary|Change in Absolute Fetal Hemoglobin (HbF) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.|||g/dL||Standard Error|Mean
2781132|NCT00661713|Post-Hoc|Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against M10713 strain at 1 month after second dose of vaccination (Month 3)|At one month after second dose (Month 3)|Analysis was performed as per the protocol dataset. Only groups rMenB01 and rMenB02 are applicable to this endpoint as the post-hoc outcome was assessed at an interval of 1 month (rMenB01) or 2 months (rMenB02 ) to kill M10713 strain.|||Percentage of subjects||95% Confidence Interval|Number
2781133|NCT00661713|Secondary|Number of Subjects Reporting Unsolicited AEs Throughout the Study.|Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.|Throughout the study|Analysis was performed as per the safety dataset.|||participants|||Number
2781134|NCT00661713|Secondary|GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination|Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2781135|NCT00661713|Secondary|GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||IU/ml||95% Confidence Interval|Geometric Mean
2781136|NCT00661713|Secondary|Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2781137|NCT00661713|Secondary|Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
2781138|NCT00661713|Secondary|Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.|Month-1, month-2, month-3 and month-7|Analysis was performed as per the protocol dataset.|||percentage of Subjects||95% Confidence Interval|Number
2781139|NCT00661713|Secondary|Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.|at baseline, month-1, month-2, month-3, month-6 and month-7.|Analysis was performed as per the protocol dataset.|||percentage of Subjects||95% Confidence Interval|Number
2781140|NCT00661713|Secondary|Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.|Month-6 & 7|Analysis was performed as per the protocol dataset.|||percentage of Subjects||95% Confidence Interval|Number
2781141|NCT00661713|Primary|Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination|Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV|1 to 7 days after each vaccination|Analysis was performed as per the safety dataset.|||participants|||Number
2781312|NCT00661037|Secondary|Severe Intra-operative Complications|including: cardiopulmonary arrest, transient ischemic attack or stroke, cardiogenic shock, pulmonary edema, embolic event, anoxic coma, pericardial tamponade,death|Acute (ICD implant)||||Participants|||Count of Participants
2781142|NCT00661713|Primary|Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.|Month-1, 2, 3|Analysis was performed as per the protocol dataset|||percentage of Subjects||95% Confidence Interval|Number
2781143|NCT00661687|Secondary|Lens Characteristics|Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.|Over all scheduled visits day 1 - 1 month|Over All Scheduled Visits, All Eligible, Dispensed Eyes|||Eyes|Participants||Number
2781144|NCT00661687|Secondary|LogMAR Visual Acuity|The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.|Mean over all visits - 1 day, 1 week, 1 month|All Eligible, Dispensed Eyes|||LogMAR|Participants|Standard Deviation|Mean
2781145|NCT00661687|Primary|Subjective Responses to Symptoms/Complaints|Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.|Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits|All eligible participants|||Visual Analogue Scale|Participants|Standard Deviation|Mean
2781146|NCT00661674|Secondary|SOWS Score|"The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.~The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal.~Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine"|Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)||||units on a scale (SOWS Scale)||Standard Error|Mean
2781147|NCT00661674|Primary|OOWS Score|"The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.~OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications.~Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups"|Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)||||units on a scale (OOWS Scale)||Standard Error|Mean
2781148|NCT00661661|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.|Baseline up to Week 288|Safety analysis set: all participants who received at least 1 dose of study medication in current study.|||Particiants|||Number
2781149|NCT00661661|Secondary|Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.|First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96|Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781150|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781151|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781348|NCT00660699|Primary|Incidence of Severe Toxicities|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0|1 month after completion of treatment (treatment lasts approximately 19 weeks)||||percentage of participants|||Number
2781152|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781153|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781154|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781155|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781156|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781157|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781158|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2799125|NCT00529542|Secondary|LDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
2781159|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781160|NCT00661661|Secondary|Change From Baseline in Swollen Joint Counts|Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Swollen joints||Standard Error|Mean
2781161|NCT00661661|Secondary|Change From Baseline in Tender/Painful Joint Counts|This was carried out on 68 joints. Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Tender/painful joints||Standard Error|Mean
2781162|NCT00661661|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781163|NCT00661661|Secondary|Change From Baseline in Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781164|NCT00661661|Secondary|Change From Baseline in Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS)."|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781165|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781166|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781177|NCT00661609|Secondary|Progression Free Survival (PFS)|Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Weeks||Full Range|Median
2781527|NCT00659607|Primary|Change From Baseline in SBP (Systolic Blood Pressure) at Week 2|Effect on decrease in systolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||mmHg||Standard Deviation|Mean
2781167|NCT00661661|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Units on a scale||Standard Error|Mean
2781168|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Percentage of participants|||Number
2781169|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Percentage of participants|||Number
2781170|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).|||Percentage of participants|||Number
2781171|NCT00661622|Secondary|Systemic Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression||||months||95% Confidence Interval|Median
2781172|NCT00661622|Secondary|Median Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression||||months||95% Confidence Interval|Median
2781173|NCT00661622|Secondary|Overall Survival|Measured from the start of the treatment to death of patients|Baseline to death||||months||95% Confidence Interval|Median
2781174|NCT00661622|Primary|Overall Response Rate|Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.|Baseline then 3 to 4 weeks after every 2 treatments||||percentage of participants||90% Confidence Interval|Number
2781175|NCT00661622|Primary|Response of Liver Metastases|"Complete response: Disappearance of all target and non-target liver lesions~Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions~Stable disease: Absence of change which would qualify as response or progression~Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)"|Every 8 weeks||||participants|||Number
2781176|NCT00661609|Secondary|Overall Survival (OS)|Time in weeks from the first administration of study drug to death.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Weeks||Full Range|Median
2781225|NCT00661492|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|30 months|ITT population|||months||Full Range|Median
2781178|NCT00661609|Secondary|Duration of Objective Tumor Response (OTR)|Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)|Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)|||||||
2781179|NCT00661609|Secondary|Disease Control Rate (DCR)|Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).|8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Percentage of participants|||Number
2781180|NCT00661609|Primary|Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)|Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).|8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).|||Percengate of participants|||Number
2781181|NCT00661583|Secondary|Mean Change in Visual Acuity|Mean change in visual acuity in logMAR.|6 months||||logMAR||Full Range|Mean
2781182|NCT00661583|Secondary|Mean Change in in Intraocular Pressure.|Mean change in in intraocular pressure at 3 months and at 6 months|6 months||||mmHg||Full Range|Mean
2781183|NCT00661583|Secondary|Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.|To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)|6 months||||percentage of subjects|||Number
2781184|NCT00661583|Primary|Assessment of Ocular Adverse Events|To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months|6 months||||Number of Reported Adverse Events|||Number
2781185|NCT00661570|Secondary|Reason for Replacement||At removal of prosthesis|1 patient had his Vega inappropriately removed and received a Provox2.|||patients|||Number
2781186|NCT00661570|Secondary|Ease of Insertion|The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.|assessed immediately after insertion procedure|All patients included for insertion evaluation|||insertions|||Number
2781187|NCT00661570|Secondary|Voice Quality|Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.|at 3 months or device change (whichever was first)|23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.|||Units on a scale||Standard Deviation|Mean
2781188|NCT00661570|Primary|Device Life Time|Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.|at replacement of voice prosthesis (maximum 1 year)|In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.|||days of use||Full Range|Median
2781189|NCT00661557|Secondary|Number of Subjects With Any Specific Adverse Events|"Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease).~Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately."|Day 0 to study month 6|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2781190|NCT00661557|Secondary|Number of Subjects Reporting Any Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Day 0 to study month 6|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2781191|NCT00661557|Secondary|Number of Subjects With Unsolicited Symptoms|An unsolicited symptom covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Up to one month post-vaccination (Month 1)|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2781192|NCT00661557|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0 to Day 3) period after vaccination|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.|||Participants|||Count of Participants
2781528|NCT00659607|Primary|Frequency of Adverse Events||Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients|||Number
2781193|NCT00661557|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) period after vaccination|This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.|||Participants|||Count of Participants
2781194|NCT00661557|Secondary|Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y|"Vaccine response defined as:~For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer"|One month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||Participants|||Count of Participants
2781195|NCT00661557|Secondary|Anti-tetanus Toxoid Antibody Concentrations|Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs).|Prior to (Day 0) and one month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2781196|NCT00661557|Secondary|Anti-meningococcal Polysaccharide (PS) Antibody Concentrations|For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs).|Prior to (Day 0) and one month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2781197|NCT00661557|Secondary|Meningococcal rSBA Titers|For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).|Prior to vaccination (Day 0)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2781198|NCT00661557|Primary|Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers|For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).|One month post-vaccination (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2781199|NCT00661544|Primary|Response Rate|Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.|3, 6 and 12 months||||Participants|||Number
2781200|NCT00661531|Secondary|Response Rate|Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)|6 months||||Participants|||Count of Participants
2781201|NCT00661531|Primary|Progression Free Survival|Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause|6 months||||Participants|||Count of Participants
2781202|NCT00661505|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period|Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.|Week 1 to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
2781203|NCT00661505|Secondary|Number of Participants With Reports of Anti-erythropoietin Antibodies|The number of participants with Anti-epoetin antibodies is presented.|Up to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
2781204|NCT00661505|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
2781205|NCT00661505|Secondary|Number of Participants Taking Concomitant Medications|The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.|||Number of participants|||Number
2781226|NCT00661492|Secondary|Median Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months|ITT population|||months||Full Range|Median
2781206|NCT00661505|Secondary|Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.|Baseline (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Millimeters of Mercury||Standard Deviation|Mean
2781207|NCT00661505|Secondary|Mean Change From Baseline in Weight at Week 16 and Week 24|Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||kilogram||Standard Deviation|Mean
2781208|NCT00661505|Secondary|Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24|Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||millimole/liter||Standard Deviation|Mean
2781209|NCT00661505|Secondary|Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24|Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||milligram/liter||Standard Deviation|Mean
2781210|NCT00661505|Secondary|Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24|Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Percentage of TSAT||Standard Deviation|Mean
2781211|NCT00661505|Secondary|Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24|Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||gram/liter||Standard Deviation|Mean
2781212|NCT00661505|Secondary|Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24|Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||micromole/Liter||Standard Deviation|Mean
2781213|NCT00661505|Secondary|Mean Change From Baseline in Ferritin at Week 16 and Week 24|Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||microgram/liter||Standard Deviation|Mean
2781214|NCT00661505|Secondary|Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24|Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Number of cells x 10^9/L||Standard Deviation|Mean
2781215|NCT00661505|Secondary|Mean Change From Baseline in Hemoglobin at Week 16 and Week 24|Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||g/dL||Standard Deviation|Mean
2781227|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Doubling Time|PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)]|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information|||months||Full Range|Median
2790940|NCT00587054|Primary|Overall Survival of Transplant Patients|Calculate the median overall survival of transplant patients|up to 6 years||||Days||Full Range|Median
2781216|NCT00661505|Secondary|Mean Change From Baseline in Hematocrit at Week 16 and Week 24|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||percentage of red blood cells||Standard Deviation|Mean
2781217|NCT00661505|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24|Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Femtoliter||Standard Deviation|Mean
2781218|NCT00661505|Secondary|Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least 1 dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||mcg||Standard Deviation|Mean
2781219|NCT00661505|Secondary|Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.|||Percentage of participants|||Number
2781220|NCT00661505|Secondary|Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.|EEP (Week 16 to Week 20)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.|||mcg||Standard Deviation|Mean
2781221|NCT00661505|Secondary|Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period|The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.|||days||Inter-Quartile Range|Median
2781222|NCT00661505|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available.|||Percentage of participants||95% Confidence Interval|Number
2781223|NCT00661505|Secondary|Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period|The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|The Intention to treat (ITT) population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.|||g/dL||Standard Deviation|Mean
2781224|NCT00661505|Primary|Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period|The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.|EEP (Week 16 to Week 24)|The per protocol (PP) population included all participants who received at least one dose C.E.R.A. and underwent a safety follow-up except who had < 3 recorded Hb values and had inadequate iron status during EEP, missed C.E.R.A administration during Weeks 16-24, and/or who withdrawn before the end of EEP.|||Percentage of participants||95% Confidence Interval|Number
2781229|NCT00661492|Secondary|Median Time to Prostate-specific Antigen (PSA) Progression|Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.|24 months|Patients with Prostate-specific antigen (PSA) Information|||Months||Full Range|Median
2781230|NCT00661492|Secondary|Objective Response Rate (ORR)|ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|24 months|Patients with solid tumors|||percentage of participants||95% Confidence Interval|Number
2781231|NCT00661492|Secondary|2-year Radiographically Evident Progression-free Survival (REPFS).|"Radiographic progression:~1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture)."|24 months.|Patients who received bone scans or had bone progression only (bone pain/pathologic fracture/palliative radiation).|||Probability of REPFS at 2-year||95% Confidence Interval|Number
2781232|NCT00661492|Primary|Median Time to Progression (TTP)|TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.|24 months|ITT population|||Months||Full Range|Median
2781233|NCT00661479|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, Month 6|Safety Population: all patients treated on Day 1|||Number of Letters Read Correctly||Standard Deviation|Mean
2781234|NCT00661479|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients treated on Day 1|||Number of Letters Read Correctly||Standard Deviation|Mean
2781235|NCT00661453|Secondary|Whole Body DEXA Scanning for Lean Body Mass and Total Bone Mineral Density/ Content||-2 weeks or time 0, 3 months, 6 months|||||||
2781236|NCT00661453|Secondary|Maximum Ulnar CMAP Amplitude/Area and MUNE||-2 weeks, time 0, 3 months, 6 months|||||||
2781237|NCT00661453|Secondary|Quantitative SMN mRNA and Protein Measures||-2 weeks, time 0 , 3 months, or 6 months|||||||
2781238|NCT00661453|Secondary|Functional Motor Assessments: TIMPSI Scores||-2 weeks, time 0, 3 months, 6 months|||||||
2781239|NCT00661453|Secondary|Primary Caregiver Functional Rating Scale for SMA Type I Subjects (PCFRS)||time 0, and monthly for 12 months|||||||
2781240|NCT00661453|Secondary|Time to Death or Ventilator Dependence (Defined as >16 Hours/Day)||monthly|||||||
2781241|NCT00661453|Primary|Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures)||-2 weeks, time 0, 3 months, 6 months|20 participants have baseline values, only 12 have 3 and 6 month values|||g||Standard Deviation|Mean
2781242|NCT00661453|Primary|Laboratory Safety Data||-2 weeks, + 2 weeks, 3 months, 6 months|||||||
2781243|NCT00661427|Secondary|The Total Number of Participants That Were Effected by Adverse Events.|Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.|at least weekly||||Participants|||Count of Participants
2781244|NCT00661427|Primary|Number of Patients With Overall Objective Response|Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam|Approximately every 8 weeks with imaging up to two years||||participants|||Number
2781245|NCT00661388|Secondary|Mean Change From Baseline in Transferrin Saturation Over Time|Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
2781246|NCT00661388|Secondary|Mean Change From Baseline in Ferritin Concentration Over Time|Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||mcg/L||Standard Deviation|Mean
2781401|NCT00660543|Primary|Mean Cerebral Blood Volume (CBV)|Radiographical progression is determined based on RANO criteria.|At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)|All patients with treated GMB showed apparent tumor progression on conventional MR images.|||mL/g||Standard Deviation|Mean
2781247|NCT00661388|Secondary|Mean Change From Baseline in Creatinine Concentration Over Time|Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 32, 40|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Micromole/L||Full Range|Median
2781248|NCT00661388|Secondary|Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time|Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Micromole /L||Standard Deviation|Mean
2781249|NCT00661388|Secondary|Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time|Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Millimoles /L||Standard Deviation|Mean
2781250|NCT00661388|Secondary|Mean Change From Baseline in C-Reactive Protein Concentration Over Time|Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Milligrams /L||Standard Deviation|Mean
2781251|NCT00661388|Secondary|Mean Change From Baseline in Albumin Concentration Over Time|Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||g/L||Standard Deviation|Mean
2781252|NCT00661388|Secondary|Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time|Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||10^9 cells/Liter (L)||Standard Deviation|Mean
2781253|NCT00661388|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time|Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Femtoliters||Standard Deviation|Mean
2781254|NCT00661388|Secondary|Mean Change From Baseline in Hematocrit Level Over Time|Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||Fraction||Standard Deviation|Mean
2781255|NCT00661388|Secondary|Mean Change From Baseline in Hb Concentration Over Time|Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.|||g/dL||Standard Deviation|Mean
2781256|NCT00661388|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
2781529|NCT00659607|Primary|Unexpected Adverse Events|Occurrence status of unexpected adverse events|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients|||Number
2781257|NCT00661388|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Study Period|Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants who entered a particular phase is determined by ‘n’.|||Number of participants|||Number
2781258|NCT00661388|Secondary|Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP|Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|Weeks 0 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||Percentage of participants|||Number
2781259|NCT00661388|Secondary|Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP|Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||Days||Standard Deviation|Mean
2781260|NCT00661388|Secondary|The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP|The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up variable were included. Participants with less than three recorded Hb values during EEP; participants missing administration of C.E.R.A. during weeks 28-36; participants with inadequate iron status, were excluded.|||Percentage of participants||95% Confidence Interval|Number
2781261|NCT00661388|Secondary|Mean Time to Achievement of Response During the EEP|Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||Days||Standard Deviation|Mean
2781262|NCT00661388|Primary|Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period|Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.|From Baseline (Week 0) to EEP (Week 29 to Week 36)|Per protocol (PP) population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.|||g/dL||Standard Deviation|Mean
2781263|NCT00661362|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response|Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.|||Percentage of participants|||Number
2781264|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.|||mg*min/dL||Standard Error|Mean
2781265|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.|||mmol*min/L||Standard Error|Mean
2781266|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement|||mg/dL||Standard Error|Mean
2781267|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement|||mmol/L||Standard Error|Mean
2781268|NCT00661362|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.|||percent||Standard Error|Mean
2781269|NCT00661271|Secondary|Quality of Life|Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety.|assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported||||units on a scale||Standard Deviation|Mean
2781270|NCT00661271|Primary|Mindful Attention and Awareness Scale (MAAS)|"Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness~Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism~Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior"|assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported||||units on a scale||Standard Deviation|Mean
2781271|NCT00661258|Primary|Mean Adherence, as Measured by Electronic Drug Monitors (EDM)|We used the electronic drug monitors (EDM) adherence metric that was found to be most strongly associated with viral suppression (HIV RNA <400 copies/ml) in analysis of the pre-intervention data, EDM 'proportion taken within dose time' (see Gill et al, 2009). This measure estimated monthly adherence as the proportion of prescribed doses taken on time, e.g., within 1 hour of scheduled dose time ([number of doses taken ±1 hour of dose time] / [total number of prescribed doses]).|Month 12 (last month of 6-month intervention period) and 6-month post-intervention period|Of 68 subjects randomized at 6 months, 64 completed the full 12 months of data collection, 31 in Intervention Arm and 33 in Comparison Arm.|||percentage of doses taken on time||Standard Deviation|Mean
2781272|NCT00661258|Secondary|Change in CD4 Count|Mean change in CD4 count (cells/µL) between Month 6 and Month 12 (pre-intervention vs. last month of intervention)|Month 6, Month 12||||cells/µL||Standard Deviation|Mean
2781273|NCT00661193|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|From date of registration to 3 years or death, whichever comes first|Although 33 patients were eligible for Erlotinib Hydrochloride, only 32 were evaluable for response due to one patient not having measurable disease at baseline.|||participants|||Number
2781274|NCT00661193|Primary|Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months||From date of registration to 3 years or death, whichever comes first||||months||95% Confidence Interval|Median
2781275|NCT00661141|Secondary|PK of Acetaldehyde: T1/2||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Standard Deviation|Mean
2781276|NCT00661141|Secondary|PK of Acetaldehyde: AUC%Extrap||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||percentage||Standard Deviation|Mean
2781277|NCT00661141|Secondary|PK of Acetaldehyde: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr/mg||Standard Deviation|Mean
2781278|NCT00661141|Secondary|PK of Acetaldehyde: AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr||Standard Deviation|Mean
2781279|NCT00661141|Secondary|PK of Acetaldehyde: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr/mg||Standard Deviation|Mean
2781280|NCT00661141|Secondary|PK of Acetaldehyde: AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM*hr||Standard Deviation|Mean
2781281|NCT00661141|Secondary|PK of Acetaldehyde: Tmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Full Range|Median
2781282|NCT00661141|Secondary|PK of Acetaldehyde: DN Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM/mg||Standard Deviation|Mean
2781283|NCT00661141|Secondary|PK of Acetaldehyde: Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||µM||Standard Deviation|Mean
2781284|NCT00661141|Secondary|PK of Ethanol: Vz/F||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||dL||Standard Deviation|Mean
2781285|NCT00661141|Secondary|PK of Ethanol: CL/F||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||dL/hr||Standard Deviation|Mean
2781286|NCT00661141|Secondary|PK of Ethanol: T1/2||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||hours||Standard Deviation|Mean
2781287|NCT00661141|Secondary|PK of Ethanol: AUC%Extrap||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||percentage||Standard Deviation|Mean
2781288|NCT00661141|Secondary|PK of Ethanol: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||(mg*hr/dL)/mg||Standard Deviation|Mean
2781289|NCT00661141|Secondary|PK of Ethanol: AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||mg*hr/mL||Standard Deviation|Mean
2781290|NCT00661141|Secondary|PK of Ethanol: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||(mg*hr/dL)/mg||Standard Deviation|Mean
2781291|NCT00661141|Secondary|PK of Ethanol: AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||mg*hr/dL||Standard Deviation|Mean
2781292|NCT00661141|Secondary|PK of Ethanol: Tmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Full Range|Median
2781293|NCT00661141|Secondary|PK of Ethanol: DN Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||(mg/dL)/mg||Standard Deviation|Mean
2781294|NCT00661141|Secondary|PK of Ethanol: Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||mg/dL||Standard Deviation|Mean
2790982|NCT00586716|Secondary|Negative B and T Cell Crossmatch||1year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.||||||
2781295|NCT00661141|Secondary|PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||Liters||Standard Deviation|Mean
2781296|NCT00661141|Secondary|PK of 4-MP: Apparent Clearance (CL/F)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||L/hr||Standard Deviation|Mean
2781297|NCT00661141|Secondary|PK of 4-MP: Half-Life (T1/2)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||hours||Standard Deviation|Mean
2781298|NCT00661141|Secondary|PK of 4-MP: Percentage of AUC0-∞ Obtained by Extrapolation (AUC%Extrap)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||percentage||Standard Deviation|Mean
2781299|NCT00661141|Secondary|PK of 4-MP: DN AUC(0-∞)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||(ng*hr/mL)/mg||Standard Deviation|Mean
2781300|NCT00661141|Secondary|PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞])||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.|||ng*hr/mL||Standard Deviation|Mean
2781301|NCT00661141|Secondary|PK of 4-MP: DN AUC(0-t)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||(ng*hr/mL)/mg||Standard Deviation|Mean
2781302|NCT00661141|Secondary|PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t])||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||ng*hr/mL||Standard Deviation|Mean
2781303|NCT00661141|Secondary|PK of 4-MP: Time to Cmax (Tmax)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||hours||Full Range|Median
2781304|NCT00661141|Secondary|PK of 4-MP: Dose-Normalized (DN) Cmax||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment||||(ng/mL)/mg||Standard Deviation|Mean
2781305|NCT00661141|Secondary|Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax)||Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment|Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.|||ng/mL||Standard Deviation|Mean
2781306|NCT00661141|Primary|Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|AEs were collected to evaluate the safety and tolerability of oral Antizol with concomitant ethanol administration in particitpants with symptoms of acetaldehyde toxicity associated with altered ethanol metabolism. AE: any untoward medical event that occurs following the first administration of study medication until the study participant's last study visit, whether or not the event is considered drug related. SAE: an event that meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of an exposed subject; is medically significant or an important medical event as assessed by investigator or sponsor; is, in the opinion of the investigator, an important medical event.|Study Day 0 through Study Visit Day 7||||Participants|||Count of Participants
2781307|NCT00661089|Primary|Change in Pain Rating From Baseline to Four Weeks|Change scores from patient ratings VAS on mm scale for worst pain, averaged over a week for ratings performed at baseline and week four. Scale range 0-100 mm. 0= No pain, 100= worst pain|baseline and four weeks||||units on a scale 0-100mm||Inter-Quartile Range|Median
2781308|NCT00661089|Secondary|Ability to Perform Hygiene Rating||2,4,12, and 16 weeks|||||||
2781309|NCT00661089|Secondary|Time to Don a Pull Over Shirt||2,4,12, and 16 weeks|||||||
2781310|NCT00661089|Secondary|Change in Disability Assessment Scale for Hygiene|Subject rating of scores on the Disability Assessment Scale Range 0-3, 0= no disability, 3= severe disability|baseline and 4 weeks post injection||||units on a scale from 0-3||Inter-Quartile Range|Median
2781313|NCT00661037|Primary|Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up|"Severe implant-related* complications at ICD implants among the following:~Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation.~Transient ischemic attack or stroke,~Cardiogenic shock,~Pulmonary edema,~Embolic events,~Anoxic coma~Pericardial tamponade~Death.~Events at follow up:~Sudden cardiac death (defined as witnessed unexpected death occurring <1 hour from symptoms onset or unwitnessed during sleep)~Resuscitation after ineffective documented appropriate ICD shocks~Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure."|2 years||||Participants|||Count of Participants
2781314|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)||||ng*h/mL||Standard Deviation|Mean
2781315|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng*h/mL||Standard Deviation|Mean
2781316|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng*h/mL||Standard Deviation|Mean
2781317|NCT00660985|Primary|Tmax (hr) at Day 30|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 20 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 30.|||hours||Standard Deviation|Mean
2781318|NCT00660985|Primary|Tmax (hr) at Day 15|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 23 subjects in the Differin Gel 0.3% and 7 subjects in the Differin Gel 0.1% were detectable at Day 15.|||hours||Standard Deviation|Mean
2781319|NCT00660985|Primary|Tmax (hr) at Day 1|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 14 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 1.|||hours||Standard Deviation|Mean
2781320|NCT00660985|Primary|Cmax (ng/mL) at Day 30|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)||||ng/mL||Standard Deviation|Mean
2781321|NCT00660985|Primary|Cmax (ng/mL) at Day 15|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng/mL||Standard Deviation|Mean
2781322|NCT00660985|Primary|Cmax (ng/mL) at Day 1|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)||||ng/mL||Standard Deviation|Mean
2781323|NCT00660907|Secondary|Proportion of Participants With Body Weight Reduction of at Least 5%|To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2781324|NCT00660907|Secondary|Proportion of Participants With at Least One Episode of Hypoglycemia|To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 52|Full analysis set|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2781325|NCT00660907|Secondary|Adjusted Mean Change in Body Weight|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2781326|NCT00660907|Primary|Adjusted Mean Change in HbA1c Levels|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values|||percent||95% Confidence Interval|Least Squares Mean
2781327|NCT00660829|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 Days||||Participants|||Number
2781328|NCT00660829|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Scores for a series of subscales are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days|ITT|||Units on a scale||Standard Deviation|Least Squares Mean
2781329|NCT00660829|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"Reflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days||||Scores on a scale||Standard Deviation|Least Squares Mean
2781330|NCT00660829|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days|ITT|||Scores on a scale||Standard Deviation|Least Squares Mean
2781331|NCT00660829|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||Scores on a scale||Standard Error|Least Squares Mean
2781332|NCT00660829|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14 days|ITT|||Scores on a scale||Standard Deviation|Least Squares Mean
2781333|NCT00660816|Secondary|Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)|Estimated based on number of evaluable patients with complete response, partial response or stable disease|36 months after enrollment of last patient|Patients with a complete response, partial response, stable disease, or progressive disease|||participants|||Number
2781334|NCT00660816|Secondary|Response Rate|Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution|36 months after enrollment of last evaluable patient|Patients with a complete response, partial response, stable disease, or progressive disease|||participants|||Number
2781335|NCT00660816|Secondary|Overall Survival|Measured from the date of randomization to the date of death, whichever occurs first and censored at the date of last followed for those survivors|36 months after enrollment of last patient||||Months||95% Confidence Interval|Median
2781336|NCT00660816|Primary|Progression-free Survival|From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.|18 months after enrollment of last patient||||Months||95% Confidence Interval|Median
2781337|NCT00660790|Primary|Change of Intima Media Thickness (IMT)|Change of IMT from Baseline to 24 months|24 months||||mm||Standard Deviation|Mean
2781338|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year|30 out of 48 participants completed all components of study treatment.|||percentage of participants||95% Confidence Interval|Number
2781339|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of study treatment.|||months||95% Confidence Interval|Median
2781340|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|2 years||||percentage of participants||95% Confidence Interval|Number
2781341|NCT00660699|Post-Hoc|Incidence of Disease Recurrence||Median follow-up was 24 months (range 3.2-97 months)||||percentage of participants|||Number
2781342|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year||||percentage of participants||95% Confidence Interval|Number
2781343|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)||||months||95% Confidence Interval|Median
2781344|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of the study therapy.|||months||95% Confidence Interval|Median
2781345|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)||||months||95% Confidence Interval|Median
2781346|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 3-4)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)||||percentage of participants|||Number
2781347|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 1-2)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)||||percentage of participants|||Number
2781349|NCT00660660|Secondary|Monetary Value of Work Hours Saved|The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).|Week 4|Results based on MITT population with available data for this outcome measure.|||Monetary value (US dollars)||Standard Deviation|Least Squares Mean
2781350|NCT00660660|Secondary|Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)|"To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, no difficulty to 3, severe difficulty. Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance."|Baseline and 4 weeks||||Percentage||Standard Deviation|Mean
2781351|NCT00660660|Secondary|Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)|Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage||Standard Deviation|Mean
2781352|NCT00660660|Secondary|Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)|Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage||Standard Deviation|Mean
2781353|NCT00660660|Secondary|Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)||4 weeks|Results based on MITT population with available data for this outcome measure.|||Work hours||Standard Deviation|Mean
2781354|NCT00660660|Secondary|Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.|Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781355|NCT00660660|Secondary|Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21-28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781356|NCT00660660|Secondary|Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781357|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781358|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781359|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781360|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781361|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781530|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 36 Months||initiation and 36 months|The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded.|||mmHg||Standard Deviation|Mean
2781362|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781363|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781364|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response."|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781365|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781366|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781367|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781368|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781369|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781370|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781371|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781372|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781373|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781374|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781375|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781376|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|1 week|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781377|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781378|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781379|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|2 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781380|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of None on 7 consecutive days."|1 week||||Percentage of participants|||Number
2781381|NCT00660660|Secondary|Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7‑consecutive-day period during which the patient's daily diary response was No (did not have trouble sleeping due to GERD symptoms).'"|4 weeks|Results based on MITT population with available data for this outcome measure.|||Days||Full Range|Median
2781382|NCT00660660|Secondary|Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Relief of sleep disturbances associated with GERD was defined as a daily diary response of Yes on not more than 2 of 7 consecutive days."|4 weeks||||Days||Full Range|Median
2781383|NCT00660660|Secondary|Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Relief of sleep disturbances associated with GERD was defined as a daily diary response of Yes on not more than 2 of 7 consecutive days, and 'days to first relief' was defined as the first day of the 7 days that reached relief of sleep disturbance."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Days||Full Range|Median
2781384|NCT00660660|Secondary|Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer Yes or No to the question, Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD? in the diary card.'"|4 weeks|Results based on MITT population with available data for this outcome measure.|||Percentage of days||Standard Deviation|Mean
2781385|NCT00660660|Secondary|Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Relief of sleep disturbances associated with GERD was defined as a daily diary response of Yes on not more than 2 of 7 consecutive days."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of Participants|||Number
2781399|NCT00660595|Primary|Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)|PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms).|baseline and 3 weeks||||units on a scale|||Number
2781386|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Relief of sleep disturbances associated with GERD was defined as a daily diary response of Yes on not more than 2 of 7 consecutive days."|4 weeks|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
2781387|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Relief of sleep disturbances associated with GERD was defined as a daily diary response of Yes on not more than 2 of 7 consecutive days."|2 weeks|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
2781388|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Relief of sleep disturbances associated with GERD was defined as a daily diary response of Yes on not more than 2 of 7 consecutive days."|1 week|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
2781389|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
2781390|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?. Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of No on 7 consecutive days during 4 weeks of treatment."|4 weeks||||Participants|||Number
2781391|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of No on 14 consecutive days."|2 weeks||||Participants|||Number
2781392|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.|"The assessment was based on patients registrations of the answers Yes or No to the question: Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of No on 7 consecutive days."|1 week||||Participants|||Number
2781393|NCT00660660|Secondary|Achievement of Developer-defined Good Sleep|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with ‎Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4|4 weeks|Results based on MITT population with available data for this outcome measure.|||Participants|||Number
2781394|NCT00660660|Secondary|Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline|"To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, no difficulty to 3, severe difficulty. Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance."|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.|||Scores on a scale||Standard Deviation|Least Squares Mean
2781395|NCT00660660|Primary|Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.|"Relief of nighttime heartburn on patient's last 7 days in the study. Relief was defined as a daily diary card response of none or 0, on at least 6 of 7 days, allowing for one mild or 1 response. Diary card scale (none, mild, moderate, severe)."|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.|||Percentage of participants|||Number
2781396|NCT00660595|Secondary|Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)|PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).|baseline and 3 weeks||||units on a scale|||Number
2781397|NCT00660595|Secondary|Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)|The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16).|baseline and 3 weeks||||units on a scale|||Number
2781398|NCT00660595|Secondary|Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks)|The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment|baseline and 3 weeks||||units on a scale|||Number
2781402|NCT00660517|Secondary|Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.|day 1 to day 14|Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
2781403|NCT00660517|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in the 12 hour instantaneous total nasal symptoms score(iTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value."|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
2781404|NCT00660517|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in the 12 hour reflective total nasal symptoms score(rTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.|day 1 to day14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
2781405|NCT00660504|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|participants were followed for the duration of the study, an average of 12 weeks||||percentage of participants|||Number
2781406|NCT00660504|Secondary|Progression-Free Survival||1.5 years after last subject enrolled||||month||95% Confidence Interval|Median
2781407|NCT00660504|Other Pre-specified|Overall Survival at 6 and 12 Months||6 and 12 months.||||percentage of patients||95% Confidence Interval|Number
2781408|NCT00660504|Primary|Overall Survival||1.5 years after last subject enrolled||||month||95% Confidence Interval|Median
2781409|NCT00660400|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival for all participants at one year after first dose of 5-azacitidine (Vidaza). Overall survival was calculated by the method of Kaplan-Meier with standard errors computed using Greenwood's formula.|One year|Participants who proceeded to allogeneic HCT|||percentage of participants||95% Confidence Interval|Number
2781410|NCT00660400|Secondary|Percentage of Participants Who Proceed to Hematopoietic Cell Transplantation (HCT)|Proportion of patients enrolled who subsequently proceeded to allogeneic HCT.|Up to 3 years|All participants|||percentage of participants|||Number
2781411|NCT00660400|Secondary|Overall Response Rate (ORR)|Pre-allogeneic HCT responses to 5-azacitidine (Vidaza), based on the International Working Group criteria: Complete Remission (CR); Partial Response (PR); Stable Disease (SD). Point estimates and 95% confidence intervals were calculated for the response rate to 5-azacitidine, evaluated at marrow evaluation after 4 cycles of 5-azacitidine or prior to HCT whichever came first. CR: Bone marrow with 5% myeloblasts and normal maturation of all cell lines. PR: All CR criteria if abnormal before treatment except bone marrow blasts decreased by 50% over pretreatment but still > 5%. SD: Failure to attain CR, PR, relapsed (or progressive) disease.|At the end of up to six (28 day) cycles of 5-azacitidine|Participants who proceeded to allogeneic HCT|||percentage of participants|||Number
2781412|NCT00660400|Primary|Percentage of Participants With Relapse-free Survival (RFS)|Relapse-free survival one year after allogeneic HCT in MDS patients receiving at least one complete cycle of 5-azacitidine (Vidaza) in the pre-transplantation setting. Relapsed disease: if with complete remission (CR) - greater than 5% blasts in bone marrow; if with partial response (PR) - greater than 30% increase in blasts in the marrow; if with stable disease (SD) - return to pretreatment peripheral blood levels and transfusion requirements due to disease.|One year post allogeneic HCT|Participants who proceeded to allogeneic HCT|||percentage of participants||95% Confidence Interval|Number
2781413|NCT00660387|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
2781414|NCT00660387|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
2781415|NCT00660387|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781531|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 36 Months||initiation and 36 months|The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded.|||mmHg||Standard Deviation|Mean
2790983|NCT00586716|Primary|Elimination of Donor Specific Antibodies||1 year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.||||||
2781416|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781417|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV was totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
2781418|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781419|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
2781420|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781421|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781422|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781423|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781432|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781424|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781425|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781426|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781427|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781428|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781429|NCT00660387|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781430|NCT00660387|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781431|NCT00660387|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781504|NCT00659789|Secondary|Effect of Vacc-4x on CD8 Counts|CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52|Weeks 6,18,24,28,32,36,40,44,48,52.|Subject who stopped ART at week 28 and remained off ART until week 52|||cells/µL||Inter-Quartile Range|Median
2781433|NCT00660387|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2781434|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2781435|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as On time without dyskinesia and On time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
2781436|NCT00660387|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
2781437|NCT00660348|Primary|Number of Subjects Per Arm With Decrease in Pain Scores|The primary objective of this study is to compare the effectiveness of pain control between intrathecal opioid delivery and standard analgesia delivery method in patients with locally advanced unresectable or metastatic pancreatic cancer. The primary end point is the number of subjects on each arm showing a decrease in the change in VAS self-assessment pain intensity rating (VAS pain rating) at one month from initial treatment with respect to the baseline pain score. The change is defined as (the Pain Score at one month of the treatment - the Pain Score at baseline). Serial pain scores will be collected at all assessment time points. Min: zero cm. Max 10cm. A higher value means worse pain. Subjects on each arm will report pain on a 10 cm Visual Analogue Scale (VAS) pain rating scale, by making a mark on the 10cm horizontal line with a pen and study team will measure distance from the mark to the start of the scale, which will indicate pain score (eg 1 cm, 3 cm 6 cm, etc.).|1 month|One subject was enrolled, and baseline pain score was obtained on questionnaire, but the subject came off-study before follow-up pain score could be collected. Study terminated shortly thereafter. No outcome data were collected.||||||
2781438|NCT00660309|Secondary|Change From Baseline in Retinal Blood Flow After Aliskiren or Irbesartan|"Retinal blood flow was assessed using the laser Doppler technique. The blood flow in the superior temporal retinal artery in one of the eyes of each study participant was determined.~The Single dose effect of aliskiren or irbesartan was measured as the change/difference between Day 2 and baseline measurements.~The Multiple dose effect of aliskiren or irbesartan wsas measured as the change/difference between Day 15 and Day 2 measurements"|Baseline (Day 1), Day 2 and Day 15.|PD analysis set. This assessment was only conducted at sites with available Canon Laser Blood Flowmeter. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||µL/min||Standard Deviation|Mean
2781439|NCT00660309|Secondary|Change in Serum Aldosterone After Captopril, Aliskiren or Irbesartan|"The following serum aldosterone effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
2781440|NCT00660309|Secondary|Change in Plasma Angiotensin II After Captopril, Aliskiren or Irbesartan|"The following angiotensin II effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
2781441|NCT00660309|Secondary|Change in Plasma Angiotensin I After Captopril, Aliskiren or Irbesartan|"The following angiotensin I effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
2781442|NCT00660309|Secondary|Change in Plasma Renin Activity (PRA) After Captopril, Aliskiren or Irbesartan|"PRA was measured by the trapping method and the following effects assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 baseline / Day 2 baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
2781443|NCT00660309|Secondary|Change in Plasma Pro-renin Concentration After Captopril, Aliskiren or Irbesartan|"The following plasma pro-renin concentration effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
2781444|NCT00660309|Secondary|Change in Plasma Renin Concentration (PRC) After Captopril, Aliskiren or Irbesartan|"The following plasma renin concentration effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].|||ratio||95% Confidence Interval|Geometric Mean
2781445|NCT00660309|Secondary|Change From Single Dose Peak to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak - Day 2 peak GFR. Peak GFR was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781446|NCT00660309|Secondary|Change From Baseline to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781447|NCT00660309|Secondary|Change From Baseline to Steady State Trough in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781448|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781449|NCT00660309|Primary|Change From Single Dose Peak to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak - Day 2 peak. Peak RPF was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781450|NCT00660309|Primary|Change From Baseline to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak - Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781451|NCT00660309|Primary|Change From Baseline to Steady State Trough in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline - Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781452|NCT00660309|Primary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.|||mL/min/1.73m^2||Standard Deviation|Mean
2781453|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Captopril|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak - Day 1 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.|||mL/min/1.73m^2||Standard Deviation|Mean
2781454|NCT00660309|Secondary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Captopril|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak - Day 1 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.|||mL/min/1.73m^2||Standard Deviation|Mean
2781455|NCT00660192|Secondary|Number of Participants Satisfied With Treatment|"Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks||||participants|||Number
2781456|NCT00660192|Primary|Mean Number of Days of Decrease in Pain Level Using VAS|Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.|4 weeks||||days||Standard Deviation|Mean
2781457|NCT00660179|Other Pre-specified|Summary of the First Causes of Morbidity or Mortality|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).~Other worsening of PAH was defined by the combined occurrence of all the following 3 events:~At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.~AND worsening of PAH symptoms including at least one of the following:~a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy~AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (Up to 36 months)|All randomized patients|||participants|||Number
2781458|NCT00660179|Secondary|Cardiac Index at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study|||L/min/m^2||Full Range|Mean
2781459|NCT00660179|Secondary|Pulmonary Vascular Resistance at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study|||(dyn*sec/cm^5)||Full Range|Mean
2783379|NCT00641147|Secondary|Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)|Change in SSAT mean activity level at 8 months compared to baseline (time 0)|Baseline and 8 months||||pmol/acetylspermidine/mg protein/min||Standard Deviation|Mean
2781460|NCT00660179|Secondary|Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6|"Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.~Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.~Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.~Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA."|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis|||participants|||Number
2781461|NCT00660179|Secondary|Change From Baseline to Month 6 in 6-minute Walk Distance|The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis|||metres||Standard Deviation|Mean
2781462|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).|Up to end of study (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
2781463|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of treatment (plus 7 days)|Up to end of treatment (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
2781464|NCT00660179|Secondary|Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.|Up to end of treatment (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
2781465|NCT00660179|Primary|Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).~Other worsening of PAH was defined by the combined occurrence of all the following 3 events:~At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.~AND worsening of PAH symptoms including at least one of the following:~a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy~AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (data presented up to month 36)|All randomized patients|||percentage of participants-Kaplan Meier|||Number
2781466|NCT00660075|Primary|Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)||At the end of the two 6-week interventions|We analyzed all the subjects involved in the study. The analysis was per protocol. We compared data from the placebo phase with the sitagliptin phase.|||mmol*h/L||Standard Deviation|Mean
2781467|NCT00660049|Primary|Ease of Use for Patients|Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.|Baseline up to 31 days|All participants|||participants|||Number
2781468|NCT00660023|Secondary|Number of Blood Transfusions During the DTP and EEP|The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||blood transfusions|||Number
2781469|NCT00660023|Secondary|Number of Participants Receiving Blood Transfusion During the DTP and EEP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||participants|||Number
2781470|NCT00660023|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||percentage of participants|||Number
2781505|NCT00659789|Secondary|Immunogenicity|Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema|Week 1, week 18 and week 52|ITT Population|||participants|||Number
2781532|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded.|||mmHg||Standard Deviation|Mean
2781471|NCT00660023|Secondary|Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.|||mcg||Standard Deviation|Mean
2781472|NCT00660023|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.|||days||Standard Deviation|Mean
2781473|NCT00660023|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2781474|NCT00660023|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.|||g/dL||Standard Deviation|Mean
2781475|NCT00660023|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants from the ITT Population who fulfill inclusion/exclusion criteria per study protocol.|||percentage of participants||95% Confidence Interval|Number
2781476|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty.|||Percentage of subjects|||Number
2781477|NCT00660010|Other Pre-specified|Number of Pregnancies Reported by Subjects at Final Questionnaire|The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.|||Pregnancies|||Number
2781478|NCT00660010|Other Pre-specified|Number of Subjects Who Reported Pregnancies at Final Questionnaire|The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.|||Subjects|||Number
2781479|NCT00660010|Other Pre-specified|Number of Female Subjects Who Reported Regular Menses at Adulthood|Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.|||Subjects|||Number
2781480|NCT00660010|Other Pre-specified|Mean Time to or Mean Age at Regular Menses in Females After Treatment|Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.|Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)|During the posttreatment period, data were obtained from 32 female subjects. Twenty-seven subjects reported the start of menses, but only 26 subjects reported a menses start date.|||years||Standard Deviation|Mean
2781481|NCT00660010|Other Pre-specified|Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)|Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males.|Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)|For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66.|||cm||Standard Error|Mean
2781482|NCT00660010|Secondary|Mean Ratio of Bone Age to Chronological Age|Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.|Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.|||ratio||Standard Deviation|Mean
2781483|NCT00660010|Secondary|Mean Stimulated Testosterone Concentrations in Males|Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All males in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.|||ng/dL||Standard Deviation|Mean
2781484|NCT00660010|Secondary|Mean Stimulated Estradiol Concentrations in Females|Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All females in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.|||pg/mL||Standard Error|Mean
2781485|NCT00660010|Secondary|Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations|Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females and 6 males. Study drug was discontinued at the initiation of puberty.|||mIU/mL||Standard Deviation|Mean
2781486|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty.|||Percentage of subjects|||Number
2781487|NCT00659984|Secondary|Quality of Life|Patients (aged 5-18) and parents (of patients aged 2-18) were asked to complete the 23-item Pediatric Quality of Life InventoryTM (PedsQLTM). PedsQLTM consists of 4 scales (physical, emotional, social, school functioning) which are then averaged into an overall summary score (scale: 0-100 with 0 representing the worst possible Quality of Life overall summary score and 100 representing the best possible Quality of Life overall summary score). The mean difference between the post treatment overall summary score and the baseline overall summary score is reported.|Day 60 +/- 10 days post Therapeutic Dose|Self reported PedsQL™ scores were obtained for 9 patients in the ITT population (n=15) at baseline (prior to the start of the Ultratrace™ Iobenguane I 131 imaging studies) and at the end of therapy (60 ±10 days post treatment).|||units on a scale||Standard Deviation|Mean
2781488|NCT00659984|Secondary|Tumor Response in CT/MRI Lesions Post Therapeutic Treatment|Measurable disease was defined for a conventional CT scan by the presence of at least one lesion that could be accurately measured in at least one dimension with the longest diameter at least 20 mm by Independent Review. Efficacy success was defined as a patient achieving a Complete Response (CR)=disappearance of all target and non-target CT/MRI lesions; or, Very Good Partial Response (VGPR)=greater than 90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurement disease at study entry. Non-target CT/MRI lesions stable to smaller in size; or, Partial Response (PR)=at least 30% decrease in the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size.|Day 60 +/- 10 days post Therapeutic Dose|The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population.|||percentage of evaluable population||95% Confidence Interval|Number
2781506|NCT00659789|Secondary|Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths|Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.|Up to week 52|Safety Population|||participants|||Number
2781507|NCT00659789|Primary|Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.||From Week 28 to Week 52|ITT Population|||participants|||Number
2781489|NCT00659984|Secondary|Overall Objective Tumor Response Post Therapeutic Treatment|The International Neuroblastoma Response Criteria (INRC) were utilized as a basis for the overall response criteria, which incorporated responses in MIBG positive lesions,bone marrow disease, and CT/MRI lesions that met NANT-modified RECIST criteria. Efficacy success was defined as the proportion of pts who were successful overall [i.e., achieving a Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)] determined by independent reviewers. CR = Disappearance of all target lesions, homovanillic acid/ vanillylmandelic acid (HVA/VMA) normal (NL); VGPR = > 90% decr of disease for CT/MRI target lesions, all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD/CR in soft tissue lesions. CR in bone marrow, no new tumor sites, and NL HVA/VMA.; PR = At least 30% decr in disease measurement for CT/MRI target lesions. Bone marrow with CR, MIBG with either PR/CR in bone lesions, MIBG may be SD /CR in soft tissue lesions, and HVA/VMA may still be elevated.|Day 60 +/- 10 days post Therapeutic Dose|The evaluable population (which excludes non-evaluable responses) contains one patient less than the full ITT population.|||proportion of evaluable population||95% Confidence Interval|Number
2781490|NCT00659984|Secondary|Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions|The dosimetric endpoint was to estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following an imaging dose of 0.1 mCi/kg Ultratrace™ Iobenguane I 131. Biodistribution was assessed by determination of total body residence (TBR) time and by visual examination of whole body camera images. 3 timepoints were used, the 1st image was taken within 1hr after the imaging dose, the 2nd image was taken at ~24hr after imaging dose, the 3rd image was taken 2-5d after imaging dose. Whole body radiation absorbed dose estimates & kidney, liver, and lung were calculated using the Medical Internal Radiation Dose (MIRD) schema.TBR time is derived from time integration of curve-fitted injected activity across all 3 timepoints when the isotope is emitting radiation.Three points are sampled to estimate a singular value for each organ and tissue according to the commonly used methods of the Society of Nuclear Medicine and Molecular Imaging Committee on MIRD.|Day 5 post Dosimetric Dose|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection).|||Gy||Standard Deviation|Mean
2781491|NCT00659984|Secondary|Dose Limiting Toxicities|Dose limiting toxicities include treatment emergent adverse events (TEAEs) that were possibly, probably, or definitely related to Ultratrace™ Iobenguane I 131.|From the time of signed informed consent until Day 60 or until the end of therapy evaluation is completed (whichever comes first).|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131.|||number of DLTs|||Number
2781492|NCT00659984|Primary|Maximum Tolerated Dose|The maximum tolerated dose (MTD) was defined as the dose immediately below the level at which dose escalation would be stopped due to dose limiting toxicities (DLTs). Once the MTD was reached, an additional 3 patients were to be treated at that dose level, for a total of 6 patients at that planned dose level. DLTs were defined as any of the events that are possibly, probably or definitely attributable to UltratraceTM iobenguane I 131. The MTD was supposed to be the highest dose tested at which fewer than 1/3 of pts experience a DLT when 6 patients have been treated at the MTD but the dosimetry results indicated that the maximal dosage allowed to normal organs would be exceeded if the highest planned dose (21.0 mCi/kg) was administered, so the highest dose administered in the study was 18.6 mCi/kg .|Day 60 +/-10 or Engraftment, whichever comes first|A total of 15 patients underwent dosimetry (received a single imaging dose of Ultratrace™ Iobenguane I 131 injection) and all 15 patients later received a single therapeutic dose of Ultratrace™ Iobenguane I 131.|||mCi/kg|||Number
2781493|NCT00659945|Primary|Number of Participants Having Post-operative Emesis and Nausea.|Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.|48 hours post surgery||||participants|||Number
2781494|NCT00659880|Secondary|MRI Assessments|"MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn.~Images were also assessed for oedema in each of these 3 regions of the meniscus."|12 months||||participants|||Number
2781495|NCT00659880|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.|60 months||||units on a scale||Standard Deviation|Mean
2781496|NCT00659828|Secondary|Bone Mineral Density||Baseline, 58 months||||g/cm^2|||Number
2781497|NCT00659828|Secondary|Glucose Levels||Baseline, 58 months||||mg/dL|||Number
2781498|NCT00659828|Primary|Weight||Baseline, 58 months||||lbs|||Number
2781499|NCT00659815|Primary|Lens Deposits|Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.|Over-all study visits, baseline to 1-month|Lens deposits over all scheduled follow-up visits (all eligible, dispensed eyes with non-missing data)|||Eyes|Participants||Number
2781500|NCT00659815|Primary|Slit Lamp Findings|Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.|Over-all follow-up visits from baseline to1 month|Graded Slit Lamp Findings over All Follow-Up Visits (Any finding, All Dispensed Eyes, 151 + 2 possible).|||Eyes|Participants||Number
2781501|NCT00659815|Primary|Comfort|Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.|Over-all follow-up visits from baseline to 1 month|Symptoms/Complaints Over-All Scheduled Follow-Up Visits (All Eligible, Dispensed Eyes with non-missing scores)|||Units on a Scale|Participants|Standard Deviation|Mean
2781502|NCT00659789|Secondary|Effects on Vacc-4x on HIV-1 RNA||Weeks 24,28,32,36,40,44,48,52.||||copies/mL||Standard Deviation|Mean
2781503|NCT00659789|Secondary|Time to Restart of ART for Vacc-4x Subjects Versus Placebo|Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)|Between Week 28 to Week 52|ITT Population|||days||Standard Deviation|Mean
2781508|NCT00659737|Primary|Number of Participants With Postoperative Nausea and Vomiting||0-24 hours||||participants|||Number
2781509|NCT00659724|Primary|Dialyzer Assessment: Venous Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows:~Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: the assessment of the condition of the venous header after rinse-back||||Number of Dialyzers|Dialyzers||Number
2781510|NCT00659724|Primary|Dialyzer Assessment: Arterial Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows:~Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: assessment of the condition of the arterial header after rinse-back||||Number of Dialyzers|Dialyzers||Number
2781511|NCT00659724|Primary|Dialyzer Assessment: Fiber Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows:~Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)"|Each treatment: assessment of the condition of the dialyzer fibers after rinse-back||||Number of Dialyzers|Dialyzers||Number
2781512|NCT00659724|Primary|Ease of Use: Priming Dialysate Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows:~Dialysate Side at 500 ml Priming Volume (check one):~Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air."|Priming at each treatment||||Number of Dialyzers|Dialyzers||Number
2781513|NCT00659724|Primary|Ease of Use: Priming Blood Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows:~Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air.~Very Difficult:Air could not be removed."|Priming at each treatment||||Number of Dialyzers|Dialyzers||Number
2781514|NCT00659633|Primary|Pain Perception|"Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.~The mechanical slide algometer [Price et al. (1994)] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale."|Participants will be followed from baseline through 128 minutes||||units on a scale||Standard Error|Mean
2781515|NCT00659607|Secondary|Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients~40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients|||Percentage of patients|||Number
2781516|NCT00659607|Secondary|Baseline Severity of Hypertension Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients~Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
2781517|NCT00659607|Secondary|Previous Medication Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
2781518|NCT00659607|Secondary|Medical History Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
2781519|NCT00659607|Secondary|Concomitant Disease Factors Affecting the Safety Profile|Occurrence status of adverse events by Concomitant disease of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients||95% Confidence Interval|Number
2781520|NCT00659607|Secondary|Medical History Factors Affecting the Safety Profile|Occurrence status of adverse events by medical history of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment|||Percentage of patients||95% Confidence Interval|Number
2781521|NCT00659607|Primary|Effective Rate|"Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:~Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)~Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||Percentage of patients|||Number
2781522|NCT00659607|Primary|Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2|Effect on decrease in diastolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment|||mmHg||Standard Deviation|Mean
2781523|NCT00659607|Secondary|Treatment Type Factors Affecting the Safety Profile|Occurrence status of adverse events by Treatment type of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients|||Percentage of patients||95% Confidence Interval|Number
2781524|NCT00659607|Secondary|Proportion of Geriatric Population Factor Affecting the Safety Profile|Occurrence status of adverse events by Proportion of geriatric population of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients|||Percentage of patients||95% Confidence Interval|Number
2781525|NCT00659607|Secondary|Age Factors Affecting the Safety Profile|Occurrence status of adverse events by Age category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients|||Percentage of patients||95% Confidence Interval|Number
2781526|NCT00659607|Secondary|Gender Factors Affecting the Safety Profile|Occurrence status of adverse events by Gender category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients|||Percentage of patients||95% Confidence Interval|Number
2781533|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded.|||mmHg||Standard Deviation|Mean
2781534|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded.|||mmHg||Standard Deviation|Mean
2781535|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded.|||mmHg||Standard Deviation|Mean
2781536|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 6 Months||initiation and 6 months|The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded.|||mmHg||Standard Deviation|Mean
2781537|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 6 Months||initiation and 6 months|The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded.|||mmHg||Standard Deviation|Mean
2781538|NCT00659581|Primary|Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events||3 years after initiation of treatment|All of observed 20,443 patients were included as intention to treat set|||Number of participants|||Number
2781539|NCT00659529|Secondary|Serum Sildenafil Levels||Pre/during therapy|||||||
2781540|NCT00659529|Secondary|CFQ-R||Pre/post therapy|||||||
2781541|NCT00659529|Secondary|Exhaled Breath Condensate pH||Pre/post therapy|||||||
2781542|NCT00659529|Primary|Sputum Elastase||Pre/post therapy|Subjects who completed 6 weeks of sildenafil and had available data for pre/post 6 weeks of sildenafil were analyzed. One subject presented to the final study visit with 1 week of previously unreported symptoms consistent with pulmonary exacerbation, and therefore, efficacy data was not analyzed on that subject as pre-specified in the protocol.|||micrograms/mL||95% Confidence Interval|Mean
2781543|NCT00659490|Secondary|Time to Max Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
2781544|NCT00659490|Secondary|Time to Max Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
2781545|NCT00659490|Secondary|Time to Max Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
2781546|NCT00659490|Secondary|Time to Max Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||minutes||Standard Deviation|Mean
2781547|NCT00659490|Secondary|Time to Max Deterioration in VAMS Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||Minutes||Standard Deviation|Mean
2781548|NCT00659490|Secondary|Maximum Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included. The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781549|NCT00659490|Secondary|Maximum Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781550|NCT00659490|Secondary|Maximum Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781551|NCT00659490|Secondary|Maximum Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781552|NCT00659490|Secondary|Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781553|NCT00659490|Secondary|Number of Patients Requesting Rescue Medication|Observed case.|End of surgery up to 8hours following surgery|The analyses are based on a per-protocol population.|||Participants|||Number
2781554|NCT00659490|Secondary|Time to First Intake of Rescue Medication.||From end of surgery to 8 hours following surgery|Only patients actually taking rescue medication are included in analysis.|||Hours||Standard Deviation|Mean
2781555|NCT00659490|Secondary|Pain at Jaw Movement at Time of First Rescue Medication|"Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.~Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication (before 8 hours after end on surgery)|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781556|NCT00659490|Secondary|Pain at Rescue Medication|"Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.~Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication taken before 8 hours after end of surgery|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.|||mm||Standard Deviation|Mean
2781557|NCT00659490|Secondary|Mean Pain at Jaw Movement|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ).|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
2781558|NCT00659490|Secondary|Maximum Pain at Jaw Movement|"Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
2781559|NCT00659490|Secondary|Pain at Jaw Movement AUC0-4h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable).|0-4h after end of surgery to 4 hours post surgery|The analyses based on a per-protocol pop.|||mm*h||Standard Deviation|Mean
2781560|NCT00659490|Secondary|Pain at Jaw Movement AUC0-8h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable)|0-8h from end of surgery to 8 hours post surgery|The analyses based on a per-protocol pop.|||mm*h||Standard Deviation|Mean
2781561|NCT00659490|Secondary|Mean Pain Based on a VAS Scale|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
2781562|NCT00659490|Secondary|Maximum Pain Based on VAS Scale|"Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.|||mm||Standard Deviation|Mean
2781563|NCT00659490|Secondary|Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-4h (from end of surgery to 4 hours post surgery)|The analyses based on a per-protocol population.|||mm*h||Standard Deviation|Mean
2781564|NCT00659490|Primary|Pain Area Under the Curve 0-8h (AUC0-8h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-8 h(from end of surgery to 8 hours post surgery)|The analyses based on a per-protocol population.|||mm*h||Standard Deviation|Mean
2781565|NCT00659438|Secondary|Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs|"To investigate the relationship between response to vandetanib, CTCs and CECs. To investigate gene signature profile of antiangiogenic response by gene micro-array analysis of CTCs.~Gene signature profile of CTCs was aimed to be compared before and after 2 months of treatment. No blood sample has been taken for the study, and so results on CTCs, CECs of tumour vessels and gene and signature profiles of CTCs were not performed."|4 months|||||||
2781566|NCT00659438|Secondary|Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CEC. Numbering of CECs was to be performed at baseline, 1 week, 1 month and 2 months after randomisation.~Correlation between the number of CECs and PSA response was to be estimated after 1 week, 1 month and 2 months of treatment."|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.||||||
2781567|NCT00659438|Secondary|Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CTC. Numbering of CTCs to be performed at baseline, 1 week, 1 and 2 months after randomisation. This study was proposed only to patients followed in a study centre located in Ile de France.~Correlation between the number of CTCs and PSA response was to be estimated after 1 week, 1 and 2 months of treatment"|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.||||||
2781568|NCT00659438|Secondary|Progression Rate From the Radionuclide Bone Scanning|To describe the effect of vandetanib on progression rate from the radionuclide bone scanning in a sub-group of patients who had a bone scan within 3 to 6 months after 1st treatment dose. Number of participants with at least 2 new lesions on the radionuclide bone scan compared to baseline assessment were counted for calculation of progression rate.|4 months||||Participants|||Number
2781569|NCT00659438|Secondary|Overall Survival (OS)|To investigate the effect of vandetanib on overall survival. Patients alive at the time of the statistical analysis were censored at the time they were last known to be alive. Due to censored data, median overall survival in the placebo group cannot be calculated. OS defined as the number of participants who were alive.|End of study (July 2011)||||participants|||Number
2781570|NCT00659438|Secondary|PSA Response Rate|"To investigate the effect of vandetanib on the PSA response rate. PSA response rate defined by the number of participants with a PSA decrease relative to baseline of at least 50%.~A minimum decrease of 2 ng/mL in absolute value and a confirmation on at least 2 consecutive occasions (at least 4 weeks apart) were requested."|4 months||||Participants|||Number
2781571|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to onset of cancer-related symptoms was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months||||weeks||95% Confidence Interval|Median
2781572|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to PSA progression was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months||||weeks||95% Confidence Interval|Median
2781573|NCT00659438|Primary|Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months|"To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set).~PSA progression free rate defined as the number of participants with :~After decline from baseline: a 25% increase above the nadir~No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)"|4 months||||Participants|||Number
2781574|NCT00659425|Secondary|Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)|Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||participants|||Number
2781575|NCT00659425|Secondary|CD22 Expression Cells in Peripheral Blood by Best Response|Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively|||sites per cell||Full Range|Median
2781621|NCT00659061|Primary|Mean Hemoglobin of Participants Post Intervention||Endline Hb taken 4-5 months post enrollment||||g/dL||95% Confidence Interval|Mean
2781622|NCT00659061|Primary|Number of Participants With Moderate to Severe Anemia|number of participants with moderate - severe anemia defined as Hb < 10g/dL|Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment||||participants|||Number
2781576|NCT00659425|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody|Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
2781577|NCT00659425|Primary|Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||hour (h)||Standard Deviation|Mean
2781578|NCT00659425|Primary|Systemic Clearance (CL) for Moxetumomab Pasudotox|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]).|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||milliliter per hour per kilogram||Standard Deviation|Mean
2781579|NCT00659425|Primary|Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox|The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||hour*nanogram per milliliter (h.ng/mL)||Standard Deviation|Mean
2781580|NCT00659425|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6|Evaluable Population for efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2781581|NCT00659425|Primary|Overall Survival (OS)|Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
2781582|NCT00659425|Primary|Progression-Free Survival (PFS)|Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
2781583|NCT00659425|Primary|Time to Disease Progression (TDP)|Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
2781584|NCT00659425|Primary|Duration of Response (DR)|Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment|Evaluable Population for Efficacy. Here, “N” is number of participants with objective disease response in the respective cohort. DR could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).|||months||Full Range|Median
2781585|NCT00659425|Primary|Time to Disease Response|Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Evaluable Population for Efficacy. Here, “N” is number of participants with objective disease response in the respective cohort. Time to disease response could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).|||months||Full Range|Median
2781586|NCT00659425|Primary|Percentage of Participants With Relapse of Disease|Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|Efficacy population. Here, “N” is number of participants with CR in the respective cohort. Rate of relapse could not be estimated as none of the participants experienced CR in the 5 mcg/kg, 20 mcg/kg (Schema A) and 30 mcg/kg (schema A) cohort of the study.|||percentage of participants|||Number
2781623|NCT00659061|Secondary|Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention||Measurement taken 4-5 months post enrollment||||ug/dl||95% Confidence Interval|Mean
2781587|NCT00659425|Primary|Objective Response Rate (ORR)|Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)].|Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)|"Efficacy population included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. Here, N is number of participants analyzed for this outcome measure."|||percentage of participants|||Number
2781588|NCT00659425|Primary|Best Overall Tumor Response|Antitumor activity was assessed by best overall tumor response.|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|"Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, N is number of participants analyzed for this outcome measure."|||Participants|||Number
2781589|NCT00659425|Primary|Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate|The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.|Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||milli seconds (msec)||Standard Deviation|Mean
2781590|NCT00659425|Primary|Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG|Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist|Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||participants|||Number
2781591|NCT00659425|Primary|Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline|Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.|Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
2781592|NCT00659425|Primary|Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants|An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.|From start of study drug administration up to 30 days after the last dose of study drug|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
2781593|NCT00659425|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.|From start of study drug administration up to 30 days after the last dose of study drug|Safety population included all participants who received any treatment of study drug.|||Participants|||Number
2781594|NCT00659425|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.|From start of study drug administration until 30 days after the last dose of study drug|Safety Population included all participants who received any treatment of study drug.|||Participants|||Number
2781595|NCT00659425|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until 30 days after the last dose of study drug|Safety Population included all participants who received any treatment of study drug.|||Participants|||Number
2781596|NCT00659425|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.|Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)|"Evaluable Population for DLT included all participants who received any treatment of moxetumomab pasudotox (CAT-8015) and completed the DLT period without a DLT, or did not complete the DLT period due to a DLT. Here, N is number of participants evaluated for this outcome measure."|||participants|||Number
2781624|NCT00659061|Secondary|Vitamin A Status of Participants - Post Intervention|Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl|Measurement taken 4-5 months post enrollment|those who had endline assessment of serum vitamin A|||participants|||Number
2781625|NCT00659061|Primary|Number of Participants With Anemia|number with mild to severe anemia (hemoglobin(Hb)<11g/dL)|Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment||||participants|||Number
2781597|NCT00659373|Primary|Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)|Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.|1 year after patient randomization to parent IBCSG 24-02 study||||standardized units||Standard Deviation|Mean
2781598|NCT00659360|Secondary|Time to Disease Progression|"The Kaplan-Meier method will be used to estimate time to progression estimates.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 5 years||||months||95% Confidence Interval|Median
2781599|NCT00659360|Secondary|Duration of Response|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;~Objective Tumor Response of more than 4 months was counted toward the Disease Control Rate."|Up to 5 years|Patients who had partial response, complete response or stable disease|||participants|||Number
2781600|NCT00659360|Secondary|Stable Disease Rate|Achieved stable disease as their best response|Up to 5 years||||participants|||Number
2781601|NCT00659360|Secondary|Overall Survival|Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.|Up to 5 years||||months||95% Confidence Interval|Median
2781602|NCT00659360|Secondary|Objective Response Rate|Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 5 years||||participants|||Number
2781603|NCT00659360|Primary|Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.|Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|Up to 5 years||||participants|||Number
2781604|NCT00659334|Secondary|Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.||2 years|||||||
2781605|NCT00659334|Secondary|Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.||2 years|||||||
2781606|NCT00659334|Secondary|Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue||2 years|||||||
2781607|NCT00659334|Primary|Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.|Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.|24 hours (some patients between 3 and 72 hours) after administration of Combidex||||Participants|||Number
2781608|NCT00659295|Primary|Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events|The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.|Months 0-12|FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once|||participants|||Number
2781609|NCT00659269|Primary|Change in Neurotoxicity Assessment Between Cycle 4 and Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.|4 weeks|Of the 92 & 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 & 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 & 20 patients in Group 2 (Heavy Metals) and 5 & 9 patients in Group 3 (Vinca)|||units on a scale||Standard Deviation|Mean
2781626|NCT00658996|Primary|Contact Lens High Contrast Visual Acuity|VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.|Over-all follow-up visits, 2 weeks|All eligible, dispensed eyes|||LogMAR|Participants|Standard Deviation|Mean
2783380|NCT00641147|Secondary|Change in Micro RNA 124-U6 (miR124-U6)|Change in MicroRNA mean activity level at 8 months compared to baseline (time 0)|Baseline and 8 months||||qRT-PCR relative to U6 snRNA||Standard Deviation|Mean
2781610|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 4|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.|4 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 & 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 & 21 patients in Group 2 (Heavy Metals) and 6 & 9 patients in Group 3 (Vinca)|||units on a scale||Standard Deviation|Mean
2781611|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 2|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.|2 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 & 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 & 25 patients in Group 2 (Heavy Metals) and 9 & 10 patients in Group 3 (Vinca)|||units on a scale||Standard Deviation|Mean
2781612|NCT00659269|Primary|Neurotoxicity Assessment at Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.|At study start; prior to treatment (week 0)|Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)|||units on a scale||Standard Deviation|Mean
2781613|NCT00659230|Secondary|Clinician Administered PTSD Scale Subscale C Score|The Clinician Administered PTSD Subscale C (CAPS-C) measures the Avoidance and emotional numbing cluster of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS-C is zero to 56. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2, 4, and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
2781614|NCT00659230|Secondary|Clinician Administered PTSD Scale Subscale B Score|The Clinician Administered PTSD Subscale B (CAPS-B) measures the re-experiencing cluster of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS-B is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78). Blake, D.D., Weathers, F.W., Nagy, L.M., Kaloupek, D.G., Gusman, F.D., Charney, D.S., Kean, T.M., 1995, The development of a clinician-administered PTSD scale. Journal of Traumatic Stress, 8:75-90.|6 weeks|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
2781615|NCT00659230|Secondary|Clinician Administered PTSD Scale Total Score|The Clinician Administered PTSD Scale (CAPS) measures the full spectrum of PTSD symptoms. Higher scores indicate greater severity. Range for CAPS is zero to 136. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2,4, and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
2781616|NCT00659230|Primary|Clinician Administered PTSD Scale Subscore D (Hyperarousal)|The Clinician Administered PTSD Scale subscore D (CAPS-D) measures the hyperarousal cluster for PTSD symptoms (5 items). Higher scores indicate greater severity. Range for CAPS-D is zero to 40. The CAPS has acceptable test-retest reliability (0.98), sensitivity (0.84), specificity (0.95), internal consistency (0.76-0.88) and validity (κ=0.78).|Baseline, week 2, 4 and 6|Participants who returned for at least one post-randomization visit and had source documentation (in placebo group 2 did not return and the source documentation for 5 participants was lost; for nepicastat group 3 did not return and the source documentation for 4 participants was lost).|||units on a scale||Standard Deviation|Mean
2781617|NCT00659165|Primary|Calories Consumed After Fast.|Total energy ingested following the 24 hour fast.|Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks||||kcal||Standard Deviation|Mean
2781618|NCT00659061|Secondary|Percentage of Participants With Wasted Growth|Wasted defined as Weight for Height Z-score < -2SD|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete anthropometric measurements at endline|||percentage of participants|||Number
2781619|NCT00659061|Secondary|Percentage of Participants With Stunted Growth|Stunted defined as Height for Age Z-score < -2 standard deviation|Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment|Those who had complete anthropometric measurements at endline|||percentage of participants|||Number
2781620|NCT00659061|Secondary|Percentage of Underweight Participants|Underweight defined as Weight for Age Z score < -2 standard deviation (SD)|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete baseline anthropometric measures|||percentage of participants|||Number
2781627|NCT00658996|Secondary|Slit Lamp Findings|Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates|Over-all follow-up visits, 2 weeks|All dispensed eyes, over all follow-up visits|||Eyes|Participants||Number
2781628|NCT00658996|Primary|Symptoms and Complaints|1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.|Over-all follow-up visits for 2 week period|All eligible, dispensed eyes, Overall follow-up visits.|||Scores on a Scale|Participants|Standard Deviation|Mean
2781629|NCT00658879|Primary|Clinical Effectiveness Rate in Participants With Diabetes Mellitus (Concurrent Disease)|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as effective, ineffective or unassessable by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by diabetes mellitus (concurrent disease) were counted to assess whether it contributes to the clinical effectiveness."|5 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as “unassessable” were excluded from the calculation.|||Percentage of Participants|||Number
2781630|NCT00658879|Primary|Clinical Effectiveness Rate in Participants With Hepatic Function Disorder|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as effective, ineffective or unassessable by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by hepatic function disorder were counted to assess whether it contributes to the clinical effectiveness."|5 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as “unassessable” were excluded from the calculation.|||Percentage of Participants|||Number
2781631|NCT00658879|Primary|Clinical Effectiveness Rate by Age|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as effective, ineffective or unassessable by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness."|5 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as “unassessable” were excluded from the calculation.|||Percentage of Participants|||Number
2781632|NCT00658879|Primary|Clinical Effectiveness Rate by Gender|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as effective, ineffective or unassessable by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness."|5 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as “unassessable” were excluded from the calculation.|||Percentage of Participants|||Number
2781633|NCT00658879|Primary|Clinical Effectiveness Rate|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Somavert was assessed as effective, ineffective or unassessable by the physician. Overall effectiveness of Somavert was determined by the physician based on clinical symptoms, laboratory values, and other examinations such as ring size."|5 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as “unassessable” were excluded from the calculation.|||Percentage of Participants|||Number
2781634|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events for Participants With Diabetes Mellitus (Concurrent Disease)|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by diabetes mellitus (concurrent disease) to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781635|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events for Participants With Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by renal impairment to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781741|NCT00658359|Secondary|Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit|Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||g/dL||Standard Deviation|Mean
2781636|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events for Participants With Hepatic Function Disorder|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by hepatic function disorder to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781637|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events by Age|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781638|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events by Gender|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Relatedness to Somavert was assessed by the physician. Participants with treatment-related adverse events were counted by gender to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781639|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Somavert was assessed by the physician.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781640|NCT00658879|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Somavert in a participant who received Somavert. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Somavert was assessed by the physician.|5 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Somavert at least once.|||Participants|||Count of Participants
2781641|NCT00658814|Secondary|Relapse-free Survival|Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.|Up to 5 years||||months||95% Confidence Interval|Median
2781642|NCT00658814|Primary|30-Day Survival|Patients surviving more than 30 days after study registration|30 days||||percentage of participants||95% Confidence Interval|Number
2781643|NCT00658814|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.|Up to 60 days||||percentage of participants||95% Confidence Interval|Number
2781644|NCT00658814|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2781645|NCT00658788|Secondary|Tolerability Assessment - Folliculitis||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
2781646|NCT00658788|Secondary|Tolerability Assessment - Skin Atrophy||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
2781647|NCT00658788|Secondary|Tolerability Assessment - Stinging/ Burning||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
2781648|NCT00658788|Secondary|Tolerability Assessment - Telangiectasias||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
2781649|NCT00658788|Secondary|Tolerability Assessment - Pruritus||Baseline, 2, 4, 8 and 12 weeks||||participants|||Number
2781650|NCT00658788|Secondary|Overall Disease Severity||2, 4, 8 and 12 weeks||||participants|||Number
2781651|NCT00658788|Secondary|Percent Change From Baseline in Body Surface Area (% BSA) Affected||2, 4, 8 and 12 weeks||||Percent Change from Baseline||Standard Deviation|Mean
2781652|NCT00658788|Secondary|Signs of Psoriasis - Plaque Elevation||2, 4, 8 and 12 weeks||||participants|||Number
2781653|NCT00658788|Secondary|Signs of Psoriasis - Scaling||2, 4, 8 and 12 weeks||||participants|||Number
2781654|NCT00658788|Secondary|Signs of Psoriasis - Erythema||2, 4, 8 and 12 weeks||||participants|||Number
2781655|NCT00658788|Secondary|Global Improvement Score||2, 4, 8 and 12 weeks||||participants|||Number
2781656|NCT00658788|Primary|Overall Disease Severity Success (ODS)|Success was defined as a one-grade improvement in ODS from baseline.|8 and 12 weeks|The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.|||percentage of participants||95% Confidence Interval|Number
2781742|NCT00658359|Secondary|Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit|Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||k/mm^3||Standard Deviation|Mean
2781657|NCT00658775|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population|||Percentage of Participants|||Number
2781658|NCT00658775|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|ITT Population - all randomized subjects who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2781659|NCT00658775|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population|||Percentage of Participants|||Number
2781660|NCT00658736|Secondary|Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component|The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.|1 month||||units on a scale||Standard Deviation|Mean
2781661|NCT00658736|Primary|Change in Pain Disability Index|The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.|1 month after block||||Participants|||Count of Participants
2781662|NCT00658723|Secondary|Incidence of Adverse Events||30 days (+14 days)||||% if participants with atleast one AE|||Number
2781663|NCT00658723|Secondary|Incidence of Re-treatment|"The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.~In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment."|Intra-operative||||participants|||Number
2781664|NCT00658723|Secondary|Incidence of Adverse Events Potentially Related to Transfusion Exposure|The types of events that were potentially related to transfusion exposure could have include hypocalcemia.|Intra-operative up to 1 month (+14 days)||||percentage of particpants|||Number
2781665|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Thrombotic Events|The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism|Intra-operative up to 1 month (+14 days)||||percentage of participants|||Number
2781666|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Bleeding|The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).|Intra-operative up to 1 month (+14 days)||||percentage of particpants|||Number
2781667|NCT00658723|Secondary|Incidence of Treatment Failures|If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.|Intra-operative||||percentage of treatment failure|||Number
2781668|NCT00658723|Secondary|Proportion of Subjects Achieving Hemostatic Success|The proportion of subjects achieving hemostatic success at 10 minutes following randomization|10 minutes||||percentage of success|||Number
2781669|NCT00658723|Primary|Proportion of Subjects Achieving Hemostatic Success|Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.|Intra-operative||||percentage of success|||Number
2781670|NCT00658697|Secondary|Toxicity|Treatment related adverse events were graded based on CTCAE v. 3.0.|Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years|All patients received at least one study therapies|||participants|||Number
2781671|NCT00658697|Primary|Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)|"For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL.~For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA >2.0 ng/mL.~Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression."|participants were followed for the duration of the study, an average of 2 years||||percentage of participants with data||95% Confidence Interval|Number
2781672|NCT00658697|Secondary|Testosterone Recovery|Testosterone recovery was defined as >100 or within DFCI institute normal range (240-950) at one year after the completion of ADT|2 years|All treated patients with assessable testosterone level data|||percentage of participants with data||95% Confidence Interval|Number
2791331|NCT00583557|Primary|To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.|SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.|Up to 5 years||||Particpants|||Number
2781673|NCT00658697|Secondary|Time to PSA Progression (TTP)|For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA > 2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value|participants were followed for the duration of the study, an average of 2 years|the analysis dataset is comprised of all treated patients|||months||95% Confidence Interval|Median
2781674|NCT00658697|Secondary|Proportion of Patients With PSA Responses at One Year After the Completion of ADT|The PSA response was defined using two cut-offs: PSA <0.2 ng/mL or PSA <0.01 ng/mL at the one year after completion of ADT.|1 year + 3 month off last ADT injection|"The analysis comprised of all patients received at least one treatment and had PSA data available* for the assessment of PSA responses at one year after completing ADT~*Note excluded 5 patients started treatments but had no PSA information at one year."|||percentage of participants with data||95% Confidence Interval|Number
2781675|NCT00658684|Primary|Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume|The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|52 Weeks|The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.|||Number of subjects|||Number
2781676|NCT00658684|Secondary|Change From Baseline in Grade of PPBC at Week 28 and 52|"The PPBC assessment was rated on a 6-point scale as follows:~no problems at all~some very minor problems~some minor problems~some moderate problems~severe problems~many severe problems~Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement."|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)|||Scores on a scale||Standard Deviation|Mean
2781677|NCT00658684|Secondary|The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage|"The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:~no problems at all~some very minor problems~some minor problems~some moderate problems~severe problems~many severe problems"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)|||Number of subjects|||Number
2781678|NCT00658684|Secondary|Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52|"OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).~Change: mean at Week 28 and 52 minus mean at baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)|||Scores on a scale||Standard Deviation|Mean
2781679|NCT00658684|Secondary|Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52|"KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.~KHQ consists of the following domains:~General health perceptions (GHP)~Impact on life~Role limitations~Physical limitations~Social limitations~Personal relationships (PR)~Emotions~Sleep/energy~Incontinence severity measures (ISM)~Change: mean at Week 28 and 52 minus mean at Baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)|||Scores on a ascle||Standard Deviation|Mean
2781680|NCT00658684|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)|||mL||Standard Deviation|Mean
2781681|NCT00658684|Secondary|Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52|"The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)|||Number of micturitions||Standard Deviation|Mean
2781690|NCT00658658|Primary|Area Under the Concentration-time Curve During the Dosing Interval (AUC0-tau) for Panitumumab|The area under the serum concentration-time curve from time zero to the end of the dosing interval (AUCtau), estimated using the linear trapezoidal method.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||day*μg/mL||Standard Deviation|Mean
2781682|NCT00658684|Secondary|Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)|||Number of episodes||Standard Deviation|Mean
2781683|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)|||Number of episodes||Standard Deviation|Mean
2781684|NCT00658684|Secondary|Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52|"The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)|||Number of micturitions||Standard Deviation|Mean
2781685|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)|||Number of episodes||Standard Deviation|Mean
2781686|NCT00658658|Secondary|Percentage of Participants With Disease Control|"Disease assessments were based on investigator review of scans using modified RECIST version 1.0 criteria. A participant was considered to have disease control if their best response is either a complete or partial response, or stable disease. Participants without a post-baseline assessment were considered to not have disease control. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. A best overall response of SD requires a visit response of SD or better, no earlier than 49 days after the date of enrollment.~Stable disease (SD): Neither sufficient shrinkage of target lesions to qualify for a PR nor sufficient increase to qualify for PD and no progression of existing non-target lesions and no new lesions."|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease|||percentage of participants||95% Confidence Interval|Number
2781687|NCT00658658|Secondary|Percentage of Participants With an Objective Response|Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria. A participant was considered a responder if their best response was either a complete or partial response. Participants without a post-baseline assessment were considered non-responders. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response (CR): Disappearance of all target and non-target lesions, normalization of tumor markers and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions, no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) or/and maintenance of tumor marker level above normal limits, and no new lesions.|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease|||percentage of participants||95% Confidence Interval|Number
2781688|NCT00658658|Primary|Serum Clearance (CL) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||mL/day/kg||Standard Deviation|Mean
2781689|NCT00658658|Primary|Half-life (t1/2) for the Terminal Phase (First Dose) or Dosing Interval (Third Dose) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||days||Standard Deviation|Mean
2781691|NCT00658658|Primary|Minimum Observed Concentration (Cmin) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."|||μg/mL||Standard Deviation|Mean
2781692|NCT00658658|Primary|Maximum Observed Concentration (Cmax) of Panitumumab|Panitumumab serum concentration was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 400 pg/mL. Concentrations below the LLOQ were set to zero.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"Pharmacokinetic (PK) Analysis Set (all participants who received the correct dose of panitumumab and from whom the PK parameters could be assessed); n indicates the number of participants with available data for each time point."|||μg/mL||Standard Deviation|Mean
2781693|NCT00658658|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event is defined as an AE that: • is fatal; • is life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; • other significant medical hazard. The investigator assessed whether adverse events were related to panitumumab. The severity of adverse events was based on CTCAE version 3 (with the exception of skin- or nail-related toxicities which were graded using the CTCAE version 3.0 with modifications), according to the following: Grade 1 = Mild (aware of sign or symptom, but easily tolerated); Grade 2 = Moderate (discomfort enough to cause interference with usual activity); Grade 3 = Severe (incapacitating with inability to work or do usual activity); Grade 4 = Life-threatening or disabling; Grade 5 = Fatal.|From first dose date to end of study date. The median duration of study was 47 days.|Safety Analysis Set (all participants who received at least 1 dose of panitumumab)|||participants|||Number
2781694|NCT00658658|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Three validated assays were used to detect the presence of anti-panitumumab antibodies. Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. All samples confirmed to be positive by drug specificity in either screening immunoassay were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay. The number of participants who developed antibodies to panitumumab is the number of participants with a non-positive (including missing) antibody result at baseline and a positive antibody result at any post-baseline time point.|Before panitumumab administration on Day 1, Day 43, Day 169 and 30 days after last dose for all cohorts.|Safety Analysis Set participants with at least one post-baseline immunoassay result|||participants|||Number
2781695|NCT00658658|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhea, nausea, or vomiting that persisted for at least 5 days despite maximum supportive therapy; • Grade 4 skin or nail toxicity.|28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.|DLT Analysis Set (all participants who received at least 1 dose of panitumumab and were evaluated for DLTs and completed at least 28 days (for the 2.5 and 6 mg/kg cohorts) or 21 days (for 9 mg/kg cohort) of therapy unless due to a DLT)|||participants|||Number
2781696|NCT00658632|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.|||Percentage of Participants|||Number
2781697|NCT00658632|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.|||Percentage of Participants|||Number
2781698|NCT00658632|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.|||Percentage of Participants|||Number
2781781|NCT00657709|Secondary|Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)|The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.|1 month after third vaccination|Analysis was done on PP dataset.|||IU/mL||95% Confidence Interval|Geometric Mean
2781699|NCT00658619|Secondary|Change From Baseline in Reading Speed in the Study Eye|Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2|||Words per Minute (wpm)||Standard Deviation|Mean
2781700|NCT00658619|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2|||Number of Letters Read Correctly||Standard Deviation|Mean
2781701|NCT00658619|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2|||Number of Letters Read Correctly||Standard Deviation|Mean
2781702|NCT00658619|Secondary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).|Baseline, Month 3, Month 6, Month 9, Month 18, Month 24|Intent-to-Treat: All randomized patients who participated in Stage 2|||Disc Area||Standard Deviation|Mean
2781703|NCT00658619|Primary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).|Baseline, Month 12|Intent-to-Treat: All randomized patients who participated in Stage 2|||Disc Area||Standard Deviation|Mean
2781704|NCT00658606|Secondary|Change in Dermatology Life Quality Index (DLQI)|"The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst).~A negative change from Baseline represents improvement.~Change is calculated as Week 36- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."|||DLQI Score||Standard Deviation|Mean
2781705|NCT00658606|Secondary|Time for a 75% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~Only subjects who experienced 75% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who experienced a 75% decrease in PASI were included in the analysis."|||Days||Inter-Quartile Range|Mean
2781706|NCT00658606|Secondary|Time for 50% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~Only subjects who experienced 50% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who experienced a 50% decrease in PASI were included in the analysis."|||Days||Inter-Quartile Range|Median
2781707|NCT00658606|Secondary|Time to Relapse|"The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed.~Relapse is defined by a loss of 50% of improvement in PASI."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who achieved a 75% improvement in PASI and then relapsed were included in the analysis."|||Days||Standard Deviation|Mean
2781708|NCT00658606|Secondary|Percentage of Subjects Who Achieve PASI 90 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
2781740|NCT00658359|Secondary|Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Months 24, 36, 48, 60, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Percentage||Standard Deviation|Mean
2781794|NCT00657605|Primary|Change in Weight||Baseline, 107 months||||lbs|||Number
2781709|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.~Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
2781710|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.~Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
2781711|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study|"A negative change from Baseline represents improvement.~Change is calculated as Week 36- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."|||Percentage of BSA||Standard Deviation|Mean
2781712|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16|"A negative change from Baseline represents improvement.~Change is calculated as Week 16- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 16|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."|||Percentage of BSA||Standard Deviation|Mean
2781713|NCT00658606|Secondary|Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who completed follow-up were included in this analysis."|||Percentage of Subjects|||Number
2781714|NCT00658606|Primary|Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).|||Percentage of Subjects|||Number
2781715|NCT00658567|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total possible score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: ANCOVA, and missing data was imputed using LOCF method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.|||Score on UPDRS-II+III scale.||95% Confidence Interval|Least Squares Mean
2781716|NCT00658567|Primary|Antipsychotic Efficacy|"Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.|||Scores on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
2781717|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.|||ng-hr/mL||Standard Deviation|Mean
2783296|NCT00642304|Secondary|Percentage of Participants With Dose Adjustment|A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.|Baseline up to Week 20|ITT population|||Percentage of participants|||Number
2781718|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.|||ng-hr/mL||Standard Deviation|Mean
2781719|NCT00658541|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.|||ng/mL||Standard Deviation|Mean
2781720|NCT00658528|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population|||Percentage of Participants|||Number
2781721|NCT00658528|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2781722|NCT00658528|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population|||Percentage of Participants|||Number
2781723|NCT00658515|Secondary|Adverse Events, Lab Parameters, Vital Signs, ECG||Throughout Study, up to 53 Months|Data not collected||||||
2781724|NCT00658515|Secondary|Change From Baseline for HDL Cholesterol||At 53 Months||||mg/dL||Standard Error|Least Squares Mean
2781725|NCT00658515|Secondary|Composite Endpoint:All Cause Mortality||Throughout Study, up to 53 Months||||Participants|||Count of Participants
2781726|NCT00658515|Primary|Incidence of Cardiovascular Mortality and Morbidity|Number of cardiovascular events per patient per year|From date of randomization to first event up to 48 months||||Event per Patient Years of Followup|||Number
2781727|NCT00658411|Secondary|1-year Post-Transplant Survival|Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.|1 year|Stopped early for poor accrual|||participants|||Number
2781728|NCT00658411|Primary|Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.|"All patients meeting the criteria for Severe iron overload as defined by BOTH:~ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy."|Baseline , 6 month, 1 year|Patients who met criteria for iron overload pre-transplant, as defined by the protocol, were enrolled on study for chelation therapy. Those patients who received therapy were monitored for toxicities using the CTCAE version 3.0.|||Participants|||Number
2781729|NCT00658385|Primary|Number of Participants With no Serious Adverse Events|The entered value represents the number of participants with the absence of serious adverse events. G-CSF mobilization will be considered safe if there are no more than 1 of 5 patients with SAEs|Up to 14 Days||||participants|||Number
2781730|NCT00658359|Secondary|Mean Trough Levels of Cyclosporine by Visit|All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose).|Predose: Months 18, 24, 36, 48, 60, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||ng/mL||Standard Deviation|Mean
2781731|NCT00658359|Secondary|Mean Trough Levels of Tofacitinib by Visit|The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points >1 hour post dose were required within 30 minutes of the nominal time point.|Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours)|Safety Analysis Set. n is the number of participants with the assessment at each time point.|||ng/mL||Standard Deviation|Mean
2783297|NCT00642304|Secondary|Percentage of Participants With Blood Transfusion||Baseline up to Week 28|ITT population|||Percentage of participants|||Number
2781732|NCT00658359|Secondary|Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36|"SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction).~Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used."|Months 24, 36|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Score||Standard Error|Least Squares Mean
2781733|NCT00658359|Secondary|Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36|"ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants' rated the question At the moment,how much do you suffer? for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction.~Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used."|Months 24, 36|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Score on a scale||Standard Error|Least Squares Mean
2781734|NCT00658359|Secondary|Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36|SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 [minimum] to 5 [maximum]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used.|Months 24, 36|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Score on a scale||Standard Error|Least Squares Mean
2781735|NCT00658359|Secondary|Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit|"GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m^2) by MDRD equation = 170 * (serum creatinine [mg/dL])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration [mg/dL])^(-0.170) * (serum albumin concentration [g/dL])^(0.318). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.~Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used."|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2781736|NCT00658359|Secondary|Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit|"GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.~Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used."|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||min/mL||Standard Error|Least Squares Mean
2781737|NCT00658359|Secondary|Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit|"GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Nankivell formula, where:~Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre [mmol/L]) - serum urea (mmol/dL)/2 + actual body weight (kilograms [kg])/4 - 100/Height (metres [m])^2 + (35 for male or 25 for female).~A normal GFR for adults is > 90 mL/min. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.~Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used."|Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||minutes per milliliter (min/mL)||Standard Error|Least Squares Mean
2781738|NCT00658359|Secondary|Percentage of Participants by Proteinuria Category by Visit|Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.|Months 24, 36, 48, 60, 72 and Follow-up|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||Percentage of Participants|||Number
2781739|NCT00658359|Secondary|Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Population. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
2781743|NCT00658359|Secondary|Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Population. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
2781744|NCT00658359|Secondary|Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
2781745|NCT00658359|Secondary|Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
2781746|NCT00658359|Secondary|Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit|Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.|Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants with the assessment at each visit.|||mg/dL||Standard Error|Least Squares Mean
2781747|NCT00658359|Secondary|Percentage of Participants Discontinuing From the Study|Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4.|Months 12 through 72.|Safety Analysis Set|||Percentage of Participants|||Number
2781748|NCT00658359|Secondary|Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit|The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
2781749|NCT00658359|Secondary|Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit|Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of participants||60% Confidence Interval|Number
2781750|NCT00658359|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit|Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection was calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
2781751|NCT00658359|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit|Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
2781752|NCT00658359|Primary|Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit|Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
2781753|NCT00658359|Primary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit|BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|FAS. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
2781754|NCT00658359|Primary|Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36|Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]). The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions.|Month 36|FAS. Only participants with Banff CS values at both Day 0 and Month 36 visits were included.|||Percentage of Participants|||Number
2781755|NCT00658359|Primary|Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])|Glomerular filtration rate (GFR): an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres [mL] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.|Month 36|Full analysis set (FAS, which was defined the same as the Safety Analysis Set). The analysis included 1 participant in CsA and 2 in Tofacitinib LI from before protocol Amendment 1. Only subjects at Month 36 with GFR calculations were included.|||mL/min||Standard Error|Least Squares Mean
2781756|NCT00658359|Primary|Percentage of Participants With Malignancies|All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page.|Months 12 through 72.|Safety Analysis Set. Percentages use n (the number of participants with malignancies: 7,8,8 respectively) and include 1 participant in CsA and 2 in Tofacitinib LI from before dose reduction to 5 mg by Month 18 was implemented (protocol Amendment 1)|||Percentage of Participants|||Number
2781757|NCT00658359|Primary|Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit|Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.|Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72|Safety Analysis Set. n is the number of participants remaining at risk at each visit.|||Percentage of Participants||60% Confidence Interval|Number
2781758|NCT00658333|Secondary|Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals|The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).|Baseline and week 4 to week 6|Safety Population|||mg||Standard Deviation|Mean
2781759|NCT00658333|Primary|Number of Participants With Response (Yes/no)|The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.|6 weeks|Intent to Treat Population|||Participants|||Number
2781760|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:~GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1"|Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.|||mL/min/1.73m^2||Full Range|Median
2781761|NCT00658320|Secondary|Extension Study: Cyclosporine Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) cyclosporine levels and was analyzed at a central laboratory using immunoassay.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.|||ng/mL||Standard Deviation|Mean
2781762|NCT00658320|Secondary|Extension Study: Everolimus Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) everolimus levels and was analyzed at a central laboratory using liquid chromatography mass spectrometry.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.|||ng/mL||Standard Deviation|Mean
2781763|NCT00658320|Secondary|Extension Study: Number of Participants With Adverse Events and Serious Adverse Events|Additional information about Adverse Events can be found in the Adverse Event Section.|24 Months|Participants from the Extension Safety Population.|||Participants|||Number
2781764|NCT00658320|Secondary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula|"The Nankivell formula was used to calculate GFR at Month 24:~GFR[mL/min]=6.7/C + W/4 - UREA/2 - 100/H^2 + 35 (25 for females) W= body weight [kg] H= height [m] C= serum creatinine [mmol/L] UREA= serum urea [mmol\L]"|Month 24, Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.|||mL/min||Standard Deviation|Mean
2781765|NCT00658320|Secondary|Extension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)|"Graft loss was defined as the day the patient started dialysis and was not able to subsequently be removed from dialysis or re-transplant.~Loss-to-follow was a patient who did not experience a treated BPAR, graft loss or death and whose last day of contact was prior to Month 24.~A Graft Biopsy was done within 48 hours of suspect rejection. Biopsies were read by the local pathologist according to the updated Banff '97 criteria.~Treated BPAR was based on local laboratory biopsy results and was defined as a biopsy Banff criteria graded IA to III that was treated with anti-rejection therapy."|24 Months|Extension Intent-to-treat population.|||Participants|||Number
2781766|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:~GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1~Loss to follow up (in In Primary Core Outcome Measure) is composite efficacy failure and contains incidence of treated BPAR, graft loss, death or loss to follow-up"|Month 24|Participants from the Extension Intent-to-treat population with data available for analyses.|||mL/min/1.73m^2||Full Range|Median
2781767|NCT00658320|Secondary|Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:~Calculated GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|Month 12||||mL/min/1.73m^2||Full Range|Median
2781768|NCT00658320|Secondary|Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up|"The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.~A loss to follow-up in graft loss, death or loss to follow-up is a patient who did not experience graft loss or death and whose last day of contact was prior to Day 316, i.e. prior to the Month 12 visit window."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.|||Participants|||Number
2781769|NCT00658320|Primary|Core Study: Number of Patients With Composite Efficacy Endpoint|"The composite efficacy endpoint consisted of treated biopsy proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.~For the individual components (including loss of follow-up)of the composite endpoint, patients are counted for the first event to occur."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.|||Participants|||Number
2781770|NCT00658138|Primary|Percentage of Restorations Scoring Alpha|Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.|12 months|Analysis was based on the number of study teeth available for review at 12 months|||percentage of Alpha scores|Participants||Number
2781771|NCT00658112|Primary|Adherence|Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied|6 weeks||||percentage of doses actually applied||Full Range|Mean
2781772|NCT00657917|Secondary|Safety and Tolerability (SAE's and AE's)|Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's|180 days|Ultimately, the planned statistical analysis could not be performed because only one patient was enrolled in the study.|||Number of AE's|||Number
2781773|NCT00657917|Secondary|Number of Relapses|Evaluate the number of relapses occurring by day 180|180 days|Ultimately, the planned statistical analysis could not be performed because only one patient was enrolled in the study.|||Number of relapses|||Number
2781774|NCT00657917|Primary|The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse|Appearance of complete (100%) epithelialization of a skin lesion at day 50+2 weeks, or the estimated 50%-99% re-epithelialization by day 50+2 weeks followed by complete eipithelialization by day 100+2 weeks, with both categories without relapse by day 180+30 days. Ulcer measured in millimeters.|180 days|Ultimately, the planned statistical analysis could not be performed because only one patient was enrolled in the study.|||Surface area in millimeters squared|||Number
2781775|NCT00657709|Secondary|Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine|The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.|upto 7 days after any vaccination|The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data.|||Participants|||Number
2781776|NCT00657709|Secondary|Percentage of Subjects With hSBA Titers ≥1:8|Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.|1 month after third vaccination|Analysis was done on PP population|||Percentages of subjects||95% Confidence Interval|Number
2781777|NCT00657709|Secondary|Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.|1 Month after third vaccination|Analysis was done on PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
2781778|NCT00657709|Secondary|Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens|Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).|5 months|Analysis was done on PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
2781779|NCT00657709|Secondary|Percentages of Subjects With Antibody Response Against the Routine Antigens|"The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.~HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml"|1 Month after third vaccination|Analysis was done on PP population.|||Percentages Of Subjects||95% Confidence Interval|Number
2781780|NCT00657709|Secondary|Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations|Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.|1 month after third vaccination|Analysis was done on Immunogenicity Routine PP (Pertussis Antigens)|||IU/mL||95% Confidence Interval|Geometric Mean
2781782|NCT00657709|Secondary|Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ|The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.|1 Month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2781783|NCT00657709|Secondary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)|The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.|1 month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2781784|NCT00657709|Primary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)|The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.|one month after the third vaccination|Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2781785|NCT00657709|Primary|The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination|The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2781786|NCT00657657|Secondary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine||||subjects|||Number
2781787|NCT00657657|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine||||subjects|||Number
2781788|NCT00657657|Secondary|Concentration of Anti-HBs Antibodies|Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose.|One month after the hepatitis B vaccine challenge dose||||mIU/mL||95% Confidence Interval|Geometric Mean
2781789|NCT00657657|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose||||subjects|||Number
2781790|NCT00657657|Primary|Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine|"Immune response to a challenge dose of hepatitis B vaccine is defined as~at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or~a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (<3.3 mIU/mL) at the previous available long-term time point."|One month after the hepatitis B vaccine challenge dose||||subjects|||Number
2781791|NCT00657618|Primary|Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events|The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required.|prior to infusion on days 2) 5, 10, 15, 20, 25, and 28|74 patients received at least one dose of IV pentostam|||Participants|||Count of Participants
2781792|NCT00657618|Primary|Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience|The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required.|prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28|74 patients received at least one dose of IV pentostam|||Participants|||Count of Participants
2781793|NCT00657605|Secondary|Change in Glucose Levels||Baseline, 107 months||||mg/dL|||Number
2781795|NCT00657553|Primary|Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2|"The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates.~Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication."|three years|||||||
2781796|NCT00657540|Secondary|Drug-related Serious Adverse Events|The number of subjects with drug-related serious adverse events.|Start of Dose 1 through 17 days post treatment||||Participants|||Count of Participants
2781797|NCT00657540|Secondary|Number of Participants With at Least 13 mm Reduction in Pain Score at Any Time Point|The number of patients with a clinically significant decrease in pain intensity relative to baseline at any time point during the treatment phase was measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain was defined as a decrease in VAS scores of greater than or equal to 13 mm. The VAS ranged from 0 (no pain) to 100 mm (worst possible pain).|Start of Dose 1 to any post-infusion time point||||Participants|||Count of Participants
2781798|NCT00657540|Secondary|Drug-related Adverse Events|To evaluate safety of Analatro, the number of subjects experiencing at least one adverse event (AE) that was determined to be related to study drug was computed for each treatment group. All AEs classified as definitely or possibly related to study drug were considered drug-related.|Start of Dose 1 through 17 days post treatment||||Participants|||Count of Participants
2781799|NCT00657540|Secondary|Number of Participants With at Least 13 mm Reduction in Pain Score at 30 Minutes Post-Treatment|The number of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment (after Dose 1 and Dose 2, as applicable) will be measured by the patient's self-assessment of pain intensity using the visual analog scale (VAS). A clinically significant reduction in pain is defined as a decrease in VAS scores of greater than or equal to 13 mm. The VAS ranged from 0 (no pain) to 100 mm (worst possible pain).|30 minutes post treatment||||Participants|||Count of Participants
2781800|NCT00657540|Primary|Number of Participants With Treatment Failure|"The primary efficacy endpoint for this study was the number of subjects in which pain control was not achieved 48 hours post-study drug infusion as identified by treatment failure. A treatment failure was defined as a subject who did not achieve pain control during the treatment phase, up to 48 hours after Dose 1 infusion start time. Subjects were deemed treatment failures if they met one or more of the following criteria:~Subject did not complete the treatment phase due to absence of clinically significant improvement in pain intensity relative to baseline at 60, 90, 120, or 150 minutes post start of Dose 1.~Subject required treatment with commercially available antivenin or prescription pain medication for signs and symptoms associated with latrodectism at any time during the treatment phase up to 48 hours after Dose 1 infusion start time."|From start of Dose 1 infusion to 48 hours post treatment|The analysis population consists of all subjects that were randomized and received any study drug (modified intent to treat population).|||Participants|||Count of Participants
2781801|NCT00657371|Primary|Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.|Those polyps reported for Third Eye Retroscope were additional, located behind folds and then found with the colonscope only because they were first detected with the Third Eye Retroscope.|||polyps|Participants||Number
2781802|NCT00657371|Secondary|Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.|Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.|2 year study period to collect colonoscopy exam results|||||||
2781803|NCT00657371|Primary|Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.||||percent of polyps|Participants||Number
2781804|NCT00657358|Primary|Tactile Sensation|Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel. The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 mg). A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle. The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits. This assessment was to evaluate whether participants were able to feel the touch of the needle. The participant's arm was placed on a tray table. A linen sheet was suspended in-between two IV poles in such a fashion that the subject's view of his/her hand was blocked. Normal values are between 0.21mg and 5mg.|baseline, during 20 minute infusion, and 30 minutes after completion of infusion||||weight in mg||Standard Error|Mean
2781805|NCT00657358|Primary|Cold Pain|The participant's foot was immersed up to the ankle into a container filled with ice water of 3°C. Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance). The length of time was recorded in seconds. This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests. The range was 0 seconds to 120 seconds|baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion||||time in seconds to withdrawal||Standard Error|Mean
2781806|NCT00657358|Primary|Heat Pain|The thermal procedure involved a baseline assessment of heat pain threshold and tolerance. Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator. Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s. The 3 × 3 cm contact probe was applied to the right forearm. The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable|baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion||||units on a scale||Standard Error|Mean
2781807|NCT00657358|Primary|Electrical Pain|Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England). Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments. Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo). For each measure, the average of three trials was computed for use in subsequent analyses. Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design. The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable|Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion||||units on a scale||Standard Error|Mean
2781808|NCT00657358|Primary|Ischemic Pain|The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant's mean arterial pressure. Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength. Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.|baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion|health volunteers|||units on a scale||Standard Error|Mean
2781809|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|4 years|||||||
2781810|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy||2010-2012|||||||
2781811|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|2008-2012|||||||
2781812|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. Baseline glucose uptake scans will be compared with the scans on sitagliptin thirty days after baseline|30 days|Scans were lost in 4 participants|||SUV||Full Range|Mean
2781813|NCT00657267|Secondary|Time to Progression.|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.|||days||95% Confidence Interval|Median
2781814|NCT00657267|Secondary|Radiographic Response|Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) >/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response </= max dose w/in the first 8 weeks of therapy.|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.|||percentage of participants evaluated|||Number
2781815|NCT00657267|Secondary|Overall Survival||From patient registration until end of study, assessed up to 54 months|Entire study population|||months||95% Confidence Interval|Median
2781816|NCT00657267|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|Patients evaluable for imaging analysis, as protocol-defined.|||percentage of evaluable participants|||Number
2781817|NCT00657150|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients|||participants|||Number
2781818|NCT00657150|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|Treated and operated patients|||mL||Standard Deviation|Mean
2781819|NCT00657150|Secondary|Blood Transfusion|Number of treated and operated patients with required blood transfusion on day of surgery.|Day 1|Treated and operated patients|||participants|||Number
2781868|NCT00656799|Secondary|Vital Sign: Mean Heart Rate|Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex|||Beats per minute||Standard Deviation|Mean
2781820|NCT00657150|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|28-35 days|All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.|||Participants|||Number
2781821|NCT00657150|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up|||Participants|||Number
2781822|NCT00657150|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)|||Participants|||Number
2781823|NCT00657150|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)|||Participants|||Number
2781824|NCT00657150|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)|||Participants|||Number
2781825|NCT00657150|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)|||Participants|||Number
2781826|NCT00657150|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)|||Participants|||Number
2781827|NCT00657150|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)|||Participants|||Number
2781828|NCT00657150|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|28-35 days|Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)|||Participants|||Number
2781829|NCT00657046|Post-Hoc|Number Patients With Hypotension Induced Early Termination of Dialysis Procedure||6 weeks|Patients had to have at least one post baseline visit (visit 8 and beyond).|||participants|||Number
2781830|NCT00657046|Other Pre-specified|Change in Systolic Blood Pressure From Pre-dialysis to Post-dialysis|"Change from baseline (visits 2-7) to end of study (HD visits 14-19) in the drop in systolic blood pressure from pre-hemodialysis to 5 minutes post-hemodialysis.~The baseline value was the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value was defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.|||mmHg||Standard Deviation|Mean
2781831|NCT00657046|Post-Hoc|Systolic Blood Pressure Difference Between Pre-Hemodialysis and Nadir|Change from baseline to end of study (HD visits 14-19) in systolic blood pressure difference between pre-hemodialysis and nadir.|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. One droxidopa 400 mg patient did not have the required nadir blood pressure information for visits 14-19 and was excluded from the analysis.|||mmHg||Standard Deviation|Mean
2781869|NCT00656799|Secondary|Vital Sign: Mean Diastolic Blood Pressure|Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex|||mm Hg||Standard Deviation|Mean
2781832|NCT00657046|Secondary|Change in the Multidimensional Fatigue Inventory (MFI-20)|"Fatigue will be measured by the general fatigue domain (items 1, 5, 12 and 16) of MFI-20 and will be summarized by treatment group and treatment period. The scores per item run from 1 to 5. A higher score indicates more fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). This concerns item: 5 and 16. A total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20.~The value at baseline (visit 7) will be subtracted from the value on treatment (visit 19 or visit 13 if visit 19 is not available)."|6 weeks|Patients must have completed at least visit 14. Three placebo patients did not complete their Multidimensional Fatigue Inventory during this visit.|||units on a scale||Standard Deviation|Mean
2781833|NCT00657046|Secondary|Daily Symptoms Associated With Hemodialysis|"The Daily symptoms associated with hemodialysis score is the sum of an 8 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at fatigability, malaise/weakness, physical disturbance on standing, coldness of limbs, dizziness/lightheadedness, dizziness on standing, general bad feeling, and sleep disorders and asks how each of these items affected the patients daily activities on that day.~The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. Three placebo patients and one droxidopa 600mg patient did not complete their Daily Symptoms Assessments during these visits.|||units on a scale||Standard Deviation|Mean
2781834|NCT00657046|Secondary|Change in the Hypotension-induced Symptom Severity Score|"The hypotension-induced symptom severity score is the sum of a 6 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at cramps, dizziness, headache, nausea, itchiness, and restless legs syndrome experienced during dialysis.~The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 time frame.|||units on a scale||Standard Deviation|Mean
2781835|NCT00657046|Secondary|Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;|Evaluate the efficacy of droxidopa as measured by change in the number of hypotension-induced interventions during hemodialysis (HD) sessions between baseline (visits 2-7) and treatment (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.|||average interventions per session||Standard Deviation|Mean
2781836|NCT00657046|Secondary|Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;|Change between baseline (visits 2-7) and treatment (visits 14-19) in average mean nadir systolic blood pressures during hemodialysis. The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.|||mmHg||Standard Deviation|Mean
2781837|NCT00657046|Primary|Change in Average Mean Arterial Blood Pressure During Hemodialysis|"Change between average baseline (visits 2-7) mean arterial blood pressure during hemodialysis and average treatment (visits 14-19) mean arterial blood pressure during hemodialysis.~The calculation of MAP was based on the systolic (SBP) and diastolic (DBP) blood pressure measurements taken during each valid HD session, using the traditional formula:~MAP = (SBP+2*DBP)/3 for each time-point. The mean of the intradialytic measurements was calculated for each valid HD session, and these daily mean values were averaged across the visits within each period."|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.|||mmHg||Standard Deviation|Mean
2781838|NCT00657020|Secondary|Mean Percentage of Correct Responses During DIA Task|Mean percentage of correct responses during DIA task was determined.|Approximately 2 hours post dose administration|Number of subjects with complete imaging data on both treatments (nicotine and placebo)|||Percentage of responses correct||Standard Deviation|Mean
2781839|NCT00657020|Secondary|Mean Response Time for Correct Responses During DIA Task|"DIA task comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||msec||Standard Deviation|Mean
2781840|NCT00657020|Secondary|Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task|"BOLD fMRI signals evaluated different brain ROIs during DIA task which comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Brain ROIs were right and left parietal cortex, visual cortex, superior occipital cortex and right premotor cortex."|Approximately 2 hours post dose admininstration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||Percentage change in BOLD signal||Standard Deviation|Mean
2781841|NCT00657020|Secondary|Mean Percentage of Correct Responses During RVIP Task|Percentage of correct responses during RVIP task was determined|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||Percentage of responses correct||Standard Deviation|Mean
2781842|NCT00657020|Secondary|Mean Response Time for Correct Responses During RVIP Task|"During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participants responded to single occurrences of the number 0. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||milliseconds (msec)||Standard Deviation|Mean
2781843|NCT00657020|Primary|Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task|"In RVIP task, participant responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participant responded to single occurrences of the number 0. BOLD fMRI signals evaluated different brain regions of interest (ROI) during RVIP task. Brain ROIs identified were right and left anterior insula, anterior putamen, parietal cortex, premotor cortex, visual cortex, dorsal anterior cingulate cortex, substantia nigra and thalamus."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).|||Percentage change in BOLD signal||Standard Deviation|Mean
2781844|NCT00656968|Primary|Number of Participants Who Had Good Drug Compliance|Good drug compliance is defined as taking equal to or more than 80% of eradication medicines|one month after finishing test therapy||||participants|||Number
2781845|NCT00656968|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|one month after finishing study drugs||||participants|||Number
2781846|NCT00656916|Primary|Lung Function Non-deterioration Rate|Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.|Baseline and three months|There was no analysis performed for the protocol due the low enrollment (one participant).|||Percentage (FEV1|||Number
2781847|NCT00656851|Secondary|Fasting Glucose Insulin and HOMA|fasting plasma glucose, insulin concentrations and HOMA-insulin resistance|Week 0 and 16||||mg/dL µU/mL||Standard Error|Mean
2781848|NCT00656851|Secondary|Fasting Lipids and Lipoproteins|fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations|Week 0 and 16||||mg/dL||Standard Error|Mean
2781849|NCT00656851|Primary|Myocardial Fatty Acid Esterification|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction|Weeks 0 and 16||||(% of total fatty acid extraction)||Standard Error|Mean
2781850|NCT00656851|Primary|Myocardial Fatty Acid Oxidation Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.|Weeks 0 and 16||||(nmol palmitate/g heart muscle/min||Standard Error|Mean
2781851|NCT00656851|Primary|Myocardial Fatty Acid Utilization Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).|Weeks 0 and 16||||(nmol palmitate/g heart muscle/min||Standard Error|Mean
2781852|NCT00656851|Primary|Myocardial Glucose Utilization Rate Per Unit Insulin|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.|Weeks 0 and 16||||(nmol glucose/g heart muscle/min/µU insu||Standard Error|Mean
2781853|NCT00656851|Secondary|Myocardial Contractile Function During Systole|Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum|Weeks 0 and 16||||cm/sec||Standard Error|Mean
2781854|NCT00656851|Secondary|Myocardial Contractile Function During Diastole|"Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:~blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or E filling velocity.~residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the A (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio <1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure."|Weeks 0 and 16||||ratio||Standard Error|Mean
2781855|NCT00656851|Primary|Myocardial Glucose Utilization Rate|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.|Weeks 0 and 16||||(nmol glucose/g heart muscle/min||Standard Error|Mean
2781856|NCT00656799|Primary|Rate of Clearance of Rocuronium From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
2781870|NCT00656799|Secondary|Vital Sign: Mean Systolic Blood Pressure|Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex|||mm Hg||Standard Deviation|Mean
2782232|NCT00653263|Primary|Methamphetamine Withdrawal Assessment (MAWA)|The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).|Baseline through week 4||||"Units on a scale"||Standard Deviation|Mean
2781857|NCT00656799|Primary|Rate of Clearance of Sugammadex From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
2781858|NCT00656799|Primary|Rate of Clearance of Rocuronium From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
2781859|NCT00656799|Primary|Rate of Clearance of Sugammadex From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||mL/min||Standard Deviation|Mean
2781860|NCT00656799|Primary|Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||Reduction Ratio||Standard Deviation|Mean
2781861|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement|||Minutes||95% Confidence Interval|Geometric Mean
2781862|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement|||Minutes||95% Confidence Interval|Geometric Mean
2781863|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|Intent To Treat (ITT) group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement|||Minutes||95% Confidence Interval|Geometric Mean
2781864|NCT00656799|Secondary|Number of Participants With Pregnancies at 30 Days Post-dose|Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants|Up to 30 days post -dose|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
2781865|NCT00656799|Secondary|Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium|Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium|Day 1|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
2781866|NCT00656799|Secondary|Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from >= 0.9 to < 0.8 in at least three consecutive measurements.|Day 1|AST consisting of all screened participants who received a dose of sugammadex|||participants|||Number
2781867|NCT00656799|Secondary|Number of Participants With Physical Examinations|Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery|Screening up to day 7|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
2781871|NCT00656799|Secondary|Number of Participants With Medical Device (Near) Incidents|A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health.|Up to day 7|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
2781872|NCT00656799|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect|Up to day 7|AST consisting of all participants who received a dose of sugammadex|||participants|||Number
2781873|NCT00656799|Secondary|Number of Participants With Pre-treatment Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product.|Screening up to Day 1|All Subjects Treated (AST) consisting of participants who received a dose of sugammadex|||participants|||Number
2781874|NCT00656799|Primary|Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement|||Reduction Ratio||Standard Deviation|Mean
2781875|NCT00656669|Secondary|To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy|This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)|All patients who were on paclitaxel plus sunitinib.|||participants|||Number
2781876|NCT00656669|Secondary|Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer||screening through surgery|All patients who had surgery.|||percentage of participants||95% Confidence Interval|Number
2781877|NCT00656669|Secondary|Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)|All patients in the paclitaxel plus sunitinib segment|||mm Hg||Standard Deviation|Mean
2781878|NCT00656669|Primary|Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.|baseline through end of segment 1 (2 weeks)|All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment|||mm Hg||Standard Deviation|Mean
2781879|NCT00656656|Secondary|Number of Patients Who Experienced Side-effects of Treatment|Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.|up to 43 months||||Participants|||Count of Participants
2781880|NCT00656656|Primary|Number of Patients Achieving a Short- and Long-term Remission of Pemphigus|Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.|up to 43 months||||Participants|||Count of Participants
2781881|NCT00656630|Secondary|Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1|The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.|2 weeks|One participant in the naltrexone arm who completed the double blind portion of the trial was unable to be analyzed for change in ACQ-SF Total score due to incomplete ACQ-SF questionnaire at Week 1.|||units on a scale||Standard Deviation|Mean
2781882|NCT00656630|Secondary|Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1|The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.|1 week|Seven participants who completed the double blind portion of the trial were unable to be analyzed for change in PSQI Total score due to incomplete PSQI questionnaire at baseline and/or Week 1.|||units on a scale||Standard Deviation|Mean
2781883|NCT00656630|Secondary|Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1|The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.|1 week||||units on a scale||Standard Deviation|Mean
2781884|NCT00656630|Secondary|Change From Baseline in Standard Drinks Per Week at 1 Week|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.|1 week||||drinks/week||Standard Deviation|Mean
2782162|NCT00654498|Primary|"The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved"|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.|6 weeks of treatment||||Proportion of Patients|||Number
2781885|NCT00656630|Primary|Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period|The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.|1 week||||units on a scale||Standard Deviation|Mean
2781886|NCT00656617|Secondary|Participant Response|Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (< 5% blasts) and of peripheral blood counts (neutrophil count > 1.109/L, platelet count > 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by >50% compared to pretreatment values but above <5%. Complete Response without platelet recovery (CRp) = CR, but platelets <100 x 109/L. Progressive disease (PD) defined as increase of blasts to > 10% after an initial response.|Monitoring with each 4 week cycle, up to 18 cycles of treatment|Four (4) participants were not treated therefore not evaluable for the outcome assessment.|||participants|||Number
2781887|NCT00656617|Primary|Progression Free Survival (PFS) at 7 Months|Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.|PFS Evaluation at 7 months|Four (4) participants did not receive treatment therefore were not evaluable for outcome assessment.|||percentage of participants|||Number
2781888|NCT00656513|Secondary|Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III|The UWHNSS includes ten categories—pain, disfigurement, activity, recreation/entertainment, employment, eating, saliva, taste, speech, mucus/phlegm. Patient scores on the UWHNSS range from 0 to 100 with higher scores indicating declining quality of life. Change in total score was calculated by subtracting baseline from follow-up , thus a positive change score indicates a worsening while a negative change score indicates an improvement.|Baseline and 9 months from randomization.|Eligible randomized patients with both baseline and 9-month UWHNSS total scores.|||units on a scale||Inter-Quartile Range|Median
2781889|NCT00656513|Secondary|Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)|Basal whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.|Pre-treatment to 4, 6, 9 and 15 months from randomization|Eligible randomized patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.|||ml/min||Inter-Quartile Range|Median
2781890|NCT00656513|Secondary|Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)|Stimulated (citric acid primed) whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. Stimulation is elicited by asking patients to rinse 5 ml of 2% citric acid solution in the mouth for 15 seconds and then completely expectorating the citric acid. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.|Baseline, 4, 6, 9 and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.|||ml/min||Inter-Quartile Range|Median
2781891|NCT00656513|Secondary|Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)|Symptom burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning. The domain score is the average of all responses on a given domain and can range from 0 to 4, with higher scores indicating increased symptom burden. Change in symptom burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the symptom burden.|Baseline, 4, 6, 9 and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) XeQOLS scores.|||units on a scale||Inter-Quartile Range|Median
2781892|NCT00656513|Secondary|Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)|Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.|Baseline, 4, 6, and 15 months from randomization|Eligible patients with both baseline and respective follow-up (4,6,15 months) XeQOLS scores.|||units on a scale||Inter-Quartile Range|Median
2781904|NCT00656448|Secondary|Number of Participants With Complete Remission|International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.|After 1 course of therapy, one course is 4 weeks.||||participants|||Number
2783298|NCT00642304|Secondary|Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population|||Days||Standard Deviation|Mean
2781893|NCT00656513|Secondary|Phase II: Pecentage of Patients With Beneficial Treatment Response|This secondary objective was to evaluate the effect of ALTENS treatment on overall radiation-induced xerostomia burden by looking at treatment response. Treatment response was determined by a reduction of at least 20% from baseline to 6 months in the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4. Higher scores indicate increased xerostomia burden. This scale has high reproducibility and sensitivity. For the first and second stage analyses, 4 and 10 patients, respectively, must respond to treatment in order to proceed to the phase III component.|Pre-treatment and 6 months from registration|Eligible patients who started treatment and have both baseline and 6-month XeQOLS scores|||percentage of participants||95% Confidence Interval|Number
2781894|NCT00656513|Primary|Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months|Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.|Baseline (randomization) and 9 months|Eligible randomized patients with both baseline and 9 month XeQOLS scores|||units on a scale||Inter-Quartile Range|Median
2781895|NCT00656513|Primary|Phase II: Treatment Compliance (Number of Compliant Patients)|Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming's two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.|Randomization to 12 weeks|Eligible patients starting protocol treatment|||Participants|||Count of Participants
2781896|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.|Day 0 and Day 28||||milliseconds||Standard Deviation|Mean
2781897|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.|Day 0 and Day 28||||units on a scale||Standard Deviation|Mean
2781898|NCT00656487|Primary|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28|The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.|Day 0 and Day 28||||units on a scale||Standard Deviation|Mean
2781899|NCT00656487|Primary|Plasma Cortisol|Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.|Day 28|Two control participants and one placebo participant who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. The control participants did not have blood drawn; the placebo participant returned a non-detectable value.|||ug/dL||Standard Deviation|Mean
2781900|NCT00656487|Primary|Plasma Norepinephrine|Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.|Day 28|Five control participants who completed the double blind / monitoring portion of the trial did not have samples available for analysis at Day 28. Two participants did not have blood drawn; two additional participant sample results were not returned by the laboratory; and one participant did not return a result due to an ELISA kit error.|||ng/mL||Standard Deviation|Mean
2781901|NCT00656487|Primary|Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period|The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.|Day 28|One participant in the control group who completed monitoring during the double-blind portion of the trial did not complete a Marijuana Withdrawal Checklist at Day 28.|||units on a scale||Standard Deviation|Mean
2781902|NCT00656474|Secondary|Percentage of Wound Epithelialized|The percentage of wound epithelialized was assessed at Day 15 post laser ablation.|Day 15 post laser ablation.|Analysis was Per Protocol.|||percent|||Number
2781903|NCT00656474|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.|||days||95% Confidence Interval|Median
2781905|NCT00656448|Primary|Median Number of Participant Transfusions Required During 12 Weeks of Treatment|"The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group (Procrit) and standard care group (No Procrit). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period."|12 weeks||||Transfusions per Participant||Full Range|Median
2781906|NCT00656370|Secondary|Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)|Participants blinded to the type of infusion were asked to state their preference for the left or right infusion following all infusion day (Day 1) activities and assessments. The preference for the left or right infusion indicated which infusion was preferred: NS or LR.|End of infusion (Day 1)|15 participants were randomized and completed stage 1|||Participants|||Count of Participants
2781907|NCT00656370|Secondary|Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference|Thigh circumference was measured at the level of the angiocatheter with a flexible measuring tape prior to infusion initiation (Baseline), at the midpoint for each infusion, and at the end of each infusion.|Before the infusion (Baseline) until discharge (Day 1)|15 participants were randomized and completed stage 1. Only those participants who experienced a 5% or greater increase in thigh circumference for both infusions were included in the analysis.|||minutes||Standard Deviation|Mean
2781908|NCT00656370|Secondary|Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites|Thigh circumference was measured in centimeters at 7 time points before, during, and after subcutaneous infusion of 500 mL NS or LR solution.|Before the infusion, during the infusion, after the infusion, and discharge (Day 1)|15 participants were randomized and completed stage 1|||percent change||Standard Deviation|Mean
2781909|NCT00656370|Secondary|Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution|The infusion flow rate (mL/h) was derived from the time to subcutaneously (SC) infuse up to 500 mL of NS or LR solution (following SC injection of 150 Units hylenex) by measuring the change in weight of the infusion bag, fluid, and tubing.|During infusion on Day 1|15 participants were randomized and completed stage 1|||mL/hr||Standard Deviation|Mean
2781910|NCT00656370|Secondary|Number of Participants Assessed for Safety Measures|Safety outcome measures included adverse events (AEs), physical examinations (targeted physical examination included lung auscultation for rales, checking for edema, evaluation of infusion sites, positives on a review of systems, and follow-up of findings from previous physical examinations), and vital signs (systolic blood pressure, diastolic blood pressure, heart rate, and respiration rate).|Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days)|15 participants were randomized and completed stage 1|||participants|||Number
2781911|NCT00656370|Primary|The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)|Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.|Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1|15 subjects were randomized and completed stage 1|||mm||Standard Deviation|Mean
2781912|NCT00656305|Secondary|Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline|The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents 'does not interfere' and 10 indicates 'completely interferes'. Responses to the 7 items are averaged to form the pain interference scale score. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.|3 months post treatment|115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.|||score on a scale||Standard Deviation|Mean
2781913|NCT00656305|Secondary|Number of Participants With a Change in Medication Use|"Medication Use change reported from baseline until of study. Medication use is quantified by morphine equivalent usage (measured separately from Responder/Non-responder definition for the primary endpoint)"|3 months post treatment|Only 26 of the 81 subjects in ExAblate treatment arm and 6 of 26 in the sham arm were taking non-opioid medication at baseline.|||Participants|||Count of Participants
2781914|NCT00656305|Primary|Number of Responders|Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.|3 months post treatment|115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.|||Participants|||Count of Participants
2781915|NCT00656292|Secondary|Median Concentration of Tumor Necrosis Factor-Alpha (TNF)|Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||pg/ml||Inter-Quartile Range|Median
2781929|NCT00656084|Primary|Objective Response Rate (CR + PR)|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2781916|NCT00656292|Secondary|Median Concentration of Interleukin-6 (IL-6)|Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||ng/ml||Inter-Quartile Range|Median
2781917|NCT00656292|Secondary|Median Concentration of Creatine Kinase (CK)|A creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 IU/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||U/L||Inter-Quartile Range|Median
2781918|NCT00656292|Secondary|Median Concentration of C-Reactive Protein (CRP)|C-reactive protein (CRP) is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||mg/L||Inter-Quartile Range|Median
2781919|NCT00656292|Secondary|Median Concentration of Alanine Aminotransferase (ALT)|An enzyme normally present in liver and heart cells that is released into the bloodstream when the liver or heart is damaged. The blood ALT levels are elevated with liver damage (for example, from viral hepatitis) or with an insult to the heart (for example, from a heart attack). The normal range is 7 to 56 U/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||U/L||Inter-Quartile Range|Median
2781920|NCT00656292|Primary|Median Concentration of Aspartate Aminotransferase (AST)|Description: AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 U/L.|baseline, at the start of the surgical procedure (0 hrs), 8 hrs, 24 hrs, 48 hrs, 72 hrs||||U/L||Inter-Quartile Range|Median
2781921|NCT00656201|Primary|Percentage of Pregnant Patients After IVF Treatments|Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval|16 weeks|Number of participants for analysis was determined by completion of the IVF cycle using the specified medications, either Crinone or IM Progesterone|||percentage of participants|||Number
2781922|NCT00656175|Primary|Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)|Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.|Baseline and 24 weeks||||cm^2||Inter-Quartile Range|Median
2781923|NCT00656136|Secondary|Objective Response Rate (OR)|OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.|||Percentage of patients with OR||95% Confidence Interval|Number
2781924|NCT00656136|Secondary|Progression-free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.|||Months||95% Confidence Interval|Median
2781925|NCT00656136|Primary|Overall Survival|"Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock.~For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010.~For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013."|From randomization until death or the last patient out date, an average of 12 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.|||Months||95% Confidence Interval|Median
2781926|NCT00656084|Secondary|Progression-free Survival Rate at 1 Year.|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|1 year.|ITT population|||Probability of Progression-free Survival||95% Confidence Interval|Number
2781927|NCT00656084|Secondary|Overall Survival (OS) Rate at 1 Year|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year.|ITT population|||Probability of Survival||95% Confidence Interval|Number
2781928|NCT00656084|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|||months||Full Range|Median
2781930|NCT00656058|Secondary|Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid|Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry|Day 1 of study||||Participants|||Count of Participants
2781931|NCT00656058|Secondary|Percentage Overall 2-Year Survival|Percentage of participants alive at 2 years.|2 years|This is a multicenter study and the number analyzed reflect data for evaluable subjects enrolled at the National Institutes of Health only.|||percentage of participants|||Number
2781932|NCT00656058|Secondary|Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)|Pulmonary function test performed for eligibility and baseline.|Baseline||||Ratio||Full Range|Median
2781933|NCT00656058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 71 months and 17 days||||Participants|||Count of Participants
2781934|NCT00656058|Primary|Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months|FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope.|180 days||||Participants|||Count of Participants
2781935|NCT00656058|Primary|Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature|Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as >15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as <15% change in the absolute FEV-1.|180 days|No data is available for the one missing participant.|||Participants|||Count of Participants
2781936|NCT00656019|Primary|Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer|Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes|10 days to 4 weeks post diagnosis.||||percentage of participants|||Number
2781937|NCT00655928|Primary|Post-operative Plasma IL-6|Plasma IL-6 was measured in duplicate using ELISA.|Post operative, 24 hours||||pg/ml||Inter-Quartile Range|Mean
2781938|NCT00655889|Primary|Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population|||participants|||Number
2781939|NCT00655889|Primary|Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population|||participants|||Number
2781940|NCT00655876|Secondary|Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported||Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start.|The protocol states that this study endpoint will be addressed ONLY if primary outcome results are positive, i.e. support the primary hypothesis of this study. The primary hypothesis was not supported therefore no patients were analyzed for this outcome measure.||||||
2781941|NCT00655876|Secondary|Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment|The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-68. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-E including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points.|Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start.|Patients who consented to collection of patient reported outcomes and quality of life (PRO-QOL) data and had FACT-E scores at baseline and corresponding timepoint|||percentage of participants|||Number
2781942|NCT00655876|Secondary|Endoscopic Complete Response Rate|All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs.|From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks)|Eligible patients who started study treatment and had an endoscopy performed|||percentage of participants|||Number
2782268|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Second Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular itching/burning score over Week 2|||points on a scale||Standard Deviation|Mean
2781943|NCT00655876|Secondary|Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events|Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to 90 days from end of treatment|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2781944|NCT00655876|Secondary|Local Failure (24-month Rate Reported)|Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk.|From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.|All eligible patients|||percentage of participants||95% Confidence Interval|Number
2781945|NCT00655876|Primary|Overall Survival (24-month Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.|From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.|"Eligible patients [We have defined completed as patients who have data available for analysis]"|||percentage of participants||95% Confidence Interval|Number
2781946|NCT00655863|Secondary|Change From Baseline in Endothelial Function Through Pulse Wave Tonometry|Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2781947|NCT00655863|Secondary|Change From Baseline in e-Selectin|The change in e-Selectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
2781948|NCT00655863|Secondary|Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)|The change in ICAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
2781949|NCT00655863|Secondary|Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)|The change in VCAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
2781950|NCT00655863|Secondary|Change From Baseline in Adiponectin|The change in adiponectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||µg/mL||Standard Error|Least Squares Mean
2781951|NCT00655863|Secondary|Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)|The change in hs-CRP collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg/L||Standard Error|Least Squares Mean
2781952|NCT00655863|Secondary|Change From Baseline in Postprandial Proinsulin|The change in postprandial proinsulin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
2781953|NCT00655863|Secondary|Change From Baseline in Postprandial C-Peptide|The change in postprandial C-peptide collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||ng/mL||Standard Error|Least Squares Mean
2781954|NCT00655863|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in fasting plasma glucose collected at each week indicated relative to baseline.|Baseline, Week 4, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2794450|NCT00559988|Secondary|Mean Ventricular Heart Rate Reduction||1 year|Subjects with baseline and 1 year ventricular rate information|||beats per minute||Standard Deviation|Mean
2781955|NCT00655863|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2781956|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||pg/mL||Standard Error|Least Squares Mean
2781957|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Insulin|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||uIU/mL||Standard Error|Least Squares Mean
2781958|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucose|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2781959|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
2781960|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.|Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
2781961|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.|The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
2781962|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.|The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.|Baseline and Week 4.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
2781963|NCT00655863|Primary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.|The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.|||mg.h/dL||Standard Error|Least Squares Mean
2781964|NCT00655850|Secondary|Objective Response Rate|The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0).|Baseline up to 12 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||Participants|||Count of Participants
2781965|NCT00655850|Secondary|Overall Survival (OS)|Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up.|Baseline up to 84 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||months||Full Range|Median
2781966|NCT00655850|Secondary|Number of Participants With Adverse Events|All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0)|Baseline through duration of treatment an average of 1 year|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||participants|||Number
2783299|NCT00642304|Secondary|Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population|||Percentage of participants||95% Confidence Interval|Number
2781967|NCT00655850|Primary|Progression-Free Survival (PFS)|Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0). The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.|Baseline to 24 months|Participants with advanced chemotherapy naïve with non-squamous non-small cell lung cancer.|||months||95% Confidence Interval|Median
2781968|NCT00655824|Secondary|Number of Participants With Normal and Abnormal Electrocardiogram Readings|Electrocardiograms of the participants were taken. The abnormal clinically significant (CS) and not clinically significant (NCS) reading, as determined by the Investigator, were recorded.|8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
2781969|NCT00655824|Secondary|Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK)|Blood samples of participants were collected to assess LDH and CPK. Both tests are performed to evaluate the injury and damage to the body tissue, potentially from B-cell lysis.|8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||U/L||Standard Deviation|Mean
2781970|NCT00655824|Secondary|Assessment of Body Temperature (BT)|The BT of the participants was measured BI and post the first (A) and second (B) infusions (PI) of each cycle to assess the effect of ofatumumab on the BT.The BT of the participants was measured before BI and PI A and B during all 7 treatment courses.Timing for taking BT reading: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.|||Degrees celcius||Standard Deviation|Mean
2781971|NCT00655824|Secondary|Assessment of Heart Rate (HR)|The HR of the participants was measured to assess the condition of the heart.HR was measured BI and post the first (A) and second (B) infusins during all 7 treatment courses.Timing for measuring HR: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
2781972|NCT00655824|Secondary|Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The blood pressure (BP) of the participants was measured before infusion (infu) (BI) and post the first (A) and second (B) infusions (PI) during all 7 treatment courses.Timing for taking BP readings: SBP (BP when the heart is contracting): TC1, 2, 3 (infu A) more than 2 hours PI; TC1, 2 ,3 (infu B) 2 hours PI; TC4, 5, 6, 7 (infu A) 2 hours PI; TC4, 7 (infu B) 2 hours PI; TC5, 6 (infu B) 1 hour PI. For DBP (BP when the heart is resting between beats): TC1, 3 (infu A) more than 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC1, 2, 3, 4, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2781973|NCT00655824|Secondary|Assessment of Blood Urea Nitrogen (BUN)|The blood samples of participants were collected to assess the amount of nitrogen (in the form of urea) in the blood. BUN is evaluated to asssess the renal function of the participants.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||millimoles per liter||Standard Deviation|Mean
2781974|NCT00655824|Secondary|Assessment of Alanine Aminotranferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT)|Blood samples of participants were collected for the evaluation of ALT, AST, AP, and GGT. AST, ALT, AP, and GGT are evaluated to assess the condition of the liver.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Units per liter (U/L)||Standard Deviation|Mean
2781975|NCT00655824|Secondary|Assessment of Total Bilirubin (TB) and Creatinine|Blood samples of participants were collected to evaluatate TB and creatinine levles. TB evlauation is performed to assess the condition of the liver, and possible hemolytic anemia, and the creatinine evaulation is performed to assess the renal condition (condition of the kidneys).|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2781976|NCT00655824|Secondary|Assessment of Total Protein (TP) and Albumin|Blood samples of participants were collected to evaluate TP and albumin. TP can vary depending on auto-immune diseases, and TP and albumin can vary depending on debilitating diseases.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Grams/Liter (g/L)||Standard Deviation|Mean
2783381|NCT00641147|Secondary|Change in Total Polyamines Levels|Polyamine mean level changes (expressed as pg/mg protein) at month 8-baseline|Baseline and 8 months||||pg/mg protein||Standard Deviation|Mean
2781977|NCT00655824|Secondary|Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid|Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Millimoles/liter (mmol/L)||Standard Deviation|Mean
2781978|NCT00655824|Secondary|Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter|Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
2781979|NCT00655824|Secondary|Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter|Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in automimmune diseases. It regulates the immunnoglobin (antibody produced by B cells that is used by the immune system to indentify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood).|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
2781980|NCT00655824|Secondary|Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter|Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
2781981|NCT00655824|Secondary|Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter|Blood samples of participants were collected for the evaulation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||participants|||Number
2781982|NCT00655824|Secondary|Ratio of CD 4+/CD8+|Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Ratio of CD 4+/CD8+ cells||Standard Deviation|Mean
2781983|NCT00655824|Secondary|CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||cells per millimeters cubed (mm^3)||Standard Deviation|Mean
2781984|NCT00655824|Secondary|Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.|||Percentage of CD19+, 4+, 8+, and 3+ BCSs||Standard Deviation|Mean
2781985|NCT00655824|Secondary|Whole Blood Transcriptional Profiles|Blood samples were collected for transcriptomic analysis of messenger ribonucleic acid (mRNA). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781986|NCT00655824|Secondary|Number of Participants With HAHA Response|The host immune response was assessed based on Human Anti-Human Antibodies (HAHA). The serum samples of the participants were collected for the assessment of HAHA. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781987|NCT00655824|Secondary|Number of Participants With the Indicated Pain Score|"The pain score was assessed using the VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2784958|NCT00630539|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear||12 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
2781988|NCT00655824|Secondary|Number of Participants With the Indicated Global Disease Assessment Using the VAS|The participant and the physician independantly used the VAS for overall assessment of the disease. VAS is used to measure the physician's subjective assessment of the participant's RA disease process at the time of the visit. The scale ranged from 0 (extremely well) to 10 (extremely poor). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781989|NCT00655824|Secondary|Number of Participants in the Indicated Categories of the Health Assessment Questionnaire (HAQ)|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The index is calculated by adding all scores, then dividing this score by the total number of components answered. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781990|NCT00655824|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response|EULAR response is based on the DAS score. EULAR response criterion classifies participants as good or moderate responders and non-responders. Good response: DAS28 score <=3.2 and >1.2 improvement from Baseline (IfB) in DAS28 score, Moderate response: DAS28 score <=3.2 and between >0.6 and <=1.2 IfB; DAS28 score between >3.2 and <=5.1 and >1.2 IfB; DAS28 score between >3.2 and <=5.1 and between >0.6 and <=1.2 IfB; DAS28 score >5.1 and >1.2 IfB. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781991|NCT00655824|Secondary|Number of Participants Achieving ACR70|"ACR70 is achieved if the participant has 70% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from 'no pain' to 'severe pain' and the distance marked by the participant from the no pain end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781992|NCT00655824|Secondary|Number of Participants Achieving ACR50|"ACR50 is achieved if the participant has 50% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from 'no pain' to 'severe pain' and the distance marked by the participant from the no pain end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TCand 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781993|NCT00655824|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20|"ACR20 is achieved if the participant has 20% improvement from Baseline in TJC and SJC and in 3 out of 5 of following assessments (A); participant pain A, participant global A, physician global A on a visual analog scale (VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score), participant self-assessed disability, and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population||||||
2781994|NCT00655824|Secondary|Ofatumumab Serum Concentration|Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab.|Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi|FAS Population. Only participants with data available at the particular time points were analyzed.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2781995|NCT00655824|Secondary|Time to Re-treatment in Each Treatment Course|Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3. The study was terminated by the sponsor after Treatment Course 7; therefore, there are no re-treatment data available for Treatment Course 7.|Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants available at the indicated time point were assessed.|||days||Standard Deviation|Mean
2782269|NCT00653224|Secondary|Ocular Itching/Burning Score Over the First Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular itching/burning score over Week 1|||points on a scale||Standard Deviation|Mean
2781996|NCT00655824|Secondary|Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP)|DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to AEs of rash and pruritis. Only participants available at the indicated time point were assessed.|||scores on a scale||Standard Deviation|Mean
2781997|NCT00655824|Secondary|Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour)|DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant's global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to adverse events (AEs) of rash and pruritus. Only participants available at the indicated time point were assessed. Minimum change from baseline is defined as the smallest change at any visit over the course of Weeks 1 to 24 of each treatment cycle.|||scores on a scale||Standard Deviation|Mean
2781998|NCT00655824|Primary|Time to Treatment Withdrawal|Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.|From Baseline up to 144 weeks|Full Analysis Set (FAS) Population: all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment.||||||
2781999|NCT00655811|Secondary|The Difference in Burning/Pain Sensation Ratings Between the Capsaicin or Placebo Application.|This secondary outcome is to see if subjects rated burning/pain differently between the topical capsaicin or placebo application. Participants will rate burning/pain intensity after topical capsaicin and placebo application. The burning/pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable burning/pain sensation). The subjects were also asked to indicate whether they experienced any non-burning/-painful sensation.|1 day||||units on a scale||Standard Deviation|Mean
2782000|NCT00655811|Secondary|Ethnic Differences on the Effects of Topical Capsaicin on Thermal Sensory Thermal Thresholds|A secondary endpoint is to see if topical capsaicin has an effect on warm and heat pain thresholds. Quantitative thermosensory testing was carried out using the Medoc TSA 2001 (Medoc Ltd). The probe baseline temperature was 32 °C and the contact area was 12 cm2. The probe warmed the skin surface at a linear rate of 0·4 °C per second, up to a cut-off of 50 °C. Thermal thresholds were measured in the following order: warmth sensation threshold was measured followed by heat pain detection threshold; each of them was determined four times by the ascending method of limits.|1 day||||Change in degrees Celsius||Standard Error|Mean
2782001|NCT00655811|Primary|Ethnic Differences in Burning Pain Induced by Topical Capsaicin|The primary endpoint is to test the burning pain effect of topical capsaicin by using an continuous visual analog scale (CoVAS) intensity scale as an outcome measure. Participants will rate burning pain intensity after topical capsaicin application. The burning or pain sensation intensity was recorded continuously on a 100-mm COVAS (0, no sensation to 100, maximum, strongest imaginable pain sensation). The subjects were also asked to indicate whether they experienced any nonpainful sensation.|1 day||||units on a scale||Standard Error|Mean
2782002|NCT00655746|Primary|Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||ng∙h/mL||Full Range|Geometric Mean
2782003|NCT00655746|Primary|Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])|area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||ng∙h/mL||Full Range|Geometric Mean
2782004|NCT00655746|Primary|Dasatinib PK Parameter: Plasma Half-Life (T-HALF)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||hours||Standard Deviation|Mean
2782005|NCT00655746|Primary|Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||hours||Full Range|Median
2782037|NCT00655629|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of satisfactory attempts||Standard Deviation|Mean
2782006|NCT00655746|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)||||Participants|||Number
2782007|NCT00655746|Primary|Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose||||ng/mL||Full Range|Geometric Mean
2782008|NCT00655733|Secondary|Complete Remission at Week 12|"Percentage of subjects achieving complete remission (clinical response -100 plus CDAI<150) at week 12 (WOCF).~Complete remission was defined as CDAI score decrease of ≥100 points from baseline and CDAI score <150 in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|12 weeks|ITT|||Participants|||Count of Participants
2782009|NCT00655733|Secondary|Complete Remission at Week 8|"Percentage of subjects achieving complete remission (clinical response -100 plus CDAI<150) at week 8 (WOCF).~Complete remission was defined as CDAI score decrease of ≥100 points from baseline and CDAI score <150 in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|8 weeks|ITT|||Participants|||Count of Participants
2782010|NCT00655733|Secondary|Complete Remission at Week 4|"Percentage of subjects achieving complete remission (clinical response -100 plus CDAI<150) at week 4 (WOCF).~Complete remission was defined as CDAI score decrease of ≥100 points from baseline and CDAI score <150 in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|4 weeks|ITT|||Participants|||Count of Participants
2782011|NCT00655733|Secondary|Clinical Response -70 at Week 12|"Percentage of patients achieving clinical response -70 at Week 12 (WOCF). Clinical response -70 was defined as CDAI score decrease of ≥70 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|12 weeks|ITT|||Participants|||Count of Participants
2782012|NCT00655733|Secondary|Clinical Response -70 at Week 8|"Percentage of patients achieving clinical response -70 at Week 8 (WOCF). Clinical response -70 was defined as CDAI score decrease of ≥70 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|8 weeks|ITT|||Participants|||Count of Participants
2782013|NCT00655733|Secondary|Clinical Response -70 at Week 4|"Percentage of patients achieving clinical response -70 at Week 4 (WOCF). Clinical response -70 was defined as CDAI score decrease of ≥70 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|4 weeks|ITT|||Participants|||Count of Participants
2782014|NCT00655733|Secondary|Remission at Week 12|"Percentage of subjects achieving remission (CDAI<150) at week 12. Remission was defined as CDAI score <150 in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|12 weeks|ITT|||Participants|||Count of Participants
2782055|NCT00655538|Primary|Change From Baseline in Mean BP, Measured by BP Monitoring||Baseline and 4 weeks|not all participants were tested|||mmHg||Standard Error|Mean
2782056|NCT00655538|Primary|Change From Baseline in % Flow Mediated Dilatation (FMD)||Baseline and 12 weeks|10 subjects dropped before week 12|||%FMD||Standard Error|Least Squares Mean
2794924|NCT00556933|Secondary|Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation.||Seven days||||participants|||Number
2782015|NCT00655733|Secondary|Remission at Week 8|"Percentage of subjects achieving remission (CDAI<150) at week 8. Remission was defined as CDAI score <150 in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|8 weeks|ITT|||Participants|||Count of Participants
2782016|NCT00655733|Secondary|Remission at Week 4|"Percentage of subjects achieving remission (CDAI<150) at week 4. Remission was defined as CDAI score <150 in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|4 weeks|ITT|||Participants|||Count of Participants
2782017|NCT00655733|Secondary|Clinical Response -100 at Weeks 12|"Percentage of subjects with CDAI clinical response -100 at Week 12 based on ITT population using the WOCF method to impute missing CDAI scores at Week 12.~Clinical response -100 was defined as CDAI score decrease of ≥100 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|12 weeks|ITT|||Participants|||Count of Participants
2782018|NCT00655733|Secondary|Clinical Response -100 at Weeks 4|"Percentage of subjects with CDAI clinical response -100 at Week 4 based on ITT population using the WOCF method to impute missing CDAI scores at Week 4.~Clinical response -100 was defined as CDAI score decrease of ≥100 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|4 weeks|ITT|||Participants|||Count of Participants
2782019|NCT00655733|Primary|CDAI Clinical Response -100 at Week 8|"Percentage of subjects with CDAI clinical response -100 at Week 8 based on ITT population using the WOCF method to impute missing CDAI scores at Week 8.~Clinical response -100 was defined as CDAI score decrease of ≥100 points from baseline in subjects who had no change in concomitant medications for Crohn's disease except for steroids, which could be tapered after Week 8.~The CDAI consists of eight variables, including Liquid or very soft stools, Abdominal pain, General well-being, Features of extra-intestinal disease, Oplates for diarrhea, Abdominal mass, Hematocrit and Body weight below standard, each weighted according to its ability to be predictive of disease activity. The total score ranges from 0 to over 600 with higher scores indicating higher disease activity or worse outcome."|8 weeks|Intention-to-treat (ITT)|||Participants|||Count of Participants
2782020|NCT00655707|Primary|Number of Participants Without Specific Treatment Related Side Effect|To assess the safety of ascending doses of autologous adult stem cells when introduced into either the hepatic artery or the portal vein and to determine the maximum tolerated dose of stem cells.|12 months||||Participants|||Count of Participants
2782021|NCT00655707|Primary|Number of Patients Who Tolerated the Maximum Dose|To determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein.|12 months||||Participants|||Count of Participants
2782022|NCT00655668|Secondary|Safety|Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)|Up to 24 months|Safety Population (received at least one dose of study drug)|||Participants|||Number
2782023|NCT00655668|Secondary|Progression-Free Survival|Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.|Up to 24 months|Intent-to-treat (ITT) Population|||Months||95% Confidence Interval|Median
2782024|NCT00655668|Secondary|Time-to-Progression|Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.|Up to 24 months|Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival.||||||
2782025|NCT00655668|Secondary|Duration of Response|Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.|Up to 24 months|Intent-to-treat (ITT) Population|||Months||95% Confidence Interval|Median
2782026|NCT00655668|Primary|Participants Categorized by Best Response as Determined by Investigator|"Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):~Complete Response(CR): Complete disappearance of all detectable disease~Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow~Partial Response(PR): >50% decrease in six largest nodes/nodal masses~Stable Disease(SD): Less than PR, but not progressive disease~Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites~Progressive Disease(PD): >=50% increase from low in PR/Non-Responders"|Up to 24 months|Intent-to-treat (ITT) Population|||Participants|||Number
2782076|NCT00654992|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)|estimated glomerular filtration rate (eGFR)as ml/min/1.73m2|during the first 5 days after surgery||||ml/min/1.73m2||Standard Deviation|Mean
2782027|NCT00655642|Primary|Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.|"Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words Least Severe on the left and Most Severe on the right. The possible values range from 0 to 100mm with 0 at the Least Severe extreme and 100 at the Most Severe extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes)."|Baseline and 30 minute assessments|Analysis was performed on all patients who received one of the four treatments and completed the 30-minute VAS assessment. The trial was anticipated to require 18 months to achieve full accrual of patients (n=600). Given that we were at 30% information fraction at 17 months, an unplanned interim analysis was done.|||millimeter||Inter-Quartile Range|Median
2782028|NCT00655629|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of participants|||Number
2782029|NCT00655629|Secondary|Satisfaction With Medication at Week 12 or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with medication at LOCF expressed as the least square mean difference"|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.|||scores on a scale||Standard Deviation|Mean
2782030|NCT00655629|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
2782031|NCT00655629|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
2782032|NCT00655629|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
2782033|NCT00655629|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
2782034|NCT00655629|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
2782035|NCT00655629|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||Sexual Attempts||Standard Deviation|Mean
2782036|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of ejaculation successes||Standard Deviation|Mean
2794925|NCT00556933|Secondary|Acute Rejection Per Kidney Biopsy (Banff Grading Criteria)||Two years||||participants|||Number
2782038|NCT00655629|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of satisfactory erections||Standard Deviation|Mean
2782039|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of successful erections||Standard Deviation|Mean
2782040|NCT00655629|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of subjects|||Number
2782041|NCT00655629|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of successful maintenance||Standard Deviation|Mean
2782042|NCT00655629|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks|SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||percentage of successful penetrations||Standard Deviation|Mean
2782043|NCT00655629|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)|The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data|||scores on a scale||Standard Deviation|Mean
2782044|NCT00655564|Secondary|Safety of Alefacept Using CD4 Counts|Number of participants experiencing CD4 cell counts below 250/uL|52 weeks||||Participants|||Number
2782045|NCT00655564|Primary|Efficacy|Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52|52 weeks||||#Participants|||Number
2782046|NCT00655551|Secondary|Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|0-4 hours post start of the infusion||||subjects|||Number
2782047|NCT00655551|Primary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)||||subjects|||Number
2782048|NCT00655551|Primary|Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Treatment period (up to 7 days)||||subjects|||Number
2782049|NCT00655538|Secondary|Percent Change CETP Mass||baseline to 36 weeks|not all participants were tested|||Percent change in ug/mL||Standard Error|Least Squares Mean
2782050|NCT00655538|Secondary|Change From Baseline in Mean BP, Measured by BP Monitoring||Up to 36 weeks|not all participants were tested|||mmHg||Standard Error|Mean
2782051|NCT00655538|Secondary|Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9||Baseline and 36 weeks|not all participants were tested|||Percent change in ng/mL||Standard Error|Mean
2782052|NCT00655538|Secondary|CETP Activity||Up to 36 weeks|not all participants were tested|||Percent change pMOL/uL/hr||Standard Error|Least Squares Mean
2782053|NCT00655538|Secondary|Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB||Baseline to 36 weeks|not all participants were tested|||Percent change in mg/dL||Standard Error|Least Squares Mean
2782054|NCT00655538|Secondary|Change From Baseline in % FMD||baseline and 36 weeks|not all participants were tested|||%FMD||Standard Deviation|Least Squares Mean
2782057|NCT00655486|Primary|Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis|||subjects|||Number
2782058|NCT00655486|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis|||subjects|||Number
2782059|NCT00655473|Secondary|CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure||Throughout study|Data not collected||||||
2782060|NCT00655473|Secondary|Biomarkers||Up to 24 months|Data not collected||||||
2782061|NCT00655473|Secondary|Blood Lipids,Lipoproteins||Throughout study|Data not collected||||||
2782062|NCT00655473|Secondary|Change From Baseline in Vessel MR Determined Plaque Anatomy||Up to 24 months|Data not collected||||||
2782063|NCT00655473|Secondary|Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance||6 months|Data not collected||||||
2782064|NCT00655473|Primary|Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.||6 months||||Ratio||Standard Error|Least Squares Mean
2782065|NCT00655473|Primary|Percent Change From Baseline in Mean Wall Thickness||24 months||||Percent Change||Standard Error|Least Squares Mean
2782066|NCT00655356|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782067|NCT00655356|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782068|NCT00655356|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782069|NCT00655356|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782070|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.|one week|Number of adverse events by dose and age stratum (18-24 weeks of age) are reported by system organ class and preferred term.|||Adverse Events|||Number
2782071|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (18-24 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.|||ng||Standard Deviation|Mean
2782072|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.|one week|Number of adverse events by dose and age strata (6-<12 and 12- <18 weeks of age) are reported by system organ class and preferred term.|||Adverse Events|||Number
2782073|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (6-<12 and 12- <18 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.|||ng||Standard Deviation|Mean
2782074|NCT00655057|Primary|Change in Dopamine Transporter Binding||Measured at Weeks 0 and 12|The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator’s behalf, data are not available.||||||
2782075|NCT00654992|Primary|Number of Participants Who Had AKI (Acute Kidney Injury)|number of participants who had 50% increase in serum creatinine levels from baseline|at any time within the first 5 days after surgery||||participants|||Number
2782077|NCT00654953|Primary|Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites|Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.|70 days|Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis.|||Days to relapse (two consec coc+ urines)|Participants|Standard Deviation|Mean
2782078|NCT00654940|Secondary|Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment|Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined).|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2.|||scores on scale||Standard Error|Least Squares Mean
2782079|NCT00654940|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively.|||scores on scale||Standard Deviation|Mean
2782080|NCT00654940|Primary|Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale|Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)|Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively.|||scores on scale||Standard Deviation|Mean
2782081|NCT00654927|Secondary|Expanded Disability Status Scale (EDSS)|"Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death)~*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation"|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for data missing|||units on a scale||Standard Deviation|Mean
2782082|NCT00654927|Secondary|Clinician Global Impression of Change (CGIC)|The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse)|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Median
2782083|NCT00654927|Secondary|Subject Global Impression (SGI)|The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
2782084|NCT00654927|Secondary|Timed 25 Foot Walk (T25FW)||Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit|ITT Population. No imputation for missing data|||feet/second||Standard Deviation|Mean
2782085|NCT00654927|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|over 7 years (2004-2011)|Safety Population. No imputation for missing data|||participants|||Number
2782086|NCT00654901|Primary|Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable."|Days 0 up to 7 after any injection|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
2782087|NCT00654901|Primary|Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Antibody persistence and immunogenicity response:~Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0."|Day 0 (pre-booster) and Day 30 (one month post-booster)|Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population).|||Participants|||Number
2782088|NCT00654901|Primary|Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.|Day 0 (pre-booster) and Day 30 (one month post-booster)|Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2782089|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10).~Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 10|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 10.|||Percentage of participants|||Number
2782090|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at Week 6|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6).~Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 6.|||Percentage of participants|||Number
2782091|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
2782092|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
2782093|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
2782094|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
2782095|NCT00654875|Primary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.|||mm Hg||Standard Error|Least Squares Mean
2782096|NCT00654836|Secondary|Overall Survival|Overall survival was measured from treatment initiation to 80 months|80 Months|All enrolled participants are included in this analysis|||Months||95% Confidence Interval|Median
2782097|NCT00654836|Secondary|Response Rate at End of Treatment|Response to treatment was recorded 30 months following treatment initiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions .|30 Months|Of the 32 enrolled participants, two participants did not return to the clinic at 30 months for final evaluation of their response to treatment.|||participants|||Number
2782327|NCT00653159|Secondary|Heavy Bleeding Rates|Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
2782098|NCT00654836|Primary|Progression-free Survival|Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|30 Months|All enrolled participants are included in this analysis|||Months||95% Confidence Interval|Median
2782099|NCT00654784|Secondary|Safety and Tolerability, Assessed by Adverse Events, Blood and Urine Laboratory Measures, ECG.||1 year|||||||
2782100|NCT00654784|Secondary|Skeletal Muscle Strength (Upper Limb, Right and Left): Hand Grip, Elbow Flexors and Elbow Extensors (Upper Limb Score) Timed Walking Test (10 Metres) (Ambulant Patients Only)||1 year|||||||
2782101|NCT00654784|Secondary|Respiratory Function: Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Maximal Inspiratory Pressure (MIP) and Peak Flow (PF)||1 year|||||||
2782102|NCT00654784|Primary|The Relative Change in Peak Systolic Radial Strain of the Left Ventricle (LV) Inferolateral Wall From Baseline (at Screening) to Week 52, Assessed by Color Doppler Myocardial Imaging (CDMI).|"Assessing the peak systolic radial strain of the left ventricle inferolateral wall is used to characterize the cardiac involvement in the DMD patients.~Color Doppler Myocardial Imaging technique is used to quantify regional myocardial function.~The cardiac involvement in DMD is characterized by degeneration, atrophy and fibrosis of the myocardium, leading to dilated cardiomyopathy. The process begins in the posterolateral wall of the left ventricle, with septal involvement appearing at later stages."|baseline and Week 52|At Week 52, data from only 18 patients were available for the primary endpoint analysis due to missing data from 2 patients and the inability to acquire data from a 3rd patient. The efficacy comparison for the primary endpoint was conducted using the LOCF method in the ITT population. In addition, the analysis was repeated using the OC dataset.|||% change in peak systolic||Standard Deviation|Mean
2782103|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18|week 0 - week 18||||participants|||Number
2782104|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15|week 0 - week 15||||participants|||Number
2782105|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782106|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9|week 0 - week 9||||participants|||Number
2782107|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6|week 0 - week 6||||participants|||Number
2782108|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3|week 0 - week 3||||participants|||Number
2782109|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782110|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions|number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782111|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782130|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment|24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)||||mm Hg||Standard Error|Mean
2782112|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782113|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782114|NCT00654745|Secondary|Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12||||participants|||Number
2782115|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18|week 0 - week 18||||participants|||Number
2782116|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15|week 0 - week 15||||participants|||Number
2782117|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
2782118|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9|week 0 - week 9||||participants|||Number
2782119|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6|week 0 - week 6||||participants|||Number
2782120|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3|week 0 - week 3||||participants|||Number
2782121|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
2782122|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
2782123|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12|number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
2782124|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12|week 0 - week 12||||participants|||Number
2782125|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
2782126|NCT00654745|Secondary|Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12||||participants|||Number
2782127|NCT00654745|Secondary|Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.|||mm Hg||Standard Error|Mean
2782128|NCT00654745|Secondary|Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.|||mm Hg||Standard Error|Mean
2782129|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment|Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)||||mm Hg||Standard Error|Mean
2782131|NCT00654745|Primary|Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment|Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.|week 0 - week 12|ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.|||mm Hg||Standard Error|Mean
2782132|NCT00654732|Primary|Event-free Survival (EFS) Rate|EFS will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.|From the start of study treatment up to 3 years||||Participants|||Count of Participants
2782133|NCT00654654|Primary|Independent Panel Global Improvement Assessment Compared to Baseline|An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.|Baseline (prior to treatment) compared to 6 months post last treatment|Number of patients for whom data were available|||participants|||Number
2782134|NCT00654654|Primary|Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment|Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.|Baseline (prior to first treatment) compared to 6 months post last treatment|Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment|||participants|||Number
2782135|NCT00654641|Primary|Total Number of Patients Experiencing a Wound Complication|Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.|6 Weeks post-partum||||Participants|||Number
2782136|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||mg/dL||Standard Deviation|Mean
2782137|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Inter-Quartile Range|Median
2782138|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
2782139|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
2782140|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
2782141|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||mg/dL||Standard Deviation|Mean
2782142|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Inter-Quartile Range|Median
2782143|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
2782144|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
2782145|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement|||Percent Change||Standard Deviation|Mean
2782146|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.|Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 12|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.|||Percentage of participants|||Number
2782328|NCT00653159|Primary|Retention Rate|Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
2782147|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.|Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 6|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.|||Percentage of participants|||Number
2782148|NCT00654615|Secondary|Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)|The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Each question is scored 1-5 with 1 meaning the least amount of severity of pain or difficulty and 5 meaning the maximum amount of pain or difficulty possible. At least 27 of the 30 items must be completed for a score to be calculate. All responses are summed and averaged producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. The overall DASH score ranged between 0-100. A higher score indicated greater disability.|two week post-surgery compared with six weeks post-surgery||||units on a scale||Standard Deviation|Mean
2782149|NCT00654615|Primary|Average Difference Between Michigan Hand Outcomes Questionnaire Scores|Developed at the University of Michigan Department of Plastic Surgery to evaluate outcomes and function in patients who sustain upper extremity injuries. This will be done one week post-surgery compared to six weeks post-surgery comparing the two groups. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. An overall MHQ score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six. The overall MHQ score ranged between 0-100. Higher scores indicate better hand performance.|two week post-surgery compared to six weeks post-surgery||||units on a scale||Standard Deviation|Mean
2782150|NCT00654511|Primary|Morphine Rescue|Total morphine administered in the Post Anesthesia Care Unit (PACU)|up to 24 hours||||micrograms/kilogram||Standard Deviation|Mean
2782151|NCT00654511|Primary|Time to First Morphine Dose|Total minutes from study medication administration to time of first morphine dose.|up to 24 hours||||minutes||Standard Deviation|Mean
2782152|NCT00654498|Secondary|The Change From Baseline in Visual Analogue Scales (VAS)|"VAS is for assessment of RLS-associated pain. The patient was asked How severe was your RLS associated pain in legs or arms during the past week?. No pain:0; very worst pain:10"|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782153|NCT00654498|Secondary|The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale|"RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the intensity of tiredness and sleepiness at day."|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782154|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale|"RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS during the activity at day."|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782155|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.|"RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS during the rest at day."|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782156|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.|"RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS during the night."|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782157|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782158|NCT00654498|Secondary|the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales|RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep.|Baseline and 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2782159|NCT00654498|Secondary|The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10|The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep.|week 6 of treatment||||Proportion of Patients|||Number
2782160|NCT00654498|Secondary|The Proportion of Patient Global Impression(PGI) Responders|"PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of much better or very much better."|6 weeks of treatment||||Proportion of participants|||Number
2782161|NCT00654498|Secondary|The Proportion of IRLS Responders|responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population.|6 weeks of treatment||||Proportion of Patients|||Number
2782163|NCT00654498|Primary|The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).|The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).|Baseline and 6 weeks of treatment|Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint|||Score on a scale||Standard Error|Least Squares Mean
2782164|NCT00654420|Secondary|Phase II: Percentage of Participants With Complete Response (CR) or Partial Response (PR) After Dalotuzumab Plus Erlotinib Treatment (Objective Response Rate [ORR])|"ORR was defined as the percentage of participants in the Phase II analysis population having complete response (CR) or partial response (PR) during the course of the study.~RECIST criteria were used to quantify response rate. For evaluation of target lesions, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. For evaluation of non-target lesions, CR was defined as disappearance of all non-target lesions and normalization of tumor marker level.~Confirmation of response required a second assessment performed 4 weeks or more after the initial assessment. If the confirmation assessment contradicted the initial assessment, it was considered that a response had not been observed. If the confirmation assessment of a participant was not available, that participant was not considered as a responder in the response rate analyses."|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for ORR.|||percentage of participants||95% Confidence Interval|Number
2782165|NCT00654420|Secondary|Phase II: Median Overall Survival (OS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|OS was defined as the time from randomization to death in months due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The nonparametric Kaplan-Meier method was used to estimate the survival time distribution and the median survival of each treatment group.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|Intent to Treat (IIT) Population; all randomized participants in Phase II included regardless of compliance to planned treatment. Phase I participants were not assessed for OS.|||months||95% Confidence Interval|Median
2782166|NCT00654420|Primary|Phase II: Median Progression Free Survival (PFS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|PFS was defined as the time from randomization until either the emergence of radiographic evidence of disease progression or death due to any cause, whichever occurs first. Disease progression was classified as a radiographic assessment of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) using computed tomography (CT) or magnetic resonance imaging (MRI). As pre-specified by the protocol, final analysis of PFS was to take place after approximately 49 PFS events or deaths had occurred in the Phase II part of the trial. A non-parametric Kaplan-Meier method was used to estimate the median PFS time for each treatment group. Participants who discontinued from the study for reasons other than progression of disease were treated as right-censored observations at the time of the last response evaluation. Participants who withdrew from the study due to PD were considered to have a disease progression between the last visit and the time of withdrawal.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for PFS.|||months||95% Confidence Interval|Median
2782167|NCT00654420|Primary|Phase I: Number of Participants Experiencing at Least One Dose-Limiting Toxicity (DLT) Adverse Event (AE) During the First Four Weeks of Dalotuzumab Plus Erlotinib Treatment|"A DLT was an AE related (definitely, probably, or possibly) to study therapy and occurring within first 4 weeks of therapy.~Hematologic DLTs included Grade (Gr)4 neutropenia lasting for ≥7 days, Gr 3/Gr 4 neutropenia with fever >38.5 °C and/or infection requiring antibiotic or anti-fungal treatment, and Gr 4 thrombocytopenia (25.0 x 10^9/L).~Non-hematologic DLT defined as any ≥Gr 3 nonhematologic toxicity, except Gr 3 reversible rash; Gr 3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia occurring in setting of inadequate compliance with supportive care; alopecia; anorexia; asthenia; inadequately-treated hypersensitivity reactions; Gr 3 elevated transaminases (≤1 week duration); or infusion reactions to dalotuzumab.~Any drug-related AEs that led to dose modification of dalotuzumab/erlotinib or any unresolved drug-related toxicity that caused a ≥3 week delay of next scheduled dose of study drug, regardless of Common Terminology Criteria grade, were DLTs."|Up to 4 weeks after initiation of treatment|Participants in the Phase I part of the study who received at least one dose of dalotuzumab in combination with erlotinib during the first 4 weeks of treatment and were evaluable for DLT assessment. Participants in the Phase II part of the study were not evaluated for DLTs.|||participants|||Number
2782168|NCT00654381|Primary|Examination of Long-term Safety of Linagliptin (52-week Treatment)|The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks|52 weeks|The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period|||participants|||Number
2782169|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|52 weeks|The patients who had at least one available baseline FPG measurement under the treatment with linagliptin|||mg/dL||Standard Error|Least Squares Mean
2782233|NCT00653263|Primary|Methamphetamine Selective Severity Assessment (MSSA)|Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.|Baseline through week 4||||"units on a scale"||Standard Deviation|Mean
2782170|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
2782171|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.|||mg/dL||Standard Error|Least Squares Mean
2782172|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 52|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52|52 weeks|For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward|||Participants|||Number
2782173|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 26|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.|||Participants|||Number
2782174|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 12|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.|||Participants|||Number
2782175|NCT00654381|Primary|Change From Baseline in HbA1c at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.|||Percent||Standard Error|Least Squares Mean
2782176|NCT00654381|Primary|Change From Baseline in HbA1c at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.|||Percent||Standard Error|Least Squares Mean
2782177|NCT00654368|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|25 months|Safety Analysis Set|||participants|||Number
2782178|NCT00654368|Secondary|Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 - 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF. n indicates the number of participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
2782179|NCT00654368|Secondary|Change From Month 6 in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; Work time missed and work impairment scores are only calculated for participants who were employed at the time. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
2782180|NCT00654368|Secondary|Change From Month 6 in Short Form 36 Health Survey (SF-36)|"The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant.~The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~End of study is month 24 or early termination."|Month 6, 12, 18 and 24|Intent to treat analysis set with available SF-36 data at month 6; LOCF|||scores on a scale||Standard Deviation|Mean
2782266|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the First Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular tearing/watering score over Week 1|||points on a scale||Standard Deviation|Mean
2782181|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)|The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF|||scores on a scale||Standard Deviation|Mean
2782182|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)|The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set; LOCF|||scores on a scale||Standard Deviation|Mean
2782183|NCT00654368|Secondary|Change From Baseline in Joint Space Narrowing|"X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows:~0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.~End of study is Month 24 or early termination."|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
2782184|NCT00654368|Secondary|Change From Baseline in Joint Erosion Score|X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a Baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
2782185|NCT00654368|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.|||scores on a scale||Standard Deviation|Mean
2782186|NCT00654368|Secondary|Drug Persistence|Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.|Month 6, 12, 18 and 24|Intent to Treat Analysis Set|||percentage of participants|||Number
2782187|NCT00654368|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.|Baseline and Month 6, 12, 18 and 24|Intent to treat; LOCF. The number of participants with available data at Month 6 was 95 and 105 in each treatment group respectively.|||scores on a scale||Standard Deviation|Mean
2782188|NCT00654368|Secondary|Disease Activity Score (DAS) 28 Response|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat population (all randomized participants); Last observation carried forward (LOCF) imputation was used. At Month 6 data were available for 95 and 105 participants in each treatment group respectively.|||Percentage of participants||95% Confidence Interval|Number
2782206|NCT00654095|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.~That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.~Any adverse event that was considered treatment-related was considered an adverse reaction."|Throughout 1 year of study||||Participants|||Number
2782189|NCT00654368|Primary|Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.|Month 6 (randomization) and Month 12|The per protocol population defined as all randomized participants with DAS28 measurements both at the 6- and 12-month visit.|||scores on a scale||Standard Error|Least Squares Mean
2782190|NCT00654355|Secondary|EASI|Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.|Week 4||||units on a scale||Standard Deviation|Mean
2782191|NCT00654355|Secondary|The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.|"Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or No inflammatory signs of AD to '4' = Very Severe Disease with severe erythema and severe papulation/infiltration with oozing/crusting."|Week 4||||% change in IGA||95% Confidence Interval|Median
2782192|NCT00654355|Primary|Adherence|"adherence to topical therapy in children via MEMS cap in a real-life clinic population measured as the % of required applications completed"|Week 4||||percentage of required applicaitons||95% Confidence Interval|Median
2782193|NCT00654329|Secondary|Length of Stay in PACU|Total time from PACU entry until discharge|up to 24 hours||||minutes||Standard Deviation|Mean
2782194|NCT00654329|Primary|Incidence of Pain|Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)|up to 24 hours||||participants|||Number
2782195|NCT00654238|Secondary|Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib).|This is the result of the Kaplan Meier analysis of all patients treated with sorafenib|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|Of the 59 patients that were consented, four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review. Therefore the total number of patients analyzed going forward was 55.|||weeks||95% Confidence Interval|Median
2782196|NCT00654238|Primary|To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|Responses were calculated by total enrolled to each group by histologic subtype.|||Participants|||Count of Participants
2782197|NCT00654186|Secondary|Time to Disesase Progression as Measured by Radiographic Progression|Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.|24 months||||months||Full Range|Median
2782198|NCT00654186|Secondary|Time to PSA Progression|As defined in the protocol PSA progression was an increase of at least 25%|24 months for acrual||||months||Full Range|Median
2782199|NCT00654186|Primary|Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants|"The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions.~Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%."|24 months for acrual|evaluable patients|||percentage of patients|||Number
2782200|NCT00654147|Primary|Time to Virologic Failure|time to virologic failure at week 24 (up to 48 weeks)|week 24 (up to 48 weeks)||||weeks||Standard Deviation|Median
2782201|NCT00654147|Secondary|Study Medication Tolerability|study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment|date started study treatment to first week documented change study treatment up to week 48||||participants|||Number
2782202|NCT00654147|Secondary|Change From Baseline CD4+ and CD8+ Cell Counts|mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms|Baseline, Weeks 16 and 24|Change from baseline compared between arms using repeated measures analysis of covariance. Linear mixed models used to accomplish these analyses.|||cells/mm3||Standard Error|Mean
2782203|NCT00654147|Secondary|Weeks to HIV-1 RNA <200 Copies/ml|time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml|from date of treatment start to first week documented viral suppression||||week to viral supresssion||95% Confidence Interval|Median
2782204|NCT00654147|Secondary|Study Medication Toxicity-related Discontinuation .|grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity|48 weeks||||participants|||Number
2782205|NCT00654147|Primary|Time to Confirmed Virologic Failure|time to confirmed viologic failure at 24 weeks (up to 48 weeks)|weeks|descriptive|||weeks||95% Confidence Interval|Median
2782207|NCT00654069|Primary|SPID48|"Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0).~SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5*.5 + PID1*.5 + PID2*1 + PID3*1 + PID4*1 + PID6*2 +PID12*6 + PID18*6 +PID24*6 + PID30*6 + PID36*6 + PID42*6 + PID48*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings)."|48 hours||||score on a scale||Standard Deviation|Mean
2782208|NCT00654030|Primary|Number of Participants Responding to the Vaccine|The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.|16 weeks after vaccination||||Participants|||Count of Participants
2782209|NCT00654004|Secondary|The Difference in Plasma Insulin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting insulin levels in uU/ml were measured in both groups. The differences between groups were compared with a t-test|Fasting insulin levels uUnits/ml|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. Samples were missing on one subject so 11 subjects were compared to 11 controls.|||uU/ml||Standard Deviation|Mean
2782210|NCT00654004|Secondary|The Difference in Plasma Leptin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting leptin in ng/kg fat mass were measured in both groups (subjects with a long-chain fatty acid oxidation disorder; controls). The differences between groups were compared with a t-test|Fasting leptin levels ng per kg of fat mass|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.|||ng/kg||Standard Deviation|Mean
2782211|NCT00654004|Primary|An Outcome of This Study is the Difference in Glucose Tolerance Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|"Glucose tolerance was estimated by the Matsuda Index using glucose and insulin values from a standard oral glucose tolerance test. The Matsuda Index is calculated by the following formula: 10,000/ sq root of (fasting glucose mg/dl X fasting insulin in units/ml) X (mean glucose (mg/dl) X mean insulin (units/ml) and correlates with insulin sensitivity measured by the gold standard method of a hyperinsulinemic euglycemic clamp. Values of 2.5 or greater are considered insulin sensitive. Values of 2.4 or less are considered insulin resistance.~The Matsuda Index of Insulin Sensitivity was measured in subjects with a long-chain fatty acid oxidation disorder (n=12). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed an oral glucose tolerance test. The difference in Mastuda Index between subjects and age matched controls was compared by t-test."|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.|||units on a scale||Standard Deviation|Mean
2782212|NCT00654004|Secondary|The Difference in Plasma Adiponectin Levels Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting total adiponectin levels in ug/ml were measured in both groups (subjects with a long-chain fatty acid oxidation disorder). The differences between groups were compared with a t-test|Fasting total adiponectin (ug/ml)|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.|||ug/ml||Standard Deviation|Mean
2782213|NCT00654004|Primary|An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|Body composition by DEXA was measured in subjects with a long-chain fatty acid oxidation disorder (n=13). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed body composition measures. The difference in body composition between subjects and age matched controls was compared by t-test.|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.|||percentage of body fat||Standard Deviation|Mean
2782214|NCT00653991|Secondary|Shame Residualized Change|Measures of reported shame (five items from an existing subscale of Watson and Clark's (1994) Positive and Negative Affect Schedule- Expanded Form-- designed to assess State Shame): ashamed, blameworthy, angry at self, disgusted with self, dissatisfied with self. Participants indicate to what extent they experienced emotions that were part of this sub scale, responding on a scale from 1 (very slightly or not at all) to 5(extremely). Values reported represent the mean value per participant on the State Shame subscale; values per participant on this subscale therefore ranged from 1 to 5. Higher scores represent a higher level of reported state shame. Scores on this scale are heavily tailed. Therefore, we have consistently used residualized change scores: This is calculated from baseline to immediate post; negative numbers for residualized change mean reduced shame baseline to immediate post.|Measured at baseline and Immediate post|"At baseline 443 (of 444) SOLVE-IT and 491 WLC filled out the shame measure, but 7 per condition responded with refuse to answer. A technical glitch post-game (that affected immediate post baseline measures only) resulted in 337 participants in SOLVE-IT but 482 WLC responding to immediate post."|||score on a scale||Standard Deviation|Mean
2782230|NCT00653328|Primary|Median Time to Tumor Progression|Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination|Date on study to the date of measured progressive disease, every 2 cycles (2 months)|Patients available for measurement of tumor response. One patient withdrew after beginning treatment.|||Months||Full Range|Median
2782231|NCT00653263|Secondary|Hamilton Depression Rating Scale (HAM-D) Rating Score|Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.|4 weeks||||"Units on a scale"||Standard Deviation|Mean
2782215|NCT00653991|Primary|Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months|Counts of unprotected anal intercourse (one each for insertive and receptive) in the past 3 months with a non-primary partner were reported by participants at baseline, and 6 month follow-up. Reports of insertive and receptive anal intercourse per time period were summed. Change in unprotected anal intercourse from baseline, was calculated at 6 months using residualized change scores (regressing 6-month reported UAI (Y) on baseline UAI. Negative numbers reflect a reduction in UAI over time). Raw counts of UAI are heavily tailed, but residualized change scores are normally distributed.|Measured at baseline and 6 month follow-up|Here we use only complete data for a given analysis. Using Mahlolanobis distance critical values 11 participants in the SOLVE-IT group and 5 participants in the Waitlist Control were multivariate outliers.|||Change in Counts of UAI at 6 months||Standard Deviation|Mean
2782216|NCT00653991|Primary|Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months|Counts of unprotected anal intercourse (one each for insertive and receptive; UAI) in the past 3 months with a non-primary partner were reported by participants at baseline, and 3 month follow-up. Reports of insertive and receptive anal intercourse per time period were summed. Change in unprotected anal intercourse was calculated at 3 months using residualized change scores (regressing 3-month reported UAI (Y) on baseline UAI. Negative numbers reflect a reduction in UAI over time). Although raw counts of UAI are heavily tailed, residualized change scores yield a normal distribution.|Measured at baseline and 3 month follow-up|In SOLVE-IT at 3 months, 10 multivariate outliers were excluded based on Mahalanobis distance; in Wait-list Control 12 multivariate outliers were excluded.|||Res. Change in Counts of UAI at 3 months||Standard Deviation|Mean
2782217|NCT00653939|Secondary|Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)||Day 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population|||participants|||Number
2782218|NCT00653939|Secondary|Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)||Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)|Safety Population|||participants|||Number
2782219|NCT00653939|Secondary|Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)||Days 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population|||participants|||Number
2782220|NCT00653939|Primary|Progression Free Survival (PFS) in the Intent-to-Treat Population|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.|Six 21-day cycles|Intent-to-Treat|||months||95% Confidence Interval|Median
2782221|NCT00653939|Secondary|Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population||Until death or lost to follow-up, up to 12 months since randomization|Intent-to-Treat|||Months||95% Confidence Interval|Median
2782222|NCT00653939|Secondary|Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population|Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.|Six 21-day cycles|Intent-to-Treat|||participants|||Number
2782223|NCT00653861|Secondary|Nasolabial Fold (NLF) Severity|Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.|2 weeks|ITT|||Units on a scale||Standard Deviation|Mean
2782224|NCT00653861|Secondary|Comparative Pain|A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day|ITT|||Percent of Participants|||Number
2782225|NCT00653861|Primary|Procedural Pain Score|Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2782226|NCT00653523|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.~That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.~Any adverse event that was treatment-related was considered an adverse reaction."|Throughout 1 year of study||||Participants|||Number
2782227|NCT00653328|Secondary|Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Weekly for 2 weeks, then monthly for 5 months||||participants|||Number
2782228|NCT00653328|Secondary|Overall Survival||Date on study to date of death from any cause|All patients who received treatment. Two patients alive at last follow-up.|||Months||Full Range|Median
2782229|NCT00653328|Secondary|Number of Patients With Objective Response|"Patient response to treatment:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|At month 2 and monthly thereafter to cessation of treatment|Patients who were available for measurement of tumor response.One patient withdrew after beginning treatment and was not available for measurement.|||participants|||Number
2782234|NCT00653224|Secondary|Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population|||participants|||Number
2782235|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 2|Number of participants from the ITT population with available ESS score at Week 2 and at Baseline|||points on a scale||Standard Deviation|Mean
2782236|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 1|Number of participants from the ITT population with available ESS score at Week 1 and at Baseline|||points on a scale||Standard Deviation|Mean
2782237|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782238|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782239|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782240|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782241|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782242|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782243|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782329|NCT00653133|Primary|Complications of Peripheral Nerve Block|Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic|Preoperative through 3 days post operative|Intent to treat (ITT)|||participants|||Number
2782244|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782245|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782246|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782247|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782248|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782249|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782250|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782251|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782252|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782267|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2794926|NCT00556933|Secondary|Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents)||Two years||||participants|||Number
2782253|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782254|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782255|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782256|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline|||percent change||Standard Deviation|Mean
2782257|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline|||percent change||Standard Deviation|Mean
2782258|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline|||percent change||Standard Deviation|Mean
2782259|NCT00653224|Secondary|Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population|||participants|||Number
2782260|NCT00653224|Secondary|Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population|||participants|||Number
2782261|NCT00653224|Secondary|Ocular Redness Score Over the Total Treatment Period (14 Days)|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular redness score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782262|NCT00653224|Secondary|Ocular Redness Score Over the Second Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular redness score over Week 2|||points on a scale||Standard Deviation|Mean
2782263|NCT00653224|Secondary|Ocular Redness Score Over the First Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular redness score over Week 1|||points on a scale||Standard Deviation|Mean
2782264|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782265|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Second Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular tearing/watering score over Week 2|||points on a scale||Standard Deviation|Mean
2799126|NCT00529542|Secondary|Total Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
2782270|NCT00653224|Secondary|Ocular Pruritus Score Over the Total Treatment Period (14 Days)|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782271|NCT00653224|Secondary|Ocular Pruritus Score Over the Second Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular pruritus score over Week 2|||points on a scale||Standard Deviation|Mean
2782272|NCT00653224|Secondary|Ocular Pruritus Score Over the First Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular pruritus score over Week 1|||points on a scale||Standard Deviation|Mean
2782273|NCT00653224|Secondary|Post-nasal Drip Score Over the Total Treatment Period (14 Days)|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782274|NCT00653224|Secondary|Post-nasal Drip Score Over the Second Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available post-nasal drip score over Week 2|||points on a scale||Standard Deviation|Mean
2782275|NCT00653224|Secondary|Post-nasal Drip Score Over the First Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available post-nasal drip score over Week 1|||points on a scale||Standard Deviation|Mean
2782276|NCT00653224|Secondary|Nasal Pruritus Score Over the Total Treatment Period (14 Days)|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782277|NCT00653224|Secondary|Nasal Pruritus Score Over the Second Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal pruritus score over Week 2|||points on a scale||Standard Deviation|Mean
2782278|NCT00653224|Secondary|Nasal Pruritus Score Over the First Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal pruritus score over Week 1|||points on a scale||Standard Deviation|Mean
2782279|NCT00653224|Secondary|Nasal Congestion Score Over the Total Treatment Period (14 Days)|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal congestion score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782280|NCT00653224|Secondary|Nasal Congestion Score Over the Second Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal congestion score over Week 2|||points on a scale||Standard Deviation|Mean
2782281|NCT00653224|Secondary|Nasal Congestion Score Over the First Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal congestion score over Week 1|||points on a scale||Standard Deviation|Mean
2782282|NCT00653224|Secondary|Rhinorrhea Score Over the Total Treatment Period (14 Days)|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782283|NCT00653224|Secondary|Rhinorrhea Score Over the Second Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available rhinorrhea score over Week 2|||points on a scale||Standard Deviation|Mean
2782284|NCT00653224|Secondary|Rhinorrhea Score Over the First Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available rhinorrhea score over Week 1|||points on a scale||Standard Deviation|Mean
2782285|NCT00653224|Secondary|Sneezing Score Over the Total Treatment Period (14 Days)|The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available sneezing score over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782286|NCT00653224|Secondary|Sneezing Score Over the Second Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available sneezing score over Week 2|||points on a scale||Standard Deviation|Mean
2782287|NCT00653224|Secondary|Sneezing Score Over the First Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available sneezing score over Week 1|||points on a scale||Standard Deviation|Mean
2782288|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TOSS over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782330|NCT00653068|Secondary|Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy|Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.|During protocol therapy up to 1 year after enrollment.|68 eligible patients were evaluable|||Participants|||Count of Participants
2782289|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Second Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TOSS over Week 2|||points on a scale||Standard Deviation|Mean
2782290|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the First Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TOSS over Week 1|||points on a scale||Standard Deviation|Mean
2782291|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TNSS over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782292|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Second Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TNSS over Week 2|||points on a scale||Standard Deviation|Mean
2782293|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the First Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TNSS over Week 1|||points on a scale||Standard Deviation|Mean
2782294|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available T4SS over the Total Treatment period|||points on a scale||Standard Deviation|Mean
2782295|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Second Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T4SS over Week 2|||points on a scale||Standard Deviation|Mean
2782296|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the First Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available T4SS over Week 1|||points on a scale||Standard Deviation|Mean
2782297|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the Second Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T5SS over Week 2|||points on a scale||Standard Deviation|Mean
2782298|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the First Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided.|Over week 1|Number of participants from the ITT population with available T5SS over Week 1|||points on a scale||Standard Deviation|Mean
2782299|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782300|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782301|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782302|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782303|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782304|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782305|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782306|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782307|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782308|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782309|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782310|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782311|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782312|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782313|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782331|NCT00653068|Primary|Toxic Death|The number of patients who experience death that is considered to be primarily attributable to complications of treatment.|During and after completion of study treatment up to 1 year after enrollment.|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.|||Participants|||Count of Participants
2782314|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782315|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782316|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782317|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782318|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782319|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782320|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 2|Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline|||points on a scale||Standard Deviation|Mean
2782321|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 1|Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline|||points on a scale||Standard Deviation|Mean
2782322|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2782323|NCT00653224|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period|||points on a scale||Standard Deviation|Mean
2782324|NCT00653159|Secondary|Device Satisfaction Rates|"Satisfaction rate is the proportion of subjects who report being happy or very happy with their assigned intrauterine contraceptive method on the date of their 6 month study visit."|6 months|Only subjects who were not lost to follow-up at 6 months were included in this analysis.|||percentage of subjects completing study|||Number
2782325|NCT00653159|Secondary|Expulsion Rates|Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
2782326|NCT00653159|Secondary|Pregnancy Rates|Proportion of subjects who became pregnant within 6 months of IUD insertion|6 months|All study participants were included in the analysis.|||percentage of randomized subjects|||Number
2782332|NCT00653068|Primary|Overall Survival (OS)|Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.|||Estimated Probability||95% Confidence Interval|Number
2782333|NCT00653068|Primary|Event-free Survival|Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.|||Estimated probability||95% Confidence Interval|Number
2782334|NCT00652951|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within the 31-day (Days 0-30) after booster vaccination|The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.|||Participants|||Count of Participants
2782335|NCT00652951|Secondary|Number of Subjects With Solicited General Symptoms - Booster Vaccination.|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following booster dose|The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.|||Participants|||Count of Participants
2782336|NCT00652951|Secondary|Number of Subjects With Solicited Local Symptoms -Booster Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters from injection site.|During the 4-day (Days 0-3) post-vaccination period following booster dose|The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.|||Participants|||Count of Participants
2782337|NCT00652951|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Throughout the entire study period (up to Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782338|NCT00652951|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within the 31-day (Days 0-30) post-primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782339|NCT00652951|Secondary|Number of Subjects With Solicited General Symptoms - Primary Vaccination|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782340|NCT00652951|Secondary|Number of Subjects With Solicited Local Symptoms - Primary Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (>) 30 millimeters from injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782341|NCT00652951|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.|Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).|Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782379|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination SAEs|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~* Grade 3 SAEs were not assessed."|Throughout the safety follow-up (month 7 up to Month 12).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782342|NCT00652951|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.|Acquisition of new H. influenzae* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.|Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782343|NCT00652951|Secondary|Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.|Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).|One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782344|NCT00652951|Secondary|Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.|Positive cultures of H. influenzae* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). *Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.|One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)|The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.|||Participants|||Count of Participants
2782345|NCT00652951|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782346|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782347|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.|Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2782348|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.|Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2782349|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782350|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.|Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2782523|NCT00651664|Secondary|Peak/Trough Ratio for Aliserib 21 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 14 and 21|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ratio||Standard Deviation|Mean
2782351|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.|Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2782352|NCT00652951|Secondary|Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.|A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations < 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).|One month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2782353|NCT00652951|Secondary|Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.|Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782354|NCT00652951|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2782355|NCT00652951|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.|Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782356|NCT00652951|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination|Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.|Prior to (Month 9) and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2782357|NCT00652951|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.|Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.|Prior to (Month 9) and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2782358|NCT00652951|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|Prior (Month 9) to and one month after (Month 10) the administration of the booster dose|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782359|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|Prior to (Month 9) and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782537|NCT00651664|Secondary|Peak/Trough Ratio for Aliserib 7 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Day 7|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for analysis.|||ratio||Standard Deviation|Mean
2782360|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination|Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|Prior (Month 9) to and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2782361|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.|Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|Prior (Month 9) to and one month after the administration of the booster dose(Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2782362|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|Prior (Month 9) to and one month after the administration of the booster dose(Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782363|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination|Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.|Prior (Month 9) to and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2782364|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination|Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|Prior to (Month 9) and one month after the administration of the booster dose (Month 10)|The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2782365|NCT00652951|Secondary|Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.|Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Titers||95% Confidence Interval|Geometric Mean
2782366|NCT00652951|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values > 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration > 100 mIU/mL or CLIA concentration > 10 mIU/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||mIU/mL||95% Confidence Interval|Geometric Mean
2782367|NCT00652951|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination|Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782368|NCT00652951|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination|Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||µg/mL||95% Confidence Interval|Geometric Mean
2783610|NCT00640224|Secondary|Total Testosterone at Baseline and 6 Months|Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
2782369|NCT00652951|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination|Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||IU/mL||95% Confidence Interval|Geometric Mean
2782370|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Titers||95% Confidence Interval|Geometric Mean
2782371|NCT00652951|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination|Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||µg/mL||95% Confidence Interval|Geometric Mean
2782372|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.|Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Participants|||Count of Participants
2782373|NCT00652951|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Titers||95% Confidence Interval|Geometric Mean
2782374|NCT00652951|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination|Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.|At Month 3, one month after the administration of the third vaccine dose|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||Participants|||Count of Participants
2782375|NCT00652951|Primary|Antibody Concentration Against Protein D (PD) - Primary Vaccination|Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782376|NCT00652951|Primary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.|At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine|The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.|||μg/mL||95% Confidence Interval|Geometric Mean
2782377|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the safety follow-up (month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782378|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782380|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Related SAEs were SAEs assessed by the investigators as related to the vaccination.~* Grade 3 SAEs were not assessed."|Throughout the active phase of the study (up to Month 7).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782381|NCT00652938|Secondary|Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination."|During the 30-day period (Days 0 - 29) following any vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782382|NCT00652938|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782383|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.~Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas."|During the 7-day (Days 0-6) period following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782384|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination."|During the 7-day (Days 0-6) period following vaccination.|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782385|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms include injection site pain, redness and swelling.~Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm."|During the 7-day period (Days 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782386|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms included injection site pain, redness and swelling.~Any solicited local symptom is occurence of a symptom regardless of its intensity."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782387|NCT00652938|Secondary|Anti-HBs Antibody Titers|"Anti-HBs antibody titers are given as GMTs in mIU/mL.~Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2782388|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.~Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2782389|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.~Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2782390|NCT00652938|Secondary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).~Only groups which had received the HPV vaccine were included in the analysis.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782422|NCT00652743|Secondary|Number of Seropositive Subjects for H5N1 HI Antibodies|Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782391|NCT00652938|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.~Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2782392|NCT00652938|Secondary|Anti-HBs Antibody Titres|"Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.~Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2782393|NCT00652938|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.~Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2782394|NCT00652938|Primary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).~Only groups which had received the HPV vaccine were included in the analysis.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2782395|NCT00652938|Primary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.~Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2782396|NCT00652938|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.~Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2782397|NCT00652899|Secondary|Median Overall Survival Number of Days Patients Alive After Treatment|Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.|From first date on-study (treatment) to date of death||||Days||95% Confidence Interval|Median
2782398|NCT00652899|Secondary|Median Number of Days to Progression|Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) > or = 20% increase in sum of all target or any new lesions.|From date of first treatment to disease progression||||Days||95% Confidence Interval|Median
2782399|NCT00652899|Secondary|Number of Patients Per Disease Response|Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion.|1 Month After Natural Killer Cell Infusion (Day 30)|Includes 12 patients that completed treatment per protocol criteria.|||Patients|||Number
2782400|NCT00652899|Primary|Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product|Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.|Day 12-14||||Patients|||Number
2782401|NCT00652834|Primary|GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score|"The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms."|one month||||GSRS score||95% Confidence Interval|Mean
2782402|NCT00652743|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Month 12 up to Month 48)|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782538|NCT00651664|Secondary|Accumulation Ratio (Rac) for Alisertib 7 Day Dosing|Rac for Day 7=AUCt Day 7/AUCt Day 1.|Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Day 7|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for analysis Rac.|||ratio||Standard Deviation|Mean
2782403|NCT00652743|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782404|NCT00652743|Secondary|Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
2782405|NCT00652743|Secondary|Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
2782406|NCT00652743|Secondary|Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
2782407|NCT00652743|Secondary|Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.|At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
2782408|NCT00652743|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (From Month 12 to Month 48)|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2782409|NCT00652743|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptom|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who has their symptom sheets filled in.|||Participants|||Count of Participants
2782410|NCT00652743|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36|The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2782411|NCT00652743|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off|Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.|At Months 6/12/36 + 21 days, 12, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2783611|NCT00640224|Secondary|Total Fat Mass at Baseline and 6 Months|DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass.|Baseline and 6 months||||Kg||Standard Error|Mean
2782412|NCT00652743|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005.|At Months 6/12/36 + 21 days, 12, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782413|NCT00652743|Secondary|Booster Vaccine Response for Neutralizing Antibodies|Booster vaccine response was defined as: for pre-booster antibody titer < 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 6/12/36 + 21 days, 12, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782414|NCT00652743|Secondary|Titers for Serum Neutralizing Antibodies|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 6/12, 6/12 + 21 days, 24, 36 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782415|NCT00652743|Secondary|Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 36, 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782416|NCT00652743|Secondary|Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24 and 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Participants|||Count of Participants
2782417|NCT00652743|Secondary|Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 36, 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2782418|NCT00652743|Secondary|Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24, 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Fold change||95% Confidence Interval|Geometric Mean
2782419|NCT00652743|Secondary|Booster Vaccine Response for H5N1 HI Antibodies|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 36, 42 and 48|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782420|NCT00652743|Secondary|Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies|Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24 and 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Participants|||Count of Participants
2782421|NCT00652743|Secondary|Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24 and 30|The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.|||Participants|||Count of Participants
2782453|NCT00652366|Secondary|OS Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.|BL and weekly thereafter for up to 46 months.|FAS|||months||95% Confidence Interval|Median
2782423|NCT00652743|Secondary|Number of Seropositive Subjects for H5N1 HI Antibodies|Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Months 18, 24, 30 and 36|The analysis was performed on the ATP cohort for persistence at Month 12-18 (M12-18) and at Month 24-30 (M24-30), which included all evaluable subjects not boosted (M12-18) and boosted (M24-30) at M12, not boosted at M12 but boosted at M6 or neither boosted at M6 nor at M12 (M24-30).|||Participants|||Count of Participants
2782424|NCT00652743|Primary|Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782425|NCT00652743|Primary|Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease|Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782426|NCT00652743|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 +21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2782427|NCT00652743|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2782428|NCT00652743|Primary|Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Month 36 + 21 Days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782429|NCT00652743|Primary|Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12|Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782430|NCT00652743|Primary|Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782431|NCT00652743|Primary|Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 36 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782432|NCT00652743|Primary|Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2782454|NCT00652366|Secondary|Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|BL and weekly thereafter for up to 46 months.|FAS|||percentage of participants|||Number
2782433|NCT00652743|Primary|Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.|At Month 12 + 21 days|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2782434|NCT00652626|Primary|Number of Participants With Adverse Events (AEs)|"A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:~Results in death;~Is life threatening;~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Is medically important.~The Investigator assessed each AE for potential causal relationship between the event and study drug.~The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5)."|Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).|Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.|||participants|||Number
2782435|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine|The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||liters||Geometric Coefficient of Variation|Geometric Mean
2782436|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine|The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2782437|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine|The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||hours||Geometric Coefficient of Variation|Geometric Mean
2782438|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine|The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||hours||Full Range|Median
2782439|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine|The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2782440|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:~AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2782441|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine|The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2782442|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine|"The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function.~Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2782443|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F)|The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||liters||Geometric Coefficient of Variation|Geometric Mean
2782444|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F)|The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2782445|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½)|The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||hours||Geometric Coefficient of Variation|Geometric Mean
2782446|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax)|The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||hours||Full Range|Median
2782447|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax)|The maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2782448|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:~AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2782449|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point|Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2782450|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose|Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2782451|NCT00652366|Secondary|PFS Assessed From the Start of 4-Week Run-In|PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS; only participants with an event of PD or death were included in the analysis.|||weeks||95% Confidence Interval|Median
2782452|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In|PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS|||percentage of participants|||Number
2786602|NCT00618072|Secondary|HDL|HDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest.|6 months||||mg/dl||Standard Error|Mean
2782455|NCT00652366|Secondary|Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST|Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS|||percentage of participants||95% Confidence Interval|Number
2782456|NCT00652366|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST|CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS|||percentage of participants||95% Confidence Interval|Number
2782457|NCT00652366|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST|BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS|||percentage of participants||95% Confidence Interval|Number
2782458|NCT00652366|Secondary|PFS Assessed From Point of Randomization|PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS|||weeks||95% Confidence Interval|Median
2782459|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization|Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS|||percentage of participants|||Number
2782460|NCT00652366|Primary|OS Assessed From Point of Randomization|OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS|||months||95% Confidence Interval|Median
2782461|NCT00652366|Primary|Percentage of Participants Who Died Assessed From Point of Randomization|Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|Full analysis set (FAS): all randomized participants.|||percentage of participants|||Number
2782462|NCT00652340|Secondary|Overall Survival||Randomization and every cycle||||months||95% Confidence Interval|Median
2782463|NCT00652340|Primary|Time to Disease Progression (TDP)||Baseline and every other cycle.|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.13 between the proportions of patients who are progression free in AP/E (0.34) and P/E (0.21) after 5 months; an overall sample size of 115 patients (77 in AP/E and 38 in P/E) will be randomized in a 2:1 ratio in this study.|||months||95% Confidence Interval|Median
2782464|NCT00652327|Primary|Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment||Assessed at the end of 8 weeks of treatment (from baseline to endpoint)|The population analyzed (intent-to-treat [ITT]) included all participants who had a post-randomization LDL-C laboratory evaluation. As such, 20 of the 83 participants who received treatment assignment were excluded from the ITT. The 5 participants who discontinued were included in the ITT as each had a post-randomization LDL-C lab evaluation.|||Percentage change||Standard Deviation|Mean
2782465|NCT00652314|Secondary|Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters||0 day, 30 day, and 60 days post procedure||||participants|||Number
2782466|NCT00652314|Secondary|Safety: Incidence Rate of Device-related Adverse Events||Procedure, up to 60 days post procedure||||participants|||Number
2782467|NCT00652314|Secondary|Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)|Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.|Procedure (application through end of procedure)|Note that the number of participants analyzed (62 and 33) applies to each set of five rows below which apply to the following categories: Ease of application to bleeding site, conformance to tissue surfaces, ease of delivery to hard to reach surfaces, and ease of preparation for use.|||participants|||Number
2782468|NCT00652314|Secondary|Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)||Procedure, up to 6 minutes post procedure||||participants|||Number
2782539|NCT00651664|Secondary|Terminal Half-Life (t1/2) for Alisertib 7 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Day 7 or 8 (BID arms)|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for t1/2 analysis.|||hr||Standard Deviation|Mean
2782469|NCT00652314|Primary|The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.|Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.|Time to hemostasis (minutes)||||Time to hemostasis (minutes)||Standard Deviation|Mean
2782470|NCT00652145|Secondary|Fecal Calprotectin <200 µg/g||at 6 weeks after randomization|25 participants with baseline FC>=200ug/g|||participants|||Number
2782471|NCT00652145|Secondary|Fecal Calprotectin Level <100 µg/g||at 6 weeks after randomization|38 participants with baseline FC>=100ug/g|||participants|||Number
2782472|NCT00652145|Primary|Fecal Calprotectin Level <50µg/g||6 weeks after randomization||||participants|||Number
2782473|NCT00652093|Secondary|Final Pain|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782474|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782475|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|study visit||||units on a scale||Standard Deviation|Mean
2782476|NCT00652093|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782477|NCT00652093|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782478|NCT00652093|Secondary|Roland Morris Disability Questionnaire (RMDQ)|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782479|NCT00652093|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782480|NCT00652093|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2782481|NCT00652093|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||minutes||Standard Deviation|Mean
2782482|NCT00652093|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||meters||Standard Deviation|Mean
2782562|NCT00651482|Secondary|Objective Response (OR) Duration||24 months||||weeks||Full Range|Median
2782563|NCT00651482|Secondary|Objective Response (OR)|Number of subjects with objective response (OR)|24 months||||participants|||Number
2782483|NCT00652093|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale * minutes||Standard Deviation|Mean
2782484|NCT00652093|Primary|Time to First Symptoms (Tfirst) of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.|study visit|The analyses included all 24 enrolled randomized subjects based on inclusion/exclusion criteria except for three who withdrew from trial prior to completion of study. One dropped out (physician decision) due to an adverse event (AE) (dizzy) and two dropped due to scheduling. This singular AE is not included in the AE reporting below.|||minutes||Standard Deviation|Mean
2782485|NCT00652080|Secondary|Percentage of Participants With a Complete Response|"To obtain a preliminary determination of the efficacy of API 31510 cream 3%,topically applied to in situ cutaneous squamous cell carcinomas.~The subject was considered to have had a complete response only if the histological examination of the target lesion was negative."|6 weeks|"Intent-to-Treat (ITT) Population: All subjects who were dispensed the study drug were included in this population.~Per Protocol (PP) Population: All subjects who had SCCIS confirmed via histological results at baseline, had a Week 6 histological examination, and did not miss any interim visits."|||Participants|||Count of Participants
2782486|NCT00652080|Primary|Number of Participants With Adverse Events|To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS).|6 weeks|Safety Population: All subjects who took at least one dose of the investigational product.|||Participants|||Count of Participants
2782487|NCT00652028|Primary|Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)|Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period|During the treatment period (Approximately 24 hours)|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||participants|||Number
2782488|NCT00652028|Primary|Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score|"RSS Score range from 1 to 6:~Patient is anxious and agitated or restless, or both.~Patient is cooperative, orientated and tranquil.~Patient responds to command only.~Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus.~Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.~Patient exhibits no response to stimulus."|Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||units on a scale||Standard Deviation|Mean
2782489|NCT00652028|Primary|Clearance (CL)|Clearance (CL) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||Litre/hour||Standard Deviation|Mean
2782490|NCT00652028|Primary|Volume of Steady State Distribution (Vss)|Volume of steady state distribution (Vss) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||Litre||Standard Deviation|Mean
2782491|NCT00652028|Primary|Plasma Concentration at Steady State (Css)|Plasma concentration at steady state (Css) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||picograms per milliliter||Standard Deviation|Mean
2782492|NCT00652028|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life (t1/2) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||hour||Standard Deviation|Mean
2782493|NCT00652028|Primary|Observed Peak Plasma Concentration|Observed peak plasma concentration (Cmax) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||picograms per milliliter||Standard Deviation|Mean
2782564|NCT00651313|Secondary|Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing||7 hours following fourth dose in 2 consecutive menstrual cycles|||||||
2782494|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞)|Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.|||picograms*hr/mL||Standard Deviation|Mean
2782495|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t)|Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.|||picograms*hr/mL||Standard Deviation|Mean
2782496|NCT00651937|Primary|Mean Symptom Severity Burden as Measured by MDASI Scores|"MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from not present (score of 0) to as bad as you can imagine (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from did not interfere (Score of 0) to interfered completely (score of 10)"|28 day course of ASCT|Intention to treat analysis, all treated participants. One participant in High Dose group did not complete adequate number of MDSAIs for analysis.|||score on a scale||Standard Deviation|Mean
2782497|NCT00651937|Primary|Mean Symptom Severity Burden as Measured by MDASI Scores|"MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive symptoms on 0 to 10 numeric scales from not present (score of 0) to as bad as you can imagine (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from did not interfere (Score of 0) to interfered completely (score of 10)."|The first 7 days post-transplant.|Intention to treat analysis, all treated participants. One participant in High Dose group did not complete adequate number of MDASI's for analysis.|||score on a scale||Standard Deviation|Mean
2782498|NCT00651924|Primary|Comprehension|Each treatment session had 5 True / False questions that corresponded with the material in the patient handbook. Phase 1 participants reviewed individual treatment modules in the patient handbook to provide immediate feedback regarding how understandable, engaging, and informative they find the materials. Phase 2 participants' used the patient materials as part of treatment and the true/false questions were used to evaluate comprehension of the materials. Example questions: Chronic pain can affect how you feel physically and emotionally (T); Relaxation is the same as being lazy and unproductive (F).|Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)|Per protocol|||Percent of questions answered correctly||Standard Deviation|Mean
2782499|NCT00651820|Secondary|Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle|Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.|9 Months|Analysis performed on Intent-to-Treat (ITT) population|||mmHg/mm|Participants|Standard Deviation|Mean
2782500|NCT00651820|Primary|Time to Complete Wound Closure Collagenase Santyl and Vehicle||21 days|Analysis was performed on all subjects as intent-to-treat (ITT).|||Days|Participants|95% Confidence Interval|Mean
2782501|NCT00651794|Secondary|Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration|Resuscitation duration is time required to complete the resuscitation. The total duration for each resuscitation was calculated from the start of the instructor's reading of the scenario to the team's statement that the infant should be transferred to the NICU. When any teaching moments occurred during the simulation, the total teaching time was subtracted from the resuscitation duration.|During the megacode, which was performed about 1 hour after the training||||seconds||Standard Deviation|Mean
2782502|NCT00651794|Secondary|Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score|We analyzed 2 measures of NRP quality: performance score and resuscitation duration. The performance score was calculated by averaging the scores (ranging from 0 to 2 - higher values represent a better outcome) for each NRP step (some of which occurred multiple times). Those scores were summed and divided by the total possible score (2 times the number of steps that should have been performed). When a step was not indicated for the specific resuscitation scenario (e.g., meconium aspiration), that step was not scored by the observers and it was not included in the denominator for performance calculation. This produced a measure of performance percentage ranging from 0 percent to 100 percent (higher values represent a better outcome) for each resuscitation.|During the megacode, which was performed about 1 hour after the training||||performance percentage||Standard Deviation|Mean
2782503|NCT00651794|Secondary|Percentage of Time Spent on Vigilance|Vigilance percentage was calculated by summing the total time the team demonstrated vigilance behavior and dividing by the total resuscitation time.|During the megacode, which was performed about 1 hour after the training||||percentage of time||Standard Deviation|Mean
2782504|NCT00651794|Secondary|Percentage of Time Spent on Workload Management|Workload management percentage was calculated by summing the total time the team demonstrated workload management behavior and dividing by the total resuscitation time.|During the megacode, which was performed about 1 hour after the training||||percentage of time||Standard Deviation|Mean
2782505|NCT00651794|Primary|Teamwork Event Rate|The teamwork event rate was calculated by summing the number of scored teamwork events (sharing information, inquiry, assertion, teaching/advising, and evaluation of plans) and dividing by the total resuscitation time (in minutes).|During the megacode, which was performed about 1 hour after the training||||teamwork events per minute||Standard Deviation|Mean
2782506|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.|||ng/mL*hr||90% Confidence Interval|Geometric Mean
2782507|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.|||ng/mL*hr||90% Confidence Interval|Geometric Mean
2782508|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 patients eligible for PK analysis, two participants were excluded from the analysis due to data issues.|||ng/mL*hr||90% Confidence Interval|Geometric Mean
2782509|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.|||ug/mL*hr||90% Confidence Interval|Geometric Mean
2782510|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.|||ug/mL*hr||90% Confidence Interval|Geometric Mean
2782511|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.|||ug/mL*hr||90% Confidence Interval|Geometric Mean
2782512|NCT00651664|Other Pre-specified|Percentage of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1|A blood sample was collected prior to alisertib dosing for the purpose of genotyping for polymorphisms in UGT1A1. The percentage of participants in the polymorphism categories: wt/wt, wt/*28, *28/*28, *28/wt, *28/other and other/other is reported. wt=wild type. *28 polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression.|Cycle 1: Pre-dose|Safety population was defined as all participants who received any amount of study drug. A blood sample was not evaluable for 3 participants and was missing for 5 participants. Data is presented for one arm because the data was collected prior to the participant receiving their assigned treatment.|||percentage of participants|||Number
2782513|NCT00651664|Secondary|Change From Baseline in Alisertib Tumor Biopsy Mitotic Index 21 Day Dosing|Tumor biopsy sections were immunoflourescently labeled with proliferative marker Ki67 and mitotic marker pHistH3. DNA was stained with a fluorescent marker as well. The Mitotic index was determined from the percentage of pHistH3 immunopositive cells within the Ki67 positive area. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Days 7 and 21, 6 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of cells||Standard Deviation|Mean
2782522|NCT00651664|Secondary|CLss/F: Apparent Oral Clearance at Steady State 21 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 14 and 21|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for CLss/F analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2782565|NCT00651313|Primary|Treatment-emgergent Adverse Events||approximately two months, based on onset of menses|||||||
2782514|NCT00651664|Secondary|Change From Baseline in Alisertib Tumor Biopsy Mitotic Index 14 Day Dosing|Tumor biopsy sections were immunoflourescently labeled with proliferative marker Ki67 and mitotic marker pHistH3. DNA was stained with a fluorescent marker as well. The Mitotic index was determined from the percentage of pHistH3 immunopositive cells within the Ki67 positive area. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Day 7, 6 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least the first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment.|||percentage of cells||Standard Deviation|Mean
2782515|NCT00651664|Secondary|Change From Baseline in Alisertib Tumor Biopsy Mitotic Index 7 Day Dosing|Tumor biopsy sections were immunoflourescently labeled with proliferative marker Ki67 and mitotic marker pHistH3. DNA was stained with a fluorescent marker as well. The Mitotic index was determined from the percentage of pHistH3 immunopositive cells within the Ki67 positive area. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Days 1 and 7, 6 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of cells||Standard Deviation|Mean
2782516|NCT00651664|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy Apoptotic Index 21 Day Dosing|Apoptotic index was defined as the mean number of apoptotic cells per mm length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µm skin sections stained with hematoxylin and eosin. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Day 1, 6 hours post-dose; Days 7 and 14, 6 and 24 hours post-dose; Day 21: 6 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||cells/mm||Standard Deviation|Mean
2782517|NCT00651664|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy Apoptotic Index 14 Day Dosing|Apoptotic index was defined as the mean number of apoptotic cells per mm length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µm skin sections stained with hematoxylin and eosin. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Day 1, 6 hours post-dose; Days 7 and 14, 6 and 24 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||cells/mm||Standard Deviation|Mean
2782518|NCT00651664|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy Apoptotic Index 7 Day Dosing|Apoptotic index was defined as the mean number of apoptotic cells per mm length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µm skin sections stained with hematoxylin and eosin. A positive change from Baseline indicates improvement.|Cycle 1: Day 1, 6 hours post-dose; Days 7 6 and 24 hours post-dose; Day 21: 6 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||cells/mm||Standard Deviation|Mean
2782519|NCT00651664|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy Mitotic Index 21 Day Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 micrometer (µm) skin sections stained with fluorescent-tagged antibodies specific to 2 mitotic markers; histone H3 phosphorylated on serine 10 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Day 7, 14 and 21, 6 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||cells/mm||Standard Deviation|Mean
2782520|NCT00651664|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy Mitotic Index 14 Day Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 micrometer (µm) skin sections stained with fluorescent-tagged antibodies specific to 2 mitotic markers; histone H3 phosphorylated on serine 10 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Day 1 and 7, 6 hours post-dose; Day 14, 6 and 24 hours post-dose|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||cells/mm||Standard Deviation|Mean
2782521|NCT00651664|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy Mitotic Index 7 Day Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 micrometer (µm) skin sections stained with fluorescent-tagged antibodies specific to 2 mitotic markers; histone H3 phosphorylated on serine 10 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Cycle 1: Pre-dose (Baseline) and Day 1, 6 hours post-dose; Day 7, 6 and 24 hours post-dose.|Pharmacodynamics Evaluable Population was defined as all participants who received at least first dose of alisertib, had a baseline skin punch biopsy sample, and had at least 1 additional skin punch biopsy taken during Cycle 1 of treatment. Here number analyzed is the number of participants with data available for analysis at the given time point.|||cells/mm||Standard Deviation|Mean
2783612|NCT00640224|Primary|Glucose Tolerance Status at Baseline and 6 Months.|Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.|Baseline and 6 months||||Participants|||Count of Participants
2782524|NCT00651664|Secondary|Accumulation Ratio (Rac) for Alisertib 21 Day Dosing|Rac for Day 7=AUCt Day 7/AUCt Day 1. Rac for Day 14=AUCt Day 7/AUCt Day 1. Rac for Day 21=AUCt Day 21/AUCt Day 1.|Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 14 and 21|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for analysis Rac. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ratio||Standard Deviation|Mean
2782525|NCT00651664|Secondary|Terminal Half-Life (t1/2) for Alisertib 21 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Day 21|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for t1/2 analysis.|||hr||Standard Deviation|Mean
2782526|NCT00651664|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib 21 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Days 14 and 21|Pharmacokinetic (PK) Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2782527|NCT00651664|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib 21 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Days 14 and 21|PK Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr||Full Range|Median
2782528|NCT00651664|Secondary|Cmax: Maximum Observed Concentration for Alisertib 21 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Days 14 and 21|PK Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM||Geometric Coefficient of Variation|Geometric Mean
2782529|NCT00651664|Secondary|CLss/F: Apparent Oral Clearance at Steady State 14 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for CLss/F analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2782530|NCT00651664|Secondary|Peak/Trough Ratio for Aliserib 14 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ratio||Standard Deviation|Mean
2782531|NCT00651664|Secondary|Accumulation Ratio (Rac) for Alisertib 14 Day Dosing|Rac for Day 7=AUCt Day 7/AUCt Day 1. Rac for Day 14=AUCt Day 7/AUCt Day 1.|Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for analysis Rac. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ratio||Standard Deviation|Mean
2782532|NCT00651664|Secondary|Terminal Half-Life (t1/2) for Alisertib 14 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data for analysis of t1/2. No data was available for analysis at Day 7.|||hr||Standard Deviation|Mean
2782533|NCT00651664|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib 14 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|Pharmacokinetic (PK) Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2782534|NCT00651664|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib 14 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|PK Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hr||Full Range|Median
2782535|NCT00651664|Secondary|Cmax: Maximum Observed Concentration for Alisertib 14 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Days 7 and 14|PK Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM||Geometric Coefficient of Variation|Geometric Mean
2782536|NCT00651664|Secondary|CLss/F: Apparent Oral Clearance at Steady State 7 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 10 hours) on Day 7|Participants from the PK Evaluable Population, all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available for CLss/F analysis.|||liter(L)/hr||Geometric Coefficient of Variation|Geometric Mean
2782667|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 16 (Follow-up)||Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2782540|NCT00651664|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib 7 Day Dosing||Cycle1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Day 7|PK Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM*hour(h)||Geometric Coefficient of Variation|Geometric Mean
2782541|NCT00651664|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib 7 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Day 7|PK Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hour(hr)||Full Range|Median
2782542|NCT00651664|Secondary|Cmax: Maximum Observed Concentration for Alisertib 7 Day Dosing||Cycle 1: Pre-dose and multiple time-points (up to 24 hour) post-dose on Day 1 and Pre-dose and multiple time-points (up to 10 hours) on Day 7|Pharmacokinetic (PK) Evaluable Population was defined as all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
2782543|NCT00651664|Primary|Maximum Tolerated Dose (MTD) of Alisertib|The MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.|Signing of the Informed Consent through 30 days following the last dose of study drug (up to 730 days)|DLT Evaluable Population was defined as all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.|||mg BID for 7 Days|||Number
2782544|NCT00651664|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|"DLT was evaluated using the National Cancer Institutes Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0; defined as any of the following events related to alisertib therapy:~Grade 4 neutropenia lasting for ≥7 consecutive days during recovery~Grade 4 neutropenia with fever and/or infection~Confirmed platelet count <25,000/mm^3~≥Grade 3 nausea and/or emesis despite the use of an antiemetic prophylaxis~≥Grade 3 diarrhea that occurred despite therapy with loperamide~Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (< 1 week) Grade 3 fatigue~Treatment delay of >1 week because of a failure of adequate hematologic or nonhematologic recovery from the previous cycle of treatment.~Other alisertib-related nonhematologic toxicities ≥ Grade 2 that, in the opinion of the investigator, required a dose reduction or discontinuation of therapy with alisertib."|First dose through 30 days following the last dose of study drug (up to 730 days)|DLT Evaluable Population was defined as all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.|||participants|||Number
2782545|NCT00651625|Secondary|Physician Satisfaction|"0- 10 cm visual analogue satisfaction scale (VASS)~0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure"|during procedure||||cm||Standard Deviation|Mean
2782546|NCT00651625|Secondary|Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation)||during procedure, 2 weeks afterwards, and 6 months afterwards||||participants|||Number
2782547|NCT00651625|Secondary|Aspirated Fluid Volume|Aspirated fluid volume during procedure|during procedure||||ml||Standard Deviation|Mean
2782548|NCT00651625|Primary|Pain Using VAS (Visual Analogue Pain Scale)|0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.|2 weeks||||cm||Standard Deviation|Mean
2782549|NCT00651573|Secondary|Postoperative Atrial Fibrillation||After surgery until hospital discharge||||Participants|||Count of Participants
2782550|NCT00651573|Secondary|Prolonged Postoperative Ventilation|On ventilation >24 hours after surgery|After surgeyr until hospital discharge||||Participants|||Count of Participants
2782551|NCT00651573|Secondary|Number of Blood Transfusion||From induction to the end of sugery||||times||Inter-Quartile Range|Median
2782552|NCT00651573|Secondary|Length of Hospital Stay||After surgery until hospital discharge||||days||Inter-Quartile Range|Median
2782553|NCT00651573|Secondary|Length of ICU Stays||After surgery until discharged from ICU||||hours||Inter-Quartile Range|Median
2782554|NCT00651573|Primary|A Composite of In-hospital Postoperative Morbidity and Mortality|The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).|After surgery until hosptal discharge||||Participants|||Count of Participants
2782555|NCT00651482|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) per RECIST criteria|24 months||||months||Full Range|Median
2782556|NCT00651482|Secondary|Treatment Discontinuation Due to Disease Progression|Number of subjects whose treatment was discontinued due to disease progression|24 months||||participants|||Number
2782557|NCT00651482|Secondary|Treatment Discontinuation Due to Toxicity|Number of subjects whose treatment was discontinued due to toxicity|24 months||||participants|||Number
2782558|NCT00651482|Secondary|Total Number of Drug-related SAEs||24 months||||events|||Number
2782559|NCT00651482|Secondary|Number of Subjects With Drug-related SAEs||24 months||||participants|||Number
2782560|NCT00651482|Secondary|Overall Survival (OS)||44 months||||months||Full Range|Median
2782561|NCT00651482|Secondary|Time-to-Treatment Failure (TTF)||24 months||||months||Full Range|Median
2782566|NCT00651313|Primary|The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.||Two 4-day dosing regimens for two consecutive monthy menstrual cycles|Time-weighted average pain intensity over the 4 treatment days using the 4 point categorical scale - none (0), mild (1), moderate (2), and severe (3); primary efficacy variable. ITT Analysis Set.|||units on a scale||Standard Deviation|Mean
2782567|NCT00651261|Secondary|DFS Rate One Year After Completing the Planned Continuation Phase||30 months|||||||
2782568|NCT00651261|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR.|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
2782569|NCT00651261|Secondary|Complete Response Rate|Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60.|Induction therapy (up to 60 days)||||percentage of participants||95% Confidence Interval|Number
2782570|NCT00651261|Secondary|Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant|Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
2782571|NCT00651261|Secondary|Event- Free Survival|"Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.~Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint."|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
2782572|NCT00651261|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)||||months||95% Confidence Interval|Median
2782573|NCT00651183|Primary|Change From Baseline in UPDRS Part III (Motor Examination)|14 components rating scale with 27 items scored by 0 (none) - 4 (severe)|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
2782574|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
2782575|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
2782576|NCT00651183|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)|"Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.~Total UPDRS part I score ranges from 0 = best score to 16 = worst score"|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis|||Points on a scale||Inter-Quartile Range|Median
2782577|NCT00651157|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to documentation of disease progression, assessed up to 5 years||||days||95% Confidence Interval|Median
2782578|NCT00651157|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2782579|NCT00651157|Primary|Tumor Response|"A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Every 4 weeks after 4 courses of treatment, assessed up to 5 years||||participants|||Number
2782580|NCT00651118|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|"adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.~The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result."|day 1 to day 14|intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2782581|NCT00651118|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result."|day 1 to day 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2782582|NCT00651118|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result."|days 1 to 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
2782583|NCT00651040|Secondary|Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures||1 year||2016-12-31|12/2016||||
2782584|NCT00651040|Primary|The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.|The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.|1 year||||mg/kg||Standard Deviation|Mean
2782585|NCT00650936|Primary|Co-Primary Safety Endpoint|The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event|24 months|The analysis population for the co-primary safety endpoint is all subjects who either reached their two-year visit or had a device or delivery system related adverse event prior to their 2-year visit.|||percentage of participants||95% Confidence Interval|Number
2782586|NCT00650936|Primary|Co-Primary Effectiveness Endpoint|"The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met:~Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair"|24 months|The analysis population for the co-primary effectiveness endpoint was all subjects who either reached their two-year visit or demonstrated closure of the atrial septal defect prior to or at their 2-year visit.|||percentage of participants||95% Confidence Interval|Number
2782587|NCT00650936|Primary|Percent of Subjects With Two-year Device-related Hemodynamic Compromise|The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.|24 months|The analysis population for the primary efficacy endpoint was all subjects who either reached their two-year visit or had a device-related hemodynamic compromise event.|||percentage of participants||95% Confidence Interval|Number
2782588|NCT00650858|Secondary|180 Day Follow-Up Glasgow Outcome Scale (GOS) Score|"180 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|180 days||||GOS score||Full Range|Median
2782589|NCT00650858|Secondary|180 Day Follow-Up Modified Rankin Scale (mRS) Score|"180 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|180 days||||mRS score||Full Range|Median
2782590|NCT00650858|Secondary|90 Day Follow-Up Glasgow Outcome Scale (GOS) Score|"90 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|90 days||||GOS score||Full Range|Median
2782591|NCT00650858|Secondary|90 Day Follow-Up Modified Rankin Scale (mRS) Score|"90 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)"|90 days||||mRS score||Full Range|Median
2782592|NCT00650858|Secondary|Average Daily Percentage Clot Size Resolution Over the First 3 Days|Daily IVH clot volume resolution, as a percentage of stability CT IVH volume, averaged over the first 3 days, determined by CT scans|3 days||||Percent of stability CT volume resolved||Full Range|Mean
2782593|NCT00650858|Primary|Rate of Symptomatic Bleeding Events|The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.|30-days||||participants|||Number
2782594|NCT00650858|Primary|Incidence of Bacterial Ventriculitis, Meningitis|The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.|30 days||||Number of participants|||Number
2782595|NCT00650858|Primary|30-day Mortality|The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.|30 days||||Number of participants|||Number
2782668|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 12||Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2782596|NCT00650845|Secondary|eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population|eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and a post- procedure blood sample for creatinine measurements) deprived of patients with protocol deviations/violations.|||Percentage of change from baseline||Standard Deviation|Mean
2782597|NCT00650845|Secondary|Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population|eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and a post-procedure blood sample for creatinine measurements.|||Percentage of change from baseline||Standard Deviation|Mean
2782598|NCT00650845|Secondary|Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Per protocol population. This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.|||Percentage of change from baseline||Standard Deviation|Mean
2782599|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.|||Number of patients|||Number
2782600|NCT00650845|Secondary|Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Full analysis set population:all included patients with a pre and post-procedure blood sample for creatinine measurement.|||Percentage of change from baseline||Standard Deviation|Mean
2782601|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and post-procedure blood sample for creatinine measures.|||Number of patients|||Number
2782602|NCT00650806|Secondary|Change in Waist/Hip Ratio From Baseline to Week 12|The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||ratio||Standard Deviation|Mean
2782603|NCT00650806|Secondary|Change in Hip Circumference From Baseline to Week 12|The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||cm||Standard Deviation|Mean
2782604|NCT00650806|Secondary|Change in Waist Circumference From Baseline to Week 12|The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||cm||Standard Deviation|Mean
2782605|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2782669|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 8||Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2782670|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 4||Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2782606|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
2782607|NCT00650806|Secondary|Change in Body Mass Index (BMI) From Baseline to Week 12|The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||kg/m2||Standard Deviation|Mean
2782608|NCT00650806|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||kg||Standard Deviation|Mean
2782609|NCT00650806|Primary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Deviation|Mean
2782610|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782611|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782612|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782613|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782671|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 2||Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2783613|NCT00640224|Primary|Hepatic Insulin Sensitivity at Baseline and 6 Months.|Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.|Baseline and 6 months||||(mg/kg/min x uU/mL)-1||Standard Error|Mean
2782614|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782615|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782616|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782617|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782618|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782619|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782620|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782672|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 1||Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2782673|NCT00650767|Secondary|C-Reactive Protein (CRP) at Baseline||Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||mg/dL||Standard Deviation|Mean
2782621|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782622|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782623|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782624|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782625|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782626|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782627|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782628|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782629|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782701|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782630|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782631|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782632|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782633|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782634|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782635|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782636|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782637|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782638|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782742|NCT00650546|Primary|Change in NAS|The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.|Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.||||units on a scale||Standard Deviation|Mean
2786603|NCT00618072|Secondary|Diastolic BP|Blood pressure was assessed using NCEP guidelines.|6 months||||mmHg||Standard Error|Mean
2782639|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782640|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782641|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782642|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782643|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782644|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782645|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782646|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782647|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782780|NCT00649389|Secondary|Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks||Baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of seated diastolic blood pressure|||Percentage of subjects|||Number
2782648|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782649|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782650|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782651|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782652|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782653|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782654|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782655|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782656|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782781|NCT00649389|Primary|Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).||baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of SeDBP|||mm Hg||Standard Deviation|Mean
2786604|NCT00618072|Secondary|Systolic BP|Blood pressure was assessed using NCEP guidelines.|6 months||||mmHg||Standard Error|Mean
2782657|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782658|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782659|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782660|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782661|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782662|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782663|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782664|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782665|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782666|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2786605|NCT00618072|Secondary|Waist Circumference||6 months||||cm||Standard Error|Mean
2782674|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782675|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782676|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782677|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782678|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782679|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782689|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782680|NCT00650767|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782681|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782682|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782683|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782684|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782685|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782686|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782687|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782688|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782690|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782691|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782692|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782693|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782694|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782695|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782696|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782697|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782698|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782699|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782700|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782702|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782703|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782704|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782705|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782706|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782707|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782708|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782709|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782710|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782711|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782793|NCT00648908|Secondary|Timed 25 Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data|||feet/second||Standard Deviation|Mean
2783382|NCT00641147|Secondary|Change in Ornithine Decarboxylase (ODC) Activity Levels|Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)|Baseline and 8 months||||nmol/mg/hr||Standard Deviation|Mean
2782712|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782713|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782714|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782715|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2782716|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782717|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782718|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782719|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782720|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782721|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782804|NCT00648648|Primary|Plasma Concentration of MK-1775 at 8 Hours After Administration (C8hr) of Single or Multiple Oral Doses|MK-1775 was measured in the plasma at 8 hours after dosing (Day 1 for single dose of monotherapy, Day 2 of single-dose combination therapy and QD x 2 Combination dosing, and Day 3 dose for BID X 2.5 combination dosing) for participants with available data.|8 hours after MK-1775 dose|All treated participants with available C8hr data.|||nM||Standard Deviation|Mean
2782722|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782723|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782724|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782725|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782726|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782727|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782728|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782729|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782730|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782731|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782872|NCT00646776|Secondary|Cmin of ATV|Cmin was derived from the plasma concentration versus time for ATV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782732|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.|||percentage of participants||95% Confidence Interval|Number
2782733|NCT00650767|Primary|American College of Rheumatology 20% (ACR20) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.|||percentage of participants||95% Confidence Interval|Number
2782734|NCT00650585|Primary|Self-reported Lifetime Inhalant Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782735|NCT00650585|Primary|Self-reported Lifetime Marijuana Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782736|NCT00650585|Primary|Self-reported Lifetime Cigarette Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782737|NCT00650585|Primary|Self-reported Lifetime Alcohol Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782738|NCT00650585|Primary|Self-reported 30-day Inhalant Use|"Students completed an 81-item self-report questionnaire. They were asked on how many days they had used inhalants in the previous 30 days. Response options included none, 1 or 2 days in the last month, 3 to 5 days in the last month, 6 to 19 days in the last month, and 20 or more days in the last month. Response options were dichotomized into none and at least one day."|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782739|NCT00650585|Primary|Self-reported 30-day Marijuana Use|"Students completed an 81-item self-report questionnaire. They were asked on how many days they had used marijuana in the previous 30 days. Response options included none, 1 or 2 days in the last month, 3 to 5 days in the last month, 6 to 19 days in the last month, and 20 or more days in the last month. Response options were dichotomized into none and at least one day."|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782740|NCT00650585|Primary|Self-reported 30-day Use of Cigarettes|"Students completed an 81-item self-report questionnaire. They were asked on how many days they had smoked cigarettes in the previous 30 days. Response options included none, 1 or 2 days in the last month, 3 to 5 days in the last month, 6 to 19 days in the last month, and 20 or more days in the last month. Response options were dichotomized into none and at least one day."|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||participants|||Number
2782741|NCT00650585|Primary|Self-reported 30-day Use of Alcohol|"Students completed an 81-item self-report questionnaire. They were asked on how many days they had used alcohol in the previous 30 days. Response options included none, 1 or 2 days in the last month, 3 to 5 days in the last month, 6 to 19 days in the last month, and 20 or more days in the last month. Response options were dichotomized into none and at least one day."|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.|||Participants|||Number
2786606|NCT00618072|Secondary|HOMA-IR|HOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5.|6 months||||HOMA-IR score||Standard Error|Mean
2782743|NCT00650546|Primary|Number of Patients With Improvement in Liver Histology After Treatment With Exenatide|Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS<3.|between baseline and 24-28 weeks after initiating treatment||||participants|||Number
2782744|NCT00650260|Primary|Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius|Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C|Upon entry to the post anesthesia care unit||||Percentage of participants|||Number
2782745|NCT00650260|Primary|Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.||Temp taken just prior to surgery|Per protocol, sample size calculations indicate that a total sample size of 42 patients will be necessary to evaluate the primary outcome at an adjusted alpha = 0.05 with 80% power.|||Percentage of participants|||Number
2782746|NCT00650260|Secondary|Median Post Anesthesia Care Unit Sublingual Temperature||Upon arrival to the post anesthesia care unit||||Degrees Celcius||Full Range|Median
2782747|NCT00650260|Secondary|Average Intraoperative Esophageal Temperature|Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.|Intraoperative 0-70 minutes||||Degrees Celcius||Full Range|Mean
2782748|NCT00650260|Secondary|Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.|Average core body temperature measured with an esophageal probe at 60 minutes post-induction|60 minutes post anesthesia induction||||degrees celcius||Standard Deviation|Mean
2782749|NCT00650260|Primary|Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius||Intraoperative Period||||percentage of participants|||Number
2782750|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."|||participants|||Number
2782751|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Responder Population. Various n values are the result of participant attrition."|||participants|||Number
2782752|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."|||participants|||Number
2782753|NCT00650104|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."|||points on a scale||Standard Deviation|Mean
2782754|NCT00650104|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Responder Population. Various n values are the result of participant attrition."|||points on a scale||Standard Deviation|Mean
2782755|NCT00650104|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."|||points on a scale||Standard Deviation|Mean
2782794|NCT00648908|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 5 years|Safety Population. No imputation for missing data|||Participants|||Number
2782756|NCT00650104|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Maintained Responder : subset of the Responder Population, which was maintained or further decreased for a minimum of 4 weeks whilst the participant received a stable or decreasing dose of study medication. Various “n” values are the result of participant attrition.|||points on a scale||Standard Deviation|Mean
2782757|NCT00650104|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Responder: a subset of the ITT Population containing those participants who had a score of 1 (very much improved) or 2 (much improved) on the clinical global impression (CGI) scale during the study. CGI-I scores (1 to 7 [very much worse]) the participant’s condition relative to baseline. Various “n” values are the result of participant attrition.|||points on a scale||Standard Deviation|Mean
2782758|NCT00650104|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|Every study visit from baseline to market availability (Month 78)|"All participants who received at least one dose of study medication. The treatment-emergent Study 196 AEs were defined as occurring during initial titration or long-term treatment or follow up."|||participants|||Number
2782759|NCT00650104|Primary|Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one treatment period evaluation for any parameter were included in the evaluation of the therapeutic benefit. Various “n” values are the result of participant attrition.|||points on a scale||Standard Deviation|Mean
2782760|NCT00650091|Post-Hoc|Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters)|Baseline, 15, 30, 45, 60 week|Analysis population includes participants from the amended study design only.|||liters||Standard Deviation|Mean
2782761|NCT00650091|Secondary|Number of Participants With Maintained Forced Vital Capacity Response|Maintained forced vital capacity response was a binary variable taking on a value of 1 for participants with higher FVC % predicted at week 60 compared to baseline.|Measured at Week 60|Analysis population includes participants from the amended study design only.|||participants|||Number
2782762|NCT00650091|Secondary|Respiratory Infections||Measured at Week 60|Analysis population includes participants from the amended study design only.|||events|||Number
2782763|NCT00650091|Secondary|Acute Exacerbations|"The following 3 criteria will define acute exacerbations in subjects with acute worsening of their respiratory conditions:~1. Clinical (all of the following required): A) Unexplained worsening of dyspnea or cough within 30 days, triggering unscheduled medical care (e.g., emergency room, clinic, study visit, hospitalization). B) No clinical suspicion or overt evidence of cardiac event, pulmonary embolism, or deep venous thrombosis to explain acute worsening of dyspnea. C) No pneumothorax."|Measured at Week 60|Analysis population includes participants from the amended study design only.|||events|||Number
2782764|NCT00650091|Secondary|Disease Progression|"The time-to-death or a 10% decline in FVC will be defined as the time-to-disease progression.~The 10% decline in FVC from enrollment must be confirmed on 2 consecutive visits no less than 6 weeks apart. For subjects with 2 consecutive visits with a 10% decline in FVC, the time-to-disease progression will be defined as the time interval between enrollment and the initial visit with a 10% FVC decline."|Measured at Week 60|Analysis population includes participants from the amended study design only.|||percentage of participants||95% Confidence Interval|Number
2782765|NCT00650091|Primary|Overall Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)|Measured as the estimated change from baseline to Week 60|Analysis population includes participants from the amended study design only.|||liters||95% Confidence Interval|Mean
2782795|NCT00648895|Primary|Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).|Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).|Before treatment and after 10 weeks|Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.|||Percentage||Standard Deviation|Mean
2782766|NCT00650078|Secondary|Relative Reduction of Morning Stiffness|Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. Excludes those participants with missing data. Analysis used last observation carried forward imputation.|||Relative Change from Baseline (%)||95% Confidence Interval|Median
2782767|NCT00650078|Primary|ACR 20 Response Rate at Visit 4|"Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:~> 20% reduction in the tender joint count (0-28)~> 20% reduction in the swollen joint count (0-28)~> 20% reduction in 3 out of the 5 following additional measures:~Patient's assessment of pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~Functional Disability Index of the Health Assessment Questionnaire~C-reactive protein or erythrocyte sedimentation rate"|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. All missing values were imputed as non-responders.|||participants|||Number
2782768|NCT00649961|Primary|To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.||6 months||||pg/ml||Full Range|Median
2782769|NCT00649792|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 40 months|Safety Population. No imputation for missing data|||participants|||Number
2782770|NCT00649792|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)|The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)|ITT Population. No imputation for missing data|||0-10 rating scale||Standard Deviation|Mean
2782771|NCT00649792|Secondary|Clinician's Global Impression (CGI)|The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.|Visit 1 and every clinic visit thereafter|ITT Population. No imputation for missing data|||1-7 scale rating||Standard Deviation|Mean
2782772|NCT00649792|Secondary|Subject Global Impression (SGI)|For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.|Visit 1 and every clinic visit thereafter (other than the follow-up visit)|ITT Population. No imputation for missing data|||1-7 scale rating||Standard Deviation|Mean
2782773|NCT00649792|Secondary|Timed 25-Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data|||feet/seconds||Standard Deviation|Mean
2782774|NCT00649428|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782775|NCT00649428|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782776|NCT00649428|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782777|NCT00649428|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.|||participants|||Number
2782778|NCT00649389|Secondary|Change in Seated Systolic Blood Pressure From Baseline to Week 12||Baseline to week 12||||mm Hg||Standard Deviation|Mean
2782779|NCT00649389|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination||Baseline to 12 weeks or early termination|The ABPM Analysis Set included 440 subjects who provided consent to participate in the ABPM sub-study and who were to provide ABPM measurements prior to and after randomization. Those analyzed is the number who had values at both baseline and 12 weeks or early termination|||mm Hg||Standard Deviation|Mean
2782995|NCT00644969|Secondary|Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS; (n)=number of participants with evaluable data at observation.|||cigarettes per day||95% Confidence Interval|Least Squares Mean
2782782|NCT00649220|Secondary|Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.|"VAS is a report device to measure the subject's burden caused by behavioral symptoms. To measure the burden on the VAS only the first 3 items of the Neuropsychiatric Inventory (NPI) Questionnaire were considered (delusions, hallucinations (visual and auditory), and agitation / aggression). The VAS consists of a 100 mm horizontal line, anchored at the ends with the reference not at all and extremely. The VAS score was determined by measuring in mm from the left hand end of the line to the point, where the investigator had marked the magnitude of a subject's burden."|Week 8-20 post Baseline|"Intention to treat (ITT).~Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"|||Units on a scale [cm]||Standard Deviation|Mean
2782783|NCT00649220|Secondary|Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20|"NOSGER is a comprehensive scale, which contains 30 items of behavior, each rated on a 5-point scale according to the frequency of occurrence by direct observation. Item scores are summarized into 6 dimension scores: memory, instrumental activities of daily life, self-care, mood, social behavior, and disturbing behavior. The NOSGER has a scoring range of 30 to 150 with the higher scores indicating worse subject's status. The items in each group are rated for their frequency ranging from 1 (never) to 5 (always).~A change of <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"|||Units on a scale||Standard Deviation|Mean
2782784|NCT00649220|Secondary|Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.|"The modified ADCS-ADL19 is comprehensive battery of ADL questions aimed to measure the functional ability of subjects with Dementia of Alzheimer's type over a broad range of dementia severity. It has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. Each ADL item was rated from the highest level of independent performance to complete loss.~Change of >0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"|||Units on a Scale||Standard Deviation|Mean
2782785|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The second part consists of a proxy rating and a self-assessment rating. The scoring range of each rating is 1 to 10. The maximum total score of 10 corresponds to severe depression.~A change <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"|||units on a scale||Standard Deviation|Mean
2782786|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The first part consists of 9 items, which assess different symptoms associated with dementia such as memory, time-orientation, etc. The scoring range is 0 to 50 points. A score of 35 or lower is an indication of dementia.~A change >0 represents an improvement."|Week 4-20 post baseline|"Intent to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"|||units on a scale||Standard Deviation|Mean
2782787|NCT00649220|Secondary|Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.|MMSE is a brief, physician-administered scale, designed for measuring the cognitive functions, such as: orientation, memory, attention, naming, and comprehension. The scoring range of MMSE is 0 to 30 points. A score of 23 or lower is indicative of cognitive impairment. Change of >0 reveals an improvement compared to baseline.|Week 20 post baseline|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
2782788|NCT00649220|Secondary|Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.|See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline.|Week 8-20 post Baseline|"Intention to treat (ITT).~Week 8: n=16; Week 12: n=14; Week 16: n=13; Week 20: n=15"|||Percent of daily dose [DDD]||Standard Deviation|Mean
2782789|NCT00649220|Primary|Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.|"VAS: see #8. Mean percent of the total Defined Daily Dose (DDD), averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ [percent] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline."|Week 8-20 post baseline|Intention to treat (ITT)|||Percent of daily dose [DDD]||Standard Deviation|Mean
2782790|NCT00648908|Secondary|Expanded Disability Status Scale (EDSS)|"Each patient, based on their baseline neurological exam, are scored according to the EDSS~The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable."|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
2782791|NCT00648908|Secondary|Clinician Global Impression of Change (CGIC)|"Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.~The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse."|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
2782792|NCT00648908|Secondary|Subject Global Impression (SGI)|"Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).~For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted."|visit 1 and every clinic visit|ITT Population. No imputation for missing data|||units on a scale||Standard Deviation|Mean
2782796|NCT00648739|Secondary|Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab|"Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy.~The number of participants with the individual best response and ORR for each cohort is presented."|From first dose through 10 weeks after the last dose|All participants with MM who received at least 1 dose of samalizumab.|||Participants|||Count of Participants
2782797|NCT00648739|Secondary|Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate|Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=>50% increase for >2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.|From first dose through 10 weeks after the last dose|All participants with B-CLL who received at least 1 dose of samalizumab.|||Participants|||Count of Participants
2782798|NCT00648739|Secondary|Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose)|"Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as unevaluable and an analysis was not performed."|Baseline (Predose) and Day 1 (Postdose)|All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m^2 dose level.|||mean channel fluorescent intensity||Full Range|Median
2782799|NCT00648739|Secondary|Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)|"Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as unevaluable and an analysis was not performed."|Baseline (Predose) and Day 1 (Postdose)|All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m^2 dose level.|||percentage of B-CLL cells bound||Full Range|Median
2782800|NCT00648739|Primary|Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|From first dose through 10 weeks after the last dose|All participants who received at least 1 dose of samalizumab.|||participants|||Number
2782801|NCT00648739|Primary|Maximum Tolerated Dose (MTD) Of Samalizumab|"The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT.~A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions."|From first dose through 10 weeks after the last dose|All participants who received at least 1 dose of samalizumab.|||mg/m^2|||Number
2782802|NCT00648648|Secondary|Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Best overall response achieved by a participant. Starting at Day 1, participants in Part 2 were evaluated for tumor response every 6-8 weeks until discontinuation from study treatment according to RECIST criteria; which are based on radiographic imaging. Recorded responses were either confirmed by Central Review or unconfirmed (Investigator assessment only), and included complete response (CR; defined as disappearance of all target lesions), partial response (PR; at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD), stable disease (SD; neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD, taking as reference the smallest sum LD since the treatment started), or progressive disease (PD; ≥20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions).|From Day 1 up through discontinuation of study treatment (up to ~11.2 months)|All treated participants in Part 2 with measurable disease at baseline per RECIST criteria. Participants who were originally treated in Part 1 and continued in Part 2 were included in their respective Part 2 arms. Participants who could not be evaluated after treatment are categorized as “not evaluable (NE).|||Participants|||Count of Participants
2782803|NCT00648648|Primary|Mean Urine Excretion of MK-1775 24 Hours After the Day 1 Monotherapy Dose|The mean cumulative amount of MK-1775 excreted unchanged in urine after a single oral dose was measured during the initial monotherapy cycle of the study. For this outcome measure, samples were collected and analyzed only for the MK-1775 monotherapy arms of the study at defined intervals after the Day 1 dose of monotherapy. Part 2 MK-1775 combination arms were not sampled per protocol.|At 0-4 hours, 4-8 hours, and 12-24 hours post Day 1 dose of monotherapy|All treated Part 1 participants with available urine sample data.|||mg||Standard Deviation|Mean
2782805|NCT00648648|Primary|Percentage of Total pCDC2 in Skin Cells at Baseline and 48 Hours After MK-1775 Dosing|The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and at 48 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 (150 mg, 200 mg, 250) BID x 2.5 Multi Dose plus cisplatin 75 mg/m^2 groups and the 325 mg BID x2.5 Multi Dose + Carboplatin group with available data per protocol.|Baseline, 48 hours after first MK-1775 dose|All participants in Part 2-B/3 MK-1775 (150 mg, 200 mg, 250) BID x 2.5 Multi Dose plus cisplatin 75 mg/m^2 groups and 325 mg BID x2.5 Multi Dose + carboplatin group who received ≥1 dose of study treatment and had evaluable CDC2 data at 48 hours post dose. Per protocol, Part 1, Part 2-A, and remaining Part 2-B/3 groups did not have data reported.|||percentage of cells||90% Confidence Interval|Geometric Least Squares Mean
2782806|NCT00648648|Primary|Percentage of Total pCDC2 in Skin Cells at Baseline and 24 Hours After MK-1775 Dosing|The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and 24 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 QD x2 Multi Dose plus Gemcitabine treatment groups with available data per protocol.|Baseline, 24 hours after first MK-1775 dose|All participants in the Part 2-B/3 MK-1775 QD x2 Multi Dose plus Gemcitabine treatment groups who received at least one dose of study treatment and had evaluable CDC2 data at 24 hours post dosing. Per protocol, the Part 1, Part 2-A, and Part 2-B/3 MK-1775 BID treatment groups did not have data reported for this time point.|||percentage of cells||90% Confidence Interval|Geometric Least Squares Mean
2782807|NCT00648648|Primary|Percentage of Total Cyclin-dependent Kinase (CDC2)-Positive Cells That Were Phosphorylated (pCDC2) in Skin Cells at Baseline and 8 Hours After MK-1775 Dosing|The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total CDC2-positive cells that were pCDC2 positive (% pCDC2-positive cells) at baseline and 8 hours after MK-1775 dosing were reported for participants in Part 1, 2-A, and 2-B/3 treatment groups with available data per protocol.|Baseline, 8 hours after first MK-1775 dose|Participants in Parts 1, 2-A, and 2-B/3 with ≥1 dose treatment and evaluable CDC2 data at 8 hours post dosing. Per protocol the MK-1775 QD x2.5 Multi Dose + Gemcitabine groups, MK-1775 150, 200, and 250 mg BID x 2.5 Multi Dose + cisplatin 75 mg/m^2 groups, and MK-1775 325 mg BID x 2.5 Multi Dose + carboplatin AUC 5 group did not have data reported|||percentage of cells||90% Confidence Interval|Geometric Least Squares Mean
2782808|NCT00648648|Primary|Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)|DLTs were adverse events (AEs) considered at least possibly related to study drug that prevented escalation of the drug dose. Hematologic DLTs were any grade (Gr) 4-5 toxicity EXCEPT: Gr 4 anemia and Gr 4 leukopenia, Gr 4 neutropenia lasting for <7 days, Gr 4 thrombocytopenia lasting for <4 days except if a platelet transfusion is required, and Gr 3/Gr 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic DLT was defined as any Gr 3, 4, or 5 non-hematologic toxicity EXCEPT: nausea, vomiting, diarrhea, or dehydration (all Gr 3) occurring in a setting of inadequate compliance with supportive care measures and lasting for <48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, and clinically non-significant, treatable or reversible lab abnormalities including liver function tests, uric acid, etc.|Part 1: Up to 14 days, Part 2: Up to 28 days|All participants who received at least one dose of study treatment and were evaluable for DLT.|||Participants|||Count of Participants
2782809|NCT00648375|Secondary|Change in Brief Symptoms Inventory-Short Form (BSI-SF)|BSI-SF is an 18 item scale used for a global score of general distress. Scores range from 0-72, higher scores represent more severe symptoms|Measured at Weeks 0,2,4,6,8,10,12, 14|3 subjects were randomized, one to propranolol and one to placebo. The total number of subjects was too low to perform statistical analysis.|||score on a scale||Full Range|Mean
2782810|NCT00648375|Secondary|Change in Post-traumatic Scale-Self Score (PS-SR)|This is a 17-item self-report scale. Scores range from 0-51, higher scores represent more severe symptoms.|Measured at Weeks 0,2,4,6,8,10,12, 14|3 subject were enrolled: 1 was randomized to propranolol and 2 were randomized to placebo.|||score on a scale||Full Range|Mean
2782811|NCT00648375|Secondary|Change in Depression Measured by Beck Depression Inventory (BDI)|Scores range from 0-30, higher scores represent more severe symptoms|Measured at Weeks 0,2,4,6,8,10,12, 14|3 subjects were enrolled and randomized: one to active propranolol and two to placebo. Total number of subjects was too low to perform statistical analysis|||score on a scale||Full Range|Mean
2782812|NCT00648375|Primary|Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)|Scores range from 0-70, higher scores represent more severe symptoms|Measured at Week 0, 2,4,6,8,10,12,14|3 subjects enrolled in the study and completed all study visits.|||score on a scale||Full Range|Mean
2782813|NCT00648167|Primary|The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)||28 days||||mg/dL||Standard Deviation|Mean
2782814|NCT00648115|Secondary|Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)|overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration|12 months||||dollars||Standard Deviation|Mean
2782815|NCT00648115|Primary|Time Till Employment in Days|Number of days until first day of competitive employment|12 months||||number of days to first employment||95% Confidence Interval|Mean
2782816|NCT00648037|Primary|Safety of Rituximab Prophylaxis|The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.|3 months post transplant|Please see Adverse Event section for more details.|||participants|||Number
2782817|NCT00647998|Secondary|Hemoglobin||24 hours post-surgery||||gm/dL||Standard Deviation|Mean
2782818|NCT00647998|Secondary|CSF S100beta|Cerebrospinal fluid S100beta level|48 hours||||pg/mL||Inter-Quartile Range|Median
2782873|NCT00646776|Secondary|Cmax of ATV|Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782819|NCT00647998|Primary|Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor Score <25|The NIHSS is a validated quasi-ordinal measure of stroke severity. An NIHSS >4 is generally considered moderate or severe. The ASIA Lower Extremity Motor Score is a cumulative total of assessments of strength in 5 muscles in each leg, using the Medical Research Council 0-5 stroke score. ASIA score < 25 is associated with impaired ambulation.|Discharge from the hospital||||Participants|||Count of Participants
2782820|NCT00647699|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months|The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.|||diopters||Standard Deviation|Mean
2782821|NCT00647556|Secondary|Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24|Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (~90%) Response, 2 = Marked (~75%) Response, 3 = Moderate (~50%) Response, 4 = Slight (~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2782822|NCT00647556|Secondary|Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24|Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (~90%) Improvement, 2 = Marked (~75%) Improvement, 3 = Moderate (~50%) Improvement, 4 = Slight (~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)|||participants|||Number
2782823|NCT00647556|Secondary|Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.|Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 12|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2782824|NCT00647556|Secondary|Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24|Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|baseline, week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2782825|NCT00647556|Primary|Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24|Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
2782826|NCT00647426|Secondary|The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity|Monitored at designated timepoints.All patients will be evaluable for toxicity from the time of their first treatment with SORAFENIB.|30 months|Sufficient data was not collected.||||||
2782827|NCT00647426|Secondary|Number of Participants With Serious Adverse Events|"Assessment of adverse events related to the combination infusion, These include a Serious Adverse Event (SAE) is an adverse event occurring at any dose that results in any of the following outcomes:~Death~Life-threatening~Persistent or significant disability/incapacity~In patient hospitalization or prolongation of existing hospitalization~Congenital anomaly/birth defect or • blood dyscrasia without inpatient hospitalization~convulsions without inpatient hospitalization~intensive treatment in an emergency room or at home for allergic bronchospasm without inpatient hospitalization~development of drug dependency~drug abuse~overdose with an associated serious event, or required intervention to prevent impairment/damage"|30 months|Sufficient data was not collected.||||||
2782828|NCT00647426|Secondary|Number of Participants the Progression-free Survival (PFS) .|Disease progression is based on RECIST documentation. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions|30 months|Sufficient data was not collected.||||||
2782829|NCT00647426|Primary|The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin|"The response rate from the combination therapy of Sorafenib and Docetaxel/carboplatin for patients with Stage IIIB/IV NSCLC.The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria (see section 9.3.1).Tumor Response: Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): a) At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): a) At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|30 months|Sufficient data was not collected.||||||
2782996|NCT00644969|Secondary|Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS|||participants|||Number
2782830|NCT00647400|Secondary|Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.|||Participants|||Number
2782831|NCT00647400|Secondary|Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.|||Participants|||Number
2782832|NCT00647400|Primary|Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.|||Participants|||Number
2782833|NCT00647348|Secondary|Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Psychological Score)|"The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 not at all to 5extremely. Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates a greater impact of the disease on daily function (worse health)."|24 months||||score on a scale||Standard Deviation|Mean
2782834|NCT00647348|Secondary|Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Physical Score)|"The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 not at all to 5extremely. Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health)."|24 months||||score on a scale||Standard Deviation|Mean
2782835|NCT00647348|Secondary|Disease Impact Specific to the Disease and Rated by the Patient (MSIS-29 Questionnaire Total Score)|"The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 not at all to 5extremely. Each of the two scales is scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates a greater impact of the disease on daily function (worse health)."|24 months||||score on a scale||Standard Deviation|Mean
2782836|NCT00647348|Secondary|Evaluation of Disability (MSFC PASAT).|The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. Shorter inter-stimulus intervals, e.g., 2 seconds or less have also been used with the PASAT but tend to increase the difficulty of the task. Score 0 to 60, higher score less disability.|24 months||||score on a scale||Standard Deviation|Mean
2782837|NCT00647348|Secondary|Evaluation of Disability (MSFC Peg Test).|The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded.|24 months||||speed per second||Standard Deviation|Mean
2782838|NCT00647348|Secondary|Evaluation of Disability (MSFC Walk).|The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark.|24 months||||foot per second||Standard Deviation|Mean
2782839|NCT00647348|Secondary|Evaluation of Disability (MSFC Z Score).|Negative value implies worsening and a positive value implies improvement.|24 months||||score on a scale||Standard Deviation|Mean
2782840|NCT00647348|Secondary|Evaluation of Disability (EDSS).|Score (0 to 10), lower score less disability and better progression. For EDSS, mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|24 months||||score on a scale||Standard Deviation|Mean
2782841|NCT00647348|Primary|Percentage Change in Whole Brain Volume||24 months|1 participant had a missing data|||percentage of brain volumen change||Standard Deviation|Mean
2782842|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.|||units on a score||Standard Error|Least Squares Mean
2782843|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.|||units on a score||Standard Error|Least Squares Mean
2782844|NCT00647270|Secondary|Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (LOCF).|||units on a score||Standard Deviation|Mean
2782845|NCT00647270|Secondary|Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (observed).|||units on a score||Standard Deviation|Mean
2782846|NCT00647270|Primary|The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)|Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit|Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.|||participants|||Number
2782847|NCT00646958|Secondary|Number of Patients With Per-Patient Microbiologic Response of Eradicated|The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.|Test of Cure (TOC), day 10-20|Microbiologically Evaluable patients were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before TOC, presented for a TOC evaluation in the appropriate window, and who had a baseline pathogen that was susceptible to study drug.|||Participants|||Number
2782848|NCT00646958|Primary|Number of Participants With a Clinical Response of Cure|To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.|Test of Cure (TOC), day 10-20|Clinically Evaluable participants were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before Test of Cure (TOC), and who presented for a TOC evaluation in the appropriate window.|||Participants|||Number
2782849|NCT00646906|Secondary|Percent Change in Arachidonic Acid Induced Platelet Aggregation|Platelet aggregation was induced by 500 micro molar arachidonic acid using a Chronolog aggregometer. The quantity of interest was percent change from start (8:00 am on day 1) to finish (8:00 am on last day) of each crossover period in platelet aggregation. This was calculated as: 100%*(value at start of period minus value at end of period)/value at start of period.|7 days (only Phase 1a)||||Percent inhibition of baseline||Standard Deviation|Mean
2782850|NCT00646906|Primary|Percent Change in Serum Thromboxane B2|Thromboxan B2 is a stable metabolite of thromboxane A2. Thromboxane B2 formation during clotting of whole blood (37 degrees Celsius, 1 hour) is reflective of the capacity of platelets to form thromboxane A2. Serum Thromboxane B2 was measured by radio-immuno assay. The quantity of interest was percent change from start (8:00 am on day 1) to finish (8:00 am on last day) of each crossover period in serum thromboxane B2. This was calculated as: 100%*(value at start of period minus value at end of period)/value at start of period.|7 days (Phase 1a and 1b), 4 days (Phase 2)||||Percent inhibition of baseline||Standard Deviation|Mean
2783071|NCT00644059|Secondary|Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months||3 weeks after 2nd vaccination|Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.||||||
2782851|NCT00646776|Secondary|Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge|All treated participants.|||Participants|||Number
2782852|NCT00646776|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|Pre-dose on Day -1 and study discharge.|All participants who received the study drug on Day 1 were included in the analysis.|||Participants|||Number
2782853|NCT00646776|Secondary|Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: >=2+ (or, if pre-treatment value >=1+, then >= 2 x pre-treatment value).|Pre-dose on Day -1, Day 7 and discharge.|"All participants who received the study drug on Day 1 were included in the analysis. If a value had not evaluable in the dataset, then these participants were not counted (for all parameters: protein, glucose and blood)."|||Participants|||Number
2782854|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 x LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8 x pre-Rx or >ULN. If pre-Rx >ULN, then >2.0 x pre-Rx or <LLN. Albumin: <0.9 x LLN (if pre-Rx <LLN, then <0.9 x pre-Rx). Creatine kinase: >1.5 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx). Uric acid: >1.2 x ULN (if pre-Rx >ULN, then >1.25 x pre-Rx). LDH: >1.25 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(albumin, creatine kinase, uric acid and LDH)."|||Participants|||Number
2782855|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN). Bicarbonate:<0.8xLLN or >1.2xULN (if pre-Rx value <LLN, then <0.8xpre-Rx value or >ULN. If pre-Rx >ULN, then >1.2xpre-Rx value or <ULN). Phosphorous (inorganic):<0.85xLLN or >1.25xULN (if pre-Rx <ULN, then <0.85xpre-Rx or <ULN. If pre-Rx >ULN, then >1.25x re-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|All treated participants.|||Participants|||Number
2782856|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:>1.25xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:>1.1xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Creatinine:>1.33xpre-Rx. Sodium (serum):<0.95xLLN or >1.05xULN (if pre-Rx <LLN, then <0.95xpre-Rx or >ULN. If pre-Rx >ULN, then >1.05xpre-Rx or <LLN). Potassium (serum):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (ALP, AST, ALT, bilirubin [total], bilirubin [direct], BUN and creatinine)."|||Participants|||Number
2782857|NCT00646776|Primary|Total Area Under the Plasma Concentration-time Curve (AUCtot)|AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar[µM]*h) = AUC24avg(RIB)(ng*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|"All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis. The RIB 300 mg arm represents an extrapolation of the RIB 150 mg arm and as such, does not have a value for Number of Participants Analyzed. AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD."|||µM*h||Full Range|Geometric Mean
2782858|NCT00646776|Primary|Cmin of 25-O-Desacetyl-RIB|Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782859|NCT00646776|Primary|Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)|Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782860|NCT00646776|Primary|AUC24avg for 25-O-Desacetyl-RIB|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng*h/mL||Full Range|Geometric Mean
2782861|NCT00646776|Secondary|Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): <=1.50 x 10^3 cells/microliter (uL). Lymphocytes (absolute): <0.75 x 10^3 cells/uL or >7.50 x 10^3 cells/uL. Monocytes (absolute): >2.00 x 10^3 cells/uL. Basophils (absolute): >0.40 x 10^3 cells/uL. Eosinophils (absolute): >0.75 x 10^3 cells/uL.|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(neutrophils + bands [absolute], monocytes [absolute], basophils [absolute] and eosinophils [absolute])."|||Participants|||Number
2782862|NCT00646776|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: <0.85 x pre-treatment (pre-Rx) value. Platelet count: <0.85 x lower limit of normal (LLN) (or, if pre-Rx value <LLN, then <0.85 x pre-Rx value) or >1.5 x upper limit of normal (ULN). Leukocytes: <0.9 x LLN or >1.2 x ULN (or, if pre-Rx value <LLN, then <0.85 x pre-Rx or >ULN. If pre-Rx value >ULN, then >1.15 x pre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (hemoglobin and hematocrit)."|||Participants|||Number
2782863|NCT00646776|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.|AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as any AE that: resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.|||Participants|||Number
2782864|NCT00646776|Secondary|T-half of RTV|T-half was obtained directly from the concentration-time data.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||Hour||Standard Deviation|Mean
2782865|NCT00646776|Secondary|Tmax of RTV|Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||Hour||Full Range|Median
2782866|NCT00646776|Secondary|AUC(TAU) for RTV|AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||ng*h/mL||Full Range|Geometric Mean
2782867|NCT00646776|Secondary|Cmin of RTV|Cmin was derived from the plasma concentration versus time for RTV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782868|NCT00646776|Secondary|Cmax of RTV|Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782869|NCT00646776|Secondary|Terminal Elimination Half-life (T-half) of ATV|T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||Hour||Standard Deviation|Mean
2782870|NCT00646776|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV|Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||Hour||Full Range|Median
2782871|NCT00646776|Secondary|AUC(TAU) for ATV|AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.|||ng*h/mL||Full Range|Geometric Mean
2783614|NCT00640224|Primary|Peripheral Insulin Sensitivity at Baseline and 6 Months.|Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.|Baseline and 6 months||||mg/kg/min per uU/mL||Standard Error|Mean
2782874|NCT00646776|Primary|Minimum Plasma Concentration (Cmin) of RIB|Cmin was derived from plasma concentration versus time for RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782875|NCT00646776|Primary|Maximum Plasma Concentration (Cmax) of RIB|Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||ng/mL||Full Range|Geometric Mean
2782876|NCT00646776|Primary|Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.|Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.|||nanograms*hour /milliliters (ng*h/mL)||Full Range|Geometric Mean
2782877|NCT00646763|Primary|Number of Participants for Whom Target Number of CD34+ Cells Were Collected.|Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment|7 days||||participants|||Number
2782878|NCT00646763|Secondary|Total Number of Days of Apheresis|the number of days of apheresis required to collect target numbers of CD34+ cells.|7 days||||days||Standard Deviation|Mean
2782879|NCT00646763|Primary|The Total Number of CD34+ Cells Collected.||4 days|Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin’s disease, non-Hodgkin’s lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.|||cells per Kg||Standard Deviation|Mean
2782880|NCT00646646|Primary|Dynamic Eye Movement Measures|Change in Eye Movements Parameters|baseline to Sedation State (approx. 1 hr)||||(degrees/second)||95% Confidence Interval|Mean
2782881|NCT00646581|Primary|Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||Proportion of overall attempts||Standard Deviation|Mean
2782882|NCT00646581|Primary|Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||Milliseconds||Standard Deviation|Mean
2782883|NCT00646581|Primary|Improvement in Cognitive Function- CPT Hits Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure (CPT d score). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized either to the experimental or placebo group.|||Proportion of overall attempts||Standard Deviation|Mean
2782884|NCT00646581|Primary|CPT d Score|"Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||units on a scale||Standard Deviation|Mean
2782885|NCT00646581|Primary|Improvement in Cognitive Function- HVLT-Delayed Recall (Number)|Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed in this study. Subjects were randomized to either the experimental or placebo group.|||Words successfully recalled||Standard Deviation|Mean
2785760|NCT00623623|Secondary|Number of Patients With Ischaemic Stroke|This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2782886|NCT00646581|Primary|Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)|Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.|||Words successfully recalled||Standard Deviation|Mean
2782887|NCT00646399|Primary|The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.|Safety and efficacy|35 days|1579 very low birth weight subjects were included in the ITT.|||Participants|||Number
2782888|NCT00646282|Primary|Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels|Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months|18 months|Data not analyzed due to study termination||||||
2782889|NCT00646113|Primary|Implant Survival Rate|Overall implant survival rate evaluated clinically and radiographically|Evaluated at implant placement and at the 5 years follow-up after implant placement|A total of 69 subjects were enrolled in the study and received a total of 97 implants.|||Implants|Implants||Count of Units
2782890|NCT00646048|Secondary|Number of Participants Who Achieve Technical Success of the Stent Graft System.|Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.|Post procedure||||Participants|||Number
2782891|NCT00646048|Primary|Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).|A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.|1 month||||Participants|||Number
2782892|NCT00646048|Primary|Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.|Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.|1 month||||Participants|||Number
2782893|NCT00645970|Primary|Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale)|"Numeric Pain Rating Scale is a self-report measure of usual (average) pain intensity over the last week; response options range from no pain (0) to worst pain imaginable (10). A score >3 indicates moderate-to-severe pain."|Baseline, 6 months, 1 year|Numeric Pain Rating Scale data are missing for 21 participants (PSC n=1; Registry n=20)|||units on a scale||Standard Deviation|Mean
2782894|NCT00645944|Primary|Change in Insomnia Severity Index From Baseline.|The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach's alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.|8 Weeks|Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis|||units on a scale||95% Confidence Interval|Least Squares Mean
2782895|NCT00645853|Secondary|AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment||154-711 days on treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis|||nmol/L||Full Range|Median
2782896|NCT00645853|Secondary|AZD0837: Plasma Concentration of AZD0837 at End of Treatment||End of treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis|||nmol/L||Full Range|Median
2782897|NCT00645853|Secondary|Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment||Baseline and End of Treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis|||sec||Full Range|Median
2782898|NCT00645853|Secondary|Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment|Median Full range, Seconds|Baseline and End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis|||sec||Full Range|Median
2782899|NCT00645853|Secondary|D-dimer:Median and Quartile Range at End of Treatment|Median (Lower Quartile-Upper Quartile ), ng/mL|End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis|||ng/mL||Inter-Quartile Range|Median
2782900|NCT00645853|Secondary|Creatinine: Absolute Change From Baseline, at End of Treatment||Baseline and End of treatment||||µmol/L||Full Range|Mean
2782901|NCT00645853|Secondary|Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline||From baseline to Follow up||||Participants|||Number
2782902|NCT00645853|Secondary|Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline|ULN=Upper limit of Normal|From baseline to Follow up||||Participants|||Number
2782903|NCT00645853|Primary|Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period|Participants|154-711 days on treatment||||Participants|||Number
2782942|NCT00645450|Primary|PTSD Symptom Severity as Measured by Clinician-Administered PTSD Scale (CAPS)|CAPS scale measures intensity and frequency of each symptom separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity|3 years|Data does not include subjects who consented but withdrew prior to receiving study intervention.|||score on a scale||Standard Deviation|Mean
2782904|NCT00645840|Secondary|C-peptide Secretory Capacity|Mixed-meal tolerance tests. MMTTs were conducted at the UT Southwestern Clinical Translational Research Center (CTRC). Subjects underwent MMTTs at 3-4 wk after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed by Dr Philip Raskin (UTSouthwestern MedicalCenter, Dallas, TX,USA). C-peptide AUC was calculated for each MMTT using the trapezoidal method. C-peptide AUC data between groups were rank transformed and then analyzed using a two-way repeated measures analysis of variance (ANOVA).|7 months|Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed.|||ng/mL/2h||Inter-Quartile Range|Median
2782905|NCT00645840|Primary|Effect of Anakinra Treatment on PBMC Gene Expression for Patients|Expression data at baseline and after treatment were available on 10 patients who had received anakinra. These were compared to similarly-timed samples from 10 patients from control group B. Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed.|1 month|We enrolled 15 subjects to receive anakinra. Of these subjects, three were later found to have negative autoantibodies and were excluded from further analyses. One subject withdrew from participation and stopped anakinra after two doses. We stopped study drug for another subject after 19 days of therapy due to an adverse event.|||probe sets|probe sets||Number
2782906|NCT00645827|Secondary|Hypoglycemia (Serum Blood Glucose < 70 mg/dL)||Within 24 hours after cessation of IV insulin|||||||
2782907|NCT00645827|Primary|Percentage of Blood Glucose Values Within 80-140 mg/dL|Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL|Within 24 hours after cessation of IV insulin||||percentage of blood glucose values|||Number
2782908|NCT00645788|Secondary|Number of Participants With the Occurrence of Drug Induced Bronchospasms|"Bronchospasm reported as adverse event: Bronchospasm defined as >=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as >=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under other adverse events. A sum of bronchospasm events was 1+6=7."|Up to visit 9 (Day 56-60)|Intent to treat|||participants|||Number
2782909|NCT00645788|Secondary|Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment|Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.||||||
2782910|NCT00645788|Secondary|Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment|Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), <15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.||||||
2782911|NCT00645788|Secondary|Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale|The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values.|Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60)|Intent to treat|||scores on a scale||Standard Deviation|Mean
2782912|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates|"Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The susceptible bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy."|Baseline and up to visit 9 (day 56-60)|Intent to treat|||Participants|||Number
2782913|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates|"Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The susceptible bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy."|Baseline and up to visit 9 (day 56-60)|Intent to treat|||Participants|||Number
2782914|NCT00645788|Secondary|Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9|FEF 25-75% (also known as the maximum midexpiratory flow [MMEF]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||Percent of predicted FEF 25-75%||Standard Deviation|Mean
2782915|NCT00645788|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9|FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||Percent of predicted FVC||Standard Deviation|Mean
2782916|NCT00645788|Secondary|Time to First Pulmonary Exacerbation Requiring Intervention|Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite.|Up to visit 9 (Day 56-60)|Intent to treat|||Days||Inter-Quartile Range|Median
2782917|NCT00645788|Secondary|Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9|Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||log10(cfu/g)||Standard Deviation|Mean
2782918|NCT00645788|Secondary|Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat|||Percent of predicted FEV1||Standard Deviation|Mean
2782919|NCT00645788|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28‑30|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and End of treatment (Day 28-30)|Intent to treat|||Percent of predicted FEV1||Standard Deviation|Mean
2782920|NCT00645762|Primary|Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement|"Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful."|Post-treatment through 12 months|Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure.|||Scores on a scale|||Number
2782921|NCT00645762|Primary|Patency of the Treated Area as Verified by CT Scan|Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.|Post-treatment at 3 months|Analysis of ostia patency done per protocol|||Ostia|Participants||Number
2782922|NCT00645762|Primary|Incidences of Device-related or Procedure-related Complications||Through 12 months post-procedure|Patients completing 12 month follow-up|||participants|||Number
2782923|NCT00645710|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined as a 25% increase in the sum of products of measurable lesions over the smallest sum observed, or appearance of any lesions that had disappeared, or appearance of any new lesion/site.|Up to 5 years||||Months||95% Confidence Interval|Median
2782924|NCT00645710|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.|Up to 5 years||||Months||95% Confidence Interval|Median
2782925|NCT00645710|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD) of HAI FUdR in combination with intravenous gemcitabine and 90Y-DTPA-cT84.66 is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.|4 weeks from start of treatment, up to 2 years.|All patients observed for 56 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg/kg/day|||Number
2782926|NCT00645710|Primary|Number of Participants With at Least One Dose Limiting Toxicity|Dose Limiting Toxicity (DLT) defined as any treatment-related grade grade 3 nonhematologic toxicity not reversible to grade 2 or less within 24 hours, or any grade 4 toxicity.Up to three cycles of therapy were allowed with DLTs determined based on first cycle tolerance. Toxicity was graded using the National Cancer Institute Common Toxicity Criteria version 2.0.|4 weeks from start of treatment, up to 2 years.|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
2782927|NCT00645671|Primary|Grade 0 for Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative Day 8 (Visit 5)|Intent to treat population|||participants|||Number
2782928|NCT00645671|Secondary|Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Baseline and each follow-up visit through day18 (Visit 7)|Intent to treat population|||Composit scores||Standard Deviation|Mean
2782929|NCT00645671|Secondary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each follow-up visit through day18 (Visit 7)|Intent to treat population|||participants|||Number
2782930|NCT00645671|Primary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 8 (Visit 5)|Intent to treat population|||participants|||Number
2782931|NCT00645593|Secondary|Median Overall Survival in Months|Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.|||Months||95% Confidence Interval|Median
2782932|NCT00645593|Secondary|Median Progression-free Survival Time in Months|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.|||months||95% Confidence Interval|Median
2782933|NCT00645593|Secondary|The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2|"One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting."|3 years|Although 60 participants were enrolled and randomized to arm 2, 1 participant withdrew consent prior to treatment and was therefore excluded from toxicity analysis.|||adverse events|||Number
2782934|NCT00645593|Primary|Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2|"The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab.~Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest diameter of target lesions)."|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
2782935|NCT00645567|Primary|Shoulder Force|measurement of applied shoulder force during wheelchair transfers|None reported - verifiable data is not available for any of the participants|As of the November 2012 update to the IRB, there were no findings at that point. At this time, verifiable data is not available for any of the participants.||||||
2782936|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here."|Visit 2 (week 2)||||units on a scale||Standard Deviation|Mean
2782937|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here."|Visit 1 (week 0)||||units on a scale||Standard Deviation|Mean
2782938|NCT00645528|Secondary|Number of Patients Experiencing a Severe Hypoglycemic Event|Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia|2 weeks||||participants|||Number
2782939|NCT00645528|Secondary|Number of Subjects Experiencing Hypoglycemic Symptoms|Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits|2 weeks|As below, 15 subjects reported subjective symptoms of hypoglycemia in the two weeks between study visits; 10 of these subjects had at least one recorded blood glucose value less than 70 mg/dl; Eight of these 10 subjects had started insulin.|||participants|||Number
2782940|NCT00645528|Secondary|Percent of Patients Who Begin Insulin||2 weeks||||percentage of participants|||Number
2782941|NCT00645528|Primary|"Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes"|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test."|2 weeks|32 subjects completed the study|||units on a scale||Standard Deviation|Mean
2782992|NCT00644995|Primary|Days Walk Per Week|Mean change in days walk per week from baseline|6 months||||mean change in days walked per week||Full Range|Mean
2782993|NCT00644995|Primary|Abstinent From Smoking|self-reported 7 day point prevalent abstinence with non-responders coded as smokers|6 months||||percentage of participants|||Number
2782943|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.|To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.|up to 7 days after each vaccination|The analysis was performed on the safety dataset set.|||Subjects|||Number
2782944|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .|up to 7 days after vaccination|The analysis was performed on the safety dataset|||Subjects|||Number
2782945|NCT00645411|Secondary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.~According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
2782946|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.~The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
2782947|NCT00645411|Secondary|Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.~The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5"|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2782948|NCT00645411|Secondary|Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children|To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
2782949|NCT00645411|Secondary|Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.~According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
2782950|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.~This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
2782951|NCT00645411|Secondary|Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|"Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2782952|NCT00645411|Secondary|Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.~GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
2782953|NCT00645411|Primary|Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.~Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset|||Percentages of subjects||95% Confidence Interval|Number
2782954|NCT00645411|Primary|Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.~GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset|||Titers||95% Confidence Interval|Geometric Mean
2782955|NCT00645359|Primary|The Odds Ratio (OR) Between Tumor Response (Based on Changes in MR Imaging) and Duration of Response|To correlate the changes on MR images with the tumor response after completion of chemotherapy and duration of response. Tumor response will be determined by the clinical evaluation, tumor dimensions, and metabolic response as assessed by 18-Fluoro-deoxy.|2 years|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.||||||
2782956|NCT00645359|Primary|Mean Difference in Apparent Diffusion Coefficient|To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma, the ADC value will be calculated at the voxel level, on baseline and Day 8, and the mean difference will be calculated.|Baseline and Day 8|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.||||||
2782957|NCT00645333|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) for MK-0752 will be determined. Dose levels were: Level 1: 300 mg MK-0752 by mouth days 1-3; Level 2: 450 mg MK-0752 by mouth days 1-3; Level 3: 600 mg MK-0752 by mouth days 1-3; Level 4: 800 mg MK-0752 by mouth days 1-3.|Up to 3 years||||mg|||Number
2782958|NCT00645333|Primary|Dose Limiting Toxicity (DLT)|"The number of DLTs experienced by participants within the first 21 days.~DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:~Non-hematologic toxicity Grade ≥3 by the NCI CTCAE version 3.0.~ANC<1000 for more than 7 days despite use of pegfilgrastim.~Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time."|first 21 days||||Dose Limiting Toxicities|||Number
2782959|NCT00645164|Primary|Frequency Distribution of Skin Irritation Scores|Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.|48-hours post irradiation|Analysis was based on number of subjects who completed the study.|||Scores on a scale|||Number
2782960|NCT00645099|Secondary|Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)|PANSS is an investigator-rated 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provided a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline to End Point (up to 6 months)|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||points on a scale||Standard Deviation|Mean
2782961|NCT00645099|Secondary|Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up|"Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on~Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met:~waist circumference men > 102 cm; waist circumference women > 88 cm~TG ≥ 150 mg/dL~HDL cholesterol men <40 mg/dL; HDL cholesterol women <50 mg/dL~Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg~Fasting glucose ≥ 110 mg /dL"|6 months|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. In this case, the total number of patients in the analysis set depends on the number of patients without metabolic syndrome at baseline.|||Participants|||Number
2782962|NCT00645099|Secondary|Change From Baseline at End Point in Waist Circumference|Patients had to be instructed to stand erect with abdomen relaxed, arms at sides, feet together, and weight divided equally over both legs. The tape measure was placed around the bare abdomen midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. A nonstretchable tape was evenly placed around the natural waist covering the left and right natural-waist marks. The measurement scale had to face outward, and there could not be any twists in the tape. The tape had to be just touching the skin but not compressing the soft tissue.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||cm||Standard Deviation|Mean
2782963|NCT00645099|Secondary|Change From Baseline at End Point in Body Mass Index (BMI)|BMI is calculated by dividing the body weight (in kg) by the square of height (in meters).|Baseline to End Point (up to 6 months)||||kg/m²||Standard Deviation|Mean
2782964|NCT00645099|Secondary|Change From Baseline at End Point in Body Weight|Patients were weighed lightly clothed. The same amount of clothing had to be worn each time.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||kg||Standard Deviation|Mean
2782965|NCT00645099|Secondary|Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin|As another measure of beta-cell function, the relationship between plasma insulin and glucose concentrations during the OGTT was calculated using a simplified version of the method described by Mari et al. (Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab. 2005; 90:4888-4894.).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||pM/mM||Standard Deviation|Mean
2782966|NCT00645099|Secondary|Change From Baseline at End Point of the Insulinogenic Index|The insulinogenic index, defined as (insulin at 30 min - insulin at 0)/(glucose at 30 min [G(30)] - glucose at 0 [G(0)]) was used as a measure of early insulin secretion in response to the OGTT. Because the index is undefined when G(30)-G(0)=0, and poorly defined when G(30)-G(0)<0, the index was only calculated when G(30)>G(0).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||pM/mM||Standard Deviation|Mean
2782967|NCT00645099|Secondary|Number of Patients With Impaired Fasting Glucose|Post-baseline glucose level under fasted conditions ≥100 mg/dL but <126 mg/dL.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||Participants|||Number
2782968|NCT00645099|Secondary|Number of Patients With Onset of Impaired Glucose Tolerance|Glucose ≥140 mg/dL, <200 mg/dL after a 75g OGTT.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||Participants|||Number
2782969|NCT00645099|Secondary|Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up|Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study.|6 months|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||Participants|||Number
2782970|NCT00645099|Secondary|Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||dimensionless||Standard Deviation|Mean
2782971|NCT00645099|Secondary|Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)|"HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level).~HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%."|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post baseline data for the particular secondary efficacy parameter under discussion.|||dimensionless||Standard Deviation|Mean
2782972|NCT00645099|Secondary|Change From Baseline to End Point in Fasting Glucose||Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||mmol/L||Standard Deviation|Mean
2782973|NCT00645099|Secondary|Change From Baseline to End Point in Converted Insulin|The insulin level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||pmol/L||Standard Deviation|Mean
2782974|NCT00645099|Secondary|Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)|The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||mmol/L||Standard Deviation|Mean
2782975|NCT00645099|Secondary|Change From Baseline to End Point in Total Cholesterol|The total cholesterol level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the Intent-to-Treat (ITT) analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.|||mmol/L||Standard Deviation|Mean
2782976|NCT00645099|Secondary|Change From Baseline to End Point in High Density Lipoprotein|The HDL level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||mmol/L||Standard Deviation|Mean
2782977|NCT00645099|Secondary|Change From Baseline to End Point in Triglycerides|The TG level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.|||mmol/L||Standard Deviation|Mean
2782994|NCT00644995|Primary|Depression Score|% with significant change (50% reduction in SCL [Symptom Checklist] depression score)|6 months||||percentage of participants|||Number
2782978|NCT00645099|Primary|Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)|Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio.|Baseline to End Point (up to 6 months)|The primary end point analysis set consisted of 413 patients, i.e., all patients who received study medication at least once and had baseline and post-baseline TG and HDL data. Data of patients with missing TG or HDL values or who started or changed lipid-lowering medication during the trial were excluded from analysis.|||Ratio||Standard Deviation|Mean
2782979|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.~A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|6 Month Visit||||units on a scale||Standard Deviation|Mean
2782980|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.~A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|Post Visit||||units on a scale||Standard Deviation|Mean
2782981|NCT00645047|Secondary|PTSD Checklist (PCL)|"PTSD Checklist-Military Version (PCL). The PCL is a 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. The PCL has a variety of purposes, including screening individuals for PTSD, diagnosing PTSD, and monitoring symptom change during and after treatment.~A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely."|Baseline||||units on a scale||Standard Deviation|Mean
2782982|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.~Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|6 Month Visit||||units on a scale||Standard Deviation|Mean
2782983|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.~Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|Post Visit||||units on a scale||Standard Deviation|Mean
2782984|NCT00645047|Secondary|Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.~Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression."|Baseline||||units on a scale||Standard Deviation|Mean
2782985|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.~Severity Rating~0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.~Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|6 Month Visit||||units on a scale||Standard Deviation|Mean
2782986|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.~Severity Rating~0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.~Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|Post Visit||||units on a scale||Standard Deviation|Mean
2782987|NCT00645047|Primary|CAPS - PTSD Symptom Severity Score|"The CAPS-5 is a 30-item clinician administered interview designed to diagnose current and lifetime PTSD and to assess PTSD symptom-severity over the past week. The interview assesses 20 DSM-5 PTSD symptoms as well as onset, duration, distress, and functional impact, overall validity, PTSD severity, and presence of dissociation. Prior to assessing symptoms, the clinical interviewer works with the patient to establish an index-trauma and each follow-up question focuses on symptoms as they relate to the index trauma.~Severity Rating~0. Absent; 1. Mild / subthreshold; 2. Moderate / threshold; 3. Severe / markedly elevated; and 4. Extreme / incapacitating.~Higher scores means more severe symptoms. Total symptom severity score may range from 0-80, higher scores meaning more severe symptoms."|Baseline||||units on a scale||Standard Deviation|Mean
2782988|NCT00644995|Secondary|Quit Attempt|% who made a quit attempt, defined as intentionally not smoking for at least 24 hours|6 months||||percent of participants|||Number
2782989|NCT00644995|Secondary|Number of Cigarettes Smoked Per Day|Mean change in cigarettes smoked per day from baseline|4 months||||mean change in number of cigs/day smoked||Full Range|Mean
2782990|NCT00644995|Primary|Minutes Per Week of Vigorous Physical Activity|Mean change from baseline assessed using IPAQ physical activity scale|6 months||||minutes per week||Full Range|Mean
2782991|NCT00644995|Primary|Minutes Per Week of Moderate Physical Activity|Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)|6 months||||mean change in minutes per week of PA||Full Range|Mean
2782997|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 24|FAS|||participants|||Number
2782998|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 12|Full analysis set (FAS): all participants randomized into the study who received at least 1 dose of study treatment (formerly referred to as the All subjects analysis set).|||participants|||Number
2782999|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||participants|||Number
2783000|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 12|Safety analysis set; N=number of participants with analyzable data at observation.|||participants|||Number
2783001|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 1|Safety analysis set; N=number of participants with analyzable data at observation.|||participants|||Number
2783002|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline to Week 24|Safety analysis set; N=number of participants with evaluable data at observation.|||participants|||Number
2783003|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline (Bsl) to Week 12|Safety analysis set; N=number of participants with evaluable data at observation.|||participants|||Number
2783004|NCT00644969|Primary|"Number of Participants With Suicidal Behavior or Suicical Ideation (Yes Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 13 to Week 24 (Post treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with new suicidal behavior and / or ideation."|||participants|||Number
2783005|NCT00644969|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 1 to Week 12 (Treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with continued or new suicidal behavior and / or ideation. Treatment phase includes a 7 day lag after last dose of study treatment."|||participants|||Number
2783006|NCT00644969|Primary|Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
2783007|NCT00644969|Primary|Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
2783008|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
2783009|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
2783010|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
2783011|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
2783012|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
2783013|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.|||scores on a scale||Standard Deviation|Mean
2783014|NCT00644969|Primary|Number of Participants With Psychiatric Adverse Events|Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.|Baseline up to Week 24|Safety analysis set; Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment). Neuropsychiatric events assessed through Week 24.|||participants|||Number
2783015|NCT00644969|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.|Baseline up to 30 days after last dose of study treatment or up to Week 16|Safety analysis set: all participants who took at least 1 dose of randomized study medication, including partial doses and had a safety measurement. Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment).|||participants|||Number
2783016|NCT00644917|Primary|Skin Reaction Score|Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.|48 hours|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2783017|NCT00644787|Secondary|Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
2785761|NCT00623623|Secondary|Number of Patients With Intracranial Haemorrhage|This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2783018|NCT00644787|Secondary|Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 14|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2783019|NCT00644787|Secondary|Mean Number of Rescue Doses in Double Blind Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Rescue doses||Standard Deviation|Mean
2783020|NCT00644787|Secondary|Mean Number of Rescue Doses in Titration Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Rescue doses||Standard Deviation|Mean
2783021|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Double Blind Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783022|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Titration Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783023|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783024|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783025|NCT00644787|Secondary|Percentage of Participants Achieving Pain Control in Double Blind Phase|Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.|Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.|||Percentage of participants||95% Confidence Interval|Number
2783026|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase|"Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as no pain and the right edge (100 mm) defined as severest pain conceivable."|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2783027|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase|"Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as no pain and the right edge (100 mm) defined as severest pain conceivable."|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2783028|NCT00644787|Secondary|Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783029|NCT00644787|Secondary|Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783030|NCT00644787|Primary|Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase|The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).|Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)|Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.|||mm||Standard Deviation|Mean
2783031|NCT00644787|Primary|Percentage of Participants Achieving Dose Titration Success|Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.|Day 14 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2783032|NCT00644657|Secondary|The Percentage of Coated Platelets After Coronary Angiography and/or PCI|The percentage of coated platelets 24 hours after coronary angiography and/or PCI|6 hrs after procedure||||Percentage of platelets that are coated||Standard Deviation|Mean
2783033|NCT00644657|Primary|The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty|The percentage of platelets that are collagen coated after the administration of clopidogrel.|24 hours after the administration of clopidotrel||||Percent of platelets that are coated.||Standard Deviation|Mean
2783034|NCT00644592|Primary|Log(ENA-Period 2 End/ENA Period 1 End)|"Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.~Natural logs used"|week 12 to week 4|Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods|||Log of Ratio||Standard Deviation|Mean
2783035|NCT00644423|Secondary|Trail Making B|Mean change scores in attention and cognition (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part B is a timed test that consists of 25 circles on a piece of paper with both numbers (1 - 13) and letters (A - L); the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The respondent is asked to draw a line from number one, and so on,in correct numerical/alphabetical order, until they reach number 13. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)||||seconds||Standard Error|Mean
2783036|NCT00644423|Secondary|Trail Making A|Mean change scores in cognition and attention (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a line from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)||||seconds||Standard Error|Mean
2783037|NCT00644423|Secondary|Continuous Performance Test (CPT)|Mean change scores in inpulsivity (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)|Missing CPT scores from 2 participants in the Omega-3 Fatty Acid arm.|||Q-score||Standard Error|Mean
2783072|NCT00644059|Secondary|Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child||3 weeks after 2nd vaccination|As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.||||||
2783038|NCT00644423|Secondary|Connor Davidson Resilience Scale (CD-RISC)|Mean change scores in resiliency (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)||||units on a scale||Standard Error|Mean
2783039|NCT00644423|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Mean change scores in depressive symptomatology (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability, sleep,weight/appetite change, and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity). Higher values reflect more severe symptoms.|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)||||units on a scale||Standard Error|Mean
2783040|NCT00644423|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|Mean change scores to assess cognitive changes (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)||||Z-score||Standard Error|Mean
2783041|NCT00644423|Primary|Clinician-Administered PTSD Scale (CAPS)|Mean change scores in posttraumatic stress disorder symptoms (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.|Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)||||units on a scale||Standard Error|Mean
2783042|NCT00644358|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a clinician-rated scale for assessing improvement of a patient's condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.|Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.|||score on a scale||Standard Deviation|Mean
2783043|NCT00644358|Secondary|Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score|The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.|||score on a scale||Standard Deviation|Mean
2783044|NCT00644358|Secondary|Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination|Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.|||score on a scale||Standard Deviation|Mean
2783045|NCT00644358|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).|From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)|Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.|||Participants|||Number
2783046|NCT00644332|Secondary|Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI|The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis.|Baseline to Week 4|Data was collected for this outcome, however, the analysis was not done.|||coefficient of determination|||Number
2785762|NCT00623623|Secondary|Number of Patients With Total Non-disabling Stroke|This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2783047|NCT00644332|Primary|Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis|Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set|||coefficient of determination|||Number
2783048|NCT00644332|Primary|Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value|Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set|||ratio of variances|||Number
2783049|NCT00644332|Secondary|Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment|The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline to Week 4|Modified Intent-to-Treat Analysis Set|||DASI scale units||Standard Error|Mean
2783050|NCT00644332|Secondary|Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries|Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set~Missing values were excluded"|||uses per week||Standard Error|Mean
2783051|NCT00644332|Secondary|Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries|Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set~Missing values were excluded"|||attacks per week||Standard Error|Mean
2783052|NCT00644332|Primary|Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)|Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set, defined as all patients who took at least 1 dose of ranolazine and completed both baseline and postbaseline questionnaires. Partially missing questionnaire responses were imputed by the methods specified in the scoring instructions; completely missing responses were not imputed.|||coefficient of determination|||Number
2783053|NCT00644332|Secondary|Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set|||SAQ scale units||95% Confidence Interval|Number
2783054|NCT00644332|Secondary|Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set|||SAQ scale units||95% Confidence Interval|Number
2783055|NCT00644332|Secondary|Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ - ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set|||ratio of variance||95% Confidence Interval|Number
2783056|NCT00644280|Secondary|Significant Ocular Adverse Events|Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment|6 months||||participants|||Number
2783057|NCT00644280|Primary|Tube Success at 6 Months|Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.|6 months||||percentage of participants|||Number
2783073|NCT00644059|Secondary|Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons||7 days post-vaccination|Adequate data was not available to conduct this analysis.||||||
2783058|NCT00644228|Secondary|Response Rates ()|The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.|Up to 6 years|All eligible, analyzable patients are included.|||Participants|||Count of Participants
2783059|NCT00644228|Secondary|Overall Survival|Unstratified median overall survival in months.|Up to 6 years|All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.|||Months||95% Confidence Interval|Median
2783060|NCT00644228|Primary|Progression-free Survival|Unstratified median progression-free survival in months.|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years|All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.|||Months||95% Confidence Interval|Median
2783061|NCT00644189|Secondary|Phase I Participants: Safety|Grade 2-4 toxicities and grade 3-4 infections among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|during 6 28-day cycles and 90 days out|Phase I participants only|||Participants|||Count of Participants
2783062|NCT00644189|Secondary|All Phase I Participants: Overall Survival (OS)|Determine the overall survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|at 17 months|Phase I participants only|||percentage of participants||90% Confidence Interval|Mean
2783063|NCT00644189|Secondary|Phase I Participants: Progression-free Survival (PFS)|"Determine the progression-free survival rate among all phase I trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg).~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|at 17 months|Phase I participants only|||percentage of participants||90% Confidence Interval|Mean
2783064|NCT00644189|Secondary|Phase I Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)|"To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|Phase I participants only who were treated at the RP2D (3mg)|||Participants|||Count of Participants
2783065|NCT00644189|Secondary|All Phase I-II Participants: Safety|Grade 3-4 toxicities among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|during 6 28-day cycles and 90 days out|all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine|||Participants|||Count of Participants
2783066|NCT00644189|Secondary|All Phase I-II Participants: Overall Survival (OS)|Determine the overall survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg)|3 years|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine|||percentage of participants||95% Confidence Interval|Number
2783067|NCT00644189|Secondary|All Phase I-II Participants: Progression-free Survival (PFS)|"Determine the progression-free survival rate among all phase I-II trial participants who are treated with any of the 4 dose levels of oral clofarabine (1mg, 2mg, 4mg, or 3mg).~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|at 1 and 2 years|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine|||percentage of patients||95% Confidence Interval|Number
2783068|NCT00644189|Secondary|Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)|"To determine the efficacy of oral clofarabine (3mg) in patients with relapsed/refractory non-Hodgkin lymphoma. The 3mg dose was declared the recommended phase 2 dose (RP2D) from phase I.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|only participants from phase I-II trial who were treated at the RP2D (3mg)|||percentage of participants||95% Confidence Interval|Number
2783069|NCT00644189|Primary|Phase I Participants Only: Overall Response Rate (ORR)|"Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I trial patients with relapsed/refractory non-Hodgkin lymphomas.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|Phase I participants only|||percentage of participants||90% Confidence Interval|Mean
2783070|NCT00644189|Primary|All Phase I-II Participants: Overall Response Rate (ORR)|"Determine the efficacy of oral clofarabine (any of the 4 dose levels: 1mg, 2mg, 4mg, and 3mg) in all phase I-II trial patients with relapsed/refractory non-Hodgkin lymphomas.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|after at most 6 28-day cycles|all participants from phase I-II trial who are treated with any of the 4 dose levels of oral clofarabine|||percentage of participants||95% Confidence Interval|Number
2809295|NCT00456365|Secondary|Percentage Change in Total Kidney Volume Corrected for Height||3 years|ITT|||Percent change||Standard Deviation|Mean
2783074|NCT00644059|Secondary|Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.~Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
2783075|NCT00644059|Secondary|Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains|"Hemagglutination Inhibition (HI) assay was used for the analysis.~Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
2783076|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.~The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
2783077|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 and GMT-TIV-adj/GMT-Non Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.|On study days 1, 29, 50 , 181|The analysis was done on Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
2783078|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.~Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
2783079|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)|Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set|||Percentage of subjects||95% Confidence Interval|Number
2783080|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points.~Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
2783081|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)|"The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.~The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
2783082|NCT00644059|Secondary|Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.|The number of events of Influenza like Illness reported by subjects aged 6 to <72 months was assessed for combined seasons 2007/08 and 2008/09|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set|||Events||Standard Deviation|Mean
2783083|NCT00644059|Secondary|Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set|||Days||Standard Deviation|Mean
2783084|NCT00644059|Secondary|Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set|||Number of subjects|||Number
2783085|NCT00644059|Secondary|Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to <72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set|||Number of subjects|||Number
2783086|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).|"Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.~For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set|||Percentage of subjects|||Number
2783087|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)|"Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.~For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set|||Percentage of subjects|||Number
2783088|NCT00644059|Secondary|Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination|Number of subjects aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study|Study day 1 to Study day 181|The analysis was done on Safety set|||Number of subjects|||Number
2783089|NCT00644059|Secondary|Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination|Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.|7 days post-vaccination|The analysis was done on Safety set|||Number of subjects|||Number
2783090|NCT00644059|Primary|Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)|Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.|||Percentage of subjects|||Number
2783091|NCT00644059|Primary|Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.|Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.|7 days post-vaccination|The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.|||Number of subjects|||Number
2783092|NCT00643916|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.|Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.|Day 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.|||Percentage of participants|||Number
2783093|NCT00643916|Primary|Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.||Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2|Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Percentage of Participants|||Number
2783094|NCT00643864|Secondary|Arm Motor Ability Test - Timed|The time in seconds to complete 28 tasks is recorded. The tasks are: 1 pick up utensils, 2 cut meat, 3 fork to mouth, 4 pick up sandwich, 5 sandwich to mouth, 6 pick up spoon, 7 bean in spoon, 8 spoon to mouth, 9 grasp mug handle, 10 mug to mouth, 11pick up comb, 12 comb hair, 13 grasp jar top, 14 open jar, 15 tie lace, 16 phone to ear, 17 press phone number, 18 wipe up water, 19 throw away towel, 20 paretic arm in sleeve, 21 button two buttons, 22 arms in T-shirt, 23 shirt over head, 24 straighten shirt, 25 prop on extended arm, 26 turn on light, 27 open door, 28 close door. The total time in seconds to complete all 28 tasks is recorded - as a total summary score. There is no minimum value. There is no maximum value. Lower scores (e.g., less time to complete the 28 tasks) indicate faster performance and better outcome.|pre intervention and post intervention|One group pre post design|||seconds||Standard Deviation|Mean
2783095|NCT00643864|Secondary|Arm Motor Ability Test|The Arm Motor Ability Test evaluates disabilities in upper extremity function in activities of daily living using a quantitative and qualitative measure. The Functional Ability Scale and the Quality of Movement Scale are rated on an ordinal scale from 0-5. The score for the Functional Ability Scale ranges from 0 to 140. The score for the Quality of Movement Scale ranges from 0 to 140. Higher scores on the Functional Ability and Quality Scale of the Arm Motor Ability Test indicate more normal movement and a better outcome.|preintervention and post intervention||||units on a scale||Standard Deviation|Mean
2783096|NCT00643864|Primary|The Fugl-Meyer Assessment of Motor Function After Stroke|The Fugl-Meyer Assessment of Motor Function After Stroke, a widely used scale of motor recovery after stroke. The subscale upper extremity motor function was used. This test requires progressively more complex movements and hand grasps and measure speed and coordination. Each item is graded on a 3-point ordinal scale (0=cannot perform; 1=partially performs; 2=performs fully) with a minimum score of 0 and a maximum score of 66 for the upper extremity. Higher scores indicate better outcome.|preintervention and post intervention||||score on a scale||Standard Deviation|Mean
2783120|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2783097|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with BMI ≥ 27 kg/m2|||kg||Standard Error|Mean
2783098|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
2783099|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) in subjects with baseline HbA1c ≥ 9%|||% of hemoglobin||Standard Error|Mean
2783100|NCT00643851|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||Percentage of participants||Standard Error|Mean
2783101|NCT00643851|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2783102|NCT00643851|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
2783103|NCT00643760|Secondary|Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
2783150|NCT00643565|Secondary|Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response|EFS events was described in Outcome Measure 1 and Outcome Measure 3.|Screening up to approximately 6.75 years|ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||percentage of participants|||Number
2783104|NCT00643760|Secondary|Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
2783105|NCT00643760|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
2783106|NCT00643760|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Any time post-baseline until date of last dose of study medication (up to Week 13)|ITT Population|||days||Full Range|Median
2783107|NCT00643760|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||participants|||Number
2783108|NCT00643760|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants had a CGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||participants|||Number
2783109|NCT00643760|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a PGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||participants|||Number
2783110|NCT00643760|Secondary|Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT|Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a 50-foot walk at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
2783111|NCT00643760|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-MPQ assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
2783165|NCT00643279|Primary|Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.|"A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters.~Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months."|Within 6 months post-implant||||Participants|||Count of Participants
2783112|NCT00643760|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an NPS assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||scores on a scale||Standard Error|Least Squares Mean
2783113|NCT00643760|Secondary|Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||milligrams||Standard Error|Least Squares Mean
2783114|NCT00643760|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
2783115|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
2783116|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2783117|NCT00643760|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2783118|NCT00643760|Secondary|Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a current (morning) pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
2783119|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate an average night-time pain intensity score for the EOMT timepoint.|||scores on a scale||Standard Error|Least Squares Mean
2783149|NCT00643565|Secondary|Duration of Response|Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2783121|NCT00643760|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2783122|NCT00643682|Secondary|Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.|The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.|2 years||||participants who had a colonoscopy|||Number
2783123|NCT00643682|Secondary|Time to Withdraw Colonoscope From Tip of Cecum to Anus.|Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy|2 years||||Time in minutes||Inter-Quartile Range|Median
2783124|NCT00643682|Secondary|Time to Advance Colonoscope From Anus to Tip of Cecum.|time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.|2 years||||time in minutes||Inter-Quartile Range|Median
2783125|NCT00643682|Primary|Boston Bowel Preparation Scale Score|An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922|2 years||||units on a scale||Inter-Quartile Range|Median
2783126|NCT00643604|Secondary|Patient Impression of Change Questionnaire|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.|||participants|||Number
2783127|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
2783128|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
2783129|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
2783130|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
2783131|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
2783132|NCT00643604|Secondary|Change From in Signs and Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline and Week 8||||participants|||Number
2783133|NCT00643604|Secondary|Change in PAH Signs and Symptoms- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||participants|||Number
2783134|NCT00643604|Secondary|Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities|Baseline and Week 8|"Two subjects did not have Week 8 Drug Administration Activity Diaries completed.~Connect Drug and Total Time Components: N=4; One subject did not have data recorded for Connect drug activities. Total time could not be calculated for this subject."|||minutes||Standard Deviation|Mean
2783135|NCT00643604|Secondary|Change in Score on Treatment Satisfaction Questionnaire for Medication|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.|||units on a scale||Standard Deviation|Mean
2786607|NCT00618072|Secondary|Body Weight|Body weight measurement was performed three times and averaged by a single study coordinator.|6 months||||kg||Standard Error|Mean
2783136|NCT00643604|Secondary|Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and Week 8|Two subjects with a Week 8 visit outside of the visit window are included in the summary. One subject died prior to completing the Week 8 visit. One subject had an incomplete Baseline questionnaire and the CAMPHOR Activity component could not be calculated, therefore N=5 Activity and Total Score Components, and N=6 for Symptom and Quality of Life.|||units on a scale||Standard Deviation|Mean
2783137|NCT00643604|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk|The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||units on a scale||Standard Deviation|Mean
2783138|NCT00643604|Secondary|Change in WHO Functional Classification|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||participants|||Number
2783139|NCT00643604|Primary|Change in Six Minute Walk Distance||Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.|||meter||Standard Deviation|Mean
2783140|NCT00643578|Secondary|FEV1|The forced expiratory volume in the first second, expressed as a percent predicted.|1 hour after dose|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.|||percent predicted||Standard Deviation|Mean
2783141|NCT00643578|Primary|Post-dose PC20|The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.|3-7 days after visits 1 and 2|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.|||mg/mL||95% Confidence Interval|Geometric Mean
2783142|NCT00643565|Secondary|Clearance of Bevacizumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL is expressed in milliliters per day (mL/day).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.|||mL/day||Standard Deviation|Mean
2783143|NCT00643565|Secondary|Half-Life of Bevacizumab|Half-life is the time measured for the plasma concentration to decrease by one half.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.|||days||Standard Deviation|Mean
2783144|NCT00643565|Secondary|Volume of Distribution of Bevacizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.|||mL||Standard Deviation|Mean
2783145|NCT00643565|Secondary|Area Under the Curve at Steady State (AUCss) of Bevacizumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg*day/mL).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase|Pharmacokinetic (PK)-evaluable population included all randomized participants for whom at least one blood sample was taken for PK assessment following bevacizumab administration. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mg*day/mL||Standard Deviation|Mean
2783146|NCT00643565|Secondary|Overall Survival Duration|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years)|ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||months||95% Confidence Interval|Median
2783147|NCT00643565|Primary|EFS Duration as Per IRC Assessment|EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years)|ITT population.|||months||95% Confidence Interval|Median
2783148|NCT00643565|Secondary|Percentage of Participants Who Died||Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years.|ITT population.|||percentage of participants|||Number
2783437|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783151|NCT00643565|Secondary|Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria|Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions >/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.|Screening up to approximately 6.75 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
2783152|NCT00643565|Primary|Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment|EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years)|ITT population.|||percentage of participants|||Number
2783153|NCT00643487|Primary|Number of Participants With Successful Recording.|Observe the behavior of the IPP of the knee by fluoroscopy. A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized. The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.|During procedure, on average one hour.||||Participants|||Number
2783154|NCT00643448|Secondary|Compliance With Trans Telephonic Monitoring (TTM)|Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis|During treatment days 1-10||||Percentage of recordings analysed||Full Range|Mean
2783155|NCT00643448|Secondary|Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state|Population PK model parameter estimates derived from plasma concentrations of AZD1305|During treatment days 1-10||||μmol/L||Full Range|Mean
2783156|NCT00643448|Secondary|Adverse Events (AE)|Number of patients who had at least one AE according to the definition in the study protocol|During treatment days 2-10||||Participants|||Number
2783157|NCT00643448|Primary|Maximum QTcF|Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.|During treatment days 2-10||||ms||Full Range|Mean
2783158|NCT00643279|Secondary|Distance Walked During a Six Minute Hall Walk|Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.|6 Months post-implant|All randomized patients completing a hall walk at baseline and 6 months.|||Meters||Standard Deviation|Mean
2783159|NCT00643279|Secondary|New York Heart Association (NYHA) Class|"New York Heart Association (NYHA) Classifications were defined as follows:~Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina.~Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.~Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.~Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 Months post-implant|All randomized subjects with NYHA assessment completed at baseline and at 6 months were included in the analysis|||Participants|||Count of Participants
2783160|NCT00643279|Secondary|Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire|"Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life).~Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis."|6 Months post-implant|All randomized subjects completing a quality of life survey at the baseline visit and month 6 visit|||Index score||Full Range|Mean
2783161|NCT00643279|Secondary|"Clinical Composite Response of Either Worsened, Improved, or Unchanged"|"Worsened, Improved and Unchanged were defined as follows:~Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened."|6 Months post-implant|All randomized subjects|||Participants|||Count of Participants
2783162|NCT00643279|Secondary|Days Hospitalization Free|The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period.|6 Months post-implant|All randomized subjects|||Days||95% Confidence Interval|Mean
2783163|NCT00643279|Secondary|Health Care Utilization|Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.|6 Months post-implant|All randomized subjects|||Total number of events|||Number
2783164|NCT00643279|Primary|Rate of Heart Failure-related Hospital Equivalents.|"Hospital equivalents (HE) were defined to include the following events:~Heart failure-related hospital admissions for 24 hours or longer~Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration).~Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration)."|6 Months post-implant|All randomized subjects|||Events||95% Confidence Interval|Mean
2783537|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/min||Standard Deviation|Mean
2783166|NCT00643279|Primary|Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.|"A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system.~Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months."|Within 6 months post-implant|The analysis population for safety includes all subjects with an attempted implant of the Chronicle implantable hemodynamic monitoring device, including both successful implanted participants (274) and unsuccessful implanted participants (3). In total 277 participants were assessed for the safety objective.|||Participants|||Count of Participants
2783167|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests|All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
2783168|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
2783169|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
2783170|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
2783171|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.|||participants|||Number
2783172|NCT00643201|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants|Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued|Total number of participants receiving at least one dose of study drug. Participants were categorized according to the actual treatment received.|||participants|||Number
2783202|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Percentage of participants|||Number
2783173|NCT00643201|Secondary|Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 402/2676; 676/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2783174|NCT00643201|Secondary|Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 313/2676; 505/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2783175|NCT00643201|Secondary|Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 103/2676; 215/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2783176|NCT00643201|Secondary|Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants|Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 115/2676; 261/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2783177|NCT00643201|Secondary|Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants|All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 15/2676; 49/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2783178|NCT00643201|Secondary|Incidence of All-Cause Death During the Intended Treatment Period|Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants excluding those with missing endpoint (n/N: 41/2608; 52/2630). Events included regardless of whether or not participant received treatment, ie, ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783438|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783179|NCT00643201|Secondary|Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective groups excluding those with missing endpoint information (n/N: 15/2608; 23/2630). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783180|NCT00643201|Secondary|Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective treatment groups excluding participants with missing endpoint information. (n/N: 12/2608; 16/2630). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783181|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period|PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 27/2606; 25/2632). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783182|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period|DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 22/2608; 35/2633). CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783183|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding|VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number participants in each treatment group, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 183/2617; 333/2641). Events included as per ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783184|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 73/2610; 118/2635). Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783185|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 61/2609; 77/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. CI for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783186|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 84/2609; 104/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783187|NCT00643201|Primary|Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment|VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).|Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)|All randomized participants with a non-missing primary endpoint (n/N: 59/2609; 71/2635, in apixaban, enoxaparin/warfarin, respectively). Intent-to-treat population. Confidence interval (CI) for event rate calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2783188|NCT00643162|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Score|The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of anxiety before, during, and after treatment. The HAM-A is a 14-item assessment and each item is scored on a 5-point scale, ranging from 0 = not present to 4 = very severe. The sum of the scores is: 0-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 = severe anxiety, and >30 = very severe anxiety.|9 weeks|Data was not abstracted since interim analysis recommended study closure|||units on a scale||Standard Deviation|Mean
2783189|NCT00643162|Secondary|Change in Beck Depression Inventory Score|The Beck Depression Inventory (BDI) is a series of 21-question, self-report rating inventory developed at a 5th grade reading level that measures characteristic attitudes and symptoms of depression. It was develop to detect, assess and monitor changes in depressive symptoms. For people who have been clinically diagnosed with depression, scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.|9 weeks|Data was not abstracted since interim analysis recommended study closure|||units on a scale||Standard Deviation|Mean
2783190|NCT00643162|Primary|Change in Hamilton Depression Scale (HAM-D) Score|The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of depression before, during, and after treatment. The HAM-D form lists 21 items, but the scoring is based on the first 17 questions. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The scores from each item are added together to provide a total score. The sum of the scores from the first 17 questions provides an indication for level of depression. 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and ≥ 23=very severe depression.|9 weeks|A 7th Massage subject completed 6 of 7 visits so his data was carried forward to the final visit. Data from the LT subject who terminated early at Visit 3 was not used. An interim analysis was performed, there was one active subject still in the early stages of the protocol, whose data was not included. The interim analysis became final.|||units on a scale||Standard Deviation|Mean
2783203|NCT00642993|Primary|Mean Change From Baseline in Body Weight at Week 12|Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Kilogram||Standard Error|Mean
2783191|NCT00643123|Secondary|Hamilton Depression Scale (HAM-D)|"The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of depression before, during, and after treatment. A 28-item HAM-D form was used but only the first 17 questions are used in the assessment for depression. Of the first 17 questions, eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The sum of the scores from the first 17 questions is: 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and ≥ 23=very severe depression.~Questions 18-28 are scored similarly and assess sleep disorders, paranoid behavior, motor dysfunction, psychosis, and weight gain, etc."|7 weeks|No data displayed because no data was collected prior to closing of the research unit.||||||
2783192|NCT00643123|Primary|Young Mania Rating Scale (YMRS)|"The YMRS is an 11-item, clinician-administered rating scale to assess the severity of manic symptoms before, during and after treatment. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. A score of 0 indicates the behavior is absent, whereas a score of 4 or 8 indicates the behavior is present and severe.~The change in score between Baseline and the Completion Visit will be reported. Ideally, the two time points will be Baseline and 6 Weeks after Baseline, but, if a subject terminates early, his/her last YMRS score will be carried forward to the final visit.~The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms. A score of 0-12 indicates the absence of mania or a very mild manic state, a score of 13-20 or higher indicates a mild man"|7 weeks (Baseline and 6 weeks (or last visit date) after baseline|27 subjects were randomized but 4 (3 from the Treatment group and 1 from the Control group) withdrew from the study immediately following the baseline visit. Therefore, a second time point was unavailable for these subjects.|||units on a scale||Standard Error|Mean
2783193|NCT00643097|Secondary|Toxicity to PEP-3 Vaccine Immunization|To assess for any potential toxicity to the PEP-3 vaccine immunization in patients with newly diagnosed glioblastoma, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to tabulate any toxicities attributable to PEP-3. The number of patients with toxicity attributable to vaccine while on study are tabulated.|26 months||||participants|||Number
2783194|NCT00643097|Secondary|Response to Vaccination|The objective is to assess the duration of immunosuppressive cytokine secretion and to identify a receptive interval for active immunotherapy. Immunosuppression will determined by monitoring a panel of immunosuppressive serum/plasma cytokines longitudinally and by determining the response of each patient to Recombivax Hepatitis B (HB) vaccination. Response is defined as seropositive or seronegative to the Hepatitis B surface antigen.|26 months|This objective was not completed, as the test was not performed successfully.|||Months||Standard Deviation|Mean
2783195|NCT00643097|Primary|Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS)|"Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.~Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator)."|58 months||||months||95% Confidence Interval|Median
2783196|NCT00643097|Primary|Humoral and Cellular Immune Response|Number of patients that developed a delayed-type hypersensitivity (DTH) response at following vaccination. Any skin reaction in response to the intradermal injection of the antigen was measured and recorded. A positive skin test was defined as > 5 mm induration (swelling).|26 months|The test was performed on a subset of patients in each group that were available at vaccine 8, and results posted for those 30 patients who had the tests performed.|||participants|||Number
2783197|NCT00643006|Primary|Change of Pain Level From Baseline.|Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.|15 weeks|Patients attending at post-test|||mm||Standard Deviation|Mean
2783198|NCT00643006|Primary|Six-minute Walk Test|Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.|15 weeks||||meter||Standard Deviation|Mean
2783199|NCT00642993|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at Week 12|"For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.~Per protocol, participants were either obese (BMI ≥30 kg/m^2 and ≤40 kg/m^2) or overweight (BMI ≥27 kg/m^2 and <30 kg/m^2) at enrollment."|Baeline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||kg/m^2||Standard Error|Mean
2783200|NCT00642993|Secondary|Mean Change From Baseline in Waist Circumference at Week 12|Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Centimeters||Standard Error|Mean
2783201|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.|||Percentage of participants|||Number
2783238|NCT00642694|Primary|Percentage of Remitters on IDS-C30 at Week 12|Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity|12 Weeks|Participants who were randomized to treatment and completed Week 12 were included in analyses|||percentage of participants|||Number
2783204|NCT00642902|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.|From the first dose of study drug administration up to 12 weeks after the last dose of the study drug|Safety population included all participants who received at least 1 dose of treatment (either active or placebo).|||participants|||Number
2783205|NCT00642902|Secondary|Percentage of Participants Free From Relapses|A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.|Baseline up to Week 36|ITT population included all randomized participants.|||percentage of participants|||Number
2783206|NCT00642902|Secondary|Number of New T1 Gd-enhancing Lesions Per Participant|Analysis of new T1 Gd-enhancing lesions was done using MRI scans.|Weeks 12, 24, 36|ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively.|||lesions/participant||Standard Deviation|Mean
2783207|NCT00642902|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan|Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).|Weeks 12 to 36|ITT population included all randomized participants.|||lesions/participant/scan||95% Confidence Interval|Mean
2783208|NCT00642850|Secondary|Number of Participants With Anti-epoetin Antibody||Week -4 and at early withdrawal or Week 28|ITT Population.|||participants|||Number
2783209|NCT00642850|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 28|ITT Population.|||participants|||Number
2783210|NCT00642850|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 to Week 16 and Week 17 to Week 24|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable for specified category.|||percentage of participants|||Number
2783211|NCT00642850|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.|||days||Standard Deviation|Mean
2783212|NCT00642850|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2783213|NCT00642850|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week -1 and Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who had received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least 1 follow-up variable had been available.|||g/dL||Standard Deviation|Mean
2783214|NCT00642850|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24.|||percentage of participants||95% Confidence Interval|Number
2783215|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
2783300|NCT00642304|Secondary|Mean Change in Hb Concentration Between SVP and the EEP|The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|ITT population|||g/dL||Standard Deviation|Mean
2783216|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
2783217|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
2783218|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percent||95% Confidence Interval|Least Squares Mean
2783219|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.|The secondary definition of response to treatment is IPA >50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14, and day 28, 4 hours post dose|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.|||Percent of participants|||Number
2783220|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)|The primary definition of response to treatment is IPA >10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14 and Day 28, 4 Hrs Post Dose.|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.|||Percent of Participants|||Number
2783221|NCT00642772|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.|Baseline and Following 12-Week Intervention||||units on a scale||Standard Deviation|Mean
2783222|NCT00642759|Secondary|Overall Survival|The median overall survival in months|3 years||||Months||95% Confidence Interval|Median
2783223|NCT00642759|Secondary|6 Month Survival Rate|The percentage of participants surviving at least six months after baseline|6 months||||percentage of participants surviving||95% Confidence Interval|Number
2783224|NCT00642759|Secondary|Objective Response Rate to Carboplatin, Abraxane and Avastin|Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors [Version 1.0]|3 years||||Participants|||Count of Participants
2783225|NCT00642759|Primary|6-month Progression Free Survival Rate|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 Months||||percentage of participants||95% Confidence Interval|Number
2783226|NCT00642746|Secondary|Time to Second Progression (From Start of First-Line Regimen)|"Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.~Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed."|Documented by Follow-up CT scans following first line treatment, average of 225 days.|95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient.|||Days||95% Confidence Interval|Median
2783538|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783227|NCT00642746|Secondary|Second-line Progression Free Survival|Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.|"Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.~95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient."|||Days||95% Confidence Interval|Median
2783228|NCT00642746|Primary|Response Rates of Radiographically Measurable Disease|The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.|Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.|||Number of Patients|||Number
2783229|NCT00642707|Primary|Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.|||Log10copies/HIV-1 RNA/mL||Standard Deviation|Mean
2783230|NCT00642694|Secondary|Hamilton Rating Scale for Depression 17-item|The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the clinician on either a 3- or a 5 point scale. Total scores range from 0-52, with higher scores indicating greater depressive symptoms.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||score on a scale||Standard Deviation|Mean
2783231|NCT00642694|Secondary|Patient Perception of Benefits of Care (PPBC)|The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will improve quality of life.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||score on a scale||Standard Deviation|Mean
2783232|NCT00642694|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI)|The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with higher scores indicating greater impairment. Scores are multiplied by 10 to obtain percent impairment.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||percentage of time activity was impaired||Standard Deviation|Mean
2783233|NCT00642694|Secondary|Work and Social Adjustment Scale (WSAS)|The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-40, with higher scores indicating worse functioning.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||score on a scale||Standard Deviation|Mean
2783234|NCT00642694|Secondary|Social Adjustment Scale - Self-Report (SAS-SR)|The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating greater impairment.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||mean score on a scale||Standard Deviation|Mean
2783235|NCT00642694|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and ranges from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||score on a scale||Standard Deviation|Mean
2783236|NCT00642694|Secondary|Short-Form Health Survey - Version 2 (SF-36)|The Short-Form Health Survey - version 2 (SF-36) is a self-report inventory measuring different domains of health-related quality of life: Physical Functioning, Physical Role Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Functioning, and Mental Health. Scores range from 0 to 100, with higher scores indicating better perceived health and functioning.|12 Weeks|Please note that the study was terminated early and may be underpowered to perform these analyses; results should be interpreted with caution.|||score on a scale||Standard Deviation|Mean
2783237|NCT00642694|Secondary|Sleep Latency|Number of minutes until fell asleep|12 weeks|Number of Participants with analyzable data for this outcome measure|||minutes||Standard Deviation|Mean
2783439|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate|Number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783239|NCT00642668|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Weeks 1-40|The safety population included all participants who received at least one dose of active drug.|||percentage of participants|||Number
2783240|NCT00642668|Secondary|Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.|||days||Standard Deviation|Mean
2783241|NCT00642668|Secondary|Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.|||percentage of participants||95% Confidence Interval|Number
2783242|NCT00642668|Secondary|Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)|The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.|Weeks 0-36|ITT population included all participants who entered the titration period and received active drug.|||grams/deciliter (g/dL)||Standard Deviation|Mean
2783243|NCT00642668|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range|The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.|Weeks 29-36|Intent-to-Treat (ITT) population included all participants who entered the titration period and received active drug.|||percentage of participants||95% Confidence Interval|Number
2783244|NCT00642642|Secondary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Analysis was performed on the ITT population|||Cheeks|||Number
2783245|NCT00642642|Secondary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Number of cheeks for analysis was the ITT population|||Participants|||Number
2783246|NCT00642642|Primary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) and four months after last treatment|Analysis was performed on the ITT population|||Cheeks|||Number
2783247|NCT00642642|Primary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) and four months after last treatment|Analysis population was the ITT population, defined as subjects for whom product could be produced and who were randomized to study treatment, whether or not all study treatments are actually received.|||Participants|||Number
2783248|NCT00642616|Secondary|Change in HbA1C From Baseline to Week 52||Baseline, week 52|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns||||||
2783249|NCT00642616|Secondary|Number of Participants With COPD Exacerbation by Treatment Arm|Number of participants who experienced worsening of COPD symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying COPD|||participants|||Number
2783250|NCT00642616|Secondary|Number of Participants With Asthma Exacerbation by Treatment Arm|Number of participants who experienced worsening of asthma symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying Asthma|||participants|||Number
2783251|NCT00642616|Primary|Change in Post-bronchodilator FEV1 From Baseline to Week 52|Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.|52 Weeks|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns.||||||
2783252|NCT00642603|Primary|Progression-free Survival (PFS) in U.S. Patients Only|PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.|From first patient enrolled up to approximately 48 months|This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.||||||
2783253|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4|Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 4 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.|||percentage of participants|||Number
2783262|NCT00642460|Secondary|Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.~Baseline considered first dose of study treatment."|Every 2 weeks from Week 104 to Week 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783254|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2|Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 2 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.|||percentage of participants|||Number
2783255|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783256|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783257|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783258|NCT00642460|Secondary|Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783259|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783260|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission|"Patients who previously withdrew are excluded Responders are patients who met all of the following criteria for inactive disease at all visits in the 6 months (180 days) prior to and including the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.~iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex.~vi. iv. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. ESR = Erythrocyte Sedimentation Rate. VAS = Visual Analogue Scale. Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783261|NCT00642460|Secondary|Part III: Percentage of Participants With Inactive Disease|"Participants who previously withdrew are excluded.~Responders are participants who met all of the following criteria for inactive disease at the visit assessment day:~i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.~iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA.~v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex. vi. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS.~Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783321|NCT00642018|Secondary|Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)||Predose up to 8 hours postdose in Cycle 1|All randomized participants who received at least one dose of the study drug and had pharmacokinetics data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2783263|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.~Baseline considered first dose of study treatment. Data presented up to entry into the Alternative Dosing Schedule."|Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|ITT3 population; n=number of participants contributing to the specific statistic|||percentage of participants|||Number
2783264|NCT00642460|Secondary|Part III: Doses of Oral Corticosteroids|Oral corticosteroid values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the the visit of withdrawal and all subsequent visits.|Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|ITT3 population; n=number of participants contributing to the specific statistic|||mg/kg/day||Standard Deviation|Mean
2783265|NCT00642460|Secondary|Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week|JIA ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III ITT3 population|||percentage of participants|||Number
2783266|NCT00642460|Secondary|Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR|Percentage of participants with ≥30%, 50%, 70%, and 90% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III intent-to-treat (ITT3) population consists of all participants who entered into Part III of the study and received at least one administration of tocilizumab during Part III.|||percentage of participants|||Number
2783267|NCT00642460|Secondary|Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104|"Rate of SAEs, Rate of Serious Infection AEs, Rate of Related SAEs (remotely, possibly, probably) to Tocilizumab (TCZ), Rate of Macrophage Activation Syndrome, Rate of AEs leading to withdrawal and Rate of deaths per 100 patient years (PY) were calculated using the formula:~Number of Patient Events / Duration in study (years) * 100.~Multiple occurrences of the same AE in one individual are counted."|104 Weeks|Safety Population- all participants who received at least one dose of study drug and had 1 post-baseline safety assessment. Includes all safety data in the database up to the week 104 infusion based on the date of randomization for each patient. (Last date was 31 May 2011)|||Events per 100 patient year|||Number
2783268|NCT00642460|Secondary|Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104|Percentage is based on only those participants who were on oral corticosteroid at baseline and reached a nominal visit day on which dose was calculated.|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.|||Percentage of Participants|||Number
2783269|NCT00642460|Secondary|Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).~The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.|||Score on a scale||Standard Deviation|Mean
2783270|NCT00642460|Secondary|Part II: Percentage of Participants With Inactive Disease at Week 104|"Criteria for Inactive Disease:~1) No joints with active arthritis, 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal Erythrocyte Sedimentation Rate (<20 mm/hour), 4) Physician's global assessment of disease activity Visual Analog Scale (VAS) indicates no disease activity (where no disease activity is considered to be a score ≤10 mm on a 100 mm VAS)."|Week 104|Participants from the Intent to Treat population who reached time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been nonresponders.|||Percentage of Participants|||Number
2783271|NCT00642460|Secondary|Part II: Percentage of Participants With no Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The percentage of participants with no signs of active arthritis is reported.|Week 104|The Intent to Treat population in Part II includes 112 participants who received at least one dose of study drug. Only those participants who reached this time point are included in the analyses.|||Percentage of Participants|||Number
2783272|NCT00642460|Secondary|Part II: Number of Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The mean number of joints with signs of active arthritis is reported.|Week 104|Participants from the Intent to Treat population who reached this time point. No data imputation is applied and patients with missing data are excluded.|||Active Joints||Standard Deviation|Mean
2783283|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement|The maximum number of joints with limitation of movement is 67 and these are defined as those in the joint assessment with 'limitation of motion'.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
2783337|NCT00641797|Primary|Likert Scale for Satisfaction|The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).|0 days||||units on a scale||Standard Deviation|Mean
2783273|NCT00642460|Secondary|Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104|"The six JIA ACR components consist of: 1)Physician's global assessment of disease activity, 2)Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.~At an assessment visit a JIA ACR70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 104|Participants from the Intent to Treat population who reached the time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been non-responders.|||Percentage of Participants|||Number
2783274|NCT00642460|Secondary|Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12|Part I: Percentage of patients who had anemia (hemoglobin <lower level normal based on sex and age) at Baseline and a ≥10 g/L increase in hemoglobin at Week 6 and at Week 12.|Baseline, Week 6 and Week 12|"Participants from the Intent-to-treat population for whom hemoglobin data available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.~LOCF rule applied to missing hemoglobin values at Week 6 and Week 12."|||Percentage of participants|||Number
2783275|NCT00642460|Secondary|Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12|Percentage of participants who had a rash characteristic of sJIA in the 14 days prior to the baseline visit but no rash characteristic of sJIA in the 14 days preceding the Week 12 visit day.|Baseline, Week 12|Participants from the Intent-to-treat population for whom data was available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.|||Percentage of participants|||Number
2783276|NCT00642460|Secondary|Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12|"Percentage of patients who had at least a 0.13 improvement in CHAQ-DI score from Baseline to Week 12.~The CHAQ-DI questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do)."|Baseline, Week 12|"Intent-to-treat Population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.~LOCF rule applied to missing CHAQ-DI Scores at Week 12."|||Percentage of participants|||Number
2783277|NCT00642460|Secondary|Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12|Participants rated their pain by placing a horizontal line on a Visual Analog Scale on a scale of 0 (no pain)- 100 mm (severe pain). The score at 12 weeks minus the score at baseline. A negative number indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population who had Pain VAS data available at baseline and week 12. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing pain VAS at Week 12.|||mm|||Number
2783278|NCT00642460|Secondary|Part I: Percentage of Participants With Concomitant Corticosteroid Reduction|"The percentage of participants receiving oral corticosteroids(CS) with a JIA ACR70 response at week 6 or Week 8 who reduced their oral CS dose by at least 20% without subsequent JIA ACR30 flare or occurrence of systemic symptoms at week 12.~At an assessment visit a JIA ACR70 response is defined as: At least three of the six JIA ACR core components improving by at least 70% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Week 6 or Week 8, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who were taking oral corticosteroids.|||Percentage of participants|||Number
2783279|NCT00642460|Secondary|Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12|Percentage of participants with a change from an elevated hsCRP value at baseline to a normal hsCRP value at week 12; a change from anemia (low Hemoglobin) at baseline to a normal hemoglobin value at week 12; a change from thrombocytosis (elevated platelets) at baseline to a normal platelet value at week 12; a change from leukocytosis (elevated white blood cell count) at baseline to a normal white blood cell count at week 12.|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug. 'n' in each of the categories is the number of participants with data available at baseline and week 12 for analyses.|||Percentage of participants|||Number
2783280|NCT00642460|Secondary|Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12|Fever free was defined as no diary temperature recording ≥37.5° Celsius in the preceding fourteen days.|Baseline, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who had a fever due to Systemic Juvenile Idiopathic Arthritis at baseline.|||Percentage of participants|||Number
2783281|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).~The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
2783282|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured in mm/hour.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
2783338|NCT00641745|Primary|Number of Participants With Adverse Events.||12 months||||participants|||Number
2783284|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis|"The maximum number of joints with active arthritis is 71 and these are defined as those in the joint assessment with: swelling present or pain present and limitation of motion.~The joint assessment is performed by an independent assessor, who is not the treating physician, blinded to all other aspects of the patient's efficacy and safety data."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
2783285|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being|The Parent/Patient global assessment of overall well-being is a VAS. The scale is a 0 to 100 mm horizontal scale, the extreme left end of the line represents 'very well' (i.e. symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (i.e. maximum arthritis disease activity). This item is completed by the patient or parent/guardian as appropriate.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
2783286|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity|Physician's Global Assessment of disease activity is a Visual Analog Scale. The scale is 0 to 100 mm horizontal scale, the extreme left end of the line represents 'arthritis inactive' (i.e. symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. This item is completed by the treating physician.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. Last observation carried forward (LOCF) rule applied to missing JIA ACR core set components at Week 12.|||Percentage change|||Number
2783287|NCT00642460|Secondary|Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12|"The six JIA ACR components consist of: 1) Physician's global assessment of disease activity, 2) Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.~At an assessment visit a JIA ACR30/50/70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 30%/50%/70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2783288|NCT00642460|Primary|Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104|Percentage of participants with ≥20 percent, ≥50 percent, ≥75 percent and ≥90 percent decreases in oral corticosteroid dose (mg/kg/day) from baseline.|Baseline, Week 104|Includes only participants on oral corticosteroids at baseline.|||Percentage of participants|||Number
2783289|NCT00642460|Primary|Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever|"Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains.~Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days."|Baseline, Week 12|Intent-to-treat population includes all participants who had at least one dose of study drug.|||Percentage of participants|||Number
2783290|NCT00642382|Secondary|Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis.||At 4, 12 and 26 weeks post 3rd injection|||||||
2783291|NCT00642382|Primary|The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.||At 4, 12 and 26 weeks post 3rd injection|Zero patients were analyzed for this study due to the study being closed 2 months after it started. Data were not collected||||||
2783292|NCT00642369|Primary|Percentage of Rapid Eye Movement Sleep|The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).|28 days|For the need of the statistical analysis, the study group and the control group are 30 evaluable patients respectively. Finally, in consideration of 25% un-evaluable patients after randomisation, there should be 80 patients randomised in this study with 40 patients per arm.|||percentage of rapid eye movement sleep||Standard Deviation|Mean
2783293|NCT00642369|Primary|Percentage of Slow Wave Sleep|The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).|28 days||||percentage of slow wave sleep||Standard Deviation|Mean
2783294|NCT00642356|Secondary|Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|"The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from not present to very severe. The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement."|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy|||Units on a scale||Standard Deviation|Mean
2783295|NCT00642356|Primary|Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|"The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from not present to very severe. The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement."|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy|||Units on a scale||Standard Deviation|Mean
2783604|NCT00640224|Secondary|Delta DHEA at Baseline and 6 Months|Delta DHEA was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ug/dL||Standard Error|Mean
2783301|NCT00642304|Primary|Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)|The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.|EEP (Weeks 16 to 24)|The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.|||Percentage of participants||95% Confidence Interval|Number
2783302|NCT00642278|Secondary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Deviation|Mean
2783303|NCT00642278|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||kg||Standard Deviation|Mean
2783304|NCT00642278|Secondary|Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12|The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||mg/mg||Standard Deviation|Mean
2783305|NCT00642278|Secondary|Percentage of Patients With Symptoms of Hypoglycemia|The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.|Up to Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomiy assigned to a treatment group.|||Percentage of patients|||Number
2783306|NCT00642278|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12|The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||mmol/L||Standard Deviation|Mean
2783307|NCT00642278|Primary|Change in HbA1c From Baseline to Week 12|The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent||Standard Deviation|Mean
2783308|NCT00642174|Secondary|Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate|Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) - Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Inhibition of Platelet Function (IPF) as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP), who met compliance criteria, and who had last dose of study drug prior to blood draw for IPF.|||millimeters (mm)||95% Confidence Interval|Least Squares Mean
2783309|NCT00642174|Secondary|Platelet Reactivity Index (PRI)|Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Vasodilator-Associated Stimulated Phosphoprotein (VASP), who met compliance criteria, and who had last dose of study drug prior to the blood draw for inhibition of platelet function as assessed by VASP.|||percent inhibition||95% Confidence Interval|Least Squares Mean
2783310|NCT00642174|Secondary|Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)|Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for MPA.|||percent platelet aggregation||95% Confidence Interval|Least Squares Mean
2783311|NCT00642174|Secondary|Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay|Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD)|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.|||percent inhibition||95% Confidence Interval|Least Squares Mean
2783312|NCT00642174|Primary|Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay|The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|4 hours after loading dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA at 4 hours, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.|||percent inhibition||95% Confidence Interval|Least Squares Mean
2783313|NCT00642018|Other Pre-specified|Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment||Study treatment discontinuation up to 30 days post study treatment discontinuation|All randomized participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2783314|NCT00642018|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)|The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms.|3 months|All randomized participants who received at least one dose of study drug and had FACT-G assessment at 3 months.|||units on a scale||Inter-Quartile Range|Median
2783315|NCT00642018|Secondary|Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)|The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms.|3 months|All randomized participants who received at least one dose of study drug and had FACT-P assessment at 3 months.|||units on a scale||Inter-Quartile Range|Median
2783316|NCT00642018|Secondary|Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)|G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline.|Baseline, 21 days|All randomized participants who received at least one dose of study drug and had G-CSF measurement at baseline and 21 days.|||percentage change|||Number
2783317|NCT00642018|Secondary|Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)|Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease up to 41.00 months|All randomized participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2783318|NCT00642018|Secondary|Estimate Duration of Overall Response|The duration of response [complete response (CR) or partial response (PR)] was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact.|Time of response to time of measured progressive disease up to 41.00 months|All randomized participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR). The numbers of participants censored were 3 (Docetaxel group) and 1 (LY2181308 + Docetaxel group).|||months||90% Confidence Interval|Median
2783319|NCT00642018|Secondary|Estimate Overall Survival|Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug.|First treatment to death due to any cause up to 45.54 months|All randomized participants who received at least one dose of study drug. The numbers of participants censored were 25 (Docetaxel group) and 49 (LY2181308 + Docetaxel group).|||months||90% Confidence Interval|Median
2783320|NCT00642018|Secondary|Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)|PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated.|Baseline, 18 months|All randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2795561|NCT00552695|Primary|Pain on Visual Analog Scale (VAS)|Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).|0 MINUTES||||mm||Inter-Quartile Range|Median
2783322|NCT00642018|Secondary|Adverse Event Profile|Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.|First treatment dose up to 19 months|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2783323|NCT00642018|Primary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.|First treatment dose up to 19 months|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2783324|NCT00642018|Primary|Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone|PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.|Baseline to measured progressive disease or death due to any cause up to 44.68 months|All randomized participants who received at least one dose of the study drug. The numbers of participants censored were 10 (Docetaxel group) and 22 (LY2181308 + Docetaxel group).|||months||90% Confidence Interval|Median
2783325|NCT00641862|Secondary|Bradley Infant-Toddler Home Tools|Home tools used to analyze aspects of home environment. This scale captures information on parenting behavior under 6 domains: responsivity, acceptance, organization, learning materials, parental involvement, and variety of stimulation at home). Trained study personnel will administer this questionnaire to participating families at 60 months.|60 months|||||||
2783326|NCT00641862|Secondary|Parental Version of Strengths and Difficulties Questionnaire (SDQ)|Administered at 78 months to assess childhood behavioral problems. The SDQ has 25 items and generates 5 scales: emotional problem, conduct problem, hyperactivity/inattention, peer relationship problems and pro-social behavior.|78 months|||||||
2783327|NCT00641862|Secondary|The Brief P Test|The Brief P test is a measure of infant executive function based on parental rating. It will be administered at 66 months postpartum.|66 months postpartum|||||||
2783328|NCT00641862|Secondary|Vineland Social Maturity Scale (VSMS)|This scale has 8 main domains which include, Self Help General, Self Help Dressing, Self Direction, Occupation, Communication, Locomotion and Socialization. It is possible to calculate Social age and Social quotient from VSMS which will provide a good idea about the social maturity of the infant. VSMS will be used in conjunction with KABC at age 60-72 months of age.|60-72 months|||||||
2783329|NCT00641862|Secondary|The Wechsler Preschool and Primary Scale of Intelligence (WPPSI)|WPPSI is an intelligence test designed for children ages 2 years 6 months to 7 years 7 months. It is a paper-pencil test that will be administered during the 78 month follow up to assess child's intellectual functioning.|78 months|||||||
2783330|NCT00641862|Secondary|Kaufman's Assessment Battery for Children (KABC)|This test is used for assessing child intelligence|60-72 months|||||||
2783331|NCT00641862|Secondary|Gross Motor Scale, Bayley Scales of Infant Development, 3rd Edition|The Gross Motor Scale is a single scale that measures movement of the limbs and torso, static positioning (e.g., sitting, standing), dynamic movement including locomotion and coordination, balance, and motor planning. Higher values represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible value is 0 and the maxiumum possible value is 72.|9 months|This outcome was measured in 178 of the 366 enrolled participants|||units on a scale||Inter-Quartile Range|Median
2783332|NCT00641862|Secondary|Fine Motor Scale, Bayley Scales of Infant Development, 3rd Edition|The Fine Motor Scale is a single scale that measures prehension, perceptual-motor integration, motor planning and speed, visual tracking, reaching, object grasping, object manipulation, functional hand skills, and responses to tactile information. Higher values represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible value is 0 and the maximum possible value is 66.|9 months|This outcome was measured in 178 of the original 366 participants|||units on a scale||Inter-Quartile Range|Median
2783333|NCT00641862|Secondary|Expressive Language Scale, Bayley Scales of Infant Development, 3rd Edition|The Expressive Language Scale is a single scale that measures the ability of the child to communicate using sounds, gestures, or words. Higher scores represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible value is 0 and the maximum possible value is 48.|9 months|This outcome was measured in 178 of the 366 enrolled participants|||units on a scale||Inter-Quartile Range|Median
2783334|NCT00641862|Secondary|Receptive Language Scale, Bayley Scales of Infant Development, 3rd Edition|The Receptive Language Scale is a single scale that measures the ability of the child to recognize sounds and understand spoken words and directions. Higher values represent better performance. The interquartile range provides adequate assessment of the variability of the data. The minimum possible score is 0 and the maximum possible score is 49.|9 months|This outcome was measured among 178 of the 366 enrolled participants.|||units on a scale||Inter-Quartile Range|Median
2783335|NCT00641862|Secondary|Cognitive Scale, Bayley Scales of Infant Development, 3rd Edition|The cognitive scale is a single scale that measures sensorimotor integration, concept formation, attention, habituation, and memory. Higher values represent better performance. The interquartile range provides an adequate assessment of the variability of the data. The minimum possible score of the cognitive scale is 0 and the maximum possible score is 91.|9 months|Outcome was measured among 178 of the 366 enrolled participants.|||units on a scale||Inter-Quartile Range|Median
2783336|NCT00641862|Primary|Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester||from 1st to 3rd trimester|Serum samples were available for analysis among 102 of the original 183 participants in each arm.|||pmol/L||Inter-Quartile Range|Median
2783339|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783340|NCT00641719|Secondary|Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783341|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783342|NCT00641719|Secondary|Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783343|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783344|NCT00641719|Secondary|Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783345|NCT00641719|Secondary|Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783346|NCT00641719|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.|||units on a scale||Standard Deviation|Mean
2783347|NCT00641719|Primary|Number of Participants Who Experienced an Adverse Event (AE)|See the Reported Adverse Events section for details.|baseline through 1 year|All participants who received at least 1 dose of study drug.|||participants|||Number
2783348|NCT00641706|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations|"Confidence intervals for the true proportion will be calculated using the exact binomial method.~Measurable patients must achieve at least a 50% reduction in the product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Evaluable patients must achieve unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|Arm A patients that started treatment. Arm B patients were not analyzed for this outcome because they received surgery and hence response was not measured.|||proportion of patients||95% Confidence Interval|Number
2783349|NCT00641706|Secondary|Time to Progression|Estimated using Kaplan-Meier survival curve. Patients who died were considered to have disease progression at the time of death unless there was documented evidence that no progression occurred before death. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|From study registration to date of progression (up to 5 years)|Patients that started treatment.|||months||Full Range|Median
2783351|NCT00641706|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|At 6 months|Patients that started treatment.|||percentage of patients|||Number
2783352|NCT00641667|Secondary|Number of Participants With Response Based on Physician's Global Assessment Scale|The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.|||Participants|||Number
2783353|NCT00641667|Secondary|Mean Number of Rescue Doses|Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Rescue Doses||Standard Deviation|Mean
2783354|NCT00641667|Secondary|Number of Participants With Total Duration of Pain Per Day|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783355|NCT00641667|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783356|NCT00641667|Secondary|Pain Intensity Visual Analog Scale (VAS) Score|"Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as no pain and the right edge (100 mm) defined as severest pain conceivable."|Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
2783357|NCT00641667|Secondary|Number of Participants With Response Based on Patient's Global Assessment Scale|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
2783358|NCT00641667|Primary|Percentage of Participants Achieving Pain Control|Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.|Day 10 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.|||Percentage of Participants||95% Confidence Interval|Number
2783359|NCT00641641|Primary|Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)|change was calculated as the mean of 12 assessments minus the baseline value|12 times within 48 weeks.|Intention to treat|||log copies/mL plasma||Standard Deviation|Mean
2783360|NCT00641563|Secondary|BIS-Index Awake and 3 Sedation Levels (RS 2/3/4)|BIS-Index is a dimensionless value ranging from 0-100, indicating fully awake at 100 and a flat-line electroencephalogram at 0. Standard anesthesia creates a BIS-Index range 40-60. The scale is ordinal, not interval. BIS Index is calculated from the EEG by a proprietary algorithm (Aspect Medical Inc.)|awake and 3 sedation levels (RS 2/3/4) 20 min each||||Units on a scale||Standard Deviation|Mean
2783361|NCT00641563|Primary|Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels|Event Related Potentials (time-locked amplitudes in the electroencephalogram 100 milliseconds after the acoustic stimulus, averaged over 40 stimuli) Sedation levels were graded with the Ramsay scale (RS), where the responses of patients to standardized increasing stimuli (voice, then prodding, the pain stimulus) are graded. The higher the number, the deeper is the sedation. RS 6 means no response at all (= anesthesia)|awake + 3 sedation levels (RS2/3/4) (20 minutes each)||||micro Volt||Standard Deviation|Mean
2783440|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive test results to bronopol|||percentage of concordant responses||95% Confidence Interval|Number
2783362|NCT00641537|Primary|Number of Participants Who Developed Herpes Zoster Infections and Malignancies|Herpes zoster infection is defined as having at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms herpes zoster, herpes zoster iridocyclitis, herpes zoster ophthalmic, herpes zoster multi-dermatomal, herpes zoster infection neurological, herpes zoster oticus. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre_specified grouping Malignant and unspecified tumors.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.|||Participants|||Number
2783363|NCT00641537|Primary|Median Time to Recovery From Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1 during the CLARITY Extension Study.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. 'N' signifies number of participants who were evaluable for this outcome measure.|||days||Full Range|Median
2783364|NCT00641537|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.|||participants|||Number
2783365|NCT00641537|Secondary|Time to Disability Progression (Confirmed After 3 Months)|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. As few participants have reached EDSS progression, fourth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|ITT population included all participants who were randomized in the study.|||months|||Number
2783366|NCT00641537|Secondary|Mean Number of Combined Unique (CU) Lesions|Mean Number of CU lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|ITT population included all participants who were randomized in the study.|||lesions||Standard Deviation|Mean
2783367|NCT00641537|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|Intention-to-treat (ITT) population included all participants who were randomized in the study.|||relapses per year||95% Confidence Interval|Number
2783368|NCT00641537|Primary|Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.|||percentage of participants|||Number
2783369|NCT00641147|Other Pre-specified|Change in Akt Phosphorylation Levels||Baseline up to 12 months|||||||
2783370|NCT00641147|Other Pre-specified|Activation of NFKB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) Pathway||Baseline to 12 months|||||||
2783371|NCT00641147|Other Pre-specified|Change in Vascular Density||Baseline up to 12 months|||||||
2783372|NCT00641147|Other Pre-specified|Number of Patients Failing Study.|Patients withdrawn from study due to increasing polyp burden and/or advancing histology.|Up to 16 months.||||Participants|||Count of Participants
2783373|NCT00641147|Other Pre-specified|Change in Mucosal Prostaglandin Levels.||Baseline to up to 12 months.|The outcome data were not collected and the outcome will never be analyzed.||||||
2783374|NCT00641147|Other Pre-specified|Change in Mucosal Leukotriene Levels.||Baseline to up to 12 months.|The outcome data were not collected and the outcome will never be analyzed.||||||
2783375|NCT00641147|Other Pre-specified|Change in Mucosal DNA Methylation Levels.||Baseline to up to 12 months|The outcome data were not collected and the outcome will never be analyzed.||||||
2783376|NCT00641147|Secondary|Change in Apoptosis Index Levels|Change in apoptosis index levels at 8 months by assessing cleaved Caspase-3 measurement|8 months|Specimens for analysis were only available on 7 curcumin and 10 placebo participants.|||apoptotic rate||Standard Deviation|Mean
2783377|NCT00641147|Secondary|Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels|Change in cellular proliferation rate was measured by assessment of Ki-67 anti-proliferative cell nuclear antibody index levels at 8 months|Baseline up to 8 months|Specimens for analysis were only available on 7 curcumin and 10 placebo participants.|||labeled cells/crypt epithelial cells||Standard Deviation|Mean
2783378|NCT00641147|Secondary|Change in Spermine Oxidase (SMOX)|Change in SMOX mean activity level at 8 months compared to baseline (time 0)|Baseline and 8months||||pmol H2O2 per min per mg protein||Standard Deviation|Mean
2809830|NCT00453206|Primary|Treatment-related Mortality Within the First 6 Months After Transplantation||6 months||||participants|||Number
2783383|NCT00641147|Secondary|Medication Compliance|Medication compliance of the participant= number of capsules taken divided by the number of capsules prescribed as determined by pill count and described as a percentage per participant. Then the compliance of each participant in the assigned group (curcumin or placebo) was averaged together to obtain the medication compliance rate of that group.|Up to 12 months||||percentage of total compliance||Full Range|Median
2783384|NCT00641147|Secondary|Number of Participants With Grade >=2 Adverse Events|"Events were graded as follows:~Grade 0= no adverse event or within normal limits; Grade 1= mild adverse event (causing no limitations of usual activity); Grade 2= moderate adverse event (causing some limitation of activity); Grade 3= severe adverse event (severe and undesirable; causing inability to carry out usual activities; Grade 4= life threatening or disabling adverse event; Grade 5= fatal adverse event."|Up to 12 months||||Participants|||Count of Participants
2783385|NCT00641147|Secondary|Number of Participants With a Decrease in Polyp Burden at 12 Months|The polyp burden as evaluated by video tape review. Polyp burden at 12 months compared to time 0 for each participant and counting participants with decrease in polyp burden at 12 months.|12 months||||Participants|||Count of Participants
2783386|NCT00641147|Secondary|Mean Polyp Size in mm|Mean size of the 5 largest polyps|Up to 12 months||||mm||95% Confidence Interval|Mean
2783387|NCT00641147|Primary|Polyp Number|Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm|Up to 12 months||||polyps||95% Confidence Interval|Mean
2783388|NCT00641108|Primary|Change in Serotonin Transporter Availability||Measured at Weeks 0 and 12|The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator’s behalf, data are not available.||||||
2783389|NCT00641056|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.|Baseline to Week 26|ITT Population.|||rate per subject-year||Standard Error|Mean
2783390|NCT00641056|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmHg||Standard Deviation|Mean
2783391|NCT00641056|Secondary|Ratio of Triglycerides at Week 26 to Baseline|Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||ratio||Standard Error|Least Squares Mean
2783392|NCT00641056|Secondary|Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26|Change in HDL (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
2783393|NCT00641056|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in Total Cholesterol (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
2783394|NCT00641056|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW (kg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Least Squares Mean
2783395|NCT00641056|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
2783396|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 6.5% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
2783397|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=7.0% at Week 26|Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 7% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
2783398|NCT00641056|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26|Baseline, Week 26|ITT Population: All randomized patients who had taken at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2783399|NCT00641043|Secondary|Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2783605|NCT00640224|Secondary|Delta Androstenedione at Baseline and 6 Months|Delta Androstenedione was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
2783400|NCT00641043|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2783401|NCT00641043|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2783402|NCT00641043|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2783403|NCT00641043|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2783404|NCT00641043|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2783405|NCT00641043|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2783406|NCT00641043|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2783407|NCT00641043|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2783408|NCT00641043|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2783409|NCT00641043|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2783410|NCT00641043|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2783411|NCT00641043|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2783412|NCT00640978|Primary|Number of Participants Surviving at 6 Months|Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.|6 months||||Participants|||Number
2783413|NCT00640926|Other Pre-specified|Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)|The number of ME patients (defined as those CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila) with a microbiologic response of eradicated, i.e. either documented eradication of the baseline pathogen(s), or presumed eradication in the setting of clinical cure with no material to culture.|Study Days 14-38|Microbiologically evaluable (ME) patients were defined as CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila.|||Participants|||Number
2783441|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance:Number of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to disperse blue|||percentage of concordant responses||95% Confidence Interval|Number
2783414|NCT00640926|Primary|Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)|Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.|Study days 14-38|Clinically evaluable patients were those that had a diagnosis of CAP, as defined in the inclusion criteria; who received an appropriate course of therapy; who did not receive any other concomitant antibiotics, and who returned for a TOC visit in the appropriate time frame.|||Participants|||Number
2783415|NCT00640835|Primary|Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity|Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.|||Participants|||Number
2783416|NCT00640835|Primary|Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.|"Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:~Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs"|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.|||Participants|||Number
2783417|NCT00640822|Secondary|Patients With Rebound During the Study||Week 8-16|||||||
2783418|NCT00640822|Secondary|Patients With Relapse During the Study and Time to Relapse||Week 8-16|||||||
2783419|NCT00640822|Secondary|Total Sign Score of the Intertriginous Areas||Week 8|||||||
2783420|NCT00640822|Secondary|Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment||Week 8|||||||
2783421|NCT00640822|Secondary|Severity Scores for Redness, Thickness and Scaliness of the Face||Week 8|||||||
2783422|NCT00640822|Secondary|Total Sign Score of the Face||Week 8|||||||
2783423|NCT00640822|Secondary|Overall Disease Severity of the Face According to the Investigator's Assessment||Week 4|||||||
2783424|NCT00640822|Primary|Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8||Week 8||||Participants|||Number
2783425|NCT00640653|Secondary|Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months||Measured at baseline and3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post intervention assessment.|||Participants|||Count of Participants
2783426|NCT00640653|Secondary|Self-reported Consistent Condom Use in the Past 3 Months|Self-report of using a condom during every sexual intercourse act in the past 3 months|Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post intervention assessment.|||Participants|||Count of Participants
2783427|NCT00640653|Secondary|Self-report of Having Multiple Sexual Partners in the Past 3 Months|Self-report of having sexual intercourse with more than one partner in the pat 3 months.|Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2783428|NCT00640653|Secondary|Self-reported Sexual Intercourse in the Past 3 Months|Self-report of having sexual intercourse in the past 3 months|Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2783429|NCT00640653|Primary|Self-report of Ever Having Sexual Intercourse|Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.|24 months post-intervention|Participants reporting never having sexual intercourse at baseline (i.e., virgins) with follow-up data on self-reported sexual intercourse during the post-intervention assessments.|||Participants|||Count of Participants
2783430|NCT00640614|Secondary|Persistent Reactions: All T.R.U.E. Test Allergens|Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)|initially occur 2-4 days after application and last through 7-21days after patch application||||participants|||Number
2783431|NCT00640614|Secondary|Late Reactions: All T.R.U.E. Test Allergens|Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).|7-10 days after patch application||||participants|||Number
2783432|NCT00640614|Secondary|Safety Evaluations: All T.R.U.E. Test Allergens|Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.|Day 2: 48 hours after application|NOTE: These secondary measurements apply to the entire subject population and were not separated by 'sensitive' or 'consecutive' subjects.|||participants|||Number
2783433|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bronopol|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783434|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Disperse Blue|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783435|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Parthenolide|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783436|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bacitracin|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application||||percentage of agreement||95% Confidence Interval|Number
2783606|NCT00640224|Secondary|DHEAS at Baseline and 6 Months|DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis.|Baseline and 6 months||||ug/dL||Standard Error|Mean
2783442|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to parthenolide|||percentage of concordant responses||95% Confidence Interval|Number
2783443|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to bacitracin|||percentage of concordant responses||95% Confidence Interval|Number
2783444|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to methyldibromo-glutaronitrile|||percentage of concordant responses||95% Confidence Interval|Number
2783445|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to hydrocortizone-17-butyrate|||percentage of concordant responses||95% Confidence Interval|Number
2783446|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to gold sodium thiosulfate|||percentage of concordant responses||95% Confidence Interval|Number
2783447|NCT00640601|Secondary|Change in Barnes Akathisia Rating Scale (BARS)|The Percentage of patients with change in BARS score was calculated. The BARS is a 4 item scale that is rating Extrapyramidal symptoms (EPS) on a 4-point scale for the first three questions and on a 6-point scale for the last question. 0=normal and a higher value represents more pronounced symptoms of EPS. BARS has a focus on the akathisia symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||percentage of subjects|||Number
2783448|NCT00640601|Secondary|Change in Safety Measure: Simpson-Angus Scale (SAS)|The Percentage of patients with change in Simpson-Angus Scale (SAS)was calculated. This is a 10 item scale that is rated on a five-point scale where 0=normal and 4=severe symptoms of Extrapyramidal symptoms (EPS) with a focus on parkinsonian symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||Percentage of subjects|||Number
2783449|NCT00640601|Secondary|Change in Social and Occupational Functioning Assessment Scale (SOFAS)|Change in SOFAS score. The SOFAS is a 100 point single item scale that rates functioning of a patient. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783450|NCT00640601|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|Change in CGI-I scale. This scale is the second part of the CGI scale that is scored at Visit 3 to week 24 to observe the patient's change from start of treatment. The scores for the CGI-I subset ranges from 1 to 7 (1=very much improved, 7=very much worse and a score of 4 indicates no change.)|Day 7 - week 24|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783451|NCT00640601|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S assesses severity of illness which is scored to rate the patient's current clinical state at start of treatment. The scores range from 1 to 7, where 1= normal, not at all ill, while a score of 7=among the most extremely ill of subjects. The change from start of treatment in the severity of illness is calculated by subtracting the score at start of treatment from the visit score. Alleviation of symptom severity will be indicated by a negative change score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783452|NCT00640601|Secondary|Change in Global Assessment Scale (GAS)|Change in GAS score. The GAS is a 100-point single item scale that rates patient's functioning on a hypothetical continuum of mental health to mental illness. The scale values range from 1 to 100 (1=most impaired, 100=healthiest).|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783453|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score|Change in negative subscale of PANSS. This subscale calculates the sum of the scores in PANSS items N1-N7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783454|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score|Change in positive subscale of PANSS. This subscale calculates the sum of the scores in PANSS items P1-P7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783455|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score|Change in PANSS total score which includes Positive, Negative and General psychopathology. The PANSS is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7, where 1=absent, 7=extreme). Maximum total score: 210, minimum total score is 30. Seven items are referring to positive symptoms (P1-7), seven items to negative symptoms (N1-7) and 16 items to general psychopathology (G1-16). The assessment prior to start of treatment is considered the baseline assessment.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783456|NCT00640601|Secondary|Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score|Numerical change in CGI-CB score. The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||units on a scale||Standard Deviation|Mean
2783457|NCT00640601|Primary|Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study|Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks (or end of study)|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)|||Percentage of Participants||95% Confidence Interval|Mean
2783458|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration|Change of drug use from baseline to last visi||||Participants|||Number
2783459|NCT00640562|Secondary|Body Mass Index (BMI) at Week 12|Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.|12 week||||Kg/m^2||Standard Deviation|Mean
2783460|NCT00640562|Secondary|Change From Screening Visit to Week 12 of Prolactin Live|Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit|12 week from screening visit to last visit||||KG||Standard Deviation|Least Squares Mean
2783461|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration|12 week from baseline to last visi||||Participants|||Number
2783462|NCT00640562|Secondary|Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section|"Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.~The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40~Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments."|12 weeks from baseline to last visit||||score on scale||Standard Deviation|Mean
2783463|NCT00640562|Secondary|Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score|These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or -1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response|12 week from baseline to last visit||||score on scale||Standard Deviation|Least Squares Mean
2783464|NCT00640562|Secondary|CGI- Global Improvement Mean Score at Week 12|"The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates normal, not at all ill, while a score of 7 indicates among the most extremely ill of patients. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits"|12week: descriptive statistic of CGI by visit and treatment||||score on a scale||Standard Deviation|Mean
2783465|NCT00640562|Secondary|- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score|"The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates normal, not at all ill, while a score of 7 indicates among the most extremely ill of patients. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits"|12 weeks from baseline to last visit||||Score on scale||Standard Deviation|Least Squares Mean
2783466|NCT00640562|Secondary|Change From Baseline to Week 12 of PANSS Score|30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.|12 weeks from baseline to last visit||||score on scale||Standard Deviation|Mean
2783467|NCT00640562|Secondary|Change From Baseline to Week 12 of HAM-D Score|21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.|12 weeks from baseline to last visit||||Score on scale||Standard Deviation|Mean
2783468|NCT00640562|Primary|Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.|"The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.~CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment.~The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression."|12 week from baseline to last visit||||Score on a scale||Standard Deviation|Least Squares Mean
2783469|NCT00640510|Secondary|Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|30 min, 60 min, 90 min and 2 hours post first IM injection|Number of patients having the measure at post-baseline. Last Observation Carried Forward.|||participants|||Number
2783470|NCT00640510|Secondary|Number of Responders at 2 Hours After First Intramuscular (IM) Injection|A responder was defined ast he patient with ≥ 40% decrease in the PANSS-EC total score at 2 hours after the first IM injection in comparison with baseline. (See outcome measure 1 for description of PANSS-EC).|2 hours post first IM injection|Number of patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.|||participants|||Number
2783471|NCT00640510|Secondary|Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|15 min, 30 min, 60 min, 90 min post first IM injection|Number of patients having the measure both at baseline and post-baseline. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2783472|NCT00640510|Primary|Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|2 hours post first intramuscular (IM) injection|Number of randomized patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2783473|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - PP|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.~Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.~Scale is from 0 best to 30 worst.~0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140. Results for one were excluded because of missing DLQI questionnaire results.|||Units on a scale||Standard Deviation|Mean
2783474|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - PP|"BSA scores are evaluated at each time point.~BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140.|||Percent of body affected||Standard Deviation|Mean
2783475|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).~PGA scores are evaluated at each time point.~The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:~0 = clear~1 = minimal~2 = mild~3 = moderate~4 = severe~5 = very severe~The scale evaluates plaque elevation, scaling and erythema."|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol. And PGA was not performed for another patient (Day 168)|||Participants|||Number
2783476|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.|||Participants|||Number
2783477|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.|||Participants|||Number
2783478|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.|||Participants|||Number
2783479|NCT00640393|Secondary|Number of Serious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of serious adverse events.~Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:~death~initial or prolonged inpatient hospitalization~a life-threatening experience (that is, immediate risk of dying)~persistent or significant disability/incapacity~congenital anomaly/birth defect"|196 days|The analysis was intention to treat (ITT).|||Serious adverse events|||Number
2783480|NCT00640393|Secondary|Number of Infectious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of infectious adverse events.~Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.~Only infectious and malignant (including any type of skin cancer) adverse events were recorded."|196 days|The analysis was intention to treat (ITT).|||Infectious adverse events|||Number
2783481|NCT00640393|Secondary|Number of Adverse Drug Reactions - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions.~Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.~Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction."|196 days|The analysis was intention to treat (ITT).|||Adverse drug reactions.|||Number
2783482|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - ITT|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.~Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.~Scale is from 0 best to 30 worst.~0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2783483|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - ITT|"BSA scores are evaluated at each time point.~BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).|||Percent of body affected||Standard Deviation|Mean
2783484|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).~PGA scores are evaluated at each time point.~The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:~0 = clear~1 = minimal~2 = mild~3 = moderate~4 = severe~5 = very severe~The scale evaluates plaque elevation, scaling and erythema."|0, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non Responder (NRI).|||Participants|||Number
2783485|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
2783486|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
2783487|NCT00640393|Secondary|Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
2783488|NCT00640393|Secondary|Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
2783489|NCT00640393|Secondary|Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).|||Participants|||Number
2783490|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).|||Participants|||Number
2783491|NCT00640393|Primary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112 and 140 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).|||Participants|||Number
2783492|NCT00640341|Primary|Uncorrected Distance High Contrast Visual Acuity|logMAR high contrast visual acuity (VA) over all visits.|Over all visits for the 1 month study period|All eligible dispensed eyes.|||LogMAR|Participants|Standard Deviation|Mean
2783493|NCT00640341|Primary|Subjective Responses to Comfort-related Symptoms/Complaints|Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.|Over all follow-up visits for 1 month study period|All eligible dispensed eyes.|||Units on a Scale|Participants|Standard Deviation|Mean
2783494|NCT00640341|Primary|Any Slit Lamp Finding > Grade 2|All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.|Over all follow-up visits for the 1 month study period|All dispensed eyes|||Eyes|Participants||Number
2783495|NCT00640328|Secondary|Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."|||hours||Geometric Coefficient of Variation|Geometric Mean
2783496|NCT00640328|Secondary|The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."|||liters||Geometric Coefficient of Variation|Geometric Mean
2783497|NCT00640328|Secondary|Clearance of Ofa Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2783498|NCT00640328|Secondary|Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for tmax.|Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||hours||Full Range|Median
2783499|NCT00640328|Secondary|The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Millgram hour per liter||Geometric Coefficient of Variation|Geometric Mean
2783500|NCT00640328|Secondary|The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).|Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||milligrams per liter||Geometric Coefficient of Variation|Geometric Mean
2783518|NCT00640328|Primary|Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)|Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.|Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||participants|||Number
2783501|NCT00640328|Secondary|Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions|The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||milligrams per liter||Standard Deviation|Mean
2783502|NCT00640328|Secondary|Total Volume of T2 Lesions at Week 24 and Week 48|The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.|Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||millimeters cubed||Standard Deviation|Mean
2783503|NCT00640328|Secondary|Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)|"The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. Total T1 enhancing Ls represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage."|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||lesions||Standard Deviation|Mean
2783504|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)|Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Units per milliliter||Standard Deviation|Mean
2783505|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)|The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Degrees Celsius||Standard Deviation|Mean
2783506|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)|The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||beats per minute||Standard Deviation|Mean
2783507|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)|Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||millimeters of mercury||Standard Deviation|Mean
2783508|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||grams per liter||Standard Deviation|Mean
2783509|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2783607|NCT00640224|Secondary|SHBG at Baseline and 6 Months|SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay.|Baseline and 6 months||||nmol/L||Standard Error|Mean
2783510|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||millimoles per liter||Standard Deviation|Mean
2783511|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Units per liter||Standard Deviation|Mean
2783512|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||grams per liter||Standard Deviation|Mean
2783513|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Millimoles/liter||Standard Deviation|Mean
2783514|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Percentage of BV occupied by RBCs||Standard Deviation|Mean
2783515|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Pico (10^12) per liter||Standard Deviation|Mean
2783516|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."|||Giga (10^9) per liter||Standard Deviation|Mean
2783517|NCT00640328|Primary|Number of Participants With Abnormal Physical Examination Findings|The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS|||participants|||Number
2783536|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/min||Standard Deviation|Mean
2783519|NCT00640328|Primary|Number of Participants With the Indicated Critical Adverse Events (CAEs)|A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS|||participants|||Number
2783520|NCT00640328|Primary|Number of Participants With Any Adverse Event|"An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. Non-serious AEs were not collected during the Individualized Follow-up Period."|First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.|||participants|||Number
2783521|NCT00640315|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
2783522|NCT00640315|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
2783523|NCT00640315|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Day 3|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
2783524|NCT00640315|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Day 3|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
2783525|NCT00640315|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Day 3|PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.|||msec||Standard Deviation|Mean
2783526|NCT00640315|Secondary|Area Under the Plasma Concentration Verse Time Curve From Zero to the Last Data Point (AUC0-tn) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2783527|NCT00640315|Secondary|Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||hour||Geometric Coefficient of Variation|Geometric Mean
2783528|NCT00640315|Secondary|Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||hour||Geometric Coefficient of Variation|Geometric Mean
2783529|NCT00640315|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||hour||Full Range|Median
2783530|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage of total perfusion||Standard Deviation|Mean
2783531|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/MIN||Standard Deviation|Mean
2783532|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hours Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||L/MIN||Standard Deviation|Mean
2783533|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783534|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783535|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage of total ventilation||Standard Deviation|Mean
2783608|NCT00640224|Secondary|Free Testosterone at Baseline and 6 Months|Free testosterone was measured by equilibrium dialysis.|Baseline and 6 months||||pg/mL||Standard Error|Mean
2783539|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity at the Time When the DLCO is Measured (Alveolar Volume, VA)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783540|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783541|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783542|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783543|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783544|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783545|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783546|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783547|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783548|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783549|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC|The percent of predicted TLC was provided by investigator at site.|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783550|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783551|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783552|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783553|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783554|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783555|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783556|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783557|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783558|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783559|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783560|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)|||Percentage||Standard Deviation|Mean
2783561|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index|Cardiac index was calculated as cardiac index = CO / body surface area.|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||L/min/m^2||Standard Deviation|Mean
2783562|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)|SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
2783563|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)|SVR was calculated as SVR = 80*(MAP-RAPmean)/CO|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||dyn*s*cm^-5||Standard Deviation|Mean
2783564|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)|PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
2783565|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)|CO was measured in triplicate by the thermodilution technique|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||L/min||Standard Deviation|Mean
2783566|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)|MAP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
2783567|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)|Diastolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
2783568|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)|Systolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
2783569|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)|HR was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||beats per minute||Standard Deviation|Mean
2783570|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)|PCWP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||mmHg||Standard Deviation|Mean
2783571|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)|PAPdiast was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
2783572|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)|PAPsyst was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||mmHg||Standard Deviation|Mean
2783573|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)|RAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||mmHg||Standard Deviation|Mean
2783574|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||kg/L||Geometric Coefficient of Variation|Geometric Mean
2783575|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||10^3/L||Geometric Coefficient of Variation|Geometric Mean
2783576|NCT00640315|Primary|Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2783577|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||kg*h/L||Geometric Coefficient of Variation|Geometric Mean
2783578|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||10^3*h/L||Geometric Coefficient of Variation|Geometric Mean
2783579|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2783580|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)|PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)|||(dyn*s*cm^-5)||Standard Deviation|Mean
2783581|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)|PAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population|||mmHg||Standard Deviation|Mean
2783582|NCT00640289|Secondary|Surgical Efficacy Assessments With Factor XIII|Surgical efficacy is defined as: Excellent/Good = adequate hemostasis, similar to that expected for subjects without known bleeding disorders; Fair/Poor = hemostasis less than expected; None = severe bleeding, judged due to disease despite Factor XIII (FXIII) therapy. Only the subjects who underwent a surgical procedure were counted in this outcome measure.|During surgical procedure|SP|||Surgical procedures|Surgical procedures||Count of Units
2783583|NCT00640289|Primary|Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions|Response is defined as: Excellent/Good = adequate hemostasis, similar to that expected for subjects without known bleeding disorders; Fair/Poor = hemostasis less than expected; None = severe bleeding, judged due to disease despite Factor XIII (FXIII) therapy. Only the subjects who needed additional FXIII infusions (apart from the prophylactic treatment) to control a bleed and who had investigator assessment of efficacy were counted in this outcome.|Within 12 hours of FXIII infusion|Safety Population (SP): The safety population consists of all subjects who received a dose of FXIII during the study.|||Number of bleeds|Number of bleeds||Count of Units
2783584|NCT00640250|Secondary|Adverse Events|The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.|Days 0-21||||events|||Number
2783585|NCT00640250|Secondary|Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning|"Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions.~Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application"|Day 2-21|Data from one subject not included because subject did not have past positive response to either allergen.|||percentage of participants|||Number
2783586|NCT00640250|Primary|Concordance Between Investigational Allergen and Reference Allergen|Concordance between disperse blue or bronopol and the respective reference petrolatum allergen|Visit 5: 21 days after patch application|Data from one subject not included because subject did not have past positive response to either allergen.|||percentage of agreement||95% Confidence Interval|Number
2783587|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects|Visit 4: 7 days after application|Data from one subject not included because subject did not have past positive response to either allergen.|||percentage of participants||95% Confidence Interval|Number
2783588|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects|Visit 3: 3 days after application|Data from one subject not included because subject did not have a past positive response to either allergen.|||percentage of participants||95% Confidence Interval|Number
2783589|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects|Visit 4: 7 days after application||||percentage of participants||95% Confidence Interval|Number
2783590|NCT00640250|Primary|Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration|Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects|Visit 3: 3 days after application|All subjects|||percentage of participants||95% Confidence Interval|Number
2783591|NCT00640250|Primary|Diagnostic Performance: Optimal Test Allergen Concentration|Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects|Visits 3-5: 3-21 days after application|Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test.|||percentage of participants|||Number
2783592|NCT00640224|Secondary|Night Blood Pressure at Baseline and 6 Months|Night blood pressure was measured with an automated sphygmomanometer.|Baseline and 6 months||||mm Hg||Standard Error|Mean
2783593|NCT00640224|Secondary|Morning Blood Pressure at Baseline and 6 Months|Morning blood pressure was measured with an automated sphygmomanometer.|Baseline and 6 months||||mm Hg||Standard Error|Mean
2783594|NCT00640224|Secondary|Hs-CRP at Baseline and 6 Months|hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry.|Baseline and 6 months||||mg/L||Standard Error|Mean
2783595|NCT00640224|Secondary|Leptin at Baseline and 6 Months|Leptin was measured by radioimmunoassay.|Baseline and 6 months||||ng/mL||Standard Error|Mean
2783596|NCT00640224|Secondary|Adiponectin at Baseline and 6 Months|Adiponectin was measured by radioimmunoassay.|Baseline and 6 months||||ug/mL||Standard Error|Mean
2783597|NCT00640224|Secondary|Non-HDL Cholesterol at Baseline and 6 Months|Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
2783598|NCT00640224|Secondary|Triglycerides at Baseline and 6 Months|Triglycerides were measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
2783599|NCT00640224|Secondary|LDL at Baseline and 6 Months|LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
2783600|NCT00640224|Secondary|HDL at Baseline and 6 Months|HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
2783601|NCT00640224|Secondary|Cholesterol at Baseline and 6 Months|Cholesterol was measured using the standards of the Centers for Disease Control and Prevention.|Baseline and 6 months||||mg/dL||Standard Error|Mean
2783602|NCT00640224|Secondary|Delta 17-OHPreg at Baseline and 6 Months|Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
2783603|NCT00640224|Secondary|Delta 17-OHProg at Baseline and 6 Months|Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy.|Baseline and 6 months||||ng/dL||Standard Error|Mean
2783615|NCT00640146|Secondary|Time to First Rescue-Free Bowel Movement (Laxation)|A rescue-free laxation was defined as a laxation without use of any rescue medication or rescue procedures. Time to first rescue-free bowel movement following the first dose of study drug was reported.|Baseline (Day 1) up to Day 4 or 7|MITT population included all randomized participants who received at least 1 dose of study drug. One participant with bowel movement prior to dosing was excluded from placebo arm.|||hours||Standard Error|Mean
2783616|NCT00640146|Primary|Percentage of Participants With Laxation Response Within 4 Hours of the First Dose|Percentage of participants who had a laxation (that is, bowel movement) within 4 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.|4 hours|MITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2783617|NCT00640146|Primary|Percentage of Participants With Laxation Response Within 2 Hours of the First Dose|Percentage of participants who had a laxation (that is, bowel movement) within 2 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.|2 hours|MITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2783618|NCT00640133|Secondary|Hamilton Depression Rating Scale (HDRS)|The Hamilton Depression Rating Scale (HDRS) measures the severity of depressive symptoms in adults. The evaluator-administered ratings measure depressed mood, guilt, suicide, insomnia, work/activities, retardation, agitation, psychic and somatic anxiety, genital symptoms, hypochondriasis, and insight during the past week. Total scores range from 0-72 and higher scores indicate the presence of more severe depression over the past week. Note: this measure was only administered at baseline and month-3.|Total HDRS score observed means at month-3 time point.||||units on a scale||Standard Deviation|Mean
2783619|NCT00640133|Secondary|Behavioral Activation for Depression Scale (BADS)|The Behavioral Activation for Depression Scale (BADS) is a 29-item scale that measures the role of aversive controlling stimuli and escape and avoidance behavior in depression, specifically when and how participants become more activated over the course of treatment. Total scores range from 29-203 and lower scores indicate higher levels of escape and avoidance behavior from depression in the past week.|Total BADS score observed means at month-12 time point.|In total, 4 participants receiving active DBS did not complete BADS ratings at month 12; 3 participants exited the protocol before the month-12 endpoint and 1 participant had incomplete BADS data.|||units on a scale||Standard Deviation|Mean
2783620|NCT00640133|Secondary|Hamilton Anxiety Rating Scale (HARS)|Hamilton Anxiety Rating Scale (HARS) is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety); total scores range from 0-56. Higher scores indicate higher levels of anxiety over the past week.|HARS total score observed means at month-12 time point.||||units on a scale||Standard Deviation|Mean
2783621|NCT00640133|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|"The Montgomery Asberg Depression Rating Scale (MADRS) is an interviewer-administered measure assessing the ten symptoms of depression most sensitive to change. Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts are assessed and total scores range from 0-60 with higher scores representing the presence of more severe depression over the past week.~interviewer-administered measure assessing"|MADRS total score observed means at month-12 time point.|In total, 4 participants receiving active DBS did not complete MADRS ratings at month 12; 3 participants exited the protocol before the month-12 endpoint and 1 participant had incomplete MADRS data.|||units on a scale||Standard Deviation|Mean
2783622|NCT00640133|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-administered measure to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. We used the 16-item short form with total scores ranging from 16-80. Higher scores indicate greater satisfaction experienced during the past week.|QLESQ total score observed means at month-12 time point.|In total, 4 participants receiving active DBS did not complete Q-LES-Q ratings at month 12; 3 participants exited the protocol before the month-12 endpoint and 1 participant had incomplete Q-LES-Q data.|||units on a scale||Standard Deviation|Mean
2783623|NCT00640133|Primary|Social and Occupational Functioning Assessment Scale (SOFAS)|A numeric scale (0 through 100) used to rate the social, occupational, and psychological functioning during the week of poorest functioning in the past month. Higher scores indicate higher levels of social and occupational functioning, while low scores represent social and occupational impairment.|SOFAS score observed means at month-12 time point.||||units on a scale||Standard Deviation|Mean
2783624|NCT00640133|Primary|Global Assessment of Functioning Scale (GAF)|A numeric scale (0 through 100) used to rate the social, occupational, and psychological overall functioning during the week of poorest functioning in the past month. Higher scores indicate a higher level of functioning, while low scores indicate impaired global functioning.|GAF score observed means at month-12||||units on a scale||Standard Deviation|Mean
2783625|NCT00640133|Primary|Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings)|The Yale-Brown Obsessive-Compulsive Scale (YBOCS) is a 10 question evaluator-administered measure assessing the severity of obsessions and compulsions over the past week. Obsession and compulsion severity are evaluated separately (ratings from 0-20 for each category) with total scores ranging from 0-40. Higher scores for obsessions, compulsions and total score indicate more severe symptoms over the past week.|YBOCS total score observed means at month-12||||units on a scale||Standard Deviation|Mean
2783626|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|6 months post study|Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.|||investigators|||Number
2798177|NCT00535301|Secondary|Operative Time|Calculated as time from first incision to time of closure of last incision.|perioperative||||minutes||Inter-Quartile Range|Median
2783627|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|3 months post study|Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.|||investigators|||Number
2783628|NCT00640042|Secondary|Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.|After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.|Up to 4 months|Number of subjects with risk level assessment at Visit 4 (Week 10)|||cases|||Number
2783629|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)|Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 4 (Week 10)|Number of subjects with risk level assessment at Visit 4 (Week 10)|||participants|||Number
2783630|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)|Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 3 (Week 6)|Number of subjects with risk level assessment at Visit 3 (Week 6)|||participants|||Number
2783631|NCT00640042|Primary|Number of Subjects With Treatment Emergent Adverse Events|Adverse events that occur or worsen after the first dose of Avinza|Up to 4 months||||participants|||Number
2783632|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study|Baseline (Week 0) to Visit 5 (Week 14 / End of Study)|Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)|||units on scale||Standard Deviation|Mean
2783633|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4|Baseline (Week 0) to Visit 4 (Week 10)|Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)|||units on scale||Standard Deviation|Mean
2783634|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3|Baseline (Week 0) to Visit 3 (Week 6)|Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)|||units on scale||Standard Deviation|Mean
2783635|NCT00640016|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 84|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2783636|NCT00640016|Secondary|Accumulation Ratio for CAT-354 (RA)|Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.|Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2783637|NCT00640016|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram*day/milliliter (mcg*day/mL)||Standard Deviation|Mean
2783638|NCT00640016|Secondary|Minimum Observed Serum Concentration (Cmin) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg/mL||Standard Deviation|Mean
2785763|NCT00623623|Secondary|Number of Patients With Total Disabling Stroke|This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2783639|NCT00640016|Secondary|Maximum Observed Serum Concentration (Cmax) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
2783640|NCT00640016|Secondary|Adult Asthma Quality of Life (QoL) Questionnaire Final Score|The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 0, 28, 84 or early termination (any time before Day 84)|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
2783641|NCT00640016|Secondary|Morning Peak Flow and Peak Flow Variability|Peak flow is a participant's maximum speed of expiration.|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
2783642|NCT00640016|Secondary|Number of Participants With Exacerbations|Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
2783643|NCT00640016|Secondary|Number of Participants With Diary Data|Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.|Day 0, 4, 14, 28, 35, 56, 63 to Day and 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
2783644|NCT00640016|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Day 0 to 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.||||||
2783645|NCT00640016|Secondary|Asthma Control Questionnaire (ACQ) Total Score|The ACQ is questionnaire that comprises of 7-questions evaluating participant's asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 28, 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
2783646|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)|Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||percentage of FVC||Standard Deviation|Mean
2783647|NCT00640016|Secondary|Forced Vital Capacity (FVC)|The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters||Standard Deviation|Mean
2783648|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters||Standard Deviation|Mean
2783649|NCT00640016|Secondary|Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||log2 mg/dL||Standard Deviation|Mean
2783650|NCT00640016|Primary|Change From Baseline in Doubling Concentration of Methacholine at Day 28|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline and Day 28|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||log2 milligram/deciliter (mg/dL)||Standard Deviation|Mean
2783651|NCT00639860|Primary|New Bone Formation|Percentage of new bone formation of the alveolar bone core biopsies.|From Baseline to 12 weeks||||percentage of vital bone||Full Range|Mean
2783652|NCT00639860|Primary|Radiographic Bone Changes|Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).|From Baseline to 12 weeks||||percentage of bone fill||Full Range|Mean
2783653|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Stent to Apex)|Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks||||mm||Full Range|Mean
2783654|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Mesiodistal)|Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks||||mm||Full Range|Mean
2783655|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Buccopalatal)|Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks||||mm||Full Range|Mean
2783656|NCT00639769|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death|6 weeks after last chemotherapy||||participants|||Number
2783657|NCT00639769|Primary|Patient Response|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|6 weeks after last chemotherapy treatment|Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)|||participants|||Number
2783658|NCT00639717|Secondary|Regulatory T Cell Numbers Post-transplant||180 days|T cell numbers were not analyzed||||||
2783659|NCT00639717|Secondary|Measured Level of Circulating Plasma Markers After Transplant||100 days|Plasma markers were not analyzed.||||||
2783660|NCT00639717|Secondary|The Percentage of Patients That Experienced Graft Versus Host Disease|Incidence of acute GVHD grades 2-4 and chronic GVHD in this study population|6 Months||||percentage of patients||95% Confidence Interval|Number
2783661|NCT00639717|Primary|Percentage of Patients Who Experienced Relapse by 6 Months|Relapse rate at 6 months. Relapse is defined as recurrence of disease.|6 months||||Percentage of patients||95% Confidence Interval|Number
2783662|NCT00639717|Primary|Percentage of Patients Alive at 6 Months|Overall survival at 6 months|6 months||||percentage of patients||95% Confidence Interval|Number
2783663|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following Two IV Infusion Doses|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. For the participants that received two doses, blood samples for serum raxibacumab concentration measurement were collected from participants prior to administration of the raxibacumab and diphenhydramine doses on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose.|Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.|||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2783664|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. Blood samples for serum raxibacumab concentration measurement were collected from participants who received a single-dose prior to administration of the raxibacumab and diphenhydramine doses on Day 0, at 30 minutes and 2 to 6 hours after completion of the raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose.|Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.|||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2783665|NCT00639678|Primary|Number of Participants Who Developed an Anti-raxibacumab Antibody Response|Number of participants who developed an anti-raxibacumab antibody response during the study were assessed. .Immunogenicity testing was performed to determine if raxibacumab induced an anti-raxibacumab immune response. Testing comprised of 2 assays (screening and confirmatory). The screening assay (direct binding) was an electrochemiluminescence (ECL)-based bridging assay. A rabbit polyclonal antibody was used as a positive control. Samples above the assay cut point were considered positive. Samples identified as positive in the screening assay were confirmed positive in a confirmatory assay. Samples must have demonstrated a significant percent drop in the confirmatory inhibition of binding assay to be considered positive. The inhibition of binding confirmatory assay was performed identically to the direct binding screening assay with the exception that the samples were tested in parallel with excess unlabeled raxibacumab.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783666|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783667|NCT00639678|Primary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783668|NCT00639678|Primary|Number of Participants With Thyroid Toxicities of the Indicated Grade|Clinical thyroid parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783669|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities were assessed. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783670|NCT00639678|Primary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2798908|NCT00530842|Secondary|Static Lung Volumes|Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2783671|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities were assessed. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783672|NCT00639678|Primary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783673|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities were assessed. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783674|NCT00639678|Primary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783675|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities were assessed. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783676|NCT00639678|Primary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population|||Participants|||Number
2783699|NCT00639418|Secondary|Compliance With the Recommended Two-dose Regimen in Vaccinated Participants|Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.|Seasonal: 2007-2011||||percentage of participants|||Number
2783700|NCT00639418|Primary|Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices|Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice's care in that specific age group.|Seasonal: 2007-2011||||percentage of participants|||Number
2783701|NCT00639379|Primary|Overall Corneal Staining|Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 2 weeks use|Subjects that completed the study were analyzed.|||Units on a scale||Standard Error|Least Squares Mean
2783677|NCT00639678|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population: all participants who received at least one dose of study agent, with the assignment to treatment based on the actual treatment received, unless otherwise specified|||Participants|||Number
2783678|NCT00639626|Secondary|Lean Body Mass||6 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
2783679|NCT00639626|Primary|Blood Sugar||6 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
2783680|NCT00639509|Secondary|Median Overall Survival|Median Overall Survival|Post-Treatment||||months||95% Confidence Interval|Median
2783681|NCT00639509|Primary|Best Overall Response Rate (ORR)|Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon's optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.|From the start of the treatment until disease progression/recurrence||||participants|||Number
2783682|NCT00639509|Primary|PFS Rate|PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon's optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.|At 4 months||||percentage of participants||95% Confidence Interval|Number
2783683|NCT00639457|Secondary|Myocardial Contractility-DBP|Diastolic blood pressure; vascular pressure during ventricular relaxation (diastole)|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||mmHg||Standard Error|Mean
2783684|NCT00639457|Secondary|Myocardial Contractility-SBP|Systolic blood pressure; peak vascular pressure during ventricular contraction|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||mmHg||Standard Error|Mean
2783685|NCT00639457|Secondary|Myocardial Contractility-DT|Deceleration time; time from the peak of early diastolic filling to baseline|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||msec||Standard Error|Mean
2783686|NCT00639457|Secondary|Myocardial Contractility-LV Ejection Time|Time required to empty the left ventricle into the aorta|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||msec||Standard Error|Mean
2783687|NCT00639457|Secondary|Myocardial Contractility|E/A ratio; ratio of the early (E) to late (A) ventricular filling velocities|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.|||ratio||Standard Error|Mean
2783688|NCT00639457|Secondary|Serum Adiponectin Levels||Baseline and week 16||||µg/mL||Standard Error|Mean
2783689|NCT00639457|Secondary|Hematocrit|Percentage of blood volume that is red cells|Baseline and Week 16||||% red cells||Standard Error|Mean
2783690|NCT00639457|Secondary|Hemoglobin||Baseline and Week 16||||g/L||Standard Error|Mean
2783691|NCT00639457|Secondary|Liver Enzyme Levels||Baseline and week 16||||U/L||Standard Error|Mean
2783692|NCT00639457|Secondary|Serum Lipid and Lipoprotein Levels||Baseline and week 16||||mM/L||Standard Error|Mean
2783693|NCT00639457|Secondary|Hepatic Glucose Production Rate|ability of insulin to suppress hepatic glucose production = hepatic insulin sensitivity|Baseline and week 16||||percent suppression||Standard Error|Mean
2783694|NCT00639457|Secondary|Hepatic Lipid Content||Baseline and week 16||||percent of water||Standard Error|Mean
2783695|NCT00639457|Secondary|Abdominal Subcutaneous Fat Volume||Baseline and week 16||||cm3||Standard Error|Mean
2783696|NCT00639457|Secondary|Visceral Fat Volume||Baseline and week 16||||cm3||Standard Error|Mean
2783697|NCT00639457|Primary|Insulin-stimulated Glucose Disposal Rate|Insulin-mediated glucose disposal rate per kg of fat free mass per min|Baseline and week16||||µmol glucose/kg FFM/min||Standard Error|Mean
2783698|NCT00639418|Secondary|Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage|Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.|Seasonal: 2007-2011||||Sites|||Number
2783752|NCT00638924|Secondary|Heart Rate|Heart rate at baseline|baseline|20 to 30 years old, healthy and sedentary|||bpm||Standard Deviation|Mean
2783702|NCT00639379|Primary|Subjective Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.|1 and 2 weeks|Subjects that completed the study were analyzed.|||Units on a scale||Standard Error|Least Squares Mean
2783703|NCT00639379|Primary|Subjective Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.|1 and 2 weeks|Subjects that completed the study were analyzed.|||Units on a scale||Standard Error|Least Squares Mean
2783704|NCT00639379|Primary|Lens Stability|Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.|10-15 minutes after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.|||Eyes|||Number
2783705|NCT00639379|Primary|Lens Orientation Within 5 Degrees|Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.|1 minute after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.|||Eyes|||Number
2783706|NCT00639223|Secondary|Change in LDL-Cholesterol Measured at the Beginning and End of the Study||12 weeks||||Percentage Change||Standard Deviation|Mean
2783707|NCT00639223|Primary|Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500||12 weeks||||Participants|||Number
2783708|NCT00639158|Secondary|Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, last observation carried forward.|||Percent change||Inter-Quartile Range|Median
2783709|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit|[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoB value and at least 1 postbaseline apoB value, last observation carried forward.|||Percent change||Standard Error|Mean
2783710|NCT00639158|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, last observation carried forward.|||Percent change||Standard Error|Mean
2783711|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit|[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.|||Percent change||Standard Error|Mean
2783712|NCT00639158|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 weeks (final visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, last observation carried forward.|||Percent change||Standard Error|Mean
2783713|NCT00639158|Primary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.|||Percent change||Standard Error|Mean
2783714|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit|[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.|||Percent change||Standard Error|Mean
2783715|NCT00639158|Primary|Median Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.|||Percent change||Inter-Quartile Range|Median
2783716|NCT00639093|Secondary|Tiffany's Urge to Smoke Questionnaire||Weeks 1, 4, 6, 12, 24 and 12-month follow-up|||||||
2783717|NCT00639093|Primary|Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.|"Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.~Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up)."|Weeks 1, 4, 6, 12, 24 and 12-month follow-up||||participants|||Number
2783718|NCT00639002|Secondary|Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma|"Progressive Disease requires 1 or more of the following:~Increase of ≥ 25% from baseline in:~Serum M-component and/or (increase ≥ 0.5 g/dL).~Urine M-component and/or (increase ≥ 200 mg/24 h).~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be > l0 mg/dL.~Bone marrow plasma cell percentage ≥ 10%.~Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia."|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population. This outcome measure was not analyzed as no patients achieved a response.||||||
2783719|NCT00639002|Primary|Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma|A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h).|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population: All patients who were enrolled and took at least 1 dose of study medication.|||participants|||Number
2783720|NCT00638989|Secondary|Volume of Distribution at Steady State (Vss) After Intravenous Infusion|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM[Infinity] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).|Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mL||Standard Deviation|Mean
2783721|NCT00638989|Secondary|Apparent Systemic Clearance (CL/F) After Intravenous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mL/day||Standard Deviation|Mean
2783722|NCT00638989|Secondary|Apparent Systemic Clearance (CL/F) After Subcutaneous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).|Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mL/day||Standard Deviation|Mean
2783723|NCT00638989|Secondary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||days||Standard Deviation|Mean
2783724|NCT00638989|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||days||Full Range|Median
2783725|NCT00638989|Secondary|Dose Normalized Maximum Observed Concentration (Cmax/Dose)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||(mcg/mL)/mg||Standard Deviation|Mean
2783726|NCT00638989|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
2783727|NCT00638989|Secondary|Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC [0 - infinity]) was normalized by CAT-354 dose.|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||([mcg*day]/mL)/mg||Standard Deviation|Mean
2783728|NCT00638989|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])||Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||mcg*day/mL||Standard Deviation|Mean
2783729|NCT00638989|Secondary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.|||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
2783730|NCT00638989|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit||Day 0 and Day 56|Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.|||participants|||Number
2783731|NCT00638989|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 56|Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.|||participants|||Number
2783753|NCT00638885|Primary|Neuropsychological Testing of Memory|Percent retention on the Wechsler Memory Scale - Logical|2 days||||percentage of WMS retention||Standard Deviation|Mean
2818914|NCT00391599|Primary|Number of Participants With Bowel Sounds|bowel sounds: present|On postoperative day 1||||participants|||Number
2783732|NCT00638989|Primary|Absolute Bioavailability of CAT-354 After Subcutaneous Dose|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC [0 - infinity]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56|Pharmacokinetic (PK) population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate maximum observed serum concentration (Cmax).|||percent bioavailability||90% Confidence Interval|Geometric Mean
2783733|NCT00638963|Secondary|Number of Participants Who Completed the Third Cycle of Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Participants|||Number
2783734|NCT00638963|Secondary|Number of Participants Who Had at Least One Treatment Omission During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Participants|||Number
2783735|NCT00638963|Secondary|Number of Participants Who Had at Least One Dose Reduction During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Participants|||Number
2783736|NCT00638963|Secondary|Total Dose of Temozolomide Taken|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Milligrams||Standard Deviation|Mean
2783737|NCT00638963|Secondary|Number of Days on Temozolomide Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks||||Days||Standard Deviation|Mean
2783738|NCT00638963|Secondary|Number of Days With Brain Recurrence-free Survival (BRFS)|"BRFS was defined as the time interval from randomization to the appearance of brain metastases.~The analysis could not be performed due to low enrollment."|24,38, and 52 weeks|||||||
2783739|NCT00638963|Secondary|Number of Days With Distant Disease-free Survival (DDFS)|"DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks|||||||
2783740|NCT00638963|Secondary|Number of Days With Disease-free Survival (DFS)|"DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks|||||||
2783741|NCT00638963|Secondary|Number of Days With Progression-free Survival (PFS)|"PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks|||||||
2783742|NCT00638963|Primary|Percent of Participants With Recurrence of Brain Metastases|The analysis could not be performed due to low enrollment.|1 Year|||||||
2783743|NCT00638937|Secondary|Overall Survival|"One year overall survival rate~The Kaplan-Meier method will be used."|1 year||||percentage of participants|||Number
2783744|NCT00638937|Secondary|Median Overall Survival|The Kaplan-Meier method will be used.|Up to 1 year||||months||95% Confidence Interval|Median
2783745|NCT00638937|Secondary|Progression-free Survival|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause~The Kaplan-Meier method will be used."|6 months||||months||95% Confidence Interval|Median
2783746|NCT00638937|Secondary|Median Progression-free Survival|The Kaplan-Meier method will be used.|From the date of study enrollment to the time the criteria for disease progression are met, death or last contact, or the last tumor assessment before the initiation of further anticancer therapy, assessed up to 1 year||||months||95% Confidence Interval|Median
2783747|NCT00638937|Secondary|Duration of Response or Stable Disease|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From first response until the criteria for progression are met, assessed up to 1 year||||months||95% Confidence Interval|Median
2783748|NCT00638937|Secondary|Stable Disease Rate|"Stabilization of disease for atleast 4 cycles, leading to disease control~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for progression are met, assessed up to 1 year||||participants|||Number
2783749|NCT00638937|Secondary|Objective Response Rate (Complete and Partial Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for response are met||||participants|||Number
2783750|NCT00638937|Primary|Rate of Disease Control (Freedom From Disease Progression)|"Lack of disease progression, a combined rate of objective complete (disapprearance of all target lesions) and partial responses (>= 30% decrease in sum of longest diameter of target lesions) and stable disease as determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.0) for at least 4 cycles (16 weeks) of therapy.~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|112 days||||participants|||Number
2783751|NCT00638924|Primary|Shuttle Walk Test Distance|The distance achieved in the test in meters|baseline|20 to 30 years old, healthy and sedentary|||m||Standard Deviation|Mean
2783754|NCT00638846|Primary|Subjective Comfort|Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.|2 weeks of lens wear|Analysis was performed on participants who completed the study per protocol.|||units on a scale||Standard Error|Least Squares Mean
2783755|NCT00638846|Secondary|Overall Corneal Staining|National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|After 2 weeks use|Analysis was performed on participants who completed the study per protocol.|||units on a scale||Standard Error|Least Squares Mean
2783756|NCT00638846|Secondary|Subjective Lens Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.|measured at 1 and 2 weeks|Analysis was performed on participants who completed the study per protocol.|||units on a scale||Standard Error|Least Squares Mean
2783757|NCT00638846|Secondary|Time to Fit Lens|Time required for the optometrist to fit the lens.|after lens insertion|Analysis was performed on participants who completed the study per protocol.|||minutes||Standard Error|Least Squares Mean
2783758|NCT00638846|Primary|Lens Stability|Lens stability is measured as the amount of rotation induced from blink after the lens has settled.|10-15 minutes after insertion|Analysis was performed on participants who completed the study per protocol.|||proportion of eyes|Participants||Number
2783759|NCT00638846|Primary|Lens Orientation|Proportion of eyes with lens orientation within 5 degrees of optimal|1 minute after insertion|Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses.|||proportion of eyes|Participants||Number
2783760|NCT00638820|Secondary|Differential Imaging and Biologic Evaluations|These outcome measures were not assessed due to early study termination.|Day 100, 6 months, 1, 2 and 5 years|||||||
2783761|NCT00638820|Secondary|Number of Patients With Transplant Related Toxicity|Number of patients experiencing adverse effects due to transplant categorized by body system using Common Terminology Criteria for Adverse Events coding from the National Cancer Institute, Version 3.0.|Day 100||||Participants|||Number
2783762|NCT00638820|Secondary|Number of Patients With Transplant Related Death|Number of participants died during study by Day 100 and reason for death was related to transplant.|Day 100||||Participants|||Number
2783763|NCT00638820|Primary|Number of Patients Achieving Donor Cell Engraftment|Number of patients with persistent presence of donor-derived cells at Day 100|Day 100||||Participants|||Number
2783764|NCT00638716|Secondary|Reduction in Fasting Body Weight From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population|||kg||Standard Deviation|Mean
2783765|NCT00638716|Secondary|Reduction in FPG From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population|||mg/dL||Standard Deviation|Mean
2783766|NCT00638716|Primary|Reduction of HbA1c From Baseline|Change from Baseline|Screening and Day 85|Modified Intent-to-Treat Population|||Percent (%)||Standard Deviation|Mean
2783767|NCT00638690|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.|Up to 11 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
2783768|NCT00638690|Secondary|Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%|A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Participants|||Number
2783769|NCT00638690|Secondary|Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria|The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
2783770|NCT00638690|Primary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.|Up to 60 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
2783771|NCT00638651|Primary|Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream|To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.|approximately 14 weeks||||percentage of tattoo pigment removed|Tattoo|Full Range|Mean
2783772|NCT00638508|Secondary|PATIENT SATISFACTION|"Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied."|48 hours afetr surgery||||units on a scale||Standard Deviation|Mean
2783773|NCT00638508|Secondary|PATIENT SATISFACTION|"Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
2783774|NCT00638508|Secondary|VOMITING|Data on number of episodes of vomiting was obtained, 12 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.|12 hours||||EPISODES||Standard Deviation|Mean
2783775|NCT00638508|Secondary|VOMITING|Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.|6 hours after surgery||||EPISODES||Standard Deviation|Mean
2783776|NCT00638508|Secondary|NAUSEA|"The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous."|48 hours||||units on a scale||Standard Deviation|Mean
2783777|NCT00638508|Secondary|NAUSEA|"The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
2783778|NCT00638508|Secondary|DROWSINESS|"The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy."|48 hours||||units on a scale||Standard Deviation|Mean
2783779|NCT00638508|Secondary|DROWSINESS|"The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
2783780|NCT00638508|Secondary|Morphine Equivalents|Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams.|48 hours afetr surgery||||milligrams||Standard Deviation|Mean
2783781|NCT00638508|Secondary|Morphine Equivalents|Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams.|12 hours after surgery||||milligrams||Standard Deviation|Mean
2783782|NCT00638508|Secondary|Morphine Equivalents Utilization|Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams.|1 hour after surgery||||miliigrams||Standard Deviation|Mean
2783783|NCT00638508|Primary|Pain on Movement|"Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|48 hours afetr surgery||||units on a scale||Standard Deviation|Mean
2783784|NCT00638508|Primary|Pain Scores on Movement|"Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|6 hours after surgery||||units on a scale||Standard Deviation|Mean
2783785|NCT00638508|Primary|Pain on Movement|"Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|1 hour after surgery||||units on a scale||Standard Deviation|Mean
2783786|NCT00638508|Primary|Pain Scores on Coughing|"Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|48 hours after surgery||||units on a scale||Standard Deviation|Mean
2783787|NCT00638508|Primary|Pain Scores on Coughing|"Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|6 hours after surgery||||units on a scale||Standard Deviation|Mean
2783788|NCT00638508|Primary|Pain Score on Coughing|"Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|1 hour after the surgery||||units on a scale||Standard Deviation|Mean
2783789|NCT00638508|Primary|Pain Scores at Rest|"Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|48 hours after surgery||||units on a scale||Standard Deviation|Mean
2783790|NCT00638508|Primary|Pain Score at Rest|"Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|At the end of 6 hours after surgery||||units on a scale||Standard Deviation|Mean
2783791|NCT00638508|Primary|Pain Scores at Rest|"Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity."|1 hour after the surgery||||units on a scale||Standard Deviation|Mean
2783792|NCT00638456|Secondary|Symptom Score|"Total score was based on the following symptoms:~Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding~Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms."|Baseline and 3 Months||||units on a scale||Full Range|Mean
2783793|NCT00638456|Secondary|Upper Gastrointestinal Endoscopy Score|"Endoscopy scoring tool took into account the following categories:~Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/tissue-paper mucosa Histology scoring tools Epithelial histology score Peak eosinophil count~Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease."|Baseline and 3 Months||||units on a scale||Full Range|Mean
2783794|NCT00638456|Primary|Number of Participants With Improvement of Espohageal Eosinophilia|Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.|3 Months|6 subjects withdrew from the oral viscous budesonide plus Prevacid group and 2 withdrew from the placebo plus Prevacid group, and so they were not included in the data analsyis.|||Participants|||Count of Participants
2783807|NCT00638404|Secondary|Anxiety|measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious|anticipated anxiety prior to surgery||||units on a scale||Standard Deviation|Mean
2783795|NCT00638443|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783796|NCT00638443|Secondary|Roland Morris Disability Questionnaire|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783797|NCT00638443|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven pain interference sub-scales. The final interference score is an average of the seven sub-scales (0 indicating no interference and 10 indicating complete interference).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783798|NCT00638443|Secondary|Swiss Spinal Stenosis- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783799|NCT00638443|Secondary|Swiss Spinal Stenosis (SSS) Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783800|NCT00638443|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A total score range of 0-50; score of 0 indicates no disability and a score of 50 would indicate 100% disability.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783801|NCT00638443|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2783802|NCT00638443|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity multiplied by the amount of time the subject walked.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale * minutes||Standard Error|Mean
2783803|NCT00638443|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||minutes||Standard Error|Mean
2783804|NCT00638443|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||meters||Standard Error|Mean
2783805|NCT00638443|Secondary|Final Pain as Measured by NRS|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Error|Mean
2783806|NCT00638443|Primary|Time to First Symptoms of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|The analyses included all enrolled randomized subjects according to the inclusion and exclusion criteria except for the three who withdrew from the trial prior to the completion of the study. One dropped out of the study due to an adverse event (dizziness).|||minutes||Standard Deviation|Mean
2783808|NCT00638404|Secondary|Anticipated Postoperative Pain at Preoperative Evaluation|anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable|anticipated postoperative pain||||units on a scale||Standard Deviation|Mean
2783809|NCT00638404|Secondary|Anticipated Pain Medication Requirement|measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required|24 hours||||units on a scale||Full Range|Median
2783810|NCT00638404|Primary|Evoked Pain at 24 Hours VAS|Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain|evoked pain at 24 hours|evoked pain outcome-measured on a scale of 0=no pain up to 100=most severe pain imaginable.|||units on a scale||Standard Deviation|Mean
2783811|NCT00638378|Secondary|Number of Participants With a Complete Response or Partial Response|Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.|From Baseline through the end of study (up to 8 months)|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of tumor response rate was not assessed.||||||
2783812|NCT00638378|Primary|Number of Participants With Adverse Events (AE)|A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|From Baseline through to the end of study (up to 8 months)|The Safety population included all enrolled patients who received at least 1 dose of study medication.|||Participants|||Number
2783813|NCT00638378|Secondary|Time to Progression|"The time from first dosing day to the date of disease progression:~Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results).~Development of unequivocal new lesions on bone scan without clinical suspicion of a flare reaction.~In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value.~In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value."|From Baseline until the end of study (up to 8 months).|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of median time to progression was not assessed.||||||
2783814|NCT00638378|Primary|Number of Participants With a Prostate-specific Antigen Response|A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.|Assessed monthly from Baseline until the end of study (up to 8 months)|The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.|||participants|||Number
2783815|NCT00638365|Primary|The Safety and Tolerability of a Single-dose of KB001.|Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.|Day 28|Safety population: all subjects randomized and receiving any study medication.|||Number of participants experiencing AEs|||Number
2783816|NCT00638274|Secondary|Number of Participants With Failed Epidural Catheters|Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.|24 hours||||Participants|||Count of Participants
2783817|NCT00638274|Primary|Success of Spinal Labor Analgesia From Combined Spinal Epidural|Number of participants that had successful spinal labor analgesia in each group.|24 hours||||Participants|||Count of Participants
2783818|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline|||Percentage of participants||95% Confidence Interval|Number
2783819|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline|||percentage of participants||95% Confidence Interval|Number
2783882|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8|This analysis was conducted using only data for patients that completed the baseline through week 8 time points.|||participants|||Number
2798909|NCT00530842|Secondary|Static Lung Volumes|Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2783820|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with uterine descent >=stage II at baseline|||Percentage of participants||95% Confidence Interval|Number
2783821|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with uterine descent >=stage II at baseline|||Percentage of participants||95% Confidence Interval|Number
2783822|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline|||percentage of participants||95% Confidence Interval|Number
2783823|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline|||percentage of participants||95% Confidence Interval|Number
2783824|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline|||percentage of participant||95% Confidence Interval|Number
2783825|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with uterine descent >=stage II at baseline|||percentage of participant||95% Confidence Interval|Number
2783826|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783827|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783828|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783829|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783830|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783831|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783832|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783833|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783834|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M|Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||scores on a scale||Standard Deviation|Mean
2783835|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783836|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783837|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783838|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2787859|NCT00609336|Secondary|Surgical Completion Rate and Complication Rate||Up to 6 weeks following the completion of chemoradiotherapy|all eligible patients|||Participants|||Count of Participants
2783839|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783840|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 3 Months Post Procedure|Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure|baseline and 3 months|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||Percentage of participants||Standard Deviation|Mean
2783841|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)|||Percentage of participants|||Number
2783842|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)|||Percentage of participants|||Number
2783843|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)|||Percentage of participants|||Number
2783844|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)|||Percentage of participants|||Number
2783845|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)|||Percentage of participants|||Number
2783846|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)|||Percentage of participants|||Number
2783847|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)|||Percentage of participants|||Number
2783848|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|12 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)|||Percentage of participants|||Number
2783849|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months|"The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.|||Percentage of participants||95% Confidence Interval|Number
2783870|NCT00638183|Secondary|Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks|Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation|Pre treatment and 52 weeks after the treatment|All patients for which respiratory function testing was conducted at baseline and at 52 weeks|||Liters||Standard Deviation|Mean
2787980|NCT00608491|Secondary|Glomerular Filtration Rate Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
2783850|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months|The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.|||Percentage of participants||95% Confidence Interval|Number
2783851|NCT00638235|Secondary|Surgical Revision Rate|The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.|Through 24 months|Percentage of total subjects experienced surgical revision (%)|||Percentage of participants|||Number
2783852|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 Months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)|||Percentage of participants|||Number
2783853|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure|"Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure"|baseline and 6 weeks|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|||scores on a scale||Standard Deviation|Mean
2783854|NCT00638235|Secondary|Rates of de Novo or Worsening Urinary and/or Anal Incontinence|Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence|Through 24 months|Rate of subjects experiencing different type of incontinenece (%)|||Percentage of participants|||Number
2783855|NCT00638235|Secondary|Rate of Graft Extrusions|Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall|Through 24 months|Rate of subjects experiencing graft exposure through the vagina (%)|||Percentage of participants|||Number
2783856|NCT00638235|Secondary|Percent of Subjects Experiencing Major Device Related Complications|This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure|Through 24 months|Total subjects experienced major complications(%)|||Percentage of participants|||Number
2783857|NCT00638235|Secondary|Estimated Blood Loss|Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml|Approximately 30 minutes||||milliliters||Standard Deviation|Mean
2783858|NCT00638235|Secondary|Procedural Time|Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes|Approximately 30 minutes||||minutes||Standard Deviation|Mean
2783859|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|"Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline.~Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included."|6 Months|Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.|||scores on a scale||Standard Deviation|Mean
2783860|NCT00638235|Primary|Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|"Analysis conducted only for those subjects with posterior vaginal wall prolapse >= stage II at baseline. Where a zero is indicated, no subjects meeting this criteria were enrolled."|||percentage of participant||95% Confidence Interval|Number
2783861|NCT00638222|Secondary|Plasma F2-isoprostanes||week 1, 8, 11, 18|||||||
2783862|NCT00638222|Secondary|Plasma NT-pro BNP||week 1, 8, 11, 18|||||||
2783863|NCT00638222|Secondary|Plasma Cardiac Troponin T||week 1, 8, 11, 18|||||||
2783864|NCT00638222|Secondary|Plasma C-reactive Protein||week 1, 8, 11, 18|||||||
2783865|NCT00638222|Secondary|Interleukin-6||week 1, 8, 11, 18|||||||
2783866|NCT00638222|Secondary|Oxidized LDL||week 1, 8, 11, 18|||||||
2783867|NCT00638222|Primary|Micro T- Wave Alternans||week 1, 8, 11, 18|||||||
2783868|NCT00638183|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data|||Participants|||Number
2783869|NCT00638183|Primary|Number of Patients With Adverse Events (AEs)|Number of patients with AEs|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data|||Participants|||Number
2787981|NCT00608491|Secondary|Creatinine Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2783871|NCT00638183|Secondary|Effective Rate of Comprehensive Evaluation|"Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.~Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided comprehensive evaluation.~comprehensive evaluation was classified into 3 category, improve No change+Aggravated and Unassessable by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of Improvement in total number of analyzed patients"|52 weeks|249 patient were evaluated the efficacy|||percentage of effective patients|||Number
2783872|NCT00638157|Secondary|Summary of the Investigator's Assessment of Clinical Response at the TOC Visit|TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.|TOC Visit|Modified Intent-to-Treat (mITT) population includes all ITT patients who received at least one dose of study medication.|||Participants|||Number
2783873|NCT00638157|Primary|Summary of Clinically Significant Increases in Serum Creatinine by Visit|The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.|Baseline, EOT Visit, TOC|Safety Population includes all patients who received any dose of study medication.|||Participants|||Number
2783874|NCT00638027|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12|"9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely.~Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.~The MSFC is based on the concept that scores for these 3 dimensions—arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome."|Baseline, Week 12|Per protocol|||Z score||Standard Deviation|Mean
2783875|NCT00638027|Secondary|Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks|"Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis.~Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome."|baseline, 12 weeks|per protocol|||units on a scale||Standard Deviation|Mean
2783876|NCT00638027|Primary|Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks|"spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities.~Score: Degree of Muscle Tone 0: no increase in tone~slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.~more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved.~considerable increase in muscle tone, passive movement difficult.~affected part(s) rigid in flexion or extension."|Baseline and 12 weeks|Per Protocol|||units on a scale||Standard Deviation|Mean
2783877|NCT00638014|Secondary|Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union|The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.|Up to 180 days||||Participants|||Number
2783878|NCT00638014|Primary|Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved|Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).|Baseline, Maximum value during postoperatively days 1 thru 7||||percentage change||Standard Deviation|Mean
2783879|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up|This analysis was conducted using only data for patients that completed the baseline through the end of follow-up time points.|||participants|||Number
2783880|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment|This analysis was conducted using only data for patients that completed the baseline through end of treatment time points.|||participants|||Number
2783881|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up|From baseline to week 16|This analysis was conducted using only data for patients that completed the baseline through week 16 time points.|||participants|||Number
2785764|NCT00623623|Secondary|Number of Patients With Total Fatal Stroke|This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2783883|NCT00637923|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment||||participants|||Number
2783884|NCT00637923|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment||||participants|||Number
2783885|NCT00637923|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment||||participants|||Number
2783886|NCT00637923|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment||||participants|||Number
2783887|NCT00637806|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study||||||
2783888|NCT00637806|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study||||||
2783889|NCT00637806|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study||||||
2783890|NCT00637806|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study||||||
2783891|NCT00637780|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (<) 40 or more than (>) 120 beats per minute (bpm); erect pulse rate <40 or >140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >=20 mm Hg; SBP <90 mm Hg; and DBP <50 mm Hg.|Screening, Day 0, and Day 7|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||participants|||Number
2783892|NCT00637780|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).|Screening, Day 0, and Day 7|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||participants|||Number
2783893|NCT00637780|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Screening through to and including 28 calendar days after the last administration of the investigational product|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||participants|||Number
2783894|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) AUCtau at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg*hr/mL|||Number
2783895|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) Tmax at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||hr|||Number
2783896|NCT00637780|Primary|5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg/mL|||Number
2783897|NCT00637780|Primary|Sulfapyridine AUCtau at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg*hr/mL|||Number
2783898|NCT00637780|Primary|Sulfapyridine Tmax at Steady State|Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||hr|||Number
2783899|NCT00637780|Primary|Sulfapyridine Steady State Cmax and Cmin|Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.|Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg/mL|||Number
2783900|NCT00637780|Primary|Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||mcg*hr/mL|||Number
2802449|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|1 Month|Data available at 1 month follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2783901|NCT00637780|Primary|Sulfasalazine Time for Cmax (Tmax) at Steady State||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||hours (hr)|||Number
2783902|NCT00637780|Primary|Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)||Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose|The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.|||micrograms (mcg)/milliliter (mL)|||Number
2783903|NCT00637728|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
2783904|NCT00637728|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
2783905|NCT00637728|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
2783906|NCT00637728|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.||||||
2783907|NCT00637572|Secondary|Appetite at Baseline (Day 3) and Week 12|"Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was To what extent has your appetite changed since the start of treatment? The response was captured on a VAS scale in cm with a range from 0 ( much worse) to 10 (much better)."|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.|||cm||Standard Deviation|Mean
2783908|NCT00637572|Secondary|Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)|The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.|||cm||Standard Deviation|Mean
2783909|NCT00637572|Secondary|Change in Total Energy|Food intake was quantified by the 24-hour recall food diary|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.|||kcal||Standard Deviation|Mean
2783910|NCT00637572|Secondary|Change in Mid-arm Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit|||cm||Standard Deviation|Mean
2783911|NCT00637572|Secondary|Change in Tricep Skinfold||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit|||cm||Standard Deviation|Mean
2783912|NCT00637572|Secondary|Change in Waist Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available data measurements.|||cm||Standard Deviation|Mean
2783913|NCT00637572|Secondary|Change in Hip Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.|||cm||Standard Deviation|Mean
2783914|NCT00637572|Secondary|Change From Baseline in Body Fat Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.|||kg||Standard Deviation|Mean
2783915|NCT00637572|Secondary|Change From Baseline in Impedance|Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.|||ohms||Standard Deviation|Mean
2784095|NCT00636207|Primary|t1/2 of Montelukast - Multiple Doses|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Standard Deviation|Mean
2783916|NCT00637572|Secondary|Change From Baseline in Lean Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.|||kg||Standard Deviation|Mean
2783917|NCT00637572|Primary|Change in Body Weight|Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit|||kg||Standard Deviation|Mean
2783918|NCT00637494|Secondary|Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56|Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone|56 days||||participants|||Number
2783919|NCT00637494|Primary|Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56|Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone|56 days||||participants|||Number
2783920|NCT00637416|Primary|Change in Condition Over Treatment Period|Change measured using voice assessment protocol—Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).|3 months|Study was stopped early, data were not collected, and zero participants were analyzed.||||||
2783921|NCT00637377|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF|CNV area values measured in square millimeters; lower values represent better outcomes.|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||mm^2||Standard Deviation|Mean
2783922|NCT00637377|Secondary|Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF|The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||Scores on a scale||Standard Deviation|Mean
2783923|NCT00637377|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF|"Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.~Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Full-Analysis Set; imputation technique: LOCF|||Percentage of participants|||Number
2783924|NCT00637377|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|Full-Analysis Set (FAS); imputation technique: LOCF|||Letters correctly read||Standard Deviation|Mean
2783925|NCT00637377|Primary|Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)|"Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.~Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Per-Protocol Set (PPS); imputation technique: LOCF|||Percentage of participants|||Number
2783926|NCT00637312|Primary|Evaluation of Device and/or Procedure Related Adverse Event(s)||At 24-months|The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.||||||
2783927|NCT00637299|Secondary|Lung Function Test|residual volume (RV)|4 weeks||||liters||Standard Deviation|Mean
2783928|NCT00637299|Primary|Walking Ability|6 minutes walking test (6MWT)|4 weeks||||meters||Standard Deviation|Mean
2783929|NCT00637273|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 26|ITT Population.|||rate per subject-year||Standard Error|Mean
2783930|NCT00637273|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||Standard Error|Least Squares Mean
2783931|NCT00637273|Secondary|Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26|Change in fasting HDL from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2783932|NCT00637273|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 26|Change in fasting total cholesterol from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2786388|NCT00619645|Secondary|Number of Patients Alive 24 Months Post Day 100 Transplant|Patients will be followed for survival for 24 months post day 100 transplant.|24 months post day 100 transplant||||Participants|||Count of Participants
2783933|NCT00637273|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26|Change in diastolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
2783934|NCT00637273|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
2783935|NCT00637273|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26|Change in fasting plasma glucose from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2783936|NCT00637273|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||Standard Error|Least Squares Mean
2783937|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2783938|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2783939|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <7% at Week 26|Percentages of subjects achieving HbA1c target values of <7% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2783940|NCT00637273|Primary|Change in HbA1c From Baseline to Week 26|Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].|Day 1, Week 26|The ITT Population included randomized subjects who received at least one injection of study medication. Missing data up to Week 26 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2783941|NCT00637247|Secondary|Progression Free Survival|To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|one year|Intention to treat|||months||95% Confidence Interval|Median
2783942|NCT00637247|Secondary|Objective Response Rates of the Two Treatment Arms|Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|one year|Per protocol, response evaluable population was treated and had baseline and at least one response evaluation.|||percent of responses|||Number
2783943|NCT00637247|Primary|To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events|Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events|Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months|This includes only those subjects that received at least 1 dose of study treatment. There were 67 subjects in the imexon + gemcitabine arm and 68 in the placebo + gemcitabine arm.|||participants|||Number
2783944|NCT00637247|Primary|Overall Survival for the Intent to Treat Population|To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.|up to 2 years|Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive.|||months||95% Confidence Interval|Median
2783945|NCT00637195|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783946|NCT00637195|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2787295|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population|Total Lesion Count is the sum of inflammatory and noninflammatory lesions.|Baseline to Week 12|ITT Population|||Lesions||Standard Deviation|Mean
2783947|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783948|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783949|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.~Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783950|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.~Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783951|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.~Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783952|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.~Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2783953|NCT00637195|Secondary|Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2783954|NCT00637195|Secondary|Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.|Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||Participants|||Count of Participants
2783955|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies|Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.|Months 2, 3 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||Participants|||Count of Participants
2783956|NCT00637195|Secondary|Anti-HPV-16/18 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|Months 2 and 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2783957|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination.~Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|Months 2 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.|||Participants|||Count of Participants
2783958|NCT00637195|Primary|Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix|Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2783959|NCT00637195|Primary|Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix|A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .|||Participants|||Count of Participants
2783960|NCT00637156|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
2783961|NCT00637156|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
2783962|NCT00637156|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
2783963|NCT00637156|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
2783964|NCT00637156|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation||||units on a scale||Standard Deviation|Mean
2783965|NCT00637156|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.|24 months||||percentage of participants|||Number
2783966|NCT00637156|Secondary|Hospital Stay||From admission to discharge, an average of 1.0-1.5 day||||days||Standard Deviation|Mean
2783967|NCT00637156|Secondary|Blood Loss||During the time of operation, an average of 1.7-2.1 hrs||||ml||Standard Deviation|Mean
2783968|NCT00637156|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, an average of 1.7-2.1hrs||||hrs||Standard Deviation|Mean
2783969|NCT00637156|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
2783970|NCT00637156|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.|||percentage of participants|||Number
2783971|NCT00637156|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.|||percentage of participants|||Number
2783972|NCT00637156|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.|||percentage of participants|||Number
2783973|NCT00637156|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
2784096|NCT00636207|Primary|Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Standard Deviation|Mean
2783974|NCT00637156|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
2783975|NCT00637156|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
2783976|NCT00637156|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.|||percentage of participants|||Number
2783977|NCT00637156|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;~Maintenance or improvement in neurological status;~No serious adverse event classified as implant associated or implant/surgical procedure associated; and~No additional surgical procedure classified as a failure."|24 Months|The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.|||percentage of participants|||Number
2783978|NCT00637000|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.~Severity was graded by the investigator as mild (grade 1), moderate (grade 2) and severe (grade 3)."|Day 1-6|The randomized population included all subjects who were randomized to soluble films and received at least one dose of soluble films.|||participants|||Number
2783979|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Does the Drug Make You Sick?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug make you sick?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783980|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Like the Drug?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you like the drug?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783981|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Does the Drug Have Any Bad Effects?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug have any bad effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2784019|NCT00636805|Secondary|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during days 2 through 5 of chemotherapy treatment during the first cycle of treatment|Days 2-5 of the first week of chemotherapy|Intent-to-treat; 10 patients did not complete the study measure for days 2-5 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
2783982|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Good Effects?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any good effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783983|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: Do You Feel Any Drug Effect?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any drug effect?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783984|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783985|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Make You Sick?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug make you sick?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783986|NCT00637000|Secondary|"CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Do You Like the Drug?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you like the drug?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783987|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Have Any Bad Effects?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Does the drug have any bad effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783988|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Does the Drug Have Any Good Effects?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any good effects?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783989|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: Do You Feel Any Drug Effect?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, Do you feel any drug effect?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783990|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high.~The baseline VAS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak VAS was the highest VAS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783991|NCT00637000|Secondary|Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)|Pupil diameter was measured at the end of induction (47.5 hours after the first administration of study intervention) and at intervals during the post-induction period (Days 3-5). Peak post induction measurement is the minimum pupil diameter recorded during days 3-5.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||mm||Standard Deviation|Mean
2783992|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the minimum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||mm||Standard Deviation|Mean
2783993|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the maximum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||mm||Standard Deviation|Mean
2783994|NCT00637000|Secondary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The end of induction COWS was the score obtained 47.5 hours after first administration of soluble films on Day 1. Peak post induction COWS was the highest COWS score obtained on Days 2-5."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783995|NCT00637000|Primary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.|||units on a scale||Standard Deviation|Mean
2783996|NCT00636987|Primary|Characterize the Hemodynamic Performance of the Valve|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve."|5 Year|Number of participants that completed the visit and assessment|||mmHg||Standard Deviation|Mean
2783997|NCT00636987|Primary|Characterize Patient NYHA Functional Classification Status|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|5 year|Number of participants that completed the visit and assessment|||participants|||Number
2783998|NCT00636987|Primary|Number of Participants With Adverse Events|Number of participants with Adverse Events|5 Years||||participants|||Number
2783999|NCT00636961|Secondary|Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14|The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect.|Day 1, Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Score on a scale||90% Confidence Interval|Least Squares Mean
2784000|NCT00636961|Secondary|Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14|Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Score on a scale||90% Confidence Interval|Least Squares Mean
2784001|NCT00636961|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Liters||90% Confidence Interval|Least Squares Mean
2784002|NCT00636961|Secondary|Static Inspiratory Capacity (IC) at Day 14|Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate,|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Liters||90% Confidence Interval|Least Squares Mean
2784003|NCT00636961|Primary|Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14|Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.|||Liters||90% Confidence Interval|Least Squares Mean
2784004|NCT00636818|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 Weeks|Number of participants who received at least one dose of study drug.|||participants|||Number
2784005|NCT00636818|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval (QTcF) was used.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.|||participants|||Number
2784006|NCT00636818|Secondary|Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.|||participants|||Number
2784007|NCT00636818|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.|||participants|||Number
2784008|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)|SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score*10+50 in each subscale. Range cannot be specified in norm-based scores.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||T-Score||Standard Deviation|Mean
2784033|NCT00636649|Secondary|Change in Beck Anxiety Inventory (BAI) Score|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.|Baseline, 12 weeks||||units on a scale||Standard Error|Mean
2784009|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Stroop Color Word Test|This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||number of correct answers||Standard Deviation|Mean
2784010|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)|The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2784011|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2784012|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2784013|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2784014|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2784015|NCT00636818|Primary|Discontinuations Due to Adverse Events (AE)|The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.|Baseline to 8 Weeks|Number of participants who received at least one dose of study drug.|||participants|||Number
2784016|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from the mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue. Acute CINV complete response (CR) is defined as not having an emetic episode or any use of antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy|||units on a scale||95% Confidence Interval|Mean
2784017|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy|||units on a scale||95% Confidence Interval|Mean
2784018|NCT00636805|Secondary|Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities|Percentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|6 weeks||||participants|||Number
2784034|NCT00636649|Secondary|Change in Lipid Panel||Baseline,12 weeks||||mg/dL||Standard Error|Mean
2784035|NCT00636649|Secondary|Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2|The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.|12 weeks||||participants|||Number
2784020|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
2784021|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
2784022|NCT00636805|Primary|Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|first 24 hours of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy|||percentage of participants||95% Confidence Interval|Number
2784023|NCT00636792|Secondary|Number of Participants With Overall Response (Complete and Partial Response)|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|12 weeks after the last subject completes their end of treatment visit||||participants|||Number
2784024|NCT00636792|Primary|Number of Participants With Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|12 weeks after the last subject completes their end of treatment visit.|Response-evaluable population is defined at patients treated with 90 mg/m^2 bendamustine, received at least one dose of any study drug, and had at least one post baseline response assessment.|||participants|||Number
2784025|NCT00636701|Primary|Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .|Baseline (day 0) and 2 weeks|Four right‐handed healthy volunteers (two men, aged 20–50 years) participated in a double‐blind study of primed and unprimed rTMS.|||percentage change of BOLD||Standard Deviation|Mean
2784026|NCT00636675|Secondary|Change in Weighted Average of Staff Interaction Scales|This is a summary measure of 7 staff surveys using the weighted average on a 1-5 Likert scale with 5 indicating the highest (best) quality. Scales include Communication Openness, Accuracy, and Timeliness; Participation in Decision Making, Local Interaction Strategies, Safety Climate, and Staff Perceptions of Quality. Number presented is the change from baseline attributable to the intervention. Higher numbers represent a greater change attributable to the intervention.|baseline to post intervention, an average of 6 months||||units on a scale||Standard Error|Mean
2784027|NCT00636675|Secondary|Fall Rates|Numerator: number of falls occurring in a 6 month period, denominator: number of bed days for resident. Rate adjusted for baseline rate and casemix. Note that this measure is NOT related to staff but rather residents in the nursing home. The residents were not considered enrolled participants in the study.|6 months post intervention|Residents with at least one prior fall|||fall rate||Inter-Quartile Range|Median
2784028|NCT00636675|Primary|Fall Related Process Measures|Mean of the total number of fall risk reduction indicators (steps staff have taken to reduce fall risk) that were documented in residents with high fall risk. These included orthostatic blood pressure measurement/intervention; sensory impairment evaluation/intervention; footwear; exercise/assistive device intervention; toileting schedule; environmental modification; psychoactive medication reduction; and vitamin D supplements. Note that this measure is NOT related to staff but rather residents in the nursing home, therefore the numbers are different from participant flow. The residents were not considered enrolled participants in the study.|6 months post intervention|Residents with prior fall|||number of fall risk reduction indicators||Standard Deviation|Mean
2784029|NCT00636649|Secondary|Number of Participants Who Had a 50% Reduction in NEQ Scores|The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.|Week 12||||participants|||Number
2784030|NCT00636649|Secondary|Number of Participants Who no Longer Meet the NESHI Criteria|The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.|Week 12||||participants|||Number
2784031|NCT00636649|Secondary|Change in Weight||Baseline, 12 week||||kg||Standard Error|Mean
2784032|NCT00636649|Secondary|Change in Glucose||Baseline, 12 Week||||mg/dL||Standard Error|Mean
2784036|NCT00636649|Secondary|Change in Three Factor Eating Questionnaire (TFEQ)|"The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).~RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale"|Baseline, 12 weeks||||units on a scale||Standard Error|Mean
2784037|NCT00636649|Secondary|Change in Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|12 weeks|Participants who completed PSS assessment at baseline and week 12.|||units on a scale||Standard Error|Mean
2784038|NCT00636649|Secondary|Change in Coping Inventory for Stressful Situations (CISS)|TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.|Baseline, 12 weeks||||t-scores||Standard Error|Mean
2784039|NCT00636649|Secondary|Change in Beck Depression Inventory II (BDI-II) Score|The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.|Baseline, 12 weeks||||units on a scale||Standard Error|Mean
2784040|NCT00636649|Primary|Night Eating Questionnaire|The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.|baseline, 12 weeks|Data were analyzed as intent-to-treat with all 40 patients included in the analysis. Primary endpoint was change in the NEQ total score, i.e., difference between values between Week 12 (study exit) and baseline. Analysis of covariance was the primary statistical procedure with baseline NEQ score and baseline BMI as covariates.|||units on a scale||Standard Error|Mean
2784041|NCT00636636|Other Pre-specified|Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10).|10 weeks||||Scores on a scale||Standard Error|Least Squares Mean
2784042|NCT00636636|Secondary|Average Daily Sleep Interference Score|Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10).|10 weeks||||Scores on a scale||Standard Error|Least Squares Mean
2784043|NCT00636636|Secondary|Clinical Global Impression of Change (CGIC)|"Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks||||Participants|||Number
2784044|NCT00636636|Secondary|Patient Global Impression of Change (PGIC)|"Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks|ITT, BOCF|||Participants|||Number
2784045|NCT00636636|Primary|Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10).|10 weeks|ITT, BOCF|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2784046|NCT00636610|Secondary|Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression|Indian + Sonic Hedgehog antigen expression was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from archival tumor tissue taken from each patient prior to enrollment in the study. Results are reported in 3 categories; the 33% of patients with the lowest level of expression, the 35% of patients with a middle level of expression, and the 32% of patients with the highest level of expression. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 64 patients in the vismodegib group and 75 patients in the placebo group.|||Months||90% Confidence Interval|Median
2784097|NCT00636207|Primary|Tmax of Montelukast - Multiple Doses|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Full Range|Median
2784047|NCT00636610|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients.|||Months||90% Confidence Interval|Median
2784048|NCT00636506|Primary|Physician Evaluation of OR Device Preparation Time|Physicians were asked if the design of the pre-threaded needle facilitated faster loading of the Furlow tool. Answer options were: Yes; No|For duration of surgery|Physician assessment of each patient at time of implant|||percentage of physician responses|||Number
2784049|NCT00636506|Primary|Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool|Physicians were asked to assess the overall design compared to the current non-threaded design. Answer options: Significantly better; Better; Same; Worse; Significantly worse|For duration of surgery|Physician assessment of each patient at time of implant|||percentage of physician responses|||Number
2784050|NCT00636506|Primary|Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath|"Physicians were asked, Was it easy to remove the blue suture sheath and white needle holder? Answer options were: Yes; No, please explain"|For duration of surgery|Physician assessment of each patient at time of implant|||percentage of physician responses|||Number
2784051|NCT00636506|Primary|Comparison Rating of the New Rear Tip Extender Design to Previous Design|"Physicians were asked, Compared to AMS 700 RTE and other stackable RTE configurations, how would you rate the AMS IPP 2005 RTE configuration? Answer options were: No RTEs implanted; Much better; Somewhat better; Same; Somewhat worse; Much worse"|For duration of surgery|Physician assessment of each patient for whom they used RTEs at time of implant|||percentage of physician responses|||Number
2784052|NCT00636506|Primary|Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder|Physicians were asked to assess their satisfaction level with the new snap design rear tip extender. Answer options were: Very satisfied; Moderate satisfied; Neutral; Moderately dissatisfied; Very dissatisfied.|For duration of surgery|Physician assessment of each patient at time of implant for whom they used the RTEs (rear tip extenders)|||percentage of physician responses|||Number
2784053|NCT00636506|Primary|Ability of New Flare Design to Remain in Place|"Physicians were asked: As comparable to the previous AMS 700 reservoir, does the new flare design of the AMS IPP 2005 reservoir retain its position as implanted? Response options were: Yes; No"|For duration of surgery|Physician assessment of each patient at time of implant|||Percentage of participants|||Number
2784054|NCT00636506|Primary|Ease of Insertion of New Flare Design Reservoir|"Physicians were asked: As compared to the current 700 reservoir, how would you rate the ease of insertion of the AMS IPP 2005 reservoir? Response options were: Much easier; Somewhat easier; Same; Somewhat harder; Much harder"|For duration of surgery||||Percentage of participants|||Number
2784055|NCT00636506|Primary|Rating of the Rigidity of the Cylinders|"Physicians were asked: How would you rate the rigidity of the AMS IPP 2005 cylinders at full inflation? Response options were: Excellent; Very good; Good; Fair; Poor"|4-8 weeks follow-up|All subjects who attended the 4-8 week follow-up visit|||Percentage of participants|||Number
2784056|NCT00636506|Primary|Comparison With Other Devices for Ease of Placement|"Physicians were asked: Compared to other cylinders you have used, how would you rate the ease of proximal insertion of the AMS IPP 2005 cylinders? Response options were: Much easier; Slightly easier; Same; Somewhat more difficult; More difficult"|For duration of surgery|Physician assessment of each subject at time of implant|||Percentage of participants|||Number
2784057|NCT00636506|Primary|Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip|"Physicians were asked: How would you rate the overall ease of proximal insertion of the AMS IPP 2005 cylinders? Response options were: Very easy; Moderately easy; Neither easy nor difficult; Moderately difficult; Very difficult"|For duration of surgery|Physician assessment of each subject at time of implant|||Percentage of participants|||Number
2784058|NCT00636506|Primary|Ease of Dilation With the Reduced Angle of the Input Tubing|"Physicians were asked: As compared to other devices, did the angle of the input tubing make it easier to insert? Response options were: Yes; No/No effect"|Time of implant (surgery)|Physician assessment of each subject at time of implant|||Percentage of participants|||Number
2784059|NCT00636506|Primary|Patient Satisfaction With Deflation Mechanism|"Subjects were asked to assess: Satisfaction with softness of penis when prosthesis is flaccid. Response options were: Very satisfied; Moderately satisfied; Somewhat satisfied; Somewhat dissatisfied; Moderately dissatisfied; Very dissatisfied"|3 Months, 6 Months|All subjects who attended the 3 month and/or 6 month follow-up visit.|||Percentage of participants|||Number
2784060|NCT00636506|Primary|Ease of Training Patient to Deflate Device|"Physicians were asked to assess: Please rate the ease of training the subject to use the new AMS IPP 2005 pump in comparison to the AMS Tactile Pump. The response options were: Much easier; Somewhat easier; Same; Somewhat harder; Much harder"|4-8 weeks|All subjects who attended the 4-8 follow-up visit.|||Percentage of participants|||Number
2784061|NCT00636506|Primary|Level of Flaccidity Achieved|"Physicians were asked How would you rate the flaccidity of the AMS IPP 2005 cylinders at full deflation? Response options were: Excellent; Very good; Good; Fair; Poor."|4-8 weeks|All subjects who attended the 4-8 week follow-up visit|||Percentage of participants|||Number
2784062|NCT00636506|Primary|Ability to Deflate Device With One Hand|"Could the subject easily deflate the AMS IPP 2005 with one hand? The response options were: Yes; No; and Not Tested."|3 months, 6 months|All subjects who attended the 3 month and/or 6 month follow-up visit.|||% who selected response option|||Number
2784063|NCT00636506|Primary|Time to Complete Deflation|"Physicians were asked to assess: How much time did it take for the device to deflate? The response options were: 5-6 seconds; 7-8 seconds; 9-10 seconds; 10-15 seconds; 15-20 seconds; 20-25 seconds; 25-30 seconds; 35-40 seconds; 40-45 seconds; 45-50 seconds; More than 50 seconds, specify # of seconds"|3 months, 6 months|Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.|||Percentage of participants|||Number
2784064|NCT00636506|Primary|Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds|"Physicians were asked to assess: How long did you have to hold the deflation button for the deflation to set in motion? The response options were: 1-2 seconds; 3-4 seconds; 5-6 seconds; 7-8 seconds; 9-10 seconds; More than 10 seconds, specify seconds."|3 months, 6 months|Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.|||Percentage of Participants|||Number
2784065|NCT00636506|Primary|Subjective Force Required to Initiate Deflation|"Subjects were asked: The force required to initiate deflation was... The response options were: Too Much and Reasonable amount."|3 months, 6 months|All subjects who attended the follow-up visit|||Participants|||Number
2784066|NCT00636506|Primary|Ease of Locating the Deflation Block|"Physicians were asked: Could the deflation button be easily located? Response options were: Yes, No, and Not Tested"|4-8 week activation visit|All subjects who attended the 4-8 week activation visit|||Participants|||Number
2784067|NCT00636506|Primary|Time to Complete Inflation|"Physicians were asked: How much time was required for the subject to inflate? Response options were: 0-30 seconds, 30-60 seconds, 60-90 seconds, 90-120 seconds, 2-3 minutes, Over 3 minutes"|4-8 week activation visit|All subjects who attended the 4-8 activation visit|||Participants|||Number
2784068|NCT00636506|Primary|Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump|"Physicians were asked: Please rate the ease of training the subject to use the new AMS IPP 2005 pump in comparison to the standard AMS 700 pump. Response options were: Much easier, Somewhat easier, Same, Somewhat harder, Much harder"|4-8 week activation visit|All subjects who attended the 4-8 week activation visit|||Participants|||Number
2784069|NCT00636506|Primary|Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump|"Physicians were asked: Please rate the ease of training the subject to use the new AMS IPP 2005 pump in comparison to the AMS tactile pump. Response options were: Much easier, Somewhat easier, Same, Somewhat harder, Much harder"|4-8 weeks follow-up|All subjects who attended the 4-8 week activation visit|||Participants|||Number
2784070|NCT00636506|Primary|Ability to Inflate Device Using One Hand|Subjects were asked if they were able to inflate the device using one hand. Response options were: Yes, No|3 months, 6 months|All subjects who attended the follow-up visits|||Participants|||Number
2784071|NCT00636506|Primary|Subjective Force Required to Inflate Device|"At the 3 and 6 month visit, subjects were asked to assess the force required to initiate inflation of the device. Response options were Reasonable and Too Much"|3 months, 6 months|Subjects who attended the 3 month and/or 6 month follow-up visit|||Participants|||Number
2784072|NCT00636506|Primary|Quality of Erection (Suitability for Intercourse)|"Physicians were asked: After inflation, did the erection appear suitable for sexual intercourse? Response options were: Yes, No, Not Assessed"|4-8 weeks, 3 months, 6 months|Subjects who attended the 4-8 week activation visit.|||participants who answered yes|||Number
2784073|NCT00636506|Primary|Ease of Pumping Device to Full Erection|"Physicians were asked, Compared to current AMS 700 pumps, please rate the ease of the inflation relating to the downward orientation of the AMS IPP 2005 pump bulb. Response options were on a 5-point Likert scale - Much easier; Somewhat easier; Same; Somewhat harder; Much harder."|4-8 weeks post-op|Subjects who attended the 4-8 week activation visit|||Participants|||Number
2784074|NCT00636506|Primary|Ease of Locating the Inflation Pump Bulb|"Physicians were asked to observe patients manipulating the device and to answer the question: Could the subject easily locate the inflation pump bulb? The response options were: Yes, No, and Not Tested"|4-8 weeks|All subjects who were implanted and attended the device activation visit at 4-8 weeks post-op|||Participants who easily located pumpbulb|||Number
2784075|NCT00636441|Secondary|Patients' Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for PST of Early-stage Breast Cancer.|A short questionnaire was administered at baseline (the day chemotherapy was started) and following post-surgical medical oncology evaluation to assess the patient's understanding of the study being conducted, and the patient's expectations of the treatment. Due to space limitations, the full survey is presented in the Detailed Description.|1 year|The overall enrollment was insufficient to provide for any substantive analysis.||||||
2784076|NCT00636441|Secondary|Economic Impact of Using Genomic Assessment to Guide Management.|Economic Impact (i.e., cost of care) will be calculated by first assessing the quantity of clinical resources used by each patient in the study arm, and then assigning a cost to each resource using cost information derived from a costing study to be undertaken outside of this protocol.|5 years|Since these data were not collected, this analysis could not be done.||||||
2784077|NCT00636441|Secondary|Overall Survival|Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method.|2 years|All eligible treated patients with known follow-up status.|||Estimated % of participants surviving||95% Confidence Interval|Number
2784078|NCT00636441|Secondary|Sites of Recurrence|Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site.|10 years|All eligible treated patients. Four of these 38 participants experienced recurrence of their breast cancer; two of the four patients had multiple sites of recurrence.|||participants|||Number
2784079|NCT00636441|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval.|2 years|All eligible treated patients were used in this analysis.|||estimated % of participants disease-free||95% Confidence Interval|Number
2784093|NCT00636207|Primary|Cmax Accumulation Ratio of Montelukast - Multiple Doses|The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol|||ratio|||Number
2784094|NCT00636207|Primary|AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses|The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol|||ratio|||Number
2784080|NCT00636441|Secondary|Clinical Response Using WHO Criteria|"WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy.~Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality.~Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.~Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion."|12 weeks, 2-3 weeks after the fourth cycle of chemotherapy|All eligible treated patients were used in this analysis.|||participants|||Number
2784081|NCT00636441|Secondary|To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.|The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation.|6 months|Data from all eligible patients with non-missing values on this outcome were used.|||percentage of T2 tumor patients||95% Confidence Interval|Number
2784082|NCT00636441|Secondary|Percentage of Patients Who Had Breast-conserving Surgery With Negative Margins|The percentage of patients who had breast-conserving surgery with negative margins, measured in patients with T2 and T3 tumors classified as requiring mastectomy at baseline.|6 months|Since final margin status was not collected, this analysis could not be done.||||||
2784083|NCT00636441|Secondary|Probabilities of Being Sensitive to AC and TC as Determined by the Patient's Genomic Signatures|To determine in early stage breast cancer treated with PST whether genomic profiling can identify drug-sensitive and drug-resistant patients including a comparison of subgroups for the two individual regimens (i.e. AC and TC). To determine if the 60% cutoff for the genomic profiles is optimal in predicting the response to chemotherapy regimens.To describe the performance of the genomic profiles in assessing the relative responsiveness of: 1) Patients predicted to be resistant to both chemotherapy regimens; and 2) Patients randomly assigned to one treatment whose genomic profiles suggest receiving the other regimen (in both AC and TC subgroups).|10 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates||||||
2784084|NCT00636441|Primary|Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer|Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms.|4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks|All eligible treated patients. The three patients not included are two who had allergic reactions to the assigned treatment, and one with metastatic disease on biopsy of a spine lesion at the end of assigned treatment so never went to surgery.|||percentage of participants||95% Confidence Interval|Number
2784085|NCT00636389|Primary|A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.|Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments||||Percentage of reduction||Standard Deviation|Mean
2784086|NCT00636389|Secondary|Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H|Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H.|||Units on a Scale 1 = Best|dialyzers|Standard Deviation|Mean
2784087|NCT00636389|Primary|Comparison of Urea Removal Under Conditions of Routine Hemodialysis.|Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments||||ratio||Standard Deviation|Mean
2784088|NCT00636363|Primary|Contact Lens Deposits|Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.|At each visit for 3 months|Lens deposits, All eligible, dispensed eyes.|||Eyes|Participants||Number
2784089|NCT00636363|Primary|Subjective Responses to Comfort Related Symptoms/Complaints|Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.|Over 4 visits for the 3 month period|Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits.|||Scores on a Scale|Participants|Standard Deviation|Mean
2784090|NCT00636363|Primary|Slit-lamp Findings > Grade 2|eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.|Over 4 visits for 3 month period|Over all follow-up visits, all dispensed eyes|||participants|Participants||Number
2784091|NCT00636220|Secondary|The Effectiveness of MPC and Chembio Oral Fluid Collection Devices||1-3|||||||
2784092|NCT00636220|Primary|Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity|Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.|1 to 3 days||||samples|||Number
2784098|NCT00636207|Primary|Time to Cmax (Tmax) of Montelukast - Single Dose|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||hours||Full Range|Median
2784099|NCT00636207|Primary|Cmax of Montelukast - Multiple Doses|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL||Standard Deviation|Mean
2784100|NCT00636207|Primary|Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL||Standard Deviation|Mean
2784101|NCT00636207|Primary|AUC 0-24hr of Montelukast - Multiple Doses|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL*hr||Standard Deviation|Mean
2784102|NCT00636207|Primary|Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol|||ng/mL*hr||Standard Deviation|Mean
2784103|NCT00636207|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 7 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug|||participants|||Number
2784104|NCT00636207|Primary|Number of Participants Who Experienced At Least One Adverse Event||Up to 14 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug|||participants|||Number
2784105|NCT00636194|Secondary|Graded Slit Lamp Findings > Grade 2|Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.|2 week follow-up visit|All dispensed, completed eyes|||eyes|Participants||Number
2784106|NCT00636194|Secondary|Symptoms and Complaints|Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.|2 weeks|All eligible, dispensed eyes|||Score on a scale|Participants|Standard Deviation|Mean
2784107|NCT00636194|Primary|Subjective Assessment of Comfort and Cleanliness|Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.|7 days|All eyes|||Scores on a scale|Participants|Standard Deviation|Mean
2784108|NCT00636181|Secondary|Epworth Sleepiness Scale|"Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey.~Scores are provided on a 0 to 3 scale:~0 = no chance of dozing~= slight chance of dozing~= moderate chance of dozing~= high chance of dozing~Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness."|Baseline and 180 days|During the course of the study 24 participants withdrew from the study.|||units on a scale||Standard Deviation|Mean
2784109|NCT00636181|Secondary|Subjective Assessment of Therapy Comfort.|"visual analog scales where used to assess the question in the last month how do you rate the overall comfort of the mask?~0 = very uncomfortable to 100 = very comfortable"|30, 90, and 180 days|During the course of the study 24 participants withdrew from the study.|||units on a scale||Standard Deviation|Mean
2784110|NCT00636181|Secondary|Attitudes Toward Use|"Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance.~Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident.~Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective."|Baseline and 180 Days|During the course of the study 24 participants withdrew from the study.|||units on a scale||Standard Deviation|Mean
2784111|NCT00636181|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ)|"FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions).~Scores are provided on a 0 to 4 scale:~0- I don't do this activity for other reasons or missing response~1- Yes, extreme difficulty 4- no difficulty~The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired."|Baseline and 180 Days|During the course of the study 24 participants withdrew from the study.|||score on a scale||Standard Deviation|Mean
2784112|NCT00636181|Secondary|Psychomotor Vigilance Task - Number of Lapses|"Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses.~Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms."|Baseline and 180 Days|During the course of the study 24 participants withdrew from the study.|||number of lapses||Standard Deviation|Mean
2784113|NCT00636181|Secondary|Average Hours of Nightly Use.|The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.|180 days|During the course of the study 24 participants withdrew from the study.|||hours||Standard Deviation|Mean
2784798|NCT00631475|Secondary|Adverse Events (AE) Leading to Discontinuation of Study Drug.|Number of participants with at least one AE that led to permanent discontinuation of study treatment.|Start to end of study, up to 21 months|Study population|||participants|||Number
2784114|NCT00636181|Primary|Apnea-Hypopnea Index|The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days|Baseline and 180 Days|During the course of the study 24 participants withdrew from the study.|||events/hour||Standard Deviation|Mean
2784115|NCT00636168|Secondary|Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint|Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.|Baseline up to 2 years from randomization|All randomized participants (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized participants (ITT) with a measurement at the timepoint were analyzed.|||units on a scale||Standard Deviation|Mean
2784116|NCT00636168|Secondary|Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events|P-Y = person-years of exposure. Incidence rate per 100 person-years of exposure (IR/100 P-Y) was calculated as event count * 100 /person-years of exposure. MedDRA Version: 19. Duplicate AEs have been eliminated and overlapping and contiguous occurrences of the same event have been collapsed.|Day 1 up to 70 days after last dose; up to 5 years|All participants who received at least one dose of ipilimumab or placebo, adjusted for person-years (P-Y) of exposure; P-Y=467.4; P-Y=781.7 for ipilimumab and placebo, respectively.|||Events per 100 person-years of exposure|||Number
2784117|NCT00636168|Secondary|Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study|AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|SAEs and NSAEs: Day 1 up to 70 days after last dose(safety window). Deaths: All deaths regardless of 70 day safety window.Up to 10 years|Safety population: All randomized participants who received at least 1 dose of study therapy|||Participants|||Count of Participants
2784118|NCT00636168|Secondary|Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population|AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator's assessment of immune-mediated etiology [excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to 70 days after last dose; up to 5 years|Safety population: All randomized participants who received at least 1 dose of study therapy|||Participants|||Count of Participants
2784119|NCT00636168|Secondary|Rate of Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.Yearly survival rates, e.g. at 3 years, defined as the probability that a participant was alive at 3 years following randomization, were estimated via the Kaplan-Meier method|From date of randomization to date of death, assessed up to 9 years|Intent to Treat Population: All randomized participants,analyzed in the arm to which they were allocated by randomization|||Percentage of participants||95% Confidence Interval|Number
2784120|NCT00636168|Secondary|Overall Survival in the Intent to Treat (ITT) Population|OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.|From June 2008 to January 2016 (approximately 90 months)|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||Months||95% Confidence Interval|Median
2784121|NCT00636168|Secondary|Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population|Yearly distant metastasis-free survival rates, e.g. at 1 year, defined as the probability that a participant was alive at 1 year following randomization, were estimated via the Kaplan-Meier method. Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment. Participants with disease at baseline were considered to have an event on the day of randomization.|At years 1, 2, 3, 4 and 5|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||Percentage of participants||95% Confidence Interval|Number
2784198|NCT00635609|Primary|Successful Outcome According to Investigator's Global Assessment (IGA)|The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.|baseline and 12 weeks||||participants|||Number
2784122|NCT00636168|Secondary|Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|DMFS was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (2 weeks) for 3 years, then every 24 weeks until documented distant progression.|From June 2008 to January 2016 (approximately 90 months)|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||Participants|||Count of Participants
2784123|NCT00636168|Secondary|Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Distant Metastasis-Free Survival (DMFS) was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A participant who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|From June 2008 to January 2016 (approximately 90 months)|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||Months||95% Confidence Interval|Median
2784124|NCT00636168|Primary|Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population|Yearly recurrence-free survival rates, eg. at 1 year, defined as the probability that a participant was recurrence-free at 1 year following randomization, were estimated for each treatment group using the Kaplan-Meier product-limit method, along with their corresponding log-log transformed 95% confidence intervals. RFS was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. CT and MRI were mandatory to establish recurrence.|At years 1, 2, and 3|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||Percentage of participants||95% Confidence Interval|Number
2784125|NCT00636168|Primary|Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence was defined as appearance of one or more new melanoma lesions: local, regional or distant metastasis. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. A participant who died without reported recurrence was considered to have recurred on the date of death. Disease was assessed at randomization and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||Participants|||Count of Participants
2784126|NCT00636168|Primary|Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A participant who died without reported recurrence was considered to have recurrence on the date of death. For those participants who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Participants with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.|Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization|||months||95% Confidence Interval|Median
2784127|NCT00636155|Secondary|Overall Survival||5 years|All patients who received treatment|||months||95% Confidence Interval|Median
2784128|NCT00636155|Secondary|Progression Free Survival|Progression is defined as at least one of the following: 1) ≥ 50% increase in the sum of the products of at least two lymph nodes one two consecutive determinations (at least one node must be ≥ 2 cm); appearance of new palpable lymph nodes, 2) ≥ 50% increase in the size of the liver and/or spleen; appearance of palpable hepatomegaly or splenomegaly, which was not previously present, 3) ≥ 50% increase in the absolute number of circulating lymphocytes to at least 5,000/µl or 4)Transformation to a more aggressive histology.|5 years|All patients who received treatment|||months||95% Confidence Interval|Median
2784199|NCT00635570|Post-Hoc|Continuation Rate|Rate of intention to continue the contraceptive method at 6 months|at 6 month (3 month after the end of the study period)|At 6 months, four from the contraceptive vaginal ring group and three from the oral contraceptive pill group did not complete the 6-month survey and thus were excluded from analysis.|||Percentage of Participants|||Number
2786389|NCT00619645|Secondary|Number of Patients Without Progression After Day 100 Transplant|All patients will be followed for progression for 24 months after their day 100 transplant.|24 months after day 100 transplant|This outcome was not collected/analyzed||||||
2784129|NCT00636155|Primary|Number of Patients With an Overall Response (Complete Response + Partial Response)|Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.|every 3 cycles|Patients completing at least 2 cycles of treatment|||participants|||Number
2784130|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||whole blood clearance B2-microglobulin||Standard Error|Mean
2784131|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||KoA for b2-microglobulin (mL/min)||Standard Error|Mean
2784132|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||whole blood phosphorus clearance mL/min||Standard Error|Mean
2784133|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||KoA for Phosphorus (mL/min)||Standard Error|Mean
2784134|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)||||Whole blood urea clearance (mL/min)||Standard Error|Mean
2784135|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.|KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.|During the third treatment with each dialyzer (one time during each trial period week)||||KoA for urea (mL/min)||Standard Error|Mean
2784136|NCT00635999|Secondary|Within-group Change Represented as Cohen's d Effect Sizes|Cohen's d within-group effect sizes comparing pre-therapy assessment to assessment at 10-14 days after last therapy session, at 6-month follow-up, at 12-month follow-up, and at 24-month follow-up. Findings reported in table are Cohen's d effect sizes averaged over Hamilton Anxiety Scale (scores ranging from 0-56, higher scores mean more anxiety), the Assessor Severity Scale (scores ranging from 0-8, higher scores mean more severity), and the State-Trait Anxiety Inventory-Trait version (scores ranging from 20-80, higher scores mean more state anxiety). The within-group effective sizes are the posttherapy [or follow-up] mean minus pretherapy mean divided by the pretherapy standard deviation.|10-14 days after last therapy session and months 6, 12, and 24 following last therapy session|People who completed treatment|||Cohen's d within group effect size|||Number
2784137|NCT00635999|Primary|High End State Function|Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)|10-14 days after last therapy session and months 6, 12, and 24 following last therapy session|People who completed treatment|||% people meeting high endstate status|||Number
2784138|NCT00635882|Other Pre-specified|Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline||||ppb||Standard Deviation|Mean
2784139|NCT00635882|Secondary|Change From Baseline in PM PEF at Days 1-15||Baseline and Days 1-15|All randomized participants|||liters/minute||Standard Deviation|Mean
2784140|NCT00635882|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15||Baseline and Days 2-15|All randomized participants|||liters/minute||Standard Deviation|Mean
2784141|NCT00635882|Secondary|Change From Baseline in PM Total Asthma Symptom Score at Days 1-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 1-15|All randomized participants|||units on a scale||Standard Deviation|Mean
2784142|NCT00635882|Secondary|Change From Baseline in AM Total Asthma Symptom Score at Days 2-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 2-15|All randomized participants|||units on a scale||Standard Deviation|Mean
2784143|NCT00635882|Secondary|Mean Change From Baseline to Day 15 of Mannitol Challenge|Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).|Baseline to Day 15|All randomized participants|||milligrams||Standard Deviation|Mean
2784144|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)||Baseline to Day 14|All randomized participants|||percentage of Sputum Eosinophil Count||Standard Deviation|Mean
2784145|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 7 in eNO Ppb||Baseline to Day 7|All Randomized Participants|||percentage of eNO||Standard Deviation|Mean
2784146|NCT00635882|Primary|Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline to Day 14|All Randomized Participants|||percentage of eNO||Standard Deviation|Mean
2784200|NCT00635570|Secondary|Continuation Rate|Rate of intention to continue the contraceptive method at 3 months|at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)|||Percentage of Participants|||Number
2784147|NCT00635830|Primary|Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination||||Participants|||Number
2784148|NCT00635817|Post-Hoc|Percentage of Participants With a Decrease From Baseline in the Ratio of Bone Age to Chronological Age at Month 6 Compared to Baseline|The ratio at baseline or Month 6 was calculated as bone age at baseline or Month 6/chronological age at baseline or Month 6. The percentage of participants with a decrease in the ratio was calculated as a simple percentage for each dose group. Observed data were used with no imputation for missing data. The baseline time frame was increased from the secondary outcome in this analysis to include all participants with a bone age radiograph at screening. This analysis was performed after the clinical study report was completed & is included to match the FDA package insert.|Baseline to Month 6|The baseline time frame was increased from the secondary outcome to this analysis to include all participants with a bone age radiograph at screening. This analysis was performed post hoc to match the FDA package insert.|||Percentage of Participants|||Number
2784149|NCT00635817|Post-Hoc|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (< 4 mIU/mL) From Month 2 Through Month 6 (Simple Percentage With Binomial Exact Confidence Intervals)|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a GnRHa stimulation test at Mo 2, 3, and 6. A simple percentage and binomial exact confidence intervals were used in this analysis. Participants who withdrew with luteinizing hormone that remained suppressed were counted as a success. This analysis was performed after the clinical study report was completed and is included to match the FDA package insert.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
2784150|NCT00635817|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6|The ratio at Month 6 was calculated as (bone age at Month 6 - bone age at baseline)/(chronological age at Month 6 - chronological age at baseline). Observed data were used with no imputation for missing data. Baseline bone-age radiograph was performed at or within 3 months of the Screening Visit.|Baseline to Month 6|Participants must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Ratio||Standard Deviation|Mean
2784151|NCT00635817|Secondary|Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6|The growth rate at baseline was the growth rate during the last year before the start of treatment and was calculated with the measurement closest to Day -336 (before Day -30) and the measurement up to Day 1. Growth rate at Month 6 was defined as the ratio of the change in height from Day 1 to the change in chronological age, with an approximate 6-month interval between the 2 height measurements. Observed data were used with no imputation for missing data.|Baseline and Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||cm/year||Standard Deviation|Mean
2784152|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6|Percentage of participants with suppression of genital development and testicular volume, out of the number of boys with pubertal staging of genital development or testicular volume (n/N%). Only boys are analyzed in this outcome measure. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
2784153|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6|Percentage of participants with suppression of breast development, out of the number of girls with pubertal staging of breast development (n/N%). Only girls are analyzed in this outcome measure. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
2784154|NCT00635817|Secondary|Peak-stimulated Luteinizing Hormone Concentration by Visit|Observed data were used with no imputation for missing data.|Baseline, Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||mIU/mL||Standard Deviation|Mean
2784155|NCT00635817|Secondary|Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit|Percentage of participants with suppression of testosterone, out of the number of boys with at least 1 testosterone measurement at each visit (n/N%). Only boys are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
2784156|NCT00635817|Secondary|Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit|Percentage of participants with suppression of estradiol, out of the number of girls with at least 1 estradiol measurement at each visit (n/N%). Only girls are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
2784157|NCT00635817|Primary|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone >= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.|||Percentage of Participants||95% Confidence Interval|Number
2784158|NCT00635804|Secondary|Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days|For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was calculated at each time point. The response for that participant was defined as: − (postbaseline time point − baseline) at the time point with the lowest HCV RNA level.|Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7|Treated HCV+ participants in Part II with available HCV RNA data. 800 mg dose group contained members of Panels E and F. No healthy participants from Part 1 (Panels A, B, C, or D) were assessed for this outcome measure.|||log(IU/ml)||95% Confidence Interval|Mean
2784159|NCT00635804|Secondary|C12hr Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||ratio||90% Confidence Interval|Geometric Mean
2784160|NCT00635804|Secondary|Cmax Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||ratio||90% Confidence Interval|Geometric Mean
2784161|NCT00635804|Secondary|AUC (0-12hr) Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||ratio||90% Confidence Interval|Geometric Mean
2784162|NCT00635804|Secondary|Apparent Half-Life (t ½) of MK-3281|Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||hour||Standard Deviation|Mean
2784163|NCT00635804|Secondary|Time To Reach Cmax (Tmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||hour||Full Range|Median
2784164|NCT00635804|Secondary|12-Hour Concentration of MK-3281 in Plasma (C12hr)|Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||μM||Geometric Coefficient of Variation|Geometric Mean
2784165|NCT00635804|Secondary|Maximum Plasma Concentration (Cmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||μM||Geometric Coefficient of Variation|Geometric Mean
2784201|NCT00635570|Secondary|Satisfaction Rate||at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)|||Percentage of Participants|||Number
2784166|NCT00635804|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281|Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2784167|NCT00635804|Primary|Number of Participants Who Discontinued Study Medication Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants|||participants|||Number
2784168|NCT00635804|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants|||participants|||Number
2784169|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 53|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 53|||Percent change||Full Range|Median
2784170|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 49|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 49|||Percent change||Full Range|Median
2784171|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 45|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 45|||Percent change||Full Range|Median
2784172|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 41|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 41|||Percent change||Full Range|Median
2784173|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 37|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 37|||Percent change||Full Range|Median
2784174|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 33|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 33|||Percent change||Full Range|Median
2784175|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 29|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 29|||Percent change||Full Range|Median
2786477|NCT00619112|Secondary|Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued||From beginning of voluntarily temozolomide discontinued up to 6 months||||Participants|||Count of Participants
2784176|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 25|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 25|||Percent change||Full Range|Median
2784177|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 21|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 21|||Percent change||Full Range|Median
2784178|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 17|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 17|||Percent change||Full Range|Median
2784179|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 13|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 13|||Percent change||Full Range|Median
2784180|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 9|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 9|||Percent change||Full Range|Median
2784181|NCT00635778|Secondary|Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 5|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 5|||Percent change||Full Range|Median
2784182|NCT00635778|Secondary|Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer|The formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 3, Week 5, pre-dose every 8 subsequent weeks, and end of treatment (post-study: 4 weeks after last dose of study drug). Positive HAHA status for a participant is defined as testing positive on both the screening and immunodepletion assays at one or more visits.|Prior to second and subsequent doses of study drug (Up to 1 year post-first dose)|All participants who received one dose of study therapy.|||Participants|||Count of Participants
2784183|NCT00635778|Secondary|Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1|IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.|Baseline and Week 1|All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 1.|||Percent change||Full Range|Median
2784184|NCT00635778|Secondary|Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)|Complete Response (disappearance of all target lesions) or Partial Response (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) using Response Criteria in Solid Tumors (RECIST). Tumor response was assessed prior to first dose and every 8 weeks beginning pre-dose of Week 9 for up to 18 months. The best response out of all measurements for each participant was used for determining CR and PR.|Up to 18 months post first dose of study drug|All participants who received at least one dose of study therapy.|||Participants|||Count of Participants
2784202|NCT00635570|Primary|Adherence Rate (Rate of Perfect Method Use)|"Perfect use was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles"|For the first 3 months||||Percentage of Participants|||Number
2784258|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784185|NCT00635778|Primary|Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)|Dose-limiting toxicities (DLT) were assessed and graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE). A DLT was defined as the occurrence of any of the following events, that were judged by the study investigator, to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5 degrees Celsius; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity (except alopecia and inadequately treated diarrhea, nausea, and vomiting, and hyperglycemia lasting less than 5 days; and Grade 3 or greater hyperglycemia lasting for more than 5 days in spite of optimal medical management.|The entire treatment period (Up to 18 months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2784186|NCT00635778|Primary|Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose|Blood samples were obtained for analysis of steady-state serum concentration of dalotuzumab at 336 hours (C336) after the first maintenance dose of dalotuzumab. The C336 of dalotuzumab after intravenous administration is presented.|2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)|All participants who received dalotuzumab and had blood samples drawn for pharmacokinetic (PK) analyses.|||μg/mL||Standard Deviation|Mean
2784187|NCT00635739|Secondary|Lean Mass|Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.|Baseline and follow up (6 months)|5 subjects were not included in follow up analysis|||Kg||Standard Deviation|Mean
2784188|NCT00635739|Primary|1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press|The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.|Baseline and follow up (6 months)|5 subjects were not included in follow up analysis|||N||Standard Deviation|Mean
2784189|NCT00635700|Secondary|Improvement SOPS Total Score||8 weeks|||||||
2784190|NCT00635700|Primary|Conversion to Psychosis|Conversion to psychosis according to the SIPS require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.|6 months|In another case assigned to active ziprasidone, ratings conducted at a follow-up conversion visit suggested retrospectively that the patient had been already psychotic prior to enrollment. The study’s blinded DSMB was consulted, and in a split 4-2 vote recommended retaining the patient as randomized in the primary analysis.|||participants|||Number
2784191|NCT00635661|Primary|Stroke Rehabilitation Assessment of Movement (STREAM)|The STREAM measures quality of movements in the arm and leg, and the quality of mobility during important functional tasks, such as walking 10 feet. There are 10 items for each of the 3 assessments (arm, leg and mobility), resulting in a total of 30 items. Each item is rated on a scale of 0 = unable to perform, to 2 or 3 = normal movement. Ratings on the 30 items are added together for a total score which is divided by the total number of items resulting in a percentage score: minimum=0, maximum=100, range=100 The score reported is mean +/- standard deviation of discharge STREAM scores.|4 weeks|34 participants were enrolled, 4 participants were dropped from the study resulting in 30 participants providing data for analysis.|||units on a scale||Standard Deviation|Mean
2784192|NCT00635648|Secondary|Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis|"Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions.~Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response."|First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|Of the 63 enrolled participants, one participant with invasive candidiasis who withdrew consent before completing the efficacy assessment was not included in the efficacy analyses.|||Participants|||Number
2784193|NCT00635648|Secondary|Number of Participants Who Discontinued Due to a Drug-related Adverse Event|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)||||Participants|||Number
2784194|NCT00635648|Secondary|Number of Participants With One or More Drug-related Adverse Events|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)||||Participants|||Number
2784195|NCT00635648|Primary|Number of Participants With One or More Drug-related Serious Adverse Events|"A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention.~A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile."|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)||||Participants|||Number
2784196|NCT00635609|Primary|Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks|intention to treat (ITT)|||acne lesion count||Standard Deviation|Mean
2784197|NCT00635609|Secondary|Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks||||Acne lesion count||Standard Deviation|Mean
2784203|NCT00635492|Secondary|Percentage of Patients Hospitalized Between Baseline and 24 Months|Percentage of Patients Hospitalized Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
2784204|NCT00635492|Secondary|Number of Contacts With Health Care Providers Between Baseline and 24 Months|Number of contacts with Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||number of contacts||Standard Deviation|Mean
2784205|NCT00635492|Secondary|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
2784206|NCT00635492|Secondary|Factors Associated With Treatment Change in Exenatide BID Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||hazard ratio||95% Confidence Interval|Number
2784207|NCT00635492|Secondary|Factors Associated With Treatment Change in Insulin Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||hazard ratio||95% Confidence Interval|Number
2784208|NCT00635492|Secondary|Reasons for Discontinuation of Baseline Regimen|Reasons for Discontinuation of Baseline Regimen|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||number of patients|||Number
2784209|NCT00635492|Secondary|Incidence of Hypoglycemia Between Baseline and 24 Months|Incidence of Hypoglycemia between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
2784210|NCT00635492|Secondary|Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months|Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
2784211|NCT00635492|Secondary|Changes in Weight From Baseline to Month 24|Changes in Weight From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||kg||Standard Deviation|Mean
2784212|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
2784213|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of patients|||Number
2784214|NCT00635492|Secondary|Changes in HbA1c From Baseline to Month 24|Changes in HbA1c From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."|||percentage of total hemoglobin||Standard Deviation|Mean
2784242|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Investigator|Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure|||participants|||Number
2784215|NCT00635492|Secondary|Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline|Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||mmol/L||Standard Deviation|Mean
2784216|NCT00635492|Secondary|Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline|Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||participants|||Number
2784217|NCT00635492|Secondary|Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline|Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|4 weeks prior to Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||tests/week||Standard Deviation|Mean
2784218|NCT00635492|Secondary|Higher Random Glucose Associated With Treatment Choice at Baseline|Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|6 months prior to Baseline||||mmol/L||Standard Deviation|Mean
2784219|NCT00635492|Secondary|Disinhibited Eating Associated With Treatment Choice at Baseline|Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.|||units on a scale||Standard Deviation|Mean
2784220|NCT00635492|Secondary|Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||years||Standard Deviation|Mean
2784221|NCT00635492|Secondary|Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline|Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||percent of hemoglobin||Standard Deviation|Mean
2784222|NCT00635492|Secondary|Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.|||kg/m^2||Standard Deviation|Mean
2784243|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Participants|Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure|||participants|||Number
2785025|NCT00629525|Secondary|Pathologic Response|Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index|Patients were followed for a median of 315 days|Only subjects with paired samples were included in this analysis|||participants|||Number
2784223|NCT00635492|Primary|Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.|"The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.~Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.~Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:~Insulin:~Addition of a new medication for the treatment of type 2 diabetes~A change in the number of times insulin is administered per day~Discontinuation of any insulin initiated at baseline~Substitution of a human insulin for an analogue insulin or vice-versa.~Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.~Exenatide:~Addition of a new medication for the treatment of type 2 diabetes~Discontinuation of exenatide."|Month 24|All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.|||probability (%)||95% Confidence Interval|Number
2784224|NCT00635479|Primary|Number of Participants With Wound Infections||Until wound healed, up to 1 year||||participants|||Number
2784225|NCT00635453|Other Pre-specified|Food Consumption|Effectiveness of a nutrition advice programme will be evaluated by comparing the food consumption differences between the intervention and control groups (nutrient and grams of non recommended food)|Six and twelve months, three and six years after the beginning of the study|||||||
2784226|NCT00635453|Secondary|Number of Overweight Children at 6 Years of Age|The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 6 years of age|6 years after the beginning of the study|Analyzed only for participants who underwent anthropometric assessment|||Participants|||Count of Participants
2784227|NCT00635453|Secondary|Number of Overweight Children at 3 Years of Age|The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 3 years of age|3 years after the beginning of the study|Analyzed only for participants who underwent anthropometric assessment|||Participants|||Count of Participants
2784228|NCT00635453|Secondary|Number of Overweight Children at 12 Months of Age|The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 12 months of age|12 months after the beginning of the study|Analyzed only for participants who underwent anthropometric assessment|||Participants|||Count of Participants
2784229|NCT00635453|Primary|Exclusive Breastfeeding at Four Months of Age|Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth.|Six months after the beginning of the study||||Participants|||Count of Participants
2784230|NCT00635427|Secondary|Percentage Change From Baseline to 24 Months in Normalized Spleen Volume for Each Treatment Group||Baseline to 24 months||||Precent (%) change||95% Confidence Interval|Mean
2784231|NCT00635427|Secondary|Change From Baseline to 24 Months in Normalized Liver Volume for Each Treatment Group||Baseline to 24 months||||% Body weight||95% Confidence Interval|Mean
2784232|NCT00635427|Secondary|Change From Baseline to 24 Months in Platelet Counts for Each Treatment Group||Baseline to 24 months||||(10^9/L)||95% Confidence Interval|Mean
2784233|NCT00635427|Secondary|Change From Baseline to 24 Months in Hemoglobin Concentration for Each Treatment Group||Baseline to 24 months||||(g/dL)||95% Confidence Interval|Mean
2784234|NCT00635427|Primary|Overall Summary of Treatment Emergent Adverse Events|Safety was evaluated by an analysis of adverse events (AEs), concomitant medication use, clinical laboratory tests, vital signs during the infusion of study drug, physical examination, and the development of anti-velaglucerase alfa. No formal comparisons or statistical tests were applied for the safety analyses, including for differences between the groups.|Baseline to termination of study|All participants who received at least 1 infusion (full or partial) of study drug were evaluated for safety (ie, were included in the safety population). There were 95 participants in the safety population.|||Participants|||Number
2784235|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|12 months after cesarean delivery|Analysis only done on subjects completing 12-month visit|||participants|||Number
2784236|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|6 months after cesarean delivery|Analysis only done on subject completing six-month visit|||participants|||Number
2784237|NCT00635362|Secondary|Perforation Rates||12 months after cesarean delivery||||participants|||Number
2784238|NCT00635362|Secondary|Rates of Expulsion of the LNG-IUS||12 months after cesarean delivery||||participants|||Number
2784239|NCT00635362|Primary|Use of the LNG-IUS for Contraception||12 months after cesarean delivery||||participants|||Number
2784240|NCT00635349|Secondary|Number of Participants With Categorical Tenderness|Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||participants|||Number
2784241|NCT00635349|Secondary|Number of Participants With Categorical Swelling|Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||participants|||Number
2784244|NCT00635349|Secondary|Number of Participants With Pain Relief|Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||participants|||Number
2784245|NCT00635349|Secondary|Change From Day 29 in Pain Intensity Score at Day 85|Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2784246|NCT00635349|Primary|Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85|The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.|||units on a scale||Standard Deviation|Mean
2784247|NCT00635232|Secondary|The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.||12 weeks|Full analysis set (LOCF)|||participants|||Number
2784248|NCT00635232|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks||||mm Hg||Standard Deviation|Mean
2784249|NCT00635232|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks|The primary efficacy population was the Full Analysys Set (FAS) population= all randomized subjects who took at least one dose of the assigned study drug and had both baseline and post-baseline mean seated SBP. Both LOCF and observed-data set approach were performed.|||mm Hg||Standard Deviation|Mean
2784250|NCT00635219|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction."|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784251|NCT00635219|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784252|NCT00635219|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784253|NCT00635219|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF; Logistic Regression|||percentage of patients|||Number
2784254|NCT00635219|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784255|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20||Baseline and Week 8|Patients With Baseline HAM-A Total Score >=20: FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784256|NCT00635219|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
2784257|NCT00635219|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS; LOCF; Logistic Regression|||percentage of patients|||Number
2784284|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 2||||units on a scale||Standard Deviation|Mean
2784259|NCT00635219|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)|||units on a scale||Standard Error|Mean
2784260|NCT00635167|Secondary|Patient Tolerance of TRUS Evaluation During/After Radiation Treatment||1 year|This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.||||||
2784261|NCT00635167|Secondary|Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer||1 year|This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.||||||
2784262|NCT00635167|Primary|Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment||1 year|This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.||||||
2784263|NCT00635154|Secondary|Duration of Response|Duration of response is defined for all evaluable participants (receiving Anakinra alone or in combination with Dexamethasone) who have achieved an objective response as the date at which the participants status was first noted to be MR or better to the date progression is documented or the date of last follow-up.|From first documentation of response to progression or last follow-up (up to 5 years)|Participants (receiving Anakinra alone or in combination with Dexamethasone) who achieved a MR or better were analyzed.|||months||95% Confidence Interval|Median
2784264|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|every cycle during treatment (up to 5 years)|Only participants who received Anakinra with low or high dose dexamethasone were analyzed.|||participants|||Number
2784265|NCT00635154|Secondary|Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone|"PFS was defined as the time from registration to progression or death due to any cause.~Progression is defined the same as outcome measure #3."|Time from registration to progression or death (up to 5 years)|PFS results were published in Mayo Clin Proc, Feb 2009. 47 patients were analyzed for this publication.|||months||95% Confidence Interval|Median
2784266|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|Duration of treatment (up to 5 years)||||participants|||Number
2784267|NCT00635154|Secondary|Number of Patients Who Are Progression-free and Alive at 6 Months|"Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response:~Serum M-component (absolute increase >=1.0 g/dL)~Urine M-component (absolute increase >=200 mg/24 hours)~An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells)~Development of new bone lesions or soft tissue plasmacytomas."|at 6 months||||participants|||Number
2784268|NCT00635154|Secondary|Number of Patients With Response to Treatment With Dexamethasone and Anakinra|"Response on 2 consecutive months during active treatment with anakinra alone or in combination with dexamethasone.~Response criteria is the same as in Primary Outcome Measure."|During Active treatment (up to 5 years)|Only participants who received Anakinra with dexamethasone were analyzed.|||participants|||Number
2784269|NCT00635154|Primary|Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone|"Response Definitions:~Complete Response(CR):disappearance of M-Protein from serum & urine and immunofixation, <5% bone marrow(BM) plasma cells & disappearance of soft tissue plasmacytomas(STP);~Very Good Partial Response(VGPR):>=90% decrease in serum M-Protein, Urine M-protein <100 mg/24 hours, <=5% BM plasma cells, disappearance of STP;~Partial response(PR):>=50% reduction in serum M-protein, >=90% decrease in Urine M-protein or <200 mg/24 hours & >=50% decrease in STP;~Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein & 25-49% decrease in STP"|6 months|Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.|||participants|||Number
2784270|NCT00635128|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire booster period (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2784271|NCT00635128|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|AEs results are presented for all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2785026|NCT00629525|Primary|Biochemical Response Rate|Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.|Patients were followed for a median of 315 days||||participants|||Number
2784272|NCT00635128|Secondary|Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).|One month after booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2784273|NCT00635128|Secondary|Anti-Polio 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
2784274|NCT00635128|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2784275|NCT00635128|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2784276|NCT00635128|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2784277|NCT00635128|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2784278|NCT00635128|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids|Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.|Prior to (Month 0) and one month after (Month 1) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
2784279|NCT00635128|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2784280|NCT00635128|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2784281|NCT00635128|Primary|Number of Subjects With Any Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2784282|NCT00635102|Secondary|Hopkins Verbal Learning Task - Delay Recall - 90 Minutes|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (delay recall - 30 minutes after Trials 1-3 were given) (0 No words recalled - 12 all words recalled)|90 minutes||||units on a scale||Standard Deviation|Mean
2784283|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 3||||units on a scale||Standard Deviation|Mean
2785027|NCT00629499|Secondary|Overall Survival||18 Months|||||||
2784285|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 1||||units on a scale||Standard Deviation|Mean
2784286|NCT00635102|Secondary|Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure Vigilance - (A-Prime score range 0 minimum - 1 maximum - The higher number the better the performance)|30 minutes||||units on a scale||Standard Deviation|Mean
2784287|NCT00635102|Secondary|Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure distractibility - (A-Prime score range 0 minimum - 1 maximum - the higher number the better the performance)|30 minutes||||units on a scale||Standard Deviation|Mean
2784288|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|120 minutes||||units on a scale||Standard Deviation|Mean
2784289|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes||||units on a scale||Standard Deviation|Mean
2784290|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|30 minutes||||units on a scale||Standard Deviation|Mean
2784291|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
2784292|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|Baseline||||units on a scale||Standard Deviation|Mean
2784293|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|120 minutes||||units on a scale||Standard Deviation|Mean
2784294|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes||||units on a scale||Standard Deviation|Mean
2784295|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|30 minutes||||units on a scale||Standard Deviation|Mean
2784296|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
2784297|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|Baseline||||units on a scale||Standard Deviation|Mean
2784298|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|120 minutes||||units on a scale||Standard Deviation|Mean
2784299|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes||||units on a scale||Standard Deviation|Mean
2784300|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|30 minutes||||units on a scale||Standard Deviation|Mean
2784301|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
2784302|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|Baseline||||units on a scale||Standard Deviation|Mean
2784303|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|120 minutes||||units on a scale||Standard Deviation|Mean
2784304|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes||||units on a scale||Standard Deviation|Mean
2784305|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|30 minutes||||units on a scale||Standard Deviation|Mean
2785028|NCT00629499|Secondary|Disease-free Survival||18 Months|||||||
2786478|NCT00619112|Secondary|Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide||Within 6 months after 6th adjuvant course of temozolomide||||Participants|||Count of Participants
2784306|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
2784307|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|Baseline||||units on a scale||Standard Deviation|Mean
2784308|NCT00635102|Secondary|Visual Analog Scales (VAS) - 120 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|120 minutes||||units on a scale||Standard Deviation|Mean
2784309|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes||||units on a scale||Standard Deviation|Mean
2784310|NCT00635102|Secondary|Visual Analog Scales (VAS) - 30 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|30 minutes||||units on a scale||Standard Deviation|Mean
2784311|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes prior to Glycine infusion||||units on a scale||Standard Deviation|Mean
2784312|NCT00635102|Secondary|Visual Analog Scales (VAS) - Baseline|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|Baseline||||units on a scale||Standard Deviation|Mean
2784313|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|120 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
2784314|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
2784315|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|30 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
2784316|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes prior to Glycine infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
2784317|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|||units on a scale||Standard Deviation|Mean
2784318|NCT00635102|Secondary|Number of Drinks Felt Consumed at 120 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|120 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||Number of Drinks Felt Consumed||Standard Deviation|Mean
2784319|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||Number of Drinks Felt Consumed||Standard Deviation|Mean
2784320|NCT00635102|Secondary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||Number of Drinks Felt Consumed||Standard Deviation|Mean
2784321|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes prior to Glycine infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|||drinks felt consumed||Standard Deviation|Mean
2784322|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 120 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol -7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|120 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
2784323|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol -7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
2784324|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 30 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol -7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
2784595|NCT00633087|Primary|To Determine the Biochemical Response of This Regimen in Patients With HRPC|A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.|5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
2784325|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol -7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes prior to Glycine infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
2784326|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol -7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|||units on a scale||Standard Deviation|Mean
2784327|NCT00635089|Secondary|Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)|Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|Participants with an assessment.|||participants|||Number
2784328|NCT00635089|Secondary|Reslizumab Serum Concentrations|Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.|Before treatment (within 3 hours) and after treatment (within 3 hours after end of infusion) for doses at Weeks 8 and 12; within 6 days after either dose at Weeks 8 or 12; 2 to 4 weeks after dose at Weeks 8 or 12; and at premature withdrawal.|Number of participants with measurable concentration data at each dose level and overall.|||µg/mL|Concentrations|Standard Deviation|Mean
2784329|NCT00635089|Secondary|Dietary Question Responses at Endpoint|Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)|Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)|Number of Participants Analyzed=all participants (n=190). The denominator for follow-up questions is the number of participants responding ‘No’ to the question “Have you maintained your diet since the beginning of the study?” (n=63).|||participants|||Number
2784330|NCT00635089|Secondary|Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores|The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.|Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)|n=participants with an assessment for the given score at Baseline and Endpoint.|||units on a scale||Standard Deviation|Mean
2784331|NCT00635089|Secondary|Physician's EoE Global Assessment Over Time|The data from the participant's/parent's EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician's EoE Global Assessment. All components of the patient's EoE Symptom Assessment were used by physicians to determine the Physician's EoE Global Assessment.|Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)|The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.||||||
2784332|NCT00635089|Secondary|Participant's EoE Predominant Symptoms Over Time|The data from the patient's/parent's eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant's/parent's EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week's EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.|Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)|The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.||||||
2784333|NCT00635089|Primary|Therapeutic Classification of Concomitant Medications in at Least 10% of Participants|Number of participants receiving therapeutic classes of concomitant medications.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
2784355|NCT00634933|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784334|NCT00635089|Primary|Infusion Site Evaluations|The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.|Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months)|Number of Participants Analyzed= all participants in study (n=190); n=number of participants graded at given time point.|||participants|||Number
2784335|NCT00635089|Primary|Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint|HEENT=head, eyes, ears, nose and throat.|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
2784336|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value|Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
2784337|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality|Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)||||participants|||Number
2784338|NCT00635089|Primary|Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value|Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).|From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)|Participants with a postbaseline result for hematology tests.|||participants|||Number
2784339|NCT00635089|Secondary|Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts|The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.|Baseline, Week 16 or early withdrawal (if before Week 16)|Participants with an assessment at Baseline and Week 16 (or early withdrawal).|||eosinophils/high power field (hpf)||Standard Deviation|Mean
2784340|NCT00635089|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs|An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.|From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)|Three additional participants experiences anaphylactic reactions that were upgraded to serious AEs after database lock. These 3 participants are not included in this table summary.|||participants|||Number
2784341|NCT00635050|Secondary|Assess Toxicities of Regimen Including Hand Foot Syndrome|patients who receive any treatment drugs will be included for toxicity evaluation. Adverse events will be summarized with frequencies and proportions of study participants exhibiting adverse events. The severity of adverse events (none, mild, moderate, severe) and their relationship to the product will be presented.|Baseline, every 2 weeks during treatment, and at completion of therapy. Every 3 weeks during postoperative Avastin||||participants|||Number
2784342|NCT00635050|Secondary|Calculate Progression Free Survival|Progression free survival (PFS) will be defined as survival without local recurrence of breast cancer and without the development of distant metastasis. Death from any cause will be included as an event. The Kaplan-Meier nonparametric method will be used to estimate progression free survival.|5 years|operative specimens after treatment of participants|||participants|||Number
2784343|NCT00635050|Secondary|Number of Participant With Clinical or Subclinical Cardiotoxicity|Left ventricular ejection fraction (LVEF) measurements and clinical examination at baseline and at end of therapy will be used.|Prior to treatment and at completion of chemotherapy||||participants|||Number
2784344|NCT00635050|Primary|Rate of Achievement of Pathological Complete Response (pCR)|Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes.|After completion of at least 8 of the 9 chemotherapy doses and operation.|Intention to treat, i.e., all participants entered were included in the analysis.|||pathology specimens from participants|||Number
2784345|NCT00635024|Secondary|Number of Participants With Severe Non-hematological Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)|every month during treatment, up to 12 months||||participants|||Number
2784346|NCT00635024|Secondary|Duration of Response (DOR)|DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.|up to 2 years|All patients are non-evaluable - no patients responded to treatment.||||||
2784347|NCT00635024|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|up to 2 years||||months||95% Confidence Interval|Median
2784348|NCT00635024|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|up to 2 years||||months||95% Confidence Interval|Median
2784349|NCT00635024|Primary|Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 months|One participant was evaluable for the primary endpoint.|||participants|||Number
2784350|NCT00634933|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||percentage of participants|||Number
2784351|NCT00634933|Secondary|Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score|WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784352|NCT00634933|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784353|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784354|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784380|NCT00634920|Secondary|Time to Treatment Failure|Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Days||Standard Error|Mean
2784356|NCT00634933|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
2784357|NCT00634933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
2784358|NCT00634933|Secondary|General Health Visual Analog Scale (VAS)|"100 mm line (VAS) marked by participant. Participants were asked, How do you feel concerning your arthritis? Total possible score range, 0 mm = very well to 100 mm = extremely bad."|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784359|NCT00634933|Secondary|Patient Global Assessment (PtGA) of Disease Activity|Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
2784360|NCT00634933|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||units on a scale||Standard Deviation|Mean
2784361|NCT00634933|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||mm||Standard Deviation|Mean
2784362|NCT00634933|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.||||||
2784363|NCT00634933|Secondary|Number of Swollen Joints|The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||swollen joints||Standard Deviation|Mean
2784364|NCT00634933|Secondary|Number of Tender Joints|The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||tender joints||Standard Deviation|Mean
2784365|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||percentage of participants|||Number
2784366|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.|||percentage of participants|||Number
2784367|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.|||percentage of participants|||Number
2784368|NCT00634933|Primary|Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all randomized participants who received any portion of test article. Last observation carried forward (LOCF) method was used to impute missing values.|||percentage of participants|||Number
2784369|NCT00634920|Secondary|Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D|Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status.|Before randomization, Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||scores on a scale||Standard Deviation|Mean
2784370|NCT00634920|Secondary|Percentage of Participants Who Had Donor Specific Antibodies (DSA)|Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784371|NCT00634920|Secondary|Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))|"Proteinuria is when a large amount of protein, that should remain circulating in a person's blood, is spilled into their urine and eliminated from the body."|Months 12, 24, 36|The safety population (SAF) consists of all patients in whom TX was performed and who were randomized and treated with at least one dose of randomized treatment.|||mg/mmol||Standard Deviation|Mean
2784372|NCT00634920|Secondary|Percentage of Participants on Antihypertensive Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784373|NCT00634920|Secondary|Number of Antihypertensive Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Number of antihypertensive dugs||Standard Deviation|Mean
2784374|NCT00634920|Secondary|Percentage of Participants on Lipid-lowering Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784375|NCT00634920|Secondary|Number of Lipid-lowering Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Number of lipid-lowering drugs||Standard Deviation|Mean
2784376|NCT00634920|Secondary|Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides|Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mmol/L||Standard Deviation|Mean
2784377|NCT00634920|Secondary|Lipid Profile for Apolipoprotein|Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||g/L||Standard Deviation|Mean
2784378|NCT00634920|Secondary|Time to First Malignancy|This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Months||Standard Error|Mean
2784379|NCT00634920|Secondary|Percentage of Participants With Treatment Failures|Treatment failure was defined as graft loss or death.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784381|NCT00634920|Secondary|Percentage of Participants With Graft Loss or Death|The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event).|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784382|NCT00634920|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)|A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784383|NCT00634920|Secondary|Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)|Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space)|Month 12, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||Percentage of participants|||Number
2784384|NCT00634920|Secondary|Progression of Measured Glomerular Filtration Rate|Change in renal progression measured by mean mGFR from week 7 to Month 36|Week 7, Week 52, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mL/min/1.73m^2||Standard Deviation|Mean
2784385|NCT00634920|Secondary|Calculated Glomerular Filtration Rate|The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points.|Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mL/min/1.73m^2||Standard Deviation|Mean
2784386|NCT00634920|Secondary|Measured Glomerular Filtration Rate|Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis.|||mL/min/1.73m^2||Standard Deviation|Mean
2784387|NCT00634920|Primary|Measured Glomerular Filtration Rate|To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 12|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).|||mL/min/1.73m^2||Standard Deviation|Mean
2784388|NCT00634907|Post-Hoc|Mean Number of Doses Before the First Supratherapeutic INR|The number of warfarin doses administered before a patient INR exceeded the therapeutic range (>2.9) was recorded. The average was then calculated and is shown here.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses administered||Standard Deviation|Mean
2784389|NCT00634907|Post-Hoc|Mean Number of Doses Required for the First Therapeutic INR|The number of doses required to achieve a therapeutic INR (1.8-2.9) was determined per patient, per arm. The average was then calculated and is shown here.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses||Standard Deviation|Mean
2784390|NCT00634907|Post-Hoc|Percent of Patients With Dose Adjustments|The percent of patients that required a dose adjustment during the study period was calculated.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||percentage of patients|||Number
2784391|NCT00634907|Post-Hoc|Mean Number of Dose Adjustments|The average number of dose adjustments made per patient, per arm, during the study period was calculated|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses||Standard Deviation|Mean
2784392|NCT00634907|Post-Hoc|Mean Number of Doses Before First Dose Adjustment|The number of consistent doses administered before the first dose adjustment was required was recorded, per patient. The average number of doses administered before the first dose adjustment is shown.|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)||||doses||Standard Deviation|Mean
2784393|NCT00634907|Secondary|Percentage of Determinations Supratherapeutic (INR>2.9)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was greater than 2.9, the patient was considered to be supratherapeutic. The proportion of INR determinations that were supratherapeutic was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm|||percentage of determinations|||Number
2784424|NCT00634504|Primary|Pharmacokinetics (PK) of Leucovorin|Geometric mean 6S-leucovorin area under the curve|3 hours post LV administration||||micromol x hour/L||95% Confidence Interval|Geometric Mean
2784425|NCT00634322|Primary|Patients Progressing to Next Chemotherapy Cycle||1 week after intervention|||||||
2786479|NCT00619112|Secondary|Patients Progressing After Two First-line Adjuvant Courses of Temozolomide||After two first-line adjuvant courses of temozolomide||||Participants|||Count of Participants
2784394|NCT00634907|Secondary|Percentage of Determinations Subtherapeutic (INR<1.8)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was less than 1.8, the patient was considered to be subtherapeutic. The proportion of INR determination that were subtherapeutic was caluculated, per arm, based on the total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hop arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm|||percentage of deteminations|||Number
2784395|NCT00634907|Secondary|Percentage of Determinations in Therapuetic Range (INR 1.8-2.9)|"Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was between 1.8 and 2.9, the patient was considered to be therapeutic. The proportion of INR determinations that fell within the therapeutic range (INR between 1.8-2.9) was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin."|2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)|Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm|||percentage of therapeutic INR values|||Number
2784396|NCT00634907|Primary|The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement|"Adverse events were defined as~Major bleeding: fatal bleeding, bleeding into a critical organ, bleeding that requires hospital admission~Minor bleeding: clinically overt bleeding not meeting criteria for major bleeding~Symptomatic deep vein thrombosis (DVT)~Pulmonary embolism (PE)"|90 days post surgery||||participants|||Number
2784397|NCT00634842|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|"Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:~If subject was unable to treat himself: Major incidence.~If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.~If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only."|weeks 0-20|The safety population consists of all subjects exposed to study drug.|||number of events|||Number
2784398|NCT00634842|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline|Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20|week -2, week 20|The intent-to-treat (ITT), LOCF (last observation carried forward) population. One Subject in 70-90 group, however, had a missing baseline value, therefore, no change from baseline could be calculated.|||percentage point change||Standard Error|Least Squares Mean
2784399|NCT00634842|Secondary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%|Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)|||percentage of participants|||Number
2784400|NCT00634842|Primary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%|Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)|||percentage of participants|||Number
2784401|NCT00634751|Secondary|Overall Survival|Overall survival, defined as number of days from the day of first study drug administration to the day the patient dies, summarized using point estimates of the median time to progression, and associated 95% confidence intervals|Up to 18 months|Overall survival was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.|||Months||95% Confidence Interval|Median
2784402|NCT00634751|Secondary|Progression-free Survival (PFS)|Time to progression, defined as number of days from day of first study drug administration to the day the patient experiences an event of disease progression or death; summarized using point estimates of the median time to progression and associated 95% confidence intervals for each stratum separately.|Up to 18 months|PFS was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.|||Months||95% Confidence Interval|Median
2784403|NCT00634751|Primary|Overall Response Rate|Response rate of participant to treatment|Up to 18 months||||participants|||Number
2784404|NCT00634647|Secondary|Median Overall Survival (OS)|Overall Survival is the time between the first day of treatment to the day of death.|time between the first day of treatment to the day of death, approximately 15.7 months|24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).|||Months||95% Confidence Interval|Median
2784405|NCT00634647|Secondary|Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 57 months.|The time frame for adverse events includes one year follow-up data.|||Participants|||Count of Participants
2784406|NCT00634647|Primary|Progression Free Survival.|Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|15 months|24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).|||Months||95% Confidence Interval|Median
2787003|NCT00615069|Secondary|Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications||Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)||||Participants|||Number
2784407|NCT00634621|Secondary|Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.|The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.|Day 0 (Post contrast administration)|The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique.|||Percentage of confirmed Lesions||95% Confidence Interval|Number
2784408|NCT00634621|Primary|Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.|Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.|Day 0 (Post contrast administration)|Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC).|||Number of lesions|||Number
2784409|NCT00634582|Primary|Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer||16 weeks|This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.||||||
2784410|NCT00634569|Secondary|Number of Adverse Events|Total Number of Adverse Events|12 months||||All Adverse Events|||Number
2784411|NCT00634569|Secondary|Number of Days on Antibiotics (Prophylactic and Therapeutic).|Median Combined number of days on prophylactic and therapeutic antibiotics|12 months||||Days||Standard Deviation|Median
2784412|NCT00634569|Secondary|Number of Infectious Episodes Per Year|Mean Number of infectious episodes per subject/year|12 months||||Infectious episodes||Standard Deviation|Mean
2784413|NCT00634569|Secondary|Other Infections Documented by Fever and Physical Exam or Positive Radiograph.||12 months||||Number of other infections||Standard Deviation|Mean
2784414|NCT00634569|Secondary|Number of Visits to Physician/ER Room for Acute Problems|Mean Number of visits to physician/ER room for acute problems|12 months||||Visits||Standard Deviation|Mean
2784415|NCT00634569|Secondary|Days of Hospitalization Per Year|Mean Days of hospitalization per subject/year|12 months||||Days||Standard Deviation|Mean
2784416|NCT00634569|Secondary|Days of School/Usual Activities Missed Per Year|Mean Days of school/usual activities missed per subject/year|12 months||||Days||Standard Deviation|Mean
2784417|NCT00634569|Primary|Serious Bacterial Infections.|Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis|12 months||||Total serious bacterial infections|||Number
2784418|NCT00634543|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 43|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for at given time point.|||Units on a scale||Standard Deviation|Mean
2784419|NCT00634543|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43|The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for this outcome measure at a particular time point.|||Units on a scale||Standard Deviation|Mean
2784420|NCT00634543|Secondary|Overall Assessment of Study Medication by Investigator|Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.|||Percentage of participants|||Number
2784421|NCT00634543|Secondary|Overall Assessment of Study Medication by Participants|Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.|||Percentage of participants|||Number
2784422|NCT00634543|Secondary|Percentage of Participants With Pain Relief|Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved.|Day 15, Day 29 and Day 43|FAS included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.|||Percentage of Participants|||Number
2784423|NCT00634543|Primary|Change From Baseline in Pain Intensity Score at Day 43|Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.|Baseline and Day 43|Full analysis set (FAS) included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2784426|NCT00634283|Primary|Changes in Quantitative Electroencephalogram (qEEG) Prefrontal Cordance (PFC) Over 1 Week Placebo lead-in.|"Cordance values were calculated from conventional 'absolute' and 'relative' qEEG power measures using a three-step procedure. First, EEG power values were computed using a re-attributional electrode montage. Second, the absolute and relative power values were z-transformed to measure deviation from the mean values for each electrode site s in each frequency band f for that recording, yielding Anorm(s,f) and Rnorm(s,f), respectively. Third, these z-scores were summed to yield a cordance intensity value, Z, for each electrode in each frequency band where Z(s,f) = Anorm(s,f) + Rnorm(s,f). Analyses for this report focused on changes-from-baseline theta-band (8-12Hz) cordance in the prefrontal region (electrodes Fp1, Fpz, Fp2). Results are defined in terms of positive and negative change where a positive change represents an increased physiologic and behavioral response to the drug (sensitization) and a negative change represents an increased tolerance to the drug (habituation)."|1-week placebo lead-in||||Z-score||Standard Deviation|Mean
2784427|NCT00634283|Primary|Changes in Quantitative Electroencephalogram (qEEG) Prefrontal Cordance (PFC) Over Time (4 Weeks).|"Cordance values were calculated from conventional 'absolute' and 'relative' qEEG power measures using a three-step procedure. First, EEG power values were computed using a re-attributional electrode montage. Second, the absolute and relative power values were z-transformed to measure deviation from the mean values for each electrode site s in each frequency band f for that recording, yielding Anorm(s,f) and Rnorm(s,f), respectively. Third, these z-scores were summed to yield a cordance intensity value, Z, for each electrode in each frequency band where Z(s,f) = Anorm(s,f) + Rnorm(s,f). Analyses for this report focused on changes-from-baseline theta-band (8-12Hz) cordance in the prefrontal region (electrodes Fp1, Fpz, Fp2). Results are defined in terms of positive and negative change where a positive change represents an increased physiologic and behavioral response to the drug (sensitization) and a negative change represents an increased tolerance to the drug (habituation)."|Average over 4 weeks|Antidepressant-experienced subjects; n=2 and antidepressant-naive subjects; n=4|||z-score||Standard Deviation|Mean
2784428|NCT00634270|Secondary|To Evaluate the Role of Apolipoprotein E Genotypes as Predictors for Development of Hyperlipidemia During Therapy With Sirolimus.|Number of patients who experienced hyperlipidemia is being reported.|24 weeks Stratum 1 / 48 weeks Stratum 2||||participants|||Number
2784429|NCT00634270|Secondary|To Evaluate Pharmacogenetic Polymorphisms of Cytochrome P450 3A4 & 3A5 Alleles and P-glycoprotein/MDR for Their Influence on the Metabolism of Sirolimus in This Patient Population.|Trough concentration of sirolimus is reported in nanograms per mL.|24 weeks Stratum 1 Only|Subjects in Stratum 1.|||ng/mL||Standard Deviation|Mean
2784430|NCT00634270|Secondary|To Evaluate the Effect of Sirolimus on Clinical Response by Reduction in Pain, or Improvement in Function or Performance Scale.|There were no data collected for this outcome measure.|24 weeks Stratum 1 / 48 weeks Stratum 2|||||||
2784431|NCT00634270|Secondary|To Asses Preliminary Correlations of Radiographic Response With Changes in Pharmacodynamics Parameters Including p70s6 Kinase Activity in Peripheral Blood Mononuclear Cells.|Response by Volumetric MRI.|24 weeks Stratum 1 / 48 weeks Stratum 2|Samples were inadequate in quantity to allow for this analysis.||||||
2784432|NCT00634270|Secondary|To Assess the Value of Three-dimensional MRI (3-D MRI) in the Evaluation of Plexiform Neurofibromas and Paraspinal Neurofibromas, and to Compare 3-D MRI to Conventional Two-dimensional MRI (2-D MRI) and One Dimensional MRI (1-D MRI) Data Analysis|The study provided central review of all MRIs using a three-dimensional volumetric protocol. As the STOPN protocol began, research had already demonstrated the superiority of this approach to 1-D or 2-D analyses, so these were not used in the STOPN study.|24 weeks Stratum 1 / 48 weeks Stratum 2|The data for this outcome wasn't collected because prior to the study, it was determined that MRI (3-D MRI) was already superior, so the MRI was not performed on any of the participants||||||
2784433|NCT00634270|Secondary|To Evaluate the Quality of Life During Treatment With Sirolimus by Assessing Preliminary Correlations of Response With Quality-of-life Outcomes|Self-reported, age-appropriate PedsQL Scale. Assessments included: Inventory for physical function, emotional function, social function and school function - number system 0-4 was used with 4 being the worse maximum threshold); inventory for chronic illness used a 5-point likert scale - 5 being the worst maximum threshold; Skindex-Teen used a scale of 0 to 100 - the higher the number the more frequent the experience; Pain intensity was measured using a line with a happy and sad face - marks toward the sad face indicated more intense pain; and, the McGill Pain Questionnaire - higher values indicating worse pain of a scale from 0-3. All assessments were combined for an overall PedsQL score by rating each item 0-4, then reverse transforming each to a 0 - 100 scale. The total scores were calculated by averaging the item scores, with higher scores being better.|24 weeks Stratum 1 / 48 weeks Stratum 2|Stratum 1 patients with Neurofibromatosis Type 1; all ages - Change from Baseline to Course 3. Stratum 2 did not meet the requirements for response at the 6 month time point. Therefore, Stratum 2 was not analyzed for this aim.|||Units on a scale||Standard Deviation|Mean
2784434|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - Therapeutic Dose (mg/kg)^0.75|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (ages 3 to 18) - Therapeutic Dose (mg/kg)^0.75. Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Therapeutic Dose (mg/kg)^0.75||Standard Deviation|Mean
2784435|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus in When Administered to This Patient Population - Therapeutic Dose (mg/kg Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (Ages 3 to 18) Therapeutic Dose (mg/kg per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Therapeutic Dose (mg/kg per dose)||Standard Deviation|Mean
2784436|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population- Therapeutic Dose (mg/m^2 Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients - Therapeutic Dose (mg/m^2 per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Therapeutic Dose mg/m^2 per dose||Standard Deviation|Mean
2784437|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - (Clearance (L/h Per 1.85 m^2)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 Patients Clearance (L/h per 1.85 m^2). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||L/h per 1.85 m^2||Standard Deviation|Mean
2784438|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population Using Liters/Hour Per Population Median Weight of 70kg (L/h70kg)|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1 used allometrically scaled clearance (clearance scaled to a 70kg individual). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||L/h/70kg||Standard Deviation|Mean
2784439|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus Administered to This Patient Population (Clearance Liters/Hour (L/h))|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Pediatric Patients (3 through 18) with Neurofibromatosis Type 1 - Clearance liters/hour (L/h). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.|||Clearance liters/hour (L/h)||Standard Deviation|Mean
2784440|NCT00634270|Primary|Toxicity|Number of participants experiencing adverse events|24 weeks Stratum 1 / 48 weeks Stratum 2|All evaluable participants for Stratum 1 and 2 combined.|||Participants|||Number
2784441|NCT00634270|Primary|Results in Objective Radiographic Responses Based on Volumetric MRI Measurements in Children and Adults With NF1 and Inoperable PN in the Absence of Documented Radiographic Progression at Trial Entry|Stratum 2 outcome - Response|48 weeks Stratum 2|Identify the index plexiform neurofibroma(s) for 3-D MRI evaluation based on prior imaging studies. The criteria for response was <20% increase in volume using RECIST v1.0. Response for 48 weeks was only assessed for Stratum 2.|||participants|||Number
2784442|NCT00634270|Primary|Time to Disease Progression Based on Volumetric MRI|Median time to progression in Stratum 1 as defined as an increase of at least 20% of the volume of the primary lesion. Note: Since Stratum 2 looked at response rate only, median time to progression was not reviewed for this outcome.|24 Months Stratum 1|"All evaluable participants. Note: In Stratum 2 the value was not assessed as time to progression therefore the appropriate response would be N/A. Stratum 2 was reported as response rate only."|||Months||95% Confidence Interval|Median
2784443|NCT00634244|Secondary|The Rate of Treatment Failure|"The definition of treatment failure will include:~≥ 5% leukemic blasts at the time of pre-consolidation marrow~Death during/following induction chemotherapy (pre-consolidation)~Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy~CNS or extramedullary disease at the time of pre-consolidation~Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy"|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated|||proportion of participants||90% Confidence Interval|Number
2784444|NCT00634244|Primary|The Rate of Complete Remission (CR+CRi)|CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L).|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated|||proportion of participants||90% Confidence Interval|Number
2784445|NCT00634179|Secondary|An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria|Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.|Following completion of therapy, up to 2 years||||participants|||Number
2784446|NCT00634179|Primary|Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.|Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks||||mg/m^2||95% Confidence Interval|Number
2784447|NCT00634166|Secondary|The Secondary Objective is to Examine the Reasons for Graft Loss in Subjects Treated With Sulfamylon® Solution Versus Historical Controls.||Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 and Days 18-21; Treatment Failure at Days 5-7; and Infectious Graft Loss at Days 5-7, Days 12-14 and Days 18-21.|||||||
2784448|NCT00634166|Primary|Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.||The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.||||Percentage of Participants|||Number
2784449|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.|Up to 12 weeks||||Participants|||Number
2784450|NCT00634114|Primary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.|Up to 24 weeks||||Participants|||Number
2784451|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.|up to 4 weeks||||Participants|||Number
2784452|NCT00634088|Secondary|Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib|Duration of response is measured from the time in months that measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented PD or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.|First occurrence of PR or CR to PD or Death (no average, as no data available)|Because the study was terminated due to insufficient enrollment, the duration of response could not be analyzed.||||||
2784453|NCT00634088|Secondary|Overall Tumor Response By Number of Participants|Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|Baseline and Day 21 (21-day cycle)|All participants with measurable disease at baseline per RECIST guidelines, with the exception of those with an incorrect diagnosis.|||Participants|||Number
2784454|NCT00634088|Primary|MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine|MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, no participants received the triplet combination.||||||
2784455|NCT00634088|Secondary|Volume of Distribution at Steady State of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||Liters||Standard Deviation|Mean
2784456|NCT00634088|Secondary|Time to Peak Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||Hours||Full Range|Median
2784457|NCT00634088|Secondary|Terminal Half-life of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||Hours||Standard Deviation|Mean
2784458|NCT00634088|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||ng*h/mL||Standard Deviation|Geometric Mean
2784459|NCT00634088|Secondary|Maximum Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.|||ng/mL||Standard Deviation|Geometric Mean
2784460|NCT00634088|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN-2.5*ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN-2.5* ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN-2.5*ULN, Gr 2:>2.5-5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-10.0*ULN, Gr 4:>10.0*ULN|At baseline and within 72 hours of Day 1 of 21-day cycle|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
2784461|NCT00634088|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC (c/uL): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count (c/uL): Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0*10^9/L; Hemoglobin (g/dL): Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|Baseline and weekly from Days 1 to 21 (Cycle 1)|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
2784462|NCT00634088|Secondary|Number of Participants With DLT|DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
2784475|NCT00634036|Secondary|Juniper Asthma Control Questionnaire|The Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control. Values > 1.5 are compatible with poorly controlled asthma|12 weeks||||Scores on a scale||Standard Deviation|Mean
2784476|NCT00634036|Secondary|FEV1 % Predicted||12 weeks||||% predicted||Standard Deviation|Mean
2784477|NCT00634036|Primary|Airway Reactivity|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by > 20% from pre-methacholine baseline values.|12 weeks||||mg/ml||Inter-Quartile Range|Median
2784463|NCT00634088|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)|AE=Any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, important, a congenital anomaly/birth defect; or requires or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Common Terminology Criteria (CTC) Grade 3=severe; Grade 4=life-threatening or disabling.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.|||Participants|||Number
2784464|NCT00634088|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib|The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, MTD was not achieved.||||||
2784465|NCT00634049|Secondary|Safety - Overall Number of TEAEs|A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.|From the first study drug administration until 28 days after the last dose of study drug|The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study|||participants|||Number
2784466|NCT00634049|Secondary|All-cause Mortality Through Day 42 and Day 84|"All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Baseline to End of Treatment (EOT [Day 180])|Intent-To-Treat population (ITT)|||percentage of participants|||Number
2784467|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784468|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784469|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784470|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784471|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784472|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784473|NCT00634049|Primary|Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).|"The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)|||percentage of participants|||Number
2784474|NCT00634036|Secondary|Exhaled Nitric Oxide Ppb||12 weeks||||ppb||Standard Deviation|Mean
2784478|NCT00634010|Primary|Participant Pain Severity Score Measured Using Brief Pain Inventory|"Brief Pain Inventory (BPI): Pain severity measured with BPI, which asks participants to rate pain for last 24 hours on 0 to 10 scales at its worst, least, average  and now. The scales are presented on a 10 cm line, with each number equidistant from the next. Each scale is bounded by the words no pain' at the 0 end and pain as bad as you can imagine at the other. BPI used to determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 4 week (+/- 3 days) treatment period in participants with advanced cancer."|Comparing baseline and pain scores at 4 weeks (+/- 3 days)|The study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups. Participants eligible for the study often had significant symptom distress and could not continue in the four week study period needed for data collection contribution to mean calculation.||||||
2784479|NCT00633984|Primary|CGI - Clinical Global Impression of Improvement|"The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 (very much improved) to 7 (very much worse). Response and remission was defined as an improvement score of 1 (very much improved) or 2 (much improved) on the CGI-I."|Week 13||||units on a scale||95% Confidence Interval|Mean
2784480|NCT00633984|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale|Week 13||||units on a scale||95% Confidence Interval|Mean
2784481|NCT00633945|Secondary|Skindex Function|"Skindex function scores are scored 1-5 and then normalized to 100, with a higher score corresponding to a worse impression. The absence of function impact on QoL is scored as 20 (this is represented as a 1 on the 1-5 scale. The worst impact of function on QoL is 100. This is represented as a 5 on the 1-5 scale."|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784482|NCT00633945|Secondary|Skindex Symptoms|"Skindex symptoms scores are scored 1-5 and then normalized to 100, with a higher score corresponding to a worse impression. The absence of symptom impact on QoL is scored as 20 (this is represented as a 1 on the 1-5 scale. The worst impact of symptoms on QoL is 100. This is represented as a 5 on the 1-5 scale."|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784483|NCT00633945|Secondary|Fatigue|Fatigue scores were recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no fatigure and 10 to fatigue as bad as you can imagine.|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784484|NCT00633945|Secondary|Itch in Skin|Itch scores were recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no itch and 10 to itch as bad as you can imagine.|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784485|NCT00633945|Secondary|Pain in Skin|Pain in skin was recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no pain and 10 to pain as bad as you can imagine.|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784486|NCT00633945|Secondary|Patient General Assessment (PtGA) for Skin|General skin scores were recorded by the patient on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to worst skin condition imaginable and 10 to perfect health.|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784487|NCT00633945|Secondary|Physician Global Assessment (PGA) for Skin|General skin scores were recorded on a 10 cm visual analogue scale at each visit. At each visit on scale 0-10, 0 corresponding to worst skin condition imaginable and 10 to perfect health.|Weeks 0 through 52|5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.|||units on a scale||Full Range|Mean
2784488|NCT00633945|Secondary|Number of Participants With Change in IFN and CD4 Levels at 6 Weeks|CXCL10, an interferon-inducible chemokine, and immunophenotyping by immunostaining. Measurement of interferon-inducible genes from peripheral blood mononuclear cells before and after treatment.|6 weeks||||Participants|||Count of Participants
2784489|NCT00633945|Primary|Cutaneous Lupus Area and Severity Index (CLASI)|The Cutaneous Lupus Area and Severity Index (CLASI); range of disease activity is 0-70. Lower scores reflect less activity|Weeks 0 through 52|Two patients were not included at week 52 because one did not respond and one had new onset proteinuria and arthralgias.|||units on a scale||Full Range|Mean
2784490|NCT00633932|Secondary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification"|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|4 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.|||participants|||Number
2784596|NCT00633074|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2784491|NCT00633932|Primary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification."|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|8 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.|||participants|||Number
2784492|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007|"The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2007: All available data were used to their full extent, but no imputation of data was performed.|||Participants|||Number
2784493|NCT00633919|Secondary|Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008|"The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.|||Participants|||Number
2784494|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008|"The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.|||Participants|||Number
2784495|NCT00633919|Secondary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2007. All available data were used to their full extent, but no imputation of data was performed.|||Scores on a scale||Standard Deviation|Mean
2784496|NCT00633919|Primary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2008. All available data were used to their full extent, but no imputation of data was performed.|||Scores on a scale||Standard Deviation|Mean
2784497|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 7, 4, 14 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784522|NCT00633880|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|One placebo patient excluded from analysis because OHDAS values were not evaluable.|||units on a scale||Standard Deviation|Mean
2784498|NCT00633893|Secondary|Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 10 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784499|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 7 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784500|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 8, 4, 15 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784501|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 6, 8, 53 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2784502|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 76 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2784520|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)|OHSA composite scale (items 2-6) is the average of five OHSA items: 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|"One placebo patient excluded from analysis per the SAP because all baseline values in the composite were zero.~LOCF was used to impute values for patients who did not have an end of study visit."|||units on a scale||Standard Deviation|Mean
2787004|NCT00615069|Primary|Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year||Treatment through 1 year post-procedure (365 days)||||days||Standard Error|Mean
2784503|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 73 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||proportion of participants||95% Confidence Interval|Number
2784504|NCT00633893|Secondary|Adjudicated Total Bleeding During the Treatment Period - Treated Participants|All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 94, 121, 74 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784505|NCT00633893|Secondary|Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants|All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 75, 98, 58 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784506|NCT00633893|Secondary|Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 25, 34, 19 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784507|NCT00633893|Secondary|Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated participants were those who received at least 1 dose of study drug. (n)number of events = 27, 35, 22 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.|||proportion of participants||95% Confidence Interval|Number
2784508|NCT00633893|Secondary|Adjudicated Major Bleeding During the Treatment Period - Treated Population|Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 2, 1, 4 in apixaban 2.5 mg, and 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784523|NCT00633880|Secondary|Change in Head/Neck Discomfort (OHSA Item 6)|OHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
2784509|NCT00633893|Secondary|Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation|All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. In first event (first primary event) each participant counted once. In event category, each participant was counted only once in each event category but could have been counted in multiple categories.|||participants|||Number
2784510|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. (n) number of events = 22, 25, 33 in apixaban 2.5 mg, apixaban 5 mg, and placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784511|NCT00633893|Secondary|Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. number of events (n)= 17, 24, 29 in the apixaban 2.5 mg, 5 mg, placebo arms, respectively.|||Proportion of Participants||95% Confidence Interval|Number
2784512|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 17, 24, 26 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784513|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 23, 25, 37 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784521|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)|The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
2784574|NCT00633243|Primary|Number of Participants With a Sustained Virologic Response (SVR)|SVR is defined as continued undetectable HCV viral load at 24 weeks|24 weeks (end of treatment)|All subjects in mDOT arm and SAT arm who completed treatment.|||participants|||Number
2784514|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 19, 28, 72 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.|||Proportion of participants||95% Confidence Interval|Number
2784515|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent.(n)number of events=27, 34, 95 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. The (n)number of imputed events were = 13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits|||proportion of participants||95% Confidence Interval|Number
2784516|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned.(n)number of events = 19, 14, 77 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. All events were counted; no events were imputed.|||Proportion of participants||95% Confidence Interval|Number
2784517|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|ITT: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=27, 34, 92 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. Number of imputed events=13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784518|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=32, 34, 96 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively; number of events imputed=13, 20, 19, respectively. Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits.|||Proportion of participants||95% Confidence Interval|Number
2784519|NCT00633880|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing;|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|three placebo patients excluded from the analysis due to missing standing blood pressure values at either randomization or end of study.|||mmHg||Standard Deviation|Mean
2784959|NCT00630487|Secondary|Change From Baseline in Cardiovascular Risk Factors|Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)|Baseline, Week 52, Week 78|||||||
2784524|NCT00633880|Post-Hoc|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) ."|14 days|3 droxidopa patients and 2 placebo patients were excluded from the analysis due to missing randomization values.|||units on a scale||Standard Deviation|Mean
2784525|NCT00633880|Secondary|Change in Concentration (OHSA Item 5)|OHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
2784526|NCT00633880|Secondary|Change in Vision (OHSA Item 2)|OHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
2784527|NCT00633880|Secondary|Change in Weakness (OHSA Item 3)|OHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
2784528|NCT00633880|Secondary|Change in Fatigue (OHSA Item 4)|OHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days||||units on a scale||Standard Deviation|Mean
2784529|NCT00633880|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|Missing data were imputed using the last observation carry forward method.|||units on a scale||Standard Deviation|Mean
2784530|NCT00633867|Primary|Intubation Time|Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation|At intubation||||seconds||Inter-Quartile Range|Median
2784531|NCT00633867|Secondary|Incidence of Visible Trauma to the Airway||At analysis|||||||
2784532|NCT00633867|Secondary|Incidence of Low Arterial Saturation During Intubation||At analysis|||||||
2784533|NCT00633867|Secondary|Number of Intubations Taking More Than 70 Seconds||At Analysis|||||||
2784534|NCT00633867|Secondary|Incidence of Initial Oesophageal Intubation||At analysis|||||||
2784535|NCT00633867|Secondary|Number of Attempts to Secure Successful Intubation|Is there a difference in the number of attempts required to secure successful intubation ?|At analysis|||||||
2784536|NCT00633867|Secondary|Quality of View of the Vocal Cords||At analysis|||||||
2784537|NCT00633867|Secondary|Difference in Learning to Use the Scopes|Is there a difference between trainee anaesthetists in learning to use the scopes|At analysis|||||||
2784538|NCT00633750|Secondary|Average Post-treatment Plasma Level of Erlotinib Hydrochloride|Post-treatment plasma level in µmol/L of erlotinib hydrochloride|After last dose of Tarceva, at 5-14 days, and before surgery|Participants with blood taken within 24 hours of last dose of erlotinib and before surgery|||µmol/L||Standard Deviation|Mean
2784539|NCT00633750|Secondary|Molecular Profile of Participants Who Are Responsive to Tarceva|Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = > 10% of cell show staining, negative = < 10% of cells show staining|at 5-14 days|Participants with available pre- and post-treatment tissue and who demonstrated a post-treatment decrease in Ki67 levels compared to their pre-treatment levels|||participants|||Number
2784540|NCT00633750|Primary|Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva|In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.|5-14 days|Patients who received the study drug and who had available pre- and post-treatment tissue.|||participants|||Number
2784541|NCT00633594|Secondary|Overall Survival of Previously Treated and Previously Untreated Participants|"Defined as the date of study entry to the date of death.~Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment|||months||95% Confidence Interval|Median
2784542|NCT00633594|Secondary|Overall Survival of Phase I and Phase II Participants|"Defined as the date of study entry to the date of death.~Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment|||months||95% Confidence Interval|Median
2784597|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2784543|NCT00633594|Secondary|Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.~Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment|||months||95% Confidence Interval|Median
2784544|NCT00633594|Secondary|Progression Free Survival (PFS) of Phase I and Phase II Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.~Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment|||months||95% Confidence Interval|Median
2784545|NCT00633594|Secondary|Duration of Response (DoR) of Previously Treated and Previously Untreated Participants|Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)|||months||95% Confidence Interval|Median
2784546|NCT00633594|Secondary|Duration of Response (DoR) of Phase I and Phase II Participants|"Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.~Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)|||months||95% Confidence Interval|Median
2784547|NCT00633594|Secondary|Time to Best Response of Previously Treated and Previously Untreated Participants|Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All patients that received study treatment that were evaluable for a response assessment (2 previously untreated participants and 1 previously treated participant were considered unevaluable, discontinuing prior to first post-baseline response assessment)|||months||95% Confidence Interval|Median
2784548|NCT00633594|Secondary|Time to Best Response of Phase I and Phase II Participants|"Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.~Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All participants that received study treatment that were evaluable for a response assessment (one participant in Phase I and two participants in Phase II were considered unevaluable, discontinuing prior to first post-baseline response assessment)|||days||Full Range|Median
2784549|NCT00633594|Secondary|Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)|||Participants|||Count of Participants
2784575|NCT00633217|Secondary|Mean Change From Baseline in Peak Expiratory Flow|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. This is measured by a peak flow meter which is a hand held device. Change from baseline was calculated as the average value over Weeks 1-12 minus the baseline value.|Baseline through Week 12|ITT Population. Some participants did not have measured values for peak expiratory flow and were thus not included in the analysis.|||Liters/minute (L/min)||Standard Error|Mean
2784550|NCT00633594|Secondary|Overall Response Rate (ORR) of Phase I and Phase II Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)|||Participants|||Count of Participants
2784551|NCT00633594|Primary|Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II|"A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study.~Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6"|Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment|Includes patients that were enrolled in the Phase II section of the study|||participants|||Number
2784552|NCT00633594|Primary|Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants|"Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03.~MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab.~Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash)"|Collected from day of first dose to the end of the first treatment cycle, up to 21 days|Includes patients that were enrolled in both lenalidomide dose levels (10 mg PO daily, 15 mg PO daily) in the Phase I portion of the study|||mg lenalidomide, orally, daily, day 1-14|||Number
2784553|NCT00633477|Secondary|Ventilator Free Days.|Number days participant was not on Ventilattor support.|Day 28|This study was terminated early when 17 subjects had received treatment.|||Days|||Number
2784554|NCT00633477|Secondary|Vasopressor Free Days.|Number days participant did not need vasopressors.|Day 28|This study was terminated early when 17 subjects had received treatment.|||days|||Number
2784555|NCT00633477|Secondary|ICU Free Days|Number days participant was not in ICU|Day 28|This study was terminated early when 17 subjects had received treatment.|||days|||Number
2784556|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug|||Percent of Participant|||Number
2784557|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug.|||Participants|||Number
2784558|NCT00633464|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase: GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.|||participants|||Number
2784559|NCT00633464|Primary|Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST)|PD = At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.|Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months).|All randomized participants.|||participants|||Number
2784560|NCT00633464|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3:<8.0-6.5g/dL, GR4:<6.5g/dL. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3:<50.0-25.0*10^9/L, GR4:<25.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3:<1.0-0.5*10^9/L; GR4:<0.5*10^9/L. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3:<2.0-1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.|||participants|||Number
2784576|NCT00633217|Secondary|Mean Change From Baseline in AM Pre-dose FEV1|Change from baseline was calculated as the value at Endpoint minus the baseline value. AM pre-dose FEV1, which is assessed using spirometry, is the maximum amount of air you can forcefully exhale in one second prior to taking the morning dose of study drug. Endpoint was defined as the last scheduled observation for AM pre-dose FEV1 during the 12-week treatment period.|Measurement of FEV1 prior to study drug administration; Baseline through Week 12|ITT Population. The numbers analyzed do not match Baseline numbers due to missing data for some participants.|||mL||Standard Error|Mean
2784561|NCT00633464|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. Other reasons for death included hepatic failure and respiratory distress.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm)|All treated participants: Participants who received any treatment (ixabepilone or cetuximab).|||participants|||Number
2784562|NCT00633464|Secondary|Duration of Response|Defined as period from the time that measurement criteria are first met for CR or PR until first date of documented PD or death. Estimated using the Kaplan-Meier product-limit method; CI was computed using Brookmeyer and Crowley method. CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of LD of all target lesions with reference to baseline sum LD. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months)|Randomized participants with response of CR or PR. Participants who did not relapse or die were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
2784563|NCT00633464|Primary|Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])|The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2784564|NCT00633464|Secondary|Time to Response|"Time to response is defined as the time from the date of start of treatment until measurement criteria are first met for PR or CR (whichever is recorded first).~CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions with reference to the baseline sum LD.~Time to response was estimated using the Kaplan-Meier product-limit method."|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.)|Randomized participants with response of CR or PR.|||weeks||Full Range|Median
2784565|NCT00633464|Secondary|Progression Free Survival (PFS)|"PFS is defined as the time interval from date of randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.~PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall."|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months)|All randomized participants. Participants who did not progress or die were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
2784566|NCT00633399|Secondary|Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8|This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
2784567|NCT00633399|Secondary|Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.|A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2.|8 weeks||||Percentage of patients|||Number
2784568|NCT00633399|Primary|The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2|The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.|8 Weeks||||Percentage of patients|||Number
2784569|NCT00633360|Secondary|Percent Change in Daily Record of Severity of Problems (DRSP)|The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.|Baseline and 2 months||||percent change||Inter-Quartile Range|Median
2784570|NCT00633360|Primary|Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.|Baseline and 2 months||||percent change||Inter-Quartile Range|Median
2784571|NCT00633256|Secondary|Urinary Cotinine Level|Urinary Cotinine level at the 4-week follow up timepoint|4 Week Follow-up Timepoint|Subjects used for analysis are those who reached the 4 week followup timepoint.|||Mean ng/ml||Standard Deviation|Mean
2784572|NCT00633256|Secondary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 4-week follow up timepoint.|4 Week Followup|The number of subjects in the study at the 4-week timepoint.|||Cigarettes per day||Standard Deviation|Mean
2784573|NCT00633256|Primary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 1 week follow up time point.|1 week follow-up|The number of participants used for analysis were those who completed the 4-week follow-up timepoint.|||Cigarettes per day||Standard Deviation|Mean
2784577|NCT00633217|Primary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug|The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.|2 hours after administration of blinded study drug; Baseline through Week 12|Intent-to-Treat (ITT) Population: all participants who had been randomized to study drug. The numbers analyzed do not match Baseline numbers due to missing data for some participants.|||milliliters (mL)||Standard Error|Mean
2784578|NCT00633152|Secondary|The Safety of Ceftaroline Fosamil|Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)|First dose of study drug through LFU Visit or 30 days after the last dose of study drug|||||||
2784579|NCT00633152|Secondary|The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit|Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.|LFU Visit (21 to 35 days after end of therapy)|||||||
2784580|NCT00633152|Secondary|Clinical Relapse at the Late Follow-up Visit|Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.|Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)|||||||
2784581|NCT00633152|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations|Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.|TOC Visit (8 to 15 days after end of therapy)|||||||
2784582|NCT00633152|Secondary|The Microbiological Response at the TOC Visit in the mMITT and ME Populations.|Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.|TOC Visit (8 to 15 days after end of therapy)|||||||
2784583|NCT00633152|Secondary|Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.|Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.|End-of-therapy (EOT) visit|||||||
2784584|NCT00633152|Secondary|Clinical Cure Rate at the TOC Visit in the cMITT Population|Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.|TOC Visit (8 to 15 days after end of therapy)|||||||
2784585|NCT00633152|Primary|Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 Days after end of therapy)|The Clinically Evaluable (CE) Population included all subjects who satisfied key minimum protocol criteria|||percentage of participants||95% Confidence Interval|Number
2784586|NCT00633152|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 days after end of therapy)|Modified-Intent-to-Treat (MITT) Population - Any randomized subjects that received any amount of study drug|||percentage of participants||95% Confidence Interval|Number
2784587|NCT00633139|Secondary|Change in Cerebrospinal Fluid (CSF) Sulfatide|Changes in CSF sulfatide from baseline to end of study (Week 52). Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population|||%change in CSF sulfatide||95% Confidence Interval|Mean
2784588|NCT00633139|Primary|Relative Change in Mullen's Scales of Early Learning|Changes in Mullen's Scales of Early Learning are measured from baseline to end of study (Week 52) using Mullen's Scales of Early Learning. T scores, percentile ranks, and age equivalents can be computed for the four scales separately (visual reception, fine motor, expressive language, and receptive language). Relative change is calculated as percentage change from baseline divided by the age-difference in months between first and last visit. When Mullen's score decreases over time, it indicates the disease worsened over time. Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population.|||Relative % change in Mullen's SOT||95% Confidence Interval|Mean
2784589|NCT00633139|Primary|Relative Changes (%) in Gross Motor Function Measurement (GMFM)|Change (percent change) in GMFM is measured from baseline to end of study (Week 52). GMFM is measured using GMFM-88. The GMFM-88 item scores can be summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score is between 0 (minimal) to 3 (maximum). The total GMFM-88 score is between 0 (minimal) to 264 (maximum). Relative changes in GMFM are calculated as percentage change from baseline divided by the age difference in months between first and last visit. The GMFM score decreases over time, which, indicates that the disease worsened over time. Score over time (SOT), data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|Intent to Treat (ITT) population included all the participants in the study.|||Relative % change in total GMFM-88 SOT||95% Confidence Interval|Mean
2784590|NCT00633126|Secondary|Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).|"A TEAE is any untoward medical occurrence a subject experiences following study drug administration.~Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7."|Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).|"per protocol~Out of 9 participants analyzed, 1 subject did not receive the full dose of study drug."|||events|||Number
2784591|NCT00633126|Primary|The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.|The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.|12 hours after infusion|per protocol|||ng/mL||Standard Deviation|Mean
2784598|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2784599|NCT00633074|Secondary|Duration of Solicited General Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
2784600|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2784601|NCT00633074|Secondary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
2784602|NCT00633074|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2784603|NCT00633074|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains|A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2784604|NCT00633074|Secondary|HI Antibody Seroconversion Factors|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2784605|NCT00633074|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2784606|NCT00633074|Secondary|Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2784607|NCT00633074|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2784608|NCT00633061|Secondary|Bleeding Complications Associated With Enoxaparin Therapy, Need for Additional Platelets|Bleeding complications associated with enoxaparin therapy, need for additional platelets|6 weeks|Since no patient was enrolled on Arm B of this study, there is no analysis of bleeding.||||||
2784609|NCT00633061|Primary|Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia|catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia|16 weeks|No patient was enrolled on the randomized clinical trial (arm B) after being on the prospective screening trial (Arm A)||||||
2784610|NCT00633022|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Follow-up (Day 98)|Safety Population.|||Participants|||Count of Participants
2784792|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC|Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||pmol*h/L||Standard Error|Least Squares Mean
2784611|NCT00633022|Secondary|Number of Participants With Urinalysis Dipstick Results|A urine dipstick test is a basic diagnostic tool used to determine pathological changes in a participant's urine in standard urinalysis. Data was analyzed for urine occult blood, urine glucose, urine ketones and urine protein ranging from 2+, trace, 1+, 3+, 1+or 1/4, 3+ or 1 and trace or 1/10, indicating proportional concentrations in the urine sample. Data has been presented for categories with values for positive findings.|Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population.|||Participants|||Count of Participants
2784612|NCT00633022|Secondary|Number of Participants With Hematology Abnormalities of PCI|Hematology range for PCI was: white blood cell count (WBC) low < 1.1 x109/ L; hemoglobin low <71 (age: 18-99) grams per litre (g/L), high >199 (age: 18-99) g/L; hematocrit low 0.201 (age: 18-99) ratio of 1 high 0.599 (age: 18-99) ratio of 1 and platelet count low < 80 x109/ L, high > 500 x109/ L. Categories with values have been presented.|Up to Follow-up (Day 98)|Safety Population.|||Participants|||Count of Participants
2784613|NCT00633022|Secondary|Number of Participants With Clinical Chemistry Abnormalities of PCI|Clinical chemistry range for PCI was calcium low <1.5 mill mole per litre (mmol/L), high > 3.24 mmol/L; creatinine high 155 mmol/L; glucose low < 2.2 (age: 13-99) mmol/L, high > 27.8 (age: 13-99) mmol/L; phosphorus low < 2.8 mmol/L, high > 6.5 mmol/L; sodium low < 125 mmol/L, high > 150 mmol/L. Categories with values have been presented.|Up to Follow-up (Day 98)|Safety Population.|||Participants|||Count of Participants
2784614|NCT00633022|Secondary|Number of Participants With 12-lead Electrocardiogram (ECG) Findings|All 12-lead ECGs were obtained after the participant had rested in the supine position for at least 15 minutes. All ECGs were evaluated by the principal investigator or designee for any other abnormality of potential clinical importance (PCI). Data for abnormal ECG findings have been reported under abnormal - Not clinically significant (NCS) and Abnormal - Clinically significant (CS) categories. Data only for categories with values have been presented.|Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2784615|NCT00633022|Secondary|Mean Heart Rate at Indicated Time Points|Vital sign monitoring included heart rate measurement. Heart rate measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).|Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population. Only those participants with data available at the specified time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
2784616|NCT00633022|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|Blood pressure measurements were taken to observe vital signs and included SBP and DBP. SBP and DBP measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).|Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98|Safety Population comprised of all participants who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.|||millimeter of mercury (mm/Hg)||Standard Deviation|Mean
2784617|NCT00633022|Secondary|Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)|CRP is a protein that the liver makes when there is inflammation in the body. It's also called a marker of inflammation, and can be measured with an hs-CRP test. Blood samples were collected to analyze hs-CRP. Baseline was defined as the value on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.|Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84|PD Population. Only those participants with data available at the specified time points were analyzed.|||milligram per litre (mg/L)||Standard Deviation|Mean
2784618|NCT00633022|Secondary|Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy|Most diseased segment (MDS) mean of max TBR was mean of all the slice max TBR that compose the most diseased segment. TBR was derived by dividing the arterial vessel wall SUV (tissue) by the background venous blood pool SUV. Unless noted otherwise, the tissue max SUV value for each ROI was used as inputs to the TBR. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.|Baseline (Days -14 to -1) and up to Week 12|PD Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
2784619|NCT00633022|Primary|Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy|Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.|Baseline (Days -14 to -1) and up to Week 12|Pharmacodynamic (PD) Population comprised of all participants who provided PD data. Only those participants with data available at the indicated time points were analyzed.|||Maximum tissue to background ratio||Standard Deviation|Mean
2784620|NCT00633009|Secondary|The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites|Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.|74 days||||No. of participants with reactions|||Number
2784621|NCT00633009|Primary|Sensitizing Effects of LtSTA in Leishmania Naive Adults|Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.|62 days|Number of participants completed.|||participants|||Number
2784622|NCT00632970|Secondary|Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.||24 weeks|Data can not be reported because the samples were never analyzed and therefore no data was analyzed.||||||
2784623|NCT00632970|Primary|Absolute Change in CD4 Cell Counts||24 and 48 weeks||||cells/mm^3||Full Range|Mean
2802450|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|2 Weeks|Data available at 2-week follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2784624|NCT00632931|Primary|Change From Baseline in QTcF at 24 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 24 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784625|NCT00632931|Primary|Change From Baseline in QTcF at 12 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 12 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784626|NCT00632931|Primary|Change From Baseline in QTcF at 8 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 8 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784627|NCT00632931|Primary|Change From Baseline in QTcF at 4 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.|Baseline and 4 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784628|NCT00632931|Primary|Change From Baseline in QTcF at 3 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 3 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784629|NCT00632931|Primary|Change From Baseline in QTcF at 2 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 2 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784630|NCT00632931|Primary|Change From Baseline in QTcF at 1 Hour|Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 1 hour|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784631|NCT00632931|Primary|Change From Baseline in QTcF at 0.5 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 0.5 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"|||milliseconds||95% Confidence Interval|Mean
2784632|NCT00632827|Secondary|Median Time to Response|The time to response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) in months.|Up to 2 years||||months||Full Range|Median
2784633|NCT00632827|Secondary|Complete Response Rate|The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients.|Up to 3 years||||Participants|||Count of Participants
2784634|NCT00632827|Secondary|Overall Survival Rate|Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial.|Up to 5 years||||percentage of participants|||Number
2784793|NCT00631488|Secondary|Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg.h/dL||Standard Error|Least Squares Mean
2784635|NCT00632827|Primary|Progression Free Survival|Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy|Up to 3 years||||percentage of partcipants|||Number
2784636|NCT00632814|Secondary|Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.|||Scores on a scale||Standard Deviation|Mean
2784637|NCT00632814|Secondary|Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.|||Scores on a scale||Standard Deviation|Mean
2784638|NCT00632814|Secondary|Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment|The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).|baseline and 9 months||||Scores on a scale||Standard Deviation|Mean
2784639|NCT00632814|Secondary|Actual Monthly rFVIII-FS Consumption||Up to 9 months||||IU/kg||Standard Deviation|Mean
2784640|NCT00632814|Secondary|Number of Participants in Each Group at the End of the Study||Up to 9 months|Participants were allowed to switch treatment groups upon occurrence of joint bleed. Therefore the number of participants per group at the end of the study is different from the number of participants per group at baseline.|||Participants|||Number
2784641|NCT00632814|Secondary|Number of Participants With Joint Bleeds During the 9-month Treatment Period||Up to 9 months||||Participants|||Number
2784642|NCT00632814|Secondary|Number of Participants With Bleeding Events During the 9-month Treatment Period||Up to 9 months||||Participants|||Number
2784643|NCT00632814|Secondary|Number of Bleeds Per Participant During the 9-month Treatment Period||Up to 9 months||||bleeds per participant||Full Range|Median
2784644|NCT00632814|Primary|Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period||Up to 9 months||||Percentage of participants|||Number
2784645|NCT00632749|Secondary|Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone|"The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010).~Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated."|-0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours|Treated set||||||
2784646|NCT00632749|Secondary|Pharmacodynamic Monitoring|"Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes).~An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material."|On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only|Treated set||||||
2784647|NCT00632749|Secondary|AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)|||ng·h/L||Geometric Coefficient of Variation|Geometric Mean
2784648|NCT00632749|Secondary|AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated set (Only patients with observed cases (OC) values were analysed)|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2784649|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)|Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)|||hours||Full Range|Median
2784650|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of Cytarabine in Plasma)|Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2784651|NCT00632749|Secondary|Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||hours||Full Range|Median
2784652|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)|tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)|||hours||Full Range|Median
2784794|NCT00631488|Secondary|Change From BL to Week 4 in Fasting Plasma Glucose (FPG)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg/dL||Standard Error|Least Squares Mean
2784653|NCT00632749|Secondary|AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State|AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
2784654|NCT00632749|Secondary|AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State|AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
2784655|NCT00632749|Secondary|Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2784656|NCT00632749|Secondary|AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
2784657|NCT00632749|Secondary|AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed)|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
2784658|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of BI 811283 in Plasma)|Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2784659|NCT00632749|Secondary|Overall Survival (OS)|OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set|||days||Standard Deviation|Mean
2784660|NCT00632749|Secondary|Remission Duration|Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)|||days||Standard Deviation|Mean
2784661|NCT00632749|Secondary|Relapse Free Survival|"Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first.~Number of patients having relapse free survival are presented."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)|||participants|||Number
2784662|NCT00632749|Secondary|Event Free Survival (EFS)|EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set|||days||Standard Deviation|Mean
2784663|NCT00632749|Secondary|Partial Remission|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.~Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set|||participants|||Number
2784664|NCT00632749|Secondary|Incidence of Dose Limiting Toxicity (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)|up to 28 days of treatment|Treated set|||participants|||Number
2784665|NCT00632749|Secondary|Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)|"The severity and timing of AEs indicates how well the treatment regimen was tolerated.~Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme."|Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days|Treated set|||participants|||Number
2784795|NCT00631488|Primary|Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg/dL||Standard Error|Least Squares Mean
2787296|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population|Noninflammatory Lesion Count includes open and closed comedones.|Baseline to Week 12|ITT Population|||Lesions||Standard Deviation|Mean
2784666|NCT00632749|Secondary|Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria:~The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.~Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with < 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets > 100,000/μL.~Complete remission with incomplete blood count recovery (incomplete CR, CRi).All of the above criteria for CR had to be met, except that neutrophils < 1,000/μL or platelets < 100,000/μL in the blood."|Data collected up to cut-off date 20Oct2011, Up to 1239 days|Treated set|||participants|||Number
2784667|NCT00632749|Primary|The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.|"The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only.~It was determined using a standard 3 + 3 design with de-escalation."|up to 28 days of treatment|Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered.|||mg|||Number
2784668|NCT00632736|Secondary|Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26|"The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week."|Week 4 and Week 26|All participants enrolled into this study from parent study 101468/168 who received at least one dose of study medication. Only 74 participants completed this questionnaire at Week 4, whereas 87 participants completed this questionnaire at Week 26.|||participants|||Number
2784669|NCT00632736|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|13 February 2004 through 31 March 2010|Safety Population: all participants who received at least one dose of study medication|||participants|||Number
2784670|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.~Subscales:~CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|6-months follow-up||||units on a scale||Standard Deviation|Mean
2784671|NCT00632632|Secondary|Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)|Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.|Immediately following treatment||||percentage of MDD remission|||Number
2784672|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.~Subscales:~CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|Immediately following treatment||||units on a scale||Standard Deviation|Mean
2784673|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ODD Symptoms|parents rating all DSM symptoms of Oppositional Defiant Disorder on a 0-3 severity scale with higher scores indicating more severe symptoms and range is from 0-27 (8 DSM IV items and I item from DSM 3R)|week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
2784674|NCT00632619|Secondary|Children's Depression Rating Scale-Revised (CDRS-R) Total Score|rates 17 items of depression on a severity scale using information obtained from parent and child. Higher numbers indicate more severity symptoms and range is from 17 to 113.|Measured at Week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
2784675|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ADHD Symptoms|sum of severity rating for all 18 DSM (Diagnostic and Statistics Manual for Mental Disorders) IV ADHD symptoms and two from DSM 3R on a 0 to 3 scale obtained from parent rating; range is from 0 to 60 with higher numbers indicating more severe symptoms|Measured at Week12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
2784689|NCT00632502|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint assessment at Baseline or at any post-baseline visit|||Liters||Standard Deviation|Mean
2802451|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|1 Week|Data available at 1-week follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2784676|NCT00632619|Primary|Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe|averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.|measured at week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
2784677|NCT00632619|Secondary|Young Mania Rating Scale (YMRS) Score|rates manic like symptoms in children; 7 items ranging from 0-4 and 4 items on a 0-8 scale; higher scores indicate more severe symptom severity (min total score=0, max=60). There are no subscales. Symptom severity information is obtained from direct interview of parent and child. It was initially selected as the primary outcome but prior to commencement of data collection the Mood Severity Index (MSI) was chosen instead based on recently published work in a related study (see above).|Measured at weeks 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.|||units on a scale||Standard Deviation|Mean
2784678|NCT00632541|Secondary|Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.||24 months|Data for this secondary objective was not collected or analyzed.||||||
2784679|NCT00632541|Secondary|Assess the Overall Response Rate.||24 months|Data for this secondary objective was not collected or analyzed.||||||
2784680|NCT00632541|Secondary|Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.||6 months|Data for this secondary objective was not collected or analyzed||||||
2784681|NCT00632541|Primary|Progression-Free Survival|The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.|From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months||||months||95% Confidence Interval|Median
2784682|NCT00632502|Secondary|Maximum Plasma Concentration of Navarixin (Cmax)|Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4|Week 1, 2, 3, and 4|The analysis population was to include all participants who received at least one dose of navarixin and had navarixin plasma concentrations available for endpoint evaluation. The planned outcome measure was not evaluated.||||||
2784683|NCT00632502|Secondary|Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator.|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
2784684|NCT00632502|Secondary|Number of Participants Who Discontinued the Study Because of an Adverse Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
2784685|NCT00632502|Secondary|Number of Participants With a Laboratory Adverse Event|The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
2784686|NCT00632502|Secondary|Number of Participants With an Electrocardiogram Adverse Event|The endpoint measured was any electrocardiogram abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Week 4|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
2784687|NCT00632502|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug|||Participants|||Number
2784688|NCT00632502|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])|The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected). The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint evaluation at Baseline or at any post-baseline visit|||Score on a scale||Standard Deviation|Mean
2784690|NCT00632502|Secondary|Mean Change From Baseline in Total Asthma Symptom Score|Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card. Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments. The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms.|Baseline and Weeks 1, 2, 3, and 4|The analysis population included all randomized participants who received at least one dose of study drug and had Asthma Symptom Scores evaluated at the time points reported|||Score on a scale||Standard Deviation|Mean
2784691|NCT00632502|Secondary|Mean Change From Baseline in Sputum Absolute Neutrophil Count|Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period. Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis. An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug.|Baseline and while on study drug (up to 4 weeks)|The analysis population included all randomized participants who received at least one dose of study drug and had sputum absolute neutrophil counts at Baseline or Week 4|||Neutrophil count X10^9/L||Standard Deviation|Mean
2784692|NCT00632502|Primary|Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL|Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug|||Number of participants|||Number
2784693|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Panobinostat, twice weekly|18 months||||mg|||Number
2784694|NCT00632489|Secondary|To Evaluate the Tolerability and Preliminary Efficacy of Established Doses of LBH589 and Capecitabine With Lapatinib in a Limited Number of Patients With HER2+ Breast Cancer||18 months|||||||
2784695|NCT00632489|Secondary|To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors||18 months|||||||
2784696|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Capecitabine, BID|18 months|MTD Determination only for part I patients (per protocol)|||mg/m2|||Number
2784697|NCT00632463|Secondary|The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers||18 Days||||Participants|||Number
2784698|NCT00632463|Secondary|Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.||Study day 33||||Participants|||Number
2784699|NCT00632463|Primary|Circulating RI-001 Titer|The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.|Study day 18||||Fold Change||95% Confidence Interval|Mean
2784700|NCT00632424|Secondary|Best Overall Response|Tumor assessment was performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all clinical and radiological evidence of target lesions; Partial Response (PR) = at least 30% reduction in the sum of the longest diameter of all target lesions; Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of all target lesions; Stable Disease (SD) = neither PR nor PD criteria were met.|Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity|All treated participants who received at least one dose of ixabepilone were evaluable for tumor response.|||participants|||Number
2784701|NCT00632424|Secondary|PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time|Pharmacokinetics (PK) of ixabepilone were derived from plasma concentration versus time data. Individual patient PK parameter values were derived by standard non-compartmental methods by a validated pharmacokinetic analysis program. PK parameters include Cmax (maximum plasma concentration), Cmin (minimum plasma concentration), Tmax (time of maximum plasma concentration), AUC (0-TAU) (area under the curve in one dosing interval), T-half (plasma half-life).|Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose|Number of Participants Analyzed =All participants who received any treatment with ixabepilone and had adequate concentration profiles, n=all participants who received ixabepilone and had adequate concentration profiles at the specified time point. Cmax, Cmin, Tmax, AUC (0-TAU), and T-half were not calculated.|||ng/ml||Standard Deviation|Mean
2784702|NCT00632424|Secondary|Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval|QTc interval was defined as the measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, corrected for heart rate|Baseline (Day -1) and Day 1|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, QTc data were collected but not analyzed.||||||
2784703|NCT00632424|Secondary|Number Of Participants With Liver Function and Renal Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Clinical laboratory evaluations included liver function (alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin), and renal function (creatinine).|From first study drug administration through 30 days post dose|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, liver and renal laboratory data were collected but not summarized.||||||
2784704|NCT00632424|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB).|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.|||participants|||Number
2784789|NCT00631540|Secondary|Number of Participants With 30-day Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|30 Days|1 participant withdrew and 1 participant was lost to follow-up prior to 30 days.|||Participants|||Number
2784705|NCT00632424|Secondary|Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.|||participants|||Number
2784706|NCT00632424|Secondary|Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.|||participants|||Number
2784707|NCT00632424|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level. The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.|At the end of Cycle 1 (21 days).|Due to early study discontinuation, the MTD and RP2D of oral ixabepilone at the scheduled doses used in this study were not determined||||||
2784708|NCT00632424|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT)|DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.|During Cycle 1 (Day 0 through Day 21)|All participants who received at least one dose of ixabepilone.|||participants|||Number
2784709|NCT00632411|Primary|Continuous Abstinence|No cigarette smoking since two weeks after the target quit date.|Measured at Year 1|Participants|||Participants|||Count of Participants
2784710|NCT00632359|Primary|Time to Progression|Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: >50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. >50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. >50% increase in number of circulating lymphocytes with absolute count of at least 10,000.|From baseline to 12 months|Of the 33 participants treated, two were not evaluable for outcome assessment due to early departure from study.|||Months||95% Confidence Interval|Mean
2784711|NCT00632359|Primary|Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria|Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD.|12 Months, Disease status assessed at the End of Lenalidomide Consolidation|Of the 33 participants who were treated, two Participants were not evaluable.|||participants|||Number
2784712|NCT00632359|Primary|Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation|To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start & end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood &/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: >50% increase in sum of products of =/>2 lymph nodes on 2 consecutive examinations; One+ node must be >2 cm or appearance of new enlarged lymph nodes; >50% increase in liver &/or spleen as determined by physical examination/appearance of splenomegaly not previously present; >50% increase in circulating lymphocytes with absolute count >10,000.|Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide Consolidation|Of the three participants registered, two were not evaluable for response.|||participants|||Number
2784713|NCT00632281|Secondary|Toxicity ot the Thorax|"Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and late toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity"|up to 2 years, 9 months||||percentage of participants|||Number
2784790|NCT00631540|Primary|Primary Patency of the Treated Renal Artery|Based on ultrasound images assessed by core lab.|9 Months||||Lesions|Participants||Number
2784714|NCT00632281|Primary|Disease Status|2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)|2 yrs|44 lesions in 38 patients were treated with IMRT or 3D conformal beams on a prospective trial examining thoracic SBRT. Twenty-two of 32 primary lung cancer patients had biopsy-proven NSCLC (stage IA, 21 patients; stage IB, 11 patients). Six had metastatic disease. Six patients had 2 lesions treated simultaneously.|||percentage of participants|||Number
2784715|NCT00632229|Secondary|Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms|This assessment measures the overall severity of obsessive-compulsive symptoms. It consists of a single item that is completed by a clinician with scores ranging from 0-6 with higher scores corresponding with more severe obsessive-compulsive symptoms. Thus, higher scores represent a worse outcome.|post-treatment|Includes those subjects who were randomized to their respective condition.|||Scores on a scale||Standard Deviation|Mean
2784716|NCT00632229|Primary|Yale Brown Obsessive Compulsive Scale|This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 [Scale range: 0 (Minimum) - 40 (Maximum)] with higher scores corresponding to more severe obsessive-compulsive symptoms.|End of study (8 weeks)||||Scores on a scale||Standard Deviation|Mean
2784717|NCT00632203|Secondary|Tolerability of Maintenance Temozolomide|Tolerability was defined as number of participants with any adverse event leading to study discontinuation and/or study drug discontinuation.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)||||participants|||Number
2784718|NCT00632203|Secondary|Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13)|The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Scores range from 0 -100. For functional and global QoL scales, higher scores mean a better level of function. For symptom-oriented scales, a higher score means more severe symptoms and a decrease in QoL. The EORTC QLQ-LC13 is a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It has a score range 0-100 with higher scores representing an increase in symptoms.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.||||||
2784719|NCT00632203|Secondary|Number of Participants With Brain Metastases at First Progression|Brain Metastases were defined as radiological evidence of brain metastases on MRI.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.||||||
2784720|NCT00632203|Secondary|Overall Survival|The overall survival was analyzed using the Kaplan-Meier method.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up||||months||95% Confidence Interval|Median
2784721|NCT00632203|Secondary|Time to Progression|"The time to progression (per response evaluation criteria in solid tumors [RECIST]) was analyzed using the Kaplan-Meier method.~Definitions of response per RECIST:~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): A decrease of at least 30% in the sum of the longest~diameter of target lesions.~Progressive Disease (PD): An increase of at least 20% in the sum of the longest~diameter of target lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment||||months||95% Confidence Interval|Median
2784722|NCT00632203|Secondary|Time to Radiological Central Nervous System (CNS) Progression|"Defined as CNS progression as measured by MRI.~Time to CNS progression was analyzed using the Kaplan-Meier method."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date||||months||95% Confidence Interval|Median
2784723|NCT00632203|Primary|Number of Participants Who Had Brain Metastases|Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).|Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)|Evaluable population, defined as a participant who had at least one post-randomization MRI scan|||participants|||Number
2784724|NCT00632125|Primary|Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects|The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy|6 months|Safety population: The safety population consists of all patients that received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2784725|NCT00632099|Primary|Cocaine Abstinence Based on Urine Toxicology Results|Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)|during last 3 weeks of the trial||||participants|||Number
2784726|NCT00632021|Secondary|Number of Participants With Unplanned Hospitalizations and Emergency Department Visits|Unplanned hospitalizations and Emergency Department visits|Measured at Day 30||||Participants|||Count of Participants
2784727|NCT00632021|Primary|Number of Serious Medication Errors as Determined by Interview and Medical Chart Review|Number of clinically important medication errors per patient|Measured at Day 30||||serious medication errors||Standard Deviation|Mean
2784728|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.|||µg/L||Full Range|Geometric Mean
2784796|NCT00631475|Secondary|Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.|Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.|up to 21 months, plus 24 hours after the end of study treatment|Study population|||participants|||Number
2784729|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.|||µg*h/L||Full Range|Geometric Mean
2784730|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.|||μg/L||Full Range|Geometric Mean
2784731|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.|||μg*h/L||Full Range|Geometric Mean
2784732|NCT00631969|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of participants|||Number
2784733|NCT00631969|Secondary|Satisfaction With Medication at Week 12 or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain Satisfaction with medication at LOCF expressed as the least square mean difference."|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.|||scores on a scale||Standard Deviation|Mean
2784734|NCT00631969|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
2784735|NCT00631969|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
2784736|NCT00631969|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain  Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
2784737|NCT00631969|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain  Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
2784738|NCT00631969|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
2784739|NCT00631969|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||Sexual Attempts||Standard Deviation|Mean
2784797|NCT00631475|Secondary|Treatment-emergent Serious Adverse Events (SAE)|Number of participants with at least one SAE during the study.|up to 21 months plus 28 days after the end of study drug|Study population|||participants|||Number
2784740|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of ejaculation successes||Standard Deviation|Mean
2784741|NCT00631969|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of satisfactory attempts||Standard Deviation|Mean
2784742|NCT00631969|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of satisfactory erections||Standard Deviation|Mean
2784743|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of successful erections||Standard Deviation|Mean
2784744|NCT00631969|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of participants|||Number
2784745|NCT00631969|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of success in maintenance||Standard Deviation|Mean
2784746|NCT00631969|Primary|Change in Percentage From Baseline in Success of Penetration at 12 Weeks|Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||percentage of successful penetrations||Standard Deviation|Mean
2784747|NCT00631969|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF|The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.|||scores on a scale||Standard Deviation|Mean
2784748|NCT00631917|Primary|Summary of the End of Study Colonoscopy Results|During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.|||Percentage of Participants|||Number
2784749|NCT00631917|Secondary|Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target|The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)|Weeks 8, 30 and End of Study (54 weeks)|Full analysis set|||Percentage of Participants|||Number
2784750|NCT00631917|Secondary|Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment|Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score > 0 is worsening from baseline in which the maximum possible score is 3.|54 weeks|Primary analysis set|||participants|||Number
2784751|NCT00631917|Secondary|Percentage of Participants With Each of the Individual Components of Colonic Pathology|Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary analysis set|||Percentage of Participants|||Number
2784791|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC|GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||pmole*h/L||Standard Error|Least Squares Mean
2802452|NCT00509392|Primary|Tenderness|Tenderness 0-10 scale (10 most severe)|48 Hour|Data available at 48hr visit|||units on a scale|limbs|Standard Deviation|Mean
2784752|NCT00631917|Primary|Percentage of Participants With Colonic Pathology|The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.|||Percentage of participants|||Number
2784753|NCT00631748|Secondary|Percentage of Participants Attaining Abstinence for Three Weeks|Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12|Abstinence defined as negative UDS for 3 consecutive weeks of the trial|At end of study (12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.|||Percentage of Participants|||Number
2784754|NCT00631748|Primary|Timeline Followback Interview (TLFB)|The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks.|Grams of cocaine used at end of study (12-weeks)|At end of study(12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.|||grams of cocaine used||Standard Deviation|Mean
2784755|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 12|Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.|||percent motility||Standard Deviation|Mean
2784756|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 26|Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.|||percent motility||Standard Deviation|Mean
2784757|NCT00631696|Secondary|Change From Baseline in Sperm Motility to End of Study (EOS)|Mean sperm motility (percent motility representing grade a+b [a=sperm with progressive, straight-line motility; b=non-linear motility]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.|||percent motility||Standard Deviation|Mean
2784758|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 12|Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.|||ng/dL||Standard Deviation|Mean
2784759|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 26|Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.|||ng/dL||Standard Deviation|Mean
2784760|NCT00631696|Secondary|Change From Baseline in Testosterone to End of Study (EOS)|End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.|||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
2784761|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.|||IU/L||Standard Deviation|Mean
2784762|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT population; N=number of participants (observed cases) with analyzable data at observation.|||IU/L||Standard Deviation|Mean
2784763|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)|FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Modified intent-to-treat (MITT) population included all randomized participants who received at least 1 dose of study medication (either pregabalin or placebo) and were not discontinued for major violation at the site level. N=number of participants with analyzable data at observation; LOCF.|||IU/L||Standard Deviation|Mean
2784764|NCT00631696|Primary|Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)|Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Per protocol analysis set: all randomized participants who had ≥8 weeks of study treatment, sperm concentration measurements at or after week 12 window, did not discontinue for site violations, and did not have any major protocol violations. N=number of participants with analyzable data at observation; Last observation carried forward (LOCF).|||percentage of participants||95% Confidence Interval|Number
2784765|NCT00631670|Secondary|Overall One Year Survival|Number of patients alive at one year after treatment|One year||||participants|||Number
2784766|NCT00631670|Secondary|Pain Relief|Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.|12 weeks|Patients who reported pain at baseline|||participants|||Number
2784767|NCT00631670|Secondary|Neurologic Function|Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.|2 years|6 patients presented with tumor-related deficits before treatment.|||participants|||Number
2784768|NCT00631670|Secondary|Local Control|Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery|1 year||||tumors|Participants||Number
2784769|NCT00631670|Primary|Toxicity|"Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as acute meaning during treatment and late meaning several months after treatment ended."|2 yrs||||participants|||Number
2784770|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.|Baseline and End of 7-day Discontinuation Period|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a 7-Day Discontinuation Period IGR efficacy assessment.|||score on a scale||Standard Deviation|Mean
2784771|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 IGR efficacy assessment.|||score on a scale||Standard Deviation|Mean
2784772|NCT00631657|Other Pre-specified|Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period|SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 SF-36 efficacy assessment.|||score on a scale||Standard Deviation|Mean
2784773|NCT00631657|Other Pre-specified|Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period|"Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 How satisfied are you about your sleep duration of last night?, as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Satisfaction with Sleep Duration efficacy assessment.|||score on a scale||Standard Deviation|Mean
2788012|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
2784774|NCT00631657|Other Pre-specified|Change From Baseline in Sleep Quality - 6-Month Treatment Period|"Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 Rate the quality of your sleep last night, as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Sleep Quality efficacy assessment.|||score on a scale||Standard Deviation|Mean
2784775|NCT00631657|Other Pre-specified|Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period|"NAW was defined as the number of times recorded for sleep diary question 4a How many times did you wake up during the night?, as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline NAW efficacy assessment.|||number of awakenings||Standard Deviation|Mean
2784776|NCT00631657|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period|"WASO was defined as the time recorded for sleep diary question 5 How much time were you awake, after falling asleep initially?, as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline WASO efficacy assessment.|||minutes||Standard Deviation|Mean
2784777|NCT00631657|Secondary|Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period|"SL was defined as the time recorded for sleep diary question 3 How long did it take you to fall asllep?, as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline SL efficacy assessment.|||minutes||Standard Deviation|Mean
2784778|NCT00631657|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 27 weeks|The AST population consisted of all participants who received at least one dose of any study drug.|||participants|||Number
2784779|NCT00631657|Secondary|Number of Participants Who Experienced Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 31 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of any study drug.|||participants|||Number
2784780|NCT00631657|Primary|Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period|"TST was defined as the time recorded for sleep diary question 6 How much time did you actually spend sleeping? as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach."|Baseline and the Mean of Weeks 14-26|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline TST efficacy assessment.|||minutes||Standard Deviation|Mean
2784781|NCT00631566|Secondary|To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.|This outcome measure was not analyzed/reported due to resource limitation.|at time of positive MRSA results|As requested, the number of participants was set to zero since this analysis was not conducted.||||||
2784782|NCT00631566|Secondary|To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.|This outcome measure was not analyzed/reported due to resource limitations.|At time of infection|As requested, the number of participants was set to zero since this analysis was not conducted.||||||
2784783|NCT00631566|Secondary|To Determine the Prevalence and Incidence of MRSA Colonization of the Nares, Throat, Perirectal, Axilla, and Groin Areas Among HIV Infected Patients and to Study Changes in the Colonization Rates Over Time.||Every 6 months|Due to small numbers, the colonization in the sites other than nares, the counts were not further identified between the treatment group and the placebo group.|||Participants|||Count of Participants
2784784|NCT00631566|Primary|The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization|MRSA colonization at 6-months post-randomization|6 months|Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed.|||Participants|||Count of Participants
2784785|NCT00631540|Secondary|30-day Clinical Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.|30 Days|1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.|||Percentage of Participants|||Number
2784786|NCT00631540|Secondary|Acute Procedural Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.|Prior to Discharge|1 participant did not have core lab assessment for stenosis.|||Percentage of Participants|||Number
2784787|NCT00631540|Secondary|Technical Success|Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.|Prior to Discharge||||Percentage of Participants|||Number
2784788|NCT00631540|Secondary|Number of Participants With 9-month Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|9 Months|3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.|||Participants|||Number
2784799|NCT00631475|Secondary|Number of Patients Exposed to Bosentan Over Time|Numbers of participants exposed to bosentan treatment over time|Start to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of OL treatment, respectively.|||Participants|||Number
2784800|NCT00631475|Primary|Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)|Mean extent of exposure to bosentan treatment in months|Start of study to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of open label (OL) treatment.|||months||Standard Deviation|Mean
2784801|NCT00631449|Secondary|Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) Will be Assessed as a Secondary Outcome.||Week 24|||||||
2784802|NCT00631449|Primary|We Will Use as Our Primary Endpoint the Proportion of Subjects in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.||Week 12||||participants|||Number
2784803|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm B|"Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Periodn: Cycle (n-1)*2+1 to n*2."|Up to 384 days (the last subject study discontinuation in the Treatment Arm B)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.|||percent of total planned dose||Standard Deviation|Mean
2784804|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm A|"Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Periodn: Cycle (n-1)*3+1 to n*3."|Up to 733 days (the last subject study discontinuation in the Treatment Arm A)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.|||percent of total planned dose||Standard Deviation|Mean
2784805|NCT00631410|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.|||days||Full Range|Median
2784806|NCT00631410|Secondary|Duration of Response (DR)|Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.|||days||Full Range|Median
2784807|NCT00631410|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.|Up to the last subject completed Cycle 24 or individual study discontinuation|All enrolled subjects who 1) had a diagnosis of locally-advanced or metastatic adenocarcinoma of the colon or rectum with measurable disease at baseline; 2) had received at least one dose of the investigational product; and 3) with efficacy data available after administration of the investigational product.|||participants|||Number
2784808|NCT00631410|Secondary|Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.|||nanogram per milliliter||Full Range|Median
2784809|NCT00631410|Secondary|Plasma Concentration of Sunitinib Active Metabolite (SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.|||nanogram per milliliter||Full Range|Median
2784810|NCT00631410|Secondary|Plasma Concentration of Sunitinib|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.|||nanogram per milliliter||Full Range|Median
2784811|NCT00631410|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.|Up to 733 days (the last subject study discontinuation)|All subjects who received at least 1 dose of the study drug.|||participants|||Number
2784812|NCT00631371|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.|||months||95% Confidence Interval|Median
2784827|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks|To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Baseline and after 8 weeks of treatment||||percentage of triglycerides decrease||Standard Deviation|Mean
2784813|NCT00631371|Secondary|Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.|||percentage of participants||95% Confidence Interval|Number
2784814|NCT00631371|Secondary|Progression-Free Survival (PFS): Investigator-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.|||months||95% Confidence Interval|Median
2784815|NCT00631371|Primary|Progression-Free Survival (PFS): Independent-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|Intent-to-treat (ITT) population included all participants who were randomized to the study.|||months||95% Confidence Interval|Median
2784816|NCT00631358|Secondary|Correlation Between Biomarker Expression and the Schirmer Test|Correlation factor: TNFmRNA vs. Schirmer|Baseline to 2 weeks||||Correlation Factor|||Number
2784817|NCT00631358|Secondary|Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining|"Correlation factor:~TNFmRNA vs. NaFl staining"|Baseline to 2 weeks|No data available for the no treatment group.|||Correlation factor|||Number
2784818|NCT00631358|Secondary|Correlation Between Biomarker Expression and Tear Film Break up Time|"Correlation factor:~TNFmRNA vs. TFBUT (Tear Film Break-up Time)"|Baseline to 2 weeks||||Correlation factor|||Number
2784819|NCT00631358|Secondary|Correlation Between Biomarker Expression and Ocular Symptoms|Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).|Baseline to 2 weeks||||Correlation factor|||Number
2784820|NCT00631358|Primary|Change in Levels of Biomarkers After Dosing With Maxidex|Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.|Baseline to 2 weeks||||ddCt (Delta-Delta-Ct)||Standard Deviation|Mean
2784821|NCT00631189|Secondary|To Evaluate Clinical and Laboratory Safety|Serious Adverse Event and Adverse Event reported throughout the study|duration of study||||Adverse Events|||Number
2784822|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.||||||||
2784823|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients|To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor|from baseline and after 8 weeks of treatment||||Participants|||Number
2784824|NCT00631189|Secondary|Compare the Percentage of Variation of Phospholipase A2 (PLA2)|To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment||||percent of variation of phospholipase A2||Standard Deviation|Mean
2784825|NCT00631189|Secondary|Compare the Percentage of Variation of C-reactive Protein (CRP)|To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment||||percent of variation of C-reactive prot.||Standard Deviation|Mean
2784826|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment|To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment||||percent. Apolipoprotein B/A1 decrease||Standard Deviation|Mean
2785029|NCT00629499|Primary|Tolerability of Adjuvant Nab Paclitaxel Using Weekly Dosing Schedule Assessed by Patient Survival, Disease Recurrence, and Treatment-related Toxicity.||18 Months|Patients were analyzed if they remained alive and without evidence of recurrence.|||participants|||Number
2784828|NCT00631189|Secondary|Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment|Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|After 8 weeks of treatment||||percentage of HDL-C increase||Standard Deviation|Mean
2784829|NCT00631189|Secondary|Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment|To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment||||percentage of total cholesterol decrease||Standard Deviation|Mean
2784830|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done|||||||
2784831|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done|||||||
2784832|NCT00631189|Primary|Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks|To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Change from baseline and after 8 weeks of treatment|92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group|||percentage of LDL-C decrease||Standard Deviation|Mean
2784833|NCT00631137|Secondary|Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months||baseline and at 1, 3, and 7|only 1 subject enrolled. Not enough to do analysis||||||
2784834|NCT00631137|Secondary|Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities||while receiving treatment|only 1 subject enrolled. Not enough to do analysis||||||
2784835|NCT00631137|Secondary|Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|only 1 subject enrolled. Not enough to do analysis||||||
2784836|NCT00631137|Secondary|Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months||baseline and at 3 and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
2784837|NCT00631137|Secondary|Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
2784838|NCT00631137|Secondary|Muscle Strength Testing in Other Proximal Muscles (i.e., Knee Extensors, Knee Flexors, Arm Abductors, Elbow Extensors and Flexors, and Neck Flexors) as Assessed by Dynamometry at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
2784839|NCT00631137|Primary|Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months||baseline and at 1, 3, 5, and 7 months|Only 1 subject accrued. Not enough data to analysis||||||
2784840|NCT00631020|Secondary|Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline|Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point.|Weeks 6, 12, 16 and 24||||cigarettes/day||Standard Deviation|Mean
2784841|NCT00631020|Secondary|Change in Tobacco Dependence Compared to Baseline|Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured.|Weeks 6, 12, 16 and 24||||units on a scale||Standard Deviation|Mean
2784842|NCT00631020|Secondary|Changes in Tobacco Withdrawal Symptoms Compared to Baseline|Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined.|Weeks 6, 12, 16 and 24||||units on a scale||Standard Deviation|Mean
2784843|NCT00631020|Primary|7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)|The primary index of smoking behavior will be subject's self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm.|week 6, 12, 16 and 24||||participants|||Number
2784844|NCT00631020|Primary|Retention in Trial|Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)|week 6||||participants|||Number
2784845|NCT00631020|Primary|Acceptance of Nicotine Replacement Therapy|Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.|week 2||||participants|||Number
2802453|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|1 Month|Data available at 1 month follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2784846|NCT00631007|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.|The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.|||mg/dL||Standard Deviation|Mean
2784847|NCT00631007|Primary|Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward|HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.|||Percernt||Standard Deviation|Mean
2784848|NCT00630994|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Adverse events were assessed every cycle during treatment.|Up to 48 weeks||||participants|||Number
2784849|NCT00630994|Secondary|Number of Participants With Constitutional Symptoms|Constitutional symptoms including the presence of one or more of the following felt to be attributed to the disease: severe night sweats, fevers, weight loss and bone pain. Symptoms were assessed every cycle during treatment.|Up to 48 weeks|Study terminated prematurely. Analysis not performed.||||||
2784850|NCT00630994|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to progression of disease or death due to any cause.~Progression was defined as any one or more of the following:~1)progressive splenomegaly; 2) leukemic transformation confirmed by a bone marrow blast count of >= 20%; 3) an increase in peripheral blood blast percentage of >=20% that lasts for >= 8 weeks."|up to 3 years|Study terminated prematurely. Analysis not performed.||||||
2784851|NCT00630994|Secondary|Overall Survival(OS)|OS was defined as the time from registration to death of any cause.|up to 3 years|Study terminated prematurely. Analysis not performed.||||||
2784852|NCT00630994|Primary|Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.|"Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations >=4 weeks apart.~CR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission.~PR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (>=10cm); MI 100% INC in platelet count(>=50000x10^9/L) or ANC (>=0.5x10^9/L)"|Every 4 weeks during treatment (up to 16 weeks)|All participants who met the eligibility criteria that have signed a consent form and went on treatment were evaluable for response. The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution.|||participants|||Number
2784853|NCT00630955|Secondary|Sedation Responses to Alcohol|Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher sedation.|Day 7|Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module|||units on a scale||Standard Deviation|Mean
2784854|NCT00630955|Secondary|Stimulation Responses to Alcohol|Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation.|Day 7|Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module|||units on a scale||Standard Deviation|Mean
2784855|NCT00630955|Primary|Baseline-adjusted Craving (YCS)|Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.|Day 7||||millimeters||Standard Error|Least Squares Mean
2784856|NCT00630955|Primary|Number of Drinks Consumed on Day 7||Day 7||||standard drinks||Standard Deviation|Mean
2784857|NCT00630916|Secondary|Aortic Valve Regurgitation|Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.|12 months||||Percent of participants|||Number
2784858|NCT00630916|Primary|Effective Orifice Area|Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.|12 months||||cm^2||Standard Deviation|Mean
2784859|NCT00630916|Primary|Mean Gradient|Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.|12 months|Patients with 12 month hemodynamic evaluations|||mmHg||Standard Deviation|Mean
2784860|NCT00630916|Primary|Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair|Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant.|Late postoperative|Cumulative follow-up in years occurring post 30 days|||Percent occurrence per patient-year|Participants|95% Confidence Interval|Mean
2784861|NCT00630877|Primary|FAST Responsiveness--maximum Flushing Severity Score|The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.|||Units on a scale|||Number
2785139|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2784862|NCT00630877|Primary|FAST Responsiveness--mean Flushing Severity Score|The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.|||Units on a scale|||Number
2784863|NCT00630877|Primary|FAST Longitudinal Construct Validity--maximum Flushing Severity Score|The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
2784864|NCT00630877|Primary|FAST Longitudinal Construct Validity--mean Flushing Severity Score|The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
2784865|NCT00630877|Primary|FAST Cross-sectional Construct Validity--maximum Flushing Severity Score|The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
2784866|NCT00630877|Primary|FAST Cross-sectional Construct Validity--mean Flushing Severity Score|The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Spearman correlation coefficient|||Number
2784867|NCT00630877|Primary|FAST Test-retest Reliability--maximum Flushing Severity Score|Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.|||Intraclass correlation coefficient|||Number
2784868|NCT00630877|Secondary|Maximum Severity of Flushing Events Overall During the Study|The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.|Week 1 to Week 6|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.|||Percentage of subjects|||Number
2784869|NCT00630877|Primary|Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score|Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.|||Intraclass correlation coefficient|||Number
2784870|NCT00630864|Other Pre-specified|Change From Baseline in Troponin I Levels at Week 2, Week 6 , Month 3, Month 6, Month 12|Troponin I is a cardiac injury biomarker. Higher concentrations of this marker in blood are associated with heart injury.|Baseline, Week 2, Week 6 , Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.|||nanogram/mL||Standard Deviation|Mean
2784871|NCT00630864|Other Pre-specified|Change From Baseline in Karnofsky Performance Status Scale at Month 6, Month 12|Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
2784872|NCT00630864|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) at Week 2, Week 6, Month 3, Month 6, Month 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.|||picogram/mL (pg/mL)||Standard Deviation|Mean
2788013|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
2784873|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial (LA) Volume Index at Month 6, Month 12|LA volume index (LAVI), was the value of LA volume divided by body surface area, to measure LA size.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||milliliter/square meter (mL/m^2)||Standard Deviation|Mean
2784874|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Mass/Voltage Ratio at Month 6, Month 12|"LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. QRS score (the sum of QRS voltages in the peripheral leads) was used as an index of electrical LV mass."|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||gram/millivolt||Standard Deviation|Mean
2784875|NCT00630864|Other Pre-specified|Change From Baseline in e:e' Lateral Ratio , Ratio of Peak Mitral Early Diastolic and Atrial Contraction Velocity (E/A Ratio) at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e') (E/e') were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||ratio||Standard Deviation|Mean
2784876|NCT00630864|Other Pre-specified|Change From Baseline in Doppler Data at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Doppler principle was used to measure the mitral peak early (E) diastolic transmitral flow, mitral peak atrial (A) contraction velocity and annular velocities at the lateral and septal areas of the mitral annulus. s': systolic velocity during ejection, e': early diastolic mitral annular velocity, a': late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||centimeter per second (cm/sec)||Standard Deviation|Mean
2784877|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Pulmonary Artery Systolic Pressure (PASP) at Month 6, Month 12|Systolic right ventricular pressure can be estimated on echocardiography by adding right atrial pressure (RAP) to the trans-tricuspid gradient derived from the tricuspid regurgitation velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2784878|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Peak Velocity at Month 6, Month 12|Tricuspid peak velocity was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||meter per second (m/sec)||Standard Deviation|Mean
2784879|NCT00630864|Other Pre-specified|Change From Baseline in Aortic Annulus Diameter at Month 6, Month 12|The diameter at the base of the aortic root, the basal ring, is also called the aortic annulus diameter.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||centimeter (cm)||Standard Deviation|Mean
2784880|NCT00630864|Other Pre-specified|Change From Baseline in Isovolumetric Relaxation Time (IVRT), Mitral Deceleration Time at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. IVRT is the time between the closure of the aortic valve and the opening of the mitral valve. Mitral deceleration time (MDT) was the time taken from the maximum E point wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||msec||Standard Deviation|Mean
2784881|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||gram||Standard Deviation|Mean
2784882|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Ejection Fraction at Month 6, Month 12|Cardiac MRI was done to measure left ventricular ejection fraction (LVEF) which was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||percentage of EDV||Standard Deviation|Mean
2784883|NCT00630864|Other Pre-specified|Change From Baseline in Fractional Shortening at Month 6, Month 12|Fractional shortening (FS) is the fraction of any diastolic dimension that is lost in systole. Percent of FS was calculated as difference between end-diastolic dimension (EDD) and end-systolic dimension (EDS) divided by EDD.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||percentage of EDD||Standard Deviation|Mean
2788042|NCT00608322|Primary|Change in Sublingual Microcirculatory Flow Index (MFI)|The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.|0-2 hours of study drug administration||||units on a scale||Inter-Quartile Range|Median
2784884|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) End Systolic Volume, Left Ventricle (LV) Stroke Volume at Month 6, Month 12|Cardiac MRI was done to measure left ventricular (LV) end systolic volume, left ventricle (LV) stroke volume.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||milliliter (mL)||Standard Deviation|Mean
2784885|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial Volume at Month 6, Month 12|Left atrial volume was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||cubic centimeter (cc)||Standard Deviation|Mean
2784886|NCT00630864|Other Pre-specified|Change From Baseline in Echocardiography (ECHO) Parameters at Month 6, Month 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVED), relative LV wall thickness (RLVWT).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||millimeter (mm)||Standard Deviation|Mean
2784887|NCT00630864|Other Pre-specified|Change From Baseline in Overall Quality of Life and Individual Domains of the Short-form-36 (SF-36) at Month 6, Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health and two total scores (physical component summary [PCS] and mental component summary [MCS]. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
2784888|NCT00630864|Other Pre-specified|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, Month 12|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). mBMI was calculated by multiplying BMI by serum albumin levels [gram/liter (g/L)]. mBMI was measured as kg/m^2*g/L. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||kg/m^2*g/L||Standard Deviation|Mean
2784889|NCT00630864|Other Pre-specified|Change From Baseline in Heart Rate Response to Deep Breathing (HRDB) at Month 6 and Month 12|HRDB test was used to evaluate the cardio-vagal response. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. The main factor affecting HRDB is age, with older patients showing less heart rate variability. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as the normal deviates (Z-score), the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.|||Z-score||Standard Deviation|Mean
2784890|NCT00630864|Other Pre-specified|Change From Baseline in Nerve Conduction Studies (NCS) at Month 6, Month 12|NCS: quantitative measures of peripheral nerve dysfunction consists of 5 attributes: peroneal nerve (PN) motor distal latency, PN compound muscle action potential, PN motor conduction velocity, tibial nerve distal motor latency, sural nerve sensory nerve action potential. Normal deviates (Z-score) summated into composite score (higher score=worsened nerve fiber function). Z-score is the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||Z-score||Standard Deviation|Mean
2784891|NCT00630864|Other Pre-specified|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, Month 12|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7: scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale:0=no problem, 4=severe problem(except item 32: -2=much better, 0=about same, 2=much worse).Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptom(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12);higher score=greater impairment, for each. Total score=-2 to 138 (higher score=worse QOL).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
2784892|NCT00630864|Other Pre-specified|Change From Baseline in Total Quality of Life (TQOL) Score at Month 6, Month 12|TQOL= sum of all Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) items,a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on QOL of participants with DN; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). Total TQOL score=-2 to 138;higher score=worse quality of life.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
2785140|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2784893|NCT00630864|Other Pre-specified|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6, Month 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than [<] 2) in Neuropathy Impairment Score- Lower Limb (NIS-LL) score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, Month 12|Data on NIS-LL was reported in individual participant listings but responder status was not statistically summarized.||||||
2784894|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score-Lower Limb (NIS-LL) at Month 6, Month 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0 to 4 scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
2784895|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score (NIS) at Month 6, Month 12|NIS assessed cranial nerves(nerve 3,6; facial, palate and tongue weakness),muscle weakness (respiratory; neck, elbow(E), wrist(W), finger(F), hip, knee(K) flexion; shoulder, thumb abduction; brachioradialis; E, W, hip, K extension; F spread; toe, dorsal and plantar ankle flexors; toe extensors); score: 0-4, higher score=more weakness, reflexes(biceps and triceps brachii; brachioradialis; quadriceps femoris; triceps surae), index F and great toe sensation(touch pressure, pin-prick, vibration, joint position)score:0=normal,1=decreased or 2=absent. Total score=0-244, higher score=more impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.|||units on a scale||Standard Deviation|Mean
2784896|NCT00630864|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events||Baseline up to Month 12|ITT population included all participants who received at least 1 dose of study medication.|||participants|||Number
2784897|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Holter Monitoring Findings|Holter monitoring recorded heart rhythm. Holter monitoring abnormality criteria: any abnormality, atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (VT), sustained VT and sinus pause.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.|||participants|||Number
2784898|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|ECG: investigator assessed test to assess cardiac function. ECG abnormality criteria: any abnormality, arrhythmia, rhythm, conduction, morphology, myocardial infarction, ST segment, T waves and abnormal U waves.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.|||participants|||Number
2784899|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO: investigator assessed test to assess cardiac function. ECHO abnormality criteria: any abnormality, valvular abnormality, pericardial effusion, abnormal regional wall motion, inferior vena cava respiratory variation, posterior (P) left ventricular (LV) wall/septal (S) thickness, right ventricular thickness, ejection fraction, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A), ratio of 'E'to lateral/septal mitral annular velocity (e') (E/e'prime lateral, E/e'prime septal), E deceleration time (DT), isovolumic relaxation time (IVRT).|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.|||participants|||Number
2784900|NCT00630864|Other Pre-specified|Number of Participants With Greater Than or Equal to Grade 3 Treatment-Emergent Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.|||participants|||Number
2784901|NCT00630864|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.|||participants|||Number
2784902|NCT00630864|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The FOI is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2785141|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2784903|NCT00630864|Primary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2784904|NCT00630838|Primary|Severity of Clinical Episodes of HAEC|The severity of clinical episodes of HAEC will be stratified into three grades (mild, moderate, or severe). Grades of severity reported are based on first episodes.|6 months||||participants|||Number
2784905|NCT00630838|Primary|Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).|The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.|6 months post-pullthrough||||participants|||Number
2784906|NCT00630825|Secondary|Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).|Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.|||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
2784907|NCT00630825|Secondary|Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.|Baseline and 4 and 8 and 16 weeks|The items in the Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. Therefore, no participants were analyzed for validation purposes.||||||
2784908|NCT00630825|Secondary|Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|"The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 completely dissatisfied to 6 completely satisfied; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 all of the time to 4 none of the time; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 all of the time to 4 none of the time. These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized."|Baseline and 4 and 8 and 16 weeks|Participants in the per-protocol population with evaluable PAM-D-S questionnaire data. The per-protocol population consisted of participants who received at least one dose of study medication, had no significant protocol violations, completed the double-blind treatment phase, and were compliant with the study drug.|||percentage of participants|||Number
2784909|NCT00630825|Secondary|Change From Baseline in Lipids|Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable lipid data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Full Range|Median
2784910|NCT00630825|Secondary|Rate of Hypoglycemia Per 30 Days|Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||events per participant per 30 days||Standard Deviation|Mean
2784911|NCT00630825|Secondary|Number of Participants With a Hypoglycemic Event|A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||participants|||Number
2784912|NCT00630825|Secondary|Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores|Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Gastroparesis Cardinal Symptom Index (GCSI) questionnaire data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
2785172|NCT00627679|Primary|Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).|8 hours||||min||Standard Deviation|Mean
2784913|NCT00630825|Secondary|Nausea and Dyspepsia Measured by Visual Analog Scale|Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.|One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits|Participants who received at least one dose of LY2189265 or Placebo with evaluable nausea or dyspepsia (abdominal pain and bloating) data.|||units on a scale||Standard Deviation|Mean
2784914|NCT00630825|Secondary|Change From Baseline in Waist Circumference|Mean change from baseline in waist circumference (a measure of central obesity).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable waist circumference data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||centimeters (cm)||Standard Deviation|Mean
2784915|NCT00630825|Secondary|Change From Baseline in Body Weight|LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
2784916|NCT00630825|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2784917|NCT00630825|Secondary|Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)|Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable HOMA2-%B or HOMA2-%S data.|||percentage of HOMA2||Standard Deviation|Mean
2784918|NCT00630825|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood glucose (SMBG) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2784919|NCT00630825|Secondary|Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)|Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.|Baseline and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glucose excursion data.|||millimoles per liter (mmol/L)*minute||Standard Deviation|Mean
2784920|NCT00630825|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2784921|NCT00630825|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus|Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2784922|NCT00630786|Secondary|Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher|Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal.|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.|||participants|||Number
2784923|NCT00630786|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following:~= Mild: Aware of sign or symptom, but easily tolerated~= Moderate: Discomfort enough to cause interference with usual activity;~= Severe: Incapacitating with inability to work or do usual activity;~= Life-threatening: an event in which the patient was, in the view of the investigator, at risk of death at the time of the event;~= Fatal."|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.|||participants|||Number
2784924|NCT00630786|Secondary|Number of Participants With Anti-therapeutic Antibodies|Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay.|Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks.|Safety analysis set, including all randomized patients who received at least 1 dose of investigational product. N indicates the number of patients with immunoassay results at the specified time points.|||participants|||Number
2784925|NCT00630786|Secondary|Duation of Response|The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response||||||
2784926|NCT00630786|Secondary|Time to Response|The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response||||||
2784927|NCT00630786|Secondary|Number of Participants With Disease Control|Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||participants|||Number
2784928|NCT00630786|Secondary|Overall Survival|Kaplan-Meier estimate of time from enrollment to death from any cause|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||months||95% Confidence Interval|Median
2784929|NCT00630786|Secondary|Progression-free Survival|Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||weeks||95% Confidence Interval|Median
2784930|NCT00630786|Primary|Number of Participants With an Objective Response|An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status and Baseline measurable disease.|||participants|||Number
2784947|NCT00630734|Primary|Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*hr/ml||95% Confidence Interval|Mean
2784931|NCT00630786|Primary|Part 1: Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs.~Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities."|4 weeks|DLT-evaluable patients were those who received ≥ 2 doses of panitumumab and conatumumab as scheduled (ie, weeks 1 and 3) and completed 4 weeks (28 days) of treatment, or had a DLT within the first 4 weeks (28 days) of treatment.|||participants|||Number
2784932|NCT00630747|Primary|Change From Baseline in Mean Distance Walked in the 6-minute Walk Test (6MWT) at Week 105|Determined on a walking course. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom distance walked was recorded at baseline and at Week 105.|||meters (m)||Standard Error|Mean
2784933|NCT00630747|Secondary|Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 105|Determined by echocardiogram. LVMI indexed to body surface area (g/m^2). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom cardiac LVM were recorded at baseline and at Week 105.|||g/m^2||Standard Error|Mean
2784934|NCT00630747|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycans (GAG) Levels at Week 105|Determined by urine testing. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom normalized urine GAG levels were recorded at baseline and at Week 105.|||mcg GAG/mg creatinine||Standard Error|Mean
2784935|NCT00630747|Secondary|Change From Baseline in Mean Combined Liver and Spleen Volume at Week 105|Determined by Magnetic Resonance Imaging (MRI). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom combined liver and spleen volume were recorded at baseline and at Week 105.|||cubic centimeters (cc)||Standard Error|Mean
2784936|NCT00630747|Secondary|Change From Baseline in Mean Passive Joint Range of Motion (JROM) at Week 105|Change was calculated as Week 105 minus baseline. Global JROM (% normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline and at Week 105|All participants for whom passive JROM were recorded at baseline and at Week 105.|||percentage of JROM||Standard Error|Mean
2784937|NCT00630747|Primary|Change From Baseline in Mean Percent Predicted Forced Vital Capacity (FVC) at Week 105|Determined by spirometry. The change is calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom percent predicted FVC were recorded at baseline and at Week 105.|||percent predicted FVC||Standard Error|Mean
2784938|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
2784939|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*h/ml||Standard Deviation|Mean
2784940|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
2784941|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*h/ml||Standard Deviation|Mean
2784942|NCT00630734|Other Pre-specified|Ritonavir Maximum Plasma Concentration (Cmax)|Cmax of ritonavir over a 12-hour dosing interval|0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
2784943|NCT00630734|Other Pre-specified|Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of ritonavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*hr/ml||Standard Deviation|Mean
2784944|NCT00630734|Other Pre-specified|Darunavir Maximum Plasma Concentration (Cmax)|Cmax of darunavir over a 12-hour dosing interval|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||Standard Deviation|Mean
2784945|NCT00630734|Other Pre-specified|Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of darunavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng*h/ml||Standard Deviation|Mean
2784946|NCT00630734|Primary|Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)|Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.|||ng/ml||95% Confidence Interval|Mean
2784948|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index||Week 4|ITT|||percentage of parabasal cells||Standard Deviation|Mean
2784949|NCT00630539|Secondary|Mean Change From Baseline in Sex Hormone Binding Globulin Levels||Week 12|ITT|||nmol/L||Standard Deviation|Mean
2784960|NCT00630487|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)|Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument. The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem). The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled 'best imaginable health state' and 'worst imaginable health state'.|Baseline, Week 52, Week 78|||||||
2784961|NCT00630487|Secondary|Change From Baseline in Short Form (36) Health Survey (SF36)|Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT). Scale range 0 to 100, higher scores indicate a better health-related quality of life.|Baseline, Week 52, Week 78|||||||
2784962|NCT00630487|Secondary|Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)|Participant self administered questionnaire consisting of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life.|Baseline, Week 52, Week 78|||||||
2784963|NCT00630487|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA)-Index|HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
2784964|NCT00630487|Secondary|Change From Baseline in Safety Laboratory Assessments|Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No.|Baseline, Week 52, Week 78|||||||
2784965|NCT00630487|Secondary|Change in Executive Function and Memory in Subgroups|Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
2784966|NCT00630487|Secondary|Change From Baseline in Heart Rate|The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
2784967|NCT00630487|Secondary|Change From Baseline in Blood Pressure|Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
2784968|NCT00630487|Secondary|Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])|Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning).|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.||||||
2784969|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Waist Circumference)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
2784970|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Weight)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
2784971|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Height)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
2784972|NCT00630487|Secondary|Change in Visceral Fat Mass in Subgroups|Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).|Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.||||||
2784973|NCT00630487|Primary|Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)|Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.|Baseline, 52 weeks|Study terminated, no subjects were treated.||||||
2784974|NCT00630409|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 40 months|Due to lack of follow-up, objective could not be determined.|||participants||95% Confidence Interval|Median
2784975|NCT00630409|Primary|Response Rate|Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks for individual; Up to 40 months for cohort||||percentage of participants|||Number
2784976|NCT00630396|Secondary|90 Day Modified Rankin Scale Score|The modified Rankin Scale (mRS) was performed in person at the 90 day clinic follow-up appointment. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6. 0 represents no symptoms. 1 represents no significant disability. 2 represents slight disability. 3 represents moderate disability. 4 represents moderately severe disability. 5 represents severe disability. 6 represents death.|3 months||||Participants|||Number
2784977|NCT00630396|Secondary|Half-life of IV Minocycline|In eligible patients enrolled at Georgia Health Sciences University, blood samples were drawn for quantification of minocycline serum concentrations. This enabled the study team to determine the half life of the study drug.|For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days.||||hours|Participants|Standard Error|Mean
2784978|NCT00630396|Primary|Maximally Tolerated Dose of IV Minocycline|Investigators closely monitored each subject for evidence of minocycline intolerance. All adverse events were immediately reported for a decision whether to discontinue the study medication and/or reduce the dose. A computer program was used to determine the maximum tolerated dose. After entering information regarding doses and expected toxicities, results for each subject as they were collected were entered. The computer program informed as to (de)escalation, or maintenance of the same dose in the subsequent cohort of enrolled patients.|3 days||||mg/kg|||Number
2784979|NCT00630344|Secondary|Time to Progression (TTP)|TTP estimated with Kaplan-Meier methods is defined as the time from treatment start to when PSA progression criteria is first met, or the date of measurable or non-measurable disease progression (PD). Absent progression, patients are censored at the date of the last PSA measurement. PSA progression is a ≥25% increase over baseline or nadir PSA, whichever is lowest with a minimum increase of 5 ng/mL. If PSA declines ≥50%, PSA progression is a ≥50% PSA increase above nadir with a minimum increase of 5 ng/mL or back to pretreatment baseline, whichever is lowest. PSA progression requires 2 week confirmation. Per RECIST, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. Non-measurable PD is defined as a worsening bone scan, as indicated by the appearance of two or more new lesions, the appearance of new non-bony metastases or a requirement for radiation therapy.|PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.|The analysis dataset is comprised of all treated patients.|||weeks||Full Range|Median
2784980|NCT00630344|Secondary|Incidence of Grade 1-3 Treatment-Related Fatigue Toxicity|All grade 1-3 fatigue adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 fatigue AE during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2784981|NCT00630344|Secondary|Incidence of Grade 1-3 Treatment-Related Rash Toxicity|All grade 1-3 rash adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 rash AE during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2784982|NCT00630344|Secondary|Incidence of Grade 1-3 Treatment-Related Mucositis Toxicity|All grade 1-3 mucositis adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 mucositis AE during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2784983|NCT00630344|Secondary|Incidence of Grade 4 Treatment-Related Toxicity|All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.|Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2784984|NCT00630344|Primary|Overall Response Rate|"Overall response rate is the percentage of patients achieving response taking into consideration measurable disease, bone metastases, and PSA. PSA declines in the absence of both measurable disease and the appearance of new bone lesions or a response in measurable disease without an increase in PSA or the appearance of new bone lesions. Patients with stable disease (SD) lasting at least 6 months will also be considered responders.~Per RECIST guidelines, for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation is required within 4 weeks. Per modified PSAWG2 criteria (Scher H, Halabi S, Tannock I et al. JCO 2008) PSA response is defined as PSA decline ≥ 50% from baseline confirmed by a second measurement at least 4 weeks later."|PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.|The analysis dataset is comprised of all treated patients.|||percentage of patients||90% Confidence Interval|Number
2784985|NCT00630331|Secondary|Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.|Up to 7 days post vaccination|Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.|||Subjects|||Number
2784986|NCT00630331|Secondary|Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.|Three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.|||Percentages of subjects||95% Confidence Interval|Number
2784987|NCT00630331|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.|||Percentages of subjects||95% Confidence Interval|Number
2784988|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.|||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
2784989|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on PP efficacy population.|||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
2784990|NCT00630331|Secondary|Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done of PP efficacy population.|||Number of Medical Visits||Standard Deviation|Mean
2784991|NCT00630331|Secondary|Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done of PP efficacy population.|||Number of Medical Visits||Standard Deviation|Mean
2784992|NCT00630331|Secondary|Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.|||Number of Days||Standard Deviation|Mean
2784993|NCT00630331|Secondary|Influenza-Associated Days in Bed, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on the PP efficacy population.|||Number of Days||Standard Deviation|Mean
2784994|NCT00630331|Secondary|Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.|||Subjects|||Number
2784995|NCT00630331|Secondary|Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.|||Subjects|||Number
2784996|NCT00630331|Primary|Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.|6 Months|Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.|||Subjects|||Number
2784997|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session D- Closed Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
2784998|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session C- Open Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
2785024|NCT00629525|Secondary|Progression Free Survival|Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 315 days, with the last patient censored at 1309 days.|Intent to treat|||months||95% Confidence Interval|Median
2784999|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session B- Closed Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subject Eyes|Standard Deviation|Mean
2785000|NCT00630305|Primary|Endothelial Bleb Areas on Cornea: Session A- Open Eye|Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.|20 minutes post-lens insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percent Difference of Bleb Area|Subjects Eyes|Standard Deviation|Mean
2785001|NCT00630292|Primary|Amount of Blood Vessel Tortuosity in Breast With Known Cancer|Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy|up to two weeks prior to start of chemotheraphy|Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.|||sum of blood vessel angles|||Number
2785002|NCT00630058|Secondary|Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels|HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.|37 weeks||||Log IU / mL||Standard Deviation|Mean
2785003|NCT00630058|Primary|T1/2(Time of Half-Life) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||hours||Standard Deviation|Mean
2785004|NCT00630058|Primary|Ctrough (Minimum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
2785005|NCT00630058|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
2785006|NCT00630058|Primary|Tmax (Time of Maximum Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||hours||Full Range|Median
2785007|NCT00630058|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
2785008|NCT00629850|Primary|Change in Negative Inspiratory Force Using a Pressure Manometer||10 weeks|there was only one participant completing this study. No analyses performed.||||||
2785009|NCT00629850|Primary|Change in Maximum Voluntary Ventilation Using Pulmonary Function Device|Pulmonary function device measures flow rate in liters per minute over a period of at least 12 seconds.|10 weeks|there was only one participant completing this study. No analyses performed.||||||
2785010|NCT00629850|Primary|Number of Participants With Improvement in Sleep Quality.|Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.|10 weeks|There was only one participant completing the study. No analyses performed.||||||
2785011|NCT00629772|Secondary|Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26|Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles.|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
2785012|NCT00629772|Secondary|Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.~0 = clear~1 = almost clear~2 = Mild~3 = Moderate~4 = Severe~5 = Very severe"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
2788043|NCT00608322|Primary|Change in the Sequential Organ Failure Assessment (SOFA) Score||0-24 hours from protocol initiation|||||||
2785013|NCT00629772|Secondary|Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26.~Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.~0-1 = no effect at all on patient's life~2-5 = small effect on patient's life~6-10 = moderate effect on patient's life~11-20 = very large effect on patient's life~21-30 = extremely large effect on patient's life"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
2785014|NCT00629772|Secondary|Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26.~m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percent improvement||Standard Deviation|Mean
2785015|NCT00629772|Secondary|Mean Physician's Global Assessment (PGA) at Week 14|"Efficacy by comparing the mean Physician's Global Assessment(PGA).~0 = clear.~1 = almost clear.~2 = Mild.~3 = Moderate.~4 = Severe.~5 = Very severe."|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2785016|NCT00629772|Secondary|Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14|Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Percentage of affected area||Standard Deviation|Mean
2785017|NCT00629772|Secondary|Mean Dermatology Life Quality Index (DLQI) at Week 14|"Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.~0-1 = no effect at all on patient's life~2-5 = small effect on patient's life~6-10 = moderate effect on patient's life~11-20 = very large effect on patient's life~21-30 = extremely large effect on patient's life"|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2785018|NCT00629772|Secondary|Number of Adverse Events at Week 14|Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events|14 weeks||||Adverse Events|||Number
2785019|NCT00629772|Primary|75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0|"Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|14 weeks|The analysis was performed on the intent to treat (ITT) population. Nonresponder imputation (NRI) was used for patients who withdrew before the end of the study. They were treated as nonresponders from the point of withdrawal onward.|||Participants|||Number
2785020|NCT00629707|Secondary|Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.||twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment|||||||
2785021|NCT00629707|Primary|Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)|In both groups, brain Apparent Diffusion Coefficient (ADC) measures at 3-6 hours and 9-12 hours after beginning DKA treatment were averaged to determine overall brain ADC during DKA treatment. The brain ADC indicates the distribution of water in the brain and is an indicator of brain swelling (edema). The overall brain ADC values during DKA treatment were compared with the brain ADC measured after recovery to assess the degree of brain edema formation during DKA treatment. The difference in brain ADC, calculated as the averaged treatment values minus the recovery value, was used as the main outcome measure to indicate the degree of brain edema formation|twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment|Data from all enrolled participant that completed the study were analyzed.|||mm^2/sec||Standard Deviation|Mean
2785022|NCT00629525|Secondary|Clinical Response|"The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:~Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD"|Patients were followed for a median of 315 days||||participants|||Number
2785023|NCT00629525|Secondary|Molecular Response|Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.|Patients were followed for a median of 315 days|Immunohistochemistry (IHC) for pS6 was compared for 9 pairs of samples for which paraffin embedded tissue was available.|||percentage of decrease||Full Range|Mean
2785030|NCT00629265|Secondary|Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)|"Perceive improved in quality of life and eating ability as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients (PSS) and The Head and Neck Cancer Inventory (HNCI).~The PSS (List, et. al., 1990) is a clinician adminsitered scale that has three domains (normalcy of diet, eating in public, and understandability of speech). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best.~The HNCI (Funk, et. al., 2003) is patient administered questionnaire that has four domains (social disruption, aesthetics, speech, eating). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best."|Before and after treatment|Note: the number of participants analyzed (126) does not match the total number enrolled (170) because 44 people did not have adequate follow up data required for this secondary analysis.|||Change in PSS and HNCI score||Standard Deviation|Mean
2785031|NCT00629265|Primary|Change in Penetration-Aspiration Scale (PAS) Score|"The PAS scale is a validated 8-point ordinal scale (Rosenbek et. al 1996) in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst (material enters the airway, passes below the vocal folds, and no effort is made to eject it).~Difference in mean PAS scores after 12 weeks of therapy was analyzed between the two groups of interest: Active NMES + Swallowing Exercise versus Sham (inactive) NMES + Swallowing Exercise. PAS scores were obtained from fluoroscopy (modified barium swallow) studies adminstered at three time points - enrollment, midway through treatment (6 weeks), and at end of treatment (12 weeks). All fluoroscopy studies were sent to, and analyzed by, a blinded external central laboratory."|Before and after treatment|Note: the number of participants analyzed (125) does not match the total number enrolled (170) because 45 people did not have adequate follow up data required for this primary analysis.|||Change in points on PAS||Standard Deviation|Mean
2785032|NCT00629239|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 4 weeks of treatment||||meter||Full Range|Mean
2785033|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score|Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Scores on a scale||Full Range|Mean
2785034|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Scores on a scale||Full Range|Mean
2785035|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Score on a scale||Full Range|Mean
2785036|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment||||Scores on a scale||Full Range|Mean
2785037|NCT00629239|Secondary|The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||Score on a scale||Full Range|Mean
2785038|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
2785039|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Morning|Change from average during run-in to average during treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
2785040|NCT00629239|Secondary|Forced Expiratory Flow (FEF) 25%-75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L/s||Full Range|Mean
2785041|NCT00629239|Secondary|Inspiratory Capacity (IC)|Change from IC baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
2785042|NCT00629239|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
2785043|NCT00629239|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
2785044|NCT00629239|Secondary|Forced Expiratory Volume 1 (FEV1)|Change in (FEV1) from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment||||L||Full Range|Mean
2785045|NCT00629239|Primary|Number of Patients Experiencing Adverse Events|Number of patients who had an Adverse Event|At all study visits||||Participants|||Number
2785046|NCT00629122|Secondary|Drug Interactions and Genotypes|Impact of drug interaction between tacrolimus and clotrimazole troche vs. nystatin suspension. Evaluate genotype polymorphisms that influence CYP3A4, CYP3A5, and p-glycoprotein expression to determine impact on sublingual and oral tacrolimus delivery.|2 weeks|We were unable to assess genotype polymorphisms due to the small number of subjects enrolled in the study.||||||
2785047|NCT00629122|Primary|Tacrolimus Powder Dissolution Time|Tacrolimus Powder Dissolution Time during Sublingual Administration (minutes)|Day 3, minutes to powder dissolution||||minutes||Full Range|Median
2785048|NCT00629122|Primary|Estimated AUC 0-6|Area Under the Concentration-Time Curve from 0-6 hours (mg-hr/L)|Day 3 and Day 8, calculated based on concentrations measured between hours 0 and 6||||mg-hr/L|||Number
2785049|NCT00629122|Primary|Tmax|Time to Maximum concentration (hours)|Day 3 and Day 8, time of maximum concentration||||hours||Full Range|Median
2785050|NCT00629122|Primary|Cmax|Maximum concentration (ng/mL)|Day 3 and Day 8, at time of maximum concentration||||ng/mL||Full Range|Median
2785051|NCT00629122|Primary|C0 (ng/mL)|Trough concentration|Day 3 and Day 8, time 0 (before tacrolimus dose)||||ng/mL||Full Range|Median
2785052|NCT00629083|Secondary|Number of Incontinence Episodes|The total number of incontinence episodes experienced by the subject over three consecutive days.|12 months|This analysis was performed on the Complete Case (CC) analysis set.|||Episodes||Standard Deviation|Mean
2788044|NCT00608244|Primary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.|||participants|||Number
2785053|NCT00629083|Secondary|ICIQ-UI Short Form|The ICIQ-UI Short Form assesses the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire consists of three questions with a maximum score of 21 and a minimum score of zero (0). A lower score represents a decrease in the severity of symptoms (i.e., improvement).|12 months|Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).|||score on a scale||Standard Deviation|Mean
2785054|NCT00629083|Secondary|IQoL|The IQoL is a validated instrument consisting of 22 questions grouped into three subscales: avoidance and limiting behaviors; psychosocial impacts, and social embarrassment. It is a subject self-reported quality-of-life measure specific to urinary problems that is used to assess the impact of urinary incontinence and urinary problems and their treatment. The subject scores each question on a scale of 1 to 5 with higher scores indicating more positive responses. The maximum score was 110 points and the minimum score was 22.|12 months|Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).|||score on a scale||Standard Deviation|Mean
2785055|NCT00629083|Secondary|Number of Subjects Reporting as a Responder|At the 12-month primary endpoint follow-up visit, the subject was asked to provide her perception of treatment effectiveness by circling the most accurate description of her condition: cured/dry; much improved; improved; no change; worse. The response was dichotomized into responder or non-responder. A subject was classified as a responder if she reported that the treatment had cured, much improved, or improved her incontinence condition.|12 months|Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).|||Participants|||Count of Participants
2785056|NCT00629083|Secondary|24hr Pad Test|A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint.|12 months|Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).|||grams||Standard Deviation|Mean
2785057|NCT00629083|Primary|The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.|The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.|12 months|ITT|||Participants|||Count of Participants
2785058|NCT00629083|Primary|Primary Effectiveness Endpoint|The number of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and daily number of incontinence episodes|12 Months|Intent-to-treat (ITT) population.|||participants|||Number
2785059|NCT00629018|Secondary|Changes in Left Ventricular Function||5 years|||||||
2785060|NCT00629018|Secondary|Changes in Plasma Inflammatory Markers||6 months|||||||
2785061|NCT00629018|Secondary|Changes in Electrophysiologic Properties of Ventricular Myocardium||6 months|||||||
2785062|NCT00629018|Secondary|Changes in Exercise Capacity||5 years|||||||
2785063|NCT00629018|Primary|Changes in Left Ventricular Ejection Fraction|Left ventricular ejection fraction measured by echocardiography|5 years||||Percentage of ejection||Standard Deviation|Mean
2785064|NCT00629018|Primary|Heart Failure Mortality||5 years|The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.|||participants|||Number
2785065|NCT00628927|Secondary|Tail Length From the Comet Assay for Oxidative Damage|The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.|Single study visit||||µm||Standard Deviation|Mean
2785066|NCT00628927|Secondary|Barrett Impulsiveness Scale Version 11 (BIS-11)|"The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from Rarely/Never to Almost Always/Always and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90)."|Single study visit||||units on a scale||Standard Deviation|Mean
2785067|NCT00628927|Primary|Stroop Color-word Task|The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.|Single study visit||||seconds||Standard Deviation|Mean
2785068|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|12 months||||Scores on a scale||Standard Deviation|Mean
2785069|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|3 months||||Scores||Standard Deviation|Mean
2785084|NCT00628862|Secondary|Change in Night-time Awakenings Due to Symptoms|Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks||||scores on a scale per day||Standard Deviation|Mean
2785070|NCT00628901|Secondary|Health Related Quality of Life (HRQL)Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|Baseline||||Scores on a scale||Standard Deviation|Mean
2785071|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100.The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)."|12 months||||Scores on a scale||Standard Deviation|Mean
2785072|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|3-months||||Scores on a scale||Standard Deviation|Mean
2785073|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|Baseline||||Scores on a scale||Standard Deviation|Mean
2785074|NCT00628901|Secondary|Any Adverse Events That the Participant Experienced|Summary of investigator reported adverse events and adverse device effects, including all serious adverse events and unanticipated adverse device effects. Adverse events were collected systematically, meaning they were collected during the participant's follow-up visit, during telephone contacts, or during medical record review.|During the hospitalization stay post UFE||||events|||Number
2785075|NCT00628901|Secondary|Procedure Time|Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)|During the study procedure (measured in minutes)||||minutes||Standard Deviation|Mean
2785076|NCT00628901|Secondary|Fluoroscopy Time|Fluoroscopy is the method that provides real-time X ray imaging used for guiding a variety of diagnostic and interventional procedures. Fluoroscopy time is described as the amount of time the patient underwent fluoroscopy.|During the study procedure (measured in minutes)||||minutes||Standard Deviation|Mean
2785077|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Pain|Maximum level of pain was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no pain' and the right side (10cm) of the line represents 'worst imaginable'. The patient is asked to place a mark on the line that represents their level of pain. For example, a reading of 10cm = worst imaginable pain.|24 hours after study procedure||||cm||Standard Deviation|Mean
2785078|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Nausea|Maximum level of nausea was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no nausea' and the right side (10cm) of the line represents 'worst nausea imaginable'. The patient is asked to place a mark on the line that represents their level of nausea. For example, a reading of 10cm = worst nausea imaginable.|24 hours after study procedure||||cm||Standard Deviation|Mean
2785079|NCT00628901|Primary|Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)|MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).|24-hours post study procedure||||participants|||Number
2785080|NCT00628862|Secondary|St George's Respiratory Questionnaire (SGRQ)|Patients were asked to complete the St George's Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.|12 weeks (end of run-in to last visit)||||Scores on a scale||Standard Deviation|Mean
2785081|NCT00628862|Secondary|Use of Reliever Medication|Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|12 weeks (end of run-in to last visit)||||medication doses per day||Standard Deviation|Mean
2785082|NCT00628862|Secondary|Cough|Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks||||scores on a scale per day||Standard Deviation|Mean
2785083|NCT00628862|Secondary|Breathlessness|Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks||||scores on a scale per day||Standard Deviation|Mean
2785085|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Evening|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week||||L/min||Standard Deviation|Mean
2785086|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Morning|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week||||L/min||Standard Deviation|Mean
2785087|NCT00628862|Secondary|FVC 5 Minutes Post-dose|Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose||||percent of baseline||Full Range|Geometric Mean
2785088|NCT00628862|Secondary|FEV1 5 Minutes Post-dose|Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose||||percent of baseline||Full Range|Geometric Mean
2785089|NCT00628862|Secondary|FVC Pre-dose|Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12||||percent of baseline||Full Range|Geometric Mean
2785090|NCT00628862|Secondary|FEV1 Pre-dose|Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12||||percent of baseline||Full Range|Geometric Mean
2785091|NCT00628862|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value|from baseline up to 12 weeks||||percent of baseline||Full Range|Geometric Mean
2785092|NCT00628862|Primary|Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose|FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.|from baseline up to 12 weeks||||percent of baseline||Full Range|Geometric Mean
2785093|NCT00628758|Secondary|Mean Use of As-needed Medication Per Day During Treatment Period|Mean use of as-needed medication per day during treatment period|Daily recording during the treatment period of 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient’s estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.|||inhalations per day||Standard Deviation|Mean
2785094|NCT00628758|Secondary|Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score|Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.|Baseline and 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.|||Units on a scale||Standard Deviation|Mean
2785095|NCT00628758|Secondary|Number of Severe Asthma Exacerbations|Total number of severe asthma exacerbations per treatment group|26 weeks||||Severe Exacerbations|||Number
2785096|NCT00628758|Primary|Time to First Severe Asthma Exacerbation|Time to severe exacerbation among patients|26 weeks||||days||Standard Deviation|Mean
2785097|NCT00628628|Primary|Number of Participants With Plasma Uric Acid (UA) Response|Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.|First cycle of chemotherapy, up to 5 days||||participants|||Number
2785098|NCT00628589|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF|||Participants|||Count of Participants
2785099|NCT00628589|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
2785100|NCT00628589|Primary|Change in PANSS-EC From Baseline|The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
2785101|NCT00628498|Primary|Survival by Day+100 Post Stem Cell Transplant or Chemotherapy||Day +100 from HSCT or 100 days from start of chemotherapy|ITT Efficacy Population|||Percentage of participants alive||95% Confidence Interval|Number
2785102|NCT00628446|Secondary|Adherence to NCEP Criteria|Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria|During single data collection|38 subjects completed the data collection|||percentage of participants|||Number
2785137|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2802454|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|2 Weeks|Data available at 2-week follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2785103|NCT00628446|Primary|Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines|Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS >/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividing by the total number of subjects|During single data collection. Average duration of injury was 24.4 years +/-9.5 years||||percent agreement|||Number
2785104|NCT00628407|Primary|Sternal Force Associated With Change in Intrathoracic Pressure.|The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.|per case||||kg||Standard Deviation|Mean
2785105|NCT00628355|Primary|Clinical Response Rate|We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.|immediately, 1, 3 months after treatment||||percentage of participants|||Number
2785106|NCT00628355|Primary|Intensity of Pain|"The pain will measured by using the visual analogue scale, that is represented by a straight line of 100mm starting at absence of pain and ending at point worst pain experienced or imagined."|immediately, 1, 3 months after treatment||||millimeters||Standard Deviation|Mean
2785107|NCT00628251|Primary|Progression Free Survival (PFS)|PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)|Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)||||Months||95% Confidence Interval|Median
2785108|NCT00628251|Secondary|Best QoL Response for FACT-O Symptom Index (FOSI)|Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FOSI at baseline|||Participants|||Count of Participants
2785109|NCT00628251|Secondary|Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FACT-O at baseline|||Participants|||Count of Participants
2785110|NCT00628251|Secondary|Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)|Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for TOI at baseline|||Participants|||Count of Participants
2785111|NCT00628251|Secondary|Overall Survival (OS)|OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals|At the time of the cut-off for the final analysis of overall survival (30 April 2010)||||Participants|||Count of Participants
2785112|NCT00628251|Secondary|Confirmed RECIST Response and/or CA-125 Response|The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Percentage of participants|||Number
2785113|NCT00628251|Secondary|Best Percentage Change From Baseline in CA-125 Levels|Best percentage change in cancer antigen 125 (CA-125) levels|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Percent change||Full Range|Median
2785114|NCT00628251|Secondary|Best Percentage Change in Tumour Size|The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Percent change||Full Range|Median
2785115|NCT00628251|Secondary|Overall Duration of Response|The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Duration of response is analysed for patients experiencing a response.|||Months||95% Confidence Interval|Median
2785116|NCT00628251|Secondary|Disease Control Rate|The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Participants|||Count of Participants
2785117|NCT00628251|Secondary|Objective Response Rate (ORR)|ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)||||Participants|||Count of Participants
2785118|NCT00628251|Primary|Progression Free Survival (PFS)|PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)|Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)||||Participants|||Count of Participants
2785138|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2785119|NCT00628212|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*h / dL||Standard Error|Least Squares Mean
2785120|NCT00628212|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
2785121|NCT00628212|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
2785122|NCT00628212|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||Percent||Standard Error|Least Squares Mean
2785123|NCT00628147|Secondary|Procedure Complications||procedure and post-procedure complications within 30 days after colonoscopy||||Participants|||Count of Participants
2785124|NCT00628147|Secondary|Completion of Examinations||same day||||Participants|||Count of Participants
2785125|NCT00628147|Secondary|Neoplasm Detection Rates||same day|We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening).|||Participants|||Count of Participants
2785126|NCT00628147|Primary|Neoplasm Miss Rate||same day||||Miss rate percentage||95% Confidence Interval|Number
2785127|NCT00628134|Secondary|Peripheral Lung Dose|Change over 30 minutes in the percentage of the total deposited aerosol dose found in the peripheral lung zone. We are reporting the %peripheral dose at t=30 minus the %peripheral dose at t=0. This dose is determined based on measured radioactive counts after aerosol delivery, using nuclear medicine gamma camera images. The central lung zone is defined as a rectangle with 1/2 the height and 1/2 the width of a rectangle that surrounds the right whole lung. The peripheral zone is the portion of the lung image not included in the central lung zone.|30 minutes after delivery||||percentage of lung dose||Standard Deviation|Mean
2785128|NCT00628134|Primary|Uniformity of Aerosol Distribution|Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.|30 minutes||||ratio||Standard Deviation|Mean
2785129|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [μmol/L]||Full Range|Median
2785130|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||millimole per liter [mmol/L]||Full Range|Median
2785131|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
2785132|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
2785133|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [µmol/L]||Full Range|Median
2785134|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2785135|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|7 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2785136|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2802455|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|1 Week|Data available at 1-week follow-up visit.|||units on a scale|limbs|Standard Deviation|Mean
2785142|NCT00628030|Secondary|Parental Dietary Intake of Fat|Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.|Baseline, Posttest||||grams||Standard Deviation|Mean
2785143|NCT00628030|Secondary|Parental BMI|Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.|Baseline, Posttest||||kg/m^2||Standard Deviation|Mean
2785144|NCT00628030|Secondary|Child Quality of Life|"Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest~We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.~We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.~The current report did not provide subscores."|Basline, Posttest||||units on a scale||Standard Deviation|Mean
2785145|NCT00628030|Secondary|Child Feeding|"The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale concern about child's weight is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test)."|Basline, Posttest||||units on a scale||Standard Deviation|Mean
2785146|NCT00628030|Primary|Child BMI|Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.|Basline, Posttest||||percentile||Standard Deviation|Mean
2785147|NCT00627978|Primary|Axons With Abnormal Morphology|Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.|Baseline and Over 7 cycles of treatment, approximately 21 weeks||||percentage of axons|||Number
2785148|NCT00627926|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785149|NCT00627926|Primary|Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.|24 weeks after last planned dose of study treatment (up to Week 72)|The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785150|NCT00627926|Secondary|Fatigue Severity Scale (FSS) Total Score|FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.|Baseline, Week 4, 12, 24, 36, 48, 72|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here n signifies those participants who were evaluable for this measure at given time points for each group, respectively."|||units on a scale||Standard Deviation|Mean
2785151|NCT00627926|Secondary|Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis|FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.|Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here number of participants analyzed signifies those subjects who were evaluable for FibroTest Analysis and n signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively."|||participants|||Number
2785171|NCT00627705|Primary|Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES)|The Dosage Record and Treatment Emergent Symptom Scale (DOTES) provides information on the presence, frequency, and severity of side effects reported during the course of the trial.|4, 8, and 12 weeks|We analyzed subjects who had follow-up data available.|||participants|||Number
2785152|NCT00627926|Secondary|Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels|Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785153|NCT00627926|Secondary|Number of Subjects With Viral Relapse Planned and Viral Relapse Actual|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
2785154|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|24 weeks after last actual dose of study treatment (up to Week 72)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785155|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|12 weeks after last planned dose of study treatment (up to Week 60)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785156|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|End of treatment (up to Week 48)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785157|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785158|NCT00627926|Secondary|Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.|Week 4 and Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785159|NCT00627926|Secondary|Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785160|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 72|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)|The FA set included all randomized subjects who received at least 1 dose of any study drug.|||participants|||Number
2785161|NCT00627861|Secondary|Blood Pressure||all visits (weekly for 12 weeks)||||mm Hg|||Number
2785162|NCT00627861|Secondary|Plasma Renin Activity|The blood test, plasma renin activity or PRA, is being measured during the visits outlined.|screening, 4th, 6th, 7th, 9th, 10th, 11th, 12th weeks||||ng/mL/h|||Number
2785163|NCT00627861|Primary|Plasma Renin Concentration||5th, 6th, 7th, 9th, 10th, 11th, 12th weeks||||pg/mL|||Number
2785164|NCT00627705|Secondary|Glutathione (GSH) Metabolism Intermediates in Peripheral Blood||12 weeks|Data not collected. The measure was not analyzed. The lab was not able to measure Glutathione for the study.||||||
2785165|NCT00627705|Secondary|Sensory Profile Questionnaire (SPQ)||12 weeks|Data not collected. Measure not analyzed.||||||
2785166|NCT00627705|Secondary|Social Responsiveness Scale (SRS)|SRS total score (range 0-195); higher scores mean more social impairment|12 weeks|We analyzed subjects who had follow-up data available.|||SRS total score (range 0-195)||Standard Deviation|Mean
2785167|NCT00627705|Secondary|The Aberrant Behavior Checklist Total Score (ABC)|Total score was not analyzed since we analyzed the sub scales. Additionally, the authors of the instrument do not recommend analyzing the total score.|4, 8, and 12 weeks|Measure not analyzed.||||||
2785168|NCT00627705|Primary|Irritability Subscale of the Aberrant Behavior Checklist (ABC)|Aberrant Behavior Checklist (ABC) Irritability Subscale Score (range 0-45); higher scores mean higher irritability|baseline and 12 weeks|We analyzed subjects who had follow-up data available.|||Score (range 0-45)||Standard Deviation|Mean
2785169|NCT00627705|Primary|Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC)|Data not collected. The laboratory was not able to measure Glutathione levels.|12 weeks|Data not collected.||||||
2785170|NCT00627705|Primary|The Clinical Global Rating Scale (CGRS) Improvement Subscale Score|Score range 1-7 (lower score mean more improvement compared to baseline)|12 weeks|We analyzed subjects who had follow-up data available.|||score (range 1-7)||Standard Deviation|Mean
2785173|NCT00627679|Primary|AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.|||pg*min/mL||Standard Deviation|Mean
2785174|NCT00627679|Primary|AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010|The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.|||pg*min/mL||Standard Deviation|Mean
2785175|NCT00627679|Primary|Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).|8 hours|Patients with available data at specified time points are included in the analysis population.|||min||Standard Deviation|Mean
2785176|NCT00627679|Primary|Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.|||pg/mL||Standard Deviation|Mean
2785177|NCT00627523|Secondary|Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.|Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Kg/m2||Standard Deviation|Mean
2785178|NCT00627523|Secondary|Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.|Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Kg||Standard Deviation|Mean
2785179|NCT00627523|Secondary|Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Baseline, Months 3, 6, 12, 18 and 24.|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||SDS||Standard Deviation|Mean
2785180|NCT00627523|Secondary|Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)-(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Months 3, 6, 12, 18 and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||SDS||Standard Deviation|Mean
2785181|NCT00627523|Secondary|Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.|BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Units on a scale||Standard Error|Least Squares Mean
2785182|NCT00627523|Secondary|Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.|The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.|||Units on a scale||Standard Error|Least Squares Mean
2785183|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 12.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
2785184|NCT00627523|Secondary|Change From Baseline in Height SDS at Month 12.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
2785185|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 24.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) - (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant's growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
2785186|NCT00627523|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.|||SDS||Standard Error|Least Squares Mean
2785187|NCT00627497|Secondary|Hospital Stay||At the time of discharge||||days||Standard Deviation|Mean
2785188|NCT00627497|Secondary|Blood Loss||At the time of operation||||ml||Standard Deviation|Mean
2785189|NCT00627497|Secondary|Operative Time||at the time of operation||||hrs||Standard Deviation|Mean
2785190|NCT00627497|Secondary|Success Rate of SF-36 Health Survey|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 PCS and MCS for DIAM Device vs. Single-Level Posterior Decompression were defined as: (Post Score - Pre Score) / Pre Score>= 20%. The success rates of SF-36 PCS and MCS for DIAM vs. Posterolateral Interbody Fusion were defined as: Post Score - Pre Score >= 0.|24 month after operation||||percentage of participants|||Number
2785191|NCT00627497|Secondary|General Health Status (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|24 month after operation||||Scores on a scale||Standard Deviation|Mean
2785192|NCT00627497|Secondary|Leg Pain Success Rate|Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation||||percentage of participant|||Number
2785193|NCT00627497|Secondary|Leg Pain|"Numerical rating scales are used to evaluate leg intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. A patient's total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max)."|24 month after operation||||units on a scale||Standard Deviation|Mean
2785194|NCT00627497|Secondary|Back Pain Success Rate|Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation||||percentage of participants|||Number
2788189|NCT00607672|Secondary|Blood Product Transfusion Requirement|Percentage of patients that received blood product transfusion|From the start of surgery until discharge from hospital||||percentage of patients|||Number
2785195|NCT00627497|Secondary|Back Pain|"Numerical rating scales are used to evaluate back pain intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. A patient's total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max)."|24 month after operation||||units on a scale||Standard Deviation|Mean
2785196|NCT00627497|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 month after operation||||percentage of particpants|||Number
2785197|NCT00627497|Secondary|Success Rate of Oswestry Diability Index Scores|Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 month after operation||||percentage of participants|||Number
2785198|NCT00627497|Secondary|Oswestry Disability Index (ODI) Score|The self-administered Oswestry Disability Index (ODI) Questionnaire was used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 month after operation||||Scores on a scale||Standard Deviation|Mean
2785199|NCT00627497|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of partipants who met all of the following criteria:~Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15);~Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated);~No serious adverse event classified as surgical treatment associated;~No additional surgical procedure classified as failure."|24 months after operation||||percentage of patients|||Number
2785200|NCT00627458|Secondary|Number of Subjects Reporting Concomitant Medications||During the 4-day (Days 0-3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2785201|NCT00627458|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1, during the entire study period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2785202|NCT00627458|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2785203|NCT00627458|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.|||Participants|||Count of Participants
2785204|NCT00627458|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.|||Participants|||Count of Participants
2785205|NCT00627458|Secondary|Number of Subjects With a Vaccine Response to PT, FHA and PR|Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).|One month after the booster dose (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785206|NCT00627458|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2785207|NCT00627458|Secondary|Anti-poliovirus Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2785208|NCT00627458|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2802456|NCT00509392|Primary|Pain|Pain 0-10 scale (10 most severe)|48 Hour|Data available at 48 hr follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2785209|NCT00627458|Secondary|Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785210|NCT00627458|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2785211|NCT00627458|Secondary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785212|NCT00627458|Secondary|Number of Seroprotected Subjects Against PT, FHA and PRN|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785213|NCT00627458|Secondary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785214|NCT00627458|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785215|NCT00627458|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785216|NCT00627458|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2785217|NCT00627458|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2785218|NCT00627458|Primary|Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2785219|NCT00627458|Primary|Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2785220|NCT00627458|Primary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2785221|NCT00627458|Primary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2785222|NCT00627458|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785223|NCT00627458|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785328|NCT00626574|Secondary|To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.||first 10 days following clipping and 6 week f/u|Study terminated prematurely. Outcome measures were not analyzed.||||||
2785224|NCT00627458|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2785225|NCT00627458|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2785226|NCT00627458|Primary|Number of Subjects With a Vaccine Response to PT, FHA and PR|Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785227|NCT00627458|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785228|NCT00627458|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785229|NCT00627458|Primary|Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785230|NCT00627458|Primary|Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785231|NCT00627458|Primary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785232|NCT00627458|Primary|Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3|A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785233|NCT00627458|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785234|NCT00627458|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.|Before the booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785235|NCT00627458|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785236|NCT00627458|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Before the booster administration (At Month 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2785295|NCT00626808|Primary|Number of Outpatient Visits: 1|Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785237|NCT00627445|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2785238|NCT00627445|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
2785239|NCT00627445|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||kg||Standard Error|Least Squares Mean
2785240|NCT00627445|Secondary|The Total Increase in Total Daily Insulin Dose Per Body Weight|The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.|||U/kg||Standard Error|Least Squares Mean
2785241|NCT00627445|Secondary|Change and Daily Average in Prandial Plasma Glucose Increment|Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
2785242|NCT00627445|Secondary|Change and Daily Average in 8-point Plasma Glucose|Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
2785243|NCT00627445|Secondary|The Percentage of Subjects Achieving HbA1c Treatment Targets|The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||percentage (%) of subjects|||Number
2785244|NCT00627445|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
2785245|NCT00627406|Secondary|Pregnancy Rate||from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test||||participants|||Number
2785246|NCT00627406|Primary|Frequency of Moderate to Severe OHSS.||From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test|No power calculation was proformed.|||participants|||Number
2785247|NCT00627393|Secondary|Discontinuation of Granulocyte Transfusions Due to Toxicity or Intolerance||Measured through Day 42|||||||
2785248|NCT00627393|Secondary|Evaluation of Granulocyte Yield||Measured immediately after each granulocyte donation||||Granulocyte Yield (billion cells/liter)|Participants|Inter-Quartile Range|Median
2785249|NCT00627393|Secondary|Donor Availability (Proportion of Scheduled Granulocyte Transfusion Days on Which Granulocytes Were Available)||Measured through study completion|The unit of analysis is patient-days where a granulocyte transfusion was scheduled.|||percentage of available granulocyte days|Participants||Number
2785250|NCT00627393|Secondary|Serious Adverse Events in Granulocyte Donors||Measured at Week 1 after G-CSF administration|237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.|||participants|||Number
2785251|NCT00627393|Secondary|Long-term Survival||Measured at Month 3|All randomized subjects.|||participants|||Number
2785252|NCT00627393|Secondary|Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline||Measured through Day 42|||||||
2785253|NCT00627393|Secondary|Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis)||Measured at Days 7, 14, and 42|||||||
2785254|NCT00627393|Secondary|Fever Resolution|Fever resolution between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured through Day 42|Subjects who had fever at baseline.|||proportion of subjects, resolved fever|||Number
2785255|NCT00627393|Secondary|Overall Incidence of Adverse Effects||Measured through Day 42|All randomized subjects.|||participants|||Number
2785256|NCT00627393|Secondary|Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation|Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured at Day 42|Subjects who had allogeneic stem cell transplantation|||proportion of subjects, GVHD incidnence|||Number
2785257|NCT00627393|Secondary|Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)||Measured within 6 hours after end of transfusion|Subjects who received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.|||participants|||Number
2785258|NCT00627393|Secondary|Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies||Measured at Days 14 and 42|||||||
2785259|NCT00627393|Primary|Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response|"Microbial response was defined as follows:~A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia.~Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization."|Measured at Day 42|All adjudicated or deceased subjects in intention-to-treat analyses.|||percentage of participants|||Number
2785260|NCT00627367|Post-Hoc|Change in Numerical Rating Scale (NRS) Scores Among Patients in the Protocolized Group vs Those in the Physician Driven Group Who Received Only Intravenous (IV) Morphine|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). The comparison of hydromorphone to morphine is due to the wide use of morphine for pain management in the Emergency Department setting and the comparison of the two opioids in previous studies."|60 minutes|The Nonprotocolized group has a different value for participants analyzed for this section than the overall number of participants analyzed for the group (81 versus 110), because this is looking at only those patients who received IV morphine. Nonprotocolized left medication up to the doctor, and as such, some patients received different medication|||units on a scale||Standard Deviation|Mean
2785261|NCT00627367|Post-Hoc|Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 2 Doses of Intravenous (IV) Hydromorphone|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department)."|60 minutes|Change in N from total analyzed (26 and 22 from 108 and 110 respectively) due to looking at a subpopulation: those patients who received 2 or more doses of IV hydromorphone, versus those who received only 1 dose (see 2. Post Hoc Outcome).|||units on a scale||Standard Deviation|Mean
2785262|NCT00627367|Post-Hoc|Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 1 Dose of Intravenous (IV) Hydromorphone|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department)."|60 minutes|Change in N from total analyzed (82 and 99 from 108 and 110 respectively) due to looking at a subpopulation: those patients who only received 1 dose of IV hydromorphone, versus those who received 2 or more doses (see 3. Post Hoc Outcome).|||units on a scale||Standard Deviation|Median
2785263|NCT00627367|Primary|Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.|"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department)."|60 minutes|Protocolized group had 4 missing outcome data, Nonprotocolized missing 2 outcome data. These 6 patients were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2785264|NCT00627094|Secondary|Adverse Events|Number of Adverse events reported which were evaluated to be related or possible related to the device|Continuously from start of treatment to end of trial (day 43)||||Number of AE|||Number
2785265|NCT00627094|Secondary|Change From Baseline in Ulcer Area|Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)|Change from baseline to end of trial (day 43)|ITT population|||Relative change from baseline in percent||Standard Deviation|Median
2785266|NCT00627094|Secondary|Pain Intensity (PI) Change|Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).|Change from baseline in Pain Intensity (PI) on day 4 evening|PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.|||Change in PI since baseline||Standard Deviation|Mean
2785267|NCT00627094|Primary|Pain Relief|The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.|Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)|ITT population|||percentage of scores within category|Total Number of scores day 1-5||Number
2785268|NCT00627042|Secondary|Number of Participants With Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered by the investigator to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.|||participants|||Number
2785269|NCT00627042|Secondary|Number of Participants With Serum Anti-Ramucirumab Antibodies||Prior to dosing at baseline, Cycles 4 and 7, and 30 days after end of therapy (1 cycle=2 weeks)|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.|||participants|||Number
2785279|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at Midpoint|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|6 weeks (from initiation to midpoint)|Subjects were measured at midpoint.|||IU/L||Standard Deviation|Mean
2785296|NCT00626808|Primary|Number of Outpatient Visits: 0|Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785270|NCT00627042|Secondary|Duration of Response|Duration of response was the interval from the date of initial documented response [complete response (CR) or partial response (PR)] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy was first reported, or death due to any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target lesions, PR was having at least a 30% decrease in the sum of the longest diameter of target lesions, and disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data were censored for participants who did not progress or die.|Time of first response (CR or PR) to disease progression, or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Participants who received at least 1 dose of ramucirumab and had a CR or PR. The number of participants censored 2.|||months||95% Confidence Interval|Median
2785271|NCT00627042|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions. PR was having at least a 30% decrease in sum of longest diameter of target lesions.|First dose to date of objective progressive disease (PD) or death up to 18 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
2785272|NCT00627042|Secondary|Overall Survival|Overall survival (OS) was the duration from first dose to death due to any cause. OS was censored at last contact date for participants who were alive at the end of follow-up period or lost to follow-up.|First dose to death due to any cause up to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 10.|||months||95% Confidence Interval|Median
2785273|NCT00627042|Secondary|Time to Progression|The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion. Time to PD was censored at the date of death or study discontinuation.|First dose to date of PD [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 20.|||months||95% Confidence Interval|Median
2785274|NCT00627042|Primary|Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer Treated With the Monoclonal Antibody Ramucirumab|PFS was defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who were alive and without disease progression and participants who did not progress and were subsequently lost to follow-up were censored at the last objective tumor assessment.|First dose to date of progressive disease or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 13.|||months||95% Confidence Interval|Median
2785275|NCT00627016|Secondary|Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.|||Percentage of participants|||Number
2785276|NCT00627016|Secondary|Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.|||Percentage of participants|||Number
2785277|NCT00627016|Primary|Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.|Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.|4 Weeks|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment.|||Percentage of nights||Inter-Quartile Range|Median
2785278|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at End of Treatment|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|12 weeks (from initiation to end of treatment)|ITT|||IU/L||Standard Deviation|Mean
2785280|NCT00626925|Secondary|Severity of Alcohol-related Problems at End of Treatment|The Short Inventory of Problems (SIP). The SIP, a 15-item instrument, yields a total score that ranges from 0 to 45, higher score indicating higher levels of drinking problems. The SIP was derived from the Drinker Inventory of Consequences (DrInC), which was developed for use in Project MATCH (Miller and Tonigan 1995). We (Feinn et al. 2003) have found that, like the DrInC, the SIP measures a single factor of alcohol-related problems. Given that it is substantially shorter than the DrInC, we will use the SIP as a measure of alcohol-related consequences.|12 weeks (from intiation to end of treatment)|Subject were measured at Baseline and Endpoint.|||units on a scale||Standard Deviation|Mean
2785281|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT|||Mean Abstinent Days Per Week||Standard Error|Mean
2785282|NCT00626925|Secondary|Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT|||Mean Heavy Drinking Days Per Week||Standard Error|Mean
2785283|NCT00626925|Secondary|Mean Daily Alcohol Consumption||12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment|Intention to Treat|||Standard Drinks per day||Standard Deviation|Mean
2785284|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group||12 weeks|Intention to treat (ITT).|||Mean abstinent days per week||Standard Error|Mean
2785285|NCT00626925|Primary|Mean Heavy Drinking Days Per Week by Medication Group|Change in the number of heavy drinking days during treatment phase of study. Drinking data were aggregated to the weekly level. The number of days per week of heavy drinking (i.e., four or more drinks in a day for women and five or more drinks in a day for men) and of abstinence were the primary outcomes.|12 weeks (from initiation to end of treatment)|Intention to treat (ITT)|||Number of heavy drinking days||Standard Error|Mean
2785286|NCT00626912|Secondary|Number of Participants With Serious Adverse Events|Number of participants having experienced one or several Serious Adverse Events|18 months|"For the Platinum coils population (222):~Secondary outcome measure applies to 222 participants.~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants"|||Participants|||Count of Participants
2785287|NCT00626912|Secondary|Number of Participants With Adverse Events|Number of participants having experienced one or several Adverse Events. This measure is the number of participants having experienced Serious Adverse Events plus those having experienced other (not including Serious) Adverse Events.|18 months|"For the Platinum coils population (222):~Secondary outcome measure applies to 222 participants.~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants"|||Participants|||Count of Participants
2785288|NCT00626912|Secondary|Mortality Rate|Number of participants dead - All causes|18 months|"For the Platinum coils population (222):~Secondary outcome measure applies to 222 participants.~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants"|||Participants|||Count of Participants
2785289|NCT00626912|Primary|Recurrence Rate of Target Aneurysm.|"major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation;~retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period;~an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee."|18 months|"For the Platinum coils population (222):~Primary outcome available for 220/222 (could not attribute primary outcome for 2 participants)~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222) Primary outcome available for 215/222 (could not attribute primary outcome for 7 participants)"|||Participants|||Count of Participants
2785290|NCT00626821|Primary|Quality of Life (Scale 0(Worst)-100(Best))|The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.|6-8 weeks|ITT|||units on a scale||Standard Deviation|Mean
2785291|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785292|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785293|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785294|NCT00626808|Primary|Number of Outpatient Visits: 2 or More|Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785297|NCT00626808|Primary|Geographic Region: Western|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785298|NCT00626808|Primary|Geographic Region: Southern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785299|NCT00626808|Primary|Geographic Region: North Central|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785300|NCT00626808|Primary|Geographic Region: Northeastern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785301|NCT00626808|Primary|Vaccinating Physician Specialty: Unknown|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
2785302|NCT00626808|Primary|Vaccinating Physician Specialty: Other|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
2785303|NCT00626808|Primary|Vaccinating Physician Specialty: General/Family Practitioner|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
2785304|NCT00626808|Primary|Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist|Specialty of vaccinating physician who provided FluMist.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of physicians|||Number
2785305|NCT00626808|Primary|FluMist Use in Participants up to 59 Months of Age|Among participants up to 59 months of age who received any flu vaccine, number who received FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.|||Number of participants|||Number
2785306|NCT00626795|Secondary|Participants With Clinical Cure According to Investigator's Assessment|At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator.|At Day 4|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
2785307|NCT00626795|Secondary|Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples|"At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator.~At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based."|At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up|All participants randomized to blinded treatment who received at least one application of study medication and were infected with S. aureus or S. pyogenes at baseline were included in the analysis.|||Participants|||Count of Participants
2785308|NCT00626795|Secondary|Participants With Bacteriological Cure According to Bacteriological Samples|"At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on.~Bacteriological cure was either of the following:~Eradication of the baseline pathogen.~Presumed eradication of the baseline pathogen~Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic.~Bacteriological failure was any of the following:~Documented lack of eradication of the baseline pathogen.~Documented relapse (re-infection) with the baseline pathogen~Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic~Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection."|At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up|Only the randomized participants that were infected with S. aureus or S. pyogenes at baseline were included in the analysis.|||Participants|||Count of Participants
2785309|NCT00626795|Secondary|Participants With Clinical Cure According to Investigator's Assessment.|At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.|At end of treatment (Day 8) and follow-up (Day 15)|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
2785310|NCT00626795|Secondary|Participants With Clinical Cure According to Investigator's Assessment|At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator.|At follow up (Day 15)|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
2785327|NCT00626574|Secondary|To Determine if Procrit® Administration Prior to Aneurysm Clipping in Patients With Aneurysmal SAH Will Improve Neurological Assessment Scores in the Post-SAH/Post-clipping Time Period||First 10 days following clipping and 6 week f/u|Study was terminated prematurely and outcome measures were not analyzed.||||||
2785311|NCT00626795|Primary|Participants With Clinical Cure According to Investigator's Assessment|"At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator.~Investigator's assessment of severity of infections (SIRS).~Exudates/pus~Crusting~Erythema~Oedema~Tissue Warmth~Itching~Pain~Each sign/symptoms of infection was assessed by use of the following 4-point scale:~0 = absent~2 = mild~4 = moderate~6 = severe~The scores were summed up to a total SIRS score.~Clinical cure was either of the following:~Total absence of signs and symptoms of impetigo/SITL OR~Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4.~Clinical failure was either of the following:~Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure~Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up)."|At end of treatment (Day 8)|All participants randomized to blinded treatment who received at least one application of study medication were included in the efficacy analysis. Two participants (one from TD1414 BID and one from Bactroban® TID) did not receive any study medication and are therefore not included.|||Participants|||Count of Participants
2785312|NCT00626782|Secondary|Post-Operative Requirement for Glaucoma Medication|Mean number of glaucoma medications used by each participant over the course of one year post-operatively.|1 day, 2 wks, 1, 3, 6 and 12 months||||number of glaucoma medications used||95% Confidence Interval|Mean
2785313|NCT00626782|Primary|Adverse Events|Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.|12 months||||percentage of participants|||Number
2785314|NCT00626743|Secondary|Maximal Change From Baseline in Standing DBP||within 8 hrs after SK3530 or placebo||||mmHg||Standard Deviation|Mean
2785315|NCT00626743|Primary|Maximal Change From Baseline in Standing SBP||within 8 hrs after SK3530 or placebo||||mmHg||Standard Deviation|Mean
2785316|NCT00626639|Secondary|Overall Survival|Deaths during long-term follow up of subject participating in the acute phase of the study receiving placebo or Palifermin.|During long-term follow-up phase, until December 2015|Subjects who received placebo duringthe acute phase of the study.|||Participants|||Count of Participants
2785317|NCT00626639|Secondary|Number of Participants With Disease Progression by Week 12|Disease progression was determined by clinical examination and histopathologic examination by the Investigator.|Up to Week 12|Tumor response data was missing for one participant.|||participants|||Number
2785318|NCT00626639|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Questionnaire for Head and Neck Cancer [OMQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).|||||||
2785319|NCT00626639|Secondary|Number of Participants With Severe Oral Mucositis (OM) (Adapted RTOG/EORTC Grade ≥3)|"The adapted RTOG/EORTC mucositis assessment scale as follows: Grade 0 = no change; Grade 1 = mild enanthema, mild pain; Grade 2 = patchy mucositis, moderate edema, moderate pain; Grade 3 = confluent fibrinous mucositis, massive edema, massive pain; Grade 4 = extensive ulceration, confluent necrosis, massive hemorrhage.~Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).|||||||
2785320|NCT00626639|Primary|Pharmacokinetics of Palifermin|Due to the small sample size this analysis was not performed.|Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose|||||||
2785321|NCT00626639|Primary|Ratio of Ki67-positive Cells Before and After Palifermin Treatment|The effect of palifermin on cell proliferation was to be assayed by staining for the cell cycle proliferation marker Ki67 in buccal mucosal biopsy samples taken prior to the first dose and either 24 or 48 hours after the first dose. Due to the small sample size, this analysis was not performed.|Day -3 predose and 24 or 48 hours post-dose|||||||
2785322|NCT00626639|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is an undesirable medical occurrence (sign, symptom, or diagnosis) or worsening of a pre-existing medical condition occurring after start of study drug up to the end of acute oral mucositis (OM) evaluation phase, whether or not considered to be study drug related. If severe OM was not resolved by Week 12, AEs were documented until resolution of severe OM or Week 15, whichever occurred first. A serious AE is any event that is fatal, life threatening, requires or prolongs hospitalization, is a persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3 based on the following: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death related to AE. A Protocol-specific Limiting Toxicity (PSLT) is any non-hematologic Grade 3 or 4 AE considered related to study drug.|Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)||||participants|||Number
2785323|NCT00626626|Secondary|Overall Survival|Observe overall survival in leukemia and lymphoma patients receiving transplant after clofarabine and cyclophosphamide conditioning.|2 years||||Participants|||Count of Participants
2785324|NCT00626626|Secondary|Disease-Free Survival|Observe disease free survivals in acute leukemia and lymphoma patients receiving allogeneic hematopoietic transplant after Clofarabine and cyclophosphamide conditioning.|Two years||||Participants|||Count of Participants
2785325|NCT00626626|Primary|Engraftment of Allogeneic Blood Cells.|"Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment.~Adequacy of engraftment will be assessed via assessment of chimerism (percent donor engraftment). Less than 20% engraftment by day 30 is then failure of engraftment.~Safety is defined per common toxicity criteria - Non-Hematological and non renal toxicities of ≥grade 3 or ≥grade 4 up to day 30 are scored as toxicity."|two years||||Participants|||Count of Participants
2785326|NCT00626574|Secondary|To Determine the Feasibility of Organizing a Larger, Randomized Study to Explore the Neuroprotective Effect of Procrit® in Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) When Procrit® is Administered Prior to Surgical Clipping of the Aneurysm.||When all data is collected and analyzed|Study was terminated prematurely and outcome measures were not analyzed.||||||
2785329|NCT00626574|Primary|Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping|Number of adverse events|First 10 days following clipping and 6 week F/U|Pilot Study- per protocol|||adverse events|||Number
2785330|NCT00626561|Primary|Progression-free Survival (PFS)|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Baseline to 6 Months, or until disease progression.|Interim analysis was to be done after 10 patients enrolled, accrual not met. Study halted early.||||||
2785331|NCT00626548|Secondary|Time to Symptomatic Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks|||||||
2785332|NCT00626548|Secondary|Time to Prostate-specific Antigen (PSA) Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks|||||||
2785333|NCT00626548|Secondary|Health Related Quality of Life||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks|||||||
2785334|NCT00626548|Primary|Progression Free Survival|Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)|||Participants|||Number
2785335|NCT00626548|Primary|Overall Survival|Number of participants who have died at early analysis data cut off (DCO)|From date of randomization until date of death, assessed up to 33 months|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)|||Participants|||Number
2785336|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-6 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
2785337|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-3 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
2785338|NCT00626522|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
2785339|NCT00626522|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
2785340|NCT00626522|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-12 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments|||Liters||95% Confidence Interval|Least Squares Mean
2785341|NCT00626444|Secondary|Duration of Response||10 weeks|||||||
2785342|NCT00626444|Primary|Progression-free Survival||10 weeks|||||||
2785343|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.|||Percent suppressed||90% Confidence Interval|Number
2785344|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/mL||Standard Error|Mean
2785345|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/mL||Standard Error|Mean
2785401|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs||||number of cells/g of sputum||Standard Deviation|Mean
2785346|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
2785347|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
2785348|NCT00626431|Primary|Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted|The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48||||Percent Suppressed||90% Confidence Interval|Number
2785349|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
2785350|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
2785351|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population|Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
2785352|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population|Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.|||ng/dL||Standard Error|Mean
2785353|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.|||Percent Suppressed||90% Confidence Interval|Number
2785354|NCT00626405|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years||||Months||95% Confidence Interval|Median
2785415|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18||Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm/year||Standard Deviation|Mean
2785355|NCT00626405|Secondary|Tumor Response Rate, Calculated as a Percentage Along With it's 95% Confidence Interval|"A confirmed tumor response is defined to be a Complete Response or Partial Response noted~> as the objective status on 2 consecutive evaluations at least 8~> weeks apart. The proportion of tumor responses will be~> estimated by the number of confirmed tumor responses divided~> by the total number of evaluable patients.~> Complete Response (CR): Disappearance of all target lesions~> Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.~> Progression (PD): At least a 20% increase in the sum of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~> Stable Disease (SD): Neither sufficient shrinkage to Qualify for PR nor sufficient increase to Qualify for PD taking as reference the smallest sum LD. responses will be calculated assuming that the number of~> confirmed tumor responses follows a binomial distribution."|Up to 5 years||||percentage of patients with response||95% Confidence Interval|Number
2785356|NCT00626405|Primary|Progression-free Survival at 6 Months|The primary endpoint is the 6 month post registration Progression-free survival (PFS) rate. Progression-free survival time is defined as the time from registration to documentation of disease progression using the RECIST criteria. Patients who died without documentation of disease progression will be considered to have progressed at death unless there is sufficient documented evidence to conclude no progression occurred prior to death. All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 6 month PFS rate.|at 6 months|The first 41 eligible patients randomized to each treatment arm.|||% of patients alive and progression free||90% Confidence Interval|Number
2785357|NCT00626392|Secondary|Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Number of Events per Subject per Week||Standard Deviation|Mean
2785358|NCT00626392|Secondary|Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Scores on a Scale||Standard Deviation|Mean
2785359|NCT00626392|Secondary|Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Percentage of Subjects|||Number
2785360|NCT00626392|Primary|Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|From Baseline to end of Week 1|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).|||Percentage of Subjects|||Number
2785361|NCT00626366|Primary|To Measure the Distribution of Nasal Sprays and Drops.|CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.|2 months|Each participant's CT scan will be scored for left and right sides for a total of 18 sinonasal cavities|||nasal cavities (right and left sides)|nasal cavities (right and left sides)||Number
2785362|NCT00626340|Primary|Comparison of Cortical GABA Levels in 4 Groups of Subjects Using Estrogen Alone, Fluoxetine Alone, Estrogen and Fluoxetine Combined in Pre and Post 4.0T Magnetic Resonance Spectroscopy Sessions.|"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.~We only know that 18 participants completed, but as far as we know data was never analyzed for these 18 participants."|Healthy controls will undergo scans pre and post 3 weeks of estrogen treatment. Women with depression will undergo scans pre and post 6 weeks of treatment with estrogen alone, estrogen and fluoxetine, or fluoxetine alone|UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.||||||
2785363|NCT00626327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.|Day 1- Day 180 (Through out the study)|This analysis was done on the safety set population|||Participants|||Number
2788325|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49||Days 49|mITT dataset|||percentage of lesions|Participants|95% Confidence Interval|Number
2785364|NCT00626327|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination|"Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.~Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature."|upto 7 days after any vaccination|The analysis was performed on the safety set population|||Participants|||Number
2785365|NCT00626327|Secondary|Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine|The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2785366|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2785367|NCT00626327|Secondary|Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.|"The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .~Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2785368|NCT00626327|Secondary|Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.|The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.|6 weeks post vaccination|"The analysis was performed on the MMRV per-protocol population.~Only subjects with a baseline titer below the specified cut-off for that antigen were included in the immunogenicity analysis for the same antigen."|||Titers||95% Confidence Interval|Geometric Mean
2785369|NCT00626327|Secondary|Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine|The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2785370|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2785371|NCT00626327|Primary|Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine|The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2785372|NCT00626327|Primary|Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.|"Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.~The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).~The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup."|6 weeks post second dose|The analysis was performed on the MenACWY per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2785373|NCT00626327|Primary|Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine|"Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.~Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.~Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella)."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2785765|NCT00623623|Secondary|Number of Patients With All Cause Death and Shock and Reinfarction|This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785374|NCT00626275|Primary|"Part B: The Mean of Daily Average Now Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period"|"Participants assessed their Now LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.~LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline Now LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary."|Baseline through 2 Weeks|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Error|Least Squares Mean
2785375|NCT00626275|Secondary|Part A: Participant's Global Evaluation of Study Medication|"For each treatment period during Part A, each participant's global evaluation (overall impression) of study medication was obtained 6 hours after dosing. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from excellent to poor. Participant counts per score were reported once in Part A."|6 hours post dose during Treatment Periods 1, 2, and 3 of Part A|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||participants|||Number
2785376|NCT00626275|Secondary|Part B: Percentage of Participants Using Rescue Medication|The percentage of participants who took at least 1 dose of rescue medication during 2-week treatment period of Part B is presented.|Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||Percentage of Participants|||Number
2785377|NCT00626275|Secondary|Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period|During Part B, participants returned to the clinic for 2 additional visits at approximately weekly intervals for assessments of Overall Pain Index (OPI). Participants rated their OPI on an 11-point Numeric Pain Rating Scale (NPRS) with 0 indicating No Pain and 10 indicating Worst possible pain|Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
2785378|NCT00626275|Secondary|Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2|Each day during Part B, participants rated their Lower Extremity Pain Intensity over the last 24 hours on an 11-point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain|Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
2785379|NCT00626275|Secondary|Part B: Participants' Global Evaluation of Study Medication|"For Part B, each participant's global evaluation (overall impression) of study medication was obtained at each weekly visit. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from excellent to poor. Participant counts per score were reported at Week 1 (Day 7) and Week 2 (Day 14)."|Up to Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||Participants|||Number
2785380|NCT00626275|Secondary|Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores|Percentage was measured by identifying the number of participants who achieved the desired percentage Reduction From Baseline in ELEPI Score at either 2, 4, and 6 hours post dose and was divided the by the number of total participants in the given group and then multiplied by 100 to equate to a percentage.|Up to 2, 4, and 6 hours post dosing|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||Percentage of Participants|||Number
2785381|NCT00626275|Secondary|Part A: Mean Peak Difference in ELEPI According to the NPRS Scale|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point NPRS. Participants were asked to rate their lower extremity pain on an 11 point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Peak ELEPID was defined as the maximum of ELEPIDs recorded at 2, 4, and 6 hours post dose. Difference = predose (baseline) NPRS score - peak NPRS score up to 6 hours post dose.|Baseline, Up to 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
2785382|NCT00626275|Secondary|Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Difference = predose (baseline) ELEPI score - ELEPI score 4 hours post dose.|Baseline, 4 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose|||units on a scale||Standard Deviation|Mean
2785383|NCT00626275|Secondary|Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain|Overall Pain Intensity (OPI) was assessed by the participant using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours after dosing. Difference = predose (baseline) OPI score - OPI score 6 and 12 hours post dose.|Baseline, 6 and 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
2785766|NCT00623623|Secondary|Number of Patients With All Cause Death and Shock and CHF|This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported.|30 days|FAS|||Participants|||Count of Participants
2785384|NCT00626275|Secondary|Part B: Mean Daily LEPI Scores for Weeks 1 and 2|"Participants assessed their Now LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken."|Baseline through Week 1 and Week 1 through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
2785385|NCT00626275|Secondary|Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain|"Overall Pain Intensity (OPI), Now Lower Extremity Pain Intensity (LEPI), and Evoked Lower Extremity Pain Intensity (ELEPI) were assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours (hr) after dosing. At 15 minutes before dosing, during Period 1 only, participants were also asked to assess their average LEPI over the last 24 hours as a baseline measurement. Now LEPI was assessed at 15 minutes before dosing for baseline and at the 1-, 2-, 3-, 4-, 5-, 6-, and 12-hour time points. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then (after the Now LEPI assessment) he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI."|Baseline up to 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Deviation|Mean
2785386|NCT00626275|Primary|Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing|"Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose.~Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence."|Baseline through 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.|||units on a scale||Standard Error|Least Squares Mean
2785387|NCT00626210|Secondary|Improvement of Daytime Alertness and Quality of Life.||~1 month|||||||
2785388|NCT00626210|Primary|Nocturnal Sleep Length at 1 Month||1 month||||hours||Full Range|Median
2785389|NCT00626093|Secondary|Defibrillation Threshold Difference Obtained in Joules (J)||Baseline and 6 months||||Joules||Standard Deviation|Mean
2785390|NCT00626093|Primary|Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months|All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.|Baseline and 6 months||||Volts||Standard Deviation|Mean
2785391|NCT00626028|Secondary|Number of Participants With Related Surgical Procedures Within 3 Years|Number of participants who received surgery related to pulmonary or cardiac disease within 3 years|within 3 years|Participants in the intent to treat population who completed the study|||Participants|||Count of Participants
2785392|NCT00626028|Secondary|Number of Participants With Serious Adverse Events (SAEs)|SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs.|within 12 hours|Participants in the intent to treat analysis set who completed the study|||Participants|||Count of Participants
2785393|NCT00626028|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity.|on Day 1|All participants in the intent to treat analysis set who completed the study|||Participants|||Count of Participants
2785394|NCT00626028|Secondary|Number of Participants With Related Surgical Procedures Within 1 Year|Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.|within 1 year|All participants in the intent to treat analysis set who completed the study|||Participants|||Count of Participants
2785395|NCT00626028|Primary|Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)|A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)|on Day 1|All participants in the intent to treat analysis set who completed the study|||Participants|||Count of Participants
2785396|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||72 hrs|||||||
2785397|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||24 hrs|||||||
2785398|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||7 hrs|||||||
2785399|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant.||Before inhalation (0hrs)|||||||
2785400|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs||||number of cells/g of sputum||Standard Deviation|Mean
2785402|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||mm||Standard Error|Least Squares Mean
2785403|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||Millimeter (mm)||Standard Error|Least Squares Mean
2785404|NCT00625872|Secondary|Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion). The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785405|NCT00625872|Secondary|Change From Baseline in Head Circumference at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785406|NCT00625872|Secondary|Body Mass Index-Standard Deviation Score (BMI-SDS)|The BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg) divided by the height (m) squared. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2785407|NCT00625872|Secondary|Sitting Height-Standard Deviation Score (SDS)|Sitting height was measured using a stadiometer with a specialized chair. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785408|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.|||m/s||Standard Error|Least Squares Mean
2785409|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Meter/second (m/s)||Standard Error|Least Squares Mean
2785410|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Newtons||Standard Error|Least Squares Mean
2785411|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm/year||Standard Error|Least Squares Mean
2785412|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||cm/year||Standard Error|Least Squares Mean
2785413|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Error|Least Squares Mean
2785414|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Error|Least Squares Mean
2785416|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm/year||Standard Deviation|Mean
2785417|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785418|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
2785419|NCT00625872|Secondary|Mean Growth Velocity at Months 12 and 18|Growth velocity measures the annual rate of increase in height.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm/year||Standard Deviation|Mean
2785420|NCT00625872|Secondary|Mean Growth Velocity at Month 6|Growth velocity measures the annual rate of increase in height.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm/year||Standard Deviation|Mean
2785421|NCT00625872|Secondary|Mean Height at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785422|NCT00625872|Secondary|Mean Height at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
2785423|NCT00625872|Secondary|Mean Calf Circumference|Calf measurements were taken as a mean of 3 consecutive measurements at largest part of calf muscle, usually about 4 inches down from below the knee.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785424|NCT00625872|Secondary|Mean Thigh Circumference|Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||cm||Standard Deviation|Mean
2785425|NCT00625872|Secondary|Mean Upper Arm Circumference||Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||centimeter (cm)||Standard Deviation|Mean
2785426|NCT00625872|Other Pre-specified|Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone stability was measured by pqCT. Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- (or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||z-score||Standard Error|Least Squares Mean
2785427|NCT00625872|Other Pre-specified|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone structure was measured by pqCT.Parameters included:total area,cortical area,marrow area,cortical thickness,cortical density of the radius,bone strength,cross-sectional muscle and fat area,total bone density,bone mineral count,trabecular BMD,bone cross-sectional area.Baseline and post-baseline SDS values transformed to age and sex specific z-score([Ln(test result/M)]/S);Ln=natural logarithm;M=age-/height- and sex-specific mean value;S=age-/height- and sex-specific coefficient of variation).Positive values are above the average for participant's age and sex;negative values are below.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||z-score||Standard Error|Least Squares Mean
2785428|NCT00625872|Other Pre-specified|Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone Mineral Density (BMD) was measured by pqCT. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population and more positive scores indicate higher BMD compared to age matched population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||z-score||Standard Error|Least Squares Mean
2785429|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kg||Standard Error|Least Squares Mean
2785430|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||kg||Standard Error|Least Squares Mean
2785767|NCT00623623|Secondary|Number of Patients With All Cause Death and Shock|This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785431|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||seconds||Standard Deviation|Mean
2785432|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kN||Standard Deviation|Mean
2785433|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kW||Standard Deviation|Mean
2785434|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||seconds||Standard Deviation|Mean
2785435|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||seconds||Standard Deviation|Mean
2785436|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||m/s||Standard Deviation|Mean
2785437|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||m/s||Standard Deviation|Mean
2785438|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kN||Standard Deviation|Mean
2785439|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||kilonewton (kN)||Standard Deviation|Mean
2785440|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||kW||Standard Deviation|Mean
2785441|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||kilowatt (kW)||Standard Deviation|Mean
2785442|NCT00625872|Secondary|Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18|Vmax was measured by Leonardo Jumping Platform during one leg jump.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||m/s||Standard Deviation|Mean
2785443|NCT00625872|Secondary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during one leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Newtons||Standard Deviation|Mean
2785444|NCT00625872|Secondary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during one leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||W/kg||Standard Deviation|Mean
2785445|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18|CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Units on a scale||Standard Deviation|Mean
2785446|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Units on a scale||Standard Deviation|Mean
2785447|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Units on a scale||Standard Deviation|Mean
2785448|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Seconds||Standard Deviation|Mean
2785460|NCT00625846|Other Pre-specified|Change in Blood Markers for Angiogenesis|Blood markers for angiogenesis including levels of free VEGF, free GW786034, and GW786034/VEGF complexes will be evaluated before and during therapy. Changes in these levels will largely be explored in a graphical manner as well as exploring any potential relationships between these levels and clinical outcome such as response or progression-free rate and toxicity incidence.|Baseline to up to 3 years|||||||
2788326|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42||Days 42|mITT dataset|||Percentage of lesions|Participants|95% Confidence Interval|Number
2785449|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure and 'n' signifies participants who received the study drug and evaluated at the time point for each group respectively.|||Seconds||Standard Deviation|Mean
2785450|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.|||Units on a scale||Standard Deviation|Mean
2785451|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2785452|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Newtons||Standard Error|Least Squares Mean
2785453|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.|||W/kg||Standard Error|Least Squares Mean
2785454|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.|||Watt/kilogram (W/kg)||Standard Error|Least Squares Mean
2785455|NCT00625846|Other Pre-specified|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by >= 50% of previously involved sites from nadir). Duration of response will be assessed.|Time from registration to the date the patient discontinues treatment, assessed up to 3 years|||||||
2785456|NCT00625846|Other Pre-specified|Time to Subsequent Therapy|Estimated using the method of Kaplan-Meier.|Up to 3 years|||||||
2785457|NCT00625846|Other Pre-specified|Time to Treatment Failure|Estimated using the method of Kaplan-Meier.|Time from registration to the date the patient discontinues treatment, assessed up to 3 years|||||||
2785458|NCT00625846|Other Pre-specified|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median is estimated using the Kaplan-Meier estimator. > Estimated using the method of Kaplan-Meier.|Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years|||||||
2785459|NCT00625846|Other Pre-specified|Proportion of Patients With Differentiated Thyroid Cancer and Medullary Thyroid Cancer Who Have Not Failed Treatment at 6 Months (3 Months for Anaplastic Thyroid Cancer)|The proportion of patients who have not failed treatment due to disease progression, adverse reactions, refusal for further participation, or who went on to alternate therapy at 6 months (3 months for anaplastic thyroid cancer patients) will be calculated and summarized independently within each of the patient groups. Assuming that the incidence of response is binomially distributed, 90% binomial confidence intervals will also be calculated.|Up to 6 months|||||||
2785461|NCT00625846|Secondary|Progression-Free Survival at 3 Months (Cohort 3 Only)|Progression free survival at 3 months (PFS6) is defined as the proportion of patients alive and without progression at 3 months. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 months|All patients from Cohort 3 that were treated and evaluable for response were included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2785462|NCT00625846|Secondary|Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only)|Progression free survival at 6 months (PFS6) is defined as the proportion of patients alive and without progression at 6 months. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 6 months|All patients in Cohort 1 and Cohort 2 that received treatment and were eligible for response assessment were included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2785463|NCT00625846|Secondary|Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment|Toxicity (defined as grade 3+ adverse events deemed possibly, probably, or definitely related to treatment) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The percentage of patients with grade 3+ adverse events deemed possibly, probably, or definitely related to treatment are reported for patients in Cohorts 1-3.|Up to 3 years|All patients that received protocol treatment and were assessed for adverse events are included in this analysis.|||percentage of participants|||Number
2785464|NCT00625846|Primary|Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort)|The confirmed tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients with differentiated thyroid cancer who are thyroglobulin antibody negative. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|All patients that registered to the Differential Thyroid Expansion cohort and were evaluable for response assessment were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2785465|NCT00625846|Primary|Overall Response Rate (in Cohorts 1-3)|The tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients in Cohorts 1-3. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|All patients in Cohort 1, Cohort 2, and Cohort 3 that received treatment and were eligible for response assessment were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2785466|NCT00625820|Secondary|Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy.||12 weeks||||ml/min/1.73m2||Standard Deviation|Mean
2785467|NCT00625820|Secondary|Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy.||12 weeks||||mmHG||Standard Deviation|Mean
2785468|NCT00625820|Primary|The Primary Outcome Measure is Level of Albuminuria.|Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.|12 weeks|All participants who finished the trial were analyzed|||ratio||Standard Deviation|Mean
2785469|NCT00625807|Secondary|Self Compassion|This scale assesses one's ability to be forgiving and kind to oneself in difficult circumstances. Scores range from 1-5. Higher scores mean more self compassion.|Pre, week 8|individuals who completed the measure at week 8|||units on a scale||Standard Deviation|Mean
2785470|NCT00625807|Primary|Anxiety Severity Index|the Anxiety Sensitivity Index (ASI) is a measure of individuals discomfort with a variety of sensations associated with anxiety and panic and tends to be substantially higher in those with panic disorder (and attacks) than in those with General Anxiety Disorder. Scores range from 0 - 64. Lower scores mean lower anxiety.|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
2785471|NCT00625807|Primary|Penn State Worry Questionnaire|The Penn State Worry Questionnaire (PSWQ) is a standard self-report questionnaire that is designed to assess symptoms of General Anxiety Disorder. scores range from 16-80 with higher scores meaning more stress.|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
2785472|NCT00625807|Primary|Perceived Stress Scale|The PSS is brief, validated and widely used psychological instrument for assessing a subject's perception of stress change. Scores range from 0-40 with higher scores meaning more stress|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
2785473|NCT00625807|Primary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness in community samples. Scores range from 39-195 with higher scores meaning more mindfulness.|Pre, 8 weeks|Individuals who completed at least one measure at post|||units on a scale||Standard Deviation|Mean
2785474|NCT00625807|Primary|Brain Activity (fMRI) During the Body Scan Meditation|Seed based functional connectivity analysis was performed using the Connectivity Toolbox (CONN) implemented within the Statistical Parametric Mapping program (SPM8; Welcome Department of Cognitive Neurology). Our seeds were located in the right inferior frontal gyrus pars opercularis (MNI coordinates: 54, 14, 16) and the dorsal anterior insula (MNI coordinates: 32, 20, 0). Note - MRI data from some subjects was either missing, not collected, or corrupted, and so the analyses were performed on just the subject of subjects who had complete datasets. This assessment reflects the total number of voxels per group.|Week 8||||voxels|||Number
2785475|NCT00625742|Secondary|Improvement of Clinical Outcomes|Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.||||||
2785476|NCT00625742|Primary|Participant Gain in Lean Body Mass|Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.||||||
2785477|NCT00625729|Secondary|Number of Patients With Overall Survival|Number of patients alive at 6 months after treatment.|6 Months||||Participants|||Number
2785478|NCT00625729|Secondary|Number of Patients With Adequate Natural Killer Cells Infused|Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg).|Day 0||||Participants|||Number
2785479|NCT00625729|Secondary|Number of Patients Whose Disease Progressed After Treatment|Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment.|6 Months|Only patients who responded to treatment included in the analysis.|||Participants|||Number
2785480|NCT00625729|Secondary|Number of Patients With Overall Response|Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia|3 Months||||Participants|||Number
2785481|NCT00625729|Secondary|Number of Patients With Interleukin-15 Production and NK Cell Expansion|Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion|Day 0|Correlation of interleukin-15 with Natural Killer Cell expansion cannot be calculated because there was no Natural Killer Cell expansion.|||Participants|||Number
2785482|NCT00625729|Primary|Number of Patients Exhibiting Natural Killer Cell Expansion|Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.|Day 14||||Participants|||Number
2785483|NCT00625703|Secondary|Pulmonary Exacerbations With Methicillin Resistant Staphylococcus Aureus (MRSA) to Treatment With Linezolid|to characterize the clinical response of children with pulmonary exacerbations (increase in the severity of the patient's lung symptoms) associated with methicillin resistant Staphylococcus aureus (MRSA) to treatment with linezolid|2 months|No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful||||||
2785484|NCT00625703|Primary|To Determine the Pharmacokinetic Profile of IV (Intravenous) and PO (Oral) Formulations of Linezolid Among Children With Cystic Fibrosis|To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.|2 months|No data are available as PI is no longer at the institution. Several attempts were made to locate the PI or other study personnel associated with this study, but they were unsuccessful||||||
2785485|NCT00625586|Primary|Proportion of Patients Alive at 8 Months||8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
2785486|NCT00625586|Secondary|Cmax|RAV12 and gemcitabine cmax|29 days|||||||
2785487|NCT00625586|Secondary|Adverse Events|Frequency of adverse events and serious adverse events|any timeframe following study drug up to 3 years|||||||
2785488|NCT00625586|Secondary|Overall Survival||three years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
2785489|NCT00625586|Secondary|Progression-free Survival||time to progression or death, up to 3 years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
2785490|NCT00625586|Secondary|Partial Response and Complete Response Rates|Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated.|8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.||||||
2785491|NCT00625586|Secondary|Proportion of Patients Alive at 12 Months||12 months|||||||
2785492|NCT00625443|Secondary|Number of Participants With Changes in Concomitant Steroid Use|A participant who used steroids at study entry was considered to have permanently discontinued steroid use if they had no steroid use during the last 8 weeks of the study Treatment Period. A participant who used steroids at study entry was considered to have decreased concomitant steroid medication by at least 50% if they permanently discontinued steroids, or in no dose of steroid was higher than 50% of their baseline steroid dose during the last 8 weeks of the study Treatment Period.|Day 1 through last 8 weeks of the Treatment Period|FAS. Data was summarized using the OC method. Only those participants who had data available at both Baseline and post-Baseline were analyzed.|||Number of participants|||Number
2785493|NCT00625443|Secondary|Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
2785768|NCT00623623|Secondary|Number of Patients With Serious Repeat Target Vessel Revascularization|This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785494|NCT00625443|Secondary|Percentage of Participants Who Maintained Response-Level Platelet Count|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
2785495|NCT00625443|Secondary|Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
2785496|NCT00625443|Secondary|Percentage of Participants Who Maintained a Platelet Count of 100,000/mm^3 or Higher by Response Status|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
2785497|NCT00625443|Secondary|Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm^3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|FAS. Data was summarized using the OC method.|||Percentage of participants|||Number
2785498|NCT00625443|Secondary|Median Platelet Counts at Selected Analysis Timepoints|"Platelet count (PC) was measured from blood draws. Based on avatrombopag response in study 501-CL-003, participants were divided into two subgroups; 1) Responders, participants who met the primary efficacy response; pretreatment PC was less than 30,000/mm^3 and increased to greater than or equal to 50,000/mm^3 after treatment with avatrombopag, and for participants on steroids, pretreatment PC was greater than or equal to 30,000/mm3 but less than 50,000/mm^3 and increased to a PC greater than or equal to 20,000/mm^3 above their pretreatment values and 2) Nonresponders, participants who did not meet the primary efficacy response and those who were in the placebo arm. Open-label dose escalation of avatrombopag, as well as reductions in ITP-directed concomitant therapy (e.g. steroids) was allowed for all participants. During the periods of avatrombopag dose escalation and/or ITP-directed concomitant medication reduction, platelet sampling was done weekly."|Day 1, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4|Full analysis set (FAS) included all participants who completed 501-CL-003 and received study drug in the current study, except baseline values and ITP-directed medications taken during the 2-week period before the first dose of avatrombopag in the current study. Data was summarized using the observed case (OC) method.|||Platelets x 1000/mm^3||Full Range|Median
2785511|NCT00625404|Primary|Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration|The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.|10-26 months per site|The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.|||Number of adverse events|||Number
2785769|NCT00623623|Secondary|Number of Patients With Rehospitalisation for Non-cardiac Reasons|This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785499|NCT00625443|Primary|Incidence of Drug-Related TEAEs|Drug-related TEAEs included those whose relationship was categorized as possible or probably by the investigator. A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).|Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.|"Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term post-treatment refers to any assessment timepoint after the participant received at least one dose of study drug."|||Participants|||Count of Participants
2785500|NCT00625443|Primary|Incidence of Severe (Grade 3 or 4) TEAEs|A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).|Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.|"Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term post-treatment refers to any assessment timepoint after the participant received at least one dose of study drug."|||Participants|||Count of Participants
2785501|NCT00625443|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of study drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. Related AEs included those whose relationship was categorized as possible or probably by the investigator. Dose interruption includes dose decreased, dose previously stopped, permanently stopped, or temporarily stopped. The safety population was divided into three subgroups based on the mean daily dose of active study drug taken; lower 1/3 (less than 8.85 mg avatrombopag), middle 1/3 (greater than or equal to 8.85 mg but less than 13.5 mg avatrombopag), and upper 1/3 (greater than or equal to 13.5 mg avatrombopag).|Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.|"Safety population included all participants who received at least one dose of study drug and had at least one post-treatment safety assessment. The term post-treatment refers to any assessment timepoint after the participant received at least one dose of study drug."|||Participants|||Count of Participants
2785502|NCT00625404|Secondary|Participant Report of Change in Number of Sexual Partners|Difference in mean number of reported sexual partners between final study visit and enrollment visit|Up to 52 weeks|Women reporting on sexual behavior during follow-up|||mean number of sexual partners||Standard Deviation|Mean
2785503|NCT00625404|Secondary|Pill Counts and Participant Report of Adherence to Once-daily Pill Taking|Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts|Up to 52 weeks|All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment|||percentage of days||Standard Deviation|Mean
2785504|NCT00625404|Secondary|Pregnancy Complications|Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications|up to 60 weeks|Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)|||participants|||Number
2785505|NCT00625404|Secondary|FTC and/or Tenofovir Resistance|"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time."|up to 52 weeks|All women who seroconverted were assessed for possible resistance.|||participants|||Number
2785506|NCT00625404|Secondary|CD4+ T-cell Count|CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks|Up to 16 weeks||||cells/mL||Standard Deviation|Mean
2785507|NCT00625404|Secondary|Plasma HIV RNA Level (HIV-1 Viral Load)|Viral load at the time of HIV detection, HIV conversion and through 16 weeks|up to 16 weeks|68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit|||log copies/mL||Standard Deviation|Log Mean
2785508|NCT00625404|Primary|Confirmed Grade 3 or Higher AST Elevation|Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product||||participants|||Number
2785509|NCT00625404|Primary|Confirmed Grade 3 or Higher ALT Elevation|Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product||||participants|||Number
2785510|NCT00625404|Primary|Confirmed Grade 3 or Higher Reduction in Phosphorus|Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL|Through 52 weeks on product and 4 weeks post-product||||participants|||Number
2785770|NCT00623623|Secondary|Number of Patients With Rehospitalisation for Cardiac Reasons|This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2802659|NCT00508027|Other Pre-specified|Change in Plasma IL-6 Levels|Change in plasma IL-6 level after treatment with simvastatin|Baseline, 21 days||||pg/mL||Standard Deviation|Mean
2785512|NCT00625404|Primary|Confirmed Grade 2 or Higher Serum Creatinine Toxicity|Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal|cumulative toxicity through 52 weeks of product use and 4 weeks post product|The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.|||participants|||Number
2785513|NCT00625404|Primary|HIV Infection|HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.|Cumulative HIV infection between enrollment and 52 weeks|All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population|||participants|||Number
2785514|NCT00625391|Secondary|Oxidative Stress Damage Biomarker|Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test|24 weeks|Analyzed who completed the study.|||ng/mg creatinine||Standard Deviation|Mean
2785515|NCT00625391|Primary|Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker|Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)|24 weeks|Analyzed on those who completed the study. Percent change relative to the baseline for each group.|||percentage change from baseline||Standard Deviation|Mean
2785516|NCT00625365|Secondary|Adverse Events|Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration|Through 24 hours||||Participants|||Number
2785517|NCT00625365|Secondary|Serious Adverse Events|Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration|Through 24 hours||||Participants|||Number
2785518|NCT00625365|Primary|The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration||during or within 30 minutes of administration|The safety population was analyzed per the protocol|||Participants|||Number
2785519|NCT00625183|Secondary|Distant Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment.||||||
2785520|NCT00625183|Secondary|Local Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.||||||
2785521|NCT00625183|Secondary|Dose Intensity||During treatment with capecitabine, oxaliplatin, selenomethionine.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.||||||
2785522|NCT00625183|Secondary|Safety and Tolerability as Assessed by NCI CTCAE Version 3.0|Number of participants with any adverse event as assessed by NCI CTCAE version 3.0.|Adverse events were queried for and collected every cycle for the duration of treatment.|All treated and eligible patients|||Participants|||Count of Participants
2785523|NCT00625183|Primary|Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was collected for this assessment.||||||
2785524|NCT00625183|Primary|Complete Pathological Response Rate||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no data was not collected for this assessment.||||||
2785525|NCT00625131|Secondary|Smoking Craving|"Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item Please rate your desire to smoke right now with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is worse, as lower craving is presumed to reflect decreased risk of smoking lapse or relapse."|Daily between visits 2-12||||units on a scale||Standard Deviation|Mean
2785526|NCT00625131|Secondary|Carbon Monoxide Monitoring|Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)|Session 12 (6 weeks post-treatment)|Please note that this secondary outcome (bioverification by CO reading) is not a measure of complete smoking abstinence during the study period (or during the week prior to the session - see Primary Outcome). It is independent of self-reported smoking abstinence. It is not unexpected that CO readings different than self-reported smoking.|||participants|||Number
2785527|NCT00625131|Primary|Smoking Abstinence, Self-reported|Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment|Week prior to Session 12 at 6 weeks post-treatment|Any participants who did not attend Session 12 for any reason (i.e., lost to contact, withdrawn after beginning treatment) were counted as smoking (i.e., intent-to-treat analyses, missing = smoking).|||participants|||Number
2785528|NCT00624923|Secondary|Change in Inflammation in the Liver Associated With Nonalcoholic Steatohepatitis (NASH), ALT|Secondary outcome, change in liver inflammation associated with NASH: ALT|baseline to 30 mo||||U/L||95% Confidence Interval|Mean
2785529|NCT00624923|Secondary|Change in Inflammation Marker: CRP|Secondary outcome of change in inflammation marker CRP|baseline to 30 mo||||mg/L||95% Confidence Interval|Mean
2785530|NCT00624923|Secondary|Change in Cholesterol|secondary|Baseline to 30 mo||||mg/dL||95% Confidence Interval|Mean
2785531|NCT00624923|Primary|Change in Non-calcified Plaque Volume in the Coronary Arteries Assessed by MDCTA From Baseline to 30 Months||Baseline to 30 months|Intention to Treat|||mm^3||95% Confidence Interval|Mean
2785690|NCT00624052|Secondary|Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in SBP in this study|Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
2785532|NCT00624832|Secondary|Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the best post saline (Control) FEV1 was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0)."|Week 0, Week 8 and Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.|||Percentage of LAR||Standard Deviation|Mean
2785533|NCT00624832|Primary|Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge:~EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the best post saline (Control) FEV1 was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate."|Week 8, Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.|||Percentage of EAR||Standard Error|Least Squares Mean
2785534|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Participants|||Count of Participants
2785535|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Participants|||Count of Participants
2785536|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Participants|||Count of Participants
2785537|NCT00624819|Secondary|Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)]|A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Participants|||Count of Participants
2785538|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|A seropositive subject was a subject whose anti-PD antibody concentration was greater than or equal to (≥) the cut-off value. The seropositivity cut-off for the assay was 100 EL.U/ML.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Participants|||Count of Participants
2785539|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Participants|||Count of Participants
2788190|NCT00607672|Secondary|Re-exploration for Bleeding|The percentage of patients that were taken back to the operating room for re-exploration because of bleeding|From arrival in intensive care unit until discharge from hospital||||percentage of patients|||Number
2785540|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic Activity (OPA). The seropositivity cut-off for the assay was 8.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Participants|||Count of Participants
2785541|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Participants|||Count of Participants
2785542|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were mesured by Opsonophagocytic activity (OPA). The seropositivity cut-off for the assay was 8.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Participants|||Count of Participants
2785543|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Participants|||Count of Participants
2785544|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Participants|||Count of Participants
2785545|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The immune responses were measured by 22F-inhibation ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Participants|||Count of Participants
2785546|NCT00624819|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 6A and 19A. The results for the immune responses were measured by 22F-inhibition ELISA. The seropositivity cut-off for the assay was 0.05 μg/mL.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Participants|||Count of Participants
2785562|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)|The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 Study for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Titers||95% Confidence Interval|Geometric Mean
2785547|NCT00624819|Secondary|Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Analysis was performed with Unprimed group included. The seropositivity cut-off for the assay was 8.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Participants|||Count of Participants
2785548|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Participants|||Count of Participants
2785549|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Participants|||Count of Participants
2785550|NCT00624819|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The seropositivity cut-off for the assay was 8.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Participants|||Count of Participants
2785551|NCT00624819|Secondary|Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)]|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity."|For primed groups: from Months 48-49 (additional vaccination period); for unprimed group: from Day 0 up to Month 3 (catch-up vaccination period)|The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects in study 111347. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2785552|NCT00624819|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)]|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity."|From Year (Y) 2 to Y4 FU visit (post booster vaccination administered in 10PN-PD-DIT-007) i.e. for each subject(S): when S was enrolled in 111346 study until S completed the same study visit or the 111347 study visit (range of 1 to 3 years for each S))|The analysis was performed on the Total enrolled cohort which included all primed subjects from Y2 follow-up sub-study 111346 and from Y4 long-term follow-up sub-study 111347 for antibody persistence for whom data concerning antibody persistence were available.|||Participants|||Count of Participants
2785553|NCT00624819|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)]|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any was defined an incidence of a SAE regardless of intensity/severity."|During Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007) i.e. for each primed subject: from the time the subject was enrolled in the 111345 study until he/she completed the same study (approximatively 12 months)|The analysis was performed on the primed subjects who were enrolled in the applicable 111345 Year 1 Follow-Up Study.|||Participants|||Count of Participants
2785554|NCT00624819|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Follow-up period was of 31 days (Days 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 31 days for primed subjects and 2 periods of 31 days for unprimed subjects."|Within 31 days (Day 0-30) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study|The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2785555|NCT00624819|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (any fever defined as temperature by axillary measurement of 37.5°C and above). Grade 3 drowsiness was defined as drowsiness that prevented normal activity; Grade 3 irritability was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as subject not eating at all. Grade 3 fever was defined as axillary temperature >39.5°C. Related AE was defined as any AE assessed by investigators to be causally related to administration of the study vaccine. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects.|Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study|The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2785556|NCT00624819|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (>) 0 millimeter (mm). Grade 3 pain = maximum intensity of local injection defined as subject crying when limb was moved/spontaneously painful. Grade 3 redness/swelling= maximum intensity of local injection >30 mm. Follow-up period was of 4 days (Days 0-3) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study, thus one period of 4 days for primed subjects and 2 periods of 4 days for unprimed subjects.|Within 4 days (Days 0-3) period(s) after Synflorix vaccination in Year 4 Persistence and Immunological Memory 111347 Study|The analyses were performed on the Total Vaccinated Cohort (TVC) which included all vaccinated subjects. The TVC for analysis of safety included all primed subjects with additional vaccine dose administration documented and all unprimed subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
2785557|NCT00624819|Secondary|Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785558|NCT00624819|Secondary|Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT- 007)|The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 study for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785559|NCT00624819|Secondary|Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT- 007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785560|NCT00624819|Secondary|Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2785561|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Titers||95% Confidence Interval|Geometric Mean
2785704|NCT00623831|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 3 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
2785563|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Titers||95% Confidence Interval|Geometric Mean
2785564|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|Opsonophagocytic activity were assessed for pneumococcal serotypes 6A and 19A (OPA-6A and OPA-19A). The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Titers||95% Confidence Interval|Geometric Mean
2785565|NCT00624819|Secondary|Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||μg/mL||95% Confidence Interval|Geometric Mean
2785566|NCT00624819|Secondary|Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.|At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT- 007)|The analysis was a persistence analysis performed on the evaluable subjects enrolled in the applicable Year 4 Persistence and Immunological Memory 111347 Study, for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||μg/mL||95% Confidence Interval|Geometric Mean
2785567|NCT00624819|Secondary|Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)|The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL).|At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PDDIT- 007)|The analysis was performed on the ATP cohort for persistence, which included all subjects from the total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results were available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||μg/mL||95% Confidence Interval|Geometric Mean
2785568|NCT00624819|Secondary|Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|The seropositivity cut-off for the assay was ≥ 0.05 μg/mL. Antibody concentrations against 6A and 19A pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micrograms per milliliter (µg/mL).|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||μg/mL||95% Confidence Interval|Geometric Mean
2785569|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||Titers||95% Confidence Interval|Geometric Mean
2785570|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|Pneumococcal serotypes assessed were pneumococcal serotypes OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|At Year 4 (Y4) (post booster vaccination administrated in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Titer||95% Confidence Interval|Geometric Mean
2788191|NCT00607672|Secondary|Blood Loss|Blood loss over 24 hours as measured by chest tube output|First 24 hours after arrival in the intensive care unit||||mL||Standard Error|Mean
2785571|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|At Year 2 (Y2) (post booster vaccination administrated in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Titer||95% Confidence Interval|Geometric Mean
2785572|NCT00624819|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|Pneumococcal serotypes assessed were OPA-1, OPA-4, OPA-5, OPA-6B, OPA-7F, OPA-9V, OPA-14, OPA-18C, OPA-19F and OPA-23F. The seropositivity cut-off for the assay was ≥ 8. Opsonophagocytic activity was expressed as Geometric Mean Antibody Titers (GMT).|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Titer||95% Confidence Interval|Geometric Mean
2785573|NCT00624819|Secondary|Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)]|Anti-pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F . Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.|For primed groups: At Month 48+7 days after additional dose (D7);For unprimed group: at Day 0 (D0) (Pre-vaccination [PRE]), at Day 7 (D7) post dose 1 (of the 2-dose catch-up vaccination) and at Month 3 (M3) post dose 2 (of the 2-dose catch-up vaccination)|The ATP cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one vaccine antigen component for blood samples taken 7 days after additional dose (primed subjects) or at pre-vaccination, 7 days post-dose 1, and 1-month post-dose 2 catch-up vaccination (unprimed subjects).|||μg/mL||95% Confidence Interval|Geometric Mean
2785574|NCT00624819|Secondary|Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|Pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PDDIT- 007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||μg/mL||95% Confidence Interval|Geometric Mean
2785575|NCT00624819|Secondary|Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
2785576|NCT00624819|Secondary|Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|Pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Antibody concentrations against pneumococcal serotypes were determined as Geometric Mean Antibody Concentrations (GMC) and expressed as micro grams per milliliter (µg/mL).The seropositivity cut-off for the assay was ≥ 0.05 µg/mL.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||µg/mL||95% Confidence Interval|Geometric Mean
2785577|NCT00624819|Primary|Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.|At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 4.|||Participants|||Count of Participants
2785578|NCT00624819|Primary|Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.|At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)|The ATP cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 2.|||Participants|||Count of Participants
2785705|NCT00623805|Secondary|Percentage of Participants With a R0 Resection|An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|Baseline to the end of the study (up to 4 years, 2 months)|||||||
2785579|NCT00624819|Primary|Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]|A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.|At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)|The According-To-Protocol (ATP) cohort for persistence included all primed subjects from the Total enrolled cohort who had not received a vaccine or product forbidden in the protocol and for whom assay results available for the antibodies against at least one vaccine antigen component for the blood sampling taken at Year 1.|||Participants|||Count of Participants
2785580|NCT00624806|Primary|Percent of Participant Triggering DMP Items|Percent of participants who triggered Disease-Management Protocol items by group.|Enrollment to study end, 8 weeks||||% of participants triggering an item|Participants||Number
2785581|NCT00624806|Primary|Number of Days With Triggers at Certain Timeframe|Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.|Enrollment to study end, 8 weeks||||days|Participants||Number
2785582|NCT00624806|Primary|Days of Data|Data includes the number of triggered items and types of triggers.|Enrollment to study end, 8 weeks||||days||Full Range|Mean
2785583|NCT00624780|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)|Safety analysis set: all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure during each specified period, for each group respectively.|||participants|||Number
2785584|NCT00624780|Other Pre-specified|Sheehan-Suicidality Tracking Scale (S-STS) Score|Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency.|Baseline up to Week 24|Data was not statistically summarized but was available in individual participant listings and mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) due to change in planned analysis.||||||
2785585|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785586|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785587|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785588|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785589|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 2|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785590|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 1|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785591|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2788476|NCT00605319|Primary|Average Flow Rate (Qavg)|Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time|screening (Month 0), 2-months, 3-months, 7-months||||mL/s||Standard Deviation|Mean
2785592|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785593|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785594|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Last observation carried forward (LOCF) method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2785595|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785596|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785597|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785598|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N(Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785599|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785600|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785601|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785602|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785603|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785604|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’=participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785605|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785606|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785607|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.|||participants|||Number
2785608|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 1: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.|||participants|||Number
2785609|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis.|||participants|||Number
2785610|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2785771|NCT00623623|Secondary|Number of Patients With Recurrent Myocardial Infarction (Reinfarction)|This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785611|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2785612|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2785613|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785614|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785615|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785616|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785617|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785618|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2785641|NCT00624520|Secondary|State Anger|Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
2785619|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785620|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.|||units on a scale||Standard Deviation|Mean
2785621|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785622|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.|||units on a scale||Standard Deviation|Mean
2785623|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2785624|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group.|||units on a scale||Standard Deviation|Mean
2785625|NCT00624650|Primary|The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water||The first seven days of treatment|The study's Principal Investigator departed the institution before analyses were conducted. OHSU will never have analyses complete for this study. The study device is no longer manufactured.||||||
2785626|NCT00624585|Secondary|Number of Participants With Stable Disease (SD)||1 Year 4 Months|All Participants|||participants|||Number
2785627|NCT00624585|Secondary|Number of Participants With Partial Remission (PR)|Partial remission (PR) (modified IWG); IWG = International MDS Working Group. All of the CR criteria (if abnormal prior to treatment), except: Bone marrow evaluation: Blasts decreased by ≥ 50% over pretreatment but still >5%. Cellularity and morphology are not relevant.|1 Year 4 Months|All Participants|||participants|||Number
2785628|NCT00624585|Secondary|Number of Participants With Hematologic Improvement|Hematologic improvement in platelets, red blood cell (RBC), neutrophils according to modified IWG Criteria; Cytogenetic response (modified IWG); Change in percentage of blasts in bone marrow and peripheral blood; Src-Tyr416 phosphorylation in medullary myeloblasts. Hematologic improvements must last ≥ 8 weeks.|1 Year 4 Months|All Participants|||participants|||Number
2785629|NCT00624585|Primary|Number of Participants With Marrow Complete Remission (CR)|"Complete remission (modified IWG); IWG = International MDS Working Group.~Bone Marrow Response must last ≥4 weeks. Bone marrow evaluation: Bone marrow showing ≤5% myeloblasts with normal maturation of all cell lines."|1 Year 4 Months|All Participants|||participants|||Number
2785630|NCT00624559|Secondary|Urinary Sodium Excretion|Urine collected over 24 hour period on last day of each different sodium diet|24 hour||||mmol Na+/24 hr||Standard Error|Mean
2785631|NCT00624559|Primary|Mean Arterial Pressure|Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor|24 hours||||mm Hg||Standard Error|Mean
2785685|NCT00624052|Secondary|Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|up to 34 weeks|Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment|||patients|||Number
2785632|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Anger-recall Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect"|Immediate to 6 months post intervention|Response to Mental Stress by Anger-Recall Stress Task|||mmHg x beats/minute||Standard Error|Mean
2785633|NCT00624520|Primary|Mental Stress Induced Elevation in Double Product by Math Stress Task|"Maximum Mental Stress induced elevation in Double Product , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|3 months post intervention|Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention.|||mmHg x beats/minute||Standard Error|Mean
2785634|NCT00624520|Secondary|Cardioverter-DefibrillatorTherapies|Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia|6 months post intervention|Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention|||percentage of participants|||Number
2785635|NCT00624520|Secondary|Low Frequency/High Frequency Ratio of Heart Rate Variability|Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|"Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data.~Data are shown for Ratios of Low and High Frequency power shown above."|||Ratio||Standard Deviation|Mean
2785636|NCT00624520|Secondary|High Frequency Heart Rate Variability|Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data.|||percentage of spectral power||Standard Deviation|Mean
2785637|NCT00624520|Secondary|Low Frequency Heart Rate Variability|"Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.~Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power."|6 months post intervention|6 months post intervention, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data.|||percentage of spectral power||Standard Deviation|Mean
2785638|NCT00624520|Secondary|Depression/Dejection|Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..|3 months post intervention|3 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
2785639|NCT00624520|Secondary|Perceived Stress|Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
2785640|NCT00624520|Secondary|Tension/Anxiety|Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.|||units on a scale||Standard Deviation|Mean
2785686|NCT00624052|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|up to 34 weeks|The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment|||Days||Standard Deviation|Mean
2785642|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Math Stress Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|Immediate to 6 months post intervention|Response to Mental Stress by Math Stress Task.|||mmHg x beats/min||Standard Error|Mean
2785643|NCT00624468|Secondary|Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack|Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature [axillary, orally or intraauricularly] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.|From baseline (Study Day 1) up to Week 36|ITT population included all randomized participants.|||percentage of participants|||Number
2785644|NCT00624468|Secondary|Contrast Sensitivity: Score Line|Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||units on a scale||Standard Deviation|Mean
2785645|NCT00624468|Secondary|Contrast Sensitivity: Total Number of Letters Correctly Identified|Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||letters||Standard Deviation|Mean
2785646|NCT00624468|Secondary|Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified|Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||letters||Standard Deviation|Mean
2785647|NCT00624468|Secondary|Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36|The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||cubic micrometer||Standard Deviation|Mean
2785648|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
2785649|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
2785650|NCT00624468|Secondary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.|Baseline, Weeks 12 and 24|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
2785687|NCT00624052|Secondary|Trough BP Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)||||patients|||Number
2785772|NCT00623623|Secondary|Number of Patients With Congestive Heart Failure (CHF)|This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported.|30 days|FAS|||Participants|||Count of Participants
2785651|NCT00624468|Secondary|Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Error|Mean
2785652|NCT00624468|Primary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.|Baseline, LOV (Week 48)|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."|||micrometer||Standard Deviation|Mean
2785653|NCT00624442|Secondary|Pharmacokinetics of CK-1827452 Injection in Stable Heart Failure Patients||2 days|||||||
2785654|NCT00624442|Primary|Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.|||Percentage of change||Standard Error|Least Squares Mean
2785655|NCT00624442|Primary|Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.|||msec||Standard Error|Least Squares Mean
2785656|NCT00624416|Secondary|The Number of Subjects Elected to Have the Lipoma Removed.||After four weeks up to one year.||||participants|Participants||Number
2785657|NCT00624416|Secondary|The Number of Lipoma Increased in Volume.||After four weeks of treatment up to one year.||||Lipomas|Participants||Number
2785658|NCT00624416|Primary|The Average Percent Volume Reduction in the Lipoma.||Baseline and 4 weeks||||Percent Volume reduction (cc^3)|Participants|Full Range|Mean
2785659|NCT00624377|Secondary|Percentage of Participants Which Had a Reduction of Concomitant Drug Use|The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.|8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Percentage of Participants|||Number
2785660|NCT00624377|Secondary|Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
2785661|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
2785662|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
2785688|NCT00624052|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
2785773|NCT00623623|Secondary|Number of Patients With Cardiogenic Shock|This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported.|30 days|FAS|||Participants|||Count of Participants
2785663|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
2785664|NCT00624377|Primary|Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment|FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (<80%, often ~45%).|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Ratio||Standard Deviation|Mean
2785665|NCT00624377|Primary|Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment|FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||liter per second||Standard Deviation|Mean
2785666|NCT00624377|Primary|Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."|||Units on a Scale||Standard Deviation|Mean
2785667|NCT00624338|Secondary|Mean Cumulative Corticosteroid Dose||Randomization up to Week 52|MITT population included all the randomized participants who received study treatment.|||mg||Standard Deviation|Mean
2785668|NCT00624338|Secondary|Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares|"Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|Week 52|MITT population included all the randomized participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2785669|NCT00624338|Secondary|Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks|"A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|From screening up to Week 24|MITT population included all the randomized participants who received study treatment.|||percentage of participants|||Number
2785670|NCT00624338|Secondary|Time to First New Flare as Defined by BILAG Score A or B|"A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|From screening up to Week 52|MITT population included all the randomized participants who received study treatment|||days||95% Confidence Interval|Number
2785689|NCT00624052|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
2785706|NCT00623805|Secondary|Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery||Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Percentage of participants|||Number
2785671|NCT00624338|Primary|Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B|"A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|From screening up to Week 52|Modified intent-to-treat (MITT) population included all the randomized participants who received study treatment.|||percentage of participants|||Number
2785672|NCT00624286|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug. FEV1 data taken within 6 h of rescue medication was excluded from this analysis.|||Liters||Standard Error|Least Squares Mean
2785673|NCT00624286|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2785674|NCT00624234|Secondary|Neuroimaging Data|Neuroimaging data consists of functional MRI and structural MRI measures.|Collected before and after intervention||2019-10-31|10/2019||||
2785675|NCT00624234|Primary|Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours|This metric measures change in reading abilities, including word recognition and decoding, as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery - 3rd Edition Normative Update; WJ-III NU). The scores are reported as change in age-normed standard scores (a change of 15 standard score points would represent a change of 1 standard deviation in the general population).The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.|0 and 15 hours||||units on a scale||Standard Deviation|Mean
2785676|NCT00624221|Secondary|Graft Dislocation||1 day to 1 month after grafting|||||||
2785677|NCT00624221|Secondary|Best Corrected Vision||6 months and 1 year after grafting|||||||
2785678|NCT00624221|Primary|Endothelial Cell Loss|Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.|6 months after grafting||||percentage of endothelial cell loss||Standard Deviation|Mean
2785679|NCT00624195|Primary|Neuropsychological Performance Change|The outcome measure is change in performance from baseline to 16 weeks as measured by the global deficit score (GDS). The GDS is calculated by averaging the individual deficit scores from each neurocognitive test. Deficit scores for each test were calculated from age-, education-, gender-, and ethnicity-adjusted raw scores by methods that capture unexpectedly poor performance while ignoring better than expected performance. The GDS ranges in value from 0-5; higher scores indicate poorer cognitive functioning. Subjects with scores greater than or equal to 0.5 are considered cognitively impaired.|Baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
2785680|NCT00624065|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6|Mean change was calculated as Week 6 values minus Baseline values.|Baseline and Week 6|ITTE|||mmHg||Standard Deviation|Mean
2785681|NCT00624065|Primary|Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment|Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.|Week 6|Intent to Treat Efficacy (ITTE) Population: all randomized participants with efficacy (vital signs) data after a minimum of 4 weeks of treatment|||Participants|||Number
2785682|NCT00624052|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.|up to 34 weeks|91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.|||patients|||Number
2785683|NCT00624052|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set|||mmHg||Standard Deviation|Mean
2785684|NCT00624052|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment|||mmHg||Standard Deviation|Mean
2785774|NCT00623623|Secondary|Number of Patients With Cardiac Mortality|This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported.|30 days|FAS|||Participants|||Count of Participants
2785691|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
2785692|NCT00624052|Secondary|Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in DBP in this study|Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
2785693|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
2785694|NCT00624052|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reached the target SBP of >=140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
2785695|NCT00624052|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reached the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||patients|||Number
2785696|NCT00624013|Secondary|Quality of Life|Quality of life (QOL) was assed at baseline and at month 6 using validated instrument Diabetes-39 Quality of Life Questionnaire. It consists of 39-item questionnaire designed to help us learn more about what affects the quality of life of people with diabetes in five dimensions of patients' lives: Diabetes Control, Anxiety and Worry, Social Burden, Sexual Functioning and Energy and Mobility. The Diabetes-39 questionnaire uses a Not Affected At All -Extremely Affected point scale score ranging from 1-7. Raw scale scores were transformed to a 0-100 scale using a linear transformation. Higher values represent a worse outcome. Overall rating of Quality-of-Life was assessed using a Lowest quality-Highest quality scale ranging from 1-7. Higher values represent an increase or improvement in overall QOL. Pattern of Diabetes Severity was measured with a Not Severe at all-Extremely Severe scale ranging from 1-7. Higher values represent increase in diabetes severity.|Month 0 and month 6||||units on a scale||Standard Deviation|Mean
2785697|NCT00624013|Primary|HbA1C (%)|Change in HbA1C (%) at month 0 and month 6|Month 0 and month 6||||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
2785698|NCT00623974|Primary|Number of Patients With Success|"A patient success is defined as a normal calcium level (Ca>=8 and Ca<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation."|2 - 7 days post-treatment|Terminated due low accrual, none of 7 participants met eligibility criteria therefore not treated nor randomized to study arms.||||||
2785699|NCT00623935|Secondary|Percentage of Participants Alive at 1 Year|One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).|||percentage of participants||95% Confidence Interval|Number
2785700|NCT00623935|Primary|Percentage of Participants With Relapse Free Survival at 1 Year|The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).|||percentage of participants||95% Confidence Interval|Number
2785701|NCT00623831|Secondary|Number of Participants With Best Overall Tumor Response|Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 3 months|The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.|||participants|||Number
2785702|NCT00623831|Secondary|Number of Participants With Serum NY-ESO-1-specific Immune Responses|Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. [Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor]|Up to 3 months|The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.|||participants|||Number
2785703|NCT00623831|Primary|Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU|Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.|Weeks 1 through 6|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
2785775|NCT00623623|Secondary|Number of Patients With All Cause Mortality|This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported.|30 days|FAS|||Participants|||Count of Participants
2785707|NCT00623805|Secondary|Duration of Response|Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|||||||
2785708|NCT00623805|Secondary|Time Until a Complete Response or a Partial Response|Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.|Baseline to Month 13|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.|||Months||Standard Deviation|Mean
2785709|NCT00623805|Secondary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Percentage of participants|||Number
2785710|NCT00623805|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Months||Standard Error|Mean
2785711|NCT00623805|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.|||Months||Standard Error|Mean
2785712|NCT00623779|Secondary|Ecarin Clotting Time (ECT)|Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)||||sec||Full Range|Median
2785713|NCT00623779|Secondary|Activated Partial Thromboplastin Time (APTT)|Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)||||sec||Full Range|Median
2785714|NCT00623779|Secondary|Change in D-Dimer Level|Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)||||ng/ml||Full Range|Median
2785715|NCT00623779|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit|4 weeks after baseline according to protocol||||nmol/L||Full Range|Median
2785716|NCT00623779|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit|4 weeks after baseline according to protocol||||nmol/L||Full Range|Median
2785717|NCT00623779|Secondary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3|||Participants|||Number
2785718|NCT00623779|Secondary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3|||Participants|||Number
2785719|NCT00623779|Secondary|Change in Creatinine Level|Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol (randomisation visit to week 4 visit)||||umol/L||Standard Deviation|Mean
2785757|NCT00623623|Secondary|Number of Patients With Minor Non-intracranial Bleeds|This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2788477|NCT00605319|Primary|Maximum Flow Rate (Qmax)|Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary|screening (Month 0), 2-months, 3-months, 7-months||||mL/s||Standard Deviation|Mean
2785720|NCT00623779|Secondary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3|||Participants|||Number
2785721|NCT00623779|Primary|Compliance With Study Visits/Assessments|(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100|28 weeks (randomisation visit to last follow up visit) according to protocol||||Percentage||Standard Deviation|Mean
2785722|NCT00623779|Primary|Compliance With Study Drug|[(number of doses dispensed-number of doses returned)/number of days between visits]*100|24 weeks (randomisation visit to last treatment visit) according to protocol||||Percentage||Standard Deviation|Mean
2785723|NCT00623779|Primary|Premature Discontinuation of Study Due to Any Reason|"|The premature discontinuation of study due to any reason"|28 weeks (randomisation visit to last follow up visit)||||Participants|||Number
2785724|NCT00623779|Primary|Premature Discontinuation of Study Drug Due to Any Reason|The premature discontinuation of study drug due to any reason|24 weeks (randomisation visit to last treatment visit)||||Participants|||Number
2785725|NCT00623779|Primary|Premature Discontinuation of Study or Study Drug Due to Any Reason|The premature discontinuation of study or study drug due to any reason|28 week (randomisation visit to last follow up visit in study) according to protocols||||Participants|||Number
2785726|NCT00623766|Secondary|Overall Survival (OS)|OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive.|From first dose to 24 months|All participants who received at least 1 dose of ipilimumab|||Months||95% Confidence Interval|Median
2785727|NCT00623766|Secondary|Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)|Onset of response is defined as the time between the first dose of study therapy and the date when measurement criteria are first met for global best overall response of partial (PR) or complete (CR), whichever occurs first. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions.|From Day 1, first dose to a maximum of 4.2 months|All participants who received at least 1 dose of ipilimumab. n=number of participants with a best overall response of CR or PR.|||Months||Full Range|Median
2785728|NCT00623766|Secondary|Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from Day 1, first dose, to 70 days following last dose of ipilimumab|All participants who received at least 1 dose of ipilimumab|||Participants|||Number
2785729|NCT00623766|Secondary|Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)|OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated.|From first dose to Months 6, 12, 18, 24, and 36 months|All participants who received at least 1 dose of ipilimumab|||Probability of being alive||95% Confidence Interval|Number
2785730|NCT00623766|Secondary|Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|PFS is defined as the time between the date of the first dose of study therapy and the date of progression or death, whichever occurs first. A patient who dies without reported prior progression will be considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS will be censored on the date of last evaluable tumor assessment. Participants who have not died and have no recorded postbaseline tumor assessment will be censored on the date of first dose of study therapy. Those who die without any recorded postbaseline tumor assessment will be considered to have progressed on the date of death.|From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months|All participants who received at least 1 dose of ipilimumab|||Months||95% Confidence Interval|Median
2785731|NCT00623766|Secondary|Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|DOR is defined in patients whose global best overall response is complete (CR) or partial response (PR) as the time between the date of response of confirmed CR or PR, whichever occurs first, and the date of progressive disease or death, whichever occurs first. For patients who remain alive and have not progressed following response, duration of response will be censored on the date of last evaluable tumor assessment.|From Day 1, first dose to last tumor assessment up to 18.2 months|All participants who received at least 1 dose of ipilimumab|||Months||95% Confidence Interval|Median
2785758|NCT00623623|Secondary|Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions|This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785759|NCT00623623|Secondary|Number of Patients With Total Stroke (All Types)|This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785732|NCT00623766|Secondary|Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)|BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met.|From Day 1, first dose until the last tumor assessment, Week 12|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
2785733|NCT00623766|Secondary|Disease Control Rate by Immune-related Response Criteria (irRC)|Disease control rate is defined as the number of patients with a best overall response of immune-related (ir) complete response (irCR), partial response (irPR), or stable disease (irSD) divided by the total number of patients who received treatment. By irRC definition: irCR=complete disappearance of all index lesions. irPR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. irSD=does not meet criteria for irCR or irPR, in the absence of ir progressive disease (irPD). irPD=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline). CNS=central nervous system; non-CNS compartment=extracranial, or outside of the brain.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
2785734|NCT00623766|Primary|Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria|Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
2785735|NCT00623727|Other Pre-specified|Percentage of Participants With Less Than 9 Total Bleeds Per Year in the Open Label Extension Period|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|6 months after start of open label extension period|Participants who completed open label extension period|||Percentage of participants|||Number
2785736|NCT00623727|Other Pre-specified|Total rFVIII Consumption Per Year|Total number of units per kg of study medication (rFVIII) administered to participant for one year. rFVIII is recombinant factor VIII, factor VIII is functional coagulation factor|up to one year|ITT population|||IU per kg||Full Range|Median
2785737|NCT00623727|Other Pre-specified|Percentage of Bleeds Treated by Various Numbers of Injections|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP Population|||percentage of bleeds|||Number
2785738|NCT00623727|Other Pre-specified|Number of Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Number of bleeds 3 weeks after the first infusion per 12 months|up to one year|PP population|||bleeds per year||Full Range|Median
2785739|NCT00623727|Secondary|Number of Joint Bleeds Per Participant Per Year in Responders|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Responders were the subjects with less than 9 total bleeds per year|up to one year|PP population in responders|||Joint bleeds per year||Full Range|Median
2785740|NCT00623727|Secondary|Percentage of Participants With Less Than 5 Joint Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP population|||Percentage of participants|||Number
2785741|NCT00623727|Primary|Percentage of Participants With Less Than 9 Total Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|Per protocol (PP) population|||Percentage of participants|||Number
2785742|NCT00623714|Secondary|Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated|||pg/mL||95% Confidence Interval|Geometric Mean
2785743|NCT00623714|Primary|Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated|||pg/mL||95% Confidence Interval|Geometric Mean
2785744|NCT00623636|Secondary|Number of Subjects With Pain Relief at 10 Minutes|"Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785745|NCT00623636|Secondary|Number of Subjects With Pain Relief at 4 Hours|"Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|4 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785746|NCT00623636|Secondary|Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours|"The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included.~The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from the first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785747|NCT00623636|Secondary|Number of Subjects With Sustained Pain Relief From 2 to 24 Hours|"Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|From 2 to 24 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785748|NCT00623636|Primary|Number of Subjects Nausea Free at 2 Hours From Time of First Dose|"Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785749|NCT00623636|Primary|Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose|"Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785750|NCT00623636|Primary|Number of Subjects Photophobia Free at 2 Hours From Time of First Dose|"Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785751|NCT00623636|Primary|Number of Subjects With Pain Relief at 2 Hours From Time of First Dose|"Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.|||participants|||Number
2785752|NCT00623623|Secondary|Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke|This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785753|NCT00623623|Secondary|Number of Patients With All Cause Death and Non-fatal Stroke|This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785754|NCT00623623|Secondary|Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures|This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785755|NCT00623623|Secondary|Number of Patients With Serious Resuscitated Ventricular Fibrillation|This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785756|NCT00623623|Secondary|Number of Patients With Total Non-intracranial Bleeds|This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported|30 days|FAS|||Participants|||Count of Participants
2785776|NCT00623623|Primary|Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.|The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).|30 days|Full analysis set (FAS): All consented patients either randomised by Interactive Voice Response System (IVRS) or treated (i.e., manually allocated to treatment group) by the investigator. This population is also referred to as the intention-to-treat population (ITT).|||Participants|||Count of Participants
2785777|NCT00623597|Primary|Change In Hematuria, Glycosuria And Proteinuria From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||[0 to 4+]||Standard Deviation|Mean
2785778|NCT00623597|Primary|Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||mmol/L||Standard Deviation|Mean
2785779|NCT00623597|Primary|Change In Total Bilirubin, Creatinine, Uric Acid From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||umol/L||Standard Deviation|Mean
2785780|NCT00623597|Primary|Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||U/L||Standard Deviation|Mean
2785781|NCT00623597|Primary|Change In Red Blood Cell (RBC) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||10*12/L||Standard Deviation|Mean
2785782|NCT00623597|Primary|Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||10*9/L||Standard Deviation|Mean
2785783|NCT00623597|Primary|Change In Hemoglobin, Total Protein And Total Albumin From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||g/L||Standard Deviation|Mean
2785784|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count|Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) - (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||count/uL||Standard Deviation|Mean
2785785|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count|Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) - (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||count/uL||Standard Deviation|Mean
2785786|NCT00623597|Secondary|Number of Participants With Virological Failure|Virological failure was defined as: viral load >= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, >10,000 copies) were presented.|From Week 12 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
2785787|NCT00623597|Secondary|Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA )|The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported|From Week 8 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
2785788|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL|The number of participants with HIV-1 RNA results <50 copies/mL were reported.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
2785865|NCT00623194|Secondary|Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies|Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.|At 0, 52 and 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension period.|||Percent bound of total||Standard Error|Mean
2785789|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL|The number of participants with HIV-1 RNA results <400 copies/mL were reported|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
2785790|NCT00623597|Secondary|Change From Baseline in Mean Human Immunodeficiency Virus Viral Load|Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline)|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population (SAP) comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||log10 copies/mL||Standard Deviation|Mean
2785791|NCT00623597|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||h*ug/mL||Standard Deviation|Mean
2785792|NCT00623597|Secondary|Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||ng/mL||Standard Deviation|Mean
2785793|NCT00623597|Secondary|Plasma Trough Concentrations (Ctrough) for Ritonavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg.|Pre-dose at Weeks 8, 12, 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||ng/mL||Standard Deviation|Mean
2785794|NCT00623597|Primary|Change In Hematocrit From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||fraction||Standard Deviation|Mean
2785795|NCT00623597|Primary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|From Baseline (Day 1) till Week 48 and Follow-up (Week 52)|The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.|||participants|||Number
2785796|NCT00623597|Primary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||h*ug/mL||Standard Deviation|Mean
2785797|NCT00623597|Primary|Plasma Trough Concentrations (Ctrough) for Saquinavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose at Weeks 8, 12, 24.|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.|||ng/mL||Standard Deviation|Mean
2785798|NCT00623545|Secondary|Weight Loss After Administration of Exenatide.|Body weight after overnight fast in light clothing|3 months||||kg||Standard Deviation|Mean
2785799|NCT00623545|Primary|Change in Energy Intake Measured Before Treatment and at the End of Treatment.|Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.|3 months|Those that completed baseline and final measurements.|||kcal/d||Standard Deviation|Mean
2786028|NCT00621855|Secondary|Laboratory Analyses|Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
2785800|NCT00623506|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability,sleep,weight/appetite change,and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.|||units on a scale||Standard Error|Mean
2785801|NCT00623506|Secondary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 10) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.|||units on a scale||Standard Error|Mean
2785802|NCT00623506|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|Mean change scores (Week 2 minus Week 10) to assess cognitive changes. The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Mean
2785803|NCT00623480|Other Pre-specified|Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A|The Haemo-QoL-A total score as well as each of its domains have a range between 0 (worst Quality of Life) and 100 (best Quality of Life) points. Therefore, a higher Haemo-QoL-A score denotes greater Quality of Life.|Baseline and 3 years|Full Analysis Set|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2785804|NCT00623480|Secondary|Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale|The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening. CAJAS total score is the sum of all 6 joints, ranging from 0 (best possible outcome) to 142 (worst possible outcome).|Baseline and 3 years|Full Analysis Set|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2785805|NCT00623480|Secondary|Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.|The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.|Baseline and 3 years|Full Analysis Set|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2785806|NCT00623480|Primary|Bleeding Frequency (Number of Total Bleeds)||After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)|ITT (Intent-to-treat) Population|||Bleeds||Full Range|Median
2785807|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|FAS|||scores on a scale||Standard Deviation|Mean
2785808|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|FAS|||scores on a scale||Standard Deviation|Mean
2785809|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785810|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785862|NCT00623194|Secondary|Hypoglycaemic Episodes|"Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.~Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment."|Weeks 0-104|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||events|||Number
2785811|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785812|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785813|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785814|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785815|NCT00623467|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785816|NCT00623467|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785817|NCT00623467|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
2785818|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2785863|NCT00623194|Secondary|Fasting Plasma Glucose Values|FPG (Fasting Plasma Glucose) values after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.|||mmol/L||Standard Deviation|Mean
2786271|NCT00620061|Secondary|Bowel Habit Regularity by Month|"Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.~The highest score is 7, but the best score is 1."|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the given time point|||score on a scale||Standard Deviation|Mean
2785819|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
2785820|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785821|NCT00623467|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785822|NCT00623467|Secondary|Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. The data for contrast enhancement - gadobutrol combined was shown below.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785823|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785824|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785825|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785826|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785836|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785827|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785828|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785829|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785830|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785831|NCT00623467|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS|||lesions||Standard Deviation|Mean
2785832|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|"The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible. The data for contrast enhancement - unenhanced were not collected for the clinical investigators."|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785833|NCT00623467|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS|||lesions||Standard Deviation|Mean
2785834|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2785835|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2786308|NCT00619957|Secondary|Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2785837|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI and combined unenhanced and gadobutrol-enhanced MRI, excluding the sample participants (the first participant from each study site).|||scores on a scale||Standard Deviation|Mean
2785838|NCT00623441|Primary|MACE (Major Adverse Cardiac Events)|MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))|12 Months|Intention to Treat (ITT)|||Percentage of participants|||Number
2785839|NCT00623428|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as incapacitating with inability to work or perform normal daily activity. A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above."|From Week 1 through Week 72.||||participants|||Number
2785840|NCT00623428|Secondary|Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.|12 weeks after actual end of treatment (range from Week 36 to Week 60)|All randomized patients.|||percentage of participants|||Number
2785841|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.|24 weeks after actual end of treatment (range from Week 48 to Week 72).|All randomized patients.|||percentage of participants|||Number
2785842|NCT00623428|Secondary|Percentage of Participants With Virological Relapse|"Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.~Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.~Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end."|End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).|Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement.|||percentage of participants|||Number
2785843|NCT00623428|Secondary|Percentage of Participants With Virological Response at End of Treatment|Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.|End of Treatment (Week 24 and Week 48 for each treatment group respectively).|All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was <15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment).|||percentage of participants|||Number
2785844|NCT00623428|Secondary|Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation|"Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.~Participants without Week 72 measurements were considered non-responders in the analysis."|Week 72|All randomized patients.|||percentage of participants|||Number
2785845|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment|"Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.~Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis."|24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.|All randomized patients.|||percentage of participants|||Number
2785864|NCT00623194|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2785846|NCT00623233|Secondary|1-Year Overall Survival (OS) Rate|OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data.|Baseline to death from any cause, 1 year|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=25; censored participants=27.|||percentage of participants||95% Confidence Interval|Number
2785847|NCT00623233|Secondary|Number of Participants With Adverse Events (AEs); Pharmacology Toxicities|A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.|Baseline, every cycle (every 14 days) up to 34 months|The safety population was the treated population and included all participants who received at least 1 dose of study therapy.|||participants|||Number
2785848|NCT00623233|Secondary|Overall Tumor Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population).|Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).|The per protocol (PP) population included all intent-to-treat (ITT) participants who met the following criteria: histological or cytological diagnosis of breast cancer; presence of measurable disease at baseline per RECIST criteria; had at least 1 dose of study drug; no current systemic anti-tumor treatment other than protocol-specified therapy.|||proportion of responders||95% Confidence Interval|Number
2785849|NCT00623233|Primary|Progression Free Survival (PFS) Time|PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.|Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=41; censored participants=11.|||months||95% Confidence Interval|Median
2785850|NCT00623194|Secondary|Vital Signs: Pulse|Pulse at week 104|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||beats/minute||Standard Deviation|Mean
2785851|NCT00623194|Secondary|Vital Signs: Blood Pressure|Blood pressure (Systolic and Diastolic) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||mmHg||Standard Deviation|Mean
2785852|NCT00623194|Secondary|Fundoscopy/Fundus Photography|"Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant~Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant"|at 52 weeks and at 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||participants|||Number
2785853|NCT00623194|Secondary|Laboratory Values: Leukocytes and Thrombocytes|Leukocytes and Thrombocytes after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||10^9/L||Standard Deviation|Mean
2785854|NCT00623194|Secondary|Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)|Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||U/L||Standard Deviation|Mean
2785855|NCT00623194|Secondary|Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)|Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||mmol/L||Standard Deviation|Mean
2785856|NCT00623194|Secondary|Laboratory Values: Creatine Serum Umol/L|Creatine serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||Umol/L||Standard Deviation|Mean
2785857|NCT00623194|Secondary|Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)|Albumin Serum and Total Protein Serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||g/dL||Standard Deviation|Mean
2785858|NCT00623194|Secondary|Insulin Dose|Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||U/kg||Standard Deviation|Mean
2785859|NCT00623194|Secondary|Diabetic Ketoacidosis|Diabetic ketoacidosis requiring hospitalisation|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||events|||Number
2785860|NCT00623194|Secondary|SD-score (Z-score) for Body Weight|Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||SD-scores||Standard Deviation|Mean
2785861|NCT00623194|Secondary|BMI (Body Mass Index)|BMI (Body Mass Index) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.|||kg/m^2||Standard Deviation|Mean
2786309|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2785866|NCT00623194|Primary|Insulin Detemir-insulin Aspart Cross-reacting Antibodies|Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.|week 0, 52 and 104|"Full analysis set 146 (100%), safety analysis set 146 (100%)~The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.~The safety analysis set included all subjects with a signed informed consent who were exposed in the extension."|||Percent bound of total||Standard Error|Mean
2785867|NCT00623181|Other Pre-specified|Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection|"Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.~Data for this outcome were based on the first vaccination type, intradermal or intramuscular."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.|||Participants|||Number
2785868|NCT00623181|Other Pre-specified|Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.|||Participants|||Number
2785869|NCT00623181|Primary|Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0, 3, and 7 after vaccination||||Scores on a scale||Standard Deviation|Mean
2785870|NCT00623181|Primary|Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Day 0 and up to 7 days post-vaccination|Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.|||Participants|||Number
2785871|NCT00623103|Secondary|UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).|From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)|The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.|||Score||Standard Deviation|Mean
2785872|NCT00623103|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|"The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.~The change from baseline was calculated such that a positive change indicates an improvement."|From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).|||Score||Standard Deviation|Mean
2785873|NCT00623103|Secondary|Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).|At Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)|||Score||Standard Deviation|Mean
2785874|NCT00623103|Secondary|Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)|||Score on a scale||Standard Deviation|Mean
2785889|NCT00622895|Secondary|Skin Score|The skin score measure is a scale: the name of the scale is the modified Rodnan skin score (mRSS). Total score of mRSS is from 0 to 51. Higher values represents worse skin score. Highest value is 51, represents very hidebound tight thick skin. Lowest value is 0, represent normal skin, no tightness.|Up to 5 years post-transplant|One patient was evaluated at baseline and at 5 years post-transplant. Skin score was evaluated using modified Rodnan skin score (mRSS).|||units on a scale (mRSS)|||Number
2786310|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2785875|NCT00623103|Secondary|Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline|Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention [0-37], Initiation/Perservation [0-37] (performing alternating movements), Construction [0-6] (copying designs), Conceptualization [0-39] (similarities) and Memory [0-25] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)|||Score on a scale||Standard Deviation|Mean
2785876|NCT00623103|Secondary|Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.|From Baseline to Weeks 8, 16, 24, 52 and 76|"Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. n in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements."|||Score on a scale||Standard Deviation|Mean
2785877|NCT00623103|Primary|Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
2785878|NCT00623103|Primary|Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
2785879|NCT00623012|Secondary|Disease Free Survival|achieved disease free in regard to leukemia|up to 10 weeks||||participants|||Number
2785880|NCT00623012|Secondary|Overall Survival|achieved overall survival in regard to leukemia|up to 10 weeks||||participants|||Number
2785881|NCT00623012|Primary|Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.|Percentage of patients free from graft versus host disease|up to 8 weeks||||percentage of patients|||Number
2785882|NCT00622908|Secondary|Eradication of Baseline Pathogens Day 4 (+/- 1 Day)|Bacterial species eradication of baseline bacterial infection|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
2785883|NCT00622908|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)|The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
2785884|NCT00622908|Primary|Eradication of Baseline Pathogens (Day 8 or 9)|Bacterial species eradication of baseline bacterial infection|Visit 3 - Day 8 or day 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
2785885|NCT00622908|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)|Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 3 - day 8 or 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.|||Participants|||Number
2785886|NCT00622895|Secondary|Incidence of Disease-modifying Antirheumatic Drugs (DMARDs) Initiated Post Transplant to Modify Disease|Percent of patients treated with DMARDS after allogeneic transplant in order to treat scleroderma disease signs and symptoms.|Up to 5 years post-transplant|3 patients enrolled were evaluable.|||Participants|||Count of Participants
2785887|NCT00622895|Secondary|Incidence and Severity of Graft-versus-host Disease (GVHD)|The grading of acute and chronic GVHD will follow previously published guidelines and according to institutional standard of practice but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and SSc involve the skin and the gastrointestinal tract, all diagnostic biopsies of these organs will be centrally reviewed by a study pathologist.|Up to 5 years post-transplant|"1 patient out of the 3 patients enrolled was evaluable for both acute and chronic GVHD. The grade of acute GVHD ranges from 0 to 4. Minimum score of 0 is normal or no GVHD. Maximum score of 4 is fatal GVHD.~Chronic GVHD minimum score is 0 (none), maximum score 3: extensive and severe."|||units on a scale|||Number
2785888|NCT00622895|Secondary|Incidence of Graft Rejection|Engraftment is defined as achieving > 5% donor peripheral blood T cell chimerism by Day 56 after HCT. Primary graft failure is defined as a donor peripheral blood T cell chimerism peak of < 5% by Day 56 post-HCT. Methodological requirements for chimerism are as defined by institutional standard of practice. Secondary Graft Failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood T cell chimerism < 5% as demonstrated by a chimerism assay|Up to day +56||||Participants|||Count of Participants
2786311|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 6, ITT Population.||Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2785890|NCT00622895|Secondary|Quality of Life as Assessed by the Medical Outcome Short Form (36) Health Survey Instrument (SF-36)|The Medical Outcome Short Form (36) Health Survey instrument (SF-36) is a general assessment of health quality of life with eight components: physical functioning, role limitations due to physical health, pain index, general health perceptions, vitality, social functioning, role limitations due to emotional problems and Mental Health Index. Each domain is positively scored, indicating that higher scores are associated with positive outcome.|Up to 5 years|"Pre-transplant (baseline) evaluation of physical functioning. Score from 0 to100 with 0 perfect health and 100 poor health.~The pre-transplant (baseline) evaluation was completed by study participant. The participant did not complete the 5 year post transplant evaluation.~The 5 year post-transplant SF32 form was not completed by the patient."|||units on a scale|||Number
2785891|NCT00622895|Secondary|Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ)|The questionnaire includes measure of quality of life and measure of the scale of skin tightness, activity level and function specifically designed for patients with systemic sclerosis|Up to 5 years|One patient completed the pre-transplant and 5 year post transplant SHAQ (scleroderma health assessment questionnaire). Score range from 0 to 3. Minimum score: Score of 0 is excellent health. Maximum score: score of 3 is most severely impaired, poor quality of life.|||units on a scale|||Number
2785892|NCT00622895|Secondary|The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections|The percent of participants with definite and probable viral, fungal, and bacterial infections after transplant|Up to 5 years||||Participants|||Count of Participants
2785893|NCT00622895|Secondary|Regimen-related Toxicity (Greater Than or Equal to Grade III) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|"Grades 3, 4 and 5 adverse events will be tracked from the start of mobilization or conditioning until day +100 after transplant or until patient departure from the center, whichever occurs first.~Certain adverse events are usual and expected after transplant and will only be reported if they are > Grade 4. Some Grade 4 events that are routinely expected (i.e. pancytopenia) will not be reported."|Up to 5 years|3 patients received umbilical cord blood (UCB) transplant.|||Participants|||Count of Participants
2785894|NCT00622895|Secondary|Treatment-related Mortality|Defined as death occurring at any time after start of allogeneic HCT and definitely or probably resulting from treatment given in the study and not associated with disease progression.|From time of transplant to 5 years||||Participants|||Count of Participants
2785895|NCT00622895|Secondary|Overall Survival|Event is defined as death due to any cause.|Up to 5 years|survival of patients after UCB|||Participants|||Count of Participants
2785896|NCT00622895|Secondary|EFS|event-free survival after umbilical cord blood transplant|5 years||||Participants|||Count of Participants
2785897|NCT00622895|Primary|Event-free Survival (EFS)|The events will be defined as any one of the following: death; respiratory failure; renal failure, as defined by chronic dialysis > or = 6 months or kidney transplantation; occurrence of cardiomyopathy, confirmed by clinical CHF (New York Class III or IV) or LVEF < 30% by echocardiogram, sustained for at least 3 months despite therapy; organ dysfunction specific events must be documented on at least two occasions > or = 3 months apart, or sustained for a 3-month period (documented from the first occurrence).|2 years|UCB transplant recipients|||Participants|||Count of Participants
2785898|NCT00622869|Secondary|Change in Renal Function From Randomization to Months 12 and 24|"Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.~The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported."|Randomization to Month 24|Intent-to-treat population: All randomized patients.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2785899|NCT00622869|Secondary|Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24|"tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.~The incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.|||Percentage|||Number
2785900|NCT00622869|Secondary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 24|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death.~The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.|||Percentage|||Number
2785901|NCT00622869|Primary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 12|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.~The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 12|Intent-to-treat population: All randomized patients.|||Percentage of participants|||Number
2785902|NCT00622739|Secondary|Barnes Akathisia Rating Scale (BARS)|"The BARS measures drug-induced akathisia occurring specifically with use of neuroleptic agents. It is a four-item fully anchored scale. Three items (objective akathisia, subjective awareness of restlessness, and subjective distress related to restlessness) are rated on a 4-point scale (0= normal and 9= most severe) and, the global clinical assessment of akathisia uses a 5-point scale (0= normal and 4= most severe).~Total scores ranged from 0-13 with higher scores reflecting more akathisia."|6 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2785903|NCT00622739|Secondary|AIMS (Abnormal Involuntary Movement Scale)|AIMS is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs, such as tardive dystonia and chronic akathisia, as well as 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in three main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe).|6 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2785904|NCT00622739|Secondary|SAFTEE (Side Effects Rating Scale)|The Systematic Assessment for Treatment of Emergent Events (SAFTEE) is one of the first comprehensive Adverse effects-elicitation instruments developed specifically for use in psychiatric clinical trials. The SAFTEE is a standardized method, which increases consistency of Adverse Effects data, both within and across clinical trials.It allows ratings of five levels of severity and collects information about the onset, duration, pattern, judgement of attribution of cause, and action taken by the clinician. Suggested probe questions are also provided, which the clinician can use to elicit detailed information about the AE. Furthermore, the SAFTEE requires the clinician to determine a time interval of inquiry to be used in the trial. Adverse Effects are graded as None=0, Mild=1, Moderate=2, Severe=3.|6 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2785905|NCT00622739|Secondary|Clinical Global Impressions-Severity (CGI-S) Scale|"The CGI-S assesses clinical severity. The CGI-S is a seven point scale where 1 is the minimum value and 7 is the maximum value. Lower scores mean a better outcome.~The CGI-Severity scale scores are: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|6 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2785906|NCT00622739|Secondary|Children's Depression Rating Scale|The CDRS-R is a 17 item clinician-rated instrument used to measure severity of depressive symptoms in youth (ages 6-18). Each item is rated on a 1 to 5 or 1 to 7 point scale, with a 1 describing absence of the given symptom. The CDRS-R yields a total score from 17 to 113 with a score of 40 or greater considered to symptomatic of depression. Scores of 35-40 indicate mild depression, 29-34 is borderline and <28 is no depression.|6 weeks of treatment||||score on a scale||Standard Error|Least Squares Mean
2785907|NCT00622739|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.|6 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2785908|NCT00622726|Secondary|Visual Acuity|The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.|Age 7 years.|||||||
2785909|NCT00622726|Secondary|Myopia in Zone I and Posterior Zone II of Infant Eyes|Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.|2.5 years of age|As of 6/2013, there were 13 deaths/ 26 eyes. Exclusions from surviving 137 infants/ 274 eyes: 6 infants/19 eyes with intraocular surgery--leaving: 131 infants/ 255 eyes; 14 infants/ 21 eyes had recurrence and 22 infants/ 44 eyes were lost to follow-up--leaving: 95 infants/ 190 eyes. Thus, only the refractions on these infants/ eyes are given.|||Diopters|Eyes|Standard Deviation|Mean
2785910|NCT00622726|Primary|Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment|"For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization.~For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation)."|54 weeks postmenstrual age (window of 50 to 70 weeks)|Both eyes of all surviving infants were analyzed for recurrence: thus, 143 surviving infants and 286 eyes were analyzed. Reporting the number of eyes that developed recurrences|||eyes with recurrences|Eyes||Number
2785911|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||Scores on a scale||Standard Deviation|Mean
2785912|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||scores on a scale||Standard Deviation|Mean
2785913|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score|The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||scores on a scale||Standard Deviation|Mean
2786312|NCT00619957|Secondary|Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.||Baseline to Month 3|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2785914|NCT00622713|Secondary|Clinical Global Impression of Change (CGI-C) by Physician|"The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:very much improved, much improved, slightly improved, unchanged, slightly worsened, much worsened and very much worsened."|Baseline and week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. Last observation carried forward (LOCF) was used for missing values.|||Percentage of participants|||Number
2785915|NCT00622713|Primary|Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study|The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.|24 weeks|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||Percentage of participants|||Number
2785916|NCT00622700|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5, 2, or 3 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population as described in Outcome Measure 13. Here 'n' signifies the number of participants for the treatment group who had that parameter assessed at post-baseline.|||participants|||Number
2785917|NCT00622700|Secondary|Extension Treatment Period: Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.|From re-randomization up to 283 Weeks|Analysis was performed on Safety population. In Placebo/teriflunomide 7mg arm, 2 received 7mg in the core period; In Placebo/teriflunomide 14mg, 1 received 7mg in the core period, hence, they were included in the 7mg/7mg arm in extension period as treatment received in the core period for consistency.|||participants|||Number
2785918|NCT00622700|Secondary|Extension Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.|From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])|ITT Population: all randomized participants in the extension who had at least 1 day IMP exposure. Participants were analyzed according to the treatment group allocated by the randomization in the core study followed by the re-randomized treatment group during the extension period.|||Percent probability||95% Confidence Interval|Number
2785919|NCT00622700|Secondary|Core Treatment Period: Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population:all randomized participants exposed to study medication; analyzed according to drug actually received. In Placebo arm, 4 received teriflunomide 7mg & 2 received teriflunomide 14mg, hence they were included in respective teriflunomide arm. Participants who were randomized but not treated were excluded (2 in each teriflunomide arm).|||participants|||Number
2785920|NCT00622700|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2785921|NCT00622700|Secondary|Core Treatment Period: Change From Baseline in EDSS at Week 108|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2785922|NCT00622700|Secondary|Core Treatment Period: Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.|||percent probability||95% Confidence Interval|Number
2785923|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy|Atrophy was measured by MRI scan.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||percent change||Standard Deviation|Mean
2785924|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component|Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
2785925|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
2785926|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.|||milliliters per scan|||Number
2785927|NCT00622700|Secondary|Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.|||lesions per scan||95% Confidence Interval|Number
2785928|NCT00622700|Secondary|Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
2785929|NCT00622700|Secondary|Core Treatment Period: Annualized Relapse Rate (ARR)|ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.|||relapses per patient year||95% Confidence Interval|Number
2785930|NCT00622700|Secondary|Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)|Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.|||percent probability||95% Confidence Interval|Number
2785931|NCT00622700|Primary|Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population included all randomized participants who had at least 1 day study medication exposure. Participants were analyzed in the treatment group to which they were randomized.|||percent probability||95% Confidence Interval|Number
2785932|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785933|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785934|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|22 hours post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785935|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785936|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785937|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|14 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785938|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 45 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785939|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 10 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785940|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|10 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785941|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|8 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785942|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|6 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785943|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785980|NCT00622336|Secondary|Duration of Response|Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.|Up to 70 months|Duration of response not analyzed per the sponsors decision.||||||
2785944|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|4 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785945|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|3 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785946|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|2 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785947|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|1 hour post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785948|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|30 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785949|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|15 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785950|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785951|NCT00622635|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|After 14 days|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2785952|NCT00622544|Secondary|Number of Subjects Developing Proteinuria During the Study Period|number of subjects developing proteinuria during the study period|2007-2009||||Participants|||Count of Participants
2785953|NCT00622544|Primary|Number of Subjects Developing Microalbuminuria During Study Period|number of subjects developing microalbuminuria during study period|2007-2009||||Participants|||Count of Participants
2785954|NCT00622518|Secondary|Side Effects of Therapy||5 days|Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects.|||participants|||Number
2785955|NCT00622518|Primary|Resolution of Otitis Media Symptoms|Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.|5 days|Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED|||units on a scale||Standard Deviation|Mean
2785967|NCT00622388|Secondary|Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.|Visit 2 (Week 0) and Visit 9 (Week 7)|FAS. Data are provided for the number of participants attending each visit.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2785956|NCT00622440|Secondary|Response With >75% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)~No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, Week 48, and Week 60; up to 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >75% adherence to treatment|||participants|||Number
2785957|NCT00622440|Secondary|Response With >50% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)~No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, Week 48, and Week 60; up to 60 weeks|Evaluable participants who finished 48 weeks of treatment and reported >50% adherence to treatment|||participants|||Number
2785958|NCT00622440|Secondary|Treatment Adherence|"Percent of recommended applications of cream reported in participant diary.~>75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent"|Up to 48 weeks|Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.|||participants|||Number
2785959|NCT00622440|Primary|Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)|"Response assessed 12 weeks after treatment.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)~No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, Week 48, and Week 60; up to 60 weeks||||participants|||Number
2785960|NCT00622427|Secondary|Change in Clinical Global Impression (CGI)|The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.|day 1 to day 14 of study drug||||percentage of change||Standard Deviation|Mean
2785961|NCT00622427|Primary|Change in Baseline to 2 Weeks ADHD Rating Scale|It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.|day 1 to day 14 of study drug||||percentage of change||Standard Deviation|Mean
2785962|NCT00622401|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.|This outcome was not measured because no patients were treated with rhIL-12.|3 years|This outcome was not measured because no patients were treated with rhIL-12.||||||
2785963|NCT00622401|Primary|Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine|Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.|3 years|All three patients experienced adverse events that were determined to be at least possibly related to the vaccine. The number of times each toxicity was observed is captured in the adverse events section.|||participants|||Number
2785964|NCT00622388|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; up to 11 months after the last dose)|FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated.|||liters||Geometric Coefficient of Variation|Geometric Mean
2785965|NCT00622388|Secondary|Clearance (CL) of Ofatumumab at the Eighth Infusion|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated.|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2785966|NCT00622388|Secondary|Half-life (T1/2) for Ofatumumab at the Eighth Infusion|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
2785998|NCT00622284|Secondary|HbA1c Change at Week 4|Difference of base percent value [Week x(%) - baseline (%)]|Baseline and week 4|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785968|NCT00622388|Secondary|AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data.|||micrograms*hour/milliliter (µg.h/mL)||Geometric Coefficient of Variation|Geometric Mean
2785969|NCT00622388|Secondary|Percent Change From Screening in Complement (CH50) Levels|CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.|Screening and post-baseline visits (last visit was to occur 24 months post first dose)|FAS||||||
2785970|NCT00622388|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).|Time frame is from date of start of treatment to 2 years or withdrawal|FAS|||participants|||Number
2785971|NCT00622388|Secondary|Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits|B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.|Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)|FAS. Data are provided for the number of participants attending each visit.|||percent change in cells||Full Range|Median
2785972|NCT00622388|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18|HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.|Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)|FAS. Data are provided for the number of participants attending each visit.|||participants|||Number
2785973|NCT00622388|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.|From date of start of treatment to 5 years or withdrawal|FAS||||||
2785974|NCT00622388|Secondary|Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy|Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 5 years or withdrawal|FAS|||months||95% Confidence Interval|Median
2785975|NCT00622388|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from treatment start until progression or death.|From date of start of treatment to 2 years or withdrawal|FAS|||months||95% Confidence Interval|Median
2785976|NCT00622388|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 2 years or withdrawal|FAS. Only participants with CR or PR were analyzed.|||months||95% Confidence Interval|Median
2785977|NCT00622388|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response|"According to the revised response criteria for malignant lymphoma, responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD."|6-month period from start of treatment (up to Week 24)|FAS|||participants|||Number
2785978|NCT00622388|Primary|Number of Participants With Objective Response|"Objective response of ofatumumab treatment was assessed according to the revised response criteria for malignant lymphoma. Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease."|6-month period from start of treatment (up to Week 24)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment|||participants|||Number
2785979|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Extension Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.|Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.|||participants|||Number
2789379|NCT00599924|Secondary|Cmin of Free Platinum, Total Platinum, and 5-FU||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
2785981|NCT00622336|Secondary|Myeloma Response Rate|Myeloma response determination criteria developed by Bladé et al 1998. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to 70 months|Myeloma Response Rate not analyzed per the sponsors decision.||||||
2785982|NCT00622336|Secondary|Time to Progression|Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression. The progressive disease criteria included increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|Up to 70 months|Time to progression not analyzed per the sponsors decision.||||||
2785983|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Treatment Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.|The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.|||participants|||Number
2785984|NCT00622284|Secondary|Change in Baseline Lipid Parameter Triglyceride at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dL||Standard Deviation|Mean
2785985|NCT00622284|Secondary|Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dL||Standard Deviation|Mean
2785986|NCT00622284|Secondary|Change in Baseline Lipid Parameter HDL at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dl||Standard Deviation|Mean
2785987|NCT00622284|Secondary|Change in Baseline Lipid Parameter Cholesterol at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.|||mg/dL||Standard Deviation|Mean
2785988|NCT00622284|Secondary|HbA1c Change at Week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785989|NCT00622284|Secondary|HbA1c Change at Week 91||Baseline and week 91|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785990|NCT00622284|Secondary|HbA1c Change at Week 78||Baseline and week 78|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785991|NCT00622284|Secondary|HbA1c Change at Week 65||Baseline and week 65|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785992|NCT00622284|Secondary|HbA1c Change at Week 52||Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785993|NCT00622284|Secondary|HbA1c Change at Week 40||Baseline and week 40|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785994|NCT00622284|Secondary|HbA1c Change at Week 28||Baseline and week 28|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785995|NCT00622284|Secondary|HbA1c Change at Week 16||Baseline and week 16|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785996|NCT00622284|Secondary|HbA1c Change at Week 12||Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2785997|NCT00622284|Secondary|HbA1c Change at Week 8||Baseline and week 8|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Deviation|Mean
2789079|NCT00602355|Primary|Hamilton Depression Rating Scale (HAM-D)|Measure total ranges from 0 to 50, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
2785999|NCT00622284|Secondary|2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.|Baseline and week 104|Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).|||mg/dL||Standard Error|Mean
2786000|NCT00622284|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 104|Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104|Week 104|FAS (NCF)|||Percentage of patients|||Number
2786001|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 104|The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.|||Percentage of patients|||Number
2786002|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 52|The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.|||Percentage of patients|||Number
2786003|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 104|The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.|||Percentage of patients|||Number
2786004|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 52|The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.|||Percentage of patients|||Number
2786005|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.|||mg/dL||Standard Error|Mean
2786006|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 52|This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.|||mg/dL||Standard Error|Mean
2786007|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 104 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)|Week 104|The treated set consisted of all patients treated with at least one dose of study drug|||Patients|||Number
2786008|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 52 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)|Week 52|The treated set consisted of all patients treated with at least one dose of study drug|||Patients|||Number
2786009|NCT00622284|Secondary|Body Weight Change From Baseline at Week 104|This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.|||kg||Standard Error|Mean
2786010|NCT00622284|Secondary|Body Weight Change From Baseline at Week 52|This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.|||kg||Standard Error|Mean
2786011|NCT00622284|Primary|HbA1c Change From Baseline at Week 104|This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Error|Mean
2786012|NCT00622284|Primary|HbA1c Change From Baseline at Week 52|This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.|||Percent||Standard Error|Mean
2786013|NCT00622180|Primary|Percent Repigmentation of Target Lesion|This is measured using photography and Scion software calculations.|25 weeks||||percentage of repigmentation||Standard Deviation|Mean
2789806|NCT00595075|Primary|Sleep Efficiency|total sleep time/time in bed * 100% (higher values indicate better outcome)|2 hours|All participants that completed both crossover periods|||percent||Standard Deviation|Mean
2786014|NCT00622167|Primary|Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).|At time of imaging|Imaging 30 subjects was predicted to include enough plaques for analysis.|||plaques|Participants||Number
2786015|NCT00621985|Primary|Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens|Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.|23 hours|Only four participants completed both the hydrocortisone and dexamethasone admissions.|||Log Mean Area Under the Curve||Standard Deviation|Log Mean
2786016|NCT00621959|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.|Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)|Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline|||points on a scale||Standard Deviation|Mean
2786017|NCT00621959|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period|||points on a scale||Standard Deviation|Mean
2786018|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2786019|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2786020|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2786021|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline||||units on a scale||Standard Deviation|Mean
2786022|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Baseline||||units on a scale||Standard Deviation|Mean
2786023|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline||||units on a scale||Standard Deviation|Mean
2786024|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
2786025|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
2786026|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
2786027|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.|||Percentage of Species|||Number
2789807|NCT00594958|Secondary|SCR for Anti-JEC Neutralizing Antibody Titer||day 56|||||||
2786029|NCT00621855|Secondary|Number of Participants With Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
2786030|NCT00621855|Secondary|Change From Baseline in log10 D-dimer After 1 and 4 Weeks|Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.|Baseline and at 1 week and 4 weeks|Full Analysis Set (FAS)|||ratio||Standard Deviation|Geometric Mean
2786031|NCT00621855|Secondary|Number of Participants With Any Reduction of D-dimer Concentration||at 1 week and 4 weeks|Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available.|||participants|||Number
2786032|NCT00621855|Secondary|Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment|Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
2786033|NCT00621855|Secondary|Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment|Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment|6 month treatment period + 2 week post treatment follow up|Treated set|||participants|||Number
2786034|NCT00621855|Primary|Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set - The treated set includes all patients who received at least one dose of study medication.|||participants|||Number
2786035|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
2786036|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
2786037|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)|The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2786038|NCT00621842|Secondary|Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2786039|NCT00621842|Secondary|Number of Participants Who Fell at Least Once During the Study||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
2786040|NCT00621842|Secondary|Change in Body Weight From Baseline||12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||lbs.||95% Confidence Interval|Mean
2786041|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2789808|NCT00594958|Secondary|Safety|Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability|study duration|||||||
2786042|NCT00621842|Secondary|Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2786043|NCT00621842|Secondary|Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2786044|NCT00621842|Secondary|Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)|The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2786045|NCT00621842|Secondary|Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)|Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.|12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.|||participants|||Number
2786046|NCT00621842|Primary|Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.|||units on a scale||95% Confidence Interval|Mean
2786047|NCT00621777|Secondary|Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder as Measured by the 12-Item Short Form Health Survey (SF-12)|The 12-Item Short Form Health Survey (SF-12) is a 12-item measure of perceived health status with good reliability, validity and correlation with other health measures. It is scored via a standard algorithm, with higher scores indicating better patient self perception of health, with a mean score of 50 and a standard deviation of 10 in a representative sample of the US population. The score is computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health. This was administered at baseline and end of study.|at week 52||||units on a scale||Standard Deviation|Mean
2786048|NCT00621777|Secondary|Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking as Assessed by the Brief Psychiatric Rating Scale|Brief Psychiatric Rating Scale is a 24 item scale that is designed to assess positive and negative symptoms, and general psychopathology in people with serious mental illness. Each item is rated on a 7-point scale from not present to extremely severe; higher scores in a range of 24 to 168, indicate more severe symptoms Ratings are based on observation and patient report. The validity of the BPRS is generally high when compared with other measures of general psychopathology. It was administered at baseline, study weeks 12, 18, 26, 38, 52|at week 52|Only 63 subjects completed study visit #52, therefore only these subjects were analyzed at this time point for this variable|||units on a scale||Standard Deviation|Mean
2786049|NCT00621777|Primary|Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group||76 weeks||||participants|||Number
2786050|NCT00621764|Other Pre-specified|Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2786051|NCT00621764|Other Pre-specified|Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.|||Participants|||Number
2786052|NCT00621764|Secondary|Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2786053|NCT00621764|Secondary|Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2786068|NCT00621530|Secondary|McGill Affective Pain|Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the emotional component of their pain experience. This is termed the McGill Pain Affective Score and is scored from 0 to 12 with 12 being the highest pain emotional impact.|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
2786054|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.~2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.|||Participants|||Number
2786055|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.~2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
2786056|NCT00621686|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.|Time from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years||||months||95% Confidence Interval|Median
2786057|NCT00621686|Secondary|Time to Progression|Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|Time from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years||||months||95% Confidence Interval|Median
2786058|NCT00621686|Primary|6-month Progression-free Survival|Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|at 6 months||||proportion of participants||95% Confidence Interval|Number
2786059|NCT00621621|Secondary|AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.||After 250 subjects have been enrolled.||||participants||95% Confidence Interval|Number
2786060|NCT00621621|Primary|Device or Procedure Related AV Block Persistent Through Discharge From Hospital.||After 250 subjects have been enrolled.||||participants||95% Confidence Interval|Number
2786061|NCT00621582|Secondary|Physician Tolerability Assessment at Visit 3|The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)|8 weeks (Visit 3)|Full Analysis Set (FAS)|||Participants|||Number
2786062|NCT00621582|Primary|Patient Tolerability Assessment at Visit 3|"Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good"|8 weeks (Visit 3)|Full Analysis Set (FAS)|||Participants|||Number
2786063|NCT00621582|Secondary|Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8;~Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks)"|2 weeks (Visit 2 and 8 weeks (Visit 3)||||Participants|||Number
2786064|NCT00621582|Primary|Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least).~Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks)"|0 weeks (Visit 1) and 8 weeks (Visit 3)|Sampling Method: Non-Probability Sample; conducted in primary care clinics.|||Participants|||Number
2786065|NCT00621543|Secondary|Percentage of Women Continuing IUD Use at 3 Months||3 months||||percentage of participants||95% Confidence Interval|Mean
2786066|NCT00621543|Primary|Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.||Three months||||percentage of participants||95% Confidence Interval|Mean
2786067|NCT00621530|Secondary|Neuropathic Pain Symptom Inventory|Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire to assess the degree of neuropathic characteristics of pain. This is termed the Neuropathic Pain Symptom Inventory which is scored 0-100 with 100 being the worst possible pain.|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
2786069|NCT00621530|Secondary|McGill Pain Intensity|Pain was assessed 2 days and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the intensity of their pain experience. This is termed the McGill Pain Intensity Score and is scored from 0 to 33 with 33 being the highest pain intensity.|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
2786070|NCT00621530|Secondary|Present Pain Intensity|Pain was assessed preoperatively, 2 days, and 2 and 6 months after surgery using a 0-10 (10 being worse) verbal Present Pain Intensity (PPI) scale|6 months|Some subjects were missed to follow up at different times|||units on a scale||Standard Deviation|Mean
2786071|NCT00621530|Primary|Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery|Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.|48 hours|These are data from the 57 subjects who remained in the study at the time of the primary outcome measure 48 hr after surgery|||area in centimeters squared||Full Range|Median
2786072|NCT00621517|Primary|Ordinal Scale (i.e., 1-8) of Symptom Severity||three weeks and six weeks|Once we started recruiting patients, we had decided not to do this outcome so this data was not obtained.||||||
2786073|NCT00621517|Primary|Clinical Global Impression - Improvement Scale||three weeks and six weeks|Once we started recruiting patients, we had decided not to do this outcome so this data was not obtained.||||||
2786074|NCT00621517|Primary|Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.|Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.|Baseline, three weeks, and six weeks|Intention to Treat|||points on a scale||Standard Deviation|Mean
2786075|NCT00621504|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit|||||||
2786076|NCT00621504|Secondary|Microbiological Re-infection/Recurrence at LFU||21 to 35 days after last dose of study drug|||||||
2786077|NCT00621504|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug|||||||
2786078|NCT00621504|Secondary|Clinical Relapse at Late Follow Up (LFU)||21-35 days after last dose of study drug|||||||
2786079|NCT00621504|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug|||||||
2786080|NCT00621504|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)||8-15 days after last day of study drug|||||||
2786081|NCT00621504|Secondary|Microbiological Success Rate at Test of Cure (TOC)||8-15 days after last dose of study drug|||||||
2786082|NCT00621504|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration|||||||
2786083|NCT00621504|Primary|Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary~Failure: Any of the following:~Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy~Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia~Death wherein pneumonia (ie,CABP) was considered causative~Indeterminate: Inability to determine an outcome"|8 to 15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.|||participants|||Number
2786084|NCT00621348|Secondary|Incidence of Symptomatic Hypernatremia|Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.|72 hrs|Intention to Treat analysis|||participants|||Number
2786085|NCT00621348|Secondary|Incidence of Symptomatic Hyponatremia|Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.|72 hrs||||participants|||Number
2786086|NCT00621348|Secondary|Incidence of Hypernatremia (Serum Sodium >150 mmol/L)||72 hrs|Intention To Treat analysis|||participants|||Number
2786087|NCT00621348|Primary|Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)||72 hrs|432 patients were eligible. 203 patients were excluded and 62 patients declined consent . Out of 167 patients, 58 patients were randomized to Arm 1, 53 to arm 2 and 56 to arm 3.Intention to treat analysis was used.|||participants|||Number
2786088|NCT00621322|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2786089|NCT00621322|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
2786101|NCT00621296|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration||24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.||||participants|||Number
2789904|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts||12 weeks after last treatment|ITT population|||lesions||95% Confidence Interval|Least Squares Mean
2786090|NCT00621322|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
2786091|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786092|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786093|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786094|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786095|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786096|NCT00621322|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786097|NCT00621322|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786098|NCT00621322|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms included fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786099|NCT00621322|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Subjects|||Number
2786100|NCT00621309|Primary|Midazolam Clearance (Pharmacokinetic Measure of Cytochrome P450 3A4 Activity)||7 days||||ng*min/ml||Standard Deviation|Mean
2813308|NCT00429364|Secondary|Number of Participants With Aortic Dissection.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
2786102|NCT00621257|Secondary|Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.|12 months||||Participants|||Count of Participants
2786103|NCT00621257|Primary|Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|"Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.~25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores."|6 weeks||||ng/ml||Standard Deviation|Mean
2786104|NCT00621244|Secondary|Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)|All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))|Post dose to pre-dose (up to 3.5 years)|Full Analysis Set (with available samples for analysis)|||Percent Change||Standard Deviation|Mean
2786105|NCT00621244|Secondary|Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)|All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))|Post dose to pre-dose (up to 3.5 years)|Full Analysis Set (with available samples for analysis)|||Percent Change||Standard Deviation|Mean
2786106|NCT00621244|Secondary|Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y||Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)|Full Analysis Set|||Percentages of participants|||Number
2786107|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X||Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)|Full Analysis Set|||Percentages of participants|||Number
2786108|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y||Days 5, 8, end of study (up to 3.5 years)|Full Analysis Set|||Percentages of participants|||Number
2786109|NCT00621244|Secondary|Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X|Reporting the number of patients with a reading at the timepoint in the dose group.|Days 1, 5, 8, 10, 15|Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group.|||Percentages of participants|||Number
2786110|NCT00621244|Secondary|Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1|MWF Every week schedule n = number of subjects with non-missing values.|Day 15/day 1|Pharmacokinetic set|||Ratio||90% Confidence Interval|Geometric Mean
2786111|NCT00621244|Secondary|Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15||Day 15|Pharmacokinetic set|||hour||Standard Deviation|Mean
2786112|NCT00621244|Secondary|Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15|From day 15 by dose with schedule: MWF every week|Day 15|Pharmacokinetic set|||ng/mL||Standard Deviation|Mean
2786113|NCT00621244|Secondary|Half Life of Panobinostat After the First Dose in Arms 1 and 2||Day 1|Pharmacokinetic set|||hour||Standard Deviation|Mean
2786114|NCT00621244|Secondary|Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2||Day 1|Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample.|||ng/mL||Standard Deviation|Mean
2786115|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)|Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.|3.5 years|Full Analysis Set|||Participants|||Number
2786116|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)|Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.|3.5 years|Full Analysis Set|||Participants|||Number
2786117|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase|Stage 2 did not open for enrollment.|1.2 years|Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.|||Participants|||Number
2786118|NCT00621244|Secondary|Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)|Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.|3.5 years|Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.|||Participants|||Number
2786119|NCT00621244|Primary|Number of Participants DLT in Arm 2 in Dose Escalation Phase|"Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly).~A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD."|Cycle 1 (28-day treamtent cycle)|MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.|||Participants|||Number
2786120|NCT00621244|Primary|Number of Participants DLT in Arm 1 in Dose Escalation Phase|Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.|Cycle 1 (28-day treatment cycle)|MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.|||Participants|||Number
2786121|NCT00621192|Primary|Key Safety Endpoints|Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure|Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug)|Safety Population - The Safety Population includes all patients who receive any amount of meropenem.|||Participants|||Number
2786122|NCT00621192|Primary|Meropenem Clearance|"Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, PK-odd and PK-even based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule."|Up to 7-8hrs post drug administration||||L/h/kg||Standard Deviation|Mean
2786123|NCT00621192|Primary|Deaths||Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)|The Safety Population includes all patients who receive any amount of meropenem.|||Participants|||Number
2786124|NCT00621192|Primary|Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)|"The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth.~Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1~If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure.~GA stands for Gestational Age and PNA stands for Postnatal Age."|Average of 12 days (3 to 21 days)|The Efficacy Population includes all patients who have efficacy assessment (Clinical Signs) at Pre-Dose and Study Day 28 (or the day that the Day 28 assessments were taken).|||Participants|||Number
2786125|NCT00621153|Secondary|Compliance Levels at 4 Weeks and 8 Weeks of Therapy|Percent of the number of returened pills to the number of prescrited pills|8 weeks|||||||
2786126|NCT00621153|Secondary|Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)|Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks|8 weeks|||||||
2786127|NCT00621153|Secondary|Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy|Change of hs-CRP from basline after 8 weeks|8 weeks|||||||
2786128|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy|Changed SBP from baseline after 8 weeks|8 weeks|||||||
2786129|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy|Percent of patients achieving goal of DBP|8 weeks|||||||
2786130|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy|Percent of the patients achieving goal DBP and SBP after 4 weeks|4 weeks|||||||
2786131|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy|Mean of the changed SBP from baseline after 4 weeks|4 weeks|||||||
2786132|NCT00621153|Primary|Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy|Mean of the changed DBP from baseline after 4 weeks|4 weeks||||mmHg||Standard Deviation|Least Squares Mean
2786133|NCT00621140|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Mean
2786134|NCT00621140|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2786135|NCT00621140|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||Percentage of Patients|||Number
2786136|NCT00621140|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%.|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2786137|NCT00621140|Secondary|Percentage of Patients With HbA1c<7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2786138|NCT00621140|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2786139|NCT00621140|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2786140|NCT00621140|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2786141|NCT00621140|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2786142|NCT00621140|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2786143|NCT00621140|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2786144|NCT00621140|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2786145|NCT00621140|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2786146|NCT00621140|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2786147|NCT00621049|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months||||months||95% Confidence Interval|Median
2786148|NCT00621049|Secondary|2-year Survival|Proportion of patients known to still be alive 2 years after coming on study|24 months||||percentage of participants|||Number
2786149|NCT00621049|Secondary|Safety|Adverse Events occuring in >15% of patients|2 years||||participants|||Number
2786150|NCT00621049|Primary|Disease-free Survival|The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.|1 year||||months||95% Confidence Interval|Median
2786151|NCT00621023|Secondary|Number of Patients With an Unacceptable Toxicity|Any of the following non-hematologic toxicities that causes a patient's therapy to be suspended or discontinued: Creatinine > 2x baseline value; serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), Total bilirubin > 2x the upper limit of normal; Febrile neutropenia; Uncontrolled infection; Hepatotoxicity defined as an increase in serum bilirubin, SGOT, or alkaline phosphatase to >5 times baseline value); nephrotoxicity (defined as serum creatinine >3.5 times the ULN); neurological impairment (defined as somnolence, seizures, or impaired mentation); severe peripheral neuropathy, or any non-hematologic grade 4 toxic event.|During the treatment period and for 30 days after last dose of study drug||||participants|||Number
2786152|NCT00621023|Secondary|Duration of a Complete or Partial Response Based on Number of People Who Responded.|Number of months a complete or partial response was maintained.|Up to 5 years or until death|||||||
2786153|NCT00621023|Primary|Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR)|Complete response and Partial response are defined using 2000 international working group (IWG) criteria. The Primary criteria for a CR is a repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia . A PR meets all the CR criteria except Blasts decreased by >50% over pretreatment, or a less advanced myelodysplastic syndrome (MDS) French American British (FAB) classification than pretreatment.|after 4 cycles of therapy||||participants|||Number
2786154|NCT00620945|Secondary|Mortality|Percentage of patients who died within 30 days of the procedure|30 days||||Participants|||Count of Participants
2786155|NCT00620945|Primary|Number of Participants Achieving High Flow Low Pressure on Cardiopulmonary Bypass|Percentage of patients who achieved high flow, low pressure on cardiopulmonary bypass|From time of cardiopulmonary bypass initiation until the time that high flow, low pressure on cardiopulmonary bypass was achieved, assessed up to 1 hour||||Participants|||Count of Participants
2786269|NCT00620061|Secondary|Mean Weekly Complete SBMs by Month|Participants rate each SBM as complete if their bowels feel completely empty after the SBM|Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the time point|||Weekly Complete SBMs||Standard Deviation|Mean
2786156|NCT00620854|Primary|Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)|This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB|Per protocol, only subjects who completed all 3 treatments were analyzed.|||% Change in Baseline CTx-1||Standard Error|Mean
2786157|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise|Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals|4 hours, 8 hours, 12 hours and 24 hours post-op||||participants|||Number
2786158|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion|Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort|24 hours post-op||||degrees||Standard Deviation|Mean
2786159|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance|Ambulation distance walked by participants 24-hours post-operatively|24 hours post-op||||Feet||Standard Deviation|Median
2786160|NCT00620828|Secondary|Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption|The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.|4 hours to 24 hours post-op||||micrograms||Standard Deviation|Mean
2786161|NCT00620828|Primary|Numeric Pain Score|Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).|Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection|per protocol|||units on a scale||Standard Deviation|Mean
2786162|NCT00620815|Secondary|Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit|"Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with:~Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)].~The change in frequency of T-cells was measured."|Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)|Analysis was done on full analysis set|||Mean cells per million total cells||95% Confidence Interval|Mean
2786163|NCT00620815|Secondary|Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.|"The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects.~Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC."|Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)|The analysis was done on Full analysis set|||Percentages of B-cell antibodies||95% Confidence Interval|Mean
2786164|NCT00620815|Secondary|Antibody Response Determined by HI and MN Assay.|Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay.|Up to 43 days|The population was analyzed on Per protocol set|||titers||95% Confidence Interval|Mean
2786165|NCT00620815|Secondary|Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2|Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay.|Up to 43 days|The analysis was done on Per Protocol Set|||Percentages of subjects||95% Confidence Interval|Number
2786166|NCT00620815|Secondary|Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain|"Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion.~Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH.~Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH)"|up to day 43|The population was analyzed on per protocol set.|||Percentage of subjects||95% Confidence Interval|Number
2786167|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.|Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|7 days after 1st and 2nd vaccinations each|The analysis was performed on Per Protocol Safety Population|||Participants|||Number
2786168|NCT00620815|Secondary|Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|Up to 7 days after 2nd vaccination|The analysis was performed on Safety Population|||Participants|||Number
2786169|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently.|Up to 7 days after 1st vaccination|The analysis was performed on Safety Population|||Participants|||Number
2786170|NCT00620815|Primary|To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.|"The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence.~The statistical analysis was done based on the GMRs."|up to day 43|The analysis was done on Per Protocol Set (PPS)|||Area (mm^2)||95% Confidence Interval|Geometric Mean
2786171|NCT00620776|Secondary|50 Percent or Greater Reduction in PSWQ Score|"Clinically significant change was defined on the PSWQ as an estimated (based on linear mixed effects model) endpoint score of less than 50.9. This score was calculated using the PSWQ normative data provided by Gillis, Haaga, and Ford (1995) and the baseline PSWQ mean and standard deviation (SD) from the current sample. The PSWQ mean and SD from the normative and current GAD samples were entered into the Jacobson et al. (1984) formula c for clinically significant change. This method provides a cutoff indicating whether or not the level of functioning by a patient is statistically more likely to be in the functional rather than the dysfunctional population."|Data collected as part of protocol 709012 at baseline, week 12, and week 24||||Participants|||Count of Participants
2786172|NCT00620776|Secondary|Clinical Response Rate|Clinical response on the HAM-A was defined as a 50% or greater reduction from baseline to last value with the 24-week open label medication phase.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24||||Participants|||Count of Participants
2786173|NCT00620776|Secondary|Mental Component Score of the 12-item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786174|NCT00620776|Secondary|Physical Component Score of the 12-Item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786175|NCT00620776|Secondary|Penn State Worry Questionnaire (PSWQ)|The Penn State Worry Questionaire is a 16-item inventory that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). A total score is calculated (range = 16 to 80), with higher scores indicating greater worry.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786176|NCT00620776|Secondary|Quality of Life Subscale of the General Health Questionnaire (GHQ)|The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. Patients completed the 12 quality of life questions (each on a 0 to 3 scale) on this questionnaire. Scores on the 12 items were added up to create summary score (range = 0 to 36). Higher scores indicate worse health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786177|NCT00620776|Secondary|Clinical Global Impression (CGI)-Improvement Score|The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale (1= very much improved; 7 = very much worse) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at different time points varies due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786178|NCT00620776|Secondary|Clinical Global Impression (CGI)-Severity Score|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (1=normal; 7 = extremely ill) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at each time point differs due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786179|NCT00620776|Secondary|Hamilton Rating Scale for Depression (HAM-D)-17-item Score|The 17-item version of the HAM-D was used to assess severity of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.The total score is the sum of the 17 items, with a range from 0 to 50. A higher scores indicates greater depression. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Numbers analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786180|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Depression Score|The HAD was used to assess patients' report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater depression.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786181|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Anxiety Score|The HAD was used to assess patients' report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater anxiety.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786182|NCT00620776|Primary|Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate and 25-30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at various time points differ due to patient dropout.|||units on a scale||Standard Deviation|Mean
2786183|NCT00620763|Primary|Calcium Absorption|After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.|18 weeks|Analysis included only the 16 volunteers that completed both dietary interventions.|||percentage of Calcium-47 absorbed||Standard Error|Mean
2786184|NCT00620750|Primary|Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections||4 months|Per protocol|||Percent of participants|||Number
2786185|NCT00620711|Primary|Cap Cooled to 12 Degrees Without Reducing Rectal Temperature|Yes/no|6 hours||||participants|||Number
2786186|NCT00620711|Primary|Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.|Measurement of number of participants able to obtain 12 degree cap temperature|60 minutes intervals up to 72 hours|all analysized|||participants|||Number
2786187|NCT00620698|Secondary|Handheld Dynamometry|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months||||Coefficient of variation||95% Confidence Interval|Mean
2786188|NCT00620698|Secondary|ALS Functional Rating Scale|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months||||Coefficient of variation||95% Confidence Interval|Mean
2786189|NCT00620698|Primary|Electrical Impedance Myography|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months||||Coefficient of Variation||95% Confidence Interval|Mean
2786190|NCT00620659|Secondary|Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo|"The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 (would never dose) to 3 (high chance of dozing). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse)."|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||units on a scale||Standard Error|Least Squares Mean
2786191|NCT00620659|Secondary|Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo|Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||units on a scale||Standard Error|Least Squares Mean
2786192|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||Minutes||Standard Error|Least Squares Mean
2786480|NCT00619112|Secondary|Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System|PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.|prior to start of study||||Participants|||Count of Participants
2786193|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||Minutes||Standard Error|Least Squares Mean
2786194|NCT00620659|Primary|Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.|||Minutes||Standard Error|Least Squares Mean
2786195|NCT00620555|Secondary|Percent Change in Seizure Frequency|Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."|||Percent change||Full Range|Median
2786196|NCT00620555|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."|||Percentage of participants||95% Confidence Interval|Number
2786197|NCT00620555|Secondary|Response Ratio|The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."|||Ratio||Standard Deviation|Mean
2786198|NCT00620555|Primary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|up to 53 weeks|Safety analysis set: All paticipants who have received at least one dose of the study drug.|||Participants|||Number
2786199|NCT00620542|Secondary|VLDL-C During the 104 Week Treatment Period|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786200|NCT00620542|Secondary|Apoliprotein B/Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
2786201|NCT00620542|Secondary|Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786202|NCT00620542|Secondary|Apolipoprotein B Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786203|NCT00620542|Secondary|Non-HDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
2786204|NCT00620542|Secondary|Total Cholesterol/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
2786205|NCT00620542|Secondary|LDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Ratio||Standard Error|Least Squares Mean
2786206|NCT00620542|Secondary|Non-HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786207|NCT00620542|Secondary|Triglycerides Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786208|NCT00620542|Secondary|HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786209|NCT00620542|Secondary|LDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786210|NCT00620542|Secondary|Total Cholesterol Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mg/dL||Standard Error|Least Squares Mean
2786211|NCT00620542|Secondary|Numbers of Patients Showing Regression in TAV|Regression defined as a change from baseline in TAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Participants|||Number
2786212|NCT00620542|Secondary|Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)|Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||mm^3||95% Confidence Interval|Median
2786213|NCT00620542|Secondary|Numbers of Patients Showing Regression in PAV|Regression defined as a change from baseline in PAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Participants|||Number
2786214|NCT00620542|Primary|Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)|"Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:~[sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD."|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).|||Percent change||95% Confidence Interval|Median
2786215|NCT00620503|Primary|Terminal Elimination Half-life (T1/2) of Proellex|Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.|24 hours|All 12 participants in the Safety population are included in the Intent-to-Treat (ITT) population.|||Hours||Standard Deviation|Mean
2786216|NCT00620503|Primary|AUC0-infinity of Proellex|Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration|24 hours|All 12 participants in the Safety population are included in the Intent-to-Treat (ITT) population.|||ng/mL*hour||Standard Deviation|Mean
2786217|NCT00620503|Primary|Tmax|Time to maximum plasma occurrence of Cmax|24 hours|All 12 participants in the Safety population are included in the Intent-to-Treat (ITT) population.|||Hours||Standard Deviation|Mean
2786218|NCT00620503|Primary|AUC0-last of Proellex|Area under the plasma concentration curve from time 0 (AUC0-last) to the last measurable plasma concentration time point, up to 24 hours.|Up to 24 hours|ITT and Safety populations are the same|||ng/mL*hour||Standard Deviation|Mean
2786219|NCT00620503|Primary|Cmax of Proellex|Maximum observed concentration (Cmax) of a single dose of Proellex® (25 mg) Formulation A using two different formulations of the drug in healthy adult female subjects with or without fasting|24 hours||||ng/mL||Standard Deviation|Mean
2786220|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon|"Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.~Cmax (pg/mL): Peak concentration."|3 years|All-Subjects-Pharmacokinetically-Evaluable consisted of 103 subjects.Subjects excluded from PK evaluation due to age, use of by protocol prohibited steroidal medication during trial and contraceptives within one week prior to Implanon insertion and their pre-insertion ENG concentration was not proven to be below Lower Limit Of Quantification (LLOQ)|||pg/mL||Full Range|Mean
2786481|NCT00619112|Secondary|Overall Survival||up to 2 years after treatment||||weeks||95% Confidence Interval|Median
2786221|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon.|"Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.~AUC0-6months (Area under the curve from zero to six months).~AUC0-24months (Area under the curve from zero to 24 months).~AUC0-36months (Area under the curve from zero to 36 months)."|3 years|103 subjects were pharmacokinetically evaluable. Subjects were excluded from PK evaluation for use of protocol-prohibited steroidal medication during the trial or contraceptives within 1 week prior to Implanon insertion, or because their pre-insertion ENG concentration was not proven to be below the Lower Limit of Quantification (LLOQ)|||pg•month/mL||Full Range|Mean
2786222|NCT00620425|Primary|The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).|Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.|-15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose||||injections|Participants||Number
2786223|NCT00620373|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||percentage of participants||95% Confidence Interval|Number
2786224|NCT00620373|Secondary|Specificity|Specificity measures the proportion of negatives which are correctly identified as such.|12 month after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging). The number of participants negative for breast cancer was 936-11 = 925.|||number of true negatives|||Number
2786225|NCT00620373|Primary|Number of Participants With Cancer Diagnosis at 12 Months||12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||participants|||Number
2786226|NCT00620373|Secondary|Sensitivity|Sensitivity measures the proportion of actual positives which are correctly identified as such.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||number of cancers diagnosed|||Number
2786227|NCT00620373|Primary|Diagnostic Yield|Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).|||cancers per 1000 women screened||95% Confidence Interval|Number
2786228|NCT00620321|Other Pre-specified|Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up|Deaths due to progressive disease (PD) and unknown cause are not considered adverse events. Deaths due to PD and unknown cause occurring during the 21-day follow-up period after treatment discontinuation are reported here and for those occurring while participants were on treatment are reported in the Participant Flow. Deaths due to serious adverse events occurred during the study including the 21-day follow-up period are reported in the Reported Adverse Events section.|Study treatment discontinuation up to 21 days post study treatment discontinuation|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2786229|NCT00620321|Secondary|Change From Baseline in Survivin Index at Day 2|Data presented are the ratio of Day 2 survivin index to the baseline survivin index. Survivin is a protein expressed in tumor cells, including acute myeloid leukemia (AML), which regulates mitosis and prevents tumor cell death. Survivin index was calculated as ([blast survivin mean equivalent fluorochrome (MEFL) - blast isotypic control MEFL]/blast isotypic control MEFL).|Baseline, Day 2|All participants who received at least one dose of study drug and had both baseline and Day 2 survivin index measurements. Per protocol amendment, only participants in LY2181308 arm were analyzed for Survivin Index.|||ratio||90% Confidence Interval|Least Squares Mean
2786230|NCT00620321|Secondary|Pharmacodynamics: Number of Participants With Survivin Protein Expression|Pharmacodynamics: Number of participants with Survivin Protein Expression.|6 Months|All participants who received at least one dose of study drug. Per protocol amendment, Survivin Protein Expression change was assessed for LY2181308 arm only.|||Participants|||Count of Participants
2786231|NCT00620321|Secondary|Area Under the Curve of LY2181308 Over the Dosing Interval|Area under the curve of LY2181308 over the dosing interval|Day 3: 0,12,24,36,48,60,72,84,96,108,120,132 hours|All participants who received study drug and had pharmacokinetic (PK) data to calculate AUC.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2786232|NCT00620321|Secondary|Relapse-Free Survival|Relapse-Free Survival was defined as the time from first objective status assessment of complete remission (CR) or CR with incomplete blood count recovery (CRi) or partial remission (PR) or cytoreduction to the first time of disease progression or death as a result of any cause. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). There were too few participants who had a documented progression of disease or death event amongst the participants with a response of CR, CRi, PR or cytoreduction to conduct the time-to-event analysis, thus the relapse-free survival was not analyzed.|Baseline to progression of disease or death up to 6 months|Zero participants analyzed as no data collected on participants for relapse free survival due to no sufficient follow up on participants with response for time to event.||||||
2786270|NCT00620061|Secondary|Treatment Effectiveness by Month|"Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.~The highest and best score is 4."|Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the given time point|||score on a scale||Standard Deviation|Mean
2786233|NCT00620321|Secondary|Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates)|Response is complete remission (CR) + CR with incomplete blood count recovery (CRi) + partial remission (PR) + cytoreduction. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). Response rate is calculated as a total number of participants with CR or CRi or PR or cytoreduction divided by the total number of participants treated multiplied by 100.|Baseline to progression of disease or death up to 6 months|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2786234|NCT00620321|Primary|Number of Participants With Adverse Events (Safety Profile)|Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section.|Start of treatment to study completion up to 6.7 months|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2786235|NCT00620282|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.|||episodes|||Number
2786236|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range|Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.|||participants|||Number
2786237|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range|Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.|||participants|||Number
2786238|NCT00620282|Secondary|Biomarkers of Cardiovascular Risk - Change in TNF-alpha|Change in TNF-alpha|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||pg/mL||Standard Error|Least Squares Mean
2786239|NCT00620282|Secondary|Fasting Lipid Profile - Change in Triglycerides (TG)|Change in TG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
2786240|NCT00620282|Secondary|Fasting Lipid Profile - Change in HDL-C|Change in HDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
2786241|NCT00620282|Secondary|Fasting Lipid Profile - Change in LDL-C|Change in LDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
2786242|NCT00620282|Secondary|Fasting Lipid Profile - Change in Total Cholesterol (TC)|Change in TC|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
2786243|NCT00620282|Secondary|Change in Body Weight||week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||kg||Standard Error|Least Squares Mean
2786244|NCT00620282|Secondary|Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles|The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
2786245|NCT00620282|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in FPG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mg/dL||Standard Error|Least Squares Mean
2786246|NCT00620282|Secondary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Percentage point change in HbA1c|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
2786247|NCT00620282|Secondary|Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mL/100 mL/min||Standard Error|Least Squares Mean
2786248|NCT00620282|Primary|Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.|||mL/100 mL/min||Standard Error|Least Squares Mean
2786249|NCT00620126|Primary|Percentage of Participants Adherent to Therapy|"Adherence was assessed using the Morisky Medication Adherence Score, a 4 item survey in which participants self-report medication-taking behavior. Each question that is answered with a No receives a score of 1. The possible scoring range is therefore 0 to 4. Higher scores correlate with better medical adherence. For the purpose of evaluating percent of participants adherent to therapy, the variable was dichotomized to Adherent or Non-adherent. Any response of Yes to one of the 4 items was scored as Non-Adherent."|12 Months||||Percentage of Participants|||Number
2786250|NCT00620126|Primary|Quality of Life (IBDQ)|Disease-specific quality of life was assessed using the IBD questionnaire (IBDQ). Scores for the IBDQ range from 32 to 224 with higher scores being associated with better quality of life. Score changes of 16 have been found to be significant changes when compared to baseline values.|12 Months||||Units||Standard Deviation|Mean
2786251|NCT00620126|Primary|Clinical Disease Activity (Seo Index)|Clinical disease activity was assessed using the Seo index. An activity index <120 represents clinical remission, whereas scores of 121-150, 151-220, and >221 correlate with mild, moderate, and severe disease respectively. The Seo index is sensitive to change, with a decrease in the index of 35 correlating with a clinical response.|12 months||||Units||Standard Deviation|Mean
2786252|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s- P1NP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-P1NP data.|||percent change||95% Confidence Interval|Least Squares Mean
2786253|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level|s-BSAP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s-BSAP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-BSAP data.|||percent change||95% Confidence Interval|Least Squares Mean
2786254|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)|The u-DPD/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-DPD/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-DPD/Cre data.|||percent change||95% Confidence Interval|Least Squares Mean
2786255|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. Blood samples were collected in the morning and in fasting state for measurement of s-CTx. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|PP Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available s-CTx data.|||percent change||95% Confidence Interval|Least Squares Mean
2786256|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio|The u-NTx/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-NTx/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed.|Baseline (Wk 0), Week 52|Per Protocol (PP) Population: All randomized participants receiving at least one dose of study medication, who complied with the protocol (excludes participants with major protocol violation), and with available u-NTx/Cre data.|||percent change||95% Confidence Interval|Least Squares Mean
2786257|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Trochanter BMD|BMD (g/cm2) data was measured by DXA at the trochanter subregion of the hip (near bony protrusions along outside edge of femur) at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment trochanter BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
2786258|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Femoral Neck BMD|BMD (g/cm2) data was measured by DXA at the femoral neck subregion of the hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment femoral neck BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
2786259|NCT00620113|Primary|Number of Participants That Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.|From first dose up to end of treatment (up to 52 weeks)|Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.|||participants|||Number
2786260|NCT00620113|Primary|Number of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.|From first dose up to Post-Study (up to 54 weeks)|Safety Population: All randomized participants receiving at least one dose of correct study medication. One participant received both 25 mg and 50 mg doses and was excluded from all analyses.|||participants|||Number
2786261|NCT00620113|Secondary|Percent Change From Baseline to Week 52 in Total Hip BMD|BMD (g/cm2) data was measured by DXA for total hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|FAS: All randomized participants receiving at least one dose of study medication and with necessary on-treatment total hip BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
2786262|NCT00620113|Primary|Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)|BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.|Baseline (Observation visit to Wk 0 treatment visit), Week 52|Full Analysis Set (FAS): All randomized participants receiving at least one dose of study medication and with necessary on-treatment lumbar spine BMD measurements, with data carried forward.|||percent change||95% Confidence Interval|Least Squares Mean
2786263|NCT00620074|Secondary|Voriconazole Trough Levels With Intravenous and Oral Dosing|Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).|Week 1 through Week 6|ITT; only 1 pharmacokinetic sample was collected for each subject, therefore a comprehensive analysis of trough plasma concentrations was not completed due to insufficient data.|||ng/mL||Standard Deviation|Mean
2786264|NCT00620074|Secondary|Galactomannan Titer Assay Levels and Global Response|Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Up to Week 6|ITT. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.|||participants|||Number
2786265|NCT00620074|Secondary|Summary of Mortality|Number of subects with documented mortality (death).|Up to Week 6|ITT|||participants|||Number
2786266|NCT00620074|Secondary|Summary of Global Response at Week 2, Week 4, and Week 6|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Week 2, Week 4, Week 6|ITT; due to low study enrollment, data not summarized by global response at Week 2, Week 4, and Week 6. Cross-reference outcome measure: Summary of Global Response at End of Treatment (EOT).|||participants|||Number
2786267|NCT00620074|Primary|Summary of Global Response at End of Treatment (EOT)|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|End of Treatment (Day 42)|Intent-to-treat (ITT): includes all subjects who received at least 1 dose of study medication. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.|||participants|||Number
2786268|NCT00620061|Secondary|Mean Weekly Complete BMs by Month|Participants rate each BM as complete if their bowels feel completely empty after the BM|Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the time point|||Weekly Complete BMs||Standard Deviation|Mean
2786272|NCT00620061|Secondary|Abdominal Discomfort by Month|"Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.~The highest score is 4, but the best score is 0."|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the given time point|||score on a scale||Standard Deviation|Mean
2786273|NCT00620061|Secondary|Abdominal Bloating by Month|"Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.~The highest score is 4, but the best score is 0."|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the given time point|||score on a scale||Standard Deviation|Mean
2786274|NCT00620061|Secondary|Constipation Severity by Month|"Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.~The highest score is 4, but the best score is 0."|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable scores at the given time point|||score on a scale||Standard Deviation|Mean
2786275|NCT00620061|Secondary|Stool Consistency of Spontaneous Bowel Movements by Month|Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the given time point|||score on a scale||Standard Deviation|Mean
2786276|NCT00620061|Secondary|Straining Associated With Spontaneous Bowel Movements by Month|Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat with evaluable data at the given time point|||score on a scale||Standard Deviation|Mean
2786277|NCT00620061|Secondary|Number of Participants Classified as Monthly Responders|"A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).~A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder."|Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat|||Participants|||Count of Participants
2786278|NCT00620061|Primary|Mean Weekly Bowel Movements (BMs) Per Month|A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat population with evaluable BM data during the given month|||Weekly BMs||Standard Deviation|Mean
2786279|NCT00620061|Primary|Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month|A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Intent-to-treat population with evaluable SBM data during the given month|||Weekly SBMs||Standard Deviation|Mean
2786280|NCT00620035|Primary|Implant Removal Time (Seconds)|The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.|||Seconds||Standard Deviation|Mean
2786281|NCT00620035|Primary|Implant Insertion Time (Seconds)|The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.|||Seconds||Standard Deviation|Mean
2786282|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
2786283|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
2786284|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator & the implant. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
2786285|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
2786313|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2786286|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects|In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.|||Percentage of Applicator Users|||Number
2786287|NCT00620022|Secondary|Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose|At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified-intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.|||Liters||Standard Error|Least Squares Mean
2786288|NCT00620022|Primary|Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period|At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.|||Seconds||Standard Error|Least Squares Mean
2786289|NCT00619983|Primary|Visual Analog Scale for Pain|"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as No pain at all and on the right as The worst pain imaginable. The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone)."|Study completion (16 weeks)|As noted in patient flow, data are available for only 14 of 22 subjects due to failure of the electronic daily diaries used to assess pain during the study and to study discontinuation in some cases|||units on a scale||Full Range|Median
2786290|NCT00619970|Primary|Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment||baseline (week 0) and at 2 weeks post treatment|1 patient from the treatment group withdrew from the study. Four additional children, 2 from the treatment group and 2 from the placebo group, did not show up for their follow up breath test|||Participants|||Count of Participants
2786291|NCT00619970|Primary|The Number of Participants at Baseline With SIBO||upon enrollment||||Participants|||Count of Participants
2786292|NCT00619957|Secondary|Cumulative Incidence of Fractures, 24 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years|Baseline to Month 24|ITT Population|||Fractures / 100 patients / 2 years|||Number
2786293|NCT00619957|Secondary|Cumulative Incidence of Fractures, 12 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year|Baseline to Month 12|ITT Population|||Fractures / 100 patients / year|||Number
2786294|NCT00619957|Secondary|Percent of Responders Lumbar Spine BMD, Month 24, ITT Population|responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24|Baseline to Month 24|ITT Population|||Percentage of Participants|||Number
2786295|NCT00619957|Secondary|Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||millimeters||95% Confidence Interval|Least Squares Mean
2786296|NCT00619957|Secondary|Change From Baseline in Body Height, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||millimeters||95% Confidence Interval|Least Squares Mean
2786297|NCT00619957|Secondary|Change From Baseline in Body Height, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||millimeters||95% Confidence Interval|Least Squares Mean
2786298|NCT00619957|Secondary|Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2786299|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||percent||95% Confidence Interval|Least Squares Mean
2786300|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786301|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 6, ITT Population.||Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786302|NCT00619957|Secondary|Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.||Baseline to Month 3|ITT Population|||percent||95% Confidence Interval|Least Squares Mean
2786303|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2786304|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.||Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786305|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.||Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786306|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.||Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786307|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.||Baseline to Month 3|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786314|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786315|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786316|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786317|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2786318|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786319|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786320|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786321|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2786322|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786323|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786324|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786325|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786326|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786327|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 6|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2786328|NCT00619957|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)|||Percent Change||95% Confidence Interval|Least Squares Mean
2786329|NCT00619918|Secondary|Supplemental Medication Use||14 days|||||||
2786330|NCT00619918|Secondary|IV Fluid Use||14 days|||||||
2786331|NCT00619918|Secondary|Hours of Oxygen Use||14 days|||||||
2786332|NCT00619918|Primary|Change in RDAI Score||1 day|||||||
2786334|NCT00619918|Primary|Admission Rate|Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.|1 day||||participants|||Number
2786335|NCT00619892|Secondary|Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).|Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM‑A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.|Comparing baseline and the end of 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
2786336|NCT00619892|Primary|Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores|Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.|Baseline and the end of 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
2786337|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24|Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and Week 24|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 24.|||percent change||Standard Deviation|Mean
2786338|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12|Bone mineral density (BMD) of the spine was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 12.|||percent change||Standard Deviation|Mean
2786339|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24|Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and Week 24|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 24.|||percent change||Standard Deviation|Mean
2786340|NCT00619866|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12|Bone mineral density (BMD) of the femur (total hip) was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and with available BMD data at baseline and week 12.|||percent change||Standard Deviation|Mean
2786341|NCT00619866|Secondary|Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image with five response categories for each item (Never, Rarely, Sometimes, Often, Always)~A supplemental questionnaire consisting of six additional questions which assess the areas of work, relationship with children, sexual intercourse, feelings about the medical profession, treatment, and infertility with the same five response categories plus an additional response category of Not Relevant which was not scored.~The scores associated with each possible outcome category are as follows: never (0), rarely (25), sometimes (50), often (75), and always (100). A negative change from baseline score indicates improvement in quality of life."|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2786342|NCT00619866|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2786343|NCT00619866|Secondary|Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2786344|NCT00619866|Secondary|Patient Global Impression of Change at Weeks 4, 8 and 12|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Mean
2786369|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786345|NCT00619866|Secondary|Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories:~0 = Absent; No discomfort during sexual intercourse.~1 = Mild; I can tolerate the discomfort during sexual intercourse.~2 = Moderate; Intercourse is sometime interrupted due to pain.~3 = Severe; I prefer to avoid intercourse because of pain.~Not applicable. I am not sexually active for reasons other than my endometriosis symptoms."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786346|NCT00619866|Secondary|Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2786347|NCT00619866|Secondary|Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2786348|NCT00619866|Secondary|Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2786349|NCT00619866|Secondary|Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of participants||95% Confidence Interval|Number
2786350|NCT00619866|Secondary|Change From Baseline in the Percentage of Days of Narcotic Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2786351|NCT00619866|Secondary|Change From Baseline in the Percentage of Days of Prescription Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2786370|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|7 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786371|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786352|NCT00619866|Secondary|Change From Baseline in the Percentage of Days of Any Analgesic Use|"The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic.~The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of none)."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Least Squares Mean
2786353|NCT00619866|Secondary|Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment|"Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day in an e-Diary on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain.~The percentage of days a participant reported a value of zero (no pain) for the non-menstrual pelvic pain and dysmenorrhea total score was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2786354|NCT00619866|Secondary|Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:~Subject is not having her period~0 = No pain related to period~1 = Mild pain related to period; subject could not do some of the things she usually does~2 = Moderate pain related to period; subject could not do many of the things she usually does~= Severe pain related to period; subject could not do most of or all of the things she usually does.~The percentage of days a participant reported a value of zero (no pain) for dysmenorrhea was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2786355|NCT00619866|Secondary|Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:~0 = No pelvic pain~1 = Mild pelvic pain; subject could not do some of the things she usually does~2 = Moderate pelvic pain; subject could not do many of the things she usually does~3 = Severe pelvic pain; subject could not do most or all of the things she usually does.~The percentage of days a participant reported a value of zero (no pain) for non-menstrual pelvic pain was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2786356|NCT00619866|Secondary|Percentage of Days With No Pain Based on NRS|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The percentage of days a participant reported a value of zero (or no pain) for the NRS was calculated for the 4 weeks prior to each visit."|Baseline and weeks 4, 8 and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||percentage of days||Standard Error|Mean
2786357|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores|"Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary.~The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786372|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786373|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786633|NCT00617903|Secondary|Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
2786358|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Dysmenorrhea Score|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options:~Subject is not having her period~0 = No pain related to period~1 = Mild pain related to period; subject could not do some of the things she usually does~2 = Moderate pain related to period; subject could not do many of the things she usually does~3 = Severe pain related to period; subject could not do most of or all of the things she usually does.~The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786359|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score|"Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options:~0 = No pelvic pain~1 = Mild pelvic pain; subject could not do some of the things she usually does~2 = Moderate pelvic pain; subject could not do many of the things she usually does~3 = Severe pelvic pain; subject could not do most or all of the things she usually does.~The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786360|NCT00619866|Secondary|Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit."|Baseline and Weeks 4, 8, and 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786361|NCT00619866|Secondary|Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and weeks 4 and 8|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786362|NCT00619866|Primary|Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12|"The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day.~The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit."|Baseline and week 12|All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2786363|NCT00619827|Primary|Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours|The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.|4 months|The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product.|||Units on a scale (range: 0 to 18)||Standard Error|Mean
2786364|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [µmol/L]||Full Range|Median
2786365|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||millimole per liter [mmol/L]||Full Range|Median
2786366|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
2786367|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||unit per liter [U/L]||Full Range|Median
2786368|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||micromole per liter [µmol/L]||Full Range|Median
2786374|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786375|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed|||milliseconds||Standard Deviation|Mean
2786376|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2786377|NCT00619762|Primary|Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix|"Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of sparse or light distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %."|At the time of expander/implant exchange (Stage II),|All implanted patients enrolled in the study were included in the analysis|||percentage of breasts|Participants||Number
2786378|NCT00619762|Secondary|Severity of Local Inflammation at and Around the Surgical Site|The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation).|Postoperative Day 7, 14, 21, 30 days|Total breasts enrolled were 29. Day 7, N = 28 breasts available Day 14, N = 27 breasts available Day 21, N = 27 breasts available Day 30, N = 25 breasts available|||units on a scale|Participants|Standard Deviation|Mean
2786379|NCT00619723|Secondary|Manic Symptoms Measured Using Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) is a clinician-rated scale that has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. The total score is calculated by summing answers to all the item on the scale, with a higher score indicative of more severe mania symptoms. The scale total score ranges from 0 (absence of manic symptoms) to 60 (severe manic symptoms).|12 weeks||||units on a scale||Standard Deviation|Mean
2786380|NCT00619723|Secondary|Depressive Symptoms Measured Using the Hamilton Rating Scale for Depression (HRSD)|As part of HRSD, the patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52.|12 Weeks||||units on a scale||Standard Deviation|Mean
2786381|NCT00619723|Primary|Percentage of Participants With Presence of a Cocaine-Positive Urine Screen|Cocaine use frequency was measured by the presence or absence of a cocaine-positive urine screen. Drug screens were obtained thrice-weekly for 12 weeks. All participants who completed the baseline assessment and at least one additional assessment were included in the primary analysis. Missing data were imputed as cocaine positive.|12 weeks||||percentage of participants|||Number
2786382|NCT00619684|Secondary|Overall Survival|Kaplan-Meier estimate of survival|At 1 and 2 years after starting treatment with lenalidomide|Patients enrolled on trial who received lenalidomide therapy.|||percentage of participants||95% Confidence Interval|Number
2786383|NCT00619684|Secondary|TTP|"Time to Progression (TTP): Time from start of therapy to meeting the definition of Progressive Disease (PD).~PD: 25% increase compared to the lowest value of:~Serum MP (absolute increase at least ≥ 0.5 g/dl)~Or: Urine MP (absolute increase at least > 200 mg/24h)~Or: for patients without measurable MP, Serum Free Light Chain test: the difference between involved and uninvolved FLC levels (absolute increase at least >100 mg/L)"|Up to 9 years|Patients who developed Progressive Disease while on lenalidomide treatment|||Months||Full Range|Median
2786384|NCT00619684|Secondary|Number of Patients Who Experience Improvement in GVHD on Lenalidomide, Defined as the Reduction in Severity of GVHD as Defined by the National Institutes of Health (NIH) Consensus Criteria||Up to 9 years|Patients who received lenalidomide on study|||Participants|||Count of Participants
2786385|NCT00619684|Secondary|Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide|Dose interruption, dose reduction or discontinuation of lenalidomide due to toxicity, GVHD or disease progression|Up to 9 years|Patients enrolled on the trial who received lenalidomide treatment.|||Participants|||Count of Participants
2786386|NCT00619684|Secondary|Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Grade 1-2 adverse events occurring in >10% of participants. Grade 3 or higher adverse events occurring in one or more participants.|Up to 30 days after completion of study treatment||||percentage of participants|||Number
2786387|NCT00619684|Primary|Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)|"CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF < 0) AND < 5% plasma cells in bone marrow aspirate.~VGPR: More than 90% decrease of MP and urine M protein < 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive.~PR: Over 50% decrease of serum MP AND > 90% reduction in 24h urinary light chain excretion or M proteinuria < 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria>200 mg/d)"|Up to 9 years||||Participants|||Count of Participants
2786390|NCT00619645|Primary|Number of Patients With Day 100 Transplant-related Mortality|Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.|24 months after day 100 transplant||||Participants|||Count of Participants
2786391|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.|||percentage of participants|||Number
2786392|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.|||(ng*hr/mL)/mg of dose|||Number
2786393|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.|||(ng*hr/mL)/mg of dose|||Number
2786394|NCT00619619|Primary|Area Under the Curve From Time Zero to Infinity (AUC0-∞)|AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population|||ng*hr/mL||Standard Deviation|Mean
2786395|NCT00619619|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population|||hr||Standard Deviation|Mean
2786396|NCT00619619|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population|||hr||Standard Deviation|Mean
2786397|NCT00619619|Primary|Maximum Observed Plasma Concentration (Cmax)|Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.|||ng/mL||Standard Deviation|Mean
2786398|NCT00619619|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline to Follow-up (up to Day 77)|Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.|||participants|||Number
2786399|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-S score of 6 or 7, therefore only scores 1 through 5 are reported.|||percentage of participants|||Number
2786400|NCT00619619|Other Pre-specified|Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT|||Score on a scale||Standard Deviation|Mean
2786555|NCT00618618|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT subset|||participants|||Number
2786401|NCT00619619|Other Pre-specified|Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.|||scores on a scale||Standard Deviation|Mean
2786402|NCT00619515|Secondary|Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices||Survey at 1,6,12 months and yearly up to 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786403|NCT00619515|Secondary|Rate of Distant Failure||Assessed at months 3,6,12,18,24 and every 12 months through 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786404|NCT00619515|Secondary|Rate of Local Failure||Assessed at months 3,6,12,18,24 and every 12 months through 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786405|NCT00619515|Secondary|Overall Survival||Assessed yearly for 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786406|NCT00619515|Secondary|Disease-specific Survival||Assessed yearly for 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786407|NCT00619515|Secondary|Disease-free Survival (Phoenix and ASTRO Definitions)||Assessed yearly for 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786408|NCT00619515|Secondary|Biochemical Disease-free Survival|PSA|Assessed at months 3,6,12,18,24 and every 6 months through 5 years|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786409|NCT00619515|Secondary|Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0|Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions.|Within 5 years of completing treatment|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786410|NCT00619515|Primary|Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0|This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.|Within 90 days of completing treatment|The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2786411|NCT00619502|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable."|Day 0 up to Day 7 post-booster vaccination|Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP~T according to the primary series received (Safety Analysis Population).|||Participants|||Number
2786412|NCT00619502|Primary|Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).|Day 0 before and Day 30 post-booster vaccination|GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2786413|NCT00619502|Primary|Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™|Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.|Day 0 before and Day 30 Post-booster vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.|||Percentage of Participants|||Number
2786482|NCT00619112|Secondary|Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.|Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.|First day of treatment until progression or until 6 months mark|Tumor tissue was available for the exploratory MGMT methylation analysis in 48 patients. In 7 samples the tissue was inadequate for analysis.|||weeks||95% Confidence Interval|Median
2786414|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.|||percent MADCAM binding||Standard Deviation|Mean
2786415|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.|||% ACT1 binding||Standard Deviation|Mean
2786416|NCT00619489|Secondary|Serum Concentration of Vedolizumab Before Dosing|Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy.|Days 43, 99, 155 and 267, predose|"The PK Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PK parameters. Participants without dose modification and with available serum concentration data at each time point (indicated by n) are included."|||μg/mL||Standard Deviation|Mean
2786417|NCT00619489|Primary|Number of Participants With Human Anti-human Antibodies (HAHA)||Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.|Safety analysis set|||participants|||Number
2786418|NCT00619489|Primary|Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)|At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.|through Day 637|Safety analysis set|||participants|||Number
2786419|NCT00619489|Primary|Number of Participants With Clinically Significant Laboratory Findings|Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.|through Day 637|Safety analysis set|||participants|||Number
2786420|NCT00619489|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.~The intensity for each AE was defined according to the following criteria:~Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities."|From Day 1 to Day 637|Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.|||participants|||Number
2786421|NCT00619476|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The CGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.|||participants|||Number
2786422|NCT00619476|Secondary|Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||points on a scale||Standard Error|Least Squares Mean
2786483|NCT00619112|Primary|6 Month Progression-free Survival|Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival|First day of treatment until progression or until 6 months mark||||percentage of patients||95% Confidence Interval|Number
2790100|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2786423|NCT00619476|Secondary|Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||points on a scale||Standard Error|Least Squares Mean
2786424|NCT00619476|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.|||points on a scale||Standard Error|Least Squares Mean
2786425|NCT00619476|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (Week 13 or early withdrawal)|ITT Population. There was one participant in the GEn 1200 mg and two in the GEn 2400 mg group who did not have enough data available to calculate the rescue mediation consumed while on treatment.|||milligrams||Standard Error|Least Squares Mean
2786426|NCT00619476|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as the first day of event minus the last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Anytime post-baseline until date of last dose of study medication (up to Week 13)|ITT Population|||days||Full Range|Median
2786427|NCT00619476|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg and one in the GEn 2400 mg group who did not have enough data available to calculate the percent reduction.|||participants|||Number
2786428|NCT00619476|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The PGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.|||participants|||Number
2786429|NCT00619476|Secondary|Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data|Dynamic allodynia (pain in response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) was assessed by an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NRS analysis included a subset of the ITT Population who completed that NRS at both the Baseline and the Week13/Withdrawal Visit.|||points on a scale||Standard Error|Least Squares Mean
2786430|NCT00619476|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The SF-MPQ analysis included a subset of the ITT Population who completed a SF-MPQ assessment at both Baseline and the Week 13/Withdrawal Visit.|||points on a scale||Standard Error|Least Squares Mean
2786522|NCT00618774|Secondary|Seated Blood Pressure Normalisation at Trough|"Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:~Optimal: SBP <120 mmHg and DBP <80 mmHg~Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg~High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg~No: SBP >=140 mmHg or DBP >=90 mmHg"|6 months and 12 months|FAS|||percentage of participants|||Number
2786431|NCT00619476|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NPS summary included a subset of the ITT Population that completed an NPS assessment at both Baseline and Week 13/Withdrawal.|||points on a scale||Standard Error|Least Squares Mean
2786432|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1220 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EOMT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786433|NCT00619476|Secondary|Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786434|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate an API for the EOMT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786435|NCT00619476|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate a score for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786436|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the participant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786437|NCT00619476|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786438|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline wss calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EOMT timepoint.|||points on a scale||Standard Error|Least Squares Mean
2786523|NCT00618774|Secondary|Seated SBP Response Rate at Trough|Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months|6 months and 12 months|FAS|||percentage of participants|||Number
2786439|NCT00619476|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as EOMT score minus Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population: all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement.|||points on a scale||Standard Error|Least Squares Mean
2786440|NCT00619385|Primary|AUC Post Final Dose||7 days||||hour*ng/mL||Standard Deviation|Mean
2786441|NCT00619385|Primary|Cmax Post Final Dose|To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.|7 days||||ng/mL||Standard Deviation|Mean
2786442|NCT00619359|Secondary|No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)|The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.|Overall (the 120 hours following initiation of cisplatin chemotherapy)|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis.|||Participants|||Number
2786443|NCT00619359|Secondary|A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.|Delayed phase (25 to 120 hours following initiation of cisplatin).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis.|||Participants|||Number
2786444|NCT00619359|Primary|A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.|Overall (in the 120 hours following initiation of cisplatin chemotherapy).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.|||Participants|||Number
2786445|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score|"This is defined as the sum of the scores for side effects section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome."|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
2786446|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score|"This is defined as the sum of the scores for the side effects section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome."|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
2786447|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score|"This is defined as the sum of the scores for the injection systems section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome."|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
2786448|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score|"This is defined as the sum of the scores for the injection systems section questions 1-9 and the side effects section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome."|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
2786449|NCT00619307|Primary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score|"This is defined as the sum of the scores for the side effects section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome."|4 weeks|ITT|||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
2786450|NCT00619255|Secondary|Number of Patients Experiencing High-Level Depressive Symptoms|The investigators used the Patient Health Questionnaire (PHQ-9) to identify symptoms consistent with a diagnosis of depression on the 9-item Patient Health Questionnaire depression screen. Scores range from 1 to 27 with higher scores representing worse outcomes.|Baseline (injury), then 2, 5, and 12 months post-injury||||Participants|||Count of Participants
2786451|NCT00619255|Secondary|Percentage of Adolescents Who Self-reported Weapon Carriage|Self-reported carrying of knife, gun, club or other weapon by adolescent|Baseline (injury), then 2, 5, and 12 months post-injury||||Participants|||Count of Participants
2786452|NCT00619255|Secondary|Percentage of Asolescents Linked to Primary Care During the Study|Percentage of adolescents self-reporting one or more primary care visits over the course of the 12-months after the injury|Up to12 months post-injury||||Participants|||Count of Participants
2786453|NCT00619255|Secondary|Number of Patients Who Self-reported Alcohol Consumption or Drug Use|Any self-reported alcohol or drug use using one yes or no question|Baseline (injury), and 2, 5, and 12 months post-injury||||Participants|||Count of Participants
2786504|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||mm Hg||Standard Error|Mean
2786454|NCT00619255|Primary|Number of Patients With High Levels of Adolescent PTSD Symptoms|"Patients with symptoms consistent with a diagnosis of PTSD on the UCLA PTSD Reaction Index were counted. The UCLA PTSD-RI can be used to create an algorithm consistent with a diagnosis of PTSD by rating 1 intrusive, 3 avoidant, and 2 arousal symptoms with a rating of moderate severity. The PTSD-RI is scored on a scale from 0 (none of the time) - 4 (most of the time) with a > = 2 some of the time denoting this cutoff for moderate severity. This algorithm was used to identify patients with high PTSD symptom levels consistent with a diagnosis of PTSD."|Baseline (injury), then 2, 5, and 12 months post-injury||||Participants|||Count of Participants
2786455|NCT00619242|Primary|Ki-67|Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.|Two weeks|The 3 subjects underwent therapy without complications however the study was terminated due to low accrual.||||||
2786456|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 6 months|Full Analysis Set (FAS)|||Participants|||Number
2786457|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 3 months|Full Analysis Set (FAS)|||Participants|||Number
2786458|NCT00619229|Secondary|The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to time immediately after intervention|Full Analysis Set (FAS)|||Participants|||Number
2786459|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 6 months|Full Analysis Set (FAS)|||Unit on a scale||Standard Deviation|Mean
2786460|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 3 months|Full Analysis Set (FAS)|||Unit on a scale||Standard Deviation|Mean
2786461|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to time immediately after intervention|Full Analysis Set (FAS)|||Unit on a scale||Standard Deviation|Mean
2786462|NCT00619229|Secondary|Development of a Wet Age-related Macular Degeneration|"A wet age-related macular degeneration (AMD) is defined as the development of choroidal neovascularization of the study-eye (worse eye).~Development is categorized in Yes and No, where Yes means that a subject who had no wet AMD at Screening has developed a wet AMD at Week 29."|From baseline to 6 months|Full Analysis Set (FAS)|||Participants|||Number
2786463|NCT00619229|Secondary|Progression of the Dry Age-related Macular Degeneration|"Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as~Progression~Stabilization~Amelioration"|From baseline to 6 months|Full Analysis Set (FAS)|||Participants|||Number
2786464|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 6 months|Full Analysis Set (FAS)|||Lines read in ETDRS chart||Standard Deviation|Mean
2786465|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to time immediately after intervention|Full Analysis Set (FAS)|||Lines read in ETDRS chart||Standard Deviation|Mean
2786505|NCT00618839|Secondary|Viability of Allograft Tissues|Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.|At the time of allograft removal (~7 days)|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.|||Ki67 positive cells/ total cells||Full Range|Median
2786524|NCT00618774|Secondary|Seated DBP Response Rate at Trough|Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months|6 months and 12 months|FAS|||percentage of participants|||Number
2786466|NCT00619229|Primary|Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 3 months|Full Analysis Set (FAS)|||Lines read in ETDRS chart||Standard Deviation|Mean
2786467|NCT00619190|Secondary|Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks|The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.|||units on a scale||Standard Deviation|Mean
2786468|NCT00619190|Primary|Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks|The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.|Baseline to 12 weeks|Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.|||units on a scale||Standard Deviation|Mean
2786469|NCT00619190|Secondary|Clinical Global Impressions Scale - Severity Score (CGI-S)|"One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients)."|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.|||units on a scale||Standard Deviation|Mean
2786470|NCT00619177|Secondary|Physician Assessment of Efficacy|"Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.~The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy.|||Participants|||Number
2786471|NCT00619177|Secondary|Patient Assessment of Efficacy|"Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.~The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy.|||Participants|||Number
2786472|NCT00619177|Secondary|Change From Baseline of Pain Intensity on Visual Analogue Scale|The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)|Approximately four weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on pain intensity on VAS at baseline and final visit.|||Units on a scale||Standard Deviation|Mean
2786473|NCT00619177|Primary|Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2|Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|Baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).|||Units on a scale||Standard Deviation|Mean
2786474|NCT00619177|Primary|Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.|Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).|||Units on a scale||Standard Deviation|Mean
2786475|NCT00619151|Primary|Aortic Mean Gradient|Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.|6 months|Analysis not performed due to study termination prior to analysis period.|||mmHg||Standard Deviation|Mean
2786476|NCT00619151|Primary|Effective Orifice Area (EOA)|Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.|6 month evaluation|Analysis not performed due to study termination prior to analysis period.|||cm^2||Standard Deviation|Mean
2786484|NCT00619099|Primary|The Overall Improvement Rate|"Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement.~Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Remission: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.~Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%.~Marrow Complete Remission: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.~HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response."|Up to one year|Modified Intent to Treat (mITT) Population|||Percentage of Participants|||Number
2786485|NCT00619073|Primary|Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.|Value at 45 days after intervention minus value at baseline in platelet surface activated GPIIb-IIIa complex using flow cytometry.The types and concentrations of agonists used in the flow cytometry assays reported here were: ADP 0.5, 1, and 20 µmol/L; thrombin receptor activating peptide (TRAP) 1 and 20 µmol/L; and a combination of collagen 5 µg/mL and epinephrine 5 µmol/L. Mean Florescence Intensity (MFI) is used as unit of measure. MFI indicates relative degree of shift in fluorescence intensity of a population of platelets in arbitrary units.|Baseline and 45 days after intervention||||mean fluorescence intensity (MFI)||Standard Error|Mean
2786486|NCT00619060|Primary|Participants With Adverse Events by Treatment.|Comparison of number of participants with adverse events by treatment.|30 Days||||participants|||Number
2786487|NCT00618995|Secondary|Prostaglandin I Metabolite (PGI-M)|PGI-M in the Overall 24 Hour Collection Interval Following Administration on Day 7|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
2786488|NCT00618995|Primary|Urinary 11-Dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
2786489|NCT00618982|Other Pre-specified|Disease Control - mITT Population|Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.|||Participants|||Number
2786490|NCT00618982|Other Pre-specified|Tumor Response - mITT Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.|||Participants|||Number
2786491|NCT00618982|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to treat (ITT).|||months||95% Confidence Interval|Median
2786492|NCT00618982|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to-treat (ITT).|||months||95% Confidence Interval|Median
2786493|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax)|Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated.|||hours||Full Range|Median
2786494|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax)|Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2786495|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)|AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2786496|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)|AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2786497|NCT00618982|Primary|Tumor Response - ITT (Intent to Treat) Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline.|||participants|||Number
2786498|NCT00618982|Primary|Best Response - mITT (Modified Intent-to-treat) Population|Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.|||Participants|||Number
2786499|NCT00618956|Secondary|Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6|Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||bpm||Standard Error|Mean
2786500|NCT00618956|Secondary|Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4|Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||bpm||Standard Error|Mean
2786501|NCT00618956|Secondary|Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||mm Hg||Standard Error|Mean
2786502|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach|||mm Hg||Standard Error|Mean
2786503|NCT00618956|Secondary|Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.|||mm Hg||Standard Error|Mean
2786506|NCT00618839|Secondary|Appearance of Allograft Tissues|The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).|StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.|||points||Standard Error|Mean
2786507|NCT00618839|Primary|Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.|The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.|two weeks post-autografting|Intrapatient treatment sites were randomized such that each half of the wound site received StrataGraft and the other half received cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.|||Percent Area of Autograft Take (%)||Standard Deviation|Mean
2786508|NCT00618826|Other Pre-specified|Toxicity|toxicities recorded using CTCAE definitions|Duration of study|||||||
2786509|NCT00618826|Other Pre-specified|Overall Survival (OS) at 3 Years|proportion of participants surviving 3 years|3 years|||||||
2786510|NCT00618826|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|maximum 50 months|patients with measurable disease|||proportion of participants||95% Confidence Interval|Number
2786511|NCT00618826|Primary|Progression-free Survival|Time from study entry to disease progression or death|maximum 50 months||||months||95% Confidence Interval|Median
2786512|NCT00618813|Secondary|Event Free Survival|Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact.|From enrollment to event or 10 years from enrollment, whichever occurs first|||||||
2786513|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 29 to week 37|Two patients were not evaluated for DLT during weeks 29-37 because those patients did not complete that segment of protocol therapy.|||participants|||Number
2786514|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 23 to week 28|One patient was not evaluated for DLT during weeks 23-28 because the patient did not complete that segment of therapy.|||participants|||Number
2786515|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 13 to week 22|One patient was not evaluated for dose-limiting toxicity during weeks 13-22 because patient did not complete that segment of protocol therapy.|||participants|||Number
2786516|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Enrollment to week 12|Any patient who receives at least one cycle of protocol therapy, or who is removed from protocol therapy partly or solely because of a dose-limiting toxicity will be evaluable for this outcome.|||participants|||Number
2786517|NCT00618813|Primary|Incidence of Death|Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy|Length of protocol therapy (up to 37 weeks) plus 30 days|Any patient who receives at least one cycle of protocol therapy, or who dies as a result of complications of therapy prior to completing one cycle of therapy will be evaluable for this outcome|||participants|||Number
2786518|NCT00618787|Primary|Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.|At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.|Weeks 0 and 4|Per protocol|||Percentage change||Full Range|Median
2786519|NCT00618787|Secondary|Pain||5 weeks|||||||
2786520|NCT00618787|Primary|Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups||5 weeks|||||||
2786521|NCT00618774|Primary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|First administration of study treatment to 24 hours post last dosing of study treatment.|Treated set|||participants|||Number
2786527|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
2786528|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure|Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
2786529|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 8 Weeks|Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment|Week 8|FAS|||percentage of participants|||Number
2786530|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 8 Weeks|Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment|week 8|FAS|||percentage of participants|||Number
2786531|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
2786532|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.|||mmHg||Standard Deviation|Mean
2786533|NCT00618774|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|52 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.|||percentage of participants|||Number
2786534|NCT00618748|Secondary|Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval)|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||millisecond (msec)||Standard Deviation|Mean
2786535|NCT00618748|Secondary|Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||microgram/Liter||Standard Deviation|Mean
2786536|NCT00618748|Secondary|Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint|HbA1c is a test that measures the amount of glycated hemoglobin in the blood over prolonged periods of time.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2786537|NCT00618748|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48|EPS symptoms measured by DIEPSS are grouped into 4 categories: Parkinsonism, akathisia, dystonia, and dyskinesia. Severity ranges from level 0 (none, normal) to 4 (severe). A participant is deemed to have EPS at endpoint if they have an abnormal endpoint. Normal baseline Parkinsonism is defined as a score not ≥3 on 1 item or ≥2 on 2 items; abnormal endpoint is a score ≥3 on 1 item or ≥2 on 2 items, or an increase of 3 on Parkinsonism total. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score ≥2 or an increase ≥2 from that baseline score.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with a normal baseline and an endpoint result. For Parkinsonism, normal baseline is defined as a score not ≥3 on 1 item or ≥2 on 2 items. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2.|||percentage of participants|||Number
2786538|NCT00618748|Secondary|Percentage of Participants With High Suicidality at Week 24 or Week 48|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit value.|||percentage of participants|||Number
2786539|NCT00618748|Secondary|Percentage of Participants With Emergence of Mania at Week 24 or Week 48|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All Randomized participants.|||percentage of participants|||Number
2786540|NCT00618748|Secondary|Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The scores for mania, depression, and overall illness each range from 1 (normal, not ill) to 7 (very seriously ill).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2786541|NCT00618748|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2786542|NCT00618748|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2786543|NCT00618748|Secondary|Change From Baseline in Weight at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||kilograms||Standard Deviation|Mean
2786544|NCT00618748|Secondary|Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.|||millimole/Liter||Standard Deviation|Mean
2786545|NCT00618748|Primary|Percentage of Participants With Adverse Events Leading to Discontinuation|An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.|Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All randomized Participants.|||percentage of participants|||Number
2786546|NCT00618722|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT population|||participants|||Number
2786547|NCT00618722|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data|||degrees||Standard Deviation|Mean
2786548|NCT00618722|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:~1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT population with available data|||units on a scale||95% Confidence Interval|Least Squares Mean
2786549|NCT00618722|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.~0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.~Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population|||percentage of participants|||Number
2786550|NCT00618722|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data|||units on a scale||Standard Deviation|Mean
2786551|NCT00618722|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data|||units on a scale||Standard Deviation|Mean
2786552|NCT00618722|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.~Severity of adverse events was determined using the following scale:~Mild: The participant is aware of a sign or symptom, but it is easily tolerated~Moderate: Discomfort or interference with usual activity~Severe: Incapacitating, with inability to engage in usual activity.~A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:~was fatal~was life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~was a congenital anomaly/birth defect~other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety and Modified Intent to Treat (mITT) population including all randomized participants who received at least 1 dose of study drug and who had at least 1 post-baseline observation.|||participants|||Number
2786553|NCT00618618|Secondary|Visual Analogue Scale Pain Intensity Rating|Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)|Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12|"Safety/mITT subset with available data at each time point (indicated by N)"|||units on a scale||Standard Deviation|Mean
2786554|NCT00618618|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||degrees||Standard Deviation|Mean
2786571|NCT00618514|Secondary|Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.|6 Months||||Limbs|Participants||Number
2786556|NCT00618618|Secondary|Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset|||units on a scale||Standard Deviation|Mean
2786557|NCT00618618|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:~1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset|||units on a scale||Standard Deviation|Mean
2786558|NCT00618618|Secondary|Percentage of Participants With an SMF Response|Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||percentage of participants|||Number
2786559|NCT00618618|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.~0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.~Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||percentage of participants|||Number
2786560|NCT00618618|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|"The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||units on a scale||Standard Deviation|Mean
2786561|NCT00618618|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data|||units on a scale||Standard Deviation|Mean
2786562|NCT00618618|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.~Severity of adverse events was determined using the following scale:~Mild: The participant is aware of a sign or symptom, but it is easily tolerated~Moderate: Discomfort or interference with usual activity~Severe: Incapacitating, with inability to engage in usual activity.~A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:~was fatal~was life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~was a congenital anomaly/birth defect~other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/miTT subset|||participants|||Number
2786563|NCT00618540|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6||||participants|||Number
2786564|NCT00618540|Secondary|Platelet Engraftment|Incidence of platelet recovery and donor chimerism at Day 100.|Day 100||||participants|||Number
2786565|NCT00618540|Secondary|Incidence of Chronic GVHD|Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving > 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up.|Day 100 and Month 6||||participants|||Number
2786566|NCT00618540|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6||||participants|||Number
2786567|NCT00618540|Secondary|Neutrophil Engraftment|Incidence of neutrophil recovery and donor chimerism at Day 100.|Day 100||||participants|||Number
2786568|NCT00618540|Secondary|Transplantation-related Death|Count of patients who died by day 100 related to the transplantation.|Day 100||||participants|||Number
2786569|NCT00618540|Primary|Disease-free Survival at 12 Months Post Transplantation|"This outcome is defined as survival with resolution of LCH at 12 months post transplant.~Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events.~Those who survive with resolution of disease are censored at the date of last contact."|Year 1||||participants|||Number
2786570|NCT00618540|Primary|Overall Survival|Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact.|Year 1, Year 3||||participants|||Number
2816363|NCT00408993|Secondary|Number of Participants Discontinuing Due to Adverse Events||over 12 weeks|Intention to Treat Analysis. All randomized patients.|||participants|||Number
2786572|NCT00618514|Secondary|Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.|"Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as I am very satisfied with the laser treatment and the worse score of poor was defined as I am not satisfied with the laser treatment. Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point."|6 months||||Percentage of participants|Participants||Number
2786573|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.|Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point.|6 Months||||percentage of change|Participants|Standard Deviation|Mean
2786574|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).|VDS is a physician's evaluation of a patient's ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months||||percentage of change|Participants|Standard Deviation|Mean
2786575|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).|VCSS is a physician's evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months||||percentage change|Participants|Standard Deviation|Mean
2786576|NCT00618514|Primary|Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.|6 Months||||Limbs|Participants||Number
2786577|NCT00618514|Primary|Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.|The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.|6 Months||||Limbs|Participants||Number
2786578|NCT00618449|Primary|Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]||1-year post-treatment|Per protocol.|||Participants|||Number
2786579|NCT00618436|Secondary|Incidence of Adverse Events||discharge; 3 and 6 months following injury|||||||
2786580|NCT00618436|Secondary|Disability Rating Scale (DRS)|The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.|Discharge; 3 and 6 months following injury|All patients|||units on a scale||Full Range|Mean
2786581|NCT00618436|Secondary|Extended Glasgow Outcome Score|This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.|at discharge; 3 and 6 months following injury|All patients|||units on a scale||Full Range|Mean
2786582|NCT00618436|Primary|Seizure Incidence|This was the number of patients in each group who demonstrated seizure activity during the course of the study|Duration of study, up to 6 months after the injury||||Participants|||Number
2786583|NCT00618410|Secondary|Eosinophil Influx [Post-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|after antigen challenge||||percentage of white blood cells||Full Range|Median
2786584|NCT00618410|Secondary|Eosinophil Influx [Pre-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|before antigen challenge||||percentage of white blood cells||Full Range|Median
2786585|NCT00618410|Secondary|Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.~Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.~The number reported in this outcome measure was calculated by subtracting the contralateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||ng/mL||Full Range|Median
2816621|NCT00407654|Secondary|Overall Survival (Prior Bevacizumab Treated Group)|Kaplan-Meier method will be used (Bevacizumab-naïve Group)|12 months||||months||95% Confidence Interval|Median
2786586|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.~Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.~The number reported in this outcome measure was calculated by subtracting the ipsalateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||ng/mL||Full Range|Median
2786587|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Ipsilateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||milligrams||Full Range|Median
2786588|NCT00618410|Primary|Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Contralateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.|||milligrams||Full Range|Median
2786589|NCT00618371|Secondary|Proviral DNA Response, HIV-1 Sequence Variation Levels of Cell Associated HIV DNA and Genetic Variation in HIV During Raltegravir Addition in Individuals Who Have Declines in HIV|We planned to compare HIV DNA levels and HIV genetic variation in individuals with and without ≥10 fold decreases in HIV RNA. As none of the patients had a decline in viral RNA, this analysis could not be readily analyzed|4 weeks|0 participants were analyzed because no patients had ≥10 fold decrease in viral RNA. As described in patient outcome description, we would sequence patients only if a ≥10- fold decrease in viremia occurred, Since no one experienced ≥10 fold decrease in viremia, no sequencing could be performed.||||||
2786590|NCT00618371|Primary|Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load|HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA|4 weeks|Number of participants based on estimates of how many will have decreased viral RNA levels. If 10 participants do not have decreased RNA, the number of patients with potential for decrease is <15% of all suppressed patients.|||participants|||Number
2786591|NCT00618332|Secondary|Changes in RQLQ: Eye|The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786592|NCT00618332|Secondary|Changes in RQLQ: Emotional|The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|There were one patient in the Mometasone Furoate group with a missing value.|||units on a scale||Standard Deviation|Mean
2786593|NCT00618332|Secondary|Changes in RQLQ: Nasal|The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786594|NCT00618332|Secondary|Changes in RQLQ: Practical|The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786595|NCT00618332|Secondary|Changes in RQLQ: Non-Nasal/Eye|The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786596|NCT00618332|Secondary|Changes in RQLQ: Sleep|The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786597|NCT00618332|Secondary|Changes in RQLQ: Activity|The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786598|NCT00618332|Secondary|Changes in RQLQ: Overall|The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2786599|NCT00618332|Primary|Global Assessment|"Global Assessment: 3=significantly improved, 2=moderately improved,~1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse"|at week 2|There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values.|||units on a scale||Standard Deviation|Mean
2786600|NCT00618072|Secondary|Adiponectin|Total adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer.|6 months||||ug/mL||Standard Error|Mean
2786601|NCT00618072|Secondary|Triglycerides|Triglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents.|6 months||||mg/dl||Standard Error|Mean
2786608|NCT00618072|Primary|Fasting Insulin|Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.|6 months|The final data-set consisted of 44 study participants, after exclusion of two study completers due to clinical conditions which appeared de novo (asthma requiring high dose prednisone and growth hormone deficiency diagnosed mid-study) - applicable to all study outcomes.|||uIU/mL||Standard Error|Mean
2786609|NCT00617981|Secondary|Safety||3 years|||||||
2786610|NCT00617981|Secondary|Time to Local Recurrence.||3 years|||||||
2786611|NCT00617981|Secondary|Time to Definite Worsening as Per Patient-Reported Outcomes||3 years|||||||
2786612|NCT00617981|Secondary|Overall Survival as Measured by Time From Randomization to Death or the End of the Study.||3 years|||||||
2786613|NCT00617981|Primary|Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any Cause||3 years||||Time to Progression (months)||95% Confidence Interval|Number
2786614|NCT00617942|Secondary|Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity|Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment.|1 year||||participants|||Number
2786615|NCT00617942|Primary|Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;|These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.|1 year||||participants|||Number
2786616|NCT00617929|Secondary|Acute Graft-vs-host Disease|"Percent of patients with Acute Graft-vs-host Disease - a process where T-cells present in the donor's bone marrow at the time of transplant identify the transplant patient as non-self' and attack the patient's skin, liver, stomach, and/or intestines."|Day 30-100||||percentage of participants|||Number
2786617|NCT00617929|Secondary|Chimerism|Occurrence of genetically distinct cell types in a single organism|Day 28 post transplantation||||percentage of donor cells||Full Range|Median
2786618|NCT00617929|Secondary|Survival|Percent of patients alive from beginning of study to one year post transplantation|One year post transplantation||||percentage of participants|||Number
2786619|NCT00617929|Secondary|Time to Primary Neutrophil Engraftment|Time to primary neutrophil engraftment is defined as the percent of patients with an absolute neutrophil count (ANC) of 500 or more neutrophils in a cubic millimeter of blood.|Day 42 post transplantation||||percentage of participants|||Number
2786620|NCT00617929|Secondary|Treatment-related Death|Percent of patients who died related to the treatment in this study.|Day 100 post transplantation||||percentage of participants|||Number
2786621|NCT00617929|Primary|Survival at 100 Days Post Transplant|Percent of patients alive from beginning of study to Day 100 post transplantation|Day 100 post transplantation||||percentage of participants|||Number
2786622|NCT00617929|Primary|Rate of Sustained Donor Engraftment|Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection.|Day 42 post transplantation||||percentage of participants|||Number
2786623|NCT00617903|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)|IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
2786624|NCT00617903|Secondary|Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12|"IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).)."|At Weeks 4, 8 and 12||||Percentage of participants|||Number
2786625|NCT00617903|Secondary|Patients' Opinion on Cosmetic Acceptability at End of Study|Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases|||Percentage of participants|||Number
2786626|NCT00617903|Secondary|Patients' Rating of Overall Improvement at End of Study|Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases|||Percentage of participants|||Number
2786627|NCT00617903|Secondary|Investigator's Rating of Overall Improvement at End of Study|Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)|||Percentage of participants|||Number
2786628|NCT00617903|Secondary|Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
2786629|NCT00617903|Secondary|Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Scores on a scale||Standard Deviation|Mean
2786630|NCT00617903|Secondary|Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
2786631|NCT00617903|Secondary|Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12|Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe|Baseline and Weeks 4, 8 and 12||||Percentage of participants|||Number
2786632|NCT00617903|Secondary|Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Scores on a scale||Standard Deviation|Mean
2786634|NCT00617903|Secondary|Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Scores on a scale||Standard Deviation|Mean
2786635|NCT00617903|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At Weeks 4, 8, 12 and End of Study (LOCF)||||Percentage of participants|||Number
2786636|NCT00617903|Secondary|Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||Baseline and Weeks 4, 8, 12 and End of Study (LOCF)||||Percent change in Inflammatory lesions||Standard Deviation|Mean
2786637|NCT00617903|Secondary|Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12||Baseline and Weeks 4, 8 and 12||||Inflammatory lesions||Standard Deviation|Mean
2786638|NCT00617903|Secondary|Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)||||Inflammatory lesions||Standard Deviation|Mean
2786639|NCT00617903|Primary|Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)|Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe|Baseline and End of Study (Week 12)||||Percentage of participants|||Number
2786640|NCT00617903|Primary|Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At End of Study (Week 12)||||Percentage of participants|||Number
2786641|NCT00617903|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)||Baseline and End of Study (Week 12)||||Inflammatory lesions||Standard Deviation|Mean
2786642|NCT00617890|Secondary|Duration of Response (Groups 2 and 3 Only)|This is a measure of the amount of time in which the tumor responded to therapy.|From time of documented response until disease progression or data analysis cut off (Up to 3.4 years)|Group 2 and 3 participants; this outcome was not evaluated due to early termination of the study||||||
2786643|NCT00617890|Secondary|Overall Survival (Groups 2 and 3 Only)|This is a measure of the time of survival from first dose to documentation of death|From start of treatment until death or data analysis cut off (Up to 3.4 years)|Group 2 and 3 Participants|||Months||95% Confidence Interval|Median
2786644|NCT00617890|Secondary|Time to Disease Progression (Groups 2 and 3 Only)|This is a measure of the time from the start of the study to the time of documented disease progression.|From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years)|All participants in Groups 2 and 3; this outcome was not evaluated due to early termination of the study||||||
2786645|NCT00617890|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment.|Up to 2 years|All participants receiving study drug.|||Participants|||Number
2786646|NCT00617890|Secondary|Incidence of Anti-robatumumab Antibodies|For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab.|Up to 2 years|This outcome was not evaluated due to early termination of the study.||||||
2786647|NCT00617890|Secondary|Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only)||End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks)|Group 1, both dose levels: this outcome was not evaluated due to early termination of the study.||||||
2786648|NCT00617890|Secondary|Time Until Tumor Relapse (Group 1 Only)|This is a measure of the time from the start of the study to documented relapse of disease.|From start of treatment until relapse or data analysis cut off (Up to 3.4 years)|Group 1 participants; this outcome was not evaluated due to early termination of the study.||||||
2786649|NCT00617890|Secondary|Overall Survival|This is a measure of the number of participants known to be alive at the time of data analysis for this study.|From start of treatment until death or data analysis cut off (Up to 3.4 years)|All study participants|||Participants|||Number
2786650|NCT00617890|Primary|Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only)|Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Group 2 participants with evaluable data.|||Participants|||Number
2786651|NCT00617890|Primary|Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only)|Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation.|Approximately 14 days|Group 1 Participants; this outcome was not evaluated due to early termination of the study.||||||
2786652|NCT00617890|Primary|Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only)|This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Participants in Group 3 with evaluable data.|||Participants|||Number
2786663|NCT00617773|Other Pre-specified|12-Month Survival Rate|Rate of patients alive 12 months after starting therapy with the investigational product.|12 months from the start of study treatment.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||percentage of participants||95% Confidence Interval|Number
2786653|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain B)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||percentages of participants||95% Confidence Interval|Mean
2786654|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||percentages of participants||95% Confidence Interval|Mean
2786655|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||percentages of participants||95% Confidence Interval|Mean
2786656|NCT00617851|Secondary|Number of Subjects With at Least One Unsolicited Adverse Event|Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).|3 weeks after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.|||participants|||Number
2786657|NCT00617851|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms|Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.|7 days after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.|||Participants|||Number
2786658|NCT00617851|Secondary|Geometric Mean Titers (GMTs), by Vaccine Group and Strain|The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||titers||95% Confidence Interval|Geometric Mean
2786659|NCT00617851|Primary|Geometric Mean Titers (GMTs), by Vaccine Lots|The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"|||Titers||95% Confidence Interval|Geometric Mean
2786660|NCT00617773|Post-Hoc|Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.|||weeks||95% Confidence Interval|Median
2786661|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.|||weeks||95% Confidence Interval|Median
2786662|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Ascites at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||weeks||95% Confidence Interval|Median
2790124|NCT00593606|Primary|Change in Gamma-Glutamyltransferase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
2786664|NCT00617773|Other Pre-specified|Overall Survival|Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.|From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||weeks||Full Range|Median
2786665|NCT00617773|Other Pre-specified|Progression Free Survival (PFS)|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.|||weeks||Full Range|Median
2786666|NCT00617773|Other Pre-specified|Clinical Benefit|"The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.~Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.~The evaluation of target and non-target lesions is described at the Outcome Measure titled Best Overall Response. CR: Complete Response; PR: Partial Response; SD: Stable Disease."|From start of study treatment until the end of Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.|||percentage of participants||95% Confidence Interval|Number
2786667|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses|Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.|All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.|||µg/mL||Standard Deviation|Mean
2786668|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.|Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.|||µg/mL||Standard Deviation|Mean
2786669|NCT00617773|Secondary|Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).|Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.|From the first dose of investigational product up to 30 days after the last dose of investigational product||||participants|||Number
2786670|NCT00617773|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|A listing of all adverse events is located in the Reported Adverse Event module.|From the first dose of investigational product up to 30 days after the last dose of investigational product|All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.|||participants|||Number
2786671|NCT00617773|Primary|Best Overall Response|"Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).~Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.|||participants|||Number
2786672|NCT00617734|Secondary|Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab|No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay.|Biomarkers [pre-dose, Cycle 1 (Day 15), (Cycle 2 (Day 1), and end of treatment]; Immunogenicity [pre-dose, prior to first infusion for Cycle 3, Cycle 5, and 30-day safety follow-up]|No participants were analyzed due to lack of an appropriate validated assay.||||||
2786673|NCT00617734|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths|TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs including serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to 29.63 months)|Randomized participants who received at least 1 dose of study drug.|||participants|||Number
2786674|NCT00617734|Secondary|Duration of Response|The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of PD or death. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of PD.|Date of first response to the date of PD or death due to any cause (up to 23.98 months)|Randomized participants who received at least 1 dose of study drug and had CR or PR. No participants were censored for duration of response.|||months||95% Confidence Interval|Median
2786765|NCT00617305|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||mmHg||Standard Deviation|Mean
2786675|NCT00617734|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.|Baseline to date of death from any cause (up to 29.63 months)|Randomized participants who received at least 1 dose of study drug. Eleven (11) participants in IMC-A12 (Cixutumumab) group and 6 participants in IMC-A12 (Cixutumumab) + Cetuximab group were censored for analysis.|||months||95% Confidence Interval|Median
2786676|NCT00617734|Secondary|Percentage of Participants With PFS at 6 Months|PFS at 6 months was defined as the percentage of participants who have neither experienced PD nor died at 6 months after the date of randomization. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 6 months divided by the total number of participants treated then multiplied by 100.|6 months|Randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2786677|NCT00617734|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.|Baseline to measured PD (up to 27.66 months)|Randomized participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2786678|NCT00617734|Primary|Progression-Free Survival (PFS)|PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.|Baseline to measured PD (up to 27.66 months)|Randomized participants who received at least 1 dose of study drug. Seven (7) participants in IMC-A12 (Cixutumumab) and 4 participants in IMC-A12 (Cixutumumab) + Cetuximab were censored for analysis.|||months||95% Confidence Interval|Median
2786679|NCT00617708|Primary|Progression-Free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.|||months||95% Confidence Interval|Median
2786680|NCT00617708|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2786681|NCT00617708|Secondary|Response|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients in the Phase II portion of the study with measurable disease and adequate response assessment.|||percentage of participants||95% Confidence Interval|Number
2786682|NCT00617708|Primary|Maximum Tolerated Dose Determination|Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|28 days|Phase I patients receiving at least three doses of the assigned dose during Cycle 1 or whom developed a DLT.|||mg/kg IMC-A12|||Number
2786683|NCT00617708|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.|||months||95% Confidence Interval|Median
2786684|NCT00617669|Secondary|PSA Response|PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Participants|||Number
2786685|NCT00617669|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Months||Inter-Quartile Range|Median
2786686|NCT00617669|Secondary|Pain Response|Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.|||Participants|||Number
2786766|NCT00617305|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||mmHg||Standard Deviation|Mean
2786687|NCT00617669|Secondary|Time to Pain Progression|Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Months||Inter-Quartile Range|Median
2786688|NCT00617669|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)||||Months||Inter-Quartile Range|Median
2786689|NCT00617669|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set|||Months||Inter-Quartile Range|Median
2786690|NCT00617669|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Patients were followed for progression up to 40 months|Full Analysis Set|||Months||Inter-Quartile Range|Median
2786691|NCT00617669|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 40 months|Full Analysis Set|||Months||Inter-Quartile Range|Median
2786692|NCT00617604|Secondary|Number of Participants With Adverse Events|"Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.~A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:~Resulted in death.~Was life-threatening.~Resulted in persistent or significant disability/incapacity.~Resulted in congenital anomaly or birth defect.~Required patient hospitalization or led to prolongation of hospitalization~Was considered a medically important event.~All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE"|6 Months|Safety analysis set (all randomized participants who received at least one dose of study drug).|||participants|||Number
2786693|NCT00617604|Secondary|Percentage of Participants With Treatment Failure at Month 6|Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786694|NCT00617604|Secondary|Percentage of Participants With Delayed Graft Function|Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.|1 week|Full analysis set|||percentage of participants|||Number
2786695|NCT00617604|Secondary|Percentage of Participants With Efficacy Failure at Month 6|"Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.~The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786696|NCT00617604|Secondary|GFR Measured by Iothalamate Clearance at Month 6|GFR measured using the iothalamate clearance method and determined by a central laboratory.|Month 6|Full analysis set participants with available data|||mL/minute||Standard Deviation|Mean
2786697|NCT00617604|Secondary|Change From Month 1 in Creatinine Clearance|The creatinine clearance was calculated according to the Cockcroft-Gault formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by n)."|||mL/minute||Standard Deviation|Mean
2786698|NCT00617604|Secondary|Change From Month 1 in Glomerular Filtration Rate (GFR)|The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by n)."|||mL/min/1.73 m²||Standard Deviation|Mean
2786699|NCT00617604|Secondary|Change From Month 1 in Serum Creatinine||Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by n)."|||µmol/L||Standard Deviation|Mean
2786700|NCT00617604|Secondary|Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6|The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786751|NCT00617344|Secondary|Number of Participants With Solicited Systemic Reactions After Any Vaccination|Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: - Grade1: >=37.5°C to <=38.0°C (>=99.5°F to <=100.4°F), Grade 2: >38.0°C to <=39.0°C (>100.4°F to <= 102.2°F), Grade 3: >39.0°C (>102.2°F). Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.|14 days after any injection 1, 2 or 3|Analysis was performed on safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.|||Participants|||Count of Participants
2786701|NCT00617604|Secondary|Maximum Histological Grade of All Biopsies After Local Review|"The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.~Acute T-cell mediated rejection:~Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;~Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;~Grade IIA: mild to moderate intimal arteritis;~Grade IIB: severe intimal arteritis comprising >25% of the luminal area;~Grade III: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.~Acute antibody-mediated rejection:~Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;~Grade II: capillary-margination and/or thromboses, C4d+~Grade III: arterial - v3, C4d+."|6 months|Full analysis set|||percentage of participants|||Number
2786702|NCT00617604|Secondary|Graft Survival|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.~The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786703|NCT00617604|Secondary|Patient Survival|Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786704|NCT00617604|Secondary|Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6|"Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786705|NCT00617604|Secondary|Percentage of Participants With Steroid-resistant Acute Rejection at Month 6|"A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.~The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786706|NCT00617604|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6|Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786707|NCT00617604|Secondary|Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6|Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786708|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786709|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786710|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:~Acute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):~Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;~Grade II: capillary-margination and/or thromboses, C4d+~Grade III: arterial - v3, C4d+.~A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2786801|NCT00617201|Primary|% Urine Samples Negative for Cocaine|Total % urine samples negative for benzoylecgonine over the 12-week trial|Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks|Intent-to-treat analysis included all subjects with missing urine sample counted as positive.|||percentage of positive urine samples|Urine samples||Number
2786711|NCT00617604|Primary|Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:~Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;~Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;~Grade IIA: mild to moderate intimal arteritis;~Grade IIB: severe intimal arteritis comprising >25% of the luminal area;~Grade III: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.~A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug)|||percentage of participants||90% Confidence Interval|Number
2786712|NCT00617591|Secondary|Occurrence of Induction Toxicities|"Tolerability of full dose Revlimid® with full dose Doxil® in combination with reduced schedule dexamethasone was to be assessed during Cycle 1 and at the start of Cycle 2 using, whenever possible, the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0.~Due to increased neutropenia and fatigue, toxicities were reviewed after the first 29 participants were enrolled."|24 Months|First 29 participants with the PLD starting dose of PLD 40 mg/m^2, due to increased neutropenia and fatigue.|||percentage of participants|||Number
2786713|NCT00617591|Secondary|2 Year Overall Survival (OS) Rate|Percentage of participants with Overall Survival in response to Dd-R in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.|24 Months|All participants|||percentage of participants|||Number
2786714|NCT00617591|Secondary|Median Progression Free Survival (PFS) in Months|PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium > 11.5 mg/dl) attributable only to the plasma cell dyscrasia.|24 Months|All participants|||months||95% Confidence Interval|Median
2786715|NCT00617591|Primary|Percentage of Participants With Very Good Partial Remission (VGPR) or Better|Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction Dd-R as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants|||percentage of participants|||Number
2786716|NCT00617591|Primary|Overall Response Rate (ORR) - Percentage of Participants With Partial Response or Better With Induction Regimen|ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants|||percentage of participants|||Number
2786717|NCT00617539|Primary|Number of Patients Experiencing a Clinical Benefit|The number of patients experiencing a clinical benefit is the sum of patients with an objective response plus patients with stable disease at ≥ 16 weeks from cycle 1 day 1 (first day of treatment). If a patient did not come back for a follow up scan after clinical deterioration, then they were only considered stable up to the time of the last scan they had per protocol.|From 1 day 1 (first day of treatment) every 8 weeks until scan shows disease progression or up to 2 years||||Participants|||Count of Participants
2786718|NCT00617539|Secondary|Number of Patients Whose Circulating Tumor Cells (CTCs) Decreased From >5 to <5 CTCs Per 7.5 mL|CTCs were measured in blood using the Cellsearch(R) assay in 14 of the 20 patients measured at baseline|CTCs drawn on cycle 1 day 1, collection at 8 week intervals on patients who did not progress on their 8 week scans up to 2 years|Of 20 patients with CTCs measured at baseline, 14 were also measured at 8 weeks|||participants|||Number
2786719|NCT00617539|Secondary|Overall Time of Survival|Time from initiation of study participation until death|Time from initiation of study participation until death or up to 3 years||||Days||Full Range|Median
2786720|NCT00617539|Secondary|Time to First Progression in CNS|"Imaging at 8-week intervals to assess response to treatment. A modified RECIST 1.0 criteria was used to assess response and time to progression in the CNS for patients with progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.~If patient did not come back for a follow up scan after clinical deterioration, patient was only considered stable up to the time of the last scan per protocol and time to progression would be from cycle 1 day 1 to the last scan they completed that was stable."|Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years||||Days||Full Range|Median
2786721|NCT00617539|Primary|Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS|Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.|Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years||||Participants|||Count of Participants
2786722|NCT00617461|Secondary|Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations|"Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as Full Range. A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured."|A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period|Drug concentration data were available from 89 ITT Population participants. Data from 7 of these participants had one concentration with less than half of the first percentile of the concentrations observed at ss and were defined as non-compliant and were excluded from the pharmacokinetic (PK) analysis.|||micrograms per milliliter||Full Range|Geometric Mean
2786723|NCT00617461|Secondary|Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF|The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where scores range from 0 to 10 (0=no impact to 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and could thus not be included in the analysis.|||points on a scale||Standard Error|Least Squares Mean
2786724|NCT00617461|Secondary|Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for sleep interference during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786725|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response data to this questionnaire and could thus not be included in the analysis.|||participants|||Number
2786726|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response to this questionnaire and thus could not be included in the analysis.|||participants|||Number
2786727|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.|||participants|||Number
2786802|NCT00617188|Secondary|Urine N-telopeptide Concentration|Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.|Baseline, 1 Month, 3 Months, 6 Months||||Units of Bone Collagen Equivalents/mmol||Full Range|Median
2786728|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.|||participants|||Number
2786729|NCT00617461|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for rescue medication usage during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||milligrams||Standard Error|Least Squares Mean
2786730|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period|Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment score minus the baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.|||participants|||Number
2786731|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||participants|||Number
2786732|NCT00617461|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current morning pain during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786733|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786763|NCT00617305|Secondary|Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. An increase in measurement value (meters walked) indicates improvement for this patient population.|Baseline to Week 48|All enrolled Population|||meters walked||Standard Deviation|Mean
2816622|NCT00407654|Secondary|Overall Survival (Bevacizumab-naïve Group)|Kaplan-Meier method will be used. (Bevacizumab- naïve Group)|12 months||||months||95% Confidence Interval|Median
2786734|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF|Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786735|NCT00617461|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current evening pain during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786736|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786737|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786738|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. The by period summary is provided as a sensitivity analysis for the primary analysis.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24 hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.|||points on a scale||Standard Deviation|Mean
2786739|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as end of treatment minus baseline. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24-hour API assessments during the GEn 3600mg treatment period, and was therefore not included in this analysis.|||points on a scale||Standard Error|Least Squares Mean
2786740|NCT00617409|Secondary|Overall Survival (OS)|To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.|Up to 24 months|All participants.|||months||95% Confidence Interval|Median
2821313|NCT00373685|Secondary|Change From Baseline Hct at Week 24||Baseline and Week 24 or ET|ITT; N= number of evaluable participants analyzed; LOCF|||Percent||Standard Error|Least Squares Mean
2786741|NCT00617409|Primary|Tumor Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|12 months|All participants.|||participants|||Number
2786742|NCT00617396|Primary|Adequate Relief in Pain Score During Treatment|"Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.-  Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain."|8 weeks|There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.|||percentage of subjects|||Number
2786743|NCT00617357|Secondary|Activities Assessment Scale (AAS)|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity."|24 Months||||units on a scale||Standard Deviation|Mean
2786744|NCT00617357|Secondary|Activities Assessment Scale (AAS)|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity."|12 Months||||units on a scale||Standard Deviation|Mean
2786745|NCT00617357|Secondary|Activities Assessment Scale (AAS)|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity."|6 Months||||units on a scale||Standard Deviation|Mean
2786746|NCT00617357|Secondary|Activities Assessment Scale (AAS)|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity."|3 Months||||units on a scale||Standard Deviation|Mean
2786747|NCT00617357|Secondary|Activities Assessment Scale (AAS)|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity."|30 Days||||units on a scale||Standard Deviation|Mean
2786748|NCT00617357|Secondary|Activities Assessment Scale (AAS)|"The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from No difficulty to Not able to do it. The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity."|Baseline||||units on a scale||Standard Deviation|Mean
2786749|NCT00617357|Primary|Incidence of Wound Events|Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.|Postoperatively up to 24 months|80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.|||participants|||Number
2786750|NCT00617344|Secondary|Number of Participants With Vaccine Viremia|Vaccine viremia (level of vaccine virus in blood samples taken from participants) was measured by an assay yellow fever reverse transcriptase polymerase chain reaction which allowed the detection of vaccine viremia of any serotype (1, 2, 3 and 4).|7 days post-injection 1 and 2, 14 days post-injection 1 and 2|Analysis was performed on Viremia Analysis Set which included all participants who received study vaccination and provided at least one blood sample for which vaccine viremia laboratory results were available. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2786764|NCT00617305|Secondary|Change From Baseline in Cardiac Output (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. An increase in measurement value (L/min) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||L/min||Standard Deviation|Mean
2786817|NCT00617097|Secondary|Visual Analogue Scale Regarding Satisfaction Level|100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)|end of study (prior to clinic discharge)||||mm||Standard Deviation|Mean
2786752|NCT00617344|Secondary|Number of Participants With Solicited Injection Site Reactions After Any Vaccination|Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >=5 cm. Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >=5 cm.|7 days after any injection 1, 2 or 3|Analysis was performed on Safety Analysis Set which included all participants included in the trial who had received at least 1 dose of study vaccine and had any available safety data. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2786753|NCT00617344|Secondary|Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain|Geometric mean titers against each dengue virus serotype (1, 2, 3 and 4) strain was measured by PRNT.|Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)|Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2786754|NCT00617344|Secondary|Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes|Percentage of participants with antibody titers >= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. In this outcome measure, participants with antibody titers >= 10 1/dil against any 1 of the 4 serotypes or any 2 of the 4 serotypes or any 3 of the 4 serotypes or with all 4 serotypes were reported.|Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)|Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.|||percentage of participants|||Number
2786755|NCT00617344|Secondary|Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain|Percentage of participants with antibody titers >= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT.|Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)|Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.|||percentage of participants|||Number
2786756|NCT00617344|Primary|Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation|Percentage of participants with antibody titers >= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)|Analysis was performed on Full Analysis Set (FAS). Here, ‘number analyzed’ = participants with available data for each specified category.|||percentage of participants|||Number
2786757|NCT00617305|Secondary|Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|Overall survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of death after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Overall Survival|||Probability of death occurring (%)||95% Confidence Interval|Number
2786758|NCT00617305|Secondary|Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|The time to clinical worsening was defined as the time from enrollment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, or initiation of chronic parenteral prostanoid therapy. Results are presented as the Kaplan-Meier estimate (% probability) of having clinical worsening after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Time to Clinical Worsening|||Probability of clinical worsening (%)||95% Confidence Interval|Number
2786759|NCT00617305|Secondary|Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean percent change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. A decrease in log-transformed measurement value (pg/mL) indicates improvement for this patient population.|Baseline to Week 48|One patient (Any Placebo) was not evaluated for NT-proBNP. One patient (Placebo Only) had no baseline measurement, so no statistical analyses for change from baseline are given for the placebo only group (patient was only subject in this group).|||pg/mL (log-transformed)||Standard Deviation|Mean
2786760|NCT00617305|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.|The primary analysis of this secondary outcome measure is change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. WHO categories are 1 to 4 with the worst category being 4. Improvement is represented by a change in category to a lower number (for example, change from category 3 to 2), and deterioration is represented by a change in category to a higher number (for example, change from category 2 to 4). No change is represented by no change in category (for example, category 2 which remains 2).|Baseline to Week 48|All enrolled Population|||participants|||Number
2786761|NCT00617305|Secondary|Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 12, 36, and 48 were also evaluated. Lower scores and decreases from baseline represent improved functioning and QOL. The CAMPHOR survey was not assessed at Week 4. The total CAMPHOR score scale ranges from 0 (good) to 25 (poor). A reduction in score over time represents improvement in this patient population.|Baseline to Week 48|All enrolled Population|||units on a scale||Standard Deviation|Mean
2786762|NCT00617305|Secondary|Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. The dyspnea index measures the degree of breathlessness after completion of the 6MWT using a scale of 0 to 10, with 0 indicating no breathlessness and 10 indicating maximum breathlessness.|Baseline to Week 48|All enrolled Population|||units on a scale||Standard Deviation|Mean
2786920|NCT00616239|Primary|Number of Participants Showing Improvement of Melasma Based on Mexameter Readings|The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.|14 weeks||||participants|||Number
2786767|NCT00617305|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)|The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm^5) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated|||dynes sec/cm^5||Standard Deviation|Mean
2786768|NCT00617279|Secondary|Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure|The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.|One month|The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.|||scores on a scale||Standard Deviation|Mean
2786769|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months||||Participants|||Number
2786770|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months||||Participants|||Number
2786771|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through One Month Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month||||Participants|||Number
2786772|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 12 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months||||Participants|||Number
2786773|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 6 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months||||Participants|||Number
2786774|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through One Month Post-procedure|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month||||Participants|||Number
2786775|NCT00617279|Secondary|Number of Patients Surviving at 12 Months||12 months||||Participants|||Number
2786776|NCT00617279|Secondary|Number of Patients Surviving at 6 Months||6 months||||Participants|||Number
2786777|NCT00617279|Secondary|Number of Patients Surviving at One Month||One month||||Participants|||Number
2786778|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 12 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months||||Participants|||Number
2786779|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 6 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|6 months||||Participants|||Number
2786780|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|12 months||||Participants|||Number
2786781|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|6 months||||Participants|||Number
2786782|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|One month||||Participants|||Number
2786783|NCT00617279|Secondary|Number of Patients With Secondary Patency at 12 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.|||Participants|||Number
2786784|NCT00617279|Secondary|Number of Patients With Secondary Patency at 6 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.|||Participants|||Number
2786785|NCT00617279|Secondary|Number of Patients With Secondary Patency at One Month|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|||Participants|||Number
2790101|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2786786|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 12 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.|||Participants|||Number
2786787|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 6 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.|||Participants|||Number
2786788|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at One Month Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|One month||||Participants|||Number
2786789|NCT00617279|Secondary|Number of Patients With Primary Patency at 6 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.|||Participants|||Number
2786790|NCT00617279|Primary|Major Adverse Event Occurrences Through One Month Post-procedure|The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.|one month post-index procedure||||Events|||Number
2786791|NCT00617279|Secondary|Number of Patients With Primary Patency at One Month Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|||Participants|||Number
2786792|NCT00617279|Primary|Number of Patients With Primary Patency at 12 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.|||Participants|||Number
2786793|NCT00617240|Secondary|Incidence of Metabolic Syndrome|Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.|24 weeks||||participants|||Number
2786794|NCT00617240|Secondary|Change From Baseline to Week 24 in Triglycerides|In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.|24 weeks|Only participants with complete data on triglyceride levels at both baseline and 24 weeks were utilized.|||mg/dl||Standard Error|Mean
2786795|NCT00617240|Secondary|Change From Baseline to Week 24 in Cholesterol Level|According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.|24 weeks|Only participants with complete data on cholesterol levels at both baseline and 24 weeks were utilized.|||mg/dl||Standard Error|Mean
2786796|NCT00617240|Secondary|Change From Baseline to Week 24 in Insulin Level|Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.|24 weeks|Only participants with complete data on insulin levels at both baseline and 24 weeks were utilized.|||microIU/ml||Standard Error|Mean
2786797|NCT00617240|Primary|Change From Baseline to Week 24 in Fat Mass|Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.|24 weeks|Only participants with complete data on fat mass at both baseline and 24 weeks were utilized.|||kg||Standard Error|Mean
2786798|NCT00617240|Primary|Change From Baseline to Week 24 in Weight|Change in weight is calculated as 24 weeks weight minus the baseline weight.|24 weeks||||kg||Standard Error|Mean
2786799|NCT00617240|Primary|Change From Baseline to Week 24 in Body Mass Index (BMI)|Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.|0-24 weeks|All participants who took at least one dose of study treatment and had at least one post baseline assessment.|||kg/m^2||Standard Error|Mean
2786800|NCT00617201|Secondary|Retention|Trial retention- those who complete the 12 week dosing period|12-weeks|those completing the 12-week study after randomization|||days||Standard Error|Mean
2821314|NCT00373685|Secondary|Hematocrit (Hct) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed|||Percent||Standard Deviation|Mean
2786803|NCT00617188|Primary|Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Day 90||||Participants|||Number
2786804|NCT00617188|Secondary|Serum Skeletal-Specific Alkaline Phosphatase Concentration|Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.|Baseline, 1 Month, 3 Months, 6 Months||||Units/Liter||Full Range|Median
2786805|NCT00617188|Secondary|Mean Scores - Quality of Life Assessment|Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.|Baseline, 3 Months Post Treatment, 6 Months Post Treatment||||Scores on a Scale||Full Range|Mean
2786806|NCT00617188|Secondary|Median Number of Days to Treatment Termination|Time is determined from first dose to termination due to all causes.|Up to 373 Days||||Days||Full Range|Median
2786807|NCT00617188|Secondary|Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)|Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.|Day 90||||Participants|||Number
2786808|NCT00617175|Secondary|Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.||end of study|||||||
2786809|NCT00617175|Primary|For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.|"for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.~The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100."|From enrollment to study completion or exit whichever occured first|For the primary endpoint analysis, only patients with at least a device data record were considered.|||rate of therapies per 100 patient-years||95% Confidence Interval|Number
2786810|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography|Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment as measured by fundus photogrpahy.|||score on a scale||Standard Error|Mean
2786811|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT|Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment by OCT.|||score on a scale||Standard Error|Mean
2786812|NCT00617123|Secondary|Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT|Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline center point thickness assessment by OCT.|||participants|||Number
2786813|NCT00617123|Secondary|Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline|Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline visual acuity score.|||participants|||Number
2786814|NCT00617123|Primary|Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)|Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).|Up to 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment.|||participants|||Number
2786815|NCT00617097|Secondary|Complications||end of study||||participants|||Number
2786816|NCT00617097|Secondary|Reported Symptoms|fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)|end of study (upon discharge from facility after procedure)||||participants|||Number
2827876|NCT00319982|Secondary|Adherence to Study Medication|Adherence to study medication was assessed by pill count|Duration of the trial||||percentage of pills taken||Standard Deviation|Median
2786818|NCT00617097|Primary|Level of Pain During Specific Time Intervals Throughout D&C Procedure.|"100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain)~Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure."|Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure||||mm||Standard Deviation|Mean
2786819|NCT00617084|Secondary|In-Stent Percent Diameter Stenosis|In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.|13 Months||||Percentage diameter stenosis||Standard Deviation|Mean
2786820|NCT00617084|Primary|Target Lesion Failure|Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.|12 months|Analysis per intention to treat|||percentage of participants|||Number
2786821|NCT00617058|Secondary|Percent Change in LDL||24 weeks||||percent change|||Number
2786822|NCT00617058|Secondary|Percent Change in HDL||24 weeks||||percent change|||Number
2786823|NCT00617058|Secondary|Percent Change in Glucose Levels||24 weeks||||percent change|||Number
2786824|NCT00617058|Primary|Percent Change in Weight||24 weeks||||percent change|||Number
2786825|NCT00617058|Secondary|Incidence of Metabolic Syndrome||24 weeks||||participants|||Number
2786826|NCT00617058|Secondary|Percent Change in Triglycerides||24 weeks||||percent change|||Number
2786827|NCT00617058|Secondary|Percent Change in Total Cholesterol||24 weeks||||percent change|||Number
2786828|NCT00617058|Secondary|Percent Change in Insulin Levels||24 weeks||||percent change|||Number
2786829|NCT00617058|Primary|Percent Change in Fat Mass||24 weeks||||percent change|||Number
2786830|NCT00617058|Primary|Absolute Change in Weight||24 weeks||||lbs.|||Number
2786831|NCT00617058|Primary|Percent Change in BMI||24 weeks|This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures.|||percent change|||Number
2786832|NCT00616967|Post-Hoc|Baseline and Change in Continuous Variables (e.g., Candidate Gene Methylation, Expression Profiles, Tissue, and Peripheral Blood Mononuclear Cell Histone Acetylation)||Time of breast cancer surgery|||||||
2786833|NCT00616967|Secondary|Overall Survival||Up to death of last participant (duration unknown)|||||||
2786834|NCT00616967|Secondary|Number of Participants With Recurrence of Breast Cancer||Up to death of last participant (duration unknown)|||||||
2786835|NCT00616967|Secondary|Number of Participants Who Develop New Cancer||Up to death of last participant (duration unknown)|||||||
2786836|NCT00616967|Secondary|Number of Participants Who Experience Death During Treatment||Up to 12 weeks||||Participants|||Count of Participants
2786837|NCT00616967|Secondary|Cumulative Methylation Index (CMI) at Day 15||Day 15|Methylation data was only evaluable in 11/17 and 39/45 participants.|||CMI||Full Range|Median
2786838|NCT00616967|Secondary|Change in Cumulative Methylation Index (CMI)|Change of CMI from baseline to Day 15 (D15), defined as log(D15 CMI + 1/baseline CMI + 1). The CMI was calculated as a sum of all gene-specific methylation indexes within a panel of 10 genes which included: HIST1H3C, AKR1B1, GPX7, HOXB4, TMEFF2, RASGRF2, COL6A2, ARHGEF7, TM6SF1, and RASSF1A.|Change from baseline to Day 15|Methylation data was only evaluable in participants with both baseline and D15 tissue (48/62) and serum (58/62) specimens.|||CMI||Full Range|Median
2786839|NCT00616967|Secondary|Absolute Change From Baseline in Ki-67||Change from baseline to Cycle 1-Day 15|Only 8/17 and 36/45 specimens were evaluable for Ki-67 at both baseline and Day 15. Nonevaluable samples had no tumor cells present or Ki-67 unavailable at either or both time points.|||percent change in Ki-67||Standard Deviation|Mean
2786840|NCT00616967|Secondary|Change in Standard Uptake Value (SULmax) From Baseline to Day 15 on FDG-PET|Change in standard uptake value (SULmax) as measured by percentage reduction of SULmax. The standard uptake value used for the PET analysis was SULmax, which is the standard uptake value normalized for lean body mass.|Baseline and day 15|"16/17 Responders (from Outcome 1) had PET data evaluable for analysis; 43/45 non-responders (from Outcome 1) had PET data evaluable for analysis. Reasons for PET data not evaluable included technically invalid 18F-FDG PET data (2 participants) and no available Day 15 18F-FDG PET data (1 participant)."|||percentage reduction in SULmax||Full Range|Median
2786841|NCT00616967|Secondary|Number of Participants With Clinical Complete Response (cCR)|cCR in the breast on physical is defined as the absence of any palpable abnormality on breast exam Iie: no skin or breast thickening, mass or associated skin or nipple changes)|12 weeks||||Participants|||Count of Participants
2786842|NCT00616967|Secondary|Safety as Measured by Number of Participants Who Experience Adverse Events|Number of participants who experience adverse events as defined by NCI CTCAE version 3.0|up to 30 days post-treatment||||Participants|||Count of Participants
2786843|NCT00616967|Primary|Pathological Complete Response (pCR) Rate|The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.|Time of breast cancer surgery|"The information for the primary populations for analysis are included (Placebo and Vorinostat arms). Data for this outcome measure was not collected from the initial run-in phase of 6 participants."|||Participants|||Count of Participants
2786844|NCT00616941|Secondary|Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline|Radiographic imaging (computed tomography of the abdomen and pelvis) was obtained at Screening and every 2 months during the study, and at unscheduled time points if any clinical symptoms/examination findings warranted further evaluation or if serum CA-125 rose to > 70 U/mL (confirmed by repeat value). Subjects may have had more than 1 location of disease.|Screening and every 2 months up to Week 16|The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy assessment performed.|||Participants|||Count of Participants
2786845|NCT00616941|Secondary|Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline|Serum CA-125 was measured at Screening, Week 7, and Week 16. Stable CA-125 at baseline was < 35 U/mL (defined as CA-125 that had not doubled from the post chemotherapy nadir).|Screening, Week 7, and Week 16|The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy measurement performed.|||U/mL||Standard Deviation|Mean
2786846|NCT00616941|Secondary|Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16|NY-ESO-1-specific DTH was measured by skin tests at Screening and again at Week 16. NY-ESO-1 OLP4 (40 µg in 0.1 mL D5W) was injected intradermally, with DTH reactions read 48 hours after injection.|Screening and Week 16|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2786847|NCT00616941|Secondary|Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline|Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. NY-ESO-1-specific CD8+ and CD4+ T-cell reactivity was measured by tetramer analysis (in human leukocyte antigen [HLA] 0201* patients). Interferon gamma (IFN-γ) release by T cells was measured by the enzyme-linked immunospot (ELISPOT) assay. A subject was considered to have experienced a T-cell response if IFN-γ spots were detectable (>50 spots) by ELISPOT of 50,000 CD8+ and CD4+ T cells following pre-sensitization with a pool of 20-mer OLP covering all of NY-ESO-1 and tested against Epstein-Barr virus-transformed B cells pulsed with 3 subpools of these peptides.|Screening and Weeks 4, 7, 10, 13, and 16|The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.|||Participants|||Count of Participants
2786848|NCT00616941|Secondary|Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline|Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. Specific antibodies against NY-ESO-1 were measured by enzyme-linked immunosorbent assay (ELISA).|Screening and Weeks 4, 7, 10, 13, and 16|The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.|||Participants|||Count of Participants
2786849|NCT00616941|Primary|Overview of Treatment-emergent Adverse Events (TEAEs)|Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment.|Continuously for up to 16 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2786850|NCT00616928|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays|Titers were expressed as Geometric Mean Titers (GMTs).|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.|||Titers||95% Confidence Interval|Geometric Mean
2786851|NCT00616928|Secondary|Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.|Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.|||Subjects|||Number
2786852|NCT00616928|Secondary|Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2786853|NCT00616928|Secondary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)||At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6|||Subjects|||Number
2786854|NCT00616928|Secondary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6|||Subjects|||Number
2786855|NCT00616928|Secondary|Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10||At Month 6 (Day 182) post Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6|||Subjects|||Number
2786856|NCT00616928|Secondary|Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10||At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.|||Subjects|||Number
2786857|NCT00616928|Primary|Number of Subjects With Medically Attended Events (MAEs)||From Day 0 through Day 182 and through Day 364.||||Subjects|||Number
2786858|NCT00616928|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 through Day 182 and through Day 379.||||Subjects|||Number
2786859|NCT00616928|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)||||Subjects|||Number
2786860|NCT00616928|Primary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.|||Subjects|||Number
2786861|NCT00616928|Primary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.|||Subjects|||Number
2786862|NCT00616928|Primary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.|||Subjects|||Number
2786863|NCT00616928|Primary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.|||Subjects|||Number
2786864|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)|Plasma BNP is a product from the heart that becomes elevated with an enlarged heart and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||ng/L||Standard Deviation|Mean
2786865|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks|Plasma high sensitivity CRP is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||mg/L||Standard Deviation|Mean
2786866|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks|Plasma IL-6 is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||cm/sec||Standard Deviation|Mean
2786867|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks|Plasma troponin-t is a marker of heart damage and and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||mcg/L||Standard Deviation|Mean
2786868|NCT00616902|Secondary|Change From Baseline in Biological Marker Triiodothyronine (T3).|Plasma T3 is a circulating hormone that may have an effect on diastolic heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.|||nmol/L||Standard Deviation|Mean
2786869|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks|E-wave deceleration time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||sec||Standard Deviation|Mean
2786870|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.|The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.|Baseline, Week 24, and Week 48/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||cm/sec||Standard Deviation|Mean
2786871|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.|Isovolumetric relaxation time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||sec||Standard Deviation|Mean
2786872|NCT00616902|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|"Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.~The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48."|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug and the Evaluable population (a subset of ITT population and consists of those participants who have completed Week 24 visit). None of the participants completed 24 or 48 weeks.|||g/m2.7||Standard Deviation|Mean
2786873|NCT00616902|Secondary|Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.|Mitral Annular relaxation velocity is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.|||cm/sec||Standard Deviation|Mean
2786874|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 6 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 6 or more segments matched the segments at baseline and at 2 years.|||mm/year||Standard Error|Mean
2786875|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.|||mm/year||Standard Error|Mean
2786876|NCT00616772|Secondary|Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.|||mm/year||Standard Error|Mean
2786877|NCT00616772|Secondary|Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter.|||mm/year||Standard Error|Mean
2786878|NCT00616772|Primary|Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized participants who had both a baseline value and at least 1 postbaseline value for that parameter.|||mm/year||Standard Error|Mean
2786879|NCT00616759|Primary|Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index|WMS-III Auditory Delayed Index is a measure of memory functioning. The results given are the post-ECT testing results. A smaller number indicates less memory disturbance on this scale. The range of scores is between 0-140 with higher scores indicating better memory function.|Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT.|The measurements listed are post-ECT testing for both groups|||units on a scale||Standard Deviation|Mean
2786880|NCT00616759|Secondary|California Verbal Learning Test (CVLT)|CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.|Within one week pre-ECT and within 48 hours after the 6th ECT|||||||
2786881|NCT00616655|Secondary|Change From Baseline Epworth Sleepiness Scale (ESS)|ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2786882|NCT00616655|Secondary|Change From Baseline Sheehan Disability Scale (SDS)|The SDS was completed by the subject and captured the subject's level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2786883|NCT00616655|Secondary|Change From Baseline Insomnia Severity Index (ISI) Total Score|The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.|Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2786884|NCT00616655|Secondary|Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form|The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2787297|NCT00612573|Primary|Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population|Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.|Baseline to Week 12|ITT Population|||Lesions||Standard Deviation|Mean
2786885|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) Remission|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less.~The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||participants|||Number
2786886|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score.~The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||participants|||Number
2786887|NCT00616655|Secondary|Clinical Global Impression- Improvement (CGI-I)|"CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, Compared to his/her condition at Visit 2, how much has he/she changed? The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement."|Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2786888|NCT00616655|Secondary|Change From Baseline in Clinician Global Impression of Severity (CGI-S)|"The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, Considering your total clinical experience with this particular population, how anxious is the subject at this time? The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity."|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2786889|NCT00616655|Secondary|Change in Individual Item Scores on HAM-A|The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.|Baseline, Weeks 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||units on a scale||Standard Deviation|Mean
2786890|NCT00616655|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)|The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.|||unit on a scale||Standard Deviation|Mean
2786891|NCT00616655|Primary|Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater|THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline to Week 8|ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period.|||Units on a scale||Standard Deviation|Mean
2786892|NCT00616642|Primary|Efficacy of Rosiglitazone Maleate on Cushing Disease|Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.|12 months|No data was analyzed for this outcome measure as there was insufficient data to perform analysis.||||||
2786893|NCT00616629|Secondary|Number of Patients Who Had at Least One AE|Number of patients|During active treatment period||||Participants|||Number
2786894|NCT00616629|Secondary|AUC Total of AZD1305 (Umol*h/L)|A total of 13 scheduled PK samples for each patient during and after infusion|Based on PK samples during and after infusion||||umol*h/L||Full Range|Mean
2786895|NCT00616629|Secondary|Cmax Observed for AZD1305|A total of 13 scheduled PK samples for each patient during and after infusion|During and after infusion||||umol/L||Full Range|Mean
2786896|NCT00616629|Secondary|QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona||||ms||Full Range|Mean
2786897|NCT00616629|Secondary|VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product||||ms||Full Range|Mean
2786898|NCT00616629|Secondary|RAERP (Right Atrial Effective Refractory Period)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product||||ms||Full Range|Mean
2786899|NCT00616629|Primary|LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product||||ms||Full Range|Mean
2786900|NCT00616603|Primary|Duration of Sciatic Nerve Block|Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores|from the time the block was placed up to 24 hours|PI left the institution and no analysis completed due to questionable data integrity||||||
2786901|NCT00616577|Primary|Usage of Pain Medications||Over 24 hours|PI left institution and records cannot be located.||||||
2786902|NCT00616434|Secondary|Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8|The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline SCCAI ≥ 3 was available.|||percentage of participants|||Number
2786903|NCT00616434|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE's were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.|Up to 16 weeks|Safety Population; participants who were randomized and received at least one dose of study treatment.|||participants|||Number
2786904|NCT00616434|Primary|Percentage of Participants With a Clinical Response|Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline measure was available.|||percentage of participants|||Number
2786905|NCT00616421|Secondary|Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.|day 1 to study termination (day 240)|The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported.|||Percentage of Subjects|||Number
2786906|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.|||Percenatage of subjects|||Number
2786907|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.|||Percentages of subjects|||Number
2787013|NCT00615017|Secondary|Number of Patients Below Tumour Necrosis Factor (TNF)-Alpha Limit of Quantification (LOQ) at 24 Hours (n< LOQ)|Number of patients below tumour necrosis factor (TNF)-alpha limit of quantification (LOQ) at 24 hours (n< LOQ) measured by ELISA (LOQ = 1.3 pg/mL). Safety analysis set (ie all patients who started study drug infusion).|24 hours|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Participants|||Number
2786908|NCT00616421|Secondary|GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.~ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2786909|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2786910|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2786911|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2786912|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2786913|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2786914|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
2786915|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2786916|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percenatage of subjects||95% Confidence Interval|Number
2786917|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2786918|NCT00616343|Primary|Tremor Severity|PI has left the institution and we are unable to accurately assess the data from the remaining records.|4 weeks|||||||
2786919|NCT00616239|Secondary|Improvement of Melasma Based on MASI Scores, Melasma Severity Assessment, and Physician and Patient Global Improvement Compared With the Opposite Side.||14 weeks|||||||
2786921|NCT00616200|Secondary|Sickness Impact Profile|Units of measurement on the Sickness Impact Profile were ordinal rated scored. Information on scoring use and interpretation of the Sickness Impact Profile, readers are encouraged to read Bergner et. al. 1981 - Bergner, M., Bobbit, R.A., Carter, W.B. et all (1981) the Sickness Impact Profile: Development and final revision of a health status measure. Medical Care, 19:787-805 The SIP measures sickness-related dysfunction based on behavior in order to provide a measure of health status that will aid in assessing the outcome of health care services.|At the end of four week VLCD|The scoring range is from no impairment with a score of 0, to significant impairment, with 5. Changes in score of 3.5 are considered clinically significant.|||Scores on a scale||Standard Deviation|Mean
2786922|NCT00616200|Secondary|Impact of Very Low Carbohydrate Diet on Stool Frequency|Stool Frequency was measured as number of stools per day|6 Weeks|Analysis was per protocol analysis|||Stools Per day||Standard Deviation|Mean
2786923|NCT00616200|Primary|"Number of Subjects Reporting Adequate Relief From IBS Symptoms for the Previous Week. Adequate Relief Was a True/False Item."|"Adequate relief was measured as the primary endpoint via a single item Adequate Relief Question asking Over the past week have you had adequate relief of your symptom experience. Higher scores represent greater levels of adequate relief over the week prior to the assessment. Participants completed this 1-item questionnaire at the end of each of weeks of the study, assessing whether they had adequate relief of their IBS symptoms for the week.~A responder was defined as reporting adequate relief in at least 2 of the 4 weeks on the VLCD."|At the end of each of 6 study weeks||||Participants|||Number
2786924|NCT00616122|Secondary|Duration of Response|"Duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable: Does not qualify for complete response, partial response or progression.~Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|until disease progression up to 13 months post treatment|A partial response was only reported for one patient, while a complete response was not recorded for any patients.|||weeks|||Number
2786925|NCT00616122|Secondary|Overall Response Rate|"Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable: Does not qualify for complete response, partial response or progression."|until disease progression, up to 13 months post treatment||||participants|||Number
2786926|NCT00616122|Primary|Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II)|Progression defined as: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), or appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer).|up to 12 weeks after treatment start date|Patients who received either 25mg or 37.5mg of sunitinib and were not removed from study due to voluntary withdrawal or PD prior to receiving combination sunitinib and metronomic CM chemotherapy.|||participants|||Number
2786927|NCT00616122|Primary|Maximum Tolerated Dose of Sunitinib (Phase I)|"Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 degrees Celsius or 3 readings of oral temperature > 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment.~5) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity."|8 weeks||||mg|||Number
2786928|NCT00616109|Secondary|Number of Patients That Discontinue Drug Due to Toxicity|"Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0.~In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to < grade 1 and then the drug should be restarted at a one dose-level reduction.~Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study.~No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study."|20 weeks|All patients who received sunitinib maintenance therapy were evaluable for toxicity and tolerability analysis.|||participants|||Number
2786929|NCT00616109|Secondary|Percent of Patients With an Objective Response|Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).|12 weeks (2 cycles)|Patients who received at least 2 cycles of study therapy (maintenance sunitinib)|||percentage of participants|||Number
2787014|NCT00615017|Secondary|Tmax of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Hours||Full Range|Median
2786930|NCT00616109|Secondary|Median Overall Survival|Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.|up to 4 months post treatment|15 participants in Sunitinib maintenance therapy (main study) were enrolled and were evaluable for this outcome measure. Although 16 patients were enrolled, one patient opted to discontinue therapy, refused further follow-up, and was therefore censored from survival analysis.|||months||95% Confidence Interval|Median
2786931|NCT00616109|Primary|Progression Free Survival Rate|The proportion of patients who are progression-free at 4 months after starting sunitinib.|4 Months Post Treatment|All 16 patients enrolled received a median of 4 weeks sunitinib maintenance therapy. 1 patient who discontinued requested no follow up and was censored from survival analysis. All survival endpoints were analyzed using the Kaplan-Meier method (Kaplan El, Meier P, Non-parametric Estimation from Incomplete Observations, J Am Stat Association, 1958)|||percentage of patients with PFS||95% Confidence Interval|Number
2786932|NCT00616018|Secondary|Alanine Aminotransferase (ALT)|ALT was measured at Day 0, 4, 7, 9, 11, and 14.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.|||IU/L||Standard Deviation|Mean
2786933|NCT00616018|Primary|Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts|Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.|||nmol/mL||Standard Deviation|Mean
2786934|NCT00615992|Secondary|Global Assessment of Tolerability by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
2786935|NCT00615992|Secondary|Global Assessment of Efficacy by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
2786936|NCT00615992|Secondary|Global Assessment of Tolerability by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
2786937|NCT00615992|Secondary|Global Assessment of Efficacy by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||Participants|||Number
2786938|NCT00615992|Secondary|Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||points on a scale||Standard Deviation|Mean
2786939|NCT00615992|Primary|Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.|||points on a scale||Standard Deviation|Mean
2786940|NCT00615927|Secondary|Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas|The number of patients experiencing any serious adverse event or other (non-serious) adverse event during the study participation.|156 weeks||||participants|||Number
2786941|NCT00615927|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|156 weeks||||participants|||Number
2786942|NCT00615927|Secondary|Median Overall Survival (OS)|Time in weeks from the start of cycle 1 to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks|Median overall survival was not estimable for either arm as not enough events of death occurred|||weeks||95% Confidence Interval|Median
2786943|NCT00615927|Secondary|Median Progression-free Survival|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks||||weeks||95% Confidence Interval|Median
2786944|NCT00615927|Primary|12-month Progression Free Survival (PFS)|Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|12 months||||percentage of participants||95% Confidence Interval|Number
2786945|NCT00615914|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.|during 18 months|Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.|||percentage of participants|||Number
2786946|NCT00615914|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn & Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).|||Unit on a scale||Standard Deviation|Mean
2786947|NCT00615914|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).|||Unit on a scale||Standard Deviation|Mean
2786948|NCT00615914|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|18 months|A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.|||Participants|||Number
2786949|NCT00615901|Primary|The Number of Patients Who Completed 8 Cycles.|the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.|2 years||||participants|||Number
2786950|NCT00615836|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities."|From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).|Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure; therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.|||participants|||Number
2786951|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786952|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786953|NCT00615836|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score|"The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2787029|NCT00615017|Primary|Change From Baseline in Prothrombin Time Values|Change in prothrombin time values from baseline (pre-infusion) to Day 7 [calculated as Day 7 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 7|Participants analyzed relates to the number of evaluable patients at the specified time point.|||sec||Full Range|Mean
2786954|NCT00615836|Secondary|Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786955|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786956|NCT00615836|Secondary|Change From Baseline in NQoL Bother/Concern Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786957|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786958|NCT00615836|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score|"The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question Night time urination: How much does this bother you? on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||units on a scale||Standard Deviation|Mean
2786959|NCT00615836|Secondary|Change From Baseline in Total Sleep Time|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||minutes||Standard Deviation|Mean
2786975|NCT00615459|Secondary|Peak FEV1 During 4 Hours Post Morning Dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|Day 1 (from 0 to 4 hours post morning dose)|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug.|||Liters||Standard Error|Least Squares Mean
2787073|NCT00614744|Secondary|Number of Infants With a DNR Order||Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
2786960|NCT00615836|Primary|Change From Baseline in Initial Period of Undisturbed Sleep|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||minutes||Standard Deviation|Mean
2786961|NCT00615836|Primary|Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids|"Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||percentage of participants|||Number
2786962|NCT00615836|Primary|Change From Baseline in Mean Number of Nocturnal Voids|"Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.|||nocturnal voids||Standard Deviation|Mean
2786963|NCT00615719|Primary|The Presence of Acute Coronary Syndromes(ACS).|The presence of ACS was determined by either cardiac angiography, nuclear perfusion imaging or a clinical course deemed consistent with ACS by final chart review. The number of participants with ACS was determined.|During the presenting illness, usually within two to three days.|Only 30 evaluable patients in study powered for 80 patients.|||participants|||Number
2786964|NCT00615589|Secondary|Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression|Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.|3 years||||percentage of deaths||95% Confidence Interval|Number
2786965|NCT00615589|Secondary|Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)|"Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.~Acute GVHD Grading:~Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus"|100 days, 2 years||||percentage of participants||95% Confidence Interval|Number
2786966|NCT00615589|Secondary|Percentage of Patients With Treatment Related Mortality (TRM)||100 days, one-year||||percentage of patients||95% Confidence Interval|Number
2786967|NCT00615589|Secondary|The Percentage of Patients Free From Progression at 1 Year|"One of the secondary outcomes that will be measured is progression free survival at 1 Year.~Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia."|1 Year||||percentage of patients||95% Confidence Interval|Number
2786968|NCT00615589|Primary|The Percentage of Patients Alive 1 Year Post Transplant|The primary objective is overall survival, one year from the time of transplant.|1 Year||||percentage of patients||95% Confidence Interval|Number
2786969|NCT00615550|Secondary|Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams|Assessment of birth weight < 1500 grams or < 2500 grams|date of delivery|Available birth weight.|||participants|||Number
2786970|NCT00615550|Secondary|Number of Neonates Who Died.||Delivery to 28 days|All infants with a known delivery date and status.|||participants|||Number
2786971|NCT00615550|Secondary|Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.|Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.|Gestational Age at Delivery|Intent to Treat|||participants|||Number
2786972|NCT00615550|Secondary|Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)|"Each infant is scored based on the 7 morbidity and mortality events above:~0= no morbidity event~1 morbidity event~2 morbidity events~3 or more morbidity events~mortality"|Delivery Hospitalization (1-212 days)||||participants|||Number
2786973|NCT00615550|Primary|Number of Participants With Birth <=32 6/7 Weeks Gestation.||9 to 13 weeks|Intent to Treat|||participants|||Number
2786974|NCT00615472|Primary|Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes|A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.|Four months||||participants|||Number
2787001|NCT00615108|Secondary|Percentage of Patients Achieving BP Response|Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.|||percentage of participants|||Number
2786976|NCT00615459|Primary|24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug. Patients were analyzed according to treatment they received.|||Liters||Standard Error|Least Squares Mean
2786977|NCT00615433|Secondary|CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.|The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scale||95% Confidence Interval|Least Squares Mean
2786978|NCT00615433|Primary|Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.|The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.|Baseline and 6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2786979|NCT00615420|Primary|Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments|Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.|Over 7 weeks of expected duration of mucositis|Patients who had a minimum of 2 mucositis assessments were included in this analysis|||Participants|||Count of Participants
2786980|NCT00615420|Primary|Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment|Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.|Over 7 weeks of expected duration of mucositis|Patients who had at least one mucositis assessment were included in this analysis|||Participants|||Count of Participants
2786981|NCT00615290|Secondary|Patient Self Perception of the New Treatment|"Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied"|Day 0, month 3 and month 6|All enrolled patients|||millimeter||Standard Deviation|Mean
2786982|NCT00615290|Secondary|CD4 Count at 3 Months||3 months after inclusion|All enrolled patients with data at 3 months|||cells/cubic millimeter||Inter-Quartile Range|Median
2786983|NCT00615290|Secondary|Viral Load Response at 3 Months|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|3 months after inclusion|All enrolled patients with data at 3 months|||copies/mL||Inter-Quartile Range|Median
2786984|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL|Number of patients with a viral load < 50 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months|||participants|||Number
2786985|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL|Number of patients with a viral load < 400 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months|||participants|||Number
2786986|NCT00615290|Secondary|CD4 Count at 1 Month||1 month after inclusion|All enrolled patients with data at 1 month|||cells/cubic millimeter||Inter-Quartile Range|Median
2786987|NCT00615290|Secondary|Viral Load Response at 1 Month|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|1 month after inclusion|All enrolled patients with data at 1 month|||copies/mL||Inter-Quartile Range|Median
2786988|NCT00615290|Secondary|Evaluation of Early Virological Response|Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10|1 month after inclusion|All enrolled patients with data at 1 month|||participants|||Number
2786989|NCT00615290|Primary|Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3|The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3|6 months after inclusion|All enrolled patients with data at 6 months|||participants|||Number
2786990|NCT00615264|Secondary|Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months|Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 Months|Modified Intent to Treat (MITT) Population|||nmol*minute/L||Standard Error|Mean
2787002|NCT00615108|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control|BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Subjects include those who took 20mg, 40mg, 80mg and unknown dosage|||Percentage of Participants|||Number
2786991|NCT00615264|Primary|Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Modified Intent to Treat (MITT) Population - all randomized patients who received at least one dose of study medication and who entered the study according to the definition of the target population, as defined by the inclusion and exclusion criteria in the study protocol|||nmol*minute/L||Standard Error|Mean
2786992|NCT00615199|Secondary|Time to First Response 100|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.|||days||95% Confidence Interval|Median
2786993|NCT00615199|Secondary|Time to First Response 70|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.|||days||95% Confidence Interval|Median
2786994|NCT00615199|Secondary|Time to First Clinical Remission|Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.|||days||95% Confidence Interval|Median
2786995|NCT00615199|Secondary|Number of Participants With Clinical Response 100 at Week 4|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.|||participants|||Number
2786996|NCT00615199|Secondary|Number of Participants Achieving Clinical Remission at Week 4|Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.|||participants|||Number
2786997|NCT00615199|Secondary|Number of Participants With Clinical Response 70 at Week 1 and 2|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1, 2|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least (>=)1 week of dosing and had >=1 valid CDAI score during active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside visit window. ‘n’=participants evaluable at given time point for each group.|||participants|||Number
2786998|NCT00615199|Primary|Number of Participants With Clinical Response 70 at Week 4|Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|Full Analysis Set (FAS): all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.|||participants|||Number
2786999|NCT00615108|Secondary|Overall Assessment by Attending Physicians|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:~4: Outstanding 3: Very satisfactory 2: Satisfactory~1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage|||Percentage of Participants|||Number
2787000|NCT00615108|Secondary|Overall Assessment by Patients|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:~4: Outstanding 3: Very satisfactory 2: Satisfactory~1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.|||Percentage of Participants|||Number
2787005|NCT00615056|Secondary|Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||Units on a Scale||95% Confidence Interval|Mean
2787006|NCT00615056|Secondary|Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||Units on a Scale||95% Confidence Interval|Mean
2787007|NCT00615056|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
2787008|NCT00615056|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2787009|NCT00615056|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or up to 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2787010|NCT00615056|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2787011|NCT00615030|Secondary|Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons|Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|After 14 days of dosing|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means.|||Liters||Standard Error|Least Squares Mean
2787012|NCT00615030|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo|"Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate.~The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period."|After 14 days of treatment|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means. This analysis included all patients who received indacaterol in the evening or placebo in their assigned treatment sequence.|||Liters||Standard Error|Least Squares Mean
2787015|NCT00615017|Secondary|Cinf of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|Cinf of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg/mL||Full Range|Geometric Mean
2787016|NCT00615017|Secondary|AUC(0-12) of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg.h/mL||Full Range|Geometric Mean
2787017|NCT00615017|Secondary|Time to Reach Cinf (Tmax) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Hours||Full Range|Median
2787018|NCT00615017|Secondary|Maximum (End of Infusion) Serum Concentration (Cinf) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3,4 and 5)|Cinf of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg/mL||Full Range|Geometric Mean
2787019|NCT00615017|Secondary|AUC(0-12) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg.h/mL||Full Range|Geometric Mean
2787020|NCT00615017|Secondary|Total Apparent Clearance (CL) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|CL of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||mL/min/kg||Full Range|Mean
2787021|NCT00615017|Secondary|Terminal Half-life (t1/2) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|t1/2 of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||Hours||Full Range|Mean
2787022|NCT00615017|Secondary|Area Under the Serum Concentration-time Curve From 0 to 12 Hours (AUC(0-12)) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|AUC(0-12) for single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, and 12h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg.h/mL||Full Range|Geometric Mean
2787023|NCT00615017|Secondary|Change From Baseline in Sequential Organ Failure Assessment (SOFA) Scores|Change in SOFA (Sequential Organ Failure Assessment) scores from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. The SOFA score is out of a maximum of 24 (units on a scale 0 to 24). The higher the score, the worse the organ system functioning. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.|||units on a scale (0 to 24)||Full Range|Mean
2787024|NCT00615017|Secondary|28-Day Mortality|The number of patients who had died at Day 28. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)||||Participants|||Number
2787025|NCT00615017|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.|||kg||Full Range|Mean
2787026|NCT00615017|Primary|Change From Baseline in Calculated Mean Arterial Blood Pressure|Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 [calculated as Day 14 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 14|Participants analyzed relates to the number of evaluable patients at the specified time point.|||mmHg||Full Range|Mean
2787027|NCT00615017|Primary|Change From Baseline in QT With Fridericia Correction (QTcF), Where QT is Measured by ECG, and is the Time Interval Between the Start of the Q Wave and the End of the T Wave in the Heart's Electrical Cycle.|Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 [calculated as Day 1 mean minus baseline mean] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo [calculated as Day 5 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 1 (end of infusion) for Cohorts 1 and 2; Day 5 (end of infusion) for Cohorts 3 to 5 and placebo|Participants analyzed relates to the number of evaluable patients at the specified time point.|||msec||Full Range|Mean
2787028|NCT00615017|Primary|Change From Baseline in Troponin I|Change in troponin I values from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μg/L||Full Range|Mean
2787030|NCT00615017|Primary|Change From Baseline in Platelet Count Values|Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||10^9/L||Full Range|Mean
2787031|NCT00615017|Primary|Change From Baseline in White Blood Cell Values|Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||10^9 cells/L||Full Range|Mean
2787032|NCT00615017|Primary|Change From Baseline in Haemoglobin Values|Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||g/L||Full Range|Mean
2787033|NCT00615017|Primary|Change From Baseline in Bilirubin Values|Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μmol/L||Full Range|Mean
2787034|NCT00615017|Primary|Change From Baseline in Aspartate Aminotransferase Values|Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μkat/L||Full Range|Mean
2787035|NCT00615017|Primary|Change From Baseline in Alanine Aminotransferase Values|Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μkat/L||Full Range|Mean
2787036|NCT00615017|Primary|Change From Baseline in Creatinine Values|Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.|||μmol/L||Full Range|Mean
2787037|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||L/h||90% Confidence Interval|Mean
2787038|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng•h/mL||90% Confidence Interval|Mean
2787039|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.|RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
2787074|NCT00614744|Secondary|Number of Infants With Non-CNS Organ System Dysfunction|Based on observing presence of organ dysfunction on at least one of the following: Pulmonary (Meconium aspiration syndrome, PPHN, Pulmonary hemorrhage, Pneumonia, Chronic lung disease, ECMO, INO), Cardiovascular (Cardiomegaly, Cardiac failure, Cardiac dysfunction (by echo), Cardiac ischemia (by EKG and/or increased enzymes), Hypotension, Arrhythmia), Renal (Oliguria, Anuria, Dialysis), Gastrointestinal (NEC, Hepatic dysfunction), Hematologic (DIC) and Metabolic (Hypoglycemia, Hypocalcemia, Hypomagnesemia)|Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
2787040|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||L/H||90% Confidence Interval|Mean
2787041|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
2787042|NCT00614991|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004."|Day 0 through Day 49||||participants|||Number
2787043|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng/mL||90% Confidence Interval|Mean
2787044|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mmol/L||Standard Error|Mean
2787045|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mmol/L||Standard Error|Mean
2787046|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mmol/L||Standard Error|Mean
2787095|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.|||Participants|||Count of Participants
2787047|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mg/dL||Standard Error|Mean
2787048|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mg/dL||Standard Error|Mean
2787049|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||mg/dL||Standard Error|Mean
2787050|NCT00614939|Secondary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline , Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.|||Percent||Standard Error|Mean
2787051|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mmol/L||Standard Error|Mean
2787052|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mmol/L||Standard Error|Mean
2787053|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mmol/L||Standard Error|Mean
2787054|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mg/dL||Standard Error|Mean
2787055|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mg/dL||Standard Error|Mean
2787130|NCT00614432|Primary|Differences is Intraoperative Blood Loss in Anticoagulated Versus Non-anticoagulated Women Receiving a Surgical Termination of Pregnancy.||Post procedure||||milliliters||Standard Deviation|Mean
2787131|NCT00614406|Primary|Menstrual Cycle Length|Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.|3 months|Intention to Treat (ITT)|||Days||Standard Deviation|Mean
2787056|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||mg/dL||Standard Error|Mean
2787057|NCT00614939|Primary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline , Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.|||Percent||Standard Error|Mean
2787058|NCT00614926|Secondary|"Number of Impaired Scores on Neuropsychological (Brief) Test Battery"|This was an initial plan but the large majority of patients were too impaired (either anarthric or unable to use hands) to complete the tests we had selected so this outcome measure turned out to be unfeasible. Therefore, 0 participants were analyzed.|4 weeks||||participants|||Number
2787059|NCT00614926|Primary|"Participants Considered Responders (Scored 1 or 2) on Clinical Global Impressions Scale"|"The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying responder and all the rest as non-responder using all available data including clinician judgement, and ratings scales."|4 weeks|Analysis was Intention to Treat (ITT) including Last-Observation-Carried-Forward (LOCF) as indicated. Proof of concept study so N was based on accrual feasibility.|||"participants considered responders"|||Number
2787060|NCT00614913|Primary|Median Survival Without Tumor Progression|Median time until disease progression or death|3 months|All participants|||months||95% Confidence Interval|Median
2787061|NCT00614913|Primary|3-year Survival Without Tumor Progression for Patients Within the Milan Criteria|Percent of participants alive and without tumor progression 3 years following treatment.|3 months|Participants that were within the Milan criteria|||percentage of participants|||Number
2787062|NCT00614874|Secondary|Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3|||percent predicted||Standard Deviation|Mean
2787063|NCT00614874|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 in liters|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3|||Liters||Standard Deviation|Mean
2787064|NCT00614874|Secondary|Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion|Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.|patients were assessed at baseline and 12 weeks|2 patients withdrew from the study in visit 3|||parts per billion||Standard Deviation|Mean
2787065|NCT00614874|Primary|Methacholine Responsiveness as Assessed by PC20,|PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%|patients were assessed at baseline and at 12 weeks|3 subjects were not included in the final analysis due to missing data. Two subjects withdrew by visit 3. 1 had missing data at visit 2 due to equipment failure.|||mg/mL||Standard Deviation|Mean
2787066|NCT00614822|Secondary|Number of Participants With Adverse Events|Measured by adverse events such as grade 4 toxicities, hospitalizations for toxicities, fever and neutropenia events, and clinically significant bleeding/thrombotic events.|Subjects were seen or contacted every 3 months with medain follow up of 49 weeks.|four patients discontinued treatment because of treatment related adverse events.|||Participants|||Count of Participants
2787067|NCT00614822|Secondary|Number of Participants With Complete and Partial Tumor Responses|A complete response (CR),was disappearance of all target lesions on CT scan and absence of appearance of any new lesion was required. Partial response (PR) was assessed by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions without appearance of any new lesions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions. Patients were assessed to have stable disease if neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, without appearance of new lesions. Patients who received one or more cycles were evaluable for response.|Patients were enrolled over a 24 month period for treatment visits. After end of treatment visits, subjects were seen or contacted every 3 months for survival data. Median follow up was 49 weeks (6 weeks to death.|Number of Participants with Complete and Partial Tumor Responses|||Participants|||Count of Participants
2787068|NCT00614822|Primary|Overall Survival|Overal survival was defined as time between the date of treatment assignment and the date of death|"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)."|Nonsquamous stage IV disease, Male, Female,>18 years of age, white, african american,with ECOG of 0 or 1|||weeks||95% Confidence Interval|Median
2787069|NCT00614822|Primary|Progression Free Survival|"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)."|"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year)."||||weeks||95% Confidence Interval|Median
2787070|NCT00614744|Secondary|Number of Infants With Neonatal Seizures, With and Without EEG Abnormalities||Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
2787071|NCT00614744|Secondary|Number of Infants With a DNR Order That Died||Birth to 18-22 months corrected gestational age|Only infants with DNR order|||Participants|||Count of Participants
2787072|NCT00614744|Secondary|Number of Infants With a DNR Order and Support is Withdrawn||Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
2787075|NCT00614744|Secondary|Number of Infants With Any Disability Based on Level of Encephalopathy at Randomization|Mild disability will be defined by either a Bayley III cognitive score of 70-84 alone or a Bayley III cognitive score >= 85 and any of the following: presence of a GMF level 1 or 2OR seizure disorder or hearing loss. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 OR Gross Motor Functional (GMF) Level of 3-5 OR blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age||||Participants|||Count of Participants
2787076|NCT00614744|Secondary|Number of Infants With Mild, Moderate and Severe Disability|Mild disability will be defined by either a Bayley III cognitive score of 70-84 alone or a Bayley III cognitive score >= 85 and any of the following: presence of a GMF level 1 or 2 OR seizure disorder or hearing loss. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 OR Gross Motor Functional (GMF) Level of 3-5 OR blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
2787077|NCT00614744|Secondary|Number of Infants With Moderate and Severe Disability|Moderate disability will be defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit. Severe disability will be defined by any of the following: a Bayley III cognitive score < 70 or Gross Motor Functional (GMF) Level of 3-5 or blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
2787078|NCT00614744|Secondary|Number of Deaths in the NICU and Following Discharge||Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
2787079|NCT00614744|Primary|Death or Moderate or Severe Disability|Severe disability was defined by any of the following: a Bayley III cognitive score < 70 or Gross Motor Functional (GMF) Level of 3-5 blindness or profound hearing loss requiring amplification but still unable to follow commands/communicate. Moderate disability was defined as a Bayley III cognitive score between 70-84 and either a GMF level of 2 or a seizure disorder or a hearing deficit.|Birth to 18-22 months corrected gestational age|Does not include 9 lost to follow up and 2 infants without outcome for behavior issues|||Participants|||Count of Participants
2787080|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
2787081|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.|||Participants|||Count of Participants
2787082|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||Participants|||Count of Participants
2787083|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During a 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
2787084|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.|||Participants|||Count of Participants
2787375|NCT00612352|Primary|Number of Drinks Felt Consumed at 140 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|140 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2787085|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
2787086|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.|||Participants|||Count of Participants
2787087|NCT00614614|Secondary|Number of Subjects Reporting Any Rash|Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.|||Participants|||Count of Participants
2787088|NCT00614614|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase|Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.|||Participants|||Count of Participants
2787089|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.|||Participants|||Count of Participants
2787090|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
2787091|NCT00614614|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||Participants|||Count of Participants
2787092|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||Participants|||Count of Participants
2787093|NCT00614614|Secondary|Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787094|NCT00614614|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.|||Participants|||Count of Participants
2787330|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 3|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787096|NCT00614614|Secondary|Anti-D and Anti-T Geometric Mean Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2787097|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||Participants|||Count of Participants
2787098|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
2787099|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||titer||95% Confidence Interval|Geometric Mean
2787100|NCT00614614|Secondary|Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||Participants|||Count of Participants
2787101|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.|||Participants|||Count of Participants
2787102|NCT00614614|Primary|Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787103|NCT00614614|Primary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.|||Participants|||Count of Participants
2787104|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
2787105|NCT00614614|Primary|Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group.|||Participants|||Count of Participants
2787106|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||titer||95% Confidence Interval|Geometric Mean
2787107|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||titer||95% Confidence Interval|Geometric Mean
2787108|NCT00614614|Primary|Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.|||Participants|||Count of Participants
2787109|NCT00614614|Primary|Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.|||Participants|||Count of Participants
2787110|NCT00614575|Primary|Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.|for 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2787111|NCT00614575|Secondary|Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.|After 12 weeks or at the time of discontinuation|Efficacy Analysis Set|||units on a scale||Standard Deviation|Mean
2787112|NCT00614575|Secondary|Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score|Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set|||Unit on a scale||Standard Deviation|Mean
2787113|NCT00614575|Secondary|Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score|The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set|||Unit on a scale||Standard Deviation|Mean
2787114|NCT00614575|Secondary|Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set|||Unit on a scale||Standard Deviation|Mean
2787115|NCT00614575|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|for 12 weeks after initiation of the treatment|Efficacy analysis set|||participants|||Number
2787116|NCT00614523|Secondary|Annualized Rate of Patient-reported Bleeding Events|"The number of bleeding events was obtained from the thrombocytopenia symptoms (Th-symptoms) survey. Patients reported spontaneous bleeding to have occurred 0, 1 or 2, 3 or 4, 5 or 6, or 7 or more times in the past week. The lower threshold of bleeding counts is used for conservative purposes (i.e., the 3 is used for the response option of 3 or 4 times). Exposure adjusted event rate per 100 patient-years = number of events / patient-year * 100."|Test Treatment Period (Weeks 1-26)|The Patient Reported Outcomes (PRO) analysis set consists of patients in the full analysis set who also completed the baseline and at least one post-baseline assessment for any PRO measure.|||events per 100 patient-years||95% Confidence Interval|Mean
2787117|NCT00614523|Secondary|Kaplan-Meier Estimate of Survival at Month 12|Overall survival was calculated using Kaplan-Meier methods.|Month 12, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.|||percentage of participants||95% Confidence Interval|Number
2787118|NCT00614523|Secondary|Time to Death|Overall survival was calculated using Kaplan-Meier methods. For patients who discontinued early, additional information from the long term follow-up are added (closest available follow-up information up to 58 weeks).|From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.|||months||95% Confidence Interval|Median
2787119|NCT00614523|Secondary|Number of Participants Who Died||From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.|||participants|||Number
2787140|NCT00614380|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Deviation|Mean
2787120|NCT00614523|Secondary|Exposure-adjusted Total Duration of Platelet Hematologic Improvement (HI-P) in the Absence of Platelet Transfusions|Duration for participants who did not report HI-P during the period is 0. A platelet hematologic improvement (HI-P) is defined by an MDS International Working criteria as patients with a baseline platelet count of ≥ 20 x 10^9/L achieving an absolute increase of ≥ 30 x 10^9/L or increasing the platelet count to above 20 x 10^9/L and by at least 100% in patients with a baseline of < 20 x 10^9/L for at least 8 consecutive weeks. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint. The durations of HI-P are cumulative if more than one incidence occurred. Exposure adjusted event rate per 100 patient-weeks = total number of weeks / patient-weeks * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||weeks per 100 patient-weeks||95% Confidence Interval|Mean
2787121|NCT00614523|Secondary|Number of Participants With Platelet Hematologic Improvement (HI-P)|Platelet Hematologic Improvemen defined by the international working group (IWG) as: an absolute increase in platelet count of ≥ 30 x 10^9/L for a patient starting with a platelet count of ≥ 20 x 10^9/L or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a patient that started with a platelet count < 20 x 10^9/L. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||Participants|||Number
2787122|NCT00614523|Secondary|Annualized Rate of Total Platelet Transfusion Units|The time from first dose of study drug to the last dose of 26-week test treatment period. A unit of platelets is defined as a single pack of pooled platelet-rich plasma comprised of 6 to 8 individual platelet concentrate packs (200 to 400 mL), a single pack of pooled buffy-coat concentrate, or 1 apheresis (single donor) concentrate. Exposure adjusted event rate per 100 patient-years = events / patient-years * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized subjects|||units per 100 patient-years||95% Confidence Interval|Mean
2787123|NCT00614523|Secondary|Annualized Rate of Overall Bleeding Events|The time from first dose of study drug to the last dose of 26-week test treatment period. A bleeding event is defined as any bleeding event reported during the test treatment period. Bleeding events that continue for more than 7 days are counted as separate events every eighth day. Multiple events that arose from one organ system on one day are collapsed into one single event. Exposure adjusted event rate per 100 patient-years = events / patient-year * 100).|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||events per 100 patient-years||95% Confidence Interval|Mean
2787124|NCT00614523|Secondary|Annualized Rate of Platelet Transfusion Events|A discrete platelet transfusion is any number of platelet transfusion administered within a 3-day period. Transfusions administered more than 3 days apart are counted as separate events. Transfusion given in the absence of any bleeding, when platelet count is >10x10^9/L, is not counted as a platelet transfusion event. Events with start date between the first dose date and the last dose date of the test treatment period +7 days are included. Exposure adjusted event rate per 100 patient-years = (events / patient-years * 100). Patient Year = total patient years of exposure to investigational product during 26 weeks test treatment period.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||events per 100 patient-years||95% Confidence Interval|Mean
2787125|NCT00614523|Primary|Number of Clinically Significant Bleeding Events|A clinically significant bleeding event is defined as any bleeding event of grade ≥ 2 per the modified World Health Organization (WHO) bleeding scale: • Grade 0 = no bleeding • Grade 1 = petechia or mucosal or retinal bleeding not requiring intervention • Grade 2 = melena, hematemesis, hematuria, hemoptysis • Grade 3 = bleeding required red cell transfusion • Grade 4 = retinal bleeding with visual impairment • Grade 5 = non-fatal cerebral bleeding • Grade 6 = fatal cerebral bleeding • Grade 7 = fatal non-cerebral bleeding. Bleeding events that continue for more than 7 days were counted as separate events every eighth day. Multiple events that arose from one organ system on one day were collapsed into one single event. Bleeding events with a start date between the first dose date and the last dose date of the test treatment period+7 days are included.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.|||events|||Number
2787126|NCT00614484|Secondary|Treatment Related Toxicities.|"grade 3 or higher esophageal toxicity~Toxicity is categorized either early or late phase.~Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter"|Monthly for duration of participant lifespan. Average lifespan 1-2 years||||participants|||Number
2787127|NCT00614484|Primary|Overall Survival.|Median survival time following treatment.|Monthly for duration of participant lifespan. Average lifespan 1-2 years||||Months||95% Confidence Interval|Median
2787128|NCT00614458|Primary|A Change in the Number of HIV Infected Cells.|A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.|20 weeks|All participants analyzed per protocol|||infected cells /million cells||95% Confidence Interval|Median
2787129|NCT00614445|Primary|Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).|The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe).|Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)|Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects [261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population].|||PUQE Score||95% Confidence Interval|Mean
2787132|NCT00614393|Secondary|Overall Response Rate (ORR) of Dalotuzumab in Combination With Cetuximab + Irinotecan Versus ORR of Cetuximab + Irinotecan Alone in Participants With Wild Type of Colorectal Cancer|ORR, using RECIST 1.0, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Every 6 weeks (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.|||Percentage of Participants|||Number
2787133|NCT00614393|Primary|Percentage of Participants Who Experience an AE of Infusion Site Reaction|The percentage of participants who experienced an AE of infusion site reaction is presented.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
2787134|NCT00614393|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The percentage of participants who discontinued study drug due to an AE is presented.|Up to last dose of study drug (Up to 32 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
2787135|NCT00614393|Primary|Percentage of Participants Who Have a Drug-related Clinical or Laboratory CTCAE Grade 3 to 5 Toxicity|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Drug-related AEs were those AEs that were possibly, probably, or definitely related to study drug or protocol-specified procedures. Participants were monitored for AEs related to dalotuzumab or placebo until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the NCI CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
2787136|NCT00614393|Primary|Percentage of Participants Who Have a Clinical or Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 to 5 Toxicity|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Participants were monitored for AEs until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the National Cancer Institute (NCI) CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The All Participants as Treated (APaT) population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.|||Percentage of Participants|||Number
2787137|NCT00614393|Primary|Progression-free Survival (PFS)|The PFS of participants with metastatic CRC expressing the wtKRAS genotype was defined as the time from the first day of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) as documented by an independent core laboratory, or death due to any cause, whichever occurred first. Disease progression was defined as either a 20% or greater relative increase in the sum of diameters of target lesions OR an absolute increase of at least 5mm in the sum of lesions or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Up to last dose of study drug (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.|||Months||Full Range|Median
2787138|NCT00614393|Primary|Overall Survival (OS)|The OS of participants with metastatic colorectal cancer (CRC) expressing the KRAS wild-type (wtKRAS) tumor genotype (indicating no detection of KRAS mutation) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and is reported in months.|Up to 12 weeks after last dose of study drug (Up to 35 months)|The Intent-to-Treat (ITT) population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.|||Months||Full Range|Median
2787139|NCT00614380|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration|At any point during open-label treatment|Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787353|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787141|NCT00614380|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Deviation|Mean
2787142|NCT00614380|Secondary|Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787143|NCT00614380|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Days||Standard Deviation|Mean
2787144|NCT00614380|Secondary|Trough Blood Pressure (BP) Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787145|NCT00614380|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787146|NCT00614380|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787147|NCT00614380|Secondary|Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in SBP in this study|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
2787148|NCT00614380|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement|||mmHg||Standard Error|Least Squares Mean
2787149|NCT00614380|Secondary|Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in DBP in this study|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement|||mmHg||Standard Error|Least Squares Mean
2787150|NCT00614380|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose|||mmHg||Standard Error|Least Squares Mean
2787151|NCT00614380|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reach the target SBP of <140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787152|NCT00614380|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reach the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose|||Participants|||Number
2787153|NCT00614315|Secondary|Number of Device/Procedure-related Adverse Events(Safety of Delivery)|Device/Procedure-related adverse events from the index procedure through 30 days post procedure|Index Procedure to 30 days||||Number of Device/Procedure events|||Number
2787154|NCT00614315|Primary|Technical Success for Delivery|defined as deployment of the implant to the intended location, assessed at the time of the index procedure.|Measured at the time of implantation (Day 0)||||Percentage of successful implantations|||Number
2787155|NCT00614198|Secondary|Changes to Appearance of Multiple Compounds in Urine Samples||Baseline - 8 months -12 months - 24 months|||||||
2787156|NCT00614198|Primary|Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.|ADOS (Autism Diagnostic Observation Schedule): module 1 cutoff scores (communication+social): autism=12, autism spectrum (AS)=7; module 2 cutoffs: autism=12, AS=8; module 3 cutoffs: autism=10; AS=7. GARS (Gilliam Autism Rating Scale): <80 low probability of autism, 81-90 below average, 91-110 average, >110 above average probability of autism. VABS (Vineland Adaptive Behaviour Scale): <69 (low ability), 70-84 (moderate/low), 85-115 (adequate), 116-130 (moderate/high), >130 (high). ADHD-IV: 0=no problems indicated. >11 attention & >11 hyperactivity = ADHD diagnosis.|Baseline - 8 months - 12 months - 24 months|Per protocol analysis. Analysis was conducted on n=26 (Gluten- and casein-free dietary intervention) and n=29 (No gluten- and casein-free dietary intervention) at 12 months. Analysis was conducted on n=18 and n=17 at 24 months (both on gluten- and casein-free dietary intervention).|||Units on a scale||Standard Error|Mean
2790102|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2787157|NCT00614120|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-16|Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products.|||episodes|||Number
2787158|NCT00614120|Secondary|Change in Fasting Lipid Profile, APO-B|Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||g/L||Standard Deviation|Median
2787159|NCT00614120|Secondary|Change in Fasting Lipid Profile|"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:~Total Cholesterol (TC)~Low-density Lipoprotein-cholesterol (LDL-C)~Very Low-density Lipoprotein-cholesterol (VLDL-C)~High-density Lipoprotein-cholesterol (HDL-C)~Triglyceride (TG)~Free Fatty Acid (FFA)"|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2787160|NCT00614120|Secondary|Change in Beta-cell Function|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point (%point)||Standard Deviation|Mean
2787161|NCT00614120|Secondary|7-point Self-measured Plasma Glucose Profiles|Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).|week 0, 8, 12 and 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dl||Standard Deviation|Mean
2787162|NCT00614120|Secondary|Change in Self-measured Fasting Plasma Glucose|Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Deviation|Mean
2787163|NCT00614120|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Deviation|Mean
2787164|NCT00614120|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Deviation|Mean
2787165|NCT00614055|Secondary|Physical Examination|Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week 0, Week 8, Week 16|||||||
2787166|NCT00614055|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||beats/minute||Standard Deviation|Mean
2787167|NCT00614055|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
2787168|NCT00614055|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
2787169|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||umol/L||Standard Deviation|Mean
2787170|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
2787171|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
2787172|NCT00614055|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787173|NCT00614055|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787174|NCT00614055|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2787175|NCT00614055|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.|||mmol/L||Standard Error|Mean
2787176|NCT00614055|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 16 weeks of treatment|Week 0, Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2787177|NCT00614055|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2787178|NCT00613951|Secondary|Physical Examination|Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 8, Week 16|||||||
2787179|NCT00613951|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.|||beats/minute||Standard Deviation|Mean
2787180|NCT00613951|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
2787181|NCT00613951|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
2787182|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.|||umol/L||Standard Deviation|Mean
2787183|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
2787184|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
2787185|NCT00613951|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2787186|NCT00613951|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787187|NCT00613951|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787188|NCT00613951|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing.|||mmol/L||Standard Error|Least Squares Mean
2787189|NCT00613951|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2787190|NCT00613938|Secondary|Total Pain Relief (TOTPAR)at 48 Hours|Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.|48 hours|Intent-to-treat|||scores on a scale||Standard Deviation|Mean
2787191|NCT00613938|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3|Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3|Baseline and 3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||percentage of participants|||Number
2787192|NCT00613938|Secondary|SPID at 24 Hours Relative to First Dose|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|24 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||Scores on a scale||Standard Deviation|Mean
2787193|NCT00613938|Secondary|The SPID at 12 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|12 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||Scores on a scale||Standard Deviation|Mean
2787194|NCT00613938|Secondary|Time to First Rescue Pain Medication Use.|The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.|3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||||||
2787195|NCT00613938|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|48 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||Scores on a scale||Standard Deviation|Mean
2787196|NCT00613925|Secondary|Sample Adequacy|adequacy of sample obtained for examination by a pathologist|at time of biopsy||||percentage of participants|||Number
2787197|NCT00613925|Primary|Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS).|"The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain in My Life (furthest point to the right)."|2 minutes after biopsy procedure|To demonstrate a 20 mm difference on the 100 mm visual analog scale, sample size of 35 women in each group (80% power, 0.05 alpha, SD 30mm)|||mm||Standard Deviation|Mean
2787198|NCT00613834|Secondary|Patient Satisfaction With the Essure Tubal Sterilization Procedure|Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.|30 minutes post-procedure||||score on a scale||Full Range|Median
2787199|NCT00613834|Secondary|Patient Perceived Pain 30 Minutes Post-procedure|Patients rated their pain 30 minutes after speculum removal using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable.|30 minutes post-procedure||||score on a scale||Full Range|Median
2787200|NCT00613834|Primary|Change in Patient-perceived Pain Between Baseline and Cannulization|Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.|Immediately after speculum insertion and immediately after cannulization||||score on a scale||Full Range|Median
2787218|NCT00613509|Secondary|Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term|"Common Terminology Criteria for Adverse Events (CTCAE) definitions:~Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event."|Day 0 to 12 months post last vaccination|Safety assessments were conducted in the As-treated safety population.|||Participants|||Number
2787201|NCT00613821|Primary|The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.|Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).|Immediately (time zero) at uterine aspiration||||mm||Standard Deviation|Mean
2787202|NCT00613730|Secondary|Percentage of Participants With Overall Response|Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|Overall study|Study was terminated after enrolling 3 participants. This outcome was not evaluated.||||||
2787203|NCT00613730|Secondary|Progression-free Survival|Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician's assessment based on symptom progression.|Up to 25 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.||||||
2787204|NCT00613730|Primary|Overall Survival at 1 Year|"The survival time is calculated from Study Day~1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause."|12 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.||||||
2787205|NCT00613626|Secondary|Assess VEGF Polymorphisms and Correlate Subject Response||24 months|This data was not collected for the safety lead-in participants.|||probability|||Number
2787206|NCT00613626|Secondary|Measure Overall Survival for Each Arm||24 months||||Months||95% Confidence Interval|Median
2787207|NCT00613626|Secondary|Measure Disease Control Rate (CR + PR+ SD) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).|24 months|12 participants were not analyzed due to missing data.|||percentage of participants||95% Confidence Interval|Number
2787208|NCT00613626|Secondary|Measure the Response Rate (CR + PR) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.|24 months|12 participants are excluded due to missing data.|||percentage of participants||95% Confidence Interval|Number
2787209|NCT00613626|Secondary|Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities|Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.|6 weeks (2 Cycles)|The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.|||percentage of participants|||Number
2787210|NCT00613626|Primary|Time to Disease Progression - Median Time to Progression and Log-Rank Test|Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.|24 months|Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)|||Months||95% Confidence Interval|Median
2787211|NCT00613574|Secondary|Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
2787212|NCT00613574|Secondary|Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
2787213|NCT00613574|Secondary|Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
2787214|NCT00613574|Secondary|Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)|Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||participants|||Number
2787215|NCT00613574|Secondary|Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks|Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites|Visit 1 to Visit 3 (baseline and 8 weeks)|Full Analysis Set (Intent-to-Treat population) and only patients from selected sites|||liters||Standard Deviation|Mean
2787216|NCT00613574|Secondary|Change From Baseline for Forced Vital Capacity After 8 Weeks|Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||liters||Standard Deviation|Mean
2787217|NCT00613574|Primary|Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks|Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)|||liters||Standard Deviation|Mean
2787219|NCT00613509|Secondary|Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.|||Weeks||Full Range|Mean
2787220|NCT00613509|Primary|Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population|Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol|Day 0 - up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.|||Weeks||Inter-Quartile Range|Median
2787221|NCT00613509|Other Pre-specified|Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)|The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.|Day 0 to 32 weeks post 1st vaccination or treatment|Immunologic responses were assessed in the per-protocol evaluable population.|||Percent Cell Count||Standard Deviation|Mean
2787222|NCT00613509|Primary|Summary of Disease Progression in Study Participants, Intent-to-treat Population|Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).|Day 0 up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.|||Participants|||Number
2787223|NCT00613509|Secondary|Best Overall Objective Response in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.|||Percentage of participants|||Number
2787224|NCT00613509|Secondary|Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.|||Particpants|||Number
2787225|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen|The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.|||Participants|||Number
2787226|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen|The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.|||Participants|||Number
2787227|NCT00613405|Secondary|Current Mood as Assessed by the Mood Form||~2 hours|||||||
2787228|NCT00613405|Secondary|Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)||~2 hours|||||||
2787229|NCT00613405|Secondary|Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR||~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).|||||||
2787230|NCT00613405|Primary|Subjective Craving of Marijuana|Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving|approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).||||Scores on a Scale||Standard Deviation|Mean
2787231|NCT00613379|Primary|Maximum Change in Viral Load Following Initiation of Treatment.|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.|||Log10copies HIV-1 RNA/mL||Standard Error|Mean
2787232|NCT00613366|Secondary|Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).|"Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|At time of IUD insertion|ITT|||mm||Standard Deviation|Mean
2787233|NCT00613366|Primary|The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).|"Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|Time of IUD insertion|Intent to Treat (ITT)|||mm||Standard Deviation|Mean
2787274|NCT00613015|Secondary|Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure|Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.|Immediately following trier + cocaine cue exposure||||mcg/dl||Standard Deviation|Mean
2787234|NCT00613327|Secondary|Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.|||Percent change||Standard Deviation|Mean
2787235|NCT00613327|Secondary|Visual Analogue Scale (VAS) Score for Dry Mouth|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth).|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.|||Units on a scale||Standard Deviation|Mean
2787236|NCT00613327|Secondary|Mean Severity of Urinary Urgency at Urination|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency.|Baseline, Week 6, 12 or ED|Data was reported in individual participant listings as planned, but not statistically summarized for analysis.||||||
2787237|NCT00613327|Secondary|Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Percent change||Standard Deviation|Mean
2787238|NCT00613327|Secondary|Frequency of Urinary Urgency and Urinary Incontinence|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Episodes per day||Standard Deviation|Mean
2787239|NCT00613327|Secondary|Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Percent change||Standard Deviation|Mean
2787240|NCT00613327|Secondary|Mean Voiding Frequency|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.|||Urinations per day||Standard Deviation|Mean
2787248|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2790103|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2787241|NCT00613327|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12|The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score - lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL.|Baseline, Week 6, 12 or early discontinuation (ED)|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.|||Units on a scale||Standard Deviation|Mean
2787242|NCT00613327|Secondary|Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire|"Participant's perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered Which of the following statements describes your bladder condition best at the moment? on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem."|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.|||Participants|||Number
2787243|NCT00613327|Secondary|Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire|The PPTB was used to assess participant's perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory.|Week 2, 4, 6 and 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.|||Participants|||Number
2787244|NCT00613327|Secondary|Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder|Participant's perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2787245|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2787246|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2787247|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2787293|NCT00612677|Secondary|Time to Progression (TTP)|We planned to calculate the median Time to Progression of all participants.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.||||||
2787249|NCT00613327|Primary|Percentage of Participants Who Achieved Treatment Goal|Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Missing data at Week 12 were imputed using last observation carried forward (LOCF).|||Percentage of participants||95% Confidence Interval|Number
2787250|NCT00613314|Secondary|Percentage of Patients With Presence of Metabolic Risk Factor|"Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:~a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,~based on patients' Medical History"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||Percentage of patients|||Number
2787251|NCT00613314|Primary|Change in Diastolic Blood Pressure (DBP) From Baseline|Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||mmHg||Standard Deviation|Mean
2787252|NCT00613314|Primary|Change in Systolic Blood Pressure (SBP) From Baseline|Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||mmHg||Standard Deviation|Mean
2787253|NCT00613314|Primary|Response Rate at the End of 60 Day Period|"Response rate on Blood Pressure:~Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.~Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.~Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||Percentage of patients|||Number
2787254|NCT00613314|Primary|Response Rate at the End of 30 Day Period|"Response rate of Blood Pressure assessed in the following categories:~Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline~Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|End of 30 day Period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available|||Percentage of patients|||Number
2787255|NCT00613301|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (295) means a population who have the assessment of Modified Hoehn & Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.|||Unit on a scale||Standard Deviation|Mean
2787256|NCT00613301|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.|||Unit on a scale||Standard Deviation|Mean
2787257|NCT00613301|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|after 36 months treatment|There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn’t suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.|||Participants|||Number
2787258|NCT00613301|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.|during 36 months|364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.|||Proportion (percentage of participants)|||Number
2787259|NCT00613106|Primary|Number of Participants With Treatment Emergent Adverse Events|"The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as Has anything bothered you since your last visit or is anything bothering you now? Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event."|28 weeks||||participants|||Number
2787260|NCT00613080|Secondary|Number of Patients Who Underwent Abdominoperineal Resection|All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.|Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.|Eligible patients that had surgery|||Participants|||Count of Participants
2787294|NCT00612677|Primary|Number of Patients Who Responded to Treatment|We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.||||||
2787261|NCT00613080|Secondary|Disease-free Survival: 4-year Rate|Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2787262|NCT00613080|Secondary|Overall Survival: 4-year Rate|Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2787263|NCT00613080|Secondary|Distant Failure: 4-year Rate|Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2787264|NCT00613080|Secondary|Local-regional Failure: 4-year Rate|Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.|From registration to four years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2787265|NCT00613080|Secondary|Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0|Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;|From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.|For the four time periods reported, respectively: all registered patients; patients that had surgery; patients that had surgery and postoperative chemotherapy; all registered patients.|||percentage of participants||95% Confidence Interval|Number
2787266|NCT00613080|Secondary|Number of Patients With Pathologic Complete Response|Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.|At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.|Eligible patients who started study treatment|||Participants|||Count of Participants
2787267|NCT00613080|Secondary|Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning|Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.|Pretreatment|Eligible patients who started study treatment|||Participants|||Count of Participants
2787268|NCT00613080|Primary|The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively|The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.|From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)|Eligible subjects who started study treatment.|||percentage of patients||90% Confidence Interval|Number
2787269|NCT00613028|Secondary|Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|Incidence of ≥Grade 3 treatment related, non-hematologic toxicity|41 months||||participants|||Number
2787270|NCT00613028|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|41 months||||weeks||95% Confidence Interval|Median
2787271|NCT00613028|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|41 months||||weeks||95% Confidence Interval|Median
2787272|NCT00613028|Secondary|Radiographic Response|Percentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|41 months||||percentage of participants|||Number
2787273|NCT00613028|Primary|The Primary Outcome Measure is 6 Month Progression-free Survival.|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months||||percentage of participants||95% Confidence Interval|Number
2787275|NCT00613015|Primary|Cocaine Craving|Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.|Post Trier social stress task + Cocaine Cue 2:30 pm||||units on a scale||Standard Deviation|Mean
2787276|NCT00612924|Primary|Freedom From Major Adverse Events|"The reported values represent the patients that did not experience a Major Adverse Event.~Participants did NOT experience:~All-Cause Mortality~Myocardial Infarction (MI)~Cerebrovascular Accident (CVA)~Renal Failure~Respiratory Failure~Paralysis or Paraplegia, or~Bowel Ischemia"|30 days|One Anaconda patient is not included in the analysis because their 30 day data was not reported.|||percentage of patients||95% Confidence Interval|Number
2787277|NCT00612924|Secondary|Secondary Effectiveness, Technical Success|Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations.|24 hours|151 subjects (81 Anaconda and 70 ONE-LOK) had imaging available for core lab review and determination of technical success.|||participants|||Number
2787278|NCT00612924|Primary|Successful Aneurysm Treatment|"defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of:~Aneurysm growth ≥ 5 mm as evaluated by the core laboratory~Post-operative interventions to correct type I or III endoleaks~Conversion to open surgical repair~Failed patency of both limbs~Migration requiring secondary procedure or intervention~Significant fracture~Aneurysm rupture"|365 days|In the ONE-LOK™ population, 85 subjects had efficacy endpoints and 9 subjects are missing due to withdrawal prior to 365-day follow-up. For the Anaconda population, 95 subjects had efficacy endpoints and 6 are missing data due to withdrawal prior to the 365-day follow-up.|||percentage of patients||95% Confidence Interval|Number
2787279|NCT00612807|Secondary|Beck Anxiety Inventory||pre-treatment, post-treatment, 6 month follow-up|||||||
2787280|NCT00612807|Secondary|Personal Assessment of Intimacy in Relationships||pre-treatment, post-treatment, 6 month-followup|||||||
2787281|NCT00612807|Secondary|SCID Mood Disorders||pre-treatment, post-treatment, 6 month follow-up|||||||
2787282|NCT00612807|Secondary|Conflict Tactics Scale||pre-treatment, post-treatment, 6 month follow-up|||||||
2787283|NCT00612807|Secondary|Frequency & Acceptability of Partner Behavior||Pre-treatment, post-treatment, 6 month follow-up|||||||
2787284|NCT00612807|Primary|Dyadic Adjustment Scale (DAS)|The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.|pre-treatment, monthly, post-treatment, 6 month follow-up||||Score on DAS measure||Standard Deviation|Mean
2787285|NCT00612807|Primary|Hamilton Depression Rating Scale (HDRS)|The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.|pre-treatment, monthly, post-treatment, 6 month follow-up||||Score on HDRS||Standard Deviation|Mean
2787286|NCT00612768|Secondary|Frequency of Late and Persistent Reactions|Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application|Day 2 (48 hours after application) through Day 21||||percentage of subjects with reactions|||Number
2787287|NCT00612768|Secondary|Irritation, Adhesion, Itching/Burning|Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.|Visit 2: 48 hours after patch application||||percentage of participants|||Number
2787288|NCT00612768|Primary|Agreement Between TRUE Test Allergen and Reference Allergen|Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen|Up to 21 days|The data from all enrolled subjects was analyzed.|||percentage of agreement||95% Confidence Interval|Number
2787289|NCT00612768|Primary|Analysis of Bioequivalence: Concordance|Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit|Up to 21 days|The data from 50 subjects enrolled in the study was analyzed|||percentage of agreement||95% Confidence Interval|Number
2787290|NCT00612690|Secondary|The Academic Competence Evaluation Scale (ACES)|The ACES is a teacher rating scale that describes a set of behaviors and attitudes measuring teachers' perceptions of student's academic competence and performance. The scale consists of 30 items rated on a 5-point scale (1 = Never, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Almost Always). The total score was reported as a mean per item with higher scores indicating better academic competence. Scores could range from 1 to 30.|Measured at pre- and post-school year for 3 years|Only children with available data were included in the analyses.|||units on a scale||Standard Deviation|Mean
2787291|NCT00612690|Primary|Social Skills Rating System (Parent Report)|This rating scale was completed by parents to assess how frequently their child engaged in a range of disruptive, prosocial, and academic behaviors (0 = Never to 2 = Very Often). Normative data are provided by age and sex and the measure was standardized on a heterogeneous population of which one third were urban and 28% were minorities. The scale score, Social Skills, was the primary outcome measure. Scores are rated on a scale of 0 (Never) to 2 (Very Often). The scale score, Social Skills, containing 38 items, was the primary outcome measure. Scores range from 0 to 76 with higher scores indicating improved social skills.|Measured at pre- and post-school year for 3 years|Child participants with available data were included.|||units on a scale||Standard Deviation|Mean
2787292|NCT00612677|Secondary|Number of Participants Who Experienced Toxicities|We planned to determine the safety of the regimen (Drug Toxicities) assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.||||||
2787298|NCT00612573|Primary|Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population|IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.|Week 12|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
2787299|NCT00612560|Secondary|Growth Hormone Serum Levels IGF-1|Mean serum level IGF-1(pg/ml)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis|||pg/ml||Standard Deviation|Mean
2787300|NCT00612560|Primary|Human Epidermal Growth Factor Receptor 2 (Her2) Expression|Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis.|||percentage of cells||Standard Deviation|Mean
2787301|NCT00612560|Primary|Progesterone Receptor (PR) Expression|Mean percentage of cells expressing PR|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis|||percentage of cells||Standard Deviation|Mean
2787302|NCT00612560|Primary|Expression of Estrogen Receptor (ER-beta)|Mean percentage of cells expressing estrogen receptor (ER-beta)|Biopsy/Week 1 and Surgical Resection/Week 2|All treated and eligible patients with a large enough of a sample for analysis|||percentage of cells||Standard Deviation|Mean
2787303|NCT00612534|Primary|SPID-12|SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.|12 hours after first dose|One patient in Sufentanil NanoTab 10 mcg group received the incorrect treatment so was not included in efficacy analysis|||units on a scale||Standard Error|Least Squares Mean
2787304|NCT00612508|Secondary|Adverse Events|Self-reported treatment-related and serious adverse events|over 168 days|All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event|||participants|||Number
2787305|NCT00612508|Primary|Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.|Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days|baseline, 84 days, 168 days|"A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).~The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)"|||mm||Standard Deviation|Mean
2787306|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Area Under Concentration Time-curve From Time Zero to 6 Hours (AUC [0-6)]|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter AUC (0-6) at Day 15 and Day 22.|Day 15 and Day 22|Pharmacokinetic population. Only those participants available at the specified time points were used for analysis.|||nanograms per hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2787307|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Time of Occurrence of Cmax (Tmax)|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter tmax at Day 15 and Day 22.|Day 15 and Day 22|Pharmacokinetic population. Only those participants available at the specified time points were used for analysis.|||hour||Full Range|Median
2787308|NCT00612456|Secondary|Plasma Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)|Blood samples for analysis of plasma pazopanib concentrations were collected over 6 hours after an ocular dose of pazopanib on Day 15 or Day 22. PK analyses of plasma pazopanib concentration-time data were conducted using non-compartmental Model 200 (for extravascular administration) of WinNonlin Professional Edition version 5.2. Data has been presented for pharmacokinetic parameter Cmax at Day 15 and Day 22.|Day 15 and Day 22|The pharmacokinetic population included all participants in the Safety Population who received at least one dose of active treatment and a PK sample was obtained and analyzed. Only those participants available at the specified time points were used for analysis.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2787309|NCT00612456|Secondary|Change From Baseline in Neovascular Size, Total Lesion Size, Fluorescein Angiography (FA) Leakage Area of Measurement, FA Blood Area of Measurement as Measured by FA at Day 29|FA uses FP to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling or circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. The parameters assessed were CNV size, Classic CNV size, FA blood area of measurement, FA leakage area of measurement and total lesion size. A protocol fluorescein angiogram was to be obtained at Day 29. Images were evaluated by investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for change from baseline in change in eye characteristics in the study eye at Day 29. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|PD Parameter Population. Only those participants available at the specified time point were analyzed.|||millimeters||Standard Deviation|Mean
2787310|NCT00612456|Secondary|Number of Participants With Change in Characteristics (Fibrosis, Atrophy, Blood) as Measured by Fundus Photography (FP)|Fundus photography involves capturing of images of the center of the very back inner wall of the eye — the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme subretinal hemorrhage (absence or presence at the location), heme intraretinal hemorrhage (absence or presence at the location), subretinal fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment ((absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.|Day 29|PD Parameter Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2787311|NCT00612456|Secondary|Number of Participants With Change in Retinal Morphology (Cystoid Spaces, Subretinal Fluid and Retinal Pigment Epithelial Detachment) as Determined by OCT|OCT was used for the determination of retinal morphology changes in the study eye which included assessments of cystoids spaces (cyst like spaces in the inner layers of the retina), subretinal fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and pigment epithelial detachment (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Data has been presented for number of participants with retinal morphology changes in the study eye at Day 29.|Day 29|PD Parameter Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2787312|NCT00612456|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) [Number of Letter Read on Standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) Charts at Day 29|BCVA was measured in the study eye using the ETDRS grading charts consists of at least 24 to 78 letters placed at a test distance of 4 meters. There were 7 cut off points in visual acuity on ETDRS grading chart: 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. Grade 15 to 29 indicates no impairment in vision and grade -15 to -29 indicates worst impairment in vision. Analyses were done for two sub-efficacy-populations. One sub-efficacy population included all participants in the efficacy population with a YES for retinal angiomatous proliferation (RAP)/retinal choroidal anastomosis (RCA) NONE field from Digital angiography reading center (DARC) FA form in study eye. The other included all participants in the efficacy population with a YES for eligible field from DARC FA form in study eye. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline calculated as subtracting the Baseline value from the value at Day 29.|Baseline (Day -3 to -1) and Day 29|Efficacy population comprised of all participants in the Safety Population who completed at least 7 days of pazopanib eye drop treatment and provided VA measurements and had CNV present as detected by FA. Only those participants available at the specified time points were included for analysis.|||Scores on scale||Standard Deviation|Mean
2787313|NCT00612456|Secondary|Number of Participants With Ocular Adverse Events, Non-ocular Adverse Events, Serious Ocular Adverse Events and Serious Non-ocular Adverse Events|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Data has been presented for number of participants with ocular and non-ocular adverse events and serious adverse event|Up to follow-up (Day 43)|Safety population|||Participants|||Count of Participants
2787314|NCT00612456|Secondary|Number of Participants With Abnormal Urinalysis Data by Dipstick Analysis|Urinalysis included analysis for urine occult blood, urine glucose, urine ketones and urine proteins via dipstick analysis. Data has been presented for number of participants with abnormal urinalysis results. Only categories with values have been presented.|Day 29 and follow-up (Day 43)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2787315|NCT00612456|Secondary|Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern|Clinical chemistry parameters assessed included blood urea nitrogen, potassium, calcium, albumin, creatinine, chloride, sodium, total protein, glucose, total carbon dioxide, aspartate amino transferase, alanine amino transferase, direct bilirubin, total bilirubin, alkaline phosphatase and hematology parameters assessed included platelet count, white blood cell count, red blood cell count, reticulocyte count, hemoglobin, mean corpuscle volume, mean corpuscle hemoglobin, mean corpuscle hemoglobin concentration, total neutrophils, lymphocytes, monocytes, eosinophils, basophils. Data has been presented for the number of participants with values high and low of potential clinical concern for clinical chemistry and hematology.|Up to follow-up Day 43|Safety population.|||Participants|||Count of Participants
2787316|NCT00612456|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|Single 12-lead ECGs were to be obtained at each Day 15 and follow-up Day 43 using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. ECG findings were defined as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). Data has been presented for the number of participants with A-NCS and A-CS findings.|Day 15 and follow-up (Day 43)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2787329|NCT00612352|Secondary|Hopkins Verbal Learning Task - Delay Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Delay Recall: 30 minutes after Trials 1-3 were given) (0 no words recalled - 12 all words recalled)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787374|NCT00612352|Primary|Number of Drinks Felt Consumed at 170 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|170 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2787317|NCT00612456|Secondary|Number of Participants With Vital Sign Data for Systolic Blood Pressure and Diastolic Blood Pressure and Heart Rate of Potential Clinical Concern|Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was <85 and > 160 millimeters of mercury, diastolic blood pressure <45 and > 100 millimeters of mercury, heart rate <40 and >110 beats per minute. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important findings at any visit were reported.|Up to follow up (Day 46)|Safety population.|||Participants|||Count of Participants
2787318|NCT00612456|Secondary|Number of Participants With Complete Ophthalmic Examination Values of Potential Clinical Concern|A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 43.|Upto follow-up (Day 43)|Safety population comprised of all participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2787319|NCT00612456|Primary|Mean Change From Baseline in Central Retinal/Lesion Thickness (CRLT) as Measured by the Carl Zeiss Meditec Stratus Optical Coherence Tomography (OCT) Scanner at Day 29|CRLT was measured by the Carl Zeiss Meditec Stratus OCT scanner based on the manual measurement of the distance between the inner and outer retina, inclusive of subretinal fluid and any choroidal neovascularization (CNV) as measured in the central 1 millimeter (mm) area of the 7 mm Posterior Pole Scan. OCT scans/images were collected by trained and certified photographer and analyzed by investigator. Two datasets were used for analysis namely Last observation carried forward (LOCF) which included missing assessment for a participant who completed at least 7 days of pazopanib eye drop replaced by the last non-missing assessment post 7 days of pazopanib eye drop treatment. OC dataset included a missing assessment at any scheduled time was considered unevaluable and was not imputed. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|Pharmacodynamics (PD) parameters population comprised of all participants in the Safety Population and had Choroidal Neovascularization (CNV) present as detected by Fluorescein Angiography (FA). LOCF and OC dataset were used for analysis. Only those participants with data available at the indicated time point were included for analysis.|||Microns||Standard Deviation|Mean
2787320|NCT00612430|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|median of 91.4 weeks||||weeks||95% Confidence Interval|Median
2787321|NCT00612430|Secondary|Median Progression-Free Survival|Time in weeks from the start of study treatment to the date of first progression, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 91.4 weeks||||weeks||95% Confidence Interval|Median
2787322|NCT00612430|Secondary|Safety of Study Treatment Regimen|Number of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment.|2 years||||participants|||Number
2787323|NCT00612430|Secondary|Objective Response Rate|The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required.|2 years||||percentage of participants|||Number
2787324|NCT00612430|Primary|6 Month Progression-Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.|6 months||||percentage of participants||95% Confidence Interval|Number
2787325|NCT00612352|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|30 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787326|NCT00612352|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787327|NCT00612352|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|30 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787328|NCT00612352|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787331|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 2|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787332|NCT00612352|Secondary|Hopkins Verbal Learning Task - Immediate Recall - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)|30 minutes - Trial 1|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787333|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 230 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787334|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 170 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787335|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 140 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787336|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 110 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787337|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 60 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787338|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 30 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787339|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - 10 Minutes|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787340|NCT00612352|Secondary|Visual Analog Scale (VAS) Drowsy - Baseline|visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787341|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 240 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|240 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787342|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 170 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787343|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 140 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787344|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 110 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787345|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 60 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787346|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 30 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787347|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - 10 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787348|NCT00612352|Secondary|Visual Analog Scale (VAS) HIGH - Baseline|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787349|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|240 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787350|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787351|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787352|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2789096|NCT00601965|Primary|Penn State Worry Questionnaire|The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.|56 weeks||||units on a scale||Standard Deviation|Mean
2787354|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787355|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787356|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787357|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787358|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787359|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787360|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787361|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787362|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787363|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787364|NCT00612352|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787365|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 230 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787366|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 170 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787367|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 140 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|140 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787368|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 110 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787369|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 60 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787370|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - 30 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787371|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol -10 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|10 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787372|NCT00612352|Primary|Visual Analog Scale of Similarity to Alcohol - Baseline|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787373|NCT00612352|Primary|Number of Drinks Felt Consumed at 230 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|230 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2789123|NCT00601718|Primary|Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy||3-5 weeks post end of treatment||||Participants|||Count of Participants
2787376|NCT00612352|Primary|Number of Drinks Felt Consumed at 110 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|110 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2787377|NCT00612352|Primary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2787378|NCT00612352|Primary|Number of Drinks Felt Consumed at 10 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|10 minutes|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2787379|NCT00612352|Primary|Number of Drinks Felt Consumed at Baseline|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|Baseline|All available data was utilized in the analysis using mixed models.|||drinks felt consumed||Standard Deviation|Mean
2787380|NCT00612339|Primary|Response Rate|The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|4 months|All subjects|||percentage of patients||95% Confidence Interval|Number
2787381|NCT00612313|Primary|Remission|Remission is defined as CDRS-R <=28.|Measured at Weeks 12, 18, 24, and 30||||probability of remitting (%)|||Number
2787382|NCT00612313|Secondary|Relapse|"Up through week 30, relapse was defined as:~1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration.~From week 31-78, relapse was assessed using the K-Life. Relapse was defined as at least 2 weeks of a K-Life rating of 5 or 6; participants may also be identified as relapsing with a K-Life rating of 4 if the rating was for several weeks and not strictly related to stressful life events."|Weeks 52 and 78|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.|||Probability of Relapse (%)|||Number
2787383|NCT00612313|Secondary|Remission|Remission is defined as CDRS-R <=28 (up through week 30) or at least 8 consecutive weeks of a K-Life rating of 1 or 2. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|Weeks 52 and 78||||Probability of remission (%)|||Number
2787384|NCT00612313|Secondary|K-Life (Time Well)|"K-Life interview was conducted at Weeks 6, 12, 18, 24, and 30, with ratings for depressive illness for each week throughout the study.~Ratings definitions: 1=Normal, no residual symptoms; 2=Presence of 1 or more symptosm in no more than mild degree; 3=Considerably less psychopathology than full criteria, but still obvious evidence of disorder with no more than moderate impairment; 4=Does not meet full criteria, but has major symptoms or impairment from the disorder; 5=Meets full criteria, but no extreme impairment; 6=Meets full criteria, and either has prominent psychotic symptoms or extreme impairment.~Time well is defined as each week the depression rating was a 1 or 2. Percent time well was defined as each week the depression rating was a 1 or 2 divided by the total number of weeks in the study.~Statistic: anova"|30 weeks||||Weeks spent well||Standard Deviation|Mean
2787385|NCT00612313|Primary|Relapse|"Relapse was defined as:~1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration."|Measured at Weeks 12, 18, 24, and 30|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.|||probability of relapse (%)|||Number
2787386|NCT00612313|Primary|Time to Remission|Remission is defined as CDRS-R <=28. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|30 weeks||||weeks||Standard Error|Mean
2787387|NCT00612235|Primary|Proportion of Women With PMDD in WWE and the Control Group|Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria.|Assessment of PMDD Designation after two consecutive menstrual cycles||||Participants|||Count of Participants
2787388|NCT00612235|Primary|To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.|Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria|Assessment of PMDD Designation after two consecutive menstrual cycles||||Participants|||Count of Participants
2787389|NCT00612222|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|15 months||||Participants|||Number
2787390|NCT00612222|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.||||||
2789124|NCT00601718|Primary|Safety and Toxicity According to CTCAE v3.0|Common dose limiting toxicities.|3-5 weeks post end of treatment||||Participants|||Count of Participants
2787391|NCT00612222|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met||||Participants|||Number
2787392|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Unclassifiable"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants who could not be specifically differentiated in any of the other three subtypes were stratified as unclassifiable meaning that the participants could not be classified into any of the predefined PHN subtypes. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
2787393|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Deafferentation Type 2 (D Type 2)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss and severe spontaneous burning pain without allodynia associated with reorganization of central nerve fibers were stratified in the deafferentation type 2 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
2787394|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) SubtypeDeafferentation Type 1 (D Type 1)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss associated with severe burning pain upon slight mechanical stimuli (allodynia) were stratified in the deafferentation type 1 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
2787395|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Irritable Nociceptors"|"Participants were stratified into four different PHN subtypes based on the NPPE. Participants with pain, abnormal sensitization of the specific receptor (irritable nociceptors), and with minimal sensory loss were stratified in theirritable nociceptors subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.|||Scores on a scale||Standard Deviation|Mean
2787396|NCT00612105|Secondary|"Number of Participants With Indicated Responses at the End of the MP to the Questions: How Sharp Was the Affected Side Compared to the Opposite Side? and How Painful Was the Affected Side Compared to the Opposite Side? in an Assessment of Hyperalgesia"|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions:How sharp was the affected side compared to the opposite side? and How painful was the affected side compared to the opposite side?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
2787397|NCT00612105|Secondary|"Number of Participants With the Indicated Responses at the End of the MP to the Questions of Is it Cool? and Is it Painful? in an Assessment of Cold Threshold and Allodynia"|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
2787398|NCT00612105|Secondary|"Number of Participants With the Indicated Responses at the End of the MP to the Question: How Painful Was the Affected Side Compared to the Opposite Side? in an Assessment of Tactile Allodynia"|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side? End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP."|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
2787415|NCT00612066|Primary|Number of Responders|"Definition of Treatment Response~The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression.~Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression)."|7 weeks|Sample size was too small to do a valid analysis.|||participants|||Number
2787399|NCT00612105|Secondary|"Number of Subjects With the Indicated Responses at Baseline to the Questions: How Sharp Was the Affected Side Compared to the Opposite Side? and How Painfule Was the Affected Side Compared to the Opposite Side? in an Assessment of Hyperalgesia"|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions: How sharp was the affected side compared to the opposite side? and How painfule was the affected side compared to the opposite side?"|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Participants|||Number
2787400|NCT00612105|Secondary|"Number of Participants With the Indicated Responses at Baseline to the Questions of Is it Cool? and Is it Painful? in an Assessment of Cold Threshold and Allodynia"|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|Timeframe: Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Participants|||Number
2787401|NCT00612105|Secondary|"Number of Participants With the Indicated Responses at Baseline to the Question: How Painful Was the Affected Side Compared to the Opposite Side? in an Assessment of Tactile Allodynia"|"At Baseline, the investigator conducted the Neuropathic Pain Physical Examination (NPPE) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side?."|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Participants|||Number
2787402|NCT00612105|Secondary|Scores for Reported Health Transition at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|"The least square (LS) mean score for reported health transition was calculated based on the scores (ranging from 1 to 5) given by the participant in answer to the following question: Compared to 1 year ago, how would you rate your health in general now?. Lower numbers represent a better state of health."|End of maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Error|Least Squares Mean
2787403|NCT00612105|Secondary|Scores on the Medical Outcomes Short Form-36 (SF-36) at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|Least square (LS) mean calculated based on participant's assessment of SF-36,a quality of life questionnaire consisting of 36 items grouped into 8 domains. These 8 domains further grouped into 2 overall summary measures,physical health and mental health. Higher scores on SF-36 represented better state of health. Physical/mental components summarized the data of all the physical/mental domains of SF-36 and higher scores represented better state of health.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Error|Least Squares Mean
2787404|NCT00612105|Secondary|Scores on the Brief Pain Inventory-Short Form (BPI-SF) at the End of the MP for All Participants Who Completed Week-4 of the MP and Who Terminated Early During the MP|The BPI-SF assessed pain intensity, pain relief from medication, and pain interference with function over the previous 24 hours. Pain intensity was assessed by the mean of 4 intensity items rated on a 0-10 categorical scale: 0=no pain, 10=pain as bad as you can imagine. Pain interference was assessed by determining the mean of the 7 interference items on a 0-10 categorical scale ranging from 0=does not interfere to 10=completely interferes. The level of pain relief provided by treatment was assessed on an 11-point categorical scale ranging from 0% to 100%|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Deviation|Mean
2787405|NCT00612105|Secondary|Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) at the End of the Maintenance Phase|The TSQM assessed the participant's overall satisfaction with treatment, including subscales to assess effectiveness, side effects, convenience, and global satisfaction. Raw scores from the scale were transformed into a numeric scale ranging from 0 to 100, where higher scores indicated greater satisfaction with treatment. TSQM was reported at the end of the MP. Participants who completed Week 4 of the MP and who terminated early during the MP were assessed.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.|||Scores on a scale||Standard Deviation|Mean
2787406|NCT00612105|Secondary|Number of Participants With the Indicated Overall Patient Global Impression of Change (PGIC)|For the PGIC assessment, participants were asked to assess their overall status since they initiated the study drug to the end of the Maintenance Phase using a 7-point categorical scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. All participants who completed Week 4 of the Maintenance Phase and participants who terminated early during the Maintenance Phase were assessed.|Baseline to the end of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
2787487|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 230 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787407|NCT00612105|Secondary|Number of Participants With the Indicated Change From Baseline to the End of the Maintenance Phase in Optimal Sleep Based on the Sleep Quantity Domain of the MOS Sleep Scale|"Optimal Sleep was based on the Sleep Quantity domain of the MOS Sleep Scale and included the options of Yes if sleep quantity was 7-8 hours, and No otherwise. Improved indicated a change in response of no at baseline to yes at the end of the MP, Same indicated no change in response, and Worse indicated a change in response from yes at baseline to no at the end of the MP."|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Participants|||Number
2787408|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Sleep Quantity|Change from Baseline in sleep quantity was calculated by subtracting the average value of sleep quantity, calculated in hours, at the end of the MP from the average Baseline value.|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Hours||Standard Deviation|Mean
2787409|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Medical Outcomes Study (MOS) Sleep Scale Scores|Change from BL (average value of MOS Sleep Scale score including Overall Sleep Problem [OSP] Index at end of MP minus average BL value) to the end of the MP was summarized for the OSP Index, in addition to the following subscales of the MOS Sleep Scale: Sleep Disturbance; Sleep Adequacy; Snoring; Awakening with Shortness of Breath or with a Headache; Somnolence; and Optimal Sleep. Each item was transformed to a scale with a range of 0-100. For each subscale, except Optimal Sleep, higher scores indicate a greater level of what was being measured (i.e., more snoring, more sleep adequacy, etc.).|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.|||Scores on a scale||Standard Deviation|Mean
2787410|NCT00612105|Secondary|Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase|Responders were defined as participants achieving a mean >=50% or >=30% pain reduction based on the NRS score from Baseline to the last 7 days of the MP. Those participants who did not have at least 3 diary entries in the MP, those who withdrew during the Titration Phase (TP), and non-completers (NC: who did not complete the study) were classified as non-responders. The number of responders and responders including non-completers from Baseline to the last 7 days of the MP were reported.|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. All participants providing data for this analysis had to have 7 available baseline diary entries.|||Participants|||Number
2787411|NCT00612105|Secondary|Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)|Least square mean (LSM) of pain intensity was calculated from the NRS score entered by the participants in their diaries at each week during the MP. Participants rated their pain during the previous 24 hours at all clinic visits using an NRS: 0, no pain; 1-3, mild; 4-6, moderate; 7-10 (worst possible pain), severe pain. Change from Baseline was calculated by subtracting the value of the average of the LSM of the NRS score at each week during the MP (the last 7 available diary entries in the MP were used, provided at least 3 existed) from the average Baseline value of the LSM of the NRS score.|Baseline and Weeks 1, 2, 3, and 4 (MP)|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Scores on a scale||Standard Deviation|Mean
2787412|NCT00612105|Secondary|Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)|Participants recorded the number of acetaminophen tablets taken during the previous 24 hours in a participant diary. Rescue medication was summarized as the mean number of doses taken per day during each week of the Maintenance Phase (MP) and the mean number of doses taken during all MP weeks.|Weeks 1, 2, 3, and 4 Maintenance Phase|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Tablets/Day||Standard Deviation|Mean
2787413|NCT00612105|Secondary|Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment|Participants rated their pain during the previous 24 hours at all clinic visits using an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain (10=worst possible pain). Change in In-clinic Pain Assessment was calculated by subtracting the average score on the NRS at Week 2 and Week 4 (values for each week were observed cases) of the MP from the average score on the NRS at Baseline (the last non-missing measurement prior to taking study drug).|Baseline and Weeks 2 and 4 (Maintenance Phase - MP)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy assessment. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.|||Scores on a scale||Standard Deviation|Mean
2787414|NCT00612105|Primary|Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.|Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.|Baseline and Week 4 (Maintenance Phase-MP)|Per Protocol (PP) Population: all randomized participants who completed the Titration Phase, had at least 1 dose of treatment in the MP, had at least 3 diary entries in the MP, and did not have any protocol violations or any major protocol deviations|||Scores on a scale||Standard Error|Least Squares Mean
2787416|NCT00612040|Secondary|Physical Examination|Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -1, Week 8, Week 16|||||||
2787417|NCT00612040|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.|||beats/minute||Standard Deviation|Mean
2787418|NCT00612040|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
2787419|NCT00612040|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.|||mmHg||Standard Deviation|Mean
2787420|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.|||umol/L||Standard Deviation|Mean
2787421|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
2787422|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.|||IU/L||Standard Deviation|Mean
2787423|NCT00612040|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2787424|NCT00612040|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787425|NCT00612040|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787426|NCT00612040|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
2787427|NCT00612040|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Deviation|Mean
2787428|NCT00612040|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2787429|NCT00611923|Other Pre-specified|Change in Premenstrual Symptoms as Measured by the Patient Global Premenstrual Symptoms as Measured by the Patient Global Improvement Scale at Month 1 and Month 2|Scale range in 1-7. 1 is very much improved, 4 is no change, and 7 is very much worse.|Measured at Month 1 and Month 2|12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 12 subjects taking flutamide had Patient Global Improvement Scale ratings. At the two month visit 10 subjects taking placebo and 11 subjects randomized to flutamide had Patient Global Improvement Scale ratings|||score on a scale||Standard Error|Mean
2787430|NCT00611923|Other Pre-specified|Change in Clinical Global Severity Scale|Scale range in 1-7. 1 is not at all ill, 4 is moderately ill, and 6 is severely ill and 7 is among the most extremely ill patients. Change score is calculated as Clinical Global Severity Scale score at the end of treatment month 1 or treatment month 2 minus baseline score. Negative change score is a reduction in symptoms during treatment and a positive change score is an increase in symptoms during treatment.|Measured at Month 1 and Month 2|12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide provided CGI severity ratings. At the two month visit 10 subjects taking placebo and 11subjects randomized to flutamide provided CGI severity ratings|||score on a scale||Standard Error|Mean
2787485|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 15 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787431|NCT00611923|Secondary|Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2|Scale range in 1-7. 1 is very much improved compared to baseline, 4 is no change compared to baseline, and 7 is very much worse compared to baseline.|Measured at Months 1 and 2|12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide had CGI-improvement ratings. At the two month visit 10 subjects taking placebo and 12 subjects randomized to flutamide had CGI-improvement ratings|||score on a scale||Standard Error|Mean
2787432|NCT00611923|Secondary|Side Effect Burden Measured by Side Effect Questionnaire|The Side Effects Questionnaire is a measure of combined side effect burden, including a score for frequency (0-6), intensity (0-6) and interference with function (0-6). Low score is 0, high score is 18, High score represents greater severe side effect burden|Measured at Months 1 and 2|12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide provided side effect ratings. At the two month visit 10 subjects taking placebo and 10 subjects randomized to flutamide provided side effect ratings|||score on a scale||Standard Error|Mean
2787433|NCT00611923|Secondary|Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale|DRSP low score is 21 high score is 126. High score indicates more severe symptoms. Average score for the 4 days preceding menses was calculated for each subject in each cycle. Change score is calculated as DRSP score at month 1 or month 2 minus baseline DRSP score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.|Measured at Months 1 and 2|12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 10 subjects taking placebo and 12 subjects taking flutamide provided DRSP ratings. At the two month visit 10 subjects taking placebo and 12 subjects randomized to flutamide provided DRSP ratings|||score on a scale||Standard Error|Mean
2787434|NCT00611923|Primary|Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)|Low score on PMTS scale is 0 and high score is 40. Change score is calculated as PMTS score at month 1 or month 2 minus baseline PMTS score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.|Measured at Months 1and 2|12 subjects were randomized to placebo and 13 randomized to flutamide. At the one month visit 11 subjects taking placebo and 13 subjects taking flutamide provided PMTS ratings. At the two month visit 10 subjects taking placebo and 11subjects randomized to flutamide provided PMTS ratings|||score on a scale||Standard Error|Mean
2787435|NCT00611897|Secondary|Mismatch Negativity (MMN) Duration|"Mismatch Negativity (MMN) Duration difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
2787436|NCT00611897|Secondary|Mismatch Negativity (MMN) Frequency|"Mismatch Negativity (MMN) Frequency difference waves at midline electrodes (Fx, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
2787437|NCT00611897|Primary|Novel P300|"The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
2787438|NCT00611897|Secondary|Mismatch Negativity (MMN) Intensity|"Mismatch Negativity (MMN) Intensity difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
2787439|NCT00611897|Primary|Target P300|"The Target P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol|||microvolts||Standard Error|Least Squares Mean
2787440|NCT00611884|Secondary|Physical Examination|Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 0, Week 8, Week 16|||||||
2787441|NCT00611884|Secondary|Vital Signs: Pulse|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||beats/minute||Standard Deviation|Mean
2787442|NCT00611884|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
2787443|NCT00611884|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
2787444|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||umol/L||Standard Deviation|Mean
2787445|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
2787446|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||IU/L||Standard Deviation|Mean
2787447|NCT00611884|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2787448|NCT00611884|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787449|NCT00611884|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.|||Episodes/100 years of patient exposure|||Number
2787450|NCT00611884|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
2787451|NCT00611884|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2787452|NCT00611858|Other Pre-specified|1-Year Disease-Free Survival Rate|Disease-Free Survival Rate is the percentage of participants remaining alive without disease progression.|CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
2787453|NCT00611858|Secondary|1-Year Overall Survival Rate|1-year overall survival is the percentage of participants remaining alive 1 year from study entry.|Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.||||percentage of participants||90% Confidence Interval|Number
2787454|NCT00611858|Secondary|Incidence of Grade 4 Treatment-Related Toxicity|All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.|Disease is assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.|The analysis dataset is comprised of all enrolled patients.|||Participants|||Count of Participants
2787455|NCT00611858|Secondary|Distant Recurrence Rate|Distant recurrence rate is the percentage of participants experiencing recurrence outside the pelvis.|CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
2787456|NCT00611858|Secondary|Complete Resection Rate|Complete resection rate is the percentage of participants having all gross disease removed by the surgeon at the time of operation.|Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
2787457|NCT00611858|Secondary|Local Recurrence Rate|Local recurrence rate is the percentage of participants experiencing recurrence within the pelvis.|CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
2787458|NCT00611858|Primary|Pathological Complete Response Rate|Pathological complete response (pCR) rate is the percentage of participants who achieve pCR defined as no evidence of tumor cells in the surgical specimen including the lymph nodes (down-staging to pathological T0, N0 after planned neoadjuvant therapy).|Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.|The analysis dataset is comprised of all enrolled patients.|||percentage of participants||90% Confidence Interval|Number
2787459|NCT00611806|Secondary|Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations||Measured at Week 16|||||||
2787460|NCT00611806|Secondary|Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype|The change from baseline on the Positive and Negative Syndrome Scale (PANSS) (including FOLH1, MTHRF, MTR, and COMT genotype simultaneously into a linear mixed model).The PANNS has three sub-scales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS negative and positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7 representing the negative and positive symptoms of schizophrenia, respectively, and the general psychopathology sub-scale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135) and agreed to the DNA blood draw (n = 120).|||units on a scale||95% Confidence Interval|Mean
2787461|NCT00611806|Secondary|Scale for Assessment of Negative Symptoms (SANS)|The change from baseline on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total SANS score per week, whereas a positive score represents an increase in total SANS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the SANS assessment was performed.|||units on a scale||95% Confidence Interval|Mean
2787462|NCT00611806|Secondary|Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.|||units on a scale||95% Confidence Interval|Mean
2787463|NCT00611806|Secondary|Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score||Measured at Week 16|||||||
2787464|NCT00611806|Primary|Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.|||units on a scale||95% Confidence Interval|Mean
2787465|NCT00611767|Secondary|Verbal Fluency|"Verbal Fluency Task: requires subjects to generate as many words as possible beginning with a single letter (e.g., H) during a one-minute interval. (total words in one-minute interval)"|15 minutes|All available data was utilized in the analysis using mixed models.|||number of words||Standard Deviation|Mean
2787466|NCT00611767|Secondary|Hopkins Verbal Learning Task (HVLT) - Delayed Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function with word recall at 30 minutes) (0 no words recalled - 12 all words recalled)|45 minutes|All available data was utilized in the analysis using mixed models.|||words recalled||Standard Deviation|Mean
2787486|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - Baseline|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787467|NCT00611767|Secondary|Hopkins Verbal Learning Task (HVLT) - Total Recall|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function based on word recall. (0 = no words recalled - 36 = all words recalled)|15 minutes|All available data was utilized in the analysis using mixed models.|||words recalled||Standard Deviation|Mean
2787468|NCT00611767|Secondary|Pegboard Task - 15 Minutes (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|15 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787469|NCT00611767|Secondary|Pegboard Task - Baseline (Non-Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787470|NCT00611767|Secondary|Pegboard Task - 15 Minutes (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|15 minutes|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787471|NCT00611767|Secondary|Pegboard Task - Baseline (Dominant Hand)|The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds|Baseline|All available data was utilized in the analysis using mixed models.|||seconds||Standard Deviation|Mean
2787472|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 110 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787473|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 80 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787474|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 15 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787475|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Clinician Rated - Baseline|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 20 extreme dissociative)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787476|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 110 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787477|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 80 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787478|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - 15 Minutes|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787479|NCT00611767|Secondary|Clinician Administered Dissociative Symptoms Scale - Patient Rated - Baseline|Clinician Administered Dissociative Symptoms Scale (CADSS) is a patient and Clinician rated measurement of dissociative states induced by thiopental (0 not at all dissociative - 84 extreme dissociative)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787480|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 230 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787481|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 170 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787482|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 110 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787483|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 80 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787484|NCT00611767|Secondary|Visual Analog Scales (VAS) - Anxious - 45 Minutes|visual analog scale (VAS): self-report scale used to measure anxiety (0 not at all anxious - 7 extremely anxious)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787488|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 170 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787489|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 110 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787490|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 80 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787491|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 45 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787492|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - 15 Minutes|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787493|NCT00611767|Secondary|Visual Analog Scales (VAS) - Depressed - Baseline|visual analog scale (VAS): self-report scale used to measure depressed (0 not at all depressed - 7 extremely depressed)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787494|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 230 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787495|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 170 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787496|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 110 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787497|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 80 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787498|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 45 Minutes|"visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)~."|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787499|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - 15 Minutes|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787500|NCT00611767|Secondary|Visual Analog Scales (VAS) - Drowsy - Baseline|visual analog scale (VAS): self-report scale used to measure drowsy (0 not at all drowsy - 7 extremely drowsy)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787501|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 230 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787502|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 170 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787503|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 110 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787504|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 80 Minutes|"visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)~."|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787505|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 45 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787506|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - 15 Minutes|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787507|NCT00611767|Secondary|Visual Analog Scales (VAS) - Buzzed - Baseline|visual analog scale (VAS): self-report scale used to measure buzzed (0 not at all buzzed - 7 extremely buzzed)|Baseline|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787508|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 230 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|230 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787509|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 170 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|170 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787510|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 110 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|110 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787511|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 80 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|80 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787512|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 45 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787513|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - 15 Minutes|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787514|NCT00611767|Secondary|Visual Analog Scales (VAS) - High - Baseline|visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787515|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787516|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787517|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787518|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 80 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787519|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 45 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787520|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 15 Minutes|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2787521|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline|Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787522|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 230 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787523|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787524|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant- 110 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787525|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 80 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787526|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 45 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787527|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 15 Minutes|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787528|NCT00611767|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline|Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787529|NCT00611767|Secondary|Number of Drinks Felt Consumed - 230 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|230 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2787530|NCT00611767|Secondary|Number of Drinks Felt Consumed - 170 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|170 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2787531|NCT00611767|Secondary|Number of Drinks Felt Consumed - 110 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|110 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2787532|NCT00611767|Secondary|Number of Drinks Felt Consumed - 80 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|80 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2789125|NCT00601718|Primary|Maximum Tolerated Dose of Vorinostat||28 days post last dose of study drug||||mg twice daily X 5 days|||Number
2787533|NCT00611767|Secondary|Number of Drinks Felt Consumed - 45 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|45 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2787534|NCT00611767|Secondary|Number of Drinks Felt Consumed - 15 Minutes|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|15 minutes|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2787535|NCT00611767|Secondary|Number of Drinks Felt Consumed at Baseline|The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.|Baseline|All available data was utilized in the analysis using mixed models.|||number of drinks felt consumed||Standard Deviation|Mean
2787536|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 230 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|230 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787537|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 170 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|170 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787538|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 110 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|110 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787539|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 80 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|80 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787540|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 45 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|45 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787541|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - 15 Minutes|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|15 minutes|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787542|NCT00611767|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|All available data was utilized in the analysis using mixed models.|||units on a scale||Standard Deviation|Mean
2787543|NCT00611715|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 24 weeks|All patients who received treatment and experienced an adverse event.|||participants|||Number
2787544|NCT00611715|Secondary|Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions.|at 24 weeks|Analysis population is patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.|||participants|||Number
2787545|NCT00611715|Secondary|Median Time to Progression of Target Lesions|Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Every 12 weeks from on-study to disease progression|Patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.|||Months||Full Range|Median
2787546|NCT00611715|Primary|Number of Patients With Pathological Complete Response.|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 24 weeks|Analysis population is patients who were available for response measurement. Some patients did not meet the criteria to be analyzed for response evaluation which accounts for the discrepancy in patients analyzed vs. total accrual population.|||participants|||Number
2787547|NCT00611624|Secondary|Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity|These data were not collected and were not summarized in this study. Results are not available.|Upon completion of study|||||||
2787548|NCT00611624|Primary|Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.|Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.|one year|26 participants completed the 1 year assessment.|||Participants|||Count of Participants
2787549|NCT00611559|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Up to one month after the booster dose administration||||subjects|||Number
2787550|NCT00611559|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period||||subjects|||Number
2787551|NCT00611559|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite|Within the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
2787552|NCT00611559|Secondary|Anti-poliovirus Antibodies Titer|Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||titer||95% Confidence Interval|Geometric Mean
2787553|NCT00611559|Secondary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50|Before the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787554|NCT00611559|Secondary|Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose|Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787555|NCT00611559|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose|Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787556|NCT00611559|Secondary|Anti-diphtheria and Anti-tetanus Antibodies Concentration|Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||IU/mL||95% Confidence Interval|Geometric Mean
2787557|NCT00611559|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787558|NCT00611559|Secondary|Anti-PRP Antibodies Concentration|Concentration of anti-PRP antibodies given as GMC in µg/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||µg/mL||95% Confidence Interval|Geometric Mean
2787559|NCT00611559|Secondary|Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL~Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787560|NCT00611559|Secondary|Anti-HB Antibodies Concentration|Concentration of anti-HB antibodies given as GMC in mIU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||mIU/mL||95% Confidence Interval|Geometric Mean
2787561|NCT00611559|Secondary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL~Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787562|NCT00611559|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose|Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787563|NCT00611559|Primary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787564|NCT00611559|Primary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787565|NCT00611559|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose|Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787675|NCT00610740|Secondary|Number of Patients With Measurable Peripheral Vein Concentration of dFdC|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood|30, 60, 90 minutes post uterine vein sample||||Participants|||Number
2787566|NCT00611559|Primary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose|Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)|One month after the booster dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2787567|NCT00611533|Secondary|Weight||Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.|||lb||Standard Deviation|Mean
2787568|NCT00611533|Secondary|Heart Rate||Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.|||beats/min||Standard Deviation|Mean
2787569|NCT00611533|Secondary|Blood Pressure||Baseline and after 6 weeks intervention|Participants who had least one post randomization visit.|||mm Hg||Standard Deviation|Mean
2787570|NCT00611533|Primary|BADDS Total Score|The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus.|Baseline and after 6 weeks intervention|Participants who had at least one post randomization visit.|||units on a scale||Standard Deviation|Mean
2787571|NCT00611533|Primary|Brown Attention Deficit Disorder Scale|Raw scores for 5 clusters (organizing/activating, attention/concentration, alertness/effort/processing, managing affect interference, and working memory/recall) on the BADDS were converted to T scores which range from 50-99, with higher scores meaning greater impairment.|Baseline and after 6 weeks intervention|Participants who completed both interventions.|||T score||Standard Deviation|Mean
2787572|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.|||ng*h/mL||Standard Deviation|Mean
2787573|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. However, only 13 were able to be analyzed for the renal clearance because in 5 patients the amount of topotecan measured in the urine was more than the topotecan dose that was given. Renal clearance was not calculated for those patients.|||L/h/m^2||Standard Deviation|Mean
2787574|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.|||L/h/m^2||Standard Deviation|Mean
2787575|NCT00611468|Primary|Dosage Limiting Toxicities||DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)|DLT were assessed using NCI CTCAE version 3.0. After MTD was determined, 13 additional patients were enrolled to enhance estimation of PK parameters. The first 8 were enrolled at dose 2. Because 4 of these patients experienced a DLT, the remaining 5 patients were enrolled at dose level 1. Of these, 1 experienced a DLT.|||Participants|||Number
2787576|NCT00611468|Secondary|Objective Response (as Determined Using RECIST 1.0 Criteria)||Every 6 weeks until the end of study treatment|After the determination of MTD, an additional 13 patients were enrolled to enhance estimation of PK parameters. The first 8 patients were enrolled at dose level 2, 4 of whom experienced a DLT. Thus, the remaining 5 patients were enrolled at dose 1. One of these patients experienced a DLT.|||Participants|||Number
2787577|NCT00611468|Secondary|Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)|Each subgroup lists the gene on which a polymorphism occurred (e.g., CYP3A4), the name of the polymorphism (e.g., *1), whether it was heterozygous or a variant, the number of subjects with available data, and the number who had the polymorphism.|Baseline|Pharmacokinetic studies were done for all 29 consenting patients (one of whom later withdrew).|||Participants|||Number
2787578|NCT00611468|Primary|Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib|The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).|DLT information was available for 3 patients who received a topotecan dose of 0.75 mg/M^2, for 6 patients who received a topotecan dose of 1.0 mg/M^2, and for 6 patients who recived a topotecan dose of 1.25 mg/M^2. 1 additional patient received a dose 1.0 mg/M^2 but withdrew before completing cycle 1. This patient had no DLT and was replaced.|||mg/m^2|||Number
2787579|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
2787604|NCT00611455|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
2790104|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2787580|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; Creatinine: N/A, 1.2; CO2/BCO: 0.85/0.75, 1.2/1.3; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
2787581|NCT00611455|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicated the presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787582|NCT00611455|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Months||Full Range|Median
2787583|NCT00611455|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787584|NCT00611455|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.|||Participants|||Number
2787585|NCT00611455|Secondary|Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)|Only those parameters for a particular flag (<LLN or >ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):<0.31ng/L and Serum amyloid A: <1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: >6 units; RF-IgG:>6 units; RF-IgM:>6 units; Anti-CCP:>19.9999 units; B-ls:>1343.3 ng/L; IL-6: >5 ng/L; RF:>11.9999 kilounits (KU)/L; Serum amyloid A:>82432 ng/mL.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787586|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787596|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
2787670|NCT00610883|Primary|Complete Remission|The number of patients who achieved a complete remission as a result of treatment|330 Days||||participants|||Number
2787587|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787588|NCT00611455|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787589|NCT00611455|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787590|NCT00611455|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787591|NCT00611455|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787592|NCT00611455|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787593|NCT00611455|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2787594|NCT00611455|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population|||Participants|||Number
2787595|NCT00611455|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants who were retreated from Week 24 were analyzed.|||Weeks||Standard Deviation|Mean
2787597|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
2787598|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
2787599|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
2787600|NCT00611455|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
2787601|NCT00611455|Secondary|Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period. Only those participants contributing values at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2787602|NCT00611455|Secondary|Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24|The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||nanogram per liter (ng/l)||Full Range|Median
2787603|NCT00611455|Secondary|Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||Units/Liter||Full Range|Median
2790105|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2787605|NCT00611455|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Error|Least Squares Mean
2787606|NCT00611455|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Error|Least Squares Mean
2787607|NCT00611455|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||millimeters per hour (mm/hr)||Full Range|Median
2787608|NCT00611455|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from Baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||milligrams per liter (mg/L)||Full Range|Median
2787609|NCT00611455|Secondary|Change From Baseline in HAQ-DI Score at Week 24|The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
2787610|NCT00611455|Secondary|Change From Baseline in the Physician-assessed Global Disease Score at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
2787611|NCT00611455|Secondary|Change From Baseline in Participant-assessed Global Disease Score at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
2787612|NCT00611455|Secondary|Change From Baseline in the Participant-assessed Pain Score at Week 24|"A horizontal VAS of 100 mm was used to report the participant's level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Full Range|Median
2787613|NCT00611455|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||number of swollen joints||Full Range|Median
2787671|NCT00610857|Secondary|Median Overall Survival (Point Estimate)|Median overall survival is the (point) estimate of the time corresponding to 50% estimated probability of survival.|Up to 44 months||||months||95% Confidence Interval|Median
2790125|NCT00593606|Primary|Change in Creatinine|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
2787614|NCT00611455|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||number of tender joints||Full Range|Median
2787615|NCT00611455|Secondary|Number of Participants With Clinical Remission at Week 24|Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) <2.6 at Week 24.|Week 24|ITT Population|||participants|||Number
2787616|NCT00611455|Secondary|Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||participants|||Number
2787617|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||participants|||Number
2787618|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||participants|||Number
2787619|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2787620|NCT00611455|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2787621|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2787622|NCT00611455|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2787672|NCT00610857|Secondary|1-year Overall Survival (OS)|1-year survival is the estimated probability of surviving one year expressed as a percent (probability of survival is not probability of dying).|Time from initial treatment date, up to 1 year||||percentage of patients||95% Confidence Interval|Number
2789404|NCT00599924|Secondary|Maximum Plasma Concentration (Cmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed pharmacokinetic (PK) blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
2787623|NCT00611455|Secondary|Median ACRn at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using last observation carried forward (LOCF). Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.|||percent change||Full Range|Median
2787624|NCT00611455|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
2787625|NCT00611455|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
2787626|NCT00611455|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population|||participants|||Number
2787627|NCT00611455|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.|||participants|||Number
2787628|NCT00611442|Secondary|The Number of Polyps Detected on Examination|The number of colon polyps detected during the colonoscopy.|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)||||number of polyps|||Number
2787629|NCT00611442|Secondary|Procedure Time|Procedure time refers to the total length of time required to complete the colonoscopy|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)||||minutes||Standard Deviation|Mean
2787630|NCT00611442|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.|measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)||||linkert scale (1-5)||Standard Deviation|Mean
2787631|NCT00611442|Primary|The Overall Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)||||Ottawa Score||Full Range|Mean
2787632|NCT00611403|Secondary|Change From Baseline in Goblet Cell Density of the Eyes at Month 6|Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).|||Cells per square millimeter (cells/mm^2)||Full Range|Median
2787673|NCT00610857|Secondary|Progression-free Survival (PFS)|Time from initial treatment date of to date of documented progression of disease progression (TTP)|Up to 44 months|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy|||months||95% Confidence Interval|Median
2790126|NCT00593606|Primary|Change in Chloride|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
2787633|NCT00611403|Secondary|Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6|Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2787634|NCT00611403|Primary|Percentage of Patients With Clinical Success at Month 6|Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.|Month 6|Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of < 25 mm in the 3 central regions of the eye on Day 2.|||Percentage of Patients|||Number
2787635|NCT00611351|Secondary|Event-free Survival||2 years post transplant|Number of participants at 2 years that experienced event-free survival.|||Participants|||Count of Participants
2787636|NCT00611351|Secondary|Overall Survival||2 years post transplant|Count of participants is the number of participant alive at the 2 year post transplant time point.|||Participants|||Count of Participants
2787637|NCT00611351|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)||at day 100 post transplantation|count of participants represents number of participants with documented acute GVHD prior to day 100 post transplant.|||Participants|||Count of Participants
2787638|NCT00611351|Primary|Transplantation-related Mortality at 100 Days Post-transplantation||at the 100 days post-transplant|count of participants reflects number of participants not alive at 100 days post transplant.|||Participants|||Count of Participants
2787639|NCT00611325|Secondary|Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities|Number of patients with grade 3 or greater, treatment-related, non-hematologic toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|60 months||||participants|||Number
2787640|NCT00611325|Secondary|Radiographic Response Rate|The percentage of participants with a complete or partial response at any assessment as determined by the Macdonald criteria. A confirmation of response was not required. Per Macdonald criteria, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions, no new lesions and stable or decreasing steroid dose. Objective response =CR+PR. Tumor assessments were done at baseline and at the end of each 6 week treatment cycle, and overall best response was recorded.|60 months||||percentage of participants||95% Confidence Interval|Number
2787641|NCT00611325|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause. Assessed up to 60 months.||||months||95% Confidence Interval|Median
2787642|NCT00611325|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression or death. Assessed up to 60 months.||||months||95% Confidence Interval|Median
2787643|NCT00611325|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the initiation of treatment without progression of disease. PFS was defined as the time from the initiation of treatment to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months||||percentage of participants||95% Confidence Interval|Number
2787644|NCT00611247|Secondary|Toxicity Profile: Individual Subjects With Drug-related SAEs||12 months||||participants|||Number
2787645|NCT00611247|Secondary|Toxicity Profile: Total Number of Drug-related Serious Adverse Events||12 months||||events|||Number
2787646|NCT00611247|Primary|Response Rate (CR + CRi + LFS)|"Response determined per European LeukemiaNet response criteria:~CR = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 10e9/L; platelet count > 100 x 10e9/L; and independence of red cell transfusions.~CRi = all CR criteria except for residual neutropenia (< 1.0 x 10e9/L) or thrombocytopenia (< 100 x 10e9/L)].~Morphologic leukemia-free state (LFS) = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; with no hematologic recovery required.~Relapse = bone marrow blasts >5%; reappearance of blasts in the blood; or development of extramedullary disease."|up to 2 months||||participants|||Number
2787647|NCT00611130|Post-Hoc|Medication Compliance|Using retained urine samples and prior to unblinding, up to 12 specimens/ subject were analyzed for vigabatrin levels. Compliance assessment based on > or = 70% of urines in subjects assigned to vigabatrin having quantitative levels of vigabatrin indicaticative of taking drug within the last 24 hours of clinic visit.|Week 2, 4, 6 & 9-11|Completers were defined as those who attended the scheduled Week 13 visit or the third visit of Week 12 and who also had provided urines during Weeks 11 & 12.|||participants|||Number
2787648|NCT00611130|Primary|Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.|Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.|Week 13|intent-to-treat|||participants|||Number
2787674|NCT00610857|Primary|Best Objective Response Rate (BORR)|Intention to treat response rate is estimated by the proportion of patients with a best response of CR, PR, or SD by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.0|Up to 44 months|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks|||percentage of patients||90% Confidence Interval|Number
2787649|NCT00611026|Post-Hoc|Post-hoc Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage.|Baseline up to Week 12|Safety population included all participants who were randomized and received at least 1 dose of study treatment. N=number of participants with AEs noted in other unreviewed medical chart records as performed at other departments during the clinical trial but were not included as AEs in Case Report Forms; reported post-hoc.|||events|||Number
2787650|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12|"HRQL domain and total raw score derived as sum of scores (6-point scale:~1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement."|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2787651|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2787652|NCT00611026|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.|Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||participants|||Number
2787653|NCT00611026|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||participants|||Number
2787654|NCT00611026|Secondary|Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary|Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing baseline and respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percentage of participants|||Number
2787655|NCT00611026|Secondary|Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)|Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2787656|NCT00611026|Secondary|Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||scores on a scale||Standard Error|Least Squares Mean
2787657|NCT00611026|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours|Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
2787658|NCT00611026|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours|Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||severe urgency episodes per 24 hours||Standard Error|Mean
2787659|NCT00611026|Secondary|Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
2787660|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||episodes per 24 hours||Standard Error|Least Squares Mean
2787661|NCT00611026|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours|"UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is~1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100."|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
2787662|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [LOCF] for placebo, tolterodine ER, and fesoterodine, respectively.|||episodes per 24 hours||Standard Error|Mean
2787663|NCT00611026|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
2787664|NCT00611026|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours|Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
2787665|NCT00611026|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||percent change||Full Range|Median
2787666|NCT00611026|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||micturitions per 24 hours||Standard Error|Least Squares Mean
2787667|NCT00611026|Secondary|Change From Baseline in Mean Voided Volume Per Micturition|Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (LOCF)], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.|||mL||Standard Error|Mean
2787668|NCT00611026|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 12|Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded.|||episodes per 24 hours||Standard Error|Mean
2787669|NCT00610987|Primary|Number of Participants With Total Wound Infections|The primary endpoint was infection.|at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.||||participants|||Number
2787676|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood|30 minutes post administration||||Participants|||Number
2787677|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.|30 Minutes After Application of Gemcitabine||||Participants|||Number
2787678|NCT00610727|Secondary|Dose Proportionality of Inhaled Prochlorperazine by Power Analysis|"Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|24 hours|Pharmacokinetic Population, n=40|||Slope of Power Regression||90% Confidence Interval|Geometric Least Squares Mean
2787679|NCT00610727|Secondary|Absolute Bioavailability of Inhaled Prochlorperazine|Absolute bioavailability of inhaled prochlorperazine via AUC infinity|24 hours|Bioavailability crossover subjects, n=8|||Fraction absorbed||90% Confidence Interval|Geometric Least Squares Mean
2787680|NCT00610727|Primary|Time to Peak (Tmax)|Time from dose to peak prochlorperazine concentration|24 hours|Pharmacokinetic Population|||hours||Inter-Quartile Range|Median
2787681|NCT00610714|Secondary|Overall Survival (Number of Deaths)|Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead|Date of randomization to death due to any cause||||Participants|||Number
2787682|NCT00610714|Secondary|Progression-free Survival (PFS) as Evaluated by RECIST|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.|Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)||||Months||Full Range|Median
2787683|NCT00610714|Primary|Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)|Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.|Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)||||Participants|||Number
2787684|NCT00610701|Primary|Quadriceps Strength|measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose|(admission, 6 weeks, 3 months, 6 months) 1 year||||Nm||Standard Deviation|Mean
2787685|NCT00610688|Secondary|Birthweight of Newborn Infant|Growth of the Newborn Infant as Measured by Birthweight in grams.|Measured at birth.||||Grams||Standard Deviation|Mean
2787686|NCT00610688|Secondary|Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth|Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth|At delivery||||cm||Standard Deviation|Mean
2787687|NCT00610688|Primary|Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement|Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement|29 weeks|Intention to treat analysis.|||nmol/L||Standard Error|Mean
2787688|NCT00610675|Secondary|Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52|Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Units on a scale||Standard Deviation|Mean
2787689|NCT00610675|Secondary|Change From Baseline in Quality of Sleep Scale at Week 52|Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Units on a scale||Standard Deviation|Mean
2787690|NCT00610675|Secondary|Change From Baseline in Number of Awakenings at Week 52|Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Awakenings||Standard Deviation|Mean
2787691|NCT00610675|Secondary|Change From Baseline in Wake Time After Sleep Onset at Week 52|Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Minutes||Standard Deviation|Mean
2787692|NCT00610675|Secondary|Change From Baseline in Sleep Latency at Week 52|Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Minutes||Standard Deviation|Mean
2787693|NCT00610675|Secondary|Change From Baseline in Total Sleep Time at Week 52|"Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question How much time did you actually spend sleeping?. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged."|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary|||Minutes||Standard Deviation|Mean
2787694|NCT00610675|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to 52 weeks|AST population consisting of all enrolled participants who received at least one dose of trial medication|||Participants|||Number
2787695|NCT00610675|Primary|Number of Participants With an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to 57 weeks|All subjects treated (AST) population consisting of all enrolled participants who received at least one dose of trial medication|||Participants|||Number
2787696|NCT00610649|Secondary|Part 2: Change From Baseline in the MADRS|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 28)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).|||score on a scale||Standard Deviation|Mean
2787697|NCT00610649|Secondary|Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 16)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||score on a scale||Standard Deviation|Mean
2787698|NCT00610649|Primary|Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 28 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
2787699|NCT00610649|Primary|Part 2: Number of Participants With AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 7 days following the last dose of study drug (Up to 35 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
2787700|NCT00610649|Primary|Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 16 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
2787701|NCT00610649|Primary|Part 1: Number of Participants With Serious Adverse Events (SAEs)|An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 30 days following the last dose of study drug (Up to 46 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
2787702|NCT00610649|Primary|Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.|Up to 7 days following the last dose of study drug (Up to 23 days)|The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).|||participants|||Number
2787703|NCT00610558|Primary|Functional Connectivity|We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.|During Imaging Session|This protocol has been closed about 10 years ago. All files have been destroyed per IRB requirement.||||||
2787704|NCT00610532|Primary|Quantitative EEG Recordings||end of each treatment|No data was analyzed because the study was terminated by the investigators after they decided not to continue the project||||||
2787705|NCT00610467|Primary|Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions|ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT|After we meet the enrollment target|We had performed the combined MRI and optical imaging on two subjects. Due to the small sample size, there is low statistical power to conclude any findings. Study was terminated pre-maturely. All files have been destroyed per IRB requirement. No outcome measure data are available.||||||
2787706|NCT00610441|Secondary|Computerized Cognition Assessment: Working Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of working memory (score range: -48 to 48), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for working memory.|||score on a scale||Standard Deviation|Mean
2787707|NCT00610441|Secondary|Computerized Cognition Assessment: Visual Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of visual memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for visual memory.|||score on a scale||Standard Deviation|Mean
2787708|NCT00610441|Secondary|Computerized Cognition Assessment: Verbal Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of verbal memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for verbal memory.|||score on a scale||Standard Deviation|Mean
2787709|NCT00610441|Secondary|Computerized Cognition Assessment: Sustained Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of sustained attention (score range -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for sustained attention.|||score on a scale||Standard Deviation|Mean
2787710|NCT00610441|Secondary|Computerized Cognition Assessment: Reasoning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reasoning (score range: -15 to 15), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reasoning.|||score on a scale||Standard Deviation|Mean
2787711|NCT00610441|Secondary|Computerized Cognition Assessment: Reaction Time|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reaction time (lowest time possible is 0 msec), with a lower reaction time indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reaction time.|||msec||Standard Deviation|Mean
2787712|NCT00610441|Secondary|Computerized Cognition Assessment: Speed of Processing|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of speed of processing (score range: -1000 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for speed of processing.|||score on a scale||Standard Deviation|Mean
2787713|NCT00610441|Secondary|Computerized Cognition Assessment: Executive Functioning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of executive functioning (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for executive functioning.|||score on a scale||Standard Deviation|Mean
2787714|NCT00610441|Secondary|Computerized Cognition Assessment: Composite Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of composite memory (score range: -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for composite memory.|||score on a scale||Standard Deviation|Mean
2787715|NCT00610441|Secondary|Computerized Cognition Assessment: Complex Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of complex attention (score range: 0 to 250), with a lower score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for complex attention.|||score on a scale||Standard Deviation|Mean
2787716|NCT00610441|Secondary|Computerized Cognition Assessment: Cognitive Flexibility|Cognition was assessed by a computerized cognitive testing (©CNS Vital Signs, Chapel Hill, NC) battery consisting of neuropsychological tests that measure the cognitive domain of cognitive flexibility (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for cognitive flexibility.|||score on a scale||Standard Deviation|Mean
2787717|NCT00610441|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score|The TASS is a participant-administered scale to assess study drug effects in the evening. Participants respond to 18 questions about ADHD symptoms, with scores from 0=Not at all to 3=Severe. Total scores can range from 0 to 54, with a higher score indicating more severe ADHD symtoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline TASS efficacy assessment.|||score on a scale||Standard Deviation|Mean
2787718|NCT00610441|Secondary|Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score|The QIDS-C is a clinician-administered rating scale to measure the severity of depressive symptoms within the 9 DSM-IV major depression disorder symptom (MDD) domains: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. There is one score (0=none to 3=severe) for each of the of the 9 domains. The total score is obtained by adding the scores for each of the 9 symptom domains. QIDS-C total scores can range from 0 to 27, with a higher score indicating more severe depression. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline QIDS-C efficacy assessment.|||score on a scale||Standard Deviation|Mean
2787719|NCT00610441|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score|The PSQI is a participant-rated scale to assess the quality of sleep. The PSQI consists of 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score can range from 0=better (i.e., 0 times per month) to 3=worse (i.e., 3 or more times per week). The sum of these 7 component scores yields one total score with a range of 0 (better) to 21 (worse). A total PSQI score <=5 is associated with good sleep quality; a total score >5 is associated with poor sleep quality. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline PSQI efficacy assessment.|||score on a scale||Standard Deviation|Mean
2787720|NCT00610441|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score|The ESS is an 8-item scale used to assess sleepiness. The test consists of a list of 8 situations in which participants rate their tendency to become sleepy on a scale of 0=Would never doze to 3=High chance of dozing. The scores for each of the 8 situations are added to create a total score on a scale with a range from of 0 to 24. A higher score indicates a greater degree of sleepiness. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline ESS efficacy assessment.|||score on a scale||Standard Deviation|Mean
2787721|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores|The CGI-I is a 7-point clinician-rated scale for assessing the global improvement of ADHD. Scores could range from 1=Very much improved to 4=No change to 7=Very much worse, with a lower score indicating the most improvement. Analysis of CGI-I was performed using a proportional odds model. For statistical analyses, CGI-I assessments were condensed to one assessment of improvement per treatment period by taking the worst improvement score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-I efficacy assessment.|||percentage of participants|||Number
2787722|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores|The CGI-S is a 7-point clinician-rated scale for assessing the global severity of ADHD. Scores could range from 1=Normal, not at all ill to 7=Among the most extremely ill, with a higher score indicating more severe illness. Categorization was as follows: 1=Normal, not at all ill and Borderline mentally ill; 2=Mildly ill; 3=Moderately ill and 4=Markedly ill, Severely ill and Among the most extremely ill patients, with a higher category indicating more severe illness. Analysis of CGI-S was performed using a proportional odds model. For statistical analyses, CGI-S assessments were condensed to one assessment of severity per treatment period by taking the most severe score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-S efficacy assessment.|||percentage of participants|||Number
2787723|NCT00610441|Secondary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to last dose of study drug (Up to 56 days)|The AST population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).|||percentage of participants|||Number
2787724|NCT00610441|Secondary|Percentage of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to 7 days after last dose of study drug (Up to 63 days)|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).|||percentage of participants|||Number
2787725|NCT00610441|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the DSM-IV diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.|||percentage of participants|||Number
2787726|NCT00610441|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.|||percentage of participants|||Number
2787727|NCT00610441|Primary|Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.|Baseline (BL) and Day 7, Day 14, Day 21|The Intent-to-Treat (ITT) population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline AISRS efficacy assessment. Results are reported by the study drug being administered at time of assessment and not by randomly assigned sequence.|||score on a scale||Standard Deviation|Mean
2787728|NCT00610428|Secondary|Survival Analysis for Time to Pain Relief|Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition|from treatment (time = 0) to 2 hours post treatment|ITT Population by Treatment Assigned|||minutes to pain relief||Standard Error|Mean
2787729|NCT00610428|Primary|Headache Pain Relief at 2 hr Post-dose by 2-point Definition|patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain|2 hours after treatment|ITT Population with LOCF|||Participants|||Count of Participants
2787739|NCT00610311|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells.|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.||||||
2787860|NCT00609336|Secondary|CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy|Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.|Up to 26 weeks after surgery|Biomarker data not collected.||||||
2787730|NCT00610363|Secondary|Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
2787731|NCT00610363|Secondary|Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
2787732|NCT00610363|Secondary|Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per month per participant was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
2787733|NCT00610363|Secondary|Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per participant was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
2787734|NCT00610363|Secondary|Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||number of gout flares||Standard Deviation|Mean
2787735|NCT00610363|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||percentage of participants|||Number
2787736|NCT00610363|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 (Baseline) to Day 84 (Week 12)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized).|||Number of gout flares per participant||Standard Deviation|Mean
2787737|NCT00610311|Secondary|Number of Participants Who Develop Anti-mouse T Cell Receptor (TCR) Antibodies|Blood samples are collected from the patient and an immunological test is conducted in the laboratory to determine if the patient has generated antibodies against the mouse T-cell receptor which is part of the anti-gp100 cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.||||||
2787738|NCT00610311|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18.5 months||||Participants|||Number
2788192|NCT00607672|Primary|Plasminogen Activator Inhibitor-1 (PAI-1) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the fibrinolytic responses to CPB as measured by PAI-1 response|From the start of surgery until postoperative day 2||||ng/mL||Standard Error|Mean
2787740|NCT00610311|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met||||Participants|||Number
2787741|NCT00610207|Primary|Fistula Closure (Tract Based)|"Fistula closure is defined as absence of drainage at the external fistula opening.~An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient."|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.|||tracts|Participants||Number
2787742|NCT00610207|Primary|Fistula Closure (Patient Based)|Fistula closure is defined as absence of drainage at the external fistula opening.|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.|||participants|||Number
2787743|NCT00610168|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2787744|NCT00610168|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2787745|NCT00610168|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Subjects|||Number
2787746|NCT00610168|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Subjects|||Number
2787747|NCT00610168|Secondary|Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
2787748|NCT00610168|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787749|NCT00610168|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
2787750|NCT00610168|Secondary|Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Concentrations are presented as international units per millilitre (IU/mL).|At Month 0 (PRE) and Month 1 (POST)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2787751|NCT00610168|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs|The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 1|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
2787777|NCT00609869|Secondary|Clinical Benefit Rate|The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants|||percentage of participants|||Number
2787752|NCT00610168|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs|The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.|||Subjects|||Number
2787753|NCT00610155|Secondary|Doleur Neuropathic 4 (DN4) Score|DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain.|Day -35|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
2787754|NCT00610155|Secondary|Present Pain Intensity Score (PPIS)|"Participants answered: Please rate your pain from 0-10 that best describes the intensity of pain right now. PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain)."|Day 8, 22, 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2787755|NCT00610155|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated.|Day -35 through Day 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2787756|NCT00610155|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain.|Baseline (Day -7), Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
2787757|NCT00610155|Secondary|Pain Catastrophising Scale (PCS)|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
2787758|NCT00610155|Secondary|State and Trait Anxiety Questionnaire|"Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants."|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
2787759|NCT00610155|Secondary|Beck Depression Inventory (BDI)|BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
2787760|NCT00610155|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.||||||
2787761|NCT00610155|Primary|Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions|Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG.|Day 8, 22, 36|Data was not analyzed since these methods were not technically robust enough to make any clear conclusions.||||||
2787762|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)|BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.|Day 8, 22, 36|For VIS, based on preliminary analysis results, it was not considered significant to collect data according to Investigator's opinion.||||||
2787842|NCT00609492|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within 31-days (Day 0-30) after booster vaccination|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2787763|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.|||percent signal change||Standard Error|Least Squares Mean
2787764|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.|||percent signal change||Standard Error|Least Squares Mean
2787765|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)|BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.|||percent signal change||Standard Error|Least Squares Mean
2787766|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain|BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).|Day 8, 22, 36|Data not available to report, as BOLD brain activation signals in whole brain were obtained as specific Contrast Parameter Estimates (COPE) images only, as per planned analysis.||||||
2787767|NCT00610129|Primary|Objective Response Rate (ORR)|in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.|2 years||||participants|||Number
2787768|NCT00609986|Secondary|Severe Hyperglycemia|Blood glucose greater than 350 mg/dl.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
2787769|NCT00609986|Primary|Acute/Active Rejection|Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
2787770|NCT00609986|Secondary|Severe Hypoglycemia|Blood glucose less than 40 mg/dl|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
2787771|NCT00609986|Primary|Delayed Graft Function|Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.|10 days|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.|||participants|||Number
2787772|NCT00609973|Secondary|Endoscopic Recurrence Under Postoperative Treatment With Study Medication at 6 Months||6 months|Endoscopy 6 months, Intention-to-Treat analysis, patients not undergoing endoscopy were assumed to have endoscopic recurrence|||participants|||Number
2787773|NCT00609973|Primary|Safety and Tolerability of Ciprofloxacin|Adverse events (AE) Discontinuation of study drug due to probably study drug related AE|6 Months|Intention to Treat analysis.Adverse events (AE), which were classified as probably or possibly related to the study drug.|||Adverse events|||Number
2787774|NCT00609947|Primary|Major Adverse Cardiac Events (MACE) Rate|Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.|12 months post-procedure|"12-month MACE Rate was compared to a 20% performance goal.~1st 97 subjects enrolled and implanted with 2.25mm stents~1st 39 subjects enrolled and implanted with 2.5mm stents~1st 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"|||Percentage||95% Confidence Interval|Number
2787775|NCT00609947|Primary|In-segment Percent Diameter Stenosis at 8 Months Post-procedure|In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).|8 months post-procedure|The primary analysis sample consisted of 176 subjects (ITT) including the first 97 subjects with 2.25 mm, 39 subjects with 2.50 mm and 40 subjects with 2.75mm stents who met the study entry criteria, signed the written informed consent, and were enrolled in the trial.|||percent diameter stenosis||95% Confidence Interval|Mean
2787776|NCT00609869|Secondary|Median Time to Treatment Failure (TTF)|The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants|||months||95% Confidence Interval|Median
2787778|NCT00609869|Primary|Overall Response Rate (ORR)|The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants|||percentage of participants|||Number
2787779|NCT00609804|Secondary|Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability|Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0|18 months|All patients on study|||participants|||Number
2787780|NCT00609804|Secondary|Overall Response Rate|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients on study|||participants|||Number
2787781|NCT00609804|Primary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study|||months||95% Confidence Interval|Median
2787782|NCT00609765|Secondary|The Number of Participants With Radiographic Response|Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.|2 years|||||||
2787783|NCT00609765|Primary|Number of Participants With Progression Free Survival (PFS) at 12 Months|We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).|12 months|Per protocol at 12 months||||||
2787784|NCT00609739|Secondary|Patients Who Relapsed|Number of patients whose disease relapsed.|1 Year||||participants|||Number
2787785|NCT00609739|Secondary|Patients With Graft-Versus-Host-Disease|Number of patients who exhibited acute and/or chronic graft-versus-host disease.|Up to 30 Days Post Study Treatment||||participants|||Number
2787786|NCT00609739|Secondary|Patients With Regimen-Related Toxicity|Number of patients with adverse events related to treatment.|Up to 30 Days Post Study Treatment||||participants|||Number
2787787|NCT00609739|Primary|Disease-free Survival|Number of patients who were free of disease and alive at 1 year.|1 year||||Participants|||Number
2787788|NCT00609674|Secondary|Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])|RQLQ(S) is a 28-item, self-administered, disease-specific (allergic rhinitis), quality of life instrument that assesses quality of life over a 1-week interval. Each question is scored from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment on quality of life. RQLQ(S): Possible score ranges from 0 to 6. Change from baseline is calculated as the score at the endpoint minus the score at baseline.|Baseline and Week 4|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787789|NCT00609674|Secondary|Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF|PNIF: Objective measure of nasal airway flow obstruction.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Liters/minute||Standard Error|Least Squares Mean
2787790|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)||||Points on a scale||Standard Error|Least Squares Mean
2787791|NCT00609674|Secondary|Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787792|NCT00609674|Secondary|Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). AM, pre-dose iTOSS: sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||percent change||Standard Error|Least Squares Mean
2787855|NCT00609362|Secondary|Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.|Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)|Measured at baseline and after 14 weeks of treatment||||Percent change in LWR||Standard Deviation|Mean
2787793|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787794|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787795|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787796|NCT00609674|Secondary|Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787797|NCT00609674|Secondary|Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||percent change||Standard Error|Least Squares Mean
2787798|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787799|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS|TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787800|NCT00609674|Primary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|Intent-to-Treat (ITT) Population: all randomized subjects who received at least one dose of study drug|||Points on a scale||Standard Error|Least Squares Mean
2787801|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)|The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787802|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)|The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population|||Points on a scale||Standard Error|Least Squares Mean
2787856|NCT00609362|Primary|Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group|Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)|BMD measured at baseline and after 14 weeks of treatment||||Percent change from baseline||Standard Deviation|Mean
2787803|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score|FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.|Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2787804|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score|FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.|Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)|FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here “n” signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||Units on a scale||Standard Deviation|Mean
2787805|NCT00609622|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|Data was not analyzed due to early study termination.||||||
2787806|NCT00609622|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2787807|NCT00609622|Secondary|Two Year Survival Probability|Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)|Data was not analyzed due to early study termination.||||||
2787808|NCT00609622|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)|Data was not analyzed due to early study termination.||||||
2787809|NCT00609622|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
2787810|NCT00609622|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
2787811|NCT00609609|Post-Hoc|Non-relapse Mortality (NRM) at 6 Months|Percentage of participants at 6 months whose deaths were without relapse/recurrence.|6 months||||percentage of participants||95% Confidence Interval|Number
2787812|NCT00609609|Post-Hoc|Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56|Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56.|Up to day 56||||percentage of participants|||Number
2787857|NCT00609336|Secondary|Percent of Patients Surviving at Annual Intervals||5 years||||percentage of participants|||Number
2787813|NCT00609609|Primary|Day 56 Treatment Success|Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status.|Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.||||percentage of participants|||Number
2787814|NCT00609518|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)|||months||95% Confidence Interval|Median
2787815|NCT00609518|Secondary|Overall Survival|Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)|||months||95% Confidence Interval|Median
2787816|NCT00609518|Secondary|Proportion of Participants With Best Overall Tumor Response (Response Rate)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.|Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.|Qualified Intent to Treat (Q-ITT)|||proportion of patients||95% Confidence Interval|Mean
2787817|NCT00609518|Primary|Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity|"Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows:~Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section."|From first dose of treatment to last dose of treatment plus 30 days|Qualified Intention to Treat (Q-ITT)|||participants|||Number
2787818|NCT00609492|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2787819|NCT00609492|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787820|NCT00609492|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2787821|NCT00609492|Secondary|Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes|A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787822|NCT00609492|Secondary|Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)|Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
2787858|NCT00609336|Secondary|Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 26 weeks after surgery (the end of adjuvant chemotherapy)|All eligible patients|||occurrence of toxicities|||Number
2787823|NCT00609492|Secondary|Antibody Titers Against Anti-polio Type 1, 2 and 3|Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2787824|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)|A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787825|NCT00609492|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations < 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.|One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787826|NCT00609492|Secondary|Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787827|NCT00609492|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787828|NCT00609492|Secondary|Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)|Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2787829|NCT00609492|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL|The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787830|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787831|NCT00609492|Secondary|Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)|Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2787832|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)|A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787833|NCT00609492|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2787834|NCT00609492|Secondary|Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)|A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787835|NCT00609492|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2787836|NCT00609492|Secondary|Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A|A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787837|NCT00609492|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2787838|NCT00609492|Secondary|Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes|A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787839|NCT00609492|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Serotypes|A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).|Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2787840|NCT00609492|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2787841|NCT00609492|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the active phase of the study (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2787843|NCT00609492|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|"Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Subjects|||Number
2787844|NCT00609492|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Subjects|||Number
2787845|NCT00609492|Primary|Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.|Within 4-days (Day 0-3) after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Subjects|||Number
2787846|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain)."|Baseline to 72 hours after first intake of study drug|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
2787847|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain)."|Baseline to 24 hours after first study drug intake|Intention to treat (ITT)and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
2787848|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain)."|Baseline to 12 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
2787849|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain)."|Baseline to 6 hours after intake of first study drug|Intention to treat(ITT) and Last Observation Carried Forward (LOCF).|||units||Standard Deviation|Mean
2787850|NCT00609466|Secondary|Total Pain Relief (TOTPAR)|Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.|Baseline to 48 hours after first study drug intake|Intention to treat(ITT)and Last Observation Carried Forward (LOCF)|||units||Standard Deviation|Mean
2787851|NCT00609466|Secondary|Number of Participants Using Rescue Medication|Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.|Baseline up to 72 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF)|||participants|||Number
2787852|NCT00609466|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain)."|Baseline value to 48 hours after first study drug intake.|Intention to Treat - randomized subjects who were dosed and had a baseline pain intensity assessment. Last observation carried forward was used.|||units||Standard Deviation|Mean
2787853|NCT00609362|Secondary|Change in Gene Expression in Bone Marrow and Fat Cells||Before and after treatment|||||||
2787854|NCT00609362|Secondary|Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups|C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).|At baseline and after 14 weeks of treatment||||Percent change from baseline||Standard Deviation|Mean
2787861|NCT00609336|Secondary|Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy|The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90|Up to 7 years|all eligible patients with non-missing data|||Participants|||Count of Participants
2787862|NCT00609336|Secondary|Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy|Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Up to 7 years|Clinical response not collected.||||||
2787863|NCT00609336|Secondary|Median Recurrence Free Survival Following Pancreaticoduodenectomy|The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.|From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years|Among eligible patients who received surgery|||months||95% Confidence Interval|Median
2787864|NCT00609336|Secondary|Percent of Patients Surviving at 5 Years|Kaplan-Meier estimate of overall survival at 5 years|Up to 5 years|all eligible patients|||percentage of eligible pts alive|||Number
2787865|NCT00609336|Primary|Median Overall Survival of Patients With Adenocarcinoma of the Pancreas|Time at which Kaplan-Meier estimate of overall survival drops below 50%|5 years|All eligible patients|||months||95% Confidence Interval|Median
2787866|NCT00609271|Primary|Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group|Mean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 Months||||% risk of developing CVD in next 10 yrs||95% Confidence Interval|Mean
2787867|NCT00609271|Primary|Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group|Mean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 Months||||µmol/L¶||95% Confidence Interval|Mean
2787868|NCT00609271|Primary|Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group|Mean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values|12 Months||||nmol/L||95% Confidence Interval|Mean
2787869|NCT00609271|Primary|Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group|Mean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||pmol/L||95% Confidence Interval|Mean
2787870|NCT00609271|Primary|Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group|Mean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||"mmol/L||"||95% Confidence Interval|Mean
2787871|NCT00609271|Primary|Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group|Mean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values|12 Months||||mm Hg||95% Confidence Interval|Mean
2787872|NCT00609271|Primary|Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mm Hg||95% Confidence Interval|Mean
2787873|NCT00609271|Primary|Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
2787874|NCT00609271|Primary|Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||ratio||95% Confidence Interval|Mean
2787875|NCT00609271|Primary|Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
2787876|NCT00609271|Primary|Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
2787877|NCT00609271|Primary|Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||mmol/L||95% Confidence Interval|Mean
2787878|NCT00609271|Primary|Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group|Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||cm||95% Confidence Interval|Mean
2787879|NCT00609271|Primary|Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group|Mean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||% body weight that is fat mass||95% Confidence Interval|Mean
2787880|NCT00609271|Primary|Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group|Mean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||% of body weight that is lean mass||95% Confidence Interval|Mean
2787881|NCT00609271|Primary|Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group|Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.|12 months||||kg||95% Confidence Interval|Mean
2787882|NCT00609245|Primary|Difference in SPR During Placebo and VPA Infusions|"standard photosensitive range (SPR) Each participant is exposed to intermittent photic stimulation at 14 predetermined frequencies in order to detect changes in response around typical upper and lower frequency thresholds (e.g., 2 Hz, 5 Hz, 8Hz, 10 Hz, etc.). Each flash frequency that elicits a photosensitive response is considered one step, and the result is transformed into a metric called the standardized photosensitive range (SPR). The SPR ranges from 0 to 14, where each point represents the number of flash frequencies that elicited a photosensitive response."|At the start of EEG monitoring/drug infusion, and on an hourly basisfor 12 hours|1 patient did not complete infusion of Valproic Acid due to Adverse Event. This patient was not included in final analysis.|||standard photosensitive range (SPR)||Full Range|Mean
2787883|NCT00609167|Secondary|Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant|Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.|After 4 cycles of treatment|At the time of publication, data was available on 18 patients for group 2.|||participants|||Number
2787884|NCT00609167|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 12 cycles)||||participants|||Number
2787885|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles|"Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 12 cycles of treatment|No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.|||participants|||Number
2787886|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 8 cycles of treatment|Participants who received 8 cycles of treatment were analyzed.|||participants|||Number
2787887|NCT00609167|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.|Duration of study (up to 12 cycles)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.|||months||95% Confidence Interval|Median
2787888|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.~CR, nCR and VGPR as defined in the primary outcome.~Partial Response(PR): >=50% reduction in serum M-component and/or~Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 cycles|Participants who received 4 cycles of treatment were analyzed.|||participants|||Number
2787889|NCT00609167|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|From date of registration until death (up to 5 years)||||months||95% Confidence Interval|Median
2787890|NCT00609167|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|up to 5 years||||months||95% Confidence Interval|Median
2787891|NCT00609167|Primary|Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow."|After 4 months of treatment||||participants|||Number
2787892|NCT00609128|Primary|Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion|"Outcome:~The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay.~Eosinophils in eosinophils / square cm measured."|1 week for tear collection, tears stored at - 80 C until used||||eosinophils/square cm epithelial cells||Standard Error|Mean
2787893|NCT00608985|Secondary|Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)|sLSO was the self-reported time to fall asleep as reported in the sleep diary|From baseline to Week 1&2|All treated patients with available data|||minutes||95% Confidence Interval|Median
2787894|NCT00608985|Secondary|Change From Baseline to Day 15&16 in LPS|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 15&16|All treated patients|||minutes||95% Confidence Interval|Median
2787895|NCT00608985|Secondary|Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 1&2|All treated patients|||minutes||95% Confidence Interval|Median
2787896|NCT00608985|Primary|Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)|sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2|From baseline to Week 1&2|All treated patients with available data|||minutes||95% Confidence Interval|Median
2787897|NCT00608985|Primary|Change From Baseline to Day 15&16 in WASO|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.~For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 15&16|All treated patients|||minutes||95% Confidence Interval|Median
2787898|NCT00608985|Primary|Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.~For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 1&2|All treated patients|||minutes||95% Confidence Interval|Median
2787899|NCT00608959|Primary|Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)|Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion.|Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.|intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days.|||participants|||Number
2787900|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days|Change in the mean number of skin bacterial counts (log 10 CFU/cm2)which was calculated by subtracting log10 CFU/cm2 at 7 days (one sample per site per subject per timepoint) from log10CFU/cm2 at 0 hours in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 7 days post application.|In Part 2 of the study 25 subjects had only omiganan applied to sites across the upper chest or abdomen.Swab cultures were obtained over a period of 7 days at protocol-specified times|||log 10 CFU/sq. cm||Standard Deviation|Mean
2787901|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours|Change in the mean number of skin bacterial counts (CFU/cm2) which was calculated by subtracting log10 CFU/cm2 at 72 hours (single sample per subject per timepoint) from the log10 CFU/cm2 at 0 hours (baseline) in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 72 hours post application|ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours.|||log 10 CFU/cm sq||Standard Deviation|Mean
2787902|NCT00608907|Primary|Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours||Cycle 3 day 14 (72 hours post last dose)|Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study.|||ng*h/mL||Standard Deviation|Mean
2787903|NCT00608894|Secondary|Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months|Percents of patients in each treatment group classified as having an incomplete response (defined as some or no improvement during therapy), a treatment failure (defined as permanent discontinuation of the regimen originally randomized to), or a case of relapse (recurrence following achievement of remission)|6 months||||Participants|||Count of Participants
2787904|NCT00608894|Secondary|Biochemical Remission by Month 3.|Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.|3 months||||Participants|||Count of Participants
2787905|NCT00608894|Primary|Biochemical Remission of (AIH) at Month 6.|Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.|6 months||||Participants|||Count of Participants
2787906|NCT00608881|Secondary|Number Completing Study at Assigned Dosage Level||5 years||||participants completing study on drug|||Number
2787907|NCT00608881|Secondary|Time to a Three-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years||||days to event||95% Confidence Interval|Median
2787908|NCT00608881|Secondary|Time to a Two-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years||||days to event||95% Confidence Interval|Median
2787909|NCT00608881|Secondary|Change in Stroop Interference Test - Interference From Baseline to Month 60|Stroop Interference Test - interference score is the total number of correct items identified in 45 seconds and reflects an executive measure of inhibitory ability.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787910|NCT00608881|Secondary|Change in Stroop Interference Test - Word Reading From Baseline to Month 60|Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787911|NCT00608881|Secondary|Change in Stroop Interference Test - Color Naming From Baseline to Month 60|Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787912|NCT00608881|Secondary|Change in Verbal Fluency Test From Baseline to Month 60|The verbal fluency test is typically considered a measure of executive function. The score is the number of correct words produced across three 1-minute trials.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787913|NCT00608881|Secondary|Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60|The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787914|NCT00608881|Secondary|Change in Behavioral Frequency x Severity Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. The total score is the sum of the product of the individual behavioral frequency and severity items (range 0-176) with higher scores representing more severe behavioral impairment.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787915|NCT00608881|Secondary|Change in Behavioral Frequency Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. A total score was calculated by summing up all the individual behavioral frequency items (range 0-56) with higher scores representing more severe behavioral impairment.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787916|NCT00608881|Secondary|Change in Total Motor Score From Baseline to Month 60|The motor section of the Unified Huntington's Disease Rating Scale (UHDRS) assesses motor features of Huntington disease with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor score is the sum of all the individual motor ratings, with higher scores (124) indicating more severe motor impairment than lower scores. The score ranges from 0 to 124.|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787917|NCT00608881|Secondary|Change in Independence Scale Score From Baseline to Month 60|The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.|Baseline and Month 60||||units on a scale||Standard Error|Mean
2787918|NCT00608881|Secondary|Change in Functional Checklist Score From Baseline to Month 60|"The functional assessment checklist includes 25 questions about common daily tasks. A score of 1 is given for each yes reply and a score of 0 is given for each no reply (scale range is 0-25). Higher scores indicate better functioning."|Baseline and Month 60||||units on a scale||Standard Error|Mean
2787919|NCT00608881|Secondary|Change in Total Functional Capacity (TFC) Score From Baseline to Month 60|TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|Baseline and Month 60||||units on a scale||Standard Error|Least Squares Mean
2787920|NCT00608881|Primary|Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))|The primary outcome variable at the start of the trial was the change in TFC score from baseline to Month 60. The Data and Safety Monitoring Board recommended to the trial leadership that they reconsider how they accommodate missing data from subjects who die in their primary analysis of the change in TFC score. Based on these recommendations, the trial leadership changed the primary analysis to that of a joint rank approach. TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years||||rank||Standard Deviation|Mean
2787921|NCT00608868|Secondary|Adverse Event|An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||participants|||Number
2787922|NCT00608868|Secondary|Overall Survival||Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.|||||||
2787923|NCT00608868|Secondary|Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)|"Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28.~The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.~The percentage of patients who showed improvement is reported."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||percentage of participants|||Number
2787924|NCT00608868|Secondary|Period of Progression-Free Survival|The median months without event of progression disease according to RECIST criteria is analysed.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||months||95% Confidence Interval|Median
2787925|NCT00608868|Primary|Objective Response Rate(ORR)|"Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated.~According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)||||Percent of participants|||Number
2787926|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Week 20|After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.|Week 20|Safety population with biopsy results at week 20|||participants|||Number
2787927|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Screening|A needle core tissue sample biopsy was performed at screening for all treated lipomas.|Screening (prior to randomization)|Safety population with biopsy results at screening|||participants|||Number
2787928|NCT00608842|Primary|Number of Participants With Clinically Significant Changes in Vital Signs or Weight||Up to 24 weeks|Safety population|||participants|||Number
2788550|NCT00604890|Primary|Number of Participants With Complete Response|To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment).|10 weeks||||Participants|||Count of Participants
2787929|NCT00608842|Secondary|Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas|Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size.|Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)|MITT Population|||percent change||Standard Deviation|Mean
2787930|NCT00608842|Primary|Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities|An abnormality is defined as a value outside the limits of the expanded normal range/notable range.|24 weeks|Safety population|||participants|||Number
2787931|NCT00608842|Secondary|Percentage of Participants With Complete Clearance or ≥ 75% Clearance|"At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers.~Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s).~For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response."|Baseline and week 20 (8 weeks after last dose)|MITT Population|||percentage of participants|||Number
2787932|NCT00608842|Primary|Number of Participants With Adverse Events (AEs)|"Severity of AEs was determined using the following scale:~Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: Was there a reasonable possibility that the event may have been caused by treatment with study material? A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard."|Up to 24 weeks|Safety population (all participants who received at least 1 dose of study medication)|||participants|||Number
2787933|NCT00608829|Primary|Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment|Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).|one year||||Participants|||Number
2787934|NCT00608777|Primary|The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2||week 2|||||||
2787935|NCT00608634|Secondary|Skin Related Events From Perillyl Alcohol at Administered Doses by Participants|The events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI)|3 months||||participants|||Number
2787936|NCT00608634|Primary|Change in Histopathology Score of Sun Damaged Skin by Treatment Group|The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 & 2), 2- inflammation (grades 0, 1 & 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were >3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of >3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.|Baseline to 3 months|change in histopathological scoring was calculated only for participants with baseline and end of study measurements. (n=79)|||units on a scale||Standard Deviation|Mean
2787937|NCT00608582|Primary|Phrase Length|Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS|||number of words per phrase length||Standard Deviation|Mean
2787938|NCT00608582|Primary|Picture Naming|Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series|||number of pictures||Standard Deviation|Mean
2787939|NCT00608569|Secondary|Adherence to Second Line HAART Regimen|Number of participants with self-reported 100% adherence over the week prior to study visit|At weeks 4, 8, 12, 24, 36, 48 and 52|Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected.|||participants|||Number
2787940|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab or Sign/Symptom Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.|||weeks||95% Confidence Interval|Number
2787941|NCT00608569|Secondary|Time to First Grade 3 or 4 Sign or Symptom|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.|||weeks||95% Confidence Interval|Number
2787942|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.|||weeks||95% Confidence Interval|Number
2787943|NCT00608569|Secondary|CD8 Count at Follow-up Visits|CD8 cell count (median, inter-quartile range)|At week 4, 12, 24, 36, and 48||||cells/mm3||Inter-Quartile Range|Median
2787944|NCT00608569|Secondary|CD4 Count at Follow-up Visits|CD4 cell count (median, inter-quartile range)|At Weeks 4, 12, 24, 36, and 48||||cells/mm3||Inter-Quartile Range|Median
2787955|NCT00608530|Secondary|Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study|"The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from 0 to 1 0 where 0 indicates no pain and 10 indicates the worst imaginable pain."|Baseline, End of Treatment of Nurse-Delivered Treatment Study (8 weeks)|Modified intent-to-treat analysis of all randomized participants who attended 1 or more treatment visits; multiple imputation used to address missing data.|||units on a scale||Standard Deviation|Mean
2787945|NCT00608569|Secondary|Confirmed Virologic Failure at or Prior to Week 24|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.|At or prior to Week 24|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.|||participants|||Number
2787946|NCT00608569|Primary|Confirmed Virologic Failure at or Prior to Week 48|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.|At or prior to Week 48|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.|||participants|||Number
2787947|NCT00608543|Primary|Spatial Working Memory (SWM) Strategy Score|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention|||units on a scale||Standard Deviation|Mean
2787948|NCT00608543|Primary|Spatial Working Memory (SWM) Between Errors for 6-move Problems|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers because data were collected pre- and post-treatment|||number of errors||Standard Deviation|Mean
2787949|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention|||milliseconds||Standard Deviation|Mean
2787950|NCT00608543|Secondary|Change in Hamilton Rating Scale for Depression (HRSD - 17-item)|The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.|6 weeks|Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention|||units on a scale||Standard Deviation|Mean
2787951|NCT00608543|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire|The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.|6 weeks|Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention|||units on a scale||Standard Deviation|Mean
2787952|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention|||milliseconds||Standard Deviation|Mean
2787953|NCT00608530|Secondary|Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved'|Participant self-rating of overall change compared to baseline, considering overall function and pain intensity, using a 7-point scale ranging from 'Very Much Worse' to 'Very Much Improved.' We compared the proportion of participants in each Group rating themselves as either 'Much Improved' or 'Very Much Improved.'|End of Treatment (8 weeks)|Modified intent-to-treat analysis of all participants who attended at least 1 treatment session|||percentage of participants|||Number
2787954|NCT00608530|Secondary|Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function|"Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as Better, Worse, or About the Same. Participants then were asked to estimate the percentage of change (i.e., 0 to 100%). Participants rating themselves as About the Same were coded as 0% change. The percentage of change was calculated for each Group as a whole (Cognitive Behavioral Therapy-Psychologist Delivered compared to Supportive Care Psychologist-Delivered)."|End of Treatment (8 weeks)|Intent-to-treat analysis of all randomized participants; multiple imputation was used to address missing data.|||percent change||Standard Deviation|Mean
2787956|NCT00608530|Secondary|Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study|"The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from 0 to 1 0 where 0 indicates no pain and 10 indicates the worst imaginable pain."|Baseline, End of Treatment (8 weeks)|Intent-to-treat analysis of all randomized participants, using multiple imputation to address missing data.|||units on a scale||Standard Deviation|Mean
2787957|NCT00608530|Primary|Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study|"The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase because of my back pain (e.g., Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability."|Baseline, End of Treatment for Nurse-Delivered Treatment Study (8 weeks)|All randomized participants who attended at least 1 treatment session were analyzed, with multiple imputation used to address missing data.|||units on a scale||Standard Deviation|Mean
2787958|NCT00608530|Primary|Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study|"The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase because of my back pain (e.g., Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability."|Baseline, End of Treatment (8 weeks)|Per protocol population. All participants with baseline and Week 8 disability scores.|||units on a scale||Standard Deviation|Mean
2787959|NCT00608517|Secondary|Number of Participants With Chronic Graft Versus Host Disease (GVHD)|As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement|100 days||||participants|||Number
2787960|NCT00608517|Secondary|Overall Survival|Overall survival at 1 year|1 year||||participants|||Number
2787961|NCT00608517|Secondary|Number of Subjects With All-cause Mortality|Death from any cause at 100 days|at 100 days||||participants|||Number
2787962|NCT00608517|Secondary|Number of Participants Who Relapsed at 1 Year||1 year||||participants|||Number
2787963|NCT00608517|Secondary|Number of Participants With Acute Graft-versus-host Disease (GVHD)|Participants who exhibit acute GVHD.|100 days||||participants|||Number
2787964|NCT00608517|Secondary|Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells|Recovery of the neutrophil portion of white blood cells and showing complete donor cells.|42 days|Patients who received treatment and who did not die before day 42.|||participants|||Number
2787965|NCT00608517|Primary|Number of Participants With 100-day Non-relapse Mortality|Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).|100 days||||participants|||Number
2787966|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2787967|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2787968|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787969|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2787970|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787971|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787972|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL/hr||Standard Deviation|Mean
2787973|NCT00608491|Secondary|Change in Blood N Terminal Pro - B Natriuretic Peptides||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787974|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2787975|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2787976|NCT00608491|Secondary|Best Available Glomerular Filtration Rate Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
2787977|NCT00608491|Secondary|Best Available Serum Creatinine Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2787978|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
2787979|NCT00608491|Secondary|Weight Change||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2787982|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
2787983|NCT00608491|Secondary|Weight Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2787984|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2787985|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2787986|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787987|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2787988|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787989|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787990|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL/hr||Standard Deviation|Mean
2787991|NCT00608491|Secondary|Change in Blood N Terminal Pro-Natriuretic Peptide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787992|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2787993|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2787994|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2787995|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2787996|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787997|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
2787998|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2787999|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2788000|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL/hr||Standard Deviation|Mean
2788001|NCT00608491|Secondary|Change in Blood N- Terminal Pro- BNP||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
2788002|NCT00608491|Secondary|Change in Uric Acid||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2788003|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
2788004|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||g/dL||Standard Deviation|Mean
2788005|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
2788006|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2788007|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
2788008|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
2788009|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||g/dL||Standard Deviation|Mean
2788010|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mEq/L||Standard Deviation|Mean
2788011|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2788014|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
2788015|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled best you have ever felt and the bottom labeled worst you have ever felt."|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2788016|NCT00608491|Secondary|Change in Dyspnea Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better"|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2788017|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled best you have ever felt and the bottom labeled worst you have ever felt."|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2788018|NCT00608491|Secondary|Dyspnea Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better"|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
2788019|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788020|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788021|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788022|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788023|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788024|NCT00608491|Primary|Change in Weight||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2788025|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788026|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
2788027|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2788028|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2788029|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2788030|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2788031|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||lbs||Standard Deviation|Mean
2788032|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
2788033|NCT00608491|Secondary|Change in Serum Creatinine||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2788034|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min||Standard Deviation|Mean
2788035|NCT00608491|Primary|Change in Serum Creatinine||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
2788036|NCT00608465|Primary|This Study Will Analyze Patients' Genetic Make up to Identify Who May be at Greater Risk for Heart Disease and Strokes in Relationship to High Blood Pressure and Central Obesity.||10-weeks|Enrollment was never completed so study was never unblinded and data was never analyzed||||||
2788037|NCT00608465|Primary|Secreted Factors From Adipocytes Have Autocrine, Paracrine and Endocrine Effects That Have a Deleterious Effect on the Fibrinolytic System, Either by Enhancing PAI-1 Production or Impairing Endothelial t-PA Release||10-Week period|Enrollment was never completed so study was never unblinded and data was never analyzed||||||
2788038|NCT00608426|Secondary|7-day Point Prevalence Abstinence||12 months after randomizatoin|Out of the 3382 completed follow-up surveys, 3056 completed the 7-day point prevalence outcome.|||percentage of participants|||Number
2788039|NCT00608426|Secondary|Treatment Utilization Rates for Counseling and/or Pharmacotherapy||12 months after randomization||||percentage of participants|||Number
2788040|NCT00608426|Primary|Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence||12 months after randomization|Out of the 3382 completed follow-up surveys, 3307 completed the primary smoking-abstinence outcome.|||percentage of participants|||Number
2788041|NCT00608322|Secondary|Lactate Clearance (Blood)||0-2 hours of study drug administration|||||||
2788045|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24) on Day 21.|"Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).~The following time points were used to obtain the PK curve for LCP-Tacro on day 21: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20 and 24 hours post-dose."|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.~The arithmetic mean and standard deviation is given."|||ng*hr/mL||Standard Deviation|Mean
2788046|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
2788047|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|"Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.~The following time points were used to obtain the PK curve for Prograf on day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 16, 20 and 24 hours after the morning dose."|7 Days|The arithmetic mean and standard deviation is given.|||ng*hr/mL||Standard Deviation|Mean
2788048|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 Days|The arithmetic mean and standard deviation is given.|||ng/mL||Standard Deviation|Mean
2788049|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788050|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788051|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788052|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788053|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788054|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788055|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788056|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788057|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788058|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788059|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788138|NCT00607893|Secondary|Augmentation Index, Morning|Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment||||percent change||95% Confidence Interval|Least Squares Mean
2788060|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788061|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788062|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788063|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788064|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788065|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788066|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788067|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788068|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788069|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788070|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788071|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788072|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788073|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788074|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788075|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788076|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788077|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788078|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788079|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788080|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).~N (number of patients analyzed) is based on number of patients who completed the question."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2788081|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
2788082|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
2788083|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
2788084|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.|||participants|||Number
2788085|NCT00608205|Secondary|Disease Recurrence|Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.|2 years after start of study|Patients that had a complete response after 12 weeks of therapy|||participants|||Number
2788086|NCT00608205|Secondary|Number of Patients With a Pathological(Final)Complete Response|A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.|at 12 weeks after completing chemoradiotherapy and surgery||||participants|||Number
2788087|NCT00608205|Secondary|Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor|Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.|at 12 weeks after completing chemoradiotherapy|intention to treat (ITT)|||participants|||Number
2788088|NCT00608205|Secondary|Overall Survival|Number of patients still alive from 2 years from start of study|2 yrs from start of study|intention to treat (ITT)|||participants|||Number
2788089|NCT00608205|Secondary|Patterns of Failure|Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.|2 years from start of study|intention to treat (ITT)|||participants|||Number
2788090|NCT00608205|Primary|Relapse Free Survival|Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..|at 2 yrs from start of study|intention to treat (ITT)|||participants|||Number
2788091|NCT00608140|Secondary|Perioperative Mortality||Measured between Days 0 and 30 postsurgery||||participants|||Number
2788092|NCT00608140|Secondary|Total Mortality (All Causes)|Total all-cause mortality at 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.|Measured at Month 18|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
2788185|NCT00607672|Secondary|Stroke|New onset neurological deficit with a duration of longer than 24 hours|From arrival in intensive care unit until discharge from hospital||||percentage of patients|||Number
2788093|NCT00608140|Secondary|Total Days Alive and Total Days Not Hospitalized|Total days alive and not hospitalized by 18 months. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.|Measured at baseline and Month 18|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
2788094|NCT00608140|Secondary|Change in Minnesota Living With Heart Failure (MLHF) Score|Change in MLHF score. However, the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No analysis was performed.|Planned to be measured at baseline and Month 18 but n/a|the 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
2788095|NCT00608140|Secondary|Change in 6-minute Walk Test|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.|Measured at baseline and Month 18 but n/a|The 2 patients enrolled did not meet the 18 month measurement of primary/secondary endpoints before the trial was terminated. No data were collected for this outcome measure and no analysis was performed.||||||
2788096|NCT00608140|Secondary|Peak VO2||Measured at Month 18|The 2 patients enrolled in the study did not reach their endpoints before the trial was closed. No data were collected for this outcome measure and no analysis was performed.||||||
2788097|NCT00608140|Primary|Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)||Measured at Month 18|Data were not analyzed due to study termination||||||
2788098|NCT00608023|Primary|Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52|Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.|Baseline and Week 52||||mg/dL||Standard Deviation|Mean
2788099|NCT00608023|Primary|Changes From Baseline in Fasting Blood Glucose at Week 52|Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.|Baseline and Week 52||||mg/dL||Standard Deviation|Mean
2788100|NCT00608023|Other Pre-specified|Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52|Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.|Baseline and Week 52||||ratio||Standard Deviation|Mean
2788101|NCT00608023|Other Pre-specified|Changes From Baseline in Triglycerides at Week 52|Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.|Baseline and Week 52||||mg/dL||Standard Deviation|Mean
2788102|NCT00608023|Secondary|Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52|Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.|Baseline and Week 52|All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug).|||cm^2||Standard Deviation|Mean
2788103|NCT00607997|Secondary|Pharmacokinetics Day 4 - Vss (L)|"Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data for Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.|||L||Standard Deviation|Mean
2788104|NCT00607997|Secondary|Pharmacokinetics Day 4 - CL (L/hr)|"Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.|||L/hr||Standard Deviation|Mean
2788105|NCT00607997|Secondary|Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)|"Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data, for 5 patients in Schedule C, and for 7 patients in Schedule C.|||hr||Standard Deviation|Mean
2788106|NCT00607997|Secondary|Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)|"Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 8 patients in Schedule C.|||hr*ng/mL||Standard Deviation|Mean
2788128|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788107|NCT00607997|Secondary|Pharmacokinetics Day 1 - Vss (L)|"Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||L||Standard Deviation|Mean
2788108|NCT00607997|Secondary|Pharmacokinetics Day 1 - CL (L/hr)|"Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||L/hr||Standard Deviation|Mean
2788109|NCT00607997|Secondary|Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)|"Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||hr||Standard Deviation|Mean
2788110|NCT00607997|Secondary|Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)|"Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||hr*ng/mL||Standard Deviation|Mean
2788111|NCT00607997|Secondary|All Cause Mortality|Mortality of those patients enrolled in the study and receiving intervention|30 and 60 days|All treated analysis set|||Participants|||Count of Participants
2788112|NCT00607997|Secondary|Pharmacokinetics Day 4 Cmax (ng/mL)|"Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4~Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table."|Day 4|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4 for 5 patients in Schedule C, and for 8 patients in Schedule C .|||ng/mL||Standard Deviation|Mean
2788113|NCT00607997|Secondary|Pharmacokinetics Day 1 - Cmax (ng/mL)|"Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1~Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table."|1 Day|Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.|||ng/mL||Standard Deviation|Mean
2788114|NCT00607997|Secondary|Overall Survival||2 years|All treated patients|||Months||95% Confidence Interval|Median
2788115|NCT00607997|Secondary|Leukemia-free Survival (LFS)|The censor date was the last known alive date without report of relapse.|2 years|All treated analysis set|||Months||95% Confidence Interval|Median
2788116|NCT00607997|Primary|Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions|"Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set.~Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse."|2 years|The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.|||percentage of patients||95% Confidence Interval|Number
2788117|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788118|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788119|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788120|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788121|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788122|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788123|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788124|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788125|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units||Standard Deviation|Mean
2788126|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint|The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788127|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2790106|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2788129|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788130|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788131|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788132|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788133|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788134|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788135|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788136|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2788137|NCT00607919|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2788139|NCT00607893|Secondary|Augmentation Index, Evening|Pulse wave analysis outcome (a ratio of the augmentation of central aortic pressure by a reflected pulse wave, calculated from the blood pressure waveform), analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment||||percent change||95% Confidence Interval|Least Squares Mean
2788140|NCT00607893|Secondary|Pulse Wave Velocity, Morning|Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between Months 2 and 3 of treatment||||cm/s||95% Confidence Interval|Least Squares Mean
2788141|NCT00607893|Secondary|sIL-6R|Measures of inflammation outcome, logarithm transformed before analysis due to skewed distribution, analyzed change of from baseline with adjustment of baseline. The least squares mean is transformed back to present the percent change from baseline.|Measured between baseline and after treatment||||percent change||95% Confidence Interval|Least Squares Mean
2788142|NCT00607893|Secondary|Mean Arterial BP, Morning|Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||mm Hg||95% Confidence Interval|Least Squares Mean
2788143|NCT00607893|Secondary|IL-6|Measures of inflammation outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||pg/mL||95% Confidence Interval|Least Squares Mean
2788144|NCT00607893|Secondary|Pulse Wave Velocity, Evening|Pulse wave analysis outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||cm/s||95% Confidence Interval|Least Squares Mean
2788145|NCT00607893|Secondary|Mean Arterial BP, Evening|Blood pressure outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||mm Hg||95% Confidence Interval|Least Squares Mean
2788146|NCT00607893|Primary|Myeloperoxidase|Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||pmol/L||95% Confidence Interval|Least Squares Mean
2788147|NCT00607893|Primary|F2-isoprostanes/Cr|Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline|Measured between baseline and after treatment||||ng/mg||95% Confidence Interval|Least Squares Mean
2788148|NCT00607880|Secondary|Termination of Use of the Indwelling Port at 12 Months After Port Insertion|The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.|Up to 12 months after port insertion||||participants|||Number
2788149|NCT00607880|Secondary|Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion|We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.|Up to 12 months after port insertion|All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion..|||participants|||Number
2788150|NCT00607880|Secondary|Death From All Causes|Number of patients that died during treatment due to any cause.|Up to 12 months after port insertion||||participants|||Number
2788151|NCT00607880|Primary|Port Failure Within 12 Months of Port Insertion|We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.|Up to 12 months from port insertion|Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2788152|NCT00607867|Secondary|Change in Fasting Triglycerides at 5 Weeks From Baseline|Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention||||mg/dl||Standard Error|Mean
2788153|NCT00607867|Primary|Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline|Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention||||mg/dl||Standard Error|Mean
2788154|NCT00607867|Primary|Change in Body Weight at 5 Weeks From Baseline|Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention||||pounds||Standard Error|Mean
2788155|NCT00607867|Primary|Change in Total Glucose Area at 5 Weeks From Baseline|The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.|Baseline and 5 weeks after dietary intervention||||mg hr/dl||Standard Error|Mean
2788156|NCT00607867|Secondary|Microalbumin Excretion|change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention||||mg/day||Standard Error|Mean
2788157|NCT00607867|Primary|Change in %Hemoglobin A1c at 5 Weeks From Baseline|Hemoglobin A1c measured before and after 5 weeks on the diet|Baseline and 5 weeks after dietary intervention||||Change in % A1c at 5 weeks from baseli||Standard Error|Mean
2788158|NCT00607815|Secondary|State-Trait Anxiety Scale|Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
2788159|NCT00607815|Secondary|State-Trait Anger Scale (STAXI)|Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
2788160|NCT00607815|Secondary|Beck Depression Inventory - II (BDI-II)|Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed.|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
2788161|NCT00607815|Primary|PTSD Checklist (PCL)|17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed|post-treatment, at 3 months and 1 year||||units on a scale||Standard Deviation|Mean
2788162|NCT00607815|Primary|Clinician Administered PTSD Scale|Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.|Post-treatment, at 3 months and 1 year|Generalized estimating equations (GEE) were used to test study hypotheses.|||units on a scale||Standard Deviation|Mean
2788163|NCT00607789|Secondary|Weekly Episodes|The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)|12 weeks|The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.|||Days||Standard Deviation|Mean
2788164|NCT00607789|Primary|Binge Eating Days|The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).|12 weeks|The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.|||Mean Number of days||Standard Deviation|Mean
2788165|NCT00607724|Secondary|PFS: Participants With BCC|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis. Number of participants censored for Stage 1+Stage 2 150 mg, and Stage 1+Stage 2 270 mg were 8 and 7 subjects, respectively, and no subject censored from Stage 1 540 mg group.|||months||95% Confidence Interval|Median
2788166|NCT00607724|Secondary|Progression-Free Survival (PFS): All Participants|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population. Number of participants censored for Stage 1 150 mg, 270 mg, and 540 mg were 1, 2, and 1 subjects, respectively and for Stage 2 BCC 150 mg, 270 mg, Stage 2 Safety Expansion Cohort 150 mg, and Stage 2 New Formulation 150 mg were 2, 6, 1, and 6 subjects, respectively.|||months||95% Confidence Interval|Median
2788167|NCT00607724|Secondary|Duration of Objective Response: Participants With BCC|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable participants; only participants with BCC who achieved a best overall response of CR or PR were included in the analysis.|||months||Full Range|Median
2788168|NCT00607724|Secondary|Duration of Objective Response: All Participants|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants who achieved a best overall response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2788169|NCT00607724|Secondary|Percentage of Participants With a BOR of CR or PR: Participants With Basal Cell Carcinoma|BOR was defined as the best objective response observed during the treatment period according to RECIST v1.0. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis.|||percentage of participants|||Number
2788170|NCT00607724|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): All Participants|BOR was defined as the best objective response (complete or partial response determined by two consecutive investigator assessments which were at least 28 days apart) observed during the treatment period according to RECIST v1.0. CR: disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population were those with measurable disease at baseline and who received at least 1 dose of GDC-0449 and either had a post-baseline tumor assessment or progressed before any tumor assessment.|||percentage of participants|||Number
2788171|NCT00607724|Secondary|Percentage of Participants With a Greater Than (>) 2-Fold Down-Modulation of GLI1 Expression in Skin Biopsy-Derived or Hair Follicle-Derived Messenger Ribonucleic Acid (mRNA)|Ribonucleic acid (RNA) was extracted from biopsy specimens of noninvolved skin or hair follicles at baseline and at 7 and 21 days after the start of daily drug therapy. Control mRNA was obtained from formalin-fixed, paraffin-embedded samples of normal skin and hair follicles from participants who were not enrolled in the study.|Baseline up to Day 29|"Pharmacodynamic-evaluable population included participants who had hair and/or skin samples available from Day 1 and at least one post-baseline sample while on study treatment. Here number of participants analyzed = participants evaluable for this measure and n= participants evaluable for the specific category."|||percentage of participants|||Number
2788186|NCT00607672|Secondary|Acute Kidney Injury|Acute kidney injury (AKI) was defined according to Acute Kidney Injury Network (AKIN) criteria,specifically any increase in subject serum creatinine concentration of 50% or 0.3 mg/dL (26.5 umol/L) within 72 hours of surgery.|From the start of surgery until postoperative day 3||||percentage of patients|||Number
2788187|NCT00607672|Secondary|New Onset Atrial Fibrillation|New onset atrial fibrillation based on electrocardiogram (ECG) rhythm strips with a duration longer than 10 seconds|From arrival in intensive care unit until discharge from hospital||||percentage of patients|||Number
2788172|NCT00607724|Primary|Accumulation Index (AI) After Multiple Doses of GDC-0449|AI was calculated using the formula [AI = AUC(0-24) on Day 15/AUC(0-24) on Day 1]. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AI was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AI was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AI.||||||
2788173|NCT00607724|Primary|AUC0-24 After Multiple Doses of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AUC0-24 was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AUC0-24.||||||
2788174|NCT00607724|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) After a Single Dose of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and - 5 minutes (pre-dose) on Day 8|PK-evaluable population.|||mcM*day||Standard Deviation|Mean
2788175|NCT00607724|Primary|Average Plasma Concentration at Steady State (Css, Avg) After Multiple Doses of GDC-0449|Steady state GDC−0449 plasma concentrations (Css) were calculated as an average of plasma concentrations from Study Day 21 (Stage 2) or Study Day 28 (Stage 1) onward.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|"PK-evaluable population. Here number of participants analyzed = participants evaluable for this measure."|||mcM||Standard Deviation|Mean
2788176|NCT00607724|Primary|Tmax After Multiple Doses of GDC-0449|Tmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax, and as Tmax was related to Cmax, it was also not estimated.||||||
2788177|NCT00607724|Primary|Time to Maximum Plasma Concentration (Tmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and - 5 minutes (pre-dose) on Day 8|PK-evaluable population.|||days||Full Range|Median
2788178|NCT00607724|Primary|Cmax After Multiple Doses of GDC-0449|Cmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax.||||||
2788179|NCT00607724|Primary|Maximum Observed Plasma Concentration (Cmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and pharmacodynamic (PD) data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and - 5 minutes (pre-dose) on Day 8|Pharmacokinetic (PK)-evaluable population included participants who had at least Day 1 PK samples available.|||micromolar (mcM)||Standard Deviation|Mean
2788180|NCT00607724|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as any Grade 3 or 4 hematologic or major organ toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) that occurred during the first 35 days after the initiation of study drug (Days 1−35) and was attributable to GDC-0449.|Up to Week 6|Safety-evaluable population.|||percentage of participants|||Number
2788181|NCT00607672|Primary|Interleukin-10 (IL-10) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by the IL-10 response|From the start of surgery until postoperative day 2||||pg/mL||Standard Error|Mean
2788182|NCT00607672|Primary|Interleukin-8 (IL-8) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-8|From the start of surgery until postoperative day 2||||pg/mL||Standard Error|Mean
2788183|NCT00607672|Primary|Interleukin-6 (IL-6) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-6|From the start of surgery until postoperative day 2||||pg/mL||Standard Error|Mean
2788184|NCT00607672|Secondary|Length of Hospital Stay||From the start of surgery until discharge from hospital||||days||Standard Error|Mean
2788193|NCT00607672|Primary|Tissue-type Plasminogen Activator (t-PA) Antigen Response|To compare the effects of angiotensin II type I (AT1) receptor antagonism or angiotensin-converting enzyme (ACE) inhibition versus placebo on the fibrinolytic responses to cardiopulmonary bypass (CPB) as measured by t-PA antigen response|From the start of surgery until postoperative day 2||||ng/mL||Standard Error|Mean
2788194|NCT00607620|Secondary|Alcohol Use Problems|The investigators will use the Short Inventory of Problems (SIP) as a continuous measure. The 16-item scale score ranges from 0-48 with higher scores indicating worse outcomes.|The investigators will assess at 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||units on a scale||Standard Error|Mean
2788195|NCT00607620|Secondary|Number of Binge Drinking Days|The investigators will use the Form 90 to assess the number of days in which a male participants consumed ≥5 alcoholic drinks and female participants consumed ≥4 alcoholic drinks|The investigators will assess at 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||days||Standard Error|Mean
2788196|NCT00607620|Secondary|Number of Abstinent Days|The investigators will use the Form 90 to assess the number of days within the last 90 days in which a patient did not consume alcohol.|The investigators will assess at 6- and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||days||Standard Error|Mean
2788197|NCT00607620|Primary|Alcohol Use Problems|The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.|The investigators will assess at baseline, 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||units on a scale||Standard Deviation|Mean
2788198|NCT00607620|Primary|Number of Participants With Hazardous Drinking|The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a dichotomous measure. AUDIT Scores of ≥8 for men and ≥5 for women indicate hazardous drinking.|The investigators will assess at baseline, 6-month and 12-month.|Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up|||Participants|||Count of Participants
2788199|NCT00607594|Secondary|Association Between Correlative Markers and Clinical Outcomes|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|At baseline, 6 months, and then at 1 year|data were not collected||||||
2788200|NCT00607594|Secondary|Patient Tolerability|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Weekly during treatment|Data were not collected||||||
2788201|NCT00607594|Secondary|Highest Grade Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.|Weekly during treatment||||highest grade|||Number
2788202|NCT00607594|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year (median, 6 months, and 1 year)|Only 17 patients were evaluable for response|||months||95% Confidence Interval|Median
2788203|NCT00607594|Secondary|Median Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year||||months||95% Confidence Interval|Median
2788204|NCT00607594|Secondary|Progression-free Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy|Only 17 patients were evaluable for response|||months||95% Confidence Interval|Median
2788205|NCT00607594|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in non-target lesions, or the appearance of new lesions.|Up to 1 year (median, 6 month, 1-year)||||months||95% Confidence Interval|Median
2788206|NCT00607594|Primary|Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)||Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks||||participants|||Number
2788207|NCT00607594|Primary|Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)|PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.|Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks||||participants|||Number
2788208|NCT00607477|Primary|Magnitude of Change in Blood Pressure||21 days|No participants analyzed due to poor accrual and insufficient numbers of participants.||||||
2788209|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steadystate.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||milliliter per kilogram||Standard Deviation|Mean
2789440|NCT00599248|Secondary|Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint|Visual and histological analysis of knee joint tissues to determine the number of patients with tissue overgrowth or transformation|29||||participants|||Number
2788210|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||milliliter/minute/kilogram||Standard Deviation|Mean
2788211|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Mean Residence Time From Time 0 to Infinity (MRTinf)|MRTinf is an average duration of the drug in the body from time zero to infinity, and is expressed in minutes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||minutes||Standard Deviation|Mean
2788212|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Elimination Half-Life (t1/2)|t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in minutes and derived from the terminal slope of the concentration versus time curve.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||minutes||Standard Deviation|Mean
2788213|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf)||Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."|||minute*nanogram per milliliter||Standard Deviation|Mean
2788214|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to the Final Time Point With a Concentration of at Least Lower Limit of Quantitation (AUClast)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.|||minute*nanogram per milliliter||Standard Deviation|Mean
2788215|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Time of Maximum Observed Serum Concentration (Tmax)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.|||minutes||Standard Deviation|Mean
2788216|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)||Weeks 1 and 27|Pharmacokinetic (PK) population was defined as all enrolled participants who had at least one serum concentration measurement available. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.|||nanogram per milliliter||Standard Deviation|Mean
2788217|NCT00607386|Secondary|Mean Change From Baseline to Week 53 in Normalized Urinary Glycosaminoglycan (GAG) Levels|Analysis of urinary GAG levels was performed at baseline, Week 18, Week 36, and Week 53 as an assessment of the pharmacodynamic effects of Elaprase (idursulfase).|Baseline, Weeks 18, 36 and 53|Safety population. In the categories listed below, 'N' signifies the number of participants evaluable for the timepoint.|||microgram/milligram creatinine||Standard Deviation|Mean
2788218|NCT00607386|Primary|Safety Evaluation|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs occurred after start of study treatment until 30 days after the last infusion of idursulfase, were reported.|From the start of study treatment until 30 days after the last infusion of idursulfase, up to 53 weeks|Safety population was defined as all enrolled participants who received at least one study dose (or any portion of a dose) of idursulfase.|||participants|||Number
2788219|NCT00607373|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2788220|NCT00607373|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2788221|NCT00607373|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2788222|NCT00607373|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2788223|NCT00607373|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||ratio||Standard Deviation|Mean
2790107|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2788224|NCT00607373|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2788225|NCT00607373|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2788226|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2788227|NCT00607373|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2788228|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2788229|NCT00607373|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Inter-Quartile Range|Median
2788230|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
2788231|NCT00607373|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2788232|NCT00607373|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2788233|NCT00607373|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2788234|NCT00607373|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
2788235|NCT00607373|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2788615|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
2788236|NCT00607373|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28 )|Full analysis set|||mg/dL||Standard Deviation|Mean
2788237|NCT00607373|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
2788238|NCT00607373|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. If the Study Day 1 and screening LDL-C values were >12% different (relative to the maximum value), then the screening value was not used, because the Study Day 1 value represents the best estimate of the patient's condition at the beginning of study drug administration. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.|||percentage of baseline||Standard Deviation|Mean
2788239|NCT00607321|Secondary|Number of Participant With Target Vessel Failure at 12 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|12 month|Includes all subjects receiving bifurcation stents and having evaluable data.|||participants|||Number
2788240|NCT00607321|Secondary|Number of Participants With Target Vessel Failure at 9 Months.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|9 month|Includes all subjects receiving bifurcation stents and having evaluable data|||participants|||Number
2788241|NCT00607321|Secondary|Number of Participants With Target Vessel Failure (TVF) at 6 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|6 month|Includes all patients receiving bifurcation stent and having evaluable data.|||participants|||Number
2788242|NCT00607321|Secondary|Device Success|Device success is reported as Historical-standard definition: attainment of <50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.|During index procedure|ITT included all subjects after a run-in subject at each site.|||participants|||Number
2788243|NCT00607321|Primary|Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|30 days||||Participants|||Number
2788244|NCT00607269|Secondary|Self-reported Sexual Behaviors at 12-month Follow-up|Count of recent (past 30 days) male sexual partners.|12 months||||Sexual Partners||Standard Deviation|Mean
2788245|NCT00607269|Secondary|Self-reported Psychiatric Symptoms at 12-month Follow-up.|As measured by the General Severity Index (GSI), a summary domain included on the Brief Symptom Inventory. The GSI combines information on both the number of symptoms described and the severity of those symptoms. Lower values on the GSI indicate less severe symptoms. Normative non-patient populations have been shown to have average GSI scores with a mean of 0.30 and a standard deviation of 0.31. Normative outpatient psychiatric patients have demonstrated GSI scores with a mean of 1.32 with a standard deviation of 0.72.|12 months||||Units of General Severity Index||Standard Deviation|Mean
2788246|NCT00607269|Primary|Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.||24 Weeks||||Proportion of Lvl 1 Clean Urine Samples|||Number
2788247|NCT00607269|Primary|Amount ($) Earned for Targeted Prosocial and Healthy Behaviors|Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1|24 Weeks||||$ Vouchers||Standard Deviation|Mean
2788248|NCT00607243|Secondary|Cell-mediate Immunity||14 or 28 days|||||||
2788249|NCT00607243|Secondary|Antibody Response||14 or 28 days|||||||
2788250|NCT00607243|Primary|Adverse Reactions||0-28 days|||||||
2788251|NCT00607243|Primary|Cutaneous Take Reaction|"The take reactionwas defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken."|7-9 day||||participants|||Number
2788252|NCT00607126|Secondary|PASAT|Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance|baseline, mid, completion, 3 months post training||||units on a scale||Standard Error|Mean
2789444|NCT00599248|Primary|Summary of Adverse Events|The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.|Through 28 days post-dosing|Intention-to-treat|||Adverse events|||Number
2788253|NCT00607126|Secondary|Fatigue|fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.|baseline, mid, completetion, 3 months post||||units on a scale||Standard Deviation|Mean
2788254|NCT00607126|Secondary|Distance|distance assessed by 6 minute walk test|baseline, mid point, end and 12 weeks after training||||feet||Standard Deviation|Mean
2788255|NCT00607126|Primary|Walking Speed as Assessed by 25' Timed Walk|This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.|at beginning,mid point, end and 12 weeks after intervention||||seconds||Standard Deviation|Mean
2788256|NCT00607113|Primary|Net Change Relative to Baseline in Tumor Blood Flow|Tumor blood flow (ml/min/100gm) determined by functional computed tomography (CT). Functional computed tomography (CT) at baseline, after first and third cycles (21 day cycles). Change (percentage) calculated as tumor blood flow measured at baseline compared to tumor blood flow measurement taken at end of Cycle 1, week 3 (21 days), and again at end of Cycle 3, Week 9 (63 days).|Baseline to end of Cycle 3 (63 days)||||ml/min/100gm||Standard Deviation|Mean
2788257|NCT00607087|Secondary|Total Daily Bolus Insulin Dose|dose of every increment administered for example before meals|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||Units||Standard Deviation|Mean
2788258|NCT00607087|Secondary|Total Daily Basal Insulin Infusion|dose of the basal insulin regimen administered throughout the 24-hour period|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||Units||Standard Deviation|Mean
2788259|NCT00607087|Secondary|Glycosylated Hemoglobin: HbA1c|Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage||Standard Deviation|Mean
2788260|NCT00607087|Secondary|Time Interval Between Infusion Set Changes in Routine|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~Changes in routine correspond to interval between changes according to patient use."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||hours||Standard Deviation|Mean
2788261|NCT00607087|Secondary|Time Interval Between Infusion Set Changes: All Changes|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~All changes include all the changes whatever the reason such as routine or requested by occurrence of events."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||hours||Standard Deviation|Mean
2788262|NCT00607087|Secondary|Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site|"Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.~Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.~Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.~Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||patients|||Number
2788263|NCT00607087|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year|Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events in patient-year||Standard Error|Mean
2788264|NCT00607087|Secondary|Rate of Severe Symptomatic Hypoglycemia Per Patient-year|"Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:~the event was associated with a measured blood glucose level below 36 mg/dL~or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events in patient-year||Standard Error|Mean
2788265|NCT00607087|Secondary|Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year|Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events in patient-year||Standard Error|Mean
2788266|NCT00607087|Secondary|Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
2788267|NCT00607087|Secondary|Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
2788268|NCT00607087|Secondary|Monthly Rate of Confirmed Infusion Set Occlusion||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
2788269|NCT00607087|Secondary|Percentage of Patients With at Least One Confirmed Infusion Set Occlusion|"Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
2788270|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
2788271|NCT00607087|Secondary|Percentage of Patients With at Least One Unexplained Hyperglycemia|Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
2788272|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||events per patient per month||Standard Error|Mean
2788273|NCT00607087|Primary|Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).|||percentage of patients||95% Confidence Interval|Number
2788274|NCT00607048|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months)|Data was not summarized as Human antihuman responses to CP-870893 were all below the limit of quantitation (endpoint titer of 4.32).||||||
2788284|NCT00607048|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng*mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set; N=number of participants who did not have pre-dose levels of CP-870893.|||hr*mcg/mL||Standard Deviation|Mean
2788275|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax|Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
2788276|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
2788277|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
2788278|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
2788279|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
2788280|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax)|Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set: All enrolled participants who started treatment and who had baseline and sufficient on-study samples to provide interpretable results. N=Number of participants contributing to the mean.|||percentage of cells||Standard Deviation|Mean
2788281|NCT00607048|Secondary|Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set. CYTO0 values = the lower limit of quantitation (LLOQ).|||pg/mL||Standard Deviation|Mean
2788282|NCT00607048|Secondary|Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX)|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2788283|NCT00607048|Secondary|Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD.|Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months)|All response-evaluable population: included all participants who had measurable disease, a baseline tumor assessment and who started treatment were considered evaluable for analysis of tumor response.|||participants|||Number
2788285|NCT00607048|Secondary|Maximum Observed Serum Concentration (Cmax)|Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set: all enrolled participants who started treatment and had baseline and sufficient on-study samples to provide interpretable results. N=number of participants who did not have pre-dose levels of CP-870893.|||mcg/mL||Standard Deviation|Mean
2788286|NCT00607048|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2.|Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21|Safety population: all participants who received at least 1 dose of study treatment.|||participants|||Number
2788287|NCT00607022|Primary|Implant Stability Scale (ISQ) Score Change After 16 Weeks|The objective of this study is to examine the change in implant stability upon three different loading regimens during the first sixteen weeks following implant placement. ISQ score (1-100), where higher score equals more stability, was assessed. The main hypotheses of the study are 1) Implant stability (ISQ) is minimally affected when physiologic load is applied to an implant during the healing process.|16 weeks||||units on a scale||Standard Deviation|Mean
2788288|NCT00606944|Secondary|Postoperative Complication||at postoperative day 30|||||||
2788289|NCT00606944|Secondary|Quality of Life|measured by SF-36|at postoperative day 30|||||||
2788290|NCT00606944|Secondary|Pain|score measured by the Visual Analog Scale|at postoperative day 30|||||||
2788291|NCT00606944|Secondary|Readmission Rate||at postoperative day 30|||||||
2788292|NCT00606944|Primary|Recovery|"recovery criteria must include all of the following~Tolerance of consecutive 3 soft bland diet~Unassisted ambulation~No necessity of analgesics~Afebrile without major complication"|at discharge|||||||
2788293|NCT00606944|Primary|Postoperative Complication During the First Admission||at discharge|||||||
2788294|NCT00606944|Primary|Quality of Life|measured by SF-36|at discharge|||||||
2788295|NCT00606944|Primary|Pain|score measured by the Visual Analog Scale|at discharge|||||||
2788296|NCT00606944|Primary|the Length of Hospital Stay|"discharge criteria~Tolerance of consecutive 3 soft bland diet~Unassisted ambulation~No necessity of analgesics~Afebrile without major complication~Willing to discharge"|at discharge|1 mortality case was excluded for analysis in the ERP group|||day||Inter-Quartile Range|Median
2788297|NCT00606931|Other Pre-specified|Number of Participants Who Tolerated the PET-Guided Biopsy Procedure|Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.|Within one week of completing PET-guided biopsy||||Participants|||Number
2788298|NCT00606931|Secondary|Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy|"Serious Adverse Events are defined as events that~Are fatal or life-threatening~Require in-patient hospitalization or prolong hospitalization~Result in permanent or significant disability/incapacity~Result in congenital abnormality/birth defect"|Within one week of completing PET-guided biopsy||||Participants|||Number
2788299|NCT00606931|Primary|Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.|"Success in completion of the PET guided biopsy of a suspicious lesion was determined by~Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR~Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent)."|within two days of obtaining histopathology of the lesion biopsied|All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants|||Number of lesions|||Number
2788300|NCT00606905|Primary|Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies||20 weeks gestation|47 women who achieved an index pregnancy, defined as the first pregnancy in the study, unless it resulted in a noneuploid miscarriage, ectopic, molar pregnancy or genetic termination, were analyzed.|||Successful pregnancies|||Number
2788301|NCT00606892|Secondary|Changes in Systolic and Diastolic Blood Pressure|The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).|||mm Hg||Standard Error|Mean
2788302|NCT00606892|Secondary|Heart Rate|The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).|||beats per minute||Standard Error|Mean
2788303|NCT00606892|Primary|Subjective Responses to Intravenous Nicotine|"The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from not at all (a score of 0) to extremely with a maximum score of 100."|30 minutes after each nicotine infusion|All participants who complete all interventions.|||millimeters||Standard Error|Mean
2788304|NCT00606892|Secondary|Cotinine Levels|Subject Cotinine Levels before each laboratory session.|Before each laboratory session on day 5|Subjects finishing the complete study. (n=12)|||ng/mL||Standard Deviation|Mean
2788323|NCT00606580|Secondary|Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion||Day 42||||participants|||Number
2788324|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98||Days 98|mITT dataset|||percentage of lesions|Participants|95% Confidence Interval|Number
2788305|NCT00606892|Secondary|Mean Reaction Time (RT) on Modified Stroop Task.|A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).|pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)|Data from all subjects who completed both experimental sessions (nicotine infusion after 4 days of placebo and also 4 days of varneicline, n=12) are presented. RT's < 100 ms, or > 1501 ms were excluded from the analysis (>3 SD's of the mean). The data presented are the mean RT's to identifying word colors under each treatment condition.|||milliseconds||Standard Deviation|Mean
2788306|NCT00606801|Secondary|Performance on the Modified Stroop Task (Cocaine-Stroop)|The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.|Baseline, Day 5 and Day 10||||milliseconds||Standard Deviation|Mean
2788307|NCT00606801|Secondary|Performance on the Sustained Attention to Response Task (SART).|"The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. Cocaine users are know to have deficits in response inhibition on such tasks. The number of errors on NoGo and Go trials, as well as the mean reaction time (RT in milliseconds) for correct responses on Go Trials were measured.~Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors."|Baseline, Day 5 and Day 10|Participants analyzed are those that completed the treatment phase.|||milliseconds||Standard Deviation|Mean
2788308|NCT00606801|Primary|Performance on 3 Cognitive Tests From the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP, PAL and PRM.|Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers, total hits, correct rejections and A' (sensitivity to target sequences) were determined. Paired Associate Learning (PAL) measures visual memory and new learning by testing a the ability to remember the initial location of a pattern after it is re-presented in the middle of the screen. Errors result in a reminder presentation of the original location. The stages completed and number of errors are measures of interest. Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern.|Baseline, Day 5 and Day 10|There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.|||milliseconds||Standard Deviation|Mean
2788309|NCT00606684|Secondary|Time to >= 100 Milliliter (mL) Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieve >=100 mL increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to >= 100mL increase from Baseline (on Day 1) is defined as the time until the first post-dose FEV1 (on Day 1) is >= 100mL above Baseline FEV1. Time to >= 100mL increase from Baseline (on Day 1) was calculated only if there was at least one non-missing FEV1 value recorded within the first hour of dosing. Time to >= 100mL increase from Baseline was assessed over the 0-4 time period and only used lung function data recorded up to 6 hours post the Day 1 dose. Participants who did not achieve >= 100mL increase from Baseline over this time period were censored.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.|||Minutes||Full Range|Median
2788310|NCT00606684|Secondary|Time to >= 12% Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Forced expiratory volume in one second (FEV1) is a measure of lung function defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieved a >=12% increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 on Day 1.Time to >= 12% increase from Baseline (on Day 1) is defined as the time when the first post-dose FEV1 (on Day 1) is >=12% above Baseline FEV1. Time to >= 12% increase from Baseline was assessed over the 0-4 hour time period and only used lung function data recorded up to 6 hours post the Day 1 dose.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.|||Minutes||Full Range|Median
2788311|NCT00606684|Secondary|Time-adjusted Area Under the Curve (AUC) (i.e. Weighted Mean Change From Baseline) for 24 Hour Serial FEV1 on Days 1 and 28|Weighted mean was derived by calculating the AUC, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24 hour serial FEV1 measures on Day 1 and Day 28 minus the Baseline value. Serial FEV1 measurements were taken on Day 1 and Day 28 (post-dose FEV1 after 5, 15, 30 minutes and 1, 2, 4, 8, 12, 23 and 24 hours). AUC was calculated only when there was at least 3 non-missing values between 0 and 24 hours and must have a value at 23 or 24 hours. Analysis performed used a repeated measures model with covariates of treatment, baseline, sex, age, smoking status (at Screening), reversibility stratum, Day (nominal), day by Baseline, and day by treatment interactions.|Baseline to Day 28|ITT Population. The number of participants presented represents those with data available at either of time points being presented. The numbers given in the category titles represent the number of participants with data available at the time point given.|||Liters||Standard Error|Least Squares Mean
2788312|NCT00606684|Primary|Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).|Baseline (BL) and Day 29|Intent-to-Treat (ITT) Population: all participants who were randomized to trt and received >= 1 dose of study medication. When the endpoint was missing, the last valid non-missing on-trt, post-BL trough assessment was used instead. Only those participants available at the specified time points without missing covariate information were analyzed.|||Liters||Standard Error|Least Squares Mean
2788313|NCT00606632|Secondary|Negative Predictive Value (NPV)|Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Proportion of participants|||Number
2788314|NCT00606632|Secondary|Positive Predictive Value (PPV)|The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Protportion of participants|||Number
2788315|NCT00606632|Secondary|Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging|The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Proportion of participants|||Number
2788316|NCT00606632|Primary|Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.|"Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images.~Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC."|6 months|ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers|||Proportion of participants||95% Confidence Interval|Mean
2788317|NCT00606593|Secondary|Mean Total Sleep Time (TST)|"TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).~Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.|||minutes||Standard Deviation|Mean
2788318|NCT00606593|Primary|Mean Wake Time After Sleep Onset (WASO)|"WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.~Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.|||minutes||Standard Deviation|Mean
2788319|NCT00606580|Secondary|Number of Subjects With a Relapse on or After Day 42||Day 168||||participants|||Number
2788320|NCT00606580|Secondary|Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42||Day 42|mITT dataset|||Ulcerated lesions|Participants||Number
2788321|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,|Day 168|mITT dataset|||participants|||Number
2788322|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse|Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42|Day 168|mITT population|||participants|||Number
2788327|NCT00606580|Secondary|Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up||Days 42, 49, and 98|mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.|||percentage of participants||95% Confidence Interval|Number
2788328|NCT00606580|Secondary|Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse|For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.|Day 42|mITT dataset|||percentage of participants||95% Confidence Interval|Number
2788329|NCT00606580|Secondary|Final Clinical Cure Rate (Per Protocol Dataset)|Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.|Day 42, 98, and 168|Per protocol – all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.|||participants|||Number
2788330|NCT00606580|Primary|Final Clinical Cure Rate|"Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows:~Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation.~Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98.~Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168.~Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse."|Day 42, 98, and 168|Modified intention-to-treat (mITT) – all subjects randomized who received at least one treatment of study drug.|||participants|||Number
2788331|NCT00606554|Secondary|Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)|This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.|Duration of weaning (median 2 days)|Number of participants with adverse event during weaning|||Participants|||Number
2788332|NCT00606554|Secondary|Number of Spontaneous Breathing Trials Prior to Extubation||from start of weaning to liberation from ventilator, on average 1-2 days||||SBTs||Inter-Quartile Range|Median
2788333|NCT00606554|Secondary|Sedation Requirements|measure was not recorded|during weaning, on average 1-2 days|Data were not recorded||||||
2788334|NCT00606554|Secondary|Inpatient Mortality|proportion of patients in each arm who died in the hospital|28 days|ITT|||Participants|||Number
2788335|NCT00606554|Secondary|Duration of Hospitalization||from start of weaning to discharge from hospital, on average 1-2 weeks||||days||Inter-Quartile Range|Median
2788336|NCT00606554|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation from weaning initiation|from start of weaning to liberation from ventilator, on average 1-2 days||||days||Inter-Quartile Range|Median
2788337|NCT00606554|Secondary|Duration of ICU Stay|Duration of ICU stay after weaning initiation|from start of weaning to discharge from ICU, on average 1-2 weeks||||days||Inter-Quartile Range|Median
2788338|NCT00606554|Primary|Duration of Weaning|Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.|Continuous (median weaning duration was 2 days)|ITT|||Days||Inter-Quartile Range|Median
2788339|NCT00606502|Secondary|Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib||Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.~Grade 3 = Severe~Grade 4 = Life-threatening or disabling"|||Treated Participants|||Number
2788340|NCT00606502|Secondary|Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib|PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.|||months||95% Confidence Interval|Median
2788341|NCT00606502|Secondary|Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib|Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.|||Participants|||Number
2788342|NCT00606502|Primary|Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib|OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.|Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.||||Months Survival||95% Confidence Interval|Median
2788343|NCT00606489|Primary|Temperature|Area under the curve temperature from baseline to hour 24 following initiation of treatment.|0 to 24 hours|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.|||Degree Celcius times hours (AUC-T)||Standard Error|Least Squares Mean
2788344|NCT00606320|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation||||scores on a scale||Standard Deviation|Mean
2788345|NCT00606320|Primary|Young Mania Rating Scale (YMRS)|YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.|baseline (Day 1 of preceding study), Day 154 or at discontinuation||||scores on a scale||Standard Deviation|Mean
2788346|NCT00606307|Secondary|Number of Subject Experiencing an Adverse Event|"An adverse event (AE) is any untoward occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~The adverse events must to be followed to the end of study (28 days after the last study drug intake).~A serious AE (SAE) is defined as an untoward (unfavourable) medical occurrence that at any dose results in death, or is life-threatening or requires inpatient hospitalisation or prolongation of existing hospitalisation, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect."|At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at end of treatment visit|safety population: all recruited patients who received at least one dose of the study medication.|||Participants|||Count of Participants
2788347|NCT00606307|Secondary|Change in JAK2 Mutated Allele Burden|"This outcome was assessed by quantitative real time Polymerase Chain Reaction (RT PCR).~At each time point, the number of patients is the following:~Screening: N=29 Week 12: N=20 Week 24: N=18 EOT: N=24. End of treatment corresponds to the last visit performed before treatment discontinuation."|At screening, at week 12, at week 24, at the end of treatment (EOT) visit|Intent-to-treat population: all recruited patients who received study medication and for whom at least one on-study tumour evaluation is available.|||percentage of change in allele burden||Standard Deviation|Mean
2788348|NCT00606307|Primary|Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response|"Patients with Objective Response were defined as those patients achieving a complete, major, moderate or minor (only for Myelofibrosis patients) response during the experimental treatment course.~The best response is reported hereunder by intensity of response."|Every single week from week 1 to week 24 of treatment|ITT population: all recruited patients who received study medication and for whom at least one on-study tumour evaluation is available.|||Participants|||Count of Participants
2788349|NCT00606281|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA."|Day1, Day21|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on a scale||Standard Error|Least Squares Mean
2788350|NCT00606281|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Day1, Day21|Full analysis set (FAS): The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on a scale||Standard Error|Least Squares Mean
2788351|NCT00606229|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)|"Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania)~The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)"|Day 1 and Daty 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)|||scores on a scale||Standard Deviation|Mean
2788419|NCT00605722|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||Months||95% Confidence Interval|Median
2788352|NCT00606229|Primary|Young Mania Rating Scale (YMRS)|"Mean change from baseline (Day 1) to endpoint in the YMRS total score~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~Total score range is 0 to 60, and the higher value represents worsen."|Day 1 and Day 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)|||scores on a scale||Standard Deviation|Mean
2788353|NCT00606177|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group.~CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill)."|Baseline (Day 1 of preceding study), Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on scale||Standard Deviation|Mean
2788354|NCT00606177|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.|||scores on a scale||Standard Deviation|Mean
2788355|NCT00606138|Secondary|Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment||Month 6||||number of PDR complications|||Number
2788356|NCT00606138|Secondary|Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing||Week 1, 2, 4; Month 2, 3, 4, 5, 6|||||||
2788357|NCT00606138|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters||Week 4; Month 6||||lines of vision gained||Standard Deviation|Mean
2788358|NCT00606138|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||Week 1, 2, 4; Month 2, 3, 4, 5, 6|||||||
2788359|NCT00606138|Primary|Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination||Month 6||||number of events|||Number
2788360|NCT00606138|Primary|The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)||Week 4; Month 6||||percentage of change (mean)||Standard Deviation|Mean
2788361|NCT00606138|Primary|The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)|This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.|Week 4; Month 6||||percentage of change in area (mean)||Standard Deviation|Mean
2788362|NCT00606086|Primary|EVR (Early Virologic Response)|Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.|At 12 weeks of treatment|One hundred forty subjects were randomized, only 133 subjects received at least one dose of study drug. Subjects who did not receive at least one dose of study drug were removed from the analysis.|||percentage of participants|||Number
2788363|NCT00606047|Primary|Prevalence of Femoroacetabular Impingement (FAI)|Prevalence of femoroacetabular impingement (FAI), a newly recognized cause of early arthritis of the hip, will be investigated by means of hip MRI to evaluate for abnormal morphology of the anterior head-neck junction of the femur. Participant MRIs were reviewed by two independent radiologists. The prevalence of FAI was calculated as determined by an abnormal alpha angle (greater than 50.5 degrees).|Pre-operative on Day of MRI||||Participants|||Count of Participants
2788364|NCT00606034|Secondary|Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)|Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.|Baseline versus 1 year|per protocol|||percent satisfaction||Standard Deviation|Mean
2788365|NCT00606034|Secondary|Percentage of Time Spent in Hypoglycemia|For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.|baseline versus 12 months|ITT (LOCF for 1 subject)|||percent of time spent in hypoglycemia||Standard Deviation|Mean
2788366|NCT00606034|Primary|Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)|HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.|1 year|Per Protocol|||HbA1c percentage||Standard Deviation|Mean
2788455|NCT00605423|Primary|Mean Change From Baseline in Visual Acuity|Visual acuity is measured using ETDRS charts at 4 meters.|6 mos||||ETDRS letters||Standard Deviation|Mean
2788456|NCT00605384|Secondary|Number of Participants With Genotypic Resistance Based on Analysis of Samples From Participants With HBV DNA ≥ 50 IU/mL at Weeks 48 and 96|HBV DNA ≥ 50 IU/mL = approximately 300 copies/mL|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2788367|NCT00606021|Secondary|Tumor Response Rate and Disease Control Rate After Induction Phase (IP)|Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Randomization to measured PD up to 31.4 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.|||percentage of participants||95% Confidence Interval|Number
2788368|NCT00606021|Secondary|Number of Participants With Adverse Events (AEs) During Overall Period|The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.|First dose of study drug during IP through overall study completion (up to 34.3) months|Participants who took at least one dose of study drug during IP, and randomized to maintenance phase.|||participants|||Number
2788369|NCT00606021|Secondary|Overall Survival During Overall Period (IP + MP)|Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.|First dose of study drug during IP to PD or date of death from any cause up to 34.1 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.|||months||95% Confidence Interval|Median
2788370|NCT00606021|Secondary|Overall Survival During Maintenance Phase|Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.|Randomization to PD or date of death from any cause up to 31.3 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.|||months||95% Confidence Interval|Median
2788371|NCT00606021|Secondary|Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])|Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.|First dose of study drug during IP to PD or date of death from any cause up to 33.6 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.|||months||95% Confidence Interval|Median
2788372|NCT00606021|Primary|Progression Free Survival During Maintenance Phase|Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.|Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.|||months||95% Confidence Interval|Median
2788373|NCT00606008|Secondary|Number of Participants With Related Grade 3 and Greater Adverse Events|To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).|12 Months|All participants|||Participants|||Number
2788374|NCT00606008|Secondary|Best Overall Response|To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).|12 Months|All participants|||Participants|||Number
2788375|NCT00606008|Primary|Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse|Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.|6 Months|All participants|||Participants|||Number
2788376|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Drinking Status|Number of participants with responders of Sertraline to determine whether drinking status is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788377|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788378|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug|Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788457|NCT00605384|Secondary|Number of Participants With HBs Seroconversion (HBsAg Loss and Presence of HBsAb) at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAb = HBsAg antibodies. HBs Seroconversion = HBsAg loss and presence of HBseAb|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2788379|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788380|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788381|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788382|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.|||participants|||Number
2788383|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788384|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788385|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788386|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788387|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788388|NCT00605917|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||events|||Number
2788389|NCT00605917|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.|||participants|||Number
2788390|NCT00605904|Primary|Alcohol Craving Rating in Response to Yohimbine Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)|||Units on a scale||Standard Error|Mean
2788391|NCT00605904|Primary|Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)|||Units on a scale||Standard Error|Mean
2788392|NCT00605904|Primary|Alcohol Craving Rating in Response to Saline Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)|||Units on a scale||Standard Error|Mean
2788393|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788394|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Age|Number of participants with responders of Sertraline to determine whether age is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788395|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not|Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788396|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788397|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient|Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788398|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride|Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788399|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity|Number of participants with responders of Sertraline to determine whether target disease severity is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788400|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788401|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788402|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788403|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788404|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788405|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788406|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788407|NCT00605865|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.|||events|||Number
2788408|NCT00605865|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 16 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.|||participants|||Number
2788409|NCT00605839|Primary|Quality of Parent-child Relationship|The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children's perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.|Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.|Everyone who completed the study|||units on a scale||95% Confidence Interval|Mean
2788410|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788411|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies|Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2788412|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788413|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||participants|||Number
2788414|NCT00605813|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline.|||events|||Number
2788415|NCT00605813|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.|||events|||Number
2788416|NCT00605722|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Up to 107 Weeks|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
2788417|NCT00605722|Secondary|Overall Survival (OS)|OS was defined as the time period in months from the start of study drug treatment to death.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||months||95% Confidence Interval|Median
2788418|NCT00605722|Secondary|Progression-free Survival (PFS)|PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug. Participants were censored at the last follow-up visit.|||months||95% Confidence Interval|Median
2788420|NCT00605722|Secondary|Disease Control Rate (DCR)|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||Percentage of participants||95% Confidence Interval|Number
2788421|NCT00605722|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR). Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.|||percentage of participants||95% Confidence Interval|Number
2788422|NCT00605722|Primary|Percentage of Participants With Progression-free Survival (PFS)|Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug. Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 16|Intent-to-treat population included all participants who received study drug. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease.|||percentage of participants||95% Confidence Interval|Number
2788423|NCT00605696|Secondary|Murray Lung Injury Score|Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score.|Measured at Day 3|Change in Murray Lung Injury score from Day 3 to Day 0 (baseline)|||units on a scale||Standard Deviation|Mean
2788424|NCT00605696|Primary|Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen||Measured at Day 1, 3 and 7|Although blood samples were collected, there were no bioassays perfomed and therefore no data were collected from any study participants.||||||
2788425|NCT00605657|Secondary|To Determine Whether the Treatment Alters, in Favorable Directions, Laboratory Markers of ALPS (e.g., Number of DNT Cells, Immunoglobin Levels, Vitamin B12 Levels, IL-10 Levels, Autoantibody Titers, Fas Mediated Apoptosis)||3 monthly (12 week) intervals|outcome measure not assessed because 0 participants had a response||||||
2788426|NCT00605657|Primary|Number of Participants With Response|Reduction of lymph node and/or spleen size measured by CT imaging, or physical exam and abdominal ultrasound. A clinical response is defined as a greater than 40% reduction in lymph node size and/or greater than 40% reduction in spleen size. A CT scan with contrast measured lymph node size as well as spleen size.|3 monthly (12 week) intervals||||participants|||Number
2788427|NCT00605566|Secondary|1-year Survival Rate|Survival rate at 1 year.|1 year||||percentage of participants|||Number
2788428|NCT00605566|Secondary|Overall Survival (OS)||Assessed from start of study treatment until death, assessed up to 7 years.||||months||95% Confidence Interval|Median
2788429|NCT00605566|Secondary|Progression-free Survival (PFS)|Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of measured lesions.|Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years||||months||95% Confidence Interval|Median
2788430|NCT00605566|Primary|Association Between p-Shift Changes and Treatment Efficacy of Individual Dose Adjustment of Sorafenib|"A phosphoshift (pShift) flow cytometry-based test that measures RAF signal transduction capacity in peripheral blood cells was used in order to predict clinical course and/or guide individual dose-titration. Positive pShift values denote stimulation of RAF signal transduction, whereas negative pShift values denote inhibition of RAF signal transduction as measured by flow-cytometry.~Associations between pShift changes and treatment efficacy were measured using progression-free survival (PFS) and overall survival (OS)."|Assessed from start of study treatment until death, assessed up to 7 years.|6 patients experienced a pharmacodynamic pShift change that was classified as positive, 16 experienced a negative pShift.|||months||95% Confidence Interval|Median
2788431|NCT00605566|Primary|Efficacy of Combination Sorafenib Plus Metronomic Cyclophosphamide in Advanced, Progressive NET, as Measured by the Objective Response Rate (ORR).|"Objective response (complete and partial) evaluated using RECIST criteria. Complete response (CR): disappearance of all clinical and radiological evidence of tumour (both target and non-target).~Partial response (PR): at least a 30% decrease in the sum of longest diameter of target lesions."|Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years|19 out of 22 patients were evaluable for response.|||Participants|||Count of Participants
2788458|NCT00605384|Secondary|Number of Participants With Hepatitis-B-Virus Surface Antigen of the (HBsAg) Loss at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2788432|NCT00605540|Primary|Health Status|Saint George's Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status. SGRQ includes three domains: symptoms, activities and impact of the disease. Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8, respectively). A total score is also calculated based on the results of three domains, with a score maximum of 3989.4. The total score is referred to as the percentage achieved by the patient related to this maximum score. Minimum score means there is no impairment in the health status and high score means maximum dysfunction.|Baseline and after three years||||Percentage of total score||Standard Deviation|Mean
2788433|NCT00605540|Primary|Dyspnea|Dyspnea was evaluated by Medical Research Council scale (MRC). MRC scale consists of only five items and it is based on activities that cause dyspnea. The patient reports the degree of dyspnea by choosing a value between 1 and 5. A higher number indicates greater sensation of dyspnea.|Baseline and after three years||||Scores on a scale||Inter-Quartile Range|Median
2788434|NCT00605540|Primary|Body Composition|Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.|Baseline and after three years||||Kg/m^2||Inter-Quartile Range|Median
2788435|NCT00605540|Primary|Exercise Tolerance|Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min. A research assistant timed the walk, and standardized verbal encouragement was given.|Baseline and after three years||||meters||Standard Deviation|Mean
2788436|NCT00605540|Primary|Forced Expiratory Volume in the First Second (FEV1)|FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.|Baseline and after three years|The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.|||Percentage predicted||Inter-Quartile Range|Median
2788437|NCT00605475|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency|An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)|All randomized participants who received study medication were included in the Safety Analysis|||Participants|||Number
2788438|NCT00605475|Secondary|β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )|β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||percent β-cell Function||Standard Error|Geometric Mean
2788439|NCT00605475|Secondary|Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)|Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||units on a scale||Standard Error|Geometric Mean
2788440|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Fructosamine Level|Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||µmol/L||Standard Error|Least Squares Mean
2788441|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )|Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||mmol/L||Standard Error|Least Squares Mean
2788442|NCT00605475|Secondary|Insulinogenic Index, 0 - 30 Minutes|"Insulinogenic index (0-30 min)~[Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]~[insulin (μIU/mL) at 30 min - insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min - glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||units on a scale||Standard Error|Geometric Mean
2788459|NCT00605384|Secondary|Number of Participants Who Were HBeAg-positive at Baseline With HBe Seroconversion at Weeks 48 and 96|HBe seroconversion = HBeAg loss and presence of hepatitis B e-antibody (HBeAb)|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2789623|NCT00596934|Secondary|Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months|ALT value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||IU/L||Standard Deviation|Mean
2788443|NCT00605475|Secondary|Insulin Sensitivity Index ( ISI ) at Day 28, Day 48|Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||units on a scale||Standard Error|Geometric Mean
2788444|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours|Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol/min/m^2||Standard Error|Least Squares Mean
2788445|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours|"Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:~Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
2788446|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol/pmol||Standard Error|Least Squares Mean
2788447|NCT00605475|Primary|Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )|Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||mmol*h/L||Standard Error|Least Squares Mean
2788448|NCT00605475|Secondary|Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol*h/L||Standard Error|Least Squares Mean
2788449|NCT00605475|Secondary|Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol*h/L||Standard Error|Least Squares Mean
2788450|NCT00605475|Secondary|Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||µIU*h/mL||Standard Error|Least Squares Mean
2788451|NCT00605475|Primary|Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)|Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||percent||Standard Error|Least Squares Mean
2788452|NCT00605475|Secondary|Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.|||pmol*h/L||Standard Error|Least Squares Mean
2788453|NCT00605423|Secondary|Change in IOP From Baseline|IOP stands for intra ocular pressure|6 mos||||mmHg||Standard Deviation|Mean
2788454|NCT00605423|Secondary|Number of Patients Developing Cataracts||6 mos||||participants|||Number
2788460|NCT00605384|Secondary|Number of Participants Who Were Hepatitis B E-antigen (HBeAg)-Positive at Baseline With Loss of HBeAg at Weeks 48 and 96|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication.|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.|||Participants|||Number
2788461|NCT00605384|Secondary|Number of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieved ALT Normalization (≤ 1 x ULN) at Weeks 48 and 96||Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||Participants|||Number
2788462|NCT00605384|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Weeks 48 and 96|by PCR, using the Roche COBAS®TaqMan - HPS assay|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.|||log10||Standard Deviation|Mean
2788463|NCT00605384|Secondary|HBV DNA Values at Weeks 48 and 96|Number of Participants with HBV DNA <LLD (4.8); LLD to <50; 50 to <172; 172 to <1,720; 1,720 to <17,200; and ≥17,200 IU/mL (<LLD (28); 28 to <300; 300 to <1,000; 1,000 to <10,000; 10,000 to <100,000; and ≥100,000 copies/mL by PCR, using the Roche COBAS®TaqMan - HPS assay|Weeks 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2788464|NCT00605384|Secondary|Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96|by PCR, using the Roche for the Roche COBAS® TaqMan - HPS assay. LLD = 4.8 IU/mL (approximately 28 copies/mL)|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2788465|NCT00605384|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.|Day 1 through end of treatment (Week 100 +/- 5 days)|All treated participants. Timeframe for Outcome Measure revised due to study termination. (Study Completion Date=February 2009).|||participants|||Number
2788466|NCT00605384|Secondary|Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96|by PCR, using the Roche COBAS®TaqMan - HPS assay; HBV DNA < 50 IU/mL = approximately 300 copies/mL.|Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.|||participants|||Number
2788467|NCT00605384|Primary|Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48|using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA < 50 IU/mL = approximately 300 copies/mL|Week 48|Due to early study termination, none of the efficacy endpoints were analyzed.|||Participants|||Number
2788468|NCT00605358|Primary|The Primary Outcome is Engagement Defined as at Least One Visit With a Mental Health Provider Who Can Offer Treatment of Depression.|"Engagement was defined as at least one visit with a mental health provider, due to the fact that in some treatment settings, the initial evaluation and the onset of treatment both took place in the first visit.~The primary outcome, engagement, was counted if the participant had engaged in mental health treatment by EITHER 12 weeks OR 24 weeks, based on research suggesting that older adults may take up to 6 months to follow through on a referral.~Therefore, while there is only a single primary outcome (engaged or not), it could be fulfilled at either of the two follow-up time points, at 12 or 24 weeks."|12 and 24 weeks||||percentage of participants|||Number
2788469|NCT00605345|Secondary|Incidence of RBC Transfusions|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis performed with the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||participants|||Number
2788470|NCT00605345|Secondary|Percentage of Participants Needing Dose Adjustments|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis was performed on the safety population.|||percentage of participants|||Number
2788471|NCT00605345|Secondary|Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)|Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.|Weeks 16-28|Analysis was performed using the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||days||Standard Deviation|Mean
2788472|NCT00605345|Secondary|Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)||Weeks 16-28|Analysis performed with intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||percentage of participants|||Number
2788473|NCT00605345|Secondary|Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)|Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.|Baseline to 28 weeks|Analysis performed in the Intent toTreat (ITT) population, which includes all participants receiving at least one dose of the study drug.|||g/dL||Standard Deviation|Mean
2788474|NCT00605345|Primary|The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range|Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.|Weeks 16-28|Analysis was performed in the per protocol (PP) population.|||percentage of participants||95% Confidence Interval|Number
2788475|NCT00605319|Primary|Postvoid Residual Volume (PVR)|Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.|screening (Month 0), 2-months, 3-months, 7-months||||mL||Standard Deviation|Mean
2788478|NCT00605319|Primary|International Prostate Symptom Score (IPSS) Quality of Life (QoL)|IPSS Quality of Life (QoL) is one question used to assess how the patient's symptoms affect their quality of life. A score ranges from 1 to 6, with 6 being the worse outcome.|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
2788479|NCT00605319|Primary|IPSS Nocturia|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with nocturia meaning individuals who wake up during sleeping hours to urinate.|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
2788480|NCT00605319|Primary|IPSS Irritative|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with irritative symptoms which includes frequency, urgency, nocturia and urge incontinence|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
2788481|NCT00605319|Primary|IPSS Obstructive|International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with obstructive symptoms which includes hesitancy or difficulty initiating the stream, straining to void, a reduced flow, an intermittent stream or a sensation of incomplete emptying.|screening (Month 0), 2-months, 3-months, 7-months||||units on a scale||Standard Deviation|Mean
2788482|NCT00605306|Secondary|Levels of Serum Cortisol Over Time|At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants|||mmol/L||Standard Deviation|Mean
2788483|NCT00605306|Secondary|Levels of Plasma Glucose Over Time|At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants|||mmol/L||Standard Deviation|Mean
2788484|NCT00605306|Secondary|Levels of Serum Potassium Over Time|At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants|||mmol/L||Standard Deviation|Mean
2788485|NCT00605306|Primary|Participants With Adverse Events|"An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.~A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above."|15 days|All participants|||participants|||Number
2788486|NCT00605293|Secondary|Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP|RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|DTP (Week 0 to 15) up to EEP (Week 16 to 23)|ITT population|||percentage of participants|||Number
2788487|NCT00605293|Secondary|Percentage of Participants Who Required Dose Adjustments During the DTP and EEP||DTP (Week 0 to 15) and EEP (Week 16 to 23)|"Safety population included all those participants who were treated with at least one dose of the trial medication and had a safety follow-up, whether withdrawn prematurely or not. Here, n = participants who were evaluable for each category, for respective arm groups."|||percentage of participants|||Number
2788488|NCT00605293|Secondary|Mean Time Spent in Hb Range 10-12 g/dL||SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)|ITT population. Here, n = participants who were evaluable for each category, for respective arm groups.|||days||Standard Deviation|Mean
2788489|NCT00605293|Secondary|Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP|Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.|EEP (Week 16 to 23)|ITT population|||percentage of participants|||Number
2788490|NCT00605293|Secondary|Change in Hb Concentrations Between Baseline SVP and the EEP|Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).|SVP (Week -4 to -1), EEP (Week 16 to 23)|ITT population.|||g/dL||Standard Deviation|Mean
2788505|NCT00605267|Secondary|Endocrine Subscale (ES)|"Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.~Score range: 0-72"|Assessed at baseline and after 24 weeks of treatment|Difference of Endocrine Subscale (ES) = ES at 24 weeks – ES at baseline.|||ES score||Standard Deviation|Mean
2788491|NCT00605293|Primary|Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP|Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.|EEP (Week 16 to 23)|Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations.|||percentage of participants||95% Confidence Interval|Number
2788492|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 2|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|2 years|FAS2 population|||Participants|||Number
2788493|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 1|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|1 year|MITT1 population|||Participants|||Number
2788494|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 2 Years|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 2|FAS2 population. LOCF.|||Scores on a scale||Standard Deviation|Mean
2788495|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 1 Year|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 1|MITT1 population. LOCF.|||scores on a scale||Standard Deviation|Mean
2788496|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
2788497|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
2788498|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
2788499|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.|||Eyes|||Number
2788500|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|FAS2 population. LOCF.|||Participants|||Number
2788501|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 1|MITT1 population. LOCF.|||Participants|||Number
2788502|NCT00605280|Secondary|Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|Full Analysis Set (FAS)2 population:participants who had same treatment for 102 weeks (pegaptanib sodium or sham on/before Week 96) with baseline VA assessment, who met the following: had at least 1 post baseline VA within 2 years, before entry into the Year 3 open-label extension phase, or before withdrawing from the study prior to Week 102. LOCF.|||Participants|||Number
2788503|NCT00605280|Primary|Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year|Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts|Baseline, Year 1|Modified Intent-to-Treat (MITT)1 population:participants with at least 1 dose of study treatment who completed baseline VA, had at least 1 post baseline VA assessment within 1 year; 2 sites not analyzed due to Good Clinical Practice deviations; the 0.03 and 0.003mg pegaptanib arms not analyzed for efficacy. Last Observation Carried Forward (LOCF).|||Participants|||Number
2788504|NCT00605267|Secondary|Anastrozole Plasma Concentrations (Cmin)|Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.|Assessed at week 12||||ng/mL||Full Range|Geometric Mean
2788506|NCT00605267|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B)|"Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.~FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).~Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI."|Assessed at baseline and after 24 weeks of treatment|"Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS."|||Trial Outcome Index (TOI) (Prorated)||Standard Deviation|Mean
2788507|NCT00605267|Secondary|Histopathological Response Rate (HRR)|Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)|Assessed at baseline and after 24 weeks of treatment||||Percentage of Participants|||Number
2788508|NCT00605267|Secondary|Human Epidermal Growth Factor Receptor 2 (HER2) Status|HER2 status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment||||Participants|||Number
2788509|NCT00605267|Secondary|Progesterone Receptor (PgR) Status|PgR status in the ITT population is categorized as Positive or Negative.|Assessed at baseline and after 24 weeks of treatment||||Participants|||Number
2788510|NCT00605267|Secondary|Oestrogen Receptor (ER) Status|ER status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment||||Participants|||Number
2788511|NCT00605267|Secondary|Serum Oestradiol (E2) Concentrations|Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment||||Ratio||Standard Deviation|Mean
2788512|NCT00605267|Secondary|Serum Oestrone (E1) Concentrations|Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment||||Ratio||Standard Deviation|Mean
2788513|NCT00605267|Secondary|Bone Turnover Marker (NTX)|Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks|Assessed at baseline and after 24 weeks of treatment||||nmolBCE(Bone Collagen Equivalent) /L||Standard Deviation|Mean
2788514|NCT00605267|Secondary|Bone Turnover Marker (BAP) CLEIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method|Assessed at baseline and after 24 weeks of treatment||||ug/L||Standard Deviation|Mean
2788515|NCT00605267|Secondary|Bone Turnover Marker (BAP) EIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method|Assessed at baseline and after 24 weeks of treatment||||U/L||Standard Deviation|Mean
2788516|NCT00605267|Secondary|Bone Mineral Density (BMD) Cervical Thighbone|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.|Assessed at baseline and after 24 weeks of treatment|Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks – BMD percentage at baseline|||PercentageBMD=Patient'sBMD/standard BMD)||Standard Deviation|Mean
2788517|NCT00605267|Secondary|Bone Mineral Density (BMD) Lumbar Spine|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.|Assessed at baseline and after 24 weeks of treatment|The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100|||PercentageBMD=Patient's BMD/standard BMD||Standard Deviation|Mean
2788518|NCT00605267|Primary|Best Overall Response Rate (BORR) (MRI/CT)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).~CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks||||Percentage of Participants|||Number
2788519|NCT00605267|Primary|Best Overall Response Rate (BORR) (US)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks||||Participants|||Number
2788520|NCT00605267|Primary|Best Overall Response Rate (BORR) (Calliper)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period.~At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"|||Percentage of Participants|||Number
2788521|NCT00605202|Primary|Plasma Potassium|Plasma potassium measured with indirect ion specific electrode method|Baseline and 2 weeks||||mmol/l||Standard Deviation|Mean
2788549|NCT00604890|Secondary|Number of Participants With Partial Response|To determine the number of participants with a partial response, defined as a clinically significant decrease (ie, at least 50%) in the area of the sBCC lesion, computed as the product of the two principal diameters at Week 10 (4 weeks post-treatment)|10 weeks||||Participants|||Count of Participants
2788522|NCT00605189|Primary|Compare Energy Charge Between Wound Treatment Therapies|"Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit.~Energy Charge is calculated as follows:~Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP)~Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate"|Day 0, Day 2, Day 7|Energy charge data was not available for all subjects on the study. Data was only recorded for the subjects listed above.|||Ratio||Standard Deviation|Mean
2788523|NCT00605176|Secondary|Local Skin Reactions|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)|At all visits - from Baseline to End of study (Week 14)|All participants were evaluated for local skin reactions (LSR) at every visit. Summary of LSR - area under the curve (AUC) of sum of LSR Scores (days). ITT population. The time period for the AUC extends to 8 weeks after the end of treatment (Week 14). Only subjects who received treatment in both treatment cycles are included in this analysis.|||units on a scale * days||Standard Deviation|Mean
2788524|NCT00605176|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions.|From baseline to End of Study the Week 14 visit|Intent to treat (ITT) Last Observation Carried Forward (LOCF)|||percent change||Full Range|Median
2788525|NCT00605176|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).|||participants|||Number
2788526|NCT00605176|Primary|Number of Participants With Complete Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or 'subclinical' lesion that had not been identified at Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF, primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).|||participants|||Number
2788527|NCT00605150|Secondary|Number of Participants With Unacceptable Side Effects After Treatment||6 months||||Participants|||Count of Participants
2788528|NCT00605150|Primary|Progression|Progression of liver cancer|6 months|Number of participants enrolled|||participants|||Number
2788529|NCT00605085|Secondary|SCR and GMT of Subjects With Concomitant Vaccinations||until Day 56|||||||
2788530|NCT00605085|Secondary|Changes in Laboratory Parameters||until Day 56|||||||
2788531|NCT00605085|Secondary|Rates of Serious Adverse Events and Medically Attended Adverse Events||until Day 56|||||||
2788532|NCT00605085|Primary|Safety and Tolerability up to Day 56|calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)|Day 56|Safety Population|||percentage of participants with AEs|||Number
2788533|NCT00605072|Primary|Cognitive Assessment: Forward Digit Span Test|This test consists of series of digits of increasing length, some of which are recited as presented, and some of which are to be recited in reversed order. The forward digit span score ranges from 0 (ie cannot repeat two digits) to 8 ( participant can repeat up to 8 digits)|Baseline-12 months||||number of digits repeated||Standard Error|Least Squares Mean
2788534|NCT00605072|Primary|Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall|This is a 12-item list learning test in which individuals are presented three learning and recall trials followed by a delayed recall and 24 item recognition test. The HVLT-R has been identified as an ideal memory measure for elderly patients, and appropriate reliability and validity have been shown in older individuals. The test score is the number of correct answers in the delayed recall ( score range 0-12)|Baseline-12 months||||number words remembered||Standard Error|Least Squares Mean
2788535|NCT00605072|Secondary|Blood Flow Velocity, Sitting|This reports the change in the least square mean from baseline to 12 months, adjusted for age|Baseline-12 months||||cm/sec||Standard Error|Least Squares Mean
2788536|NCT00605072|Secondary|Blood Pressure Outcome: Systolic BP|Blood pressure was measured as follows: the participant was in the sitting position, rested for 5 minutes, no caffeine or smoking 2 hours prior to measurement, using appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference), correct cuff placement (1-2 inches above brachial pulse on bare arm), and the bell of the stethoscope. The systolic blood pressure was defined as the pressure corresponding to the first korotkoff sounds (K1) and the diastolic as the pressure corresponding to the last korotkoff sound (K5). Blood pressure was measured in both arms and recorded|Baseline-12 months||||mm Hg||Standard Error|Least Squares Mean
2788537|NCT00605072|Primary|Cognitive Assessment: Trail Making Test Part B|This test requires the connection of sequentially numbered circles (A), and the connection of circles marked by numbers and letters in alternating sequence (B). This test is considered a benchmark of executive function. The test score is the time required to complete the task in seconds.|Baseline-12 months||||seconds||Standard Error|Least Squares Mean
2788538|NCT00605033|Primary|Response Rate|Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.|Assessed by Day 7 of double-blind, double-dummy treatment period.|Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.|||Percentage of participants|||Number
2788539|NCT00604968|Secondary|Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment|The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).|Of the 25 total patients, 12 were hospitalized during the study.|||days|||Number
2788540|NCT00604968|Secondary|Duration of Overall Survival|Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival.|Time of treatment until death, up to the time that all participants ended treatment||||months||95% Confidence Interval|Median
2788541|NCT00604968|Secondary|Time to Progression|"Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria):~Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease.~Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions."|Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Of the 25 patients in the study 3 patients had non-measurable disease and could not be included in the progression analysis.|||months||95% Confidence Interval|Median
2788542|NCT00604968|Secondary|Duration of Response|"Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study.~Response can be partial or complete (as previously defined), whichever status is recorded first."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Three patients showed Partial Response according to RECIST criteria.|||weeks||Full Range|Median
2788543|NCT00604968|Secondary|Time to Response|Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first.|Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Only 3 patients had measureable time to response|||Weeks||Full Range|Median
2788544|NCT00604968|Secondary|Number of Patients Requiring Dose Reduction|The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).||||participants|||Number
2788545|NCT00604968|Secondary|Number of Patients With Progressive Disease (PD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions~WHO PD criteria required increase in size of existing lesions or appearance of new lesions."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.|||participants|||Number
2788546|NCT00604968|Secondary|Number of Patients With Partial Response (PR) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions~WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks"|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.|||participants|||Number
2788547|NCT00604968|Secondary|Number of Patients With Stable Disease (SD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions.~WHO response criteria for SD required no significant change for at least 8 weeks."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.|||participants|||Number
2788548|NCT00604968|Primary|Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).|Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.|Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).||||Months||95% Confidence Interval|Median
2790108|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2788551|NCT00604825|Secondary|Change From Baseline at Week 12 in Abdomen Visceral Adipose Tissue (AVAT), Abdomen Subcutaneous Adipose Tissue (ASAT), Thigh Subcutaneous Adipose Tissue (TSAT) and Thigh Intermuscular Adipose Tissue (TIAT)|AVAT, ASAT, TSAT and TIAT was measured in centimeter to once decimal place by CT scan. A CT scan of the abdomen was conducted at the Lumbar 4 vertebrae level. A CT scan of the right thigh was performed at half the distance between the knee joint and greater trochanter femoralis. Scans were performed with 120 kilovolts, 5 millimeter slice thickness (thigh scan 3 millimeter slice thickness) and 48 centimeter scan field of view. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Body Composition Population. Only those participants available at the specified time points were analyzed.|||Square centimeters||Standard Deviation|Mean
2788552|NCT00604825|Secondary|Change From Baseline at Week 12 in Abdomen Body Circumference, Abdomen Saggital Diameter and Thigh Circumference|Thigh circumference was measured on the left leg directly below the gluteal fold; with the participant standing with both arms at the side, feet together, and with equal weight on both feet when this measurement was taken. The thigh was measured at least twice until two measurements were within 1 centimeter, and the last reading recorded. Abdomen body circumference and abdomen saggital diameter was measured in centimeter to once decimal place by Computerized tomography (CT) scan with the participant in supine position. CT scan of the abdomen was conducted at the Lumbar 4 vertebrae level. Scans were performed with 120 kilovolts, 5 millimeter slice thickness and 48 centimeter scan field of view. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Body Composition Population which comprised of any ITT participants who provided consent for the body composition sub-study and received additional body composition assessments. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
2788553|NCT00604825|Secondary|Change From Baseline at Week 12 in Body Mass Index (BMI)|BMI was calculated from height (taken at Screening Visit 1 [Day -35]) and weight at Week 12 using the formula: BMI = [weight in kilograms divided by (height in meters)^2]. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Kilogram per square meters||Standard Error|Least Squares Mean
2788554|NCT00604825|Secondary|Change From Baseline at Week 12 in Weight|Participants were weighed on a calibrated balance beam or digital scale. Participants were instructed to be dressed in light indoor clothing without shoes and also to have empty pockets and to void before weighing. It was strongly recommended that participants were weighed in the morning at the beginning of the clinic visit. Weight was measured at least twice or more if necessary, until two measurements were within 0.5 kilograms. The last (confirmed) reading was recorded in the electronic case report form. Weight was recorded in kilograms to the nearest tenth. When the weight was measured in pounds, it was converted into kilograms using the conversion factor: pounds/ 2.2 = kilograms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
2788555|NCT00604825|Secondary|Change From Baseline at Week 12 in Hip Circumference|For hip circumference, the participant was instructed to stand erect with arms at sides and feet together. The measurement was taken at the point yielding the maximum circumference over the buttocks (widest part of the greater trochanters) with nonstretchable tape. The tape was even, not twisted with the measurement scale facing outward. The assessor was instructed to ensure that the tape was just touching the skin but not compressing the soft tissue. The hip should be measured at least twice until two measurements are within 1 centimeter and the last reading recorded. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Error|Least Squares Mean
2788556|NCT00604825|Secondary|Change From Baseline at Week 12 in Waist Circumference|To measure waist circumference, clothing was lifted from around the waist to ensure correct positioning of the measuring tape. Participants were instructed to stand erect with abdomen relaxed, arms at side, feet together, and weight equally divided over both legs. The non-stretchable tape was placed at the waist midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. The tape was even, parallel to the floor not twisted with the measurement scale facing outward. The assessor was instructed to ensure that the tape was just touching the skin but not compressing the soft tissue. The measurement was made at the end of a normal expiration. The waist was measured at least twice or more if necessary, until two measurements were within 1 centimeter and the confirmatory reading recorded to one decimal place. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Error|Least Squares Mean
2788557|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Testosterone|Serum hormones included testosterone. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline at Week 12 in testosterone are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Nanomol per Liter||Standard Deviation|Mean
2788558|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Serum hormones included FSH and LH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||International units per Liter||Standard Deviation|Mean
2788559|NCT00604825|Secondary|Change From Baseline at Week 12 in Serum Hormone Levels- Estradiol|Serum hormone included Estradiol. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline at Week 12 in estradiol are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Picomoles per Liter||Standard Deviation|Mean
2790109|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2788560|NCT00604825|Secondary|Change From Baseline in Glucose at Week 12|Pharmacodynamic marker included glucose. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Deviation|Mean
2788561|NCT00604825|Secondary|Change From Visit 2 to Visit 8 in Percentage of Superficial Cells to Determine the Vaginal Maturation Index (VMI)|"A lateral vaginal wall specimen was collected at Visit 2 (Day -21) and Visit 8 (Week 12) and was sent to Central Pathology for analysis. Parabasal, intermediate, and superficial squamous cells were counted and percentages calculated. The VMI (also referred to as Maturation Value [MV]) of the vaginal mucosa was calculated according to the following equation:~VMI (MV)= (% Intermediate Cells x 0.5) + (% Superficial cells). Visit 2 was Day -21 and Visit 8 was Week 12. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values."|Visit 2 (Day -21) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of cells||Standard Error|Least Squares Mean
2788562|NCT00604825|Secondary|Change From Visit 2 to Visit 8 in Vaginal pH|Vaginal pH was measured at Visit 2 and Visit 8 using standard pH indicator strips available at the participating site clinic. The pH indicator strip was inserted to the upper portion of the proximal one third of the vaginal vault, placed in contact with the lateral vaginal mucosal wall for approximately 1 minute, and evaluated according to the instructions provided in the package labeling. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the vagina and higher the number, more alkaline the vagina with 7 being neutral. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values.|Visit 2 (Day -21) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.|||Points on a scale||Standard Error|Least Squares Mean
2788563|NCT00604825|Secondary|Change in Work Productivity and Activity Impairment (WPAI) Score From Visit 2 to Visit 7|The WPAI is a questionnaire that measured workplace productivity and absenteeism via 6 items/questions, adapted to participants experiencing menopausal symptoms. Item 1 asks about current employment with a yes/no response. Items 2- 4 ask for continuous response in hours. Item 5 asks for response on rating scale related to WP ranging from 0:Menopausal symptoms had no effect on work to 10:Couldn't work at all. Item 6 asks for response on rating scale related to daily activities ranging from 0:no effect on daily activities to 10:Couldn't perform any daily activities. The score calculation- Effect on work: (Item 5 score÷10); Absenteeism: (Item 2÷Item 2+Item 4); Overall work impairment ([Item 2÷Item 2+Item 4]+ [1- {Item 2÷Item 2+Item 4}]*[ Item 5 score÷10]); Activity impairment: (Item 6 score÷10). Total score range from 0 to 10 where higher score indicates worst condition. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788564|NCT00604825|Secondary|Change in the Centers for Epidemiologic Studies in Depression (CES-D) Score From Visit 2 to Visit 7|The CES-D is a questionnaire designed to measure depressive symptoms via 20 items that are summed to create a total score. Depressive symptoms are fairly common in postmenopausal women, and it's possible that stimulation of estrogen receptors via a selective estrogen receptor modulator may improve depressive symptoms. Questions 4, 8, 12 and 16 are weighted negatively (the scores are flipped prior to creating total score). If 3 or more items are missing then total score is missing. If fewer than 3 items are missing then missing item is set to group mean of that item for appropriate randomized treatment group. These means are only calculated if more than half of the participants used for calculation have responded to item. The items are summed to give total score ranging from 0 to 60. Lower score 0=no depression, higher score 60=higher degree of depression severity. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788565|NCT00604825|Secondary|Change in Brief Fatigue Inventory (BFI) Score From Visit 2 to Visit 7|The BFI is a validated questionnaire designed to measure a participant's fatigue via nine questions that are summated to create a total score. Items 1-3 request a rating on a scale ranging from 0 - 10 with 0 representing 'No Fatigue' and 10 representing 'As bad as you can imagine'. Five items 4A-4F request an interference score on a scale ranging from 0 - 10 with 0 representing 'Does not interfere' and 10 representing 'Completely Interferes'. The values of the scales for all items was used in scoring the response to each item. The following groupings of items was used to create domain scores. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher score indicates more severe fatigue. Visit 2 was Day -21. Change from Visit 2 was calculated by subtracting Visit 2 values from post-Visit 2 values.|Visit 2 (Day -21) to Visit 7 (Week 8)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788566|NCT00604825|Secondary|Changes in Vulvar Vaginal Atrophy (VVA) Symptom Score From Baseline to Visit 8 (Week 12)|The VVA Symptoms Scale questionnaire is an 18-item instrument that captures symptoms related to VVA, asks participant to identify symptom that bothers them the most and contains items to assess degree of bother participants experience from each symptom and impact that most bothersome symptom has on their daily life. Items 1 to 8 had responses and scores of none=0, mild=1, moderate=2 and severe=3. Items 9 to 18 had responses and scores of not at all=0, a little=1, moderately=2 and a lot=3. Severity item and bothersome item respectively were as follows: vaginal dryness:1 and 9; Vaginal itching:2 and 10; Vaginal irritation:3 and 11; Painful urination:4 and 12; Difficulty urinating:5 and 13; Vaginal pain associated with sexual activity:6 and 14; Vaginal bleeding associated with sexual activity:7 and 15. Total score ranged from 0 to 3; higher score indicated most bothersome. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Visit 8 (Week 12)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2788574|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at Week 12|Clinical chemistry parameters included ALT, ALP and AST. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Units per Liter||Standard Deviation|Mean
2788567|NCT00604825|Secondary|Change in Medical Outcomes Study (MOS) Sleep Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)|The MOS Sleep Scale is a validated questionnaire designed to measure a participant sleep quality via 12 questions. Items are designed to be grouped into domains that include sleep disturbance (items 1, 3, 7, 8), sleep adequacy (items 4, 12), daytime somnolence (items 6, 9, 11), sleep quantity (2), 6-Item Sleep Scale (items 4, 5, 7, 8, 9, 12) and 9-Item Sleep Scale (items 3, 4, 5, 6, 7, 8, 9, 11, 12). Each domain is given a separate score. The domain score is calculated as the sum of the individual item scores in that domain. Transformed scores were calculated for the domains only. This transformation converts the raw domain score to a 0 to 100 scale following the formula: Transformed score = ([Raw score - Lowest possible score]/Possible score range)*100. Lowest score 0 indicates best sleep quality and higher score 100 indicates worst sleep quality. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788568|NCT00604825|Secondary|Change in Menopause Quality of Life (MENQoL) Score From Baseline to Visits 6 (Week 4) and Visit 8 (Week 12)|MENQOL instrument is a 32-item, validated questionnaire designed to measure symptoms that participants experience due to menopause and degree to which these symptoms bother them. Each item references a symptom and is composed of two-part question; a yes/no confirmation that the participant has symptom followed by a question asking how bothersome the symptom is, if present. The MENQOL items are designed to be grouped into domains that address vasomotor (items 1-3), psychosocial(items 4-10), physical (items 11-26, 30-32) and sexual symptoms (items 27-29). Each domain is given a separate score; there is no overall score. The domain score is sum of individual item scores divided by number of items in that domain. Since domain subscales are not comprised of an equivalent number of items, mean of subscale is used as overall subscale score. Each domain score ranges from 1 to 8. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788569|NCT00604825|Secondary|Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Severity at Week 12 of at Least 50%, at Least 75%, and 100%|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. The VMS severity was as follows: mild (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate (heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe (intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). The severity of VMS events were calculated using self-reported participants assessments recorded and transmitted by eDiary. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent change was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2788570|NCT00604825|Secondary|Number of Participants With VMS Percent Change From Baseline Responders With a Reduction in Frequency at Week 12 of at Least 50%, at Least 75%, and 100%|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change question. The severity of VMS events were calculated using self-reported participants assessments recorded and transmitted by eDiary. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent change was calculated by multiplying the change from baseline value with 100. Number of participants with VMS percent change from Baseline responders with a reduction in frequency at Week 12 of at least 50%, at least 75%, and 100% are presented.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2788571|NCT00604825|Secondary|Mean Change in Severity of VMS From Baseline to Weeks 4 and 8|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. The VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 8|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788572|NCT00604825|Secondary|Mean Change in Frequency of VMS From Baseline to Weeks 4 and 8|"Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using as Global Change Question. The frequency was assessed using the question 1 as Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?. the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values."|Baseline (Week 0) to Week 8|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788573|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (C02) Content, Chloride, Phosphorous, Inorganic, Potassium, Sodium and Urea at Week 12|Clinical chemistry parameters included calcium, C02 content, chloride, phosphorous, inorganic, potassium, sodium and urea. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimol per Liter||Standard Deviation|Mean
2788575|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Creatinine, Direct Bilirubin, Total Bilirubin and Uric Acid at Week 12|Clinical chemistry parameters included creatinine, direct bilirubin, total bilirubin and uric acid. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromoles per Liter||Standard Deviation|Mean
2788576|NCT00604825|Primary|Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein at Week 12|Clinical chemistry parameters included albumin and total protein. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
2788577|NCT00604825|Primary|Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils and White Blood Cell (WBC) Count at Week 12|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils and WBC count are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gigacells per Liter||Standard Deviation|Mean
2788578|NCT00604825|Primary|Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Week 12|Hematology parameters included Hemoglobin and MCHC. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
2788579|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Red Blood Cell (RBC) Count at Week 12|Hematology parameter included RBC count. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Trillion cells per Liter||Standard Deviation|Mean
2788580|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Mean Corpuscle Volume (MCV) at Week 12|Hematology parameter included MCV. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
2788581|NCT00604825|Primary|Change From Baseline in Hematology Parameter- Mean Corpuscle Hemoglobin (MCH) at Week 12|Hematology parameter included MCH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
2788582|NCT00604825|Primary|Change From Baseline and Week 12 in Hematology Parameter- Hematocrit at Week 12|Hematology parameter included hematocrit. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
2788583|NCT00604825|Primary|Change From Baseline and Week 12 in Inflammatory Marker- Endothelin-1 at Week 12|Inflammatory marker included Endothelin-1. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Nanogram per Liter||Standard Deviation|Mean
2788584|NCT00604825|Primary|Change From Baseline and Week 12 in Inflammatory Marker- High Sensitivity C-reactive Protein (Hs-CRP) at Week 12|Inflammatory marker included hs-CRP. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Milligram per Liter||Standard Deviation|Mean
2788585|NCT00604825|Primary|Change From Baseline in Thrombotic Marker- Tissue Plasminogen Activator (tPA) Antigen at Week 12|Thrombotic marker included tPA antigen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Microgram per Liter||Standard Deviation|Mean
2788586|NCT00604825|Primary|Change From Baseline in Thrombotic Marker- Fibrinogen at Week 12|Thrombotic marker included fibrinogen. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per LIter||Standard Deviation|Mean
2788587|NCT00604825|Primary|Mean Change in Severity of VMS From Baseline at Week 12|Individual VMS (hot flash or night sweats) events were recorded by participants in an eDiary using global change questions. VMS severity was as follows: mild=score of 1 (brief wave of heat with minimal discomfort, usually without perspiration; able to continue activity [or sleep]), moderate=score of 2(heat with some discomfort, usually with perspiration; minimal interruption of activity [or sleep]), severe=score of 3(intense heat with considerable discomfort, usually with heavy sweating; may be unable to resume activity [or sleep] right away) and extremely severe=score of 4 (unbearable heat with intense discomfort, usually with pouring sweat; may be unable to resume activity [or sleep] for quite a while). Total score ranged from 1 to 4 and is the sum of severity scores divided by total number of VMS events. Higher score indicates worst condition. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12|ITT Population with LOCF analysis. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2788613|NCT00604708|Primary|SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56|SCR: anti-JEV neutralizing antibody titer ≥1:10|Day 56|Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan|||percentage of participants|||Number
2788588|NCT00604825|Primary|Mean Change in Frequency of Vasomotor Symptoms (VMS) From Baseline at Week 12|"Individual VMS (hot flash or night sweats) events were recorded by participants in an electronic diary (eDiary) using as Global Change Question. The frequency was assessed using the question 1 as Since you started the study medication, how has the number of your hot flashes (including night sweats) changed?. the response was rated on a 7-point scale from +3 to -3, where +3=A great deal better, +2=Moderately better, +1=A little better, 0=No change, -1=A little worse, -2=Moderately worse and -3=A great deal worse. The score ranged from +3 to -3, where +3 implied absence of symptoms and lower score implied more severe symptoms. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Adjusted mean is presented as least square mean."|Baseline (Week 0) and Week 12|Intent-to-Treat Population (ITT) Population which comprised of all randomized participants. Last Observation Carried Forward (LOCF) was the imputation technique used.|||Scores on a Scale||Standard Error|Least Squares Mean
2788589|NCT00604825|Primary|Occurrence of Withdrawal Bleeding-number of Days of Spotting, Number of Days of Bleeding, Number of Days of Spotting/Bleeding Combined|After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg MPA) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting, bleeding and also spotting/bleeding combined is presented.|Up to Follow-up (Day 112)|Uterine Safety Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2788590|NCT00604825|Primary|Occurrence of Withdrawal Bleeding-duration of Spotting/Bleeding|After completion of the 12-week treatment period, participants with an intact uterus received a 14-day cycle of progestogen (10 mg medroxyprogesterone acetate [MPA]) to induce withdrawal bleeding. All participants were required to return to clinic for Follow-Up Visit. Participants were asked to record occurrence of bleeding/spotting each day, from the day MPA dosing began until Follow-up using the following criteria: None (no bleeding or spotting), Spotting: any vaginal flow requiring not more than one sanitary napkin or tampon per day (lightly stained and not soaked through) and Bleeding: any vaginal flow requiring more than one sanitary napkin or tampon per day. The following information was recorded in electronic case report form: start and stop date of MPA administration as well as dates of any spotting/bleeding. Duration of spotting or bleeding is presented.|Up to Follow-up (Day 112)|Uterine Safety Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2788591|NCT00604825|Primary|Endometrial Biopsy Pathology|Endometrial biopsies were conducted at Baseline and end-of-treatment (end-of-treatment values were defined as the last available post-Baseline values before treatment was stopped) for all study participants with an intact uterus. These procedures were performed by an experienced physician. Each biopsy was obtained after the TVUS was performed. Proliferative endometrium also meant hyperplasia without atypia (normal).|Baseline (Week 0) to Week 12|Uterine safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2788592|NCT00604825|Primary|Change From Baseline in Bi-layer Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS) or Saline Infusion Sonohysterography (SIS)|All participants with an intact uterus participating in this study underwent a TVUS at Baseline and at Week 12, to investigate the cause of any abnormal uterine bleeding during the study. In the event the TVUS was not well visualized or there were abnormal findings at either visit, or the bi-layer thickness exceeded 5 millimeter at Week 12, a SIS was conducted to visualize the anterior and posterior walls. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline and Week 12 in heart rate are presented.|Baseline (Week 0) to Week 12|Uterine Safety Population which comprised of all randomized participants who had a uterus and also received at least one dose of investigational product. Only those participants available at the specified time points were analyzed.|||Millimeter||Standard Deviation|Mean
2788593|NCT00604825|Primary|Change From Baseline in Fasting Lipid Profile at Week 12|Fasting lipids included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholestereol direct and triglycerides. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in fasting lipid profile at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole per Liter||Standard Deviation|Mean
2788594|NCT00604825|Primary|Change From Baseline in Thyroxine (T4) and Insulin at Week 12|Serum hormone markers included T4 and additional pharmacodynamics marker included insulin. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in T4 and insulin at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Picomole per Liter||Standard Deviation|Mean
2788595|NCT00604825|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) at Week 12|Serum hormone markers included TSH. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in TSH at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliunits/Liter||Standard Deviation|Mean
2788596|NCT00604825|Primary|Change From Baseline in Vital Sign of Heart Rate at Week 12|Heart rate was measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in heart rate at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2788614|NCT00604695|Secondary|Safety Endpoint: Number of Deaths||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
2788597|NCT00604825|Primary|Change From Baseline in Vital Signs of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12|SBP and DBP were measured after the participant had rested for at least 5 minutes in a sitting or supine position. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in SBP and DBP at Week 12 are presented.|Baseline (Week 0) and Week 12|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2788598|NCT00604825|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) and Number of Participants With Mild, Moderate and Severe AE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The severity of AEs was assessed by the investigator as mild, moderate or severe.|Up to 21 weeks|Safety Population which comprised of all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2788599|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)|Preliminary pharmacokinetics data; Apparent half-life (t½)|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||Hours||Standard Deviation|Mean
2788600|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)|Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||Hours||Full Range|Median
2788601|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)|Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||ng/mL||Standard Deviation|Mean
2788602|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))|Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.|||ng hr/mL||Standard Deviation|Mean
2788603|NCT00604812|Primary|Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)|24 Hours|All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability.|||Participants|||Number
2788604|NCT00604786|Primary|Change in Basophil Surface IgE|"Flow cytometry in mean fluorescence units.~100%*[(3.5 month value minus baseline value)/baseline value]"|Change from baseline to 3.5 months|2 participants on the Omalizumab subcutaneous group moved and were therefore lost to follow-up.|||percentage of basophil surface IgE||Standard Deviation|Mean
2788605|NCT00604721|Secondary|Median Overall Survival (OS)|Overall survival has been defined as time from the start of treatment to death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy|||months||95% Confidence Interval|Median
2788606|NCT00604721|Secondary|Median Progression Free Survival (PFS)|Progression free survival has been defined as time from the start of treatment to disease progression or death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy|||months||95% Confidence Interval|Median
2788607|NCT00604721|Primary|Number of Participants With Radiographic Objective Response (OR)|"To ascertain the objective response rate (Complete Response + Partial Response [CR+PR]) of patients with the single-agent AZD6244. Our study utilized Response Evaluation Criteria in Solid Tumors (RECIST) to evaluate response.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|33 weeks|Participants who completed a full 21 day cycle of therapy|||participants|||Number
2788608|NCT00604708|Primary|GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56|GMT: geometric mean of PRNT50|Day 56|PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded.|||titers||Standard Deviation|Geometric Mean
2788609|NCT00604708|Secondary|Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age||Day 56|||||||
2788610|NCT00604708|Secondary|Immunogenicity at Day 56 for North America vs. Europe||Day 56|||||||
2788611|NCT00604708|Secondary|Immunogenicity at Day 28||Day 28|||||||
2788612|NCT00604708|Secondary|Safety and Adverse Events||until Day 56|||||||
2788616|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
2788617|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding||Through 30days following PPCI|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)|||participants|||Number
2788618|NCT00604695|Secondary|Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients|||participants|||Number
2788619|NCT00604695|Secondary|Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients|||Corrected TIMI Frame Count (cTFC)||Inter-Quartile Range|Median
2788620|NCT00604695|Secondary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."|||participants|||Number
2788621|NCT00604695|Secondary|Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."|||participants|||Number
2788622|NCT00604695|Primary|Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."|||Percent diameter stenosis||Inter-Quartile Range|Median
2788623|NCT00604669|Primary|Mortality|Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.|at the end of the chart review of all patients||||mortality rate|||Number
2788624|NCT00604565|Primary|TOTAL NUMBER OF ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.|||events|||Number
2788625|NCT00604565|Primary|TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.|||participants|||Number
2788626|NCT00604552|Secondary|Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events||5 years|Study terminated before subjects met study 5 year endpoints. FDA agreed to closure of study prior to reaching the 5 year endpoint.||||||
2788627|NCT00604552|Primary|Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion|Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion|5 year|All those treated on-label for the treatment of an AAA and followed out to 5 years.|||participants|||Number
2788628|NCT00604500|Primary|End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)|The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.|4-week Treatment Period|Completer Population, excluding 2 participants who used more than the labeled number of actuations.|||Number of inhalers|||Number
2788668|NCT00604175|Secondary|Number of Participants With Signs and Symptoms of Grade 3 or Higher|Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.|||Participants|||Number
2788629|NCT00604500|Primary|Overall Discrepancy Size|Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.|||Discrepancy Size Per 100 actuations|||Number
2788630|NCT00604500|Primary|Overall Quartile Discrepancy Rate|"Quartile discrepancies refer to the difference between~the participant-recorded number of actuations and the participant-recorded~counter readout at each of the 4 weekly visit intervals [ie, quartiles] to~evaluate whether there was any difference in agreement over the life of~the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population."|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.|||discrepancies per 100 actuations|||Number
2788631|NCT00604500|Primary|Overall Discrepancy Rate|Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).|4-week Treatment Period|Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.|||Overall discrepancies per 100 actuations|||Number
2788632|NCT00604461|Secondary|Number of Months of Progression Free Survival (PFS)|The PFS is defined as the duration of time from the start of treatment to time of progression or death, whichever occurs first.|2 Years, 9 Months|All participants|||Months||95% Confidence Interval|Median
2788633|NCT00604461|Primary|Number of Participants With Partial Response (PR) of Target Lesions|Tumor response was assessed in 12 patients who had at least one follow-up computed tomography (CT) scan. Response Evaluation Criteria in Solid Tumors (RECIST) definition of Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 12 Months|All participants with baseline and at least one post-baseline target lesion measurement.|||participants|||Number
2788634|NCT00604383|Secondary|Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.|Baseline, up to 36 months|All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values|||units on a scale||Standard Deviation|Mean
2788635|NCT00604383|Secondary|Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)|NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).|Baseline, up to 36 months|All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
2788636|NCT00604383|Secondary|Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)|Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.|||percentage of participants|||Number
2788637|NCT00604383|Secondary|Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)|DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100.|Baseline through 36 months|All randomized participants who had no center involved or imminently threatened DME at baseline.|||percentage of participants|||Number
2788638|NCT00604383|Primary|Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period|SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.|||percentage of participants|||Number
2788639|NCT00604279|Secondary|Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal|A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.|Day 92 or early withdrawal|Per Protocol Analysis Set.|||Percentage of participants|||Number
2788640|NCT00604279|Secondary|Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal|The self-administered sleep VAS scale (0-100 millimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set.|||millimeter (mm)||Standard Deviation|Mean
2788641|NCT00604279|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."|||Units on scale||Standard Deviation|Mean
2788642|NCT00604279|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal|This PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; <= 30, functioning so poorly as to require intensive supervision.|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."|||Units on scale||Standard Deviation|Mean
2788643|NCT00604279|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations.|||Units on scale||Standard Deviation|Mean
2788644|NCT00604214|Secondary|Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint||Baseline through Day 28|Participants who received study drug.|||percentage of participants|||Number
2788645|NCT00604214|Other Pre-specified|Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28|Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.|Baseline through Day 28|Participants who received study drug.|||percentage of participants|||Number
2788646|NCT00604214|Secondary|Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180|SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.|Baseline and Days 28 and 90 and 180|All randomized participants with SF-12 score data at the specified time points.|||units on a scale||Standard Deviation|Median
2788647|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180|The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D total score data at the specified time points.|||units on a scale||Standard Deviation|Mean
2788648|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180|EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D VAS data at the specified time points.|||units on a scale||Standard Deviation|Mean
2788649|NCT00604214|Secondary|Median Survival Time||Day 180|All randomized participants excluding those with unknown mortality status at Day 180.|||days||Full Range|Median
2788650|NCT00604214|Secondary|180-Day Mortality|Expressed as percentage of participants who died from any cause at Day 180 endpoint.|Day 180|All randomized participants with known mortality status at Day 180.|||percentage of participants|||Number
2788651|NCT00604214|Secondary|90-Day Mortality|Expressed as percentage of participants who died from any cause at Day 90 endpoint.|Day 90|All randomized participants with known mortality status at Day 90.|||percentage of participants|||Number
2788652|NCT00604214|Secondary|Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|||units on a scale||Standard Deviation|Mean
2788653|NCT00604214|Secondary|Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|||units on a scale||Standard Deviation|Mean
2789663|NCT00596622|Secondary|Young Mania Rating Scale|Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; >20 severe mania|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2788654|NCT00604214|Secondary|Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|||units on a scale||Standard Deviation|Mean
2788655|NCT00604214|Secondary|28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency|Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).|Day 28|All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.|||percentage of participants|||Number
2788656|NCT00604214|Primary|28-Day All-Cause Mortality|Expressed as percentage of participants who died from any cause at Day 28 endpoint.|Day 28|All randomized participants with known mortality status at Day 28.|||percentage of participants|||Number
2788657|NCT00604188|Secondary|Responders at Day 28|Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.|28 days|ITT population|||Participants|||Number
2788658|NCT00604188|Secondary|Compliance Rate|Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.|28 days|ITT population|||Percentage of days||Standard Deviation|Mean
2788659|NCT00604188|Secondary|Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric|"The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28.~The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis."|Baseline and 28 days|ITT population.|||Score on a scale||Standard Error|Least Squares Mean
2788660|NCT00604188|Secondary|Observer-rated Opioid Withdrawal Symptoms (OOWS)|The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with OOWS data reviewed for completeness and within visit date consistency were analyzed.|||Score on a scale||Standard Deviation|Mean
2788661|NCT00604188|Secondary|Self-reported Opioid Withdrawal Symptoms (SOWS)|SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with SOWS data reviewed for completeness and within visit date consistency were analyzed.|||Score on a scale||Standard Deviation|Mean
2788662|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)|Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.|Days 3 to 28|ITT population|||Participants|||Number
2788663|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)|Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.|28 days|Participants with missing data were not included in the analysis.|||Participants|||Number
2788664|NCT00604188|Primary|Responders at Day 3|"Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders.~All participants that continued the study received Suboxone tablets on Day 3."|3 days|ITT population|||Participants|||Number
2788665|NCT00604175|Secondary|Change in CD4 Cell Count From Baseline|A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline.|Weeks 0, 4, 8, 12, 24, 28, 52 and 72|N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88.|||Cells/mm^3||Inter-Quartile Range|Median
2788666|NCT00604175|Secondary|Change in Log10 HIV Viral Load (VL) From Baseline|A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline.|Weeks 0, 4, 12, 28, 52, and 72|N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83.|||Log10 copies/mL||Inter-Quartile Range|Median
2788667|NCT00604175|Secondary|Number of Participants With Laboratory Abnormalities of Grade 3 or Higher|Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.|||Participants|||Number
2788669|NCT00604175|Secondary|Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline|Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19.|||Log10 mMU/mL||Inter-Quartile Range|Median
2788670|NCT00604175|Secondary|Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline|Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24.|||Log10 mMU/mL||Inter-Quartile Range|Median
2788671|NCT00604175|Secondary|Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline|Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19.|||Log10 mMU/mL||Inter-Quartile Range|Median
2788672|NCT00604175|Secondary|Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline|Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35.|||Log10 mMU/mL||Inter-Quartile Range|Median
2788673|NCT00604175|Secondary|HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline|HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69.|||mMU/mL||95% Confidence Interval|Geometric Mean
2788674|NCT00604175|Secondary|HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline|HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64.|||mMU/mL||95% Confidence Interval|Geometric Mean
2788675|NCT00604175|Secondary|HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline|HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69.|||mMU/mL||95% Confidence Interval|Geometric Mean
2788676|NCT00604175|Secondary|HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline|HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53.|||mMU/mL||95% Confidence Interval|Geometric Mean
2788744|NCT00603746|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1||Standard Deviation|Mean
2788677|NCT00604175|Primary|Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
2788678|NCT00604175|Primary|Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
2788679|NCT00604175|Primary|Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
2788680|NCT00604175|Primary|Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28.|||Percentage of participants||95% Confidence Interval|Number
2788681|NCT00604162|Primary|Specificity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.|||Percentage of Participants||95% Confidence Interval|Number
2788682|NCT00604162|Secondary|Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)||within 7 days|||||||
2788683|NCT00604162|Primary|Sensitivity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.|||Percentage of Participants||95% Confidence Interval|Number
2788684|NCT00604162|Primary|Number of Participants With Indicated Lesions Detected by Standard Colonoscopy|"Since the standard colonoscopy is the gold standard to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger."|1 day|Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy.|||participants|||Number
2788685|NCT00604162|Secondary|Percentage of Excreted Colon Capsules||Within 7 days|||||||
2788686|NCT00604162|Secondary|Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy||within 7 days|||||||
2788687|NCT00604162|Secondary|Number, Type and Severity of Adverse Events||Within 7 days|||||||
2788688|NCT00604162|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:~poor cleansing level (Large amount of fecal residue.)~fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)~good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)~excellent cleansing level (No more than small bits of adherent feces.)"|1 day||||Percentage of Participants||95% Confidence Interval|Number
2788689|NCT00604162|Primary|Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies|The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.|1 day||||participants|||Number
2788690|NCT00604045|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)||||units on a scale||Standard Deviation|Mean
2788691|NCT00604019|Secondary|Safety, Arrythmia - Yes or no for Each Group||28 days|||||||
2788692|NCT00604019|Primary|Efficacy|Dead at 28 days|28 days||||participants|||Number
2788693|NCT00603993|Secondary|Duration (Minutes) of the Presence of Morning Stiffness by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.|||minutes||Standard Deviation|Mean
2788694|NCT00603993|Secondary|Presence of Morning Stiffness by Visit|The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.|||participants|||Number
2788695|NCT00603993|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit|Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)||||mg/dL||Standard Deviation|Mean
2788696|NCT00603993|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)||||units on a scale||Standard Deviation|Mean
2788697|NCT00603993|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)||||mm on a scale||Standard Deviation|Mean
2788698|NCT00603993|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)||||mm on a scale||Standard Deviation|Mean
2788699|NCT00603993|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)||||mm on a scale||Standard Deviation|Mean
2788700|NCT00603993|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)||||SJC||Standard Deviation|Mean
2788701|NCT00603993|Secondary|Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)||||TJC||Standard Deviation|Mean
2788702|NCT00603993|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|Analysis was based on observed data.|||participants|||Number
2788703|NCT00603980|Secondary|Observer Rated Questionnaire 8) Maximum of Drug Strength|"The within patient rank (1-7) of maximum of the observer rated the subject on Drug Strength on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788704|NCT00603980|Secondary|Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal|"The within patient rank (1-7) of maximum of the observer rated the subject on Stimulation/Arousal on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788705|NCT00603980|Secondary|Observer Rated Questionnaire 6) Maximum of Confusion/Disorientation|"The within patient rank (1-7) of maximum of the observer rated the subject on Confusion/Disorientation on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788706|NCT00603980|Secondary|Observer Rated Questionnaire 5) Maximum of Speech|"The within patient rank (1-7) of maximum of the observer rated the subject on speech on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788707|NCT00603980|Secondary|Observer Rated Questionnaire 4) Maximum of Muscle Relaxation Posture|"The within patient rank (1-7) of maximum of the observer rated the subject on muscle relaxation (posture) on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788708|NCT00603980|Secondary|Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor|"The within patient rank (1-7) of maximum of the observer rated the subject on muscle relaxation (non-locomotor) on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||units on a scale||Standard Error|Least Squares Mean
2788709|NCT00603980|Secondary|Observer Rated Questionnaire 2) Maximum of Muscle Relaxation Locomotor|"The within patient rank (1-7) of maximum of the observer rated the subject on muscle relaxation (locomotor) on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Maximum of the 10 time points (predose through 9 hours) Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788710|NCT00603980|Secondary|Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness|"The within patient rank (1-7) of Maximum of Observer Rated Questionnaire (ORQ): A trained and blinded staff member completed observer ratings as the subject completed the questionnaires and psychomotor assessment testing at each time point.~The observer rated the subject on sedation/sleepiness, muscle relaxation, impaired posture, impaired speech, confusion/disorientation, stimulation/arousal and strength of drug effect on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect).~Maximum of the 10 time points (predose through 9 hours) Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|ORQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788711|NCT00603980|Secondary|"Maximum of DEQ Question 2 Rate Your Liking of the Drug Effect at the 10 Time Points (Predose Through 9 Hours)"|"The within patient rank (1-7) of maximum of the Rate your LIKING of the drug effect you are feeling RIGHT NOW; response options range from -4 to +4:~Dislike very much=-4, Dislike quite a bit=-3, Dislike somewhat=-2, Dislike, but not very much=-1, NEUTRAL OR NO EFFECT=0, Like, but not very much=1, Like somewhat=2, Like quite a bit=3, Like very much=4 Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|DEQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788770|NCT00603538|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.|The screening assay for anti-CP-751,871 antibodies was performed.|Day 1 of Cycles 1 (predose) and 4, and end of study|All participants were screened for the ADA.|||participants|||Number
2788712|NCT00603980|Secondary|"Maximum of DEQ Question 1 Rate the Strength of the Drug Effect (at the 10 Time Points, Predose Through 9 Hours)"|"The within patient rank (1-7) of Drug Effect Questionnaire question number 1: Rate the STRENGTH of the drug effect you are feeling RIGHT NOW; response options range for 0 to 4:~No drug effect at all=0, Possible mild effect, but not sure=1, Definite mild effect=2, Moderate strong drug effect=3, Very strong drug effect=4 Maximum of the 10 time points (predose through 9 hours) Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|DEQ was assessed at the 10 time points (predose through 9 hours)|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788713|NCT00603980|Secondary|"EDQ Question Number 7,What Would You be Willing to Pay for Today's Drug?"|"EDQ question number 7, What would you be willing to pay for today's drug?"|End of day for each of the 7 crossover treatments|Efficacy (crossover) Population, n=14. LSM & SEM are based on all 14 subjects completing all 7 treatments. PROC MIXED model used assigns the same SEM to all 7 treatments.|||Dollars ($)||Standard Error|Least Squares Mean
2788714|NCT00603980|Secondary|"EDQ Question Number 1, Rate the Overall Strength of the Drug Effect"|"The within patient rank (1-7) of End of Day question number 1, Rate the overall strength of the drug effect, response options range from 0-4:~0=No drug effect at all~Possible mild effect, but not sure~Definite mild effect~Moderate strong drug effect~Very strong drug effect Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|End of day for each of the 7 crossover treatments|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788715|NCT00603980|Secondary|"EDQ Question Number 6  Estimate the Amount of Money You Think the Drug You Took Today Would be Worth on the Street."|"EDQ question number 6 (of primary interest), Estimate the amount of money you think the drug you took today would be worth on the street."|End of day for each of the 7 crossover treatments|Efficacy (crossover) Population, n=14. LSM & SEM are based on all 14 subjects completing all 7 treatments. PROC MIXED model used assigns the same SEM to all 7 treatments.|||Dollars ($)||Standard Error|Least Squares Mean
2788716|NCT00603980|Secondary|"EDQ Question Number 2 Rate Your Overall Liking of the Drug Effect"|"The within patient rank (1-7) of End of Day question number 2 (of primary interest), Rate your overall liking of the drug effect, response options range from -4 to +4:~4=Dislike very much~3=Dislike quite a bit~2=Dislike somewhat~1=Dislike, but not very much 0=NEUTRAL OR NO EFFECT~1=Like, but not very much~2=Like somewhat~3=Like quite a bit~4=Like very much Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect"|End of day for each of the 7 crossover treatments|"Efficacy (crossover) Population, n=14~LS Means via SAS PROC MIXED non-parametric model (ranks within subject), treatment and period as fixed effects, ddf=72~LSM & SEM are based on the ranks of scores within each subject across all 14 subjects completing all 7 treatments.~PROC MIXED model assigns the same SEM to all 7 treatments."|||Rank across the 7 treatments||Standard Error|Least Squares Mean
2788717|NCT00603980|Primary|"Response to EDQ Question Number 5, Rate the Degree to Which You Would Like to Take the Drug Again"|"The End of Day Questionnaire (EDQ) is a 7-question computerized instrument in which subjects rate the overall effect of the drug they received that day. The primary outcome measure for this trial is the categorical response to question number 5, Rate the degree to which you would like to take the drug again, with a numerical value assigned to each of the responses allowed: 0=Not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Very much"|End of day for each of the 7 crossover treatments|Efficacy (crossover) Population, n=14. LSM & SEM are based on all 14 subjects completing all 7 treatments. PROC MIXED model used assigns the same SEM to all 7 treatments.|||units on a scale||Standard Error|Least Squares Mean
2788718|NCT00603915|Secondary|Number of Participants With the Responses Outlined|"Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.~Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease."|Measured every 2 cycles until the participant is off treatment.||||Participants|||Number
2788719|NCT00603915|Primary|Progression Free Survival.|From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.|From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.||||Months||95% Confidence Interval|Mean
2788720|NCT00603902|Secondary|Percent Change in Body Weight From Baseline to Week 52|The percent change in body weight (kg) from baseline to week 52.|Baseline and Week 52|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
2788721|NCT00603902|Primary|Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52|The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.|Baseline and Week 52|Modified Intent to Treat (MITT) with last observation carried forward (LOCF)|||percentage of participants|||Number
2788722|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||units on a scale||Full Range|Mean
2789829|NCT00594685|Secondary|The Time to First Bleeding Event With Current Therapies for Isolated HIT|The time to first bleeding event was analyzed using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT||||Days||Standard Error|Mean
2788723|NCT00603889|Secondary|100 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||units on a scale||Full Range|Mean
2788724|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||units on a scale||Full Range|Mean
2788725|NCT00603889|Primary|100 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application||||Units on a scale||Full Range|Mean
2788726|NCT00603837|Primary|Neonatal Intensive Care Unit (NICU) Admission Temperature|Axillary temperature of the infant upon arrival to the neonatal intensive care unit.|At time of admission to the NICU - usually within 10-15 min of birth||||Celsius degrees||Standard Deviation|Mean
2788727|NCT00603798|Secondary|Local Skin Reactions (LSR)|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days).|The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)|All participants were evaluated for local skin reactions (LSR) at every visit. The ITT population was used. Only subjects who received treatment in both cycles are included in the analysis.|||units on a scale * days||Standard Deviation|Mean
2788728|NCT00603798|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change.|At all visits - Baseline through the Week 17 EOS visit|Intent to treat (ITT) population using last observation carried forward (LOCF).|||percentage of participants||Full Range|Median
2788729|NCT00603798|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).|||participants|||Number
2788730|NCT00603798|Primary|Number of Participants With Complete Clearance of AK Lesions|"Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or subclinical lesion that had not been identified at Baseline."|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF), primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).|||participants|||Number
2788731|NCT00603746|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2788732|NCT00603746|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2788733|NCT00603746|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results|||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
2788734|NCT00603746|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||scores on a scale||Standard Deviation|Mean
2788940|NCT00603239|Secondary|Number of Subjects Who Experienced an Episode of Minor Hypoglycemia|Overall number of subjects who experienced an episode of minor hypoglycemia.|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||Participants|||Number
2788735|NCT00603746|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
2788736|NCT00603746|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cells (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2788737|NCT00603746|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2788738|NCT00603746|Secondary|Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8|Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2788739|NCT00603746|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2788740|NCT00603746|Secondary|Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8|Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2788741|NCT00603746|Secondary|Red Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2788742|NCT00603746|Secondary|Platelet Count and White Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2788743|NCT00603746|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2789022|NCT00602667|Secondary|Change in Neurocognitive Performance in Visual-spatial Reasoning and Processing Speed|Processing speed will be measured using the WJIII. Visual perception and visual-motor integration will be measured using the Beery VMI.|Baseline and up to 5 years after completion of therapy.|||||||
2788745|NCT00603746|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage in the blood||Standard Deviation|Mean
2788746|NCT00603746|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
2788747|NCT00603746|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
2788748|NCT00603746|Secondary|Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
2788749|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2788750|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2788751|NCT00603746|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2788752|NCT00603746|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2788769|NCT00603538|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline up to 6 cycles (1 cycle = 21 days)|Full Analysis Set (FAS) was defined as all participants who met all of the following criteria; 1) Those who were diagnosed with NSCLC, 2) Those who received at least one dose of the study treatment, and 3) Those who had efficacy data after the start of the study treatment.|||participants|||Number
2788753|NCT00603746|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.|||Liters||Standard Error|Least Squares Mean
2788754|NCT00603733|Secondary|Frequency of Adverse Events|Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.|From baseline to week 24|Safety dataset for Active and Maintenance Phases|||percentage of patients with TEAEs|||Number
2788755|NCT00603733|Primary|Maintenance Phase: Proportion of Subjects Experiencing Relapse|Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy|Up to week 24|Per Protocol Analysis Set|||% of subjects with relapse (90% CI)||90% Confidence Interval|Number
2788756|NCT00603733|Primary|Active Phase: Proportion of Active Subjects Achieving Overall Improvement|"Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).~Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.~A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score."|From baseline to week 8|Per Protocol Analysis Set|||percentage of participants||90% Confidence Interval|Number
2788757|NCT00603720|Primary|Effect of NO Inhibition on Myocardial Substrate Metabolism in Humans|Determine in young healthy volunteers the extent to which acute inhibition of nitric oxide production will effect a shift in myocardial substrate utilization characterized as a decline in myocardial fatty acid oxidation, and perhaps myocardial fatty acid utilization, and increase in myocardial glucose uptake, and whether these changes are associated with a decline in LV function.|1-3 months|PI left institution. Efforts were made to access the data, without success so there is no access to the data.|||percentage of substrate||90% Confidence Interval|Mean
2788758|NCT00603642|Secondary|Rescue Medication(s)|Requirement for rescue medication(s) during treatment by the participant|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Participants|||Number
2788759|NCT00603642|Secondary|Weeks With Platelet Count Between 50 and 200|Number of weeks with platelet count between 50 x 10^9/L and 200 x 10^9/L inclusive during week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Weeks||Standard Deviation|Mean
2788760|NCT00603642|Secondary|Change From Baseline in Mean of Last 4 Weekly Platelet Counts|Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||10^9/L||Standard Deviation|Mean
2788761|NCT00603642|Secondary|Increased Platelet Count From Baseline of at Least 20 x 10^9/L|An increase in platelet count of at least 20 x 10^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.|Baseline, 12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Participants|||Number
2788762|NCT00603642|Primary|Weeks With Weekly Platelet Response|Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo|||Weeks||Inter-Quartile Range|Median
2788763|NCT00603590|Secondary|LDL Cholesterol|Serum LDL cholesterol|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward|||mg/dL||Standard Deviation|Mean
2788764|NCT00603590|Secondary|Diastolic Blood Pressure|Mean of two seated diastolic blood pressures|One year|Analysis by intention to treat. Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward.|||mm Hg||Standard Deviation|Mean
2788765|NCT00603590|Primary|Systolic Blood Pressure|Systolic blood pressure. Mean of two seated measurements.|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward|||mm Hg||Standard Deviation|Mean
2788766|NCT00603564|Secondary|PaO2/FiO2 Ratio Mantainance|the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement|1, 6, 12, 24 and 48 hours||||participants|||Number
2788767|NCT00603564|Primary|Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315||on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315||||minute||Standard Deviation|Mean
2788768|NCT00603538|Secondary|Progression-Free Survival (PFS)|PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to 6 cycles (1 cycle = 21 days)|Number of participants with defined event (all causality death or PD) was too few to conduct summary analysis.||||||
2789023|NCT00602667|Secondary|Change in Quantitative MR Measures in the Right Frontal-parietal Regions||Baseline and up to 5 years after completion of therapy|||||||
2788771|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)|IGF-BP3 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.|||mg/L||Standard Deviation|Mean
2788772|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.|||ng/L||Standard Deviation|Mean
2788773|NCT00603538|Secondary|Observed Accumulation Ratio (Rac)|The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau|Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.|||ratio||Standard Deviation|Mean
2788774|NCT00603538|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)|AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.|Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.|||mg*h/mL||Standard Deviation|Mean
2788775|NCT00603538|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)|AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.|Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.|||mg*h/L||Standard Deviation|Mean
2788776|NCT00603538|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|Participants with sufficient sampling to capture the terminal disposition phase were analyzed.|||hours||Standard Deviation|Mean
2788777|NCT00603538|Secondary|Maximum Observed Concentration (Cmax) of CP-751,871||Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|"The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.~n = the number of participants analyzed"|||mg/L||Standard Deviation|Mean
2788778|NCT00603538|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.|Cycle 1|DLT Evaluation Set comprised of participants who were treated with CP-751,871. One participant in the 10 mg/kg cohort who discontinued from the study due to an adverse event occurred prior to CP-751,871 administration was excluded from this analysis set.|||participants|||Number
2788779|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
2788780|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.|||Participants|||Number
2788781|NCT00603525|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788782|NCT00603525|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Months||Full Range|Median
2788783|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788784|NCT00603525|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.|||Participants|||Number
2788785|NCT00603525|Secondary|Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.|From basline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788786|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788787|NCT00603525|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788788|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788789|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788790|NCT00603525|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788791|NCT00603525|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788792|NCT00603525|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788793|NCT00603525|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788794|NCT00603525|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Participants|||Number
2788795|NCT00603525|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population|||Participants|||Number
2788796|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
2788797|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||participants|||Number
2788798|NCT00603525|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||Days||Standard Deviation|Mean
2788799|NCT00603525|Secondary|Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
2789155|NCT00601458|Secondary|Time to First Request of PCA Hydromorphone|Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery||||Hours||Inter-Quartile Range|Median
2788800|NCT00603525|Secondary|Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.|||scores on a scale||Standard Deviation|Mean
2788801|NCT00603525|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population|||scores on a scale||Standard Deviation|Mean
2788802|NCT00603525|Secondary|Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period|||Scores on a scale||Standard Deviation|Mean
2788803|NCT00603525|Secondary|Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24|The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.|Baseline, Week 12, and Week 24|Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.|||grams per Liter (g/L)||Full Range|Median
2788804|NCT00603525|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24|Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788805|NCT00603525|Secondary|Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 4|ITT Population. Only those participants contributing values at the relevant visit were analyzed.|||Units/Liter||Full Range|Median
2788806|NCT00603525|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788826|NCT00603525|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population|||participants|||Number
2788807|NCT00603525|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788808|NCT00603525|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788809|NCT00603525|Secondary|Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788810|NCT00603525|Secondary|Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788811|NCT00603525|Secondary|Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24|"A horizontal VAS of 100 mm was used to report the participant's level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788812|NCT00603525|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||millimeters per hour (mm/hr)||Full Range|Median
2788813|NCT00603525|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||milligrams per liter (mg/L)||Full Range|Median
2788814|NCT00603525|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||swollen joints||Full Range|Median
2788815|NCT00603525|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||tender joints||Full Range|Median
2788816|NCT00603525|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||scores on a scale||Full Range|Median
2788817|NCT00603525|Secondary|Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.||||||
2788818|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
2788819|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
2788820|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
2788821|NCT00603525|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
2788822|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
2788823|NCT00603525|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.|||scores on a scale||Standard Deviation|Mean
2788824|NCT00603525|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
2788825|NCT00603525|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||participants|||Number
2788827|NCT00603525|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.|||participants|||Number
2788828|NCT00603512|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788829|NCT00603512|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788830|NCT00603512|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788831|NCT00603512|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788832|NCT00603512|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788833|NCT00603512|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (=<) 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788834|NCT00603512|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.|Baseline up to Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||units on a scale*weeks||Standard Deviation|Mean
2788847|NCT00603512|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
2788835|NCT00603512|Secondary|Numeric Index of American College of Rheumatology Response (ACR-n)|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||units on a scale||Standard Deviation|Mean
2788836|NCT00603512|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
2788837|NCT00603512|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
2788838|NCT00603512|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788839|NCT00603512|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2788840|NCT00603512|Secondary|Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2788841|NCT00603512|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2788842|NCT00603512|Secondary|Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2788843|NCT00603512|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2788844|NCT00603512|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2788845|NCT00603512|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2788846|NCT00603512|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
2788848|NCT00603512|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
2788849|NCT00603512|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
2788850|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in tender or swollen joint counts and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
2788851|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender or swollen joint counts and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
2788852|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender or swollen joint counts and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/End of Treatment (EOT)|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
2788853|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.|||Percentage of Participants|||Number
2788854|NCT00603512|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using Last observation carried forward (LOCF) method.|||Percentage of Participants|||Number
2788855|NCT00603473|Secondary|Percent Change in Seizure Frequency (PCH)|PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T−B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.|||Percent Change||Full Range|Median
2788856|NCT00603473|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.|||Percentage of Subjects||95% Confidence Interval|Mean
2788857|NCT00603473|Primary|Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures|The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.|||ratio||95% Confidence Interval|Mean
2788907|NCT00603291|Primary|Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52|The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.|Baseline and Week 52|Modified Intent to Treat (MITT) with last observation carried forward (LOCF)|||percentage of participants|||Number
2788858|NCT00603447|Primary|Number of Participants With Dose-limiting Toxicities|"Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic~≥ Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy~≥ Grade 4 fatigue persisting > 7 days~Treatment delay for toxicity > 21 days~Hematologic~Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) > 7 days~Febrile neutropenia (ANC < 1,000/mm³ with fever ≥ 38.3ºC)~Grade 4 thrombocytopenia (platelets < 25,000/mm³) for > 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding~Treatment delay for toxicity > 21 days.~The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort."|Cycle 1, 28 days|Safety population for the dose escalation portion of the study|||participants|||Number
2788859|NCT00603447|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.~Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy."|From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.|Safety population consisting of all treated participants|||participants|||Number
2788860|NCT00603408|Secondary|Provide Samples for the Development of the FNA Assay||At time of IVAD placement and at time of surgery|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.||||||
2788861|NCT00603408|Secondary|Develop Animal Models of Triple Negative Breast Cancers||5 years|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.||||||
2788862|NCT00603408|Secondary|Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response||5 years|Collecting bone marrow samples were optional and at the time of surgery only 2 patients participated and at the time of port removal submission none of the patients participated.||||||
2788863|NCT00603408|Secondary|Number of Participants With Medical Toxicities|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.|30 days post surgery (week 17-18)||||participants|||Number
2788864|NCT00603408|Secondary|Number of Participants With Surgical Complications||30 days post surgery (week 17-18)||||participants|||Number
2788865|NCT00603408|Secondary|Overall Survival Rate (OS)|OS = Time from registration until death from any cause|Until study was terminated (23.5 months)||||percentage of participants|||Number
2788866|NCT00603408|Secondary|Time to Disease Progression|Time to disease progression: time from registration until objective tumor progression; does not include deaths|Until study was terminated (23.5 months)|At the time of study termination, no participants had experienced disease progression.||||||
2788867|NCT00603408|Primary|Overall Response|"Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level~Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,~Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions."|At the time of surgery (week 13)||||participants|||Number
2788868|NCT00603382|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2788869|NCT00603382|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2788870|NCT00603382|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.|||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
2788871|NCT00603382|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||scores on a scale||Standard Deviation|Mean
2789905|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|ITT population|||Percentage of participants||95% Confidence Interval|Number
2788872|NCT00603382|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
2788873|NCT00603382|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
2788874|NCT00603382|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2788875|NCT00603382|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2788876|NCT00603382|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2788877|NCT00603382|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2788878|NCT00603382|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2788879|NCT00603382|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2788880|NCT00603382|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2788908|NCT00603278|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2788881|NCT00603382|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1||Standard Deviation|Mean
2788882|NCT00603382|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage||Standard Deviation|Mean
2788883|NCT00603382|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
2788884|NCT00603382|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
2788885|NCT00603382|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||participants|||Number
2788886|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2788887|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2788888|NCT00603382|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at th end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2788889|NCT00603382|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2788909|NCT00603278|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2788890|NCT00603382|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1(the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.|||Liters||Standard Error|Least Squares Mean
2788891|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 - 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788892|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 - 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788893|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 - 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 - 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788894|NCT00603304|Secondary|Jenkins Sleep Scale Score|The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 - 7 days, three being 8 - 14 days, four being 15 - 21 days, and five being 22 - 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788895|NCT00603304|Secondary|International Continence Society Male Incontinence Symptom (ICSmale IS) Score|The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788896|NCT00603304|Secondary|Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.|The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 - 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks.|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788897|NCT00603304|Secondary|International Index of Erectile Function (IIEF)Scale Score.|The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788898|NCT00603304|Secondary|Prostate Specific Antigen (PSA) Level|The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||ng/mL||95% Confidence Interval|Mean
2788899|NCT00603304|Secondary|Post-void Residual|The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.|||mL||95% Confidence Interval|Mean
2788900|NCT00603304|Secondary|Peak Uroflow|The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||mL/sec||95% Confidence Interval|Mean
2788901|NCT00603304|Secondary|American Urological Association(AUA) Nocturia Item|The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788902|NCT00603304|Secondary|International Prostate Symptom Score Quality of Life (IPSS QOL) Score|The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788903|NCT00603304|Secondary|Benign Prostate Hyperplasia (BPH) Impact Index Score|The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788904|NCT00603304|Secondary|Participants Global Assessments of Improvement and Satisfaction at End of Study.|Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788905|NCT00603304|Primary|Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.|The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.|||units on a scale||95% Confidence Interval|Mean
2788906|NCT00603291|Secondary|Percent Change in Body Weight From Baseline to Week 52|The percent change in body weight (kg) from baseline to week 52.|Baseline and Week 52|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
2788910|NCT00603278|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.|||Nanomole per 24 hours (nmol/24hr)||Full Range|Median
2788911|NCT00603278|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||scores on a scale||Standard Deviation|Mean
2788912|NCT00603278|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Urine specific gravity at Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
2788913|NCT00603278|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2788914|NCT00603278|Secondary|Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8|Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2788915|NCT00603278|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2788916|NCT00603278|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Grams per liter (G/L)||Standard Deviation|Mean
2788917|NCT00603278|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2788918|NCT00603278|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2788919|NCT00603278|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2788920|NCT00603278|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Grams per liter (G/L)||Standard Deviation|Mean
2788921|NCT00603278|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Proportion of 1||Standard Deviation|Mean
2788922|NCT00603278|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
2788923|NCT00603278|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.|From Baseline up to Week 8/Early Withdrawal|ITT Population|||Participants|||Number
2788924|NCT00603278|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||Participants|||Number
2788925|NCT00603278|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population|||Participants|||Number
2788926|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2788927|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2788928|NCT00603278|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2788929|NCT00603278|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2788939|NCT00603239|Secondary|Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score|"IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = never true to 5 = always true."|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||units on a scale||Standard Error|Least Squares Mean
2790110|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2788930|NCT00603278|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.|||Liters||Standard Error|Least Squares Mean
2788931|NCT00603265|Secondary|Change From Baseline in NPRS After Walking 50 Feet in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable post-walk NPRS data.|||units on a scale||Standard Error|Least Squares Mean
2788932|NCT00603265|Secondary|Change From Baseline in NPRS at Rest in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable at-rest NPRS data.|||units on a scale||Standard Error|Least Squares Mean
2788933|NCT00603265|Secondary|Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score|At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable 24-hour NPRS data.|||units on a scale||Standard Deviation|Mean
2788934|NCT00603265|Secondary|Change in Sleep Interference Scale (SIS) From Baseline|"Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4."|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable SIS data|||units on a scale||Standard Error|Least Squares Mean
2788935|NCT00603265|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a participant-rated instrument that measures the change in the participant's overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented.|Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable PGIC data.|||participants|||Number
2788936|NCT00603265|Secondary|Percentage of Responders|A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm.|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable NPRS data.|||percentage of participants|||Number
2788937|NCT00603265|Primary|Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable NPRS data. Baseline-observation-carried-forward (BOCF) was used to impute missing postbaseline values for participants who were discontinued from the study early.|||units on a scale||Standard Error|Least Squares Mean
2788938|NCT00603239|Secondary|Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score|EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||units on a scale||Standard Error|Least Squares Mean
2788941|NCT00603239|Secondary|Change in Insulin Sensitivity.|Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||ratio||Standard Error|Least Squares Mean
2788942|NCT00603239|Secondary|Change in Beta-cell Function|Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||ratio||Standard Error|Geometric Mean
2788943|NCT00603239|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||cm||Standard Deviation|Mean
2788944|NCT00603239|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||kg||Standard Error|Least Squares Mean
2788945|NCT00603239|Secondary|Change in Fasting Serum Glucose (FSG)|Change in FSG from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||mmol/L||Standard Error|Least Squares Mean
2788946|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 6.5%|Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||percentage of participants|||Number
2788947|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 7%|Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.|||percentage of participants|||Number
2788948|NCT00603239|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)|baseline and 26 weeks|The number of participants was determined based on sample size calculations using parameter estimates from prior study H8O-MC-GWAP (NCT00099320), with change from baseline HbA1c as the primary efficacy measure. Primary analysis is reported for intent to treat population (ITT), last observation carried forward (LOCF).|||Percentage||Standard Error|Least Squares Mean
2788949|NCT00603187|Secondary|LH Blood Serum Concentration|Blood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days||||iu/L||Standard Deviation|Mean
2788950|NCT00603187|Secondary|FSH Blood Serum Concentration|Blood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days||||iu/L||Standard Deviation|Mean
2788951|NCT00603187|Primary|Testosterone Blood Serum Concentration|Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days||||ng/dl||Standard Deviation|Mean
2788952|NCT00603044|Secondary|Adjusted Volume of the Removed Adenoids|To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||mL/kg x100||Standard Error|Mean
2788953|NCT00603044|Primary|Amount of TGF Secreted by Adenoid Cells After PHA Stimulation|Amount of TGF secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||picogram per milliliter (pg/mL)||Full Range|Median
2788954|NCT00603044|Primary|Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation|Amount of IL-10 secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||picogram per milliliter (pg/mL)||Full Range|Median
2788955|NCT00603044|Primary|IL-10 Staining Intensity|IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||IOD/100 micrometer squared||Standard Error|Mean
2788956|NCT00603044|Primary|Number of CD4 Pos/FOXP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||cells per High power field (HPF)||Full Range|Median
2788957|NCT00603044|Primary|Number of CD25 Pos/FoxP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.|||cells per High power field (HPF)||Full Range|Median
2788958|NCT00603018|Primary|Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors|We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI−DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3|Baseline and 8 weeks||||mL/cm^3||Standard Deviation|Mean
2789311|NCT00600353|Secondary|Impact of Nausea and Vomiting on the Quality of Life of Patients Undergoing Autologous HSCT|To determine quality of life, subjects' responses to the modified Osoba modules were converted to a 0 - 100 scale, with higher scores indicative of better QOL|24 hours, Day 3, Day 7|||||||
2788959|NCT00602979|Primary|Percentage Distribution of Cook's Modification of Cormack-Lehane's Grading System. Each Study Subject Will Receive a Grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane Grading System.|"Percentage distribution of Cook's modification of Cormack-Lehane's grading system. This is a classification that records the best laryngeal view obtained with or without anterior laryngeal pressure. Each study subject will receive a grade of 1, 2A, 2B, 3A, 3B, or 4 in the Cormack-Lehane grading system. Grades 1 and 2A classify as an easy view: when the laryngeal inlet is visible. Grades 2B and 3A classify as restricted: when the posterior glottic structures are visible or the epiglottis is visible and can be lifted. Grades 3B and 4 classify as difficult: when the epiglottis cannot be lifted or when no laryngeal structures are visible.~Cook's modification of Cormack-Lehane's Grades 1=1, 2=2A,3=2B, 4=3A, 5=3B, 6=4."|1 time during laryngoscopy||||units on a scale||Standard Deviation|Mean
2788960|NCT00602953|Primary|Disposition Index (DI)|Disposition index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Disposition index (DI) was used to characterize the correlation between β-cell sensitivity and insulin sensitivity and was determined using formula DI = AIRg x SI (from outcomes 2 and 3). Higher numbers indicates a better improvement in beta-cell function.|At screening visit.||||Number||Inter-Quartile Range|Median
2788961|NCT00602953|Primary|Insulin Sensitivity (SI)|"Sensitivity index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).~Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Higher numbers indicates better insulin sensitivity Insulin sensitivity was estimated as Matsuda index using formula = 10,000 / (FPG x FPI x Glucosemean0-180 x Insulinmean0-180)0.5, where FPG = fasting plasma glucose and FPI = fasting plasma insulin."|At screening visit.||||min-1 per pU/mL x 10v4||Inter-Quartile Range|Median
2788962|NCT00602953|Primary|Beta-cell Function; AIRg - Acute Insulin Response to Glucose|"Beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).~AIRg - acute insulin response to glucose. Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected."|At screening visit.||||microU/mL x min||Inter-Quartile Range|Median
2788963|NCT00602953|Primary|Pancreatic and Liver Fat|Pancreatic and liver triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).|Within 1 month after screening visit.||||percent||Inter-Quartile Range|Median
2788964|NCT00602927|Secondary|Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)|We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.|Day 13|Participants who completed both study phases were included in the analysis. Other participants (n=3) were excluded due to measurement artifact.|||Milliseconds||Standard Deviation|Mean
2788965|NCT00602927|Primary|Percent Change BOLD Signal|We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.|Day 13|Participants who completed both study phases were included in the analyses (n=25). Additional participants (n=3) were excluded due to measurement artifact.|||BOLD Signal Change (3-back minus 0-back)||Standard Error|Mean
2788966|NCT00602836|Secondary|Treatment Free Survival (TFS)|Treatment Free Survival (TFS) was defined as the time from registration to the earliest date documentation of subsequent treatment or death, whichever came first. Participants were followed for a maximum of 5 years from registration. The median TFS with 95% CI was estimated using the Kaplan Meier method.|time from registration to progression (up to 5 years)|All patients that registered to treatment were included in this analysis.|||months||95% Confidence Interval|Median
2788967|NCT00602836|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|time from registration to death (up to 5 years)|All patients who registered were included in this analysis.|||months||95% Confidence Interval|Median
2788968|NCT00602836|Secondary|Number of Participants With a Response (CR, nPR, PR)|Response criteria described in above outcomes.|During treatment (up to 5 years)|All patients that registered to this trial with the intent-to-treat were included in this analysis.|||Participants|||Count of Participants
2788969|NCT00602836|Secondary|Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells to determine if there was any MRD.|12 months|All patients that began consolidation with a CR and MRD-negative status were included in this analysis.|||Participants|||Count of Participants
2788970|NCT00602836|Secondary|Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide|"According to the NCIWG criteria, response is defined as follows:~nPR: Meets all criteria for CR, as described above, except the presence of residual clonal nodules in the bone marrow PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions SD: participant who does not meet any of the criteria described above"|12 months|All patients that began lenalidomide consolidation with either and nPR, PR, or SD were included in this analysis.|||Participants|||Count of Participants
2788971|NCT00602836|Primary|Number of Participants With Complete Response (CR)|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG), requires all of the following for a period of at least 2 months:~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|12 months||||participants|||Number
2788972|NCT00602797|Secondary|Response Rate Based on RECIST Criteria|The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter|Up to 5 years||||Participants|||Count of Participants
2788973|NCT00602797|Secondary|Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events|Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events.|Up to week 17||||Participants|||Count of Participants
2788974|NCT00602797|Primary|Progression-free Survival.|Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions.|Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years||||Months||95% Confidence Interval|Median
2788975|NCT00602771|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.|6 months||||participants|||Number
2788976|NCT00602667|Secondary|Rate of Distant Disease Progression|Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.|1 year after completion of radiation therapy for last patient|Eligible intermediate-risk patients who received focal radiation were included in this analysis. Of the 156 intermediate risk patients, 121 started radiation.|||percentage of participants||95% Confidence Interval|Number
2788977|NCT00602667|Secondary|Rate of Local Disease Progression|Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.|1 year after completion of radiation therapy for last patient|Eligible intermediate-risk patients who received focal radiation were included in this analysis. Of the 156 intermediate risk patients, 121 started radiation.|||Percentage of participants||95% Confidence Interval|Number
2788978|NCT00602667|Secondary|OSI-420 AUC0-24h|Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-dose, 1, 2, 4, 8, and 24 hours post-dose|Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788979|NCT00602667|Secondary|Erlotinib AUC0-24h|Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-dose, 1, 2, 4, 8, and 24 hours post-dose|Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788980|NCT00602667|Secondary|Erlotinib Apparent Volume of Central Compartment|Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis.|Pre-dose, 1, 2, 4, 8, and 24 hours post-dose|Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.|||L/m^2||Full Range|Median
2788981|NCT00602667|Secondary|Erlotinib Apparent Oral Clearance|Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis.|Pre-dose, 1, 2, 4, 8, and 24 hours post-dose|Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2788982|NCT00602667|Secondary|Topotecan AUC0-24h in Maintenance Chemotherapy|Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.|Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose|Eligible patients who received oral topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.|||µg·h/L||Full Range|Median
2788983|NCT00602667|Secondary|Topotecan AUC0-24h in Consolidation Chemotherapy|Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.|Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion|Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.|||µg·h/L||Full Range|Median
2789061|NCT00602472|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2788984|NCT00602667|Secondary|Topotecan Apparent Oral Clearance in Maintenance Chemotherapy|Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis.|Pre-dose, 0.25, 1.5 and 6 hours post-dose|Eligible patients who received oral topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.|||L/h||Full Range|Median
2788985|NCT00602667|Secondary|Topotecan Clearance in Consolidation Chemotherapy|Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis.|Pre-infusion, 5 min., 1, and 3 hours from end of infusion|Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.|||L/h/m^2||Full Range|Median
2788986|NCT00602667|Secondary|Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan|Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported.|Pre-infusion, 5 min., 1, and 3 hours from end of infusion|Eligible patients who received topotecan with PK-guided dosage adjustment during consolidation therapy were included in this analysis. Per protocol, low-risk and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.|||participants|||Number
2788987|NCT00602667|Secondary|Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan|Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported.|Pre-infusion, 5 min., 1, and 3 hours from end of infusion|Eligible patients who received topotecan with empirical dosage during consolidation therapy were included in this analysis. Per protocol, low-risk and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.|||participants|||Number
2788988|NCT00602667|Secondary|CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1|Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose|Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788989|NCT00602667|Secondary|CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2|Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788990|NCT00602667|Secondary|CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1|Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788991|NCT00602667|Secondary|CEPM AUC0-24h in Induction Chemotherapy|Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788992|NCT00602667|Secondary|4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1|4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose|Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788993|NCT00602667|Secondary|4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2|4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788994|NCT00602667|Secondary|4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1|4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788995|NCT00602667|Secondary|4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy|4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2789077|NCT00602355|Secondary|Global Illness Severity Based on Clinical Global Impression (CGI) Scale|Measure total ranges from 1 to 7, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
2788996|NCT00602667|Secondary|Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1|Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis.|Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose|Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788997|NCT00602667|Secondary|Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2|Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788998|NCT00602667|Secondary|Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1|Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2788999|NCT00602667|Secondary|Cyclophosphamide AUC0-24h in Induction Chemotherapy|Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2789000|NCT00602667|Secondary|Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1|Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.|Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose|Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2789001|NCT00602667|Secondary|Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2|Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2789002|NCT00602667|Secondary|Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1|Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2789003|NCT00602667|Secondary|Cyclophosphamide Clearance in Induction Chemotherapy|Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.|Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion|Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis..|||L/h/m^2||Full Range|Median
2789004|NCT00602667|Secondary|Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.|42 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.|||µmol/L||Full Range|Median
2789005|NCT00602667|Secondary|Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.|42 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.|||µmol/L||Full Range|Median
2789006|NCT00602667|Secondary|Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.|42 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.|||µmol/L||Full Range|Median
2789007|NCT00602667|Secondary|Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.|42 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis.|||µmol/L||Full Range|Median
2789008|NCT00602667|Secondary|Methotrexate AUC0-66h in Induction Cycle 4|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2789078|NCT00602355|Secondary|Depression Illness Severity Based on Beck Depression Inventory (BDI)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
2789009|NCT00602667|Secondary|Methotrexate AUC0-66h in Induction Cycle 3|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2789010|NCT00602667|Secondary|Methotrexate AUC0-66h in Induction Cycle 2|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2789011|NCT00602667|Secondary|Methotrexate AUC0-66h in Induction Cycle 1|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis.|||µmol·h/L||Full Range|Median
2789012|NCT00602667|Secondary|Methotrexate Volume of Central Compartment in Induction Cycle 4|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.|||L/m^2||Full Range|Median
2789013|NCT00602667|Secondary|Methotrexate Volume of Central Compartment in Induction Cycle 3|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.|||L/m^2||Full Range|Median
2789014|NCT00602667|Secondary|Methotrexate Volume of Central Compartment in Induction Cycle 2|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.|||L/m^2||Full Range|Median
2789015|NCT00602667|Secondary|Methotrexate Volume of Central Compartment in Induction Cycle 1|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis.|||L/m^2||Full Range|Median
2789016|NCT00602667|Secondary|Methotrexate Clearance in Induction Cycle 4|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2789017|NCT00602667|Secondary|Methotrexate Clearance in Induction Cycle 3|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2789018|NCT00602667|Secondary|Methotrexate Clearance in Induction Cycle 2|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of MTX|Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.|||L/h/m^2||Full Range|Median
2789019|NCT00602667|Secondary|Methotrexate Clearance in Induction Cycle 1|Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.|Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)|Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis|||L/h/m^2||Full Range|Median
2789020|NCT00602667|Secondary|Longitudinal Change in Growth Hormone Secretion|The intent of this objective is to estimate the longitudinal change in abnormal GH secretion as measured by mean peak GH values via a mixed effects model for the patients who receive PBT.|Baseline, end of therapy, and at 6- and 24-months after completion of therapy|||||||
2789021|NCT00602667|Secondary|Number of Participants With Endocrinopathy|Serial GH testing (at baseline, the end of therapy, and at 6 and 24 months after completion of therapy) will be performed on consenting patients in order to estimate longitudinal change in GH secretion as measured by mean peak GH values, with the intent to explore associations with radiation dose to the hypothalamus. Since determination of proton- or photon-based radiotherapy is not based on randomization, it will not be possible to compare the endocrine outcome between the patients with and without PBT. However, the differences between these two clinical cohorts with respect to clinical and demographic variables of interest will be summarized via descriptive statistics.|Baseline, end of therapy, and at 6- and 24-months after completion of therapy|||||||
2789024|NCT00602667|Secondary|Change in Neurocognitive Performance in Attention, Working Memory, and Fluency|Neurocognitive performance is assessed using a comprehensive battery of standard tests. Sustained attention is measured using the TOVA; selective auditory attention is measured using the WJIII; nonverbal attention span is measured using the SB-V Block Span subset. Working memory is measured using the WJIII. Fluency is measured using is also measured using the WJIII.|Baseline and prior to cycle A1 (~6 months) and at end of therapy and at 12, 24, 36, 48 and 60 months after completion of therapy.|||||||
2789025|NCT00602667|Secondary|Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe||Baseline and up to 60 months after completion of therapy.|||||||
2789026|NCT00602667|Secondary|Change in Neuropsychological Performance|The primary interest is in global cognitive functioning. This is measured using the SB-V Routing subtests.|Baseline, 6- and 12-months from treatment initiation, and yearly after the first year (up to 5 years)|||||||
2789027|NCT00602667|Secondary|Pharmacogenetic Variation on CNS Transmitters||At study enrollment (Day 0)|||||||
2789028|NCT00602667|Secondary|Number and Type of Genetic Polymorphisms||At study enrollment (Day 0)|||||||
2789029|NCT00602667|Secondary|Change in Neurocognitive Performance|Age standardized performance on measures of global cognitive functioning, attention, processing speed and executive functions.|Baseline, at the completion of therapy, and every 12 months up to 60 months off therapy|||||||
2789030|NCT00602667|Secondary|Change in Concentration of Cerebrospinal Fluid (CSF) Neurotransmitters||Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date|||||||
2789031|NCT00602667|Secondary|Percent of PET Scans With Loss of Signal Intensity|Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay.|Up to 3 times during RT consolidation|Intermediate risk patients treated at St. Jude were eligible to receive proton beam therapy through referral to the University of Florida Proton Therapy Institute. Patients electing to receive PBT and post-treatment PET scans after the delivery of one treatment beam were included in the analysis.|||mean activation value (MAV)|Scans|Standard Deviation|Mean
2789032|NCT00602667|Secondary|Change in Neurostructure, Especially White Matter Volume and Integrity|Quantitative MRI measures of change in neurostructure (especially white matter volume and integrity) over time will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.|From baseline to 60 months off therapy|||||||
2789033|NCT00602667|Secondary|Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received|These data are based on patient diaries. For children <3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.|From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)|Eligible patients less than 3 years of age (n=273) constituted the study population for this analysis; 167 of these patients started the first course of maintenance and were included in this analysis (50 low-risk, 87 intermediate-risk, and 30 high-risk patients).|||Percentage of scheduled doses received||Standard Deviation|Mean
2789034|NCT00602667|Secondary|Percent of Patients With Sustained Objective Responses Rate After Consolidation|For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response.|8 weeks after completion of consolidation therapy (up to 8 months after on-study date)|Of the 50 high-risk patients that started consolidation chemotherapy, 38 had measurable residual disease after induction and were included in this result.|||percentage of participants||95% Confidence Interval|Number
2789035|NCT00602667|Secondary|Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity|For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.|At completion of consolidation therapy (up to 6 months after on-study date)|Eligible high-risk group patients who started therapy were included. Course 2 of consolidation and the 1st course of maintenance were used in this analysis and assessed for delays >7 days due to toxicity. Of the 76 high-risk patients that started induction therapy, 50 started consolidation (with 47 courses included in this analysis).|||Percentage of courses delayed|courses|95% Confidence Interval|Number
2789046|NCT00602667|Primary|Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients|Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.|From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment|All eligible medulloblastoma patients started methotrexate and were included (n=81). PFS estimates are reported by risk group.|||Percent Probability||95% Confidence Interval|Number
2789036|NCT00602667|Secondary|Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity|For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.|From on-study date up to 4 months after on-study date|Eligible high-risk group patients who started therapy were included in this analysis (n=76). 1 patient enrolled on the high-risk arm did not start therapy due to early disease progression and was excluded. Courses 2-4 of induction and the 1st consolidation course were used in this analysis. 76 patients (with 263 courses) were included.|||Percentage of courses delayed|courses|95% Confidence Interval|Number
2789037|NCT00602667|Secondary|Percentage of Patients With Objective Responses Rate to Induction Chemotherapy|For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response [ PR]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks.|From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)|Eligible intermediate and high risk group patients who received at least 1 dose of methotrexate were included in this analysis. One of the high risk patients did not start therapy and was excluded.|||Percentage of patients||95% Confidence Interval|Number
2789038|NCT00602667|Secondary|Overall Survival (OS) Compared to Historical Controls|OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.|1 year after treatment initiation of last patient|Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.|||Percent probability||95% Confidence Interval|Number
2789039|NCT00602667|Secondary|Event-free Survival (EFS) Compared to Historical Controls|EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.|From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years|Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.|||Percent probability||95% Confidence Interval|Number
2789040|NCT00602667|Secondary|Number of Successful Collections for Frozen and Fixed Tumor Samples|Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available.|Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment|All eligible patients enrolled (n=290) were included in this analysis. The numbers of patients with pre-study samples were considered for these results.|||Participants|||Count of Participants
2789041|NCT00602667|Secondary|Numbers of Patients With Molecular Abnormalities by Tumor Type|Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values.|Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment|Eligible patients with molecularly confirmed medulloblastoma (n=76) were included in these analyses. Not all patients had data available for each gene.|||Participants|||Count of Participants
2789042|NCT00602667|Secondary|Numbers of Patients With Gene Alterations|Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table.|Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment|Eligible medulloblastoma patients (n=81) were included in these analyses. Not all patients had data available for each gene.|||Participants|||Count of Participants
2789043|NCT00602667|Secondary|Number of Participants With Chromosomal Abnormalities|Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values.|Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment|Eligible medulloblastoma patients (n=81) were included in these analyses. 23 of 23 low risk patients had data available for this objective, as did 27/32 and 24/26 intermediate and high risk patients.|||Participants|||Count of Participants
2789044|NCT00602667|Primary|Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients|Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.|From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after|Eligible medulloblastoma patients (n=81) were included. EFS estimates are reported by risk group.|||Percent Probability||95% Confidence Interval|Number
2789045|NCT00602667|Primary|Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup|Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile.|From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment|Eligible patients with molecularly confirmed medulloblastoma (n=76) were included. PFS estimates are reported by methylation subgroup and risk group. There were no low-risk group 3 or group 4 patients.|||Percent Probability||95% Confidence Interval|Number
2789047|NCT00602641|Secondary|Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12|A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).|Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.|Patients who completed both baseline and cycle 12 QOL assessments.|||units on a scale||Standard Deviation|Mean
2789048|NCT00602641|Secondary|Very Good Partial Response (VGPR) Rate|Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.|Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.|Intention-to-treat (ITT) population|||proportion of participants||95% Confidence Interval|Number
2789049|NCT00602641|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treatment (ITT) population|||months||95% Confidence Interval|Median
2789050|NCT00602641|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the earlier of progression or death of any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treat (ITT) population|||months||95% Confidence Interval|Median
2789051|NCT00602537|Secondary|Treatment-Emergent Mood Symptoms|These subjects must be responders.|Measured at Weeks 12 and 36||||Participants|||Count of Participants
2789052|NCT00602537|Primary|Depressive Relapse|"These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered depressive relapse if relapsed by any of these times."|Weeks 16, 20, 24, 30, 36||||Participants|||Count of Participants
2789053|NCT00602472|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789054|NCT00602472|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789055|NCT00602472|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789056|NCT00602472|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789057|NCT00602472|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789058|NCT00602472|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789059|NCT00602472|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789060|NCT00602472|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789062|NCT00602472|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789063|NCT00602472|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|"The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment.~HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule."|||Percent||Standard Error|Mean
2789064|NCT00602472|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789065|NCT00602472|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789066|NCT00602459|Secondary|Time-to-progression in Patients With Del(11q22.3)|Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.|Up to 15 years|This endpoint is limited to patients with del(11q22.3).|||months||95% Confidence Interval|Median
2789067|NCT00602459|Secondary|Time-to-progression in Patients Without Del(11q22.3)|Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: >= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, >= 50% increase in the product of at least two lymphnodes, >= 50% increase in the enlargement of the liver and/or spleen.|Up to 15 years|This endpoint is limited to patients without del(11q22.3).|||months||95% Confidence Interval|Median
2789068|NCT00602459|Secondary|PFS Rate of Patients With Del(11q22.3)|Proportion of del (11q22.3) participants who were alive and progression free at 2 years.|2 years|This endpoint is limited to patients with del(11q22.3).|||proportion of participants||90% Confidence Interval|Number
2789069|NCT00602459|Secondary|Overall Response Rates in Patients With Del(11q22.3)|Percentage of del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.|Up to 15 years|Patients with del(11q22.3) were included in this analysis.|||percentage of participants||90% Confidence Interval|Number
2789070|NCT00602459|Secondary|Overall Response Rate in Patients Without Del(11q22.3)|Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.|Up to 15 years|Patients without Del(11q22.3) were included in this analysis.|||percentage of participants||90% Confidence Interval|Number
2789071|NCT00602459|Primary|2-Year Progression Free Survival (PFS) Rate|Proportion of participants who were alive and progression free at 2 years.|2 years|Patients re-assigned to Arm C were split into two analysis groups, patients with del(11q22.3), as assessed by interphase cytogenetics and present in at least 20% of cells, and those without del(11q22.3). This endpoint is limited to patients without del(11q22.3).|||proportion of participants||90% Confidence Interval|Number
2789072|NCT00602446|Secondary|Reduction in Liver Iron Concentration After Study Drug|Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.|6 Months|All patients included in count.|||milligrams/gram||Standard Deviation|Mean
2789073|NCT00602446|Primary|Number of Patients Not Completing Treatment|Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity|6 Months|Note: 1 patient had a transient decrease in hemoglobin that required discontinuation of treatment for 2 weeks; subsequently restarted at same dose and completed therapy.|||Participants|||Number
2789074|NCT00602420|Primary|Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.|Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days.|From baseline through day 5||||(Pain Scale Score)*Days||95% Confidence Interval|Mean
2789075|NCT00602355|Secondary|Hamilton Anxiety Rating Scale (HARS)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
2789076|NCT00602355|Secondary|Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)|Measure total ranges from 1 to 5, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up||||units on a scale||Standard Deviation|Mean
2789080|NCT00602290|Secondary|Quality of Life Assessment|The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The total score is reported for items 1-14. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with higher values representing a better outcome.|Measured at Baseline and Week 16|The overall analyzed at baseline and week 16 differs due to participant drop out.|||units on a scale||Standard Deviation|Mean
2789081|NCT00602290|Primary|Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16|The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less.|Maintained response measured at Week 16||||units on a scale||Standard Deviation|Mean
2789082|NCT00602225|Secondary|Overall Survival||At five years after the last dose of clofarabine||||months||95% Confidence Interval|Median
2789083|NCT00602225|Secondary|Disease-free Survival|Number of participants who survived and were disease-free at 5 years|At five years after the last dose of clofarabine||||Participants|||Count of Participants
2789084|NCT00602225|Secondary|Efficacy|Number of Patients Surviving at Five Years|At five years after the last dose of clofarabine||||Participants|||Count of Participants
2789085|NCT00602225|Secondary|Hematologic and Non-hematologic Side Effect Profile||45 days after the last dose of clofarabine|Data not collected||||||
2789086|NCT00602225|Primary|Response Rates by Salvage Number|Number of participants in each Salvage number category who achieved a Complete Remission. Salvage number refers to whether treatment with GCLAC on this study was the pariticipant's first salvage regimen (1), second salvage regimen (2), or third or greater salvage regimen (3 or greater).|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
2789087|NCT00602225|Primary|Response Rates by Duration First Complete Remission (CR1)|Number of participants whose first Complete Remission lasted 0, 1-6, 6-12, or greater than 12 months. Only those participant who had a first CR are included in this data.|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
2789088|NCT00602225|Primary|Response Rates by Cytogenetic Risk Category and Clofarabine Dose|Number of participants under each Cytogenetic Risk Category and Clofarabine dose who achieve CR (Complete Remission = less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) or CRp (Complete Remission, but with a platelet count of less than 100,000/microL).|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
2789089|NCT00602225|Primary|Response Rates by Cytogenetic Risk Category|Number of participants who achieved Complete Remission (less than 5% blasts in the marrow and count recovery of Absolute Neutrophil Count to 1,000/microL and Platelet Count to 100,000/microL) under each cytogenetic risk category.|45 days after the last dose of clofarabine|Of the 50 patients, 4 were excluded from analysis of response: 2 patients with GVHD, 1 patient who received only 1 g/m2 ara-C, and 1 patient who did not have a marrow confirming remission status prior to beginning a preparative regimen for allogeneic HCT.|||Participants|||Count of Participants
2789090|NCT00602225|Primary|Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0||45 days after the last dose of clofarabine||||Participants|||Count of Participants
2789091|NCT00602225|Primary|Maximum Tolerated Dose of Clofarabine||45 days after the last dose of clofarabine||||mg/m^2 of clofarabine|||Number
2789092|NCT00602043|Secondary|Correlation of FES Uptake With ER Assays|Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.|Up to 6 months|Data were not collected due to variations in reporting methods for ER assays.||||||
2789093|NCT00602043|Secondary|Time to Progression|FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.|Up to 6 months||||months||Full Range|Median
2789094|NCT00602043|Secondary|Number of Participants With Clinical Benefit|"FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of clinical benefit.~Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months.~The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months)."|Up to 6 months||||Participants|||Count of Participants
2789095|NCT00602043|Primary|Best Overall Response|"Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease [per response evaluation criteria in solid tumors (RECIST, version 1.1)], size-based response criteria were used to assess response.~For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).~The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months)."|Up to 6 months||||patients with progressive disease|||Number
2789097|NCT00601965|Primary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).|56 weeks||||participants|||Number
2789098|NCT00601952|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|"The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from not at all to extremely, with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, & Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, & Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993)."|Pre, Post, Followup||||units on a scale||Standard Deviation|Mean
2789099|NCT00601926|Secondary|Safety of Bevacizumab in This Population of Patients|Grade 3 or higher toxicities according to CTCAE version 3.0|Up to 2 years||||toxicities|||Number
2789100|NCT00601926|Primary|Response Rate to Bevacizumab in This Population.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 years|Includes patients with Complete response, partial response or stable disease|||patients|||Number
2789101|NCT00601926|Primary|Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.|Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||Full Range|Median
2789102|NCT00601900|Secondary|Treatment Related Toxicity|Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm.|Up to 5 years|||||||
2789103|NCT00601900|Secondary|Time-to-treatment Failure|From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure|Up to 5 years|||||||
2789104|NCT00601900|Secondary|Site of Progression||Up to 5 years|||||||
2789105|NCT00601900|Secondary|Probability of Surviving Until 36 Months||At 36 months|||||||
2789106|NCT00601900|Secondary|Duration of Tumor Response|Defined by RECIST criteria.|From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|||||||
2789107|NCT00601900|Secondary|Overall Survival (OS)|OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|Assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||months||95% Confidence Interval|Median
2789108|NCT00601900|Secondary|Objective Response Rate|Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Assessed up to 5 years|Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment.|||percentage of participants|||Number
2789109|NCT00601900|Secondary|6 Month Progression-Free Survival Rate|The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study.|At 6 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||percentage of participants||95% Confidence Interval|Number
2789110|NCT00601900|Secondary|12 Month Progression Free Survival Rate|The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study.|At 12 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||percentage of participants||95% Confidence Interval|Number
2789126|NCT00601705|Secondary|Postoperative Adjuvant Chemoradiotherapy Feasibility|Ability to complete postoperative chemoradiotherapy. A threshold level of 65% was set and if less than this percentage completed the phase, it would be deemed unacceptable. The anticipation was that 53-patients would be evaluable for this end point.|Between 6 to 10 weeks postoperatively|All patients that went on study|||Participants|||Count of Participants
2789156|NCT00601458|Primary|Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery|Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery||||milligrams||Inter-Quartile Range|Geometric Mean
2789111|NCT00601900|Primary|Progression-free Survival|The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.|From randomization until disease progression or death whichever occurs first, assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.|||months||95% Confidence Interval|Median
2789112|NCT00601835|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Chills, Diarrhea, Fever (temperature), Headache, Malaise, Muscle weakness, Nausea, Pain in joints, Rash, and Vomiting.|0-14 days post-vaccination|Solicited safety parameters were in all enrolled and vaccinated participants ≥ 60 years of age and one third of participants 11 to 59 years of age. A subset of the intend-to-treat population.|||Participants|||Number
2789113|NCT00601835|Secondary|Post-vaccination Geometric Mean Titer (GMT) to Tetanus and Diphtheria in Participants ≥ 60 Years Vaccinated With Canadian-manufactured or US-manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.||28 Days post-vaccination|Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
2789114|NCT00601835|Primary|Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.|Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.|28 Days post-vaccination|Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.|||Percentage of participants|||Number
2789115|NCT00601796|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.|3 years|All participants|||participants|||Number
2789116|NCT00601796|Secondary|Median Overall Survival (OS)|Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.|3 years|All participants|||months||95% Confidence Interval|Median
2789117|NCT00601796|Secondary|Median Time to Progression (TTP)|"Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier."|3 years|All participants|||months||95% Confidence Interval|Median
2789118|NCT00601796|Primary|Number of Evaluable Participants With Tumor Response|Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.|3 years|14 participants with evaluable PBMCs|||participants|||Number
2789119|NCT00601731|Secondary|GMTs in Subjects Within Each Site and in Age-Matched Control Subjects|The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.|At 40 and 60 months of age|The analysis was done on MITT population|||Titers||95% Confidence Interval|Geometric Mean
2789120|NCT00601731|Secondary|Percentage of Subjects With hSBA ≥1:4|Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|The analysis was done on MITT population|||Percentages of subjects||95% Confidence Interval|Number
2789121|NCT00601731|Primary|Percentage of Subjects With hSBA ≥1:8|Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.|||Percentages of subjects||95% Confidence Interval|Number
2789122|NCT00601718|Primary|Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment||1-3 weeks post end of treatment||||Participants|||Count of Participants
2789127|NCT00601705|Secondary|Locoregional Control and Distant Metastatic Control|A distant metastatic control rate of greater than 55 % would suggest efficacy for this treatment protocol. A locoregional control rate of less than 75% would suggest inefficacy. Locoregional control (LRC) defined by recurrence at the primary site or in regional lymph nodes and distant metastatic control (DMC), defined by recurrence in a distant site.|at 3 years from on study|All participants that went on study|||Participants|||Count of Participants
2789128|NCT00601705|Secondary|Overall Survival|Percent of participants with a 3-year survival. A survival rate greater than 50% would suggest efficacy and justify further study.|at 3 years from on study|All patients that went on study|||percentage of participants|||Number
2789129|NCT00601705|Secondary|Pathological Response Rate|"Percent of participants with a clinical response:~Complete pathologic response is defined as the complete disappearance of all viable tumor in the surgical specimen.~Partial pathologic response is defined as any improvement in the pathologically determined T or N stage (without reciprocal deterioration in N or T) or a resolution of M1a disease, when compared to the pretreatment esophageal ultrasound-determined clinical stage. A partial response will not be defined based only on shrinkage of a measurable lesion unless there is improvement in the TNM stage.~Stable pathologic disease is defined as no change in the pathologically determined TNM stage when compared to the pretreatment esophageal ultrasound.~Progressive pathologic disease is defined as any increase in the T or N stage irrespective of any reciprocal improvement in N or T, or as the development of new areas of malignancy or metastases."|after completion of study at 35 weeks|Participants that complete induction therapy|||participants|||Number
2789130|NCT00601705|Secondary|Clinical Response Rate|"Percent of participants with a clinical response:~Complete clinical response is defined as the complete disappearance of all clinical evidence of tumor.~Partial clinical response is defined as any improvement in the clinically determined T or N stage (without reciprocal deterioration in N or T) or a resolution of M1a disease, when compared to the pretreatment clinical stage. A partial response will not be defined based only on shrinkage of a measurable lesion unless there is improvement in the TNM stage.~Stable clinical disease is defined as no change in the clinical TNM stage when compared to the pretreatment clinical stage.~Progressive clinical disease is defined as any increase in the T or N stage irrespective of any reciprocal improvement in N or T, or as the development of new areas of malignancy or metastases."|at 12 weeks from on study|Participants that complete induction therapy|||percentage of participants|||Number
2789131|NCT00601705|Primary|Feasibility of Induction Chemoradiotherapy as Measured by Resectability Rate|Feasibility of induction chemoradiotherapy as measured by resectability in greater than 75% of participants. The number of participants that were resectable.|at 12 weeks from on study|All subjects that went on study and received treatment|||Participants|||Count of Participants
2789132|NCT00601640|Secondary|Change in Histologic Score Diagnosis and Treatment Group|Change scores were computed by subtracting baseline histologic score from End of Study histologic score. Slides were formalin fixed. Histologic Score has been developed by this research group over the course of Grant (reference below). A standardized form captures data on the following criteria: basal or suprabasilar pleomorphism (atypia); inflammation; hyperkeratosis; parakeratosis. The atypia and inflammation were rated as: none (0), mild to moderate(1), and severe (2). The remaining criteria were rated as present (1) or absent (0). Histologic Scores were computed by adding together the codes for the histologic criteria. Higher scores reflected higher level of epidermal /dermal damage.|3 months||||units on a scale||Standard Error|Mean
2789133|NCT00601640|Primary|Safety of Combination Therapy With Topical Eflornithine Hydrochloride Ointment and Topical Diclofenac Sodium Gel Over 3-months|Adverse events were compared across three treatment groups by severity determined by the clinician. All adverse events were resolved by the end of follow up.|3 months||||participants|||Number
2789134|NCT00601640|Primary|Changes in Putrescine Over 3 Months|Putrescine is measured in nmole/g skin per biopsy. Baseline and End of Study biopsies were measured and the change was produced by subtracting baseline levels from End of Study levels. There was one baseline biopsy and one End of Study biopsy per participant.|3 months||||nmol/g skin||Standard Error|Mean
2789135|NCT00601627|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier.|baseline to 2 years|All patients were included in the analysis.|||months||95% Confidence Interval|Median
2789136|NCT00601627|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.|baseline to 2 years|Too few patients reported a confirmed response to provide meaningful information into the duration of response.||||||
2789137|NCT00601627|Secondary|Confirmed Response Rate|"A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.~A complete response is defined as the disappearance of all target and non-target lesions.~A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline.~Confirmed tumor response will be evaluated using the first 6 cycles of treatment."|baseline to 2 years|All patients were analyzed for this endpoint.|||rate of confirmed response||95% Confidence Interval|Number
2789138|NCT00601627|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression.|baseline to 2 years|All patients were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2789139|NCT00601627|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|baseline to 2 years|All patients were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2789140|NCT00601627|Primary|One Year Survival Rate|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method.|Baseline to 12 months|All patients were evaluable for this endpoint.|||proportion of patients||95% Confidence Interval|Number
2789141|NCT00601523|Secondary|Patient Rating of Convenience of Treatment Dosing|Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)|||participants|||Number
2789142|NCT00601523|Secondary|Patient Preference Regarding Treatment Dosing|Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)|||participants|||Number
2789143|NCT00601523|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)|||Percentage of participants|||Number
2789144|NCT00601523|Secondary|Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients|Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment|Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80 (patients from 248.524) or week 72 (patients from 248.636)|||Patients|||Number
2789145|NCT00601523|Secondary|L-Dopa Dose: Change From OL Baseline|Change from open-label baseline in Levodopa dose|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636)|||Patients|||Number
2789146|NCT00601523|Secondary|Number of Patients Introducing L-Dopa Medication in OL Trial|Number of patients requiring Levodopa supplementation during the study|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from FAS|||Patients|||Number
2789147|NCT00601523|Secondary|Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline|PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
2789148|NCT00601523|Secondary|Response in Patient Global Impression of Improvement (PGI-I)|"Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)|||Patients|||Number
2789149|NCT00601523|Secondary|Response in Clinical Global Impression of Improvement (CGI-I)|"Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)|||Patients|||Number
2789150|NCT00601523|Secondary|UPDRS III Total Score: Change From OL Baseline|UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
2789151|NCT00601523|Secondary|UPDRS II Total Score: Change From OL Baseline|UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
2789152|NCT00601523|Secondary|UPDRS I Total Score: Change From OL Baseline|UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
2789153|NCT00601523|Secondary|Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)|A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Patients|||Number
2789154|NCT00601523|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)|||Units of scale||Standard Deviation|Mean
2789157|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
2789158|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy by Gender.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
2789159|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
2789160|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.|||participants|||Number
2789161|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.|To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2789162|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2789163|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.|To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2789164|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2789165|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2789166|NCT00601419|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||events|||Number
2789167|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2789168|NCT00601367|Primary|Frequency of Adverse Events||28 weeks||||participants with any adverse event|||Number
2789169|NCT00601354|Other Pre-specified|Weeks of Adherence to Orlistat||Number of adherent weeks over 1 year study|Intent to treat|||week of adherence to orlistat||Standard Deviation|Mean
2789170|NCT00601354|Secondary|Binge Frequency|frequency of objective binge days over prior 28 days|3 months: Measured from pre to post treatment|Intent to treat|||% change objective binge days||Standard Deviation|Mean
2789171|NCT00601354|Primary|Weight Loss|Change in weight in lbs from per to post treatment|3 months: Measured from pre to post treatment|Used intent-to-treat analysis|||lbs||Standard Deviation|Mean
2789706|NCT00595959|Secondary|Patients With >50% Stenosis Measured by Duplex Ultrasound|Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).|Through 12 Month|per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months|||percent of patients|||Number
2789172|NCT00601250|Secondary|2 Hour Post−Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24|This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Least Squares Mean
2789173|NCT00601250|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Mean
2789174|NCT00601250|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789175|NCT00601250|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789176|NCT00601250|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789177|NCT00601250|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789178|NCT00601250|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24.|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
2789179|NCT00601250|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789180|NCT00601250|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789181|NCT00601250|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789182|NCT00601250|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2789183|NCT00601250|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789184|NCT00601250|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789185|NCT00601250|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789380|NCT00599924|Secondary|CL/F of Free Platinum, Total Platinum, and 5-FU|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|CL/F was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
2789186|NCT00601250|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2789187|NCT00601172|Secondary|Time to First Emetic Event|Time to first emetic event was defined as the length of time from initiation of oxaliplatin until the time of first emetic event. Participants withdrawing prematurely from the study without having experienced an emetic event were assumed to have done so and the time of emetic event was set to 0 hours. The first quartile for time to emetic event was evaluated when 25th percentile of participants of MITT population reported emetic event. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 25th percentile of participants reported emetic event at the end of the 120 hour time period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).|0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Hours||Inter-Quartile Range|Median
2789188|NCT00601172|Secondary|Time to First Anti-emetic Rescue Medication|Time to first rescue medication was defined as the length of time from initiation of oxaliplatin till the first reported use of a rescue medication. Participants withdrawing prematurely during the 120 hour assessment period without having received a rescue medication were assumed to have done so and the time of rescue medication was set to 0 hours. The first quartile for time to use of anti-emetic rescue medication was evaluated when 25th percentile of participants of MITT population reported use of anti-emetic rescue medication. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 25th percentile of participants reported use of anti-emetic rescue medication at the end of the 120 hour time period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).|0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Hours||Inter-Quartile Range|Median
2789189|NCT00601172|Secondary|Evaluation of Vital Signs: Mean Heart Rate|Vital sign included heart rate which was recorded at Screening, on Day 1 of each cycle immediately before start of the investigational product infusion, at the completion of the infusion, and immediately after the end of the oxaliplatin infusion, then again at each end of cycle visit. Mean heart rate is presented.|Up to End of Cycle for 6 cycles, an average of 24 days per cycle|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats/minute||Standard Deviation|Mean
2789190|NCT00601172|Secondary|Evaluation of Vital Signs: Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Vital signs assessment included DBP and SBP. SBP and DBP were recorded at Screening, on Day 1 of each cycle immediately before start of the investigational product infusion, at the completion of the infusion, and immediately after the end of the oxaliplatin infusion, then again at each end of cycle visit. Mean SBP and DBP are presented.|Up to End of Cycle for 6 cycles, an average of 24 days per cycle|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2789191|NCT00601172|Secondary|Number of Participants With Clinical Chemistry Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4|Grade shifts from Baseline were assessed as shift from any Grade to Grade 3 or Grade 4 in any cycle. Toxicities were graded according to the NCI-CTCAE, version 3.0. Grade refers to the severity of the toxicity. The NCI-CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. It was assessed on Baseline (Day 1), during Day 6-10 and end of cycle. Clinical chemistry parameters assessed were alanine amino transferase (ALT), aspartate amino transferase (AST), chloride, glucose, potassium, sodium and total bilirubin. Data has been presented for the number of participants with chemistry toxicity grade shifts from Baseline to toxicity grade 3 and 4 for all cycles in a consolidated format.|Up to Day 24|Safety Population.|||Participants|||Count of Participants
2789192|NCT00601172|Secondary|Number of Participants With Hematology Toxicity Grade Shifts From Baseline to Toxicity Grade 3 and 4|Grade shifts from Baseline were assessed as shift from any Grade to Grade 3 or Grade 4 in any cycle. Toxicities were graded according to the National Cancer Institute common toxicity criteria for adverse events (NCI-CTCAE), version 3.0. Grade refers to the severity of the toxicity. The NCI-CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. It was assessed on Baseline (Day 1), during Day 6-10 and end of cycle. Hematology parameters assessed were hematocrit, hemoglobin, platelet count, total neutrophils and white blood cell count. Data has been presented for the number of participants with hematology toxicity grade shifts from Baseline to toxicity grade 3 and 4 for all cycles in a consolidated format.|Baseline (Day 1) to Day 24|Safety Population.|||Participants|||Count of Participants
2789193|NCT00601172|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|Up to 35 days|Safety Population which comprised of all participants who were randomized, and received any investigational product.|||Participants|||Count of Participants
2789377|NCT00599924|Secondary|Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI|IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.|Cycle 3 (Day 1) and Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.||||||
2789194|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Volume of Distribution (Vdss) for Casopitant|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. Vdss for casopitant is presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2789195|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Clearance (CL) for Casopitant|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. CL for casopitant is presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2789196|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Time to Maximum Observed Drug Concentration (Tmax) and Observed Elimination Half-life (t1/2) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the eCRF. Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. Tmax and t1/2 for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK parameter population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2789197|NCT00601172|Secondary|Single-dose Pharmacokinetic Parameters: Maximum Observed Drug Concentration (Cmax) for Casopitant and Metabolites GSK525060, GSK517142 and GSK631832|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the electronic case report form (eCRF). Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. (Cmax) for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK Parameter population. Only those participants available at the specified time points were analyzed.|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2789198|NCT00601172|Secondary|Single-dose Pharmacokinetic (PK) Parameters: Area Under the Curve (AUC) 0 to Infinity (0-∞), AUC 0 to t (0-t) and AUC 0 to 24 Hours (0-24) for Casopitant; AUC (0-t) and AUC (0-24) for Metabolites GSK525060, GSK517142 and GSK631832|Blood samples were obtained during Cycle 1 at the following times relative to the investigational product administration: pre-dose, end of infusion, 0.5, 1, 3, 5, 8, 12, 16, and 24 hours after the end of infusion. A final PK sample was collected between 30 and 48 hours after the investigational product infusion had completed. The actual time each sample was collected was captured to the nearest minute in the electronic case report form (eCRF). Following unblinding, only those participants who had been randomized to receive casopitant were included in the PK analyses. AUC(0-∞), AUC(0-t), AUC(0-24) for casopitant and metabolites GSK525060, GSK517142 and GSK631832 are presented.|Pre-dose, end of infusion and 0.5, 1, 3, 5, 8, 12, 16, 24 hours after the end of infusion|PK parameter population: All participants who consented to PK sampling, who were randomized to IV casopitant and for whom a PK sample was obtained and analyzed, and from whom sufficient data was available to calculate casopitant PK parameters on an as-treated basis. Only those participants with data available at indicated time points were analyzed.|||Hour*nanogram/milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2789199|NCT00601172|Secondary|Severity of Nausea in the Overall, Acute, and Delayed Phases of Cycle 1 Assessed by a Categorical Scale|Participants were asked to rate the level of nausea he/she experienced over the previous (24 hours for a period of 120 hours following the administration of MEC), by placing a vertical mark on a VAS. The severity of nausea and was calculated by using a 0 - 100 VAS where 0 = No Nausea and 100 = Nausea as bad as it can be. The categorical scale assessed the participants severity of his/her nausea using the following: mild: Queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit/throw up (but not vomiting), that has significant negative effect on the daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others) and severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities. Higher scores indicated worst outcome.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Participants|||Count of Participants
2789209|NCT00601172|Secondary|Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the delayed phase of Cycle 1 are presented.|24 to 120 hours (delayed phase) in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789200|NCT00601172|Secondary|Percentage of Participants Whose Daily Life Activities Were Impacted in the Overall Phase of Cycle 1, Assessed by Functional Living Index-Emesis (FLIE) Questionnaire|FLIE questionnaire specifically addresses the impact of nausea and vomiting on daily activities (physical, social and emotional function, ability to enjoy meals). It consists of 18 items with questions divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). Each item is scored on a VAS with 7 hatch marks. The scale is anchored at 1 (Not at all) and 7 (A great deal). For questions 1,2,4,5,7,8-10,12-14,16 and 17 the final score was calculated by subtracting the initial score from 100 for questions 3,6,11,15 and 18 the final score was the one provided in the dataset. The score for the nausea domain: ([sum of nausea item scores] ÷ [Number of items answered] x 9) and for vomiting domain: ([sum of vomiting item scores] ÷ [Number of items answered] x 9). The total score was the sum of the nausea and vomiting domain scores. Higher scores indicate less impairment on daily life as a result of nausea or vomiting.|0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789201|NCT00601172|Secondary|Percentage of Participants Who Achieved Total Control, Defined as Complete Responders Who Had no Nausea|Total control was defined as no vomiting/retching, no use of rescue medication and no nausea. Percentage of participants who achieved total control or complete responders with no nausea are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789202|NCT00601172|Secondary|Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant Nausea|Complete protection was defined as no vomiting/retching, no use of rescue medication and no significant nausea. Percentage of participants who achieved complete protection or complete responders with no significant nausea are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789203|NCT00601172|Secondary|Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VAS|VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported nausea, defined as a maximum score of >= 5 mm on the VAS are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789204|NCT00601172|Secondary|Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VAS|VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported significant nausea, defined as a maximum score >= 25 mm on the VAS are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789205|NCT00601172|Secondary|Percentage of Participants Who Vomited and/or Retched|Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that is not productive of gastrointestinal contents (also known as dry heaves). If a participant took rescue medication but there was no evidence of vomiting or retching, then the participant was considered as not having vomited. Percentage of participants who vomited and/or retched during the first 120 hours of the first cycle of chemotherapy are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789206|NCT00601172|Secondary|Percentage of Participants Who Received Rescue Medication|Anti-emetic rescue medication was defined as medication that was administered specifically for the treatment of nausea and/or emesis during Days 1-6 of each cycle. The choice of rescue anti-emetic medication was left to the discretion of the investigator. Participants who required antiemetic rescue medication(s) during the 120-hour assessment period were considered treatment failures for that cycle. Percentage of participants who received rescue medication are presented.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789207|NCT00601172|Secondary|Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS)|VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS.|0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy|MITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2789208|NCT00601172|Secondary|Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase of Cycle 2 are presented.|0 to 120 hours in the second cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789219|NCT00600938|Secondary|Extension Study: The Cardiac Iron Concentration From T2* Values|Cardiac iron concentration (derived from T2* values) at baseline, Months 6, 12, 18 and 24 were summarized by descriptive statistics. The absolute change from baseline at Months 6, 12, 18 and 24 were also summarized by treatment group. Lliver iron concentration is expressed in units (mg of iron / g of liver tissue dry weight (dw)|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase|||mg Fe/g dw||Standard Deviation|Mean
2789210|NCT00601172|Secondary|Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participants who achieved a complete response in the acute phase of Cycle 1 are presented.|0 to 24 hours in the first cycle of chemotherapy|MITT Population.|||Percentage of participants|||Number
2789211|NCT00601172|Primary|Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen|Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began at the start of the administration of the oxaliplatin infusion. Percentage of participants who achieved a complete response in the overall phase (0-120 hours) are presented.|0 to 120 hours in the first cycle of chemotherapy|Modified Intent-to-Treat Population (mITT) comprised of all participants who were randomized, received any investigational product and had oxaliplatin administered.|||Percentage of participants|||Number
2789212|NCT00601146|Primary|To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.|In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded|3 years|Enrolled patients who underwent low-dose CCT screening- number of lung cancer diagnosed|||participants|||Number
2789213|NCT00601107|Secondary|Percentage of Participants With Static Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination|Static PGA of psoriasis is scored on a 5-point scale (0 = clear to 4 = severe), reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. Clear (erythema: no, scale: no, induration: no thickness); Almost Clear (erythema: light pink, scale: fine scale, induration: barely palpable); Mild (erythema: light red, scale: coarse scale on most lesions, induration: slight but visible elevation, indistinct edges); Moderate (erythema: red, scale: coarse adherent scale predominates, induration: moderate elevation with edges); and Severe (erythema: dark red to purple, scale: thickened adherent scale, induration: marked thickness distinct and pronounced edges). Percentage of participants with static PGA score of clear or almost clear are reported.|Week 12 or Early Termination, Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.|||percentage of participants|||Number
2789214|NCT00601107|Secondary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.|||percentage of participants|||Number
2789215|NCT00601107|Primary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 12 or Early Termination|The Full Analysis Set (FAS) included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.|||percentage of participants|||Number
2789216|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, time to reach maximum plasma concentration (Tmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||(h)||Inter-Quartile Range|Median
2789217|NCT00600938|Secondary|Extension Study: Change in Serum Ferritin From Baseline by Month|Serum ferritin values was summarized by descriptive statistics. Absolute value and the absolute change from baseline in serum ferritin by month was provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase|||ug/L||Standard Deviation|Mean
2789218|NCT00600938|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|Results of liver iron content (LIC) measurements by MRI was summarized by descriptive statistics. The absolute value and the absolute change from baseline in LIC at Months 6, 12, 18 and 24 were provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase|||mg Fe/g dw||Standard Deviation|Mean
2789220|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI)|Cardiac function endpoints (LVMI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites|||gram/m^2||Standard Deviation|Mean
2789221|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|Cardiac function endpoint (LVEDVI ) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites|||mL/m^2||Standard Deviation|Mean
2789222|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|Cardiac function endpoints (LVESVI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.|||mL/m^2||Standard Deviation|Mean
2789223|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF)|Cardiac function endpoints (LVEF) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.|||Percent||Standard Deviation|Mean
2789224|NCT00600938|Secondary|Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment|The measured T2* values, the ratio (post-baseline / baseline T2*) at Month 6, 12, 18 and 24 was summarized for FAS population along with two-sided 95% CIs. The geometric means of the ratio was presented for all treatment groups|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase.|||Ratio||95% Confidence Interval|Geometric Mean
2789225|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. For trough concentration assessments, a 2-mL blood sample was to be taken on arrival at the study site, i.e. prior to the patient receiving the daily deferasirox dose (pre-dose blood sample). A second 2-mL blood sample was to be taken 2 hours later (post-dose sample). At all other visits (Visits 3 - 14), a pre-dose sample was to be taken. For PK profile assessments, 3 blood samples were taken after 1, 2, and 4 hours post-dose in addition to the 2-mL pre-dose|Month 1 and month 2 (pre-dose, 1,2 and 4 hours post-dose)|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||(umol/L)||Standard Deviation|Mean
2789226|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, maximum plasma concentration (Cmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||umol/L||Standard Deviation|Mean
2789227|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, area under the plasma concentration-time curve for a dosing interval (AUCtau)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).|||(h.ng/mL)||Standard Deviation|Mean
2789228|NCT00600938|Secondary|Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period.|Number of patients with adverse events, serious adverse events and death|12 Month|Safety Set (SS) consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. Treatment received is defined as first study drug administered|||Participants|||Number
2789229|NCT00600938|Secondary|Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine|The number of patients withdrawn from the study due to LVEF <50%, T2* <6 ms or significant decreases in T2* ≥ 33% from baseline was provided per treatment group.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Participants|||Number
2789230|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI)|An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||gram/m^2||Standard Deviation|Mean
2789231|NCT00600938|Secondary|Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Percent||Standard Deviation|Mean
2789232|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|An absolute change from baseline in LVESVI after 6 and 12 months treatment with deferasirox and DFO was summarized. Changes in cardiovascular magnetic resonance (CMR) measured left ventricular end systolic after 6 and 12 months treatment. Left ventricular (LV) end-systolic volume indexed to body surface area (ESVI) is a simple yet powerful echocardiographic marker of LV remodeling that can be measured easily. Left ventricular (LV) end-systolic volume (ESV) has been shown to be an important determinant of survival after myocardial infarction (MI)|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Milliliter||Standard Deviation|Mean
2789233|NCT00600938|Secondary|Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment|Summary statistics of T2* ratio Month 6/baseline|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Ratio||95% Confidence Interval|Geometric Mean
2789234|NCT00600938|Secondary|Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations|||Percent||Standard Deviation|Mean
2789235|NCT00600938|Secondary|Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 12 months treatment with deferasirox and compared to.DFO was tested using an analysis of covariance model including baseline left ventricular ejection fraction (LVEF) as a covariate.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.|||Percent||Standard Error|Least Squares Mean
2789236|NCT00600938|Primary|Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment|Non- inferiority in efficacy of deferasirox compared to deferoxamine (DFO) in treating cardiac iron overload as measured by T2*. A non-inferiority margin of 0.9 (90%) was applied. Due to limitations in performing heart biopsies, T2* (T2 star), a Magnetic Resonance (MR) relaxation parameter expressed in milliseconds, as is an important tool to noninvasively quantify cardiac iron concentration. Studies have shown that myocardial T2* evaluations may predict cardiac events, e.g., impaired (<56%) left ventricular ejection fraction (LVEF) is prevalent among patients with low T2*: found in 62% of patients with T2*<8 ms; 20% with T2* of 8-12 ms; and in 5% with T2* >12 ms (Tanner 2006)|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.|||Millisecond||95% Confidence Interval|Geometric Mean
2789237|NCT00600886|Secondary|Summary of Prolactin Levels After Crossover|Prolactin (PRL) levels. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Extension baseline was defined as last measurement prior to the start of crossover treatment.|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||μg/L||Standard Deviation|Mean
2789238|NCT00600886|Secondary|Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover|AcroQoL total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Total scores range from 0 to 100. Higher scores represent better quality of life.|Extension baseline, months 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||scores on a scale||Standard Deviation|Mean
2789267|NCT00600821|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood|RNA expression profiles of genes which were associated with tumor growth, angiogenesis and metastases were collected and correlated with efficacy.|Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1|Data was not generated but sample was collected for banking and moved to a separate exploratory research database for future research.||||||
2789239|NCT00600886|Secondary|Ring Size After Crossover|Ring size (based on jeweler's finger gauge). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). BL = baseline, LH = left hand, RH = right hand, CO = crossover|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received. In the extension baseline, no participant had ring size on their right hand measured at the 5th digit, hence no data.|||ring size||Standard Deviation|Mean
2789240|NCT00600886|Secondary|Severity Scores of Acromegaly Symptoms After Crossover|"Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia).~Symptoms were scored from 0 (no symptom) to 4 (very severe). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over)."|Extension baseline, month 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||scores on a scale||Standard Deviation|Mean
2789241|NCT00600886|Secondary|Change From Extension Baseline in Tumor Volume After Crossover|"Percentage change from extension baseline in tumor volume (assessed by pituitary MRI).~Extension baseline was defined as last assessment prior to the administration of the new treatment after crossover. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over)."|Extension baseline, months 6, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||mm^3||Standard Deviation|Mean
2789242|NCT00600886|Secondary|Summary of Mean GH Values After Crossover|Mean GH levels (based on a 5-point profile over 2 hours). Extension baseline was defined as last measurement prior to the start of crossover treatment. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over).|Extension baseline, months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||μg/L||Standard Deviation|Mean
2789243|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1 After Crossover|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||Percentage of participants||95% Confidence Interval|Number
2789244|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover|Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile). Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|CAS: All patients whose first dose in the extension is different from the first dose in the core. Patients were analyzed according to the crossover treatment received.|||Percentage of participants||95% Confidence Interval|Number
2789245|NCT00600886|Secondary|Change From Baseline in Tumor Volume|Percentage change from baseline in tumor volume (assessed by pituitary MRI). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, months 6, 12, 19, 25|Full Analysis Set: All patients who were randomized into the study.|||mm^3||Standard Deviation|Mean
2789246|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the FAS. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover.|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
2789247|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).~Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included). Denominator for time points up to Month 12 is the Full Analysis Set. Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover."|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
2789286|NCT00600756|Secondary|Number of Participants Using Antidepressants at Month 12 in the ITT Population|"The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup N06-Antidepressants."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789248|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover|Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1. Analysis was based on data after crossover (i.e., included data from blinded extension phase collected after the crossover time point for patients who crossed over). Denominator for all time points is the Crossover Analysis Set (CAS).|Months 3, 6, 9, 12 after crossover|"Crossover Analysis Set (CAS): All patients whose first dose in the extension is different from the first dose in the core.~Patients were analyzed according to the crossover treatment received."|||Percentage of participants||95% Confidence Interval|Number
2789249|NCT00600886|Secondary|Octreotide Trough Concentrations by Incident Dose|Octreotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.|Months 1 - 12|PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 30 mg dose in Months 1, 2 and 3, hence no data.|||ng/mL||Standard Deviation|Mean
2789250|NCT00600886|Secondary|Pasireotide Trough Concentrations by Incident Dose|"Pasireotide LAR trough concentrations by incident dose (last dose administered prior to PK sample collection). PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28±2 days window were excluded.~5 patients with evaluable PK data in the pasireotide arm received erroneously 20 mg pasireotide LAR at baseline."|Months 1 - 12|PK analysis set: All patients with at least one LAR injection and one post-dose trough concentration data in core phase (up to month 12). No participants took the 60 mg dose in Months 1, 2 and 3, hence no data.|||ng/mL||Standard Deviation|Mean
2789251|NCT00600886|Secondary|Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)|"The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.~Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included)."|Up to 26 months|Full Analysis Set: All patients who were randomized into the study.|||Weeks||95% Confidence Interval|Median
2789252|NCT00600886|Secondary|Summary of Prolactin Levels|Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||μg/L||Standard Deviation|Mean
2789253|NCT00600886|Secondary|Health-related Quality-of-life as Measured by the AcroQoL Questionnaire|Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||Score on a scale||Standard Deviation|Mean
2789254|NCT00600886|Secondary|Ring Size|Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||ring zize||Standard Deviation|Mean
2789255|NCT00600886|Secondary|Severity Scores of Acromegaly Symptoms|Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 12, 25|Full Analysis Set: All patients who were randomized into the study.|||scores on a scale||Standard Deviation|Mean
2789256|NCT00600886|Secondary|Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )|Time to first response for patients achieving a reduction of mean GH level to < 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Up to 26 months|Full Analysis Set: All patients who were randomized into the study.|||Weeks||95% Confidence Interval|Median
2789257|NCT00600886|Secondary|Summary of Mean GH Values|Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).|Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||μg/L||Standard Deviation|Mean
2789287|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Days||Standard Deviation|Mean
2789258|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.~Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., included data from both blinded core & ext. phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included.)"|Months 3, 6, 9, 12, 16, 19, 22, 25|Full Analysis Set: All patients who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
2789259|NCT00600886|Secondary|Percentage of Participants With Normalization of IGF-1|Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|12 Months|Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing IGF-1 levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as nonresponders.|||Percentage of participants||95% Confidence Interval|Number
2789260|NCT00600886|Secondary|Change From Baseline in Tumor Volume at 12 Months|Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|Baseline, 12 Months|Full Analysis Set (FAS): All patients who were randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization.|||mm^3||Standard Deviation|Mean
2789261|NCT00600886|Secondary|Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L|"Percentage of participants with a reduction of mean GH levels to < 2.5μg/L (based on a 5-point 2-hour profile).~Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated."|12 Months|FAS: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH levels at Month 12 were imputed using data obtained at or after Month 6 by the LOCF (last observation carried forward) method; otherwise, Pts were considered as non-responders.|||Percentage of participants||95% Confidence Interval|Number
2789262|NCT00600886|Primary|Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1|"Percentage of participants with a reduction of mean GH levels to <2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.~Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated."|12 months|Full Analysis Set: All patients (Pts) who were randomized into the study. Pts were analyzed according to the treatment they were assigned to at randomization. Missing mean GH and/or IGF-1 levels at M12 were imputed using data obtained at or after M6 by the last observation carried forward method; otherwise, Pts were considered as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2789263|NCT00600821|Other Pre-specified|Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype|UGT1A1 an enzyme of the glucuronidation pathway that transforms small lipophilic molecules, such as steroids, bilirubin, hormones, and drugs, into water-soluble, excretable metabolites.|Baseline (Day 1 of Cycle 1)|Data was reported in listings but not summarized due to statistical constraints.||||||
2789264|NCT00600821|Secondary|Plasma Concentration of Soluble Proteins|Plasma concentrations of soluble proteins (soluble- stem-cell factor receptor (sKIT) vascular endothelial growth factor [VEGF], and vascular endothelial growth factor receptor-2 [VEGFR2], VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.|||Picogram/mL (pg/mL)||Standard Deviation|Mean
2789265|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.|||Flourescent Intensity Unit (FIU)||Standard Deviation|Mean
2789266|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood: Total CEC|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.|||Cells/milliliter (cells/mL)||Standard Deviation|Mean
2789268|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
2789269|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhoea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
2789270|NCT00600821|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1|||||||
2789271|NCT00600821|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
2789272|NCT00600821|Secondary|Percentage of Participants With Objective Response (OR)|OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all lesions (target and/or non target) and no appearance of new lesions. PR: at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, without progression of non target lesions and no appearance of new lesions.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2789273|NCT00600821|Secondary|Overall Survival (OS)|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the first randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2789274|NCT00600821|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2789275|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 231 evaluable men, 111 were missing individual AE “Sexual Dysfunction” data”.~Risperidone: Out of 231 evaluable men, 106 were missing individual AE “Sexual Dysfunction” data”."|||Participants|||Number
2789309|NCT00600704|Primary|Mean Number of Packed Red Cells Units Transfused During Hospital Stay||20 months|Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass|||packed red cells units|Participants|95% Confidence Interval|Mean
2789276|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 160 evaluable women, 73 were missing individual AE “Hyperprolactinaemia” data.~Risperidone: Out of 171 evaluable women, 74 were missing individual AE “Hyperprolactinaemia” data”."|||Participants|||Number
2789277|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
2789278|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population|The normal range for men is 0 to 14, and for women is 0 to 24.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||ng/mL||Standard Deviation|Mean
2789279|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
2789280|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population|Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Events|||Number
2789281|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
2789282|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
2789283|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).|||Participants|||Number
2789284|NCT00600756|Secondary|The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789285|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population|Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789310|NCT00600613|Primary|"Number of Participants Eligible for Cone Beam Tumor Localization"|"Assess the feasibility of using a new imaging technique called cone beam imaging to localize a liver tumor immediately prior to external beam radiotherapy."|Up to 2 hours||||participants|||Number
2789288|NCT00600756|Secondary|Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population|Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.|Month 12|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789289|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population|All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789290|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population|"Workers and students are defined from the modified vocational status index excluding subjects Retired or Unemployed, whether or not expected to work."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Days||Standard Deviation|Mean
2789291|NCT00600756|Secondary|To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State|Stable State was defined as having the same status in occupational and residential status as at Baseline.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants with stable state|||Number
2789292|NCT00600756|Secondary|Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.|The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789293|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population|Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.|12 months|The Reported population is participants who showed relapse over time, from baseline to Month 12.|||Participants|||Number
2789294|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789295|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score|For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Deviation|Mean
2789296|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).|For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789297|NCT00600756|Secondary|The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population|Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Participants|||Number
2789298|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789299|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789300|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789301|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789302|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.|||Scores on a scale||Standard Error|Least Squares Mean
2789303|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).|||Scores on a scale||Standard Error|Least Squares Mean
2789304|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).|||Scores on a scale||Standard Error|Least Squares Mean
2789305|NCT00600756|Primary|Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score|The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)|6 months|For Per Protocol at Month 6 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (169) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (160).|||Participants|||Number
2789306|NCT00600743|Secondary|Sickness Report|"Response to question How sick do you feel measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)"|25-30 min after drug or placebo||||mm||Standard Error|Mean
2789307|NCT00600743|Secondary|Fullness Rating|"rating of How full do you feel by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable)."|25-30 min after taking drug||||mm||Standard Error|Mean
2789308|NCT00600743|Primary|Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions|Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions|25-30 min after taking drug|Subjects had to complete all trials of the protocol successfully|||grams||Standard Error|Mean
2789312|NCT00600353|Primary|Overall Emetic Response|Clinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.|At leaset 24 hours to more than 72 hours after chemotherapy||||Participants|||Count of Participants
2789313|NCT00600353|Primary|Overall Emetic Response: Extended|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications.~Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications.~Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5."|72 hours after chemotherapy||||Participants|||Count of Participants
2789314|NCT00600353|Primary|Overall Emetic Response: Delayed|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications.~Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications.~Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5."|24 to 72 hours after chemotherapy||||Participants|||Count of Participants
2789315|NCT00600353|Primary|Overall Emetic Response: Acute|"Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications.~Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications.~Failure - >5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5."|24 hours after chemotherapy||||Participants|||Count of Participants
2789316|NCT00600340|Secondary|Duration of Response (PP Population)|Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR).|Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.|PP population restricted to patients who experienced a partial or complete response|||months||95% Confidence Interval|Median
2789317|NCT00600340|Secondary|Duration of Response (ITT Population)|Duration of response (DR) was defined as time from date of first occurrence of any response (complete response (CR) or partial response (PR)) until the occurrence of progression of disease or death. Patients with response who neither progressed nor died were censored at the date of their last tumor assessment. Median DR, associated stratified Hazard Ratio (HR).|Time from first occurrence of CR or PR until disease progression, death or study closure, whichever occurred first, assessed up to 3.4 years after occurrence of response.|ITT population restricted to patients who experienced a partial or complete response|||months||95% Confidence Interval|Median
2789318|NCT00600340|Secondary|Time to Response (PP Population)|Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported.|Time from randomization until occurrence of response, assessed up 1.7 years|PP population, median not reached|||Participants|||Count of Participants
2789319|NCT00600340|Secondary|Time to Response (ITT Population)|Time to response (TR) was defined as time from randomization until occurrence of response (complete response (CR) or partial response (PR)) according to RECIST criteria. Patients without response were censored after the longest time to response observed in any patient. Median TR, associated stratified Hazard Ratio (HR). Since the median TR was not observed, the number of subjects with a response at given timepoints were reported.|Time from randomization until occurrence of response, assessed up 1.7 years|ITT population, median not reached|||Participants|||Count of Participants
2789320|NCT00600340|Secondary|Time to Treatment Failure (PP Population)|Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR).|From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years|PP population|||months||95% Confidence Interval|Median
2789321|NCT00600340|Secondary|Time to Treatment Failure (ITT Population)|Time to treatment failure (TTF) was defined as time from first drug intake to progression, death or withdrawal from study treatment, whichever occurred first. Patients without an event were censored at the date of the last tumor assessment or last treatment administration, whichever occurred last. Median TTF, associated stratified Hazard Ratio (HR).|From first drug intake to progression, death or withdrawal from study treatment or study closure (whichever occurred first), assessed up to approximately 4.5 years|ITT population|||months||95% Confidence Interval|Median
2789322|NCT00600340|Secondary|Progression Free Survival (PP Population)|Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR).|Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.|PP population|||months||95% Confidence Interval|Median
2789402|NCT00599924|Secondary|Minimum Plasma Concentration (Cmin) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
2789323|NCT00600340|Secondary|Progression Free Survival (ITT Population)|Progression Free Survival (PFS) is defined as time from randomization to date of documented progression or date of death due to any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients who were randomized and had no post-baseline tumor assessment were censored on the day of randomization. Median PFS, associated stratified Hazard Ratio (HR).|Time from the date of randomization to disease progression, death or censoring (whichever occurred first), assessed up to approximately 5 years.|ITT population|||months||95% Confidence Interval|Median
2789324|NCT00600340|Secondary|Unconfirmed Objective Response Rate and Disease Control Rate (PP Population)|Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|PP population|||Participants|||Count of Participants
2789325|NCT00600340|Secondary|Unconfirmed Objective Response Rate and Disease Control Rate (ITT Population)|Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment.|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|ITT population|||Participants|||Count of Participants
2789326|NCT00600340|Secondary|Objective Response Rate and Disease Control Rate (PP Population)|Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|PP population|||Participants|||Count of Participants
2789327|NCT00600340|Secondary|Objective Response Rate and Disease Control Rate (ITT Population)|Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response. Disease control rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|ITT population|||Participants|||Count of Participants
2789328|NCT00600340|Secondary|Unconfirmed Best Overall Response (PP Population)|The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment.|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|PP population|||Participants|||Count of Participants
2789329|NCT00600340|Secondary|Unconfirmed Best Overall Response (ITT Population)|The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase. Complete and partial response in this summary did not require a confirmation by a second tumor assessment.|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|ITT population|||Participants|||Count of Participants
2789330|NCT00600340|Secondary|Best Overall Response (PP Population)|The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|Per protocol population|||Participants|||Count of Participants
2789331|NCT00600340|Secondary|Best Overall Response (ITT Population)|The best overall response according to the RECIST criteria is the best response recorded from the start of the treatment until disease progression/recurrence or within 28 days of last intake of study medication in the Study Treatment Phase|Up to disease progression or up to 28 days after last intake of study medication, assessed up to approximately 5 years.|Intent-to-Treat population|||Participants|||Count of Participants
2789332|NCT00600340|Secondary|Observation Time (ITT Population)|Median observation time estimated with reverse Kaplan-Meier methods. Observation time (in months) is defined as time from randomization to the day the patient was last confirmed to be alive. In case of patient deaths the time was censored at the day of death.|Up to approximately 6 years|Intention-to-Treat population|||months||95% Confidence Interval|Median
2789333|NCT00600340|Primary|Overall Survival (ITT Population)|Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 50% of information was 0.0014. Alpha spent at final analysis after 99% of information was 0.0250.|Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years|Intent-to-Treat Population (ITT)|||months||95% Confidence Interval|Median
2789403|NCT00599924|Secondary|Time to Cmax (Tmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
2789334|NCT00600340|Primary|Overall Survival (PP Population)|Overall survival (OS) defined as time from randomization to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. OS was analyzed at two looks, one interim look and the final analysis. Due to group sequential testing, the overall significance level alpha = 0.025 was spent on both looks according to Lan-DeMets spending method with O'Brien-Fleming-type boundaries. Alpha spent at Interim after 47% of information was 0.0010. Alpha spent at final analysis after 99% of information was 0.0250.|Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years|Per Protocol Population (PP)|||months||95% Confidence Interval|Median
2789335|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2789336|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2789337|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), >=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2789338|NCT00600171|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2789339|NCT00600171|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2789340|NCT00600171|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2789341|NCT00600171|Secondary|Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2789342|NCT00600171|Secondary|Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2789343|NCT00600171|Secondary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, >=40% to <=65%; Upper stratum: FEV1 percent predicted, >=65% to <=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.|Baseline and Day 28|ITT Population. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used. Only those participants with available data (using LOCF) at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2789344|NCT00600171|Primary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline and Day 28|ITT Population: all participants who were randomized to treatment and received at least one dose of study medication. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used.|||Liters||Standard Error|Least Squares Mean
2789345|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||units on a scale||Standard Deviation|Mean
2789346|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||units on a scale||Standard Deviation|Mean
2789347|NCT00600119|Secondary|Change From Baseline in SBMs/Week Across the 28-day Double-blind Period|Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||Number of SBMs/week||Standard Deviation|Mean
2789348|NCT00600119|Primary|Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1|Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.|Days 1 through 7|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).|||Number of SBMs/week||Standard Deviation|Mean
2789378|NCT00599924|Secondary|Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).|Cycle 3 (Day 1), Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.||||||
2789349|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Stress Induced ST Segment Depression)|"Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.~In electrocardiography, the ST segment connects the QRS complex and the T wave and has duration of 80 to 120 ms. It should be essentially level with the PR and TP segment. The normal ST segment has a slight upward concavity. Flat, downsloping, or depressed ST segment may indicate coronary ishcemia. Positive treadmill exercise stress test (>1.0 mm horizontal / downsloping or >1.5 upsloping ST segment depression measured 0.08 msec after the J point)."|Exit (12 weeks)|Exercise stress testing at exit (12 weeks) by treatment|||mm||Standard Deviation|Mean
2789350|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Exercise Induced ST Segment Depression)|"Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.~In electrocardiography, the ST segment connects the QRS complex and the T wave and has duration of 80 to 120 ms. It should be essentially level with the PR and TP segment. The normal ST segment has a slight upward concavity. Flat, downsloping, or depressed ST segment may indicate coronary ishcemia. Positive treadmill exercise stress test (>1.0 mm horizontal / downsloping or >1.5 upsloping ST segment depression measured 0.08 msec after the J point)."|Baseline|Exercise stress testing at baseline by treatment|||mm||Standard Deviation|Mean
2789351|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Metabolism Equivalents)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.|Exit (12 weeks)|Exercise stress testing at exit (12 weeks) by treatment|||metabolism equivalents||Standard Deviation|Mean
2789352|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (Metabolism Equivalents)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.|Baseline|Exercise stress testing at baseline by treatment|||metabolism equivalents||Standard Deviation|Mean
2789353|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (METs)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. A MET is defined as the resting metabolic rate, that is, the amount or oxygen consumet at rest, sitting quietly in a chair, approximately 3.5 ml O2 / kg / min (1.2 kcallmin for a 70-kg person). As such, work at METs requires twice the resting metabolism or 7.0 ml O2/kg/min, and so on.|Exit at 12 weeks|Exercise stress testing at exit (12 weeks) by treatment|||metabolism equivalents||Standard Deviation|Mean
2789354|NCT00600106|Primary|Inducible Myocardial Ischemia|Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-[average of rest and recovery periods]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio >20% from rest, and a lower value is considered indicative of greater ischemia.|12 weeks|Among the 35 women, 28 baseline and 26 exit MRS results were technically adequate for spectral analyses with rest, handgrip exercise, and recovery spectra. A total of 24 women (13 drug, 11 placebo) had both baseline and exit P31's.|||percent change in PCR/ATP ratio||Standard Deviation|Mean
2789355|NCT00600106|Secondary|Quality of Life - Health Survey|"Quality of life assessed by cardiac symptoms and psychological questionnaires (SF 36 scale - Short Form Health Survey) The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.~Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|12 weeks|SF-36 scale at exit by treatment|||units on a scale||Standard Deviation|Mean
2789356|NCT00600106|Secondary|Quality of Life - Health Survey|"Quality of life assessed by cardiac symptoms and psychological questionnaires (SF 36 scale - Short Form Health Survey) The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.~Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Baseline|SF-36 scale at baseline by treatment|||units on a scale||Standard Deviation|Mean
2789357|NCT00600106|Secondary|Quality of Life - Menopause Symptoms|Quality of life assessed by menopausal symptoms and psychological questionnaires|12 weeks|Menopause Symptoms at exit by treatment|||percent of participants|||Number
2789358|NCT00600106|Primary|Endothelial Dysfunction (FMD)|"Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of vasomotor function.~Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter [diameter after cuff deflation - baseline diameter / baseline diameter) x 100]."|12 weeks|Brachial artery reactivity testing at study exit by treatment|||percentage of pre-stimulus diameter||Standard Deviation|Mean
2789359|NCT00600106|Secondary|Quality of Life - Menopause Symptoms|Quality of life assessed by menopausal symptoms and psychological questionnaires|Baseline|Menopause Symptoms at baseline by treatment|||percent of participants|||Number
2789360|NCT00600106|Primary|Endothelial Dysfunction (FMD)|"Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of endothelial dysfunction.~Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter [diameter after cuff deflation - baseline diameter / baseline diameter) x 100]."|Baseline|Brachial artery reactivity testing at baseline by treatment|||percentage of pre-stimulus diameter||Standard Deviation|Mean
2789361|NCT00600106|Secondary|Physical Functional Disability - Functional Capacity (METs)|Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. A MET is defined as the resting metabolic rate, that is, the amount or oxygen consumet at rest, sitting quietly in a chair, approximately 3.5 ml O2 / kg / min (1.2 kcallmin for a 70-kg person). As such, work at METs requires twice the resting metabolism or 7.0 ml O2/kg/min, and so on.|Baseline|Exercise stress testing at baseline by treatment|||metabolism equivalents||Standard Deviation|Mean
2789362|NCT00600106|Primary|Inducible Myocardial Ischemia|Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-[average of rest and recovery periods]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio >20% from rest, and a lower value is considered indicative of greater ischemia.|Baseline|Among the 35 women, 28 baseline and 26 exit MRS results were technically adequate for spectral analyses with rest, handgrip exercise, and recovery spectra. A total of 24 women (13 drug, 11 placebo) had both baseline and exit P31's.|||percent changed in PCR/ATP ratio||Standard Deviation|Mean
2789363|NCT00600080|Primary|Subjective Lens Comfort|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Least Squares Mean
2789364|NCT00600080|Secondary|Optimum Lens Fit|Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.|Baseline, 1-week, 2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||participants|||Number
2789365|NCT00600080|Secondary|Subject-reported Overall Product Performance|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Analyzed subjects were those who were enrolled and randomized to a study arm.|||units on a scale||Standard Error|Least Squares Mean
2789366|NCT00600080|Primary|Visual Acuity|Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.|2-week|Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.|||logMAR scale||Standard Deviation|Mean
2789367|NCT00600067|Secondary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
2789368|NCT00600067|Primary|HbA1c Change From Baseline Week 0 to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
2789369|NCT00600028|Secondary|Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Visual Analog Scale of Cough and the St. George Respiratory Questionnaire.|"The secondary endpoint, suppression of cough was measured by the visual analog scale of cough (VAS) was significantly lower during treatment with thalidomide than placebo.~Secondary endpoints were Cough VAS - the visual analog scale of cough evaluates the severity of cough in patients with IPF.~Visual analog scale of cough ranges from 0 to 100 (0 is considered the best).~St. George Respiratory Questionnaire helps to evaluate cough-specific and respiratory quality of life in patients with IPF.~St. George Respiratory Questionnaire score ranges from 0 to 100 (0 is considered the best)."|6 months|All participants who received the interventions and completed all study visits were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2789370|NCT00600028|Primary|Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire.|"The primary endpoint, suppression of cough was measured by the Cough Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life.~CQLQ consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life.~CQLQ scale ranges from 28 to 112 ( The lower the value, the higher the quality of life, 28 is considered the best)."|6 months|All participants who received the interventions and completed all study visits were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2789371|NCT00600015|Secondary|Overall Survival (OS)||18 months||||Months||95% Confidence Interval|Median
2789372|NCT00600015|Secondary|6-month PFS||6 months|||||||
2789373|NCT00600015|Secondary|Duration of Response||18 months|||||||
2789374|NCT00600015|Secondary|Disease Control Rate (DCR)||18 months|||||||
2789375|NCT00600015|Primary|Progression Free Survival (PFS)||18 months||||Months||95% Confidence Interval|Median
2789376|NCT00600015|Primary|Overall Objective Response Rate (ORR)||18 months||||Percent||95% Confidence Interval|Number
2789381|NCT00599924|Secondary|T1/2 of Free Platinum, Total Platinum, and 5-FU|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|T1/2 was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
2789382|NCT00599924|Secondary|Cmax of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|Cmax of 5-FU was not calculated.||||||
2789383|NCT00599924|Secondary|Area Under the Curve (AUC) of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|AUC for 5-FU was not calculated.||||||
2789384|NCT00599924|Secondary|Steady State Clearance (CLss) of 5-FU|CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||L/hr||Standard Deviation|Mean
2789385|NCT00599924|Secondary|Steady State Concentration (Css) of Fluorouracil (5-FU)|Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
2789386|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
2789387|NCT00599924|Secondary|Tmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
2789388|NCT00599924|Secondary|Cmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
2789389|NCT00599924|Secondary|T1/2 for Free Platinum|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Standard Deviation|Mean
2789390|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
2789391|NCT00599924|Secondary|Tmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
2789392|NCT00599924|Secondary|Cmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
2789393|NCT00599924|Secondary|T1/2 of SU-012662 (Sunitinib's Metabolite)|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for SU-012662 was not calculated due to short observation time.||||||
2789394|NCT00599924|Secondary|CL/F of SU-012662 (Sunitinib's Metabolite)|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|CL/F was not calculated for SU-012662.||||||
2789395|NCT00599924|Secondary|AUC24 for SU-012662 (Sunitinib's Metabolite)|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
2789396|NCT00599924|Secondary|Cmin of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2789397|NCT00599924|Secondary|Tmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
2789398|NCT00599924|Secondary|Cmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng/mL||Standard Deviation|Mean
2789399|NCT00599924|Secondary|Terminal Phase Half-Life (t1/2) of Sunitinib|t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for sunitinib was not calculated due to short observation time.||||||
2789400|NCT00599924|Secondary|Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||ng*hr/mL||Standard Deviation|Mean
2789401|NCT00599924|Secondary|Clearance (CL/F) of Sunitinib|Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.|||L/hr||Standard Deviation|Mean
2789405|NCT00599924|Secondary|Objective Response (OR)|From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)|ITT|||participants|||Number
2789406|NCT00599924|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|up to 20 weeks|Intent to treat (ITT) = all subjects enrolled in the study that received at least one dose of study medication. Subjects who did not complete the follow-up period for dose limiting toxicity assessment because of death from progressive disease or other non-treatment related events were replaced.|||participants|||Number
2789407|NCT00599872|Secondary|Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)|The average combined allergy symptom and medication score during the ragweed season for each subject. This score is computed for each subject by adding their daily relief medication scores (excluding beta-agonist use) and their daily RSS for the entire ragweed season, and then taking the average of the combined scores across days.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
2789408|NCT00599872|Secondary|Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject|Total allergy relief medication score during the ragweed season for each subject. This score is computed for each subject by summing their individual medication scores (excluding beta-agonist use) for the entire ragweed season. High scores were indicative of poor symptom relief from the study medication. The associated relief medication scores assigned to medication are 0-if no medication taken; 3 for each one antihistamine tablet taken; 1 for each 2 antihistamine eye drop administrations, 1 for each 2 antihistamine nasal spray administrations and 1 for each puff of beta-agonist. The maximum medication score was dependent on the cumulative rescue medication use. The lower result the more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
2789409|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);|The average daily RSS during the ragweed season for each of the 3 organ systems (ocular, nasal, ears) were separately analyzed to evaluate these individual components of the RSS. Three separate baseline average daily RSS values were computed for this analysis. The modified ITT population was used for this analysis. The range for scores: 0 to 3 for each of eight symptom or a total of 0 to 24 daily RSS. A lower score was more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
2789410|NCT00599872|Secondary|Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS (the sum of the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS)."|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
2789411|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.~The highest pollen count week was defined as the 7 contiguous days from the series with the largest average pollen count, and in which the weekly average was computed using at least 4 non-missing daily RSS values (either AM or PM could be present to be considered a valid daily RSS value)."|09/01/2008-09/07/2008|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||scores on a scale||Standard Deviation|Least Squares Mean
2789412|NCT00599872|Primary|Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season."|Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)|||Scores on a scale||Standard Deviation|Least Squares Mean
2789441|NCT00599248|Secondary|Number of Participants With Observable Evidence of Cartilage Regeneration|The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production.|Days 0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing|Intention-to-treat|||participants|||Number
2789413|NCT00599755|Post-Hoc|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 30% decrease in SUVmean of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy|||Participants|||Number
2789414|NCT00599755|Secondary|Change in FGD-PET Uptake From Baseline to Week 6|"Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.~The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass."|Baseline and Week 6|Participants with PET scans at baseline and 6 weeks after starting chemotherapy.|||Fold change in SUVmean||90% Confidence Interval|Number
2789415|NCT00599755|Secondary|Change in FDG-PET Uptake From Week 3 to Week 6|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Week 3 and Week 6|Participants with PET scans at 3 weeks and 6 weeks after starting chemotherapy|||Fold change in SUVmean||90% Confidence Interval|Number
2789416|NCT00599755|Secondary|Change in FDG-PET Uptake From Baseline to Week 3|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Baseline and Week 3|Participants with PET scans at baseline and 3 weeks after starting chemotherapy|||Fold Change in SUVmean||90% Confidence Interval|Number
2789417|NCT00599755|Secondary|Repeatability of FDG SUVmean at Baseline|Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy|Participants who underwent two baseline PET scans|||SUVmean||Standard Deviation|Geometric Mean
2789418|NCT00599755|Primary|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy|||Participants|||Number
2789419|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Non-Infl Lesion||Standard Error|Least Squares Mean
2789420|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
2789421|NCT00599521|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to 12 weeks||||% Change in Lesion Count||Standard Deviation|Mean
2789422|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12||Baseline to 12 weeks||||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
2789423|NCT00599521|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12||||Percentage of Participants|||Number
2789424|NCT00599339|Secondary|Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)|The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.|33 months|For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.|||Adverse Events|||Number
2789425|NCT00599339|Secondary|Hoehn & Yahr Stage at Visit 7 (Month 33)|"The Hoehn and Yahr staging of Parkinson's disease in the on stage, if applicable, had to be completed by the physician.~Possible staging:~0 No signs of disease~1 Unilateral disease~2 Bilateral disease without impairment of balance~3 Mild to moderate bilateral disease, some postural instability, physically dependent~4 Severe disability, still able to walk or stand unassisted~5 Wheelchair bound or bedridden unless aided"|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||participants|||Number
2789442|NCT00599248|Secondary|Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site|Number of Patients with Distribution of hChonJb#7 Cells Detected Outside of the Injection Site as determined by PCR analysis for vector DNA.|12 Months||||participants|||Number
2789443|NCT00599248|Secondary|Number of Patients Showing Engraftment at the Defect|Dose Response of the TG-C in Engrafting at the Defect as Compared to Placebo Control|28 Days||||participants|||Number
2789426|NCT00599339|Secondary|Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)|"The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.~The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
2789427|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks What proportion of the waking day is the patient off, on average? Answers range from 0 (None) to 4 (76-100 % of the day)."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
2789428|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question How disabling are the dyskinesias ?  Answers range from 0 (Not disabling) to 4 (Completely disabling)."|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
2789429|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. What Proportion of the waking day are dyskinesias present? Answers range from 0 (None) to 4 (76-100 % of the day)."|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
2789430|NCT00599339|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)|The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."|||units on a scale||Standard Deviation|Mean
2789431|NCT00599326|Secondary|Number of Participants Showing Decrease in Ferritin and Urinary Porphyrin Level|Patients with PCT usually have normal or elevated serum iron and ferritin levels as well as increased iron absorption. Phlebotomy is conducted to analyzes the ferritin levels. Urine collection is performed and samples of the urine are analyzed for porphyrin levels.|6 months||||participants|||Number
2789432|NCT00599326|Primary|Number of Participants Showing Reduction or Elimination of Skin Blistering|The present trial was undertaken to determine if oral deferasirox could be useful in the treatment of PCT. Monthly clinic visits with a physical examination was conducted to assess the skin for blisters.|Within 6 months of treatment.||||participants|||Number
2789433|NCT00599313|Secondary|Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.|Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week's average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week's period.|Baseline and up to 12 months|Patients with pain measurement at baseline.|||percentage of participants||95% Confidence Interval|Number
2789434|NCT00599313|Secondary|Objective Response Rate (ORR)|ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|12 months|Only patients with baseline measurable lesions.|||percentage of participants||95% Confidence Interval|Number
2789435|NCT00599313|Secondary|Change of PSA Doubling Time|Difference of PSA doubling time between baseline and end of the treatment.|Baseline and up to 12 months|Patients who had measurements of prior and post doubling time.|||months||Full Range|Median
2789436|NCT00599313|Secondary|Prostate Specific Antigen (PSA) Response|Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.|Baseline and up to 12 months|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2789437|NCT00599313|Secondary|Overal Survival (OS) Rate at 1-year.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|12 months|ITT population|||Probability of Survival at 1-year||95% Confidence Interval|Number
2789438|NCT00599313|Primary|Median Progression-free Survival (PFS) Time at 1-year.|"PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|12 months|ITT population|||weeks||Full Range|Median
2789439|NCT00599248|Secondary|Number of Patients With Improvements in Pain and Function of the Knee Joint|Assessment of the number of patients with improvement in pain and function of the knee joint|28 Days||||participants|||Number
2789445|NCT00599196|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.|||Score on a scale||Standard Deviation|Mean
2789446|NCT00599196|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.|||Subjects|||Number
2789447|NCT00599196|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.|||Subjects|||Number
2789448|NCT00599131|Secondary|The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia|To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.|3 years.|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
2789449|NCT00599131|Secondary|Overall Survival Time|To determine the overall survival rates compared to the overall survival rates of historical controls.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
2789450|NCT00599131|Secondary|The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.|To evaluate the quality of life (QOL).|24 months|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
2789451|NCT00599131|Secondary|The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.|To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.|Day 23|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.||||||
2789452|NCT00599131|Primary|Percentage of Patients Achieving Histologic Complete Response|The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.||||||
2789453|NCT00599053|Primary|Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of serious of adverse event experienced by subjects treated with azithromycin|from day 1 of study drug through 100 days or discharge from hospital, which ever comes first||||number of events||Full Range|Mean
2789454|NCT00599053|Primary|Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Pharmacokinetic measures (AUC12) of subjects receiving azithromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.|100 days or discharge from hospital|Unable to determine Pharmacokinetics (PK) data due to low enrollment||||||
2789455|NCT00599053|Secondary|Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups|Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.|from baseline to 100 days or discharge from Hospital, which ever comes first||||days||Full Range|Mean
2789456|NCT00599053|Primary|Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of subjects without ureaplasma spp at 100 days after study entry or at hospital discharge in subjects receiving therapy|100 days or discharge from hospital|Unable to determine efficacy due to low enrollment||||||
2789457|NCT00599027|Primary|The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.|To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.|Baseline and 28 days of treatment||||units on a scale||Standard Deviation|Mean
2789458|NCT00599014|Secondary|Hospitalization||30 days||||participants|||Number
2789459|NCT00599014|Primary|Death, Heart Transplant, Left Ventricular Assist Device Implantation||5 years||||participants|||Number
2789460|NCT00598871|Secondary|Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)|Number of diabetic patients who had undergone epithelial debridement during vitrectomy resulted in complete corneal wound closure of the affected eye at the end of treatment (Day 14)|14 days|Analysis per protocol, ITT (Intent to treat), using LOCF (Last Observation Carried Over)|||participants|||Number
2790111|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2789461|NCT00598871|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy|Number of participants with Number of Treatment Emergent Adverse Events (TEAEs) in the Target Eye in diabetic patients who had undergone epithelial debridement during vitrectomy and treated with thymosin beta 4|14 days|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||Participants|||Number
2789462|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Non-Infl Lesion count||Standard Error|Least Squares Mean
2789463|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
2789464|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
2789465|NCT00598832|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to Week 12||||% Change in Lesion Count||Standard Deviation|Mean
2789466|NCT00598832|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12||||Percentage of Participants|||Number
2789467|NCT00598819|Primary|Overheating of Skin Underneath Sensor|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to immediately post-removal||||Participants|||Number
2789468|NCT00598819|Secondary|Sensor Attachment Under Stress|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|addition of stress on sensor to removal.||||Participants|||Number
2789469|NCT00598819|Secondary|Sensor Fits Well on Subjects Forehead|"How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as yes or no."|placement of sensor to end of study observation||||Participants|||Number
2789470|NCT00598819|Primary|Overheating of Skin Underneath Sensor.|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to 10 minutes post-removal.||||Participants|||Number
2789471|NCT00598819|Primary|Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.|Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator.|attachment of sensor to 24 hours post-removal|The number of participants was determined by protocol specifications.|||Participants|||Number
2789472|NCT00598806|Secondary|Overall Survival|The number of months from randomization to death from any cause.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2789473|NCT00598806|Secondary|Disease-Free Survival|The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2789474|NCT00598806|Secondary|Disease-Free Interval|The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2789475|NCT00598806|Secondary|Number of Recurrences Per Patient|The number of histologically confirmed recurrences during the course of the study.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||recurrences||Standard Deviation|Mean
2789476|NCT00598806|Secondary|Time to Progression|The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2789477|NCT00598806|Secondary|Progression Rate at 2 Years|The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
2789478|NCT00598806|Secondary|Time to Recurrence|The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2789479|NCT00598806|Primary|Recurrence Rate at 2 Years|The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
2789480|NCT00598702|Primary|Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event|"A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose to 30 days after last dose|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||Subjects|||Number
2789481|NCT00598702|Secondary|Physician's Global Assessment of Study Treatment|Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).|End of study or Early Termination|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||participants|||Number
2789482|NCT00598702|Primary|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication.|First dose to end of treatment period|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||Subjects|||Number
2789483|NCT00598702|Secondary|Subject's (Parent/Guardian) Global Evaluation of Study Treatment|Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).|Day 0 to Day 5, Day 7 or Early Termination from study|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.|||participants|||Number
2789484|NCT00598689|Secondary|Tolerability and Alleviation of Post-operative Pain in LASIK Surgery|A comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.|Week 1 post surgery|Subjects randomized to either group and completed LASIK surgery.|||percentage of subjects|||Number
2789485|NCT00598689|Secondary|Post Operative Pain Level|Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.|Day 1, End of Week 1|Subjects that completed LASIK surgery.|||units on a scale||Standard Deviation|Mean
2789486|NCT00598689|Primary|Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery|Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). Healing of the area of the cornea covering the radius of the sectioned into clock hours 0 - 12 where 0 hours equals no healing and 12 hours equals complete healing.|Day 1, End of Week 1|Subjects that completed LASIK surgery.|||Clock Hours||Standard Deviation|Mean
2789487|NCT00598663|Secondary|Diabetic Ketoacidosis Events|A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.|6 months||||Participants|||Count of Participants
2789488|NCT00598663|Secondary|Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)|"This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).~Scores are transformed on a scale from 0 to 100. higher values represent a better outcome"|6 months|"In total 72 children took part in the clinical trial: 8 young children (6-7 years), 26 children (8-12 years) and 38 teenagers (13-17 years). Arms/Groups are reported on a per intervention basis"|||units on a scale||Standard Deviation|Mean
2789489|NCT00598663|Secondary|Postprandial Glycaemia|Breakfast Postprandial glycaemia|6 months||||mg/dl||Standard Deviation|Mean
2789490|NCT00598663|Secondary|Daily Min Spent in Euglycaemia (3.9−10.0 mmol/l)||6 months||||minutes||Standard Deviation|Mean
2789491|NCT00598663|Secondary|Number of Severe Hypoglycemia Events||6 months||||participants|||Number
2789492|NCT00598663|Secondary|Glycemic Variability|24 h SD of glucose values (mg/dl)|6 months||||mg/dl||Standard Deviation|Mean
2789493|NCT00598663|Primary|HbA1c at 6 Month|The end of period difference in HbA1c after 6 months of treatment|6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2789494|NCT00598650|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes."|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set|||Score on a Scale||Standard Deviation|Mean
2789495|NCT00598650|Primary|Change From Baseline in Mini-mental State Examination (MMSE) Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.|||Score on a Scale||Standard Deviation|Mean
2789496|NCT00598585|Primary|Change in Fatigue Impact Scale at 6 Weeks|change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated|6 weeks||||units on a scale||Standard Deviation|Mean
2789497|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.|Study period lookback at Day 7|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Units on a scale||Standard Deviation|Mean
2789498|NCT00598559|Primary|Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)|"Serious TEAE is any untoward medical occurrences at any dose of study medication that:~results in death~is life threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose (T0) to within 30 days of the last dose of study medication.|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Participants|||Number
2789499|NCT00598559|Primary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Participants|||Number
2789500|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)|End of Day 5 (prior to discharge)|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.|||Units on a scale||Standard Deviation|Mean
2789501|NCT00598507|Secondary|Occurrence of Attributable Serious Adverse Events (SAEs)|Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.|Up to 5 years|All participants|||participants|||Number
2789502|NCT00598507|Secondary|Median Overall Survival (OS)|Median OS: the time (expressed in months or years) when half the patients are expected to be alive.|Up to 5 years|All participants|||weeks||95% Confidence Interval|Median
2789503|NCT00598507|Secondary|Median Progression Free Survival (PFS)|PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants|||weeks||95% Confidence Interval|Median
2789504|NCT00598507|Primary|Response Rate (RR)|Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants|||participants|||Number
2789505|NCT00598442|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789506|NCT00598442|Secondary|Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789507|NCT00598442|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
2789508|NCT00598273|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.|A hemoglobin response is defined as hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789509|NCT00598273|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789510|NCT00598273|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
2789511|NCT00598078|Primary|Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor|The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left & right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA & EEE sounds, an action evaluation of left & right hands pouring, bringing liquids to mouth, drawing large & small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).|Hour 1||||Points||90% Confidence Interval|Least Squares Mean
2789512|NCT00597909|Secondary|Pharmacokinetic Characteristics of Ammonul® and Its Metabolites||Every 24 hours during treatment period of 96 hours|||||||
2789513|NCT00597909|Secondary|Effects of Ammonul® on Blood Ammonia Levels, Amino Acids and Carnitine||96 hours of treatment and follow-up|||||||
2789514|NCT00597909|Secondary|Efficacy, as Assessed by Severity of Hepatic Encephalopathy Using the Glasgow Coma Scale||96 hours of treatment and follow-up|||||||
2789515|NCT00597909|Secondary|Efficacy, as Assessed by Percentage of Subjects With a 1 or 2 Grade Improvement, Using the West Haven Criteria||participants will be followed for the duration of hospital stay, an expected average of 96 hours|||||||
2789516|NCT00597909|Secondary|Efficacy, as Assessed by Time Spent in an Improved State by 1 or 2 Grades Using the West Haven Criteria||96 hours of treatment and follow-up|||||||
2789517|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With 1-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up|||||||
2789518|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With a 2-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up|||||||
2789519|NCT00597909|Secondary|Safety, as Assessed by Reported Adverse Events, Clinical Laboratory Measurements, Changes in Vital Signs, and Changes in 12-lead ECG Results||96 hours of treatment and follow-up|||||||
2789520|NCT00597909|Primary|Efficacy, as Assessed by Time to Grade 2 or Less in the West Haven Criteria Sustaining for 4 Hours or Longer||Time to Grade 2 or less sustaining for 4 hours or longer|One participant enrolled but did not receive drug or was randomized.||||||
2789521|NCT00597896|Primary|Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency|The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||words||Standard Deviation|Mean
2789522|NCT00597896|Primary|Change From Baseline to Week 8 in Hopkins Verbal Learning Test|The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||words||Standard Deviation|Mean
2789523|NCT00597896|Primary|Change From Baseline to Week 8 in d2 Test of Attention|"The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the d's with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed."|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
2789524|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part B|"The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe executive functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8."|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||seconds||Standard Deviation|Mean
2789525|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part A|"The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe executive functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8."|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||seconds||Standard Deviation|Mean
2790112|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2789526|NCT00597896|Primary|Change From Baseline to Week 8 in Stroop Color-Word Test|The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with 'Xs' printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||words||Standard Deviation|Mean
2789527|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test|Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
2789528|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)|The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||number of correct numbers recalled||Standard Deviation|Mean
2789529|NCT00597896|Secondary|Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint|"The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 (Insight) which is rated on a 5-point Likert scale. These items yield two subscale scores—one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74."|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
2789530|NCT00597896|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||units on a scale||Standard Deviation|Mean
2789531|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)|The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol|||number of correct numbers recalled||Standard Deviation|Mean
2789532|NCT00597818|Secondary|Size of Ulcers/Erosions||at 20 Months|ITT|||mm||Standard Deviation|Mean
2789533|NCT00597818|Secondary|Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers||at Week 4|ITT|||Participants|||Count of Participants
2789534|NCT00597818|Secondary|Number of Participants With Duodenal and Gastroduodenal Ulcers||at 20 months|ITT|||Participants|||Count of Participants
2789535|NCT00597818|Primary|Number of Participants With Gastric Ulcers||at 20 months|Intention to treat (ITT) population, defined as all participants enrolled in the trial|||Participants|||Count of Participants
2789536|NCT00597766|Secondary|Pain Free Abduction Range of Motion (ROM)|Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.|Baseline, weeks 4, 8, 12 (4 times)|Available-case analysis with missing data handled by maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
2789537|NCT00597766|Secondary|Pain Free External Rotation Range of Motion (ROM)|Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.|Baseline, weeks 4, 8, 12 (4 times)|Available-case analysis with missing data handled by maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
2789538|NCT00597766|Secondary|Fugl-Meyer Motor Assessment, Upper Limb Domain|"Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:~0 = cannot perform~= performs partially~= performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions."|Baseline, weeks 4, 8, 12 (4 times)|Available-case analysis with missing data handled by maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
2789571|NCT00597493|Primary|6 Month Progression Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months||||percentage of patients||95% Confidence Interval|Number
2789539|NCT00597766|Primary|BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire|Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.|Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)|We used available-cases. Missing values handled with maximum likelihood methods.|||units on a scale||95% Confidence Interval|Least Squares Mean
2789540|NCT00597753|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789541|NCT00597753|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789542|NCT00597753|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline and Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
2789543|NCT00597727|Secondary|Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing|Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.|36-60 months|Although the 12 month OFC was discontinued beginning in 7/2010, all subjects reaching the end of study (36-60 months of treatment) underwent an OFC resulting in more patients performing the end of study OFC than the 12 month OFC.|||percentage of participants|||Number
2789544|NCT00597727|Primary|Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing|Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.|12 months|Interim analysis in 7/2010 showed statistically significant difference in peanut tolerated during oral food challenge (OFC) by active treatment vs placebo (1710mg vs 85mg). Further OFCs for those on placebo was considered more risk than benefit thus were discontinued resulting in subsequent patients being unblinded after 12 months without an OFC|||percentage of participants|||Number
2789545|NCT00597714|Secondary|Graft Failure|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3-5 weeks after transplant to assess donor-cell engraftment. Primary Graft Failure was defined as a neutrophil count below 500/μL or the absence of donor-derived hematopoiesis (<5%donor cells) before relapse, death, or re-transplantation. Secondary Graft Failure was defined as the achievement of primary engraftment and a subsequent decrease in neutrophils to 3 consecutive counts of less than 100/μL or the absence of donor-derived hematopoiesis (<5% donor cells) before relapse, death, or re-transplantation.|180 days|All subjects who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and donor type.|||number of participants|||Number
2789546|NCT00597714|Other Pre-specified|Graft Versus Host Disease|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3-5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0.|180 days|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type.|||percentage of participants||95% Confidence Interval|Number
2789547|NCT00597714|Secondary|Overall Survival|Estimate overall survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. OS was defined as the period of time between the day of transplantation and death. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants surviving 2 years by donor type is reported.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||percentage of participants||95% Confidence Interval|Number
2790113|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2789548|NCT00597714|Secondary|Progression Free Survival|Progression-free survival (PFS) rates after stem cell transplant were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. PFS was defined as the period of time between the day of transplantation and either the day underlying disease progression was documented or death occurred by any cause. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants progression free at 2 years is reported by donor type. Progression = > 25% increase of serum M-protein and/or urine M-protein. Also, an absolute increase in bone marrow plasma cells > 10%, new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||percentage of participants||95% Confidence Interval|Number
2789549|NCT00597714|Secondary|Immune Recovery|Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. Quantification of CD3+, CD4+, and CD8+ T cells was performed by flow cytometry on fresh peripheral blood at approximately 1 month before transplantation and then 1.5, 3, 6, and 12 months after transplantation. The immune recovery rates of the CD3+, CD4+, and CD8+ T cells in the MRD, MUD, and HAPLO groups were compared by performing an analysis of variance at each time point after transplantation. The median T cell counts at 12 months for each type of cell are reported by donor type.|1 year|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||T cells/μL||Standard Deviation|Mean
2789550|NCT00597714|Primary|Disease Free Survival|Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.|2 years|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).|||percentage of participants||95% Confidence Interval|Number
2789551|NCT00597701|Primary|Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups|In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.|From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.||||mg of benzodiazepine per 8 hours||Standard Deviation|Mean
2789552|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.|Peanut specific IgG4 is thought to have a protective effect for a subject when exposed to peanut possibly by interfering with IgE. Peanut-specific IgG4 is measured from serum in the blood by an immunoCAP machine and reported in mg/dL. A higher level of peanut-specific IgG4 could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.|Baseline to end of open label phase treatment (36-60 months)||||mg/dL||Full Range|Median
2789553|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood|Peanut specific IgE on the surface of mast cells and basophils releases histamine when exposed to peanut causing symptoms of allergy. Free-floating peanut-specific IgE is measured from serum in the blood by an immunoCAP machine and reported in kU/L. A lower level of peanut-specific IgE could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.|Baseline to end of open label phase treatment (36-60 months)||||kU/L||Full Range|Median
2789554|NCT00597675|Secondary|The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing|Skin prick testing is performed by scratching the skin with a small amount of peanut and observing for redness and a raised bump called a wheal. The diameter of the wheal is measured with a ruler in mm and recorded as a measure of peanut-specific IgE and mast cell reactivity in an allergic subject. A decrease in wheal size after treatment would represent suppression of the allergic response.|Baseline to end of open label phase treatment (36-60 months)||||mm||Full Range|Median
2789555|NCT00597675|Secondary|The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment.|After 12 months of blinded Peanut OIT treatment, the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 4710 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.|12 months||||mg of peanut protein||Full Range|Median
2789572|NCT00597428|Secondary|Treatment Effectiveness|Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective|Weeks 1-12|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12).|||units on a scale||Standard Deviation|Mean
2789556|NCT00597675|Primary|The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT.|After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE >2 and <15 AND skin prick test is <5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.|36-60 months||||mg of peanut protein||Full Range|Median
2789557|NCT00597584|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789558|NCT00597584|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||percentage of participants|||Number
2789559|NCT00597584|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline to Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication|||g/dL||Standard Deviation|Mean
2789560|NCT00597558|Secondary|Serum CAP-FEIA to Egg|Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline|24-60 months||||ku/L||Full Range|Mean
2789561|NCT00597558|Secondary|Egg Protein Skin Prick Test After Egg OIT|Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.|24-60 months||||mm||Full Range|Mean
2789562|NCT00597558|Primary|Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg|Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is < 7 kU/L or 90% of entry level IgE or SPT <= 5mm with a maximum treatment period of 60 months.|24-60 months||||subjects with no symptoms on DBPCFC|||Number
2789563|NCT00597545|Primary|Number of Participants With Improved Neuropsychometric Changes|Battery of neuropsychometric tests to evaluate a variety of cognitive functions.|Post-operatively at 1 day||||participants|||Number
2789564|NCT00597519|Primary|Overall Response|To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.|1 year||||participants|||Number
2789565|NCT00597506|Primary|Progression Free Survival (PFS)|8 week PFS|interval between start of treatment and 8-week|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.|||proportion of participants||90% Confidence Interval|Number
2789566|NCT00597506|Primary|Overall Response|Overall response is composed of complete responses and partial responses. Complete response (CR): disappearance of all target lesions; Partial response: at least a 30 percent decrease in the sum of the longest diameter of the target lesions taking as reference the baseline sum longest diameter. Response is assessed at each subject's restaging, approximately ever 2 months.|Measured 1 month after the last treated subject came off treatment|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.|||percentage of participants|||Number
2789567|NCT00597493|Secondary|Pharmacokinetics: AUC-24|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. AUC-24 refers to area under the plasma concentration-time curve from 0 to 24 hours. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAEDs) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.|||ug*H/L||Geometric Coefficient of Variation|Geometric Mean
2789568|NCT00597493|Secondary|Pharmacokinetics: T-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. T-max refers to time to maximum concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.|||hours||Full Range|Median
2789569|NCT00597493|Secondary|Pharmacokinetics: C-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. C-max refers to maximum plasma concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.|||ug/L||Geometric Coefficient of Variation|Geometric Mean
2789570|NCT00597493|Secondary|Safety and Toxicity of Combination|Number of participants experiencing a toxicity of at least grade 3 that was deemed possibly, probably, or definitely related to the treatment.|16 months||||participants|||Number
2789621|NCT00596934|Secondary|Fasting Glucose Value at 12 Months|Fasting glucose value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||mg/dL||Standard Deviation|Mean
2789573|NCT00597428|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular|Weeks 1-12||||units on a scale||Standard Deviation|Mean
2789574|NCT00597428|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks||||participants|||Number
2789575|NCT00597428|Secondary|First Post-dose SBM|The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.|24 and 48 hours post-dose||||participants|||Number
2789576|NCT00597428|Secondary|Change From Baseline in Mean Weekly SBM Frequency|For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.|Baseline, Week 12, and Weeks 1-12||||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
2789577|NCT00597428|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8||Baseline and Week 8||||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
2789578|NCT00597402|Secondary|Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced|55 months||||participants|||Number
2789579|NCT00597402|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|55 months||||participants|||Number
2789580|NCT00597402|Secondary|12-month Progression-free Survival (PFS)|Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|12 months||||percentage of participants||95% Confidence Interval|Number
2789581|NCT00597402|Primary|16-month Overall Survival (OS)|Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.|16 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2789582|NCT00597376|Secondary|Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only|Outcome measures were 6-month levels of highly sensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), malondialdehyde, and potential anti-oxidant (PAO)in blood samples as a percent of baseline value.|6 months|All participants in Intent-to-Treat were included with last observation carried forward.|||percent of baseline level||95% Confidence Interval|Mean
2789583|NCT00597376|Secondary|Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only|Mean study product compliance was measured as the actual number of study product tablets taken as a percent of the maximum study product tablets that could have been taken during the intervention period.|6 months|All participants in Intent-to-Treat cohort were included.|||percent of study drug taken||Standard Error|Mean
2789584|NCT00597376|Primary|Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only|Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.|6 months|The Intent-to-Treat (ITT) cohort included randomized subjects taking at least one study treatment dose. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess 6 month levels in the primary biomarkers. 2-sided, t-test p-value for group differences was only significant (<0.05) for 6-month homocysteine level.|||percent of baseline level||95% Confidence Interval|Mean
2789585|NCT00597272|Primary|Toxicity|Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|2 years||||participants|||Number
2789586|NCT00597207|Primary|Hospital Discharge|Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.|From time of first contact until hospital discharge, up to 90 days.||||participants|||Number
2789587|NCT00597116|Secondary|Overall Survival (OS)||Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.|||Months||95% Confidence Interval|Median
2789588|NCT00597116|Secondary|Progression-free Survival (PFS)|Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.|Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.|||Months||95% Confidence Interval|Median
2789589|NCT00597116|Secondary|Number of Participants With Objective Response.|Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.|||Participants|||Number
2789590|NCT00597116|Primary|Number of Participants With Disease Control.|Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.|||Participants|||Number
2789591|NCT00597038|Secondary|Number of Participants With 12 Month Overall Survival (OS)|Phase II - To determine Overall Survival of patients treated with the combination of dasatinib and DTIC at 12 months.|12 Months|All participants|||participants|||Number
2789592|NCT00597038|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Phase II - PFS Rate in patients receiving dasatinib 70 mg orally (PO) twice a day (BID). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved. Stable disease was defined as maintenance of the sum of lesions diameters between a 30% reduction and a 20% increase of overall tumour size over 12 weeks or longer.|6 Months|Patients receiving dasatinib at 70 mg PO BID|||participants|||Number
2789593|NCT00597038|Primary|Phase II - Number of Participants With Overall Response (OR)|Phase II - To determine the overall response rate (ORR) of the combination of dasatinib and DTIC by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved.|1 Year 6 Months|Patients receiving dasatinib at 70 mg PO BID|||participants|||Number
2789594|NCT00597038|Primary|Recommended Phase II Dose|To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.|1 Year 3 Months|All participants in Arm A|||mg|||Number
2789595|NCT00597012|Secondary|SF-36 Physical Functional Status Scale - Difference From Baseline|Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity.|6 months||||Score||95% Confidence Interval|Mean
2789596|NCT00597012|Secondary|KOOS Pain - Difference From Baseline|Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization.|Baseline to 6 months||||Score||95% Confidence Interval|Mean
2789597|NCT00597012|Primary|WOMAC Functional Status - Difference From Baseline|Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization.|Baseline and 6 months||||Score||95% Confidence Interval|Mean
2789598|NCT00596960|Secondary|Heavy Drinking Days (Greater or Equal to 4 Drinks)|This was measured as heavy drinking days per 30 day time frame. A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. A heavy drinking day was considered to be 4 or greater drinks during a day.|6-months||||heavy drinking days||Standard Deviation|Mean
2789599|NCT00596960|Primary|Percent Days Abstinent From Alcohol at 6 Months|Alcohol use was measured for 30 days at baseline, 3-months and 6-months using the time-line follow back method. Percent days abstinent was measured by determining: days abstinent/30days X 100=%days abstinent.|6-months||||percentage of days abstinent||Standard Deviation|Mean
2789600|NCT00596960|Primary|The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.|A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.|6-months||||Standard Alcohol drinks||Standard Deviation|Mean
2789601|NCT00596947|Secondary|The Number of Participants With Weight Gain|Height, weight will be used to calculate change in BMI for all participants.|12 months|unable to interpret results due to low number of patients enrolled.||||||
2789622|NCT00596934|Secondary|Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months|AST value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||IU/L||Standard Deviation|Mean
2790114|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2789602|NCT00596947|Secondary|The Number of Participants With Post Transplant Diabetes Mellitus|"Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.~Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants."|pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months|unable to interpret results due to low number of patients enrolled.||||||
2789603|NCT00596947|Secondary|The Number of Participants With Bone Disease|Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.|baseline (within 1 month post-transplant), 3, 6, 12 and 24 months|unable to interpret results due to low number of patients enrolled.||||||
2789604|NCT00596947|Secondary|The Number of Participants With Hyperlipidemia|Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789605|NCT00596947|Secondary|The Number of Participants With Hypertension|The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.|12 months|unable to interpret results due to low number of patients enrolled.||||||
2789606|NCT00596947|Secondary|The Number of Participants With Malignancy|Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789607|NCT00596947|Secondary|The Number of Participants With Infections|Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789608|NCT00596947|Secondary|The Number of Participants With Leukopenia|All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).|12 months|unable to interpret results due to low number of patients enrolled.||||||
2789609|NCT00596947|Secondary|The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.|The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.|12 months|unable to interpret results due to low number of patients enrolled.||||||
2789610|NCT00596947|Primary|Participant Survival|The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.|6 and 12 months|data not interpretable due to low patient enrollment||||||
2789611|NCT00596947|Primary|The Number of Participants With Graft Survival|The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.|6 and 12 months|data not interpretable due to low patient enrollment||||||
2789612|NCT00596947|Secondary|Participant Renal Function as Measured by 24 Hour Urine Collection|Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.|3 and 12 months post-transplant|Unable to interpret data due to low number of patients enrolled.||||||
2789613|NCT00596947|Secondary|Participant Renal Function as Measured by MDRD Formula|The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.|3, 6 and 12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789614|NCT00596947|Secondary|The Length of Stay Associated With Hospital Readmissions|The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789615|NCT00596947|Secondary|The Number of Participants With Hospital Readmissions|The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.|12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789616|NCT00596947|Secondary|Length of Hospital Stay After Transplant|The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.|12 months|unable to interpret results due to low number of patients enrolled.||||||
2789617|NCT00596947|Secondary|The Number of Participants With Treatment Failures|This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)|12 months|Unable to interpret data due to low number of patients enrolled.||||||
2789618|NCT00596947|Primary|The Number of Participants With Acute Rejection Episodes|Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.|6 and 12 months post-transplant|data not interpretable due to low patient enrollment||||||
2789619|NCT00596934|Secondary|Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months|HOMA values in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||mU/L x mg/dL||Standard Deviation|Mean
2789620|NCT00596934|Secondary|Fasting Triglycerides Value at 12 Months|Fasting triglyceride value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.|||mg/dL||Standard Deviation|Mean
2789624|NCT00596934|Secondary|Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months|For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs') fractional fat content throughout the liver in a few breath-hold intervals.|1 year||||liver fat percentage||Standard Deviation|Mean
2789625|NCT00596934|Secondary|Body Weight at 12 Months|Body weight (kg) after one year of treatment on metreleptin for patients that completed 12 months of metreleptin treatment.|1 year|Subjects that completed 12 months of metreleptin treatment.|||kg||Standard Deviation|Mean
2789626|NCT00596934|Primary|Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months|Non-alcoholic steatohepatitis (NASH) score after approximately one year of treatment with metreleptin. Total NASH scores can range from 0 to 14. The higher the NASH score the more severe the liver disease.|1 year|Individuals who completed the year of metreleptin treatment and had follow-up liver biopsies after one year.|||units on a scale||Standard Deviation|Mean
2789627|NCT00596830|Secondary|Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels||Cycles 1 and 4 (predose) and at end of treatment|This study was terminated early due to futility. As such, these data were not analyzed.||||||
2789628|NCT00596830|Secondary|Number of Participants With Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose|All participants who received figitumumab (CP-751,871).|||participants|||Number
2789629|NCT00596830|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmin was not summarized.||||||
2789630|NCT00596830|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmax was not summarized.||||||
2789631|NCT00596830|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state."|Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.||||||
2789632|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.||||||
2789633|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.||||||
2789634|NCT00596830|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||percentage of participants||95% Confidence Interval|Number
2789635|NCT00596830|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).|At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2790115|NCT00593606|Primary|Change in Uric Acid|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||µmol/l||Standard Deviation|Mean
2789636|NCT00596830|Primary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline until death, assessed monthly after end of treatment, up to 30 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2789637|NCT00596817|Secondary|Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 24 of the double-blind period (Counted From Double-blind Baseline)|FAS; OC|||units on a scale||Standard Error|Mean
2789638|NCT00596817|Secondary|Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)||Week 24 of the double-blind period|FAS; OC|||percentage of patients|||Number
2789639|NCT00596817|Secondary|Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)||Week 24 of the double-blind period (Counted From Open-label Baseline)|FAS; OC|||percentage of patients|||Number
2789640|NCT00596817|Secondary|Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC|||units on a scale||Standard Error|Mean
2789641|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC|||units on a scale||Standard Error|Mean
2789642|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Depression Scale - 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC|||units on a scale||Standard Error|Mean
2789643|NCT00596817|Secondary|Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment||Double-blind Baseline and Week 24 of the double-blind period|FAS; observed cases (OC)|||units on a scale||Standard Error|Mean
2789644|NCT00596817|Secondary|Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator||Within 64 weeks of the double-blind period|FAS|||percentage of patients who relapsed|||Number
2789645|NCT00596817|Primary|Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Within first 24 weeks of the double-blind period|FAS|||percentage of patients who relapsed|||Number
2789646|NCT00596752|Secondary|Cardiovascular Morbidity During the Course of the Study (up to 196 Days)|Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study.|During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.|||participants|||Number
2789647|NCT00596752|Secondary|Cardiovascular Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.|||participants|||Number
2789648|NCT00596752|Secondary|All-cause Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.|||participants|||Number
2789649|NCT00596752|Secondary|Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment|The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 577 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789650|NCT00596752|Secondary|Minor Amputations at 24 Weeks After the End of Study Drug Treatment|"Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.~The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below."|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 613 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789651|NCT00596752|Secondary|Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment|Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||mmHg||Standard Deviation|Mean
2789652|NCT00596752|Secondary|Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)|The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study.|During the course of the study (up to 196 days)|Full Analysis Set (FAS) consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789653|NCT00596752|Secondary|Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment|In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 465 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789654|NCT00596752|Secondary|Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment|"Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with No and no visit value is specified, the visit value will be set to 0 for the analysis."|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||millimeters (mm)||Standard Deviation|Mean
2789655|NCT00596752|Secondary|Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 568 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789656|NCT00596752|Primary|Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment|Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789657|NCT00596752|Primary|Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 12 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.|||participants|||Number
2789658|NCT00596687|Primary|Mean Blood Glucose Concentration|blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment|hospital stay days 2-10||||mg/dl||Standard Deviation|Mean
2789659|NCT00596687|Secondary|# Participants With Hypoglycemic Events|number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl)|hospital stay days 2-10||||participants|||Number
2789660|NCT00596635|Primary|Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.|Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.|6 months||||Urine cultures|||Number
2789661|NCT00596635|Secondary|Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.|6 months||||Participants|||Number
2789662|NCT00596635|Secondary|Number of Participants With E.Coli Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.|6 months||||Participants|||Number
2789664|NCT00596622|Primary|17-item Hamilton Depression Rating Scale (HDRS)|17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; >20: severe and very severe depression.|Measured at Baseline and after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
2789665|NCT00596466|Primary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.|Baseline up to Week 28|Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.|||Participants|||Number
2789666|NCT00596466|Primary|Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Week 28|Safety analysis set population: all participants who received at least 1 dose of pregabalin.|||Participants|||Number
2789667|NCT00596466|Primary|Seizure Frequency||Baseline up to Week 28|Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.||||||
2789668|NCT00596453|Primary|PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)|"We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test.~We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups."|1 month post enrollment||||ng/mL||Standard Deviation|Mean
2789669|NCT00596440|Secondary|Show Rate at First Treatment Session||week one|This analysis includes only a subset of participants who had not discontinued the study by week 1.|||participants|||Number
2789670|NCT00596440|Secondary|Smoking Cessation Rate||week nine|The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.|||participants|||Number
2789671|NCT00596440|Primary|Accrual Rate (Eligibility Visit)|Show rate to eligibility visit|week zero||||participants|||Number
2789672|NCT00596427|Secondary|Glucagon AUC|"Changes from baseline of glucagon AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||picograms (pg)/milliter (ml) x min||Standard Error|Mean
2789673|NCT00596427|Secondary|Postprandial Fractional Cholic Acid Synthesis|Changes from baseline in fractional cholic acid synthesis after 12 weeks of colesevelam or placebo treatment were evaluated. Fractional cholic acid synthesis represents the relative amount of cholic acid that is made from newly synthesised cholesterol.|baseline and 12 weeks||||Percent new cholic acid||Standard Error|Mean
2789674|NCT00596427|Secondary|Fasting Fractional Cholesterol Synthesis|Changes from baseline in fasting fractional cholesterol synthesis after 12 weeks of colesevelam or placebo treatment. Fractional Cholesterol synthesis represents the fraction of free cholesterol in plasma that was newly synthesised.|baseline and 12 weeks||||Percent new cholesterol||Standard Error|Mean
2789675|NCT00596427|Secondary|Fasting Fractional De Novo Lipogenesis (DNL)|Changes from baseline in fasting fractional DNL after 12 weeks of colesevelam or placebo treatment were calculated. Fractional DNL represents the fraction of palmitate in very-low density lipoproteins-triglycerides (VLDL-TG) that was newly synthesized.|baseline and 12 weeks||||percent new palmitate||Standard Error|Mean
2789676|NCT00596427|Primary|Rate of Appearance of Exogenous Glucose (Glucose Absorption)|Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported.|baseline and 12 weeks||||µmol per kg FFM per minute (min)||Standard Error|Mean
2789677|NCT00596427|Primary|Fasting Glycogenolysis|Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||µmol per kilograms (kg) FFM per min||Standard Error|Mean
2789678|NCT00596427|Primary|Fasting Gluconeogenesis|Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||micromoles (µmol) per kg FFM per min||Standard Error|Mean
2789679|NCT00596427|Other Pre-specified|Glucose AUC|"Changes from baseline of glucose AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||millimoles (mmol)/l x min||Standard Deviation|Mean
2789680|NCT00596427|Other Pre-specified|Glycosylated Hemoglobin (HbAlc)|Changes from baseline of HbA1c after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||percentage||Standard Deviation|Mean
2789681|NCT00596427|Primary|Fasting Endogenous Glucose Production (EGP)|Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks||||umol per kg Fat-Free Mass (FFM) per min||Standard Error|Mean
2789682|NCT00596427|Secondary|Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC|"Changes from baseline of total GIP-1 AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
2789683|NCT00596427|Secondary|Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)|"Changes from baseline of total GLP-1 AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks||||picomoles (pmol)/Liter (L) x minute (min||Standard Deviation|Mean
2789705|NCT00595959|Post-Hoc|Walking Impairment Questionare (WIQ)|Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).|measured at each follow-up period|65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo|||units on a scale 0-100||Standard Deviation|Mean
2789684|NCT00596362|Primary|The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease|At conclusion of study, up to 5 days||||participants|||Number
2789685|NCT00596271|Primary|GMT for Hepatitis A Virus (HAV) Antibody at Day 28||Day 28||||titers||95% Confidence Interval|Geometric Mean
2789686|NCT00596271|Secondary|Safety|Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)|until 6 month after last vaccination|||||||
2789687|NCT00596271|Secondary|GMT and SCR for PRNT at Day 28 and HAV at Day 56||day 28 and 56|||||||
2789688|NCT00596271|Secondary|Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28||day 28 and 56|||||||
2789689|NCT00596271|Primary|Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies|"anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to Outcome 2 within outcome measure section"|Day 56|Per Protocol Population includes all randomized subjects without major protocol deviations|||titers||95% Confidence Interval|Geometric Mean
2789690|NCT00596167|Primary|Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis|"The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis.~(Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)"|Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).||||ml/min||Full Range|Median
2789691|NCT00596102|Secondary|Adverse Events||6, 12, 24, 36, 48 and 60 months after 1st vaccination|||||||
2789692|NCT00596102|Secondary|Geometric Mean Titers||6, 12, 36, 48 and 60 months|||||||
2789693|NCT00596102|Secondary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)||6, 12, 36, 48 and 60 months after 1st vaccination|||||||
2789694|NCT00596102|Primary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)|first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302|24 months after the first vaccination|subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study|||percentage of subjects||95% Confidence Interval|Number
2789695|NCT00596011|Other Pre-specified|Effect of Polyphenon E on the Fundamental Molecular Pathways|Explore the effects of Polyphenon E on the fundamental molecular pathways contributing to chemopreventive activity of Polyphenon E in the prostate. This exploratory aim is ongoing.|12 months|||||||
2789696|NCT00596011|Other Pre-specified|Change in Scores - Lower Urinary Tract Symptom (LUTS)|Change in score from baseline to 1 year. LUTS represent a common conglomeration of storage, voiding, and post-micturition symptoms with reported debilitating effect on quality of life. Symptom severity related to urinary frequency, nocturia, weak urinary stream, hesitancy, intermittency, incomplete bladder emptying and urinary urgency are assessed. We utilized the American Urological Association Symptom Score for the evaluation LUTS in this patient population. Symptom Frequency Scores: 0 = Not at all, 1 = Less than 1 time in 5, 2 = Less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. Total Symptom Score = Sum of individual scores of the 7 symptoms. (minimum possible score=0; maximum possible score =35; Range of scores and significance: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms.|1 year|Participants with LUTS symptom scores available at baseline and at one year|||units on a scale||Standard Deviation|Mean
2789697|NCT00596011|Secondary|Median Serum Total Prostatic Specific Antigen (tPSA)|Median ng/mL serum tPSA post treatment, per treatment arm.|12 months|All participants|||ng/mL||95% Confidence Interval|Median
2789698|NCT00596011|Secondary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|Number of participants with AEs grade 3 or higher, per treatment arm.|12 months|All participants|||participants|||Number
2789699|NCT00596011|Secondary|Treatment Emergent Adverse Events (AEs)|Safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP. Number of participants with AEs Possibly or Probably related to treatment.|12 months|All participants|||participants|||Number
2789700|NCT00596011|Primary|Rate of Progression From HGPIN to ASAP or PCa|Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.|12 months|Baseline HGPIN participants|||participants|||Number
2789701|NCT00596011|Primary|Rate of Progression to Prostate Cancer (PCa)|Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.|12 months|All participants|||participants|||Number
2789702|NCT00595959|Secondary|Volumetric Plaque Reduction|Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.|measured at time of procedure|Per protocol|||millimeters cubed||Standard Deviation|Mean
2789703|NCT00595959|Secondary|Adverse Events|Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.|Through 12 Months||||events|||Number
2789704|NCT00595959|Secondary|Rutherford Classification|Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst|Through 12 Months|63 at baseline; 62 at 30days and 6 months; 63 at 12 months|||units on a scale of 0-6||Standard Deviation|Mean
2790116|NCT00593606|Primary|Change in Total Protein|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||g/dl||Standard Deviation|Mean
2789707|NCT00595959|Secondary|Assisted Secondary Patency|Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site|Through 12 Month|65 at 30 days; 64 at 6 months; 63 at 12 months|||% pts free from secondary patency|||Number
2789708|NCT00595959|Secondary|Assisted Primary Patency|Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion|Through 12 Months|65 at 30 days; 64 at 6 months; 63 at 12 months|||% pts free from assisted primary patency|||Number
2789709|NCT00595959|Secondary|Clinical Success|Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure|measured post discharge thorugh 12 Months follow-up|65 patients at 30 days; 59 at 6 months; 46 at 12 months|||percent of patients|||Number
2789710|NCT00595959|Secondary|Minimum and Maximum Lumen Diameters|Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).|measured at time of procedure|Analysis per protocol|||millimeters||Standard Deviation|Mean
2789711|NCT00595959|Secondary|Procedural Success|Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%.|measured at time of procedure|Per protocol. All enrolled patients|||percent with </=30% RS|||Number
2789712|NCT00595959|Primary|Major Adverse Events|The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.|From discharge through the 6 month follow-up||||events|||Number
2789713|NCT00595959|Primary|Laser Success|The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.|Measured at time of procedure|Per protocol|||percent reduction||Standard Deviation|Mean
2789714|NCT00595946|Secondary|Participant Reported Outcome of Treatment Effectiveness|Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.|within 12 weeks|Intention to Treat with all required scores|||score on a scale||Standard Deviation|Mean
2789715|NCT00595946|Secondary|Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|"Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline.~Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best;~Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;~Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse"|within 12 weeks|Intention to Treat|||score on a scale||Standard Deviation|Mean
2789716|NCT00595946|Secondary|Number of Participants Classified as Responders|Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.|within 12 weeks|Intention to Treat|||Participants|||Count of Participants
2789717|NCT00595946|Secondary|Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose|The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.|within 48 hours post-dose|Intention to treat|||Participants|||Count of Participants
2789718|NCT00595946|Secondary|Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks|Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12|within 12 weeks|Intention to treat with scores at all 12 weeks|||SBMs/Week||Standard Deviation|Mean
2789719|NCT00595946|Primary|Mean Weekly Spontaneous Bowel Movements at Week 8|Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.|at Week 8|Per protocol population at Week 8 without dose reduction|||SBMs/Week||Standard Deviation|Mean
2789720|NCT00595920|Secondary|Evaluate Changes in Annualized Relapse Rate||Annually|||||||
2789721|NCT00595920|Secondary|Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression||Annually|||||||
2789722|NCT00595920|Primary|Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)|This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.|Annually|This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up.||||||
2789739|NCT00595621|Secondary|The Percent (Percentage) of Gastric Retention of a Solid Meal|The retention of a study meal was measured at baseline, 1,2,3 and 4 hours of the test. The percent of food retained in a stomach at 4 hours was compared when MGP-1 was ON and OFF.|12 Weeks||||percent of food retained|||Number
2789740|NCT00595621|Primary|Percentage of Slow Wave Entrainment|Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF|12 Weeks||||percentage of slow waves entrainment||Standard Deviation|Mean
2789741|NCT00595582|Primary|Neuropsychological Scores in Patients With MCI or Mild AD.||within the next three years|No data were collected as this study was terminated.|||units on a scale||Standard Deviation|Mean
2790117|NCT00593606|Primary|Change in Total Bilirubin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
2789723|NCT00595881|Primary|Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.|The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.|18 mos|Assuming a baseline sensitivity of clinical exam alone similar to that previously published (86%), type 1 error rate 0.05, and intraclass correlation coefficient of 0.5 for lesions within patients, we estimated a sample size of 393 lesions would provide 80% power to detect at least a 9% difference in the sensitivity of CE+EUS compared to CE alone.|||Ratio as a percentage||95% Confidence Interval|Number
2789724|NCT00595868|Secondary|7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million|7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.|6 months||||participants|||Number
2789725|NCT00595868|Primary|Number of Participants With a Quit Attempt|A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.|6 months||||participants|||Number
2789726|NCT00595790|Secondary|Safety|AEs, Local and systemic tolerability, Safety laboratory parameters|Study duration|||||||
2789727|NCT00595790|Secondary|GMT at Day 10, 28, 35 and 56||Day 10, 28, 35 and 56|||||||
2789728|NCT00595790|Secondary|SCR at Day 10, 28 and 35||Day 10, 28 and 35|||||||
2789729|NCT00595790|Primary|SCR (Seroconversion Rate) at Day 56|Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer|day 56|The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation|||percentage of participants||95% Confidence Interval|Number
2789730|NCT00595764|Secondary|Overall Health- Short Form (36) Health Survey|"Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.~The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning."|6 months|All participants who completed 1 or more SF-36 assessments were included in the analysis.|||Scores on a scale||Standard Error|Mean
2789731|NCT00595764|Secondary|Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.|The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.|6 months|All participants who completed one or more ASI assessments were included in the analysis.|||Scores on a scale||Standard Error|Mean
2789732|NCT00595764|Secondary|Cocaine Abstinence|Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.|6 months|All participants provided one or more urine screens thus data was based on all participants.|||weeks of abstinence||Standard Deviation|Mean
2789733|NCT00595764|Secondary|Treatment Completion|The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.|6 months|All participants who entered treatment were evaluated for treatment completion.|||participants|||Number
2789734|NCT00595764|Primary|Illicit Opioid Abstinence|number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.|6 months|Repeated measures analysis of variance was used to evaluate differences between groups in the maximum number of consecutive weeks of opioid abstinence for the first and second 12 weeks of treatment. We coded missing urine specimens as positive for opioids in our analysis, thus all participants provided data.|||Weeks of Abstinence||Standard Deviation|Mean
2789735|NCT00595621|Secondary|Changes in Hospital Admissions|Measured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study.|12 Weeks||||days||Full Range|Mean
2789736|NCT00595621|Secondary|Changes in Hemoglobin A1c (HbA1c) Level|HbA1c was evaluated at the baseline and after completion of all the phases of the study|12 Weeks||||% HbA1c||Full Range|Mean
2789737|NCT00595621|Secondary|Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))|Measure represents percentage change from baseline to end of study. QoL measured using the Short Form Health Survey (SF-36) questionnaire. The SF-36 is a generic measure of QoL. Physical QoL (Physical Component Summary; PCS) and emotional QoL (Mental Component summary; MCS) scale components of the survey used for outcome. Scores range from 0 to 100 with lower scores indicating more disability and higher scores less disability.|12 Weeks||||percentage change in scale score||Standard Deviation|Mean
2789738|NCT00595621|Secondary|Severity of Gastroparetic Symptoms|Measure represents change in symptom severity as measured by a self assessment Symptom Interview Form evaluating severity of vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain, and epigastric burning. Symptoms were rated from 0 - absence of symptom to 4 - extremely severe. The overall score was calculated from the sum of seven symptom sub-scores with a total possible score range of 0 - absence of all symptoms to 28 - all symptoms extremely severe.|12 weeks||||units on a scale||Standard Deviation|Mean
2789742|NCT00595556|Secondary|Change in Gamma-glutamyl Transferase (GGT) Concentration|This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.|12 weeks (from initiation to end of treatment)||||Units/Liter||Standard Deviation|Mean
2789743|NCT00595556|Secondary|Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)|This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.|baseline to the end of 12 weeks in treatment||||units on a scale/visit||Standard Deviation|Mean
2789744|NCT00595556|Secondary|Change in Number of Drinks Per Week by Week|This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment|The analysis was intention to treat and last observation carried forward|||drinks/week||Standard Deviation|Mean
2789745|NCT00595556|Primary|Weekly Rate of Change in Abstinent Days|This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).|baseline to the end of 12 weeks in treatment||||days/week||Standard Error|Mean
2789746|NCT00595556|Primary|Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week|This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment||||Days/week||Standard Deviation|Mean
2789747|NCT00595530|Secondary|Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine|Looking at the reduction of opioid utilization while on IV Ketamine. Three participants were enrolled in the study, therefore a comprehensive analysis could not be done due to the low enrollment.|Baseline then daily while inpatient, up to 72 hours||||Participants|||Count of Participants
2789748|NCT00595530|Primary|Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale|Determine if there is an apparent improvement in pain control with the ketamine infusion based on the investigator's discretion and comparison to past pain scores. Pain was scored on a scale from 0 to 10. Zero equaled no pain and 10 equaled a lot of pain.|Baseline then daily while inpatient, up to 72 hours||||Participants|||Count of Participants
2789749|NCT00595517|Primary|Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period||up to 52 weeks||||Participants|||Number
2789750|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment||up to 24 weeks after treatment||||participants|||Number
2789751|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment||up to 12 weeks after treatment||||participants|||Number
2789752|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment||up to 4 weeks after treatment||||Participants|||Number
2789753|NCT00595504|Primary|Change in Abdominal Fat (DEXA).|A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.|||g||Standard Deviation|Mean
2789754|NCT00595504|Primary|Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).|A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.|||HOMA score||Standard Deviation|Mean
2789755|NCT00595504|Primary|Change in Waist Circumference|A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.|||cm||Standard Deviation|Mean
2789756|NCT00595478|Secondary|Days of Alcohol Use During 36-week Follow-up Period|Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.|Monthly up to 9 months (36 weeks)|The analysis population consisted of only participants with follow-up (alcohol use) data on at least 85% of the days in the 36-week follow-up period.|||percentage of days used||Standard Deviation|Mean
2789757|NCT00595478|Primary|Alcohol Abstinence|Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)|Weekly up to 14 weeks||||Samples||Standard Deviation|Mean
2789758|NCT00595465|Secondary|Safety and Adverse Events||Day 56|||||||
2789759|NCT00595465|Secondary|Seroconversion Rate||Day 56|||||||
2789760|NCT00595465|Primary|Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody||Day 56|Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.|||titers||Standard Deviation|Mean
2789773|NCT00595335|Secondary|Change in Proptosis|Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm.|baseline, 12 months after first infusion||||mm||Standard Deviation|Mean
2789761|NCT00595413|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38|ITT population included all randomized participants who received at least 1 study treatment dose.|||participants|||Number
2789762|NCT00595413|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26|"The EULAR response criteria evaluate change in DAS28 scores represented as good response, moderate response, or no response considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have good or moderate EULAR response if at the time of assessment, their DAS28 score was less than or equal to (<=) 5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2."|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
2789763|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
2789764|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
2789765|NCT00595413|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.|||percentage of participants|||Number
2789766|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects||2 weeks after 1st dose of Salmeterol||||% fall FEV1||Standard Deviation|Mean
2789767|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks from pre-salmeterol baseline||||% fall FEV1||Standard Deviation|Mean
2789768|NCT00595361|Primary|Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks after exercise challenge||||% fall FEV1||Standard Deviation|Mean
2789769|NCT00595335|Secondary|Failure Rate at One Year|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|one year|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 52 weeks.|||percentage of participants|||Number
2789770|NCT00595335|Secondary|Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|baseline, 6 months after first infusion, 12 months after first infusion||||units on a scale||Inter-Quartile Range|Median
2789771|NCT00595335|Secondary|Change in Extraocular Motility|"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)."|baseline, 6 months after first infusion, 12 months after first infusion|Intention to treat analysis|||units on a scale||Inter-Quartile Range|Median
2789772|NCT00595335|Secondary|Change in Lid Fissure|"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm."|baseline, 6 months after first infusion|Intention to treat analysis|||mm||Inter-Quartile Range|Median
2790118|NCT00593606|Primary|Change in Sodium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
2789774|NCT00595335|Secondary|Change in Disease Severity|Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0-6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) ).|baseline, 6 months after first infusion|Intention to treat analysis|||participants|||Number
2789775|NCT00595335|Secondary|Failure Rate|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|6 months after first infusion, 12 months after first infusion|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 24 weeks.|||percentage of participants|||Number
2789776|NCT00595335|Primary|Change in Clinical Activity Score (CAS)|The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease.|baseline, 6 months after the first infusion|Sample size was computed based on the expected drop of 2.9 and 1.5 points in the CAS score in rituximab and placebo groups. A sample size of 15 in each group will have 80% power to detect a difference in mean values of 1.4 assuming that the common standard deviation is 1.27 using a two group t-test with a 0.050 two-sided significance level.|||units on a scale||Standard Deviation|Mean
2789777|NCT00595309|Secondary|Geometric Mean Titer||D28, Month 6 and Month 12 after booster|||||||
2789778|NCT00595309|Secondary|Seroconversion||at D28 and Month 6 after booster|||||||
2789779|NCT00595309|Secondary|Safety and Adverse Events||up to Month 12 after booster|||||||
2789780|NCT00595309|Primary|Seroconversion Rate||at Month 12 after booster|Intent-To-Treat Population which includes all subjects entered into the study who received the booster vaccination|||percent||95% Confidence Interval|Number
2789781|NCT00595270|Secondary|Safety Profile of IC51||study duration|||||||
2789782|NCT00595270|Secondary|GMT 1month After Booster Doses||1 month|||||||
2789783|NCT00595270|Secondary|SCR 1 Month After the Booster Doses||1 month|||||||
2789784|NCT00595270|Secondary|Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination||24 months|||||||
2789785|NCT00595270|Secondary|Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination||- 24 months|||||||
2789786|NCT00595270|Secondary|SPR 24 Months After the Primary Vaccination (Observed)|"Persistence of immunogenicity (SPR) at M24 (observed) defined as :~positive (persistent): Subjects~with a non-missing, positive seroconversion at D56 (Study IC51-304), and~who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and~with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and~with a non-missing, SP positive PRNT50 result at Visit 5 (M24)~negative (non-persistent): Subjects~with missing or negative seroconversion at D56 (Study IC51-304), or~who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or~with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or~with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or~with a non-missing, SP negative PRNT50 result at Visit 5 (M24)"|24 months|||||||
2789787|NCT00595270|Primary|Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination|"Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:~pos. (positive) (persistent): Subjects~with a non-missing, pos. seroconversion at D56 (Study IC51-304) and~without booster at M11 or M23 and~with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and~with non-missing, SP pos. PRNT50 at M24~neg. (negative) (non-persistent): Subjects with~missing or neg. seroconversion at D56 (Study IC51-304) or~booster at M11 or at M23, or~non-missing, SP neg. PRNT50 at M6 or M12 or~missing PRNT50 at both M6 and M12 or~missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24"|- 24 months|ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304|||percentage of participants||95% Confidence Interval|Number
2789788|NCT00595231|Primary|Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed|"The Covi Anxiety Scale is a simple 3 item scale for the assessment of severity of anxiety symptoms. The scale measures 3 dimensions: verbal report, behavior and somatic symptoms of anxiety. Each item scored on a scale of 1 - 5. (1)not at all, (2)somewhat, (3)moderately, (4) considerably, and (5)very much), hence the scale is a 5- to 15 point range. The three items are the patient's verbal report (feeling shaky, jittery, jumpy), observed behavior consistent with anxiety during the interview (e.g. appearing frightened, shaky, restless) and somatic complains (e.g., sweating, trembling, heart pounding).~COVI Rating Scale total score is the sum of items 1 - 3."|8 weeks|ITT Population: Randomized and received at least one dose of the study drugs.|||score on a scale||Standard Deviation|Mean
2789789|NCT00595231|Primary|Change From Baseline Raskin Depression Scale.|It explores the extent to which an individual demonstrates depression on three sub-scales (rated 1-5): verbal self-report, behavior and secondary symptoms of depression. Scores range from 3-15, with higher scores indicating greater severity.|8 weeks|ITT Population: Randomized and received at least one dose of the study drugs.|||score on a scale||Standard Deviation|Mean
2789790|NCT00595231|Primary|Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S)|Severity of illness is the first scale in the CGI. A rating is filled in by the investigator at the start of treatment based on a 0-7 point weighted scale. It goes from not assessed (0), to among the most extremely ill patients (7).|8 weeks|ITT Population: Randomized and received at least one dose of the study drugs.|||score on a scale||Standard Deviation|Mean
2789805|NCT00595075|Other Pre-specified|Post-nap Assessment - Visual Analog Scale|numerical scale of increasing alertness from 0-100 (higher values are better outcome)|71 minutes|All participants that completed both crossover periods|||units on a scale||Standard Deviation|Mean
2789791|NCT00595231|Primary|Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics.|The MADRS (Montgomery and Asberg 1979) is a clinician-rated instrument that measures the presence and severity of depression. This instrument consists of 10 items. Each item is rated on a defined step scale of 0 to 6 with anchors at 2-point intervals. The MADRS total score is the sum of the 10 items and ranges from 0 to 60. A high numeric rating shows a greater degree of symptom severity.|8 Weeks|ITT Population: Randomized and received at least one dose of the study drugs.|||score on a scale||Standard Deviation|Mean
2789792|NCT00595231|Primary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics|The Hospital Anxiety and Depression Scale is a self screening questionnaire for depression and anxiety. It consists of 14 questions, seven for anxiety and seven for depression. The 14 statements are relevant to either generalized anxiety (7 statements) or 'depression' (again 7). Each question has 4 possible responses. Responses are scored on a scale from 3 to 0. The maximum score is therefore 21 for depression and 21 for anxiety. A score of 11 or higher indicates the probable presence of the mood disorder with a score of 8 to 10 being just suggestive of the presence of the respective state. The 2 subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into 4 ranges: normal (0-7), mild (8-10), moderate (11-15) and severe (16-21). Anxiety score = sum of items 1, 3, 5, 7, 9, 11, and 13. Depression score = sum of items 2, 4, 6, 8, 10, 12, and 14.|8 Weeks|ITT Population: Randomized and received at least one dose of the study drugs.|||score on a scale||Standard Deviation|Mean
2789793|NCT00595231|Primary|Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed|The Hamilton Anxiety Scale is a 14-item test measuring the severity of anxiety symptoms. It provides measures of overall anxiety, psychic anxiety (mental agitation and psychological distress), and somatic anxiety (physical complaints related to anxiety). The interviewer then rated the individuals on a 5-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining 7 items address somatic anxiety. The total anxiety score ranges from 0 to 56. The 7 psychic anxiety items elicit a psychic anxiety score that ranges from 0 to 28. The remaining 7 items yield a somatic anxiety score that also ranges from 0 to 28. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity, a score of 25 to 30 indicates a moderate to severe anxiety and lastly a score of 31-56 is very severe. HAM-A total score is the sum of items 1 - 14.|8 Weeks|ITT Population: Randomized and received at least one dose of the study drugs.|||score on a scale||Standard Deviation|Mean
2789794|NCT00595153|Primary|Gene Expression in Airway Secretions and Tissues|"The primary outcome measure for this study is the scaled mean value of three gene expression markers of IL-13 in the airway: PERIOSTIN, calcium-activated chloride channel regulator 1 (CLCA1), and plasminogen activator inhibitor-2 (SERPINB2). First, for each of the three interleukin-13 (IL-13) signature genes, the log (base-2) transformed relative expression value for each subject is measured using real-time polymerase chair reaction (PCR) and normalized with the geometric mean of 5 housekeeping genes. Next, these values are centered (by subtracting the mean for that gene) and scaled (by dividing by the standard deviation for that gene) so that each gene makes an equal, assay-independent contribution to the Th2 phenotype. Then, for each subject, the arithmetic mean of the three centered & scaled genes is calculated, producing the three-gene-mean metric."|Healthy Control: Visit 2 (at 1 week); Steroid Naive Asthmatics: Visit 2 (at 1 week); Steroid Treated Asthmatics: Visit 5 (at 9 weeks)|"Participants who met inclusion/exclusion requirements and completed all study activities were included in the analysis. Specifically, this included:~1. Having a bronchoscopy with complete PCR on RNA from epithelial brush samples."|||Relative gene expression level||Standard Deviation|Mean
2789795|NCT00595127|Primary|Incidence & Quality of Engraftment & Hematopoietic Reconstitution|Number of patients who engrafted|8 years||||participants|||Number
2789796|NCT00595114|Primary|8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma|8-isoprostane levels in sputum|Measured at completion of sample analysis||||pg/ml||Standard Deviation|Mean
2789797|NCT00595088|Secondary|Ablative Effect on a Marker Tumor|Complete disappearance of marker lesion|9 weeks||||percentage of participants||90% Confidence Interval|Number
2789798|NCT00595088|Secondary|Time to Tumor Recurrence|The Time to Tumor Recurrence is defined as the interval between the date of the final tumor resection before the start of study treatments to the date when the cystoscopy was performed in which it was confirmed by histopathology that any suspicious lesions that were observed, were TCC of the bladder with the exception of the continued presence of the marker tumor at Week 9|46 Weeks||||months||Full Range|Median
2789799|NCT00595088|Primary|Complete Tumor Response Defined as the Absence of New Tumors|Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions|9 Weeks|All patients who met the study inclusion and exclusion criteria; received all 6 of the induction course intravesical administrations of the investigational product; and had a follow-up cystoscopy during Weeks 8 to 10 and biopsy or TUR of suspicious lesions|||percentage of participants||90% Confidence Interval|Number
2789800|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Number of Lapses|Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome)|8 hours|All participants completing both crossover periods|||lapses||Standard Deviation|Mean
2789801|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Median Reaction Time|Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome)|8 hours|All participants completing both crossover periods|||seconds||Standard Deviation|Mean
2789802|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Drowsiness Test|EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome|71 minutes|All participants completing both crossover periods|||microvolts^2/Hz||Standard Deviation|Mean
2789803|NCT00595075|Other Pre-specified|Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)|A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score|71 minutes|All participants that completed both crossover periods|||correct answers||Standard Deviation|Mean
2789804|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Sleepiness Scale|numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome)|71 minutes|All participants that completed both crossover periods|||units on a scale||Standard Deviation|Mean
2789809|NCT00594958|Primary|GMT for Anti-JEV Neutralizing Antibody|Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.|day 56|Per Protocol Population (observed values)|||GMT||95% Confidence Interval|Geometric Mean
2789810|NCT00594945|Primary|Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).|Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.|Change from baseline to treatment day||||percentage of baseline||Standard Deviation|Mean
2789811|NCT00594906|Primary|Healing of a Fracture From a Low Energy Fall|Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)|Measured at 16 weeks||||participants|||Number
2789812|NCT00594880|Secondary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|24 weeks|percent of consenting eligible participants (n=8) with VL < 400 at week 24 of treatment|||percentage of eligible participants|||Number
2789813|NCT00594880|Secondary|HIV Viral Load < 48 Copies/ml|% of individuals maintaining VL < 48 copies/ml while on pegylated interferon alpha-2a treatment without ART|12 weeks|% of subjects maintaining VL < 48 copies/ml after 12 weeks of treatment|||percentage of participants|||Number
2789814|NCT00594880|Primary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|12 weeks|excluded 2 withdrawal of consent and 1 lost to follow-up|||percentage of participants|||Number
2789815|NCT00594854|Secondary|Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score|The degree of upper gastrointestinal (UGI) injury as measured by Lanza scores (1991) during treatment with PN 400 and ARTHROTEC® in a high-risk population. The Lanza (1991) score is based on endoscopic obeservations and rating these, with no damage, petecchiae, erosions and ulcers. On the 1991 scale, a Lanza score of 0 represents normal mucosa (no damage), while a score of 4 indicates 6-10 erosions, and a score of 7 indicates an ulcer.|6 months||||participants|||Number
2789816|NCT00594854|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.|6 months||||Participants|||Number
2789817|NCT00594854|Secondary|Number of Participants With Duodenal Ulcers Confirmed by Endoscopy|Number of participants with duodenal ulcers confirmed by endoscopy following administration of PN 400 VIMOVO)or Arthrotec in a high risk population|6 months||||participants||95% Confidence Interval|Number
2789818|NCT00594815|Primary|Progression Free Survival|Overall Progression Free Survival at 2 years|2 Years||||percentage of participants||95% Confidence Interval|Number
2789819|NCT00594815|Primary|Total Number of Participants Who Experienced Acute Treatment Related Adverse Events|The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.|2 years||||Participants|||Count of Participants
2789820|NCT00594685|Secondary|Relationship Between the Presence of the Factor V Leiden Mutation or the Prothrombin 20210 Mutation and the Risk of Thrombosis|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.||||||
2789821|NCT00594685|Post-Hoc|Time to First Asymptomatic or Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|Since two versions of the data collection form were used in this study, and only the revised version contained information on whether the event was asymptomatic or symptomatic, a post-hoc analysis was performed which included all thromboses, whether symptomatic, asymptomatic, or of unknown type. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT||||Days||Standard Error|Mean
2789822|NCT00594685|Secondary|Relationship Between PF4-heparin ELISA Test, Serotonin-release Assay, and D-dimer Test Results and Thromboembolism|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.||||||
2789823|NCT00594685|Secondary|Relationship Between the Platelet Factor 4 (PF4)-Heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) Test, the Serotonin-release Assay, and D-dimer Test Results|Analysis not performed since central laboratory tests were not done.|Measured at Day 1|Analysis not performed since central laboratory tests were not done.||||||
2789824|NCT00594685|Secondary|Length of Hospital Stay (With Deaths Not Censored)|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were not censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.|||Days||Standard Error|Mean
2789825|NCT00594685|Secondary|Length of Hospital Stay|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.|||Days||Standard Error|Mean
2789826|NCT00594685|Secondary|Number of Days That Medications Were Given to Participants at Participating Institutions|Per the protocol, descriptive statistics on the types and durations of therapeutic approaches used will be presented.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT||||Days medication was given||Full Range|Median
2789827|NCT00594685|Secondary|Time to Platelet Count Recovery|The time to platelet recovery was defined as the time from the nadir platelet count observed in the five days after the positive HIT test was sent to observing a platelet count of 100K or greater. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject's nadir platelet count was > 100K, so that subject is not included in the analysis.|||Days||Standard Error|Mean
2789828|NCT00594685|Secondary|Time Until Death From All Causes|The time until death from all causes, in days, was determined using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject was censored at the time that the study was terminated.|||Days||Standard Error|Mean
2790119|NCT00593606|Primary|Change in Glutamic Pyruvic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
2789830|NCT00594685|Secondary|The Number of Participants With Incidental Arterial and Venous Thromboembolism (i.e., a Clot Diagnosed by Radiographic Tests Done for Reasons Other Than to Diagnose or Rule Out a Thromboembolic Event)|There were two versions of the data collection form used in this study, and only the revised form contained information on whether the event was incidental.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was incidental. These subjects were censored in the analysis.|||Participants|||Number
2789831|NCT00594685|Secondary|The Number of Participants With Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|There were two versions of the data collection form used in this study, and only the revised version collected information on whether the event was symptomatic.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was symptomatic or asymptomatic. These two subjects were censored in the analysis.|||Participants|||Number
2789832|NCT00594685|Secondary|The Percentage of Participants With Asymptomatic Thrombosis 4 Weeks After the Diagnosis of Isolated HIT, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis 4 weeks after the diagnosis of isolated HIT, determined by four-limb ultrasound, and 95% exact binomial confidence interval.|Measured at Day 35 (+/- 7days)|Four subjects had missing data for this endpoint (no ultrasound performed on end-of-study date) and are not included in this analysis.|||Percentage of participants||95% Confidence Interval|Mean
2789833|NCT00594685|Primary|The Percentage of Participants With Asymptomatic Thrombosis at the Time Isolated Heparin-Induced Thrombocytopenia (HIT) is Diagnosed, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis at the time isolated HIT is diagnosed as determined by four-limb ultrasound.|Measured at Day 1||||Percentage of participants||95% Confidence Interval|Mean
2789834|NCT00594659|Primary|Point Prevalence Abstinence Post Treatment|Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).|9 months (from the end of treatment to 9 months post-treatment).|Intent to Treat|||pecentage of participants abstinent|||Number
2789835|NCT00594659|Primary|Consecutive Weeks of Marijuana Abstinence|Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.|From the start of treatment through the end of the active treatment period, i.e., 12 weeks.|Intent to Treat|||consecutive weeks of abstinence||Standard Deviation|Mean
2789836|NCT00594646|Primary|Number of HIV-1 Infected Participants|Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected|90 days|Participants evaluable at 3 months (90 days) after treatment initiation|||participants|||Number
2789837|NCT00594646|Primary|Medication Regimen Completion Rates|Pill counts performed at 14 and 28 days|28 days||||participants|||Number
2789838|NCT00594568|Secondary|Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2789839|NCT00594568|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2789840|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug|RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2789841|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2789873|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn't time-consuming Item 4: Patch is a considerable option|After subject wakes up from general anesthesia|Full Analysis Set (Subjects having valid data for all three feasibility assessments)|||Score on scale||Standard Deviation|Mean
2789874|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||12 weeks after last treatment|Safety|||percentage of participants|||Number
2789842|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2789843|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2789844|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug|Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
2789845|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789846|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789847|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||hospitalizations/participant||Standard Error|Least Squares Mean
2789848|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789849|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789850|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789851|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789852|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789853|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789854|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2789855|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2789856|NCT00594568|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2789857|NCT00594568|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
2789858|NCT00594568|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
2789859|NCT00594568|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
2789860|NCT00594568|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2789861|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789862|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789863|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug|ADAS‑Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789864|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks|ADAS‑Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
2789865|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.|Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.|14 days for each treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||mg||Standard Deviation|Mean
2789866|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period|Average total daily dose (TDD) of tapentadol IR during the double blind treatment period|14-day for each DB treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||mg||Standard Deviation|Mean
2789867|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||participants|||Number
2789868|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.|||participants|||Number
2789869|NCT00594516|Primary|The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)|"For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|14 days for each cross-over period|Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2789870|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.|Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson's Disease were well controlled Item 3: I felt safe with the Parkinson patch|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)|||Score on scale||Standard Deviation|Mean
2789871|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)|||Score on scale||Standard Deviation|Mean
2789872|NCT00594464|Secondary|Plasma Concentration of Rotigotine After Use.||24 hours|Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)|||ng/ml||Standard Deviation|Mean
2789903|NCT00594425|Secondary|Percent Reduction in Total Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
2789875|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||12 weeks|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||lesions||95% Confidence Interval|Least Squares Mean
2789876|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||percentage of participants|||Number
2789877|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||6 weeks after last treatment|Safety|||percentage of participants|||Number
2789878|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 weeks after first treatment|Safety|||percentage of participants|||Number
2789879|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||2 weeks after last treatment|Safety|||percentage of participants|||Number
2789880|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 days after first treatment|Safety|||percentage of participants|||Number
2789881|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||12 weeks after last treatment|Safety|||percentage of participants|||Number
2789882|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||6 weeks after last treatment|Safety|||percentage of participants|||Number
2789883|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||2 weeks after last treatment|Safety|||percentage of participants|||Number
2789884|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 weeks after first treatment|Safety|||percentage of participants|||Number
2789885|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 days after treatment|Safety|||percentage of participants|||Number
2789886|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Fourth Treatment||immediately after fourth treatment|Safety|||percentage of participants|||Number
2789887|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Third Treatment||immediately after third treatment|Safety|||percentage of participants|||Number
2789888|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Second Treatment||immediately after second treatment|Safety|||percentage of participants|||Number
2789889|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 7 Days After First Treatment||7 days after first treatment|Safety|||percentage of participants|||Number
2789890|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 2 Days After First Treatment||2 days after first treatment|Safety|||percentage of participants|||Number
2789891|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After First Treatment||immediately after first treatment|Safety|||percentage of participants|||Number
2789892|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment||immediately after fourth treatment|Safety|||percentage of participants|||Number
2789893|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Third Treatment||immediately after third treatment|Safety|||percentage of participants|||Number
2789894|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Second Treatment||immediately after second treatment|Safety|||percentage of participants|||Number
2789895|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||2 days after first treatment|Safety|||percentage of participants|||Number
2789896|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||immediately after first treatment|Safety|||percentage of participants|||Number
2789897|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-fourth treatment treatment|Safety|||cm||Full Range|Median
2789898|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after third treatment|Safety|||cm||Full Range|Median
2789899|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after second treatment|Safety|||cm||Full Range|Mean
2789900|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-first treatment|Safety|||cm||Full Range|Median
2789901|NCT00594425|Secondary|The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||percentage of participants|||Number
2789902|NCT00594425|Secondary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Precentage of participants|||Number
2789906|NCT00594425|Secondary|Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
2789907|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
2789908|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||3 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).|||Percentage change||Full Range|Median
2789909|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.|||minutes per week||Standard Deviation|Mean
2789910|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|3 months||||minutes per week||Standard Deviation|Mean
2789911|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|Baseline||||minutes per week||Standard Deviation|Mean
2789912|NCT00594399|Primary|12 Month Fasting Glucose||12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.|||mg/dl||Standard Deviation|Mean
2789913|NCT00594399|Primary|3 Month Fasting Glucose||3 months||||mg/dl||Standard Deviation|Mean
2789914|NCT00594399|Primary|Fasting Glucose||Baseline||||mg/dl||Standard Deviation|Mean
2789915|NCT00594399|Primary|12 Month Fasting Insulin||12 months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.|||uIU/ml||Standard Deviation|Mean
2789916|NCT00594399|Primary|3 Month Fasting Insulin||3 month||||uIU/ml||Standard Deviation|Mean
2789917|NCT00594399|Primary|Fasting Insulin|Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.|Baseline||||uIU/ml||Standard Deviation|Mean
2789918|NCT00594386|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
2789919|NCT00594386|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
2789920|NCT00594386|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
2789921|NCT00594308|Secondary|Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.|Number of patients who died due to transplant related toxicities|up to 2 years after stem cell transplant|Intent To Treat: All patients that received study drug|||participants|||Number
2789922|NCT00594308|Secondary|Time to Resolution of Cytopenias: Platelet Transfusion Independence|Average number of days per patient for resolution of cytopenias.|From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)|IIT: All patients that received study drug.|||days per patient||Standard Deviation|Mean
2789923|NCT00594308|Secondary|Number of Days for Absolute Neutrophil Count to Recover|Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).|From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)|ITT: All patient that received study drug|||days per patient||Standard Deviation|Mean
2789924|NCT00594308|Secondary|Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).||until 30 days after stem cell transplant|ITT population. All patient that received study drug|||participants|||Number
2789925|NCT00594308|Primary|Number of Patients With Acute Grade II-IV GVHD|Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.|until 30 days after stem cell transplant|All patient that received study drug|||participants|||Number
2789926|NCT00594256|Secondary|Slow Wave Sleep Minutes|Overnight sleep study: Subjects will undergo polysomnography four times during this study, on consecutive nights during the observation week and on consecutive nights at the end. Polysomnography will be performed in a modified seclusion room on the in patient unit. The first of the consecutive nights will be used for adaptation to the study conditions. Sleep was recorded between lights off (10 pm) and lights on (at 6:45 am). We aim for conditions for falling asleep as comfortable as possible under the experimental condition.|1 month|4 pre post|||minutes||Standard Deviation|Mean
2789927|NCT00594256|Secondary|MATRICS Neurocognitive Battery Composite|This is a series of neurocognitive tests developed by the National Institute of Mental Health to evaluate medications targeting cognition in an efficient and reliable manner. It will be modified by the deletion of the social competence domain. The six domains include speed of processing, attention/vigilance, working memory, verbal learning, visual learning and reasoning/problem solving. The primary outcome will be the mean T-score (mean of six domains).|1 month||||Composite T-score||Standard Deviation|Mean
2789928|NCT00594256|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Factor|The PANSS Negative factor is a 7-item rating scale widely used in the assessment of schizophrenia. Range is 7-49 with higher scores worse|1 month|Paired t test of baseline and final values|||mean decrease in negative subscale||Standard Deviation|Mean
2789929|NCT00594256|Primary|Epworth Sleepiness Scale|Designed to measure daytime sleepiness. 8 items rated 0-3, with higher scores associated with a greater daytime sleepiness. overall score rated 0-24, with scores greater than 10 indicating significant daytime sleepiness.|1 month||||global score||Standard Deviation|Mean
2789930|NCT00594256|Primary|Pittsburgh Sleep Quality Index|"This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven component scores, each of which has a range of O-3 points. The seven component scores are then added to yield one global score, with a range of O-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas."|1 month|ITT|||global score||Standard Deviation|Mean
2789931|NCT00594230|Secondary|Safety and Tolerability of LBH589 in Patients With Relapsed/Refractory MDS|NOTE: Study terminated early, no results are available for this endpoint|24 months|||||||
2789932|NCT00594230|Secondary|Median Overall Survival|"The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death~NOTE: Study terminated early, no results are available for this endpoint"|24 months on-study, patients followed every 3 months in follow-up|||||||
2789933|NCT00594230|Secondary|Median Time to Treatment Failure|"Time to treatment failure is defined as measuring the time between cycle 1 day 1 to discontinuation for any reason.~NOTE: Study terminated early, no results are available for this endpoint"|24 months|||||||
2789934|NCT00594230|Secondary|Duration of Response|"Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study|||||||
2789935|NCT00594230|Secondary|Hematologic Improvement, Including Transfusion Independence|"Hematologic measures will include total WBC and platelets~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study|||||||
2789936|NCT00594230|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study, every 3 months in follow-up until progression of disease|||||||
2789937|NCT00594230|Primary|Overall Response Rate (CR, Marrow CR + PR) of LBH in Patients With Relapsed or Refractory MDS.|Overall response rate (ORR) is defined by the modified International Working Group (IWG) Response Criteria for MDS. In the marrow, Complete Response (CR) is <= 5% blasts present with normal maturation of all cell lines. In peripheral blood, CR is defined as hemoglobin >= 11 g/dL, ANC >= 1000/mL, and platelets >= 100,000 with 0% blasts present. Partial Response (PR) is defined the same as CR with blasts decreased by >= 50% and >= 5% blasts in the marrow.|Every 8 weeks up to 24 months on-study.|All evaluable patients assessed for response prior to early study termination - one patient in each arm was not evaluable due to coming off-study prior to assessment|||participants|||Number
2789938|NCT00594204|Primary|Number of Participants With 4-week Continuous Abstinence|The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits|Weeks 9 through 12|Intent-to-treat (ITT)|||participants|||Number
2789939|NCT00594204|Secondary|Number of Participants With Seven-day Point Prevalence of Abstinence|Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day|Week 12 and 24|ITT|||participants|||Number
2790120|NCT00593606|Primary|Change in Serum Glutamic Oxaloacetic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
2789940|NCT00594204|Secondary|Number of Participants With Continuous Abstinence|The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm|Weeks 9 through 24|ITT|||participants|||Number
2789941|NCT00594178|Secondary|Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan|Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.|baseline and 3 months Post-exercise||||grams/cm^2||Standard Deviation|Mean
2789942|NCT00594178|Primary|Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data|Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle.|baseline and 3 months|analysis per protocol|||grams||Standard Deviation|Mean
2789943|NCT00594165|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
2789944|NCT00594165|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.|||subjects|||Number
2789945|NCT00594165|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.|||Subjects|||Number
2789946|NCT00594100|Secondary|Patency at 30 Days|Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.|Treatment through 30-day visit window|Subjects with successful stent placement and ultrasound evaluation at 30-day follow-up evaluation.|||participants|||Number
2789947|NCT00594100|Secondary|Clinical Success|Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).|24-48 Hours Post-Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis|||participants|||Number
2789948|NCT00594100|Secondary|Stent Success|Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of < 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.|Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis|||participants|||Number
2789949|NCT00594100|Secondary|Flow Reversal System Success|Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.|Procedure||||participants|||Number
2789950|NCT00594100|Secondary|Flow Reversal System Technical Success|Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)|Procedure|All enrolled subjects|||participants|||Number
2789951|NCT00594100|Primary|Composite Major Adverse Event (MAE) Rate|Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)|Treatment through 30-day visit window|All primary endpoint evaluable subjects|||participants|||Number
2789952|NCT00594061|Secondary|Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral|PB-K Test was constructed to be an open-set test of word understanding for children. It is scored as a percentage of words correct. The test was measured using the Iowa/Nucleus 10/10 mm and Nucleus Freedom together, the Iowa/Nucleus 10/10 mm only, and the Nucleus Freedom electrode only conditions. The higher the score, the better the word understanding. The post-operative time point for this score was reported on average at 56 months post-implantation.|56 months||||percentage of words correct||Standard Error|Mean
2789953|NCT00594061|Primary|Pre-school Language Test|Assesses global language skills using toys and pictures. This test assess auditory comprehension and expressive communication and a total language score is calculated. The reported score was assessed at 48 months post-implantation. The total language standard score ranges from 50-150. A higher total score indicates better performance. A raw score for total language is calculated and converted into a standard score.|48 months||||units on a scale||Standard Deviation|Mean
2789954|NCT00594035|Primary|Watertight Dural Closure|Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.|Intra-Operative||||Participants|||Number
2789955|NCT00594022|Secondary|Scored Sleep Onset Latency (SOL on PSG)|Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG.|Treatment Night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
2789956|NCT00594022|Secondary|Total Sleep Time (TST) in the First Hour After Lights Out|Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out.|Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
2789957|NCT00594022|Secondary|Total Sleep Time (TST) in the First 2 Hours After Lights Out|Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out.|Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.|||minutes||Standard Deviation|Mean
2789958|NCT00594022|Secondary|Subjective Sleep Onset Latency (SOL)|Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes.|Treatment night|"Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.~Not all participants answered this question the following morning, participants analyzed is less"|||minutes||Standard Deviation|Mean
2789959|NCT00594022|Primary|Latency to Persistent Sleep (LPS)|Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up.|Treatment Night|Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.|||minutes||Standard Deviation|Mean
2789960|NCT00594009|Primary|The Amount of CO2 Transferred Through the Oxygenator at Various Levels of Blood and Gas Flow|The amount of CO2 removed in cc/min will be recorded. The level of blood flow (ml/min) and gas flow (l/min) at each measurement of CO2 removal will also be recorded|0 to 96 hours||||cc/min|||Number
2789961|NCT00593957|Secondary|Mean SSI Score for Total Subjects at Baseline and 6 Months|Analysis of Difference in Mean Screen for Social Interaction (SSI) Score between 0-6 months for total sample (n=19).|0-6 months|19 subjects (total sample) for whom complete data was available|||scores on a scale||Standard Deviation|Mean
2789962|NCT00593957|Secondary|Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm.|"The Screen for Social Interaction (SSI) is a 54-item parent/caregiver-report screening instrument that emphasizes reciprocal social interaction including joint attention skills. The items are positive (prosocial) and are scored on a four-point frequency scale (child displays the behavior almost never = 0 to almost all the time = 3). Thus lower scores reflect a slower or delayed development, and higher scores reflect more normative development. SSI total scores range from 0-162. There are no subscales. Difference in Screen for Social Interaction (SSI) mean scores between baseline and 6 months post-treatment for each treatment arm are reported."|Initial and 6 month followup|Those who provided complete information only were included. Others did not provide adequate or complete information for analysis.|||scores on a scale||Standard Deviation|Mean
2789963|NCT00593957|Secondary|Improvement in Receptive Language as Measured by the Mullen Scale.|The Mullen Receptive language scale pre and 6 months post DM, measured as a change in the mean score of language, by age in months.|Change in mean between Initial and 6-month follow-up|25/35 enrolled participants completed the receptive language scale of the Mullen and underwent the analysis.|||age in months||Standard Deviation|Mean
2789964|NCT00593957|Primary|Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm.|Difference in EEG spike count means pre and 6 months post-treatment in each of three treatment groups.|Initial and 6-month post-treatment|33/35 participants who completed the protocol with two epochs of 5 mins of non-Rapid eye movement (REM)sleep during which spikes could be counted pre and post DM intake.|||EEG spike counts per minute||Standard Deviation|Mean
2789965|NCT00593918|Primary|Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression|IL-2 measured from nasal lavage samples by Luminex multiplex assay|1-5 days during acute illness (not after day 5 of illness)||||Percentage of Participants|||Number
2789966|NCT00593918|Primary|Nasal Interferon (IFN)-a2|Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.|1-5 days during acute illness (not after day 5 of illness)|Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|||pg/ml||Standard Deviation|Mean
2789967|NCT00593866|Secondary|The Percentage of Participants Free From Local Progression at 2 Years||2 Years||||percentage of participants||95% Confidence Interval|Number
2789968|NCT00593866|Primary|The Maximum Tolerated Radiation Dose|The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.|13 weeks post radiation||||Gray (Gy)|||Number
2789969|NCT00593840|Post-Hoc|Kaplan Meier Estimate of Progression-free Survival|-Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years||||percentage of participants-Kaplan Meier|||Number
2789970|NCT00593840|Post-Hoc|Kaplan Meier Estimate of Regional Recurrence Free Survival|-Recurrence is defined as the return of cancer after treatment|3 years||||percentage of participants-Kaplan Meier|||Number
2789983|NCT00593827|Secondary|Overall Survival (OS)|"Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.~Survival time (months) = (End date - date of randomization + 1)/30.4375"|From the date of randomization to date of death (maximum participant OS of 26.3 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).|||Months||95% Confidence Interval|Median
2790121|NCT00593606|Primary|Change in Potassium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
2789971|NCT00593840|Secondary|Patterns of Failure Associated With Implementation of Primary Objective|For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center. The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature. The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study. The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease. Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated. As has been the case in our historical controls, the investigators expect most failures to be in the treatment field.|Completion of follow-up (minimum of 5 years from completion of treatment)||2021-04-30|04/2021||||
2789972|NCT00593840|Secondary|Kaplan Meier Estimate of Overall Survival||3 years||||percentage of participants-Kaplan Meier|||Number
2789973|NCT00593840|Secondary|Disease Specific Survival Rate||Completion of follow-up (minimum of 5 years from completion of treatment)||2021-04-30|04/2021||||
2789974|NCT00593840|Secondary|Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms||Completion of follow-up (minimum of 5 years from completion of treatment)||2021-04-30|04/2021||||
2789975|NCT00593840|Secondary|Quality of Life (QOL) as Measured by Xerostomia QOL Data|-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.|Median follow-up was 22 months||||units on a scale||Standard Deviation|Mean
2789976|NCT00593840|Secondary|Quality of Life (QOL) as Measured by Overall Global QOL Scores|-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.|Median follow-up was 22 months|65 out of 73 patients had evaluable QOL data in Arm 1.|||units on a scale||Standard Deviation|Mean
2789977|NCT00593840|Secondary|Kaplan Meier Estimate of Locoregional Recurrence Free Survival|"Recurrence is defined as the return of cancer after treatment~Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame"|3 years||||percentage of participants-Kaplan Meier|||Number
2789978|NCT00593840|Primary|Number of Participants With a Recurrence in the Unirradiated Neck(s)|"Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.~Recurrence is defined as the return of cancer after treatment~Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease."|12 months of follow-up||||participants||95% Confidence Interval|Number
2789979|NCT00593827|Secondary|Incidence of All Grades of Peripheral Neuropathy|All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.|Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|Safety population.|||Participants|||Number
2789980|NCT00593827|Other Pre-specified|Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|"ITT population: Participants randomized on the study (eligible and ineligible). AEs, AEs leading to death and GR 3-4 AEs: Safety population-Participants who received atleast 1 dose of study drug).~AEs leading to death: For 4 participants in Arm 1 and both participants in Arm 2, the reported AE term was disease progression."|||Participants|||Number
2789981|NCT00593827|Secondary|Duration of Response|Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)|ITT population with CR or PR.|||Months||95% Confidence Interval|Median
2789982|NCT00593827|Secondary|Time to Response|"Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.~CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD."|From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)|ITT population with CR or PR.|||Months||Full Range|Median
2790023|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 6-7)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2789984|NCT00593827|Secondary|Best Response as Assessed With RECIST|Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population: All treated participants with CR, PR, SD, PD, or NE response and who had received at least 1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2789985|NCT00593827|Secondary|Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]|"ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.~CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.~Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as ≥10 mm with spiral CT scan."|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population-All treated participants with CR, PR, stable disease (SD), progressive disease (PD), or nonevaluable (NE) response and who had received at least 1 dose of study drug. Please refer outcome measure 4 for explanation of SD, PD, and NE.|||Percentage of Participants||95% Confidence Interval|Number
2789986|NCT00593827|Secondary|Median Progression Free Survival|PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).|||Months||95% Confidence Interval|Median
2789987|NCT00593827|Primary|Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months|PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.|From the date of randomization to 6-months on study|ITT population: Participants who were randomized on the study (eligible and ineligible).|||Percentage of Participants||95% Confidence Interval|Number
2789988|NCT00593814|Secondary|Number of Subjects With Device Efficacy Events||2 years||||Participants|||Count of Participants
2789989|NCT00593814|Primary|Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure||2 years||||participants|||Number
2789990|NCT00593736|Secondary|Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period.|Average Cmax calculated as the average of three highest Cmax observations within the sampling period.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||μg/dL||Standard Error|Least Squares Mean
2789991|NCT00593736|Secondary|The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours|Area under the concentration-time curve is a measure of total drug exposure.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||μg/dL/hour||Standard Error|Least Squares Mean
2789992|NCT00593736|Secondary|The Total Duration of Secretion of Melatonin|The total duration of time from Dim Light Melatonin Secretion Onset to Dim Light Melatonin Secretion Offset.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||minutes||Standard Error|Least Squares Mean
2789993|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Offset|Dim Light Melatonin Secretion Offset is defined as the first time of the morning (on a 24-hour clock) when the melatonin drops to below 3 pg/mL with a negative slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2789994|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Onset|Linear Dim Light Melatonin Secretion Onset is defined as the first time of the evening (on a 24-hour clock) when the melatonin level rises above 3.0 pg/ml with a positive slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2789995|NCT00593736|Secondary|Visual Analogue Scale for Feelings|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value:0 mm.. Best Value:100 mm.. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
2789996|NCT00593736|Secondary|Visual Analogue Scale for Mood|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value: 0 mm. Best Value: 100 mm. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
2790122|NCT00593606|Primary|Change in Inorganic Phosphate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
2789997|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed|After 16 words were read to a subject, a subject waited 1 minute and then was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings' tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||score||Standard Error|Least Squares Mean
2789998|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate|After 16 words were read to a subject, a subject was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings' tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||score||Standard Error|Least Squares Mean
2789999|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test|The number of correct digit-for-number substitutions on a Digit Symbol Substitution Test in the 90-second period was recorded to assess psychomotor and cognitive function. The score was the average of 2 mornings' tests. Worst Value: 0. Best Value: No Limit.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2790000|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your level of alertness this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1."|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790001|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your level of alertness this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1."|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790002|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your ability to concentrate this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1."|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790003|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your ability to concentrate this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1."|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790004|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|"The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, How easy was it for you to wake or get up in the morning when on a school or working night? was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1."|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790005|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|"The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, How easy was it for you to wake or get up in the morning when on a school or working night? was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1."|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790006|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, What time did you try to go to sleep last night? Units are hours and minutes on a 24-hour clock, expressed in decimal time."|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790007|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, What time did you try to go to sleep last night? Units are hours and minutes on a 24-hour clock, expressed in decimal time."|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790008|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe the quality of your sleep last night? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1."|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790009|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe the quality of your sleep last night? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1."|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2790010|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, how many times do you think you woke up?"|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
2790011|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, how many times do you think you woke up?"|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
2790012|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, what is the total time you think you were awake?"|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790013|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, what is the total time you think you were awake?"|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790014|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long (total hours and minutes) do you think you slept last night?"|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790015|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long (total hours and minutes) do you think you slept last night?"|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790016|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)|"Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long do you think it took you to fall asleep last night?"|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790017|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)|"Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long do you think it took you to fall asleep last night?"|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790018|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 13-14)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790019|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 6-7)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790020|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 13-14)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790021|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 6-7)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790022|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 13-14)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790123|NCT00593606|Primary|Change in Glucose|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
2790024|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 13-14)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||wake bouts||Standard Error|Least Squares Mean
2790025|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 6-7)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||wake bouts||Standard Error|Least Squares Mean
2790026|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790027|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790028|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 13-14)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
2790029|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 6-7)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
2790030|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 13-14)|Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790031|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 6-7)|Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790032|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790033|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790034|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790035|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||hours on a 24-hour clock||Standard Error|Least Squares Mean
2790036|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790037|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790038|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
2790039|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||number of awakenings||Standard Error|Least Squares Mean
2790040|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790041|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790042|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
2790043|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
2790044|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
2790045|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||percentage of time asleep||Standard Error|Least Squares Mean
2790046|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790047|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790048|NCT00593736|Secondary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790049|NCT00593736|Primary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 6-7|Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.|||minutes||Standard Error|Least Squares Mean
2790050|NCT00593684|Secondary|Infection Rate|Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.|infection per 1,000 Line Days||||Infection per 1,000 line days|||Number
2790051|NCT00593684|Primary|Serum Silver Concentrate at 28 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|28 Days from enrollment|two subjects died in the treatment group; one subject died in the control group|||ng ml -1||Standard Deviation|Mean
2790052|NCT00593684|Primary|Serum Silver Concentration at 7 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|7 Days from enrollment|One subject in each group died|||ng ml -1||Standard Deviation|Mean
2790076|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.2|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)"|28 days|Full Analysis Set|||participants|||Number
2790053|NCT00593684|Primary|Serum Silver Concentration at 1 Day|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|1 Day (first 24 hours from enrollment)|Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted.|||ng ml -1||Standard Deviation|Mean
2790054|NCT00593645|Secondary|Median Time to Progression|Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.|5 years from time of restaging|Of the four surviving patients, three relapsed. One patient remained in remission on day +120.|||days||Full Range|Median
2790055|NCT00593645|Secondary|Use Conventional STR-PCR Method for Monitoring Engraftment|Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.|Up to 1 year after transplant|This outcome was not analyzed specifically as the conventional STR-PCR method was used for monitoring engraftment.||||||
2790056|NCT00593645|Secondary|Rate of Chronic Graft-versus-host Disease (GVHD)||100 days-1 year after transplant|None of the participants had chronic graft-versus-host disease (GVHD). 3 participants expired prior to day 100.|||percentage of participants|||Number
2790057|NCT00593645|Secondary|Rate of Acute Graft-versus-host Disease (GVHD)|Acute GVHD occurs within 100 days of transplant.|Up to 100 days after transplant||||percentage of participants|||Number
2790058|NCT00593645|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.|5 years from time of restaging|None of the patients analyzed survived without any signs or symptoms of that cancer.|||participants|||Number
2790059|NCT00593645|Secondary|Overall Survival||5 years from time of restaging||||days||Full Range|Median
2790060|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +80-+90|3 participants were not analyzed as they were deceased.|||participants|||Number
2790061|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +40-+60|3 participants were not analyzed because they were expired.|||participants|||Number
2790062|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +30|2 participants were not analyzed because they expired prior to Day +30.|||participants|||Number
2790063|NCT00593645|Secondary|Disease Specific Response Rates|Disease-specific partial response and complete response.|One, three, six and twelve months.|"This outcome was not analyzed due to terminating the study after 7 participants were enrolled.~We felt that the engraftment as measured by percent donor chimerism provided better response details than the limited data that was collected for the disease specific partial and complete response rates."||||||
2790064|NCT00593645|Primary|Six-month Treatment Related Mortality||6 months|"This outcome was not analyzed.~Enrollment to the trial was halted after three of the first seven patients expired. This fulfilled the predefined stopping rule as it was unlikely that we would achieve our primary end point of a 6 month treatment-related mortality of 10%."||||||
2790065|NCT00593606|Secondary|Patient Treatment Preference Scale Question 7|What aspects do you like the least about the patch? Check all that apply.|28 days|Full Analysis Set|||participants|||Number
2790066|NCT00593606|Secondary|Patient Treatment Preference Scale Question 6|What aspects do you like the most about the patch?|28 days|Full Analysis Set|||participants|||Number
2790067|NCT00593606|Secondary|Patient Treatment Preference Scale Question 5|I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease.|28 days|Full Analysis Set|||participants|||Number
2790068|NCT00593606|Secondary|Patient Treatment Preference Scale Question 4|I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease.|28 days|Full Analysis Set|||participants|||Number
2790069|NCT00593606|Secondary|Patient Treatment Preference Scale Question 3|In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch?|28 days|Full Analysis Set|||participants|||Number
2790070|NCT00593606|Secondary|Patient Treatment Preference Scale Question 2|Why did you decide to enter this study?|28 days|Full Analysis Set|||participants|||Number
2790071|NCT00593606|Secondary|Patient Treatment Preference Scale Question 1|Have you used pharmaceutical treatments for your Parkinson's disease before the study?|28 days|Full Analysis Set|||participants|||Number
2790072|NCT00593606|Secondary|Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment|"The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.~Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790073|NCT00593606|Secondary|Patient Global Impression (PGI) Item 3|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)"|28 days|Full Analysis Set|||participants|||Number
2790074|NCT00593606|Secondary|Patient Global Impression (PGI) Item 2|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)"|28 days|Full Analysis Set|||participants|||Number
2790075|NCT00593606|Secondary|Patient Global Impression (PGI) Item 1 Score|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790099|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790077|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.1|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)"|28 days|Full Analysis Set|||participants|||Number
2790078|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 2 Score|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790079|NCT00593606|Secondary|Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set|||score on scale||Standard Deviation|Mean
2790080|NCT00593606|Secondary|Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment|The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790081|NCT00593606|Secondary|Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment|The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790082|NCT00593606|Secondary|Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease.~Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790083|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790084|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790085|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790086|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed|||score on scale||Standard Deviation|Mean
2790087|NCT00593606|Primary|Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set|||participants|||Number
2790088|NCT00593606|Primary|Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set|||participants|||Number
2790089|NCT00593606|Primary|Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set|||participants|||Number
2790090|NCT00593606|Primary|Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set|||participants|||Number
2790091|NCT00593606|Primary|Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment||Baseline, 28 days|Safety Set|||participants|||Number
2790092|NCT00593606|Primary|Completion of Trial From Baseline to End of Treatment||Baseline, 28 days|Safety Set|||participants|||Number
2790093|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790094|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790095|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790096|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790097|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790098|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'||28 days|Safety Set, only patients with non-missing values were analyzed|||participants|||Number
2790127|NCT00593606|Primary|Change in Calcium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mg/dl||Standard Deviation|Mean
2790128|NCT00593606|Primary|Change in Blood Urea Nitrogen|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmol/l||Standard Deviation|Mean
2790129|NCT00593606|Primary|Change in Alkaline Phosphatase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Units/l||Standard Deviation|Mean
2790130|NCT00593606|Primary|Change in Albumin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||g/l||Standard Deviation|Mean
2790131|NCT00593606|Primary|Change in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Giga/l||Standard Deviation|Mean
2790132|NCT00593606|Primary|Change in Red Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Tera/l||Standard Deviation|Mean
2790133|NCT00593606|Primary|Change in Platelet Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Giga/l||Standard Deviation|Mean
2790134|NCT00593606|Primary|Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
2790135|NCT00593606|Primary|Change in Percentage of Monocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
2790136|NCT00593606|Primary|Change in Percentage of Lymphocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
2790137|NCT00593606|Primary|Change in Hemoglobin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||g/l||Standard Deviation|Mean
2790138|NCT00593606|Primary|Change in Hematocrit|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||l/l*100||Standard Deviation|Mean
2790139|NCT00593606|Primary|Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
2790140|NCT00593606|Primary|Change in Percentage of Basophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||Percentage of white blood cell count||Standard Deviation|Mean
2790141|NCT00593606|Primary|Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
2790142|NCT00593606|Primary|Change in QT Interval|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
2790143|NCT00593606|Primary|Change in QRS Duration|"The QRS duration represents the time it takes for ventricular depolarization to occur.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
2790144|NCT00593606|Primary|Change in PR Interval|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||msec||Standard Deviation|Mean
2790145|NCT00593606|Primary|Change in Heart Rate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2790146|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790147|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790148|NCT00593606|Primary|Change in Pulse Rate (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2790149|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790150|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790151|NCT00593606|Primary|Change in Pulse Rate (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2790152|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790153|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 Days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790154|NCT00593606|Primary|Change in Pulse Rate (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2790155|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790156|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||mmHg||Standard Deviation|Mean
2790157|NCT00593606|Primary|Change in Pulse Rate (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed|||beats per minute||Standard Deviation|Mean
2790158|NCT00593554|Secondary|Frequency of Infection|Number of unique patients with bacterial and/or viral infections reported.|Day 0 through 1 year post transplantation|Patients who received a transplant|||Participants|||Count of Participants
2790159|NCT00593554|Secondary|Chronic Graft vs. Host Disease (GvHD)|Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.|Up to 1 year|Patients who received a transplant|||Participants|||Count of Participants
2790160|NCT00593554|Secondary|Acute Graft vs. Host Disease (GvHD)|Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.|Up to 1 year|Patients who received a transplant|||Participants|||Count of Participants
2790161|NCT00593554|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|Patients who received a transplant and who achieved platelet recovery/engraftment of platelets|||days||95% Confidence Interval|Median
2790162|NCT00593554|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|Patients who received a transplant|||days||95% Confidence Interval|Median
2790163|NCT00593554|Secondary|Regimen-related Toxicity|The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.|Up to 1 year|Patients who received a transplant|||Participants|||Count of Participants
2790164|NCT00593554|Primary|Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation|To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.|thru 6 months after transplant|Patients who received a transplant|||percentage of patients||95% Confidence Interval|Number
2790165|NCT00593450|Secondary|Change in Diastolic Blood Pressure From Baseline||Baseline and 1 Year||||mm Hg||Standard Deviation|Mean
2790166|NCT00593450|Secondary|Change in Systolic Blood Pressure From Baseline||Baseline and 1 Year||||mm Hg||Standard Deviation|Mean
2790167|NCT00593450|Secondary|Area of Lesion Change From Baseline||Baseline and 1 Year||||mm^2||Standard Deviation|Mean
2790168|NCT00593450|Secondary|Area of Lesion||at 1 Year||||mm^2||Standard Deviation|Mean
2790169|NCT00593450|Secondary|Dye Leakage on Angiogram||at 1 Year||||Participants|||Number
2790170|NCT00593450|Secondary|Fluid on Optical Coherence Tomography||at 1 Year||||Participants|||Number
2790171|NCT00593450|Secondary|Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea||Baseline and 1 Year||||μm||Standard Deviation|Mean
2790172|NCT00593450|Secondary|Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea||at 1 Year||||μm||Standard Deviation|Mean
2790173|NCT00593450|Secondary|Total Thickness Change From Baseline at Fovea||Baseline and 1 Year||||μm||Standard Deviation|Mean
2790174|NCT00593450|Secondary|Total Thickness at Fovea||at 1 Year||||μm||Standard Deviation|Mean
2790175|NCT00593450|Secondary|Average Cost of Drug/Patient||at 1 Year||||US dollars per patient||Standard Deviation|Mean
2790176|NCT00593450|Secondary|Number of Treatments|Cumulative over the 1 year of trial|1 Year||||Number of Treatments||Standard Error|Mean
2790177|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.~In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity."|at 1 Year||||No. of Letters||Standard Deviation|Mean
2790178|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Frequency)||at 1 Year||||Participants|||Number
2790179|NCT00593450|Primary|Change From Baseline in Visual-acuity Score (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.~In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement."|Baseline and 1 Year|All patients who had VA measured at week 52 were included in the analysis. All analyses were performed on the basis of the intention-to-treat principle. The Data and Safety Monitoring Committee recommended that data for all 23 patients at one center be excluded because of serious protocol noncompliance.|||No. of Letters||Standard Deviation|Mean
2790180|NCT00593450|Secondary|Change From Baseline Visual-acuity Score (Frequency)||Baseline and 1 Year||||Participants|||Number
2790181|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790182|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790183|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790184|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790185|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790186|NCT00593385|Secondary|Secondary Patency|Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790187|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790188|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790189|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790190|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790191|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790192|NCT00593385|Secondary|Primary-Assisted Patency|Continuous flow assisted when the target vessel has restenosed at any time post-procedure.|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790193|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790194|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790195|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790196|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790197|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790198|NCT00593385|Secondary|Primary Patency|Continuous flow without revascularization, bypass or target limb amputation.|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790199|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|36 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790200|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|24 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790201|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|12 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790202|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|9 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790203|NCT00593385|Secondary|Late Clinical Success|Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.|6 Months|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790204|NCT00593385|Secondary|Early Clinical Success|Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.)|1 Month|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790205|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|360 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790206|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|270 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790207|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|180 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790208|NCT00593385|Secondary|Major Adverse Vascular Event (MAVE)|Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.|30 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790209|NCT00593385|Secondary|Major Adverse Event (MAE)|Composite rate of MAVE or any death, or stroke.|30 Days|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790210|NCT00593385|Secondary|Device Success|Successful delivery and deployment of the study stent and intact retrieval of the delivery system.|Post-procedure|ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.|||Participants|||Count of Participants
2790211|NCT00593385|Secondary|Acute Procedural Success|Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.|Post-procedure|Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).|||Participants|||Count of Participants
2790212|NCT00593385|Primary|Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis|The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.|Within 9 Months post-procedure|ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.|||Percentage of subjects|||Number
2790213|NCT00593372|Secondary|Change on Mini-Mental State Examination||End of Study|||||||
2790214|NCT00593372|Primary|Number of Successful Memory Tasks Completed Over Study Period.|"Successful memory tasks are those memory tasks (such as where do I keep my keys) that participants are able to consistently respond to."|8 weeks||||memory tasks|||Number
2790215|NCT00593346|Secondary|Frequency of Grade 3-4 Toxicities|RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.|Up to 1 year from completion of therapy||||participants|||Number
2790216|NCT00593346|Secondary|Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment||5 years after treatment completion||||participants|||Number
2790217|NCT00593346|Secondary|Presence or Absence of Complications|As defined by number of participants who experienced breast infection and symptomatic fat necrosis.|5 years after treatment completion||||participants|||Number
2790218|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||5 years after treatment completion||||percentage of participants|||Number
2790219|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||2 years after treatment completion||||percentage of participants|||Number
2790220|NCT00593346|Primary|Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates||5 years after treatment completion||||percentage of participants|||Number
2790221|NCT00593346|Secondary|Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)|-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)|Pre-treatment and 3 years|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of breast retraction||95% Confidence Interval|Mean
2790222|NCT00593346|Secondary|Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported|"-Patients filled out a form Patient Evaluation of the Treated Breast. On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to:~caused mostly by radiation~caused by both the radiation and surgery, but mostly by the radiation~caused by both the radiation and surgery, but mostly by the surgery~caused mostly by the surgery~can't judge which treatment caused the change~there are no changes"|3 years|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of participants|||Number
2790223|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Physician Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).~The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of participants|||Number
2790224|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Patient Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.~The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.|||percentage of participants|||Number
2790225|NCT00593346|Secondary|Quality of Life Completion|-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.|2 years||||percentage of participants|||Number
2790226|NCT00593346|Primary|Local Control Using Ipsilateral Breast Tumor Recurrence Rates||2 years after treatment completion||||percentage of participants|||Number
2790227|NCT00593333|Primary|Healed Femur Fracture|Time to clinically healed fracture as measured by weeks.|baseline to healed fracture (weeks)||||Weeks||Full Range|Mean
2790228|NCT00593320|Primary|Quality of Life as Measured by the FACT-CNS Questionnaire|"The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns.~Participants can choose 0 (Not At All) up to 4 (Very Much) for each question."|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.||||||
2790229|NCT00593320|Primary|Musculoskeletal Function as Measured by the Oswestry Disability Index|The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.||||||
2790230|NCT00593320|Secondary|Local Control Rate|Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.|6 months after end of treatment|The first patient progressed while on treatment and the second patient was removed from study due to non-compliance.||||||
2790231|NCT00593320|Primary|Pain Control Rate as Measured by the The Brief Pain Inventory|The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.||||||
2790232|NCT00593112|Primary|H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.|||MRS Ratio||Standard Deviation|Mean
2790233|NCT00593112|Primary|H MRS Scan Results - Glutamine (Gln)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.|||MRS Ratios||Standard Deviation|Mean
2790234|NCT00593112|Primary|Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.|||MRS Ratio||Standard Deviation|Mean
2790235|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits||||μg/mL||Standard Deviation|Mean
2790236|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits||||μg/mL||Standard Deviation|Mean
2790237|NCT00592943|Primary|Armodafinil DAT Occupancy in Caudate|Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using [1 1 C]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline).|DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil||||μg/mL||Standard Deviation|Mean
2790238|NCT00592904|Secondary|Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT|Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.|Baseline and Week 48|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2790239|NCT00592904|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)|The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].|Baseline and Week 48|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.|||Participants|||Number
2790240|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48|Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).|Baseline and Week 48|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2790241|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.|SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Baseline and Week 48|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2790242|NCT00592904|Primary|Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.|Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.|Baseline and Week 48|Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.|||Scores on a Scale||Standard Deviation|Mean
2790243|NCT00592852|Secondary|Young Mania Rating Scale (YMRS)|This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60.|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.|||Units on a scale||Standard Deviation|Mean
2790244|NCT00592852|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.|||Units on a scale||Standard Deviation|Mean
2790245|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).|Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (12 weeks)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||nmol/L||Standard Deviation|Median
2790246|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)|Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||ng*ml||Standard Deviation|Mean
2790425|NCT00591344|Secondary|Cognitive Function - Stroop Test|This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790247|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).|Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|From baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||nM BCE||Standard Deviation|Mean
2790248|NCT00592839|Secondary|Mean Change in Stanford Sleepiness Scale|Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||Score on Scale||Standard Error|Least Squares Mean
2790249|NCT00592839|Secondary|Mean Change in Individual Sleep Parameters on a Three-point Scale|Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."|||scores on a scale||Standard Error|Least Squares Mean
2790250|NCT00592839|Primary|Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes|Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the intent-to-treat (ITT) cohort, [all subjects who were exposed to investigational product therapy,provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit]. Not all study subjects completed all data elements in their study diaries."|||Awakenings||Standard Error|Least Squares Mean
2790251|NCT00592774|Secondary|Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF)|Allodynia is defined as a painful reaction to a non-painful stimulus.|Week 15|ITT population (Modified BOCF)|||Participants|||Number
2790252|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)|||Scores on a scale||Standard Deviation|Mean
2790253|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)|||Scores on a scale||Standard Deviation|Mean
2790254|NCT00592774|Secondary|Clinician Global Impression of Change (CGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed CGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used CGIC scores from Early Termination visit.|||Participants|||Number
2790255|NCT00592774|Secondary|Patient Global Impression of Change (PGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.|||Participants|||Number
2790256|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in Average Sleep Interference Scores|The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]), and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)|||Scores on a scale||Standard Deviation|Mean
2790257|NCT00592774|Primary|Change From Baseline in Average Pain Scores by Week|Change from baseline in average pain scores by week based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.|Week 1 through Week 16|ITT Population|||Scores on a scale||Standard Deviation|Mean
2790258|NCT00592774|Primary|Responder Rate: Subjects With at Least 50 Percent Reduction in Pain|A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)|||Percentage of Participants|||Number
2790259|NCT00592774|Primary|Responder Rate: Subjects With at Least 30 Percent Reduction in Pain|A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)|||Percentage of Participants|||Number
2790260|NCT00592774|Primary|Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)|Average pain scores are based on pain intensity (11‑point Likert‑type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|Intent‑to‑Treat (ITT) Population- group of subjects who were randomized, took study drug, and had at least 1 efficacy assessment at Baseline. The modified Baseline Observation Carried Forward (BOCF) method was used.|||Scores on a scale||Standard Deviation|Mean
2790261|NCT00592761|Primary|Change in Duration of Hyoid Maximum Anterior Excursion|Change in the duration of maximum anterior movement of the hyoid bone during swallowing.|Baseline and 6 weeks||||seconds||Standard Deviation|Mean
2790262|NCT00592761|Secondary|Change in Duration of Opening of Upper Esophageal Sphincter|Change in duration of pre- and post-treatment duration of UES opening.|Baseline and 6 weeks||||seconds||Standard Deviation|Mean
2790263|NCT00592761|Secondary|Change in Oral Intake Ability|Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.|Baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
2790264|NCT00592761|Primary|Change in Duration of Superior Hyolaryngeal Movement|Change in duration of superior elevation of hyoid bone.|baseline and six weeks|per protocol|||seconds||Standard Deviation|Mean
2790265|NCT00592683|Secondary|DSM-IV Mania Symptom Checklist|The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.|weekly for first 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.|||units on a scale||Standard Deviation|Mean
2790266|NCT00592683|Primary|Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)|The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.|weekly for 1st 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.|||Units on a scale||Standard Deviation|Mean
2790267|NCT00592631|Primary|Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)|Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.|7 to 10 nights after cpap is started.||||log mg/ml||Standard Error|Mean
2790268|NCT00592553|Other Pre-specified|Study Drug Compliance|Study drug compliance was assessed by participant daily diary and quantification of used and unused study drug. Compliance was assessed in terms of the percentage of drug actually taken relative to the amount that should have been taken during the study.|Baseline to Week 48|As-treated population included all randomized participants who actually received any study treatment.|||percentage of drug||Full Range|Median
2790269|NCT00592553|Other Pre-specified|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. Treatment-emergent adverse event (TEAE) was defined as an adverse event that occurred or worsened in the period extending from first dose of study drug to 6 weeks after the last dose of study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|Baseline up to Week 54|As-treated population included all randomized participants who actually received any study treatment.|||percentage of participants|||Number
2790270|NCT00592553|Secondary|Percent Change From Pre-Treatment Visit (1 Week Prior to Baseline Visit) in Biceps Muscle Dystrophin Expression at Post-Treatment Visit (Week 36), as Determined by Immunofluorescence|Immunofluorescence evidence of a change in dystrophin expression on biceps muscle biopsy was defined as an increase in the staining of the sarcolemmal membrane with an antibody to the C-terminal portion of the dystrophin protein (excluding revertant fibers) between the pre-treatment (1 week prior to Baseline visit) and post-treatment (Week 36) biopsies. The biceps muscle was biopsied from one arm for confirmation of the absence or reduced levels of dystrophin prior to treatment initiation and from the other arm to assess for production of dystrophin post-treatment.|Pre-Treatment (1 week prior to baseline), post-treatment (Week 36)|As-treated population included all randomized participants who actually received any study treatment. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||percent change||Standard Deviation|Mean
2790271|NCT00592553|Secondary|Change From Baseline in Serum Concentration of Creatine Kinase (CK) at Week 48|Blood samples collected for chemistry assays were used to quantify serum CK concentrations. Serum CK was assessed as a potential biomarker for muscle fragility, with a reduction in serum CK considered to be a positive outcome.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||units/liter (U/L)||Standard Deviation|Mean
2790272|NCT00592553|Secondary|Change From Baseline in Heart Rate Before, During, and After Each 6MWT at Week 48, as Assessed by Heart Rate Monitoring With the Polar® RS400|The heart rate was measured with a Polar RS400 heart rate monitor, which consists of a transmitter strap worn around the chest and a wristwatch receiver. The monitor produces a digital text file with 1 value per minute that represents the mean heart rate for that minute. Mean heart rates values were collected prior to, during, and after the 6MWT. The participant rested for 5 minutes in a sitting position prior to the 6MWT, and the mean heart rate for the last minute of this rest period was collected and documented as the resting heart rate. During the 6MWT, the mean heart rate was collected and documented as the active heart rate. After completing the 6MWT and resting for 3 minutes, the mean heart rate for 1 minute was collected and documented as the recovery heart rate.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||beats/minute||Standard Deviation|Mean
2790273|NCT00592553|Secondary|Change From Baseline in Number of Digits Recalled Forwards and Backwards on Digit Span Task at Week 48|Basic attention and working memory was measured using the digit span task. A series of digits (0-9) were presented to the child in an auditory format only. The task had 2 parts; in the forward condition, the child was requested to repeat back the digits in the order they were presented and in the backward condition, he was requested to reverse the order of presentation. A raw score of the total number of correct responses was converted to an age-scaled-score (z-score) by subtracting the corresponding mean and dividing by the corresponding standard deviation of a reference population for that age.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||z-score||Standard Deviation|Mean
2790274|NCT00592553|Secondary|Change From Baseline in Participant/Caregiver-Reported Number of Daily Accidental Falls at Week 48|Number of falls was determined by daily diary records maintained by participants and/or parent/caregivers.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||falls/day||Standard Deviation|Mean
2790275|NCT00592553|Secondary|Parent/Caregiver-Reported Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM consisted of 14 questions about treatment satisfaction with drug in 4 domains: Effectiveness (Questions 1-3 scored as 1 [extremely dissatisfied] to 7 [extremely satisfied]), Side Effects (question 4 scored as 0 [no] or 1 [yes]; question 5 scored as 1 [extremely bothersome] to 5 [not at all bothersome]; questions 6 - 8 scored as 1 [a great deal] to 5 [not at all]), Convenience (questions 9 and 10 scored as 1 [extremely difficult] to 7 [extremely easy]; question 11 scored as 1 [extremely inconvenient] to 5 [extremely convenient]) and Global Satisfaction (question 12 scored as 1 [not at all confident] to 7 [extremely confident]; question 13 scored as 1 [not at all certain] to 5 [extremely certain]; question 14 scored as 1 [extremely dissatisfied] to 5 [extremely satisfied]). The scores of each of the domains were added together and an algorithm was used to create a score of 0 to 100, with higher scores indicating better treatment satisfaction.|Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2790276|NCT00592553|Secondary|Change From Baseline in Parent/Caregiver-Reported HRQL as Measured by the Total Fatigue Scale Score at Week 48|"HRQL was measured via the PedsQL. The fatigue-specific module (including general fatigue, sleep/rest fatigue, and cognitive fatigue scales) comprises an additional 18 questions. The PedsQL was completed by both the participant and/or a parent/caregiver. Fatigue-specific module obtains information relating to items such as: I feel too tired to do things that I like to do; I spend a lot of time in bed; and I have trouble remembering more than one thing at a time; Each of the fatigue-specific module items was scored on a 5-point likert response scale from 0 (never a problem) to 4 (almost always a problem). Scores were transformed on a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating less fatigue. Total score was the sum of all items over the number of items answered on all scales. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48."|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2790277|NCT00592553|Secondary|Change From Baseline in Participant-Reported HRQL as Measured by the Total Fatigue Scale Score at Week 48|"HRQL was measured via the PedsQL. The fatigue-specific module (including general fatigue, sleep/rest fatigue, and cognitive fatigue scales) comprises an additional 18 questions. PedsQL was completed by both the participant and/or a parent/caregiver. Fatigue-specific module obtains information relating to items such as: I feel too tired to do things that I like to do; I spend a lot of time in bed; and I have trouble remembering more than one thing at a time; Each of the fatigue-specific module items was scored on a 5-point likert response scale from 0 (never a problem) to 4 (almost always a problem). Scores were transformed on a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating less fatigue. Total score was the sum of all items over the number of items answered on all scales. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48."|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2790294|NCT00592475|Secondary|Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose|"Baseline serum sodium value is the last measurement prior to dosing.~Change from baseline is calculated as time point minus baseline."|Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title."|||mEq/L||Standard Deviation|Mean
2790278|NCT00592553|Secondary|Change From Baseline in Parent/Caregiver- Reported HRQL as Measured by the PedsQL Physical, Emotional, Social, and School Functioning Domain Scores at Week 48|"HRQL was measured via the PedsQL. The generic core module (including physical, emotional, social and school functioning scales) comprises 23 questions and the fatigue-specific module (including general fatigue, sleep/rest fatigue, and cognitive fatigue scales) comprises an additional 18 questions. The PedsQL was completed by both the participant and/or a parent/caregiver. Examples of items in each of the generic core module scales include: It is hard for me to run; I feel sad or blue; I cannot do things that other kids my age can do; and It is hard to pay attention in class. Each of the generic core module items was scored on a 5-point likert response scale from 0 (never a problem) to 4 (almost always a problem). Scores were transformed on a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating better health-related quality of life. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48."|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2790279|NCT00592553|Secondary|Change From Baseline in Participant- Reported Health-Related Quality of Life (HRQL) as Measured by the Pediatric Quality of Life Inventory (PedsQL) Physical, Emotional, Social, and School Functioning Domain Scores at Week 48|"HRQL was measured via the PedsQL. The generic core module (including physical, emotional, social and school functioning scales) comprises 23 questions and the fatigue-specific module (including general fatigue, sleep/rest fatigue, and cognitive fatigue scales) comprises an additional 18 questions. The PedsQL was completed by both the participant and/or a parent/caregiver. Examples of items in each of the generic core module scales include: It is hard for me to run; I feel sad or blue; I cannot do things that other kids my age can do; and It is hard to pay attention in class. Each of the generic core module items was scored on a 5-point likert response scale from 0 (never a problem) to 4 (almost always a problem). Scores were transformed on a scale from 0 to 100 (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating better health-related quality of life. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48."|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2790280|NCT00592553|Secondary|Change From Baseline in Percentage of Time During the Active Period Spent at Low Activity (Less Than or Equal to [≤] 15 Steps/Minute), Medium Activity (16-30 Steps/Minute), and High Activity (Greater Than [>]30 Steps/Minute) at Week 48|SAM is a pedometer(worn on the ankle) that continuously records the number of steps per time interval. Participants were instructed to continue to wear the SAM for at least 9 consecutive days. SAM was used to record the number of strides/minute following each visit. A stride is the leg motion that begins when the foot with SAM leaves the floor and ends when the same foot touches the floor again. Proportion of time during active periods spent at low activity(≤15 steps/minute), medium activity(16-30 steps/minute), and high activity(>30 steps/minute) were computed for each participant. Mean obtained during Screening and following Week 1 visit were used as baseline data for analysis. For each day, an active period was defined as first time after 3:00 AM that >2 strides/minute were recorded to the last time prior to midnight that >2 strides/minute were recorded. Days were deleted on which such an active period was <50% of the mean active period across all days for that participant's visit.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||percentage of time||Standard Deviation|Mean
2790281|NCT00592553|Secondary|Change From Baseline in Maximum Continuous 10-minute, 20-minute, 30-minute, and 60-minute Total Step Count at Week 48, as Assessed by SAM|SAM is a pedometer (worn on the ankle) that continuously records the number of steps per time interval. Participants were instructed to continue to wear the SAM for at least 9 consecutive days. SAM was used to record the number of strides/minute following each visit. A stride is the leg motion that begins when the foot with SAM leaves the floor and ends when the same foot touches the floor again (that is, a stride generally equals 2 steps). The maximum continuous 10-minute, 20-minute, 30-minute, and 60-minute total step counts were computed for each participant. Mean obtained during Screening (Week -6 to -1) and following Week 1 visit were used as baseline data for analysis. For each day, an active period was defined as the first time after 3:00 AM that >2 strides/minute were recorded to the last time prior to midnight that >2 strides/minute were recorded. Days were deleted on which such an active period was <50% of the mean active period across all days for that participant's visit.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||steps||Standard Deviation|Mean
2790282|NCT00592553|Secondary|Change From Baseline in Mean Total Step Count/Hour During the Active Period at Week 48, as Assessed by SAM|The SAM is a pedometer (worn on the ankle) that continuously records the number of steps per time interval. Participants were instructed to continue to wear the SAM for at least 9 consecutive days. SAM was used to record the number of strides/minute following each visit. A stride is the leg motion that begins when the foot with SAM leaves the floor and ends when the same foot touches the floor again (that is, a stride generally equals 2 steps). Mean total step count/hour during the active periods for the days in a visit was computed for each participant. Mean obtained during Screening (Week -6 to -1) and following Week 1 visit were used as baseline data for analysis. For each day, an active period was defined as the first time after 3:00 AM that >2 strides/minute were recorded to the last time prior to midnight that >2 strides/minute were recorded. Days were deleted on which such an active period was <50% of the mean active period across all days for that participant's visit.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||steps/hour||Standard Deviation|Mean
2790353|NCT00591851|Primary|Cardiac Saftey|LVEF by Muga scan|Baseline-18 months||||percentage of LVEF||Full Range|Median
2790283|NCT00592553|Secondary|Change From Baseline in Mean Total Step Count/Day/Visit During the Active Periods at Week 48, as Assessed by SAM|The SAM is a pedometer (worn on the ankle) that continuously records the number of steps per time interval. Participants were instructed to continue to wear the SAM for at least 9 consecutive days. SAM was used to record the number of strides/minute following each visit. A stride is the leg motion that begins when the foot with SAM leaves the floor and ends when the same foot touches the floor again (that is, a stride generally equals 2 steps). Mean total step count/day/visit during the active periods was computed for each participant. Mean obtained during Screening (Week -6 to -1) and following Week 1 visit were used as baseline data for analysis. For each day, an active period was defined as the first time after 3:00 AM that >2 strides/minute were recorded to the last time prior to midnight that >2 strides/minute were recorded. Days were deleted on which such an active period was <50% of the mean active period across all days for that participant's visit.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||steps/day||Standard Deviation|Mean
2790284|NCT00592553|Secondary|Change From Baseline in Mean Activity Period/Day/Visit at Week 48, as Assessed by Step Activity Monitoring (SAM)|The SAM is a pedometer (worn on the ankle) that continuously records the number of steps per time interval. Participants were instructed to continue to wear the SAM for at least 9 consecutive days. SAM was used to record the number of strides/minute following each visit. A stride is the leg motion that begins when the foot with SAM leaves the floor and ends when the same foot touches the floor again (that is, a stride generally equals 2 steps). Mean activity period/day/visit was computed for each participant. Mean obtained during Screening (Week -6 to -1) and following Week 1 visit were used as baseline data for analysis. For each day, an active period was defined as the first time after 3:00 AM that greater than (>) 2 strides/minute were recorded to the last time prior to midnight that >2 strides/minute were recorded. Days were deleted on which such an active period was less than (<) 50 percent (%) of the mean active period across all days for that participant's visit.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||minutes||Standard Deviation|Mean
2790285|NCT00592553|Secondary|Change From Baseline in Force Exerted During Knee Flexion and Extension, Elbow Flexion and Extension, and Shoulder Abduction at Week 48, as Assessed by Myometry|Upper and lower extremity myometry was performed using a myometer following standardized procedures. Muscle groups evaluated included knee flexors, knee extensors, elbow flexors, elbow extensors, and shoulder abductors. Bilateral assessments were done and 3 measurements were recorded from each muscle group on each side if possible. Mean values for the left and right sides were calculated.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, ‘Number analyzed‘ signifies participants evaluable for specified categories.|||pounds||Standard Deviation|Mean
2790286|NCT00592553|Secondary|Change From Baseline in Time to Descend 4 Stairs at Week 48|If the time taken to perform this test exceeded 30 seconds or if a participant could not perform this test due to disease progression, a value of 30 seconds was used. Change from baseline data has been reported.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, ‘Number analyzed‘ signifies participants evaluable at specified timepoint.|||seconds||Standard Deviation|Mean
2790287|NCT00592553|Secondary|Change From Baseline in Time to Climb 4 Stairs at Week 48|If the time taken to perform this test exceeded 30 seconds or if a participant could not perform this test due to disease progression, a value of 30 seconds was used. Change from baseline data has been reported.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, ‘Number analyzed‘ signifies participants evaluable at specified timepoint.|||seconds||Standard Deviation|Mean
2790288|NCT00592553|Secondary|Change From Baseline in Time to Walk/Run 10 Meters at Week 48|If the time taken to perform this test exceeded 30 seconds or if a participant could not perform this test due to disease progression, a value of 30 seconds was used. Change from baseline data has been reported.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, ‘Number analyzed‘ signifies participants evaluable at specified timepoint.|||seconds||Standard Deviation|Mean
2790289|NCT00592553|Secondary|Change From Baseline in Time to Stand From Supine Position at Week 48|If the time taken to perform this test exceeded 30 seconds or if a participant could not perform this test due to disease progression, a value of 30 seconds was used. Change from baseline data has been reported.|Baseline, Week 48|ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, ‘Number analyzed‘ signifies participants evaluable at specified timepoint.|||seconds||Standard Deviation|Mean
2790290|NCT00592553|Primary|Change From Baseline in 6MWD at Week 48|The 6MWD test was performed in a 30 meters long flat corridor, where the participant was instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Ambulation was assessed via the 6MWD test following standardized procedures by measuring the 6MWD in meters. Participants were not permitted to use assistive devices (walker, long leg braces, or short leg braces) during the 6MWD test.|Baseline, Week 48|Intent-to-treat (ITT) population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, ‘Overall number of participants analyzed‘ signifies participants evaluable for this outcome measure.|||meters||Standard Deviation|Mean
2790291|NCT00592488|Secondary|Serum Lactate|Latest serum lactate between 12 and 36 hours|12-36 hours||||mg/dL||Standard Deviation|Mean
2790292|NCT00592488|Secondary|Vasopressor Dose|Change in vasopressor dose between 6 and 24 hours.|6-24 hours||||mcg/kg/min||Standard Deviation|Mean
2790293|NCT00592488|Primary|Mean Arterial Blood Pressure|Mean Arterial blood pressure measured non-invasively at 18 hours|18 hours|All patients treated. Intention to treat.|||mm Hg||Standard Error|Mean
2790295|NCT00592475|Primary|Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table."|||bpm||Standard Deviation|Mean
2790296|NCT00592475|Primary|Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table."|||mmHg||Standard Deviation|Mean
2790297|NCT00592475|Primary|Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title."|||mmHg||Standard Deviation|Mean
2790298|NCT00592475|Primary|Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline. (Note: 2 patients were not included in the analysis due to protocol deviations.) The number of participants included in the calculation for each timepoint is noted in the category title.|||mL/min||Standard Deviation|Mean
2790299|NCT00592475|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents Full Analysis Set (FAS): All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants per arm is consistent for all categories of the data table."|||mmHg||Standard Deviation|Mean
2790300|NCT00592384|Primary|Hamilton Depression Rating Scale-Maier Subscale|The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.|0 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2790301|NCT00592384|Secondary|Hamilton Rating Scale for Anxiety||Weeks 0, 12|||||||
2790302|NCT00592384|Secondary|Patient Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
2790303|NCT00592384|Secondary|Clinical Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
2790304|NCT00592384|Secondary|Sheehan Disability Scale||Weeks 0, 12|||||||
2790305|NCT00592384|Secondary|Satisfaction With Life||Weeks 0, 12|||||||
2790306|NCT00592384|Secondary|Craig Handicap and Reporting Technique||Weeks 0, 12|||||||
2790307|NCT00592384|Secondary|Side Effects Checklist||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
2790308|NCT00592384|Secondary|SF-12||Weeks 0, 12, 24|||||||
2790309|NCT00592384|Secondary|Structured Clinical Interview for DSM IV Depression Module||Weeks 0, 12, 24|||||||
2790310|NCT00592384|Secondary|Modified Ashworth Spasticity Scale||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
2790311|NCT00592384|Secondary|Modified Brief Pain Inventory||Weeks 0, 1, 3, 6, 8, 10, 12|||||||
2790312|NCT00592384|Secondary|Symptom Checklist-20 Depression Subscale||Weeks 0, 1, 3, 6, 8, 10, 12, 24|||||||
2790313|NCT00592384|Primary|Hamilton Depression Rating Scale-17|The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.|0 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2790314|NCT00592358|Secondary|Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist|A 13-item clinician-rated symptom checklist developed by Massachusetts General Hospital to measure symptoms of mania. Each item is given a rating for frequency (1=less than 4 days, 2=greater than or equal to 4 days, 3=daily) and intensity (1=mild, 2=moderate, 3=severe), which are combined to yield a composite severity score ranging from 0 (least severe) to 3 (most severe). The composite severity scores from all 13 items are summed to yield a total measure score, with a minimum score of 0 (least severe) and a maximum score of 39 (most severe).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|All participants for whom the mania checklist was available at both baseline and endpoint (8-weeks) were included in analyses.|||units on a scale||Standard Deviation|Mean
2790315|NCT00592358|Primary|Change in Symptoms Measured by Young Mania Rating Scale (YMRS)|The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|Participants exposed to study medication for a minimum of three weeks were included in analyses.|||units on a scale||Standard Deviation|Mean
2790394|NCT00591591|Primary|Percentage of Oxygen Saturation in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.|||Percentage of brain oxygen saturation||Standard Deviation|Mean
2790316|NCT00592319|Primary|Number of Case With Papilloma Recurrence During a 12-month Follow up|Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.|12-month follow up|The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.|||case|||Number
2790317|NCT00592319|Secondary|Time Course (Month) With Papilloma Recurrence During 12-month Follow up|The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.|12 months|12-month follow-up|||month||Full Range|Mean
2790318|NCT00592176|Secondary|Number of Patients Having Surgical Removal of Pterygium.|The number of patients having surgical removal of pterygium within 12 months.|12 months|All subjects enrolled were analzyed.|||Participants|||Number
2790319|NCT00592176|Primary|The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.|"Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression~Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression."|Baseline and 3 months|All subjects enrolled were analzyed.|||area in millimeters squared||Standard Deviation|Mean
2790320|NCT00592124|Secondary|Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol||Measured through Week 21||||Participants|||Count of Participants
2790321|NCT00592124|Secondary|Reported Sharing of Product|Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant.|Measured through Week 21|Participants who completed a product sharing assessment at the end of the 6-week product use period.|||Participants|||Count of Participants
2790322|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein gel was used after the encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
2790323|NCT00592124|Secondary|Gel Usage After Sex|These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as gel use|||Sexual Encounters|Sexual Encounters||Count of Units
2790324|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein gel was used before the encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
2790325|NCT00592124|Secondary|Gel Usage Before Sex|These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as gel use|||Sexual Encounters|Sexual Encounters||Count of Units
2790326|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein tablets were used after the encounters. Timing data was not provided for two sexual encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
2790327|NCT00592124|Secondary|Tablet Usage After Sex|These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as tablet use|||Sexual Encounters|Sexual Encounters||Count of Units
2790328|NCT00592124|Secondary|Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.|Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).|Measured through Week 21|Last instances of vaginal sexual intercourse wherein tablets were used before the encounters. Timing data was not provided for four sexual encounters.|||minutes|Sexual Encounters|Inter-Quartile Range|Median
2790329|NCT00592124|Secondary|Tablet Usage Before Sex|These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.|Measured through Week 21|Last instance of vaginal intercourse on the same day as tablet use|||Sexual encounters|Sexual encounters||Count of Units
2790330|NCT00592124|Secondary|Frequency of Male Condom Use||Measured through Week 21||||3-week periods|3-week periods||Count of Units
2790331|NCT00592124|Secondary|Frequency of Sexual Activity|This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.|Measured through Week 21||||3-week periods|3-week periods||Count of Units
2790332|NCT00592124|Secondary|Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses||Measured through Week 21|This outcome is based on evaluable participants.|||Participants|||Count of Participants
2790333|NCT00592124|Secondary|Number of Days Product Missed|This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.|Measured through Week 21|This outcome is based on evaluable participants.|||days|3-week periods|Standard Deviation|Mean
2790334|NCT00592124|Secondary|Frequency of Product Use|This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.|Measured through Week 21||||3-week periods|3-week periods||Count of Units
2790335|NCT00592124|Primary|Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)|PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.|Measured through Week 21|Serum TFV and Tissue TFV measures do not include participants from South Africa clinical sites.|||ng/mL, ng/mg, ng/mL||Inter-Quartile Range|Median
2790336|NCT00592124|Primary|"Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future"||Measured through Week 21||||Participants|||Count of Participants
2790337|NCT00592124|Primary|Self-reported Adherence to Each Regimen|Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.|Measured through Week 21|For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of expected doses if she were fully adherent.|||percentage of expected doses||Standard Deviation|Mean
2790338|NCT00592072|Primary|Telephone Search|This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||symbols/ 90 min||Standard Error|Least Squares Mean
2790339|NCT00592072|Primary|Map Search (1min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790340|NCT00592072|Primary|Map Search (2min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790341|NCT00592072|Primary|Digit Symbol Coding|The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790342|NCT00592072|Primary|Letter/Number Sequencing|The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790343|NCT00592072|Primary|Digit Span Backward|The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790344|NCT00592072|Primary|Verbal Memory Recognition|The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790345|NCT00592072|Primary|Delayed Verbal Memory|The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790346|NCT00592072|Primary|Immediate Verbal Memory|Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.|||units on a scale||Standard Error|Least Squares Mean
2790347|NCT00592007|Secondary|Overall Survival||Patients will be followed until death|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.||||||
2790348|NCT00592007|Primary|Progression-free Survival||14 weeks after start of fulvestrant|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data were not collected for this Outcome Measure. Outcomes were not collected due to withdrawal of the funding. Data not available.||||||
2790349|NCT00591942|Primary|Incidence of Post-operative Pain (Yes/no)|Scores reported are subjects reporting any pain (yes/no)|Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations||||participants|crowns||Number
2790350|NCT00591864|Secondary|Specificity|The number of women with negative imaging test per number of women without cancer.|at least one year following imaging||||participants|||Number
2790351|NCT00591864|Secondary|Sensitivity on the Per Tumor Level|Number of tumors detected per number of tumors diagnosed on surgery or biopsy.|within 1 week of surgery or biopsy||||tumors|Participants||Number
2790352|NCT00591864|Primary|Sensitivity on the Per Patient Level|Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.|within 1 week of surgery or biopsy|In the 84 patients who completed the study 28 were diagnosed with breast cancer.|||participants|||Number
2790354|NCT00591838|Secondary|Phase II Only: Overall Survival Rate|Overall survival is defined as patients alive|2 years|Phase I participants were excluded from this outcome measure. 1 patient in Phase II did not come back for follow-up and was excluded from analysis. The remaining 50 participants were analyzed for the outcome measure but only those who were not lost to follow-up or deceased at 2 years were included in the outcome measure results.|||percentage of participants||95% Confidence Interval|Number
2790355|NCT00591838|Secondary|Phase II Only: Disease-free Survival Rate|Disease-free survival rate is defined as patients without any disease failure (progression), second primary, or death from any cause.|2 years|Phase I participants were excluded from this outcome measure. 1 patient in Phase II did not come back for follow-up and was excluded from analysis. The remaining 50 participants were analyzed for the outcome measure but only those who were not lost to follow-up or deceased at 2 years were included in the outcome measure results.|||percentage of participants||95% Confidence Interval|Number
2790356|NCT00591838|Secondary|Phase II Only: Disseminated Recurrence Rate|Disseminated recurrence is defined as the absence of failure (progression) outside ipsilateral lung and hilar/mediastinal/supraclavicular lymph nodes.|2 years|Phase I participants were not evaluable for this outcome measure. 1 patient in Phase II did not come back for follow-up and was excluded from analysis. The remaining 50 participants were analyzed for the outcome measure but only those who were not lost to follow-up or deceased at 2 years were included in the outcome measure results.|||percentage of participants||95% Confidence Interval|Number
2790357|NCT00591838|Secondary|Phase II Only: Regional Nodal Recurrence Rate|Regional nodal recurrence is defined as absence of isolated failure (progression) within hilar/mediastinal/supraclavicular lymph nodes.|2 years|Phase I participants were not evaluable for this outcome measure. 1 patient in Phase II did not come back for follow-up. The remaining 50 participants were analyzed for the outcome measure but only those who were not lost to follow-up or deceased at 2 years were included in the outcome measure results.|||percentage of participants|||Number
2790358|NCT00591838|Primary|Phase II Portion Only: Local Control Rate|Local control rate is defined as the absence of isolated failure (progression) within the primary tumor and involved lobe|2 years|Phase I participants were not evaluable for this outcome measure. 1 patient in Phase II did not come back for follow-up. The remaining 50 participants were analyzed for the outcome measure but only those who were not lost to follow-up or deceased at 2 years were included in the outcome measure results.|||percentage of participants||95% Confidence Interval|Number
2790359|NCT00591838|Primary|Phase I Portion Only: Number of Participants With Late Treatment Related Grade 3-5 Toxicity|"CTCAE version 3.0 will be used to grade toxicity~Late toxicity are adverse events that occur from Day 91 through 2 years"|91 days to 2 years|-Phase I participants were the only participants evaluable for this outcome measure|||Participants|||Count of Participants
2790360|NCT00591838|Primary|Phase I Portion Only: Number of Participants With Acute Treatment Related Grade 3-5 Toxicity|"CTCAE version 3.0 will be used to grade toxicity~Acute toxicity are adverse events that occur from start of treatment through 90 days"|Up to 90 days|-Phase I participants were the only evaluable participants for this outcome measure.|||Participants|||Count of Participants
2790361|NCT00591838|Primary|Phase I Portion Only: Determine the Maximum Tolerated Dose of SBRT|"The phase 1 portion had a 5+3 strategy with four escalating dose levels, only one of which was open for accrual at any time. Five patients were accrued to each dose level, and once closed, the next dose level could not be opened until the preceding dose was deemed acceptable. With a minimum of 90 days from the start of RT, if there were no acute grade 3 or 4 non-hematologic toxicities in the five patients, the current dose was deemed acceptable. If one such toxicity was observed, an additional 3 patients were recruited and followed for a minimum of 90 days. If 2 or more such toxicities were observed, the current dose was determined as dose limiting, and the previous dose level was used for the phase 2 portion."|Completion of phase I enrollment (Phase I enrollment took 4 years)|Phase I participants were the only participants evaluable for this outcome measure|||Gy x 5 fractions|||Number
2790362|NCT00591825|Secondary|Cognitive Functioning Measured Using the Wisconsin Card Sorting Task|The Wisconsin Card Sorting Task measures executive functioning and cognitive flexibility. The task uses a deck of 64 cards that the participant must sort according to specified rules. The test is stopped when when six sequences of 10 correct responses have been achieved, or after the deck has been completed twice, which provides a cumulative total of 128 trials. We report the number of errors on the task, which has a range of 0 -128, with a higher score representing worse performance.|2 weeks|Two subjects did not complete the test because they had previous exposure to the test.|||units on a scale||Standard Deviation|Mean
2790363|NCT00591825|Secondary|Cognitive Functioning Measured Using the Iowa Gambling Test|"This test measures a person's emotional decision making. Participants are presented with virtual decks of cards on a computer. Participants are told that each card they draw will win them game money. However, sometimes cards result in losing game money. The task includes 100 trials and the total score represents the number of cards drawn from bad decks as compared to good or safe decks. Thus, the score ranges from -100 to +100, with higher sores representing better performance."|2 weeks||||units on a scale||Standard Deviation|Mean
2790364|NCT00591825|Secondary|Cognitive Functioning Measured Using the Rey-Osterrieth Complex Figure Test (RCFT)|The RCFT assesses the a person's ability to use cues to retrieve information. The test measures visuospatial construction and memory. A person is asked to draw a figure. The figure is broken down into 18 elements. The score is based on their presence, completeness, and correct placement. Each element is scored from 0-2. The Copy, Immediate, and Delay results are scored on a 36 point scale. The higher the score, the better the person performed on the test with a 0 being the minimum and 36 being the maximum score. The organization score is scored according to whether the participant drew five cohesive units of the figure together, for a range of 0-6 and a higher score indicating better organizational performance.|2 weeks||||units on a scale||Standard Deviation|Mean
2790365|NCT00591825|Secondary|Cognitive Functioning Measured Using the Wechsler Memory Scale III (Logical Memory and Faces Subtests)|This scale measures the learning and memory of functioning adults. Logical Memory I and II and Faces I and II subtests were administered to participants. The tasks measure verbal and visual memory, respectively. Scoring is based on the number of story details or faces correctly recalled during immediate (Logical Memory I, Faces I) and 30 minute delayed (Logical Memory II, Faces II) conditions. Total score ranges from 0-75 on Logical Memory I, 0-50 on Logical Memory II, 0-48 on Faces I, and 0-48 on Faces II. For all subtests, higher scores indicate better memory performance.|2 Weeks||||units on a scale||Standard Deviation|Mean
2790366|NCT00591825|Primary|fMRI Brain Activations During Symptom Provocation|Regions of interest (ROIs) were specified based on previous research and included amygdala, insula, dorsal anterior cingulate cortex (ACC), dorsolateral PFC (dlPFC), and hippocampus. Multiple regression analyses were used to examine differences in response between experimental conditions (spider versus butterfly images). For significant clusters of activation within ROIs, the average max percent signal change is reported. For other regions, the average max percent signal change is reported within a sphere centered at coordinates identified via previous research.|2 Weeks|There were 54 enrolled in the study. 8 subjects were excluded from fMRI analyses: 1 for claustrophobia, 3 for scanner artifact, 1 because of motion >3mm; 3 of paradigm-consistent motion which could not be corrected for.|||percent signal change||Standard Deviation|Mean
2790367|NCT00591786|Secondary|Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF Stimulation|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|Up to 194:45 (min:sec)|The analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.|||Minutes||Standard Deviation|Mean
2790368|NCT00591786|Secondary|Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF Stimulation|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|Up to 152:30 (min:sec)|The analysis population was the Per-Protocol (PP) group, which consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.|||Minutes||Standard Deviation|Mean
2790369|NCT00591786|Primary|Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|Up to 269:45 (min:sec)|The analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.|||Minutes||Standard Deviation|Mean
2790370|NCT00591773|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790371|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 , defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790372|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790373|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790374|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790375|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790426|NCT00591344|Secondary|Functional Reach|The distance one can reach forward without taking a step.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790376|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790377|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790378|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790379|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790380|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790381|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790382|NCT00591773|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790383|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790384|NCT00591773|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790385|NCT00591760|Primary|Peak VO2|changes in peak VO2|6 months||||ml/kg/min||Standard Error|Mean
2790386|NCT00591734|Secondary|Objective Response Rate|The percentage of patients who experience an objective benefit from treatment|13 months|||||||
2790387|NCT00591734|Secondary|Overall Survival|The length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months|||||||
2790388|NCT00591734|Primary|Progression-free Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|13 months||||months||95% Confidence Interval|Median
2790389|NCT00591721|Primary|Change From Baseline in Subscale Scores of the Fatigue Impact Scale|"Fatigue impact was measured using the Fatigue Impact Scale (FIS) (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants' responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores"|baseline, 7 weeks (immediate post-intervention)|Intent-to-treat, imputation by maximum likelihood approach|||units on a scale||Standard Deviation|Mean
2790390|NCT00591591|Secondary|Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study||6 hours of sleep||||Number of apnea/hypopnea per sleep hour||Standard Deviation|Mean
2790391|NCT00591591|Primary|Deoxy-Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.|||µM||Standard Deviation|Mean
2790392|NCT00591591|Primary|Total Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep||||µM||Standard Deviation|Mean
2790393|NCT00591591|Primary|Oxyhemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.|||µM||Standard Deviation|Mean
2790427|NCT00591344|Secondary|Berg Balance Scale Score|This is a overall measure of balance|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790395|NCT00591578|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790396|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790397|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 24, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790398|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790399|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790400|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790401|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790402|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790403|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790404|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790405|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790406|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790407|NCT00591578|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790408|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790409|NCT00591578|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790410|NCT00591565|Primary|Change From Baseline at 8 Weeks in the HAM-A Scale|this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).|baseline and 8wk|LOCF if two initial visits were completed|||units on a scale||Standard Deviation|Mean
2790411|NCT00591409|Secondary|Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)|All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.|||Minutes||Standard Deviation|Mean
2790412|NCT00591409|Secondary|Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)|All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.|||Minutes||Standard Deviation|Mean
2790413|NCT00591409|Primary|Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)|All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.|||Minutes||Standard Deviation|Mean
2790414|NCT00591370|Secondary|Duration of Objective Clinical Responses|Duration of Response (Objective Clinical Responses)|24 weeks after ending treatment||||months||Full Range|Median
2790415|NCT00591370|Secondary|Overall Survival|Overall survival at 18 months post treatment|18 months after ending treatment||||percentage of participants|||Number
2790416|NCT00591370|Primary|Determine the Overall Objective Response Rate (CR and PR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From start of treatment through 24 weeks after ending treatment||||participants|||Number
2790417|NCT00591344|Secondary|5 Time Sit to Stand|The time it takes to stand up and sit down five times|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790418|NCT00591344|Secondary|50 Foot Walk Speed|The speed that aerson walks over 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790419|NCT00591344|Secondary|50 ft Walk Time|Time it takes to walk 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790420|NCT00591344|Secondary|Beck's Depression Inventory|This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790421|NCT00591344|Secondary|Epworth Sleepiness Scale|The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790422|NCT00591344|Secondary|Parkinson 's Disease Quality of Life|PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790423|NCT00591344|Secondary|Cognitive Function - Digit Span Forward/Backward|This tests a persons ability to remember that were read to them both forward and then backwards.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790424|NCT00591344|Secondary|Cognitive Function - Brief Test of Attention|This is a cognitive test of an individuals ability to remember number. It is a test of working memory.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790428|NCT00591344|Secondary|Time on the Timed up and go Test|This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790429|NCT00591344|Secondary|Modified Physical Performance Test|This is an overall measure of physical fuction|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790430|NCT00591344|Secondary|Distance Walked in 6 Minutes|This is how far an individual can walk in 6 minutes|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790431|NCT00591344|Secondary|Spatiotemporal Gait Analysis|Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790432|NCT00591344|Secondary|Rise Time|This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790433|NCT00591344|Secondary|Relaxation Time|Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790434|NCT00591344|Secondary|Peak Movement Velocity|This is how fast an individual can perform a 72 degree elbow flexion movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790435|NCT00591344|Secondary|Time to Peak Velocity|Time of the onset of the movement to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790436|NCT00591344|Secondary|Qant|The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790437|NCT00591344|Secondary|Co-contraction During Limb Acceleration|the amount of agonist and antagonist activity present during limb acceleration.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790438|NCT00591344|Secondary|Number of Agonist Bursts|This is the number of agonist bursts prior to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790439|NCT00591344|Secondary|Duration of First Agonist Burst|Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790440|NCT00591344|Secondary|Magnitude of the Agonist Burst|Magnitude of the agonist burst reflects the amount of agonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790441|NCT00591344|Secondary|Magnitude of the Antagonist Burst|the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790442|NCT00591344|Secondary|Magnitude of the First 30 ms of the Agonist Burst|The integral of the first 30 msec of the agonist EMG.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790443|NCT00591344|Secondary|The Integral of the First Agonist Burst|The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790444|NCT00591344|Secondary|Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions|This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790445|NCT00591344|Secondary|Ankle Dorsiflexion Strength|This is a measure of the MVC for ankle dorsiflexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790446|NCT00591344|Secondary|Elbow Extension Strength|This is a measure of the MVC for elbow extension|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790447|NCT00591344|Secondary|Ankle Plantar Flexion Strength|This is a measure of the MVC for ankle plantar flexion strength|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790448|NCT00591344|Secondary|Elbow Flexion Strength|This is the MVC for elbow flexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||||||
2790449|NCT00591344|Secondary|L-dopa equivalent-mg/Day|This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||mg/day||Standard Deviation|Mean
2790450|NCT00591344|Secondary|On Medication UPDRS-III|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||units on a scale||Standard Deviation|Mean
2790451|NCT00591344|Primary|Off Medication UPDRS Part III, Motor Subscale Score|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||units on a scale||Standard Deviation|Mean
2790575|NCT00590460|Secondary|Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)|Number of patients with grade II - IV acute Graft versus Host Disease (GVHD)|100 days||||participants|||Number
2790452|NCT00591305|Secondary|Estradiol Level in Blood Post Treatment|determine side-effect by comparing Estradiol level in blood before and after treatment|5 month|failure for any meaningful analysis as only 1 participant in this study|||pg/ml|||Number
2790453|NCT00591305|Secondary|Estradiol Level in Blood Pre Treatment|determine side-effect by comparing Estradiol level in blood before and after treatment|Before treatment at baseline|failure for any meaningful analysis as only 1 participant in this study|||pg/ml|||Number
2790454|NCT00591305|Primary|Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months|vocal lesion size and area after 5 month with surgery visible lesion found in >50% of the treated tissue area, after surgery|Recurrence of pailloma at 5 months|participants received at least one of two interventions|||case|||Number
2790455|NCT00591266|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790456|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790457|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6 relative to baseline, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790458|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790459|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790460|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790461|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790462|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790463|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790464|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790465|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790521|NCT00590824|Secondary|In Vitro Soluble Interleukin-2 (IL2) Receptor Alpha Levels|Soluble IL2 receptor α levels will be performed on participants approximately 10 minutes prior to initiation of treatment, and serum samples on Days 3, 4, 8, and 29/1.|up to 12 weeks||||ng/ml||Standard Error|Mean
2790466|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790467|NCT00591266|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790468|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790469|NCT00591266|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790470|NCT00591253|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790471|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790472|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||percentage of participants|||Number
2790473|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790474|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790475|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790476|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790477|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790478|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790540|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).|||Liter x min||Standard Deviation|Mean
2790479|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790480|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790481|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790482|NCT00591253|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790483|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2790484|NCT00591253|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2790485|NCT00591240|Primary|Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.|"Study 1: Multiplex pathogen identification using biosensor based assay. We recruited 116 participants yielding 109 urine samples suitable for analysis and comparison between biosensor assays and standard urine culture. Biosensor based assays were used to detect multiple pathogens in the urine samples.~Study 2: Antimicrobial susceptibility testing using biosensor based assay. We recruited 222 participants yielding 252 urine samples. Corresponding biosensor and clinical microbiology culture data was available for 215 samples. 73% (157) of these samples contained bacteria. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples."|Up to 1.5 years|Urine samples were collected from participants at the Spinal Cord Injury Service for assay validation.|||percentage of urine specimen|Participants||Number
2790486|NCT00591227|Primary|Hospital Length of Stay|hospital length of stay in days|days||||days||95% Confidence Interval|Mean
2790487|NCT00591227|Secondary|Frequency of Hypoglycemia During Emergency Room Therapy With Insulin||from emergency room admission to discharge|||||||
2790488|NCT00591227|Secondary|Efficacy of Blood Glucose Lowering During the Emergency Room Stay||from emergency room admission to discharge|||||||
2790489|NCT00591227|Secondary|Frequency of Hypoglycemia||from hospital admission to discharge|||||||
2790490|NCT00591227|Secondary|Average Blood Glucose During the Hospital Admission||from admission to discharge|||||||
2790491|NCT00591227|Primary|Length of Stay in the Hospital||from hospital admission to hospital discharge|||||||
2790492|NCT00591214|Secondary|Change in HCV RNA Levels of MP-424|"Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86.~Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose))."|Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86||||Log IU / mL||Standard Deviation|Mean
2790493|NCT00591214|Primary|t1/2 (Half Life Period) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||hours||Standard Deviation|Mean
2790494|NCT00591214|Primary|Ctrough (Plasma Trough Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||μg/mL||Standard Deviation|Mean
2790495|NCT00591214|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||μg x h /mL||Standard Deviation|Mean
2790496|NCT00591214|Primary|Tmax (Time of Maximum Plasma Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||hours||Full Range|Median
2790497|NCT00591214|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85||||μg / mL||Standard Deviation|Mean
2790498|NCT00591149|Primary|Efficacy Measured by Response Rate in Participants|"Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI:~Complete Response (CR), Disappearance of all target lesions;~Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;~Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started;~Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|12 Weeks, 1 Year||||participants|||Number
2790499|NCT00591019|Secondary|Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.|Simple reaction time to an auditory signal is a measure of attention.|5 weeks||||milli seconds||Standard Error|Mean
2790500|NCT00591019|Primary|The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).|P50 is an auditory evoked response potential sensitive to states of arousal.|5 weeks||||milli volts||Standard Error|Mean
2790501|NCT00591006|Secondary|Para-Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition||||percentage of BOLD activation||Standard Deviation|Mean
2790502|NCT00591006|Secondary|Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition||||percentage of BOLD activation||Standard Deviation|Mean
2790503|NCT00591006|Primary|Difference in RAVLT Total T-Score Between Treatments|The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information. Test raw scores are converted to T-scores. T-scores have a mean of 30 ± 10 where higher scores are indicative of better verbal memory. Total T-score differences following study treatment interventions are reported.|At end of each treatment condition (on average 21 days between treatments)||||T-score||Standard Error|Mean
2790504|NCT00590980|Primary|Fatal and Nonfatal Ischemic Stroke in the Vertebrobasilar Territory|Definite fatal and nonfatal ischemic stroke in the vertebrobasilar territory|up to 27 months|Study participants meeting all inclusion and exclusion criteria|||Participants|||Count of Participants
2790505|NCT00590967|Secondary|Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis||5 years after completion of radiation therapy|The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed.||||||
2790506|NCT00590967|Primary|Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status||1st PET scan after completion of treatment (approximately month 6)||||participants|||Number
2790507|NCT00590967|Primary|Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)||30 days after completion of radiation therapy||||participants|||Number
2790508|NCT00590967|Primary|Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity|-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|1 year post start of radiation therapy||||participants|||Number
2790509|NCT00590902|Primary|Overall Objective Response of OSI-774|(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|53 weeks||||participants|||Number
2790510|NCT00590889|Primary|Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.|Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.|1 year|subjects randomized into the study|||participants|||Number
2790511|NCT00590863|Secondary|Quality of Life Inventory|The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life.|Measured at Month 7||||units on a scale||Standard Deviation|Mean
2790512|NCT00590863|Primary|Quick Inventory of Depressive Symptoms|Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).|Measured at Month 7|Remission = Last 2 QIDS < 6. A chi-square test was used to compare the remission rates across the treatment groups. The Fisher's exact test was used when expected cell frequencies were <5. For binary outcomes (e.g., remission), bivariate logistic regression models were fit to estimate the effect of treatment on outcome.|||percentage of participants|||Number
2790513|NCT00590824|Other Pre-specified|Antibody Dependent Cellular Cytotoxicity (ADCC)|NK and ADCC testing will be done on selected patients with freshly collected peripheral blood mononuclear cell (PBMC) at baseline (as a control), on day 8 of Courses 2 and 3, and on day 29/1 of Courses 2 and 3.|up to 12 weeks|||||||
2790514|NCT00590824|Other Pre-specified|Natural Killer Cells (NK)|NK and ADCC testing will be done on selected patients with freshly collected peripheral blood mononuclear cell (PBMC) at baseline (as a control), on day 8 of Courses 2 and 3, and on day 29/1 of Courses 2 and 3.|up to 12 weeks|||||||
2790515|NCT00590824|Other Pre-specified|Expression of GD2 Target Antigen||Up to 1 week|||||||
2790516|NCT00590824|Other Pre-specified|Density of Cellular Infiltrate||Up to 1 week|||||||
2790517|NCT00590824|Other Pre-specified|T Cell Reactivity||Up to 1 week|||||||
2790518|NCT00590824|Other Pre-specified|Interferon Gamma (INF-y) Expression||Up to 1 week|||||||
2790519|NCT00590824|Other Pre-specified|Immunocytokine (IC) Binding||up to 1 week|||||||
2790520|NCT00590824|Other Pre-specified|Tumor Vascularity||Up to 1 week|||||||
2790522|NCT00590824|Secondary|Anti-Fc-IL2 Antibodies|Detection of anti-FcIL2 will be performed on participants' serum obtained approximately 10 minutes prior to initiation of treatment, and serum samples on Days 3, 4, 8, and 29/1, for 3 cycles|up to 12 weeks|The investigators determined in real time that the evaluation of anti-Fc-Il2 antibodies was not an appropriate biomarker for this study. The patient generated “anti-drug antibody,” specific for the Fc-IL2 component of the immunocytokine is detected in the standard “anti-idiotypic” bridge assay (reported in Outcome Measure 6).||||||
2790523|NCT00590824|Secondary|Anti-Idiotypic Antibodies|Detection of anti-idiotypic will be performed on participants' serum obtained approximately 10 minutes prior to initiation of treatment, and serum samples on Days 3, 4, 8, and 29/1 of 3 cycles.|up to 12 weeks|Based on data collected from prior trials and analyzed during the time of this trial, the day 3 sample (obtained during hu14.18-IL2 administration) was potentially “masked” by the infusion of the immunocytokine. Anti-immunocytokine antibodies were not typically generated during the initial 5 days when infusions were given on days 1-3.|||Optical Density (OD)||Standard Error|Mean
2790524|NCT00590824|Secondary|Lymphocyte Count|Lymphocyte count measured at baseline, cycle 1 day 3, cycle 1 day 8, and cycle 2 day 1|up to 29 days||||number of lymphocytes||Full Range|Median
2790525|NCT00590824|Secondary|C-Reactive Protein (CRP)|CRP measured at baseline, cycle 1 day 3, and cycle 2 day 1.|up to 29 days||||mg/dL||Full Range|Median
2790526|NCT00590824|Primary|Overall Survival (OS)|OS was defined as the number of days from randomization to the date of the participant's death. Participants who did not experience an event of death at the time of analysis were censored at the date of the last follow-up.|up to 24 months|There was no intent in the protocol to compare OS between Groups A and B.|||months||95% Confidence Interval|Median
2790527|NCT00590824|Primary|Recurrence Free Survival (RFS)|RFS was defined as the number of days from the day of evaluation following course 2 of immunocytokine treatment to the day the subject experienced an event of recurrence or death, whichever occurred first. Participants who did not experience an event of recurrence or death at the time of analysis were censored at the date of the last evaluation for recurrence.|up to 24 months|Two patients in Group B were not treated with adjuvant hu14.18-IL2. Subsequently these two patients were excluded from the RFS analysis. There was no intent in the protocol to compare RFS between Groups A and B.|||months||95% Confidence Interval|Median
2790528|NCT00590824|Primary|Ganglioside Expressed by Tumor Cells (GD2)|Histological analysis of anti-tumor activity is a primary endpoint. This is measured after surgical resection via staining to indicate GD2 expression. The GD2 results were summarized in terms of positive (GD2 expression high or low/moderate) and negative (GD2 expression undetectable).|up to 1 week|There were 12 participants with evaluable tumor samples for GD2 analysis.|||Participants|||Count of Participants
2790529|NCT00590772|Primary|Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks|"Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe.~To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement.~To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement.~For all three above we used data from the last 3 days were averaged and mean of change for each day."|baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2790530|NCT00590759|Secondary|A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.|Proportion of subjects in TAG 05-02 with MAEs|5 years||||participants|||Number
2790531|NCT00590759|Primary|Aneurysm Related Death|Freedom from aneurysm related mortality for TAG 05-02 subjects|5 years||||participants|||Number
2790532|NCT00590720|Secondary|Accumulation Index|Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528|Days 0 and 24|All participants who received at least one dose of MEDI-528 (n=7) and had available data (n=5).|||Ratio||Standard Deviation|Mean
2790533|NCT00590720|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.|||Day||Standard Deviation|Mean
2790534|NCT00590720|Secondary|Mean Trough Concentration at Last Measurable Time Point (Cmin_last)|Cmin_last of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.|||Microgram per milliliter||Standard Deviation|Mean
2790535|NCT00590720|Secondary|Mean Trough Concentration (Cmin)|Cmin of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.|||Microgram per milliliter||Standard Deviation|Mean
2790536|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Minutes||Standard Deviation|Mean
2790537|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Minutes||Standard Deviation|Mean
2790538|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=9, 2 placebo and 7 MEDI-528).|||Minutes||Standard Deviation|Mean
2790539|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).|||Liter x min||Standard Deviation|Mean
2790541|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Liter x min||Standard Deviation|Mean
2790542|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Percent change||Standard Deviation|Mean
2790543|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Percent change||Standard Deviation|Mean
2790544|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, 2 placebo and 7 MEDI-528).|||Percent change||Standard Deviation|Mean
2790545|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Liter||Standard Deviation|Mean
2790546|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).|||Liter||Standard Deviation|Mean
2790547|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, with 2 placebo and 7 MEDI-528).|||Liter||Standard Deviation|Mean
2790548|NCT00590720|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 119, and 150|All participants who received at least one dose of MEDI-528.|||Participants|||Number
2790549|NCT00590720|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).|||Participants|||Number
2790550|NCT00590720|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).|||Participants|||Number
2790551|NCT00590707|Secondary|Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score|"Clinical Dementia Rating consists of 6 domains (boxes) of function: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain (box) is rated on a 5-point scale (0= no impairment, 0.5=questionable impairment, 1= mild impairment, 2= moderated impairment, 3= severe impairment. The CDR-SOB score is a sum of these ratings, for a total Sum of boxes ranging from 0-18, where 0=cognitively intact. Increasing sum of boxes score is associated with greater cognitive impairment."|12 months post-operative||||units on a scale||Standard Deviation|Mean
2790552|NCT00590707|Secondary|Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method|The presence of delirium is assessed by the confusion assessment method (CAM), after 1 month postoperative. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.|1 month (30 days) post-intervention||||Participants|||Count of Participants
2790553|NCT00590707|Secondary|Mortality|death occurring during follow-up period, in one year post-op.|12 months post-operative||||Participants|||Count of Participants
2790554|NCT00590707|Secondary|Change in Functional Status|Ability to perform Activities of Daily Living (ADL) using 6-point Katz activities of daily living scale, assessed at 12 months post-op. The range of the Katz activities of daily living scale is from 0-6, 0 is worse and 6 is best.|12 months post-operative|ADL score at 1 year|||units on a scale||Standard Deviation|Mean
2790555|NCT00590707|Primary|Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method|The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.|Postoperative days up to hospital discharge||||Participants|||Count of Participants
2790556|NCT00590590|Secondary|Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]||12 Weeks||||Score||Standard Error|Mean
2790557|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]||12 Weeks||||Score||Standard Error|Mean
2790558|NCT00590590|Secondary|Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]||12 weeks||||Score||Standard Error|Mean
2790559|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]||12 Weeks||||Score||Standard Error|Mean
2790560|NCT00590590|Secondary|Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)|0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse|Baseline -12 Weeks||||Score||Standard Error|Mean
2790561|NCT00590590|Primary|Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)|The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse|12 weeks||||scores on a scale||Standard Error|Mean
2790562|NCT00590577|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment|The CGI-S rating scale was used to assess the severity of a subject's overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst. The change in CGI-S score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.|||Scores on a scale||Full Range|Median
2790563|NCT00590577|Secondary|Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.|The PSP scale measures the degree of normal function of a subject in interpersonal relationships and social interactions. Scores range from 1 to 100, where 1 is worst and 100 is best. The average change in PSP score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.|||Scores on a scale||Standard Deviation|Mean
2790564|NCT00590577|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment|The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The primary outcome measure used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.|||Scores on a scale||Standard Deviation|Mean
2790565|NCT00590564|Primary|To Determine the Effects of Sho-saiko-to on Hepatic Injury in Patients With Chronic Hepatitis C Who Are Intolerant or Have a Specific Contraindication to Interferon-based Therapy.|Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy|52 weeks||||participants|||Number
2790566|NCT00590538|Secondary|Number of Participants With Abnormal Laboratory Safety Tests|Outcome measure will be obtained by completion of routine metabolic and hematological laboratory parameters for every participant. Metabolic testing willl include a CMP (comprehensive metabolic panel, ALT (alanine aminotransferase test), GGT (gamma-glutamyl transpeptidase), and Uric Acid; Hematological testing will include a complete blood count (CBC), and partial thromboplastin (PT/PTT).|up to 2 weeks|No analysis was completed on data collected; More clinically efficacious compounds have been identified which suggested that completion of this study might not be as critical as when initially proposed; therefore, the study was terminated by PI.|||participants|||Number
2790567|NCT00590538|Secondary|Number of Participants With Adverse Events|Adverse Events will be assessed and outcome measure obtained by completion of Interval history, physical and mental status examinations of every participant.|up to 2 weeks||||participants|||Number
2790568|NCT00590538|Secondary|Change in FVC (Forced Vital Capacity)in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.|||Liters|||Number
2790569|NCT00590538|Secondary|Change in FEV1 (Forced Expiratory Volume in 1 Second) in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.|||Liters|||Number
2790570|NCT00590538|Primary|Change in Voltage (mVolt) in Nasal Epithelium|"The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF Nasal Potential Difference (NPD) Protocol compared to a modified NPD protocol including the perfusion of Genistein.~The NPD response will be compared from baseline to after study drug. NPD responses will then be compared between the Phenylbutrate group and the placebo group."|Baseline and 2 weeks|No analysis was completed on data collected; AND study was never unblinded therefore details not available.|||mVolts|||Number
2790571|NCT00590460|Secondary|Patients With Grade III - IV Acute GVHD|Number of patients with Grade III-IV acute GVHD|100 days||||participants|||Number
2790572|NCT00590460|Secondary|Patients With Extensive Chronic GVHD From Day 100 to 365|Number of patients with extensive chronic GVHD from day 100 to 365.|365 days||||participants|||Number
2790576|NCT00590460|Secondary|Days to Platelet Count of 20,000/mm3 Without Transfusions|Number of days to Platelet count of 20,000 / mm3 without transfusions|30 Days|Participants achieved a platelet count of 20,000 / mm3 without transfusions.|||days||Full Range|Median
2790577|NCT00590460|Secondary|Days to Absolute Neutrophil Count (ANC) of 500/mm3|Number of days to Absolute neutrophil count (ANC) of 500/mm3|30 Days||||days||Full Range|Median
2790578|NCT00590460|Secondary|Patients With Treated Related Death|Number of patients with treated related death|100 days||||participants|||Number
2790579|NCT00590460|Secondary|Number of Patients With Graft Failure|Graft failure is defined as engraftment of less than 65% of donor cells 100 days after transplantation.|100 days||||participants|||Number
2790580|NCT00590460|Primary|Number of Patients With Donor Engraftment|Number of patients with engraftment of at least 65% of donor cells 100 days after transplantation|100 Days||||participants|||Number
2790581|NCT00590395|Primary|Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis|"Percent of patients identified of having cholecystitis using FDG PET/CT compared to patients identified of having pathological diagnosis of cholecystitis (sensitivity) Percent of patients identified of not having cholecystitis using FDG PET/CT compared to patients identified of not having pathological diagnosis of cholecystitis (specificity)~number of false positives = number of patients incorrectly identified of having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis.~number of false negatives = number of patients incorrectly identified of not having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis.~number of true positives = number of patients correctly identified of having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis.~number of true negatives = number of patients correctly identified of not having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis."|1-2 days through the post operative period|All patients|||Participants|||Count of Participants
2790582|NCT00590369|Secondary|Patient Reported Pain|scale of 0= no pain to 10= worst pain possible|at first dressing change; generally 48 hours||||units on a scale||Standard Deviation|Mean
2790583|NCT00590369|Secondary|Nursing Time||hospital stay; generally 6 days||||minutes||Standard Deviation|Mean
2790584|NCT00590369|Secondary|Cost of Wound Care|cost of device/supplies used in application and dressing changes|during hospital stay; generally 6 days||||dollars (USD)||Standard Deviation|Mean
2790585|NCT00590369|Secondary|Ease of Providing Nursing Care|nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem|during hospital stay; generally 6 days||||scores on a scale||Inter-Quartile Range|Median
2790586|NCT00590369|Secondary|Ease of Performing Dressing Change|responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do|during hospital stay; generally 6 days||||scores on a scale||Inter-Quartile Range|Median
2790587|NCT00590369|Primary|5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling|differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler|first dressing change; typically within 48 hours||||centimeters||Inter-Quartile Range|Median
2790588|NCT00590317|Secondary|Akithisia at 0 to 120 Min||0 to 120 min after receiving medication||||no. participants exp akathisia|||Number
2790589|NCT00590317|Secondary|Nausea at 0 to 120 Min|100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea|0 to 120 minutes after receiving medication||||units on a scale||Standard Deviation|Geometric Mean
2790590|NCT00590317|Primary|Vomiting at 0 to 120 Min.||0 to 120 minutes after receiving medication|Convenience sample|||number of participants exp vomiting|||Number
2790591|NCT00590226|Secondary|Number of Patients With Hypoglycemic Events|number of patients with hypoglycemic events as defined as BG 40-59 mg/dl|during hospitalization||||participants|||Number
2790592|NCT00590226|Primary|Mean AM BG (mg/dl)|average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2|during hospitalization||||mg/dl||Standard Deviation|Mean
2790593|NCT00590161|Primary|Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year.|The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).|1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo)|Intention to treat analysis included all participants and for this analysis patients without available end of study liver biopsy were imputed as treatment failures. Results showed here are continuous variable analysis of NAS score change in patients with available end of study liver biopsy (per protocol analysis)|||NAS score units||Standard Deviation|Mean
2790594|NCT00590135|Secondary|Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.||||||
2790595|NCT00590135|Secondary|Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.||||||
2790596|NCT00590135|Secondary|Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.|2 years|Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.||||||
2790597|NCT00590135|Secondary|Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls|Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.|2 years|Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.||||||
2790598|NCT00590135|Primary|Aortic Stenosis|aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility|2 years|Population had aortic stenosis, however the primary endpoint of Aortic Valve Area was not obtainable due to poor reproducibility. As a result, the study was terminated.||||||
2790599|NCT00590044|Secondary|Difference in Time in Hours to Resolution of DKA Between the 2 Groups|The mean duration of treatment until resolution of ketoacidosis is measured and compared between the 2 groups. The DKA was considered resolved when blood glucose was 250 mg/dl, the serum bicarbonate level was <18 mmol/l, and venous phenol hydroxylase (pH) was 7.30. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.|up to 20 hours||||hours||Standard Deviation|Mean
2790600|NCT00590044|Secondary|Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups|To determine the differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA) before transitioning to subcutaneous insulin. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.|up to 20 hours||||mg/dL||Standard Deviation|Mean
2790601|NCT00590044|Secondary|Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin|The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed Identification (ID): 19366972.|Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin||||mg/dl||Standard Deviation|Mean
2790602|NCT00590044|Primary|Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups|To determine the safety of the two treatments the number of hypoglycemia episodes that occurred between the 2 groups are measured from the time of transitioning to subcutaneous insulin to day 5. The hypoglycemia events are defined as blood glucose levels <70 mg/dL. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.|5 days after transitioning to subcutaneous insulin||||number of hypoglycemia episodes|||Number
2790603|NCT00590031|Secondary|Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality||2 years||||participants|||Number
2790604|NCT00590031|Primary|Pathologic Complete Response|Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.|2 years||||participants|||Number
2790605|NCT00590018|Secondary|Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.|Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85.|2 days||||units on a scale||Standard Deviation|Mean
2790606|NCT00590018|Primary|Blood Pressure.|Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).|2 days||||mmHg||Standard Deviation|Mean
2790607|NCT00590005|Secondary|Reduction in Breath pH|Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.|baseline and 21 days|225 children with asthma were enrolled in the study and completed baseline assessments. Only 40 children were followed longitudinally. The data from those 40 children are shown here.|||log of hydrogen ion concentration (pH)||Standard Deviation|Mean
2790608|NCT00590005|Primary|Exhaled Nitric Oxide at Baseline and Over the Observational Period|Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag|baseline and after 21 days|225 children were enrolled into the study and completed baseline assessments. Only 40 children were followed longitudinally. The results from only those 40 children are shown here.|||parts per billion||Standard Deviation|Mean
2790609|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale|The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient's sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)[maximum score = 700], effectiveness (which measures how well sleep refreshed the individual) [maximum score = 600], and supplementation (which measures the need for napping) [maximum score = 400]. The higher the score the greater the value of the sleep characteristic for that patient.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790610|NCT00589979|Other Pre-specified|Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790611|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790612|NCT00589979|Secondary|Investigator Global Assessment of Treatment Satisfaction|At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790613|NCT00589979|Secondary|Patient Global Assessment of Treatment Satisfaction|At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790614|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline (Day 0) and at each clinic visit (at least every 4 weeks) or at premature discontinuation. Values of the EQ-5D index score range from -1 (worst) to 1 (best).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790615|NCT00589979|Other Pre-specified|Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790643|NCT00589797|Primary|Neurological Success|Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
2790644|NCT00589797|Primary|Range of Motion (ROM) Success|Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
2790616|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Baseline and end of treatment period (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790617|NCT00589979|Secondary|Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from very much worse to very much improved. A similar questionnaire was completed by the Investigator."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790618|NCT00589979|Secondary|Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: very much worse (0); much worse (1); minimally worse (2); no change (3); minimally improved (4); much improved (5); and very much improved (6)."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790619|NCT00589979|Secondary|Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores|The PQAS measures individual pain qualities and the impact of treatment on those qualities. Items 1-19 are each rated on an 11-point scale ranging from 0 (lowest score - no pain of that type) to 10 (highest score - the highest level of that type of pain). Average surface pain = average of PQAS items: cold, sensitive, itchy, numb, and tingling. Average deep pain = average of PQAS items: dull, cramping, throbbing, aching, and heavy. Average paroxymal pain = average of PQAS items: sharp, shooting, electric, and radiating.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790620|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores|The Pain Relief Scale (PRS) is a 9-point categorical rating scale to assess pain relief during the 24-hours since the last assessment; 0= completely worse and 8= complete pain relief. Patients completed this assessment each day during the run-in period and each day during the double-blind treatment phase in their e-diary.|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790621|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)|"The Numerical Rating Scale (NRS) is an 11-point categorical rating scale to assess pain intensity (PI-NRS); 0= no pain and 10= worst possible pain. The scale is anchored on the left with No Pain and on the right with Worst Possible Pain. Patients were to complete this assessment at approximately the same time each day during the double-blind treatment period in their e-diary. The overall treatment difference for the Lidoderm (lidocaine patch 5%) and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence."|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Units on a scale||Standard Error|Least Squares Mean
2790622|NCT00589979|Secondary|Exit Status From Current Study Treatment - Yes|Exit status from a current study treatment was categorized as yes or no for patients who exited prior to the 4-week planned duration. This analysis supports the results of the primary analysis. The number of patients exiting (yes) is reported.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.|||Participants|||Number
2790645|NCT00589797|Primary|Absence of Serious Device Related Adverse Events|Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
2790646|NCT00589797|Primary|Device Success|Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
2790787|NCT00588666|Secondary|The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.||3 years||||percentage of participants|||Number
2790623|NCT00589979|Secondary|Time-to-Exit Due to Lack of Efficacy|"Time-to-exit due to lack of efficacy was defined as a patient that met the switching criterion (a 2-category change in Pain Relief Scale (PRS) in the worsening direction [increasing pain or decreasing pain relief] for 2 consecutive days) or was discontinued from the current period or study due to lack of efficacy. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief.~No patients discontinued from the study due to lack of efficacy."|Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: No patients exited a study period due to lack of efficacy, therefore median time-to-exit could not be calculated."|||days||95% Confidence Interval|Median
2790624|NCT00589979|Primary|Time-to-Exit From Current Study Treatment|Time-to-exit was defined as the number of days at which a patient either met the switching criterion [a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.|Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: Kaplan-Meier estimates for median time-to-exit from current study treatment could not be calculated for Period 2 or Period 3, because the survival distribution function did not fall below 0.5000."|||Days||95% Confidence Interval|Median
2790625|NCT00589914|Secondary|The Change From Baseline in the PSP Score|The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.|||Scores on a scale||Standard Deviation|Mean
2790626|NCT00589914|Secondary|The Change From Baseline for the CGI-S Score|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time. A qualified rater administered the CGI-S.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.|||Scores on a scale||Standard Deviation|Mean
2790627|NCT00589914|Primary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia|The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The per-protocol analysis set of patients included those randomized to treatment after IEC/ IRB approval of protocol Amendment INT-4 with both a baseline measurement and at least 1 postrandomization measurement on the primary efficacy variable, a minimum exposure of 36 days to the double-blind treatment regimen, and no major protocol violations.|||Scores on a scale||Standard Deviation|Mean
2790628|NCT00589888|Secondary|Change in Blood Insulin Levels From Baseline to After Intervention Among the Normal Obese Subjects|Insulin is an anabolic hormone that promotes glucose uptake, glycogenesis, lipogenesis, and protein synthesis of skeletal muscle and fat tissue through the tyrosine kinase receptor pathway. In addition, insulin is the most important factor in the regulation of plasma glucose homeostasis, as it counteracts glucagon and other catabolic hormones like epinephrine, glucocorticoid, and growth hormone. Normal fasting insulin levels is < 25 milli-International unit/litre|Baseline and at the end of the 8-hours|the same 13 subjects underwent different interventions in random order on different occasions|||milli-International unit /Litre||Standard Deviation|Mean
2790629|NCT00589888|Secondary|Change in C-peptide Concentration Levels From Baseline to After Specific Intervention Among the Healthy Obese Subjects|"C-peptide is a peptide composed of 31 amino acids. It is released from the pancreatic beta-cells during cleavage of insulin from proinsulin. It is mainly excreted by the kidney, and its half-life is 3-4 times longer than that of insulin. The reference range of C-peptide is 0. 8-3 ng/ml. The C-peptide test is a tool to monitor and treat diabetes. It shows how well your body makes insulin, which moves sugar (or glucose) from your blood into your cells."|baseline and after 8 hours after admission||||ng/ml||Standard Deviation|Mean
2790630|NCT00589888|Secondary|Change in Blood Glucose Levels From Baseline to 6-8 Hours After Intervention Among Obese Healthy Subjects|The blood glucose level is the amount of glucose present in the blood of humans. Many factors affect a person's blood sugar level. The body's homeostatic mechanism of blood sugar regulation (known as glucose homeostasis), when operating normally, restores the blood sugar level to a narrow range of about 4.4 to 6.1 mmol/L (79 to 110 mg/dL) (as measured by a fasting blood glucose test). The study aims to study the effects of these interventions on blood glucose levels among obese healthy subjects.|Baseline and at the end of the 8-hours||||mg/dL||Standard Deviation|Mean
2790647|NCT00589797|Secondary|VAS Success for Back and Leg Pain at Rest|Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline|24 months|Intent to treat population; observed data (i.e. missing data not imputed as failures)|||participants|||Number
2790984|NCT00586703|Secondary|Efficacy - Overall Survival|Evaluate the efficacy of the regimen in terms of overall survival (OS).|7 years|Participants who completed infusion.|||months||Full Range|Mean
2790631|NCT00589888|Secondary|Change in Flow-mediated Dilation (FMD) of Endothelium-dependent Brachial Artery From Baseline to After Completing a Specific Intervention in Obese Normotensive Subjects.|Endothelium-dependent brachial artery dilatation was assessed as a measurement of endothelial function using established methodology. Briefly, ultrasound images of the brachial artery were obtained at baseline under standardized conditions and 60 s after induction of reactive hyperemia by 5-min cuff occlusion of the forearm. Image landmarks as well as surface markers were utilized to ensure anatomic consistency between serial imaging studies. All images were digitized online, and arterial diameters were measured with customized software by individuals blinded to the clinical and laboratory status of the subjects. Flow-mediated dilatation (FMD) was expressed as the percentage increase in diameter from baseline. It is measured in percentage.|Baseline and at the end of the 8-hours||||percentage of FMD||Standard Deviation|Mean
2790632|NCT00589888|Primary|Changes in Systolic Blood Pressure From Baseline to After Completing an Oral 64-gram Fat Load in Obese Normotensive Subjects|To study the effects of high dose oral fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|at the end of the 8 hours||||mmHg||Standard Deviation|Mean
2790633|NCT00589888|Primary|Change in Systolic Blood Pressure From Baseline to After Completing an Oral 32-gram Fat Load in Obese Normotensive Subjects.|To study the effects of oral low dose fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position.The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
2790634|NCT00589888|Primary|Changes in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 40cc/hr Infusion in Obese Normotensive Subjects|To study the effects of high dose intravenous (IV) fat infusion on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at every 2 hours till the end of infusion. The BP from the admission are compared to BP after the infusion. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
2790635|NCT00589888|Primary|Change in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 20cc/hr Infusion in Obese Normotensive Subjects.|To study the effects of low dose intravenous (IV) fat infusion on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at every 2 hours till the end of infusion. The BP from the admission are compared to BP after the infusion.A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
2790636|NCT00589888|Primary|Change in Systolic Blood Pressure to After Completing an 8-hour Normal Saline Infusion in Obese Normotensive Subjects.|To study the effects of high dose oral fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.|Baseline and at the end of the 8-hours||||mmHg||Standard Deviation|Mean
2790637|NCT00589849|Primary|Event Free Survival at 1 Year|Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year|12 months||||participants|||Number
2790638|NCT00589849|Primary|Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI||30 days|||||||
2790639|NCT00589836|Primary|Accuracy of Doppler Tissue Imaging|"The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.~LV torsion reflects the torsion (twisting deformation) occurring across the length of the ventricle (from the base to the apex) during the time interval defined by the beginning and end of contraction (or in physiologic terms, from end -diastole to end systole). In this study, end diastole was defined by the R wave of the ECG, while end systole is defined by minimum end-systolic volume or maximum of twisting deformation. The deformation is measured in degrees.~Once the measurements are performed by experimental method (i.e. TDI imaging) and reference method (i.e. MRI imaging) these two methods are then compared using Bland Altman analysis.~In a current study, mean difference between methods of torsion quantification was 0.57 degrees, while the standard deviation (SD) was 1.98 degrees."|1 1/2 hours|population had both MRI and DTI on the same day.|||degrees||Standard Deviation|Mean
2790640|NCT00589797|Secondary|Improvement in SF-36 Scores|Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline|24 months|Intent to treat population; observational data (i.e. missing data not imputed as failures)|||participants|||Number
2790641|NCT00589797|Secondary|ODI Success Using Two Measures of Success|Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline|24 months|Intent to treat population; observational data (i.e. missing data not imputed as failures)|||participants|||Number
2790642|NCT00589797|Primary|ODI Success|Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
2790648|NCT00589797|Primary|Overall Success at 24 Months Relative to Baseline|Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.|24 months|Intent to treat population; missing data imputed as failures|||percentage of participants||95% Confidence Interval|Number
2790649|NCT00589784|Primary|Overall Objective Response|Determine the overall objective response|1.5 years||||participants|||Number
2790650|NCT00589693|Secondary|28-day All-cause Mortality Rate|Number of deaths which occured up to 28 days of the study period due to all causes|Up to 28 days|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
2790651|NCT00589693|Secondary|Number of Patients Who Had Emergence of P. Aeruginosa Resistance|Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline|Up to 6 weeks|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
2790652|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
2790653|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
2790654|NCT00589693|Primary|Clinical Cure Rate at the End-of-treatment (EOT) Visit|The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.|||Participants|||Number
2790655|NCT00589667|Secondary|Median Overall Survival|To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.|2 years|There were 25 assessable patients as described in the protocol.|||months||Full Range|Median
2790656|NCT00589667|Primary|Overall Objective Response|"To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|All assessable patients as indicated in the protocol.|||participants|||Number
2790657|NCT00589628|Primary|Effects of Infliximab on Uveitis Disease Activity.|Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.|9 months|1 subject lost to follow up|||participants|||Number
2790658|NCT00589602|Secondary|Number of Participants With Relapse-free Survival|number of patients that were still alive and relapse free|after 7 years of follow up|All patients that received treatment|||participants|||Number
2790659|NCT00589602|Secondary|Number of Participants Able to Receive T-cell Add Backs|Patients receive defined doses of donor T cells by IV infusion on days 45 and 100, in absence of active graft-versus-host disease (GVHD) requiring steroids.|through D+100||||participants|||Number
2790660|NCT00589602|Secondary|Number of Participants With Duration of Absolute Neutropenia||D+100 from transplant||||participants|||Number
2790661|NCT00589602|Secondary|The Rate of Acute Graft Versus Host Disease (GVHD)||D+100 from transplant||||participants|||Number
2790662|NCT00589602|Primary|Treatment-related Mortality (TRM)|The complication rate in matched unrelated donor (MUD) allogeneic bone marrow transplant (allo BMT) is known to be high. Graft failure and severe graft versus host disease (GvHD) are the most significant contributors to treatment related mortality (TRM). This treatment regimen will be considered unacceptable if the number of patients that experience TRM is 55% or greater, and effective if TRM is 33% or less.|180 days after transplant|Patients that received treatment|||participants|||Number
2790663|NCT00589563|Secondary|Incidence of Disease Relapse/Progression at 2 Years Post HSCT|Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.|2 year point estimate was provided.||||Percentage of patients who relapsed||95% Confidence Interval|Number
2790664|NCT00589563|Primary|Severity of Chronic GVHD|All Patients were considered for the evaluation of chronic GVHD severity.|Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT||||participants|||Number
2790665|NCT00589563|Primary|Cumulative Incidence of Chronic GVHD|Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.|2 year point estimate was provided.||||Percentage of patients developing cGVHD||95% Confidence Interval|Number
2790666|NCT00589563|Secondary|Event Free Survival at Two Years Post HSCT|Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.|2 year point estimate was provided.||||Percentage of patients with an event||95% Confidence Interval|Number
2790667|NCT00589563|Secondary|Overall Survival at Two Years Post HSCT|Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.|2 year point estimate was provided.||||Percentage of patients who died||95% Confidence Interval|Number
2790668|NCT00589563|Secondary|Non-relapse Mortality at Two Years Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|2 year point estimate was provided.||||Percentage of patients with a NRM||95% Confidence Interval|Number
2790669|NCT00589563|Secondary|Non-relapse Mortality at 100 Days Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|100 day point estimate was provided||||Percentage of patients with a NRM||95% Confidence Interval|Number
2790670|NCT00589563|Secondary|Occurence of Sinusoidal Obstructive Syndrome (SOS)|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.|Median Follow Up: 28 Months (Range: 1-49 Months)||||participants|||Number
2790671|NCT00589563|Secondary|Occurrence of Thrombotic Microangiopathy|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.|Median Follow Up: 28 Months (Range: 1-49 months)||||participants|||Number
2790672|NCT00589563|Secondary|Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation|Participants were monitored throughout the trial (median of 28 months) for various infections/complications.|Median Follow Up: 28 months (Range: 1-49 months)||||participants|||Number
2790673|NCT00589563|Secondary|Time to Platelet Count Recovery (Engraftment)|Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days.|Patients were evaluated until platelet recovery, a median of 14 days|27 of the 32 patients had platelet recovery.|||Days||Full Range|Median
2790674|NCT00589563|Secondary|Time to Absolute Neutrophil Count Recovery (Engraftment)|Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days|Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT|28 of the 32 patients had absolute neutrophil count recovery.|||Days||Full Range|Median
2790675|NCT00589563|Primary|Severity of Acute GVHD|All patients were considered for the evaluation of the severity of acute GVHD.|100 Days Post HSCT||||participants|||Number
2790676|NCT00589563|Primary|Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100|Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.|100 Days Post Hematopoietic Stem Cell Transplant (HSCT)||||Percentage of patients developing aGVHD||95% Confidence Interval|Number
2790677|NCT00589550|Secondary|Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood||Up to 1 year|||||||
2790678|NCT00589550|Secondary|Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome||up to 1 year|||||||
2790679|NCT00589550|Secondary|Overall Survival||up to 1 year|||||||
2790680|NCT00589550|Secondary|Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year|||||||
2790681|NCT00589550|Secondary|Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year|||||||
2790682|NCT00589550|Primary|Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.||up to 2 months|||||||
2790683|NCT00589550|Primary|Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate||up to 2 months|||||||
2790684|NCT00589472|Other Pre-specified|Levels of DHEA-S in Prostate Tissue||Up to 1 year|||||||
2790685|NCT00589472|Other Pre-specified|Levels of DHEA in Prostate Tissue||Up to 1 year|||||||
2790686|NCT00589472|Other Pre-specified|Levels of Androstenedione in Prostate Tissue||Up to 1 year|||||||
2790687|NCT00589472|Other Pre-specified|Levels of Androstenediol in Prostate Tissue||Up to 1 year|||||||
2790688|NCT00589472|Other Pre-specified|Levels of DHT in Prostate Tissue||Up to 1 year|||||||
2790689|NCT00589472|Other Pre-specified|Levels of Testosterone in Prostate Tissue||Up to 1 year|||||||
2790690|NCT00589472|Other Pre-specified|Gene Microarray Analysis||Up to 1 year|||||||
2790691|NCT00589472|Other Pre-specified|Gene Expression Analysis, Including AR Target Genes, PSA and TMPRSS2|Estimates and 95% confidence intervals for the proportion of patients with nondetectable levels of PSA and TMPRSS2 will be computed.|at 12 weeks|||||||
2790692|NCT00589472|Other Pre-specified|Safety and Tolerability of Androgen Depletion Therapy in Combination With Vorinostat as Assessed by Physical Examinations, Adverse Events, and Laboratory Assessments. Please See Adverse Events Section.|Adverse events will be monitored at each scheduled visit and throughout the study. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 1 year|||||||
2790693|NCT00589472|Other Pre-specified|Protein Expression Analysis, Including AR Target Genes, PSA and TMPRSS2||Up to 1 year|||||||
2790694|NCT00589472|Secondary|Levels of Testosterone in Blood From Radical Prostatectomy Specimens||Up to 1 year||||ng/dL||95% Confidence Interval|Median
2790699|NCT00589472|Secondary|Gleason Score|A Gleason score is the sum of two numbers. Pathologist determines where the cancer is most prominent and assigns the primary grade, the secondary grade is assigned based on where the cancer is next most prominent. A score from one to five is assigned for each area based on how aggressive the tumor appears. A tumor with cell that appear close to normal is assigned a low Gleason score (six or below). A tumor with cells that appear clearly different from those of a normal prostate is assigned a high Gleason score (seven or above). A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.|Baseline||||units on a scale||95% Confidence Interval|Median
2790700|NCT00589472|Primary|Pathologic Complete Response at the Time of Surgery|The primary endpoint will be pathologic complete response at the time of surgery. This represents the proportion of patients with no evidence of disease in the prostate (ie, the absence of tumor in the posttherapy pathology specimen) at the time of radical prostatectomy. Pathologic complete response at the time of surgery is the primary endpoint for this study. A Simon 2-stage optimal design that differentiates between response probabilities of 0.05 and 0.20 will be used in the analysis of the pathological complete response at 12 weeks (Type I error 10% and power 90%). A maximum of 38 pts were planned for accrual onto this study. If zero or one response was observed, then the trial was to be stopped. The design had power 0.90 for a population response proportion to 0.20 using a one-sided 0.10 size test. pT2 indicates that the cancer is confined to the prostate, while pT3 indicates that there is an extraprostatic extension of the cancer.|At 12 weeks||||Participants|||Count of Participants
2790701|NCT00589329|Secondary|Respiratory Distress|Respiratory distress will be defined by the clinical record documentation of the neonatal team.|newborn nursery||||Participants|||Count of Participants
2790702|NCT00589329|Primary|Length of Pregnancy Prolongation|The length of time (in hours) from initiation of therapy to delivery will establish the latency|Measured from randomization to delivery in hours||||hours||Full Range|Mean
2790703|NCT00589303|Primary|Cardiac Hospitalization Within Six Months of Enrollment|Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.|Six months after enrollment|Intent-to-treat|||participants|||Number
2790704|NCT00589290|Primary|Chromosomal Gains or Losses in Comparative Genomic Hydridization in Thymoma and Thymic Cancer|Utilize a patients tumor tissue to determine if there is any correlation between chromosomal gains or losses in comparative genomic hybridization in thymoma and thymic carcinomas and clinical outcomes.|46 months|Unpublished data from Dr. Giaccone's lab does not reveal an association between these parameters and outcomes in patients with thymic malignancies. Hence we do not plan to perform analyses for these outcome measures and there is no known negative clinical implications associated with this.||||||
2790705|NCT00589290|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|26 months||||Participants|||Number
2790706|NCT00589290|Primary|Number of Participants With a Partial Response|Response is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.|25.5 months||||Participants|||Number
2790707|NCT00589277|Secondary|7 Day Abstinence|The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.|3 month follow up|Per protocol|||participants|||Number
2790708|NCT00589277|Secondary|24 Hour Abstinence|The number of survey respondents that had abstained from smoking at the 2 week follow up.|2 week follow up|Per protocol|||participants|||Number
2790709|NCT00589277|Primary|Quit Attempt|Percentage of those that self reported attempting to quit smoking at the 2 week follow up.|2 week follow up|Per protocol|||participants|||Number
2790710|NCT00589121|Other Pre-specified|Comparison of SAQ Scores at 2 Years for Cohort A Patients With Cohort B Patients||2 years after start of treatment (+/- 3 months)|||||||
2790711|NCT00589121|Other Pre-specified|Comparison of TESS and the MSTS Scores at 2 Years Between Cohort B Patients and the Preoperative Radiotherapy Patients in the NCIC CTG Trial [National Cancer Institute of Canada Clinical Trials Group]||2 years after start of treatment (+/- 3 months)|||||||
2790712|NCT00589121|Other Pre-specified|Correlation of Late Radiation Morbidity at 2 Years With the 3 Quality of Life Assessments [Functional Assessment of Cancer Therapy-General (FACTG), Toronto Extremity Salvage Score (TESS), and Sexual Adjustment Questionnaire (SAQ)]||2 years after start of treatment (+/- 3 months)|||||||
2790713|NCT00589121|Secondary|Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of patients||95% Confidence Interval|Number
2790714|NCT00589121|Secondary|Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years|"The Musculoskeletal Tumor Rating Scale (MSTS) is a measure of physical function across 7 items, completed by the physician (preferably by the Orthopedic Surgeon or Surgical Oncologist) or the physician's designated staff. The 7 items are: pain, range of motion, strength, joint stability, joint deformity, emotional, acceptance, and overall function. Each item is scored from 0-5 (worst possible to best possible condition). The item scores are summed to get the total score which ranges from 0-35.~Late radiation morbidity is defined as ≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE."|From start of treatment to 2 years.|All eligible patients on Cohort B who had a 2-year MSTS assessment. (See limitations and caveats, Cohort A is not included.)|||units on a scale||Standard Deviation|Mean
2790715|NCT00589121|Secondary|Pattern of First Failure|Pattern of first failure including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.|From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. All eligible patients on Cohort B. (See limitations and caveats, Cohort A is not included.)|||participants|||Number
2790716|NCT00589121|Secondary|Percentage of Patients With Wound Complications|Estimate rate of patients with acute wound complications with 95% confidence interval assuming binomial distribution.|From date of surgery to 4 months post-surgery|All eligible patients on cohort B that had surgery and a wound assessment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790717|NCT00589121|Secondary|Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|2 years after start of treatment (+/- 3 months)|All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790718|NCT00589121|Secondary|Second Primary Tumor Rate at Two Years|Second primary tumor is defined as the time from registration to date of failure (second primary tumor) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790719|NCT00589121|Secondary|Overall Survival Rate at Two Years|Overall survival is defined as the time from registration to date of death or last follow-up. Two year survival rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790720|NCT00589121|Secondary|Disease-free Survival Rate at Two Years|Disease-free survival is defined as the time from registration to date of failure (local, regional, or distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790721|NCT00589121|Secondary|Distant Disease-free Survival Rate at Two Years|Distant disease-free survival is defined as the time from registration to date of failure (distant progression or death) or last follow-up. Two year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790722|NCT00589121|Secondary|Distant Failure Rate at Two Years|Distant failure is defined as the time from registration to date of failure (distant progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790723|NCT00589121|Secondary|Regional Failure Rate at Two Years|Regional failure is defined as the time from registration to date of failure (regional progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790724|NCT00589121|Secondary|Local Failure Rate at Two Years|Local failure is defined as the time from registration to date of failure (local progression) or death or last follow-up. Two year rate and 95% confidence interval were estimated by the cumulative incidence method.|From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.|All eligible patients on Cohort B who started study treatment. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790725|NCT00589121|Primary|Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria|The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.|2 years after start of treatment (+/- 3 months)|All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)|||percentage of participants||95% Confidence Interval|Number
2790726|NCT00589108|Secondary|Percentage of Knees Surviving at 5 Years|Kaplan-Meier analysis of five-year implant survival rate|5 years post-surgery||||percentage of knees|||Number
2790760|NCT00588809|Secondary|Proportion of Subjects With KRAS Mutation|Proportion of subjects with KRAS mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.|||percentage of participants|||Number
2790727|NCT00589108|Secondary|Knee Society Stair Climbing Score|The stair-climbing portion of the Knee Society clinical rating system assigns a maximum score of 50 points for patients able to ascend and descend stairs in a normal fashion, 40 points for patients needing a rail to descend, 30 points for patients using a rail in both directions, 15 points for patients able to ascend but not descend at all, and 0 points for patients unable ascend or descend. Because stair ascent and descent put substantial demands on the patellofemoral joint, we used that portion of the Knee Society clinical rating system as a proxy for patellofemoral function in this study.|two years post-surgery, five years post-surgery||||units on a scale||Full Range|Mean
2790728|NCT00589108|Secondary|Knee Society Pain Score|The Knee Society Pain Score includes walking and climbing stairs. The maximum score per knee is 50 indicating no pain, and 0 indicates severe pain. Therefore the total score (for both knees) could range from 0 to 100.|5 years post-surgery||||units on a scale||Standard Deviation|Mean
2790729|NCT00589108|Secondary|Knee Society Function Score|The Knee Society Function Score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. The minimum function score is 0.|5 years post surgery||||units on a scale||Standard Deviation|Mean
2790730|NCT00589108|Primary|Maximum Knee Flexion|The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.|2 years post-surgery, 5 years post-surgery||||degrees||Full Range|Mean
2790731|NCT00589056|Secondary|Clinical Response of Tumor|Tumor size as determined by imaging|90 days||||percentage of participants||95% Confidence Interval|Number
2790732|NCT00589056|Primary|Maximum Tolerated Dose of Nelfinavir|As determined by dose escalation rules|90 days||||mg PO twice daily|||Number
2790733|NCT00589056|Primary|Dose-limiting Toxicity|Any grade III or higher toxicity during chemoradiation, per CTCAE|90 days||||Dose-limiting toxicities|||Number
2790734|NCT00588965|Secondary|Tpeak-end Interval (Tpe)|Tpeak-end interval was measured at rest, exercise, and recovery on placebo and on propranolol.|Measured after 2 weeks on each intervention||||ms||Standard Deviation|Mean
2790735|NCT00588965|Primary|QTc Response to Exercise on Versus Off Beta-blocker.|To minimize the effect of heart rate on QT, QT was measured at heart rates between 100 and 110 beats per minute during exercise (on and off beta-blocker) and during recovery (on and off beta-blocker).|2 weeks on each treatment then exercise test|Please note that this was a crossover study. There were 35 subjects and each subject completed both the placebo and beta-blocker arm.|||ms||Standard Deviation|Mean
2790736|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|80 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790737|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790738|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790739|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation|Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol|Baseline|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790740|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|80 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790741|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|45 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790742|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|15 minutes|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790743|NCT00588952|Primary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation|Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|All available data was utilized in the analysis using mixed models|||units on a scale||Standard Deviation|Mean
2790744|NCT00588900|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 2 years|Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.||||||
2790745|NCT00588900|Secondary|Radiographic Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Up to 2 years|Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.||||||
2790746|NCT00588900|Primary|The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy|The 12 week progression-free rate was defined as the percentage of patients that were alive and progression-free 12 weeks after start of second-line therapy. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions.|at 12 weeks||||percentage of participants|||Number
2790747|NCT00588861|Primary|Harris Hip Score|"The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor."|10 Years Post-Operative|This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.||||||
2790748|NCT00588861|Secondary|Harris Hip Score Pain|"Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered None/Ignores. 40 is considered Slight/Occasional. 30 is considered Mild. 20 is considered Moderate. 10 is considered Marked. 0 is considered Totally Disabled."|Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year|This population represents patients that returned for follow-up per protocol.|||Mean Hip Pain||Standard Deviation|Mean
2790749|NCT00588848|Secondary|Cardiopulmonary Complications|Predefined cardiopulmonary complications: Myocardial Infarction, Arrhythmia, new onset Heart Failure, Stroke|72 hours|None in either group|||Participants|||Count of Participants
2790750|NCT00588848|Secondary|Apnea-Hypopnea Index (AHI)|Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe|On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep. Study was terminated early due to enrollment problems.|||events per hour||Full Range|Mean
2790751|NCT00588848|Primary|Sleep Related Hypoxemia||On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep.|||Percentage of time < 90% saturation||Full Range|Mean
2790752|NCT00588822|Secondary|Percentage of Subjects With > 50% Reduction of Monoclonal Protein Titer at 6 Months|Monoclonal immunoglobulins measured included Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM).|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
2790753|NCT00588822|Secondary|Percentage of Subjects Having One or More Stable Hand Grip Strength Ergometry Values for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving stable hand grip strength dynamometry values (no more than 10% better or worse relative to baseline at the 6 month visit on either side).|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
2790754|NCT00588822|Secondary|Percentage of Patients Having Improvement in the Hand Grip Strength Ergometry Value for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving improvement in hand grip strength dynamometry values (>10% better relative to baseline at the 6 month visit on either side).|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
2790755|NCT00588822|Secondary|Percentage of Subjects With at Least 1 Grade Improvement in the Modified Rankin Score at 6 Months|The Modified Rankin Scale was used to determine functional disability as follows: 0 = asymptomatic; 1 = symptoms not interfering with manual activities/walking normally; 2 = minor difficulties in manual activities/walking independently without support; 3 = unable to perform some manual activities/walking independently with support; 4 = unable to eat, dress or wash independently/needing assistance to walk; 5 = no useful tasks performed with upper limbs/confined to wheelchair. Therefore, scores could range from 0 to 5, with higher values indicating greater disability.|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
2790756|NCT00588822|Secondary|Percentage of Subjects Whose Disease Has Stabilized or Responded, for Either Side of the Body, as Measured by NIS at 6 Months|"The Neuropathy Impairment Score (previously called the Neurologic Disability Score [NDS]) is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist's judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.~The NIS score was measured on both sides of the body, the worst score recorded reported as 1 for each individual subject. Stability was defined as change of less than 10 points in the NIS total score. Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months||||percentage of subjects||95% Confidence Interval|Number
2790757|NCT00588822|Primary|Percentage of Subjects With at Least 10 Points Improvement in the Neuropathy Impairment Score (NIS) for Either Side of the Body at 6 Months|"The Neuropathy Impairment Score [previously called the Neurologic Disability Score (NDS)] is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist's judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.~The neurologist measured the NIS score on both sides of the body, but recorded worst score and reported as 1 for each individual subject (i.e., each subject had only 1 reported score.)~Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months|A dichotomous measure was used so that subjects who discontinued participation prematurely could be included as non-responders.|||percentage of subjects||95% Confidence Interval|Number
2790758|NCT00588809|Secondary|Proportion of Subjects With KIT Mutation|Proportion of subjects with KIT mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.|||percentage of participants|||Number
2790759|NCT00588809|Secondary|Proportion of Subjects With FLT3 ITD Mutation|Proportion of subjects with FLT3 ITD mutation|baseline (0 weeks)|FLT3 ITD mutation status was not available for one patient.|||percentage of participants|||Number
2790761|NCT00588809|Secondary|Proportion of Subjects With NRAS Mutation|Proportion of Subjects With NRAS Mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.|||percentage of participants|||Number
2790762|NCT00588809|Secondary|Proportion of Subjects With Baseline p-ERK Activation|Proportion of subjects with baseline p-ERK activation|baseline (0 weeks)|The analysis includes the 20 patients with samples available for analysis.|||percentage of participants|||Number
2790763|NCT00588809|Primary|Response Rate for Subjects Without FLT3 ITD Mutation|"Responses were defined using standard criteria developed by an International Working Group.~[Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642-9.]~In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR)."|Up to 52 weeks|Analysis only includes subjects without FLT3 ITD mutation.|||percentage of participants|||Number
2790764|NCT00588770|Other Pre-specified|To Collect Tumor Tissue Samples Available at Baseline From Prior Diagnostic Procedures for Future Correlative Studies|These were blood and tissue samples collections and have no data to report.|Baseline|||||||
2790765|NCT00588770|Other Pre-specified|To Collect Blood Samples Before and After Therapy for Future Correlative Studies|These were blood and tissue samples collections and have no data to report.|Before and after therapy|||||||
2790766|NCT00588770|Secondary|Overall Response Rate|Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).|on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2790767|NCT00588770|Secondary|Progression-free Survival (PFS)|Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method.|on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks|All randomized patients|||months||95% Confidence Interval|Median
2790768|NCT00588770|Primary|Overall Survival (OS)|Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.|assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry|All randomized patients|||months||95% Confidence Interval|Median
2790769|NCT00588731|Secondary|Overall Cognition as Measured on the MATRICS Battery|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample.|6 weeks||||t-score||Standard Deviation|Mean
2790770|NCT00588731|Primary|Verbal Short Term Memory|Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50.|6 weeks||||t-score||Standard Deviation|Mean
2790771|NCT00588692|Secondary|Change in Arterial Elastance|Elastance is a measure of the tendency of a hollow organ to recoil toward its original dimensions upon removal of a distending or compressing force. Effective arterial elastance was determined by the ratio of end systolic BP/stroke volume (SV).|baseline, 6 months||||mmHg/ml||Standard Deviation|Mean
2790772|NCT00588692|Secondary|Change in Augmentation Index|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.~Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months||||percentage of change in AIx||Standard Deviation|Mean
2790773|NCT00588692|Secondary|Change in Central Diastolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months||||mmHg||Standard Deviation|Mean
2790774|NCT00588692|Secondary|Change in Central Systolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months||||mmHg||Standard Deviation|Mean
2790775|NCT00588692|Secondary|Change in Brachial Diastolic BP|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.~There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)~Brachial diastolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months||||mmHg||Standard Deviation|Mean
2790776|NCT00588692|Secondary|Change in Brachial Systolic Blood Pressure (BP)|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.~There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)~Brachial systolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months||||mmHg||Standard Deviation|Mean
2790777|NCT00588692|Secondary|Change in Mitral E Wave Deceleration Time|The deceleration time (DT) is the time taken from the maximum E point to baseline. Normally in adults it is less than 220 milliseconds. The DT was measured by pulse wave doppler.|baseline, 6 months||||milliseconds (ms)||Standard Deviation|Mean
2790778|NCT00588692|Secondary|Change in Mitral E/A Ratio|The E/A ratio is a marker of the function of the left ventricle of the heart; it is determined by echocardiography, an ultrasound-based cardiac imaging modality. Abnormalities in the E/A ratio on Doppler echocardiography suggest that the left ventricle, which pumps blood into the circulation, cannot fill with blood properly in the period between contractions. The E/A ratio is the ratio of peak early transmitral inflow velocity and peak late mitral inflow velocity.|baseline, 6 months||||ratio||Standard Deviation|Mean
2790779|NCT00588692|Secondary|Change in Mitral E Velocity|The Mitral E velocity is the speed at which blood fills the ventricle. It is determined by echocardiography, an ultrasound-based cardiac imaging modality.|baseline, 6 months||||cm/sec||Standard Deviation|Mean
2790780|NCT00588692|Secondary|Change in Stroke Volume|Stroke volume (SV) is the volume of blood pumped from one ventricle of the heart with each beat. SV was determined from pulse wave (PW) and continuous wave (CW) Doppler in the LV outflow tract.|baseline, 6 months||||ml||Standard Deviation|Mean
2790781|NCT00588692|Secondary|Change in LV Ejection Fraction|"The ejection fraction is the percentage of the volume in the left ventricle ejected during a cardiac cycle. The normal ejection fraction is 55 to 75 percent. EF = (EDV ‑ ESV) / EDV where EF = ejection fraction, EDV = volume of blood in the left ventricle at end‑diastole, ESV = volume of blood in the left ventricle at end‑systole.~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7)."|baseline, 6 months||||percentage of LV blood volume||Standard Deviation|Mean
2790782|NCT00588692|Secondary|Change in LV End Systolic Volume|"End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle. End systolic volume can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV end systolic volumes was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with EF."|baseline, 6 months||||ml||Standard Deviation|Mean
2790783|NCT00588692|Secondary|Change in Left Ventricle (LV) End Diastolic Volume|"End-diastolic volume (EDV) is the volume of blood in the right and/or left ventricle at end load or filling in (diastole). An increase in EDV increases the preload on the heart and, through the Frank-Starling mechanism of the heart, increases the amount of blood ejected from the ventricle during systole (stroke volume).~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV EDV was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with ejection fraction (EF)."|baseline, 6 months||||ml||Standard Deviation|Mean
2790784|NCT00588692|Secondary|Change in Heart Rate||baseline, six months||||bpm||Standard Deviation|Mean
2790785|NCT00588692|Primary|Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.~Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months||||percentage of change in AIx||Standard Deviation|Mean
2790786|NCT00588692|Primary|Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups|Peak oxygen uptake (VO2) is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. Maximal oxygen consumption reflects the aerobic physical fitness of the individual. VO2 data was obtained via standard breath-by-breath expired gas analysis. Ejection Fraction Subgroups are based on participants reported at baseline.|baseline, 6 months|For the EF subgroup 25-49%, n=48, 24 SphygmoCor Unblinded, 24 SphygmoCor Blinded. For the EF subgroup 35-49%, n=33, 14 SphygmoCor Unblinded,. 19 SphygmoCor Blinded. 2 subjects had EF either <25 or >50, and they were not included in the analysis.|||percentage of change in Peak VO2||Standard Deviation|Mean
2790788|NCT00588666|Primary|Evaluate the Time to Disease Progression|Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI, 92(3):205-216, 2000]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria.|3 years||||months||95% Confidence Interval|Median
2790789|NCT00588640|Primary|Number Who Reached a Safe Dose|The number of patients who reached a safe and well tolerated dose of d-methadone|2 years||||participants|||Number
2790790|NCT00588536|Primary|Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.||Conclusion of the study||||participants|||Number
2790791|NCT00588471|Secondary|Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI|"The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy.~The results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.||||||
2790792|NCT00588471|Primary|Change in Serum High Sensitivity C-Reactive Protein (hsCRP)|"The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows:~Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L"|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.||||||
2790793|NCT00588445|Secondary|Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data|Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array.|2 years||||percentage of participants|||Number
2790794|NCT00588445|Primary|The Radiographic Response to Gefitinib|Radiographic response is defined as a minor response ( > 25% decrease in the sum of the products of measured lesions)|21 days||||participants|||Number
2790795|NCT00588406|Secondary|Hospitalization||6 hours||||percentage of participants|||Number
2790796|NCT00588406|Primary|FEV1 Percent Predicted||4 hours post-randomization||||percent predicted of FEV1||Standard Deviation|Mean
2790797|NCT00588380|Secondary|Insulin Secretion at 210-240 Minutes|The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.|210 - 240 minutes after GLP-1 infusion|All participants completing the study.|||10^-9 min^-1||Standard Error|Mean
2790798|NCT00588380|Primary|Insulin Secretion at 150-180 Minutes.|The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.|150 - 180 minutes after GLP-1 infusion|all participants completed the study|||10^-9 min^-1||Standard Error|Mean
2790799|NCT00588354|Secondary|Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|4 weeks||||Units on a scale||Standard Deviation|Mean
2790800|NCT00588354|Secondary|Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|2 weeks||||Units on a scale||Standard Deviation|Mean
2790801|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|4 weeks||||Units on a scale||Standard Deviation|Mean
2790802|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|2 weeks|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
2790842|NCT00587860|Secondary|Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy|"Participants who reported yes or no to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy."|Last 4 weeks of therapy||||Percentage of Participants|||Number
2790803|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|4 weeks||||Units on a scale||Standard Deviation|Mean
2790804|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|2 weeks||||Units on a scale||Standard Deviation|Mean
2790805|NCT00588354|Secondary|Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|2 weeks|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
2790806|NCT00588354|Primary|Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|4 weeks|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
2790807|NCT00588341|Primary|Overall Objective Response (Complete Response or Partial Response)|"The Response Evaluation Criteria in Solid Tumors (RECIST) will be used to determine treatment response.~Clinical Complete Response (CRc) Disappearance of all target lesions and non-measurable disease.~Pathological Complete Response (CRp) A CRc in which a lymph node dissection done after completing temozolomide treatment shows no pathological evidence of melanoma. Partial Response (PR) A greater or equal then 30% in the sum of the longest diameter of all target lesions relative to baseline measurement"|2 years||||participants|||Number
2790808|NCT00588237|Primary|Overall Objective Response|as determined by the GOG RECIST criteria|2 years||||participants|||Number
2790809|NCT00588159|Secondary|Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively|Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively|48 hours postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).|||mg||Standard Deviation|Mean
2790810|NCT00588159|Primary|Average Pain Score With Coughing on Second Morning After Surgery|Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.|Second morning after surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy.Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).|||Unites on a scale||Standard Deviation|Mean
2790811|NCT00588159|Primary|Average Pain Score With Coughing the First Morning Following Surgery|Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.|First morning following surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).|||Units on a scale||Standard Deviation|Mean
2790812|NCT00588159|Secondary|Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively|Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.|3 months postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Patients who rated their average pain 1 or greater were included.|||Participants|||Number
2790813|NCT00588159|Secondary|Opioid Consumption in First 24 Hours Postoperatively||24 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).|||mg||Standard Deviation|Mean
2790814|NCT00588159|Primary|Average Pain Score at Rest|Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.|48 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).|||Units on a scale||Standard Deviation|Mean
2790815|NCT00588146|Primary|Change in Hemoglobin|The hemoglobin level is expressed as the amount of hemoglobin in grams (gm) per deciliter (dL) of whole blood.|baseline, one year|Only 3 subjects completed the study, so the numbers were too low to analyze the study.||||||
2790816|NCT00588094|Primary|Improve the Overall Response Rate|assessing the response rate (CR+PR)|2 years||||participants|||Number
2790817|NCT00587990|Secondary|Number of Abnormal Echocardiogram Readings 2 Days Post CABG.|The number of abnormal Echocardiogram readings 2 Days Post CABG will be documented based on transthoracic Echocardiographic standards. However, although Echocardiograms 2 days post CABG operation may show abnormalities which is standard in this population, this testing is instrumental because it measures End- diastolic wall thickness and Left ventricular volumes at end-diastole and end-systole.|Day 2|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine dose groups to make a comparison to placebo subjects.|||Abnormal Echocardiograms|||Number
2790818|NCT00587990|Secondary|Rate of Treatment Emergent Adverse Events|Rate of Treatment Emergent Adverse Events Post Coronary Artery Bypass Graft (CABG) at 6 Months, 12 Months, and 18 Months|Assessed at 6 Months, 12 Months, and 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.|||Number of Adverse Events||95% Confidence Interval|Mean
2790819|NCT00587990|Secondary|Number of Clinically Significant Laboratory Values|Clinically significant laboratory values are first determined via standard laboratory normal values from a CAP and CLIA certified Laboratory and then assessed by investigator based on specific patient conditions and disease state.|18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||Incidents|||Number
2790820|NCT00587990|Secondary|Creatinine Kinase - Muscle/Brain (MB) (ng/mL)|Creatinine Kinase MB (ng/mL) Values every 12 hours from Baseline to 48 Hours Post CABG|Assessed at Baseline, 12 Hours, 24 Hours, 36 Hours, and 48 hours post CABG|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.|||ng/mL||95% Confidence Interval|Median
2790821|NCT00587990|Secondary|Serial Troponin Values (ng/mL)|Serial Troponin Values (ng/mL) Values from Baseline to 48 Hours Post CABG|Assessed at Baseline, 12 hours, 24 hours, 36 hours, and 48 hours post CABG|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.|||ng/mL||95% Confidence Interval|Median
2790822|NCT00587990|Secondary|Change in Pulmonary Function|Change in Pulmonary Function from Baseline to 6 month, Baseline to 12 month, and Baseline to 18 month visits as measured by forced expiratory volume in 1 second (FEV1)|Baseline, 6 Months, 12 Months, 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||Liters||95% Confidence Interval|Mean
2790823|NCT00587990|Secondary|Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings|"Ambulatory ECG monitoring is the most widely employed technology for the evaluation of a patient with symptoms suggestive of cardiac arrhythmia or conduction abnormality.~When the patient returns for follow up the 48- Hour Ambulatory monitor provides the data to the site staff to detect any abnormal recordings based upon standard ECG protocol."|Assessed at 6 Months, 12 Months, and 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||Participants|||Count of Participants
2790824|NCT00587990|Secondary|Incidence of Major Adverse Cardiac Events (MACE)|Incidence of Major Adverse Cardiac Events (MACE). A composite incidence of (1) death, (2) hospitalization for heart failure, or (3) non-fatal recurrent Ml.|18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.|||# of Major Adverse Cardiac Events (MACE)|||Number
2790825|NCT00587990|Secondary|Minnesota Living With Heart Failure Questionnaire Scores|Minnesota Living with Heart Failure (MLHF) questionnaire has a total score from 0 to 105. A higher score indicates that participants heart failure is preventing them from living their lives measured at two time points.|Assessed at 6 Months and 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||score on a scale||95% Confidence Interval|Mean
2790826|NCT00587990|Secondary|Change in NYHA Functional Class|"Change in New York Heart Association (NYHA) Functional Classification based on patient's self reported activity level.~Worsened: documented increase in limitations of physical activity as self-described by subject Improved: documented decrease in limitations of physical activity as self-described by subject Unchanged: no documented change in limitations of physical activity as self-described by subject"|Baseline to 6 Months, 6 months to 18 Months|Due to the early termination of the study,there was an insufficient sample size of the MSC treated participants.The statistical analysis plan was revised to combine the low and high dose groups.1 treated subject's NYHA class was not captured at the 18 Month time point.1 placebo treated subject expired prior to 6 and 18 months NYHA class assessment.|||Participants|||Count of Participants
2790827|NCT00587990|Secondary|Change in Six Minute Walk Test|Change in Six Minute Walk Test (in meters) from Baseline to 6 Months and Baseline to 18 Months|Baseline, 6 Months, 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||Meters||95% Confidence Interval|Median
2790828|NCT00587990|Secondary|Change in Peak Volume Oxygen|Change in Peak VO2 as determined by treadmill test (mL/mg/min) from Baseline to 6 and from baseline to 18 months|Baseline, 6 Months, 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||(mL/mg/min)||95% Confidence Interval|Mean
2790864|NCT00587678|Primary|Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.|Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.|2 years||||seconds||Standard Deviation|Mean
2790829|NCT00587990|Secondary|Change in Left Ventricular Ejection Fraction|Change between baseline to 6-month and 18-month left ventricular ejection fraction (LVEF) as determined by MRI and echocardiogram.|Baseline to 6 Months, Baseline to 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||percentage of Ejection Fraction||95% Confidence Interval|Mean
2790830|NCT00587990|Secondary|Change in Left Ventricular End Diastolic and Systolic Volume|Change in left ventricular end diastolic and systolic volume as determined by MRI and echocardiogram.|Baseline, 6 Months, 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.One placebo subject expired Day 3 post injection.|||ml||95% Confidence Interval|Mean
2790831|NCT00587990|Secondary|Left Ventricular End Diastolic Wall Thickness|Difference between the baseline and 18 month left ventricular end diastolic wall thickness as determined by MRI and echocardiogram.|Assessed at Baseline and 18 months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||mm||Standard Error|Mean
2790832|NCT00587990|Secondary|Regional Left Ventricular Wall Thickening|Difference between baseline and 18 month regional left ventricular wall thickening as determined by MRI.|Assessed at Baseline and 18 months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.One placebo subject expired Day 3 post injection.|||mm||Standard Error|Mean
2790833|NCT00587990|Secondary|Left Ventricular Function (LVF) in Region of MSC Injection|The Left Ventricular Function differences in the region of MSC injection were evaluated. LVF is evaluated via ECHO as the percentage of ejected blood.|Assessed at Baseline and 18 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection.|||percentage of ejected blood||Standard Error|Mean
2790834|NCT00587990|Secondary|Change in Infarct Scar Size (ISS) Over 18 Month Period|Change in infarct scar size (ISS) between baseline and 6-month and 18 month visits as determined by delayed contrast-enhanced MRI.|Baseline, 6 Months, 18 Months|One placebo subject expired Day 3 post injection. Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.|||Grams (g)||95% Confidence Interval|Mean
2790835|NCT00587990|Primary|Number of Patients With Serious Adverse Events|Six-month post-CABG surgery serious adverse event (SAE) proportion of patients experiencing a composite of sustained ventricular arrhythmias, (lasting longer than 15 seconds), with hemodynamic compromise, sudden unexpected death at six months, ectopic tissue formation at 12 months by chest/abdomen/pelvis CT exam.|12 Months|Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.|||Participants|||Count of Participants
2790836|NCT00587964|Primary|Local Control|"following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI.~No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease."|1 year||||participants|||Number
2790837|NCT00587860|Secondary|Bowel Symptom Score (BSS) at 24 Weeks|The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.|24 weeks||||Units on a scale||Full Range|Median
2790838|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|24 weeks||||Units on a scale||Full Range|Median
2790839|NCT00587860|Secondary|IBS Symptoms Moderately or a Lot Better|Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.|24 weeks||||participants|||Number
2790840|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|12 weeks||||Units on a scale||Full Range|Median
2790841|NCT00587860|Secondary|Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.|12 weeks of treatment||||Units on a scale||Full Range|Median
2790843|NCT00587860|Secondary|Bowel Symptom Score (BSS) Amongst Subgroups|Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.|12 weeks|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.|||Scores on a scale||Full Range|Median
2790844|NCT00587860|Primary|Overall Bowel Symptom Scores (BSS)|"The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).~The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain."|After 12 weeks of treatment|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.|||Scores on a scale||Full Range|Median
2790845|NCT00587847|Secondary|Rate of Infections|Number of participants who developed clinical or laboratory evidence of infection.|Weekly then every 2 weeks then every 3 weeks|All participants who received at least one dose of alemtuzumab were analyzed for safety.|||participants|||Number
2790846|NCT00587847|Primary|Time to Progression (Months)|Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.|Every 8 weeks|All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.|||months||Full Range|Mean
2790847|NCT00587834|Secondary|Pain Absent After 3 Days (Superiority)|Pain Assessment(Modified Intent-to-Treat Population)|Day 3|||||||
2790848|NCT00587834|Secondary|Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)|The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.|6 months|See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy.|||Participants|||Number
2790849|NCT00587834|Secondary|Patient Preference After 6 Months/Early Termination (Superiority)|Number of patients expressing preference for Gintuit.|6 months|See description in primary outcome measure.|||participants||95% Confidence Interval|Number
2790850|NCT00587834|Secondary|Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.|6 months|See description in primary outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2790851|NCT00587834|Secondary|Texture Same as Adjacent Tissues After 6 Months (Superiority)|"An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as More Firm, Equally Firm, or Less Firm as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome."|6 months|See description in primary outcome measures.|||Participants|||Number
2790852|NCT00587834|Secondary|Color Same as Adjacent Tissues After 6 Months (Superiority)|"An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as More Red, Equally Red, or Less Red as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome."|6 months|See description in primary outcome measure.|||Participants|||Number
2790853|NCT00587834|Primary|Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.|6 months|Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes.|||percentage of participants||95% Confidence Interval|Number
2790854|NCT00587795|Primary|Change in Distal Radius Fracture at 8 Weeks|The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1-3), fair (4-6) and poor (7-12).|baseline, 8 weeks|||||||
2790855|NCT00587769|Secondary|Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|6 months||||Participants|||Number
2790856|NCT00587769|Primary|Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|12 weeks||||Participants|||Number
2790857|NCT00587678|Secondary|V02 - Maximal Oxygen Consumption||2 years||||ml/min/kg||Standard Deviation|Mean
2790858|NCT00587678|Secondary|6-minute Walk Distance||2 years||||ft.||Standard Deviation|Mean
2790859|NCT00587678|Secondary|Log Treadmill Exercise Time||2 years||||log time in seconds||Standard Deviation|Mean
2790860|NCT00587678|Secondary|Magnetic Resonance Angiographic Index|MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.|2 years||||units on scale (0 = normal, 4 = worst)||Standard Deviation|Mean
2790861|NCT00587678|Secondary|Triglycerides||2 years||||mg/dl||Standard Deviation|Mean
2790862|NCT00587678|Secondary|High Density Lipoprotein Cholesterol||2 years||||mg/dl||Standard Deviation|Mean
2790863|NCT00587678|Secondary|Total Cholesterol||2 years||||mg/dl||Standard Deviation|Mean
2790865|NCT00587678|Primary|Perfusion Index|Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.|2 years||||Units on a scale (0 = worst, 1 = best)||Standard Deviation|Mean
2790866|NCT00587678|Secondary|Low Density Lipoprotein Cholesterol||2 years||||mg/dl||Standard Deviation|Mean
2790867|NCT00587678|Primary|Plaque Volume|SFA plaque volume|2 years||||cm^3||Standard Deviation|Mean
2790868|NCT00587639|Secondary|Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)|The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).|At study visit 30||||units on a scale||Standard Deviation|Mean
2790869|NCT00587639|Primary|Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)|The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.|Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)||||units on a scale||Standard Deviation|Mean
2790870|NCT00587587|Secondary|Decreased Utilization of Intralesional Steroid Intervention|The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.|52 weeks|mITT population (randomized subjects only)|||Injections per Participant||Standard Deviation|Mean
2790871|NCT00587587|Secondary|Subject Global Assessment|Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||Participants|||Number
2790872|NCT00587587|Secondary|Physician Global Assessment|Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||Participants|||Number
2790873|NCT00587587|Secondary|Degree of Recurrence (Scar Thickness)|Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.|Week 52 or Last visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||mm||Standard Deviation|Mean
2790874|NCT00587587|Secondary|Degree of Recurrence (Scar Firmness)|Scar firmness measured by Cutometer in millimeters.|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.|||mm||Standard Deviation|Mean
2790875|NCT00587587|Secondary|Cumulative Incidence of Keloid Recurrence at Week 52|Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.|52 weeks|Cumulative assessment, mITT population for randomized subjects only|||participants|||Number
2790876|NCT00587587|Secondary|Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)|"Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.~BSS is a composite score where the individual scores from the following categories are summed:~Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).~Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar)."|Baseline to Week 52 or Last Visit|Modified ITT (mITT) for randomized subjects only. Last Visit is the score recorded at last subject visit with non-missing data.|||Units on a scale||Standard Deviation|Mean
2790877|NCT00587587|Primary|The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.|"Summary of all reported adverse events (AE) in the intent to treat (ITT) population.~AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study."|52 weeks|ITT analysis per protocol. Report of at least 1 treatment emergent AE.|||Participants|||Number
2790878|NCT00587483|Secondary|Time to Discharge From the Hospital||Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.||||Days||Standard Deviation|Mean
2790879|NCT00587483|Secondary|Time to Discharge From the Intensive Care Unit||Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.||||Days||Standard Deviation|Mean
2790880|NCT00587483|Secondary|Use of Vasopressors|Number of participants per arm who required the use of vasopressors in the post-operative period.|Participants were followed from randomization until time to discharge from the hospital.||||Participants|||Number
2790881|NCT00587483|Secondary|Incidence of Arrhythmias in the Post-Operative Period|Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.|Participants were followed from dismissal from the ICU until dismissal from the hospital.||||Participants|||Number
2790882|NCT00587483|Secondary|Incidence of Arrhythmias Other Than Ventricular Fibrillation|Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.|Participants were followed from randomization through the 60 minute period following myocardial reperfusion.||||Participants|||Number
2790883|NCT00587483|Secondary|Number of Defibrillation Attempts||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (IIT)|||Participants|||Number
2790896|NCT00587431|Primary|PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy||Conclusion of the study (at 6 months then at 18 months post-treatment)||||participants|||Number
2790884|NCT00587483|Primary|Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (ITT)|||Participants|||Number
2790885|NCT00587457|Secondary|Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression|Participants demonstrated CD22 expression on malignant cells at Screening and CD22 is a regulatory molecule that prevents the over activation of the immune system and the development of autoimmune diseases.|End of treatment (4-6 weeks after the last dose)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Percentage||Standard Deviation|Mean
2790886|NCT00587457|Secondary|Number of Participants With Positive Neutralizing Antibodies|Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.|Up to end of treatment (4-6 weeks after the last dose)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790887|NCT00587457|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively.|||nanogram per milliliter||Full Range|Median
2790888|NCT00587457|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox|The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.|Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively.|||hour||Full Range|Median
2790889|NCT00587457|Primary|Best Overall Objective Tumor Response|Antitumor activity was assessed by best overall objective tumor response.|Up to 2 years of post-treatment follow-up|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790890|NCT00587457|Primary|Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)|Objective response rate defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria.|Up to 2 years of post-treatment follow-up|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790891|NCT00587457|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790892|NCT00587457|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|AEs observed in participants with clinically significant ECG abnormalities were assessed.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790893|NCT00587457|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790894|NCT00587457|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox. Treatment-emergent were events between administration of investigational product and Day 28 that were absent before treatment or that worsened relative to pretreatment state.|From start of study drug administration until 30 days after the last dose of study drug|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Number
2790895|NCT00587431|Secondary|The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.|Docetaxel Pharmacokinetic parameters for cycles 1 and 2.|at Cycle 1 and 2|A population pharmacokinetic model was fit to the data from all individuals simultaneously using a non-linear mixed effects modeling. This was performed using NONMEM. The NONMEM model accounts for between-patient, between-course, and residual variability (random effects) as well as parameter differences predicted by covariates (fixed effects).|||L/hr||Standard Deviation|Mean
2790897|NCT00587288|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|"Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as severe. If drug relationship of an AE was missing, the AE was reported as probably related. WFT=withdrawn from treatment."|From start of study drug through 15 weeks + 30 days|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||participants|||Number
2790898|NCT00587288|Secondary|Percentage of Participants With Clinical Asthma Exacerbations (CAEs)|A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening.|up to 15 weeks|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.|||percentage of participants|||Number
2790899|NCT00587288|Secondary|Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels||End of Screening or Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||percent change in eosinophil levels||Standard Deviation|Mean
2790900|NCT00587288|Secondary|Change From Baseline to End of Therapy in Percent Predicted FEV1|The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant's percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982).|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||percent predicted FEV1||Standard Deviation|Mean
2790901|NCT00587288|Secondary|Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)|The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.|||L||Standard Deviation|Mean
2790902|NCT00587288|Secondary|Percentage of ACQ Responders at End of Therapy|Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.|||percentage of participants|||Number
2790903|NCT00587288|Primary|Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score|The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline through End of Therapy (up to 15 weeks)|Intent-to-treat (ITT) Analysis Set: all participants who received any amount of randomly assigned study drug.|||units on a scale||Standard Deviation|Mean
2790904|NCT00587223|Secondary|Proportion of Wounds Experiencing an Adverse Event||through 12 months|There was only 1 enrolled subject in the study; this endpoint was descriptively reported, no statistical analyses were performed.|||proportion of treated wounds|||Number
2790905|NCT00587223|Secondary|Reduction of Intensity of Pain||through 12 weeks|no analysis performed as only 1 subject enrolled|||change in pain intensity between groups|||Number
2790906|NCT00587223|Secondary|Recurrence of Epidermolysis Bullosa (EB) Lesions||through 12 months|no analysis performed as only 1 subject enrolled|||proportion (%) of treated wounds|||Number
2790907|NCT00587223|Secondary|Rate of Complete Wound Closure Over Time||through 12 weeks|no analysis performed as only 1 subject enrolled|||change in area from baseline to Week 12|||Number
2790908|NCT00587223|Secondary|Time Until Complete Closure||through 12 weeks|no analysis performed as only 1 subject enrolled|||days|||Number
2790909|NCT00587223|Primary|Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12||Through 12 weeks|no analysis performed as only 1 subject enrolled|||proportion (%) of treated wounds|||Number
2790910|NCT00587171|Secondary|Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|Baseline to 17 weeks||||participants|||Number
2790927|NCT00587158|Secondary|Number of Subjects Who Died or Lost Their Renal Graft During First Year|The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here.|Baseline to 1 year post kidney transplant|Per-protocol analysis.|||participants|||Number
2790911|NCT00587171|Secondary|Distribution of Randot Preschool Stereoacuity at 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 weeks||||participants|||Number
2790912|NCT00587171|Secondary|Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||letters||Standard Deviation|Mean
2790913|NCT00587171|Secondary|Mean (SD) of Intereye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||letters||Standard Deviation|Mean
2790914|NCT00587171|Secondary|Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||letters||Standard Deviation|Mean
2790915|NCT00587171|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||participants|||Number
2790916|NCT00587171|Secondary|Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||letters||Standard Deviation|Mean
2790917|NCT00587171|Secondary|Distribution of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||participants|||Number
2790918|NCT00587171|Primary|Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||letters||Standard Deviation|Mean
2790919|NCT00587171|Primary|Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks||||participants|||Number
2790920|NCT00587171|Primary|Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||letters||Standard Deviation|Mean
2790921|NCT00587171|Primary|Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||participants|||Number
2790922|NCT00587158|Secondary|Degree of Interstitial Fibrosis on Graft Biopsy at One Year|"Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed using the Banff schema; Quantitative criteria: ci0 = fibrosis observed in up to 5% of cortical area, ci1 = fibrosis in 6%-25% of cortical area (mild) , ci2 = fibrosis in 26%-50% of cortical area (moderate), ci3 = fibrosis in greater than 50% of cortical area (severe). The degree of interstital fibrosis for this study was defined and reported as follows: a Banff ci score of greater than 0 and less than 2 considered mild fibrosis and a ci score greater than or equal to 2 as moderate to severe fibrosis."|1 year post kidney transplant|Per-protocol analysis; graft biopsies were not available for all subjects|||Participants|||Number
2790923|NCT00587158|Secondary|24-hour Total Protein in the Urine at 1 Year Post Transplant|A urine total protein test is conducted to detect excess protein in the urine. This test helps determine an individual's kidney functioning. Protein is not usually present in urine; therefore, presence of protein in the urine is a sign of abnormality. The quantity of protein in a sample of urine collected over 24-hour was measured and reported in milligrams per day.|1 year post kidney transplant|Per-protocol analysis. The 24-hour urine collection was not completed for all subjects.|||mg/day||Standard Deviation|Mean
2790924|NCT00587158|Secondary|Mean Change in Estimated Glomerular Filtration Rate (eGFR) Between 3 Weeks and 1 Year Post Transplant||3 weeks, 1 year post kidney transplant|Per-protocol analysis|||mL/min/1.73 m^2||Standard Deviation|Mean
2790925|NCT00587158|Secondary|Mean Estimated Glomerular Filtration Rate (eGFR) at One Year|Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m^2 of body-surface area.|1 year post kidney transplant|Per-protocol analysis|||mL/min/1.73m^2||Standard Deviation|Mean
2790926|NCT00587158|Secondary|Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant|The number of episodes of ACR, as proven by renal biopsy, were recorded.|Baseline to 1 year post kidney transplant|Per-protocol analysis.|||episodes|||Number
2790928|NCT00587158|Secondary|Change in Hip Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis. Not all subjects were able to undergo the DEXA scan of the hip at baseline and one-year [Control n = 41/Treatment n = 40].|||T-score||Standard Deviation|Mean
2790929|NCT00587158|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis; Not all subjects were able to undergo the DEXA scan of the spine at baseline and one-year [Control n = 42/Treatment n = 41].|||T-score||Standard Deviation|Mean
2790930|NCT00587158|Secondary|Serum Bone Alkaline Phosphatase (BAP) Level Over Time|BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L).|Baseline, 21 days, 90 days and 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified study visits. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:~Baseline: 43/41, Day 21: 34/38, Day 90: 36/36, Day 365: 43/41"|||mcg/L||Full Range|Median
2790931|NCT00587158|Secondary|Serum Parathyroid Hormone (PTH) Level Over Time|Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL).|Baseline, 3 weeks, 3 months, 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified timepoints. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:~Baseline: 43/41, Day 21: 44/41, Day 90: 44/43, Day 365: 44/43"|||pg/mL||Full Range|Median
2790932|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis; Data were not available for 1 subject from each arm because these subjects did not have the one year DEXA scan of the spine. [Control n = 43/Treatment n = 42].|||Participants|||Number
2790933|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the hip made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the hip at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis. Data were not available for 2 control subjects and 2 treatment subjects, as these subjects did not have the DEXA scan of the hip done at one year. [Control n=42/ Treatment=41]|||Participants|||Number
2790934|NCT00587158|Primary|Number of Subjects With Hyperparathyroidism at One Year|Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant.|1 year post kidney transplant|Analysis was performed by the intention-to-treat principle, comprised of all subjects enrolled, who will have taken at least one dose of study medication and have both screening and any post-screening efficacy data recorded. The last observation was carried forward for missing values.|||Participants|||Number
2790935|NCT00587132|Primary|Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.|Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.|Day 1 of study|All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.|||participants|||Number
2790936|NCT00587067|Other Pre-specified|Molecular Genetic Changes Associated With These Tumors|Use comparative genomic hybridization and cDNA array from tumor and liver biopsy specimens obtained at the time of operation|5 years||2020-06-30|06/2020||||
2790937|NCT00587067|Secondary|Disease Progression||Up to 5 years||||Participants|||Count of Participants
2790938|NCT00587067|Primary|Number of Patients With Treatment Related Toxicity|Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0|Up to 5 years||||participants|||Number
2790939|NCT00587067|Primary|Treatment Response|To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).|Up to 5 years||||Participants|||Count of Participants
2790941|NCT00587041|Secondary|24 Hour Urine Oxalate Excretion|The amount of oxalate excreted in the urine over a 24 hour period, a risk for calcium oxalate kidney stones|At end of study, approximately 6 weeks|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.|||mmol/L||Standard Deviation|Mean
2790942|NCT00587041|Primary|Change in 24-hour Urinary Supersaturation for Calcium Oxalate|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate. Values for supersaturated ions are expressed in units of Gibbs free energy.|Time zero (on diet but no drug), 6 weeks (on drug and diet)|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.|||KJoules/mol||Standard Deviation|Mean
2790943|NCT00586924|Secondary|Soluble CD22 Levels by Best Response|Soluble CD22 was collected from the participant's plasma and was performed at the NCI using an ELISA method.|Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||picogram/mL||Standard Deviation|Mean
2790944|NCT00586924|Secondary|CD22 Expression Levels From Bone Marrow by Best Response|Participants malignant cells (paraffin block biopsy specimen) were tested for CD22 expression by FACS analysis.|Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||sites per cell||Standard Deviation|Mean
2790945|NCT00586924|Secondary|CD22 Expression Levels From Peripheral Blood by Best Response|Participants malignant cells (peripheral blood) were tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.|Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||sites per cell||Standard Deviation|Mean
2790946|NCT00586924|Secondary|Number of Participants With Positive Neutralizing Antibodies and Correlation to Antitumor Activity|Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit >50% of the binding of CAT-8015 to CD22 using an ELISA-based method.|Up to end of treatment (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790947|NCT00586924|Primary|Cmax Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1|The Cmax accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1.|Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||ratio||Full Range|Median
2790948|NCT00586924|Primary|AUC Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1|The AUC accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of AUC(0-last) on the last day and the first day of a multiple dose regimen: Day 5/Day 1.|Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||ratio||Full Range|Median
2790949|NCT00586924|Primary|Terminal Phase Elimination Half Life (t1/2) of Moxetumomab Pasudotox for Cycle 1 on Day 5|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||hours||Standard Deviation|Mean
2790950|NCT00586924|Primary|Terminal Phase Elimination Half Life (t1/2) of Moxetumomab Pasudotox for Cycle 1 on Day 1|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||hours||Standard Deviation|Mean
2790977|NCT00586820|Secondary|Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI|CK-MB is a cardiac marker that can demonstrate the development of heart muscle necrosis resulting from an acute interruption of blood supply to a part of the heart. CK-MB is measured by a blood test.|immediately pre-PCI, 8 hours post-PCI, 16 hours post-PCI|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.|||percent change||Inter-Quartile Range|Median
2790951|NCT00586924|Primary|Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 5|Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).|Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||mL/kg/h||Standard Deviation|Mean
2790952|NCT00586924|Primary|Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 1|Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by area under plasma concentration-time curve from time zero to infinite time (AUC[0-infinity]).|Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||Milliliter/kilogram/hour (mL/kg/h)||Standard Deviation|Mean
2790953|NCT00586924|Primary|Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Moxetumomab Pasudotox for Cycle 1 on Day 5|The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.|Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||ng*h/mL||Standard Deviation|Mean
2790954|NCT00586924|Primary|Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Moxetumomab Pasudotox for Cycle 1 on Day 1|The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.|Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2790955|NCT00586924|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox for Cycle 1 on Day 5|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
2790956|NCT00586924|Primary|Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox for Cycle 1 on Day 1|The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2790957|NCT00586924|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 5|The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||hours||Full Range|Median
2790958|NCT00586924|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 1|The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.|Cycle 1 Day 1: pre-infusion; at 15 minutes (min) during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 hours (h) post infusion|The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||hours||Full Range|Median
2790959|NCT00586924|Primary|Progression-free Survival (PFS)|PFS was measured from the start of moxetumomab pasudotox treatment until the first documentation of disease progression/relapse or death, whichever occurred first. PFS was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||months||95% Confidence Interval|Median
2790978|NCT00586820|Primary|Average Peak Velocity (APV) Immediately Following Percutaneous Coronary Intervention (PCI)|Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.|immediately following PCI procedure|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.|||cm/s||Inter-Quartile Range|Median
2790960|NCT00586924|Primary|Time to Progression|Time to disease progression/relapse is measured from the start of moxetumomab pasudotox treatment until the first documentation of disease progression or relapse and was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||months||95% Confidence Interval|Median
2790961|NCT00586924|Primary|Duration of Objective Response|Duration of response was measured from the first documentation of objective response (OR) to the first documented non-response of SD, PD, or relapse and was only evaluated in participants who had achieved an OR (CR or PR). Duration of OR was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here, the “Overall Number of Participants Analyzed” denotes the number of participants who had achieved an OR (CR or PR) and had the first documented non-response of SD, PD, or relapse.|||months||95% Confidence Interval|Median
2790962|NCT00586924|Primary|Duration of Complete Response|Duration of CR was measured from the first documentation of CR to the first documented non-CR and was evaluated in participants who had achieved an CR. Duration of CR were summarized using Kaplan-Meier estimates (median time, 95% CI for median time).|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox. Here, the “Overall Number of Participants Analyzed” denotes the number of participants who had achieved CR and had the first documented non-CR till end of the study.|||months||95% Confidence Interval|Median
2790963|NCT00586924|Primary|Time to Objective Response|Time to OR was measured from the start of moxetumomab pasudotox treatment to the first documentation of OR and was evaluated only in participants who received any treatment of moxetumomab pasudotox and had achieved an OR (CR or PR). Objective response (OR) was defined as the participants with confirmed CR or confirmed PR according to Response Evaluation Criteria.|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox. The “Overall Number of Participants Analyzed” denotes the number of participants who had achieved an OR (CR or PR).|||months||95% Confidence Interval|Median
2790964|NCT00586924|Primary|Time to Complete Response|Time to complete response (CR) was measured from the start of moxetumomab pasudotox treatment to the first documentation of CR and was evaluated only in participants who received any treatment of moxetumomab pasudotox and had achieved a CR. Time to complete response was summarized using Kaplan-Meier estimates (median time, 95% confidence interval [CI] for median time).|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox. The “Overall Number of Participants Analyzed” denotes the number of participants who had achieved a CR.|||months||95% Confidence Interval|Median
2790965|NCT00586924|Primary|Number of Participants With Progressive Disease (PD)|Progressive disease is defined by at least one of the following compared to pretreatment:>= 25% increase in the sum of the products of the greatest perpendicular dimensions of at least two lymph nodes on two consecutive examinations at least 2 weeks apart (at least 1 node must be >= 2 cm) or appearance of new palpable lymph nodes, >=25% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, or appearance of new palpable hepatomegaly or splenomegaly that was not previously present, >=50% increase in the absolute number of circulating lymphocytes, >=25% decrease in hemoglobin (must be < 11g/dL), platelets (must be < 100,000/mcL), or absolute neutrophil count (must be < 1500/mcL) unless these are judged to be effects of treatment.|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790966|NCT00586924|Primary|Number of Participants With Stable Disease (SD)|Stable disease was characterized by not meeting the criteria for CR, PR or PD.|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790967|NCT00586924|Primary|Number of Participants With Partial Response (PR)|Partial response requires all of the following: >=50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, >=50% reduction in lymphadenopathy, >=50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam, Neutrophils >= 1,500/mcL or 50% improvement over baseline without growth factors for at least 4 weeks, Platelets >=100,000/mcL or 50% improvement over baseline, and Hemoglobin >= 11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks. For participants who are transfusion-dependent at baseline, a hemoglobin of >= 9.0 g/dL without transfusions or growth factors for at least 4 weeks.|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790979|NCT00586729|Primary|Percentage of Grafted Area That is Viable at Day 14|Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color|14 days|Per protocol|||Percentage area||Standard Deviation|Mean
2790980|NCT00586729|Secondary|Hospital Cost Per Patient|Average hospital irrigant cost per patient|Volume used from admission to discharge|Per protocol|||Dollars||Standard Deviation|Mean
2790968|NCT00586924|Primary|Number of Participants With Complete Response (CR)|The CR is defined by: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as exhibited by: Neutrophils >= 1,500/microliter (mcL), Platelets >= 100,000/mcL, and Hemoglobin >= 11.0 gram per deciliter (gm/dL) without transfusions or growth factors for at least 4 weeks.|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790969|NCT00586924|Primary|Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)|Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils >= 1,500/mcL, Platelets >= 100,000/mcL, and Hemoglobin >= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: >=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils >= 1,500/mcL, Platelets >=100,000/mcL, and Hemoglobin >= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks.|From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790970|NCT00586924|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.|From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790971|NCT00586924|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree.|From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790972|NCT00586924|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension.|From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790973|NCT00586924|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|The TEAEs are defined as adverse events (AEs) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox.|From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)|Safety population included all participants who received any treatment of moxetumomab pasudotox.|||Participants|||Count of Participants
2790974|NCT00586924|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Adverse events are suspected of causal relationship to drug and are >=Grade (G) 3 in severity considered DLTs: G 3 or 4 hematologic abnormalities at baseline due to disease were not evaluable for hematologic DLT, G 2 allergic reactions of bronchospasm or urticaria, or any >= G3 allergic reaction, in presence of pre-medication were considered DLTs. Following >= G 3 non-hematological treatment-related toxicities not considered DLTs: Tumor lysis syndrome, G 3 low electrolyte levels with pre-existing low levels of same electrolytes, anticoagulant therapy, G 3 or 4 infection or neutropenic fever unless relationship to IP is suspected, G 3 transaminase, alkaline phosphatase, bilirubin or other liver function test elevation provided resolution to values required for study entry prior to start of next cycle, G 3 fever, G 3 hypertriglyceridemia and hypercholesterolemia, and G 4 hypertriglyceridemia lasting <2 months, G 3 hypoalbuminemia lasting <7 days occurred in absence of CLS.|Cycle 1 Day 1 to Cycle 2 Day 10 (each cycle duration was 28 days)|Evaluable population for DLT included all participants who received any treatment of moxetumomab pasudotox, completed at least Cycle 2 Day 10, or discontinued treatment due to a DLT on or before Cycle 2 Day 10.|||Participants|||Count of Participants
2790975|NCT00586898|Primary|Response|Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.|6 months||||participants|||Number
2790976|NCT00586846|Primary|Radiographic Response|to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).|2 years||||participants|||Number
2790981|NCT00586729|Secondary|Length of Stay|Average hospital length of stay in days|0 days, 3 days, 5 days and 14 days post-operation|Per protocol|||Days||Standard Deviation|Mean
2790985|NCT00586703|Primary|Toxicity|Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from mismatched donors: Toxicity including mortality, occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.|8 weeks|Participants who were able to receive infusion.|||participants|||Number
2790986|NCT00586690|Secondary|Efficacy - Disease Progression|Evaluate efficacy of natural killer (NK) cell infusions in terms of number of patients with disease progression.|3 years|Participants who completed cell infusion.|||participants|||Number
2790987|NCT00586690|Secondary|Efficacy - Overall Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of overall survival (OS).|8 years|Participants who completed infusion. 9 patients were still alive at the time of this analysis.|||months alive post-infusion||Full Range|Mean
2790988|NCT00586690|Secondary|Efficacy - Progression Free Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of progression free survival (PFS) in number of months without disease progression.|3 years|Participants who completed cell infusion.|||months||Full Range|Mean
2790989|NCT00586690|Primary|Toxicity|Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting > 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted > 5 days; or treatment-related mortality (TRM). Though these infusions are provided early following transplantation and severe toxicity could still have occurred due to the primary transplant procedure, for this study any aGVHD or other toxicities occurring after the first day of infusion of the natural killer (NK) cell enriched Donor Lymphocyte Infusions (DLIs) is considered here as study related.|5 months|Participants who completed cell infusion.|||participants|||Number
2790990|NCT00586664|Secondary|Ocular Mucus Discharge|"Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 & 20 minutes post-CAC.~Scored as absent or present"|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with OMD Present|||Number
2790991|NCT00586664|Secondary|Tearing|Percent of Eyes with Tearing as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with Tearing Present|||Number
2790992|NCT00586664|Secondary|Total Non-Ocular Composite Symptom|Total Non-Ocular Composite Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790993|NCT00586664|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790994|NCT00586664|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790995|NCT00586664|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790996|NCT00586664|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790997|NCT00586664|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790998|NCT00586664|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2790999|NCT00586664|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2791000|NCT00586664|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2791001|NCT00586664|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2791002|NCT00586664|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2791003|NCT00586625|Primary|Ocular Comfort|"A 4-step grading scale with half unit (1-step) increments allowed:~0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable"|Day 8 & Day 22||||Scores on a scale||Standard Deviation|Mean
2791004|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14).~Period 2 is defined as the administration of the booster dose until the end of the study (Month 15)."|31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.|||subjects|||Number
2791005|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after the booster vaccination (month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.|||subjects|||Number
2791006|NCT00586612|Secondary|Number of Subjects Reporting Solicited Symptoms (Local and General)|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.|During the 4-day follow-up period following booster vaccination|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.|||subjects|||Number
2791007|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||titer||95% Confidence Interval|Geometric Mean
2791008|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|"Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).~Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||mIU/mL||95% Confidence Interval|Geometric Mean
2791009|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2791010|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values|"Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.~Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
2791011|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
2791165|NCT00585546|Secondary|Mean Change in Left Ventricular Ejection Fraction From Device Implant to Completion of Clenbuterol Therapy||up to 16 months, variable based on length of time receiveing clenbuterol|data is available for 9 evaluable subjects at end of clenbuterol|||ejection fraction||Standard Deviation|Mean
2791012|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
2791013|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
2791014|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.|||subjects|||Number
2791015|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire primary vaccination phase|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
2791016|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after each primary vaccination|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
2791017|NCT00586612|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
2791018|NCT00586612|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.|||subjects|||Number
2791019|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||Titer||95% Confidence Interval|Geometric Mean
2791020|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||Titer||95% Confidence Interval|Geometric Mean
2791021|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||mIU/mL||95% Confidence Interval|Geometric Mean
2791022|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||mIU/mL||95% Confidence Interval|Geometric Mean
2791023|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2791024|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2791025|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791026|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791027|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791028|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791029|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791030|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791031|NCT00586612|Secondary|Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter|Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791032|NCT00586612|Secondary|Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791033|NCT00586612|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8|rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||subjects|||Number
2791034|NCT00586612|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.|||subjects|||Number
2791035|NCT00586573|Primary|DSM-IV ADHD Rating Scale (AISRS) Score Change|"AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale.~Score change from baseline."|Endpoint, following 12 weeks Memantine Monotherapy||||Units on a scale||95% Confidence Interval|Mean
2791036|NCT00586521|Secondary|Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire|Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat-population|||Transformed score||Standard Deviation|Mean
2791037|NCT00586521|Secondary|Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score|Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat|||Gilbert score (0-100)||Standard Deviation|Mean
2791038|NCT00586521|Secondary|Number of All Bleeds|Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intention-to-treat|||All bleeds||Standard Deviation|Mean
2791039|NCT00586521|Primary|Number of Joint Bleeds|Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intent-to-treat population|||Number of joint bleeds||Standard Deviation|Mean
2791040|NCT00586495|Post-Hoc|Number of Participants Who Died|Number of subjects who died due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"Overall Survival is shown in Secondary Outcome Measure: Overall Survival."|||participants|||Number
2791041|NCT00586495|Secondary|Overall Disease Control|Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.|||participants|||Number
2791042|NCT00586495|Secondary|Time to Objective Response|Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.|||days||Full Range|Median
2791043|NCT00586495|Secondary|Overall Response Duration|Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.|||days||95% Confidence Interval|Median
2791044|NCT00586495|Secondary|Overall Survival (OS)|Time from initiation of treatment to death due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"ITT population. The median overall survival (OS) and the lower limit of 95% Confidence interval were not estimable because more than half (n=51) of the study population were censored. The number of participant who died is shown in Post-Hoc Outcome Measure: Number of Participants who Died."||||||
2791045|NCT00586495|Secondary|Best Tumor Response|Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population|||participants|||Number
2791046|NCT00586495|Primary|Progression Free Survival (PFS)|Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|Intention to treat (ITT) population.|||days||95% Confidence Interval|Median
2791047|NCT00586482|Other Pre-specified|Self-reported Abstinence From Smoking||Post-operative day 8||||participants|||Number
2791048|NCT00586482|Other Pre-specified|Minnesota Nicotine Withdrawal Score|This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.|Morning of surgery, pre-operatively||||units on a scale||Standard Deviation|Mean
2791049|NCT00586482|Other Pre-specified|Self-reported Time to Last Cigarette||Morning of surgery, pre-operatively||||Hours||Standard Deviation|Mean
2791050|NCT00586482|Secondary|Self-reported Abstinence|Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.|Morning of surgery, pre-operatively||||participants|||Number
2791051|NCT00586482|Primary|Exhaled Carbon Monoxide Concentration||Morning of surgery, pre-operatively||||Parts per million||Standard Deviation|Mean
2791052|NCT00586469|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Within 21 days after vaccination||||participants|||Number
2791053|NCT00586469|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day period following each vaccination.|The analysis was performed on the Total Vaccinated Cohort.|||participants|||Number
2791054|NCT00586469|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face|During the 4-day period following each vaccination.|Analysis was performed on the Total Vaccinated cohort.|||participants|||Number
2791055|NCT00586469|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow up period following vaccination.|Analysis was performed on the Total Vaccinated cohort.|||participants|||Number
2791056|NCT00586469|Secondary|The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B|"The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The fold increase corresponds to the Unit of Measure Factor."|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Factor|||Number
2791057|NCT00586469|Secondary|Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1|Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Factor|||Number
2791058|NCT00586469|Secondary|Number of Seroprotected Participants.|The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||participants|||Number
2791059|NCT00586469|Secondary|Number of Participants Who Seroconverted.|The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.|At Day 21.|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||participants|||Number
2791060|NCT00586469|Secondary|Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains|The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Titer||95% Confidence Interval|Geometric Mean
2791061|NCT00586469|Primary|Geometric Mean Titers (GMTs) of Anti-H3 and B Strains|GMTs for H1 strain is addressed as a secondary endpoint|At Day 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.|||Titer||95% Confidence Interval|Geometric Mean
2791062|NCT00586339|Primary|CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)|The CMI response is the measure of the cytokines production [i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.|At pre-vaccination (Day 0) and at Months 2, 7 and 12|The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||T cells/million cells||Inter-Quartile Range|Geometric Mean
2791063|NCT00586339|Primary|CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 12|The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
2791064|NCT00586339|Primary|CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
2791065|NCT00586339|Primary|CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At Month 2|The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
2791066|NCT00586339|Primary|Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0|The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.|At pre-vaccination (Day 0)|The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
2791067|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies at Month 12|Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.|At Month 12|The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2791068|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7|Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.|At pre-vaccination (Day 0) and Months 2 and 7|The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2791069|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Month 12|Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.|At Month 12|The analysis was performed on ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
2791070|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7|Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.|At pre-vaccination (Day 0) and Months 2 and 7|The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.|||Participants|||Count of Participants
2791071|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12|CD4+ cell count categories, at baseline, assessed were: (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above (>) 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.|||Participants|||Count of Participants
2791072|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7|CD4+ cell count categories, at baseline, assessed were (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.|At Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.|||Participants|||Count of Participants
2791073|NCT00586339|Primary|HIV Viral Load in All HIV+ Subjects at Month 10 and Month 12|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.|||RNA copies/mL (in log10)||Inter-Quartile Range|Median
2791074|NCT00586339|Primary|HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7|The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) [RNA copies/mL (in log10)].|At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.|||RNA copies/mL (in log10)||Inter-Quartile Range|Median
2791075|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimeter in All HIV+ Subjects at Month 10 and Month 12|The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at Month 10 and Month 12 is reported.|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.|||cells/mm^3||Inter-Quartile Range|Median
2791076|NCT00586339|Primary|Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7|The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.|At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.|||cells/mm^3||Inter-Quartile Range|Median
2791077|NCT00586339|Primary|Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12|Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791078|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12|Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Month 10 and Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791079|NCT00586339|Primary|Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7|Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Day 7 and Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791080|NCT00586339|Primary|Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7|Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791081|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7|Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Day 7 and Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791082|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7|Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791083|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7|Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Day 7 and Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791084|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7|Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).|At Day 7 and at Months 1, 2, 4, 6 and 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.|||Participants|||Count of Participants
2791085|NCT00586339|Primary|Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 12|The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2791086|NCT00586339|Primary|Number of Subjects With MSCs From Day 0 up to Month 12|MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2791087|NCT00586339|Primary|Number of Subjects Reporting SAEs From Day 0 up to Month 12|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2791088|NCT00586339|Primary|Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 7|The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2791089|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) From Day 0 up to Month 7|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2791090|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7|Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2791091|NCT00586339|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2791118|NCT00586105|Primary|Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])|The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]).|12 hours after at least 21 days of uninterrupted dosing|A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.|||mg*hour/Liter||Standard Deviation|Mean
2791092|NCT00586339|Primary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination.|Within 7 days after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had their symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2791093|NCT00586339|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Solicited local symptoms were assessed as related to the study vaccination.|Within 7 days after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had their symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2791094|NCT00586326|Secondary|Cosmetic Evaluations Over Time|As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint|At 5 Years|Subjects with Cosmetic Evaluation at 5 Years|||percentage of subjects|||Number
2791095|NCT00586326|Secondary|Disease Free Survival||At 5 Years||||participants||95% Confidence Interval|Number
2791096|NCT00586326|Secondary|Cause Specific Survival||At 5 Years||||participants||95% Confidence Interval|Number
2791097|NCT00586326|Secondary|Overall Survival||At 5 Years||||participants||95% Confidence Interval|Number
2791098|NCT00586326|Primary|Local Control Rate for Follow-up Period of 5 Years.|Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.|Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.||||percentage of subjects|||Number
2791099|NCT00586313|Secondary|The Number of Procedural Complications|Major procedural complications could include: hospitalization, surgery or a radiologic procedure to correct an adverse event; bleeding, infection. Minor procedural complications could be increase in abdominal pain, self-limited hypoxia, bradycardia, tachycardia, hypo or hyper-tension, change in vital signs.|24 months||||complications|||Number
2791100|NCT00586313|Primary|Median Total Specimen Length|Median Total Specimen Length grouped for indication for liver biopsy: Suspected NAFLD, Intrahepatic Cholestasis, Exclusion of Cirrhosis, Increased Liver Function Tests (LFTs) of Uncertain Cause and the Total.|24 months||||mm||Full Range|Median
2791101|NCT00586261|Primary|Change in Brachial Arterial Reactivity|Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient's right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.|After 6 months of treatment|The study was stopped early due to low recruitment and no evidence of an effect in this analysis.|||mm||Standard Error|Mean
2791102|NCT00586196|Secondary|Change From Baseline and MDAS Scores Over Time|Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.|Baseline, hospital discharge, weeks 2, 4 and 6|Based on ability to recruit|||units on a scale||Standard Deviation|Mean
2791103|NCT00586196|Primary|Percentage of Participants With Delirium Using the CAM Over Time|Confusion Assessment Method (CAM)—Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.|Baseline, hospital interviews, weeks 2, 4 and 6||||percentage of participants|||Number
2791104|NCT00586170|Secondary|Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)||24 Weeks|No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed.||||||
2791105|NCT00586170|Primary|Percentage of Successful 5th Metatarsal Unions Achieved.|Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.|24 Weeks|Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups.|||percentage of fractures healed|Fractures||Number
2791106|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks||||Units on a scale||Standard Deviation|Mean
2791134|NCT00586001|Secondary|Work and Social Adjustment Scale|Items are scored on a 0 to 8 scale. The total score range is 0 to 40. Higher scores are more severe. Reported scores are means of total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791135|NCT00586001|Secondary|Beck Anxiety Inventory|Items are scored on a 0 to 3 scale. Total scores range from 0 to 63. 0-9 is minimal, 10-16 is mild, 17-29 is moderate, and 30-63 is severe. Reported scores are a mean of total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791107|NCT00586157|Secondary|Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires|"The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.~Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88"|Baseline and 4 weeks||||Units on a scale||Standard Deviation|Mean
2791108|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks||||Units on a scale||Standard Deviation|Mean
2791109|NCT00586105|Secondary|Time to Objective Response|Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.|Time from start of study medication to first documented PR or CR up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.|||months||Full Range|Median
2791110|NCT00586105|Secondary|Overall Response Duration|Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.|From PR or CR to progression or death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.|||months||Full Range|Median
2791111|NCT00586105|Secondary|Overall Best Response|The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|Best response observed from start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||participants|||Number
2791112|NCT00586105|Secondary|Disease Control (DC)|The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).|From start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||participants|||Number
2791113|NCT00586105|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||months||95% Confidence Interval|Median
2791114|NCT00586105|Secondary|Overall Survival (OS)|Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.|Time from start of therapy to death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||months||Full Range|Median
2791115|NCT00586105|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.|Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.|||months||95% Confidence Interval|Median
2791116|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)].|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.|||Kg/L||Standard Deviation|Mean
2791117|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.|||mg/L||Standard Deviation|Mean
2791164|NCT00585546|Secondary|Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Clenbuterol||baseline to week 8 post clenbuterol|baseline data is based on 19 participants, but different subsequent data collections had different numbers of evaluable subjects listed below|||percent change||Standard Deviation|Mean
2791119|NCT00586066|Secondary|Rapid Visual Information Processing Task (RVP)|"RVP is a sensitive measure of sustained attention. In this test, a white box appears in the center of the screen with digits from 2-9 in a pseudorandom order at a rate of 100 digits per minute. Participants are asked to identify target sequences of three digits and to register responses using the press pad.~RVPA is a measure of target sensitivity (i.e., the ability to discriminate between target and distractors). The outcome is defined as a z-score (statistical deviation from normal). A z-score of 0 is average. Higher z-scores represent better than average performance and negative z-scores represent worse than average performance.~RVPB is an index of response bias (i.e., the tendency to respond or not respond in general). The outcome is defined as a z-score (statistical deviation from normal). A z-score of 0 is average. Higher z-scores represent a stronger tendency to respond and negative z-scores represent a less than average tendency to respond."|Weeks 6 and 12|All randomized participants with data available at the given time-point.|||z-score||Standard Deviation|Mean
2791120|NCT00586066|Primary|California Verbal Learning Test (CVLT) at Week 6|The CVLT is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1, Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile.|Week 6|All Randomized participants with data available at Week 6.|||correct items||Standard Deviation|Mean
2791121|NCT00586066|Primary|California Verbal Learning Test (CVLT) at Week 12|The CVLT is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1, Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile.|Week 12|All Randomized participants with data available at Week 12.|||correct items||Standard Deviation|Mean
2791122|NCT00586001|Secondary|The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)|The TMMS is a 48 item self report where each item can be scored from 1 to 5. The three subscales are Attention, Clarity, and Repair. Scores for each of the three subscales can each range from 16 to 80. Higher scores indicate higher emotion regulation skills.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791123|NCT00586001|Secondary|Intolerance of Uncertainty Scale (IUS)|The IUS is a 27-item self report where each item can be scored from 0 to 4. Scores range from 0 to 108. It rates response to uncertainty, ambiguous situations, and the future. Higher scores indicate higher anxiety and depressive symptoms.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791124|NCT00586001|Secondary|The Thought-Action Fusion Scale (Shafran et al., 1996)|The TAF is a 19 item self report where each item can be scored from 0 to 4. Scores can range from 0 to 76. Higher scores indicate a higher frequency of maladaptive cognitive intrusions.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791125|NCT00586001|Secondary|Anxiety Sensitivity Index|The ASI is a 16 item self report where items can be scored from 0 to 4. Scores can range from 0 to 64. Higher scores indicate a higher sensitivity to anxiety and it's symptoms.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791126|NCT00586001|Secondary|Affective Control Scale|The ACS is a 42 item scale where each item is rated from 1 to 7. Scores can range from 42 to 294. Higher scores indicate higher skill levels for controlling emotions|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791127|NCT00586001|Secondary|BIS/BAS Scales (Carver & White, 1994)|The Behavioral Inhibition System/Behavioral Approach System Scales is a 20-item self-report where all items can be rated from 0 to 3. The total score can range from 0 to 60. Higher scores indicate higher levels of behavioral inhibition skills.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791128|NCT00586001|Secondary|Emotion Regulation Questionnaire - 2|The ERQ-2 is a 16 item self-report. Items are scored from 1 to 7, and focus on emotional experience and emotional expression. Scores can range from 16 to 112, and higher scores indicate stronger cognitive reappraisal and expressive suppression abilities.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791129|NCT00586001|Secondary|Yale-Brown Obsessive Compulsive Scale|The Y-BOCS is a 12-item scale used to see symptom severity of obsessions and compulsions. Items are scored from 0 to 4. The total score can range from 0 to 48. A higher score indicates higher symptom severity.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791130|NCT00586001|Secondary|Quality of Life Inventory|The QOLI is a 32 item self-report, asking about the importance of 16 domains of life and a participant's satisfaction in each domain. Scores can range from -48 to 115. Higher scores indicate higher quality of life.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791131|NCT00586001|Secondary|Social Interaction Anxiety Scale|The SIAS is a twenty-item measure. Experiences are rated on a 5-point scale from 0 to 4. Experiences are rated on a global period of what is typical. A total score of 60 is possible with cutoffs of 34+ indicative of social phobia and 43+ indicative of social anxiety.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791132|NCT00586001|Secondary|Penn State Worry Questionnaire|The PSWQ is a 16-item questionnaire. Items are rated from 1 to 5, and a total score can range from 16 to 80. Higher scores indicate higher severity of worry symptoms.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791133|NCT00586001|Secondary|Panic Disorder Severity Scale - Self Report Version|Items are rated on a scale of 0 to 4. Scores can range from 0 to 28. Higher scores indicate higher severity of Panic Disorder symptoms|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791136|NCT00586001|Secondary|Beck Depression Inventory - II|Items are measured on a scale from 0 (little to no symptoms) to 3 (severe). Total scores can range from 0 to 63, higher ratings are more severe. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. The reported scores are mean total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791137|NCT00586001|Secondary|Positive and Negative Affect Scale|Positive and Negative Affect Schedule-Negative Affectivity; Positive and Negative Affect Schedule-Positive Affectivity; Items are rated on a scale of 1 (very slightly or not at all) to 5 (extremely) relating to how a person feels average feels the indicated emotion. Total scores can range from 20 to 100. Higher scores are more severe. Reported scores are based on mean totals.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791138|NCT00586001|Secondary|Structured Interview Guide for the Hamilton Depression Rating Scale|Structured Interview Guide for the Hamilton Depression Rating Scale, items are scored on scale of 0 to 4, higher score meaning a higher severity. Total scores can range from 0 (no symptoms) to 53 (severe). Reported scores are a mean of the total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791139|NCT00586001|Secondary|Structured Interview Guide for the Hamilton Anxiety Rating Scale|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reported scores are the mean total scores.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791140|NCT00586001|Primary|Anxiety Disorders Interview Schedule for DSM-IV|DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.|Measured at pre-treatment (baseline) and post-treatment (month 3)||||score on a scale||Standard Deviation|Mean
2791141|NCT00585975|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses|Day 1||||Participant|||Number
2791142|NCT00585975|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15||||Participant|||Number
2791143|NCT00585923|Secondary|Level of Function (Neck Disability Index)|Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
2791144|NCT00585923|Secondary|Neurological Status Change in Neurological Status Since Surgery.|Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
2791145|NCT00585923|Secondary|Pain With Activity|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score."|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
2791146|NCT00585923|Secondary|Pain at Rest|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100."|Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)||||Participants|||Number
2791147|NCT00585923|Primary|Fusion Success|"The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views.~Fusion Grading~fused probably fused pseudarthrosis~This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused."|Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study|||participants|||Number
2791148|NCT00585910|Secondary|Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders|Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.|7 weeks||||Units on a Scale||Full Range|Mean
2791149|NCT00585910|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)|The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).|7 weeks|All analyses were intent to treat, with last observation carried forward.|||Units on a Scale||Standard Deviation|Mean
2791150|NCT00585715|Primary|Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.|"At the 6 month follow-up, a blinded assessor ranked change in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change.~Using this scale, the average reduction in cellulite appearance was calculated for each participant that experienced a mild to moderate reduction in cellulite appearance."|6 month follow up|The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.|||units on a scale||Standard Deviation|Mean
2791151|NCT00585715|Primary|Number of Participants With Mild to Moderate Reduction in Cellulite.|"Nurnberger-Muller Scale :~Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down.~Texture Scale:~Hard or Solid: Pinch test firm folds and furrows. Adherent to deep planes. Not modified with lying versus standing position.~Soft or Flaccid: Pinch test spongy and floating folds and furrows. No adherence to deep planes. Not painful, flaccid. Orange peel skin appears spontaneously.~Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency legs in boot/column.~At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change. Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale."|6 month follow up|Only subjects who completed the 6 month follow-up were included in the analysis|||participants|||Number
2791152|NCT00585689|Primary|Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment|The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.|63 days (post 3 cycles)|29 patients were enrolled. 26 of the 29 patients received the planned 3 cycles. 22 of the 26 patients had a cystectomy and were evaluable for the primary endpoint.|||percentage of patients||95% Confidence Interval|Number
2791153|NCT00585650|Primary|The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks|Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, 4 being the most severe.|Week 12|Intention to treat|||participants|||Number
2791154|NCT00585637|Secondary|Change in CRP From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||mg/L||Inter-Quartile Range|Median
2791155|NCT00585637|Secondary|Change in sTNF-R2 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||pg/mL||Inter-Quartile Range|Median
2791156|NCT00585637|Secondary|Change in IL-10 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||pg/mL||Inter-Quartile Range|Median
2791157|NCT00585637|Secondary|Change in IL-6 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|||pg/mL||Inter-Quartile Range|Median
2791158|NCT00585637|Primary|Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.|Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|Baseline, 3months, 6months|Number of participants analyzed above is for baseline. At 3 months, number of participants analyzed was: 71 (no vitamin D), 67 (1000 IU Vitamin D), 76 (2000 IU Vitamin D) and 78 (4000 IU Vitamin D). At 6 months, number of participants analyzed was: 75 (no vitamin D), 68 (1000 IU Vitamin D), 72 (2000 IU Vitamin D) and 77 (4000 IU Vitamin D).|||ng/mL||Inter-Quartile Range|Median
2791159|NCT00585611|Secondary|Changes in Submaximal Exercise Capacity Measured by 6-minute Walk Test||6 months after initiation of intervention|There are no data available.||||||
2791160|NCT00585611|Secondary|Composite Cardiovascular Endpoint Incorporating Quality of Life (QOL) Assessment + Hospitalizations for Cardiovascular Disease and Mortality||6 months after initiation of intervention|There are no data available.||||||
2791161|NCT00585611|Primary|Change in Carotid-femoral Pulse Wave Velocity (CFPWV) in the Statin Treated vs. Control Group||6 months after initiation of intervention|There are no data available||||||
2791162|NCT00585585|Primary|Maximum Tolerable Dose of Betahistine Dihydrochloride in mg|The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.|7 weeks|The patient did not complete the study and not enough data were collected to be analyzed.||||||
2791163|NCT00585546|Secondary|Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 1 Year Following Device Implant|Scale 0 - 105 (0- 5 on 21 items) where 0 means heart failure has not limited daily life at all and high scores mean that daily functions are greatly limited.|1 year|Data is not available for Minnesota Living with Heart Failure Questionnaire at the 12 month time point.||||||
2791166|NCT00585546|Secondary|Mean Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to 6 Months|Scale 0 - 105 (0- 5 on 21 items) where 0 means heart failure has not limited daily life at all and high scores mean that daily functions are greatly limited.|6 months following LVAD implantation|Only 11 participants provided usable data at the six month time point.|||units on a scale||Standard Deviation|Mean
2791167|NCT00585546|Secondary|Mean Change in EuroQoL Visual Analog Scale (EQ5D-VAS) From Baseline to 6 Months and 1 Year Following Device Implant|Scale 0 - 100 where 0 is worst possible health state and 100 is perfect health.|1 year following LVAD implantation|While baseline data was available for 13 participants at baseline, (start of clenbuterol), different numbers of participants provided evaluable data At six months post implant and 12 months, so the mean changes are based on the actual population that provided both data points as listed below|||units on a scale||Standard Deviation|Mean
2791168|NCT00585546|Secondary|Absolute Percent Change in Serum Creatinine and Aspartate Transaminase (AST) From Baseline to Week 8 Post Implant||Up to 8 weeks after LVAD implantation|Because data only is available for 15 participants for 8 week post implant AST value, it has a different participants analyzed value|||percent change||Standard Deviation|Mean
2791169|NCT00585546|Secondary|Absolute Change in Left Ventricular Ejection Fraction From Explant to 18 Months Following Device Explant||18 months after explantation||||absolute change in ejection fraction|||Number
2791170|NCT00585546|Secondary|Time to Device Explant for Subjects Meeting Explant Criteria Defined in the Protocol|Time from LVAD placement to explant for the single participant who achieved explant|Time to explant (but not to be followed for more than 16 months)||||weeks|||Number
2791171|NCT00585546|Secondary|Number of Subjects Who Received Maximum Target Dose of Clenbuterol||Up to 16 months after LVAD implantation (12 months after beginning clenbuterol)||||Participants|||Count of Participants
2791172|NCT00585546|Secondary|The Number of Evaluable Subjects Meeting Explant Criteria and Subsequently Explanted||Maximum 12 months after LVAD implantation|"Because only 13 began Clenbuterol, only 13 are evaluable for this purpose."|||Participants|||Count of Participants
2791173|NCT00585546|Primary|Percent of Subjects Who Experience LVAD Removal and Subsequent Freedom From Mechanical Circulatory Support or Heart Transplantation for 1-year After Explantation||One year after LVAD explant or until transplant or death (if not explanted)||||percentage of participants|||Number
2791174|NCT00585533|Secondary|Overall Survival|Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.|24 months||||weeks||95% Confidence Interval|Median
2791175|NCT00585533|Primary|Survival Rate at 6-months Chemotherapy-progression-free (CP-free)|Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.|6 months||||percentage of participants|||Number
2791176|NCT00585494|Secondary|Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.||1 year|||||||
2791177|NCT00585494|Secondary|Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.||1 year|||||||
2791178|NCT00585494|Primary|Prevalence of Hyperglycemia in the Elective Orthopedic Population|Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively|1 year||||patients|||Number
2791179|NCT00585468|Primary|Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||mcg*h/mL||Standard Deviation|Mean
2791180|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||hours||Full Range|Median
2791181|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
2791182|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
2791183|NCT00585468|Primary|Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||mcg*h/mL||Standard Deviation|Mean
2791184|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||hours||Full Range|Median
2791185|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
2791186|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose||||micrograms per milliliter||Standard Deviation|Mean
2791187|NCT00585377|Secondary|Evaluation of Response Rate|The percentage of patients in which response (CR + PR) was observed: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|2 years||||percentage of participants||95% Confidence Interval|Number
2791188|NCT00585377|Secondary|Evaluation of Progression-free Survival|The length of time during and after bevacizumab-erlotinib that a patient lives with the disease but does not progress according to RECIST 1.0 Criteria. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions|2 years||||weeks||95% Confidence Interval|Median
2791189|NCT00585377|Primary|Evaluation of Overall Survival|The length of time from the start of treatment for a disease that patients are still alive.|2 years|All patients were included in response assessment based on intention to treat including those who received less than 6 weeks of therapy|||weeks||95% Confidence Interval|Median
2791190|NCT00585351|Secondary|Prevention of Chemical Pneumonitis|Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).|Assessed on the day of discharge (average length of stay is approximately 3-7 days)|Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).|||Participants|||Number
2791191|NCT00585351|Primary|The Benefit of Advanced Notification in Promoting Informed Consent|Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).|Assessed at time of enrollment into the study.|Intention to treat analysis for primary outcome (number of patients consented).|||Participants|||Number
2791192|NCT00585325|Primary|Pain During Dressing Change|A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)|During dressing change||||units on a scale|VAC dressing changes|Standard Deviation|Mean
2791193|NCT00585312|Secondary|Colorectal Polyp Burden|"The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively.~Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.|||mm||Standard Deviation|Mean
2791194|NCT00585312|Secondary|Total Number of Colorectal Polyps|"Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively.~Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.|||polyps||Standard Deviation|Mean
2791195|NCT00585312|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:~Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or~Diagnosis of colorectal malignancy (ColMal), or~Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Secondary outcome measure was met by 14 (Polyp:7,ColMal:0,DO:14) participants in the Celecoxib and 14 (13,0,12) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.|||years||Standard Deviation|Mean
2791196|NCT00585312|Primary|Time to Disease Progression|"Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:~Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or~Diagnosis of colorectal malignancy (ColMal)."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.|||years||Standard Deviation|Mean
2791197|NCT00585286|Secondary|Pain Tolerance|"The average pain score reported over all three treatments was 5.67, corresponding to moderate pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being no pain and 10 being worst pain imaginable. All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy."|At treatment visit (up to 3 visits)|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Mean
2791198|NCT00585286|Primary|Degree of Atrophy|Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Median
2791199|NCT00585286|Primary|Average Improvement in Surface Texture|Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Median
2791200|NCT00585286|Primary|Overall Improvement of Acne Scarring|Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.|||units on a scale||Standard Deviation|Mean
2791201|NCT00585247|Primary|Change From Baseline in a* and E at 8 Weeks|Change in a* and ΔE is a way to quantify PWS treatment outcome: a* is the erythema of the vascular lesions and varies from +60 for green to −60 for red with a value of +9.28 for Normal Skin. Higher a* values indicates a greater reduction in erythema hence better treatment outcome. ΔE detects all three dimensions of colorspace (L*a*b*) and represents the difference in color between normal and PWS skin. Range of ΔE is 0 to 100. Higher values indicates improved treatment efficacy by greater skin color improvement.|8 weeks baseline||||units on a scale||Standard Deviation|Mean
2791202|NCT00585221|Primary|Time to Progression (TTP).||two years|||||||
2791203|NCT00585221|Primary|Decrease in Tumor Size.|Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).|18 months|||||||
2791204|NCT00585182|Secondary|Clinically Relevant Bleeding Events|Clinically Relevant Bleeding is defined as fatal bleeding, symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells, or bleeding requiring intervention|Participants were followed for the duration of hospital stay, an average of 5 days||||Events|||Number
2791205|NCT00585182|Primary|Peak Low Molecular Weight Heparin Anti-Xa Activity Level.|The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL|4 - 6 hours after enoxaparin dosing on Day 1 and Day 2||||IU/mL||Standard Deviation|Mean
2791206|NCT00585169|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.|Baseline to study end point (10 weeks)|All participants who completed at least one study visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
2791207|NCT00585104|Primary|Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.|Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.|From baseline to 30-minutes after levosimendan started.|Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed.|||mmHg||Standard Deviation|Mean
2791208|NCT00585078|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from treatment or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease evaluations occurred every two cycles (42 days ±2 days) on treatment. In this study cohort, participants were followed for progression up to 38 months.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.|||months||95% Confidence Interval|Median
2791209|NCT00585078|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 10.8 months (95% CI: 7.1-37.7) in this study cohort.|The analysis dataset is comprised of treated participants.|||months||95% Confidence Interval|Median
2791210|NCT00585078|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.|||participants|||Number
2791211|NCT00585078|Primary|Response Rate|Response rate (RR) is defined as the proportion of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every two cycles (42 days ±2 days) on treatment. Participants received a median (range) of 2 cycles (1-12) of CAPOX.|The analysis dataset is comprised of response evaluable participants which required completion of two cycles of treatment.|||proportion of participants||80% Confidence Interval|Number
2791212|NCT00585052|Secondary|Time to Progression Using the Combination of Lovastatin and Paclitaxel.|To determine the time to progression using the combination of lovastatin and paclitaxel.|Up to one year||||years||Standard Deviation|Mean
2791229|NCT00584935|Secondary|2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks||24 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
2791213|NCT00585052|Primary|Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.|"Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination~Clinical Examination: Clinically detected lesions will only be considered measurable when they are superficial (e.g. skin nodules and palpable lymph nodes.)~Image based evaluation (CT and MRI): Conventional CT and MRI are currently the most reproducible methods of measuring lesions for response assessment."|8 weeks||||Participants|||Count of Participants
2791214|NCT00585039|Secondary|Clinical Asthma Score (CAS)|Change in clinical asthma score while in ED. 15 point clinical asthma score. Score ranges from 5 (no to mild respiratory distress) to a maximum of 15 (severe respiratory distress).|4 hours|analysis per protocol|||units on a scale||95% Confidence Interval|Mean
2791215|NCT00585039|Primary|Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec||Baseline and 4 hours|Enrollment period ended prior to final goal sample size. ITT.|||L/sec||95% Confidence Interval|Mean
2791216|NCT00585013|Secondary|Incidence of Methhemoglobin >5%, Gene Expression Profiles, and S100B.||48 hours|Data not collected for these assessments||||||
2791217|NCT00585013|Primary|Ischemic Injury as Measured by Lactate Levels|Lactate levels correlate to ischemic injury. Higher values represent more injury.|48 hours||||mmol/L||Standard Deviation|Mean
2791218|NCT00585013|Primary|Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels|BNP levels correlate to ventricular and myocardial performance, function, and strain. Higher values represent greater strain and decreased function.|48 hours||||pg/dL||Standard Deviation|Mean
2791219|NCT00585013|Primary|Myocardial Injury|Troponin levels correlate with myocardial injury. Greater troponin levels represent greater myocardial injury|48 hours||||ng/mL||Standard Deviation|Mean
2791220|NCT00585013|Primary|Serum Inflammatory Mediators Post CPB|Inflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h.|48 hours||||ng/mL||Standard Deviation|Mean
2791221|NCT00584987|Secondary|Total NPIF|Nasal peak inspiratory flow (NPIF) is a physiological measure of nasal airflow which is particularly sensitive to nasal valve collapse. NPIF was measured objectively in liters per minute with an In-Check Peak Inspiratory FlowMeter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and recorded the best flow measured. The morning and evening NPIF measurements were summed for days 2 through 28 of the treatment cycle, yielding the total NPIF outcome measure. NPIF scores increase with air flow quality (i.e., higher NPIF values are indicative of better nasal air flow).|days 2 through 28 of the treatment cycle||||liters per minute||Full Range|Median
2791222|NCT00584987|Secondary|RQLQ Score [6 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 6 weeks after initiation of treatment regimen||||units on a scale||Standard Error|Mean
2791223|NCT00584987|Secondary|RQLQ Score [4 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 4 weeks after initiation of treatment regimen||||units on a scale||Standard Error|Mean
2791224|NCT00584987|Secondary|RQLQ Score [2 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 2 weeks after initiation of treatment regimen||||units on a scale||Standard Error|Mean
2791225|NCT00584987|Secondary|RQLQ Score [Baseline]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed at baseline||||units on a scale||Standard Error|Mean
2791226|NCT00584987|Primary|Total Nasal Congestion Symptom Score|The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).|28 days of treatment||||units on a scale||Full Range|Median
2791227|NCT00584948|Primary|Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale|The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2|1 year||||m/s^2||Standard Deviation|Mean
2791228|NCT00584948|Primary|Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)|The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.|One Year||||units on a scale||Standard Deviation|Mean
2791230|NCT00584935|Secondary|1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks||16 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
2791231|NCT00584935|Primary|2. The Proportion of Patients That Experience a Grade 3, Grade 4, or Grade 5 Toxicity Based Reaction on the NCI-CTC System at the Time of Their Infusions and During Follow-up Visits.||16 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
2791232|NCT00584935|Primary|Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks|"Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)~0-25%~25-50%~50-75%~75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by symblepharons and n is the number of symblepharons countable)~a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe"|16 weeks|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
2791233|NCT00584922|Primary|Incidence of Esophageal Injury as Assessed by Endoscopy|Endoscopy results and clinical status at one month after endoscopy procedure.|1 month||||participants|||Number
2791234|NCT00584909|Secondary|Toxicity|Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version|4 years||||participants|||Number
2791235|NCT00584909|Primary|Disease-free Survival|Number of months of survival with no evidence of disease|4 years - Median follow up time of 45.3 months||||months||Full Range|Median
2791236|NCT00584857|Secondary|Toxicity|Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria|3 years||||participants|||Number
2791237|NCT00584857|Primary|3-year Overall Survival|Number of subjects alive at 3 years|3 years - median followup of 40.4 months||||partipants|||Number
2791238|NCT00584844|Secondary|Immunogenicity: Protocol-compliant Post-boost 2 Titer|"Percentage of subjects with less than or greater than titers who received post-boost 2.~Responder = > 1:20 Non-responder = < 1:20"|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 18 were compliant and analyzed.|||Percentage of subjects|||Number
2791239|NCT00584844|Secondary|Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates|Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 19 were compliant and analyzed.|||Percentage of subjects|||Number
2791240|NCT00584844|Secondary|Immunogenicity: Protocol Compliant Post-primary Titer Rates|Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.|12 months|As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 454 were compliant and analyzed.|||Percentage of subjects|||Number
2791241|NCT00584844|Primary|Safety: Adverse Event Category Rates for All Vaccinations|AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.|AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year||||Adverse events|||Number
2791242|NCT00584831|Primary|Visual Acuity After Superior-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion||||LogMAR units||Standard Deviation|Mean
2791243|NCT00584831|Primary|Visual Acuity After Superior-temporal Version Movement|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion||||LogMAR units||Standard Deviation|Mean
2791244|NCT00584831|Primary|Visual Acuity After Infero-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion||||LogMAR units||Standard Deviation|Mean
2791245|NCT00584831|Primary|Visual Acuity After Infero-temporal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after insertion||||LogMAR units||Standard Deviation|Mean
2791246|NCT00584805|Secondary|Number of Subject Experiencing Local and Systemic Adverse Events|Number of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster.|vaccination/booster days 0-28 for up to 5 years||||Participants|||Count of Participants
2791247|NCT00584805|Primary|Response Rates of Annual (11-13 Months) PRNT80 Titers|Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.|Months 11-13|Only observations or specimens collected according to the protocol were included in the analyses|||Participants|||Count of Participants
2791248|NCT00584805|Primary|Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers|Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.|Post booster 1, days 21-35|Only observations or specimens collected according to the protocol were included in the analyses|||Participants|||Count of Participants
2791292|NCT00583947|Primary|Mean Serum Glucose Values||Predose, 2 and 6 hours post dose 1|Intent to treat population|||mg/dl||Standard Deviation|Mean
2791249|NCT00584805|Primary|Response Rates of Post Month 6: Day 21-35 PRNT80 Titers|Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.|Post month 6, days 21-35|Only observations or specimens collected according to the protocol were included in the analyses|||Participants|||Count of Participants
2791250|NCT00584805|Primary|Response Rates of Pre-Month 6 PRNT80 Titers|Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.|Pre-month 6|Only observations or specimens collected according to the protocol were included in the analyses|||Participants|||Count of Participants
2791251|NCT00584805|Primary|Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers|Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.|Post dose 2, days 21-35|Only observations or specimens collected according to the protocol were included in the analyses|||Participants|||Count of Participants
2791252|NCT00584805|Primary|Subject Response Rates for PRNT80 Titers|"Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.~Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution)."|5 years|Only observations or specimens collected according to the protocol were included in the analyses|||Participants|||Count of Participants
2791253|NCT00584740|Primary|Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|6 weeks|Safety Analysis Set: the safety set included all participants.|||score on a scale||Standard Deviation|Mean
2791254|NCT00584740|Secondary|Percentage of Participants Maintaining Remission|Remission was defined as CDAI < 150 points.|10 weeks|The analysis population included participants of the safety set who achieved remission.|||Percentage of participants|||Number
2791255|NCT00584740|Secondary|Area Under CDAI Curve|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.|10 weeks|Safety Analysis Set: the safety set included all participants.|||Units on a scale*day||Standard Error|Least Squares Mean
2791256|NCT00584740|Secondary|Mean Change From Baseline in CDAI Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|baseline, 2 weeks, 4 weeks|Safety Analysis Set: the safety set included all participants.|||score on a scale||Standard Deviation|Mean
2791257|NCT00584740|Secondary|Percentage of Participants Achieving Response|Response was defined as CDAI reduction of at least 70 points from baseline.|6 weeks|Safety Analysis Set: the safety set included all participants.|||Percentage of participants|||Number
2791258|NCT00584740|Secondary|Percentage of Participants Achieving Remission|Remission was defined as CDAI < 150 points.|6 weeks|Safety Analysis Set: the safety set included all participants.|||Percentage of participants|||Number
2791259|NCT00584740|Secondary|Percentage of Participants Achieving Remission and/or Response|Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.|6 weeks|Safety Analysis Set: the safety set included all participants.|||Percentage of participants|||Number
2791260|NCT00584727|Primary|Patient Preference|This outcome measures which lens the subjects preferred to wear.|end of study|Analysis includes participants who completed the study per protocol (n=88)|||Number of participants|||Number
2791261|NCT00584727|Primary|Patient Reported Comfort.|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)|||Scores on a scale||Standard Error|Least Squares Mean
2791262|NCT00584727|Primary|Lens Stability Within 5 Degrees|Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)|||degrees|||Number
2791263|NCT00584727|Primary|Lens Orientation Within 5 Degrees|Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)|||degrees|||Number
2791264|NCT00584727|Primary|Patient Reported Vision|A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision.|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)|||Scores on a scale||Standard Error|Least Squares Mean
2791265|NCT00584727|Primary|Visual Acuity|Number of eyes with Distance Visual Acuity 20/20 or better|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)|||Eyes with Snellen VA 20/20 or better|||Number
2791266|NCT00584701|Secondary|Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I|"Affymetrix GeneChip Human Exon 1.0 ST Arrays (Affymetrix, Santa Clara, CA, USA) were used to obtain gene expression values. Raw data (Affymetrix.CEL files) was imported into Partek Genomics Suite 6.4 (Partek, St Louis, MO, USA). Probe summarization and probe set normalization were performed using robust multichip average, which included background correction, quantile normalization, log2 transformation and median polish probe set summarization.~Exons in genes correlated with percentage improvement on the Aberrant Behavior Checklist Irritability subscale were identified."|Baseline, 8 Weeks||||Number of Correlated Genes|||Number
2791267|NCT00584701|Primary|Percent Change of ABC - Irritability Subscale Score|"Aberrant Behavior Checklist-Irritability (ABC-I)subscale: measure of assessing changes in symptoms of irritability in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. There are 45 items that are rated on a 4-point scale from no problem to major problem. ABC-I scores ranges from 0 (best) to 45 (worst). A negative change signifies improvement.~We measured percent change of ABC-I scores from 8 weeks after risperidone treatment compared to baseline."|Baseline, 8 weeks||||percent change in scores||Full Range|Mean
2791268|NCT00584558|Secondary|Number of Patients With Complications From Catheter Ablation|Number and % of patients with major adverse events as recorded in the medical record|0-10 years||||Participants|||Count of Participants
2791269|NCT00584558|Primary|Number of Patients With Arrhythmia Recurrence|Number and % patients with documented arrhythmias recurrences|0-10 years|Patients who underwent ablation of arrhythmias|||Participants|||Count of Participants
2791270|NCT00584480|Primary|Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score|Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.|Baseline, 8 Weeks from baseline, and 20 Weeks from baseline||||participants|||Number
2791271|NCT00584454|Primary|The Adverse Reaction and Occupational Illness Endpoint Measurements in This Q Fever NDBR 105 Vaccine Study Will be Evaluated for All Intent-to-treat Volunteers.|Observe adverse reactions and occupational illness endpoint measurements 7 days follow-up after receipt of skin test antigen and 12 months of follow-up after receipt of vaccine|AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study|Subjects at risk of exposure to Coxiella Burnetti (Q Fever)|||Participants|||Count of Participants
2791272|NCT00584415|Secondary|Total Number of Significant Ablation Procedure Related Complications|Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.|0-1 year||||Complications|||Number
2791273|NCT00584415|Primary|Atrial Tachyarrhythmia Recurrence in Participants|Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.|0-5 years|all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included|||participants|||Number
2791274|NCT00584402|Secondary|Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth|Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type|15 min|Tumor types showed differences in enhancement|||participants|||Number
2791275|NCT00584402|Primary|Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography|After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.|15 min|Tumors were evaluated prior and post contrast injection, 1 tumor per participant|||tumor|tumor||Count of Units
2791276|NCT00584285|Primary|Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns|Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.|Baseline first visit||||participants|||Number
2791277|NCT00584220|Primary|Subject Reported Lens Comfort.|A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Deviation|Least Squares Mean
2791278|NCT00584220|Primary|Subjective Reported Vision|A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Deviation|Least Squares Mean
2791279|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers After 6-month Booster|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.|month 6 after dose 4|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
2791280|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers at 12 Months|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.|at 12 months|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
2791281|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers Before 6-month Booster|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B|Before 6-month booster|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
2791282|NCT00584194|Secondary|Immunogenicity: Geometric Mean Titers After 3rd Vaccination|Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)|28 days after dose 3|Population is based on responders (defined as a subject achieving a PRNT80 >1:40)|||Titers||95% Confidence Interval|Geometric Mean
2791283|NCT00584194|Primary|Safety: All Incidences of Erythema|Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study|12 months||||number of events|||Number
2791284|NCT00584077|Secondary|to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year|"Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis. Lung transplant recipients underwent airway evaluations using the above protocel at 1.5 and 12 months after lung transplantation.~after undergoing transplantation"|15-20 minutes|Stable lung transplant recipients|||Coughs|Coughs|Standard Deviation|Mean
2791285|NCT00584077|Primary|Number of Coughs|The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).|15-20 minutes||||Coughs||Standard Deviation|Mean
2791286|NCT00584012|Primary|Incidence of Dose-limiting Toxicities (DLTs)|To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.|27 weeks|Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.||||||
2791287|NCT00583947|Secondary|Plasma Concentration of (R,R) Formoterol|If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.|predose, various postdose times|PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available.|||picogram/milliliter||Standard Deviation|Mean
2791288|NCT00583947|Secondary|Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.|||liters/second||Standard Deviation|Mean
2791289|NCT00583947|Secondary|Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.|||liters/second||Standard Deviation|Mean
2791290|NCT00583947|Secondary|Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.|predose, various postdose timepoints|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses|||liters||Standard Deviation|Mean
2791291|NCT00583947|Primary|Change From Predose in Mean Serum Glucose|Change in mean serum glucose at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population|||mg/dl||Standard Deviation|Mean
2791293|NCT00583947|Primary|Change From Predose in Mean Serum Potassium|Change in mean serum potassium at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population|||mEq/L||Standard Deviation|Mean
2791294|NCT00583947|Primary|Mean Serum Potassium Levels||Predose, 2 hours and 6 hours postdose 1|Intent to treat population|||mEq/L||Standard Deviation|Mean
2791295|NCT00583947|Primary|Change From Predose in Mean Diastolic Blood Pressure|Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
2791296|NCT00583947|Primary|Mean Diastolic Blood Pressure|Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
2791297|NCT00583947|Primary|Change From Predose in Mean Systolic Blood Pressure|Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
2791298|NCT00583947|Primary|Mean Systolic Blood Pressure|Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||mmHg||Standard Deviation|Mean
2791299|NCT00583947|Primary|Change From Predose in Mean Heart Rate|Heart rate measured at various timepoints minus the heart rate at predose.|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||beats per minute||Standard Deviation|Mean
2791300|NCT00583947|Secondary|Mean Forced Expiratory Volume in One Second(FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.|||liters||Standard Deviation|Mean
2791301|NCT00583947|Primary|Mean Heart Rate|Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population|||beats per minute||Standard Deviation|Mean
2791302|NCT00583908|Secondary|Degree of Lens Rotation in Inferior Gaze.|Degree of lens rotation while participant is gazing down.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||Degree of rotation||Standard Deviation|Mean
2791303|NCT00583908|Secondary|Degree of Lens Rotation in Inferior-nasal Gaze.|Degree of lens rotation while participant is gazing down and in.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||Degree of rotation||Standard Deviation|Mean
2791304|NCT00583908|Secondary|Degree of Lens Rotation Inferior-temporal Gaze.|Degree of lens rotation while participant is gazing down and out.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||Degree of rotation||Standard Deviation|Mean
2791305|NCT00583908|Secondary|Degree of Lens Rotation in Nasal Gaze.|Degree of lens rotation while participant is gazing in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
2791306|NCT00583908|Secondary|Degree of Lens Rotation in Temporal Gaze.|Degree of lens rotation while participant is gazing out(towards the temple).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
2791307|NCT00583908|Secondary|Degree of Lens Rotation in Superior-nasal Gaze.|Degree of lens rotation while participant is gazing up and in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
2791308|NCT00583908|Secondary|Degree of Lens Rotation in Superior-temporal Gaze.|Degree of lens rotation while participant is gazing up and out(towards the temple).|After each of 4 lens insertions.,|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
2791309|NCT00583908|Secondary|Degree of Lens Rotation in Superior Gaze.|Degree of lens rotation while participant is gazing up.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
2791310|NCT00583908|Primary|Visual Acuity During Head Tilt|"logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity.~logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal."|after each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.|||logMAR units||Standard Deviation|Mean
2791311|NCT00583908|Primary|Lens Orientation During Head Tilt.|Degree of lens rotation on the eye with the head tilted.|after fit of each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.|||Degree of rotation||Standard Deviation|Mean
2791312|NCT00583804|Secondary|Adverse Events|Self-reported adverse events.|From date of implant until study completion or date of death from any cause.|||||||
2791329|NCT00583596|Primary|Reporting of Late Adverse Events Relating to the Device.||Long term follow up for data captured at 5, 6 or 7 years post implant|152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up.|||participant|||Number
2791330|NCT00583557|Secondary|The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).|NOT ANALYZED|up to 5 Years|||||||
2791313|NCT00583804|Primary|Activities of Daily Living Test|"The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) Physical Assistance (PA): assistance from an attendant, 2) Adaptive Equipment (AE): any modifications of the activity or its components, 3) Orthotic Assistance (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) Self Assistance (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) Independent."|Three months||||Number of Tasks Improved||Full Range|Median
2791314|NCT00583804|Primary|Grasp-Release Test|Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.|One Year||||Number of Objects||Full Range|Median
2791315|NCT00583791|Primary|Closure of Muscular Ventricular Septal Defects|Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder|5 years||||participants|||Number
2791316|NCT00583713|Primary|Elimination Rate Constant||1 day||||1/hr||Standard Deviation|Mean
2791317|NCT00583713|Primary|Area Under the Curve for the 24-hour Dosing Interval||1 day||||µmol*hr/L||Standard Deviation|Mean
2791318|NCT00583713|Primary|Terminal Half-life||1 day||||hours||Standard Deviation|Mean
2791319|NCT00583713|Primary|Time to Maximum Concentration||1 day||||hours||Standard Deviation|Mean
2791320|NCT00583713|Secondary|Urinary Sulfate Concentration||pre-dose to 6 days post-dose||||mg/dL||Standard Deviation|Mean
2791321|NCT00583713|Primary|Maximum Observed Concentration (Cmax)||1 day||||µmol/L||Standard Deviation|Mean
2791322|NCT00583700|Secondary|Tissue Compliance|"Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it.~One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement.~The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm."|18 months post-treatment|All study participants enrolled were to be measured at 18 months post-radiotherapy. The number of participants analyzed varied by the number compliant with study schedule.|||milimeters (mm)||Standard Deviation|Mean
2791323|NCT00583700|Primary|Subjective, Objective, Management, and Analytic (SOMA) Score|A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.|18 month post-treatment|All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.|||units on a scale||Standard Deviation|Mean
2791324|NCT00583661|Primary|Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.|Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.|Participants were followed while on device support, an average of 58 days|All subjects implanted with the device were included in this analysis.|||participants|||Number
2791325|NCT00583661|Primary|The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.|The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.|Participants were followed while on device support, an average of 58 days|All 48 participants were included in the analysis. Adverse Events for each participant was counted and the total number of events was divided by the total time the Cohort's subjects were supported on device. A 95% Poisson confidence interval was calculated around the point estimates.|||Events per patient-day||95% Confidence Interval|Number
2791326|NCT00583622|Secondary|Participant Response|Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.|Up to 6 months|One participant was not evaluable for response as participant expired prior to performing restaging evaluation.|||percentage of participants|||Number
2791327|NCT00583622|Primary|Event-Free (EF) Rate|Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.|Up to 6 Months|Due to the small number of patients treated, 12 out of 30 planned, an analysis was not possible.||||||
2791328|NCT00583596|Primary|Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure|The number of participants with a residual shunt (efficacy)|Long term follow up data captured at 5, 6 or 7 years post implant|Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit.|||participants|||Number
2791332|NCT00583492|Secondary|Decrease in Quality of Life|Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20|3 years||||participants|||Number
2791333|NCT00583492|Secondary|Disease-specific Survival||10 years||||participants|||Number
2791334|NCT00583492|Secondary|Freedom From Distant Metastases||10 years||||participants|||Number
2791335|NCT00583492|Secondary|Positive Prostate Biopsy at 2 Years||2 years||||participants|||Number
2791336|NCT00583492|Secondary|Acute >= Grade 3 Treatment-related Toxicity|This metric includes both expected and unexpected events Toxicities were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3|90 days||||percentage of adverse events|||Number
2791337|NCT00583492|Primary|Freedom From Biochemical/Clinical Failure (FFF)|Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL|5 years||||participants|||Number
2791338|NCT00583466|Primary|Duration of the Submucosal Cushion||Immediately after the procedure, Up to 5 minutes|No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.||||||
2791339|NCT00583453|Secondary|Total Morphine Equivalent|Participant reported mophine equivalent use|From operative day through 10 days post-operative||||mg||Standard Error|Mean
2791340|NCT00583453|Secondary|Incidence of Post-operative Hemorrhage|The incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.|From operative day through 10 days post-operative||||Participants|||Count of Participants
2791341|NCT00583453|Secondary|Acetaminophen Equivalent Use|Participant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.|From operative day through 10 days post-operative||||mg||Standard Error|Mean
2791342|NCT00583453|Secondary|Self-reported Activity Level|Activity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.|From operative day through 10 days post-operative||||Activity score (units on a scale)||Standard Error|Mean
2791343|NCT00583453|Primary|Self-reported Pain Score|Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.|day of procedure through post-operative day 10||||pain score (units on a scale)||Standard Error|Mean
2791344|NCT00583414|Primary|Freedom From Aneurysm Rupture|Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan|2 years||||Participants|||Count of Participants
2791345|NCT00583375|Secondary|SF-12 Physical Component Score|"The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.~Maintenance or improvement: ≥0 point increase from baseline~Slight Decline: 0-10 point decrease from baseline~Deteriorated: >10 point decrease from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
2791346|NCT00583375|Secondary|AOFAS Hindfoot and Ankle Score|"Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.~Clinically significant improvement: ≥20 point increase from baseline~Improved: 10-20 point increase from baseline~Maintained: <10 point increase from baseline and <10 point decrease from baseline~Deteriorated: >10 point decrease from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
2791347|NCT00583375|Secondary|Foot Function Index (FFI)|"The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.~Clinically significant improvement: ≥10 point decrease from baseline~Improved: 5-10 point decrease from baseline~Maintained: <5 point decrease from baseline and <5 point increase from baseline~Deteriorated: >5 point increase from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
2791348|NCT00583375|Secondary|Pain at Fusion Site|"Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).~Clinically significant improvement: ≥20mm decrease from baseline~Detectable improvement: 10-20mm decrease from baseline~Maintained: <10mm decrease from baseline and <10mm increase from baseline~Deteriorated: >10mm increase from baseline"|24 and 52 weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
2791349|NCT00583375|Secondary|Pain on Weight Bearing|"Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).~Clinically significant improvement: ≥20mm decrease from baseline~Detectable improvement: 10-20mm decrease from baseline~Maintained: <10mm decrease from baseline and <10mm increase from baseline~Deteriorated: >10mm increase from baseline"|24 and 52 Weeks|Analysis conducted on patients at 24 and 52 weeks time points.|||Participants|||Count of Participants
2791350|NCT00583375|Primary|Subjects Fused at 24 Weeks (as Determined by CT Assessment)|An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.|24 weeks|The mITT population consisted of 397 patients (414 patients in the Safety group minus 17 subjects excluded post-operatively).|||Participants|||Count of Participants
2791374|NCT00583219|Secondary|Median Urogenital Distress Inventory (UDI-6) Scores|The UDI-6 was one measure of urinary-associated quality of life. The UDI-6 questionnaire has 6 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 18, a higher score indicating greater distress.|baseline, 1 month, 3 months||||units on a scale||Inter-Quartile Range|Median
2791351|NCT00583362|Secondary|Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points|Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percent change||Full Range|Median
2791352|NCT00583362|Secondary|Absolute Serum Immunoglobulin G Values at Indicated Time Points|Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams per liter||Full Range|Median
2791353|NCT00583362|Secondary|Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points|Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percentage of participants|||Number
2791354|NCT00583362|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points|Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percent change||Full Range|Median
2791355|NCT00583362|Secondary|Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points|Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams per liter||Full Range|Median
2791356|NCT00583362|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points|Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percent change||Full Range|Median
2791357|NCT00583362|Secondary|Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points|Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.|Approximately up to 13 years|MITT Population. Only those participants positive at Baseline and available at the specified time points (represented by n=X in the category titles) were analyzed.|||International units (IU)/milliliter (mL)||Full Range|Median
2791358|NCT00583362|Secondary|Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points|SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percentage of participants|||Number
2791359|NCT00583362|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||International units per liter||Standard Deviation|Mean
2791360|NCT00583362|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Ratio||Standard Deviation|Mean
2791361|NCT00583362|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||micromoles per liter||Standard Deviation|Mean
2791362|NCT00583362|Primary|Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||millimoles per liter||Standard Deviation|Mean
2791363|NCT00583362|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams/liter||Standard Deviation|Mean
2791364|NCT00583362|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||grams per liter||Standard Deviation|Mean
2791389|NCT00582998|Primary|Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)|Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy|The time from injury from surgical stabilization (14 days)|The numbers reflected in the Participant Flow, Baseline Characteristics, and Adverse Events sections reflect participants and not fractures.|||Fractures|Fractures||Count of Units
2791365|NCT00583362|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Percentage of blood by volume||Standard Deviation|Mean
2791366|NCT00583362|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||10^12 per liter||Standard Deviation|Mean
2791367|NCT00583362|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||10^9 per liter||Standard Deviation|Mean
2791368|NCT00583362|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Seconds||Standard Deviation|Mean
2791369|NCT00583362|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).|Approximately up to 13 years|MITT population|||Events per 100 participant years|||Number
2791370|NCT00583362|Primary|Adverse Event (AE) Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).|Approximately up to 13 years|MITT Population|||Events per 100 participant years|||Number
2791371|NCT00583362|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.|Approximately up to 13 years|MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|||Participants|||Number
2791372|NCT00583219|Secondary|Incontinence Impact Questionnaire-short Form (IIQ-7) Scores|The IIQ-7 was one measure of urinary-associated quality of life. The IIQ-7 questionnaire has 7 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 21, a higher score indicating greater distress.|baseline, 1 month, 3 months||||units on a scale||Inter-Quartile Range|Median
2791373|NCT00583219|Secondary|Bothersomeness|The bothersomeness refers to the question: On a scale of 1-10 (0 is not at all; 10 is intolerable), how badly does loss of urinary control bother you?|baseline, 1 month, 3 months||||units on a scale||Inter-Quartile Range|Median
2791507|NCT00581776|Secondary|3 Year Progression Free Survival|This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.|36 months||||percent of participants||95% Confidence Interval|Number
2791375|NCT00583219|Secondary|Urinary Urgency at 3 Months|"Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."|3 months after treatment||||participants (per category)|||Number
2791376|NCT00583219|Secondary|Urinary Urgency at 1 Month|"Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."|1 month after treatment||||participants (per category)|||Number
2791377|NCT00583219|Secondary|Urinary Urgency at Baseline|"Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."|baseline||||participants (per category)|||Number
2791378|NCT00583219|Secondary|Urine Culture||baseline, 1 month, 3 months||||participants|||Number
2791379|NCT00583219|Secondary|Postvoid Residual||baseline, 1 month, 3 months||||mL||Inter-Quartile Range|Median
2791380|NCT00583219|Secondary|Mean Number of Pads Per Day||baseline, 1 month, 3 months||||pads per day||Inter-Quartile Range|Mean
2791381|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|3 months after treatment||||participants (per category)|||Number
2791382|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 1 Month|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|1 month after treatment||||participants (per category)|||Number
2791383|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at Baseline|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline||||participants (per category)|||Number
2791384|NCT00583219|Secondary|Median 24 Hour Pad Weight|Prior to baseline and follow-up visits, the study coordinator weighed standard pads provided to the subject for the study time period. The study coordinator instructed the subject to bring in any pads used during the 24-hour period prior to baseline and follow up visits. The study coordinator recorded the 24-hour pad weights into the study dataset.|baseline, 1 month, 3 months||||g||Inter-Quartile Range|Median
2791385|NCT00583219|Primary|Median Number of Incontinent Episodes During 24 Hours|The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.|baseline, 1 month, 3 months||||number of incontinent episodes||Inter-Quartile Range|Median
2791386|NCT00583115|Secondary|1) Decrease in Pulmonary Artery Pressures and Vascular Resistance as Determined by Cardiac Catheterization, 2) Time to Clinical Worsening,3) Survival.||6 months|The only participant died prior to study completion. Unable to measure pulmonary artery pressure and vascular resistance as only participant died prior to study completion. Unable to measure time to clinical worsening as only participant died. Survival should be counted as 0.||||||
2791387|NCT00583115|Primary|1) Safety and Tolerability as Determined by Laboratory Evaluation, Physical Examination, Echocardiographic Analysis, and Adverse Events, and 2) Efficacy as Determined by an Increase in the Non-encouraged 6 Minute Walk Test From Baseline.||6 months|Unable to measure safety and tolerability as the participant died prior to study completion. Laboratory evaluations not able to be measured as participant died. Physical examination, Echocardiographic and adverse events not able to be measured as participant died Unable to measure 6 minute walk test as participant died prior to study completion.||||||
2791388|NCT00583102|Primary|Complete Remission Rate|"The primary study end point will be complete remission rate.~Complete Remission (CR):~Complete remission is defined as the presence of all of the following:~Peripheral Blood Counts (sustained > 30 days)~Absolute neutrophil count ³1500/ml.~Platelet count ³100,000/ml.~No leukemic blasts in the peripheral blood.~Transfusion independent for red cells and platelets. Bone Marrow~Cellularity >20% with maturation of all cell lines.~No Auer rods.~<5% blast cells. No extramedullary leukemia (such as CNS or soft tissue involvement). OR Complete Response with Incomplete Platelet Recovery (CRp): CRp satisfies all CR criteria except platelets < 100,000/µL.~Partial Remission (PR):~Must meet all criteria of a CR except that the bone marrow may contain 5-24% blasts.~Treatment Failure:~Failure to achieve a CR."|5 weeks|7 patients out of the 20 who completed the trial were primary refractory AML, so as per protocol these patients were not included for assessment and the early stopping rule.|||Participants|||Count of Participants
2791390|NCT00582972|Secondary|Change in Bone Resorption From Baseline to 1 Month|urine n-telopeptide (normalized to creatinine levels)|change in bone resorption from baseline to 1 month|23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits|||mcg/mmol creatinine||Standard Deviation|Mean
2791391|NCT00582972|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent calcium absorption|change in calcium absorption from baseline to 1 month|Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.|||percent calcium absorption||Standard Deviation|Mean
2791392|NCT00582946|Primary|Maximum Effective Sound Pressure Level (MEPO)|A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.|1 month||||decibels (dB) Sound Pressure Level (SPL)||Standard Deviation|Mean
2791393|NCT00582933|Primary|Death From GVHD|To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD.|2 years||||participants|||Number
2791394|NCT00582907|Secondary|To Determine the Differences in the Proportion of Time Subjects Received Rilonacept vs Placebo|"The proportion of time within the trial that participants received rilonacept as opposed to placebo. The reason for this outcome is that participants who had at least 2 attacks within an individual treatment course were able to escape in a blinded manner to the other treatment arm until the end of that treatment course and then resume the original randomization sequence. Thus participants may have been treated for a longer time with one treatment arm or the other."|12 months|Participants who received at least one treatment course of both rilonacept and placebo.|||Percentage of time treated||95% Confidence Interval|Number
2791395|NCT00582907|Secondary|To Determine the Differences in the FMF Severity Score of the Subjects Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the Armenian Evaluation Score between rilonacept and placebo courses. The Armenian Evaluation Score is a composite score of disease severity based on the frequency, duration and character of attacks (degree of fever and severity of serositis). It was adapted to calculate a score for a 3-month treatment course. The lowest (best) score is 0 and higher values are worse. In theory there is no upper limit to the scale. The total score is reported (there are no subscales).|overall 12 months|Participants who received at least one course each of placebo and rilonacept.|||units on a scale||Inter-Quartile Range|Median
2791396|NCT00582907|Secondary|To Determine the Differences in the Quality of Life Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the health-related quality of life (HRQOL) during treatment with rilonacept vs. placebo. HRQOl was measured by the Childhood Health Questionnaire which was adopted also for adults. There are 2 summary scores: 1. Physical summary score. 2. Psychosocial summary score. The data reported below in the upper table is the physical summary composite score and in the lower table the psychosocial summary composite score. Scores were from 0-100 (higher is better) with a score of 50 representing the mean of the normal population.|12 months|Participants who received at least one treatment course of rilonacept and placebo.|||Composite HRQOL summary score||Inter-Quartile Range|Median
2791397|NCT00582907|Secondary|To Determine the Differences in Serum Amyloid A Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in serum amyloid A levels (mg/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo|||mg/L||Inter-Quartile Range|Median
2791398|NCT00582907|Secondary|To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The differences between treatment arms in the fibrinogen level (micromol/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo|||micromol/L||Inter-Quartile Range|Median
2791399|NCT00582907|Secondary|To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in the platelet count X 10 to the power of 9|3 months (each treatment course, overall 12 months)|The number of patients who received at least one course each of rilonacept and placebo|||cell count X10 to the power of 9||Inter-Quartile Range|Median
2791400|NCT00582907|Secondary|To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo)|Differences between the treatment courses in the C-Reactive Protein levels mg/L|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo|||mg/L||Inter-Quartile Range|Median
2791401|NCT00582907|Secondary|To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo).|Erythrocyte sedimentation rate - ESR (mm/h)|3 months (each treatment course, overall 12 months)|Participants who completed at least one treatment course of both rilonacept and placebo.|||mm/h||Inter-Quartile Range|Median
2791402|NCT00582907|Secondary|To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo).|In a survival analysis we measured the difference (in days) until the development of the first and second attack within a treatment course of up to 3 months and examined differences in this parameter between rilonacept and placebo. Data regarding the development of the second attack are reported below. In regards to the first attack there were no significant differences between rilonacept and placebo (20 days (7.5,>90)for rilonacept; 15 (8,32) for placebo, P=0.066).|3 months|All participants who received an intervention and developed an attack were analyzed.|||days until second attack||Inter-Quartile Range|Median
2791403|NCT00582907|Secondary|To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses.|Differences between rilonacept and placebo in the percentage of courses that attained at least a 50% decrease in FMF attacks when compared to attacks in the screening period.|Up to 3 months for each treatment course|Participants who completed at least one complete treatment course.|||Percentage of courses|||Number
2791521|NCT00581542|Primary|Number of Participants With Normal Physical Examination of the Eye||10 days||||participants|||Number
2791404|NCT00582907|Secondary|Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses.|The percentage of rilonacept and placebo treatment courses without FMF attacks.|Each treatment course of up to 3 months|Participants who at least one complete treatment course.|||Percentage of courses|||Number
2791405|NCT00582907|Secondary|To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo.|This outcome was the difference in days in the length of attacks between rilonacept and placebo.|12 months|Participants who received any treatment and had recorded attacks|||Number of days||95% Confidence Interval|Median
2791406|NCT00582907|Primary|To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo.|Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections.|12 months of entire study length|Safety analysis included all participants who received at least one dose of medication.|||AEs per patient-month of treatment||Inter-Quartile Range|Median
2791407|NCT00582907|Primary|To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks.|Difference in number of attacks per treatment month between rilonacept and placebo|attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)|Patients who received at least one complete treatment course and reported attacks were analyzed for the primary outcome measure.|||number of attacks per month||Inter-Quartile Range|Median
2791408|NCT00582894|Secondary|Number of Participants Overall Survival as a Function of Time.||100 days post transplant|Last observation carried forward|||Participants|||Number
2791409|NCT00582894|Primary|Number of Participants Experiencing Engraftment Donor Chimerism (EDC)||At time of study termination||||Participants|||Number
2791410|NCT00582894|Secondary|Number of Participants Relapse-Free||100 days post-transplant|Last observation carried forward|||Participants|||Number
2791411|NCT00582894|Primary|Number of Participants Experiencing Transplant Related Mortality (TRM)||At Day 100 post trans-plant||||Participants|||Number
2791412|NCT00582816|Secondary|Analysis of NK Cell KIR Expression Over Time|NK cell KIR expression over time will be examined. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Up to 12 months|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.||||||
2791413|NCT00582816|Secondary|Association Between Parental KIR Genotypes and NK Cell Cytotoxicities|NK cells express killer-cell immunoglobulin-like receptors (KIR) and have cytotoxic activity. The association between NK cell cytotoxicity over time and KIR genotypes will be examined. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Day 60|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.||||||
2791414|NCT00582816|Secondary|NK Expression Levels|Natural Killer (NK) cell expression levels will be explored. Blood samples will be collected at months 1, 2, 3, 6, 9, and 12.|Up to 12 months|Blood samples were not collected uniformly as many patients developed GVHD, requiring treatment with steroids. Once steroids were initiated the results of this testing became uninterpretable. No data was collected towards this outcome measure.||||||
2791415|NCT00582816|Primary|Mortality Rate|Mortality rate at 100 days post-transplant.|100 days post-transplant|Death Prior to Day +100|||participants|||Number
2791416|NCT00582816|Primary|Number of Days Until Engraftment Criteria Were Met|"Utilize non-myeloablative conditioning regimen in the haploidentical transplant setting. Engraftment is defined as achieving an absolute neutrophil count ≥ 500 by 28 days post-transplant; platelets and red blood cells will also be measured up to 28 days:~Neutrophils: ≥500/uL for 3 days~Platelets: ≥20 K/uL for 3 days without transfusion~Red blood cells: the date of the last RBC transfusion after achieving transfusion independence Results are reported as number of days until engraftment criteria was met, per neutrophil, platelet and red blood cell measurements, above."|28 days||||days||Full Range|Median
2791417|NCT00582816|Primary|Engraftment Failure|"Utilize non-myeloablative conditioning regimen in the haploidentical transplant setting.~Primary engraftment failure: failure to achieve ANC of ≥500/uL prior to day +28 Late engraftment failure: Initial engraftment achieved with ANC ≥500/uL by day +28 followed by loss of graft Autologous Cells Infused: achieved hematologic recovery following infusions of autologous stem cells Second Haploidentical Transplant: re-transplantation utilizing an alternative haploidentical donor"|28 days||||participants|||Number
2791418|NCT00582816|Primary|Grade III or IV GVHD|"Skin Grade III: Stage 0-4 GVHD, where 0 is no rash and 4 is generalized erythroderma with bullous formation and/or with desquamation Grade IV: Stage 4 GVHD, generalized erythroderma with bullous formation and/or with desquamation~GI (diarrhea) Grade III: Stage 2-4 GVHD, where 2 is > 1000 mL/day but ≤ 1500 mL/day or 556-833 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena Grade IV: Stage 0-4 GVHD, where 0 is < 500 mL/day or 280 mL/m2, and 4 is severe abdominal pain +/- ileus or stool with frank blood or melena~Overall:~Grade III: Grade III Skin and/or GI as well as bilirubin 3.1-15 mg/dl Grade IV: Grade IV Skin and/or GI as well as bilirubin > 15 mg/dl"|Day 100||||participants|||Number
2791419|NCT00582790|Secondary|Number of Participants With Immunologic Responses|Blood was collected to analyze T-cell populations from all patients prior to treatment on day 1 of cycles 1 and 2, and days 4 and 8 of cycles 1 and 2. Changes in gamma delta T-cell population and CD3 T-cell populations were reported.|baseline to cycle 2 day 8|One patient did not receive study treatment and so was not included in the analysis.|||participants|||Number
2791420|NCT00582790|Secondary|Number of Participants With Toxicities|Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events.|Baseline to 30 days after last dose of study treatment|Patients who received at least one dose of study medication. One of the 12 patients never received study medication so only 11 were evaluable for toxicity|||participants|||Number
2791750|NCT00579670|Secondary|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"||Week 12|FAS|||Participants|||Number
2791421|NCT00582790|Secondary|Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks|All 12 patients were followed for survival until death. 8 participants who received more than one cycle of treatment and who were considered evaluable for response were followed until time to progression. Disease progression was determined by CT scans of the chest/abdomen/pelvis obtained every 2 cycles and based on RECIST version 1.0. Progression is defined using RECIST (V1.0) at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Time frame is from study entry until time to disease progression and time to death, up to 50 months|8 of the 12 participants who received more than 1 cycle of therapy and were considered evaluable for time to progression. All 12 were evaluated for survival|||participants|||Number
2791422|NCT00582790|Primary|Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid|Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|CT scans obtained at baseline, then every 2 cycles|Anti tumor response was measured in those patients who completed at least 1 cycle of study treatment 4 subjects did not complete 1 cycle of treatment.|||participants|||Number
2791423|NCT00582738|Secondary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at 12 and 24 Months Post Randomization|End of Study (EOS) endpoint is the last available assessment on or after Month 12. A reduction of at least two logs in HCV RNA viral load was considered as success|baseline, 12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. If 12-month HCV was the last available assessment, this value is used to impute the End of Study value.|||log10 copies/ml||Standard Deviation|Mean
2791424|NCT00582738|Secondary|Percentage of Patients in Each Study Arm With Increase of ≥1 Point in the Ishak-Knodell Staging Score in Fibrosis|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite.|baseline to month 24|Difference Ishak-Knodell Score at End-of-Study The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication|||percentage of participants|||Number
2791425|NCT00582738|Secondary|Comparison of the Effect of Both Regimens on the Inflammatory (Acti-test) and Fibrosis (Fibro-test) Components of Fibrosure, and on Fibrosis Area Assessed by Histomorphometry|"The Fibrosure test is the combination of Fibro-test + Acti-test.~FibroTest (FT) was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase (GGT). FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis.~Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase (ALT). ActiTest (AT) was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis~If 12-month Actitest value was the last available assessment, the value is used to impute the final staging score(End of Study)"|baseline, 12 and 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||units on a scale||Full Range|Median
2791426|NCT00582738|Secondary|Comparison of the Effect of Both Regimens in the Necroinflammatory Grading Score (Ishak-Knodell) (Portal Inflammation)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite|baseline, 12 months, 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||Score on a scale||Standard Deviation|Mean
2791427|NCT00582738|Secondary|Comparison of Renal Function (Glomerular Filtration Rate [GFR] Calculated Using the Modification of Diet in Renal Disease Study Group [MDRD] Formula) Between Study Groups|"GFR Month 9 value if available, otherwise minimal first year post-randomization available value. Imputation rule of missing Month 24 GFR values: GFR Month 18 value if available, otherwise Month 12 GFR is used.~Least square means are from an ANCOVA model containing treatment as factor and baseline eGFR as a covariate."|12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||mL/min/1.73^2||Standard Error|Least Squares Mean
2791428|NCT00582738|Secondary|Number of Patients With Events (Progression to Cirrhosis, Retransplantation, HCV Related Death, First BPAR, Graft Loss)at 12 and 24 Months||12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.|||participants|||Number
2791429|NCT00582738|Secondary|Percentage of Patients With Death, Graft Loss and Biopsy Proven Acute Rejection (BPAR) Between Study Groups||24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication.|||Percentage of Participants|||Number
2791724|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791430|NCT00582738|Secondary|Change From Baseline in Fibrosis Metavir Scoring at 12 and 24 Months Post Randomization|Metavir Score: F0=No fibrosis; F1=Portal fibrosis without septa; F2=Portal fibrosis with rare septa; F3=Numerous septa without cirrhosis Decrease in score from baseline indicates improvement|Baseline, 12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Only participants with observations at baseline and specified timepoints were included in the analysis.|||Scores on a Scale||Full Range|Median
2791431|NCT00582738|Primary|Change From Baseline in Fibrosis Staging Score (Measured by the Ishak-Knodell Staging Score) Between Baseline and 24 Months Post-transplant.|"Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite~Decrease in score from baseline indicates improvement"|baseline, 24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Small number of biopsies obtained at Month 24 due to study being prematurely terminated.|||Score on Scale||Full Range|Median
2791432|NCT00582712|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)||1 year|No data was ever analyzed, resulted, or published on this study.||||||
2791433|NCT00582660|Primary|Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot|At 72 hours after start of treatment, the number of subjects with immunoblot demonstrated a 1.5 to 2 fold increase in 15-LOX-1 protein expression in human colorectal adenocarcinoma cell line with epithelial morphology(HT-29) and dihydrolipoamide dehydrogenase(DLD)-1 cells.|baseline to 72 hours||||Participants|||Number
2791434|NCT00582660|Primary|Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib|"The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 7 days post baseline. Cox-2 activity is measured by assessing tumors and normal tissue using Electron microscope and Tandem mass Spectrometry methodology though the UAB shared Mass Spectrometry facility. Improvement was measured by 2-fold increase in COX-2 activity from baseline. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin."|baseline to 7 days||||Participant|||Number
2791435|NCT00582608|Primary|Safety and Toxicity is Measured by the Total Number of Participants Affected|Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.|2 years||||Participants|||Count of Participants
2791436|NCT00582556|Secondary|Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy|"PSA response was measured by observing the serum PSA one week after beginning zoledronic acid and prior to beginning androgen deprivation therapy.~Arm 2 and Arm 3 were not able to be assessed for this endpoint as all subjects were on androgen deprivation prior to receiving zoledronic acid."|2 Years||||participants|||Number
2791437|NCT00582556|Secondary|Number of Subjects Had a Significant Change in Immune Markers.|Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.|2 Years||||participants|||Number
2791438|NCT00582556|Secondary|The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.|Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.|2 years||||participants|||Number
2791439|NCT00582556|Primary|The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.|Effects on bone mineral density were measured at four locations at six month intervals for 24 months.|2 years||||participants|||Number
2791440|NCT00582517|Primary|Knee Stability|The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.|12 months||||participants|||Number
2791441|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 3 Weeks|The number of participants who completed the study were analyzed.|||Millimeters||Standard Deviation|Mean
2791442|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 2 Weeks|The number of participants who completed the study were analyzed.|||Millimeters||Standard Deviation|Mean
2791443|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 3 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
2791444|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 2 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
2791445|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 1 Week|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
2791446|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 3 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
2791447|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 2 Weeks|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
2791448|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 1 Week|The number of participants who completed the study were analyzed.|||Millimeters||Standard Deviation|Mean
2791449|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 1 Week|The number of participants who completed the study were analyzed|||Minutes||Standard Deviation|Mean
2791450|NCT00582426|Secondary|Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)|Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.|Baseline to Day 168|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.|||Units on a scale||Standard Deviation|Mean
2791451|NCT00582426|Secondary|Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)|Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.|Day 56, Day 84, Day 112, Day 140, Day 168|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. N in each category indicates the number of patients analyzed with observations at that timepoint."|||Percentage of Participants||95% Confidence Interval|Number
2791452|NCT00582426|Secondary|Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of Participants||95% Confidence Interval|Number
2791453|NCT00582426|Secondary|Percentage of Patients Hospitalized Due to Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of patients|||Number
2791454|NCT00582426|Secondary|Percentage of Participants Who Need Opioids for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of Participants||95% Confidence Interval|Number
2791455|NCT00582426|Secondary|Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea|For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1.|||Percentage of participants||95% Confidence Interval|Number
2791504|NCT00581854|Primary|Complete Response Rate to Induction Therapy|Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).|Median follow up of 37 months|All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled.|||percentage of participants||90% Confidence Interval|Number
2791456|NCT00582426|Secondary|Percentage of Episodes by Grade|Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.|||Percentage of Episodes|Participants||Number
2791457|NCT00582426|Secondary|Percentage of Patients by Grade of Diarrhea|Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.|||Percentage of Participants|||Number
2791458|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient by Cycle|Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)|at each cycle (28 days per cycle)|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. n indicates patients with observations during each cycle."|||Episodes/patient/cycle||Standard Deviation|Mean
2791459|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient|Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.|||Episodes/patients/day||Standard Deviation|Mean
2791460|NCT00582426|Primary|Percentage of Participants Developing Diarrhea (Grade 1 to 4)|The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 month overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."|||Percentage of Participants||95% Confidence Interval|Number
2791461|NCT00582400|Secondary|Progression Free Survival|Time to progression from start of treatment|6 years|1 evaluable participant lost to follow up. No data collected.||||||
2791462|NCT00582400|Secondary|Duration of Response.|Time to progression.|6 years|Participants with response|||months||Full Range|Median
2791463|NCT00582400|Primary|Number of Patients With Response to Treatment (RECIST Criteria)|Response included complete response, partial response or stable disease.|6 years|Participants who were evaluable for response|||participants|||Number
2791464|NCT00582400|Primary|Number of Participants With Treatment Related Toxicity.||6 years||||participants|||Number
2791465|NCT00582361|Primary|Infections|Number of acute, delayed and deep wound infections.|Up to 12 months||||Number of infections|||Number
2791466|NCT00582361|Primary|Healing of Orthopaedic Trauma Open Fractures|Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)|from surgery to wound closure||||use days||Full Range|Mean
2791467|NCT00582309|Primary|Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.|The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG < 120, and maintaining the target range thereafter.|24 hours||||Time to reach glycemic control in hours||Standard Deviation|Mean
2791468|NCT00582205|Secondary|Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity||3 years||||Participants|||Count of Participants
2791469|NCT00582205|Primary|Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.||3 years||||Participants|||Count of Participants
2791470|NCT00582166|Secondary|Overall Survival (OS)|To estimate overall survival, 95% confidence intervals will be used.|At 12 months||||percentage of participants||95% Confidence Interval|Median
2791471|NCT00582166|Secondary|Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0|To record the toxicities associated with this regimen.|Up to 5 years and 9.5 months||||Participants|||Count of Participants
2791472|NCT00582166|Secondary|Response Rates|To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a > 1.5cm residual node that has decreased by >75%, and/or individual nodes that were previously confluent that have decreased by >75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).|Up to 5 years and 9.5 months||||percentage of participants||95% Confidence Interval|Median
2791505|NCT00581828|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent and true fractional calcium absorption|1 month|One subject's urine sample was mishandled, leaving 18 subjects with complete data for analysis.|||percent calcium absorption||Standard Deviation|Mean
2791473|NCT00582166|Secondary|24-month Progression Free Survival (PFS)|"Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months.~Progression is defined as any of the following:~- Appearances of any new lesions/sites during or after therapy.~Increase of >/= 50% in the SPD (sum of perpendicular diameter) from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site.~Increase by > 50% in greatest diameter from nadir measurement of any previously involved dominant node > 1.0 cm in its short axis."|Up to 24 months||||Participants|||Count of Participants
2791474|NCT00582166|Primary|Median Progression Free Survival (PFS)|Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).|up to 5 years, 9.5 months, from first day on treatment to last follow up|The study was stopped prematurely, subjects were not followed for a full 7 years. We have data for 16 subjects, 6 experienced a progression event, 10 survived progression-free through last follow-up. Date of last follow-up is used to calculate progression-free survival for those who did not experience progression.|||months||80% Confidence Interval|Median
2791475|NCT00582114|Other Pre-specified|Serious Adverse Events and Cardiovascular Events That Led to Trial Termination|Cardiovascular events were counted by subject and included the following: myocardial infarction (MI), stroke, hospitalization for congestive heart failure (CHF), hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. Adverse events reported are those during the course of 12 months of participation in the trial. All serious adverse events were adjudicated by R.A. and A.D.S. who were masked to the drug assignment at the time of adjudication. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. The cardiovascular event rate was calculated by treatment group assignment. Incidence rate ratio (IRR) by treatment was then determined along with the 95% confidence intervals (95% CIs). As a post hoc analysis, we also determined the narrower definition of cardiovascular events per group that included MI, stroke, CHF, or cardiovascular death.|1 yr||||events/100 patient-years|||Number
2791476|NCT00582114|Primary|The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.|Baseline, 6 months, 12 months|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. The analysis was performed by intention to treat, if the patient received at least one dose of the randomized drug regardless of the availability of a post-baseline echocardiogram.|||g/m^2||Standard Deviation|Mean
2791477|NCT00582075|Secondary|Overall Survival||2 years||||weeks||Full Range|Median
2791478|NCT00582075|Primary|Percentage of Participants With Distant Brain Failure (DBF) at One Year|Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.|1 years||||percentage of participants|||Number
2791479|NCT00582036|Primary|Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)||100 days|Due to early termination, data not analyzed|||Participants|||Number
2791480|NCT00582036|Secondary|Reduced Length of In-hospital Stay||About 100 days|||||||
2791481|NCT00582036|Secondary|Reduction of Infection||About 100 days|||||||
2791482|NCT00582010|Primary|Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery|Number of any complication reported by subjects at 9 months after surgery|baseline to 9 months post surgery||||complications|||Number
2791483|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)|Number of complications due to hepatobiliary events.|baseline to 9 months after transplantation||||Complications|||Number
2791484|NCT00582010|Secondary|Effect of iNO on SICU Stay|Number of minutes after surgery subject remained in SICU|baseline to discharge for SICU||||minutes||Inter-Quartile Range|Mean
2791485|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)|A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline||||percent change from baseline||Standard Deviation|Mean
2791486|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))|The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
2791487|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)|The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease.|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
2791488|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)|The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline).|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
2791489|NCT00582010|Secondary|Effect of iNO on Hosptial Length of Stay|number of days subject in hospital after surgery until discharge|from surgery through discharge from hospital||||days||Inter-Quartile Range|Mean
2791506|NCT00581776|Secondary|3 Year Overall Survival (OS)|This is the percent of participants who were still alive at 3 years after study entry.|36 months||||Percent of participants||95% Confidence Interval|Number
2791490|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)|The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline).|baseline and 96 hours after baseline||||percentage change from baseline||Standard Deviation|Mean
2791491|NCT00581971|Primary|Response as Evaluated by Recurrence of Diseases|Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.|2 years from end of treatment (Radiation therapy)||||Participants|||Number
2791492|NCT00581971|Primary|Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.|Particpants experiencing Acute Toxicities > Grade 3|2 years from radiation therapy||||participants|||Number
2791493|NCT00581945|Primary|Change From Baseline in Forced Expiratory Flow 25% to 75%|The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population|||L/sec||Standard Deviation|Mean
2791494|NCT00581945|Primary|Change From Baseline in Slow Vital Capacity (SVC)|Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population|||liters||Standard Deviation|Mean
2791495|NCT00581945|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population|||liters||Standard Deviation|Mean
2791496|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted|"The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function."|Baseline, Week 25 and Week 45|Safety population|||Percent of predicted||Standard Deviation|Mean
2791497|NCT00581945|Secondary|Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events|Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.|Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.|The safety population consisted of all randomized patients who received at least one dose of the study drug.|||Participants|||Number
2791498|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|Baseline, Week 25 and Week 45|The safety population consisted of all randomized patients who received at least one dose of the study drug.|||Liters||Standard Deviation|Mean
2791499|NCT00581919|Secondary|Progression-free Survival|Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.||||months||Full Range|Median
2791500|NCT00581919|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed up to 7 years||||months||Full Range|Median
2791501|NCT00581919|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR|"Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.~Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.~Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis."|Every 21 days, up to 24 weeks||||percentage of participants||90% Confidence Interval|Number
2791502|NCT00581867|Secondary|Global Cognition|Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.|90 mins||||z-scores||Standard Deviation|Mean
2791503|NCT00581867|Primary|fMRI Measure of Hippocampal Activation|Percentage active voxels of total hippocampal volume of interest|30 minutes After Intervention Administration||||percentage of active voxels||Standard Deviation|Mean
2791508|NCT00581776|Primary|Complete Response Rate (CR) at the End of Induction Chemotherapy|Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.|at 21 weeks||||percent of participants||95% Confidence Interval|Number
2791509|NCT00581776|Primary|Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).|"Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.~1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses."|At completion of induction therapy (21 weeks)||||Percent of participants||95% Confidence Interval|Number
2791510|NCT00581581|Primary|WeeFIM Score|"WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from 1 for total assistance, total dependence, maximal prompting, or not testable to 7 for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response."|7-8 years after initial intervention||||percentage of participants|||Number
2791511|NCT00581555|Secondary|Percentage of Rebound Effects|Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.|Baseline to Week 24.|ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2791512|NCT00581555|Secondary|DLQI at Each Visit From Baseline|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data|||scores on a scale||Standard Error|Mean
2791513|NCT00581555|Secondary|Change From Randomization in DLQI to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||scores on a scale||95% Confidence Interval|Mean
2791514|NCT00581555|Secondary|Percent (%) Change of PASI Score From Randomization to Week 24|Percent improvement in PASI score was calculated from Week 6 to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2791515|NCT00581555|Primary|Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)|PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.|Randomization to Week 24.|Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||scores on a scale||95% Confidence Interval|Mean
2791516|NCT00581555|Secondary|Probability of Being Relapse Free During the 24 Weeks After Randomization|Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||probability of relapse free|||Number
2791517|NCT00581555|Secondary|Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization|Relapse was defined as the loss of 50% improvement in PASI.|Randomization to Week 24.|ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||Percentage of participants|||Number
2791518|NCT00581555|Secondary|Change From Randomization in PGA Score to Week 24|PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.|||scores on a scale||95% Confidence Interval|Mean
2791519|NCT00581555|Secondary|PASI Area Under the Curve (AUC) Between Randomization and Week 24|PASI AUC = Area under the curve from randomization (Week 6) to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data.|||scores on a scale * weeks||Standard Error|Mean
2791520|NCT00581542|Secondary|Number of Participants With a Negative Bacterial Culture|Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.|10 days|Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group.|||participants|||Number
2791522|NCT00581529|Secondary|Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis|One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis.|||Percentage of reference volume||Full Range|Mean
2791523|NCT00581529|Secondary|Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods|Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.|not specific|At the time the study was written, we planned to compare treatment methods. Over the course of the study, it was determined additional analysis was not needed due to the analysis and publication of this outcome by several other investigators.||||||
2791524|NCT00581529|Primary|Percentage of Participants That Experience Cosmetic Adverse Events (AEs)|The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis. 2 additional patients underwent mastectomies and were therefore excluded from analysis (cosmesis could not be assessed at 5 years). 30 patients were analyzed.|||percentage of participants|||Number
2791525|NCT00581529|Primary|Rate of Local Control at 5 Years|The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.|5 years|34 for patients were enrolled and treated.|||percentage of participants|||Number
2791526|NCT00581399|Secondary|Duration of Mediastinal Drainage|The outcome to measure is the duration of the chest tubes inserted in the patient in hours. The time starts at the time the chest is completely closed and the end time when the chest tubes are pulled out of the patient's chest.|Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient||||Hours||Standard Deviation|Mean
2791527|NCT00581399|Primary|Amount of Postoperative Bleeding|The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.|24-48 hours post surgery||||mL||Standard Deviation|Mean
2791528|NCT00581386|Primary|Number of Failed Cases|We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.|Time taken for successful intubation|As per protocol, a case is decided as a failed case when the patient was not able to be intubated with the assigned device after 3 attempts.|||Participants|||Number
2791529|NCT00581386|Primary|Post Operative Morbidity|We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.|2 hrs and 24 hrs after surgery|As per protocol,all the patients were followed up at 2 hrs and 24hrs to check for any postoperative hoarseness, sorethroat and difficulty swallowing. The numbers represent the number of patients who complained of postoperative morbidity.|||participants|||Number
2791530|NCT00581386|Primary|Leak Pressures|The maximum leak pressure attained for each device.|Duration of surgery||||cm of H2O||Standard Deviation|Mean
2791531|NCT00581386|Primary|Number of Patients Who Required Multiple Attempts.|The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.|Time taken for intubation|As per protocol,the number of cases in whom the device could not be placed successfully in first attempt and required 2nd and 3rd attempts.|||Participants|||Number
2791532|NCT00581386|Primary|Number of Participants With a Successful First Attempt Placement|The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.|Time taken for successful placement|As per protocol,of all the patients intubated with the assigned specific device number of patients in whom the device was placed successfully in the first attempt.|||Participants|||Number
2791533|NCT00581386|Primary|Duration of Intubation|The time taken to successfully place the device in seconds.|duration of intubation||||seconds||Standard Deviation|Mean
2791534|NCT00581360|Secondary|Median Duration of Stable Disease Response|Median number of months of Stable Disease Response Per RECIST v1.0 (Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 36 months||||months||Full Range|Median
2791535|NCT00581360|Secondary|Number of Months of Survival|Number of months that the participant was alive.|Up to 5 years||||months|||Number
2791536|NCT00581360|Secondary|Number of Months of Progression-free Survival (PFS)|Number of months that participants experienced stable disease (the disease does not progress per RECIST v1.0 criteria - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 5 years||||months|||Number
2791537|NCT00581360|Primary|Stable Disease Rate|Using RECIST v1.0 criteria, stable disease rate is the number participants experiencing stable disease (SD) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD).|Up to 5 years|All patients in this population had stable disease as best response.|||percentage of participants|||Number
2791725|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791538|NCT00581360|Primary|Objective Response Rate (ORR)|ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s|Up to 5 years||||percentage of participants|||Number
2791539|NCT00581347|Secondary|Receipt of a Well Child Visit Within a 12 Month Period|We compared the number of participants in the intervention group who received a well child visit within a 12 month period versus those in the control group.|1 year||||participants|||Number
2791540|NCT00581347|Primary|Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)|We compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.|15 months||||participants|||Number
2791541|NCT00581308|Primary|Safety|A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure.|5 years||||Participants|||Count of Participants
2791542|NCT00581308|Primary|Efficacy|"A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.~Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:~Any major device/procedure adverse event~Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.~Clinically significant leak at the follow-up visit"|60 months|Subjects with Successful Device Delivery|||Participants|||Number
2791543|NCT00581308|Primary|Efficacy|"A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.~Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:~Any major device/procedure adverse event~Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.~Clinically significant leak at the follow-up visit"|36 months|Subjects with Successful Device Delivery|||Participants|||Number
2791544|NCT00581308|Primary|Efficacy|"A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:~Any major device/procedure adverse event~Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.~Clinically significant leak at the follow-up visit"|12 months|Subjects with Successful Device Delivery|||Participants|||Number
2791545|NCT00581256|Secondary|The Number of Participants That Experience Pericarditis and Pneumonitis|"To compare rates of pericarditis and pneumonitis by treatment arm.~Pericarditis (inflammation of the pericardium):~Grade1: Asymptomatic, ECG or physical exam; changes consistent with pericarditis Grade 2: Symptomatic pericarditis Grade 3: Pericarditis with physiologic consequences Grade 4: Life-threatening Pneumonitis (inflammation of the walls of the alveoli in the lungs) Grade 1: Asymptomatic, radiographic findings only Grade 2: Symptomatic, not interfering with ADL (activities of daily living) Grade 3: Symptomatic, interfering with ADL Grade 4: Life-threatening"|approx 1 year||||participants|||Number
2791546|NCT00581256|Secondary|Number of Participants With New Lung Perfusion Defects|To compare changes in lung perfusion defects by treatment arm. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution's normal polar map databases for the left anterior descending artery (LAD).|baseline to approx 1 year|One patient randomized to the IMRT arm did not receive her post-RT lung SPECT scan therefore pre- and post-radiotherapy Lung SPECT scans were available for 53 patients.|||participants|||Number
2791547|NCT00581256|Secondary|Mean Percent Change in Ejection Fraction (LVEF)|To compare change in ejection fraction between treatment arms.|baseline to approx 1 year||||percent change||Full Range|Mean
2791548|NCT00581256|Primary|The Number of Participants With a Significant Increase in Perfusion Defects (PD)|To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution's normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of interest variability, a PD increase greater than 5% or 10% was considered significant for 2.5- and 1.5-SD thresholds, respectively.|1 Year||||participants|||Number
2791549|NCT00581230|Primary|Glottic View as Assessed by the Cormack and Lehane Classification|Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible|before intubation||||participants|||Number
2791550|NCT00581230|Primary|Ease of Mask Ventilation as Assessed by Han Class|Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant|Time before intubation||||participants|||Number
2791551|NCT00581113|Primary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Brain metastases bi-dimensional area|12 months post RT|Not enough patients were enrolled to allow for any meaningful analysis.||||||
2791552|NCT00581113|Secondary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Increase in the bi-dimensional tumor area for any of the tracked brain metastases or the appearance of any new brain metastases on a follow-up MRI.|12 months after end of radiation therapy|Study terminated early due to poor accrual||||||
2791553|NCT00581100|Secondary|Change From Baseline in Physician Fingernail Grading Assessment Total Score|Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791554|NCT00581100|Secondary|Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791555|NCT00581100|Secondary|Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791556|NCT00581100|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI)|Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791557|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791558|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791559|NCT00581100|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||unts on a scale||95% Confidence Interval|Mean
2791560|NCT00581100|Secondary|Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791561|NCT00581100|Secondary|Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791562|NCT00581100|Secondary|Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791577|NCT00580983|Primary|Percentage of Participants With Grade 0-1 Observer-rated Dysphagia|To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.|12 months|90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were analyzed.|||percentage of participants|||Number
2791563|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale|||Number
2791564|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791565|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791566|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.|||percent of participants|||Number
2791567|NCT00581100|Secondary|Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Baseline, Week 24|mITT, N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791568|NCT00581100|Primary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Baseline, Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.|||units on a scale||95% Confidence Interval|Mean
2791569|NCT00581061|Secondary|Side Effects|Number of people who experienced side effects while taking Vesicare, per study protocol.|3 months||||participants|||Number
2791570|NCT00581061|Secondary|Compliance|Number of subjects that were in compliance with the study protocol and took medication for at least one month.|3 months|per protocol|||participants|||Number
2791571|NCT00581061|Primary|Time to Continence|Time in days to achieve pad free urinary continence|12 months||||days||Standard Deviation|Mean
2791572|NCT00581048|Secondary|Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL||baseline to after 16-18 weeks of treatment with vitamin E daily||||UI/ml||Inter-Quartile Range|Median
2791573|NCT00581048|Secondary|Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL||baseline to after 16-18 weeks of treatment with vitamin E daily||||pg/mL||Inter-Quartile Range|Median
2791574|NCT00581048|Secondary|Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine||At baseline and After 16-18 weeks of treatment with vitamin E|Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 2 for diagram of results||||||
2791575|NCT00581048|Primary|Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL)||At baseline to after 16-18 weeks of treatment with vitamin E daily|Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 1 for diagram of results||||||
2791576|NCT00580983|Secondary|The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures|To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.|5 years||||Gray (Gy)||Standard Deviation|Mean
2791726|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791578|NCT00580970|Primary|Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment|The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin. The analysis is using a one-stage design, 5% level of significance, and 83% power.|24 months|The primary endpoint of the study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. Only the highest-grade toxicity for each symptom was counted. Symptoms starting in the acute period and unresolved beyond 90 days post treatment are considered late toxicity.|||percentage of participants|||Number
2791579|NCT00580957|Primary|Insulin Resistance|Glucose infusion rate in mg/kg/min|Last 30 minutes of a two hour insulin clamp||||mg/kg/min||Standard Error|Mean
2791580|NCT00580866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Score|Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )|12 months post-operatively||||scores on a scale||95% Confidence Interval|Mean
2791581|NCT00580866|Primary|Elbow ROM at 12 Months|The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.|2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively|Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.|||degrees||95% Confidence Interval|Mean
2791582|NCT00580853|Secondary|Number of Cigarettes Smoked During the 60 Minute Ad-lib Period|number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period|60 minutes||||number of cigarettes||Standard Error|Mean
2791583|NCT00580853|Primary|Latency to Initiate Ad-lib Smoking Session|minutes to start smoking (range 0 to 50 minutes)|0 to 50 minutes|Subsample with high nicotine dependence|||minutes||Standard Error|Mean
2791584|NCT00580840|Other Pre-specified|Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Joints||Standard Error|Least Squares Mean
2791585|NCT00580840|Other Pre-specified|Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Joints||Standard Error|Least Squares Mean
2791586|NCT00580840|Other Pre-specified|Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Physician's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791587|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||95% Confidence Interval|Least Squares Mean
2791588|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients|Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2791589|NCT00580840|Secondary|Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.|ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.|Week 18 up to Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis.|||days||Inter-Quartile Range|Median
2791614|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients|Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2791746|NCT00579670|Secondary|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?"||Week 12|FAS|||Participants|||Number
2791590|NCT00580840|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791591|NCT00580840|Secondary|Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient's Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791592|NCT00580840|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791593|NCT00580840|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791594|NCT00580840|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791595|NCT00580840|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791596|NCT00580840|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791597|NCT00580840|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791673|NCT00580398|Secondary|Biochemically-validated 7-day Point Prevalence Tobacco Abstinence|"7-day point prevalence abstinence (Have you smoked a cigarette, even a puff, in the past 7 days?) was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm."|12 weeks|46 participants (32 intervention, 14 control) returned a cotinine confirmation kit for biochemical validation of 7 day point prevalent tobacco abstinence at 12 weeks. 3 control participants were excluded from the follow-up analysis.|||participants|||Number
2791598|NCT00580840|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791599|NCT00580840|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791600|NCT00580840|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791601|NCT00580840|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791602|NCT00580840|Secondary|Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18|"Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score."|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791603|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791604|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||Ratio||95% Confidence Interval|Least Squares Mean
2791605|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
2791668|NCT00580606|Primary|Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||Percentage of participants|||Number
2791606|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
2791607|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
2791608|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791609|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791610|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2791611|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
2791612|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
2791613|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2791747|NCT00579670|Secondary|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?"||Week 12|FAS|||Participants|||Number
2791615|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
2791616|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
2791617|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
2791618|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2791619|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2791620|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
2791621|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
2791622|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
2791623|NCT00580840|Secondary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis|||percentage of subjects|||Number
2791624|NCT00580840|Primary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).|||percentage of subjects|||Number
2791625|NCT00580801|Secondary|Average Steady-State Serum Concentration (Css,av) of Telaprevir|The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2791626|NCT00580801|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir|The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."|||Hours||Full Range|Median
2791627|NCT00580801|Secondary|Minimum Serum Concentration (Cmin) of Telaprevir on Day 15|The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2791628|NCT00580801|Secondary|Pre-Dose Serum Concentration (C[0h]) of Telaprevir|The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).|0 hour (pre-dose) at Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2791629|NCT00580801|Secondary|Maximum Serum Concentration (Cmax) of Telaprevir|The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."|||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2791630|NCT00580801|Secondary|Area Under the Serum Concentration-Time Curve (AUC)|The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."|||nanogram*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
2791631|NCT00580801|Secondary|Percentage of Participants With Relapse|Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.|Week 24 after EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. N signifies those participants who were evaluated for this measure."|||Percentage of participants|||Number
2791632|NCT00580801|Secondary|Percentage of Participants With Sustained Viral Response (SVR)|Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.|Week 12 and 24 after the last dose of study medication|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.|||Percentage of participants|||Number
2791633|NCT00580801|Secondary|Number of Participants With Viral Breakthrough (Detectable HCV RNA)|Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 8, Day 12, Day 15, Week 24/26 and Week 36/38|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.|||Participants|||Number
2791634|NCT00580801|Secondary|Median Time to First Viral Response (Undetectable HCV RNA)|Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.|Up to Week 48/50|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.|||Days||95% Confidence Interval|Median
2791669|NCT00580502|Secondary|Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of HbA1c from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.|||percentage of HbA1c||Standard Deviation|Mean
2791674|NCT00580398|Primary|Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.|Number of participants who completed the 12-week follow-up survey and thus the study.|12 weeks||||participants|||Number
2791635|NCT00580801|Secondary|Percentage of Participants With Viral Response (Undetectable HCV RNA)|Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 15 up to EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of participants|||Number
2791636|NCT00580801|Primary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15|The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline and Day 15|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||log 10 IU/mL||Full Range|Median
2791637|NCT00580788|Secondary|Fractional Excretion of Calcium|% calculated from daily second morning void|daily||||% of filtered load||Standard Error|Mean
2791638|NCT00580788|Secondary|Parathyroid Hormone (1-84)|pg/ml|Baseline and Daily||||pg/ml||Standard Error|Mean
2791639|NCT00580788|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
2791640|NCT00580788|Secondary|Amino-terminal Peptides of Procollagen 1 (P1NP)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
2791641|NCT00580788|Secondary|Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
2791642|NCT00580788|Secondary|Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)|% change from baseline|Baseline, Daily, and 1 week follow-up||||% change||Standard Error|Mean
2791643|NCT00580788|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
2791644|NCT00580788|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
2791645|NCT00580788|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
2791646|NCT00580788|Secondary|Tubular Maximum of Phosphorous (TmP/GFR)|mg/dl calculated from daily second morning void|daily||||mg/dl||Standard Error|Mean
2791647|NCT00580788|Secondary|24 Hour Urine Calcium|mg/gm creatinine collected on day 7 of PTHrP infusion|24 hours||||mg/gm creatinine||Standard Error|Mean
2791648|NCT00580788|Secondary|1,25 Vitamin D|pg/ml|Baseline and Daily through day 8 then at follow-up visit||||pg/ml||Standard Error|Mean
2791649|NCT00580788|Primary|Dose Limiting Toxicity (DLT)|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days||||participants|||Number
2791650|NCT00580723|Primary|Telangiectasia Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.|||Telangiectasia percent improvement||Standard Deviation|Mean
2791651|NCT00580723|Primary|Inflammatory Lesion Count|Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.|||Percent change in number of lesions||Standard Deviation|Mean
2791652|NCT00580723|Secondary|Cosmetic Acceptability||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|||||||
2791653|NCT00580723|Secondary|Transepidermal Water Loss (TEWL)||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|||||||
2791654|NCT00580723|Secondary|Skin Photodamage||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|||||||
2791655|NCT00580723|Secondary|Skin Tolerance||Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|||||||
2791670|NCT00580502|Secondary|Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of Triglycerides from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.|||mg/dl||Standard Deviation|Mean
2791671|NCT00580502|Secondary|Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of LDL from baseline at 5 years|5 years|All participants who underwent LAGB are included in the analysis population.|||mg/dl||Standard Deviation|Mean
2791656|NCT00580723|Primary|Erythema Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.|||Erythema percent improvement||Standard Deviation|Mean
2791657|NCT00580671|Primary|Marijuana Abstinence (4 Weeks or Greater)|Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Twice weekly urine tests for 14 weeks.||||percentage of participants|||Number
2791658|NCT00580671|Secondary|Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)|This reflects the mean proportion of days of marijuana abstinence for each participant|This is for the proportion of days abstinent across the entire 14-week treatment period. Self-report data are collected twice weekly during treatment to obtain a cumulative proportion|Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis.|||proportion of marijuana abstinent days||Standard Deviation|Mean
2791659|NCT00580671|Primary|Marijuana Abstinence (2 Weeks or Greater)|Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Testing done twice weekly for 14 weeks.||||percentage of participants|||Number
2791660|NCT00580645|Secondary|Alcohol Craving|alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)|during laboratory session (Day 8) at baseline|n=19 in the 2mg/day varenicline group because 1 subject failed to respond on measure.|||units on a visual analog scale||Standard Error|Mean
2791661|NCT00580645|Primary|Number of Drinks Consumed|number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session|2 hour ad-lib drinking period, during the laboratory session (Day 8)|number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session|||number of drinks||Standard Error|Mean
2791662|NCT00580606|Secondary|Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.|Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy|All subjects randomized to the Low Dose Peanut SLIT group and all subjects randomized to the Placebo group who crossed over to open label high dose peanut sublingual immunotherapy were included.|||percentage of participants|||Number
2791663|NCT00580606|Secondary|Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.|Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.|||participants|||Number
2791664|NCT00580606|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||participants|||Number
2791665|NCT00580606|Secondary|Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 after initiating crossover open label peanut protein consumption|All subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included.|||Percentage of participants|||Number
2791666|NCT00580606|Secondary|Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 after initiating crossover open label peanut protein consumption|Subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included except for 1 subject who refused the crossover Week 44 OFC and could not be evaluated. 4 subjects who discontinued dosing prior to the crossover Week 44 OFC were counted as failures.|||Percentage of participants|||Number
2791667|NCT00580606|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||Percentage of participants|||Number
2791672|NCT00580502|Primary|To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery|Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.|5 years|All participants who underwent LAGB are included in the analysis population.|||percentage of excess weight loss||Standard Deviation|Mean
2791748|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"||Week 12|FAS|||Participants|||Number
2791675|NCT00580372|Primary|Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy|"Relapse is defined by the unequivocal objective evidence of recurrent disease such as:~myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis >10% or >5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for >2 months."|5 years||||percentage of participants|||Number
2791676|NCT00580333|Secondary|Patients With Miller-Payne (MP) Score 3, 4, or 5 Response|To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response).|2 years||||percentage of participants||95% Confidence Interval|Number
2791677|NCT00580333|Secondary|Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.|Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.|2 years|analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment|||Participants|||Count of Participants
2791678|NCT00580333|Secondary|Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||Participants|||Count of Participants
2791679|NCT00580333|Primary|Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.|The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.|2 years||||percentage of participants||95% Confidence Interval|Number
2791680|NCT00580294|Primary|Brief Pain Inventory||Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment|||||||
2791681|NCT00580294|Primary|Change in Patient Global Impression of Change|PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)|baseline and 12 hours||||units on a scale||95% Confidence Interval|Mean
2791682|NCT00580229|Secondary|Adverse Events Assessed From Day 15 Through Week 26.|All adverse events reported from day 15 (24 hours after second infusion) through week 26.|24 weeks||||events|||Number
2791683|NCT00580229|Secondary|Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.|Assessment of all adverse infusion reactions within 24 hours of receipt of the second rituximab infusion|24 hours||||acute infusion reactions|||Number
2791684|NCT00580229|Primary|Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion|Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion|24 hours|The subjects were 18-80 years of age, and fulfilled the 1987 American College of Rheumatology Criteria for Rheumatoid Arthritis, and taking concomitant methotrexate.|||acute infusion reactions|||Number
2791685|NCT00580151|Secondary|Anxiety Reduction|"The Fear Thermometer measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days."|Average of the 10 days|Patients analyzed were all patients consented.|||units on a scale||Full Range|Mean
2791686|NCT00580151|Primary|Pain Reduction|"The scale name is FACES (Faces Pain Rating Scale). Subjects were asked rate your WORST PAIN today (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged."|Average of the 10 days|Determined by the number of patients recruited.|||units on a scale||Full Range|Mean
2791687|NCT00580138|Primary|Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.|Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.|2 years||||percent agreement|||Number
2791688|NCT00580073|Secondary|Overall Survival|Overall survival is defined as the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date of follow-up.|Up to 3 years|This study was closed because of withdrawal of funding. All participants were off study on 02/03/2011.||||||
2791689|NCT00580073|Secondary|Progression Free Survival|Number of participants who achieve progression free survival, defined as the time from date of registration to date of disease progression, up through study closure. Progressive disease is defined as ≥ 20% increase in the sum of the longest dimensions of the primary lesion taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.|Up to 3 years||||participants|||Number
2791690|NCT00580073|Primary|Down-staging of the Tumor; Response to Therapy|Down-staging of the tumor and tumor response rate is defined as the proportion of participant who have any evidence of complete response (CR), pathologic complete response (pCR), or partial response (PR).|6 months||||participants|||Number
2791691|NCT00580047|Secondary|Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation|Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast.|24 months|Compliance in study arm|||percentage of compliance|||Number
2791692|NCT00580047|Primary|Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant|Percentage Change in Posterior Anterior (PA) spine bone density from baseline to 24 months post transplant|24 months|Percentage change in spine bone density from baseline to 24 months|||percentage of change of bone density|||Number
2791749|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?"||Week 12|FAS|||Participants|||Number
2791693|NCT00580034|Secondary|Response|Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR). CR for malignant hematologic diseases is met if all the following are met for >/= 1 month: a) absence of pathologic lymphadenopathy by physical and radiographic exam b) absence of constitutional symptoms due to disease c) Polymorphonuclear leukocyte count >1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL d) bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc. e) molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc. CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values.|2 years|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.|||months||Full Range|Mean
2791694|NCT00580034|Primary|Overall Survival (OS)|Estimate toxicity and overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death.|||months||Full Range|Mean
2791695|NCT00580034|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects on the study who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.|||participants|||Number
2791696|NCT00579982|Secondary|Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation|Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)|End of Study (Week 3) or at Early Withdrawal|ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.|||Number of participants|||Number
2791697|NCT00579982|Secondary|Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3|Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
2791698|NCT00579982|Secondary|Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3|Participant indicated whether preference was for ODT or the standard IR tablet|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
2791699|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
2791700|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])|End of Study (Week 3) or at Early Withdrawal|ITT|||Number of participants|||Number
2791701|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Aftertaste of the Tablet? at Week 3"|Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791702|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Aftertaste of the Tablet? at Week 3."|Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791703|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Strength of the Flavor of the Tablet? at Week 3"|Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791704|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Flavor of the Tablet? at Week 3"|Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791705|NCT00579982|Secondary|"Number of Participants Answering the Question How Did the Dissolved Tablet Feel in Your Mouth? at Week 3"|Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791706|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3"|Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791707|NCT00579982|Secondary|"Number of Participants Answering the Question Did the Tablets Dissolve Instantly (Yes or no)? at Week 3"|The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?|End of Study (Week 3) or Early Withdrawal|ITT|||Number of participants|||Number
2791708|NCT00579982|Secondary|Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3|Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.|Baseline, End of Study (Week 3 weeks) or at Early Withdrawal|ITT|||Points on a scale||Standard Deviation|Mean
2791709|NCT00579982|Secondary|Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3|Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).|Baseline, End of Study (Week 3) or at Early Withdrawal|ITT|||Points on a scale||Standard Deviation|Mean
2791710|NCT00579982|Secondary|Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3|The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.|Baseline, End of Study (Week 3) or Early Withdrawal|ITT|||Points on a subscale||Standard Deviation|Mean
2791711|NCT00579982|Primary|Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.|The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.|Baseline, End of Study (Week 3) or Early Withdrawal|Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.|||Points on a subscale||Standard Deviation|Mean
2791712|NCT00579878|Primary|Measuring the Safety and Efficacy of a New DMARD, Leflunomide,Alone or in Combination With Traditional DMARD's.|The combination of Methotrexate-Sulfasalazine-Hydroxychloroquine has been shown to be more effective than Methotrexate alone or the double combination of Methotrexate-Hydroxychloroquine. Primary outcome is ACR 20 response at 48 weeks.|48 weeks|This will result in a study power of 80%. This power has been calculated assuming an 80% efficacy of the methotrexate-sulfasalazine-hydroxychloroquine combination, an 80% efficacy of the leflunomide-sulfasalazine-hydroxychloroquine combination, and a 40% efficacy of leflunomide alone.|||Participants|||Count of Participants
2791713|NCT00579826|Secondary|Change in Biomarkers Associated With Bone and Cardiovascular Health, Adverse Events, Breast Cancer Prevention Trial (BCPT) Symptom Check List, Hot Flash Score, General Fatigue Inventory, the Fibromyalgia Impact Questionnaire.||6 Months, 12 Months||2019-12-31|12/2019||||
2791714|NCT00579826|Secondary|Change in Mammographic Density From Baseline to 6 Months..|Percent area of the breast considered to be at increased density, as determined by the computer program Cumulus..|Baseline to 6 Months|Subjects who complete the initial 6-months intervention and have mammograms available for analysis at baseline and 6 months, thus a change can be computed.|||percentage of breast at high densit||Standard Deviation|Mean
2791715|NCT00579826|Secondary|Assessment of Change in Morphology by the Masood Score.|Masood score is a semi-quantitative index of increasing abnormality, thus higher values are worse. Range 6 to 24.|Baseline to 6 Months|Subjects who complete initial 6-month intervention and have a repeat RPFNA, thus a change from baseline to 6-months can be computed.|||units on a scale||Standard Deviation|Mean
2791716|NCT00579826|Primary|Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months|Change in proliferation rate (percent positively stained cells for Ki-67 antigen by immunocytochemistry) in benign breast epithelial cells acquired by random periareolar fine needle aspiration from women at high risk for the development of breast cancer.|Baseline to 6 Months|Subjects who complete initial 6-month period and have repeat RPFNA.|||percentage of cells stained positive||Standard Deviation|Mean
2791717|NCT00579813|Primary|Changes in Fat Inflammation Following Pioglitazone|macrophages in fat at baseline, in lean and obese participants, and obese after pioglitazone (in obese)|Baseline and 10 weeks||||macrophages per mm2 by CD68 staining||Standard Deviation|Mean
2791718|NCT00579813|Primary|Changes in Muscle Lipid After Pioglitazone|Muscle lipid following biopsy using oil red-O staining.|At baseline and 10 weeks||||arbitrary units of oil red O staining||Standard Deviation|Mean
2791719|NCT00579813|Primary|Effects of Pioglitazone on Changes in BMI|Body Mass Index (BMI) is measured at baseline, in lean and obese subjects, and after pioglitazone in obese subjects|Baseline and 10 weeks||||kg/m2||Standard Deviation|Mean
2791720|NCT00579813|Primary|Change in Insulin Sensitivity Using FSIGT|The frequently sampled intravenous glucose tolerance test (FSIGT) involves the injection of IV glucose and the frequent measurement of glucose and insulin.|Baseline and 10 weeks||||FSIGT units (x10^-4/min/uU/ml)||Standard Deviation|Mean
2791721|NCT00579670|Post-Hoc|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC||Week 12|Within SmPC|||Participants|||Number
2791722|NCT00579670|Post-Hoc|Percent Change From Baseline to Final Visit in Body Weight: Within SmPC||Baseline, Week 12|Within SmPC|||percent change||Standard Deviation|Mean
2791723|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791727|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791728|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791729|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791730|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791731|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791732|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791733|NCT00579670|Post-Hoc|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participant|||Number
2791734|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791735|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791736|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation|||Participants|||Number
2791737|NCT00579670|Post-Hoc|PANSS - Composite Subscale: Within SmPC|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation|||Scores on a scale||Standard Deviation|Mean
2791738|NCT00579670|Post-Hoc|PANSS - Negative Subscale: Within SmPC|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation|||Scores on a scale||Standard Deviation|Mean
2791739|NCT00579670|Post-Hoc|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation|||Scores on a scale||Standard Deviation|Mean
2791740|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|Within SmPC|||Participants|||Number
2791741|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Within SmPC population: participants in FAS population who received all doses within SmPC. Within SmPC defined as all PO doses up to and including 160 mg per day and all IM doses up to and including 40 mg per day.|||Participants|||Number
2791742|NCT00579670|Secondary|Percent Change From Baseline to Final Visit in Body Weight||Baseline, Week 12|Safety population = all subjects who received at least 1 dose of study medication.|||percent change||Standard Deviation|Mean
2791743|NCT00579670|Other Pre-specified|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period||Week 12|FAS. Four subjects did not answer the question of continuation of treatment.|||Participants|||Number
2791744|NCT00579670|Secondary|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"||Week 12|FAS|||Participants|||Number
2791745|NCT00579670|Secondary|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"||Week 12|FAS|||Participants|||Number
2791751|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"||Week 12|FAS|||Participants|||Number
2791752|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"||Week 12|FAS|||Participants|||Number
2791753|NCT00579670|Secondary|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"||Week 12||||Participants|||Number
2791754|NCT00579670|Secondary|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?"||Week 12||||Participant|||Number
2791755|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"||Week 12|FAS|||Participants|||Number
2791756|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"||Week 12||||Participants|||Number
2791757|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"||Week 12|FAS|||Participants|||Number
2791758|NCT00579670|Secondary|PANSS - Composite Subscale|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
2791759|NCT00579670|Secondary|PANSS - Negative Subscale|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
2791760|NCT00579670|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
2791761|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|FAS; Baseline Visit: 1 subject in the Ziprasidone >=160mg group had missing severity result. Final Visit: 2 subjects (1 subject in the Ziprasidone 120mg to <160mg and 1 subject in the Ziprasidone <80mg group) had missing severity results.|||Participants|||Number
2791762|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.|||Participants|||Number
2791763|NCT00579670|Primary|Summary of Most Frequently Used Concomitant Drug Treatments|Most frequently concomitant drug treatments used by >15 participants.|Baseline|All subjects randomized to a treatment group were included in this baseline analysis.|||Participants|||Number
2791764|NCT00579670|Primary|Summary of Metabolic Risk Factors||Baseline|All subjects randomized to a treatment group were included in this baseline analysis.|||Participants|||Number
2791765|NCT00579670|Primary|Summary of Schizophrenia|Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.|Baseline|All subjects randomized to a treatment group were included in the Baseline analysis.|||Participants|||Number
2791766|NCT00579527|Secondary|Thymus Allograft Biopsy|Evidence, on biopsy of the thymus tissue implanted in muscle, that shows the development of new T cells.|2 to 3 months post-CTTI|Data were only included if the participant had a biopsy of the thymus tissue implanted. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||Participants|||Count of Participants
2791767|NCT00579527|Secondary|Immune Reconstitution Efficacy - Response to Mitogens|Measurement of the T cell proliferative response to the mitogen phytohemagglutin (PHA).|1 year post-CTTI|Data were only included for the 1 year time point if a testing was performed in the relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||counts per minute (cpm)||Full Range|Median
2791768|NCT00579527|Secondary|Immune Reconstitution Efficacy - Naive CD8 T Cells|The development of total naive CD8 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included for the 1 year time point if a T cell count was performed in the relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||cells/mm3||Full Range|Median
2791769|NCT00579527|Secondary|Immune Reconstitution Efficacy - Naive CD4 T Cells|The development of total naive CD4 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included for the 1 year time point if a T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||cells/mm3||Full Range|Median
2791770|NCT00579527|Secondary|Immune Reconstitution Efficacy - Total CD8 T Cells|The development of total CD8 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included for the 1 year time point if a CD8 T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||cells/mm3||Full Range|Median
2791771|NCT00579527|Secondary|Immune Reconstitution Efficacy - Total CD4 T Cells|The development of total CD4 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included for the 1 year time point if a CD4 T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||cells/mm3||Full Range|Median
2791772|NCT00579527|Secondary|Immune Reconstitution Efficacy - Total CD3 T Cells|The development of total CD3 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included for the 1 year time point if a CD3 T cell count was performed in relevant time period. The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||cells/mm3||Full Range|Median
2791773|NCT00579527|Secondary|Survival at 2 Years Post-CTTI|Survival at 2 years post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.|2 years post-CTTI|The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||% of participants who survive to 2 years||95% Confidence Interval|Number
2791774|NCT00579527|Primary|Survival at 1 Year Post-CTTI|Survival at 1 year post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.|1 year post-CTTI|The study was designed to assess survival, without regard to the immune suppression used. No participants were enrolled into Arm 2. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 1 only.|||% of participants who survive to 1 year||95% Confidence Interval|Number
2791775|NCT00579501|Secondary|Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)|The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment.|||percentage of participants|||Number
2791776|NCT00579501|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment.|||percentage of participants|||Number
2791777|NCT00579436|Secondary|Insulin Resistance After Fish Oil Regiment|Insulin sensitivity (Si) was measured with a frequently sampled intravenous glucose tolerance test. Participants received a bolus of glucose at Time Zero, then a bolus of insulin 20 minutes later. Blood was collected through an IV catheter at multiple time points over the course of 4 hours. Glucose and Insulin levels will be plotted on a time course curve and analyzed using the MINMOD algorithm.|week 12|all participants measured|||[mU/L]^-1 x [min]^-1]||Standard Error|Mean
2791778|NCT00579436|Secondary|Baseline Insulin Resistance|Insulin sensitivity (Si) was measured with a frequently sampled intravenous glucose tolerance test. Participants received a bolus of glucose at Time Zero, then a bolus of insulin 20 minutes later. Blood was collected through an IV catheter at multiple time points over the course of 4 hours. Glucose levels were plotted on a time course curve and analyzed using the MIDMOD algorithm.|baseline|all participants were analyzed|||[mU/L]^-1 x [min]^-1]||Standard Error|Mean
2791779|NCT00579436|Primary|Adipocyte Size After Fish Oil Treatment|After completing the fish oil regiment, participant will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine individual adipocyte size|week 12||||square micrometers||Standard Error|Mean
2791780|NCT00579436|Primary|Baseline Adipocyte Size|Prior to starting the fish oil regiment, participants will undergo an incisional abdominal biopsy to remove approximately 4g of adipose tissue to determine adipocyte size|baseline||||square micrometers||Standard Error|Mean
2791781|NCT00579345|Primary|Immunogenicity Assessment by Geometric Mean Titers (GMT).|Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.|Three weeks postvaccination|Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline)|||Titers||95% Confidence Interval|Geometric Mean
2791846|NCT00578864|Primary|Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.|Partial response or better|2 months||||Participants|||Count of Participants
2791782|NCT00579345|Secondary|Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.|"Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96).~CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5."|Three weeks postvaccination|Per Protocol|||Ratio||95% Confidence Interval|Geometric Mean
2791783|NCT00579345|Secondary|Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.|"Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96).~Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10)."|Three weeks postvaccination|Per Protocol Set|||Subjects|||Number
2791784|NCT00579345|Primary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.|One week postvaccination|Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.|||Subjects|||Number
2791785|NCT00579345|Secondary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.|One week postvaccination|Safety Set|||Subjects|||Number
2791786|NCT00579345|Secondary|Number of Unrandomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.|One week postvaccination|Safety set.|||Subjects|||Number
2791787|NCT00579254|Primary|Change in Systolic and Diastolic Blood Pressure|No efficacy results were available from this terminated study.|Baseline, 24 weeks|||||||
2791788|NCT00579137|Secondary|Number of Patients With Grade III to IV Acute GVHD||100 days||||participants|||Number
2791789|NCT00579137|Secondary|Number of Patients With Grade III or IV Toxicity||100 days||||participants|||Number
2791790|NCT00579137|Secondary|Patients Alive at 1 Year||1 Year||||participants|||Number
2791791|NCT00579137|Primary|Number of Patients With Donor Engraftment||100 Days||||participants|||Number
2791792|NCT00579111|Secondary|Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity||100 days||||participants|||Number
2791793|NCT00579111|Primary|Number of Patients With Successful Donor Engraftment|Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.|100 days||||participants|||Number
2791794|NCT00579098|Secondary|Change in Lipid Levels|The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated.|Baseline and 3 months|Intent-to-treat analysis population.|||mg/dL||Standard Deviation|Mean
2791795|NCT00579098|Secondary|Change in Mean Quality of Life Score|A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group.|Baseline and 3 months|Intent-to-treat analysis population.|||units on a scale||Standard Deviation|Mean
2791796|NCT00579098|Secondary|Change in Mean C-Reactive Protein Level||Baseline and 3 months|Intent-to-treat analysis population.|||mg/dL||Standard Deviation|Mean
2791797|NCT00579098|Secondary|Percentage of Subjects Without Atrial Arrhythmia at 3 Months|Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.|Baseline through 3 months|Intent-to-treat analysis population.|||Percentage of subjects|||Number
2791798|NCT00579098|Primary|Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months|Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).|Baseline through 3 months|Intent-to-treat analysis population.|||Percentage of subjects|||Number
2791799|NCT00579059|Secondary|Range of Motion - Flexion|This represents how far the patients were able to flex the knee in the clinic at 1-year.|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.|||degrees||Full Range|Mean
2791800|NCT00579059|Primary|Knee Society Function Score|"The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent, 60-89 is considered Good, 30-59 is considered fair, and 0-29 is considered poor."|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.|||knees|||Number
2791801|NCT00578968|Secondary|Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||percentage of change in HR||Standard Deviation|Mean
2791847|NCT00578812|Secondary|Flexion/Extension Range of Motion at the Operative Level|Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.|24 Months|Per Protocol|||degrees||Standard Deviation|Mean
2791802|NCT00578968|Secondary|Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||percentage of change in SVI||Standard Deviation|Mean
2791803|NCT00578968|Primary|Pretreatment Peak Exercise SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||mL/m^2||Standard Deviation|Mean
2791804|NCT00578968|Secondary|Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||percentage of change in CI||Standard Deviation|Mean
2791805|NCT00578968|Primary|Pretreatment Peak Exercise CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/min/m^2||Standard Deviation|Mean
2791806|NCT00578968|Secondary|Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.|||percentage of change in VO_2||Standard Deviation|Mean
2791807|NCT00578968|Secondary|Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/min||Standard Deviation|Mean
2791808|NCT00578968|Secondary|Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.|||Percentage of change in HR||Standard Deviation|Mean
2791809|NCT00578968|Secondary|Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||bpm||Standard Deviation|Mean
2791810|NCT00578968|Secondary|Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.|||Percentage of change in SVI||Standard Deviation|Mean
2791811|NCT00578968|Secondary|Pretreatment Resting SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||mL/m^2||Standard Deviation|Mean
2791812|NCT00578968|Secondary|Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.|||percentage of change in CI||Standard Deviation|Mean
2791813|NCT00578968|Secondary|Pretreatment Resting CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/min/m^2||Standard Deviation|Mean
2791814|NCT00578968|Secondary|Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.|||Percentage of change in FEV_1||Standard Deviation|Mean
2791815|NCT00578968|Secondary|Pretreatment Resting FEV_1|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||L/sec||Standard Deviation|Mean
2791816|NCT00578968|Secondary|Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.|||percentage of change in FVC||Standard Deviation|Mean
2791817|NCT00578968|Secondary|Pretreatment Resting FVC as Percentage of Predicted FVC|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||percentage of predicted FVC||Standard Deviation|Mean
2791818|NCT00578968|Primary|Baseline Resting Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).|first visit of first study period||||mL/m^2||Standard Deviation|Mean
2791819|NCT00578968|Primary|Baseline Resting Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|First visit of first study period||||L/min/m^2||Standard Deviation|Mean
2791820|NCT00578968|Secondary|Pretreatment Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.|||Liters||Standard Deviation|Mean
2791821|NCT00578968|Secondary|Baseline Peak Exercise Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|second visit of first study period||||mL/m^2||Standard Deviation|Mean
2791822|NCT00578968|Secondary|Baseline Peak Exercise Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|second visit of first study period||||L/min/m^2||Standard Deviation|Mean
2791823|NCT00578968|Secondary|Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|second visit of first study period||||L/min||Standard Deviation|Mean
2791824|NCT00578968|Secondary|Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first visit of first study period, second visit of first study period||||beats per minute (bpm)||Standard Deviation|Mean
2791825|NCT00578968|Secondary|Baseline Resting FEV_1 as Percentage of Predicted FEV_1|Predicted normal values for Forced Expiratory Volume in 1 second can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FEV_1/predicted FEV_1 X 100.|first visit of first study period||||percentage of predicted FEV_1||Standard Deviation|Mean
2791826|NCT00578968|Secondary|Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first visit of first study period||||L/sec||Standard Deviation|Mean
2791827|NCT00578968|Secondary|Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first study period||||percentage of predicted FVC||Standard Deviation|Mean
2791828|NCT00578968|Secondary|Baseline Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First visit of first study period|All COPD participants were included, prior to randomization in the second period of the study.|||Liters||Standard Deviation|Mean
2792119|NCT00577460|Secondary|Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
2791829|NCT00578942|Secondary|Response|"Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR).~CR for malignant hematologic diseases is met if all the following are met for >/= 1 month:~absence of pathologic lymphadenopathy by physical and radiographic exam~absence of constitutional symptoms due to disease~Polymorphonuclear leukocyte count > 1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL~bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc.~molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc.~CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values."|1 year|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.|||participants|||Number
2791830|NCT00578942|Primary|Overall Survival (OS)|Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|Up to 12 years; participants were followed for the duration of the study, an average of 8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. One participant who was lost to follow-up after 14 months was not included. Participants were followed for the duration of the study, an average of 8 years.|||months alive post-infusion||Full Range|Mean
2791831|NCT00578942|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and NCI common terminology criteria for adverse events (CTCAE) v2.0 or 3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the nonablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.Subjects were grouped into 4 categories within the range of cell doses delivered and were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.|||participants|||Number
2791832|NCT00578929|Secondary|Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)|"Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days."|Baseline through 2 weeks after randomization||||Percent change of TOSS from baseline||Standard Error|Least Squares Mean
2791833|NCT00578929|Primary|Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)|"Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days."|Baseline through 2 weeks after randomization||||Percent change of TNSS from baseline||Standard Error|Least Squares Mean
2791834|NCT00578903|Secondary|Number of Subjects Alive at 2 Years Post Transplant||2 years||||participants|||Number
2791835|NCT00578903|Secondary|Number of Subjects Alive at 1 Year Post Transplant||1 year||||participants|||Number
2791836|NCT00578903|Secondary|Number of Patients With Chronic GVHD at 2 Years Post Transplant||2 years||||participants|||Number
2791837|NCT00578903|Secondary|Number of Patients With Acute GVHD at 100 Days Post Transplant||100 days||||participants|||Number
2791838|NCT00578903|Secondary|Number of Patients With Engraftment Rate at 100 Days Post Transplant|Absolute neutrophil count greater than 0.5 X 10^9/ml for at least 3 days|100 days post transplant||||participants|||Number
2791839|NCT00578903|Primary|Number of Subjects Alive at 100 Days Post Transplant||100 days||||participants|||Number
2791840|NCT00578877|Secondary|Percent Women With Urogenital Adverse Events.|Clinically evaluate the safety of the SILCS diaphragm used with contraceptive gel over 6 months of use.|6 months|||||||
2791841|NCT00578877|Primary|Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use||6 months||||percent probability|||Number
2791842|NCT00578864|Secondary|Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.|The first of the two events (relapse or death) was chosen to represent disease free survival|3 years||||Participants|||Count of Participants
2791843|NCT00578864|Secondary|Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy|the measure is the number of patients who have surgery after two cycles of induction|2 months||||Participants|||Count of Participants
2791844|NCT00578864|Secondary|Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.||3 years|number of survival|||Participants|||Count of Participants
2791845|NCT00578864|Primary|Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.|If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia|2 months||||Participants|||Count of Participants
2791848|NCT00578812|Secondary|Nurick's Classification of Disability (Myelopathy)|"Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick's classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient maintained if their Nurick classification grade remained the same or improved if it decreased from baseline to 24 months."|24 Months|Per protocol with extended windows|||participants|||Number
2791849|NCT00578812|Secondary|Patient Satisfaction|Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).|24 Months|Per protocol|||mm||Standard Deviation|Mean
2791850|NCT00578812|Secondary|Dysphagia for Swallowing|Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol|||mm||Standard Deviation|Mean
2791851|NCT00578812|Secondary|Mean SF-36 Mental Component Summary (MCS)|Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per Protocol|||units on a scale||Standard Deviation|Mean
2791852|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)|Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.|24 Months|Per Protocol|||participants|||Number
2791853|NCT00578812|Secondary|Mean SF-36 Physical Component Summary (PCS)|Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol|||units on a scale||Standard Deviation|Mean
2791854|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)|Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
2791855|NCT00578812|Secondary|Mean Neck Disability Index (NDI)|Mean NDI at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol|||units on a scale||Standard Deviation|Mean
2791856|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥15-points at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
2791857|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥20% at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
2791858|NCT00578812|Secondary|Mean Worst Arm Pain Visual Analog Scale|Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol|||mm||Standard Deviation|Mean
2791859|NCT00578812|Secondary|Worst Arm Pain Visual Analog Scale|Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.|24 Months|Per protocol|||participants|||Number
2791860|NCT00578812|Secondary|Mean Neck Pain Visual Analog Scale|Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).|24 Months|per protocol|||mm||Standard Deviation|Mean
2791861|NCT00578812|Secondary|Neck Pain Visual Analog Scale|Improvement of ≥20mm in neck pain at 24 months compared to baseline.|24 Months|per protocol|||participants|||Number
2791862|NCT00578812|Primary|Individual Patient Overall Success|Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.|24 Months|Per Protocol|||participants|||Number
2791863|NCT00578786|Primary|Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)|The number of participants with serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) falling into the following categories: >3.0 and </= 5.0 x ULN, >5.0 and </= 8.0 x ULN, and >8.0 x ULN. Includes the highest value per participant across all visits as well as values from early termination visits.|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 blinded dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||participants|||Number
2791864|NCT00578786|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||percent probability (KM estimate)||95% Confidence Interval|Number
2791865|NCT00578786|Secondary|Percentage of Participants With Failure-Free Treatment Status|Treatment failure was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to ambrisentan in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||percent probability (KM estimate)||95% Confidence Interval|Number
2791866|NCT00578786|Secondary|Percentage of Participants With No Clinical Worsening of PAH|Clinical worsening of PAH was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to AMB in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||percent probability (KM estimate)||95% Confidence Interval|Number
2791973|NCT00578214|Secondary|Respiratory Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||breaths per minute||Standard Deviation|Mean
2795562|NCT00552695|Secondary|Success of Intravenous (IV) Insertion|Percentage of patients in whom intravenous catheter was inserted successfully|After first attempt of catheter insertion||||Percentage of participants|||Number
2791867|NCT00578786|Secondary|Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 36|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
2791868|NCT00578786|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
2791869|NCT00578786|Secondary|Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 12|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
2791870|NCT00578786|Secondary|Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.|||units on a scale||Standard Deviation|Mean
2791871|NCT00578786|Secondary|Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. Missing values were imputed using LOCF based on post-baseline observations.|||participants|||Number
2791872|NCT00578786|Secondary|Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values were imputed using LOCF based on post-baseline observations.|||participants|||Number
2791873|NCT00578786|Secondary|Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values imputed using LOCF based on post-baseline observations.|||participants|||Number
2791874|NCT00578786|Secondary|Baseline World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||participants|||Number
2794132|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2791875|NCT00578786|Secondary|Change From Baseline to Year 3 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||units on a scale||Standard Deviation|Mean
2791876|NCT00578786|Secondary|Change From Baseline to Year 2 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||units on a scale||Standard Deviation|Mean
2791877|NCT00578786|Secondary|Change From Baseline to Year 1 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||units on a scale||Standard Deviation|Mean
2791878|NCT00578786|Secondary|Baseline Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.|||units on a scale||Standard Deviation|Mean
2791879|NCT00578786|Secondary|Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
2791880|NCT00578786|Secondary|Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
2791881|NCT00578786|Secondary|Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 48|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
2791882|NCT00578786|Secondary|Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). Missing values were imputed using LOCF method based on post-baseline observations. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 24|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
2791883|NCT00578786|Primary|Frequently Reported (15% or More Overall) Adverse Events by Severity|The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to AMB in participants with PAH. The most frequently occurring adverse events (occurring in 15% or more of the participants in the combined group) are presented, by severity, that began after entering this extension study. Adverse events that were serious are included. Adverse events are coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 6.1 and are presented by MedDRA preferred term. Severity was graded as follows: mild (AE did not interfere with routine activities; subject may have experienced slight discomfort), moderate (AE interfered with routine activities; subject may have experienced significant discomfort), and severe (AE made it impossible to perform routine activities; subject may have experienced intolerable discomfort or pain).|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Treatment group assignments for the safety analysis set were based upon the highest dose of AMB received at any time during the parent or extension studies.|||participants|||Number
2791884|NCT00578786|Secondary|Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.).|Baseline|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.|||Meters||Standard Deviation|Mean
2791885|NCT00578734|Secondary|Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days||Up to 14 days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.|||days||95% Confidence Interval|Least Squares Mean
2791886|NCT00578734|Primary|Duration of Mechanical Ventilation Through 14 Days|Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.|Up to 14 Days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.|||days||95% Confidence Interval|Least Squares Mean
2791887|NCT00578669|Secondary|Self-reported Depressive Symptoms|Self-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.|One year||||score on a scale||Standard Deviation|Mean
2791888|NCT00578669|Primary|Number of Participants Achieving Smoking Abstinence|7-day point prevalence abstinence|One year||||Participants|||Count of Participants
2791889|NCT00578643|Secondary|Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant.|To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.|Assessed between day 100 and day 365 post transplant|One patient died on day 62 post transplant, and one patient was lost to F/U on day 163 post transplant. They were not assessed for this Outcome Measure.|||Participants|||Count of Participants
2791890|NCT00578643|Secondary|Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant.|To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors.|Assessed between day 0 and day 100 post transplant|One patient who died on day 62 post transplant without developing acute GVHD was not assessed for this Outcome Measure.|||Participants|||Count of Participants
2791891|NCT00578643|Secondary|Number of Patients That Have Complete Donor Chimerism After Transplant.|To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.|120 days post transplant|One patient died on day 62 post transplant and was not included in the analysis.|||participants|||Number
2791892|NCT00578643|Primary|Percentage of Participants With Engraftment|To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.|28 days post transplant||||percentage of participants|||Number
2791893|NCT00578617|Primary|Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up|Documentation of atrial fibrillation using a cardiac event recorder|12 months after intervention||||participants|||Number
2791894|NCT00578565|Secondary|Percentage of Change in Health Associated Quality of Life From Baseline to 48 Weeks|The percentage change from baseline to week 48 in a participant's perception of the impact of health on his or her quality of life was collected on the Health Assessment Questionnaire (HAQ). The HAQ measures a person's ability to function with arthritis. The questionnaire is divided into 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities) which include several questions for each category. The category score is determined by the highest score of the set of questions for each category. The disability score is determined by adding the scores for all categories and dividing by 8. The disability scale ranges from 0 (best - without any difficulty) to 3 (worst - unable to do much).|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||percentage of change||Full Range|Mean
2791895|NCT00578565|Primary|Change in Forced Vital Capacity (FVC) From Baseline to 48 Weeks|FVC is one measure of pulmonary function. For FVC, worsening was defined as decrease of at least 10% and improvement was defined as increase of at least 10%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||participants|||Number
2791896|NCT00578565|Secondary|Change in RA Disease Activity From Baseline to 48 Weeks Using the DAS28 Score.|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||percentage of change||Full Range|Mean
2791897|NCT00578565|Secondary|Assessment of RA Disease Activity Scores as Measured by the DAS28 Score at Baseline and 48 Weeks|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||units on a scale||Full Range|Mean
2791898|NCT00578565|Secondary|Change in Lung Fibrosis Score as Observed on High Resolution Computerized Tomography (HRCT) Scans, From Baseline to 48 Weeks|Three serial HRCT scans of each patient were scored independently and simultaneously by two core radiologists, who were blinded to the sequence in which three scans were obtained (at screening, 24 and 48 weeks). The HRCT scoring sheet scored different domains of abnormality such as, linear opacities, consolidation, ground-glass density, etc. Radiographers reported composite impression based on scoring according to worsening, no worsening or improvement of relevant domains.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||participants|||Number
2791899|NCT00578565|Primary|Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks|DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.|||participants|||Number
2791900|NCT00578552|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|"Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question Have you used any type of tobacco, even a puff, in the past 7 days? and (b) Expired Carbon Monoxide equal or less then 8 parts per million."|12 weeks following start of medication||||participants|||Number
2791901|NCT00578539|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol|1 year|Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.|||percentage of total CD4+ cells||Inter-Quartile Range|Median
2791902|NCT00578461|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.|1 Year|Only 20 of the 26 patients enrolled were included in this analysis as only 20 patients have Treg values at 1 year.|||percentage of total CD4+ cells||Inter-Quartile Range|Median
2791903|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by CTLA-4. Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Kynurenine was measured in micromoles (µM).|Day 1 to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.|||µM||Standard Deviation|Mean
2791904|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by cytotoxic lymphocyte antigen 4 (CTLA-4). Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Tryptophan was measured in micromoles (µM)|Baseline to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.|||µM||Standard Deviation|Mean
2791905|NCT00578448|Secondary|Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants|Acute rejection of transplant defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. Graft loss was defined as either functional loss or physical loss. Day 1 is day of transplantation.|Day 1 up to 4 years post transplantation|All treated participants were analyzed during the planned 3 year study N=12. Only 9 participants entered the LTE so N=9 for LTE.|||participants|||Number
2791906|NCT00578448|Primary|Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. T-HALF was calculated as ln2/Lz, where Lz is the absolute value of the slope of the terminal log-linear phase. T-HALF is measured in hours (h).|Day 84 to Day 112||||hours||Standard Deviation|Mean
2791974|NCT00578214|Secondary|Heart Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment.|||heart beats per minute||Standard Deviation|Mean
2791907|NCT00578448|Primary|Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. Vss was calculated by dividing the dose by AUC and multiply the mean residence time (MRT). Vss was adjusted to body weight and measured as liter per kilogram body weight (l/kg).|Day 84 to Day 112||||l/kg||Standard Deviation|Mean
2791908|NCT00578448|Primary|Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. CLT was calculated by dividing the dose by AUC(TAU) and was adjusted to body weight. CLT was measured as milliliter per time per kg body weight (mL/h/kg).|Day 84 to Day 112|Participants who were treated and had PK data.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2791909|NCT00578448|Secondary|Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population|Blood samples were obtained pre and post dose at designated time points up to Day 112 and thereafter, pre-dose samples were obtained at Days 168 and 364, and then once yearly up to end of Year 3. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The trough serum concentration (Cmin), was recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Cmin was measured as micrograms per milliliter (µg/mL).|Day 1 to Day 1092|Number of participants (N) analyzed = 11 for Days 5, 14,and 28; and 12 for Day 56. Days 84, 112, 168, 364 N=10.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2791910|NCT00578448|Primary|Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). The area under the concentration-time curve in one dose interval [AUC(TAU), where TAU = 4 weeks] were calculated using the mixed log-linear trapezoidal algorithm in Kinetica. Actual sampling times were used for PK calculations. AUC (TAU) was measured as micrograms multiplied by time(h) per milliliter (µg*h/mL).|Day 82 to Day 112||||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2791911|NCT00578448|Primary|Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Tmax measured in hours (h). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 (h) on Day 112 . The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations.|Day 84 to Day 112|1 participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Tmax, Number of participants analyzed (N)=9.|||hours||Full Range|Median
2791912|NCT00578448|Primary|Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population|Cmax, Cmin are measured in micrograms per milliliter (µg/mL). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. Serum samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The Cmax, and the Cmin were recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Values below lower limits of quantification (LLQ), 0.003 µg/mL, were set to 0.0015 for computation of summary statistics.|Day 84 to Day 112|One participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Cmax, Number of participants analyzed (N)=9.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2791913|NCT00578448|Primary|Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing.|Day 84 to Day 112|Number (N) of participants analyzed for each collection time was 10, except for time 0.50 h, which was missing 1 participant. Therefore Number (N) for Time 0.50 h = 9.|||ng/mL||Standard Deviation|Mean
2791975|NCT00578214|Secondary|Blood Pressure at 30 Minutes||30 minutes after drug administration||||mm Hg||Standard Deviation|Mean
2791996|NCT00578175|Secondary|Concentration of Antibodies to Rubella Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||International units per milliliter||95% Confidence Interval|Geometric Mean
2791914|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791915|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791916|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791917|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791918|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791919|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Bipolar Depression|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791920|NCT00578383|Primary|Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791921|NCT00578383|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791922|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.|||units on a scale||Standard Error|Mean
2791923|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.|||units on a scale||Standard Error|Mean
2791924|NCT00578383|Secondary|Visual Analog Scale (VAS): Combined Diagnostic Groups.|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.|||units on a scale||Standard Error|Mean
2792014|NCT00577889|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|Assessed up to 2 years from registration||||months||95% Confidence Interval|Median
2791925|NCT00578383|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.|||units on a scale||Standard Error|Mean
2791926|NCT00578331|Secondary|Average Number of Days of Rescue Medication Taken||Month 1 through Month 12|12 patients had missing average use of rescue medication data.|||Days||Standard Deviation|Mean
2791927|NCT00578331|Primary|Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire|Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.|day 30|29 patients had missing mean patient-rated relief assessment data.|||Unit on PRRA scale||Standard Deviation|Mean
2791928|NCT00578318|Primary|Attendance at First Depression Treatment Appointment|Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).|Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)||||participants|||Number
2791929|NCT00578305|Secondary|Adverse Events (AEs), Laboratory Parameters, C-reactive Protein, ESR.||Throughout study|||||||
2791930|NCT00578305|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
2791931|NCT00578305|Secondary|Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures|Correlation coefficients of magnetic resonance imaging erosion, synovitis, and osteitis scores and clinical outcome measures of swollen joint count (SJC), tender joint count (TJC), C-reactive protein level (CRP), erythrocyte sedimentation rate (ESR), a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (GH), Disease Activity Score 28-C-reactive protein (DAS28-CRP), and Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) are reported. Not all of these variables were specified as primary or secondary Outcome Measures in the study protocol and were not individually analyzed.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Correlation coefficient|||Number
2791932|NCT00578305|Secondary|Percentage of Participants Achieving a Major Clinical Response at Week 52|"A major clinical response was defined as an improvement of at least 70% in the American College of Rheumatology score from Baseline at Week 52. Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate participant and physician assessments of participant disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity); participant assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein level."|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791933|NCT00578305|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52|Improvement must be seen in tender and swollen joint counts (28 assessed joints; Joints were evaluated and classified as swollen or not swollen and tender or not tender based on pressure and joint manipulation upon physical examination) and in at least 3|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791934|NCT00578305|Secondary|Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52|The percentage of participants in remission of their rheumatic arthritis at Weeks 24 and 52, as measured by a DAS28 score < 2.6, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791976|NCT00578214|Secondary|Patient Cognitive Function at 120 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|120 minutes after drug administration|The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
2791935|NCT00578305|Secondary|Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52|The percentage of participants who had low rheumatic arthritis disease activity at Weeks 24 and 52, as measured by a DAS28 score ≤ 3.2, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791936|NCT00578305|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52|Change of the DAS28 score from Baseline was used to determine the EULAR responses. For a post-Baseline score ≤ 3.2, a change from Baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-Baseline score > 3.2 to ≤ 5.1, a change from Baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-Baseline score > 5.1, a change from Baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-Baseline scores > 3.2. DAS28=(0.56×√(TJC28))+(0.28×√(SJC28))+(0.7×log(CRP))+(0.014×GH), where TJC28=tender joint count (JC) and SJC28=swollen JC (28 joints), GH=a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end=no disease activity, right end=maximum disease activity), and CRP=C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791937|NCT00578305|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, C-reactive protein level (CRP), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
2791938|NCT00578305|Secondary|Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52|There were 2 definitions of improvement in osteitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > than the smallest detectable change. The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791939|NCT00578305|Secondary|Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52|There were 2 definitions of improvement in synovitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > than the smallest detectable change. The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791940|NCT00578305|Secondary|Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52|There were 2 definitions of no progression/no worsening in bone erosion. A participant met the criterion for definition 1 when there was a change in the magnetic resonance imaging erosion score ≤ 0. A participant met the criteria for definition 2 when there was either (1) no change from Baseline in the MRI erosion score, (2) an increase in erosion score and the size of the increase in score was smaller than the smallest detectable change, or (3) a drop in the erosion score. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791977|NCT00578214|Secondary|Patient Cognitive Function at Baseline and 60 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|baseline (prior to drug administration) and 60 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
2791941|NCT00578305|Secondary|Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52|No newly eroded joints was defined as no new erosions in joints which were scored 0 at baseline. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Percentage of participants|||Number
2791942|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52|The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% increase in the volume of the peripheral 1 cm of original (eroded + residual) articular bone using the following scale: 0.0=normal, no osteitis; 0.5=1-17% involvement of original articular bone; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% involvement of original articular bone. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
2791943|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52|The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 3 wrist regions and 5 metacarpophalangeal joints in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% enhancement of the maximum volume of enhancing tissue in the synovial compartment using the following scale: 0.0=normal, no synovitis; 0.5=1-17% estimated volume of enhancement; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% estimated volume of enhancement. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
2791944|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
2791945|NCT00578305|Primary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.|||Units on a scale||Standard Deviation|Mean
2791946|NCT00578279|Primary|The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection|Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.|baseline up to 1 year||||units on a scale||Standard Deviation|Mean
2791947|NCT00578227|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2791948|NCT00578227|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse events include any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2791949|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the safety follow-up (from Month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2791950|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2791951|NCT00578227|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.|During the 7-day period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2791952|NCT00578227|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.|During the 7-day period (Day 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2791953|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2791954|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||Participants|||Count of Participants
2791955|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs before vaccination, i.e. with antibody titers below 3.3 mIU/mL.|||mIU/mL||95% Confidence Interval|Geometric Mean
2791956|NCT00578227|Secondary|Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies|"Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.~A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL."|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs with antibody titers below 3.3 mIU/mL.|||Participants|||Count of Participants
2791957|NCT00578227|Secondary|Anti-HAV Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.|||mIU/mL||95% Confidence Interval|Geometric Mean
2791958|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HAV Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.|||Participants|||Count of Participants
2791959|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2791978|NCT00578214|Primary|Patient Anxiety at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
2791960|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||Participants|||Count of Participants
2791961|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HBs Antibodies|Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.|At month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination.|||Participants|||Count of Participants
2791962|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titers below 3.3 mIU/mL.|||mIU/mL||95% Confidence Interval|Geometric Mean
2791963|NCT00578227|Primary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2791964|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.|||Participants|||Count of Participants
2791965|NCT00578227|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titer greater than or equal to 3.3 mIU/mL.|||Participants|||Count of Participants
2791966|NCT00578227|Primary|Anti-Heptatis A (HAV) Antibody Titers.|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).|||mIU/mL||95% Confidence Interval|Geometric Mean
2791967|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).|||Participants|||Count of Participants
2791968|NCT00578214|Secondary|Pulse Oximetry at 60 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.|||percentage of oxygenation||Standard Deviation|Mean
2791969|NCT00578214|Secondary|Respiratory Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.|||breaths per minute||Standard Deviation|Mean
2791970|NCT00578214|Secondary|Heart Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||heart beats per minute||Standard Deviation|Mean
2791971|NCT00578214|Secondary|Blood Pressure at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||mm Hg||Standard Deviation|Mean
2791972|NCT00578214|Secondary|Pulse Oximetry at 30 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.|||percentage of oxygenation||Standard Deviation|Mean
2792065|NCT00577824|Secondary|Change in Fasting Blood Glucose|Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
2791979|NCT00578214|Secondary|Patient Alertness at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm and 1 patient in the prospective midazolam arm did not complete this assessment.|||units on a scale||Standard Error|Mean
2791980|NCT00578214|Secondary|Patient Alertness at Baseline|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
2791981|NCT00578214|Primary|Patient Anxiety at Baseline|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm, 2 patients in the placebo arm, and 1 patient in the prospective midazolam arm did not complete this assessment.|||units on a scale||Standard Deviation|Mean
2791982|NCT00578175|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2791983|NCT00578175|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits|New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2791984|NCT00578175|Secondary|Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)|"Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel."|During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
2791985|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
2791986|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Varicella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
2791987|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
2791988|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination|Fever was measured rectally.|During the 43-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
2791989|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination|Fever was measured rectally.|During the 15-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
2791990|NCT00578175|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4 day follow up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.|||subjects|||Number
2791991|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2791992|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2791993|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2791994|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2791995|NCT00578175|Secondary|Number of Subjects With Vaccine Response to Havrix|Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2791997|NCT00578175|Secondary|Concentration of Antibodies to Measles Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2791998|NCT00578175|Secondary|Antibody Titers to Mumps Virus|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||titer||95% Confidence Interval|Geometric Mean
2791999|NCT00578175|Primary|Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2792000|NCT00578175|Primary|Concentration of Antibodies to Hepatitis A Virus (HAV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2792001|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Rubella Virus|Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2792002|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Measles Virus|Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2792003|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Mumps Virus|Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2792004|NCT00578175|Primary|Concentration of Antibodies to Varicella Virus (VZV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2792005|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)|Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
2792006|NCT00578136|Secondary|The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.|difference in time to rescue analgesic and the differences in side effects for the two groups.|immediate to 24 hours post-operatively|Time to first rescue dose of opioid medication.|||minutes||Standard Deviation|Mean
2792007|NCT00578136|Primary|The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.|total postoperative opioid and any additional analgesic medications.|immediate to 24 hour post-operatively||||mg kg-1||95% Confidence Interval|Mean
2792008|NCT00578071|Secondary|Pathological Complete Response Rates Associated With This Regimen.|Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.|90 days|Surgery was determined according to risk factors, patient consent and resectability.|||percentage of participants|||Number
2792009|NCT00578071|Secondary|Overall Survival Rates for the Patients Studied on This Protocol.|Number of patients alive one year after completing study protocol treatment.|One year||||participants|||Number
2792010|NCT00578071|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)||Within 30 days of the last day of radiation|All patients who received chemoradiation.|||participants|||Number
2792011|NCT00578071|Primary|Panitumumab Maximum Tolerated Dose in Milligrams (mg)||60 days|Per protocol and intention to treat (ITT).|||mg|||Number
2792012|NCT00577889|Secondary|Confirmed Response Rate|"A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria."|2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment||||participants|||Number
2792013|NCT00577889|Secondary|Time to Disease Progression|"The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD."|Time from registration to documentation of disease progression, assessed up to 2 years||||months||95% Confidence Interval|Median
2792015|NCT00577889|Primary|Six Month Survival Rate|"A patient that is alive at 6 months is considered a treatment success. Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|6 months||||percentage of patients||95% Confidence Interval|Number
2792016|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 46 Weeks|Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.|||number of participants with complaints|||Number
2792017|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 46 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.|||number of complaints|||Number
2792018|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of what could be done to improve the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792019|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792020|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792021|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reusing Needles|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792022|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792023|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are at home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792024|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen reduces their reluctance to take injections.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792025|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how convenient Forteo B Pen was to use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792026|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how confident they were that they received the medication with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792027|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how satisfied they were with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792028|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of the overall ease of use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792029|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to use the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792118|NCT00577460|Secondary|Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||beats per minute||Standard Deviation|Mean
2792030|NCT00577863|Secondary|Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to hold the pen while injecting.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792031|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to push the black injections button to administer the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792032|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to set the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792033|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove a used needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792034|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to attach a new needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792035|NCT00577863|Secondary|Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to replace the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792036|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792037|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to learn to use the pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792038|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Read Label|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to read the label.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792039|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen from the package.|8 weeks|All participants who received at least one injection of study drug and who answered the question.|||participants|||Number
2792040|NCT00577863|Secondary|Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen|To assess subject preferences for use of the User Manual/Instructions for Use that came with the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792041|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Ease of Use|To assess subject preferences for overall ease of use for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792042|NCT00577863|Secondary|Summary of Subject Preference Assessments - Removing a Used Needle|To assess subject preferences for removing a used needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792043|NCT00577863|Secondary|Summary of Subject Preference Assessments - Assurance That Drug is Delivered|To assess subject preferences for assurance that drug is delivered for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792044|NCT00577863|Secondary|Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose|To assess subject preferences for force on the plunger needed to inject a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792045|NCT00577863|Secondary|Summary of Subject Preference Assessments - Injecting a Dose|To assess subject preferences for injecting a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792046|NCT00577863|Secondary|Summary of Subject Preference Assessments - Setting the Dose|To assess subject preferences for setting the dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792047|NCT00577863|Secondary|Summary of Subject Preference Assessments - Attaching a New Needle|To assess subject preferences for attaching a new needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792048|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 8 Weeks|Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.|||number of participants with complaints|||Number
2792049|NCT00577863|Secondary|Summary of Subject Preference Assessments - Learning to Use the Pen|To assess subject preferences for learning to use the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792050|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Preference|To assess overall subject preferences for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.|||participants|||Number
2792051|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 8 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.|||number of complaints|||Number
2792052|NCT00577824|Secondary|Change in 1,5-anhydroglucitol|Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||mcg/mL||Standard Error|Mean
2792053|NCT00577824|Secondary|Change in C-peptide|Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ng/mL||Standard Error|Mean
2792054|NCT00577824|Secondary|Change in Serum Insulin|Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||mcU/mL||Standard Deviation|Mean
2792055|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)|Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ratio||Standard Error|Mean
2792056|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)|Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ratio||Standard Error|Mean
2792057|NCT00577824|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24|Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||mg/dL||Standard Deviation|Mean
2792058|NCT00577824|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||ratio (cm/cm)||Standard Error|Mean
2792059|NCT00577824|Secondary|Change in Waist Size|Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward|||cm||Standard Error|Mean
2792060|NCT00577824|Secondary|Change in Triglycerides|Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||mg/dL||Standard Error|Mean
2792061|NCT00577824|Secondary|Change in High Density Lipoprotein Cholesterol (HDL-C)|Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.|||mg/dL||Standard Error|Mean
2792062|NCT00577824|Secondary|Change in Low Density Lipoprotein Cholesterol (LDL-C)|Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.|||mg/dL||Standard Error|Mean
2792063|NCT00577824|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||mg/dL||Standard Error|Mean
2792064|NCT00577824|Secondary|Change in Body Weight|Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)|baseline, week 24|Full analysis set; Last observation carried forward|||kg||Standard Error|Least Squares Mean
2792066|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 6.5%|Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only subjects whose HbA1c was >=6.5% at baseline were included.|||percentage of participants|||Number
2792067|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 7.0%|Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only those patients with HbA1c >=7% at baseline included.|||percentage of participants|||Number
2792068|NCT00577824|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|baseline, 24 weeks|Full analysis set; Last observation carried forward.|||Percentage of hemoglobin||Standard Error|Least Squares Mean
2792069|NCT00577772|Primary|Oro-cecal Transit Time as Measured by SmartPill|Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H_2BT technique.|baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline|Data were not analyzed as study was terminated early due to low enrollment.||||||
2792070|NCT00577720|Secondary|Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population||Baseline and Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2792071|NCT00577720|Secondary|Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population||Baseline and Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2792072|NCT00577720|Primary|Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population||Baseline and Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2792073|NCT00577707|Secondary|Number of Patients With a Response Rate, 3-year Overall Survival and Median Survival of Patients With a Known EGFR Mutation Receiving Neoadjuvant Chemotherapy and Erlotinib (and Adjuvant Erlotinib).||3 years|Data was not collected because of lack of accrual.||||||
2792074|NCT00577707|Secondary|Number of Participants With Response After 21 Days of Single Agent Erlotinib for Stage IB-IIIA NSCLC With a Known EGFR Mutation||calculate the response rate after 21 days of single agent erlotinib|Data was not collected because of lack of accrual.||||||
2792075|NCT00577707|Primary|Number of Patients With Pathologic Complete Response Rate|Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the measured lesions, and any increase of less than 25% in the sum of the products of the measured lesions. There may be no appearance of new disease sites for this category. Progressive Disease (PD): A ≥25% increase in one or more lesions, or appearance of new lesions.|Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.||||participants|||Number
2792076|NCT00577655|Secondary|Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night and the number of puffs of rescue albuterol used during the night after going to bed. At the end of each day, the number of puffs of albuterol rescue medication used during the day were recorded.|Weeks 1, 2, 3|ITT population|||Number of puffs per day||95% Confidence Interval|Mean
2792077|NCT00577655|Secondary|Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning|Participants measured their PEF as trained by taking as deep a breath as possible, placing their mouth firmly around the mouthpiece of the flow meter to form a tight seal, and exhaling as hard and as fast as possible. Subjects repeated the process twice at intervals of approximately 30 seconds, and then recorded the highest of the three PEF values on the diary card.|Weeks 1, 2, 3|ITT population|||Liters/minute||Standard Error|Mean
2792078|NCT00577655|Secondary|The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Run-in (Days -21 to -1), Weeks 1, 2, 3|ITT population|||awakenings/week||Standard Deviation|Mean
2792079|NCT00577655|Secondary|Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3|"Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms were scored daily on a four-point scale:~0 = No symptoms occurred~1 = Symptom occurred but did not interfere with daily activity~2 = Symptom occurred but was sometimes annoying or interfered with daily activity~3 = Symptom present even at rest and was annoying or interfered with daily activity"|Weeks 1, 2, 3|ITT population.|||units on a scale||Standard Error|Mean
2792080|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+12% increase in PEF within 30 minutes of dose.~The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
2794133|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2792081|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+15% increase in PEF within 30 minutes of dose.~The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
2792082|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+12% increase in FEV1 within 30 minutes of dose.~The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
2792083|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+15% increase in FEV1 within 30 minutes of dose.~The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT|||percentage of participants|||Number
2792084|NCT00577655|Secondary|Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.~Time to maximum PEF is defined as the number of minutes required for the baseline PEF to increase to the highest PEF post-dose for the 6 hour observation period. Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|ITT population; Last Observation Carried Forward (LOCF) used for Day 22|||minutes||95% Confidence Interval|Median
2792085|NCT00577655|Secondary|Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters.~Time to maximum FEV1 is defined as the number of minutes required for the baseline FEV1 to increase to the highest FEV1 post dose during the 6 hour observation period.~Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Intent-To-Treat (ITT) population; Last Observation Carried Forward (LOCF) used for Day 22|||minutes||95% Confidence Interval|Median
2792086|NCT00577655|Secondary|Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case)|The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.|Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)|||percentage of predicted FEV1||Standard Error|Mean
2792087|NCT00577655|Secondary|Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.~The area under-the-effect curves for PEF were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||Liters/Minute*Hours||Standard Error|Mean
2792088|NCT00577655|Secondary|Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.~The area under-the-effect curves for percent-predicted FEV1 were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation)|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||Percent of Predicted FEV1 * Hours||Standard Error|Mean
2792089|NCT00577655|Secondary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing on study days 1 and 22. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|Observed cases|||percentage change from baseline||Standard Error|Mean
2792090|NCT00577655|Secondary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using test day baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)|||percentage change from baseline||Standard Error|Mean
2792091|NCT00577655|Primary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||percentage change from baseline||Standard Error|Mean
2792092|NCT00577655|Primary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)|||percentage change from baseline||Standard Error|Mean
2792093|NCT00577642|Primary|Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr|Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.|6 months||||Participants|||Count of Participants
2792094|NCT00577629|Secondary|Secondary Malignancies|The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.|10 years|All patients who received chemotherapy|||Participants|||Count of Participants
2792095|NCT00577629|Secondary|Overall Response|"Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.~CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PR =~>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~No increase should be observed in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.~Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.~No new sites of disease should be observed."|up to 1 year||||percentage of participants|||Number
2792096|NCT00577629|Secondary|Overall Survival|Overall Survival is measured from the first day of chemotherapy until death from any cause.|10 years|All subjects who received chemotherapy|||percentage of participants|||Number
2792097|NCT00577629|Secondary|Disease-free Survival|Disease-free survival is measured from the date of CR or CRu to date of relapse or death|10 years|"Subjects who achieved a complete response. 9 patients experienced disease progression; 4 patients died.~4 patients were lost-to-follow-up and 11 patients are still living, so DFS was calculated using the last date of follow-up."|||months||Full Range|Mean
2792098|NCT00577629|Primary|1 Year Progression-free Survival Rate|Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.|1 year||||percentage of participants||95% Confidence Interval|Number
2792099|NCT00577590|Primary|Percent Change in Plasma Triglycerides||Baseline and 3 months|Data presented are stratified by sex|||percent change||Standard Deviation|Mean
2792100|NCT00577512|Primary|Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.|"Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions.~Near Complete Response included all elements of CR except immunofixation studies remained positive."|12 months||||participant response|||Number
2795642|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients|||Participants|||Number
2792101|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
2792102|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
2792103|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 6|All Randomized Patients|||Percentage of Participants|||Number
2792104|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 3|All Randomized Patients|||Percentage of Participants|||Number
2792105|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)|0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
2792106|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)|0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
2792107|NCT00577473|Secondary|Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
2792108|NCT00577473|Secondary|Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
2792109|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients|||Percentage of Participants|||Number
2792110|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients|||Percentage of Participants|||Number
2792111|NCT00577473|Secondary|Percentage of Patients Classified as Treatment Success at Week 3, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|3 weeks|ITT Population|||Percentage of Participants|||Number
2792112|NCT00577473|Primary|Percentage of Patients Classified as Treatment Success at Week 6, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|6 weeks|ITT Population|||Percentage of Participants|||Number
2792113|NCT00577460|Secondary|Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set|The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.|Baseline, 80 weeks|Treated Set - all patients dispensed drug and documented to have taken at least one dose|||participants|||Number
2792114|NCT00577460|Secondary|Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set|ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|OL Baseline and Week 80||||units on a scale||Standard Deviation|Mean
2792115|NCT00577460|Secondary|Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||kg||Standard Deviation|Mean
2792116|NCT00577460|Secondary|Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||kg||Standard Deviation|Mean
2792117|NCT00577460|Secondary|Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||beats per minute||Standard Deviation|Mean
2792120|NCT00577460|Secondary|Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
2792121|NCT00577460|Secondary|Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
2792122|NCT00577460|Secondary|Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data|||mm Hg||Standard Deviation|Mean
2792123|NCT00577460|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.|80 weeks|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)|||Percentage of participants|||Number
2792124|NCT00577460|Secondary|Number of Participants With Serious Adverse Events||80 weeks|The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment|||Patients|||Number
2792125|NCT00577460|Secondary|Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline||OL baseline and week 80|Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80|||Patients|||Number
2792126|NCT00577460|Secondary|Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80||OL baseline and week 80|Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80|||Patients|||Number
2792127|NCT00577460|Secondary|Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80|PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD|OL baseline and week 80|Patients from FAS with values of PFS-16 score at week 80|||Unit on a scale||Standard Error|Least Squares Mean
2792128|NCT00577460|Secondary|UPDRS IV Total Score and Change From OL Baseline at Week 80|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|OL baseline and week 80|Patients from FAS with values of UPDRS IV at week 80|||Unit on a scale||Standard Error|Least Squares Mean
2792129|NCT00577460|Secondary|UPDRS III Total Score and Change From OL Baseline at Week 80|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|OL baseline and week 80|Patients from FAS with values of UPDRS III at week 80|||units on a scale||Standard Error|Least Squares Mean
2792130|NCT00577460|Secondary|UPDRS II Total Score and Change From OL Baseline at Week 80|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities|OL baseline and week 80|Patients from FAS with values of UPDRS II at week 80|||units on a scale||Standard Error|Least Squares Mean
2792131|NCT00577460|Secondary|UPDRS I Total Score and Change From OL Baseline at Week 80|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|OL baseline and week 80|Patients from FAS with values of UPDRS I at week 80|||units on a scale||Standard Error|Least Squares Mean
2792132|NCT00577460|Secondary|Number of Participants With Response in PGI-I for Early Morning Off Symptoms|"Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I for early morning off symptoms at week 32|||Patients|||Number
2792133|NCT00577460|Secondary|Number of Participants With Response in PGI-I|"Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I at week 32|||Patients|||Number
2792134|NCT00577460|Secondary|Number of Participants With Response in CGI-I|"Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders"|32 weeks|Patients from FAS with values of CGI-I at week 32|||Patients|||Number
2792135|NCT00577460|Secondary|Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
2792136|NCT00577460|Secondary|Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
2792165|NCT00577135|Secondary|Change in Cystatin C||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/L||Standard Deviation|Mean
2792137|NCT00577460|Secondary|Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
2792138|NCT00577460|Secondary|Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
2792139|NCT00577460|Secondary|Number of Participants With Response in Percentage Off Time During Waking Hours|Response means >=20% improvement relative to OL baseline in the % off-time during waking hours|80 weeks|Patients from FAS with values of off time during waking hours at 80 weeks|||Patients|||Number
2792140|NCT00577460|Secondary|Percentage Off Time During Waking Hours Total Score: Change From Baseline|"Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).~A negative change implies improvement"|Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80|||percentage during waking hours||Standard Error|Least Squares Mean
2792141|NCT00577460|Secondary|Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time|A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|One week|Patients from FAS and who maintain the final dose of the previous study|||Patients|||Number
2792142|NCT00577460|Secondary|Number of Participants With UPDRS II+III Response|A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Week 80|Patients from FAS with values of UPDRS II+III at week 80|||Patients|||Number
2792143|NCT00577460|Secondary|UPDRS II+III Change From Open Label (OL) Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80|||Scores on a scale||Standard Error|Least Squares Mean
2792144|NCT00577460|Secondary|Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III|Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|One week|Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study|||Patients|||Number
2792145|NCT00577408|Primary|Treatment Retention|compliance with being retained in treatment protocol|over the course of 24 weeks or length of study participation||||Participants|||Count of Participants
2792146|NCT00577395|Secondary|Erosion Index of the Distal Radius|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|6 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.||||||
2792147|NCT00577395|Primary|Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius|"The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).~NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed."|12 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.||||||
2792148|NCT00577382|Secondary|Time to Progression|Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).|The analysis dataset is comprised of treated patients. The majority of patients were off-treatment due to disease progression and thus the relevant observation time frame for this outcome is time on treatment.|||months||95% Confidence Interval|Median
2792149|NCT00577382|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
2792166|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better|72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
2792150|NCT00577382|Secondary|Best Overall Response Rate|The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.|The analysis dataset is comprised of treated patients.|||proportion of participants||95% Confidence Interval|Number
2792151|NCT00577382|Primary|2-month Progression-free Survival Rate|2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.|The analysis dataset is comprised of treated patients.|||proportion of patients||95% Confidence Interval|Number
2792152|NCT00577356|Primary|Number of Participants With Pathological Complete Response.|CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen|The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.|Study was stopped before analysis occured.|||participants|||Number
2792153|NCT00577135|Secondary|Net Fluid Loss||Through 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mL||Standard Deviation|Mean
2792154|NCT00577135|Secondary|Net Fluid Loss||Through 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mL||Standard Deviation|Mean
2792155|NCT00577135|Secondary|Net Fluid Loss||Through 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mL||Standard Deviation|Mean
2792156|NCT00577135|Secondary|Treatment Failure|Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization|Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||percentage of participants|||Number
2792157|NCT00577135|Secondary|Presence of Cardiorenal Syndrome||Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||percentage of participants|||Number
2792158|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||pg/mL||Standard Deviation|Mean
2792159|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||pg/mL||Standard Deviation|Mean
2792160|NCT00577135|Secondary|Change in B-type Natriuretic Peptide|Change in NTproBNP|baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||pg/mL||Standard Deviation|Mean
2792161|NCT00577135|Secondary|Change in Uric Acid||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792162|NCT00577135|Secondary|Change in Uric Acid||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792163|NCT00577135|Secondary|Change in Uric Acid||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792164|NCT00577135|Secondary|Change in Cystatin C||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/L||Standard Deviation|Mean
2792167|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
2792168|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
2792169|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
2792170|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792171|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792172|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792173|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792174|NCT00577135|Secondary|Change in Cystatin C||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/L||Standard Deviation|Mean
2792175|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792176|NCT00577135|Secondary|Dyspnea, as Determined by Visual Analog Scales|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
2792177|NCT00577135|Secondary|Proportion of Patients Free of Congestion||Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||percentage of participants|||Number
2792178|NCT00577135|Secondary|Change in Weight||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||lbs||Standard Deviation|Mean
2792179|NCT00577135|Primary|Change in Serum Creatinine||Measured at baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||mg/dL||Standard Deviation|Mean
2792180|NCT00577135|Primary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-7200; higher score is better|Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.|||units on a scale||Standard Deviation|Mean
2792181|NCT00577122|Secondary|MPA Trough Concentration|To explore genetic determinants of MPA bioavailability and trough concentration by showing average MPA levels at cycle 1 (Day 10-14) and cycle 2 (Day 1).|Cycle 1 (Day 10-14) and Cycle 2 (Day 1)|All patients with available data|||ng/mL||Standard Deviation|Mean
2792182|NCT00577122|Secondary|MPA Trough Level > 50 ng/mL When Have Clinical Benefit|To explore the relationship between MPA trough level and clinical benefit. This is done by seeing if the MPA concentrations remained > 50 ng/mL after initial dose escalation for those patients who showed clinical benefit. The number shows how many of the patients who showed clinical benefit had MPA concentrations > 50 ng/mL.|baseline through end of treatment|Patients who showed clinical benefit (CR, PR, or SD > 6 months)|||participants|||Number
2792183|NCT00577122|Secondary|Grade 3 or 4 Adverse Events Related to Treatment|To evaluate the toxicity of MPA and MPA + ldoCM in this patient population by the number of patients who have grade 3 or 4 adverse events that are related to treatment.|baseline through end of treatment|All patients in the study|||participants|||Number
2792753|NCT00572572|Primary|Complete Response.|Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.|Participants were evaluated from start of treatment through day 8 of cycle 2.||||percentage of evaluable subjects|||Number
2792754|NCT00572533|Post-Hoc|RBC Units Transfused|Total number of RBC units transfused|12 months|Intent-To-Treat, Missing Data Excluded|||RBC Units|||Number
2792184|NCT00577122|Primary|Clinical Benefit Rate (CR + PR + SD > 6 Months).|To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.|baseline through end of study, up to 3 years|All Patients on study.|||Percent of Participants||95% Confidence Interval|Number
2792185|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||g/dl||Standard Deviation|Mean
2792186|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||g/dl||Standard Deviation|Mean
2792187|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Days||Standard Deviation|Mean
2792188|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Days||Standard Deviation|Mean
2792189|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Stem Cell Collection Attempts||Standard Deviation|Mean
2792190|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Stem Cell Collection Attempts||Standard Deviation|Mean
2792191|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Platelet Transfusions||Standard Deviation|Mean
2792192|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||Platelet transfusions||Standard Deviation|Mean
2792193|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||RBC Transfusions||Standard Deviation|Mean
2792194|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).|||RBC Transfusions||Standard Deviation|Mean
2792195|NCT00577083|Secondary|Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.|During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.|after 2nd colonoscopy was completed in 24hrs|Patients aged 50 years or older who were able to give informed consent and were scheduled for elective colonoscopy at IUH were eligible for enrollment. Exclusion criteria were American Society of Anesthesiologists class III or higher, previous surgical resection of the colon or rectum, inflammatory bowel disease, and current use of anticoagulants.|||Minutes||Standard Error|Mean
2792196|NCT00577083|Primary|Number of Adenomas|Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.|after the second colonoscopy is completed||||First Colonoscopy number of adenomas|||Number
2792197|NCT00577031|Secondary|European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score|"Quality of life (QoL) assessments were used to derive pre-specified QoL scores according to the QoL manual EQ-5D-3 Level (3L) user guide for instrument version 4.0. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The visual analog scale (VAS) component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The overall health score absolute changes were calculated for each participant as follows: (score at the end of treatment minus score at baseline). EQ-5D health states were converted into EQ-5D-3L raw index value by applying the scoring algorithm based on the European EQ-net VAS set. The raw index was chosen instead of rescaled index, since the questionnaire was used in order to obtain a quality of life assessment. The raw index scores ranged from 0 (worst health state) to 100 (best health state)."|Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 years|ITT population, only participants who had EQ-5D-3L scores for both baseline and last visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
2792198|NCT00577031|Secondary|Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status|"The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.~The K-Ras and/or the B-Raf gene mutation status of participants was evaluated by the central laboratory using tumor samples. Wild-type participants did not have a mutation in either gene."|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population; only participants with a known K-Ras and/or B-Raf gene mutation status and at least 1 post-baseline tumor assessment. Number (n) equals (=) number of participants with either wild-type or K-Ras/B-Raf gene mutation.|||percentage of participants|||Number
2792199|NCT00577031|Secondary|Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery|The percentage of participants who underwent surgery during the study period with an evaluation of their disease status after surgery. The surgery during the study period was described by reason: curative, palliative, biopsy, other, or unknown. Residual disease status after surgery was described as: no residual disease due to radical surgery, presence of residual disease, unknown or not applicable.|At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 years|The 52 participant subpopulation of the ITT population who underwent surgery during the time period of the study.|||percentage of participants|||Number
2792200|NCT00577031|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive. Median overall survival was estimated using the Kaplan-Meier method.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.|||months||95% Confidence Interval|Median
2792201|NCT00577031|Secondary|Overall Survival: Percentage of Participants That Died Due to Any Cause|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.|||percentage of participants|||Number
2792202|NCT00577031|Secondary|Time to Treatment Failure|Time to treatment-failure was defined as the time from the first day of treatment to discontinuation of treatment for any reason, including: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). For participants who did not experience a qualifying event, their data were censored at the earlier of either the date of last tumour assessment or the date of the last intake of study medication. Median time to treatment-failure was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.|||months||95% Confidence Interval|Median
2792203|NCT00577031|Secondary|Percentage of Participants With Treatment Failure|Treatment-failure was defined as discontinuation of treatment for any reason, including the following qualifying events: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.|||percentage of participants|||Number
2792204|NCT00577031|Secondary|Duration of Stable Response|For participants with a best overall response of CR, PR, or SD during first line treatment, the duration of stable response was measured from the time that the criteria for CR, PR, or SD (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of stable response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.|||months||95% Confidence Interval|Median
2792205|NCT00577031|Secondary|Percentage of Participants With a Stable Response During First Line Treatment|Stable response defined as participants with a best overall response of CR, PR, or stable disease (SD), defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.|||percentage of participants|||Number
2792206|NCT00577031|Secondary|Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event|For participants with a best overall response of CR or PR, the duration of overall response was measured from the time that the criteria for CR or PR (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of overall response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.|||months||95% Confidence Interval|Median
2792207|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment|CR and PR were defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.|||percentage of participants|||Number
2792208|NCT00577031|Secondary|Time to CR or PR Overall Response - Time to Event|Time to overall response (CR or PR) was calculated as the time between the date of start of treatment until first documented response (CR or PR defined per RECIST v1.0). Participants who did not achieve CR or PR were censored at the date of progression, death, or at last adequate tumor assessment date. Median time to CR or PR overall response was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.|||months||95% Confidence Interval|Median
2792209|NCT00577031|Primary|PFS: Time to Event|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|ITT population.|||months||95% Confidence Interval|Median
2792210|NCT00577031|Secondary|Percentage of Participants With a CR or PR Among Participants in the ITT Population|CR and PR were defined using RECIST v1.0. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.|||percentage of participants|||Number
2792211|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment|The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|Subset of participants in the ITT population who had at least 1 post-baseline tumor assessment.|||percentage of participants|||Number
2792224|NCT00576901|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Day 1 of Cycles 1-6|ER population|||percentage of participants|||Number
2792212|NCT00577031|Primary|Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|Intent-to-treat (ITT) population: all enrolled participants who received at least 1 dose of all study medications and had at least 1 measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria.|||percentage of participants|||Number
2792213|NCT00577005|Secondary|Cocaine Craving|Weekly cocaine craving was measure at intake and weekly after with the Visual Analog Scale (VAS) of the Cocaine Selective Severity Assessment. The VAS measures the intensity of cocaine craving with a scale from 0 (No desire at all) to 7 (Unable to resist), and frequency of cocaine craving in the previous 24 hours with a scale from 0 ( never) to 7 ( all the time). The scale is totaled for a maximum number of 14, the minimum is 0. (Kampman et al., 1998; Mulvaney et al., 1999).|Weekly from baseline to week 12|Intent to treat sample|||units on a scale||Standard Error|Mean
2792214|NCT00577005|Secondary|Treatment Retention|Weekly from week 1 to 13|Week 13|Intent-treat-sample (ITT) that was inducted onto methadone and received one dose of study medication on week 2.|||participants|||Number
2792215|NCT00577005|Secondary|Change of Thrice Weekly Opioid Free Urine Toxicology From Week 1 to 13|The secondary outcome variable was the change from baseline to week 13 of the thrice weekly opioid-free urine scores. In this repeated ordinal variable, 0 represented all 3 urines samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urines samples submitted by the subjects were negative for opioids excluding methadone. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data summarized by number of participants who were had opioid free urine samples (score 2) per week by group.|Weekly from baseline to week 12|The intent-to-treat (ITT) sample were the 28 subjects were randomized and received one dose of study medication.|||participants with opioid free urine|||Number
2792216|NCT00577005|Primary|Change of Thrice Weekly Cocaine Free Urine Toxicology From Week 1 to 13|The primary outcome variable was the change from baseline to week 13 of the thrice weekly cocaine-free urine scores. In this repeated ordinal variable, 0 represented all 3 urine samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urine samples submitted by the subjects were negative for cocaine. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal data. Data is summarized as number of participant that were cocaine free urine (score 2) per week by group.|Weekly from baseline to week 12|The intent-to-treat (ITT) sample were the 28 subjects were randomized and received one dose of study medication.|||participants that were cocaine free|||Number
2792217|NCT00576927|Other Pre-specified|Daytime Sleep|As measured by percent of daytime behavioral observations observed asleep|All Assessment Phases, up to one week||||percentage of daytime sleep observations||Standard Deviation|Mean
2792218|NCT00576927|Secondary|Daytime Engagement Status|Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted.|All Assessment Phases, up to one week||||percentage of engaged observations||Standard Deviation|Mean
2792219|NCT00576927|Primary|Number of Participants Meeting Good Sleep Latency Criteria|"Sleep Latency Criteria for Good Latency measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm.~Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week."|All assessment periods, up to one week|30 subjects enrolled into the behavioral intervention. 4 subjects responded to the sleep hygiene intervention (SHI) arm and completed the study. 3 subjects were excluded for various reasons from the SHI arm. 23 subjects continued onto the placebo/SHI. 1 subject withdrew from that arm. From there,11 subjects received drug and 11 remained on placebo|||participants|||Number
2792220|NCT00576927|Secondary|Sleep Efficiency|% of time asleep holding time in bed constant (averaged over 3-5 nights)|All Assessment Phases, up to one week|Per protocol -- intention to treat - ITT - last carried forward.|||percentage of sleep||Standard Deviation|Mean
2792221|NCT00576901|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.|Following Cycle 6|ITT population.|||percentage of participants|||Number
2792222|NCT00576901|Secondary|Overall Survival|Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival is not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.||||||
2792223|NCT00576901|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival was not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.||||||
2792755|NCT00572533|Post-Hoc|Subjects Receiving Transfusion|Number of Subjects receiving Transfusion|12 months|Intent-To-Treat, Missing Data Excluded|||Participants|||Number
2792225|NCT00576901|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)|Evaluable Response (ER) Population: study-eligible participants who completed at least 2 treatment cycles; had lesions evaluated using the same technique at baseline and at least once after receiving the second treatment cycle; and had no major protocol deviation.|||percentage of participants|||Number
2792226|NCT00576836|Secondary|Thymus Allograft Biopsy|Evidence, on biopsy of the thymus tissue implanted in the recipient muscle, that shows the development of new T cells.|2 to 3 months post-CTTI|cDGA participants who had a biopsy on the thymus tissue implanted.The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||Participants|||Count of Participants
2792227|NCT00576836|Secondary|Immune Reconstitution Efficacy - Response to Mitogens|The development of a T cell proliferative response to the mitogen phytohemagglutinin.|1 year post-CTTI|Data were only included on cDGA participants for the 1 year time point if testing was performed in the relevant time period. The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||counts per minute (cpm)||Inter-Quartile Range|Median
2792228|NCT00576836|Secondary|Immune Reconstitution Efficacy - Naive CD8 T Cells|The development of naïve CD8 T cells at one year as measured using flow cytometry.|1 year post-CTTI|Data were only included on cDGA participants for the 1 year time point if a T cell count was performed in the relevant time period. The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||cells/mm3||Inter-Quartile Range|Median
2792229|NCT00576836|Secondary|Immune Reconstitution Efficacy - Naive CD4 T Cells|The development of naive CD4 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA participants for the 1 year time point if a T cell count was performed in the relevant time period. The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||cells/mm3||Inter-Quartile Range|Median
2792230|NCT00576836|Secondary|Immune Reconstitution Efficacy - CD8 T Cells|The development of total CD8 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA participants for the 1 year time point if a CD8 T cell count was performed in the relevant time period. The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||cells/mm3||Inter-Quartile Range|Median
2792231|NCT00576836|Secondary|Immune Reconstitution Efficacy - CD4 T Cells|The development of total CD4 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA participants for the 1 year time point if a CD4 T cell count was performed in the relevant time period. The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||cells/mm3||Inter-Quartile Range|Median
2792232|NCT00576836|Secondary|Immune Reconstitution Efficacy - CD3 T Cells|The development of total CD3 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA participants for the 1 year time point if a CD3 T cell count was performed in the relevant time period. The study was designed to assess survival. No subjects were enrolled into Arm 1. No subjects received a parathyroid transplant. Therefore, results are reported for Arm 2 only.|||cells/mm3||Inter-Quartile Range|Median
2792233|NCT00576836|Secondary|Survival at 2 Years Post-CTTI|Survival at 2 years post CTTI was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.|2 years post-CTTI|Analysis includes cDGA participants. After CTTI, 1 subject was determined to have SCID and not cDGA. Efficacy analysis as reported is on cDGA, without the SCID subject as CTTI cannot lead to T cell development in SCID. No subjects were enrolled into Arm 1. No subjects received parathyroid transplant. Therefore, results are reported for Arm 2 only.|||% of participants who survive to 2 years||97.5% Confidence Interval|Number
2792234|NCT00576836|Primary|Survival at 1 Year Post-CTTI|Survival at 1 year post CTTI was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.|1 year post-CTTI|Analysis includes cDGA participants. After CTTI, 1 subject was determined to have SCID and not cDGA. Efficacy analysis as reported is on cDGA, without the SCID subject as CTTI cannot lead to T cell development in SCID. No subjects were enrolled into Arm 1. No subjects received parathyroid transplant. Therefore, results are reported for Arm 2 only.|||% of participants who survive to 1 year||95% Confidence Interval|Number
2792235|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes||52 weeks (efficacy and extension study phases)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received).|||participants|||Number
2792236|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.~A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (efficacy study phase)|The analysis was performed on the ITT population (i.e. all included patients who received at least one dose of Alfuzosin).|||participants|||Number
2792613|NCT00573794|Primary|Mayo Score: Change From Baseline Over Time|The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792237|NCT00576823|Primary|Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis|"Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point.~'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney.~'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney."|baseline and 12 weeks (efficacy study phase)|The analysis was on the intent-to-treat (ITT) population (i.e. all included patients who received at least one dose of Alfuzosin) excluding the patients who didn't have baseline SFU grade. Patients without post-baseline SFU grade before Week 12 were included as non-responders.|||participants|||Number
2792238|NCT00576758|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)|Blood was collected on Day 1 pre-infusion, during the safety follow-up for those patients who did not enter the Extension period and 6 months after the last infusion of the Extension Period if applicable. Blood was sent to a central laboratory and was tested for anti-obinutuzumab antibodies using a validated enzyme-linked immunosorbent assay (ELISA). HAHA samples were not collected for participants randomized to the rituximab arm.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received study drug.|||Participants|||Number
2792239|NCT00576758|Secondary|Number of Participants With Human Anti-Chimeric Antibodies (HACA)|Blood was collected on Day 1 and was sent to a central laboratory for analysis of human anti-chimeric antibodies (anti-rituximab antibodies) using a validated enzyme-linked immunosorbent assay (ELISA). HACA samples were not collected for participants randomized to the rituximab arm.|Day 1|Participants from the Safety Population, all randomized participants who received study drug, who had samples available for HACA analysis.|||Participants|||Number
2792240|NCT00576758|Secondary|Number of Participants With Infusion Related Reactions|Infusion Related Reactions were AEs that occurred during the infusion or within 24 hours of the infusion.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received at least once dose of study drug.|||Participants|||Number
2792241|NCT00576758|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory result), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) [Includes all AEs reported 28 days after last dose and all Related SAEs regardless of time of last dose.]|Safety Population included all randomized participants who received study drug.|||Participants|||Number
2792242|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as the time point when the CD-19 values return to ≥ 50% of baseline levels. The number of participants with B-cell recovery from End of Induction (treatment) Phase to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) or Recovery without PD. PD required one of the following: 50 % increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50 % increase in the longest diameter of any previous site of lymphadenopathy, 50 % increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|End of last dose + 6 Months Follow-Up|Participants from the Safety Population, all randomized participants who received study drug, with previous B-Cell Depletion and B-Cell assessment at 6 Month Follow-up.|||Participants|||Number
2792243|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Depletion|Blood was collected and sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry at the end of the induction period. B-cell depletion was defined as a CD19 result 5 % of the Baseline value after at least one dose of study drug was administered.|Day 22|Participants from the Safety Population, all randomized participants who received study drug, with data available for analysis.|||Participants|||Number
2792244|NCT00576758|Secondary|Obinutuzumab Trough Serum Concentration (Ctrough)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Ctrough was calculated in micrograms/milliliter (μg/mL).|Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||μg/mL||Standard Deviation|Mean
2792245|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve Between Dosing Interval (AUCtau)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUCtau was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||day*μg/mL||Standard Deviation|Mean
2792246|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Volume of Distribution at Steady-State (Vss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss was calculated in liters (L).|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||Liter||Standard Deviation|Mean
2792247|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Clearance at Steady-State (CLss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLsst was calculated in milliliter/day (mL/day)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||mL/day||Standard Deviation|Mean
2792248|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve (AUClast)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUClast was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||day*μg/mL||Standard Deviation|Mean
2792249|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 1, 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was calculated in micrograms/milliliter (μg/mL).|Day 1 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours post-infusion), Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||μg/mL||Standard Deviation|Mean
2792250|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for Pharmacokinetic (PK) Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Terminal Half-Life was calculated in days.|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.|||days||Standard Deviation|Mean
2792251|NCT00576758|Secondary|Duration of Response|"Duration of Response was defined as the date the response, either Complete Response (CR) or Partial Response (PR), was first recorded until the date of Disease Progression or death due to any cause. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.~Disease Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants with follicular NHL at the time of diagnosis N=75/74] with response. Patients with no documented progression after CR or PR will be censored at the last tumor assessment. If no assessment available patients will be censored at the first study drug.|||Months||95% Confidence Interval|Median
2792252|NCT00576758|Secondary|Percentage of Participants With Event Free Survival (EFS) Events|"Percentage of participants with Event Free Events: disease progression/relapse, death, or start of a new anti-leukemic therapy.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants|||Number
2792253|NCT00576758|Secondary|Event Free Survival|"Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no EFS event occurred, EFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.|||Days||95% Confidence Interval|Median
2792254|NCT00576758|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events|"The percentage of participants with progression, relapse, or death events from any cause as assessed by the Investigator.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants) with follicular non-Hodgkin's lymphoma at the time of diagnosis. If event did not occur, PFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.|||Percentage of participants|||Number
2792255|NCT00576758|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the Investigator.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no PFS even occurred, PFS was censored at the date of the last tumor assessment. If no tumor assessment was available patient was censored at the date of the first study drug administration.|||Days||95% Confidence Interval|Median
2792256|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
2792257|NCT00576758|Secondary|Number of Participants With Improved Overall Response During the Extended Treatment Period|Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis who received treatment in the extension period.|||Participants|||Number
2792258|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
2792259|NCT00576758|Secondary|Percentage of Participants With Partial Response (PR) at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
2792260|NCT00576758|Secondary|Percentage of Participants With Complete Response at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR is defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. All lymph nodes and nodal masses must have regressed to normal size. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants||95% Confidence Interval|Number
2792271|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.|From Week 29 to Week 36 (EEP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||participants|||Number
2792756|NCT00572533|Secondary|ESA Dose|Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)|12 months|Intent-to-Treat Analysis, Missing Data Excluded|||IU||Standard Deviation|Mean
2792757|NCT00572533|Secondary|Mean Hb|Mean Hemoglobin concentration over follow-up period|12 months|Intent-To-Treat Analysis, Missing Data Excluded|||g/dL||Standard Deviation|Mean
2792261|NCT00576758|Primary|Percentage of Participants With Overall Response At the End of Induction Period|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff: 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.|||Percentage of participants|||Number
2792262|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Months|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.|||units on a scale||Standard Deviation|Mean
2792263|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Months||Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.|||mg/dL||Standard Deviation|Mean
2792264|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Weeks|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 weeks|All randomized subjects with >=1 dose of study medication and fasting glucose and insulin at baseline and at >=1 postbaseline time point. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period. Means are adjusted for baseline weight (<45 kg, >=45 kg) and baseline IR.|||units on a scale||95% Confidence Interval|Least Squares Mean
2792265|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Weeks||Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline fasting laboratory samples. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||mg/dL||Standard Deviation|Mean
2792266|NCT00576732|Secondary|Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.|"Investigator impression of change over time from double-blind baseline on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)."|6 weeks|All randomized subjects with at least one dose of study medication and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||participants|||Number
2792267|NCT00576732|Secondary|Change in Clinical Global Impression Severity (CGI-S)|"Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1=not ill, 2=very mild, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe)."|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||units on a scale||Standard Deviation|Mean
2792268|NCT00576732|Secondary|Number of Participants Who Had at Least 25% Improvement in ABC-I|ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).|6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||participants|||Number
2792269|NCT00576732|Primary|Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale|Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).|||units on a scale||Standard Deviation|Mean
2792270|NCT00576693|Primary|Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.|Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.|Mean length of follow-up was 2.4 years|All patients enrolled in the study were included in the primary outcome analysis.|||participants|||Number
2792272|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Transferrin Saturation|The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||percentage of saturation||Standard Deviation|Mean
2792273|NCT00576628|Secondary|Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count|The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||10^9 cells/liter||Standard Deviation|Mean
2792274|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Ferritin Concentration|The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||micrograms per liter||Standard Deviation|Mean
2792275|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration|The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||grams per liter||Standard Deviation|Mean
2792276|NCT00576628|Secondary|Mean Values of Laboratory Parameter: C Reactive Protein|The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.|||milligrams per liter||Standard Deviation|Mean
2792277|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Serum Creatinine|The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.|Baseline (Week 0), and Week 32|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||micromoles/liter||Standard Deviation|Mean
2792278|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity|The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||micromoles/liter||Standard Deviation|Mean
2792279|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration|The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."|||millimoles per litre||Standard Deviation|Mean
2792280|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.|||fraction||Standard Deviation|Mean
2792758|NCT00572533|Secondary|Percent Hb > 12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.|12 months|Intent-To-Treat, Missed Data Excluded|||Percent|||Number
2792759|NCT00572533|Post-Hoc|Transfusion Events|Number of Transfusion Events|12 months|Intent-To-Treat, Missing Data Excluded|||Events|||Number
2792281|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hb Concentration|The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.|||g/dL||Standard Deviation|Mean
2792282|NCT00576628|Secondary|Number of Participants With Red Blood Cells Transfusions.|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.|Up to Week 52|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.|||participants|||Number
2792283|NCT00576628|Secondary|Time to Achievement of Response During the Efficacy Evaluation Period|The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||days||Standard Deviation|Mean
2792284|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|From Week 0 to Week 28 (DTP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||participants|||Number
2792285|NCT00576628|Secondary|Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period|The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||days||Standard Deviation|Mean
2792286|NCT00576628|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP|Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||percentage of participants||95% Confidence Interval|Number
2792287|NCT00576628|Primary|Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period|The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.|Baseline (Week 0) and from Week 29 to Week 36|The primary analysis was performed on per protocol (PP) population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.|||g/dL||Standard Deviation|Mean
2792288|NCT00576576|Secondary|Change in Fibrous Plaque Volume|Change in fibrous plaque volume between baseline and follow-up. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set|||mm^3||Inter-Quartile Range|Median
2792289|NCT00576576|Secondary|Change in Atheroma Volume|Change in atheroma volume between baseline and follow-up is reported. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set|||mm^3||Inter-Quartile Range|Median
2792290|NCT00576576|Primary|Change in Necrotic Core Volume|Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).|6 months|All enrolled patients with complete data set|||mm^2||Standard Deviation|Mean
2792291|NCT00576524|Secondary|Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.||6 weeks|Data not analyzed - study closed due to lack of recruitment||||||
2792292|NCT00576524|Secondary|Extra Days to Achieve Target Dry Weight|Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight|6 weeks|Data not analyzed - study closed due to lack of recruitment||||||
2792293|NCT00576524|Primary|Fluid Removal|Fluid removed as percentage of dry body weight.|6 weeks|Data not analyzed - study closed due to lack of recruitment||||||
2792294|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Interference Score have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
2792295|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Ink Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
2792296|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
2792297|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Word Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
2792298|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Long Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated Z Score||Standard Error|Mean
2792299|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Short Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated Z Score||Standard Error|Mean
2792300|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Trials 1-5 have a mean T Score of 50 and Standard Deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated T Score||Standard Error|Mean
2792301|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Beta (Risk Taking).|Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D' and β are derived variables from signal detection theory. β is a measure of response tendency; higher scores indicate a more conservative response pattern. β was calculated using the formula = -d'*.5*(NORMSINV(hits)-NORMSINV(false alarms)). In the case where the false alarm rate = 0 or the hit rate = 1.0, we used the standard correction of 1/2N and 1- 1/2N, respectively.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
2792760|NCT00572533|Secondary|Percent Hb < 10 g/dL|Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded|||Percent|||Number
2792302|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d' (Sensitivity).|Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D' and β are derived variables from signal detection theory. D' is a measure of sensitivity of a person to the signal or target; a higher score is indicative of better performance or better sustained attention. D' was calculated as z(hit) - z(commission). Z-scores were calculated using the NORMSINV function in Microsoft Excel.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
2792303|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Hit Reaction Time.|Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Hit reaction time is average reaction time in milliseconds for all correct responses when targets were presented. There is no pre-defined range for reaction time; higher score is indicative of slower processing speed.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
2792304|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.|Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Commission errors are the raw score for the numbers of nontargets presented where the subject incorrectly responded. Accordingly, the range for this variable is 0-6 with a higher score indicative of worse performance or impulsivity.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
2792305|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Omission Errors.|Change in raw scores for the shortened version of the Conner's CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners' CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners' CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Omission errors are the raw score for the number of targets presented where the subject did not respond. Accordingly, the range for this variable is 0-54 with a higher score indicative of worse performance or problems with sustained attention.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.|||Estimated raw score||Standard Error|Mean
2792306|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
2792325|NCT00576472|Primary|Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls|To compare the white matter volume of patients by treatment intensity groups (mild, moderate, and high) and sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had an evaluable MRI image.|||percentage||95% Confidence Interval|Mean
2792307|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) - Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
2792308|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
2792309|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) - Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated Standard Score||Standard Error|Mean
2792310|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) ADHD Index.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
2792311|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Hyperactivity Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
2792350|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 10 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792351|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 6 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application start|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792312|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
2792313|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) ADHD Index.|The Conners' Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
2792314|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Hyperactivity Scale.|The Conners' Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
2792315|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners' Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.|The Conners' Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.|||Estimated T Score||Standard Error|Mean
2792316|NCT00576472|Secondary|Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were done weekly during the 3-week Home Crossover Period with the best response being used as the measurement for the test.|weekly during 3-week home crossover phase|There were 122 patients treated in the home crossover period. Some patients had missing treatments and outcome assessments. A crossover design was used for better efficiency of test and better precision of estimation.|||T score||95% Confidence Interval|Mean
2792317|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Math Composite score assesses the child's ability to solve calculation problems (Numerical Operations) and solve applied, word problems (Math Reasoning). Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score System. 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792761|NCT00572533|Primary|Percent Hb 10-12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded|||Percent|||Number
2792318|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Spelling score assesses the child's ability to spell words to dictation. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score System and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792319|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Reading Composite consists of Basic Reading (single word reading) and Reading Comprehension. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) REading: Composite Standard Score questionnaire and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792320|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)|The Social Skills Rating System- Parent Version (SSRS-P) is a parent rating scale of social behaviors in reference to typically developing children. Thirty eight questions are rated 0 (Never) to 3 (very often). The social skills score is norm-referenced with a mean of 100±15 where a higher score is indicative of better skills. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System (SSRS-P) and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792321|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Score Questionnaire and 68 were screened at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792322|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Score Questionnaire and 68 were screen at completion. 68 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792323|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screened at completion. 47 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2792324|NCT00576472|Primary|Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Methylphenidate (MPH) Home Maintenance Phase(baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screen at completion. 47 patients were analyzed.|||T-score||95% Confidence Interval|Mean
2795643|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients|||Participants|||Number
2792326|NCT00576472|Primary|Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors|To compare the white matter volume of Acute Lymphoblastic Leukemia (ALL) patients with those of patients with malignant brain tumors using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images.|||percentage||95% Confidence Interval|Mean
2792327|NCT00576472|Primary|Brain White Matter Volume for Patients Versus Sibling Controls|To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had evaluable MRI images.|||percentage||95% Confidence Interval|Mean
2792328|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792329|NCT00576420|Secondary|Laboratory Values Over Time: International Normalized Ratio (INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||ratio||Full Range|Median
2792330|NCT00576420|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||seconds||Full Range|Median
2792331|NCT00576420|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||U/L||Full Range|Median
2792332|NCT00576420|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||U/L||Full Range|Median
2792333|NCT00576420|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||mg/dL||Full Range|Median
2792334|NCT00576420|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||x10^3/µl||Full Range|Median
2792335|NCT00576420|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||x10^3/µl||Full Range|Median
2792336|NCT00576420|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||x10^6/µl||Full Range|Median
2792337|NCT00576420|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percentage of red blood cells in blood||Full Range|Median
2792338|NCT00576420|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Set|||g/dl||Full Range|Median
2792339|NCT00576420|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percent change||Full Range|Median
2792340|NCT00576420|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||Breaths/ minute||Full Range|Median
2792341|NCT00576420|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percent change||Full Range|Median
2792342|NCT00576420|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||Heart beats/ minute||Full Range|Median
2792343|NCT00576420|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set|||percent change||Full Range|Median
2792344|NCT00576420|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||mm Hg||Full Range|Median
2792345|NCT00576420|Secondary|Percentage of Participants With Infections at the Surgical Site||Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set|||percentage of participants||90% Confidence Interval|Number
2792346|NCT00576420|Secondary|Percentage of Participants With Graft Occlusions|Determined clinically and defined as absence of blood flow through the graft.|Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set|||percentage of participants||90% Confidence Interval|Number
2792347|NCT00576420|Secondary|Percentage of Participants With Any Transfusion Requirement|Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)|Intraoperative (day 0) through day 30 ± 5|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792348|NCT00576420|Secondary|Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line|Any rebleeding requiring surgical reexploration|Postoperative through day 30 ± 5|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792349|NCT00576420|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792352|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792353|NCT00576420|Primary|90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line|"Hemostasis at the study suture line must be maintained until closure of the surgical wound.~Participants were considered treatment failures if they met any of the following conditions:~Did not achieve hemostasis at 4 minutes~Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period~Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||90% Confidence Interval|Number
2792354|NCT00576420|Primary|Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.|"Hemostasis at the study suture line must be maintained.~Participants were considered treatment failures if they met any of the following conditions:~Did not achieve hemostasis at 4 minutes~Required additional hemostatic treatment during the first 4 minutes of the observation period~Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants|||Number
2792355|NCT00576407|Secondary|Thymus Allograft Biopsy|Evidence, on biopsy of the thymus tissue implanted in muscle, that shows the development of new T cells.|2 to 3 months post-CTTI|Data were only included on cDGA and FoxN1 participants if the participant had a biopsy of the thymus tissue implanted.|||Participants|||Count of Participants
2792356|NCT00576407|Secondary|Immune Reconstitution Efficacy - Response to Mitogens|The development of a T cell proliferative response to the mitogen phytohemagglutinin.|1 year post-CTTI|Data were only included on cDGA and FoxN1 participants for the 1 year time point if testing was performed in the relevant time period.|||counts/minute (cpm)||Full Range|Median
2792357|NCT00576407|Secondary|Immune Reconstitution Efficacy - Naive CD8 T Cells|The development of naive CD8 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA and FoxN1 participants for the 1 year time point if a T cell count was performed in the relevant time period.|||cells/mm3||Full Range|Median
2792358|NCT00576407|Secondary|Immune Reconstitution Efficacy - Naive CD4 T Cells|The development of naive CD4 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA and FoxN1 participants for the 1 year time point if a T cell count was performed in the relevant time period.|||cells/mm3||Full Range|Median
2792359|NCT00576407|Secondary|Immune Reconstitution Efficacy - Total CD8 T Cells|The development of total CD8 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA and FoxN1 participants for the 1 year time point if a CD8 T cell count was performed in the relevant time period.|||cells/mm3||Full Range|Median
2792360|NCT00576407|Secondary|Immune Reconstitution Efficacy - Total CD4 T Cells|The development of total CD4 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA and FoxN1 participants for the 1 year time point if a CD4 T cell count was performed in the relevant time period.|||cells/mm3||Full Range|Median
2792361|NCT00576407|Secondary|Immune Reconstitution Efficacy - Total CD3 T Cells|The development of total CD3 T cells at one year as measured using flow cytometry|1 year post-CTTI|Data were only included on cDGA and FoxN1 participants for the 1 year time point if a CD3 T cell count was performed in the relevant time period.|||cells/mm3||Full Range|Median
2792362|NCT00576407|Secondary|Survival at 2 Years Post-CTTI|Survival at 2 years post CTTI was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.|2 years post-CTTI|Of the 26 participants, 2 subjects did not have cDGA (1 SCID and 1 FoxN1) and underwent CTTI as enrollment exceptions. The FoxN1 participant is included in the efficacy analysis, thus n=25. The SCID participant is not included in the efficacy analysis as CTTI cannot lead to T cell development in SCID.|||% of participants who survive to 2 years||95% Confidence Interval|Number
2792363|NCT00576407|Primary|Survival at 1 Year Post-Cultured Thymus Tissue Implantation (CTTI)|Survival at 1 year post CTTI was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.|1 year post-CTTI|Of the 26 participants, 2 subjects did not have cDGA (1 SCID and 1 FoxN1) and underwent CTTI as enrollment exceptions. The FoxN1 participant is included in the efficacy analysis, thus n=25. The SCID participant is not included in the efficacy analysis as CTTI cannot lead to T cell development in SCID.|||% of participants who survive to 1 year||95% Confidence Interval|Number
2792364|NCT00576381|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs)|Based on an estimated inter-subject variability of 50% for clearance, a sample size of 32 evaluable subjects will be sufficient to detect an 18% difference (alpha 0.05, power 0.9) in the clearance in this population (38 + 18 L/hr) versus that previously reported in the adult population (46 L/hr).|||mL/min||Standard Error|Least Squares Mean
2792365|NCT00576316|Secondary|Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants|||scores on a scale||Standard Deviation|Mean
2792366|NCT00576316|Primary|Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants|||Scores on a scale||Standard Deviation|Mean
2792367|NCT00576303|Secondary|Number of Participants With Red Blood Cell Transfusion|The number of participants who underwent red blood cell transfusion was reported|Up to 3 years|The safety population was defined as all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.|||number of participants|||Number
2792368|NCT00576303|Secondary|Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP|The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. . Data for the participants present at the time of assessment was used for analysis i.e. for DTP- 199, EEP-183, LTSP-178 respectively.|||number of participants|||Number
2792369|NCT00576303|Secondary|Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP|The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. Of the 199 participants, analysis was conducted on 184 participants, as 15 participants did not maintain their hemoglobin, within range of 10.5-12.5 g/dL during the EEP.|||number of days||Standard Deviation|Mean
2792370|NCT00576303|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP|All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.|||percentage of participants||95% Confidence Interval|Number
2792371|NCT00576303|Secondary|Mean Change in Hb Concentration From Baseline to the EEP|A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24|Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)|The Intent-to-Treat (ITT) population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.|||g/dL||Standard Deviation|Mean
2792372|NCT00576303|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|Per protocol (PP) population included participants except who didn’t meet inclusion criterion relative to consent, stable baseline Hb values, iron status, epoetin maintenance, and who met exclusion criterion of hemoglobinopathies/hemolysis, bleeding, >3 recorded Hb, missing drug administration, other ESA, blood transfusion during the DTP or EEP.|||percentage of participants||95% Confidence Interval|Number
2792373|NCT00576251|Primary|Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)|Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.|Day 4 - Test Of Cure (TOC) compared to Day 0||||Percent of patients|||Number
2792374|NCT00576199|Secondary|Tumor Necrosis|Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Percentage of tumor volume at Baseline||Standard Deviation|Mean
2792394|NCT00575666|Primary|Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure (CPT d prime score). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Milliseconds||Standard Deviation|Mean
2792375|NCT00576199|Secondary|Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Percentage of participants||95% Confidence Interval|Number
2792376|NCT00576199|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Months||95% Confidence Interval|Median
2792377|NCT00576199|Secondary|Time to Progression|Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Months||95% Confidence Interval|Median
2792378|NCT00576199|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Percentage of participants||95% Confidence Interval|Number
2792379|NCT00576199|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.|||Months||95% Confidence Interval|Median
2792380|NCT00576147|Primary|1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma.|"We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.~Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements."|2 years|431 Total patients enrolled; 365 total patients evaluated after 66 excluded for protocol violations; 269 Number of patients with no Intracranial Hemorrhage; 96 Number of patients with confirmed intrcranial hemorrhage; 50 Number of patients with Intracranial hemorrhage within detection limits of the device.|||Number of participants|||Number
2792381|NCT00576056|Secondary|Determine the Overall Survival in Patients Treated With This Combination Regimen|Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.|From date of initial treatment until the date of death from any cause|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).|||days||Full Range|Median
2792382|NCT00576056|Primary|Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality|Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Up to 24 months (from initial treatment through 12 months follow-up)|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).|||days||Full Range|Median
2792383|NCT00575965|Primary|Progression-Free Survival|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death based on Kaplan-Meier estimates. Patients alibe without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s). [Consensus panel criteria: Weber et al, 2003; Kimby et al, 2005].|Assessed at month 1 and 3 and thereafter every 3 months while on therapy; Assessed every 6 months for up to 2 years of follow-up. Median follow-up in this study cohort was 6 months (range 2-18 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.|||months||95% Confidence Interval|Median
2792384|NCT00575965|Primary|Objective Response Rate|Objective response is defined as achieving partial response or better on therapy based on the Consensus Panel Recommendations from the 2nd and 3rd International Workshop on WM [Weber et al, 2003; Kimby et al, 2005]. Complete Response (CR): Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. Partial Response (PR): a >=50% reduction from baseline in the SM IgM concentration. Minor Response (MR): >=25%, but a <50% reduction of SM IgM from baseline.|Assessed at month 1 and 3 and thereafter every 3 months while on therapy. Median duration on treatment was 6 months (range 1-24 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.|||proportion of patients|||Number
2792385|NCT00575887|Primary|Progression-free Survival at 6-months||Until progression||||percentage of participants|||Number
2792386|NCT00575666|Primary|Psychopathology- QLS Total|Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792387|NCT00575666|Primary|Psychopathology- CDSS Total|Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792388|NCT00575666|Primary|Psychopathology- SANS Total|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792389|NCT00575666|Primary|Psychopathology- PANSS General Psychopathology|General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792390|NCT00575666|Primary|Psychopathology- PANSS Negative|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792391|NCT00575666|Primary|Psychopathology- PANSS Positive|Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792392|NCT00575666|Primary|Psychopathology- PANSS Total|Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.|||units on a scale||Standard Deviation|Mean
2792393|NCT00575666|Primary|Cognitive Function- CPT False-alarm Rate (Proportion)|Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Proportion of total hits||Standard Deviation|Mean
2792879|NCT00571038|Secondary|Change in Weight|Mean/SE change in weight, measured in pounds (lbs)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||pounds||Standard Error|Mean
2792395|NCT00575666|Primary|Cognitive Function- CPT Hits Rate (Proportion)|"Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure (CPT d prime score). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Proportion of total hits||Standard Deviation|Mean
2792396|NCT00575666|Primary|Cognitive Function- CPT D Prime Score|"Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||D prime score||Standard Deviation|Mean
2792397|NCT00575666|Primary|Cognitive Function- Trails B|"Subjects completed a timed trails (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Seconds||Standard Deviation|Mean
2792398|NCT00575666|Primary|Cognitive Function- Trails A|"Subjects completed a timed trails (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Seconds||Standard Deviation|Mean
2792399|NCT00575666|Primary|Cognitive Function- HVLT Delayed Recall Total|Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Words correct||Standard Deviation|Mean
2792400|NCT00575666|Primary|Cognitive Function- HVLT Immediate Recall Total|Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Words correct||Standard Deviation|Mean
2792401|NCT00575666|Primary|Cognitive Function- Verbal Fluency|Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Words correct||Standard Deviation|Mean
2792402|NCT00575666|Primary|Cognitive Function- Digit Span Total|Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.|||Items correct||Standard Deviation|Mean
2792403|NCT00575588|Other Pre-specified|Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c|Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 104||||Percent||Standard Error|Mean
2792404|NCT00575588|Other Pre-specified|Body Weight Change From Baseline to Week 104|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin|||kilograms||Standard Error|Mean
2792405|NCT00575588|Other Pre-specified|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)|Baseline, Week 104||||Percentage of Participants|||Number
2792406|NCT00575588|Other Pre-specified|Hemoglobin A1c (HbA1c) Change From Baseline to Week 104|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin|||Percent||Standard Error|Mean
2792407|NCT00575588|Secondary|Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c|Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 52|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations|||Percent||Standard Error|Mean
2792408|NCT00575588|Secondary|Body Weight Change From Baseline to Week 52|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.|Baseline, Week 52 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement|||kilogram||Standard Error|Mean
2792409|NCT00575588|Secondary|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)|From Baseline to Week 52||||Percentage of Participants|||Number
2792410|NCT00575588|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 52|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.|Baseline to 52 Weeks|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations|||Percent||Standard Error|Mean
2792411|NCT00575510|Secondary|State Trait Anxiety Inventory (STAI)-State Scale|State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)|+ 7-30 days post-intervention|Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.|||units on a scale||Standard Deviation|Mean
2792412|NCT00575510|Primary|Adherence to Initial Follow-up (Yes/no)|Attendance at initial appointment to follow-up abnormal Pap test result|adherence rates at initial follow-up appointment, 2 weeks to 3 months||||percentage of patients who were adherent|||Number
2792413|NCT00575380|Secondary|Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)||Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312||||ug/mL||Standard Deviation|Mean
2792414|NCT00575380|Primary|Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)|Nominal time is scheduled time relative to administration of the first eye drop|Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312||||ug/g||Standard Deviation|Mean
2792415|NCT00575367|Primary|Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.||15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours|Per Protocol Population|||µg/mL||Standard Deviation|Mean
2792416|NCT00575185|Secondary|Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability|Assessing adverse events in participants to see if this drug causes more or less side effects|15 days||||participants|||Number
2792417|NCT00575185|Primary|Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline|All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline|21 days||||participants|||Number
2792418|NCT00575159|Secondary|The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period|Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK279782|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Pharmacokinetic (PK) Parameter Population comprised of all participants for whom pharmacokinetic parameter estimates were derived during any treatment period|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2792419|NCT00575159|Secondary|The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period|Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period to obtain the metabolite to parent AUC ratio for GSK189074|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2792420|NCT00575159|Secondary|Oral Clearance (CL/F) Over Period|Oral clearance is a measure of the rate at which the drug is cleared from the body via metabolism. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2792421|NCT00575159|Secondary|AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period|AUC(0-4) was defined as AUC from time zero to 4 hours post dose. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2792452|NCT00575016|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment|||Milliliters (mL) of urine||Standard Deviation|Mean
2792422|NCT00575159|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period|"Tmax was defined as the time to the maximum or peak concentration of a drug observed after multiple administration. T1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples obtained during indicated time points. T1/2 was calculated as t1/2 = ln2/λz, with λz (the terminal elimination rate-constant) estimated from log-linear regression analysis of the terminal phase of the plasma concentration-time profile.Tmax and t1/2 values for GSK189075 were presented."|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population. Only those participants available at specified time points were analyzed.|||hour||Geometric Coefficient of Variation|Geometric Mean
2792423|NCT00575159|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period|Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Geometric Means with respective Geometric Coefficient of Variation (% CV).|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2792424|NCT00575159|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUC) From Time Zero (Time of Dosing) to the Last Time Point With Measurable Analyte Concentration, AUC(0-last), AUC From Time Zero to Infinite Time, AUC(0-inf) of GSK189075 Over Period|AUC(0-last) was defined as area under the plasma concentration vs. time curve from time zero (time of dosing) to the last time point with measurable analyte concentration and AUC(0-inf) was defined as area under the plasma concentration vs. time curve from time zero to infinite time. Blood samples were collected on time points: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period.|Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period|Safety Population|||hour*nanograms per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2792425|NCT00575159|Secondary|Mean Creatinine Clearance 0-24 H|Urine samples for calculating creatinine clearance were obtained over the intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. Mean creatinine clearance over 0-24 H was presented.|Day 1 of each treatment period|Safety Population|||mL/min||Standard Deviation|Mean
2792426|NCT00575159|Secondary|Mean Total Urine Volume 0-24 H|Urine volume was recorded over intervals : 0-4h, 4-8h, 8-12h, 12-16h and 16- 24h on Day 1 for each dosing period. Mean total Urine volume over 24 hours was presented.|Day 1 of each treatment period|Safety Population|||mL||Standard Deviation|Mean
2792427|NCT00575159|Secondary|Percent of Filtered Glucose in the Urine.|Filtered glucose in the urine was assessed at indicated time points and was presented as Percentage. The 0-12h and 0-24h amounts Percent of filtered glucose in the urine were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period.|Safety Population|||Percentage||Standard Deviation|Mean
2792428|NCT00575159|Secondary|Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H)|UGE was assessed for timed subintervals up to 24h post-dose. Urine samples were collected at intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h on study days. The 0-24h amounts excreted in urine were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period|Safety Population|||mmol||Standard Deviation|Mean
2792429|NCT00575159|Secondary|Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1|AUC(0-10) was the plasma glucose weighted mean AUC for 0 to 10 h post-dosing and AUC(0-4) was the plasma glucose weighted mean AUC for 0 to 4 h post-dosing. Incremental Adjusted Weighted Means were presented.|Up to 24 hours post dose of each treatment period.|Safety Population|||mmol/L||Standard Deviation|Mean
2792430|NCT00575159|Primary|Mean of Derived Plasma Glucose Parameters|The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.|Up to 24 hours post dose of each treatment period.|Safety Population.|||mmol/L||Standard Deviation|Mean
2792431|NCT00575159|Primary|Summary of Fluid Balance|On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.|Up to 24 hours post dose of each treatment period.|Safety Population.|||Milliliters (mL)||Standard Deviation|Mean
2792432|NCT00575159|Primary|Mean Creatinine Clearance|Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.|Up to 24 hours post dose of each treatment period.|Safety Population. Only those participants available at the specified time points were analyzed.|||mL/min||Standard Deviation|Mean
2792433|NCT00575159|Primary|Summary of Urine Osmolality|Urine sample was collected at screening, Day -2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).|Day 1 (pre dose) of each treatment period|Safety Population. Only those participants available at the specified time points were analyzed.|||mmol/kg||Standard Deviation|Mean
2792434|NCT00575159|Primary|Number of Participants With Abnormal Hematology Data|Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.|Day 1 of each treatment period|Safety Population. Only those participants available at the specific time points were analyzed.|||Participants|||Count of Participants
2792453|NCT00575016|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment|||Number of Weekly Episodes||Standard Deviation|Mean
2792435|NCT00575159|Primary|Number of Participants With Abnormal Clinical Chemistry Data|Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.|Day 1 of each treatment period|Safety Population. Only those participants available at the specific time points were analyzed.|||Participants|||Count of Participants
2792436|NCT00575159|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.|Day 1 of each treatment period|Safety Population|||Participants|||Count of Participants
2792437|NCT00575159|Primary|Change From Baseline Vital Signs: Heart Rate|Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.|Day 1 of each treatment period|Safety Population|||beats/minute||Standard Deviation|Mean
2792438|NCT00575159|Primary|Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)|SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.|Day 1 of each treatment period|Safety Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2792439|NCT00575159|Primary|Number of Participants With Hypoglycemia Episodes/Events|A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits [less than 3.89 millimoles per liter (mmol/L)] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.|Day 1 of each treatment period|Safety Population|||Participants|||Count of Participants
2792440|NCT00575159|Primary|Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 6 months|Safety Population comprised of all enrolled participants who have received at least one dose of study drug were included in the safety population.|||Participants|||Count of Participants
2792441|NCT00575146|Secondary|Quality of Life||while on study treatment for up to 12 months|||||||
2792442|NCT00575146|Secondary|Ketosis||while on study treatment for up to 12 months|||||||
2792443|NCT00575146|Secondary|Frequency of Seizures||while on study treatment for up to 12 months|||||||
2792444|NCT00575146|Secondary|Overall Survival|Participants were followed until reported death or last contact until 05/2011|death/last contact, an average of about 1 year||||weeks||Full Range|Median
2792445|NCT00575146|Secondary|Progression-free-survival|measured by Macdonald-Criteria|until progression for up to 12 months|for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded|||weeks||Full Range|Median
2792446|NCT00575146|Primary|Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability|percentage of patients who discontinued diet due to intolerability|until progression for up to 12 months||||percent of participants|||Number
2792447|NCT00575094|Primary|Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.|Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|8 weeks|All patients who received at least one dose of study drug.|||participants|||Number
2792448|NCT00575042|Primary|Serum Level of Alkaline Phosphatase|We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.|1 year||||U/L||Full Range|Median
2792449|NCT00575029|Primary|Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function|the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)|weekly for up to 6 weeks||||weeks|||Number
2792450|NCT00575029|Primary|Number of Participants With Adrenal Insufficiency|Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered|stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered||||participants|||Number
2792451|NCT00575016|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment|||Centimeters of water (cm H2O)||Standard Deviation|Mean
2792563|NCT00574067|Secondary|Criminal Activity|Days of crime during the past 30 days|1 year||||days||Standard Deviation|Mean
2792564|NCT00574067|Secondary|Number of Days of Cocaine Use|Number of days used cocaine during the past 30 days.|1 year||||days||Standard Deviation|Mean
2792454|NCT00574990|Secondary|Overall Involvement in Conversation by Roles|The number of communication events was recorded on electronic notepads during each observation period. The communication events recorded included: a) physicians to physicians, to nurses, to pharmacists, and to patients; b) nurses to nurses, to physicians, to pharmacists, and to patients; and c) pharmacists to pharmacists, to physicians, to nurses, and to patients. The percentage of each of these types of verbal communications was calculated from the total number of communication events.|6 months||||percentage of role involvement in event|||Number
2792455|NCT00574990|Primary|Incident Rate for Communication Events|Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.|6 months|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.|||mean events per observation||Standard Deviation|Mean
2792456|NCT00574951|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study time of progression could not be validly collected due to the study being prematurely closed, secondary to severe neurological adverse events seen in 4 patients, and thus progression-free survival (PFS) cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE),|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated, up to 5 years|Study Analysis aborted due to severe toxicities. Estimates not calculated. Follow up for progression after coming off study was not collected in a manner that yields time to time to progression data.||||||
2792457|NCT00574951|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients|||Participants|||Count of Participants
2792458|NCT00574951|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
2792459|NCT00574951|Primary|Progression-free Survival (PFS) at 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. In this study, time of progression could not be validly collected due to the study being prematurely closed secondary to severe neurological adverse events seen in 4 patients,|CT scan or MRI every other cycle for the first 6 months|Time of progression could not be validly collected due to the study being prematurely closed due to severe neurological adverse events, thus 6-month PFS cannot be presented. For safety reasons, most patients (16/22) were taken off study drug prior to progression (or AE), and follow-up for progression after coming off study was not collected.||||||
2792460|NCT00574951|Primary|Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI every other cycle for the first 6 months; then every 3 months thereafter; and at any other time if clinically indicated up to 5 years.|Eligible and treated patients.|||Participants|||Count of Participants
2792461|NCT00574912|Primary|Maximum Glucose Infusion Rate|measuring the changes in glucose infusion rate during the 24 hour experimental period.|24 hours|12 participants in each arm|||umol/kg/min||Standard Error|Mean
2792462|NCT00574873|Secondary|Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks|"The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant.~Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets <100*10^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas).~Time to transformation was calculated as weeks = ([date of first documented occurrence of the event - date of randomization] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray's method."|192 weeks|ITT population|||Percentage of Participants||95% Confidence Interval|Number
2792565|NCT00574067|Primary|Drug Abuse Treatment Entry and Retention in the Community|entered community treatment within 10 days of release from prison (yes vs. no)|1 year||||participants|||Number
2792566|NCT00574067|Primary|Number of Days of Heroin Use|mean days used heroin during the past 30 days|1 year||||days||Standard Deviation|Mean
2792463|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks|"The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment.~Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2."|144 weeks|Subgroup of participants from ITT population who had MMR.|||Percentage of Participants||95% Confidence Interval|Number
2792464|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks|"The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment.~CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, absolute neutrophil count ≥1.0*10^9/L, platelets ≥100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly).~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CHR.|||Percentage of Participants||95% Confidence Interval|Number
2792465|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks|"The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment.~CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or <1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CCyR.|||Percentage of Participants||95% Confidence Interval|Number
2792466|NCT00574873|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Year 1|Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to [≥] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.|Year 1 (48 weeks)|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
2792467|NCT00574873|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.|Year 1 (48 weeks)|Intent-to-treat (ITT) population - included all participants who were randomized to test article.|||Percentage of Participants||95% Confidence Interval|Number
2792468|NCT00574847|Primary|Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|week 6|Subjects who completed.|||percentage of participants|||Number
2792469|NCT00574847|Secondary|Exercise Stressed-induced Myocardial Ischemia (ESIMI)|End point values adjusted for baseline values age and sex.|6 week|ITT, 7 subject excluded from analysis due to missing data.|||percentage of change||95% Confidence Interval|Number
2792470|NCT00574847|Secondary|Spielberger State-Trait Anxiety Inventory Scales (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.|6 weeks|ITT|||units on a scale||95% Confidence Interval|Mean
2792471|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Hostile Affect Sub-scale|hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.|||units on a scale||95% Confidence Interval|Mean
2792472|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Scale|Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.|||units on a scale||95% Confidence Interval|Mean
2792473|NCT00574847|Secondary|Perceived Stress Scale|Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.|6 weeks|ITT|||units on a scale||95% Confidence Interval|Mean
2792474|NCT00574847|Secondary|Platelet Serotonin Binding Affinity Kd_100|End point values adjusted for baseline values age and sex.|6 weeks|ITT, 27 subjects were excluded from analysis due to missing data.|||nM||95% Confidence Interval|Mean
2792475|NCT00574847|Secondary|5HTT, Serotonin Transporter Protein|End point values adjusted for baseline values age and sex.|week 6|ITT, 29 subjects excluded from analysis due to missing data.|||fmol/mg||95% Confidence Interval|Mean
2792567|NCT00573989|Secondary|Objective Tumor Response|Objective Tumor Response reported on participants at 1 year (complete, partial, progression, or stable response).|1 year|Data corresponds to Phase II patients.|||Participants|||Count of Participants
2792476|NCT00574847|Secondary|Mental Stress Induced Change in Heart Rate|"A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs.~Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex."|baseline, 6 weeks|ITT, 10 subjects excluded from analysis due to missing data.|||beats/minute||95% Confidence Interval|Mean
2792477|NCT00574847|Secondary|Beck Depression Inventory|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.|6 week|ITT|||units on a scale||95% Confidence Interval|Mean
2792478|NCT00574847|Secondary|Percentage of Participants With Adverse Events||Baseline to week 6||||percentage of participants|||Number
2792479|NCT00574847|Secondary|Mental Stress Induced Change of Diastolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from the analysis due to missing data.|||mm Hg||95% Confidence Interval|Mean
2792480|NCT00574847|Secondary|Mental Stress Induced Change of Systolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from analysis due to missing data.|||mm Hg||95% Confidence Interval|Mean
2792481|NCT00574847|Primary|Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|Week 6|Intent-to-treat (ITT)|||percentage of participants||95% Confidence Interval|Number
2792482|NCT00574834|Primary|Changes in Insulin Sensitivity|Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.|6 months||||mg/kg/min||Standard Error|Mean
2792483|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12-15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2792484|NCT00574795|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12 - 15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2792485|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one mone month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2792486|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2792487|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2792568|NCT00573989|Secondary|Evaluation of Biomarkers||throughout study completion, up to 2 years|Patients refused biopsy, so no data collected.||||||
2792880|NCT00571038|Secondary|Change in Diastolic Blood Pressure|Mean/SE change in diastolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||mm Hg||Standard Error|Mean
2792488|NCT00574795|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2792489|NCT00574704|Secondary|Safety and Tolerability of the Study Treatment by Collection of Adverse Events||about 30 min. at each visit|||||||
2792490|NCT00574704|Primary|Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)|"The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).~The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2."|baseline versus 2 months after baseline||||Factor of Increased Allergen Tolerance||Inter-Quartile Range|Median
2792491|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792492|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792493|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792494|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792495|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792610|NCT00573794|Secondary|Mayo Rectal Bleeding Subscore: Change From Baseline Over Time|The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792496|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792497|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792498|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792499|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792500|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2792501|NCT00574548|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2792502|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2792503|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 13vPnC; Year 1) time points.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2792504|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2792505|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2792506|NCT00574405|Secondary|Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.||12 months|||||||
2792507|NCT00574405|Secondary|Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.||12 months|||||||
2792508|NCT00574405|Secondary|Changes in Daily Insulin Requirements Over Time||12 months|||||||
2792509|NCT00574405|Secondary|Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.||12 months|||||||
2792510|NCT00574405|Primary|Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.||12 months|Per protocol|||ng/mL||Standard Deviation|Mean
2792511|NCT00574340|Primary|Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2|A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.|baseline on day 2 and ~6 hours later at end of glucose clamp period|Flow mediated dilation of the brachial artery|||percentage of change||Standard Error|Mean
2792512|NCT00574288|Secondary|Part 2: Overall Survival|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.|Approximately 3 years|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2792513|NCT00574288|Secondary|Part 2: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Time to VGPR (very good partial response) was defined as the time from the date of first dose of daratumumab to the date of initial documentation of VGPR response. The Kaplan-Meier method was used to estimate time to response.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. Here 'n' (Number of Participants Analyzed) signifies number of participants analyzed at specific time point.|||months||Standard Deviation|Mean
2792514|NCT00574288|Secondary|Part 2: Progression-Free Survival|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2792515|NCT00574288|Secondary|Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.|Up to Week 27|Subset of All-Treated Analysis Set included those who had overall response in Part 2.|||months||Full Range|Median
2792516|NCT00574288|Secondary|Part 2: Time to Progression (TTP)|TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL); urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.|Up to Week 27|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2792611|NCT00573794|Secondary|Mayo Endoscopy Subscore: Change From Baseline Over Time|The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792517|NCT00574288|Secondary|Part 1: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.|Up to Week 28|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with >= 4 mg/kg daratumumab were used for efficacy analyses and less than (<) 4 mg/kg doses were considered under the therapeutic levels.|||months||95% Confidence Interval|Median
2792518|NCT00574288|Secondary|Overall Response Rate|Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.|Up to Week 28 (for Part 1) and Week 27 (for Part 2)|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with >= 4 mg/kg daratumumab were used for efficacy analyses and less than (<) 4 mg/kg doses were considered under the therapeutic levels.|||percentage of participants||95% Confidence Interval|Number
2792519|NCT00574288|Primary|Number of Participants With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)|All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2792520|NCT00574275|Secondary|Number of Participants With Anti-drug Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.|Up to 90 days post last dose of study drug|Safety population with samples available for analysis|||participants|||Number
2792521|NCT00574275|Secondary|Safety-Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized.|The safety population included all randomized participants who were administered at least 1 dose of study medications (placebo, aflibercept, or gemcitabine). For safety analyses, participants were analyzed according to the treatment received.|||participants|||Number
2792522|NCT00574275|Secondary|Clinical Benefit|"Clinical benefit was to be assessed in all participants by time to symptom worsening (TTSW), evaluated from the time of randomization to symptom worsening, as well as by improvement in tumor related symptoms.~However, this analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, analysis for this endpoint was not performed.||||||
2792523|NCT00574275|Secondary|Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria|"Objective response (OR) included complete response [CR] and partial response [PR]. OR was to be assessed by the Investigators according to RECIST criteria, and confirmed by repeating tumor imaging at least 4 weeks after the first radiological documentation of response.~CR would reflect the disappearance of all tumor lesions and PR would reflect a defined reduction of tumor burden.~However, OR analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, this analysis was not performed.||||||
2792524|NCT00574275|Secondary|Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria|"PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors.~If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier.~Median PFS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.|||months|Participants|95% Confidence Interval|Median
2792525|NCT00574275|Primary|Overall Survival (OS)|"OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009).~OS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.|||months|Participants|95% Confidence Interval|Median
2792832|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing|Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included|up to 12 hours post dose|Intent to treat population. Limited to patients who met both criteria: a 12 percent increase in FEV1 and a 200 milliliter increase in FEV1|||minutes||Full Range|Median
2792526|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 8|Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792527|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 16|Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792528|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 12|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792529|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 8|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792530|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 4|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792531|NCT00574249|Secondary|Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 2|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792532|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 16|Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Standard Deviation|Mean
2792533|NCT00574249|Secondary|Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 16|ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
2792534|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 12|ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
2792535|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 8|ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
2792536|NCT00574249|Other Pre-specified|Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.|NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Inter-Quartile Range|Median
2792537|NCT00574249|Other Pre-specified|Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.|PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.|||percent change in score||Inter-Quartile Range|Median
2792538|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 4|ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
2792539|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 2|ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal.|||percentage of participants|||Number
2792540|NCT00574249|Secondary|Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)|PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
2792541|NCT00574249|Secondary|Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
2792542|NCT00574249|Secondary|Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)|PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
2792543|NCT00574249|Primary|Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.|||percentage of participants|||Number
2792833|NCT00571428|Secondary|Time to Onset of 15 Percent Response Within 12 Hours of Dosing|Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.|12 hours post first dose|Intent to treat population. Limited to those patients who had a 15% response.|||minutes||Full Range|Median
2792544|NCT00574236|Secondary|Time to Progression|Number of days to progression, where progression is defined as the number of days from the day of first study drug administration to the day the patient experiences an event of disease progression, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. If a patient has not experienced an event of disease progression, then the patient's data will be censored at the date of the last available evaluation. Progression-free survival will be summarized by medium time to progression.|Up to one year||||days to progression||Full Range|Median
2792545|NCT00574236|Primary|Overall Response Rate|"Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm."|Every two cycles/42 days, up to 7 months|Protocol accrued only 4 of 54 subjects, and was ultimately terminated. No data analysis was done.|||Participants|||Count of Participants
2792546|NCT00574171|Primary|Response Rate of Lapatinib/Capecitabine.||duration of study; on average 1 year||||participants|||Number
2792547|NCT00574145|Secondary|Intensity of Anxiety and Depression|Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints.|baseline and off-radiation at 5 to 7 weeks|Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks|||units on a scale||Full Range|Median
2792548|NCT00574145|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)|36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined|baseline and 6 weeks|Arm A:1 patient was accidentally notified of group assignment before final data collected, 2 patients withdrew (1 at 2 days), 1 at 5 days. )Arm B: 1 patient withdrew at 4 weeks|||units on a scale||Full Range|Median
2792549|NCT00574145|Primary|Fatigue Using the Brief Fatigue Inventory (BFI)|9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.|6 weeks|Patients who completed 5 of 8 maximum collection points. Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks|||units on a scale||Standard Deviation|Mean
2792550|NCT00574119|Secondary|Minnesota Living With Heart Failure Questionnaire.at 6 Months|The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.|6 months||||score on a scale||Inter-Quartile Range|Median
2792551|NCT00574119|Secondary|Minnesota Living With Heart Failure Questionnaire,at Baseline|The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.|baseline||||score on a scale||Inter-Quartile Range|Median
2792552|NCT00574119|Secondary|6 Minute Walk Test (6MWT) at 6 Months|6MWT assesses distance walked over 6 minutes|6 months||||meters||Inter-Quartile Range|Median
2792553|NCT00574119|Secondary|6 Minute Walk Test (6MWT) at Baseline|6MWT assesses distance walked over 6 minutes|baseline||||meters||Inter-Quartile Range|Median
2792554|NCT00574119|Primary|Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging|T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.|baseline and 6 months||||msec||Standard Deviation|Mean
2792555|NCT00574119|Primary|Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months|MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.|6 months||||MPRI||Inter-Quartile Range|Mean
2792556|NCT00574119|Primary|Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline|MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.|baseline||||MPRI||Inter-Quartile Range|Mean
2792557|NCT00574119|Primary|Left Ventricular Work-metabolic Index (WMI) at 6 Months|WMI=[left ventricular stroke work/decay rate of 11C-acetate]|6 months|12 patients completed study|||(x10^6), mL x mm Hg/m^2||Inter-Quartile Range|Median
2792558|NCT00574119|Primary|Left Ventricular Work-metabolic Index (WMI) at Baseline|WMI=[left ventricular stroke work/decay rate of 11C-acetate]|baseline|12 patients completed study|||(x10^6), mL x mm Hg/m^2||Inter-Quartile Range|Median
2792559|NCT00574080|Primary|Event Free Survival|Time from study registration until disease progression or death.|Up to 3 years 8 months|no analysis, participants either died or were withdrawn by PI. study terminated with <10% of target accrual enrolled.||||||
2792560|NCT00574067|Secondary|HIV Risk Behavior|Number of times had sex without using a condom during the past year|1 year||||times||Standard Deviation|Mean
2792561|NCT00574067|Secondary|HIV Risk Behavior Needle Sharing|Number of times shared a needle during the past year|1 year||||times||Standard Deviation|Mean
2792562|NCT00574067|Secondary|Employment Status|Number of days employed during the past year|1 year||||days||Standard Deviation|Mean
2792569|NCT00573989|Secondary|Change in Quality of Life: MDADI|The M.D. Anderson Dysphagia Inventory (MDADI) was used to assess effects of dysphagia on the quality of life of patients with head and neck cancer. It incorporates 3 domains (emotional, functional, and physical) as well as 1 global question. Each subscale with five possible responses scored on a scale of 1 to 5 (strongly agree, agree, no opinion, disagree and strongly disagree). Scores range from 0 (extremely low functioning) to 100 (higher functioning). Higher MDADI score represents better day-to-day functioning and better quality of life.|baseline and 12 months|Data not collected on all participants at 12 months. Data corresponds to Phase II patients.|||units on a scale||Standard Deviation|Mean
2792570|NCT00573989|Secondary|Change in Quality of Life: PSS-HN|The Performance Status Scale for Head & Neck Cancer Patients (PSS-HN) is s designed to evaluate performance in areas of functioning most likely affected by head and neck cancer and its treatment, specifically Normalcy of Diet, Eating in Public, and Understandability of Speech. Each subscale is rated from 0 to 100, with higher scores indicating better performance|baseline and 6 months|Data not collected for all participants.|||units on a scale||Standard Deviation|Mean
2792571|NCT00573989|Secondary|Change in Quality of Life- FACT H&N|The Functional Assessment of Cancer Therapy-Head and Neck (FACT H&N) consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain. Score range is 0-156. Higher scores denotes better outcomes|baseline and 12 months|Data not collected for all participants at 12 months. Data corresponds to Phase II patients.|||units on a scale||Standard Deviation|Mean
2792572|NCT00573989|Secondary|Evaluation of Acute and Chronic Toxicity|Evaluate acute and chronic toxicity of the combined re-irradiation with radiosensitizing drugs: Pemetrexed and Erlotinib. Adverse events with Common Toxicity Criteria grades of 4 and 5 are reported for phase I and II.|1 year||||events|||Number
2792573|NCT00573989|Secondary|Overall Survival|Overall survival of participants reported after 2 years.|1 and 2 years|Data corresponds to Phase II patients.|||Participants|||Count of Participants
2792574|NCT00573989|Secondary|Median Overall Survival|Median Overall Survival of participants reported after 2 years.|up to 5 years|Data corresponds to Phase II patients.|||years||95% Confidence Interval|Median
2792575|NCT00573989|Secondary|Median Progression Free Survival|Median Progression Free Survival of participants reported after 2 years.|2 years|Data corresponds to Phase II patients.|||years||95% Confidence Interval|Median
2792576|NCT00573989|Primary|Progression-free Survival (PFS) at 1 Year (Phase II)|Determine Progression Free Survival at 1 year defined as the percentage of patients who are alive at 1 year after beginning of their concurrent re-irradiation and chemotherapy without loco-regional progression of their disease as measured by CT scan or MRI.|1 year|Data corresponds to Phase II patients.|||Participants|||Count of Participants
2792577|NCT00573989|Primary|Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)|Dose at which 100% of participants tolerated the dose|56 Days||||mg|||Number
2792578|NCT00573937|Secondary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain.|48 hours|Due to slow accrual, the study was terminated and no data were analyzed.||||||
2792579|NCT00573937|Primary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.|Baseline, Week 4|Due to slow accrual, the study was terminated and no data were analyzed.||||||
2792580|NCT00573872|Primary|Number of Participants With Lack of Tumor Growth at Last Follow-up|Lack of tumor growth by CT or MRI at last follow-up|2 years||||Participants|||Count of Participants
2792581|NCT00573872|Primary|Assess the Acute and Late Toxicity of Spinal Radiosurgery|CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.|2 years||||events|||Number
2792582|NCT00573872|Primary|Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy|"Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as worse, stable, better, or completely resolved. In the reporting better or completely resolved indicates response to treatment."|2 years||||Participants|||Count of Participants
2792583|NCT00573859|Secondary|The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.|The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.|4 days||||scores on a scale||Full Range|Median
2792584|NCT00573859|Secondary|The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.|In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.|4 days||||errors||Standard Error|Mean
2792585|NCT00573859|Primary|The Effects of ADHD Medication Versus Placebo on Cotinine Levels|Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.|4 days|Smokers with ADHD|||ng/ml||Standard Error|Mean
2792586|NCT00573833|Other Pre-specified|Median International Prostate Symptom Total Score|Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).|week 12 reported||||scores on a scale||Full Range|Median
2795644|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients|||Participants|||Number
2792587|NCT00573833|Other Pre-specified|Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)|week 12 reported||||participants|||Number
2792588|NCT00573833|Primary|Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity|urinary and rectal toxicity-see the adverse event tables|Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)||||participants|||Number
2792589|NCT00573833|Primary|Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity|Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity|At scheduled 3 month intervals for one year||||participants|||Number
2792590|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||mg/L||Standard Deviation|Mean
2792591|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||g/L||Standard Deviation|Mean
2792592|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||mmol/L||Standard Deviation|Mean
2792593|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in ITT-1 population with both Baseline and visit values.|||μmol/L||Standard Deviation|Mean
2792594|NCT00573794|Secondary|Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||U/L||Standard Deviation|Mean
2792595|NCT00573794|Secondary|Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||cells * 10^9/L||Standard Deviation|Mean
2792596|NCT00573794|Secondary|Hematology: Mean Change From Baseline to Final Values in Hematocrit|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||Percentage of red blood cells||Standard Deviation|Mean
2792597|NCT00573794|Secondary|Hematology: Mean Change From Baseline to Final Values in Hemoglobin|Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.|Baseline (Week 0), final value (up to 5 years)|Participants in the safety analysis set with both Baseline and visit values.|||g/L||Standard Deviation|Mean
2792598|NCT00573794|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)|Safety analysis set: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2792599|NCT00573794|Secondary|Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented.|5 years|ITT-1 population|||cumulative number of utilizations|||Number
2792600|NCT00573794|Secondary|Colectomy Rate|The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.|5 years|ITT-1 population|||percentage of participants|||Number
2792612|NCT00573794|Secondary|Percentage of Participants With Remission Per Partial Mayo Score Over Time|The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore > 1.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with evaluable data at given timepoint.|||percentage of participants|||Number
2792601|NCT00573794|Secondary|WPAI:GH Activity Impairment: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent activity impaired||Standard Deviation|Mean
2792602|NCT00573794|Secondary|WPAI:GH Overall Work Impairment: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent of overall work impairment||Standard Deviation|Mean
2792603|NCT00573794|Secondary|WPAI:GH Impairment While Working: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent of work time impaired||Standard Deviation|Mean
2792604|NCT00573794|Secondary|Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time|The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||percent of work time missed||Standard Deviation|Mean
2792605|NCT00573794|Secondary|36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792606|NCT00573794|Secondary|36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792607|NCT00573794|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time|The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792608|NCT00573794|Secondary|Mayo Stool Frequency Subscore: Change From Baseline Over Time|The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792609|NCT00573794|Secondary|Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time|The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792614|NCT00573794|Primary|Partial Mayo Score: Change From Baseline Over Time|The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.|Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388|Participants in ITT-1 population with both Baseline and visit values.|||units on a scale||Standard Deviation|Mean
2792615|NCT00573768|Primary|Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.|Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)|change from baseline (on day 1) to day 5|Intent to treat (ITT)|||mm||Standard Deviation|Mean
2792616|NCT00573755|Secondary|Adverse Event|Number of participants that experienced adverse events (grade 3 and above) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Adverse events were assessed every week during first 6 weeks of therapy, every 4 weeks on months 1 to 6, every 12 weeks on months 7 and beyond and at the end of treatment.|Time from randomization to end of treatment||||participants|||Number
2792617|NCT00573755|Secondary|Duration of Response|Duration of response was defined for all patients who have achieved a confirmed response as the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.||||||
2792618|NCT00573755|Secondary|Objective Tumor Response Rate|A confirm response was defined as either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluation at least 4 weeks apart. The confirmed response rate was estimated within each treatment group by the number of confirmed responses divided by the total number of participants randomized.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.||||||
2792619|NCT00573755|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of the randomization to the date at which the patient was removed from treatment due to progression, adverse events, or refusal.|Time from randomization to treatment failure (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.||||||
2792620|NCT00573755|Secondary|Overall Survival|Survival time was defined as the time from randomization to death due to any cause.|Time from randomization to death (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome. All patients were alive at the time of their last treatment follow up.||||||
2792621|NCT00573755|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization.|Time from randomization to disease progression or death (up to 5 years)|All participants who have met the eligibility criteria, signed a consent form and were randomized to one of the two treatment groups were evaluable for the primary endpoint.|||months||95% Confidence Interval|Median
2792622|NCT00573534|Secondary|Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology.|This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies.|up to 24 weeks|The 8 subjects who took at least one dose of the medication and returned for follow up were included.|||participants|||Number
2792623|NCT00573534|Primary|Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit|The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved|up to 24 weeks|All patients who agreed to participate. Last Observation Carried Forward was used final outcome.|||participants|||Number
2792624|NCT00573508|Secondary|Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary|"The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.~Change from baseline with a lower score indicates an improvement.~End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.~Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles."|||Number of Category Events / 24 Hours||Standard Deviation|Mean
2792625|NCT00573508|Secondary|Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)|"The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).~Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.~Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles."|||TS-VAS||Standard Deviation|Mean
2792626|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.|"ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||ICIQ-FLUTSsex||Standard Deviation|Mean
2792627|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.|"ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||ICIQ-MLUTSsex||Standard Deviation|Mean
2792628|NCT00573508|Secondary|Change From Baseline in the MCUI Behavior Therapy Stratified|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.|||Number of Days||Standard Deviation|Mean
2792629|NCT00573508|Secondary|Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.|||Number of categorical items||Standard Deviation|Mean
2792630|NCT00573508|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI)|"The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.~A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.~Change from baseline is based on the ANCOVA model after adjusting baseline value & center."|Baseline and 12 Weeks|"Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles."|||Percentage of indicated parameter||Standard Deviation|Mean
2792631|NCT00573508|Secondary|Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated End of Treatment (EOT) for each sub-domain - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles."|||OAB-q HRQL Sub Domain Score||Standard Deviation|Mean
2792632|NCT00573508|Secondary|Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire|The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.|Baseline and 12 Weeks|"The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal).~A few patients who completed the BSW Questionnaire did not adequately complete the  Benefits Section and therefore are considered 'N/A' for that Section."|||Participants|||Number
2792881|NCT00571038|Primary|Change in Systolic Blood Pressure|Mean/Standard Error (SE) change in systolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||mm Hg||Standard Error|Mean
2792633|NCT00573508|Secondary|Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)|"The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems~Improvement is defined by any reduction in PPBC score.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.|||Participants|||Number
2792634|NCT00573508|Secondary|Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated as Actual Data for each time point - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||OAB-q HRQL Total Score||Standard Deviation|Mean
2792635|NCT00573508|Secondary|Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~Change is calculated as Actual Data for each timepoint - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||OAB-q Score||Standard Deviation|Mean
2792636|NCT00573508|Primary|Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment - Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants per arm is consistent for all categories / rows of the data table."|||OAB-q Score||Standard Deviation|Mean
2792637|NCT00573469|Secondary|Change in CDAI Score From Baseline to 8 Weeks|CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.|Baseline to 8 weeks||||Score on a scale||Standard Deviation|Mean
2792638|NCT00573469|Secondary|Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method|Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.|At 8 weeks||||Percentage of participants|||Number
2792639|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 4 weeks||||Participants|||Number
2792640|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 2 weeks||||Participants|||Number
2792641|NCT00573469|Primary|Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment|Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.|Baseline to 8 weeks||||Participants|||Number
2792642|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects|Subjects with MS were instructed to also record daily the pain they experienced using the PRS. After evaluating the subject's ability to comply with these requirements, the investigator determined if a caregiver should complete the study diary and assessments. Subjects rated their pain over the past 12 hours on a scale of 0 to 10 (0=none, 10=worst pain ever experienced).|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population - MS Subjects only|||Scores on a Scale||Standard Deviation|Mean
2792643|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score|The BDI-II is a 21-item self report instrument intended to assess the existence and severity of symptoms of depression, summed to give a single score. The BDI-II uses a 4-point for each item ranging from 0 to 3. A total score of 0-13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate, and 29 to 63 is severe.|Baseline and Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2792882|NCT00570960|Primary|30 Day All Cause Mortality|30 day all cause mortality|30 days||||participants|||Number
2792644|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category|The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline and Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2792645|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2792646|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|Efficacy Evaluable (EE) Population - included all subjects who were protocol adherent, defined as those who completed the Day 84 visit or the end-of-study visit within 48 hours of a discontinuation, and who took as least 80% of their scheduled doses prior to discontinuation of the study medication.|||Scores on a Scale||Standard Deviation|Mean
2792647|NCT00573443|Secondary|Mean Change From Baseline in CNS-LS Total Score by Visit|Center for Neurologic Studies-Lability Scale (CNS-LS) is an instrument for the measurement of PBA that has been validated for the use in patients with ALS and MS. It is a 7-item self-report questionnaire that measures the frequency and severity of PBA episodes, including assessments of labile laughter and labile tearfulness,and provides a score for total PBA (total score can range from 7-35). The following 5-point scoring was used: 1=Applies never, 2=Applies rarely, 3=Applies occasionally, 4=Applies frequently, 5=Applies most of the time. A score of 13 or higher may suggest PBA, and the higher the score the more severe the episodes.|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2792648|NCT00573443|Primary|PBA Episode Rate Ratio (Post/Pre), Regression Adjusted|Episodes were counted each day and recorded in a daily diary. The outcome measure is the ratio of the episode rate over the 84-day treatment period to the rate during the baseline period, adjusted for study site, and underlying disease using longitudinal negative binomial regression.|Baseline to Day 84|Intent-to-Treat (ITT) population - included all randomized subjects for the double-blind phase and all enrolled subjects for the open-label extension phase.|||Unit-free (ratio of episodes/week)||95% Confidence Interval|Least Squares Mean
2792649|NCT00573430|Secondary|Treatment-emergent Adverse Events|Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.|Baseline to 28 weeks||||Participants|||Number
2792650|NCT00573430|Secondary|Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation|GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)|28 weeks||||mL/min/1.73 m2||Standard Deviation|Mean
2792651|NCT00573430|Secondary|Inflammatory Marker (Hs-C-peptide Reactive Protein)|To evaluate how to reduce and relate with cardiovascular risk|baseline to 28 weeks||||mg/dL||Standard Deviation|Mean
2792652|NCT00573430|Secondary|Change of Systolic and Diastolic Blood Pressure From Baseline||baseline to 28 weeks||||mmHg||Standard Deviation|Mean
2792653|NCT00573430|Primary|The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks|Decrease of urinary protein/creatinine ratio means improvement of renal disease.|baseline to 28 weeks||||mg/g||Standard Deviation|Mean
2792654|NCT00573391|Primary|Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment|due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone|24 months||||Participant|||Number
2792655|NCT00573313|Secondary|Changes in Serum SAM|We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.|September 2005- June 2009|Whereas 37 subjects started the protocol, due to protocol violation, there remained 26 subjects, 13 in each group, for final analyses. Here are reported changes in AST values to represent all variables.|||nmol/liter||Full Range|Median
2792656|NCT00573313|Primary|Changes in Serum AST Levels|Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.|Week 0 to week 24|Analysis of AST values was based on numbers of participants in each group who completed the study. Analysis is pre-specified to apply only to subjects with alcoholic liver disease.|||Units per liter (U/L)||Full Range|Median
2792834|NCT00571428|Secondary|Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time.|12 hours||||liters||Standard Deviation|Mean
2792657|NCT00573287|Secondary|Number of Participants Demonstrating Improvement in Psychiatric Symptoms Using the BPRS, CGIS, and SANS at 24 Weeks|"Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on psychiatric symptoms were gathered using Brief Psychiatric Rating Scale (BPRS; weekly), Clinical Global Impressions Scale (CGIS; weekly) and Schedule for the Assessment of Negative Symptoms (SANS; bi-weekly). At the end of the study, graphs were plotted showing severity of symptoms and rated as Improved, Unchanged, or Worse by a pair of expert judges. Raters were instructed to rate the graph Improved or Worsened if it appeared to be >20% better or worse and to rate it Unchanged if there was little or no change (less than ~20%)."|24 weeks|Analysis was conducted for participants who were randomized to study medication condition and actually began treatment with study drug and had follow-up visits through week two. Three patients (two in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included in the analysis.|||participants|||Number
2792658|NCT00573287|Primary|Number of Participants Demonstrating Improvement in Substance Use|"Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use were gathered weekly using the Timeline Follow-back (TLFB) method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as Improved, Unchanged, or Worse by a pair of expert judges. Raters were instructed to rate the graph Improved or Worsened if it appeared to be >20% better or worse and to rate it Unchanged if there was little or no change (less than ~20%)."|24 weeks|Analysis was conducted for participants who were randomized to study medication condition and actually began treatment with study drug and had a follow-up visit. Two patients (one in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included in the analysis.|||participants|||Number
2792659|NCT00573261|Secondary|To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.|The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired).|baseline and at end of a 4-week intervention||||units on a scale||Standard Deviation|Mean
2792660|NCT00573261|Secondary|To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms)|baseline and at end of a 4-week intervention||||units on a scale||Standard Deviation|Mean
2792661|NCT00573261|Secondary|To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety).|baseline and at end of a 4-week intervention||||units on a scale||Standard Deviation|Mean
2792662|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention||||Ratio||Standard Deviation|Mean
2792663|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention||||Intervals more than 50 ms||Standard Deviation|Mean
2792664|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||milliseconds||Standard Deviation|Mean
2792665|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]).|baseline and at end of a 4-week intervention||||Ratio||Standard Deviation|Mean
2792666|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||Hertz (Hz)||Standard Deviation|Mean
2792762|NCT00572468|Secondary|Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.|Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy. Apoptosis was measured by calculating the percent of Ki67 cellular staining.|2 years|We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.|||Percentage of cells||95% Confidence Interval|Mean
2792667|NCT00573261|Primary|Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||Beats Per Minute||Standard Deviation|Mean
2792668|NCT00573261|Secondary|To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain.|baseline and end of 4 week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and their 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||units on a scale||Standard Deviation|Mean
2792669|NCT00573261|Primary|Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.||baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.|||mm Hg||Standard Deviation|Mean
2792670|NCT00573248|Primary|Side Effects|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days||||Percent of item endorsement||Standard Error|Mean
2792671|NCT00573248|Primary|Negative Moods|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days||||Percent of item endorsement||Standard Error|Mean
2792672|NCT00573248|Secondary|Blood Pressure|Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches|4 days||||mm HG||Standard Deviation|Mean
2792673|NCT00573248|Primary|ADHD Symptoms|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.|||Percent of item endorsement||Standard Error|Mean
2792674|NCT00573183|Secondary|Attendance at 12-step Meetings|Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period|6 months|The sample size was originally powered based on the primary outcome measure, not on the secondary 12-step measures.The analysis sample size was reduced due to missing values|||days of attending 12-step meetings||Standard Deviation|Mean
2792675|NCT00573183|Primary|Days of Stimulant Use|Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period|6 months|The original sample size was based on power analysis and took attrition into account. Of the 471 individuals randomized to treatment, 50 subjects (TAU, n=20, STAGE-12, n=30) did not have any post-baseline measures and were therefore eliminated from the statistical analysis of the primary outcome and some of the secondary outcomes.|||days of stimulant use||Standard Deviation|Mean
2792676|NCT00573170|Secondary|"Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire)"|"Clinical disability for each participant was assessed using the CDQ. This scale uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is normal/not impaired, 2 is mildly impaired, 3 is moderately impaired, 4 is severely impaired, and 5 is 'required bedrest."|At dosing and at 2, 4, 6 and 8 hours after dosing of each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
2792677|NCT00573170|Secondary|Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
2792687|NCT00573170|Secondary|Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing|The number of participants with no pain and relief of sinus/facial pain in those participants for whom sinus/facial pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported sinus/facial pain at dose time.|||participants|||Number
2792678|NCT00573170|Secondary|Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
2792679|NCT00573170|Secondary|Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
2792680|NCT00573170|Secondary|Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
2792681|NCT00573170|Secondary|Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.|||scores on a scale||Standard Error|Mean
2792682|NCT00573170|Secondary|Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|"Participant alertness was evaluated with the 7-point modified SS scale, where 1 is feeling active, vital, alert, wide awake, 2 is still functioning at high levels, but not peak; able to concentrate, 3 is awake, but relaxed; responsive but not fully alert, 4 is somewhat foggy, let down, 5 is foggy, losing interest in remaining awake, 6 is sleepy, woozy, fighting sleep, prefer to lie down, and 7 is no longer fighting sleep, sleep onset soon, having dream like thoughts."|Dose time, 2, 4, 6, 8, 24 and 48 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population. Only participants who responded to the SS scale at a particular time point were included in the analysis for that time point.|||units on a scale||Standard Deviation|Mean
2792683|NCT00573170|Secondary|Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Overall cognition was assessed with a composite score (range 0-9) called the Performance Index, as derived from the number of correct responses per minute on subtests of the Mental Efficiency Workload Test (MEWT) cognitive battery. For a particular participant, lower scores indicate a negative impact, or worsened, general cognition; higher scores indicate improved cognition.|At time of dosing, and at 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||scores on a scale||Standard Deviation|Mean
2792684|NCT00573170|Secondary|Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Complete symptom-free is defined as migraine-free, neck pain-free, and sinus pain-free without the use of any rescue medication prior to the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
2792685|NCT00573170|Secondary|Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain|Pain relief is defined as having no or mild pain and no use of rescue medication after dosing in those participants who had moderate or severe pain at dosing.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - only participants who reported moderate or severe baseline pain were included in this analysis.|||participants|||Number
2792686|NCT00573170|Secondary|Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline|The number of participants with no pain and relief of neck pain in those participants for whom neck pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported neck pain at dose time.|||participants|||Number
2795645|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients|||Participants|||Number
2792688|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose|The number of participants with no pain and relief of vomiting in those participants for whom vomiting was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported vomiting at dose time.|||participants|||Number
2792689|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported phonophobia at dose time.|||participants|||Number
2792690|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported photophobia at dose time.|||participants|||Number
2792691|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported nausea at dose time.|||participants|||Number
2792692|NCT00573170|Secondary|Number of Participants With a Migraine-free Response 2-48 Hours After Dosing|Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia [sensitivity to light], and phonophobia [sensitivity to sound]) with use of any rescue medication before the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
2792693|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing.|||hours||Standard Deviation|Mean
2792694|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing.|||hours||Standard Deviation|Mean
2792695|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing.|||hours||Standard Deviation|Mean
2792728|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT3 to Predict Lymph Node Status at Surgery|%change in SUVmax from FLT1‐FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1‐FLT3 will be consider the outcome.|Baseline (FLT-1) and post-NAC (FLT-3)|Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1‐3 LN metastases and 6 with >3 LN metastases|||percent change in SUVmax from FLT1‐FLT3||Standard Deviation|Mean
2792696|NCT00573170|Secondary|Number of Participants Using Rescue Medication Within 48 Hours Post Dose|Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
2792697|NCT00573170|Secondary|Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose|Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population|||participants|||Number
2792698|NCT00573170|Primary|Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose|SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.|From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Intent-to-Treat (ITT) Population: all participants who were treated with investigational product and provided at least one post-dose efficacy assessment . Participants may have been included in one, two, or all of the Placebo, Treximet and Butalbital-containing combination medication arms due to the cross-over nature of the study design.|||participants|||Number
2792699|NCT00573157|Secondary|Number of Participants With New Lupus Flares||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.||||||
2792700|NCT00573157|Secondary|Percentage of Participants With Normalization of Renal Function||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.||||||
2792701|NCT00573157|Primary|Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response|Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate [GFR]), improvement in proteinuria (urine protein/creatinine ratio <0.5) & resolution of hematuria. Partial response (PR): from baseline, a <= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) & resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.|At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.||||||
2792702|NCT00573144|Secondary|Myocardial Infarct Size at 30 Days|Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%.|30 days||||percentage of total cardiac tissue mass||Standard Deviation|Mean
2792703|NCT00573144|Secondary|Change in Left Ventricular End-Systolic Diastolic Volume Index|Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days||||mL blood/meter^2 body surface area||Standard Deviation|Mean
2792704|NCT00573144|Primary|Change in Left Ventricular End-Systolic Volume Index|Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days||||mL of blood/meter^2 body surface area||Standard Deviation|Mean
2792705|NCT00573131|Primary|Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT||Screening and Week 12|Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.|||percentage of patients|||Number
2792741|NCT00572624|Secondary|Mean Heart Rate|Heart rate was measured at scheduled physical examinations.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||beats per minute||Standard Deviation|Mean
2792874|NCT00571038|Secondary|Change in Number of Blood Pressure Medications|Change in mean # of prescription blood pressure medications|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||blood pressure medications||Standard Error|Mean
2792706|NCT00573066|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours)|Based on an estimated inter-subject variability of 50% for steady state concentration, a sample size of 36 evaluable subjects will be sufficient to detect a difference (alpha 0.05, power 0.8) for the area under the concentration-time curve (AUC) and steady state concentration (Css) between the three dosing groups.|||mL/min/(kg^0.75)||Standard Error|Least Squares Mean
2792707|NCT00572936|Primary|Uvescleral Outflow|uvescleral outflow was calulated using goldmann equation|2 weeks||||µL/min per mm Hg||Standard Deviation|Mean
2792708|NCT00572936|Primary|Outflow Facility|outflow facility was calculated using fluorophotometry and tonography|2 weeks||||µL/min per mm Hg||Standard Deviation|Mean
2792709|NCT00572936|Primary|Episcleral Venous Pressure|Episcleral venous pressure was measured by venomenometry|2 weeks||||mmHg||Standard Deviation|Mean
2792710|NCT00572936|Primary|Blood Pressure|blood pressure was measured by sphygmomanometry|2 weeks||||mmHg||Standard Deviation|Mean
2792711|NCT00572936|Primary|Anterior Chamber Volume|Anterior chamber volume was measured by A-scan ultrasound biometry, daytime|2 weeks||||μL||Standard Deviation|Mean
2792712|NCT00572936|Primary|Central Corneal Thickness|central corneal thickness was measured by ultrasound pachymetry|2 weeks||||μm||Standard Deviation|Mean
2792713|NCT00572936|Primary|Aqueous Flow|aqueous flow measurements was calculated using fluorophotometry measurements.|2 weeks||||μL/min||Standard Deviation|Mean
2792714|NCT00572936|Primary|Intraocular Pressure|Intra-ocular Pressure was measured by applanation tonometry|2 weeks||||mmHg||Standard Deviation|Mean
2792715|NCT00572910|Primary|Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)|"Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.~Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination."|Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.||||Participants|||Number
2792716|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints|Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.|Prevaccination to 360 days post vaccination||||Ratio||95% Confidence Interval|Geometric Mean
2792717|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination|Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.|Prevaccination to 56 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2792718|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 180 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2792719|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.|Prevaccination to 28 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2792720|NCT00572910|Primary|Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 56 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
2792721|NCT00572897|Secondary|Transplant-related Mortality|Transplant-related Mortality including Graft-versus-host disease (GVHD)|2 years||||participants|||Number
2792722|NCT00572897|Secondary|PLT|Patients with PLT ≥20 × 109/L|2 years||||participants|||Number
2792723|NCT00572897|Secondary|Absolute Neutrophil Count (ANC)|Patients with ANC ≥0.5 × 10^9/L|2 years||||participants|||Number
2792724|NCT00572897|Secondary|Overall Survival|The number of patients alive at last follow-up.|73 months||||participants|||Number
2792725|NCT00572897|Secondary|Response Outcomes|assessed according to the IWG Criteria|180 days|Clinical responses were assessed according to the IWG-MRT 2006 criteria in 46 patients (29 sibling and 17 unrelated transplants) who survived at least 180 days.|||participants|||Number
2792726|NCT00572897|Primary|The Primary Endpoint is Progression-free Survival.|Number of participants alive at 2 years who are progression-free|2 years||||participants|||Number
2792727|NCT00572832|Primary|Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule|Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.|1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)|The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive.|||milliMerck units per mL||95% Confidence Interval|Geometric Mean
2792729|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT2 to Predict Lymph Node Status at Surgery|Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.|Baseline (FLT-1) and Early Therapy (FLT-2)|Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1‐3 LN metastases and 9 with >3 LN metastases|||percent change in SUVmax from FLT1‐FLT2||Standard Deviation|Mean
2792730|NCT00572728|Secondary|Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor|"To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome.~Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section"|Baseline (FLT-1) and post-NAC (FLT-3)|43 patients who had both FLT1 and FLT3 scans|||percentage change in SUVmax||Standard Deviation|Mean
2792731|NCT00572728|Secondary|SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.|post-NAC (FLT-3)|After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
2792732|NCT00572728|Secondary|SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein.~Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III"|early treatment (FLT2)|after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
2792733|NCT00572728|Secondary|SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein.~Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III"|Baseline (FLT-1)|@ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
2792734|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT3 (Post-NAC)|For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells.|Post-NAC (FLT3)|43 patients who had suitable post‐NAC tissue samples for correlation between surgical specimens and FLT3 SUVs|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
2792735|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT1(Baseline PET)|"For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 .~Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells."|Baseline (FLT-1)|1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data|||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
2792736|NCT00572728|Primary|%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response|The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies|Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)|Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2)|||percentage change of SUVmax||Standard Deviation|Mean
2792737|NCT00572624|Secondary|Mean Homeostasis Model Assessment of Insulin Resistance|The homeostasis model assessment of insulin resistance (HOMA) was used to calculate insulin resistance using the first AM, fasting glucose and insulin levels. Plasma insulin levels were measured by radioimmunoassay, and glucose levels were measured by automated hexokinase assay. A HOMA score of <3 represents normal insulin resistance, a score between 3 and 5 moderate insulin resistance, and a score of 5 or higher represents severe insulin resistance.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||units on a scale||Standard Deviation|Mean
2792738|NCT00572624|Secondary|Mean Total Serum Cholesterol and Triglycerides|Blood testing was conducted at scheduled times during the study. Serum cholesterol and triglycerides were measured by the enzymatic method (Roche Diagnostics).|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||mg/dl||Standard Deviation|Mean
2792739|NCT00572624|Secondary|Mean Body Mass Index|Participant weight and height was measured at scheduled physical examinations. Body mass index was calculated as participant body weight in kilograms divided by their height in meters squared.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||kg/m^2||Standard Deviation|Mean
2792740|NCT00572624|Secondary|Mean Arterial Pressure|Mean arterial pressure was measured at scheduled physical examinations.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||mm Hg||Standard Deviation|Mean
2792742|NCT00572624|Secondary|Left Ventricular (LV) Mass|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic study were performed using second harmonic imaging. Left ventricular (LV) mass was measured using the area-length method. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||grams||Standard Deviation|Mean
2792743|NCT00572624|Secondary|Septal Ratio (E/E')|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic studies were performed using second harmonic imaging. The early diastolic (E) velocity was measured, left ventricular relaxation (E') was measured at the lateral mitral annulus, and the E/E'(septal) ratio was calculated. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms. The normal septal ratio from the lateral mitral annulus is <5, a ratio from 5 to 10 is indeterminate, and a ratio of >10 indicates elevated left atrial pressure.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||ratio||Standard Deviation|Mean
2792744|NCT00572624|Secondary|Left Ventricular (LV) Relaxation (E')|Immediately following MVO2 measurement, complete two-dimensional, M-mode, and Doppler echocardiographic studies were performed using second harmonic imaging. Left ventricular relaxation (E') was measured at the lateral annulus. All reported measurements represent the average of three consecutive cardiac cycles. A single investigator blinded to all clinical parameters evaluated all echocardiograms.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||cm/second||Standard Deviation|Mean
2792745|NCT00572624|Primary|Total Myocardial Fatty Acid (FA) Oxidation|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial fatty acid utilization was measured using positron emission tomography (PET) after injecting 1-^11C-palmitate. Total fatty acid oxidation was calculated by multiplying the fatty acid oxidation rate by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||nmol/g/min||Standard Deviation|Mean
2792746|NCT00572624|Primary|Total Myocardial Fatty Acid (FA) Utilization|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial blood flow was measured using positron emission tomography (PET) following injection of ^30O-water. Myocardial fatty acid (FA) utilization was measured using PET after injection of 1-^11C-palmitate. The calculations that describe the relationship between the different measures of myocardial FA metabolism are: FA utilization/gram = blood flow/gram × FA uptake/gram × [average plasma free FA at the time of the 1-11C-palmitate injection]; FA utilization/gram = FA oxidation/gram + esterification/gram. Total fatty acid utilization was calculated by multiplying the fatty acid utilization rate by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study and for whom data are available|||nmol/g/min||Standard Deviation|Mean
2792747|NCT00572624|Primary|Total Myocardial Oxygen Consumption (MVO2)|The evening before an imaging study, all participants were given a meal containing 12 kcal/kg adjusted body weight (=ideal body weight + ((actual body weight-ideal body weight) x 0.25)). Participants fasted until their imaging studies were completed. Myocardial oxygen consumption (MVO2) was measured using positron emission tomography (PET) following injection of 1-^11C-acetate. Total MVO2 was calculated by multiplying the MVO2 measure by left ventricular weight.|Measured at baseline, 16 months after gastric bypass surgery-induced weight loss, and 8 months after diet-induced weight loss|Participants who lost 5% of their body weight during the study|||µmol/min||Standard Deviation|Mean
2792748|NCT00572572|Secondary|Preferred Treatment Cycle|Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.|2 months|There were 49 subjects during the Aprepitant treatment and the Placebo treatment for each cycle that had complete data for the analysis of the preferred treatment cycle.|||percentage of subjects with a preference|||Number
2792749|NCT00572572|Secondary|MD Anderson Symptom Inventory Score|The MD Anderson Symptom Inventory (MDASI) is a brief measure of the severity and impact of cancer-related symptoms. Thirteen core items measure the severity of symptoms and six additional items measure the impact of symptoms. All items are rated on a scale from 0 (not present or did not interfere) to 10 (maximal severity or interference). The mean value of the total nineteen items ranges from 0 to 10.|Days 1-8|There were 64 subjects during the Aprepitant treatment and 62 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the M.D. Anderson Symptom Inventory. The mean MDASI scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.|||units on a scale||Standard Deviation|Mean
2792750|NCT00572572|Secondary|Visual Analouge (VAS) 100mm Scale Score|The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. The mean VAS scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.|Days 1-8|There were 54 subjects during the Aprepitant treatment and 61 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the visual analouge scale for nausea and vomiting.|||mm||Standard Deviation|Mean
2792751|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.|Participants were evaluated from cycle days 6-8.||||percentage of evaluable subjects|||Number
2792752|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 1-5.|Participants were evaluated from cycle days 1-5.||||percentage of evaluable subjects|||Number
2792763|NCT00572468|Primary|Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.|Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.|5 years|We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.|||Percentage of cells||95% Confidence Interval|Mean
2792764|NCT00572260|Primary|Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision||30 days after surgery|The study closed due to the departure of the principal investigator and the data analysis was not performed.||||||
2792765|NCT00572234|Primary|Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.|The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.|Assessed Methamphetamine use at weeks 12 and 24, week 24 reported|Analyses were per protocol and based on number of participants enrolled in study who were not withdrawn from the study.|||days||Standard Deviation|Mean
2792766|NCT00572195|Secondary|Adverse Event Rate|The rate of occurrence of any adverse event (AE) observed during the Long-term Treatment Investigation.|6 months post-implant through 9 years post-implant (8.5 years)|N represents the number of subjects who have data during that period.|||Participants|||Count of Participants
2792767|NCT00572195|Secondary|QOLIE (Quality of Life in Epilepsy)|QOLIE 89 (for English-speaking subjects) or QOLIE 31 P (for Spanish speaking subjects) scores collected at each year of follow-up after implantation of the RNS® System compared to the QOLIE 89 / QOLIE 31 P at pre-implant baseline. A QOLIE overall score was obtained using a weighted average of multi-item scale scores. The QOLIE overall score was converted to a T-score, a normally distributed scale with a mean score of 50 and standard deviation (SD) of 10. Higher scores reflect a better quality of life.|1 year post-implant through 9 years post-implant (8 years)|N represents the number of subjects who have data during that period.|||Score on a scale||Standard Deviation|Mean
2792768|NCT00572195|Secondary|Responder Rate|The proportion of subjects with greater than or equal to 50% reduction in total disabling seizures compared to pre-implant baseline.|6 months post-implant through 9 years post-implant (8.5 years)|N represents the number of subjects who have data during that period.|||Percentage of patients||95% Confidence Interval|Number
2792769|NCT00572195|Primary|Percentage Change From Baseline in Seizure Frequency|The average percentage change in the mean frequency of total disabling seizures relative to pre-implant baseline. The percent change will be calculated for each subject over 6-month intervals beginning 6 months after RNS® System implant and continuing through completion of the RNS® System LTT study.|6 months post-implant through 9 years post-implant (8.5 years)|N represents the number of subjects who have data during that period.|||Percentage of Change||Inter-Quartile Range|Median
2792770|NCT00572195|Primary|Number of Participants With Serious Adverse Events (SAE)|The number of subjects having an SAE during the RNS® System LTT study.|2 years post-implant through 9 years post-implant (7 years)||||Participants|||Count of Participants
2792771|NCT00572156|Secondary|Summary of Adverse Events With Number of Occurrences|A Data Monitoring Committee (DMC) was established to monitor subject safety|Approximately up to 4 years.|Safety population: Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.|||Number of events|||Number
2792772|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||pmol/L||Standard Deviation|Mean
2792773|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||mg/L||Standard Deviation|Mean
2792774|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
2792775|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
2792776|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
2792777|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||ng/mL||Standard Deviation|Mean
2792778|NCT00572156|Secondary|Skeletal Maturation|"Assessed by bone age. Bone age was determined by the radiograph.~The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline(day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).|||SDS||Standard Deviation|Mean
2792804|NCT00571701|Secondary|Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.|Percent of patients of each gender with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline|Baseline to12 months|All patients who completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent responders|||Number
2792779|NCT00572156|Secondary|Total Change From Baseline (Day 1) in BMI SDS|"BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).~The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).|||SDS||Standard Deviation|Mean
2792780|NCT00572156|Secondary|Predicted Adult Height (PAH)|"Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.~The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline (Day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).|||SDS||Standard Deviation|Mean
2792781|NCT00572156|Secondary|Cumulative Change in Height Standard Deviation Score (SDS)|"Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.~The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|First, second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||SDS||Standard Deviation|Mean
2792782|NCT00572156|Secondary|Height Velocity||Second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.|||cm/y||Standard Deviation|Mean
2792783|NCT00572156|Primary|Height Velocity||First year of treatment|"Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.~[n= 25,27,27,26]"|||cm/y||Standard Deviation|Mean
2792784|NCT00572117|Secondary|Effect of Treatment on Mood Symptoms|The 17-item Hamilton Depression Rating Scale (HAM-D) is a standard measure of symptoms of depression with a scoring range of 0-53 points. Higher HAM-D scores represent more depression, so a lowering of HAM-D scores is considered a good outcome, an increase in HAM-D scores considered a worsening of outcomes.|Baseline and 12 weeks||||units on a scale||95% Confidence Interval|Mean
2792785|NCT00572117|Primary|Amount of Alcohol Consumed|Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.|Baseline and 12 weeks||||number of drinks per heavy drinking day||95% Confidence Interval|Mean
2792786|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|6 months|105 PST and 110 ST participants provided data at 6 months.|||units on a scale||Standard Deviation|Mean
2792787|NCT00572039|Primary|Targeted Vision Function|"We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its difficulty (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated."|6 months|105 PST and 110 ST participants provided data at 6 months.|||units on a scale||Standard Deviation|Mean
2792788|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|3-Months|106 PST and 112 ST participants provided data at 3 months.|||units on a scale||Standard Deviation|Mean
2792805|NCT00571701|Secondary|Percent of Patients With Positive Response to Treatment|Percent of patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline|Baseline to 12 months|All patients that completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent responders|||Number
2792875|NCT00571038|Secondary|Non-Clinic Blood Pressure Checks|% reporting non-clinic blood pressure (BP) checks at least once a month|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||percentage of participants|||Number
2792789|NCT00572039|Primary|Targeted Vision Function (TVF)|"We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its difficulty (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated."|3-Months|106 PST and 112 ST participants provided data at 3 months.|||units on a scale||Standard Error|Mean
2792790|NCT00571987|Secondary|Recurrence of Breast Cancer at Prior Site of Disease||Until study end (2 years)|During the 68-month median follow-up in patients not treated with XRT, there were 2 in-site tumor recurrences treated with AI, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy.|||participants|||Number
2792791|NCT00571987|Primary|Number of Patients Requiring 2nd Surgery for Close or Positive Margins|"A close surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a wide surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined close as less than 3 mm."|Margins assessed at Final Pathology, approximately 1 week post-RF surgery||||participants|||Number
2792792|NCT00571974|Primary|The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).|The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.|Day 90|The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall.|||participants|||Number
2792793|NCT00571974|Primary|Maximum Tolerated Dose|The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.|Day 2|Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures (laser doses) of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. The highest radiant light dose attained that did not produce more than 2 DLTs was declared to be the maximum tolerated dose (MTD).|||J/cm2|||Number
2792794|NCT00571961|Primary|Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)|Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.|15 days||||(ng/mL)*hr||Standard Deviation|Mean
2792795|NCT00571948|Primary|Parameters of Iron Status in Blood||at the end of the fourth, seventh, tenth month of life|||||||
2792796|NCT00571948|Secondary|Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences||dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month|||||||
2792797|NCT00571948|Primary|Sum of Omega-3 Fatty Acid Pattern in Plasma|"fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids.~Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th)."|at the end of the tenth month of life||||percent of total fatty acids||Inter-Quartile Range|Median
2792798|NCT00571922|Secondary|Craving||7 day|PI passed away, data is unavailable||||||
2792799|NCT00571922|Primary|Methamphetamine Abstinence||7 day|PI passed away, data is unavailable.||||||
2792800|NCT00571701|Secondary|Maintenance of Response Following Discontinuation of Celecoxib|Percent of patients who responded to celecoxib with increase in papilloma growth rate of no greater than 0.01 at end of second treatment period compared to growth rate at end of first treatment period.|End of first treatment period (month 12) to end of second treatment period (month 24)|All patients with complete response to celecoxib in first treatment period who completed the second treatment period where they received placebo. Because the number of responders was so small, no statistical analysis was performed.|||percent of patients|||Number
2792801|NCT00571701|Secondary|Correlation Between Mean Plasma Level of Celecoxib and Response.|Mean plasma levels of celecoxib over months 3-12 in first treatment period correlated with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|All patients who were randomized to receive celecoxib first and completed the first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||pg. celecoxib/ml. plasma||Full Range|Mean
2792802|NCT00571701|Secondary|Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%|Percent of patients with HPV 6 versus patients with HPV 11 with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|Analysis conducted on all patients with HPV 6 or 11 infection who completed first treatment period. One patient with both HPV 6 and 11 and one patient with neither 6 or 11 were excluded. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent of responders|||Number
2792803|NCT00571701|Secondary|Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.|Percent of juvenile versus adult onset patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.|Baseline to 12 months|Analysis conducted on all patients who completed first treatment period. Juvenile onset is defined as <18 years of age at time of diagnosis. Age of disease onset for 2 patients was not available. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percentage of responders|||Number
2792806|NCT00571701|Primary|Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline|Change in mean growth rates during the last 3 months of the first treatment period compared to the mean values at baseline. Endoscopy and removal of all tumor was done every 3 months. Growth rate is calculated as the scored amount of papilloma recurrence in a 3 month period divided by the exact number of days since last endoscopy and removal of all tumor.|Baseline to 12 months|All patients in each arm who completed the first 1 year treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.|||percent change in mean growth rate||Standard Deviation|Mean
2792807|NCT00571688|Primary|Number of Relapse-related Events Normalized to Unit Time|The outcome was total number of events divided by number of months (normalized to unit time). This was be calculated by dividing the number of relapse related events by the number of months of participation. Relapse related events included: (1) YMRS score > 14 or MADRS > 15; (2) 20% or greater increase in the YMRS or MADRS scores from the previous study visit; (3) urgent care visit (psychiatric hospitalization; emergency department visit; referral for respite care, partial hospitalization, or intensive outpatient treatment) due to worsening mood symptoms; (4) a Clinical Global Impression Severity of Illness score >3; (5) syndromal relapse (Diagnostic and Statistical Manual of Mental Disorders, 4th Editionfor manic, hypomanic, major depressive, or mixed episode met); (6) withdrawal from the study due to inefficacy; and (7) necessary clinical medication adjustments (NCAs).|12 months|All randomized participants were analyzed.|||Events/month||Standard Deviation|Mean
2792808|NCT00571662|Secondary|Kinetics of Immunologic Reconstitution After Allogeneic Transplantation||at day 100 post transplantation||||percentage of cells in peripheral blood||Full Range|Median
2792809|NCT00571662|Secondary|Responses to Therapy|event-free and overall survival at 12 months|every 6 mo. up to 2 years||||Percent of Participants|||Number
2792810|NCT00571662|Secondary|Incidence of Acute and Chronic Graft-versus-host Disease|Incidence of acute and chronic graft-versus-host disease. Acute GVHD usually occurs during the first three months following transplant. Chronic GVHD usually develops after the third month post-transplant.|twice weekly until day 100 up to 1 year post transplant||||Percent of Particpants|||Number
2792811|NCT00571662|Primary|Toxicity for the Combination of Pentostatin and Low Dose Total Body Irradiation (TBI)||Conditioning regimen to count recovery (D + 28 post transplant)||||Participants|||Count of Participants
2792812|NCT00571662|Primary|Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting|the efficacy of the regimen as determined by engraftment rate and establishment of donor hematopoietic chimerism at day +28 and day +70.|days +28 and +70||||percent of participants||Full Range|Median
2792813|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.|Up to Day 10 + 5 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
2792814|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding|Up to Day 35 + 6 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
2792815|NCT00571649|Secondary|Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days|All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.|Up to Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
2792816|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations|||Percentage of participants|||Number
2792817|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35|||Percentage of participants|||Number
2792818|NCT00571649|Secondary|Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90|Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
2792819|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events|Up to Day 10 + 5 days|Participants valid for safety analysis, with adequate assessment of VTE (to Day 10 within 48 hours of study drug), met inclusion criteria, and no major protocol deviations; expanded to include participants who had major bleeding or clinically relevant non-major bleeding events and met all criteria for PP except valid assessment of thromboembolism.|||Percentage of participants|||Number
2792820|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants with major and clinically relevant bleeding events.|||Percentage of participants|||Number
2792821|NCT00571649|Secondary|Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90|Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.|||Percentage of participants|||Number
2792822|NCT00571649|Secondary|Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10) expanded to include participants who had an assessment of all deaths, including not VTE-related|||Percentage of participants|||Number
2792823|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10|||Percentage of participants|||Number
2792824|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants who had an assessment of all deaths, including not VTE-related|||Percentage of participants|||Number
2792825|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol (PP) Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations.|||Percentage of participants|||Number
2792826|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35|||Percentage of participants|||Number
2792827|NCT00571493|Secondary|Progression-free Survival (PFS), and Overall Survival (OS)|To obtain a preliminary estimate of PFS and OS. Overall survival (OS) is defined as time from the first chemotherapy administered on the transplant trial until death from any cause. Progression free survival (PFS)is defined as time from therapy until relapse, progression, or death from any cause.|one year post autologous hematopoietic stem cell transplantation (ASCT) , 5 years post ASCT|There were 38 evaluable patients at one year post autologous hematopoietic stem cell transplantation (ASCT).|||percentage of participants||95% Confidence Interval|Number
2792828|NCT00571493|Secondary|Preliminary Estimate of Overall Response Rate (ORR)|To obtain a preliminary estimate of overall response rate (ORR). The overall response rate is calculated as the number of patients who achieved complete response (CR) and partial response (PR) divided by the total number of evaluable patients.|100 day post autologous hematopoietic stem cell transplantation (ASCT), one year post ASCT|"One hundred days after autologous hematopoietic stem cell transplantation (ASCT), 40 participants were evaluable for response.~At year one post ASCT, 38 participants were evaluable for response. Participants evaluable for the secondary endpoints (Phase II) are those who complete the transplant procedure."|||participants|||Number
2792829|NCT00571493|Primary|Maximum Tolerated Dose (MTD) of Bortezomib|The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort.|14 months|The MTD in Phase I was initially determined to be 1.5 mg/m2 but was later decreased to 1 mg/m2.|||mg/m²|||Number
2792830|NCT00571428|Secondary|Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point.|immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population|||liters||Standard Deviation|Mean
2792831|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration.|pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population|||minutes||Standard Deviation|Mean
2792835|NCT00571428|Secondary|Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing.|12 hours|Intent to treat population|||percent of predicted FEV1||Standard Deviation|Mean
2792836|NCT00571428|Secondary|Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||percent of predicted FEV1||Standard Deviation|Mean
2792837|NCT00571428|Secondary|Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points.|Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||Percent of Predicted FEV1||Standard Deviation|Mean
2792838|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||liters||Standard Deviation|Mean
2792839|NCT00571428|Secondary|Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose.|pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose|Intent to treat population|||liters||Standard Deviation|Mean
2792840|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level.|pre-dose and 24 hours post-dose|Intent to treat population|||liters||Standard Deviation|Mean
2792841|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing.|12-24 hours|Intent to treat population|||liters||Standard Deviation|Mean
2792842|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing.|0-12 hours|Intent to treat population|||liters||Standard Deviation|Mean
2792843|NCT00571428|Primary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.|0-24 hours post dose|Intent to treat population|||liters||Standard Deviation|Mean
2792844|NCT00571324|Secondary|Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma intact glucagon-like Peptide-1 (GLP-1) levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean intact GLP-1 area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||pmol*min/L||Standard Error|Mean
2792845|NCT00571324|Secondary|Mean Plasma Glucagon Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma glucagon area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||pg*min/dL||Standard Error|Mean
2792846|NCT00571324|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||pmol*min/L||Standard Error|Mean
2792876|NCT00571038|Secondary|Change in Time Since Last Physician Visit|Change in mean # of months since last visit to a physician|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||months (since last visit)||Standard Error|Mean
2792847|NCT00571324|Primary|Mean Blood Glucose Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on fasting blood glucose levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean blood glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.|||mmol*min/L||Standard Error|Mean
2792848|NCT00571194|Primary|Pharmacokinetics||24 hours|Data was not collected||||||
2792849|NCT00571103|Primary|The Primary Efficacy Measure Was the Yale-Brown Obsessive Compulsive Scale Modified for PG (YBOCS-PG).|The YBOCS-PG (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) is used to assess the range and severity of PG symptoms. The scale is a modification of the YBOCS originally developed by Goodman et al. (1989) for use in rating severity and change in subjects with Obsessive Compulsive Disorder. This adaptation is a 10-item clinician-rated questionnaire, which rates (on a 5-point scale from 0 to 4) time spent, distress, interference, resistance, and control in relation to PG urges and behaviors. The scale ranges from 0 to 40 with a higher score representing increased severity in PG.|8 weeks minus baseline||||units on a scale||Standard Error|Mean
2792850|NCT00571103|Secondary|The Secondary Efficacy Evaluations Will Include the G-SAS (Gambling Symptom Assessment Scale), Clinical Global Impression - Improvement Scale (CGI-I) , and the CGI-S Clinical Global Impression - Severity Scale.|The G-SAS is a 12 item self-report instrument that reflects the subjects urges to gamble and the subjects gambling behavior. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms) with a total score range from 0 to 48. The CGI-I is a 7 point scale requiring the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill patients.|8 weeks minus baseline|A total of 39 participants were screened by phone and 5 failed to meet screening criteria and were excluded; 6 did not return for the baseline visit because of follow-up loss or choosing to discontinue participation. of the remaining 28 patients, 1 discontinued and another was lost to follow-up after the baseline visit. That left 26 subjects.|||units on a scale||Standard Error|Mean
2792851|NCT00571064|Secondary|Change From Baseline in DAD Total Score by Visit|"The DAD was a 10 domain 40-item scale that measured a participant's ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were No, Yes, and N/A. A No answer scored 0 and a Yes answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach."|Baselinw, Week 6 (Visit 3) and Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792852|NCT00571064|Secondary|Disability Assessment in Dementia (DAD) Total Score by Visit|"The DAD was a 10 domain 40-item scale that measured a participant's ability to initiate, plan, organize, and perform both basic and instrumental activities of daily living. These domains were: hygiene (7 items), dressing (5 items), continence (2 items), eating (3 items), meal preparation (3 items), telephoning (4 items), going on an outing (5 items), finance (4 items), medication (2 items), and leisure (5 items). The three responses to the DAD items were No, Yes, and N/A. A No answer scored 0 and a Yes answer scored 1. The scoring range was 0-40, with a higher score indicating less disability (better quality of life). If N/A was selected then it was treated as missing. When there were items with missing values, the domain sub-scores and the total score were imputed. Domain sub-scores were summed to yield a total raw score. This was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score can be calculated in the similar approach."|Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792853|NCT00571064|Secondary|Change From Baseline in ADRQL Total Score by Visit|The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person's special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person's living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Higher scores reflected a better quality of life. Change from Baseline in ADRQL Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792854|NCT00571064|Secondary|Alzheimer Disease-related Quality of Life (ADRQL) Total Score by Visit|The ADRQL was an observer-rated quality of life instrument that measured the following domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. The ADRQL was a 47-item questionnaire with five domains: relating to and being around other people (ADRQL-A; 12 items), a person's special identity and important relationships (ADRQL-B; 8 items), different types of behavior (ADRQL-C; 15 items), usual activities (ADRQL-D; 5 items), and behavior in a person's living environment (ADRQL-E; 7 items). Domain sub-scores were summed to yield a total raw score, which was divided by the total possible score and multiplied by 100 to produce the final score. Each subscale score could be calculated in the similar approach. Total score ranges from 0-100 where higher scores reflected a better quality of life.|Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792855|NCT00571064|Secondary|Change From Baseline in NPI-8 Total Score by Visit|The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances. Change from Baseline in NPI-8 Total Score at Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792856|NCT00571064|Secondary|Neuropsychiatric Inventory (NPI-8) Total Score by Visit|The NPI-8 was an 8-item scale that assessed eight behavioral domains: delusions, hallucinations, agitation, depression, anxiety, apathy, irritability, and aberrant motor behavior. The frequency (0 to 4) and severity (0 to 3) of each domain were assessed; the sub-score for each domain was calculated as the product of the frequency and severity rating. The total score for the NPI was calculated as the sum of the domain sub-score, range from 0 to 96, with higher scores indicating greater behavior disturbances.|Baseline (Visit 2), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792857|NCT00571064|Primary|Change From Baseline in MMSE Total Score by Visit|The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluated orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the ITT population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the LOCF from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF. Change from Baseline in MMSE Total Score at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Scores on a scale||Standard Deviation|Mean
2792858|NCT00571064|Secondary|Change From Baseline in CAS Total Time by Visit|The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer's participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times. Change from Baseline in CAS Total Time at Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint) has been reported.|Baseline, Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at Week 12 included ITT population with LOCF.|||Hours/day||Standard Deviation|Mean
2792859|NCT00571064|Secondary|Caregiver Activity Survey (CAS) Total Time by Visit|The CAS was a validated tool that measured the time caregivers spent aiding Alzheimer's participants with their day-to-day activities. The CAS recorded time spent on six activities of daily living, communicating with the person, using transportation, dressing, eating, looking after one's appearance, and supervising the person. Caregivers were asked to report the amount of time spent on each activity during a 'typical' caregiving day. Total time for the CAS was calculated as the sum of the sub-item times.|Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or ET Visit, Week 12 LOCF (Study Endpoint)|ITT population included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable. Study endpoint evaluation at week 12 included ITT population with LOCF.|||Hours/day||Standard Deviation|Mean
2792877|NCT00571038|Secondary|Change in Health Status|"Response to the question How would you rate your general health status?. Response options are scored as follows.~Excellent~Very Good~Good~Fair~Poor We report the change in health status from baseline to 12 months."|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||units on a scale (range 1-5)||Standard Error|Mean
2792878|NCT00571038|Secondary|Change in BMI|Mean/SE change in Body Mass Index (BMI) (kg/m2)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||kg/m2||Standard Error|Mean
2792860|NCT00571064|Primary|Mini Mental State Examination (MMSE) Total Scores by Visit|The MMSE was a brief test that assessed the cognitive status of the participant. The 30-point test included items that evaluate orientation to time and place, immediate and delayed recall, attention, language, and construction. The total number of correct responses was obtained. The scores ranged from 0 to 30, with higher scores representing better performance. Summaries and analyses in the Intent-to-Treat (ITT) population were carried out using observed cases at each visit. A Study Endpoint evaluation was performed using the last observation carried forward (LOCF) from the open label treatment phase for each participant. The outcome of the study was based on analyses of the primary efficacy variable at Study Endpoint, which was defined as end of study assessment, using the ITT population with LOCF.|Baseline (Visit 2), Week 6 (Visit 3), Week 12 (Visit 4) or Early Termination (ET) Visit, Week 12 LOCF (Study Endpoint)|ITT population with LOCF included all enrolled participants who took at least one dose of study medication, and had baseline and at least one post-baseline assessment of at least one efficacy variable.|||Scores on a scale||Standard Deviation|Mean
2792861|NCT00571038|Secondary|Change in Patient Activation|"Mean/SE change in score on:~Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792862|NCT00571038|Secondary|Change in Health Opinions|"Mean/SE change in overall score on:~Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792863|NCT00571038|Secondary|Change in Social Support|"Mean/SE change in overall score on:~Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792864|NCT00571038|Secondary|Change in Self Efficacy|"Mean/SE change in score on:~Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792865|NCT00571038|Secondary|Change in Medication Adherence|"Mean/SE change in score on:~Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792866|NCT00571038|Secondary|Change in Fruit and Vegetable Intake|Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||servings of fruits & vegetables per day||Standard Error|Mean
2792867|NCT00571038|Secondary|Change in Daily Steps|Mean/SE change in # of steps per day (self report)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||steps per day||Standard Error|Mean
2792868|NCT00571038|Secondary|Change in Physical Activity Level|"Mean/SE change in score on:~Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||METS||Standard Error|Mean
2792869|NCT00571038|Secondary|Change in Sodium Intake|"Mean/SE change in score on:~Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792870|NCT00571038|Secondary|Change in Alcohol Use|"Mean/SE change in score on:~Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792871|NCT00571038|Secondary|Change in Satisfaction With Blood Pressure Treatment|"Mean/SE change in score on:~Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792872|NCT00571038|Secondary|Change in Hypertension Attitudes|"Mean/SE change in score on:~Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792873|NCT00571038|Secondary|Change in Hypertension Knowledge|"Mean/SE change in score on:~Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.|||survey score||Standard Error|Mean
2792883|NCT00570921|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as a complete response, partial response, or stable disease (CR, PR, SD) by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks or more.|Duration of response or stable disease for 24 weeks or more||||participants|||Number
2792884|NCT00570921|Secondary|Objective Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Evaluated 60 days after therapy start||||participants|||Number
2792885|NCT00570921|Primary|Time to Progression||Duration of time start of treatment to time of documented progression or death||||months||95% Confidence Interval|Median
2792886|NCT00570908|Primary|Progression Free Survival|Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.|2 years|5 patients progressed during the study treatment. 7 patients were off study treatment early due to AE or withdrawal but 6 of them were followed for the survival outcome, 1 was lost to follow up after 3.5 months observation (censored data).|||months||95% Confidence Interval|Median
2792887|NCT00570778|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events|Additional information about adverse events can be found in the Adverse Event Section.|47 days|Safety population includes all participants who received at least 1 dose of study drug.|||Participants|||Number
2792888|NCT00570778|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.|Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2792889|NCT00570778|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.|Baseline, Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.|||Liters||Standard Error|Least Squares Mean
2792890|NCT00570765|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 weeks|||||||
2792891|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: ALT|Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.|Baeline and 12 weeks||||Percent change||Standard Error|Mean
2792892|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: GGT|Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.|Baeline and 12 weeks||||Percent change||Standard Error|Mean
2792893|NCT00570765|Primary|Alkaline Phosphatase (AP) Levels|Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.|Baseline and 12 weeks|Per Statistical Analysis Plan (SAP): patients will be analyzed by the treatment group to which they were randomly assigned - intention to treat (ITT) principle.|||Percent change||Standard Error|Mean
2792894|NCT00570739|Secondary|Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792895|NCT00570739|Secondary|Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792896|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792897|NCT00570739|Secondary|Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792925|NCT00570739|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables.|||Percentage of change||Standard Error|Least Squares Mean
2792898|NCT00570739|Secondary|Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF|||Percent of participants|||Number
2792899|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792900|NCT00570739|Secondary|Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL*hr||Standard Error|Least Squares Mean
2792901|NCT00570739|Secondary|Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Change in Ratio||Standard Error|Least Squares Mean
2792902|NCT00570739|Secondary|Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||lb||Standard Error|Least Squares Mean
2792903|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792904|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792905|NCT00570739|Secondary|Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||ng/mL||Standard Error|Least Squares Mean
2792906|NCT00570739|Secondary|Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||uIU/mL||Standard Error|Least Squares Mean
2792907|NCT00570739|Secondary|Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792908|NCT00570739|Secondary|Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792909|NCT00570739|Secondary|Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792910|NCT00570739|Secondary|Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks||||ng/mL||Standard Error|Least Squares Mean
2792911|NCT00570739|Secondary|Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792912|NCT00570739|Secondary|Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792913|NCT00570739|Secondary|Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792914|NCT00570739|Secondary|Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792915|NCT00570739|Secondary|Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||nm||Standard Error|Least Squares Mean
2792916|NCT00570739|Secondary|Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. These 16 week analyses are both LOCF and no LOCF.|||nmol/L||Standard Error|Least Squares Mean
2792917|NCT00570739|Secondary|Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Inter-Quartile Range|Median
2792918|NCT00570739|Secondary|Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Inter-Quartile Range|Median
2792919|NCT00570739|Secondary|Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792920|NCT00570739|Secondary|Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792921|NCT00570739|Secondary|Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792922|NCT00570739|Secondary|Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792923|NCT00570739|Secondary|Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792924|NCT00570739|Secondary|Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2794134|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2792926|NCT00570739|Secondary|Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792927|NCT00570739|Secondary|Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16||Baseline to Week 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792928|NCT00570739|Secondary|Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change|||Number
2792929|NCT00570739|Secondary|Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT||Baseline vs. 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL*hr||Standard Error|Least Squares Mean
2792930|NCT00570739|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Last Observation Carried Forward was used for 16 week analyses.|||Percentage of change in LDL-C||Standard Error|Least Squares Mean
2792931|NCT00570739|Secondary|Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Ratio||Standard Error|Least Squares Mean
2792932|NCT00570739|Secondary|Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||lb||Standard Error|Least Squares Mean
2792933|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792934|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792935|NCT00570739|Secondary|Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of particpants|||Number
2792936|NCT00570739|Secondary|Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percent of participants|||Number
2792937|NCT00570739|Primary|Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.||Baseline to 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was used.|||Percentage of change of hemoglobin A1C||Standard Error|Least Squares Mean
2792963|NCT00570700|Secondary|Number of Subjects With Dasatinib Toxicity Using Common Terminology Criteria (CTC) (v. 3.0)|Due to relatively poor drug tolerance and relatively rapid PSA increases in most patients it was not feasible to continue patients on treatment until there was radiographic evidence of disease progression.|From initial date of treatment through study completion, up to 2 years||||Participants|||Count of Participants
2792938|NCT00570739|Secondary|Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792939|NCT00570739|Secondary|Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792940|NCT00570739|Secondary|Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792941|NCT00570739|Secondary|Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||nm||Standard Error|Least Squares Mean
2792942|NCT00570739|Secondary|Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||nmol/L||Standard Error|Least Squares Mean
2792943|NCT00570739|Secondary|Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change in Apo C3||Standard Error|Least Squares Mean
2792944|NCT00570739|Secondary|Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change in Apo B||Standard Error|Least Squares Mean
2792945|NCT00570739|Secondary|Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change in Apo A-1||Standard Error|Least Squares Mean
2792946|NCT00570739|Secondary|Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change of TG||Inter-Quartile Range|Median
2792947|NCT00570739|Secondary|Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change of TC||Standard Error|Least Squares Mean
2792948|NCT00570739|Secondary|Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||Percentage of change||Standard Error|Least Squares Mean
2792949|NCT00570739|Secondary|Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||percentage of change in non-HDL||Standard Error|Least Squares Mean
2793078|NCT00569803|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.|Days 1 and 116|All treated participants|||participants|||Number
2792950|NCT00570739|Secondary|The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||percentage of change in LDL-C||Standard Error|Least Squares Mean
2792951|NCT00570739|Secondary|2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||ng/mL||Standard Error|Least Squares Mean
2792952|NCT00570739|Secondary|2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||uIU/mL||Standard Error|Least Squares Mean
2792953|NCT00570739|Secondary|2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792954|NCT00570739|Secondary|1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792955|NCT00570739|Secondary|30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792956|NCT00570739|Secondary|Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.|||ng/mL||Standard Error|Least Squares Mean
2792957|NCT00570739|Secondary|Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||uIU/mL||Standard Error|Least Squares Mean
2792958|NCT00570739|Secondary|Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.|||mg/dL||Standard Error|Least Squares Mean
2792959|NCT00570739|Secondary|Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.||Baseline to 4, 8, 12, and 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was not used.|||Percentage of change in HbA1c||Standard Error|Least Squares Mean
2792960|NCT00570713|Secondary|Best Overall Response Rate|Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.|Baseline to response up to 21 months||||percentage of participants|||Number
2792961|NCT00570713|Secondary|Progression-free Survival|Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.|1-21 Months||||Months||95% Confidence Interval|Median
2792962|NCT00570713|Primary|Overall Survival (OS)|This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.|1-21 Months||||Months||95% Confidence Interval|Median
2792964|NCT00570700|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression, defined as the interval from the first day of dasatinib treatment until either (1) there has been a 50% increase in PSA above the treatment nadir, with a minimum of 5ng/mL, or (2) a 25% increase in PSA level above pretreatment levels, with a minimum of 5ng/mL. All PSA-based assessments require a confirmatory level no more than 1 month later.|From initial date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|Data not collected due to relatively poor drug tolerance and relatively rapid PSA increases in most patients as it was not feasible to continue patients on treatment.||||||
2792965|NCT00570700|Primary|Number of Subjects With Disease Control (DC) (Based on PSA, Bone Scan, FACT-P, RECIST)|"A positive effect will be defined as a complete response, partial response, or stable disease. Lack of positive effect will be defined as progressive disease. Subjects with a mixed response should be continued on therapy until they either fulfill the criteria for positive effect or lack of positive effect, with evaluation every 56 days.~The disease control (DC) rate was evaluated as a composite endpoint of the treatment effect on four parameters: 1) Prostate-specific antigen (PSA), 2) measurable disease (if present) by RECIST criteria, 3) bone scan, and 4) quality-of-life as measured by the FACT-P questionnaire."|From day 56 (8 weeks) and every 8 weeks thereafter until the date of first documented progression or date of death from any cause, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years|27 subjects were evaluable for response.|||Participants|||Count of Participants
2792966|NCT00570687|Primary|EGP AOC0-480 - Meal Challenge|EGP area over the curve from 0 to 480 minutes postdose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes. All subjects crossed over to lispro treatment. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; AOC could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.|||µmol/kg||Standard Deviation|Mean
2792967|NCT00570687|Primary|Minimum EGP - Meal Challenge|Minimum calculated EGP per subject as change from baseline|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.|||µmol/kg/min||Standard Deviation|Mean
2792968|NCT00570687|Primary|Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge|Time to minimum EGP post dose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.|||Minutes||Full Range|Median
2792969|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 24 Months|"The FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D'Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|Baseline and 24 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 24 months.|||units on a scale||Full Range|Median
2792970|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 12 Months|"The FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D'Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|Baseline and 12 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 12 months.|||units on a scale||Full Range|Median
2792971|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 6 Months|"he FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D'Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|Baseline and 6 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 6 months.|||units on a scale||Full Range|Median
2792983|NCT00570505|Post-Hoc|Change in Obesity Related Comorbid Conditions (5 Years)|Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL < 100 mg/dL, triglycerides < 150 mg/dL, and total cholesterol < 200 mg/dL. Hypertension resolution was defined as systolic blood pressure < 140 mm Hg.|5 years|Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)|||percentage of subjects|||Number
2792984|NCT00570505|Post-Hoc|Subject Percent Excess Weight Loss (5 Years)|The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)*100.|5 years|Intent-to-treat (ITT)|||percentage of excess weight loss||Standard Deviation|Mean
2792972|NCT00570674|Secondary|Change in FACT-H&N Score From Baseline to 4 Months|"The FACT-H&N is a multidimensional, self-report QoL instrument specifically designed for use with head and neck cancer patients. It is comprised of 27 core items from the FACT-G (Version 4), an established survey which assesses the impact of cancer therapy in four domains: physical, social/family, emotional, and functional.~[Cella, D, et al. JCO 1993(11)]. It is supplemented with a validated measure of 12 site specific items to assess for head and neck related symptoms. [D'Antonio L, Zimmerman G, et al. Cancer 1996 (77)] Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score (range: 0-156). Higher scores represent better QoL. The change score is calculated as post-baseline less baseline; therefore, a negative value indicates a decrease in score and correspondingly a decrease in QoL."|baseline and 4 months|The analysis dataset is comprised of patients with evaluable data at the 2 assessment timepoints: baseline and 4 months.|||units on a scale||Full Range|Median
2792973|NCT00570674|Secondary|Duration PEG Therapy|Estimated as the time from registration to the date of PEG removal.|Assessed until time of PEG removal which was up to 18.4 months in this study cohort.|The analysis dataset is comprised of all patients with date of PEG removal (evaluable). Reporting within dose cohorts is not preferred given the small sample sizes.|||months||Full Range|Mean
2792974|NCT00570674|Secondary|2-Year Overall Survival [Phase I]|2-year overall survival is the proportion of patients alive at 2-years from study entry.|All patients were followed for survival for a minimum of 2 years. Median survival follow-up was 44.7 months (range 10-70) in this study cohort.|The analysis dataset is comprised of all treated phase I patients. Reporting within dose cohorts is not preferred given the small sample sizes.|||proportion of participants||95% Confidence Interval|Number
2792975|NCT00570674|Secondary|Overall Response Rate [Phase I]|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|The primary re-staging assessment for response occurred 8-10 weeks following completion of treatment. Treatment duration was a mean (range) of 7.8 weeks (6.6-10.1).|The analysis dataset is comprised of all treated phase I patients. Reporting within dose cohorts is not preferred given the small sample sizes.|||proportion of participants||95% Confidence Interval|Number
2792976|NCT00570674|Primary|2-Year Disease-Free Survival [Phase II]|Disease-free survival (DFS) is defined as the time from registration to the earlier of disease recurrence or death from any cause. Patients alive without a recurrence are censored at the date of last disease evaluation. 2-year disease-free survival is the probability of patients remaining alive and progression-free at 2-years from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target.|Disease assessments occurred 8-10 weeks following treatment end then every 4-6 weeks (yr 1), every 8-10 weeks (yr 2), quarterly (yr 3) and semiannually up to 2 yrs since last pt enrolled.|The phase II portion planned to enroll 34 participants including the phase I expansion cohort but the study did not continue beyond phase I.||||||
2792977|NCT00570674|Primary|Dose Limiting Toxicity (DLT) [Phase I]|Dose limiting toxicities (DLT) were defined as treatment-related: 1) grade 3-4 non-hematological toxicity excluding untreated nausea, vomiting and diarrhea; dysphagia, esophagitis, mucositis/stomatitis, dermatitis/rash, 2) Grade 3 or greater febrile neutropenia occurring during chemoradiotherapy, 3) Grade 4 neutropenia lasting >/= 7 days and 4) Grade 3 thrombocytopenia. Grade 4 toxicities resulting in a treatment breaks > 7 days were considered DLTs.|Adverse event assessments occurred weekly on treatment; The observation period for DLT evaluation incorporated the 7 weeks of treatment.|The analysis dataset is comprised of all treated patients in the dose escalation cohorts.While no DLTs were observed in the first 3 DL 1 patients, the cohort was expanded to 6 patients due to safety and tolerability concerns. Upon further review, it was resolved that the Abraxane dose should not be increased in the setting of concurrent Erbitux.|||Participants with DLT|||Number
2792978|NCT00570674|Primary|Abraxane Maximum Tolerated Dose (MTD) [Phase I]|The Abraxane MTD in combination with carboplatin and concurrent IMRT is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of participants experience a DLT. If no DLTs are observed then the MTD is not reached but the highest dose may then be the recommended phase II dose.|Adverse event assessments occurred weekly on treatment; The observation period for MTD evaluation incorporated the 7 weeks of treatment.|The MTD was not reached on this trial but the recommended phase II dose was the highest dose of Abraxane evaluated.|||mg weekly|||Number
2792979|NCT00570531|Secondary|The Proportion of Toxicities Experienced by Participants|To assess the toxicity of this regimen.|Every three weeks for one year|The study was unable to accrue the number of patients necessary to analyze the objective.||||||
2792980|NCT00570531|Secondary|The Number of Patients Cancer Free at the Time of Surgery|Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.|1 year|The study was unable to accrue the number of patients necessary to analyze the objective.||||||
2792981|NCT00570531|Primary|Disease Free Survival Time|The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.|5 years|The study was unable to accrue the number of patients necessary to analyze the primary objective.||||||
2792982|NCT00570505|Post-Hoc|Change in Quality of Life (5 Years)|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 5 years in IWQOL-Lite Total Score is reported.|5 years|Intent-to-treat (ITT)|||units on a scale||Standard Deviation|Mean
2794135|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2792985|NCT00570505|Post-Hoc|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation|The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2.|5 years|Intent-to-treat (ITT)|||percentage of subjects||95% Confidence Interval|Number
2792986|NCT00570505|Secondary|Change in Quality of Life|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.|12 months|Intent-to-treat (ITT)|||units on a scale||Standard Deviation|Mean
2792987|NCT00570505|Secondary|Change in Comorbid Conditions Related to Obesity|"Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as none on a severity scale of none, mild, moderate, or severe) 12 months after implantation."|12 months|Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)|||percentage of subjects|||Number
2792988|NCT00570505|Secondary|Percent Weight Loss|Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.|Baseline through 12 months|Intent-to-treat (ITT)|||percentage of weight loss||Standard Deviation|Mean
2792989|NCT00570505|Primary|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation|The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.|One year|Intent-to-treat (ITT)|||percentage of subjects|||Number
2792990|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color|Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
2792991|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)|Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
2792992|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins|Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
2792993|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite|Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||participants|||Number
2792994|NCT00570492|Secondary|Mean Values for Urine Specific Gravity|Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||ratio||Standard Deviation|Mean
2792995|NCT00570492|Secondary|Mean Values for Urine pH|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2792996|NCT00570492|Secondary|Mean Hematology Values for Red Blood Cells (RBCs)|RBCs was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Trillion (10^12) cells (Ti)/L||Standard Deviation|Mean
2794136|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2792997|NCT00570492|Secondary|Mean Values for Hematocrit|Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Percentage of BV occupied by RBCs||Standard Deviation|Mean
2792998|NCT00570492|Secondary|Mean Values for Hemoglobin|Hemoglobin was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||g/L||Standard Deviation|Mean
2792999|NCT00570492|Secondary|Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts|Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Giga (10^9) cells (Gi)/L||Standard Deviation|Mean
2793000|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Millimoles (mmol)/L||Standard Deviation|Mean
2793001|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Micromoles (µmol)/L||Standard Deviation|Mean
2793002|NCT00570492|Secondary|Mean Values for the Laboratory Parameters if Albumin and Total Protein|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2793003|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.|||International Units per liter (IU/L)||Standard Deviation|Mean
2793004|NCT00570492|Secondary|Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results|NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (>=1 nostril).|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.|||participants|||Number
2793005|NCT00570492|Secondary|Mean 24-hour Urinary Free Cortisol Excretion|Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval.|Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)|Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value <1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.|||Micrograms per 24 hours (mcg/24 hours)||Standard Deviation|Mean
2793006|NCT00570492|Primary|Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period|Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period|||Centimeters per year (cm/year)||Standard Error|Least Squares Mean
2793079|NCT00569803|Secondary|Number of Participants With Physical Examination Abnormalities|All clinically significant deviations from normal physical examinations were reported.|Days 1, 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
2793007|NCT00570401|Primary|Determine the Overall Objective Response|To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.|2 years||||participants|||Number
2793008|NCT00570362|Primary|Total Glutathione Levels|Subjects were instructed to fast from midnight to 8 AM on the morning of the test. All blood samples were obtained by a qualified registered nurse in the morning, between 8 and 10 AM.|Once in the morning.||||nmol||Standard Deviation|Mean
2793009|NCT00570349|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Decrease in forced expiratory volume in 1 second was measured through spirometer. Spirometer measures the volume of air inspired and expired by the lungs.|Baseline and 48 hours||||Liters||Standard Deviation|Mean
2793010|NCT00570349|Primary|Change in Oxygen Saturation|"Safety and tolerability of drug assessed by decreased oxygen saturation was measured through pulse oximeter, which measure the amount of oxygen in the blood.~Normal range percentage is 95 - 100%"|Baseline and 48 hours||||Percent of oxygen saturation||Standard Deviation|Mean
2793011|NCT00570349|Primary|Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels|Methemoglobin level assessments were measured through blood draws - hematology. This test measures the amount of methemoglobin (a type of hemoglobin that is unable to transport oxygen to tissues) in blood. Normal methemoglobin percentage range 1% - 2%.|Baseline and 48 hours||||Percent of Methemoglobin Level||Standard Deviation|Mean
2793012|NCT00570323|Secondary|Pathologic Complete Response|Pathologic response was defined as no residual invasive tumor on histopathological analysis in the breast primary. Patients were assessed according to the Chevallier classification of pathologic response.|1 Year|Patients who had surgery in the study were evaluable. 13 patients who did not have surgery were excluded from the analysis: 7 patients did not complete study treatment, another 6 patients did not have surgery performed.|||Participants|||Count of Participants
2793013|NCT00570323|Secondary|Clinical Response|Measurable lesions were examined at baseline to treatment completion.Clinical Response was defined by Solid Tumor Response Criteria (RECIST).|1 Year|Patients who completed the study treatment were evaluable. 7 patients who did not complete the treatment were excluded from the analysis.|||Participants|||Count of Participants
2793014|NCT00570323|Primary|Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples|The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.|baseline (pre) to day 28 (post)|Patients were evaluable if their baseline and day28 samples were collected and the samples werer in good quality. 30 patients were excluded from the analysis: 12 patients did not provide the samples at baseline and/or day28; another 18 patients' samples were found with no tumor.|||log-transformed Ki67%||Standard Deviation|Mean
2793015|NCT00570310|Secondary|'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study|Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)|6 Weeks|Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.|||Days||Full Range|Least Squares Mean
2793016|NCT00570310|Primary|Daily Evening Patient Reported Pain Intensity Scores|Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)|Baseline and 6 Weeks|Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.|||Units on a Scale||Full Range|Least Squares Mean
2793017|NCT00570258|Secondary|Number of Participants Achieving Either Complete Response or Partial Response|evaluate response rate and the clinical benefit of fulvestrant alone or in combination with erlotinib|through study completion, an average of 3 years|Early termination due to a change in drug FDA approval. Outcome measures not computed on collected data because data would not be statistically relevant. No data analysis was completed. No data collected.||||||
2793018|NCT00570258|Primary|Number of Participants With Progression-free Survival|This will be defined as the date from randomization onset to first documented occurrence of PD. Death will be regarded as a progression event in those subjects who die before disease progression. Subjects without documented objective progression at the time of the final analysis will be censored at the date of their last tumor assessment.|through study completion, an average of 3 years|Early termination due to a change in drug FDA approval. No subject completed study. No data analysis was completed. No data collected.||||||
2793019|NCT00570232|Secondary|Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.|Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy|12 - 24 months||||percentage of participants|||Number
2793020|NCT00570232|Primary|Percentage of Participants With Disease Free Status at 12 Months and 24 Months|Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)|12 - 24 months||||percentage of participants|||Number
2793021|NCT00570232|Primary|Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|12 - 24 months||||participants|||Number
2793022|NCT00570141|Primary|Percent Wounds Closed|"Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.~The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU)."|baseline and 12 weeks|Analysis was Per Protocol|||Percent of Wounds Closed|||Number
2793574|NCT00566098|Primary|Feasibility of MILs Generation as Assessed by Percentage of Participants With Successful MIL Generation|Success rate of expanding MILs in vitro and obtaining a protocol-specified product.|Up to 1 year||||percentage of participants|||Number
2793023|NCT00570141|Primary|Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.|"Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.~The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.~Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)"|Baseline and weekly up to 12 weeks|Analysis was Per Protocol|||cm2||Standard Deviation|Mean
2793024|NCT00570089|Secondary|Seattle Angina Questionnaire (SAQ)|"Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period.~The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.~Each final SAQ domain ranges from 0-100, where higher is a better outcome score. Subscales are not combined. Median, SD and range are calculated for each domain."|4 weeks and 10 weeks||||units on a scale||Full Range|Median
2793025|NCT00570089|Primary|Cardiac Magnetic Resonance (CMRs)|Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 4th week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion defect in percentage.|4 weeks and 10 weeks||||Percentage of ischemic myocardium||Full Range|Median
2793026|NCT00570063|Other Pre-specified|Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg)||Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21|Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.||||||
2793027|NCT00570063|Other Pre-specified|Area Under the Concentration Time Curve (AUC) of PF-02545920|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21|Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient PK sampling to support development of a model to calculate the PK parameters.||||||
2793028|NCT00570063|Other Pre-specified|Oral Clearance (CL/F) of PF-02545920|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21|Data was not collected for this outcome measure, due to early termination of the study and the limited number of participants dosed with PF-02545920 resulted in insufficient pharmacokinetic (PK) sampling to support development of a model to calculate the PK parameters.||||||
2793029|NCT00570063|Other Pre-specified|Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21|SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake. Score ranging from 1 to 7, where higher score indicates more sleepiness.|Baseline (Day 1), Day 4, 7, 14, 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2793030|NCT00570063|Other Pre-specified|Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21|ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions). It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia. Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2793031|NCT00570063|Other Pre-specified|Change From Baseline in Abdominal Girth at Day 21||Baseline (Day 1), Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||centimeter||Standard Deviation|Mean
2793032|NCT00570063|Other Pre-specified|Change From Baseline in Body Weight at Day 21||Baseline (Day 1), Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||kilogram||Standard Deviation|Mean
2793033|NCT00570063|Other Pre-specified|Number of Participants With Abnormal Fasting Insulin Level|Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal. Number of participants with abnormal values of fasting insulin level were reported.|Baseline (Day 1) up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2793034|NCT00570063|Other Pre-specified|Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level|Number of participants with abnormal values (>1.3* ULN) of HbA1c level were reported.|Baseline (Day 1) up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication. Here, ‘N’ signifies those participants who were evaluable for this measure.|||participants|||Number
2793035|NCT00570063|Other Pre-specified|Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level|Number of participants with abnormal values of HDL level <0.8* LLN and LDL level >1.2*ULN were reported.|Baseline up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793036|NCT00570063|Other Pre-specified|Number of Participants With Abnormal Prolactin Level|Number of participants with abnormal values (>1.1* ULN) of prolactin level were reported.|Baseline (Day 1) up to Day 21|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793080|NCT00569803|Secondary|Number of Participants With Injection Site Reactions|Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.|0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116|All treated participants|||participants|||Number
2793037|NCT00570063|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: <0.8*lower limit of normal (LLN), platelet: <0.5*LLN or >1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil: <0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte: >1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: > 3.0*ULN, total protein, albumin: <0.8*LLN or>1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; cholesterol (HDL <0.8*LLN, LDL >1.2*ULN); sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; prolactin >1.1*ULN; glucose <0.6*LLN or >1.5*ULN, glycosylated hemoglobin >1.3*ULN, creatine kinase >2.0*ULN; urine (pH <4.5 or >8, glucose, ketone, protein, blood/Hgb >=1, RBC, WBC >=6).|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793038|NCT00570063|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|Criteria for ECG values for potential clinical concern: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >100 msec, and >=50 percent increase when baseline <=100 msec; QTcB interval (corrected QT interval using Bazett's formula) >=500 msec.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793039|NCT00570063|Other Pre-specified|Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities|Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems. Clinical significance was based on the investigator's discretion.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793040|NCT00570063|Other Pre-specified|Number of Participants With Vital Signs of Potential Clinical Concern|Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (<) 40 or greater than (>) 120 beats per minute (bpm), pulse rate in standing position <40 or >140 bpm; systolic blood pressure (SBP) <90 millimeters of mercury (mm Hg) and greater than or equal to (>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) <50 mm Hg and >=20 mm Hg change (increase, decrease) from baseline in same posture.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793041|NCT00570063|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 31|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2793042|NCT00570063|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21|GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning. It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793043|NCT00570063|Secondary|Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21|NOSIE is an inpatient treatment staff-administered questionnaire. It consists of 30 items: 26 items divided into 6 subscales and 4 individual items. Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants. 6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4). For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793044|NCT00570063|Secondary|Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21|CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse). Higher score indicating less improvement.|Baseline (Day 4), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793045|NCT00570063|Secondary|Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21|CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia. Score range: 1 (normal - not ill at all) to 7 (most extreme illness). Higher score indicating greater degree of illness.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793081|NCT00569803|Secondary|Number of Participants With Vital Sign Abnormalities|Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.|1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116|All treated participants|||participants|||Number
2793046|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score|BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia. The scale consists of 18 items. Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe). BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793047|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793048|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793049|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793050|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793051|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score|PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia. PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793052|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology). PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793053|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793115|NCT00569582|Primary|Decrease in Diastolic Blood Pressure.|Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.|Baseline to Week 24||||participants|||Number
2793054|NCT00570063|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior. It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe). PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|PD analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793055|NCT00570063|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score|PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms.|Baseline (Day 1), Day 21|Pharmacodynamic data (PD) analysis set included all participants with at least 1 dose of study medication and had a baseline value and at least 1 post dose PD measurement.|||units on a scale||Standard Deviation|Mean
2793056|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns|The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum||||Percentage of All Household Contacts|||Number
2793057|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Fathers of Newborns|The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum||||Percentage of Fathers of Newborns|||Number
2793058|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Mothers of Newborns|The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period|Pregnancy period through 6 to 8 weeks postpartum||||Percentage of Participants|||Number
2793059|NCT00569946|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.|Up to 1709 days of treatment plus 28-days follow-up|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
2793060|NCT00569946|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
2793061|NCT00569946|Secondary|Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
2793062|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
2793063|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
2793064|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.|||pg/mL||Full Range|Median
2793065|NCT00569946|Secondary|Number of Participants Analyzed for Population Pharmacokinetics of AG-013736|Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.|Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose|No population pharmacokinetic analysis results are available just for the current study.||||||
2793066|NCT00569946|Secondary|Overall Survival (OS)|"OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.~Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive."|Up to 2002 days (maximum duration of treatment plus follow-up observation)|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2793077|NCT00569803|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (*10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx).~Leukocytes (*10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre-Rx>ULN, use >1.15*Pre-Rx or <LLN) Neutrophils+Bands (*10^3 c/uL): <=1.500. Lymphocytes (*10^3 c/uL): <0.750 or >7.500. Monocytes (*10^3 c/uL): >2.000. Basophils (*10^3 c/uL): >0.400. Eosinophils (*10^3 c/uL): >0.750."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
2793067|NCT00569946|Secondary|Duration of Response|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication. DR was calculated for the subgroup of participants with a confirmed objective tumor response. n=number of participants assessed as CR or PR.|||months||95% Confidence Interval|Median
2793068|NCT00569946|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2793069|NCT00569946|Secondary|Progression-Free Survival (PFS)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2793070|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2793071|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2793072|NCT00569868|Primary|Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.|"Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment.~Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute's guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle.~Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response."|60 days|no analysis done, descriptive information on the magnitude, direction, and variability of changes in coagulation factors and platelet function in refractory/relapsing multiple myeloma patients during VELCADE treatment was collected|||participants|||Number
2793073|NCT00569855|Primary|Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively|Number of subjects who required Norepinephrine >0.1mcq/kg/min|72 hours postoperatively|No. of subjects consented = 832; 785 subjects received study drug|||participants|||Number
2793074|NCT00569803|Secondary|Number of Participants With Positive Immunogenicity to Belatacept|The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.|Days 1, 14, 28, 42, 56, 86, 116|All participants treated with Belatacept|||participants|||Number
2793075|NCT00569803|Secondary|Number of Participants With Marked Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Glucose (mg/dL): <0.8*LLN, >1.5*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN).~Protein (grams per deciliter: g/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).~Albumin (g/dL): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mg.dL): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)"|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
2793076|NCT00569803|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (mg/dL): >1.33*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): <0.95*LLN, >1.05*ULN (if Pre-Rx<LLN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN).~Potassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).~Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN)."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants|||participants|||Number
2793082|NCT00569803|Secondary|Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption|"AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug*h/mL).~AUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.~AUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time."|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug*h/mL||90% Confidence Interval|Geometric Mean
2793083|NCT00569803|Primary|Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept|Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept|||Liters||Geometric Coefficient of Variation|Geometric Mean
2793084|NCT00569803|Primary|Volume of Distribution at Steady State (VSS) for IV Belatacept|Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept|||Liters||Standard Deviation|Mean
2793085|NCT00569803|Primary|Total Body Clearance (CLT) of IV Belatacept|Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2793086|NCT00569803|Primary|Apparent Total Body Clearance (CLT/F) of SC Belatacept|Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2793087|NCT00569803|Primary|Serum Half-life (T-HALF) of Belatacept|Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||hours||Standard Deviation|Mean
2793088|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept|Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug*h/mL||90% Confidence Interval|Geometric Mean
2793089|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept|Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug*h/mL||90% Confidence Interval|Geometric Mean
2793090|NCT00569803|Primary|Time of Maximum Observed Serum Concentration (Tmax) of Belatacept|Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||hours||Full Range|Median
2793091|NCT00569803|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2793092|NCT00569777|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Eyes|Participants||Number
2793093|NCT00569777|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes.|||Units on a scale|Participants|Standard Deviation|Mean
2793094|NCT00569777|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes.|||Units on a scale|Participants|Standard Deviation|Mean
2793095|NCT00569777|Primary|Intraocular Pressure, Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||mm of mercury|Participants|Standard Deviation|Mean
2793096|NCT00569777|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793097|NCT00569777|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793098|NCT00569777|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793099|NCT00569777|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793100|NCT00569777|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793101|NCT00569777|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793102|NCT00569777|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793103|NCT00569777|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793104|NCT00569777|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Analysis includes subjects that completed the 12 week visit per protocol.|||Units on a scale|Participants|Standard Deviation|Mean
2793105|NCT00569777|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793106|NCT00569777|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793107|NCT00569777|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793108|NCT00569777|Primary|Conjunctival Redness, Change From Baseline|Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793109|NCT00569777|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793110|NCT00569777|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
2793111|NCT00569673|Secondary|Duration of Progression-free Survival and Overall Survival||up to 5 years|||||||
2793112|NCT00569673|Primary|Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Prior to each cycle and 30 days after the last cycle (average of 5 months)|Eligible and treated patients|||Participants|||Count of Participants
2793113|NCT00569673|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6"|every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)|Total number eligible and evaluable|||participants|||Number
2793114|NCT00569660|Primary|Number of Participants With Objective Clinical Response|Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.|Every 2 courses of 4 week therapy = each 8 weeks|The statistical analysis for response rates determined on the intent-to-treat (ITT) populations. This is defined as all enrolled patients who received at least one dose of study medication.|||Participants|||Number
2793116|NCT00569582|Primary|Improvement in Diabetes and/or Glucose Intolerance.|Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.|Baseline to Week 24|Patients with at least 30 days of dosing.|||participants|||Number
2793117|NCT00569530|Secondary|Alive Without BPD at 36 Weeks Post Menstrual Age|Alive without need for oxygen at 36 weeks post menstrual age.|36 Weeks Post Menstrual Age||||Number of infants|||Number
2793118|NCT00569530|Primary|SP-B Content|SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.|One day after dose|24 of 43 in the Treatment Group and 18 of 42 in the Sham group had samples analyzed. SpB content recorded as a percentage of Total Phospholipids.|||Total surfactant protein (% of PL)||Full Range|Mean
2793119|NCT00569374|Secondary|Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.|The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.|Thrice weekly for the first three weeks|The data reported was obtained by computing the overall mean numerical score on the Amphetamine Withdrawal Questionaire for each participant, then using these to compute the overall mean. The scale consists of 13 items ranging from 0 (none) to 4 (worst). The total score ranges from 0 (least) to 52 (worst).|||units on a scale||Standard Deviation|Mean
2793120|NCT00569374|Primary|Depression as Measured by the Hamilton Depression Scale|Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Depression Scale for each participant, then using these to compute the overall mean. It is a 22 item scale of which 13 items have a score of 0 (none) to 4 (worst) and 9 have a score of 0 (none) to 2 (worst). The total score ranges from 0 (least) to 70 (worst).|||units on a scale||Standard Deviation|Mean
2793121|NCT00569374|Primary|Anxiety as Measured by the Hamilton Anxiety Scale|Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Anxiety Scale for each participant, then using these to compute the overall mean. The scale is a 14 item instrument with each item scoring a potential range of 0 (none) to 4 (worst). The potential total scores range form 0 (least) to 56 (worst).|||units on a scale||Standard Deviation|Mean
2793122|NCT00569374|Primary|"Modafinil Side Effects Checklist"|"Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from not at all (0) to very much (4). The score was determined by units on a scale."|Weekly for 7 weeks|The data reported was obtainined by computing the overall mean numberical score on the Modafinil Side Effects Checklist for each participant, then using these to compute the overall mean. The checklist is a 10 item scale with each item scoring between 0 (none) to 4 (worst). The potential scores range from 0 (least) to 40 (worst).|||units on a scale||Standard Deviation|Mean
2793123|NCT00569374|Primary|Diastolic Blood Pressure|Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean diastolic blood pressure for each participant, then using these to compute the overall mean.|||mmHg||Standard Deviation|Mean
2793124|NCT00569374|Primary|Systolic Blood Pressure|Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean systolic blood pressure for each participant, then using these to compute the overall mean.|||mmHg||Standard Deviation|Mean
2793125|NCT00569374|Primary|Heart Rate|Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean heart rate for each participant, then using these to compute the overall mean.|||beats per minute||Standard Deviation|Mean
2793126|NCT00569309|Secondary|Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials||Up to 3 years|Data was not collect and analyzed for reporting purposes||||||
2793127|NCT00569309|Secondary|Quality of Life, Including Fatigue|Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine.|Up to 3 years||||units on a scale||Standard Deviation|Mean
2793128|NCT00569309|Secondary|Quality of Life, Including Brief Pain Inventory|The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine.|Up to 3 years|Not all patients data was available due to incomplete surveys|||units on a scale||Standard Deviation|Mean
2793129|NCT00569309|Secondary|Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes||Up to 3 years|Quality of Life surveys were not completed||||||
2793130|NCT00569309|Secondary|Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10)||Up to 3 years|Inadequate material collected to perform these assays||||||
2793131|NCT00569309|Primary|Number of Participants Experiencing Immune Reconstitution|Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma|Up to 2 years||||Participants|||Count of Participants
2793132|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema|baseline to trough tiotropium|High resolution, thin-section scans of the lung were obtained in a subset of 19 patients.|||percentage of lung tissue||Standard Deviation|Mean
2793133|NCT00569270|Primary|TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo|Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium|one hour before intervention & 2 hrs. after after 30 days|lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
2793134|NCT00569270|Primary|IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline|IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo|baseline and 30 days (+2h) post dose|Inspiratory capacity (IC) (mean +/- SD) from baseline and after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
2793135|NCT00569270|Primary|Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|||liters||Standard Deviation|Mean
2793136|NCT00569270|Primary|Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage|||percentage of FRC/TLC||Standard Deviation|Mean
2793137|NCT00569270|Primary|Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters|30 days|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters|||liters||Standard Deviation|Mean
2793138|NCT00569270|Primary|Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|||liters||Standard Deviation|Mean
2793139|NCT00569270|Primary|Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)|30 days|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)|||liters||Standard Deviation|Mean
2793140|NCT00569270|Primary|Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters)|30 days|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|||liters||Standard Deviation|Mean
2793141|NCT00569270|Primary|Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
2793142|NCT00569270|Primary|Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage|||percentage of FRC/TLC||Standard Deviation|Mean
2793143|NCT00569270|Primary|Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo|Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
2793144|NCT00569270|Secondary|IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema|Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema|baseline to 30 days|Analysis was carried out per protocol|||percentage of lung tissue||Standard Deviation|Mean
2793145|NCT00569270|Primary|Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo|Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters|30 days|Peak FVC after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients.|||liters||Standard Deviation|Mean
2794137|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793146|NCT00569270|Primary|Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)|Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients.|30 days|Includes groups randomized to receive placebo first and Tiotropium first.|||Liters||Standard Deviation|Mean
2793147|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium|baseline to 30 days|High-resolution, thin-section scans of the lung were obtained from a subset of 19 patients.|||percentage of lung tissue||Standard Deviation|Mean
2793148|NCT00569270|Primary|Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second|30 days|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second|||liters||Standard Deviation|Mean
2793149|NCT00569231|Other Pre-specified|Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide|Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.|Initial visit to completion of protocol, which is up to 30 weeks|The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.|||Participants|||Number
2793150|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|The participants with 2nd anatomically distant, non-injected wart were analyzed.|||Participants|||Number
2793151|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|Participants with 1st anatomically distant, non-injected wart were analyzed.|||Participants|||Number
2793152|NCT00569231|Primary|Number of Participants With Clinical Resolution of Injected Wart|When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.|Initial visit to completion of protocol, which is up to 30 weeks|The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.|||Participants|||Number
2793153|NCT00569192|Secondary|Change From Baseline in Nighttime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
2793154|NCT00569192|Secondary|Change From Baseline in Daytime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
2793155|NCT00569192|Secondary|Change From Baseline in PEF|The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.|||L/min||Standard Deviation|Mean
2793156|NCT00569192|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
2793174|NCT00569010|Primary|Number of Participants With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery) according to International Working Group (IWG) criteria.|6 weeks|Analysis was per protocol.|||participants|||Number
2793157|NCT00569192|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.|||percentage of predicted FEV1||Standard Deviation|Mean
2793158|NCT00569192|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.|||units on a scale||Standard Deviation|Mean
2793159|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in Symptom Experience Diary From Baseline to Week 9|Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the Symptom Experience Diary item scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||Correlation coefficient|||Number
2793160|NCT00569166|Secondary|Change From Baseline to Week 9 for Symptom Distress Diary|Symptom Experience Diary is a self-report diary of expected side effects from controlled breathing on 10-points scale with 10 represents symptoms all the time. Individual item scores were then transformed into 0 to 100 scale, with 100 indicates best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Standard Deviation|Mean
2793161|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in BFI Fatigue From Baseline to Week 9|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the BFI fatigue items scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||Correlation coefficient|||Number
2793162|NCT00569166|Secondary|Change From Baseline to Week 9 for BFI Fatigue Scores|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Standard Deviation|Mean
2793163|NCT00569166|Secondary|Pearson Correlation Coefficients for Changes in Hot Flash Scores From Baseline to Week 9 With Changes in POMS Total Score and Subscales From Baseline to Week 9|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9. The correlation was estimated using Pearson correlation coefficients. The assessment of the Pearson Correlation Coefficients was the pre-specified Secondary outcome, and not the underlying changes in the POMS scores.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||Correlation coefficient|||Number
2793164|NCT00569166|Secondary|Change From Baseline to Week 9 for POMS Total Score and Subscales|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The total score was the sum of all subscale scores. The scores were then transformed into a 100-point scale with higher numbers indicating best quality of life (QOL). Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Standard Deviation|Mean
2794138|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|12 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793165|NCT00569166|Secondary|Change From Baseline to Week 9 on Blood Pressure Measurement|Participants were taught home monitoring of blood pressure and provided with the sphygmomanometer. The measurements data were recorded on the Blood Pressure Measurement log. Change from baseline to week 9 was calculated by subtracting the baseline measurement from the measurement at week 9.|Baseline and Week 9|Includes all participants who had both baseline and week 9 blood pressure measurements.|||mmHg||Full Range|Median
2793166|NCT00569166|Secondary|Change From Baseline to Week 9 for PSQI Global Score|The Pittsburgh Sleep Quality Index (PSQI) has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The global score is translated into 0-100 scale with high values representing best quality of life (QOL). The habitual sleep efficiency component and global score was estimated using the worst-case scenarios for the values that were provided for PSQI question 4. Change from baseline to week 9 was calculated by subtracting the baseline scores from the scores at week 9.|Baseline and Week 9|Includes all participants who completed both baseline and week 9 assessments.|||units on a scale||Full Range|Median
2793167|NCT00569166|Primary|The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9|Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.|Week 1 and Week 9||||units on a scale||Standard Deviation|Mean
2793168|NCT00569127|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.|||Participants|||Number
2793169|NCT00569127|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.|||participants|||Number
2793170|NCT00569127|Secondary|Local Progression-Free Survival (Investigator Assessed)|From date of randomization (which is the date of registration) to date of first documentation of progression [per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
2793171|NCT00569127|Secondary|Time to Treatment Failure|From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
2793172|NCT00569127|Primary|Central Review-based Progression-Free Survival|From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
2793173|NCT00569127|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 7 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.|||months||95% Confidence Interval|Median
2793175|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks||||% days abstinent||Standard Deviation|Mean
2793176|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline||||% days abstinent||Standard Deviation|Mean
2793177|NCT00568958|Secondary|Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.~BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin's formula."|8 weeks||||percentage of days||Standard Deviation|Mean
2793178|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks||||drinks per drinking day||Standard Deviation|Mean
2793179|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.~Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor)."|eight weeks||||percentage of heavy drinking days||Standard Deviation|Mean
2793180|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline||||drinks per drinking day||Standard Deviation|Mean
2793181|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). Baseline measures captured the prior 4 weeks.|Baseline||||percentage of heavy drinking days||Standard Deviation|Mean
2793182|NCT00568854|Primary|Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination|Blood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.|5 months||||weeks when peak response was observed||Standard Deviation|Mean
2793183|NCT00568854|Primary|Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test|Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.|5 months||||mm||Full Range|Median
2793184|NCT00568802|Secondary|Biomarker Assays: SMN Protein and SMN mRNA||Up to 6 years, 2 months|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793185|NCT00568802|Secondary|Motor Unit Number Estimation (MUNE)||Up to 6 years, 2 months|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793186|NCT00568802|Secondary|Pulmonary Function Testing||Up to 6 years, 2 months|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793187|NCT00568802|Primary|Safety: Frequency of Adverse Events/Lab Abnormalities||Up to 6 years, 2 months|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793188|NCT00568802|Primary|Efficacy: Functional Motor Testing, Including Gross Motor Function Measure (GMFM) and Timed Motor Tests||Up to 6 years, 2 months|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793189|NCT00568776|Secondary|Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
2793190|NCT00568776|Secondary|Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
2793264|NCT00568022|Secondary|Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval|T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||Hours||Standard Deviation|Mean
2793191|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.|||Scores on a Scale||Standard Error|Mean
2793192|NCT00568776|Primary|Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
2793193|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.|||Scores on a Scale||Standard Error|Mean
2793194|NCT00568776|Secondary|Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
2793195|NCT00568776|Primary|Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.|||Scores on a Scale||Standard Error|Mean
2793196|NCT00568698|Secondary|Biomarker Assays: SMN Protein and SMN mRNA||Up to 8 years, 1 month|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793197|NCT00568698|Secondary|Motor Unit Number Estimation (MUNE)||Up to 8 years, 1 month|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793198|NCT00568698|Primary|Efficacy: Length of Survival (LOS) and Age of Ventilator Dependence (AVD)||Up to 8 years, 1 month|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793199|NCT00568698|Primary|Safety: Frequency of Adverse Events/Lab Abnormalities||Up to 8 years, 1 month|Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.||||||
2793200|NCT00568685|Secondary|Weight Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||kilograms (kg)||Standard Deviation|Mean
2793201|NCT00568685|Secondary|Blood Pressure Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||mmHg||Standard Deviation|Mean
2793202|NCT00568685|Secondary|Temperature Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||degrees Celsius||Standard Deviation|Mean
2793203|NCT00568685|Secondary|Heart Rate Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population|||beats per minute (bpm)||Standard Deviation|Mean
2793204|NCT00568685|Secondary|Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary|Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required.|Baseline to Day 42|As treated population|||participants|||Number
2793205|NCT00568685|Primary|Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).|Baseline, Day 42|Analysis included all randomized participants (intent-to-treat population)|||units on a scale||95% Confidence Interval|Least Squares Mean
2793206|NCT00568685|Secondary|Adverse Events Leading to Discontinuation|Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency|Baseline to Day 42|As-treated population|||events|||Number
2793207|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|Baseline, Days 7, 14, 42|ITT population; LOCF|||units on a scale||Standard Deviation|Mean
2793208|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, Days 7, 14, 42|ITT population; last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2793209|NCT00568633|Secondary|Patients Completing the Intended Therapy in Both Arms|The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion|2 years||||percentage of participants|||Number
2793210|NCT00568633|Secondary|Early Graft Loss|Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion.|2 years|Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.|||percentage of participants|||Number
2793211|NCT00568633|Secondary|Complete Donor Hematopoietic Cell Chimerism|Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion.|2 years|Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.|||percentage of participants|||Number
2793212|NCT00568633|Secondary|Transplant-related Mortality|Transplant-related mortality will be assessed as any death occurring within 6 months post-transplant, from any cause except relapse. It will be measured at 100 day and 6 months after transplant. The outcome is expressed as at the number of participants experiencing transplant-related mortality (a number without dispersion).|100 days and 6 months|Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.|||Participants|||Count of Participants
2793213|NCT00568633|Secondary|Relapse Rate|Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion).|2 years||||Participants|||Count of Participants
2793214|NCT00568633|Secondary|Non-relapse Mortality|Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion).|2 years||||Participants|||Count of Participants
2793215|NCT00568633|Secondary|Disease-free Survival (DFS)|Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion).|2 years||||Participants|||Count of Participants
2793216|NCT00568633|Primary|Overall Survival (OS)|Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).|2 years||||Participants|||Count of Participants
2793217|NCT00568555|Secondary|Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline to final||95% Confidence Interval|Mean
2793218|NCT00568555|Secondary|Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline to final||95% Confidence Interval|Mean
2793219|NCT00568555|Secondary|Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for fatigue, 0 to 100, where 0 = no fatigue at all and 100 = severe fatigue.~Baseline fatigue calculated averaging daily scores over the 2 week baseline period.~Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition.~Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline||95% Confidence Interval|Mean
2793220|NCT00568555|Secondary|Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for sleep quality, 0 to 100, where 0 = did not sleep well at all and 100 = slept extremely well.~Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period.~Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition.~Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline||95% Confidence Interval|Mean
2793221|NCT00568555|Primary|Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable.~Baseline pain calculated averaging daily pain scores over the 2 week baseline period.~Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition.~Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers|||percentage change from baseline to final||95% Confidence Interval|Mean
2795646|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients|||Participants|||Number
2793222|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment|For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.||||||
2793223|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment|For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.|up to 2 years|There is not enough participants to perform this analysis.||||||
2793224|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment|Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.||||||
2793225|NCT00568451|Secondary|Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response|Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.|up to 2 years|Two complete tumor responses were documented. Both participants have since discontinued the study drug after 35 and 24 cycles respectively, and remain disease-free at 39 and 31.5 months since study entry. There is not enough participants to perform this analysis.||||||
2793226|NCT00568451|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause.|up to 2 years||||Months||95% Confidence Interval|Median
2793227|NCT00568451|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 2 years||||Days||95% Confidence Interval|Median
2793228|NCT00568451|Primary|Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|"Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.~CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs."|Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment|All subjects enrolled, met the eligibility criteria who have signed a consent form and have begun their study treatment were evaluable for response.|||participants|||Number
2793229|NCT00568399|Primary|Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.|We will compare the annualized coronary calcium volume score obtained at the baseline CT of the coronary arteries with another CT obtained of the same coronary arteries following 5 months of sodium thiosulfate treatment.|5 months|This is a feasibility study and all eligible participants were invited to participate. Out of the 48 participates that started, but only 22 completed.|||mm3/year||Standard Deviation|Geometric Mean
2793230|NCT00568386|Primary|Visual Blur|Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.|3 minutes post dose||||Units on a scale||Full Range|Mean
2793231|NCT00568334|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to study end (Day 86-114)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2793232|NCT00568334|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2793233|NCT00568334|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fever [defined as axillary fever ≥ 37.5 degrees Celsius (°C)] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (>) 39.0°C after vaccination. Grade 3 rash = more than (>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
2793265|NCT00568022|Secondary|Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval|AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2793234|NCT00568334|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
2793235|NCT00568334|Secondary|Antibody Concentrations Against Varicella Zoster Virus (VZV)|Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].|At 86-114 days after the second vaccine dose (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2793236|NCT00568334|Secondary|Antibody Titers Against Varicella Zoster Virus (VZV)|Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].|At 86-114 days after the second vaccine dose (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
2793237|NCT00568334|Secondary|Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values|Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.|At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
2793238|NCT00568334|Secondary|Number of Seroconverted Subjects for Varicella Antibodies|Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies [i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4] in the sera of subjects who were seronegative before vaccination.|At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
2793239|NCT00568334|Primary|Antibody Concentrations Against Varicella Zoster Virus (VZV)|Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects [with anti-VZV concentration below (<) 25 mIU/mL].|At 43-57 days after the first vaccine dose (Week 6)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2793240|NCT00568334|Primary|Antibody Titers Against Varicella Zoster Virus (VZV)|Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects [with anti-VZV titer below (<) 1:4].|At 43-57 days after the first vaccine dose (Week 6)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
2793241|NCT00568178|Primary|Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36|"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:~GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)~GFR values were compared to the baseline GFR measure.~[Note: For male participants, ages 13 to 17 years, 0.70 was used as~the multiplier in place of 0.55]~Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only individuals who satisfied the criteria.|||Change in GFR mL/min1.73m^2||95% Confidence Interval|Least Squares Mean
2793242|NCT00568178|Primary|Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.~*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only the individuals who satisfied the criteria.|||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
2793243|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received|||mm Hg||95% Confidence Interval|Least Squares Mean
2793244|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received.|||mm Hg||95% Confidence Interval|Least Squares Mean
2793245|NCT00568178|Primary|Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.~Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period."|Baseline and Week 12|Full Analysis Set included all randomized participants who took at least one dose of study drug and had baseline and post randomization measurements available|||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
2793246|NCT00568087|Secondary|Liver Function Tests|Aspartate aminotransaminase (AST) plasma level|8 weeks||||U/L||Standard Deviation|Mean
2793247|NCT00568087|Secondary|The Obsessive Compulsive Drinking Scale|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving."|The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.||||score on a scale||Standard Error|Mean
2793248|NCT00568087|Secondary|The Penn Alcohol Craving Scale|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving."|The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.||||score on a scale||Standard Error|Mean
2793249|NCT00568087|Primary|Alcohol Consumption (Percentage of Heavy Drinking Days)|The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.|The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.|All 44 subjects who received intervention were included in analysis.|||percentage of heavy drinking days||Standard Error|Mean
2793250|NCT00568061|Secondary|Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole||4 months|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793251|NCT00568061|Secondary|Troponin T Levels and CPK-MB Area Under the Curve||48 hours|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793252|NCT00568061|Secondary|Resolution of ST Segment Elevation Compared With That Observed at Enrollment||4 hours|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793253|NCT00568061|Secondary|MI Size as a Fraction of LV Size||4 months|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793254|NCT00568061|Secondary|Change in Global LV Function and Mass||between 48-72 hours and 4 months|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793255|NCT00568061|Secondary|Global & Regional Left Ventricular (LV) Function and LV Mass||48-72 hours and 4 months|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793256|NCT00568061|Secondary|Infarct Transmurality||48-72 hours and 4 months|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793257|NCT00568061|Secondary|Myocardial Perfusion at Coronary Angiography||at completion of primary coronary intervention (PCI)|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793258|NCT00568061|Secondary|MI Size Normalized to Area at Risk||48-72 hours|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and CSR are no longer accessible.||||||
2793259|NCT00568061|Secondary|Myocardial Infarction (MI) Size at 48-72 Hours||48-72 hours|All efforts have been exhausted to locate data for this historical trial - the validated summary tables and Clinical Study Report (CSR) are no longer accessible.||||||
2793260|NCT00568061|Primary|Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size|The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).|48-72 hours|Analysis was per intent to treat population|||percent of myocardial infarction size||Standard Deviation|Mean
2793261|NCT00568022|Primary|Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)|The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.|At the end of Cycle 2 (Day 42)|All participants treated at the highest dose level.|||Participants|||Number
2793262|NCT00568022|Secondary|Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval|CLT = total body clearance as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||L/h||Standard Deviation|Mean
2793263|NCT00568022|Secondary|Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval|Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||Liters||Standard Deviation|Mean
2793266|NCT00568022|Secondary|Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2793267|NCT00568022|Secondary|Participant Tumor Response at Study Endpoint|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria.|At baseline and after every 42 days (every 2 21-day cycles) after baseline|All treated participants with measurable disease and tumor response.|||Participants|||Number
2793268|NCT00568022|Secondary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug|Baseline to Day 42, continuously|All participants who received at least 1 dose of either ixabepilone or capecitabine.|||Participants|||Number
2793269|NCT00568022|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.|From initiation of drug through last day of Cycle 2 (Day 42)|All participants who received at least 1 dose of either ixabepilone or capecitabine.|||Participants|||Number
2793270|NCT00567996|Secondary|"Percentage of COPD Days of Poor Control During 26 Weeks of Treatment"|"Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of days of poor control, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates."|Up to 26 weeks|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.|||Percentage of days||Standard Error|Least Squares Mean
2793271|NCT00567996|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had SGRQ data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).|||Score on a scale||Standard Error|Least Squares Mean
2793272|NCT00567996|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The end point was analyzed only for those participants who had Trough FEV1 data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2793273|NCT00567892|Secondary|Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater|"PGIC is a 7 point scale ranging from -3 to +3,with 0 meaning no change,negative values reporting worsening of symptoms(Tinnitus), and values of +1 or above reporting perceived improvement of Tinnitus.~PGIC score post active rTMS treatment treatment will provide subject's impression of change in tinnitue due to active treatment.PGIC score post rTMS sham will provide subject's impression of change in tinnitus due to sham. Number of subjects with scores of 1 or above are recorded to perceive improvement due to treatment of the corresponding study arm."|End of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.|||participants|||Number
2793274|NCT00567892|Primary|Change in THI (Tinnitus Handicap Inventory)|Tinnitus Handicap Inventory (THI) is a measure of bother from tinnitus. THI is measured as a score in a scale ranging from 0=No bother to 100=Extremely Bothered. THI score post active rTMS treatment minus THI score pre active rTMS treatment will provide the change in THI score due to active treatment. THI score post rTMS sham minus THI score pre rTMS sham will provide change in THI due to sham. The difference of THI change due to active treatment minus THI change due to sham will provide the THI change that is our primary outcome measure.|baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.|||units on a scale||95% Confidence Interval|Median
2793292|NCT00567567|Secondary|Intraspinal Extension|Percentage of patients with primary tumors with intraspinal extension.|Up to 5 years|All eligible patients enrolled on ANBL0532.|||Percentage of patients|||Number
2793293|NCT00567567|Secondary|Type of Surgical or Radiotherapy Complication|The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea.|Up to 3 years|All eligible patients enrolled on ANBL0532.|||Percentage of patients|||Number
2793294|NCT00567567|Secondary|Surgical Response|Percentage of patients who achieved a surgical complete resection|Up to 3 years|All eligible patients enrolled on ANBL0532.|||Percentage of patients|||Number
2793275|NCT00567879|Secondary|Number of Participants With Best Overall Response|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|day 21|The full analysis set was analyzed. The full analysis set included all randomized participants.|||Participants|||Number
2793276|NCT00567879|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.|day 21|The Maximum Tolerated Dose (MTD) determining set was used for this analysis. The MTD determining set consisted of all participants who either received sufficient study drug and had sufficient safety evaluations or discontinued due to unacceptable toxicity.|||Participants|||Number
2793277|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]||Day 2 and Day 14||||hours/day||Standard Deviation|Mean
2793278|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)||Day 0 and Day 2||||hours/day||Standard Deviation|Mean
2793279|NCT00567840|Secondary|EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Day 0 and Day 14||||hours/day||Standard Deviation|Mean
2793280|NCT00567840|Secondary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14).||Day 2 and Day 14|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10 CFU/ml||Standard Deviation|Mean
2793281|NCT00567840|Secondary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2).||Day 0 and Day 2|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10 CFU/ml||Standard Deviation|Mean
2793282|NCT00567840|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||Day 0 and Day 14|Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10 CFU/ml||Standard Deviation|Mean
2793283|NCT00567593|Primary|PDK4 mRNA||14 days||||copies/nL||Full Range|Median
2793284|NCT00567567|Secondary|OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology|Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.|Up to 3 years||||percent probability||95% Confidence Interval|Number
2793285|NCT00567567|Secondary|EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).|Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.|Up to 3 years|All eligible patients non-randomly assigned to single CEM|||percent probability||95% Confidence Interval|Number
2793286|NCT00567567|Secondary|Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique|Will be calculated overall and by treatment arm.|Baseline|Data were not collected to assess this study aim.||||||
2793287|NCT00567567|Secondary|Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells|A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed.|Up to 6 months after completion of assigned myeloablation therapy|All eligible patients that had CD3, CD4 and CD8T-cell count evaluated at the end of reporting period 3.|||cells/mm^3||Full Range|Median
2793288|NCT00567567|Secondary|Presence and Function of T Cells Capable of Recognizing Neuroblastoma||Up to 6 months (end of therapy)|Data were not collected to assess this study aim.||||||
2793289|NCT00567567|Secondary|Topotecan Systemic Clearance|Median topotecan systemic clearance for courses 1 and 2.|Day 1 of courses 1-2|Eligible patients evaluated for topotecan systemic clearance.|||L/h/m2||Full Range|Median
2793290|NCT00567567|Secondary|Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies|To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher's exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles.|At baseline|Data were not collected to assess this study aim.||||||
2793291|NCT00567567|Secondary|Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies|Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532|Day 1 of each course|Eligible patients evaluated for peak serum concentration level of isotretinoin.|||Micromolar||Full Range|Median
2793295|NCT00567567|Secondary|Proportion of Patients With a Polymorphism|A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.|Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days|Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.|||Proportion of patients|||Number
2793296|NCT00567567|Secondary|Duration of Greater Than or Equal to Grade 3 Thrombocytopenia|A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.|Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days|Eligible patients with available polymorphism and thrombocytopenia toxicity data.|||Days||Full Range|Median
2793297|NCT00567567|Secondary|Duration of Greater Than or Equal to Grade 3 Neutropenia|A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.|Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days|Eligible patients with available polymorphism and neutropenia toxicity data.|||Days||Full Range|Median
2793298|NCT00567567|Primary|Incidence Rate of Local Recurrence|Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.|Up to 3 years|Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.|||Percentage 3-year cumulative incidence||95% Confidence Interval|Number
2793299|NCT00567567|Primary|Response After Induction Therapy|Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive.|Study enrollment to the end of induction therapy|Eligible patients evaluated for response at the end of induction therapy.|||Proportion participants that responded||95% Confidence Interval|Number
2793300|NCT00567567|Primary|Event-free Survival Rate|Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)|Three years, from time of randomization|All eligible, randomized patients.|||percent probability||95% Confidence Interval|Number
2793301|NCT00567541|Primary|Relief of Chronic Shoulder Pain|Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.|From baseline to 48 week follow up|Intent to Treat population was analyzed|||participants|||Number
2793302|NCT00567502|Primary|Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events|SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.|Up to 5 years|"Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the Other (Cytoreductives)."|||participants|||Number
2793303|NCT00567502|Secondary|Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy|Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||milligram (mg)||Standard Deviation|Mean
2793304|NCT00567502|Secondary|Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy|Total duration for each participant = sum of [stop date - start date + 1] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||days||Standard Deviation|Mean
2793305|NCT00567502|Secondary|Platelet Count||Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60|Overall Treatment Safety population, Here n = participants evaluable at specified time-points. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||10^9 per Liter (10^9/L)||Standard Deviation|Mean
2794139|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793306|NCT00567502|Secondary|Event Rate of Thrombohaemorrhagic Events|Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.|||participants/100 participant-years|||Number
2793307|NCT00567502|Primary|Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies|Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.|Up to 5 years|First Treatment Safety Population included participants who received cytoreductive therapy at registration. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment.|||percentage of participants|||Number
2793308|NCT00567489|Secondary|Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6|Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent||Standard Deviation|Mean
2793309|NCT00567489|Secondary|Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6|Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||grams||Standard Deviation|Mean
2793310|NCT00567489|Secondary|Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6|Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate),however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mL||Standard Deviation|Mean
2793311|NCT00567489|Secondary|Change From Baseline of MRI Body Composition at Month 6|Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used in this analysis. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mL||Standard Deviation|Mean
2793312|NCT00567489|Secondary|Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6|"The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0."|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Scores on a scale||Standard Deviation|Mean
2793313|NCT00567489|Secondary|Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6|"Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0."|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Score on a Scale||Standard Deviation|Mean
2793333|NCT00567476|Secondary|Free Days With no Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.|From Baseline through 20 weeks (140 days)|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.|||Days||Standard Deviation|Mean
2793314|NCT00567489|Secondary|Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6|European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent Change||Standard Deviation|Mean
2793315|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6|Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||grams||Standard Deviation|Mean
2793316|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6|Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||cm||Standard Deviation|Mean
2793317|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6|Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||kg/m2||Standard Deviation|Mean
2793318|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6|Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||kg||Standard Deviation|Mean
2793319|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6|Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mg/dL||Standard Deviation|Mean
2793320|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6|Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||g/kg/day||Standard Deviation|Mean
2793321|NCT00567489|Secondary|Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6|Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||g/L||Standard Deviation|Mean
2793322|NCT00567489|Secondary|Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6|"Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease.~The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished"|Baseline and Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||participants|||Number
2793323|NCT00567489|Secondary|Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6|Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||pmol/L||Standard Deviation|Mean
2793324|NCT00567489|Secondary|Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6|Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||pg/mL||Standard Deviation|Mean
2793325|NCT00567489|Secondary|Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6|Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mg/dL||Standard Deviation|Mean
2793326|NCT00567489|Secondary|Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6|Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mmol/L||Standard Deviation|Mean
2793327|NCT00567489|Secondary|Number of Severe Hypoglycemic Event Requiring Medical Intervention|Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.|Baseline through Month 6 (End of Study)|Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||events|||Number
2793328|NCT00567489|Secondary|Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6|This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Analysis used data from prescription information of concomitant medications reported. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent Change||Standard Deviation|Mean
2793329|NCT00567489|Primary|Change From the Baseline Value in HbA1c at Month 3 and 6|HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.|||Percent Change||Standard Deviation|Mean
2793330|NCT00567476|Secondary|Patient's Global Assessment of Treatment Effectiveness|"At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale:~Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma"|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.|||Participants|||Number
2793331|NCT00567476|Secondary|Physician's Global Assessment of Treatment Effectiveness|At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.|||Participants|||Number
2793332|NCT00567476|Secondary|Mean Number of Puffs of Rescue Medication Taken Per Day|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population. Number of patients analyzed includes only those patients requiring rescue medication during the study.|||Puffs||Standard Deviation|Mean
2795647|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients|||Participants|||Number
2793334|NCT00567476|Secondary|Percentage of Participants Using Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.|||Percentage of participants||95% Confidence Interval|Number
2793335|NCT00567476|Secondary|Number of Asthma Exacerbation Episodes Per Participant|For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.|From Baseline through 20 weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.|||Participants|||Number
2793336|NCT00567476|Secondary|The Mean Change From Baseline to the End of Study in AQLQ Domain Score|"AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.~The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment."|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Units on a scale||Standard Error|Mean
2793337|NCT00567476|Primary|The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Units on a scale||Standard Error|Mean
2793338|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Percentage of participants||95% Confidence Interval|Number
2793339|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.|||Percentage of participants||95% Confidence Interval|Number
2793340|NCT00567398|Secondary|Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6|Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent||Standard Deviation|Mean
2793341|NCT00567398|Secondary|Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6|Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||grams||Standard Deviation|Mean
2793381|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
2793342|NCT00567398|Secondary|Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6|Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate),however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mL||Standard Deviation|Mean
2793343|NCT00567398|Secondary|Change From Baseline of MRI Body Composition at Month 6|Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used in this analysis. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mL||Standard Deviation|Mean
2793344|NCT00567398|Secondary|Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6|"The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0."|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Scores on a scale||Standard Deviation|Mean
2793345|NCT00567398|Secondary|Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6|"Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0."|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Score on a Scale||Standard Deviation|Mean
2793346|NCT00567398|Secondary|Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6|European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent Change||Standard Deviation|Mean
2793347|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6|Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||grams||Standard Deviation|Mean
2793348|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6|Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||cm||Standard Deviation|Mean
2793349|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6|Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||kg/m2||Standard Deviation|Mean
2793350|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6|Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||kg||Standard Deviation|Mean
2793351|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6|Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mg/dL||Standard Deviation|Mean
2793352|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6|Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||g/kg/day||Standard Deviation|Mean
2793353|NCT00567398|Secondary|Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6|Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||g/L||Standard Deviation|Mean
2793354|NCT00567398|Secondary|Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6|Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished|Baseline and Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||participants|||Number
2793355|NCT00567398|Secondary|Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6|Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||pmol/L||Standard Deviation|Mean
2793356|NCT00567398|Secondary|Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6|Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||pg/mL||Standard Deviation|Mean
2793357|NCT00567398|Secondary|Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6|Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mg/dL||Standard Deviation|Mean
2793358|NCT00567398|Secondary|Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6|Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||mmol/L||Standard Deviation|Mean
2793359|NCT00567398|Secondary|Number of Severe Hypoglycemic Event Requiring Medical Intervention|Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.|Baseline through Month 6 (End of Study)|Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||events|||Number
2793397|NCT00567255|Secondary|Change in Waist Circumference||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
2793360|NCT00567398|Secondary|Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6|This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Analysis used data from prescription information of concomitant medications reported. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).|||Percent Change||Standard Deviation|Mean
2793361|NCT00567398|Primary|Change From the Baseline Value in HbA1c at Month 3 and 6|HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.|Baseline, Month 3, Month 6 (End of Study)|Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.|||Percent Change||Standard Deviation|Mean
2793362|NCT00567359|Secondary|Median Disease Free Survival|The median amount of time measured from the time of registration until the time of disease recurrence or death.|From registration to disease recurrence or death, up to approximately 9 years|Median Disease Free Survival had not been met by the time of data cutoff.|||years||95% Confidence Interval|Median
2793363|NCT00567359|Secondary|Median Overall Survival|The median amount of time from the time of registration until death due to any cause|From the time of registration until death, up to approximately 9 years||||years||95% Confidence Interval|Median
2793364|NCT00567359|Secondary|Number of Participants With Treat Related Serious Adverse Events|Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment.|From the start of treatment until 30 days after the end of treatment, up 13 months total||||Participants|||Count of Participants
2793365|NCT00567359|Primary|2-year Disease-free Survival|The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.|2 years||||Participants|||Count of Participants
2793366|NCT00567320|Primary|Proportion of Cocaine Positive Urine Tests Per Week|Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).|Weekly Measures over 12 weeks|Intention to treat analysis of all subjects receiving medication|||Proportion of cocaine positive||Standard Deviation|Mean
2793367|NCT00567307|Primary|Reduction of the Estimated 10-year Total Cardiovascular Risk Score|Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis. the score is based on systolic blood pressure and total cholesterol measures as well as on medical history data (monthly). Each one of these risk factors is assigned a point in the score and then linked to a table that mention the calculated CVD risk|Six months||||percent||Standard Deviation|Mean
2793368|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy|Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2793369|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance|Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2793370|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2794140|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793371|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2793372|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2793373|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories|Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2793374|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)|Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.|||participants|||Number
2793375|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
2793376|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
2793377|NCT00567268|Secondary|Percent Reduction From Baseline in Epileptic Seizure Frequency|Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100.|12 weeks|The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population.|||Percentage||Standard Deviation|Mean
2793378|NCT00567268|Secondary|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|12 weeks|Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.|||Percentage of participants||95% Confidence Interval|Number
2793379|NCT00567268|Secondary|Response Ratio (R Ratio)|Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.|12 weeks|R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.|||Ratio||Standard Deviation|Mean
2793380|NCT00567268|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population.|||Percentage of participants||95% Confidence Interval|Number
2794141|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|12 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793382|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||participants|||Number
2793383|NCT00567255|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2793384|NCT00567255|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2793385|NCT00567255|Secondary|Change in IDS-SR Total Score|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2793386|NCT00567255|Secondary|Change in Diastolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
2793387|NCT00567255|Secondary|Change in Systolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
2793388|NCT00567255|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2793389|NCT00567255|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2793390|NCT00567255|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2793391|NCT00567255|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2793392|NCT00567255|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2793393|NCT00567255|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2793394|NCT00567255|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2793395|NCT00567255|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 28 weeks||||percent change||95% Confidence Interval|Least Squares Mean
2793396|NCT00567255|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2793398|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2793399|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2793400|NCT00567255|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2793401|NCT00567255|Secondary|Body Weight- Mean Percent Change From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
2793402|NCT00567255|Primary|Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28||Baseline, 28 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
2793403|NCT00567242|Secondary|Category Member Generation Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception of one control subject whose baseline was not stable.|||Z score||Standard Deviation|Mean
2793404|NCT00567242|Secondary|Picture Naming Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception that one control subject was eliminated because of an unstable baseline measure.|||Z score||Standard Deviation|Mean
2793405|NCT00567242|Primary|Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production|Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.|immediately post-treatment scan minus pre-treatment baseline scan|Data for all subjects completing the protocol for their respective arm were analyzed.|||laterality index||Standard Deviation|Mean
2793406|NCT00567229|Primary|Final Response Rate After 4 Courses of Treatment||2 years||||participants|||Number
2793430|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11.|||Percentage of Participants|||Number
2793407|NCT00567190|Secondary|Number of Participants With Laboratory Abnormalities in Hematology Tests by Highest Grade According to NCI-CTCAE v3.0 During the Treatment Period|Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest grade according to NCI-CTCAE v3.0. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. INR = International Normalized Ratio; PTT = partial thromboplastin time; WBC = white blood cell|On Day 1 (and Day 8 for some measures) of every treatment cycle (1 cycle is 21 days) until Treatment Discontinuation Visit (see Description for time on study treatment per arm)|Safety Population: All participants who received at least one dose of any study medication. Only participants with at least one valid laboratory value for any given parameter during the overall study treatment period were included in the analysis.|||Participants|||Count of Participants
2793408|NCT00567190|Secondary|Number of Participants With Laboratory Abnormalities in Blood Biochemistry Tests by Highest Grade According to NCI-CTCAE v3.0 During the Treatment Period|Clinical laboratory tests for blood biochemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest grade according to NCI-CTCAE v3.0. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks. ALP = alkaline phosphatase; GGT = gamma-glutamyl transferase; SGOT = serum glutamic-oxaloacetic transaminase; SGPT = serum glutamic-pyruvic transaminase|On Day 1 of every treatment cycle (1 cycle is 21 days) until Treatment Discontinuation Visit (see Description for time on study treatment per arm)|Safety Population: All participants who received at least one dose of any study medication. Only participants with at least one valid laboratory value for any given parameter during the overall study treatment period were included in the analysis.|||Participants|||Count of Participants
2793409|NCT00567190|Secondary|Baseline LVEF Value and Change in LVEF From Baseline at Maximum Absolute Decrease Value During the Treatment Period|All participants were required to have a left ventricular ejection fraction (LVEF) ≥50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Only data reported prior to the date of first crossover treatment were included for participants who crossed over from placebo to pertuzumab.|Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks)|Safety Population: All participants who received at least one dose of any study medication. Only participants with evaluable LVEF assessments at baseline (BL) or at BL and post-BL (for change in LVEF from BL at max. decrease) were included in the analyses.|||Percentage points of LVEF||Standard Deviation|Mean
2793410|NCT00567190|Secondary|Number of Participants by Categories for the Maximum Absolute Decrease From Baseline in LVEF Value During the Treatment Period|All participants were required to have an left ventricular ejection fraction (LVEF) ≥50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Data reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks.|Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (see Description for time on study treatment per arm)|Safety Population: All participants who received at least one dose of any study medication. Only participants with evaluable LVEF assessments during the overall study treatment period were included in the analysis.|||Participants|||Count of Participants
2793411|NCT00567190|Secondary|Number of Participants Who Experienced at Least One Adverse Event During the Post-Treatment Follow-Up Period|The post-treatment period was defined as the period following the treatment discontinuation visit. Only the following new adverse events (AEs) should have been reported during the post-treatment follow-up period: 1. Cardiac events (regardless of causality or seriousness) that started up to 1 year after the last dose, except for symptomatic left ventricular systolic dysfunction (regardless of causality) that started up to 3 years after the last dose; and 2. Treatment-related serious AEs, regardless of start date. AEs are listed by Medical Dictionary for Regulatory Activities, Version 21.1 (MedDRA v21.1) System Organ Class (SOC) and Preferred Term (PT); PTs fall under the SOC that is listed immediately above it in the table. Multiple occurrences of the same AE in one participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab.|From Day 43 after discontinuation of all study medication to end of post-treatment follow-up period (up to 3 years)|Safety Population: All participants who received at least one dose of any study medication.|||Participants|||Count of Participants
2793454|NCT00567112|Primary|Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements|||nM||Full Range|Least Squares Mean
2793455|NCT00567112|Primary|Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements|||nM*hr||Full Range|Least Squares Mean
2793412|NCT00567190|Secondary|Overall Number of Participants Who Experienced at Least One Adverse Event That Resulted in Interruption or Modification of Any Study Medication|Pertuzumab, trastuzumab, and docetaxel administration could have been delayed to assess or treat adverse events (AEs). Docetaxel dose reduction was allowed for myelosuppression, hepatic dysfunction, and other toxicities. No dose reduction was allowed for pertuzumab or trastuzumab. Multiple occurrences of the same adverse event in one participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks|Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)|Safety Population: All participants who received at least one dose of any study medication.|||Participants|||Count of Participants
2793413|NCT00567190|Secondary|Overall Number of Participants Who Experienced at Least One Adverse Event Leading to Discontinuation of Any or All Study Medication|Participants could continue study treatment with pertuzumab/placebo plus trastuzumab when docetaxel was discontinued due to an adverse event (AE). Discontinuation of pertuzumab/placebo or trastuzumab due to an AE led to discontinuation of all study medication. The number of participants who discontinued any study medication due to an AE includes those who discontinued all study medication and those who discontinued docetaxel only and then continued on targeted therapy (note: some of these participants may have subsequently discontinued all treatment due to a separate AE). Multiple occurrences of the same adverse event in 1 participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for those who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks.|Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)|Safety Population: All participants who received at least one dose of any study medication.|||Participants|||Count of Participants
2793414|NCT00567190|Secondary|Number of Participants Who Experienced at Least One Adverse Event to Monitor (Excluding Cardiac-Related AEs) by Severity During the Treatment Period|The clinical diagnoses listed in this table, excluding cardiac safety (summarized separately), were also selected as adverse events (AEs) to monitor based on clinical and nonclinical data for pertuzumab and the safety profile established for trastuzumab, monoclonal antibodies in general, and potential effects associated with HER receptor inhibition. Search strategies were defined by single or aggregate MedDRA Preferred Terms (PT) through Standardized MedDRA Queries (SMQ), where possible, or based on Roche AE Group Terms (AEGT). Diarrhoea AEs: High-Level Term (HLT) 'Diarrhoea (excl. infective)' and PT 'Diarrhoea infectious'. Leukopenic and Febrile Neutropenic Infections: AEs from 'Infections & Infestations' with start ≤14 days after start date of Grade ≥3 AEs in SMQ(narrow) 'Leukopenia' or PT 'Febrile neutropenia', respectively. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks.|Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)|Safety Population: All participants who received at least one dose of any study medication.|||Participants|||Count of Participants
2793415|NCT00567190|Secondary|Cardiac-Related AEs to Monitor: Number of Participants Who Experienced at Least One Symptomatic Left Ventricular Dysfunction (LVD), Any LVD, or Serious AE Suggestive of Congestive Heart Failure by Severity During the Treatment Period|Cardiac-related adverse events (AEs) to monitor during the study included investigator-assessed symptomatic left ventricular dysfunction (LVD), any LVD, or a serious adverse event (SAE) suggestive of congestive heart failure (CHF). All cardiac-related AEs were graded for severity according to NCI-CTCAE v3.0. Asymptomatic (Grades 1-2) and symptomatic (Grades 3-5) left ventricular systolic dysfunction (LVSD) both coded to the MedDRA preferred term LVD. Investigator-assessed events of symptomatic LVD were also graded for severity of symptoms according to Classes I (least severe) to IV (most severe) of the New York Heart Association (NYHA) Classification. SAEs suggestive of CHF were identified as serious events from the Standardized MedDRA Query (SMQ) (Wide) 'Cardiac Failure'. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks.|Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)|Safety Population: All participants who received at least one dose of any study medication.|||Participants|||Count of Participants
2793416|NCT00567190|Secondary|Overall Number of Adverse Events by Severity (NCI-CTCAE v3.0 All Grades and Grades 3 to 5) Per 100 Patient-Years of Exposure During the Treatment Period|Adverse event (AE) severity, including serious and non-serious AEs, was assessed according to the NCI-CTCAE version 3.0; if the AE was not specifically listed, the following grades of severity were used: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening or disabling; and Grade 5 is death. Multiple occurrences of the same AE in 1 participant were counted multiple times. Only AEs that started during the overall study treatment period were included. The cutoff date for inclusion of events and for calculation of patient-years was the date of the most recent follow-up of the participant, defined as the last available date during the treatment period, excluding pre-treatment and safety follow-up data. Confidence intervals were calculated assuming the number of events followed a Poisson distribution. Data reported prior to the date of first crossover treatment were included under the Placebo arm for participants who crossed over from placebo to pertuzumab.|From Baseline to 42 days after the last dose of study treatment (total patient-years of exposure on study treatment in Placebo vs. Pertuzumab arms: 526.81 vs. 989.88 patient-years)|Safety Population: All participants who received at least one dose of any study medication.|||Events per 100 patient-years|Adverse Events|90% Confidence Interval|Number
2793456|NCT00567008|Primary|Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.|Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.|8 weeks||||participants|||Number
2793417|NCT00567190|Secondary|Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events, by Most Severe Intensity (According to NCI-CTCAE v3.0) During the Treatment Period|Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of the same AE in one participant. AEs reported prior to first crossover treatment were included in the Placebo arm, and in the Crossover arm after that date, for participants who crossed over from placebo to pertuzumab. Median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks; Crossover: 129.9 [0.3-322.3] weeks.|Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)|Safety Population: All participants who received at least one dose of any study medication.|||Participants|||Count of Participants
2793418|NCT00567190|Secondary|Time to Symptom Progression|"Time to symptom progression was defined as the time from randomization to the first symptom progression as measured by the Functional Assessment of Cancer Therapy-for patients with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contains 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer patients (breast cancer subscale [BCS]). All items in the questionnaire were rated by the patient on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96. A higher score indicates better perceived quality of life. A positive change score from baseline indicates improvement. Symptom progression was defined as a decrease from baseline of 5 points or more."|Every 9 weeks from Baseline until investigator-determined progressive disease, up to the primary completion date (up to 3 years, 3 months)|ITT population: All randomized participants; only female participants were included in the analysis.|||Weeks||95% Confidence Interval|Median
2793419|NCT00567190|Secondary|Duration of Objective Response Determined by an Independent Review Facility|Duration of objective response (estimated using the Kaplan-Meier method) was defined as the time from the initial confirmed complete response (CR) or partial response (PR), the date of tumor assessment at which the CR/PR was first detected by the independent review facility (IRF) using RECIST version 1.0, until the date of IRF-determined progressive disease (PD), death from any cause within 18 weeks of the last tumor assessment, or first administration of next line of anti-cancer therapy (whichever occurred first). If the visit when the initial CR or PR was observed spanned multiple dates, the latest date was used. Only participants in the ITT analysis population with an IRF-determined objective response (CR or PR), observed prior to IRF-assessed PD, death or next line of anti-cancer therapy, were included in the analysis. Participants who did not progress or die after they had a confirmed response were censored at the date of their last IRF-evaluable tumor measurement.|From initial IRF-confirmed objective response until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)|ITT Population: All randomized participants; only participants with IRF-determined measurable disease at baseline (i.e., ≥1 target lesion) that had an objective response were included in the analysis.|||Weeks||95% Confidence Interval|Median
2793420|NCT00567190|Secondary|Objective Response Determined by an Independent Review Facility|An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by an independent review facility (IRF) using RECIST v1.0 on two consecutive occasions ≥4 weeks apart. For target lesions, CR: disappearance of all target lesions; PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions (baseline sum LD as reference); PD: ≥20% increase in the sum of the LD of target lesions (smallest sum of the LD recorded as reference) or appearance of ≥1 new lesion; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for PD. For non-target lesions, CR: disappearance of all non-target lesions; Incomplete/SD: persistence of ≥1 non-target lesions; PD: unequivocal progression of existing non-target lesions. 95% confidence intervals (CI) were calculated only for clinical responses using the Pearson-Clopper method.|Tumor assessments every 9 weeks from Baseline until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)|ITT Population: All randomized participants; only participants with IRF-determined measurable disease at baseline (i.e., ≥1 target lesion) were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2793421|NCT00567190|Secondary|Progression-Free Survival (PFS) Determined by the Investigator|PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by the investigator using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of ≥1 new lesion. For non-target lesions, PD was defined as the appearance of ≥1 new lesion or unequivocal progression of existing lesions. Participants without PD or who had not died within 18 weeks of their last investigator-determined, progression-free tumor assessment were censored at the date of the last investigator tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.|Tumor assessments every 9 weeks from randomization to investigator-determined PD or death from any cause, whichever occurred first (median [range] time on study in pertuzumab vs. placebo arms: 201.8 [0.7-520.0] weeks vs. 138.0 [0.4-514.7] weeks)|Intent-to-treat population: All randomized patients.|||Months||95% Confidence Interval|Median
2793514|NCT00566696|Secondary|To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.|The Cumulative Incidence of Relapse will be reported as the proportion of number of relapses since transplant to the total number of patients at risk at five years post-transplant.|five years post-transplant||||Percentage of participants|||Number
2793422|NCT00567190|Secondary|Overall Survival|Overall survival (OS) was the time from randomization to death from any cause, using Kaplan-Meier methodology. Survival data was collected every 18 weeks during the post-treatment follow-up period until death, loss to follow-up, or withdrawal of consent. Those who were alive, lost to follow up, or withdrew consent were censored at the latest date they participated in the study; those without post-baseline data were censored at 1 day. OS analyses were planned to take place at the primary completion date (First Interim), after 385 deaths (Event-Driven Final), and at the end of study (End-of-Study). A second interim OS analysis was planned due to a formal request from the European Medicines Agency. Median [range] time in weeks on study at each OS analysis (Pertuzumab vs. Placebo): First: 77.1 [0.7-165.3] vs. 73.1 [0.4-165.3]; Second: 117.1 [0.7-207.9] vs. 105.9 [0.4-207.9]; Event-Driven Final: 189.9 [0.7-304.1] vs. 140.5 [0.4-301.6]; End-of-Study: 201.8 [0.7-520.0] vs. 138.0 [0.4-514.7].|From randomization to death from any cause, up to each respective analysis data cut-off date (see the Description field for the median time on study per treatment arm)|ITT Population: All randomized participants|||Months||95% Confidence Interval|Median
2793423|NCT00567190|Primary|Progression-Free Survival (PFS) Determined by an Independent Review Facility|PFS was defined as the time from randomization to first documented radiographical progressive disease (PD), as determined by an independent review facility (IRF) using RECIST version 1.0, or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first (Kaplan-Meier method). For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of ≥1 new lesion. For non-target lesions, PD was defined as the appearance of ≥1 new lesion or unequivocal progression of existing lesions. Participants without IRF-determined PD or who had not died within 18 weeks of their last IRF-determined, progression-free tumor assessment were censored at the date of the last IRF-reviewed, evaluable tumor assessment; those with no post-baseline tumor assessment and who had not died within 18 weeks of baseline were censored at 1 day.|Tumor assessments every 9 weeks from randomization to IRF-determined PD or death from any cause, whichever occurred first, up to the primary completion date (up to 3 years, 3 months)|Intent-to-Treat (ITT) Population: All randomized participants|||Months||95% Confidence Interval|Median
2793424|NCT00567164|Secondary|Length of Cycles|Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.|Up to 1 year|Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included.|||Days|Participants|Standard Deviation|Mean
2793425|NCT00567164|Secondary|Number of Scheduled and Unscheduled Bleeding Days|Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens.|||Days||Standard Deviation|Mean
2793426|NCT00567164|Secondary|Number of Intracyclic Bleeding Days|Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding.|||Days||Standard Deviation|Mean
2793427|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14.|||Percentage of Participants|||Number
2793428|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13.|||Percentage of Participants|||Number
2793429|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12.|||Percentage of Participants|||Number
2793431|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10.|||Percentage of Participants|||Number
2793432|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9.|||Percentage of Participants|||Number
2793433|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8.|||Percentage of Participants|||Number
2793434|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7.|||Percentage of Participants|||Number
2793435|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6.|||Percentage of Participants|||Number
2793436|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5.|||Percentage of Participants|||Number
2793437|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4.|||Percentage of Participants|||Number
2793438|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3.|||Percentage of Participants|||Number
2793495|NCT00566722|Secondary|Percent Activity Impairment Due to Psoriasis|Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was using for missing data. Screening data were not available for all participants.|||Change in percent activity impairment||Standard Deviation|Mean
2793439|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2.|||Percentage of Participants|||Number
2793440|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1.|||Percentage of Participants|||Number
2793441|NCT00567164|Secondary|Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.|Day 271 to Day 360|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4.|||Days||Standard Deviation|Mean
2793442|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.|Day 181 to Day 270|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3.|||Days||Standard Deviation|Mean
2793443|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.|Day 91 to Day 180|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2.|||Days||Standard Deviation|Mean
2793444|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.|Day 1 to Day 90|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1.|||Days||Standard Deviation|Mean
2793445|NCT00567164|Secondary|Number of Bleeding Days (Excluding Spotting Days)|Number of days per participant with bleeding (excluding spotting days)|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.|||Days||Standard Deviation|Mean
2793446|NCT00567164|Secondary|Number of Bleeding Days (Including Spotting Days)|Number of days per participant with bleeding or spotting|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.|||Days||Standard Deviation|Mean
2793447|NCT00567164|Primary|Pearl Index|The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.|Up to 1 year|Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms.|||Pregnancies per 100 years of exposure||95% Confidence Interval|Mean
2793448|NCT00567112|Secondary|t1/2 for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements|||hours||Full Range|Median
2793449|NCT00567112|Secondary|Tmax for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements|||hours||Full Range|Median
2793450|NCT00567112|Primary|Half Life (t½) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements|||hours||Full Range|Median
2793451|NCT00567112|Primary|Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements|||hours||Full Range|Median
2793452|NCT00567112|Secondary|Cmax of OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements|||nM||Full Range|Least Squares Mean
2793453|NCT00567112|Secondary|AUC(0-∞) for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements|||nM*hr||Full Range|Least Squares Mean
2793457|NCT00566995|Other Pre-specified|Change in Plasma Biomarkers Vascular Endothelial Growth Factor (VEGF) and Soluble Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Before and After Treatment With Vandetanib|5-10cc venous blood was collected for evaluation of basal plasma levels of angiogenesis biomarkers VEGF and VEGFR-2.|Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)|This analysis was intended to be exploratory. Several other studies established that therapy with VEGFR agents modulated serum/plasma VEGF and soluble VEGFR2 levels, but there was no consistent & established correlation with clinical outcome. These analyses were unlikely to add further to our ability to evaluate the major objectives of the study.||||||
2793458|NCT00566995|Secondary|Response in Pheochromocytomas Associated With Von Hippel Lindau (VHL)|Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.|This outcome measure was not done because no participants had measurable lesions.||||||
2793459|NCT00566995|Secondary|Response in Central Nervous System (CNS) Hemangioblastomas Associated With Von Hippel Lindau (VHL)|Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.|Only two participants had target lesions that could be measured.|||Participants|||Count of Participants
2793460|NCT00566995|Secondary|Response in Pancreatic Tumors/Cysts Associated With Von Hippel Lindau (VHL)|Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Tumor measurements for non-renal tumors were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest um LD recorded since treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.|Only two participants had target lesions that could be measured.|||Participants|||Count of Participants
2793461|NCT00566995|Secondary|Effect of Vandetanib (ZD6474) on Circulating Endothelial Cells (CEC)|Peripheral blood was collected and analyzed by multiparametric flow cytometry.|Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)|No samples were received for 2/37 participants.|||CEC per 10^6 mononuclear cells||Full Range|Median
2793462|NCT00566995|Secondary|Effect of Vandetanib (ZD6474) on Endothelial Progenitor Cells|Peripheral blood was collected and analyzed by multiparametric flow cytometry for analysis of angiogenesis markers.|Pre treatment, 4 hours after first treatment, and after one cycle of treatment (one cycle = 28 days)|No samples were received for 2/37 patients.|||Cells per 10^6 mononuclear cells||Full Range|Median
2793463|NCT00566995|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as time from initiation of treatment to either progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.||||Months||95% Confidence Interval|Median
2793464|NCT00566995|Secondary|Time To Progression (TTP)|Time to progression is defined as the time from the start of treatment to progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, with death being treated as a censored event. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new lesions, developing a surgical size tumor that should be resected. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles while on study, up to 2 years.||||Months||95% Confidence Interval|Median
2793465|NCT00566995|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|72 months and 14 days||||Participants|||Count of Participants
2793515|NCT00566696|Secondary|Incidence of Regimen-related Mortality|The incidence of regimen-related mortality in the first 100 days post-transplant is estimated based on binomial distribution.|100 days post-transplant||||Percentage of participants|||Number
2794142|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793466|NCT00566995|Primary|Overall Response Rate.|Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|Baseline and every 3 cycles, up to 2 years||||percentage of participants|||Number
2793467|NCT00566982|Secondary|Visual Evaluation of the Vagina (Baseline & Week 52)||52 weeks|ITT|||participants|||Number
2793468|NCT00566982|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||52 weeks|ITT|||nmol/L||Standard Deviation|Mean
2793469|NCT00566982|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||52 weeks|ITT|||U/L||Standard Deviation|Mean
2793470|NCT00566982|Secondary|Change From Baseline in Luteinizing Hormone Levels||52 weeks|ITT|||U/L||Standard Deviation|Mean
2793471|NCT00566982|Secondary|Change From Baseline in Estradiol Levels||52 weeks|ITT|||nmol/L||Standard Deviation|Mean
2793472|NCT00566982|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT|||pH||Standard Deviation|Mean
2793473|NCT00566982|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear||12 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
2793474|NCT00566982|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||12 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
2793475|NCT00566969|Primary|Percent Days Abstinent From Cocaine - Self Report|Percent Self reported days of abstinence from any cocaine use during the 11 week trial.|11 weeks||||percentage of days||Standard Deviation|Mean
2793476|NCT00566943|Secondary|Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.|Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.|Discharge, 30 and 90 days||||participants|||Number
2793477|NCT00566943|Secondary|Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group|Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.|Discharge and 30 days||||Participants|||Number
2793478|NCT00566943|Primary|Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.|Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.|Discharge/30 Linear Discharge/30/90 days Circular||||Participants|||Number
2793479|NCT00566943|Primary|Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.|Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.|Discharge/ 30 days Linear Discharge/30/90 days Circular||||Participants|||Number
2793480|NCT00566930|Primary|Neck Pain|Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)|Up to 10 months||||cm||Standard Deviation|Mean
2793481|NCT00566930|Secondary|Fear Avoidance Belief, Quality of Life, Range of Motion||One year|||||||
2793482|NCT00566852|Secondary|Overall Survival|Failure for overall survival is death from any cause. Median survival was estimated using the Kaplan-Meier method.|From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.|All eligible patients|||months||95% Confidence Interval|Median
2793483|NCT00566852|Secondary|Median Progression-free Survival Time|Disease progression is defined as the first of the following events: an increase of at least 50% for lesions less than or equal to 1cm, an increase of least 25% for lesions greater than 1cm, appearance of any new brain metastases. Failure for progression-free survival is disease progression or death. Median progression-free survival was estimated using the Kaplan-Meier method.|From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.|All eligible patients|||months||Inter-Quartile Range|Mean
2793484|NCT00566852|Secondary|Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks|The FACT-Br is a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), functional well-being (7 questions) and brain cancer subscale which contains concerns relevant to patients with brain tumors (23 questions). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total is obtained by adding all domains together if the overall question response rate is greater than 80%. Total scores on the FACT-Br range from 0 to 184 with lower scores indicating declining quality of life. Change is calculated as baseline score subtracted from 24-week score.|Baseline and 24 weeks from start of treatment|Eligible patients with FACT-Br score at baseline and 24 weeks.|||units on a scale||Inter-Quartile Range|Median
2793496|NCT00566722|Secondary|Percent Impairment While Working Due to Psoriasis|Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.|||Change in % impairment while working||Standard Deviation|Mean
2793485|NCT00566852|Secondary|Median Time to Neurocognitive Failure|Neurocognitive failure is defined as the first cognitive failure on any of the neurocognitive tests: the HVLT-R for immediate recall, delayed recognition, and delayed recall; the Controlled Oral Word Association Test (COWAT); the Trail-Making Test (TMT) Parts A and B. Cognitive failure for each test is defined as a post-treatment score that meets one of the following criteria: follow-up score is at least 2 standard deviations worse than the patient's personal baseline score or the patient's raw score change is greater than the reliable change index. The cumulative incidence approach was used to estimate the median time to neurocognitive failure to account for the competing risks of disease progression and death.|Baseline to 12 months from the start of drug treatment|All randomized eligible patients with neurocognitive scores from baseline to 12 months from start of drug treatment.|||years||95% Confidence Interval|Median
2793486|NCT00566852|Secondary|Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks|The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.|Baseline, 8, 16, and 52 weeks from the start of drug treatment|Eligible patients with baseline and respective post-baseline measurements|||units on a scale||Inter-Quartile Range|Median
2793487|NCT00566852|Primary|Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks|The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from 24-week value. Imputation methods were used to determine values for all alive patients missing the 24 week assessment. This tool is being used to measure cognitive function, specifically memory.|Baseline and 24 weeks from the start of drug treatment|All eligible patients with Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R delayed recall) at baseline and 24 weeks.|||units on a scale||Inter-Quartile Range|Median
2793488|NCT00566813|Primary|Number of Participants With HbA1c Less Than or Equal to 6.5 & Free of Severe Hypoglycemic Events|HbA1c less than or equal to 6.5 at end of 15 month study participation, and lack of or free from severe hypoglycemic events, defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person and which was associated with either a blood glucose level < 50 mg/dl (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.|At end of 15 month study participation||||participants|||Number
2793489|NCT00566813|Primary|Number of Participants With Insulin Independence at End of Study Participation|Primary efficacy outcome: independence from insulin injections with adequate control of blood glucose in subjects with Type 1 diabetes. Transplant is considered a success when 2 weeks after their last transplant, subjects are not using insulin, and fasting glucose levels do not exceed 7.8 mmol/L (140 mg/dL) more than 3 times/week, and two-hour post-prandial glucose values do not exceed 10 mmol/L (180 mg/dL) more than 4 times/week. During the 15 months after last transplant, a subject will be considered a success if an illness or other event (e.g., high tacrolimus level) causes need for insulin not exceeding 14 days providing evidence of graft rejection is not apparent. The proportion of subjects who are insulin independent and meet criteria for glucose control will be determined at 2 weeks and 1, 3, 6, 12, and 15 months following their final islet transplant.|End of 15 Month Study Participation/Follow-up||||participants|||Number
2793490|NCT00566813|Primary|Number of Participants With Adverse Events Including Laboratory Abnormalities at the End of Study Participation|"Frequency of adverse events including laboratory abnormalities~HbA1C (less than 6.1% is considered normal)~Glucose control and absence of hypoglycemic coma/unawareness, as evidenced by no further requirement for third-party assistance or hospital attendance resulting from a severe hypoglycemic episode~Renal function, measured both by serum creatinine and calculated GFR using the Cockroft & Gault~Lipid profiles for cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL)~PRA~Doppler ultrasound to exclude or document portal vein thrombosis~Immunosuppressive drug trough levels~Renal clearance (GFR)~Liver function tests~Diagnosis of opportunistic infections, e.g., CMV"|15 months after the last transplant|The number of participants analyzed represents the number of subjects in Group 1 (Islet Cells) and Group 2 (Islet Cells + Etanercept + Exenatide)|||participants|||Number
2793491|NCT00566735|Secondary|Baseline Depressive Symptoms|This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression.|Participants were questioned at baseline||||Score on the HAM-D-17||Standard Deviation|Mean
2793492|NCT00566735|Secondary|Cognitive Functioning|This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.|Participants were questioned at baseline and after their last electroconvulsive therapy treatment||||Score on the DMI||Standard Deviation|Mean
2793493|NCT00566735|Primary|Number of Side Effects|This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.|Participants were followed for the duration of hospital stay, an average of 3 weeks||||Number of reported side effects|||Number
2793494|NCT00566722|Secondary|Sleep Problems Index II|"Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from none of the time to all of the time for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement."|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants for all items; as a result, not all participants were included in the analysis.|||Change in scores on a scale||Standard Deviation|Mean
2793497|NCT00566722|Secondary|Percent Overall Work Impairment Due to Psoriasis|Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.|||Change in % overall work impairment||Standard Deviation|Mean
2793498|NCT00566722|Secondary|Percent Work Time Missed Due to Psoriasis|Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab are included. Last observation carried forward was used for missing data. Screening data were not available for all participants.|||Change in percent time missed||Standard Deviation|Mean
2793499|NCT00566722|Secondary|Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis|The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.|||Change in scores on a scale||Standard Deviation|Mean
2793500|NCT00566722|Secondary|Psoriasis-related Pruritus Assessment|The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data.|||Change in scores on a scale||Standard Deviation|Mean
2793501|NCT00566722|Secondary|Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16|DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.|Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (score of 0 not achieved) was used for missing data.|||Participants|||Number
2793502|NCT00566722|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.|From Screening to Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.|||Change in scores on a scale||Standard Deviation|Mean
2793503|NCT00566722|Secondary|Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8|The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.|Weeks 2, 4, and 8|All participants who received at least 1 dose of adalimumab are included. Nonresponder imputation was used for missing data; that is, participants who did not have an evaluation at the time point were assumed to not have achieved a 0 or 1 on the PGA.|||Participants|||Number
2793504|NCT00566722|Secondary|Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening||From Screening to Week 16|All participants who were enrolled and received a dose of adalimumab were included. Non-responder imputation (1 grade of improvement not achieved) was used for missing data.|||Participants|||Number
2793505|NCT00566722|Secondary|Number of Participants Achieving a PGA of Clear (0) at Week 16||Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear [0] not achieved) was used for missing data.|||Participants|||Number
2793506|NCT00566722|Primary|Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16|The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).|Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear or minimal not achieved) was used for missing data.|||Participants|||Number
2793507|NCT00566709|Secondary|Unfavorable Glasgow Outcome Scale (GOS)|"GOS measures the degree of disability associated with the brain injury~Unfavorable GOS included the categories of:~death.~vegetative status.~severe disability."|At hospital discharge, an average of 21 days||||participants|||Number
2793508|NCT00566709|Secondary|Long-term Mortality||1-year after hospital discharge||||participants|||Number
2793509|NCT00566709|Secondary|Length of Intensive Care Unit (ICU) Stay||The length of ICU stay, an avarege of 17 days||||days||Standard Deviation|Mean
2793510|NCT00566709|Secondary|Hospital Mortality||length of the hospital stay, an average of 20 days||||participants|||Number
2793511|NCT00566709|Primary|Percentage of Transfused Patients in Each Group||duration of the protocol, an average of 15 days||||percentage of transfused participant|||Number
2793512|NCT00566709|Primary|Number of Units of Packed Red Blood Cell Transfused|Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol|duration of the protocol, an average of 15 days||||units||Standard Deviation|Mean
2793513|NCT00566696|Secondary|To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.|The rate of Overall Grade III-IV Acute AVHD will be report as the proportion of patients who have Grade III-IV Acute GVHD to the total patients with transplant. The rate of Chronic GVHD will be report as the proportion of patients who have Chronic GVHD to the total patients with transplant. The Severity of Chronic GVHD will be reported using CTCAE grading system, as a number.|five years post-transplant||||Percentage of participants|||Number
2793516|NCT00566696|Secondary|Incidence of Non-hematologic Regimen-related Toxicities|Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death.|100 days post-transplant||||percentage of participants|||Number
2793517|NCT00566696|Secondary|Disease-Free Survival (DFS)|Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|One year post-transplant||||Percentage of participants|||Number
2793518|NCT00566696|Secondary|Overall Survival (OS)|Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant||||Percentage of participants|||Number
2793519|NCT00566696|Primary|Event-free Survival (EFS)|To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant||||Percentage of participants|||Number
2793520|NCT00566631|Other Pre-specified|Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The BARS included an objective rating (from 0=normal to 3=constantly engaged), two subjective ratings of symptoms of akathisia, namely awareness of restlessness (ranging from 0=absence of inner restlessness to 3=awareness of intense compulsion to move) and reported distress related to restlessness (ranging from 0=no distress to 3=severe), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). Global rating sub-scale score (that is, global clinical rating of akathisia) was assessed which was scored separately and is the most relevant measure of severity of akathisia. Higher scores indicates worsening akathisia. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793521|NCT00566631|Other Pre-specified|Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The SAS rates 10 items (including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, Glabella tap, tremor and salivation), score ranging from 0 (normal) to 4 (extreme). The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score indicates more severe condition of Extrapyramidal Symptoms. Final evaluation is the last post- baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793522|NCT00566631|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none and 4=severe). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793523|NCT00566631|Secondary|Number of Participants Satisfied With the Study Treatment|Treatment satisfaction with paliperidone ER was assessed by the Investigator and participant on a 5-point scale: 1 (very good), 2 (good), 3 (reasonable), 4 (moderate) and 5 (poor), at the end of the core treatment phase (which is, Day 42 or early discontinuation) by conducting an interview.|Day 42 or early discontinuation|The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure at given time point.|||Participants|||Number
2793524|NCT00566631|Secondary|Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The day time drowsiness evaluation scale is a self-administered scale that rates day time drowsiness. Participants indicate on an 11-point scale that how often they have felt drowsy within the previous 7 days, score ranged from 0 (not at all) to 10 (all the time). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793525|NCT00566631|Secondary|Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The sleep evaluation scale is a self-administered scale that rates quality of sleep. Participants indicate on an 11-point scale that how well they have slept within the previous 7 days, score ranged from 0 (very badly) to 10 (very well). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793526|NCT00566631|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PSP assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal & social relationships, self-care & disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a Scale||Standard Deviation|Mean
2793527|NCT00566631|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data."|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793528|NCT00566631|Secondary|Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.|||Percentage of participants|||Number
2793529|NCT00566631|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms and disorganized thoughts subscale, consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement (H/E) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity. Final evaluation is the last post-baseline visit with data.|Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2793530|NCT00566631|Secondary|Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “n signifies those participants who were evaluated for this measure at given time points."|||Units on a scale||Standard Deviation|Mean
2793531|NCT00566631|Primary|Number of Participants With Treatment Response Based on Total PANSS Scale Score|Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, & poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of sum of all 30 PANSS items & ranges from 30 to 210. Higher scores indicate worsening.|Day 42 or early discontinuation|Intent-to-treat (ITT) population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.|||Participants|||Number
2793532|NCT00566579|Primary|Number of Patients With Human Papillomavirus Clearance|At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.|12 months||||participants|||Number
2794143|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793533|NCT00566527|Secondary|Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2|The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.|Day 132 (6 weeks after ProQuad® Dose 2)|All participants who received ProQuad® Dose 2 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
2793534|NCT00566527|Secondary|Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1|The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.|Up to Day 28 (up to 4 weeks after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
2793535|NCT00566527|Secondary|Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1|The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Day 42 (6 weeks after ProQuad® Dose 1)|All baseline seronegative participants with immunogenicity data are included.|||Percentage of participants||95% Confidence Interval|Number
2793536|NCT00566527|Secondary|Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL|The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined.|Day 132 (6 weeks after ProQuad® Dose 2)|All participants who received ProQuad® and have serology results are included.|||Percentage of participants||95% Confidence Interval|Number
2793537|NCT00566527|Secondary|GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2|Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.|Day 132 (6 weeks after ProQuad® Dose 2)|All participants with seronegative baselines who received ProQuad® Dose 2 and have immunogenicity data available are included.|||GMT||95% Confidence Interval|Geometric Mean
2793538|NCT00566527|Secondary|Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1|Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.|Day 42 (6 weeks after ProQuad® Dose 1)|All participants with seronegative baselines who received ProQuad® Dose 1 and have immunogenicity data available are included.|||GMT||95% Confidence Interval|Geometric Mean
2793539|NCT00566527|Primary|Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C|The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.|Up to Day 28 (up to 28 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
2793540|NCT00566527|Primary|Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1|The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.|Up to Day 28 (up to 28 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
2793541|NCT00566527|Primary|Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions|The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.|Up to Day 28 (up to 28 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
2793542|NCT00566527|Primary|Percentage of Participants With Solicited Injection-site Adverse Reactions|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.|Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)|All participants who received ProQuad® Dose 1 and have safety follow-up data available are included.|||Percentage of participants||95% Confidence Interval|Number
2793543|NCT00566527|Primary|Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2|Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Day 132 (6 weeks after ProQuad® Dose 2)|All baseline seronegative participants with immunogenicity data are included.|||Percentage of participants||95% Confidence Interval|Number
2793572|NCT00566098|Secondary|Survival|Survival in months for participants who are alive (Overall Survival) and alive without disease progression (Progression-free survival). Disease progression is defined as a change from negative to positive on immunofixation or electrophoresis for participants previously in complete remission or a 25% increase in serum electrophoresis for participants not previously in complete remission. Partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 129 months||||months||Full Range|Median
2793544|NCT00566527|Primary|Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2|Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Day 132 (6 weeks after ProQuad® Dose 2)|All baseline seronegative participants with immunogenicity data are included.|||Percentage of participants||95% Confidence Interval|Number
2793545|NCT00566501|Secondary|Mean Change From Baseline in SIB Score|The Severe Impairment Battery (SIB) evaluates the severity of cognitive dysfunction in patients with more advanced dementia.|12 months|||||||
2793546|NCT00566501|Secondary|Mean Change From Baseline in MMSE Score|The Mini-Mental State Examination (MMSE) is a brief, 30-item test of cognitive function.|12 months|||||||
2793547|NCT00566501|Primary|Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period|Adverse events (AEs), including SAEs, were recorded from the time of consent. Recording of AEs ceased after the Final Visit or Early Termination Visit, except that SAEs were monitored for 30 days after study drug discontinuation.|Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs)|The Safety Population consisted of all subjects who received at least one dose of donepezil SR 23 mg during Study 328. Two groups were categorized: those who received donepezil 10 mg IR and those who received donepezil 23 mg SR during Study 326.|||participants|||Number
2793548|NCT00566462|Secondary|Change in Caudate and Putamen [^123I]-IBZM Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|No data was collected because the study was terminated at the sponsor request due to low enrollment.||||||
2793549|NCT00566462|Primary|Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|No data was collected because the study was terminated at the sponsor request due to low enrollment.||||||
2793550|NCT00566254|Secondary|Percent of Participants With =25% and =100% Increase From Baseline in 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population|||Percentage of Participants|||Number
2793551|NCT00566254|Secondary|Percent of Participants With =50% to < 75% and = 75% Decrease From Baseline in 28-day Seizure Frequency During the Maintenance Period(LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population|||Percentage of Participants|||Number
2793552|NCT00566254|Secondary|Median Percent Change From Baseline in the 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number,and type of seizures the subject had. Seizure frequency of simple partial,complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population|||Percentage Change in Seizure Frequency||Full Range|Median
2793553|NCT00566254|Primary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF)|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. The primary analysis assessed the percent of responders in the Maintenance Period (28- day seizure frequency in Week 8 to Week 20 compared to Week -8 to Week 0 at Last Observation Carried Forward (LOCF)). Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0), and Week 8 to Week 20|The Intent to Treat (ITT)Population was defined as the group of randomized subjects who received at least one does of doubleblind study medication|||Percentage of Participants|||Number
2793554|NCT00566228|Other Pre-specified|Evaluation and Comparison of Immunologic Recovery Within and Between the Arms by Assessing the Quantitative and Functional Immune Effector Cells (T, B, or NK Cells) From the Apheresis Product|Evaluation and comparison of immunologic recovery within and between the arms by assessing the quantitative and functional immune effector cells (T, B, or NK cells) from the apheresis product|Baseline|||||||
2793555|NCT00566228|Secondary|Median Number of CD34 Cells/kg Infused|Five (5) to seven (7) days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater, stem cell collection began. Apheresis collections were to be performed daily. At least 2 x 10^6 CD34 cells/kg were to be collected. Additional collections were at the discretion of the transplantation team. The median number of CD34 cells/kg infused are reported for each arm below.|5 to 7 days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater||||x10^6 cells/kg||Full Range|Median
2793556|NCT00566228|Secondary|Median Time to Absolute Lymphocyte Count Engraftment|The time to absolute lymphocyte count (ALC) engraftment will be evaluated and compared between the two arms, where time to ALC engraftment is defined as the time from transplant to the time they achieve ALC > 500.|Up to 30 days after autologous peripheral hematopoietic stem cell transplantation||||days||Full Range|Median
2793557|NCT00566228|Secondary|One-year Overall Survival Rate|Overall survival (OS) was defined at the time from infusion to death from any cause. The one-year OS rate is defined as the percentage of patients who are still alive after one year. A log rank test was used to assess whether OS differed with respect to apheresis collection method.|date of infusion to death from any cause, up to one year||||percentage of patients||95% Confidence Interval|Number
2793558|NCT00566228|Secondary|Progression-free Survival Rate at 2 Years|Progression-free survival rate (percentage) at two years is defined as 100 times the number of patients who have not progressed, relapsed and/or died divided by the total number of evaluable patients in each arm. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the SPD of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm).|Date of infusion to disease progression, relapse, or death from any cause, up to two years||||percentage of patients||95% Confidence Interval|Number
2793559|NCT00566228|Secondary|Progression-free Survival Rate at 1 Year|Progression-free survival rate (percentage) at one year is defined as 100 times the number of patients who have not progressed, relapsed and/or died divided by the total number of evaluable patients in each arm. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the SPD of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm).|Date of infusion to disease progression, relapse, or death from any cause, up to one year||||percentage of patients||95% Confidence Interval|Number
2793560|NCT00566228|Primary|Median Progression-free Survival|Progression free survival (PFS) was defined as the time from the date of infusion to disease progression, relapse, or death from any cause. Patients alive without disease progression or relapse were censored at their last disease evaluation or at their secondary primary cancer diagnosis, whichever occurred first. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the sum of the products of diameters (SPD) of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm). A log rank test was used to assess whether PFS differed with respect to apheresis collection method.|Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment.||||months||95% Confidence Interval|Median
2793561|NCT00566150|Secondary|Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.|Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.|||score on scale||Standard Error|Least Squares Mean
2793562|NCT00566150|Secondary|Number of Subjects Who Achieve Remission.|"Remission response is measured as an HDRS-21 total score is less than or equal to 7.~HDRS-21 measures range of depressive symptoms. Endpoint is LOCF."|Week 6||||Participants|||Number
2793563|NCT00566150|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.|||score on scale||Standard Error|Least Squares Mean
2793564|NCT00566150|Primary|Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.|||score on scale||Standard Error|Least Squares Mean
2793565|NCT00566111|Secondary|Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).|The number of patients that had a decrease on CGI-BP at 4 weeks.|4 weeks|only patients with complete data at 4 weeks were analyzed|||participants|||Number
2793566|NCT00566111|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.|The number of patients that had a decrease on MADRS at 4 weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed|||participants|||Number
2793567|NCT00566111|Secondary|Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.||4 weeks|only participants with complete data at 4 weeks were analyzed|||participants|||Number
2793568|NCT00566111|Secondary|Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|These data were not collected.||||||
2793569|NCT00566111|Primary|Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed|||participants|||Number
2793570|NCT00566098|Secondary|Anti-tumor Immune Responses|Myeloma lysate response that measures the T-cell response quantified as %CD3+/CFSE-low/IFN-gamma+.|At time of bone marrow harvest, Day 60 post-transplant, Day 180 post-transplant, and Day 360 post-transplant||||%CD3+/CFSE-low/IFN-gamma+||Full Range|Mean
2793571|NCT00566098|Secondary|Pneumococcal-specific Vaccine Responses|CRM-197 Prevnar-specific vaccine responses that measure the T-cell response of the vaccine quantified as %CD3+/CFSE-low/IFN-gamma+.|At time of bone marrow harvest, Day 60 post-transplant, Day 180 post-transplant, and Day 360 post-transplant||||%CD3+/CFSE-low/IFN-gamma+||Full Range|Mean
2793573|NCT00566098|Secondary|T-cell Reconstitution as Determined by Absolute Lymphocyte Count (ALC)|ALC counts trending over time.|Days 14, 28, 60, 180, and 360|Data was not collected on one participant at the Day 28 and 180 timepoints, and data was not collected for eight participants at the Day 360 timepoint. Data was not collected on CD3+/CD4+/CD8+ cells for all participants.|||cells per microliter||Full Range|Median
2793575|NCT00566098|Primary|Disease Response|Percentage of participants with partial or complete response by Bladé criteria. Partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 2 years||||Participants|||Count of Participants
2793576|NCT00566098|Primary|Hematopoietic Engraftment|Days to absolute neutrophil count > 500 cells per microliter.|Up to 1 year||||days||Full Range|Median
2793577|NCT00566020|Secondary|Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants without concomitant use of inhibitor and inducer from the date of the first dose of study medication to the date of the last dose. Multiple blood samplings were conducted for some participants. A total of 82 participants were analyzed; 4 participants did not have 200 mg dose data but had data for lower doses.|||Nanograms per milliliter||Full Range|Median
2793578|NCT00566020|Secondary|Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants (par.) who took at least one dose of drugs that inhibit lamotrigine glucuronidation (i.e., valproate) from the date of the first dose of study medication to the date of the last dose. A total of 8 par. were analyzed; 1 par. had both 100 and 200 mg data, 4 par. had 100 mg data only, and 3 par. had 200 mg data only.|||Nanograms per milliliter||Full Range|Median
2793579|NCT00566020|Secondary|Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)|Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants who took at least one dose of drugs that induce lamotrigine glucuronidation (e.g., carbamazepine) from the date of the first dose of study medication to the date of the last dose.|||Nanograms per milliliter||Full Range|Median
2793580|NCT00566020|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
2793581|NCT00566020|Secondary|Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|"The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the best rating and 4 or 8 is the worst rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst)."|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
2793582|NCT00566020|Secondary|Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
2793583|NCT00566020|Secondary|Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
2793666|NCT00565747|Secondary|Number of Top Quality Embryos (TQE´s)|Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes.|3 days from oocyte pick-up|PP-population|||percentage of 2PN's|||Number
2793584|NCT00566020|Secondary|Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||scores on a scale||Standard Deviation|Mean
2793585|NCT00566020|Secondary|Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Full Analysis Set (FAS): participants who received >=1 dose of study medication and underwent >=1 efficacy assessment. Observed Cases (OC; observed data with no imputation) and Last Observation Carried Forward (LOCF; data imputed [replaced] by most recent observed value [compared to planned date of missing observation]) were used for analysis.|||scores on a scale||Standard Deviation|Mean
2793586|NCT00566020|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW|ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.|Weeks 0, 6, 28, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793587|NCT00566020|Primary|Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||Kilograms per meters squared||Standard Deviation|Mean
2793588|NCT00566020|Primary|Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The weight of participants was recorded at the indicated time points.|Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||kilograms||Standard Deviation|Mean
2793589|NCT00566020|Primary|Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Heart rate was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||beat per minute||Standard Deviation|Mean
2793590|NCT00566020|Primary|Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Systolic and diastolic blood pressure was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||Millimeters of mercury||Standard Deviation|Mean
2793591|NCT00566020|Primary|Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG [-]), trace (TRA [+/-]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793592|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Red blood cell count was measured in participants at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10^12)/L, Female: 3.76-5.16 TI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793593|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793594|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793595|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter [MMOL/L]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793596|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793597|NCT00566020|Primary|Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|||participants|||Number
2793598|NCT00566020|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)|Safety Population: all participants who received at least one dose of study medication|||participants|||Number
2793599|NCT00565916|Primary|Number of Participants That Had an Increase in Myocardial Fatty Acid Utilization.|Measurements of myocardial fatty acid utilization and oxidation with C[11]-Palmitate and PET in healthy postmenopausal women who take either estrogen alone or with progesterone. The primary outcome measure was designed to determine prospectively whether estrogen will increase the heart's fatty acid utilization and whether progestins will attenuate this effect, in a manner similar to what was seen in an observational study of hormone replacement therapy (HRT) in post-menopausal women. To this end, we had anticipated enrolling 30 healthy post-menopausal women for assessment of cardiac fatty acid metabolism using positron emission tomography (PET) and radioactive C[11]-Palmitate both before and after 3 days of hormone replacement therapy. These volunteers were to be randomized to receive either estrogen alone (E) or combined estrogen/progesterone (EP).|3 days|22 healthy post'menopausal women. These volunteers were to be randomized to receive either estrogen alone, or combined estrogen/progesterone. Efforts were made to access the data, PI left institution and there is no access to the data.|||Participants|||Count of Participants
2793600|NCT00565864|Other Pre-specified|% Fat Mass|% fat mass is measured by dual energy X-ray absorptiometry (DEXA). Measurements are made using a Hologic QDR Discovery A Densitometer (Hologic, Inc., Bedford, MA). Proprietary algorithms calculate % fat mass from DEXA data. Minimum value is 20%. Maximum value is 56%. For the purposes of this study, lower values are considered better.|24 weeks||||percentage of total mass||Standard Error|Mean
2793601|NCT00565864|Other Pre-specified|Lean Body Mass|Lean body mass (LBM) is measured by dual energy X-ray absorptiometry (DEXA). Measurements are made using a Hologic Discovery A Densitometer (Hologic, Inc., Bedford, MA). Proprietary algorithms calculate LBM from DEXA data. Minimum value is 28 kg. Maximum value is 71 kg. For the purposes of this study, higher values are considered better.|24 weeks||||kg||Standard Error|Mean
2793602|NCT00565864|Other Pre-specified|Body Mass Index|Body mass Index (BMI) is calculated as the weight in kg divided by the (height in meters squared). Minimum value is 18 kg/m2. Maximum value is 50 kg/m2. For the purposes of this study, lower values are considered better.|24 weeks||||kg/m2||Standard Error|Mean
2793667|NCT00565747|Primary|Ongoing Implantation Rate Week 7|Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.|Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)|PP-population|||percentage of transferred embryos|Participants||Number
2793603|NCT00565864|Other Pre-specified|Daily Energy Intake|Daily caloric intake is measured by 24-hour diet recalls, corrected for lean body mass (LBM). Three 24h food recall interviews are conducted by telephone within one week of the testing visit by research nutritionists trained in the Nutrition Data System for Research (NDSR), a software application for the collection of dietary recall information in a standardized fashion. Data from the phone interviews are manually entered into the NDSR program, which calculated caloric intake. The average of the three diet recalls is used as the outcome. Minimum value is 10 kcal/kg LBM/day. Maximum value is 72 kcal/kg LBM/day. Lower values are considered better for the purposes of this study.|24 weeks|One subject could not be reached by telephone to conduct the diet recalls.|||kcal/kg/day||Standard Error|Mean
2793604|NCT00565864|Other Pre-specified|Physical Activity Energy Expenditure|Physical activity energy expenditure (PAEE) by accelerometry, corrected for lean body mass. The Actical activity monitoring device (Mini Mitter Co Inc, Bend, OR) utilizes a multidirectional accelerometer to monitor the occurrence and intensity of motion, or epoch (137). The Actical device measures 3 cm by 3 cm, weighs 17.0 grams, and is securely attached to a waistband and placed around the waist. The device is worn for 7 days. Data are downloaded from the accelerometer using an ActiReader and converted into total activity counts, average activity (counts per minute), time interval duration (minutes), activity ranges during sedentary, light, moderate, and vigorous activity, and accumulated time within each activity range (minutes). These data are then converted to PAEE by proprietary algorithms. Minimum value is 3 kcal/kg LBM/day. Maximum value is 40 kcal/kg LBM/day. Higher values are better.|24 weeks|A few subjects did not have data collected due to a technical problem with downloading their data from the Actical device.|||kcal/kg LBM/day||Standard Error|Mean
2793605|NCT00565864|Other Pre-specified|Thermic Effect of Food|Thermic effect of food (TEF)is a measurement of energy expenditure over 5 hours following consumption of a standard test meal by indirect calorimetry. Each subject consumes a liquid mixed meal (Ensure, Ross Laboratories, 14% protein, 31.5% fat, and 54.5% carbohydrate) over 5 minutes and sampling for O2 and CO2 is then done by indirect calorimetry for the last 6 min of every 0.5 h for 5 h. For each metabolic measurement the respiratory exchange ratio (respiratory quotient or RQ = VCO2/VO2) is calculated and results converted to kilocalories by the Weir equation. Minimum value is 5 kcal/day. Maximum value is 730 kcal/day. Within this range, higher values are considered to be better for the purposes of this study.|24 weeks|The number of subjects who underwent measurement of thermic effect of food was less than the total number of subjects in the study due to scheduling constraints. TEF measurements take over 5 hours, and some subjects did not have sufficient time to participate in this part of the study, but were still able to conduct the other activities.|||kcal/day||Standard Error|Mean
2793606|NCT00565864|Other Pre-specified|Total Energy Expenditure|Total energy expenditure (TEE) measured by isotopic doubly labelled water (DLW) technique, corrected for lean body mass. A urine sample is collected and analyzed for background enrichment of deuterium and 18-O. The subject then drinks a dose of doubly labeled water at 1.7 gm per kg body weight, Samples are collected 2, 3 and 4 hours and seven days following the DLW dose to determine whole body equilibrium. Samples are measured as a ratio of deuterium to hydrogen in hydrogen gas and 18-O/ 16-O in CO2 using a Europa 20/20 Isotope Ratio Mass Spectrometer (Metabolic Solutions, Inc., Nashau, NH). CO2 production is then used to calculate TEE by Weir's equation. Minimum value is 36 kcal/kg LBM/day. Maximum value is 74 kcal/kg LBM/day. Within this range, higher values are considered to be better for the purposes of this study.|24 weeks|The number of participants analyzed is less than the total number of participants due to a nationwide shortage of doubly labelled water during the study. This meant that not all subjects entered into the study were able to receive the doubly labelled water.|||kcal/kg LBM/day||Standard Error|Mean
2793607|NCT00565864|Other Pre-specified|Motor Learning|Pursuit Rotor Trial 4. This test is performed on a photoelectric pursuit Rotor (Model 30014, Lafayette Instrument Company, Lafayette, IN). Subjects hold a photosensitive wand to maintain contact with a 2 cm. light disk rotating on a variable speed turntable. An initial block of 4 trials is administered at 15, 30, 45, and 60 revolutions per minute. The speed at which the subject remains on-target is the rate at which remaining trials are performed. Three blocks of eight 20-second trials are then administered, with a 20-sec rest after each trial, and a 60-sec rest period after 4 trials. This sequence is repeated after a retention interval of 30 minutes. The measure of interest here is the time the wand maintains on target during the final trial. Minimum score is 0; maximum score is 80 seconds. Higher numbers are better.|24 weeks||||seconds||Standard Error|Mean
2793608|NCT00565864|Other Pre-specified|Declarative Memory|Paragraph Recall - 30 min. Subjects were read a brief story and verbally recalled it immediately and after 30 minutes. The score was the total number of story elements recalled at 30 minutes. Minimum score is 0; Maximum score is 20. Higher scores are better.|24 weeks||||units on a scale||Standard Error|Mean
2793609|NCT00565864|Other Pre-specified|Working Memory|3-Back correct on target. The N-Back test consists of three conditions of increasing load on working memory, the 1-Back, 2-Back and 3-Back. In the 1-Back, letters are presented one at a time on a computer screen for 2 sec (1 sec interstimulus interval) during which the subject responds with a key press if a particular letter appears that had appeared on the previous screen. In the 2-Back, the subject must hold in mind letters and respond when s/he sees a letter that was previously presented two screens back. In the 3-Back, the subject responds when s'he sees a letter that was presented three screens back. N-back test measures the updating and storage functions of working memory. The test is scored as the number of targets correctly identified in each condition. The outcome of interest here is the number correct on target during the 3-Back, which is the most difficult of the three conditions. Minimum score is 0. Maximum score is 16. Higher scores are better.|24 weeks||||units on a scale||Standard Error|Mean
2793610|NCT00565864|Other Pre-specified|Mood|Profile of Mood States (POMS) fatigue subscale. The POMS consists of survey questions that cover 6 subscales: anxiety, confusion, depression-dejection, fatigue, tension, and vigor. Each subscale score is calculated from weighted averages of individual questions related to the subject's perception of fatigue. Minimum score for the fatigue subscale is 0. Maximum score is 30. Higher scores on the POMS fatigue subscale are worse.|24 weeks||||units on a scale||Standard Error|Mean
2793691|NCT00565643|Primary|Incidence of Adhesions|The Percentage of participants with one or more adhesions, regardless of the extent or severity|3 to 5 years||||percentage of patients with adhesions|||Number
2794144|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|4 months post operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793611|NCT00565864|Other Pre-specified|Quality of Life by SF-36 Survey|Short Form Survey (SF-36) mental component summary, which combines results from mental component subscales of the SF-36. The SF-36 health survey (SF-36) is a questionnaire about general health and well-being (127). It consists of 8 subscales (bodily pain, general health, mental health, physical functioning, vitality, role physical, social functioning, role emotional) and two summary scales (Mental Component and Physical Component Summaries). The mental component summary is a weighted average of the 8 subscales, with more weight to role emotional and mental health subscales. Minimum score for the SF-36 mental component summary is 14. Maximum score is 50. Higher scores on the SF-36 summary scales and subscales reflect better health status and well-being.|24 weeks||||units on a scale||Standard Error|Mean
2793612|NCT00565864|Primary|Resting Energy Expenditure|Measurement of resting energy expenditure (REE) by indirect calorimetry, corrected for lean body mass. Indirect calorimetry is performed at 21.1° C after the participant has fasted for 12h and abstains from significant physical activity for 24h. The indirect calorimeter (VMax Encore 29N Indirect Calorimeter, SensorMedics Viasys Healthcare, Yorba Linda, CA) samples expired air and analyzes it for the volume of oxygen consumed (VO2) and the volume of carbon dioxide produced (VCO2) each minute for 30mins. REE is then calculated using the modified Weir equation. Minimum REE is 23 kcal/kg LBM/day and maximum REE is 39 kcal/kg LBM/day. Within that range, higher levels are considered better for the purposes of this study.|24 weeks||||kcal/kg LBM/day||Standard Error|Mean
2793613|NCT00565864|Primary|Executive Function|Iowa Gambling Task Net-5. Four decks of cards are shown face down on a computer screen. The subject chooses cards from any deck, resulting in the gain or loss of money. The subject is unaware that 2 decks are advantageous (small gains, smaller losses), while 2 are disadvantageous (large gains, larger losses). The subject's choices are classified as advantageous (X) or disadvantageous (Y), with a net score of X-Y, over 5 trials of 100 cards each. The outcome reported here is the score on the fifth trial, which is generally the best trial due to practice effects. The minimum score is -20 and the maximum score is +20. Higher scores indicate a better outcome.|24 weeks||||units on a scale||Standard Error|Mean
2793614|NCT00565812|Other Pre-specified|Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96||Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||beats per minute (bpm)||Standard Deviation|Mean
2793615|NCT00565812|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||mmHg||Standard Deviation|Mean
2793616|NCT00565812|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2793617|NCT00565812|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN or greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil:<0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, lipase >1.5*ULN; urine (specific gravity <1.003 or >1.030, pH <4.5 or >8, glucose, ketones, protein, blood/Hgb greater than or equal to [>=]1); pancreatic amylase >1.5*ULN.|Baseline up to Week 111|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
2793618|NCT00565812|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than [>]140 milliseconds [msec]), junctional/paced rhythm, intraventricular conduction delay (>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.|Baseline, Month 3, 6, 12, 18, 24|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793692|NCT00565617|Primary|HDRS-24 Items|"Hamilton Depression Rating Scale (HDRS) is a standard, validated depression rating scale.~It is a 24 item scale, but the primary score is based on the first 17 answers for a total score for depression.~0-7=Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression > 23 = Very Severe Depression"|7 months from baseline||||units on a scale||Standard Deviation|Mean
2793619|NCT00565812|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 7-10 days after last dose of study drug (Week 111)|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication.|||participants|||Number
2793620|NCT00565812|Secondary|Number of Participants Applicable for Virtual Joint Replacement|A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
2793621|NCT00565812|Secondary|Number of Participants With Joint Space Narrowing Progression|JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
2793622|NCT00565812|Secondary|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index|The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 [minimum] to 5 [maximum], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||participants|||Number
2793623|NCT00565812|Secondary|Patient Global Impression of Change Score|Patient global impression of change was a participant-rated instrument that measured change in participant's overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2793624|NCT00565812|Secondary|Number of Participants With Decrease in Total Analgesic Medication Use|Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793625|NCT00565812|Secondary|Number of Participants With Increase in Total Analgesic Medication Use|Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793626|NCT00565812|Secondary|EuroQoL-5D Visual Analog Scale Score|The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793627|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793628|NCT00565812|Secondary|Number of Participants With EuroQo-5D Pain and Discomfort Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793629|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Usual Activity Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793630|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Self-Care Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793631|NCT00565812|Secondary|Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||participants|||Number
2793632|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793633|NCT00565812|Secondary|Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793634|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793635|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793643|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24|The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793636|NCT00565812|Secondary|Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793637|NCT00565812|Secondary|Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793638|NCT00565812|Secondary|Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793639|NCT00565812|Secondary|Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793640|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793641|NCT00565812|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793642|NCT00565812|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24|The KOOS-PS was used to rate participant's opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793693|NCT00565604|Secondary|Secondary Safety Objective|Safety: Incidence rate of device-related minor adverse events.|6 Months|The number of subjects that were enrolled in the trial.|||Participants|||Number
2793644|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793645|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793646|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24|The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluated for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793647|NCT00565812|Secondary|Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24|The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793648|NCT00565812|Secondary|Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793649|NCT00565812|Secondary|Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition."|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793650|NCT00565812|Secondary|Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24|Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||mm||Standard Deviation|Mean
2793651|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793652|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24|Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793653|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793654|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24|The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2793655|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.|||mm/year||Standard Deviation|Mean
2793656|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG <=2 and evaluable for this outcome measure.|||mm/year||Standard Deviation|Mean
2793657|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing|Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.|||mm/year||Standard Deviation|Mean
2793658|NCT00565773|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Graft function was assessed throughout the study by the estimated glomerular filtration rate. The eGFR indicates the percentage of kidney function that a person has based on creatinine, age, body size, and gender. An eGFR of below 60 indicates chronic kidney disease. A higher eGFR means that there is greater kidney function.|Year 1, Year 3, Year 5|Between the 3 and 5 year assessments, one participant was removed for no longer meeting eligibility criteria and one participant withdrew from the study.|||mL/min/1.73m^2||Standard Deviation|Mean
2793659|NCT00565773|Secondary|Number of Participants With Surviving Grafts|The number of participants whose grafts survived without graft failure at each follow up time point is presented here.|Year 1, Year 3, Year 5|Between the 3 and 5 year assessments, one participant was removed for no longer meeting eligibility criteria and one participant withdrew from the study.|||Participants|||Count of Participants
2793660|NCT00565773|Secondary|Number of Participants Developing Donor-specific Alloantibody (DSA)|Long term assessment of donor-specific immune responsiveness after prolonged therapy with belatacept (with or without sirolimus), and during and following drug withdrawal as determined by in vitro alloresponsiveness in carboxyfluorescein succinimidyl ester (CFSE) mixed lymphocyte reactivity and intracellular cytokine staining (ICCS).|Up to Year 5||||Participants|||Count of Participants
2793661|NCT00565773|Secondary|Number of Participants With BK Viremia|The number of participants experiencing BK viremia, an opportunistic infection, during the study is presented here.|Up to Year 5||||Participants|||Count of Participants
2793662|NCT00565773|Secondary|Number of Participants Experiencing Chronic Allograft Nephropathy (CAN)|Assessment of biopsy proven chronic allograft nephropathy at 1, 3 and 5 years post-transplant is presented as the number of participants experiencing CAN.|Year 1, Year 3, Year 5|Between the 3 and 5 year assessments, one participant was removed for no longer meeting eligibility criteria and one participant withdrew from the study.|||Participants|||Count of Participants
2793663|NCT00565773|Secondary|Number of Participants Experiencing Costimulation Blockade-resistant Rejection (CoBRR)|Assessment of the proposed therapies to prevent biopsy proven acute rejection, also known as CoBRR, was determined by the number of participants experiencing CoBRR at 1, 3 and 5 years post-transplant.|Year 1, Year 3, Year 5|Between the 3 and 5 year assessments, one participant was removed for no longer meeting eligibility criteria and one participant withdrew from the study.|||Participants|||Count of Participants
2793664|NCT00565773|Primary|Number of Patients Successfully Withdrawn From Oral Immunosuppression|The primary endpoint is the number of patients successfully withdrawn from oral immunosuppression (sirolimus) for one year after their last dose of sirolimus. After taking sirolimus for one year, participants meeting certain pre-specified criteria were offered the opportunity to wean from sirolimus and continue with belatacept monotherapy. To be eligible for weaning of sirolimus, participants were required to have a kidney biopsy negative for all signs of rejection, including borderline findings.|Year 2|This analysis includes participants meeting criteria to wean from sirolimus who also opted to attempt sirolimus weaning.|||Participants|||Count of Participants
2793665|NCT00565747|Secondary|Live Birth|Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria).|Until 7 days after birth|PP-population|||percentage of transfer patients|||Number
2793668|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793669|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793670|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793671|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793672|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793673|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793674|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793675|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793676|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793677|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).|||Correlation coefficient||95% Confidence Interval|Number
2793678|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.~Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC.~SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793679|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.~SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793680|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793681|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation.~Two (2) of the 22 subjects did not have any αvβ5 integrin results."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793682|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.~The Logan plot is the counterpart of the Patlak plot for reversible radiotracers."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793683|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation.~Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.|||Correlation coefficient||95% Confidence Interval|Number
2793684|NCT00565669|Primary|Change in Schirmer's Scores|The Schirmer score is a score on a scale - minimum is 0 and the highest is 35 mm. Above 15 mm is normal and less than 5 is severe dry eyes. A positive score means there was an improvement, 0 will be no change from baseline and a negative one that there was a decreased in tears. This change was calculated by subtracting the baseline value from the 3 months value (3 mo Schirmer's - baseline Schirmer's = amount of change).|baseline to 3 months||||score on a scale||Standard Error|Mean
2793685|NCT00565643|Secondary|Operative Times at Subsequent Delivery|Amount of time spent at the time of the subsequent delivery|3 to 5 years||||minutes||Full Range|Median
2793686|NCT00565643|Secondary|Post-operative Maximum Temperature Following Randomization|Maximum temperature of patient, >24 hours following randomization delivery|1 to 5 years||||degrees Fahrenheit||Standard Deviation|Mean
2793687|NCT00565643|Secondary|Post-Operative Complications|Percentage of patients experiencing any of the predefined post-operative complications following randomization|1 to 5 years||||% of patients experiencing complication|||Number
2793688|NCT00565643|Secondary|Post-operative White Blood Cell Count|Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups|1 to 5 years||||cells/mm^3||Standard Deviation|Mean
2793689|NCT00565643|Primary|Adhesion Score|Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).|3 to 5 years||||units on a scale||Full Range|Median
2793690|NCT00565643|Secondary|Post-operative Hemoglobin|Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups|1 to 5 years||||% of blood that is red blood cells||Standard Deviation|Mean
2793694|NCT00565604|Secondary|Secondary Effectiveness Objective|Effectiveness: The reduction in patient symptoms and the satisfaction of the patient. Patient symptom assessment - CEAP Class, best=0 (no visible or palpable signs of venous disease) & worst=6 (Skin changes in conjunction with active ulceration), VDS, best=0 (asymptomatic) & worst=3 (unable to carry out usual activities even with compression and/or limb elevation) and VCSS, best=0 (absent) & worst=3 (severe). Patient satisfaction - modified Odom's criteria, best=excellent (I am very satisfied with the results of my laser treatment) & worst=poor (I am not satisfied with the results).|6 Months|The number of patients still participating in the study at 6-months.|||Participants|||Number
2793695|NCT00565604|Primary|Primary Safety Objective|Safety: Evaluation of occurrence of major device-related adverse events through 6 weeks and the total at 6 months.|6 Months|The number of patients that were enrolled in the study.|||Participants|||Number
2793696|NCT00565604|Primary|Primary Effectiveness Objective|The primary objective is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated incompetent perforated vein [IPV])) of endovenous laser ablation. The number of treated IPVs that are closed at 6 weeks and remain closed at 6 months.|6 Months|The number of patients still participating in the study at 6-months.|||Treated IPVs|Participants||Number
2793697|NCT00565461|Secondary|Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic||6 months|Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.|||Percent of Participants||95% Confidence Interval|Number
2793698|NCT00565461|Secondary|Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic||6 months|Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.|||fold change||95% Confidence Interval|Number
2793699|NCT00565461|Secondary|Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine||6 months|The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.|||Percent of Participants||95% Confidence Interval|Number
2793700|NCT00565461|Secondary|Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine||6 months|The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.|||fold change||95% Confidence Interval|Number
2793701|NCT00565461|Secondary|Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.||6 months|Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.|||titers||95% Confidence Interval|Geometric Mean
2793702|NCT00565461|Secondary|Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.||6 months|Number Analyzed in Outcome Measure Data Table: in Group 3 only 39 subjects received the second vaccination.|||Events|||Number
2793703|NCT00565461|Secondary|Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.||6 months|The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.|||titers||95% Confidence Interval|Geometric Mean
2793704|NCT00565461|Secondary|Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch||6 months|Number analyzed in the Outcome Measure Data Teble are the number of subjects with events|||Events|||Number
2793705|NCT00565461|Primary|Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA"|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology|||percentage of study participants||95% Confidence Interval|Number
2793706|NCT00565461|Primary|GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data."|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology|||geometric mean fold ratio||95% Confidence Interval|Number
2793707|NCT00565461|Primary|GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~GMT: geometric mean titer"|Day 0, Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology|||geometric mean titers||95% Confidence Interval|Geometric Mean
2794145|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793708|NCT00565448|Secondary|Overall Survival (OS) Rate|OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period. The Kaplan-Meier method was used to estimate OS rate.|3 years after the end of the consolidation treatment period (up to 40 months from randomization)|ITT population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2793709|NCT00565448|Secondary|Overall Response (OR)|OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as ≥30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry. PD is defined as ≥20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of ≥1 new lesions or unequivocal progression of non-TLs. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|after the completion of the consolidation treatment (up to 18 weeks)|ITT population: all randomized participants.|||participants|||Number
2793710|NCT00565448|Secondary|Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group|AUC estimated by Bayesian method using concentration-time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).|Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion|Participants who were randomized to docetaxel/cisplatin/5-FU and had evaluable docetaxel pharmacokinetic (PK) sample.|||µg*h/mL||Standard Deviation|Mean
2793711|NCT00565448|Primary|Number of Participants With Complete Response (CR)|CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.|after the completion of the induction treatment (up to 9 weeks)|ITT population: all randomized participants.|||participants|||Number
2793712|NCT00565409|Secondary|DAS28 at Week 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm).|Week 36|P2 mITT; LOCF|||units on a scale||Standard Error|Mean
2793713|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR90 response: ≥ 90% improvement in tender joint count; = 90% improvement in swollen joint count; and = 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||percentage of participants|||Number
2793714|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR90 response: ≥ 90% improvement in tender joint count; = ≥90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; LOCF|||percentage of participants|||Number
2793715|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and C-Reactive Protein CRP.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793716|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793717|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793718|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793719|NCT00565409|Secondary|Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR20 response: ≥ 20% improvement in tender joint count; ≥20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data|||percentage of participants|||Number
2793720|NCT00565409|Secondary|Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36|ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793721|NCT00565409|Secondary|Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Week 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793722|NCT00565409|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793723|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Weeks 36, 64 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants|||Number
2793724|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Baseline, Week 36|P1 mITT; N=number of participants with evaluable data; LOCF|||percentage of participants||95% Confidence Interval|Number
2793725|NCT00565409|Secondary|Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||mm||Standard Error|Least Squares Mean
2793726|NCT00565409|Secondary|Pain at Week 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation.|Week 36|P2 mITT; LOCF|||mm||Standard Error|Mean
2793727|NCT00565409|Secondary|Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||mm||Standard Error|Mean
2793728|NCT00565409|Secondary|Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88|"General Health VAS is a 100 mm line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation."|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF|||mm||Standard Error|Least Squares Mean
2793729|NCT00565409|Secondary|General Health at Week 36|"General Health VAS is a 100 mm line marked by the participant. Participants are asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad."|Week 36|P2 mITT; LOCF|||mm||Standard Error|Mean
2793730|NCT00565409|Secondary|Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36|"General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation."|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||mm||Standard Deviation|Mean
2793731|NCT00565409|Secondary|Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF|||min||Standard Error|Least Squares Mean
2793732|NCT00565409|Secondary|Duration of Morning Stiffness at Week 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded.|Week 36|P2 mITT; N=number of participants with evaluable data; LOCF|||min||Standard Error|Mean
2793733|NCT00565409|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times [*] 60 min) was recorded. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||minutes (min)||Standard Deviation|Mean
2793734|NCT00565409|Secondary|Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; LOCF|||units on a scale||Standard Error|Least Squares Mean
2793735|NCT00565409|Secondary|PtGA of Arthritis Pain at Week 36|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).|Week 36|P2 mITT; LOCF|||units on a scale||Standard Error|Mean
2793736|NCT00565409|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36|Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||units on a scale||Standard Error|Mean
2793737|NCT00565409|Secondary|Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||units on a scale||Standard Error|Least Squares Mean
2793738|NCT00565409|Secondary|PGA Score at Week 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.|Week 36|P2 mITT; LOCF|||units on a scale||Standard Error|Mean
2793739|NCT00565409|Secondary|Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||units on a scale||Standard Error|Mean
2793740|NCT00565409|Secondary|Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Weeks 36 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF|||number of painful joints||Standard Error|Least Squares Mean
2793741|NCT00565409|Secondary|Painful Joint Count at Week 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.|Week 36|P2 mITT; LOCF|||number of painful joints||Standard Error|Mean
2793742|NCT00565409|Secondary|Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||number of painful joints||Standard Error|Mean
2793743|NCT00565409|Secondary|Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF|||number of swollen joints||Standard Error|Least Squares Mean
2793744|NCT00565409|Secondary|Prorated Swollen Joint Count at Week 36|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by number of non-missing swollen joints). Total possible score of swollen joints ranged from 0-28.|Week 36|P2 mITT; LOCF|||number of swollen joints||Standard Error|Mean
2793745|NCT00565409|Secondary|Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36|American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF|||number of swollen joints||Standard Error|Mean
2793746|NCT00565409|Secondary|Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88|DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 < 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88.|Week 36 up to Week 88|P2 mITT; LOCF|||proportion of weeks in DAS28 <3.2||Standard Error|Mean
2793747|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;|||days||95% Confidence Interval|Median
2793748|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 ≤ 3.2 units. DAS28 > 3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;Imputation of failure; observed cases|||days||95% Confidence Interval|Median
2793749|NCT00565409|Secondary|Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data|||units on a scale||Standard Error|Least Squares Mean
2793750|NCT00565409|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; Last observation carried forward (LOCF); N=Number of participants with evaluable data|||units on a scale||Standard Error|Mean
2793751|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|Period 2 (P2) mITT|||Percentage of participants|||Number
2793752|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Baseline, Weeks 4, 8, 12, 20, 28, 36|Period 1 Modified Intent to Treat population (P1 mITT): all participants who took at least 1 dose of open-label test article; N=number of participants with evaluable data; Last observation carried forward (LOCF)|||percentage of participants|||Number
2793753|NCT00565409|Primary|Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than [<]20 percent [%] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.|Week 88|Modified Intent to Treat population (mITT): all participants who took at least 1 dose of double-blind test article and had at least 1 post-randomization DAS28 evaluation|||percentage of participants|||Number
2793754|NCT00565370|Secondary|Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib|28weeks||||participants|||Number
2793755|NCT00565370|Secondary|Overall Survival||28 months||||Months||95% Confidence Interval|Median
2793756|NCT00565370|Secondary|Response Rate|"Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate"|6 months|Patients who had measurable lesions were included for the response rates|||percentage of participants||95% Confidence Interval|Number
2793757|NCT00565370|Primary|Progression-free Survival||1 year||||Months||95% Confidence Interval|Median
2793758|NCT00565370|Primary|Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)|Number of Participants who Experienced Dose Limiting Toxicities (DLTs)|28weeks||||participants|||Number
2793759|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Proportion of Asthma Control Days|An asthma control day was defined as a day in which there were no symptoms and no albuterol (rescue) puffs.|An asthma control day was determined daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||proportion of asthma control days||Standard Error|Least Squares Mean
2793760|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Albuterol Rescue Puffs Per Day|Total number of puffs from the albuterol (rescue) inhaler during the previous 24 hours (excluding those puffs for preventive use).|Albuterol rescue puffs were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||puffs per day||Standard Error|Least Squares Mean
2794146|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793761|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Asthma Control Questionnaire Score|Scores on the Asthma Control Questionnaire range from 0 to 6, with a higher score indicating worse asthma control.|The asthma control questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
2793762|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Asthma Quality-of-life Questionnaire Score|Scores on the Asthma Quality-of-Life Questionnaire range from 1 to 7, with a higher score indicating a better quality of life.|The asthma quality-of-life questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
2793763|NCT00565266|Secondary|Change Between Week 14 and Week 0 in Asthma Symptoms|"Asthma symptoms were recorded as 0 (absent = no symptom )~(mild = symptom was minimally troublesome, i.e. not sufficient to interfere with normal daily activity or sleep)~(moderate = symptom was sufficiently troublesome to interfere with normal daily activity or sleep)~(severe = symptom was so severe as to prevent normal activity and/or sleep )"|Asthma symptoms were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
2793764|NCT00565266|Secondary|Change Between Week 14 and Week 0 in the Forced Expiratory Volume in One Second (FEV1)||FEV1 was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters||Standard Error|Least Squares Mean
2793765|NCT00565266|Primary|Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)||AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||Liters per minute||Standard Error|Least Squares Mean
2793766|NCT00565136|Other Pre-specified|Pudendal Nerve Terminal Motor Latency|Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.|Baseline (pre-treatment), 6 Month post-treatment||||msec||Standard Deviation|Mean
2793767|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Tolerable Volume||Baseline (pre-treatment), 6 Month post-treatment||||cc||Standard Deviation|Mean
2793768|NCT00565136|Other Pre-specified|Anal Manometry: Rectal First Sensation||Baseline (pre-treatment), 6 Month post-treatment||||cc||Standard Deviation|Mean
2793769|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Squeeze Pressure||Baseline (pre-treatment), 6 Month post-treatment||||mmHg||Standard Deviation|Mean
2793770|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Resting Pressure||Baseline (pre-treatment), 6 Month post-treatment||||mmHg||Standard Deviation|Mean
2793771|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure||Duration of the device implant procedure (an average of 23 minutes)|All enrolled/implanted subjects were included in this analysis|||ml||Standard Deviation|Mean
2793772|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Hospital Stay||Length of the hospital stay for the device implant procedure|All enrolled/implanted subjects were included in this analysis|||hours||Standard Deviation|Mean
2793773|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Procedure||Duration of the device implant procedure|All enrolled/implanted subjects were included in this analysis|||minutes||Standard Deviation|Mean
2793774|NCT00565136|Secondary|Pain Intensity as Measured by the Pain Intensity Scale|The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.|Baseline (pre-treatment), 6 Week post-treatment|"The Pain Intensity Scale was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29"|||units on a scale||Standard Deviation|Mean
2793775|NCT00565136|Secondary|Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life|The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.|Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows:~Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"|||units on a scale||Standard Deviation|Mean
2793776|NCT00565136|Post-Hoc|Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline|Includes solid and liquid stools, as measured by a subject-reported bowel diary|6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure.~The Bowel Diary was completed by the number of subjects at each visit as follows:~6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24"|||percentage participants||90% Confidence Interval|Number
2793777|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence|The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1-6, 7-10, and 11-13 were categorized as mild, moderate, and severe fecal incontinence, respectively.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"|||units on a scale||Standard Deviation|Mean
2793778|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by the Wexner Score|The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Wexner Score was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"|||units on a scale||Standard Deviation|Mean
2793779|NCT00565136|Secondary|Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period|Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)|Through 24 month post-treatment|Includes all subjects implanted with the TOPAS device|||events per 24 months/participant|||Number
2793780|NCT00565136|Primary|Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment|Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The FI Bowel Diary was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26"|||Number of FI episodes/14 day period||Standard Deviation|Mean
2793781|NCT00565110|Secondary|Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey|The SF-12 measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. PCS is a summary score measuring physical health derived by summing responses across scale items and then transforming to a 0-100 scale (higher scores indicate better health).|12 months||||units on a scale||Standard Error|Mean
2793782|NCT00565110|Primary|Reduced Depression Symptoms|Number of participants with 50% PHQ-9 score reduction since baseline|12 months||||Participants|||Count of Participants
2793783|NCT00565084|Primary|Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks|"Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.~Change from baseline was average of post-dose PIs minus average of pre-dose PI."|All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)|This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.|||Units on a Scale||Standard Deviation|Least Squares Mean
2793784|NCT00565058|Secondary|Summary of Treatment Emergent Adverse Events|An adverse event (AE) was defined as any unintended or undesirable experience that occurred during the course of the clinical investigation, regardless of whether or not it was considered to be study drug-related. This included any newly occurring event or a previous condition that had increased in severity or frequency since the administration of study drug.|30 days after the last dose|All Treated Patients population.|||participants|||Number
2793785|NCT00565058|Primary|Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML|Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.|at 29-35 days|All Treated Patients population|||participants|||Number
2793786|NCT00565045|Secondary|Fugl-Meyer Assessment (Upper Extremity)|The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.|||units on a scale||Standard Error|Mean
2793787|NCT00565045|Secondary|Arm Motor Abilities Test|The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.|||units on a scale||Standard Error|Mean
2793788|NCT00565045|Secondary|Box and Blocks Score|The number of blocks picked up and moved across a barrier in 60 seconds|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.|||blocks||Standard Error|Mean
2793789|NCT00565045|Secondary|Finger Tracking Error|A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.|||% AROM||Standard Error|Mean
2793802|NCT00564902|Secondary|Glare Recovery|Photostress glare recovery test involves exposing an individual eye to intense light, or retinal bleach, for a set duration of time and measuring the time taken for visual acuity to recover to a predetermined level. Glare photo-stress recovery (in seconds) following 30 seconds of continuous retinal bleach, was assessed using 2 line supra-threshold low contrast randomly presented Landolt Cs using the KOWA AS14B Night Vision Tester (KOWA Optimed, Tokyo, Japan).|12 Months|Eyes of all patients still in the trial were measured|||Seconds||Standard Error|Mean
2793790|NCT00565045|Primary|Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)|A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.|||degrees||Standard Error|Mean
2793791|NCT00564954|Primary|Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0 hr and 0.5 hr post-dose|Intent to Treat (ITT) population: All randomized patients who had at least one dose of study medication and who had at least one post-dose efficacy measurement.|||score on a scale||Standard Error|Least Squares Mean
2793792|NCT00564954|Secondary|Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test|Number of math questions answered correctly within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.|||questions correct||Standard Error|Least Squares Mean
2793793|NCT00564954|Secondary|Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)|Number of math questions attempted within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population|||questions attempted||Standard Error|Least Squares Mean
2793794|NCT00564954|Secondary|Change From Pre-dose in SKAMP Deportment Score|SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.|||score on a scale||Standard Error|Least Squares Mean
2793795|NCT00564954|Secondary|Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)|SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.|0, 0.5, 1, 2, 4, 6, and 8 hours|Intent to Treat (ITT) population|||score on a scale||Standard Error|Least Squares Mean
2793796|NCT00564954|Secondary|Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0, 1, 2, 4, 6, and 8 hr|Intent to Treat (ITT) population|||score on a scale||Standard Error|Least Squares Mean
2793797|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering light emitting diodes and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated.|12 months|All participants in all arms were tested|||Density units of Macular Pigment (du)||Standard Error|Mean
2793798|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|8 months|All participants in all arms were tested|||Density units of Macular Pigment (du)||Standard Error|Mean
2793799|NCT00564902|Secondary|100% Kinetic Field|Scotomas within the central 20 degree central macula visual field sensitivity was assessed at 5 contrast levels (20, 40, 60, 80, and full contrast). A yellow wavelength stimulus avoided confounding by the lens. Subjects outlined the boundaries of their scotoma(s) on an area-integrating and recording touch flat- screen RGB monitor displaying a central fixation point and movable horizontal/vertical raster lines. The computer calculated summed area of the scotoma(s) with arbitrary scaling from 6000 (dense scotoma) to 0 relative units (absence of scotoma).|12 Months|Eyes of all patients still in the trial were measured|||Units on a scale (0 to 6000)||Standard Error|Mean
2793800|NCT00564902|Secondary|6.5 Degrees Tritan Threshold|The ChromaTest© is a computerized psychophysical test of protan and tritan color thresholds against age-corrected data. The computer finds the endpoint of the test by a Modified Binary Search method; if response is correct, on the next presentation the color difference between letter and background is halved. If response is incorrect, the color -contrast is doubled. Incorrect responses prolong the test, but do not influence the final threshold. This method of determining thresholds leads to finite steps which reach a plateau at the color contrast sensitivity threshold.|12 months|Eyes of all patients still in the trial were measured|||dB||Standard Error|Mean
2793801|NCT00564902|Secondary|Contrast Sensitivity Function Photopic Distance|Distance photopic contrast sensitivity function (CSF) at 5 spatial frequencies (1.5, 3, 6, 12 & 20 cc/deg) was determined with the Functional Vision Analyzer® (Stereo Optical Co, Inc, Chicago, IL). Contrast sensitivity readings are shown as a curve. Visual acuity is plotted along the horizontal axis and contrast sensitivity along the vertical axis. Among the normally sighted people, both visual acuity and contrast sensitivity have a wide range of variation.Low population CSF is 0-200 units; normal population CSF is 200-300 units and suprathreshold CSF is 300+ units.|12 Months|Eyes of all patients still in the trial were measured|||units on a scale||Standard Error|Mean
2793872|NCT00563797|Secondary|Mean Percentage of Number of Drinking Days by Smoking Status|Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo.|25 weeks||||Percentage of Drinking Days||Standard Deviation|Mean
2793803|NCT00564902|Secondary|Early Treatment Diabetic Retinopathy Study Distance Visual Acuity|Black and 10% contrast near reading visual acuity was assessed with a Colenbrander Mixed Contrast Reading Card with LogMAR letters (#4031, Precision Vision, LaSalle, Illinois). We determined single letter acuity on an ordinal VAS (Visual Acuity Scale). The largest letters were 0.05 LogMAR with a VAS = 35 while the most difficult smallest letters were LogMar 1.25 or VAS 105. The test card was held at 40 cm with best monocular refraction, and both low and high contrast letter acuity were assessed.|12 months|Eyes of all patients still in the trial were measured|||units on a scale||Standard Error|Mean
2793804|NCT00564902|Secondary|SHAPE Discrimination|We determined the target deformation detection thresholds, or amplitude of the minimum detectable distortion of a 1 degree foveal circular target. The peak spatial frequency of RF (radial frequency) patterns was 5 cyc/deg; the radial modulation frequency was 8 cyc/360°; mean radii were 0.5°, 1°, 2.0°, or 2.5°; and stimulus contrast was 80%. The highest % modulation score possible is 0.13 while the easiest (lowest score) was 10% modulation.|12 months|Eyes of all participants still in the trial were measured|||% modulation||Standard Deviation|Mean
2793805|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|4 months|All participants in all arms were tested|||Density units of Macular Pigment (du)||Standard Error|Mean
2793806|NCT00564889|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)||||months||95% Confidence Interval|Median
2793807|NCT00564889|Secondary|Progression Free Survival (PFS)|Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)||||months||95% Confidence Interval|Median
2793808|NCT00564889|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Duration of study (up to 3 years)||||participants|||Number
2793809|NCT00564889|Secondary|Number of Patients With Organ Response|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|Duration of study (up to 3 years)||||participants|||Number
2793810|NCT00564889|Primary|Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)|"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration on study (up to 3 years)||||participants|||Number
2793811|NCT00564876|Secondary|Safety and Tolerability of Adjuvant Dasatinib|Determine the safety and tolerability of adjuvant dasatinib in early stage NSCLC.|Duration of adjuvant treatment plus 30 days.|Due to insufficient accrual, data analysis was not performed.||||||
2793812|NCT00564876|Secondary|Gene Expression Profile Activation of Src Pathways|Determine whether gene expression profile activation of Src pathways is correlated with anti-tumor activity of dasatinib in early stage NSCLC.|Baseline and after 3 weeks of dasatinib therapy at the time of definitive surgical resection.|Due to insufficient accrual, data analysis was not performed.||||||
2793813|NCT00564876|Secondary|Safety and Tolerability of Neoadjuvant Dasatinib|Determine the safety and tolerability of neoadjuvant dasatinib in early stage NSCLC.|Screening / Baseline; Neoadjuvant dasatinib Cycle 1 Day 1 and Day 22|Due to insufficient accrual, data analysis was not performed.||||||
2793814|NCT00564876|Primary|Response Rate|Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib|First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly.|||||||
2793815|NCT00564850|Secondary|Triptorelin Plasma Levels||Month 1, 2, 3, 4, 5 and 6|Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.|||ng/mL||Standard Deviation|Mean
2793816|NCT00564850|Secondary|Uterine Length||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.|||mm||Standard Deviation|Mean
2793817|NCT00564850|Secondary|Difference Between Bone Age and Chronological Age|Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.|Month 0 and 6|Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.|||years||Standard Deviation|Mean
2794147|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793818|NCT00564850|Secondary|Change From Baseline in Growth Velocity (GV) SDS at Month 6|"Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.~Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures."|Baseline and month 6|Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.|||SD score||Standard Deviation|Mean
2793819|NCT00564850|Secondary|Body Mass Index (BMI) SDS||Month 0, 3 and 6|Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.|||SD score||Standard Deviation|Mean
2793820|NCT00564850|Secondary|Height Standard Deviation Score (SDS)|Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.|Month 0, 3 and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 6.|||SD score||Standard Deviation|Mean
2793821|NCT00564850|Secondary|Change From Screening in Pubertal Stage (Tanner Method) at Month 6|Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.|Between screening and month 6|Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.|||participants|||Number
2793822|NCT00564850|Secondary|Number of Girls With Inhibin B Levels < 6 pg/ml||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.|||participants|||Number
2793823|NCT00564850|Secondary|Testosterone Level||Month 0, 3 and 6|Testosterone level from the male patient in the ITT population.|||ng/ml|||Number
2793824|NCT00564850|Secondary|Number of Girls With Oestradiol Levels ≤ 20 pg/ml||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.|||participants|||Number
2793825|NCT00564850|Secondary|Basal LH Level||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.|||IU/L||Standard Deviation|Mean
2793826|NCT00564850|Secondary|Basal FSH Level||Month 0, 1, 2, 3, 4, 5, and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.|||IU/L||Standard Deviation|Mean
2793827|NCT00564850|Secondary|Follicle Stimulating Hormone (FSH) Level Following GnRH Test||Screening, month 3 and 6|Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.|||IU/L||Standard Deviation|Mean
2793828|NCT00564850|Secondary|Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L||Month 6|"Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. n indicates the number of patients who had an assessment at the visit."|||participants|||Number
2793829|NCT00564850|Primary|Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L||3 months after the first injection of triptorelin pamoate 11.25 mg|"Analyses performed on:~Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder.~Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion.~Per Protocol (PP): all mITT patients without major protocol deviations."|||participants|||Number
2793830|NCT00564733|Primary|Overall Response Rate (Patients That Achieve a CR or PR)|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At the end of 4 cycles of treatment, up to 24 weeks.|All patients that signed consent and received at least one cycle of chemotherapy.|||participants|||Number
2793831|NCT00564681|Secondary|Duration of Treatment Effect for Treatment Responders|Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).|Up to 6 Months|Intent-to-Treat: All enrolled patients|||Days||95% Confidence Interval|Median
2793832|NCT00564681|Secondary|Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1|Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).|Baseline, Week 4|Intent-to-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
2793833|NCT00564681|Secondary|Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
2794123|NCT00561652|Other Pre-specified|"Participant Adherence With Time and Attention Visits"|"Number of participants who completed at least 8 of 10 time and attention visits. Note that only arm 1 (nonchiropractic arm) receives time and attention visits."|12 weeks|"Only arm 1 received time and attention visits as their purpose was to balance the chiropractor provider contact time received by arm 2 participants."|||participants|||Number
2793834|NCT00564681|Secondary|Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
2793835|NCT00564681|Primary|Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1|Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.|Baseline, Week 4|Intent-To-Treat: All enrolled patients|||Scores on a Scale||Standard Deviation|Mean
2793836|NCT00564629|Secondary|WSTD6|This outcome measure is a statistical analysis of WSTD6, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 6 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-6 hours||||degrees Celsius||Standard Deviation|Mean
2793837|NCT00564629|Secondary|WSTD5|This outcome measure is a statistical analysis of WSTD5, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 5 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-5 hours||||degrees Celsius||Standard Deviation|Mean
2793838|NCT00564629|Secondary|WSTD4|This outcome measure is a statistical analysis of WSTD4, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 4 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-4 hours||||degrees Celsius||Standard Deviation|Mean
2793839|NCT00564629|Secondary|WSTD3|This outcome measure is a statistical analysis of WSTD3, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 3 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-3 hours||||degrees Celsius||Standard Deviation|Mean
2793840|NCT00564629|Secondary|The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes|This outcome measures what percentage of total subjects had a temperature < 38 ºC and < 38.5 ºC at any timepoint during the time from T0 to T360 minutes.|T0 to T360 minutes|Analysis performed on mITT population.|||percentage of participants|||Number
2793841|NCT00564629|Secondary|Subject's Global Evaluation of Study Medication at T360 Minutes|"This outcome measures how satisfied the subject was with the study treatment. The subject was asked to answer Overall, how would you rate study treatments? at T360 minutes using a 4-point categorical scale (0=poor, 1=fair, 2=good, 3=excellent)."|T360 minutes|Analysis performed on the mITT population.|||participants|||Number
2793842|NCT00564629|Secondary|Maximum Temperature Reduction Observed From T0 to T360 Minutes|This outcome measures the maximum core temperature reduction observed from T0 to T360 minutes. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|T0-T360 minutes|Analysis performed on the mITT population.|||Degrees Celsius||Standard Deviation|Mean
2793843|NCT00564629|Secondary|Time to a Reduction in Temperature From T0 to T360 Minutes.|This outcome measures how much time it took to observe a decrease in subjects' core body temperature by 0.8 ºC, 1.0 ºC, and 1.5 ºC from the temperature at T0 and from the temperature at the peak after T0 through T360 (6 hours). The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|6 hours|Analysis was performed on the mITT population.|||Hours||Standard Deviation|Mean
2793844|NCT00564629|Primary|The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2)|This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-2 hours|mITT population defined as all randomized subjects who received at least 1 full dose of oral study medication (subject not vomiting within 2 hours after oral study drug) or 1 full dose of IV study medication(subject having received all 100 mls solution). This analysis was performed with imputation for non-physiological temperature swing zone effect|||Degrees Celsius||Standard Deviation|Mean
2793845|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event|"The number of subjects who reported at least one treatment emergent SAE during the study.~A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose to 30 days after last dose of study medication.|All analyses were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.|||Subjects|||Number
2793846|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Adverse Event|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|First dose through 7 day follow up|All analyses of safety were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.|||Subjects|||Number
2793847|NCT00564486|Secondary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with 0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period."|Baseline to 24 hrs|Included modified Intent To Treat group (mITT), defined as randomized subjects who received at least one complete infusion of study medication prior to receiving rescue medication.|||Units on a scale||Standard Deviation|Mean
2793848|NCT00564486|Primary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with 100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period."|Baseline to 24 hrs|All efficacy analyses were conducted using the modified intent-to-treat (mITT) population, defined as those subjects who received at least one complete infusion of study medication prior to requesting rescue medication.Worst Observation Carried Forward (WOCF) imputation was applied after first rescue medication.|||Units on a scale||Standard Deviation|Mean
2793849|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters|Conjunctiva Concentration of Azithromycin and Moxifloxacin|Over 24 hours||||μg/g||Standard Deviation|Mean
2793850|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters||Up to 24 hours|||||||
2793851|NCT00564395|Primary|Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections|Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.|0-48 hours post-dose||||mmol*hr/L||Standard Deviation|Mean
2793852|NCT00564278|Secondary|Proportion of Fully Adherent Days|We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps [eCaps], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.|Measured at each visit, up to 36 weeks|All patients in both arms|||Proportion of Fully Adherent days||Standard Deviation|Mean
2793853|NCT00564278|Secondary|Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)|Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.|CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.|||units on a scale ranging from 8 to 32||Standard Deviation|Mean
2793854|NCT00564278|Primary|Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.|QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.|||percentage of maximum possible score||Standard Deviation|Mean
2793855|NCT00564278|Primary|Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)|Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.|SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.|||Units on a scale ranging from 0-10||Standard Deviation|Mean
2793856|NCT00564278|Primary|Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)|"Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below.~We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures."|HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|All patients enrolled in both arms with available data at assessment time points.|||units on a scale ranging from 0 to 35||Standard Deviation|Mean
2793857|NCT00564278|Primary|Number of Days in ADT (Retention)|A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 [week 0 to week 1] + 28 [week 8 to week 12]).|Measured at Months 3 and 9|Patients who signed consent and attended at least one medication visit.|||Days in treatment||Standard Deviation|Mean
2793858|NCT00564265|Primary|Number of Patients Who Survived|The outcomes were measured through follow-up visits of the patients to the out-patient clinic of our institution at 15 days, 1 month, 3 months, 6 months, 1 year, and after that, every year after the surgical treatment.|5 years|This is a consecutive sample of all patients operated on for GISTs in 3 hospitals during a period of 5 years. The period of 5 years was determined by the time that we count with inmunochemistry to confirm GISTs at our institutions, and that time would be the last 5 years. The Last Observation Carried Dorward (LOCF) was made in August 2008.|||Participants|||Number
2793859|NCT00564070|Other Pre-specified|Glucose Control Over Follow up|Percent of HbA1c as assessed by blood analysis. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage. This percentage of HbA1c was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of HbA1c for each arm throughout the course of the study.|Aggregate across 4,8,12 months|HbA1c as assessed by blood analysis|||percentage of glycosylated hemoglobin||Standard Error|Mean
2793860|NCT00564070|Other Pre-specified|Depression CGI|Clinical Global Impression scale as rated by blinded interviewer. The CGI is a scale from 1-7 with greater numbers meaning more severe depression. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.|Aggregate 4,8,12 months||||Units on the CGI scle||Standard Error|Mean
2793861|NCT00564070|Other Pre-specified|Depression MADRS Over Follow up|Independent (blind) assessor rating using the MADRS. This scale has a range of 0-60 with higher scores indicating greater depression severity. This depression score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall depression score for each arm throughout the course of the study.|Aggregate across 4,8,12 months||||Units on the MADRS scale||Standard Error|Mean
2793862|NCT00564070|Other Pre-specified|Percent Medication Adherence During Follow up|Electronic pill cap adherence which indicates a percentage of doses taken. This percentage of doses taken was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage of doses taken for each arm throughout the course of the study.|Aggregate across 4,8,12 months||||percentage of doses taken||Standard Error|Mean
2793863|NCT00564070|Other Pre-specified|Glucose Monitoring During Followup.|This is a percent with a possible range of 0-100 with higher scores indicating better adherence. One Touch Ultra meters (LifeScan, Inc.) for daily glucose control provided frequency of self-monitoring, which when divided by the individualized goals from the nurse visits and multiplied by 100, yielded a percentage adherence score. This percentage adherence score was averaged at 4, 8, and 12 months between all participants in each arm, and those values were then averaged to give an overall percentage adherence score for each arm throughout the course of the study.|Aggregate of months 4,8,12||||percentage of glucose monitoring goal||Standard Error|Mean
2793864|NCT00564070|Primary|Depression on the CGI at Acute Outcome|Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression|Month 4|Participants in each study arm|||units on a scale - the CGI||Standard Deviation|Mean
2793865|NCT00564070|Primary|Clinician Rated Depression (MADRS) at the Acute Timepoint|Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.|month 4|Participants in each arm|||units on a scale (MADRS)||Standard Deviation|Mean
2793866|NCT00564070|Primary|Percent Medication Adherence Via MEMS|This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence|month 4|Participants in each study arm|||Percentage of pills taken||Standard Deviation|Mean
2793867|NCT00564070|Secondary|Glucose Control|Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage.|Month 4|HbA1c as assessed by blood analysis|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2793868|NCT00564070|Primary|Glucose Monitoring Adherence at Acute Outcome|Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.|Measured at Month 4||||percentage of glucose monitoring goal||Standard Deviation|Mean
2793869|NCT00564018|Secondary|Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis|We assessed glycemic control via measurement of Hemoglobin A1c at each quarterly clinic visit after diagnosis of diabetes. Data on the 6 month time point are presented|6 months|Data is presented for each subject at each time for which there was a measure.|||percent||Standard Deviation|Mean
2793870|NCT00564018|Primary|C-peptide Area Under the Curve|We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis.|Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis|All subjects who completed 6 month mixed meal tolerance test (MMTT)s|||ng*hr/mL||Inter-Quartile Range|Median
2793871|NCT00563797|Secondary|Mean Percentage of Heavy Drinking Days by Smoking|The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo.|25 weeks||||percentage of Heavy Drinking Days||Standard Deviation|Mean
2794124|NCT00561652|Primary|Participant Adherence With Education + Exercise Visits|Number of participants completing at least 3 of 4 education + exercise visits|12 weeks||||participants|||Number
2793873|NCT00563797|Primary|Depression - Measured Using the HAMD Total Score|"The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients.~Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression)"|12 weeks||||units on a scale||Standard Deviation|Mean
2793874|NCT00563797|Primary|Number of Drinking Days|Measured with time line follow back measures|25 weeks||||days||Standard Deviation|Mean
2793875|NCT00563784|Secondary|Overall Survival and Disease Local Control Rate|"The Secondary Endpoints is Overall Survival (OS)and Disease Local Control (DLC)Rate. All patients will be followed up to evaluate Overall Survival and Disease Local Control by one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.~CT scan of the chest/upper abdomen, MRI of brain or CT, and/or PET scan images are recommended to confirm the recurrence.~Survival endpoints were estimated using the Kaplan-Meier method."|OS: From date of registration until the date of first documented death or lost to follow up, whichever came first, accessed up to 5 years. DLC: From date of registration until the date of first documented local disease recurrence, accessed up to 5 years.|There were 46 out of 48 patients completed treatment under the protocol and evaluable for data analysis. 2 patients cannot complete the treatment and off-study. 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain.|||percentage of participants|||Number
2793876|NCT00563784|Primary|Time To First Disease Progression|Primary Endpoints is efficacy of concurrent erlotinib and chemoradiation as measured by time to progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. All patients will be evaluated by followed up one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.|From date of registration until the date of first documented progression or death from any cause, or lost to follow up, whichever came first, assessed up to 5 years.|There were 46 out of 48 patients completed treatment under the protocol and evaluable for data analysis. 2 patients cannot complete the treatment and off-study. 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain.|||Month||95% Confidence Interval|Median
2793877|NCT00563706|Secondary|Calgary Depression Scale for Schizophrenia (CDSS) Score|CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793878|NCT00563706|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).|Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793879|NCT00563706|Secondary|Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793880|NCT00563706|Secondary|Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score|Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793881|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score|Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793882|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score|General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793883|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Negative Subscale Score|PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793884|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Positive Subscale Score|PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.||||||
2793885|NCT00563706|Primary|Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 28|mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2793886|NCT00563706|Primary|Positive and Negative Symptom Scale (PANSS) Total Score at Baseline|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.|||units on a scale||Standard Deviation|Mean
2793887|NCT00563576|Secondary|Percentage of Subjects Who Receive a 3rd Injection||6 months||||Participants|||Count of Participants
2793888|NCT00563576|Secondary|Number of Subjects Who Receive a 2nd Injection of Depo-Provera||3 months||||participants|||Number
2793889|NCT00563576|Secondary|Percentage of Users Who Were Satisfied With Femring|Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group.|3 months|Acceptability was reported among the 26 participants in the Femring group who were available for followup, i.e., per protocol.|||participants|||Number
2793890|NCT00563576|Primary|Mean Number of Bleeding or Spotting Days|Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information.|3 months||||days||Standard Deviation|Mean
2793891|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793892|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793893|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793894|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793895|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2794125|NCT00561652|Other Pre-specified|Participant Adherence With Chiropractic Visits|Number of participants who completed at least 12 chiropractic visits.|12 weeks||||participants|||Number
2793896|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793897|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793898|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793899|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793900|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793901|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793902|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793903|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793904|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793905|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793906|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples|||liter per minute (L/min)||Standard Error|Mean
2793907|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
2793908|NCT00563381|Secondary|COPD Exacerbations Treated With Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
2793909|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
2793910|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793911|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793912|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793913|NCT00563381|Secondary|First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First|First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793914|NCT00563381|Secondary|Number of Participants With Premature Discontinuation of Trial Medication||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Participants|||Number
2793915|NCT00563381|Secondary|Occurrence of Premature Discontinuation of Trial Medication|Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793916|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Participants|||Number
2793917|NCT00563381|Secondary|First Occurrence of COPD Exacerbation Leading to Hospitalization|First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793918|NCT00563381|Secondary|COPD Exacerbations Per Patient-year||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||exacerbations per patient-year||95% Confidence Interval|Mean
2793919|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Participants|||Number
2793920|NCT00563381|Secondary|COPD Exacerbations Per Patient-year Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||Hospitalizations per patient-year||95% Confidence Interval|Mean
2794126|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793921|NCT00563381|Primary|First Occurrence of (Moderate or Severe) COPD Exacerbation|First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment|||number of first occurrences|||Number
2793922|NCT00563368|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF||baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percentage of participants|||Number
2793923|NCT00563368|Primary|Percent Weight Loss From Baseline to Week 28|Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)|baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
2793924|NCT00563316|Primary|Number of Participants With Clinically Significant Adverse Events (AEs)|"Adverse events of special interest include infusion reactions, integument toxicities, diarrhea, stomatitis, hypomagnesemia, and pulmonary, vascular, and cardiac toxicities. Infusion reactions were defined as 1. Prespecified signs and symptoms indicating a possible infusion reaction (derived from Common Terminology Criteria for Adverse Events (CTCAE) definitions of allergic reaction/hypersensitivity and cytokine release syndrome/acute infusion reaction) with onset day coincident with any study drug infusion and which resolved the day of, or the day after, onset; 2. incidence of AE with terms consistent with the panitumumab US package insert (USPI) (any event within 24 hours of an infusion during the clinical study described as allergic reaction or anaphylactoid reaction, or any event occurring on the first day of dosing described as allergic reaction, anaphylactoid reaction, fever, chills, or dyspnea).~Data are summarized overall and by treatment phase."|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date, until the data cut-off date of 16 July 2009. The median time frame is 5.7 months.|All treated participants|||participants|||Number
2793925|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of the Last Quantifiable Concentration (AUClast) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUClast of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set|||hr*ng/mL||Standard Deviation|Mean
2793926|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUCinf) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUCinf of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set|||hr*ng/mL||Standard Deviation|Mean
2793927|NCT00563316|Primary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the Cmax of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured. Plasma samples were assayed by a validated high performance liquid chromatography (HPLC)-fluorescence method for the measurement of irinotecan. The lower limit of quantitation (LLOQ) was 2 ng/mL.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set included all participants who received panitumumab 6 mg/kg and irinotecan 180 mg/m² without dose reductions or delays and who completed the blood sample collection for pharmacokinetic analysis during cycles 1 and 2.|||ng/mL||Standard Deviation|Mean
2793928|NCT00563290|Secondary|COX-2 Presence by IHC|Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed.|At baseline|Funding was not available to do correlative studies||||||
2793929|NCT00563290|Secondary|Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)|Performed per standard protocols by the Pathology Department.|At baseline|Funding was not available to do correlative studies||||||
2793930|NCT00563290|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Time from start of treatment to time of progression, assessed up to 12 weeks|The second treatment arm of Dasatinib 70 mg orally twice a day was created as a result of an amendment to the protocol therefore the patient PFS data was combined for each arm.|||weeks||Full Range|Median
2793931|NCT00563290|Primary|Objective Response Rate (Complete Response and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment||||percentage of patients|||Number
2793932|NCT00563186|Post-Hoc|Event Incidence Density in Single vs Multi-bed Rooms in Novel Design Ward Only|The incidence density of MRSA, VRE and CDI occurring in single-bed vs. multi-bed rooms was examined on only the novel design ward|In-hospital|All patients that met the inclusion and exclusion categories and were admitted to the novel design ward were assessed for the development of MRSA, VRE or CDI. The incidence densities in single-bed rooms were then compared to the incidence densities in multiple-bed rooms.|||events per 1000 patient days|||Number
2793958|NCT00562588|Secondary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||participants|||Number
2793933|NCT00563186|Secondary|Number of MRSA, VRE and CDI Occurring in Single-bed Rooms vs. Multiple Bed Rooms AND Occurring in Outbreaks Related to the Primary Case|If a patient is swabbed and found to be positive (for MRSA or VRE), their current roommate\roommates will be swabbed (if in the same room > 48 hrs) as well as any other patient that shared a room with this patient for > 48 hours during this stay. Any patient who may have shared a bathroom with the first patient would also be swabbed. If the results from this investigation showed any positive roommates, then the process would repeat for each positive patient. Then, in consult with the infectious disease physician, a call will be made regarding a point prevalence study to determine the attack rate\burden of disease on the unit.|in-hospital|An outbreak occurred when more than 1 case of MRSA, VRE or CDI was epidemiologically linked to a primary case. In total 22 outbreak cases were detected during the study. The location of these outbreak cases (single-bed rooms vs. multi-bed rooms) was identified in the Novel Hospital Ward and the Traditional Hospital Ward|||outbeak infections/colonizations|Total Number of Outbreak cases||Number
2793934|NCT00563186|Primary|Incidence Density of Hospital-acquired Infection With Clostridium Difficile (CDI), and Hospital-acquired Infection or Colonization With Vancomycin-resistant Enterococcus (VRE), or Methicillin-resistant Staphylococcus Aureus (MRSA).||participants were followed for the duration of hospital stay, an average of 10 days|All patients meeting inclusion criteria, and admitted to the General Internal Medicine (GIM) service on the novel infection control design ward or the traditional infection control design ward were followed for the development of MRSA or VRE infection (inf) or colonization (col) or CDI after 48 hours of admission|||events per 1000 patient days|||Number
2793935|NCT00562965|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg).|Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)|Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).|||participants|||Number
2793936|NCT00562965|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings|Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]).|Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)|Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).|||participants|||Number
2793937|NCT00562965|Other Pre-specified|Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 42 days post-treatment|Safety population included all participants who received at least 1 dose of a test article (either rituximab + inotuzumab ozogamicin or control regimens R-CVP + R-FND).|||participants|||Number
2793938|NCT00562965|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings|Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment.|Baseline up to 42 days post-treatment|Safety population included all participants who received at least 1 dose of a test article. Here 'N' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2793939|NCT00562965|Secondary|Pharmacokinetics of Inotuzumab Ozogamicin in Combination With Rituximab||0, 1, 168 hours on Cycle 1, 2; 0, 1, 2, 168 hours on Cycle 3, 4|Data for this outcome measurement was not collected since pharmacokinetic parameters were not analyzed in this study due to very few number of participants with PK samples.||||||
2793940|NCT00562965|Secondary|Overall Survival Probability at Months 6, 12 and 24|Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function.|Baseline up to Month 6, 12, 24|Intent-to-treat population included all participants who were randomized in to the study.|||percent chance of survival||95% Confidence Interval|Number
2793959|NCT00562588|Secondary|Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)||90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||participants|||Number
2793960|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||Units on a scale||Inter-Quartile Range|Median
2794127|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793941|NCT00562965|Secondary|Percentage of Participants With Objective Response (OR)|OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia).|Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug|Intent-to-treat population included all participants who were randomized in to the study.|||percentage of participants||95% Confidence Interval|Number
2793942|NCT00562965|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44.|Baseline until disease progression or death or up to 1 year after last dose of study drug|Intent-to-treat population included all participants who were randomized in to the study.|||months||95% Confidence Interval|Median
2793943|NCT00562861|Primary|MADRS Rating Scale Change|Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.|6 weeks|All patients randomized were analyzed in intent to treat manner.|||units on a scale||Standard Deviation|Mean
2793944|NCT00562718|Secondary|Recurrence|This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy|1 year||||percentage of participants|||Number
2793945|NCT00562718|Secondary|Cosmesis||1 year||||participants|||Number
2793946|NCT00562718|Primary|Overall Safety|Primarily Grade 1 and 2 toxicities attributable to capecitabine|1 year|Radiation given based on planned- 50.4cGy|||percentage of participants|||Number
2793947|NCT00562627|Secondary|Time to Readiness for Discharge|Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.|up to 10 days postoperative||||days||Standard Deviation|Mean
2793948|NCT00562627|Primary|Pain at Rest (VAS)|VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.|48 hours postoperative||||Units on a scale||Standard Deviation|Mean
2793949|NCT00562627|Secondary|Opioid Use|Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.|48 hours postoperative||||mg||Standard Deviation|Mean
2793950|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 90.|||mL||Inter-Quartile Range|Median
2793951|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 8.|||mL||Inter-Quartile Range|Median
2793952|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 90.|||mL||Inter-Quartile Range|Median
2793953|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 8.|||mL||Inter-Quartile Range|Median
2793954|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value - MCP-1|Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||µg/mL||95% Confidence Interval|Geometric Mean
2793955|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- MMP-9|Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||ng/mL||95% Confidence Interval|Geometric Mean
2793956|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- CRP|Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||mg/L||95% Confidence Interval|Geometric Mean
2793957|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||units on a scale||Inter-Quartile Range|Median
2794128|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793961|NCT00562588|Primary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment)|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.|||participants|||Number
2793962|NCT00562484|Secondary|New Onsets of Chronic Illness (NOCI)|An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
2793963|NCT00562484|Secondary|Serious Adverse Events (SAEs)|"An SAE was any untoward medical occurrence that at any dose:~Resulted in death;~Was life-threatening;~Required an unexpected in-participant hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant disability / incapacity;~Was a congenital anomaly / birth defect; and / or~Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out"|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
2793964|NCT00562484|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|"UAE grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities."|21 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
2793965|NCT00562484|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms|"Adverse event grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities.~Fever Grade 1: ≥ 37.7°C - < 38.0°C (≥ 99.9 - < 100.4°F) Grade 2: ≥ 38.0°C - < 39.0°C (≥ 100.4 - < 102.2°F) Grade 3: ≥ 39.0°C (> 102.2°F)"|5 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL’s IVV or placebo) and provided at least one safety assessment after the vaccination.|||Participants|||Number
2793966|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Fold increase||95% Confidence Interval|Number
2793967|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Fold increase||95% Confidence Interval|Number
2793968|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
2793969|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
2793970|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
2793971|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants||95% Confidence Interval|Number
2794022|NCT00562302|Primary|Incidence Rate of Treatment Success|Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).|30 days|Per Protocol Population|||participants|||Number
2793972|NCT00562484|Secondary|Incidence of Influenza-like Illness (ILI)|"The criteria for the protocol defined ILI were as follows:~At least one respiratory symptom:~cough, sore throat or nasal congestion~And at least one systemic symptom:~fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches.~The CDC ILI case definition was the occurrence of fever (100°F [37.8°C] or higher) in conjunction with either cough or sore throat."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Percentage of participants|||Number
2793973|NCT00562484|Secondary|CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains|"Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.~Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Ratio||95% Confidence Interval|Number
2793974|NCT00562484|Primary|CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection|"Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.~Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.|||Ratio||95% Confidence Interval|Number
2793975|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2793976|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2793977|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2793978|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.|||percentage of participants|||Number
2793979|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
2793980|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
2793981|NCT00562354|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody concentration for the specified serotype. GMCs calculated using all participants with available data for the specified blood draw.|||mcg/mL||95% Confidence Interval|Geometric Mean
2793982|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
2793983|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
2793984|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793985|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793986|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793987|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793988|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2794129|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2793989|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793990|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793991|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793992|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2793993|NCT00562354|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody titers for the specified serotype. GMTs calculated using all participants with available data for the specified blood draw.|||titer||95% Confidence Interval|Geometric Mean
2793994|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
2793995|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.|||fold rise||95% Confidence Interval|Geometric Mean
2793996|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.|||titer||95% Confidence Interval|Geometric Mean
2794048|NCT00561951|Secondary|"The Number of Patients With Severe Problems, Score 5 or Many Severe Problems, Score 6 in Patient Perception of Bladder Condition (PPBC) at Week 12."|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:~No problems at all~Some very minor problems~Some minor problems~Some moderate problems~Severe problems~Many severe problems"|Baseline to Week 12|Full analysis set. No imputation was used for missing data|||participants|||Number
2793997|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.|||titer||95% Confidence Interval|Geometric Mean
2793998|NCT00562328|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 5 years)||||months||95% Confidence Interval|Median
2793999|NCT00562328|Secondary|Time to Next Treatment|Time to next treatment was defined as the time from end of active (protocol) treatment to the start of subsequent treatment. The median and 95% CI was estimated using the Kaplan Meier method.|time from end of protocol treatment to subsequent treatment (up to 5 years)||||months||95% Confidence Interval|Median
2794000|NCT00562328|Secondary|Duration of Response|"Duration of response (DOR) is defined as the time from documentation of response (CR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method.Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months:~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|time from start of response to progression (up to 5 years)|Only patients who responded to treatment are included in this analysis.|||months||95% Confidence Interval|Median
2794001|NCT00562328|Secondary|Progression Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to the standard NCI-WG96 criteria. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from registration to progression (up to 5 years)||||months||95% Confidence Interval|Median
2794002|NCT00562328|Primary|Number of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months|"Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months:~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months||||Participants|||Count of Participants
2794003|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]~Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed~Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.|||percentage of true tests||95% Confidence Interval|Number
2794004|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)~Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed~Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.|||percentage of true tests||95% Confidence Interval|Number
2794023|NCT00562159|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS|The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Deviation|Mean
2794005|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)~Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed~Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.|||percentage of true tests||95% Confidence Interval|Number
2794006|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]~Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed~Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.|||percentage of true tests||95% Confidence Interval|Number
2794007|NCT00562315|Primary|Number of Participants With False Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
2794008|NCT00562315|Primary|Number of Participants With False Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
2794009|NCT00562315|Primary|Number of Participants With True Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
2794010|NCT00562315|Primary|Number of Participants With True Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.|||participants|||Number
2794011|NCT00562315|Primary|Number of Participants With False Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
2794012|NCT00562315|Primary|Number of Participants With True Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
2794013|NCT00562315|Primary|Number of Participants With False Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
2794014|NCT00562315|Primary|Number of Participants With True Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.|||participants|||Number
2794015|NCT00562302|Secondary|Incidence of Adverse Events|Any treatment emergent adverse events (not considered device related by the investigators).|30 days|Intent to Treat Population|||participants|||Number
2794016|NCT00562302|Secondary|Participants Discharged Beyond Hospital's Standard of Care|Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital's standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.|30-day|Intent to Treat Population|||participants|||Number
2794017|NCT00562302|Secondary|Number of Participants With Additional Chest X-rays Needed||30 day|Intent to Treat Population|||participants|||Number
2794018|NCT00562302|Secondary|Incidence of Adverse Events Related to the Procedure and Device Effects|Anticipated, device-related adverse events that were defined in the original protocol.|30 Day|Intent to Treat Patients|||participants|||Number
2794019|NCT00562302|Secondary|Incidence of Hospital Admissions for Pneumothorax||30 day|Intent to treat Population|||participants|||Number
2794020|NCT00562302|Secondary|Time to Ambulation||30 days|Intent to Treat Population|||Hours||Standard Deviation|Mean
2794021|NCT00562302|Secondary|Incidence of Chest Tube Placement|A chest tube is the definitive initial treatment of a pneumothorax.|30 days|Intent to treat Population|||participants|||Number
2794024|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
2794025|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
2794026|NCT00562159|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication.|Start of the GPS to End of the GPS|The full analysis set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
2794027|NCT00562120|Other Pre-specified|Serum PF-03654746 Concentration|Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.|1 hr 30 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2794028|NCT00562120|Secondary|Nasal Symptom Scores: Sneezing|The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where 'post-diluent, pre-allergen challenge' included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and 'post-allergen challenge' included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||sneezes||Standard Deviation|Mean
2794029|NCT00562120|Secondary|Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea|Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for 'post-diluent, pre-allergen challenge' measure and 'post-challenge' measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||units on a scale||Standard Deviation|Mean
2794030|NCT00562120|Secondary|Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest 'post-allergen challenge' nasal volume measurement among the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||cubic centimeter (cm^3)||Standard Deviation|Mean
2794046|NCT00561977|Primary|Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).|The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0-10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).|3 months||||score||Standard Deviation|Mean
2794047|NCT00561977|Primary|Dietary Quality|Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).|6 mos||||score||Standard Deviation|Mean
2794099|NCT00561795|Secondary|18-week Progression Free Survival|Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.|Baseline to Week 18||||participants|||Number
2794031|NCT00562120|Secondary|Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest 'post-allergen challenge' Amin measurement of the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||square centimeter (cm^2)||Standard Deviation|Mean
2794032|NCT00562120|Primary|Nasal Volume Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||ratio||Standard Deviation|Mean
2794033|NCT00562120|Primary|Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.|||ratio||Standard Deviation|Mean
2794034|NCT00562094|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
2794035|NCT00562094|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
2794036|NCT00562094|Secondary|Assessment of the Severity of Sensation of Fullness/Abdominal Distension|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2794037|NCT00562094|Secondary|Assessment of the Severity of Epigastric Complaints/Epigastric Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2794038|NCT00562094|Secondary|Assessment of the Severity of Eructation/Acid Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2794039|NCT00562094|Secondary|Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
2794040|NCT00562094|Primary|Assessment of Change of Quality of Sleep During Therapy With Pantoprazole|"Physician's assessment on a scale with~considerably improved~improved~unchanged"|last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed|||percentage of participants|||Number
2794041|NCT00562094|Primary|Assessment of the Severity of Sleep Disturbances|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed|||percentage of participants|||Number
2794042|NCT00561977|Secondary|Change in Calories From Baseline to 6 Months|kilocalories|6 months||||calories||Standard Deviation|Mean
2794043|NCT00561977|Secondary|Change in Calories From Baseline to 3 Months|kilocalories|3 months||||calories||Standard Deviation|Mean
2794044|NCT00561977|Secondary|Change in Weight From Baseline to 6 Months||6 months||||pounds||Standard Deviation|Mean
2794045|NCT00561977|Secondary|Change in Weight From Baseline to 3 Months||3 months||||pounds||Standard Deviation|Mean
2794049|NCT00561951|Secondary|Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:~No problems at all~Some very minor problems~Some minor problems~Some moderate problems~Severe problems~Many severe problems~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. No imputation was used for missing data.|||score on scale||Standard Deviation|Mean
2794050|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.|"The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).~The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)|||score on scale||Standard Deviation|Mean
2794051|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).|"King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week12|Full analysis set. No imputation was used for missing data.|||score on scale||Standard Deviation|Mean
2794052|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||mL||Standard Deviation|Mean
2794053|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||mL||Standard Deviation|Mean
2794054|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|"Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.~No imputation was used for missing data."|||Night-Time Micturitions||Standard Deviation|Mean
2794055|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|"Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .~Last observation carried forward."|||Night-Time Micturitions||95% Confidence Interval|Least Squares Mean
2794056|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Incontinence is the complaint of any involuntary leakage of urine.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||Incontinence Episodes||Standard Deviation|Mean
2794057|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Incontinence is the complaint of any involuntary leakage of urine.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward|||Incontinence Episodes||95% Confidence Interval|Least Squares Mean
2794058|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||Urgency Episodes||Standard Deviation|Mean
2794059|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||Urgency Episodes||95% Confidence Interval|Least Squares Mean
2794060|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||Micturitions||Standard Deviation|Mean
2794061|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||Micturitions||95% Confidence Interval|Least Squares Mean
2794100|NCT00561795|Secondary|Cancer Antigen (CA-125) Response|Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.|Baseline until response (up to 2 years)||||participants|||Number
2794062|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.|||UUI Episodes||Standard Deviation|Mean
2794063|NCT00561951|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|"Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.|||UUI Episodes||95% Confidence Interval|Least Squares Mean
2794064|NCT00561925|Secondary|Occurrence of Hepatic Events|Frequency of patients with hepatitis symptoms|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
2794065|NCT00561925|Secondary|Relative Bioavailability Trough C_pre,ss,1|Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.|week 132|Only patients with trough drawn PK time window (12+/-2.5 hr for IR; 24+/-5hr for XR) at week 132 are included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2794066|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
2794067|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
2794068|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
2794069|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose|||cumulative probability|||Number
2794070|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||cumulative probability|||Number
2794071|NCT00561925|Secondary|Occurrence of Elevations in Laboratory Measurement by DAIDS Grade||until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
2794072|NCT00561925|Secondary|Occurrence of Rashes|Frequency of patients with drug related rash events by functional grouping|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
2794073|NCT00561925|Secondary|Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases|||cells/cubic millimeter||Standard Deviation|Mean
2794074|NCT00561925|Secondary|Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases|||log10 copies/mL||Standard Deviation|Mean
2794075|NCT00561925|Secondary|Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||proportion of participants|||Number
2794076|NCT00561925|Secondary|Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
2794077|NCT00561925|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||proportion of participants|||Number
2794078|NCT00561925|Primary|Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication|||participants|||Number
2794079|NCT00561912|Primary|Progression-free Survival (PFS) Times|Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.|From treatment start or until disease progression or death for any reason, at least 16 weeks|With one of the two participants ruled ineligible and inevaluable, there was insufficient data for statistical evaluation.|||Weeks|||Number
2794080|NCT00561834|Primary|Change in Visual Acuity|The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.|Baseline and 6 months||||lines change in Snellen chart|||Number
2794081|NCT00561821|Secondary|Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period|An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.|||Number of participants|||Number
2794082|NCT00561821|Secondary|Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.|||Number of participants|||Number
2794083|NCT00561821|Secondary|Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary|Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Units on a Scale||Standard Deviation|Mean
2794084|NCT00561821|Secondary|Average Subjective Quality of Sleep Based on Sleep Diary|Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Units on a Scale||Standard Deviation|Mean
2794085|NCT00561821|Secondary|Average Subjective Wake Time After Sleep Onset Based on Sleep Diary|Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794086|NCT00561821|Secondary|Average Subjective Number of Awakenings Based on Sleep Diary|Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Number of Awakenings||Standard Deviation|Mean
2794087|NCT00561821|Secondary|Average Subjective Sleep Latency Based on Sleep Diary|Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794088|NCT00561821|Secondary|Average Subjective Total Sleep Time Based on Sleep Diary|Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794089|NCT00561821|Secondary|Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography|Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Number of stage shifts||Standard Deviation|Mean
2794130|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2794090|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794091|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794092|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794093|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794094|NCT00561821|Secondary|Average Number of Awakenings Measured by Polysomnography|Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Number of awakenings||Standard Deviation|Mean
2794095|NCT00561821|Secondary|Average Total Sleep Time Measured by Polysomnography|Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794096|NCT00561821|Secondary|Average Latency to Persistent Sleep Measured by Polysomnography|Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794097|NCT00561821|Primary|Average Wake Time After Sleep Onset Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The intent to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.|||Minutes||Standard Deviation|Mean
2794098|NCT00561795|Primary|Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events|"Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the Adverse Event section of the results record for additional details and data."|Baseline to End of Study (up to a year)||||participants|||Number
2794101|NCT00561795|Secondary|Overall Response|Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|Baseline until either response or progression (up to 2 years)||||participants|||Number
2794102|NCT00561730|Secondary|Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Percentage of participants|||Number
2794103|NCT00561730|Secondary|Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Percentage of participants|||Number
2794104|NCT00561730|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2794105|NCT00561730|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2794106|NCT00561730|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
2794107|NCT00561730|Primary|Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1755~Day 1 = 1740~Day 2 = 1740~Day 3 = 1733~Day 4 = 1732~Day 5 = 1725~Day 6 = 1727"|||Units on a scale||Standard Deviation|Mean
2794108|NCT00561730|Primary|Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1755~Day 1 = 1744~Day 2 = 1742~Day 3 = 1728~Day 4 = 1727~Day 5 = 1724~Day 6 = 1726"|||Units on a scale||Standard Deviation|Mean
2794109|NCT00561730|Primary|Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1754~Day 1 = 1742~Day 2 = 1739~Day 3 = 1733~Day 4 = 1730~Day 5 = 1726~Day 6 = 1729"|||Units on a scale||Standard Deviation|Mean
2794110|NCT00561730|Primary|Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1760~Day 1 = 1750~Day 2 = 1746~Day 3 = 1735~Day 4 = 1735~Day 5 = 1730~Day 6 = 1734"|||Units on a scale||Standard Deviation|Mean
2794111|NCT00561730|Primary|Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1767~Day 1 = 1758~Day 2 = 1757~Day 3 = 1744~Day 4 = 1743~Day 5 = 1739~Day 6 = 1739"|||Units on a scale||Standard Deviation|Mean
2794112|NCT00561730|Primary|Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1769~Day 1 = 1760~Day 2 = 1761~Day 3 = 1751~Day 4 = 1749~Day 5 = 1742~Day 6 = 1747"|||Units on a scale||Standard Deviation|Mean
2794113|NCT00561678|Secondary|Length of Stay|Length of Stay (LOS) in the hospital|average 4 days||||days||Inter-Quartile Range|Median
2794114|NCT00561678|Secondary|Intraoperative Hypertension|Number of participants with intraoperative hypertension|day 1||||Participants|||Count of Participants
2794115|NCT00561678|Secondary|Intraoperative Hypotension|Number of participants with intraoperative hypotension|day 1||||Participants|||Count of Participants
2794116|NCT00561678|Secondary|Intraoperative Bradycardia|Number of participants with intraoperative bradycardia|day 1||||Participants|||Count of Participants
2794117|NCT00561678|Secondary|Neuropsychological Testing|Rate of change of cognitive function - data not collected because secondary analysis which was not performed|at 3 months postoperatively|||||||
2794118|NCT00561678|Primary|Delirium Battery|Number of Participants with occurrence of Post-Operative Delirium in Post-Anesthesia Care Unit (PACU)|Day 1||||Participants|||Count of Participants
2794119|NCT00561652|Other Pre-specified|Participant Adherence With Week 26 Follow-up Questionnaire|Number of participants who completed week 26 follow-up questionnaire|26 weeks||||participants|||Number
2794120|NCT00561652|Other Pre-specified|Participant Adherence With Week 12 Follow-up Questionnaire|Number of participants who completed their week 12 follow-up questionnaire|12 weeks||||participants|||Number
2794121|NCT00561652|Other Pre-specified|Participant Adherence With Week 6 Follow-up Questionnaire|Number of participants who completed their week 6 follow-up questionnaire|6 weeks||||participants|||Number
2794122|NCT00561652|Other Pre-specified|Participant Adherence With Prescribed Home Exercise|Number of participants who completed at least 20 hours of home exercise|12 weeks||||participants|||Number
2794131|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2794148|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2794149|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.|||ug/L||Full Range|Median
2794150|NCT00561600|Secondary|Harris Hip Function Score at 24 Months|Mean Harris Hip Function sub score at 24 months|24 months||||units on a scale 0-47. 47 is best||Standard Deviation|Mean
2794151|NCT00561600|Secondary|Harris Hip Pain Sub Score at 24 Months|Mean Harris Hip Pain sub score|24 months||||units on scale of 0-44. 44 is best||Standard Deviation|Mean
2794152|NCT00561600|Secondary|T-Test of Harris Hip Total Score Means at 24 Months|T-Test of Harris Hip total score means at 24 months|24 months||||Units on a scale of 0-100,100 is best.||Standard Deviation|Mean
2794153|NCT00561600|Primary|Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes|"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"|24-month interval.|Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).|||participants|||Number
2794154|NCT00561574|Secondary|Change From Baseline in Number of Awakenings (NAW)|"NAW was defined as the time recorded by participants in response to Weekly Sleep Diary question 2a During the past 7 nights, how many times did you wake up, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline NAW assessment.|||Number of Awakenings||Standard Deviation|Mean
2794155|NCT00561574|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how long did it take you to fall asleep, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline SL assessment.|||Minutes||Standard Deviation|Mean
2794156|NCT00561574|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time were you awake, on average, after falling asleep initially? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline WASO assessment.|||Minutes||Standard Deviation|Mean
2794157|NCT00561574|Secondary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time did you actually spend sleeping, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a last observation carried forward (LOCF) approach."|Baseline and Week 52|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had at least one postbaseline TST assessment.|||Minutes||Standard Deviation|Mean
2794158|NCT00561574|Primary|Change From Baseline in Total Nap Time|"Total nap time was assessed by participants in response to Weekly Sleep Diary question 9a How much time per day did you nap, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Minutes||Standard Deviation|Mean
2794159|NCT00561574|Primary|Change From Baseline in Ability to Work/Function|"Ability to work/function was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 8 How were you able to work or function over the past 7 days?. Scores could range from 0=Not at all to 100=Very well. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Score on a Scale||Standard Deviation|Mean
2794160|NCT00561574|Primary|Change From Baseline in Feeling Full of Energy|"Feeling full of energy was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 7 How full of energy have you felt over the past 7 days?. Scores could range from 0=Terribly tired to 100=Full of energy. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Score on a Scale||Standard Deviation|Mean
2794161|NCT00561574|Primary|Change From Baseline in Alertness at Awakening|"Alertness at awakening was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 6 How did you feel upon awakening over the past 7 days?. Scores could range from 0=Tired to 100=Alert. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an observed cases (OC) approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.|||Score on a Scale||Standard Deviation|Mean
2794162|NCT00561574|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 52 weeks|The AST population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2794163|NCT00561574|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 53 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2794164|NCT00561470|Secondary|Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.|Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo|Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.|||participants|||Number
2794165|NCT00561470|Secondary|Number of Participants With Adverse Events (AE)|"All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.~The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported."|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).|||participants|||Number
2794166|NCT00561470|Secondary|Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0.~CR reflected the disappearance of all tumor lesions (with no new tumors)~PR reflected a pre-defined reduction in tumor burden~Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks."|From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)|The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.|||percentage of participants||95% Confidence Interval|Number
2794167|NCT00561470|Secondary|Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)|"PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.~PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.~The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred."|From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)|Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.|||months|Participants|Inter-Quartile Range|Median
2794168|NCT00561470|Primary|Overall Survival (OS)|"Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).~OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model."|From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized.|||months|Participants|Inter-Quartile Range|Median
2794169|NCT00561457|Primary|Rate of Major Adverse Clinical Events (MACE)|Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure.|9-months|The analysis was an intention to treat (ITT)population which included the data for all completed patients (those who had a MACE event within 9-months and those who reached 9 months without experiencing an event). Natural censoring was used in the analysis according to the statistical analysis plan.|||MACE events per 9 months||95% Confidence Interval|Mean
2794170|NCT00561431|Secondary|Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT|The number of participants who recover renal function at 30 days after enrollment in each arm.|Up to 30 days|intention to treat|||Participants|||Number
2794171|NCT00561431|Primary|Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.|Up to 30 days|Intention to treat|||participants|||Number
2794172|NCT00561418|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 3 years|Unable to calculate time to progression for patients due to not enough follow up time||||||
2794173|NCT00561418|Secondary|Duration of Response|Median follow up of living patients|Up to 5 years||||months||Full Range|Median
2794174|NCT00561418|Secondary|Clinical Benefit|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|Response following AHSCT|||patients|||Number
2794175|NCT00561418|Primary|Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation|NCI CTCAE version 3.0 was used to assess Adverse Events (AE) Grade 1=Mild AE Grade 2=Moderate AE Grade 3=Severe AE Grade 4=Life-threatening or disabling AE|Up to 3 years||||patients|||Number
2794927|NCT00556933|Secondary|Safety Profile|Number of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles.|Two years||||Events|Participants||Number
2794176|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. A negative change score indicates reduced burden.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Units on a scale||Standard Deviation|Mean
2794177|NCT00561392|Primary|Percentage of Participants Who Were Compliant to the 10 cm^2 Patch|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Percentage of participants||Standard Deviation|Mean
2794178|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Percentage of participants||95% Confidence Interval|Number
2794179|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.|Baseline t0 Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Participants|||Number
2794180|NCT00561392|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Participants|||Number
2794181|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24|The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.|||Units on a scale||Standard Deviation|Mean
2794182|NCT00561392|Secondary|Mean Change From Baseline in the Trail-making Test Part A Score at Week 24|The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Seconds||Standard Deviation|Mean
2794183|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Units on a scale||Standard Deviation|Mean
2794184|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.|||Percentage of participants||95% Confidence Interval|Number
2794213|NCT00561340|Primary|Height Change|Change in height from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.|||centimeters||Standard Deviation|Mean
2794185|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-experienced HCV-infected participants considered non-responders (participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV ribonucleic acid (RNA) levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up at selected time points following treatment with TMC435 coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right was 8, 7, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng.h/mL||Standard Deviation|Mean
2794186|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-naïve HCV-infected participants administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng.h/mL||Standard Deviation|Mean
2794187|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of Css,av for TMC435 in treatment-experienced HCV-infected participants (non-responders and relapsers, see defined above) at selected time points following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/ml||Standard Deviation|Mean
2794188|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation)of Css,av for TMC435 in treatment-naïve HCV-infected participants at selected time points administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Day 7 (predose); Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel A, Cohorts 1 and 2) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel B, Cohorts 1 and 2)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/ml||Standard Deviation|Mean
2794189|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of C0h for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 2 and Day 28 differed as follows: At Day 2, the number of participants in the 4 treatment groups (from left to right) were 8, 7, 10, and 5; the number of participants analyzed at Day 28 in the 4 treatment groups (from left to right) were 9, 8, 10, and 4.|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/mL||Standard Deviation|Mean
2794190|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation) of C0h of TMC435 at selected time points following treatment with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) or with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B) in treatment-naïve participants (see treatment-naïve defined above).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 9, 8, 9, 9, and 10."|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/ml||Standard Deviation|Mean
2795502|NCT00553319|Primary|ADHD Symptoms Based on ADHD Rating Scale|The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0|measured once per week for 14 weeks or length of study participation||||participants|||Number
2794191|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the mean (standard deviation) Cmax for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right were 8, 8, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/mL||Standard Deviation|Mean
2794192|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows the mean (standard deviation) Cmax for treatment-naïve participants at selected time points who were treated with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.|||ng/mL||Standard Deviation|Mean
2794193|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) in each treatment group in Cohort 4, Panel C and in Cohort 5, Panel D with an SVR to treatment defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of the entire treatment regimen. SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively).|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794194|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with an SVR to treatment (defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively). See treatment-naïve defined above."|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794195|NCT00561353|Secondary|Viral Relapse in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants combined (non-responders and relapsers, see defined above) with viral relapse, defined as having confirmed detectable plasma level of HCV ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment who received TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-experienced and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|||Participants|||Number
2794196|NCT00561353|Secondary|Viral Relapse in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with viral relapse (defined as having confirmed detectable plasma level of HCV ribonucleic acid [RNA] during the follow-up period in participants with undetectable plasma HCV RNA [less than 25 IU/mL undetectable] at the end of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). See treatment-naïve defined above."|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-naïve and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|||Participants|||Number
2794197|NCT00561353|Secondary|Viral Breakthrough in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794214|NCT00561340|Primary|Weight Change|Change in weight observed from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.|||kilograms||Standard Deviation|Mean
2794215|NCT00561145|Secondary|Expression of Genes Involved in Energy Metabolism||Before and after the energy restriction period.|||||||
2794216|NCT00561145|Secondary|Resting Energy Expenditure, Body Composition and Body Weight||Before and after the energy restriction period|||||||
2794198|NCT00561353|Secondary|Viral Breakthrough in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1, Panel A and B)|The table below shows the number of treatment-naïve participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached, or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) after treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on days 8, 15, and 22 (Panel A) and after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses. Note: Number of participants analyzed during the PegIFNα-2a and ribavirin treatment period of up to 44 weeks is N=16 for TMC435 25 mg, N=17 for TMC435 75 mg, and N=17 for TMC435 200 mg.|||Participants|||Number
2794199|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with an initial suboptimal response defined as less than 2 log10 change of plasma in plasma level of HCV ribonucleic acid (RNA) at Day 2 or 3 (depending when visit was scheduled) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794200|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat (ITT) population, defined as all participants who were randomized and received at least one dose of study medication (TMC435) was used for all analyses.|||Participants|||Number
2794201|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794202|NCT00561353|Secondary|Virologic Response Parameters Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12; a complete EVR (cEVR) defined as a EVR having undetectable plasma HCV RNA at Week 12; an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794203|NCT00561353|Secondary|Virologic Response Parameters in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|The table below shows the number of treatment-naïve participants in the treatment groups for Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined) who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12); a complete EVR (cEVR) defined as a complete EVR having undetectable plasma HCV RNA at Week 12); an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794204|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. Note: in the table below, the number of participants (n) analyzed in the TMC435 200 mg (Cohort 4, Panel B) on Day 28 (Week 4) was n=4.|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794217|NCT00561145|Secondary|Gastrointestinal Function||Before and after the energy restriction period|||||||
2794205|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naive HCV-Infected participants with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794206|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve HCV-infected participants treated with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 who had the following virologic responses: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Participants|||Number
2794207|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2794208|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2794209|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2794210|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2794211|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2794212|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo as for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
2794219|NCT00561145|Primary|Energy Intake Compensation|"To assess energy intake compensation, we will assess average energy intake during the ad libitum food intake phase - which is the period after energy restriction- in young men and compare this to average energy intake in older men.~Average energy intake is assessed by measuring total megajoule of energy intake during nine days of the ad lib phase, and then divide it by nine (MJ/day)"|Average intake of energy during ad lib phase (9 days)|completed (see publication)|||MJ/day||Standard Deviation|Mean
2794220|NCT00561080|Secondary|Percentage of Participants Who Died During the Study|The number of participants who died for any reason during the study was summarized.|up to end of study (approximately 15 months)|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794221|NCT00561080|Secondary|Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE during the entire study period that was considered at least possibly -related to the vaccine were recorded."|up to end of study (approximately 15 months)|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794222|NCT00561080|Secondary|Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded."|up to 28 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794223|NCT00561080|Secondary|Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE within 28 days of 1st dose of vaccine were recorded."|up to 28 days after 1st vaccination|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794224|NCT00561080|Secondary|Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized,|up to 28 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794225|NCT00561080|Secondary|Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) and were reported as at least possibly related to the vaccine were summarized|up to 28 days after 1st vaccination|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
2794226|NCT00561080|Secondary|Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized,|up to 28 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794227|NCT00561080|Secondary|Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized|up to 28 days after 1st vaccination|All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
2794228|NCT00561080|Secondary|Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2|Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded.|up to 28 days post-dose 2|All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2.|||Percentage of Participants|||Number
2794229|NCT00561080|Secondary|Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1|Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded.|up to 28 days post-dose 1|All randomized participants in Groups 1, 2 and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1.|||Percentage of Participants|||Number
2794230|NCT00561080|Secondary|Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2|Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded.|up to 28 days post-dose 2|All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2.|||Percentage of Participants|||Number
2794623|NCT00558519|Other Pre-specified|Outcomes of Patients Treated on This Study According to Pretreatment Characteristics Such as Age, Gender, White Blood Cell Count, Other Hematologic Parameters, Blood Chemistry, Immunophenotype, Cytogenetics and Molecular Genetic Characteristics||Up to 10 years post-registration|||||||
2794231|NCT00561080|Secondary|Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1|Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded.|up to 28 days post-dose 1|All randomized participants in Groups 1, 2, and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1.|||Percentage of Participants|||Number
2794232|NCT00561080|Secondary|Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2|The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded.|up to 28 days post-dose 2|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
2794233|NCT00561080|Secondary|Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1|The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded.|up to 28 days after 1st of study drug|All randomized participants in Groups 1, 2, and 3 who received at least 1 dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
2794234|NCT00561080|Secondary|Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2|Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain|up to 4 days after 2nd vaccination|All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.|||Percentage of Participants|||Number
2794235|NCT00561080|Secondary|Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1|Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain|up to 4 days after 1st vaccination|All randomized participants in Groups 1, 2 and 3 who received the 1st dose of study drug and had follow-up safety data. .|||Percentage of Participants|||Number
2794236|NCT00561080|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3|Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT.|Predose 1 and 24 and 36 months post-last dose|Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained.||||||
2794237|NCT00561080|Secondary|Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3|Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.|24 and 36 months post-last dose|Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained.||||||
2794238|NCT00561080|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3|Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT.|predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)|All randomized participants who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794239|NCT00561080|Secondary|Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose|Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.|1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)|All randomized participants in who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794240|NCT00561080|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3|Blood sample taken at predose (Day 0) and 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The GMFR was calculated following each vaccination as GMT Post-dose/GMT Pre-vaccination|Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)|All randomized participants in who received at least 1 dose of the study vaccine, had pre-dose 1 evaluation and had post-vaccination immunogenicity evaluation. Excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794241|NCT00561080|Secondary|Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1|Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA.|4 weeks post-dose (Month 1)|All randomized participants in Group 1 who received study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794253|NCT00561015|Primary|Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1|The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||hr||Full Range|Median
2794242|NCT00561080|Primary|Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3|Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).|4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)|All randomized participants in Groups 2 and 3 who received at least 1 dose of the study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794243|NCT00561015|Secondary|Percentage of Participants Who Achieved Sustained Virological Response (SVR)|The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Week 12, 24 after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||percentage of participants|||Number
2794244|NCT00561015|Secondary|Percentage of Participants Who Demonstrated Virological Relapse|Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|24 weeks after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||percentage of participants|||Number
2794245|NCT00561015|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline, Day 12, 15 and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||percentage of participants|||Number
2794246|NCT00561015|Secondary|Median Time to Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline up to EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||days||Full Range|Median
2794247|NCT00561015|Secondary|Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).|Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points.|||percentage of participants|||Number
2794248|NCT00561015|Primary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng*hr/ml||Standard Deviation|Mean
2794249|NCT00561015|Secondary|Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15|The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2794250|NCT00561015|Secondary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15|The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2794251|NCT00561015|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26|Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||log10 IU/ml||Full Range|Median
2794252|NCT00561015|Secondary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng*hr/ml||Standard Deviation|Mean
2794624|NCT00558519|Other Pre-specified|Analysis and Description of the Outcomes of Patients Treated on This Study According to Baseline Psychosocial Characteristics, Demographics, and Family Support||Up to 10 years post-registration|||||||
2794254|NCT00561015|Primary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1|The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2794255|NCT00561015|Primary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15|Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline, Pre-dose (Day 15)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo.|||log10 IU/ml||Full Range|Median
2794256|NCT00561002|Other Pre-specified|Seroconversion Rates for Each Influenza Antigen Post-Vaccination|Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.|Day 14 post-vaccination|The seroconversion analysis were on the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2794257|NCT00561002|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.|Day 14 post-vaccination|The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2794258|NCT00561002|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination||Day 0 and Day 14 after last dose of Fluzone|The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
2794259|NCT00561002|Primary|Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation|Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.|Days 0-3 post-dose|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2794260|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794261|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794262|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794263|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794264|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8|"Blood drawn at Day 1 and Day 30 of the~extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794265|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B|"Blood drawn at Day 1 and Day 30 of the~extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794266|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794267|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2794268|NCT00560937|Secondary|Mean Score on the Positive and Negative Symptom Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.|Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
2794269|NCT00560937|Secondary|Clinical Global Impression Scale (CGI-I)|The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms.|CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
2794270|NCT00560937|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.|Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
2794271|NCT00560937|Primary|Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.|Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
2794272|NCT00560937|Secondary|Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27.|Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)||||units on a scale||Standard Deviation|Mean
2794273|NCT00560937|Primary|Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048|The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).|SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|Pilot proof of concept study|||units on a scale||Standard Deviation|Mean
2794274|NCT00560885|Secondary|Composite 6-month Post-procedure Major Adverse Event Rate.||6 Months Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.|||percentage of subjects||95% Confidence Interval|Number
2794275|NCT00560885|Secondary|Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Secondary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.|||percentage of subjects||95% Confidence Interval|Number
2794276|NCT00560885|Primary|Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.|30 days Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.|||percentage of subjects||95% Confidence Interval|Number
2794277|NCT00560885|Primary|Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.|||percentage of subjects||95% Confidence Interval|Number
2794278|NCT00560859|Secondary|Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale|Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.|7 months following baseline.|There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module|||units on a scale||Standard Deviation|Mean
2794279|NCT00560859|Secondary|Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months|The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.|7 months following the baseline visit.||||Events per hour||Inter-Quartile Range|Median
2794280|NCT00560859|Primary|Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.|The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.|The primary endpoint measure will occur at 7 months following the baseline visit.||||units on a scale||Standard Deviation|Mean
2794291|NCT00560794|Secondary|Serum Cytokine Peak Levels in Cycle 1|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL.|Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days.|Safety analysis set|||pg/mL||Standard Deviation|Mean
2794292|NCT00560794|Secondary|Change From Screening Value in T-cell Count During Cycle 1|T-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.|||cells/μL||Standard Deviation|Mean
2794281|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||score on a scale||Standard Deviation|Mean
2794282|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||score on a scale||Standard Deviation|Mean
2794283|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||number of events||Standard Deviation|Mean
2794284|NCT00560833|Secondary|Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants receiving study drug with diary compliance adequate for this measure.|||Score on a scale||Standard Deviation|Mean
2794285|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The intent-to-treat (ITT) population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.|||Number of events||Standard Deviation|Mean
2794286|NCT00560794|Secondary|Terminal Half-life of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||hours||Standard Deviation|Mean
2794287|NCT00560794|Secondary|Clearance of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||L/hr/m²||Standard Deviation|Mean
2794288|NCT00560794|Secondary|Apparent Volume of Distribution||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||L/m²||Standard Deviation|Mean
2794289|NCT00560794|Secondary|Area Under the Drug Concentration-time Curve From Time Zero to Infinity||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||hr*ng/mL||Standard Deviation|Mean
2794290|NCT00560794|Secondary|Serum Blinatumomab Concentration at Steady State|The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL.|Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.|||pg/mL||Standard Deviation|Mean
2794293|NCT00560794|Secondary|Change From Screening Value in B-cell Count During Cycle 1|B-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.|||cells/μL||Standard Deviation|Mean
2794294|NCT00560794|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs."|From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.|Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab.|||participants|||Number
2794295|NCT00560794|Secondary|Time to MRD Relapse|"Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring.~MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days|Full analysis set|||days||95% Confidence Interval|Median
2794296|NCT00560794|Secondary|Time to MRD Progression|"Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation.~MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days|Full analysis set|||days||95% Confidence Interval|Median
2794297|NCT00560794|Secondary|Time to Hematological Relapse|"The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy.~Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods."|Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days.|Full analysis set|||days||95% Confidence Interval|Median
2794298|NCT00560794|Secondary|Percentage of Participants With an MRD Response After Each Treatment Cycle|"MRD Response is defined as:~If Philadelphia Chromosome (Ph)+ or t(4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.~If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|At the end of each treatment cycle - Weeks 4, 10, 16, and 22.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2794299|NCT00560794|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment|"MRD Response is defined as:~If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.~If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|Within 4 treatment cycles, 24 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2794300|NCT00560755|Secondary|Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1|Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794301|NCT00560755|Secondary|Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1|The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants|||Number
2794302|NCT00560755|Secondary|Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1|Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.|Up to Day 28 (28 days after ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794303|NCT00560755|Secondary|Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.|From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794304|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2|Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.|Up to Day 84 (up to 42 days after ProQuad® Dose 2)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794305|NCT00560755|Primary|Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2|Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.|Up to Day 84 (up to 42 days after ProQuad® Dose 2)|All participants who received the first ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794306|NCT00560755|Primary|Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2|The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794307|NCT00560755|Primary|Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2|Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794308|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2|Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794309|NCT00560755|Primary|Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2|Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794310|NCT00560755|Primary|Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2|Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794311|NCT00560755|Primary|Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2|The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794312|NCT00560755|Primary|Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2|The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.|Up to Day 46 (for 4 days following ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794313|NCT00560755|Primary|Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2|The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794314|NCT00560755|Primary|Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2|The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.|Up to Day 70 (up to 28 days after ProQuad® Dose 2)|All participants who received the second ProQuad® dose and had safety follow-up data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2794315|NCT00560703|Primary|Change in Ocular Surface Disease Index (OSDI)|"OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):~OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)~Range of OSDI is 0 to 100 (higher score indicates worse condition)."|Baseline to Week 12||||Scores on a scale||Standard Deviation|Mean
2794316|NCT00560703|Primary|Change in Bulbar Conjunctival Hyperemia|"Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:~None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness"|Baseline to Week 12||||Scores on a scale||Standard Deviation|Mean
2794317|NCT00560612|Secondary|Change in Hospital Anxiety and Depression Scale Scores|The total HADS score is presented, which is regarded as a global measure of psychological distress. The total score ranges from 0-42. Each individual question is rated on a 4 point scale (0=absent to 3 =extreme presence). The higher the score, the greater level of psychological distress. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Change in Scores (12 Weeks-Baseline)||||units on a scale||Standard Deviation|Mean
2794318|NCT00560612|Secondary|Change in Connor Davidson Resilience Scale Scores|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Change in Scores (12 Weeks-Baseline)||||units on a scale||Standard Deviation|Mean
2794319|NCT00560612|Secondary|Change in Short PTSD Rating Interview Scores|The SPRINT contains 8 questions which are rated on a 0-4 scale (0=not at all; 4=very much). The total score is computed from summing questions #1-8 (range=0-32). The higher the total score, the worse the symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Change in Scores (12 weeks-Baseline)||||units on a scale||Standard Deviation|Mean
2794320|NCT00560612|Primary|Change in Clinician Administered PTSD Scale (CAPS) Scores|"Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores."|Change in Scores (12 weeks-Baseline)||||Units on a scale||Standard Deviation|Mean
2794321|NCT00560573|Other Pre-specified|Recommended Phase 2 Dose (RP2D)|The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration|Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.|||mg/kg|||Number
2794322|NCT00560573|Other Pre-specified|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1|Cycle 1, up to Day 21|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.|||mg/kg|||Number
2794323|NCT00560573|Secondary|Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels|To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment|Baseline, Day 8, end of study|Biomarker analysis set: All enrolled participants who received at least 1 dose of study medication.|||ng/mL||Inter-Quartile Range|Mean
2794324|NCT00560573|Secondary|Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)|ADA analysis set: All enrolled participants who received at least 1 dose of study medication.|||Percentage of participants|||Number
2794325|NCT00560573|Secondary|Duration of Response (DR)|For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|No analysis of this parameter was performed. Due to the exploratory nature of the study, the analysis of the efficacy of figitumumab was limited to the assessment of clinical benefit response and PFS.||||||
2794326|NCT00560573|Secondary|Progression-Free Survival (PFS)|Time from the date of enrollment to date of documented disease progression, or death due to any cause|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.|||months||95% Confidence Interval|Median
2794327|NCT00560573|Secondary|Percentage of Participants With Objective Response or Prolonged Stabilization|Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response|Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.|||Percentage of participants||95% Confidence Interval|Number
2794328|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng*hr/L||Standard Deviation|Mean
2794329|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed|Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng/mL||Standard Deviation|Mean
2794330|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng*hr/L||Standard Deviation|Mean
2794331|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine|Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng/L||Standard Deviation|Mean
2794332|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||ng*hr/L||Standard Deviation|Mean
2794333|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin|Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||nanogram (ng)/mL||Standard Deviation|Mean
2794334|NCT00560573|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab|Concentration at the end of Cycle 4|0 (pre-dose) in Cycle 5 Day 1|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||mg/L||Standard Deviation|Mean
2794335|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods|0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||mg*hr/L||Standard Deviation|Mean
2794336|NCT00560573|Secondary|Concentration at the End of Infusion (Cinf) for Figitumumab|Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods|Cycle 1 for dose escalation and Cycle 4 for dose expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.|||mg/liter (L)||Standard Deviation|Mean
2794337|NCT00560573|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment|Start of treatment up to end of Cycle 1, Day 21|Safety analysis set: All enrolled participants in the dose escalation who received at least 1 dose of study medication.|||participants|||Number
2794338|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs)|The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."|||Number of CTC/ml of blood||Standard Deviation|Median
2794339|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)|The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."|||number of CTC expressing IGF-1R/ml blood||Standard Deviation|Median
2794340|NCT00560560|Secondary|Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.|Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)|Participants for whom at least one ADA measurement was done. The outcome was not analyzed and only listing of ADA level for each participant was available.||||||
2794341|NCT00560560|Secondary|Descriptive Summary of Figitumumab Concentration Versus Time|The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5|Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5|All participants for whom PK was assessed at least once. The numbers of participants analyzed are numbers of observation (non-missing concentrations). The numbers for 20 mg/kg group are 84,7,3,2,13 for five cycles, respectively. The numbers for 30 mg/kg group are 79,8,2,2,8 for five cycles, respectively.|||miligrams/liter (mg/L)||Standard Deviation|Mean
2794342|NCT00560560|Secondary|Percentage of Participants With Objective Response|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.|Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months|Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2794358|NCT00560508|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||percentage of participants|||Number
2794343|NCT00560560|Secondary|Progression-Free Survival (PFS)|The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.|Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.|All enrolled participants.|||months||95% Confidence Interval|Median
2794344|NCT00560560|Secondary|Overall Survival|The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|From date of enrollment until death or censorship, up to 33 months|All enrolled participants.|||Months||95% Confidence Interval|Median
2794345|NCT00560560|Primary|Estimate of the 6 Month Survival Probability|The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|Baseline up to Month 6|All enrolled participants.|||Percent chance of survival||95% Confidence Interval|Number
2794346|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
2794347|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794348|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
2794349|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
2794350|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||mg per day||Standard Deviation|Mean
2794351|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
2794352|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
2794353|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
2794354|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of on-time||Standard Deviation|Mean
2794355|NCT00560508|Secondary|Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||Percentage of off-time||Standard Deviation|Mean
2794356|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||percentage of participants|||Number
2794357|NCT00560508|Secondary|Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Deviation|Mean
2794714|NCT00558259|Secondary|Centrally Confirmed Unexplained Deaths During the Intended Treatment Period|Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.|6 months|FAS and analysed as randomised.|||participants|||Number
2794359|NCT00560508|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||percentage of participants|||Number
2794360|NCT00560508|Secondary|Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)|Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)|Week 12 to Week 16|Full Analysis Set (FAS 2) for the open-label period|||percentage of participants|||Number
2794361|NCT00560508|Secondary|Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794362|NCT00560508|Secondary|Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment|Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration|from Visit 1 to Visit 8 after pramipexole ER|Full Analysis Set (FAS).|||ng/mL|Participants|Standard Error|Mean
2794363|NCT00560508|Secondary|Trough Plasma Concentration at Steady State|Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.|at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment|Full Analysis Set (FAS)|||ng/ml||Standard Deviation|Geometric Mean
2794364|NCT00560508|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|12 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.|||percentage of participants|||Number
2794365|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||mg per day||Standard Error|Least Squares Mean
2794366|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||percentage of participants|||Number
2794367|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794368|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794369|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794370|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794371|NCT00560508|Secondary|Responder Rate For Patient Global Impression of Improvement (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||percentage of participants|||Number
2794372|NCT00560508|Secondary|Responder Rate For Clinical Global Impression of Improvement (CGI-I)|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||percentage of participants|||Number
2794373|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
2794374|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
2794375|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
2795648|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients|||Participants|||Number
2794376|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of on-time||Standard Error|Least Squares Mean
2794377|NCT00560508|Secondary|Change From Baseline in Percentage Off-time|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||Percentage of off-time||Standard Error|Least Squares Mean
2794378|NCT00560508|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)|||UPDRS scores on a scale||Standard Error|Least Squares Mean
2794379|NCT00560417|Secondary|Total Daily Insulin Dose at Endpoint (LOCF)||Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||Units of Insulin||Standard Deviation|Mean
2794380|NCT00560417|Secondary|Change From Baseline in Body Weight at Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||kilograms||Standard Deviation|Mean
2794381|NCT00560417|Secondary|Actual Body Weight at Baseline and Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||kilograms||Standard Deviation|Mean
2794382|NCT00560417|Secondary|Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)|Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||episodes/participant/365 days||Standard Deviation|Mean
2794383|NCT00560417|Secondary|Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)|Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percentage of participants|||Number
2794384|NCT00560417|Secondary|Glycemic Variability at Baseline and Endpoint (LOCF)|Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||mg/dL||Standard Deviation|Mean
2794385|NCT00560417|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)|SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2794386|NCT00560417|Secondary|Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%||Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of participants|||Number
2794387|NCT00560417|Secondary|Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
2794388|NCT00560417|Secondary|Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|24 weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
2794389|NCT00560417|Primary|Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.|||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
2794390|NCT00560404|Secondary|Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40|Vital signs included blood pressure, pulse rate and body weight.|From Baseline to Week 40|The analysis was performed on safety population.|||participants|||Number
2794391|NCT00560404|Secondary|Number of Participants With Abnormal Changes in ECG From Baseline to Week 40|Twelve-lead ECG was performed.|From Baseline to Week 40|The analysis was performed on Safety population.|||participants|||Number
2794392|NCT00560404|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 40|The analysis was performed on Safety Population.|||participants|||Number
2794393|NCT00560404|Secondary|Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36|The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point..|||International units/Liter||Standard Deviation|Mean
2794394|NCT00560404|Secondary|Mean Values of Transferrin Saturation at Baseline and Week 36|The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||percentage||Standard Deviation|Mean
2794395|NCT00560404|Secondary|Mean Values of Ferritin Concentration at Baseline and Week 36|Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||micrograms per liter||Standard Deviation|Mean
2794396|NCT00560404|Secondary|Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36|The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||gram/litre||Standard Deviation|Mean
2794397|NCT00560404|Secondary|Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36|Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||micromoles per liter||Standard Deviation|Mean
2794398|NCT00560404|Secondary|Mean Values of Leukocytes and Platelets Count at Baseline and Week 36|The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||10^9/Litre||Standard Deviation|Mean
2794399|NCT00560404|Secondary|Mean Values of Mean Corpuscular Volume at Baseline and Week 36|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||femtoliters||Standard Deviation|Mean
2794400|NCT00560404|Secondary|Mean Values of Hematocrit at Baseline and Week 36|Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||fraction||Standard Deviation|Mean
2794401|NCT00560404|Secondary|Mean Values of Hemoglobin Concentration at Baseline and Week 36|The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.|||g/dL||Standard Deviation|Mean
2794402|NCT00560404|Secondary|Number of Participants Received Red Blood Cells Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.|Up to Week 28|The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not|||participants|||Number
2794403|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.|||participants|||Number
2794404|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|DTP (Weeks 0 to 28)|The analysis was performed on ITT population.|||participants|||Number
2794405|NCT00560404|Secondary|Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period|Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.|EEP (Week 29 to Week 36)|The analysis was performed on ITT population.|||days||Standard Deviation|Mean
2794406|NCT00560404|Secondary|Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period|Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.|||percentage of participants|||Number
2794407|NCT00560404|Secondary|Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period|The Baseline (Safety Verification Period) was from Week - 4 to Week -1.|Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)|The analysis was performed on ITT population.|||g/dL||Standard Deviation|Mean
2794408|NCT00560404|Primary|Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period|The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.|EEP (Week 29 to Week 36)|Per-protocol population included participants who received at least one dose of C.E.R.A. and had data of at least one follow-up variable excluding those participants who had not adhere the inclusion/exclusion criteria, had less than 3 recorded Hb values, and received any other epoetin alpha and blood transfusion in Weeks 0 to 44.|||percentage of participants|||Number
2794409|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN - 8.0 mg/dL, GR2: <8.0 - 7.0 mg/dL, GR3: <7.0 - 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN - 11.5 mg/dL, GR2: >11.5 - 12.5 mg/dL, GR3: >12.5 - 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: <LLN - 1.2 mg/dL, GR2: <1.2 - 0.9 mg/dL, GR3: <0.9 - 0.7 mg/dL, GR4: <0.7 mg/dL. Phosphorus (low): GR1: <LLN - 2.5 mg/dL, GR2: <2.5 - 2.0 mg/dL, GR3: <2.0 - 1.0 mg/dL, GR4: <1.0 mg/dL. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794410|NCT00560391|Secondary|Number of Participants With Minimal Response|Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794411|NCT00560391|Secondary|Number of Participants With Partial Response|Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794412|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794413|NCT00560391|Primary|Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia|As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=<LLN(lower limit of normal)-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3:<2.0-1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9/L; GR2=<1.5-1.0*10^9/L; GR3:<1.0-0.5*10^9/L; GR4:<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3:<8.0-6.5g/dL; GR4:<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3:<50.0-25.0*10^9/L; GR4:<25.0*10^9/L. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794414|NCT00560391|Primary|Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.|Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794415|NCT00560391|Secondary|Number of Participants With Complete Response and Very Good Partial Response|Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour.|Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||participants|||Number
2794416|NCT00560391|Primary|Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone|The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)|||participants|||Number
2794417|NCT00560391|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination.|From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)|||participants|||Number
2794418|NCT00560391|Primary|Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)|The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.|||mg|||Number
2794419|NCT00560352|Primary|MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||mg/m^2|||Number
2794420|NCT00560352|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.|Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.|||Participants|||Number
2794421|NCT00560352|Secondary|Progression-free Survival|Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.|Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||Months||95% Confidence Interval|Median
2794422|NCT00560352|Secondary|Duration of Response|Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first.|First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)|All response-evaluable participants who achieved a response.|||Months|||Number
2794436|NCT00560235|Secondary|Overall Survival (OS)|Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment|All enrolled participants with ESFT and who started treatment with figitumumab.|||months||95% Confidence Interval|Median
2794437|NCT00560235|Secondary|Progression-Free Survival (PFS)|PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).|Baseline and every cycle (4 weeks), until progression or death|All enrolled participants with ESFT and who started treatment with figitumumab.|||months||95% Confidence Interval|Median
2794423|NCT00560352|Secondary|Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry|S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.|Day 1 until last tumor assessment (maximum reached: 9 months)|All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||Percentage of participants|||Number
2794424|NCT00560352|Primary|Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone|||mg QD|||Number
2794425|NCT00560313|Primary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.|The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.|One month after vaccinations|The analysis was done on the per protocol population.|||participants|||Number
2794426|NCT00560313|Primary|Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:~prior to the first vaccination~30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.|||percentage||95% Confidence Interval|Number
2794427|NCT00560313|Primary|Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.|Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.|One month after vaccinations|The analysis was done on the per protocol population.|||titer||95% Confidence Interval|Geometric Mean
2794428|NCT00560313|Primary|Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:~prior to the first vaccination~30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.|||percentage||95% Confidence Interval|Number
2794429|NCT00560313|Primary|Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.|Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.|One month after vaccinations|The analysis was done on the per protocol population.|||titer||95% Confidence Interval|Geometric Mean
2794430|NCT00560235|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.|Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)|All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of <6.64.|||participants|||Number
2794431|NCT00560235|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.|||mg*hr/L||Geometric Coefficient of Variation|Geometric Mean
2794432|NCT00560235|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 1 cycle (4 weeks) in this study.|Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.|||milligram*hour per liter (mg*hr/L)||Geometric Coefficient of Variation|Geometric Mean
2794433|NCT00560235|Secondary|Plasma Concentration at End of Infusion (Cendinf)||Cycle 1 Day 2 and Cycle 5 Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2794434|NCT00560235|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin is the concentration at the end of treatment cycle (next cycle predose).|Cycle 6: predose on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2794435|NCT00560235|Secondary|Maximum Observed Plasma Concentration (Cmax)||Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.|||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2794438|NCT00560235|Primary|Objective Response Rate (ORR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.|Baseline and every cycle (4 weeks), for up to 6 cycles|All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off.|||percentage of participants||95% Confidence Interval|Number
2794439|NCT00560105|Secondary|Change in CCQ Score|The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.|8 weeks|A patient population included|||units on a scale||Standard Deviation|Mean
2794440|NCT00560105|Secondary|Quality of Life Questionnaire/Daily Diary|St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)|8 weeks|All patient data included|||units on a scale||Standard Deviation|Mean
2794441|NCT00560105|Secondary|FEV1 - Baseline and Device Comparisons|Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.|8 weeks|A data collected included|||liter||Standard Deviation|Mean
2794442|NCT00560105|Primary|Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight|In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.|8 weeks|All patient data included|||g||Standard Deviation|Mean
2794443|NCT00560066|Primary|Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV|Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.|From Day 1 up to and including Day 7 post-vaccination|Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.|||Subjects|||Number
2794444|NCT00560066|Secondary|Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.|||Ratio||95% Confidence Interval|Geometric Mean
2794445|NCT00560066|Secondary|Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.|||Titers||95% Confidence Interval|Geometric Mean
2794446|NCT00560066|Secondary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV|Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.|||Percentages of Subjects||95% Confidence Interval|Number
2794447|NCT00560066|Secondary|Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV|Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set [FAS]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)|||Percentages of Subjects||95% Confidence Interval|Number
2794448|NCT00560066|Secondary|Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.|From Day 1 through Day 7 post-vaccination|Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.|||Subjects|||Number
2794449|NCT00560066|Secondary|Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).|From Day 1 through Day 7 post-vaccination|Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.|||Subjects|||Number
2794451|NCT00559988|Secondary|Change in Quality of Life Score|Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability.|1 year|Subjects with paired baseline and 1 year Quality of Life scores|||Scores on a scale||Standard Deviation|Mean
2794452|NCT00559988|Secondary|Rate of Cardioembolic and Non-cardioembolic Stroke||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
2794453|NCT00559988|Secondary|Mean Atrial Fibrillation/Atrial Flutter Burden||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||percent daily burden||Standard Deviation|Mean
2794454|NCT00559988|Secondary|Rate of Major Bleeding Events||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
2794455|NCT00559988|Secondary|Rate of Fatal or Disabling and Non-disabling Stroke||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
2794456|NCT00559988|Secondary|Rate of Ischemic and Hemorrhagic Stroke||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
2794457|NCT00559988|Secondary|Rates of All-cause Mortality||Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years||||Participants|||Count of Participants
2794458|NCT00559988|Primary|Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed|The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.|From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years|Intent to treat analysis of all enrolled subjects|||percentage of participants-Kaplan Meier|||Number
2794459|NCT00559962|Secondary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT|||Percent of Hepatic Fat||Standard Deviation|Mean
2794460|NCT00559962|Primary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT|||Percent of Hepatic Fat||Standard Deviation|Mean
2794461|NCT00559949|Secondary|Overall Survival (OS)|Overall Survival using the Kaplan-Meier method with associated confidence intervals. OS analysis was intended to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants|||months||95% Confidence Interval|Median
2794462|NCT00559949|Secondary|Occurrence of Treatment Related Adverse Events|Number of participants with related adverse events, per category and Grade category. Toxicity assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|All participants|||adverse events|||Number
2794463|NCT00559949|Secondary|Median Progression-Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Secondary end points include toxicity, progression free survival, and overall survival. Due to the small sample size and absence of high quality historic data for this disease, these analyses were planned to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants|||weeks||95% Confidence Interval|Median
2794464|NCT00559949|Primary|Objective Response Rate (ORR)|ORR: Complete Response (CR) and Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A conservative estimate of the response rate of the best-studied agent in this disease, doxorubicin, is approximately 5%. Therefore, investigators will assume that selumetinib (AZD6244, NSC 741078) would be worth further pursuit if the response rate (CR+PR) were at least 20%.|Up to 2 years|All evaluable participants|||Participants|||Count of Participants
2794465|NCT00559936|Primary|Ocular and Systemic Safety|The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.|All study visits|Participants treated with investigational medication were analyzed.|||participants|||Number
2794466|NCT00559936|Primary|The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.|The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.|Six Months|Participants who received investigational treatment were analyzed.|||percent change since baseline||Standard Deviation|Mean
2794467|NCT00559897|Primary|PET Response Rate||FLT PET scan will be done 6-8 days after the dose of zoledronic acid|||||||
2794618|NCT00558571|Primary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 6 weeks|treated set|||participants|||Number
2794468|NCT00559845|Secondary|Percentage of Participants Experiencing Any Adverse Event|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 7.5 years|Safety population, defined as all participants who received at least one infusion of Bevacizumab.|||percentage of participants|||Number
2794469|NCT00559845|Secondary|Overall Survival|Overall survival was defined as the time from enrollment of participant to death from any cause.|Up to 7.5 years|Data for the outcome measure was not collected.||||||
2794470|NCT00559845|Secondary|Percentage of Participants With Disease-Free Interval|Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented.|Months 12, 24, 36, 48, and 60|ITT population, defined as all participants that were included in the trial and underwent surgery. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
2794471|NCT00559845|Secondary|Percentage of Participants With Breast-Conserving Surgery|Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment.|Up to 7.5 years|ITT population, defined as all participants that were included in the trial and underwent surgery.|||percentage of participants|||Number
2794472|NCT00559845|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions.|Up to 7.5 years|ITT population, defined as all participants that were included in the trial and underwent surgery.|||percentage of participants|||Number
2794473|NCT00559845|Primary|Percentage of Participants With Pathological Complete Response Following Principle Investigator Review|Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.|Up to 7.5 years|Intention-to-Treat (ITT) population, defined as all participants that were included in the trial and underwent surgery.|||percentage of participants|||Number
2794474|NCT00559754|Secondary|Percentage of Participants With pCR by RKISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. RKISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794475|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794476|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. AGTR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794477|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pMAPK gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794478|NCT00559754|Secondary|Percentage of Participants With pCR by ENOS Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794479|NCT00559754|Secondary|Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. IGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794480|NCT00559754|Secondary|Percentage of Participants With pCR by HIF Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794481|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pAKT gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794482|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794483|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794484|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotension Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Angiotensin protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794485|NCT00559754|Secondary|Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794486|NCT00559754|Secondary|Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794487|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794488|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794489|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794490|NCT00559754|Secondary|Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.|||percentage of participants|||Number
2794491|NCT00559754|Secondary|Percentage of Participants With pCR by Proliferation of Ki67|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).|After Week 24 (surgery)|Population evaluable for anatomopathological response with evaluable levels of the specified biomarker; data were missing for 2 participants.|||percentage of participants|||Number
2794492|NCT00559754|Secondary|Percentage of Participants With Breast-Conserving Surgery|Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).|Week 24|ITT population; only those participants who underwent surgery were included in the analysis|||percentage of participants|||Number
2794493|NCT00559754|Secondary|Percentage of Participants With Objective Clinical Response|Overall clinical response is the best response obtained through physical examination and/or radiological tests after completion of chemotherapy cycles. The percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) and was categorized as clinical response (CR+PR) or clinical benefit (CR+PR+ no change [NC]). Per RECIST, CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Within 28 days of enrollment, Weeks 12 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
2794494|NCT00559754|Primary|Percentage of Participants With Pathological Complete Response (pCR)|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.|After Week 24 (surgery)|Population evaluable for anatomopathological response: participants who satisfied all inclusion criteria and none of the exclusion criteria, received at least 2 cycles of chemotherapy treatment, and were evaluated pathologically.|||percentage of participants||95% Confidence Interval|Number
2794495|NCT00559637|Secondary|Total Number of Red Blood Cell (RBC) Transfusions|RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|Baseline to Month 9|ITT population|||number of transfusions|||Number
2794496|NCT00559637|Secondary|Total Number of Dose Adjustments|A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment.|Baseline until Month 8|ITT population|||dose adjustments|||Number
2794497|NCT00559637|Secondary|Time to Increase of Hemoglobin Value to Over 11 g/dL|The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL.|Baseline to Month 9|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Standard Deviation|Mean
2794498|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-13 g/dL|The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population|||months||Standard Deviation|Mean
2794499|NCT00559637|Primary|Change From Baseline in Hemoglobin Value to the Evaluation Phase|The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.|Baseline, evaluation phase (Months 8 and 9)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||g/dL||Standard Deviation|Mean
2794500|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-12 g/dL|The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population|||months||Standard Deviation|Mean
2794615|NCT00558571|Secondary|t1/2 of Empagliflozin|terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set|||hours||Geometric Coefficient of Variation|Geometric Mean
2794501|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|ITT population|||percentage of participants||95% Confidence Interval|Number
2794502|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|Intent to treat (ITT) population included all participants who received at least one dose of study medication with at least one hemoglobin value measured during treatment period.|||percentage of participants||95% Confidence Interval|Number
2794503|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
2794504|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
2794505|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
2794506|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.|||participants|||Number
2794507|NCT00559585|Primary|Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population|Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants in the Anti-TNF Failure Sub-study who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||participants|||Number
2794508|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821|The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.|Days 169, 729, 1261, 1821|All participants who entered the LT period, received at least 1 dose of study drug during the LT period, and had HAD-QI scores at baseline and at specified days were summarized.|||participants|||Number
2794509|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
2794619|NCT00558571|Primary|Number of Subjects With Drug Related Adverse Events|number of subjects with investigator-defined drug-related adverse events.|from drug administration up to 6 weeks|treated set: comprised all 78 patients who received at least one dose of study medication|||participants|||Number
2794510|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
2794511|NCT00559585|Secondary|Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||units on a scale||95% Confidence Interval|Mean
2794512|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
2794513|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.|||participants|||Number
2794514|NCT00559585|Secondary|Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||participants|||Number
2794515|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result reported during the short-term period.|||participants|||Number
2794516|NCT00559585|Secondary|Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period|C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.|Baseline to Days 15, 29, 57, 85, 113, 141, and 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||percent change||Inter-Quartile Range|Median
2794517|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4).|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.|||participants|||Number
2794518|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.|Dosing Interval between Days 113 and 141 (TAU=28 days)|Participants in the sub-study who received at least 1 dose of study medication and who had adequate PK profiles for analysis|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2794519|NCT00559585|Secondary|Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept||Dosing interval between Days 113 and 141 (TAU=28 days)|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis|||µg*h/mL||Standard Deviation|Geometric Mean
2795563|NCT00552669|Secondary|Target Vessel Revascularization (TVR)|Efficacy end point was TVR as revasacularization of the treated vessel.|18 months|We analyzed the number of vessels treated per group by ITT and the imputation technique was LOCF.|||vessels|||Number
2794520|NCT00559585|Secondary|Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).|End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants in the Sub-study who received at least 1 dose of study medication and who had adequate PK profiles were analyzed|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2794521|NCT00559585|Secondary|Double-blind Period: Maximum Observed Serum Concentration of Abatacept||End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis|||µg/mL||Standard Deviation|Geometric Mean
2794522|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.|Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)|Participants who received at least 1 dose of study medication and who had adequate PK profiles were analyzed. n= number of participants available at each specific time point.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2794523|NCT00559585|Secondary|Double-blind Period: Minimum Observed Serum Concentration of Abatacept||Days 57, 85, 113, 120, 127, 134, 141, and 169|Participants who received at least 1 dose of study medication and from whom at least 1 pharmacokinetic (PK) sample was collected and reported (N). Only participants with adequate PK profiles were included in the summary statistics and statistical analysis (n).|||µg/mL||Standard Deviation|Geometric Mean
2794524|NCT00559585|Secondary|Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. N=number of participants with assessments available.|||participants|||Number
2794525|NCT00559585|Secondary|Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.|||participants|||Number
2794526|NCT00559585|Secondary|Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.|||participants|||Number
2794527|NCT00559585|Secondary|Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2794528|NCT00559585|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions|Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2794529|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2794616|NCT00558571|Secondary|Tmax of Empagliflozin|time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set|||hours||Full Range|Median
2794530|NCT00559585|Secondary|Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2794531|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available|||participants|||Number
2794532|NCT00559585|Secondary|Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.|Baseline to Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.|||units on a scale||Standard Error|Mean
2794533|NCT00559585|Secondary|Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.|||units on a scale||Standard Deviation|Mean
2794534|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Day 169|PP population, defined as participants who are compliant with the study criteria.|||participants|||Number
2794535|NCT00559585|Primary|Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Day 169|Per protocol (PP) population, defined as participants who are compliant with the study criteria.|||participants|||Number
2794536|NCT00559507|Secondary|Median Time to Treatment Failure||From the start of treatment up to 4 weeks after completion of study treatment||||Days||Full Range|Median
2794537|NCT00559507|Secondary|Overall Response Rate (CR and PR)|Overall Response rate is defined as the sum of the complete response rate and partial response rate. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|From start of treatment to 24 weeks after completion of study treatment||||participants|||Number
2794538|NCT00559507|Primary|Disease Control Rate (DCR)|DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|After 24 weeks of study therapy||||participants|||Number
2794620|NCT00558558|Primary|Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)|Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.|Baseline and Week 4 +/- 5 days|The participants were not eligible for analysis based on the primary outcome timeline.||||||
2794539|NCT00559468|Secondary|Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.8 indicates a faster recovery from NMB.|Up to 3 minutes after sugammadex administration|All randomized participants who received sugammadex and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2794540|NCT00559468|Secondary|Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB.|Up to 3 minutes after sugammadex administration|All randomized participants who received sugammadex and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2794541|NCT00559468|Primary|Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.|Up to 3 minutes after sugammadex administration|All randomized participants who received sugammadex and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
2794542|NCT00559377|Secondary|Response to XRT Using RECIST|Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols|time to disease progression or 2 years following first FMISO scan|PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim.||||||
2794543|NCT00559377|Secondary|Relationship Between Ki67 and Regional FMISO Uptake in Tumor|The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Ki67 values were compared to FMISO uptake.|||percentage of staining||Standard Deviation|Mean
2794544|NCT00559377|Secondary|Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor|The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.|||units on a scale 0=low, 8=high||Full Range|Median
2794545|NCT00559377|Primary|Disease-free Survival (DFS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.|Up to 2 years|Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free.|||participants disease-free after 2 years|||Number
2794546|NCT00559377|Primary|Overall Survival (OS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.|For up to 2 years|1 patient has been lost to follow up for survival measures.|||participants still alive after 2 years|||Number
2794547|NCT00559364|Secondary|Percentage of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and watery. Percentage of stools of a specific consistency for each patient was calculated as: (total number of stools of specific consistency during the completed days of the inpatient period/ total number of stools during the completed days of the inpatient period)*100. Mean percentage of stool categorized as per consistency for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.|||percentage of stools||Standard Deviation|Mean
2794548|NCT00559364|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each patient was calculated from frequency of stools by the patient per day. Mean daily number of stools during the collection period (Day 1 to Day 4 or Day 5 in inpatient period of treatment phase) for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.|||stools per day||Standard Deviation|Mean
2794549|NCT00559364|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|Intent-to-treat (ITT) population included all randomized patients. Missing values at treatment phase were imputed using the median (50th percentile) of all non-missing values within a treatment group.|||percent CFA||Standard Deviation|Mean
2794550|NCT00559273|Secondary|Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response|The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population. Here, N=number of participants analyzed for this measure.|||percentage of participants|||Number
2794551|NCT00559273|Secondary|Percentage of Participants With Stable Hemoglobin Response|A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population.|||percentage of participants||95% Confidence Interval|Number
2794552|NCT00559273|Secondary|Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL|Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.|Baseline to Week 8|ITT population. Here, N=number of participants evaluable for this measure.|||percentage of participants|||Number
2794553|NCT00559273|Secondary|Percentage of Participants With Red Blood Cell (RBC) Transfusions|The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.|Baseline up to Week 28|ITT population.|||percentage of participants|||Number
2794554|NCT00559273|Secondary|Time to Hemoglobin Response|Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.|Baseline up to Week 28|ITT population.|||days||95% Confidence Interval|Median
2794555|NCT00559273|Secondary|Hemoglobin (Hb) Concentration Over the Time|The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)|ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.|||g/dL||Standard Deviation|Mean
2794556|NCT00559273|Primary|Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)|ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.|||g/dL||Standard Deviation|Mean
2794557|NCT00559273|Primary|Percentage of Participants With Hemoglobin (Hb) Response|Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.|Baseline up to Week 28|Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.|||percentage of participants||95% Confidence Interval|Number
2794558|NCT00559104|Secondary|Short-term and Long-term Treatment-related Toxicities|Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.|Any time after transplant|per protocol|||participants|||Number
2794559|NCT00559104|Primary|Mortality|Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.|Assessed at date of death post-transplant|per protocol|||participants|||Number
2794560|NCT00559104|Primary|Progression|"Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.~Below is reported Progression-free Survival: event is relapse or progression, or death."|Assessed at date of progression post-transplant|per protocol|||participants|||Number
2794561|NCT00559013|Primary|Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.||Discharge and 1 Month post surgery||||Participants|||Number
2794562|NCT00558896|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.|Duration of study (up to 5 years)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.|||months||95% Confidence Interval|Median
2794563|NCT00558896|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method.~Progression was defined as any one or more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25% increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
2794564|NCT00558896|Primary|The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)|"Response that was confirmed on 2 consecutive evaluations~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of study (up to 3 years)||||participants|||Number
2794621|NCT00558519|Other Pre-specified|Outcomes of Adolescent and Young Adult Patients Treated on This Study Compared With Those of Patients Treated Per COG-AALL0232||Up to 10 years post-registration|||||||
2794565|NCT00558870|Primary|Dose Escalation Index at Day 15 (+/- 3 Days)|Intended index period from baseline to Day 15 to determine whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15 (+/- 3 days). To determine whether the methadone group of individuals has a lower dose escalation index as compared to the morphine alone group: Participant dosages measured at baseline and daily until end of study (day 15), total daily dose of methadone converted to daily morphine equivalent daily dose for cancer pain and added to total daily morphine dosages. From these daily values, maximum dose recorded will be Opioid Maximum Dose (OMD). Opioid escalation index measured as described in Outcome 1 above (milligrams calculated by formula, (OMD-OSD)/days). Low index indicates achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time.|Day 15 (+/- 3 days)|No analysis possible due to small participation numbers.||||||
2794566|NCT00558870|Primary|Number of Participants With Objective Response (OR)|Objective response (OR) is defined as a dose escalation index <20 where Opioid escalation index measured in milligrams is calculated by the formula, (OMD-OSD)/days, OMD = Opioid maximum dose as expressed in equianalgesic dose of oral morphine in milligrams, OSD= Opioid starting dose at the time of referral to palliative care/ pain specialist for the treatment of cancer pain as expressed in equianalgesic dose of oral morphine in milligrams. A low index indicates the achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time. OR used in determining whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15.|Day 15 (+/- 3 days)|There were no participants analyzed in each group for outcome variable; the study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups.||||||
2794567|NCT00558844|Secondary|CFQ-R Respiratory Scale (Relative Change % From Baseline)|Quality of Life was measured by the absolute change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory scale. Disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms in patients with a diagnosis of cystic fibrosis. Scores range from 0 to 100, with higher scores indicating better health. Scores for each Health Related Quality of Life (HRQoL) domain; after recoding, each item is summed to generate a domain score and standardized.|Day 15, Day 28 and Day 42|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||Percent (%)||Standard Deviation|Mean
2794568|NCT00558844|Secondary|Duration of Systemic Anti-Pseudomonal Rescue Therapy||Through study duration, approximately 84 days|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||days||Standard Deviation|Mean
2794569|NCT00558844|Secondary|Density of Pseudomonas Aeruginosa in Sputum|Change (log10 CFU) from Baseline by Study Day and Treatment Arm|Day 7, Day 14, Day 21, Day 28 and Day 35|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||Log 10 CFU/g||Standard Deviation|Mean
2794570|NCT00558844|Secondary|Pulmonary Function: Pre-Dose FEV1 (%-Predicted)|Relative Change (%) from Baseline to Day 28, Day 56, Day 70, and Day 84 in Pulmonary Function|Baseline, Day 28, Day 56, Day 70 and Day 84|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||Percent (%)||Standard Deviation|Mean
2794571|NCT00558844|Secondary|Pharmacokinetics (PK) of Arikayce™ in Serum|Measure PK parameter (AUC) of Arikayce in Serum|Day 1, Day 14 and Day 28|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||mg*hr/L||Standard Deviation|Mean
2794572|NCT00558844|Secondary|Pharmacokinetics (PK) of Arikayce™ in Urine|Measure PK parameter (Ae0-24) of Arikayce in urine|Day 1, Day 14 and Day 28|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||mg||Standard Deviation|Mean
2794573|NCT00558844|Secondary|Pharmacokinetics (PK) of Arikayce™ in Sputum|Measure PK parameters (sputum concentration) of Arikayce in sputum, pre- and post-dose|Day 1 post-dose, Day 14 pre- and post-dose, Day 28 pre- and post-dose|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||mcg/g||Standard Deviation|Mean
2794574|NCT00558844|Secondary|Pharmacokinetics of Arikayce™ in Serum|Measure PK parameter (Cmax) of Arikayce in serum|Day 1, Day 14 and Day 28|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||mg/L||Standard Deviation|Mean
2794575|NCT00558844|Primary|Number of Participants With Treatment-Emergent Adverse Events|To evaluate the safety and tolerability of 28 days of daily dosing of nebulized Arikayce™, liposomal amikacin for inhalation.|56 days|Analyses were performed using the modified intent-to-treat (mITT) population, defined as all randomized subjects who received at least one dose of study drug|||Participants|||Count of Participants
2794576|NCT00558831|Primary|Subject Reported Change From Baseline Scale|"-1=worse 0=unchanged~1=mild improvement~2=moderate improvement~3=clear"|baseline and 1 month||||Participants|||Number
2794577|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Specificity (%)|Participants||Number
2794622|NCT00558519|Other Pre-specified|"Adherence of Adult Hematologists/Oncologists and Their Patients to a Pediatric Acute Lymphoblastic Leukemia Treatment Regimen and Identification of Reasons for Variances"||Up to 10 years post-registration|||||||
2794578|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Sensitivity (%)|Participants||Number
2794579|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Specificity (%)|Participants||Number
2794580|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Sensitivity (%)|Participants||Number
2794581|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Specificity (%)|Participants||Number
2794582|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)|||Sensitivity (%)|Participants||Number
2794583|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 3|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose||||Hounsfield Units||Standard Deviation|Mean
2794584|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 2|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose||||Hounsfield Units||Standard Deviation|Mean
2794585|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 1|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose||||Hounsfield Units||Standard Deviation|Mean
2794586|NCT00558792|Secondary|Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater|Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.|up to 72 hours post dose||||Participants who Experienced AE(s)|||Number
2794587|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose||||Segments Visualized Accurately|Participants||Number
2794928|NCT00556933|Primary|Average of Renal Function|Calculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24.|Two years||||ml/min/1.73m2||Standard Deviation|Mean
2794588|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose||||Segments Visualized Accurately|Participants||Number
2794589|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose||||Segments Visualized Accurately|Participants||Number
2794590|NCT00558753|Secondary|Knee Range of Motion (Active Flexion)||1-30 days||||Degrees||Standard Error|Least Squares Mean
2794591|NCT00558753|Secondary|Neuropathic Pain (S-LANSS > 12)|Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician's office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation.|3 and 6 months post-surgery||||participants|||Number
2794592|NCT00558753|Primary|Epidural Medication Consumption Rate|Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.|36 h|Because of structural missing data, sample sizes are smaller than the samples size for the secondary measure.|||mL/h||Standard Deviation|Mean
2794593|NCT00558701|Primary|Time to Wound Healing|Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing|20 days||||days||Full Range|Mean
2794594|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.|||Units on a scale||Standard Deviation|Mean
2794595|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.|||units on a scale||Standard Deviation|Mean
2794596|NCT00558636|Secondary|Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2|"The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from not at all to very much. The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms."|Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 90 completed the LCS at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the response rate (number of evaluable subjects completing the questionnaire) decreased from cycle to cycle and makes the results hard to interpret.|||units on a scale||Standard Deviation|Mean
2794597|NCT00558636|Secondary|Duration of Response|Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated.|Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient.|All subjects that showed a response. Since only 4 subjects had a response, the data were not analyzed.|||days|||Number
2794617|NCT00558571|Secondary|Cmax of Empagliflozin|maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28|Pharmacokinetic (PK) analysis set: comprised all 62 patients who received Empagliflozin and had evaluable PK parameter data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2794598|NCT00558636|Secondary|Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions.|Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient.|All randomized subjects (the intent to treat (ITT) population) were included in the analysis.|||Participants|||Number
2794599|NCT00558636|Secondary|Overall Survival (OS)|"Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|All randomized subjects (the intent to treat (ITT) population) were included in the analysis. Since 89% of subjects were censored, OS could not be calculated. The number of subjects who Failed (died) or were Censored are reported.|||Participants|||Number
2794600|NCT00558636|Primary|Progression Free Survival|"Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|It was intended to include all randomized subjects (the intent to treat (ITT) population) in the analysis. Since 89% of subjects were censored, PFS could not be calculated. The number of subjects who Failed (progressed or died before progression) or were Censored are reported.|||Participants|||Number
2794601|NCT00558571|Secondary|HbA1c|change from baseline on day 28. Baseline is defined as day -1.|in the morning of days -1 and 28|PD analysis set|||percentage of hemoglobin||Standard Deviation|Mean
2794602|NCT00558571|Secondary|Fructosamine|change from baseline to days 14 and 18. Baseline is defined as day -1.|day -1 (baseline), 14 and 28|PD analysis set|||µmol/L||Standard Deviation|Mean
2794603|NCT00558571|Secondary|Glucagon AUEC0-5|Change from baseline (day -1) in AUEC0-5 on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Pharmacodynamic (PD) analysis set: All patients who receive at least one dose of study medication (active drug or placebo) and had some PD data were included in the pharmacodynamic analysis.|||ng*h/L||Standard Deviation|Mean
2794604|NCT00558571|Secondary|Glucagon Emax (Maximum Measured Effect)|Change from baseline (day -1) in Emax on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set|||ng/L||Standard Deviation|Mean
2794605|NCT00558571|Secondary|Fasting Insulin|Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.|in the morning of days -1( baseline), 1, 7, 14, 21 and 28|PD analysis set|||µU/mL||Standard Deviation|Mean
2794606|NCT00558571|Secondary|Insulin Emax (Maximum Measured Effect)|change in Emax from baseline on day 28. Baseline is defined as day -1|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set|||µU/mL||Standard Deviation|Mean
2794607|NCT00558571|Secondary|Insulin AUEC0-5|change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set|||µU*h/mL||Standard Deviation|Mean
2794608|NCT00558571|Secondary|Mean Daily Glucose (MDG) Measured in Blood|change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27|PD analysis set|||mg/dL||Standard Deviation|Mean
2794609|NCT00558571|Secondary|Fasting Plasma Glucose (FPG)|fasting plasma glucose on day -1 (baseline) and change from baseline to day 28|in the morning of days -1 and 28|PD analysis set|||mg/dL||Standard Deviation|Mean
2794610|NCT00558571|Secondary|Ae0-24 of Glucose|Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)|Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h|PD analysis set|||mg||Geometric Coefficient of Variation|Geometric Mean
2794611|NCT00558571|Secondary|LI (Linearity Index).|The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28|PK analysis set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2794612|NCT00558571|Secondary|fe0-24 of Empagliflozin|Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set for patients who have fe data at day 1 and day 28|||percentage of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
2794613|NCT00558571|Secondary|CL/F of Empaglifozin|apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2794614|NCT00558571|Secondary|AUC0-∞ of Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1|PK analysis set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2794625|NCT00558519|Primary|Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)|The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below.|Up to 10 years post-registration||||Participants|||Count of Participants
2794626|NCT00558519|Primary|Overall Survival|OS was defined from registration to death resulting from any cause.|Up to 8 years post-registration||||months||95% Confidence Interval|Median
2794627|NCT00558519|Primary|Disease-free Survival|DFS was defined as time from bone marrow response in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.|Up to 8 years post-registration||||months||95% Confidence Interval|Median
2794628|NCT00558519|Primary|Event-free Survival|EFS was defined as time from registration in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.|Up to 8 years post-registration||||months||95% Confidence Interval|Median
2794629|NCT00558519|Primary|Complete Response Rate|Complete response rate is defined as the percentage of patients who achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) at the end of induction therapy.|Up to 8 years post-registration||||percentage of patients||95% Confidence Interval|Number
2794630|NCT00558467|Secondary|Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.||baseline and Week 6|Full Analysis Set (FAS).|||participants|||Number
2794631|NCT00558467|Secondary|Patient Global Impression at Week 6|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794632|NCT00558467|Secondary|Patient Global Impression at Week 4|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794633|NCT00558467|Secondary|Patient Global Impression at Week 3|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794634|NCT00558467|Secondary|Patient Global Impression at Week 2|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794635|NCT00558467|Secondary|Patient Global Impression at Week 1|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794636|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 6|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794637|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 4|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794638|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 3|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794639|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 2|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794640|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 1|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794641|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 6|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794642|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 4|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794643|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 3|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794644|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 2|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794645|NCT00558467|Secondary|Clinical Global Impressions - Improvement at 1 Week|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).|||Number of Patients|||Number
2794646|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794647|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794648|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794649|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794650|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 6 weeks|The Full Analysis Set with last observation carried forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
2794651|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794652|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794653|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794654|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.|||score on a scale||Standard Deviation|Mean
2794655|NCT00558467|Primary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale|"Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.~Analysis was adjusted for baseline total tic score and age as linear covariates."|baseline 6 weeks|The Full Analysis Set (FAS) with last observation carried forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
2794656|NCT00558428|Primary|Number of Patients With Oedema|Patients from the treated set who experienced at least one case of general oedema.|During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)|The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097)|||patients|||Number
2794657|NCT00558428|Secondary|Trough Seated Blood Pressure (BP) Normality Classes|"The number of patients who reach predefined BP categories:~Optimal - SBP<120 and DBP<80 mmHg~Normal - SBP<130 and DBP<85 mmHg~High-normal - SBP<140 DBP<90 mmHg~Stage 1 hypertension - SBP<160 and DBP<100~Stage 2 hypertension SBP>=160 and DBP>=100 mmHg"|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
2794658|NCT00558428|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
2794659|NCT00558428|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
2794660|NCT00558428|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
2794661|NCT00558428|Secondary|Trough Seated Diastolic Blood Pressure Control|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||patients|||Number
2794662|NCT00558428|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)|Change from baseline to the end of study in trough SBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||mmHg||Standard Error|Least Squares Mean
2794663|NCT00558428|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline to the end of study in trough DBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure|||mmHg||Standard Error|Least Squares Mean
2794664|NCT00558363|Secondary|Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline|Threshold vital signs are defined as follows: < 80 mmHg or > 165 mmHg for systolic blood pressure; < 40 mmHg or > 105 mm Hg for diastolic blood pressure, < 40 beats per minute (bpm) or > 100 bpm for heart rate.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one vital sign parameter were excluded from this analysis (6 in placebo arm, 4 in dutasteride arm).|||participants|||Number
2794665|NCT00558363|Secondary|Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline|Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.|Baseline; up to 28 months|ITT Population|||participants|||Number
2794666|NCT00558363|Secondary|Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with NT at baseline or NT at any time post-baseline were measured for clinical significance.|||participants|||Number
2794667|NCT00558363|Secondary|Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with PBT at baseline or PBT at any time post-baseline were measured for clinical significance.|||participants|||Number
2794668|NCT00558363|Secondary|Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline|Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one laboratory parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).|||participants|||Number
2795115|NCT00555750|Secondary|Change in Total Sleep Time Measured by PSG|Change (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo|baseline and 2 months post-treatment||||minutes||Standard Deviation|Mean
2794669|NCT00558363|Secondary|Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study|A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.|Baseline; up to 28 months|ITT Population. Participants not having any baseline measurements, or having a baseline but no post-baseline measurements of at least one of the same parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).|||participants|||Number
2794670|NCT00558363|Secondary|Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)|MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.|Baseline; Months 3, 6, 12, 18, and 24|ITT Population. Participants not having a baseline value or not having any post-baseline value could not be evaluated for this endpoint and were hence excluded from this analysis (3 in placebo arm, 4 in dutasteride arm). Participants were excluded from a specific visit analysis if the value for the visit (after LOCF application) was missing.|||scores on a scale||Standard Error|Least Squares Mean
2794671|NCT00558363|Secondary|Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)|Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.|Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)|ITT Population. Participants having no baseline (BL) PSADT (due to incomplete PSA data or no rise in PSA at BL) or no post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 3 in dutasteride arm). Participants with missing PSA data at a specific visit were excluded from that visit’s analysis .|||participants|||Number
2794672|NCT00558363|Secondary|Percent Change in PSA From Nadir PSA at Months 12 and 24|Percent change from nadir PSA at Month X = 100*(Month X PSA - nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||percent change||Standard Deviation|Mean
2794673|NCT00558363|Secondary|Change in PSA From Nadir PSA at Months 12 and 24|Change from nadir PSA at Month X = Month X PSA - nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||ng/ml||Standard Deviation|Mean
2794674|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline During Year 1|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
2794675|NCT00558363|Primary|Time to PSA Doubling From Baseline (in Days) Within Year 1|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Only participants with PSA doubling within Year 1 (50 in placebo, 15 in dutasteride) contributed to summary statistics.|||days||Full Range|Median
2794676|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
2794677|NCT00558363|Secondary|Percent Change in Total PSA From Baseline at Months 12 and 24|Percent change in PSA from baseline at Month X = 100*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||percent change||Standard Deviation|Mean
2794678|NCT00558363|Secondary|Change in Total PSA From Baseline at Months 12 and 24|Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||nanograms/milliliter (ng/ml)||Standard Deviation|Mean
2794679|NCT00558363|Secondary|Number of Participants With PSA Progression|A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (>10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy) and PSA >=1.5 times the baseline PSA value), or 0<PSADT<=91 days, and all subsequent PSA values satisfied either of these criteria.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
2794680|NCT00558363|Secondary|Time to PSA Progression (in Days)|A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy and PSA >=1.5 times the baseline PSA value, or 0<PSADT<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA progression have been summarized.|||days||Full Range|Median
2794681|NCT00558363|Secondary|Number of Participants With a PSA Rise From Baseline|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
2794682|NCT00558363|Secondary|Time to PSA Rise From Baseline (in Days)|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA rise have been summarized.|||days||Full Range|Median
2794683|NCT00558363|Secondary|Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24|Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase <=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.|Months 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Par. not having a post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Different par. may contribute data at different time points (TP); the number of par. analyzed at each TP are those with BL as well as post-baseline data at the particular TP.|||participants|||Number
2794684|NCT00558363|Secondary|Number of Participants With Disease Progression|Disease progression is defined as the first occurrence of any of the following: PSADT<=91 days, PSA value is at least 50% more than baseline value (>20 ng/ml for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).|||participants|||Number
2794685|NCT00558363|Secondary|Time to Disease Progression From Baseline (in Days)|Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)<=91 days, PSA value is at least 50% more than baseline value (>20 nanogram/milliliter [ng/ml] for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)|up to 28 months|ITT Population. Only those participants with disease progression have been summarized.|||days||Full Range|Median
2794686|NCT00558363|Primary|Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.|up to 28 months|ITT Population: all participants randomized to study treatment. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm; 1 in dutasteride arm). Only participants who experienced PSA doubling (82 in placebo, 41 in dutasteride) contributed to summary statistics.|||days||Full Range|Median
2794687|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 14|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
2794688|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 7|The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 7|Safety Population includes all patients who received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
2794689|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 1|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
2794690|NCT00558285|Secondary|Trough Forced Vital Capacity (FVC) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Day 1 and Day 14|Participants from the Intent-to-treat Population (all randomized patients) with data available at the given time-point. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.|||Liters||Standard Error|Least Squares Mean
2794691|NCT00558285|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Day 1, Day 14|Intent-to-treat Population includes all randomized patients. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.|||Liters||Standard Error|Least Squares Mean
2794692|NCT00558285|Secondary|Change From Baseline in Mean 24 Hour Heart Rate at Day 1|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.|||beats per minute||Standard Error|Least Squares Mean
2794693|NCT00558285|Primary|Change From Baseline in Mean 24 Hour Heart Rate at Day 14|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.|||beats per minute||Standard Error|Least Squares Mean
2794694|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||h||Full Range|Median
2794695|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||Ratio||Full Range|Median
2794696|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
2794697|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
2794698|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng.h/ml||Full Range|Median
2794699|NCT00558272|Secondary|Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||h||Full Range|Median
2794700|NCT00558272|Secondary|Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
2794701|NCT00558272|Secondary|Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng/ml||Full Range|Median
2794702|NCT00558272|Secondary|Saracatinib: Plasma Clearance at Steady State (CLss/F)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||L/h||Full Range|Median
2794715|NCT00558259|Secondary|Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period|Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.|||Participants|||Number
2794703|NCT00558272|Secondary|Saracatinib: Area Under the Curve at Steady State (AUCss)|Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.|Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29||||ng•hr/ml||Full Range|Median
2794704|NCT00558272|Secondary|Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in aaCTx/Cr||95% Confidence Interval|Geometric Mean
2794705|NCT00558272|Secondary|Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in NTx/Cr||95% Confidence Interval|Geometric Mean
2794706|NCT00558272|Secondary|Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in TRAP5b||95% Confidence Interval|Geometric Mean
2794707|NCT00558272|Secondary|Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in PINP||95% Confidence Interval|Geometric Mean
2794708|NCT00558272|Secondary|Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in ICTP||95% Confidence Interval|Geometric Mean
2794709|NCT00558272|Secondary|Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in bALP||95% Confidence Interval|Geometric Mean
2794710|NCT00558272|Primary|Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.|||Percentage change in betaCTX||95% Confidence Interval|Geometric Mean
2794711|NCT00558259|Secondary|Laboratory Measures, Especially Liver Function Tests (LFTs)|Number of participants with possible clinically significant abnormalities during the treatment period.|6 months|FAS − As Treated Assignment|||participants|||Number
2794712|NCT00558259|Secondary|Centrally Confirmed Cardiovascular Events During the Treatment Period|Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.|||participants|||Number
2794713|NCT00558259|Secondary|Centrally Confirmed Bleeding Event During the Treatment Period|"Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:~Fatal bleeding~Associated with a fall in haemoglobin of ≥2 g/dL~Led to the transfusion of ≥2 units packed cells or whole blood~Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal~Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.~Examples of these bleedings were:~Bleeding that compromised haemodynamics~Bleeding that led to hospitalisation~Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.~All bleeding events include MBEs, CRBEs, and trivial bleeding events."|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.|||participants|||Number
2794716|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period|Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.|||Participants|||Number
2794717|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|FAS and analysed as randomised.|||Participants|||Number
2794718|NCT00558259|Primary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.|||Participants|||Number
2794719|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85."|12 months|There were 59 participants who completed all follow-up visits and cosmetic evaluations.|||Incisions with good outcome|||Number
2794720|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85."|6 months|There were 60 participants who completed all follow-up visits and cosmetic evaluations.|||Incisions with good outcome|||Number
2794721|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85."|90 days post-procedure|There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcome|||Number
2794722|NCT00558246|Secondary|Time (Minutes) Required to Close the Final Skin Layer|Overall time required to close final skin layer on each breast.|Intraoperative|The analysis is based upon the Intent to Treat population.|||minutes||Standard Deviation|Mean
2794723|NCT00558246|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent.|12-25 days|The primary analysis is based upon intent to treat population.|||Participants|||Number
2794724|NCT00558103|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks|mITT1 and mITT2 Populations|||months||90% Confidence Interval|Median
2794725|NCT00558103|Secondary|Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks|mITT1 and mITT2 Populations|||weeks||90% Confidence Interval|Median
2794726|NCT00558103|Secondary|Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks|mITT1 and mITT2 Populations. Only participants who achieved a response of CR or PR during the study were analyzed. For participants who did not progress or die, duration of response was censored on the date of the last adequate assessment.|||weeks||90% Confidence Interval|Median
2794739|NCT00558025|Secondary|Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)|Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||participants|||Number
2795649|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients|||Participants|||Number
2794727|NCT00558103|Primary|Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions|RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study treatment. The mITT1 Population was used for cohort 1; the mITT2 Population used for cohort 2.|||participants|||Number
2794728|NCT00558064|Secondary|Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period.|||participants|||Number
2794729|NCT00558064|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg~No: SBP >= 140 mmHg and DPB >= 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
2794730|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
2794731|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
2794732|NCT00558064|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
2794733|NCT00558064|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of patients|||Number
2794734|NCT00558064|Secondary|Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
2794735|NCT00558064|Primary|Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
2794736|NCT00558025|Secondary|Final Pramipexole Dose (mg) After 9 Weeks, Treated Set|The mean final daily Pramipexole dose is displayed|Week 9|Treated Set (TS) includes all patients randomized and who received treatment|||mg||Standard Deviation|Mean
2794737|NCT00558025|Secondary|Pramipexole Dose Adaptation, FAS (LOCF)|Patients with increase in daily Pramipexole dose on FAS|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||participants|||Number
2794738|NCT00558025|Secondary|Patient Global Impression - Improvement (PGI-I), FAS (LOCF)|Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||participants|||Number
2795813|NCT00550862|Secondary|Serum Gamma-Glutamyl Transpeptidase (GGT)|Percent change in serum gamma-glutamyl transpeptidase (GGT) from baseline to Day 85/early termination.|Baseline and 12 weeks||||Percent (%) change||Standard Deviation|Mean
2794740|NCT00558025|Secondary|Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Score on Scale||Standard Error|Least Squares Mean
2794741|NCT00558025|Secondary|Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Score on Scale||Standard Error|Mean
2794742|NCT00558025|Secondary|Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Score on scale||Standard Error|Least Squares Mean
2794743|NCT00558025|Secondary|Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)|A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).|from baseline to week 4|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Percentage of participants|||Number
2794744|NCT00558025|Primary|Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)|A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|from baseline to week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint|||Percentage of participants|||Number
2794745|NCT00558012|Primary|Bone Mineral Density (BMD) of the Total Hip and Spine|BMD is the bone mineral density of the lumbar spine and total hip measured using dual-energy xray absorptiometry (DXA) scan|Baseline, 12 months, 24 month|Number of patients that completed a DXA at 12 months. At 24 months 60 in active treatment group and 72 in placebo group completed a DXA.|||Percent change||Standard Error|Mean
2794746|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85."|12 month|There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcome|||Number
2794747|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85."|6 months|There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcomes|||Number
2794748|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85."|90 days post-procedure|There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.|||Incisions with good outcome|||Number
2794749|NCT00557947|Secondary|Time Required to Close the Final Skin Layer|Time to close final skin layer for each incision segment.|Intraoperative|The analysis is based upon the Intent To Treat population|||minutes||Standard Deviation|Mean
2794750|NCT00557947|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|12-25 days post-operation|The primary analysis is based upon intent to treat population.|||Participants|||Number
2794751|NCT00557856|Other Pre-specified|Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Data was reported in individual participant listings but not statistically summarized due to statistical constraints.||||||
2794752|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
2795866|NCT00550537|Secondary|Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
2794753|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
2794754|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
2794755|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2|Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||pg/ml||Standard Deviation|Mean
2794756|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2794757|NCT00557856|Other Pre-specified|Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2|HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (>=4.32).|Baseline up to 3 months after last dose|Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification.||||||
2794758|NCT00557856|Other Pre-specified|Plasma Decay Half-Life (t1/2): Part 1 and Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||hours||Standard Deviation|Mean
2794759|NCT00557856|Secondary|Volume of Distribution: Part 1 and Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||liter (L)||Standard Deviation|Geometric Mean
2794760|NCT00557856|Other Pre-specified|Systemic Clearance(CL): Part 1 and Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||liter/hour (L/hr)||Standard Deviation|Geometric Mean
2794761|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2794974|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg*h/mL||Standard Deviation|Mean
2794762|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2|AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2794763|NCT00557856|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.|||hour||Full Range|Median
2794764|NCT00557856|Other Pre-specified|Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2||0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure and “n” signifies those participants who were evaluable at specific time-point.|||ng/mL||Standard Deviation|Geometric Mean
2794765|NCT00557856|Other Pre-specified|Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962.|||nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
2794766|NCT00557856|Secondary|Time To Progression (TTP): Part 2|Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST). PD: >=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of >=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Safety population included all participants who received at least one dose of study drug.|||months||Full Range|Median
2794767|NCT00557856|Secondary|Percentage of Participants With Disease Control: Part 2|Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment.|||percentage of participants||90% Confidence Interval|Number
2794768|NCT00557856|Secondary|Percentage of Participants With Objective Response: Part 1 and Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment.|||percentage of participants||90% Confidence Interval|Number
2794769|NCT00557856|Secondary|Number of Participants With Laboratory Abnormalities: Part 1 and Part 2|Laboratory tests included hematology (hemoglobin, lymphocytes absolute [abs], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute [NCI] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 [mild AE: did not cause any significant problem, no dose adjustment required]; grade 2 [moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event]; grade 3 [severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event] and grade 4 [life threatening AE]). Overall data of the 4 grades is reported.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2794802|NCT00557505|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng/mL||Standard Deviation|Geometric Mean
2794770|NCT00557856|Secondary|Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned.||||||
2794771|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2794772|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2794773|NCT00557856|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2794774|NCT00557856|Primary|Recommended Phase 2 Dose (RP2D): Part 1|RP2D was defined as the lower dose level to MTD based on the safety profile.|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.|||mg/kg|||Number
2794775|NCT00557856|Primary|Maximum Tolerated Dose (MTD): Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.|||milligram/kilogram (mg/kg)|||Number
2794776|NCT00557830|Post-Hoc|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever occurred first||||Months||95% Confidence Interval|Median
2794777|NCT00557830|Secondary|Changes From Baseline in Symptom Burden|"The Patient Care Monitor Version 2.0 (PCM) is an tablet computer based assessment system that measures patient reported outcomes (PROs) in medical patients with a particular emphasis on symptoms related to cancer and its treatment.~The PCM comprises 86 items which include 8 items answered only by females (e.g. menstrual cramping). Each item is presented so that the patient rates the degree to which the item has been a problem in the past week (0 not a problem to 10 as bad as possible)."|The PCM was administered during screening, at each scheduled visit (approximately every 4 weeks), and at the end of treatment visit.||||units on a scale||Standard Deviation|Mean
2794778|NCT00557830|Secondary|Overall Survival Rate|Due to the early study closure and the small sample size, overall survival rate was not evaluated.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 4 months thereafter until death.|Due to the early study closure and the small sample size, overall survival rate was not evaluated.||||||
2794779|NCT00557830|Secondary|PFS Rate at 9, 13 and 17 Months|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.|PFS was to be measured at 9, 13, and 17 months.|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.||||||
2794800|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]|AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng*hr/mL||Standard Deviation|Geometric Mean
2794780|NCT00557830|Primary|Overall Response Rate (CR + PR) Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Response was evaluated via changes from baseline in radiological tumor measurements performed every 8 weeks and at the end of treatment unless clinically indicated prior to that. Confirmatory scans were to be obtained no less than 4 weeks but no more than 6 weeks following initial documentation of objective response. Response was evaluated using RECIST criteria, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions or the appearance of one or more new lesions.|Overall response will be measured at baseline and every 8 weeks , unless clinically indicated prior to that, until the end of treatment.||||Participants|||Number
2794781|NCT00557622|Secondary|Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1,Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse.|Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794782|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CGI (Clinical Global Impression) Severity of Illness Scores at Weeks 2, 4, 6, 8, 10, and 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794783|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Increased Arousal Symptom at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794784|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Avoidance and Numbing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794785|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Re-experiencing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794786|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Total Score at Weeks 4 and 8|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4 and 8|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794801|NCT00557505|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng/mL||Standard Deviation|Geometric Mean
2794787|NCT00557622|Secondary|Number of Participants With the Indicated Week 0 and Week 12 Z-scores for Regional Blood Flow Using Functional Magnetic Resonance Imaging (fMRI) in the Left Amygdala (LA), Right Amygdala (RA), and the Medial Prefrontal Cortex (MPFC)|Change in regional blood flow (rCBF) measured by fMRI represents altered neuronal responses in PTSD patients and is considered to be the biomarker for treatment response. fMRI measures are provided as blood oxygeneration level-dependent (BOLD) signals (z-score). To trigger neuronal activation, 2 visual stimuli were used: MVA-task (consisting of MVA-related and unpleasant pictures) and face-task (consisting of a variety of facial expressions [e.g., neutral, happy, fear]). Week 0 and 12 rCBF data from 1 participant were invalid (involuntary movement in the fMRI machine); no analysis was done.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794788|NCT00557622|Primary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale One Week Symptom Status Version) Total Score at Week 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.|||participants|||Number
2794789|NCT00557505|Other Pre-specified|Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)||Baseline and cycle 3|Data was not analyzed, as development of the compound was terminated.|||pg/mL||Standard Deviation|Mean
2794790|NCT00557505|Other Pre-specified|Change From Baseline in Cytokine Concentration||Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1|Data was not analyzed, as development of the compound was terminated.|||picogram (pg)/mL||Standard Deviation|Mean
2794791|NCT00557505|Other Pre-specified|Change From Baseline in Leucocyte Subtypes||Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.|||cells/mL|||Number
2794792|NCT00557505|Other Pre-specified|Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood||Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.|||cells/mL|||Number
2794793|NCT00557505|Other Pre-specified|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.|||weeks||Full Range|Median
2794794|NCT00557505|Other Pre-specified|Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)||Baseline, cycle 3 and after 8 weeks|Data was not analyzed, as development of the compound was terminated.|||standardized uptake value (SUV)||Standard Deviation|Mean
2794795|NCT00557505|Other Pre-specified|Human Anti-Human Antibody (HAHA) Levels|HAHA are indicators of immunogenicity to PF-03732010.|Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal|Data was not analyzed, as development of the compound was terminated.|||microgram/mL||Standard Deviation|Mean
2794796|NCT00557505|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.|||participants|||Number
2794797|NCT00557505|Secondary|Apparent Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||Liter||Standard Deviation|Geometric Mean
2794798|NCT00557505|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||Liter/hr||Standard Deviation|Geometric Mean
2794799|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||ng*hr/mL||Standard Deviation|Geometric Mean
2796678|NCT00546078|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|At Day 7 and at Month 1 (Day 30)|Analysis was performed on the ATP cohort for immunogenicity.|||titer||95% Confidence Interval|Geometric Mean
2794803|NCT00557505|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||hr||Full Range|Median
2794804|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]|AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2794805|NCT00557505|Primary|Recommended Phase-2 Dose (RP2D)||Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle|Data was not analyzed, as development of the compound was terminated.|||mg/kg|||Number
2794806|NCT00557505|Primary|Maximum Tolerated Dose (MTD)||Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle|MTD analysis population included all participants enrolled in the dose escalation part of the study who received at least 1 dose of study medication.|||mg/kg|||Number
2794807|NCT00557492|Secondary|Ca 19-9 Level (in Serum) - Biomarker Response|Percentage decrease in Ca 19-9 level (in serum)|Baseline and up to 48 months|Participants that did NOT demonstrate metastatic progression upon restaging CT.|||percentage decrease in serum Ca19-9 leve||Standard Deviation|Mean
2794808|NCT00557492|Secondary|Radiographic Tumor Response|CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)|Up to 48 months||||Participants|||Number
2794809|NCT00557492|Secondary|Rate of Surgical Resection|Number of participants that underwent resection / per the total number of evaluable participants|Up to 48 months||||percentage of participants|||Number
2794810|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.|||months||95% Confidence Interval|Median
2794811|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes entire study cohort.|||months||95% Confidence Interval|Median
2794812|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.|||months||95% Confidence Interval|Number
2794813|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes entire study cohort.|||months||95% Confidence Interval|Number
2794814|NCT00557492|Primary|Rate of Pathologic Complete Response (pCR)|Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resections.|||percentage of participants||95% Confidence Interval|Number
2794815|NCT00557492|Primary|Rate of Margin Negative Surgical Resection (R0 Resection Rate)|Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resection.|||percentage of participants||95% Confidence Interval|Number
2794816|NCT00557466|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat|||participants|||Number
2794817|NCT00557466|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period).|Intent to treat population. The analysis only includes patients with non-missing data.|||liters/minute||Standard Deviation|Mean
2794818|NCT00557466|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."|||minutes||Standard Deviation|Mean
2794819|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
2794820|NCT00557466|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
2794821|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
2794822|NCT00557466|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
2794823|NCT00557440|Secondary|Forced Vital Capacity (FVC) at Single Time Points|"Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC was analyzed using ANCOVA adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.|||liters||Standard Error|Least Squares Mean
2794824|NCT00557440|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1 during the first 4 hours post-dose.~Time to peak FEV1 is based on log-transformed analysis of variance adjusted for treatment, period, sequence and center, with patient nested within sequence as a random effect. Geometric Mean was obtained by taking anti-logs of the adjusted means from the model and standard error was calculated using the delta method."|Up to 4 hours post-dose|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis.|||minutes||Standard Error|Geometric Mean
2794825|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was measured pre-dose and up to 24 hours post-dose. The FEV1 standardized area under the curve (AUC) was analyzed for four time intervals:~Baseline (pre-dose) to 4 hours (hr) post-dosing;~Baseline (pre-dose) to 23 hours, 45 minutes (min) post-dosing;~11 hours, 10 minutes to 12 hours, 30 minutes post-dosing;~11 hours, 10 minutes to 23 hours, 45 minutes post-dosing.~AUC for FEV1 was analyzed using Analysis of Covariance adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|Pre-dose, 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.|||liters||Standard Error|Least Squares Mean
2794826|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.|||liters||Standard Error|Least Squares Mean
2794827|NCT00557440|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|The Intent-To-Treat (ITT) population included all randomized patients who had at least one period containing a Baseline FEV1 measurement and at least one post-baseline measurement of FEV1 for the same treatment period. Patients who took rescue medication within 6 hours prior to the trough measurements were excluded from the analysis.|||liters||Standard Error|Least Squares Mean
2794828|NCT00557362|Secondary|Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate|Best hard contact lens-corrected visual acuity 3 months after enrollment was evaluated in a multiple linear regression model with enrollment hard contact lens-corrected visual acuity as a covariate. Visual acuity is reported in logMAR (logarithm of the Minimum Angle of Resolution).|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
2794843|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/square centimeter (g/cm²)||Standard Error|Least Squares Mean
2794829|NCT00557362|Secondary|Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).|Two subgroup analyses were conducted by causative organism: 1) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Fusarium ulcers; 2) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Aspergillus ulcers.|3 months from enrollment|This analysis looks at two different subgroups - Fusarium ulcers and Aspergillus ulcers. There were 44 Fusaruim ulcers enrolled in this trial and analyzed here, 23 of which were randomized to voriconazole and 21 to natamycin. There were 19 Aspergillus ulcers analyzed here, 8 of which were randomized to voriconazole and 11 to natamycin.|||logMAR||95% Confidence Interval|Mean
2794830|NCT00557362|Secondary|Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.|Size of infiltrate/scar post-treatment was analyzed in a linear regression model using enrollment infiltrate/scar size as a covariate. No differentiation was made between infiltrate and scar when measuring infiltrate/scar size (measured in mm). For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular.|3 months from enrollment||||mm||95% Confidence Interval|Mean
2794831|NCT00557362|Secondary|Time to Resolution of Epithelial Defect|Resolution of epithelial defect was defined as the absence of an epithelial defect with administration of fluorescein. The time to re-epithelialization was compared between the voriconazole and natamycin groups using the Cox proportional hazards model, adjusting for baseline epithelial defect size.|3 months from enrollment||||days||Standard Deviation|Mean
2794832|NCT00557362|Primary|Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model|The primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
2794833|NCT00557349|Secondary|Number of Participants With Upper Endoscopy Indicated Due to Complaints|Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints|during first 14 weeks after surgery|Patients lost to follow-up were not included in the study analysis.|||participants|||Number
2794834|NCT00557349|Primary|Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.||during first 14 weeks after surgery|Patients lost to follow-up were not included in the data analysis.|||participants|||Number
2794835|NCT00557323|Secondary|Number of Study-emergent Deaths||5 years|Safety Set|||Participants|||Number
2794836|NCT00557323|Primary|Number of Study-emergent Bone-related Adverse Events (AEs)||5 years|Safety Set defined as all subjects who received at least one safety measurement during the study.|||Bone-related AEs|||Number
2794837|NCT00557310|Secondary|Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint|CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of nanogram/milliliter (ng/mL)||Standard Error|Least Squares Mean
2794838|NCT00557310|Secondary|Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint|PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of microgram/Liter (µg/L)||Standard Error|Least Squares Mean
2794839|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
2794840|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
2794841|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
2794842|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of g/cm²||Standard Error|Least Squares Mean
2794999|NCT00556504|Secondary|Virologic Response|"undetectable HCV RNA at the end of combination drug treatment~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)."|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
2794844|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of Newtons||Standard Error|Least Squares Mean
2794845|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of Newtons||Standard Error|Least Squares Mean
2794846|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of mg/cm³||Standard Error|Least Squares Mean
2794847|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of mg/cm³||Standard Error|Least Squares Mean
2794848|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 12, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
2794849|NCT00557310|Secondary|Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint|BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
2794850|NCT00557310|Secondary|Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint|TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
2794851|NCT00557310|Secondary|Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint|Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of millimeter (mm)||Standard Error|Least Squares Mean
2794852|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||% change of ratio||Standard Error|Least Squares Mean
2794853|NCT00557310|Primary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.|||percent (%) change of ratio||Standard Error|Least Squares Mean
2794898|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2794854|NCT00557284|Secondary|Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS|The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
2794855|NCT00557284|Primary|Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream|Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).|Baseline and 9 weeks||||days/week||Standard Deviation|Mean
2794856|NCT00557284|Primary|Mean Change in Pruritus|"Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments (itch) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week."|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
2794857|NCT00557284|Primary|Mean Change in PADC (Caregivers Perception of Disease Control)|Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver's evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
2794858|NCT00557284|Primary|Mean Change in Investigator Global Assessment (IGA)|The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.|Baseline and 9 weeks||||units on a scale||Standard Deviation|Mean
2794859|NCT00557284|Primary|Change in Percentage of Body Involvement|Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator|Baseline and 9 weeks||||Change of percentage in body involvement||Standard Deviation|Mean
2794860|NCT00557284|Secondary|Mean Change in Serum IgE Levels|Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.|Baseline and 9 weeks||||kU/L||Standard Deviation|Mean
2794861|NCT00557284|Secondary|Mean Change in Serum and Urinary Inflammatory Marker Levels|Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)|Baseline and 9 weeks||||pg/ml||Standard Deviation|Mean
2794862|NCT00557245|Secondary|Head Circumference Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up|||z-score difference per study month|||Number
2794863|NCT00557245|Secondary|Weight Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up|||z-score difference per study month|||Number
2794864|NCT00557245|Secondary|Length Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up|||z-score difference per study month|||Number
2794865|NCT00557245|Secondary|Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.|Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.|Up to 36 months|Randomized female participants, less those found to be ineligible (n=7)|||Number of live-born infants|live-born infants||Number
2794866|NCT00557245|Secondary|Prevalence of Unprotected Sex During Follow-up|Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.|Up to 36 months|All randomized participants, less those found to be ineligible (n=11).|||percentage of visits|||Number
2794867|NCT00557245|Secondary|Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up|"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)."|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)|||participants|||Number
2794918|NCT00556933|Secondary|Ratio of CD4/CD8 Lymphoid Cells||One year||||Ratio of cell counts||Standard Deviation|Mean
2794919|NCT00556933|Secondary|New-onset Diabetes and Hyperglycemia After Transplantation (NODAT)||Six months||||participants|||Number
2794868|NCT00557245|Secondary|Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC|"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)."|Up to 36 months|Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing.|||Participants|||Number
2794869|NCT00557245|Secondary|Study Drug Adherence: Self-reported Missed Doses of Study Drug|Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.|Up to 36 months|Participants with self-reported adherence.|||percentage of visits|||Number
2794870|NCT00557245|Secondary|Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.|Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.|Up to 36 months||||percentage of doses taken of dispensed|||Number
2794871|NCT00557245|Primary|Number of Participants With Serious Adverse Events (SAEs)|Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)|||Participants|||Number
2794872|NCT00557245|Primary|Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants|The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.|Up to 36 months|All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25).|||events per 100 person years||95% Confidence Interval|Number
2794873|NCT00557193|Secondary|Percent Probability for Event-free Survival (EFS) for Patients on Arm A|EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.|From start of post-induction therapy for up to 10 years|All Eligible patients treated in Arm A (standard risk MLL-G).|||percentage probability||90% Confidence Interval|Number
2794874|NCT00557193|Secondary|Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values|Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype|At 3 years|Data was and never will be collected||||||
2794875|NCT00557193|Secondary|Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With Survival Outcomes|EFS outcomes will be reported by genotype.|At 3 years|Data was and never will never be collected.||||||
2794876|NCT00557193|Secondary|Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm|Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status.|3 Years from end of Induction)|Patients who had data collected|||percent probability||90% Confidence Interval|Number
2794877|NCT00557193|Secondary|Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts|Described via means and standard deviations in samples which have acquired resistance to lestaurtinib|At relapse (up to 3 years)|Arm C Dose Level 2 patients who relapsed and had data collected|||Proportion of cells that are viable||Standard Deviation|Mean
2794878|NCT00557193|Secondary|Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts|Described via means and standard deviations in samples which have primary resistance to lestaurtinib|Sampled at the start of induction|Patients who had data collected|||Proportion of cells that are viable||Standard Deviation|Median
2794879|NCT00557193|Secondary|Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts|Described via means and standard deviations in available Arm C relapse samples|At relapse (up to 3 years)|Arm C Dose Level 2 patients who relapsed and had data collected.|||qPCR fold expression ratio||Standard Deviation|Mean
2794880|NCT00557193|Secondary|Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts|Described via mean and standard deviation by group.|Sampled at the start of induction|Patients who had data collected|||qPCR fold expression ratio||Standard Deviation|Mean
2794881|NCT00557193|Secondary|Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy|Summarized with mean and standard deviation for those with available data in Arm C|Sampled between weeks 6-12 from start of induction|Arm C Dose Level 2 (DL2) patients who had data available for analysis.|||Activity percentage||Standard Deviation|Mean
2794882|NCT00557193|Secondary|Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy|Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.|Up to 12 weeks|Data was and never will be collected||||||
2794883|NCT00557193|Secondary|Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy|Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.|Up to 12 weeks|Data was and never will be collected||||||
2794884|NCT00557193|Secondary|Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)|Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.|Up to 12 weeks from start of induction|Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.|||Participants|||Count of Participants
2794885|NCT00557193|Secondary|Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2|Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.|From start of post-induction therapy for up to 10 years.|All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.|||percent probability||90% Confidence Interval|Number
2794886|NCT00557193|Primary|Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)|EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.|From start of post-induction therapy for up to 10 years|All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.|||percentage probability||90% Confidence Interval|Number
2794887|NCT00557076|Secondary|Coma Near Coma Scale|The CNC scale measures arousal and awareness and test stimuli are administered to elicit a specified behavior. Presence/absence of this behavior is scored as 0, 2 or 4. Total raw scores range from 0 (consistently responsive) to 36 (extreme coma). The CNC change score was calculated as the 8th CNC measure minus the Baseline CNC measure. Since 2 CNC measurements were collected per week, the 8th CNC measure occurred in Week 4. To calculate the change, we used the eighth CNC measure because two patients (one per group) recovered full consciousness after the eighth CNC measure. In the second statistical analysis, all CNC measures were used to calculate the slope; this includes the Baseline CNC and CNC measures 2-8. Again, we used the first 8 CNC measures (instead of all 12 collected over 6 weeks of treatment) because two patients recovered full consciousness after the eighth CNC measure.|Baseline and after the 8th CNC assessment (4 weeks after Baseline)||||units on a scale||Standard Deviation|Mean
2794888|NCT00557076|Primary|DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change|The primary outcome, the DOCS, is a reliable, valid and precise measure of global neurobehavioral functioning shown to remain stable over six weeks.The DOCS-25 starts with a systematic observation followed by administration of 25 sensory stimuli. Best responses to each stimulus are rated on a scale of 0 to 2 and total raw scores range from 0 (worst) to 50 (best). The DOCS change was calculated as the value at endpoint (6 weeks after Baseline) minus the value at Baseline.|Baseline and immediately after treatment ends (6 weeks after Baseline)||||units on a scale||Standard Deviation|Mean
2794889|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing|||||||
2794890|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing|||||||
2794891|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of Intravenous dosing|||||||
2794892|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1|||||||
2794893|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 oral dosing|||||||
2794894|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 Oral dosing|||||||
2794895|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of IV dosing|||||||
2794896|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1|||||||
2794897|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2794899|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2794900|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Full Range|Median
2794901|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2794902|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2794903|NCT00556998|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.|||μg/mL||Standard Deviation|Geometric Mean
2794904|NCT00556998|Secondary|Cmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2794905|NCT00556998|Secondary|Tmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2794906|NCT00556998|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2794907|NCT00556998|Primary|Tmax Following Oral Administration||Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2794908|NCT00556998|Primary|Cmax,ss Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2794909|NCT00556998|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2794910|NCT00556998|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
2794911|NCT00556998|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
2794912|NCT00556998|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
2794913|NCT00556972|Secondary|What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?||After application of product||||Pouche and Bag|Participants||Number
2794914|NCT00556972|Secondary|Assessment of Skin 0-2 Inches From the Edge of the Anus|Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.|Subjects were evaluated before and after test|ITT|||Scores on a scale||Standard Deviation|Mean
2794915|NCT00556972|Secondary|Is the Barrier Size and Shape Satisfactory|Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory|Subjects were followed for the duration of the study, an average of 23 hours|ITT|||Percentage of subjects|||Number
2794916|NCT00556972|Primary|The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)||5 days|ITT|||Hours||Standard Deviation|Mean
2794917|NCT00556946|Primary|Blanching of Port Wine Stain Birthmark||12 weeks||||participants|||Number
2794929|NCT00556933|Primary|Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).|Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (<5%; none or minimal), 1 (>5% - <25%; mild), 2 (>25% - <50%, moderate), or 3 (>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher's exact test.|Two years||||percentage of participants|||Number
2794930|NCT00556894|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters|ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses|12 weeks|||||||
2794931|NCT00556894|Primary|ACR20 at Week 12|Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria|12 weeks||||participants|||Number
2794932|NCT00556712|Secondary|Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
2794933|NCT00556712|Secondary|Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
2794934|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)|"Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS|||percentage of participants||95% Confidence Interval|Number
2794935|NCT00556712|Secondary|Time to Deterioration in QoL (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS|||weeks||95% Confidence Interval|Median
2794956|NCT00556712|Secondary|PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||weeks||95% Confidence Interval|Median
2797241|NCT00542178|Secondary|Loss of Visual Acuity||Measured at Year 4|Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity.|||Participants|||Count of Participants
2794936|NCT00556712|Secondary|Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)|"Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,|||percentage of participants|||Number
2794937|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)|"TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS|||percentage of participants||95% Confidence Interval|Number
2794938|NCT00556712|Secondary|Time to Deterioration in TOI (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS|||weeks||95% Confidence Interval|Median
2794939|NCT00556712|Secondary|Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)|"The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.|||percentage of participants|||Number
2794940|NCT00556712|Primary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794941|NCT00556712|Primary|PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS;only participants with EGFR IHC positive tumors were included in the analysis.|||weeks||95% Confidence Interval|Median
2794942|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS|||percentage of participants||95% Confidence Interval|Number
2794957|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants|||Number
2794943|NCT00556712|Secondary|Time to Symptom Progression (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS|||weeks||95% Confidence Interval|Median
2794944|NCT00556712|Secondary|Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.|||percentage of participants|||Number
2794945|NCT00556712|Secondary|Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)|Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794946|NCT00556712|Secondary|Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794947|NCT00556712|Secondary|Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)|Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794958|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS|||percentage of participants||95% Confidence Interval|Number
2794959|NCT00556712|Secondary|OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||months||95% Confidence Interval|Median
2794948|NCT00556712|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.|||percentage of participants||95% Confidence Interval|Number
2794949|NCT00556712|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)|BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794950|NCT00556712|Secondary|Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)|TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2794951|NCT00556712|Secondary|Time to Progression (Data Cutoff 17 May 2008)|The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.|||weeks||95% Confidence Interval|Median
2794952|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794953|NCT00556712|Secondary|OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||months||95% Confidence Interval|Median
2794954|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants|||Number
2794955|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC negative tumors were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2794960|NCT00556712|Secondary|Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||percentage of participants|||Number
2794961|NCT00556712|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS|||percentage of participants||95% Confidence Interval|Number
2794962|NCT00556712|Secondary|Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS|||months||95% Confidence Interval|Median
2794963|NCT00556712|Secondary|Percentage of All Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).|FAS|||percentage of participants|||Number
2794964|NCT00556712|Primary|Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.|||percentage of participants|||Number
2794965|NCT00556712|Primary|Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2794966|NCT00556712|Primary|PFS in All Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.|||weeks||95% Confidence Interval|Median
2794967|NCT00556712|Primary|Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)|Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.|||percentage of participants|||Number
2794968|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||hours||Full Range|Median
2794969|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||hours||Full Range|Median
2794970|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg/mL||Standard Deviation|Mean
2794971|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg/mL||Standard Deviation|Mean
2794972|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg*h/mL||Standard Deviation|Mean
2794973|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.|||pg*h/mL||Standard Deviation|Mean
2797281|NCT00541866|Secondary|All Cause Mortality|Mortality of those patients enrolled in the study and receiving intervention|30 and 60 days|All treated analysis set|||Participants|||Count of Participants
2794975|NCT00556673|Secondary|Change From Period Baseline in Peak FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||ratio||90% Confidence Interval|Least Squares Mean
2794976|NCT00556673|Secondary|Change From Period Baseline in Trough FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population|||ratio||90% Confidence Interval|Least Squares Mean
2794977|NCT00556673|Secondary|Change From Period Baseline in Peak Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||liters||90% Confidence Interval|Least Squares Mean
2794978|NCT00556673|Secondary|Change From Period Baseline in Trough Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population|||liters||90% Confidence Interval|Least Squares Mean
2794979|NCT00556673|Secondary|Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||Percent of predicted||90% Confidence Interval|Least Squares Mean
2794980|NCT00556673|Secondary|Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population|||Percent of predicted||90% Confidence Interval|Least Squares Mean
2794981|NCT00556673|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population|||liters||90% Confidence Interval|Least Squares Mean
2794982|NCT00556673|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population included all patients randomized that received at least one dose of study drug and completed the first two treatment periods with evaluable data for the primary efficacy variable, and with no major protocol deviations. 7 patients who were inadvertently unblinded by the investigator were excluded from the PD analysis.|||liters||90% Confidence Interval|Least Squares Mean
2794983|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||PRI||Standard Deviation|Mean
2794984|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||PPI||Standard Deviation|Mean
2794985|NCT00556543|Primary|The Rand 36-Item Health Survey Results - General Health Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794986|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Bodily Pain Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794987|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Social Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794988|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Emotional Well-being Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794989|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Vitality Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794990|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794991|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794992|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Physical Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol|||RAND-36 scale units||Standard Deviation|Mean
2794993|NCT00556543|Primary|Adverse Post-op Events Related to the Repair and Plating System|Clinical evaluations or chest radiographs at a minimum of 1 and 6 months|180 days|Per Protocol|||Participants|||Number
2794994|NCT00556504|Secondary|Immune Cell Normalization|Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)||||participants|||Number
2794995|NCT00556504|Secondary|Immune Cell Normalization|"Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment~(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)"|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
2794996|NCT00556504|Secondary|Combined ALT and Virologic Response|Combined ALT and virologic response at the end of combination drug treatment.|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
2794997|NCT00556504|Secondary|Sustained ALT Response|a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)||||participants|||Number
2794998|NCT00556504|Secondary|ALT Response|"An ALT response is defined as normalization of ALT at the end of combination drug treatment.~(ALT normalization is defined as ALT level decreases into within the normal range)"|at the end of combination drug treatment (up to 48 weeks)||||participants|||Number
2797303|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population||Week 13|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2795000|NCT00556504|Primary|Sustained Virologic Response (SVR)|"SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..~A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.~If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.~If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)"|24 weeks after the termination of combinational drug treatment (up to 72 weeks)||||Number of participants with SVR|||Number
2795001|NCT00556491|Secondary|Re-operation||30 days post-operative||||Participants|||Count of Participants
2795002|NCT00556491|Secondary|Stroke Post Operative||30 days post op||||Participants|||Count of Participants
2795003|NCT00556491|Secondary|Infections Post Operative||30 days post operative||||Participants|||Count of Participants
2795004|NCT00556491|Secondary|On Vent >48 Hours|on ventilator > 48 hours|30 days post op||||percentage of participant per group|||Number
2795005|NCT00556491|Secondary|Post Operative Hospital Days||30 days post-operative||||days||Standard Error|Mean
2795006|NCT00556491|Primary|Development of Post-operative Acute Kidney Injury|Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively|up to 5 days post cardiac surgery||||participants meeting primary oputcome|||Number
2795007|NCT00556478|Secondary|Partner Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3.|3 months|ITT|||percentage of partners|||Number
2795008|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3.|3 months|ITT|||percentage of participants|||Number
2795009|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 2|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2.|2 months|ITT|||percentage of participants|||Number
2795010|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|2 months|ITT|||Score||Standard Deviation|Mean
2795011|NCT00556478|Secondary|Subject PEP at Month 1|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1.|1 month|ITT|||percentage of participants|||Number
2795012|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|1 month|ITT|||Score||Standard Deviation|Mean
2795013|NCT00556478|Secondary|Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3|Summary of mean IELT at Baseline and at month 3 during double-blind treatment|3 months|ITT|||Seconds||Standard Deviation|Geometric Mean
2795014|NCT00556478|Secondary|Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment|Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects|3 months|ITT|||percentage of subjects|||Number
2795015|NCT00556478|Primary|Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3|"To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by:~• changes in all 3 IPE domains from baseline to month 3~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|Baseline to 3 Months|ITT|||Score||Full Range|Mean
2795016|NCT00556478|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment|"To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:~• change in mean IELT from baseline to during the 3 month double-blind treatment~Results provide are ratio (over the 3 months/baseline)."|Baseline to 3 Months|ITT|||ratio||Full Range|Geometric Mean
2795017|NCT00556452|Secondary|Five Year Overall Survival for All Cases|The number of patients alive at 5 years|five years||||Participants|||Count of Participants
2795018|NCT00556452|Secondary|Two-year Overall Survival for All Cases.|Percent Overall Survival (OS) at two years for all patients.|2 years||||percent overall survival||95% Confidence Interval|Number
2795019|NCT00556452|Primary|One-year Overall Survival Rate for AML|Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).|1 year|Patients with Acute Myeloid Leukemia (AML)|||percent overall survival||95% Confidence Interval|Number
2795020|NCT00556452|Primary|Regimen Related Toxicities|The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).|two years||||toxicities|||Number
2795021|NCT00556439|Primary|Primary Outcome - Relapse-free Survival (RFS)|"Relapse: presence of active disease occurring after a period of remission~Remission: absence of active disease~Active disease defined by clinical features or imaging or both:~Clinical features:~1 or more of the following attributed to GCA/TAK:~Sustained fever of >38 C for > 1 week~Vascular pain/tenderness > 1 day, non-fleeting~Headache a) present > 1 day b) non-fleeting c) not relieved with analgesics d) not typical for pre-existing headaches~Ischemic retinopathy, optic neuropathy, or visual loss~Tongue/jaw pain and/or claudication~TIA or stroke~Extremity claudication~Musculoskeletal symptoms + ESR of > 40 mm/hr or CRP above the normal limit~Malaise/fatigue + ESR of > 40 mm/hr or CRP above the normal limit~Other symptoms/signs due to GCA/TAK requiring reinstitution/increase in GC~Imaging features~• Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram"|Weeks 0 to 64|The primary study endpoint was relapse-free survival (RFS). Kaplan-Meier curves of RFS were constructed for each stratum (giant cell arteritis and Takayasu arteritis), and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.|||Participants|||Count of Participants
2795022|NCT00556426|Secondary|Incidence of Filter Fracture|occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)|at 6 months or at retrieval of the filter|adequate imaging was available to assess filter integrity in 83 of the 100 participants.|||number of fractured filters|||Number
2795023|NCT00556426|Secondary|Filter Migration > 2cm|Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.|30 days post retrieval or 6 months following filter placement|Migration measurement made for 58 retrieved subjects, 22 non-retrieved subjects reaching the 6 month visit, and 2 non-retrieved subjects with attempted retrievals and imaging.|||Percent Subjects with Filter Migration|||Number
2795024|NCT00556426|Primary|Percentage of Participants With Adverse Events Through 30 Days Post Retrieval|Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure|30 days post retrieval|61 of 100 patients underwent filter retrieval during the study.|||percentage of participants||95% Confidence Interval|Number
2795025|NCT00556426|Primary|Clinical Success (Retrieval)|technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.|Time of Retrieval or through 6 months of implantation|61/100 patients experienced filter retrieval during the study|||participants|||Number
2795026|NCT00556426|Primary|Technical Success (Retrieval)|Technical success for retrieval of the filter such that the entire filter is removed.|1 month post filter retrieval or through 6 months following implantation|61 of 100 patients enrolled underwent filter retrieval during the study.|||participants|||Number
2795027|NCT00556400|Secondary|Total Number of Bleeding Days During the First 7 Days.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
2795028|NCT00556400|Secondary|Proportion Who Stop Uterine Bleeding by Day 14.||2 weeks|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
2795029|NCT00556400|Primary|Stop Vaginal Bleeding or Spotting.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
2795030|NCT00556374|Secondary|Overall Survival|Overall survival (OS) determined by the time from randomization to death from any cause. OS will be analyzed after long-term follow-up is complete.|Participants will be followed for overall survival once every 12 months for 66 months after primary completion date.||2021-06-30|06/2021||||
2795031|NCT00556374|Secondary|Bone Metastases-free Survival|Bone metastasis-free survival (BMFS) determined by the time from randomization to the first observation of bone metastasis or death from any cause. BMFS will be analyzed after long-term follow-up is complete.|Participants will be followed for bone metastasis-free survival once every 12 months for 66 months after primary completion date.||2021-06-30|06/2021||||
2795032|NCT00556374|Secondary|Disease-free Survival|"Disease-free survival (DFS) is defined as the time interval from the randomization date to the date of first evidence of local or distant metastases, contra-lateral breast cancer, secondary carcinoma, or death from any cause (whichever occurred first). Participants last known to be alive, who did not experience recurrence of disease, were censored at their last contact date or at the data cut-off date whichever came first.~DFS was initially specified to be analyzed after completion of the long-term follow-up period, however after analysis of the primary results was completed the data monitoring committee recommended that the analysis be conducted 18 months after the primary analysis data cut-off date."|From randomization until the DFS data cut-off date of 15 September 2015; maximum time on study was 102 months.|Full analysis set|||days||95% Confidence Interval|Median
2795033|NCT00556374|Secondary|Number of Participants With New or Worsening Vertebral Fractures|Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures is defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.|||participants|||Number
2795060|NCT00556322|Primary|Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)|Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months|FAS population|||percentage of participants|||Number
2795061|NCT00556166|Secondary|Number of Episodes of Abdominal Pain, Bloating, and Early Satiety|Data was not analyzed because PI left institution and terminated the study early.|1 year|||||||
2795034|NCT00556374|Secondary|Number of Participants With New Vertebral Fractures|"Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height.~A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays."|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.|||participants|||Number
2795035|NCT00556374|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - femoral neck at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for femoral neck)|||percent change||95% Confidence Interval|Least Squares Mean
2795036|NCT00556374|Secondary|Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total hip at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total hip)|||percent change||95% Confidence Interval|Least Squares Mean
2795037|NCT00556374|Secondary|Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total lumbar spine at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total lumbar spine)|||percent change||95% Confidence Interval|Least Squares Mean
2795038|NCT00556374|Primary|Time to First Clinical Fracture|The time to first on-study clinical fracture defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.|From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on study was 87 months.|Full analysis set (all randomized participants)|||days||95% Confidence Interval|Median
2795039|NCT00556322|Secondary|Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2795040|NCT00556322|Secondary|Time to Deterioration in the TOI|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||weeks||95% Confidence Interval|Median
2795041|NCT00556322|Secondary|Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)|TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants|||Number
2795042|NCT00556322|Secondary|Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L|Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2795057|NCT00556322|Secondary|Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative|||percentage of participants|||Number
2795043|NCT00556322|Secondary|Time to Symptomatic Progression Using FACT-L|Participants' responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||weeks||95% Confidence Interval|Median
2795044|NCT00556322|Secondary|Percentage of Participants With Symptomatic Progression Using FACT-L|Participants' responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants|||Number
2795045|NCT00556322|Secondary|Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2795046|NCT00556322|Secondary|Time to Deterioration in Quality of Life Using FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||weeks||95% Confidence Interval|Median
2795047|NCT00556322|Secondary|Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.|||percentage of participants|||Number
2795048|NCT00556322|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST|Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2795058|NCT00556322|Primary|Probable Percentage of Participants Remaining Alive at 1 Year|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population|||percentage of participants||95% Confidence Interval|Number
2795059|NCT00556322|Primary|Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population|||months||95% Confidence Interval|Median
2795049|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. Tumor response was evaluated according to RECIST criteria (version 1.0). PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population; n=number of EGFR positive or negative participants who remained at risk|||percentage of participants||95% Confidence Interval|Number
2795050|NCT00556322|Secondary|PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only Participants with confirmed status of EGFR were included in the analysis; number of participants who were EGFR positive or negative|||weeks||95% Confidence Interval|Median
2795051|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative|||percentage of participants|||Number
2795052|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population|||percentage of participants||95% Confidence Interval|Number
2795053|NCT00556322|Secondary|Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population|||weeks||95% Confidence Interval|Median
2795054|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.0). Progressive Disease was defined as at least a 20 percent (%) increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The primary analysis of PFS used objective progression (RECIST) plus clinical progression (based on relevant clinical findings - if any). A further assessment of PFS was made on objective (radiological) progression. If clinical progression was diagnosed first, the participant was censored at the date of the last tumor assessment, where non-progression was documented.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population|||percentage of participants|||Number
2795055|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population; n=number of EGFR positive or negative participants remaining at risk|||percentage of participants||95% Confidence Interval|Number
2795056|NCT00556322|Secondary|Duration of OS in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative|||months||95% Confidence Interval|Median
2795062|NCT00556166|Primary|Number of Episodes of Nausea and Vomiting|Data was not analyzed because PI left institution and terminated the study early.|1 year|||||||
2795063|NCT00556140|Secondary|Depression and Psychosis Remission Rate|This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."|||percent of participants|||Number
2795064|NCT00556140|Primary|Depression and Psychosis Response Rate|This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."|||percent of participants|||Number
2795065|NCT00556075|Secondary|The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits||days|Zero participants were analyzed because no data were collected due to early termination||||||
2795066|NCT00556075|Secondary|Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination||||||
2795067|NCT00556075|Secondary|Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination||||||
2795068|NCT00556075|Secondary|Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits||monthly|Zero participants were analyzed because no data were collected due to early termination||||||
2795069|NCT00556075|Primary|Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination||||||
2795070|NCT00556075|Primary|Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination||||||
2795071|NCT00556049|Primary|To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.||Until disease progression||||percentage of participants|||Number
2795072|NCT00555997|Secondary|Change in 6-VAS-D Scores During Each Phase.||6 weeks|Forms not analyzable due to insufficient standardization across sites.||||||
2795073|NCT00555997|Secondary|Responder/Non-responder|A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).|6 weeks||||percentage of patients|||Number
2795074|NCT00555997|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.|6 weeks||||points||Standard Deviation|Mean
2795075|NCT00555971|Secondary|Measurements of Urinary LTE4 in Association With Respiratory Reaction During Aspirin Desensitization|Measurements of urinary LTE4 in association with aspirin desensitization, comparing subjects randomized to placebo with subjects randomized to omalizumab, with study drug administered for 16 weeks. Measurements were compared for respiratory reaction in placebo subjects who exhibited either upper or lower airway reaction and after 100 mg aspirin challenge dose in omalizumab subjects who were non-reactors.|Approximately 24 weeks||||pg/mg creatinine units||Standard Error|Mean
2795076|NCT00555971|Primary|Number of Participants Without Respiratory Reaction During Aspirin Desensitization|Lack of Respiratory reaction during aspirin desensitization, including Spirometry (FEV1) testing, to assess the efficacy of Xolair on attenuating aspirin induced bronchospasm in patients with AERD.|24 weeks||||Participants|||Count of Participants
2795077|NCT00555906|Secondary|Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2|"m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 No pain to 10 Pain as bad as you can imagine. The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference."|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||95% Confidence Interval|Mean
2795091|NCT00555906|Primary|Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1|MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc >500 millisecond [msec]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count <25,000/mcL and/or ANC <500/mcL, or due to prolonged nonhematologic toxicities of Grade >=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.|||milligram (mg)|||Number
2795078|NCT00555906|Secondary|Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2|The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.|||units on a scale||95% Confidence Interval|Mean
2795079|NCT00555906|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Patient Reported Outcomes (PRO) analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||95% Confidence Interval|Mean
2795080|NCT00555906|Secondary|Number of Participants With Laboratory Abnormalities: Phase 2|Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology [C reactive protein]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
2795081|NCT00555906|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
2795082|NCT00555906|Secondary|Number of Participants With Adverse Events (AEs) by Severity: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
2795083|NCT00555906|Secondary|Overall Survival (OS): Phase 2|OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date [if death date unavailable] minus the date of first dose of study medication plus 1) divided by 30.44.|Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||months||95% Confidence Interval|Median
2795092|NCT00555893|Secondary|Mean Influenza Well-being Score|Mean influenza wellbeing score is calculated by first summing the daily scores for overall health (0-9 points), ability to perform usual activities (0-9 points), and sleep quality (0-9 points) from initial enrollment (randomization) up to (and including) the first day of symptom resolution. This is divided by the number of reporting days to yield the mean daily influenza wellbeing score for each person. Minimum score is 0 and maximum is 27. Higher scores indicate better outcome.|Randomization to resolution|The analysis is restricted to subjects randomized 48 to 119 hours after illness onset.|||score on a scale||Standard Deviation|Mean
2795093|NCT00555893|Secondary|Secondary Complications (Otitis Media, Sinusitis, Pneumonia, Hospital Admission)||30 days from symptom onset|These data were not collected because study was terminated early and did not achieve target enrollment.||||||
2795084|NCT00555906|Secondary|Duration of Objective Response (DR): Phase 2|DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24hr urine M-protein. PR:>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr. PD: >=25% increase from lowest response level in serum M-component, urine M-component, >=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.|||months||95% Confidence Interval|Median
2795085|NCT00555906|Secondary|Progression-free Survival (PFS): Phase 2|"PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder."|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||months||95% Confidence Interval|Median
2795086|NCT00555906|Secondary|Time to Tumor Progression (TTP): Phase 2|TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per IMWGURC). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||months||95% Confidence Interval|Median
2795087|NCT00555906|Secondary|Best Overall Response: Phase 1|Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24 hr urine M-protein. PR: >=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200mg/24 hr. Progressive disease (PD): >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met.|Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.|||participants|||Number
2795088|NCT00555906|Secondary|Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1||Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Results are not reported because data was present as individual participant listings but not summarized for analysis, as per change in planned analysis.||||||
2795089|NCT00555906|Primary|Percentage of Participants With Objective Response (OR): Phase 2|OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein, <100 mg/24 hour (hr) urine M-protein. PR: >=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr, >=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, >= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was >=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable.|Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B)|Primary response analysis set (PRAS) included first consecutive (by first treatment day) participants in response analysis set (RAS=included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable.|||percentage of participants||95% Confidence Interval|Number
2795090|NCT00555906|Primary|Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1|RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.|||milligram (mg)|||Number
2798910|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2795094|NCT00555893|Secondary|Viral Shedding on Day 3-4 of Treatment|Proportion of participants with positive PCR on day 3-4 of treatment|3-4 days after treatment initiation|134 subjects were randomized and initiated treatment 48-119 hours after illness onset (late treatment group). Of these 95 received oseltamivir and 39 received placebo.|||Participants|||Count of Participants
2795095|NCT00555893|Secondary|Mean Illness Severity Score|Mean severity score will be calculated by first summing the symptom severity scores for all reporting periods from initial enrollment (randomization) up to (and including) the first period of symptom resolution, as defined above. The summed total will be divided by the number of reporting periods to yield the mean severity score for each participant. For each reporting period, the possible symptom scores will range from 0 (all symptoms absent) to 24 (all symptoms severe). For children less than 2 years old, the possible scores will range from 0 to 15.|Calculated from initial enrollment (randomization) up to first period of symptom resolution (minimum of 7 days, maximum of 14 days)|All participants over 24 months of age (n=5 were excluded because <24 months)|||mean severity score||Inter-Quartile Range|Median
2795096|NCT00555893|Primary|Duration of Influenza Illness|Resolution is defined as occurring at the start of the first 24-hour period in which the total symptom score was less than or equal to 2 with no symptom rated higher than mild. Time to resolution was calculated from the time of randomization to symptom resolution in 12 hour increments.|Interval (in 12 hour blocks) from time of randomization until resolution (minimum 7 days, maximum 14 days)||||days||95% Confidence Interval|Median
2795097|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Urinalysis at Discharge|For urinalysis, samples were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination): glucose, blood, protein, pH, specific gravity, leukocyte esterase, and microscopic examination. A shift in reference to normal was higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.|||participants|||Number
2795098|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing-Re-analysis With The Koch Procedure|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. The Koch procedure is a 3-step process to analyze results while utilizing the available information on magnitude of differences.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Deviation|Mean
2795099|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Clinical Chemistry at Discharge|For biochemistry, blood samples (10.0mL) were taken at screening, admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: sodium, potassium, calcium, blood urea nitrogen (BUN)/Urea, creatinine, albumin, total protein and albumin/globulin (A/G) ratio, globulin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total bilirubin, glucose, chloride, and creatine kinase. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.|||participants|||Number
2795100|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Hematology Analytes at Discharge|For hematology, blood samples (5.0mL) were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: hemoglobin, hematocrit, red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count - total and differential (WBC), and platelet count. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.|||participants|||Number
2795101|NCT00555880|Secondary|Heart Rate at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Heart rate was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||beats per minute||Standard Deviation|Mean
2795114|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set (FAS), defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Deviation|Mean
2795102|NCT00555880|Secondary|Diastolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||mmHg||Standard Deviation|Mean
2795103|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 1 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The FAS, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Error|Least Squares Mean
2795104|NCT00555880|Secondary|Systolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||mmHg||Standard Deviation|Mean
2795105|NCT00555880|Secondary|Final Blood Pressure During Tilt Table Testing|Blood pressure was recorded just before tilt table testing and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||mmHg||Standard Deviation|Mean
2795106|NCT00555880|Secondary|Number of Participants With Improvement of Patient CGI-I Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject's orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The patient completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||participants|||Number
2795107|NCT00555880|Secondary|Number of Participants With Improvement of Clinician Clinician's Global Impression- Improvement (CGI-I) Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject's orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The clinician completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||participants|||Number
2795108|NCT00555880|Secondary|Scores for 6 Items of The OHSA|"The OHSA measures the severity of six symptoms/symptom complexes associated with OH: dizziness, lightheadedness, and feeling faint; problems with vision; weakness; fatigue; trouble concentrating; and head/neck discomfort. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from none to worst possible. Scores for each subscale range from 0 (no symptoms) to 10 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, and feeling faint."|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||scores on a scale||Standard Deviation|Mean
2795109|NCT00555880|Secondary|Total Score of the Orthostatic Hypotension Symptom Assessment (OHSA)|"The OHSA measures the severity of six symptoms/symptom complexes associated with orthostatic hypotension. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from none to worst possible. The OHSA total score is the sum of six subscales, ranging from 0 (no symptoms) to 60 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||scores on a scale||Standard Error|Least Squares Mean
2795110|NCT00555880|Secondary|Duration of The Effect of Treatment at 3 Hours Post-dose|Duration of effect was defined as the difference in time to onset of near-syncopal symptoms between the first and second tilt table test, conducted at 1 hour and 3 hours post-dose, respectively, at Treatment Visit 2 (time to onset at 3 hours minus time at 1 hour). The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Deviation|Mean
2795111|NCT00555880|Secondary|Time to Near-syncopal Symptoms at Treatment Visit 1|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.|||seconds||Standard Error|Least Squares Mean
2795112|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 4 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.|||seconds||Standard Error|Least Squares Mean
2795113|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.|||seconds||Standard Deviation|Mean
2798911|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2795116|NCT00555750|Secondary|Change in Total Sleep Time as Reported in Sleep Diaries|Total sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).|baseline and 2 months post-treatment||||hours||Standard Deviation|Mean
2795117|NCT00555750|Secondary|Change in Mean Lapses of Attention|At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.|baseline and 2 months post-treatment||||lapses of attention||Standard Error|Mean
2795118|NCT00555750|Secondary|Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)|"At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 (very alert) to 9 (very sleepy, fighting sleep, an effort to keep awake). Subjective sleepiness was defined as mean deviation from baseline KSS."|baseline and 2 months post-treatment||||units on a scale||Standard Error|Mean
2795119|NCT00555750|Secondary|Post-treatment Ghrelin Levels|Ghrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|2 months post-treatment||||ng/mL||Standard Deviation|Mean
2795120|NCT00555750|Secondary|Pre-treatment Ghrelin Levels|Ghrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|baseline||||ng/mL||Standard Deviation|Mean
2795121|NCT00555750|Secondary|Post-treatment Leptin Levels|Leptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|two months post-treatment||||ng/mL||Standard Deviation|Mean
2795122|NCT00555750|Secondary|Pre-Treatment Leptin Levels|Leptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast|baseline||||ng/mL||Standard Deviation|Mean
2795123|NCT00555750|Secondary|Change in HbA1c Levels|Difference in HbA1c levels following two months treatment with eszopiclone versus placebo|baseline and 2 months post-treatment||||percentage of glycosylation||Standard Error|Mean
2795124|NCT00555750|Secondary|Change in Glucose Effectiveness (SG)|"Glucose effectiveness was defined as the ability of glucose itself to enhance its own disappearance independent of an increment in insulin. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].~SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment||||min^-1||Standard Deviation|Mean
2795125|NCT00555750|Secondary|Change in Insulin Sensitivity (SI)|"Insulin sensitivity index (SI) was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].~SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment||||mU/l)^-1*min^-1||Standard Deviation|Mean
2795126|NCT00555750|Secondary|Acute Insulin Response to Glucose (AIRg)|Change over two months in 1st phase Insulin secretion|baseline and 2 months post-treatment||||mU*l^-1*min||Standard Deviation|Mean
2795127|NCT00555750|Primary|Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test|Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.|baseline and 2 months post-treatment||||%/min, slope of natural log glucose||Standard Deviation|Mean
2795128|NCT00555672|Secondary|Progression-Free Survival (PFS)|Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.|Baseline up to Month 15|Efficacy|||Months||95% Confidence Interval|Median
2795129|NCT00555672|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.|Baseline up to Month 15|Efficacy; N=number of participants with objective response.|||Months||Standard Deviation|Mean
2795130|NCT00555672|Secondary|Number of Participants With Objective Response|Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 Months|Efficacy: all participants enrolled in the study who received at least 1 dose of study medication. N=number of participants with measurable disease at baseline.|||Participants|||Number
2795131|NCT00555672|Secondary|Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU|Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||ng*h/mL||Standard Deviation|Mean
2795132|NCT00555672|Secondary|Clearance (CLss) of 5-FU|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=the number of participants contributing to the summary statistics. CLss calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||Liters per hour||Standard Deviation|Mean
2797304|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2795133|NCT00555672|Secondary|Infusion Rate (Zero Order) (R0) of 5-FU|Infusion rate of 5-FU equals total dose divided by infusion time.|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N= number of participants contributing to the summary statistics. R0 calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||mg/hr||Standard Deviation|Mean
2795134|NCT00555672|Secondary|Steady State Concentration (Css) of 5-Fluorouracil (5-FU)|Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||ng/mL||Standard Deviation|Mean
2795135|NCT00555672|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|PK; N=the number of participants contributing to the summary statistics. Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).|||hours||Full Range|Median
2795136|NCT00555672|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)|PK; N=the number of participants contributing to the summary statistics. AUC(0-24) of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the maximum tolerated dose (MTD; 25 mg Sunitinib).|||ng*h/mL||Standard Deviation|Mean
2795137|NCT00555672|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|Pharmacokinetic (PK): participants who received Sunitinib and had sufficient plasma concentration data for calculation of PK parameters; N=number of participants contributing to summary statistics. Cmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at maximum tolerated dose.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2795138|NCT00555672|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|The incidence of DLTs assessed during the first cycle (21 days).|Cycle 1 (Baseline to Day 21)|Safety: enrolled participants who received at least 1 dose of study drug.|||Participants|||Number
2795139|NCT00555620|Secondary|Progression-Free Survival (PFS)|PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis subset of population of participants who had an event|||months||95% Confidence Interval|Median
2795140|NCT00555620|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 reporting group analyzed; all had stable disease during specified time frame|||months||Full Range|Median
2795141|NCT00555620|Secondary|Percentage of Participants With Objective Response|Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 months|Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).|||percentage of participants||95% Confidence Interval|Number
2795142|NCT00555620|Secondary|AUClast for 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
2795143|NCT00555620|Secondary|AUClast for 5'DFUR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
2795144|NCT00555620|Secondary|AUClast for 5'DFCR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
2795145|NCT00555620|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
2795146|NCT00555620|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)|Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
2795166|NCT00555620|Secondary|Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795147|NCT00555620|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category|||ng*hr/mL||Standard Deviation|Mean
2795148|NCT00555620|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2795149|NCT00555620|Secondary|t1/2 for 5-FU|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
2795150|NCT00555620|Secondary|t1/2 for 5'DFUR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
2795151|NCT00555620|Secondary|t1/2 for 5'DFCR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
2795152|NCT00555620|Secondary|t1/2 for CAP|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data|||hr||Standard Deviation|Mean
2795153|NCT00555620|Secondary|Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.||||||
2795154|NCT00555620|Secondary|Tmax for 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
2795155|NCT00555620|Secondary|Tmax for 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
2795156|NCT00555620|Secondary|Tmax for 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
2795157|NCT00555620|Secondary|Tmax for CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hr||Full Range|Median
2795158|NCT00555620|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||hour (hr)||Full Range|Median
2795159|NCT00555620|Secondary|Cmin of 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795160|NCT00555620|Secondary|Cmin of 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795161|NCT00555620|Secondary|Cmin of 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795162|NCT00555620|Secondary|Cmin of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795163|NCT00555620|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795164|NCT00555620|Secondary|Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795165|NCT00555620|Secondary|Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795167|NCT00555620|Secondary|Cmax of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data|||ng/mL||Standard Deviation|Mean
2795168|NCT00555620|Secondary|Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2795169|NCT00555620|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21|DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.|||participants|||Number
2795170|NCT00555581|Secondary|Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire: Physical Component Summary|The Short Form 36 (SF-36) is a 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. The physical component score is composed of a subset of the 8 health domains.The SF-36 physical component can be obtained by looking at the mean average of all the physically relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. Change in Short Form 36 physical component (SF-36 PC) is measured by Mean change (and 95 % Confidence Interval) from Baseline mean to Month 12 mean (the average change in SF-36 physical component from baseline to month 12).|12 months||||units on a scale||95% Confidence Interval|Mean
2795171|NCT00555581|Secondary|Scleroderma Health Assessment Questionnaire Disability Index|"The Scleroderma Health Assessment Questionnaire (SHAQ) consist of the Health Assessment Questionnaire (HAQ) and 8 other domains which include scales looking at pain, patient global assessment, vascular, digital ulcers, lung involvement, and gastrointestinal involvement. It addresses scleroderma related manifestations that contribute to disability. It is a quality of life measure. Each question is scored from 0 (without difficulty) to 3 (unable to do). Some domains in the SHAQ are visual analog scales that are measured first and then changed to a 0-3 scale.~The maximum from each category is added together and divided by the number of categories completed. Change in Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) is measured as Mean Change (and 95% Confidence Interval) from Baseline mean to Month 12 mean (the average change in SHAQ-DI from baseline to month 12)."|12 months||||units on a scale||95% Confidence Interval|Mean
2795172|NCT00555581|Secondary|Change From Baseline at Month 12 in Short Form-36 (SF-36) Questionnaire:Mental Component Summary|The Short Form 36 (SF-36) is a validated 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. The mental component score is composed of a subset of the 8 health domains. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.The SF-36 mental component can be obtained by looking at the mean average of all the emotionally relevant items. Change in Short Form 36 mental (SF-36 MC) is measured by Mean change (and 95 % Confidence Interval) from Baseline mean to Month 12 mean (the average change in SF-36 mental component from baseline to month 12).|12 months||||units on a scale||95% Confidence Interval|Mean
2795173|NCT00555581|Secondary|Improvement in Indices of Pulmonary Function Measured by Change DLCO hb Adj % Predicted|This outcome measure includes patients with and without the presence of Interstitial Lung Disease (ILD). Diffusion capacity of the lungs for carbon monoxide (DLCO) measures how much oxygen travels from the alveoli of the lungs to the blood stream. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer. DLCO results are compared to normal values for a patient's height, age, sex, and ethnicity. A DLCO result that is at least 80% of the predicted value is considered normal. Improvement in DLCO hb adj % predicted is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean (the average change in DLCO hb adj% from baseline to month 12).|12 months||||DLCO%||95% Confidence Interval|Mean
2795174|NCT00555581|Secondary|Improvement in Indices of Pulmonary Function Measured by Change in FVC % Predicted|This outcome measure includes patients with and without the presence of Interstitial Lung Disease (ILD). Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking a deep breath. It is used to determine the severity of lung disease. Improvement in FVC % predicted is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean. Results are compared to the predicted values that are calculated from a patients age, size, weight, and sex. Results are considered normal if FVC is 80 percent or more of the predicted value. Mean change in FVC % predicted is measured by the average change in FVC% percent predicted from baseline to month 12.|12 months||||FVC%||95% Confidence Interval|Mean
2795207|NCT00555321|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase|A participant who did not have diabetes prior to randomization was determined to have NODM if(i) the participant received an antidiabetic medication for a duration of at least 30 days or(ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is>=126 mg/dL (7.0 mmol/L). For 95% CI within each group, normal approximation is used if N>=5. For 95% CI of difference, adjustment is made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm.|6 and 12 months posttransplant|ITT population, all randomized participants without Diabetes Mellitus (pre-transplantation).|||percentage of participants||95% Confidence Interval|Number
2795175|NCT00555581|Primary|Improvement in the Modified Rodnan Skin Score|Improvement in the Modified Rodnan Skin Score (MRSS) is measured by Mean change (and 95% Confidence Interval) from Baseline mean to Month 12 mean.Measure Description: The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is 0 for uninvolved skin through 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease. The mean change in MRSS represents the average change in total skin score from baseline to month 12.|12 months||||units on a scale||95% Confidence Interval|Mean
2795176|NCT00555568|Primary|Overall Mental Health (BASIS-24 Summary Score)|BASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.|3 months||||units on a scale||Standard Deviation|Mean
2795177|NCT00555568|Primary|VR-12 MCS|VR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;|3 months||||units on a scale||Standard Deviation|Mean
2795178|NCT00555568|Primary|Social Support|Social Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support|3 months||||units on a scale||Standard Deviation|Mean
2795179|NCT00555568|Primary|Empowerment|"Empowerment is measured by the Making Decisions instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment."|3 months||||units on a scale||Standard Deviation|Mean
2795180|NCT00555568|Primary|Patient Activation|"Patient activation refers to patient knowledge skill and confidence for self-management.~Full name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used."|3 months||||units on a scale||Standard Deviation|Mean
2795181|NCT00555477|Primary|The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy|In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.|12 months||||participants|||Number
2795182|NCT00555464|Secondary|Toxicity to Medications|"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details."|Initial visit, 2, 4, 6, 10 and 12 weeks of therapy||||participants|||Number
2795183|NCT00555464|Primary|Response of Hemangioma (IH) to Treatment|"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume."|6 weeks|Per protocol, all participants were analyzed, no matter the treatment arm or treatment success.|||participants|||Number
2795184|NCT00555438|Secondary|Death at 1 Month ± 5 Days|Evaluate the total number of death at 1 month ± 5 days|1 month ± 5 days||||participants|||Number
2795185|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days.|at 1 month ± 5||||participants|||Number
2795186|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10.|10 days||||participants|||Number
2795187|NCT00555438|Secondary|Number of Patients With Major Bleedings at 1 Month ± 5 Days.|evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days.|45 day||||participants|||Number
2795188|NCT00555438|Primary|Number of Patients With Major Bleedings Between Day 1 and Day 10.|evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L.|10 day||||participants|||Number
2795189|NCT00555425|Secondary|Health Status|Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|18 weeks|Results are provided on those individuals who completed this assessment|||units on a scale||Standard Deviation|Mean
2795190|NCT00555425|Secondary|Patient Satisfaction|Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.|18 weeks|Results are provided on those individuals who completed this assessment|||units on a scale||95% Confidence Interval|Mean
2795191|NCT00555425|Secondary|Changes in HIV Risk|"As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).~There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.~Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status."|Baseline and 18 weeks||||units on a scale||Standard Deviation|Mean
2795192|NCT00555425|Secondary|Reduction in Cocaine Use|As measured by the percent of provided urines positive for cocaine|18 weeks||||percent of cocaine positive urines||Standard Deviation|Mean
2795193|NCT00555425|Secondary|Retention in Treatment|Mean number of days from randomization to last clinical contact|18 weeks||||number of days||95% Confidence Interval|Mean
2795194|NCT00555425|Secondary|Proportion of Patients Protectively Transferred|>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study|18 weeks||||participants|||Number
2795195|NCT00555425|Primary|Illicit Opioid Use|Urinalysis based on scheduled weekly urine screenings during treatment period|18 weeks||||percent of opioid negative urine samples||95% Confidence Interval|Mean
2795196|NCT00555360|Secondary|Adherent to Heart Failure Medication|Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.|twelve-month follow-up||||percentage of participants/perfect adher|||Number
2795197|NCT00555360|Secondary|Revised Heart Failure Self-Care Behavior Scale (HFSCB)|Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.|twelve-month follow-up||||units on a scale||Standard Deviation|Mean
2795198|NCT00555360|Primary|Heart Failure-specific Quality of Life|Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.|twelve-month followup||||units on a scale||Standard Deviation|Mean
2795199|NCT00555321|Secondary|Change in Protein to Creatinine Ratio From Month 3 to Month 12.||Month 3 and 12|Protein creatinine ratio change was not analyzed||||||
2795200|NCT00555321|Secondary|Number of Participants Who Had Abnormalities in Electrocardiograms: 12-month Treatment Phase||Baseline (pretransplant), Week 52|ECG data was not analyzed.||||||
2795201|NCT00555321|Secondary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase|Low total calcium: <7 mg/dL; High total calcium: >12.5 mg/dL ; Low bicarbonate: <11 mEq/L; Low serum potassium: <3.0 mEq/L; High serum potassium:>6.0 mEq/L; High serum magnesium: >2.46 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; Low albumin: <2 g/dL; High uric acid: >10 mg/dL|Baseline (pretransplant), Weeks 4, 12, 24, and 52|ITT population, all randomized and transplanted participants. n= participants with all observations.|||participants|||Number
2795202|NCT00555321|Secondary|Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase|ULN= upper limit of normal; Normal ranges are provided by the central laboratory and may vary according to sex and age. High alkaline phosphatase (ALP): >5.0*ULN U/L; High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0 * ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Baseline (pretransplant), 4, 12, 24, 52 weeks|ITT population, all randomized and transplanted participants. n= participants with all observations.|||participants|||Number
2795203|NCT00555321|Secondary|Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase|Low hemoglobin: <8 g/dL; Low platelet count: <50*10^9 C/L; Low leukocytes: <2.0 *10^3 c/µL; Low lymphocytes (absolute): <0.5*10^3 c/µL; Low neutrophils (absolute): <1.0*10^3 Cc/µL.|Baseline (pretransplant), 2, 4, 8, 12 weeks, and every 4 weeks for week 16 to 52|ITT population, all randomized and transplanted participants. n= participants with all observations.|||participants|||Number
2795204|NCT00555321|Secondary|Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase|AE of of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial), serious infections|Day 1 (randomization) to 12 months or ≤ 56 days after discontinuation of study medication|ITT population, all randomized and transplanted participants.|||participants|||Number
2795205|NCT00555321|Secondary|Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Day 1 (randomization) to 12 m + 8 week follow-up or ≤ 56 days after discontinuation of study medication|ITT population: all randomized and transplanted participants|||participants|||Number
2795206|NCT00555321|Secondary|Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase|The HbA1c test is important in diabetes as a long-term measure of control over blood glucose, where the glucose bound to hemoglobin during the past 3-4 months is measured. A baseline diabetes participant was one who had a medical history of diabetes or being under anti-diabetic medication at the time of the transplantation. BL = baseline, DM = Diabetes mellitus.|6, 12 months (mth) posttransplant|ITT population, all randomized and transplanted participants. n = Participants with both baseline and postbaseline values.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
2795208|NCT00555321|Secondary|Number of Participants Who Received Anti-hypertensive Therapy at Month 12||12 months posttransplant|ITT population, all randomized and transplanted participants.|||participants|||Number
2795209|NCT00555321|Primary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE|Low Serum Potassium: <3.0 meq/L; High serum potassium:>6.0 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; High uric acid: >10 mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.|||participants|||Number
2795210|NCT00555321|Primary|Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE|ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0*ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.|||participants|||Number
2795211|NCT00555321|Primary|Number of Participants With Marked Hematology Abnormalities During the LTE|Low platelet count: <50*10^9 c/µl; Low leukocytes: <2.0*10^3 c/µl; Low lymphocytes (absolute): <0.5*10^3 c/µl; Low neutrophils (absolute): <1.0*10^3 c/µl.|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.|||participants|||Number
2795212|NCT00555321|Primary|Number of Participants Who Had AEs of Special Interest During the LTE|AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial).|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension|||participants|||Number
2795213|NCT00555321|Primary|Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)|ITT-LTE population, (all randomized and transplanted participants who entered long term extension). Participants were grouped according to the treatment to which they were randomized initially.|||participants|||Number
2795214|NCT00555321|Secondary|Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase|Percentage of participants at any given time who meet the definition of hypertension. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
2795215|NCT00555321|Secondary|Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase|Percentage of participants who develop hypertension after randomization and transplantation. Transient post-operative increases in BP were not to be counted as new onset hypertension. Hypertension was to be assessed only at or after the Week 4 visit. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
2795216|NCT00555321|Secondary|Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase||BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mm Hg||Standard Deviation|Mean
2795217|NCT00555321|Secondary|Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase|Participants were considered to have hypertension if they had Diastolic Blood Pressure (SBP) ≥ 80 mmHg.|BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mm Hg||Standard Deviation|Mean
2795218|NCT00555321|Secondary|Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase||Baseline (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mm Hg||Standard Deviation|Mean
2795219|NCT00555321|Secondary|Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
2795220|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants.|||mg/dL||Standard Deviation|Mean
2795221|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
2795222|NCT00555321|Secondary|Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
2795223|NCT00555321|Secondary|Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
2795224|NCT00555321|Secondary|Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase|Percentage of participants at any given time (at Month 6 and Month 12) who met the definition of dyslipidemia.Dyslipidemia is defined as hypertriglyceridemia (TGs ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (LDL ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
2795225|NCT00555321|Secondary|Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase|Percentage of participants who develop dyslipidemia, defined as hypertriglyceridemia (triglycerides [TGs] ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (Low density lipoprotein [LDL] ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-high density lipoprotein (non- high density lipoprotein [HDL] ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants who did not have dyslipidemia at baseline|||percentage of participants||95% Confidence Interval|Number
2795226|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 x 10^6 U/mL and > 4.7 x 10^6 U/mL were descriptively summarized by treatment group. BL = baseline|BL (pretransplant), 12, 18, 24, 30 months (mo) posttransplant|ITT-LTE population, all randomized and transplanted participants. n= participants with HCV RNA values.|||participants|||Number
2795227|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 * 10^6 U/mL and > 4.7 * 10^6 U/mL were descriptively summarized by treatment group. BL=baseline|Baseline (pretransplant), 6 and 12 months (mo) posttransplant|ITT population, all randomized and transplanted participants. n= participants who were HCV positive at baseline.|||participants|||Number
2795228|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|12 months posttransplant, end of study (database lock, 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension.|||percentage of participants||95% Confidence Interval|Number
2795229|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
2795230|NCT00555321|Secondary|Belatacept Trough Concentration Before Each Infusion During the LTE|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected predose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105, 532, 728.|All randomized participants who received Belatacept, and had complete PK profile. n= participants with values at all time points.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2795231|NCT00555321|Secondary|Belatacept PK Parameter: Clearance From Ascites Fluid|Clearance from ascites fluid was determined by amount excreted in ascites fluid (Ae, asc)[0-T] / AUC[0-T], where 0-T is the same duration relative to a belatacept infusion.|Days 1 to 14|Serum AUC was not available for the time interval corresponding to ascites fluid collection.||||||
2795232|NCT00555321|Secondary|Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14|Amount Excreted in Ascites (Ae,asc) was estimated from the ascites drug concentrations and volumes within a dosing interval.|Days 1 to 14|All randomized participants who received belatacept, and had complete PK profile.|||µg||Standard Deviation|Mean
2795233|NCT00555321|Secondary|Belatacept PK Parameter: Volume of Distribution|Volume of distribution (Vss) is the volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration. . Vss was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||L/kg||Standard Deviation|Mean
2795234|NCT00555321|Secondary|Belatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. CLT was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2795564|NCT00552669|Secondary|Major Adverse Cardiovascular Events (MACCE)|Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.|18 Months|It was determinated by ITT and the technique used was LOCF.|||participants|||Number
2795235|NCT00555321|Secondary|Belatacept PK Parameter: Terminal Half-life|Terminal Half-life (T 1/2) is the time a drug takes for the concentration levels to fall to 50% of their value.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||hour||Standard Deviation|Mean
2795236|NCT00555321|Secondary|Belatacept PK Parameter: Minimum Plasma Concentration|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2795237|NCT00555321|Secondary|Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau)|Area under the plasma concentration-time curve for each dosing interval is determined using the linear trapezoidal rule. The AUC(TAU) of belatacept from the MI regimens and LI regimens were calculated over 2 and 4 weeks respectively.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2795238|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration|Maximum Plasma Concentration (Tmax) is the time taken to reach the maximum observed plasma concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||hour||Full Range|Median
2795239|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration|Maximum Plasma Concentration (Cmax) is the maximum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2795240|NCT00555321|Secondary|Mean Change in Baseline Values of Cystatin C at 2 and 12 Months|Cystatin C is a protein encoded by the CST3 gene, which is mainly used as a biomarker of kidney function. If kidney function and glomerular filtration rate decline, the blood levels of cystatin C rise.|Baseline (pretransplant), 2, and 12 months posttransplant|ITT population: all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mg/L||Standard Deviation|Mean
2795241|NCT00555321|Secondary|Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12|Measurement of SCr is commonly used as an indicator of renal function. High creatinine blood level is an indicator of deficient filtering by the kidney. SCr was determined at baseline and various post-baseline time points.|Baseline (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n= participants who have both baseline and postbaseline values.|||mg/dL||Standard Deviation|Mean
2795242|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR During the LTE|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline (pretransplant time point), 1, 2, 3, 6,12, 18, 24, 30, 36 months posttransplant|ITT-LTE population, all randomized and transplanted participants who entered long term extension. n= participants who have both baseline and postbaseline values.|||mL/min/1.73 m^2||Standard Deviation|Mean
2795243|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline [BL] (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.|||mL/min/1.73 m^2||Standard Deviation|Mean
2795244|NCT00555321|Secondary|Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase|"GFR was assessed using a true measure of glomerular filtration via iothalamate clearance test. The month 2 time point was selected as the baseline time point with respect to measured GFR due to logistical difficulty in obtaining measured GFR at the time of liver transplant and post-transplant renal function largely stabilizing by 2 months. All Measured GFR > 200 were truncated at 200."|Baseline (2 month), 12 months posttransplant|ITT population: all randomized and transplanted subjects. n = participants who had both baseline and postbaseline values.|||mL/min/1.73m^2||Standard Deviation|Mean
2795245|NCT00555321|Secondary|Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months|The time from transplantation to the first AR episode in each treatment arm was summarized using Kaplan-Meier curves. Acute Rejections were clinically suspected and biopsy proven by central pathologist.|3, 6, 9 and 12 months posttransplant|ITT population, all randomized and transplanted participants.|||participants|||Number
2795246|NCT00555321|Secondary|Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|Day 1 (randomization) through End of study (database lock of 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered the long-term extension phase.|||participants|||Number
2795247|NCT00555321|Secondary|Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants|||participants|||Number
2795248|NCT00555321|Secondary|Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months|Acute Rejections (AR) were clinically suspected and biopsy proven by central pathologist. The Banff grading is a classification of renal allograft pathology and AR. Grade I: AR requiring moderate (>25%) to severe mononuclear cell interstitial infiltrate and moderate tubulitis; Grade II: AR requiring severe tubulitis and/or intimal arteritis; Grade III: AR requiring transmural arteritis. Only the episode with highest Banff grade for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants|||participants|||Number
2795249|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. DBL=database lock, TRT=treatment|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.|||participants|||Number
2795250|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. TRT= treatment|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants|||participants|||Number
2795251|NCT00555321|Secondary|Number of Participants Having Acute Rejections During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension|||participants|||Number
2795252|NCT00555321|Secondary|Number of Participants Having Acute Rejections: 12-month Treatment Phase|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|3 , 6, and 12 months|ITT population: all randomized and transplanted participants|||participants|||Number
2795253|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data)|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a central histopathologist using Banff criteria. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population: all randomized and transplanted participants who entered the Long term extension|||percentage of participants||95% Confidence Interval|Number
2795254|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% CI within each group, normal approximation is used if N>=5. Otherwise exact method is used. For 95% CI of difference, adjustment is made for randomization strata if N >= 5 in each treatment arm.|At 12 months posttransplant|ITT population: all randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2795255|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data)|For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.|||percentage of participants||95% Confidence Interval|Number
2795256|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase|For 95% CI within each group, normal approximation was used if N>=5. Otherwise exact method was used.|At 6 and 12 months|ITT population: all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
2795257|NCT00555321|Primary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N>=5, otherwise exact method is used.|At 6 months posttransplant|Intent-to-Treat (ITT) population: all randomized and transplanted participants.|||percentage of participants||95% Confidence Interval|Number
2795258|NCT00555217|Secondary|A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD.|Time to the first event of reduction in estimated GFR of >50% (for individuals with baseline GFR <60) or reduction in GFR of >30 (for individuals with baseline GFR >= GFR 60) or ESRD.|From enrollment to time of first event, up to 4.5 years||||participants|||Number
2795259|NCT00555217|Primary|A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death|Time to the first event of reduction in estimated GFR of 30ml/min/1.73m*m in individuals w/a baseline estimated GFR >= 60 ml/min/1.73m*m, reduction in estimated GFR >50% in individuals w/ baseline estimated GFR <60ml/min/1.73m*m; ESRD or death.|From enrollemnt to time of first primary event, up to 4.5 years||||participants|||Number
2795260|NCT00555152|Primary|Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0|Toxicity profile summarized reflects incidence by number of participants affected with adverse events by Maximum Grade 1 to 3, additional adverse event according to the NCI CTCAE version 3.0 reported in Adverse Event section results.|From baseline to 4-5 weeks after surgery||||participants|||Number
2795261|NCT00555152|Secondary|Biomarker Analysis of Proliferation Markers|Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, Up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.||||||
2795262|NCT00555152|Secondary|Incidence of Ductal Carcinoma in Situ Remaining at Resection|Number of participants with DCIS incidence on surgical excision. Differences in histologic response (disappearance of DCIS) will be evaluated using Fisher's exact test. Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, up to 6 weeks|DCIS was present at the time of surgery in all patients.|||participants|||Number
2795263|NCT00555152|Primary|Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS)|Reduction in percent of Ki67 positive cells at surgery compared to baseline as a function of treatment. Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant. Proliferation will be assessed by immunohistochemical (IHC) staining for Ki67, and the change in percentage of Ki67 positive cells will be compared in lapatinib-treated samples versus placebo.|2-6 weeks from baseline to surgery, up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.||||||
2795264|NCT00555061|Secondary|Number of Participants by Age With Therapeutic Response of Success|"Therapeutic response is a measure of the overall efficacy response; a response of therapeutic success was based on both clinical success and bacteriological success in a given participant."|Follow-up, Days 12 to 16|ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population; the number of participants who were therapeutic successes out of the total number in each respective category is shown.|||participants|||Number
2795265|NCT00555061|Secondary|Bacteriological Success Rate at Follow-up, by Baseline Pathogen|"Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as n in the category title) for each respective category is shown."|Follow-up, Days 12 to 16|ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline. Participants with more than one pathogen may be represented in the table more than once.|||number of pathogens eradicated|||Number
2795266|NCT00555061|Secondary|Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age|SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.|Follow-up, Days 12 to 16|Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication; the number of participants who were clinical successes out of the total number in each respective category is shown|||participants|||Number
2795267|NCT00555061|Primary|Number of Participants With Measurable Plasma Concentrations, by Age Group|Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.|Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day|Pharmacokinetic (PK) Population: all participants who received at least one dose of study medication and who had PK samples taken. Seven participants did not have PK samples collected.|||participants|||Number
2795268|NCT00555048|Secondary|Graft Failure|Count of participants with graft failure at day 100|Up to day 100||||Participants|||Count of Participants
2795269|NCT00555048|Secondary|Extensive Chronic GVHD|Count of participants with extensive chronic GVHD at 1 year|Up to 1 year||||Participants|||Count of Participants
2795270|NCT00555048|Secondary|Disease Relapse|Count of participants with disease relapse at 1 year|Up to 1 year||||Participants|||Count of Participants
2795271|NCT00555048|Secondary|Overall Survival|Count of surviving participants at 1 year|Up to 1 year||||Participants|||Count of Participants
2795272|NCT00555048|Secondary|Grades III-IV Acute Graft-vs-host Disease (GVHD)||Up to 100 days||||Participants|||Count of Participants
2795273|NCT00555048|Secondary|Life-threatening Infection||Up to 180 days||||Participants|||Count of Participants
2795274|NCT00555048|Primary|Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality|Lowest dose of alemtuzumab associated with transplant-related mortality at day 180|Up to day 180||||mg total dose|||Number
2795275|NCT00555009|Secondary|Change From Baseline in Waist Circumference||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||cm||Standard Deviation|Mean
2795276|NCT00555009|Secondary|Change From Baseline in Weight||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||kg||Standard Deviation|Mean
2795277|NCT00555009|Secondary|Change From Baseline in Cardiovascular Risk|The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).|Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
2795278|NCT00555009|Secondary|Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36|The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 'Yes' or 'No' statements covering 6 dimensions - mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
2795279|NCT00555009|Secondary|Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36|A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||score on a scale||Standard Deviation|Mean
2795280|NCT00555009|Secondary|Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36|The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
2795281|NCT00555009|Secondary|Change From Baseline in Lean Body Mass and Fat Mass at Week 36|The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||kg||Standard Deviation|Mean
2795282|NCT00555009|Secondary|Change From Baseline in CogState™ at Week 12 and 24.|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 12 and 24|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
2795283|NCT00555009|Primary|Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.|||scores on a scale||Standard Deviation|Mean
2795284|NCT00554996|Primary|Rate of UTI While Colonized With E. Coli 83972.|Rate of UTI during colonization with E. coli 83972.|0-266 days of colonization|Number of UTIs per 1000 patient-days during colonization with E. coli 83972.|||UTIs per 1000 patient-days|||Number
2795285|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.|||min||Standard Deviation|Mean
2795286|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.|||min||Standard Deviation|Mean
2795287|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg*min/ml||Standard Deviation|Mean
2795288|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg*min/ml||Standard Deviation|Mean
2795289|NCT00554970|Primary|Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Mean
2795290|NCT00554970|Primary|Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Mean
2795291|NCT00554853|Secondary|Rheumatoid Arthritis Disease Activity|"Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)).~Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood."|8 mo||||mean decrease in DAS28-CRP score||Standard Deviation|Mean
2795292|NCT00554853|Primary|Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia|This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study.|8 months|Vascular function parameters were performed in patients with rheumatoid arthritis at baseline and at completion of each arm , as well as at the beginning of crossover following washout period.|||% changes in diameter of artery||Inter-Quartile Range|Mean
2795293|NCT00554840|Secondary|Side Effects|Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.|Weekly for 12 weeks||||Participants|||Count of Participants
2795294|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score|"The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS anxiety/depression score data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
2795295|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS total score data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
2795296|NCT00554840|Secondary|Brief Psychiatric Rating Scale (BPRS) - Total Score|"The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.|Some BPRS total score data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
2795297|NCT00554840|Primary|Level of Nicotine Dependence by Treatment Assignment|Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.|Weekly for 12 weeks|Some FTND data is missing due to rater error or participant absence from that study visit.|||units on a scale||Standard Deviation|Mean
2795298|NCT00554840|Primary|Change of ExpiredCO Level From Baseline|End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.|Weekly for 12 weeks|Some ExpiredCO data is missing due to rater error or participant absence from that study visit.|||ppm||Standard Deviation|Mean
2795299|NCT00554801|Secondary|Quality of Life Questionnaire|Self-report questionnaires regarding quality of life|Three years|It was decided early during implementation of this study that the investigators would not collect self-report data on quality of life, so there are no data to report||||||
2795300|NCT00554801|Primary|Audiological Test Results|Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.|three years||||decibels Hearing Level||Standard Deviation|Mean
2795301|NCT00554788|Secondary|Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Grade 3 and higher toxicities will be descriptively summarized.|Up to 30 days after completion of study treatment|Three ineligible patients were excluded from this analysis. Two patients who did not receive therapy were also excluded from this analysis.|||percentage of participants|||Number
2795302|NCT00554788|Secondary|Response Rate to the Induction Phase of the Regimen|This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined.|12 weeks after participant received the first dose|Ineligible patients were excluded from analysis|||percentage of participants||95% Confidence Interval|Number
2795303|NCT00554788|Primary|Event-free Survival (EFS)|The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.|At 1 year|Ineligible patients were excluded from analysis|||Probability||95% Confidence Interval|Number
2795304|NCT00554749|Secondary|Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)|6 Predefined treatment goals reflecting speaking levels from 1 through to 6. 1: Speaks to the therapist(T) in a separate room in the kindergarten with parent (P) present. 2: Speaks to T in a separate room without P. 3: Speaks to a teacher in a separate room with T present. 4: Speaks to other teachers in a separate room with T present. 5: Speaks to teachers in some kindergarten settings without T present. 6: Speaks to teachers in all settings in kindergarten without T present. Each child receives one score at end of treatment according to their acquired level (worst value=1, best value =6)|6 months|All participants analyzed|||participants|||Number
2795305|NCT00554749|Primary|School Speech Questionnaire (SSQ)|SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)|6 months||||Units on a scale||Standard Deviation|Mean
2795306|NCT00554671|Secondary|Health-care Costs to the VHA|"The reported values represent the Total VHA expenditure per person. Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0."|13 months (during study) and 13 months (after the study) = 26 months|117 patients randomized to Pharmacist-led Group Medical Visits. 133 patients were randomized to Usual care.|||United States Dollar||Standard Deviation|Mean
2795307|NCT00554671|Secondary|Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment|Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health.|Baseline and 13 months|117 patients randomized to Pharmacist-led Group Medical Visits, 2 patients died before study end date and 18 patients dropped out.133 patients randomized to Usual care, 4 patients died before study end date and 12 patients dropped out.|||Scores of SF-36v||Standard Deviation|Mean
2795308|NCT00554671|Primary|Hemoglobin A1c|hemoglobin A1c levels at 13 months|13 months||||percent Hemoglobin A1c||Standard Deviation|Mean
2795309|NCT00554671|Primary|Hemoglobin A1c|Hemoglobin A1c levels at 6 months|6 months|At the 6 month visit, some patients dropped out of the study or died.|||percent Hemoglobin A1c||Standard Deviation|Mean
2795310|NCT00554619|Primary|Number of Participants With Adverse Events Categorized by Severity|The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.|For 140.57 weeks at maximum, starting from Week 24|Safety Population|||participants|||Number
2795311|NCT00554619|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. BNP is a surrogate marker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||nanograms per liter (ng/L)||Standard Deviation|Mean
2795312|NCT00554619|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|CO is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||Liters per minute (L/min)||Standard Deviation|Mean
2795313|NCT00554619|Secondary|Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|mPAP is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2795314|NCT00554619|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event|Time to clinical worsening was defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy (a surgical procedure in which a small hole is made in the wall between the left and right atria of the heart), or study discontinuation due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events up to 164.14 weeks.|Up to 164.14 weeks|FAS|||participants|||Number
2795315|NCT00554619|Secondary|Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|There are four grades for the WHO FC (Class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||participants|||Number
2795316|NCT00554619|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.|||scores on a scale||Standard Deviation|Mean
2795317|NCT00554619|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 minus the baseline value. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Imputation technique was last observation carried forward, which was used in an attempt to compensate for missing data. For each participant, missing values were replaced with the last observed value.|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Full Analysis Set (FAS): All participants registered, with the exception of those who did not receive any dose of the investigational product and those who had no efficacy assessment after treatment.|||meters||Standard Deviation|Mean
2795318|NCT00554619|Primary|Number of Participants With Any Adverse Event|An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.|For 140.57 weeks at maximum, starting from Week 24|Safety Population: Participants who had received at least one dose of the investigational product|||participants|||Number
2795319|NCT00554515|Post-Hoc|Objective Response Rate (Investigator Assessment)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
2795320|NCT00554515|Post-Hoc|KIR Genotype Status|Killer-immunoglobulin-like receptor (KIR) genotype status determined based on establish methods.|Determined from baseline sample.||2020-12-31|12/2020||||
2795321|NCT00554515|Post-Hoc|Serum Arginine Levels|Serum arginine levels will be determined based on establish immunohistochemical methods.|Determined from baseline sample.||2020-12-31|12/2020||||
2795322|NCT00554515|Other Pre-specified|VHL Genotype Status|VHL genotype status will be determined based on establish methods.|Determined from baseline sample.||2020-12-31|12/2020||||
2795323|NCT00554515|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from treatment start to date of disease progression (PD) or death. Per WHO criteria: PD is a >/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. Participants who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Median survival follow-up was X months (95% CI: ).|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2795324|NCT00554515|Secondary|Objective Response Rate by CA-9 SNP|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795325|NCT00554515|Secondary|Objective Response Rate by B7-H3 Tumor|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795332|NCT00554515|Secondary|3-Year Progression-Free Survival Rate|3-year progression-free survival rate is defined as the proportion of patients absent death or progression based on WHO criteria by 3 years since time of treatment start. PD is a >/=25% increase in the sum of products of the perpendicular diameters of all measurable lesions. Further, PD is the appearance of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Relevant for this endpoint was disease status at 3 y.|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
2795609|NCT00552240|Secondary|Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities||baseline to week 52|All treated patients|||participants|||Number
2795326|NCT00554515|Secondary|Objective Response Rate by PD-L1 Tumor|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of patients||95% Confidence Interval|Number
2795327|NCT00554515|Secondary|Objective Response Rate by CA-9 Score (CAIX Classification)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795328|NCT00554515|Secondary|Objective Response Rate by Clear Cell Histology Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Response status was confirmed by an independent assessment of radiographs. Participants received up to 3 courses of 12 weeks duration each.|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795329|NCT00554515|Secondary|Objective Response Rate by Tumor Type|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795330|NCT00554515|Secondary|Objective Response Rate by UCLA SANI Score|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795331|NCT00554515|Secondary|Objective Response Rate by MSKCC Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data.|||proportion of participants||95% Confidence Interval|Number
2795610|NCT00552240|Secondary|Proportion of Patients Reporting Rash of Any Severity||baseline to week 52|All treated patients|||participants|||Number
2795333|NCT00554515|Secondary|Overall Survival|Overall survival based on the Kaplan-Meier method is defined as the time from treatment start to date of death or censored at the date of last documented contact.|Participants were followed for survival up to 7 years.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2795334|NCT00554515|Secondary|Objective Response Rate (Independent Assessment)|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks.. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
2795335|NCT00554515|Secondary|Objective Response Rate in ISM Poor Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on treatment on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by independent assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM poor risk.|||proportion of participants||95% Confidence Interval|Number
2795336|NCT00554515|Primary|Objective Response in ISM Good Risk Group|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. [Miller et al. Cancer 1981] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a >/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.|Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).|The analysis dataset is comprised of all treated patients with available tumor tissue/data for ISM analysis and classified as ISM good risk.|||proportion of participants||95% Confidence Interval|Number
2795337|NCT00554463|Secondary|Progression-free Survival|Progression is defined as any failure per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Due to early termination with few patients, only counts of events have been calculated.|From registration to last follow-up, a maximum of 32.9 months|All registered patients|||Participants|||Count of Participants
2795338|NCT00554463|Secondary|Overall Survival|Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Due to early termination with few patients, only counts of events have been calculated.|From registration to last follow-up, a maximum of 32.9 months|All registered patients|||Participants|||Count of Participants
2795339|NCT00554463|Secondary|Number of Patients With Grade 4 Thrombocytopenia|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.|From registration to last follow-up, a maximum of 32.9 months|All registered patients|||Participants|||Count of Participants
2795340|NCT00554463|Secondary|Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.|From registration to last follow-up, a maximum of 32.9 months|All registered patients|||Participants|||Count of Participants
2795341|NCT00554463|Secondary|Number of Patients With Dose Modifications or Treatment Delays||From start of treatment to end of treatment, for a maximum of 66 days|All registered patients|||Participants|||Count of Participants
2795342|NCT00554463|Secondary|Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant Chemoradiotherapy|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.|From the start to the end of adjuvant chemotherapy, a maximum of 24 days|All registered patients|||Participants|||Count of Participants
2795611|NCT00552240|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity||baseline to week 52|All treated patients|||participants|||Number
2795343|NCT00554463|Primary|Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.|From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days|All registered patients|||Participants|||Count of Participants
2795344|NCT00554372|Secondary|Median Overall Survival|Overall survival after treatment in days|To 760 days post treatment||||days||95% Confidence Interval|Median
2795345|NCT00554372|Secondary|Number of Subjects Achieving Disease Control as Determined Using Intrahepatic Modified RECIST Criteria|"Number of subjects achieving disease control (non-progressive disease) at 8 weeks after treatment was initiated based on modified Response Evaluation Criteria in Solid Tumors for Hepatocellular Carcinoma (mRECIST for HCC). mRECIST for HCC adopted the concept of viable tumor as tumor tissue showing uptake in arterial phase of contrast enhanced radiologic imaging techniques. (see Lencioni and Llovet, Semin. Liver Dis. 2010; 30:52-60). Per mRECIST for HCC, for target lesions as assessed by contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target (viable) lesions; Partial Response (PR), >=30% decrease in the sum of diameters of viable target lesions; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in viable target lesions.~Disease Control (DC) = CR or PR or SD."|At week 8||||participants|||Number
2795346|NCT00554372|Secondary|Safety and Tolerability of JX-594 Administered at Two Dose Levels|Treatment-related serious adverse events in patients treated at two dose levels|Safety and tolerability were evaluated throughout the 8 week period of study participation||||serious adverse event|||Number
2795347|NCT00554372|Primary|Proportion of Subjects Achieving Disease Control (Non-progressive Disease) at 8 Weeks After Initiation of Treatment|Proportion of subjects achieving disease control at 8 weeks based on a modified Response Evaluation Criteria in Solid Tumors v1.0 (mRECIST). Per mRECIST for target lesions as assessed by dynamic contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of all tumor(s); Partial Response (PR), >=30% decrease in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum. Disease Control (DC) = CR or PR or SD. For mRECIST criteria, new tumor(s) that developed within the liver were measured (a new tumor was defined as a malignant tumor not present at baseline, was ≥ 1 cm in LD had typical hypervascular features of HCC). Their maximum diameter(s) were included in the sum of the maximum diameter; new tumors were not considered evidence for progression.|Initial progression status and response assessment at 8 weeks from first dose|Patients having evaluable radiographic imaging, 2 patients in each arm were excluded due to unevaluable images, 1 patient in the low dose arm was excluded due to a protocol deviation|||Proportion of evaluable participants||95% Confidence Interval|Number
2795348|NCT00554294|Secondary|Parameters of Process Evaluation (Acceptance, Feasibility)||1,5 years|||||||
2795349|NCT00554294|Secondary|Water Flow of the Water Dispensers||one school year|||||||
2795350|NCT00554294|Secondary|Physical Activity and Inactivity||one school year|||||||
2795351|NCT00554294|Secondary|Intake of Drinks||one school year|||||||
2795352|NCT00554294|Primary|Overweight|Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)|one school year||||participants|||Number
2795353|NCT00554229|Secondary|Pharmacokinetic Characteristics of ZD4054||PK samples were performed at randomisation, Week 4, Week 8 and Week 12|||||||
2795354|NCT00554229|Secondary|Time to Initiation of Chemotherapy|Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
2795355|NCT00554229|Secondary|Time to Pain Progression|Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
2795356|NCT00554229|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
2795357|NCT00554229|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|Patients were assessed at every visit||||Months||Inter-Quartile Range|Median
2795358|NCT00554229|Secondary|Bone Metastases Formation|Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method|Patients were assessed every 12 weeks||||Months||Inter-Quartile Range|Median
2795359|NCT00554229|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method.|From date of randomization until occurrence of a skeletal related event, assessed up to 31 months||||Months||Inter-Quartile Range|Median
2795360|NCT00554229|Secondary|Time to Use of Opiates|Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method|From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months||||Months||Inter-Quartile Range|Median
2795612|NCT00552240|Secondary|Proportion of Patients Reporting CNS Side Effects of Any Severity||baseline to week 52|All treated patients|||participants|||Number
2795361|NCT00554229|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline, using the Kaplan-Meier method|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months||||Months||Inter-Quartile Range|Median
2795362|NCT00554229|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method|From date of randomization until date of death, assessed up to 32 months||||months||Full Range|Median
2795363|NCT00554216|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percentage of participants|||Number
2795364|NCT00554216|Primary|Percent Weight Loss From Baseline to Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
2795365|NCT00554190|Primary|Number of Participants With Solicited and Recorded Adverse Events|All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.|Post-operative through 60 days|There were 19 participants who completed the 60 day follow up visits for analysis.|||Participants|||Number
2795366|NCT00554190|Primary|Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale|Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment.|Post-operative through 60 days|There were 19 participants that completed the final follow-up visit at 60 days.|||Participants|||Number
2795367|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 52|At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).|52 Weeks|ITT Population|||Percentage of Participants|||Number
2795368|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 12|At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).|12 Weeks|ITT Population|||Percentage of Participants|||Number
2795369|NCT00554099|Secondary|Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12||12 Weeks|ITT Population|||Percentage of Participants|||Number
2795370|NCT00554099|Secondary|Change in GSS From Baseline to Week 52 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 52|ITT Population|||Scores on a Scale||Standard Error|Mean
2795371|NCT00554099|Secondary|Change in GSS From Baseline to Week 12 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 12|ITT Population|||Scores on a Scale||Standard Error|Mean
2795372|NCT00554099|Secondary|Percentage of Responders at Week 52 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|52 Weeks|ITT Population|||Percentage of Participants|||Number
2795373|NCT00554099|Secondary|Percentage of Responders at Week 12 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|ITT Population|||Percentage of Participants|||Number
2795374|NCT00554099|Primary|Global Symptom Score (GSS) at Week 12, Primary Efficacy Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.|||Scores on a Scale||Standard Error|Mean
2795375|NCT00553969|Primary|Change in Disease Score (DS) Among the Treatment Groups|Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.|Baseline and nine months|Calculation for change is the value at the later time point minus the value at the earlier time point.|||Overall Rasmussen Disease Score Change||Standard Deviation|Mean
2795376|NCT00553839|Primary|Residual Error|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Residual Error was analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease|||proportional %||95% Confidence Interval|Median
2795395|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2795377|NCT00553839|Primary|Central and Peripheral Volume of Distribution|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Central and Peripheral Volume of Distribution were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease|||L/70kg||95% Confidence Interval|Median
2795378|NCT00553839|Primary|Total Clearance and Intercompartmental Clearance|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease|||L/h/70kg||95% Confidence Interval|Median
2795379|NCT00553787|Primary|Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percentage of participants|||Number
2795380|NCT00553787|Primary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
2795381|NCT00553735|Secondary|Schirmer With Anesthesia||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
2795382|NCT00553735|Secondary|Schirmer Without Anesthesia||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
2795383|NCT00553735|Secondary|Tear Break-up Time (TBUT)||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
2795384|NCT00553735|Secondary|Symptom Assessment iN Dry Eye (SANDE) Patient Questionnaire||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
2795385|NCT00553735|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.|18 Months|All patients enrolled in the study were analyzed.|||participants|||Number
2795386|NCT00553735|Primary|Conjunctival Staining Score||18 Months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
2795387|NCT00553735|Primary|Corneal Staining Score||18 months|No data were collected because participants withdrew themselves, failed to show for their appointments, or were lost to follow-up.||||||
2795388|NCT00553696|Secondary|Time to Progression (TTP)|Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).|||Months||95% Confidence Interval|Median
2795389|NCT00553696|Secondary|Progression-Free Survival (PFS)|Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).|||Months||95% Confidence Interval|Median
2795390|NCT00553696|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).|Baseline up to 739 days|A subgroup of participants with an objective tumor response among Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)|||Months||95% Confidence Interval|Median
2795391|NCT00553696|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).|||participants|||Number
2795392|NCT00553696|Secondary|Number of Participants With Objective Response|Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)|||participants|||Number
2795393|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||ng*h/mL||Standard Deviation|Mean
2795394|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||hrs||Full Range|Median
2795613|NCT00552240|Secondary|Incidence of Patients With AIDS Progression at Each Visit|Cumulative incidence of patients with AIDS progression are shown|baseline to week 52|Full Analysis set|||participants|||Number
2795396|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||ng*h/mL||Standard Deviation|Mean
2795397|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||hrs||Full Range|Median
2795398|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2795399|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||ng*h/mL||Standard Deviation|Mean
2795400|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||hrs||Full Range|Median
2795401|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2795402|NCT00553696|Primary|Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)|A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).|Cycle 1 (Baseline to Week 4)|DLT Evaluation Set consisted of participants who were initially enrolled for the determination of maximam tolerated dose (MTD), and either 'experienced DLT' or 'received all of the Day 1 chemotherapy, received at least 80% of their sunitinib doses, and at least 80% of S-1 doses'.|||participants|||Number
2795403|NCT00553644|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry until death. The median OS with 95% CI was estimated using the Kaplan-Meier method..|Assessed up to 6 years||||years||95% Confidence Interval|Median
2795404|NCT00553644|Secondary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death due to any cause. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Assessed up to 6 years||||years||95% Confidence Interval|Median
2795405|NCT00553644|Secondary|Incidence of Adverse Events|Number of participants who experienced a maximum grade 3, 4 or 5 adverse event. The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting|Duration of Treatment (up to 6 years)||||participants|||Number
2795406|NCT00553644|Primary|Number of Participants With an Overall Response Defined as Complete Response and Partial Response|"Response is assessed by investigator according to International Working Group (IWG) criteria.~A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease."|Duration of treatment (assessed up to 6 years)||||participants|||Number
2795407|NCT00553631|Secondary|Time to Response- Comparison of GA-GCB and Imiglucerase on the Earliest Time to Respond as Assessed Via Hemoglobin Concentration|Time to response was defined as a ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline. Units (%) correlates to the percentage of participants who had a change of ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline during their participation in the study.|Response rate at Month 9 compared to Baseline|ITT population|||Percentage of participants|||Number
2795408|NCT00553631|Secondary|Number of Participants Who Developed Antibody for Each Treatment Group.|Measure type is actual number of participants who developed antibodies to treatment; GA-GCB or imiglucerase. Antibody detection was based upon serum samples collected at various time points throughout the study. Serum samples were screened using an enzyme-linked immunosorbent assay (ELISA) and positive antibody confirmation was determined using a radioimmunoprecipitation assay (RIP); positive samples were also tested for enzyme neutralizing activity. Participant samples were compared to internal assay controls (positive/negative), positive samples were determined based upon individual assay criteria.|Baseline to Month 9|Safety population comprised of all randomized participants who received at least 1 full or partial dose of study drug.|||participants|||Number
2795409|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chemokine (C-C Motif) Ligand 18 (CCL18) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.|||nanogram per milliliter (ng/mL)||Standard Error|Mean
2795410|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chitotriosidase for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Units of measure is defined as nanomole per milliliter per hour.|Baseline to Month 9.|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Chitotriosidase levels were measured in 10 participants in the velaglucerase alfa group and 11 participants in the imiglucerase group.|||nanomole/milliliter/hour (nmol/mL/h)||Standard Error|Mean
2795411|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Spleen Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to month 9. Measured by Magnetic resonance imaging (MRI). Spleen volume was normalized for percent (%) of body weight for each treatment arm. Spleen size relative to body weight=(Spleen volume [cc]/Body weight [kg])*100.|Baseline to Month 9|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Ten participants in each treatment group underwent splenectomy, and therefore, were excluded from the analysis.|||cm^3||Standard Error|Mean
2795412|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Liver Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Measured by Magnetic resonance imaging (MRI). Liver volume has been normalized for percent (%) body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cubic centimeter (cc)]/Body weight [kg]*1000.|Baseline to Month 9|ITT population.|||cubic centimeter (cm^3)||Standard Error|Mean
2795413|NCT00553631|Secondary|Change From Baseline to Month 9 in Platelet Counts for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.|||10^9 per liter (10^9/L)||Standard Error|Mean
2795414|NCT00553631|Primary|Mean Change From Baseline to Month 9 in Hemoglobin (Hgb) Concentration for Each Treatment Group.||Baseline to Month 9|Intent-to-treat (ITT) population comprised of all randomized participants who received at least 1 full or partial dose of study drug.|||gram per deciliter (g/dl)||Standard Error|Mean
2795415|NCT00553605|Secondary|Number of Participants With Use of Rescue Medication (RM)|Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.|Up to Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.|||participants|||Number
2795416|NCT00553605|Secondary|Physician's Global Evaluation of Study Medication|"Physicians' response to the question How would you rate the study medication the patient received for pain? on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated."|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2795417|NCT00553605|Secondary|Patient's Global Evaluation of Study Medication|"Participants' response to the question How would you rate the study medication you received for pain? on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated."|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2795418|NCT00553605|Secondary|Number of Participants With Response in Pain Intensity|"PI-VAS assessed with response to the question How much pain are you having right now? on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm."|Minute 30|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2795419|NCT00553605|Secondary|Number of Participants With Pain Relief (PR)|PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||participants|||Number
2795420|NCT00553605|Secondary|Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)|TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|Baseline through Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
2795421|NCT00553605|Secondary|Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120|"PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question How much pain are you having right now? on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain."|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time points for each treatment arm respectively.|||mm||Standard Deviation|Mean
2795422|NCT00553605|Secondary|Time-specific Pain Intensity (PI) VAS Score|"PI-VAS assessed with response to the question How much pain are you having right now? on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain."|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||mm||Standard Deviation|Mean
2795423|NCT00553605|Secondary|Mean Pain Intensity Difference at 120 Min (mPID120min)|"mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question How much pain are you having right now? on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain."|Minute 120|Modified intent- to-treat (mITT) included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.|||mm||Standard Error|Least Squares Mean
2795438|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795455|NCT00553475|Primary|Change From Baseline at Week 10 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.~Change from baseline: Score at Week 10 minus score at baseline"|From baseline to Week 10|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795424|NCT00553605|Primary|Mean Pain Intensity Difference at 30 Minutes (mPID30min)|"mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question How much pain are you having right now? on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain."|Minute 30|Per-protocol (PP): all randomized participants who received at least 1 dose of study drug; had 1 post-baseline pain assessment; no major protocol violations; received appropriate dose of study drug; had valid baseline, 15 and 30 min VAS pain assessments; did not take rescue medications for 30 min; had confirmed diagnosis of nephrolithiasis.|||mm||Standard Error|Least Squares Mean
2795425|NCT00553540|Primary|Change in Low Back Pain|numeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24. Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24.|6 months||||units on a scale||Full Range|Mean
2795426|NCT00553514|Secondary|Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm||Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Follicles||Standard Deviation|Mean
2795427|NCT00553514|Secondary|Cumulative Dose of Supplemental Follitropin Alfa Administered||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||IU||Standard Deviation|Mean
2795428|NCT00553514|Secondary|Duration of Supplemental Follitropin Alfa Treatment||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
2795429|NCT00553514|Secondary|Duration of Ovarian Stimulation|Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).|Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
2795430|NCT00553514|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percentage of participants|||Number
2795431|NCT00553514|Primary|Percentage of Participants With Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level >= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter [ng/mL]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.|Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])|Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percentage of participants|||Number
2795432|NCT00553501|Post-Hoc|3-Year Overall Survival|Percentage of participants who were alive at 3 years. The 3 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|3 years||||percentage of participants||95% Confidence Interval|Number
2795433|NCT00553501|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||years||95% Confidence Interval|Median
2795434|NCT00553501|Primary|Number of Participants With Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.~CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions"|12 months||||participants|||Number
2795435|NCT00553475|Primary|Change From Baseline at Week 13 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.~Change from baseline: Score at Week 13 minus score at baseline"|From baseline to Week 13|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795436|NCT00553475|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
2795437|NCT00553475|Secondary|Clinical Global Impression of Change|Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
2795639|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients|||Participants|||Number
2795439|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795440|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795441|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795442|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795443|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795444|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795445|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795446|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||mm||Standard Error|Least Squares Mean
2795447|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795448|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795449|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795450|NCT00553475|Secondary|Change From Baseline in Mean Sleep Interference Scores|The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795451|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795452|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795453|NCT00553475|Primary|Change From Baseline at Week 12 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.~Change from baseline: Score at Week 12 minus score at baseline"|From baseline to Week 12|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795454|NCT00553475|Primary|Change From Baseline at Week 11 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.~Change from baseline: Score at Week 11 minus score at baseline"|From baseline to Week 11|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795456|NCT00553475|Primary|Change From Baseline at Week 9 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.~Change from baseline: Score at Week 9 minus score at baseline"|From baseline to Week 9|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795457|NCT00553475|Primary|Change From Baseline at Week 8 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.~Change from baseline: Score at Week 8 minus score at baseline"|From baseline to Week 8|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795458|NCT00553475|Primary|Change From Baseline at Week 7 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.~Change from baseline: Score at Week 7 minus score at baseline"|From baseline to Week 7|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795459|NCT00553475|Primary|Change From Baseline at Week 6 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.~Change from baseline: Score at Week 6 minus score at baseline"|From baseline to Week 6|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795460|NCT00553475|Primary|Change From Baseline at Week 5 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.~Change from baseline: Score at Week 5 minus score at baseline"|From baseline to Week 5|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795461|NCT00553475|Primary|Change From Baseline at Week 4 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.~Change from baseline: Score at Week 4 minus score at baseline"|From baseline to Week 4|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795462|NCT00553475|Primary|Change From Baseline at Week 3 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.~Change from baseline: Score at Week 3 minus score at baseline"|From baseline to Week 3|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795463|NCT00553475|Primary|Change From Baseline at Week 2 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.~Change from baseline: Score at Week 2 minus score at baseline"|From baseline to Week 2|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795464|NCT00553475|Primary|Change From Baseline at Week 1 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.~Change from baseline: Score at Week 1 minus score at baseline"|From baseline to Week 1|Full analysis set. Observed case (No imputation).|||score on scale||Standard Error|Least Squares Mean
2795465|NCT00553475|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||participants|||Number
2795466|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795467|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795468|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795469|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795470|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795471|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795472|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795473|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2795474|NCT00553462|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)||||months||95% Confidence Interval|Median
2795475|NCT00553462|Secondary|Response Rate|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved each response."|Duration of study (up to 2 years)||||percentage of participants|||Number
2795476|NCT00553462|Primary|Overall Survival at 12 Months|Percentage of participants who were alive at 12 months.|At 12 months||||percentage of participants||95% Confidence Interval|Number
2795477|NCT00553436|Primary|Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)|Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.|At The Time of Surgery|All enrolled subjects were analyzed|||participants|||Number
2795478|NCT00553436|Secondary|Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition||3 month follow-up|All enrolled subjects were analyzed|||Participants|||Number
2795479|NCT00553436|Secondary|Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.|The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.|3 month follow-up||||participants|||Number
2795480|NCT00553410|Secondary|Breast Cancer-free Interval|Duration of time from randomization to the first indication of the following events: invasive breast recurrence at local, regional or distant sites; a new invasive cancer in the contralateral breast (second non-breast malignancies are ignored). In the absence of an event, BCFI was censored at the date of last follow-up visit or date of death without prior breast cancer event.|5-year estimates, reported at a median follow-up of 60 months|Intention-to-treat|||percentage of patients||95% Confidence Interval|Number
2795481|NCT00553410|Secondary|Distant Recurrence-free Interval (DRFI)|"Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.*~*This endpoint replaced DDFS, which was specified in the protocol"|5-year estimates, reported at a median follow-up of 60 months|Intention-to-treat|||percentage of patients||95% Confidence Interval|Number
2795482|NCT00553410|Secondary|Overall Survival|Duration of time from randomization to death from any cause, or was censored at the date last known alive. (Note, for patients who withdrew consent or were lost to follow-up but follow-up for survival was possible through hospital or registry records, OS was censored at the date last known alive rather than date of last follow-up/withdrawn consent).|5-year estimates, reported at a median follow-up of 60 months|Intention-to-treat|||percentage of patients||95% Confidence Interval|Number
2795483|NCT00553410|Primary|Disease-free Survival (DFS)|Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.|5-year estimates, reported at a median follow-up of 60 months|Intention-to-treat|||percentage of patients||95% Confidence Interval|Number
2795484|NCT00553358|Secondary|Number of Circulating Tumor Cells (CTC) in the Bloodstream|Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks. Data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2 of neo-adjuvant phase (Weeks 1-34), at surgery (Weeks 20 to 22), Week 10 of adjuvant phase, 6 months after completion of adjuvant treatment, and at recurrence||2021-08-31|08/2021||||
2795485|NCT00553358|Secondary|Number of Participants With the Indicated Biomarker Expression|Biomarker levels (Ki67, p27, Cyclin-D1, ErbB1, ErbB2, ErbB3, pErbB1, pErbB2, Akt and pAkt, S6 and pS6, MAPK and pMAPK, c-myc, IGFR1, p95HER2, PTEN, ER (alpha, beta), PgR,CD34, terminal deoxynucleotidyl transferase biotin-dUTP nick and labelling technique [TUNEL] and topoisomerase II) were assessed in participants. Blood and tumor tissue samples were collected at Baseline and at Weeks 2 and 20-22; however, data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2, and at surgery (Weeks 20 to 22)||2021-08-31|08/2021||||
2795501|NCT00553332|Primary|Objective Response Rate (CR and PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 8 weeks||||patients|||Number
2795486|NCT00553358|Secondary|Number of Participants With Metabolic Response of Complete Response (mCR), Partial Response (mPR), or Stable Disease (mSD) as Determined by Positron Emission Tomography/Computed Tomography (PET/CT)|European Organisation for Research and Treatment of Cancer recommendations were used to define metabolic response. mCR, complete metabolic response: complete resolution of fludeoxyglucose uptake within tumor, indistinguishable from surrounding normal tissue. mPR, partial metabolic response: reduction of more than 25% of maximum tumor standard uptake value (SUV). mSD, stable metabolic disease: increase of <25% in tumor SUV or decrease of >20% in tumor SUV. mPD, progressive metabolic disease: increase of >25% in tumor SUV or >20% in the extent (longest dimension) or appearance of new metastases.|Baseline, Week 2, and Week 6||2021-08-31|08/2021||||
2795487|NCT00553358|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from surgery to the first date of breast cancer relapse, second primary tumor (including contralateral breast cancer), or death without documented prior relapse. Data will be reported when they are mature and available, likely when a median of 3 years follow up has been reached.|Following surgery, every 12 months until Year 10||2020-12-31|12/2020||||
2795488|NCT00553358|Secondary|Overall Survival|Overall survival was defined as the period from surgery until death (from any cause). Data will be reported when they are mature and available; OS is assessed annually for up to 10 years after the randomization of the last participant into the study.|Following surgery, every 12 months until Year 10||2020-01-31|01/2020||||
2795489|NCT00553358|Secondary|Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab|Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel.|Week 6|ITT Population. Participants who did not start any treatment were excluded from analysis.|||participants|||Number
2795490|NCT00553358|Secondary|Estimate of Treatment Contrast for Change From Baseline in Tumor Size at Week 6 and at Surgery|Estimate of treatment contrast is defined as the estimate of the difference between treatment groups in the change from baseline in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg.|Week 6 and surgery (Weeks 20 to 22)|ITT Population|||millimeters||Standard Deviation|Mean
2795491|NCT00553358|Secondary|Number of Participants With Actual Indicated Surgery|Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable.|At surgery (Weeks 20 to 22)|ITT Population|||participants|||Number
2795492|NCT00553358|Secondary|Number of Participants With Negative Lymph Nodes at the Time of Surgery|Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis.|Time of surgery (Weeks 20 to 22)|ITT Population. Participants with a lymph node status of pNX (i.e., regional lymph nodes cannot be assessed) were omitted from the analysis of node-negative participants.|||participants|||Number
2795493|NCT00553358|Secondary|Number of Participants With Overall Response at the Time of Surgery|The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Time of surgery (Weeks 20 to 22)|ITT Population|||participants|||Number
2795494|NCT00553358|Secondary|Number of Participants With Overall Response at Week 6|The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Week 6|ITT Population|||participants|||Number
2795495|NCT00553358|Primary|Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery|Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.|Weeks 20 to 22|Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication|||participants|||Number
2795496|NCT00553332|Secondary|Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation|Measure the proteins levels of RAS/RAF/MEK/ERK signaling pathway activation to AZD6244|At baseline|Only 27 patients had pAKT and pERK performed due to 2 samples not available for analysis|||mg/ml||Standard Deviation|Mean
2795497|NCT00553332|Secondary|RAS/RAF/MEK/ERK Signaling Pathway Activation||At baseline|Data was not collected and analyzed||||||
2795498|NCT00553332|Secondary|Overall Survival||Up to 12 months|Kaplan-Meier|||months||95% Confidence Interval|Median
2795499|NCT00553332|Secondary|Median Progression Free Survival for Patients|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 6 months||||months||95% Confidence Interval|Median
2795500|NCT00553332|Secondary|Toxicity Profile of AZD6244|Toxicitity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|From the time of first treatment with AZD6244, assessed up to 4 weeks||||percent of patients|||Number
2795503|NCT00553319|Primary|Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use|Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE <300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.|weekly for 14 weeks of trial or for length of participation||||percentage of participants|||Number
2795504|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
2795505|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||mm||Standard Deviation|Mean
2795506|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
2795507|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
2795508|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.|||score on scale||Standard Deviation|Mean
2795509|NCT00553280|Primary|Summary of Adverse Events|Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.|53 weeks|Safety analysis set: all participants who had received at least one dose of the study drug.|||participants|||Number
2795510|NCT00553267|Secondary|Peripheral Oedema Incidence Rate|The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)|During randomised treatment period||||Number of cases/100 patient-years|||Number
2795511|NCT00553267|Secondary|Oedema Incidence Rate|The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)|During randomised treatment period|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Number of patients/100 patient-years|||Number
2795512|NCT00553267|Secondary|Trough Seated BP Normality Classes|The number of patients who reach predefined BP categories|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
2795513|NCT00553267|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
2795514|NCT00553267|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
2795515|NCT00553267|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
2795516|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure <80 mmHg|The number of patients who reach the target DBP of <80mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
2795517|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||Participants|||Number
2795518|NCT00553267|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2795519|NCT00553267|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2795640|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients|||Participants|||Number
2795520|NCT00553202|Other Pre-specified|Time to the Donor-specific NK-cell Receptor Expression|The presence of donor cells is demonstrated by the detection of informative variable-number tandem-repeat polymorphisms or by fluorescent in situ hybridization with a Y-chromosome-specific probe in cases of sex-mismatched transplants. Independent variables that will be examined include donor-recipient KIR mismatch, taking into consideration the interactions with donor-recipient human leukocyte antigen (HLA) compatibility, and the numbers of CD34+ cells and CD3+ cells in the graft.|Up to 42 days after SCT|||||||
2795521|NCT00553202|Other Pre-specified|Acute and Chronic Graft-versus-host Disease|Acute and chronic GVHD will be summarized.|Up to 5 years|||||||
2795522|NCT00553202|Other Pre-specified|Disease-free Survival|The cumulative incidence of relapse or death after SCT will be calculated by considering relapse and death due to other causes as competing events.|From the date of SCT to the date of relapse, the date of death, or the date of last follow-up, whichever occurs first|||||||
2795523|NCT00553202|Primary|Cumulative Incidence of NK Cell Reconstitution|Cumulative incidence of successful reconstitution to donor level is calculated.|At 5 years from HSCT date|Patients without completion of planned therapy (n=68) or without NK cell status (n=38) are excluded from analyses of TExp|||Percentage of participants||95% Confidence Interval|Number
2795524|NCT00553202|Primary|Overall Survival (OS)|OS - Time from HSCT until death|At 5 years from HSCT date|Patients without completion of planned therapy (n=68) are excluded from analyses of OS|||Percentage of participants||95% Confidence Interval|Number
2795525|NCT00553163|Secondary|Perceived Stress Questionnaire-Recent (PSQ-R)|Measure of recent psychological stress. THE PSQ R consists of a 30 question questionnaires: recent, in which the statements used apply to the last month in which used statements apply to the last two years (Appendix 1.3). The score for both recent and general stress levels were stated as the PSQ index ranging from 0 (non-stressed) to 0.99 (highly stressed). Higher scores indicate worse outcome.|13 weeks|4 hypnotherapy and 1 control patient failed to complete their questionnaires|||units on a scale||Full Range|Median
2795526|NCT00553163|Secondary|Hospital Anxiety and Depression Score-Depression (HADSD)|Measure of depression. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 (minimum) to 21 (maximum) for anxiety and (minimum) to 21 (maximum) for depression. Higher scores worse outcome.|13 weeks|4 hypnotherapy and 1 control patient failed to complete their questionnaires|||units on a scale||Full Range|Median
2795527|NCT00553163|Secondary|Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13|Measure of anxiety, HADS Hospital anxiety and depression scale. HADS questionnaire consists of a 14 question validated questionnaire, developed to measure anxiety and depression in the hospital setting. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 (minimum) to 21 (maximum) for anxiety and 0 (minimum) to 21 (maximum) for depression. Higher scores indicate worse outcome,|13 weeks|4 hypnotherapy and 1 control patient failed to complete their questionnaires|||score on a scale||Full Range|Median
2795528|NCT00553163|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13|IBDQ (standard measure of IBD patients' Quality of life (QoL) (Irvine et al 1982 approx). The IBDQ is a validated and reliable tool to measure of health-related quality of life in adult patients with IBD. The questionnaire consists of 32 questions scored in four domains: bowel symptoms, emotional health, systemic systems and social function. Scores range from 1 (poorest QoL) to 7 (best QoL). Higher scores indicate better QoL. Lowest score 7, highest score 224.|13 weeks|Patients all assessed at 13 weeks (end of treatment phase). 4 hypnotherapy and 1 control patient failed to complete their questionnaires|||units on a scale||Full Range|Median
2795529|NCT00553163|Primary|Relapse at 1 Year|The number of patients suffering a relapse was compared between the two treatment groups, and was the primary outcome parameter of this study.|1 year||||Participants|||Count of Participants
2795530|NCT00553150|Secondary|Overall Survival Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 15 years||||months||95% Confidence Interval|Median
2795531|NCT00553150|Secondary|Progression-free-survival at 6 Months (Phase II)|Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|at 6 months||||proportion of participants||95% Confidence Interval|Number
2795532|NCT00553150|Secondary|Time to Progression (Phase II)|Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method. Progression is defined as at least a 25% increase in product of perpendicular diameters of contrast enhancement or mass or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|Up to 5 years||||months||95% Confidence Interval|Median
2795533|NCT00553150|Secondary|Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)|The response rate is defined as the percentage of patients receiving F-fluorothymidine positron emission tomography (FLT-PET) imaging whose cancer shrinks or disappears after treatment. A reduction in standardized uptake value (SUV) of 30% or greater in the T1-post-gadolinium scan volume of interest (T1-gad VOI) or the total tumor VOI will be considered a responsive tumor.|Up to 5 years|Of the 11 patients with measurable residual disease and pre-everolimus FLT-PET imaging, 2 did not have a second FLT-PET scan performed due to technical difficulties with FLT production, leaving 9 patients who could be assessed for changes in FLT uptake.|||percentage of participants||95% Confidence Interval|Number
2795534|NCT00553150|Primary|Overall Survival at 12 Months (Phase II)|"The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a success. Patients who die within 12 months after start of therapy will be considered to have failed."|at 12 months||||proportion of participants||95% Confidence Interval|Number
2795535|NCT00553150|Primary|Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)|Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: >= Grade 3 diarrhea or skin rash; >= Grade 4 neutropenia, leukopenia, or thrombocytopenia; >= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other >= 3 non-hematologic events; or >= Grade 4 radiation dermatitis. Maximum tolerated dose (MTD) was defined a priori as the highest dose level at which 0 or 1 of 6 patients developed DLTs. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|Up to 49 days|Eighteen patients were enrolled in Phase I of the study to determine the maximum tolerated dose (MTD). The dosage of RAD001 was escalated in cohorts of 6 patients.|||participants who developed DLTs|||Number
2795536|NCT00553098|Secondary|Number of Patients Diagnosed With Chronic GVHD|Number of patients diagnosed with chronic GVHD within 1 year post transplant|1 year|Excludes 6 patients who expired prior to Day 100|||Participants|||Count of Participants
2795537|NCT00553098|Secondary|Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD|Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant|Day 100|Excludes 10 patients who were not diagnosed with acute GVHD|||Participants|||Count of Participants
2795538|NCT00553098|Secondary|Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD|Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant|Day 100|Excludes 10 patients who were not diagnosed with acute GVHD|||Participants|||Count of Participants
2795539|NCT00553098|Secondary|Number of Patients Diagnosed With Acute GVHD|Number of patients diagnosed with acute GVHD by Day 100 post transplant|Day 100||||Participants|||Count of Participants
2795540|NCT00553098|Secondary|Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant|Number of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant.|100 days||||Participants|||Count of Participants
2795541|NCT00553098|Secondary|Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant|Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant|1 year|Excludes 9 patients who expired prior to 1 year time point|||Participants|||Count of Participants
2795542|NCT00553098|Secondary|Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant|Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant.|1 year|Excludes 9 patients who expired prior to 1 year time point|||Participants|||Count of Participants
2795543|NCT00553098|Secondary|Disease Response by 1 Year Post Transplant|Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence)|1 year|Excludes 9 patients who expired prior to 1 year time point.|||Participants|||Count of Participants
2795544|NCT00553098|Secondary|Immune Reconstitution by 1 Year Post Transplant|Number of patients with normal range CD3 at 1 year post transplant|1 year|Excludes 16 patients: 13 patients who did not achieve 1 year time point (9 expired, 4 went to second transplant) and 3 patients for whom no data was sent at 1 year from external site|||Participants|||Count of Participants
2795545|NCT00553098|Secondary|Overall Survival|Number of patients alive at 1 year|1 year|Excludes 3 patients with graft rejection and second transplant prior to 1 year.|||Participants|||Count of Participants
2795546|NCT00553098|Primary|Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism|The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism.|At 1 year post transplant|Excludes 9 patients who expired prior to 1 year|||Participants|||Count of Participants
2795547|NCT00552929|Secondary|Number of Participants With An Adverse Event (AE)|The number of participants who had at least one AE during treatment and follow-up was assessed. An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|From Screening to 7 post-operative days|All randomized participants who received at least one dose of study treatment and had follow-up.|||Participants|||Count of Participants
2795548|NCT00552929|Secondary|Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|Up to 102:25 (min:sec)|The analysis population consisted of all randomized participants who were given at least one administration of sugammadex and had at least one post-baseline efficacy measurement, without any major protocol violation.|||Minutes||Standard Deviation|Mean
2795560|NCT00552760|Primary|Pittsburgh Sleep Quality Index (PSQI) Global Score|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.|||units on scale||Standard Error|Mean
2795549|NCT00552929|Secondary|Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|Up to 96:24 (min:sec)|The analysis population consisted of all randomized and treated participants who had at least one post-baseline efficacy measurement, without any major protocol violation.|||Minutes||Standard Deviation|Mean
2795550|NCT00552929|Primary|Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|Up to 131:40 (min:sec)|The analysis population consisted of all randomized and treated participants who had at least one post-baseline efficacy measurement, without any major or multiple minor protocol violations.|||Minutes||Standard Deviation|Mean
2795551|NCT00552812|Secondary|Systolic Blood Pressure, Difference Between Upper and Lower Extremities|Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.|Baseline and 12 months|Comparison between baseline(n=105) and 12 month follow up (n=92)|||mmHg||Standard Deviation|Mean
2795552|NCT00552812|Secondary|Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement|Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure > 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).|Baseline and 12 months|Study patients compared at baseline and within the 12 month follow up window: Baseline (n=105) compared to 12 month follow up (n=92)|||percentage of participants|||Number
2795553|NCT00552812|Primary|Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months|Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)|12 months||||mmHg||Standard Deviation|Mean
2795554|NCT00552786|Secondary|Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had all 4 post-baseline assessments (measurements at beginning of 1st and 2nd intervention periods and end of 1st and 2nd intervention periods).|||decibels (dB SPL)||Standard Deviation|Mean
2795555|NCT00552786|Primary|Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had at least one post-baseline assessment.|||decibels||Standard Deviation|Mean
2795556|NCT00552760|Secondary|Cumulative Proportion of Participants in Each Arm Surviving Without Relapse|Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.|||Cumulative proportion of participants|||Number
2795557|NCT00552760|Secondary|Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score|3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures|||units on scale||Standard Error|Mean
2795558|NCT00552760|Secondary|Young Mania Rating Scale (YMRS) Total Score|11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures|||units on scale||Standard Error|Mean
2795559|NCT00552760|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures|||units on scale||Standard Error|Mean
2795565|NCT00552669|Primary|Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.|Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.|Follow up will be conducted by the coordinating Center at 18 months of follow up|All patients were analyzed for ITT and the imputation technique was LOCF|||US dollars||Standard Deviation|Mean
2795566|NCT00552617|Secondary|Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)|All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.|||Minutes||Standard Deviation|Mean
2795567|NCT00552617|Secondary|Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)|All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.|||Minutes||Standard Deviation|Mean
2795568|NCT00552617|Primary|Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)|All randomized participants who received sugammadex or placebo; without any protocol violations, and who had at least one post baseline efficacy measurement, who had a TOF trace, had a reliable TOF trace, and where drug administration did not interfere with the effect of rocuronium or vecuronium.|||Minutes||Standard Deviation|Mean
2795569|NCT00552578|Secondary|Treatment Retention.|"Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses)."|Six months|Analysis was intent-to-treat.|||Participants|||Number
2795570|NCT00552578|Secondary|Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.|Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.|Baseline and six months|"Reported value (number) was the number who reported a better overall quality-of-life to the question: How would you describe your overall level of function now as compared to the time right before you started the study? Responses were recorded as: better, no change, or worse."|||Participants|||Number
2795571|NCT00552578|Primary|Relapse to Substance Abuse|Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.|Six months||||participants|||Number
2795572|NCT00552513|Secondary|In-hospital Major Bleeding||Hospital discharge|||||||
2795573|NCT00552513|Secondary|Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180||180 days|||||||
2795574|NCT00552513|Secondary|Stroke at 30 Days and 180 Days||180 days|||||||
2795575|NCT00552513|Secondary|Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days||180 days||||Eparticipants|||Number
2795576|NCT00552513|Secondary|First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia||180 days||||participants|||Number
2795577|NCT00552513|Primary|Composite of Death, Myocardial (re-) Infarction, or Stroke||180 days|All patients were included in the final intention-to-treat analysis. Event rates in the two groups were estimated with the use of the Kaplan–Meier method. The hazard ratio and two-sided 95% confidence intervals were calculated with the use of a Cox proportional-hazards model.|||participants|||Number
2795578|NCT00552448|Secondary|Number of Participants With Chest Discomfort||During PICU admission||||participants|||Number
2795579|NCT00552448|Secondary|Pediatric Asthma Severity Score (Modified Pulmonary Index Score)|Modified Pulmonary Index Score (MPIS): a validated asthma severity score in pediatric population (Carroll CL et al. A modified pulmonary index score with predictive value for pediatric asthma exacerbations, Ann Allergy Asthma Immunol 2005) Consists of: 1) oxygen saturation on room air 2) accessory muscle use 3) inspiratory to expiratory ratio 4) degree of wheezing 5) heart rate 6) respiratory rate Scored observations 0, 1, 2 or 3. Total score range 0 - 18. Mild exacerbation total less than 6, moderate exacerbation 6 - 10, severe exacerbation higher than 10|Discharge from PICU|Participants with available data|||units on a scale||Full Range|Mean
2795580|NCT00552448|Secondary|Total Days of Hospital Admission|This is limited due to non collection by collaborating centers.|Days|Data not collected||||||
2795581|NCT00552448|Primary|Hours Spent in Pediatric ICU|Length of stay (hours) in Pediatric ICU.|Number of hours from admission to discharge from PICU||||Hours||Standard Deviation|Mean
2795582|NCT00552422|Primary|Symptomatic Improvement|The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.|2 months||||participants|||Number
2795583|NCT00552409|Primary|Change in Urine Albumin Excretion|Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.|Baseline, 3 months, and one year|All participants were analyzed|||percent difference||95% Confidence Interval|Mean
2795584|NCT00552396|Secondary|"Number of Evaluable Patients With Stable Disease. Evaluable is Defined as 2 Consecutive M Protein Assessments"|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease|From start of the treatment to end of study or disease progression||||Number of participants|||Number
2795585|NCT00552396|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Cycle 1.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration||||ng*hours/ml||Geometric Coefficient of Variation|Geometric Mean
2795586|NCT00552396|Secondary|Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration|Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2795587|NCT00552396|Primary|Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment|The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.|From start of the treatment to end of study|All treated participants who received at least one dose of the study drug and were evaluable for DLT|||Number of participants with DLT|||Number
2795588|NCT00552344|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||percentage of subjects|||Number
2795589|NCT00552344|Secondary|Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Week 52|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||μg/mL||95% Confidence Interval|Geometric Mean
2795590|NCT00552344|Secondary|Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)|IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.|||percentage of subjects||95% Confidence Interval|Number
2795591|NCT00552344|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.|||percentage of subjects||95% Confidence Interval|Number
2795592|NCT00552344|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||percentage of subjects|||Number
2795593|NCT00552344|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.|||percentage of subjects|||Number
2795594|NCT00552305|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.|||percentage of subjects|||Number
2795641|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients|||Participants|||Number
2795595|NCT00552305|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.~Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, End of Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.|||percentage change||Full Range|Median
2795596|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
2795597|NCT00552305|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
2795598|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
2795599|NCT00552279|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||After the third vaccine dose||||Participants|||Count of Participants
2795600|NCT00552279|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6~Number of pregnancies and pregnancy outcomes."|During the entire study period (up to Month 18 or Month 12)|Analysis was performed on the Total vaccinated cohort, on pregnant subjects|||Participants|||Count of Participants
2795601|NCT00552279|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.~NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.~An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the entire study period (up to Month 18 or up to Month 12)||||Participants|||Count of Participants
2795602|NCT00552279|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2795603|NCT00552279|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2795604|NCT00552279|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2795605|NCT00552279|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as GMT.|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity|||EL.U/mL||95% Confidence Interval|Geometric Mean
2795606|NCT00552279|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
2795607|NCT00552279|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as geometric mean titer (GMT).|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity|||EL.U/mL||95% Confidence Interval|Geometric Mean
2795608|NCT00552279|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity|||Participants|||Count of Participants
2795614|NCT00552240|Secondary|Number of Participants With Genotypic Resistance at the Time of Virologic Failure.|Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.|baseline to week 48|Includes only treated patients with data in the specified time window||||||
2795615|NCT00552240|Secondary|Percentage Adherence by Pill Count|Number of pills not returned / number of treatment days in percent (%)|baseline to week 48|All treated patients with data|||percentage adherence||Standard Deviation|Mean
2795616|NCT00552240|Secondary|Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48|using 4-variable Modification of Diet in Renal Disease (MDRD) formula|baseline to week 48|Includes only treated patients with data for the specified time window|||ml/min/1.73m^2||Standard Deviation|Mean
2795617|NCT00552240|Secondary|Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group||baseline to week 48|Not calculated as no data on family history of cardiovascular disease were available||||||
2795618|NCT00552240|Secondary|Change in Framingham Score|Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.|baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||percent 10-year risk||Standard Deviation|Mean
2795619|NCT00552240|Secondary|Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||ratio||Standard Deviation|Mean
2795620|NCT00552240|Secondary|Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||mg/dl||Standard Deviation|Mean
2795621|NCT00552240|Secondary|Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||mg/dl||Standard Deviation|Mean
2795622|NCT00552240|Secondary|Change in Fasting Plasma Triglycerides Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)|||mg/dl||Standard Deviation|Mean
2795623|NCT00552240|Secondary|Change in Fasting Plasma Total Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF).|||mg/dl||Standard Deviation|Mean
2795624|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 48.|Patients on-treatment, data within time windows|baseline to week 48|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795625|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 36.|Patients on-treatment, data within time windows|baseline to week 36|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795626|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 24.|Patients on-treatment, data within time windows|baseline to week 24|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795627|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 12.|Patients on-treatment, data within time windows|baseline to week 12|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795628|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 8.|Patients on-treatment, data within time windows|baseline to week 8|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795629|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 6.|Patients on-treatment, data within time windows|baseline to week 6|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795630|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 4.|Patients on-treatment, data within time windows|baseline to week 4|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795631|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 2.|Patients on-treatment, data within time windows|baseline to week 2|Includes only treated patients with data in the specified time window|||cells/mm^3||Standard Deviation|Mean
2795632|NCT00552240|Secondary|AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death|"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)."|baseline to week 48|All treated patients|||Participants|||Number
2795633|NCT00552240|Secondary|Number of Patients With Virologic Rebound to >400 Copies/ml|HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 48|All treated patients|||Participants|||Number
2795634|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients|||Participants|||Number
2795635|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients|||Participants|||Number
2795636|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients|||Participants|||Number
2795637|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients|||Participants|||Number
2795638|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients|||Participants|||Number
2795650|NCT00552240|Secondary|Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response|HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 24 and week 48|All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.|||Participants|||Number
2795651|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml||baseline to week 48|All responders|||days||Inter-Quartile Range|Median
2795652|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants|Time to response whereby patients withdrawing early were censored after their withdrawal|baseline to week 48|All treated patients|||days||Inter-Quartile Range|Median
2795653|NCT00552240|Secondary|Number of Participants With Virologic Success (FDA Definition)|HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).|baseline to week 48|All treated patients.|||Participants|||Number
2795654|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48|HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.|baseline to week 48|Only includes treated patients with data in the Week 48 time window.|||Participants|||Number
2795655|NCT00552240|Secondary|Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm|HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.|||Participants|||Number
2795656|NCT00552240|Primary|Number of Participants With Virologic Response (VR)|VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.|||participants|||Number
2795657|NCT00552188|Secondary|Change From Baseline in Plaque Imaging After 6 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.|Baseline and 6 Weeks|Evaluable Population|||TBR||95% Confidence Interval|Least Squares Mean
2795658|NCT00552188|Primary|Change From Baseline in Plaque Imaging After 24 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.|Baseline and 24 Weeks|Evaluable Population|||TBR||95% Confidence Interval|Least Squares Mean
2795659|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795660|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795661|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795662|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795663|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795664|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2797305|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2795665|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795666|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795667|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795668|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795669|NCT00552175|Secondary|Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795670|NCT00552175|Primary|Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.|||units on a scale||Standard Error|Least Squares Mean
2795671|NCT00552110|Primary|Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score|Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.|from baseline to hour 4 on Day 1|Intention to treat: all randomized subjects who had taken at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
2795672|NCT00552110|Primary|Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15|Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.|15 days of treatment|Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
2795673|NCT00552084|Primary|Documented Recurrence of Atrial Fibrillation/Atrial Flutter|Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.|Measured at Week 24 or exit||||percentage of participants|||Number
2795674|NCT00552071|Secondary|Serum IGF-1 Level|Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.|3 months|Subjects were regrouped for analysis by treatment. Serum IGF-I levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to Serum IGF-I levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.|||percentage of upper limit of normal||Standard Deviation|Mean
2795675|NCT00552071|Primary|Plasma Octreotide Level After Each Treatment Phase|Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.|3 months|Subjects were regrouped for analysis by treatment. Octreotide levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to octreotide levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.|||pg/mL||Standard Deviation|Mean
2795700|NCT00552032|Secondary|Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done|Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||Participants|||Number
2795676|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose|||percentage of subjects||95% Confidence Interval|Number
2795677|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795678|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795679|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795680|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795681|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795682|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 198 and 184 subjects respectively are included in this summary and have assessments at both Weeks 0 and 4. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
2795683|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 2|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
2795865|NCT00550537|Secondary|Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
2795684|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 4|The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795685|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 2|The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795686|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 4|The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795687|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 2|The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795688|NCT00552058|Secondary|Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6|The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
2795689|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||score on a scale||Standard Deviation|Mean
2795690|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795691|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 6|The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2795692|NCT00552058|Primary|Percentage of Subjects in Clinical Remission at Week 6|The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.|||percentage of subjects||95% Confidence Interval|Number
2799791|NCT00526591|Other Pre-specified|Effect of Treatment on Biological and Molecular Markers|Immunohistochemical Staining of Cellular and Molecular Markers in Prostate Tumor Tissue|After 8 weeks of therapy|||||||
2795693|NCT00552032|Secondary|Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score|"18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).~Grading was as follows:~Scores < 60 suggest a slight impact on health related quality of life (HRQL)~Scores 60-80 suggest a moderate impact~Scores over 80 suggest a great impact"|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 subjects were included in the ITT population. The ITT population included all randomized participants who received >=1 dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.~1 participant in Placebo group did not answer this questionnaire at baseline."|||Score on a scale||Standard Deviation|Mean
2795694|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS & 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.|||Score on a scale||Standard Deviation|Mean
2795695|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS & 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.|||Score on a scale||Standard Deviation|Mean
2795696|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS & 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.|||Score on a scale||Standard Deviation|Mean
2795697|NCT00552032|Secondary|Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe|PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT population. The ITT~population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."|||Participants|||Number
2795698|NCT00552032|Secondary|Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa|Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3||Standard Deviation|Mean
2795699|NCT00552032|Secondary|Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa|"Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.~Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) & were reported in cm^3."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3||Standard Deviation|Mean
2795726|NCT00551642|Primary|Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress|The primary outcome was determined by assessment of survival and incidence of BPD,which was defined by the need for supplemental oxygen at 36 weeks gestational age (GA); an infant who was alive without BPD at 36 weeks GA was counted as success; an infant who died or had BPD at 36 weeks GA was counted as a failure.|36 weeks gestational age||||participants alive without BPD|||Number
2795701|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3/sec||Standard Deviation|Mean
2795702|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||cm^3/sec||Standard Deviation|Mean
2795703|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).|||Pa/cm^3/sec||Standard Deviation|Mean
2795704|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants aged 7-11 years old (MFSN=19, Placebo=20).|||Pa/cm^3/sec||Standard Deviation|Mean
2795705|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction|Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
2795706|NCT00552032|Secondary|Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic|Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
2795707|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation|Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
2795708|NCT00552032|Secondary|Number of Participants With Otoscopic Results of: Normal or Abnormal|Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Participants|||Number
2795709|NCT00552032|Secondary|Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done|Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT~population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."|||Participants|||Number
2795781|NCT00551135|Secondary|Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)||Day 1|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.|||hours||Standard Error|Least Squares Mean
2795710|NCT00552032|Secondary|Total Frequency Symptom Scores: AM & PM|Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Score on a scale||Standard Deviation|Mean
2795711|NCT00552032|Secondary|Total Severity Symptom Scores: Morning and Evening (AM & PM)|Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.|||Score on a scale||Standard Deviation|Mean
2795712|NCT00552032|Primary|Change From Baseline in Adenoid/Choana (A/C) Index Grade|Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.|Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)|A total of 132 participants were included in the intent-to-treat (ITT) population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data are summarized in terms of the number of participants providing data at the relevant time point.|||Score on a Scale||Standard Deviation|Mean
2795713|NCT00551759|Primary|Proportion of Patients With Pathologic Complete Response|After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.|At time of surgery (which occurred 63 to 91 days after study entry)|Eligible and treated patients|||Proportion of patients||90% Confidence Interval|Number
2795714|NCT00551746|Secondary|The Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.||90-days|||||||
2795715|NCT00551746|Secondary|Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.|The platelet inhibitory pathway in which PGJ functions by performing platelet aggregation tests using agonists for the 4 major platelet activation pathways: ADP,thrombin receptor-activator peptide (TRAP), phorbol 12-myristate 13-acetate (PMA), arachadonic acid(10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days|||||||
2795716|NCT00551746|Primary|Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo|Platelet aggregation was measured using the agonist ADP (10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days|The number of participants evaluated were those who had both a baseline and visit 4 platelet aggregation and platelet-dependant inflammatory marker values|||percent||Standard Deviation|Mean
2795717|NCT00551707|Secondary|To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to 98 Days|||||||
2795718|NCT00551707|Primary|Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|Day 98|As treated population|||mg/L||Full Range|Median
2795719|NCT00551707|Secondary|To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98|||||||
2795720|NCT00551707|Secondary|Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98|As treated population|||percentage of change from baseline||Full Range|Median
2795721|NCT00551642|Secondary|Methemoglobin Level||Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment|||||||
2795722|NCT00551642|Secondary|Adverse Events||Study Duration|||||||
2795723|NCT00551642|Secondary|Arterial Oxygen Saturation by Pulse Oximetry||Study Duration|||||||
2795724|NCT00551642|Secondary|Vital Signs||Study Duration|||||||
2795725|NCT00551642|Primary|Survival||36 Weeks GA|||||||
2795727|NCT00551525|Secondary|Freedom From Progression (FFP) Rate at 2 Years|"Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See Limitations and Caveats section."|From randomization to 2 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2795728|NCT00551525|Secondary|Acute and Late Radiotherapy-Related Adverse Events|The number of patients who experienced a grade 1-5 radiation-related adverse events within 90 days of the start of radiotherapy (acute) and after 90 days (late). Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. Multivariate logistic regression was used to model the association of clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age with the occurrence of any acute radiotherapy-related adverse event. Odds ratios and the respective 95% confidence intervals were computed for each factor. Per the protocol, late adverse events were not analyzed.|90 days from start of radiotherapy|Eligible patients with adverse event data|||participants|||Number
2795729|NCT00551525|Secondary|Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)|"Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:~HEMATOLOGIC Platelet grade 3-5 White blood cell count (WBC) grade 3-5 Hemoglobin grade 3-5 Any secondary leukemia's~HEMORRHAGE/BLEEDING Hemorrhage, gastrointestinal - anus, rectum grade 3-5 Hemorrhage, genitourinary - bladder, prostate, urethra grade 3-5~SAMARIUM 153-RELATED GRADE 5 ADVERSE EVENT PRIOR TO TREATMENT OF RADIATION."|Twelve weeks from the date of Samarium 153 infusion|Eligible patients with adverse event data|||percentage of participants|||Number
2795730|NCT00551525|Secondary|Number of Patients With Hematologic Toxicity at 12 Weeks|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's.|Twelve weeks from the date of Samarium 153 infusion.|Eligible patients who started study treatment|||Participants|||Count of Participants
2795731|NCT00551525|Secondary|Completion of Therapy|The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint.|90 days from the end of radiation therapy.|All eligible patients who started treatment and did not withdraw consent prior to 90 days from the end of radiation therapy|||percentage of participants||95% Confidence Interval|Number
2795732|NCT00551525|Primary|Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration|A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming's Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.|Twelve weeks from the date of Samarium 153 infusion.|All eligible patients who received Samarium 153 with at least 12 weeks follow-up from the injection|||percentage of participants|||Number
2795733|NCT00551460|Secondary|Frequency of Toxicities|Adverse events that were possibly, probably or definitely related to study drug are reported.|Up to 3 years|The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.|||Participants|||Number
2795734|NCT00551460|Primary|Mortality Rate at 6 Weeks||6 weeks|The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.|||percentage of participants||95% Confidence Interval|Number
2795735|NCT00551460|Primary|Continuous Complete Remission at 3 Years|Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.|3 years|The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.|||percentage of participants||95% Confidence Interval|Number
2795736|NCT00551421|Secondary|Overall Survival|The duration of time from start of study treatment to death from any cause.|The duration of time from start of study treatment to death from any cause.||||months||95% Confidence Interval|Median
2795737|NCT00551421|Secondary|Progression-free Survival|The duration of time from start of study treatment to time of objective disease progression or death.|The duration of time from start of study treatment to time of objective disease progression or death.||||months||95% Confidence Interval|Median
2795738|NCT00551421|Primary|Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)|Objective tumor response rate defined as the proportion of patients with a best overall response of CR or PR, per RECIST criteria (Phase II).|Best tumor response from time period of start of study treatment to study discontinuation.||||percentage of patients|||Number
2795739|NCT00551421|Primary|Recommended Phase II Dose of Pertuzumab When Administered in Combination With Cetuximab (Phase I)|The regimen was deemed intolerable so there was no recommended phase II dose.|28 days|||||||Number
2800034|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
2795740|NCT00551369|Secondary|Assessment of Predictive Value of Blood Markers for Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2|Assess if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2 year primary tumor control and predict for grade ≥ 2 treatment-related adverse events. Unfortunately, there were not enough specimens submitted to perform this analysis. The specimens that were collected remain in the NRG Oncology Biobank and are available to be combined with other specimens from other studies for an appropriately powered project.|From start of treatment to 2 years.|The data required for this analysis was not obtained and will not be obtained.||||||
2795741|NCT00551369|Secondary|Level of Comorbidity Burden on Morbidity and Efficacy||From start of treatment to end of follow-up.|The data required for this analysis was not obtained and will not be obtained.||||||
2795742|NCT00551369|Secondary|Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years|PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.|From start of treatment to 2 years.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2795743|NCT00551369|Secondary|Other Grade 3-5 Adverse Events|The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2795744|NCT00551369|Secondary|Rate of Treatment-related Grade 3 or 4 Toxicity|The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2795745|NCT00551369|Primary|Primary Tumor Control at 2 Years|Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.|From start of treatment to 2 years.|All eligible patients who started study treatment|||percentage of patients||95% Confidence Interval|Number
2795746|NCT00551291|Secondary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to approximately 2 years||||percentage of participants|||Number
2795747|NCT00551291|Primary|Mean Number of Blood Transfusions Per Visit||Up to approximately 2 years||||transfusions/visit||Standard Deviation|Mean
2795748|NCT00551291|Primary|Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement|International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.|Up to approximately 2 years||||percentage of participants|||Number
2795749|NCT00551213|Secondary|Change From Baseline in Tumor Growth Rate|Tumor growth rate was assessed by CT or MRI scans using RECIST criteria at Screening, at every 8 weeks of robatumumab treatment and at post study. For Pre Baseline 1, tumor growth rate=(sum of longest diameter of target lesions at Baseline - the most recent prior to Baseline)/duration between Baseline and Pre Baseline. For all other cycles, tumor growth rate=(sum of longest diameter of target lesions at a cycle - Baseline)/ duration between Baseline and the cycle. The cycles presented below are relative to the first dose of robatumumab in Period 1.|Baseline and up to approximately 22 weeks|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.|||mm/day||Standard Deviation|Mean
2795814|NCT00550862|Primary|Alkaline Phosphatase (ALP).|The primary efficacy endpoint was the relative (%) change in plasma ALP from pretreatment values. The prestudy consensus opinion of the investigators was that a placebo-substracted ALP fall of ≥ 10% would be clinically significant.|Baseline and 12 weeks||||Percent (%) change||Standard Deviation|Mean
2795750|NCT00551213|Secondary|Best Overall Tumor Response Per Central Review|Tumor response was assessed by CT or MRI scan using RECIST v1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the LD for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.|||Participants|||Number
2795751|NCT00551213|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to last dose of study drug (Up to approximately 18 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.|||Participants|||Number
2795752|NCT00551213|Secondary|Best Overall Tumor Response Per Investigator Review|Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST v 1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.|||Participants|||Number
2795753|NCT00551213|Secondary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.|||Participants|||Number
2795754|NCT00551213|Primary|Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion|FDG-PET was used in this study to detect the biological activity of modulation of the target within the tumor. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 was used to select the target lesion. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were identified as target lesions and recorded and measured at Baseline. The changes in SUVmax were calculated using the formula: (endpoint SUVmax - baseline SUVmax)/baseline SUVmax as a percentage. If multiple lesions had been measured at a visit, percentages calculated for all target lesions were averaged to find the decrease during the treatment period per participant. FDG SUVmax responder was defined as participants with >20% decrease in SUVmax after the first cycle of robatumumab in Period 2.|After the first robatumumab dose in Period 2 (Up to approximately 4 weeks after first robatumumab dose in Period 1)|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 and had SUV data before and after the first dose of robatumumab in Period 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.|||Participants|||Number
2795755|NCT00551200|Primary|Number of Subjects Experienced Serious Adverse Events||during the period subjects on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)||||participants|||Number
2795756|NCT00551200|Primary|Number of Subjects Experienced Adverse Events||during the period on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)||||participants|||Number
2795757|NCT00551200|Secondary|Drug Preference for HPN-100 or Buphenyl® (as Assessed by Global Preference Question)||End of Study||||participants|||Number
2795758|NCT00551200|Primary|Venous Ammonia Levels at the Peak and Mean TNUAC Time-normalized Area Under the Curve)|Data were collected at pre-first dose and at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone), and at steady state (1 week) after each dose escalation||||μmol/L|concentration of ammonia|Standard Deviation|Mean
2795759|NCT00551200|Secondary|Pharmacokinetics (Plasma and Urine PK Parameters of Study Drugs and Their Metabolites)|measured AUC0-24 (Area under the curve from time 0 (pre-dose) to 24 hours) for each metabolite in plasma. Data were collected at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post-first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone)||||μg*h/mL|plasma|Standard Deviation|Mean
2795760|NCT00551174|Secondary|Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months|Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6 months|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93.|||Percent change||Standard Deviation|Mean
2795782|NCT00551135|Secondary|Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)|PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.|Day 1|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.|||hours||Standard Error|Least Squares Mean
2795761|NCT00551174|Secondary|Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months|Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76.|||Percent change||Standard Deviation|Mean
2795762|NCT00551174|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months|Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314.|||Percent change||Standard Deviation|Mean
2795763|NCT00551174|Primary|Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months|Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314.|||Percent change||Standard Deviation|Mean
2795764|NCT00551161|Primary|Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor|Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 - t1) - (t1 - t0)].|Baseline, 24 weeks, and 48 weeks|Per protocol|||ratio (normalized to T2-corrected water||Standard Deviation|Mean
2795765|NCT00551135|Secondary|Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)|NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.|||scores on a scale||Standard Deviation|Mean
2795766|NCT00551135|Secondary|Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf)|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.|||scores on a scale||Standard Deviation|Mean
2795767|NCT00551135|Secondary|Participants With Chronic Postoperative Pain|"Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?)"|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||participants|||Number
2795768|NCT00551135|Secondary|Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)|PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.|||scores on a scale||Standard Error|Least Squares Mean
2795769|NCT00551135|Secondary|Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.|Baseline and Days 1 and 7 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.|||scores on a scale||Standard Error|Least Squares Mean
2795770|NCT00551135|Secondary|Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.|3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
2795771|NCT00551135|Secondary|Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.|||scores on scales||Standard Error|Least Squares Mean
2795772|NCT00551135|Secondary|Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score|Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
2795773|NCT00551135|Secondary|Participants With Physician Contacts Post-discharge|"Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"|24 and 72 hours (h) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations|||participants|||Number
2795774|NCT00551135|Secondary|Participants With Wound Healing Complications|Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.|Day 7 post surgery (PS) and up to 30 days PS|Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.|||participants|||Number
2795775|NCT00551135|Secondary|Subject Global Evaluation of Study Medication (GESM)|GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.|24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations|||participants|||Number
2795776|NCT00551135|Secondary|Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).|3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.|||participants|||Number
2795777|NCT00551135|Secondary|Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]).|3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
2795778|NCT00551135|Secondary|Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study|Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.|End of Surgery through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.|||mg||Standard Error|Least Squares Mean
2795779|NCT00551135|Secondary|Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery|Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.|24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). During surgery data not analyzed as planned.|||mg||Standard Error|Least Squares Mean
2795780|NCT00551135|Secondary|Daily Sleep Interference Rating Scale (DSIRS) Score|DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.|Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on a scale||Standard Error|Least Squares Mean
2795783|NCT00551135|Secondary|Time From End of Surgery to First Rescue Medication|Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.|Day 1 through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.|||hours||Standard Error|Least Squares Mean
2795784|NCT00551135|Secondary|Numeric Rating Scale (NRS): Average Pain|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
2795785|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)|NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|1 through 48 hours post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations.|||score on scale||Standard Error|Least Squares Mean
2795786|NCT00551135|Secondary|Numerical Rating Scale (NRS): Current Pain at Rest|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
2795787|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing|NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).|1 hour through 48 hours post surgery|MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
2795788|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Coughing|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
2795789|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Walking|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
2795790|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Sitting|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).|||scores on scale||Standard Error|Least Squares Mean
2795791|NCT00551135|Primary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).|24 hours post surgery|Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.|||scores on scale||Standard Error|Least Squares Mean
2795792|NCT00551070|Secondary|Overall Survival||Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
2795793|NCT00551070|Primary|Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available|||ng/mL||Inter-Quartile Range|Median
2795794|NCT00551070|Primary|Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with all pharmacokinetic time points available|||ng x hr/mL||Inter-Quartile Range|Median
2795795|NCT00551070|Primary|Adverse Events (Grade 3 or Higher) During First Cycle of Treatment||Cycle 1|Eligible and treated patients.|||percentage of patients||95% Confidence Interval|Number
2795796|NCT00551070|Secondary|Number of Courses Received||Every cycle|Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.|||courses||Inter-Quartile Range|Median
2795797|NCT00551070|Secondary|Progression-free Survival||Every other cycle|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2795798|NCT00551070|Primary|Tumor Response|Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0|Every other cycle|Eligible and treated patients|||percentage of patients||90% Confidence Interval|Number
2795799|NCT00551031|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.~Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills"|Days 0 through 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.|||Participants|||Number
2795800|NCT00551031|Primary|Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.|||Percentage of Participants|||Number
2795801|NCT00551031|Primary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine|Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.|||Percentage of Participants|||Number
2795802|NCT00551031|Primary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post vaccination|Serum antibody titers GMTs were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2795803|NCT00550953|Secondary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or T40 during the double-blind treatment period.|||participants|||Number
2795804|NCT00550953|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
2795805|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
2795806|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
2795807|NCT00550953|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
2795808|NCT00550953|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||percentage of participants|||Number
2795809|NCT00550953|Secondary|Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
2795810|NCT00550953|Primary|Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.|||mmHg||Standard Error|Mean
2795811|NCT00550862|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 Weeks|||||||
2795812|NCT00550862|Secondary|Alanine Aminotransferase (ALT)|Mean percent change in serum alanine aminotransferase (ALT) from baseline to Day 85/early termination.|Baseline and 12 weeks||||Percent (%) change||Standard Deviation|Mean
2795815|NCT00550836|Secondary|Frequency and Severity of Observed Adverse Effects|"Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported.~A complete listing of all adverse events is reported in the Adverse Events section."|Up to 2 years|All evaluable patients were included in this analysis.|||participants|||Number
2795816|NCT00550836|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 2 years|All eligible treated patients were included in this analysis.|||months||95% Confidence Interval|Median
2795817|NCT00550836|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test.|Up to 2 years|All treated patients were included in this analysis.|||months||95% Confidence Interval|Median
2795818|NCT00550836|Secondary|Confirmed Response Rate|Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|Up to 2 years|All patients that started protocol treatment and were evaluated were included in this analysis.|||rate of confirmed response||95% Confidence Interval|Number
2795819|NCT00550836|Primary|Overall Survival|Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.|Up to 2 years|All treated patients that were eligible were included in the analysis.|||months||95% Confidence Interval|Median
2795820|NCT00550771|Secondary|Number of Participants Who Survived Without Relapse|"Relapse-free survival would have been determined by Kaplan-Meier method.~This was not calculated, since the 2 year follow-up was curtailed."|Approximately 2 years|||||||
2795821|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During 1 year of trastuzumab therapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.|||Participants|||Number
2795822|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During the 8 courses of chemotherapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.|||Participants|||Number
2795823|NCT00550771|Primary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment|"ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.~Each participant could not contribute more than 1 event."|||Participants|||Number
2795824|NCT00550745|Secondary|Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination|"Only Serious Adverse Events were collected and analyzed for this study.~A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|6 months|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 182 day reporting period. The date of death may have occurred after 182 days."|||Participants|||Number
2795851|NCT00550589|Secondary|Identification of Abnormally Methylated Genes in Perianal Dysplasia|Identification of abnormally methylated genes in perianal dysplasia|Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The lab analysis of genes was not performed||||||
2795825|NCT00550745|Primary|Serious Adverse Events Reported Within 42 Days Postvaccination|"Only Serious Adverse Events were collected and analyzed for this~study.~A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|42 Days|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days."|||Participants|||Number
2795826|NCT00550732|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 12 months|All enrolled participants who received at least one dose of study medication.|||Number of participants|||Number
2795827|NCT00550732|Secondary|Number of Participants With Response to Posaconazole in Combination Therapy|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The proportion of participants with response to posaconzole who received a prior combination antifungal regimen is not reported as per recommendation from the Safety and Steering Committee since only 1 participant was evaluable for this outcome measure.||||||
2795828|NCT00550732|Secondary|Overall Survival at 3 Months|Total number of participant survivors was assessed at 3 months.|3 months|All enrolled participants|||Percentage of Participants|||Number
2795829|NCT00550732|Secondary|Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug|Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.|Up to 6 months|The Efficacy Population included those participants with a visit 6 months after the last dose.|||Percentage of participants|||Number
2795830|NCT00550732|Secondary|Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 26 weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.|||Percentage of Participants|||Number
2795831|NCT00550732|Secondary|Percentage of Participants With a CR or PR by 12 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 12 Weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.|||Percentage of participants|||Number
2795832|NCT00550732|Secondary|Number of Participants With ≥50% Decrease in Lesion Size or Number|Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.|Up to 6 months|This outcome measure was not reported as the Safety and Steering Committee (SSC) no longer considered it relevant based on revised Mycoses Study Group and European Organization for Research and Treatment of Cancer (MSG/EORTC) Consensus Criteria.||||||
2795833|NCT00550732|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.|||Percentage of participants|||Number
2795834|NCT00550680|Secondary|Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion|The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|All Enrolled Population: Includes all participants enrolled into the study regardless of treatment received.|||participants|||Number
2795835|NCT00550680|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; number (n) of participants who entered each treatment period was reported.|||percentage of participants|||Number
2795836|NCT00550680|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population|||days||Standard Deviation|Mean
2795852|NCT00550589|Secondary|Identification of HPV-DNA Types Present in the Anus|Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline|Baseline|Number of patients with anal swabs or cytobrush results at baseline|||participants|||Number
2800035|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
2795837|NCT00550680|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
2795838|NCT00550680|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment.|||g/dL||Standard Deviation|Mean
2795839|NCT00550680|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment, and who fulfilled inclusion/exclusion criteria per study protocol.|||percentage of participants||95% Confidence Interval|Number
2795840|NCT00550654|Secondary|Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy|Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.|Baseline and prior to termination of systemic therapy or protocol withdrawal|No data/specimens were collected. Study was terminated due to poor accrual.||||||
2795841|NCT00550654|Secondary|Pain at Sites of Metastases|Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.|One and three months of follow up|No data/specimens were collected. Study was terminated due to poor accrual.||||||
2795842|NCT00550654|Secondary|Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis|Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.|One to three months of followup|No data/specimens were collected. Study was terminated due to poor accrual.||||||
2795843|NCT00550654|Secondary|12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.|12 months|No data/specimens were collected. Study was terminated due to poor accrual.||||||
2795844|NCT00550654|Secondary|Median Time to Local Progression|Interval from initiation of treatment on protocol to symptomatic or radiographic progression.|6-12 months|No data/specimens were collected. Study was terminated due to poor accrual.||||||
2795845|NCT00550654|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|9 months, 11 days||||Participants|||Number
2795846|NCT00550654|Primary|6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.|6 months|No data/specimens were collected. Study was terminated due to poor accrual.||||||
2795847|NCT00550615|Secondary|Number of Participants With Clinical Response Rates|"The Objective response rate (CR+PR) and the Clinical Benefit Rate (CR+PR+SD) were calculated according to revised response criteria for malignant lymphoma (Cheson) CR - Complete response is defined as: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.~PR - Partial response is defined as: ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.~SD - Stable Disease is define as: Failing to attain the criteria needed for a PR, but not fulfilling those for progressive disease."|after 2-28 day cycles of therapy|Of the 38 participants consented only 24 for were evaluable. See the participant flow section.|||Participants|||Count of Participants
2795848|NCT00550615|Primary|Maximum Tolerated Dose||after 1-28 day cycle of therapy|Two subjects enrolled in Phase 1 of the study were never treated and not included in the analysis.|||milligrams PO daily|||Number
2795849|NCT00550589|Secondary|Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene expression analysis was not done||||||
2795850|NCT00550589|Secondary|Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene analysis was not done||||||
2795853|NCT00550589|Secondary|Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA|Number of patients who cleared HPV among those who had a complete or partial response|6 weeks after treatment discontinuation|Participants who had a partial or complete response and for whom pre and post-treatment HPV data were available|||participants|||Number
2795854|NCT00550589|Secondary|Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue|Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue|Baseline|Number of patients with tissue samples available at baseline|||participants|||Number
2795855|NCT00550589|Primary|Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0|Number of study patients who had a serious adverse event|Every 2 weeks on study, 6 weeks after treatment discontinuation|All enrolled patients|||participants|||Number
2795856|NCT00550589|Primary|Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)||6 weeks after treatment discontinuation||||proportion of participants|||Number
2795857|NCT00550550|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS|The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry for the rhinoconjunctivitis quality-of-life measure.|||Units on a Scale||Standard Error|Mean
2795858|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
2795859|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst).|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
2795860|NCT00550550|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.|From the Start of the GPS to the End of the GPS|The Full Analysis Set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.|||Units on a Scale||Standard Error|Mean
2795861|NCT00550537|Secondary|Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method.|Through study completion, an average of 1 year|Total 116 participants. One patient was excluded due to death before any treatment.|||months||95% Confidence Interval|Median
2795862|NCT00550537|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|"The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B).~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Through study completion, an average of 1 year|116 paticipants, one patient was excluded due to death before any treatment. All patients who received erlotinib treatment and experienced an Adverse events.|||participants|||Number
2795863|NCT00550537|Secondary|Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method.|Through study completion, an average of 1 year|Total 116 participants. One patient was excluded due to death before erlotinib treatment. Total 115 patients were included in the analysis.|||months||95% Confidence Interval|Median
2795864|NCT00550537|Secondary|Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response.|Through study completion, an average of 1 year|Total 116 participants, 11 not assessed and 4 not evaluable. 101 assessed for response.|||percentage of patients assessed||95% Confidence Interval|Mean
2795867|NCT00550537|Secondary|Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment|End of treatment date|End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
2795868|NCT00550537|Secondary|Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
2795869|NCT00550537|Secondary|Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
2795870|NCT00550537|Primary|Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease||End of treatment date|Lab data was lost by the collaborating institution, Colorado.||||||
2795871|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia|Incidence of potentially clinically significant ECG abnormalities: arrhythmia|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795872|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)|Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795873|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave|Incidence of potentially clinically significant ECG abnormalities: T wave|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795874|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment|Incidence of potentially clinically significant ECG abnormalities: ST Segment|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795875|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795876|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795877|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval|Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795878|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)|Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795879|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium|Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2 mEq/L)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795880|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose|Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795881|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol|Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795882|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid|Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795883|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)|Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795884|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Neutrophils|Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795885|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes|Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795886|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)|Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795887|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin|Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2800036|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
2795888|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Temperature|Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795889|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Weight|Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795890|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Pulse Rate|Incidence of abnormal pulse rate post-baseline [abnormal values: >=120 beats per minute (bpm) + increase of >=15 bpm; <=50 bpm + decrease of >=15 bpm]|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795891|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Blood Pressure|Incidence of abnormal systolic & diastolic blood pressure values post-baseline (abnormal systolic values: >=180 mmHg + increase of >=20 mmHg, <= 90 mmHg + decrease >=20 mmHg; abnormal diastolic values: >=105 mmHg+increase of >=15 mmHg, <=50 mmHg + decrease of >= 15 mmHg)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication|||participants|||Number
2795892|NCT00550459|Secondary|Change From Baseline in Serum Sodium; ITT Population|Change from Baseline to Day 22 in Serum Sodium; ITT population|Baseline and Day 22|ITT population with OC|||mEq/L||Standard Deviation|Mean
2795893|NCT00550459|Secondary|Change From Baseline in Postural Stability Test|Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population|baseline and Day 22|ITT population with LOCF (this group includes missing values)|||Z-score||Standard Deviation|Mean
2795894|NCT00550459|Secondary|Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)|Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population|baseline and Day 22|ITT population with OC|||Seconds||Standard Deviation|Mean
2795895|NCT00550459|Secondary|Change From Baseline in Overall Neurocognitive Composite Score|Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
2795896|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
2795897|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
2795898|NCT00550459|Secondary|Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests|Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population|baseline and Day 22|ITT population with OC|||Z-score||Standard Deviation|Mean
2795899|NCT00550459|Primary|Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)|"Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize yes 50 times;Choice=recognize yes or no 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right & left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data"|baseline and Day 22|Analysis based upon observed cases (OC).|||Z-score||Standard Deviation|Mean
2795900|NCT00550446|Other Pre-specified|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795975|NCT00550394|Primary|Drinks Per Drinking Day|Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)|baseline to 12 weeks or endpoint (up to 11 weeks)||||Drinks per drinking day||Standard Deviation|Mean
2795901|NCT00550446|Other Pre-specified|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795902|NCT00550446|Other Pre-specified|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795903|NCT00550446|Other Pre-specified|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795904|NCT00550446|Other Pre-specified|Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24|The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
2795905|NCT00550446|Other Pre-specified|Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers|The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||cells per micro liter (cells/mcL)||Standard Deviation|Mean
2795906|NCT00550446|Other Pre-specified|Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Standard Deviation|Mean
2795907|NCT00550446|Other Pre-specified|Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels|Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2795908|NCT00550446|Secondary|Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795976|NCT00550394|Primary|Drinks Per Day|Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)||||Drinks per day||Standard Deviation|Mean
2795909|NCT00550446|Secondary|Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795910|NCT00550446|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795911|NCT00550446|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795912|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2795913|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)|CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2795914|NCT00550446|Secondary|Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)|Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2795915|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795916|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2796011|NCT00549939|Secondary|Absolute Change in Detrusor LPP|Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline|12 weeks ((double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).|||cmH2O||Standard Error|Least Squares Mean
2795917|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795918|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795919|NCT00550446|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795920|NCT00550446|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2795921|NCT00550446|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
2795922|NCT00550446|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
2795923|NCT00550446|Secondary|Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2795924|NCT00550446|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2795925|NCT00550446|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2795926|NCT00550446|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2795927|NCT00550446|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2795928|NCT00550446|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
2795929|NCT00550446|Secondary|Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
2795930|NCT00550446|Secondary|Swollen Joint Counts (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Deviation|Mean
2795931|NCT00550446|Secondary|Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
2795932|NCT00550446|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Deviation|Mean
2795933|NCT00550446|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 10, 12|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. Missing values were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2795934|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.|||percentage of participants|||Number
2795935|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.|||percentage of participants|||Number
2801831|NCT00513695|Secondary|Relapse Rate|Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.|Up to two years||||probability of relapse||95% Confidence Interval|Number
2795936|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2795937|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: 20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2795938|NCT00550446|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 % improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. The analysis used Baseline Observation Carried Forward (BOCF) imputation for missing values.|||percentage of participants|||Number
2795939|NCT00550420|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|HbA1c was evaluated as safety parameter in this study. The values of change from Baseline was presented. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was measured as the BW at specified visit minus the Baseline value.|Baseline (Vsit 1 W0), W12, W24, W36, W52, W76 and Follow-up (W82)|All subject population. Only those participants available at the indicated time points were analyzed.|||Percent HbA1c||Standard Deviation|Mean
2795940|NCT00550420|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE 4 Status at W24 and W52|"The NPI assessed behavioural disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The participant caregiver asked about behaviour in the participant. If Yes, the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score was calculated by adding all domain scores together: NPI total score (from 0-144) and NPI distress score (from 0-60), with higher scores indicating more severe behavioral disturbance. Baseline was referred to Visit 1 (W0) assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value."|Baseline (Visit 1, W0), W24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Score on scale||Standard Deviation|Mean
2795941|NCT00550420|Secondary|Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOEe 4 Status|The DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. The DAD was conducted as an interview with the caregiver and took approximately 20 minutes. Baseline was referred to Visit 1 (W0) assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2795942|NCT00550420|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE 4 Status at W24 and W52|The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale was completed by the investigator, based on the performance of the participant, and took approximately 5 to 10 minutes to administer. Change from parent Baseline in MMSE was analyzed using a mixed model for repeated measures (MMRM). Baseline was referred to Visit 1 (W0)assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W 24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2795962|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
2795943|NCT00550420|Secondary|Mean Clinician Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Score as a Function of APOE 4 Status|The CIBIC+ score used for global functioning assessment. The CIBIC+ assessment comprised of a 7-point rating of severity. It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; The lower score indicated betterment in functioning and higher score means greater dysfunction. The scale was based on interviews with the participant and the caregiver and was completed by an independent rater.|Baseline (Visit 1, W0), W 24 and W 52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2795944|NCT00550420|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score as a Function of Apolipoprotein E (APOE) 4 Status at W24 and W52|The 11-item ADAS-cog was used to assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline was referred to Visit 1 (W0)assessments. Change from Baseline was calculated as value at scheduled time point minus Baseline value.|Baseline (Visit 1, W0), W24 and W52|All subject population. All subject population was further stratified to 4 different cohorts based upon APOE 4 status as APOE 4 negative, APOE 4 positive, APOE 4 heterozygus and APOE 4 homozygus. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
2795945|NCT00550420|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern|The clinical chemistry parameters including alanine amino transferase (ALT), aldolase, aspartate amino transferase (AST), blood urea nitrogen /creatinine (BUN/Creat) ratio, cholesterol (Chol), creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase (GGT), glucose, high density lipid (HDL), low density lipid (LDL), potassium, troponin 1, and urea were assessed as safety parameters. The number of participants with values outside the reference range (potential clinical concern ) at any time on treatment (ATOT) and follow-up period were reported. The treatment period was till W104 followed by 6 weeks of follow-up period till W110 of study.|Up to 82 weeks|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2795946|NCT00550420|Secondary|Number of Participants With Hematological Parameters of Potential Clinical Concern|The hematological parameters including eosinophils, lymphocytes, monocytes, platelet count, Segmented Neutrophils, total neutrophils, white blood cell (WBC), red blood cell (RBC) counts, hemoglobin, hematocrit count, mean corpuscle hemoglobin (MCH) and mean corpuscle volume (MCV) were analyzed as safety parameters. The number of participants with values outside the reference range (potential clinical concern ) at any time on treatment (ATOT) and follow-up period were reported. The treatment period was till W104 followed by 6 weeks of follow-up period till W110 of study.|Up to 82 weeks|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2795947|NCT00550420|Secondary|Change From Baseline in Non-fasting Measures of Lipid Metabolism Including Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein and Triglycerides at Indicated Timepoints.|Non-fasting measures of lipid metabolism including cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (TG) were measured at Baseline (W0), W4, W16, W36, W52, Year 2 W24 and Follow-up. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was calculated as the value at the indicated visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W16, W36, W52, W76, and W82|All subject population. Only those participants available at the indicated time points were analyzed.|||Millimoles per litre||Standard Deviation|Mean
2795948|NCT00550420|Secondary|Number of Participants With Abnormal BW at Any Time During Treatment Period|BW of participants were recorded as vital sign at each visit. The BW were identified as of potential clinical concern if the vales were increased or decreased from Baseline by >=7%. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline in BW was measured as the BW value at specified visit minus the Baseline BW value. Number of participants with abnormal BW at any time during treatment period were reported.|Baseline (Visit 1, W0) to W 52|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2795949|NCT00550420|Secondary|Change From Baseline in Body Weight (BW)|BW of participants were recorded as vital sign at each visit. The BW were identified as of potential clinical concern if the vales were increased or decreased from Baseline by >=7%. The Baseline assessments were referred to assessments at Visit 1 (W0). Change from Baseline was measured as the BW at specified visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)|All subject population. Only those participants available at the indicated time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
2795950|NCT00550420|Secondary|Number of Participants With Abnormal HR at Any Time During Treatment Period|HR of participants was recorded as vital sign at each visit. The HR values were identified as of potential clinical concern if the vales were out of the reference range 50 to 100 beats per minute (BPM) or meet a change from Baseline criterion. The change from Baseline criterion was as, increase in HR (high) from Baseline if HR was increased by >= 30 bpm or decrease in HR (Low) from Baseline if HR was decreased by >= 30 bpm from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the HR at specified visit minus the Baseline value. Number of participants with abnormal HR at any time during treatment period were reported.|Up to 82 weeks|All subject population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2795961|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.|||points on a scale||Standard Deviation|Mean
2795951|NCT00550420|Secondary|Number of Participants With Abnormal SBP and DBP at Any Time During Treatment Period|SBP and DBP of participant were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the vales were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from Baseline criterion. The change from Baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase form Baseline (high) if increased by >= 30 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.|Up to 82 weeks|All subjects population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2795952|NCT00550420|Secondary|Change From Baseline in Heart Rate (HR)|HR of participants was recorded as vital sign at each visit. The HR values were identified as of potential clinical concern if the vales were out of the reference range 50 to 100 beats per minute (BPM) or meet a change from Baseline criterion. The change from Baseline criterion was as, increase in HR (high) from Baseline if HR was increased by >= 30 bpm or decrease in HR (Low) from Baseline if HR was decreased by >= 30 bpm from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the HR at specified visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)|All subject population. Only those participants available at the indicated time points were analyzed.|||BPM||Standard Deviation|Mean
2795953|NCT00550420|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP of participant were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the vales were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from Baseline criterion. The change from Baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase form Baseline (high) if increased by >= 30 mmHg from Baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. The Baseline assessments were referred to assessments at Visit 1 (W 0). Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.|Baseline (Visit 1, W0), W4, W8, W12, W16, W24, W36, W52, W64 and Follow-up (W82)|All subjects population. Only those participants available at the indicated time points were analyzed.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2795954|NCT00550420|Secondary|Percentage of Participants With AEs of Edema|Edema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. Percentage of participants reported with edema as AESI were reported.|Up to 82 Weeks|All subject population|||Percentage of participants|||Number
2795955|NCT00550420|Secondary|Number of Participants With Serious AEs and Deaths|A serious adverse event is defined as any untoward medical occurrence that, at any dose results in death, life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. The SAEs and deaths are reported from Visit 1 (W0) till end of the follow-up period (W110)|Up to Week 82|All subject population|||Participants|||Count of Participants
2795956|NCT00550420|Primary|Number of Participants With Any Adverse Events (AEs) and Severity of AEs|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The drug related-AEs of special interest (AESI) was reported. The severity of the AESI was categorized as mild, moderate and severe. Number of participants with AEs were reported for treatment duration of the study.|Up to Week 82|All subject population was comprised of all participants who took at least one dose of open-label study medication.|||Participants|||Count of Participants
2795957|NCT00550407|Post-Hoc|Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode|The number of participants with intervention for a manic, hypomanic, or mixed episode was measured. The necessity of the intervention was determined by the Investigator's discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for manic, hypomanic, or mixed episode (TIMan). Data from participants who had not met TIMan were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
2795958|NCT00550407|Post-Hoc|Number of Participants With Intervention for Depressive Episode|The number of participants with intervention for depressive episode was measured. The necessity of the intervention was determined by the Investigator's discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for depressive episode (TIDep). Data from participants who had not met TIDep were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
2795959|NCT00550407|Post-Hoc|Number of Participants With Intervention for Any Mood Episode|The number of participants with intervention for any mood episode was measured. The necessity of the intervention was determined by the Investigator's discretion. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to intervention for any mood episode (TIME). See the outcome measure for TIME for data for the Placebo group. Data from participants who had not met TIME were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
2795960|NCT00550407|Post-Hoc|Number of Participants With a Withdrawal Event|The number of participants who withdrew from the study was measured. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to study withdrawal. See the primary outcome measure for time to study withdrawal data for the Placebo group. Data from participants who had not withdrawn were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2|||participants|||Number
2795974|NCT00550394|Primary|Percentage of Days Abstinent|Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)||||Percentage of days abstinent||Standard Deviation|Mean
2795963|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.|||points on a scale||Standard Deviation|Mean
2795964|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
2795965|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-S at Week 16/Withdrawal.|||points on a scale||Standard Deviation|Mean
2795966|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
2795967|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 16/Withdrawal|Full Analysis Set in the Preliminary Phase (FAS1): all participants who received at least one dose of study medication for the Preliminary Phase and underwent at least one efficacy assessment after receiving the study medication in the Preliminary Phase. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-I.|||points on a scale||Standard Deviation|Mean
2795968|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 26/Withdrawal|FAS2|||points on a scale||Standard Deviation|Mean
2795969|NCT00550407|Secondary|Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)|"The TIMan was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of the relapse or recurrence of a manic, hypomanic, or mixed episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for a Manic, Hypomanic, or Mixed Episode for data related to TIMan."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In both groups, the estimated median TIMan was not calculable because the probability of not reaching TIMan remained greater than 0.50 throughout the study.||||||
2795970|NCT00550407|Secondary|Time to Intervention for Depressive Episode (TIDep)|"The TIDep was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for Depressive Episode for data related to TIDep."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIDep was not calculable because the probability of not reaching TIDep remained greater than 0.50 throughout the study. The upper limit of the confidence interval was not calculable for the Placebo group due to an insufficient number of events.||||||
2795971|NCT00550407|Secondary|Time to Intervention for Any Mood Episode (TIME)|"The TIME was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or electroconvulsive therapy (ECT) determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression or the recurrence of a manic, hypomanic, or mixed episode, whichever occurred first. Categorization as a manic, hypomanic, or mixed episode was left to the Investigator's discretion. See the outcome measure entitled Number of Participants with Intervention for Any Mood Episode for data related to TIME."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIME was not calculable because the probability of not reaching TIME remained greater than 0.50 throughout the study.|||days||95% Confidence Interval|Median
2795972|NCT00550407|Primary|Time to Withdrawal From Study|"The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled Number of Participants with a Withdrawal Event for data regarding the number of participants who withdrew from the study."|Randomization to Study Withdrawal (up to Week 26)|Full Analysis Set in Randomized (double-blind) Phase (FAS2): participants who received at least one dose of study medication in the Randomized Phase (RP) and had at least one post-treatment efficacy assessment in the RP. The upper limit of the confidence interval was not calculable for the Lamotrigine group due to an insufficient number of events.|||days||95% Confidence Interval|Median
2795973|NCT00550394|Primary|Percent Heavy Drinking Days|Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).|baseline to 12 weeks or endpoint (up to 11 weeks)||||Percent heavy drinking days||Standard Deviation|Mean
2795977|NCT00550368|Secondary|Intensity of Gastrointestinal Symptoms|Composite gastrointestinal symptom score was on a scale from 0 (no symptoms) to 15 (severe symptoms). This composite was the sum of 5 self-reported, symptom scores, each ranging from 0 (none) to 3 (severe). The self-reported symptoms that subjects scored were: malaise, headache, nausea, vomiting, and loose stool.|48 hours||||units on a scale||Full Range|Median
2795978|NCT00550368|Primary|Development of Diarrhea||48 hours||||participants|||Number
2795979|NCT00550290|Primary|Wound Complications|Number of participants experiencing wound complications following vulvectomy. The presence of febrile episodes, elevated WBC counts and exam findings will be used to diagnose wound complications.|Two-week post-operative|All participants who received their assigned dose of each intervention and completed all study visits were included in the efficacy analysis.|||Participants|||Count of Participants
2795980|NCT00550277|Secondary|Overall Response||18 months|||||||
2795981|NCT00550277|Secondary|To Evaluate the Toxicity of LBH589 in Patients With Refractory Advanced Clear Cell Renal Carcinoma||18 months|||||||
2795982|NCT00550277|Primary|To Evaluate the Efficacy of LBH589 in the Treatment of Patients With Refractory Clear Cell Carcinoma, as Measured by Progression-free Survival||18 months||||months||95% Confidence Interval|Median
2795983|NCT00550238|Primary|Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)|Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)|From first to last study drug dose plus 30 days|Enrolled patients who received at least 1 dose of study drug|||Participants|||Count of Participants
2795984|NCT00550173|Secondary|Probability of OS at 12 Months|OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.|Month 12|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.|||percent chance of survival||95% Confidence Interval|Number
2795985|NCT00550173|Secondary|Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status|EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.|Randomization to date of PD or death up to 38 months|A subset of the Q-ITT Population who had EGFR samples; Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.|||participants|||Number
2795986|NCT00550173|Secondary|Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)|TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).|Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months|A subset of the Q-ITT Population that included participants with LCSS results; Q-ITT Population: defined as all participants, with nonsquamous histology, who were randomized to therapy.|||months||95% Confidence Interval|Median
2795987|NCT00550173|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)|DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to disease progression up to 38 months|Q-ITT-TA Population: defined as all participants, with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.|||percentage of participants|||Number
2795988|NCT00550173|Secondary|Number of Participants With Adverse Events|A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.|Randomization up to 39 months|Safety Population defined as non-squamous participants who received at least 1 dose of study therapy (pemetrexed plus erlotinib or pemetrexed or erlotinib). One participant was assigned to pemetrexed (single therapy) but received erlotinib (single therapy) at first cycle and this lead to the discrepancy of participants for the safety analysis.|||participants|||Number
2795989|NCT00550173|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death from any cause.|Baseline to date of death from any cause up to 45.5 months|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy. Survival time was censored at the date of last contact for participants who were still alive or lost to follow-up, number of participants censored 35 (pemetrexed plus erlotinib), 44 (erlotinib) and 31 (pemetrexed).|||months||95% Confidence Interval|Median
2795990|NCT00550173|Secondary|Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Randomization to measured disease progression up to 38 months|Q-ITT Population - Tumor Analyzable (Q-ITT-TA) Population: defined as all participants with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.|||percentage of participants|||Number
2796088|NCT00549549|Secondary|Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events|The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)|Baseline to Day 14/Early Termination|ITT|||Participants|||Number
2795991|NCT00550173|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.|Randomization to measured PD up to 38 months|Qualified Intent to Treat (Q-ITT) Population defined as all participants with nonsquamous histology, who were randomized to therapy.|||months||95% Confidence Interval|Median
2795992|NCT00550147|Secondary|Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)|The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child.|See Arm/Group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
2795993|NCT00550147|Secondary|Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale|The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24.|See arm/group - repeated measures analysis|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
2795994|NCT00550147|Secondary|Modified Overt Aggression Scale (MOAS)|"The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates no aggression and a score of 235 indicates the most severe and frequent aggressive outbursts."|See arm/group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
2795995|NCT00550147|Secondary|CGI-S: Clinical Global Improvement Scale|"The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates normal, not ill at all and a score of 7 indicates among the most extremely ill patients."|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
2795996|NCT00550147|Primary|RAAPP: Rating of Aggression Against People and/or Property Scale|The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior).|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).|||units on a scale||Standard Deviation|Mean
2795997|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease|Subjects who achieved inactive disease based on DAS 28 CRP (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2795998|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease|Subjects who achieved inactive disease based on the DAS 28 ESR (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2795999|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Low Disease|Subjects who achieved low disease activity based on the DAS 28 CRP (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2796000|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Low Disease|Subjects who achieved low disease activity based on the DAS 28 ESR (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2796012|NCT00549939|Secondary|Detrusor Leak Point Pressure (LPP)|Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the Intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post-baseline LPP values. Patients were included in the treatment group to which they were allocated as per randomization.|||cmH2O||Standard Deviation|Mean
2796001|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2796002|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2796003|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 70 Improvement|"The ACR 70 is defined as ≥ 70% improvement in tender joint count plus~≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change."|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2796004|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 50 Improvement|The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2796005|NCT00550043|Primary|The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement|The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.|Day 28|modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).|||Percentage of participants|||Number
2796006|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.|52 weeks (double blind treatment period + open label extension treatment period)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received). It included 3 + 3 patients treated during the 1st treatment period only, 26 + 28 patients treated during the 2nd treatment period only and 54 + 55 patients treated during both periods.|||participants|||Number
2796007|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.~A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.|||participants|||Number
2796008|NCT00549939|Secondary|Relative Change in Detrusor Compliance|Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).|||percentage of mL/cmH2O||Standard Error|Least Squares Mean
2796009|NCT00549939|Secondary|Detrusor Compliance|"Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure.~It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet)."|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post baseline detrusor compliance values. Patients were included in the treatment group to which they were allocated as per randomization.|||mL/cmH20||Standard Deviation|Mean
2796010|NCT00549939|Secondary|Relative Change in Detrusor LPP|Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).|||percentage of cmH2O||Standard Error|Least Squares Mean
2796013|NCT00549939|Primary|Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O|"Detrusor Leak Point Pressure (LPP) was measured by cystometry.~For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained.~Investigators reading was then consolidated by the review of all cystometry data by 2 external Expert Reviewers, who were blinded for the study treatment.~The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion)."|12 weeks (double blind treatment period)|The Intent-to-treat (ITT) population was used for the analysis. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.|||participants|||Number
2796014|NCT00549900|Primary|Number of Subjects Reporting Medically Significant Adverse Events|Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month7)||||Participants|||Count of Participants
2796015|NCT00549900|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters|"Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells.~Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below."|At Month 0 and Month 7|Analysis was performed on subjects from the Total vaccinated cohort that completed the study.|||Participants|||Count of Participants
2796016|NCT00549900|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Day 0-29) after any vaccination||||Participants|||Count of Participants
2796017|NCT00549900|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Day 0-6) period following each vaccination||||Participants|||Count of Participants
2796018|NCT00549900|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Day 0-6) period following each vaccination||||Participants|||Count of Participants
2796019|NCT00549900|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
2796020|NCT00549822|Secondary|Serum HER-2/Neu Levels and Serum/Plasma Angiogenic Mediators|Measurements for the serum HER-2/neu (human epidermal growth factor receptor 2) levels and serum/plasma angiogenic mediators|2 years|Study terminated prematurely due to slow accrual. Outcome measure data not available for analysis.||||||
2796021|NCT00549822|Secondary|Median Time to Disease Progression With Intermittent Letrozole.|The median time to disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors).|3 years||||Months||Full Range|Median
2796022|NCT00549822|Primary|Number of Patients With Decline in Serum CA 15-3 (Carcinoma Antigen 15-3)|The Number of patients that have have a response of a decrease in CA 15-3 or CA 27.29 levels by at least 50% of that individual patient's baseline or peak level after re-introducing Letrozole therapy following a break in therapy as described in the intervention.|3 years||||Participants|||Count of Participants
2796023|NCT00549783|Secondary|Direct Costs for the United Kingdom|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom.|52 Weeks|Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection.|||British Pound (GBP)||Standard Deviation|Mean
2796024|NCT00549783|Secondary|Direct Costs for Sweden|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden.|52 Weeks|Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection.|||Swedish Krona (SEK)||Standard Deviation|Mean
2796025|NCT00549783|Secondary|Direct Costs for Germany|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany.|52 Weeks|Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection.|||Euro (EUR)||Standard Deviation|Mean
2796026|NCT00549783|Secondary|Direct Costs for Canada|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada.|52 Weeks|Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection.|||Canadian dollar (CAD)||Standard Deviation|Mean
2796027|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 52|Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Scores on a Scale||Standard Deviation|Mean
2796028|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 24|Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Scores on a Scale||Standard Deviation|Mean
2796029|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 12|Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Scores on a Scale||Standard Deviation|Mean
2796030|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
2796031|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
2796032|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
2796033|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
2796034|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
2796035|NCT00549783|Primary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24|Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.|||Percentage of Patients|||Number
2796036|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msSBP|Successful control in msSBP is defined as <140 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
2796037|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msDBP|Successful control in msDBP is defined as msDBP <90 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
2796038|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
2796039|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||Percentage of participants|||Number
2796040|NCT00549770|Secondary|Change From Baseline in Nighttime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am.|baseline, 8 weeks|Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only.|||mmHg||Standard Error|Least Squares Mean
2796041|NCT00549770|Secondary|Change From Baseline in Daytime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.|||mmHg||Standard Error|Least Squares Mean
2796042|NCT00549770|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.|||mmHg||Standard Error|Least Squares Mean
2796043|NCT00549770|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||mmHg||Standard Error|Least Squares Mean
2796044|NCT00549770|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.|||mmHg||Standard Error|Least Squares Mean
2796045|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).|||percentage of participants|||Number
2796046|NCT00549757|Other Pre-specified|Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)|"The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:~Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)~Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms."|Baseline to Month 3 and Month 6|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2796047|NCT00549757|Other Pre-specified|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)|"Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.~Change from Baseline = Post - Baseline."|Baseline, Month 6 , last measurement (maximum at 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included.|||mg/mmol||95% Confidence Interval|Geometric Mean
2796048|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures|Time from randomization to the first event (Maximum 50 months)|Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received.|||percentage of participants|||Number
2796049|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796050|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796051|NCT00549757|Primary|Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796052|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)||||percentage of participants|||Number
2796053|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796054|NCT00549757|Primary|Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796055|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796056|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796057|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.|||percentage of participants|||Number
2796058|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796059|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796060|NCT00549757|Primary|Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796061|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).|||percentage of participants|||Number
2796062|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)"|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).|||percentage of participants|||Number
2796063|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796075|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|8 weeks|Intention to Treat. subjects with missing information were assumed to be using tobacco.|||participants|||Number
2796064|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)"|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796065|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796066|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796067|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796068|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)|Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796069|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796070|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.|||percentage of participants|||Number
2796071|NCT00549718|Primary|Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2796072|NCT00549718|Secondary|CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2796073|NCT00549640|Secondary|The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.|The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe).|baseline and 14 days|Analysis was restricted to subjects who had diary information available for the first 14 days following target quit date|||units on a scale||Standard Deviation|Mean
2796074|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|6 months|Intention to treat (ITT). subject who discontinued study participation were counted as using tobacco.|||participants|||Number
2796076|NCT00549601|Secondary|Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3|The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline to Month 1 and Month 3|The Safety population was made up of all the randomized patients who had taken at least one dose of the study medication.|||Units on a scale||Standard Deviation|Mean
2796077|NCT00549601|Secondary|Overall Patient Satisfaction With Treatment|"Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 Very good - 5 Very poor) at the end of the study (Month 3). A higher score indicates less satisfaction."|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Participants|||Number
2796078|NCT00549601|Secondary|Overall Caregiver Satisfaction With Treatment|"Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 Very good - 5 Very poor) at the end of the study (Month 3). A higher score indicates less satisfaction."|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Participants|||Number
2796079|NCT00549601|Secondary|Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.|Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken.|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Percentage of participants|||Number
2796080|NCT00549601|Secondary|Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)|Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Percentage of participants|||Number
2796081|NCT00549601|Primary|Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study|Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.|||Percentage of participants|||Number
2796082|NCT00549562|Secondary|The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain|The VABS Maladaptive Behavior Domain measures undesirable behaviors that may interfere with an individual's adaptive functioning. The Maladaptive Domain consists two parts. Part I contains 27 minor maladaptive items and Part II contains 9 serious maladaptive behaviors. Each item is scored from 0 (never or seldom engages in the activity) to 2(usually or habitually engages in the activity). Part 1 yields a score of 0 to 54. Part II yields a score of 0 to 18. Both parts are combined to make a Total Score of 0 to 72. High scores of maladaptive behaviors reflect more negative behavior.|Week 8||||units on a scale||Standard Deviation|Mean
2796083|NCT00549562|Secondary|The Social Responsiveness Scale|The Social Responsiveness Scale (SRS) is a 65-item parent completed scale that assesses social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 1 (not true) to 3 (almost always true). Interpretation in this study is based on a total score that is proportional to the level of impairment in reciprocal social behavior. Scores within 0-53 are within normal limits. Scores within 54-86 indicate mild to moderate impairment. Scores above 87 indicate severe impairment.|Week 8||||units on a scale||Standard Deviation|Mean
2796084|NCT00549562|Secondary|The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders|The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders (CY-BOCS-PDD) is semi-structured clinician rating scale designed to rate the current severity of repetitive behavior in children and adolescents with PDD. The scale consists of 5 items: Time Spent, Interference, Distress, Resistance and Control. Each item is scored from 0 (None) to 4 (Extreme). The scale yields a Total Score from 0 (least symptomatic) to 20 (most symptomatic). Higher scores indicate greater severity of repetitive behavior.|Week 8||||units on a scale||Standard Deviation|Mean
2796085|NCT00549562|Primary|The Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each item is rated from 0 (not at all to 3 (severe). The ABC has 5 subscales:Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe) and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe).|Week 8||||units on a scale||Standard Deviation|Mean
2796086|NCT00549562|Primary|The Clinical Global Impression-Improvement(CGI-I)|The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point.|Week 8||||units on a scale||Standard Deviation|Mean
2796087|NCT00549549|Secondary|Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events|The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.|Baseline to Day 14/Early Termination|ITT|||Participants|||Number
2800037|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
2796089|NCT00549549|Secondary|Participants Global Evaluation of Study Medication Score|"The participant rated the study medication that they received during the study by completing the following question:~How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor"|Day 9|ITT|||Scores on a scale||Standard Deviation|Mean
2796090|NCT00549549|Secondary|Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy|Withdrawal due to lack of efficacy was assessed from Days 1 to 8|Day 1 to Day 8|ITT|||Participants|||Number
2796091|NCT00549549|Secondary|Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13|The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.|Baseline to Day 13|ITT, LOCF|||Percentage change||Standard Deviation|Mean
2796092|NCT00549549|Secondary|Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline|The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline|ITT, LOCF|||Units on a scale||Standard Deviation|Mean
2796093|NCT00549549|Secondary|Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity|The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2|ITT and LOCF|||Participants|||Number
2796094|NCT00549549|Secondary|Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours|Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity|Baseline, 8, 12, and 24 hours post first dose|ITT and LOCF|||Scores on a scale||Standard Deviation|Mean
2796095|NCT00549549|Secondary|Change From Baseline in Patient's Assessment of Pain Intensity on Day 1|The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).|Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
2796096|NCT00549549|Secondary|Change From Baseline in Patient's Assessment of Pain Intensity|The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2 to Day 13|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
2796097|NCT00549549|Secondary|Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14|Warmth was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Participants|||Number
2796098|NCT00549549|Secondary|Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination|Redness was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Participants|||Number
2796099|NCT00549549|Secondary|Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling|Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)|Baseline, Days 5, 9 and 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
2796100|NCT00549549|Secondary|Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness|Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).|Baseline, Day 5, Day 9, and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF|||Scores on a scale||Standard Deviation|Mean
2796101|NCT00549549|Primary|Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity|The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).|Baseline and Day 2|Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2796102|NCT00549445|Primary|Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.|"Nasopharyngeal swabs were obtained to determine if there is a reduction in PGP levels (including both PGP & Neutrophil-PGP) after chronic treatment with azithromycin.~Unblinding of the parent trial revealed that there were 18 sputum samples from 13 placebo-treated participants and 14 sputum samples from 8 azithromycin-treated participants collected at months 1 through 12 of treatment (with sputum samples not being available, this greatly reduced the sample size)."|Baseline to 12 months|Levels of PGP from sputum samples are compared between subjects on the macrolide antibiotic, azithromycin, and subjects on placebo and correlated with neutrophil counts and protease activity in sputum.|||ng/mL||Full Range|Mean
2796103|NCT00549393|Other Pre-specified|Bacteremia|per protocol analysis of incidence of bacteremia comparing those in treatment and control groups|duration of ICU stay, median 3 days|Includes per protocol population of 1547 of 2422 in the treatment arm|||events per 1000 at-risk days||95% Confidence Interval|Number
2796104|NCT00549393|Secondary|Central Line Associated-bloodstream Infection (CLABSI)|Comparing incidence of central line-associated bloodstream infections between treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days||||events per 1000 at-risk days||95% Confidence Interval|Number
2796105|NCT00549393|Primary|Bacteremia|incidence of bacteremia comparing those in treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days|Intent to treat population|||events per 1000 at-risk days||95% Confidence Interval|Number
2796106|NCT00549328|Secondary|Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
2796107|NCT00549328|Secondary|Levels of Circulating Biomarkers in Plasma|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
2796108|NCT00549328|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
2796109|NCT00549328|Secondary|Progression-Free Survival|Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
2796110|NCT00549328|Secondary|Number of Participants Who Had a Complete or Partial Response, or Stable Disease|Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population||||||
2796111|NCT00549328|Primary|Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria|The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population: all participants who met inclusion criteria and willingly consented to participate in the study||||||
2796112|NCT00549302|Secondary|Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52|World Health Organization Functional Classification Assessment (WHO FC) is a method of classifying disease severity in PAH. The classes are: Class I: pulmonary hypertension (PH) but without resulting limitation of physical activity, Class II: PH resulting in slight limitation of physical activity, Class III: PH resulting in marked limitation of physical activity, Class IV: PH with inability to carry out any physical activity without symptoms. Deterioration of WHO FC is defined as moving to a higher WHO FC within one visit. Results are presented as Kaplan-Meier estimates (% probability) of remaining free from WHO FC deterioration after a given time.|Baseline and Weeks 16, 28, 40 and 52|Safety Population: all randomized participants who received at least 1 dose of study drug.|||probability (%) no PAH deterioration||95% Confidence Interval|Number
2796113|NCT00549302|Secondary|Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52|Borg dyspnea score is a participant rated measure of their greatest degree of shortness of breath during exertion (6-minute walk test). Score ranged from 0 (nothing at all) to 10 (very, very severe [maximal]).|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed the Borg Dyspnea Assessment; LOCF|||units on a scale||Standard Deviation|Mean
2796114|NCT00549302|Secondary|6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52|6MWD measured the distance a participant was able to walk unassisted in 6 minutes.|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed 6MWD test; Last Observation Carried Forward (LOCF)|||meters (m)||Standard Deviation|Mean
2796115|NCT00549302|Primary|Number of Participants With Adverse Events (AEs)|A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.|Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)|Safety Population: all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2796116|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||ug/L||95% Confidence Interval|Geometric Mean
2796117|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||ug/L||95% Confidence Interval|Geometric Mean
2796118|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||nanograms per Liter (ng/L)||95% Confidence Interval|Geometric Mean
2802660|NCT00508027|Other Pre-specified|Change in Plasma Hs-CRP Levels|Change in plasma high sensitivity C-reactive protein levels in subjects treated with simvastatin|Baseline, 21 days||||mg/L||Standard Deviation|Mean
2796119|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96|P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.|||micrograms per Liter (ug/L)||95% Confidence Interval|Geometric Mean
2796120|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
2796121|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
2796122|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).|Baseline, Week 96|Safety Population. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
2796123|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.|||ratio||95% Confidence Interval|Geometric Mean
2796124|NCT00549198|Secondary|"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"|Participants were asked at each visit whether or not they utilized unplanned healthcare resources.|Baseline to Week 96|ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.|||participants|||Number
2796125|NCT00549198|Secondary|Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96|Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.|Week 96|On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.|||participants|||Number
2796126|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||cells/mm^3||Inter-Quartile Range|Median
2796127|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||cells/mm^3||Inter-Quartile Range|Median
2796128|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.|||cells/millimeters cubed (mm^3)||Inter-Quartile Range|Median
2796129|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 96|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.|||participants|||Number
2796425|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Alogia|SANS Global Rating of Alogia. Scores can range from 0-5, with higher scores indicating more severe alogia.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796130|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 48|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.|||participants|||Number
2796131|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 24|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.|||participants|||Number
2796132|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.|Week 96|Safety Population|||participants|||Number
2796133|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 48|Safety Population|||participants|||Number
2796134|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 24|Safety Population|||participants|||Number
2796135|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.|Baseline, Week 96|Safety Population|||participants|||Number
2796136|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 48|Safety Population|||participants|||Number
2796137|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 24|Safety Population|||participants|||Number
2796138|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 96|Safety Population|||participants|||Number
2796139|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 48|Safety Population|||participants|||Number
2796140|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 24|Safety Population|||participants|||Number
2796141|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 96|Safety Population|||participants|||Number
2796142|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 48|Safety Population|||participants|||Number
2796157|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population|||percent change||Standard Error|Mean
2796143|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 24|Safety Population|||participants|||Number
2796144|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 96|Safety Population|||participants|||Number
2796145|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 48|Safety Population|||participants|||Number
2796146|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 24|Safety Population|||participants|||Number
2796147|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 96|Safety Population: all randomized participants who received at least one dose of study medication|||participants|||Number
2796148|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 48|Safety Population: all randomized participants who received at least one dose of study medication|||participants|||Number
2796149|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 24|Safety Population: all randomized participants who received at least one dose of study medication|||participants|||Number
2796150|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||participants|||Number
2796151|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||participants|||Number
2796152|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 24|ITT-E Population. Some participants had withdrawn by Week 24.|||participants|||Number
2796153|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.|||participants|||Number
2796154|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.|||participants|||Number
2796155|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.|||participants|||Number
2796156|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population|||percent change||Standard Error|Mean
2800038|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
2796158|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population|||percent change||Standard Error|Mean
2796159|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population|||percent change||Standard Error|Mean
2796160|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population|||percent change||Standard Error|Mean
2796161|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population|||percent change||Standard Error|Mean
2796162|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||participants|||Number
2796163|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||participants|||Number
2796164|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.|||participants|||Number
2796165|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.|||participants|||Number
2796166|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.|||participants|||Number
2796167|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 24|ITT-E Population. Some participants had withdrawn from the study by Week 24.|||participants|||Number
2796168|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 96|ITT-E Population|||mL/min||Standard Error|Mean
2796169|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 48|ITT-E Population|||mL/min||Standard Error|Mean
2796170|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.|Baseline, Week 24|ITT-E Population|||mL/min||Standard Error|Mean
2796171|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.|Baseline, Week 96|ITT-E Population|||mL/min/1.73m^2||Standard Error|Mean
2796172|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.|Baseline, Week 24|ITT-E Population|||mL/min/1.73m^2||Standard Error|Mean
2796173|NCT00549198|Primary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.|Baseline, Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication|||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
2796174|NCT00549172|Secondary|Cost Effectiveness|Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.|1 and 2 years||2018-11-30|11/2018||||
2796175|NCT00549172|Secondary|Pain at Rest (VAS)|Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year||||units on a scale||95% Confidence Interval|Mean
2796176|NCT00549172|Secondary|15-D (General Quality of Life -Assessment Tool)|The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).|One year||||units on a scale||95% Confidence Interval|Mean
2796177|NCT00549172|Primary|WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)|The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.|One year||||units on a scale||95% Confidence Interval|Mean
2796178|NCT00549172|Primary|Pain After Exercise (VAS)|Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year||||units on a scale||95% Confidence Interval|Mean
2796179|NCT00549172|Primary|The Lysholm Knee Score|The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.|One year||||units on a scale||95% Confidence Interval|Mean
2796180|NCT00549055|Secondary|Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments|Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).|Months 3, 6, 9 and 12|FAS|||Participants|||Number
2796181|NCT00549055|Secondary|Frequency of Macugen Administration|Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.|Baseline up to 28.4 months|FAS|||Weeks per injection||Standard Deviation|Mean
2796182|NCT00549055|Secondary|Duration of Treatment|Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).|Baseline up to 28.4 months|FAS|||Months||Standard Deviation|Mean
2796183|NCT00549055|Secondary|Number of Participants With Change in VA: Worsening|Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.|||Participants|||Number
2796184|NCT00549055|Secondary|Number of Participants With Change in VA: Stabilization|Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.|||Participants|||Number
2796185|NCT00549055|Secondary|Number of Participants With Change in VA: Improvement|Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.|||Participants|||Number
2796186|NCT00549055|Primary|Change From Baseline to Final Visit in Visual Acuity (VA) Score|Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.|Baseline, Month 24 or Early Termination|The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data.|||Scores on scale||Standard Deviation|Mean
2796187|NCT00548886|Secondary|Determine Interobserver Variability When Measuring QT Intervals|Two pediatric electrophysiologists were given photocopies of rhythm strips obtained from the electrocardiograms and the electrophysiologists will then take four separate measurements of the QT interval from each rhythm strip. Interobserver variability was measured between the two electrophysiologists and their measurements on the same rhythm strip. False positive results will be based on measurement error.|During enrollment period|Interobserver variability was not performed due to study termination||||||
2796241|NCT00548327|Other Pre-specified|Blood Plasma Concentration of Atomoxetine|Blood for drug plasma levels is obtained before and 3 hours after dosing on the 14th day receiving Atomoxetine.|before and 3 hours after dosing on the 14th day receiving Atomoxetine|Data were not collected for analysis because the study was terminated before target accrual||||||
2796188|NCT00548886|Primary|Percentage of Subjects With a Positive Result in Absolute QT Interval|QT interval refers to the time interval on the standard electrocardiogram from the beginning of the QRS complex to the end of the T wave. Each participant had four QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint for an absolute QT interval. Lengthening of the absolute QT interval greater than 30 milliseconds on low dose epinephrine infusion would be considered a positive result.|35 minutes|Data not analyzed due to study termination||||||
2796189|NCT00548860|Primary|Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.|Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).|From Day 0 through 30 days after the last dose of study drug.||||participants|||Number
2796190|NCT00548847|Secondary|Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells)||6 months after cytokine treatment||||participants|||Number
2796191|NCT00548847|Primary|Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months|Efficacy is defined as progression-free survival of > 33% at 3 months. This is based on our retrospective data on 10% 3 month survival for relapsed patients. Progression is defined an an increase in blasts in blood or marrow by 50% compared to baseline with at least 20% of all cells being blasts at the time of assessment.|3 months after cytokine treatment||||percentage of progression-free patients|||Number
2796192|NCT00548808|Secondary|Safety: Number of Participants With Serious and Non-Serious Adverse Events|Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.|baseline through 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug.|||participants|||Number
2796193|NCT00548808|Secondary|Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles||baseline, 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug and had baseline and endpoint values.|||millimoles/Liter (mmol/L)||Standard Error|Least Squares Mean
2796194|NCT00548808|Secondary|Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.|||Units of insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
2796195|NCT00548808|Secondary|Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.|||Units of insulin per day (U/day)||Standard Deviation|Mean
2796196|NCT00548808|Secondary|Change From Baseline in Postprandial Blood Glucose Over Time|The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.|||millimoles per liter||Standard Error|Least Squares Mean
2796197|NCT00548808|Secondary|7-point Self-monitored Blood Glucose Profiles||Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2796198|NCT00548808|Secondary|Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time||16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.|||percentage of participants|||Number
2796199|NCT00548808|Secondary|Change in Hemoglobin A1c (HbA1c) Over Time||Baseline, 16 Weeks, 32 Weeks, 48 Weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study.|||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
2796200|NCT00548808|Primary|Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 48 weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study. Last observation carried forward.|||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
2796201|NCT00548717|Secondary|Overall Survival||1 year||||percentage of participants|||Number
2796202|NCT00548717|Secondary|Incidence of Chronic GVHD|"Chronic GVHD will be graded according to the modified Seattle criteria. Chronic GVHD divided into limited and extensive and evaluated across the following systems: skin, cutaneous structures, liver, mouth, eyes, esophagus, intestines, lung, musculoskeletal, serous, nervous, urologic, vagina, hematopoietic, and immune.~Localized skin involvement with or without hepatic dysfunction is classified as limited disease.~Generalized skin involvement or limited disease plus eye involvement, oral involvement, hepatic dysfunction with abnormal liver histology, or involvement of any other target organ was classified as extensive disease.~Lee SJ, Vogelsang G, Flowers ME. Chronic graft‐versus‐host disease. Biol Blood Marrow Transplant.~2003;9:215‐33."|1 year||||percentage of participants|||Number
2796203|NCT00548717|Secondary|Incidence of 100 Day Mortality||100 days||||percentage of participants|||Number
2796204|NCT00548717|Secondary|To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence|This outcome measure was presented as a comparison between incidence of Grade 0-I aGVHD and Grade II-IV aGVHD across 5 time points (Weeks 1,2,3,8, and 12).|1 year|In the Siro/MMF group, the overall number of participants analyzed was 13, however, the number of participants with the MMF level data available varies at each time point. For the Siro/MMF/Bort group, no data were analyzed due to no data available for this Outcome Measure.|||ng/mL||Standard Deviation|Mean
2796242|NCT00548327|Secondary|Change in The Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a psychological questionnaire to rate the severity of anxiety.It contains 14 symptom-oriented questions.Each of these symptoms is given a severity rating, from not present(scored as 0)to very severe(scored as 4)|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual||||||
2796205|NCT00548717|Secondary|The Rate of Renal Insufficiency|"Renal function will be measured weekly after transplant for 4 weeks, at 8 weeks and then at 3 month intervals from transplantation. Sentinel renal events such as the occurrence of thrombotic microangiopathy will be noted.~The rationale for the substitution of mycophenolate mofetil for tacrolimus is to continue to prevent acute GVHD, but minimize renal toxicity after transplantation. We will thus monitor renal toxicity closely in this study. In our previous experience, the rate of grade III‐V renal toxicity by day 100 after transplantation was about 10%. Here, grade III is defined as a creatinine level between 3.1 to 6 times the normal level, grade IV is defined as a creatinine level 6 times or more the normal level, and grade V is defined as a fatality due to renal toxicity."|1 year|One patient experienced grade 5 renal toxicity|||participants|||Number
2796206|NCT00548717|Secondary|Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant|Engraftment of donor cells by week 4 after transplantation. Assessment of donor stem cell engraftment will include donor-host hematopoietic chimerism analyses at 4 weeks and every 3 months after transplantation. Chimerism measured from peripheral blood or from bone marrow.|30 days||||participants|||Number
2796207|NCT00548717|Primary|To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies||150 days||||percentage of participants|||Number
2796208|NCT00548691|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAE's)||from Day 0 through 30 days after the last dose of study drug||||participants|||Number
2796209|NCT00548652|Secondary|Change in Weight|value at 6 months minus value at baseline|6 months||||Kg||Standard Deviation|Mean
2796210|NCT00548652|Primary|Apathy Evaluation Scale|Apathy Evaluation Scale (AES) measures apathy over the previous four weeks Scale range: 18 (minimum score)- 72 (Maximum score) Higher scores indicate higher apathy Better outcome would be reduction in the score|6 months||||units on a scale||Standard Deviation|Mean
2796211|NCT00548548|Secondary|Participants With Adverse Events|The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|From randomization until 3 months after last dose (up to 26 months)|Safety population, including all patients randomized and exposed to study medication (defined as any one component of the combination). Patients are assigned to treatment groups based on the treatment they actually received.|||participants|||Number
2796212|NCT00548548|Secondary|Participants With Disease Control|Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks.|From randomization until the end of study, up to 26 months.|Intent-to-treat|||participants|||Number
2796213|NCT00548548|Secondary|Duration of Response|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method.|From randomization to the end of study, up to 26 months|Participants with measurable disease at baseline who had a best overall response of complete response or partial response, and for whom duration of response data was available.|||months||95% Confidence Interval|Median
2796214|NCT00548548|Secondary|Participants With a Best Overall Response of Complete or Partial Response|Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s).|From randomization until the end of study, up to 26 months.|Measurable Disease Population, including all randomized participants with measurable disease (per RECIST) for gastric cancer at baseline. Patients were analyzed according to the treatment groups to which they were randomized.|||participants|||Number
2796215|NCT00548548|Secondary|Time to Disease Progression|Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method.|From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months.|Intent-to-treat|||months||95% Confidence Interval|Median
2796216|NCT00548548|Secondary|Progression-free Survival During First-line Therapy|Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method.|From randomization until 28-days after the last study treatment was administered, up to 26 months.|Intent-to treat.|||months||95% Confidence Interval|Median
2796603|NCT00546429|Primary|Success in Terms of the Merle D'Aubigne Score|Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.|4 weeks, 3, 6 and 12 months||||Units on a scale||Standard Deviation|Mean
2796217|NCT00548548|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method.|From randomization until disease progression or death, up to 26 months.|Intent to treat|||months||95% Confidence Interval|Median
2796218|NCT00548548|Primary|Overall Survival|The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.|From randomization until death, up to 26 months|The Intent-to-Treat population, including all randomized participants.|||months||95% Confidence Interval|Median
2796219|NCT00548470|Secondary|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology.|Baseline and 2 months later||||Units on the PANSS scale||Standard Deviation|Mean
2796220|NCT00548470|Secondary|RBANS Neuropsychological Battery|The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability.|baseline and month 2 of treatment||||RBANS scores||Standard Deviation|Mean
2796221|NCT00548470|Primary|Plasma Cotinine|cotinine level in plasma ng/ml.|baseline 1 month and 2 months||||ng/ml||Standard Deviation|Mean
2796222|NCT00548470|Primary|CO (Carbon Monoxide) Breathalyzer Level|Carbon Monoxide in breath ,parts per million|baseline and during 2 months of treatment||||ppm (carbon monoxide parts per million)||Standard Deviation|Mean
2796223|NCT00548470|Primary|Self Report of Smoking|Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.|Baseline and during 2 months of treatment||||Cigarettes||Standard Deviation|Mean
2796224|NCT00548431|Secondary|Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production|Biweekly bloodsamples during the 3 months are analyzed for 6TGN incorporation into leucocyte DNA. In addition Methylated Mercaptopurine (MeMP) and Erythrocyte-Methotrexate level is measured|During the 3 months consolidation therapy||2018-02-28|02/2018||||
2796225|NCT00548431|Primary|Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported|Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.|3 months ( 79 days )||||Participants|||Number
2796226|NCT00548418|Secondary|Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies||When specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.||||||
2796227|NCT00548418|Secondary|Correlate Patterns of Gene Expression as Assessed by Microarrays||Correlative studies when specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.||||||
2796228|NCT00548418|Secondary|Frequency of Response as Measured by RECIST Criteria (Imaging)|"RECIST criteria:~Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions~Stable disease is any condition not meeting the above criteria"|Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)|26 participants were evaluable for response.|||participants|||Number
2796229|NCT00548418|Secondary|Overall Survival|Defined as time from study entry until death from any cause or date of last contaqct.|Until death (follow-up ranged from 1.7 months to 33.4 months)||||months||90% Confidence Interval|Median
2796230|NCT00548418|Primary|Anti-tumor Activity as Measured by Surviving Progression-free|Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.|Progression-free survival at 6 months||||percentage of participants|||Number
2796231|NCT00548405|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||percent change||Standard Deviation|Mean
2796604|NCT00546390|Secondary|All-cause Death and Cardiovascular Long-term Outcome|Death and re-hospitalization due to any cause including heart and renal failure and new atrial fibrillation|6-month cardiovascular outcome||||Participants|||Count of Participants
2796232|NCT00548405|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||Z-score||Standard Deviation|Mean
2796233|NCT00548405|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||units on a scale||Standard Deviation|Mean
2796234|NCT00548405|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||percentage of participants||95% Confidence Interval|Number
2796235|NCT00548405|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.|||relapses per participant per year||95% Confidence Interval|Number
2796236|NCT00548405|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.|||percentage of participants||95% Confidence Interval|Number
2796237|NCT00548340|Post-Hoc|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 22 and 29. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.|||minutes||Standard Error|Mean
2796238|NCT00548340|Post-Hoc|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.|||minutes||Standard Error|Mean
2796239|NCT00548340|Secondary|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.|||minutes||Standard Error|Mean
2796240|NCT00548340|Primary|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.|||minutes||Standard Error|Mean
2805700|NCT00482677|Primary|Overall Survival|Time from date of randomization to the date of death of any causes, or censored at last known alive date.|7 years||||Months||95% Confidence Interval|Median
2796243|NCT00548327|Secondary|Change in The Profile of Mood States|The Profile of Mood States is an instrument that provides a rapid method of assessing transient, fluctuating mood states. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1)tension-anxiety, 2)depression-dejection, 3)anger-hostility, 4)fatigue-inertia, 5)vigor-activity and 6)Confusion-bewilderment.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual||||||
2796244|NCT00548327|Primary|Changes in Cognitive Function Measured by Neuropsychological Testing|Neuropsychological testing consists of a battery of 10-12 individual tests to measure cognitive function. We expect both a drug effect and a genotype effect on neuropsychological tasks that measure dorsolateral prefrontal cortex (DLPFC) executive function, mostly in individuals who share the val/val genotype with respect to the met/met genotype.|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual||||||
2796245|NCT00548327|Secondary|Change in The Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a 7-point rating scale with (1) indicating the absence of a symptom or behavior and (7) indicating the most severe symptom. The PANSS includes three scales(Positive and Negative Syndromes and General Psychopathology)and five clusters (Anergia, Thought Disturbance, Activation, Paranoid/Belligerence and Depression.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual||||||
2796246|NCT00548327|Primary|Changes in Functional Magnetic Resonance Imaging (fMRI) Blood-oxygen-level-dependent (Bold) Activity|"Main outcome measures were BOLD fMRI response (activation) while performing a prefrontal cortex-dependent task such as N-Back Working Memory with increasing levels of task difficulty. It was expected to have a greater level of activation in BOLD fMRI in schizophrenic patients with respect to normal volunteers, and a greater activation in individuals (either normal volunteers or patients) who share the val/val genotype with respect to the met/met genotype.~Based on prior fMRI studies and on power analysis of neuropsychological variables, at least 28 and 26 subjects are respectively needed to achieve significant power in functional neuroimaging and neuropsychological studies.These sizes provide an 80% power to observe significant differences between drug conditions at the 0.05 level."|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual||||||
2796247|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)|Chemistry laboratory test data measured as international units per (IU/L).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.|||IU/L||Full Range|Median
2796248|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)|Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.|||mg/dL||Full Range|Median
2796249|NCT00548262|Secondary|Change From Baseline in Vital Signs: Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline to Week 2 Follow-up|Safety analysis population|||resp/min||Full Range|Median
2796250|NCT00548262|Secondary|Change From Baseline in Vital Signs: Temperature|Temperature measured as degrees of Celsius (C).|Baseline to Week 2 Follow-up|Safety analysis population|||Degrees of Celsius||Full Range|Median
2796251|NCT00548262|Secondary|Change From Baseline in Vital Signs: Weight|Weight measured as kilograms (kg).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with evaluable data.|||kg||Full Range|Median
2796252|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Heart Rate|Supine heart rate measured as beats per minute (bpm).|Baseline to Week 2 Follow-up|Safety analysis population|||bpm||Full Range|Median
2796253|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Blood Pressure|Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).|Baseline to Week 2 Follow-up|Safety analysis population|||mmHg||Full Range|Median
2796254|NCT00548262|Secondary|Length of Stay in Intensive Care Unit (ICU)|Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.|Baseline up to Week 6 Follow-up|MITT; N=number of participants evaluable for length of time in ICU.|||Days||95% Confidence Interval|Median
2796255|NCT00548262|Secondary|Length of Hospital Stay|Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.|Baseline to Week 6 Follow-up|MITT; data not summarized using descriptive statistics.|||days|||Number
2796256|NCT00548262|Secondary|Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment|Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.|Baseline to Day 42|Safety analysis set: all participants who received any dose of study medication.|||days||Full Range|Median
2796257|NCT00548262|Secondary|Time to Negative Blood, Specimen, or Tissue Culture|Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).|Baseline to Week 2 Follow-up|MITT; data not summarized using descriptive statistics.|||Days|||Number
2796258|NCT00548262|Secondary|Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis|"Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded disease under study as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone."|Baseline to Week 6 Follow-up|MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.|||participants|||Number
2796259|NCT00548262|Secondary|Number of Participants Per Survival Status (Alive or Dead) on Day 30||Day 30|MITT|||participants|||Number
2796260|NCT00548262|Secondary|Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.|EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
2796261|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, Week 2 Follow-up (F/U)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly >65 years of age; not summarized.|||participants|||Number
2796262|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|EIVT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly >65 years of age; not summarized.|||participants|||Number
2796263|NCT00548262|Secondary|Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, EOT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (>65 years of age); not summarized.|||participants|||Number
2796264|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.|||participants|||Number
2796265|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EOT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
2796266|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EIVT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
2796267|NCT00548262|Secondary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up|MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.|||participants|||Number
2796293|NCT00548171|Secondary|Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test|Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.|Prior the booster vaccination|This analysis was performed on those participants from the According to Protocol (ATP) cohort for antibody persistence who were found to be seronegative for anti-diphtheria antibodies as tested by ELISA.|||Participants|||Count of Participants
2796268|NCT00548262|Primary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Treatment (EOT) (up to Day 42)|Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.|||participants|||Number
2796269|NCT00548249|Secondary|Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.||two separate sessions measured one week apart.|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||Subjects|||Number
2796270|NCT00548249|Secondary|Estimate the Amount of SFP Transferred From the Dialysate to the Blood During a Dialysis Session.||At each dialysis session for up to 26 weeks|||||||
2796271|NCT00548249|Secondary|Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.||At each dialysis session for up to 26 weeks||||Subjects|||Number
2796272|NCT00548249|Secondary|Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.|Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).|Every 4 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||pg||Standard Deviation|Mean
2796273|NCT00548249|Secondary|Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.|Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL|Up to 26 weeks|"Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication.~Because of the small number of patients reaching the endpoint of decrease in Hgb >= 1.0 g/dL, the Kaplan-Meier analysis could not estimate the number of days for at least one treatment group for the 50th percentile and higher."|||Days|||Number
2796274|NCT00548249|Secondary|Change From Baseline in Hemoglobin (Hgb)||two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||grams/ deciliter (g/dL)||Standard Deviation|Mean
2796275|NCT00548249|Primary|Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.|Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).|up to 26 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication|||Percent of subjects|||Number
2796276|NCT00548197|Secondary|Anatomic Status of the Retina|Number of Participants with Postoperative Vitreous Hemorrhage|Last follow up, an average of 7 months post-operation|Postoperative Vitreous Hemorrhage|||Participants|||Count of Participants
2796277|NCT00548197|Primary|Best Corrected Visual Acuity|Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)|last follow up, an average of 7 months post-operation||||LogMar||Standard Deviation|Mean
2796278|NCT00548184|Other Pre-specified|Data Analysis of the Biomarkers: Immunohistochemical Staining of Cells From Breast Biopsies and Skin Biopsies Will be Performed.||one year|||||||
2796279|NCT00548184|Primary|Pathologic Assessment After Study Treatment|Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.|12 weeks|65 patients were enrolled and received the study treatment. 1 patient was found ineligible for this study therefore she was excluded from outcome report.|||participants|||Number
2796280|NCT00548171|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group."|Following the booster vaccination|The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2796281|NCT00548171|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.~For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group."|During the 31-day (Day 0-30) follow-up period after booster vaccination|The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2796292|NCT00548171|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.|Prior the booster vaccination|The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point|||Participants|||Count of Participants
2796282|NCT00548171|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.~For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group."|During the 4-day (Day 0-3) follow-up period after booster vaccination|The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2796283|NCT00548171|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.~For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group."|During the 4-day (Day 0-3) follow-up period after booster vaccination|The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2796284|NCT00548171|Secondary|Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL).|One month after the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||Participants|||Count of Participants
2796285|NCT00548171|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|Prior to (PRE) and one month after [PI(M1)] the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2796286|NCT00548171|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.|Prior to (PRE) and one month after [PI(M1)] the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||Participants|||Count of Participants
2796287|NCT00548171|Secondary|Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test|Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.|One month after the booster vaccination|This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA.|||Participants|||Count of Participants
2796288|NCT00548171|Secondary|Number of Seronegative Subjects for Anti-DT Antibodies - ELISA|Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.|One month after the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||Participants|||Count of Participants
2796289|NCT00548171|Secondary|Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.|Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.|Prior to the booster vaccination|This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA.|||Participants|||Count of Participants
2796290|NCT00548171|Secondary|Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.|Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.|Prior to the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||Participants|||Count of Participants
2796291|NCT00548171|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL)|Prior the booster vaccination|The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point|||EL.U/mL||95% Confidence Interval|Geometric Mean
2796347|NCT00547521|Secondary|Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy|HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.|||participants|||Number
2796294|NCT00548171|Secondary|Number of Seronegative Subjects for Anti-DT Antibodies - ELISA|Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.|Prior the booster vaccination|The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point|||Participants|||Count of Participants
2796295|NCT00548171|Secondary|Anti-DT and Anti-TT Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|Prior to the booster vaccination|The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point|||IU/mL||95% Confidence Interval|Geometric Mean
2796296|NCT00548171|Secondary|Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values|"Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL.~This endpoint presents results for subjects included in the ATP cohort for antibody persistence."|Prior (PRE) to booster vaccination|The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point|||Participants|||Count of Participants
2796297|NCT00548171|Secondary|Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after [PI(M1)] the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2796298|NCT00548171|Secondary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL.|Prior to (PRE) and one month after [PI(M1)] the booster vaccination|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||Participants|||Count of Participants
2796299|NCT00548171|Primary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL)|"Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).~The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster."|One month after the booster vaccination [PI(M1)]|The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.|||Participants|||Count of Participants
2796300|NCT00548145|Secondary|MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)|Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)|baseline and 12 months|||||||
2796301|NCT00548145|Primary|Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)|Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.|baseline and 12 months||||scores on a scale||Standard Deviation|Mean
2796302|NCT00548132|Secondary|Clinical Sepsis Episodes/Per 1000 Catheter Days|This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.|2 years||||sepsis episodes/1000 catheter days|||Number
2796303|NCT00548132|Primary|The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms|The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization|2 years|Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.|||BSIs /1000 catheter days|||Number
2796304|NCT00548093|Secondary|Percentage of Participants With Progression-free Survival (PFS)|"PFS is defined as time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Month 6|As-enrolled population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2796324|NCT00547911|Primary|Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
2796305|NCT00548093|Secondary|Dermatology Life Quality Index (DLQI) Score|Self-administered questionnaire to measure health-related quality of life (QoL) of adult participants suffering from skin disease; 10 questions concerning participants' perception of impact of their disease over last week encompassing aspects such as symptoms or feelings, daily activities, leisure, work or school, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual questions (0-3) were added to yield a total score (0-30); higher score = greater impairment of participant's QoL.|Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43|As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2796306|NCT00548093|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43|As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2796307|NCT00548093|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43|As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2796308|NCT00548093|Secondary|Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening|HER-family is a family of transmembrane protein that plays a pivotal role in growth factor signal transduction and Kirsten Rat Sarcoma (KRAS) gene is an oncogene that encodes a small guanosine triphosphatase (GTPase) transductor protein called KRAS. The mutation status of HER and KRAS genes in tumor DNA present in plasma was determined using a polymerase chain reaction (PCR)-based assay. The gene that is most common in a particular natural population is known as the wild type. Any form of the gene other than the wild type is known as a mutant form. Number of participants with HER-Family and KRAS gene mutation were classified as: wild type, mutant and unknown.|Screening|As-enrolled population included all participants who were enrolled in the study.|||Participants|||Count of Participants
2796309|NCT00548093|Secondary|Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum|Human epidermal growth factor receptor 2 (HER2) is a transmembrane protein that plays a pivotal role in growth factor signal transduction and epidermal growth factor receptor (EGFR) is a cell surface protein that binds to epidermal growth factor. Levels of the HER-2 and EGFR extracellular domains in serum were assessed by enzyme-linked immunosorbent assay (ELISA).|Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)|The pharmacodynamic population was defined as members of the ITT (as enrolled) population who had baseline samples submitted per Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approval and participant consent. Here, 'number analyzed' signifies participants evaluable at each time point for each arm respectively.|||ng/mL||Standard Deviation|Mean
2796310|NCT00548093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1|PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' signifies those participants who were evaluable for the measure.|||hours||Full Range|Median
2796311|NCT00548093|Secondary|Maximum Observed Plasma Concentration (Cmax)||0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1|PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' signifies those participants who were evaluable for the measure.|||nanogram per milliliter||Standard Deviation|Mean
2796312|NCT00548093|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]|The pharmacokinetic (PK) samples collected between 22-26 hours post dose on Day 1 of Cycle 1 were within the pre-specified time window for the 24-hour post dose sample and were used for calculation of AUC (0-24) on Day 1 of Cycle 1.|0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1|PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' (overall number of participants analyzed) signifies those participants who were evaluable for the measure.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2796313|NCT00548093|Secondary|Percent Probability of Overall Survival at Months 6 and 12|Probability of being alive at 6 and 12 months after the first dose of study medication.|Months 6, 12|As-enrolled population included all participants who were enrolled in the study.|||percent chance of being alive||95% Confidence Interval|Number
2796346|NCT00547521|Secondary|Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result).|Continuously from start of LTE period up to 7 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.|||participants|||Number
2796314|NCT00548093|Secondary|Percent Probability of Progression-free Survival (PFS) at Month 6|Probability of being event free (event defined as PD or death due to any cause) at 6 months after the first dose of study treatment. PFS was defined as the time from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date (if not reached, censored at the last known event-free date) minus first dosing date plus 1). Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria. PD was defined as at least a 20% increase in the sum of the longest diameters of the target lesions taking as a reference the smallest sum of the longest diameters recorded since treated started or the appearance of 1 or more new lesions.|Up to 6 months after the start of study medication|As-enrolled population included all participants who were enrolled in the study.|||percent chance of being event-free||95% Confidence Interval|Number
2796315|NCT00548093|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, end of every even-numbered cycle up to end of treatment (Day 936)|DR was calculated for the subgroup of participants from the response-evaluable population, with a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
2796316|NCT00548093|Secondary|Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology|BOR: best response recorded from treatment start until disease progression as per RECIST. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Baseline, end of every even-numbered cycle up to end of treatment (Day 936)|Response-evaluable population included all enrolled participants who received at least 1 dose of study treatment, with adequate baseline tumor assessment and at least 1 on-study tumor assessment after the first dosing.|||Participants|||Count of Participants
2796317|NCT00548093|Primary|Best Overall Response (BOR) in Participants With Adenocarcinoma Histology|BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Baseline, end of every even-numbered cycle up to end of treatment (Day 936)|Response-evaluable population included all enrolled participants who received at least 1 dose of study treatment, with adequate baseline tumor assessment and at least 1 on-study tumor assessment after the first dosing.|||Participants|||Count of Participants
2796318|NCT00548041|Primary|Feasibility of Rapid HIV Testing in Emergency Department|Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.|2 years||||participants|||Number
2796319|NCT00547911|Secondary|Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||BPM||Standard Error|Mean
2796320|NCT00547911|Secondary|Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||mmHg||Standard Error|Mean
2796321|NCT00547911|Secondary|Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||mmHg||Standard Error|Mean
2796322|NCT00547911|Primary|Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
2796323|NCT00547911|Primary|Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
2796605|NCT00546390|Primary|Myocardial Protection Against Ischemic Injury|High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.|72 hours post operatively||||pg/ml||Standard Deviation|Mean
2796325|NCT00547911|Primary|Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.|||nmol/L||Standard Error|Mean
2796326|NCT00547703|Secondary|Side Effects|To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia. Patients were asked about side effects on each office visit and ask to call for significant side effects.|8 weeks|||||||
2796327|NCT00547703|Secondary|QOLRAD Questionaire for Patients With Upper Abdominal Symptoms|Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia|8 weeks|||||||
2796328|NCT00547703|Primary|Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.|Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.|8 weeks|All patients who completed the 8 weeks of the study|||participants|||Number
2796329|NCT00547638|Other Pre-specified|Incidence of Any Other Anticipated or Unanticipated Adverse Events|Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering.|Day 30|Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed.|||Participants Experiencing at least 1 AE|||Number
2796330|NCT00547638|Other Pre-specified|Incidence of Skin Blistering at Day 14|The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test.|Day 14|Intent to treatment population was analyzed for the incidence of skin blistering at Day 14.|||Participants With Blistering at Day 14|||Number
2796331|NCT00547638|Other Pre-specified|The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30|Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test.|At Day 14 and Day 30|Intent to treat population was analyzed for subjects in each group with Total AIRE Score of 1-12 at Day 14 and Day 30. Analysis is performed on the proportion of subjects in each group with Total AIRE Scores greater than 0 versus those less or equal to 0 at each timepoint.|||Participants With AIRE Score >0|||Number
2796332|NCT00547638|Other Pre-specified|The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30|Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed.|Through Day 30|Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30.|||Participants|||Number
2796333|NCT00547638|Secondary|Cosmesis|The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.|30 days (±5 days)|Intent to Treat Population where good outcome for overall appearance. A p-value of 0.457 was determined following comparison by Fisher's Exact Test.|||Participants|||Number
2796334|NCT00547638|Primary|The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.|Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.|14 days (±2 days)|Intent to treat population results are presented.With respect to Measure Description it is defined as the number of participants in each group with successful wound-closure (approximation).|||Participants|||Number
2796335|NCT00547534|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.|Two years||||Lymphoma Subjects|||Number
2796336|NCT00547534|Secondary|Toxicity of Drug Combination in the Subjects||Two years||||Lymphoma Subjects|||Number
2796337|NCT00547534|Primary|Number of Participants With Progression Free Survival at 2 Years|To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.|Two years|Analysis was per protocol.|||Participants|||Number
2796338|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.|||participants|||Number
2797006|NCT00543803|Primary|Summary of Change From Baseline in Glucose to Last Value on Treatment|The change in Glucose from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
2796339|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study|Sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or <LLN); glucose (serum): <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.|||participants|||Number
2796340|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx; creatinine: >1.5 * pre-Rx.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.|||participants|||Number
2796341|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.|||participants|||Number
2796342|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.|||participants|||Number
2796343|NCT00547521|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.|||participants|||Number
2796344|NCT00547521|Secondary|Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup|Remission was defined as DAS 28-CRP < 2.6 and LDA was defined as DAS 28-CRP <= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.|Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.|||participants|||Number
2796345|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.|Baseline, Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.|||units on a scale||Standard Error|Mean
2796348|NCT00547521|Secondary|Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study|HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.|||units on a scale||95% Confidence Interval|Mean
2796349|NCT00547521|Secondary|Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE|DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.|Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.|||participants|||Number
2796350|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.|||participants|||Number
2796351|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.|||Units on a scale||95% Confidence Interval|Mean
2796352|NCT00547521|Secondary|Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study|The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.|Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.|||participants|||Number
2796353|NCT00547521|Secondary|Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study|Cmin serum abatacept concentration was obtained directly from the concentration-time data.|Days 1, 15, 29, 43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||microgram/mL||Full Range|Geometric Mean
2796354|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Vital Signs During the ST Study|Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.|At screening and on days 1,15,29,43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
2796355|NCT00547521|Secondary|Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study|Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
2796356|NCT00547521|Secondary|Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study|ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
2796357|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.|||participants|||Number
2796422|NCT00547118|Secondary|Calgary Depression Scale (CDS) Total Score|"The CDS total score is the addition of scores from items 1-9. Each item's scores range on a scale of 0=Absent to 3=Severe. The total score range is from 0-27. Higher total scores indicate a more severe depression rating."|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796358|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or < LLN); glucose (serum): <65 mg/dL or >220 mg/dL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.|||participants|||Number
2796359|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total)|MAs= laboratory measurements marked as abnormal: creatinine: >1.5 * pre-Rx; sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
2796360|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
2796361|NCT00547521|Secondary|Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.|||participants|||Number
2796362|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.|||participants|||Number
2796363|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the ST Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.|||participants|||Number
2796364|NCT00547521|Secondary|Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.|||participants|||Number
2796396|NCT00547248|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2796365|NCT00547521|Secondary|Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.|||participants|||Number
2796366|NCT00547521|Secondary|Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.|Baseline and Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.|||participants|||Number
2796367|NCT00547521|Secondary|Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.|||Units on a scale||95% Confidence Interval|Mean
2796368|NCT00547521|Secondary|Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day 113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.|||Units on a scale||95% Confidence Interval|Mean
2796369|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.|Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.|||participants|||Number
2796370|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Baseline and day 15, 29, 43, 57, 85 and 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.||||||
2796371|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Baseline and on day 15, 29, 43, 57, 85 and 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.||||||
2796372|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.||||||
2796421|NCT00547157|Primary|Local Regional Control Rate at 2 Years|Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).|from study day 1 to 2 years|Efficacy Analysis Set|||Proportion of Participants||95% Confidence Interval|Number
2796373|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.||||||
2796374|NCT00547521|Primary|Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.|||participants|||Number
2796375|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.|||participants|||Number
2796376|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.|||Units on a scale||95% Confidence Interval|Mean
2796377|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.|||participants|||Number
2796378|NCT00547456|Primary|Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.||4 weeks|The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed.||||||
2796379|NCT00547378|Secondary|All Implanted Cohort: Infection Rate Associated With the Tined Lead|To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.|5 years|This objective was analyzed in the all implanted cohort.|||Cumulative probability at 5 years||95% Confidence Interval|Number
2796380|NCT00547378|Secondary|All Implanted Cohort: Tined Lead Migration Rate|To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.|5 years|This objective was analyzed in the all implanted cohort.|||Cumulative probability at 5 years||95% Confidence Interval|Number
2796381|NCT00547378|Primary|All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery|"To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33.~Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest."|5 years|This objective was analyzed in the all implanted cohort.|||Cumulative probability at 5 years||95% Confidence Interval|Number
2796382|NCT00547378|Primary|Randomized Cohort: OAB Therapeutic Response|"To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as:~at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or~at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (<8 voids/day) for subjects with urgency-frequency at baseline."|6 months|Intent-to-Treat (ITT): an analysis that includes all randomized subjects. This was analysis in the randomized cohort.|||percentage of participants with response|||Number
2796423|NCT00547118|Secondary|Clinical Global Impression (CGI)|The global improvement score can range from 1-7, with higher scores indicating worse total improvement clinically.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796383|NCT00547365|Primary|Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)|Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.|Up to 1 year|Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).|||participants with positive response|||Number
2796384|NCT00547365|Primary|Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV.||Up to 1 year|All patients who had at least one infusion of human immune globulin intravenous.|||events|||Number
2796385|NCT00547300|Secondary|Pulse Rate||Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)|Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study.||||||
2796386|NCT00547300|Secondary|Peripheral Blood Pressure (BP)||Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)|Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study.||||||
2796387|NCT00547300|Primary|Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score|The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).|Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)|Formal analysis of the primary endpoint was not conducted in this abbreviated study as the study was terminated before visit 10 was reached.||||||
2796388|NCT00547248|Secondary|Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)|Vaccine response for anti-BPT, defined as the appearance of antibodies in subjects seronegative at pre-vaccination, or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination.|One month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2796389|NCT00547248|Secondary|Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off|The cut-off for the assay was 8.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2796390|NCT00547248|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off|The cut-off for the assay was 10 mIU/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2796391|NCT00547248|Secondary|Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off|The cut-off for the assay was 1.0 μg/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796392|NCT00547248|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off|The cut-off for the assay was 0.15 μg/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796393|NCT00547248|Secondary|Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off|The cut-off for the assay was 0.1 milli-international units per milliliter (mIU/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796394|NCT00547248|Secondary|Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off|The cut-off for the assay was 15 EL.U/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2796395|NCT00547248|Secondary|Anti-polio Type 1, 2 and 3 Antibody Titers|Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥ 8.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2797007|NCT00543803|Primary|Summary of Change From Baseline in Triglycerides to Last Value on Treatment|The change in triglycerides from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
2796397|NCT00547248|Secondary|Anti-Bordetella Pertussis (BPT) Antibody Concentrations|Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2796398|NCT00547248|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations|Seroprotection status, defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||μg/mL||95% Confidence Interval|Geometric Mean
2796399|NCT00547248|Secondary|Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||IU/mL||95% Confidence Interval|Geometric Mean
2796400|NCT00547248|Secondary|Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off|The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796401|NCT00547248|Secondary|Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off|The cut-off for the assay was 8.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796402|NCT00547248|Secondary|Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off|The cut-of for the assay was 0.05 μg/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796403|NCT00547248|Secondary|Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off|The cut-off for the assay was 8.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796404|NCT00547248|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off|The cut-off of the assay was 0.05 μg/mL.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796405|NCT00547248|Secondary|Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2796406|NCT00547248|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||μg/mL||95% Confidence Interval|Geometric Mean
2796407|NCT00547248|Secondary|Antibody Concentrations to Protein D (Anti-PD)|Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||EL.U/mL||95% Confidence Interval|Geometric Mean
2796424|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Avolition|SANS Avolition score. Scores can range from 0-5, with higher scores indicating more severe avolition.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796408|NCT00547248|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Titers||95% Confidence Interval|Geometric Mean
2796409|NCT00547248|Secondary|Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling.|||μg/mL||95% Confidence Interval|Geometric Mean
2796410|NCT00547248|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off|The cut-off was 0.20 microgram per milliliter (μg/mL).|Prior to (Month 0) and one month after booster vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sampling taken before the administration of the study booster dose (pre-booster blood sampling).|||Participants|||Count of Participants
2796411|NCT00547248|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the active phase of the study (Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2796412|NCT00547248|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within the 31-day (Days 0-30) period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2796413|NCT00547248|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature greater than or equal to (≥) 38.0°C), irritability, and loss of appetite.Any was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) >40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all."|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2796414|NCT00547248|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed included pain, redness and swelling. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm)."|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2796415|NCT00547248|Primary|Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off|Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheets filled in. For the purpose of the analysis, subjects were pooled into two groups, according to the booster vaccine they have received (Synflorix™ or Prevenar™).|||Participants|||Count of Participants
2796416|NCT00547157|Secondary|CRR by 6 Months - Central|CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.|From randomization till 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.|||Proportion of Participants||95% Confidence Interval|Number
2796417|NCT00547157|Secondary|ORR by 6 Months - Central|ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.|From randomization to 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.|||Proporation of Participants||95% Confidence Interval|Number
2796418|NCT00547157|Secondary|Overall Survival|Time from first dose date to death|maximum follow up time 46.2 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
2796419|NCT00547157|Secondary|Progression-free Survival|Time from first dose date till disease progression or death|maximum follow up time 46.2 months|Efficacy analysis set|||months||95% Confidence Interval|Median
2796420|NCT00547157|Secondary|Duration of Local Regional Control|Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)|maximum follow up time 46.2 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
2796426|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Blunted Affect|SANS Global Rating of Affective Flattening. Scores can range from 0-5, with higher scores indicating more severe blunted affect.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796427|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) - Anhedonia|SANS Global Anhedonia score. Scores can range from 0-5, with higher scores indicating more severe anhedonia.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796428|NCT00547118|Secondary|Schedule for Assessment of Negative Symptoms (SANS) Total Score|SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796429|NCT00547118|Primary|N-Back Neurocognitive Task: 2-back Condition|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
2796430|NCT00547118|Primary|N-Back Neurocognitive Task: 1-back Condition|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
2796431|NCT00547118|Primary|N-Back Neurocognitive Task: 0-back Condition|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
2796432|NCT00547118|Primary|The Iowa Gambling Task (IGT)|The Iowa Gambling Task (IGT) is a computer-administered cognitive test that assesses risk preferences by simulating real-life decision making using uncertainty, rewards, and penalties. In the task, players are given four decks of cards and an endowment of fake money (e.g., $2000). Players are instructed to select cards one at a time and try to lose the least amount of money and win the most. The outcome measure was the number of rewarded minus punished card choices. Task has a maximum of 100 trials. The net score is the difference between the number of choices from advantageous decks verses disadvantageous decks. Higher scores are better and can range from -50 to +50.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
2796433|NCT00547118|Primary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Baseline (Week 0) and end of study (Week 16)|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).|||units on a scale||Standard Deviation|Mean
2796434|NCT00547118|Primary|Brief Psychiatric Rating Scale (BPRS) Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796435|NCT00547118|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Baseline (Week 0) and end of study (Week 16)|Because of early study termination, 2 participants on rimonabant and 3 on placebo were withdrawn before completion.|||units on a scale||Standard Deviation|Mean
2796448|NCT00546910|Secondary|Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2796436|NCT00547105|Secondary|Progression-free Survival|"For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy."|up to 5 years||||months||Full Range|Median
2796437|NCT00547105|Secondary|Out-of-field Disease Progression|Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months|9 months|The other three patients died or had not otherwise reached this window for evaluation.|||Participants|||Count of Participants
2796438|NCT00547105|Secondary|Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy|To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent)|3 years||||days||Full Range|Median
2796439|NCT00547105|Secondary|Overall Survival|evaluate overall survival after SBRT in combination with erlotinib|up to 5 years||||months||Full Range|Median
2796440|NCT00547105|Secondary|Number of Participants Without Serious Adverse Events Related to Radiation|Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events|3 years||||Participants|||Count of Participants
2796441|NCT00547105|Secondary|In-field Local Control|In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity.|9 months|21 out of 24 patients were evaluable with baseline and minimum 3-month follow-up CT based imaging. The other three patients died or had not otherwise reached this window for evaluation.|||lesions treated with SBRT|lesions treated with SBRT||Count of Units
2796442|NCT00547105|Primary|6 Month Progression-Free Survival|"For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy."|6 months|Twenty-four patients with stage IV Non-small-Cell Lung Caner with six or fewer sites of disease after progressing through first-line or subsequent systemic therapy were enrolled on the study.|||percentage of participants|||Number
2796443|NCT00546910|Primary|Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
2796444|NCT00546910|Primary|Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
2796445|NCT00546910|Primary|Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
2796446|NCT00546910|Secondary|Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8|Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2796447|NCT00546910|Secondary|Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8|CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2796449|NCT00546910|Primary|Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8|Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks (W8)|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.|||Q-scores||Standard Deviation|Mean
2796450|NCT00546897|Secondary|Plasma Proteins Via Proteomics|Proteomic analysis will be performed within the Siteman Cancer Center proteomics core on pre- and post-treatment plasma samples. This pilot proteomic study will identify candidate proteins of interest with altered expression after treatment with lenalidomide. This approach will provide an unbiased method to assess global changes in serum proteins following lenalidomide therapy.|Pre and post treatment|This outcome was not analyzed for either Cohort due to sample collection.||||||
2796451|NCT00546897|Secondary|Gene Expression Profiles of Bone Marrow and Peripheral Blood|RNA will be made from total bone marrow cells for labeling and evaluations by RNA profiling. Cellular RNA and corresponding biotinylated cRNA targets will be prepared and hybridized with Affymetrix GeneChip® microarrays within the Multiplexed Gene Analysis SCC Core (Dr. Mark Watson, Director). Microarray data (and eventually corresponding gene sequence data) will be integrated an analyzed with state-of-the-art software packages. The pre- and post-treatment RNA profiling studies will be used as a discovery tool. Patterns of gene expression before and after lenalidomide therapy will be compared within each patient's sample to identify genes with altered expression after lenalidomide therapy. In addition, supervised algorithms will be sued to identify genes that can potentially predict clinical outcome and response to lenalidomide therapy.|Pre and post treatment|This outcome measure was not analyzed for either Cohort due to sample collection.||||||
2796452|NCT00546897|Secondary|Changes in NK Cell Number and Function|Peripheral blood mononuclear cells (PBMC) will be viably cryopreserved from patients at baseline (pre-therapy, newly diagnosed AML), during lenalidomide therapy, and posttherapy. Following sample collection, PBMC will be thawed, and flow cytometry will be performed to assess NK cell number (CD56+CD3-), subsets, and phenotype utilizing the Siteman Cancer Center Flow Cytometry / Cell Sorting Core. In addition, NK cell function will be assessed in flow based killing assays using PBMC (containing NK cells) as effectors and NK sensitive cell lines (K562) and/or autologous leukemic blasts as target cells. Thus, analyzing these parameters in patients before, during, and after therapy will provide a comprehensive evaluation of the ability of lenalidomide to modulate NK cells in patients in vivo.|Baseline, during therapy, and posttherapy|This outcome was not analyzed for either Cohort due to number of samples collected.||||||
2796453|NCT00546897|Secondary|Duration of CR for Complete Responders|Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence|2 years|Participants in Cohort 1 were not analyzed for duration of remission because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||Full Range|Median
2796454|NCT00546897|Secondary|Relapse Free Survival (RFS) for Complete Responders|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|2 years|Participants in Cohort 1 were not analyzed for relapse free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||95% Confidence Interval|Median
2796455|NCT00546897|Secondary|Progression-free Survival|Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is.|2 years|Participants in Cohort 1 were not analyzed for progression-free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||95% Confidence Interval|Median
2796456|NCT00546897|Secondary|Event Free Survival (EFS)|Event free survival: Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|2 years|Event free survival was not analyzed. Progression free survival was analyzed instead.||||||
2796457|NCT00546897|Secondary|Overall Survival (OS)|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|2 years|Participants in Cohort 1 were not analyzed for overall survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.|||months||95% Confidence Interval|Median
2796458|NCT00546897|Secondary|Partial Remission Rate (PR)|Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796459|NCT00546897|Secondary|CR With Complete Blood Counts (CRi) Rate|CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796460|NCT00546897|Secondary|Cytogenetics CR Rate (CRc)|Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796461|NCT00546897|Secondary|Morphologic Complete Remission Rate (CRm)|CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796462|NCT00546897|Secondary|Morphologic Leukemia Free State|Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796463|NCT00546897|Secondary|Response Rate (RR)|"RR = as patients obtaining any response (CRm + CRc +CRi + PR).~CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Partial remission (PR): Requires"|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796464|NCT00546897|Secondary|Safety and Tolerability (Removal From Study Due to Adverse Events)|Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting|4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]||||participants|||Number
2796465|NCT00546897|Primary|Complete Remission Rate (CRm + CRi + CRc)|"CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells)."|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."|||participants|||Number
2796466|NCT00546884|Primary|Completion of Advance Directive|Completing an advance directive for the individuals health care when they are not able to direct it themselves|21 months||||Participants|||Count of Participants
2796467|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
2796468|NCT00546871|Primary|Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)|||Percentage of Infusions|Infusions|95% Confidence Interval|Number
2796469|NCT00546871|Primary|Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)|||Percentage of Infusions|Infusions|95% Confidence Interval|Number
2796470|NCT00546871|Primary|Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)|||Percentage of Infusions|Infusions|95% Confidence Interval|Number
2796677|NCT00546078|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.|||Participants|||Count of Participants
2796471|NCT00546871|Primary|Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)|||Percentage of Participants|||Number
2796472|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
2796473|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
2796474|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Percentage of infusions|Infusions||Number
2796475|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Related to the Study Drug||Throughout the study period (1 year and 9 months)|All participants who received any study drug|||Percentage of infusions|Infusions||Number
2796476|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts|||AEs per infusion|||Number
2796477|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts|||Adverse events|||Number
2796478|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts|||AEs per infusion|||Number
2796479|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts|||Adverse events|||Number
2796480|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts|||AEs per infusion|||Number
2796481|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts|||Adverse events|||Number
2796482|NCT00546871|Primary|Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)|||Percentage of Participants|||Number
2796483|NCT00546871|Secondary|Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||Proportion of participants|||Number
2796484|NCT00546871|Secondary|Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L)|"Frequency of Dose Adjustments Based on IgG Trough Levels <4.5 g/L IgG, if Any, for Each Study Part.~Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set."|Throughout the study period (1 year and 9 months)|All participants who received any study drug|||ratio|||Number
2796485|NCT00546871|Secondary|AEs Deemed/Judged to be Related by the Investigator|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.|Throughout the study period (1 year and 9 months)|All participants who received any study drug|||AEs per infusion|Infusions||Number
2796486|NCT00546871|Secondary|Rate of Temporally Associated AEs Per Infusion|"Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion (temporally associated) divided by the total number of infusions."|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug|||AEs per infusion|Infusions||Number
2796487|NCT00546871|Secondary|Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)|Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.|Throughout the study, 1 year and 9 months|Full Safety Data Set (All study participants who received any infusions)|||Estimated infections/year|||Number
2796488|NCT00546871|Secondary|Annual Infection Rates During Treatment|Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.|Throughout the study, 1 year and 9 months|Full safety data set (all participants who received any study drug)|||Estimated infections per year||95% Confidence Interval|Mean
2796489|NCT00546871|Secondary|Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level|Antibody Titers That Were Below or Above the Protective Titer Level of >1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All study participants|||Antibody titers|Antibody titers||Number
2796490|NCT00546871|Secondary|Trough Levels of Antibody to Tetanus In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results|||IU/mL||95% Confidence Interval|Median
2796491|NCT00546871|Primary|Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)|||Percentage of Participants|||Number
2796492|NCT00546871|Secondary|Trough Levels of Antibody to Hepatitis B in All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results|||mIU/mL||95% Confidence Interval|Median
2796493|NCT00546871|Secondary|Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results|||µg/mL||95% Confidence Interval|Median
2796494|NCT00546871|Secondary|Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older|"Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks)~Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks)~Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks)~Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants who received any study drug), 12 Years and Older|||g/L||95% Confidence Interval|Median
2796495|NCT00546871|Secondary|Study Part 3B: Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||mL/kg/day||95% Confidence Interval|Median
2796496|NCT00546871|Secondary|Study Part 3B: Area Under the Curve (AUC)|The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g*days/L||95% Confidence Interval|Median
2796497|NCT00546871|Secondary|Study Part 3B: Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
2796498|NCT00546871|Secondary|Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||days||95% Confidence Interval|Median
2796499|NCT00546871|Secondary|Study Part 3B: Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
2796500|NCT00546871|Secondary|Study Part 2 (SC): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||mL/kg/day||95% Confidence Interval|Median
2796501|NCT00546871|Secondary|Study Part 2 (SC): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
2796502|NCT00546871|Secondary|Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||days||95% Confidence Interval|Median
2796503|NCT00546871|Secondary|Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"|||g/L||95% Confidence Interval|Median
2796504|NCT00546871|Secondary|Study Part 1 (IV): Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||days||95% Confidence Interval|Median
2796505|NCT00546871|Secondary|Study Part 1 (IV): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||mL/kg/day||95% Confidence Interval|Median
2796506|NCT00546871|Secondary|Study Part 1 (IV): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||g/L||95% Confidence Interval|Median
2796507|NCT00546871|Secondary|Study Part 1 (IV): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"|||g/L||95% Confidence Interval|Median
2796508|NCT00546871|Primary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.|"Administration of IGIV, 10%:~Part 1 = IV administration (IV)~Parts 2, 3a, 3b = SC administration (SC)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants, aged 2 to <12 years who received any study drug)|||g/L||95% Confidence Interval|Median
2796509|NCT00546871|Primary|Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage|Expressed as (AUC_SC/AUC_IV) * 100|Week 12 (IV) and week 32 or 33 (SC)|Participants, ≥12 years, with PK data in terms of AUC[0-τ]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b|||percent||90% Confidence Interval|Number
2796510|NCT00546819|Secondary|Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.|The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.|||Ratio||95% Confidence Interval|Mean
2796511|NCT00546819|Secondary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination|The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.|||gpELISA units/mL||95% Confidence Interval|Mean
2796629|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.|0 = no surface pain and 10 = most intense surface pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796512|NCT00546819|Primary|Number of Participants With Serious Adverse Events (SAE)|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Up to 182 days postvaccination|"All participants who were vaccinated and had any safety~follow-up were included in the safety analysis."|||Participants|||Number
2796513|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||IU/L||Standard Deviation|Mean
2796514|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||IU/L||Standard Deviation|Mean
2796515|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||umol/L||Standard Deviation|Mean
2796516|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mg/L||Standard Deviation|Mean
2796517|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||umol/L||Standard Deviation|Mean
2796518|NCT00546754|Primary|Change in Diastolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
2796519|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||umol/L||Standard Deviation|Mean
2796520|NCT00546754|Secondary|Time to Achieve Target Blood Pressure|Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)|12 weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||Days||Standard Deviation|Mean
2796521|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 12|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12|12 Weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||Patients|||Number
2796522|NCT00546754|Primary|Change in Systolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
2796523|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6|Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||Patients|||Number
2796524|NCT00546754|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
2796525|NCT00546754|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively|||mm Hg||Standard Deviation|Mean
2796526|NCT00546728|Primary|Change in Reactive Hyperemic Index Over the 3-month Treatment Period|Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.|Change from baseline to 3 months|All completers were included in the analysis|||ratio||Standard Deviation|Mean
2796527|NCT00546715|Secondary|Change From Baseline in Blood Pressure to Day 7 or Discharge|Changes in blood pressure from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement.|Baseline (Day 1), Day 7 or Discharge||||mmHg||Standard Deviation|Mean
2796630|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.|0 = not unpleasant and 10 = most unpleasant sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796528|NCT00546715|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge|The ECG was recorded after the participant was in a supine position for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. QTc was defined as corrected QT interval at a heart rate of 60 bpm. QTc was estimated using Bazett's formula and Fredericia's formula.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.|||msec||Standard Deviation|Mean
2796529|NCT00546715|Secondary|Change From Baseline in Heart Rate to Day 7 or Discharge|Changes in heart rate from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The normal heart rate lies between 60-90 beats per minute (bpm), below 60 bpm and above 90 bpm were considered as bradycardia and tachycardia, respectively.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.|||bpm||Standard Deviation|Mean
2796530|NCT00546715|Secondary|Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline|Participants were assessed for time to reach maximum decrease in log10 hepatitis C virus RNA level. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the PD population defined as participants who received at least one dose of study medication with available valid data.|||hours||Standard Deviation|Mean
2796531|NCT00546715|Secondary|Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Positive value indicated reduction from baseline in HCV RNA while negative value indicated an increase from baseline in HCV RNA. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the pharmacodynamic (PD) population defined as participants who received at least one dose of study medication with available valid data.|||log IU/mL||Standard Deviation|Mean
2796532|NCT00546715|Secondary|Apparent Total Body Clearance (CLT/F)|Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2796533|NCT00546715|Secondary|Plasma Half-life (T-half)|Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||hours||Standard Deviation|Mean
2796534|NCT00546715|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||hours||Full Range|Median
2796535|NCT00546715|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2796536|NCT00546715|Secondary|Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. C-12 and C-24 were defined as observed plasma concentration of daclatasvir at 12 hours and 24 hours, respectively. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the pharmacokinetic (PK) set population defined as all participants who received at least single dose of daclatasvir with available valid data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2796537|NCT00546715|Primary|Number of Participants With Marked Abnormalities in Laboratory Findings|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*pre-treatment value, Leukocytes (low) as <0.9*lower limit of normal, Aspartate Aminotransferase (high) as >1.25*upper limit of normal, Creatinine (high) as >1.33*pre-treatment value, Bicarbonate (high) as >1.2*upper limit of normal, Total Protein (high) as >1.1*upper limit of normal, Creatinine Kinase (high) as >1.5*upper limit of normal, Blood in Urine (high) as ≥ 2*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.|Day 1 up to Day 7|The analysis was performed in the safety population.|||participants|||Number
2796549|NCT00546637|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12|OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796538|NCT00546715|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings|Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.|Day 1 up to Day 7 or Discharge|The analysis was performed in the safety population.|||participants|||Number
2796539|NCT00546715|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding) or disease which either occurs during study, whether or not related to the study drug. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs|Analysis was performed in safety population defined as all participants who received any study drug treatment.|||participants|||Number
2796540|NCT00546637|Secondary|Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)|Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.|||participants|||Number
2796541|NCT00546637|Secondary|Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)|Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.|||participants|||Number
2796542|NCT00546637|Secondary|Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12|Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis.|||ml/sec||Full Range|Median
2796543|NCT00546637|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12|Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.|Baseline, Week 4, 8 and 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis.|||ml||Full Range|Median
2796544|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)|The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
2796545|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)|The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
2796546|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)|The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
2796547|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)|The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796548|NCT00546637|Secondary|Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12|HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796550|NCT00546637|Secondary|Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).|||participants|||Number
2796551|NCT00546637|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.|||participants|||Number
2796552|NCT00546637|Secondary|Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).|||participants|||Number
2796553|NCT00546637|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.|||participants|||Number
2796554|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 12|FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796555|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4|FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796556|NCT00546637|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796557|NCT00546637|Secondary|Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796558|NCT00546637|Secondary|Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on scale||Standard Error|Least Squares Mean
2796559|NCT00546637|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
2796560|NCT00546637|Secondary|Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12|The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis.|||USS Sum rating per 24 hours||Standard Error|Least Squares Mean
2796561|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
2796562|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of episodes||Standard Error|Least Squares Mean
2796563|NCT00546637|Secondary|Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
2796564|NCT00546637|Secondary|Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of episodes||Full Range|Median
2796565|NCT00546637|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12|UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 - Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
2796566|NCT00546637|Secondary|Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and Week 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of episodes||Full Range|Median
2796567|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 - Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
2796568|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of micturitions||Standard Error|Least Squares Mean
2796569|NCT00546637|Secondary|Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 - Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
2796570|NCT00546637|Secondary|Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||number of micturitions||Standard Error|Least Squares Mean
2796571|NCT00546637|Secondary|Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|"Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as:~100* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline"|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.|||percent change||Full Range|Median
2796596|NCT00546481|Secondary|Mean Change From Baseline in Hemoglobin Concentration at Week 24|Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value|From Baseline (Day 1) to Week 24|The Intent-to-Treat population included all randomized participants.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2796572|NCT00546637|Secondary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis.|||number of episodes||Standard Error|Least Squares Mean
2796573|NCT00546637|Primary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.|||number of episodes||Standard Error|Least Squares Mean
2796574|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796575|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796576|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796577|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796578|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796597|NCT00546481|Primary|Percentage of Participants Who Achieved Hemoglobin Response up to Week 24|Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented|Up to Week 24|The Intent-to-Treat population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2796598|NCT00546429|Secondary|Merle d'Aubigne and Postel||4 weeks, 3, 6 and 12 months|||||||
2796579|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796580|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796581|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796582|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796583|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0|Safety population is all participants who receive at least 1 dose of study vaccine. N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Vax 1). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2796584|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2796585|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titers||95% Confidence Interval|Geometric Mean
2796599|NCT00546429|Secondary|SF-12||4 weeks, 3, 6 and 12 months|||||||
2796600|NCT00546429|Secondary|Six Item Screener and Ambulatory Status||4 weeks, 3, 6 and 12 months|||||||
2796601|NCT00546429|Secondary|Medical Imaging||4 weeks, 3, 6 and 12 months|||||||
2796602|NCT00546429|Secondary|Lower Extremity Measure (LEM)||4 weeks, 3, 6 and 12 months|||||||
2800039|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
2796586|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2796587|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2796588|NCT00546572|Primary|Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.|Baseline, 1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate antibody titer to the given serotype.|||observed percentage of participants||95% Confidence Interval|Number
2796589|NCT00546572|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate OPA antibody titer to the given serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2796590|NCT00546481|Secondary|Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24|Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|Up to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.|||Number of participants|||Number
2796591|NCT00546481|Secondary|Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24|Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.|||Beats per minute for heart rate||Standard Deviation|Mean
2796592|NCT00546481|Secondary|Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24|Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.|||millimeters of mercury||Standard Deviation|Mean
2796593|NCT00546481|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 49|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|||Number of participants|||Number
2796594|NCT00546481|Secondary|Number of Participants Who Received Red Blood Cells Transfusions up to Week 49|The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)|Up to Week 49|The Intent-to-Treat Population included all randomized participants.|||Number of participants|||Number
2796595|NCT00546481|Secondary|Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24|Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.|Up to Week 24|The Intent-to-Treat population included all randomized participants.|||Days||95% Confidence Interval|Median
2807080|NCT00471276|Other Pre-specified|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|Baseline up to 1 year|ITT|||Percentage of participants||95% Confidence Interval|Number
2796606|NCT00546377|Primary|Maximum Tolerated Dose (MTD) of Mitoxantrone|The MTD is defined as the highest dose studied for which the incidence of DLT is less than 33%. In the phase I portion of the trial, cohorts of 3-6 pts will receive pentostatin, cyclophosphamide and rituximab along with one of three potential dose levels of mitoxantrone. The following dose escalation scheme will be followed: If none of the initial three pts in a cohort experience a dose-limiting toxicity (grade 4 infection, or grade ≥ 3 non-hematologic toxicity that persists for 7 days or more) then a new cohort of three pts will be treated at the next higher dose level. If one of the three pts in a cohort experiences DLT, then up to three additional pts will be treated at the same dose level. If two or more pts in a cohort experience DLT, then the maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. The previous dose level will be considered as the MTD.|2 years||||mg/m2|||Number
2796607|NCT00546377|Primary|Overall Response|Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|3 years||||participants|||Number
2796608|NCT00546364|Secondary|Median Number of Treatment Cycles|The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.|Day 1 to end of Cycle 18, maximum (54 weeks)|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Treatment cycles||Full Range|Median
2796609|NCT00546364|Primary|Percentage of Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.|||Percentage of patients|||Number
2796610|NCT00546364|Secondary|Duration of Response|Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.|Baseline (date of randomization) to date CR or PR criteria first met|This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.||||||
2796611|NCT00546364|Secondary|Time to Progression|Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.|Baseline to date progressive disease reported|This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.||||||
2796612|NCT00546364|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results|ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Participants|||Number
2796613|NCT00546364|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Participants|||Number
2796614|NCT00546364|Secondary|Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.|Baseline to end of Cycle 1 (21 days), continuously|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.|||Participants|||Number
2796615|NCT00546364|Secondary|Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|Baseline to 6 weeks (end of Cycle 2)|All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|||Percentage of NTN Participants|||Number
2796616|NCT00546364|Secondary|Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).|Baseline to 6 weeks (end of Cycle 2)|All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|||Percentage of TN Participants|||Number
2796617|NCT00546364|Primary|Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.|||Participants|||Number
2796618|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.~Data was not available for 69 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796619|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.~Data was not available for 33 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796620|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.~Data was not available for 69 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796621|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.~Data was not available for 33 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796622|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.|0 = no interference with activity and 10 = worst possible interference with activity.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796623|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Baseline.|0 = no interference with activity and 10 = worst possible interference with activity.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796624|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796625|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796626|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.|0 = not sensitive and 10 = most sensitive sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796627|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.|0 = not itchy and 10 = most itchy sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796628|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.|0 = no deep pain and 10 = most intense deep pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796631|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.|0 = not dull and 10 = most dull sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796632|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.|0 = not cold and 10 = the coldest sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796633|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.|0 = not hot and 10 = the most hot sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796634|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.|0 = not sharp and 10 = most sharp sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796635|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.|0 = no pain and 10 = most intense pain sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796636|NCT00546351|Secondary|Patient's Global Impression of Change (PGIC) at Last Visit.|"The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).~Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse)."|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis.~Data was not available for 70 subjects at the time of this measurement."|||percentage of participants|||Number
2796637|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.|On VAS 0 mm = no pain and 100 mm = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis.~Data was not available for 407 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796638|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.|Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis.~Data was not available for 408 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796639|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796640|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."|||units on a scale||Standard Deviation|Mean
2796641|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|"A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:~Is fatal~Is life-threatening~Results in persistent or significant disability/incapacity~Requires inpatient hospitalization~Prolongs existing inpatient hospitalization~Is a congenital anomaly/birth defect~Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above"|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).|||participants|||Number
2796642|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).|||participants|||Number
2796643|NCT00546273|Primary|Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression|haematological and biochemical laboratory tests|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156|All the participants of the study were analyzed for this specific outcome measure.|||number of abnormalities|||Number
2796644|NCT00546273|Primary|Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events||during the whole study||2008-11-30|11/2008||||
2796645|NCT00546273|Secondary|Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested|Immunological assays are performed at all timepoints to determine vaccine immunogenicity|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156||2008-11-30|11/2008||||
2796646|NCT00546273|Primary|VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point||at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56||2008-11-30|11/2008||||
2796647|NCT00546260|Secondary|Percentage ST-segment Resolution Prior to PCI|The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.|Before primary PCI|Per protocol.|||Percentage of ST-segment Resolution||Inter-Quartile Range|Median
2796648|NCT00546260|Secondary|Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI|This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.|Time for contrast to reach a standardized distal coronary landmark in the culprit vessel|Per protocol|||frames per minute||Inter-Quartile Range|Median
2796649|NCT00546260|Primary|Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days|"TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.~TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10-15%.~GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.~GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.~Stroke:New focal neurologic deficit that does not resolve within 24 hours."|30 days|"All subjects receiving some component of study drug (the as-treated population)"|||Participants|||Number
2796650|NCT00546156|Secondary|Decrease in Interstitial Fluid Pressure.|To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure|3 years|This represents the number of patients with paired IFP measurements from day 0 and day 14|||mm Hg||Inter-Quartile Range|Median
2796651|NCT00546156|Primary|Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.|Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery|3 Years|Participants who met all study eligibility criteria and signed informed consent.|||percentage of participants|||Number
2796652|NCT00546117|Secondary|Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire|Questions regarding reflux symptoms, created and evaluated by Nelson et al, Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey, Arch Pediatr Adolesc Med 2000;154;150-154. This study used the GER3-9P version for children aged 3-9 years. Results are reported as number reporting at least one specific symptom in the past week, maximum 7 symptoms.|2 months||||Participants|||Count of Participants
2796653|NCT00546117|Secondary|Number of Participants With Normal Type A Tympanometry|"Tympanometry of both ears, coded by Jerger classification (Type A, normal; type B, flat; Type C; negative pressure).~This is a standard test of middle ear status as performed by audiologists. Please refer to the reference for more information: Kileny & Zwolan, Diagnostic Audiology, chapter 133, Cummings Otolaryngology-Head and Neck Surgery, Elsevier/Saunders, 2015."|2 months||||Participants|||Count of Participants
2796654|NCT00546117|Secondary|Acoustic Reflectometry: Level of Risk as Defined by Manufacturer|Spectral gradient acoustic reflectometry is a noninvasive, non-audible acoustic wave used to help detect middle ear fluid. The manufacturer recommends interpretation of the angle result as: <49°, high risk of middle ear effusion (level 5); 49-59°, moderate-high risk (level 4); 60-69°, moderate risk (level 3); 70-95°, low-moderate risk (level 2) and >95°, low risk (level 1).|2 months||||level of risk||Full Range|Mean
2796655|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar||2 months||||participants|||Number
2796656|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear||2 months||||participants|||Number
2796657|NCT00546104|Secondary|To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption|Not assessed secondary to limited number of subjects.|not assessed|||||||
2796658|NCT00546104|Secondary|To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression.|Spearman's correlation between the change in SRC signature from baseline to 4 weeks and time to progression|Baseline Src measure to first progression|11 patients had both change in Src level and progression time intervals|||correlation coefficient|||Number
2796659|NCT00546104|Secondary|Correlate SRC Dysregulation Results With Response to Dasatinib Therapy|Since all patients progressed there is no comparison to between responders and non-responders.|16 weeks|20 patients with baseline and 4 week Src measures. 11 patients came off due to screen failure, toxicity or progression before 4 week biopsy.|||percentage change in p-SRC||95% Confidence Interval|Mean
2796660|NCT00546104|Secondary|Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response)|For the 20 patients with evaluable biopsies at baseline and week 4, the median relative change from baseline in tissue biomarker levels of phospho-Src (p-Src)|4 weeks|Twenty patients with evaluable biopsies at baseline and 4 week follow-up|||percentage of change in p-SRC||Inter-Quartile Range|Median
2796661|NCT00546104|Secondary|To Measure Response to Protocol Therapy Per RECIST Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as a reference the smallest sum longest diameter recorded since treatment started, or the appearance of one or more new lesions.~RECIST 1.0 Overall response:~Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD)~CR= CR+CR and No new lesions PR= CR+SD; PR+SD and no new lesions SD= SD+SD and no new lesions PD= PD+any new lesions"|16 weeks|Proportion with Best Response of Stable Disease|||percentage of participants|||Number
2796662|NCT00546104|Primary|Estimation of the Proportion of Progression-free Patients at 16 Wks.|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate.~Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first."|16 weeks|31 patients on this trial, 1 patient was found to have disease progression at 16-weeks, 16 patients had disease progression prior to 16 weeks, 8 patients were taken off-treatment due to toxicity, and 6 patients voluntarily withdrew from treatment. These latter two groups of patients were censored in the analysis of Progression Free Survival.|||percentage of participants||95% Confidence Interval|Number
2796663|NCT00546078|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 18||||Participants|||Count of Participants
2796664|NCT00546078|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 18||||Participants|||Count of Participants
2796665|NCT00546078|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|From Day 0 up to Month 18|Analysis was performed on those subjects reporting pregnancy during the study period.|||Participants|||Count of Participants
2796666|NCT00546078|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed."|Within 30 days of vaccination||||Participants|||Count of Participants
2796667|NCT00546078|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.~Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days of vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.|||Participants|||Count of Participants
2796668|NCT00546078|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days after vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.|||Participants|||Count of Participants
2796669|NCT00546078|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).~Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2796670|NCT00546078|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples|"Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.~Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.|||Participants|||Count of Participants
2796671|NCT00546078|Secondary|Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.~A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.|||Participants|||Count of Participants
2796672|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.|||Participants|||Count of Participants
2796673|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.|||Participants|||Count of Participants
2796674|NCT00546078|Secondary|Anti-HPV-31 and Anti-HPV-45 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Day 7, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity|||titer||95% Confidence Interval|Geometric Mean
2796675|NCT00546078|Secondary|Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL||Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.|||Participants|||Count of Participants
2796676|NCT00546078|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as GMTs calculated on all subjects.|At Month 7 and Month 18|Analysis was performed on the APT cohort for immunogenicity|||titer||95% Confidence Interval|Geometric Mean
2796679|NCT00546078|Primary|Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Day 7 and Month 1 (Day 30)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
2796680|NCT00546052|Other Pre-specified|Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments|Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks - C Reactive Protein Baseline.|52 Weeks - Baseline|Per Protocol|||mg/L||Standard Deviation|Mean
2796681|NCT00546052|Other Pre-specified|Absolute Change in Uric Acid Between Baseline and 52 Week Assessments|Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks - Uric Acid Baseline.|52 Weeks - Baseline|Per Protocol|||mmol/L||Standard Deviation|Mean
2796682|NCT00546052|Other Pre-specified|Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments|Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks - Total Cholesterol Baseline) / (Total Cholesterol Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Mean
2796683|NCT00546052|Other Pre-specified|Percent Change in Triglycerides Between Baseline and 52 Week Assessments|Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Median
2796684|NCT00546052|Other Pre-specified|Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Mean
2796685|NCT00546052|Other Pre-specified|Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)].|52 Weeks - Baseline|Per Protocol|||Percent Change||Standard Deviation|Mean
2796686|NCT00546052|Other Pre-specified|Change in Body Mass Index Between Baseline and 52 Week Assessments|Absolute change in Body Mass Index Baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol|||Kg/m2||Standard Deviation|Mean
2796687|NCT00546052|Other Pre-specified|Change in Waist Circumference Between Baseline and 52 Week Assessments|Absolute change in Waist Circumference between baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol|||cm||Standard Deviation|Mean
2796688|NCT00546052|Secondary|Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol|||mm Hg||Standard Deviation|Mean
2796689|NCT00546052|Secondary|Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol|||mm Hg||Standard Deviation|Mean
2796690|NCT00546052|Secondary|Target Blood Pressure|Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks|52 Weeks|ITT and Per Protocol|||Participants|||Number
2796691|NCT00546052|Primary|Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments|Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol|||mmol/L||Standard Deviation|Mean
2796692|NCT00546052|Primary|Change in Hemoglobin A1c Between 52 Weeks and Baseline|Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.|52 Weeks - Baseline|Per Protocol|||Percent||Standard Deviation|Median
2796693|NCT00546000|Secondary|Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity|The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.|Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29||||participants|||Number
2796694|NCT00546000|Primary|Post Treatment Serum Cortisol Values Will be Compared.|The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.|Up to 29 days of treatment||||participants|||Number
2796695|NCT00545974|Primary|Clinical Global Impression of Change (CGIC)|The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.|26 Weeks||||units on a scale||95% Confidence Interval|Mean
2796696|NCT00545974|Secondary|CDR-FTD, MMSE, FAQ, TFLS, EXIT25, UCSF FTD-Neuropsychological Test Battery: CVLT, Verbal Fluency, Modified BNT, Backward Digit Span, Digit Symbol Test, Modified Trails B, Modified Unified Parkinson's Disease Rating Scale, Antipsychotic Therapy||26 Weeks|||||||
2796697|NCT00545974|Primary|Change in Neuropsychiatric Inventory (NPI)|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Mean
2797008|NCT00543803|Primary|Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment|The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
2796698|NCT00545948|Secondary|Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.|2 years|There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.||||||
2796699|NCT00545948|Secondary|Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer|Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire.|Baseline|Twenty-six questionnaires were returned. There was insufficient numbers to provide for substantive analysis.||||||
2796700|NCT00545948|Secondary|2-Year Overall Survival in Patients Treated for NSCLC|Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||percentage of treated patients||95% Confidence Interval|Number
2796701|NCT00545948|Secondary|Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy|The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies.|4 years||||Percentage of participants|||Number
2796702|NCT00545948|Primary|2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC|Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||percentage of treated patients||95% Confidence Interval|Number
2796703|NCT00545844|Other Pre-specified|Patient Global Allergic Rhinitis Symptoms Assessment|At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
2796704|NCT00545844|Other Pre-specified|Physician Global Satisfaction|At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
2796705|NCT00545844|Other Pre-specified|Patient Global Satisfaction|At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
2796706|NCT00545844|Secondary|Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.|8 weeks (from Week 0 to Week 8)|There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8.|||Units on a Scale||Standard Deviation|Mean
2796707|NCT00545844|Secondary|The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score|Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score|8 weeks (from Week 0 to Week 8)|Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8.|||Units on a Scale||Standard Deviation|Mean
2796708|NCT00545844|Primary|Asthma Control|"Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered yes to at least 2 of the 8 asthma control parameters."|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.|||Participants|||Number
2796709|NCT00545792|Secondary|Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.|1-year|20 patients received and completed treatment.|||participants|||Number
2796710|NCT00545792|Primary|Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.|1-year|20 patients received and completed treatment.|||Events|||Number
2796711|NCT00545779|Secondary|Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction.|Baseline, Month 6|The ITT population included all participants who received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2796712|NCT00545779|Secondary|Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B||Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.||||||
2796713|NCT00545779|Secondary|Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B||Baseline to Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.||||||
2796714|NCT00545779|Secondary|Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2796715|NCT00545779|Secondary|Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B||Up to Month 6|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2796716|NCT00545779|Secondary|Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B|"Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication"|Month 6|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2796717|NCT00545779|Secondary|Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2796718|NCT00545779|Primary|Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group|Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.|Month 6|The intent-to treat (ITT) population included all participants who received at least one dose of study medication. Number of participant analyzed are with or without previous history of Fr.|||percentage of participants|||Number
2796719|NCT00545779|Primary|Percentage of Participants Who Reported Preference for Monthly Ibandronate|Percentage of participants who reported preference for monthly ibandronate were reported.|Visit 0 (<= Day -30)|All enrolled participants who completed the part A of the study.|||percentage of participants|||Number
2796720|NCT00545779|Primary|Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)|"The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.~In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication."|Visit 0 (less than or equal to [<=] Day -30)|All enrolled participants who completed the part A of the study.|||percentage of participants|||Number
2796721|NCT00545766|Secondary|Time to PSA Progression and Overall Survival Will be Summarized Via Kaplan-Meier-type Plots, and by Medians With Corresponding 95% Confidence Interval (CI).||18 months|||||||
2796722|NCT00545766|Primary|Protein-specific Antigen (PSA) Response Rate|Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.|18 months||||percentage of patients||95% Confidence Interval|Number
2796800|NCT00545532|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults|Reported here are oseltamivir tmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour||Standard Deviation|Mean
2796723|NCT00545753|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|558 subjects were randomized to treatment and 540 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. At Day 7 if subject presented with live lice they were provided a second treatment to be used within 24 hours. Thus subjects used 1 or 2 treatments.|||Incidents|||Number
2796724|NCT00545753|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.|||participants|||Number
2796725|NCT00545740|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||Up to 104 weeks|Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
2796726|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
2796727|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
2796728|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
2796729|NCT00545740|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
2796730|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT scans|||Number
2796731|NCT00545740|Secondary|Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
2796732|NCT00545714|Secondary|Percentage of Participants With Immunoglobulin Heavy Locus (IgH) Rearrangement|Percentages of participants with IgH rearrangement during the Induction Phase, Maintenance Phase, and Follow-Up were reported.|Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36|ITT Population. Here, 'Number Analyzed' signifies participants who were evaluable for indicated category.|||Percentage of Participants|||Number
2796733|NCT00545714|Secondary|Percentage of Participants With Positive and Negative Zeta-Chain-Associated Protein Kinase 70 (ZAP-70) Expression|Percentages of participants with positive and negative ZAP-70 expression during the Induction Phase, Maintenance Phase, and Follow-Up were reported. Positive ZAP-70 was defined as ZAP-70 expression by >/=20% of CLL cells. Negative ZAP-70 was defined as ZAP-70 expression by <20% of CLL cells.|Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36|ITT Population. Here, 'Number Analyzed' signifies participants who were evaluable for indicated category.|||Percentage of Participants|||Number
2796734|NCT00545714|Secondary|Percentage of Participants With Genetic Abnormalities|Percentages of participants with genetic abnormalities (deletion 6q, deletion 11q22-q23, deletion p53, trisomy 12, and deletion 13q14) in the course of the disease during the Induction Phase and Maintenance Phase were reported.|Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months)|ITT Population. Here, 'Number Analyzed' signifies participants who were evaluable for indicated category. Designation of 'MP (xC)' refers to number of cycles in Maintenance Phase.|||Percentage of Participants|||Number
2797306|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2796735|NCT00545714|Secondary|Percentage of Participants With Cluster of Differentiation (CD) 38 Cells >/=30% in Peripheral Blood|Percentages of participants with CD38 expression by >/=30% of CLL cells during the Induction Phase, Maintenance Phase, and Follow-Up were reported.|Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36|ITT Population. Here, 'Number Analyzed' signifies participants who were evaluable for indicated category.|||Percentage of Participants|||Number
2796736|NCT00545714|Secondary|Duration of Response (DOR)|DOR: time from CR/PR to MRD/PD. PD: new ADP (1.5 cm), HSM, RS, other infiltrated organs or >/=50% increase size in those with PR; blood Lymph increase >/=50% with B Lymph >/=5000/mm^3; cytopenia due to CLL. Progression of (nonautoimmune) cytopenia: 2-g/dL decrease basal Hb, Hb <10 g/dL, >/=50% decrease basal Plt or <100,000/mm^3 at >/=3 months post-treatment was PD if clonal CLL cell infiltration on BM biopsy. CR: no ADP/VSM in PE; no general Sx; blood Lymph <4000/mm^3; Neut >1500/mm^3; Plt >100,000/mm^3; Hb >11 g/dL (no transfusion); normocellular BM with <30% Lymph; BM aspirate/biopsy with no lymphoid nodule infiltration. PR: >50% decrease blood Lymph; >50% decrease in total sum up to 6 ADPs or baseline ADP of LD, no new/enlargement of prior ADP; >50% decrease VSM; Neut >1500/mm^3 or >50% increase; Plt >100,000/mm^3 or >50% increase; Hb >11.0 g/dL or >50% increase (no transfusion). All CR criteria but persistent anemia or thrombocytopenia was PR. MRD: Lymph >0.01% of blood/BM WBCs.|From first CR or PR up to detectable MRD or disease occurrence/PD, whichever occurred first (up to 92 months)|ITT Population. Only those participants who achieved a clinical response of CR or PR were evaluable for this measure.|||Years||95% Confidence Interval|Median
2796737|NCT00545714|Secondary|Treatment-Free Survival (TFS)|TFS was defined time from start of study treatment until participant received new chemotherapy/immunotherapy because of PD and to reduce the disease with palliative or curative intent. PD was defined as new ADPs (1.5 cm), HSM, RS, or other infiltrated organs; >/=50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase >/=50% in peripheral blood with B Lymph >/=5000/mm^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb <10 g/dL, >/=50% decrease in basal Plt count, or count <100,000/mm^3 at >/=3 months post-treatment was defined as PD if BM biopsy confirmed infiltration of clonal CLL cells.|Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)|ITT Population. Only those who received new chemotherapy/immunotherapy, as per definitions for TFS, were included in the analysis.|||Years||95% Confidence Interval|Median
2796738|NCT00545714|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from start of study treatment to PD or death, whichever occurred first. For other participants, last follow-up available was taken as last control. If participant did not complete study, date of last visit available was considered. PFS was estimated using KM methodology. PD was defined as new ADPs (1.5 cm), HSM, RS, or other infiltrated organs; >/=50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase >/=50% in peripheral blood with B Lymph >/=5000/mm^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb <10 g/dL, >/=50% decrease in basal Plt count, or count <100,000/mm^3 at >/=3 months post-treatment was defined as PD if BM biopsy confirmed infiltration of clonal CLL cells.|Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)|ITT Population|||Years||95% Confidence Interval|Median
2796739|NCT00545714|Secondary|Percentage of Participants With PD or Death|PD was defined as new ADPs (1.5 centimeters [cm]), hepato-/splenomegaly (HSM), Richter syndrome (RS), or other infiltrated organs; greater than or equal to (>/=) 50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase >/=50% in peripheral blood with B Lymph >/=5000/mm^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb <10 g/dL, >/=50% decrease in basal Plt count, or count <100,000/mm^3 at >/=3 months post-treatment was defined as PD if BM biopsy confirmed infiltration of clonal CLL cells.|Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)|ITT Population|||Percentage of Participants|||Number
2796740|NCT00545714|Secondary|Overall Survival (OS)|OS was defined as time from treatment start to death of the participant. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered. OS was estimated using Kaplan-Meier (KM) methodology.|Baseline up to death due to any cause (up to 92 months)|ITT Population|||Years||95% Confidence Interval|Median
2796741|NCT00545714|Secondary|Percentage of Participants Who Died||Baseline up to death due to any cause (up to 92 months)|Safety Population|||Percentage of Participants|||Number
2796742|NCT00545714|Secondary|Percentage of Participants With CR With Incomplete Bone Marrow Recovery (CRi)|Participants with CRi were those who met all CR criteria (including BM examinations) but had persistent anemia, thrombocytopenia, or neutropenia apparently unrelated to chronic lymphocytic leukemia (CLL) but related to drug toxicity. CR: no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood <4000/mm^3; normalization of peripheral blood parameters: Neut >1500/mm^3, Plt >100,000/mm^3, Hb >11 g/dL without transfusion; normocellular BM with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules.|Baseline up to progressive disease (PD) or death due to any cause, whichever occurred first (up to 92 months)|ITT Population|||Percentage of Participants|||Number
2796750|NCT00545688|Secondary|Time to Clinical Response During Neo-Adjuvant Treatment Period|Time to clinical response was defined as the time from the date of first dose received to the date of assessment of clinical response. Time to Clinical response was determined by Kaplan-Meier estimates. Tumor assessments were made based on the RECIST criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||months||80% Confidence Interval|Median
2796743|NCT00545714|Secondary|Percentage of Participants With Clinical Response of CR or PR Among Participants With Negative Minimal Residual Disease (MRD) as Assessed by Multiparameter Flow Cytometry|CR: no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood <4000/mm^3; normalization of peripheral blood parameters: Neut >1500/mm^3, Plt >100,000/mm^3, Hb >11 g/dL without transfusion; normocellular BM with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. PR: decrease >50% in Lymph in peripheral blood; reduction in ADPs >50% in total sum of up to 6 ADPs or in the baseline ADP of largest diameter (LD), no new ADP or enlargement of a prior ADP; >50% decrease in VSM; Neut >1500/mm^3 or >50% increase from Baseline; Plt >100,000/mm^3 or >50% increase from Baseline; Hb >11.0 g/dL or >50% increase from Baseline value without transfusion. Participants who met all CR criteria but had persistent anemia or thrombocytopenia were considered as PR. Negative MRD: Lymph <0.01% of all white blood cells (WBCs) in blood or BM after two consecutive measurements. Analysis performed only in blood during the Maintenance Phase and Follow-Up.|Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 36|ITT Population. Only those with negative MRD were included in the analysis. Here, 'Number Analyzed' signifies participants who were evaluable for indicated category.|||Percentage of Participants|||Number
2796744|NCT00545714|Secondary|Percentage of Participants With Clinical Response of CR or PR as Assessed by Multiparameter Flow Cytometry|CR was defined as no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood <4000/mm^3; normalization of peripheral blood parameters: Neut >1500/mm^3, Plt >100,000/mm^3, Hb >11 g/dL without transfusion; normocellular BM with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. PR was defined as decrease >50% in Lymph in peripheral blood; reduction in ADPs >50% in total sum of up to 6 ADPs or in the baseline ADP of largest diameter (LD), no new ADP or enlargement of a prior ADP; >50% decrease in VSM; Neut >1500/mm^3 or >50% increase from Baseline; Plt >100,000/mm^3 or >50% increase from Baseline; Hb >11.0 g/dL or >50% increase from Baseline value without transfusion. Participants who met all CR criteria but had persistent anemia or thrombocytopenia were considered as PR.|Post-Induction Phase (IP): at 6 months; during Maintenance Phase (MP): at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up (FU): at Follow-Up Months 6, 12, 18, 24, 30, 36|ITT Population. Here, 'Number Analyzed' signifies participants who were evaluable for indicated category.|||Percentage of Participants|||Number
2796745|NCT00545714|Primary|Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen|CR was defined as no adenopathies (ADPs) and visceromegalies (VSMs) in physical examination (PE); no general symptoms (Sx); lymphocytes (Lymph) in peripheral blood less than (<) 4000 per cubic millimeter (mm^3); normalization of peripheral blood parameters: neutrophils (Neut) greater than (>) 1500/mm^3, platelets (Plt) >100,000/mm^3, hemoglobin (Hb) >11 grams per deciliter (g/dL) without transfusion; normocellular bone marrow (BM) with <30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules.|Month 9|ITT Population included all participants who received at least one dose of study drug and met inclusion/exclusion criteria.|||Percentage of Participants||95% Confidence Interval|Number
2796746|NCT00545688|Secondary|Progression Free and Disease Free Survival|DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants||80% Confidence Interval|Median
2796747|NCT00545688|Secondary|Percentage of Participants Who Were Progression Free and Disease Free|Disease-free survival (DFS) was defined as the time from first date of no disease to first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from the study without documented progression and for whom evaluations were made, were censored at date of last assessment when participant was known to be disease-free. Progression-free survival (PFS) was defined as time from date of randomization to first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from study without documented progression and for whom evaluations were made, were censored at date of last assessment when the participant was known to be free from progressive disease. Participants without post baseline assessments but known to be alive were censored at the time of randomization.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants|||Number
2796748|NCT00545688|Secondary|Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned|Breast Conserving Surgery (BCS) was defined as quadrantectomy, lumpectomy, no surgery, sentinel node biopsy, axillary surgical resection or other method of avoiding mastectomy.|Surgery (Within 2 weeks after Cycle 4) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2796749|NCT00545688|Secondary|Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: PD: if lesion is at least a 20 % increased from measurements at baseline. Percentage of participants along with 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method were reported. Missing investigator assessments were considered as no progressive disease.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2797009|NCT00543803|Primary|Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment|The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
2796751|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Primary breast tumor clinical response is based on primary breast tumor assessment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.|||percentage of participants||95% Confidence Interval|Number
2796752|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography|Clinical response was determined based on tumor measurements by sponsor in combination with tumor response assessment by investigator. Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.|||percentage of participants||95% Confidence Interval|Number
2796753|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
2796754|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
2796755|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography|Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
2796756|NCT00545688|Primary|Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants|||Number
2796757|NCT00545688|Primary|Percentage of Participants Achieving pCR by Lymph Node Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants|||Number
2796758|NCT00545688|Primary|Percentage of Participants Achieving pCR by Hormone Receptor Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.|||percentage of participants||95% Confidence Interval|Number
2796759|NCT00545688|Primary|Percentage of Participants Achieving pCR by Breast Cancer Type|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. Number (n) equal (=) number of participants included in the specified type of breast cancer.|||percentage of participants||95% Confidence Interval|Number
2796760|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.|Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
2796761|NCT00545688|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2796762|NCT00545662|Primary|Functional and Cognitive Outcome|The primary outcome of this study was analyzed using a global statistic of the Network Core Battery. There were 9 scales: California Verbal Learning Test II (CVLT-II); Controlled Oral Word Association Test (COWAT); Digit Span (DS); Glasgow Outcome Scale Extended (GOSE); Processing Speed Index (PSI); Stroop Test 1 and 2 (ST1&2); and Trail Making Test part A and B (TMT parts A and B). Each scale was assigned cut-off for good outcome: GOSE>7, CVLT>36, PSI>85, TMT part A <42, TMT part B<138.1, DS>7.15, ST1<60.29, ST2<151.47, COWAT>32.5. Logistic regression was used to estimate the global OR.|90 days|The analysis included both the patients with complete outcome data and those with at least one measure. Patients who died were also included in the analysis.|||percentage of participants|||Number
2796763|NCT00545623|Primary|Changes in GI Symptom Per Intervention Session|We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.|8 weeks|An intent-to-treat approach was used for analysis. That is all patients who had at least one data points were included in the analysis.|||units on a scale||Standard Error|Mean
2796764|NCT00545584|Secondary|Fasting Plasma Glucose (FPG) Measurement|Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).|Baseline and Week 24|FAS population. Furthermore, only 350, 252, and 350 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Baseline; and 303, 224, and 310 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Week 24.|||mmol/L glucose||Standard Deviation|Mean
2796765|NCT00545584|Primary|Hemoglobin A1c Measurement|Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.|Baseline and Week 24|The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin. In the Standard of Care group, only 360 subjects had HbA1c Baseline evaluations.|||percent HbA1c||Standard Deviation|Mean
2796766|NCT00545571|Secondary|Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported.|From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52|ITT Population.|||percentage of participants|||Number
2796767|NCT00545571|Secondary|Mean Dose of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and LTSP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population; only those participants (n = number) who provided evaluable data were included in the analysis.|||mcg||Standard Deviation|Mean
2796768|NCT00545571|Secondary|Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population: All participants who received at least one dose of trial medication and at least one safety follow-up assessment, whether prematurely withdrawn or not; only those participants (n = number) who provided evaluable data were included in the analysis.|||months||Standard Deviation|Mean
2796769|NCT00545571|Secondary|Mean Excursions Above or Below Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Deviation from the country-specific target range was calculated as [Hb value minus country-specific upper bound] for deviations above the target range and [Hb value minus country-specific lower bound] for deviations below the target range. Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.|||g/dL||Standard Deviation|Mean
2796770|NCT00545571|Secondary|Mean Time Spent Above or Below the Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP. Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP or at the last DTP visit were included in the analysis.|||days||Standard Deviation|Mean
2796771|NCT00545571|Secondary|Percentage of Hb Values Above or Below the Target Range During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.|||percentage of Hb values|||Number
2796772|NCT00545571|Secondary|Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2796773|NCT00545571|Secondary|Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only participants who entered the LTSP were included in the analysis.|||days||Standard Deviation|Mean
2796774|NCT00545571|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.|||g/dL||Standard Deviation|Mean
2797307|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2796775|NCT00545571|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|Per Protocol (PP) Population: All participants from the Intent-to-Treat (ITT) Population who fulfill select criteria per study protocol.|||percentage of participants||95% Confidence Interval|Number
2796776|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||Liter (L)|||Number
2796777|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||L/hr|||Number
2796778|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr|||Number
2796779|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children|Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||Liter (L)|||Number
2796780|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children|Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||L/hr|||Number
2796781|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children|Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr|||Number
2796782|NCT00545532|Secondary|Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour|||Number
2796783|NCT00545532|Secondary|Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children|AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL|||Number
2796784|NCT00545532|Secondary|Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
2796785|NCT00545532|Secondary|Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children|Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
2796786|NCT00545532|Secondary|Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children|Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour|||Number
2796787|NCT00545532|Secondary|Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children|AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose|The PKEP population comprised all subjects in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL|||Number
2796788|NCT00545532|Secondary|Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children|Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
2796789|NCT00545532|Secondary|Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children|Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL|||Number
2796790|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||liter (L)||Standard Deviation|Mean
2796791|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||L/hr||Standard Deviation|Mean
2796792|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults|Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr||Standard Deviation|Mean
2796793|NCT00545532|Secondary|Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||hour||Standard Deviation|Mean
2796794|NCT00545532|Secondary|Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all particiants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL||Standard Deviation|Mean
2796795|NCT00545532|Secondary|Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL||Standard Deviation|Mean
2796796|NCT00545532|Secondary|Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults|Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL||Standard Deviation|Mean
2796797|NCT00545532|Secondary|Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults|Reported here are oseltamivir Vc/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||liter (L)||Standard Deviation|Mean
2796798|NCT00545532|Secondary|Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults|Reported here are oseltamivir CL/F data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||liter/hour (L/hr)||Standard Deviation|Mean
2796799|NCT00545532|Secondary|Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults|Reported here are oseltamivir ke data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||1/hr||Standard Deviation|Mean
2797010|NCT00543803|Primary|Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment|The change in total cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
2796801|NCT00545532|Secondary|Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults|AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng*hr/mL||Standard Deviation|Mean
2796802|NCT00545532|Secondary|Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults|Reported here are oseltamivir Ctrough data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||ng/mL||Standard Deviation|Mean
2796803|NCT00545532|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults|Reported here are oseltamivir Cmax data for adults >/= 18 years.|Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose|The pharmacokinetic evaluable patient (PKEP) population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2796804|NCT00545532|Secondary|Duration of Hospitalization|Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||days||Full Range|Median
2796805|NCT00545532|Secondary|Percentage of Participants Hospitalized|Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
2796806|NCT00545532|Secondary|Percentage of Participants Who Initiated Antibiotic Treatment|Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||percentage of participants|||Number
2796807|NCT00545532|Secondary|Percentage of Participants Who Developed Secondary Illness|Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
2796808|NCT00545532|Secondary|Percentage of Participants With Persistent Viral Shedding|Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years.|Baseline to Day 11 (EOT)|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
2796809|NCT00545532|Secondary|Time to Cessation of Viral Shedding by RT-PCR|Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||hours||95% Confidence Interval|Median
2796810|NCT00545532|Secondary|Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time|Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
2796811|NCT00545532|Secondary|Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)|Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||log10 vp/mL||Full Range|Median
2796812|NCT00545532|Secondary|Time to Cessation of Viral Shedding by Cell Culture|Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||hours||95% Confidence Interval|Median
2796813|NCT00545532|Secondary|Percentage of Participants With Viral Shedding Assessed by Culture Over Time|Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
2796814|NCT00545532|Secondary|Change From Baseline in Viral Load Assessed by Culture|Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years.|Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||TCID50/mL||Full Range|Median
2796815|NCT00545532|Secondary|Time to Resolution of Fever|Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||hours||95% Confidence Interval|Median
2796816|NCT00545532|Secondary|Total Symptom Score Area Under the Efficacy Curve (AUE)|The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||score * hour||Full Range|Median
2796817|NCT00545532|Secondary|Time to Resolution (TTR) of All Clinical Influenza Symptoms|TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population.|Baseline up to Day 40|mITTi: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline, and for whom data were available.|||hours||95% Confidence Interval|Median
2796818|NCT00545532|Primary|Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)|The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.|Baseline up to Day 40|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||percentage of participants|||Number
2796819|NCT00545532|Primary|Percentage of Participants Who Developed Viral Resistance to Oseltamivir|Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population.|Baseline up to Day 40|mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.|||percentage of participants|||Number
2797093|NCT00543309|Secondary|Resource Utilization: Days of Initial CICU Stay|Days of initial postoperative CICU care following the Fontan operation.|From Fontan operation until initial discharge from the CICU, assessed during the postoperative hospitalization, up to 90 days.||||days||Full Range|Median
2796820|NCT00545532|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to Day 40|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||percentage of participants|||Number
2796821|NCT00545506|Primary|Tissue Oxygen Tension in the Sternal Wound|Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.|8 hours||||mmHG|||Number
2796822|NCT00545506|Primary|Tissue Oxygenation Levels||2 years||2009-11-30|11/2009||||
2796823|NCT00545441|Primary|Healing Success|"Healing was defined as closure of external opening with absence of abscess, drainage and pain."|12 months|Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated.|||participants|||Number
2796824|NCT00545402|Secondary|Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review|The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population; only participants with evaluable biopsies were included in the analysis.|||percentage of participants|||Number
2796825|NCT00545402|Secondary|Overall Survival at Month 12|The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population|||months||Full Range|Median
2796826|NCT00545402|Secondary|Overall Survival (OS) at Month 12 - Percentage of Participants With an Event|OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population|||percentage of participants|||Number
2796827|NCT00545402|Secondary|Graft Survival|The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population|||months||Full Range|Median
2796828|NCT00545402|Secondary|Percentage of Participants With Graft Loss|Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population|||percentage of participants|||Number
2796829|NCT00545402|Primary|Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant|Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment|ITT population|||percentage of participants|||Number
2796830|NCT00545363|Secondary|Percent Change From Baseline in CTX Based on Adherence to Ibandronate|Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Baseline, Month 6|"ITT population. Number of participants analyzed = participants evaluable for this outcome and n represents number of participants analyzed for the specified category."|||percent change||95% Confidence Interval|Least Squares Mean
2796831|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score|OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
2797308|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2796832|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.|||percentage of participants|||Number
2796833|NCT00545363|Primary|Percentage of Participants With Adherence to Treatment|Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Up to 6 months|Intent to treat (ITT) population included all randomized participants. Number of participants analyzed=number of participants evaluable for this outcome.|||percentage of participants|||Number
2796834|NCT00545298|Primary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|All reported adverse events, related or unrelated to the study drug.|up to 24 weeks|All enrolled subjects, 4 in total|||number of events|||Number
2796835|NCT00545298|Primary|Wound Healing|% Re-epithelialization|Week 20|Per protocol. Only one subject met the 20 week time point. All other subjects withdrew early from the study and did not reach the Week 20 time point|||% re-epithelialization|||Number
2796836|NCT00545272|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat|||participants|||Number
2796837|NCT00545272|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period)|"Intent to treat population. The analysis only includes patients with non-missing data, indicated by N."|||liters/minute||Standard Deviation|Mean
2796838|NCT00545272|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."|||minutes||Standard Deviation|Mean
2796839|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
2796840|NCT00545272|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
2796841|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.|||liters||Standard Error|Least Squares Mean
2796842|NCT00545272|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.|||liters||Standard Error|Least Squares Mean
2796862|NCT00545233|Secondary|Percentage of Participants Achieving Virologic Response|Virologic response was defined as undetectable HCV RNA < 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.|Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.|||Percentage of Participants|||Number
2796843|NCT00545233|Secondary|Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed|The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.|Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.|||Percentage of Participants|||Number
2796844|NCT00545233|Secondary|Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed|"Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
2796845|NCT00545233|Secondary|Change From Baseline in Leptin Levels at Each Time Point Assessed|"Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||ng/mL||Standard Error|Mean
2796846|NCT00545233|Secondary|Change From Baseline in Adiponectin Levels at Each Time Point Assessed|"Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||μg/mL||Standard Error|Mean
2796847|NCT00545233|Secondary|Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed|"Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||pg/mL||Standard Error|Mean
2796848|NCT00545233|Secondary|Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed|"Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||pg/mL||Standard Error|Mean
2796849|NCT00545233|Secondary|Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
2796850|NCT00545233|Secondary|Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
2796851|NCT00545233|Secondary|Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
2796877|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
2796852|NCT00545233|Secondary|Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed|"Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
2796853|NCT00545233|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed|"Insulin resistance (IR) is calculated using the following formula:~HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405.~Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated.~A normal patient can have a HOMA score up to 3. A patient with a score of >3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||HOMA Score||Standard Error|Mean
2796854|NCT00545233|Secondary|Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed|"Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||Percent||Standard Error|Mean
2796855|NCT00545233|Secondary|Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.|"Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||pmol/L||Standard Error|Mean
2796856|NCT00545233|Secondary|Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed|"Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.|||mmol/L||Standard Error|Mean
2796857|NCT00545233|Secondary|Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only|Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.|Randomization (Week-16),Weeks -12, -8, -4 and 0|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||IU/mL||Standard Error|Mean
2796858|NCT00545233|Secondary|Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period|Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
2796859|NCT00545233|Secondary|Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks|Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
2796860|NCT00545233|Secondary|Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)|Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.|Week 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
2796861|NCT00545233|Secondary|Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72|Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.|Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.|||Percentage of Participants|||Number
2796878|NCT00545103|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||up to 104 Weeks|Full Analysis Set|||percentage of subjects|||Number
2796863|NCT00545233|Secondary|Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.|||IU/mL||Standard Error|Mean
2796864|NCT00545233|Primary|Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.|||IU/mL||Standard Error|Mean
2796865|NCT00545181|Primary|Recurrent Bacterial Vaginosis|Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.|3 months||||Participants|||Number
2796866|NCT00545168|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.|||participants|||Number
2796867|NCT00545168|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|480 subjects were randomized to treatment and 469 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. Thus subjects used 1 or 2 treatments.|||Incidents|||Number
2796868|NCT00545155|Primary|Concurrent Criterion Validity of PHQ-2|"This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression.~This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours||||kappa||95% Confidence Interval|Number
2796869|NCT00545155|Primary|Test-Retest Reliability Testing of PHQ-2 Screening|The test for depression, using the PHQ-2, with scoring yes or no.|2 hours||||kappa||95% Confidence Interval|Number
2796870|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
2796871|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
2796872|NCT00545155|Primary|Proportion of Subjects Depressed in EMS.|Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
2796873|NCT00545155|Primary|Concurrent Criterion Validity of Six Item Screener Screening|"This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards.~This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours||||kappa||95% Confidence Interval|Number
2796874|NCT00545155|Primary|Test-Retest Reliability of Six Item Screener Screening|The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.|2 hours|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||kappa||95% Confidence Interval|Number
2796875|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the ED|Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.|Within 2 hours of testing by EMS|All of the subjects enrolled who completed follow up and completed all aspects of the testing.|||percentage of subjects|||Number
2796876|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.|Within 2 hours of testing by EMS.|All of the subjects enrolled who completed all aspects of the testing.|||percentage of subjects|||Number
2796879|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
2796880|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
2796881|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
2796882|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 Weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.|||Number of CT Scans|||Number
2796883|NCT00545103|Secondary|Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|up to 104 weeks|Full Analysis Set|||percentage of subjects|||Number
2796884|NCT00545103|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|up to 104 Weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.|||percentage of subjects|||Number
2796885|NCT00545077|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of patients achieving a Complete Response (CR), a Partial Response (PR) or a stabilization of the disease (SD) > 6 months: the response will be evaluated according to the RECIST criteria. In the patients without measurable disease at the baseline time, the clinical benefit will be defined as the absence of progression > 6 months.|Up to 2 years|"Arm A: 189 patients were randomized, but only 184 started treatment due to patient´s wish.~Arm B: 191 patients were randomized, but only 190 started treatment due to patient´s wish."|||Participants|||Count of Participants
2796886|NCT00545077|Secondary|Response Duration (RD)|RD was defined as the time elapsed from when a partial or complete response is verified until the time in which progression or death occurs.|Up to 2 years|Only patients with partial or complete response were taken into account|||Months||95% Confidence Interval|Median
2796887|NCT00545077|Secondary|Overall Response Rate (ORR)|ORR to treatment is reflected by a frequency table containing the data of the best overall response (Complete Response, Partial Response,Stable Disease or Progressive Disease) experienced for each patient during treatment (recorded from the start of the treatment until disease progression) per arm.|2 years|Only patients with measurable lesions were taken into account|||Participants|||Count of Participants
2796888|NCT00545077|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time elapsed since randomization until the date the treatment is discontinued for any reason (progression disease, treatment toxicity or death).|Up to 2 years|"Arm A: 189 patients were randomized, but only 184 started treatment due to patient´s wish.~Arm B: 191 patients were randomized, but only 190 started treatment due to patient´s wish."|||Months||95% Confidence Interval|Median
2796889|NCT00545077|Secondary|Overall Survival (OS)|OS was defined as the time elapsed since randomization, until the time in which death occurs for any reason. The patients lost in the follow-up will be censured at the date of the last follow-up.|Up to 2 years|"Arm A: 189 patients were randomized, but only 184 started treatment due to patient´s wish.~Arm B: 191 patients were randomized, but only 190 started treatment due to patient´s wish."|||Months||95% Confidence Interval|Median
2796890|NCT00545077|Primary|Progression-free Survival (PFS)|PFS was defined as the time elapsed from randomization until the date in which the progression of the disease or the death for any reason (whichever occurs first) is documented.|Up to 2 years|"Arm A: 189 patients were randomized, but only 184 started treatment due to patient´s wish.~Arm B: 191 patients were randomized, but only 190 started treatment due to patient´s wish."|||Months||95% Confidence Interval|Median
2796891|NCT00545064|Other Pre-specified|Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol|IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.|Baseline to Week 4 and from Baseline to Week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on IOP were available for 164 and 166 patients at week 4 and 8 respectively|||mm Hg||Standard Deviation|Mean
2796947|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase I)|Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death.|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. One patient did not experience toxicity.|||participants|||Number
2796892|NCT00545064|Other Pre-specified|Physician's Global Satisfaction|At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).|||Participants|||Number
2796893|NCT00545064|Other Pre-specified|Patient's Global Satisfaction|At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).|||Participants|||Number
2796894|NCT00545064|Primary|Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score|GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.|Baseline to week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on GSS-SYMP-6 were available for 114 and 111 patients at week 4 and 8 respectively|||Units on a Scale||Standard Deviation|Mean
2796895|NCT00545051|Secondary|Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months|Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.|Month 6|ITT population|||percentage of participants|||Number
2796896|NCT00545051|Secondary|Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.|Baseline and Months 1, 6 and 12|ITT population; n=number of participants analyzed at the specified visit for the given parameter.|||percent change in bone turnover markers||Standard Deviation|Mean
2796897|NCT00545051|Secondary|Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12|Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.|Baseline and Months 6 and 12|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.|||percent change in BMD||Standard Deviation|Mean
2796898|NCT00545051|Secondary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6|Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.|Baseline and Month 6|ITT Population|||percent change in BMD||Standard Deviation|Mean
2796899|NCT00545051|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.|Baseline and Month 12|Intent-to-treat (ITT) population|||percent change in BMD||Standard Deviation|Mean
2796900|NCT00545025|Secondary|Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2796901|NCT00545025|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Subjects|||Number
2796902|NCT00545025|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Subjects|||Number
2796903|NCT00545025|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.|||Titer||95% Confidence Interval|Geometric Mean
2796904|NCT00545025|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-30)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2796905|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 30-day (Days 0-29) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2796906|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During a 7-day (Days 0-6) follow-up after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2796907|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.|During a 7-day (Days 0-6) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2796908|NCT00544908|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After every two cycles, up to 5 years||||percentage of participants|||Number
2796909|NCT00544908|Primary|Progression-free Survival (PFS) Rate at 4 Months|Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).|Four months.||||percentage of participants|||Number
2796910|NCT00544882|Secondary|Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||percentage of participants|||Number
2796911|NCT00544882|Secondary|Number of Days of Bleeding During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||days||Standard Deviation|Mean
2796912|NCT00544882|Secondary|Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||percentage of participants|||Number
2796913|NCT00544882|Secondary|Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat|||days||Standard Deviation|Mean
2796914|NCT00544882|Secondary|Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size|The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.|Cycle 2, Days 1-20 and Cycle 2, Days 21-28|Intent-to-treat population with available data.|||mm||Standard Deviation|Mean
2796915|NCT00544882|Primary|Serum Inhibin-B Levels by Cycle Day|Levels of inhibin-B were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).|||pg/mL||Full Range|Median
2796916|NCT00544882|Primary|Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day|Levels of follicle stimulating hormone were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).|||mIU/mL||Full Range|Median
2796917|NCT00544882|Secondary|Percentage of Follicles Greater Than 5 mm in Diameter|Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).|Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.|Intent-to-treat|||percentage of follicles|||Number
2796918|NCT00544882|Primary|Serum Estradiol Levels by Cycle Day|Levels of estradiol were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).|||pg/mL||Full Range|Median
2796919|NCT00544869|Primary|Body Weight|The change of body weight from baseline at final observation|Baseline, Day 14 or at the time of final drug administration||||Kg||Standard Deviation|Mean
2796988|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.|||Number of Participants|||Number
2796920|NCT00544817|Secondary|Objective Response|"The number of patients with complete or partial responses measured from the time of initial response to documented tumor progression. Radiologic response was defined using the Macdonald criteria.~The Macdonald criteria divides response into 4 types of response based on imaging (MRI) and clinical features, as follows: 1) complete response (CR); 2) partial response (PR); 3) stable disease (SD); and 4) progression (PD).~Criteria:~CR: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions. No corticosteroids, clinically stable or improved.~PR: >=50% decrease of all measurable enhancing lesions, sustained for at least 4 weeks, no new lesions. Stable or reduced corticosteroids, clinically stable or improved.~SD: does not qualify for complete response, partial response or progression. Clinically stable.~PD: >= 25% increase in enhancing lesions, any new lesions. Clinical deterioration."|every 8 weeks until disease progression, estimated 18 months||||participants|||Number
2796921|NCT00544817|Secondary|Overall Survival|Defined as Day 1 of protocol treatment to date of death from any cause.|18 months||||Months||95% Confidence Interval|Median
2796922|NCT00544817|Primary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|18 months||||Months||95% Confidence Interval|Median
2796923|NCT00544778|Primary|Response Rate|Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.|First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.||||percentage of patients responding|||Number
2796924|NCT00544713|Secondary|Change From Baseline in Study Product Usage at Day 90|Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).|Baseline, Day 90|Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use).|||Number of study product uses per day||Standard Deviation|Mean
2796925|NCT00544713|Other Pre-specified|Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60|Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.|Day 14, Day 60|Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed).|||Number of patients|||Number
2796926|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90|Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Number of seconds||Standard Deviation|Mean
2796927|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90|Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Scores on a Scale||Standard Deviation|Mean
2796928|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90|Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent to Treat population defined as all patients who started the study and were randomized|||Scores on a Scale||Standard Deviation|Mean
2796929|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Schirmer's Test at Day 90|Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Millimeters of Tears||Standard Deviation|Mean
2796930|NCT00544713|Secondary|Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90|Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Microns||Standard Deviation|Mean
2796931|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90|Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Units on a scale||Standard Deviation|Mean
2796989|NCT00544167|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.||18 Months||||percentage of patients|||Number
2796932|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90|Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized|||Units on a scale||Standard Deviation|Mean
2796933|NCT00544713|Secondary|Best Corrected Visual Acuity (BCVA) Status at Day 90|"BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly."|Day 90|Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure.|||Number of Patients|||Number
2796934|NCT00544713|Secondary|Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).|||Percentage of Patients|||Number
2796935|NCT00544713|Secondary|Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).|||Percentage of Patients|||Number
2796936|NCT00544713|Primary|Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90|Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).|Day 90|Intent to Treat population defined as all patients who started the study and were randomized|||Scores on a Scale||Standard Deviation|Mean
2796937|NCT00544674|Secondary|Pharmacokinetics||Days 1 and 2 of Cycles 1 and 4|||||||
2796938|NCT00544674|Primary|Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment||||participants|||Number
2796939|NCT00544674|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From registration of the first subject until radiological progression or recurrence whichever came first|||||||
2796940|NCT00544674|Secondary|Progression-free Survival|Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.|Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy|||||||
2796941|NCT00544674|Secondary|Survival||Every 3 months for 2 years after discontinuation|||||||
2796942|NCT00544674|Primary|Response Rate (Complete or Partial)||From registration until disease progression/recurrence|||||||
2796943|NCT00544648|Other Pre-specified|Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression|Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens.|On receipt of tumor tissue blocks|Investigators elected not to perform this analysis.||||||
2796944|NCT00544648|Secondary|Response (Phase II)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (n = 0) or if the patient is non-evaluable for best overall response (n = 1)|||participants|||Number
2796945|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase II)|The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 16 weeks|Treated patients who experienced a toxicity.|||participants|||Number
2796946|NCT00544648|Secondary|Overall Survival (Phase II)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival|Time Frame: date on study to date of death from any cause or last known date alive|Too few patients were enrolled in the Phase II arm for an analysis of overall survival||||||
2796948|NCT00544648|Secondary|Response (Phase I)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (0) or if the patient is non-evaluable for best overall response (n = 1)|||participants|||Number
2796949|NCT00544648|Secondary|Overall Survival (Phase I)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.|||days||95% Confidence Interval|Median
2796950|NCT00544648|Secondary|Progression-free Survival (Phase I)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.|||days||95% Confidence Interval|Median
2796951|NCT00544648|Primary|Progression-free Survival (Phase II)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.|||days||95% Confidence Interval|Median
2796952|NCT00544648|Primary|Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I)|The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks.|7 weeks|MTD based on clinical performance of those patients who received the study drug. One patient withdrew before receiving treatment. No formal statistical analysis, such as hypothesis testing, was performed.|||mg/m2|||Number
2796953|NCT00544557|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.|||percentage of participants|||Number
2796954|NCT00544557|Secondary|Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis|Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.|||percentage of participants|||Number
2796955|NCT00544557|Secondary|Duration of Healthcare Resources Utilization|Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||days||Standard Deviation|Mean
2796956|NCT00544557|Secondary|Healthcare Resource Utilization|Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||events||Standard Deviation|Mean
2796957|NCT00544557|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||percentage of impairment||Standard Deviation|Mean
2796958|NCT00544557|Secondary|Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796959|NCT00544557|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796960|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants||95% Confidence Interval|Number
2796961|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response|ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants||95% Confidence Interval|Number
2796962|NCT00544557|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||mm/hr||Standard Deviation|Mean
2796963|NCT00544557|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2796964|NCT00544557|Secondary|Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||body parts||Standard Deviation|Mean
2796990|NCT00544076|Secondary|Penile Length|measurement of penile length in centimeters|At pre-treatment and 18 months|patients who were willing to have penile measurements taken at baseline|||centimeters||Full Range|Median
2796965|NCT00544557|Secondary|Percentage of Participants With Presence of Enthesitis|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants|||Number
2796966|NCT00544557|Secondary|Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||joints||Standard Deviation|Mean
2796967|NCT00544557|Secondary|Percentage of Participants With Presence of Peripheral Arthritis|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants|||Number
2796968|NCT00544557|Secondary|Percentage of Participants With Significant Reduction of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).|Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.|||percentage of participants|||Number
2796969|NCT00544557|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 52|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||minutes||Standard Deviation|Mean
2796970|NCT00544557|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52|Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796971|NCT00544557|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52|Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796972|NCT00544557|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52|Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796973|NCT00544557|Secondary|Change From Baseline in Lateral Lumbar Flexion at Week 52|Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||cm||Standard Deviation|Mean
2796974|NCT00544557|Secondary|Change From Baseline in Occiput-to-Wall Distance at Week 52|Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘n' signifies participants evaluable for this measure at given time points.|||centimeter (cm)||Standard Deviation|Mean
2797004|NCT00543803|Secondary|Summary of Change From Baseline in CD4+ Count to Last Value on Treatment||from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||(cells) / mm^3||Inter-Quartile Range|Median
2797005|NCT00543803|Secondary|Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment|For calculation of this measure switch patients are included in the total which had no viral load decrease.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||(log10 copies) / ml||Inter-Quartile Range|Median
2796975|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796976|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.|||units on a scale||Standard Deviation|Mean
2796977|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity||Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.|||percentage of participants|||Number
2796978|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.|||percentage of participants|||Number
2796979|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 52|Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2796980|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 26|Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 26|Effectiveness population: all treated participants greater than or equal to (>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2796981|NCT00544544|Secondary|Clinical Global Impression Scale|The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
2796982|NCT00544544|Secondary|Young Mania Rating Scale|The Young Mania Rating Scale is a clinician-rated scale that measures the severity of mania symptoms. The 11 items measures are elevated mood, increased motor activity, sexual interest, sleep, irritability, speech, language-thought disorder, thought content, aggressive behavior, appearance, and insight. Minimum score is zero and maximum score is 60. Higher scores represent more severe mania symptoms.|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
2796983|NCT00544544|Secondary|Montgomery Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale is a clinician-rated scale that measures the severity of depression symptoms. The 10 items measured are apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Minimum score is zero and maximum score is 60. Higher scores represent more severe depressive symptoms.|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
2796984|NCT00544544|Primary|Change in Hamilton Depression Rating Scale|The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.|Baseline (week 0) - week 6||||units on a scale||95% Confidence Interval|Mean
2796985|NCT00544440|Secondary|Number of Participants With Change in Markers of Bone Metabolism||Week 8|Data was reported in individual participant listings but not summarized due to statistical constraints.||||||
2796986|NCT00544440|Primary|Difference in Bone Marrow Testosterone Levels Between Participants With and Without Serum Prostate Specific Antigen Decline||Week 8|Since there were too few participants with any detectable bone marrow testosterone, this analysis was not performed.||||||
2796987|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.|||Number of Participants|||Number
2797309|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population||Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2796991|NCT00544076|Secondary|SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups|Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire.|At 1, 3, 6, 9, 12, and 18 months|patients with shim scores at 1 month|||units on a scale||Full Range|Median
2796992|NCT00544076|Secondary|Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra|Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months|At 6 and 18 months|patients who were evaluated at 6 months, 18 months|||Participants|||Count of Participants
2796993|NCT00544076|Primary|Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months|Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test|12 months following BNS-RAP|These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point.|||Participants|||Count of Participants
2796994|NCT00543985|Secondary|Change in Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min) Measured in all participants immediately following treadmill stress test.|12 weeks|This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.||||||
2796995|NCT00543985|Secondary|Mean Resting Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min). Measured in all participants prior to treadmill stress test.|12 weeks|This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.||||||
2796996|NCT00543985|Primary|Post-exercise E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants immediately following treadmill stress test.|12 weeks|The echo results from all subjects were analyzed at rest and following maximal exercise testing.|||ml/min/kg||Standard Error|Mean
2796997|NCT00543985|Primary|Mean Resting E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants prior to treadmill stress test.|12 weeks|The echo results from all subjects were analyzed at rest and following maximal exercise testing.|||ml/min/kg||Standard Error|Mean
2796998|NCT00543855|Primary|Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)|"J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.~ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and Week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Score on a scale||Standard Deviation|Mean
2796999|NCT00543855|Primary|Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)|"CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from markedly improved to markedly worse. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Percentage of Participants|||Number
2797000|NCT00543855|Primary|Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Score on a scale||Standard Deviation|Mean
2797001|NCT00543855|Primary|Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.|||Score on a scale||Standard Deviation|Mean
2797002|NCT00543803|Secondary|Investigator's Global Clinical Assessment of Patient General Health Status|Investigators opinion of patients general health condition at baseline versus last evaluation on treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||participants|||Number
2797003|NCT00543803|Secondary|Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator|Total number of patients with investigator defined non-serious drug-related AEs was reported.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||participants|||Number
2797011|NCT00543803|Primary|Summary of Change From Baseline in Creatinine to Last Value on Treatment|The change in Creatinine from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||mg/dl||Inter-Quartile Range|Median
2797012|NCT00543803|Primary|Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment|The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||IU/L||Inter-Quartile Range|Median
2797013|NCT00543803|Primary|Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment|The change in asparate aminotransferase (AST) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||IU/L||Inter-Quartile Range|Median
2797014|NCT00543803|Primary|Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment|The change in alanine aminotransferase (ALT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.|||IU/L||Inter-Quartile Range|Median
2797015|NCT00543764|Primary|Operative Time|Length of Time in surgery|3 years||||hours||95% Confidence Interval|Mean
2797016|NCT00543725|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The Intent-to-Treat analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome."|||Participants|||Number
2797017|NCT00543725|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||cells per microliter||95% Confidence Interval|Mean
2797018|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 96. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797019|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797020|NCT00543725|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per mL at the last on-treatment post-Week 96 visit.|Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz|Participants with at least 1 Post-Week 96 visit were included in the analysis.|||Participants|||Number
2797021|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797022|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797023|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/mL in the Wk 48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/mL and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797094|NCT00543309|Secondary|Resource Utilization: Hours of Mechanical Ventilation Until Initial Extubation|Hours of mechanical ventilation until initial extubation following the Fontan operation.|From Fontan operation until initial extubation, assessed during initial CICU stay, up to 30 days.||||hours||Full Range|Median
2797024|NCT00543725|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797025|NCT00543569|Secondary|Gastrointestinal Symptom Rating Scale Scores Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"|||units on a scale||Standard Deviation|Mean
2797026|NCT00543569|Secondary|Gastrointestinal Quality of Life Index Score Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"|||units on a scale||Standard Deviation|Mean
2797027|NCT00543569|Secondary|Percentage of Participants With Treatment Failure at Month 6 and 12|Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797028|NCT00543569|Secondary|Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12|All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797029|NCT00543569|Secondary|Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12|"Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.~The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797030|NCT00543569|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12|Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797031|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.~Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set|||participants|||Number
2797032|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection Assessed by Local Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.~Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set|||participants|||Number
2797033|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Central Review|The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer|||days||Full Range|Median
2797034|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Local Review|The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by local review|||days||Full Range|Median
2797035|NCT00543569|Secondary|Time to First BCAR Assessed by Central Review|The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR as assessed by the central reviewer|||days||Full Range|Median
2797095|NCT00543309|Secondary|Renal Function: Maximum Change in Serum Creatinine||14 days after surgery||||mg/dL||Full Range|Median
2797036|NCT00543569|Secondary|Time to First BCAR Assessed by Local Review|The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR assessed by local review|||days||Full Range|Median
2797037|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797038|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up.|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797039|NCT00543569|Secondary|Change From Week 4 in Serum Creatinine at Month 6 and 12||Week 4 and Month 6 and 12|"Full analysis set with available data at Week 4. N indicates participants with available data at each time point."|||mg/dL||Standard Deviation|Mean
2797040|NCT00543569|Secondary|Change From Week 4 in GFR by Iothalamate Clearance at Month 6|The glomerular filtration rate was measured directly using iothalamate clearance.|Week 4 and Month 6|"Full analysis set with available data at Week 4. N indicates participants with available data at Week 4 and Month 6."|||mL/min per 1.73 m^2||Standard Deviation|Mean
2797041|NCT00543569|Secondary|Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12|The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.|Week 4, Month 6 and Month 12|"Full analysis set with available data at Week 4. N indicates the number of participants with available data at each time point."|||mL/min per 1.73 m^2||Standard Deviation|Mean
2797042|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797043|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797044|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797045|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797046|NCT00543569|Secondary|Graft Survival at Month 6 and Month 12|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797047|NCT00543569|Secondary|Patient Survival at Month 6 and Month 12|"Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797048|NCT00543569|Primary|Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set|||percentage of participants||90% Confidence Interval|Number
2797049|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 61: 28 days postdose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2797096|NCT00543309|Secondary|Renal Function: Urine Output|Volume of urine in mL/kg per day|first 24 hours CICU admit||||mL/kg per day||Full Range|Median
2797050|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 60 + 1 week: Day 7 postdose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2797051|NCT00543543|Secondary|Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|4 weeks postdose 3|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range|||Percentage of participants||95% Confidence Interval|Number
2797052|NCT00543543|Secondary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection|Combined Incidence of HPV Type 31/33/45/52/58-related persistent infection as determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. Persistent infection was defined as infection detected in samples from >=2 consecutive visits 6 months (+/-1 month visit window) or longer apart. Incidence was defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.|||Cases per 10,000 person-years follow-up|||Number
2797053|NCT00543543|Primary|Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event.|Up to Month 6|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
2797054|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be definitely related, probably related, or possibly related to the study drug is defined as a vaccine-related AE."|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
2797055|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|Up to Day 15 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
2797056|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Injection-site Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|Up to Day 5 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
2797057|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up|||Percentage of participants|||Number
2797058|NCT00543543|Other Pre-specified|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.|Month 60: predose 4 in the Extension Study (Cohort 1)|All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2797097|NCT00543309|Secondary|Cardiovascular: Peak Lactate Level||Initial 24 hours in CICU||||mEq/liter||Full Range|Median
2797098|NCT00543309|Secondary|Cardiovascular: Peak Inotrope Score|"Peak Inotrope Score = Doses of dopamine in mcg/kg/minute + dobutamine in mcg/kg/minute + (epinephrine in mcg/kg/minute x 100).~The lowest (best) possible Peak Inotrope Score = 0 dose equivalents. There is no maximum Peak Inotrope Score."|Initial 24 hours in CICU||||dose equivalents||Full Range|Median
2797099|NCT00543309|Secondary|Cardiovascular: Arrhythmia|arrhythmia lasting >30 seconds or requiring treatment|Postoperative day (POD) #0 through 5||||Participants|||Count of Participants
2797059|NCT00543543|Primary|Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.|4 weeks postdose 3 in the base study|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2797060|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.|||Cases per 10,000 person-years follow-up|||Number
2797061|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|From Day 1 until >=30 cases accumulate, up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.|||Cases per 10,000 person-years follow-up|||Number
2797062|NCT00543439|Secondary|Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): Routine Prophylaxis Therapy|"LETE in prophylaxis setting if there was a spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of study drug (which was not used to treat a bleed) in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose [a dose less than that prescribed in participant's regimen], known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for the bleed in the opinion of the investigator. Therefore, LETE in the prophylaxis setting was the occurrence of a bleed. For reporting arm: Moroctocog alfa (AF-CC), OD and RP Cohort: RP Therapy 25 IU/kg, cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2797063|NCT00543439|Secondary|Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): On Demand Therapy|"LETE occurs in OD setting if participant recorded 2 successive No Response (no improvement at all between infusions, or condition worsens) ratings after 2 successive infusions of study drug. Infusions must have been given within 24 hours (hr) of each other for treatment of same bleeding event in absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of >4 hr between onset of bleed to infusion, delay of >24 hr before administration of a follow-up infusion, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator. For reporting arm: Moroctocog alfa (AF-CC), OD and RP Cohort: RP Therapy 25 IU/kg, cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2797064|NCT00543439|Secondary|Number of Participants With Confirmed FVIII Inhibitor Development|Confirmed FVIII inhibitors were defined as a neutralizing antibody to FVIII with a titer value of greater than or equal to (>=) 0.6 Bethesda units (BU) per millimeter in a sample assayed using the Nijmegen assay at the central laboratory.|Day 1 up to Month 24|Analysis population included all participants for whom legal acceptable representative had signed informed consent/assent form and who received 1 dose of moroctocog alfa (AF-CC) and were at risk for confirmed FVIII inhibitor development.|||Participants|||Count of Participants
2797065|NCT00543439|Secondary|Number of Participants With Treatment-Related Adverse Events|A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. All participants in the study received moroctocog alfa-(AF-CC). Adverse events were not collected separately for each intervention for the participants. All participants were properly combined for the analysis and was regardless of the regimen they were following at the time, and regardless of OD or RP cohort.|Day 1 up to Month 25|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form and were analyzed for safety.|||Participants|||Count of Participants
2797066|NCT00543439|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity|AE is untoward medical occurrence in clinical investigation participant administered product or medical device;event need not necessarily had causal relationship with treatment or usage.Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 25 months)that were absent before treatment or that worsened relative to pretreatment state.AEs were classified into following on basis of severity:1)mild = did not interfere with participant's usual function;2)moderate=interfered to some extent with participant's usual function;3)severe=interfered significantly with participant's usual function;4)life threatening=AE required discontinuation of study drug,participant was at immediate risk of death.All participants in study received AF-CC.AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis,regardless of regimen were following at time,regardless of OD or RP cohort.|Day 1 up to Month 25|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form and were analyzed for safety. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2797067|NCT00543439|Secondary|Mean Residence Time (MRT) of Factor VIII Activity|MRT was calculated as AUMCinf /AUCinf-TI/2, where AUMCinf is the area under the moment curve from time zero to infinity and TI is the duration of infusion.|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2797068|NCT00543439|Secondary|Steady-State Volume of Distribution (Vss) of Factor VIII Activity|Volume of distribution is defined as the theoretical volume in which the total amount of FVIII would need to be uniformly distributed to produce the observed plasma concentration of FVIII. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.|||Milliliter per kilogram||Geometric Coefficient of Variation|Geometric Mean
2797069|NCT00543439|Secondary|Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) of Factor VIII Activity|Area under the FVIII activity -versus-time curve from time zero to the time of the last quantifiable concentration.|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.|||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2797070|NCT00543439|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Factor VIII Activity|Area under FVIII activity-time profile from time zero extrapolated to infinite time. AUCinf is reported in units: international units*hour per milliliter (IU*hour/mL).|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.|||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2797071|NCT00543439|Secondary|Maximum Concentration of Factor VIII Activity|Maximum concentration of FVIII activity was measured in international units per milliliter (IU/mL).|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2797072|NCT00543439|Secondary|Incremental Recovery of Factor VIII Activity|Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of moroctocog alfa (AF-CC) administered per kilogram of body weight of participant. It was measured in international units per deciliter per international units per kilogram ([IU/dL]/[IU/kg]).|Day 1, Month 6|Analysis population included all participants for whom legal acceptable representative had signed informed consent/assent form, were in non-bleeding state, participated in single PK assessment at start of study and for whom an adequate PK profile had been obtained. “Number analyzed” signifies participants evaluable at specified time points.|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2797073|NCT00543439|Secondary|Clearance (CL) of Factor VIII Activity|Clearance is a measure of the volume of plasma from which FVIII activity is removed per unit time. It was reported in units milliliter per hour per kilogram (mL/hr/kg).|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single PK assessment at the start of the study and for whom an adequate PK profile had been obtained.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2797074|NCT00543439|Secondary|Terminal Phase Half Life (t1/2) of Factor VIII (FVIII) Activity|Plasma decay half-life is the time measured for the FVIII activity to decrease by one half.|0.5, 8, 24, 28 and 32 hours post dose on Day 1|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form, were in a non bleeding state, participated in a single pharmacokinetic (PK) assessment at the start of the study and for whom an adequate PK profile had been obtained.|||Hour||Standard Deviation|Mean
2797100|NCT00543309|Secondary|Cardiovascular: Cardiac Index|Cardiac index measured using Fick principle with measured oxygen consumption.|Postoperative hour #8|Study patients for whom cardiac index measurements were available.|||L/min/m2||Full Range|Median
2797101|NCT00543309|Secondary|Cardiovascular: Cardiac Index|Cardiac index measured using Fick principle with measured oxygen consumption.|Postoperative hour #1|Study patients for whom cardiac index measurements were available.|||L/min/m2||Full Range|Median
2797102|NCT00543309|Primary|Days Alive and Out of the Hospital Within 30 Days of Surgery.||30 days||||days||Full Range|Median
2797103|NCT00543296|Secondary|Number of Eyes With Increased Intraocular Pressure||52 weeks||||eyes|Participants||Number
2797075|NCT00543439|Secondary|Mean of Total Number of Infusions of Moroctocog Alfa (AF-CC) Received Per Week to Assess Compliance: Routine Prophylaxis Therapy|"Participants' compliance to their assigned prophylaxis regimen was measured by following: a) number of infusions received per week and b) dose received. In this outcome measure mean of total number of infusions of moroctocog alfa (AF-CC) received by participants per week is reported. For reporting arm: Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Infusions per week||Standard Deviation|Mean
2797076|NCT00543439|Secondary|Mean of Total Number of Days Participants Exposed to Moroctocog Alfa (AF-CC): Routine Prophylaxis Therapy|"For reporting arm: Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg, cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Days||Standard Deviation|Mean
2797077|NCT00543439|Secondary|Mean of Total Number Moroctocog Alfa (AF-CC) Infusions Received: Routine Prophylaxis Therapy|"In this outcome measure mean of total number of infusions of moroctocog alfa (AF-CC) received by participant is reported. For reporting arm: Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg, cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Infusions||Standard Deviation|Mean
2797078|NCT00543439|Secondary|Mean Routine Prophylaxis Dose (IU/kg) of Moroctocog Alfa (AF-CC) Received: Routine Prophylaxis Therapy|"Mean RP dose (by weight) for each participant was calculated as his total moroctocog alfa (AF-CC) consumption (in IU) divided by weight (in kg). For reporting arm: Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg, cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||IU/kg||Standard Deviation|Mean
2797079|NCT00543439|Secondary|Number of Participants Requiring Prophylaxis Regimen Escalation: Routine Prophylaxis Therapy|"During prophylaxis, criteria for prophylaxis regimen escalation are the occurrence, over a 4-week duration (and in the absence of a confirmed FVIII inhibitor), of (a) 2 or more spontaneous bleeds into a major joint and/or target joint, or (b) 3 or more spontaneous bleeds (consisting of joint bleeds and/or significant soft tissue/muscle or other site bleeds). If either criterion was met, the participant was escalated to a more intense prophylaxis regimen of 45 IU/kg, administered every other day. Participant who meet dose escalation criteria while on prophylaxis regimen of 45 IU/kg, were escalated to a higher intensity regimen designated by the investigator. Significant spontaneous bleeds were those that led to a transient or persistent loss of function. For reporting arm: Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg, cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2797080|NCT00543439|Secondary|Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy|"In this outcome measure number of treated spontaneous bleeds are reported according to the time interval between bleed onset and prior moroctocog alfa (AF-CC) routine prophylaxis dose. Following time intervals used to report this outcome measure: lesser than or equal to (<=) 24 hours, greater than (>) 24 hours to <=48 hours, >48 hours to <=72 hours, >72 hours. For reporting arm: Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported."|Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|Analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form and who reported a spontaneous bleeding episode following a routine prophylaxis dose.|||Bleeds|bleeds||Number
2797104|NCT00543296|Secondary|Number of Participant's Eye Requiring Adjunctive Therapy|Adjunctive Therapy needed to control inflammation in the implanted eye|5 years|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy|||participant's eyes|Participants||Number
2797105|NCT00543296|Secondary|Percentage of Eyes With Improvement in Visual Acuity|Visual acuity was improved by two or more lines from baseline.|baseline to 52 weeks|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy|||percentage of eyes improved|Participants||Number
2797106|NCT00543296|Primary|Number of Eyes With Inflammation Recurrence|Number of eyes with inflammation recurrence|5 years||||eye with inflammation|Participants||Number
2797173|NCT00542750|Primary|Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period|Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.|one year||||Participants|||Number
2797081|NCT00543439|Secondary|Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort)|Number (no.) of bleeds treated are reported on basis of response to first infusion of study drug, at 4-point scale: excellent, good, moderate, no response. Excellent:definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good:definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate:probable or slight improvement starting after 8 hr following infusion,at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as:Data Not Recorded. Total no. of first infusions may not be equal to total no. of bleeds if bleed was: missing start date/dose information or treated initially with non-study FVIII.|Day 1 up to Month 24|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Bleeds|bleeds||Number
2797082|NCT00543439|Secondary|Mean of Moroctocog Alfa (AF-CC) Infusions Administered To Treat Bleeding Episode: All Participants|In this outcome measure, the mean of total number of moroctocog alfa (AF-CC) on-demand infusions administered to treat each bleeding episode was reported, regardless of participant cohort or period during which it occurred.|Day 1 up to Month 24|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Infusions|bleed|Standard Deviation|Mean
2797083|NCT00543439|Secondary|Mean Annualized Bleed Rate (ABR) by Treatment: Routine Prophylaxis Cohort|ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).|Day 1 up to Month 24 (RP Cohort, Period 1 and Period 2)|"ITT analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Bleeds per year||Standard Deviation|Mean
2797084|NCT00543439|Primary|Mean Annualized Bleed Rate (ABR) by Treatment: On Demand Cohort|ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).|Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)|"Intent-to-treat (ITT) analysis population included all participants for whom a legal acceptable representative had signed the informed consent/assent form. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Bleeds per year||Standard Deviation|Mean
2797085|NCT00543400|Primary|Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.||30 days||||patients experiencing an event|||Number
2797086|NCT00543387|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were AEs considered related to study drug that prevented escalation of the drug dose. Hematologic DLTs included any Grade 5 hematologic toxicity, Grade 4 neutropenia lasting for ≥7 days in duration, Grade 3 or Grade 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and Grade 4 thrombocytopenia (≤25.0 x 10^9/L). Non-hematologic DLT was defined as any Grade 3, 4, or 5 non-hematologic toxicity, with the specific exceptions of: Grade 3 nausea or Grade 3 vomiting, Grade 3 diarrhea, or Grade 3 dehydration occurring in the setting of inadequate compliance with supportive care and lasting for <48 hours, alopecia, inadequately treated hypersensitivity reactions, or Grade 3 elevated transaminases of ≤1 week in duration. Any drug-related AE leading to a dose modification of MK-5108, or any unresolved drug-related toxicity persisting>6 weeks, was also considered a DLT.|Day 1 to Day 21 of study treatment (Cycle 1 for Panel 1, Panel 2, or Crossover)|All participants that received one or more doses of study medication. Participants who received MK-5108 monotherapy in Panel 1 and then crossed over to receive combination treatment in Panel 2 (Crossover) were included in both respective treatment groups and DLTs were reported according to treatment received.|||Participants|||Count of Participants
2797087|NCT00543387|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported for each dose level group.|From Day 1 of study treatment until 30 days following the last dose of study treatment (up to 577 days)|All participants that received one or more doses of study medication. Four participants who received MK-5108 monotherapy in Panel 1 and then crossed over to receive combination treatment in Panel 2 (Crossover) were included in both respective treatment groups and AEs were reported according to treatment received.|||Participants|||Count of Participants
2797088|NCT00543309|Secondary|N-terminal Pro-brain Natriuretic Peptide Levels|N-terminal pro-brain natriuretic peptide levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.|Preoperative baseline to 24 hours after CICU admission||||fmol/mL||Full Range|Median
2797089|NCT00543309|Secondary|Epinephrine Levels|Plasma epinephrine levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.|Preoperative baseline to 24 hours after CICU admission||||ng/mL||Full Range|Median
2797090|NCT00543309|Secondary|Plasma Norepinephrine Levels.|Plasma norepinephrine levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.|Preoperative baseline to 24 hours after CICU admission||||ng/mL||Full Range|Median
2797091|NCT00543309|Secondary|Resource Utilization: Days Alive and Out of Hospital Within 180 Days of Surgery|Days the patient was alive and out of hospital within the 180 days after Fontan surgery|180 days||||days||Full Range|Median
2797092|NCT00543309|Secondary|Resource Utilization: Chest Tube Days|Days during which one or more chest tubes were in place following the Fontan operation.|From Fontan operation until final chest tube removed, assessed during postoperative hospitalization, up to 90 days.||||days||Full Range|Median
2797107|NCT00543140|Secondary|Change in SF-36 Health Survey Mental Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||Unitless scale ranging 0 to 100||95% Confidence Interval|Mean
2797108|NCT00543140|Secondary|Change in SF-36 Health Survey Physical Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||unitless scale ranging 0 to 100||95% Confidence Interval|Mean
2797109|NCT00543140|Secondary|Percent Change in Excess Body Weight at 5 Years Post-implant||5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||percentage of excess body weight||95% Confidence Interval|Mean
2797110|NCT00543140|Secondary|Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.|The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.|||percentage||95% Confidence Interval|Mean
2797111|NCT00543140|Primary|Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.|"A reoperation was identified by satisfying all of the following criteria:~Is an SAE or is the action taken as the result of an SAE;~Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device;~Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and~Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device."|5 years|Consists of subjects who had a device implanted under protocol CI-07-0006 and subjects implanted under protocol CI-02-0006 and subsequently enrolled under protocol CI-06-0001.|||percentage of subjects||95% Confidence Interval|Number
2797112|NCT00543127|Secondary|Time to Recurrence (TR) Event|"TR event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.~TR event is defined as the evidence of breast cancer recurrence (local and/or distant recurrence of breast cancer, does not include second primary malignancies or deaths from any cause)."|Up to 5 years||||Participants|||Count of Participants
2797113|NCT00543127|Secondary|Overall Survival (OS) Event|"OS event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.~OS event is defined as the death from any cause."|Up to 5 years|Statistical analyses of the efficacy outcome variables will be based on an intent-to-treat (ITT) method and will include all randomised patients.|||Participants|||Count of Participants
2797114|NCT00543127|Secondary|Breast Cancer Specific Survival (BCsS) Events|"BCsS events has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to BCsS in patients treated with anastrozole for 5 years.~BCsS event is defined as the death from breast cancer."|Up to 5 years|Analyses of the efficacy outcome variables will be based on an intent-to-treat (ITT) method and will include all randomised patients.|||Participants|||Count of Participants
2797115|NCT00543127|Primary|Disease Free Survival (DFS) Events|"Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.~DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause."|Up to 5 years|Primary statistical analyses of the efficacy outcome variables will be based on an intent-to-treat (ITT) method and will include all randomised patients|||Participants|||Count of Participants
2797116|NCT00543101|Secondary|Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)|Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.|24 weeks||||Units on a Scale (+3 to -3)||Full Range|Median
2797117|NCT00543101|Secondary|Lipid Fraction Results, Mean of the Change From Baseline to Week 24.|We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.|baseline and 24 weeks||||mg/dL|||Number
2797118|NCT00543101|Secondary|Economic Impact of a Substitution of Dual Boosted PIs With DRV/r|To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.|48 weeks||||US dollars savings per month|||Number
2797119|NCT00543101|Primary|The Percentage of Participants With Successful Virologic Suppression|Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.|24 weeks||||Percentage of Participants|||Number
2797120|NCT00543062|Other Pre-specified|Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)|A thorough QT/QTc study may be considered to have demonstrated assay sensitivity if 1 or more of the lower 95% CI values exceeds 5 msec|1, 1.5, 2, 2.5, 3, 5 hours|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between moxifloxacin and placebo exposures per ICH Guideline E14 for a thorough QT study.|||milliseconds||95% Confidence Interval|Least Squares Mean
2797371|NCT00541099|Secondary|Overall Survival|Overall survival using Kaplan-Meier method.|4 weeks after removal from study or until death||||months||95% Confidence Interval|Median
2797121|NCT00543062|Secondary|Numbers and % of Subjects With QTcI Change > 60 ms|Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms at any of the outcome measure time points|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between active and placebo exposures per ICH Guideline E14 for a thorough QT/QTc study.|||Participants|||Count of Participants
2797122|NCT00543062|Secondary|Numbers and % of Subjects With QTcI Change > 30 ms|Numbers and Percents of Subjects with QTcI increase from baseline exceeding 30 ms at any of the outcome measure time points|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between active and placebo exposures per ICH Guideline E14 for a thorough QT/QTc study.|||Participants|||Count of Participants
2797123|NCT00543062|Secondary|Numbers and % of Subjects With QTcI > 480 ms|Numbers and Percents of Subjects with QTcI exceeding 480 ms at any of the outcome measure time points|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between active and placebo exposures per ICH Guideline E14 for a thorough|||Participants|||Count of Participants
2797124|NCT00543062|Secondary|Numbers and % of Subjects With QTcI > 450 ms|Numbers and Percents of Subjects with QTcI exceeding 450 ms|24 hours|QT Population (placebo and prochlorperazine only)|||Participants|||Count of Participants
2797125|NCT00543062|Secondary|QTcI Versus Prochlorperazine Concentration|QTcI @ median prochlorperazine concentration (3.75 mcg/mL) based on linear and nonlinear regression of QTcI versus time matched serum prochlorperazine concentrations|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr|"846 paired QTcI and prochlorperazine concentration pairs from 42 subjects receiving prochlorperazine (5 or 10 mg)~Each measure was based on the individual (within subject) corrected differences between prochlorperazine and placebo exposures per ICH Guideline E14 for a thorough QT study."|||milliseconds||90% Confidence Interval|Least Squares Mean
2797126|NCT00543062|Primary|Maximum Effect of Inhaled Prochlorperazine on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo|Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for treatment at 11 post-inhalation times.|1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between prochlorperazine and placebo exposures per ICH Guideline E14 for a thorough QT/QTc study.|||milliseconds||90% Confidence Interval|Least Squares Mean
2797127|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG|AUCτ = Area under the concentration-time curve during regular dosing interval;|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population. 7 subjects were missing data for AUCτ.|||day x g/L||Standard Deviation|Mean
2797128|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG|AUC_last = Area under the concentration-time curve until last measured concentration.|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.|||day x g/L||Standard Deviation|Mean
2797129|NCT00542997|Other Pre-specified|Timepoint of Maximum Concentration (Tmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.|||day||Full Range|Median
2797130|NCT00542997|Other Pre-specified|Maximum Concentration (Cmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.|||g/L||Standard Deviation|Mean
2797131|NCT00542997|Secondary|Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment|The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.~The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."|||days/subject/year|Participants||Number
2797132|NCT00542997|Secondary|Annual Rate of the Number of Days of Hospitalization Due to Infections|The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.~The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."|||days/subject/year|Participants||Number
2797133|NCT00542997|Secondary|Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).|||days/subject/year|Participants||Number
2797134|NCT00542997|Secondary|Annual Rate of Infection Episodes|The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).|||episodes/subject/year|Participants|95% Confidence Interval|Number
2797135|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.~The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Per Protocol Efficacy (PPE) population analysis. The PPE population included all subjects who completed the 28-week efficacy period according to protocol.|||SBIs/subject/year|Participants||Number
2797136|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.~The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).|||SBIs/subject/year|Participants||Number
2797137|NCT00542997|Primary|Total Serum IgG Trough Levels|Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.|Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12). For 2 subjects in the ITT population, the pre-study treatment IgG trough levels were not available.|||g/L||Standard Deviation|Mean
2797138|NCT00542971|Secondary|Number of Participants With Complete Response|Complete response was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L platelets in the peripheral blood (PB).|Baseline to 2 years or disease progression.||||Participants|||Number
2797139|NCT00542971|Primary|Maximum Tolerated Dose (MTD)|MTD is dose level where grade 3-4 sorafenib-attributable toxicity in <2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.|Twice a week for first two 28 day cycles|10 participants were treated with escalating doses of sorafenib with chemotherapy to establish the feasibility of the combination.|||milligrams/twice a day (BID)|||Number
2797140|NCT00542880|Secondary|The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Deviation|Mean
2797141|NCT00542880|Secondary|Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Deviation|Mean
2797142|NCT00542880|Secondary|Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||units on a scale||Standard Deviation|Mean
2797143|NCT00542880|Secondary|Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797144|NCT00542880|Secondary|Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797145|NCT00542880|Secondary|Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797172|NCT00542789|Primary|Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period|The absence of gastric and/or duodenal ulcer throughout the treatment period|each visit up to 24 weeks|Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively.|||Participants|||Number
2797146|NCT00542880|Secondary|Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797147|NCT00542880|Secondary|Change in PEF From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
2797148|NCT00542880|Secondary|Change in PEF From Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
2797149|NCT00542880|Secondary|FEV1 Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797150|NCT00542880|Secondary|FEV1 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797151|NCT00542880|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.|||Liters||Standard Deviation|Mean
2797152|NCT00542880|Secondary|PEF Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
2797153|NCT00542880|Secondary|PEF 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minute||Standard Deviation|Mean
2797154|NCT00542880|Secondary|PEF Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||Liters/minutes||Standard Deviation|Mean
2797155|NCT00542880|Primary|Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose|The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.|||liters/minute||Standard Deviation|Mean
2797156|NCT00542828|Secondary|Number of Participants With a Marrow Remission|This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797157|NCT00542828|Secondary|Number of Participants With a Cytogenetic Response|This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797158|NCT00542828|Secondary|Number of Participants With Transformation to Acute Myeloid Leukemia|This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2800040|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
2797159|NCT00542828|Secondary|Number of Participants With Progression-free Survival|This is a measure of a progression-free survival which is defined as the time from the participant's first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797160|NCT00542828|Secondary|Number of Participants With a Relapse Following Overall Remission|This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence.|36 months|Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point)||||||
2797161|NCT00542828|Secondary|Number of Participants With a Relapse Following HI|This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797162|NCT00542828|Secondary|Number of Participants With Duration of Transfusion Independence|This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797163|NCT00542828|Secondary|Number of Participants Who Achieved Transfusion Independence|This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797164|NCT00542828|Secondary|Duration of Disease Remission|This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797165|NCT00542828|Secondary|Number of Participants Who Achieved Disease Remission|Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797166|NCT00542828|Secondary|Number of Participants With Duration of HI|This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).||||||
2797167|NCT00542828|Primary|Number of Participants Who Achieved Hematologic Improvement (HI)|This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.|12 months|Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination.|||participants|||Number
2797168|NCT00542815|Secondary|The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer|Percent Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.|||percentage change of LDL-cholesterol||Standard Deviation|Mean
2797169|NCT00542815|Primary|The Change in Serum Phosphorus for MCI-196 and Sevelamer|Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.|||mg / dL||Standard Deviation|Mean
2797170|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment|up to 12 weeks||||Participants|||Number
2797171|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment|up to 4 weeks||||Participants|||Number
2797174|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||percentage of subjects|||Number
2797175|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||percentage of subjects|||Number
2797176|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||percentage of subjects|||Number
2797177|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L|"Number of symptoms only hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself."|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||episodes|||Number
2797178|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L|Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||episodes|||Number
2797179|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - All Episodes|Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.|||episodes|||Number
2797180|NCT00542620|Secondary|Body Mass Index (BMI) Z Score|Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||Z-score||Standard Deviation|Mean
2797181|NCT00542620|Secondary|Weight Z Score|Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||Z-score||Standard Deviation|Mean
2797182|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
2797183|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
2797184|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
2797185|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
2797186|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol/L||Standard Deviation|Median
2797187|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects|||hours||Standard Deviation|Median
2797188|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects|||pmol.h/L||Standard Deviation|Median
2797189|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
2797190|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
2797191|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol/L||Standard Deviation|Median
2797192|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects|||hours||Standard Deviation|Median
2797193|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.|||pmol.h/L||Standard Deviation|Median
2797194|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol.h/L||Standard Deviation|Median
2797195|NCT00542620|Secondary|Pharmacokinetics: Tmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||hours||Standard Deviation|Median
2797196|NCT00542620|Secondary|Pharmacokinetics: Cmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||pmol/L||Standard Deviation|Median
2797197|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.|||mg/dL||Standard Deviation|Mean
2797198|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mg/dL||Standard Deviation|Mean
2797199|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mg/dL||Standard Deviation|Mean
2797200|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mg/dL||Standard Deviation|Mean
2797201|NCT00542620|Secondary|Fructosamine||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||mmol/L||Standard Deviation|Mean
2797202|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the ITT (Intention-to-Treat) set|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.|||percentage of total haemoglobin||Standard Deviation|Mean
2797240|NCT00542178|Secondary|Cataract Extraction||Measured at Year 4|Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction.|||Participants|||Count of Participants
2797203|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol (PP) set|Week 0 and Week 8|Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections.|||percentage of total haemoglobin||Standard Deviation|Mean
2797204|NCT00542542|Primary|Proportion of Participants With No Pain Immediately After Surgery|Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).|Starting immediately after surgery, every 2 hours till the 6th hour following surgery|Analysis was not possible from data collected due to reporting inconsistencies.||||||
2797205|NCT00542490|Secondary|Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy||2 years||||Participants|||Count of Participants
2797206|NCT00542490|Primary|Number of Patients With Progression-free Survival at 2 Years||2 years|19 of the 23 patients completed VCB and 3 cycles of chemotherapy|||Participants|||Count of Participants
2797207|NCT00542425|Secondary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.|12 months|The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48.|||Percent change from baseline||Standard Deviation|Mean
2797208|NCT00542425|Secondary|Change in Bone Mineral Density, Total Hip.|Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
2797209|NCT00542425|Secondary|Change in Bone Mineral Density, Femoral Neck.|Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
2797210|NCT00542425|Primary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
2797211|NCT00542425|Primary|Change in Marker of Bone Metabolism, PINP|PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24.|||Percent change from baseline||Standard Deviation|Mean
2797212|NCT00542386|Secondary|The Incidence of Adverse Events||12 weeks|||||||
2797213|NCT00542386|Secondary|The Change in Ca x P Ion Product||12 weeks|||||||
2797214|NCT00542386|Secondary|The Change in Ca||12 weeks|||||||
2797215|NCT00542386|Secondary|The Change in PTH||12 weeks|||||||
2797216|NCT00542386|Secondary|The Change in Triglycerides||12 weeks|||||||
2797217|NCT00542386|Secondary|The Change in HDL-cholesterol||12 weeks|||||||
2797218|NCT00542386|Secondary|The Change in Total-cholesterol||12 weeks|||||||
2797219|NCT00542386|Primary|The Change in LDL-cholesterol|The percentage change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start of study medication.|||Percent change||Standard Deviation|Mean
2797220|NCT00542386|Primary|The Change in Serum Phosphorus|The change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start|||mg/dL||Standard Deviation|Mean
2797221|NCT00542321|Secondary|Turning-related Events|Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group|Participants were followed for the duration of time on protocol, an average of 3.5 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated)|||Events||Standard Deviation|Mean
2797222|NCT00542321|Secondary|ICU All-cause Mortality.|Death from any reason between admission and discharge from study ICU|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol)|||participants|||Number
2797223|NCT00542321|Secondary|ICU Length of Stay.|Time in days from study ICU admission to study ICU discharge or death|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol)|||Days||Inter-Quartile Range|Median
2797224|NCT00542321|Secondary|Mechanical Ventilation Duration.|Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation|Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated)|||Days||Standard Deviation|Mean
2797225|NCT00542321|Primary|Incidence of Pulmonary Complications.|Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.|Participants were followed for the duration of ICU stay, an average of 10 days.|Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated)|||participants|||Number
2797226|NCT00542308|Secondary|Tumour Response|Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|During treatment and two weeks after end of treatment, assessed up to 21 months.|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.|||participants|||Number
2797227|NCT00542308|Primary|Overall Survival|Overall survival was defined as time from start of treatment until date of death of any cause.|From randomization until death, assessed up to 21 months|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.|||months||95% Confidence Interval|Median
2797228|NCT00542269|Secondary|Percentage of Patients Who Developed Diabetes at End of Study|A patient had diabetes if fasting plasma glucose > 7 mmol/L.|Week 12|Intent-to-treat (ITT) population: All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the primary efficacy variable.|||Percentage of patients|||Number
2797229|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/mol||Standard Error|Least Squares Mean
2797230|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/mol||Standard Error|Least Squares Mean
2797231|NCT00542269|Secondary|Change in HOMA-β From Baseline to End of Study|Homeostasis model assessment-β (HOMA-β) was defined as fasting insulin (μU/mL) x 20 / (fasting glucose (mmol/L) - 3.5).|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/L||Standard Deviation|Mean
2797232|NCT00542269|Secondary|Change in HOMA-IR From Baseline to End of Study|Homeostasis model assessment-insulin resistance (HOMA-IR) was defined as (fasting insulin [μU/mL] x fasting glucose [mmol/L]) / 22.5.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmol/L||Standard Deviation|Mean
2797233|NCT00542269|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study|Normalized was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||Percentage of patients|||Number
2797234|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmHg||Standard Error|Least Squares Mean
2797235|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmHg||Standard Error|Least Squares Mean
2797236|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.|||mmHg||Standard Error|Least Squares Mean
2797237|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12||||mmHg||Standard Error|Least Squares Mean
2797238|NCT00542191|Primary|1) Pathologic Response|Pathologic measurement post-surgery viable primary tumor mass|Upon completion therapy after surgery|Study closed to accrual - not enough participants to participate.|||Participants|||Count of Participants
2797239|NCT00542178|Secondary|Development or Progression of Macular Edema||Measured at Year 4||||Participants|||Count of Participants
2797242|NCT00542178|Primary|Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy|Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.|Measured at Year 4|The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses.|||participants|||Number
2797243|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797244|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797245|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797246|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797247|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797248|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797249|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797250|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797251|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797252|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797253|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797279|NCT00541931|Primary|Change in Fine Wrinkling|Assessed by 4 dermatologists blinded to chronological age and smoking status, on a 10-point Likert scale (min 1/max 10); lower scores indicate less wrinkling and higher scores indicate more wrinkling. Values are the average of scores given by the four raters. Change was calculated as the baseline value minus the week 12 value.|Baseline; week 12|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2797254|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797255|NCT00541970|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.|Within 30 days (Day 0-29) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797256|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797257|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|From Month 0 to Month 48.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2797258|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2797259|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2797260|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2797261|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797262|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, on subjects with available results.|||Participants|||Count of Participants
2797263|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797264|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797265|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797266|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797267|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797268|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797269|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797280|NCT00541931|Primary|Fold Change in Long Chain Fatty Acids|Peripheral blood long chain fatty acids were measured. Fold change of 1 = no difference; if metabolites decrease at week 12 from baseline, the fold change will be <1.|Baseline; Week 12|Participants completing the protocol were included in the analysis.|||Fold Change in long chain fatty acids||Full Range|Mean
2797270|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797271|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797272|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2797273|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects eligible for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2797274|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2797275|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.|At Month 3, 1 month after the second dose of vaccine or placebo|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2797276|NCT00541970|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797277|NCT00541970|Primary|Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.|||Participants|||Count of Participants
2797278|NCT00541970|Primary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2797282|NCT00541866|Secondary|Overall Survival|Overall survival is censored at the earlier of the cutoff date for analysis and the last date known to be alive for patients not known to have died.|Time between the date of first study treatment and the date of death due to any cause for upto 2 years after the end of study visit|All treated analysis set|||months||95% Confidence Interval|Median
2797283|NCT00541866|Secondary|Leukemia-free Survival (LFS)|Leukemia-free survival is censored at the last known alive date without report of relapse.|From time of the start of CR or CRp to the earliest date of relapse, commencement of reinduction therapy, or death, assessed monthly up to 2 years after the end of study visit.|All treated analysis set.|||months||95% Confidence Interval|Median
2797284|NCT00541866|Secondary|Remission Rates (CR+CRp)|"Complete remission (CR) plus CR with incomplete platelet recovery (CRp) per The IWG criteria for remission modified by Sunesis, assessed by investigator.~CR is defined as >1000 Neutrophils (ul), >100,000 Platelets (uL) and <5 BM Blasts (%); CRp is defined as >1000 Neutrophils (ul), <=100,000 Platelets (uL) and <5 BM Blasts (%); CRi is defined as >1000 Neutrophils (ul), <100,000 Platelets (uL) and <5 BM Blasts (%); Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (CR with morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse."|Monthly after the end of treatment for the first year, then every 2 months thereafter for upto 2 years|All treated set which includes all enrolled patients who received any IMP.|||Participants|||Count of Participants
2797285|NCT00541866|Primary|Incidence of Dose-Limiting Toxicity (DLT) to Determine Maximum Tolerated Dose in Schedule A and Schedule B of Dose Escalation Phase (Group 1 and Group 2)|Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.|From start of treatment (Day 1) through Induction Day 29 or the start of reinduction, whichever occurred first.|Patients experiencing a dose-limiting toxicity (DLT) during induction when treated with escalating doses of vosaroxin administered in combination with cytarabine on Days 1 and 4 in Schedule A, and with vosaroxin in escalating doses administered on Days 1 and 4 in Schedule B.|||Participants|||Count of Participants
2797286|NCT00541775|Secondary|2-hour Post-meal Glucose (PMG) at Week 18|The change from baseline is the Week 18 PMG minus the Week 0 PMG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2797287|NCT00541775|Secondary|Fasting Plasma Glucose (FPG) at Week 18|The change from baseline is the Week 18 FPG minus the Week 0 FPG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2797288|NCT00541775|Primary|Hemoglobin A1C (A1C) at Week 18|"A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.~The study hypothesis comparison was between sitagliptin versus placebo."|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
2797289|NCT00541671|Primary|Number of Patients Who Became Nauseated After IV Opiate Administration.||4 hours post opiate administration||||participants|||Number
2797290|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Participants|||Number
2797291|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104||Week 104|ITT Population|||Participants|||Number
2797292|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Participants|||Number
2797293|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52||Week 52|ITT Population|||Participants|||Number
2797294|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Participants|||Number
2797295|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population||Week 104|ITT Population.|||Participants|||Number
2797296|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Participants|||Number
2797297|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52||Week 52|ITT Population|||Participants|||Number
2797298|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797299|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797300|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797301|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population||Week 52|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797302|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797310|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797311|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797312|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797313|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797314|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population||Week 26|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797315|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population||Week 13|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797316|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797317|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population||Week 104|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797318|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797319|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population||Week 52|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797320|NCT00541658|Secondary|Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797321|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. LOCF at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797322|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population||Week 104|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797323|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. LOCF at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797324|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797325|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population||Week 26|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797326|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797327|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population||Week 104|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797328|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797329|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population||Week 52|ITT Population.|||Percent||95% Confidence Interval|Least Squares Mean
2797330|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population||Week 26|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797331|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percentage of Participants|||Number
2797332|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population|||Percentage of Participants|||Number
2797333|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.|||Percentage of Participants|||Number
2797334|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population.|||Percentage of Participants|||Number
2797335|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797336|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population||Week 104|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797337|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population||Week 52|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797338|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population||Week 26|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2797339|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797340|NCT00541658|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population||52 weeks / Endpoint|Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797341|NCT00541593|Primary|Mortality|"Number of patients who died as a result of the surgery: Death (mortality).~Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure."|One year|Patients who had the diagnosis, qualified anatomically, and were interested in the research study (and who met inclusion criteria but not exclusion criteria) were enrolled.|||participants|||Number
2797342|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for FPG.|||mg/dL||95% Confidence Interval|Least Squares Mean
2797343|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and (2) had a baseline measurement and at least one on-treatment measurement for FPG.|||mg/dL||95% Confidence Interval|Least Squares Mean
2797344|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for PMG.|||mg/dL||95% Confidence Interval|Least Squares Mean
2797345|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for A1C.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2797346|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and~(2) had a baseline measurement and at least one on-treatment measurement for PMG."|||mg/dL||95% Confidence Interval|Least Squares Mean
2797347|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks|The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.|Baseline to 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and~(2) had a baseline measurement and at least one on-treatment measurement for A1C."|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2797348|NCT00541346|Secondary|Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit|This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797349|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797372|NCT00541099|Secondary|Progression-free Survival|Progression-free survival in months via the Kaplan-Meier method|6 months when treated with combination of Avastin and weekly docetaxel|No patient showed a response, therefore all patients had 0 for PFS||||||
2797350|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797351|NCT00541346|Secondary|Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit|The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797352|NCT00541346|Secondary|Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit|The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797353|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797354|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797355|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797356|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797357|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797373|NCT00541099|Primary|Survival||6 months when treated with combination of Avastin and weekly docetaxel||||percentage of participants surviving||90% Confidence Interval|Number
2807826|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 1|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 1|on-study week 5||||ng/mL||Standard Deviation|Mean
2797358|NCT00541346|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit|This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.|||units on a scale||Standard Deviation|Mean
2797359|NCT00541307|Secondary|Device-related Major Adverse Events at 12 Months|If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months||||event|||Number
2797360|NCT00541307|Secondary|Secondary Patency|Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.|12 months||||percentage of subjects||95% Confidence Interval|Number
2797361|NCT00541307|Secondary|Primary Assisted Patency|Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.|12 months||||percentage of subjects||95% Confidence Interval|Number
2797362|NCT00541307|Secondary|Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days|If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|30 days||||participants|||Number
2797363|NCT00541307|Primary|Primary Patency at 12 Months|Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).|12 months||||percentage of subjects||95% Confidence Interval|Number
2797364|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 18|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2797365|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 12|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2797366|NCT00541229|Primary|24-hour Weighted Mean Glucose (WMG)|The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.|Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.|The per-protocol (PP) population consisted of all patients randomized who had a measurement at Day 7 in Treatment Period I and did not have any major protocol violations. Missing data were not imputed.|||mg/dL||95% Confidence Interval|Least Squares Mean
2797367|NCT00541190|Secondary|Mucociliary Clearance Rate|"Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on whole lung areas to allow comparisons with previous studies."|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.|||percentage lung clearance per hour||Standard Deviation|Mean
2797368|NCT00541190|Primary|Absorptive Clearance Rate|The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.|||percentage of DTPA absoprtion per hour||Standard Deviation|Mean
2797369|NCT00541099|Secondary|Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|1st and 2nd week of each 21 day cycle, up to six cycles.||||Adverse event|||Number
2797370|NCT00541099|Secondary|Response Rate||Every 8 weeks||||Participants|||Count of Participants
2797374|NCT00541034|Primary|Overall Objective Response|The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|2 years||||Participants|||Count of Participants
2797375|NCT00540982|Primary|Number of Participants With Grade 3 and 4 Toxicities|Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0.|3 weeks after the stop of treatment||||Participants|||Count of Participants
2797376|NCT00540982|Primary|Area Under the Curve|Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose.|2 months post treatment|Vinorelbine plasma AUC0-24 data were available for a total of 30 subjects.|||ng/ml x hr||Full Range|Median
2797377|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2797378|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2797379|NCT00540969|Primary|Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
2797380|NCT00540722|Other Pre-specified|Explore Clinical Outcome (Overall Survival) With Changes of Potential Serum Biomarkers, Baseline Tumor Protein Expression and Gene Methylation Status|Archived tumor tissue and 1 serum sample pre first dose and 1 sample anytime during week 2 of cycle 1|1 month|no data to report. Not enough archived tumor tissue and survival outcome did not warrant an analysis of the Pharmacokinetics (PK)||||||
2797381|NCT00540722|Secondary|Progression-free Survival Rate, Defined as Patient Who is Alive and Disease Progression Free at the Time of 26-week (6 Months) From First Day of the Treatment|The probability of 6-month progression-free survival will be estimated using binomial distribution.|6 months||||months||95% Confidence Interval|Median
2797382|NCT00540722|Secondary|Tumor Response Rate|"Complete response Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease Clinical status and MRI does not qualify for complete response, partial response or progression"|3 years|5 patients were not evaluable for response|||Participants|||Count of Participants
2797383|NCT00540722|Secondary|Percent of Patients With Grade 3 and 4 Adverse Events Related to Treatment|The proportion of patients with serious or life threatening (grade 3 and 4) toxicities will be estimated using NCI CTCAE|3 years||||percentage of participants|||Number
2797384|NCT00540722|Primary|Overall Survival|The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.|4.5 years||||months||95% Confidence Interval|Median
2797385|NCT00540644|Secondary|Quality of Life Using the FACT-G Data|"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.~Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome"|baseline and after last cycle (up to 6 cycles)|All patients enrolled and received treatment with a baseline and post-baseline measurement.|||scores on a scale||Standard Deviation|Mean
2797386|NCT00540644|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Beginning of treatment up to 5 years|All patients enrolled and received treatment.|||participants|||Number
2797387|NCT00540644|Primary|Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria|Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.|After 6 cycles|All patients receiving at least one dose of study drug and having at least one post-baseline visit|||percentage of participants||95% Confidence Interval|Number
2797388|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2797420|NCT00540514|Secondary|Duration of Response in Responding Patients|Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment.|Assessed every 6 weeks, up to 38 months|Intent-to-treat patients with an objective response.|||months||95% Confidence Interval|Median
2797389|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2797390|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2797391|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2797392|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2797393|NCT00540592|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.|||Days||Full Range|Median
2797394|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
2797395|NCT00540592|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.|||Days||Full Range|Median
2797396|NCT00540592|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
2797397|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
2797398|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
2797656|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at Pre-dose 1|Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1|Pre-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
2797399|NCT00540592|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 180.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
2797400|NCT00540592|Secondary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
2797401|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||Subjects|||Number
2797402|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Subjects|||Number
2797403|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 180|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||fold increase||95% Confidence Interval|Geometric Mean
2797404|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 21|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
2797405|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||Subjects|||Number
2797406|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Subjects|||Number
2797407|NCT00540592|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.|||titer||95% Confidence Interval|Geometric Mean
2797408|NCT00540592|Secondary|HI Antibody Titers at Day 0 and Day 21|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
2797409|NCT00540592|Primary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
2797410|NCT00540579|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0|The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|24 Months|All patients treated with pomalidomide and gemcitabine were assessed for Grade 3/4 toxicities|||percentage of patients||95% Confidence Interval|Number
2798262|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in CGI-S Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2797411|NCT00540579|Primary|Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects|"Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows:~Inability to Complete cycle 1 of therapy due to drug-related toxicity.~> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care~Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C))~Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT)~Platelet count < 25,000/μL~Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity."|6 months|Two patients withdrew consent and were unevaluable for DLT. One patient suffered subdural hematoma (non-treatment related) and was unevaluable for DLT.|||milligrams|||Number
2797412|NCT00540514|Other Pre-specified|Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy|"Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.~Improvement in peripheral neuropathy was evaluated as:~Time to improvement of grade 3 or higher peripheral neuropathy by at least one grade;~Time to improvement of grade 3 or higher peripheral neuropathy to grade 1.~Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events."|38 months|Treated population with ≥ grade 3 treatment-related peripheral neuropathy.|||days||95% Confidence Interval|Median
2797413|NCT00540514|Other Pre-specified|Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count|The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.|||× 10^9/L||Standard Deviation|Mean
2797414|NCT00540514|Other Pre-specified|Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count|The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.|||× 10^9/L||Standard Deviation|Mean
2797415|NCT00540514|Other Pre-specified|Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin|The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.|||g/L||Standard Deviation|Mean
2797416|NCT00540514|Other Pre-specified|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.~A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.~Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesions).~Histology was determined at the time of primary diagnosis."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population. N indicates the number of participants in each histology category for each treatment arm respectively.|||percentage of participants|||Number
2797417|NCT00540514|Secondary|SPARC Status and Correlation With Overall Survival|"The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels.~To classify participants into high-SPARC and low-SPARC groups, an average z-score was calculated across variables and classified high-SPARC (average z-scores ≥0) and low-SPARC (average z-scores <0) groups.~SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause)."|Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.|SPARC biomarker Population|||participants|||Number
2797418|NCT00540514|Secondary|Pharmacokinetic (PK) Parameters||Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.|Patients randomized to receive albumin-bound paclitaxel/carboplatin treatment in Canada, Russia, Ukraine and United States had the option to participate in sparse PK sampling in this study. Only 15 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed.||||||
2797419|NCT00540514|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Up to 38 months|Treated population|||participants|||Number
2797421|NCT00540514|Secondary|Percentage of Participants With Controlled Disease|Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease.|Assessed every 6 weeks, up to 22 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2797422|NCT00540514|Secondary|Overall Participant Survival|Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive.|Up to 38 months|Intent-to-treat|||months||95% Confidence Interval|Median
2797423|NCT00540514|Secondary|Progression-free Survival by Blinded Radiology Assessment|"Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesion(s).~Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free."|Assessed every 6 weeks until progression or death, up to 38 months|Intent-to-treat|||months||95% Confidence Interval|Median
2797424|NCT00540514|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.~A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.~Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesions)."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population which includes all randomized patients regardless of whether the patient received any study drug or had any efficacy assessments collected.|||percentage of participants||95% Confidence Interval|Number
2797425|NCT00540449|Secondary|Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The ITT analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome measure."|||Participants|||Number
2797426|NCT00540449|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The ITT analysis set was considered the primary efficacy analysis set.|||cells per microliter||Standard Deviation|Mean
2797427|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797428|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48||Week 48|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797429|NCT00540449|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per ml at the last on-treatment visit (post-Week 96).|Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit|Participants with at least 1 Post-Week 96 visit were included in the analysis.|||Participants|||Number
2797430|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797431|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2800041|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
2797432|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/ml (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/ml in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/ml and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797433|NCT00540449|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
2797434|NCT00540436|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24|Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||Nanograms/Liter (ng/L)||Standard Deviation|Mean
2797435|NCT00540436|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24|PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||mmHg/L/min||Standard Deviation|Mean
2797436|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24|CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||L/min||Standard Deviation|Mean
2797437|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24|CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||L/min/m2||Standard Deviation|Mean
2797438|NCT00540436|Secondary|Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.|||mmHg||Standard Deviation|Mean
2797439|NCT00540436|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks.|Week 24|Full Analysis Set: : all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product|||Participants|||Number
2797440|NCT00540436|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward.|Weeks 12 and 24|Full Analysis Set|||Participants|||Number
2797441|NCT00540436|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward.|Baseline and Weeks 12 and 24|Full Analysis Set|||Points on a scale||Standard Deviation|Mean
2797442|NCT00540436|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal|Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward.|Baseline and Week 24/Withdrawal|Full Analysis Set|||Meters||Standard Deviation|Median
2797473|NCT00540293|Secondary|Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||percentage of participants||95% Confidence Interval|Mean
2797443|NCT00540436|Primary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12|Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.|Baseline and Week 12|Full Analysis Set (FAS): all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product. Imputation technique was last observation carried forward.|||Meters||Standard Deviation|Mean
2797444|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Vz/F|VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||Liters||Standard Deviation|Mean
2797445|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, CL/F|CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||L/hr (Liters/hour)||Standard Deviation|Mean
2797446|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24|"AUC is area under a concentration vs. time curve.~AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation:~AUC0-24= AUClast + Clast × (1 - e-λz × [24-tlast])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation."|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||hr*ng/mL||Standard Deviation|Mean
2797447|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Lambda z|Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||1/hour||Standard Deviation|Mean
2797448|NCT00540423|Secondary|Pharmacokinetics of SB-497115, t1/2|t1/2 is half life based on the terminal phase|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.|||Hours||Standard Deviation|Mean
2797449|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Tmax|tmax: Time when Cmax was achieved|Week 9 or 10|PK Population|||Hours||Full Range|Median
2797450|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Cmax|Cmax: Peak plasma concentration of SB-497115|Week 9 or 10|Pharmacokinetic (PK) Population: all participants with valid PK data following SB-497115-GR treatment|||ng/mL (nanograms/milliliter)||Standard Deviation|Mean
2797451|NCT00540423|Secondary|Mean Number of Days of Concomitant ITP Medication Use Per Month|Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Days||Standard Deviation|Mean
2797452|NCT00540423|Secondary|Percentage of Participants Who Received Rescue Treatment for ITP|Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Percentage of participants|||Number
2797453|NCT00540423|Secondary|Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline|ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline through Week 26|Full Analysis Set. Four participants in the Full Analysis Set did not have concomitant ITP medication at Baseline.|||Percentage of participants|||Number
2797454|NCT00540423|Secondary|Percentage of Participants With Bleeding Episode Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||Percentage of participants|||Number
2797455|NCT00540423|Secondary|Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Days||Standard Deviation|Mean
2797456|NCT00540423|Secondary|Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set|||Days||Standard Deviation|Mean
2797457|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
2797458|NCT00540423|Secondary|Mean Platelet Counts of Participants at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
2797459|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set|||Percentage of responders|||Number
2797460|NCT00540423|Secondary|Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||Participants|||Number
2797461|NCT00540423|Secondary|Percentage of Participants With Bleeding Episodes Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s).|Days 1, 8, 15, 22, 29, 36, and 43|Full Analysis Set|||Percentage of participants|||Number
2797462|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
2797463|NCT00540423|Secondary|Mean Platelet Count at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||10^9/Liter||Standard Deviation|Mean
2797464|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Days 8, 15, 22, 29, 36, and 43|Full Analysis Set|||Percentage of responders|||Number
2797465|NCT00540423|Primary|Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Week 26|Full Analysis Set|||percentage of participants|||Number
2797466|NCT00540423|Secondary|Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits.|Weeks 2 through 6|Full Analysis Set|||Participants|||Number
2797467|NCT00540423|Primary|Number of Responders at Week 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Week 6|Full Analysis Set: all randomized participants, with the exception of (1) those who did not receive any dose of study medication and (2) those with no valid platelet count measurements on therapy|||Participants|||Number
2797468|NCT00540293|Secondary|Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).|||percent||95% Confidence Interval|Median
2797469|NCT00540293|Secondary|Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|Baseline, and 8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).|||pg/dL||95% Confidence Interval|Median
2797470|NCT00540293|Secondary|Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Percent change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||percentage||95% Confidence Interval|Median
2797471|NCT00540293|Primary|Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.|LDL-C Responders by visit and by risk group - full analysis set (FAS)|Week 8|N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)|||Percentage of participants||95% Confidence Interval|Mean
2797472|NCT00540293|Secondary|Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Median baseline, and change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||mg/dL||95% Confidence Interval|Median
2797474|NCT00540293|Secondary|Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||Participants|||Number
2797475|NCT00540293|Secondary|Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|weeks 4 and 8|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).|||Percent||95% Confidence Interval|Mean
2797476|NCT00540293|Secondary|Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|Weeks 4 and 8||||mg/dL (ratio for Scalar)||95% Confidence Interval|Mean
2797477|NCT00540293|Secondary|Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.|LDL-C Responders by visit and by risk group - FAS|Week 4||||Percent subjects achieved LDL-C target||95% Confidence Interval|Mean
2797478|NCT00540228|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2797479|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2797480|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2797481|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2797482|NCT00540228|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2797483|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||cells||Standard Deviation|Mean
2797484|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||cells||Standard Deviation|Mean
2797485|NCT00540228|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2797511|NCT00540007|Secondary|Cytostatic Overall Response Rate|"Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months~Definitions per 2007 Cheson Lymphoma Response Criteria"|From 6 months through 3.5 years after study entry||||Participants|||Count of Participants
2798281|NCT00534495|Primary|Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids||At Week 12||||weeks||Inter-Quartile Range|Median
2797486|NCT00540228|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
2797487|NCT00540228|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
2797488|NCT00540228|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
2797489|NCT00540228|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2797490|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)|Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||milliliters||Standard Deviation|Mean
2797491|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)|Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||milliliters per second||Standard Deviation|Mean
2797492|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary|A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||average number per week||Standard Deviation|Mean
2797493|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary|A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||average number per week||Standard Deviation|Mean
2797494|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary|Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||average number per week||Standard Deviation|Mean
2797495|NCT00540124|Secondary|Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies|"Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||participants|||Number
2797496|NCT00540124|Secondary|Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||participants|||Number
2797497|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)|The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2797498|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore|IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2797499|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore|The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2797500|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore|The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2797501|NCT00540124|Secondary|Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 4 and 8 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2797502|NCT00540124|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2797503|NCT00540046|Secondary|Expulsion|IUD was not removed by provider but fell out on its own.|6 months|The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.|||percentage of expulsions|||Number
2797504|NCT00540046|Primary|Use of IUD|Number of participants using Copper T380A IUD 6 months after surgery|6 months||||participants|||Number
2797505|NCT00540007|Secondary|Duration of Response|-Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started|Through 3.5 years from study entry or until disease progression|(2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.|||months||Inter-Quartile Range|Median
2797506|NCT00540007|Secondary|Event Free Survival (EFS).|-Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).|Through 3.5 years from study entry or until disease progression|2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.|||months||95% Confidence Interval|Median
2797507|NCT00540007|Secondary|Relapse Free Survival (RFS)||Through 3.5 years from study entry or until disease progression|2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.|||months||95% Confidence Interval|Median
2797508|NCT00540007|Secondary|Overall Survival (OS)|Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.|Through 3.5 years from study entry or until disease progression|1 participant was not evaluable in Cohort 1 and 5 participants were not evaluable in Cohort 2 because these participants did not have death dates or last follow-up dates so overall survival cannot be calculated.|||months||95% Confidence Interval|Median
2797509|NCT00540007|Secondary|Time to Progression (TTP).|-Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.|Through 3.5 years from study entry or until disease progression|(2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.|||months||Inter-Quartile Range|Median
2797510|NCT00540007|Secondary|Participant Response Rate in Relapsed or Refractory cHL.|-Definitions per 2007 Cheson Lymphoma Response Criteria|Through 3.5 years from study entry or until disease progression||||Participants|||Count of Participants
2797512|NCT00540007|Secondary|Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.|"Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0~The higher the grade the worse the adverse event was considered"|30 days following the completion of treatment||||participants|||Number
2797513|NCT00540007|Primary|Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL.|"Overall response rate = CR + PR~Definitions per 2007 Cheson Lymphoma Response Criteria"|Through 3.5 years from study entry or until disease progression||||percentage of participants||95% Confidence Interval|Number
2797514|NCT00539994|Other Pre-specified|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|All subjects were positive (pos.) for S. Aureus in the Pharyngeal region on days 12 or 33 (D12 and D33) and Negative (neg.) in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33.|Per Protocol Population: Persistant Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and those who were Positive for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.|||Percentage of participants|||Number
2797515|NCT00539994|Secondary|Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)|The number of participants who tested negative for MRSA on days 7, 12, and 33.|Days 7, 12, or 33.|Screening Eligibility Population: only participants who provided nasal cultures at Days 7, 12, and 33 were analyzed.|||participants|||Number
2797516|NCT00539994|Secondary|Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.|All participants were assessed for nasal and pharyngeal carriage at Screening Visits 1, 2, and 3. Participants were randomized into the study only if they had positive cultures at screening visit 1 and screening visit 2 and/or screening visit 3. Day 1 data were collected only for those participants who were randomized into the study.|Screening Visits 1 (Day -42 to Day -14), 2 (Day -11 to Day -4), and 3 (Day -11 to Day -4) and Day 1|Screening Population (participants who had anterior nares swab obtained for S. aureus culture) was analyzed for Screening Visit (SV) 1. Only subjects who had positive cultures for S. aureus at SV 1 were allowed to continue to SV 2 and 3. The Safety Population (participants who received at least one dose of study drug) was analyzed at Day 1.|||participants|||Number
2797517|NCT00539994|Secondary|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|Percentage of subjects that were recolonized on Day 12 (D12) and Day 33 (D33) that were negative (neg.) for S. Aureus in the Pharyngeal region on days 12 or 33 and Negative in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3 and those who were NEGATIVE for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.|||Percentage of participants|||Number
2797518|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status|Comparison of nasal S. aureus eradication in persistent carrier subjects on 7, 12, and 33 days after treatment stratified by S. aureus carriage in the pharyngeal area|Days 1, 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and who were Persistent Nasal carriers who were both positive and negative carriers of S. aureus in the Pharyngeal region.|||Percentage of participants|||Number
2797519|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on Days 7 and 33 are negative and have eradicated of S. aureus.|Days 7 and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visits 1, 2 and 3.|||Percentage of participants|||Number
2797520|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Day 5|Per Protocol Population of Intent-to-treat|||hours||Standard Deviation|Mean
2797521|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Days 1 and 3|Per Protocol Population of Intent-to-treat|||hours||Standard Deviation|Mean
2797522|NCT00539994|Primary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.|Day 12|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2 and 3.|||Percentage of participants|||Number
2797523|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling|||ng/mL||Standard Deviation|Mean
2797524|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.|Days 1 and 3|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling|||ng/mL||Standard Deviation|Mean
2797525|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling|||ng.h/mL||Standard Deviation|Mean
2797657|NCT00538785|Secondary|Number of Subjects Who Had Anti-motavizumab Antibodies Detected|ECLA-based method|Days 0-150|Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.|||participants|||Number
2797526|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Days 1 and 3|Pharmacokinetic (PK) Concentration Population - included all subjects who underwent plasma PK sampling|||ng.h /mL||Standard Deviation|Mean
2797527|NCT00539942|Secondary|Incidence of Untoward Effects With Arixtra|Adverse events will be evaluated to determine untoward effects.|21 days|Unable to analyze data.|||participants|||Number
2797528|NCT00539942|Primary|Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra|Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.|21 days|Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.|||participants|||Number
2797529|NCT00539864|Secondary|Percentage of Participants With Seroprotection|Percentage of participants with (HAI titer greater than or equal to 40) at Day 28|Day 28 following immunization at Day 0||||Percentage of participants||95% Confidence Interval|Number
2797530|NCT00539864|Secondary|Percentage of Participants With Seroconversion|Percentage of participants with greater than or equal to a 4-fold rise in Hemagglutination-Inhibition Assay (HAI) titer over Day 0 at Day 28 following immunization|Day 28 following immunization at Day 0|All randomized subjects who received study vaccine and who had day 0 and day 28 HAI titers|||Percentage of participants|Participants|95% Confidence Interval|Number
2797531|NCT00539864|Primary|Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)|Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.|Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization|Safety population included all randomized subjects who received a dose of study vaccine.|||participants|||Number
2797532|NCT00539864|Secondary|Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.|Immunogenicity was assessed by measuring the difference in values in Hemagglutination-Inhibition Assay (HAI) titers in participants from Day 0 to Day 28, using Geometric Mean Titers (GMTs). The GMTs from the FluBlok and TIV groups were then compared.|Day 0 and Day 28|All randomized subjects who received study vaccine and had Day 0 and Day 28 HAI titers|||HAI Titers||95% Confidence Interval|Geometric Mean
2797533|NCT00539734|Primary|Time to Response (Implicit Time) of Multifocal ERG Signal|Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.|baseline, 3 months||||millisecond|Participants|Standard Deviation|Mean
2797534|NCT00539734|Secondary|Postoperative Complication|For instance, Endophthalmitis, retinal detachment|1 month|||||||
2797535|NCT00539734|Primary|Height (Amplitude) of Multifocal ERG Signal|Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.|baseline, 3 months|Analysis was per protocol|||nanovolt/degree^2|Participants|Standard Deviation|Mean
2797536|NCT00539695|Other Pre-specified|Ancillary Studies|"To conduct ancillary studies on those patients to investigate before, during and after IL-2 administration to determine:~The immunophenotype of PBMCs~The suppressive activity of CD4+ CD25+ FoxP3+ Tregs~Cytokines secreted by PBMCs~NK cell analysis"|12 weeks|||||||
2797537|NCT00539695|Secondary|Percentage Change in CD4+ CD25+ FoxP3+ Regulatory T Cells (Tregs) From Pre to Post IL-2 Infusions|To investigate the immunomodulatory effects of IL-2 administered after allogeneic hematopoietic stem cell transplantation|12 weeks|Participants received low-dose IL-2 and had pre and post IL-2 Treg measurements.|||percentage||Inter-Quartile Range|Median
2797538|NCT00539695|Secondary|Rate of Severe (Grade III or IV) Acute GVHD|To determine the efficacy of low-dose IL-2 in the prevention of severe (grade III or IV) acute GVHD|Up to 12 weeks on low-dose IL-2|Participants received low-dose IL-2|||percentage of participants||95% Confidence Interval|Number
2797539|NCT00539695|Primary|Rate of Dose Limiting Toxicities|Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients The outcome measure is the proportion of participants with dose limiting toxicities.|6-12 weeks||||proportion of participants of DLT||95% Confidence Interval|Number
2797540|NCT00539656|Secondary|Non-relapse Mortality|Number of participants who died without relapse in less than 100 days.|100 days||||Participants|||Count of Participants
2797541|NCT00539656|Primary|Neutrophil Engraftment Within 21 Days|Number of participants who reached 3 consecutive days with ANC > 500|21 days||||Participants|||Count of Participants
2797542|NCT00539656|Primary|Number of Participants With Toxicities Related to Infusion of Expanded Cord Blood Products||7 days||||Participants|||Count of Participants
2797543|NCT00539617|Secondary|Time to Progression (TTP)|Patient with objective tumor response or stable disease will be treated with single agent Tarceva until tumor progression. For this study, time to progression will be determined as the number of days following the first day of single agent treatment with Tarceva following the last and completed cycle of Tarcerva/FOLFOX combination therapy. TTP will be calculated for the entire patient population as well as for patients that objectively responded to the combination therapy versus those that did not.|Up to 2 years|No data was collected for time to progression||||||
2797544|NCT00539617|Secondary|Objective Response Rate (RR)|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). Best response assignment will depend on the achievement of both measurement and confirmation criteria using RECIST for both target and non-target lesions. For target lesions, response is defined as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in sum of the LD, taking as reference the baseline sum LD; PD: >=20% increase in sum of the LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions , Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 2 years|No data was collected for overall response rate||||||
2797675|NCT00538642|Secondary|LDL Cholesterol||4-5 months||||mg/dL||Standard Deviation|Mean
2797676|NCT00538642|Secondary|LDL Cholesterol||Baseline||||mg/dL||Standard Deviation|Mean
2797677|NCT00538642|Secondary|HDL Cholesterol||4-5 months||||mg/dL||Standard Deviation|Mean
2797545|NCT00539617|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from enrollment into the run-in period of the study to objective tumor progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The proportion of patients with PFS will be reported and evaluated using Kaplan-Meier survival curves with median survival and 95% confidence interval.|Up to 2 years|No data was collected for progression free survival||||||
2797546|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum B)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.||||||
2797547|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum A)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.|||T score||Standard Deviation|Mean
2797548|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum B)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.||||||
2797549|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum A)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.|||T score||Standard Deviation|Mean
2797550|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.|||units on a scale|||Number
2797551|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
2797552|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.|||units on a scale|||Number
2797553|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
2797554|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.|||units on a scale|||Number
2797555|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
2797556|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.|||units on a scale|||Number
2797581|NCT00539526|Primary|Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3|Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.|Baseline, Month 3||||Scores on Scale||Standard Error|Mean
2797557|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.|||units on a scale||Standard Deviation|Mean
2797558|NCT00539591|Other Pre-specified|Systemic Clearance (CL) of Interferon ɑ-2B|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||l/hr/m^2||Full Range|Median
2797559|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||l/m^2||Full Range|Median
2797560|NCT00539591|Other Pre-specified|Half-Life of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||hours||Full Range|Median
2797561|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic(PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.|||pcg * hr/ml||Full Range|Median
2797562|NCT00539591|Other Pre-specified|Apparent Clearance (CL) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis due to differences in clinical variables, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||ml/hr/kg||Full Range|Median
2797563|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling due to differences in clinical variables. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||ml/kg||Full Range|Median
2797564|NCT00539591|Other Pre-specified|ɑ Half Life of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||hours||Full Range|Median
2797565|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.|||pcg * hr/ml||Full Range|Median
2797580|NCT00539526|Secondary|Change From Baseline in Corneal Staining With Fluorescein at Month 3|Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.|Baseline, Month 3||||Scores on a Scale||Standard Error|Mean
2797566|NCT00539591|Other Pre-specified|Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B|"The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one patient had evaluable data in Stratum B and is not included in the final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling.|||pcg/ml||Full Range|Median
2797567|NCT00539591|Primary|Probability of Event-free Survival (EFS) of Stratum A Participants|The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method.|3 years from diagnosis||||probability||95% Confidence Interval|Number
2797568|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients|"The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants.~Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:~Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy~Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)~Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy~Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy~Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|Number of participants for the analysis was based on the intent to treat population, all patients enrolled were included. Participants were enrolled on Stratum A until the accrual goals were met on Stratum B.|||participants|||Number
2797569|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2|"The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants.~Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:~Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy~Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)~Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy~Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy~Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|This toxicity report was based on intention to treat population (ITT), all patients enrolled were included. The study did not meet its accrual goals within the planned timeframe due to slow accrual.|||participants|||Number
2797570|NCT00539591|Primary|Tumor Response Rate|Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment.|8 weeks||||participants|||Number
2797571|NCT00539539|Secondary|Ventilation Rate|Average ventilation rate (breaths/minute) during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm.|||breaths per minute||Standard Error|Mean
2797572|NCT00539539|Secondary|Percentage of Compressions With an Incomplete Release|Percentage of compressions with incomplete release during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm.|||% of compressions w/ incomplete release||Standard Error|Mean
2797573|NCT00539539|Secondary|Compression Rate|Average compression rate during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm.|||Compressions per minute||Standard Error|Mean
2797574|NCT00539539|Secondary|Compression Depth|Average compression depth (mm) during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm.|||mm||Standard Error|Mean
2797575|NCT00539539|Secondary|CPR Fraction|Percentage of time during CPR spend doing compressions.|Up to 10 minutes of CPR|Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm.|||Percentage||Standard Error|Mean
2797576|NCT00539539|Secondary|Survival to Hospital Discharge|Survival to hospital discharge|Length of Hospitalization|Intention to treat, with survival to hospital discharge missing for one participant on the feedback off arm. Analysis included 815 participants on the feedback on arm, and 770 on the feedback off arm.|||Participants|||Number
2797577|NCT00539539|Secondary|Pulses Present at ED Arrival.||Resuscitation|Intention to treat. Presence of pulses not known for one participant on the feedback off arm. Analysis includes 815 participants on the feedback on arm and 770 on the feedback off arm.|||Participants|||Number
2797578|NCT00539539|Primary|Rate of ROSC During the Prehospital Resuscitation|Return of spontaneous circulation (ROSC)|Prehospital resuscitation|Intent to treat|||Participants|||Number
2797579|NCT00539526|Secondary|Change From Baseline in Tear Break-Up Time (TBUT) at Month 3|Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Month 3||||Seconds||Standard Error|Mean
2797582|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at 12 Weeks|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression"|12 weeks|Participants that completed the study were analyzed|||units on a scale||Standard Deviation|Mean
2797583|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|12 Weeks|Participants who completed the intervention were included in the analysis|||units on a scale||Standard Deviation|Mean
2797584|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at Baseline|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression"|Baseline|Participants that completed the study were analyzed|||units on a scale||Standard Deviation|Mean
2797585|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|Baseline|Participants who completed the intervention were included in the analysis|||units on a scale||Standard Deviation|Mean
2797586|NCT00539500|Other Pre-specified|Number of Treated Participants With Engraftment Failure at Day 42|Engraftment failure is defined as if by day +42 participant does not have an absolute neutrophil count (ANC) >500/ul, and has no evidence of donor chimerism on bone marrow examination.|Participant evaluation at Day 42|Three subjects engrafted after receiving the investigational product, no other analysis available. Of the 3 participants enrolled, 0 had engraftment failure.|||participants|||Number
2797587|NCT00539500|Secondary|Number of Participants With Device-related Toxicity Associated With Transplantation of CD133+ Cells|Toxicity associated with CliniMACS device associated with transplantation of CD133+ cells in high-risk neuroblastoma. Adverse events assessed and graded according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|3 Years||||Participants|||Count of Participants
2797588|NCT00539500|Primary|Engraftment Failure Rate|Engraftment Failure Rate is number of participants with engraftment failure out of total participants. Engraftment failure is defined as failure to achieve an absolute neutrophil count (ANC) >500/ul by day 42, and has no evidence of donor chimerism on bone marrow examination.|Participant evaluation at Day 42, total study up to 3 Years|Study analysis not possible due to small number of participants. Of the 3 participants enrolled, 0 had engraftment failure.|||Participant|||Number
2797589|NCT00539305|Primary|Short-Form Health Survey (SF-36)|Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.|Baseline, Month 3, Month 6||||units on a scale||Standard Deviation|Mean
2797590|NCT00539305|Primary|Geriatric Depression Scale (GDS)|Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.|Baseline, Month 3, Month 6||||units on a scale||Standard Deviation|Mean
2797591|NCT00539305|Primary|Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test|Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.|Baseline, 3 and 6 months||||units on a scale||Standard Deviation|Mean
2797592|NCT00539305|Primary|Behavioral & Mood Measure: Profile of Mood States (POMS)|Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.|Baseline, 3 and 6 months|Vigor-Activity|||units on a scale||Standard Deviation|Mean
2797678|NCT00538642|Secondary|HDL Cholesterol||Baseline||||mg/dL||Standard Deviation|Mean
2797593|NCT00539279|Primary|Clinician-Administered PTSD Scale Severity Score (CAPS)|The CAPS is a clinician-administered interview about PTSD symptoms. There are 17 scored items for PTSD severity, each with response categories from 0 (zero) to 4 separately for both frequency and severity. Thus, each item can receive a score of 0 (zero) to 8, and the total severity score ranges from 0 to 136. Higher scores reflect higher levels of PTSD symptoms. Scores of 60 or above are generally considered clinically significant, and changes of 10 points or more (e.g., between pre-treatment and post-treatment) are considered clinically significant changes.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
2797594|NCT00539279|Secondary|Global Neuropsychological Deficits (Standardized, Composite)|Among our battery of seven neuropsychological tests, we worked with our neuropsychologist to choose 13 key scales. We used a conversion system to equally weight areas where there were large deficits, even if there were only one or two deficits, to prevent such scores from being minimized among the large range of T scores for the other scales. We converted T scores as follows: >40 = 0; 35-39 = 1; 30-34 = 2; 25-29 = 3; 20-24 = 4; < 20 = 5. Higher scores mean a higher global cognitive deficit.|Pre-treatment, post-treatment||||standardized units on a scale||Standard Deviation|Mean
2797595|NCT00539279|Secondary|Sheehan Disability Scale (SDS)|The SDS is a self-report questionnaire about functioning. There are 3 scored items (Work/School; Social Life; and Family Life/Home Responsibilities), each with response categories from 0 (zero; Not at All) to 10 (Extremely). Thus, the total score ranges from 0 to 30. Higher scores reflect lower (poorer) levels of functioning.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
2797596|NCT00539279|Primary|Patient Health Questionnaire Depression Subscale (PHQ-9)|"The PHQ-9 is a self-report questionnaire about depressive symptoms. There are 9 scored items, each with response categories from 0 (zero) to 3. Thus, the total score ranges from 0 to 27. Higher scores reflect higher levels of depressive symptoms, with interpretation as follows:~0 (zero) No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression"|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
2797597|NCT00539279|Secondary|State-Trait Anxiety Inventory State Scale (STAI-S)|"The STAI-S is a self-report questionnaire about state (present state) anxiety. There are 20 scored items, each with response categories from 1 (Not at All) to 4 (Very Much So). Some items (e.g., I feel calm) are reversed scored so that the total score appropriately reflects state anxiety. Thus, the total score ranges from 20 to 80. Higher scores reflect higher levels of state anxiety."|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
2797598|NCT00539279|Secondary|Posttraumatic Cognitions Inventory (PTCI)|The PTCI is a self-report questionnaire about thoughts following traumatic events. There are 33 scored items, each with response categories from 1 (Totally Disagree) to 7 (Totally Agree), summed to create the total score. Thus, the total score ranges from 7 to 231. Higher scores reflect higher levels of negative cognitions.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Mean
2797599|NCT00539279|Primary|PTSD Checklist (PCL)|The PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms.|Pre-treatment, post-treatment, and 6-month follow-up||||units on a scale||Standard Deviation|Median
2797600|NCT00539253|Primary|Nodule Enhancement|Percent area of nodule with enhancement|3 month|Number of participants analyzed reflects the number of participants for whom data was available|||percent enhancement||Standard Deviation|Mean
2797601|NCT00539253|Primary|Nodule Size|Maximal nodule size measured in centimeters|3 months|The number of participants analyzed reflects the number of participants for whom data was available.|||centimeters||Standard Deviation|Mean
2797602|NCT00539240|Primary|Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for acid regurgitation during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT|||days||Standard Deviation|Mean
2797603|NCT00539240|Primary|Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline|the number of days with Symptom Intensity Score < 3 (better) for nighttime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT|||days||Standard Deviation|Mean
2797604|NCT00539240|Secondary|Health Related Quality of Life|SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean.|end of study|ITT|||units on a scale||Standard Deviation|Mean
2797605|NCT00539240|Primary|Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for daytime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|intention to treat (ITT)|||days||Standard Deviation|Mean
2797606|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at Baseline|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|Baseline||||units on a scale|||Number
2797653|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3|30 days post-dose 3|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
2797607|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at Baseline|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|Baseline||||units on a scale|||Number
2797608|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at 6 Weeks|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|6 weeks||||units on a scale|||Number
2797609|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at 6 Weeks|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|6 weeks||||units on a scale|||Number
2797610|NCT00539110|Secondary|Pharmacokinetics|evaluate the PK of zolpidem following standard dosing practices|2 weeks postburn|||||||
2797611|NCT00539110|Primary|Polysomnography Data|Determine if intervention product elicits more total sleep time|2 weeks postburn||||minutes||Standard Error|Mean
2797612|NCT00539032|Primary|Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.||Day 28 Post-vaccination|4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.|||Percentage of Participants|||Number
2797613|NCT00539032|Primary|Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.||Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination|Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2797614|NCT00539032|Other Pre-specified|Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®|Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.|||Participants|||Number
2797615|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
2797616|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
2797617|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist|Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2797618|NCT00539006|Primary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Participants assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Participants|||Number
2797679|NCT00538642|Secondary|Cholesterol||4-5 months||||mg/dL||Standard Deviation|Mean
2797680|NCT00538642|Secondary|Cholesterol||Baseline||||mg/dL||Standard Deviation|Mean
2797619|NCT00539006|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
2797620|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use|"Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2797621|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat|"Participants assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2797622|NCT00538980|Secondary|Change in JAK2 Allele Burden|To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. Analysis was not completed because the study was terminated early due to lack of efficacy.|JAK2 analysis will be performed at baseline and month 3.|||||||
2797623|NCT00538980|Secondary|Change in Cytogenetics|To determine change in cytogenetics if initially abnormal. Analysis was not completed because the study was terminated early due to lack of efficacy.|Cytogenetics analysis will be performed at baseline and month 6.|||||||
2797624|NCT00538980|Secondary|Changes in Marrow Cellularity, Reticulin and Fibrous Content|To determine changes in marrow cellularity, reticulin and fibrous content. Analysis was not completed because the study was terminated early due to lack of efficacy.|Bone marrow analysis will be performed at baseline and month 6.|||||||
2797625|NCT00538980|Primary|Change in Performance Status and Development of Side Effects and Complications|To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.|Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.|||||||
2797626|NCT00538980|Primary|Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range|To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT <45% for men, <42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.|Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.|||||||
2797627|NCT00538915|Primary|Serious Bacterial Infections (SBIs) Compared to Historical Control Data.|Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.|One year|63 subjects enrolled, received treatment and included in the Safety population. 5 subjects excluded from the Intent To Treat (ITT) population due to significant, excessive protocol violations and an insufficient number of infusions to elicit the intended effect.|||SBIs Per Total Person-Years|||Number
2797628|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||score on a scale||Standard Deviation|Mean
2797629|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||score on a scale||Standard Deviation|Mean
2797681|NCT00538642|Secondary|Triglycerides||4-5 months||||mg/dL||Standard Deviation|Mean
2797682|NCT00538642|Secondary|Triglycerides||Baseline||||mg/dL||Standard Deviation|Mean
2797683|NCT00538642|Secondary|Diastolic Blood Pressure||4-5 months||||mm Hg||Standard Deviation|Mean
2797630|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Double-Blind portion of the study), Observed cases included.|||score on a scale||Standard Deviation|Mean
2797631|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||score on a scale||Standard Deviation|Mean
2797632|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).|||score on a scale||Standard Deviation|Mean
2797633|NCT00538902|Secondary|Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||mm||Standard Deviation|Mean
2797634|NCT00538902|Secondary|Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||mm||Standard Deviation|Mean
2797635|NCT00538902|Secondary|Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||mm||Standard Deviation|Mean
2797636|NCT00538902|Secondary|Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all subjects who received at least 1 dose of study drug during the double-blind period), Last Observation Carried Forward (LOCF).|||mm||Standard Deviation|Mean
2797654|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2|30 days post-dose 2|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
2797684|NCT00538642|Secondary|Diastolic Blood Pressure||Baseline||||mm Hg||Standard Deviation|Mean
2797637|NCT00538902|Secondary|Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Joints||Standard Deviation|Mean
2797638|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Joints||Standard Deviation|Mean
2797639|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).|||Joints||Standard Deviation|Mean
2797640|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Participants|||Number
2797641|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Participants|||Number
2797642|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.|||Participants|||Number
2797643|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.|Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), non-responder imputation (NRI; missing ACR responses imputed as non-responders).|||Participants|||Number
2797655|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1|30 days post-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
2797685|NCT00538642|Secondary|Systolic Blood Pressure||4-5 months||||mm Hg||Standard Deviation|Mean
2797644|NCT00538902|Primary|Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.|Week 12|Intent-to-treat population (ITT): all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study.|||Participants|||Number
2797645|NCT00538863|Primary|Percentage of Patients That Experienced 1 or More Adverse Events||Baseline to end of the study (up to 116 days)|Safety population: All patients who received study medication.|||Percentage of patients|||Number
2797646|NCT00538850|Secondary|Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing|Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.|30 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
2797647|NCT00538850|Secondary|Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing|Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5*PAR5), TOTPAR10=(5*PAR5)+(5*PAR10), TOTPAR15=(5*PAR5)+(5*PAR10)+(5*PAR15), TOTPAR30=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30), TOTPAR45=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30)+(15*PAR45), TOTPAR60=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30) +(15*PAR45) +(15*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.|5 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
2797648|NCT00538850|Secondary|Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing|"Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented no pain and 100 represented worst possible pain at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5*PID5), SPID10=(5*PID5)+(5*PID10), SPID15=(5*PID5)+(5*PID10)+(5*PID15), SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30), SPID45=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30)+(15*PID45), SPID60=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30) +(15*PID45) +(15*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain."|Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
2797649|NCT00538850|Primary|Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)|"Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented no pain and 100 represented worst possible pain at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain."|Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.|||Units on a scale||Standard Deviation|Mean
2797650|NCT00538824|Primary|Effect of Drug Combination on Multiple Myeloma|The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/|The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks||||participants|||Number
2797651|NCT00538785|Secondary|Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass|Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.|Days 0-150|Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.|||ug/mL||Standard Deviation|Mean
2797652|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4|30 days post-dose 4|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.|||ug/mL||Standard Deviation|Mean
2797658|NCT00538785|Secondary|The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.|An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.|Days 0-150|All subjects who were randomized in Season 2|||participant|||Number
2797659|NCT00538785|Secondary|The Number of Subjects Hospitalized for RSV Infection.|An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).|Days 0-150|The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.|||participants|||Number
2797660|NCT00538785|Primary|Number of Subjects Reporting Laboratory Adverse Events||Days 0-150|Safety population|||participants|||Number
2797661|NCT00538785|Primary|Number of Subjects Reporting Serious Adverse Events Through Study Day 150|Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.|||participants|||Number
2797662|NCT00538785|Primary|Number of Subjects Reporting Adverse Events Through Study Day 150|Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.|||participants|||Number
2797663|NCT00538759|Secondary|Aortic Valve Mean Gradient||6 months|Study was halted early due to funding shortfall. Did not reach enrollment goal|||mmHg||Standard Error|Mean
2797664|NCT00538759|Secondary|Aortic Valve Area Late Loss Index|The difference between the Aortic Valve Area at 6 months and the Aortic Valve Area post procedure indexed to the subject|6 months|Study was halted early due to funding shortfall. Did not reach enrollment goal|||cm^2||Standard Error|Mean
2797665|NCT00538759|Secondary|Aortic Valve Reintervention||6 months||||Participants|||Count of Participants
2797666|NCT00538759|Secondary|CHF Rehospitalization||6 months||||Participants|||Count of Participants
2797667|NCT00538759|Secondary|NYHA Improvement|"Improvement from pre-procedural NYHA class. Patients' heart failure were graded according to the severity of their symptoms. The New York Heart Association (NYHA) Functional Classification was used. It places patients in one of four categories based on how much they are limited during physical activity.~I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|6 months||||Participants|||Count of Participants
2797668|NCT00538759|Primary|Incidence of Major External Beam Radiation Therapy-related Complications||6 months||||Participants|||Count of Participants
2797669|NCT00538759|Primary|Aortic Valve Area as a Continuous Variable, Measured by Echocardiography||6 months|Study was halted early due to funding shortfall. Did not reach enrollment goal|||cm^2||Standard Error|Mean
2797670|NCT00538733|Secondary|Progression Free Survival|"Progression determined using International Myeloma Working Group criteria, as defined below.~An increase of > 25% from lowest response value one or more of the following:~Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*~Urine M-component and/or (the absolute increase must be > 200 mg/24 h)~Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL~Bone marrow plasma cell percentage; the absolute percentage must be > 10%~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder *if starting serum M protein is greater then 5 g/dL, absolute increase of 1g/dL is sufficient to determine relapse."|From start of treatment, to the date of first progression|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.|||months||95% Confidence Interval|Median
2797671|NCT00538733|Secondary|Event Free Survival||from baseline to the time of first event that lead to removal from study (defined as progression, death, withdrawal of consent, or removal for toxicity)||||months||95% Confidence Interval|Median
2797672|NCT00538733|Secondary|Median Time to Maximum Response|Median Time to maximum response, reported in cycles of treatment. One cycle = 28 days.|from baseline to cycle with maximum response|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.|||cycles||Full Range|Median
2797673|NCT00538733|Primary|Effect of Drug Combination on Multiple Myeloma|Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/|This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles|25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.|||participants|||Number
2797674|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|4-5 months||||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
2797692|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797693|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797694|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797695|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia and who had received at least 1 dose of study medication.|||Participants|||Number
2797696|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797697|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797698|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797699|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797700|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797701|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797702|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797703|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797704|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2798381|NCT00534235|Secondary|Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm|Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.|5 years||||Participants|||Count of Participants
2797705|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797706|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797707|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797708|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797709|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797710|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797711|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797712|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication|||Participants|||Number
2797713|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797714|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797715|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797716|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797717|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797754|NCT00538473|Primary|Duration of Solicited General Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
2797718|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication|||Participants|||Number
2797719|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.|||Participants|||Number
2797720|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.|||Participants|||Number
2797721|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.|||Participants|||Number
2797722|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797723|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797724|NCT00538629|Primary|Global Efficacy Evaluation Scores (Schizophrenia Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.|||Participants|||Number
2797725|NCT00538629|Primary|Global Efficacy Evaluation Scores (Bipolar Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797726|NCT00538629|Primary|Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit|EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
2797727|NCT00538629|Primary|Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline|BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
2797728|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects who had been diagnosed with schizophrenia and had received at least 1 dose of study medication.|||Participants|||Number
2797729|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797730|NCT00538629|Primary|Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline|MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
2800042|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
2797731|NCT00538629|Primary|Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline|The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If the final visit measurement was missing, the follow-up measurement could be carried forward. If any individual item was missing, the total score was set to missing.|||Score on scale||Standard Deviation|Mean
2797732|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication|||Participants|||Number
2797733|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.|||Participants|||Number
2797734|NCT00538616|Primary|Lactate/Pyruvate (L/P)Ratio|L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.|1 hour||||ratio||Standard Deviation|Mean
2797735|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|30 days||||mm Hg||Standard Deviation|Mean
2797736|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|90 days||||mm Hg||Standard Deviation|Mean
2797737|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|180 days||||mm Hg||Standard Deviation|Mean
2797738|NCT00538590|Secondary|Complications|Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.|360 days||||percentage of participants||Standard Deviation|Mean
2797739|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|360 days||||mm Hg||Standard Deviation|Mean
2797740|NCT00538512|Secondary|Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.|Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection).|Time between prevaccination and postvaccination, typically about 30 days.|Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.|||Participants|||Count of Participants
2797741|NCT00538512|Secondary|Immune Response to Vaccination and Infection|Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit.|Postvaccination to postseason visit; typically about 3 months.|Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.|||Participants|||Count of Participants
2797742|NCT00538512|Secondary|Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection|Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit.|Time between prevaccination visit and postvaccination visit; typically about 30 days.|Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.|||Participants|||Count of Participants
2797743|NCT00538512|Primary|Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza||one influenza season - 2007-2008|ITT|||participants|||Number
2797755|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2797744|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2797745|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2797746|NCT00538473|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2797747|NCT00538473|Secondary|Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||fold increase||95% Confidence Interval|Mean
2797748|NCT00538473|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2797749|NCT00538473|Secondary|Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2797750|NCT00538473|Secondary|Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2797751|NCT00538473|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.|Throughout the entire study (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2797752|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2797753|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2798382|NCT00534235|Secondary|Mean Visual Analog Scale (VAS) Leg (Left) Pain Score|Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.|5 years||||mm||Standard Deviation|Mean
2797756|NCT00538473|Primary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.|||Days||Full Range|Median
2797757|NCT00538473|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.|||Subjects|||Number
2797758|NCT00538434|Secondary|Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)|CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.|Baseline, End of Treatment (up to 15 weeks +/- 4 days)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.|||percentage change in score||Standard Deviation|Mean
2797759|NCT00538434|Secondary|Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment|Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week's daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.|||units on a scale||Standard Deviation|Mean
2797760|NCT00538434|Primary|Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)|"The investigator completed the Physician's EE Global Assessment based upon the participant's reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject's Predominant EE Symptom Assessment, the subject's diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.~The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status."|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.|||units on a scale||Standard Deviation|Mean
2797761|NCT00538434|Primary|Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels|Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.|Baseline, End of Treatment (up to 15 weeks [+/- 4 days])|ITT population: all randomized participants who received any amount of study drug.|||percentage change in eosinophils/hpf||Standard Deviation|Mean
2797762|NCT00538304|Secondary|Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1|"Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?. The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor's office told them to expect."|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Patients|||Number
2797763|NCT00538304|Secondary|Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1|"Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason."|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Patients|||Number
2798383|NCT00534235|Secondary|Mean Visual Analog Scale (VAS) Leg (Right) Pain Score|Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.|5 years||||mm||Standard Deviation|Mean
2797764|NCT00538304|Secondary|Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1|"Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked Overall, based on how well this drug lowered THIS patient's IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason."|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Physicians|||Number
2797765|NCT00538304|Secondary|Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1|Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2797766|NCT00538304|Secondary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1|Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Percentage of Patients|||Number
2797767|NCT00538304|Primary|Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1|Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.|||Number on a scale (score)||Standard Deviation|Mean
2797768|NCT00538291|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Assessment after every 2 cycles of treatment, up to 1 year.|The three patients not completing at least two courses of treatment were considered treatment failures and were included in efficacy analysis.|||number of responding participants|||Number
2797769|NCT00538213|Secondary|The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||CD8 cells/10^6 CD8+ cells||Standard Deviation|Geometric Mean
2797770|NCT00538213|Secondary|The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||CD4 cells/10^6 CD4+ cells||Standard Deviation|Geometric Mean
2797771|NCT00538213|Secondary|The Number of Subjects Seroprotected to HI Antibodies|Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||subjects|||Number
2797772|NCT00538213|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
2797773|NCT00538213|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||subjects|||Number
2797786|NCT00537979|Secondary|Proportion of Subjects Who Achieve an iPTH <300 pg/mL|Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.|||participants|||Number
2797774|NCT00538213|Secondary|The Number of Subjects Seropositive to HI Antibodies|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||subjects|||Number
2797775|NCT00538213|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
2797776|NCT00538213|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2797777|NCT00538213|Primary|Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2797778|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2797779|NCT00538213|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2797780|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2797781|NCT00538213|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2797782|NCT00538213|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2797783|NCT00537979|Secondary|Health-related Quality of Life With Paricalcitol Injection or Oral Treatment|Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.|Baseline and 24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.|||Participants|||Number
2797784|NCT00537979|Secondary|Duration of Response to Treatment|Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.|||days||Standard Deviation|Mean
2797785|NCT00537979|Secondary|Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level|Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.|||days||Standard Deviation|Mean
2798384|NCT00534235|Secondary|Mean Visual Analog Scale Leg (Worse) Pain Score|Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.|5 years||||mm||Standard Deviation|Mean
2797787|NCT00537979|Secondary|Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)|Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.|24 Weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.|||participants|||Number
2797788|NCT00537979|Primary|Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level|Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.|||participants|||Number
2797789|NCT00537940|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specifictime points for each arm group, respectively.|||percentage of participants|||Number
2797790|NCT00537940|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score.|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range:0-100; higher score=more intensity of attribute.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
2797791|NCT00537940|Secondary|Hospital Anxiety and Depression Scale (HADS) Score.|HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
2797792|NCT00537940|Secondary|Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.|SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n is the number of participants analyzed for SGTC. Twenty-six participants were not included in the n because they did not have a post Baseline all partial seizure, but they were included in the analysis by seizure type.|||percentage of responders||95% Confidence Interval|Number
2797793|NCT00537940|Secondary|Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.|Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of all partial seizure/28days||Standard Deviation|Mean
2797794|NCT00537940|Secondary|Percentage of Participants Without Seizures.|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2797795|NCT00537940|Secondary|Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of participants that can be analyzed for each treatment group.|||Percentage of participants||95% Confidence Interval|Number
2797840|NCT00537407|Secondary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||Log10(IU/mL)||Standard Deviation|Mean
2797796|NCT00537940|Secondary|Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of subjects that can be analyzed for each treatment group.|||Percentage of participants||95% Confidence Interval|Number
2797797|NCT00537940|Primary|Percent Change From Baseline in 28-day Seizure Frequency at Week 21.|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.|||percent change||Full Range|Median
2797798|NCT00537823|Secondary|Change in Tumor Size From Pretreatment to Preoperative CT Scan|-Compare total longest diameter from baseline to preoperative CT scan.|Completion of neoadjuvant therapy (approximately 8 weeks)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.|||percentage of change of longest diameter||Full Range|Median
2797799|NCT00537823|Secondary|Effect of Preoperative Chemotherapy on Tumor Size|Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.|Upon completion of neoadjuvant chemotherapy (approximately 2 months)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.|||participants|||Number
2797800|NCT00537823|Secondary|Liver Injury Scale Score (0-27)||Time of surgery (approximately 11-16 weeks)|Data was not collected for this outcome measure as the study pathologist left the institution early prior to study closure.||||||
2797801|NCT00537823|Secondary|Nonalcoholic Steatohepatitis Score (0-3)|"NASH Scoring~Steatosis **<5% = 0~**5-33%=1~**>33-66%=2~**>66%=3~Lobular inflammation~**No foci=0~**<2 foci per x 200 field=1~**2-4 foci per x 200 field=2~**>4 foci per x 200 field=3~Hepatocellular ballooning **None=0 **Few balloon cells = 1 **Many cells/prominent ballooning=2"|Time of surgery (approximately 11-16 weeks)|"4 participants did not have surgery and are not included in this outcome measure.~The study pathologist left the university early prior to completion of study pathology for this study."|||participants|||Number
2797802|NCT00537823|Secondary|Histologic Hepatic Toxicity at Surgery||Time of surgery (approximately 11-16 weeks)|4 participants did not have surgery.|||participants|||Number
2797803|NCT00537823|Secondary|Postoperative Recurrence Patterns|Liver only vs distant disease|Up to 5 years|7 participants were not evaluable. 4 participants did not have surgery (3 in Arm 1, 1 in Arm 2). 1 participant had surgery but was not resectable (Arm 1) . 1 participant developed another primary cancer (Arm 1). 1 participant died before recurrence from hepatic failure (Arm 1).|||participants|||Number
2797804|NCT00537823|Primary|All-cause Mortality||30 days following surgery|4 participants did not have surgery.|||participants|||Number
2797805|NCT00537823|Primary|Major Postoperative Complication Rate|Fraction of patients with any complication grades IV and V|30 days following surgery|4 participants did not have surgery.|||percentage of participants|||Number
2797806|NCT00537823|Primary|Postoperative Complication Rate|Fraction of patients with any grade of complication I-V|30 days following surgery|4 participants did not have surgery.|||percentage of participants|||Number
2797807|NCT00537810|Primary|BMI||4 months treatment|Participants with complete data reported here (i.e., no imputation)|||BMI (kg/m^2)||Standard Deviation|Mean
2797808|NCT00537810|Primary|Binge Eating (Remission)|Remission from binge eating (zero binge episodes during previous 28 days)|4 months treatment; 6 and 12 month follow up post treatment||||participants|||Number
2797809|NCT00537771|Secondary|Time to Treatment Failure||Within 3 years||||days||95% Confidence Interval|Median
2797810|NCT00537771|Secondary|Incidence of Abnormal Liver Function|The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.|At 48 weeks, 96 weeks, 144 weeks||||participants|||Number
2797811|NCT00537771|Primary|Incidence of Fatty Liver Disease|The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.|At 48 weeks, 96 weeks, 144 weeks||||participants|||Number
2797812|NCT00537745|Primary|% Days w/1+Interlock Test Failures|This describes the percent of days in past month where the subject at least 1 interlock test failure.|One month post treatment|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.|||percent of days||Full Range|Mean
2797813|NCT00537745|Primary|Evidence of Attempts to Drive After Drinking|"This was measured as Percent of days with an Interlock report of Failure to Start due to alcohol pre/on medication and 6 months post medication."|6 months|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.|||percent of days|Participants|Full Range|Mean
2797814|NCT00537680|Secondary|FACT|Friedreich's Ataxia Composite Test|6 Months|||||||
2797815|NCT00537680|Secondary|ADL of FARS|ADL=Activities of Daily Living|6 Months|||||||
2797816|NCT00537680|Secondary|FARS|Friedreich's Ataxia Rating Scale|6 Months|||||||
2798385|NCT00534235|Secondary|Mean Visual Analog Scale Back Pain Score|Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.|5 years||||mm||Standard Deviation|Mean
2797817|NCT00537680|Primary|ICARS|"International Cooperative Ataxia Rating Scale (ICARS):~ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.~Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 6 months||||ICARS points||Standard Deviation|Mean
2797818|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).|Safety population; participants continuing in the Recovery Period and Maintenance Phase.|||participants|||Number
2797819|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).|Safety population|||participants|||Number
2797820|NCT00537511|Secondary|Overall Survival|Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.|From enrollment through study termination (approximately 35 months)|Participants in the ITT population.|||weeks||95% Confidence Interval|Median
2797821|NCT00537511|Secondary|Duration of Response|Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.|From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)|Number of participants in ITT population who were considered Responders.|||weeks||Standard Deviation|Mean
2797822|NCT00537511|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)|Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Cycles 1 -6 (21-day cycles)|ITT population. 'Not Assessed' category includes participants who did not have adequate data for response assessment at baseline and/or post-baseline prior to the use of any non-protocol anti-tumor therapy.|||participants|||Number
2797823|NCT00537511|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase|For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.|Cycles 1 - 6 (21-day cycles)|Safety Population|||participants|||Number
2797824|NCT00537511|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)|Cycle 1 (21 days)|Safety Population|||mg|||Number
2797841|NCT00537407|Primary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||Log10(IU/mL)||Standard Deviation|Mean
2797825|NCT00537485|Secondary|The Modified Hoehn and Yahr Stage|Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.|Baseline, end of maintenance period|FAS, LOCF|||Percentage of participants|||Number
2797826|NCT00537485|Secondary|Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.~UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2797827|NCT00537485|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2797828|NCT00537485|Secondary|UPDRS Part 1 Sum Score|"MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2797829|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
2797830|NCT00537485|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2797831|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks||||Percentage of participants||95% Confidence Interval|Number
2797832|NCT00537485|Secondary|Mean Change in UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks||||Scores on a scale||Standard Deviation|Mean
2797833|NCT00537485|Secondary|Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period|baseline, end of maintenance period|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
2797834|NCT00537485|Primary|Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, end of maintenance period|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2797835|NCT00537407|Secondary|Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)|A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL).|24 weeks after the end of treatment (Week 72 or 96)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants|||Number
2797836|NCT00537407|Secondary|Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)|A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL).|End of treatment (Week 48 or 72)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants|||Number
2797837|NCT00537407|Secondary|Percentage of Participants With an Early Viral Response at Week 12|A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline.|Baseline to Week 12|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants|||Number
2797838|NCT00537407|Secondary|Percentage of Participants With a Rapid Viral Response at Day 29|A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL).|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||percentage of participants||95% Confidence Interval|Number
2797839|NCT00537407|Secondary|log10 Hepatitis C Virus RNA at Day 29|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.|||Log10(IU/mL)||Standard Deviation|Mean
2798386|NCT00534235|Secondary|Mean Oswestry Disability Index (ODI) Score|Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.|5 years||||units on a scale||Standard Deviation|Mean
2797842|NCT00537394|Secondary|Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure|Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir.|Between baseline and confirmed virologic failure (up to 96 weeks)|Those with confirmed virologic failure (N=54; N=50) among the randomized arms included; and those who were missing resistance information following virologic failure (N=2; N=4) are excluded.|||participants|||Number
2797843|NCT00537394|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline|Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded.|From study entry to Weeks 24, 48|All randomized participants who started study treatment. Non-fasting results and missing results excluded from analysis. Therefore, differences reported here represent a complete case analysis.|||mg/dL||Standard Deviation|Mean
2797844|NCT00537394|Secondary|Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry|HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure.|From study entry to time of confirmed virological failure (up to 96 weeks)|Only randomized participants with R5-tropic virus at study entry (N=89; N=88), and who experienced confirmed virologic failure (N=27; N=22) during follow-up, and who had a tropism test following failure are included.|||participants|||Number
2797845|NCT00537394|Secondary|Time From Treatment Dispensation to Serious Non-AIDS-defining Events|Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit.|From treatment initiation to week 96 study visit|Randomized participants were included, and those not starting study treatment were excluded.|||weeks||95% Confidence Interval|Number
2797846|NCT00537394|Secondary|Change in CD4 Count From Baseline|Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded.|From study entry to Weeks 48 and 96|All subjects in the two randomized arms were assessed.|||cells/mm^3||Inter-Quartile Range|Median
2797847|NCT00537394|Secondary|Change in Cardiovascular Risk Score From Baseline|Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score.|At Weeks 24, 48, and 96|Persons not starting treatment (N=1; N=2), who had cardiovascular disease prior to study entry (N=12; N=8), or were missing input values needed to calculate a baseline Framingham score (N= 6; N=4), were excluded.|||units on a scale||Standard Deviation|Mean
2797848|NCT00537394|Secondary|Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)|Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent.|At Weeks 24 and 48|Persons not starting study treatment, or not receiving assigned study treatment by randomization were excluded from all analyses. If person no longer in study follow-up before beginning of week 24 or 48 evaluation window, additionally excluded as applicable.|||participants|||Number
2797849|NCT00537394|Secondary|Change in Summarized Quality of Life Score|Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health).|At study entry and Weeks 24, 48, 96|Two randomized arms only.|||units on a scale||Inter-Quartile Range|Median
2797850|NCT00537394|Secondary|Change in Plasma HIV-1 Viral Load From Baseline to Week 1|Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL.|From baseline to Week 1 evaluation|Modified intent to treat population among two randomized arms only: 2 participants (both in Omit NRTIs arm) were excluded because their baseline and week 1 RNA levels were both < 50 copies/mL.|||log10 copies/mL||Inter-Quartile Range|Median
2797851|NCT00537394|Secondary|Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml|Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded.|At Weeks 24, 48, 96|ITT - among 2 randomized arms only; closest value to scheduled week used if multiple values available; missing values excluded. Numbers analyzed at each time point represent those with a valid RNA result.|||participants|||Number
2797852|NCT00537394|Secondary|Time From Randomization to Confirmed Virological Failure|Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested.|From randomization to week 96 study visit|ITT (all randomized participants) included.|||weeks||95% Confidence Interval|Number
2797904|NCT00537095|Secondary|Time to Death|Interim analysis time to date of randomisation to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.|time from randomisation to date of death|For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo|||participants|||Number
2797853|NCT00537394|Secondary|Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment|Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation.|From randomization to week 96 study visit|All randomized participants included (i.e. ITT analysis).|||weeks||95% Confidence Interval|Number
2797854|NCT00537394|Secondary|Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)|First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization.|From treatment dispensation to week 96 study visit|Only randomized participants included, and those who never started study treatment were excluded.|||weeks||95% Confidence Interval|Number
2797855|NCT00537394|Secondary|Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality|Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality).|From treatment dispensation to week 96 study visit|Only randomized participants included. Persons not starting study treatment excluded.|||weeks||95% Confidence Interval|Number
2797856|NCT00537394|Primary|Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment|Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method.|From study entry to end of Week 48 evaluation window|Analysis uses intent to treat population, among the two randomized arms only.|||percentage of participants||95% Confidence Interval|Number
2797857|NCT00537381|Secondary|Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Percent change||Standard Deviation|Mean
2797858|NCT00537381|Secondary|Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Percent change||Standard Deviation|Mean
2797859|NCT00537381|Secondary|Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Percent change||Standard Deviation|Mean
2797860|NCT00537381|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline until death (up to 887 days)|Efficacy population included all participants randomly assigned to study treatment.|||Days||95% Confidence Interval|Median
2797861|NCT00537381|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).|Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days|Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart.|||Participants|||Number
2797905|NCT00537095|Secondary|Objective Response Rate|Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria|46.7 months||||participants|||Number
2797862|NCT00537381|Secondary|Number of Participants With Best Overall Response (OR)|Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Response evaluable population included participants who had target lesion or non-target lesion at baseline and received at least 1 study treatment and had at least 1 post-baseline response assessment or discontinued study treatment due to disease progression, or death.|||Participants|||Number
2797863|NCT00537381|Primary|Progression-Free Survival (PFS)|The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Efficacy population included all participants randomly assigned to study treatment.|||Days||95% Confidence Interval|Median
2797864|NCT00537329|Secondary|Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups|Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.|EOT (Day 5 up to Day 42)|MITT. May have >1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation.|||participants|||Number
2797865|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT|Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."|||percent change||Standard Deviation|Mean
2797866|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."|||pg/mL||Standard Deviation|Mean
2797867|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."|||percent change||Standard Deviation|Mean
2797868|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."|||pg/mL||Standard Deviation|Mean
2797906|NCT00537095|Secondary|Disease Control Rate at 6 Months|number of participants that achieved disease control 6 months after randomisation. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria|6 months after randomisation||||participants|||Number
2797869|NCT00537329|Secondary|Time to Death Due to Candidemia|"Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population.|||days||Full Range|Median
2797870|NCT00537329|Secondary|Time to Death From Any Cause|"Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; < 50% of subjects died out of the analyzable population.|||days||Full Range|Median
2797871|NCT00537329|Secondary|Number of Subjects With Microbiological Response of Success at Endpoints|Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|||participants|||Number
2797872|NCT00537329|Secondary|Number of Subjects With Clinical Response of Success at Endpoints|Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|||participants|||Number
2797873|NCT00537329|Secondary|Number of Subjects With Global Response of Success at Endpoints|Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.|End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)|"MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|||participants|||Number
2797874|NCT00537329|Primary|Number of Subjects With Global Response of Success at End of Treatment|Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.|End of treatment (EOT) = Day 5 up to Day 42|Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment.|||participants|||Number
2797875|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study|Weeks 38, 62 and 94 (Weeks 22, 46 and 78 for direct entry)|||||||
2797876|NCT00537316|Secondary|Proportion of Participants Who Are in Steroid-free Remission During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study.|Weeks 38, 62 & 94 (Weeks 22, 46 and 78 for direct entry)|||||||
2797877|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing at Week 16|Mucosal healing was defined as a Mayo endoscopy score of 0 or 1.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation).|||Proportion of participants|||Number
2797878|NCT00537316|Secondary|Proportion of Participants in Response at Weeks 8 and 16|Response at Week 8 is defined as a decrease in the partial Mayo score of ≥1 point. Response at Week 16 is defined as a decrease in total Mayo score of ≥3 points and at least 30% lower than baseline Mayo score. The partial Mayo score consists of the following 3 sub-scores: stool frequency, rectal bleeding, and physician's global assessment. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician's global assessment.|Weeks 8 and 16|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-responders) at Week 16.|||Proportion of participants|||Number
2797879|NCT00537316|Primary|Average Remission Rate During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study (Week 38 through Week 94 [Week 22 through Week 78 for direct entry]).|up to Week 94 (Week 78 for direct entry)|||||||
2797907|NCT00537095|Primary|Time to Tumor Progression|modified RECIST V1.0 was used|Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment||||days||95% Confidence Interval|Median
2797880|NCT00537316|Primary|Proportion of Participants in Steroid-free Remission at Week 16|Steroid-free remission is defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point, without the use of corticosteroids. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician's global assessment.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-remission) at Week 16.|||Proportion of participants|||Number
2797881|NCT00537303|Secondary|Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide|High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||mg/L||Standard Deviation|Mean
2797882|NCT00537303|Secondary|Haematology: Haemoglobin Measured in Blood|Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||mmol/L||Standard Deviation|Mean
2797883|NCT00537303|Secondary|Biochemistry: Serum Alanine Aminotransferase|Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||U/L||Standard Deviation|Mean
2797884|NCT00537303|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.|||episodes|||Number
2797885|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol analysis set.|week 36|Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
2797886|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Analysed for the full analysis set.|week 36|Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
2797887|NCT00537290|Secondary|The Efficacy of Rituximab|Outcome measures scored as complete response(CR),partial(PR),and none(NR) at 24 weeks.For thrombocytopenia,CR defined as a platelet count of ≥150×109/μl,PR as 100-149,and NR as <100.For CVD,CR defined as the disappearance of cardiac lesions,PR as 50%improvement,and NR as no change.For skin ulcer,CR defined as disappearance,PR as 50% improvement,and NR as no change.For aPL nephropathy,CR defined as a normal serum creatinine level,inactive urinary sediment,and urinary protein:creatinine 0.5;PR as a serum cr level 15%above baseline,RBCs per high-power field 50%above baseline with no casts,50%improvement in the urinary prt:cr,and estimated GFR 10%above baseline;and NR as the absence of C/PR.For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%,and NR as no change.|24 weeks|All patients enrolled in the study|||Participants|||Count of Participants
2797888|NCT00537290|Primary|Number of Participants Experiencing Serious and Non Serious Adverse Events|Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.|52 weeks + additional 4 months if needed|All patients enrolled in the study.|||Participants|||Count of Participants
2797889|NCT00537277|Secondary|Number of Treatment Emergent Serious Adverse Events (SAEs)|Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||events|||Number
2797890|NCT00537277|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||episodes|||Number
2797891|NCT00537277|Secondary|Number of Diurnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||episodes|||Number
2797892|NCT00537277|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.|||episodes|||Number
2797893|NCT00537277|Secondary|Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.|||percentage of trial completers|||Number
2797894|NCT00537277|Primary|Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
2797895|NCT00537238|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2797896|NCT00537238|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study medication and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2797897|NCT00537238|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2797898|NCT00537238|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up|BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.|Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Least Squares Mean
2797899|NCT00537238|Secondary|Percentage of Participants Without Seizures|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|Baseline up to Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2797900|NCT00537238|Secondary|Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16|Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.|Baseline, Week 16|SGTC population included all participants who had at least 1 SGTC seizure during either baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage of all partial seizure/28days||Standard Deviation|Mean
2797901|NCT00537238|Secondary|Percent Change From Baseline in 28 Day Seizure Frequency at Week 16|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.|Baseline, Week 16|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.|||percent change||Full Range|Median
2797902|NCT00537238|Primary|Proportion of Participants With Response to Treatment|Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.|Baseline up to Week 16|Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation.|||proportion of participants|||Number
2797903|NCT00537199|Primary|Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone|"Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.~Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye."|Following two (2) scheduled visits for visual examination, up to one month following first exam|No analysis was performed. Study was terminated by sponsor.||||||
2797908|NCT00537082|Secondary|Annualized Relapse Rate (ARR) at 6 Months|Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.|6 Months|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.|||Relapses per year|||Number
2797909|NCT00537082|Secondary|Number of Patients Free of New or Newly Enlarged T2 Lesions|The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.|up to Month 3 and up to Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.|||Participants|||Number
2797910|NCT00537082|Secondary|Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)|A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).|up to Month 6|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.|||Participants|||Number
2797911|NCT00537082|Primary|Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6|Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.|Month 3 and Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.|||Participants|||Number
2797912|NCT00537056|Secondary|Initial Tumor Size|Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.|pre-sunitinib therapy||||Participants|||Count of Participants
2797913|NCT00537056|Secondary|DCE MRI AUC Peak Flow|Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).|12 weeks||||Participants|||Count of Participants
2797914|NCT00537056|Secondary|Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan|Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.|12 weeks||||Participants|||Count of Participants
2797915|NCT00537056|Secondary|Tumor Size by Computed Tomography (CT) Scan|Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.|12 weeks||||Participants|||Count of Participants
2797916|NCT00537056|Secondary|Tumor Necrosis|The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.|12 weeks||||Participants|||Count of Participants
2797917|NCT00537056|Secondary|Adverse Events|Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.|up to 12 months||||adverse events|||Number
2797918|NCT00537056|Secondary|Initial Comprehensive Metabolic Panel|A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.|Prior to baseline DCE MRI||||Participants|||Count of Participants
2797919|NCT00537056|Secondary|Histopathology|Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.|1 day|Patients with renal cell carcinoma|||Participants|||Count of Participants
2797940|NCT00536913|Secondary|Use of Rescue Medication at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Inhalations||Standard Deviation|Mean
2797941|NCT00536913|Secondary|Percentage of Nights With Awakenings Due to Asthma|Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Percentage of nights||Standard Deviation|Mean
2797920|NCT00537056|Primary|F-18 FDG Tumor Uptake (SUV Max)|"The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism.~Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.~Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response."|12 weeks minus baseline|All patients underwent baseline F-18 FDG PET scan. Mean SUVmax at baseline is reported (row 1). 6 participants achieved progression-free survival after post-sunitinib therapy, and their SUVmax values were averaged (row 2). 11 participants had progression or recurrence/relapse of disease and their SUVmax values were averaged (row 3).|||SUVmax||Standard Deviation|Mean
2797921|NCT00537030|Secondary|Percentage of Participants Who Experienced Toxicities|The percentage of participants who experienced toxicities: Allergy rate, Hyperglycemia Rate, Pancreatitis Rate, Hemorrhage/Thrombosis Rate|up to 1 year|Patients who had toxicity data collected.|||percentage of participants|||Number
2797922|NCT00537030|Secondary|Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase|An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect.|At baseline, prior to doses 4, 5, and 6 and on days 15 and 22|no data available for this analysis.||||||
2797923|NCT00537030|Secondary|Determine if Plasma Asparagine is Adequately Depleted|Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions.|On days 12 or 13|No data available for this analysis.||||||
2797924|NCT00537030|Primary|Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL|Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase|48 hours post administration of Erwinia asparaginase|Of the 59 enrolled participants, there were 2 ineligible and 2 in-evaluable participants. From the remaining 55 participants, 52 participants had an acceptable sample that could be reported on.|||Percent of participants|||Number
2797925|NCT00537017|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 42 weeks|All participants who received treatment with study drug were included in the analysis.|||Participants|||Number
2797926|NCT00537017|Secondary|Total Sleep Time|Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175.|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
2797927|NCT00537017|Secondary|Absolute Duration of Dyskinesias|"Participant diaries recorded time spent in the on state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. On time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
2797928|NCT00537017|Secondary|"Time Spent in the on State Without Troublesome Dyskinesia"|"Participant diaries recorded time spent in the on state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. On time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
2797942|NCT00536913|Secondary|Asthma Symptoms at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks||||Units on a scale||Standard Deviation|Mean
2798863|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
2797929|NCT00537017|Secondary|"Time Spent in the on State With Troublesome Dyskinesias"|"Participant diaries recorded time spent in the on state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. On time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
2797930|NCT00537017|Secondary|"Time Spent in the on State With no Dyskinesias"|"Participant diaries recorded time spent in the on state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. On time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify an improvement in the Parkinson's disease symptoms (i.e., participant can move well) concomitant with no dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
2797931|NCT00537017|Secondary|"Awake Time Per Day in the on State"|"Participant diaries recorded time spent in the on state at half-hourly intervals for at least 3 full days before scheduled visits. On time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Higher on time values relative to BL mean that the Parkinson's disease symptoms are better or absent (i.e., participant can move well). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||hours/day||Standard Deviation|Mean
2797932|NCT00537017|Secondary|"Time Spent in Off State Per Day"|"Participant diaires recorded time spent in the off state at half-hourly intervals for at least 3 full days before scheduled visits. Off time is defined as when the participant's medication is not working as subjectively determined by the participant and his/her physician. Higher off time values relative to Baseline (BL) signify that the Parkinson's disease symptoms are worse (i.e., participant can only move slowly or not at all). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.|||Hours/day||Standard Deviation|Mean
2797933|NCT00536991|Secondary|Objective Tumor Response, Assessed by RECIST|Judged by monthly physical exam and radiographic evaluation. Patients will be considered evaluable for tumor response if they have at least two post-baseline tumor assessments at least 4 weeks apart, received study medication for 8 weeks or if they have evidence of disease progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 years|All treated and eligible patients. 26 patients were not evaluable.|||percentage of participants||95% Confidence Interval|Number
2797934|NCT00536991|Secondary|Incidence of Toxicity Graded According to the National Cancer Institute CTC Version 3.0|Count of participants with serious adverse event. Please refer to the adverse event reporting for more detail.|Up to 11 years|All treated and eligible patients|||Participants|||Count of Participants
2797935|NCT00536991|Primary|PSA Response Rate|Patients will be considered evaluable for PSA response if they have at least two post-baseline PSA measurements at least 4 weeks apart, or if they have other evidence of disease progression. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy.|Up to 11 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2797936|NCT00536991|Primary|Determine the Maximum Tolerated Dose (MTD)|Determine the maximum tolerated dose (MTD) of oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole (400 mg thrice daily [TID]) + oral hydrocortisone (20 mg AM, 10 mg PM)|up to 11 years|All Phase I participants|||mcg|||Number
2797937|NCT00536978|Secondary|One-year Disease-free Survival (DFS)|Efficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.|1 Year|||||||
2797938|NCT00536978|Primary|6-month Treatment Related Mortality (TRM)|Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.|6 Months|Of the 22 patients enrolled, none received the adback T-Cell or NK cells treatment.|||participants|||Number
2797939|NCT00536913|Secondary|Use of Rescue Medication at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Inhalations||Standard Deviation|Mean
2797943|NCT00536913|Secondary|Asthma Symptoms at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks||||Units on a scale||Standard Deviation|Mean
2797944|NCT00536913|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Liters/min||Standard Deviation|Mean
2797945|NCT00536913|Secondary|Morning Peak Expiratory Flow (mPEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks||||Liters/min||Standard Deviation|Mean
2797946|NCT00536913|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.|At baseline, at 2 weeks and 4 weeks||||Liters||Full Range|Mean
2797947|NCT00536913|Primary|Urinary Free Cortisol (UFC)|Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment|At baseline and 4 weeks||||Ratio||Full Range|Geometric Mean
2797948|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy|Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy|Baseline and 2 years||||percent change||Full Range|Median
2797949|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy|Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy|Baseline and 2 years||||percent change||Full Range|Median
2797950|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy||Baseline and 2 years||||U/ml||Full Range|Median
2797951|NCT00536874|Secondary|RECIST Radiologic Response to Neoadjuvant Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|2 years||||participants|||Number
2797952|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy||Baseline and 2 years||||ng/ml||Full Range|Median
2797953|NCT00536874|Secondary|Overall Survival (Follow-Up Time)||From Baseline until 2 Years and Follow-Up, up to 120 months||||months||Full Range|Median
2797954|NCT00536874|Primary|Overall Survival at 18 Months|Percentage of participants that were alive or survived at 18 months after randomization|18 months||||percentage of participants||95% Confidence Interval|Number
2797955|NCT00536809|Secondary|Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797956|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine Clearance|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797957|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797958|NCT00536809|Secondary|Change From Baseline to Study Completion in Sodium, Potassium, and Calcium|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797959|NCT00536809|Secondary|Change From Baseline to Study Completion in International Normalized Ratio|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797960|NCT00536809|Secondary|Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797961|NCT00536809|Secondary|Change From Baseline to Study Completion in White Blood Cells and Platelets|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797962|NCT00536809|Secondary|Change From Baseline to Study Completion in Hemoglobin and Neutrophils|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797963|NCT00536809|Secondary|Change From Baseline to Study Completion in Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797964|NCT00536809|Secondary|Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797965|NCT00536809|Secondary|Change From Baseline to Study Completion in Weight|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||||||
2797966|NCT00536809|Secondary|Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II|Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days)|All-Treated Population for Phase II||||||
2797967|NCT00536809|Secondary|Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs|This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent.|Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible|Participants in the All-Treated Population who signed a PGx informed consent.||||||
2797968|NCT00536809|Secondary|Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy|DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3.|All-Treated population for Phase II||||||
2797969|NCT00536809|Secondary|Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment|Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days.|All-Treated population for Phase II||||||
2797970|NCT00536809|Secondary|Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response|A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible).|All-Treated population for Phase II||||||
2797971|NCT00536809|Secondary|Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies.|Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening.|All-Treated population for Phase II||||||
2797972|NCT00536809|Primary|Overall Response in Phase II|The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study.|Baseline to response (up to 135 days)|All-Treated Population for Phase II: all participants who received at least one dose of lapatinib|||participants|||Number
2797973|NCT00536744|Secondary|Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application||12 weeks post initial application and 24 weeks post initial application|||||||
2797974|NCT00536744|Primary|The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.||12 weeks post initial application|ITT|||participants||95% Confidence Interval|Number
2797975|NCT00536731|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)|Baseline to 6 weeks||||Liters||Standard Deviation|Mean
2797976|NCT00536731|Secondary|Percentage of Rescue Free Days|Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.|Baseline to 6 weeks||||Percentage of days||Standard Deviation|Mean
2797977|NCT00536731|Secondary|Percentage of Asthma Control Days|Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.|Baseline to 6 weeks||||Percentage of days||Standard Deviation|Mean
2797978|NCT00536731|Secondary|Percentage of Symptom-free Days|Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.|Baseline to 6 weeks||||Percentage of days||Standard Deviation|Mean
2797979|NCT00536731|Secondary|Use of Rescue Medication, Total|Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks||||Inhalations||Standard Deviation|Mean
2797980|NCT00536731|Secondary|Use of Rescue Medication, Day|Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks||||Inhalations||Standard Deviation|Mean
2797981|NCT00536731|Secondary|Use of Rescue Medication, Night|Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks||||Inhalations||Standard Deviation|Mean
2797982|NCT00536731|Secondary|Percentage of Nights With Awakenings Due to Asthma|"Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered Yes or No whether she/he woke up during the night due to asthma."|Baseline and 6 weeks||||Percentage of night||Standard Deviation|Mean
2797983|NCT00536731|Secondary|Asthma Symptom Score, Total|Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
2797984|NCT00536731|Secondary|Asthma Symptom Score, Day|Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
2797985|NCT00536731|Secondary|Asthma Symptom Score, Night|Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
2797986|NCT00536731|Secondary|Evening Peak Expiratory Flow (PEF)|Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks||||Liters/min||Standard Deviation|Mean
2797987|NCT00536731|Primary|Morning Peak Expiratory Flow (PEF)|Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks||||Liters/min||Standard Deviation|Mean
2797988|NCT00536575|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.|24 months||||percentage of participants|||Number
2797989|NCT00536510|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks|Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797990|NCT00536510|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks|Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2797991|NCT00536484|Secondary|Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline|"The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement.~Change: mean at observation minus mean at baseline."|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).~Number analyzed=participants at Week 12 LOCF"|||scores on a scale||Standard Error|Least Squares Mean
2797992|NCT00536484|Secondary|Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline|"UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet [without leaking]). Improvement: positive score change; No change: score change=0; Deterioration: negative score change"|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.~Number analyzed=participants at Week 12 LOCF."|||percentage of participants|||Number
2797993|NCT00536484|Secondary|Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline|PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.~Number analyzed=participants at Week 12 LOCF."|||percentage of participants|||Number
2797994|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.~Change: mean at Week 12 minus mean at baseline."|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"|||scores on a scale||Standard Error|Least Squares Mean
2797995|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.~Change: mean at Week 12 minus mean at baseline"|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"|||scores on a scale||Standard Error|Least Squares Mean
2797996|NCT00536484|Secondary|Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline|Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).~Number analyzed=participants at Week 12 LOCF."|||scores on a scale||Standard Error|Least Squares Mean
2797997|NCT00536484|Secondary|Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Nocturnal Urgency Episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2797998|NCT00536484|Secondary|Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Nocturnal Micturitions >0 per 24 and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2797999|NCT00536484|Secondary|Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline|Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2798000|NCT00536484|Secondary|Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only those with at least 1 episode during baseline 3-day diary period were included.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2798001|NCT00536484|Secondary|Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Urgency Episodes >0 per 24 hours and non missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2798002|NCT00536484|Secondary|Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.~Change: mean at observation minus mean at baseline"|Baseline, Week 2 and Week 6|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2 or Week 6 (last observation carried forward [LOCF]).~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline (n=placebo; n=fesoterodine)"|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2798003|NCT00536484|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.~Change: mean at Week 12 minus mean at Baseline"|Baseline and Week 12|Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward [LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.|||number of episodes per 24 hours||Standard Error|Least Squares Mean
2798004|NCT00536471|Secondary|Summary of Adverse Events Leading to Discontinuation||over 9 months|Number of randomized participants in each treatment group.|||participants|||Number
2798005|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
2798006|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months||over 9 months|Number of participants with a normal baseline at at least one post-baseline measurement.|||participants|||Number
2798007|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint|The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.|over 3 months|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
2798008|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin||Baseline, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||millimoles per Liter (iron)||Standard Deviation|Least Squares Mean
2798009|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase||baseline, 9 months|Number of participants with non-missing data at baseline and at least one post baseline visit.|||Units per Liter||Standard Deviation|Least Squares Mean
2798010|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least post-baseline visit.|||Billions per Liter||Standard Deviation|Least Squares Mean
2798011|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||millimole per Liter||Standard Deviation|Least Squares Mean
2798012|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||femtoliter||Standard Deviation|Least Squares Mean
2798013|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||Proportion of 1.0||Standard Deviation|Least Squares Mean
2798014|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.|||micromole per Liter||Standard Deviation|Least Squares Mean
2798015|NCT00536471|Secondary|Abnormal Vital Signs at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
2798016|NCT00536471|Secondary|Abnormal Vital Signs at 12 Week Endpoint||12 weeks|Number of participants with a normal baseline and at least one post-baseline measurement.|||participants|||Number
2798017|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 9 Months||over 9 months|Number of participants with a normal baseline and at least oone post-baseline measurement.|||participants|||Number
2798018|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 12 Weeks||over 12 weeks|Number of participants wtih a normal baseline and at least one post-baseline measurement.|||participants|||Number
2798019|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Weight||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||kilograms||Standard Error|Least Squares Mean
2798020|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||beats per minute||Standard Error|Least Squares Mean
2798021|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure|Sitting systolic and diastolic blood pressure.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||mm Hg||Standard Error|Least Squares Mean
2798022|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score|A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798023|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)|A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798024|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798025|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)|Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Deviation|Least Squares Mean
2798026|NCT00536471|Secondary|Probability of Response at 12 Week Endpoint|Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||probability of response||Standard Error|Least Squares Mean
2798027|NCT00536471|Secondary|Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint|Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||probability of remission||Standard Error|Least Squares Mean
2798028|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Deviation|Least Squares Mean
2798029|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|Over 12 weeks||||percent of total effect|||Number
2798030|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score|Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.|over 12 weeks||||coefficient|||Number
2798031|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|over 12 weeks||||percent of total effect|||Number
2798032|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7|Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.|Over 12 weeks||||coefficient|||Number
2798033|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798034|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798035|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798036|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798037|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness|Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798038|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness|Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798039|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness|Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798040|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms|Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798041|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms|Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798042|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization|Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798043|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity|Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798044|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation|Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798045|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight|Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798046|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight|Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798047|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis|Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798048|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms|Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798049|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General|Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798050|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal|Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798051|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)|Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798052|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)|Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798053|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation|Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798054|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation|Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798055|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798056|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late|Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798057|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle|Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798058|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early|Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798059|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide|Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).|Baseline, 12 weeks, 9 Months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798060|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt|Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798061|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood|Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798062|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798063|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.|Baseline, 8 weeks, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798064|NCT00536471|Primary|Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|baseline, 8 weeks|Number of participants with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2798065|NCT00536380|Primary|Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg|"The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was reflective, covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period."|Baseline and 4 treatment weeks|Intent to treat population|||Units on a scale||Standard Error|Least Squares Mean
2798066|NCT00536341|Secondary|Overall Survival|Defined as the time from Day 1 of treatment administration to date of death from any cause, estimated using Kaplan-Meier methods.|Every 3 months until treatment discontinuation, expected average of 6 months and then every 6 months thereafter up to 5 years|All treated patients, all dose levels|||months||95% Confidence Interval|Median
2798067|NCT00536341|Secondary|Progression-Free Survival|Measured from first treatment to disease progression and assessed using Kaplan-Meier methods.|Every 3 months during treatment until disease progression and every 6 months thereafter, up to 5 years|All treated patients, all dose levels|||months||95% Confidence Interval|Median
2798068|NCT00536341|Primary|Complete Response Rate|An improvement in complete response to at least 60% following treatment, assessed using CT scans, clinical/lab examinations, and bone marrow aspirations, as defined by National Cancer Institute Working Group Response Criteria.|At 12 weeks during treatment and 2 months post-treatment until disease progression, projected 8 months|All patients deemed evaluable and evaluated for response|||participants|||Number
2798069|NCT00536341|Primary|Number of Adverse Events as a Measure of Safety and Tolerability|Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|63 months|All treated patients|||participants|||Number
2798172|NCT00535405|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline and 12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent change in LDL-C||95% Confidence Interval|Least Squares Mean
2798070|NCT00536263|Secondary|Change From Baseline in Liver Biopsy Score|"Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):~Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).~Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).~Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of~inflammatory cells in >2/3 of portal tracts]).~Score IV (fibrosis): 0 (none) to 4 (cirrhosis)."|Baseline to 24 weeks after end of treatment|Treated participants from designated sites|||Units on a scale||Standard Deviation|Mean
2798071|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBs) Seroconversion|HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798072|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBsAg) Loss|HBsAg Loss was tested by assay of Abbott MEIA|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798073|NCT00536263|Secondary|Number of Participants With Combined Response|Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798074|NCT00536263|Secondary|Number of Participants With Biochemical Response|Biochemical response was defined as alanine aminotransferase (ALT) normalization.|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798075|NCT00536263|Secondary|Number of Participants With HBV-DNA Undetectable|Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798076|NCT00536263|Secondary|Number of Participants With HBV-DNA < 200 IU/mL|HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798077|NCT00536263|Secondary|Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL|"HBV-DNA was tested by assay of Roche Cobas Taqman (the test~lowest limit is 6 IU/mL)"|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798078|NCT00536263|Secondary|HBe Seroconversion|HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.|End of treatment (EOT) and 24 weeks after EOT|Treated participants|||Participants|||Number
2798079|NCT00536263|Secondary|Number of Participants With HBeAg Loss|HBeAg Loss was tested by assay of Abbott MEIA|Up to Treatment Week 48|Treated participants|||Participants|||Number
2798080|NCT00536263|Primary|Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss|HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)|24 weeks after end of treatment (EOT)|Treated participants|||Participants|||Number
2798081|NCT00536198|Secondary|Clinical Global Impressions-Improvement (CGI-I)|The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement.|Cycle 1 to Cycle 6|all participants who were measured at a visit past baseline were analyzed|||units on a scale||Standard Deviation|Mean
2798082|NCT00536198|Secondary|DRSP Anger/Irritability Subscale|Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
2798083|NCT00536198|Secondary|DRSP Physical Subscale|Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
2798084|NCT00536198|Secondary|DRSP Depression Subscale|Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
2798085|NCT00536198|Primary|DRSP|DRSP (Daily Rating of Severity Problems) is composed of 21 items reflecting the 11 candidate symptoms for PMDD according to DSM IV and DSM V. Each symptom is scored 1-6. A diagnosis of PMDD requires a minimum average luteal phase score of greater than or equal to 3 (mild) for at least 5 PMDD symptoms during the five most symptomatic of the final seven luteal phase days and the first two days of menses onset, and we require that the average follicular phase score not be >2 on these same items. The minimum score is 0 and maximum is 126 for the total score. A higher score indicates greater severity of symptoms.|Baseline to Cycle 6||||units on a scale||Standard Deviation|Mean
2798086|NCT00536198|Primary|Number of Symptomatic Days Before Pills Were Taken|"Symptomatic days were those that participant experienced at least 3 symptoms at a severity of at least 3, which is a mean of at least mild."|Cycle 1 to Cycle 6|all enrolled participants were analyzed|||days||Standard Deviation|Mean
2798087|NCT00536198|Primary|Number of Days Pills Were Taken|The number of days that pills were taken on.|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed|||number of days||Standard Deviation|Mean
2798088|NCT00536198|Other Pre-specified|Adverse Events|A measurement of frequency of adverse events by random assignment|Baseline through Cycle 6|all enrolled participants were analyzed|||participants|||Number
2798089|NCT00536198|Secondary|Clinical Global Severity (CGI-S)|Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe.|Baseline through Cycle 6|all participants enrolled analyzed|||units on a scale||Standard Deviation|Mean
2798090|NCT00536198|Primary|Michelson SSRI Withdrawal Checklist|Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed|||units on a scale||Standard Deviation|Mean
2798091|NCT00536198|Primary|Inventory of Depression Symptoms (IDS-C)|Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic.|Measured from baseline to Cycle 6|all participants enrolled were analyzed|||units on a scale||Standard Deviation|Mean
2798092|NCT00536198|Primary|Premenstrual Tension Scale (PMTS)|The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems|Measured from baseline to Cycle 6|all randomized participants|||units on a scale||Standard Deviation|Mean
2798093|NCT00536172|Primary|Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)|Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression.|Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28|Evaluable subjects|||participants|||Number
2798094|NCT00536120|Secondary|Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6|Alpha4-integrin expression is the mean fluorescent intensity (MFI), a measure of fluorescence intensity often used to monitor changes in surface antigen modulation in flow cytometry. There is no reference range for this test, which was developed at Biogen Idec.|Month 0 (Baseline), Month 3, and Month 6|Participants who had received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.|||mean fluorescent intensity (MFI)||Standard Deviation|Mean
2798095|NCT00536120|Secondary|Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6|Measurement of the degree of natalizumab saturation of the alpha4 integrin on peripheral blood mononuclear cells was accomplished by staining cells with phycoerythrin conjugated anti human IgG4 antibody (hIgG4-PE) to label the cell-bound natalizumab, followed by flow cytometric detection and quantification.|Month 0 (Baseline), Month 3, and Month 6|Participants who received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.|||percent saturation||Standard Deviation|Mean
2798096|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 6|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.|||percent change||Standard Deviation|Mean
2798097|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 3|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.|||percent change||Standard Deviation|Mean
2798098|NCT00536120|Primary|Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination|Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28 and a pre-immunization antibody value ≤ 3.5 IU/mL. No imputation methods were used in the primary analyses.|||percentage of participants|||Number
2798099|NCT00536120|Primary|Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination|KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28. No imputation methods were used in the primary analyses.|||percentage of participants|||Number
2798100|NCT00536107|Primary|Number of Patients With Serious Adverse Events (SAEs)||From time consent was given to 28 days after last dose||||participants|||Number
2798101|NCT00536107|Primary|Number of Patients With Adverse Event (AE)||From time consent was given to 28 days after last dose of study drug.|Evaluable for Safety population: All patients who recived at least one dose of study drug|||Participants|||Number
2798102|NCT00535938|Secondary|Concurrent Surgical Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study|||Patients|||Number
2798103|NCT00535938|Secondary|Concurrent Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study|||Patients|||Number
2798104|NCT00535938|Secondary|"BOTOX® Dose in Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798105|NCT00535938|Secondary|BOTOX® Dose in Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798106|NCT00535938|Secondary|BOTOX® Dose in Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798107|NCT00535938|Secondary|BOTOX® Dose in Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798108|NCT00535938|Secondary|BOTOX® Dose in Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798109|NCT00535938|Secondary|BOTOX® Dose in Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798110|NCT00535938|Secondary|BOTOX® Dose in Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Units||Standard Deviation|Mean
2798111|NCT00535938|Primary|"Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person's preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician's discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798112|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798113|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798173|NCT00535392|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.|||Consecutive doses||Standard Deviation|Mean
2798114|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798115|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798116|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798117|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point|||Scores on a Scale||Standard Deviation|Mean
2798118|NCT00535873|Primary|Overall Response Rate (ORR)|ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes >1500/µL, platelets >100,000/µL, hemoglobin >11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets >100,000/µL or 50% improvement ; Hemoglobin >11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.|From 3 cycles (90 days) up to 6 cycles (approximately 180 days)||||participants|||Number
2798119|NCT00535847|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline through Week 48|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||participants|||Number
2798174|NCT00535392|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
2798120|NCT00535847|Secondary|Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response|Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.|Baseline up to Week 72|The FA set included subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]). Data was presented for overall subjects based on eRVR and SVR status as per planned analysis.|||participants|||Number
2798121|NCT00535847|Secondary|Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|48 weeks after completion of treatment (up to Week 96)|Analysis population included subjects who completed assigned treatment in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
2798122|NCT00535847|Secondary|Percentage of Subjects With End of Treatment Response|Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|End of treatment (up to Week 48)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
2798123|NCT00535847|Secondary|Percentage of Prior Relapsers With Undetectable HCV RNA|Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|Analysis population included all enrolled subjects who were prior relapsers in parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) and received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
2798124|NCT00535847|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).|||percentage of participants||95% Confidence Interval|Number
2798125|NCT00535821|Primary|Mortality|In-hospital mortality|hospital||||participants|||Number
2798126|NCT00535782|Primary|Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||meters/second||Standard Deviation|Mean
2798127|NCT00535782|Secondary|Number of Participants Experiencing Adverse Events (AEs)|"A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity.~A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes.~AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke."|Up to Week 24|The safety population includes all patients who received any part of an infusion of study drug and who provided at least one assessment of safety. Randomized patients who received the incorrect therapy from that intended are summarized in the group according to the therapy actually received.|||participants|||Number
2798128|NCT00535782|Secondary|Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||meters/second||Standard Deviation|Mean
2798129|NCT00535782|Secondary|Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||nmol/L||Standard Deviation|Mean
2798130|NCT00535782|Primary|Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.|||nmol/L||Standard Deviation|Mean
2798131|NCT00535769|Secondary|Recalled Frequency of Sunscreen Application|The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered)|6 weeks|All participants were assessed|||units on a scale||Standard Deviation|Mean
2798132|NCT00535769|Secondary|Usefulness of Text Messaging System|Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful)|6 weeks|Patients with text messaging system included in analysis|||units on a scale||Standard Deviation|Mean
2798133|NCT00535769|Primary|Number of Days the Subjects Are Adherent to Using Sunscreen|Participants' adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.|6 weeks|All participants were analyzed|||days||95% Confidence Interval|Mean
2798134|NCT00535743|Secondary|Number of Participants Experiencing an Adverse Event|The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.|Up to 7 days following administration of study treatment|Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec’d 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec’d 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).|||Participants|||Count of Participants
2798135|NCT00535743|Secondary|Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7|"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to 180 minutes following administration of study treatment|Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation.|||minutes||Standard Deviation|Mean
2798136|NCT00535743|Secondary|Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8|"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to 200 minutes following administration of study treatment|Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation.|||minutes||Standard Deviation|Mean
2798137|NCT00535743|Primary|Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9|"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to 240 minutes following administration of study treatment|Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation. Additionally, N=1 participant was excluded from Arm M due to missing data and N=1 participant was excluded from Arm N due to unreliability of the neuromuscular data.|||minutes||Standard Deviation|Mean
2798138|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
2798139|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
2798140|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
2798141|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.|||micrograms/mL||95% Confidence Interval|Geometric Mean
2798142|NCT00535730|Primary|Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.|"GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23.~gpELISA = glycoprotein enzyme-linked immunosorbent assay."|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2798143|NCT00535730|Secondary|Safety and Tolerability of Both Vaccines When Administered Concomitantly.|All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events.|Eight weeks postvaccination|All subjects who received at least one vaccination|||Participants|||Number
2798144|NCT00535730|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|"GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.~*gpELISA = glycoprotein enzyme-linked immunosorbent assay"|4 weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.|||gpELISA units*/mL||95% Confidence Interval|Geometric Mean
2798145|NCT00535652|Primary|Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours||||mg/kg||Standard Deviation|Mean
2798146|NCT00535652|Secondary|Safety Assessment||0 to approx. 14 days after admission|||||||
2798147|NCT00535652|Primary|Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..||3 to 6 hours after a single dose of 1 gram ertapenem I.V..|||||||
2798148|NCT00535626|Secondary|Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative|The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-op, 3 month, 1, 2, 3, 4, 5 years|Participants/hips with available data. Overall number of participants and hips analysed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2798149|NCT00535626|Secondary|Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction|Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.|3 month, 1, 2, 3, 4, 5 years|Participants/hips are based on evaluable films for this data point. Overall number of participants and hips is based upon the 3 month population.|||hips|hips||Count of Units
2798150|NCT00535626|Secondary|Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones|Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.|3 month, 1, 2, 3, 4, 5 years|Participants/hips are based on evaluable films for this data point. Overall number of participants and hips analyzed is based upon the 3 month population.|||hips|hips||Count of Units
2798151|NCT00535626|Secondary|Change in SF-36 From Pre-operative to Post-operative Visits|The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-op, 3 month, 1, 2, 3, 4, 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2798152|NCT00535626|Secondary|Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits|The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.|pre-op, 3 month, 1, 2, 3, 4, 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2798153|NCT00535626|Primary|Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation||5 years post-operative|No cases were pending revision.|||hips|hips||Count of Units
2798154|NCT00535613|Secondary|Number of Participants Who Received Medication in the Recovery Room||up to 1 hour post surgery||||Participants|||Count of Participants
2798155|NCT00535613|Secondary|Time Spent in Recovery Room||up to 1 hour post surgery|The study team planned to collect post anesthesia care unit discharge time from the subject medical records, however PACU discharge time was often not recorded in routine cases during the study period. This was not anticipated by the study team and retrospective analysis was not possible for this outcome.||||||
2798156|NCT00535613|Primary|Number of Participants With Emergent Agitation|Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)|up to 30 min post surgery||||Participants|||Count of Participants
2798157|NCT00535587|Secondary|Improvement of Fibromyalgia Symptoms||6 months|||||||
2798158|NCT00535587|Primary|Levels of Growth Hormone Post Exercise|Serum growth hormone at peak V02/treadmill|6 months|ITT|||ng/ml||Standard Deviation|Mean
2798159|NCT00535496|Primary|Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex|The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 3 minutes after administering sugammadex|The ITT population: all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias; their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed. The 1.0 mg/kg group was not evaluated.|||Minutes||95% Confidence Interval|Mean
2798160|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)|Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|up to 2 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 1.0 mg/kg were not evaluated for this outcome measure.|||Minutes||Standard Deviation|Mean
2798161|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.|||Minutes||Standard Deviation|Mean
2798162|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.8 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.|||Minutes||Standard Deviation|Mean
2798175|NCT00535392|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
2798176|NCT00535301|Secondary|Vaginal Mesh Exposure|Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.|perioperative||||participants|||Number
2798163|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS|Neuromuscular function was monitored by applying repetitive TOF stimulations manually to the ulnar nerve of one forearm every 15 seconds & the number of twitches collected manually at the adductor pollicis muscle with the PNS by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 1.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 5 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 4.0 mg/kg were not evaluated for this outcome measure.|||Minutes||Standard Deviation|Mean
2798164|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T4 is the fourth twitch after TOF nerve stimulation. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 7 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.|||Minutes||Standard Deviation|Mean
2798165|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 1.0 mg/kg sugammadex are presented where the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 150 minutes after administering sugammadex|The ITT population: randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant was not analyzed as the time of recovery was judged unreliable. The 4.0 mg/kg group was not evaluated.|||Minutes||Standard Deviation|Mean
2798166|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 4 minutes after administering sugammadex|The Intent-To-Treat (ITT) population: randomized, received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed.The 1.0 mg/kg group was not evaluated.|||Minutes||Standard Deviation|Mean
2798167|NCT00535405|Secondary|Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
2798168|NCT00535405|Secondary|Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12|Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.|12 Weeks|Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
2798169|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12||12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
2798170|NCT00535405|Secondary|Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
2798171|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12||12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent of Patients||Standard Error|Mean
2798178|NCT00535301|Primary|Recurrent Stage II or Greater Anterior Vaginal Prolapse|Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.|three years|Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1.|||participants|||Number
2798179|NCT00535288|Secondary|Change From Baseline in WHQ Vasomotor Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for vasomotor symptoms.|||Score on a scale||Standard Deviation|Mean
2798180|NCT00535288|Secondary|Change From Baseline in Women's Health Questionnaire (WHQ) Sleep Problems Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Sleep problems encompass Items 1, 11, and 29 of the 36 total items. The transformed sums of items 1, 11, and 29 were divided by 3 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for sleep problems.|||Score on a scale||Standard Deviation|Mean
2798181|NCT00535288|Secondary|Total Number of Remitters by Week|A participant was defined as a (hot flush) remitter for a study week if at most one moderate/severe vasomotor symptom per day on average was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-remitter.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week. An LOCF approach was used.|||Participants|||Number
2798182|NCT00535288|Secondary|Total Number of Responders by Week|A participant was defined as a (hot flush) responder for a study week if a reduction of at least 50% for average daily frequency of moderate/severe vasomotor symptoms (hot flushes) (Frequency Score A) compared to Baseline was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-responder. An LOCF approach was used.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Participants|||Number
2798183|NCT00535288|Secondary|Change From Baseline in Average Daily Mild to Severe Composite Symptoms Score (Composite Score B) by Week|Composite Score B was calculated as Severity Score B x Frequency Score B.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Composite score||Standard Deviation|Mean
2798184|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Mild to Severe Vasomotor Symptoms (Severity Score B) by Week|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score B was calculated as the number of mild hot flushes + the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of all hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
2798185|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Mild to Severe Vasomotor Symptoms (Frequency Score B) by Week|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score B was based on the number of mild hot flushes + the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
2798186|NCT00535288|Secondary|Change From Baseline in Average Daily Moderate/Severe Composite Score (Composite Score A) by Week|Composite Score A was calculated as Severity Score A x Frequency Score A.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Composite score||Standard Deviation|Mean
2798187|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
2798188|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) by Week Excluding Weeks 4 and 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
2798189|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) by Week Excluding Weeks 4 and 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
2798190|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
2798191|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Severity score||Standard Deviation|Mean
2798192|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The Intent-to-Treat (ITT) population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.|||Events per day||Standard Deviation|Mean
2798193|NCT00535262|Primary|Reduction of Depression CGI Score (<= 2)|"HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire~0 participants analyzed due to early termination of study."|8 weeks|||||||
2798864|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|4 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
2798194|NCT00535236|Secondary|Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC|Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized.|Up to 28 days post any vaccination (up to ~118 days)|All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.|||Percentage of Participants|||Number
2798195|NCT00535236|Secondary|Percentage of Participants With a Systemic Adverse Event Prompted on the VRC|An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized.|Up to 28 days post vaccination 4 (up to ~118 days)|All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.|||Percentage of Participants|||Number
2798196|NCT00535236|Secondary|Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)|An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized.|Up to Day 5 post any vaccination|All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.|||Percentage of Participants|||Number
2798197|NCT00535236|Primary|Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)|An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.|up to 28 days post vaccination 4 (up to ~Day 118)|All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.|||Percentage of Participants|||Number
2798198|NCT00535236|Primary|Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay|Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination|Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)|All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination IFN-g data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.|||Ratio||90% Confidence Interval|Geometric Mean
2798199|NCT00535236|Primary|Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)|Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination|Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)|All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination gpELISA data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.|||Ratio||90% Confidence Interval|Geometric Mean
2798200|NCT00535223|Secondary|Posttraumatic Cognitions Inventory (PTCI)|This 36 item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. Each item is rated between 1 ( Totally Disagree) to 7 ( Totally Agree). The best score would be 36, indicating that the participant totally did not agree with any of the thoughts that have been associated with PTSD. The worse score would be 252, which would indicate that the participant totally agreed with all of the cognitions that have been associated with PTSD|Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment||||units on a scale||Standard Deviation|Mean
2798201|NCT00535223|Primary|Clinician Administered PTSD Scale (CAPS)|This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.|Pre treatment, Post treatment (16 weeks) and One year post treatment|Pre-tx Post-tx 1-yr F.U. N M SD Range N M SD Range N M SD Range GBET 41 82.44 15.09 55-107 41 71.73 20.55 34-105 35 69.29 20.71 24-107 PCGT 40 81.18 14.31 52-109 40 75.43 23.01 18-122 33 71.03 22.80 37-121|||units on a scale||Standard Deviation|Mean
2798202|NCT00535145|Primary|The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER|Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.|Day 1 - Day 62|Safety Analysis Set|||Participants|||Number
2798865|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
2798203|NCT00535145|Secondary|Personal and Social Performance Score (PSP) Change From Baseline|The PSP (range 1-100) is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Day 1 - Day 62|Includes participants in the efficacy analysis set for with PSP scores available.|||Scores on a scale||Standard Deviation|Mean
2798204|NCT00535145|Secondary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.|Day 1 - Day 62|Efficacy Analysis Set|||Scores on a scale||Standard Deviation|Mean
2798205|NCT00535145|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline|"The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale (1=Absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate/Severe, 6=Severe, 7=Extreme).The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia."|Day 1 - Day 62|Efficacy Analysis Set|||Scores on a scale||Standard Deviation|Mean
2798206|NCT00535132|Secondary|Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint|The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798207|NCT00535132|Secondary|Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint|The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798208|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Scores on a scale||Standard Deviation|Mean
2798209|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Scores on a scale||Standard Deviation|Mean
2798210|NCT00535132|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint|"The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states taking all things into account, how satisfied or dissatisfied are you with this medication? and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100."|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798211|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
2798212|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
2798866|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
2798213|NCT00535132|Other Pre-specified|Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Worst value is 7 and best value is 1."|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798214|NCT00535132|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint|The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798215|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 4|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
2798216|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 2|Intent-to-Treat Population with non-missing values at this timepoint|||Participants|||Number
2798217|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798218|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 4|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798219|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 2|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798220|NCT00535132|Primary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)|Intent-to-Treat Population with non-missing values at this timepoint|||Points on a scale||Standard Deviation|Mean
2798221|NCT00535002|Primary|Cocaine Craving|"Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure.~The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely."|Post cocaine cue exposure||||units on a scale||Standard Deviation|Mean
2798222|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 24 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Participants|||Number
2798223|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 2 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||participants|||Number
2798387|NCT00534235|Secondary|Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm|Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.|5 years||||Participants|||Count of Participants
2798224|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose|This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication.|0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Minutes||Standard Deviation|Mean
2798225|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose|"This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.~Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins.~The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication."|0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Minutes||Standard Deviation|Mean
2798226|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||percent fall * minute||Standard Deviation|Mean
2798227|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||percent fall * minute||Standard Deviation|Mean
2798228|NCT00534976|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||percent fall in FEV1||Standard Deviation|Mean
2798229|NCT00534976|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.|||Percent fall in FEV1||Standard Deviation|Mean
2798230|NCT00534937|Secondary|Time to Healing of the Venous Stasis Ulcer|Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).|Baseline to 12 weeks|Time to healing can only evaluate the patients that showed healing during the 12 week study therefore the number may not be consistent with other numbers.|||days||Standard Deviation|Mean
2798231|NCT00534937|Secondary|Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)||12 weeks|Number of participants who completed 12 weeks of treatment without healing. Also limb volume measures must have been present.|||percentage of change||Standard Deviation|Mean
2798232|NCT00534937|Secondary|Change in Wound Surface Area for Non Healed Subject at 12 Weeks.|Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.|12 weeks|The participants are those that didn't achieve complete wound healing after 12 weeks of treatment. The change from screening to week 12 in wound surface area is reported.|||cm2||Standard Deviation|Mean
2798233|NCT00534937|Primary|Complete Healing Rate of Venous Stasis Ulcers|Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.|12 weeks||||participants|||Number
2798234|NCT00534833|Secondary|Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.|||Participants|||Number
2798235|NCT00534833|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination|Day 28 post-vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2798236|NCT00534833|Primary|Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria.~Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio."|28 Days post-vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.|||Participants|||Number
2798237|NCT00534794|Secondary|Ocular Comfort Score at 12 Hours|Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.|12 hours||||units on a scale||Standard Deviation|Mean
2798238|NCT00534794|Primary|Change in Ocular Itch Score From Baseline|Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.|0 hours, 12 hours||||units on a scale||Standard Deviation|Mean
2798239|NCT00534703|Secondary|Function of Isolated Myocytes||6 months|Data not collected due to early termination of the trial||||||
2798240|NCT00534703|Secondary|Other Relevant Proteins e.g. Phospholamban, the Sarcoplasmic Reticulum Calcium Release Channel, the Na+/Ca2+-Exchanger.||6 months|Data not collected due to early termination of the trial||||||
2798241|NCT00534703|Secondary|Levels of SERCA2a Protein||6 months|Data not collected due to early termination of the trial||||||
2798242|NCT00534703|Secondary|Left Ventricular Function (LVEF)|Left ventricular function assessed by echocardiography and exercise capacity (6MWT, MVO2) during minimal LVAD support (low/no flow settings depending upon device) LVEF expressed as %|6 months|Note: The trial was terminated early with only 5 subjects enrolled. As a result, full statistical analysis for both primary and secondary outcomes was impossible and a more pragmatic approach was undertaken to assess product safety.|||Participants|||Count of Participants
2798243|NCT00534703|Secondary|Number of Participants With Exogenous Viral Vector Genome in the Myocardium Measured by qPCR for the Viral DNA|The trial was terminated early with only 5 subjects enrolled. As a result full statistical analysis for both primary and secondary outcomes was impossible and a more pragmatic approach was undertaken to assess product safety.|6 months||||Participants|||Count of Participants
2798244|NCT00534703|Primary|Overall Safety and Feasibility of Administering AAV1/SERCA2a to LVAD Patients|Safety is defined as the incidence of patients experiencing death and major adverse cardiovascular events, and out of range laboratory values. Both AAV1/SERCA2a treated cohorts (NAb+ and NAb-) will be compared to the placebo group.|6 months|The trial was terminated early with only 5 subjects enrolled. As a result full statistical analysis for both primary and secondary outcomes was impossible and a more pragmatic approach was undertaken to assess product safety.|||Participants|||Count of Participants
2798245|NCT00534638|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.|At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)|The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2798263|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798867|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
2798246|NCT00534638|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.|At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)|The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.|||Participants|||Count of Participants
2798247|NCT00534638|Secondary|Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO|"Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy.~Note: The analysis was performed based on the corrected demographical data. Please refer to the rationale provided in the Baseline characteristics section."|During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)|The analysis was performed on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2798248|NCT00534638|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO)|NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.|During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2798249|NCT00534638|Secondary|Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2798250|NCT00534638|Secondary|Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Dose 1 (at Day 0) until Month 12|The analysis was performed on the TVC - subset of male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B A Group male subjects for whom data were available.|||Participants|||Count of Participants
2798251|NCT00534638|Secondary|Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects|MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|From Dose 1 (at Day 0) until Month 12|This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.|||Participants|||Count of Participants
2798252|NCT00534638|Secondary|Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects|The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame.|Within 30 minutes following each vaccination dose|This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.|||Participants|||Count of Participants
2798253|NCT00534638|Secondary|Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day post-vaccination period|This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.|||Participants|||Count of Participants
2798264|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score|Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798868|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
2798254|NCT00534638|Secondary|Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day post-vaccination period following each dose and across doses|The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.|||Participants|||Count of Participants
2798255|NCT00534638|Secondary|Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day post-vaccination period following each dose and across doses|The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.|||Participants|||Count of Participants
2798256|NCT00534638|Secondary|Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types|The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).|At the time of Visit 5 (at 18.5 years of age)|The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.|||Participants|||Count of Participants
2798257|NCT00534638|Secondary|Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types|The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).|At the time of Visit 5 (i.e. at 18.5 years of age)|The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.|||Participants|||Count of Participants
2798258|NCT00534638|Secondary|Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types|The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).|At the time of Visit 5 (i.e. at 18.5 years of age)|The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.|||Participants|||Count of Participants
2798259|NCT00534638|Secondary|Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group|"The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group).~Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure."|At the time of Visit 5 (i.e. at 18.5 years of age)|The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.|||Participants|||Count of Participants
2798260|NCT00534638|Primary|Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group|The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).|At the time of Visit 5 (i.e. at 18.5 years of age)|The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.|||Participants|||Count of Participants
2798261|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||Participants|||Number
2798265|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798266|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Mean change from randomization||Standard Deviation|Mean
2798267|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Mean change from randomization||Standard Deviation|Mean
2798268|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score|"The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer.~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798269|NCT00534599|Secondary|Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Participants|||Number
2798270|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||Participants|||Number
2798271|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score|"The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798272|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score|The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798273|NCT00534599|Secondary|"Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8"|"This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'.~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||Participants|||Number
2798274|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score|"The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks||||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
2798275|NCT00534599|Primary|Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value."|Baseline (randomization) and then 8 weeks|Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.|||units on scale||95% Confidence Interval|Least Squares Mean
2798276|NCT00534495|Primary|Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS||At Weeks 0- 24||||events|||Number
2798277|NCT00534495|Secondary|Number of Participants With Presence of Systemic Features ( Fever, Rash)||At Weeks 4, 12 and 24|At week 4 ,Rilonacept 36 and Placebo 34 participants , at week 12 , Rilonacept 33 and 29 Placebo participants , and at week 24 combined group with 57 participants, at baseline Rilonacept 36 and Placebo 35 participants.|||participants|||Number
2798278|NCT00534495|Secondary|Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)|"Childhood Health Assesment Questionairre dissability index (C-HAQ)-DI, Disability Index Calculation:~The index is calculated by adding the scores for each of the categories and dividing by the number of categories answered. This gives a score in the 0 to 3.0 range. lower is better"|At Weeks 12 and 24|36 Rilonacept and 35 placebo at baseline , 36 Rilonacept and 34 placebo at week 4, 33 Rilonacept and 29 placebo at week 12, and 57 combined at week 24.|||units on a scale||Inter-Quartile Range|Median
2798279|NCT00534495|Secondary|Pediatric Quality of Life Inventory|Visual Analog Score (0-100 mm) 0 very well , 100 very poor|At Weeks 4, 12 and 24|At Week 4 ,36 Rilonacept and 34 Placebo patient. At week 12, Rilonacept 33 patients and Placebo 29.At baseline Rilonacept 36 and Placebo 35 participants.|||units on a scale||Inter-Quartile Range|Median
2798280|NCT00534495|Secondary|Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70||At Week 4 and week 12|Participants in the study at week 4 (rilonacept 35 and placebo 33).Participants in the study at week 12 ( Rilonacept 33 and placebo 29).|||participants|||Number
2798282|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Functioning)|The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available. Note that 4 items only had data available from 27 participants rather than 28.|||percentage of participants|||Number
2798283|NCT00534417|Post-Hoc|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.|14 patients had died, and 27 patients were censored in the OS analysis.|||Months||95% Confidence Interval|Median
2798284|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)|The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.|||percentage of participants|||Number
2798285|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Symptoms)|The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.|||percentage of participants|||Number
2798286|NCT00534417|Primary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.|21 patients had experienced disease progression, and three had died. 17 patients were censored in PFS analysis.|||Months||95% Confidence Interval|Median
2798287|NCT00534417|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after every 8 weeks of treatment||||percentage of participants||95% Confidence Interval|Number
2798288|NCT00534417|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment||||percentage of participants||95% Confidence Interval|Number
2798289|NCT00534417|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment||||participants|||Number
2798290|NCT00534417|Primary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.|21 patients had experienced disease progression. 20 patients were censored in TTP analysis. The 3 deaths in the PFS analysis were censored for the TTP analysis.|||Months||95% Confidence Interval|Median
2798291|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 3-month Follow up||3-months post randomization||||participants|||Number
2798292|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 9-month Follow up||9 months post randomization||||participants|||Number
2798293|NCT00534404|Primary|Self-reported 6-month Prolonged Abstinence From Smoking|Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.|Measured at 9 Months post-randomization|All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.|||participants|||Number
2798344|NCT00534235|Other Pre-specified|Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant|This is the mean change in foraminal height via x-ray from immediate post-op at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798294|NCT00534365|Secondary|Incontinence Severity Index Score|The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).|12 months||||units on a scale||Standard Deviation|Mean
2798295|NCT00534365|Secondary|Patient Global Impression Improvement||12 months|Please note that no all participants conducted the global improvement scale survey due to loss to follow up.|||Participants|||Count of Participants
2798296|NCT00534365|Secondary|Long Term Complications > 6 Weeks||6 weeks-12 months||||participants|||Number
2798297|NCT00534365|Secondary|Post Operative Complications at 6 Week or Less||6 week||||participants|||Number
2798298|NCT00534365|Primary|Subjective Cure of Urinary Incontinence at 12 Months After Surgery|Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.|12 months|Analysis based on per protocol enrollment|||Participants|||Count of Participants
2798299|NCT00534352|Secondary|CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)||Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)|||Percent Change from Baseline||Full Range|Median
2798300|NCT00534352|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)|CD4+ Cell Count (x 10^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 ans Week 48||||x 10^6 cell/L||Full Range|Median
2798301|NCT00534352|Secondary|Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)|Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)|||copies/mL||Standard Error|Mean
2798302|NCT00534352|Secondary|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case).|Day 8, 14, 22, 28, 42 and Week 48|ITT|||participants|||Number
2798303|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 48 and Week 48|ITT|||participants|||Number
2798304|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
2798305|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL).~Normal Range:~40 - 59 mG/dL 1.03 - 1.53 mmol/L"|Day 1 through 42 and Week 48|ITT|||participants|||Number
2798306|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
2798307|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin.~Normal Range: 3.0 - 27.0 ulU/mL"|Day 1 through 42 and Week 48||||participant|||Number
2798308|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia.~Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
2798309|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia|"Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia.~Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death."|Day 1 through 42 and Week 48|ITT|||participants|||Number
2798310|NCT00534352|Primary|Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av|At visit Days 14 & 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.|6 weeks|Intention To Treat (ITT) population|||participants|||Number
2798311|NCT00534313|Secondary|Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169|The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication at any time. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
2798321|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis|Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n = number of participants with evaluable results (each arm respectively).|||Participants|||Number
2798312|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized participants who received treatment and with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.|||Units on a scale||Standard Error|Mean
2798313|NCT00534313|Secondary|Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters|PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.|Days 1, 15, 29, 57, 85, 113, 141, and 169|||||||
2798314|NCT00534313|Secondary|Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept|Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.|||µg/mL||Full Range|Geometric Mean
2798315|NCT00534313|Secondary|Short-term Period: Mean Serum Concentrations of Abatacept|Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.|||µg/mL||Standard Deviation|Mean
2798316|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized and treated participants with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.|||Units on a scale||Standard Error|Mean
2798317|NCT00534313|Secondary|Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)|Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].|From Baseline to Day 169|Participants who received abatacept and for whom baseline and at least 1 additional measurement were available during the double-blind (short-term) period.|||Participants|||Number
2798318|NCT00534313|Secondary|Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169|Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study drug in double-blind (short-term) period. Only participants with both baseline and postbaseline values included. Missing values at Day 169 were imputed using the last observation carried forward values, except for participants with only baseline value.|||Percentage of change||Standard Error|Mean
2798319|NCT00534313|Secondary|Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169|Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
2798320|NCT00534313|Secondary|Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period.|||Participants|||Number
2798343|NCT00534235|Other Pre-specified|Bony Bridging|Bridging through the posterolateral gutters, between the facet joints, between transverse processes, and/or between facet joint and transverse process will all be considered acceptable forms of bridging bone.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||Levels|Levels||Count of Units
2798322|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results.|||Participants|||Number
2798323|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
2798324|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry|ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
2798325|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
2798326|NCT00534313|Primary|Short-term Period: Number of Participants With ACR 20 Response at Day 169|An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in the double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
2798327|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).|||Participants|||Number
2798328|NCT00534313|Secondary|Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729|Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.|Days 365 and 729 from baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with responses available)|||Participants|||Number
2798329|NCT00534313|Secondary|Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729|PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Days 365 and 729 from baseline||||Units on a scale||Standard Error|Mean
2798330|NCT00534313|Secondary|Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729|Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|From Baseline to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period.|||Percentage of change||Standard Deviation|Mean
2798869|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of FEV1 over FVC||Standard Error|Mean
2798331|NCT00534313|Secondary|Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729|IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|From Day 169 to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)|||Participants|||Number
2798332|NCT00534313|Secondary|Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729|An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.|At Days 365 and 729 from Baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)|||Percentage of participants||95% Confidence Interval|Number
2798333|NCT00534313|Primary|Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest|Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.|From Day 169 to Day 729|All participants who received at least 1 infusion of abatacept during the long-term period.|||Participants|||Number
2798334|NCT00534248|Secondary|Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing~hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Through 42 days post-vaccination|All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.|||participants|||Number
2798335|NCT00534248|Secondary|Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group|VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.|6 Weeks|Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded.|||gpELISA units/mL||95% Confidence Interval|Mean
2798336|NCT00534248|Primary|Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group|Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.|2 Years|Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned.|||number of HZ cases/1000 person-years||95% Confidence Interval|Mean
2798337|NCT00534235|Other Pre-specified|Device Mobility|Per level; Assessment is applicable to coflex arm only. Device Mobility is an expected occurrence in some subjects and represents the amount of the of lift-off of the implant from the inferior spinous process.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||Levels|Levels||Count of Units
2798338|NCT00534235|Other Pre-specified|Device Condition (Fusion Control)|Per level; This assessment is applicable to the fusion arm only. Device Condition in the control subjects will be graded as: Intact, Loose Screws, or Failed Hardware.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||Levels|Levels||Count of Units
2798339|NCT00534235|Other Pre-specified|Device Condition (Coflex Arm)|Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||Levels|Levels||Count of Units
2798340|NCT00534235|Other Pre-specified|Interface Remodeling - At Level(s) of Implant|Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||Levels|Levels||Count of Units
2798341|NCT00534235|Other Pre-specified|Fusion Status|The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||Levels|Levels||Count of Units
2798342|NCT00534235|Other Pre-specified|Heterotopic Ossification|Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||participants|Levels||Number
2798345|NCT00534235|Other Pre-specified|Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant|This is the mean change in foraminal height via x-ray from baseline at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798346|NCT00534235|Other Pre-specified|Foraminal Height (X-ray) (mm) - At Level(s) of Implant|This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798347|NCT00534235|Other Pre-specified|Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis from immediate post-op at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798348|NCT00534235|Other Pre-specified|Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798349|NCT00534235|Other Pre-specified|Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant|As determined by independent radiographic lab, this is the measure of the percentage of spondylolisthesis at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||percent|Levels|Standard Deviation|Mean
2798350|NCT00534235|Other Pre-specified|Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798351|NCT00534235|Other Pre-specified|Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant|As determined by independent radiographic lab, this is the mean change in disc angle from immediate post-op at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||degrees|Levels|Standard Deviation|Mean
2798352|NCT00534235|Other Pre-specified|Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant|As determined by independent radiographic lab, this is the mean change in disc angle from baseline at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||degrees|Levels|Standard Deviation|Mean
2798353|NCT00534235|Other Pre-specified|Disc Angle in Degrees - At Level(s) of Implant|As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||degrees|Levels|Standard Deviation|Mean
2798354|NCT00534235|Other Pre-specified|Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average change from immediate post-op for disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798355|NCT00534235|Other Pre-specified|Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average change from immediate post-op for posterior disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798356|NCT00534235|Other Pre-specified|Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average change from immediate post-op for anterior disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798357|NCT00534235|Other Pre-specified|Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average change from baseline for disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798358|NCT00534235|Other Pre-specified|Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average change from baseline for posterior disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798359|NCT00534235|Other Pre-specified|Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average change from baseline for anterior disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798380|NCT00534235|Secondary|Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm|Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.|5 years||||Participants|||Count of Participants
2798360|NCT00534235|Other Pre-specified|Average Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average measure of disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798361|NCT00534235|Other Pre-specified|Translation (F to E) in Percent (%) - Above Level of Implant|As determined by independent radiographic lab, this is the percentage of translation at the level above the implant in both treatment groups at 5 years.|5 years|This analysis was performed at the level above the 1- or 2-level device construct in both groups.|||percent||Standard Deviation|Mean
2798362|NCT00534235|Other Pre-specified|Translation (F to E) in Percent (%) - Below Level of Implant|As determined by independent radiographic lab, this is the percentage of translation at the level below the implant in both treatment groups at 5 years.|5 years|This analysis was performed at the level below the 1- or 2-level device construct in both groups.|||percent||Standard Deviation|Mean
2798363|NCT00534235|Other Pre-specified|Translation (F to E) in Percent (%) - At Level(s) of Implant|As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||percent|Levels|Standard Deviation|Mean
2798364|NCT00534235|Other Pre-specified|Posterior Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average measure of posterior disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798365|NCT00534235|Other Pre-specified|Anterior Disc Height (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average measure of anterior disc height at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798366|NCT00534235|Other Pre-specified|Translation (mm) - Above Level of Implant|As determined by independent radiographic lab, this is the average measure of translation at the level above the implant in both treatment groups at 5 years.|5 years|This analysis was performed at the level above the 1- or 2-level device construct in both groups.|||mm||Standard Deviation|Mean
2798367|NCT00534235|Other Pre-specified|Translation (mm) - Below Level of Implant|As determined by independent radiographic lab, this is the average measure of translation at the level below the implant in both treatment groups at 5 years.|5 years|This analysis was performed at the level below the 1- or 2-level device construct in both groups.|||mm||Standard Deviation|Mean
2798368|NCT00534235|Other Pre-specified|Translation (mm) - At Level(s) of Implant|As determined by independent radiographic lab, this is the average measure of translation at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||mm|Levels|Standard Deviation|Mean
2798369|NCT00534235|Other Pre-specified|Rotation (F to E) in Degrees - Above Level of Implant|As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level above the implant in both treatment groups at 5 years.|5 years|This analysis was performed at the level above the 1- or 2-level device construct in both groups.|||degrees||Standard Deviation|Mean
2798370|NCT00534235|Other Pre-specified|Rotation (F to E) in Degrees - Below Level of Implant|As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level below the implant in both treatment groups at 5 years.|5 years|This analysis was performed at the level below the 1- or 2-level device construct in both groups.|||degrees||Standard Deviation|Mean
2798371|NCT00534235|Other Pre-specified|Mean Rotation (F to E) in Degrees - At Level(s) of Implant|As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the index level(s) in both treatment groups at 5 years.|5 years|This analysis was performed at each level implanted. Since there were subjects with 2 levels implanted, the number of levels is greater than the number of patients.|||degrees|Levels|Standard Deviation|Mean
2798372|NCT00534235|Secondary|Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group|Number of subjects using NSAIDs/ASA/Acetaminophen|5 years||||Participants|||Count of Participants
2798373|NCT00534235|Secondary|Pain Management: Class II Narcotics Usage by Device Group|Number of subjects using Class II narcotics|5 years||||Participants|||Count of Participants
2798374|NCT00534235|Secondary|Patient Survey: Recommendation of Treatment|"Subjects who responded Definitely Yes or Probably Yes"|5 years||||Participants|||Count of Participants
2798375|NCT00534235|Secondary|Patient Survey: Satisfaction|"Subjects who responded Very Satisfied or Somewhat Satisfied."|5 years||||Participants|||Count of Participants
2798376|NCT00534235|Secondary|Mean Short Form-12 Mental Component Score|Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.|5 years||||units on a scale||Standard Deviation|Mean
2798377|NCT00534235|Secondary|Mean Short Form-12 Physical Component Score|Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.|5 years||||units on a scale||Standard Deviation|Mean
2798378|NCT00534235|Secondary|Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score|Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.|5 years||||units on a scale||Standard Deviation|Mean
2798379|NCT00534235|Secondary|Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score|Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.|5 years||||units on a scale||Standard Deviation|Mean
2798388|NCT00534235|Secondary|Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm|Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.|5 years||||Participants|||Count of Participants
2798389|NCT00534235|Secondary|Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component|Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.|5 years||||Participants|||Count of Participants
2798390|NCT00534235|Secondary|Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component|Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.|5 years||||Participants|||Count of Participants
2798391|NCT00534235|Secondary|Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points|ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.|5 years||||Participants|||Count of Participants
2798392|NCT00534235|Secondary|Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points|ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.|5 years||||Participants|||Count of Participants
2798393|NCT00534235|Primary|Number of Subjects With no Reoperations or Epidural (Up to Day 1825)|No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.|5 years||||Participants|||Count of Participants
2798394|NCT00534235|Primary|Number of Subjects With no Persistent New or Increasing Motor Deficit|No persistent new or increasing motor deficit|5 years||||Participants|||Count of Participants
2798395|NCT00534235|Primary|Number of Subjects With no Persistent New or Increasing Sensory Deficit|No persistent new or increasing sensory deficit|5 years||||Participants|||Count of Participants
2798396|NCT00534235|Primary|Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit|No persistent new or increasing sensory or motor deficit|5 years||||Participants|||Count of Participants
2798397|NCT00534235|Primary|Number of Subjects With no Epidural Injection(s)|Assessment of lumbar epidural injections|5 years||||Participants|||Count of Participants
2798398|NCT00534235|Primary|Number of Subjects With no Major Device Related Complications|Assessment of major device-related complications at 5 years|5 years||||Participants|||Count of Participants
2798399|NCT00534235|Primary|Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation|Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).|5 years||||Participants|||Count of Participants
2798400|NCT00534235|Primary|Number of Subjects With Improvement of at Least 15 Points in ODI|The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group (scale 0-100 with a higher score representing increased disability).|5 years|The accounting #s in the Patient Flow include all subjects available for CCS evaluation; therefore, the overall # of participants analyzed for each Outcome Measure will differ from the number provided in the Participant Flow as the number provided for each Outcome Measure is the number of patients who completed or were assessed for that measure.|||Participants|||Count of Participants
2798401|NCT00534209|Secondary|Correlative Immunological Studies in Study Participants (Phase 2)|The time course of patients' adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-γ), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13).|Baseline, Week 7 and Week 13|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798402|NCT00534209|Secondary|Overall Survival (Phase 2)|The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive.|Date of randomization to the recorded date of death|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798403|NCT00534209|Secondary|Response to Second-line Chemotherapy After Disease Progression (Phase 2)|The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.|From Week 1 of Study Therapy until Death or Withdrawal of Consent|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798404|NCT00534209|Secondary|Safety Profile (Phase 2)|The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|About 13 weeks|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798405|NCT00534209|Secondary|Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)|Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).|From Week 1 of Study Therapy until Death or Withdrawal of Consent|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798406|NCT00534209|Secondary|Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)|Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.|About 13 weeks|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798407|NCT00534209|Primary|Progression-free Survival (Phase 2)||Date of randomization to the earliest date of documented progression.|This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.||||||
2798408|NCT00534209|Primary|Preliminary Safety Profile (Phase 1)|This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|Up to 13 weeks||||participants|||Number
2798409|NCT00534105|Secondary|LDL|LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum||||mg/dl||Inter-Quartile Range|Mean
2798410|NCT00534105|Secondary|HDL|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum||||mg/dl||Inter-Quartile Range|Mean
2798411|NCT00534105|Secondary|Triglyceride Values|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum||||mg/dl||Inter-Quartile Range|Mean
2798412|NCT00534105|Primary|Cholesterol|Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls|Postpartum||||mg/dl||Inter-Quartile Range|Mean
2798413|NCT00534092|Other Pre-specified|Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study||3+ years following first 2 years post-X-STOP implant through IDE study||||participants|||Number
2798414|NCT00534092|Other Pre-specified|Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study|The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.|3+ years following first 2 years post-X-STOP implant through IDE study||||participants|||Number
2798415|NCT00534092|Secondary|Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)|"Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 worst to 100 best. The change from baseline to the 5 year postoperative visit for each of these domains is presented."|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study||||units on a scale||Standard Deviation|Mean
2798416|NCT00534092|Secondary|Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.|3+ years following first 2 years post-X-STOP implant through IDE study||||units on a scale||Standard Deviation|Mean
2798417|NCT00534092|Secondary|Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study||||units on a scale||Standard Deviation|Mean
2798418|NCT00534092|Primary|Treatment Success Rates (At ≥ 5 Years)|Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.|3+ years following first 2 years post-X-STOP implant through IDE study|Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.|||percentage of participants|||Number
2798419|NCT00534001|Secondary|Abstinence|Bioverified 4-week continuous abstinence|4 weeks||||Participants|||Count of Participants
2798420|NCT00534001|Primary|Prequit Change in Cigarettes Per Day|Prequit Change in Cigarettes Per Day|3-Week PreQuit Drug Manipulation Phase|Excludes participants with missing data (2 in Arm 1, 3 in Arm 2)|||Cigarettes Per Day||Standard Error|Mean
2798427|NCT00533949|Secondary|Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).|A decline of 2 points in the LCS from baseline to 3 months was considered a clinically meaningful change indicating a decline in quality of life. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|At baseline and 3 months.|Eligible patients who enrolled while the high dose arms were open, had baseline and 3 month assessments, and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2798421|NCT00533949|Secondary|Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure|Standardized uptake value (SUV) is a simple way of determining activity in PET imaging. It is a mathematically derived ratio of tissue radioactivity concentration at a point in time and the injected dose of radioactivity per kilogram of the patient's body weight. All event times are time from randomization to date of event or censoring. A survival event is death from any cause, patients without events are censored at the date of last contact, and survival rates are estimated by Kaplan-Meier method. Local-regional and distant metastasis events are the first development of progressive disease locally/regionally or distant metastasis, respectively, patients who do not have an event are censored at the date of death or last contact, and event rates are estimated by cumulative incidence. Two-year rates are presented. PET SUV was evaluated as a continuous variable therefore the outcome variables are not summarized by PET SUV.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|Eligible patients with PET SUV data at baseline.|||percentage of participants||95% Confidence Interval|Number
2798422|NCT00533949|Secondary|Prognostic and Predictive Effects of Gross Tumor Volume (GTV) on Overall Survival|"Gross tumor volume (GTV) is defined as the combined volume (cubic centimeters) of the primary tumor and clinically positive lymph nodes seen either on the planning computed tomography (CT) scan or the pretreatment positron emission tomography (PET) scan. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. GTV was evaluated as a continuous variable therefore overall survival time is not summarized by GTV. Prognostic refers to the main effect and predictive refers to the interaction between GTV and treatment arm."|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|Eligible patients with GTV data|||months||95% Confidence Interval|Median
2798423|NCT00533949|Secondary|Percentage of Patients With Grade 3+ Adverse Events by Epithelial Growth Factor Receptor (EGFR) Group|EGFR is a protein that is present on the surface of both normal cells and cancer cancer cells. EGFR H-Score is a measure of staining intensity ranging from 0 to 300 where a higher value indicates greater intensity of EGFR. Available tumor samples were evaluated for EGFR and given an H-Score. Patients were divided into two groups based on H-Score values dichotomized at 200. Worst toxicity as determined by adverse events was used as a measure of a patient's quality of life (QOL). Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Highest grade (worst) adverse event (AE) per subject was counted.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|Eligible patients with EGFR H-Score|||percentage of participants||95% Confidence Interval|Number
2798424|NCT00533949|Secondary|Overall Survival and Local-regional Failure by Epithelial Growth Factor Receptor (EGFR) Group|EGFR is a protein that is present on the surface of both normal cells and cancer cancer cells. EGFR H-Score is a measure of staining intensity ranging from 0 to 300 where a higher value indicates greater intensity of EGFR. Available tumor samples were evaluated for EGFR and given an H-Score. Patients were divided into two groups based on H-Score values dichotomized at 200. All event times are time from randomization to date of event or censoring. A survival event is death from any cause, patients without events are censored at the date of last contact, and survival rates are estimated by Kaplan-Meier method. A local-regional event is the first development of progressive disease locally or regionally, patients who do not have an event are censored at the date of death or last contact, and event rates are estimated by cumulative incidence. Two-year rates are reported.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|Eligible patients with EGFR H-Score|||percentage of participants||95% Confidence Interval|Number
2798425|NCT00533949|Secondary|EuroQoL (EQ5D) Visual Analog Scale (VAS) Through One Year (Area Under the Curve)|The visual analogue scale is a self-assessment of current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The area under the curve of each subject's EQ5D visual analog scale (VAS) response trajectory within 1 year was calculated. The EQ5D VAS utility was normalized by the baseline score. The trajectory included all available time points through one year. If a subject died within one year, the EQ5D VAS was reduced to 0 at the time of death. If subject was censored within one year, the EQ5D utility curve was truncated at the time of censoring. The scores were plotted across time and the area under the curve was calculated. A greater area under the curve indicates a better health state. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation|From randomization to one year|Eligible patients enrolled while the high radiation therapy dose arms were open to accrual, started treatment, and had baseline and at least one follow-up EQ5D VAS.|||Score on a scale * months||Inter-Quartile Range|Median
2798426|NCT00533949|Secondary|Patient-reported Swallowing Score (Area Under the Curve)|Patients completed a swallowing diary prior to the start of treatment and then daily during treatment. Patients recorded a score to indicate problems with swallowing on that day (1-None, 2-Mild soreness only, 3-Can swallow solids with some difficulty, 4-Cannot swallow solids, 5-Cannot swallow liquids). These scores were then plotted across time and the area under the curve from baseline until the end of week 6 was calculated. A lower area under the curve indicates better swallowing ability. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|From randomization to 6 weeks after start of radiation therapy (6-10 weeks from randomization)|Eligible patients enrolled while the high radiation therapy dose arms were open to accrual and who had at least 15 diary entries including one prior to start of radiation therapy and one during sixth week from start of radiation therapy.|||Area under curve (score * days)||Inter-Quartile Range|Median
2798672|NCT00531934|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||days||95% Confidence Interval|Median
2798428|NCT00533949|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment|Deaths regardless of cause and occuring during or within 30 days of discontinuation of protocol treatment were evaluated.|From start of protocol treatment to 24 months.|Eligible patients who started study treatment and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2798429|NCT00533949|Secondary|Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0|Treatment-related adverse events other than esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2798430|NCT00533949|Secondary|Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0|Treatment-related esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2798431|NCT00533949|Secondary|Local-regional Failure (Reported as Two-year Estimates)|A failure for local-regional failure is the first occurrence of local or regional progression. Time is measured from the date of randomization to the date of first failure. Patients alive without local or regional failure at the time of last follow-up are censored. Patients who died without local or regional failure are considered as having competing risk at the time of death. Local-regional failure was estimated by the cumulative incidence method and 2 year estimates are reported.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison.|||percentage of participants||95% Confidence Interval|Number
2798432|NCT00533949|Secondary|Progression-free Survival|A failure for progression-free survival (PFS) is the first occurrence of local or regional progression, distant metastases, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Time is measured from the date of randomization to the date of first failure. Patients without failure are censored at the date of last follow-up.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison.|||months||95% Confidence Interval|Median
2798433|NCT00533949|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.|"Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison. See Limitations and Caveats."|||months||95% Confidence Interval|Median
2798434|NCT00533897|Secondary|LTE: Mean Temperature (T) During LTE|During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||degrees Celsius||Standard Deviation|Mean
2798435|NCT00533897|Secondary|LTE: Mean Heart Rate (HR) During LTE|During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||bpm||Standard Deviation|Mean
2798436|NCT00533897|Secondary|LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mmHg||Standard Deviation|Mean
2798437|NCT00533897|Secondary|LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mm Hg||Standard Deviation|Mean
2798438|NCT00533897|Secondary|LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the LTE period.|||participants|||Number
2798439|NCT00533897|Secondary|LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.|||participants|||Number
2798440|NCT00533897|Secondary|LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.|||participants|||Number
2798441|NCT00533897|Secondary|LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.|||participants|||Number
2798442|NCT00533897|Secondary|LTE: Number of Participants With AEs of Special Interest During LTE|AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period|||participants|||Number
2798443|NCT00533897|Secondary|LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred > 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period|||participants|||Number
2798444|NCT00533897|Secondary|LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989.|Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE|All participants treated in LTE period with at least 1 immunogenicity result (ECL) during LTE period. n=number of participants evaluated.|||percentage of participants|||Number
2798445|NCT00533897|Secondary|LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days.|Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were non-responders at the end of Period 1. n= number of participants with data who were evaluated|||percentage of participants||95% Confidence Interval|Number
2798446|NCT00533897|Secondary|LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE|DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1.|||percentage of participants|||Number
2798447|NCT00533897|Secondary|LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169.|For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n= number of participants evaluated at each specific timepoint|||percentage of participants|||Number
2798448|NCT00533897|Secondary|LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n=number of participants with both baseline and post-baseline measurements.|||units on a scale||Standard Error|Mean
2798449|NCT00533897|Secondary|ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups|Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253.|Baseline, Day 253|Participants treated in DBW period with at least 1 immunogenicity result (immunofluorescence, radioimmunoassay, or immunoturbidimetry) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||participants|||Number
2798450|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL.|Day 197 through Day 253|Participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||ug/mL||Standard Deviation|Mean
2798870|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798451|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA.|Day 197 through Day 253|Participants treated during the RI Period with at least 1 immunogenicity result (ELISA) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||ug/mL||Standard Deviation|Mean
2798452|NCT00533897|Secondary|RI Period; Mean Temperature (T) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||degrees Celsius||Standard Deviation|Mean
2798453|NCT00533897|Secondary|RI Period; Mean Heart Rate (HR) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||beats per minute (bpm)||Standard Deviation|Mean
2798454|NCT00533897|Secondary|RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mm mercury (Hg)||Standard Deviation|Mean
2798455|NCT00533897|Secondary|RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
2798456|NCT00533897|Secondary|RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
2798457|NCT00533897|Secondary|RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
2798458|NCT00533897|Secondary|RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.|||participants|||Number
2798459|NCT00533897|Secondary|RI; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.|||participants|||Number
2798501|NCT00533845|Primary|Visual Aanalog Scale (VAS) for Pain Assessment With Cough at 48 Hours|Pain assessment using a subjective pain visual analog scale VAS with cough at 48 hours. Participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).|48 hours postop||||units on a scale||Standard Deviation|Mean
2798502|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 14|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 14 (21-day cycle)|Zero participants were analyzed.||||||
2798503|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 7|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 7 (21-day cycle)|Zero participants were analyzed.||||||
2798460|NCT00533897|Secondary|RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.|||participants|||Number
2798461|NCT00533897|Secondary|DBW Period; Mean Temperature (T) During Period II|Participants were seated and temperature taken just prior to study drug injection.|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||degrees Celsius||Standard Deviation|Mean
2798462|NCT00533897|Secondary|DBW Period; Mean Heart Rate (HR) During Period 2|Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm)|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||beats per minute (bpm)||Standard Deviation|Mean
2798463|NCT00533897|Secondary|DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period|Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg).|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.|||mm mercury (Hg)||Standard Deviation|Mean
2798464|NCT00533897|Secondary|DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
2798465|NCT00533897|Secondary|DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
2798466|NCT00533897|Secondary|DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
2798467|NCT00533897|Secondary|DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.|||participants|||Number
2798468|NCT00533897|Secondary|DBW; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period|||participants|||Number
2798504|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 1|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 1 (21-day cycle) 1-hour post infusion|Zero participants were analyzed.||||||
2798469|NCT00533897|Secondary|DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period|||participants|||Number
2798470|NCT00533897|Secondary|LI Period; Mean Temperature (T)|Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.|||degrees Celsius||Standard Deviation|Mean
2798471|NCT00533897|Secondary|LI Period; Mean Heart Rate (HR)|Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.|||bpm||Standard Deviation|Mean
2798472|NCT00533897|Secondary|LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.|||mmHg||Standard Deviation|Mean
2798473|NCT00533897|Secondary|LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*upper limits of normal (ULN),or if BL< lower limits of normal (LLN) then use 0.8*BL or > upper limits of normal (ULN),or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >ULN,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during LI period.|||participants|||Number
2798474|NCT00533897|Secondary|LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.|||participants|||Number
2798475|NCT00533897|Secondary|LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.|||participants|||Number
2798476|NCT00533897|Secondary|LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/ microliter (uL); eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.|||participants|||Number
2798524|NCT00533507|Secondary|Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798477|NCT00533897|Secondary|LI Period; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period|||participants|||Number
2798478|NCT00533897|Secondary|LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period|||participants|||Number
2798479|NCT00533897|Secondary|RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 169 (Period III Baseline), 197, 225, and 253|Participants who received at least 1 dose of study medication during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at RI period baseline.|||units on a scale||Standard Error|Mean
2798480|NCT00533897|Secondary|DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time|"A participant had an RA flare if at least 2 of the following criteria were met:~Doubling of tender and swollen joint count from Day 78~Increase in DAS28-CRP score ≥ 1.2 from Day 78~Prematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)"|Days 85, 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
2798481|NCT00533897|Secondary|DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85 (Period 2 Baseline), 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at DBW period baseline.|||units on a scale||Standard Error|Mean
2798482|NCT00533897|Secondary|LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||percentage of participants|||Number
2798483|NCT00533897|Secondary|LI; Mean Change in DAS 28 (CRP) From Baseline Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline), 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||units on a scale||Standard Error|Mean
2798484|NCT00533897|Secondary|Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||percentage of Participants|||Number
2798525|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798485|NCT00533897|Secondary|Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||units on a scale||Standard Error|Mean
2798486|NCT00533897|Secondary|Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85, 169, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and, when relevant, at baseline.|||percentage of participants|||Number
2798487|NCT00533897|Secondary|Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups|The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.|||units on a scale||Standard Error|Mean
2798488|NCT00533897|Secondary|Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of Participants|||Number
2798489|NCT00533897|Secondary|Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups|Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253).|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
2798490|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
2798491|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
2798871|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798492|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits||||||
2798493|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
2798494|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits.||||||
2798495|NCT00533897|Primary|Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
2798496|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point.|||percentage of participants|||Number
2798497|NCT00533897|Secondary|LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in Period 1 (Lead-in Period). N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
2798498|NCT00533897|Secondary|Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in LI Period who had at least 1 immunogenicity result (ELISA) during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
2798499|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated with Placebo in DBW period who were treated in RI period and had at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
2798500|NCT00533897|Primary|Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 169|Participants treated in the DBW Period with at least 1 immunogenicity result (ELISA) during DBW Period. N=Number of Participants Analyzed, n=number of participants with data for that time point|||percentage of participants|||Number
2798872|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798505|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks|Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants|||Number
2798506|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants|||Number
2798507|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|6 weeks (2 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants|||Number
2798508|NCT00533702|Secondary|Duration of Response|The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug and who had CR or PR. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=2; IMC-1121B (ramucirumab)=0.|||months||95% Confidence Interval|Median
2798509|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
2798510|NCT00533702|Secondary|Number of Participants With Adverse Events (AE)|The number of participants who experienced any IMC-1121B (ramucirumab [RAM]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 40 months|Safety Population: All enrolled participants who were treated with any quantity of study drug.|||participants|||Number
2798511|NCT00533702|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.|Baseline up to 36 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=9; IMC-1121B (ramucirumab)=4.|||months||95% Confidence Interval|Median
2798526|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798527|NCT00533507|Secondary|Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798512|NCT00533546|Secondary|National Institutes of Health Stroke Scale (NIHSS)|"The NIHSS is a measure of neurologic deficit on a scale of 0-42, with 0 being normal. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. The 11 items are:~Level of Consciousness Horizontal Eye Movement Visual field test Facial Palsy Motor Arm Motor Leg Limb Ataxia Sensory Language Speech Extinction and Inattention"|90 days||||units on a scale||Standard Deviation|Mean
2798513|NCT00533546|Secondary|Mean Barthel Index Score|"Measure of functional recovery using Barthel Index (range 0-100). The Barthel scale or Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility with 10 points given to each variable for a total of 100 points. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The ten variables addressed in the Barthel scale are:~presence or absence of fecal incontinence presence or absence of urinary incontinence help needed with grooming help needed with toilet use help needed with feeding help needed with transfers (e.g. from chair to bed) help needed with walking help needed with dressing help needed with climbing stairs and help needed with bathing"|90 days||||units on a scale||Standard Deviation|Mean
2798514|NCT00533546|Secondary|Mean Modified Rankin Scale Score|"Measure of disability as determined by categorical assignment on modified Rankin Scale.. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.~The scale runs from 0-6, running from perfect health without symptoms to death.~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|90 days||||units on a scale||Standard Deviation|Mean
2798515|NCT00533546|Primary|Number of Participants With Intracranial Hemorrhage|"Intracranial Hemorrhage (ICH):~Fatal ICH: Death ascribed to ICH confirmed by autopsy or CT imaging. Major non-fatal ICH: Hemorrhage within brain parenchyma associated with neurological deterioration or evidence of subdural, epidural or intraventricular hemorrhage on CT imaging, with or without symptoms.~Symptomatic ICH: Hemorrhage within the territory of qualifying infarction with neurological deterioration as measured by > 2 point increase in the National Institutes of Health Stroke Scale (NIHSS) from previous examination; hemorrhage in different vascular territory associated with new neurologic deficit. All symptomatic ICH will be defined as a major ICH.~Asymptomatic ICH: Presence of hemorrhage within the territory of qualifying infarction without neurological deterioration ascribed to the hemorrhage or presence of hemorrhage within brain parenchyma outside the territory of qualifying infarction without new neurologic deficit (would not be considered a major ICH)"|Measured within 36-48 hours of treatment|All participants enrolled were analyzed.|||participants|||Number
2798516|NCT00533507|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to one month after the third dose||||subjects|||Number
2798517|NCT00533507|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 31-day (Day 0-30) period after each dose||||subjects|||Number
2798518|NCT00533507|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting|During the 4-day (Day 0-3) period after each dose||||subjects|||Number
2798519|NCT00533507|Secondary|Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value|Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).|Four months after the administration of the second dose of Rotarix™ vaccine|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798520|NCT00533507|Secondary|Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value|Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798521|NCT00533507|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798522|NCT00533507|Secondary|Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value|Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798523|NCT00533507|Secondary|Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value|Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798528|NCT00533507|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798529|NCT00533507|Secondary|Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value|Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2798530|NCT00533507|Primary|Concentration of Anti-Pneumococcal Antibodies|"Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||µg/mL||95% Confidence Interval|Geometric Mean
2798531|NCT00533507|Primary|Concentration of Anti-Protein D Antibodies|Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
2798532|NCT00533442|Secondary|Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.|Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.|at 1-5 years post-transplant|Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time|||ng/mL||Standard Error|Mean
2798533|NCT00533442|Secondary|Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.|Comparisons of renal function (eGFR, measured in mL/min/1.73 m^2) at 12, 36, and 60 months post-transplant.|at 1-5 years post-transplant|Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time|||mL/min/1.73m^2||Standard Error|Mean
2798534|NCT00533442|Primary|Event-Specific Survival Comparisons|Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.|over 1-10 years post-transplant||||Participants|||Count of Participants
2798535|NCT00533351|Primary|Change From Baseline in Daily Pain Score at Week 2|Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed||||||
2798536|NCT00533351|Secondary|Change From Baseline in Subject Global Impression of Change Score at Week 2|Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed.||||||
2798537|NCT00533273|Secondary|Change From Baseline Range of Motion in Non-Primary Joint After the First Injection|Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion prior to the next injection − baseline range of motion|Baseline, Day 30 after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Degrees|Joints|Standard Deviation|Mean
2798538|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Non-Primary Joint After the First Injection|Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture − last available post-injection contracture prior to next injection)/baseline contracture|Baseline, Day 30 after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of change|Joints|Standard Deviation|Mean
2798539|NCT00533273|Secondary|Clinical Improvement in Non-Primary Joint After the First Injection|Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
2798540|NCT00533273|Secondary|Clinical Success in Non-Primary Joint After the First Injection|Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after first injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
2798541|NCT00533273|Secondary|Time to Reach Clinical Success in Non-Primary Joint|Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories|Within 30 days after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
2798841|NCT00530920|Secondary|Maximum Concentration (Cmax) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
2798542|NCT00533273|Secondary|Change From Baseline Range of Motion in Non-Primary Joint After the Last Injection|Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Degrees|Joints|Standard Deviation|Mean
2798543|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Non-Primary Joint After the Last Injection|Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture|Baseline, Day 30 after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of change|Joints|Standard Deviation|Mean
2798544|NCT00533273|Secondary|Clinical Improvement in Non-Primary Joint After the Last Injection|Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
2798545|NCT00533273|Secondary|Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection|Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after last injection|Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period|||Percentage of Joints|Joints||Number
2798546|NCT00533273|Secondary|Change From Baseline Range of Motion in Primary Joint After the First Injection|Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection − baseline range of motion|Baseline, Day 30 after first injection|Subjects who were randomized and received at least 1 injection|||Degrees|Joints|Standard Deviation|Mean
2798547|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Primary Joint After the First Injection|Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture − last available post-injection contracture prior to next injection)/baseline contracture|Baseline, Day 30 after first injection|Subjects who were randomized and received at least 1 injection|||Percentage of change|Joints|Standard Deviation|Mean
2798548|NCT00533273|Secondary|Clinical Improvement in Primary Joint After the First Injection|Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after first injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
2798549|NCT00533273|Secondary|Clinical Success in Primary Joint After the First Injection|Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after first injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
2798550|NCT00533273|Secondary|Time to Reach Clinical Success in Primary Joint|Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories|Within 30 days after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
2798551|NCT00533273|Secondary|Change From Baseline Range of Motion in Primary Joint After the Last Injection|Change in degree of range of motion in primary joint measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after last injection|Subjects who were randomized and received at least 1 injection|||Degrees|Joints|Standard Deviation|Mean
2798552|NCT00533273|Secondary|Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection|Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture|Baseline, Day 30 after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of change|Joints|Standard Deviation|Mean
2798553|NCT00533273|Secondary|Clinical Improvement in Primary Joint After the Last Injection|Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, Within 30 days after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
2798554|NCT00533273|Primary|Reduction in Primary Joint Contracture to 5° or Less|Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after last injection|Subjects who were randomized and received at least 1 injection|||Percentage of Joints|Joints||Number
2798555|NCT00533117|Primary|Suicide Attempts|Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)|Assessed bimonthly|Suicidal and/or self injuring individuals with borderline personality disorder.|||suicide attempt|||Number
2798556|NCT00532948|Secondary|Anti Tumor Activity|Tumor response refers to the best response prior to failure (disease progression, death or second malignancy).|Up to 6 years|Efficacy data of the present study (NO18517 - NCT00532948) were pre-specified to be combined with efficacy data of the Phase 2 portion of this Study, NO21125 (NCT01118377) for analysis. Results are currently posted in the record of Study NO21125.||||||
2798567|NCT00532935|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32|Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||mg/dL||95% Confidence Interval|Least Squares Mean
2798860|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Deviation|Mean
2798557|NCT00532948|Secondary|The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)|AUC last concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||h*ng/mL||Standard Deviation|Mean
2798558|NCT00532948|Secondary|Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)|Tmax is the corresponding time at which Cmax occurs of capecitabine and its metabolites.Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||Hour||Full Range|Median
2798559|NCT00532948|Secondary|Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])|The maximum observed plasma concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||ng/mL||Standard Deviation|Mean
2798560|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters|For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||Participants|||Number
2798561|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters|For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.|||Participants|||Number
2798562|NCT00532948|Primary|Number of Participants With Adverse Events (AE)|An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine.|||Participants|||Number
2798563|NCT00532948|Primary|Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs).|Upto 11 weeks|The safety population consisted of all eligible patients who received at least one dose of capecitabine.|||Participants|||Number
2798564|NCT00532948|Primary|Maximum Tolerated Dose (MTD) of Capecitabine.|The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Upto 11 weeks.|The safety population consisted of all eligible patients who received at least one dose of capecitabine.|||milligrams|||Number
2798565|NCT00532935|Secondary|Percent of Participants With A1C <7.0% at Week 32||Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||Percent Participants|||Number
2798566|NCT00532935|Secondary|Change From Baseline in FPG at Week 32|Change from baseline reflects the Week 32 FPG minus the baseline FPG|Baseline and Week 32|Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||mg/dL||95% Confidence Interval|Least Squares Mean
2798669|NCT00531934|Secondary|Overall Survival (OS) - Time to Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||days||95% Confidence Interval|Median
2798568|NCT00532935|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1|Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone|Baseline and Week 1|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome.|||mg/dL||95% Confidence Interval|Least Squares Mean
2798569|NCT00532935|Primary|Change From Baseline in A1C at Week 32|A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
2798570|NCT00532883|Primary|Distribution of the Density of Hemoglobin SC Red Cells|An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.|measured 2 months after initiation of treatment|ITT: All randomized subjects who receive any clinical trial material. Subjects in the ITT population will be classified according to the treatment group to which they were randomized, regardless of what study drug they received.|||percent of cells||Standard Deviation|Mean
2798571|NCT00532779|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2798572|NCT00532779|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2798573|NCT00532779|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2798574|NCT00532779|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
2798575|NCT00532779|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
2798576|NCT00532779|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2798577|NCT00532779|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2798578|NCT00532779|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2798579|NCT00532779|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2798580|NCT00532779|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2798581|NCT00532779|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2798861|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values|||Unit on a Scale||Standard Deviation|Mean
2798582|NCT00532779|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2798583|NCT00532779|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2798584|NCT00532779|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2798585|NCT00532779|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
2798586|NCT00532779|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2798587|NCT00532779|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2798588|NCT00532779|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
2798589|NCT00532493|Secondary|Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)|Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798590|NCT00532493|Secondary|Quality of Life Inventory (QOLI)|Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798591|NCT00532493|Secondary|SF-12 Mental Standardized Score (SF-12 MCS)|Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798592|NCT00532493|Secondary|SF-12 Physical Standardized Score (SF-12 PCS)|Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798593|NCT00532493|Secondary|Patient Health Questionnaire-9 (PHQ9)|Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798594|NCT00532493|Secondary|PTSD Checklist-Military Version (PCL-M) Score|Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.|This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798595|NCT00532493|Primary|Clinical Global Impression of Change (CGIC)|Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10|||scores on a scale||Standard Deviation|Mean
2798596|NCT00532493|Secondary|Total CAPS Score|Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.|The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798597|NCT00532493|Secondary|Clinical Global Impression of Change|Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798598|NCT00532493|Secondary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798599|NCT00532493|Secondary|Pittsburgh Sleep Quality Index|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks|||scores on a scale||Standard Deviation|Mean
2798600|NCT00532493|Primary|Pittsburgh Sleep Quality Index (PSQI)|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10|||scores on a scale||Standard Deviation|Mean
2798601|NCT00532493|Primary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10|||scores on a scale||Standard Deviation|Mean
2798602|NCT00532480|Primary|17-item Hamilton Depression Rating Scale|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|8 weeks|10 patients included in the study out of which 7 completed 8 weeks of the study|||units on a scale||Standard Deviation|Mean
2798603|NCT00532441|Secondary|Overall Survival|Determine Overall Survival|18 Months||||months||95% Confidence Interval|Median
2798604|NCT00532441|Secondary|Response Rate|Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)|18 months||||participants|||Number
2798605|NCT00532441|Primary|16 Weeks Progression-free Survival|To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|Start of treatment until disease progression per RECIST criteria up to 16 weeks||||months||95% Confidence Interval|Median
2798606|NCT00532298|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2798607|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2798608|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
2798609|NCT00532298|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2798873|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798610|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
2798611|NCT00532298|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2798612|NCT00532298|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Subjects|||Number
2798613|NCT00532298|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||Subjects|||Number
2798614|NCT00532298|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||fold increase||95% Confidence Interval|Geometric Mean
2798615|NCT00532298|Secondary|The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||Subjects|||Number
2798616|NCT00532298|Secondary|HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations|Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.|||titer||95% Confidence Interval|Geometric Mean
2798617|NCT00532298|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available. This primary outcome was assessed only on those groups receiving any of the GSK Bio's influenza vaccine GSK576389A formulations.|||titer||95% Confidence Interval|Geometric Mean
2798618|NCT00532259|Secondary|Overall Survival||within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).||||Percent||90% Confidence Interval|Number
2798619|NCT00532259|Primary|Progression-free Survival|PFS (progression-free survival ) will be determined at the eligible patient populations|16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).|Patients who did not meet key study entry criteria were excluded from the eligible data set.|||Percent||90% Confidence Interval|Number
2798620|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies, and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for ABSI.|||units on a scale||Standard Deviation|Mean
2798621|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for LCSS.|||units on a scale||Standard Deviation|Mean
2798622|NCT00532155|Secondary|Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"Participants with OR were those who had a confirmed complete response [CR] or a confirmed partial response [PR], based on RECIST criteria, in which~CR refected the disappearance of all tumor lesions (with no new tumors)~PR reflected a pre-defined decrease in tumor burden - a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~OR was CR + PR The response rate was the percent of participants with a response.~To determine a response, tumors were assessed by the investigators using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks."|Baseline to data cut-off (26 January 2011)|Evaluable population: All ITT participants with measurable disease at study entry, and with at least one valid post baseline tumor evaluation, except if the participant died due to progressive disease or had documented (ie, radiological) progression before having any post-baseline tumor evaluation.|||percentage of participants|||Number
2798623|NCT00532155|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time interval between the date of randomization and the time of occurrence of the first radiological tumor progression detected by a computer tomography (CT) scan and /or by Magnetic Resonance Imaging (MRI); or death due to any cause; whichever was earlier. Participants without disease progression were censored at the earliest date between their last valid tumour assessment and the data cutoff date.~PFS was estimated from Kaplan-Meier Curves."|Baseline to data cut-off (26 January 2011)|Intent to treat (ITT) population. The results are based on a total of 865 PFS events (434 in the placebo group and 431 in the aflibercept group) at the time of cutoff.|||months|Participants|95% Confidence Interval|Median
2798624|NCT00532155|Primary|Overall Survival (OS)|"OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed.~OS was estimated from Kaplan-Meier Curves."|Baseline to the date when 687 deaths occurred (26 January 2011)|All randomized participants.|||months|Participants|95% Confidence Interval|Median
2798625|NCT00532129|Secondary|Mean Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores|EORTC QLQ-C30: included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|Baseline, Day 1 of Cycles 5 and 11, end of follow-up (FU) (24 month [m] FU visit, up to approximately 3 years)|FAS. Number of participants analyzed = number of participants evaluable for this outcome and n=number of participants evaluable at the specified time point.|||units on scale||Standard Deviation|Mean
2798626|NCT00532129|Secondary|Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity|MRD negativity was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a confirmed CR. CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.|||percentage of participants|||Number
2798627|NCT00532129|Secondary|Overall Survival (OS) Time|This was defined as the interval (number of days) from the trial treatment start date to the date of death by any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants||95% Confidence Interval|Median
2798628|NCT00532129|Secondary|Percentage of Participants Who Died||Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798629|NCT00532129|Secondary|Duration of Response (DoR)|DoR: defined as interval (in days) from first tumor response (of CR/PR/nPR) to earlier of date of PD/death. Participants without PD/death or who were lost to follow-up were censored. CR: a)Absence of LD by PE and CT, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a)≥50% decrease in Lym count from baseline value, b)≥50% reduction in LD, c)≥50% reduction in size of liver/spleen by PE/CT scan and d)Leuk, Plat and Hb ≥1.5×10^9/L, >100×10^9/L and >11.0 g/dL, respectively or 50% improvement (of all the 3) over baseline value. nPR: participants who satisfied all of CR criteria except for BM, where LN could be identified. PD: a)≥50% increase in sum of the products of ≥2 lymph nodes or appearance of new lymph nodes/extranodal lesions, or b)≥50% increase in size of HSM; new appearance of palpable HM/SM, or c)≥50% increase in number of Lym, or d)Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR, PR or nPR.|||days||95% Confidence Interval|Median
2798630|NCT00532129|Secondary|Disease Free Survival (DFS) Time|DFS time was defined as interval (in days) from first tumor response of CR to date of first tumor response of PD, or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.|||days||95% Confidence Interval|Median
2798631|NCT00532129|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the interval (in days) from trial treatment start date to earlier of the date of first tumor response assessment of PD or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||days||95% Confidence Interval|Median
2798632|NCT00532129|Secondary|Percentage of Participant With Disease Progression or Death|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798633|NCT00532129|Secondary|Percentage of Participants With Objective Response (CR or PR)|Objective response was defined as a tumor response of CR or PR. CR was achieved if all of the criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR was achieved if all of the criteria were met: a)≥50% decrease in Lymp count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered PRs.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants||95% Confidence Interval|Number
2798634|NCT00532129|Secondary|Percentage of Participants With BOR of Stable Disease (SD)|Participants without CR/PR or PD were considered having a tumor response of SD. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a) ≥50% decrease in Lym count from baseline, b) ≥50% reduction in LD, c) ≥50% reduction in size of liver/spleen by PE/CT and ≥1 of the following for at least 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798635|NCT00532129|Secondary|Percentage of Participants With BOR of Progressive Disease (PD)|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of hepatosplenomegaly (HSM) as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798670|NCT00531934|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||percentage of participants|||Number
2798671|NCT00531934|Secondary|Percentage of Participants Estimated to be Progression Free at 4 and 12 Months||Months 4 and 12|ITT Population|||percentage of participants|||Number
2798636|NCT00532129|Secondary|Percentage of Participants With BOR of Nodular Partial Response (nPR)|CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. Participants with nPR were those who satisfied all of the CR criteria except for the BM, where LN could be identified histologically.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798637|NCT00532129|Secondary|Percentage of Participants With BOR of Partial Response (PR)|PR was achieved if all of the following criteria were met: a)≥50% decrease in Lym count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered in PRs. CR was achieved if all of the criteria were fulfilled for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798638|NCT00532129|Secondary|Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR|Clinical CR was achieved if all of the following criteria were met: a)Absence of lymphadenopathy (LD) by physical examination (PE) and Computed Tomography (CT) scan (all lymph nodes less than [<] 1.5 centimeters [cm] in diameter), b)No hepatomegaly (HM)/splenomegaly (SM) by PE/CT scan, c)Absence of B symptoms (unexplained fever greater than [>] 38 degrees [°] Centigrade [C], drenching night sweats/>10 percent [%] body weight loss in the last 6 months), d)Normal Complete Blood Count (CBC) (i. Leukocytes (Leuk) greater than or equal to [≥] 1.5×10^9 per liter (/L), ii. Platelets (Plat) >100×10^9/L, and iii. Haemoglobin (Hb) >11.0 grams per deciliter [g/dL]) and e)Once clinical, radiological and laboratory evaluations demonstrated CR, bone marrow (BM) biopsy and aspirate were performed 8 weeks later for confirmation; BM sample: normocellular for age, <30% of the cells being lymphocytes (Lym) and lymphoid nodules (LN) absent was considered as a confirmed CR.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.|||percentage of participants|||Number
2798639|NCT00532129|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.|First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)|FAS.|||percentage of participants|||Number
2798640|NCT00531960|Secondary|Percentage of Participants With Disease Control According to RECIST V 1.0|Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit|FAS|||percentage of participants||95% Confidence Interval|Number
2798641|NCT00531960|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS|||percentage of participants||95% Confidence Interval|Number
2798642|NCT00531960|Secondary|OS|The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants who died were included in this analysis.|||months||95% Confidence Interval|Median
2798643|NCT00531960|Secondary|Percentage of Participants Who Died|Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS|||percentage of participants|||Number
2798644|NCT00531960|Primary|PFS|The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants with an event (disease progression or death) were included in the analysis.|||weeks||95% Confidence Interval|Median
2798645|NCT00531960|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS|||percentage of participants|||Number
2798646|NCT00531947|Secondary|Hematology - Red Blood Cell (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks||||x10^12/L||Standard Deviation|Mean
2798647|NCT00531947|Secondary|Hematology - Hemoglobin (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks||||g/dL||Standard Deviation|Mean
2798648|NCT00531947|Secondary|Hematology - Hematocrit (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks||||percent||Standard Deviation|Mean
2798649|NCT00531947|Secondary|Hematology - White Blood Cell (WBC) (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10^9/L), ABS EOSINOPHILS (X10^9/L), ABS LYMPHOCYTES (X10^9/L), ABS MONOCYTES (X10^9/L), and ABS NEUTROPHILS (X10^9/L) are presented.|12 Weeks||||(X10^9/L)||Standard Deviation|Mean
2798650|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)Ventricular Heart Rate|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.|12 Weeks||||BPM||Standard Deviation|Mean
2798651|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.|12 Weeks||||msec||Standard Deviation|Mean
2798652|NCT00531947|Secondary|Vital Signs-Blood Pressure (Change From Baseline)|Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks||||mmHg||Standard Deviation|Mean
2798653|NCT00531947|Secondary|Vital Signs-Heart Rate (Change From Baseline)|Summary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks||||BPM||Standard Deviation|Mean
2798654|NCT00531947|Secondary|Urinalysis (Change From Baseline)|A summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.|12 Weeks||||units on a scale||Standard Deviation|Mean
2798655|NCT00531947|Secondary|Physical Examination (Screening vs. EOS)|Number of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.|12 Weeks||||Number of Abnormal Exams|||Number
2798656|NCT00531947|Primary|CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12|"A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).|||units on a scale||Standard Deviation|Mean
2798657|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC).~Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.~CDRS-R (Best Description) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks||||units on a scale||Standard Deviation|Mean
2798658|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).~CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|12 Weeks||||units on a scale||Standard Deviation|Mean
2798905|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798659|NCT00531947|Secondary|CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)|"A summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).~CDRS-R (Child) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks||||units on a scale||Standard Deviation|Mean
2798660|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.~CDRS-R (Best Description)total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks||||units on a scale||Standard Deviation|Mean
2798661|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|Baseline and 12 Weeks||||units on a scale||Standard Deviation|Mean
2798662|NCT00531947|Secondary|CGI-C Percent Responders (mITT w/LOCF Population)|A summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.|12 Weeks||||Percent Responder|||Number
2798663|NCT00531947|Secondary|CGI-C - Week 12 (mITT w/LOCF Population)|"A summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; Very much improved) to 7(maximum; Very much worse). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 (Unchanged) indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall."|12 Weeks||||units on a scale||Standard Deviation|Mean
2798664|NCT00531947|Secondary|CGI-S - Week 12 (mITT w/LOCF Population)|A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.|Baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).|||units on a scale||Standard Deviation|Mean
2798665|NCT00531934|Secondary|Quality of Life Score as Assessed by Visual Analog Scale (VAS)|Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint).|Baseline, Days 14 and 28, and Months 2, 3, and 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2798666|NCT00531934|Secondary|Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect).|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2798667|NCT00531934|Secondary|Dermatology Life Quality Index (DLQI) Global Score|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined.|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2798668|NCT00531934|Secondary|Percentage of Participants Estimated to be Alive at 4 and 12 Months||Months 4 and 12|ITT Population|||percentage of participants|||Number
2798906|NCT00530842|Secondary|Static Lung Volumes|Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798673|NCT00531934|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||percentage of participants|||Number
2798674|NCT00531934|Secondary|Percentage of Participants by Best Global Response Under Treatment|Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population|||percentage of participants|||Number
2798675|NCT00531934|Secondary|Percentage of Participants With Global Disease Control by Visit|Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).|Months 2, 4, 7, 10, and 12|ITT population; number (n) = number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
2798676|NCT00531934|Secondary|Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction|Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator's opinion.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted doxycycline were included in the analysis.|||percentage of participants|||Number
2798677|NCT00531934|Secondary|Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction|Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted erlotinib were included in the analysis.|||percentage of participants|||Number
2798678|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity|Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event classified as other skin lesion during the first 4 months were included in the analysis.|||percentage of participants|||Number
2798679|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type|Other skin lesions included xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
2798680|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment|Other skin lesions included presence or absence of xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
2798681|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the Whole Treatment Period|If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population; only participants with an event (folliculitis) were included in the analysis.|||days||Standard Deviation|Median
2798682|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment|If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.|Days 0, 14, 28 and Months 2, 3, and 4|ITT Population; only participants with an event (folliculitis) were included in the analysis.|||days||Standard Deviation|Mean
2798683|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 12 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population|||percentage of participants|||Number
2798684|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population|||days||95% Confidence Interval|Median
2798685|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population|||participants|||Number
2798686|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 4 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
2798687|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||days||95% Confidence Interval|Median
2798688|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||participants|||Number
2798862|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|4 weeks|FAS using imputed values|||Unit on a Scale||Standard Error|Mean
2798689|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Months 7, 10, and 12|ITT population|||participants|||Number
2798690|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Months 7, 10, and 12|ITT population|||participants|||Number
2798691|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Months 7, 10, and 12|ITT population|||rash events|||Number
2798692|NCT00531934|Secondary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment||Months 7, 10, and 12|ITT population|||percentage of participants|||Number
2798693|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event of skin rash (folliculitis) during the first 4 months were included in the analysis.|||percentage of participants|||Number
2798694|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||percentage of participants|||Number
2798695|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population|||rash events|||Number
2798696|NCT00531934|Primary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment|Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; data for 1 participant in the erlotinib treatment group were missing.|||percentage of participants|||Number
2798697|NCT00531882|Primary|Neutrophil Delivery to the Oral Mucosa Using a Non-invasive Mouthwash Technique|Oral mucosal polymorphonuclear leukocytes (PMN) are obtained and assessed using a modification of the mouthwash method of (Wright et.al. Blood 1986;67:1023-30). For each subject, PMN counts are assessed on days 1, 2, 3 [Baseline (B)]; days 8, 9, 10 [Treatment (T)]; and days 11, 13, 15 [Recovery (R)]. The PMN counts for each subject are averaged for each study time period (B, T or R) within each study arm (Pioglitazone, Simvastatin and Ibuprofen). The mean baseline (B) PMN counts are compared to the mean treatment (T) PMN counts for each study arm, with the results expressed as the percent change in PMN counts . Paired T-tests between baseline and treatment PMN counts are used to analyze for significance. The recovery period is used to verify that the PMN counts return to baseline following the treatment period. Data from the recovery period is not shown.|3X Before treatment (Days 1,2,3) 3X During treatment (Days 8,9,10)|Healthy volunteers free of gingival disease were randomized 2:2:1 to oral Pioglitazone, Simvastatin or Ibuprofen respectively for 10 days.|||% change in mean PMN counts: B vs T|||Number
2798698|NCT00531843|Secondary|Increased Bleeding Attributed to Fondaparinux|Coagulopathic bleeding due to fondaparinux was suspected in patients requiring packed red cell transfusions after initiation of fondaparinux therapy only if the change in hematocrit prompting transfusion was not clinically commensurate with the degree of injuries that the patient had sustained (primarily orthopaedic) and/or the hematocrit did not respond appropriately post-transfusion.|3 weeks post injury||||participants|||Number
2798699|NCT00531843|Primary|Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)|Color-flow duplex venous ultrasonography examinations of upper and lower extremities were performed within 48 hours of injury, and then weekly until discharge or 3 weeks. DVT was defined as any clot occurring in the subclavian, iliac, femoral, or popliteal location. Patients were examined daily for clinical signs and symptoms of venous thromboembolism (VTE) and PE. Small, nonocclusive clots discovered in other locations were observed for progression on sequential ultrasonography examinations.|within 3 weeks post injury|Of 11 patients with initial contraindication to anticoagulation, 5 were cleared by the treating physicians to receive fondaparinux within 3 days of injury, and 6 were not.|||participants|||Number
2798700|NCT00531843|Secondary|Normal Trough and Peak Fondaparinux Concentration|Serum samples were collected 30 minutes before (trough) and 2 hours after (peak) the third dose of fondaparinux. Normative data plots comparing study participants with healthy volunteers were supplied by the company outsourced to analyze samples.|Day 3|Serum samples were obtained from 63 representative patients from our study who received Fondaparinux and compared against normative values from normal volunteers supplied by our sponsor.|||Participants|||Number
2798701|NCT00531817|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7|Serum concentration of CRP (high-sensitivity CRP [hsCRP] test) was analyzed by a central laboratory.|Baseline to Days 3 and 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. No imputation of missing data was made; only observed data are reported.|||mg/dL||Standard Deviation|Mean
2798815|NCT00531011|Secondary|Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .|This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.|at 30 days|ITT|||percentage of participants|||Number
2798702|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Day 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. LOCF was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.|||Percentage of participants|||Number
2798703|NCT00531817|Secondary|Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (0-10), a pain visual analog scale score (VAS, 0-100), and a global assessment of disease activity VAS score (0-100). Each domain was assessed with the Patient Take Home Form (PTHF). Higher scores indicate more disease activity. A negative change score indicates improvement.|Baseline through Day 7|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
2798704|NCT00531817|Secondary|Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24|The MOS Sleep Scale is a 12-item patient self-report instrument that assesses the quality and quantity of sleep over the previous 4 weeks. A sleep problems index (SLP9) was generated using 9 of the 12 items (1, 3, 4, 5, 6, 7, 8, 9, 12). Each item was normalized so that the lowest and highest possible scores were set to 0 and 100, respectively. The SLP9 score is the average of the recoded 9 items. The SLP9 score ranged from 0 to 100. Higher scores represent greater sleep problems. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
2798705|NCT00531817|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24|The FACIT-F is a 13-item patient self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
2798706|NCT00531817|Secondary|Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24|The SF-12 is a self-report measure of general health status with 1 or 2 items for each of 8 domains: Physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Two component summaries, physical (PCS-12) and mental (MCS-12) were calculated using norm-based scoring, resulting in means of 50 and standard deviations of 10 in the 1998 general United States population. Higher scores represent better health and a positive change from baseline represents improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
2798707|NCT00531817|Secondary|Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (MDHAQ items 1a-j), a pain visual analog scale score (VAS, item 2 in the MDHAQ), and a global assessment of disease activity VAS score (item 6 in the MDHAQ). Each domain is scored on a scale of 0-10. The RAPID score is the sum of the 3 domain scores divided by 3 resulting in a total score on a scale of 0-10. Higher scores indicate more disease activity and a negative change from baseline indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
2798708|NCT00531817|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24|Change of the DAS28 score from baseline was used to determine the EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. Missing data was imputed as “no response”.|||Percentage of participants|||Number
2798718|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Total WASO subscale score ranges from 0 to 24 hours. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||hours||Standard Deviation|Mean
2798709|NCT00531817|Secondary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24|DAS28 was calculated using the following formula: 0.56 × sqrt(TJC) + 0.28 × sqrt(SJC) + 0.70 × ln(ESR) + 0.014 × GH, where TJC = tender joint count on 28 joints, SJC = swollen joint count on 28 joints, ESR = erythrocyte sedimentation rate at the current visit (mm/hr), and GH = general health, ie, the patient's global assessment of disease activity (DA) in the previous 24 hours on a 100 mm visual analog scale (no DA to maximum DA). The DAS28 score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.|||Units on a scale||Standard Deviation|Mean
2798710|NCT00531817|Primary|Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.|||Percentage of participants|||Number
2798711|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.|||Percentage of participants|||Number
2798712|NCT00531752|Other Pre-specified|Treatment Duration|Treatment duration was defined as the total number of dosing days from first to last day of study drug administration in each period.|Day 1 up to Day 21|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||days||Full Range|Mean
2798713|NCT00531752|Other Pre-specified|Number of Participants With Change From Baseline in Physical Examination and Neurological Examination|Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal system.|Baseline up to 1 week after last study dose (1 week after end of Period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||participants|||Number
2798714|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or >120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum increase from baseline in systolic BP >=30 mmHg, maximum increase from baseline in diastolic BP >=20 mmHg.|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2798715|NCT00531752|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum QTc interval of 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to End of Treatment (Week 3 of period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2798716|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose).|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2798717|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798839|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h||Geometric Coefficient of Variation|Geometric Mean
2798719|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Number of awakenings subscale score ranges from 0 to 30. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||awakenings||Standard Deviation|Mean
2798720|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||hours||Standard Deviation|Mean
2798721|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3|SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total awake after sleep onset (WASO [1 item]), quality of sleep (1 item). Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||minutes||Standard Deviation|Mean
2798722|NCT00531752|Other Pre-specified|Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep, and overall sleep problem index (SPI) I (range 0 to 600) and II. Except for sleep quantity and sleep problem index I, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798723|NCT00531752|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3|SDS was a participant-rated questionnaire assessing the effect of the participant's symptoms on the 3 domains/subscales: work/school, social life/leisure activities, and family/home management. Each domain was rated on visual analog scale ranges from 0 to 10 where 0=not at all impaired and 10=extremely impaired, and total SDS score was calculated as a sum of all the domains with a score range of 0=not at all impaired to 30=extremely impaired. Disability scores were reported for each of the domains/subscales. Higher scores reflect greater impairment.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for given subscale at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798724|NCT00531752|Secondary|Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3|AAQoL is a 29-item questionnaire consisting of 4 subscales: life productivity (11 items), psychological health ([PH] 6 items), life outlook (7 items) and relationships (5 items). Participants rated each item on a scale ranging from 1 (not at all/never) to 5 (extremely/very often). The scores of each item were then transformed to a 0 to 100 point scale, higher scores indicating better quality of life. The score for each subscale was calculated as the sum of the corresponding item scores. Total score ranges were: life productivity (0 to 1100), psychological health (0 to 600), life outlook (0 to 700) and relationships (0 to 500), where higher subscale score indicates better quality of life for each subscale.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798725|NCT00531752|Secondary|Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3|AIM-A: 66 item questionnaire completed by the participant to assess the impact of ADHD on the participant's quality of life. It is comprised of 4 global quality of life (QoL) items (current quality of life item [CQoLI], range:1 to 10; global limitation item [GLI]: range:1 to 4, on the right track item [RTI], range:1 to 3, more good days [GD] than bad days [BD], range:1 to 5, higher scores indicate a better QoL for all the 4 QoL items) and 6 multi-item subscales (living with ADHD, general well-being, performance and daily functioning [PDF], relationships and communication [R/C], Impact of symptoms-bother/concern [IS-B/C] scale, and impact of symptoms-interference [IS-I] scale). Participants responded to each item of multi-item subscale using a likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Multi-item subscale scores were calculated as an average of scores for the contributing items and transformed into 0 to 100 score where higher scores indicate a better QoL.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798747|NCT00531479|Secondary|Time to Death Due to Invasive Aspergillosis (IA)|Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment. Participants who died due to causes other than IA were defined as censored at time of death.|||days||Full Range|Median
2798726|NCT00531752|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3|HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item was scored on a scale ranging from 0 (not present) to 4 (very severe) with a total score range of 0 to 56, where higher score indicates greater anxiety.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798727|NCT00531752|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3|The MADRS scale measures the depression level of a participant. It is administered as a semi-structured clinician interview. The total score is derived by adding the scores of the following 10 items: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. Each item is scored using a 6-point scale which ranges from 0 to 6 (a higher score indicates increased severity). The total score range was 0 to 60 where 0 indicates no depression and 60 indicates severely depressed.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798728|NCT00531752|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponded to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period.|Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21|Analysis population included all participants in PP analysis set and 1 additional participant in PF-03654746 (Flexible Dose) for whom the post-baseline data was available.‘N’ (number of participants analyzed)=evaluable participants for this measure and ‘n’= evaluable participants for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798729|NCT00531752|Secondary|Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). The AISRS inattention and hyperactive/impulsive total subscale score range from 0 to 27. A higher total subscale score corresponded to a worse severity of ADHD inattention or hyperactivity/impulsivity.|Baseline, Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798730|NCT00531752|Secondary|Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponds to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. Participants with sustained response were those who had at least 30 percent decrease from baseline in TASS total score, which was maintained at all visits up to the time of assessment. Sustained responders at Day 7, 14 and 21 were analyzed.|Day 7, 14, 21|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
2798731|NCT00531752|Secondary|Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
2798732|NCT00531752|Secondary|Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Participants with a score of 1 (normal - not ill at all) or 2 (borderline mentally ill) are reported.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
2798748|NCT00531479|Secondary|Time to Death: All-Cause Mortality|Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment.|||days||Full Range|Median
2798733|NCT00531752|Secondary|Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||percentage of participants|||Number
2798734|NCT00531752|Secondary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 1, 2|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2798735|NCT00531752|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 3|Per Protocol (PP) set: all participants included in full analysis set (FAS=who received at least[>=]1 dose of randomized study drug,had baseline and >=1 post-baseline measurement of primary efficacy variable)and had no major protocol violation affecting primary efficacy variable. n=participants evaluable at specified time points for each arm.|||units on a scale||Standard Deviation|Mean
2798736|NCT00531661|Other Pre-specified|Freedom From Pressure Sensor Failure||Study duration: average patient follow-up of 15 months||||participants|||Number
2798737|NCT00531661|Other Pre-specified|Freedom From a Device/System-related Complication (DSRC)||Study duration: average patient follow-up of 15 months||||participants|||Number
2798738|NCT00531661|Other Pre-specified|Rate of HFR Hospitalizations||Study duration: average patient follow-up of 15 months||||HFR hospitalizations/patient-year|||Number
2798739|NCT00531661|Secondary|Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)|THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.|6 months||||units on a scale||Standard Deviation|Mean
2798740|NCT00531661|Secondary|Days Alive Outside of the Hospital||6 months||||days||Standard Deviation|Mean
2798741|NCT00531661|Secondary|Proportion of Patients Hospitalized for Heart Failure||6 months||||participants|||Number
2798742|NCT00531661|Secondary|Change From Baseline in Pulmonary Artery Mean Pressure|Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.|6 months||||mmHg * days||Standard Deviation|Mean
2798743|NCT00531661|Primary|Freedom From Pressure Sensor Failure|A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).|||participants|||Number
2798744|NCT00531661|Primary|Freedom From a Device/System-related Complication (DSRC).|"A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:~is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)~results in the death of the subject~results in the explant of the device"|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.|||cases|Participants||Number
2798745|NCT00531661|Primary|Rate of Heart Failure Related (HFR) Hospitalizations||6 months||||HFR hospitalizations/patient/6 months|||Number
2798746|NCT00531518|Primary|Psychotic Symptoms|Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.|two years||||units on a scale||Standard Deviation|Mean
2798814|NCT00531011|Secondary|Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).||at 30 days|ITT|||percentage of participants|||Number
2798749|NCT00531479|Secondary|Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA|Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Participants who died due to causes other than IA before Week 6 were censored at their time of death in this analysis.|||participants|||Number
2798750|NCT00531479|Secondary|All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N=number of participants in MITT population at Week 12.|||participants|||Number
2798751|NCT00531479|Secondary|All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Intent-to-treat (ITT) population: participants in MITT analysis set plus participants with possible IA who could not be upgraded to probable or proven IA within 7 days and had received at least 1 dose of study medication. N=number of participants in ITT population at Week 6.|||participants|||Number
2798752|NCT00531479|Secondary|Global Response at Week 6|Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.|Baseline, Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Missing data and participants who died at Week 6 were treated as failure.|||participants|||Number
2798753|NCT00531479|Primary|All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis|Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Modified intent-to-treat (MITT) population: all randomized participants with proven or probable IA confirmed by Day 7 following enrollment who received at least 1 dose of study medication. N=number of participants in MITT population at Week 6. Participants not known to have died were censored at last study visit (Day 84).|||participants|||Number
2798754|NCT00531453|Secondary|Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)|"Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.|||percentage of participants|||Number
2798755|NCT00531453|Primary|Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction|"Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-baseline response assessment. The response-evaluable population comprises 49 subjects in the VDT treatment group and 48 subjects in the VDTC group.|||percentage of participants|||Number
2798756|NCT00531427|Secondary|Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the double-bind phase|Full Analysis Population (N = 570) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
2798757|NCT00531427|Secondary|Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.|Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).|10 weeks|Subjects in the full analysis population who took at least 1 dose of supplemental analgesic medication.|||tablets||Standard Deviation|Mean
2798758|NCT00531427|Primary|"Average Pain Over the Last 24 Hours Score of the Study Knee at Week 12 of the Double Blind Phase."|"Average pain over the last 24 hours scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily."|24 hours (week 12)|The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||Standard Deviation|Mean
2798759|NCT00531284|Secondary|Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||hours||Standard Deviation|Mean
2798907|NCT00530842|Secondary|Static Lung Volumes|Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798760|NCT00531284|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||liters||Standard Deviation|Mean
2798761|NCT00531284|Secondary|Clearance (CL) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||liters/hour||Standard Deviation|Mean
2798762|NCT00531284|Secondary|Elimination Half-life (t½) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||hours||Full Range|Median
2798763|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2798764|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2798765|NCT00531284|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||hours||Full Range|Median
2798766|NCT00531284|Secondary|Maximum Observed Plasma Concentration of Carfilzomib|Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.|Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2798767|NCT00531284|Secondary|Time to Progression|Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population.|||months||95% Confidence Interval|Median
2798768|NCT00531284|Secondary|Progression-Free Survival|Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population|||months||95% Confidence Interval|Median
2798769|NCT00531284|Secondary|Duration of Response|Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population with a partial response or better|||months||95% Confidence Interval|Median
2798770|NCT00531284|Secondary|Percentage of Participants With an Overall Response Throughout the Study|"Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.~Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR."|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population|||percentage of participants||95% Confidence Interval|Number
2798771|NCT00531284|Primary|Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles|"Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~CR: Disappearance of all target and non-target lesions and no new lesions;~PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions."|4 months|Phase 2 Safety population|||percentage of participants||95% Confidence Interval|Number
2798772|NCT00531284|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)|"Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.~A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.~The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle."|28 days|Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.|||participants|||Number
2798773|NCT00531206|Secondary|Alkaline Phosphatase Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
2798774|NCT00531206|Secondary|Total Bilirubin Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
2798775|NCT00531206|Secondary|Creatinine Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
2798776|NCT00531206|Secondary|Gamma-glutamyl Transpeptidase (GGT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
2798777|NCT00531206|Secondary|Aspartate Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
2798778|NCT00531206|Secondary|Alanine Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||international units/liter||Inter-Quartile Range|Median
2798779|NCT00531206|Secondary|Triglycerides Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
2798780|NCT00531206|Secondary|Low Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
2798781|NCT00531206|Secondary|High Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
2798782|NCT00531206|Secondary|Total Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||mg/dl||Inter-Quartile Range|Median
2798783|NCT00531206|Secondary|Body Mass Index Class (Kilograms/Square Meter)||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
2798784|NCT00531206|Secondary|Use of Lipid Lowering Agents During the Study||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
2798785|NCT00531206|Secondary|Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir||52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
2798786|NCT00531206|Secondary|Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
2798787|NCT00531206|Secondary|Discontinuations Due to an Adverse Event|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
2798788|NCT00531206|Secondary|Deaths|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
2798789|NCT00531206|Secondary|Serious Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients|||Number
2798790|NCT00531206|Secondary|Subjective Well-being|Investigator's opinion of patient's general condition (quality of life)|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||participants|||Number
2798791|NCT00531206|Secondary|CD4+ Cell Count|Change from baseline in CD4+ count over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated|||cells/mm3||Inter-Quartile Range|Median
2798792|NCT00531206|Secondary|Change in Viral Load|Log10 change from baseline in viral load over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated|||log10 copies/ml||Inter-Quartile Range|Median
2798793|NCT00531206|Primary|Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated|||Number of patients with adverse events|||Number
2798840|NCT00530920|Secondary|Volume of Distribution (V/F) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L||Geometric Coefficient of Variation|Geometric Mean
2798794|NCT00531050|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.|23 hours 30 minutes and 24 hours post-dose at Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Liters||95% Confidence Interval|Least Squares Mean
2798795|NCT00531050|Primary|Maximum Heart Rate (HR) During Salbutamol Administration in Part 2|Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.|24 hours post dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate.|||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
2798796|NCT00531050|Primary|Maximum Heart Rate During Exercise in Part 1|Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.|2 hour post-dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
2798797|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study|"The percentage of patients with an increase of >= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined.~0-12 hours: post first dose measurements up to second dose~12-24 hours: post second dose measurement up to and including the 24 hour measurement~0-24 hours: all post dose measurements up to and including the 24 hour measurement"|24 hours post dose on Day 1|Safety population. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. In a patient where data for the second 12 hour period is missing, 0-24 is not reported; hence the discrepancy of 4 and 3 subjects.|||Percentage of participants||95% Confidence Interval|Number
2798798|NCT00531050|Secondary|Change in Heart Rate During Exercise in Part 1|"Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise.~Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate."|1.5 hour post dose to max heart rate during exercise|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
2798799|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study|The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.|24-hours post-dose on Day 1 (of each treatment)|The safety population consisted of all subjects who received at least one dose of study medication after randomization.|||Percentage of participants||95% Confidence Interval|Number
2798800|NCT00531011|Primary|In-stent Late Loss (LL)|Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.|at 270 days|Descriptive statistics for this measure are based on one random lesion per patient, 167 patients performed angiographic follow-up.|||millimeters|Participants|Standard Deviation|Mean
2798801|NCT00531011|Secondary|Distal Minimum Lumen Diameter (MLD).|Distal refers to the immediate 5 mm outside of the distal end of the stent.|at 9 months.||||millimeters|Participants|Standard Deviation|Mean
2798802|NCT00531011|Secondary|Proximal Minimum Lumen Diameter (MLD).|Proximal refers to the immediate 5 mm outside of the proximal end of the stent.|at 9 months.||||millimeters|Participants|Standard Deviation|Mean
2798803|NCT00531011|Secondary|In-segment Minimum Lumen Diameter (MLD).||at 9 months.||||millimeters|Participants|Standard Deviation|Mean
2798804|NCT00531011|Secondary|In-stent Minimum Lumen Diameter (MLD).||at 9 months.||||millimeters|Participants|Standard Deviation|Mean
2798805|NCT00531011|Secondary|Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.||9 months|ITT|||percentage of participants|||Number
2798806|NCT00531011|Secondary|Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .|ITT|9 months|ITT|||percentage of participants|||Number
2798807|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|9 months|ITT|||percentage of participants|||Number
2798808|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|at 30 days|ITT|||percentage of participants|||Number
2798809|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||9 months|ITT|||percentage of participants|||Number
2798810|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||at 30 days||||percentage of participants|||Number
2798811|NCT00531011|Secondary|Device Success|defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.|at the time of PCI||||percentage of participants|Participants||Number
2798812|NCT00531011|Secondary|Procedural Success|defined as: residual in-stent %DS of < 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.|at the time of PCI||||percentage of participants|Participants||Number
2798813|NCT00531011|Secondary|Lesion Success|defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.|at the time of PCI|Intent to treat (ITT)|||Percentage of participants|Participants||Number
2798816|NCT00531011|Secondary|In-segment Late Loss (LL)|LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.|at 9 months|167 patients performed angiographic follow-up. Descriptive statistics for this measure are based on one random lesion per patient.|||millimeters|Participants|Standard Deviation|Mean
2798817|NCT00531011|Secondary|In-segment Binary Restenosis Rate|"This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges~In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent."|at 9 months|167 patients performed angiographic follow-up.|||percentage of participants|Participants||Number
2798818|NCT00531011|Secondary|In-stent Binary Restenosis Rate|This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.|at 9 months|ITT, 167 patients performed angiographic follow-up.|||percentage of participants|Participants||Number
2798819|NCT00530946|Secondary|Change in Apolipoprotein B From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases|||mg/dL||Standard Deviation|Mean
2798820|NCT00530946|Secondary|Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Ratio||Standard Deviation|Mean
2798821|NCT00530946|Secondary|Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases|||Ratio||Standard Deviation|Mean
2798822|NCT00530946|Secondary|Percent Change in Triglycerides From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
2798823|NCT00530946|Secondary|Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
2798824|NCT00530946|Secondary|Percent Change in Total Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
2798825|NCT00530946|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||Percent Change||Standard Deviation|Mean
2798826|NCT00530946|Secondary|Change in Diastolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases|||mm Hg||Standard Deviation|Mean
2798827|NCT00530946|Secondary|Change in Systolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases|||mm Hg||Standard Deviation|Mean
2798828|NCT00530946|Primary|Percent Change in Low Density Lipoprotein-Cholesterol|"Percent of value at Week 8 minus value at baseline over value at baseline"|8 weeks|Full Analysis Set, Last Observation Carried Forward|||Percent Change||Standard Error|Least Squares Mean
2798829|NCT00530946|Primary|Change in Systolic Blood Pressure|Value at Week 8 minus value at baseline|8 weeks|Full Analysis Set, Last Observation Carried Forward|||mm Hg||Standard Error|Least Squares Mean
2798830|NCT00530920|Secondary|Clinical Abnormal Findings in Laboratory and Physical Examination||Screening through the end of the study (14 days)|Treated set.|||participants|||Number
2798831|NCT00530920|Secondary|Cmax of Ritonavir|Ritonavir pharmacokinetics|Visits baseline, 5, 7, 9 and 13 or 14|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
2798832|NCT00530920|Secondary|Tmax of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h||Geometric Coefficient of Variation|Geometric Mean
2798833|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||Hours||Geometric Coefficient of Variation|Geometric Mean
2798834|NCT00530920|Secondary|Volume of Distribution (V/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L||Geometric Coefficient of Variation|Geometric Mean
2798835|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L/h||Geometric Coefficient of Variation|Geometric Mean
2798836|NCT00530920|Secondary|Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
2798837|NCT00530920|Secondary|AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h*uM||Geometric Coefficient of Variation|Geometric Mean
2798838|NCT00530920|Secondary|Time to Cmax (Tmax) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h||Geometric Coefficient of Variation|Geometric Mean
2798842|NCT00530920|Secondary|Trough Concentration (Cmin) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
2798843|NCT00530920|Secondary|Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||uM||Geometric Coefficient of Variation|Geometric Mean
2798844|NCT00530920|Secondary|Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)|Tipranavir (TPV) pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||h*uM||Geometric Coefficient of Variation|Geometric Mean
2798845|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Tipranavir|"Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu-lar models the fraction of dose absorbed cannot be estimated, therefore clear-ance for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed."|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||L/h||Geometric Coefficient of Variation|Geometric Mean
2798846|NCT00530920|Primary|Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))||Baseline (Day 0) to Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment|||Log10 copies/mL||Inter-Quartile Range|Median
2798847|NCT00530894|Secondary|Change in Quality of Life (QOL) From Baseline to 1 Year|"The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.~KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.~SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status."|Baseline and 1 Year|Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.|||Units on a scale||Standard Deviation|Mean
2798848|NCT00530894|Secondary|Total Hospital Days From the Index Procedure|Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.|1 year||||Days||Standard Deviation|Mean
2798849|NCT00530894|Secondary|Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)|Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure|1 year||||participants|||Number
2798850|NCT00530894|Secondary|Functional Change of NYHA|NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.|Baseline to 1 year|Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.|||Units on scale||95% Confidence Interval|Least Squares Mean
2798851|NCT00530894|Primary|Composite of Death and Recurrence Hospitalization.|Death from any cause or repeat hospitalization after intervention.|duration of study|Composite of Death and recurrence hospitalization was not a primary outcome for the High Risk groups.|||participants|||Number
2798852|NCT00530894|Primary|Death|Death from any cause.|1 Year||||participants|||Number
2798853|NCT00530855|Secondary|Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study||From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||Participants|||Number
2798854|NCT00530855|Secondary|Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design)."|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||Participants|||Number
2798855|NCT00530855|Primary|Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study|Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||days||Standard Deviation|Mean
2798856|NCT00530855|Primary|Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study|Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.|||Participants|||Number
2798857|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)|8 weeks|FAS using imputed values|||Participants|||Number
2798858|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)|4 weeks|FAS using imputed values|||Participants|||Number
2798859|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)|baseline|FAS using imputed values|||Participants|||Number
2798874|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
2798875|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
2798876|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
2798877|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Percent of predicted FEV1||Standard Error|Mean
2798878|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798879|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798880|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798881|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798882|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798883|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798884|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798885|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798886|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
2798887|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
2798888|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
2798889|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of TGV over TLC||Standard Error|Mean
2798890|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
2798891|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
2798892|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
2798893|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Percent of RV over TLC||Standard Error|Mean
2798894|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798895|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798896|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798897|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798898|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798899|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798900|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798901|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798902|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798903|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798904|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798912|NCT00530842|Secondary|Endurance Time (After 4 Weeks)|Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|4 weeks|FAS using imputed values|||Seconds||Inter-Quartile Range|Median
2798913|NCT00530842|Secondary|Post-dose TGV(FRC) (After 4 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
2798914|NCT00530842|Primary|Endurance Time (After 8 Weeks)|Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|8 weeks|FAS using imputed values|||Seconds||Inter-Quartile Range|Median
2798915|NCT00530842|Primary|Post-dose TGV(FRC) (After 8 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks|8 weeks|FAS using imputed values. The full analysis set (FAS) was defined to include all treated patients with any post-dosing efficacy data after at least 4 weeks for both investigational treatments in TGV(FRC) or endurance time.|||Litres||Standard Error|Mean
2798916|NCT00530816|Secondary|Overall Survival (OS)|"Overall Survival is defined as the time from the start of study treatment to date of death due to any cause.~Patients who were alive or lost to follow-up as of the data analysis cut-off date for the final OS analysis were censored at the date the patient was last known to be alive. Median OS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 19 November 2012 for Part 1 and 07 January 2013 for Part 2. Median follow-up time was 19.1 months for Part 1 and 35.9 months in Part 2.|Safety Population includes all patients enrolled on study and who received at least 1 dose of carfilzomib.|||months||95% Confidence Interval|Median
2798917|NCT00530816|Secondary|Progression-free Survival (PFS)|"Progression-free Survival (PFS) is defined as the time from start of treatment to IRC determined disease progression or death due to any cause. Patients who were lost to follow-up prior to documentation of disease progression and patients who were alive without disease progression before a data analysis cut-off date were censored at the last disease assessment.~Median PFS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population|||months||95% Confidence Interval|Median
2798918|NCT00530816|Secondary|Time to Progression (TTP)|"Time to Progression is defined as the time from the start of treatment to IRC-determined disease progression. Patients who were lost to follow-up prior to documentation of disease progression, or who died before documentation of disease progression or who were alive and did not have documentation of disease progression before the data analysis cut-off date were censored at the last disease assessment.~Median TTP was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population|||months||95% Confidence Interval|Median
2798919|NCT00530816|Secondary|Duration of Response (DOR)|"DOR is defined as the time from first evidence of PR or better to disease progression assessed by the IRC or death due to any cause. Patients lost to follow-up prior to disease progression or who were alive without disease progression before the analysis cutoff date were censored at the last disease assessment.~Progressive disease was defined as any of the following:~An increase of M-protein in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/24 hours) of > 25% from the nadir (if not zero).~Percentage of plasma cells in bone marrow ≥ 10%.~New or increased size of bone lesions or new plasmacytomas.~Patients without measurable serum and urine M-protein: 25% increase from nadir in the difference between involved and uninvolved FLC levels and absolute increase >10 mg/dL.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) attributed solely to the proliferative disorder.~Median DOR was estimated using Kaplan-Meier methods."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2.|Response Evaluable Population with a response of PR or better.|||months||95% Confidence Interval|Median
2798920|NCT00530816|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is defined as the percentage of participants with a best overall response of minimal response (MR) or better, i.e., a best overall response of sCR, CR, VGPR, PR, or MR. MR was defined as outlined by European Group for Blood and Marrow Transplantation (EBMT) criteria, defined as reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89%, maintained for 6 weeks.|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|Response Evaluable Population|||percentage of participants||95% Confidence Interval|Median
2798921|NCT00530816|Secondary|Best Overall Response Rate (ORR) in the Response Evaluable Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.~sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.~CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.~VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.~PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, End of Study, 30 days after last dose; median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|The Response Evaluable population consists of all treated patients with measurable disease at Baseline as assessed by M-protein, SFLC or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2798946|NCT00530777|Primary|Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation|Calculated as log10 plasma viral load at 34 weeks gestation - log10 plasma viral load at 38 weeks gestation|4 weeks|Women with paired plasma samples at 34 and 38 weeks gestation|||log10 copies/mL||Standard Deviation|Mean
2798922|NCT00530816|Primary|Best Overall Response Rate (ORR) in the Response Evaluable Subset Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.~sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.~CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.~VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.~PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|"The Response Evaluable Subset population consists of all treated patients with measurable disease at Baseline as assessed by M-protein or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.~Patients whose disease was only measurable by SFLC were excluded."|||percentage of participants||95% Confidence Interval|Number
2798923|NCT00530803|Secondary|Blinded Observer's Subjective Ratings of the Participant's Pain Level at 5 Minutes Post Venipuncture Procedure, Using a 6-point NRS|The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain participants were experiencing 5 minutes after the venipuncture was completed. Total number of participants subjectively evaluated as experiencing each pain level is reported.|5 minutes post venipuncture||||Participants|||Count of Participants
2798924|NCT00530803|Secondary|Blinded Observer's Subjective Ratings of the Participant's Pain Level at Needle Insertion, Using a 6-point NRS|The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at needle insertion. Total number of participants subjectively evaluated as experiencing each pain level is reported.|during needle insertion||||Participants|||Count of Participants
2798925|NCT00530803|Secondary|Blinded Observer's Subjective Ratings of Participants' Pain Level at Tourniquet Placement, Using a 6-point NRS|The NRS (Numerical Rating Scale) is a 6-point rating scale where 0= no pain and 5 = worst pain. Blinded observers reported their own subjective evaluation of the level of pain experienced by the participants at tourniquet placement. Total number of participants subjectively evaluated as experiencing each pain level is reported.|before venipuncture||||Participants|||Count of Participants
2798926|NCT00530803|Secondary|Parent Rating of Child's Pain Using a 6-point NRS|The Numerical Rating Scale (NRS) is a 6-point rating scale where 0= no pain and 5 = worst pain. Parents reported their own subjective evaluation of participants pain level. Each participant had only one parental assessment. Total number of parental assessment for each pain level on the 6-point NRS is reported as total number of participants experiencing that pain level.|immediately after venipuncture is completed|Number of parent assessment for each pain level on the 6-point NRS. Each participant had only one parental assessment.|||Participants|||Count of Participants
2798927|NCT00530803|Primary|Participants Self-rating of Pain Using the Wong-Baker FACES Pain Rating Scale.|"Participants were asked to report their level of pain using a 6-point Wong-Baker FACES Pain Rating Scale ranging from 0, no pain, to 5, the most pain you can have. The Wong-Baker FACES Pain Rating Scale is a validated tool for measuring pain in patients as young as 3 years old. A FACES pain score less than or equal to 2 is considered no pain to mild pain, and is clinically acceptable. Studies have shown average FACES pain scores for children receiving vascular access with placebo to be 2.2 to 3.5."|immediately after completion of venipuncture||||Participants|||Count of Participants
2798928|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|PK Population|||picograms/mL||Standard Deviation|Mean
2798929|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1 -12|PK Population|||picograms/mL||Standard Deviation|Mean
2798930|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|Pharmacokinetic (PK) Population: subjects who underwent blood sampling for measuring the trough plasma drug concentrations, excluding those who did not fulfill inclusion criteria, those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.|||picograms/mL||Standard Deviation|Mean
2798931|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)|"Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety 0-21 and seven for depression 0-21. Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation."|Baseline - Week 12/EW|FAS: Subpopulation: HADS Anxiety population, N = 15; HADS Depression population, N = 31. Patients in the FAS population who also have a baseline anxiety domain score of 8 or greater and patients with a baseline depression domain score of 8 or greater will be included in the HADS Anxiety Population and the HADS Depression Population, respectively.|||Points on a scale||Standard Deviation|Mean
2799023|NCT00530075|Secondary|Creatinine|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum creatinine level|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy population|||micromol/L||Full Range|Median
2798932|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)|"The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from Not at all (0) to Extremely (4). The assessment measures six identified mood factors:~Tension-Anxiety~Depression-Dejection~Anger-Hostility~Vigor-Activity~Fatigue-Inertia~Confusion-Bewilderment"|Baseline and Week 12/EW|Full Analysis Set|||Points on a scale||Standard Deviation|Mean
2798933|NCT00530790|Primary|Vital Signs and Body Weight Change From Baseline|Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.|Baseline to Week 12/EW|Safety Population|||Varied Standard Units of Measure||Standard Deviation|Mean
2798934|NCT00530790|Primary|12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline, Week 4, 8, 12, 13 (Follow-up)|Safety Population - (Baseline = 35 subjects, Week 4 = 33 subjects, Week 8 = 31 subjects, Week 12/EW = 33 subjects and Week 13 [Follow-up] = 35 subjects evaluated).|||Participants|||Number
2798935|NCT00530790|Primary|Urinalysis Clinical Lab Values|Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.|Baseline - Week 13 (Follow-up)|Safety Population (Baseline, Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 [Follow-up] = 35 subjects evaluated).|||Participants|||Number
2798936|NCT00530790|Primary|Blood Chemistry Clinical Lab Values Change From Baseline|Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).|||Varied Standard Units of Measure||Standard Deviation|Mean
2798937|NCT00530790|Primary|Haematology Clinical Lab Values Change From Baseline|Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).|||Varied Standard Units of Measure||Standard Deviation|Mean
2798938|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score|The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47|Baseline and Week 12/EW|Full Analysis Set(FAS)|||Points on a scale||Standard Deviation|Mean
2798939|NCT00530790|Secondary|Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)|||Points on a scale||Standard Deviation|Mean
2798940|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)|||Points on a scale||Standard Deviation|Mean
2798941|NCT00530790|Secondary|Clinical Global Impression Global Improvement (CGI-GI)|CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).|Baseline - Final assessment point|Full Analysis Set Population (Weeks 1, 2, 3, and 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Week 10, 12 = 30 subjects; Final assessment point = 35 subjects). Method for missing date is LOCF.|||Participants|||Number
2798942|NCT00530790|Secondary|Clinical Global Impression Scale - Severity of Illness (CGI-S)|The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).|Baseline - Final assessment point|Full Analysis Set Population (Baseline, Weeks 1, 2, 3, 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Weeks 10 and 12 = 30 subjects; Final assessment point = 35 subjects). Method of Missing Data = LOCF.|||Participants|||Number
2798943|NCT00530790|Secondary|Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score|The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.|Baseline and after Week 12|Full Analysis Set: Subjects entered to the treatment period, except for those not fulfilling the major registration criteria, those who did not take even one dose of the study medication, and those for whom no observation data were available after starting the study treatment. Method for missing data is Last Observation Carried Forward (LOCF).|||Points on a scale||Standard Deviation|Mean
2798944|NCT00530790|Primary|Drug Related Adverse Events-On-Therapy||Weeks 1 - 12 Treatment Period|Safety Population consisting of the subjects who took at least one dose of the study medication.|||Number of Events|||Number
2798945|NCT00530777|Secondary|Vertical HIV-1 Transmission|Mother-to-child HIV transmission|1 year postpartum|Note the sample size is 73 for each group rather than 74 due to loss to follow-up.|||Participants|||Number
2800043|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
2798947|NCT00530764|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.|Baseline and End of Treatment (Week 5 or premature termination)||||Score on scale||Standard Deviation|Mean
2798948|NCT00530764|Secondary|Change in Patient Global Impression of Change - PGIC|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to cancer since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported."|End of Week 5||||Participants|||Number
2798949|NCT00530764|Secondary|Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)|The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.|Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)||||Score on scale||Standard Deviation|Mean
2798950|NCT00530764|Secondary|Change in Brief Pain Inventory - Short Form (BPI-SF)|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)||||Score on scale||Standard Deviation|Mean
2798951|NCT00530764|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)||||Points on scale||Standard Deviation|Mean
2798952|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Worst Pain).|"The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)||||Points on scale||Standard Deviation|Mean
2798953|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Average Pain).|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)||||Points on scale||Standard Deviation|Mean
2798954|NCT00530764|Secondary|Change in Cumulative Average Pain Response Curves|"The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.~The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer."|Baseline to end of treatment (Week 5)||||Percent Change||Inter-Quartile Range|Median
2798955|NCT00530764|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening."|5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)||||Participants|||Number
2798956|NCT00530712|Secondary|Duplex Ultrasound ≤ 2.4 Primary Patency|Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year||||Event free percentage||95% Confidence Interval|Number
2798957|NCT00530712|Secondary|Walking Improvement|Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.|1 Year|Subjects with available WIQ data at 1 year|||percent change||Standard Deviation|Mean
2798958|NCT00530712|Secondary|Absolute Claudication Distance Improvement|Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.|1 Year||||Miles||Standard Deviation|Mean
2798959|NCT00530712|Secondary|Secondary Patency|Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year||||Event free percentage||95% Confidence Interval|Number
2799024|NCT00530075|Secondary|Haematuria|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: number of hematuria-positive patients.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy population|||Number of participants|||Number
2798960|NCT00530712|Secondary|Assisted Primary Patency|Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.|1 Year||||Event free percentage||95% Confidence Interval|Number
2798961|NCT00530712|Secondary|Increase in Ankle-Brachial Index From Baseline to 1 Year|Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.|1 Year||||Ratio||Standard Deviation|Mean
2798962|NCT00530712|Secondary|Improvement in Rutherford Clinical Category|Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.|1 year||||Percentage of participants with data|||Number
2798963|NCT00530712|Secondary|Number of Participants With Decline in Rutherford Clinical Category|Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.|30 days|Subjects with available RCC data|||Participants|||Count of Participants
2798964|NCT00530712|Secondary|Stent Fracture Rate|Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.|1, 2 and 3 Years|263 stents analyzable at 1 year|||percentage of stents implanted|Stent Implanted||Number
2798965|NCT00530712|Secondary|Major Adverse Events|MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.|1 Year||||Percentage of particants with data|||Number
2798966|NCT00530712|Secondary|Single-Stent Major Adverse Events|MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.|30 Days||||Percentage of participants with data|||Number
2798967|NCT00530712|Secondary|Single-Stent Primary Patency|Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.|1 Year||||Percentage of participants with data|||Number
2798968|NCT00530712|Primary|Major Adverse Events|Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)|30 Days||||Percentage of participants with data|||Number
2798969|NCT00530712|Primary|Primary Patency|Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.|1 Year||||Percentage of participants with data|||Number
2798970|NCT00530634|Primary|Two-year Progression-free Survival From the Date of Surgery|Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).|2 years post-surgery|Study was terminated after accruing only three patients.|||percentage of participants||95% Confidence Interval|Number
2798971|NCT00530504|Primary|Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.|Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.|30 Days||||participants|||Number
2798972|NCT00530439|Primary|Gestational Weight Gain|Weight at gestational week 35 - weight by inclusion|Gestational week 35||||kg||Inter-Quartile Range|Median
2798973|NCT00530439|Secondary|Metabolic Markers||Until 6 months post partum|||||||
2798974|NCT00530439|Primary|Neonatal Intensive Care Unit||Within 1 month postpartum|||||||
2798975|NCT00530439|Primary|Large for Gestational Age||Delivery|||||||
2798976|NCT00530439|Primary|Gestational Diabetes Mellitus||Delivery|||||||
2798977|NCT00530439|Primary|Preeclampsia/Pregnancy Induced Hypertension||Delivery|||||||
2798978|NCT00530439|Primary|Cesarean Section||At delivery|||||||
2798979|NCT00530348|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2).|||percent change||Standard Deviation|Mean
2798980|NCT00530348|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2).|||Z-score||Standard Deviation|Mean
2798981|NCT00530348|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2).|||units on a scale||Standard Deviation|Mean
2798982|NCT00530348|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2798983|NCT00530348|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.|||relapses per participant per year||95% Confidence Interval|Number
2798984|NCT00530348|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants with SAD||95% Confidence Interval|Number
2798985|NCT00530335|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 weeks||||participants|||Number
2798986|NCT00530335|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval(QTcF) was used.|over 8 weeks|All enrolled participants.|||participants|||Number
2798987|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%.|over 8 weeks|All enrolled participants.|||participants|||Number
2798988|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|over 8 weeks|All enrolled participants.|||participants|||Number
2798989|NCT00530335|Secondary|Change From Endpoint to Baseline in Stroop Color Word Test|An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||number of correct answers||Standard Deviation|Mean
2798990|NCT00530335|Secondary|Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores|"Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.~Calculate: norm-based score=Z-score*10+50 in each subscale."|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2798991|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2798992|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2798993|NCT00530335|Secondary|Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2807827|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 1|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 1|on-study week 5||||ng/mL||Standard Deviation|Mean
2798994|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2798995|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2798996|NCT00530335|Primary|Number of Participants With Adverse Events Leading to Discontinuation||over 8 weeks|All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day.|||participants|||Number
2798997|NCT00530270|Secondary|Duration of Hypoxemia (Low Blood Oxygen)|Sum of time periods when subject was hypoxemic (Sp02 value less than 92%) since the first dose date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.|||Hours||Standard Deviation|Mean
2798998|NCT00530270|Secondary|Duration of Supplemental Oxygen|Time period between the supplemental oxygen start date/time and first dose date/time, whichever is later, and the supplemental oxygen stop date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.|||Hours||Standard Deviation|Mean
2798999|NCT00530270|Secondary|Duration of Hospitalization|Duration in hours from treatment start time to hospital discharge.|Measured at the end of hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.|||Hours||Standard Deviation|Mean
2799000|NCT00530270|Secondary|Rating of Pain|Change from baseline rating of pain from randomization (baseline) to discharge from the hospital, evaluated every 4 hours. Pain was rated on the Oucher Scale for the pediatric population or numeric rating scale for the adult population, both 0 to 10 with 0 indicating no pain and 10 indicating severe pain.|Measured at the end of the hospital stay|Subject without major protocol violation and received treatment.|||Units on a scale||Standard Error|Mean
2799001|NCT00530270|Primary|Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less|Resolution of symptoms of ACS includes respiratory rate <= upper limit of normal +2, no work of breathing (retractions, nasal flaring, and use of accessory muscles), thoracic pain <= 4, no use of supplemental oxygen, no use of ventilary support, and saturation of peripheral oxygen (Sp02) >= steady state value -2. Symptoms were measured every 4 hours from the first dose of study drug to resolution of symptoms or hospital discharge.|Measured from first dose to end of the hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.|||hours (log transformed)||Standard Deviation|Log Mean
2799002|NCT00530257|Primary|Test of Everyday Attention for Children: Opposite Worlds|The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799003|NCT00530257|Primary|Test of Everyday Attention for Children: Sky Search|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799004|NCT00530257|Primary|Test of Everyday Attention for Children: Map Mission|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799005|NCT00530257|Primary|Test of Everyday Attention for Children: Creature Counting|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799006|NCT00530257|Primary|Test of Everyday Attention for Children: Score Dual Task (DT)|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799007|NCT00530257|Primary|Test of Everyday Attention for Children-Sky Search Dual Task|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799008|NCT00530257|Other Pre-specified|Stimulant Side Effect Rating Scale|Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms.|2 weeks||||Units on a scale||Standard Deviation|Mean
2799009|NCT00530257|Secondary|ADHD Rating Scale-IV, Parent and Teacher Version|This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity|2 Weeks|We had complete data for all 30 subjects for the parent rating scale. We only had 24 sets of complete data for the teacher rating scale as some teachers did not return a rating scale when the subject was on both medication and placebo|||Percentile||Standard Deviation|Mean
2799010|NCT00530257|Secondary|Behavior Rating Inventory of Executive Function||2 Weeks|Although this was included in the protocol we have not analyzed the results of this rating scale|||units on a scale||Standard Deviation|Mean
2799011|NCT00530257|Primary|Wechsler Intelligence Scale for Children-IV, Digit Span Subtest|The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.|2 weeks|The 30 subjects who completed both arms of the crossover analysis|||units on a scale||Full Range|Median
2799012|NCT00530257|Primary|Gordon Diagnostic System Continuous Performance Test|"This is a measure of sustained attention & response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a 1 is followed by a 9. There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance."|2 weeks|31 participants began the crossover phase of the trial and 30 completed both the medication and placebo arms. For one patient there was an equipment problem so that subject did not have data available|||errors||Full Range|Median
2799013|NCT00530257|Primary|Test of Everyday Attention for Children: Walk, Don't Walk|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don't Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed|||units on a scale||Full Range|Median
2799014|NCT00530218|Primary|Compliance Rate Among Patients With CMV Reactivation|CMV reactivation patients completed 6-week GCV therapy.|From first ganciclovir positive test to the end of the 6th week GCV therapy|Among the 36 patients with CMV reactivation, two patients are in-evaluable for compliance.|||participants|||Number
2799015|NCT00530218|Primary|Observation of Cytomegalovirus (CMV) in Blood as Measured by Either Blood Culture or Polymerase Chain Reaction (PCR) During the Course of Antiviral Treatment||Twice Weekly after day 21 post-transplant||||Participants|||Count of Participants
2799016|NCT00530218|Primary|Number of Participants With Adverse Events|This will be measured by the number of the CMV+ participants with adverse events occurring when receiving oral GCV.|From first ganciclovir positive test, after day 21 post-hematopoietic cell transplant|Patients are treated with Intravenous Ganciclovir followed by Oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.|||Participants|||Count of Participants
2799017|NCT00530088|Primary|Local Toxicity|Number of patients with an adverse event|30 days|All treated and eligible patients|||participants|||Number
2799018|NCT00530088|Primary|Response|"Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy.~9.23 No Response. All responses less than a Partial Response are considered as No Response.~9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia."|2 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2799019|NCT00530075|Secondary|SF-36|Assessment of the impact of gusperimus on general health using the Short form-36 (SF-36) questionaire. The SF-36 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales: (1) physical functioning, (2) role physical, (3) bodily pain, (4) general health, (5) vitality, (6) social function, (7) role emotional, and (8) mental health. Raw scores are calculated as the sum of re-coded scale items and transformed to a 0 to 100 scale. If scores for all 8 scales are available, two summary measures known as component scores are derived: the Physical Health Component Score (PCS) and the Mental Health Component Score (MCS). First each scale standardized to the relevant population. Then PCS and MCS are calculated as the weighted sum of standardized scores. All scales and the component scores are positively scored so that higher scores represent better health-related quality-of-life.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy Population|||Score on a scale||Full Range|Median
2799020|NCT00530075|Secondary|Vasculitis Damage Index (VDI)|Assessment of the degree of irreversible damage due to the vasculitis using VDI scoring system. The VDI comprises 64 items of damage (grouped into 11 organ-based systems). Total VDI score is 0 - 64. The higher scores represent the more severe damage occurred in patients. The VDI score can either increase or remain the same over time.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks, 6 months of follow-up period|Efficacy Population|||Score on a scale||Full Range|Median
2799021|NCT00530075|Secondary|CRP|Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum C-reactive protein level.|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Patients who had elevated CRP level (> 6 mg/dL) at entry|||mg/dL||Full Range|Median
2799022|NCT00530075|Secondary|ANCA|"Assessment of anti-neutrophil cytoplasmic antibody (ANCA): Number of ANCA-positive patients was counted.~ANCA are highly associatred with active WG, with c-ANCA titres observed in 90% of WG. In addition to their diagnostic value, it has been suggested that ANCA may have a predictive value for relapse in patients with systemic vasculitis."|At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks|Efficacy Population|||Number of participants|||Number
2799025|NCT00530075|Secondary|Duration of Clinical Response|Time from Complete Remission or Partial Remission to Relapse.|At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks, End of treatment period, and 3 and 6 months of follow-up period|Patients who had relapsed after achieved at least partial remission|||Days||Full Range|Median
2799026|NCT00530075|Primary|Remission of Vasculitis|"The primary efficacy outcome measure was remission of vasculitis. Complete remission was defined as a Birmingham vasculitis activity score (BVAS) of 0 sustained for at least 2 months. Partial remission was defined as a reduction in BVAS of 50% or more, sustained for at least 2 months, when compared with the BVAS at entry.~Entry required active Wegener's granulomatosis with a BVAS >= 4. Their disease had to be active, as measured with BVAS in which clinical manifestations caused by active vasculitis are scored on a list of predefined organ-specific items."|At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks|Efficacy Population|||Percentage of participants|||Number
2799027|NCT00530023|Secondary|Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15|Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.|Baseline and 15 weeks||||Scores on a scale||Standard Deviation|Mean
2799028|NCT00530023|Secondary|Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks||||Scores on a scale||Standard Deviation|Mean
2799029|NCT00530023|Secondary|Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks||||Scores on a scale||Standard Deviation|Mean
2799030|NCT00530023|Secondary|Incidence of Severe Hypoglycemia Events Baseline to Week 15|The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.|Baseline and 15 weeks||||number of events|||Number
2799031|NCT00530023|Primary|Change in A1C From Baseline to Week 15|Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.|Baseline and 15 weeks||||percent glycated hemoglobin||Standard Deviation|Mean
2799032|NCT00529958|Other Pre-specified|Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)|"All complications/adverse events that occurred within the first two-years post-operatively.~See Adverse Events section for results of this outcome."|2 years post-operatively||||Participants|||Count of Participants
2799033|NCT00529958|Secondary|Radiographic (X-ray) Changes|The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.|Baseline, 2 and 5 years post-operatively||2020-12-31|12/2020||||
2799034|NCT00529958|Secondary|Skin-to-Skin Operative Times|Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure|During surgery||||Minutes||Standard Deviation|Mean
2799035|NCT00529958|Secondary|Cincinnati Occupational Rating Scale|The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.|Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively|There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||score on a scale (out of 100)||Standard Deviation|Mean
2799036|NCT00529958|Secondary|Return to Pre-injury Tegner Activity Level|Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).|1, 2 and 5 years post-operatively|There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Participants|||Count of Participants
2799037|NCT00529958|Secondary|Mean Tegner Activity Level|Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))|Baseline, 6 months, 1 and 2 years post-operatively|There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Activity Level||Standard Deviation|Mean
2799038|NCT00529958|Secondary|Knee Laxity as Measured by the KT Arthrometer|Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.|Baseline, 1 and 2 years post-operatively|There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Millimetres (side-to-side difference)||Standard Deviation|Mean
2799039|NCT00529958|Secondary|Proportion of Patients With Moderate or Severe Kneeling Pain|Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.|Baseline, 2 and 5 years post-operatively|At 2 and 5-year follow-up, outcome data was not collected on all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Participants|||Count of Participants
2799040|NCT00529958|Secondary|Number of Participants With Each Pivot Shift Grade|"The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee.~Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament."|Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively|There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Participants|||Count of Participants
2799041|NCT00529958|Secondary|Mean International Knee Documentation Committee (IKDC) Subjective Score|Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.|Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively|There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||score on a scale (out of 100)||Standard Deviation|Mean
2799042|NCT00529958|Secondary|Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade|IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).|Baseline, 1, 2 and 5 years post-operatively|There were 110 participants randomized to each study group. At 1-, 2-, and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Participants|||Count of Participants
2799043|NCT00529958|Secondary|Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures|"COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy.~PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a complete traumatic rerupture. Confirmed by MR or diagnostic arthroscopy.~TRAUMATIC RE-INJURY - combined total of complete traumatic re-ruptures and partial traumatic tears.~ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer."|Minimum 2-year Follow-up, and 5-Year Follow-up|There were 110 participants randomized to each study group. At 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Participants|||Count of Participants
2799044|NCT00529958|Primary|Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome|The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.|Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively|There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.|||Score (0 to 100)||Standard Deviation|Mean
2799045|NCT00529802|Secondary|Percent Change in FDG-PETUptake Following 2 Weeks of Therapy|The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans.|2 weeks|Patients evaluable for tumor response at 8 weeks who also had both the baseline and 2-week FDG-PET scans.|||% change in avgSUVmax at 2 weeks||Full Range|Mean
2799046|NCT00529802|Primary|Relative Tumor Size Change Following 8 Weeks of Therapy.|The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.|8 weeks|50 patients were evaluable for response and had a baseline FDG-PET scan.|||Percent change from baseline||Full Range|Mean
2799047|NCT00529789|Other Pre-specified|Adverse Events Leading to Discontinuation|A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder.|Week 0 (Baseline) to 30 Weeks|All enrolled patients.|||participants|||Number
2799048|NCT00529789|Primary|Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
2799049|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
2799050|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alkaline Phosphatase (>420 Units/Liter [U/L]); Low Hematocrit (females <0.32; males <0.37); High Inorganic Phosphorus (>1.776 millimoles/L).|Between 18 and 30 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values in Period IV, based on all values at scheduled and unscheduled visits.|||participants|||Number
2799351|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 336 Weeks|This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.|Baseline and 336 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799051|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alanine transaminase (>165 Units/Liter [U/L]); High Creatine Phosphokinase (females: >507 U/L; males:>594 U/L); Low Glucose (<2.498 millimoles/L); Low Hematocrit (females: <0.32; males <0.37); Low Hemoglobin (females <5.896 millimoles/L [mmol/L] iron; males <7.137 mmol/L iron); High Inorganic Phosphorus (>1.776 millimoles/L); Low Leukocyte Count (<2.8 X10^9/L).|Baseline to 18 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
2799052|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
2799053|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2799054|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2799055|NCT00529789|Secondary|Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose|Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval.|Weeks 2, 4, 6, 8, 10, 14, 18|Number of patients in each duloxetine dose.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2799056|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.|||participants|||Number
2799057|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Between 18 and 30 Weeks|Number of enrolled patients with baseline and post-baseline values in Period IV.|||participants|||Number
2799058|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline to 18 Weeks|All enrolled patients.|||participants|||Number
2799059|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period IV|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Week 0 and Between 18 and 30 Weeks|All enrolled patients with data for specified category.|||participants|||Number
2799060|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period II/III|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Baseline to 18 weeks|All enrolled patients with data for specified category.|||participants|||Number
2799061|NCT00529763|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||mL/h||Standard Deviation|Mean
2799062|NCT00529763|Secondary|Mean Oral Clearance (CLo) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||mL/h||Standard Deviation|Mean
2799063|NCT00529763|Secondary|Mean (AUC[0-T]), (AUC[INF]), and (AUC[TAU])of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-T)for dasatinib. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUC(TAU)=area under the plasma concentration-time curve for a dosing interval|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||ng*h/mL||Standard Deviation|Mean
2799064|NCT00529763|Secondary|Mean (Tmax) and (T-Half) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Tmax=time of maximum observed plasma concentration. T-Half=plasma half-life.|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||hours||Standard Deviation|Mean
2799065|NCT00529763|Secondary|Mean Maximum Concentration (Cmax) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Cmax=maximum observed plasma concentration of dasatinib|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point|||ng/mL||Standard Deviation|Mean
2799066|NCT00529763|Secondary|Mean Dasatinib Plasma Concentrations|Mean dasatinib plasma concentrations following 70 mg BID dose in AD CML or Ph+ ALL participants and following 100 mg QD dose in CP CML participants|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Days 6 and 7 (0 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose),|Number of participants analyzed=all treated participants with evaluable PK data; n=number of participants evaluated at time point|||ng/mL||Standard Deviation|Mean
2799067|NCT00529763|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Grade 3/4 Hematologic Abnormalities|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|18 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML, AD CML, and Ph+ ALL Participants|||Participants|||Number
2799068|NCT00529763|Secondary|Progression-free Survival Among AD CML and Ph+ ALL Participants|The probability to progress after 12 months among AD CML and Ph+ ALL participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All AD CML and Ph+ ALL Participants. Subjects who neither progressed nor died were censored on the date of their last hematologic or cytogenetic assessment.|||percentage (probability)||95% Confidence Interval|Number
2799069|NCT00529763|Secondary|Duration of MaHR Among AD CML and Ph+ ALL Participants|Durability of MaHR, as measured by the probability of duration of MaHR > 12 months. Major HR (MAHR) includes CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 and <100,000/mm3; ANC >500/mm3 and <1,000/mm3.|Duration of MaHR was measured for AD CML and Ph+ ALL subjects with MaHR from the first day all criteria were met for MaHR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|||percentage (probability)||95% Confidence Interval|Number
2799070|NCT00529763|Secondary|Duration of CHR Among AD CML and Ph+ ALL Participants|Durability of CHR, as measured by the probability of duration of CHR >12 months. CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly.|Duration of CHR was measured for AD CML and Ph+ ALL subjects with CHR from the first day all criteria were met for CHR until the date of disease progression (PD) or death.(data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment|||percentage (probability)||95% Confidence Interval|Number
2799071|NCT00529763|Secondary|Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL)|Median time to CHR and MaHR, in weeks. Time to CHR is defined for AD CML and Ph+ALL subjects as the time from first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). Time to CHR is computed only for subjects whose best response is CHR. Major HR (MaHR) includes CHR or no evidence of leukemia (NEL). See Outcome Measure 1 for definitions of CHR and MaHR.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|Number of Participants Analyzed=All treated participants. n= number of responders.|||weeks||Full Range|Median
2799082|NCT00529659|Secondary|Change From Baseline in Participant Short Physical Performance Battery (SPPB)|The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.|||Score on a Scale||Standard Deviation|Mean
2799072|NCT00529763|Secondary|Progression-free Survival Among CP CML Participants|The probability to progress after 12 months among CP CML participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML Participants.Subjects who did not progress nor died were censored at their last tumor assessments.|||percentage (probability)||95% Confidence Interval|Number
2799073|NCT00529763|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|The Durability of MCyR as measured by the probability of duration of MCyR >12 months. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|Duration of MCyR was measured for CP CML subjects with MCyR from the first day all criteria were met for CCyR or PCyR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders. Subjects who did not progress nor died were censored at their last tumor assessments.|||percentage (probability)||95% Confidence Interval|Number
2799074|NCT00529763|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|Time to MCyR is defined for CP CML subjects with MCyR as the time from first dose of dasatinib until the first day criteria for CCyR or PCyR, whichever occurs first. Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders.|||weeks||Full Range|Median
2799075|NCT00529763|Secondary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR)|For CP CML, a Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; < 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort|||percentage of participants||95% Confidence Interval|Number
2799076|NCT00529763|Primary|Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Subjects (Ph+ ALL)|MaHR=CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils & <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 & <100,000/mm3; ANC >500/mm3 & <1,000/mm3. OHR=CHR+NEL+ return to chronic phase (RTC=<15% blasts in BM and PB; <30% blasts+promyelocytes in BM & PB; <20% basophils in PB; no extra-medullar disease other than spleen & liver)|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in these cohorts|||percentage of participants||95% Confidence Interval|Number
2799077|NCT00529763|Primary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow [BM]) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in [BM]).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort|||percentage of participants||95% Confidence Interval|Number
2799078|NCT00529659|Secondary|Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score|The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.|Baseline, Month 6|N = Number of patient with at least one non-missing measurement at the time point.|||Score on a Scale||Standard Deviation|Mean
2799079|NCT00529659|Secondary|Change From Baseline in Stair Climbing Power|"Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says go and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time."|Baseline, Month 6|The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.|||watts||Standard Deviation|Mean
2799080|NCT00529659|Secondary|Change From Baseline in Participant Gait Speed||Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.|||cm/sec||Standard Deviation|Mean
2799081|NCT00529659|Primary|Change From Baseline in Bilateral Leg Press (BLP) Measurement|BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.|||lbs||Standard Deviation|Mean
2799122|NCT00529542|Secondary|Fasting Glucose||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
2799083|NCT00529659|Primary|Change From Baseline in Participant Lean Body Mass||Baseline, Month 6|The full analysis set (FAS) included all participants that received at least one dose of the study therapy and had a post-randomization measurement of lean body mass.|||kg||Standard Deviation|Mean
2799084|NCT00529633|Primary|Difference in Serum Prealbumin|"Serum Prealbumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|Participant data is not available due to no shipping of specimen to analyzing laboratory||||||
2799085|NCT00529633|Primary|Difference in Serum CRP|"Serum CRP in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total||||Mg/L CRP|||Number
2799086|NCT00529633|Primary|Difference in Serum Albumin|"Serum albumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total||||g/dL of Albumin|||Number
2799087|NCT00529568|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
2799088|NCT00529568|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
2799089|NCT00529568|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||beats per minute||Standard Deviation|Mean
2799090|NCT00529568|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2799091|NCT00529568|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2799092|NCT00529568|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2799093|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
2799123|NCT00529542|Secondary|Triglycerides||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
2799094|NCT00529568|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
2799095|NCT00529568|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase|||participants|||Number
2799096|NCT00529568|Secondary|Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.|||participants|||Number
2799097|NCT00529568|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2799098|NCT00529568|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.|||participants|||Number
2799099|NCT00529568|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.|||weeks||Standard Deviation|Mean
2799100|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2799101|NCT00529568|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2799102|NCT00529568|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2799124|NCT00529542|Secondary|HDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/dl||Standard Deviation|Mean
2799103|NCT00529568|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2799104|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2799105|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Gi/L||Full Range|Median
2799106|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Gi/L||Full Range|Median
2799107|NCT00529568|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=100 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.|||participants|||Number
2799108|NCT00529568|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase|||participants|||Number
2799109|NCT00529568|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase|||participants|||Number
2799110|NCT00529555|Primary|Change in Pocket Depth.|Average change of Pocket Depth at 9 months from baseline|baseline & 9 months|Intent to treat|||mm||95% Confidence Interval|Least Squares Mean
2799111|NCT00529542|Post-Hoc|Body Mass Index||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||kg/m2||Standard Deviation|Mean
2799112|NCT00529542|Post-Hoc|Mean Ovarian Volume|Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mm3||Standard Deviation|Mean
2799113|NCT00529542|Post-Hoc|Diastolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mm Hg||Standard Deviation|Mean
2799114|NCT00529542|Post-Hoc|Systolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mm Hg||Standard Deviation|Mean
2799115|NCT00529542|Other Pre-specified|High-sensitivity C-reactive Protein (hsCRP)|high sensitive C-reactive protein as a measure of inflammation|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg/L||Standard Deviation|Mean
2799116|NCT00529542|Secondary|DHEAS|Dehydroepiandrosterone sulfate|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ng/ml||Standard Deviation|Mean
2799117|NCT00529542|Secondary|Androstenedione||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ng/ml||Standard Deviation|Mean
2799118|NCT00529542|Secondary|Total Testosterone||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ng/dl||Standard Deviation|Mean
2799119|NCT00529542|Secondary|AUC for Insulin|Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||uU*minute/mL||Standard Deviation|Mean
2799120|NCT00529542|Secondary|Area Under the Curve (AUC) for Glucose During OGTT|A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||mg*minute/dL||Standard Deviation|Mean
2799121|NCT00529542|Secondary|Fasting Insulin||baseline and 6 weeks|All analyses were performed by intention-to-treat.|||uU/ml||Standard Deviation|Mean
2799127|NCT00529542|Secondary|Peak Brachial Artery Conductance (BAC)|Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5-12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200-250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200-250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||ml/sec/mm Hg||Standard Deviation|Mean
2799128|NCT00529542|Primary|Brachial Artery Flow-mediated Dilation (FMD)|Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.|baseline and 6 weeks|All analyses were performed by intention-to-treat.|||% change in brachial artery diameter||Standard Deviation|Mean
2799129|NCT00529529|Secondary|Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study|"An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. The number of asthma exacerbations includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with asthma as a key word in the preferred term."|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Asthma exacerbations||Standard Deviation|Mean
2799130|NCT00529529|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85|FEV1 (in liters, L) was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 12, Day 85. The analysis included baseline FEV1 and FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening as covariates.|24 hours post-dose at Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Participants with observations at Day 85 were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2799131|NCT00529529|Primary|Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study|"A clinically significant asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with systemic corticosteroids. This includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with asthma as a key word in the preferred term."|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Percentage of patients|||Number
2799132|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Week 12|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
2799133|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Day 1|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
2799134|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Week 12|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
2799135|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Day 1|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
2799136|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 26|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 26 were included in the analysis.|||bpm||Standard Error|Least Squares Mean
2799137|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||bpm||Standard Error|Least Squares Mean
2799138|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 21|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 21 were included in the analysis.|||ms||Standard Error|Least Squares Mean
2799139|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||ms||Standard Error|Least Squares Mean
2799140|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Day 1|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||ms||Standard Error|Least Squares Mean
2799141|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Week 12|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2799142|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Day 1|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2799143|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Week 12|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2799144|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Day 1|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and forced expiratory volume in 1 second (FEV1) pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2799145|NCT00529529|Primary|Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study|Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.|Baseline (Day 1) to end of study (Week 26)|Safety population: All patients who received at least one dose of study drug.|||Percentage of patients|||Number
2799146|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799168|NCT00529451|Primary|Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
2799147|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799148|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799149|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799150|NCT00529516|Secondary|Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799151|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799152|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799153|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799154|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799155|NCT00529516|Secondary|Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.|||Cells per million||Standard Deviation|Geometric Mean
2799169|NCT00529451|Primary|Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
2799156|NCT00529516|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2799157|NCT00529516|Secondary|Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2799158|NCT00529516|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2799159|NCT00529516|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2799160|NCT00529516|Secondary|Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)|Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Subjects|||Number
2799161|NCT00529516|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Subjects|||Number
2799162|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||Subjects|||Number
2799163|NCT00529516|Primary|Duration of Solicited General Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.|||Days||Full Range|Median
2799164|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)|Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.|||Subjects|||Number
2799165|NCT00529516|Primary|Duration of Solicited Local Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that reported the specific symptom.|||Days||Full Range|Median
2799166|NCT00529516|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.|||Subjects|||Number
2799167|NCT00529464|Primary|Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)|A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.|Up to 2 years|The primary outcome measure could not be assessed because no subject received randomized treatment assignment. The study was terminated.||||||
2799170|NCT00529451|Primary|Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
2799171|NCT00529451|Secondary|Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP|To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||Percentage of participants|||Number
2799172|NCT00529451|Secondary|Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg|To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||Percentage of participants|||Number
2799173|NCT00529451|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint|To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.|||mm Hg||Standard Error|Least Squares Mean
2799174|NCT00529399|Primary|The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|Based on mixed meal tolerance test (MMTT) conducted at the one year visit||||nmol/L||95% Confidence Interval|Geometric Mean
2799175|NCT00529386|Primary|GRA|At 12 weeks there were no GRA responders. Study stopped because of futility.|12 weeks|7 CPCPPS patients enrolled and analysed before stopping study because of futility|||Participants|||Count of Participants
2799176|NCT00529373|Post-Hoc|Base Study + First Extension: Incidence Rate of Atypical Femoral Shaft Fractures Confirmed by Adjudication|Atypical subtrochanteric/diaphyseal femoral fractures (AFF) are an uncommon type of low-energy (eg, osteoporotic) femoral shaft fracture of unclear causation infrequently reported in osteoporotic persons treated with long-term anti-resorptive therapy (eg, bisphosphonates). All femoral (femur, femur-distal, femur-shaft) fractures in the base study + first extension were adjudicated against both ASBMR 2010 & 2013 criteria. All 5 major features (ie, location along femoral shaft, no/minimal trauma, transverse/short oblique fracture, non-comminuted, complete/incomplete fracture) were required for ASBMR 2010 AFF case definition; while 4 of 5 major features (ie, no/minimal trauma, substantially transverse orientation at cortical origin with possible oblique orientation medially, non-comminuted/minimally comminuted, complete/incomplete fracture, localized periosteal reaction of lateral cortex) with requirement for location along femoral shaft were required for ASBMR 2013 AFF case definition.|Up to approximately 74 months of observation|The All-Participants-as-Treated population, including all randomized participants who took at least one dose of study medication, was used for analysis (base study + first extension).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799177|NCT00529373|Post-Hoc|Base Study + First Extension: Incidence Rate of Femoral Shaft Fractures Confirmed by Adjudication|The incidence rate of femoral shaft fracture events (including both atypical and non-atypical; of any etiology including traumatic) confirmed by adjudication was determined for the base study + first extension. Results are expressed as number of participants with an event per 100 person-years of follow-up.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799178|NCT00529373|Post-Hoc|Base Study: Incidence Rate of Atypical Femoral Shaft Fractures Confirmed by Adjudication|Atypical subtrochanteric/diaphyseal femoral fractures (AFF) are an uncommon type of low-energy (eg, osteoporotic) femoral shaft fracture of unclear causation infrequently reported in osteoporotic persons treated with long-term anti-resorptive therapy (eg, bisphosphonates). All femoral (femur, femur-distal, femur-shaft) fractures in the base study were adjudicated against both ASBMR 2010 and 2013 criteria. All 5 major features (ie, location along femoral shaft, no/minimal trauma, transverse/short oblique fracture, non-comminuted, complete/incomplete fracture) were required for ASBMR 2010 AFF case definition; while 4 of 5 major features (ie, no/minimal trauma, substantially transverse orientation at cortical origin with possible oblique orientation medially, non-comminuted/minimally comminuted, complete/incomplete fracture, localized periosteal reaction of lateral cortex) with requirement for location along femoral shaft were required for ASBMR 2013 AFF case definition.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799179|NCT00529373|Post-Hoc|Base Study: Incidence Rate of Femoral Shaft Fractures Confirmed by Adjudication|The incidence rate of femoral shaft fracture events (including both atypical and non-atypical; of any etiology including traumatic) confirmed by adjudication was determined for the base study. Results are expressed as number of participants with an event per 100 person-years of follow-up.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799249|NCT00529373|Secondary|Base Study: Yearly Rate of Height Loss|Height was measured by wall-mounted stadiometer at randomization and at yearly intervals in the base study.|Up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (height) was used for analysis (base study).|||cm/year||95% Confidence Interval|Least Squares Mean
2799180|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First New Onset Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799181|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First 4-Point MACE Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated 4-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, 3. non-fatal definite stroke, or 4. hospitalization for unstable angina) was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799182|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Fatal Stroke Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal definite stroke was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799183|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Any Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated any reported episode of atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were included and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799184|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Fatal or Non-Fatal Stroke Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal or non-fatal definite stroke was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799185|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Fatal or Non-Fatal Myocardial Infarction Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal or non-fatal definite myocardial infarction was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799186|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First New Onset ECG-Confirmed Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799302|NCT00529100|Secondary|Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years|OS was defined as the time from date of enrollment to death due to any cause.|Baseline and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).|||percentage of participants||95% Confidence Interval|Number
2799187|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First All-Cause Death Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated all-cause death was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799188|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First 3-Point MACE Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated 3-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, or 3. non-fatal definite stroke) was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799189|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Fatal Myocardial Infarction Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal definite myocardial infarction was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799190|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Cardiovascular Death Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated cardiovascular death was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799191|NCT00529373|Other Pre-specified|Base Study + First Extension: Time to First Hospitalization for Unstable Angina Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated hospitalization for unstable angina was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years|||Number
2799192|NCT00529373|Secondary|Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Trochanter Using DXA|aBMD was measured at the trochanter at baseline and Month 60 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 60|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (trochanter aBMD) was used for analysis (PN032-Base + Extension).|||Percent change||95% Confidence Interval|Least Squares Mean
2799193|NCT00529373|Secondary|Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Femoral Neck Using DXA|aBMD was measured at the femoral neck at baseline and Month 60 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 60|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (femoral neck aBMD) was used for analysis (PN032-Base + Extension).|||Percent change||95% Confidence Interval|Least Squares Mean
2799194|NCT00529373|Secondary|Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Total Hip Using DXA|aBMD was measured at the total hip at baseline and Month 60 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 60|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (total hip aBMD) was used for analysis (PN032-Base + Extension).|||Percent change||95% Confidence Interval|Least Squares Mean
2799303|NCT00529100|Secondary|Phase 1: Number of Participants With Adverse Events (AE; Toxicity)|A listing of AEs is located in the Reported Adverse Event module.|Baseline to measured PD (up to 1 year)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).|||participants|||Number
2799195|NCT00529373|Secondary|Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Lumbar Spine Using DXA|aBMD was measured at the lumbar spine (L1 to L4) at baseline and Month 60 using DXA . If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from analysis. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 60|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (lumbar spine aBMD) was used for analysis (PN032-Base + Extension).|||Percent change||95% Confidence Interval|Least Squares Mean
2799196|NCT00529373|Secondary|Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in Cortical vBMD of the Total Hip Using Quantitative Computed Tomography|Compartment-specific effects of osteoporosis were assessed by measuring cortical vBMD at the total hip using quantitative computed tomography. The percent change from baseline at Month 60 (base study + extension study) was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 60|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (total hip cortical vBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799197|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in u-NTx/Cr Ratio After Log-Transformation|u-NTx, a biochemical marker of bone resorption by osteoclasts reflecting collagen breakdown products, was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. Urine NTx measurements (in BCE) were normalized to urine Cr concentration (i.e., u-NTx/Cr ratio) and the log-transformed fraction from baseline in u-NTx/Cr ratio was then determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 24|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (u-NTx/Cr) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Geometric Mean
2799198|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in BSAP After Log-Transformation|BSAP is an enzyme produced by matrix-synthesizing osteoblasts during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum BSAP was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. The log-transformed fraction from baseline in BSAP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 24|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (BSAP) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Geometric Mean
2799199|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Distal-Third Forearm Using DXA|aBMD was measured at the the distal one-third radius at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (distal one-third radius aBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799200|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in P1NP After Log-Transformation|P1NP is a cleavage fragment produced during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum P1NP was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. The log-transformed fraction change from baseline in P1NP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 24|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (P1NP) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Geometric Mean
2799201|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in s-CTx After Log-Transformation|s-CTx, a biochemical marker of bone resorption by osteoclasts reflecting collagen breakdown products, was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. The log-transformed fraction from baseline in s-CTx was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 24|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (s-CTx) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Geometric Mean
2809970|NCT00452335|Primary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Week 1|ITT population|||spontaneous bowel movements per week||Standard Deviation|Mean
2799202|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Trochanter Using DXA|aBMD was measured at the trochanter at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (trochanter aBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799203|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Total Hip Using DXA|aBMD was measured at the total hip at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (total hip aBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799204|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Femoral Neck Using DXA|aBMD was measured at the femoral neck at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (femoral neck aBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799205|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in Areal BMD (aBMD) of the Lumbar Spine Using DXA|aBMD was measured at the lumbar spine (L1 to L4) at baseline and Month 24 using DXA . If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from analysis. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (lumbar spine aBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799206|NCT00529373|Secondary|Imaging Substudy PN032-Base: Percent Change From Baseline in Cortical vBMD of the Total Hip Using Quantitative Computed Tomography|Compartment-specific effects of osteoporosis were assessed by measuring cortical vBMD at the total hip using quantitative computed tomography. The percent change from baseline at Month 24 was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (total hip cortical vBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799207|NCT00529373|Secondary|Second Extension: Time From Baseline to First Osteoporotic Clinical Fracture of Any Type (Adjudicated)|Osteoporotic clinical fractures of any type were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist; Vertebral fractures assessed across all vertebral levels (C7, T1 to T12, L1 to L5) were included in the analysis. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence proportion (cumulative incidence) of participants in the second extension study with at least one osteoporotic clinical fracture of any type is provided.|Up to approximately 34 months of observation|The The All-Participants-as-Treated Population including all randomized participants who entered the second extension study and received at least one dose of open-label treatment was used for analysis.|||Parts. with event per 100 person-years|||Number
2799208|NCT00529373|Secondary|Second Extension: Incidence of Osteoporotic Clinical Thoracic Vertebral Fracture (Adjudicated)|Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all thoracic vertebral levels (T1 to T12). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence of participants in the second extension study with osteoporotic vertebral clinical fractures is provided. Due to early termination of the study, the cumulative incidence using a time-to-event methodology was not assessed across base and extension studies.|Up to approximately 34 months of observation|The All-Participants-as-Treated Population including all randomized participants who entered the second extension study and received at least one dose of open-label treatment was used for analysis.|||Percentage of Participants|||Number
2799215|NCT00529373|Secondary|Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Lumbar Spine|BMD was measured by DXA for all participants at the lumbar spine at randomization, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp). Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses.|Baseline, Month 6, and once yearly, up to approximately 74 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (lumbar spine BMD) was used for analysis (base study + first extension-dbp).|||Percent change||95% Confidence Interval|Least Squares Mean
2799344|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks|This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799209|NCT00529373|Secondary|Second Extension: Incidence of Osteoporotic Clinical Lumbar Vertebral Fracture (Adjudicated)|Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all lumbar vertebral levels (L1 to L5). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence of participants in the second extension study with osteoporotic vertebral clinical fractures is provided. Due to early termination of the study, the cumulative incidence using a time-to-event methodology was not assessed across base and extension studies.|Up to approximately 34 months of observation|The All-Participants-as-Treated Population including all randomized participants who entered the second extension study and received at least one dose of open-label treatment was used for analysis.|||Percentage of Participants|||Number
2799210|NCT00529373|Secondary|Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Trochanter|BMD was measured by DXA at the trochanter starting at screening, and at yearly intervals until the end of the study (2nd extension study) for all participants who entered the 2nd extension study. LS means percent change in BMD from original baseline are provided through Month 108. At Months 96 and 108, approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. A longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size) was used for analysis.|Baseline and once yearly, up to approximately 108 months of observation|The FAS population consisted of all randomized participants who entered the second extension study and received at least one dose of open-label treatment and had the necessary on-treatment information (trochanter BMD).|||Percent change||95% Confidence Interval|Least Squares Mean
2799211|NCT00529373|Secondary|Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Femoral Neck|BMD was measured by DXA at the femoral neck starting at screening, and at yearly intervals until the end of the study (2nd extension study) for all participants who entered the 2nd extension study. LS means percent change in BMD from original baseline are provided through Month 108. At Months 96 and 108, approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. A longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size) was used for analysis.|Baseline and once yearly, up to approximately 108 months of observation|The FAS population consisted of all randomized participants who entered the second extension study and received at least one dose of open-label treatment and had the necessary on-treatment information (femoral neck BMD).|||Percent change||95% Confidence Interval|Least Squares Mean
2799212|NCT00529373|Secondary|Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Lumbar Spine|BMD was measured by DXA at the lumbar spine starting at randomization, and at yearly intervals until the end of the study (2nd extension study) for all participants who entered the 2nd extension study. Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses. At Months 96 and 108, approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. A longitudinal model with terms for treatment, stratum, region & interaction between treatment and time as fixed effects (LS means weighted for region & stratum size) was used for analysis.|Baseline and once yearly, up to approximately 108 months of observation|The FAS population consisted of all randomized participants who entered the second extension study and received at least one dose of open-label treatment and had the necessary on-treatment information (lumbar spine BMD).|||Percent change||95% Confidence Interval|Least Squares Mean
2799213|NCT00529373|Secondary|Base Study + First Extension + Second Extension: Change in Height From Baseline Stature|Height was measured by wall-mounted stadiometer at randomization and at yearly intervals across the base study and the two extension studies.|Baseline and once yearly, up to approximately 108 months of observation|Study was terminated early due to observed increase in risk of stroke in Protocol MK-0822-018. As a result, efficacy analyses in 2nd Extension were limited to change in BMD and incidence of osteoporotic clinical fractures; Base Study + First Extension + Second Extension: Change in Height from Baseline Stature was not analyzed.||||||
2799214|NCT00529373|Secondary|Base Study + First Extension + Second Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture|Morphometric vertebral fractures were assessed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline (base study) and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant semiquantitative [SQ] Grade 1-3) (T4 to L4) were confirmed by quantitative morphometric (QM) and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up).|Up to approximately 108 months of observation|Study was terminated early due to observed increase in risk of stroke in Protocol MK-0822-018. As a result, efficacy analyses in 2nd Extension were limited to change in BMD and incidence of osteoporotic clinical fractures; Base Study + 1st Ext + 2nd Ext: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture was not analyzed.||||||
2799216|NCT00529373|Secondary|Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Trochanter|BMD was measured by DXA for all participants at the trochanter-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp).|Baseline, Month 6, and once yearly, up to approximately 74 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (trochanter BMD) was used for analysis (base study + first extension-dbp).|||Percent change||95% Confidence Interval|Least Squares Mean
2799217|NCT00529373|Secondary|Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Total Hip|BMD was measured by DXA for all participants at the total hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp).|Baseline, Month 6, and once yearly, up to approximately 74 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (total hip BMD) was used for analysis (base study + first extension-dbp).|||Percent change||95% Confidence Interval|Least Squares Mean
2799218|NCT00529373|Secondary|Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Fracture (Adjudicated)|Osteoporotic clinical fractures (combining vertebral and non-vertebral) were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all vertebral levels (C7, T1 to T12, L1 to L5). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 74 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension) was used for analysis.|||Parts. with event per 100 person-years|||Number
2799219|NCT00529373|Secondary|Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated)|Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all vertebral levels (C7, T1 to T12, L1 to L5). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 74 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension) was used for analysis.|||Parts. with event per 100 person-years|||Number
2799220|NCT00529373|Secondary|Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm|BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study + first extension-dbp) in an approximate 10% random subset of participants at selected sites.|Baseline and once yearly, up to approximately 74 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (distal one-third radius BMD) was used for analysis (base study + first extension-dbp).|||Percent change||95% Confidence Interval|Least Squares Mean
2799221|NCT00529373|Secondary|Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Femoral Neck|BMD was measured by DXA for all participants at the femoral neck-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp).|Baseline, Month 6, and once yearly, up to approximately 74 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (femoral neck BMD) was used for analysis (base study + first extension-dbp).|||Percent change||95% Confidence Interval|Least Squares Mean
2799222|NCT00529373|Secondary|Base Study: Time to First Fatal Stroke Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal definite stroke was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799223|NCT00529373|Secondary|Base Study: Time to First Fatal or Non-Fatal Stroke Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal or non-fatal definite stroke was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799247|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Total Hip|BMD was measured by DXA for all participants at the total hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study).|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (total hip BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799224|NCT00529373|Secondary|Base Study: Time to First Fatal Myocardial Infarction Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal definite myocardial infarction was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799225|NCT00529373|Secondary|Base Study: Time to First Fatal or Non-Fatal Myocardial Infarction Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated fatal or non-fatal definite myocardial infarction was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799226|NCT00529373|Secondary|Base Study: Time to First Cardiovascular Death Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated cardiovascular death was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799227|NCT00529373|Secondary|Base Study: Time to First All-Cause Death Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated all-cause death was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799228|NCT00529373|Secondary|Base Study: Time to First Any Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated any reported episode of atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were included and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799229|NCT00529373|Secondary|Base Study: Time to First New Onset ECG-Confirmed Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799230|NCT00529373|Secondary|Base Study: Time to First Hospitalization for Unstable Angina Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated hospitalization for unstable angina was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799231|NCT00529373|Secondary|Base Study: Time to First 4-Point MACE Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated 4-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, 3. non-fatal definite stroke, or 4. hospitalization for unstable angina) was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799232|NCT00529373|Secondary|Base Study: Time to First New Onset Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication|The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799233|NCT00529373|Secondary|Base Study: Time to First 3-Point Major Adverse Cardiac Event (MACE) Confirmed by Thrombolysis in Myocardial Infarction Study Group (TIMI) Adjudication|The time to first TIMI-adjudicated 3-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, or 3. non-fatal definite stroke) was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years|||Number
2799234|NCT00529373|Secondary|Base Study: Percent Change From Baseline in N-Terminal Propeptide of Type 1 Collagen (P1NP) After Log-Transformation|P1NP is a cleavage fragment produced during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum P1NP was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. The log-transformed fraction from baseline in P1NP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 6, and once yearly up to 4 years|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (P1NP) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (base study).|||Percent change||95% Confidence Interval|Geometric Mean
2799235|NCT00529373|Secondary|Base Study: Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) After Log-Transformation|BSAP is an enzyme produced by matrix-synthesizing osteoblasts during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum BSAP was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. The log-transformed fraction from baseline in BSAP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 6, and once yearly up to 4 years|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (BSAP) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (base study).|||Percent change||95% Confidence Interval|Geometric Mean
2799236|NCT00529373|Secondary|Base Study: Percent Change From Baseline in Urinary N-Telopeptides of Type I Collagen/Creatinine (u-NTx/Cr) Ratio After Log-Transformation|u-NTx, a biochemical marker of bone resorption, was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. Urine NTx measurements (in bone collagen equivalents [BCE]) were normalized to urine Cr concentration (i.e., u-NTx/Cr ratio) and the log-transformed fraction from baseline in u-NTx/Cr ratio was then determined using a longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 6, and once yearly up to 4 years|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (u-NTx/Cr) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (base study).|||Percent change||95% Confidence Interval|Geometric Mean
2799237|NCT00529373|Secondary|Base Study: Percent Change From Baseline in Serum C-Telopeptides of Type I Collagen (s-CTx) After Log-Transformation|s-CTx, a biochemical marker of bone resorption by osteoclasts reflecting collagen breakdown products, was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. The log-transformed fraction from baseline in s-CTx was determined using a longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided.|Baseline, Month 6, and once yearly up to 4 years|The per-protocol population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (s-CTx) and excluding participants and/or data points that represent clinically important deviations from the protocol-specified criteria was used for analysis (base study).|||Percent change||95% Confidence Interval|Geometric Mean
2799248|NCT00529373|Secondary|Base Study: Number of Participants With Height Loss of > 1 cm|Height was measured by wall-mounted stadiometer at randomization and at yearly intervals in the base study.|Baseline and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (height loss) was used for analysis (base study).|||Participants|||Count of Participants
2799238|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants|BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study) in an approximate 10% random subset of bisphosphonate-intolerant participants at selected sites. Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment.|Baseline and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (distal one-third radius BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799239|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Trochanter in Bisphosphonate-Intolerant Participants|BMD was measured by DXA in bisphosphonate-intolerant participants at the trochanter-hip at screening, and at yearly intervals until the end of the study (base study). Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment.|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (trochanter BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799240|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Femoral Neck in Bisphosphonate-Intolerant Participants|BMD was measured by DXA in bisphosphonate-intolerant participants at the femoral neck-hip at screening, and at yearly intervals until the end of the study (base study). Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment.|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (femoral neck BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799241|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Total Hip in Bisphosphonate-Intolerant Participants|BMD was measured by DXA in bisphosphonate-intolerant participants at the total hip at screening, and at yearly intervals until the end of the study (base study). Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment.|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (total hip BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799242|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Lumbar Spine in Bisphosphonate-Intolerant Participants|BMD was measured by DXA in bisphosphonate-intolerant participants at the lumbar spine at randomization, and at yearly intervals until the end of the study (base study). Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses. Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment.|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (lumbar spine BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799243|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm|BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study) in an approximate 10% random subset of participants at selected sites.|Baseline and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (distal one-third radius BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799244|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Trochanter|BMD was measured by DXA for all participants at the trochanter-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study).|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (trochanter BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799245|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Femoral Neck|BMD was measured by DXA for all participants at the femoral neck-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study).|Baseline, Month 6, and once yearly, up to approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (femoral neck BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799246|NCT00529373|Secondary|Base Study: Percent Change From Baseline in BMD Measurements of the Lumbar Spine|"BMD was measured by DXA for all participants at the lumbar spine at randomization, Months 6, 12, and subsequent yearly intervals until the end of the study (base study). Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses.~at"|Baseline, Month 6, and once yearly, approximately 60 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (lumbar spine BMD) was used for analysis (base study).|||Percent change||95% Confidence Interval|Least Squares Mean
2799250|NCT00529373|Secondary|Base Study: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated)|Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all vertebral levels (C7, T1 to T12, L1 to L5). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 60 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799251|NCT00529373|Secondary|Base Study: Rate of Discontinuation From Study Treatment Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participant discontinuations from treatment due to adverse events (number of participants with an event per 100 person-years of follow-up) is provided.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799252|NCT00529373|Secondary|Base Study: Rate of Adverse Events|An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participants with adverse events (number of participants with an event per 100 person-years of follow-up) is provided.|Up to approximately 60 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799253|NCT00529373|Primary|Sarcopenia Substudy PN035: Change From Baseline in Gait Speed|Gait speed is a component of the Short Physical Performance Battery (SPPB) Score. Participants are asked to walk a distance of 4 meters at their normal pace. The test is performed 2 times, and the walk done in the shortest time is used for scoring. The activity is timed and then reduced to a categorical 0 to 4 scale based on time achieved. Higher scores indicate an improved function level. The change from baseline at yearly intervals was then assessed using a longitudinal data analysis model with terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline and once yearly up to 4 years.|The FAS for change from baseline at specific time-points including all randomized participants who took at least one dose of study medication and had the necessary baseline and on-treatment measurements available (gait speed) was used for analysis (PN035).|||Score on a scale||95% Confidence Interval|Least Squares Mean
2799254|NCT00529373|Primary|Sarcopenia Substudy PN035: Change From Baseline in Short Physical Performance Battery (SPPB) Score|The Short Physical Performance Battery (SPPB) Score is used to assess physical function in older persons. The SPPB consists of 3 types of physical activities: standing balance, gait speed, and chair rise. Component activities are timed and then reduced to a categorical 0 to 4 scale based on time achieved. A higher composite score (range 0 to 12) indicates an improved function level. The change from baseline at yearly intervals was then assessed using a longitudinal data analysis model with terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline and once yearly up to 4 years|The FAS for change from baseline at specific time-points including all randomized participants who took at least one dose of study medication and had the necessary baseline and on-treatment measurements available (SPPB) was used for analysis (PN035).|||Score on a scale||95% Confidence Interval|Least Squares Mean
2799255|NCT00529373|Primary|Sarcopenia Substudy PN035: Change From Baseline in Appendicular Lean Body Mass (aLBM)|Sarcopenia is the age-related loss of skeletal muscle mass and associated loss of strength. Progression of sarcopenia was assessed using aLBM as measured by total body DXA. The change from baseline at yearly intervals was then assessed using a longitudinal data analysis model with terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline and once yearly up to 4 years|The FAS for change from baseline at specific time-points including all randomized participants who took at least one dose of study medication and had the necessary baseline and on-treatment measurements available (aLBM) was used for analysis (PN035).|||kg||95% Confidence Interval|Least Squares Mean
2799256|NCT00529373|Primary|Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in vBMD at the Lumbar Spine Using Quantitative Computed Tomography|Compartment-specific effects of osteoporosis were assessed by measuring trabecular vBMD at the lumbar spine (L1 total vertebral body) using quantitative computed tomography. The percent change from baseline at Month 60 (base study + extension study) was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 60|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (lumbar spine vBMD) was used for analysis (PN032-Base + Extension).|||Percent change||95% Confidence Interval|Least Squares Mean
2799257|NCT00529373|Primary|Imaging Substudy PN032-Base: Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at the Lumbar Spine Using Quantitative Computed Tomography|Compartment-specific effects of osteoporosis were assessed by measuring trabecular vBMD at the lumbar spine (L1 total vertebral body) using quantitative computed tomography. The percent change from baseline at Month 24 (base study) was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|Baseline, Month 24|The FAS including consisting of all randomized participants who took at least one dose of blinded study treatment and have a baseline and at least one on-treatment measurement available (lumbar spine vBMD) was used for analysis (PN032-Base).|||Percent change||95% Confidence Interval|Least Squares Mean
2799258|NCT00529373|Primary|Second Extension: Number of Participants Discontinuing Study Treatment Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to approximately 34 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (second extension study).|||Participants|||Count of Participants
2799259|NCT00529373|Primary|Second Extension: Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to approximately 34 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for the analysis (second extension study).|||Participants|||Count of Participants
2799260|NCT00529373|Primary|Base Study + First Extension + Second Extension: Percent Change From Baseline in Bone Mineral Density (BMD) Measurements of the Total Hip|BMD was measured by dual-energy x-ray absorptiometry (DXA) at the total hip starting at screening, and at yearly intervals until the end of the study (second extension study) for all participants who entered the second extension study. Least squares (LS) means percent change in BMD from original baseline are provided through Month 108 (Year 9). At Months 96 (Year 8) and 108 (Year 9), approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study.|Baseline and once yearly, up to approximately 108 months of observation|The FAS population including all randomized participants who took at least one dose of study medication and having the necessary on-treatment information (total hip BMD) was used for analysis (base study + first extension-dbp + second extension).|||Percent change||95% Confidence Interval|Least Squares Mean
2799261|NCT00529373|Primary|Base Study + First Extension: Rate of Discontinuations From Study Treatment Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participant discontinuations from treatment due to adverse events (number of participants with an event per 100 person-years of follow-up) is provided.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799262|NCT00529373|Primary|Base Study + First Extension: Rate of Adverse Events|An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participants with adverse events (number of participants with an event per 100 person-years of follow-up) is provided.|Up to approximately 74 months of observation|The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for analysis (base study + first extension).|||Parts. with event per 100 person-years||95% Confidence Interval|Number
2799263|NCT00529373|Primary|Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)|Osteoporotic non-vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur and shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 74 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-dbp) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799264|NCT00529373|Primary|Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)|Osteoporotic clinical hip fractures was confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Hip fractures were fractures of the proximal femur confirmed as being located in the hip (i.e., sub-region not specified; cervical, and intertrochanteric). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 74 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-dbp) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799273|NCT00529308|Primary|Yale Global Tic Severity Scale (Y-GTSS)|Y-GTSS is a clinician-rated scale used to assess tic severity. Motor and phonic tics are rated separately from 0 to 5 on several scales including number, frequency, intensity, complexity, and interference. Thus Motor and Phonic Tic scores can range from 0 to 25; the combined Total Tic Score ranges from 0 to 50. There is also an Impairment score that rates the overall burden due to tics. The Impairment scale yields a single score from 0 to 50 with higher scores indicating higher levels of overall impairment associated with tics.|3 weeks||||units on a scale||Standard Deviation|Mean
2799345|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks|This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799265|NCT00529373|Primary|Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture|Morphometric vertebral fractures were confirmed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant SQ Grade 1-3) (T4 to L4) were confirmed by QM and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up).|Up to approximately 74 months of observation|The FAS including all randomized participants, who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study + first extension-double blind period [dbp]) with at least one spine radiograph on treatment (and at baseline) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799266|NCT00529373|Primary|Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)|Osteoporotic non-vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 60 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799267|NCT00529373|Primary|Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)|Osteoporotic clinical hip fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Hip fractures were fractures of the proximal femur confirmed as being located in the hip (i.e., sub-region not specified; cervical, and intertrochanteric). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided.|Up to approximately 60 months of observation|The FAS including all randomized participants who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799268|NCT00529373|Primary|Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture|Morphometric vertebral fractures were assessed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant semiquantitative [SQ] Grade 1-3) (T4 to L4) were confirmed by quantitative morphometric (QM) and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up).|Up to approximately 60 months of observation|The Full-Analysis-Set (FAS) including all randomized participants, who took at least one dose of study medication with follow-up from start of prime therapy to study termination (base study) with at least one spine radiograph on treatment (and at baseline) was used for analysis.|||Parts. w/ fracture per 100 person-years|||Number
2799269|NCT00529308|Primary|"Number of Patients With Improved or Minimally Improved in Clinical Global Impression-Improvement (CGI) Scale"|"The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to Minimal Improvement, Much Improved or Very Much Improved, respectively. CGI-I ratings of Much or Very Much Improved at post-treatment are used to identify treatment responders."|3 weeks||||participants|||Number
2799270|NCT00529308|Primary|Motor Cortex Excitability Normalization-Left Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.|||µV||Standard Deviation|Mean
2799271|NCT00529308|Primary|"Number of Patients With Much Improved or Very Much Improved on Clinical Global Impression-Improvement (CGI) Scale"|"The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to Minimal Improvement, Much Improved or Very Much Improved, respectively. CGI-I ratings of Much or Very Much Improved at post-treatment are used to identify treatment responders."|3 weeks||||participants|||Number
2799272|NCT00529308|Primary|Motor Cortex Excitability Normalization-Right Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.|||µV||Standard Deviation|Mean
2799274|NCT00529282|Secondary|Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.||||||
2799275|NCT00529282|Secondary|Clinical Success at 72 Hours|To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin|72 hours after starting study drug|No outcome measures were analyzed due to early termination of the study.||||||
2799276|NCT00529282|Secondary|Clinical Cure Regardless of Modification of Therapy|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.||||||
2799277|NCT00529282|Primary|Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.|Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject's fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.||||||
2799278|NCT00529243|Secondary|Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24|To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.|24 Weeks|Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.|||cells/mm^3||Full Range|Mean
2799279|NCT00529243|Primary|Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.|To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.|24 Weeks|Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.|||participants|||Number
2799280|NCT00529217|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.~Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.~= Normal, not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients"|6, 9, or 12 weeks||||responders (CGI-S = 1 or 2)|||Number
2799281|NCT00529217|Primary|Cambridge Depersonalization Scale (CDS)|"Change on CDS from baseline. Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement."|6, 9, or 12 weeks||||responders (>50% reduction in CDS score)|||Number
2799282|NCT00529204|Secondary|Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes||24 weeks||||adverse events|||Number
2799283|NCT00529204|Secondary|Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis|"Steatosis was grades on a scale of 0 (< 5%); 1 (5%- 33%); 2 (> 33% - 66%); and 3 (> 66%).~Inflammation was graded on a scale of 0 (No foci); 1 (< 2 foci per 200 X field); 2 (2-4 foci per 200 X field); and 3 (>4 foci per 200 X field) Fibrosis was graded on a scale of 0 (None); 1 (Mild periportal or perisinusoidal); 2 (Moderate periportal or perisinusoidal); 3 (Bridging fibrosis); and 4 (cirrhosis)"|24 weeks||||units on a scale|||Number
2799284|NCT00529204|Primary|Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy||24 weeks||||IU|||Number
2799285|NCT00529191|Secondary|HDL and LDL Cholesterol Levels in Participants Stratified by the Preservation of Islet Cell Function|"Relationship between atorvastatin's effect on HDL and LDL cholesterol and the preservation of islet cell function.~Islet cell preservation defined as: <7.5% Reduction in C-Pep"|Baseline, Week 1, Month 3, Month 6, Month 9, Month 12,||||mg/dl||Standard Deviation|Mean
2799286|NCT00529191|Secondary|Study Drug Compliance Rate Overall|Compliance is defined as >=80% expected dosage consumed during the visit period.|12 months treatment||||% of compliant participants|||Number
2799287|NCT00529191|Secondary|Number of Episodes of Hypoglycemia Requiring Any Treatment|number of episodes of hypoglycemia requiring any treatment, defined by the need for treatment with glucagon or third party intervention.|Baseline, Month 12, Month 18|All subjects contributing data|||episodes||Standard Deviation|Mean
2799288|NCT00529191|Secondary|Blood Glucose Control (Number of Participants With Hypoglycemia)|Blood glucose control as determined from home glucose meter downloads for the 1 week preceding the visit. The number of subjects with hypoglycemic episodes requiring treatment (BG < 70 mg/dl)|Baseline, Month 12, Month 18|All participants contributing data|||Participants|||Count of Participants
2799289|NCT00529191|Secondary|Levels of HbA1c at Months 3, 6, 9, 12 and 18||3, 6, 9, 12, and 18 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
2799290|NCT00529191|Secondary|Mean Daily Insulin Dose Per kg Body Weight for 7 Days|Mean daily insulin dose per kg body weight for the 1 week preceding each scheduled study visit.|Visit 1, 2, 3, 4, 5, 6, 7||||units/kg||Standard Deviation|Mean
2799291|NCT00529191|Secondary|% Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months|The C-peptide AUC measurements are collected over a 2 hour period (with 30 minute intervals) after a Mixed Meal Tolerance Test. The area under the curve from these combined measurements (from 0 to 120 or 0 to 240 minutes) is calculated and the unit of measure is nanogram*minutes/ml. The change in C-peptide AUC in response to a 2 hour MMTT at baseline vs 12 months were calculated, and efficacy (success) is defined as < 7.5% reduction.|Baseline vs 12 months||||% of participants with efficacy|||Number
2799292|NCT00529191|Primary|Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus|The change in C-peptide measurements collected over a 4 hour period (0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes) after a Mixed Meal Tolerance Test at baseline vs 12 months post-treatment were calculated. The area under the curve for these combined measurements is calculated and the unit of measure is nanogram x minutes / mL. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.|Baseline vs 12-month|Participants who completed their 12-month treatment were included in the analysis, in which the change in C-peptide AUC at baseline and 12-months were calculated. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.|||nanogram*minutes/ml||Standard Deviation|Mean
2799293|NCT00529152|Secondary|Change in Serum Ferritin Concentration From Baseline.|The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study|Baseline and 24 weeks|99 subjects had at least one post baseline measurement of serum ferritin concentration and were eligible for the efficacy analyses in the Intent to Treat population (all subjects). The Last Measurement Carried Forward methodology was used to populate any missing serum ferritin value.|||ug/L||Standard Deviation|Mean
2799294|NCT00529152|Primary|Occurrence of Adverse Events|Number of Adverse Events over 24 weeks|24 Weeks|All subjects enrolled (100), had at least one dose of Ferriprox oral solution, all were included in safety analysis|||Adverse Events|||Number
2799295|NCT00529126|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||Up to 30 days|||||||
2799296|NCT00529126|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours|"To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"|0 to 72 hours||||units on a scale*hrs||Standard Deviation|Mean
2799297|NCT00529100|Secondary|Phase 2: Site of Progressive Disease (PD)|Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and who had PD.|||participants|||Number
2799298|NCT00529100|Secondary|Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and with measurable disease.|||percentage of participants||95% Confidence Interval|Number
2799299|NCT00529100|Secondary|Progression Free Survival (PFS)|PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Baseline to measured PD (up to 36 months)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eight participants were censored.|||months||95% Confidence Interval|Median
2799300|NCT00529100|Secondary|Phase 2: Percentage of Participants With Progression Free Survival (PFS)|The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.|Baseline and 1 year and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).|||percentage of participants||95% Confidence Interval|Number
2799301|NCT00529100|Secondary|Phase 2: Time to Progressive Disease (PD)|Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eleven participants were censored.|||months||95% Confidence Interval|Median
2800420|NCT00523367|Primary|Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.|The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.|1 year||||participants|||Number
2799304|NCT00529100|Primary|Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year|OS was defined as the time from date of enrollment to death due to any cause.|Baseline to date of death from any cause (up to 1 year)|The treated population was considered the primary analysis population for the efficacy endpoints. The efficacy analysis was also completed on the protocol-qualified (PQ)population to assess the sensitivity of the results.|||percentage of participants||95% Confidence Interval|Number
2799305|NCT00529100|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy|Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.|Baseline to measured progressive disease (PD; up to 1 year)|The treated population included all participants who received at least 1 dose of either study therapy (that is, pemetrexed, cisplatin, or radiation).|||milligrams per square meter (mg/m^2)|||Number
2799306|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
2799307|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none, 1 = mild and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
2799308|NCT00529087|Secondary|Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|weeks 5-12|Patients who continued into the open-label period and received at least 1 dose of test article.|||percentage of participants|||Number
2799309|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
2799310|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1=separate hard lumps like nuts (difficult to pass) and Type 7=watery, no solid pieces (entirely liquid.) Specifically, Type 3=like a sausage but with cracks on the surface, Type 4=Like a sausage or snake, smooth and soft.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage change||Standard Error|Mean
2799311|NCT00529087|Secondary|Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.|||percentage of participants|||Number
2799312|NCT00529087|Secondary|Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.|||percentage of participants|||Number
2799346|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks|This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799313|NCT00529087|Secondary|Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||units on scale||Standard Error|Mean
2799314|NCT00529087|Secondary|Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||units on scale||Standard Error|Mean
2799315|NCT00529087|Secondary|Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). Weekly number of complete RFBM was the total number of complete RFBM reported in study period divided by the number of days with information, and multiplied by 7 for a normalized weekly number. A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||bowel movements||Standard Error|Mean
2799316|NCT00529087|Secondary|Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)|RFBM defined as bowel movement with no laxatives during the prior 24 hours. Information on laxative use, bowel movements and assessments were reported daily by patient. Weekly number of quality RFBM was the total number of quality RFBM reported in study period divided by number of days with information and multiplied by 7 for a normalized weekly number. Stool quality assessed with the Bristol Stool Form Scale (7-points) (1=difficult to pass, 7=entirely liquid). A quality RFBM defined as one other than diarrhea (Bristol Type 1-5).|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||bowel movements||Standard Error|Mean
2799317|NCT00529087|Secondary|Change in Weekly Number of Bowel Movements During Double-blind Period|Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The weekly number of BM was defined as the total number of BMs reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||bowel movements||Standard Error|Mean
2799318|NCT00529087|Secondary|Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage of participants|||Number
2799319|NCT00529087|Secondary|Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)|||percentage of participants|||Number
2799320|NCT00529087|Secondary|Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|Within 1-6 hours during 4-week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).|||percentage of injections||Standard Deviation|Mean
2799321|NCT00529087|Secondary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|Within 1-6 hours during 4 week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).|||percentage of active injections||Standard Deviation|Mean
2799347|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 528 Weeks|This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.|Baseline and 528 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2800489|NCT00522925|Secondary|Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure||4 weeks of treatment with PS43540|||||||
2799322|NCT00529087|Secondary|Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBM reported during the study week divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.|||percentage of participants|||Number
2799323|NCT00529087|Secondary|Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBMs reported during study period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number. Weekly number of RFBM determined as missing for <4 days of information.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article. Observed case analysis.|||bowel movements||Standard Deviation|Mean
2799324|NCT00529087|Secondary|Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). The weekly number of RFBM was defined as the total number of RFBM reported during the double-blind period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).|||bowel movements||Standard Error|Mean
2799325|NCT00529087|Secondary|Time to the First Rescue-free Bowel Movement (RFBM) After First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Responses following first injection were censored at 24 hours or at time of the second injection, which ever occurred first.|up to 24 hours|Patients who were randomized and received at least 1 dose of double-blinded test article.|||% of subjects achieving RFBM in 24 hours|||Number
2799326|NCT00529087|Primary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.|||percentage of active injections||Standard Deviation|Mean
2799327|NCT00529087|Primary|Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|up to 4 hours|Patients who were randomized and received at least 1 dose of double-blinded test article. For this analysis, the MOA-728 QD and MOA-728 QOD treatment groups were combined as the treatment regimen was the same through the first dose (day 1).|||percentage of participants|||Number
2799328|NCT00529035|Secondary|Treg Cell:Tcon Cell Ratio|"Changes in the ratio of the CD4+ regulatory T cell (Treg) and CD4+ conventional T cell (Tcon) counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.~All study participants (n=28) with a sample available were reported in the data table.~Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for changes to the ratio of regulatory T cell (Treg) and conventional T cell (Tcon) counts while on IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule to analyze the immunological effects of low-dose IL-2 therapy.|||ratio||Inter-Quartile Range|Median
2799329|NCT00529035|Secondary|CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.|"Changes in the above immune cell populations (CD3+T, CD4+T (including CD4+Treg and CD4+Tcon), CD8+T, NK, NKT and B cell counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.~All study participants (n=28) with a sample available were reported in the data table.~Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for regulatory T cell (Treg) expansion and other immune-cell changes while on low-dose IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule. Please note that for NK and NKT cell counts, only 18 participants samples were analyzed.|||cells/cubic millimeter||Inter-Quartile Range|Median
2799348|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 480 Weeks|This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.|Baseline and 480 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799349|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 432 Weeks|This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.|Baseline and 432 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799350|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 384 Weeks|This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.|Baseline and 384 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799330|NCT00529035|Secondary|The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.|"Feasibility: the number of participants who tolerated at least 6 weeks of therapy, and were thus evaluable for response. Efficacy: chronic GVHD response per NIH consensus criteria in evaluable patients.~A complete response was defined as resolution of all reversible chronic GVHD-associated manifestations, a partial response as an improvement of 50% or more on the organ-specific chronic GVHD scale without progression at other organs or sites, progressive disease as an increase of 25% or more on the organ specific chronic GVHD scale, and stable disease as an improvement of less than 50% or increase of less than 25%. Please refer to the Supplementary Appendix in our published report (Koreth et al, NEJM 2011) for further details."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12|Participants were evaluable for response and considered meeting the feasibility endpoint if they completed at least 6 weeks of treatment. Participants who had a partial response or complete response in cGVHD to treatment were considered to meet the efficacy endpoint.|||participants|||Number
2799331|NCT00529035|Primary|The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.|"Three dose levels were evaluated to determine the maximally tolerated dose (MTD):~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/m^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy|One participant terminated therapy early and was not evaluable for this outcome measure.|||million IU/m2/day|||Number
2799332|NCT00528970|Secondary|Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at Day 2 (24 Hours) as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)|CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.|Day 2|mITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2799333|NCT00528970|Secondary|Time to Discharge Order Written From the End of Surgery|The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge was considered treatment failures. Analysis was performed by Kaplan-Meier estimate.|Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10|mITT population included all randomized participants who received at least 1 dose of study drug.|||hours||Standard Error|Mean
2799334|NCT00528970|Secondary|Time to Discharge Eligibility|Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.|Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10|mITT population included all randomized participants who received at least 1 dose of study drug.|||hours||Standard Error|Mean
2799335|NCT00528970|Primary|Time to First Bowel Movement|Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.|Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10|mITT population included all randomized participants who received at least 1 dose of study drug.|||hours||Standard Error|Mean
2799336|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks|This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.|Baseline and 528 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799337|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks|This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.|Baseline and 480 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799338|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks|This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.|Baseline and 432 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799339|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks|This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.|Baseline and 384 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799340|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks|This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.|Baseline and 336 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799341|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks|This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.|Baseline and 288 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799342|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks|This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.|Baseline and 240 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799343|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks|This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.|Baseline and 192 weeks|Intent-to-treat, Missing = Excluded|||cells/mm^3||Standard Deviation|Mean
2799352|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 288 Weeks|This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.|Baseline and 288 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799353|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 240 Weeks|This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.|Baseline and 240 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799354|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 192 Weeks|This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.|Baseline and 192 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799355|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 144 Weeks|This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799356|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 96 Weeks|This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799357|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 48 Weeks|This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded|||percentage||Standard Deviation|Mean
2799358|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF.|528 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799359|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF.|480 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799360|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF.|432 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799361|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF.|384 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799362|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF.|336 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799363|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF.|288 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799364|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF.|240 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799365|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF.|192 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799366|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799367|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799368|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799369|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF.|528 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799370|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF.|480 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799371|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF.|432 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799372|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF.|384 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2799373|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF.|336 weeks|Intent-to-treat, Missing = Excluded|||percentage of participants|||Number
2800044|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 80 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2799374|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF.|288 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799375|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF.|240 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799376|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF.|192 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799377|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799378|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.|||percentage of participants|||Number
2799379|NCT00528957|Secondary|Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)|This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|48 weeks|Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline|||percentage of participants|||Number
2799380|NCT00528957|Secondary|Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)|This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|48 weeks|Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline|||percentage of participants|||Number
2799381|NCT00528957|Primary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure|||percentage of participants|||Number
2799382|NCT00528931|Secondary|Change From Baseline Range of Motion|Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.|||Degrees|Joints|Standard Deviation|Mean
2799383|NCT00528931|Secondary|Percent Change From Baseline Contracture|Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.|||Percentage of contracture change|Joints|Standard Deviation|Mean
2799384|NCT00528931|Secondary|Clinical Improvement|Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.|||Percentage of joints|Joints||Number
2799385|NCT00528931|Secondary|Clinical Success|Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection|||Percentage of joints|Joints||Number
2799386|NCT00528931|Primary|Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500|AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).|Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30|Pharmacokinetic population|||participants|||Number
2799387|NCT00528879|Secondary|Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and who had HbA1c values at Baseline and Week 24 (LOCF)|||Percentage of participants|||Number
2799417|NCT00528840|Secondary|Change From Baseline Range of Motion After the Last Injection|Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.|Baseline, 30 days after last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||degrees|Number of Joints|Standard Deviation|Mean
2799958|NCT00525824|Secondary|Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment|Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799388|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 1|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 1 (LOCF)|||mg/dL||Standard Error|Mean
2799389|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had a BMI ≥27 kg/m^2 at baseline, and who had nonmissing HbA1c values at Week 24 (LOCF)|||Percent||Standard Error|Mean
2799390|NCT00528879|Other Pre-specified|Number of Participants With Orthostatic Hypotension|Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.|From Baseline to Week 102|All randomized participants who received treatment; n=the number of participants who were not missing blood pressure measurements.|||Participants|||Number
2799391|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Diastolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.|||mm Hg||Standard Error|Mean
2799392|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Systolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.|||mm Hg||Standard Error|Mean
2799393|NCT00528879|Other Pre-specified|Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])|12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.|Baseline to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing baseline and Week 102 (LOCF) values|||Participants|||Number
2799394|NCT00528879|Other Pre-specified|Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality|BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.|Day 1 to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing laboratory values at baseline and Week 102.|||Participants|||Number
2799395|NCT00528879|Other Pre-specified|Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.|From Baseline to end of Long-term Period (Week 102)|All randomized participants who received at least 1 dose of blinded study medication|||Participants|||Number
2799418|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)|Baseline, within 30 days after last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints|Standard Deviation|Mean
2799419|NCT00528840|Secondary|Clinical Improvement After the Last Injection|Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection.|Baseline; within 30 days after last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percent of joints|Number of joints||Number
2799396|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline BMI ≥27 kg/m^2, and who had nonmissing total body weight measurements at Week 24 (LOCF)|||Kilograms||Standard Error|Mean
2799397|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline HbA1c ≥9.0%, and who had nonmissing HbA1c values at Week 24 (LOCF)|||Percent||Standard Error|Mean
2799398|NCT00528879|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values|||Percentage of participants|||Number
2799399|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing total body weights at baseline and Week 24 (LOCF)|||Kilograms||Standard Error|Mean
2799400|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
2799401|NCT00528879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||Percent||Standard Error|Mean
2799402|NCT00528866|Secondary|Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints||Analysis can occur at the same time as the primary endpoint if data is available.|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2799403|NCT00528866|Secondary|"Time to Late Grade 3+ Adverse Events (Based on CTCAE, v3.0)"|Two-year rate shown (cumulative incidence method). Adverse events are graded using CTCAE v3.0. Time of first late adverse event occurrence of the Grade 3+ adverse event between 91 days and 730 days from the completion of treatment (3 weeks after the last planned docetaxel dose) calculated. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799404|NCT00528866|Secondary|"Number of Patients With Acute Adverse Events (Based on CTCAE, v3.0)"|The number of patients with at least one grade 3 or higher adverse event (AE) from start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.|All eligible patients who started study treatment|||participants|||Number
2799405|NCT00528866|Secondary|Time to Biochemical (PSA) Failure (3-year Rate)|Failure is defined as PSA ≥ 0.4 ng/mL confirmed by a second higher PSA or initiation of non-protocol hormones. Death is considered a competing risk. Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799406|NCT00528866|Secondary|Overall Survival (3-year Rate)|Time from registration to date of death (failure) or last follow-up (censored). Three-year rate and 95% confidence interval were estimated by the Kaplan-Meier method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799407|NCT00528866|Secondary|Non-prostate Cancer Death (3-year Rate)|Time from registration to date of death due to other causes (failure), death due to prostate cancer (competing risk), or last follow-up (censored).Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799408|NCT00528866|Secondary|Prostate Cancer Death (3-year Rate)|Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799409|NCT00528866|Secondary|Distant Metastasis (3-year Rate)|Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799410|NCT00528866|Secondary|Local-regional Progression (3 Year Rate)|Time from registration to date of local progression (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.|Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2799411|NCT00528866|Primary|Number of Participants Free From Progression at 3 Years|Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.|From registration to 3 years.|All eligible patients who started study treatment|||participants|||Number
2799412|NCT00528840|Secondary|Change From Baseline Range of Motion After the First Injection|Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.|Baseline; within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||degrees|Joints|Standard Deviation|Mean
2799413|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the First Injection|Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.|Baseline; within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of change|joints|Standard Deviation|Mean
2799414|NCT00528840|Secondary|Clinical Improvement After the First Injection|Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection|Baseline; within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
2799415|NCT00528840|Secondary|Clinical Success After the First Injection|Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.|Within 30 days after first injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
2799416|NCT00528840|Secondary|Time to Reach Clinical Success|Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.|First evaluation visit on which clinical success is achieved through the Day 30 evaluation|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
2800006|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks||||units on scale||Standard Error|Mean
2799420|NCT00528840|Primary|Reduction in Contracture to 5° or Less|"The Primary Outcome Measure is the percentage of joints that were successfully treated where successfully treated was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection"|Within 30 days after the last injection|Intent to treat population (ITT) defined as all subjects who received at least one injection.|||percentage of joints|joints||Number
2799421|NCT00528801|Secondary|Volume of Total Cortical Gray Matter as Measured by Volumetric MRI.|The cortical gray matter is the gray matter of the cerebral cortex only and does not include subcortical gray matter such as hippocampus or basal ganglia.|Within 2 months of informed consent|Per protocol, no imputations.|||mL||Standard Deviation|Mean
2799422|NCT00528801|Secondary|Participants With Brain Lacunae as Measured by Clinical MRI|Particpants with imaging abnormalities as measured by MRI (Magnetic Resonance Imaging) specifically brain lacunae. Lacunar infarcts are 3-15 mm in diameter located at the basal ganglia, capsular and thalamic regions. Lesions located at the level of the anterior commisure are considered perivascular spaces unless >5 mm in diameter.|Within 2 months of informed consent|Per protocol, no imputation.|||Participants|||Number
2799423|NCT00528801|Primary|Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ|Extent of neurocognitive dysfunction in neurologically asymptomatic adult patients with sickle cell disease as measured by WAIS-III performance IQ. This quotient is based on an average of 100, with a standard deviation of 15. The Wechsler intelligence scales are not considered adequate measures of extremely high and low intelligence (IQ scores above 160 and below 40, respectively). The performance IQ is derived from scores on seven subtests: picture completion, picture arrangement, block design, object assembly, digit symbol, matrix reasoning, and symbol search.|Within 2 months of signing informed consent.|Per protocol, no imputation used.|||Points on a scale||Standard Deviation|Mean
2799424|NCT00528788|Primary|Change in Endothelial Cell Function|Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.|1 month|prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism|||percent change in FMD||Standard Deviation|Mean
2799425|NCT00528775|Secondary|Inflammation and Apoptosis as Assessed by Immunohistochemistry||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2799426|NCT00528775|Secondary|STAT3 Cross-links as Assessed by Western Blotting||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2799427|NCT00528775|Secondary|Photosensitizer (HPPH) Concentration in Tumor||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2799428|NCT00528775|Secondary|Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2799429|NCT00528775|Primary|Tumor Response||6 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2799430|NCT00528645|Secondary|Progression Free Survival|Progression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression or death, assessed up to 2 years||||months||95% Confidence Interval|Median
2799431|NCT00528645|Secondary|Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)|Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart..|After every other 21-day cycle, up to 2 years.||||Participants|||Count of Participants
2799432|NCT00528645|Secondary|Overall Survival|Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2799433|NCT00528645|Primary|Progression-free Survival Rate at 12 Weeks|"The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.~Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline."|12 weeks||||percentage of participants||95% Confidence Interval|Number
2799434|NCT00528606|Secondary|Change From Baseline Range of Motion After the First Injection|Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.|Baseline; within 30 days after the first injection|Modified ITT population (Change in degree of motion measured as last available post-injection range of motion - baseline range of motion)|||degrees||Standard Deviation|Mean
2799435|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the First Injection|Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.|Baseline, within 30 days after the first injection|Modified ITT population|||Percent reduction from baseline||Standard Deviation|Mean
2799436|NCT00528606|Secondary|Clinical Improvement After the First Injection|Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.|Baseline; within 30 days after the first injection|Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
2799437|NCT00528606|Secondary|Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection|Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.|Within 30 days after first injection|Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
2799438|NCT00528606|Secondary|Time to First Achieve Success After the Last Injection||Last evaluation visit on which clinical success is achieved through the Day 30 evaluation|Modified ITT population|||percentage of joints|||Number
2799439|NCT00528606|Secondary|Change From Baseline Range of Motion After the Last Injection|Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.|Baselin; within 30 days after the last injection|Modified ITT Population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||degrees||Standard Deviation|Mean
2799440|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.|Baseline; within 30 days after the last injection|Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percent reduction from baseline||Standard Deviation|Mean
2799441|NCT00528606|Secondary|Clinical Improvement After the Last Injection|Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.|Baseline; within 30 days after the last injection|Modified ITT population( Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
2799442|NCT00528606|Primary|Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where successfully treated was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.~The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where successfully treated was defined as reduction in contracture to within 0-5° of normal within 30 days of injection."|Within 30 days after the last injection|Modified-Intent-to-Treat population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)|||Percentage of Joints|||Number
2799443|NCT00528580|Primary|Time to Clinical Stability|Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.|24 hours||||days||Standard Error|Mean
2799444|NCT00528567|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|Through end of study: 30 June 2014: up to 77 months|Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.|||Participants|||Number
2799445|NCT00528567|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
2799446|NCT00528567|Secondary|Time to Distant Disease-Free Survival (DDFS) Event|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799447|NCT00528567|Secondary|Percentage of Participants With Disease-Free Survival (DFS) Events|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
2799470|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.|Baseline (pre-dose), Week 12|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||log 10 IU/mL||Standard Error|Mean
2799448|NCT00528567|Secondary|Time to Disease-Free Survival (DFS) Event|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799449|NCT00528567|Secondary|Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
2799450|NCT00528567|Secondary|Time to Breast Cancer-Free Interval (BCFI) Event|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat participants, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799451|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.|||percentage of participants|||Number
2799452|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
2799453|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||percentage of participants|||Number
2799454|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799455|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012 up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Percentage of participants|||Number
2799456|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799457|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799458|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2799459|NCT00528541|Secondary|Patient Comparison of Benefit to Previous Injections at Week 10|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this timepoint are included.|||Number of Responses|||Number
2799460|NCT00528541|Secondary|Physician Comparison of Benefit to Previous Injections at Week 10|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this time point are included.|||Number of Responses|||Number
2799461|NCT00528541|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
2799462|NCT00528541|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'."|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at the time points are included.|||Number of Responses|||Number
2799463|NCT00528541|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
2799464|NCT00528541|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
2799465|NCT00528541|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Units on a Scale||Full Range|Median
2799466|NCT00528541|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Scores on a Scale||Full Range|Median
2799467|NCT00528541|Primary|Dysphagia Incidence Over 10 Weeks|Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.|10 weeks|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.|||Number of patients|||Number
2799468|NCT00528528|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)|SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.|EOT (up to Week 48) and up to 24 weeks after EOT|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
2799469|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.|Baseline (pre-dose), EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||log 10 IU/mL||Standard Error|Mean
2799471|NCT00528528|Secondary|Percentage of Participants With Partial Response|Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
2799472|NCT00528528|Secondary|Number of Participants With Viral Breakthrough at End of Treatment (EOT)|Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.|EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Participants|||Number
2799473|NCT00528528|Secondary|Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.|||Days||Full Range|Median
2799474|NCT00528528|Primary|Percentage of Participants With Virologic Response at Week 12|Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|End of treatment (EOT) (up to Week 48)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
2799475|NCT00528450|Primary|Molecular Remission Rate|# of patients with Complete Remission|2 years||||participants|||Number
2799476|NCT00528424|Secondary|Change From Baseline Range of Motion After the First Injection|Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Degrees|Joints|Standard Deviation|Mean
2799477|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the First Injection|Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture.|Baseline, Day 30 after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of change|Joints|Standard Deviation|Mean
2799478|NCT00528424|Secondary|Clinical Improvement After the First Injection|Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, within 30 days after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of Joints|Joints||Number
2799479|NCT00528424|Secondary|Clinical Success After the First Injection|Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after first injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of Joints|Joints||Number
2799480|NCT00528424|Secondary|Time to Reach Clinical Success|Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories|Within 30 days after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of Joints|Joints||Number
2799481|NCT00528424|Secondary|Change From Baseline Range of Motion After the Last Injection|Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion − baseline range of motion|Baseline, Day 30 after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Degrees|Joints|Standard Deviation|Mean
2799482|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture.|Baseline, Day 30 after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of change|Joints|Standard Deviation|Mean
2799483|NCT00528424|Secondary|Clinical Improvement After the Last Injection|Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection|Baseline, within 30 days after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of joints|Joints||Number
2799502|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)|TLC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
2800490|NCT00522925|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure||4 weeks of treatment with PS43540|||||||
2799484|NCT00528424|Primary|Reduction in Contracture to 5° or Less|Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.|Within 30 days after last injection|Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.|||Percentage of joints|Joints||Number
2799485|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: SpO2|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Percentage||Standard Deviation|Mean
2799486|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Percent||Standard Deviation|Mean
2799487|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP|NT-proBNP is measured by clinical lab, the unit is pg/mL.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||pg/ml||Standard Deviation|Mean
2799488|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|NT-proBNP is measured by clinical lab, the unit is pg/mL.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||pg/ml||Standard Deviation|Mean
2799489|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: EF|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Percent||Standard Deviation|Mean
2799490|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Percent||Standard Deviation|Mean
2799491|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Percent||Standard Deviation|Mean
2799492|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Percent||Standard Deviation|Mean
2799493|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VT|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liters/minute||Standard Deviation|Mean
2799494|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liters/minute||Standard Deviation|Mean
2799495|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RR|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Breaths/minute||Standard Deviation|Mean
2799496|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Breaths/minute||Standard Deviation|Mean
2799497|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VE|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter/minute||Standard Deviation|Mean
2799498|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter/minute||Standard Deviation|Mean
2799499|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RV|RV is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
2799500|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Residual Volume (RV)|RV is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
2799501|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: TLC|TLC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
2799503|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FRC|FRC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
2799504|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)|FRC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
2799505|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter/second||Standard Deviation|Mean
2799506|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter/second||Standard Deviation|Mean
2799507|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Ratio||Standard Deviation|Mean
2799508|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Ratio||Standard Deviation|Mean
2799509|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FVC|FVC is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
2799510|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)|FVC is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
2799511|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1|FEV1 is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.|||Liter||Standard Deviation|Mean
2799512|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.|||Liter||Standard Deviation|Mean
2799513|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|240 hours - Day 10 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799514|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|168 hours - Day 7 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799515|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|120 hours - Day 5 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799516|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|72 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799517|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|48 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2800491|NCT00522925|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure||4 weeks of treatment with PS43540||||mmHg||95% Confidence Interval|Mean
2799518|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799519|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799520|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799521|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|2 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799522|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0 hour before last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799523|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799524|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799525|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799526|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|1 hour after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799527|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0.5 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2811290|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness"||Day 1 of a 1-day study|All participant respondents to the questions|||participants|||Number
2799528|NCT00528411|Primary|Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.|4 to 72 Hours after last dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage/Hour||Standard Error|Least Squares Mean
2799529|NCT00528411|Primary|Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|At 2 hours after first dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.|||Percentage||Inter-Quartile Range|Median
2799530|NCT00528398|Secondary|Bone Marrow at Day 7 Post-Induction Chemotherapy|Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)|7 days post completion of induction chemotherapy||||Participants|||Count of Participants
2799531|NCT00528398|Primary|Complete Remission (CR)|The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.|7 days post completion of induction chemotherapy||||Participants|||Count of Participants
2799532|NCT00528372|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])|12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who received at least 1 dose of study medication and who had measurements available|||Participants|||Number
2799533|NCT00528372|Secondary|Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)|Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Day 1 to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available|||Participants|||Number
2799534|NCT00528372|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)|Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.|Baseline to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available|||Participants|||Number
2799535|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values|||Percent||Standard Deviation|Mean
2799536|NCT00528372|Secondary|Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.|Day 1 to Week 102 (end of Long-term Period) + 30 days|Randomized participants who received at least 1 dose of study medication|||Participants|||Number
2799724|NCT00527124|Secondary|Overall Survival|Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period.|The time from registration date until death from any cause, assessed up to 52 weeks||||percentage of patients||95% Confidence Interval|Number
2799537|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 values|||Kilograms||Standard Error|Mean
2799538|NCT00528372|Secondary|Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c values at both baseline and Week 24 (LOCF)|||Percentage of participants|||Number
2799539|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 LOCF values|||Percent||Standard Error|Mean
2799540|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week24 LOCF values.|||Percent||Standard Error|Mean
2799541|NCT00528372|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who had nonmissing baseline and Week 24 LOCF values|||Percentage of participants|||Number
2799542|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment with nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Deviation|Mean
2799551|NCT00528190|Primary|The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period.|The Primary outcome measure will be the number of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period.|24 weeks||||Participants|||Count of Participants
2799552|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion up to 5 Years|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 5 years|All participants from the full analysis set who had an assessment for this evaluation|||Participants|||Number
2799543|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Error|Mean
2799544|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment nonmissing baseline and Week 24 LOCF values.|||Kilograms||Standard Deviation|Mean
2799545|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 values|||Kilograms||Standard Error|Mean
2799546|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2|Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Deviation|Mean
2799547|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values|||mg/dL||Standard Error|Mean
2799548|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values|||Percent||Standard Error|Mean
2799549|NCT00528268|Secondary|The Study Will Determine Potential Benefit of NaPB on Lean Body Mass; Overall Motor Function; Potential Cellular Response to NaPB; and Drug Compliance.||24 months|||||||
2799550|NCT00528268|Primary|The Study Will Assess the Safety, Tolerability and Potential Efficacy of Sodium Phenylbutyrate (NaPB) in Presymptomatic Infants Genetically Confirmed to Have SMA. It Will Also Determine Selected Pharmacokinetic Parameters.|Number of participants with SAE's related to research.|24 months||||participants|||Number
2799740|NCT00526994|Secondary|Utilization of Health Care|number of ambulatory care visits|during past year||||visits||95% Confidence Interval|Mean
2799553|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment up to 5 Years|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 5|All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation|||Participants|||Number
2799554|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1711 to Day 1800|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799555|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1081 to Day 1170|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799556|NCT00528112|Primary|Pearl Index for LCS16 up to 5 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.|Up to 5 years|Full analysis set|||Pregnancies per 100 women years||95% Confidence Interval|Number
2799557|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 3 years|All participants from the full analysis set who had an assessment for this evaluation|||Participants|||Number
2799558|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 3|All participants from the full analysis set who had an assessment for this evaluation|||Participants|||Number
2799559|NCT00528112|Secondary|Classification of Endometrium - Year 3 / End of Study|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 3 / End of study|A subset of women from the full analysis set|||Participants|||Number
2799560|NCT00528112|Secondary|Classification of Endometrium - Year 2|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 2|A subset of women from the full analysis set|||Participants|||Number
2799561|NCT00528112|Secondary|Classification of Endometrium - Year 1|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 1|A subset of women from the full analysis set|||Participants|||Number
2799562|NCT00528112|Secondary|Average Total Cervical Score - Year 3|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 3|A subset of women from the full analysis set|||Scores on a scale||Standard Deviation|Mean
2799563|NCT00528112|Secondary|Average Total Cervical Score - Year 2|"Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.~Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)"|For six weeks in the second half of Year 2|A subset of women from the full analysis set|||Scores on a scale||Standard Deviation|Mean
2799564|NCT00528112|Secondary|Average Total Cervical Score - Year 1|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 1|A subset of women from the full analysis set|||Scores on a scale||Standard Deviation|Mean
2799565|NCT00528112|Secondary|Number of Participants With/Without Ovulation - Year 3|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 3|A subset of women from the full analysis set|||Participants|||Number
2799566|NCT00528112|Secondary|Number of Participants With/Without Ovulation - Year 2|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 2|A subset of women from the full analysis set|||Participants|||Number
2799567|NCT00528112|Secondary|Number of Participants With/Without Ovulation - Year 1|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 1|A subset of women from the full analysis set|||Participants|||Number
2799568|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 331 to Day 360|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799569|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 120|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799570|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 61 to Day 90|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2819475|NCT00386776|Secondary|Time Per Visit|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
2799571|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 31 to Day 60|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799572|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 30|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799573|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 991 to Day 1080|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799574|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 271 to Day 360|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799575|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 181 to Day 270|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799576|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 180|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799577|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 90|All participants from the full analysis set who had an assessment for this evaluation|||Days||Standard Deviation|Mean
2799578|NCT00528112|Primary|Pearl Index up to 3 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.|Up to 3 years|Full analysis set|||Pregnancies per 100 women years||95% Confidence Interval|Number
2799579|NCT00528021|Primary|Clinical Cure|No live lice 14 days following last treatment|Day 15 or 22||||participant|||Number
2799580|NCT00527982|Primary|Histological Responses|Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.|Baseline to 12 months|No analysis. One registered patient inevaluable for response, study terminated early.||||||
2799581|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799582|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799583|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799601|NCT00527826|Secondary|Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
2799584|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of RIR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced RIR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm|||Percentage of Participants|||Number
2799585|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799586|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799587|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause Death, MI, stroke, or UCR I within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799588|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, RIR, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause death, MI, stroke, RIR, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799589|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799590|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799602|NCT00527826|Secondary|Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
2799658|NCT00527605|Secondary|Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6|Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||percent change||Standard Deviation|Mean
2799591|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization|"Adverse events were categorized as bleeding events if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. Clinically Significant Bleeding was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 2 years from randomization."|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2799592|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization|"Adverse events were categorized as bleeding events if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 2 years from randomization."|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2799593|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), and/or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the secondary composite efficacy endpoint within 2 years from randomization.|up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799594|NCT00527943|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with re-hospitalization (RIR), and/or urgent coronary revascularization (UCR). A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the primary composite efficacy endpoint within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799595|NCT00527904|Primary|Number of Subjects Monitored for Long-term Safety of PN 400|Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.|12 months|Approximately 200 subjects were planned, 239 were enrolled and treated and 143 subjects completed the study. All 239 subjects were evaluable for safety.|||participants|||Number
2799596|NCT00527878|Secondary|Clinical Severity Score|Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe.|one year on ranitidine and one year on placebo|Patients who completed the study|||score on a scale||Full Range|Mean
2799597|NCT00527878|Secondary|New Lung Infections|Number of new infection while on placebo or study drug|12 months placebo and 12 months ranitidine|Patients who completed the study|||new lung infections||Full Range|Median
2799598|NCT00527878|Secondary|New Skin Infections|Patients reported the number of new skin infections|12 months placebo/12 months ranitidine|Patients that completed the study|||skin infections||Full Range|Median
2799599|NCT00527878|Primary|Number of Infections in Subjects With HIES.|Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage).|1 year on intervention|Patients that completed both arms of the study (24 months)|||infections||Full Range|Median
2799600|NCT00527826|Secondary|Mean Total Costs (Related to COPD) Per Participant|"Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used as required were assumed to be used every second day."|Baseline through Week 52|ITT Population|||Euros per participant||Standard Deviation|Mean
2799792|NCT00526591|Secondary|Change in PSA|Time-to-event data, such as change in PSA will be summarized using the method of Kaplan and Meier.|Up to 16 weeks after start of study|One patient in the high dose cohort was not analyzed for change in PSA because they withdrew early due to progressive disease|||ng/mL||Inter-Quartile Range|Median
2799603|NCT00527826|Secondary|Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
2799604|NCT00527826|Secondary|Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population|||percent||Standard Deviation|Mean
2799605|NCT00527826|Secondary|Mean Change From Baseline in the Tiffeaneau Index at Week 52|The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.|Baseline and Week 52|ITT Population|||percent of IVC||Standard Deviation|Mean
2799606|NCT00527826|Secondary|Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52|Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.|Baseline and Week 52|ITT Population|||liters||Standard Deviation|Mean
2799607|NCT00527826|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.|Baseline and Week 52|ITT Population|||percent of predicted value||Standard Deviation|Mean
2799608|NCT00527826|Secondary|Mean Number of Days Rescue Medication Was Used|Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.|The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])|ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).|||number of days||Standard Deviation|Mean
2799609|NCT00527826|Secondary|Number of Participants With the Indicated Number of Hospital Stays|The number of participants with the indicated number of hospitalizations was recorded.|Baseline through Week 52|ITT Population|||participants|||Number
2799610|NCT00527826|Secondary|Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)|The number participants with the indicated number of days at the ICU was recorded.|Baseline through Week 52|ITT Population of participants who were admitted to the ICU|||participants|||Number
2799611|NCT00527826|Secondary|Mean Number of COPD-related Visits at/by Physician|The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.|Baseline through Week 52|ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)|||number of visits||Standard Deviation|Mean
2799612|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Poisson Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|ITT Population|||Number of exacerbations per year||Standard Error|Least Squares Mean
2799613|NCT00527826|Secondary|Compliance and Adherence to Study Medication|Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.|Baseline through Week 52|ITT Population|||percentage of doses||Standard Deviation|Mean
2799614|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Negative Binomial Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD|||Number of exacerbations per year||Standard Error|Least Squares Mean
2799615|NCT00527787|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
2799659|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 3|Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||points on a scale||Standard Deviation|Mean
2799616|NCT00527787|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
2799617|NCT00527787|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
2799618|NCT00527787|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat (ITT) Population|||Participants|||Number
2799619|NCT00527787|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population|||participants|||Number
2799620|NCT00527787|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population|||Participants|||Number
2799621|NCT00527787|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intention to Treat (ITT) Population|||Participants|||Number
2799622|NCT00527787|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population|||Participants|||Number
2799623|NCT00527787|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||Participants|||Number
2799624|NCT00527748|Primary|Change in Range of Motion|Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.|Ten weeks|No participant data or results are available as the investigator left the institution without making them or any analysis available.||||||
2799625|NCT00527735|Secondary|Overall Survival in Participants With SCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
2799626|NCT00527735|Secondary|Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.|||Participants|||Number
2799627|NCT00527735|Secondary|Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.|||Participants|||Number
2799793|NCT00526591|Primary|Toxicity Profile of Each Dose (Number of Patients With Worst Grade Toxicity)|Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAEv3.0)|at daily dose for 8 weeks|intention to treat|||participants|||Number
2799628|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Mean
2799629|NCT00527735|Secondary|Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.|||Percentage of participants|||Number
2799630|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade|ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.|||Participants|||Number
2799631|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.|||Participants|||Number
2799632|NCT00527735|Secondary|Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.|||Participants|||Number
2799633|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.|||Participants|||Number
2799634|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Percentage of participants|||Number
2799635|NCT00527735|Secondary|Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Participants|||Number
2799644|NCT00527735|Secondary|Overall Survival in Participants With NSCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 26.5 months)|All NSCLC participants who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
2799636|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Participants|||Number
2799637|NCT00527735|Secondary|irPFS in Participants With SCLC Per irRC|IRC performed TA.|Randomization date to date of irPD or death (maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Mean
2799638|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Percentage of participants|||Number
2799639|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.|||Participants|||Number
2799640|NCT00527735|Secondary|Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC|irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.|Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)|All participants who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
2799641|NCT00527735|Secondary|Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC|irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)|All participants who were randomized to a treatment group.|||Percent of participants||95% Confidence Interval|Number
2799642|NCT00527735|Secondary|Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)|irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.|||Percentage of participants||95% Confidence Interval|Number
2799643|NCT00527735|Secondary|Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC|mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.|||Percentage of participants||95% Confidence Interval|Number
2799678|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 9|ITT (efficacy cohort)|||mm Hg||Standard Error|Mean
2799645|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)|All NSCLC participants who were randomized to a treatment group.|||Months||95% Confidence Interval|Mean
2799646|NCT00527735|Primary|Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)|irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)|All participants with NSCLC who were randomized to a treatment group.|||Months||95% Confidence Interval|Median
2799647|NCT00527722|Primary|Number of Participants With Absence of Pneumothoraces|Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).|X-Rays at 0-60 minutes, 24 hours and 30 days|Intent-to-treat (ITT) population of all subjects who were randomized.|||Participants|||Number
2799648|NCT00527644|Secondary|Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security.||By post op day one HIDA scan.|Data not collected.||||||
2799649|NCT00527644|Primary|No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.||By post op day one HIDA scan.||||Participants|||Count of Participants
2799650|NCT00527618|Secondary|Sub-Study: To Evaluate the Kinetics of Plasma HIV-1 Decline Over the First Three Days of High-dose Valacyclovir Administration.|Plasma HIV-1 RNA was measured one day prior to, at initiation, and at 6, 24, 48, and 72 hours after initiating valacyclovir. Measurements at 24, 48, and 72 hours were used to determine the rate of HIV-1 RNA decline.|72 hours|In April 2010, we invited participants, including those who already completed the study, to participate in the substudy. Two participants had plasma HIV-1 RNA <40 copies/mL at the time of valacyclovir initiation and were excluded from analysis.|||log10 copies/mL/day||95% Confidence Interval|Mean
2799651|NCT00527618|Secondary|The Effect of Valacyclovir 1 g Twice Daily Compared With Acyclovir 400 mg Twice Daily on the Quantity of Genital HSV Detected During Shedding Episodes.|HSV DNA was quantitated from daily self-collected genital swabs for the four weeks of each drug intervention. The quantity of genital HSV DNA present, when HSV DNA was detected, was compared.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.|||log10 copies/mL||Full Range|Median
2799652|NCT00527618|Secondary|The Effect of Valacyclovir 1 Gram Twice Daily Compared to Acyclovir 400 mg Twice Daily on the Percentage of Days With Genital Herpes Lesions.|The percentage of days with genital herpes lesions was determined by the combined diary days in which genital lesions were recorded divided by the combined number of diary days for participants in the first four weeks of each drug intervention, multiplied by 100.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.|||percentage of days with genital lesions|||Number
2799653|NCT00527618|Primary|The Genital HSV Shedding Rate While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|HSV DNA quantitated from daily self-collected genital swabs for the first four weeks of each drug intervention. The shedding rate was determined by the combined number of swabs with HSV detected divided by the combined number of swabs collected from participants, multiplied by 100.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.|||percentage of swabs collected with HSV|||Number
2799654|NCT00527618|Primary|The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|Weekly measurements of plasma HIV-1 RNA on each drug were compared. The primary analysis was of the average difference in plasma HIV-1 RNA on valacyclovir and acyclovir as determined by a linear mixed model. The median of the average per-participant plasma HIV-1 RNA levels on valacyclovir and valacyclovir is also listed.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants. 27 participants had plasma HIV-1 RNA levels available for analysis, since samples for one participant were persistently inhibited.|||log10 copies/mL||Full Range|Median
2799655|NCT00527605|Secondary|Change From Baseline in Qmax at Month 3|Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||ml/s||Standard Deviation|Mean
2799656|NCT00527605|Secondary|Change From Baseline in Qmax at Month 6|Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||milliliters/second (ml/s)||Standard Deviation|Mean
2799657|NCT00527605|Secondary|Percent Change From Baseline in Qmax at Month 3|Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change||Standard Deviation|Mean
2799722|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength||4 weeks||||participants|||Number
2799660|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 6|Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||points on a scale||Standard Deviation|Mean
2799661|NCT00527605|Secondary|Percent Change From Baseline in the AUA-SI Score at Month 3|Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change||Standard Deviation|Mean
2799662|NCT00527605|Secondary|Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6|Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||percent change||Standard Deviation|Mean
2799663|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 3|Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||pg/ml||Standard Deviation|Mean
2799664|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 6|Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||picograms/milliliter (pg/ml)||Standard Deviation|Mean
2799665|NCT00527605|Secondary|Percent Change From Baseline in the Serum DHT at Month 3|Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change||Standard Deviation|Mean
2799666|NCT00527605|Secondary|Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6|Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||percent change||Standard Deviation|Mean
2799667|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 3|Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||cubic centimeters||Standard Deviation|Mean
2799668|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 6|Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.|||cubic centimeters||Standard Deviation|Mean
2799669|NCT00527605|Secondary|Percent Change From Baseline in the Prostate Volume at Month 3|Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.|||percent change in volume||Standard Deviation|Mean
2799670|NCT00527605|Primary|Percent Change From Baseline in the Prostate Volume at Month 6|Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.|||percent change in volume||Standard Deviation|Mean
2799671|NCT00527592|Primary|Comfort Immediately After Dosing|Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.|5 seconds|Intent to treat: All patients who received test article and completed the trial.|||Units on a scale|Participants|Standard Deviation|Mean
2799672|NCT00527566|Secondary|Efficacy- Exacerbation Rate|Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.|Treatment period (12 weeks)||||Exacerbation rate (Exacerbations/day)|||Number
2799673|NCT00527566|Primary|Number of Participants Who Experienced Specific Symptoms|Number of participants who experienced specific symptoms during the trial.|44 weeks||||Participants|||Number
2799674|NCT00527566|Secondary|Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims|The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.|20 weeks||||units on a scale||Full Range|Mean
2799675|NCT00527566|Secondary|Steroid Dosing During Trial||20 weeks||||Prednisone mg/day||Full Range|Mean
2799676|NCT00527566|Primary|Number of Participants With Indicated Side Effects|Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.|Participants were followed for the duration of the study, approximately 44 weeks||||Participants|||Number
2799677|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end end of week 12|ITT (efficacy cohort)|||mm Hg||Standard Error|Mean
2799679|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 6|ITT (efficacy cohort)|||mm Hg||Standard Error|Mean
2799680|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 3|ITT (efficacy cohort)|||mm Hg||Standard Deviation|Mean
2799681|NCT00527514|Secondary|Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure||Baseline to 12 weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.|||mm Hg||Standard Deviation|Mean
2799682|NCT00527514|Primary|Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring||Baseline to 12 Weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.|||mm Hg||Standard Deviation|Mean
2799683|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Tmax|The time for maximal concentration (tmax) was determined for data up to Day 42|Day 0-42||||Days||Standard Deviation|Mean
2799684|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Cmax|Cmax was determined for concentration measurements up to Day 42|Day 0-42||||ng/mL||Standard Deviation|Mean
2799685|NCT00527488|Primary|Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction|The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from 'No sexual activity' to 'Almost always to always'. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.|Day 0-42||||Units on a scale||Standard Deviation|Mean
2799686|NCT00527488|Primary|IPSS Global Quality of Life|"Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from delighted to terrible or 0 to 6."|Day 0-42||||Units on a scale||Standard Deviation|Mean
2799687|NCT00527488|Primary|International Prostate Specific Symptom (IPSS) Score|The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).|Day 0-42||||Units on a scale||Standard Deviation|Mean
2799688|NCT00527488|Primary|Post-void Residual Urine Volume|The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.|Day 0-42||||mL||Full Range|Mean
2799689|NCT00527488|Primary|Maximal Urinary Flow|Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.|Day 0-42||||mL/s||Standard Deviation|Mean
2799690|NCT00527488|Primary|Prostate Volume|The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.|Day 0-42||||mL||Standard Deviation|Mean
2799691|NCT00527488|Primary|Prostate Specific Antigen (PSA) Concentration||Day 0-42||||ng/mL||Standard Deviation|Mean
2799692|NCT00527488|Primary|Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration|The baseline interval concentration is 0.75 x baseline concentration|Day 0-42||||participants|||Number
2799693|NCT00527488|Primary|Number of Subjects With Testosterone Concentration ≤0.5 ng/mL||Day 0-42||||participants|||Number
2799694|NCT00527488|Primary|Duration of Testosterone Concentration Below 0.5 ng/mL|The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level|Day 0-42||||Days||Full Range|Median
2799695|NCT00527488|Primary|Time of Minimal Value of Testosterone (Tnadir)|The time point when the lowest testosterone concentration was measured|Day 0-42||||Days||Standard Deviation|Mean
2799696|NCT00527488|Primary|Minimal Value of Testosterone (Cnadir)|The lowest concentration of testosterone measured within the time frame|Day 0-42||||ng/mL||Standard Deviation|Mean
2799697|NCT00527488|Primary|Time of Testosterone Concentration Below Baseline Interval|The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit|Day 0-42||||Days||Standard Deviation|Mean
2799698|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: AUCt|Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42|0-42 Days||||ng*day/mL||Standard Deviation|Mean
2799699|NCT00527488|Primary|Testosterone Area Below Baseline Interval|The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)|0-42 Days||||ng*days/mL||Standard Deviation|Mean
2799700|NCT00527475|Secondary|The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months.||1 year|||||||
2799701|NCT00527475|Primary|The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.||1 year|Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events.|||percentage of participants|||Number
2799723|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass||4 weeks||||participants|||Number
2799702|NCT00527423|Secondary|Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline of original study to Wk 156||||letters read||Standard Deviation|Mean
2799703|NCT00527423|Secondary|Frequency (Number of Injections)|Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).|Baseline of this study to Wk 152|A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.|||Injections||Full Range|Median
2799704|NCT00527423|Primary|Number of Participants With Adverse Events (AE)|Number of participants with AEs summarized by category|Baseline of this study to Wk 152||||participants|||Number
2799705|NCT00527397|Primary|Self-Monitoring Blood Glucose Levels: Change From Baseline|Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.|One year|This endopoint was not analyzed because of small numbers of subjects due to early termination|||milligram/millilitre||Standard Deviation|Mean
2799706|NCT00527397|Secondary|Insulin Antibody Levels : Change From Baseline|Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||microunit/milliliter||Standard Deviation|Mean
2799707|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.|||liter/liter||Standard Deviation|Mean
2799708|NCT00527397|Secondary|The Values of Forced Vital Capacity:Change From Baseline|pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.|||liter||Standard Deviation|Mean
2799709|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Beseline, Week 1, Week 2, Week 6, Week 12, Week 26|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.|||liter||Standard Deviation|Mean
2799710|NCT00527397|Secondary|The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin|Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44|0 month to 12 months|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||events / subject-month|||Number
2799711|NCT00527397|Secondary|The Value of Fasting Plasma Glucose:Change From Baseline|Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||milligram/millilitre||Standard Deviation|Mean
2799712|NCT00527397|Secondary|The Values of Hemoglobin A1c:Change From Baseline|Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||percent||Standard Deviation|Mean
2799713|NCT00527397|Secondary|Daily Inhaled Insulin Dose|The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Up to 26 weeks|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.|||milligram||Standard Deviation|Mean
2799714|NCT00527332|Secondary|Health-related Economy.||Within 6 months after the surgery|||||||
2799715|NCT00527332|Secondary|The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.||Within 6 months after the surgery|||||||
2799716|NCT00527332|Secondary|Sick Leave.||Within 6 months after the surgery|||||||
2799717|NCT00527332|Secondary|Quality of Life and QALYs (Quality Adjusted Life Years).||Within 6 months after the surgery|||||||
2799718|NCT00527332|Secondary|Complications and Complication Rates.||Within 6 months after the surgery|||||||
2799719|NCT00527332|Secondary|Postoperative Consumption of Analgesics and Antiemetics.||Within 6 months after surgery|||||||
2799720|NCT00527332|Secondary|Occurrence and Degree of Postoperative Symptoms.||Within 6 months after the surgery|||||||
2799721|NCT00527332|Primary|Duration of Hospital Stay.|Duration of hospital stay defined as time from start anesthesia to leaving the hospital|Within 6 months after surgery|Participants who completed the study were analyzed|||Hours||Full Range|Median
2799725|NCT00527124|Secondary|Time to Progression|Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.|The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks||||months||95% Confidence Interval|Median
2799726|NCT00527124|Secondary|Overall Response Rate Evaluated by the RECIST Criteria|"The overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table.~Target Lesions CR CR PR SD PD Any Any Any~PSA Response CR PR PR Non-PD Any Any PD Any~Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any~New Lesions No No No No Yes or No Yes or No Yes or No Yes~Overall Response CR PR PR SD PD PD PD PD"|Up to 52 weeks||||proportion of evaluable patients||95% Confidence Interval|Number
2799727|NCT00527124|Secondary|Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group|PSA < 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed .|Up to 52 weeks||||proportion of evaluable patients||95% Confidence Interval|Number
2799728|NCT00527124|Primary|6-month Progression-free Survival (PFS) Proportion|The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free|Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months|Per protocol. 30 subjects on Arm I and 28 subjects on Arm II accrued for analysis of the primary endpoint of 6 mths PFS proportion. PFS is obtainable on all 58 participants enrolled, however 1 subject enrolled on Arm I withdrew before receiving any treatment, hence cannot be included for AE analysis and reporting, AE results involve 29 subjects.|||percentage of patients||95% Confidence Interval|Number
2799729|NCT00527111|Secondary|KRAS Mutation Rate|Percentage of Participants with KRAS mutation.|5 years|ITT population with KRAS test|||percentage of participants with mutation|||Number
2799730|NCT00527111|Secondary|Recurrence-free Survival (RFS) Rate at 5 Years|RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.|5 years|ITT population|||probability of recurrence-free survival||95% Confidence Interval|Number
2799731|NCT00527111|Secondary|5- Year Overall Survival (OS) Rate|Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.|5 years|ITT population|||probability of overall survival||95% Confidence Interval|Number
2799732|NCT00527111|Secondary|To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|5 years|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2799733|NCT00527111|Primary|Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.|A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.|5 years|Post surgery population|||percentage of participants||95% Confidence Interval|Number
2799734|NCT00527098|Primary|Mortality||From hospital arrival up to an average of 3.5 weeks|Analysis was per protocol.|||participants|||Number
2799735|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26||Week 26|This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed.|||participants|||Number
2799736|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10|A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.|Week 10|Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit.|||participants|||Number
2799737|NCT00527072|Primary|Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)|Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).|Week 10|This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.|||participants|||Number
2799738|NCT00526994|Primary|Quality of Life, Mental Health Composite|Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|past 30 days||||units on a scale||95% Confidence Interval|Mean
2799739|NCT00526994|Secondary|Disability|days lost from housework|one year follow-up||||days||95% Confidence Interval|Mean
2799741|NCT00526994|Primary|Quality of Life, Physical Health Composite|Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|at one-year follow-up||||units on a scale||95% Confidence Interval|Mean
2799742|NCT00526890|Secondary|Selenium Level by Incidence of SAE|Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.|Pre-treatment and every week for 6 weeks prior to chemotherapy.|All treated and eligible patients|||ng/mL||Full Range|Median
2799743|NCT00526890|Secondary|Overall Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter|Patients treated with study therapy|||months||95% Confidence Interval|Median
2799744|NCT00526890|Secondary|Failure-free Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.|Patients treated with study therapy|||months||95% Confidence Interval|Median
2799745|NCT00526890|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 month post-treatment, then q 3 months x 4||||percentage of patients||95% Confidence Interval|Number
2799746|NCT00526890|Primary|Incidence of Grade 3-4 Myelosuppression||During study treatment, up to 6 weeks|Patients Treated with Study Therapy|||percentage of participants||95% Confidence Interval|Number
2799747|NCT00526890|Primary|Incidence of Grade 3-4 Pneumonitis||During study treatment, up to 6 weeks|Patients treated with study therapy|||percentage of participants||95% Confidence Interval|Number
2799748|NCT00526890|Primary|Incidence of Grade 3-4 Esophagitis||During study treatment, up to 6 weeks|Treated with Study Therapy|||percentage of participants||95% Confidence Interval|Number
2799749|NCT00526799|Secondary|Duration of Stable Disease|To determine duration of stable disease, in months|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely||||months||95% Confidence Interval|Median
2799750|NCT00526799|Secondary|Clinical Benefit|To determine the rate of clinical benefit defined as the percentage of patients experiencing an objective response or a CA125 response.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely||||percentage of particpants||95% Confidence Interval|Number
2799751|NCT00526799|Secondary|Progression-free Survival|To determine the progression-free survival of patients treated with Sorafenib plus Topotecan.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely||||months||95% Confidence Interval|Median
2799752|NCT00526799|Primary|Percentage of Participants With Response|"To assess response in patients with recurrent or resistant epithelial ovarian cancer treated with Sorafenib plus Topotecan. Reponse evaluated per RECIST criteria where:~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Disease assessments were conducted on the 8th week (Cycle 2, Week 4) and every eight weeks there after, until treatment discontinuation||||percentage of participants|||Number
2799753|NCT00526799|Primary|Maximum Tolerated Dose (MTD)|An initial 3 patients will be enrolled at dose level 1. If all 3 patients in dose level 1 complete the first cycle of therapy without a dose limiting toxicity (DLT), 3 patients will be enrolled at dose level 2. If 0 of 3 or 1 of 6 patients in dose level 2 experience a DLT, all subsequent patients will be enrolled in the Phase II cohort at dose level 2. If 2 of the first 3 or 2 of the total 6 patients experience DLT at dose level 2, then dose level 1 will be considered the MTD and used in the second phase.|Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.|Of the 16 patients enrolled in the phase I study, five were not evaluable for MTD determination due to intercurrent illnesses interfering with toxicity assessment or withdrawal and were replaced or excluded.|||mg/day|||Number
2799754|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points|Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (<LLN to 3000/mm^3 of blood plasma [bp]), mild; G 2 (<3000 to 2000/mm^3 of bp), moderate; G 3 (<2000 to 1000/mm^3 of bp), severe; G 4 (<1000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799789|NCT00526630|Primary|The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.|"Gait stride length is the distance between two consecutive steps in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27||||centimeters||Standard Deviation|Mean
2799959|NCT00525824|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment|Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799755|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points|Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (<LLN to 75000/mm^3 of blood plasma [bp]), mild; G 2 (<75000 to 50000/mm^3 of bp), moderate; G 3 (<50000 to 25000/mm^3 of bp), severe; G 4 (<25000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799756|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points|Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (<LLN to 1500/millimeters cubed [mm^3] of blood plasma [bp]), mild; G 2 (<1500 to 1000/mm^3 of bp), moderate; G 3 (<1000 to 500/mm^3 of bp), severe; G 4 (<500/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799757|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points|Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799758|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points|Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (<LLN to 10 g/dL), mild; G 2 (<10.0 to 8.0 g/dL), moderate; G 3 (<8.0 to 6.5 g/dL), severe; G 4 (<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799759|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points|Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; <LLN to 130 mmol/L), mild; G 2 (>150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799760|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points|Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; <LLN to 1.2 mg/dL), mild; G 2 (value not available; <1.2 to 0.9 mg/dL), moderate; G 3 (>3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799761|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; <LLN to 3.0 mmol/L), mild; G 2 (>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2821315|NCT00373685|Secondary|Change From Baseline Hb at Week 24||Baseline and Week 24 or ET|ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF)|||g/dL||Standard Error|Least Squares Mean
2799762|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points|Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; <LLN to 55 mg/dL), mild; G 2 (>160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799763|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points|Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799764|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points|Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (<LLN to 8.0 mg/dL; >ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799765|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points|Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799766|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points|Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799767|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799768|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799850|NCT00526110|Primary|Maximum Tolerated Dose (MTD)|MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT's) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).|28 days||||mg/m^2|||Number
2799769|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points|Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (<lower limit of normal [LLN] to 3 grams per deciliter [g/dL]), mild; G 2 (<3 to 2 g/dL), moderate; G 3 (<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants with data available at the specified time points were evaluated.|||participants|||Number
2799770|NCT00526669|Secondary|Number of Participants in the Indicated Categories for Best Overall Response (BOR)|Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population|||participants|||Number
2799771|NCT00526669|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.|From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)|ITT Population. Duration of response was estimated for only the subset of participants who had response. Duration of response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||95% Confidence Interval|Median
2799772|NCT00526669|Secondary|Time to Response|Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.|Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)|ITT Population. Time to response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||Inter-Quartile Range|Median
2799773|NCT00526669|Secondary|Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||Inter-Quartile Range|Median
2799774|NCT00526669|Secondary|Time to Progression (All Deaths Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||Inter-Quartile Range|Median
2799775|NCT00526669|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.|From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)|ITT Population. OS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||95% Confidence Interval|Median
2799776|NCT00526669|Secondary|PFS|PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||weeks||95% Confidence Interval|Median
2799790|NCT00526630|Secondary|The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks|Patients will have a mild to severe gait disturbance with score >1 on the motor subscale of the Unified Parkinson's disease rating scale (UPDRS) but without need for a continuous ambulatory aid such as walker or wheelchair (Hoehn & Yahr 2-3). The highest score possible for the UPDRS is 108 which indicates severe motor impairment. The lowest score for the UPDRS is 0 which indicates no motor impairment.|At week 12 and 27||||units on a scale||Standard Deviation|Mean
2799777|NCT00526669|Primary|Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)|5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.|From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.|||percentage of participants|||Number
2799778|NCT00526669|Primary|Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])|Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.|From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)|ITT Population|||percentage of participants|||Number
2799779|NCT00526669|Primary|Change From Start of Run-in Period in Biomarker Expression Levels at Day 0|Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.|evaluated at baseline and after 7 days of study treatment|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants contributing viable samples were analyzed. Different participants contributed samples for different biomarkers.|||ratio||Full Range|Median
2799780|NCT00526656|Secondary|Time to Progression|Time to progression will be measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression.|at 4 weeks post-surgery|Data not collected.||||||
2799781|NCT00526656|Secondary|Evaluate Treatment to Surgical Complication and Morbidity|Determine if surgical morbidity was increased from time of last dose to time of surgery is defined as the number of subjects with increase non-ileus related morbidity due to treatment drug during the 2 week rest period.|following surgery at 6 weeks|Participants who received treatment and surgery.|||Participants|||Count of Participants
2799782|NCT00526656|Primary|Pathologic Complete Response Rate of Sunitinib|"Number of participants who at the time of cystectomy, to have no evidence of tumor grossly and microscopically on routine Hematoxylin and Eosin stain (H&E) (pathologic complete response or P0) will be defined as responders. All cases will be defined as responders (P0) or non-responders based on the presence of residual tumor.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started."|at 6 weeks|Participants who completed treatment and surgery|||Participants|||Count of Participants
2799783|NCT00526630|Secondary|The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.|The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The range is from 0 to 100, with 100 indicating the best health status.|Week 12 and 27||||units on a scale||Standard Deviation|Mean
2799784|NCT00526630|Secondary|The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates excessive daytime sleepiness. Higher scores imply worse sleepiness.|Week 12 and 27||||units on a scale||Standard Deviation|Mean
2799785|NCT00526630|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.|MADRS is a questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60|Week 12 and 27||||units on a scale||Standard Deviation|Mean
2799786|NCT00526630|Secondary|Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.|FOGQ is a questionnaire that quantifies severity of gait and falls. It contains 16 items with a 0-4 severity scale for each, for a range of 0 (normal) to 64 (most severe impairment).|Week 12 and 27||||units on a scale||Standard Deviation|Mean
2799787|NCT00526630|Secondary|Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.|Freezing and shuffling are measures of ambulatory impairment.|Week 12 and 27||||hours||Standard Deviation|Mean
2799788|NCT00526630|Primary|The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.|"Gait velocity is a measure of distance over time in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27||||centimeters/second||Standard Deviation|Mean
2799794|NCT00526591|Primary|Proportion of Patients Who Are P0 (i.e., no Clinically Detectable Tumor in the Pathologic Specimen) at Surgery|Specimens are fixed in formalin for 24 hours.Specimens are the cut at 3 mm intervals perpendicular to the rectal surface and the sections are examined grossly and microscopically on routine Hematoxylin and Eosin stain (H&E) (pathologic complete response or P0) will be defined as responders.|After 8 weeks of therapy at the time of prostatectomy|Intention to treat|||participants|||Number
2799795|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799796|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799797|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799798|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799799|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799800|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799801|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799851|NCT00526097|Secondary|Change From Baseline for Chloride (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||mmol/L||Standard Deviation|Mean
2799960|NCT00525824|Secondary|Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment|Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799802|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799803|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799804|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR, or UH-VCIN . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799805|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or first occurrence of an MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Partcipants|||Number
2799806|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799807|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|"Adverse events were categorized as bleeding events if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the TIMI Study Group criteria as major, minor or other. Clinically Significant Bleeding was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization."|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug|||Percentage of Participants|||Number
2799808|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|"Adverse events were categorized as bleeding events if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization."|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug|||Percentage of Participants|||Number
2800033|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
2799809|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA|||Percentage of Participants|||Number
2799810|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with coronary arterial disease (CAD) or peripheral arterial disease (PAD) and no history of a stroke or transient ischemic attack (TIA)|||Percentage of Participants|||Number
2799811|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799812|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799813|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799814|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799815|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799816|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2821316|NCT00373685|Secondary|Hemoglobin (Hb) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed|||gram per deciliter (g/dL)||Standard Deviation|Mean
2799817|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799818|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799819|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799820|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799821|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799822|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Perentage of Participants|||Number
2799823|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|"Adverse events were categorized as bleeding events if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. Clinically Significant Bleeding was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization."|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2799852|NCT00526097|Secondary|Change From Baseline for Potassium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||mmol/L||Standard Deviation|Mean
2799824|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|"Adverse events were categorized as bleeding events if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization."|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2799825|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799826|NCT00526474|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intent to Treat (ITT) Population, defined as all participants who were randomly assigned to a treatment arm.|||Percentage of Participants|||Number
2799827|NCT00526331|Primary|Length of Hospital Stay (LOS) by Participant|Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.|From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)|Study terminated by sponsor without analysis due to technical reasons.|||days|||Number
2799828|NCT00526292|Primary|Treatment Efficacy as Defined by Complete or Partial Remission||3 Months following treatment||||participants|||Number
2799829|NCT00526227|Secondary|Adverse Events|A total of 62 Adverse Events were reported in 43 subjects.|1 Month||||participants|||Number
2799830|NCT00526227|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observation. Only descriptive statistics were presented, no comparative measure was analyzed. 21 24-hour digital Holter records were review. 140 Save to Disk Files was reviewed. No anomalies were found. The device performed as intended.|1 month||||participants|||Number
2799831|NCT00526227|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Secura device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|Seventy-nine subjects completed at least one-month (28 days)of follow-up post-implant and were included in the analysis. One subject died prior to the 1-month follow-up.|||Percentage of participants|||Number
2799832|NCT00526188|Secondary|Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points|Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and combined pre- and post- contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion characterization in the Standard of reference (SOR)|||Percentage points||95% Confidence Interval|Mean
2799833|NCT00526188|Secondary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points|The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set, with at least 1 lesion in the Standard of Reference (SOR).|||Percentage points||95% Confidence Interval|Mean
2799853|NCT00526097|Secondary|Change From Baseline for Sodium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||mmol/L||Standard Deviation|Mean
2799834|NCT00526188|Primary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points|Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and post-contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion in the Standard of Reference (SOR)|||Percentage points||95% Confidence Interval|Mean
2799835|NCT00526162|Secondary|System Performance Assessed by Technical Observations|Reported technical observations will be reviewed to determine if there are any device performance issues.|1 month follow-up||||number of Technical Observations|||Number
2799836|NCT00526162|Secondary|System Performance Assessed by Save to Disk Files|94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.|1 month follow-up||||number of Save to Disk files|||Number
2799837|NCT00526162|Secondary|System Performance Assessed by Holter Records|The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.|1 month follow-up||||number of Holter recordings|||Number
2799838|NCT00526162|Secondary|Adverse Events|Number of Adverse Events reported in the implanted subjects.|1 month||||number of adverse events|||Number
2799839|NCT00526162|Primary|Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.|Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.|||percentage of patients||97.5% Confidence Interval|Number
2799840|NCT00526123|Secondary|Reliability of the Catheter|Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.|35 Weeks|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had the study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of study visits||Standard Deviation|Mean
2799841|NCT00526123|Secondary|Primary Failure Rate|The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.|First dialysis session with study catheter|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had a study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of catheters|||Number
2799842|NCT00526123|Secondary|Frequency of Clinician Interventions for Catheter Malfunction and Infection|Average number of times clinician intervention was required for either catheter malfunction or infection|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||events||Standard Deviation|Mean
2799843|NCT00526123|Secondary|Average Number of Line Reversals Per Subject|Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||events||Standard Deviation|Mean
2799844|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|245 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of participants|||Number
2799845|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|60 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of participants|||Number
2799846|NCT00526123|Secondary|Inadequate Flow Rates Requiring Surgical/Radiological Intervention|Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.|35 weeks|Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized.|||events|||Number
2799847|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|30 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.|||percentage of participants|||Number
2799848|NCT00526110|Secondary|Median Overall Survival|Overall survival was defined as the time from the start of treatment until death or last follow-up. Kaplan-Meier curve was used to estimate overall survival.|Up to 30 months||||months||Full Range|Median
2799849|NCT00526110|Primary|Progression Free Survival|Progression Free Survival (PFS) defined as the time from the first study drug administration until the first day of radiological and/or symptomatic disease progression is documented, or the start of further anticancer therapy or death from any cause, whichever occurs first. Kaplan-Meier curve was used to estimate PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.|Assessed from baseline to 30 months||||months||95% Confidence Interval|Median
2799854|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Overall Score|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799855|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Satisfaction'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799856|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799857|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799858|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799859|NCT00526097|Secondary|Change From Baseline in the SF-36 Physical Component Scale (PCS)|The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799860|NCT00526097|Secondary|Change From Baseline in the SF-36 Mental Component Scale (MCS)|The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799861|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Mental Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799862|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'|The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799863|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Social Functioning'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799864|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Vitality'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799865|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'General Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799961|NCT00525824|Secondary|Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment|Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799866|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Bodily Pain'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799867|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799868|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Physical Functioning'|The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799869|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||Participants|||Number
2799870|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure|||Participants|||Number
2799871|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799872|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799873|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799874|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799875|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799876|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799877|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799910|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799878|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799879|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799880|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799881|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799882|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799883|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799884|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799885|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799886|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799887|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799911|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799888|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799889|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799890|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799891|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799892|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799893|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799894|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799895|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799896|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799897|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799898|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799899|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799900|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799901|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799902|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799903|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799904|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799905|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799906|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799907|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799908|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Score on a scale||Standard Error|Least Squares Mean
2799909|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799956|NCT00525824|Secondary|Percent Change in TC/HDL-C After 6 Weeks Combination Treatment|Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799912|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799913|NCT00526097|Secondary|Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799914|NCT00526097|Secondary|Number of Premature Withdrawals at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799915|NCT00526097|Secondary|Number of Premature Withdrawals at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799916|NCT00526097|Secondary|Number of Premature Withdrawals at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799917|NCT00526097|Secondary|Number of Premature Withdrawals at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799918|NCT00526097|Secondary|Number of Premature Withdrawals Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799919|NCT00526097|Secondary|Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799920|NCT00526097|Secondary|Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799921|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline||Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799922|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline||Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799923|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline||Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799924|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline||Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799925|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline||Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Participants|||Number
2799926|NCT00526097|Secondary|Time to the First SBM Following the First Dose of Study Medication (SM)|The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.|Time of first dose of SM up to 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||Hours||95% Confidence Interval|Median
2799927|NCT00526097|Secondary|Number of SBMs at Week 4|The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
2799928|NCT00526097|Secondary|Number of SBMs at Week 3|The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
2799957|NCT00525824|Secondary|Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment|Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799929|NCT00526097|Secondary|Number of SBMs at Week 2|The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
2799930|NCT00526097|Secondary|Number of SBMs at Week 1|The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
2799931|NCT00526097|Secondary|Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period|A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.|4 Weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||SBMs per week||Standard Error|Least Squares Mean
2799932|NCT00526097|Secondary|Number of CSBMs at Week 4|The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
2799933|NCT00526097|Secondary|Number of CSBMs at Week 3|The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
2799934|NCT00526097|Secondary|Number of CSBMs at Week 2|The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
2799935|NCT00526097|Secondary|Number of CSBMs at Week 1|The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
2799936|NCT00526097|Primary|Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period|"A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.~The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data."|4 Weeks|Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure|||CSBMs per week||Standard Error|Least Squares Mean
2799937|NCT00526071|Secondary|Pharmacokinetics Of Migalastat As Assessed By Plasma Concentration|The concentration of migalastat was evaluated in plasma following a dose of 250 mg and 500 mg. Blood samples were taken at trough (predose or Time 0; just prior to the third dose during a 3 day on, 4 days off dosing regimen) and at peak (3 hr postdose; after the third dose during a 3 day on, 4 days off dosing regimen) during the Day 1 (250 mg) and Month 2 (500 mg) visits. This outcome presents the lowest and highest concentrations of migalastat measured in any of the participants for predose and 3 hr postdose.|0 (predose on Day 1; start of DEP), 3 hr (postdose at Month 2; during DEP])|Safety Population: all participants who received at least 1 dose of study drug.|||nanograms/milliliter|||Number
2799938|NCT00526071|Secondary|Absolute Change From Baseline In α-Galactosidase A (α-Gal A) Activity In Leukocytes To Month 42|The activity of the α-Gal A enzyme was measured in leukocyte lysate by a validated fluorometric assay method, using 4-methylumbelliferone as a reference. The activity values obtained were normalized to protein (measured using a colorimetric assay). Baseline was defined as the last non-missing pre-treatment value for each participant in his or her respective preceding migalastat Phase 2 study. A negative change from Baseline indicates that α-Gal A activity decreased. α-Gal A activity levels are presented for Baseline and Month 42.|Baseline, Month 42|PD Population: all participants who received at least 1 dose of study drug and who had a baseline measurement and at least 1 postbaseline PD measure.|||nanomoles (nm)/hour (hr)/mg protein||Standard Deviation|Mean
2799939|NCT00526071|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through End of Study (EOS) or follow-up (for participants who did not enroll in Study AT1001-041) are presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through EOS (up to 56 months) or follow-up (28 days after EOS)|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2799940|NCT00526058|Secondary|Device Parameters|Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.|Analyzed at specific time points throughout the study from week 0 to week 24.|Data for all 18 subjects; regardless of treatment sequence|||flow rate (mL/min)||Standard Deviation|Mean
2799941|NCT00526058|Secondary|Clinical Lab Profiles (Pre- and Post-Treatment)|Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.|Analyzed at specific time points throughout the study from week 0 to week 24.|Data for all 18 subjects; regardless of treatment sequence|||percent change||90% Confidence Interval|Mean
2799942|NCT00526058|Primary|Percent Change of the Pre and Post Treatment Value|The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.|Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.||||percent change||Standard Deviation|Mean
2799943|NCT00526058|Primary|Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.||Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..||||percent change||90% Confidence Interval|Mean
2799944|NCT00525915|Primary|Pathologic Complete Response Rate|Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.|Surgery post chemotherapy (approximately 10-11 weeks)|Participants who had surgery were reported for the pathCR rate assessment in this outcome.|||percentage of participants|||Number
2799945|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|50 Weeks|Participants characterized as clinical responders at 10 weeks were allowed to continue in the study.|||participants|||Number
2799946|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|10 weeks||||participants|||Number
2799947|NCT00525876|Primary|Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)|Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.|100 days post transplant|Analysis was per protocol.|||participants|||Number
2799948|NCT00525837|Secondary|Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)|"Reference:~Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients)."|6-8 weeks||||units on a scale||Standard Deviation|Mean
2799949|NCT00525837|Secondary|Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)|"Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a normal score, while an abnormal score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the disagree responses score one point, and either of the agree responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach's alpha of 0.94) (Franken et al, 2007)"|6-8 weeks||||score on a scale||Standard Error|Mean
2799950|NCT00525837|Primary|Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report|"this is a 16-item self report questionnaire that measures depressive symptoms.~Improvement is reported in change in depressive score~score ranges from 0-27, with higher numbers indicating more severe symptom reporting.~change is calculated by baseline plus/minus the value at the later time point"|Baseline and every 2 weeks until 8 weeks or study endpoint||||Units on a scale||95% Confidence Interval|Mean
2799951|NCT00525824|Secondary|Percent Change in LDL-C After 6 Weeks Monotherapy|Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799952|NCT00525824|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment|Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Full Range|Mean
2799953|NCT00525824|Secondary|Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment|Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799954|NCT00525824|Secondary|Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799955|NCT00525824|Secondary|Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799962|NCT00525824|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment|Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799963|NCT00525824|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment|Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)||||Percentage||Standard Deviation|Mean
2799964|NCT00525798|Secondary|Number of Patients With Non-vertebral Fractures|"The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.~Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained."|From baseline to month 36|all randomized patients|||Participants|||Number
2799965|NCT00525798|Primary|Number of Patients With New Vertebral Fractures|"The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).~The outcome is the number of new vertebral fractures from baseline to 36 months."|From baseline to month 36|all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.|||Participants|||Number
2799966|NCT00525785|Primary|Complete Pathologic Response Rate|"The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate.~Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both."|Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment||||percentage of participants||95% Confidence Interval|Number
2799967|NCT00525733|Primary|The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.||48 weeks||||# subjects without detectable viremia|||Number
2799968|NCT00525629|Primary|Insulin Resistance|HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.|4 days||||HOMA-IR index||Standard Deviation|Mean
2799969|NCT00525603|Primary|Overall Participant Response|Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Evaluated after 3 courses of 4 week therapy (12 weeks)|Sixty participants were analyzed for response. Four participants did not have a response and one participant was not evaluable.|||Participants|||Number
2799970|NCT00525590|Secondary|Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain)|Neurocognitive decline was defined as any decrease in NF scores less than (<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain.|Months 2, 4, 6, 9 and 12|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||percentage of participants|||Number
2799971|NCT00525590|Secondary|Time to Neurocognitive Deterioration|The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method.|Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||months||95% Confidence Interval|Number
2799972|NCT00525590|Secondary|Percentage of Participants With Neurologic Death|Neurologic Death was defined as death due to progression of neurologic disease.|Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||percentage of participants|||Number
2800000|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks||||units on scale||Standard Error|Mean
2800001|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks||||units on scale||Standard Error|Mean
2799973|NCT00525590|Secondary|Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores|The correlation between recurrence (local, distant or overall) & NF was assessed by presenting change in NF domain scores (memory domain [MD], executive function domain [EFD], fine motor coordination domain [FMCD]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second & third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted &education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains.|Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||z-score||Standard Deviation|Mean
2799974|NCT00525590|Secondary|Correlation of Tumor Recurrence With Residual Mass Effect||Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)|PP1 population. Since only two participants had residual tumor mass, no correlation analyses were performed for recurrence and residual mass effect.||||||
2799975|NCT00525590|Secondary|Time to Recurrence (Local, Distant and Overall)||Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||months||95% Confidence Interval|Median
2799976|NCT00525590|Secondary|Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence)||Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||percentage of participants|||Number
2799977|NCT00525590|Primary|Number of Participants With Neurocognitive Domains Preserved at Month 12|Preservation of NF was defined as a decrease of less than or equal to (<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).|Month 12|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||Participants|||Count of Participants
2799978|NCT00525590|Primary|Number of Participants With Neurocognitive Domains Preserved at Month 9|Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).|Month 9|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||Participants|||Count of Participants
2799979|NCT00525590|Primary|Number of Participants With Neurocognitive Domains Preserved at Month 6|Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).|Month 6|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||Participants|||Count of Participants
2799980|NCT00525590|Primary|Number of Participants With Neurocognitive Domains Preserved at Month 4|Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).|Month 4|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||Participants|||Count of Participants
2799981|NCT00525590|Primary|Number of Participants With Neurocognitive Domains Preserved at Month 2|Preservation of NF was defined as a decrease of <=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).|Month 2|The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.|||Participants|||Count of Participants
2800002|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks||||units on scale||Standard Error|Mean
2800003|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks||||units on scale||Standard Error|Mean
2800004|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks||||units on scale||Standard Error|Mean
2800005|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks||||units on scale||Standard Error|Mean
2799982|NCT00525590|Primary|Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12|NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by >=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method.|Month 12|The per protocol 1 (PP1) population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example whole brain radiation therapy [WBRT]) before recurrence.|||percentage of participants||95% Confidence Interval|Number
2799983|NCT00525525|Primary|Unexpected Toxicities During First 2 Cycles of Study Drug|Unexpected severe study-related adverse events|Within 8 weeks of initiating study therapy||||Events|||Number
2799984|NCT00525525|Secondary|Progression-free Survival|Progression-free survival was defined from the date of diagnosis to the date that progressive disease was first observed on imaging, or the date at which nonreversible neurologic progression or permanently increased corticosteroid requirement, death from any cause, or early discontinuation of treatment. Imaging guidelines were used to evaluate progression: (i) 25% increase in the sum of products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline; (ii) clear worsening of any assessable disease; (iii) appearance of any new lesion/site; and (iv) clear clinical worsening or failure to return for evaluation as a result of death or deteriorating condition (unless clearly unrelated to this cancer).|Approximately 6 months to 1 year||||months||95% Confidence Interval|Median
2799985|NCT00525525|Primary|Overall Survival (OS)|Overall survival was defined from the date of diagnosis to date of death from any cause|Approximately 6-24 months||||months||95% Confidence Interval|Median
2799986|NCT00525512|Secondary|Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status|Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|From first drug administration until 30 days after last drug administration||||participants|||Number
2799987|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
2799988|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
2799989|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
2799990|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks||||units on scale||Standard Error|Least Squares Mean
2799991|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 100 weeks||||liters||Standard Error|Least Squares Mean
2799992|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 100 weeks||||liters||Standard Error|Least Squares Mean
2799993|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 100 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2799994|NCT00525512|Secondary|Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase|COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.|baseline, 96 weeks||||participants|||Number
2799995|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
2799996|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
2799997|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
2799998|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
2799999|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks||||units on scale||Standard Error|Mean
2800007|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks||||units on scale||Standard Error|Mean
2800008|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks||||units on scale||Standard Error|Mean
2800009|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks||||units on scale||Standard Error|Mean
2800010|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks||||units on scale||Standard Error|Mean
2800011|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks||||units on scale||Standard Error|Mean
2800012|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks||||unit on scale||Standard Error|Mean
2800013|NCT00525512|Secondary|Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks||||unit on scale||Standard Error|Least Squares Mean
2800014|NCT00525512|Secondary|Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks||||unit on scale||Standard Error|Least Squares Mean
2800015|NCT00525512|Secondary|Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks||||units on scale||Standard Error|Least Squares Mean
2800016|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
2800017|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
2800018|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
2800019|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
2800020|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
2800021|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
2800022|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
2800023|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
2800024|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
2800025|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
2800026|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks||||liters||Standard Error|Least Squares Mean
2800027|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks||||liters||Standard Error|Least Squares Mean
2800028|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks||||liters||Standard Error|Least Squares Mean
2800029|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks||||liters||Standard Error|Least Squares Mean
2800030|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks||||liters||Standard Error|Least Squares Mean
2800031|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks||||liters||Standard Error|Least Squares Mean
2800032|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks||||liters||Standard Error|Least Squares Mean
2821441|NCT00372775|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of those surviving at end of 1 year from the first dose of study treatment.|Year 1|ITT|||Percentage of participants|||Number
2800045|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 64 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2800046|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 48 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2800047|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 32 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2800048|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 16 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2800049|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 8 weeks||||seconds||95% Confidence Interval|Least Squares Mean
2800050|NCT00525512|Primary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 96 weeks|Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data|||seconds||95% Confidence Interval|Least Squares Mean
2800051|NCT00525499|Secondary|Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12|"The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:~0 No acne lesions.~Rare non-inflammatory lesions.~Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.~Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.~Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.~Highly inflammatory lesions, multiple nodulo-cystic lesions."|Baseline to Week 12|ITT population: All randomized subjects|||Participants|||Number
2800052|NCT00525499|Primary|Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12|Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.|Baseline to Week 12|ITT population: All randomized subjects|||Percent change||Standard Deviation|Mean
2800053|NCT00525421|Secondary|Change in Serum C-reactive Protein and Serum Interleukin-6 Levels|Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).|2 weeks||||Percent change||Inter-Quartile Range|Median
2800054|NCT00525421|Primary|Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)|Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=>0-0.25 cm^2, 2= >0.25-1 cm^2, 3=>=1cm^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.|2 weeks||||percent change||Inter-Quartile Range|Median
2800055|NCT00525265|Primary|Body Weight|The body weight change from baseline at the time of final trial drug administration|Baseline, at the time of final trial drug administration||||Kg||Standard Deviation|Mean
2800056|NCT00525174|Secondary|Social Stigma From Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|24 weeks||||Units on a scale||Standard Deviation|Mean
2800057|NCT00525174|Secondary|Social Stigma From Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|6 weeks||||Units on a scale||Standard Deviation|Mean
2800058|NCT00525174|Secondary|Compliance With Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|24 weeks||||Units on a scale||Standard Deviation|Mean
2800059|NCT00525174|Secondary|Compliance With Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|6 weeks||||Units on a scale||Standard Deviation|Mean
2800060|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|24 weeks||||Units on a scale||Standard Deviation|Mean
2800061|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|6 weeks||||Units on a scale||Standard Deviation|Mean
2800062|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|24 weeks||||Units on a scale||Standard Deviation|Mean
2800063|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|6 weeks||||Units on a scale||Standard Deviation|Mean
2800064|NCT00525174|Secondary|Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||logMAR line||Standard Deviation|Mean
2800065|NCT00525174|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||participants|||Number
2800066|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks||||participants|||Number
2800067|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks||||participants|||Number
2800068|NCT00525174|Secondary|Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||logMAR line||Standard Deviation|Mean
2800069|NCT00525174|Secondary|Distribution of Patient Characteristics at the 24-week Outcome Exam.|The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to <5 years old at the time of enrollment).|24 weeks||||participants|||Number
2800082|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Incidence of Specified Adverse Events.|Safety of afatinib as indicated by incidence of specified adverse events: skin reactions (a preferred term of the system organ class: Skin and subcutaneous tissue disorders) and gastrointestinal (GI) (a system organ class).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set|||Percentage of participants|||Number
2800070|NCT00525174|Secondary|Distribution of Subjects With 3 or More Lines of Improvement|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||participants|||Number
2800071|NCT00525174|Secondary|Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks||||participants|||Number
2800072|NCT00525174|Secondary|Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks||||participants|||Number
2800073|NCT00525174|Secondary|Mean Interocular Difference at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks||||logMAR line||Standard Deviation|Mean
2800074|NCT00525174|Primary|Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks||||logMAR line||Standard Deviation|Mean
2800075|NCT00525174|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline.|Baseline to 24 weeks||||participants|||Number
2800076|NCT00525174|Primary|Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks||||logMAR||Standard Deviation|Mean
2800077|NCT00525174|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks||||participants|||Number
2800078|NCT00525161|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.|24 weeks||||percentage of participants||95% Confidence Interval|Number
2800079|NCT00525161|Secondary|Time to Progression||continuously||||months||95% Confidence Interval|Median
2800080|NCT00525161|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.|12 weeks after treatment & 8 weeks after initial documentation of response|one discontinued treatment after 2 weeks owing to a grade 3 rash and was not evaluable for response|||participants|||Number
2800081|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0|Safety of afatinib as indicated by intensity and incidence of worst adverse events graded according to National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) Version 3.0 (R04-0474).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set|||Percentage of participants|||Number
2800083|NCT00525148|Secondary|Cpre,ss,29|Predose concentration of the analyte in plasma at steady state immediately before administration of the 29th dose (Cpre,ss,29).|-0:05h (pre-dose) on Day 29|Treated Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2800084|NCT00525148|Secondary|Overall Survival Time|Overall survival time (OS) was also evaluated and was defined as the duration of time from start of treatment to time of death up to 93 months, regardless of the cause of death. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood's standard error estimate.|Start of treatment to time to all death, up to 93 months|Treated set|||Months||95% Confidence Interval|Median
2800085|NCT00525148|Secondary|Progression-free Survival|Progression-free survival (PFS) as per independent review was defined as the duration of time from the start of treatment until the day of objective tumor progression was confirmed by tumor imaging (Progressive Disease according to RECIST 1.0) or death, whichever came first. Patients with unknown progression status or unknown date of progression were reviewed on a case-by-case basis. Patients known to be alive without progression at the end of the trial or the last follow-up visit were censored at the date of the last imaging when the patient was known to be alive and progression-free. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood's standard error estimate.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set|||Months||95% Confidence Interval|Median
2800086|NCT00525148|Secondary|Time to Objective Response|"Time to objective response was defined as the number of days from the start of treatment to the first recorded objective response. Patients who did not experience objective response during the study were censored at the time of treatment discontinuation.~The results are provided as the percentage of participants for this Outcome Measure."|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set|||Percentage of participants|||Number
2800087|NCT00525148|Secondary|Duration of Objective Response|Duration of objective response (OR) was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death (or date of censoring for PFS) was objectively documented as per independent review.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set including only patients with objective response.|||Weeks||Standard Deviation|Mean
2800088|NCT00525148|Secondary|Duration of Clinical Benefit|Duration of clinical benefit (disease control) as per independent review was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence of SD, PR or CR.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set|||weeks||Standard Deviation|Mean
2800089|NCT00525148|Secondary|Clinical Benefit as Determined by RECIST 1.0|Clinical benefit was evaluated according to RECIST 1.0 by independent review assessment. Patients whose best RECIST 1.0 assessment was stable disease (SD), partial response (PR), or complete response (CR) were considered to have derived a clinical benefit from treatment.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set|||Percentage of participants||95% Confidence Interval|Number
2800090|NCT00525148|Primary|Objective Response (OR) as Determined by RECIST 1.0|Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.|||percentage of participants||95% Confidence Interval|Number
2800091|NCT00525135|Secondary|Survival||up to 10 years post-study treatment|Due to early termination, participants were not followed for survival after the primary outcome timeframe||||||
2800092|NCT00525135|Primary|Decrease in Tumor Size|Number of participants with decreased tumor size after study treatment|Baseline, 16 weeks||||participants|||Number
2800093|NCT00525135|Secondary|Side Effects of Drugs Affecting Quality of Life|Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment|17 weeks||||participants|||Number
2800094|NCT00525135|Secondary|Increased Radioactive Iodine Uptake|Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy|Baseline, 10 weeks||||participants|||Number
2800095|NCT00525135|Primary|Decrease in Thyroglobulin Level|Number of participants with decreased thyroglobulin level after study treatment|Baseline, 16 weeks||||participants|||Number
2800096|NCT00525044|Secondary|Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation|"Assessment of Patients' Assessment of Effectiveness on a 5-point VRS (very good, good, neither good nor poor, not very good, not at all good) at pre-dose baseline and at the end-of-study evaluation"|Day 1 and Day 2|FAS|||percentage of participants|||Number
2800097|NCT00525044|Secondary|Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation|Assessment of redness of the pharyngeal mucosa by the investigator on a 5-point VRS (normal, slightly red, clearly red, very red, severe inflammation) at pre-dose baseline and at the end-of-study evaluation.|Day 1 and Day 2|"SAFETY Set, which included all patients~who were randomized,~who took at least one dose of trial medication."|||percentage of participants|||Number
2800098|NCT00525044|Secondary|Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge|"Pain intensity difference from pre-dose baseline (PID) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge.~Adjusted Mean (Standard Error) are presented for this outcome measure."|pre-dose baseline and 0.5, 1, 2 and 3 hours|FAS|||score on a scale||Standard Error|Least Squares Mean
2801832|NCT00513695|Secondary|Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels||At baseline, after week 12 of therapy, and prior to surgery|Data not collected||||||
2800099|NCT00525044|Secondary|Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge|"Pain intensity (PI) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge.~The patient rates the intensity of his sore throat condition on a 6-point rating scale [VRS(PI)-verbal rating scale (pain intensity)] before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain.~Adjusted Mean (Standard Error) are presented for this outcome measure."|0.5, 1, 2 and 3 hours|FAS|||score on a scale||Standard Error|Least Squares Mean
2800100|NCT00525044|Primary|Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline|The calculation will be based on the pain intensity (PI) assessment by the patient before and then at (pain intensity difference at 30 minutes (PID30)), (pain intensity difference at 60 minutes (PID60)), (pain intensity difference at 120 minutes (PID120)) and (pain intensity difference at 180 minutes (PID180)) after the 1st lozenge. Using the difference in PI from pre-dose baseline for each time point subsequent to dosing, the SPIDnorm will be calculated as SPIDnorm = (30*PID30 + 30*PID60 + 60*PID120 + 60*PID180)/(180*PI (baseline)) The patient rates the intensity of his sore throat pain on a 6-point Verbal Rating Scale (VRS) pain intensity (PI) before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain.|pre-dose baseline and 30, 60, 120, and 180 minutes|"Full Analysis Set (FAS): FAS, which included all patients~who were randomized,~who took at least the first lozenge,~who had PI data of baseline."|||ratio||Standard Error|Least Squares Mean
2800101|NCT00525031|Primary|Response to Neoadjuvant Therapy: Overall Clinical Responses|Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.|Evaluated after a total of 8 weeks of therapy before definitive surgery.||||Participants|||Count of Participants
2800102|NCT00525031|Primary|Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)|Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.|Evaluated after a total of 8 weeks of therapy before definitive surgery.||||Participants|||Count of Participants
2800103|NCT00524940|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.|GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.|21 days post-vaccination|The GMT were evaluated in the per-protocol Population|||Titer||95% Confidence Interval|Geometric Mean
2800104|NCT00524940|Primary|Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.|Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.|0-3 days post-vaccination and entire study duration|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.|||Participants|||Number
2800105|NCT00524771|Primary|Number of Participants With Arterial Thromboembolism (ATE)|Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months||||participants|||Number
2800106|NCT00524771|Primary|Number of Participants With Venous Thromboembolism (VTE)|Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months|Study participants that were not excluded due to protocol violations.|||participants|||Number
2800107|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
2800108|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
2800109|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
2800110|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months||||GMT ratio||95% Confidence Interval|Number
2800111|NCT00524680|Secondary|Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls|Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls|Baseline, at 1, 3 ,6 months|All treated and eligible patients|||participants|||Number
2800112|NCT00524680|Secondary|Toxicity|Number of treated patients that had serious adverse events.|Baseline, at 1, 3 and 6 months|All treated and eligible patients|||participants|||Number
2800113|NCT00524680|Secondary|Pattern of Response of Parathormone|Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients|||pg/mL||Standard Deviation|Mean
2800114|NCT00524680|Primary|Pattern of Response of Serum 25(OH) D3 Levels|Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients|||ng/mL||Standard Deviation|Mean
2800115|NCT00524589|Secondary|Corrected Serum Calcium Expression|Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.|1 year|All treated and eligible patients|||Participants|||Count of Participants
2800116|NCT00524589|Primary|Objective Response (Complete or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|All treated and eligible patients|||percentage of participants|||Number
2800117|NCT00524576|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. This table describes SAEs reported by all subjects except for those enrolled in the Australian center.|||participants|||Number
2800118|NCT00524576|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
2800119|NCT00524576|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
2800120|NCT00524576|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
2800121|NCT00524576|Secondary|Concentration of Anti-HBs Antibodies|Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.|||mIU/mL||95% Confidence Interval|Geometric Mean
2800122|NCT00524576|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
2800123|NCT00524576|Primary|Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|"Immune response defined as:~For initially seronegative subjects (anti-HBs antibody concentration <3.3 milli-international unit per milliliter [mIU/mL] before vaccination) antibody concentration ≥ 10mIU/mL at post booster.~For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration."|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.|||participants|||Number
2800124|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital at given timepoint."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital."|||total days in hospital||Standard Deviation|Mean
2800125|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital and at least one admission to hospital at given timepoint.."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital and at least one admission to hospital."|||number of admissions to hospital||Standard Deviation|Mean
2800126|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at emergency room.|||number of visits at emergency room||Standard Deviation|Mean
2800151|NCT00524459|Secondary|Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy||Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2800127|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at physician's office.|||number of visits at physician's office||Standard Deviation|Mean
2800128|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit|Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of activity impairment||Standard Deviation|Mean
2800129|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit|The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of overall work impairment||Standard Deviation|Mean
2800130|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit|Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of impairment while working||Standard Deviation|Mean
2800131|NCT00524537|Secondary|Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit|Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.|||percentage of work time missed||Standard Deviation|Mean
2800132|NCT00524537|Secondary|Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit|The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with PGA measurements.|||units on a scale||Standard Deviation|Mean
2800133|NCT00524537|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with SIBDQ measurements.|||units on a scale||Standard Deviation|Mean
2800152|NCT00524459|Secondary|Overall Clinical Local Regional Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2800153|NCT00524459|Primary|Clinical Complete Response||Surgery done after completion of six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2800154|NCT00524459|Primary|Pathological Complete Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2827323|NCT00323037|Secondary|Change From Baseline in Left Ventricular Remodeling (IVST, PWT, LVM, ESV, EDV, EDVI, ESD, EDD, Deceleration Time, and E:A Ratio)||24 weeks after entry into the maintenance period|||||||
2800134|NCT00524537|Primary|Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~For more details on adverse events please see the AE section below."|Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).|All Treated Population: All participants who received at least 1 injection of Humira in the registry|||Participants|||Count of Participants
2800135|NCT00524511|Secondary|Patient Satisfaction of Cosmesis of Surgical Wound|survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)|before hospital discharge after surgery|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.||||||
2800136|NCT00524511|Primary|Wound Complication Rate|Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound|within six weeks of study intervention|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.||||||
2800137|NCT00524485|Secondary|Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800138|NCT00524485|Secondary|PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800139|NCT00524485|Secondary|Histological Response|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800140|NCT00524485|Secondary|Effects of Different Treatment Conditions on Efficacy|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800141|NCT00524485|Secondary|Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800142|NCT00524485|Primary|Extent That the PpIX is Photobleached by the Treatment Light|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800143|NCT00524485|Primary|Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site|||Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.||||||
2800144|NCT00524472|Secondary|a Composite of Minor Postoperative Complications|a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.|within 30 days after surgery||||Participants|||Count of Participants
2800145|NCT00524472|Secondary|All-cause Mortality|All-cause mortality identified during one-year follow-up.|one year post operative||||Participants|||Count of Participants
2800146|NCT00524472|Secondary|Duration of Intensive Care Stay|Hours from date of surgery to discharge from intensive care unit|ICU stay hours during hospital stay after surgery, on average of 25 hours||||hours||95% Confidence Interval|Median
2800147|NCT00524472|Secondary|Duration of Hospitalization|Days from date of surgery to hospital discharge|starting post operative day one to discharge from hospital, on an average of 8 days||||days||95% Confidence Interval|Median
2800148|NCT00524472|Secondary|Post Operative Atrial Fibrillation|Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery|15 - 30 days post operative||||Participants|||Count of Participants
2800149|NCT00524472|Primary|Any Major Morbidity/30-day Mortality|"a composite (any versus none) of the following major postoperative complications occurring:~all-cause postoperative mortality~failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation~serious postoperative infection~acute postoperative kidney injury requiring renal replacement therapy;~new postoperative focal or global neurologic deficit."|within 30 days post surgery||||Participants|||Count of Participants
2800150|NCT00524459|Secondary|Safety, in Terms of Neutropenia and Cardiac Toxicity||Every cycle during study treatment and 8 weeks post-treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2800155|NCT00524420|Secondary|Adverse Events|Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.|Measured daily||||number of adverse events|||Number
2800156|NCT00524420|Secondary|Hamilton Depression Rating Scale|The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.|Measured weekly||||units on a scale||Standard Deviation|Mean
2800157|NCT00524420|Secondary|Gracely Box Unpleasantness Scale|The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.|Measured weekly||||units on a scale||Standard Deviation|Mean
2800158|NCT00524420|Primary|Gracely Box Intensity Rating Scale|The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.|Measured weekly||||units on a scale||Standard Deviation|Mean
2800159|NCT00524394|Primary|Cytokines|IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .|O TO 30 DAYS OF LIFE|zero participant analyzed||||||
2800160|NCT00524394|Primary|Immunological Homeostasis|"Describe changes in immunological homeostasis that indicate the normal function vs. presence of sepsis in newborn infants of various gestational ages"|0 to 30 days of life.|||||||
2800161|NCT00524368|Secondary|Number of Participants Developing Mutations at Endpoint|Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||Participants|||Number
2800162|NCT00524368|Secondary|Predose Plasma Concentration (C0h) of DRV and Rtv.|Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
2800163|NCT00524368|Secondary|Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv|Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||ng*h/mL||Full Range|Median
2800164|NCT00524368|Secondary|Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48|Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.|||Percentage of participants|||Number
2800165|NCT00524368|Secondary|Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score|The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.|48 weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.|||Scores on a scale||Full Range|Median
2800166|NCT00524368|Secondary|Change in CD4+ Cell Count From Baseline|CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.|48 Weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.|||10e6/l||Full Range|Median
2800167|NCT00524368|Secondary|Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks||48 weeks|Intention To Treat (ITT) population: Observed cases|||log10 copies/mL||Standard Error|Least Squares Mean
2800168|NCT00524368|Secondary|Time to Loss of Virologic Response|Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Days||Standard Error|Mean
2800169|NCT00524368|Secondary|Time to Reach First Virologic Response|Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Days||Full Range|Median
2800170|NCT00524368|Secondary|Change in log10 Viral Load From Baseline at Week 48||48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||log10 copies/mL||Full Range|Median
2800171|NCT00524368|Secondary|Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)|Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Participants|||Number
2800172|NCT00524368|Primary|Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|48 Weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.|||Participants|||Number
2800173|NCT00524342|Secondary|No. of Subjects With IL-11 Associated Adverse Events.|The number of subjects with IL-11 associated adverse events.|The time frame is up to 7 months per subject.||||participants|||Number
2800174|NCT00524342|Secondary|No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).|No. of subjects with detectable VWFmRNA, a measure of IL-11 (interleukin-11) function, specifically increasing VWF synthesis.|The time frame is up to 7 months per subject.||||participants|||Number
2800175|NCT00524342|Primary|>50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months|Subjective estimate of blood loss was measured by using a Pictorial blood assessment chart (PBAC) . The PBAC measures scores on a scale where 0 to 100 is normal and greater than 100-200 are abnormal.|6 months||||percentage of participants|||Number
2800176|NCT00524316|Secondary|Tumor Marker Response (AFP)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, week 7 and every 6 weeks after|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2800177|NCT00524316|Secondary|Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers.|"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores reflect better quality of life.~No subscales were analyzed."|Baseline and Cycle 2|All treated and eligible patients|||units on a scale||Standard Deviation|Mean
2800178|NCT00524316|Secondary|Safety and Tolerability|"Number of participants with adverse advent.~Please refer to adverse event reporting for more detail."|Daily while on treatment through study completion, an average of 1 year|All treated and eligible patients|||participants|||Number
2800179|NCT00524316|Secondary|Tissue Perfusion, Ktrans, IAUC, and Percent Viable Tumor as Measured by DCE-MRI at Baseline and on Days 8 (Before Transarterial Chemoembolization), 10, and 35||Baseline, day 8, day 10, day 28 and day 35|Due to the study's early termination and inadequate number of patients, no data were collected for this Outcome Measure.||||||
2800180|NCT00524316|Secondary|Overall Survival|median survival in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|All treated and eligible patients|||months||95% Confidence Interval|Median
2800181|NCT00524316|Primary|Progression-free Survival|median progression free survival in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|All treated and eligible patients.|||months||95% Confidence Interval|Median
2800182|NCT00524303|Other Pre-specified|Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment|Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level.|Tumor core biopsy taken at Baseline and Treatment Day 14|||||||
2800183|NCT00524303|Other Pre-specified|Cancer Stem Cells and the Correlation to Response/Non-response to Treatment|Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed.|Tumor core biopsy taken at Baseline and Treatment Day 14|||||||
2800184|NCT00524303|Other Pre-specified|Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14|Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value.|Tumor core biopsy taken at Baseline and Treatment Day 14|ITT-E Population. Only those participants with matched pairs of biopsy samples for analysis at Baseline and on Day 14 were analyzed.|||: normalized relative expression level||Standard Deviation|Mean
2800229|NCT00524017|Secondary|Status of EGFR Pathway Components and Molecular Alterations in Post-treatment Biopsies||At 8 weeks post-treatment|Data was not collected for this outcome||||||
2800185|NCT00524303|Secondary|Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed.|Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course|Safety Population. Not all participants in the Safety Population were analyzed: some participants were randomized to an arm they did not want or participants were randomized in error (eligibility criteria weren’t met).|||participants|||Number
2800186|NCT00524303|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal|12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result.|Baseline and EOT (up to Week 26) or Early withdrawal|Safety Population: all randomized participants (par) who received at least one dose of investigational product, based on actual treatment received if this differed from that to which par was randomized. Not all par were analyzed: some par were randomized to an arm they did not want or par were randomized in error (eligibility criteria weren’t met).|||participants|||Number
2800187|NCT00524303|Secondary|Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization|Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal.|From first dose date until disease progression, assessed up to a maximum of 5 years|ITT Population|||Percentage||95% Confidence Interval|Number
2800188|NCT00524303|Secondary|Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal|cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Week 26 or EOT or Early withdrawal|ITT Population: all randomized participants regardless of whether they had received any treatment.|||percentage of participants|||Number
2800189|NCT00524303|Primary|Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy|A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.|Week 26|Intent-to-Treat-Evaluable (ITT-E) Population: ITT participants with evaluable tumor responses who had been >=75% compliant to 5-fluorouracil (5-FU) 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 (FEC75) and paclitaxel 80 mg/m^2 and had undergone surgery.|||percentage of participants|||Number
2800190|NCT00524264|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population|||Percentage of patients with ≥ 3 lines|||Number
2800191|NCT00524264|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population|||millimeters squared (mm²)||Standard Deviation|Mean
2800192|NCT00524264|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
2800193|NCT00524264|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
2800194|NCT00524225|Secondary|Number of Subjects Who Experienced Adverse Events|mild headache, nausea|The time frame is within 4 weeks of surgery.||||participants|||Number
2800195|NCT00524225|Secondary|No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).|The number of subjects with detectable VWFmRNA.|4 weeks per subject|Even though three subjects were enrolled, none were assessed for VWFmRNA because the study stopped due to poor enrollment related to insurers requiring surgeries outside of UPMC.||||||
2800196|NCT00524225|Primary|Volume of Blood Transfusion|The volume of blood transfusion required (units of blood) after the surgical procedure.|4 weeks||||units of blood|||Number
2800197|NCT00524225|Primary|Volume of Surgical Blood Loss|Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.|4 weeks||||cc|||Number
2800198|NCT00524173|Secondary|Number of Participants With Loss of HBsAg|The number of participants whose serum hepatitis B surface antigen was no longer detectable.|192 weeks|The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.|||Participants|||Count of Participants
2800199|NCT00524173|Secondary|Number of Participants With Normalized Alanine Aminotransferase (ALT)|Number of participants whose serum ALT levels were measured within normal limits.|192 weeks|The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.|||Participants|||Count of Participants
2800230|NCT00524017|Secondary|Status of Epidermal Growth Factor Receptor (EGFR) Pathway Components and Molecular Alterations in Pre-treatment Biopsies||Baseline (pre-treatment)|Data was not collected for this outcome||||||
2803627|NCT00498628|Secondary|Percent Days Abstinent|Timeline Follow-back drinking data is used to calculate the % of days abstinent per week during Weeks 3-11|Weeks 3-11||||percentage of days abstinent||Standard Error|Least Squares Mean
2800200|NCT00524173|Primary|Number of Participants With HBV DNA <1000 IU/ml at Week 192|Number of participants whose serum HBV DNA level was <1000 IU/ml at Week 192|At Week 192|The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.|||Participants|||Count of Participants
2800201|NCT00524173|Primary|Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48|Number of subjects whose serum HBV DNA level was <1000 IU/ml at Week 48|At Week 48|The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.|||Participants|||Count of Participants
2800202|NCT00524134|Secondary|Prevalence of Medication Retention/Treatment Failure||16 weeks|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
2800203|NCT00524134|Secondary|Prevalence of Seizure Freedom||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
2800204|NCT00524134|Secondary|Percent Change in Total Seizure Count Between Treatment Arms||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
2800205|NCT00524134|Primary|Proportion of Each Treatment Arm With ≥50% Reduction in Seizures||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.||||||
2800206|NCT00524121|Secondary|Response by EGFR Mutation Status||Radiologic evaluation every 3 months, up to 5 years||||participants|||Number
2800207|NCT00524121|Secondary|Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression||Radiologic evaluation every 3 months, up to 5 years||||participants|||Number
2800208|NCT00524121|Secondary|Response by Epidermal Growth Factor Receptor (EGFR) Expression||Radiologic evaluation every 3 months, up to 5 years||||participants|||Number
2800209|NCT00524121|Secondary|Correlation of Smoking Status With Overall Survival||5 years|Patients Treated with Study Therapy|||months||95% Confidence Interval|Median
2800210|NCT00524121|Secondary|Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale|Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes|Baseline and Week 3|Patients Treated with Study Therapy and with FACT-E scores available|||FACT-E Score||Full Range|Median
2800211|NCT00524121|Secondary|Progresssion-Free Survival|Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 3 months, up to 5 years||||months||95% Confidence Interval|Median
2800212|NCT00524121|Secondary|Complete Response|"Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation.~Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor."|4-8 weeks after completion of radiation.|Patients Treated with Study Therapy|||percentage of participants||95% Confidence Interval|Number
2800213|NCT00524121|Primary|Overall Survival||5 years||||months||95% Confidence Interval|Median
2800214|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score|The MOS SF-36 is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2800215|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score|The Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36) is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2801546|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2800216|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score|The Personal and Social Performance (PSP) scale assesses the degree of difficulty (ranging from i [absent] to vi [very severe]) a patient exhibits over a 1-month period in socially useful activities, personal and social relationships, self care, and disturbing and aggressive behavior. The overall score ranges from 1 to 100. Patients with scores of 71 to 100 have a mild degree of difficulty; patients with scores from 31 to 70 have various degrees of disability; and patients with scores of 30 or less function so poorly as to require intensive supervision.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2800217|NCT00524043|Secondary|Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S|The Clinical Global Impression-Severity (CGI-S) rating scale is used by psychiatrists to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). The scale permits a global evaluation of the patient's condition at a given time.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Full Range|Median
2800218|NCT00524043|Primary|Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).|The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2800219|NCT00524030|Secondary|Pregabalin Exposure-Response Analysis|Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates.|Day 126|MITT Full Study Set|||Percentage of Participants|||Number
2800220|NCT00524030|Secondary|Pregabalin Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Baseline up to 20 weeks|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.||||||
2800221|NCT00524030|Secondary|Percentage of Seizure-Free Participants by Study Phase|Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140)|Day 1 up to Day 140|MITT Full Study Set|||Percentage of Participants|||Number
2800222|NCT00524030|Secondary|Mean Time on Pregabalin Monotherapy||Week 2 to Week 20|MITT Full Study Set; N=number of participants entering Monotherapy Period|||Days||Standard Deviation|Mean
2800223|NCT00524030|Secondary|Percentage of Participants Who Met Protocol-Specified Exit Events|Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity|Week 2 up to Week 18|MITT Efficacy Set|||Percentage of Participants|||Number
2800224|NCT00524030|Secondary|Percentage of Participants Completing 20 Weeks of Double-Blind Treatment||Randomization up to Week 20|MITT Full Study Set|||Percentage of Participants|||Number
2800225|NCT00524030|Secondary|Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100%|Week 2 up to Week 18|MITT Full Study Set: all randomized participants who met the MITT definition (received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2)|||Percentage of Participants||95% Confidence Interval|Number
2800226|NCT00524030|Primary|Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%|Week 2 up to Week 18|Modified Intent to Treat (MITT) Efficacy Set: The first 125 participants randomized who received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2. Number of participants analyzed (N)= number of MITT participants with discontinuation/completion data.|||Percentage of Participants||95% Confidence Interval|Number
2800227|NCT00524017|Secondary|Lesion Recurrence||Up to year 5 years post-treatment|No patients were followed for this outcome measure||||||
2800228|NCT00524017|Secondary|Survival||Up to year 5 years post-treatment|No patients were followed for this outcome measure||||||
2800231|NCT00524017|Secondary|Number of Participants With Objective Response Based on Clinical Assessment|Clinical visualization on whether lesion responded to treatment (i.e., direct visualization of the lesion combined with histologic grade)|8 weeks||||Participants|||Count of Participants
2800232|NCT00524017|Primary|Number of Participants With Objective Response Based on Histologic Grade|Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).|8 weeks||||Participants|||Count of Participants
2800233|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 24)|Change from baseline in number of steps per day (week 24)|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
2800234|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 20)|Change from baseline in number of steps per day (week 20)|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
2800235|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 16)|Change from baseline in number of steps per day (week 16)|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
2800236|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 12)|Change from baseline in Number of steps per day (week 12)|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
2800237|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day(Week 8)|Change from baseline in number of steps per day (week 8)|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
2800238|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 4)|Change from baseline in number of steps per day (week 4)|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Error|Least Squares Mean
2800239|NCT00523991|Secondary|Number of Steps Per Day (Baseline)|Number of steps per day (baseline)|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Steps||Standard Deviation|Mean
2800240|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 24)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
2800241|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 20)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
2800242|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 16)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
2800243|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 12)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
2800244|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 8)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
2800245|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 4)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Error|Least Squares Mean
2800246|NCT00523991|Secondary|Active Energy Expenditure (Baseline)|The amount of energy (kcal/day) that a person uses while physically active.|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||kilo calories per day||Standard Deviation|Mean
2800247|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 24)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800248|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 20)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800249|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 16)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800250|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 12)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800251|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 8)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800252|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 4)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800253|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Baseline)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||Participants|||Number
2800254|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800255|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800256|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800257|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800258|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800259|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800260|NCT00523991|Secondary|Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Deviation|Mean
2800261|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800262|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800263|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800264|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity defined as less than three metabolic equivalents.~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800265|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800266|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Error|Least Squares Mean
2800306|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 8)|Difference in number of days that participants used albuterol prn per week between week 8 and baseline|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
2800267|NCT00523991|Secondary|Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents.~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm."|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days|||ln(minutes)||Standard Deviation|Mean
2800268|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800269|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800270|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800271|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800272|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800273|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800307|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 4)|Difference in number of days that participants used albuterol prn per week between week 4 and baseline|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
2800308|NCT00523991|Secondary|Albuterol Use p.r.n. (Baseline)|Number of days that participants used albuterol prn per week|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
2800274|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
2800275|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800276|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800277|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800278|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800279|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800280|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800309|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)|Change from baseline in forced vital capacity (week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2801547|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2800281|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
2800282|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800283|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800284|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800285|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800286|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800287|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800310|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)|Change from baseline in forced vital capacity (week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2801548|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2800288|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
2800289|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800290|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800291|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800292|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800293|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800294|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Error|Least Squares Mean
2800311|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)|Change from baseline in forced vital capacity (week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800578|NCT00521885|Primary|Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u|Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.|14 days|||||||
2800295|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||units on a scale||Standard Deviation|Mean
2800296|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)|"The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
2800297|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)|"The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
2800298|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)|"The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
2800299|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
2800300|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
2800301|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||Participants|||Number
2800302|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 24)|Difference in number of days that participants used albuterol prn per week between week 24 and baseline|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Error|Least Squares Mean
2800303|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 20)|Difference in number of days that participants used albuterol prn per week between week 20 and baseline|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
2800304|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 16)|Difference in number of days that participants used albuterol prn per week between week 16 and baseline|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
2800305|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 12)|Difference in number of days that participants used albuterol prn per week between week 12 and baseline|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||days||Standard Deviation|Mean
2800312|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)|Change from baseline in forced vital capacity (week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800313|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)|Change from baseline in forced vital capacity (week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800314|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)|Change from baseline in forced vital capacity (week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800315|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)|Change from baseline in forced vital capacity (week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800316|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)|Change from baseline in forced vital capacity (week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800317|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)|Change from baseline in forced vital capacity (week 16, 30 minutes)|baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800318|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)|Change from baseline in forced vital capacity (week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800319|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)|Change from baseline in forced vital capacity (week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800320|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)|Change from baseline in forced vital capacity (week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800321|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)|Change from baseline in forced vital capacity (week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800322|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)|Change from baseline in forced vital capacity (week 8, 30 minutes)|baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800323|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)|Change from baseline in forced vital capacity (week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800324|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 180 Minutes)|Forced vital capacity (baseline, 180 minutes)|baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800325|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 120 Minutes)|Forced vital capacity (baseline, 120 minutes)|baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800326|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 60 Minutes)|Forced vital capacity (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800327|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 30 Minutes)|Forced vital capacity (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800328|NCT00523991|Secondary|Forced Vital Capacity (Baseline, Pre-dose)|Forced vital capacity (baseline, pre-dose)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800329|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800330|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800331|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800332|NCT00523991|Secondary|Peak Forced Vital Capacity (FVC) (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800333|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 24)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800334|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 16)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800335|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 8)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800336|NCT00523991|Secondary|Trough Forced Vital Capacity (Baseline)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800337|NCT00523991|Secondary|FVC AUC0-3 at Week 24 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Error|Least Squares Mean
2800338|NCT00523991|Secondary|FVC AUC0-3 at Week 16 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Deviation|Mean
2800339|NCT00523991|Secondary|FVC AUC0-3 at Week 8 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Deviation|Mean
2800340|NCT00523991|Secondary|FVC AUC0-3 at Baseline|Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Deviation|Mean
2800341|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800342|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800343|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800344|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800345|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800346|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800347|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800348|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800349|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)|Baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800350|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800351|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800352|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800353|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800354|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)|Baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800355|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800356|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)|Forced expiratory volume in 1 second (baseline, 180 minutes)|Baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800357|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)|Forced expiratory volume in 1 second (baseline, 120 minutes)|Baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800358|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)|Forced expiratory volume in 1 second (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800359|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)|Forced expiratory volume in 1 second (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800360|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)|Forced expiratory volume in 1 second (baseline, pre-dose)|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800400|NCT00523705|Primary|Subject Daily Symptom Rating Score.|A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.|baseline and 5 months.||||units on a scale||Standard Deviation|Mean
2800401|NCT00523640|Secondary|Overall Survival|Time from enrollment until death from any cause.|60 months||||months||95% Confidence Interval|Median
2800361|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800362|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800363|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800364|NCT00523991|Secondary|Peak Forced Expiratory Volume in 1 Second (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800365|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Error|Least Squares Mean
2800366|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800367|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800368|NCT00523991|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres||Standard Deviation|Mean
2800369|NCT00523991|Primary|Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)|Change = Week 24 Value - Baseline Value|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint|||litres * hours||Standard Error|Least Squares Mean
2800370|NCT00523978|Primary|Cryoablation Procedure Events (CPEs)|Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.|To end of ablation procedure|Data for subjects who were randomized to the Experimental group and received cryoablation therapy were included in this analysis. All CPEs reported in the Experimental group were included in the analysis regardless of their association with the first or a repeat cryoablation.|||participants|||Number
2800371|NCT00523978|Primary|Freedom From Major Atrial Fibrillation Events (MAFEs)|Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.|12 Months|mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment.|||participants|||Number
2800372|NCT00523978|Primary|Treatment Success|Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.|12 months|The mITT population consisted of all subjects, who were enrolled, randomized and received treatment|||participants|||Number
2800402|NCT00523640|Primary|Progression-free Survival|Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline|60 months||||months||95% Confidence Interval|Median
2800403|NCT00523640|Primary|Objective Response Rate|Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.|12 weeks||||proportion|||Number
2800373|NCT00523978|Primary|Freedom From Chronic Treatment Failure (CTF)|Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|12 month follow up period|This section includes data for subjects who were randomized, received treatment and were followed through 12-Months post randomized treatment regardless of AF Drug usage. Subjects who experienced Acute Procedural Failure in the Experimental group were not included in this analysis of post-procedural failure causes.|||participants|||Number
2800374|NCT00523978|Primary|Acute Procedural Success (APS)|Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.|371.4 Minutes (Average)|Subjects evaluated were from the modified Intent to Treat subset (mITT)or subjects that were enrolled, randomized and received treatment.|||participants|||Number
2800375|NCT00523939|Secondary|Time to Neurologic Progression||2 years|||||||
2800376|NCT00523939|Primary|Response Rate|To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.|1 year|Primary outcome measure was not assessed due to early study termination.||||||
2800377|NCT00523848|Secondary|Time to Disease Progression||Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first||||months||95% Confidence Interval|Median
2800378|NCT00523848|Secondary|Complete Response Rate||Every 3 months|Evaluable patients.|||percentage of participants||95% Confidence Interval|Number
2800379|NCT00523848|Primary|Overall Response Rate (Complete and Partial)||Every 3 months|Evaluable patients|||percentage of participants||95% Confidence Interval|Number
2800380|NCT00523809|Primary|Progression-free Survival (PFS)|Number or participants with no disease progression or death for any reason during first 100 days following transplantation. Participants followed every 3 months for first year.|100 days after transplant|Study objectives were not meet, analysis was not performed.||||||
2800381|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.|Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||Percentage of participants|||Number
2800382|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||Percentage of participants|||Number
2800383|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||BPM (beats per minute)||95% Confidence Interval|Mean
2800384|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||mmHg||95% Confidence Interval|Mean
2800385|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||mmHg||95% Confidence Interval|Mean
2800386|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of participants|||Number
2800387|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of participants|||Number
2827324|NCT00323037|Secondary|Change From Baseline in Left Ventricular Ejection Fraction||24 weeks after entry into the maintenance period|||||||
2800388|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.|||mmHg||95% Confidence Interval|Mean
2800389|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||BPM (beats per minute)||95% Confidence Interval|Mean
2800390|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
2800391|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
2800392|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
2800393|NCT00523718|Secondary|Clinical Global Impression (CGI) - Severity of Illness Item|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|14 weeks||||units on a scale||Standard Deviation|Mean
2800394|NCT00523718|Secondary|Average Hamilton Anxiety Inventory (HAM-A)|The Hamilton Anxiety Rating Scale (HARS or HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. A score of 31 or greater represents very severe anxiety severity.|14 weeks||||units on a scale||Standard Deviation|Mean
2800395|NCT00523718|Secondary|Average Hamilton Depression Inventory (HAM-D)|"The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The HAM-D 17-item scale ranges from 0 (normal) to >23 (very severe depression), with a maximum score of 52. The 24-item scale has a maximum score of 75. Severity of depression (e.g. normal or very severe) is based upon the score in the first 17-items."|14 weeks||||units on a scale||Standard Deviation|Mean
2800396|NCT00523718|Primary|Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|"The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The results can be interpreted based on the total score:~0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme.~Improvement was defined apriori as a 25% improvement from baseline"|14 weeks||||participants|||Number
2800397|NCT00523705|Secondary|Subject Satisfaction Questionnaire||Study endpoint|Not analyzed due to small number of subjects.||||||
2800398|NCT00523705|Secondary|Patient Global Evaluation of Improvement (PGE)||Throughout treatment|Not analyzed due to small number of subjects||||||
2800399|NCT00523705|Secondary|Sheehan Disability Scale (SDS)||Throughout study|Data not analyzed due to only 11 subjects.||||||
2800404|NCT00523614|Primary|Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)|The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.|01/2002 - 01/2008||||Participants|||Number
2800405|NCT00523549|Secondary|Change in Estimated Central Aortic Pressure|Change from baseline in estimated central aortic pressure at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat|||mm Hg||Standard Deviation|Mean
2800406|NCT00523549|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|Change from baseline in msDBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat population|||mm Hg||Standard Deviation|Mean
2800407|NCT00523549|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|Change from baseline in msSBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat|||mm Hg||Standard Deviation|Mean
2800408|NCT00523549|Secondary|Percent Change From Baseline in Vascular Stiffness|Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat|||percentage of change in mean AI||Standard Deviation|Mean
2800409|NCT00523549|Secondary|Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E') at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat|||ratio||Standard Deviation|Mean
2800410|NCT00523549|Secondary|Change in Left Atrial Size|Change from baseline in left atrial size at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat|||cm||Standard Deviation|Mean
2800411|NCT00523549|Primary|Change in Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in lateral mitral annular myocardial relaxation velocity (E') at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat|||cm/s||Standard Deviation|Mean
2800412|NCT00523419|Secondary|Overall Survival (OS) Time|OS was the duration from enrollment to death. For participants who lived, OS was censored at the last contact.|Baseline to 27.6 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.|||months||95% Confidence Interval|Median
2800413|NCT00523419|Secondary|Progression-Free Survival (PFS)|PFS was from date of study enrollment to first date of objectively determined progressive disease (PD) or death from any cause. For participants who did not die as of data cut-off date and who did not have objective PD, PFS was censored at date of last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from study drug) before objectively determined disease progression or death, PFS was censored at date of last objective progression-free disease assessment, before post-discontinuation chemotherapy.|Baseline to 10.4 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.|||months||95% Confidence Interval|Median
2800414|NCT00523419|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from the first objective status assessment of CR or PR to the first date of progression or death as a result of any cause: CR was achieved if all tumor lesions disappeared; PR was achieved if there was >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions with persistence (but not worsening) of >=1 nontarget lesions and no appearance of new lesions.|Baseline to 31 months|Tumor response population: participants with best overall response of complete response (CR) and partial response (PR).|||months|||Number
2800415|NCT00523419|Secondary|Number of Participants With Adverse Events (Pharmacology Toxicity)|Pharmacology toxicity was defined as serious and non-serious adverse events. Summaries of these adverse events are located in the Reported Adverse Event Section.|Baseline to 21 months|Full analysis population: all participants who were treated with at least one dose of the study regimen|||participants|||Number
2800416|NCT00523419|Secondary|Correlation of Disease Outcome With Pharmacogenomic Analysis|It was planned to examine methylthioadenosine phosphorylase (MTAP) gene deletion, folate receptor alpha (FRα) and folylpoly-gamma-glutamate synthetase (FPGS) expression, and to correlate the results with the clinical data to determine the association between these factors and clinical outcome to treatment. However, due to the small number of participants with partial response (n=1), the planned statistical analyses that would correlate responders/non responders with pharmacogenomics data are no longer valid and the analyses were not conducted.|Baseline to 21 months|Since this outcome measure was not analyzed due to the inadequate number of responders, zero participants were analyzed.|||correlation coefficient|||Number
2800417|NCT00523419|Secondary|Time to Treatment Failure|When the protocol was written, time to treatment failure (TTTF) was included as a secondary endpoint. However, it was subsequently realized that due to the design of the study, participants are treated until disease progression or discontinuation from study treatment, not for a fixed number of cycles. Therefore, it was concluded that analysis of TTTF was inappropriate with the current study design and the analysis was not conducted, since it would be essentially the same as Progression-Free Survival.|Baseline to 21 months|Since this outcome measure was not analyzed due to the study design, zero participants were analyzed.|||days||Standard Deviation|Mean
2800418|NCT00523419|Primary|Percentage of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis * 100.|Baseline to 21 months|Participants who qualified for tumor response analysis are those with histological evidence of high grade locally advanced or metastatic osteosarcoma and treatment with at least 1 dose of study drug. Three participants died before the first tumor assessment and 1 participant discontinued without any tumor assessments and were considered Unknown.|||percentage of participants||95% Confidence Interval|Number
2800419|NCT00523367|Secondary|COPD/GERD Patients Treated With High Dose Esomeprazole|COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.|1 year|||||||
2800421|NCT00523341|Secondary|Bone Histology at Month 84|Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 84.|||biopsies|biopsies||Number
2800422|NCT00523341|Secondary|Bone Histology at Month 24|Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 24|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 24.|||biopsies|biopsies||Number
2800423|NCT00523341|Secondary|Bone Histomorphometry: Mineralization Lag Time|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken.~Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization and is calculated by dividing the osteoid width by the apposition rate."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralization lag time data.|||days||Standard Deviation|Mean
2800424|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Volume|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoid volume is the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid volume data.|||percentage of total bone tissue||Standard Deviation|Mean
2800425|NCT00523341|Secondary|Bone Histomorphometry: Activation Frequency|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency. Activation frequency is calculated as the bone formation rate / wall width."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available activation frequency data.|||/year||Standard Deviation|Mean
2800426|NCT00523341|Secondary|Bone Histomorphometry: Formation Period|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Formation period (FP) is the mean time required to rebuild a new bone structural unit or osteon from the cement line back to the bone surface at a single location, and is given by wall width / adjusted apposition rate."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available formation period data.|||days||Standard Deviation|Mean
2800427|NCT00523341|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - volume based is the calculated rate at which cancellous bone volume is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.|||percent of bone volume per year||Standard Deviation|Mean
2800428|NCT00523341|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - surface based is the calculated rate at which cancellous bone surface is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone surface)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.|||μm³/μm²/year||Standard Deviation|Mean
2800429|NCT00523341|Secondary|Bone Histomorphometry: Adjusted Apposition Rate|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the average rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface)."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available adjusted apposition rate data.|||μm/day||Standard Deviation|Mean
2800430|NCT00523341|Secondary|Bone Histomorphometry: Mineral Apposition Rate|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineral apposition rate data.|||μm/day||Standard Deviation|Mean
2800431|NCT00523341|Secondary|Bone Histomorphometry: Mineralizing Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralizing surface data.|||percentage of bone surface||Standard Deviation|Mean
2800432|NCT00523341|Secondary|Bone Histomorphometry: Double-label Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The presence of double labels indicates that normal bone mineralization was actively occurring over the entire labeling interval. Double-label surface is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available double-label surface data.|||percentage of bone surface||Standard Deviation|Mean
2800433|NCT00523341|Secondary|Bone Histomorphometry: Single-label Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. A single label is deposited if formation either started or ended during the interval between the uses of the two courses of tetracycline administration. Single-label surface is expressed as a percentage of total bone surface."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available single-label surface data.|||percentage of bone surface||Standard Deviation|Mean
2800434|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured using TRAP staining and is expressed per 100 mm of bone surface.~Da"|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/100 mm||Standard Deviation|Mean
2800435|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number by TRAP - Length Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured using TRAP staining and is expressed per mm of bone."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/mm||Standard Deviation|Mean
2800436|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured by quantitative histomorphometry and is expressed per 100 mm of bone surface area."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/100 mm||Standard Deviation|Mean
2800437|NCT00523341|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Osteoclast number was measured by quantitative histomorphometry and is expressed per mm of bone."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.|||1/mm||Standard Deviation|Mean
2800438|NCT00523341|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|"Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.~Eroded surface/bone surface is the percentage of bone surface occupied by eroded (resorption) cavities (Howships lacunae), with or without osteoclasts."|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available eroded surface/bone surface data.|||percentage of bone surface||Standard Deviation|Mean
2800439|NCT00523341|Secondary|Bone Histomorphometry: Wall Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available wall thickness data.|||μm||Standard Deviation|Mean
2800440|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid thickness (width) is the mean thickness of osteoid seams on cancellous surfaces. Osteoid thickness is normally <12.5 µm. Increased osteoid thickness suggests abnormal mineralization (osteomalacia).|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid thickness data.|||μm||Standard Deviation|Mean
2800441|NCT00523341|Secondary|Bone Histomorphometry: Osteoid Surface|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid surface is the percent of bone surface covered in osteoid.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid surface data.|||percentage of total bone surface||Standard Deviation|Mean
2800442|NCT00523341|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoblast - osteoid interface data.|||percentage of osteoid surface||Standard Deviation|Mean
2800443|NCT00523341|Secondary|Bone Histomorphometry: Surface Density|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available surface density data.|||mm²/mm³||Standard Deviation|Mean
2800444|NCT00523341|Secondary|Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by tartrate-resistant acid phosphatase (TRAP) staining histomorphometry.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.|||percentage of total bone tissue volume||Standard Deviation|Mean
2800445|NCT00523341|Secondary|Bone Histomorphometry: Cortical Width|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cortical width is the average width of both inner and outer cortices.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cortical width data.|||μm||Standard Deviation|Mean
2800446|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Thickness|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Mean trabecular thickness is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Trabecular thickness is reduced by aging and osteoporosis.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular thickness data.|||μm||Standard Deviation|Mean
2800447|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Separation|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular separation is the mean distance between trabeculae (measured by integrated computer graphics). Trabecular separation increases with trabecular bone loss.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular separation data.|||μm||Standard Deviation|Mean
2800448|NCT00523341|Secondary|Bone Histomorphometry: Trabecular Number|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular number is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Trabecular number is a measure of trabecular connectivity and decreases with bone loss.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular number data.|||1/mm||Standard Deviation|Mean
2800449|NCT00523341|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.|||percentage of total bone tissue volume||Standard Deviation|Mean
2800450|NCT00523341|Secondary|Serum Denosumab Concentration|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.|Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)|Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times.|||ng/mL||Standard Deviation|Mean
2800451|NCT00523341|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10||Baseline (of extension study) and day 10|Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008.|||percent change||Inter-Quartile Range|Median
2800452|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in P1NP by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
2800453|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in CTX-1 by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
2800454|NCT00523341|Secondary|Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
2800455|NCT00523341|Secondary|Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
2800456|NCT00523341|Secondary|Number of Participants With Non-Vertebral Fractures|Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|84 months|All enrolled participants|||participants|||Number
2800457|NCT00523341|Secondary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.|84 months|All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.|||participants|||Number
2800458|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit|1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800459|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800460|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800461|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800462|NCT00523341|Secondary|Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit|1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800768|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.|||IU/mL||Standard Deviation|Mean
2800463|NCT00523341|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800464|NCT00523341|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800465|NCT00523341|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."|||percent change||95% Confidence Interval|Least Squares Mean
2800466|NCT00523341|Primary|Number of Participants With Antibodies to Denosumab||Every 12 months through Month 84|All participants who received at least 1 dose of denosumab|||participants|||Number
2800467|NCT00523341|Primary|Number of Participants With Laboratory Toxicities of Grade ≥ 3|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.|84 months|All participants who received at least 1 dose of denosumab|||participants|||Number
2800468|NCT00523341|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.|84 months|All participants who received at least one dose of denosumab.|||participants|||Number
2800469|NCT00523302|Primary|THE HAMILTON DEPRESSION RATING SCALE (HRDS)|To assess each participant's level of depression, the HRDS will be administered. The HRDS is a 17-item clinician-rated scale that is designed to evaluate depressed mood, vegetative and cognitive symptoms of depression, and comorbid anxiety symptoms. Eight items are scored on a 5-point scale, ranging from 0-4, where 0=not present and 4=severe. Nine items are scored from 0-2, where 0=None, 1=Mild, and 2=Severe. The final, total score ranges from 0-52. Scores in the range of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression.|Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up||||units on a scale||Standard Deviation|Mean
2800470|NCT00523302|Primary|THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified|"To assess the impact of fibromyalgia on each participant's function, the FIQ-modified (2002) version will be administered before each study visit. The FIQ-modified (2002) version assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued.~The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning."|Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up||||units on a scale||Standard Deviation|Mean
2800471|NCT00523302|Primary|Average Pain|To assess each participant's average Pain in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up||||units on a scale||Standard Deviation|Mean
2800472|NCT00523237|Primary|The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir|evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir|24 weeks|With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.|||percentage|||Number
2800473|NCT00522951|Secondary|Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions|ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||ICC|||Number
2800474|NCT00522951|Secondary|Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist|CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||CNR||Standard Deviation|Mean
2800769|NCT00520494|Primary|Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12||On Day 12|The intention-to-treat (ITT) data set comprised all patients who were treated with the study drug and completed Day 12.|||proportion of patients||95% Confidence Interval|Number
2800475|NCT00522951|Secondary|Lesion Size Evaluated by Independent Radiologist|Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||mm||Standard Deviation|Mean
2800476|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by Investigator|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
2800477|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by TPE|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
2800478|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
2800479|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure|||participants|||Number
2800480|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
2800481|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
2800482|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
2800483|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)|Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||participants|||Number
2800484|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Investigator|Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
2800485|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Blinded Reader|Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
2800486|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
2800487|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||scores on a scale||Standard Deviation|Mean
2800488|NCT00522951|Primary|Number of Lesions Detected by Blinded Readers (BR) and Investigator|Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.|||lesions||Standard Deviation|Mean
2800492|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 10 to 12 of Treatment|The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 10 to Month 12|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations|||Participants|||Number
2800493|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 1 to 3 of Treatment|The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 1 to Month 3|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations|||Participants|||Number
2800494|NCT00522873|Primary|Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)|The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.|Up to one year|For the DRSP/E2 group only - Primary analysis set (PAS): All subjects from the full analysis set (FAS) who either had a biopsy result classified as ‘normal’ or ‘hyperplasia or worse’ after a year of treatment or who prematurely discontinued the study before Cycle 13 with a biopsy classified as ‘hyperplasia or worse’.|||Participants|||Number
2800495|NCT00522795|Primary|Complete Pathologic Response|Per pathology review post surgery|At Surgery approximately 4weeks after last treatment|Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.|||participants|||Number
2800496|NCT00522626|Secondary|Maternal Physiologic Parameters||120 minutes|||||||
2800497|NCT00522626|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute|60 minutes|Total number of subjects completing assessment|||beats per minute||Standard Deviation|Mean
2800498|NCT00522548|Secondary|Pharmacokinetics (Mycophenolic Acid Area Under the Curve) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients|Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose). A mycophenolic acid area under the curve value, also known as AUC represents drug exposure.|1 and 6 months|Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.|||mg*hr/L||Standard Deviation|Mean
2800499|NCT00522548|Secondary|Pharmacokinetics (Mycophenolic Acid Maximum Concentration) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients|Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).A mycophenolic acid drawn at the peak level is called C Max or maximum concentration.|1 and 6 months|Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.|||mg/L||Standard Deviation|Mean
2800500|NCT00522548|Secondary|Pharmacokinetics (Mycophenolic Acid Trough Levels) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients|Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of enteric coated mycophenolate sodium and mycophenolate mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).|1 and 6 months|Any participant who completed at least one pharmacokinetic studies was included in this analysis.|||mg/L||Standard Deviation|Mean
2800501|NCT00522548|Secondary|Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates were used as part of a measure of renal function and measured at 24 weeks in patients who were still participating in the study at that point.|6 months|Any patient with Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates at 24 weeks was included in the analysis|||MDRD (mL/min/1.73m2)||Standard Deviation|Mean
2800502|NCT00522548|Secondary|Serum Creatinine in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|Serum creatinine lab values were used as part of a measure of renal function at 24 weeks for any patient that was still participating in the study at this time-point.|6 months|Any patient with serum creatinine values available at 24 weeks|||serum creatinine mg/dL||Standard Deviation|Mean
2800503|NCT00522548|Secondary|The Incidence of Rejection in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz.|All rejection episodes of the kidney transplant were proven by kidney transplant biopsy and were measured at 24 weeks for all patients still participating in the study at that timepoint.|6 months|Included any patient who experienced rejection while enrolled in the study up to 6 months post-transplant.|||participants|||Number
2800513|NCT00522431|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90|Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL|0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90|Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis|||percentage of participants|||Number
2800504|NCT00522548|Secondary|The Incidence of the Occurrence of Lower Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant. Patients who withdrew from the study only had data included up to the point of withdraw. No values were carried forward.|6 months|Any patient with a mean GSRS subscale score > 1 on dimensions constipation or diarrhea were considered to have lower GI symptoms.|||Participants|||Count of Participants
2800505|NCT00522548|Secondary|The Incidence of the Occurrence of Upper Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant.|6 months|Any patient with mean GSRS subscale score >1 from dimensions: abdominal pain, indigestion, or reflux were considered to have upper GI symptoms.|||Participants|||Count of Participants
2800506|NCT00522548|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Score Changes From Baseline to 24 Weeks After Transplant in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, indigestion, constipation, abdominal pain, and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 after transplant.|baseline (pre-transplant to two days after transplant) and at 6 months after transplant.|Patients who withdrew from the study before 24 weeks were excluded from this analysis.|||Participants|||Count of Participants
2800507|NCT00522548|Secondary|The Incidence of Intolerance (Defined as Transient Dose Reduction or Transient Discontinuation of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|The incidence of intolerance was defined as transient dose reduction or transient discontinuation of enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent manufactured by Sandoz meaning doses could subsequently be resumed or increased back to original starting dose, once intolerance resolved.|6 months|Based on number of patients participating in the study at 6 months|||participants|||Number
2800508|NCT00522548|Secondary|The Incidence of the Requirement of Full Dose Proton Pump Inhibitors in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz|If patients were not on any medications from a medication class known as H-2 antagonists, they were started on ranitidine 150 mg orally twice daily after transplant (with dose adjusted for renal function). Patients were excluded if they were on proton pump inhibitor at time of study screening, however some patients required addition of proton pump inhibitor post-study enrollment. If a patient had upper gastrointestinal side effects such as acid reflux unreleived on ranitidine therapy or nausea, they were switched to a proton pump inhibitor.|6 months|Based on number of patients participating in study at 6 months|||participants|||Number
2800509|NCT00522548|Primary|Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz|At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.|6 months|Based on the number of patients who were participating in the trial at that timepoint and had not withdrawn at 24 weeks|||participants|||Number
2800510|NCT00522457|Secondary|Clinical Benefit Rate|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed|||participants|||Number
2800511|NCT00522457|Secondary|Duration of Response|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed|||participants|||Number
2800512|NCT00522457|Primary|Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)||patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed. The primary endpoint was the objective response rate (ORR) to ertumaxomab (best response during the course of the study), defined as the number of patients with CR or PR according to RECIST, relative to the total population of treated patients|||participants|||Number
2800770|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.|||IU/mL||Standard Deviation|Mean
2800514|NCT00522431|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90|Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL|0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90|Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis|||percentage of participants||95% Confidence Interval|Number
2800515|NCT00522418|Secondary|Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures|The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800516|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms VNS + BMP (N=17) and BMP alone (N=17), with an overall QOLIE-89 at baseline and any other baseline visit up to 12 months. Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40|||units on a scale||Standard Error|Least Squares Mean
2800517|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms, VNS + BMP (N=30) and BMP alone (N=31), with an overall QOLIE-89 at baseline and any other post baseline visit up to 12 months. Subgroup Analysis of population with Baseline Adverse Event Profile Score >= 40|||Units on a Scale||Standard Error|Least Squares Mean
2800518|NCT00522418|Secondary|Percent of Participants Who Were Compliant With the Protocol|Retention rate in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800519|NCT00522418|Secondary|Change in the Number of Anti-epileptic Drugs Prescribed|Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800520|NCT00522418|Secondary|Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800521|NCT00522418|Secondary|Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800522|NCT00522418|Secondary|Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800523|NCT00522418|Secondary|Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800771|NCT00520494|Secondary|Total Serum IgG Trough Levels at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 total serum IgG results were available.|||g/L||Standard Deviation|Mean
2800524|NCT00522418|Secondary|Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal|Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800525|NCT00522418|Secondary|Retention Rate|Percent of participants who were compliant with the protocol.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800526|NCT00522418|Secondary|Changes in Anti-epileptic Drugs (AEDs)|Change from baseline in number of AED medications by visit|Change from baseline in number of AEDs at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for fifty-nine (59) patients.|||Number of AEDs Taken||Full Range|Median
2800527|NCT00522418|Secondary|Change From Baseline in Adverse Event Profile (AEP) Score|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Mean change from baseline AEP Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a scale||Standard Deviation|Mean
2800528|NCT00522418|Secondary|Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months|The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Mean change from baseline CGI-I Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a Scale||Standard Deviation|Mean
2800529|NCT00522418|Secondary|Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|Mean change from baseline NDDI-E Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a Scale||Standard Deviation|Mean
2800530|NCT00522418|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|Mean change from baseline CES-D Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Units on a Scale||Standard Deviation|Mean
2800531|NCT00522418|Secondary|Seizure Free Days Over the Last 6 Months||Over the last 6 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800532|NCT00522418|Secondary|Seizure Free Days|Seizure free days is defined as the time from last seizure to study exit date.|From the patient's last seizure to the study exit date|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800533|NCT00522418|Secondary|Mean Percent Change in Seizure Frequency|Percent change in total seizuires per week from baseline at 12 months|Mean percent change from baseline in seizure frequency at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||Percent Change||Standard Deviation|Mean
2800534|NCT00522418|Secondary|Percent of Patients That Are Seizure Free|Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.|3, 6, 9, 12, 15, 18, 21, 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.||||||
2800535|NCT00522418|Secondary|Response Rate|Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.|Number of Responders at 12 Months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||participants|||Number
2800772|NCT00520494|Secondary|Total Serum IgG Trough Levels on Day 12||On Day 12|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||g/L||Standard Deviation|Mean
2800536|NCT00522418|Primary|Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|Mean change from baseline QOLIE-89 Overall Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.|||units on a scale||Standard Deviation|Mean
2800537|NCT00522392|Secondary|Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI)|The combined score on the FACT-Ntx TOI is of interest. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible quality of life) -100 (best possible quality of life). The primary QOL endpoint is defined as the change in the FACT-Ntx TOI score from registration to 6 months post consolidation treatment.|Baseline and 6 months post consolidation treatment|Patients with both assessments complete at baseline and 6 months post consolidation treatment were included in this analysis.|||units on a scale||Full Range|Mean
2800538|NCT00522392|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients|||Months||95% Confidence Interval|Median
2800539|NCT00522392|Secondary|Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])|"CR:~Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria:~Negative immunofixation on the serum and urine at two consecutive times~Disappearance of any soft tissue plasmacytomas~≤5% plasma cells in bone marrow~If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times~VGPR:~Serum and urine M-component detectable by immunofixation but not on electrophoresis OR~>=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP)~If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a >90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria"|Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|Patients with measurable disease at randomization were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2800540|NCT00522392|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment.~The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued."|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients|||Months||95% Confidence Interval|Median
2800541|NCT00522379|Secondary|"The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|"Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.|||Hours||Standard Deviation|Mean
2800542|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?|"Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800543|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?|"Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800822|NCT00520130|Secondary|Early Treatment Related Mortality|Any death occurring within 28 days after transplantation in a patient in continuous remission.|Less than or equal to 28 days after transplantation|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||participants|||Number
2800544|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?|"Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800545|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average?"|"Item = What proportion of the waking day is the subject off, on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is off a larger portion of the waking day.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800546|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly?"|"Item = Do off periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods come on suddenly, within a few seconds.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800547|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable?"|"Item = Are off periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods are unpredictable.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800548|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable?"|"Item = Are off periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods are predictable.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800549|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia|"Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||participants|||Number
2800550|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?|"Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||participants|||Number
2800562|NCT00522275|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)|Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.|Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.|||percentage change||Full Range|Median
2800551|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?|"Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||participants|||Number
2800552|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?|"Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||participants|||Number
2800553|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||units on a scale||Standard Deviation|Mean
2800554|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.|||units on a scale||Standard Deviation|Mean
2800555|NCT00522379|Secondary|The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary||From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.|||Hours||Standard Deviation|Mean
2800556|NCT00522379|Secondary|"The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|"Time On is defined as when the patient has the effect of anti-Parkinson's medication."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||Hours||Standard Deviation|Mean
2800557|NCT00522379|Secondary|"The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|"Time On is defined as when the patient has the effect of anti-Parkinson's medication."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.|||Hours||Standard Deviation|Mean
2800558|NCT00522379|Secondary|"The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|"Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||Hours||Standard Deviation|Mean
2800559|NCT00522379|Primary|"The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|"Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.|||Hours||Standard Deviation|Mean
2800560|NCT00522301|Primary|Progression-free Survival (PFS) Rate at 12 Months|All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.|1 year|Protocol terminated prior to primary outcome evaluation. All 5 patient were evaluable for toxicity only.||||||
2800561|NCT00522275|Secondary|Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.|Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.|||percentage of subjects|||Number
2800563|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)|Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
2800564|NCT00522275|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
2800565|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||subjects|||Number
2800566|NCT00522171|Secondary|Total Number of Hours From Drain Placement to Drain Removal|Total number of hours from drain placement to drain removal|From drain placement to drain removal (</= 770 hours)|terminated study|||hours||Standard Deviation|Mean
2800567|NCT00522171|Primary|Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal|Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure|From the time of drain placement to time of drain removal (</= 770 hours)|ITT|||milliliter||Standard Deviation|Mean
2800568|NCT00522041|Secondary|Percentage of Responders|"Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled least possible pain and the right-end of the visual analog scale was labelled worst possible pain. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18."|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.|||Percentage of responders|||Number
2800569|NCT00522041|Secondary|Time to an Improvement in Pain Intensity|"Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled least possible pain and the right-end of the visual analog scale was labelled worst possible pain. The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity."|Baseline to Day 21|Intent-to-treat population: All randomized participants who had applied the study medication at least once. Only participants with an improvement in pain intensity were included in the analysis.|||Days||Standard Error|Mean
2800570|NCT00522041|Primary|Change From Baseline in Pain Intensity at Days 14-18|"Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled least possible pain and the right-end of the visual analog scale was labelled worst possible pain. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement."|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.|||Units on a scale||Standard Error|Mean
2800571|NCT00521989|Secondary|To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS.||Day 98|||||||
2800572|NCT00521989|Primary|Change From Baseline to Day 98 Using the WOMAC Pain Question #1|"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome."|Baseline to Day 98|ITT population|||millimeters||Standard Deviation|Mean
2800573|NCT00521976|Secondary|Recurrent Troponin-T (TnT) Positive Events|Recurrent Troponin-T (TnT) positive events; Symptoms of coronary ischemia associated with TnT >0.05 ng/mL with a pattern of gradual rise and fall in TnT|24 months.||||Participants|||Number
2800574|NCT00521976|Primary|Total Mortality.||24 months.||||Participants.|||Number
2800575|NCT00521924|Secondary|DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI).|These were not prespecified key secondary outcomes; therefore, results will not be disclosed.|Weeks 14, 38, and 62|||||||
2800576|NCT00521924|Primary|Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Patients can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|after 38 weeks|This trial terminated early due to poor enrollment. Since none of the randomized patients reached Week 38, no change of DAS28 between baseline and Week 38 could be analyzed.||||||
2800577|NCT00521885|Secondary|Deep Vein Thrombosis|Confirmed by Lower Extremity Ultra-sonogram|14 Days|||||||
2803699|NCT00497796|Secondary|Number of Participants Who Died Within 6 Months Post-Transplantation||6 months post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.|||participants|||Number
2800579|NCT00521599|Primary|Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.|Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.|Baseline and Week 8 End|All treated subjects included all but one placebo-treated subject from the All Randomized Subjects data set, who was randomized, but never treated in either the open-label or double-blind Treatment Periods due to non-compliance with the protocol|||liters/minute||Standard Deviation|Least Squares Mean
2800580|NCT00521586|Other Pre-specified|Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.|Signing of informed consent up to 194 days after re-vaccination at Year 5|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
2800581|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).|Within 30 Minutes After 13vPnC (Year 5)|Safety population at Year 5 included all participants who had received at least 1 vaccination and did not lack any safety data.|||percentage of participants|||Number
2800582|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination (Dose 2, year 0) and did not lack any safety data.|||percentage of participants|||Number
2800583|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data.|||percentage of participants|||Number
2800584|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)|Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.|||percentage of participants|||Number
2800585|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)|Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
2800586|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)|Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
2800598|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.|||microgram per milliliter(mcg/mL)||95% Confidence Interval|Geometric Mean
2800587|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.|||percentage of participants|||Number
2800588|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here,n=number of participants with known values.|||percentage of participants|||Number
2800589|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.|||percentage of participants|||Number
2800590|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and the specified timepoints.|||fold-rises||95% Confidence Interval|Geometric Mean
2800591|NCT00521586|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Years 0 through Year 5 within the protocol specified time window. Here, n=number of participants with valid and determinate assay results for the specified serotype at the given time points.|||mcg/mL||95% Confidence Interval|Geometric Mean
2800613|NCT00521456|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
2800614|NCT00521365|Secondary|Number of Participants With >7% Increase in Weight|Number of participants with >7% increase in weight from baseline to end of study.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Participants|||Number
2800592|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
2800593|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
2800594|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
2800595|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
2800596|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
2800597|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||mcg/mL||95% Confidence Interval|Geometric Mean
2800615|NCT00521365|Secondary|Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||cm||Standard Deviation|Mean
2801549|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2800599|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and all the specified timepoints.|||fold-rises||95% Confidence Interval|Geometric Mean
2800600|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window.|||titers||95% Confidence Interval|Geometric Mean
2800601|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
2800602|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||titers||95% Confidence Interval|Geometric Mean
2800603|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both 1 month after 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|||fold-rises||95% Confidence Interval|Geometric Mean
2800616|NCT00521365|Secondary|Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Kg||Standard Deviation|Mean
2800617|NCT00521365|Secondary|Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800604|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 0 and 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.|||titers||95% Confidence Interval|Geometric Mean
2800605|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.|||fold-rises||95% Confidence Interval|Geometric Mean
2800606|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5.n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws for each treatment arm, respectively.|||titers||95% Confidence Interval|Geometric Mean
2800607|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.|||titers||95% Confidence Interval|Geometric Mean
2800608|NCT00521586|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose at year 0|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation. n=participants with valid and determinate assay results for the specified serotype at the given visit.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2800609|NCT00521586|Primary|Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1|Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.|1 month after Dose 1|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation.|||percentage of participants||95% Confidence Interval|Number
2800610|NCT00521456|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population|||Percentage of patients with ≥ 3 lines|||Number
2800611|NCT00521456|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population|||millimeters squared (mm²)||Standard Deviation|Mean
2800612|NCT00521456|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population|||% of participants with a score of 0|||Number
2800618|NCT00521365|Secondary|Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|"Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF).~SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18."|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800619|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800620|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.|Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life).|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800621|NCT00521365|Secondary|Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).|Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800622|NCT00521365|Secondary|Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).|Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800623|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).|"Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward||||Participants|||Number
2800624|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)|"Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward||||Participants|||Number
2800625|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3|Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 2 weeks|Outcome was comparing the data at baseline with the specific data at visit 3 (not with the LOCF), since only 79 patients completed YMRS at visit 3 the number of patients analyzed is different respect to the LOCF (88).|||Scores on a scale||Standard Deviation|Mean
2800626|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.|Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 1 week|Outcome was comparing the data at baseline with the specific data at visit 2(not with the LOCF), since only 78 patients completed YMRS at visit 2 the number of patients analyzed is different respect to the LOCF (88).|||Scores on a scale||Standard Deviation|Mean
2800627|NCT00521365|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)|Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline and 3 weeks|Modified Intention to treat patients (88). Patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.|||Scores on a scale||Standard Deviation|Mean
2800628|NCT00521352|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.~Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.~= Normal, not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients"|4 weeks||||responders (CGI-S = 1 or 2)|||Number
2800629|NCT00521352|Primary|Hamilton Depression Rating Scale (HDRS), 28 Item Version|"The Hamilton Rating Scale for Depression (HRSD) is a multiple item questionnaire used to provide an indication of depression severity. The 28-, rather then 17- or 24-, item version was used to assess subjects in this protocol.~28-item minimum score = 0 28-item maximum score = 84~Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement."|4 weeks||||responders|||Number
2800630|NCT00521352|Primary|Panic Disorder Severity Scale (PDSS)|"The Panic Disorder Severity Scale is a questionnaire developed for measuring the severity of panic disorder symptoms.~The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.~Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms."|4 weeks||||responders|||Number
2800631|NCT00521339|Secondary|Mean Residence Time (MRT) During the Extension Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Days169/170) was calculated as follows: Cavg = (Day 169/170)/(12)|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||hours||Geometric Coefficient of Variation|Geometric Mean
2800632|NCT00521339|Secondary|Accumulation Index During the Extension Phase|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Not able to calculate the Accumulation Index at this time point; insufficient data collection for this calculation.||||||
2800633|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Extension Phase|For Days 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC12) where λ = the terminal elimination rate constant|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||mL||Geometric Coefficient of Variation|Geometric Mean
2800634|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) During the Extension Phase|For 169/170, apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC12|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.|||mL/hour||Geometric Coefficient of Variation|Geometric Mean
2800635|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½) During the Extension Phase|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||hours||Geometric Coefficient of Variation|Geometric Mean
2800636|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Extension Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 169/170. Actual times utilized were used for reporting Tmax values.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||hours||Geometric Coefficient of Variation|Geometric Mean
2800637|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Apremilast (Cmax) During the Extension Phase|The maximum observed plasma concentration of CC-10004 (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 169/170.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2800638|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12) During the Extension Phase|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS).|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2800639|NCT00521339|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item Health Survey (SF-36) Scores, Mental and Physical Components to Week 12|The SF-36 was a self-administered instrument consisting of 8 multi-item scales that assess 8 health domains: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A higher score post-baseline is indicative of improvement in the disease state. The summary physical health score included physical functioning, role-physical, bodily pain and general health. The summary mental health score included: vitality, social functioning, role-emotional and mental health. The resulting score for each subscale is then standardized, to obtain values ranging from 0 to 100, with higher values indicating a better QOL.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||units on a scale||Standard Deviation|Mean
2800698|NCT00521001|Secondary|Confirmed Response Rate (Complete Response and Partial Response)|Confirmed response rates will be evaluated by dividing the number of confirmed responders (i.e. patients that achieve a CR or PR on consecutive evaluations) by the total number of evaluable patients. Confidence intervals for the true response rate will be calculated using the properties of the binomial distribution.|Up to 5 years||||percentage of confirmed responses||95% Confidence Interval|Number
2800640|NCT00521339|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12|DLQI was the dermatology-specific quality of life (QOL) measure used for the psoriatic population. The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on a participants QoL, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Possible responses for each of the 10 items are: not at all, a little, a lot, and very much. Each question is rated on a scale of 0 to 3 with a total range of 0 to 30. Higher scores indicate greater impact of disease on QOL|Baseline to Week 12|Only those with both a baseline and final/termination visit assessment were included in the analyses of change from baseline. Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2800641|NCT00521339|Secondary|Percent Change From Baseline in the Dendritic Cell (CD83) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800642|NCT00521339|Secondary|Percent Change From Baseline in the IL2 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800643|NCT00521339|Secondary|Percent Change From Baseline in the Chemokine Ligand (CXCL9) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800644|NCT00521339|Secondary|Percent Change From Baseline in the IL10 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800645|NCT00521339|Secondary|Percent Change From Baseline in the Interferon (INF) Gamma Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800646|NCT00521339|Secondary|Percent Change From Baseline in the Tumor Necrosing Factor (TNF) Alpha Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Week 0 to Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800647|NCT00521339|Secondary|Percent Change From Baseline in the IL17A Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800648|NCT00521339|Secondary|Percent Change From Baseline in the MX1 (Gene That Encodes the Interferon-induced p78 Protein) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800745|NCT00520676|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
2800649|NCT00521339|Secondary|Percent Change From Baseline in the IL8 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800650|NCT00521339|Secondary|Percent Change From Baseline in the pluripotent19 (P19) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800651|NCT00521339|Secondary|Percent Change From Baseline in the keratin16 (K16) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800652|NCT00521339|Secondary|Percent Change From Baseline in the Defensin Beta 4 (DEFB4) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) i being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800653|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Extension Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.~Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event."|Week 12 to Week 24|Safety population consisted of all participants who were enrolled and received at least one dose of study medication in treatment Extension Phase.|||participants|||Number
2800654|NCT00521339|Secondary|Percent Change From Baseline in the p40 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800655|NCT00521339|Secondary|Percent Change From Baseline in the Interleukin (IL) IL-22 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800656|NCT00521339|Secondary|Percent Change From Baseline in the Inducible Nitric Oxide (iNOS) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800657|NCT00521339|Secondary|Percent Change From Baseline of Epidermal Thickness in the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800765|NCT00520494|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||participants|||Number
2800658|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800659|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Dermis of Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800660|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800661|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800662|NCT00521339|Secondary|Percent Change From Baseline of CD11c in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800663|NCT00521339|Secondary|Percent Change From Baseline of CD 11c in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800664|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800665|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.|||percent change||Full Range|Median
2800677|NCT00521339|Secondary|Percent of Participants With Psoriatic Arthritis Who Achieved an American College of Rheumatology 20% Improvement (ACR-20) Response at Week 12|"A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last observation carried forward was used. Only a small percentage of participants had psoriatic arthritis.|||percentage of participants|||Number
2800666|NCT00521339|Secondary|Change From Baseline in Peripheral Blood T Cell, B Cell, and NK Cell Subsets at Week 12|T cells or T lymphocytes, a type of white blood cell, play a role in cell-mediated immunity. T cells are distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on the cell surface and mature in the thymus. B cells, a type of lymphocyte in the humoral immunity of the adaptive immune system can be distinguished by the presence of a protein on the B cells outer surface called a B cell receptor (BCR). This receptor protein allows a B cell to bind to a specific antigen and make antibodies against antigens [(antigen-presenting cells APCs)], and to develop into memory B cells after activation by antigen interaction. Natural Killer Cells (NK) are a type of cytotoxic lymphocyte critical to the innate immune system. Their role is analogous to that of cytotoxic T cells in the vertebrate adaptive immune response. They constitute the third kind of cells differentiated from the common lymphoid progenitor generating B and T lymphocytes and mature in the bone marrow.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the peripheral blood T cell, B cell and NK cell subsets at Baseline and Week 12.|||percentage of lymphocytes||Standard Deviation|Mean
2800667|NCT00521339|Secondary|Mean Residence Time (MRT) During the Treatment Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Day 85 was calculated as follows: Cavg = (Day 85 AUC0-12)/(12).|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast|||hours||Geometric Coefficient of Variation|Geometric Mean
2800668|NCT00521339|Secondary|Accumulation Index (R)|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2800669|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Treatment Phase|"Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) (for Days 1, 85, and 169/170)~For Day 1, Vz/F was not calculated.~For Days 85 and 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC^12)"|Day 85|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||mL||Geometric Coefficient of Variation|Geometric Mean
2800670|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CLz/F) During the Treatment Phase|"The apparent total clearance of apremilast from plasma after extravascular administration (CLz/F); for Day 1, apparent clearance of drug from plasma (CL/F) was not calculated.~For Day 85, Apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC^12 where τ=12."|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.|||mL/hour||Geometric Coefficient of Variation|Geometric Mean
2800671|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½)|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2800672|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Treatment Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 85. Actual times utilized were used for reporting Tmax values.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.|||hours||Full Range|Median
2800673|NCT00521339|Secondary|Trough Plasma Concentration (Cmin)|The trough observed plasma concentration of apremilast (Cmin) was determined directly from the observed pre-AM dose concentration on Day 85.|Day 85 Pre-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2800674|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Medication (Cmax)|The maximum observed plasma concentration of apremilast (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 1, 85, and 169/170, respectively.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2800675|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12)|"Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). For Day 1, AUC0-12 was calculated, using linear trapezoidal area method in WinNonlin (linear-linear trapezoidal). For Days 85 and 169/170, the AUC during a dosing interval (12 hours) (AUC0-12), was calculated at steady-state using the partial area function within WinNonlin.~."|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2800676|NCT00521339|Secondary|Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase|"A relapse was defined as a 50% loss of maximal American College of Rheumatoid (ACR) Score improvement in participants with psoriatic arthritis who achieved at least an ACR 20 score during the treatment phase.~Relapses were only captured prior to the prescription of concomitant psoriatic treatment."|Observational follow up phase; Days 168 to Day 196|This endpoint was not summarized since there were only 8 participants with psoriatic arthritis enrolled in the study and only 2 participants who achieved an ACR 20 response during the treatment phase.||||||
2800697|NCT00521014|Primary|Progression-free Survival Rate|"after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:~≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR~appearance of any new lesions"|up to 3 years||||years||Full Range|Mean
2800678|NCT00521339|Secondary|Time to Relapse of Psoriasis (50% Loss of Maximal PASI Score Improvement in Participants Who Achieved at Least PASI-50 During the Treatment Phase) During the Observational Follow up Phase|Time to relapse of psoriasis (50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment phase) during the observational follow up phase was not analyzed. Time to relapse of psoriasis was defined as a 50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment or extension phase. The lesion on each area of the body was assessed for redness, thickness, and scaling.|28-day Observational Follow-up Phase; Days 168 to Day 196.|Time to relapse of psoriasis was not analyzed due to the small number of participants enrolled and who achieved PASI-50 and entered the observation follow-up phase.||||||
2800679|NCT00521339|Secondary|Time to Achieve PASI-75 During Treatment Phase|Time to achieve PASI-75 during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-75 was not analyzed, due to the small number of participants enrolled and who achieved PASI-75.||||||
2800680|NCT00521339|Secondary|Time to Clinically Relevant Response (Time to Achieve PASI-50) During Treatment Phase|Time to clinically relevant response (time to achieve PASI-50) during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-50 was not analyzed since the study enrolled a small number of participants and the number of participants who achieved PASI-50 was even smaller.||||||
2800681|NCT00521339|Secondary|Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) Involvement at Week 12|The BSA estimate was based on the palm area of the hand of the participant which equates to 1% of the total body surface area.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||Percent change in BSA||Standard Deviation|Mean
2800682|NCT00521339|Secondary|Maximal PASI Response Documented for Each Participant During Treatment Phase|PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline to Week 12|Maximal PASI response was not analyzed since similar information was captured in change in psoriasis area severity Index (PASI) score at Day 85, which is week 12.||||||
2800683|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-50 Score at Week 12|PASI -50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||percentage of participants||95% Confidence Interval|Number
2800684|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-75 Score at Week 12|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.|||percentage of participants||95% Confidence Interval|Number
2800685|NCT00521339|Secondary|Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12|The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||percent change||Standard Deviation|Mean
2800686|NCT00521339|Secondary|Percentage of Participants With at Least a 1 Point Reduction on 0 to 5 Point Scale From Baseline in Static Physician Global Assessment (sPGA) at Week 12|The static Physician's Global Assessment (sPGA) rated the investigator's overall clinical assessment of a participants plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Decreases in sPGA correspond to clinical improvement.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last Observation Carried Forward.|||percentage of participants||95% Confidence Interval|Number
2800687|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Treatment Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.~Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event."|Week 0 to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.|||participants|||Number
2800688|NCT00521144|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|Every 6 weeks, assessed up to 30 days|Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.|||participants|||Number
2800689|NCT00521079|Secondary|Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)|To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.|Baseline and 1 Year||||Percentage of subjects|||Number
2800690|NCT00521079|Primary|Rate of System and Procedure-related Serious Adverse Events (SAEs).|To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.|1 Year||||Events|||Number
2800691|NCT00521079|Primary|Percentage of Excess Weight Loss (EWL) With the Maestro System|Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)|Baseline and 1 Year||||Percentage of excess weight loss||Standard Error|Mean
2800692|NCT00521053|Secondary|Overall Survival|1-year survival|52 weeks|ITT participants|||percentage of participants|||Number
2800693|NCT00521053|Post-Hoc|Rate of Complete Response|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Complete Response Rate (CRR) = %CR.|52 weeks|ITT participants having all baseline disease injected with PV-10|||percentage of participants||95% Confidence Interval|Number
2800694|NCT00521053|Secondary|Progression Free Survival (PFS)|Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.|52 weeks||||Months||95% Confidence Interval|Median
2800695|NCT00521053|Secondary|Objective Response Rate of Untreated Bystander Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants having at least one uninjected dermal bystander lesion designated at baseline (some ITT participants did not have at least one bystander lesion).|||percentage of participants||95% Confidence Interval|Number
2800696|NCT00521053|Primary|Objective Response Rate (ORR) of PV-10 Treated Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants|||percentage of participants||95% Confidence Interval|Number
2801550|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2800699|NCT00521001|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from registration to the earliest date documentation of disease progression; Up to 5 years||||months||95% Confidence Interval|Median
2800700|NCT00521001|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause; Up to 5 years||||months||95% Confidence Interval|Median
2800701|NCT00521001|Primary|9-week Progression-free Survival Rate|The primary endpoint of this trial is the 9 week PFS rate. A patient is a success if they are progression free at their cycle 2 evaluation (approximately 9 weeks post registration). All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 9-week PFS rate (evaluable patients). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. If some patients are lost to follow up prior to their cycle 2 evaluation, the Kaplan-Meier method will be used to estimate the 9 week PFS rate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 9 weeks||||proportion of patients||95% Confidence Interval|Number
2800702|NCT00520975|Other Pre-specified|VEGF Levels in Breast Tumor by Immunohistochemistry Assay (Tumor Sample Has Not Been Analyzed Yet, no Results Could be Reported)|Tissue sections from the primary or metastatic paraffin blocks were subjected to VEGF immunohistochemistry (IHC). The VEGF cytoplasmic staining intensity was evaluated semiquantitavely using a classification from 0 to 3, with 0 representing lack of staining, 1 = low staining intensity, 2 = intermediate staining intensity and 3 = strong staining intensity. The fraction of positively staining cells will be determined as well (0 = lack of staining, 1 ≤ 1% cell staining, 2 = 1 - 10% cell staining, 3 = 10 - 50% cell staining, 4 = 50 - 90% cells staining and 5 ≤ 90% cells staining) (48). Staining intensity score zero and fraction of positively staining cells of ≤ 1% (scores zero and 1) will be considered as absence of staining and therefore negative overexpression of VEGF.|assessed at baseline|||||||
2800703|NCT00520975|Other Pre-specified|Number of Circulating Tumor Cells at Baseline|Number of circulating tumor cells per 7.5mL blood were counted prior to starting protocol therapy|assessed at baseline prior to starting protocol therapy|Patients who had blood sample drawn at baseline prior to starting protocol therapy|||number of cells per 7.5 mL blood||Full Range|Median
2800704|NCT00520975|Other Pre-specified|Change in Level of Experiencing Side Effects Between Baseline and Cycle 6 Induction|Participants indicated their level of experiencing side effects across 1 item (Functional Assessment of Cancer Therapy [FACT] item G5) on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 4 with a higher score representing better quality of life (QOL).|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their level of experiencing side effects using FACT item G5 at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
2800705|NCT00520975|Other Pre-specified|Change in Neurotoxicity Level Between Baseline and Cycle 6 Induction|Participants indicated their level of neurotoxicity symptoms across 4 items using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient ranged from 0 to 16 with higher scores representing fewer neurotoxic symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their neurotoxicity level using FACT/GOG-Ntx scale at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
2800706|NCT00520975|Other Pre-specified|Change in FACT/NCCN Breast Symptom Index (FBSI) Between Baseline and Cycle 6 Induction|Participants indicated their level of breast symptoms across 8 items using the Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) FBSI scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 32 with higher scores representing fewer symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
2800707|NCT00520975|Other Pre-specified|Change in Fatigue Level Between Baseline and Cycle 6 Induction|Fatigue level was measured using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue subscale. Participants indicated their level of fatigue across 13 items, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient was calculated by taking the reverse of each item (unless specified not to), taking the sum of those items, multiplying the sum by the number of items in the scale, and then dividing that number by the number of answered items. Total score ranged from 0 to 52 with higher scores representing less fatigue.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction|||scores on a scale||Full Range|Median
2800708|NCT00520975|Secondary|Number of Patients Experiencing Congestive Heart Failure|Clinical congestive heart failure (CHF) was assessed using Left Ventricular Ejection Fraction (LVEF) and symptom information via the Cardiac Toxicity Form as well as symptom information collected via the Adverse Event Form. Clinical CHF was defined as symptomatic decline in LVEF to below the lower limit of normal (LLN) or symptomatic diastolic dysfunction.|assessed every 3 months while on treatment and at 3 months post treatment|All patients who began protocol treatment|||participants|||Number
2800823|NCT00520130|Secondary|Overall Survival|Time between the first day of transplant to the day of death.|Patients were followed for an average of up to 5 years.|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Months||95% Confidence Interval|Median
2800709|NCT00520975|Secondary|Overall Response Rate|Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|assessed at baseline, every 12 weeks while on treatment, then very 3 months if patient is <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years from study entry until disease progression|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2800710|NCT00520975|Secondary|Proportion of Progression-free at 6 Months|Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Proportion of progression-free at 6 months was calculated using the Kaplan-Meier method.|assessed at baseline, at 3 and 6 months after study entry|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2800711|NCT00520975|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. Kaplan-Meier method was used to estimate the median OS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients|||Months||95% Confidence Interval|Median
2800712|NCT00520975|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as time from date of randomization to first disease progression, new second breast primaries, or to death from any cause, whichever occurred first, otherwise cases were censored at date last documented to be free of progression. Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the median PFS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients|||Months||95% Confidence Interval|Median
2800713|NCT00520936|Secondary|Pharmacogenomics - Measure the Response of Genes Related to Toxicity|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.|baseline|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here.|||Correlation coefficient|||Number
2800714|NCT00520936|Secondary|Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug|AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.|every cycle (up to 2 years and 7 months)|All treated participants.|||Participants|||Number
2800715|NCT00520936|Primary|Percentage of Participants With Overall Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100.|baseline to measured progressive disease (up to 1 year)|All treated participants.|||Percentage of Participants|||Number
2800716|NCT00520910|Primary|8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit||24 hours|Although data for this outcome measure was collected, however, data are not available. The PI is retired and no longer works in the organization. Sincere efforts were made to obtain the data, however, no data are available for this outcome. Department chair has assume responsibility for this record.||||||
2800717|NCT00520910|Primary|Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample|CD is determined by semiquantitative real-time polymerase chain reaction.|baseline, 24 hours|2 excluded from final data (no detectable baseline common deletion values).|||percent change||Standard Deviation|Mean
2800718|NCT00520884|Primary|Max Change Active Ghrelin|Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.|180 minutes|Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.|||pg/mL||Standard Deviation|Mean
2800719|NCT00520884|Primary|Max Change Total Ghrelin|Maximum total ghrelin change from baseline to 180 minutes|180 minutes|Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.|||pg/mL||Standard Deviation|Mean
2800720|NCT00520884|Primary|Max Change Growth Hormone|Maximum growth hormone level change from baseline to 180 minutes|180 minutes|Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.|||ng/mL||Standard Deviation|Mean
2800721|NCT00520884|Primary|Kilocalories Consumed|Kilocalorie consumption from meal of standardized composition during the visit when infusion complete|After infusion|Per protocol, primary analysis combined healthy and frail groups. The study was not powered to make statistical comparisons between the healthy and frail groups. Therefore, we are providing combined data per our protocol.|||Kilocalorie||Standard Deviation|Mean
2800722|NCT00520845|Other Pre-specified|Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry||At 1 year|data is not available. no analysis done||||||
2800723|NCT00520845|Other Pre-specified|Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane||At 1 year|data is not available. no analysis done||||||
2800724|NCT00520845|Secondary|Time to Progression|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.|||days||95% Confidence Interval|Median
2800725|NCT00520845|Secondary|Overall Response Rate|Overall response rate is measured by complete response + partial response. Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On‐treatment date to date of disease progression (assessed at 6 weeks up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.|||participants||95% Confidence Interval|Number
2800726|NCT00520845|Primary|Median Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2800727|NCT00520767|Secondary|Overall Hematologic Response Rate (OHR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.|||||||
2800728|NCT00520767|Secondary|Toxicity, Including Neurotoxicity||Day 1 of Each Cycle|||||||
2800729|NCT00520767|Secondary|Organ Response Rate (OrR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.|||||||
2800730|NCT00520767|Secondary|Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire.||At the start of each cycle|||||||
2800731|NCT00520767|Secondary|Time to Treatment Failure||Day 1 of Each Cycle|||||||
2800732|NCT00520767|Secondary|Overall Survival||Day 1 of Each Cycle and every 12 weeks after last treatment cycle|||||||
2800733|NCT00520767|Primary|Complete Hematologic Response||Up to 12 months|Individuals evaluable for response|||participants|individuals||Number
2800734|NCT00520741|Secondary|Patient's Global Impression of Change (PGIC) From Baseline To Last Visit|"For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following:~Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).|||participants|||Number
2800735|NCT00520741|Secondary|Clinical Global Impression of Change (CGIC) From Baseline To Last Visit|"For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).|||participants|||Number
2800736|NCT00520741|Secondary|Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)|Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.|Visit 9 - Visit 12 (approximately 10 weeks)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.|||days||Full Range|Median
2800737|NCT00520741|Secondary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period|"Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:~Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis~Withdrawal due to AE with onset during the Maintenance Phase~Withdrew prematurely due to lack of efficacy during the Maintenance Phase~The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.~The secondary analysis is only conducted on the Lacosamide 400 mg/day group."|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).|||percentage of subjects|||Number
2800738|NCT00520741|Secondary|Time to First Occurrence of Any Exit Event During The Maintenance Period|The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.|||days||Full Range|Median
2800739|NCT00520741|Primary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)|"Pre-defined exit criteria:~A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase~A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.~Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion~Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization~A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation~Status epilepticus, or new onset of serial/cluster seizures"|16 Weeks Maintenance Period (approximately 112 days)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).~The primary analysis is only conducted on the Lacosamide 400 mg/day group."|||percentage of subjects|||Number
2800740|NCT00520676|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.|||participants|||Number
2800741|NCT00520676|Secondary|Survival Without Grade 4 Toxicity|Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||participants||95% Confidence Interval|Median
2800742|NCT00520676|Secondary|Survival Without Clinically Important Grade 3 or 4 Toxicity|Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
2800743|NCT00520676|Other Pre-specified|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.|||months||95% Confidence Interval|Median
2800744|NCT00520676|Secondary|Percentage of Participants With Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.|||percentage of participants||95% Confidence Interval|Number
2800766|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.|||mg/L||Standard Deviation|Mean
2800746|NCT00520676|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
2800747|NCT00520676|Primary|Survival Without Grade 3 or 4 Toxicity|"Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.~Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact."|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.|||months||95% Confidence Interval|Median
2800748|NCT00520572|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).|Baseline to 6 months||||Composite score||Standard Deviation|Mean
2800749|NCT00520572|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 6 months' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).|Baseline to 6 months||||Composite score||Standard Deviation|Mean
2800750|NCT00520572|Secondary|American College of Rheumatology 70 Response (ACR70) at 6 Months|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment|6 months||||Participants|||Number
2800751|NCT00520572|Secondary|American College of Rheumatology 50 Response (ACR50) at 6 Months|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment.|6 months||||Participants|||Number
2800752|NCT00520572|Primary|American College of Rheumatology 20 Response (ACR20) at 6 Months|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment|6 months||||Participants|||Number
2800753|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions <=5mm.|within < 2 weeks after PET/MRI|lesion based (malignant lesions >5mm, n=98) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)|||lesions|Participants||Number
2800754|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)|PET positive lesions in patients with Gleason >6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative & positive predictive values were determined.|within < 2 weeks after PET/MRI|"lesion based (patients with Gleasons Score >6(3+3),n= 43) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38).~Gleason Grades: 1+2=well differentiated (rare), 3=moderately diff., 4=poorly diff., 5=undifferentiated~Gleason Score = histological primary grade + secondary grade (min=2,max=10)"|||lesions|Participants||Number
2800755|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients|PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.|within < 2 weeks after PET/MRI|Comparison of lesion based (128)imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients = 38).|||lesions|Participants||Number
2800767|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.|||mg/L||Standard Deviation|Mean
2800756|NCT00520546|Primary|Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.|within < 2 weeks after PET/MRI|Comparison of imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients).|||participants|||Number
2800757|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)|The SDS comprised all treated patients.|||participants|||Number
2800758|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).|At Weeks 12 and 25|The SDS comprised all treated patients.|||participants|||Number
2800759|NCT00520494|Secondary|Rate of Local Reactions by Severity and Relatedness|"The rate was the number of local reactions over the number of infusions administered.~Local reactions included:~infusion site: erythema, pain, pruritus, rash, reaction, swelling;~injection site: bruising, erythema, irritation, pruritus, swelling;~edema peripheral;~tenderness;~erythema;~pruritus; and~skin swelling.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.|||local reactions per infusion|Participants||Number
2800760|NCT00520494|Secondary|Number of Patients With Local Reactions by Severity and Relatedness|"Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.|||participants|||Number
2800761|NCT00520494|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.|||AEs per infusion|Participants||Number
2800762|NCT00520494|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The Safety data set (SDS) comprised all treated patients.|||participants|||Number
2800763|NCT00520494|Secondary|Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)|The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the CHQ-PF50 questionnaire were available.|||units on a scale||Standard Deviation|Mean
2800764|NCT00520494|Secondary|Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)|The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the SF-36 questionnaire were available.|||units on a scale||Standard Deviation|Mean
2800773|NCT00520494|Secondary|Overall Rate of Infections|"Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days.~Infections were classified as all AEs with the system organ class infections and infestations."|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||infections per patient year|Participants|95% Confidence Interval|Number
2800774|NCT00520494|Secondary|IgG Increase (Change From Baseline) on Day 12||Baseline to Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which IgG results, as required for the analysis, were available.|||g/L||Standard Deviation|Mean
2800775|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26||On Day 26|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||proportion of participants||95% Confidence Interval|Number
2800776|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19||On Day 19|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.|||proportion of participants||95% Confidence Interval|Number
2800777|NCT00520481|Secondary|Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks||Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only)|Participants who received study drug and had evaluable PK samples for Cmax on Cycle 1 only in 10 mg/kg group.|||µg/ml||Geometric Coefficient of Variation|Geometric Mean
2800778|NCT00520481|Secondary|Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks||Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only)|Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule.||||||
2800779|NCT00520481|Secondary|Progression-Free Survival (PFS) Rate at 6 Months|PFS rate was the proportion of participants who had stable disease (SD), PR, or CR and were alive at 6 months after receiving their first dose of study medication. Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in sum of longest diameter of target lesions, and SD was defined as shrinkage or increase in tumor size that did not meet the above criteria. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. Percentage of participants = (Number of participants with PFS at 6 months / total number of participants analyzed) *100.|From randomization up to 48.6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg - 7; Cixutumumab 20 mg/kg = 2.|||percentage of participants||95% Confidence Interval|Number
2800780|NCT00520481|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate|Percentage of participants with a PSA decrease of at least 50% from baseline PSA provided the participant had a PSA value of at least 2 nanograms per milliliter (ng/ml) at baseline. Percentage calculated as: (number of participants with PSA response rate / total number of participants) *100.|From Randomization up to 6.21 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2800781|NCT00520481|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate)|Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of longest diameter of target lesions|From Randomization up to progressive disease (49.2 months)|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2800782|NCT00520481|Secondary|Time to Radiographically Evident Disease Progression|This is the time between first dose and radiographic progression defined as either: progression of measurable or non measurable lesions using the RECIST v 1.0, evidence of progression by bone scan or new skeletal event including new pathologic bone fracture, new bone lesion requiring radiation or surgery, or spinal cord/nerve root compression. Participants without evidence of disease progression at the date of latest tumor or bone radiograph were censored.|From first dose of study drug until radiographic progression (up to 48.6 months)|ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg = 9; Cixutumumab 20 mg/kg = 2.|||months||95% Confidence Interval|Median
2800783|NCT00520481|Secondary|Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs)|Clinically significant events were defined as SAEs and other non-serious adverse events AEs. Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|From randomization up to 49.2 months (and 30 day follow-up)|Safety population: All participants who received any dose of Cixutumumab.|||Participants|||Count of Participants
2800784|NCT00520481|Primary|Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks||Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h post dose for Cycle 4; predose and 1 h postdose for Cycles 5 to 9)|Participants who received study drug and had evaluable pharmacokinetic (PK) samples for Cmax on Cycle 1 and Cycle 5.|||micrograms/milliliter (µg/ml)||Geometric Coefficient of Variation|Geometric Mean
2800785|NCT00520481|Primary|Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks||Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h postdose for Cycle 4; predose and 1 h post dose for Cycles 5 to 9)|Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule.||||||
2800824|NCT00520130|Secondary|Days to Engraftment of Lymphocytes|Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3).|2 years|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Days||Full Range|Median
2800786|NCT00520481|Primary|Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab|cTTP was the time from the first day of treatment to the earliest onset of 1 of the following: tumor progression by Response Evaluation Criteria In Solid Tumors [RECIST, version 1.0] criteria: unequivocal evidence of progression by bone scan, new skeletal events, symptomatic progression (for participants without measurable disease), or other clinical events attributable to prostate cancer that in the opinion of the investigator require major interventions. Participants without tumor progression at data cut-off were censored.|From first dose of study drug until progressive disease (Up to 49.2 months)|ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg =7; or Cixutumumab 20 mg/kg = 2.|||months||95% Confidence Interval|Median
2800787|NCT00520468|Primary|Number of Participants With Response|Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response.|Response evaluation within first 3 months from start of therapy, then every 3 to 6 months|All treated patients on study included in analysis.|||participants|||Number
2800788|NCT00520403|Primary|PFS - Time to Event|PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method|Days 0, 91, 182, 273, 365, 456, and 547|ITT population.|||days||Standard Error|Median
2800789|NCT00520403|Secondary|Overall Survival (OS)|OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.|Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)|Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed.|||weeks||Full Range|Median
2800790|NCT00520403|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.|Baseline and Cycles 3, 6, 9, 13, and 17|ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit.|||percentage of participants|||Number
2800791|NCT00520403|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.|Days 0, 91, 182, 273, 365, 456, and 547|Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication.|||percentage of participants|||Number
2800792|NCT00520351|Primary|Subjective Comfort Rating|Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.|2 weeks||||Units on a scale||95% Confidence Interval|Mean
2800793|NCT00520351|Primary|In-vivo Wettability|Pre-lens non-invasive tear breakup time|2 weeks||||Seconds||95% Confidence Interval|Least Squares Mean
2800794|NCT00520351|Primary|Low Contrast Visual Acuity|"Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.~10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks|Analysis was per protocol|||logMAR||Standard Deviation|Mean
2800795|NCT00520351|Primary|High Contrast Visual Acuity|"High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.~10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks||||logMAR||Standard Deviation|Mean
2800796|NCT00520299|Secondary|Correlation Between ASS Tumor Expression and Clinical Response|Expression of ASS was analyzed by immunohistochemistry in tumor samples (archived or biopsy) at baseline and compared with overall best clinical response per RECIST. ASS tumor expression is categorized as either negative or ≤ 5% positive tumor cells.|Up to 12 months|Includes all subjects who had an ASS antigen assay performed at Baseline|||participants|||Number
2800797|NCT00520299|Secondary|Summary of ADI-PEG 20 Immunogenicity Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for detection of anti-ADI antibodies.|Up to 12 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||log 10 U/mL||Standard Deviation|Mean
2800798|NCT00520299|Secondary|Summary of Plasma Citrulline Levels Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma citrulline levels.|Up to 9 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||uM||Standard Deviation|Mean
2800799|NCT00520299|Secondary|Summary of Plasma Arginine Levels Over Time|Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma arginine levels.|Up to 9 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||uM||Standard Deviation|Mean
2800800|NCT00520299|Secondary|Summary of ADI-PEG 20 Plasma Concentrations Over Time|Blood samples were collected on day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for ADI-PEG 20 plasma concentrations.|Up to 12 months|Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which >1 subject in any arm contributed data.|||nM||Standard Deviation|Mean
2800801|NCT00520299|Secondary|Metabolic Tumor Response|Metabolic tumor responses were evaluated using fluorodeoxyglucose (FDG) positron emission tomography (PET) at baseline, on day 4, and at the end of every cycle.|Every 8 to 9 weeks for up to 12 months|Includes all subjects who completed the study as planned or had tumor progression during the study|||participants|||Number
2800802|NCT00520299|Primary|Best Overall Clinical Tumor Response|Clinical tumor responses were evaluated using disease imaging (CT preferred) performed at baseline and at the end of every cycle. Responses were categorized according to RECIST. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Every 8 to 9 weeks for up to 12 months|Includes all subjects who completed the study as planned or had tumor progression during the study|||participants|||Number
2800803|NCT00520299|Primary|Assessment of Safety and Tolerability of ADI-PEG 20|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.|Every 1 to 2 weeks for up to 12 months|Safety Analysis Set (all subjects who received at least 1 dose of ADI-PEG 20)|||participants|||Number
2800804|NCT00520286|Secondary|Reduction of Craving|Number of subjects with 21 or more consecutive days of abstinence|21 days||||Participants|||Count of Participants
2800805|NCT00520286|Primary|Abstinence (Week 1 - 12)|Number of participant who abstained from methamphetamine from weeks 1 through 12|Weeks 1 - 12||||Participants|||Count of Participants
2800806|NCT00520234|Secondary|Subjects With 1 or More Serious Drug-related Adverse Event(s)||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.|||participants|||Number
2800807|NCT00520234|Secondary|Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.|||participants|||Number
2800808|NCT00520234|Secondary|Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.||Hospital discharge|||||||
2800809|NCT00520234|Secondary|Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.||Within 14 days after end of therapy|||||||
2800810|NCT00520234|Secondary|Time to Beta Glucan Negativity in Pre-emptive Phase.||Within 14 days after end of therapy|||||||
2800811|NCT00520234|Secondary|Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.||Within 7 days after end of therapy|||||||
2800812|NCT00520234|Secondary|Time to Development of Proven or Probable Invasive Candidiasis||Within 7 days after end of therapy|||||||
2800813|NCT00520234|Secondary|Initiation of Other Antifungals||Within 7 days after end of therapy|||||||
2800814|NCT00520234|Secondary|All Cause Mortality||Within 7 days of end of therapy|||||||
2800815|NCT00520234|Secondary|Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.||Within 7 days of end of therapy|||||||
2800816|NCT00520234|Primary|Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.|Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.|Within 7 days after end of therapy|Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.|||percent of participants|||Number
2800817|NCT00520130|Secondary|Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations|Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, 1, 3, 6, 12 and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.|||Cells/µl||Full Range|Median
2800818|NCT00520130|Secondary|Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations|Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, and 1, 3, 6, 12 and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.|||Cells/µl||Full Range|Median
2800819|NCT00520130|Secondary|Immune Reconstitution of Normal Killer (NK) Cells|Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.|2 weeks, and 1, 3, 6, 12, and 24 months post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.|||Cells/µl||Full Range|Median
2800820|NCT00520130|Secondary|Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant|During depletion of lymphocytes during transplant conditioning, levels of homeostatic cytokines increase in the blood. These then decline with the expansion of new donor-derived cells. The rapidity of decline may predict acute graft versus host disease (AGVHD). Decline in cytokine IL-7 will be assessed by the enzyme-linked immunosorbent assay (ELISA).|Day 0, 1 week and 2 weeks|Following the focus on chronic graft-versus host disease (GVHD) as a primary outcome measure in 2011, this measure was not assessed.||||||
2800821|NCT00520130|Secondary|Percentage of Participants With Late Treatment Related Mortality|Any death occurring 28 days or more after transplantation in a patient in continuous remission.|Greater than 28 days after transplantation|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
2800825|NCT00520130|Secondary|Days to Engraftment of Platelets|Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support|2 years|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Days||Full Range|Median
2800826|NCT00520130|Secondary|Days to Engraftment of Neutrophils|Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3).|2 years|One myeloma patient had graft failure in the AC Arm. 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||Days to neutrophil engraftment||Full Range|Median
2800827|NCT00520130|Secondary|Toxicities|Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|103 months and 22 days||||participants|||Number
2800828|NCT00520130|Secondary|Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD)|Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.|6 months|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
2800829|NCT00520130|Primary|Changes in CD8 T Cell Receptor Vbeta Repertoire|Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.|Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant|The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.|||Divergence index||Full Range|Median
2800830|NCT00520130|Primary|Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire|Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.|Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant|The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.|||Divergence index||Full Range|Median
2800831|NCT00520130|Primary|Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells|The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry.|Recipient recovery at 6, 12 and 24 months post transplant|A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.|||% of naive (CCR7+CD45RA+) CD8 Cells||Full Range|Median
2800832|NCT00520130|Primary|Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells|The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry.|Recipient recovery at 6, 12 and 24 months post transplant|A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.|||% of naive (CCR7+CD45RA+) CD4 Cells||Full Range|Median
2800833|NCT00520130|Primary|Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD)|Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria.|2 years post transplant|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
2800834|NCT00520130|Primary|Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD)|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.|6 months|2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.|||percentage of participants||95% Confidence Interval|Number
2800835|NCT00520039|Secondary|Change in Middle Ear Effusion Immediately After OMM at Study Visit 3|"For this study, the tympanogram was chosen to measure middle ear effusion. For the SC+OMT Group during study visit 3, three tympanogram readings from each ear included in the study were taken prior to, and immediately after the intervention. The tympanograms were sent to the blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed between normal and abnormal from before and after the OMM was computed."|Before and immediately after OMM at study visit 3||||ears|ears||Number
2800836|NCT00520039|Secondary|Change in Middle Ear Effusion Immediately After OMM at Study Visit 2|"For this study, the tympanogram was chosen to measure middle ear effusion. For the SC+OMT Group during study visit 2, three tympanogram readings from each ear included in the study were taken prior to, and immediately after the intervention. The tympanograms were sent to the blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed between normal and abnormal from before and after the OMM was computed."|Before and immediately after OMM at study visit 2||||ears|ears||Number
2800837|NCT00520039|Primary|Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media|"For this study, the tympanogram was chosen to measure middle ear effusion. Three tympanogram readings from each ear included in the study were taken at the beginning of each of 5 Study Visits. For the intervention group, a second set of 3 tympanograms was taken immediately after the OMM on Visits 1, 2 and 3. All tympanograms were sent to a blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed from baseline over 4 weeks was computed by crosstabulating the intervention group by the normal/abnormal changes in tympanograms."|1 month|4 ears, from 2 subjects, were removed from the SC+OMM group final analysis due to no interpretable readings obtained during the study.|||Ears|Ears||Number
2800838|NCT00520013|Secondary|Consolidation Objective Response Rate|Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.|The analysis dataset is comprised of all patient who started consolidation treatment.|||proportion of patients||95% Confidence Interval|Number
2800839|NCT00520013|Primary|Consolidation Treatment-related Toxicity Rate|Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.|Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.|The analysis dataset is comprised of patients who were randomized to consolidation treatment.|||percentage of participants||95% Confidence Interval|Number
2800840|NCT00520013|Primary|Consolidation Progression-Free Survival|Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to >/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.|The analysis dataset is comprised of patients randomized to consolidation treatment.|||months||95% Confidence Interval|Median
2800841|NCT00519896|Secondary|Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|At 30 days from the last dose of study treatment and then for 2 years||||months||95% Confidence Interval|Median
2800842|NCT00519896|Secondary|Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0|Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.|On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years|All patients that received at least one dose of sunitinib malate were included in the analysis.|||participants|||Number
2800843|NCT00519896|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,"|At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||Participants|||Count of Participants
2800844|NCT00519831|Secondary|Progression-free Survival||after cycle 2, within 2 weeks of completing cycle 4|Data not collected due to early study termination.||||||
2800845|NCT00519831|Secondary|Overall Survival||Every 30 days|Data not collected due to early study termination.||||||
2800846|NCT00519831|Secondary|Duration of Response||After cycle 4|Data not collected due to early study termination.||||||
2800873|NCT00519584|Secondary|Maximum VRS Pain Scores at Rest|Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.|postoperative day 1 day 2, day 3.||||units on a scale||Inter-Quartile Range|Median
2800847|NCT00519831|Primary|Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.|Baseline, after cycle 2, within 2 weeks of completing cycle 4||||Participants|||Count of Participants
2800848|NCT00519818|Secondary|17 Hydroxyprogesterone at 08.00 Hours||Cortef after one week compared with Chronocort after one month||||nmol/l||Standard Deviation|Mean
2800849|NCT00519818|Primary|Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).||Cortef after one week, Chronocort after one month|Per protocol|||h*nmol/l||Standard Error|Mean
2800850|NCT00519779|Secondary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score~The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||scores on a||Standard Error|Least Squares Mean
2800851|NCT00519779|Primary|Stimulated ln(TNF-alpha)|log-transformed stimulated TNF-alpha|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
2800852|NCT00519779|Primary|Stimulated ln(IL-6)|"log-transformed stimulated IL-6~Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.~Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intent to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
2800853|NCT00519779|Primary|Serum ln(TNF-a)|"log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)~All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
2800854|NCT00519779|Secondary|ln(Beck Anxiety Score)|log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||units||Standard Error|Least Squares Mean
2800855|NCT00519779|Primary|Serum ln(IL-6)|"log-transformed serum Interleukin-6 (IL-6)~Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.~Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat|||ln(pg/mL)||Standard Error|Least Squares Mean
2800856|NCT00519649|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|After the challenge dose of HBV vaccine.||||Participants|||Count of Participants
2800857|NCT00519649|Secondary|Number of Participants Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of HBV vaccine.||||Participants|||Count of Participants
2800858|NCT00519649|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache|During the 4-day follow-up period after the challenge dose of HBV vaccine.||||Participants|||Count of Participants
2800859|NCT00519649|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling|During the 4-day follow-up period after the challenge dose of HBV vaccine.||||Participants|||Count of Participants
2800860|NCT00519649|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL|Before challenge dose of HBV vaccine|Analysis was performed on subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point|||Participants|||Count of Participants
2800861|NCT00519649|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)|One month after the challenge dose of HBV vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity|||Participants|||Count of Participants
2800874|NCT00519584|Secondary|Time to a Significant Increase in Shoulder Discomfort|the length of time until the patients' first report of surgical site pain.|during postoperative day 1 to 3||||hours||Inter-Quartile Range|Median
2800875|NCT00519584|Primary|the Duration of Analgesia|the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain|surgical date to postoperative day 1 (pod 0 -1 day)||||hours||Inter-Quartile Range|Median
2800862|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist|"Subjects assessed preference over gentleness of mist for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2800863|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use|"Subjects assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2800864|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat|"Subjects assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2800865|NCT00519636|Secondary|Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
2800866|NCT00519636|Secondary|Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population. A subject in the FP/FF group had no baseline daytime TNSS; however, does have a baseline nighttime TNSS, that value serves as the baseline 24-hour TNSS. Therefore there are 90 24-hour & nighttime TNSS observations available in the FP/FF group, but only 89 daytime TNSS observations.|||Scores on a scale||Standard Error|Mean
2800867|NCT00519636|Primary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.|||Participants|||Number
2800868|NCT00519636|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.|||Scores on a scale||Standard Error|Mean
2800869|NCT00519623|Primary|Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.|Glucose infusion rates were adjusted every 10 minutes as necessary||||mg/kg/min||Standard Error|Mean
2800870|NCT00519623|Secondary|Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients|Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.|Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal||2010-11-30|11/2010||||
2800871|NCT00519623|Primary|Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.|Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours|Number of subjects completed|||uU/mL||Standard Error|Mean
2800872|NCT00519584|Secondary|Total Opioid Consumption|cumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.|during first 3 days after surgery||||mg||Inter-Quartile Range|Median
2800876|NCT00519532|Secondary|Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)|"The change in number of nocturias was used to evaluate improvements in sleep disorders.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||Nocturias||Standard Deviation|Mean
2800877|NCT00519532|Secondary|Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)|"Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
2800878|NCT00519532|Primary|Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)|"The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
2800879|NCT00519532|Primary|Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.~Baseline is defined as first titration visit (T1) of SP915."|Baseline (baseline SP915) and week 13 (End of maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
2800880|NCT00519428|Secondary|Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).~The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction."|12 weeks|All Randomized Subjects|||units on the Q-LES-Q scale||Standard Deviation|Mean
2800881|NCT00519428|Secondary|Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|12 weeks|All randomized patients; latest available Total SAS score used if week 12 score not available.|||units on the SAS scale||Standard Deviation|Mean
2800882|NCT00519428|Secondary|Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)|"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|12 weeks|age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.|||units on Hamilton Rating Scale for Depre||Standard Deviation|Mean
2800883|NCT00519428|Secondary|Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12|Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate.|12 weeks|age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.|||percentage of participants|||Number
2800884|NCT00519428|Primary|Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7|Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05.|12 weeks|age 18-65 with Major Depressive Disorder (MDD), non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate selective serotonin re-uptake inhibitor (SSRI) and/or bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.|||weeks||Standard Deviation|Mean
2800885|NCT00519376|Secondary|Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed|||Hours||Full Range|Median
2800917|NCT00519285|Secondary|Prostate Specific Antigen Response Rate|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response.|Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for PSA response (i.e. with a baseline PSA ≥10 ng/mL).|||percentage of participants||95% Confidence Interval|Number
2800886|NCT00519376|Secondary|Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed|||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2800887|NCT00519376|Secondary|AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed|||picograms.Hour/milliliter (pg.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2800888|NCT00519376|Secondary|Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium|Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter [mL]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Millimoles per liter (mmol/L)||Standard Error|Mean
2800889|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure|Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Millimeters of mercury||Standard Error|Mean
2800890|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate|Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Beats per minute||Standard Error|Mean
2800891|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F).|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Milliseconds (msec)||Standard Error|Mean
2800892|NCT00519376|Secondary|Mean FEV1 Over 23 and 24 Hours After Dosing|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects .|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Mean
2800893|NCT00519376|Primary|Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period|ECG parameters [PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PP Population.|||milliseconds (msec)||Standard Deviation|Mean
2800894|NCT00519376|Primary|Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period|Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Per Protocol (PP) Population: all participants included in the All Subjects population excluding a participant deemed not to have heart rate or other ECG parameters deemed suitable for evaluation. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Beats per minute(bpm)||Standard Deviation|Mean
2800895|NCT00519376|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period|SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2800896|NCT00519376|Primary|Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Milligrams per liter (Mg/L)||Standard Deviation|Mean
2800897|NCT00519376|Primary|Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2800898|NCT00519376|Primary|Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2800899|NCT00519376|Primary|Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2800900|NCT00519376|Primary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2800901|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
2801551|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2800902|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
2800903|NCT00519376|Primary|Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Proportion of 1.0||Standard Deviation|Mean
2800904|NCT00519376|Primary|Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2800905|NCT00519376|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2800906|NCT00519376|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2800907|NCT00519376|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
2800908|NCT00519285|Secondary|Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept|"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.~Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).~A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits."|Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug|The analysis was performed on the safety population evaluable for immunogenicity (i.e. exposed to aflibercept with serum samples evaluable for immunogenicity).|||participants|||Number
2800909|NCT00519285|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.~AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)."|From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days|The analysis was performed on the safety population (i.e. all randomized and treated participants according to the treatment actually received). Six participants in the Placebo group who received at least one dose of aflibercept in error were considered in the Aflibercept group.|||participants|||Number
2800910|NCT00519285|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life|"Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a 39-item participant questionnaire that measures the concerns of patients with prostate cancer. It consists of 5 subscales assessing physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate-specific concerns.~FACT-P total score is the sum of the 5 subscores. It ranges from 0 to 156 with higher score indicating better quality of life."|Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first|The analysis was performed on the ITT population evaluable for Health related quality of life (i.e. with baseline and at least one post-baseline evaluable FACT-P questionnaire).|||units on a scale||Standard Deviation|Mean
2800911|NCT00519285|Secondary|Pain Response Rate|Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response.|Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first|The analysis was performed in the ITT population evaluable for pain response (i.e. stable analgesia at baseline and, baseline PPI ≥2 and/or baseline AS ≥10 points).|||percentage of participants||95% Confidence Interval|Number
2800912|NCT00519285|Secondary|Pain Progression-free Survival Time|"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.~Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.~The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population evaluable for pain progression (i.e. with no pain or with stable pain at baseline).~At the cut-off date, pain progression or death had occurred in 507 participants, 263 in the Placebo group and 244 in the Aflibercept group."|||months||95% Confidence Interval|Median
2800913|NCT00519285|Secondary|Prostate Specific Antigen Progression-free Survival Time|"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.~PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.~The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed in the ITT population evaluable for PSA progression (i.e. with an evaluable baseline PSA).~At the cut-off date, PSA progression or death had occurred in 1138 participants, 571 in the Placebo group and 567 in the Aflibercept group."|||months||95% Confidence Interval|Median
2800914|NCT00519285|Secondary|Tumor Response Rate in Participants With Measurable Disease|Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0.|Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for tumor response (i.e. received at least one dose of study drugs (aflibercept/placebo or docetaxel), had no important deviations to protocol and was evaluable for response as per RECIST version 1.0).|||percentage of participants||95% Confidence Interval|Number
2800915|NCT00519285|Secondary|Progression Free Survival Time|"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).~Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.~The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.~At the cut-off date, disease progression or death had occurred in 1184 participants, 592 in each treatment group."|||months||95% Confidence Interval|Median
2800916|NCT00519285|Secondary|Time to Skeletal Related Events|"Skeletal Related Events (SRE) included pathological fractures and/or spinal cord compression, need for bone irradiation, including radioisotopes or bone surgery, change in antineoplastic therapy to treat bone pain.~Time to SRE was defined as the time from the date of randomization to the date of occurence of the first event defining a SRE or death due to any cause, whichever occurred first.~The median time to SRE and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of SRE, the participant was censored at the last date he/she was known to be alive or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.~At the cut-off date, SRE or death had occurred in 1013 participants, 516 in the Placebo group and 497 in the Aflibercept group."|||months||95% Confidence Interval|Median
2801552|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2800918|NCT00519285|Primary|Overall Survival Time|"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.~The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the Intent-to-treat (ITT) population (i.e all randomized participants according to the treatment assigned regardless of the drug actually received).~At the cut-off date, 873 deaths had occurred, 445 in the Placebo group and 428 in the Aflibercept group."|||months||95% Confidence Interval|Median
2800919|NCT00519194|Primary|Freedom From Atrial Fibrillation in the Absence of Any AF Therapies|Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.|6 months||||participants|||Number
2800920|NCT00519090|Secondary|Durable Complete Cytogenetic Response Rate|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|24 months|The trial was terminated early, so only 6 patients were enrolled.|||percent of participants|||Number
2800921|NCT00519090|Primary|Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|12 months||||percent of participants|||Number
2800922|NCT00519077|Secondary|Median Progression-free Survival Time|Progression-free survival (PFS) is the number of months during and after Gefitinib treatment during which the cancer did not get worse (progress) as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Progressive disease is associated with at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. All patients developed progressive disease or died during the 9-month observation period.|9 months||||months||95% Confidence Interval|Median
2800923|NCT00519077|Primary|Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates|"The proportion of subjects that responded [complete (CR) or partial response (PR)], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST)~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|8 weeks|Eight patients were not assessable for response, six of them died prior to the evaluation of response. For the purpose of the analysis these patients were classified as having disease progression in response to therapy.|||percentage of participants|||Number
2800924|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of Sleepiness."|Baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800925|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of Sleepiness."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800926|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of Sleepiness."|Baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at Baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800927|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of Sleepiness."|Baseline and 2 weeks|Full analysis set defined as subjects who completed the ES Symptom Rating form at baseline and 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2801278|NCT00517751|Secondary|Oswestry Disability Index (ODI) Score|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2800928|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)|"The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of Sleepiness."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2800929|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks."|baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed MOS-CF6 at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800930|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
2800931|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks."|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800932|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks."|baseline and 2 weeks|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800933|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline)."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2800934|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.|12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 12 weeks|||Participants|||Number
2800935|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.|8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 8 weeks|||Participants|||Number
2800997|NCT00518882|Secondary|Change in Triglyceride at Week 78|Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2800936|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.|4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 4 weeks|||Participants|||Number
2800937|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.|2 weeks following start of study drug administration|Full analysis set defined as subject who completed the FOSQ at 2 weeks|||Participants|||Number
2800938|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.|Endpoint (week 12 or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline|||Participants|||Number
2800939|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.|baseline and 12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800940|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800941|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800942|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.|baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed FOSQ at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800943|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.|Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2800944|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 12 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
2801302|NCT00517595|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.||||Months||95% Confidence Interval|Median
2800945|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800946|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800947|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800948|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and at endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2800949|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.|12 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 12 weeks|||Participants|||Number
2800950|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.|8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 8 weeks|||Participants|||Number
2800951|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.|4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 4 weeks|||Participants|||Number
2800952|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.|2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 2 weeks|||Participants|||Number
2800972|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.|12 weeks after starting study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 12 weeks|||Participants|||Number
2800953|NCT00518986|Secondary|Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.|12 weeks after start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline|||Participants|||Number
2800954|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.|12 weeks||||Units on a scale||Standard Error|Least Squares Mean
2800955|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
2800956|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800957|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800958|NCT00518986|Secondary|Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).|Baseline and 12 weeks or last observation after baseline|Full analysis set defined as subjects with at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2800959|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.|Baseline and 12 weeks after start of study drug administration||||Units on a scale||Standard Error|Least Squares Mean
2800960|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.|Baseline and 8 weeks after start of study drug administration||||Units on a scale||Standard Error|Least Squares Mean
2800961|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800962|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800963|NCT00518986|Secondary|Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.|Baseline and 12 weeks following start of study drug administration or last recorded observation|Full analysis set defined as subjects with at least one BFI assessment after baseline|||Units on a scale||Standard Error|Least Squares Mean
2800964|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.|12 weeks|Full analysis set defined as subjects who completed the ESS at 12 weeks|||Participants|||Number
2800965|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.|8 weeks|Full analysis set defined as subjects who completed ESS at 8 weeks|||Participants|||Number
2800966|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.|4 weeks|Full analysis set defined as number of subjects who completed ESS at 4 weeks|||Participants|||Number
2800967|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.|2 weeks|Full analysis set defined as the number of subjects who completed the ESS at 2 weeks|||Participants|||Number
2800968|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.|12 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed ESS at Baseline and at 12 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800969|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at Baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2800970|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at baseline and at Week 4|||Units on a scale||Standard Error|Least Squares Mean
2800971|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.|Baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ESS at baseline and at 2 weeks|||Unit on a scale||Standard Error|Least Squares Mean
2800996|NCT00518882|Secondary|Change in Free Fatty Acid at Week 26|Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2800973|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.|8 weeks after start of study drug treatment|Full analysis set defined as subjects who were assessed by CGI-C at 8 weeks|||Participants|||Number
2800974|NCT00518986|Secondary|Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.|4 weeks after start of treatment|Full analysis set defined as subjects who were assessed by CGI-C at 4 weeks.|||Participants|||Number
2800975|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.|12 weeks after beginning treatment|Full analysis set defined as subjects assessed with CGI-C at week 12|||Participants|||Number
2800976|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed."|8 weeks after beginning study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 8 weeks|||Participants|||Number
2800977|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 4 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed."|4 weeks after beginning study drug treatment|Full analysis set defined as subjects who were assessed with CGI-C at 4 weeks|||Participants|||Number
2800978|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had measurements of MWT at baseline and 12 weeks.|||Minutes||Standard Error|Least Squares Mean
2800979|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects with MWT measure at 8 weeks and baseline|||Minutes||Standard Error|Least Squares Mean
2800980|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 4 weeks|Full analysis set defined as subjects who had MWT measurement at baseline and at 4 weeks|||Minutes||Standard Error|Least Squares Mean
2800981|NCT00518986|Secondary|Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)|For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had at least one assessment of ESS after baseline|||Units on a scale||Standard Error|Least Squares Mean
2801279|NCT00517751|Secondary|Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment|Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months||||percentage of participants|||Number
2800982|NCT00518986|Primary|Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) were assessed."|12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or CGI-C after baseline.|||Participants|||Number
2800983|NCT00518986|Primary|Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or Clinical Global Impression of Change (CGI-C) after baseline.|||Minutes||Standard Deviation|Mean
2800984|NCT00518973|Secondary|Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)|The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A clinical interview is conducted and patient is rated from 1 to 7 on 30 different symptoms based on the interview.|Day 1 to LOCF (up to 8 weeks)||||Units on the scale||Standard Deviation|Mean
2800985|NCT00518973|Secondary|Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)|Hamilton Depression Rating Scale (HAM-D) form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.|Day 1 to LOCF (up to 8 weeks)||||Units on the scale||Standard Deviation|Mean
2800986|NCT00518973|Secondary|Difference in Scores on the STAI (State-Trait Anxiety Inventory)|The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.|Day 1 to LOCF (up to 8 weeks)||||Units on the scale||Standard Deviation|Mean
2800987|NCT00518973|Primary|Difference in Scores on the EDI-2 (Eating Disorders Inventory)|The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears|Day 1 to LOCF (up to 8 weeks)||||Units on the scale||Standard Deviation|Mean
2800988|NCT00518973|Primary|Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)|The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.|Day 1 to LOCF (up to 8 weeks)||||Hours||Standard Deviation|Mean
2800989|NCT00518882|Secondary|Hypoglyceamic Episodes, Weeks 26-78|Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 26-78|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.|||episodes|||Number
2800990|NCT00518882|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.|||episodes|||Number
2800991|NCT00518882|Secondary|Change in Apolipoprotein B at Week 78|Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||g/L||Standard Deviation|Mean
2800992|NCT00518882|Secondary|Change in Apolipoprotein B, Weeks 26-78|Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||g/L||Standard Deviation|Mean
2800993|NCT00518882|Secondary|Change in Apolipoprotein B at Week 26|Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||g/L||Standard Error|Least Squares Mean
2800994|NCT00518882|Secondary|Change in Free Fatty Acid at Week 78|Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2800995|NCT00518882|Secondary|Change in Free Fatty Acid, Weeks 26-78|Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2800998|NCT00518882|Secondary|Change in Triglyceride, Weeks 26-78|Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2800999|NCT00518882|Secondary|Change in Triglyceride at Week 26|Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801000|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 78|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801001|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol, Weeks 26-78|Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801002|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 26|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801003|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801004|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801005|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 26|Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801006|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 78|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801007|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801008|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 26|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801009|NCT00518882|Secondary|Change in Total Cholesterol at Week 78|Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.|||mmol/L||Standard Deviation|Mean
2801010|NCT00518882|Secondary|Change in Total Cholesterol, Weeks 26-78|Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Deviation|Mean
2801011|NCT00518882|Secondary|Change in Total Cholesterol at Week 26|Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801036|NCT00518882|Secondary|Change in Body Weight at Week 78|Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||kg||Standard Deviation|Mean
2801012|NCT00518882|Secondary|Change in Beta-cell Function at Week 78|"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point (%point)||Standard Deviation|Mean
2801013|NCT00518882|Secondary|Change in Beta-cell Function, Weeks 26-78|"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point (%point)||Standard Deviation|Mean
2801014|NCT00518882|Secondary|Change in Beta-cell Function at Week 26|"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||percentage point (%point)||Standard Error|Least Squares Mean
2801015|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801016|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801017|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801018|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801019|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801020|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801021|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801022|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0. week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801362|NCT00517192|Secondary|Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.||48 weeks of treatment|||||||
2801023|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801024|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801025|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801026|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801027|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801028|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801029|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801030|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801031|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801032|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801033|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 78|Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801034|NCT00518882|Secondary|Change in Fasting Plasma Glucose, Weeks 26-78|Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||mmol/L||Standard Deviation|Mean
2801035|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||mmol/L||Standard Error|Least Squares Mean
2801037|NCT00518882|Secondary|Change in Body Weight, Weeks 26-78|Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||kg||Standard Deviation|Mean
2801038|NCT00518882|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||kg||Standard Error|Least Squares Mean
2801039|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage (%) of subjects|||Number
2801040|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||percentage (%) of subjects|||Number
2801041|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c) at Week 78|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point of total HbA1c||Standard Deviation|Mean
2801042|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c), Weeks 26-78|Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.|||percentage point of total HbA1c||Standard Deviation|Mean
2801043|NCT00518882|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
2801044|NCT00518713|Other Pre-specified|Percent Reduction of Total (Drop and Non-Drop) Seizures.|This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.|4-week baseline period and 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
2801045|NCT00518713|Other Pre-specified|Percent Reduction in the Number of Non-drop Seizures.|This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.|4-week baseline period and the 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
2801046|NCT00518713|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who had a baseline and Week 15 parent/caregiver global evaluations were analyzed.|||participants|||Number
2801047|NCT00518713|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms.|"The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who completed a Physician Global Evaluation at Week 15.|||participants|||Number
2801048|NCT00518713|Secondary|Tolerance|Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.|4-week baseline period and first 4/first 8 weeks of the maintenance period|MITT|||Participants|||Number
2801049|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period||||Percent Responders|||Number
2801050|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period||||Percent Responders|||Number
2801672|NCT00515008|Secondary|Mean Change From Baseline of 6-Minute Walk Test||12 weeks||||yards||95% Confidence Interval|Mean
2801051|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT|||Percent of responders|||Number
2801052|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 12-week maintenance period||||Percent of responders|||Number
2801053|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
2801054|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period||||Percent reduction||Full Range|Least Squares Mean
2801055|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT population|||Percent reduction||Full Range|Least Squares Mean
2801056|NCT00518713|Primary|Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 12-week maintenance period|Modified Intent-to-Treat (MITT) population|||Percent Reduction||Full Range|Least Squares Mean
2801057|NCT00518687|Secondary|Number of Participants With Surgical-site Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination|||participants|||Number
2801058|NCT00518687|Secondary|Number of Participants With Invasive Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination|||participants|||Number
2801059|NCT00518687|Primary|Incidence Rate of Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.|Up to 360 days after surgery|The population analyzed included all vaccinated participants with follow-up results|||Events per 100 person-years|||Number
2801060|NCT00518687|Primary|Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination|||participants|||Number
2801061|NCT00518622|Primary|Antiviral Activity of MK7009|Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8|Baseline and Day 8|Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.|||Log10 IU/mL HCV RNA||Standard Deviation|Mean
2801062|NCT00518622|Primary|Safety and Tolerability of MK7009|Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication|14 days after completion of study therapy|All treated patients are included in the safety analysis.|||Participants|||Number
2801363|NCT00517192|Secondary|Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).||48 weeks of treatment|||||||
2801063|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 18, Month 24 (treatment period 2)|"Participants in the PRO analysis set with at least one post-baseline assessment in both periods and with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
2801064|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 6, Month 12 (treatment period 1)|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
2801065|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Preference Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. The BMQ preference score, which measures a participant's overall evaluation of a medication, is based on the average of 7 items in the BMQ. The preference score ranges from 1 to 5, with higher scores indicating stronger preference for one medication over the other.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
2801066|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Concern Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. Participants' concern about the adverse consequences of taking the medication for controlling osteoporosis was based on the average of 10 items from the BMQ that form the concern score. The concern score ranges from 1 to 5, with higher scores indicating stronger concerns about the adverse consequences of taking the prescribed medication for controlling osteoporosis.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
2801067|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ): Necessity Score|"The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other.~Participants' beliefs about the necessity of the prescribed medication to treat osteoporosis were based on the average of 5 items from the BMQ that form the necessity score. The necessity score ranges from 1 to 5, with higher scores indicating stronger beliefs about the necessity of the prescribed medication for controlling osteoporosis."|Baseline, Month 6, Month 12, Month 18 and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."|||scores on a scale||Standard Deviation|Mean
2801068|NCT00518531|Secondary|Overall Satisfaction to Study Treatment|"Participant satisfaction with their treatment was assessed using question 7 (ie, Please rate your satisfaction with the weekly pill on the following: frequency of administration; mode of administration [taking a pill]; convenience; overall satisfaction) and question 8 (ie, Please rate your satisfaction with the six month injection on the following: frequency of administration; mode of administration [receiving an injection]; convenience; overall satisfaction) from the Preference Satisfaction Questionnaire (PSQ) at the end of each treatment period. The PSQ is a 34 item, self-report questionnaire of participants' preference and satisfaction for each of the two study treatments. Possible answers include: Not at all Satisfied, A Little Satisfied, Moderately Satisfied, Quite Satisfied, and Very Satisfied."|End of treatment period 1 (Month 12)|The Patient Reported Outcomes (PRO) analysis set for each independent treatment period included patients in the FAS who received at least one dose of study drug and had at least one post-baseline assessment in the relevant treatment period. Analysis population includes patients with observed data for ≥1 question in the questionnaire.|||Participants|||Number
2801069|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the Second Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 2 (Month 13 to Month 24)|Crossover set|||weeks||Standard Error|Mean
2801070|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the First Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||weeks||Standard Error|Mean
2801364|NCT00517192|Primary|Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.||48 weeks of treatment|||||||
2801071|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the Second Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 2 (Month 13 to Month 24)|crossover set|||weeks||Standard Error|Mean
2801072|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the First Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||weeks||Standard Error|Mean
2801073|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the Second Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 2 (Month 13 to Month 24)|Crossover set|||weeks||Standard Error|Mean
2801074|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the First Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 1 (Month 1 to Month 12)|Full analysis set|||weeks||Standard Error|Mean
2801075|NCT00518531|Secondary|Persistence With Treatment in the Second Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 2 (Month 13 to Month 24)|Crossover set|||Participants|||Number
2801076|NCT00518531|Secondary|Persistence With Treatment in the First Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||Participants|||Number
2801077|NCT00518531|Secondary|Compliance With Treatment in the Second Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 2 (Month 13 to Month 24)|Crossover set|||Participants|||Number
2801078|NCT00518531|Secondary|Compliance With Treatment in the First Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 1 (Month 1 to Month 12)|Full analysis set|||Participants|||Number
2801079|NCT00518531|Secondary|Adherence With Treatment in the Second Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed nonadherent to treatment.|Treatment period 2 (Months 13 to 24)|The cross-over analysis set includes all participants who crossed over to their treatment period 2 treatment.|||Participants|||Number
2801080|NCT00518531|Primary|Adherence With Treatment in the First Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.|Treatment period 1 (Month 1 to Month 12)|The full analysis set (FAS) includes all participants who were randomized.|||Participants|||Number
2801081|NCT00518349|Primary|Patient Assessment of Pain Experienced During Colonoscopy|"The proportion of patients reporting no pain when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet)."|Pain experienced during colonoscopy|Power estimates based on assumption of 20% difference in pain-free examination comparing groups|||participants|||Number
2801082|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801083|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801084|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801085|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801086|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801087|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801088|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801089|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801090|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801091|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801092|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801093|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801094|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801095|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801096|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801097|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801098|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801099|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801100|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801101|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801102|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801103|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801104|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801105|NCT00518336|Secondary|Number of Subjects With Medically Signifant Conditions up to Year 9|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801106|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.||Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801107|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo).|||Subjects|||Number
2801108|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||Titer||95% Confidence Interval|Geometric Mean
2801109|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL).~The cut-off-vales assessed were >= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively."|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||EL. U/mL||95% Confidence Interval|Geometric Mean
2801110|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801139|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).|At Months 77-101|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2801365|NCT00517075|Secondary|Cortical Excitability||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801111|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801112|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801113|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801114|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801115|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801116|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801117|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801118|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801119|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2829784|NCT00303823|Primary|Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer||4 months||||participants|||Number
2801120|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801121|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)|||Subjects|||Number
2801122|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801123|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801124|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801125|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801126|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801140|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801127|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study, who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801128|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801129|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801130|NCT00518336|Secondary|Number of Subjects With SAEs up to Year 8|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801131|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 7|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801132|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 8|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801133|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 7|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801134|NCT00518336|Secondary|Number of Subjects With NOAD up to Year 8|The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801135|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7||Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801136|NCT00518336|Secondary|Number of Subjects With NOCD up to Year 8|"NOCDs included for example asthma, type I diabetes, allergies, ...~NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801137|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801138|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Months 77-101|The analyses were performed on a subset of the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2801141|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801142|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801143|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801144|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801145|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801146|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801147|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801148|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801149|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2829785|NCT00303823|Primary|No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months||||participants|||Number
2801150|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801151|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)|||subjects|||Number
2801152|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801153|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801154|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801155|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||Subjects|||Number
2801156|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801157|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801158|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801159|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801160|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 8|According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.|||subjects|||Number
2801161|NCT00518323|Secondary|Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness|The sleep VAS for daytime drowsiness is a scale for measuring the drowsiness experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
2801162|NCT00518323|Secondary|Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.|The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
2801163|NCT00518323|Secondary|Change From Baseline to End Point in Children's Global Assessment (CGAS) Score|The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
2801164|NCT00518323|Secondary|Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S rating scale was used to assess the severity of a subject's overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Full Range|Median
2801165|NCT00518323|Primary|Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.|The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.|||units on a scale||Standard Deviation|Mean
2801166|NCT00518284|Secondary|Diameter Stenosis|Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percent diameter stenosis||Standard Deviation|Mean
2801167|NCT00518284|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
2801168|NCT00518284|Secondary|Late Loss|Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.|Day 1 (following revascularization) and 9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||mm||Standard Deviation|Mean
2801169|NCT00518284|Secondary|Minimum Lumen Diameter|Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||mm||Standard Deviation|Mean
2801184|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.|Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.|Days 1 to 7|The analysis was performed on the safety set.|||Subjects|||Number
2801170|NCT00518284|Secondary|Number of Participants With a Stroke|The number of patients experiencing a stroke during the study. Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage. A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.|Up to 11 months|Treated population.|||participants|||Number
2801171|NCT00518284|Secondary|Number of Participants With Myocardial Infarction (MI)|The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.|Up to 11 months|Treated population.|||participants|||Number
2801172|NCT00518284|Secondary|Number of Deaths|Number of patients who died due to any cause.|Up to 11 months|Treated population.|||participants|||Number
2801173|NCT00518284|Secondary|Target Lesion Revascularization (TLR) at 9 Months|Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage). The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
2801174|NCT00518284|Secondary|Decrease in Ankle Brachial Index (ABI) > 0.15|"The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15.~Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure."|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
2801175|NCT00518284|Secondary|Change From Baseline in Walking Impairment Questionnaire (WIQ) Score|The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient's walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||scores on a scale||Standard Deviation|Mean
2801176|NCT00518284|Secondary|Systolic Velocity Ratio (SVR) > 2.0|The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
2801177|NCT00518284|Primary|Target Vessel Revascularization at 9 Months|Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.|||percentage of participants|||Number
2801178|NCT00518206|Secondary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity was defined as any treatment-related grade 4 toxicity or any grade 3 toxicity, excluding grade 3 skin necrosis at the site of the delayed-type hypersensitivity reaction, fever, or asymptomatic hyperglycemia that improved to baseline within 3 weeks of onset.|Up to 22 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
2801179|NCT00518206|Secondary|Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine|Blood samples were drawn to measure humoral immunologic response at pretreatment and weeks 3, 7, 11, 33, and every 12 weeks thereafter. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 by enzyme-linked immunosorbent assay (ELISA). Data are presented according to baseline (BL) NY-ESO-1 antibody positivity and the time to seroconversion, if applicable.|Up to 22 months|Subjects with available measurement of baseline and post-baseline positivity for NY-ESO-1 antibodies.|||Participants|||Count of Participants
2801180|NCT00518206|Secondary|Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions|NY-ESO-1-specific DTH was measured by intradermal injection with the full-length NY-ESO-1 protein, NY-ESO-1b peptide, and NY-ESO-1 DP4 peptide at pretreatment, week 11, and between week 23 and 25. DTH reactions (eg, local skin irritation) were evaluated 2 days after DTH injections. Data presented are based on injections with the full-length peptide, as these data are considered to be representative of the comprehensive DTH results.|Up to 22 months|Subjects who underwent DTH testing with available DTH reaction evaluation(s).|||Participants|||Count of Participants
2801181|NCT00518206|Secondary|Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine|Blood samples were drawn to measure cellular response at pretreatment and weeks 3, 7, 11, between weeks 23 and 25, week 33, and every 12 weeks thereafter. Cellular immunity included an assay for gamma interferon-producing T cells and enumeration of NY-ESO-1b-specific T cells, detected by fluorescent labeled human leukocyte antigen (HLA)-A2 tetramers carrying the NY-ESO-1b peptide, expressed as percent positive staining of CD4+ and CD8+ T cells. Data are presented for CD4+ and CD8+ T-cell responses (not mutually exclusive) that were pre-existing at baseline (BL) or presented at any time post-BL.|Up to 22 months|Subjects with available results from the evaluation of T-cell responses in peripheral blood.|||participants|||Number
2801182|NCT00518206|Primary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to RECIST (version 1.0) at baseline, at week 11, between weeks 23 and 25, and every 12 weeks thereafter. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 22 months|Subjects with data available from at least 1 post-baseline response assessment.|||Participants|||Count of Participants
2801183|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination|Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.|Days 1 to 7|The analysis was performed on the safety population.|||Subjects|||Number
2829786|NCT00303823|Primary|Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months||||participants|||Number
2801185|NCT00518180|Primary|Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)|To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||IU/mL||95% Confidence Interval|Geometric Mean
2801186|NCT00518180|Secondary|Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN|To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2801187|NCT00518180|Secondary|Geometric Mean Titers (GMT) of Pertussis Antigens|To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2801188|NCT00518180|Secondary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus|To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||IU/mL||95% Confidence Interval|Geometric Mean
2801189|NCT00518180|Secondary|The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus|The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
2801190|NCT00518180|Secondary|Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups|The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
2801191|NCT00518180|Secondary|Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2801192|NCT00518180|Secondary|Percentage of Subjects With Anti-HPV Seroconversion|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
2801193|NCT00518180|Secondary|Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups|The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2801194|NCT00518180|Primary|Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL|To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.|||Percentage of subjects||95% Confidence Interval|Number
2801195|NCT00518180|Primary|Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse|"Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.~Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.|||Percentage of participants||95% Confidence Interval|Number
2801196|NCT00518154|Primary|CD4+ Cell Count Change Between Basal and Week 16 of Additive Treatment|Change in total CD4+ T-cell number from baseline to addition of pyridostigmine|16 weeks after initiation of pyridostigmine|Change in total CD4+ T-cell counts|||CD4+ T-cell count/uL||Standard Deviation|Mean
2801197|NCT00518115|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK/PD Analysis Population: all participants in the PK Analysis Population with sufficient dosing history for inclusion in the PK/PD analysis|||nanograms per milliliter||95% Confidence Interval|Mean
2801366|NCT00517075|Secondary|Cognitive Function||At baseline, the first and last rTMS sessions of each study phase (random and open), and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801198|NCT00518115|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population|||hour^-1||95% Confidence Interval|Mean
2801199|NCT00518115|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population|||Liters||95% Confidence Interval|Mean
2801200|NCT00518115|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed|||milliliters per hour||95% Confidence Interval|Mean
2801201|NCT00518115|Secondary|Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16|"The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, In the past week I was hungry; Q2, In the past week I thought about food; Q3, In the past week I wanted to eat; Q4, In the past week I ate more than I should have; Q5, In the past week, I craved specific food; Q6, In the past week when finished meals I felt full; Q7, In the past week when finished meals I felt satisfied."|Week 16|Safety Population. Only those participants available at the specified time point were analyzed.|||Participants|||Number
2801202|NCT00518115|Secondary|Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16|The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.|Baseline and Week 16|Safety Population: all randomly assigned participants who received at least one dose of study drug. Only those participants available at the specified time point were analyzed. Change from Baseline was calculated as the score at Week 16 minus the score at Baseline.|||Score on a scale||Standard Deviation|Mean
2801203|NCT00518115|Secondary|Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16|Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||mmol/L||Standard Deviation|Mean
2801204|NCT00518115|Secondary|Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16|Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
2801229|NCT00517933|Secondary|Change in SF36 Aggregate Physical (Adjusted Value)|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801205|NCT00518115|Secondary|Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16|Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Nanograms per liter (ng/L)||Standard Deviation|Mean
2801206|NCT00518115|Secondary|Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16|Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Nanomoles per liter (nmol/L)||Standard Deviation|Mean
2801207|NCT00518115|Secondary|Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16|Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2801208|NCT00518115|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2801209|NCT00518115|Secondary|Percent Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.|||Percent change||Standard Deviation|Mean
2801210|NCT00518115|Secondary|Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.|||Kilograms (Kg)||Standard Deviation|Mean
2801230|NCT00517933|Secondary|Short Form Health Survey (SF36) General Health|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 General Health"|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801211|NCT00518115|Secondary|Change From Baseline in Waist Circumference at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.|||Centimeters||Standard Deviation|Mean
2801212|NCT00518115|Secondary|Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2801213|NCT00518115|Secondary|Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2801214|NCT00518115|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomly assigned participants with at least one post-Baseline assessment of the primary endpoint. Participants from the exenatide arm were not included in the analysis. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2801215|NCT00518089|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
2801216|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6|Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
2801217|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6|Percentage of patients with clinical improvement of ocular signs up to Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus), with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
2801367|NCT00517075|Secondary|Smoking Behaviors||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801218|NCT00518089|Secondary|Percentage of Patients With Microbiological Cure Up to Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
2801219|NCT00518089|Secondary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
2801220|NCT00518011|Secondary|Mean Change in Body Temperature From Baseline|Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose/infusion and had at least one safety assessment performed at baseline.|||Fahrenheit||Standard Deviation|Mean
2801221|NCT00518011|Secondary|Mean Change in Blood Pressure From Baseline|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at Baseline.|||mm Hg||Standard Deviation|Mean
2801222|NCT00518011|Secondary|Mean Change in Pulse Rate From Baseline|Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at baseline.|||beats per minute||Standard Deviation|Mean
2801223|NCT00518011|Secondary|Overall Survival|Overall survival was defined as the interval between the date of randomization to the date of death from any cause.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death|||Week||95% Confidence Interval|Median
2801224|NCT00518011|Secondary|Duration of Response|Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.|Up to 2 years|PP population included all randomized participants received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. Participants available at the time of evaluation of duration of response were included in the analysis.|||Week||Standard Deviation|Mean
2801225|NCT00518011|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.|||Percentage of participants|||Number
2801226|NCT00518011|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.|||Percentage of participants|||Number
2801227|NCT00518011|Primary|Progression Free Survival|Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|Up to 2 years|Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.|||Week||95% Confidence Interval|Median
2801228|NCT00517933|Secondary|Short Form Health Survey (SF36) Aggregate Physical|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 Aggregate Physical."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801368|NCT00517075|Secondary|Theory of Mind||At baseline and the end of each study phase (random and open)|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801231|NCT00517933|Secondary|Change in Short Form Health Survey (SF36) General Health - Adjusted Value|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801232|NCT00517933|Secondary|EuroQOL (EQ-5D) Utility|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Mean raw scores of EuroQOL Utility."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801233|NCT00517933|Secondary|Change in EuroQOL (EQ-5D) Utility - Adjusted Value|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801234|NCT00517933|Secondary|EuroQOL Thermometer|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Mean raw scores of EuroQOL Thermometer."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801235|NCT00517933|Secondary|Change in EuroQOL Thermometer (Adjusted Value)|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801236|NCT00517933|Secondary|ICECAP-O|The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801237|NCT00517933|Secondary|Change in ICECAP-O Adjusted Value|"The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801238|NCT00517933|Secondary|St. George's Respiratory Questionnaire (Impacts Score)|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801239|NCT00517933|Secondary|Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801240|NCT00517933|Secondary|St. George's Respiratory Questionnaire (Activity Score)|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801241|NCT00517933|Secondary|Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801242|NCT00517933|Secondary|St. George's Respiratory Questionnaire (Symptoms Score)|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801243|NCT00517933|Secondary|Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, 12 weeks||||units on a scale||95% Confidence Interval|Mean
2801244|NCT00517933|Secondary|St. George's Respiratory Questionnaire (Total Score)|Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801245|NCT00517933|Secondary|Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values)|The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, 12 week||||units on a scale||95% Confidence Interval|Mean
2801246|NCT00517933|Secondary|Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.|Baseline, 6 week, 12 week||||units on a scale||Standard Deviation|Mean
2801247|NCT00517933|Secondary|Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, 12 week||||units on a scale||95% Confidence Interval|Mean
2801248|NCT00517933|Secondary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT|||percentage of predicted (DLCO)||Standard Deviation|Mean
2801249|NCT00517933|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values|Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, Week 12|ITT|||percentage of predicted (DLCO)||95% Confidence Interval|Least Squares Mean
2801250|NCT00517933|Secondary|Forced Vital Capacity (FVC)|Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT|||liters||Standard Deviation|Mean
2801251|NCT00517933|Secondary|Change in Forced Vital Capacity (FVC) Adjusted Values|Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, Week 12|ITT|||liters||95% Confidence Interval|Least Squares Mean
2801252|NCT00517933|Secondary|University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo."|Baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2801253|NCT00517933|Secondary|Change in Dyspnea|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better."|Measured from enrollment to 12 weeks (phase I)||||units on a scale||95% Confidence Interval|Mean
2801254|NCT00517933|Secondary|Desaturation During 6-minute Walk Test (6MWT)|The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.|Week 12|ITT population|||percentage of participants||95% Confidence Interval|Number
2801255|NCT00517933|Secondary|Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Baseline, week 12||||meters||95% Confidence Interval|Mean
2801256|NCT00517933|Secondary|6-minute Walk Distance (6MWT)|The 6MWT measures the distance that a participant can walk in a period of 6 minutes.|Baseline, 6 week, 12 week||||meters||Standard Deviation|Mean
2801257|NCT00517933|Primary|Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)|This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.|Measured at Week 12||||participants|||Number
2801258|NCT00517881|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Week 0 up to Week 24|Safety population|||participants|||Number
2801259|NCT00517881|Secondary|Percentage of Participants With Red Blood Cell Transfusion During the Study|Percentage of participant who required red blood cell transfusion during the study was reported.|Week 0 up to Week 24|ITT Population|||percentage of participants|||Number
2801260|NCT00517881|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|ITT Population. Here, 'n' signifies the number of participants evaluable for specified category.|||percentage of participants|||Number
2801261|NCT00517881|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population|||days||Standard Deviation|Mean
2801262|NCT00517881|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population; data missing at the end of the EEP was handled using the last value carried forward method.|||percentage of participants||95% Confidence Interval|Number
2801263|NCT00517881|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week 17 up to Week 24|ITT population; data missing at the end of the EEP was handled using the last value carried forward method.|||g/dL||Standard Deviation|Mean
2801264|NCT00517881|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method.|||percentage of participants||95% Confidence Interval|Number
2801265|NCT00517829|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR).|||months||95% Confidence Interval|Median
2801266|NCT00517829|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR)|||months||95% Confidence Interval|Median
2801267|NCT00517829|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Treatment will continue until disease progression or intolerable toxicity.|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2801268|NCT00517829|Secondary|Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|Treatment will continue until disease progression or intolerable toxicity|ITT population|||months||95% Confidence Interval|Median
2801269|NCT00517829|Primary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Treatment will continue until disease progression or intolerable toxicity, up to 2 years|ITT population|||months||95% Confidence Interval|Median
2801270|NCT00517751|Other Pre-specified|Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery||Overall study period||||percentage of participants|||Number
2801271|NCT00517751|Other Pre-specified|Percent of Subjects Who Reported Implant-Related Adverse Events||Overall study period||||percentage of participants|||Number
2801272|NCT00517751|Secondary|Right Leg Pain in Numerical Rating Scales (NRS)|"Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801273|NCT00517751|Secondary|Left Leg Pain in Numerical Rating Scales (NRS)|"Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801274|NCT00517751|Secondary|Back Pain in Numerical Rating Scales (NRS)|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801275|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
2801276|NCT00517751|Secondary|General Health Status -- SF-36 MCS|MCS score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801277|NCT00517751|Secondary|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801369|NCT00517075|Secondary|Depression||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801280|NCT00517751|Secondary|Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801281|NCT00517751|Secondary|Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months||||percentage of participants|||Number
2801282|NCT00517751|Secondary|Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801283|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
2801284|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
2801285|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.|||percentage of participants|||Number
2801286|NCT00517751|Secondary|Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months||||percentage of participants|||Number
2801287|NCT00517751|Secondary|Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months||||units on a scale||Standard Deviation|Mean
2801288|NCT00517751|Secondary|Treatment Success Rate at 60 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:~Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline~Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline~Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5~No additional surgery for lumbar stenosis performed~Maintenance of distraction~No dislodgement of the implant~No device-related complications"|60 months|At 60 months, 62 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.|||percentage of participants|||Number
2801289|NCT00517751|Primary|Treatment Success Rate at 24 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:~Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline~Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline~Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5~No additional surgery for lumbar stenosis performed~Maintenance of distraction~No dislodgement of the implant~No device-related complications"|24 months|At 24 months, 94 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.|||percentage of participants|||Number
2801301|NCT00517595|Secondary|Overall Response|Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.||||Participants|||Number
2801290|NCT00517699|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time interval between the entry into trial and occurrence of one of the following events: progression of disease (PD) or death as a result of primary central nervous system lymphoma (PCNSL). Participants who were withdrawn from the study without documented progression and for whom there existed case report form (CRF) evidence that evaluations had been made, were censored at the date of last tumor assessment when participant was known to be progression free. Participants without postbaseline tumor assessments but known to be alive were censored at the time of randomization. PD required a ≥25% increase in the contrast-enhanced lesion seen on MRI as compared with baseline or best response (comparison should be made to the smallest of multiple lesions); progression of ocular disease as indicated by an increase in vitreous cell count or progressive retinal or optic nerve infiltration, appearance of any new lesion or site of disease during or at the end of therapy.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
2801291|NCT00517699|Secondary|Overall Survival|Time from entry into trial until death of any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the baseline date.|Time of last follow-up assessment between Day 1 and 3 years|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
2801292|NCT00517699|Secondary|Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse||Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
2801293|NCT00517699|Primary|Percentage of Participants With a CR, CRu or Partial Response (PR)|PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
2801294|NCT00517699|Primary|Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)|CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.||||||
2801295|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14|Amount of serum IL-5 measured from blood draws|0-6 hours post allergen challenge, 1 hour after dosing, Day 14|||||||
2801296|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35|Amount of serum interleukin (IL)-5 measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35|||||||
2801297|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14|Number of peripheral blood eosinophils measured from blood draws|0-6 hours, post allergen challenge, 1 hour post treatment, Day 14|ITT Population|||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
2801298|NCT00517634|Primary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35|Number of peripheral blood eosinophils measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35|Intent-to-Treat (ITT) Population: All participants receiving at least one dose of study medication who had at least one post-randomization efficacy assessment|||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
2801299|NCT00517595|Other Pre-specified|Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.|||Months||95% Confidence Interval|Median
2801300|NCT00517595|Other Pre-specified|Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. The median progression free survival is the parameter used to describe PFS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.|||Months||95% Confidence Interval|Median
2801370|NCT00517075|Secondary|Social Functioning||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801303|NCT00517595|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.||||Months||95% Confidence Interval|Median
2801304|NCT00517595|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.||||Months||95% Confidence Interval|Median
2801305|NCT00517556|Primary|Change in Visual Analog Scale (VAS) Score|Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
2801306|NCT00517530|Other Pre-specified|Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients||at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)||||micrograms/mL||Geometric Coefficient of Variation|Geometric Mean
2801307|NCT00517530|Secondary|Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study|Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab.|Day 1 of Cycle 1|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.|||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
2801308|NCT00517530|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants|Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses.|at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants at any of the given time points). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.|||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
2801309|NCT00517530|Secondary|Percentage of Retreated Participants With Response|Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator.|by Cutoff Date: 25 November 2013 (within 4 years, 2 months)|Retreated participants|||percentage of participants|||Number
2801310|NCT00517530|Secondary|Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study|B-cell depletion was defined in two ways: definition 1 - decrease below 5% baseline level and definition 2 - decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 - return to at least 50% of baseline level and definition 2 - return to at least 0.08 x 109/L.|by the end of Phase II (within 3 years, 4 months)|Participants analyzed include those with B-cell depletion at the end of treatment (N), with assessments (n) at each time point.|||participants|||Number
2801311|NCT00517530|Secondary|Participants With Event-Free Survival (EFS) in Phase II of the Study|EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)||||participants|||Number
2801312|NCT00517530|Secondary|Duration of Response by Disease Type in Phase II of the Study|Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. Data reported for each disease cohort.|||days||Full Range|Median
2801313|NCT00517530|Secondary|Progression-free Survival (PFS) in Phase II of the Study|PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin's lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.|||days||95% Confidence Interval|Median
2801371|NCT00517075|Secondary|Global Clinical Improvement||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801314|NCT00517530|Secondary|Percentage of Participants With Partial Response (PR) in Phase II of the Study|A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)||||percentage of participants|||Number
2801315|NCT00517530|Secondary|Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study|A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)||||percentage of participants|||Number
2801316|NCT00517530|Primary|Percentage of Participants With Best Overall Response in Phase II of the Study|Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR)|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.|||percentage of participants|||Number
2801317|NCT00517530|Primary|Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study|Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab.|Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)|Safety population: All enrolled participants in Phase I, who had received at least 1 dose of obinutuzumab by 6 months.|||percentage of participants|||Number
2801318|NCT00517413|Secondary|Mean Ferritin Levels Over Time|Ferritin is a protein found inside cells that stores iron so that the body can use it later. A ferritin test indirectly measures the amount of iron in your blood. The Ferritin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for ferritin are as follows: Female: min-max for lower limit=6 - 50 mcg/L and min-max for upper limit=120 - 400 mcg/L; Male: min-max for lower limit=10 - 50 mcg/L and min-max for upper limit=200 - 400 mcg/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||mcg/L||Standard Deviation|Mean
2801319|NCT00517413|Secondary|Mean C-Reactive Protein Levels Over Time|C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The CRP test is a general test to check for inflammation in the body.The CRP levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for CRP are as follows: Female/Male: min-max for lower limit=0 - 10 mg/L and min-max for upper limit=0.5 - 30 mg/L.|Baseline (Week 0), 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||mg/L||Standard Deviation|Mean
2801320|NCT00517413|Secondary|Mean Albumin and Transferrin Levels Over Time|The albumin and transferrin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for albumin are as follows: Female/Male: min-max for lower limit=30 - 35 g/L and min-max for upper limit=48 - 55 g/L. The standard reference ranges for transferrin are as follows: Female/Male: min-max for lower limit=1.5 - 2.3 g/L and min-max for upper limit=2.87 - 4.3 g/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study.|||g/L||Standard Deviation|Mean
2801321|NCT00517413|Secondary|Mean Transferrin Saturation Levels Over Time|Transferrin saturation (TSAT) is the ratio of serum iron and total iron-binding capacity. Transferrin is a blood protein that picks up iron absorbed by the intestines and transports it from one location to another. When iron absorption is abnormally high, transferrin proteins become more saturated with iron. An elevated TS value therefore reflects an increase in iron absorption. The TSAT levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. TSAT was calculated automatically in the electronic case report form (eCRF) according to the following formulae: TSAT= (Serum Iron*100)/(Transferrin*1.41) or TSAT=(Serum Iron*100)/TIBC. Calculated data was not provided by laboratory; therefore no reference range is available.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
2801322|NCT00517413|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The creatinine, iron, and total iron binding capacity (TIBC) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for creatinine are as follows: Female: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=79.56 - 123.76 mmol/L; Male: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=97.24 - 123.76 mmol/L. The standard reference ranges for iron are as follows: Female: min-max for lower limit=6.265 - 10.74 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L and Male: min-max for lower limit=6.265 - 11.635 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L. The standard reference ranges for TIBC are as follows: Female: min-max for lower limit=19.69 - 49.046 mmol/L and min-max for upper limit=62.65 - 88.963 mmol/L and Male: min-max for lower limit=19.69 - 52.089 mmol/L and min-max for upper limit=62.65 - 80.55 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||μmol/L||Standard Deviation|Mean
2801372|NCT00517075|Primary|Clinical Improvement of Negative Symptoms (Positive and Negative Syndrome Scale [PANSS] Negative Symptoms Subscale) Relative to Pre-treatment Baseline.||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2801323|NCT00517413|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for phosphate are as follows: Female/Male: min-max for lower limit= 0.48435 - 0.9687 mmol/L and min-max for upper limit=1.45305 - 2.2603 mmol/L. The standard reference ranges for potassium are as follows: Female/Male: min-max for lower limit=3.1 - 3.7 mmol/L and min-max for upper limit=5 - 5.5 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||mmol/L||Standard Deviation|Mean
2801324|NCT00517413|Secondary|Mean White Blood Cells and Thrombocyte Levels Over Time|The white blood cells (WBC) and thrombocyte levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for WBC are as follows: Female/Male: min-max for lower limit= 3.5 - 5*10^9 cells/L and min-max of upper limit= 9 -13.5*10^9 cells/L. The standard reference ranges for thrombocyte are as follows: Female/Male: min-max for lower limit= 130 - 150*10^9 cells/L and min-max of upper limit= 300 - 450*10^9 cells/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||10^9 cells/L||Standard Deviation|Mean
2801325|NCT00517413|Secondary|Mean Hematocrit Levels Over Time|The haematocrit (HCT) levels in fraction were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for hematocrit are as follows: Female: min-max for lower limit=0.12 - 0.38 and min-max of upper limit=0.43 - 0.537; Male: min-max for lower limit=0.35 - 0.45 and min-max of upper limit=0.45 - 0.54.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2801326|NCT00517413|Secondary|Mean Haemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for Hb are as follows: Female: min-max for lower limit=11 to 13 g/dL and min-max for upper limit=14 to 18.1 g/dL; Male: min-max for lower limit=12 to 14.2 g/dL and min-max for upper limit=16 to 18.1 g/dL.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
2801327|NCT00517413|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.|Up to Week 52|The safety population included all participants who entered into the study.|||participants|||Number
2801328|NCT00517413|Secondary|Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red blood cell (RBC) transfusions were permitted during the treatment period in case of medical need. The pre-transfusion Hb level was measured before any transfusion was administered.|Baseline (Week 0) to Week 44|The safety population included all participants who entered into the study.|||participants|||Number
2801329|NCT00517413|Secondary|Mean Monthly Dose of C.E.R.A During the DTP and EEP|The initial dose of C.E.R.A. was 120, 200, or 360 mcg IV or SC every 4 weeks for 48 weeks, which was based on the last dose of the previous ESA. Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP and the EEP. The reference Hb value was taken as the mean of all Hb assessments during the stability verification period. The mean monthly doses of C.E.R.A during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||mcg||Standard Deviation|Mean
2801330|NCT00517413|Secondary|Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP (Week 0 to Week 16) and the EEP (Weeks 16 to 24). The reference Hb value was taken as the mean of all Hb assessments during the stability verification period (Weeks -4, -3, -2, -1). The percentage of participants requiring C.E.R.A dose adjustments during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||Percentage of participants|||Number
2801331|NCT00517413|Secondary|Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean C.E.R.A dose required to maintain the Hb level within the range 10.5-12.5 g/dL throughout the EEP is presented.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||mcg||Standard Deviation|Mean
2801332|NCT00517413|Secondary|Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean time (days) spent by the participants in the Hb target range 10.5 to 12.5 is reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||days||Standard Deviation|Mean
2801333|NCT00517413|Secondary|Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The percentage of participants maintaining their mean Hb concentration within the target range 10.5 and 12.5 g/dL throughout the EEP are reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||Percentage of participants||95% Confidence Interval|Number
2801334|NCT00517413|Secondary|Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean change in the Hb concentration between the Stability Verification Period (SVP) and the EEP is reported.|SVP (Week -4 to -1), EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.|||g/dL||Standard Deviation|Mean
2801335|NCT00517413|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter|The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant's all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).|EEP (Week 16 to 24)|The Per-Protocol Population (PP) included all participants in the safety population except those who had <3 recorded Hb values; withdrawn; inadequate iron defined as mean serum ferritin =<100 nanogram/milliliter (ng/mL) or mean TSAT=<20% or mean hypochromic RBCs>=10%; or had missing administration of C.E.R.A. all during EEP (Week 16-24).|||Percentage of participants||95% Confidence Interval|Number
2801336|NCT00517361|Secondary|Correlation of Response to BRCA1 Methylation Status|The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.|Up to 5 years|This study has been terminated due to poor accrual.||||||
2801337|NCT00517361|Secondary|Duration of Response||Up to 5 years|This study has been terminated due to poor accrual.||||||
2801338|NCT00517361|Secondary|Response Rate|Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Up to 5 years|This study has been terminated due to poor accrual.||||||
2801339|NCT00517361|Primary|Progression Free Survival|Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 5 years|This study has been terminated due to poor accrual.||||||
2801340|NCT00517296|Secondary|Changes in Perianal Disease Activity Index (PDAI)|Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.|Baseline and 48 Weeks||||units on a scale||Inter-Quartile Range|Mean
2801341|NCT00517296|Secondary|Changes in Disease Activity|Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.|Baseline and 48 Weeks||||units on a scale||Inter-Quartile Range|Mean
2801342|NCT00517296|Primary|Number of Participants With Durable Fistula Healing|Complete cessation of fistula drainage at 48 weeks|at week 48||||participants|||Number
2801343|NCT00517192|Secondary|Occurrence of New AIDS Progression Events or Death||through 48 weeks of treatment|||||||
2801344|NCT00517192|Secondary|Change From Baseline in log10 Viral Load up to Week 48||up to week 48|||||||
2801345|NCT00517192|Secondary|Change From Baseline in CD4+ Cell Count up to Week 48||up to week 48|||||||
2801346|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 48||up to week 48|||||||
2801347|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 24||up to week 24|||||||
2801348|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 8||up to week 8|||||||
2801349|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 48||up to week 48|||||||
2801350|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 24||up to week 24|||||||
2801351|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8||up to week 8|||||||
2801352|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat||up to 48 weeks|||||||
2801353|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF||up to 48 weeks|||||||
2801354|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored||up to 48 weeks|||||||
2801355|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat||up to 48 weeks|||||||
2801356|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF||up to 48 weeks|||||||
2801357|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored||up to 48 weeks|||||||
2801358|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat||up to 48 weeks|||||||
2801359|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF||up to 48 weeks|||||||
2801360|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored||up to 48 weeks|||||||
2801361|NCT00517192|Secondary|Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.||48 weeks of treatment|||||||
2801373|NCT00517010|Secondary|1. Change in BCVA From Baseline|change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline|24 months||||change in number of letters||Standard Deviation|Mean
2801374|NCT00517010|Primary|Incidence and Severity of Ocular Adverse Events|Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.|24 months||||number of adverse events|||Number
2801375|NCT00516919|Primary|Participant BMI|Body Mass Index (BMI)|4 months and 6 month follow-up|Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used.|||kg/m^2||Standard Deviation|Mean
2801376|NCT00516906|Secondary|Rating of Skin Condition|Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)|Daily up to 7 Days (average 3-7 days of wear)||||Units on a scale||Standard Deviation|Mean
2801377|NCT00516906|Secondary|Clinician Overall Satisfaction With Dressing|Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor|Daily up to 7 Days (average 3-7 days of wear)||||Units on a scale||Standard Deviation|Mean
2801378|NCT00516906|Primary|Clinician Overall Satisfaction With Catheter Securement|Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor|Daily up to 7 Days (average 3-7 days of wear)||||Units on a scale||Standard Deviation|Mean
2801379|NCT00516893|Secondary|Annualized Relapse Rate|Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator's clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse.|Through Week 36|Participants who received at least 1 dose of study drug.|||relapses/participant-years|||Number
2801380|NCT00516893|Secondary|Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Week 36|Participants with EDSS scores at Baseline and Week 36 (includes participants who withdrew from the study).|||scores on a scale||Standard Deviation|Mean
2801381|NCT00516893|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as 'related' or 'not related' to study drug, and categorized as 'mild' moderate' or 'severe' per protocol.|AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.|Participants who received at least 1 dose of study drug.|||participants|||Number
2801382|NCT00516893|Primary|Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status|Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.|Assessed every 12 weeks from Week 0 (Baseline) to Week 36|Participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody assessment after the first dose.|||participants|||Number
2801383|NCT00516737|Secondary|Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose|"Level of functional disability was assessed on a paper diary by the participants.~Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose."|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2801384|NCT00516737|Secondary|Number of Participants With Absence of Nausea at 2 Hours Post-dose|Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2801385|NCT00516737|Secondary|Number of Participants With Absence of Phonophobia at 2 Hours Post-dose|Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2801386|NCT00516737|Secondary|Number of Participants With Absence of Photophobia at 2 Hours Post-dose|Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2801387|NCT00516737|Secondary|Number of Participants With no Rescue Use up to 24 Hours Post-Dose|Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.|24 hours post-dose|The FAS population included all randomized and treated participants.|||Participants|||Number
2801452|NCT00516139|Secondary|Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period|Participants were considered to be seizure-free if they did not report any seizures at Baseline.|Week 30 or 33|Safety Population. Participants who were seizure-free at Baseline were analyzed.|||participants|||Number
2801388|NCT00516737|Secondary|Number of Participants With 24-Hour Sustained Pain Freedom|24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.|24 hours post-dose|The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.|||Participants|||Number
2801389|NCT00516737|Primary|Number of Participants Who Are Pain Free at 2 Hours Post-Dose|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.|2 hours post-dose|Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2801390|NCT00516503|Secondary|Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 4 weeks|All patients that were assessed for adverse events are used in this analysis.|||Participants|||Count of Participants
2801391|NCT00516503|Secondary|Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks|The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.|Up to 4 weeks||||units on a scale * week||Standard Deviation|Mean
2801392|NCT00516503|Secondary|Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4|Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported.|Up to 4 weeks||||units on a scale * week||Standard Deviation|Mean
2801393|NCT00516503|Secondary|Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)|Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.|At 4 weeks||||units on a scale||Standard Deviation|Mean
2801394|NCT00516503|Secondary|Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|Up to 4 weeks|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.|||(units on a scale)*week||Standard Deviation|Mean
2801395|NCT00516503|Secondary|Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|From Baseline to week 4|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse > event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an > adverse event, one patient died, and 18 refused for non-specified reasons.|||(units on a scale)* week||Standard Deviation|Mean
2801396|NCT00516503|Primary|Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20]|The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test.|From baseline to 4 weeks|There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons.|||(units on a scale) * week||Standard Deviation|Mean
2801397|NCT00516386|Secondary|Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days||||ng/ml||Standard Error|Mean
2801398|NCT00516386|Primary|Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days|16 subjects were screened for the study, and 10 completed the study. 10 were analyzed.|||ng/ml||Standard Error|Mean
2801399|NCT00516321|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
2801400|NCT00516321|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
2801401|NCT00516321|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||beats per minute||Standard Deviation|Mean
2801402|NCT00516321|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2801403|NCT00516321|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2801404|NCT00516321|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of abnormal alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment."|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given).|||participants|||Number
2801405|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
2801406|NCT00516321|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population|||participants|||Number
2801417|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|||Gi/L||Full Range|Median
2801407|NCT00516321|Secondary|Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase|||participants|||Number
2801408|NCT00516321|Secondary|Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study|||participants|||Number
2801409|NCT00516321|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2801410|NCT00516321|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.|||participants|||Number
2801411|NCT00516321|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.|||weeks||Standard Deviation|Mean
2801412|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2801413|NCT00516321|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2801414|NCT00516321|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 12|ITT Population|||participants|||Number
2801415|NCT00516321|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 12|ITT Population|||participants|||Number
2801416|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population|||participants|||Number
2805538|NCT00484159|Primary|Cost Per Successful Procedure|Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.|3-months||||U.S. dollars|||Number
2801418|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Gi/L||Full Range|Median
2801419|NCT00516321|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.|||participants|||Number
2801420|NCT00516321|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase|||participants|||Number
2801421|NCT00516321|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase|||participants|||Number
2801422|NCT00516295|Primary|Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab|Time from enrollment to disease progression, death, second malignant neoplasm, or last patient follow-up whichever occurs first. Patients who experience disease progression, death or second malignant neoplasm will be considered to have experienced an event; otherwise the patient will be considered censored at last follow-up.|Maximum of 5 years after enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.|||days of event free survival||95% Confidence Interval|Median
2801423|NCT00516295|Primary|The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.|Limiting toxicity defined as Any Grade IV hematological toxicities lasting longer than 7 days, myelosuppression causing delays > 14 days in delivery of therapy, > Grade 3 thromboembolic events, > Grade 3 bleeding events, > Grade 2 hypertension, > Grade 2 proteinuria.|First 2 courses (42 days) of therapy|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.|||number of toxicities|||Number
2801424|NCT00516269|Primary|Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement|"The primary endpoint is the fatigue worst score (range: 0 - 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). Worst fatigue is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in fatigue worst score between post-Methylphenidate measurement and post-Placebo measurement."|At end of two 2-week treatment cycles (4 weeks total)|It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.|||units on a scale||Standard Deviation|Mean
2801425|NCT00516217|Secondary|6 Month Progression Free Survival Rate|"Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.~Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node."|6 months||||percentage of participants||95% Confidence Interval|Number
2801426|NCT00516217|Secondary|12 Month Overall Survival Rate|Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.|12 months||||percentage of participants||95% Confidence Interval|Number
2801427|NCT00516217|Primary|Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.~CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions."|Duration of treatment (up to 10 years)||||participants|||Number
2801428|NCT00516165|Secondary|Overall Survival|The median overall survival was 8.4 months (95% CI, 3.9-21.1 months). Only 2 ((8 %) patients were progression-free at 24 weeks. The study did not proceed to the second stage of the phase 2 portion of the study.|2 years||||months||95% Confidence Interval|Median
2801429|NCT00516165|Secondary|Time to Progression|3.9 months with a CI of 21-|2 years||||month||95% Confidence Interval|Median
2801430|NCT00516165|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||percentage of patient response||95% Confidence Interval|Number
2801431|NCT00516165|Secondary|Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC|Everolimus given at 10 mg/day as a single agent was well tolerated in patients with advanced HCC.|2 years|Patients with histologically confirmed measurable advanced HCC. The primary end points were determination of a safe dosage of everolimus and progression-free survival at 24 weeks.|||Participants|||Count of Participants
2801432|NCT00516165|Primary|Progression-free Survival Rate at 24 Weeks|"Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~This information will be collected during two years of patient participation."|2 years||||months||95% Confidence Interval|Median
2801433|NCT00516165|Primary|Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).||2 years|Patients with histologically confirmed measurable advanced Hepatocellular Carcinoma.|||mg|||Number
2801434|NCT00516139|Secondary|Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. KA is defined as the rate at which a drug enters the body after administration. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||1/h||95% Confidence Interval|Mean
2801435|NCT00516139|Secondary|Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. V/F is defined as the apparent volume in which a drug is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||liters||95% Confidence Interval|Mean
2801436|NCT00516139|Secondary|Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. Clearance is defined as the volume of LTG per unit time eliminated from serum. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to Clinical Pharmacokinetics Modelling and Simulation, Clinical Pharmacology, and Discovery Medicine (CPDM) by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||Liters per hour||95% Confidence Interval|Mean
2801437|NCT00516139|Secondary|Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA|The blood samples were collected at the specified study visits; however, serum LTG concentrations were summarized by dose regimen, not by study week. The serum was assayed for LTG using an approved method under the management of Worldwide Bioanalysis, GlaxoSmithKline.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.|||Micrograms per milliliter|serum concentrations|Full Range|Median
2801438|NCT00516139|Secondary|Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of cholesterol, HDL cholesterol, LDL cholesterol, glucose, potassium, sodium, triglycerides, and urea/BUN at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||millimoles (mmol) per liter||Full Range|Median
2801439|NCT00516139|Secondary|Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of DB, TB, and creatinine at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||micromoles (µmol) per liter||Full Range|Median
2801440|NCT00516139|Secondary|Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of Alk P, Ala AT, and Asp AT at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||International units per liter||Full Range|Median
2801441|NCT00516139|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of RBC count at the indicated time points in the study from the Baseline value. Change from baseline is measured as the number of red blood cells x 10^12 per liter.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Tera (10^12) cells per liter||Full Range|Median
2801442|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCV at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Femtoliters||Full Range|Median
2801443|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCH at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||picograms||Full Range|Median
2801444|NCT00516139|Secondary|Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the values of MCHC, albumin, and total protein at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||grams per liter||Full Range|Median
2801445|NCT00516139|Secondary|Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Percent change from Baseline = (value at each indicated time point in the study minus respective Baseline value divided by Baseline value) x 100.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Percent change in counts||Full Range|Median
2801446|NCT00516139|Secondary|Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of basophil, eosinophil, hemoglobin, lymphocyte, monocyte, ANC, platelet count, and WBC count at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Giga (10^9) cells per liter||Full Range|Median
2801447|NCT00516139|Secondary|Change From Baseline in the Weight at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of weight measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||kilograms||Standard Deviation|Mean
2801448|NCT00516139|Secondary|Change From Baseline in the Height at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of height measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||centimeters||Standard Deviation|Mean
2801449|NCT00516139|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the values of systolic and diastolic blood pressures recorded by the investigator at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2801450|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale|Investigators rated the participants' overall clinical status at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants' condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Participants with missing data were not analyzed.|||participants|||Number
2801451|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale|Investigators rated the participants' seizure severity at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants' condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Only those participants who had seizures at baseline were analyzed.|||participants|||Number
2801453|NCT00516139|Secondary|Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study|Participants recorded the number of seizures, by seizure type, as well as the duration of episodes of innumerable seizure activity in their daily diaries during all phases of the study. For participants who withdrew from the study, seizure data were averaged for the portion of the study the participant completed up to the time of study drug discontinuation. Participants who experienced a change from Baseline in the weekly seizure frequency were categorized as having a >=25%, >=50%, >=75%, or 100% reduction or a >=50% increase in percent change from Baseline in weekly seizure frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.|||participants|||Number
2801454|NCT00516139|Secondary|Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study|Partial-onset sz. have a focal site of onset; sz. activity is initially limited to 1 brain hemisphere. Partial sz. can remain simple or complex, or evolve to generalized tonic-clonic sz. Participants (par.) recorded the number of sz., by type as well as the episode duration of innumerable sz. activity), in daily diaries. If par. withdrew from study, data were averaged for the study portion the par. completed up to the time of drug discontinuation. Percent change from BL = (BL value minus study phase value divided by BL value) x 100; positive values indicate reduction from BL in sz. frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.|||Percent change in seizure frequency||Full Range|Median
2801455|NCT00516139|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)|Safety Population: all participants who were enrolled and took at least one dose of study drug|||participants|||Number
2801456|NCT00516074|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change from baseline to endpoint in HbA1c|12 weeks|Intent to treat; Last observation carried forward|||percent||Standard Error|Least Squares Mean
2801457|NCT00516074|Secondary|Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2801458|NCT00516074|Secondary|Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2801459|NCT00516074|Secondary|Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||beats per minute||Standard Error|Least Squares Mean
2801460|NCT00516074|Secondary|Change in Daytime Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward|||beats per minute||Standard Error|Least Squares Mean
2801461|NCT00516074|Primary|Change in Mean 24-hour Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.|12 weeks|Intent to treat; Last observation carried forward|||beats per minute||Standard Error|Least Squares Mean
2801462|NCT00516048|Primary|Incidence of Potentially Immune-related Treatment-emergent Adverse Events|Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study|24 weeks|Intent to Treat|||participants|||Number
2801463|NCT00516048|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status|24 weeks|Intent to Treat; Last Observation Carried Forward|||percent||Standard Deviation|Mean
2801464|NCT00516048|Primary|Treatment-emergent Antibody Status (Maximum Titer Level Experienced)|Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)|24 weeks|Intent to Treat|||Participants|||Number
2801465|NCT00515879|Secondary|Range of Impaired Functioning Tool|The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment).|Measured at Months 3, 6, and 9 post-treatment|The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.|||score on a scale||Standard Deviation|Mean
2801466|NCT00515879|Secondary|Liebowitz Self-Rated Disability Scale|Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment).|Measured at Months 3, 6, and 9 post-treatment|The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.|||score on a scale||Standard Deviation|Mean
2829787|NCT00303823|Primary|Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease||4 months||||participants|||Number
2801467|NCT00515879|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire|The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100).|Measured at Months 3, 6, and 9 post-treatment|The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.|||percentage of maximum||Standard Deviation|Mean
2801468|NCT00515879|Secondary|Social Phobia and Anxiety Inventory|The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety.|Measured at Months 3, 6, and 9 post-treatment|The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.|||score on a scale||Standard Deviation|Mean
2801469|NCT00515879|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).|Measured at Months 3||||LSAS scores||95% Confidence Interval|Mean
2801470|NCT00515879|Primary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).|Measured at Months 3 (immediately after treatment)||||Units on a scale||95% Confidence Interval|Mean
2801471|NCT00515827|Secondary|Number of Participants Who Discontinued Study Drug|Participants who discontinued randomized study treatment for any reason|From first day of treatment to week 12|All 53 participants|||participants|||Number
2801472|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24|Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are 'possibly', probably', or definitely' related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.|From week 12 to week 24||||participants|||Number
2801473|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12|"Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are possibly, probably or definitely related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading."|From first day of treatment to week 12|All participants on study treatment|||participants|||Number
2801474|NCT00515827|Secondary|Change in CD8+/CD38+/HLA-DR+ Percent|Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who stayed on study treatment and had not experienced virologic failures.|||% CD8 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
2801475|NCT00515827|Secondary|Change in CD4+/CD38+/HLA-DR+ Percent|Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure|||% CD4 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
2801476|NCT00515827|Secondary|Change in Total CD8 Cell Count|CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure|||cells/mm^3||Inter-Quartile Range|Median
2801477|NCT00515827|Secondary|Change in Total CD4 Cell Count|CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure|||cells/mm^3||Inter-Quartile Range|Median
2801478|NCT00515827|Secondary|Change in HIV-1 RNA Level|Change in HIV-1 RNA level, as measured by single copy assay (units are copies/ml), from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2.|At pre-entry, entry, weeks 10 and 12|All participants who were on study treatment and had not experienced virologic failure|||copies/mL||Inter-Quartile Range|Median
2801479|NCT00515827|Primary|HIV-1 RNA Level|HIV-1 RNA level, as measured by single copy assay (units are copies/ml), averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value.|At Weeks 10 and 12|49 subjects who were on study treatment before week 10 and did not experience virologic failure by week 12|||copies/mL||Inter-Quartile Range|Median
2801480|NCT00515723|Primary|Clamp Derived Insulin Sensitivity (mg/kg/Min)|This study hypothesized that antipsychotic treatment would decrease insulin sensitivity, with larger adverse effects for olanzapine. Insulin sensitivity describes how sensitive the body is to the effects of insulin.|The relevant time points include baseline and week 12.|Modified Intent to Treat (ITT) sample with Week 0 and Week 12 data. Two Quetiapine participants were excluded from analyses due to failure to adhere to the protocol.|||mg/kg/min||Standard Error|Mean
2801481|NCT00515723|Primary|DEXA Total Fat|This study hypothesized that antipsychotic treatment would increase total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.|The relevant time points include baseline, week 6 and week 12.|Modified Intent to Treat (ITT) sample with week 0, week 6 and week 12 data. Two Quetiapine participants were excluded from analyses due to failure to adhere to the protocol.|||kilograms of body fat||Standard Error|Mean
2801482|NCT00515697|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to study completion (up to 34 months) plus 30-day safety follow-up|Intent-to-treat population: participants who received any quantity of ramucirumab.|||participants|||Number
2801483|NCT00515697|Secondary|Maximum Concentration (Cmax) of Ramucirumab||1 hour after the end of the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2801484|NCT00515697|Secondary|Minimum Concentration (Cmin) of Ramucirumab||Immediately prior to the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2801485|NCT00515697|Secondary|Median Duration of Overall Response|Duration of response is the interval from the date of initial documented response [confirmed complete response (CR) or partial response (PR)] to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data from participants who did not relapse were censored on the day of their last tumor assessment.|Time of first response (CR or PR) to disease progression, initiation of other (or additional) antitumor therapy, or death due to any cause (up to 34 months)|Participants who received any quantity of ramucirumab and had confirmed complete response or partial response. The number of participants censored was 1.|||months||95% Confidence Interval|Median
2801486|NCT00515697|Secondary|Percentage of Participants With Objective Response (Objective Response Rate) at 12 Weeks|The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at Week 12, as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved at 12 weeks was CR or PR/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
2801487|NCT00515697|Secondary|Percentage of Participants Showing Disease Control at Week 12|Participants who were alive and did not experience disease progression were considered to have disease control at 12 weeks. Disease control was based on lack of disease progression using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. According to RECIST criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or detection of new lesion. Participants whose disease progression was symptomatic were not considered to have disease control. The percentage of participants showing disease control=(number of participants who did not have disease or symptomatic progression at Week 12/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
2801488|NCT00515697|Secondary|Progression-Free Survival|Progression-free survival (PFS) is measured from the date of the first dose to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria or death from any cause. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data for participants whose disease does not progress or for whom no post-baseline assessment is made are censored at the day of their last tumor assessment. Data for participants whose disease does not progress who are subsequently lost to follow-up are also censored at the day of their last tumor assessment.|First dose to measured progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab. The number of participants censored was 4.|||months||95% Confidence Interval|Median
2801500|NCT00515541|Primary|Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)|The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks|||percent||Inter-Quartile Range|Median
2801489|NCT00515697|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|The percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response during therapy is CR or PR/number of participants treated)*100.|First dose to date of objective progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab.|||percentage of participants||95% Confidence Interval|Number
2801490|NCT00515671|Secondary|Psychiatric Symptoms (PANSS Total)|Psychiatric symptomatology was assessed by the Positive and Negative Syndrome Scale (PANSS), a widely-used, 30-item rating scale. The PANSS has previously demonstrated satisfactory internal consistency, test-retest reliability, and validity. Raters were trained to reach inter-rater agreement of .80 prior to interviewing participants. This is the total score, which ranges from 30 to 210, with higher scores indicating more severe symptoms.|Baseline, 9 months, 18 months||||units on a scale||Standard Deviation|Mean
2801491|NCT00515671|Primary|Illness Management Ratings|Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.|Baseline, 9 months, 18 months||||units on a scale||Standard Deviation|Mean
2801492|NCT00515619|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.|||Percentage of subjects|||Number
2801493|NCT00515619|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.~Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.|||Percentage change||Full Range|Median
2801494|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||Subjects|||Number
2801495|NCT00515619|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||Subjects|||Number
2801496|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.|||Subjects|||Number
2801497|NCT00515541|Primary|EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid|Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks. Change in EQELS value after the addition of Arachidonic Acid.|||mobility units||Inter-Quartile Range|Median
2801498|NCT00515541|Primary|Bleeding Time|Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks|||seconds||Inter-Quartile Range|Median
2801499|NCT00515541|Secondary|The Occurence of Any Type of Bleeding|was there any bleeding occurance during the accessed interval|up to and including closeout at 24 weeks|Subjects would indicate if they had any bleeding episode during the trial at each of their testing intervals|||Number of occurance|||Number
2830874|NCT00294671|Secondary|Modified Body Mass Index (mBMI);|The product of body mass index (BMI) and serum albumin level (g/L) [kg/M2xg/L].|Baseline, 1 and 2 years||||kg/M2xg/L||95% Confidence Interval|Mean
2801501|NCT00515502|Secondary|Mean Serial Specific Airway Resistance (sGaw) Over 24 Hours After Dosing on Day 1 of Each Treatment Period|sGaw is the specific airways resistance (mid) which was assessed by whole body plethysmography. Values used were the mean of the 3 readings recorded at each timepoint. sGaw measurements were taken at 2 hour (h), 6 h, 12 h and 24 h post-dose of each treatment period. 1/kPa.s=1(the inverses)/kPa (kilopascal).s (second)|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||1/kPa*s||Standard Error|Geometric Mean
2801502|NCT00515502|Secondary|Mean Serial FEV1over 24 Hours After Dosing on Day 1 of Each Treatment Period|Serial spirometry assessments were conducted on Day 1 of each treatment period over the course of 24 hours and were taken at 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose. The maximum of the 3 FEV1 measurements for each participant, treatment period and timepoint were used in the calculation of the mean for each treatment group at each timepoint.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Error|Least Squares Mean
2801503|NCT00515502|Secondary|Fraction of Dose Excreted Unchanged in Urine From Time Zero to: 24 Hours [Fe(0-24)] and 48 Hours [Fe(0-48)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Fe(0-24) and Fe(0-48). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0-2 h, 2-8 h, 8-12 h, 12-24 h and 24-48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||Percentage of total dose administered||Full Range|Median
2801504|NCT00515502|Secondary|Half-life for Renal Excretion of UMEC on Day 1|The terminal half-life (t1/2) of UMEC is defined as the time required for the urine concentration of UMEC to reach half of its original concentration. Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0-2 h, 2-8 h, 8-12 h, 12-24 h and 24-48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2801505|NCT00515502|Secondary|Renal Clearance (CLr) of UMEC Following Dose Administration on Day 1|The CLr is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2801506|NCT00515502|Secondary|Amount of Drug Excreted Unchanged in Urine From Time Zero to: 2h [Ae(0-2)] , 8h [Ae(0-8)], 12h [Ae(0-12)], 24h [Ae(0-24)], and 48h [Ae(0-48)]; and Area Under the Excretion Rate Curve From Time Zero to: 18h [AUER(0-18)] and 36h [AUER(0-36)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Ae(0-2), Ae(0-8), Ae(0-12), Ae(0-24), Ae(0-48), AUER(0-18) and AUER(0-36). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0-2 h, 2-8 h, 8-12 h, 12-24 h and 24-48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||ng||Geometric Coefficient of Variation|Geometric Mean
2801507|NCT00515502|Secondary|Time of Maximum Observed Plasma Concentration (Tmax), Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast), and Plasma Half-life (t1/2) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive tmax, tlast and t1/2. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population. Only those participants with non-missing observations (including non-calculable values) were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the PK Population|||Hours||Full Range|Median
2801508|NCT00515502|Secondary|Maximum Observed Plasma Concentration (Cmax) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the Cmax. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2801509|NCT00515502|Secondary|Area Under Concentration-time Curve From Time 0 to 2 Hours [AUC(0-2)] and Area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-t)] of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the AUC(0-2) and AUC(0-t). Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|Pharmacokinetic (PK) Population:all participants in the All Subjects Population for whom a PK sample was obtained and analyzed.|||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2801540|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2801541|NCT00515463|Secondary|Basophils Change From Baseline at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2801542|NCT00515463|Secondary|Basophils Change From Baseline at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2801510|NCT00515502|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC measurements were taken at pre-dose and 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
2801511|NCT00515502|Primary|Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the calcium, bicarbonate, chloride, glucose, IP, potassium, sodium, and urea at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2801512|NCT00515502|Primary|Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2801513|NCT00515502|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, and GGT at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2801514|NCT00515502|Primary|Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of platelets count and WBC count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2801515|NCT00515502|Primary|Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the red blood cells count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2801516|NCT00515502|Primary|Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle volume at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Femtoliters (FL)||Standard Deviation|Mean
2801517|NCT00515502|Primary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle hemoglobin at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||picograms/cell (pg)||Standard Deviation|Mean
2801518|NCT00515502|Primary|Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2801519|NCT00515502|Primary|Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Grams per liter (G/L)||Standard Deviation|Mean
2801520|NCT00515502|Primary|Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population|||Percentage||Standard Deviation|Mean
2801521|NCT00515502|Primary|Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four-hour Holter monitoring was conducted to measure heart rate for the 24-h period following dosing of each treatment period and the mean value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2801522|NCT00515502|Primary|Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four hour Holter monitoring was conducted to measure heart rate for the 24-hour period following dosing at each treatment period and the maximum value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2801523|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcF at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
2801524|NCT00515502|Primary|Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QT interval corrected according to Fredericia's formula (QTcF) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
2801525|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcB at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
2801526|NCT00515502|Primary|Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs (electrocardiograms) were performed to measure QT interval corrected according to Bazzet's formula (QTcB) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Milliseconds (msec)||Standard Error|Least Squares Mean
2801527|NCT00515502|Primary|Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2801528|NCT00515502|Primary|Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2801543|NCT00515463|Secondary|Basophils Change From Baseline at Month 1|Laboratory hematology basophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2801544|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2801545|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2801529|NCT00515502|Primary|Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2801530|NCT00515502|Primary|Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2801531|NCT00515502|Primary|Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for heart rate (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2801532|NCT00515502|Primary|Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45min, 1.5 hour (h) 4 h, 8 h, and 24 h post-dose of each treatment period and the maximum value for heart rate (0-4hours) was derived at rest. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2801533|NCT00515502|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)|All Subjects Population: all participants who received at least one dose of study medication.|||Participants|||Number
2801534|NCT00515463|Secondary|Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3|Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Day 1 to Month 12|Patients who received ≥ 1 dose of investigational product.|||Participants|||Number
2801535|NCT00515463|Secondary|Monocytes Change From Baseline at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2801536|NCT00515463|Secondary|Monocytes Change From Baseline at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2801537|NCT00515463|Secondary|Monocytes Change From Baseline at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2801538|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2801539|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2801553|NCT00515463|Secondary|Platelets Change From Baseline at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2801554|NCT00515463|Secondary|Platelets Change From Baseline at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2801555|NCT00515463|Secondary|Platelets Change From Baseline at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2801556|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 12|Laboratory hematology reticulocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^9/L||Standard Deviation|Mean
2801557|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 6|Laboratory hematology reticulocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^9/L||Standard Deviation|Mean
2801558|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 1|Laboratory hematology reticulocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^9/L||Standard Deviation|Mean
2801559|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||g/L||Standard Deviation|Mean
2801560|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||g/L||Standard Deviation|Mean
2801561|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||g/L||Standard Deviation|Mean
2801562|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||10^12/L||Standard Deviation|Mean
2801563|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||10^12/L||Standard Deviation|Mean
2801564|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||10^12/L||Standard Deviation|Mean
2801565|NCT00515463|Secondary|Glucose Change From Baseline at Month 12|Laboratory chemistry glucose|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801566|NCT00515463|Secondary|Glucose Change From Baseline at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801567|NCT00515463|Secondary|Glucose Change From Baseline at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801568|NCT00515463|Secondary|Total Protein Change From Baseline at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||g/L||Standard Deviation|Mean
2801569|NCT00515463|Secondary|Total Protein Change From Baseline at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||g/L||Standard Deviation|Mean
2801570|NCT00515463|Secondary|Total Protein Change From Baseline at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||g/L||Standard Deviation|Mean
2801571|NCT00515463|Secondary|Albumin Change From Baseline at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||g/L||Standard Deviation|Mean
2801572|NCT00515463|Secondary|Albumin Change From Baseline at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||g/L||Standard Deviation|Mean
2801573|NCT00515463|Secondary|Albumin Change From Baseline at Month 1|Laboratory chemistry albumin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||g/L||Standard Deviation|Mean
2801574|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||umol/L||Standard Deviation|Mean
2801575|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||umol/L||Standard Deviation|Mean
2801576|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 1|Laboratory chemistry total bilirubin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||umol/L||Standard Deviation|Mean
2801577|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||U/L||Standard Deviation|Mean
2801578|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||U/L||Standard Deviation|Mean
2801579|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||U/L||Standard Deviation|Mean
2801580|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||U/L||Standard Deviation|Mean
2801581|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 6|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||U/L||Standard Deviation|Mean
2801582|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||U/L||Standard Deviation|Mean
2801583|NCT00515463|Secondary|Creatinine Change From Baseline at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||umol/L||Standard Deviation|Mean
2801584|NCT00515463|Secondary|Creatinine Change From Baseline at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||umol/L||Standard Deviation|Mean
2801585|NCT00515463|Secondary|Creatinine Change From Baseline at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||umol/L||Standard Deviation|Mean
2801586|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 12|Laboratory chemistry blood urea nitrogen|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801587|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801588|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801589|NCT00515463|Secondary|Magnesium Change From Baseline at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801590|NCT00515463|Secondary|Magnesium Change From Baseline at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801591|NCT00515463|Secondary|Magnesium Change From Baseline at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801592|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 12|Laboratory chemistry bicarbonate|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801593|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801594|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 1|Laboratory chemistry bicarbonate|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801595|NCT00515463|Secondary|Chloride Change From Baseline at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801596|NCT00515463|Secondary|Chloride Change From Baseline at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801597|NCT00515463|Secondary|Chloride Change From Baseline at Month 1|Laboratory chemistry chloride|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801598|NCT00515463|Secondary|Potassium Change From Baseline at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801599|NCT00515463|Secondary|Potassium Change From Baseline at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801600|NCT00515463|Secondary|Potassium Change From Baseline at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801601|NCT00515463|Secondary|Sodium Change From Baseline at Month 12|Sodium Change From Baseline at Month 12|Baseline, Month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.|||mmol/L||Standard Deviation|Mean
2801602|NCT00515463|Secondary|Sodium Change From Baseline at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.|||mmol/L||Standard Deviation|Mean
2801603|NCT00515463|Secondary|Sodium Change From Baseline at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.|||mmol/L||Standard Deviation|Mean
2801604|NCT00515463|Secondary|Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12|Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.|Month 12|Patients testing positive for binding antibodies to denosumab.||||||
2801605|NCT00515463|Secondary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|12 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 12 months.|||Participants|||Number
2801606|NCT00515463|Primary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|6 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 6 months.|||Participants|||Number
2801607|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection|"saliva collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 12 weeks post-injection||||grams/minute||Standard Deviation|Mean
2801608|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection|"saliva is collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 4 weeks post-injection||||grams/minute||Standard Deviation|Mean
2801609|NCT00515437|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection|9 point scale (0=no drooling, 9=severe drooling)|baseline vs 12 weeks post injection||||points on a scale||Standard Deviation|Mean
2801610|NCT00515437|Primary|Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection|9 point scale, 0 = no drooling, 9 = severe drooling|baseline versus 4 weeks post-injection|Intent to Treat (ITT)|||points on a scale||Standard Deviation|Mean
2801611|NCT00515411|Secondary|Overall Survival|Overall survival measured in months|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months||||months||95% Confidence Interval|Median
2801612|NCT00515411|Primary|6 Month Progression Free Survival (PFS)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate"|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||percentage of paticipants||95% Confidence Interval|Mean
2801613|NCT00515294|Secondary|Psycho-motor Vigilance Test (PVT)|Participants completed 10 test trials to assess their psycho-motor response using a hand held box that randomly starts a scroll of numbers in milliseconds and as soon as it starts to scroll the participant needs to press a button to stop the scrolling. The mean and standard deviations for the 10 tests were calculated as a single outcome score for each study arm. Response times were measured in milliseconds. The lower the number of milliseconds the faster the response to the random stimuli.|30 minutes post dosing||||milliseconds||Standard Deviation|Mean
2801614|NCT00515294|Primary|Lane Position Deviation|The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traffic closer to the road edge|30 minutes post dosing|Driver simulator did not work properly for 6 participants. Their data are not included.|||feet||Standard Deviation|Mean
2801615|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801616|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801617|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801618|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801619|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801620|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801621|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had stable disease.|4 years|11 out of 25 participants had a partial response.|||participants|||Number
2801622|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801623|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801624|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801625|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had a partial response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801626|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801627|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801628|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.|||participants|||Number
2801629|NCT00515216|Secondary|Tumor Specific Changes That May Alter Treatment Outcomes||4 years|This was not completed as the archived tumor samples were not of sufficient quality for DNA extraction or analysis.||||||
2801630|NCT00515216|Secondary|Disease Control Rate (DCR)|"DCR - complete response, partial response, and stable disease~Complete response - disappearance of all target and non-target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Stable disease - neither sufficient shrinkage to qualify for partial response not sufficient increase to qualify for progressive disease"|2 years||||percentage of participants||95% Confidence Interval|Number
2801631|NCT00515216|Secondary|Progression-free Survival (PFS)|Progressive disease - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|4 years||||months||95% Confidence Interval|Median
2801632|NCT00515216|Secondary|Overall Survival||4 years||||months||95% Confidence Interval|Median
2801633|NCT00515216|Primary|Overall Response Rate (ORR)|"ORR = complete response + partial response~Complete response - disappearance of all target and non-target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"|2 years||||percentage of participants||95% Confidence Interval|Number
2801634|NCT00515203|Primary|Adverse Events|Occurrence of one or more adverse events in the participant during the 12-week treatment period|12 weeks|Safety Analysis Set, composed of all participants who received at least one dose of study medication|||Participants|||Number
2801635|NCT00515203|Secondary|Requirement for Rescue Therapy (as Defined Per Protocol)|Participant required rescue therapy (as defined per protocol) during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Participants|||Number
2801636|NCT00515203|Secondary|Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks|Participant incidence of achieving an increase in platelet count ≥20 x 10^9/L above baseline for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Participants|||Number
2801637|NCT00515203|Secondary|Platelet Count ≥ 50 x 10^9/L for Two Consecutive Weeks|Participant incidence of achieving a platelet count ≥50 x 10^9/L for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Participants|||Number
2801638|NCT00515203|Secondary|Bleeding Events (Grade 2 or Higher)|Total number of bleeding events (Grade 2 or higher, i.e., mild to life-threatening, as defined in the protocol) for each participant during Weeks 2-13 (end-of-study visit for non-responders)|12-week treatment period (Weeks 2 - 13)|Efficacy Analysis Set, composed of all randomized participants|||Events per participant||Standard Deviation|Mean
2801639|NCT00515203|Secondary|Weeks With Platelet Count ≥ 50 x 10^9/L|The number of weeks with platelet count ≥ 50 x 10^9/L during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants|||Weeks||Standard Deviation|Mean
2801640|NCT00515177|Secondary|Medical Outcome Study Short Form (SF-12)|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
2801641|NCT00515177|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
2801642|NCT00515177|Secondary|State-Trait Anxiety Inventory (STAI)|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
2801643|NCT00515177|Primary|Actigraphy|Total Sleep Time from Actigraphy|8 weeks|In the PCT arm, one person who refused to take the drug and one who did not complete actigraphy were excluded. 10-2=8 In the MBSR arm, one person who did not attend MBSR, one person who attended fewer than 5 classes, and two who did not complete actigraphy were excluded. 20-4=16.|||hours||Standard Deviation|Mean
2801644|NCT00515177|Primary|Insomnia Severity Index|The Insomnia Severity Index is a 7-item scale that provides a total score indicating current (e.g., last 2 weeks) severity of insomnia symptoms with scores that can range from 0 to 28. Scores of 15 or higher indicate clinical insomnia.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
2801645|NCT00515177|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.|||units on a scale||Standard Deviation|Mean
2801646|NCT00515112|Secondary|To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.|The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.|every 8 weeks|||||||
2801647|NCT00515112|Primary|Progression Free Survival|Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.|Up to 5 years|This study has been terminated due to poor accrual.||||||
2801648|NCT00515099|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c of <\=5.6% is considered normal. HbA1c of 6.5% or higher is typical for individuals with Type 1 Diabetes mellitus (T1DM).|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat|||Percentage (%)||Standard Deviation|Mean
2801649|NCT00515099|Secondary|2-Hour and 4-Hour C-peptide Area Under the Curve (AUC) Results in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) and 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the CDER at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment), Month 24|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
2801650|NCT00515099|Secondary|Number of Participants With Major Hypoglycemic Event(s) Post Treatment Randomization/Initiation|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline (Pre-treatment), Months 12 , and 24|Intent-to-treat|||participants|||Number
2801651|NCT00515099|Secondary|Number of Participants Who Are Exogenous-Insulin-Free|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 , 18, and 24|Intent-to-treat|||participants|||Number
2801652|NCT00515099|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat|||units/day/kg||Standard Deviation|Mean
2801653|NCT00515099|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
2801654|NCT00515099|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
2801655|NCT00515086|Secondary|Surgery Group: Number of Participants With Adverse Events|The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section.|First day of treatment to study discontinuation (Up to 28 weeks)|Surgery Group participants from the Safety population who received at least one dose of study medication.|||Participants|||Number
2806999|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
2801656|NCT00515086|Secondary|No Surgery Group: Progression Free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with ≥2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.|||Weeks||95% Confidence Interval|Median
2801657|NCT00515086|Secondary|Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR)|"The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status.~Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size."|After surgery, week 4, week 8 and every 8 weeks thereafter|Study was terminated due to slow enrollment.|||Levels||Standard Deviation|Mean
2801658|NCT00515086|Secondary|Surgery Group: Progression-free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method.|After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks)|Results for the Surgery Group only include patients with residual tumor following salvage surgery.|||Weeks||95% Confidence Interval|Median
2801659|NCT00515086|Secondary|Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001)||Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.)|Study was terminated due to slow enrollment.|||Levels||Standard Deviation|Mean
2801660|NCT00515086|Primary|No Surgery Group: Best Overall Tumor Response|The best overall tumor response is reported for participants with 1 previous relapse and participants with ≥2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.|||Participants|||Number
2801661|NCT00515086|Primary|Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels|In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments.|Baseline and Day 7-9 (during salvage surgery)|Study was terminated due to slow enrollment.|||Percentage change in S6 kinase|||Number
2801662|NCT00515073|Primary|Overall Survival at 2 Years and 5 Years|The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.|Assessment at 2 years and 5 years|Two participants were inevaluable.|||percentage of participants|||Number
2801663|NCT00515034|Secondary|Patients With cIAI Who Were Clinically Cured|clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.|7 to 14 days after the end of IV therapy|participants who were clinically evaluable|||participants|||Number
2801664|NCT00515034|Secondary|Patients With VAP Who Were Clinically Cured|clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.|7 to 14 days after the end of IV therapy|the population is the number of participants who are clinically evaluable|||participants|||Number
2801665|NCT00515034|Primary|Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).|Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.|from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy|population is the as-treated analysis set - that is subjects who were administered therapy|||participants|||Number
2801666|NCT00515021|Primary|Plasminogen Activator Inhibitor-1 (PAI-1) Levels|PAI-1 levels after Eplerenone 50mg daily for 2 weeks then 100mg daily for 4 weeks. Time of administration varied in the arms, either morning or night time dosing.|after 6 weeks on Eplerenone||||ng/ml||Standard Error|Mean
2801667|NCT00515021|Primary|Plasminogen Activator Inhibitor-1 (PAI-1) Levels|baseline PAI-1 levels prior to drug administration|Baseline||||ng/ml||Standard Deviation|Mean
2801668|NCT00515008|Secondary|Mean Change From Baseline CPSS Score|The Chronic Pain Self-Efficacy Scale (CPSS) is a self-report score measuring self-efficacy with respect to chronic pain (range, 1 to 10, with higher scores indicating greater self-efficacy).|12 weeks||||units on a scale||95% Confidence Interval|Mean
2801669|NCT00515008|Secondary|Mean Change From Baseline CES-D Score|The Center for Epidemiologic Studies (CES-D) Depression Scale (range, 0 to 60, with higher scores indicating more severe depression), is a self-report measure of depressive symptoms.|12 weeks||||units on a scale||95% Confidence Interval|Mean
2801670|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Mental Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks||||units on a scale||95% Confidence Interval|Mean
2801671|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Physical Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks||||units on a scale||95% Confidence Interval|Mean
2801673|NCT00515008|Secondary|Mean Change From Baseline PSQI Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality)|12 weeks||||units on a scale||95% Confidence Interval|Mean
2801674|NCT00515008|Secondary|Mean Change From Baseline of Patient's Global Assessment Score|Patients' global assessment score was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|12 weeks||||units on a scale||95% Confidence Interval|Mean
2801675|NCT00515008|Secondary|Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity|Physicians' global assessment score was assessed separately by the study physician, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|Wks 12||||units on a scale||95% Confidence Interval|Mean
2801676|NCT00515008|Primary|Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score|Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.|wks 12||||units on a scale||95% Confidence Interval|Mean
2801677|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Pharmacokinetic Set (PK)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2801678|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)|"Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.~Note: At day 29, values for afatinib 40 mg no values reported in stage 2."|Day 29|Pharmacokinetic Set (PK)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2801679|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)|"Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.~Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2."|Day 15|Pharmacokinetic Set (PK): The PK analysis was based on all patients who were treated with afatinib and who had evaluable plasma concentration data, which consisted of data for 60 patients in Stage 1 and 35 patients in Stage 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2801680|NCT00514943|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.|||percentage of participants|||Number
2801681|NCT00514943|Secondary|Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function|"Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function~Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial."|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.|||number of participants|||Number
2801682|NCT00514943|Secondary|Time to Deterioration in HRQoL - Stage 1|"Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H&N35).~Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:~global health status (Questions 29 and 30 in EORTC QLQ C30)~pain (Questions 9 and 19 in EORTC QLQ C30)~swallowing (Questions 35 to 38 in EORTC QLQ-H&N35)"|From randomisation to deterioration in HRQoL scores before crossover.|Randomised Set (RS)|||months||95% Confidence Interval|Median
2801683|NCT00514943|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to data cut-off date.|Randomised set (RS).|||Weeks||95% Confidence Interval|Median
2801684|NCT00514943|Secondary|Progression Free Survival (PFS) After Crossover Based on Investigator Assessment|"PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.|Patients treated in stage 2|||weeks||95% Confidence Interval|Median
2801685|NCT00514943|Secondary|Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment|"PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.|Randomised set (RS).|||weeks||95% Confidence Interval|Median
2801686|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2|Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2|||Weeks||Standard Deviation|Mean
2802488|NCT00509093|Secondary|Toxicity as Measured by NCI CTC v. 3.0|"Number of patients (%) experiencing an adverse event~See adverse events section for details"|13 months from start of treatment|Number of patients (%) experiencing the adverse event|||Participants|||Count of Participants
2801687|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2|Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2|||Weeks||Standard Deviation|Mean
2801688|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)|||Weeks||Standard Deviation|Mean
2801689|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)|||Weeks||Standard Deviation|Mean
2801690|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2|||Number of participants|||Number
2801691|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
2801692|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
2801693|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2|||Number of participants|||Number
2801694|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2|||Number of participants|||Number
2801695|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
2801696|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).|||Number of participants|||Number
2801697|NCT00514943|Secondary|Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments|Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover.|From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.|Patients treated in stage 2 : This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.|||millimeters||Standard Deviation|Mean
2801698|NCT00514943|Primary|Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment|"Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates."|From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not. However, patients without baseline or post-baseline tumor measurements were excluded.|||millimeter||Standard Error|Mean
2801699|NCT00514917|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported.|From first administration of study treatment until 30 days after the last administration of study treatment|Safety population included all randomized participants who received at least part of one dose of any of the study drugs.|||participants|||Number
2801700|NCT00514917|Secondary|Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT|EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity.|Baseline, EOT (up to Month 18)|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively."|||units on a scale||Standard Deviation|Mean
2801701|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following completion of treatment of leuprolide with at least 1 follow-up PSA assessment.|||percent chance of being progression-free||95% Confidence Interval|Number
2801702|NCT00514917|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT|MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue).|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
2801703|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population|PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following the completion of treatment of leuprolide with at least 1 follow-up PSA assessment.|||months||95% Confidence Interval|Median
2801704|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT|Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
2801705|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)|FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
2801706|NCT00514917|Secondary|Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)|The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer.|Randomization until death due to prostate cancer, assessed up to Month 60|ITT population.|||participants|||Number
2801707|NCT00514917|Secondary|Overall Survival (OS): Number of Participants Who Died (All Cause)|The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause.|Randomization until death due to any cause, assessed up to Month 60|ITT population.|||participants|||Number
2801708|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in ITT Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|ITT population.|||percent chance of being progression-free||95% Confidence Interval|Number
2801709|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population|PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter [ng/mL]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|ITT population included all participants who were randomized, with study drug assignment designated according to randomization, regardless of whether participants received any study drug or a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2801710|NCT00514904|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From Day 0 up to 6 months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2801711|NCT00514904|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to one month (Day 0-Day 30) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2801712|NCT00514904|Secondary|Number of Subjects Reporting Specific Adverse Events (AEs)|Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.|From Day 0 up to 6 months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2801713|NCT00514904|Secondary|Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
2801714|NCT00514904|Secondary|Number of Subjects < 6 Years of Age With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
2801715|NCT00514904|Secondary|Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
2801716|NCT00514904|Secondary|Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.|||Participants|||Count of Participants
2801717|NCT00514904|Secondary|Anti-polysaccharide (Anti-PS) Antibody Concentrations|Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2801718|NCT00514904|Secondary|Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.|Pre vaccination (Month 0) and post vaccination, (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2801719|NCT00514904|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs)|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2802697|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 96|The change from baseline in HBV DNA at Week 96 was analyzed.|Baseline to Week 96|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
2801720|NCT00514904|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2801721|NCT00514904|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs).|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2801722|NCT00514904|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.|Pre vaccination (Month 0) and post vaccination (Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2801723|NCT00514904|Primary|Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)|Grade 3 symptom was defined as symptom that prevented normal, everyday activities.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2801724|NCT00514904|Primary|Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135|Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).|One month after vaccination (Post-vaccination, study Month 1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2801725|NCT00514852|Secondary|Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score|Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)|Change from baseline at Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
2801726|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein|Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)|Change from baseline at Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
2801727|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein|Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)|Change from baseline at Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
2801728|NCT00514852|Post-Hoc|Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30|Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)|Day 30|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
2801729|NCT00514852|Post-Hoc|Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30|Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Day 30|Intent to Treat Population (Modified)|||Units on a scale||Standard Deviation|Mean
2801730|NCT00514852|Secondary|Patient Acceptability Score (Vision) at Day 30|Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).|Day 30|Intent to treat population|||Units on a scale||Standard Deviation|Mean
2801731|NCT00514852|Secondary|Patient Acceptability Score (Dryness) at Day 30|Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).|Day 30|Intent to Treat Population|||Units on scale||Standard Deviation|Mean
2801732|NCT00514852|Secondary|Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein|Measures the stability of tear film. The average of 3 measures.|Change from baseline at Day 30|Intent to Treat Population|||seconds||Standard Deviation|Mean
2801733|NCT00514852|Secondary|Change From Baseline at Day 30 in Schirmer Test, With Anesthesia|Schirmer Test measures the rate of the secretion of tears|Change from baseline at Day 30|Intent to Treat Population|||mm/5min||Standard Deviation|Mean
2801734|NCT00514852|Primary|Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score|Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Change from baseline at Day 30|Intent to Treat Population (Modified)|||Units on a scale||Standard Deviation|Mean
2801735|NCT00514813|Secondary|Change From Baseline in Hematocrits at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||||||
2801736|NCT00514813|Secondary|Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||||||
2801737|NCT00514813|Primary|Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)||Over the course of 2 Years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||||||
2801738|NCT00514735|Secondary|Improved Quality of Life Over 6 Months Compared to Baseline.|The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||Scores on a scale||Standard Deviation|Mean
2801739|NCT00514735|Secondary|Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.|The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||AF Symptom Severity Score||Standard Deviation|Mean
2801740|NCT00514735|Secondary|Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.|Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||percent||Standard Deviation|Mean
2801741|NCT00514735|Secondary|Improvement of Left Atrial Size at 6 Months Compared to Baseline.|Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||centimeters||Standard Deviation|Mean
2801742|NCT00514735|Secondary|Acute Efficacy|"A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:~Medtronic ablation catheters were used to achieve procedure success.~All accessible pulmonary veins were isolated.~At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.~Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion)."|Procedure conclusion|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||percentage of participants||95% Confidence Interval|Mean
2801743|NCT00514735|Primary|Chronic Safety|The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||participants|||Number
2801744|NCT00514735|Primary|Acute Safety|The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.|7 days|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.|||percentage of participants||95% Confidence Interval|Mean
2801745|NCT00514735|Primary|Chronic Effectiveness|"The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:~A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes.~The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)~The Investigator judged all procedures to be acutely successful (Ablation Management arm only)."|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.|||percentage of participants with success|||Number
2801746|NCT00514709|Secondary|Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.~Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.|||Participants|||Number
2801747|NCT00514709|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2801748|NCT00514709|Primary|Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.~Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response."|Day 0 (pre-vaccination) and Day 28 post-booster vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.|||Participants|||Number
2801749|NCT00514683|Secondary|Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).|Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.|day 365 and day 729|Randomised set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2801750|NCT00514683|Secondary|Time to Progression|"Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC - Randomised set|||Days||95% Confidence Interval|Median
2801751|NCT00514683|Secondary|Survival (Death Due to Respiratory Cause, and Lung-transplant Free)|"Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set|||percentage of participants|||Number
2801752|NCT00514683|Secondary|Time to First Occurrence of IPF Exacerbation|"This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set|||percentage of participants|||Number
2801753|NCT00514683|Secondary|Occurrences of IPF Exacerbations Per Patient Per Year|Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks|52 weeks|OC-Randomised set|||Exacerbations Per Year||Standard Deviation|Mean
2801754|NCT00514683|Secondary|Number of Patients With at Least One IPF Exacerbation|Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks|52 weeks|OC-Randomised set|||participants|||Number
2801755|NCT00514683|Secondary|Change From Baseline in IC|Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
2801756|NCT00514683|Secondary|Change From Baseline in VC|Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
2801757|NCT00514683|Secondary|Change From Baseline in TGV|Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
2801758|NCT00514683|Secondary|Change From Baseline in RV|Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
2801759|NCT00514683|Secondary|Change From Baseline in TLC|Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
2801760|NCT00514683|Secondary|St George's Respiratory Questionnaire (SGRQ) Responder|St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case|52 weeks|Worst case - Randomised set|||percentage of participants|||Number
2801761|NCT00514683|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||units on a scale||Standard Error|Mean
2801762|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Impacts|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF - Randomised set|||units on a scale||Standard Error|Mean
2801763|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Symptoms|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||units on a scale||Standard Error|Mean
2801764|NCT00514683|Secondary|Change From Baseline in SGRQ Total Score|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||units on a scale||Standard Error|Mean
2801765|NCT00514683|Secondary|Absolute Change From Baseline in FEV1/FVC|"Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||percentage of FVC||Standard Error|Mean
2801766|NCT00514683|Secondary|Absolute Change From Baseline in MRC Dyspnea Scale by Categories|"Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:~Decrease~No Change~Increase"|Baseline and 52 weeks|LOCF- Randomised|||percentage of participants|||Number
2801767|NCT00514683|Secondary|Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)|"Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||Units on a scale||Standard Error|Mean
2801768|NCT00514683|Secondary|Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)|"Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||Units on a scale||Standard Error|Mean
2801769|NCT00514683|Secondary|Absolute Change From Baseline in Distance Walk (6-MWT)|Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set|||Meter||Standard Error|Mean
2801770|NCT00514683|Secondary|Absolute Change From Baseline in DLCO by Categories|"Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:~Decrease > 15% or > 1~Change <= 15% or <= 1~Increase > 15% or > 1"|Baseline and 52 weeks|LOCF Randomized set|||percentage of patients|||Number
2801771|NCT00514683|Secondary|Absolute Change From Baseline in DLCO|"Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||mmol.min^−1.kPa^−1||Standard Error|Mean
2801772|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a) O2 by Categories|"Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set|||percentage of participants|||Number
2801773|NCT00514683|Secondary|Absolute Change From Baseline in PaO2 by Categories|"Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set|||percentage of participants|||Number
2801774|NCT00514683|Secondary|Absolute Change From Baseline in PaCO2|Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set|||mmHg||Standard Error|Mean
2801775|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a)O2|Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set|||mmHg||Standard Error|Mean
2801776|NCT00514683|Secondary|Absolute Change From Baseline in PaO2|Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set|||mmHg||Standard Error|Mean
2801777|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest by Categories|"Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:~SpO2 (non-invasive) at 52 weeks:~Decrease > 4% SpO2~Change within +/- 4% SpO2~Increase > 4% SpO2"|Baseline and 52 weeks|LOCF-Randomised set|||percentage of participants|||Number
2801778|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest|"Absolute change from baseline in oxygen saturation (SpO2) at rest.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set|||Percentage of SpO2||Standard Error|Mean
2801779|NCT00514683|Secondary|Survival (All Causes of Death and Lung-transplant Free)|"Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set|||participants|||Number
2801780|NCT00514683|Secondary|Number of Participants With Change From Baseline in FVC by Categories|"Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:~Decrease > 10% or 200mL~Change within <= 10% or <=200 mL~Increase > 10% or 200mL"|Baseline and 52 weeks|LOCF-Randomised set|||participants|||Number
2801781|NCT00514683|Secondary|Relative Change From Baseline in FVC|"Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region"|Baseline and 52 weeks|LOCF-Randomised set|||percentage change||Standard Error|Mean
2801782|NCT00514683|Secondary|Relative Change From Baseline in FVC%Pred|"Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set|||percentage of change||Standard Error|Mean
2801783|NCT00514683|Secondary|Absolute Change From Baseline in FVC|"Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set|||Liters||Standard Error|Mean
2801784|NCT00514683|Secondary|Absolute Change From Baseline in FVC%Pred|"Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|"Last Observation Carried Forward (LOCF): This method was used for the replacement of missing values.~Randomised set: This patient set includes all randomised patients whether treated or not."|||percentage of predicted FVC||Standard Error|Mean
2801785|NCT00514683|Primary|Rate of Decline in FVC|"Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.~The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time."|Baseline until 52 weeks|"Observed Case (OC): This method was used for the replacement of missing values.~Randomised set: This patient set includes all randomised patients whether treated or not."|||Liters/year||Standard Error|Mean
2801786|NCT00514592|Secondary|Any Stroke Before Carotid Enderarterectomy|Same as primary endpoint, but includes stroke of all types.|Before CEA||||participants|||Number
2801787|NCT00514592|Primary|Ipsilateral Ischemic Stroke Before Carotid Endarterectomy|Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.|Before CEA||||participants|||Number
2801788|NCT00514514|Secondary|Efficacy Event Data After Month 12 to Month 60|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|Events starting after Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Participants|||Number
2801789|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 60|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed were previously enrolled in the core study and had at least one serum creatinine value in the extension period.|||mg/dl||95% Confidence Interval|Least Squares Mean
2801790|NCT00514514|Secondary|GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:~For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801791|NCT00514514|Secondary|GFR at Month 60 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801792|NCT00514514|Secondary|GFR Calculated Via Nankivell Formula at Month 60|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 60|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801793|NCT00514514|Secondary|Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)|The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Percent risk||Standard Deviation|Mean
2801794|NCT00514514|Secondary|Efficacy Event Data Baseline 2 (Month 3) to Month 12|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Participants|||Number
2801833|NCT00513695|Primary|Microscopic Pathologic CR (pCR) Rate|Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.|At the time of surgery||||percent of evaluable participants||95% Confidence Interval|Number
2801795|NCT00514514|Secondary|Efficacy Event Data From Baseline 2 (Month 3) to Month 6|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 6|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.|||Participants|||Number
2801796|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 12|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed required at least one post randomization value. ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization|||mg/dl||95% Confidence Interval|Least Squares Mean
2801797|NCT00514514|Secondary|GFR at Month 12 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801798|NCT00514514|Secondary|GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:~For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801799|NCT00514514|Secondary|GFR Via Nankivell Formula at Month 12 - All Regimens|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801800|NCT00514514|Primary|GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen|Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.|||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
2801801|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.|||% (n/N)||95% Confidence Interval|Number
2801827|NCT00513708|Primary|"Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare)"|"Linkage to alcohol behavioral therapy counseling (i.e., aftercare) was defined as: arriving for the first outpatient chemical dependency counseling visit, being admitted to an inpatient or residential chemical dependency treatment facility, or attending at least one meeting of a help-help program such as Alcoholics Anonymous."|1 month|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, linked to aftercare or not linked to aftercare) available at the 30-day follow-up."|||participants|||Number
2801828|NCT00513695|Secondary|Number and Percent of Subjects Reporting Adverse Events|See Adverse Events section for more details.|28 days after the last dose of study drug||||Participants|||Count of Participants
2801802|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.|||% (n/N)||95% Confidence Interval|Number
2801803|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.|||% (n/N)||95% Confidence Interval|Number
2801804|NCT00514449|Secondary|Changes in Grey Matter Deficit|Gray matter volume changes (in cc) were measured using structural MRI. Changes were reported as gray matter volume in cc. Note: Assessment of blood oxygenation level dependent (BOLD) changes using fMRI were erroneously included in the original study record.|Baseline, Week 18|Analysis included on all participants on whom baseline and week 18 data were collected. Valacyclovir and placebo groups|||cm^3||Standard Deviation|Mean
2801805|NCT00514449|Primary|Cognitive Function Neuropsychological Battery (Gur Battery)|All results are given as the mean difference between an 18 week follow-up and the baseline battery administrations.This is a computerized test that measures both accuracy and response times. A range for response times is not available because of individual variabilities. Accuracy scores can vary for each test: Working memory accuracy range was 0-16. Verbal memory accuracy range was 0-20. For both, the higher the score the better. No cut offs are available|Baseline, Week 18||||units on a scale||Standard Deviation|Mean
2801806|NCT00514449|Primary|PANSS Positive and Negative Syndrome Scale for Schizophrenia|This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains.|Baseline, Weeks 2, 4, 6, 10, 14, 18|Comparative analysis of active drug versus placebo|||Scores on the scale||Standard Deviation|Mean
2801807|NCT00514215|Secondary|Immune Function and Cancer-specific Response|Number of Participants with CT-guided biopsy & Peritumoral GM-CSF. The number of IFNγ secreting T-cells was measured by a direct EliSpots at 10:1 E:T ratio to define the kinetics of the CTL responses from pre-CI to day 63 post CI.|Days 1 & 63|only those with metastatic Renal Cell carcinoma|||Participants|||Count of Participants
2801808|NCT00514215|Secondary|Toxicity of Grade 1 or Higher|Number of Participants with Toxicity of Grade 1 or Higher as defined by CTCAE v2|Days 11, 32, 43, & 63||||Participants|||Count of Participants
2801809|NCT00514215|Secondary|Clinical Response as Measured by CT Criteria|CT-guided biopsy. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard definition for progressive disease (PD) remains as evidence of neTw or growing tumors.|Days 1 & 32|only those with metastatic Renal Cell carcinoma|||Participants|||Count of Participants
2801810|NCT00514215|Primary|Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry|CT-guided biopsy & Peritumoral GM-CSF. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard definition for progressive disease (PD) remains as evidence of neTw or growing tumors.|Days 1 & 32|Patients who had metastatic Renal Cell carcinoma|||Participants|||Count of Participants
2801811|NCT00514137|Secondary|Toxicity|Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.|From the time of first treatment to up to 30 days after the last day of study drug treatment||||participants|||Number
2801812|NCT00514137|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|From the documentation of response until the date of progression|No analysis was done because there were no confirmed responses.||||||
2801813|NCT00514137|Secondary|Event-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2801829|NCT00513695|Secondary|Overall Survival|Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years.|Up to 2 years||||survival probability||95% Confidence Interval|Number
2801830|NCT00513695|Secondary|Time to Disease Progression|Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.|Up to 2 years||||days||95% Confidence Interval|Median
2801814|NCT00514137|Primary|The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])|"A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart.~A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis.~A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas.~A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma."|Every 6 weeks from the first initiation of therapy up to 72 weeks|All 13 participants were evaluable for a response|||participants|||Number
2801815|NCT00514020|Primary|"Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])"|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.|every 8 weeks to progression|"Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous good risk genotype group. One patient was not evaluable for response."|||participants|||Number
2801816|NCT00513799|Secondary|Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|4 month follow-up||||Participants|||Number
2801817|NCT00513799|Secondary|Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection|Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.|1, 4 and 6 month follow-ups|Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached.|||Participants|||Number
2801818|NCT00513799|Primary|Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|1 month follow-up||||Participants|||Number
2801819|NCT00513747|Secondary|Time to First Treatment Survival in Low Risk Patients|"Time to First Treatment Survival in low risk patients (registration to first treatment or death) >~• Events were defined as the start of first treatment or death from any cause. Patients who didn't receive their first treatment were censored at their last known follow-up."|Up to 72 months|Low Risk patients are included in this analysis.|||months||95% Confidence Interval|Median
2801820|NCT00513747|Secondary|Overall Survival in Low Risk Patients|"Overall survival in low risk patients (registration to first treatment or death) >~• Events were defined as death from any cause. Low risk Patients who were alive were censored at their last known follow-up."|Up to 72 months|Low Risk patients are included in this analysis.|||months||95% Confidence Interval|Median
2801821|NCT00513747|Secondary|Number of Patients With Mutated and Unmutated IgVH Genes|Number of patients with mutated and unmutated IgVH genes are reported below.|Once at baseline|All patients are included in this analysis.|||Participants|||Count of Participants
2801822|NCT00513747|Primary|Overall Survival (OS) for High Risk Patients|Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to death from any cause. Estimates were not stratified. Patients who did not experience this primary outcome had their survival times censored at their last follow-up.|Up to 72 months|Randomized High Risk patients are included in this analysis.|||months||95% Confidence Interval|Median
2801823|NCT00513747|Primary|Disease-Free Survival in High Risk Patients|"Kaplan-Meier analysis was conducted to estimate disease free survival defined as: >~Arm A: Time from randomization until Second Treatment (first relapse) or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up. >~Arm B: Time from randomization until First Treatment (first relapse) or death whichever comes first. Events were defined as the start of first treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up."|Up to 72 months|Randomized High Risk patients are included in this analysis.|||months||95% Confidence Interval|Median
2801824|NCT00513747|Primary|Time to Second Treatment in High Risk Patients|Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to second treatment or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.|Up to 72 months|Randomized High Risk patients are included in this analysis.|||months||95% Confidence Interval|Median
2801825|NCT00513708|Secondary|Completed Inpatient Treatment|"Completion of inpatient treatment was defined as being admitted to and successfully discharged from an inpatient alcohol treatment program (e.g., a 28-day program). Participants who left the inpatient program against medical advice or who received an administrative discharge were not considered to have successfully completed the inpatient program."|90 days|"There were 50 participants in each arm; the number of participants analyzed represents the number of those 50 in each arm who were admitted to an inpatient treatment program (e.g., a 28-day program)."|||Participants|||Number
2801826|NCT00513708|Secondary|Relapse to Drinking|"Relapse to drinking was defined as the consumption of one or more standard drinks (approximately 12 grams of ethanol)during the first 30 days following discharge from the inpatient detoxification unit. The date of discharge was considered to be Day 1."|30 days|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, relapse or no relapse) available at the 30-day follow-up."|||participants|||Number
2801834|NCT00513682|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72- hour period in either washout phase or treatment phase. Nitrogen intake was calculated as protein intake/6.25. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.|||Percent CNA||Standard Deviation|Mean
2801835|NCT00513682|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period in either washout phase or treatment phase. Mean percent CFA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.|||Percent CFA||Standard Deviation|Mean
2801836|NCT00513617|Secondary|Fetal Hemoglobin|Fetal hemoglobin (HbF) as measured by the Advia machine|12 weeks after randomization|||||||
2801837|NCT00513617|Secondary|Endothelin-1|Endothelin-1 is a potent vasoconstrictor and pro-inflammatory agent which is elevated in SCD patients|12 weeks after randomization|||||||
2801838|NCT00513617|Secondary|8-iso-PGF2a|8-iso-PGF2a is a measure of lipid peroxidation and oxidative damage in vivo measured by enzyme immunoassay kit from Cayman chemical|12 weeks after randomization|||||||
2801839|NCT00513617|Primary|Mean Corpuscular Hemoglobin Concentration|Mean corpuscular hemoglobin concentration as measured by an Advia machine|12 weeks after randomization||||g/dL||Standard Deviation|Mean
2801840|NCT00513617|Primary|Nitric Oxide|Nitric oxide from plasma amino acids|12 weeks after randomization|All subjects that were randomized and dosed - ITT No imputation used.|||uM||Standard Deviation|Mean
2801841|NCT00513617|Secondary|Soluble Vascular Cell Adhesion Molecule|Soluble vascular cell adhesion molecule (sVCAM) a vascular adhesion molecule|12 weeks after randomization|||||||
2801842|NCT00513617|Primary|Gardos Channel Activity|Gardos channel activity: a calcium (Ca2+)-activated K+ channel|12 weeks after randomization|All subjects that were randomized and dosed - Intent to Treat (ITT) No imputation used.|||mmol/10^13 cells x min||Standard Deviation|Mean
2801843|NCT00513604|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years||||Participants|||Number
2801844|NCT00513604|Primary|Clinical Response|Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012||||Participants|||Number
2801845|NCT00513526|Secondary|Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series||Weeks 0, 28 and 76|Samples for this outcome measure were not analyzed due to loss of funding for the central lab.||||||
2801846|NCT00513526|Secondary|HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2801847|NCT00513526|Secondary|HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2801848|NCT00513526|Secondary|HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2801849|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
2801850|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
2801851|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
2801852|NCT00513526|Secondary|HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine|||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
2801853|NCT00513526|Secondary|Longitudinal Changes in Plasma HIV-1 RNA From Baseline|Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.|||copies/ml||Inter-Quartile Range|Median
2801854|NCT00513526|Secondary|Longitudinal Changes in CD4+ Cell Count From Baseline|CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.|||cells/uL||Inter-Quartile Range|Median
2801855|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.|||proportion of participants||95% Confidence Interval|Number
2801856|NCT00513526|Primary|Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine||All study visits|Intention to treat (i.e., received at least one dose of the vaccine)|||participants|||Number
2801857|NCT00513500|Secondary|Number of Children Who do Not Respond to Treatment for Pneumonia||one year|Based on number classified as having pneumonia. Analysis was per intention to treat|||participants|||Number
2801858|NCT00513500|Primary|Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)||one year|The participants analyzed was based on children reported with fever. Analysis was per intention to treat.|||participants|||Number
2801859|NCT00513500|Primary|Number of Children Who Received Early and Appropriate Treatment for Pneumonia.|Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom|one year|The number of participants determined for this analysis was based on those classified as pneumonia. The analysis was based on an intent-to-treat basis.|||partcipants|||Number
2801860|NCT00513474|Secondary|Graft-versus-host and Host-versus-graft Immune Responses|Laboratory tests such as limited dilution assay (LDA) were to be performed to assess graft-versus-host and host-versus-graft immune responses.|Days -2, 0, and Days 14, 21 and 35 days post-transplant|Due to laboratory and budgetary issues the planned laboratory testing and assays were not performed and no data were collected.||||||
2801861|NCT00513474|Secondary|Number of Participant With Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|Up to 71 months|Safety population included all participants who received at least one dose of protocol specified treatment and were in remission at the time of transplant.|||Participants|||Count of Participants
2801862|NCT00513474|Secondary|Uric Acid Levels|Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant.|Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6|Intent-to-treat population with data available for analyses.|||mg/dL||Standard Deviation|Mean
2801863|NCT00513474|Primary|Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)|"aGVHD severity was determined using International Bone Marrow Transplant Registry (IBMTR) scale stage and grade of the skin, liver and gut. Stage 1: Skin=maculopapular rash <25% of body surface; Liver=Bilirubin 2-3 mg/dL and Gut=500-999 mL diarrhea/day or peristent nausea with histologic evidence of GvHD. Stage 2: Skin=maculopapular rash 25-50% of body surface; Liver=Bilirubin 3.1-6 mg/dL and Gut=1000-1499 mL diarrhea/day. Stage 3: Skin=maculopapular rash >50% of body surface; Liver=Bilirubin 6.1-15 mg/dL and Gut=≥1500 mL diarrhea/day. Stage 4: Skin=generalized erythroderma with bulla formation; Liver=Bilirubin >15 mg/dL and Gut=severe abdominal pain.~Grade 1: Stage 1-2 rash; no liver or gut involvement. Grade II: Stage 3 rash, or stage 1 liver involvement, or stage 1 gut involvement. Grade III: None to stage 3 skin rash with stage 2-3 liver, or stage 2-4 gut involvement. Grade IV: Stage 4 skin rash, or stage 4 liver involvement."|Up to 71 months|Intent-to-treat participants included in the analyses.|||percentage of participants|||Number
2801864|NCT00513461|Secondary|Changes in Quality of Life - Mental Score|Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||scores on a scale||Standard Deviation|Mean
2801865|NCT00513461|Secondary|Changes in Quality of Life - Physical Score|Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||units on a scale||Standard Deviation|Mean
2801866|NCT00513461|Secondary|HCV RNA|Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||IU/mL||Standard Deviation|Mean
2801867|NCT00513461|Secondary|Change in Markers of Liver Disease - ALT|ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||IU/L||Standard Deviation|Mean
2802301|NCT00510198|Secondary|Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations|To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm|up to five years|Study was stopped early, therefore secondary objectives were not analyzed.||||||
2801868|NCT00513461|Secondary|Change in Markers of Liver Disease - AST|AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||IU/L||Standard Deviation|Mean
2801869|NCT00513461|Secondary|Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)|Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µg/mL||Standard Deviation|Mean
2801870|NCT00513461|Secondary|Change in SAMe Metabolites - Malondialdehyde (MDA)|malondialdehyde|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
2801871|NCT00513461|Secondary|Change in SAMe Metabolites - Plasma GSH|Plasma GSH will be measured using HPLC with fluorescence detection.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
2801872|NCT00513461|Secondary|Change in SAMe Metabolites - Total Homocysteine (tHcy)|Total homocysteine (tHcy)|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
2801873|NCT00513461|Secondary|Change in SAMe Metabolites - Methionine|Methionine will be measured using HPLC with fluorescence detection.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||µmol/L||Standard Deviation|Mean
2801874|NCT00513461|Secondary|Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)|S-adenosylhomocysteine (SAH)|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||nmol/L||Standard Deviation|Mean
2801875|NCT00513461|Secondary|SAMe|Change in SAMe levels|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||nmol/L||Standard Deviation|Mean
2801876|NCT00513461|Secondary|Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma|AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||percentage of AFP-L3/AFP||Standard Deviation|Mean
2801877|NCT00513461|Secondary|Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma|To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||ng/mL||Standard Deviation|Mean
2801878|NCT00513461|Primary|Change in Serum AFP Levels|Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.|Baseline to week 24|All subjects who completed the week 24 visit as planned were included in the data anlysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.|||ng/mL||Standard Deviation|Mean
2801879|NCT00513435|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival.|Up to 12 weeks||||Days||Full Range|Median
2801880|NCT00513435|Primary|Overall Response Rate|Response was determined as inicated in the protocol.|From the start of treatment for up to 12 weeks||||participants|||Number
2801881|NCT00513409|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value|Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.|||subjects|||Number
2801882|NCT00513409|Secondary|Anti-hepatitis A Virus Antibodies Concentration|Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results|||mIU/mL||95% Confidence Interval|Geometric Mean
2801883|NCT00513409|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results|||subjects|||Number
2801884|NCT00513409|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results|||subjects|||Number
2801885|NCT00513409|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
2801886|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)||||subjects|||Number
2801887|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)||||subjects|||Number
2801888|NCT00513409|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after the administration of any study vaccine dose||||subjects|||Number
2801889|NCT00513409|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.~Fever was defined as rectal temperature ≥ 38 degrees Celsius."|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.|||subjects|||Number
2801890|NCT00513409|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.|||subjects|||Number
2801891|NCT00513409|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)|Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.|||subjects|||Number
2801892|NCT00513370|Secondary|Change in Resource Utilization Outcomes and Costs From Baseline as Measured by the Health Care Resource (HCR) Questionnaire||16 and 24 weeks|||||||
2801893|NCT00513370|Secondary|Change in Productivity Outcomes and Costs From Baseline as Measured by the Health and Labour Questionnaire (HLQ)||16 and 24 weeks|||||||
2801894|NCT00513370|Secondary|Change From Baseline on the EuroQol (EQ-5D) Quality of Life Questionnaire||16 and 24 weeks|||||||
2801895|NCT00513370|Secondary|Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks|Change in the Beck Depression Inventory from Baseline. The BDI-II contains 21 questions and is scored from 0-63; higher scores indicate more severe depression symptoms.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
2801896|NCT00513370|Secondary|Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0|Number of subjects achieving a Dermatology Life Quality Index (DLQI) score of 0 (indicating total lack of impairment). The DLQI consists of 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
2801897|NCT00513370|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks|Mean change in the Dermatology Life Quality Index (DLQI) from Baseline. The questionnaire contains 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired; the minimum clinically important difference is 2.3 to 5.7 point change.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
2801898|NCT00513370|Secondary|Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks|Mean change in the Patient's Global Assessment of Joint Pain from Baseline, as assessed on a 100-mm visual analog scale where 0 mm = no pain and 100 mm = pain as bad as it could be.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
2801899|NCT00513370|Secondary|Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks|Mean change in the number of swollen joints from Baseline. 76 joints were evaluated for swelling, corresponding to all joints evaluated for tenderness except for the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||number of joints||Standard Deviation|Mean
2801900|NCT00513370|Secondary|Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks|Mean change in the number of tender joints from Baseline. 78 joints were evaluated for tenderness, including all 76 joints evaluated for swelling plus the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||number of joints||Standard Deviation|Mean
2802333|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percent of glycosylated hemoglobin||Standard Deviation|Mean
2801901|NCT00513370|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response|PASI 50/75/90/100 is a >=50% / >=75% / >=90% / 100% improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
2801902|NCT00513370|Secondary|Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks|Mean Change from Baseline in Physician Global Assessment of Arthritic Disease Activity as measured on a 100-mm visual analog scale where 0 mm = no arthritis activity and 100 mm = extremely active arthritis.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||units on a scale||Standard Deviation|Mean
2801903|NCT00513370|Secondary|"Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of Clear or Clear or Minimal"|"Number of subjects achieving a response of Clear or Clear or Minimal on the Physician's Global Assessment for Psoriasis. This is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-severe, 5-very severe."|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
2801904|NCT00513370|Secondary|Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)|Number of subjects with improvement on the Physician's Global Assessment for Psoriasis (PGA). The PGA is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject, where 0 = clear and 6 = very severe. Improvement is defined as a reduction in PGA score.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
2801905|NCT00513370|Secondary|Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean percent change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||percent change||Standard Deviation|Mean
2801906|NCT00513370|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point|||unit on a scale||Standard Deviation|Mean
2801907|NCT00513370|Primary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks|PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 weeks|Observed Cases - subjects with nonmissing values at each time point|||participants|||Number
2801908|NCT00513357|Primary|Change in Appetite as Measured by ESAS|Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation [± 3 days] to 4 week evaluation [± 3 days], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.|Baseline and at 4 weeks||||units on a scale||Standard Deviation|Mean
2801909|NCT00513344|Secondary|Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake|"Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff.~An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia."|baseline and 2 hours||||percentage of baseline||Standard Deviation|Mean
2801910|NCT00513344|Primary|Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake|Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser.|Baseline and 2 hours|"Taking into account the fact that there is no background data and that we need to have accurate evaluation of central tendency and dispersion, a minimum of five complete subjects are needed.~Data from all randomized subjects were considered in the intention to treat model (for the primary outcome)."|||percentage of the pulse wave amplitude||Standard Error|Mean
2801911|NCT00513305|Secondary|Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate|The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here.|Baseline through 12 months||||Proportion of Participants||95% Confidence Interval|Number
2801912|NCT00513305|Secondary|Number of Participants Who Experienced Induction (Thirty-Day) Mortality|The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here.|Up to 30 days following start of study drug treatment||||Participants|||Number
2801913|NCT00513305|Secondary|Number of Participants Who Experienced Early Death|Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here.|14 days from start of study drug treatment||||Participants|||Number
2801926|NCT00513240|Secondary|Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose (Maximum EPO Plasma Concentration)||24 hours after first EPO dose.|Three patients had pharmacokinetic data obtained; 1 placebo and 2 patients who received EPO 1000 units/kg. Pharmacokinetic modeling was not performed because of these small patient numbers; however, maximum EPO plasma concentrations were measured in the EPO group. Outcome does not apply to the Placebo group and as such they were not analyzed.|||mIU/mL||Full Range|Mean
2801914|NCT00513305|Secondary|Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate|RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.|From Baseline (randomization) through 24 months following Baseline|Population analyzed are the subjects who who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR)during the course of the study|||Proportion of participants||95% Confidence Interval|Number
2801915|NCT00513305|Secondary|Number of Participants Who Died or Were Censored by 24 Months|This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)|From Baseline through 24 months following Baseline||||Participants|||Number
2801916|NCT00513305|Primary|Percentage of Participants in Complete Remission (CR)|The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.|From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator|Intention to treat (ITT) Analysis Set|||Percentage of participants in CR|||Number
2801917|NCT00513292|Secondary|Overall Survival (OS)|OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.|From time to registration to death, assessed up to 5 years|All patients that began protocol therapy were included in this analysis.|||months||95% Confidence Interval|Median
2801918|NCT00513292|Secondary|Disease-free Survival (DFS)|DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.|From time to registration to time of event, assessed up to 5 years|All patients that began protocol therapy are included in this analysis|||months||95% Confidence Interval|Median
2801919|NCT00513292|Secondary|Breast Conservation|"Surgery was categorized as breast conserving surgery (Partial Mastectomy) or non-conserving surgery (Total Mastectomy or Modified Radical Mastectomy). Reported below is the percentage of patients receiving Partial Mastectomy. This was calculated by dividing the number of patients receiving Partial Mastectomy by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage)."|From time surgery to up to 5 years|All patients that underwent breast surgery were included in this analysis.|||percentage of participants|||Number
2801920|NCT00513292|Secondary|Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week|Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)].|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.|||percent||Inter-Quartile Range|Median
2801921|NCT00513292|Secondary|LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)].|At 12 week||||percent||Inter-Quartile Range|Median
2801922|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in LVEF at Week 24|The summary of asymptomatic changed in LVEF.|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.|||Percentage of Participants|||Number
2801923|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12|The summary of asymptomatic decrease in LVEF.|Baseline, at 12 week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.|||Percentage of participants|||Number
2801924|NCT00513292|Secondary|Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy|pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).|Up to 5 years|All patients who had clinical N1-3 disease prior to the start of treatment are included in the analysis of the pCR rate in the breast and axillary lymph nodes.|||Percentage (95% confidence Interval)||95% Confidence Interval|Number
2801925|NCT00513292|Primary|pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy|Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.|Up to 5 years|All patients who started study treatment are included in the analysis of the primary endpoint.|||percentage of participants||95% Confidence Interval|Number
2801927|NCT00513240|Secondary|EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).||72 hours postoperatively.||||minutes||Full Range|Mean
2802385|NCT00509925|Secondary|Body Weight|Body weight after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kg||Standard Deviation|Mean
2801928|NCT00513240|Primary|Scores on Bayley Scales of Infant Development III at Age 1 Years.|3 domains of the Bayley Scales of Infant Development III: Cognitive, Language and Motor Minimum score = 45, maximum score = 155; Population mean = 100, SD = 15; Higher scores are indicative of better outcomes Language scores are reflective of receptive communication and expressive communication subscales. Motor scores are reflective of fine motor and gross motor subscales.|1 year postoperatively||||units on a scale||Standard Deviation|Mean
2801929|NCT00513240|Primary|Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI|"TMS is a measure of developmental maturity of the brain as assessed from T1 and T2-weighted images, grading myelination, cortical infolding, involution of the germinal matrix, and presence of bands of migrating glial cells. The brain MRIs were reviewed for infarction, hemorrhage, white matter injury (WMI), or dural sinovenous thrombosis (DVST). Injuries in each category are scored 0 for none, 1 for mild, 2 for moderate, 3 for severe. The score in each category is then multiplied by a proposed outcome significance multiplier. A total injury score of 0 signifies no injury, 1-5 a mild injury, 6-10 a moderate injury, and >10 a severe injury. Range of scores is 0 - 51. Lower scores indicate less injury.~The results present the relative difference of this score between the pre- and post-operative MRI. This was calculated as ((Post-operative MRI TMS - Pre-operative MRI TMS) / (Absolute(Pre-operative MRI TMS)) ). The proportion is then converted into a percentage."|7 days postoperatively.|Preoperative and postoperative MRIs were available to be scored on 33 subjects.|||Percentage||Full Range|Mean
2801930|NCT00513071|Secondary|N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers||At baseline, at 6 hours, at each course (day 1), and at 2 years|Bone marker data was not collected.||||||
2801931|NCT00513071|Secondary|Relationship Between Changes in Laboratory Correlates and Response and Survival||Up to 2 years|Laboratory correlates were not collected.||||||
2801932|NCT00513071|Secondary|Toxicity Data|Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.|Up to 2 years|One patient died unexpectedly at home. No autopsy was performed. Treatment was listed as possible cause along with diabetes mellitus, morbid obesity, hypertension, hypercholesterolemia, and renal failure.|||participants|||Number
2801933|NCT00513071|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From start of treatment, up to 5 years||||Months||95% Confidence Interval|Median
2801934|NCT00513071|Secondary|Time to Treatment Failure|Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From first day of treatment until discontinuation of treatment, up to 2 years||||Months||95% Confidence Interval|Median
2801935|NCT00513071|Secondary|Progression-free Survival (PFS)|PFS defined as time between start of treatment and disease progression or death. Using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment until progression or death, up to 2 years||||Months||95% Confidence Interval|Median
2801936|NCT00513071|Primary|PSA Response Rate|Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR|PSA measured every 4 weeks||||percentage of participants|||Number
2801937|NCT00513019|Primary|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.||||units on a scale||Standard Deviation|Mean
2801938|NCT00512902|Secondary|Change in Modified Rodnan Skin Score (MRSS)|No measures of dispersion was available as data were lost. The range of this measure is 0 to 51 and measures the extent of skin thickening with higher numbers representing thickening.|Baseline vs. Endpoint||||units on a scale||Standard Deviation|Mean
2801939|NCT00512902|Secondary|Change in DLco|DLCO (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) is the extent to which oxygen passes from the air sacs of the lungs into the blood. Commonly, it refers to the test used to determine this parameter.|Baseline vs. Endpoint (1 year)||||Percent predicted||Standard Deviation|Mean
2801940|NCT00512902|Secondary|Change in TLC (Total Lung Capacity)|No measures of dispersion was available for TLC as data were lost. This describes the total lung capacity as a percent of predicted.|Baseline vs. Endpoint (1 year)||||Percent predicted||Standard Deviation|Mean
2801941|NCT00512902|Secondary|Change in FVC (Forced Vital Capacity)|Measures the amount of air breathed out as a percent of predicted.|Baseline vs. Endpoint (1 year)||||Percent predicted||Standard Deviation|Mean
2801942|NCT00512902|Primary|Treatment-related Adverse Events|Treatment-related adverse events requiring discontinuation.|Baseline vs. Endpoint (1 year)||||participants|||Number
2801943|NCT00512876|Secondary|Size and Extent of Corneal Neovascularization|computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.|24 weeks||||percentage change||Standard Deviation|Mean
2801944|NCT00512876|Primary|Adverse Events (Ocular and Systemic)||24 weeks||||participants|||Number
2801976|NCT00512252|Secondary|Time to Neutrophil Recovery|Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3.|42 days|This analysis includes patients who achieved a CR or a CRi.|||days||Full Range|Median
2801977|NCT00512252|Secondary|Safety and Tolerability of AMD3100 + MEC.|Treatment related mortality (deaths occurring during treatment)|42 days|The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study.|||participants|||Number
2801945|NCT00512798|Primary|Number of Patients With Clinical Anti-tumor Activity Phase II)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD|every 9 weeks to a maximum of 54 weeks|Patients who were available to measure response to the study drugs.|||participants|||Number
2801946|NCT00512798|Secondary|Patients With Inhibition of NF-kB (Phase II)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Patients with advanced, incurable melanoma who are chemotherapy-naive and patients who had undergone prior chemotherapy with either Dacarbazine or Temozolomide with treatment failure. No degree of inhibition of NF-kB was observed. Phase II not completed due to lack of efficacy.|||participants|||Number
2801947|NCT00512798|Secondary|Patients With Clinical Anti-tumor Activity (Phase I)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 9 weeks up to a maximum of 54 weeks|Patients who received treatment and who were available for measurement of lesions.|||participants|||Number
2801948|NCT00512798|Secondary|Patients With Inhibition in NF-kB Activation (Phase I)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Phase I patients for whom blood was taken at baseline,on day 8 and on day 29 of each cycle. There was no correlation of change in NF-kB activation with changes in tumor tissue|||participants|||Number
2801949|NCT00512798|Primary|Optimal Doses of Temozolomide and Bortezomib (Phase I)|The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide|up to 42 days|All Phase I patients who received the study drugs|||mg/m2|||Number
2801950|NCT00512707|Other Pre-specified|Change From Baseline in Sex Hormone Binding Globulin (SHBG)||Week 0, Week 14|All available data expressed as absolute value at the given time-point.|||nmol/L||Standard Deviation|Mean
2801951|NCT00512707|Other Pre-specified|Change From Baseline in Free Testosterone|Free testosterone levels were calculated from total testosterone at screening and equilibrium dialysis at randomization and at trial end.|Week 0, Week 14|All available data expressed as absolute value at the given time-point.|||pg/mL||Standard Deviation|Mean
2801952|NCT00512707|Other Pre-specified|Change From Baseline in Total Testosterone|Total testosterone levels were measured between 7:30 and 10:10 a.m. using a liquid chromatography-tandem mass spectrometry assay certified by the Centers for Disease Control and Prevention's Hormone Standardization Program.|Week 0, Week 14|All available data expressed as absolute value at the given time-point.|||ng/dL||Standard Deviation|Mean
2801953|NCT00512707|Secondary|Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Positive Affects Ratio (PAR), ranging from 0 to 1, is the proportion of total scores (sum of all 8 domains) that is positive (sum of 4 positive domains). Higher PAR represents better affectivity.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||ratios||Standard Deviation|Mean
2801954|NCT00512707|Secondary|Change From Baseline in Derogatis Affects Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a 40-item mood inventory and consists of 4 positive affect dimensions (joy, contentment, vigor, and affection) as well as 4 negative affect dimensions(anxiety, depression, guilt, and hostility). Each domain was calculated as the sum of 5-items and could range from 0 to 20, wherein higher scores indicate greater affectivity.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801955|NCT00512707|Secondary|Change From Baseline in Psychological General Well-Being Index Score (PGWBI)|Well-being and mood were assessed using the Psychological General Well-Being Index (PGWBI), a 22-item questionnaire that evaluated six dimensions of self-reported wellness: Anxiety (5 questions), Depressed Mood (3 questions), Positive Well-Being (4 questions), Self Control (3 questions), General Health (3 questions), and Vitality (4 questions). Higher scores in each dimension reflect increasing well-being. A global score (ranging from 0 (poor QoL) to 110 (good QoL)) was calculated as the sum of each domain score. The global score and those of its 6 dimensions were normalized to a 100% scale to facilitate comparison.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801956|NCT00512707|Secondary|Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF)|CAncer Rehabilitation Evaluation System-short form (CARES-SF) marital interaction scale consists of 6 items (range from 0 (best) to 4) and mean of these 6 questions was used to determine intimacy and partner interaction. Lower CARES-SF scores correspond with improved marital interaction.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801957|NCT00512707|Secondary|Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED)|The Quality of Life for men with Erection Difficulties (QOL-MED) is a cross-cultural instrument to measure quality of life specific to male erection difficulties. The 18 items for this scale were generated from interviews with men with erection difficulties by TH Wagner in 1996. Higher QOL-MED scores reflect better quality of life. Scores were standardized to range of 0 to 100.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801978|NCT00512252|Primary|Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions||42 days|This outcome was not analyzed as data was not collected.||||||
2801958|NCT00512707|Secondary|Change From Baseline in Men's Sexual Health Questionnaire (MSHQ)|MSHQ, a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). A composite score is the sum of Ejaculation and Satisfaction domains, ranging from 7 to 65 (best), with higher score representing better sexual function and satisfaction.|Week 0, Week 8, Week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801959|NCT00512707|Secondary|Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP)|Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Higher percentage of Ejaculations or Satisfaction in successful sexual intercourse represents better sexual function.|Week 0, week 8, week 14|All available data expressed as absolute value at the given time-point.|||percentage of sexual intercourses||Standard Deviation|Mean
2801960|NCT00512707|Secondary|Change From Baseline in Sexual Encounter Profile (SEP)|Sexual Encounter Profile (SEP) diaries were used to assess frequency of sexual activity, sildenafil use, vaginal penetration, completion of intercourse with ejaculation, and overall satisfaction with sexual encounters. Minimum value is 0 with no maximum limit, wherein higher values representing better sexual encounter.|Week 0, week 8, week 14|All available data expressed as absolute value at the given time-point.|||events/week||Standard Deviation|Mean
2801961|NCT00512707|Secondary|Change From Baseline in Other Domains of International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.|Week 0, week 8, week 11, week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801962|NCT00512707|Primary|Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.|Week 0, week 8, week 11, week 14|All available data expressed as absolute value at the given time-point.|||units on a scale||Standard Deviation|Mean
2801963|NCT00512278|Secondary|Percentage of Participants Experiencing Medically Significant Infections|Medically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.|72 weeks from initiation of treatment||||Participants|||Count of Participants
2801964|NCT00512278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|The severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening|72 Weeks from initiation of treatment||||Participants|||Count of Participants
2801965|NCT00512278|Primary|Number of Participants Achieving Sustained Virological Response (SVR)|HCV RNA negativity at 24 weeks after completion of all study medications|24 weeks after completion of all study medications||||Participants|||Count of Participants
2801966|NCT00512278|Secondary|A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.|A comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.|24 weeks||||Participants|||Count of Participants
2801967|NCT00512278|Primary|A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.|A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms|72 Weeks from initiation of treatment|Included all patients who received at least one dose of treatment in both study arms|||percentage of participants|||Number
2801968|NCT00512252|Secondary|Relapse-free Survival|"This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause.~Kaplain-Meier estimate was used."|1 year|This excludes the 25 participants who had treatment failure.|||percentage of participants|||Number
2801969|NCT00512252|Secondary|Overall Survival||1 year||||percentage of participants|||Number
2801970|NCT00512252|Secondary|Treatment Failure|Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi.|42 days||||participants|||Number
2801971|NCT00512252|Secondary|Time to Progression||Every 6 months|"This outcome was not analyzed instead reason for treatment failure was analyzed as it provided better information on why the treatment did not work."||||||
2801972|NCT00512252|Secondary|Pharmacokinetics of AMD3100 on MEC||Day 1 - Phase 2 only|This was not performed.||||||
2801973|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)|Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.|Day 0||||percentage of AML blasts||Full Range|Median
2801974|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)|"Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.~Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC."|Day 0||||cells x 10^3/microliter||Full Range|Median
2801975|NCT00512252|Secondary|Time to Platelet Recovery|Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions.|42 days|This analysis includes patients who achieved a CR.|||days||Full Range|Median
2801979|NCT00512252|Primary|Phase II Only: Complete Response Rate of AMD3100 + MEC|"Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response.~Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi)."|42 days||||percentage of participants|||Number
2801980|NCT00512252|Primary|Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML|A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.|Completion of all patients in Phase I portion (232 days)|The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome.|||mcg/kg|||Number
2801981|NCT00512148|Secondary|Urodynamic Measurements and Long Term Safety|Safety results are summarized in the Adverse Events section of this listing.|month 12 through month 60|Tengion no longer exists following Chapter 7 bankruptcy in 2014. No data were analyzed.||||||
2801982|NCT00512148|Primary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|Clinical evaluation of adverse events experienced by patients enrolled in the trial.|through month 12|This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population. Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further data analysis will be made.|||participants|||Number
2801983|NCT00512148|Primary|Change in Maximum Detrusor Pressure From Baseline to 12 Months|Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.|baseline and 12 months|All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.|||centimeters of water (cm H2O)||95% Confidence Interval|Mean
2801984|NCT00512096|Primary|Number of Participants With Pathologic Complete Remission (pCR)|Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.|restaging with second and fourth 21-day cycles followed by surgery|Participants who completed chemotherapy without progression then had surgical resection.|||participants|||Number
2801985|NCT00511992|Secondary|Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.|CTCAE assessment of toxicity|2 years||||Participants|||Count of Participants
2801986|NCT00511992|Primary|Number of Patients Able to Complete 6 Cycles of Treatment.|Completion of cycle 6|2 years||||Participants|||Count of Participants
2801987|NCT00511914|Primary|Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).~According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages of Subjects||95% Confidence Interval|Number
2801988|NCT00511914|Primary|Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.~This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages of Subjects||95% Confidence Interval|Number
2801989|NCT00511914|Primary|Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Ratio||95% Confidence Interval|Geometric Mean
2801990|NCT00511914|Secondary|Number of Subjects Reporting Local and Systemic Reactions|To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.|3 days postvaccination|Analysis was done on safety set.|||Subjects|||Number
2801991|NCT00511914|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).|Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
2801992|NCT00511901|Secondary|POMS Depression-Dejection Scale|Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).|3,8,12 weeks|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a Scale||Inter-Quartile Range|Median
2801993|NCT00511901|Secondary|Activity Counts|Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Counts||Standard Deviation|Mean
2801994|NCT00511901|Secondary|FACIT Measurement System Fatigue Scale|Fatigue score ranges from 0 to 72. Lower score represents less fatigue|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a Scale||Standard Deviation|Mean
2801995|NCT00511901|Secondary|Short Physical Performance Battery (SPPB) Score|Measure physical function scored 0 - 12 (better)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a scale||Standard Deviation|Mean
2801996|NCT00511901|Secondary|Grip Strength|kilograms measured by hand held dynamometer|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||kg||Standard Deviation|Mean
2801997|NCT00511901|Secondary|Length of Stay in Subacute Rehabilitation Facility|Days from randomization to discharge|12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Days||Standard Deviation|Mean
2801998|NCT00511901|Secondary|Motor-FIM Score|FIM Motor score ranges from 13 to 91 (most independent)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up|||Scores on a Scale||Standard Deviation|Mean
2801999|NCT00511901|Primary|Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study||8 weeks following randomization|Intention to treat; of the subjects not lost to follow-up, 3 subjects in the placebo arm & 2 subjects in the epoetin alpha arm were not available for 8 week hemoglobin draw|||g/dL||Standard Deviation|Mean
2802000|NCT00511875|Secondary|Change in Arteriovenous Ratio Diameter|Change in arteriovenous ratio diameter from baseline|24 months||||ratio||Standard Deviation|Mean
2802001|NCT00511875|Secondary|Change in Central Retinal Vein Equivalent (CRVE) Diameter|Change in Central Retinal Vein Equivalent (CRVE) diameter from baseline|24 months||||μm||Standard Deviation|Mean
2802002|NCT00511875|Secondary|Change in Central Retinal Artery Equivalent (CRAE) Diameter|Change in Central Retinal Artery Equivalent (CRAE) diameter from baseline|24 months||||μm||Standard Deviation|Mean
2802003|NCT00511875|Secondary|Change in Macular Volume|Change in macular volume from baseline|24 months||||mm^3||Standard Deviation|Mean
2802004|NCT00511875|Secondary|Change in Central Subfield Thickness|Change in central subfield thickness from baseline|Baseline and 24 months||||μm||Standard Deviation|Mean
2802005|NCT00511875|Primary|Change in Early Treatment Diabetic Retinopathy Study (ETDRS)|Change in ETDRS visual acuity letter score from baseline. ETDRS is measured on a scale of 0 to 70 where 0 means inability to see anything on the chart and 70 is normal (20/20) acuity.|Baseline and 24 months||||score on a scale||Standard Deviation|Mean
2802006|NCT00511875|Primary|Change in Frequency Doubling Perimetry (FDP)|Change in Frequency Doubling Perimetry (FDP) from baseline, shown as mean and foveal (center of retina) scores|24 months||||dB||Standard Deviation|Mean
2802007|NCT00511875|Primary|Change in Photopic Visual Field|Change in photopic visual fields between baseline and 24 months|Baseline and 24 months||||dB||Standard Deviation|Mean
2802008|NCT00511875|Primary|Change in Dark Adaptation, Rod Intercept|Change in dark adaptation is measured as dark adaptation time at baseline measured in minutes minus dark adaptation time measured at 24 months|Baseline and 24 months|Of 10 participants who completed doxycycline treatment, usable endpoint data is only available for 8.|||minutes||Standard Deviation|Mean
2802009|NCT00511862|Post-Hoc|2 Year Survival|The percentage of patients in the neuroendocrine group alive at 2 years|24 months from treatment||||percentage of treated subjects|||Number
2802010|NCT00511862|Secondary|Overall Survival|Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.|Time from first TheraSphere treatment to death; median follow up 30 months|In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed in Outcome Measure 3.|||Months||95% Confidence Interval|Median
2802011|NCT00511862|Primary|Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)|Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.|From the date of first treatment until date of first documented progression; median patient follow-up 30 months|Patients receiving at least one TheraSphere treatment with images evaluable by RECIST|||Months||95% Confidence Interval|Median
2802012|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.|||Percentage (%) of Change||Standard Deviation|Mean
2802013|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.|||Percentage (%) of Change||Standard Deviation|Mean
2802014|NCT00511836|Secondary|Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data)|The Actiwatch-Score device (MiniMitter Co.) was used to collect data on daily alcohol craving. The Actiwatch device is a wrist-worn, battery-operated monitor programmed to beep every 3 hours ±20 minutes, to signal the subjects to enter their alcohol craving or desire to use alcohol at that exact moment on a scale of 0 to 10 units: 0 indicates no craving at all (best score) and 10 indicates extreme craving (worst score). A negative result for Change in Baseline at Day 28 indicates an improvement in daily craving as of 1 month after study drug administration.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had a craving score assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.|||Change in Daily Craving Score||Standard Deviation|Mean
2802015|NCT00511836|Secondary|Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects|There are 14 items on the Obsessive Compulsive Drinking Scale (OCDS). The scale is scored from 0 to 40 (units). A score of 0 units indicates no obsession-compulsion with respect to alcohol (best score). A score of 40 units indicates maximum obsession-compulsion with respect to alcohol (worst score). A negative Change from Baseline value indicates an improvement. For scoring methods, see: Anton RF, Moak DH, Latham P (1995), The Obsessive Compulsive Drinking Scale: A self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res 19:92-9.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had an Obsessive-Compulsive Drinking Scale (OCDS) assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.|||Change in OCDS score||Standard Deviation|Mean
2802016|NCT00511836|Primary|Change From Baseline in Blood Oxygen-level-dependent (BOLD) Signal Activation Values Detected in the Reward Circuitry of the Brain in Alcohol-dependent Subjects After Presentation of Alcohol-related Cues.|As was standard among fMRI studies conducted at the study site at the time, a change in BOLD signal in the range of 5% to 6% in anterior cingulate as measured using a 3T magnet,is considered highly significant in block-designed experiments.|14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.|||Percentage (%) of Change||Standard Deviation|Mean
2802017|NCT00511810|Primary|Mood Symptoms Ratings|Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.)|10 weeks||||CDRS-R score||Standard Deviation|Mean
2802018|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|The number of subjects without previous medication in DRSP 1 mg/EE 20 μg group was 1, so the standard deviation was not measurable. The number of subjects without previous medication in the other three groups were 0, so the data were not applicable.|||scores on a scale||Standard Deviation|Mean
2802019|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
2802020|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to Cycle 4 (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
2802021|NCT00511797|Post-Hoc|Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|From baseline to Cycle 4(28 days per cycle)|FAS (Participants with data at Cycle 4)|||scores on a scale||Standard Deviation|Mean
2802022|NCT00511797|Secondary|Change From Baseline in Serum Progesterone Level at Cycle 4|Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||ng/mL||Full Range|Mean
2802023|NCT00511797|Secondary|Change From Baseline in Serum Estradiol Level After 4-cycle Treatment|Estradiol is a predominant sex hormone that presents in female.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||pg/mL||Full Range|Mean
2802024|NCT00511797|Secondary|Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment|CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||mg/dL||Full Range|Mean
2802025|NCT00511797|Secondary|Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||Units/L||Full Range|Mean
2802026|NCT00511797|Secondary|Participants With Non-heavy Withdrawal Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 dyas per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802027|NCT00511797|Secondary|Participants With Non-heavy Intracyclic Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802028|NCT00511797|Secondary|Participants With Intracyclic Bleeding|Intracyclic bleedings were defined as bleedings while a participant takes active drugs.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802029|NCT00511797|Secondary|Participants With Withdrawal Bleeding|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802030|NCT00511797|Secondary|Number of Bleeding / Spotting Days|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)|||days||Standard Deviation|Mean
2802031|NCT00511797|Secondary|Number of Bleeding / Spotting Episodes|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)|||number of episodes||Standard Deviation|Mean
2802032|NCT00511797|Secondary|Change From Baseline in Endometrial Thickness After 4-cycle Treatment|Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||mm||Standard Deviation|Mean
2802033|NCT00511797|Secondary|Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||scores on a scale||Standard Deviation|Mean
2802034|NCT00511797|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||scores on a scale||Standard Deviation|Mean
2802035|NCT00511797|Secondary|Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802036|NCT00511797|Secondary|Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802037|NCT00511797|Secondary|Number of Participants With Severity of Headache During Menstruation at Cycle 4|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802038|NCT00511797|Secondary|Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4|Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802039|NCT00511797|Secondary|Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)|||participants|||Number
2802040|NCT00511797|Secondary|Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|Baseline and up to 4 Cycles (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
2802041|NCT00511797|Primary|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS|||scores on a scale||Standard Deviation|Mean
2802042|NCT00511706|Secondary|Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25.|Screening (-Week 28), Week 25|Participants from the intent-to-treat population (all randomized participants) with data available at Screening and Week 25 for analyses.|||Millimeters square (MM^2)||Standard Deviation|Mean
2802043|NCT00511706|Secondary|Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.|||Microns||Standard Deviation|Mean
2802044|NCT00511706|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.|||Letters||Standard Deviation|Mean
2802045|NCT00511706|Primary|Injection Free Interval|The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.|Week 1 to Week 25|Intent-to-treat population consisted of all randomized patients.|||Days||Inter-Quartile Range|Median
2802046|NCT00511667|Primary|Participants Discontinued Because of Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)||||participants|||Number
2802047|NCT00511667|Secondary|Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||nM||Standard Deviation|Mean
2802048|NCT00511667|Secondary|Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||hours||Standard Deviation|Mean
2802049|NCT00511667|Secondary|Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||hours||Full Range|Mean
2802050|NCT00511667|Secondary|Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||nM||Standard Deviation|Mean
2802051|NCT00511667|Secondary|Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)||||nM-hr||Standard Deviation|Mean
2802052|NCT00511667|Primary|Participants With Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)||||percentage of of participants|||Number
2802053|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period|During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.|Outpatient Days 1 to 14|All participants who experienced one or more adverse events during the Outpatient Treatment Period.|||participants|||Number
2802054|NCT00511472|Secondary|24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7|Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.|24 hours|All participants who had 24-hour weighted mean blood glucose levels evaluated on Day 7|||mg/dL||Standard Deviation|Least Squares Mean
2802055|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 2|Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 2|||participants|||Number
2802056|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 1|In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 1|||participants|||Number
2802057|NCT00511472|Primary|Number of Participants Who Experienced an Adverse Event During the Study||39 days|All participants who experienced one or more adverse events during the study|||participants|||Number
2802058|NCT00511433|Primary|Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||IU/L||Standard Deviation|Mean
2802059|NCT00511433|Secondary|Average Number of Withdrawal Bleeding Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."|||Days||Standard Deviation|Mean
2802060|NCT00511433|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||Days||Standard Deviation|Mean
2802061|NCT00511433|Primary|Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||International units per liter (IU/L)||Standard Deviation|Mean
2802062|NCT00511433|Primary|Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||picomoles per liter (pmol/L)||Standard Deviation|Mean
2802063|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Progesterone Value|The maximum progesterone value was defined as the largest value during a cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2802064|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Follicle Diameter|The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."|||millimeters (mm)||Standard Deviation|Mean
2802065|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation|During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.|Cycle 1, Cycle 2, and Cycle 6|"Intent-to-treat (ITT) group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."|||Participants|||Number
2802066|NCT00511433|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||Participants|||Number
2802067|NCT00511433|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
2802068|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802069|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802070|NCT00511433|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802089|NCT00511355|Primary|Serum Concentration of Corticosteroid Binding Globulin (CBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline to Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802090|NCT00511355|Primary|Serum Concentration of Total Cortisol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802071|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802072|NCT00511433|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or without sexual intercourse per diary card data)."|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
2802073|NCT00511433|Secondary|Effect on Maximum Endometrial Thickness|Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle."|||mm||Standard Deviation|Mean
2802074|NCT00511433|Secondary|Effect on Cervical Mucus as Determined by Insler Score|The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."|||score on a scale||Standard Deviation|Mean
2802075|NCT00511355|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had withdrawal bleeding/spotting for the respective cycle."|||Days||Standard Deviation|Mean
2802076|NCT00511355|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had breakthrough bleeding/spotting for the respective cycle."|||Days||Standard Error|Mean
2802077|NCT00511355|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||Participants|||Number
2802078|NCT00511355|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802091|NCT00511355|Primary|Serum Concentration of Hemoglobin Type A1c (HbA1c)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of glycosylated hemoglobin||Standard Deviation|Mean
2802079|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802080|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802081|NCT00511355|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802082|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."|||Participants|||Number
2802083|NCT00511355|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse per diary card data)."|||Pregnancies per 100 woman years|Woman years (rounded to nearest integer)|95% Confidence Interval|Number
2802084|NCT00511355|Secondary|Serum Concentration of Dihydrotestosterone (DHT)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802085|NCT00511355|Secondary|Serum Concentration of Androstenedione|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802086|NCT00511355|Primary|Serum Concentration of Thyroxin Binding Globulin (TBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mg/L||Standard Deviation|Mean
2802087|NCT00511355|Primary|Serum Concentration of Free Thyroxine (T4)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||pmol/L||Standard Deviation|Mean
2802088|NCT00511355|Primary|Serum Concentration of Thyroid Stimulating Hormone (TSH)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mU/L||Standard Deviation|Mean
2802092|NCT00511355|Primary|Incremental AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*pmol/L||Standard Deviation|Mean
2802093|NCT00511355|Primary|AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*pmol/L||Standard Deviation|Mean
2802094|NCT00511355|Primary|Incremental AUC3 for Glucose (OGTT)|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*mmol/L||Standard Deviation|Mean
2802095|NCT00511355|Primary|Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||hrs*mmol/L||Standard Deviation|Mean
2802096|NCT00511355|Primary|Serum Concentration of Total Triglycerides|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
2802097|NCT00511355|Primary|Serum Concentration of Lipoprotein(a)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||g/L||Standard Deviation|Mean
2802098|NCT00511355|Primary|Serum Concentration of Apolipoprotein B|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||g/L||Standard Deviation|Mean
2802099|NCT00511355|Primary|Serum Concentration of Apolipoprotein A-1|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||g/L||Standard Deviation|Mean
2802100|NCT00511355|Primary|Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
2802101|NCT00511355|Primary|Serum Concentration of HDL3-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
2802102|NCT00511355|Primary|Serum Concentration of HDL2-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
2802103|NCT00511355|Primary|Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
2802104|NCT00511355|Primary|Serum Concentration of Total Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mmol/L||Standard Deviation|Mean
2802105|NCT00511355|Primary|Serum Concentration of C-Reactive Protein (CRP)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mg/L||Standard Deviation|Mean
2802489|NCT00509093|Primary|Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment|Percent of participants 60 years of age or older with PFS at 8 and 13 months post-treatment|at 8 and 13 months after treatment.|All participants 60 years or older|||percent of participants|||Number
2802106|NCT00511355|Primary|Serum Concentration of Sex Hormone Binding Globulin (SHBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802107|NCT00511355|Primary|APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Ratio||Standard Deviation|Mean
2802108|NCT00511355|Primary|Serum Concentration of Protein C|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802109|NCT00511355|Primary|Serum Concentration of Protein S (Total)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802110|NCT00511355|Primary|Serum Concentration of Protein S (Free)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802111|NCT00511355|Primary|Serum Concentration of Antithrombin III|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802112|NCT00511355|Primary|Serum Concentration of Clotting Factor II|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802113|NCT00511355|Primary|Serum Concentration of Clotting Factor VIII|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802114|NCT00511355|Secondary|Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||umol/L||Standard Deviation|Mean
2802115|NCT00511355|Secondary|Serum Concentration of Free Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||pmol/L||Standard Deviation|Mean
2802116|NCT00511355|Secondary|Serum Concentration of Total Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802117|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIc|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Percent of normal||Standard Deviation|Mean
2802118|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIa|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||U/L||Standard Deviation|Mean
2802119|NCT00511355|Primary|Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||Ratio||Standard Deviation|Mean
2802120|NCT00511355|Primary|Serum Concentration of D-Dimer|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||mg/L Fibrinogen Equivalent Units (FEU)||Standard Deviation|Mean
2802121|NCT00511355|Primary|Serum Concentration of Prothrombin Fragments 1 + 2|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6|||nmol/L||Standard Deviation|Mean
2802122|NCT00511342|Secondary|Average Number of Withdrawal Bleeding-spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
2802123|NCT00511342|Secondary|Average Number of Breakthrough Bleeding-Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
2802124|NCT00511342|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
2802125|NCT00511342|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
2802126|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
2802127|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
2802138|NCT00511238|Secondary|Time to Progression (A0 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.|||months||95% Confidence Interval|Median
2802128|NCT00511342|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
2802129|NCT00511342|Primary|Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck|BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, & more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).|Baseline and after cycle 26 (2 years)|All-Subjects-Treated (AST) group consisted of all randomized participants who took at least one dose of trial medication. The number of participants in the AST group with a baseline value and a Week 26 value is presented.|||score on a scale||Standard Deviation|Mean
2802130|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."|||participants|||Number
2802131|NCT00511342|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|"Contraceptive efficacy parameter of this trial was the Pearl Index. In-treatment pregnancies were pregnancies with an estimated date of conception from~the day of first intake of trial medication up to and including the day of last(active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant."|2 years (26 cycles)|Restricted Intent-To-Treat (ITT) analysis set included all participants treated, and further excluded non-pregnant participants without at least one cycle expected to be at risk for pregnancy(with recorded use of condoms or without confirmed sexual intercourse, as determined from the electronic diary data).|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
2802132|NCT00511329|Secondary|Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover.||12 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
2802133|NCT00511329|Primary|The Primary Outcome Variables Will be Height and Weight Z Score.||12 months|PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.||||||
2802134|NCT00511238|Secondary|Overall Survival (A1 Only)|The time from start of treatment to death due to any cause OS was to be censored on the date the subject was last known to be alive for those who were alive or lost to follow-up as of a data analysis cutoff date.|Patients were to be followed by telephone contact for disease progression and OS every 3 months after study discontinuation for the first year and every 6 months thereafter for up to 2 years||||months||95% Confidence Interval|Number
2802135|NCT00511238|Secondary|Progression-free Survival (A1 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"|||months||95% Confidence Interval|Median
2802136|NCT00511238|Secondary|Progression-free Survival (A0 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.|||months||95% Confidence Interval|Median
2802137|NCT00511238|Secondary|Time to Progression (A1 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"|||months||95% Confidence Interval|Median
2802156|NCT00511147|Secondary|Duration of Response|Defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.|30 days|Number of participants analyzed is based on the number of responding patients (52/64 [81.3%]) in the Modified ITT Population|||days||Standard Deviation|Mean
2802139|NCT00511238|Secondary|Duration of Response (A1 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.|||months||95% Confidence Interval|Median
2802140|NCT00511238|Secondary|Duration of Response (A0 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.|||days||95% Confidence Interval|Median
2802141|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A1 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"|||participants|||Number
2802142|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A0 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.|||participants|||Number
2802143|NCT00511238|Primary|Best Overall Response Rate (ORR)|For both A0 and A1, to evaluate the best overall response rate (stringent complete response [sCR]+ complete response [CR]+ very good partial response [VGPR]+ partial response [PR]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therapy|A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.|Analysis population described in reporting groups below|||% of participants w/ PR or better||95% Confidence Interval|Number
2802144|NCT00511199|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
2802145|NCT00511199|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
2802146|NCT00511199|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||Participants|||Number
2802147|NCT00511199|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
2802698|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 48|The change from baseline in HBV DNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the Full Analysis Set with evaluable change data at Week 48 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
2802148|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of~the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
2802149|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||Participants|||Number
2802150|NCT00511199|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2802151|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2802152|NCT00511199|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).|||Pregnancies per 100 woman years|woman years (rounded to nearest integer)|95% Confidence Interval|Number
2802153|NCT00511199|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).|||Pregnancies per 100 woman years|woman years (rounded to nearest integer)|95% Confidence Interval|Number
2802154|NCT00511173|Primary|In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).|Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).|six months|power analysis based on data from Sconce, et al.|||mg/wk||Standard Deviation|Mean
2802155|NCT00511147|Secondary|Regression of Hemorrhage/Bleedings|Defined by the percentage of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1.|15 days|Number of participants analyzed is based on the number of patients with hemorrhage/bleeding at Day 1 in the Modified ITT Population|||percent of subjects with regression|||Number
2802491|NCT00509093|Primary|Progression-free Survival for Patients 60 Years of Age and Older|Progression free survival will be measured from the date of Complete Response (CR) to the date of relapse or death.|up to 5 years from the End of Treatment|All participants 60 years or older.|||months||Inter-Quartile Range|Median
2802157|NCT00511147|Secondary|Time to Platelet Count Recovery|Defined by the number of days elapsed from Day 1 (the day of the first infusion of the IP) to the day when the platelet count is first known to be ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1|30 days|Number of participants analyzed is based on the number of responding patients (52/64 [81.3%]) in the Modified ITT Population|||days||Standard Deviation|Mean
2802158|NCT00511147|Primary|Response Rate|Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L by Day 8 ± 1 [where the day of the first infusion is Day 1]|8 days|Modified ITT Population|||percentage of responders|||Number
2802159|NCT00511134|Secondary|Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level|Endpoint abstinence will be defined as 0 cigarettes over the seven days prior to the subject's Timeline Follow-Back evaluation at the end of week 7 (end of trial) and a Carbon Monoxide (CO) level ≤ 5.|6 weeks after target smoking quite date||||participants|||Number
2802160|NCT00511134|Primary|Level of Insomnia as Measured by the Insomnia Severity Index|Insomnia Severity Index (ISI): 13-item self-report measure which examines symptoms of insomnia, consequences of insomnia, and subjective distress related to sleep problems. Subjects rate the symptoms and consequences of insomnia on a 5 point Likert scales. For example, subjects are asked to rate the severity of their insomnia (e.g., difficulty falling asleep from 0=none to 4=very severe). Scores on the first 7 items are summed for a total insomnia score ranging from 0-28.|6 weeks after target smoking quit date|Baseline descriptive data was examined for the 4 participants. Outcome measures were available for 2 participants. Due to the small number of participants, statistical comparisons were not able to be performed.|||Units on a Scale||Full Range|Median
2802161|NCT00511108|Secondary|Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment|Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.|||mg*hr/dL||95% Confidence Interval|Least Squares Mean
2802162|NCT00511108|Primary|Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment|"Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state.~Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100."|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2802163|NCT00511108|Primary|Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment|Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.|||pg*hr/mL||95% Confidence Interval|Least Squares Mean
2802164|NCT00511095|Secondary|Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28|Measurement of Serum GMC|Weeks 4, 8, 12, and 28|"Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.~Note: Number Analyzed is the number of subjects with nonmissing concentrations at that visit."|||mIU/mL||95% Confidence Interval|Geometric Mean
2802165|NCT00511095|Secondary|Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.|Seroprotective Immune Response|Weeks 4, 8, 12 and 28|Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.|||percentage of subjects|||Number
2802166|NCT00511095|Primary|Percentage of Participants With Local and Systemic Post-injection Reaction Rates|Local and Systemic post-injection reactions.|Within 7 days post-injection for post-injection reactions at Week 0 and Week 4|Safety Population: Subjects who received at least 1 study injection and had any post-baseline safety data|||percentage of subjects|||Number
2802167|NCT00511004|Secondary|Brugia Specific Immunoglobulin G4 (IgG4) Antibodies|IgG4 antibodies directed against Brugia malayi antigen|2 years|By 2 years, 4 subjects in High Dose Group lost to followup|||ng/ml||Full Range|Median
2802168|NCT00511004|Secondary|Microfilarial Levels at 2 Years|Night time microfilarial levels at 2 years|2 years from time enrolled|By 2 years, 4 subjects in High Dose Group lost to followup|||MF/ML||Full Range|Median
2802169|NCT00511004|Secondary|Adult Worm Burdens at 2 Years|Doppler detected worm nests at 2 years|2 years from the time enrolled.|By 2 years, 4 subjects in High Dose Group lost to followup|||Number of nests||Full Range|Median
2802170|NCT00511004|Primary|Microfilarial Counts at 1 Year|Night time microfilarial counts at 1 year|1 year from time enrolled||||MF/ML||Full Range|Median
2802171|NCT00510952|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||Units of insulin/kilograms (U/kg)||Standard Deviation|Mean
2802172|NCT00510952|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||Units of insulin||Standard Deviation|Mean
2802173|NCT00510952|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||kilograms (kg)||Standard Deviation|Mean
2802174|NCT00510952|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||hypoglycemic events per 30 days||Standard Deviation|Mean
2802175|NCT00510952|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||hypoglycemic event per 1 year||Standard Deviation|Mean
2802176|NCT00510952|Secondary|Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||participants|||Number
2802177|NCT00510952|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint|Actual measurements and daily mean blood glucose levels at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2802178|NCT00510952|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2802179|NCT00510952|Secondary|Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||percentage of participants|||Number
2802180|NCT00510952|Secondary|Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.|||percent hemoglobin||Standard Error|Least Squares Mean
2802181|NCT00510952|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.|||percent of HbA1c||Standard Error|Least Squares Mean
2802182|NCT00510887|Secondary|Number of Participants With Neuropathy, Any Grade|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year||||participants|||Number
2802183|NCT00510887|Secondary|Number of Participants With a Grade 3-4 Hematologic Toxicity.|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year||||participants|||Number
2802184|NCT00510887|Secondary|Percentage of Subjects Experiencing Overall Survival|Overall survival is from the day of enrollment to date of death from any cause.|up to 2 years||||percentage of participants|||Number
2802185|NCT00510887|Secondary|Percentage of Subjects Experiencing Progression Free Survival|Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.|up to 2 years||||percentage of participants|||Number
2802186|NCT00510887|Secondary|Duration of Response|Duration of response is measured from time of treatment to time of disease progression|up to 4 years||||months||Full Range|Mean
2802187|NCT00510887|Primary|Complete and Partial Response|"Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma.~Partial Response requires the following:~greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses.~No increase in size of other nodes, liver, or spleen.~Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD).~Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported.~No new lesions."|1 year||||percentage of participants|||Number
2802243|NCT00510458|Secondary|Percentage of Cases That Did Not Have Any Component Revised|"A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner.~The 97.42% estimate is obtained by Kaplan-Meier method."|5 years|Participants/hips with available data.|||percentage of hips|hips||Number
2802188|NCT00510874|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.|At Days 0, 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
2802189|NCT00510874|Secondary|Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
2802190|NCT00510874|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
2802191|NCT00510874|Secondary|Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 21 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
2802192|NCT00510874|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
2802193|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Between Day 0 and Day 84 after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
2802194|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day follow-up period (Days 0-20) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
2802195|NCT00510874|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
2802196|NCT00510874|Primary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
2802197|NCT00510874|Primary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Participants|||Count of Participants
2802198|NCT00510874|Primary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
2802297|NCT00510224|Secondary|Grade 4-5 Adverse Events||12 weeks||||Adverse Events|||Number
2802199|NCT00510874|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
2802200|NCT00510874|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.|||Participants|||Count of Participants
2802201|NCT00510835|Secondary|Resource Use and Costs of Alternative Resuscitation Strategies||at discharge or 60 days, whichever comes first|||||||
2802202|NCT00510835|Secondary|Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.||study hour 0, 6, 24 & 72|||||||
2802203|NCT00510835|Primary|Hospital Mortality|The primary study outcome is hospital mortality (defined as the number of deaths prior to discharge or 60 days, whichever comes first). The secondary outcomes are duration of survival (90 day and 1 year) and clinical evidence of organ dysfunction.|prior to discharge or 60 days, whichever comes first||||Participants|||Count of Participants
2802204|NCT00510809|Secondary|Adverse Events Reported|All events reported that were deemed to be related, or unrelated, to the study drug.|Week 8||||number of events reported|||Number
2802205|NCT00510809|Primary|Lipid Profile||Change between Week 8 and Baseline||||mg/dl||Standard Error|Mean
2802206|NCT00510783|Primary|Number of Participants Who Experienced a Recurrent Seizure After Treatment.|Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.|24 hours||||participants|||Number
2802207|NCT00510744|Primary|Fat Absorption|72 hour fat absorption study|3 months|each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption|||g/d||Standard Error|Mean
2802208|NCT00510718|Other Pre-specified|Percentage of Participants With Prostate Specific Antigen (PSA) Response at Day 84: Multiple Dose Period|Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from baseline to the PSA level at Day 84 was considered as a PSA response.|Baseline, Day 84|Analysis population included all enrolled participants who received at least 1 dose of study drug. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2802209|NCT00510718|Secondary|Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period|Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||liters per hour||Standard Deviation|Mean
2802210|NCT00510718|Secondary|Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period||Pre-dose on Day 1 of Multiple Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||microgram per milliliter||Standard Deviation|Mean
2802211|NCT00510718|Secondary|Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period||Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2802212|NCT00510718|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period||Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2802213|NCT00510718|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period||Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||microgram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2802214|NCT00510718|Secondary|Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period|Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2802298|NCT00510224|Secondary|Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.|Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).|Baseline, 12 weeks||||percent change||Full Range|Median
2802215|NCT00510718|Secondary|Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period|Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||liters||Geometric Coefficient of Variation|Geometric Mean
2802216|NCT00510718|Secondary|Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period|T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2802217|NCT00510718|Secondary|Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period||Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.|||microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2802218|NCT00510718|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period||Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.|||hours||Full Range|Median
2802219|NCT00510718|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period||Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||microgram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2802220|NCT00510718|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period||Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period|PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||microgram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2802221|NCT00510718|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period||Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period|Pharmacokinetic (PK) evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, “Overall Number of Participants Analyzed” signifies participants who were evaluable for this outcome measure.|||microgram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2802222|NCT00510718|Primary|Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period|Tolerability was defined as if less than (<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and < 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if <8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.|Baseline up to first 35 days of the study treatment in multiple dose period|Safety population included all enrolled participants who received at least 1 dose of study drug.|||milligrams per day|||Number
2802223|NCT00510718|Primary|Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period|DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.|Baseline up to first 35 days of the study treatment in multiple dose period|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2802224|NCT00510718|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)|An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2802225|NCT00510692|Secondary|Number of Subjects With Adverse Events.|Incidence of adverse events in each treatment group.|6 months compared to baseline||||participants|||Number
2802226|NCT00510692|Secondary|Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.|Relative EPA concentration of total free fatty acids in the rectal mucosa of subjects with FAP.|6 months compared to baseline.|3 subjects in the full analysis set had no samples for analysis.|||percentage of total fatty acid content||95% Confidence Interval|Mean
2802242|NCT00510484|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
2802227|NCT00510692|Secondary|Change in Global Rectal Polyp Burden.|"Change in global rectal polyp burden in subjects treated with Eicosapentanoic Acid (EPA) compared to subjects receiving placebo. Each reviewer in the Polyp Video Scoring Committee assessed global colorectal polyp burden change as better, same as or worse. The qualitative assessment was assigned a score of +1 for better, 0 for same as and -1 for worse. Thereafter a mean overall reviewers score was calculated."|6 months compared to baseline.|5 subjects in the full analysis set lacked the video required for determining global rectal polyp burden due to failure of equipment.|||units on a scale||95% Confidence Interval|Mean
2802228|NCT00510692|Secondary|Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.|Percentage change in the number of polyps measured in the defined focal area of the rectum in subjects treated with EPA compared to subjects receiving placebo.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.|||percentage of change in total polyps||95% Confidence Interval|Mean
2802229|NCT00510692|Primary|Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.|Absolute change in the number of polyps measured in a defined focal area of the rectum.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.|||Change from baseline number of polyps.||Standard Deviation|Mean
2802230|NCT00510653|Primary|Overall Response Rate (ORR)|ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): >/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or > increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.|6 weeks with re-evaluation every 6 weeks or until disease progression|Two participants were not evaluable for response: in 1 participant, early toxicity caused discontinuation of the drug, and the other patient had an intestinal obstruction requiring palliative surgery after 1 day of therapy.|||participants|||Number
2802231|NCT00510510|Secondary|Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day|Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.|28 Days||||Liters||Standard Error|Least Squares Mean
2802232|NCT00510510|Primary|Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)|The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.|28 days||||Participants|||Number
2802233|NCT00510497|Secondary|Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)|Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption|at the end of 12 weeks treatment interruption||||log10 HIV RNA||Full Range|Median
2802234|NCT00510497|Primary|Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.|AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004|80 weeks||||participants with Grade 3 events related|||Number
2802235|NCT00510484|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
2802236|NCT00510484|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
2802237|NCT00510484|Other Pre-specified|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage of days||Standard Deviation|Mean
2802238|NCT00510484|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Number per day||Standard Deviation|Mean
2802239|NCT00510484|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
2802240|NCT00510484|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Grams||Standard Deviation|Mean
2802241|NCT00510484|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.|||Percentage||Standard Deviation|Mean
2802244|NCT00510458|Secondary|Number of Hips Evaluated as Radiographically Unstable|"Radiographic instability is defined as having any of the following findings on x-ray:~Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component~Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component~Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component~Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm."|1, 3, 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 1 year population.|||hips|hips||Count of Units
2802245|NCT00510458|Secondary|Number of Hips That Dislocated|The number of hips that experienced a hip dislocation.|3 and 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 3 year population.|||hips|hips||Count of Units
2802246|NCT00510458|Secondary|Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative|The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|preoperative, 1, 3, and 5 Years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2802247|NCT00510458|Secondary|Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.|The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|preop, 1, 3, and 5 Years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2802248|NCT00510458|Secondary|Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.|"This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome.~Flexion:~0-45 degrees x 1.0 index value = max 45 points~45-90 degrees x 0.6 index = max 27 points~90-110 degrees x 0.3 index = max 6 points~110-130 degrees = max 0 points~Abduction:~0-15 degrees x 0.8 index = max 12 points~15-20 degrees x 0.3 index = max 1.5 points~20-45 degrees x 0 index = max 0 points~External Rotation in extension:~0-15 degrees x 0.4 index = max 6 points~Over 15 degrees = max 0 points~Internal Rotation in extension:~Any = max 0 points~Adduction:~0-15 degrees x 0.2 index = max 3 points~Over 15 degrees - max 0 points~To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05."|preoperative, 1, 3, and 5 Years|"Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.~Cases at 1 and 5 years all had a score of 5, therefore there is zero standard deviation."|||units on a scale|hip|Standard Deviation|Mean
2802249|NCT00510458|Secondary|Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits|"This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it.~Pain:~None or ignores it = 44 points~Slight, occasional, no compromise in activities = 40 points~Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points~Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points~Marked pain, serious limitation of activities = 10 points~Totally disabled, crippled, pain in bed, bedridden = 0 points"|preop, 1, 3, and 5 Years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2802250|NCT00510458|Secondary|Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits|"The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor.~90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor"|preoperative, 1, 3, and 5 years|Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.|||units on a scale|hips|Standard Deviation|Mean
2802251|NCT00510458|Primary|Linear Wear Rate|"Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period.~."|5 Years Post-Surgery|Participants/hips with available data.|||mm/year|hips|Standard Deviation|Mean
2802252|NCT00510289|Secondary|Change in Microvessel Density|Microvessel density will be measured before and after treatment, and the distribution of change across time will be summarized with descriptive statistics.|Measured before and after treatment|This outcome was not analysed due to the early closure of the study.||||||
2802253|NCT00510289|Secondary|Overall Survival|Overall Survival is defined as the number of months from enrollment onto the study until death from any cause in subjects who took study drug for at least cycle 1.|1 year from the last dose of study drug|7 subjects completed cycle 1 or beyond.|||months||Full Range|Mean
2802254|NCT00510289|Secondary|Time to Progression|Time to progression will be defined as the number of months between on-study and the date of progression or death, whichever comes first, in subjects who took study drug for at least cycle 1.|5 years|7 patients completed cycle one and had bone marrow biopsies to confirm response.|||months||Full Range|Median
2802255|NCT00510289|Secondary|Number of Subjects Requiring Dose Reductions|The number of subjects who took study drug for more than 1 cycle and required a dose reduction down to the next dose level.|While on study drug, a maximum of 5 years|7 Subjects completed beyond cycle 1. 4 of those subjects had dose reductions during the time they took study drug.|||participants|||Number
2802510|NCT00509028|Secondary|Number of Patients With Abnormal Plasma Cortisol Values.|Cut-off value of cortisol is defined as 4 mcg/dL.|54 weeks||||Participants|||Number
2802256|NCT00510289|Primary|Number of Subjects Achieving Hematological Response|Hematological response is defined as the number of subjects who achieve either a complete response (CR), Partial response (PR) or Hematologic improvement.(HI). HI is defined as peripheral blood counts with hemoglobin ≥11 g/dL, absolute neutrophil count ≥1x10(9)/L and platelet count ≥100x10(9)/L, and normal bone marrow morphology with no evidence of dysplasia or blasts. CR is defined as the disappearance of all signs and symptoms related to disease, along with HI. PR is defined as fulfilling the criteria for CR in the peripheral blood but blasts decreasing by 50% or more in the bone marrow or to a less advanced WHO classification pretreatment.|During treatment - up to a maximum of 5 years|There were 16 subjects enrolled in the trial. 9 subjects refused further bone marrow biopsy to assess response to therapy. Therefore, there were 7 evaluable subjects. One subject experienced PR|||participants|||Number
2802257|NCT00510276|Secondary|Strong Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||participants|||Number
2802258|NCT00510276|Secondary|Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||participants|||Number
2802259|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)|Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802260|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section|The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802261|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section|The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802262|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section|The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802263|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section|The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802264|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section|The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802265|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section|The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802266|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section|The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802267|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section|BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802268|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section|The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802269|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section|The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802270|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section|Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802299|NCT00510224|Primary|PSA Response|Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.|12 weeks|n=27 was determined to be sufficient to test for a 20% PSA response proportion compared with a null hypothesis of 5%. A two-stage design was employed to carry out an interim analysis for efficacy. As no patient showed a PSA decline among the first 13 accrued after 3 cycles (the first evaluation of PSA response), accrual was discontinued|||Participants|||Number
2802271|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section|The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802272|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score|The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802273|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score|The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802274|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score|The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802275|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report|26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802276|NCT00510276|Primary|Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint|CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, Week 12|Intent-to-treat population was analyzed, including all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802277|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report|26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802278|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)|Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60.|Baseline, 12 weeks|Analyzed was a intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802300|NCT00510198|Secondary|Cardiovascular Hospitalizations|To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm|up to five years|The study was stopped early, therefore secondary objectives were not able to be analyzed.||||||
2802279|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)|The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802280|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of joints per day||Standard Error|Least Squares Mean
2802281|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of nicotine products per day||Standard Error|Least Squares Mean
2802282|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||ratio||Standard Deviation|Mean
2802283|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of caffeinated drinks per day||Standard Error|Least Squares Mean
2802284|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||number of alcoholic drinks per day||Standard Error|Least Squares Mean
2802285|NCT00510276|Secondary|Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score|"AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.~CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores."|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||correlation coefficient|||Number
2802286|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)|21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802511|NCT00509028|Secondary|Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator||54 weeks||||Participants|||Number
2802287|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)|Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802288|NCT00510276|Secondary|Endpoint Scores in Patient Global Impression - Improvement (PGI-I)|7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802289|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score|30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, 12 weeks|An intent-to-treat population was analyzed using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802290|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)|Single-item clinician rating of the clinician's assessment of the patient's severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802291|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802292|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802293|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802294|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Intent-to-treat population was used for analysis. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802295|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Analyzed was an intent-to-treat population. Included were all randomized patients who had both a baseline and at least 1 post baseline score.|||units on a scale||Standard Error|Least Squares Mean
2802296|NCT00510224|Secondary|Pre Versus Post Treatment Mitogenic Effects.||12 Weeks|The trial was closed for futility after no PSA responses were observed among the first 13 patients, and this analysis was not performed||||||
2802302|NCT00510198|Primary|Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm|A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death|Up to five years|all randomized subjects; intention to treat|||Number of Participants with a Event|||Number
2802303|NCT00510198|Primary|Number of Participants With Heart-Failure Hospitalization or All-Cause Death|"A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring (Access Arm) compared to HF subjects managed with standard clinical assessment alone (Control Arm)"|Up to five years|all randomized subjects; intention to treat|||Participants with an Event|||Number
2802304|NCT00510146|Secondary|Number of Participants With Adverse Events (Open-Label Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.|||participants|||Number
2802305|NCT00510146|Secondary|Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|Endpoint (Week 24)|Total participants in the open-label extension phase.|||percentage of participants|||Number
2802306|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||beats per minute||Standard Deviation|Mean
2802307|NCT00510146|Secondary|Change From Baseline to Endpoint in ECG (Open-Label Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||milliseconds||Standard Deviation|Mean
2802308|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimole/Liter||Standard Deviation|Mean
2802309|NCT00510146|Secondary|Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||micromole/Liter||Standard Deviation|Mean
2802310|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||microgram/Liter||Standard Deviation|Mean
2802311|NCT00510146|Secondary|Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||billion cells per liter (BILL/L)||Standard Deviation|Mean
2802312|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimole/Liter of iron (Fe)||Standard Deviation|Mean
2802313|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||trillion cells per liter (Tril/L)||Standard Deviation|Mean
2802314|NCT00510146|Secondary|Change From Baseline to Endpoint in Creatinine (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||micromole/Liter||Standard Deviation|Mean
2802315|NCT00510146|Secondary|Change From Baseline to Endpoint in Chloride (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimole/Liter||Standard Deviation|Mean
2802316|NCT00510146|Secondary|Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||units/Liter||Standard Deviation|Mean
2802317|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||gram/Liter||Standard Deviation|Mean
2802318|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Open-Label Phase)||Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||kilograms||Standard Deviation|Mean
2807000|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
2802319|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||millimeters of mercury||Standard Deviation|Mean
2802320|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 24)|Participants who entered Open-Label Phase with a normal baseline and at least one post-baseline result.|||percentage of participants|||Number
2802321|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.|||percentage of participants|||Number
2802322|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2802323|NCT00510146|Secondary|Percentage of Participants With Recovery (Open-Label Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.|||percentage of participants|||Number
2802324|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.|||percentage of participants|||Number
2802325|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.|||percentage of participants|||Number
2802326|NCT00510146|Secondary|Number of Participants With Adverse Events (Acute Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline through Week 6 (Acute Phase)|All enrolled participants in Acute Phase|||participants|||Number
2802327|NCT00510146|Secondary|Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors.|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2802328|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||beats per minute (bpm)||Standard Deviation|Mean
2802329|NCT00510146|Secondary|Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||milliseconds||Standard Deviation|Mean
2802330|NCT00510146|Secondary|Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||ratio||Standard Deviation|Mean
2802331|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||microgram/Liter||Standard Deviation|Mean
2802332|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||millimole/Liter of iron (Fe)||Standard Deviation|Mean
2802334|NCT00510146|Secondary|Change From Baseline to Endpoint in Hematocrit (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||proportion of blood volume||Standard Deviation|Mean
2802335|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||trillion cells per liter ( TRIL/L)||Standard Deviation|Mean
2802336|NCT00510146|Secondary|Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||micromole/Liter||Standard Deviation|Mean
2802337|NCT00510146|Secondary|Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units/Liter||Standard Deviation|Mean
2802338|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||gram/Liter||Standard Deviation|Mean
2802339|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||millimole/Liter||Standard Deviation|Mean
2802340|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||kilograms||Standard Deviation|Mean
2802341|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||mmHg (millimeters of mercury)||Standard Deviation|Mean
2802342|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 6)|Participants with a normal baseline and an endpoint result.|||percentage of participants|||Number
2802343|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Acute Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population|||percentage of participants|||Number
2802344|NCT00510146|Secondary|Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)|In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2802345|NCT00510146|Secondary|Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)|In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2802346|NCT00510146|Secondary|Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)|In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2802347|NCT00510146|Secondary|Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)|In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2802348|NCT00510146|Secondary|Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)|In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
2802349|NCT00510146|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2802350|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2802351|NCT00510146|Secondary|Percentage of Participants With Recovery (Acute Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6 )|Intention-to-treat (ITT) population; all randomized participants.|||percentage of participants|||Number
2802352|NCT00510146|Secondary|Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2802353|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.|||percentage of participants|||Number
2802354|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)|Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.|||percentage of participants|||Number
2802355|NCT00510146|Primary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
2802356|NCT00510068|Secondary|Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
2802357|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
2802358|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
2802359|NCT00510068|Secondary|Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
2802360|NCT00510068|Secondary|Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.|||pg/mL||Standard Deviation|Mean
2802361|NCT00510068|Secondary|Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier|Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO >= 2, or from a baseline value of 2 to WHO >= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to do light work; Grade 2: Ambulatory & capable of all self-care but unable to carry out any work. Up & about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled & cannot carry on any self-care; totally confined to bed or chair.|3 months, 6 months|The Full Analysis Set (FAS) consists of all patients who were randomized.|||% of participants with no deterioration|||Number
2802362|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. Values for tmax where summarized in median (range).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||h||Full Range|Median
2802363|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: CL/F|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||L/h||Standard Deviation|Mean
2802364|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||ng/mL||Standard Deviation|Mean
2802365|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.|||ng.h/mL||Standard Deviation|Mean
2802366|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation|The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.|||Participants|||Number
2802367|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation|The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2802368|NCT00510068|Secondary|Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response|"Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.|||Months||95% Confidence Interval|Median
2802369|NCT00510068|Secondary|Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response|"Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An 'early response' (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.|||Months||95% Confidence Interval|Median
2802386|NCT00509925|Secondary|Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)|Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
2807057|NCT00471497|Secondary|Rate Reduction in BCR-ABL Transcript Levels in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months|||||||
2802370|NCT00510068|Secondary|Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%|The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, > 2% to less than or equal to 5% and > 5%.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.|||Months||95% Confidence Interval|Median
2802371|NCT00510068|Secondary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.|Baseline, to death- no time limit|The Full Analysis Set (FAS) included all randomized patients.|||Months||95% Confidence Interval|Median
2802372|NCT00510068|Secondary|Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})|Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.|||Percentage of participants||95% Confidence Interval|Number
2802373|NCT00510068|Primary|Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology|Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.|||Months||95% Confidence Interval|Median
2802374|NCT00509925|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.|||episodes|||Number
2802375|NCT00509925|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.|||episodes|||Number
2802376|NCT00509925|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (FPG) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||mmol/L||Standard Deviation|Mean
2802377|NCT00509925|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||percentage of total haemoglobin||Standard Deviation|Mean
2802378|NCT00509925|Secondary|Hormonal Assessment: Leptin|Leptin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
2802379|NCT00509925|Secondary|Hormonal Assessment: Resistin|Resistin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
2802380|NCT00509925|Secondary|Hormonal Assessment: Insulin-like Growth Factor-1|Insulin-like growth factor-1 (IGF-1) levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
2802381|NCT00509925|Secondary|Hormonal Assessment: Adiponectin|Adiponectin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||ng/ml||Standard Deviation|Mean
2802382|NCT00509925|Secondary|Waist:Hip Ratio|At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||percentage of hip circumference||Standard Deviation|Mean
2802383|NCT00509925|Secondary|Fat Mass|Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kg||Standard Deviation|Mean
2802384|NCT00509925|Secondary|Lean Body Mass|Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kg||Standard Deviation|Mean
2802387|NCT00509925|Secondary|Component of Total Energy Expenditure: Physical Activity Thermogenesis|Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32).|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
2802388|NCT00509925|Primary|Total Energy Expenditure, Dietary Record Method|The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
2802389|NCT00509925|Secondary|Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)|Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual's average daily food intake.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
2802390|NCT00509925|Secondary|Component of Total Energy Expenditure: Resting Energy Expenditure (REE)|Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
2802391|NCT00509925|Primary|Total Energy Expenditure, Double-labelled Water Method|Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.|||kcal/day||Standard Deviation|Mean
2802392|NCT00509899|Secondary|Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG performance status measures patients' functional status on the following scale:~0=Fully active, no restrictions;~1=Restricted in physically strenuous activity but ambulatory, able to carry out light work;~2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about > 50% of waking hours;~3=Limited selfcare, confined to bed or chair more than 50% of waking hours;~4=Completely disabled. Totally confined to bed or chair;~5=Dead.~Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1."|Baseline and Week 24|Intent-to-treat population for patients who had reached each time point and for whom data was available.|||participants|||Number
2802393|NCT00509899|Secondary|Change From Baseline in Body Weight Over Time||Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.|Intent-to-treat population for patients who had reached each time point and for whom data was available.|||kg||Standard Deviation|Mean
2802394|NCT00509899|Secondary|Change From Baseline to Week 24 in Health-Related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 24|The safety population included all subjects who received at least 1 dose of study medication, and for whom data was available at both time points. The EORTC QLQ C30 was implemented by protocol amendment and as a result this data are available for only approximately 50% of the enrolled patients.|||units on a scale||Standard Deviation|Mean
2802395|NCT00509899|Secondary|Change From Baseline in Myelofibrosis Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population for whom data was available. The MFSAF was implemented by protocol amendment while the study was ongoing. Hence data are available for only approximately 50% of enrolled patients. This analysis includes patients with a Baseline total symptom score ≥ 0; 8 patients were excluded because they had a Baseline score = 0.|||scores on a scale||Standard Deviation|Mean
2802423|NCT00509665|Secondary|Overall Survival||From the time of initial therapy until the time of death.||||Months||95% Confidence Interval|Median
2802424|NCT00509665|Secondary|Progression-free Survival||Through the end of follow up, for an average of 8 months|Only patients who had re-staging scans are included in the number of participants analyzed.|||months||95% Confidence Interval|Median
2802425|NCT00509665|Secondary|Duration of Response||Every 6 weeks for up to 8 months|data for this endpoint was not collected||||||
2807058|NCT00471497|Secondary|Rate of Durable MMR at 24 Months.||Baseline, 24 months|||||||
2802396|NCT00509899|Secondary|Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time|"Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques.~For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume."|Baseline, Weeks 4, 12, 24 and 48|Patients with at least 1 Spleen-Volume Measurement. Patients who had not reached the visit were excluded from the analysis. In addition, at Week 48, 5 patients who did not have MRI measurement due to a protocol amendment were considered as not evaluable and were excluded from the analysis.|||percentage of participants|||Number
2802397|NCT00509899|Secondary|Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time|For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length.|Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60|Intent to treat population. A total of 16 patients had either a splenectomy prior to study entry, missing Baseline spleen values or had spleen lengths reported as 0 cm and were excluded.|||percentage of participants|||Number
2802398|NCT00509899|Primary|Percentage of Participants With Clinical Improvement (CI) Over Time|"Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following:~A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent;~Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at > 5 cm at Baseline becomes not palpable;~A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10^9/L or~A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10^9/L."|Week 12, 24, 36, 48 and 60|The intent-to-treat population included all patients who received at least 1 dose of study medication and had at least 1 follow-up assessment for safety and efficacy. N = the number of patients who had clinical response assessed during the time interval.|||percentage of participants|||Number
2802399|NCT00509899|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline.~Treatment-Related AEs are those with a definite, probable, possible or missing causality.~A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above.~A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0."|From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.|Safety population included all patients who received at least 1 dose of study medication.|||participants|||Number
2802400|NCT00509873|Post-Hoc|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|"Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|||Percentage of Patients|||Number
2802401|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6|Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
2802402|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6|Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
2802403|NCT00509873|Secondary|Percentage of Patients With Microbiological Cure at Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
2802447|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below tx segment"|1 Week post treatment (no baseline)|Data available at 1-week follow-up visit|||limbs|limbs||Number
2802404|NCT00509873|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."|||Percentage of Patients|||Number
2802405|NCT00509821|Secondary|Change in Neurologic Status as Measured by Mini Mental Status Questionnaire, Total Score|Mini Mental State Status questionnaire is 11 questions, total score can range from 0 to 30, with a higher score indicating better function and a negative change in baseline indicating decrease in cognitive function.|Baseline through Week 12 .|All participants in BID arm who received at least 1 dose of study drug and had evaluable data. Enzastaurin QD participants data not collected, as per protocol.|||units on a scale||Standard Deviation|Mean
2802406|NCT00509821|Secondary|Response Rate|Response rate is calculated as the number of participants with best response: complete response(CR: disappearance of all enhancing tumor on consecutive CT or magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved ) or partial response (PR:-50% reduction in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved), divided by the number of participants treated, multiplied by 100. CR and PR were assessed according to the criteria defined by MacDonald et al. 1990. A CR or PR must be confirmed by a second assessment, performed ≥28 days after the first evidence of response.|Baseline to 30 months|All participants in BID arm who received at least 1 dose of study drug. Enzastaurin QD participants data not collected, as per protocol.|||percentage of participants||95% Confidence Interval|Number
2802407|NCT00509821|Secondary|Percentage of Participants With Overall Survival at 1 and 2 Years After Surgery|Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date. OS rate at 1 year (respectively 2 years) is determined using the OS times.|Baseline to 1 and 2 year|All participants in BID arm who received at least one dose of study drug, BID, 11 participants were censored. Enzastaurin QD participants data not collected, as per protocol.|||percentage of participants||95% Confidence Interval|Number
2802408|NCT00509821|Primary|Percentage of Participants With Progression Free Survival at 6 Months (PFS-6)|PFS-6 is defined as the percentage of participants with PFS at 6 months from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.Estimation using Kaplan-Meier technique.|Baseline to 6 months|All participants in BID arm who received at least one dose of study drug, BID, 4 participants were censored. Enzastaurin QD participants data not collected, as per protocol.|||percentage of participants||95% Confidence Interval|Number
2802409|NCT00509795|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)|CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.|Baseline and at week 52|FAS population used for analysis.|||mm^2||Standard Deviation|Mean
2802410|NCT00509795|Secondary|Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 52|FAS population used for analysis.|||scores on a scale||Standard Deviation|Mean
2802411|NCT00509795|Secondary|Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.|||percentage of patients|||Number
2802412|NCT00509795|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.|||letters read||Standard Deviation|Mean
2802413|NCT00509795|Primary|Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)|"Defined maintenance of vision as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline."|Baseline and at week 52|PPS population used for analysis.|||percentage of patients|||Number
2802414|NCT00509769|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
2802448|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below treated (tx) segment"|48 Hours post treatment (no baseline)|Data available at 48hrs follow-up visit|||limbs|limbs||Number
2802415|NCT00509769|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
2802416|NCT00509769|Secondary|Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Percentage of patients||95% Confidence Interval|Number
2802417|NCT00509769|Secondary|Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
2802418|NCT00509769|Secondary|Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Months||95% Confidence Interval|Median
2802419|NCT00509769|Primary|Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.|||Percentage of patients||95% Confidence Interval|Number
2802420|NCT00509665|Secondary|Correlation of Cytotoxicity With Apoptosis in Cancer Cells||prior to first dose of drug and every 6 weeks for up to 6 months|Data for this endpoint was not collected||||||
2802421|NCT00509665|Secondary|Correlation of Cytoxocity With Cell-cycle Arrest||prior to first dose of drug and every 6 weeks up to 6 months|data for this endpoint was not collected||||||
2802422|NCT00509665|Secondary|Number of Patients Who Had Greater Than Grade 2 Toxicity||from time of initial treatment until end of study, an average of 6 months|Patients who were treated on study and had greater than grade 2 toxicity.|||Participants|||Count of Participants
2802426|NCT00509665|Primary|Response Rate|Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.|Every 6 weeks from the time of initial treatment for up to 8 months|patients who were on study at the time of response assessment|||participants|||Number
2802427|NCT00509600|Primary|Patient Response|Response is defined as a WBC < 15,000 and platelets > 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.|12 weeks|No analysis as only registrant inevaluable, and trial terminated early due to poor enrollment.||||||
2802428|NCT00509587|Secondary|Adverse Events Graded According to the NCI CTCAE Version 3.0|grade 3- 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).|Up to 3 years||||percentage of patients|||Number
2802429|NCT00509587|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Up to 3 years||||months||95% Confidence Interval|Median
2802430|NCT00509587|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions|6 months||||percentage of patients||95% Confidence Interval|Number
2802431|NCT00509587|Secondary|Duration of Stable Disease||From the start of the treatment until the criteria for progression are met, assessed up to 3 years||||months||95% Confidence Interval|Median
2802432|NCT00509587|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|Duration of objective response was not analyzed for 1 patient who achieved PR||||||
2802433|NCT00509587|Primary|Number of Participants With Partial and Complete Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years||||participant|||Number
2802434|NCT00509496|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years||||Participants|||Number
2802435|NCT00509496|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|20 months||||Participants|||Number
2802436|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|1 Month|Data at 1 month follow-up visit|||units on a scale|limbs|Standard Deviation|Mean
2802437|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|2 Week|Data at 2-week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802438|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|1 Week|Data at one week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802439|NCT00509392|Secondary|Change in CIVIQ QOL|"Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).~Global index and an outline of 4 quality-of-life dimensions: pain (4 items), physical (4 items), psychological (9 items), and social (3 items). A low global (total) score corresponds to greater patient comfort.~Change from Baseline"|48 Hours|Data at 48 hrs follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802440|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|1 Month|Data at 1- month follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802441|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|2 Weeks|Data at 2 week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802442|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|1 Week|Data at 1-week follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802443|NCT00509392|Secondary|VCSS|"Venous Clinical Severity Score (0-30 total overall score):~0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease"|48 Hours|Data at 48 hours for follow up visit|||units on a scale|limbs|Standard Deviation|Mean
2802444|NCT00509392|Primary|Complications|Sequelae at any follow-up|1 month|Data up to one month follow up visit|||limbs|limbs||Count of Units
2802445|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below tx segment"|1 Month post treatment (no baseline)|Data available at 1- month follow-up visit|||limbs|limbs||Number
2802446|NCT00509392|Primary|Ecchymosis|"0-5 scale (5 most severe) 0: None~<25%~25-50%~50-75%~75-100%~Above or below tx segment"|2 Weeks post treatment (no baseline)|Intent to treat/ SP: Data available at 2-week follow-up visit|||limbs|limbs||Number
2802457|NCT00509366|Secondary|Drug Sensitivity Quartiles for Cisplatin and Pemetrexed|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity.|3 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates.||||||
2802458|NCT00509366|Secondary|Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)|The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84.|Baseline, Every 21 days for a maximum of 6 cycles|Of the 50 patients assigned treatment, only 32 patients completed the FACT-L assessment at baseline and at least one follow-up.|||units on a scale||Standard Error|Mean
2802459|NCT00509366|Secondary|Median Time to Progressive Disease|Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented.|1 Year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||months||95% Confidence Interval|Number
2802460|NCT00509366|Primary|1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients|One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.|1 year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.|||percentage of treated patients||95% Confidence Interval|Number
2802461|NCT00509288|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed listing of adverse events, see the adverse event module.|57 months||||Participants|||Number
2802462|NCT00509288|Primary|Clinical Tumor Regression.|Tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7/5/07-4/23/09||||Participants|||Number
2802463|NCT00509262|Secondary|Change From Baseline in Body Weight at Week 54||Baseline to Week 54|All participants as treated (APaT) population included participants who had both baseline and Week 54 data (excluding data after initiation of glycemic rescue therapy).|||kg||Standard Error|Least Squares Mean
2802464|NCT00509262|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54||Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.|||mg/dL||Standard Deviation|Mean
2802465|NCT00509262|Primary|Percentage of Participants With Hypoglycemic Events|Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.|Baseline up to 28 days following the last dose of study therapy|All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy.|||percentage of participants|||Number
2802466|NCT00509262|Primary|Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54|A1C represents percentage of glycosylated hemoglobin.|Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.|||Percent of glycosylated hemoglobin||Standard Deviation|Mean
2802467|NCT00509249|Primary|Hematological Response Rate|Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.0x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still > 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.|Up to 3 years||||participants|||Number
2802490|NCT00509093|Primary|Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment|Percent of participants less than 60 years of age with PFS at 8 and 13 months post-treatment|at 8 and 13 months after treatment.|All participants less than 60 years of age|||percent of participants|||Number
2802468|NCT00509236|Secondary|Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment|Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.|||Percent hemoglobin A1c||95% Confidence Interval|Least Squares Mean
2802469|NCT00509236|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.|||mg/dL||Standard Deviation|Mean
2802470|NCT00509236|Primary|Number of Participants With Clinical Adverse Events|Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.|54 Week Treatment Period + 28 days|All randomized participants.|||Participants|||Number
2802471|NCT00509236|Secondary|Number of Participants With Symptomatic Hypoglycemic Adverse Events|A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.|54 Week Treatment Period + 28 days|All randomized participants.|||Participants|||Number
2802472|NCT00509236|Primary|Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment|Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.|||Percent hemoglobin A1c||Standard Deviation|Mean
2802473|NCT00509223|Primary|HbA1c Change|Month 6 change in HbA1c (%)|Baseline to Month 6|The following definition was applied to the primary endpoint: included in analysis were all participants that had at least 1 follow-up HbA1c value in addition to the Baseline HbA1c were considered.|||HbA1c percent||Standard Deviation|Mean
2802474|NCT00509197|Secondary|Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)|Change in provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) after fluticasone or placebo treatment|Four weeks||||mg/ml||Standard Deviation|Mean
2802475|NCT00509197|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|Change in forced expiratory volume in one second (FEV1) after fluticasone or placebo treatment.|Four weeks||||L||Standard Deviation|Mean
2802476|NCT00509197|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment|Validated questionnaire assessing quality of life related to asthma after 4 weeks of treatment. The AQLQ is composed of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The AQLQ score is rated on a 7-point scale (1=maximal impairment, 7=no impairment) to yield a mean score out of 7. The worse the quality of life is , the lower the score is.|Four weeks||||units on a scale||Standard Deviation|Mean
2802477|NCT00509197|Primary|Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo|Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.|Four weeks|Intention to treat|||units on a scale||Standard Deviation|Mean
2802478|NCT00509106|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit|||||||
2802479|NCT00509106|Secondary|Microbiological Reinfection/Recurrence at LFU||21 to 35 days after last dose of study drug|||||||
2802480|NCT00509106|Secondary|Clinical Relapse at Late Follow Up (LFU) Visit||21-35 days after last dose of study drug|||||||
2802481|NCT00509106|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug|||||||
2802482|NCT00509106|Secondary|Overall Clinical and Radiographic Success Rate at TOC||8-15 days after last dose of study drug|||||||
2802483|NCT00509106|Secondary|Microbiological Success Rate at TOC||8-15 days after last dose of study drug|||||||
2802484|NCT00509106|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration|||||||
2802485|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug|||||||
2802486|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary~Failure: Any of the following:~Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy~Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia~Death wherein pneumonia (ie,CABP) was considered causative~Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.|||participants|||Number
2802487|NCT00509093|Other Pre-specified|Correlation of C-kit Expression With Multidrug Resistance Gene Expression (MDR1, MRP1, LRP, and BCRP) and AF1q Expression||24 months|||||||
2802492|NCT00509093|Primary|Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age|"PFS measured from the date of Complete Response (CR) to the date of relapse or death. Progression defined as any of the following event: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management~This outcome will be reported as median progression-free survival in months for participants less than 60 years of age."|up to 5 years from the End of Treatment|All participants less than 60 years of age|||months||Inter-Quartile Range|Median
2802493|NCT00509067|Secondary|MATRICS Verbal Learning and Memory|The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16.|Measured at Baseline and Weeks 8 and 16|intent to treat|||raw scores||Standard Deviation|Mean
2802494|NCT00509067|Secondary|Clinical Global Impression|The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill).|Measured at Baseline and Weeks 4, 8, 12, and 16|intent to treat|||units on a scale||Standard Deviation|Mean
2802495|NCT00509067|Primary|Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)|The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.|Measured at Baseline and Weeks 4, 8, 12, and 16|intent to treat|||units on a scale||Standard Deviation|Mean
2802496|NCT00509041|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 3 years)||||weeks||95% Confidence Interval|Median
2802497|NCT00509041|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)||||weeks||95% Confidence Interval|Median
2802498|NCT00509041|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 3 years)||||participants|||Number
2802499|NCT00509041|Primary|24 Week Progression Free Survival|Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|24 weeks||||percentage of participants||95% Confidence Interval|Number
2802500|NCT00509028|Secondary|Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline|Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).|54 weeks||||Percentage||Standard Deviation|Mean
2802501|NCT00509028|Secondary|Change From Baseline in Disturbance of Night-time Sleep|"Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization).~Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks||||Disturbances per night||Standard Deviation|Mean
2802502|NCT00509028|Secondary|Change From Baseline in Disturbance of Daily Activities|"Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization).~Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks||||Disturbances per day||Standard Deviation|Mean
2802503|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)|Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)|Baseline and 54 weeks||||Puffs per day||Standard Deviation|Mean
2802504|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)|Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)|Baseline and 54 weeks||||Puffs per day||Standard Deviation|Mean
2802505|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)|"Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization).~Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency."|Baseline and 54 weeks||||Points on a scale||Standard Deviation|Mean
2802506|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)|"Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4.~0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency"|Baseline and 54 weeks||||Points on a scale||Standard Deviation|Mean
2802507|NCT00509028|Secondary|Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal|Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).|54 weeks||||Percentage||Standard Deviation|Mean
2802508|NCT00509028|Secondary|Weight|Weight, change from baseline calculated as (weight at last visit - weight at randomization)|Baseline and 54 weeks||||kilograms||Standard Deviation|Mean
2802509|NCT00509028|Secondary|Height|Height, change from baseline calculated as (height at last visit - height at randomization)|Baseline and 54 weeks||||Centimeters||Standard Deviation|Mean
2802512|NCT00509028|Secondary|Number of Patients With Abnormal Clinical Laboratory Test Values.|"Analysis of haematological, clinical chemistry and urynalysis variables were performed.~Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count.~Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen.~Urinalysis variables: protein, glucose, urobilinogen, occult."|54 weeks||||Participants|||Number
2802513|NCT00509028|Primary|Number of Patients With Adverse Events (AEs).|AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.|54 weeks||||Participants|||Number
2802514|NCT00509002|Primary|Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy|The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or > new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design.|Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal||||Participants|||Count of Participants
2802515|NCT00508924|Primary|Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.|"Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30~Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay"|30 Days||||participants|||Number
2802516|NCT00508924|Primary|Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.||5 - 10 min after initial bolus||||second||Inter-Quartile Range|Median
2802517|NCT00508872|Primary|Complete Gross Resection Rate|Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).|Over 4 year study period|Intended analysis was per protocol. Study terminated early, leading to only two (2) patients recruited, one not eligible for study and second inevaluable.||||||
2802518|NCT00508820|Secondary|Platelet Response (Definition 2)|Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants|||Participants|||Number
2802519|NCT00508820|Secondary|Platelet Response (Definition 1)|Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants|||Participants|||Number
2802520|NCT00508820|Primary|Adverse Events|One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once|Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.|Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim|||participants|||Number
2802521|NCT00508755|Primary|Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.|Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.|visit 48, following treatment|The sample size for this feasibility study was n=6, constrained by funding limit.|||participants|||Number
2802522|NCT00508742|Secondary|Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age||Month 7, 12, 13, 18, 24|Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.|||percentage of participants||95% Confidence Interval|Number
2802523|NCT00508742|Primary|Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age|A new acquisition was defined as the detection of a serotype (here 6A' [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.|Month 7 through Month 24|Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2802524|NCT00508716|Primary|Re-hospitalization or Death|Number of participants who are re-hospitalized or die within 90 days of discharge|90 days||||participants|||Number
2802525|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3|Post-Dose 3 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
2802526|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2|Post-Dose 2 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
2802969|NCT00504556|Primary|Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)|liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities|3 months|safety analysis set|||percent subjects with liver related MA||95% Confidence Interval|Number
2802527|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1|Post-Dose 1 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
2802528|NCT00508651|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline|Pre-dose GMT of HAI antibody to HPIV3|Baseline (Day 0 prior to Dose 1)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.|||GMT||95% Confidence Interval|Mean
2802529|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid phenotype data are available|||samples containing vaccine-like virus|Participants||Number
2802530|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid genotype data are available|||samples containing vaccine-like virus|Participants||Number
2802531|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.|||participants|||Number
2802532|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.|||participants|||Number
2802533|NCT00508651|Secondary|Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.|||participants|||Number
2802534|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802535|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802536|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802537|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802538|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802970|NCT00504556|Secondary|Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of Cmin,ss; Cmax,ss|3 months||||ng/mL||Full Range|Median
2802539|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802540|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802541|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802542|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1||Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802543|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802544|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802545|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802546|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.|||participants|||Number
2802547|NCT00508651|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after final dose|Safety population was randomized participants who received investigational product and had any safety follow-up, including a temperature measurement, SE, AE, concomitant medication use, or follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).|||participants|||Number
2802548|NCT00508651|Primary|Number of Participants With SAEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
2802549|NCT00508651|Primary|Number of Participants With SAEs After Dose 2|One participant had event of pneumonia after Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
2802550|NCT00508651|Primary|Number of Participants With Serious Adverse Events (SAEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
2802551|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
2802552|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
2802553|NCT00508651|Primary|Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participant|||Number
2802554|NCT00508651|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
2802971|NCT00504556|Secondary|Effects on Biomarker Prothrombin Fragments|Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)|3 months||||pmol/L||Standard Deviation|Mean
2802555|NCT00508651|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)|||participants|||Number
2802556|NCT00508651|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose).|||participants|||Number
2802557|NCT00508651|Primary|Number of Participants With SEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.|||participants|||Number
2802558|NCT00508651|Primary|Number of Participants With SEs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
2802559|NCT00508651|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
2802560|NCT00508521|Primary|Fugl-Meyer Upper Limb Coordination Scale (FMUE)|A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.|baseline and after 12 weeks of training||||units on a scale||Standard Deviation|Mean
2802561|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 12th week of follow-up|ITT analysis was used.|||percentage of participants|||Number
2802562|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 4th week of follow-up|ITT analysis was used|||percentage of participants|||Number
2802563|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||over 4 weeks of treatment|ITT analysis was used.|||percentage of participants|||Number
2802564|NCT00508482|Secondary|Time to the First Spontaneous Bowel Movement After the First Treatment||counting by hours|ITT analysis was used|||hours||Standard Deviation|Mean
2802565|NCT00508482|Secondary|Change of Mean Value of Cleveland Clinic Score|Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used|||units on a scale||Inter-Quartile Range|Median
2802566|NCT00508482|Secondary|Change of Mean Value of Abdominal Distention|Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.|||units on a scale||Standard Deviation|Mean
2802567|NCT00508482|Secondary|Change of Mean Value of Stool Consistency|Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.|||units on a scale||Standard Deviation|Mean
2802568|NCT00508482|Secondary|Change of Mean Value of Incomplete Evacuation|Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used.|||units on a scale||Inter-Quartile Range|Median
2802569|NCT00508482|Secondary|Change of Mean Value of Straining During Defecating|Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used|||units on a scale||Standard Deviation|Mean
2802570|NCT00508482|Primary|Change of Mean Weekly Spontaneous Bowel Movements|Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.|over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up|Intention-To-Treat(ITT) analysis was used.|||stools/week||Inter-Quartile Range|Median
2802571|NCT00508469|Primary|Adherence|Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.|6 months|Per protocol|||percentage of adherent patients|||Number
2802972|NCT00504556|Secondary|Effects on Biomarker D-dimer|Mean (SD) change from baseline in D-dimer|3 months||||ng/mL||Standard Deviation|Mean
2802572|NCT00508404|Secondary|Resection Rate|The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
2802573|NCT00508404|Secondary|Time to Disease Relapse Following Surgical Intervention|Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set participants who underwent surgery|||months||95% Confidence Interval|Median
2802574|NCT00508404|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
2802575|NCT00508404|Secondary|Duration of Stable Disease|Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with a best response of SD|||months||95% Confidence Interval|Median
2802576|NCT00508404|Secondary|Time to Disease Progression|Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
2802577|NCT00508404|Secondary|Progression-free Survival|Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, and had evaluable KRAS status data)|||months||95% Confidence Interval|Median
2802578|NCT00508404|Secondary|Time to Initial Objective Response|Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set|||months||95% Confidence Interval|Median
2802579|NCT00508404|Secondary|Duration of Response|Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with an objective response (CR or PR)|||months||95% Confidence Interval|Median
2802580|NCT00508404|Secondary|Disease Control Rate|"The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator.~Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
2802581|NCT00508404|Secondary|Objective Response by 17 Weeks|The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.|Up to Week 17|KRAS Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
2802604|NCT00508261|Secondary|Anti-HBs Antibody Concentrations|The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||mIU/mL||95% Confidence Interval|Geometric Mean
2802973|NCT00504556|Primary|Adjudicated Incidence of Bleeding Events|Adjudicated Incidence of Bleeding Events during treatment period|3 months|safety analysis set|||percent of subjects with outcome event||95% Confidence Interval|Number
2802582|NCT00508404|Primary|Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.~Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.~Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, had evaluable KRAS status data, and with at least 1 unidimensionally measurable lesion per modified RECIST by the local investigator)|||percentage of participants||95% Confidence Interval|Number
2802583|NCT00508391|Primary|Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device|The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.|60 days after enrollment||||Percent of Subjects|||Number
2802584|NCT00508391|Primary|"Percentage of Subjects Classified as Not Worsened for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing"|"The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified not worsened if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105."|60 days after enrollment|Study utilized an intention-to-treat analysis. 111 out of 122 enrolled subjects completed the primary endpoint follow-up. 106 of these subjects met analysis criteria based on paired quality of life and six-minute walk data at the one and two month visits. Subjects not included in analysis either withdrew consent or had incomplete study measures.|||Percent of Subjects|||Number
2802585|NCT00508300|Secondary|Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort||30 days|||||||
2802586|NCT00508300|Primary|Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal))|Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25|30 days|accorindg to intention-to-treat principle|||days||Inter-Quartile Range|Median
2802587|NCT00508274|Secondary|Central Nervous System as First Site of Relapse|Number of participants who have Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product|||participants|||Number
2802588|NCT00508274|Secondary|Duration of Response|Duration of response is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product|||Months||Full Range|Median
2802589|NCT00508274|Secondary|Time to Response|Time to response is defined as the time from first dose date until first documentation of disease response.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product|||Months||Full Range|Median
2802590|NCT00508274|Secondary|Six Months Progression-Free Survival|Six Months Progression-Free Survival is defined as the percentage of surviving participants who are free of disease progression longer than six months (greather than 180 days) after the first start date of study treatment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Mean
2802591|NCT00508274|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||Months||Full Range|Median
2802605|NCT00508261|Secondary|Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs|The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802592|NCT00508274|Primary|Clinical Benefit Rate (CBR)|"CBR is defined by the percentage of participants achieving either a confirmed tumor reponse or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A partial response requires a decrease of 30% or more, Progression requires an increase of at least 20%, and Stable disease falls in between these two. All responses have a repeat assessment to confirm the response."|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Mean
2802593|NCT00508261|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|From dose 1 (Month 0) up to study end (Month 7)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2802594|NCT00508261|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.~The analysis was based only on subjects receiving a second dose of vaccination."|Occurring within Day 0-30 following vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2802595|NCT00508261|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Occurring within Day 0-30 following vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2802596|NCT00508261|Secondary|Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)|Any was defined as occurrence of at least one symptom experienced.|Day 0 - Month 7|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2802597|NCT00508261|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)|Any was defined as occurrence of at least one symptom experienced.|Day 0 - Month 7|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2802598|NCT00508261|Secondary|Number of Subjects Reporting Any Rash|Any was defined as occurrence of at least one symptom experienced.|Day 0 - Month 7|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2802599|NCT00508261|Secondary|Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose|"Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship.~Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination."|During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2802600|NCT00508261|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination|The analysis was based only on subjects receiving combined-diphtheria vaccination.|During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after the Infanrix-hexa vaccination. Subjects in the Meningitec Group did not receive any Infanrix-hexa and hence are not included in this analysis.|||Participants|||Count of Participants
2802601|NCT00508261|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.|During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after meningococcal vaccination.|||Participants|||Count of Participants
2802602|NCT00508261|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||EL.U/mL||95% Confidence Interval|Geometric Mean
2802603|NCT00508261|Secondary|Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens|"Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration < 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination.~The analysis was based only on subjects receiving experimental vaccination."|1 month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component prior to (M0) and after vaccination (M1).|||Participants|||Count of Participants
2802636|NCT00508157|Secondary|Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16|Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802606|NCT00508261|Secondary|Anti-PRP Antibody Concentrations|The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||μg/mL||95% Confidence Interval|Geometric Mean
2802607|NCT00508261|Secondary|Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off|The cut-off for the assay was ≥ 1.0|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802608|NCT00508261|Secondary|Anti-polio Type 1, 2 & 3 Titers|The results for the assay were tabulated as geometric mean expressed in titers.|At month 0, 1 and 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Titers||95% Confidence Interval|Geometric Mean
2802609|NCT00508261|Secondary|Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off|The cut-off for the assay was ≥ 1:8.|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802610|NCT00508261|Secondary|Anti-diphtheria (Anti-D) Antibody Concentrations|The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||IU/mL||95% Confidence Interval|Geometric Mean
2802611|NCT00508261|Secondary|Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off|The cut-off for the assay was ≥ 0.1|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802612|NCT00508261|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||IU/mL||95% Confidence Interval|Geometric Mean
2802613|NCT00508261|Secondary|Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)|The cut-off for the assay was ≥ 0.1|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802614|NCT00508261|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations|The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||μg/mL||95% Confidence Interval|Geometric Mean
2802615|NCT00508261|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off|The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802616|NCT00508261|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers|The results were tabulated as geometric mean expressed in titers.|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Titers||95% Confidence Interval|Geometric Mean
2802617|NCT00508261|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for the assay were ≥ 1:8 and ≥ 1:128|At month 0, month 1 and month 2|"ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1)."|||Participants|||Count of Participants
2802618|NCT00508261|Primary|Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off|The cut-off for the assay was ≥ 1μg/mL.|1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at Day 0.|||Participants|||Count of Participants
2802619|NCT00508261|Primary|Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off|The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).|1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. The analysis for the primary outcome measure was based only on subjects receiving Infanrix-hexa vaccination at Month 1.|||Participants|||Count of Participants
2802620|NCT00508261|Primary|Anti-PT, Anti-FHA and Anti-PRN Concentrations|The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|1 month after the first vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at month 1.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2802621|NCT00508261|Primary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.|The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.|1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2802622|NCT00508196|Secondary|Cardiac Output|measured at peak exercise on a standard exercise bicycle, measured non-invasively using the inert gas rebreathing technique (Innocor, Innovision A/S, Odense, Denmark).|1 week||||L/min||Standard Deviation|Mean
2802623|NCT00508196|Secondary|B-type Natriuretic Pepetide||1 week||||microgrammes /L||Standard Deviation|Mean
2802624|NCT00508196|Primary|Endothelial Function Assessed by Flow Mediated Vasodilatation|"Flow mediated vasodilatation as measured by reactive hyperaemia peripheral arterial tonometry signal using EndoPAT software, Itamar.~A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index (EnFI)"|1 week||||EndoPAT index (EnFI)||Standard Deviation|Mean
2802625|NCT00508183|Secondary|Healing Rate|Percentage of Participants who had healed by 1 year post-surgery as measured using magnetic resonance imaging. If the tendons were in continuity with no evidence of full-thickness tearing, the repair was considered healed (intact).|1 Year||||percentage of patients|||Number
2802626|NCT00508183|Secondary|Strength Test|Shoulder strength in forward elevation was measured in kg using a portable scale.|2 Years||||kg||Standard Deviation|Mean
2802627|NCT00508183|Secondary|ASES Score|Determination of differences in outcome between the two groups as measured by the American Shoulder and Elbow Surgeons (ASES) score. The ASES score ranges from 0 to 100 with a higher number indicative of better function.|2 Year||||units on a scale||Standard Deviation|Mean
2802628|NCT00508183|Secondary|Constant Score|Differences in outcome between the two groups as measured by the Constant score. The constant score ranges from 1 to 100 with a higher value indicative of better shoulder function.|2 Year||||units on a scale||Standard Deviation|Mean
2802629|NCT00508183|Primary|Western Ontario Rotator Cuff Index (WORC)|Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.|2 years||||units on a scale||Standard Deviation|Mean
2802630|NCT00508157|Secondary|Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16|IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802631|NCT00508157|Secondary|Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16|The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.|Baseline, Week 4, Week 8,Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802632|NCT00508157|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802633|NCT00508157|Secondary|Median Change From Baseline in Body Mass Index (BMI) Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802634|NCT00508157|Secondary|Mean Change From Baseline in Body Weight Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802635|NCT00508157|Secondary|Mean Change From Baseline for Fasting Glucose Levels Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.||||||
2802637|NCT00508157|Secondary|Number of Participants Remaining on Metabolic Syndrome at Week 16|Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.|Week 16|LOCF, Safety Sample For handling missing values, the metabolic syndrome is assumed to be ongoing unless there is enough data to support the resolution of the metabolic syndrome.|||participants|||Number
2802638|NCT00508157|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16|Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.|Baseline, Week 16|Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available.|||percent change||Standard Error|Mean
2802639|NCT00508144|Primary|Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)|"Complete Response (CR): Complete disappearance of all measurable & non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers & other abnormal lab values.~Partial Response (PR): Applies only to those with at least one measurable lesion. >/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline.~Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician.~Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles)."|Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks|Of 58 eligible participants, only 54 treated were available for response and five (5) experienced an early death, five (5) were later deemed inevaluable, and two had an indeterminate response.|||Participants|||Count of Participants
2802640|NCT00508118|Secondary|Transcranial Doppler Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
2802641|NCT00508118|Secondary|Cerebral Oximetry Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
2802642|NCT00508118|Secondary|Bispectral Index Scores (BIS)||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
2802643|NCT00508118|Secondary|Time Points for SSEP Latency and Amplitude Changes||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
2802644|NCT00508118|Secondary|Time Points of EEG Patterns||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
2802645|NCT00508118|Secondary|Temperature at Which Ablation of(SSEP)Occurs||Day of surgery through discharge|No participants were analyzed due to study terminated early.||||||
2802646|NCT00508118|Secondary|Temperature at Which ECS Occurs||Day of surgery through discharge|No participants analyzed due to study terminated early.||||||
2802647|NCT00508118|Primary|Duration From Initiation of Cardiopulmonary Bypass (CPB) to Electrocerebral Silence (ECS), Defined as no Discernable Electroencephalographic Activity at an Amplification of 2 Micro Volts (μV)/mm, Confirmed for 3 Minutes||Day of surgery|3 SUBJECTS PER PROTOCOL.|||Time (minutes)||95% Confidence Interval|Median
2802648|NCT00508105|Secondary|American Shoulder and Elbow Score|The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.|2 Years||||ASES Score||Standard Deviation|Mean
2802649|NCT00508105|Secondary|Western Ontario Osteoarthritis of the Shoulder Index|The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.|2 Years||||WOOS Score||Standard Deviation|Mean
2802650|NCT00508105|Primary|Subscapularis Strength|Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in pounds of force.|2 years||||kg||Standard Deviation|Mean
2802651|NCT00508027|Primary|Change in Serum Creatinine Levels|Change in serum creatinine (Cr) levels after treatment with simvastatin|Baseline, 21 days||||mg/dL||Standard Deviation|Mean
2802652|NCT00508027|Primary|Change in Serum Alanine Transaminase (ALT) Levels|Change in serum alanine transaminase (ALT) after treatment with simvastatin|Baseline, 21 days||||U/L||Standard Deviation|Mean
2802653|NCT00508027|Primary|Change in Serum Creatine Kinase Levels|Change in serum creatine kinase (CK) levels after treatment with simvastatin|Baseline, 21 days||||U/L||Standard Deviation|Mean
2802654|NCT00508027|Primary|Change in Hemoglobin Level|Change in plasma hemoglobin (Hb) level after treatment with simvastatin|Baseline, 21 days||||gm/dL||Standard Deviation|Mean
2802655|NCT00508027|Primary|Change in Total Cholesterol Level|Change in serum total cholesterol level after treatment with simvastatin|Baseline, 21 days||||mg/dL||Standard Deviation|Mean
2802656|NCT00508027|Other Pre-specified|Change in Plasma TF Levels|Change in plasma tissue factor (TF) levels after treatment with simvastatin|Baseline, 21 days||||pg/mL||Standard Deviation|Mean
2802657|NCT00508027|Other Pre-specified|Change in Plasma VCAM1 Levels|Change in plasma vascular cellular adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days||||ng/mL||Standard Deviation|Mean
2802658|NCT00508027|Other Pre-specified|Change in Plasma VEGF Levels|Change in plasma vascular endothelial adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days||||pg/mL||Standard Deviation|Mean
2802661|NCT00508027|Other Pre-specified|Change in Plasma NOx Levels|Measurements of the levels of plasma nitric oxide metabolites (NOx), high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), tissue factor (TF) and vascular endothelial growth factor (VEGF)were performed before and after simvastatin treatment. Changes in mean plasma biomarker levels were assessed for each dose level; however, dose level 3 results were not analyzed, as only 2 subjects were enrolled in this dose group.|Baseline, 21 days|All participants for whom plasma biomarker levels were recorded at baseline and 21 days|||micromolar||Standard Deviation|Mean
2802662|NCT00508001|Secondary|Overall Survival|Overall survival defined as the time from randomization (start of treatment) until death from any cause.|assessed up to 360 days|The analysis performed in the intent-To-Treat population.|||Days||95% Confidence Interval|Median
2802663|NCT00508001|Secondary|Progression-free Survival|Progression-free survival defined as the period from date of randomization(start of treatment) to date of disease progression or death.|from the date of randomisation to the date of documented disease progression or death for any cause|The analysis has been performed in the Intent-To-Treat (ITT) population.|||Days||95% Confidence Interval|Mean
2802664|NCT00508001|Secondary|Objective Response Rate|"Objective Response rate defined as percentage of patients with Complete Response [CR] or Partial Response [PR] based on Response Evaluation Criteria in Solid Tumours (RECIST).~Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions as assessed by Magnetic Resonance Imaging (MRI). Complete response (CR) must have disappearance of all target and non-target lesions as assessed by MRI."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.|||percentage of patients|||Number
2802665|NCT00508001|Primary|Tumour Stabilisation Rate|"Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for >=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST).~Complete Response - Disappearance of all target lesions; Partial Response - >=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - >=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.|||percentage of patients|||Number
2802666|NCT00507819|Secondary|Change From Baseline in Mean Minute Ventilation (L/Min) at 6 Weeks|Minute ventilation measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||L/min||Standard Deviation|Mean
2802667|NCT00507819|Secondary|Change From Baseline in Mean Respiratory Rate (Breaths/Min) at 6 Weeks|Respiratory rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||breaths/min||Standard Deviation|Mean
2802668|NCT00507819|Secondary|Change From Baseline in Mean Heart Rate (Bpm) at 6 Weeks|Heart rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||bpm||Standard Deviation|Mean
2802669|NCT00507819|Primary|Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks|Oxygen consumption measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks||||mL/kg/min||Standard Deviation|Mean
2802670|NCT00507767|Primary|Number of Participants With Progression-free Survival at 12-weeks|Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.|At 12-weeks|Analysis per protocol.|||participants|||Number
2802671|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 96|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.|||percentage of participants|||Number
2802672|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 72|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.|||percentage of participants|||Number
2802673|NCT00507689|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96||Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.|||percentage of participants|||Number
2802674|NCT00507689|Secondary|Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72||Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.|||percentage of participants|||Number
2802675|NCT00507689|Secondary|Percentage of Participants With HBV Recurrence at Week 96|HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.|||percentage of participants|||Number
2802676|NCT00507689|Primary|Percentage of Participants With HBV Recurrence Prior to or at Week 72|HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.|Pretreatment baseline through Week 72|Full Analysis Set|||percentage of participants|||Number
2802677|NCT00507559|Secondary|Effectiveness: Thrombosis|Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure|5 years|Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected|||participants|||Number
2802678|NCT00507559|Secondary|Effectiveness: Type I Endoleak and Type III Endoleak|Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure|12 months|Denominator is the number of subjects with adequate CT imaging available at 12 months|||participants|||Number
2802679|NCT00507559|Secondary|Effectiveness: Prosthesis Migration|Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure|12 months|The denominator is the number of subjects with adequate CT imaging available at 12 months|||participants|||Number
2802680|NCT00507559|Secondary|Effectiveness: EndoStaple Stent/Fracture|Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure|12 months|Denominator is number of subjects with adequate x-ray imaging available at 12 months|||participants|||Number
2802681|NCT00507559|Secondary|Effectiveness: Aneurysm Change|Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure|12 months|Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline.|||participants|||Number
2802682|NCT00507559|Secondary|Effectiveness: Aneurysm Rupture|Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure|12 months|143 reflects the number of subjects with data for the 12 month visit.|||participants|||Number
2802683|NCT00507559|Secondary|Effectiveness: Surgical Conversion|"Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure.~Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device."|12 months|143 reflects the number of subjects with data for the 12 month visit.|||participants|||Number
2802684|NCT00507559|Secondary|Safety: SAE (Serious Adverse Event)|Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure|5 years||||participants|||Number
2802685|NCT00507559|Primary|Safety: MAE (Major Adverse Event)|Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group|30 days||||participants|||Number
2802686|NCT00507559|Primary|Effectiveness: Composite Success Rate|Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.|12 months||||participants|||Number
2802687|NCT00507546|Secondary|Change in Subjective Morning Alertness|Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment|10 weeks||||units on a scale||Full Range|Median
2802688|NCT00507546|Primary|Amount of Wakefulness After Sleep Onset (WASO)|Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment|10 weeks|All participants who completed the entire protocol.|||Minutes||Full Range|Median
2802689|NCT00507507|Secondary|Occurrence of HBV Resistance Mutations|The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192).|Baseline to Week 192|Genotyping was attempted for all participants with HBV DNA ≥ 400 copies/mL at Week 48, 96, 144, 192 and/or the early discontinuation visit, and for all participants (with HBV DNA ≥ 400 copies/mL) after Week 192 who were on study for at least 216 weeks when the last participant reached Week 192.|||participants|||Number
2802690|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192|The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Weeks 48, 96, 144, and 192|Full Analysis Set|||participants|||Number
2802691|NCT00507507|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192|The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Weeks 48, 96, 144, and 192|Full Analysis Set|||participants|||Number
2802692|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192|"The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.|||participants|||Number
2802693|NCT00507507|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192|"The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.|||participants|||Number
2802694|NCT00507507|Secondary|Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192|Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set|||participants|||Number
2802695|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 192|The change from baseline in HBV DNA at Week 192 was analyzed.|Baseline to Week 192|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
2802696|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 144|The change from baseline in HBV DNA at Week 144 was analyzed.|Baseline to Week 144|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
2802699|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192|The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
2802700|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144|The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, and 144|Full Analysis Set|||percentage of participants|||Number
2802701|NCT00507507|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192|The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Week 192|Full Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2802702|NCT00507455|Secondary|Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
2802703|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
2802704|NCT00507455|Secondary|Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
2802705|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||units on a scale||Standard Error|Least Squares Mean
2802706|NCT00507455|Secondary|Change From Baseline in Volume Voided Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||mL||Standard Error|Least Squares Mean
2802707|NCT00507455|Secondary|Change From Baseline in Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population who had 3-day averaged incontinence episodes >0 at Baseline and with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||incontinence episodes||Standard Error|Least Squares Mean
2802708|NCT00507455|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours|"For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.~The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||urgency episodes||Standard Error|Least Squares Mean
2802742|NCT00507208|Primary|Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors|Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement.|12 months||||participants|||Number
2802709|NCT00507455|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||micturitions||Standard Error|Least Squares Mean
2802710|NCT00507455|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
2802711|NCT00507455|Secondary|Change From Baseline in IPSS Storage Score|"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
2802712|NCT00507455|Secondary|Change From Baseline in IPSS Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
2802713|NCT00507455|Secondary|Change From Baseline in International Prostate Symptoms Score (IPSS)|"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:~Sensation of incomplete emptying~Repeat urinating after 2 hours (frequency)~Start and stop several times (intermittency)~Urgency~Weak stream~Straining~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.|||units on a scale||Standard Error|Least Squares Mean
2802714|NCT00507455|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment.|||participants|||Number
2802715|NCT00507455|Secondary|Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)|"Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency.~LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.|||Percent voiding efficiency||Standard Error|Least Squares Mean
2802716|NCT00507455|Secondary|Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)|"The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2802717|NCT00507455|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.|||mL/sec||Standard Error|Least Squares Mean
2803628|NCT00498628|Primary|Percent Heavy Drinking Days|A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.|Weeks 3 - 11|Intention to Treat|||percentage of heavy drinking days||Standard Error|Least Squares Mean
2802718|NCT00507455|Secondary|Change From Baseline in Post Void Residual Volume (PVR)|"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~End-of-treatment is the last post-baseline assessment during the treatment period.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set (FAS) population with available data at each time point (as indicated by N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."|||mL||Standard Error|Least Squares Mean
2802719|NCT00507455|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.|||cmH2O||Standard Error|Least Squares Mean
2802720|NCT00507442|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death|Up to 48 weeks or until death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||days||95% Confidence Interval|Median
2802721|NCT00507442|Secondary|Probability of 1-year Survival||survival probability at 1 year after randomization|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||percentage of patients|||Number
2802722|NCT00507442|Secondary|Progression-free Survival|"Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression/death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||days||95% Confidence Interval|Median
2802723|NCT00507442|Secondary|Time to Response|Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.|Up to 48 weeks or until disease response|Responders (patients achieved complete and partial response) in the response evaluable population.|||days||Full Range|Median
2802724|NCT00507442|Secondary|Time to Disease Progression|"Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.|||days||95% Confidence Interval|Median
2802725|NCT00507442|Secondary|Duration of Response|"Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|Responders (patients achieved complete and partial response) in the response evaluable population.|||days||95% Confidence Interval|Median
2802726|NCT00507442|Secondary|Number of Patients With Complete Response Rate + Near Complete Response Rate|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
2802727|NCT00507442|Secondary|Number of Patients With Stringent Complete Response Rate|Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
2802728|NCT00507442|Secondary|Number of Patients With Overall Response|"Overall Response includes complete response and partial response.~Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
2802729|NCT00507442|Secondary|Number of Patients With Adverse Events (AEs)|Evaluate the safety and tolerability of the combination therapy|From first dose of study drug through the 30 day post-treatment AE assessment visit|The safety population includes patients received any dose of any study drug.|||participants|||Number
2802743|NCT00507130|Secondary|Terminal Phase Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis|||Day||Standard Deviation|Mean
2802730|NCT00507442|Primary|Number of Patients With Combined Complete Response and Very Good Partial Response|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h"|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.|||participants|||Number
2802731|NCT00507429|Secondary|To Determine Percentage of 1 Year Survival||from randomization through end of study visit|Intent to treat|||percentage of participants|||Number
2802732|NCT00507429|Secondary|To Determine Progression Free Survival||from randomization through end of study visit|||||||
2802733|NCT00507429|Primary|Overall Survival||From randomization to date last known alive|All randomized subjects (the Intent-to-treat population) included in the analysis|||months||95% Confidence Interval|Median
2802734|NCT00507416|Secondary|Change From Baseline in EORTC QLQ-C30 - Global Health Status|"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement."|Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13|"Intent-to-treat population with available data at each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
2802735|NCT00507416|Secondary|Time to Alternative Therapy|Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.|From randomization until alternative therapy. Median follow-up time was 43 months.|Intent to Treat|||months||95% Confidence Interval|Median
2802736|NCT00507416|Secondary|Overall Survival|Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.|From randomization until death. Median follow-up time was 43 months.|Intent to treat|||months||95% Confidence Interval|Median
2802737|NCT00507416|Secondary|Duration of Response|Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.|From first documented response until disease progression. Median follow-up time was 43 months.|Participants with an overall response|||months||95% Confidence Interval|Median
2802738|NCT00507416|Secondary|Percentage of Participants With a Complete Response or a Very Good Partial Response|"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.~Response was assessed by the Investigator using the IMWG uniform response criteria."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.|||percentage of participants|||Number
2802739|NCT00507416|Secondary|Percentage of Participants With a Complete Response|Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.|Response assessed every other cycle, for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.|||percentage of participants|||Number
2802740|NCT00507416|Secondary|Percentage of Participants With an Overall Response|"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.~CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).~PR requires 1 of the following:~≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or~If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or~If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.~If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.|||percentage of participants|||Number
2802741|NCT00507416|Primary|Progression Free Survival (PFS)|"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease"|From randomization until disease progression. Median follow-up time was 43 months.|Intent-to-treat (all randomized participants)|||months||95% Confidence Interval|Median
2802744|NCT00507130|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis|||Micrograms per milliliter||Standard Deviation|Mean
2802745|NCT00507130|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis|||Day||Standard Deviation|Mean
2802746|NCT00507130|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, 119, and 150|All subjects who received at least one dose of MEDI-528|||Participants|||Number
2802747|NCT00507130|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2802748|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results|Number of participants experiencing abnormal clinically significant MRI results|Days -14 to -1 and 28|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2802749|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results|Number of participants with abnormal clinically significant ECG results|Days -14 to -1, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2802750|NCT00507130|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2802751|NCT00507130|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2802752|NCT00506948|Primary|Number of Participants With Acute Graft-versus-host Disease (aGVHD)|Participants who had acute graft-versus-host disease (aGVHD) within 100 days post transplant. Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant||||participants|||Number
2802753|NCT00506948|Primary|Failure Rate|Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant|||||||
2802754|NCT00506922|Primary|Number of Patients Without GVHD at 100 Days|The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.|100 days|All analysis was intention to treat (ITT).|||participants|||Number
2802755|NCT00506909|Secondary|Arizona Sexual Experience Scale (ASEX)||Visits 1-8 (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802756|NCT00506909|Secondary|Paranoid Thought Scale||Visits 1-8 (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802757|NCT00506909|Secondary|Profile of Mood States||Visits 1 and 5 (first visit and 5 weeks later)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802758|NCT00506909|Secondary|California Verbal Learning Test-Second Edition||Visits 1, 4, and 8 (every 4 weeks)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802759|NCT00506909|Secondary|Reading Trust in the Eyes Test (RTET)||Visits 1, 4, 5 and 8 (every 4 weeks)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802760|NCT00506909|Secondary|Letter Number Sequencing Memory Test||Visits 1, 4, and 8 (every 4 weeks)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802761|NCT00506909|Secondary|Peabody Picture Vocabulary Test||Visit 1 only|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802762|NCT00506909|Secondary|Hamilton Anxiety Scale||performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802763|NCT00506909|Secondary|Global Assessment of Functioning||performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802764|NCT00506909|Secondary|Clinical Global Impression-Global Improvement||Performed at Visits 2-8 (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802765|NCT00506909|Secondary|Calgary Depression Scale for Schizophrenia||performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802766|NCT00506909|Secondary|Clinical Global Impression-Severity of Illness||performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802767|NCT00506909|Primary|Total Score in the Positive and Negative Syndrome Scale (PANSS)||performed at each visit (weekly)|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2802768|NCT00506883|Primary|Responders|Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.|24 hours after baseline|The Intent-to-Treat (ITT) population(N=184) was used. The ITT group is defined as all patients who were randomized,and had a qualifying gout flare based on contact with the Gout Flare Call Center, who were instructed to begin taking and took at least one dose of the study drug study drug. One patient had a flare, but|||Participants|||Number
2802769|NCT00506857|Secondary|Number of Participants With Graft Versus Host Disease (GVHD)|Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status.|5 years|Analysis was per protocol for 73 patients out of 80 patients due to 3 early deaths and 4 non engraftments.|||Participants|||Number
2802770|NCT00506857|Primary|Maximum Tolerated Dose (MTD)|"Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where toxicity is defined as grade 3 or 4 conventional toxicity [National Cancer Institute Common Toxicity Criteria (NCI-CTC)]. Participant evaluation in a cohort with each modality is 30 days."|1 month|Analysis was per protocol.|||mg/kg|||Number
2802771|NCT00506831|Secondary|Change in Serum Autoantibody Profile at 6 Months Compared to Baseline||6 months compared to baseline|No data were collected for this outcome measure||||||
2802772|NCT00506831|Secondary|Cell Types That Contribute to the Gene Expression Changes Associated With Imatinib Therapy|To determine which cell types may be contributing to the gene expression changes associated with imatinib therapy, imatinib-responsive genes were isolated from from patient biopsies. From the total number of imatinib-responsive genes that were isolated, the percentage that came from endothelial cells, fibroblasts, B-cells, and multiple cell types was calculated. Reported values do not total to 100% because of rounding.|6 months compared to baseline|Participants with available data were included in the analysis|||percentage of isolated genes|Isolated imantinib-responsive genes||Number
2802773|NCT00506831|Secondary|Change in Serum Cytokine Profile at 6 Months Compared to Baseline||6 months compared to baseline|No data were collected for this outcome measure||||||
2802774|NCT00506831|Secondary|Change in Dermal Thickness and Collagen Separation on Cutaneous Histopathology at 6 Months Compared to Baseline||6 months compared to baseline|Participants with available data were included in the analysis|||mm|||Number
2802775|NCT00506831|Secondary|Change in Scleroderma Health Assessment Questionnaire at 6 Months Compared to Baseline|Change in Health Assessment Questionnaire disability index at 6 months compared to baseline. The Questionnaire is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|6 months compared to baseline|Participants with available data were included in the analysis|||units on a scale||Full Range|Mean
2802776|NCT00506831|Secondary|Change in Digital Ulcerations at 6 Months Compared to Baseline|Number of digital ulcers as measured by physician assessment at 6 months compared to baseline|6 months compared to baseline|No data were collected for this outcome measure||||||
2802777|NCT00506831|Secondary|Change in Pulmonary Function Tests at 6 Months Compared to Baseline|Change in % predicted Forced Vital Capacity (FVC) at 6 months compared to baseline. FVC is the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.|6 months compared to baseline|Participants with available data were included in the analysis|||FVC% predicted||Full Range|Mean
2802778|NCT00506831|Primary|Percent Change in Modified Rodnan Skin Score at 6 Months Compared to Baseline|Modified Rodnan skin score (mRSS) on scale of 0 (no skin disease) to 51 severe skin disease. %change in mRSS=(score at 6 months - baseline score)/baseline score. Negative values indicate improvement in skin disease. Clinical important improvement defined as > 25% improvement.|6 months compared to baseline|Participants who completed the protocol were included in the analysis|||percentage of change in MRSS||Standard Deviation|Mean
2802779|NCT00506753|Primary|Crime: General Predatory Aggression|using the Misbehaviors Questionnaire, we collect 12 items that assess the average number of times crimes involving predatory aggression were committed at Baseline, 3 months and 6 month post release.|Baseline, 3 months post release and 6 months post release|Due to project drop out more people were analyzed at baseline than at both follow up assessments.|||Average # of times||Standard Deviation|Mean
2802780|NCT00506753|Primary|Marijuana Use|using Time-Line Follow-back, we collected average number of joints per smoking day|Baseline, 3 months post release and 6 month post release|Individuals dropped out of the study over time, more people were analyzed at baseline than at follow up assessments|||# of joints per smoking day||Standard Deviation|Mean
2802781|NCT00506753|Primary|Alcohol Use, Average # of Drinks Per Week|using Time-Line Follow-back, we collected average # of drinks per week for a 3 month period at Baseline, 3 months and 6 months post release|Baseline, 3 months post release and 6 months post release|Individuals dropped out of the project over time, more people were analyzed at Baseline than at each Follow-up assessment.|||average # of drinks per week||Standard Deviation|Mean
2802782|NCT00506714|Secondary|Gait Velocity|Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use|4 weeks|Analysis was per protocol|||cm/s||Standard Deviation|Mean
2802783|NCT00506714|Secondary|Gait Velocity With a Cane in Hip OA Subjects|Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.|Baseline|Analysis was per protocol|||cm/s||Standard Deviation|Mean
2802784|NCT00506714|Primary|Gait Velocity||Baseline|Analysis was per protocol|||cm/s||Standard Deviation|Mean
2802785|NCT00506675|Primary|Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks||||logMAR||Standard Deviation|Mean
2802786|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks||||Participants|||Number
2802787|NCT00506675|Primary|Mean (SD) Distribution of Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks||||logMAR||Standard Deviation|Mean
2802788|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks||||participants|||Number
2802789|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 5-7|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 5-7|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.|||episodes per week by visit||Standard Deviation|Mean
2802790|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 2-4|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 2-4|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.|||episodes per week by visit||Standard Deviation|Mean
2802791|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Month 1|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, month 1|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.|||episodes per week by visit||Standard Deviation|Mean
2802792|NCT00506662|Secondary|Change in Body Weight at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802793|NCT00506662|Secondary|Change in Body Weight at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802794|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802795|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802796|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802797|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802798|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802799|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802800|NCT00506662|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802801|NCT00506662|Primary|Change in Glycosylated Haemoglobin (HbA1c) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.||||||
2802802|NCT00506597|Primary|Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma|Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.|4 years||||participants|||Number
2802803|NCT00506597|Primary|Participant Toxicity Data|Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.|3 Years|||||||
2802804|NCT00506493|Secondary|Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|9 months||||percentage of subjects|||Number
2802805|NCT00506493|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months||9 months||||percentage of subjects|||Number
2802806|NCT00506493|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge||||percentage of subjects|||Number
2802807|NCT00506493|Primary|Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months|Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours|9 months|75 subjects were enrolled, 14 subjects had no Holter assessment performed- 6 subjects died, 5 subjects withdrew participation, and 3 subjects completed endpoint follow-up without analyzable Holter data.|||percentage of subjects|||Number
2802808|NCT00506454|Primary|Reduction in Endotoxin Levels.|The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.|Baseline and at 4 weeks||||Participants|||Number
2802809|NCT00506441|Secondary|Incidence of Adverse Events||12 weeks (Week 0-12) and 4 weeks (Week 12-16)|||||||
2802810|NCT00506441|Secondary|Change From Baseline in Triglyceride||12 weeks|||||||
2802811|NCT00506441|Secondary|Change From Baseline in VLDL Cholesterol||12 weeks|||||||
2802812|NCT00506441|Secondary|Change From Baseline in HDL Cholesterol||12 weeks|||||||
2802813|NCT00506441|Secondary|Change From Baseline in LDL Cholesterol||12 weeks|||||||
2802814|NCT00506441|Secondary|Change From Baseline in Total Cholesterol||12 weeks|||||||
2802815|NCT00506441|Secondary|Change From Baseline in Calcium x Phosphorus Ion Product||12 weeks|||||||
2802816|NCT00506441|Secondary|Change From Baseline in Calcium||12 weeks|||||||
2802817|NCT00506441|Secondary|Change From Baseline in PTH||12 weeks|||||||
2802818|NCT00506441|Secondary|Change From Baseline in Serum Phosphorus||12 weeks (Week 0 to Week 12)|ITT1 (The ITT1 population included all enrolled subjects who have taken at least one dose of study medication and have at least one central phosphorus value after the start of study medication.)|||mg/dL||95% Confidence Interval|Mean
2802819|NCT00506441|Primary|The Change in Serum Phosphorus From Week 12 to Week 16|The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)|4 weeks (Week 12 to Week 16)|Intent-to-treat (ITT) 2 (The ITT2 population included all subjects who complete 12-weeks, receive a randomization number and receive at least one dose of study medication in the placebo-controlled withdrawal phase, either MCI-196 or placebo, and have at least one central phosphorus value after 12-weeks.)|||mg / dL||Standard Deviation|Mean
2802820|NCT00506415|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events||30 days after a maximum of 96 weeks treatment|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.|||Participants|||Number
2802821|NCT00506415|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period|Change from baseline to week 48 as assessed by the Neuropsychiatric Inventory (NPI)-10 total score. The scale consists of 10 domains that are rated for both frequency (range 1-4) and severity (range 1-3). A composite score for each domain is calculated (frequency x severity) which ranges from 1 to 12. There is a leading question for each item. If the symptom is not present then the frequency, severity and distress scores are not completed. In this case the score is 0 for the item. The sum of the composite scores yields the NPI-10 total score (range 0-120). A negative change in score indicates an improvement from baseline (symptom reduction).|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients with an assessment at baseline and week 48, who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).|||units on a scale||Standard Deviation|Mean
2802822|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part B. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. TMT has two parts: Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-Part B except the person must alternate between numbers and letters. Total values for TMT part B range between 0 and 420 seconds. A negative change from baseline indicates an improvement in condition.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).|||Time in seconds||Standard Deviation|Mean
2802823|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part A. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. The score represents the amount of time required to complete the task. Total values for TMT part A range between 0 and 300 seconds. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog and ADCS-IADL).|||Time in seconds||Standard Deviation|Mean
2802824|NCT00506415|Secondary|Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period|Functional decline was defined by either an at least 1 point decrease in the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) subscale score in a visit and confirmed by the following visit/assessment or at least 2 points decrease from the double blind randomization baseline.|390 days was the maximum|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.|||Time in days||95% Confidence Interval|Median
2802977|NCT00504426|Primary|Pain (Subjective Symptom)|"Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline.~Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable."|Baseline and Week 4||||mm||Standard Deviation|Mean
2802825|NCT00506415|Primary|Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period|The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.|||units on a scale||Standard Deviation|Mean
2802826|NCT00506415|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period|The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.|||units on a scale||Standard Deviation|Mean
2802827|NCT00506389|Secondary|Average Subjective Total Sleep Time (TST) During the In-Treatment Period|TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.|||Minutes||Standard Deviation|Mean
2802828|NCT00506389|Secondary|Average Latency to Persistent Sleep (LPS) During the In-Treatment Period|LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.|||Minutes||Standard Deviation|Mean
2802829|NCT00506389|Primary|Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period|WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The Intent-to-Treat (ITT) group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.|||Minutes||Standard Deviation|Mean
2802830|NCT00506350|Secondary|Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed were H5N1 A/Indonesia and H5N1 A/Vietnam.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||T-cell/million cells||Inter-Quartile Range|Median
2802831|NCT00506350|Secondary|Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strains assessed wwere H5N1 A/Indonesia and H5N1 A/Vietnam.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||T-cells/million cells||Inter-Quartile Range|Median
2802832|NCT00506350|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection. The flu strain assessed was A/Indonesia/05/2005 (H5N1).|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Participants|||Count of Participants
2802833|NCT00506350|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|"Seroprotection rate was defined as the percentage of vaccines with a serum HI antibody titer ≥ 1:40 that usually is accepted as indicating protection.~The flu strain assessed was A/Indonesia/05/2005 (H5N1)."|At Days 0, 7, 14, 21, 28, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2802834|NCT00506350|Secondary|Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Fold increase||95% Confidence Interval|Geometric Mean
2802974|NCT00504556|Secondary|Incidence of Major Adverse Cardiac Events MACE)|MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition|3 months|safety analysis set|||percent of subjects experiencing events||95% Confidence Interval|Number
2802835|NCT00506350|Secondary|Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.|At Days 7, 14, 21, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2802836|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for neutralizing antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Participants|||Count of Participants
2802837|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for anti-HA antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:56 and at least a 4-fold increase in post-vaccination titer.|At Days 21 (post-vaccination one) and 42 (post-vaccination two)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2802838|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Participants|||Count of Participants
2802839|NCT00506350|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.|At Days 7,14, 21, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2802840|NCT00506350|Secondary|Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which consisted of all subjects who had serologic results available at the antibody persistence time point.|||Titers||95% Confidence Interval|Geometric Mean
2802841|NCT00506350|Secondary|Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Days 0, 7, 14, 21, 28, 35 and 42|The analysis was performed on the ATP cohort for immunogenicity, whiich included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2802842|NCT00506350|Secondary|Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005.|At Months 6, 12, 18 and 24|The analysis was performed on the ATP cohort for persistence, which included all subjects who had serologic results available at the antibody persistence time-point.|||Titers||95% Confidence Interval|Geometric Mean
2802843|NCT00506350|Secondary|Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Indonesia/05/2005. No subject from GSK1562902A AD F1 Primed Group has received a second vaccination.|At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2802844|NCT00506350|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 up to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2802845|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2802846|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2802847|NCT00506350|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2802848|NCT00506350|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. No subject from GSK1562902A AD F1 Primed Group has received Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2802849|NCT00506350|Primary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2802850|NCT00506350|Primary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was A/Indonesia/05/2005.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2802851|NCT00506350|Primary|Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2802852|NCT00506350|Primary|Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain|Seroconversion rate for HI antibody response was defined as the percentage of vaccines who have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2802853|NCT00506350|Primary|Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2802854|NCT00506350|Primary|Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain|Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2802855|NCT00506285|Secondary|Conners' Adult ADHD Rating Scales (CAARS)|Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.|Double-blind endpoints for MTS and placebo arms||||units on a scale||Standard Deviation|Mean
2802856|NCT00506285|Primary|Wender Reimherr Adult Attention Deficit Disorder Scale|This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.|Double-blind endpoints during MTS and placebo arms|"All subjects given active treatment last observation carried forward using a mixed models design."|||units on a scale||Standard Deviation|Mean
2802857|NCT00506155|Secondary|5-year Overall Survival (OS)|The overall survival rate stated as a five-year survival rate, which is the percentage of participants in study who are alive five years after the start of treatment.|5 years||||Percentage of Participants|||Number
2802858|NCT00506155|Primary|Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen|"Number of participants out of total with a response defined as downstaging to <= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of TNM; T describes size tumor & cancer spread into nearby tissue; N describes spread to nearby lymph nodes; & M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment."|Following 20 weeks of chemotherapy|All 60 participants completed at least 1 cycle of chemotherapy.|||Percentage of Participants|||Number
2802859|NCT00506142|Primary|Disease Control Rate|Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)|1 year||||Participants|||Count of Participants
2802860|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Working Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
2802861|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Episodic Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
2802862|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Attention/Processing Speed Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
2802863|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||Standard Error|Least Squares Mean
2802864|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score|The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
2802865|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
2802866|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
2802976|NCT00504426|Secondary|Improvement Rate of Pain (Doctor's Judgment)|"Percentage of participants qualified for improvement of pain by doctor's judgement.~Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend.~Improvement defind by stopped or almost stopped or alleviated."|Baseline and Week 4||||Percentage of Participants||95% Confidence Interval|Number
2802867|NCT00506077|Primary|Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.|||Composite T-score||95% Confidence Interval|Least Squares Mean
2802868|NCT00506064|Primary|Objective Sleep Response of Patients|Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)|Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative|Since unable to accrue an adequate number of cases with data, unable to provide analysis.||||||
2802869|NCT00506025|Primary|Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC)|The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).|7 months, from enrollment at 3 months of pregnancy to delivery|a priori for a pilot study|||cfu per ml||Full Range|Median
2802870|NCT00505934|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.|||Consecutive doses||Standard Deviation|Mean
2802871|NCT00505934|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
2802872|NCT00505934|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.|||Subjects|||Number
2802873|NCT00505921|Primary|Participant Progression Free Survival at 2 Years|Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.|2 years|Analysis was per protocol. Nine participants were not eligible for treatment therefore were excluded from analysis.|||participants|||Number
2802874|NCT00505895|Secondary|Acute Grade II-IV Graft Versus Host Disease (GVHD)|Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.|GVHD grading weekly during first 100 days; Annual examinations for nine year study period|For the acute GVHD analysis, only 48 patients’ data were available.|||percentage of participants|||Number
2802875|NCT00505895|Primary|Number of Participants With Successful Engraftment at Day 100||Day 100||||participants|||Number
2802876|NCT00505778|Secondary|Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6|Is your ulcerative colitis in remission (not active)? Y/N|6 months|ITT Population|||Percentage of Participants|||Number
2802877|NCT00505778|Secondary|Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6|MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.|6 months|ITT Population|||MARS Score||Standard Error|Mean
2802878|NCT00505778|Secondary|Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population|Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population|||Participants|||Number
2802879|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 12, ITT Population|Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|12 months|ITT Population|||Percentage of Participants|||Number
2802880|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 3, ITT Population|Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|3 months|ITT Population|||Percentage of Participants|||Number
2802881|NCT00505778|Primary|Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)|Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population|||Percentage of Participants|||Number
2802882|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 12 weeks|Participants administered SCoRS at both Baseline and 12 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
2802883|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 6 weeks|Participants administered SCoRS at both Baseline and 6 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
2802884|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, 12 weeks|Only participants with UPSA scores at both Baseline and 12 weeks were included in this analysis|||units on a scale||Standard Deviation|Mean
2802885|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, week 6|Only participants with UPSA scores at both Baseline and 6 weeks were included in this analysis|||units on a scale||Standard Deviation|Mean
2802886|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery (MCCB)|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, 12 weeks|Only participants with completed MCCB at both Baseline and 12 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
2802887|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery Composite Score Change|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, week 6|Only participants with completed MCCB at both baseline and 6 weeks were included in analysis|||units on a scale||Standard Deviation|Mean
2802888|NCT00505752|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percentage of participants|||Number
2802889|NCT00505752|Primary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||2PN oocytes||Standard Deviation|Mean
2802890|NCT00505687|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
2802891|NCT00505687|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
2802892|NCT00505687|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
2802893|NCT00505661|Primary|Objective Response Rate Following Treatment With Letrozole|Using RECIST criteria, Objective Response evaluated every 2 months.|2 month intervals for first 2 years|Analysis was per protocol, only 9 of 12 eligible patients were evaluable for response.|||participants|||Number
2802894|NCT00505635|Secondary|Number of Participants With Response|Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).|Following each 21 day cycles|||||||
2802975|NCT00504504|Primary|5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD|Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.|Baseline to 5 Years or until disease progression||||percentage of participants|||Number
2802895|NCT00505635|Primary|Time to Progression (TTP)|TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Following two 21 day cycles until disease progression||||days||Full Range|Geometric Mean
2802896|NCT00505622|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety population|||Hours||Standard Deviation|Mean
2802897|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study|Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety population|||Scores on a scale||Standard Deviation|Mean
2802898|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety Population|||Scores on a scale||Standard Deviation|Mean
2802899|NCT00505622|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel.|||Hours||Standard Deviation|Mean
2802900|NCT00505518|Primary|Nurse Telepsychiatry Services Satisfaction Questionnaire|"The charge nurse's satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: not satisfied, satisfied, and highly satisfied."|30 days or 60 days (length depended on clinical needs of patients)||||Participants|||Number
2802901|NCT00505518|Primary|Patient/Family Telepsychiatry Service Satisfaction Survey|"Patients' (or their family members' for those who had severe cognitive deficits) satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: not satisfied, satisfied, and highly satisfied."|30 days or 60 days (length depended on clinical needs of patients)||||participants|||Number
2802902|NCT00505518|Primary|Change in Mean Scores on Clinical Global Impressions|Minimum score - 1 (better outcome) Maximum score - 7 (worse outcome)|Baseline, 30 days or 60 days (length depended on clinical needs of patients)||||units on a scale||Standard Deviation|Mean
2802903|NCT00505414|Secondary|Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change (PGIC) is an instrument where the participant indicates their perceived change at the end of a treatment phase. The overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in tapentadol and morphine at Day 15 (Start of Maintenance Phase) and repeated in participants completing the Maintenance Phase in the Matching Placebo, Tapentadol and Morphine (Day 43).|Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phase|Full Analysis Set. Number of participants with data available.|||participants|||Number
2802904|NCT00505414|Primary|Responder Rates in Maintenance Period|"A responder is a participant in the study that:~completed 28 days of the maintenance phase~had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.~did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43).~A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder."|End of the 4 week Maintenance Phase (Day 43)|Full Analysis Set. Number of participants with data available.|||participants|||Number
2802905|NCT00505375|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years of follow up||||nmol/L||95% Confidence Interval|Geometric Mean
2802906|NCT00505362|Secondary|Operative Times|Operative time of the cesarean delivery in minutes.|From start to the end of the cesarean delivery, assessed up to two hours.||||minutes||Standard Deviation|Mean
2802920|NCT00505076|Secondary|Schizophrenia Cognition Rating Scale (SCoRS) Score|The Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. The SCoRS Interviewer Global Rating of function has a range 1 to 10. Higher ratings indicate greater impairment.|4 Weeks (Baseline to End of Treatment)|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.|||SCoRS Score||Standard Deviation|Mean
2802907|NCT00505362|Primary|Post-operative Pain|Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient's total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.|72-hour study period||||Scores on a scale||Standard Deviation|Mean
2802908|NCT00505284|Secondary|Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period|If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.|Baseline to Week 15|ITT Population|||Participants|||Number
2802909|NCT00505284|Secondary|Presence or Absence of Allodynia at Week 15/EOT|Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.|Week 15/EOT|ITT Population|||Participants|||Number
2802910|NCT00505284|Secondary|Withdrawal Due to Treatment Failure During Double-Blind Dosing Period|Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure.|Baseline and Week 15|ITT Population|||Participants|||Number
2802911|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores|HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21.|Baseline and Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2802912|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores|Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.|Baseline and Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2802913|NCT00505284|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT|At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.|Week 15/EOT|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.|||Participants|||Number
2802914|NCT00505284|Secondary|Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT|SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.|Baseline and Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2802915|NCT00505284|Secondary|Change in Average Sleep Interference Scores From Baseline to Week 15/EOT|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF.|Baseline to Week 15/EOT|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2802916|NCT00505284|Primary|Mean Change in Average Pain Scores From Baseline at Each Study Week|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.|Baseline, Week 1 to Week 17|ITT Population|||Scores on a Scale||Standard Deviation|Mean
2802917|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT.|||Percentage of Participants|||Number
2802918|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT.|||Percentage of Participants|||Number
2802919|NCT00505284|Primary|Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).|Baseline to Week 15/EOT|Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline.|||Scores on a Scale||Standard Deviation|Mean
2802921|NCT00505076|Secondary|UPSA(UCSD Performance-Based Skills Assessment) Summary Score|The UCSD Performance-Based Skills Assessment assessed functional capacity. The UPSA Summary Score has a range from 0 to 120. A higher score indicates less impairment.|Baseline and end of treatment, a total of four weeks.|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.|||UPSA Summary Score||Standard Deviation|Mean
2802922|NCT00505076|Primary|Composite MATRICS Consensus Cognitive Battery Score|The primary outcome measure is the composite score on the Matrics Consensus Cognitive Battery (MCCB). The MCCB composite score is a standardized mean of the seven domain scores. T-scores are standardized to normative data, and have an estimated mean of 50 and SD of 10 in the general healthy population. Data reduction for analysis of neurocognitive testing used the following steps: i) individual neurocognitive test scores at baseline and follow-up were converted to t-scores; ii) t-scores within the pre-specified cognitive domains measured by more than one test were averaged to obtain a domain-specific t-score; and iii) domain-specific t-scores were averaged to create the MCCB composite score.|4 weeks|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.|||composite score||Standard Deviation|Mean
2802923|NCT00504985|Primary|Patient Fatigue Severity Scores Assessed With MDASI|"Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0-10 numeric scales from not present to as bad as you can imagine. Patients also rate the amount of interference with daily activities caused by symptoms on 0-10 numeric scales from did not interfere to interfered completely."|Survey and blood draw done within 24 hours of patient's Emergency Center visit|Study terminated early due to low recruitment, insufficient data for analysis.||||||
2802924|NCT00504894|Primary|New Encoding (Scanner) Task Reaction Time (ms)|The encoding task was performed in the scanner. Subjects viewed a pseudorandom sequence of 160 images, made up of the 40 negative-arousing targets and 40 neutral targets, each presented twice (mean interval between first and second presentations 9.1 images). The task was to indicate with the buttonpress device whether the image they were seeing was being presented for the first time ('new') or whether it had been presented earlier in the sequence ('old'). The sequence was divided into eight blocks of 20 images, with a short break in between blocks. The interstimulus interval was jittered to an average of 12 s (range 6-18 s). Images were presented for 3000 ms and separated by a white fixation cross. For counterbalancing, four versions of the sequence were randomly assigned. The entire encoding task took ∼35 min, after which the drug was stopped and the subject removed from the scanner.|for 90 minutes after the drug/placebo was commenced||||ms||Standard Error|Mean
2802925|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802926|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Overall Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802941|NCT00504881|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
2808321|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to Month 9|Intent to treat population of participants who had a cytogenetic response|||treatment cycles||Full Range|Median
2802927|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802928|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Emotional Well-being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802929|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802930|NCT00504881|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The Investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Evaluable subjects are subjects for whom the GES was completed by the investigator at last treatment period visit."|||units on a scale||Standard Deviation|Mean
2802931|NCT00504881|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7= Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to last visit or early discontinuation visit in the 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Evaluable subjects are subjects who completed the GES at last treatment period visit."|||units on a scale||Standard Deviation|Mean
2802932|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression.The HADS was developed as a self-administered scale to assess the presence and severity of Anxiety and Depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802933|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate Anxiety and Depression. The HADS was developed as a self-administered scale to assess the presence and severity of Anxiety and Depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 (higher scores indicating greater problems). A negative value in change from Baseline indicates an improvement from Baseline.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the HADS. Only subjects having values at baseline ans at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802934|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802935|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802936|NCT00504881|Secondary|Change From Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P contains 7 items asking the subjects to rate the degree of 'distress' related to the topic of each subscale (ie, distress items). The QOLIE-31-P also contains an item asking about the relative importance of each subscale topic (ie, prioritization item). The subscale scores, the total score and the Health Status item score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function.|Baseline to 16-week Treatment Period|"Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.~Only subjects who are not mentally impaired were to complete the QOLIE-31-P. Only subjects having values at baseline and at the considered visit are included."|||units on a scale||Standard Deviation|Mean
2802937|NCT00504881|Secondary|Time to Tenth Type I Seizure During Treatment Period|Time to tenth Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
2802938|NCT00504881|Secondary|Time to Fifth Type I Seizure During the 16-week Treatment Period|Time to fifth Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
2802939|NCT00504881|Secondary|Time to First Type I Seizure During the 16-week Treatment Period|Time to first Type I seizure during the 16-week Treatment Period was measured in days.|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
2802940|NCT00504881|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|Baseline to 16-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."|||percentage of participants|||Number
2802942|NCT00504881|Secondary|Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 16-week Treatment Period|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
2802943|NCT00504881|Secondary|Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~A negative value in percent Change from Baseline indicates an improvement from Baseline.~The higher the negative values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline (Week 0) to end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
2802944|NCT00504881|Secondary|Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period|"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||number of seizures per week||Inter-Quartile Range|Median
2802945|NCT00504881|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period|The responder rate was presented as the percentage of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in Partial Onset Seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline (Week 0) to the end of Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
2802946|NCT00504881|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline (Week 0) to the end of the Treatment Period (Week 16)|Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication.|||seizures per week||Inter-Quartile Range|Median
2802947|NCT00504881|Primary|Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Week 2 to the end of the Treatment Period (Week 16)|The Safety Population was defined as all randomized subjects who received at least 1 dose of study medication.|||percentage of participants|||Number
2802948|NCT00504829|Secondary|Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy|Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy|baseline (week 0) to 12 weeks|Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment|||percent change from baseline||Standard Deviation|Mean
2802949|NCT00504829|Primary|Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy|Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.|baseline(randomization) to 12 weeks|Modified intent-to-treat population consisted of all subjects randomized who had at least one dose of study drug and one post-baseline (randomization) assessment|||percent change from baseline||Standard Deviation|Mean
2802950|NCT00504777|Secondary|Change From Baseline in HAQ-DI Score|"The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 as moderate to severe disability, and 2 to 3 as severe to very severe disability."|Week 24|ITT Population|||scores on a scale||Standard Deviation|Mean
2802966|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.|Day 28||||percent change of Endogenous FX activity||Standard Deviation|Mean
2802967|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.|Day 28||||IU/mL||Standard Deviation|Mean
2802968|NCT00504556|Secondary|Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of AUCss|3 months||||ng*h/mL||Full Range|Median
2802951|NCT00504777|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population|||percentage of participants|||Number
2802952|NCT00504777|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Response|ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 24|ITT Population|||percentage of participants|||Number
2802953|NCT00504777|Primary|Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.|Week 24|ITT Population|||scores on a scale||Standard Deviation|Mean
2802954|NCT00504751|Primary|Complete Response|Complete Response|26 months||||participants|||Number
2802955|NCT00504725|Secondary|Verbal Pain Scores|Pain scores rated by the subject on a scale of 0 low - 10 high|baseline, 4 hours, 24 hours and at discharge||||units on a scale||Standard Deviation|Mean
2802956|NCT00504725|Secondary|C-reactive Protein (CRP) Serum Levels|The CRP levels were measured 24 hours postoperatively.|24 hours||||pg/ml||Standard Deviation|Mean
2802957|NCT00504725|Primary|Interleukin Levels at 24 Hours||24 Hours||||pg/ml||Standard Deviation|Mean
2802958|NCT00504660|Primary|6 Month Progression-free Survival for Participants With Glioblastoma|Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.|6 months||||percentage of participants|||Number
2802959|NCT00504660|Primary|12 Month-progression-free Survival for Participants With Anaplastic Tumors|Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.|12 months|Results from TMZ and CCNU treatment arms (Anaplastic Tumor-Glioma Arms 1 & 2) were combined in the final analysis because there was no statistically significant difference between them.|||percentage of participants|||Number
2802960|NCT00504595|Secondary|Efficacy of ACZ885 (Canakinumab) by Assessing the Response to Treatment Using the Disease Activity Score (DAS28)|DAS28 is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). DAS28 measures the C-reactive protein (CRP) (in mg/L) and the patient's general health (GH). GH is measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. DAS28 = 0.56*√(tender28) + 0.28*√(swollen28) + 0.36*log_e(CRP+1) + 0.014*PGDA + 0.96. Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.|||Scores on a scale||Standard Deviation|Mean
2802961|NCT00504595|Secondary|Efficacy of ACZ885 by Assessing the Response to Treatment Using the Simple Disease Index (SDAI)|SDAI is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). SDAI measures the high sensitivity C-reactive protein (hsCRP) level, patient's global disease activity (PGDA) and evaluator's global disease activity (EGDA). PGDA and EGDA are measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. SDAI = tender28 + swollen28 + CRP + (PGDA/10) + (EGDA/10). Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.|||Scores on a scale||Standard Deviation|Mean
2802962|NCT00504595|Primary|Response to Treatment (ACR20) in Adult Patients With Established Rheumatoid Arthritis (RA)|"At each post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures::~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.|||Participants|||Number
2802963|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.|Day 28||||ratio||Standard Deviation|Mean
2802964|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.|Day 28||||seconds||Standard Deviation|Mean
2802965|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b|"Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.~PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition."|Day 28||||seconds||Standard Deviation|Mean
2802978|NCT00504348|Secondary|Progression-free Survival|Patients were considered to have reached the progression if they died, or if they met all the following criteria; (1) ≥10% decline from baseline FVC or ≥15mmHg increase in baseline resting P(A-a)O2, (2) a worsening of interstitial pneumonitis findings by chest CT compared to the most recent study, confirmed by a radiologist, and (3) exclusion of pneumocystis pneumonia, cytomegalovirus pneumonia, and other pulmonary infection on clinical ground.|52 weeks||||percentage of participants||95% Confidence Interval|Number
2802979|NCT00504348|Primary|Overall Survival|Overall survival (OS) was calculated from the day on which the protocol treatment was started until death due to any cause. Participants still alive were censored at the date they were last known to be alive.|52 weeks||||percentage of participants||95% Confidence Interval|Number
2802980|NCT00504309|Secondary|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)|"Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).~HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405.~QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))."|8 weeks||||index units||Standard Error|Mean
2802981|NCT00504309|Secondary|Fasting Insulin|Effect of P-OM3 dose on fasting insulin|8 weeks||||μIU/mL||Standard Error|Mean
2802982|NCT00504309|Secondary|C-reactive Protein (CRP)|Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP|8 weeks||||mg/L||Standard Error|Mean
2802983|NCT00504309|Secondary|Psychosocial Profile Questionnaires|"Effect of P-OM3 dose on psychosocial questionnaires:~Perceived Stress Scale (PSS)~14 questions, scored 0-4 based on how often the subject felt certain emotions~Scores: 0 to 40; higher scores indicate higher perceived stress~Spielberger State Anxiety Inventory~Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale~Scores: 20 to 80; higher scores indicate higher levels of anxiety~Positive and Negative Affect Scales (PANAS)~Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much).~Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect~Center for Epidemiologic Studies Depression (CES-D) Scale~20 questions about symptoms of depression in the past week~Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional"|8 weeks||||scores on a scale||Standard Error|Mean
2802984|NCT00504309|Secondary|Fasting Glucose|Effect of P-OM3 dose on fasting glucose|8 weeks||||mg/dL||Standard Error|Mean
2802985|NCT00504309|Secondary|Cytokine Inflammatory Markers|Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma|8 weeks||||pg/mL||Standard Error|Mean
2802986|NCT00504309|Secondary|Erythrocyte Fatty Acids|Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells|8 weeks||||percentage||Standard Error|Mean
2802987|NCT00504309|Primary|Heart Rate|Effect of P-OM3 dose on heart rate|8 weeks||||beats per minute||Standard Error|Mean
2802988|NCT00504309|Primary|Blood Pressure|Effect of P-OM3 dose on blood pressure|8 weeks|Two participants did not complete the study and were therefore excluded from analysis.|||mm Hg||Standard Error|Mean
2802989|NCT00504309|Primary|Flow-mediated Dilation (FMD)|Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.|8 weeks||||% change in brachial artery diameter||Standard Error|Mean
2802990|NCT00504309|Primary|Lipid Profile|Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.|8 weeks||||mg/dL||Standard Error|Mean
2802991|NCT00504257|Secondary|Overall Survival (OS)|Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.|Up to 5 years|All evaluable participants|||months||95% Confidence Interval|Median
2802992|NCT00504257|Secondary|Occurrence of Grade 3 or 4 Toxicity|Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 4 years|All evaluable participants|||participants|||Number
2802993|NCT00504257|Secondary|Overall Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.|Up to 5 years|Response Rate (RR) evaluable patients included all patients who received at least 2 cycles of treatment and at least one tumor assessment or had demonstrated clinical progression.|||participants|||Number
2802994|NCT00504257|Secondary|Median Progression Free Survival|"PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|Up to 5 years|All evaluable participants|||months||95% Confidence Interval|Median
2802995|NCT00504257|Primary|Six Month Progression Free Survival (PFS)|"Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|6 months per participant|All evaluable participants|||percentage of participants||95% Confidence Interval|Number
2802996|NCT00504231|Secondary|Assessment of Reactogenicity|Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment|1 week||||participants|||Number
2802997|NCT00504231|Secondary|Geometric Mean Titer (GMT) Pre- and Post- Vaccination|GMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month||||GMT||95% Confidence Interval|Geometric Mean
2802998|NCT00504231|Primary|Seroprotection Pre- and Post- Vaccination|Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month||||% of Participants|||Number
2802999|NCT00504166|Primary|Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT|Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone.|Baseline, 24 months|final statistical analysis was performed per protocol|||Percent change||Standard Deviation|Mean
2803000|NCT00504153|Secondary|Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days|Changes of VEGF will be correlated with response rates and 4-month progression-free survival utilizing the Wilcoxon rank-sum test.|At baseline and day 15|This outcome was not assessed for any of the patients.||||||
2803001|NCT00504153|Secondary|Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response|Examined by comparing expression in those who have an objective response versus those who do not and in those with and without disease progression at 4 months using Fisher's exact test.|4 months|This outcome was not assessed for any of the patients.||||||
2803002|NCT00504153|Secondary|Incidence of Somatic Mutations|Multivariable analysis of progression-free survival duration will be performed using the Cox (1972) regression model to evaluate the prognostic value of somatic mutations. For the mutational analysis endpoints, genetic mutations will also be correlated with drug activity via Fisher's exact test for comparisons of responders with non-responders and for comparison of patients progression-free and 4 months vs. those with early progression or death|1 year|This outcome was not assessed for any of the patients.||||||
2803003|NCT00504153|Secondary|Response Rate (RR) (Complete or Partial Responders)|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. The response rate is the proportion of subjects who experienced a complete or partial response.|Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months)||||percentage of participants|||Number
2803004|NCT00504153|Primary|Progression-free Survival Rate|Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months.|From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)||||percentage of participants|||Number
2803005|NCT00504075|Secondary|Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.|Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.|Days 1, 2, 3, 5, 9, 14, 21, 32.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.|||days||95% Confidence Interval|Median
2803006|NCT00504075|Secondary|The Safety of GAMMAPLEX at the Dosage Used in This Study.|"The safety variables used to assess safety were the following:~Adverse events~The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops~Nature, severity, and frequency of AEs~Suspected unexpected serious adverse reactions (SUSARs)~Vital signs~Clinical laboratory tests and Direct Coombs' Test~Transmission of viruses~Physical examination"|AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.|||% of subjects with product related SAEs||95% Confidence Interval|Number
2803007|NCT00504075|Primary|The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.|The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.|9 days|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.|||participants|||Number
2803008|NCT00504023|Primary|Percentage of Participants With Clinical and Histologic Remission|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|12 weeks post treatment||||% of participants|||Number
2803009|NCT00503997|Primary|Patient Response to Treatment Measured by RECIST Criteria|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 8 weeks||||participants|||Number
2803010|NCT00503984|Secondary|Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.||Up to 4.5 years|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.|||participants|||Number
2803011|NCT00503984|Secondary|Overall Survival (OS)|The time from the date of initiation of study treatment until date of death from any cause.|Up to 4.5 years.||||months||95% Confidence Interval|Median
2803012|NCT00503984|Secondary|Progression-Free Survival (PFS)|The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier.|Up to 4.5 years||||months||95% Confidence Interval|Median
2803013|NCT00503984|Secondary|Duration of Response|Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|The 10 participants in both Phase 1 and Phase 2 who achieved PSA response.|||weeks||Full Range|Median
2803014|NCT00503984|Primary|Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.|"Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; "|Up to 4.5 years|Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan.|||participants|||Number
2803015|NCT00503984|Primary|Number of Participants Achieving Prostate-specific Antigen (PSA) Response.|Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy.|||participants|||Number
2803016|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.|||mg|||Number
2803017|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.|||mg/m2|||Number
2803018|NCT00503906|Post-Hoc|Rate of Overall Survival in Study Participants|Rate of overall survival in study participants. Overall survival will be measured from the date of enrollment to the date of death from any cause, or the date of last contact (censored observations.)|18 months||||percentage of participants||95% Confidence Interval|Median
2803019|NCT00503906|Secondary|Relationship Between SPARC Expression and Response to Protocol Therapy.|Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.|Baseline, over the course of treatment, about 1 year|Data were not collected for this outcome measure.||||||
2803020|NCT00503906|Secondary|Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment|Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.|Baseline, over the course of Treatment, about 1 year|Data were not collected for this outcome measure.||||||
2803021|NCT00503906|Secondary|Rate of Toxicity in Study Participants|Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Over the course of study treatment.||||percentage of participants|||Number
2803022|NCT00503906|Secondary|Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants|Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|After two cycles, about 60 days|Evaluable patients are study-eligible patients who receive an initial infusion of combination chemotherapy consisting of Gemcitabine, NAB paclitaxel and Bevacizumab and have had at least one CT scan for evaluation of disease status.|||percentage of participants|||Number
2803023|NCT00503906|Primary|Median Progression-Free Survival|Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.|Up to 24 months||||months||95% Confidence Interval|Median
2803024|NCT00503880|Secondary|Changes in Flow of Cytometric Patterns.|To assess changes in flow cytometric patterns.|7 months|||||||
2803025|NCT00503880|Secondary|Cytogenetic Response Rates|To assess cytogenetic response rates.|7 months|||||||
2803026|NCT00503880|Secondary|Time to Acute Myelooid Leukemia Transformation or Death.|To assess the time to acute myeloid leukemia transformation or death.|7months|||||||
2803027|NCT00503880|Secondary|Quality of Life|To assess effects on quality of life of this patient population.|7 months|||||||
2803028|NCT00503880|Primary|Presence of Hematologic Response (Phase II)|"These are measured in patients with pretreatment abnormalities defined as:~Hemoglobin < 11 g/dL or transfusion dependence [erythroid- E] Platelets less than 100 x 109/L or platelet-transfusion dependence [platelet- P] Absolute neutrophil count (ANC) less than 1.0 x 109/L [neutrophil- N] Pretreatment baseline measures of cytopenias are averages of at least 2 measurements (not influenced by transfusions)- at least 1 week apart."|Following phase I, responses must last at least 8 weeks.|The study only enrolled 2 patients of the planned 30. The two patients enrolled did not complete the research as planned and were not evaluable. The study was closed due to lack of funding support. Data were not collected.||||||
2803777|NCT00496782|Secondary|Change in Lymphocyte Subset CD8 From Day 1|Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1|Day 1(Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803029|NCT00503880|Primary|Maximum Tolerated Dose of Clofarabine (Phase I)|Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 2 out of 6 patients experience dose limiting toxicities or the highest dose cohort, if 2 limiting toxicities are not observed at any dose cohort. These will be presented as actual rates. Dose limiting toxicity (DLT) will be defined according to oncology standards based on NCI CTC version 2 grading criteria (DLT = > grade 3 non-hematological toxicity or any > 4 hematological toxicity that persists for more than 4 weeks and in the opinion of the investigator is felt not to be due to disease).|7 months|||||||
2803030|NCT00503841|Secondary|Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride||At day -7, prior to surgery, and 1 week post-surgery|No data collected for secondary hypotheses.||||||
2803031|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)||Baseline and day 0|No data collected for secondary hypotheses.||||||
2803032|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer||Baseline and day 0|No data collected for secondary hypotheses.||||||
2803033|NCT00503841|Primary|Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer||Baseline and day 0|No participants received the study drug erlotinib hydrochloride.||||||
2803034|NCT00503776|Secondary|Changes in the Frequency and Types of Dietary Intakes|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation|Due to loss of funding, sufficient data for analysis was not collected.||||||
2803035|NCT00503776|Secondary|Changes in the Amount and Texture of Food Consumed|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation|Due to loss of funding, sufficient data for analysis was not collected.||||||
2803036|NCT00503776|Secondary|Number of Patients With Oral Mucositis by Grade|Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).|6 months after concurrent chemotherapy and radiation|Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).|||participants|||Number
2803037|NCT00503776|Secondary|Stimulated and Unstimulated Salivary Production|Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.|6 months after concurrent chemotherapy and radiation|Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2)|||mL per minute||Standard Deviation|Mean
2803038|NCT00503776|Primary|Number of Patients With Each Degree of Swallowing Dysfunction|Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment|6 months after concurrent chemotherapy and radiation|One patient (Arm 2B) did not undergo the 6-month study|||participants|||Number
2803039|NCT00503750|Secondary|Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.|"Complete clinical response (CCR): complete disappearance of all measurable malignant disease. No new malignant lesion, disease-related symptoms or evidence of non-evaluable disease.~Partial response (PR): Reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.~Stable disease (SD): For bidimensionally measurable disease, no decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions."|clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op||||participants|||Number
2803040|NCT00503750|Primary|Number of Participants With Complete Pathologic Response.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.~Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response."|assess at 8 weeks||||participants|||Number
2803041|NCT00503698|Secondary|Health Related Quality of Life Assessments|Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Observations from end of trial visit is substitute for week 104. Not all subjects provided 'quality of life' data.|||scores on a scale||Standard Deviation|Mean
2803042|NCT00503698|Secondary|Mortality - Two-year Mortality Rate||week 0, trial termination|No analysis was done since the trial was prematurely terminated before week 104 of the trial. Trial was terminated January 16th, 2009.||||||
2803043|NCT00503698|Secondary|Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures|The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).|||hospitalisations||Standard Deviation|Mean
2803087|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)|Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population|||mL/min||Standard Deviation|Mean
2803044|NCT00503698|Secondary|Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)|Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 (end of trial per protocol).|||percentage of participants|||Number
2803045|NCT00503698|Primary|Mortality - Time to All-cause Death|Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).|||percentage of participants|||Number
2803046|NCT00503685|Secondary|Expression of IGF Binding Proteins (IGFBP2, IGFBP3)||Randomization/treatment up to 26.9 months|Zero participants analyzed. No data collected for analysis.||||||
2803047|NCT00503685|Secondary|Expression of Type I Insulin-Like Growth Factor Receptors (IGF-IR)||Randomization/treatment up to 26.9 months|Zero participants analyzed. No data collected for analysis.||||||
2803048|NCT00503685|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR, Response Rate) in Participants With Kirsten Rat Sarcoma (K-ras) Mutations|The response rate in participants with K-ras mutations was not collected for analysis.|Treatment up to 26.9 months|Zero participants analyzed. Response rate data was not collected for analysis due to N=0 CR and N=1 PR.||||||
2803049|NCT00503685|Secondary|Area Under Serum Concentration (AUC)||Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)|Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.||||||
2803050|NCT00503685|Secondary|Minimum Concentration (Cmin)||Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)|Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.||||||
2803051|NCT00503685|Secondary|Maximum Concentration (Cmax)||Week 1 (Initial dose), Week 3 (Dose 2), Week 5 (Dose 3), Week 7 (Dose 4), Week 9 (Dose 5), and Week 11 (Dose 6)|Zero participants analyzed. PK data was not collected for analysis due to the low number of participants in PK.||||||
2803052|NCT00503685|Secondary|Number of Participants Reporting Treatment-Emergent Severe Adverse Events|Data presented are the number of participants who experienced serious adverse events (SAEs) or death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Randomization/treatment up to 26.9 months|All randomized/enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2803053|NCT00503685|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|Data presented are the number of participants who experienced nonserious adverse events (AEs) during the study including the 30-day follow-up. A summary of serious AEs (SAEs) and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Randomization/treatment up to 26.9 months|All randomized/enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2803054|NCT00503685|Secondary|Duration of Overall Response|The duration of overall response (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of PD or death due to any cause. CR, PR and PD were determined using RECIST criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of overall response was censored at their last tumor assessment prior to the cutoff date. Duration of overall response was not analyzed due to low number of participants with CR or PR.|Time of response to time of measured PD or death up to 161 days|Zero participants analyzed. Duration of Response for CR or PR data was not collected for analysis due to N=0 CR and N=1 PR.||||||
2803055|NCT00503685|Secondary|Duration of Stable Disease (SD)|The duration of SD is measured from the date of randomization/treatment until the date of PD. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. RECIST criteria version 1.0 was used to asses PR and PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants who had no PD or death at the time of the data inclusion cutoff, duration of SD was censored at their last tumor assessment prior to the cutoff date.|Time from randomization/treatment to first date of PD up to 28.3 weeks|All randomized/enrolled participants who received at least 1 dose of the study drug and achieved SD or better. The number of participants censored was 0 for IMC-A12 group, 0 for IMC-A12 + cetuximab group and 1 for IMC-A12 + cetuximab (K-ras wild-type) group.|||weeks||95% Confidence Interval|Median
2803056|NCT00503685|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of randomization/treatment to the date of death from any cause. Participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.|Randomization/treatment to date of death from any cause up to 26.9 months|All randomized/enrolled participants who received at least 1 dose of study drug. The number of participants censored was 5 for IMC-A12 group, 4 for IMC-A12 + cetuximab group and 11 for IMC-A12 + cetuximab (K-ras wild-type) group.|||months||95% Confidence Interval|Median
2804039|NCT00495391|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment||||participants|||Number
2803057|NCT00503685|Secondary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of randomization/treatment to the date of PD or death from any cause. PD was determined using RECIST criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the cutoff date. Participants who began a new antitumor treatment before evidence of PD were categorized as PD.|Randomization/treatment to measured PD up to 28.3 weeks|All randomized/enrolled participants who received at least 1 dose of study drug. The number of participants censored was 0 for IMC-A12 group, 1 for IMC-A12 + cetuximab group and 1 for IMC-A12 + cetuximab (K-ras wild-type) group.|||weeks||95% Confidence Interval|Median
2803058|NCT00503685|Primary|Percentage of Participants With Complete Response (CR) or Partial Response [PR, Objective Response Rate (ORR)]|ORR is the percentage of participants with a confirmed CR or PR, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from start of the treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|Start of randomization/treatment to date of objective progressive disease (PD) up to 28.3 weeks|All randomized/enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2803059|NCT00503425|Secondary|Change From Baseline in Bone Density Score at Weeks 48 and 104|Bone density or bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD test results are compared to the ideal or peak BMD of a healthy 30-year-old adult, and results are provided as T-score. A score of 0 means BMD is equal to the norm for a healthy young adult. Differences between observed BMD and that of the healthy young adult norm are measured in units called standard deviations (SDs). The more standard deviations below 0, indicated as negative numbers, lower the BMD higher the risk of fracture. SD + 1 to -1 indicates normal BMD; SD between -1 to -2.5 indicates low bone mass, SD -2.5 or lower indicates osteoporosis. Change in bone density was measured in participants who were not treated with biphosphonates by Dual Energy X-Ray Absorptiometry. Change in bone density was assessed at baseline and at Weeks 48 and 104. Change from baseline in bone density score was reported for all 5 courses.|Baseline, Weeks 48 and 104 (End of treatment)|ITT population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||T-score||Standard Deviation|Mean
2803060|NCT00503425|Secondary|Percentage of Participants With EULAR DAS 28 Response at Week 24|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Week 24. EULAR response was based on change from baseline (COB) in DAS28 score and also on actual DAS28 score, at Week 24. DAS28 score= participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: 0.56*√TJC+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score=0-10, higher scores represented higher disease activity. Scores below 2.6: clinical remission, </=3.2: low disease activity, </=5.1: moderate disease activity, above 5.1: severe disease. EULAR Good response: DAS28</=3.2; COB<-1.2. Moderate response: DAS28</=3.2 or >3.2 to </=5.1 or >5.1; COB <-1.2 or <-0.6 to greater than or equal to (>/=)-1.2. No response: DAS28 </=3.2 or > 3.2 to </=5.1 or >5.1; COB <-0.6 to >/=-1.2 or >/=-0.6. EULAR response was reported for 5 courses.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||Percentage of participants|||Number
2803061|NCT00503425|Secondary|Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24|DAS28 score is a measure of participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated according to following formula: [0.56*√TJC] + [0.28*√SJC] + [0.70*ln ESR] + [0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of </= 3.2 indicated low disease activity, score of </= 5.1 indicated moderate disease activity, and scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses. Participants whose DAS28 score improved by 1.2 score were reported.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||Percentage of participants|||Number
2803062|NCT00503425|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24|DAS28 score is a measure of participant's disease activity calculated using tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: 0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses.|Baseline, Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.|||Units on a scale||Standard Deviation|Mean
2803063|NCT00503425|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of SAEs.|Baseline up to study withdrawal or follow-up (Approximately 104 weeks)|Safety population included all participants who had received any part of an infusion of study medication.|||Participants|||Number
2803064|NCT00503399|Secondary|Number of Participants With Adverse Events (AEs)|Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]).|Baseline up to 18 months|The safety analysis set included all participants who received study treatment.|||participants|||Number
2803065|NCT00503399|Secondary|Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months|β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.|3, 6, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||nanograms per deciliter (ng/dL)||Standard Error|Least Squares Mean
2803066|NCT00503399|Secondary|Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months|P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.|Baseline, 3 months, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||micrograms per deciliter (μg/dL)||Standard Error|Least Squares Mean
2803067|NCT00503399|Secondary|Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months|Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.|Baseline, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
2803068|NCT00503399|Secondary|Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||Newton per millimeter (N/mm)||Standard Error|Least Squares Mean
2803069|NCT00503399|Secondary|Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||Newton/millimeter/radian (N/mm/rad)||Standard Error|Least Squares Mean
2803070|NCT00503399|Secondary|Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months|Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.|||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
2803071|NCT00503399|Secondary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months|Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.|||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
2803072|NCT00503399|Primary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months|Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 18 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.|||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
2803088|NCT00503113|Secondary|Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)|Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population|||mL/min||Standard Deviation|Mean
2804040|NCT00495391|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment||||participants|||Number
2803073|NCT00503308|Primary|Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)|We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).|same day as HIV test counseling (cross-sectional study)||||scores on scale||95% Confidence Interval|Mean
2803074|NCT00503139|Secondary|European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)|DAS28-3 (ESR) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count and ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (3/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants||95% Confidence Interval|Number
2803075|NCT00503139|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom VAS Fatigue was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||Score||Standard Deviation|Mean
2803076|NCT00503139|Secondary|Modified Health Assessment Questionnaire (mHAQ) Score|Modified Health Assessment Questionnaire-(mHAQ): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom mHAQ was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||Score||Standard Deviation|Mean
2803077|NCT00503139|Primary|European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|2 years|The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (4/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants||95% Confidence Interval|Number
2803078|NCT00503139|Primary|Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
2803079|NCT00503139|Primary|Number of Participants With Serious Treatment Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
2803080|NCT00503139|Primary|Number of Participants With Treatment Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
2803081|NCT00503139|Primary|Number of Participants in Safety Analysis Population of Etanercept||3 years|The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.|||Participants|||Number
2803082|NCT00503113|Secondary|Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.|The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.|Baseline and 9 months|PP Population|||mg/g||Standard Deviation|Mean
2803083|NCT00503113|Secondary|Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.||Baseline and 9 months|PP Population|||mg/g||Standard Deviation|Mean
2803084|NCT00503113|Secondary|Relative Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population|||mg/dL||Standard Deviation|Mean
2803085|NCT00503113|Secondary|Absolute Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population|||mg/dL||Standard Deviation|Mean
2803086|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using CG Formula)|Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population|||mL/min||Standard Deviation|Mean
2803089|NCT00503113|Primary|Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)|The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|Per Protocol (PP) Population|||mL/min||Standard Deviation|Mean
2803090|NCT00503009|Secondary|Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4|eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
2803091|NCT00503009|Secondary|Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4|FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
2803092|NCT00503009|Secondary|Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4|PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
2803093|NCT00503009|Primary|Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4|The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4|||||||
2803094|NCT00502996|Secondary|Mean Value of Inflamed Joints|The efficacy of rituximab was assessed by evaluating inflamed joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||number of inflamed joints||Standard Deviation|Mean
2803095|NCT00502996|Secondary|Mean Values of Pain and Activity Based on Visual Analogue Scale|Pain assessment was assessed by using a VAS (0=no pain to 100=unbearable pain). Disease activity was also evaluated by participants and investigators by using a VAS (0=no disease activity to 100=maximum disease activity).|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||Scores on scale||Standard Deviation|Mean
2803096|NCT00502996|Secondary|Mean Values of Globular Sedimentation Velocity|Globular sedimentation velocity is a component of ACR.|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||millimeters per hour||Standard Deviation|Mean
2803097|NCT00502996|Secondary|Mean Values of C Reactive Protein|C Reactive Protein (CRP) is a component of ACR. CRP is a marker of inflammation.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||milligrams per liter||Standard Deviation|Mean
2803098|NCT00502996|Secondary|Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index)|Health Assessment Questionnaire - Disease Index (HAQ-DI) indicates how the disease affected participant's activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Screening (Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||Scores on scale||Standard Deviation|Mean
2803099|NCT00502996|Secondary|Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria|American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender joints and swollen joints, as well as for three of the additional five ACR core set variables: patient's assessment of pain using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain); patient's global assessment of disease activity and physician's global assessment of disease activity using a VAS (0=no disease activity to 100=maximum disease activity); health assessment questionnaire (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant; C-reactive protein and globular sedimentation velocity.|Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||participants|||Number
2803100|NCT00502996|Secondary|Mean Value of Painful Joints|The efficacy of rituximab was assessed by evaluating painful joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||number of painful joints||Standard Deviation|Mean
2803101|NCT00502996|Secondary|Mean Duration of Morning Joint Stiffness|The efficacy of rituximab was assessed by evaluating mean duration of morning joint stiffness.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.|||Minutes||Standard Deviation|Mean
2803102|NCT00502996|Secondary|Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit|The mean aspartate transaminase (AST) and alanine transaminase (ALT), Alkaline phosphatase (AP), and Lactic dehydrogenase (LDH) concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||International units/liter||Standard Deviation|Mean
2803103|NCT00502996|Secondary|Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit|The mean concentration of potassium, chlorine, sodium and phosphorus for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||millimoles per liter||Standard Deviation|Mean
2803104|NCT00502996|Secondary|Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.|The mean concentration of cholesterol, uric acid, urea, creatinine, calcium, total bilirubin and serum total proteins (STP) for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||mg/dL||Standard Deviation|Mean
2803105|NCT00502996|Secondary|Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)|The mean albumin and glucose concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||g/dL||Standard Deviation|Mean
2803106|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)|The mean leucocytes and platelets concentration for each participant was estimated at Screening, at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||10^9 cells/liter||Standard Deviation|Mean
2803107|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)|The mean erythrocyte concentration for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||10^12 cells/liter||Standard Deviation|Mean
2803108|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant was estimated at Screening and EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The analysis was performed on safety population. Eligible participants who received one treatment dose of Rituximab, have completed the follow-up period, Visit 11, and end of follow-up period in safety conditions and also who had been withdrawn or not from the study were included in the safety population.|||femtoliters||Standard Deviation|Mean
2803109|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)|The hematology parameters (hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for each participant were estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||percentage of cells||Standard Deviation|Mean
2803110|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)|The values of hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) for each participant were estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||g/deciliter (dL)||Standard Deviation|Mean
2803111|NCT00502996|Primary|Number of Participants With AEs of Special Interest During the Study|Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
2803112|NCT00502996|Primary|Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs|"An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification Yes and No. A relationship classified as Yes implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments."|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
2803113|NCT00502996|Primary|Number of Participants With AEs According to Degree of Intensity|An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
2803171|NCT00502775|Secondary|Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & three in the FFNS group recorded no data during the two-week treatment period.|||Score on a Scale||Standard Error|Mean
2803114|NCT00502996|Primary|Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death|An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.|||participants|||Number
2803115|NCT00502944|Primary|Linkage to Care of Newly Diagnosed HIV Infected Participants|We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level.|Assessed within 8 weeks after receipt of reactive rapid HIV test results|DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed.|||participants|||Number
2803116|NCT00502944|Other Pre-specified|Test Acceptance Rate|Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.|Assess on day subject enrolled into the study|Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test.|||participants|||Number
2803117|NCT00502944|Other Pre-specified|Test Offer Rate|The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.|Assess on day subject enrolled into the study||||participants|||Number
2803118|NCT00502944|Secondary|Overall Rapid HIV Testing Rate|We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm.|Assess on day subject enrolled into the study|Intention to treat analysis|||participants|||Number
2803119|NCT00502905|Primary|Number of Participants With Successful Engraftment|Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.|Study period one week prior to transplant through post Day 28|Analysis per protocol.|||participants|||Number
2803120|NCT00502853|Secondary|X-Rays: Left Hand Total Score|Left hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2803121|NCT00502853|Secondary|X-Rays: Right Hand Total Score|Right hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and scores ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2803122|NCT00502853|Secondary|Joint Space Narrowing - Left Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 x 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2803123|NCT00502853|Secondary|Joint Space Narrowing - Right Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 times [x] 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.|||units on a scale||Standard Deviation|Mean
2803124|NCT00502853|Secondary|Erosion Score - Left Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population; n=number of participants with values for analysis at the specified timepoints.|||units on a scale||Standard Deviation|Mean
2803125|NCT00502853|Secondary|Erosion Score - Right Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population|||units on a scale||Standard Deviation|Mean
2803126|NCT00502853|Secondary|Percentage of Total B-lymphocytes|Concentration of all B-lymphocytes subtypes was assessed.|Baseline and Weeks 4, 12, and 24|Safety Population|||percentage of cells||Standard Deviation|Mean
2803127|NCT00502853|Secondary|Hematocrit Concentration (%)||Baseline and Weeks 4, 12, and 24|Safety Population|||percentage||Standard Deviation|Mean
2803128|NCT00502853|Secondary|Total Immunoglobulin (Ig) Concentrations|Total Ig concentrations as measured by milligrams per milliliter (mg/mL).|Baseline and Weeks 4, 12, and 24|Safety Population|||mg/mL||Standard Deviation|Mean
2803129|NCT00502853|Secondary|Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations|RF IgM concentrations measured by international units per milliliter (IU/mL). RF is an antibody reacting against the fragment, crystallizable (Fc) region of IgG. Quantitative measurements have shown a prognostic value in distinguishing between progressive and non-progressive disease in early RA, a correlation with radiologically determined joint damage, and relation with clinical improvement after disease-modifying anti-rheumatic treatment.|Baseline and Weeks 4, 12, and 24|Safety Population|||IU/mL||Standard Deviation|Mean
2803130|NCT00502853|Secondary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count|Anti-CCP autoantibodies count measured by units per milliliter (U/mL). The anti-CCP autoantibodies bind antigenic determinants that contain the unusual amino acid citrulline. The anti-CCP antibody is a highly specific diagnostic test of RA (though with variable sensitivity) and a marker of joint damage with high prognostic significance.|Baseline and Weeks 4, 12, and 24|Safety Population|||U/mL||Standard Deviation|Mean
2803131|NCT00502853|Secondary|C-Reactive Protein (CRP)|CRP measured by milligrams per deciliter (mg/dL). High levels of CRP are indicators of active inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population|||mg/dL||Standard Deviation|Mean
2803132|NCT00502853|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was determined using the Westergren method. ESR measures how fast red blood cells (erythrocytes) fall to the bottom of a fine glass tube that is filled with the participant's blood. The higher the sedimentation rate the greater the inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population|||mm/hr||Standard Deviation|Mean
2803133|NCT00502853|Secondary|DAS28 Score|DAS28 calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (≤) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 12, and 24|Safety Population|||units on a scale||Standard Deviation|Mean
2803134|NCT00502853|Secondary|Patient's Global Assessment of Pain|"The participant's assessment of their current level of pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line was described as no pain and the right-hand as unbearable pain. The participant was asked to mark the line corresponding to their current level of pain and the distance from the left edge was recorded."|Baseline and Weeks 4, 12, and 24|Safety Population|||mm||Standard Deviation|Mean
2803135|NCT00502853|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis (RA). It consist of 20 items referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item within a domain was scored on a 4-point Likert scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The highest score reported by the participant for a domain determined the score for that domain. The overall disability index is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 4, 12, and 24|Safety Population|||units on a scale||Standard Deviation|Mean
2803136|NCT00502853|Primary|Relative Enhancement (RE) Score|"A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using dynamic MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (REE) and its steady state condition (RE)."|Baseline, Weeks 4 and 24|Safety Population|||percent||Standard Deviation|Mean
2803137|NCT00502853|Primary|Early Enhancement Rate (REE)|"A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using dynamic MRI, i.e. Contrast-Enhanced Dynamic MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (rate of early enhancement - REE) and its steady state condition (relative enhancement - RE). REE per second during the first 55 seconds was calculated according to the formula REE55 = (S55-S0)/(S0x55)x100%. The REE shows the slope of the curve of contrast uptake tangential to the α angle and is steeper if inflammation is higher."|Baseline, Weeks 4 and 24|Safety Population|||percent per second||Standard Deviation|Mean
2803138|NCT00502853|Secondary|Ritchie Articular Index Scores|The Ritchie Articular Index is a graded assessment of tenderness in 26 joint regions. The sum of the grades of tenderness (0=not tender, 1=tender, 2=tender and causes wince, and 3 tender, causes wince and effort to withdraw) elicited by applying firm pressure over the joint margin of articular joints (such as shoulders, elbow, wrists, hips). The scores ranged from 0 (no tenderness) to 78 (most severe tenderness).|Baseline and Weeks 4, 12, and 24|Safety Population|||units on a scale||Standard Deviation|Mean
2803139|NCT00502853|Primary|OMERACT RAMRIS Erosion Score|MRI bone erosion measures a sharply marginated bone lesion, with correct juxta-articular localization and typical signal characteristics, which is visible in 2 planes with a cortical break seen in at least 1 plane. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) scored separately. Scale is 0-10 based on proportion of eroded bone compared to assessed bone volume (0=no erosion; 1=1%-10% of bone eroded; 2=11%-20%, etc). For long bones, assessed bone volume is from articular surface (or best estimated position if absent) to depth of 1 centimeter (cm); in carpal bones it is the whole bone. Total erosion score=sum of individual scores for an overall range of 0-230, where 0=no erosion and 230=most severe erosion. Change in erosion=Follow-up erosion score - baseline score.|Baseline, Week 4, and Week 24|Safety Population|||units on a scale||Standard Deviation|Mean
2803140|NCT00502853|Primary|OMERACT RAMRIS Bone Edema Score|Extension and degree of bone edema in the wrist according to the RAMRIS score developed by OMERACT. Bone edema is a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) is scored separately. The scale of 0-3 was based on the proportion of bone with edema, as follows: 0=no edema; 1=1 percent (%) to 33% of bone was edematous; 2 = 34%-66% of bone was edematous; and 3= 67%-100% of bone was edematous. Total bone edema score=sum of the individual scores for an overall range of 0-69, where 0=no edema and 69=most severe edema. Change in bone edema = follow-up bone edema score - baseline score.|Baseline, Weeks 4 and 24|Safety Population|||units on a scale||Standard Deviation|Mean
2803141|NCT00502853|Primary|Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score|Extension and degree of synovitis in wrist according to RAMRIS score developed by OMERACT. Synovitis is an area in synovial compartment that shows above normal post-gadolinium enhancement of a thickness greater than width of normal synovium. Synovitis is assessed in 3 wrist regions (distal radioulnar joint; radiocarpal joint; intercarpal and carpometacarpal joints) and in each metacarpophalangeal (MCP) joint. 1st carpometacarpal joint and 1st MCP joint are not scored. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score=the sum of the individual scores (3 wrist regions [range 0-9] or 4 MCP joints [range 0-12]) for an overall range of 0-21, where 0=no damage and maximum score [9, 12, or 21]=most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|Baseline, Week 4, and Week 24|The Safety Population included all participants who received any portion of the rituximab dose and was used for efficacy and safety analyses.|||units on a scale||Standard Deviation|Mean
2803142|NCT00502840|Secondary|Rheumatoid Factor (RF)|RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||IU/mL||Standard Deviation|Mean
2803143|NCT00502840|Secondary|Erythrocyte Sedimentation Rate|ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
2803144|NCT00502840|Secondary|C-Reactive Protein|CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2803145|NCT00502840|Secondary|Patient's Assessment of Pain|"Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2803146|NCT00502840|Secondary|Patient's Global Assessment of Disease Activity|"Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2803147|NCT00502840|Secondary|Physician's Global Assessment of Disease Activity|"Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
2803172|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803148|NCT00502840|Secondary|Tender Joint Count|Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
2803149|NCT00502840|Secondary|Swollen Joint Count|Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
2803150|NCT00502840|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course|ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit.|24 weeks after each course|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2803151|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - General Heath Perceptions|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803152|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Vitality|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803153|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Social Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803154|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Well-Being|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803169|NCT00502775|Secondary|Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)|Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.|Baseline, Day 15 or if Early Withdrawal Day|Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.|||Score on a Scale||Standard Error|Mean
2803155|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Role Functioning|SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803156|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Role Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803157|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Bodily Pain|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803158|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803159|NCT00502840|Secondary|SF-36 MCS by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803160|NCT00502840|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803170|NCT00502775|Secondary|Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.|||Score on a Scale||Standard Error|Mean
2804041|NCT00495391|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment||||participants|||Number
2803161|NCT00502840|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course|FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803162|NCT00502840|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course|HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803163|NCT00502840|Secondary|Percentage of Participants Achieving a Response By EULAR Category and Treatment Course|Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2803164|NCT00502840|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2803165|NCT00502840|Secondary|DAS28 Score by Treatment Course and Follow-up (FU) Visit|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2803166|NCT00502840|Primary|Change From Baseline in DAS28 Score at Week 24|DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.|Week 24|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form, received at least 1 dose of study medication, and where the DAS28 was measured at least once under study medication.|||scores on a scale||Standard Deviation|Mean
2803167|NCT00502801|Secondary|Clinical Response Rates at the Late Follow-up Assessment.|"The table below shows the percentage of subjects who had a clinical response of clinical cure at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of clinical cure is defined as no further antibacterial therapy needed for treatment of the infection."|28 to 35 days after last dose of study therapy|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.|||Percentage of participants|||Number
2803168|NCT00502801|Primary|Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.|"The table below shows the percentage of subjects who had a clinical response of clinical cure at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of clinical cure is defined as no further antibacterial therapy needed for treatment of the infection."|5 to 21 days after the last dose of study therapy, or at early termination.|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.|||Percentage of participants||95% Confidence Interval|Number
2803173|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803174|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803175|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803176|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803177|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803178|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803179|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2||||Score on a Scale||Standard Error|Mean
2803180|NCT00502775|Primary|Mean Change From Baseline in the Nighttime Symptom Score (NSS)|Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.|Baseline and Weeks 1-2|One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.|||Score on a Scale||Standard Error|Mean
2803181|NCT00502697|Secondary|Maternal Length of Stay at Delivery|Number of maternal hospital days associated with delivery|Hospital discharge point following delivery|Of the 211 participants, data on length of stay at delivery were available for 194 women. The most common reason for the lack of this information was that the birth did not take place at the study’s medical center.|||days||Full Range|Median
2803182|NCT00502697|Primary|Infant Gestational Age|Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.|Time of delivery|ITT analysis used with all participants that birth information could be obtained.|||weeks||Inter-Quartile Range|Median
2803183|NCT00502671|Secondary|Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.|||percentage of participants|||Number
2803184|NCT00502671|Primary|Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.|||percentage of participants|||Number
2803326|NCT00501293|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 months|ITT|||Units on a scale||Standard Deviation|Mean
2803185|NCT00502593|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn's disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison's disease). skin disorders (such as psoriasis, vitiligo, Raynaud's phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.|Throughout the entire study period, from Day 0 to Month 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803186|NCT00502593|Secondary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response|A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24.|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803187|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
2803188|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.|||Participants|||Count of Participants
2803189|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.|At Days 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Participants|||Count of Participants
2803190|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.|||Participants|||Count of Participants
2803191|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2803192|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2803328|NCT00501228|Primary|Number of Donor Derived Cells After G-CSF Therapy|In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.|Baseline + 8 Weeks post transplant|No analysis was done. Only one eligible patient was able to complete treatment.||||||
2803193|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2803194|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803195|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803196|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803197|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Participants|||Count of Participants
2803198|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803199|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803200|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803201|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803421|NCT00500682|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)|||participants|||Number
2803202|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803203|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.|At Days 0, 21 and 42 and at Month 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803204|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803205|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803206|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803207|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803208|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803209|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803210|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803327|NCT00501293|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 months|Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.|||Units on a scale||Standard Deviation|Mean
2803211|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803212|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803213|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803214|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803215|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C|Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803216|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803217|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803233|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803218|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803219|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803220|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803221|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803222|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803223|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803224|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803244|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Fold||95% Confidence Interval|Geometric Mean
2803225|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803226|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803227|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803228|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803229|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A|Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803230|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination."|During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803231|NCT00502593|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study (Day 0 to Month 24)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803232|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803234|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature > 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.|||Participants|||Count of Participants
2803235|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on theTotal Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803236|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.|During the 7 day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2803237|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803238|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803239|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803240|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803241|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803242|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803243|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Fold||95% Confidence Interval|Geometric Mean
2803245|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Fold||95% Confidence Interval|Geometric Mean
2803246|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold||95% Confidence Interval|Geometric Mean
2803247|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Fold||95% Confidence Interval|Geometric Mean
2803248|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803249|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803250|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Participants|||Count of Participants
2803251|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803252|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803253|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
2803254|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
2803255|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.|||Titer||95% Confidence Interval|Geometric Mean
2803256|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Titer||95% Confidence Interval|Geometric Mean
2803257|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Titer||95% Confidence Interval|Geometric Mean
2803258|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2803259|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)|Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.|||scores on a scale||Standard Error|Mean
2803260|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)|Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.|||scores on a scale||Standard Error|Mean
2803261|NCT00502320|Primary|Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.|||scores on a scale||Standard Error|Mean
2803262|NCT00502242|Secondary|Percentage of Participants With Hyperkalemia|Hyperkalemia defined as serum potassium >5.6 millimoles per liter (mmol/L)|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2803263|NCT00502242|Secondary|Percentage of Participants With Malignancy|Includes treatment-emergent adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferredterm in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population|||percentage of participants|||Number
2803264|NCT00502242|Secondary|Percentage of Participants With Angioedema|Includes treatment-emergent adverse events based on categorization by the investigator as angioedema, regardless of the event preferred term in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population|||percentage of participants|||Number
2803265|NCT00502242|Secondary|Percentage of Participants With an Infection|Includes treatment-emergent adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA.)|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population|||percentage of participants|||Number
2803266|NCT00502242|Secondary|Percentage of Participants Using Statins||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
2803267|NCT00502242|Secondary|Percentage of Participants With Graft Loss at 24 and 52 Weeks Following Conversion to SRL|Graft loss was defined as physical loss (nephrectomy orretransplantation), functional loss (requiring dialysis for ≥56days with no return of graft function), or death.|24 weeks and 52 weeks after conversion|mITT population|||percentage of participants|||Number
2803279|NCT00502242|Secondary|U Alb/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U alb/c was measured in mg/mg. Baseline U alb/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U alb/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.|||mg/mg||Standard Deviation|Mean
2804120|NCT00494494|Primary|Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)||baseline and 8 weeks||||microns||95% Confidence Interval|Mean
2803268|NCT00502242|Secondary|Number of Participants With BCAR by Severity of First BCAR|Severity was summarized by type (antibody versus T-cell) and by phase: post-SRL (where both on-therapy and off-therapy events are included) and post-SRL (on-therapy). BCAR was categorized using Banff criteria as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate [mod]), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (mod), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category. For participants with T-cell BCAR (post-SRL and post-SRL On -Therapy) the p-value could not be calculated and all events were mild in severity.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; only participants with BCAR were included in the anlaysis.|||participants|||Number
2803269|NCT00502242|Secondary|Percentage of Participants With First BCAR at 24 and 52 Weeks Following Conversion to SRL|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. Participants without BCAR were censored at the time of withdrawal from the study. Defined as the first BCAR occurring on therapy following conversion to SRL based on the mITT population. Time to first BCAR was defined as the date of first BCAR to date of the first dose of SRL (in weeks). Percentages were estimated using the Kaplan-Meier method for time to event data.|24 weeks and 52 weeks after conversion|mITT population; includes BCAR occurring in the On-Therapy and Off-Therapy Periods|||percentage of participants||95% Confidence Interval|Number
2803270|NCT00502242|Secondary|Biopsy-Confirmed Acute Rejection (BCAR) - Number of Participants With an Event|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. The time to the first BCAR was defined as the date of first BCAR to the date of the first dose of SRL (in weeks). Participants without BCAR were censored at the time of withdrawal from the study.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; includes BCAR occurring in On-Therapy and Off-Therapy Periods.|||participants|||Number
2803271|NCT00502242|Secondary|Change From Baseline in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L]) at 4, 12, 24, and 52 Weeks Following Conversion to SRL|Parameters assessed included (all fasting) total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-densitylipoprotein cholesterol (HDL-C).|4, 12, 24, and 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mmol/L||Standard Error|Mean
2803272|NCT00502242|Secondary|Percentage of Participants Using Red Blood Cell Production Stimulants (Erythropoiesis Stimulating Agents [ESAs])||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
2803273|NCT00502242|Secondary|Percentage of Participants With Hemoglobin Levels ≤100 Grams Per Liter (g/L)||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population|||percentage of participants|||Number
2803274|NCT00502242|Secondary|SRL Time-Normalized Trough Concentration (Cmin,TN) by Time Interval|Cmin,TN was determined for SRL using the area method for the intervals: 0-2 weeks, >2-4 weeks, >4-12 weeks, >12-24 weeks, >24-36 weeks and >36-52 weeks using the equation:Cmin,TN = AUCi-j/timej-timeiwhere AUC is the area under the concentration-time curve, i is the beginning of the interval and j is the end of the interval. Cmin,TN was calculated for participants who did not dropout of studies, but were missing concentrations at the interval endpoints by carrying the last observed concentration forward to the interval endpoint.|From Day 1 of SRL conversion to 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter for the given time interval; only participants dosed throughout the interval were included.|||ng/mL||Standard Deviation|Mean
2803275|NCT00502242|Secondary|Percentage of Participants With Potentially Clinically Important Blood Pressure (BP) Values by Diastolic and Systolic BP Category|BP values of potential clinical importance were recorded and categorized as follows: diastolic BP (DBP) ≤50 millimeters of mercury (mmHg) or ≥110 mmHg and systolic BP (SBP) ≤90 mmHg and ≥180 mmHg. Data were summarized for the on-therapy period and the off-therapy period and for the pre-SRL period.|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population|||percentage of participants|||Number
2803276|NCT00502242|Secondary|Fraction of Albumin (Milligrams Per Deciliter [mg/dL]) to Protein (mg/dL) in Urine at 24 and 52 Weeks After Conversion to SRL|Baseline fraction was the last value of the pre-SRL conversion period. Only the last value of U p/c or U alb/c was used for analysis if multiple measurements occurred in the same data anlysis interval. Fraction of albumin and protein was calculated only when urine protein was 6.2 mg/dL or higher. For urine albumin, if the value was reported as '<xx.x', the numerical portion of the value was used in the calculation of fraction of albumin and protein.|24 weeks and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.|||(mg/dL)/(mg/dL)||Standard Deviation|Mean
2803277|NCT00502242|Secondary|Abbreviated Modified Diet in Renal Disease (MDRD) Glomerular Filtration Rate (GFR) at Weeks 12, 24, and 52 Following Conversion to SRL|Calculated in millimeters per minute per 1.73 square meters (mL/min/1.73m^2). Age and corresponding creatinine at each visit (Weeks 12, 24, and 52) were used to calculate GFR.|12, 24, and 52 weeks following conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.|||mL/min/1.73 m^2||Standard Deviation|Mean
2803278|NCT00502242|Secondary|Percentage of Participants Who Discontinued SRL Therapy at 24 and 52 Weeks Following Conversion to SRL|Defined as the percentage of participants who stop SRL (as test article) between the first day of SRL and either Week 24 or Week 52 following conversion to SRL. If a participant had a >14 day gap in SRL use, the stop date of SRL was the date of the last SRL use before it was re-initiated. Participants who early terminate SRL at Week 24 were defined as having SRL stop day less than or equal to (≤) Day 190 (selected as the midpoint between Weeks 24 and 30). Participants who early terminate SRL at Week 52 were defined as having SRL stop day ≤Day 337 (selected as the midpoint between Weeks 44 and 52).|24 weeks and 52 weeks after conversion|mITT population|||percentage of participants|||Number
2803280|NCT00502242|Secondary|U p/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U p/c was measured in milligrams per milligram (mg/mg). The baseline U p/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n (number) = number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U p/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.|||mg/mg||Standard Deviation|Mean
2803281|NCT00502242|Secondary|Percentage of Participants With Both U Alb/c <0.5 and U p/c <0.5 at 24 and 52 Weeks Following Conversion to SRL|The U alb/c and U p/c must have been collected on the same day to be counted as the numerator.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.|||percentage of participants|||Number
2803282|NCT00502242|Secondary|Percentage of Participants With Urinary Albumin to Creatinine Ratio (U Alb/c) <0.5 at 24 and 52 Weeks Following Conversion to SRL|Spot urine sample of albumin and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.|||percentage of participants|||Number
2803283|NCT00502242|Secondary|Percentage of Participants With U p/c <0.5 at 24 and 52 Weeks Following Conversion to Sirolimus|Spot urine sample of protein and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.|||percentage of participants|||Number
2803284|NCT00502242|Secondary|Percentage of Participants Who Had a Dose Escalation in Randomized Test Article (Ramipril or Placebo) by 52 Weeks Following Conversion to SRL|Defined as the time from the first dose of SRL administration to the first dose escalation of randomized test article (ramipril or placebo; in weeks), or censored on the day that a participant stopped the combination of SRL and randomized test article (ramipril or placebo) if the participants did not experience any ramipril/placebo dose escalation following conversion to SRL. Dose-escalation was defined as an increase in total daily dose of ramipril/placebo compared to Day 1 post conversion. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population|||percentage of participants||95% Confidence Interval|Number
2803285|NCT00502242|Primary|Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL|The event for each participant was defined as the initiation of losartan while on SRL and ramipril/placebo combination therapy. Participants who started losartan prior to SRL administration were not counted as events. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|Modified Intent to Treat (mITT) population: all participants in the safety population who took at least one dose of SRL.|||percentage of participants||95% Confidence Interval|Number
2803286|NCT00502216|Secondary|Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline|Tolerability was measured by tracking adverse events. These data are reported in detail in the adverse events section. Presented are an unduplicated count of participants that experienced at least 1 adverse event.|11 weeks||||Participants|||Count of Participants
2803287|NCT00502216|Secondary|Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment||4 weeks|Analyzed are those that remained abstinent for last 4 weeks of treatment|||pounds||Standard Deviation|Mean
2803288|NCT00502216|Primary|Weight Gain in Treatment Completers||baseline and 12 weeks|Subpopulation of participants who reported quitting smoking|||Pounds||Standard Deviation|Mean
2803289|NCT00502203|Primary|Number of Participants With Overall Response|Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required.|24 Months|Thirteen participants had measurable disease therefore evaluable for a complete or partial response.|||participants|||Number
2803290|NCT00501995|Secondary|Change in the HAQ-DI, PGA, FVC and DLCO|The Health Assessment Questionnaire-Disability Index (HAQ-DI) a 48 item questionnaire assessing ability to perform activities of daily living, use of assistive devises and a 6 item analog scale of pain severity from 0 cm (no pain) to 14.3 cm (very severe pain). The lower the HAQ-DI score the less the disability. The physician global assessment (PGA) which is a visual analogue scale from 0 to 100 on which the physician rates the patient's disease severity based on their observations. A score of 0 is no disease activity and 100 is the worst possible disease activity. The Forced Vital Capacity (FVC) measure of lung capacity and Diffusing Capacity (DLCO) measures of oxygen exchange in the alveoli ( pulmonary function testing). The predicted lung volumes were referenced from NHANES/Hanikson et al and for DLCO predicts were from Knudson. Pre and post study percent predicted values were compared.|0-24 months|The study group consisted of 4 men and 2 women aged 19-60 years of old.|||percentage change||Full Range|Mean
2803291|NCT00501995|Primary|Improvement in the Modified Rodnan Skin Score.|The modified Rodnan skin score is the accepted clinical measure of scleroderma skin activity. The investigator will assess the thickening of the skin using the modified Rodnan skin score through simple palpation on 17 different body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness is assessed on a scale of 0-3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0-51; 0 (normal) to 51 (severe thickening in all 17 areas) A 25% improvement in the modified Rodnan Skin score will be considered significant at any time point in the study. Modified Rodnan Skin Score was evaluated at months 0,1,3,6,12 and 24 months.|0 to 24 months|Patient 4 died during the early phase of the study and longitudinal assessment of his skin score was not determined.|||percent improvement from baseline||Full Range|Mean
2803325|NCT00501293|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT|||Participants|||Number
2803292|NCT00501969|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.|||Score on a scale||Standard Deviation|Mean
2803293|NCT00501969|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
2803294|NCT00501969|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).|||Subjects|||Number
2803295|NCT00501943|Secondary|Changes in Normalized Grey Matter Volume|The baseline data of grey matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12 and Month-24||||percent change per year||95% Confidence Interval|Mean
2803296|NCT00501943|Secondary|Changes in Symbol Digit Modality Test (SDMT)|Baseline SDMT data were compared to SDMT data collected during the timepoints. A simple substitution task, the SDMT gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
2803297|NCT00501943|Secondary|Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)|Baseline RNFL data is compared to the RNFL data collected during the timepoint, and the changes in RNFL is measured using optical coherence tomography (OCT).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
2803298|NCT00501943|Secondary|Changes in MS Functional Composite (MSFC)|Baseline MSFC data is compared to MSFC data collected during the timepoints. The MSFC is a three-part, standardized, quantitative, assessment instrument that measures the clinical dimensions of leg function, arm/hand function and cognitive function and the components include Timed 25-Foot walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test.|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
2803299|NCT00501943|Secondary|Changes in Normalized White Matter Volumes (nWMV)|The baseline data of white matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24||||percent change per year||95% Confidence Interval|Mean
2803300|NCT00501943|Primary|MRI Parameter- Percent Brain Volume Change for 2 Years|Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|Multivariate regression model was used as the statistical method of analysis for the study. So data from patients who have not completed the study are also used for statistical analysis.|||percent change per year||95% Confidence Interval|Mean
2803301|NCT00501891|Secondary|Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity|27 months|Intent to treat|||participants|||Number
2803302|NCT00501891|Secondary|Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage|Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage|27 months|Intent to treat|||participants|||Number
2803303|NCT00501891|Secondary|Response Rate|The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|27 months|Intent to treat|||Number of participants|||Number
2803304|NCT00501891|Primary|6-Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. [Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).]|6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2803305|NCT00501852|Secondary|Least Squares Means of FEV1 (L) at Day 1, by Timepoint|FEV1 was measured at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23 hours and 15 minutes, and 23 hours and 45 minutes post dose.|Day 1||||Liters||Standard Error|Least Squares Mean
2803306|NCT00501852|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing.|Day 7|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.|||Liters||Standard Error|Least Squares Mean
2803307|NCT00501644|Primary|Number of Patients With Response|Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.|Follow up CT scans after every 3 courses of treatment and following completion of all treatments.|Analysis per protocol. Of 59 participants enrolled, five (5) were not evaluable.|||Participants|||Number
2803308|NCT00501631|Secondary|Longer-term Safety of VIVITROL|Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.|up to 1 year|||||||
2803309|NCT00501631|Primary|Cumulative Percentage of Participants by Heavy Drinking Rate|"Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A heavy drinking day was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary)."|up to 12 weeks|The primary endpoint is based on percentage rate of heavy drinking days during the double-blind treatment period as per protocol.|||percentage of participants|||Number
2803310|NCT00501592|Secondary|Hepatocellular Function|Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function|baseline and 6 weeks||||U/L||Standard Deviation|Mean
2803311|NCT00501592|Primary|Insulin Resistance and Glucose Homeostasis|The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).|baseline and 6 weeks||||mg/kg/min||Standard Deviation|Mean
2803312|NCT00501540|Secondary|Overall Survival (OS)|Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.|Up to 4 years|The median OS time had not been reached.|||participants||Full Range|Median
2803313|NCT00501540|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.|Up to 4 years||||months||95% Confidence Interval|Median
2803314|NCT00501540|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.|Up to 4 years||||participants|||Number
2803315|NCT00501345|Primary|Participants With 7 Days Observation Without Severe Bleeding|Blood samples collected at baseline before or after aspirin is given and at 24 hours, 72 hours and 7 days after treatment has been initiated for those that remain in the study after the first 24 hours.|7 Days|The baseline Thromboelastogram showed normal platelet function in all patients and no evidence of heparin induced thrombocytopenia (HIT). No further analysis was done as study was terminated due to lack of accrual.||||||
2803316|NCT00501293|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|6 months|Safety Population|||Participants|||Number
2803317|NCT00501293|Primary|Weight||Baseline and 6 months|Safety population|||lb||Standard Deviation|Mean
2803318|NCT00501293|Primary|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|6 months|Safety Population|||Participants|||Number
2803319|NCT00501293|Primary|Electrocardiogram Results (QTcF Interval)|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 6 months|Safety Population|||msec||Standard Deviation|Mean
2803320|NCT00501293|Primary|Pulse Rate||Baseline and 6 months|Safety population|||beats per minute||Standard Deviation|Mean
2803321|NCT00501293|Primary|Diastolic Blood Pressure||Baseline and 6 months|Safety population|||mmHg||Standard Deviation|Mean
2803322|NCT00501293|Primary|Systolic Blood Pressure||Baseline and 6 months|Safety population defined as all subjects that received at least one dose of MTS.|||mmHg||Standard Deviation|Mean
2803323|NCT00501293|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 6 months|ITT. Not all subjects in the ITT population completed a YQOL-R.|||Units on a scale||Standard Deviation|Mean
2803324|NCT00501293|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT|||Participants|||Number
2804121|NCT00494494|Primary|Foveal Thickness|difference in mean pre-post changes by the two treatment groups|baseline and 8 weeks||||microns||95% Confidence Interval|Mean
2803329|NCT00501085|Secondary|Subject Reported Sleepiness (Epworth Sleepiness Scale)|The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||units on a scale||Standard Deviation|Mean
2803330|NCT00501085|Secondary|Subject Reported Quality of Life|Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||units on a scale||Standard Deviation|Mean
2803331|NCT00501085|Secondary|Subject Reported Satiety|Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||units on a scale||Standard Deviation|Mean
2803332|NCT00501085|Secondary|Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation|Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||kg/m2||Standard Deviation|Mean
2803333|NCT00501085|Primary|Change in Percent Excess Weight|Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.|||percentage of excess weight lost||Standard Deviation|Mean
2803334|NCT00501059|Other Pre-specified|Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population|*all other CV death without fatal MI and fatal stroke.|Until follow-up (approximate 6 years)|Per-protocol (PP) group (N=7702) consists of all patients who had no protocol violation.|||Percentage of participants|||Number
2803335|NCT00501059|Other Pre-specified|Incidence of Composite Outcomes and Non-fatal MI||Until follow-up (approximate 6 years)|ITT|||Percentage of participants|||Number
2803336|NCT00501059|Other Pre-specified|Number of Subjects With Adjudicated GI Bleeding by Severity||Until follow-up (approximate 6 years)|ITT|||Participants|||Count of Participants
2803337|NCT00501059|Secondary|Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately|The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. *all other CV death without fatal MI and fatal stroke|Until follow-up (approximately 6 years)|ITT|||Percentage of participants|||Number
2803338|NCT00501059|Secondary|Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer||Until follow-up (approximately 6 years)|ITT|||Percentage of participants|||Number
2803339|NCT00501059|Secondary|Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer|The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximately 6 years)|ITT|||Days|Days||Count of Units
2803340|NCT00501059|Secondary|Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA|The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximately 6 years)|ITT|||Days|Days||Count of Units
2803341|NCT00501059|Secondary|Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)|The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximate 6 years)|ITT|||Days|Days||Count of Units
2803342|NCT00501059|Primary|Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)|The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.|Until follow-up (approximate 6 years)|Intention-to-treat. The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug.|||Days|Days||Count of Units
2803343|NCT00501046|Secondary|Vitamins and Folate Levels||approximately 42 months|||||||
2803344|NCT00501046|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function and (QOL: Exploratory)||approximately 42 months|||||||
2803345|NCT00501046|Primary|Safety and Tolerability||approximately 42 months|||||||
2803346|NCT00501046|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)|||participants|||Number
2803422|NCT00500656|Secondary|Time to Almost Complete Symptom Relief|Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms.|48 hours||||Hours||Inter-Quartile Range|Median
2803347|NCT00501007|Secondary|Persistence as a Prospective Predictor of Smoking Cessation|Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.|6 months||||Odds ratio||95% Confidence Interval|Number
2803348|NCT00501007|Primary|Mirror-tracing Persistence (in Seconds)|Number of seconds participants continued working on a mirror tracing task before giving up.|baseline|All meeting inclusion criteria|||seconds||Standard Deviation|Mean
2803349|NCT00500903|Secondary|Effect of Food on the Pharmacokinetics (PK) of Alisertib|The effects of food on the PK of alisertib were to be evaluated using the preferred alisertib regimen (unit dose and formulation) based on the results from the relative bioavailability study.|Up to 6 months|The effects of food on the PK of alisertib was not conducted. As the development of alisertib was transitioned from the PIC to the ECT formulation and the clinical dose of alisertib ECT had not been determined yet, it was decided that the effect of food would be evaluated in a different study at the appropriate clinical dose, administered as ECT.||||||
2803350|NCT00500903|Secondary|Duration Of Response (DOR)|DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.|Beginning at the end of Cycle 2, every 2 cycles until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU) every 8-12 weeks until PD or as per institutional practice (Up to 33.2 months)|Safety Population included all participants who received any amount of study drug.|||days|||Number
2803351|NCT00500903|Secondary|Best Overall Response Based on Investigator Assessment|Best overall response is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. According to RECIST: CR is defined as disappearance of all target and nontarget lesions and normalization of tumor marker level (if applicable); PR is defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.|Beginning at the end of Cycle 2, every 2 cycles until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU) every 8-12 weeks until PD or as per institutional practice (Up to 33.2 months)|Safety Population included all participants who received any amount of study drug.|||percentage of participants|||Number
2803352|NCT00500903|Secondary|Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1|"One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype patients for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib.~wt=wild type~*28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression."|Cycle 1 Day 1 predose|Safety Population included all participants who received any amount of study drug.|||participants|||Number
2803353|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Twice Daily for 14 Days (BID14D) Dosing|Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 7, 6 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||apoptotic cells/millimeter of BEL||Standard Deviation|Mean
2803354|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Twice Daily for 14 Days (BID14D) Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers—serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 7, 6 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||mitotic cells/millimeter of BEL||Standard Deviation|Mean
2803355|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Twice Daily for 7 Days (BID7D) Dosing|Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Day 7, 6 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||apoptotic cells/millimeter of BEL||Standard Deviation|Mean
2803356|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Twice Daily for 7 Days (BID7D) Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers—serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Day 7, 6 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||mitotic cells/millimeter of BEL||Standard Deviation|Mean
2803357|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 21 Days (QD21D) Dosing|Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Days 7 and 21, 6 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||apoptotic cells/millimeter of BEL||Standard Deviation|Mean
2803358|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 21 Days (QD21D) Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers—serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Days 7 and 21, 6 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||mitotic cells/millimeter of BEL||Standard Deviation|Mean
2803359|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 14 Days (QD14D) Dosing|Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­points.|||apoptotic cells/millimeter of BEL||Standard Deviation|Mean
2803360|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 14 Days (QD14D) Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers—serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­points.|||mitotic cells/millimeter of BEL||Standard Deviation|Mean
2803361|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 7 Days (QD7D) Dosing|Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­points.|||apoptotic cells/millimeter of BEL||Standard Deviation|Mean
2803362|NCT00500903|Secondary|Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 7 Days (QD7D) Dosing|Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers—serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.|Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­points.|||mitotic cells/millimeter of BEL||Standard Deviation|Mean
2803363|NCT00500903|Secondary|Cmax: Maximum Observed Concentration as Assessment of Relative Bioavailability for Alisertib as Enteric-coated Tablet (ECT) Versus PIC at Day 7||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||nM||Standard Deviation|Mean
2803364|NCT00500903|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t as Assessment of Relative Bioavailability for Alisertib as Enteric-coated Tablet (ECT) Versus PIC at Day 7||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||nM*h||Standard Deviation|Mean
2803365|NCT00500903|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2803366|NCT00500903|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing||Cycle 1 Days 1 and 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||h||Full Range|Median
2803367|NCT00500903|Secondary|Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing||Cycle 1 Days 1 and 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM||Geometric Coefficient of Variation|Geometric Mean
2803368|NCT00500903|Secondary|CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng||Standard Deviation|Mean
2803369|NCT00500903|Secondary|Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng||Standard Deviation|Mean
2803370|NCT00500903|Secondary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2803371|NCT00500903|Secondary|Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||ratio||Standard Deviation|Mean
2803372|NCT00500903|Secondary|Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||ratio||Standard Deviation|Mean
2803373|NCT00500903|Secondary|Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 8|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||h||Standard Deviation|Mean
2803374|NCT00500903|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2803375|NCT00500903|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||h||Full Range|Median
2803376|NCT00500903|Secondary|Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM||Geometric Coefficient of Variation|Geometric Mean
2803377|NCT00500903|Secondary|CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Day 1 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||L/h||Standard Deviation|Mean
2803378|NCT00500903|Secondary|Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Day 1 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng||Standard Deviation|Mean
2803379|NCT00500903|Secondary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Days 14 and 21 predose and at multiple timepoints up to 10 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2803380|NCT00500903|Secondary|Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Days 14 and 21 predose and at multiple timepoints up to 10 hours postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ratio||Standard Deviation|Mean
2803381|NCT00500903|Secondary|Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Days 14 and 21 predose and at multiple timepoints (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||ratio||Standard Deviation|Mean
2803382|NCT00500903|Secondary|Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Day 21 predose and at multiple time points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time­point.|||h||Standard Deviation|Mean
2803383|NCT00500903|Secondary|AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2803384|NCT00500903|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||h||Full Range|Median
2803385|NCT00500903|Secondary|Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing||Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM||Geometric Coefficient of Variation|Geometric Mean
2803386|NCT00500903|Secondary|CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||L/h||Standard Deviation|Mean
2803387|NCT00500903|Secondary|Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng||Standard Deviation|Mean
2803388|NCT00500903|Secondary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||L/h||Standard Deviation|Mean
2803389|NCT00500903|Secondary|Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ratio||Standard Deviation|Mean
2803390|NCT00500903|Secondary|Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ratio||Standard Deviation|Mean
2803391|NCT00500903|Secondary|Terminal Half-Life for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Day 14 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||h||Standard Deviation|Mean
2803392|NCT00500903|Secondary|AUCt: Area Under the Concentration--Time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2803393|NCT00500903|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||h||Full Range|Median
2803394|NCT00500903|Secondary|Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2811737|NCT00439569|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area Under the Plasma Concentration versus Time curve (AUC)|12 weeks||||µmol/L * hours||Standard Deviation|Mean
2803395|NCT00500903|Secondary|CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||L/h||Standard Deviation|Mean
2803396|NCT00500903|Secondary|Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng||Standard Deviation|Mean
2803397|NCT00500903|Secondary|CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.|||liters (L)/h||Geometric Coefficient of Variation|Geometric Mean
2803398|NCT00500903|Secondary|Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.|||ratio||Standard Deviation|Mean
2803399|NCT00500903|Secondary|Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.|||ratio||Standard Deviation|Mean
2803400|NCT00500903|Secondary|Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.|||h||Standard Deviation|Mean
2803401|NCT00500903|Secondary|AUCt: Area Under the Concentration-Time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2803402|NCT00500903|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||hours (h)||Full Range|Median
2803403|NCT00500903|Secondary|Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing||Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose|Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.|||nM||Geometric Coefficient of Variation|Geometric Mean
2803404|NCT00500903|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From first dose of study drug to 30 days after the last dose (up to 1011 days)|Safety Population included all participants who received any amount of study drug.|||participants|||Number
2803405|NCT00500903|Primary|Maximum Tolerated Dose (MTD) of Alisertib|MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 patients.|From first dose of study drug to 30 days after the last dose (up to 1011 days)|DLT-Evaluable Population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.|||mg BID for 7 Days|||Number
2803417|NCT00500760|Primary|Local Regional Control Rate at 2 Years|In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|2 years|Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.)|||proportion of paticipants||95% Confidence Interval|Number
2803418|NCT00500682|Secondary|Vitamins and Folate Levels||approximately 42 months|||||||
2803419|NCT00500682|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function||approximately 42 months|||||||
2803420|NCT00500682|Primary|Safety and Tolerability||approximately 42 months|||||||
2803406|NCT00500903|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|"DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:~Grade 4 neutropenia lasting ≥7 consecutive days~Grade 4 neutropenia with fever and/or infection~Platelet count <25,000/mm^3~Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis~Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide~Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (<1 week) Grade 3 fatigue~Treatment delay of >1 week due to failure of adequate hematologic or nonhematologic recovery from previous cycle of treatment~Other alisertib-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required a dose reduction or discontinuation of therapy with alisertib."|Cycle 1 Day 1 up to Day 35 (alisertib daily for 7 to 21 days followed by a 14-day recovery period)|DLT-Evaluable Population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.|||participants|||Number
2803407|NCT00500890|Secondary|Secondary Objective Response|To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based therapy treatment with the response rates after two blocks of carboplatin based treatment.|No data were collected due to early termination|No data were collected due to early termination||||||
2803408|NCT00500890|Secondary|Secondary Objective Resectability|To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based therapy treatment with the resectability after two blocks of carboplatin based treatment. Success of surgery after first 2 cycles of chemotherapy will be compared between two treatment arms. Percentage of patients with secondary complete remission from those with incomplete primary resection, will be used to analyze question. Tumor with CR and tumors which could be completely resected after two cycles of chemotherapy will be counted together. Frequency will be compared a month the 2 treatment arms using Chi-square test.|No data were collected due to early termination|No data were collected due to early termination.||||||
2803409|NCT00500890|Primary|Secondary Objective SV40|To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors. Prognosis of tumors with or without SV40 will be compared using overall survival time as endpoint. Kaplan Meier survival estimates and log rank tests as statistical methods similar to the analysis of primary objective.|No data were collected due to early termination|No data were collected due to early termination||||||
2803410|NCT00500890|Primary|Main Phase (Started in 2006) Primary Specific Objective|To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.|After randomization until the end of the observation or the death of the patient|No data were collected due to early termination.||||||
2803411|NCT00500760|Secondary|Percentage of Participants With a Complete Response at 6 Months|Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.|6 months|Evaluable for Central Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
2803412|NCT00500760|Secondary|Percentage of Participants With an Objective Response at 6 Months|"Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months.~Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions."|6 months|Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review.|||percentage of participants||95% Confidence Interval|Number
2803413|NCT00500760|Secondary|Overall Survival|Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.|From first dose date up to 37 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
2803414|NCT00500760|Secondary|Progression-Free Survival|"Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death.~Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions.~Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date."|From first dose date to 37 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
2803415|NCT00500760|Secondary|Duration of Local-regional Control|Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.|From first dose up to 37 months|Efficacy Analysis Set|||months||95% Confidence Interval|Median
2803416|NCT00500760|Secondary|Local Regional Control Rate at 6 Months and 12 Months|Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|6 months and 12 months|Efficacy Analysis Set|||proportion of paticipants||95% Confidence Interval|Number
2803423|NCT00500656|Primary|Time to Onset of Symptom Relief.|"The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group.~TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.~The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|2 days||||Hours||Inter-Quartile Range|Median
2803424|NCT00500578|Primary|Occurrences of Pneumonia|Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.|6 Years|The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.|||Participants|||Number
2803425|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).|Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.|||participants|||Number
2803426|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.|24 weeks treatment period + 4 weeks for following up participants|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.|||participants|||Number
2803427|NCT00500539|Primary|The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period|An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.|16 weeks after last dose|The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken.|||participants|||Number
2803428|NCT00500448|Primary|Change From Baseline in Quadriceps Strength at 12 Weeks||Baseline and 12 weeks following the intervention||||Nm/kg||95% Confidence Interval|Mean
2803429|NCT00500448|Secondary|Change From Baseline in WOMAC Pain Score at 12 Weeks|WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)|Baseline and 12 weeks following intervention||||units on a scale||95% Confidence Interval|Mean
2803430|NCT00500448|Secondary|Change From Baseline in Timed Walking Speed at 12 Weeks||Baseline and 12 weeks post-intervention||||m/s||95% Confidence Interval|Mean
2803431|NCT00500448|Secondary|Change From Baseline in WOMAC Disability Score at 12 Weeks|Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)|baseline and 12 weeks post-intervention||||units on a scale||95% Confidence Interval|Mean
2803432|NCT00500448|Primary|Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks|Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus|Baseline and 12 weeks post-intervention||||unitless||95% Confidence Interval|Mean
2803433|NCT00500370|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|24 weeks|Intent to Treat population|||percent||Standard Error|Least Squares Mean
2803434|NCT00500370|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)|24 weeks|Intent to Treat population|||pmol/L||Standard Error|Least Squares Mean
2803435|NCT00500370|Secondary|Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)|Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24|24 weeks|Intent to Treat population|||Participants|||Number
2803436|NCT00500370|Secondary|Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis|Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24|24 weeks|Intent to Treat population|||Participants|||Number
2803437|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)|Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.|24 weeks|Intent to Treat population; Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
2803438|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)|Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.|24 weeks|Intent to Treat population; Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
2803439|NCT00500370|Secondary|Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)|Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||(mmol*hr)/L||Standard Error|Least Squares Mean
2803440|NCT00500370|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)|24 weeks|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
2803441|NCT00500370|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2803442|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)|Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
2803443|NCT00500370|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2803444|NCT00500370|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2803445|NCT00500370|Secondary|Percentage of Patients Experiencing >=5% Weight Loss|Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%)|24 weeks|Intent to Treat population; Last Observation Carried Forward|||percentage of patients|||Number
2803446|NCT00500370|Secondary|Change in Waist-to-hip Ratio|Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.|24 weeks|Intent to Treat population|||Ratio||Standard Error|Least Squares Mean
2803447|NCT00500370|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)|24 weeks|Intent to Treat population|||kg/m^2||Standard Error|Least Squares Mean
2803448|NCT00500370|Primary|Change in Body Weight|Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)|24 weeks|Intent to Treat population|||kg||Standard Error|Least Squares Mean
2803449|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.|||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
2803450|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.|||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
2803451|NCT00500357|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2803452|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2803478|NCT00500292|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)||||Participants|||Number
2813423|NCT00428441|Primary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels|Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis|1 year||||participants|||Number
2803453|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.|||percentage of participants|||Number
2803454|NCT00500357|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2803455|NCT00500331|Secondary|Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern|Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Up to 14 weeks|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2803456|NCT00500331|Secondary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was >500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 msec, the participant was withdrawn from the study.|Up to Early withdrawal (Between Week 12 and Week 14)|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2803457|NCT00500331|Secondary|Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern|Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Up to 14 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2803458|NCT00500331|Secondary|Number of Participants With On-therapy Hypoglycemia|Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events.|Up to 14 weeks|Safety Population.|||Participants|||Count of Participants
2803459|NCT00500331|Secondary|Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 12 weeks|Safety population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2803467|NCT00500331|Secondary|Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L|Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 mmo/L (126 milligram/deciliter [mg/dL]), FPG <7.8 mmol/L (140 mg/dL); FPG <5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c >= 0.7%; a decrease from Baseline of FPG ≥1.7 mmol/L (30 mg/dL) are presented.|Week 12|ITT Population with Last Observation Carried Forward (LOCF). Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Participants|||Count of Participants
2803460|NCT00500331|Secondary|Change From Baseline in C-peptide AUC During a 2-hr OGTT|"Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values."|Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)|OGTT with LOCF Population. Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Nanomol*hour per Liter (nmol*hr/L)||Standard Deviation|Mean
2803461|NCT00500331|Secondary|Change From Baseline in Insulin AUC During a 2-hour OGTT|"Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values."|Baseline (Week 0) and Week 12 (0 to 2-hour OGTT)|OGTT with LOCF Population. Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Picomol*hour per Liter (pmol*hr/L)||Standard Deviation|Mean
2803462|NCT00500331|Secondary|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT)|"Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time 0 started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values."|Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)|The OGTT Population with LOCF which comprised of participants in the ITT population having evaluable Baseline and corresponding on-therapy OGTT measurements (for at least one of the measured parameters of FPG, C-Peptide or Insulin). Only those participants with a value at Baseline and at Week 12 (after LOCF) were used for this analysis.|||Millimol*hour per Liter (mmol*hr/L)||Standard Deviation|Mean
2803463|NCT00500331|Secondary|Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine|A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 12 (24-hour urine collection)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of filtered glucose molecules||Standard Deviation|Mean
2803464|NCT00500331|Secondary|Change From Baseline to Week 12 in Waist Circumference|Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT population with LOCF for withdrawn participants or missing values.|||Centimeters||Standard Deviation|Mean
2803465|NCT00500331|Secondary|Change From Baseline to Week 12 in Body Weight|Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT population with LOCF for withdrawn participants or missing values.|||Kilograms||Standard Deviation|Mean
2803466|NCT00500331|Secondary|Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C])|Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100*(exponentiated(mean change on log scale)-1)|Baseline (Week 0) and Week 4, Week 8 and Week 12|ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis.|||Percent change||Full Range|Median
2803477|NCT00500318|Primary|Change From Baseline in Exercise Endurance Time (ET)|Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.|From baseline Week 0 (Visit 4) to Week 6 (Visit 6)|Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.|||Seconds||Standard Error|Least Squares Mean
2803468|NCT00500331|Secondary|Change From Baseline to Week 12 in Fasting Insulin|Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population with LOCF. Only those participants with a value at Baseline and up to Week 12 (after LOCF) were used for this analysis.|||Picomol per Liter (pmol/L)||Standard Deviation|Mean
2803469|NCT00500331|Secondary|Change From Baseline to Week 12 in Fructosamine|Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) to Week 12|ITT Population with LOCF. Only those participants with a value at Baseline up to Week 12 (after LOCF) were used for this analysis.|||Micromol per Liter (mcmol/L)||Standard Deviation|Mean
2803470|NCT00500331|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12|Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 4, Week 8 and Week 12|ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis. One extreme outlier participant had withdrawn from Placebo arm due to lack of efficacy.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2803471|NCT00500331|Secondary|Change From Baseline in HbA1c (%) at Weeks 4 and 8|Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Week 0) and Week 4 and Week 8|ITT Population with LOCF. Only those participants with a value at Baseline and at specified visits (after LOCF) were used for this analysis. One extreme outlier participant had withdrawn from Placebo arm due to lack of efficacy.|||Percentage of hemoglobin||Standard Deviation|Mean
2803472|NCT00500331|Primary|Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12|Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward [LOCF]) were used for this analysis. Adjusted mean is presented as least square mean.|Baseline (Week 0) and Week 12|Intent to Treat (ITT) Population with LOCF comprised of all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. One extreme outlier participant had withdrawn from Placebo arm (lack of efficacy).|||Percentage of hemoglobin||Standard Error|Least Squares Mean
2803473|NCT00500318|Secondary|Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio|Ratio of trough Inspiratory Capacity verses Total Lung Capacity.|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2803474|NCT00500318|Secondary|Functional Residual Capacity (FRC)|Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||L||Standard Error|Least Squares Mean
2803475|NCT00500318|Secondary|Trough Inspiratory Capacity (IC)|Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||L||Standard Error|Least Squares Mean
2803476|NCT00500318|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).|Change from baseline (Visit 4) at Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).|||L||Standard Error|Least Squares Mean
2803479|NCT00500240|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count >1.0 × 10^9/L, platelet count >100 × 10^9/L, no abnormal peripheral blasts, and <5% blasts in normocellular or hypercellular bone marrow.|Date of complete remission to disease progression, assessed for approximately 6 years|There were 51 evaluable participants.|||Months||Full Range|Median
2803480|NCT00500240|Primary|Overall Survival|Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up.|Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years||||Months|Participants|Full Range|Median
2803481|NCT00500240|Primary|1-Year Overall Survival Rate|The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.|1 year|There were 51 evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2803482|NCT00500149|Secondary|Duration of Effect of Vyvanse|Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on intention-to-treat (ITT) population.|||scores on a scale||Standard Error|Least Squares Mean
2803483|NCT00500149|Primary|Onset of Effect of Vyvanse|The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on the intention-to-treat (ITT) population.|||scores on a scale||Standard Error|Least Squares Mean
2803484|NCT00500110|Primary|Number of Participants Achieving Pathological Complete Response|Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.|Every 3 months for 1 year, then every 6 months until disease progression or death|Analysis was per protocol.|||participants|||Number
2803485|NCT00500071|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks|Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Baseline and 7 weeks|ITT|||Units on a scale||Standard Deviation|Mean
2803486|NCT00500071|Secondary|Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks|Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.|Baseline and 7 weeks|ITT|||Units on a scale||Standard Deviation|Mean
2803487|NCT00500071|Secondary|Number of Participants With Improvement onParent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 weeks|ITT|||Participants|||Number
2803488|NCT00500071|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 or 2 on the scale.|7 weeks|ITT|||Participants|||Number
2803489|NCT00500071|Primary|Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7 weeks|Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available.|||Units on a scale||Standard Error|Mean
2803490|NCT00500071|Secondary|Weekly Change From Baseline in Total ADHD-RS-IV Score|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks|ITT|||Units on a scale||Standard Error|Mean
2803491|NCT00500045|Secondary|A Decrease in the Thickness of the Retina|0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.|one year|0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.||||||
2803492|NCT00500045|Primary|An Improvement in Vision in the the Treatment Patients, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.|0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.|one year|0 participants analyzed for the overall number of participants analyzed. The PI has retired and left the institution. Efforts were made to contact the PI but were unsuccessful. No study data are available for any results modules.||||||
2803493|NCT00499915|Secondary|Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.||2, 5, and 7-9 months post baseline|||||||
2803494|NCT00499915|Primary|Infants Living in Smoke-free Environments.|"Infants living in homes with a home smoking ban rule"|5 months post baseline||||participants|||Number
2803557|NCT00499473|Primary|Dose Resulting in Steady-state Trough|Average of pre-dose values of sunitinib + SU12662 plasma concentrations equivalent to that observed in patients not receiving EIAC based on pharmacokinetic modeling.|At baseline (day 8) and days 15, 22, and 23|Not determined due to early termination of the study due to lack of efficacy||||||
2803495|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant DLI|Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 year|Only 8 participants having the post-transplant DLI out of the 41 participants treated were analyzed for this outcome.|||Participants|||Number
2803496|NCT00499889|Primary|Number of Participants in Complete Molecular Remission at 1 Year|Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).|Baseline to 1 year|Analysis was per protocol. One patient did not receive treatment and was excluded from analysis.|||participants|||Number
2803497|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy|Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 Year|Analysis was per protocol. Only 19 participants having the post transplant Imatinib Mesylate Therapy out of the 41 participants treated were analyzed for this outcome.|||Participants|||Number
2803498|NCT00499863|Secondary|Change From Baseline in Weight at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population|||lbs||Standard Deviation|Mean
2803499|NCT00499863|Secondary|Change From Baseline in Diastolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)||||mmHg||Standard Deviation|Mean
2803500|NCT00499863|Secondary|Change From Baseline in Systolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population|||mmHg||Standard Deviation|Mean
2803501|NCT00499863|Secondary|Change From Baseline in Pulse Rate at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population|||bpm||Standard Deviation|Mean
2803502|NCT00499863|Secondary|Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and endpoint (up to 7 weeks)|Safety population|||msec||Standard Deviation|Mean
2803503|NCT00499863|Secondary|Dermal Response Scale (DRS) Scores|Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|up to 7 weeks|Safety population which included all randomized subjects that received at least one dose of MTS or PTS.|||scores on a scale||Standard Deviation|Mean
2803504|NCT00499863|Other Pre-specified|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 7 weeks|Safety population (Note: not everyone in the safety population completed a sleep questionnaire)|||Participants|||Number
2803505|NCT00499863|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint|The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often).|Baseline and endpoint (up to 7 weeks)|ITT|||scores on a scale||Standard Error|Least Squares Mean
2803506|NCT00499863|Secondary|Improvement in Parent Global Assessment (PGA) Score|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT|||Participants|||Number
2803507|NCT00499863|Secondary|Improvement in Clinical Global Impressions-Improvement (CGI-I) Score|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT|||Participants|||Number
2803508|NCT00499863|Secondary|Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).|Baseline and endpoint (up to 7 weeks)|ITT|||scores on a scale||Standard Error|Least Squares Mean
2803509|NCT00499863|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint|The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|baseline and endpoint (up to 7 weeks)|Intent-to-treat (ITT) which included all randomized subjects who received at least one dose of MTS or PTS, and had one Baseline and at least one post-Baseline assessment.|||scores on a scale||Standard Error|Least Squares Mean
2803510|NCT00500266|Primary|Percentage of Participants Taking Pain or Antipyretic Medication|Use of pain or antipyretic medication was collected by the participants using an electronic diary.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.|||Percentage of Participants||95% Confidence Interval|Number
2803511|NCT00500266|Primary|Percentage of Participants With Pre-specified Systemic Events|Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.|||Percentage of Participants||95% Confidence Interval|Number
2803512|NCT00500266|Primary|Percentage of Participants With Pre-specified Local Reactions|Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting “yes” for at least 1 day or “no” for all days.|||Percentage of Participants||95% Confidence Interval|Number
2803513|NCT00499746|Secondary|Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)|"The Visual Analog Scale (VAS) measures subjective ratings of stimulant effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure."|Measure at 120 min after drug administration||||units on a scale||Standard Error|Mean
2803514|NCT00499746|Secondary|Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)|"The Visual Analog Scale (VAS) measures subjective ratings of opioid agonist effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure on VAS."|Measure at 120 min after drug administration||||units on a scale||Standard Error|Mean
2803515|NCT00499746|Secondary|Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter|Change in pupil diameter (mm) at peak (120 min) compared to baseline measure of pupil diameter|Measure at 120 min after drug administration||||mm||Standard Error|Mean
2803516|NCT00499746|Secondary|Physiologic Effects Assessed by the Pharmacological Class Questionnaire|"During the peak (assessed at 120 min) of each drug administration, participants were asked to complete the pharmacological class questionnaire. The pharmacological class questionnaire had volunteers indicate which drug class was most similar to the drug condition they received. Ten drug classes were listed with descriptive labels and examples of each: placebo, opiates (or opioid agonist), phenothiazines, barbiturates, antidepressants, opiate antagonists, hallucinogens, benzodiazepines, stimulants, and other. Of these choices, participants chose 3: placebo, opioid agonist, and stimulant.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition."|Measure at 120 min after drug administration||||percentage of drug identification|||Number
2803517|NCT00499746|Primary|Discrimination Effects Assessed by Discrete Choice|"During discrete choice, volunteers were given three choices (placebo, hydromorphone, methylphenidate) and were asked to choose which of the training drugs they thought they received. The outcome measure illustrates the percentage of participants who chose either placebo, hydromorphone, or methylphenidate during each drug condition (i.e., Placebo, Hydromorphone 8 mg, Tramadol 50 mg, etc.), ranging from 0-100.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition."|1 day||||percentage of drug identification|||Number
2803518|NCT00499746|Primary|Discrimination Effects Assessed by Point Distribution|In point distribution, volunteers distributed 50 points among three training drug letters depending on how certain they were of the identity of the administrated drug. Maximum total is 50 points.|1day||||Points distributed||Standard Error|Mean
2803519|NCT00499746|Primary|Discrimination Effects Assessed by Operant Responses|Volunteers emitted operant responses on computer keys that corresponded to the training letter, on a fixed interval 1 second schedule for 8.5 minutes. The range is from 0 to 500 operant responses.|1 day||||Responses||Standard Error|Mean
2803520|NCT00499746|Primary|Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test|The acquisition of discrimination was to test whether volunteers could identify each training drug condition by the correct letter code. Results are the percentage of correct responses with a range of 0% to 100%.|1 day||||percent of correct response||Full Range|Mean
2803521|NCT00499694|Secondary|Overall Survival|Overall survival using the Kaplan-Meier method|Followed every 3 months after treatment is discontinued||||months||90% Confidence Interval|Median
2803522|NCT00499694|Secondary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels|Day 1 of every cycle (35 days) and Day 15 of every cycle||||pct. of pts. with 50%+ decrease in PSA||90% Confidence Interval|Number
2803523|NCT00499694|Secondary|Toxicity, Presented as the Number of Participants With Adverse Events|Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).|Day 1 of every cycle (35 days) and Day 15 of every cycle||||Participants|||Count of Participants
2803524|NCT00499694|Primary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.|Every 70 days||||months||90% Confidence Interval|Median
2803525|NCT00499681|Primary|Number of Participants With a Pathological Complete Response|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 14 weeks|Participants who were available for measurement of response.|||participants|||Number
2803526|NCT00499655|Secondary|Progression-free Survival - Low PGEM|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with low baseline urinary prostaglandin E metabolite (PGEM).|||Months||95% Confidence Interval|Median
2803527|NCT00499655|Secondary|Progression-free Survival - EGRF|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with wild-type epidermal growth factor receptor (EGFR),|||Months||95% Confidence Interval|Median
2803528|NCT00499655|Secondary|Progression-free Survival - Elevated PGEM|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|Analysis on a subset of patients with elevated baseline urinary prostaglandin E metabolite (PGEM).|||Months||95% Confidence Interval|Median
2803529|NCT00499655|Secondary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks post start of treatment||||Participants|||Count of Participants
2803530|NCT00499655|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Until disease progression, up to 5 years.|All patients receiving treatment.|||Months||95% Confidence Interval|Median
2803531|NCT00499616|Secondary|Image Defined Risk Factor (IDRF)|Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult.|At baseline|All eligible and evaluable patients enrolled on ANBL0531|||percentage of patients|||Number
2803532|NCT00499616|Secondary|Association Between Surgical Biopsy Technique With Adequacy of Tissue Acquisition for Biologic Studies, and With Complications Associated With the Biopsy Procedure|A chi-square test will be performed.|During and after surgery|The data was not collected to assess this study aim.||||||
2803533|NCT00499616|Secondary|Neurologic Symptoms|Percentage of patients with neurologic symptoms will be calculated. Includes patients with paraspinal or intraspinal tumors, including epidural tumors with or without spinal cord compression. Neurologic symptoms include back or extremities neurologic symptoms, motor deficit, abnormal sensation, abnormal bladder/bowel sphincteric function, chronic pain in back or extremities, scoliosis, kyphosis, or clinically relevant/functional abnormality in size or contour of leg or foot.|At baseline|All eligible and evaluable patients enrolled on ANBL0531|||percentage of patients|||Number
2803534|NCT00499616|Secondary|Biological Surrogate Markers|Multivariable analyses will be performed to identify variables of prognostic interest.|At baseline and surgery|The data was not collected to assess this study aim.||||||
2803535|NCT00499616|Secondary|Second-Overall Survival|OS (from the time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|From the time of the first progressive, non-metastatic event; up to 3 years|Eligible patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|||Percentage||95% Confidence Interval|Number
2803536|NCT00499616|Secondary|Second-event-free Survival (E2FS)|E2FS (from time of first event) will be calculated to describe the outcome for patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy.|From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse, progressive disease, secondary malignancy, or death; up to 3 years|Eligible patients who have a first progressive, non-metastatic event during Observation and then receive protocol retrieval therapy|||Percentage||95% Confidence Interval|Number
2803537|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate|To test for the association of the extent of surgical resection (CR vs <CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery|||Proportion with surgical complications||95% Confidence Interval|Number
2803538|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Overall Survival (OS) Rates|To test the predictive ability of the extent of surgical resection for OS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery.|||percentage of OS rate||95% Confidence Interval|Number
2803539|NCT00499616|Primary|Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)|To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.|Up to 10 years|Eligible and evaluable intermediate risk patients with reported surgery|||percentage of 3 yr EFS survival||95% Confidence Interval|Number
2803540|NCT00499616|Primary|Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment|Kaplan-Meier curves and lifetables of Event Free Survival (EFS) and Overall Survival (OS) rates will be generated to describe the outcome of the stage 4S infants unable to undergo biopsy.|From baseline to up to 10 years|Eligible and evaluable patients with Stage 4S neuroblastoma unable to undergo biopsy.|||percentage survival||95% Confidence Interval|Number
2803541|NCT00499616|Primary|Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma|Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.|Up to 3 years|Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.|||Proportion||95% Confidence Interval|Number
2803577|NCT00499252|Secondary|Overall Survival||from entry into the study to death or the date of last contact.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2803542|NCT00499616|Primary|Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961|Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age|Up to 3 years|Eligible and evaluable patients with Stage 3 neuroblastoma, 12-18 months of age, MYCN non-amplified, and unfavorable histology.|||percentage of 3 yr EFS rate|||Number
2803543|NCT00499616|Primary|Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961|Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients < 1 yrs of age.|Up to 3 years|Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.|||percentage of 3 yr EFS rate||95% Confidence Interval|Number
2803544|NCT00499616|Primary|Definitive Determination of the Prognostic Ability of 1p and 11q|Addressed by a descriptive comparison of the EFS and OS rates for patients with 1p loss vs without 1p loss, and for those with unbalanced 11q vs normal 11q.|At baseline|Eligible intermediate risk patients with 1p and 11q data.|||percentage of 3 yr EFS/OS rate||95% Confidence Interval|Number
2803545|NCT00499616|Primary|Overall Survival (OS) Rates|OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.|3 years|Eligible intermediate risk patients.|||percentage of participants||95% Confidence Interval|Number
2803546|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 24 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|24 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.|||participants|||Number
2803547|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 12 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|12 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.|||participants|||Number
2803548|NCT00499603|Primary|Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours|Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present.|48 hours after start of treatment|Participants were randomly assigned 1:1 to receive T-FEC or TR-FEC using a balanced block design stratified by disease stage and menopausal status. One participant in Arm 2 started treatment but had untolerable side effects and was taken off the study and thus was considered inevaluable.|||participants|||Number
2803549|NCT00499590|Secondary|Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision||Week 60|Zero participants analyzed due to early termination of the study.||||||
2803550|NCT00499590|Primary|Visual Acuity|avoidance of 3 or more lines of vision loss|week 60|Zero participants analyzed due to early termination of the study.||||||
2803551|NCT00499486|Primary|Severity of Adverse Events as Assessed by NCI CTCAE v3.0||6 months||||percentage of Adverse Events|||Number
2803552|NCT00499486|Primary|Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.|response at 2 and 6 months||||participants|||Number
2803553|NCT00499486|Primary|Percentage of Patients With Overall Survival at 6 Months||6- month survival rate (6mSR)||||% of participants|||Number
2803554|NCT00499473|Secondary|Overall Survival||up to 12 months||||months||Full Range|Median
2803555|NCT00499473|Secondary|Percentage of Patients Progression Free at 12 Months||At 12 months after the start of treatment||||percent of patients|||Number
2803556|NCT00499473|Secondary|Confirmed Objective Response (Complete Response[CR] or Partial Response [PR])|Confirmatory scans should also be obtained within 4 to 6 weeks following initial documentation of objective response. Confidence intervals for the true proportion will be calculated using the exact binomial method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 weeks|Only 21 patients were evaluable for response|||patients|||Number
2803612|NCT00498706|Secondary|Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)||Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up|||||||
2803558|NCT00499473|Primary|Maximum Tolerable Dose Based on Dose-limiting Toxicity of Sunitinib in Patients Receiving EIAC (Stratum 2)|Maximum tolerable dose of sunitinib in patients receiving treatment with EIAC agents using dose escalation based on the steady-state trough sunitinib + SU12662 plasma concentrations on day 14 observed in patients treated in stratum 1. Six patients will be treated in each dose cohort with up to 12 patients being treated at the maximum tolerable dose for a total of 18-24 patients with gliomas receiving EIAC.|From the time of first treatment with sunitinib until completion of treatment, assessed up to 30 days|MTD in Stratum 2 not determined due to lack of efficacy in Stratum 1||||||
2803559|NCT00499473|Primary|Progression-free Survival at 6 Months (Stratum 1)|Number of patients with Progression-free Survival at 6 months for Stratum 1|From time to registration to up to 6 months|Only 21 patients were evaluable for PFS|||patients|||Number
2803560|NCT00499460|Secondary|Oral Digoxin Test|Digoxin when given orally is a probe substrate for the efflux activity of P-glycoprotein in the small intestine. The phenotype index in this case is the area under the plasma digoxin concentration from time zero to 240 min after a 0.5-mg oral test dose. A decrease in oral digoxin AUC indicates an enhanced activity of P-glycoprotein, possibly as a result of transporter upregulation.|Serial blood sampling over 4 hours after a 0.5-mg oral test dose of digoxin||||(ng/mL)*min||Standard Deviation|Mean
2803561|NCT00499460|Secondary|Oral Midazolam Test|Midazolam when given orally is a probe substrate for the in vivo intestinal and hepatic activity of CYP3A (Cytochrome P450 3A) enzymes. The phenotype index in this case is the area under the plasma midazolam concentration from time zero to 360 min after a 5-mg oral test dose. A decrease in oral midazolam AUC indicates enhanced activity of CYP3A enzymes, possibly as a result of enzyme induction.|Serial blood sampling over 6 hours after a 5-mg oral test dose of midazolam||||(ng/mL)*min||Standard Deviation|Mean
2803562|NCT00499460|Secondary|Cognitive-Affective Side Effects Total Score|Subjects rated the mental side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 36-item Cognitive-Affective Side Effects (CASE) questionnaire. Total score (i.e., average of the scores for all 36 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak CASE scores at 150 min are reported herein.|CASE scores at 150 min after a single 15-mg oral dose of oxycodone||||units on a scale||Standard Deviation|Mean
2803563|NCT00499460|Secondary|Somatic Side Effects Total Score|Subjects rated the bodily side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 35-item Somatic Side Effects (SSE) questionnaire. Total score (i.e., average of the scores for all 35 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak SSE scores at 150 min are reported herein.|SSE scores at 150 min after a single 15-mg oral dose of oxycodone||||units on a scale||Standard Deviation|Mean
2803564|NCT00499460|Secondary|Cold Pressor Tolerance AUC|Cold Pressor Test measures response to experimentally induced pain, in this case by immersion of a subject's hand in icy-cold water. Tolerance is the duration of time a subject is able to keep his/her hand immersed in the cold water. A prolongation in tolerance time indicates analgesic response to oxycodone treatment. Cold Pressor Tolerance AUC is the area under the tolerance versus time curve over a 300-min period after a test dose of oxycodone. Because of non-normality in sample distribution, log transformed AUC estimates were analyzed by Generalized Linear Model.|Repeated testing for tolerance to Cold Pressor Test just before and at 45, 90, 150 and 300 min after a single 15-mg oral dose of oxycodone||||log (sec*min)||Standard Deviation|Mean
2803565|NCT00499460|Primary|Oxycodone Oral Clearance|Oxycodone oral clearance is computed by Dose/AUC, where AUC is the area under the plasma oxycodone concentration-time curve from time zero to infinity. Oral clearance is a measure of the rate at which oxycodone is cleared from the body via metabolism.|Serial blood sampling over 24 hours after a 15-mg oral dose of oxycodone||||L/min||Standard Deviation|Mean
2803566|NCT00499447|Primary|Two Year Progression Free Survival Rate|the number of patients surviving progression-free at two years.|2 years||||participants|||Number
2803567|NCT00499408|Secondary|Time to Progression|Progression will be defined as a 50% rise in serum PSA compared to the baseline value confirmed on at least two measurements at least two weeks apart.|up to three years|16 subjects progress out of the 23 evaluable for response.|||months||Full Range|Median
2803568|NCT00499408|Secondary|Number of Adverse Events, Grades 1-5|Toxicity will be graded according to the revised NCI Common Terminology Criteria for Adverse Events v 3.0, (CTCAE). Number of events with grade 1-5 will be reported.|up to one year||||events|||Number
2803569|NCT00499408|Secondary|Changes in PSA Doubling Time||up to one year|Data not collected||||||
2803570|NCT00499408|Secondary|Changes in PSA Slope||up to one year|Data not collected||||||
2803571|NCT00499408|Primary|Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment||up to one year|Only 23 participants evaluable for a response.|||participants|||Number
2803572|NCT00499369|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2803573|NCT00499369|Primary|Progression-free Survival (PFS)|PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 5 years|All eligible patients are included in this analysis.|||months||95% Confidence Interval|Median
2803574|NCT00499369|Secondary|Objective Tumor Response||Up to 5 years|No participants were analyzed due to limited accrual.||||||
2803575|NCT00499369|Secondary|Overall Survival|Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 5 years|No participants were analyzed due to limited accrual.||||||
2803576|NCT00499343|Primary|CD34+ Cells/kg in Blood Stem Cells|After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.|The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.||||CD34+ cells/kg||Full Range|Median
2803578|NCT00499252|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|from study entry until disease progression, death or date of last contact.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2803579|NCT00499252|Primary|Frequency and Severity of Observed Adverse Effects||Every cycle during treatment and up to 5 years after completion of treatment|Treated and Eligible patients|||Participants|||Count of Participants
2803580|NCT00499252|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels|Eligible and Treated Patients|||Percentage of participants||95% Confidence Interval|Number
2803581|NCT00499122|Secondary|Correlation Between Myeloid Derived Suppressor Cell (MDSC) Levels and Pathologic Complete Response (pCR) and Non-Responders|The investigators hypothesized that patients with favorable responses, i.e. pCR, are more likely to have significantly lower levels of MDSCs than non-responders. MDSC levels will be measured at baseline and on day 1 of each treatment cycle, cycles 1 through 8.|Baseline, Day 1 of Cycles 1 through 8, about 7 months|Study participants who were evaluable for pathologic response.|||MDSC/uL||Standard Error|Mean
2803582|NCT00499122|Secondary|Definition of the Safety Profiles of Protocol Therapy|Definition of the safety profiles of protocol therapy in study participants as shown by the number of study participants experiencing adverse events or other toxicity.|Up to 30 days Post-Last Dose of Protocol Therapy, About 7 months||||participants|||Number
2803583|NCT00499122|Primary|Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy|The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.|About 7 months|Assessable tumors from study participants who had received at least one cycle of protocol therapy.|||percentage of tumors|Tumors|95% Confidence Interval|Median
2803584|NCT00499109|Secondary|Response Rate (RR)|Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months|All evaluable participants|||participants|||Number
2803585|NCT00499109|Secondary|Overall Survival (OS)|OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival.|12 months|All participants|||estimated percentage of participants||95% Confidence Interval|Number
2803586|NCT00499109|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months.|6 months|All participants|||estimated percentage of participants||95% Confidence Interval|Number
2803587|NCT00499096|Secondary|Body Mass Index (BMI)|Body mass index (BMI) is reported in kilograms divided by meters squared (kg/m^2) with a normal (healthy) range of 18-24, in which >=25 is considered overweight, and >=30 is the definition of obesity|24 months||||kg/m^2||Standard Deviation|Mean
2803588|NCT00499096|Secondary|Disability Based on WHO-DAS Score|Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability|24 months||||units on a scale||Standard Deviation|Mean
2803589|NCT00499096|Secondary|Depressive Symptom Score|Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)|24 months||||units on a scale||Standard Deviation|Mean
2803590|NCT00499096|Primary|Physical Health-related Quality of Life Score|Physical health-related quality of life is based on the Short Form (SF)-12 survey physical health component (PCS) score- which ranges from 0 to 50, with higher scores indicating higher quality of life|24 months||||units on a scale||Standard Deviation|Mean
2803591|NCT00499096|Primary|Total Cholesterol|Total cholesterol in mg/dl- lower is better|24 months||||mg/dL||Standard Deviation|Mean
2803592|NCT00499096|Secondary|Manic Symptoms|Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)|24 months||||units on a scale||Standard Deviation|Mean
2803593|NCT00499096|Primary|Systolic and Diastolic Blood Pressure (SBP, DBP)|24-month systolic and diastolic blood pressure (mm/Hg): lower is better|24 months||||mm/Hg||Standard Deviation|Mean
2803594|NCT00499083|Secondary|Influence of Tumor COX-2 and VEGF Expression on Dendritic Cell-mediated Tumor-specific Immunity|T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.|Post-vaccination peripheral blood (PB) after the last chemotherapy.|Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.||||||
2803595|NCT00499083|Secondary|Antibody-dependent Cell-mediated Cytotoxicity|T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.|Post-vaccination peripheral blood (PB) after the last chemotherapy.|Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.||||||
2803596|NCT00499083|Secondary|Inflammatory Cell Infiltration|T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.|Post-vaccination peripheral blood (PB) after the last chemotherapy.|Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.||||||
2803597|NCT00499083|Primary|Number of Patients With Pathological Complete Response|"Assessed by the institutional pathologist.~Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs~Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs~Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis~Grade 4: no or few modifications of the tumor appearance"|At definitive surgery.||||participants|||Number
2803598|NCT00499031|Secondary|Duration of Overall Survival||From study entry to death or the date of last contact, up to 5 years|||||||
2803599|NCT00499031|Secondary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years|||||||
2803600|NCT00499031|Secondary|Duration of Objective Response Rate||Up to 5 years|||||||
2803601|NCT00499031|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, up to 5 years|||||||
2803602|NCT00499031|Primary|Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|every other cycle for the first 6 months; then every 3 months x 2; then every 6 months|Total number of eligible and evaluable participants|||participants|||Number
2803603|NCT00499031|Primary|Progression-free Survival Greater Than 6 Months||At 6 months|Total number of eligible and evaluable participants|||participants|||Number
2803604|NCT00498940|Secondary|Number of Subjects With Postoperative Complications|This is to measure the total number of subjects that experienced any of the following complications: sepsis/infection, renal failure, respiratory failure/complications, bleeding requiring reoperation, cerebrovascular accident.|30 days after surgery||||participants|||Number
2803605|NCT00498940|Primary|Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).|Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.|24 hours||||L/min/m^2||Standard Error|Mean
2803606|NCT00498927|Secondary|Overall Survival|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.|2 years|Glioblastoma patients|||months||95% Confidence Interval|Median
2803607|NCT00498927|Primary|Progression-free Survival (PFS) Rate at 6 Months|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months|Glioblastoma patients|||percentage of participants|||Number
2803608|NCT00498797|Secondary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)||||Participants|||Number
2803609|NCT00498797|Primary|Prostate Specific Antigen (PSA) Response|Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response|PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline||||Participants|||Number
2803610|NCT00498706|Primary|Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)|Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up||||units on a scale||Full Range|Mean
2803611|NCT00498706|Primary|Patient Health Questionnaire (PHQ)-9|Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up||||units on a scale||Full Range|Mean
2803613|NCT00498706|Primary|Number of Participants Who Dropped Out of Therapy|"Using the number of therapy sessions attended, we categorized patients into:~those who discontinued treatment before session 18, and those who completed session 18.~those who discontinued before Session 5, and those who continued."|Post treatment, up to 18 weeks||||participants|||Number
2803614|NCT00498706|Primary|Attrition (Number of Therapy Sessions Attended)|Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.|Post treatment, up to 18 weeks|A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.|||Number of Sessions|Participants|Standard Deviation|Mean
2803615|NCT00498628|Secondary|Quality of Life SF-12 - Physical Aggregate Score|The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status.|Week 12|mITT|||score on a scale||Standard Error|Least Squares Mean
2803616|NCT00498628|Secondary|Quality of Life SF - 12 - Mental Aggregate Score|The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status.|Week 12||||score on a scale||Standard Error|Least Squares Mean
2803617|NCT00498628|Secondary|Pittsburgh Sleep Quality Score|"The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); >6 indicative of poor sleep quality. The PSQI was assessed at study weeks 4,8, and 12. Analyses averaged across these weeks."|Weeks 4, 8, 12||||score||Standard Error|Least Squares Mean
2803618|NCT00498628|Secondary|Hamilton Anxiety Scale (HAM-A)|The Hamilton Anxiety Scale consists of 14 items, each defined by a series of symptoms. Similar to the HAM-D, each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) (Guy, 1976). A total score is derived from the summed items (min=0, max=56) with higher scores indicative of greater anxiety (a poor outcome). The HAM-A was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.|Weeks 4, 6, 8, 10, and 12||||score on a scale||Standard Error|Least Squares Mean
2803619|NCT00498628|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is the sum of the 10-item in a checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60. Higher scores are indicative of greater depressive symptoms (a poor outcome). The MADRS was assessed at weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.|Weeks 3-11||||score on a scale||Standard Error|Least Squares Mean
2803620|NCT00498628|Secondary|Penn Alcohol Craving Score (PACS_|The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). The summed total score of the 5 items was used in the analysis (min=0, max=30) with higher scores indicative of higher craving for alcohol (a poor outcome). Based on clinical study results, the PACS has been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse. The PACS was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks.|Weeks 4, 6, 8, 10, and 12||||score on a scale||Standard Error|Mean
2803621|NCT00498628|Secondary|Drinking Consequences Score|Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. We used a modified version of the DrInC that just included the 45-items that summed the Interpersonal, Physical, Social, and Impulsivity items. This total score (min=0, max=135) was analyzed in this study with high scores indicative of more alcohol-related consequences (a poor outcome for a given study participant). The DrInC was assessed at study weeks 6 and 12. Analyses averaged across these weeks.|Weeks 6 & 12||||score on a scale||Standard Error|Least Squares Mean
2803622|NCT00498628|Secondary|Percent Subjects With no Heavy Drinking Day|Timeline Follow Back data used to calculate the % of subjects that didn't have a heavy drinking day during study weeks 3-11.|Study Weeks 3-11||||Participants|||Count of Participants
2803623|NCT00498628|Secondary|Percent Subjects Abstinent|Timeline Follow Back data used to calculate the % of subjects that maintained abstinence weeks 3-11.|Study Weeks 3-11||||Participants|||Count of Participants
2803624|NCT00498628|Secondary|Percent Very Heavy Drinking Day|Timeline Follow Back data used to calculate the % of very heavy drinking days per week. Heavy drinking is 10+ drinks per day for females and 12+ drinks per day for males|Study Weeks 3-11||||percentage heavy drinking days||Standard Error|Least Squares Mean
2803625|NCT00498628|Secondary|Drinks Per Day|Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per day|Study Weeks 3-11||||drinks per day||Standard Error|Least Squares Mean
2803626|NCT00498628|Secondary|Drinks Per Drinking Day|Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day|Study Weeks 3-11||||drinks per drinking day||Standard Error|Least Squares Mean
2803629|NCT00498615|Primary|Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.|The time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes||||minutes||Standard Deviation|Mean
2803630|NCT00498615|Secondary|The Blood Flow by Laser Doppler Scans of the Fingers|The measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study.|Blood flow prior to cold challenge 2 hours after taking study drug||||perfusion units||Standard Deviation|Mean
2803631|NCT00498615|Primary|The Time to Recover 50% of Fall in the Baseline Skin Temperature.|The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes||||minutes||Standard Deviation|Mean
2803632|NCT00498602|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|||||||
2803633|NCT00498602|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
2803634|NCT00498602|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
2803635|NCT00498602|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose|The safety population included all randomized participants with documented use of at least one dose of study drug.|||percentage of participants|||Number
2803636|NCT00498550|Primary|Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy)|Intensity of cannabis use is obtained for each week retrospectively as the number of joints smoked during the prior week (assessed by the Timeline Followback Scale). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|Week 1 to week 12||||Joints per week||95% Confidence Interval|Number
2803637|NCT00498485|Primary|Self Reported Assessment of Sleep|Subjects were asked to provide their input as to the quality of their sleep over the past week|Assessed at week 6|While data were collected, these data were never analyzed because the study was terminated prematurely by the sponsor and were lost when PI moved from UMDNJ to Beth Israel in NYC in 2008.||||||
2803638|NCT00498485|Primary|Global Assessment of Change|A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 [much better] thru 0 [no change] to -2 [much worse]|6 weeks|Had we completed the study, the analysis would have been a comparison of counts of those reporting being very much improved across the two treatment conditions|||participants|||Number
2803639|NCT00498433|Secondary|Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death||98 days|The safety population consisted of all patients who received at least one dose of study drug with at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Participants|||Number
2803640|NCT00498433|Secondary|Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803641|NCT00498433|Secondary|Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803642|NCT00498433|Primary|Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803643|NCT00498433|Primary|Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803644|NCT00498433|Primary|Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period|Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803645|NCT00498433|Primary|Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803646|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Amlodipine Treatment Period|Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||ng/nl/h||95% Confidence Interval|Geometric Mean
2803647|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Aliskiren Treatment Period|Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||ng/nl/h||95% Confidence Interval|Geometric Mean
2803648|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period|Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||pg/mL||95% Confidence Interval|Geometric Mean
2803649|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period|Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||pg/mL||95% Confidence Interval|Geometric Mean
2803650|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||fmol/mL||95% Confidence Interval|Geometric Mean
2803651|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.|||fmol/mL||95% Confidence Interval|Geometric Mean
2803652|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.|||ng/mL||Standard Deviation|Mean
2803653|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.|||ng/mL||Standard Deviation|Mean
2803654|NCT00498433|Primary|Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period||Day 42|Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points.||||||
2803655|NCT00498433|Primary|Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.|Day 42|More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received.||||||
2803656|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.|||ng/g||Standard Deviation|Mean
2803657|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|Due to technical limitations, zero flow concentrations could not be derived for Ang II.||||||
2803658|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|Due to technical limitations, zero flow concentrations could not be derived for Ang II.||||||
2803659|NCT00498433|Secondary|Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803660|NCT00498433|Secondary|Part 2: Change From Baseline in Official Blood Pressure||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803661|NCT00498433|Secondary|Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Day 14 and Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
2803662|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).|Day 98|Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes.||||||
2803663|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis.|||ng/mL||Standard Deviation|Mean
2803664|NCT00498368|Secondary|Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||U/ml||Standard Deviation|Mean
2803665|NCT00498368|Secondary|Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||U/100ng IgA||Standard Deviation|Mean
2803666|NCT00498368|Secondary|Biochemical Marker IgA at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||mg/ml||Standard Deviation|Mean
2803667|NCT00498368|Primary|Change in Proteinuria at 12 Months||1 year|The number of participants differs from the participant flow because not all participants had the laboratory test done.|||participants|||Number
2803668|NCT00498355|Secondary|The Incidence of Ocular and Non-ocular Adverse Events||Study duration||||adverse events|||Number
2803669|NCT00498355|Secondary|The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)||Study duration||||uveitis flares|||Number
2803670|NCT00498355|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12||7 days, and at months 3, 6, 9, and 12||||microns||Full Range|Mean
2803671|NCT00498355|Secondary|The Median Change in Best Corrected Visual Acuity From 6 to12 Months||6 to 12 months||||Letters||Full Range|Median
2803672|NCT00498355|Primary|The Mean Change at 3 Months in BSCVA From Baseline|The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.|baseline and 3 months|6 patients completed all assessment points. One patient decided not to continue for nonmedical reasons, but they did complete the baseline, 1-week and 1-month assessment.|||letters||Full Range|Mean
2803673|NCT00498186|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).|||participants|||Number
2803674|NCT00498186|Primary|Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).|||participants|||Number
2803675|NCT00498173|Secondary|Change in Pediatric Anxiety Rating Scale, 5-item Total (Open-label Trial)|Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms.Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
2803700|NCT00497796|Secondary|Number of Participants With Acute Graft Rejection|Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score.|26 weeks post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.|||participants|||Number
2803676|NCT00498173|Secondary|Change in Pediatric Quality of Life Inventory (Open-label Trial)|Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at the start of the open-label trial and at the end of 8 weeks. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
2803677|NCT00498173|Secondary|Change in Vineland Adaptive Behavior Scales (VABS) Composite Score (Open-label Trial)|The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Change will be determined from the start of the open-label phase to 8 weeks|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
2803678|NCT00498173|Secondary|Change in Social Responsiveness Scale (SRS) (Open-label Trial)|The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. This 65-item questionnaire will be completed at the start of and at the end of 8 weeks of the open-label trial.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
2803679|NCT00498173|Secondary|Change in Aberrant Behavior Checklist (ABC) (Open-label Trial)|The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Placebo-treated subjects that don’t respond to placebo will be offered an 8-week open-label trial of atomoxetine, and the open-label extension will be a continuation phase for those subjects that respond to 8 weeks of atomoxetine during the double-blind phase.|||units on a scale||95% Confidence Interval|Mean
2803680|NCT00498173|Secondary|Change in ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Open-label Trial)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week open-label phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score fro each subscale ranges from 0-27, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
2803681|NCT00498173|Secondary|Change in ADHD Rating Scale (ADHDRS)-Home Version Total Score (Open-label Trial)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Change will be determined from the start of the open-label trial to 8 weeks post-start.|8 weeks|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial|||units on a scale||95% Confidence Interval|Mean
2803697|NCT00497796|Secondary|Plasma Concentration of Maribavir During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The Pharmacokinetic (PK) population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
2803682|NCT00498173|Secondary|Odds of Clinical Global Impression-Improvement Scale, Very Much or Much Improved (1 or 2) (Randomized Phase)|The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds of improvement at 8 weeks were estimated using a repeated measures logistic regression model adjusting for baseline severity, study stratum, and site. The CGI-I was administered biweekly during the study. The CGI was focused on the target symptoms of inattention, hyperactivity, and impulsivity.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||odds of improvement||95% Confidence Interval|Number
2803683|NCT00498173|Secondary|Pediatric Anxiety Rating Scale, 5-Item Total (Randomized Phase)|Since the ABC does not have items which directly assess anxiety, the Pediatric Anxiety Rating Scale (PARS) is administered at week 8 during the study as an exploratory measure. The PARS is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803684|NCT00498173|Secondary|Pediatric Quality of Life Inventory (Randomized Phase)|Quality of life is assessed with the Pediatric Quality of Life Inventory (PedsQL 4.0). This instrument is well-validated and widely used for measuring health-related quality of life in children and adolescents. It also appears to be a valid instrument for use with children with psychiatric disorders. The Generic Core scales include 23 items. The health related and family functioning scores range from 0 to 100, with higher scores indicating better quality of life. The Family Impact module will be included to assess any change in family functioning. This will be completed at baseline and at the end of 8 weeks. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803685|NCT00498173|Secondary|Vineland Adaptive Behavior Scales (VABS) Composite Score (Randomized Phase)|The Vineland Adaptive Behavior Scales, Second Edition (VABS) is used to assess adaptive functioning in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. This is a well-standardized open-ended interview used to assess the overall functioning of children and adults. This measure is especially important for subjects with PDDs given that their intellectual level is not always comparable to their adaptive functioning. The Vineland Maladaptive Behavior subscales will be included with these measures as these have been shown to be responsive to drug effects in other clinical trials in this population. The VABS will be done at baseline and at the end of 8 weeks. The composite score represents a standard score (mean = 100 and standard deviation of 15; range = 20-160) on which higher scores indicate a higher level of adaptive functioning. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803686|NCT00498173|Secondary|Social Responsiveness Scale (SRS) (Randomized Phase)|The Social Responsiveness Scale (SRS) is completed by the parent in order to assess whether additional improvements in social functioning occur with atomoxetine, as observed in our pilot study. This 65-item questionnaire will be completed at baseline and at the end of 8 weeks. The SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each item is summed to create a total score. Total score results as follows: 0-62: within normal limits; 63-79 mild range of impairment; 80-108: moderate range of impairment; 109-149: severe range of impairment. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Four participants from the Atomoxetine arm, and two participants from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803687|NCT00498173|Secondary|Aberrant Behavior Checklist (ABC) (Randomized Phase)|The Aberrant Behavior Checklist (ABC) is a 58-item questionnaire with 5 subscales derived by factor analysis: Irritability, Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate. It has been extensively used in psychopharmacological studies of autism and assesses many symptoms that are either central to autism (Social Withdrawal, Stereotypy, and Inappropriate Speech) or frequently a target of treatment (Irritability). Each item of the 58-item scale is scored on a 4-point scale (0=never a problem to 3=severe problem). The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores per subscale are: Social Withdrawal/Lethargy 0-48; Stereotypy 0-21; Irritability 0-45; Hyperactivity 0-48; Inappropriate Speech 0-12. Parent ratings occur every 2 weeks during the study. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803688|NCT00498173|Secondary|ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Randomized Phase)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The score for each subscale ranges from 0-27 with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803701|NCT00497796|Secondary|Number of Participants With Graft Failure Related Death||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-S population, defined as all participants who received at least one dose of study drug.|||participants|||Number
2803689|NCT00498173|Primary|ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase)|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD-RS-IV is investigator-administered biweekly during the 8-week double-blind, placebo-controlled phase of the study. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range form 0 to 54, with a higher score indicating greater severity. Estimates are adjusted for baseline score, study stratum, and site, which were set at their sample means.|8 weeks|Two participants from the Atomoxetine arm, and one participant from the Placebo arm did not have post-baseline measures.|||units on a scale||95% Confidence Interval|Mean
2803690|NCT00497874|Secondary|Change in Physical Functioning|Physical functioning was assessed using the Physical Functioning, Role Functioning, Health Perceptions, and Pain subscales of the 20-item Medical Outcomes Study Short Form survey (SF-20) (Stewart, Hays, & Ware, Jr., 1988). (SF-20 subscales assessing mental health and social functioning were omitted to get a purer measure of physical functioning). Physical functioning was computed by taking the mean of the four subscales after each was linearly transformed to range from 0-100. The change scores reported here are the difference between the physical functioning scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -100 to +100, with higher positive scores indicating more improvement in physical functioning.|Baseline, 9 months|Multiple imputation|||units on a scale||Standard Deviation|Mean
2803691|NCT00497874|Secondary|Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)|At 9 months follow-up, participants who had been prescribed antidepressant medication were asked if they had started and were still taking it. Participants who were taking their medication or had stopped with their doctor's advice were considered to be adherent.|9 months|Multiple imputation|||Participants|||Number
2803692|NCT00497874|Secondary|Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up|At baseline and follow-up, Major Depression was assessed using 9-item depression module of the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire—PHQ-9 (Spitzer, Kroenke, & Williams, 1999). In this analysis, Major Depression was assessed among participants not meeting criteria for major depression at baseline.|9 months|Multiple imputation|||Participants|||Number
2803693|NCT00497874|Secondary|Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.|"Depression prevention was defined as: Using effective methods to keep depression from occurring, or if it does occur, to keep it as mild and brief as possible. Effective methods were: 1) controlling negative thinking; 2) engaging in healthy, pleasant activities; 3) practicing stress management; 4) exercising; and 5) getting professional help when needed. Patients who reported that they were not currently practicing depression prevention and had no intention of doing so in the next 6 months were classified in the precontemplation stage; those who intended to practice depression prevention in the next 6 months or next 30 days were classified in the contemplation or preparation stage, respectively; those who had been practicing depression prevention for less than 6 months were in the action stage, and those who had been practicing for more than 6 months were in maintenance. This outcome represents the number of participants in the action or maintenance stage at 9 months follow-up."|9 months|Multiple imputation|||Participants|||Number
2803694|NCT00497874|Secondary|Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity|Two statistical criteria (Jacobson & Truax, 1991a; Atkins, Bedics, McGlinchey, & Beauchaine, 2005) were used to define reliable and clinically significant improvement. The first involved selecting a cutoff that represents remission or the absence of symptoms, which was selected to be BDI-II < 9. The second involved selecting a pre-post difference score that represents a statistically reliable change (e.g., how much change—1 point, 5 points, 10 points—is needed to be 95% confident that a real change has occurred, rather than just a chance fluctuation due to the unreliability of the measure?) Using a general formula for calculating reliable change that incorporates test-retest reliability (Jacobson & Truax, 1991b), reliable change for the BDI-II was calculated to be 5.13, and rounded down to 5. Thus, reliable and clinically significant improvement on the BDI-II was defined as a reduction of 5 or more points from baseline to follow-up and a follow-up score < 9.|9 months|Multiple imputation|||Participants|||Number
2803695|NCT00497874|Primary|Change in Depression Severity|Depression was assessed using the Beck Depression Inventory, 2nd Edition (BDI-II)(Beck, Steer, & Brown, 1996). In this self-report measure, 21 symptoms of depression are rated on a 0-3 scale. Scores for the 21 items are summed to yield a total score ranging from 0 to 63. The change scores reported here are the difference between the total BDI-II scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -63 to +63, with larger negative scores indicating greater reduction in depression.|Baseline, 9 months|Multiple imputation|||units on a scale||Standard Deviation|Mean
2803696|NCT00497796|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The PK population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
2803698|NCT00497796|Secondary|Percent of Participants With Signs of Bone Marrow Suppression|Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) <1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period.|15 weeks|The ITT-S population, defined as all participants who received at least one dose of study drug.|||percent of participants|||Number
2803702|NCT00497796|Secondary|Number of Participants With Retransplantation||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug.|||participants|||Number
2803703|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
2803704|NCT00497796|Secondary|Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
2803705|NCT00497796|Secondary|Number of Participants With Investigator-determined CMV Disease|Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
2803706|NCT00497796|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||days||Inter-Quartile Range|Median
2803707|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||participants|||Number
2803708|NCT00497796|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The modified Intent-to-Treat (ITT-M) population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.|||number of participants with event|||Number
2803709|NCT00497770|Secondary|Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)|The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.|Baseline and end of treatment (up to 20 cycles [14 months])|The number of participants who had measurements for the subscale at those time points.|||participants||Standard Deviation|Mean
2803710|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone|The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803711|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping|The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803712|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications|The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803713|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities|The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803714|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances|The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803715|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation|The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803716|NCT00497770|Secondary|Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals|The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.|||percentage of participants|||Number
2803717|NCT00497770|Secondary|Progression Free Survival|Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.|baseline to measured progressive disease or death (up to 20 cycles [14 months])|All participants enrolled in the study.|||months||95% Confidence Interval|Median
2803718|NCT00497770|Secondary|Overall Survival|Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 20 cycles [14 months])|All participants enrolled in the study.|||months||95% Confidence Interval|Median
2803719|NCT00497770|Primary|Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)|Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.|baseline to measured progressive disease (up to 20 cycles [14 months])|"Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating Not done/Missing and were not included in this analysis."|||percentage of participants|||Number
2803720|NCT00497198|Primary|Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward|||percentage||Standard Error|Mean
2803721|NCT00497198|Primary|Hemoglobin A1c (HbA1c) at Baseline||0 weeks|Per protocol set|||percentage||Standard Deviation|Mean
2803722|NCT00497198|Primary|Change From Baseline in Blood Glucose at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward|||mg/dL||Standard Error|Mean
2803723|NCT00497198|Primary|Fasting Plasma Glucose at Baseline||0 weeks|Per protocol set|||mg/dL||Standard Deviation|Mean
2803724|NCT00497198|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12||12 weeks (baseline to week 12)||||mg/dL||Standard Error|Mean
2803725|NCT00497146|Secondary|Change in Progression of Left Ventricular Ejection Fraction|Change from baseline to Week 48 in left ventricular ejection fraction.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||percent||Standard Error|Least Squares Mean
2803759|NCT00496860|Secondary|ALT-801 Induced Cell-mediated Immune Responses|Number of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing|24 months||||IFNg spots per million PMBCs||Standard Error|Mean
2803726|NCT00497146|Secondary|Change in Progression of Left Ventricular End-diastolic Volume Index|Change from baseline to Week 48 in left ventricular end-diastolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters/meter^2.7||Standard Error|Least Squares Mean
2803727|NCT00497146|Secondary|Change in Progression of Left Ventricular End-systolic Volume Index|Change from baseline to Week 48 in left ventricular end-systolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters/meter^2.7||Standard Error|Least Squares Mean
2803728|NCT00497146|Secondary|Change in Progression of Aortic Compliance|Change from baseline to Week 48 in aortic compliance.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||10^-4 cm^2/mmHg||Standard Error|Least Squares Mean
2803729|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Wall Volume|Change from baseline to Week 48 in thoraco-abdominal aortic wall volume|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters||Standard Error|Least Squares Mean
2803730|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Plaque Volume|Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters||Standard Error|Least Squares Mean
2803731|NCT00497146|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milligrams/liter||Standard Error|Least Squares Mean
2803732|NCT00497146|Secondary|Change in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||log nanograms/liter||Standard Error|Least Squares Mean
2803733|NCT00497146|Secondary|Change in Troponin-T|Troponin-T is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||micrograms/liter||Standard Error|Least Squares Mean
2803734|NCT00497146|Secondary|Change in Interleukin-6 (IL-6)|Interleukin-6 (IL-6) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||nanograms/liter||Standard Error|Least Squares Mean
2803735|NCT00497146|Secondary|Change in Plasma Triiodothyronine (T3)|Plasma triiodothyronine (T3) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||nanomoles/liter||Standard Error|Least Squares Mean
2803736|NCT00497146|Secondary|Change in Left Atrial Volume|Left atrial volume is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||milliliters||Standard Error|Least Squares Mean
2803737|NCT00497146|Secondary|Change in Isovolumetric Relaxation Time (IVRT)|Isovolumetric relaxation time (IVRT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||seconds||Standard Error|Least Squares Mean
2803738|NCT00497146|Secondary|Change in E-wave Deceleration Time (DT)|E-wave deceleration time (DT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||seconds||Standard Error|Least Squares Mean
2803739|NCT00497146|Secondary|Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')|The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||ratio||Standard Error|Least Squares Mean
2803740|NCT00497146|Secondary|Change in Diastolic Mitral Annular Relaxation Velocity (E')|Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.|||centimeters/second||Standard Error|Least Squares Mean
2803741|NCT00497146|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.|Baseline to 48 weeks|The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.|||grams/meter^2.7||Standard Error|Least Squares Mean
2803742|NCT00497081|Primary|Frequency of Adverse Events Reported||From Baseline (week 0) through Final Visit (week 12)||||Adverse Events Reported|||Number
2803743|NCT00497081|Primary|Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.|Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).|Daily, from Baseline (week 0) through Final Visit (week 12)||||Percentage of recorded openings||Standard Deviation|Mean
2803744|NCT00497081|Primary|Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).||Baseline (week 0) and Final Visit (week 12)||||Percentage reduction|||Number
2803745|NCT00497055|Primary|To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.||Total reported adverse events (throughout study, up to 12 weeks)||||total reported adverse events|||Number
2803746|NCT00497055|Primary|To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.|To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps [MEMS or Medication Event Monitoring System]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.)|Adherence as determined by MEMS (throughout study, up to 12 weeks)||||percent adherence from MEMS||Standard Deviation|Mean
2803776|NCT00496782|Secondary|Change in Lymphocyte Subsets; CD4 and CD8 From Screening.|Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening}|Screening (Day -14 to 0), Day 1.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803747|NCT00497055|Primary|To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.|To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.|Final study visit at week 12||||perc of positive urines at final visit|||Number
2803748|NCT00496964|Secondary|Muscle Activation During Maximal Contractions and Fatigue Contractions|muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees|4, 6, 12 weeks||||ratio VMO EMG to VL EMG||Standard Deviation|Mean
2803749|NCT00496964|Secondary|Knee Extensor Fatigue|This is not available due to data collection errors|4, 6, 12 weeks|This is not available due to data collection errors||||||
2803750|NCT00496964|Secondary|Maximal Knee Extensor Force During Concentric and Isometric Contractions||4, 6, 12 weeks||||Nm||Standard Deviation|Mean
2803751|NCT00496964|Primary|Lower Extremity Functional Scale|The lower extremity functional scale (LEFS) is a self report questionnaire. Subjects rate 19 items related to general activities that require the lower extremities on a scale of 0 - 4. 0 = extreme difficulty or unable to perform the activity, 4 = No difficulty performing the activity. The total of all rankings are summed and divided by the maximum score (76). The score is reported as a percentage. 100% = no difficulty in performing any of the tasks. 0% = extreme difficulty or unable to perform all of the tasks.|4, 6, 12 weeks|No statistical analysis due to small number of subjects|||percentage of total possible score||Standard Deviation|Mean
2803752|NCT00496964|Primary|Functional Index Questionnaire|The Functional Index Questionnaire (FIQ) is a self report functional rating scale. Individuals rate eight-activities. Each activity is rated from 0 - 2 with ) being unable to perform the activity and 2 being able to perform the activity without difficulty. The total score is summed for a final score of 0 - 16. 0 indicates that the individual is ubable to perform any of the tasks, 16 indicates that the subject is able to perform all tasks without difficulty. The eight items include: walking (1 block and 1 mile), climbing stairs (2 flights and 4 flights), squatting, kneeling, prolonged sitting, and running|4, 6, 12 weeks|No statistical analysis due to small number of subjects|||units on a scale||Standard Deviation|Mean
2803753|NCT00496964|Primary|Change in Anterior Knee Pain Scale.|"Anterior Knee Pain Scale: a 13-item questionnaire; a TOTAL score of 0 = severe disability; a score of 100 = no pain or disability. (items are scored 0-5 or 0-10).~Change scores at 12 wks are reported. Inverted so positive values reflect improvement.~Included items: difficulty with: weight bearing, walking, stairs, squat, run, jump, prolonged sitting; presence of limp, swelling, patellar subluxation, atrophy of thigh, reduced knee flexion. Reference: Kujala et al: Scoring of Patellofemoral Disorders. J Arthroscopic Rel Surg, 9(2)159-163, 1993"|4, 6, 12 weeks|The Anterior Knee Pain Scale is a 13-item questionnaire; a score of 0 = severe disability; a score of 100 = no pain or disability. Change scores are reported. Positive values = improvement in symptoms.|||Units on Scale||Standard Deviation|Mean
2803754|NCT00496964|Primary|Visual Analog Scale Pain Ratings (VAS)|Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)|4, 6, 12 weeks|analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 12 weeks.|||cm||Standard Deviation|Mean
2803755|NCT00496873|Secondary|3-Year Progression-Free Survival|Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS.|PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
2803756|NCT00496873|Primary|Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy|Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.|9 cycles of 21 days, up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.|||participants|||Number
2803757|NCT00496873|Primary|Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999|Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.|Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.|||Percentage of Participants|||Number
2803758|NCT00496860|Secondary|Immunogenicity of ALT-801|Titer of anti-drug Abs at week 4|24 months||||titer||Standard Error|Mean
2803760|NCT00496860|Secondary|Clinical Antitumor Response to ALT-801|Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.|24 months||||participants|||Number
2803761|NCT00496860|Primary|The Maximum-tolerated Dose (MTD) of ALT-801|Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.|18 months||||events|||Number
2803762|NCT00496860|Primary|The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies|Number of serious adverse events per cohort|18 months||||Events|||Number
2803763|NCT00496834|Secondary|Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.|||mm Hg||Standard Deviation|Mean
2803764|NCT00496834|Secondary|Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.|||mm Hg||Standard Deviation|Mean
2803765|NCT00496834|Primary|PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.|Baseline and 24 Weeks|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.|||meters/second||Standard Deviation|Mean
2803766|NCT00496834|Primary|Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the modified intention to treat (mITT) population.|Baseline and 24 Weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique.|||meters/second||Standard Deviation|Mean
2803767|NCT00496808|Secondary|Mean Percent of Ki-67|Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.|||Percentage of Ki-67||Standard Deviation|Mean
2803768|NCT00496808|Primary|Number of Participants Achieving Documented Change in Proliferation|Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.|||Participants|||Number
2803769|NCT00496808|Primary|Percent Change in Proliferation as Measured by Ki-67|Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.|Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks|||||||
2803770|NCT00496782|Secondary|Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc||Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803771|NCT00496782|Secondary|Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24|Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24|Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803772|NCT00496782|Secondary|Number of Subjects With Susceptibility to Maraviroc|Phenotypic susceptibility to maraviroc|Screening (Day -21 to 0), Day 14, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803773|NCT00496782|Secondary|Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening|Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening|Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803774|NCT00496782|Secondary|Change in Detectable Tropism From Baseline|Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation|Baseline, Day 15 and Week 24/End of Study/Discontinuation|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803775|NCT00496782|Secondary|Change in Detectable Tropism From Screening|Number of subjects who switch their tropism status from screening to Baseline|Screening (Day -21 to 0), Baseline.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803778|NCT00496782|Primary|Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay|Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism|Baseline, Day 4, 7, 14|Study was canceled: no efficacy data (primary/secondary) was collected per protocol for limited number of patients left in study; only safety data was summarized.||||||
2803779|NCT00496782|Secondary|Change in Lymphocyte Subset CD4 From Baseline|Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1|Day 1 (Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803780|NCT00496782|Secondary|Time to Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803781|NCT00496782|Secondary|Subjects With Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803782|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <50 Copies/mL|Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803783|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <400 Copies/mL|Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||||||
2803784|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable|||Participants|||Number
2803785|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable|||Participants|||Number
2803786|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality|BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable|||Participants|||Number
2803787|NCT00496769|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug.|||Participants|||Number
2803788|NCT00496769|Secondary|Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
2803789|NCT00496769|Secondary|Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period|Event rate=percent of participants with an event divided by the total participants in the arm.|First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
2803790|NCT00496769|Secondary|Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
2803791|NCT00496769|Secondary|Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events per year|||Number
2803792|NCT00496769|Primary|Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.|||Percentage of events|||Number
2803793|NCT00496756|Secondary|Response Rate|The proportion of subjects with an objective response of complete or partial based on the RECIST Criteria|from the start of the treatment until disease progression/recurrence|Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.||||||
2803794|NCT00496756|Primary|Toxicity of Intrapatient Dose Escalation of Sorafenib Tosylate|To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.|Study completion|Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.||||||
2803795|NCT00496730|Other Pre-specified|Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.||Baseline and Week 8|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||mg/dL||Standard Deviation|Mean
2803796|NCT00496730|Secondary|Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.|"Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.~LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk)."|Baseline and 8 weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||Participants attaining LDL-C goal|||Number
2803797|NCT00496730|Primary|Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.||Baseline and 8 Weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||Percent of Baseline Value||Standard Deviation|Mean
2803798|NCT00496626|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all participants who were vaccinated at least one dose and had safety follow-up data|||Participants|||Number
2803799|NCT00496626|Secondary|Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7|"Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.~Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.|||Participants|||Number
2804381|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||Percentage of participants||95% Confidence Interval|Mean
2803800|NCT00496626|Primary|Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)|"Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.~The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) <7, <8, <11, <10 respectively)"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.|||mMU/mL||95% Confidence Interval|Geometric Mean
2803801|NCT00496587|Secondary|Objective Response Rate (ORR)|Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started.|12 months or until progression of disease|Four participants were excluded from response analysis due to missing data.|||percentage of participants|||Number
2803802|NCT00496587|Primary|Time to Treatment Failure (TTF)|Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.|12 months or until progression of disease|Four participants were excluded from response analysis due to missing data.|||Months||95% Confidence Interval|Median
2803803|NCT00496587|Primary|Progression Free Survival (PFS)|Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline.|12 months or until progression of disease|One participant was excluded from survival analysis due to missing data.|||Months||95% Confidence Interval|Median
2803804|NCT00496483|Secondary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.|||participants|||Number
2803805|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.|Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~Arithmetic mean and standard deviation is given below."|||percentage||Standard Deviation|Mean
2803806|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.|Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.|||hour||Full Range|Mean
2803807|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.|Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
2803808|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."|||ng*hr/mL||Standard Deviation|Mean
2803809|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
2803810|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."|||ng*hr/mL||Standard Deviation|Mean
2803811|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
2803812|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.|Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~Arithmetic mean and standard deviation is given below."|||percentage||Standard Deviation|Mean
2803813|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.|Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.|||hour||Full Range|Mean
2803814|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.|Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."|||ng/mL||Standard Deviation|Mean
2803815|NCT00496470|Secondary|Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803816|NCT00496470|Secondary|Serum Tumor Necrosis Factor-alpha (TNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803817|NCT00496470|Secondary|Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803818|NCT00496470|Secondary|Serum Monocyte Chemoattractant Protein-1 (MCP-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803819|NCT00496470|Secondary|Serum Interleukin 8 (IL-8)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803820|NCT00496470|Secondary|Serum Interleukin 6 (IL-6)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803821|NCT00496470|Secondary|Serum High-sensitivity C-reactive Protein (hsCRP)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Ratio||Inter-Quartile Range|Median
2803822|NCT00496470|Secondary|Severe COPD Exacerbations|Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation|12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Participants|||Number
2803823|NCT00496470|Secondary|COPD Symptoms, Cough Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
2803824|NCT00496470|Secondary|COPD Symptoms, Chest Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
2803825|NCT00496470|Secondary|COPD Symptoms, Sleeping Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
2803826|NCT00496470|Secondary|COPD Symptoms, Breathing Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Units on a Scale||Standard Deviation|Mean
2803827|NCT00496470|Secondary|Use of Rescue Medication, Total|Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
2803828|NCT00496470|Secondary|Use of Rescue Medication, Day|Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
2803829|NCT00496470|Secondary|Use of Rescue Medication, Morning|Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
2803859|NCT00496340|Secondary|Percentage of Participants With Overall Survival (OS)|OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.|2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2803830|NCT00496470|Secondary|Use of Rescue Medication, Night|Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Inhalations||Standard Deviation|Mean
2803831|NCT00496470|Secondary|Capacity of Day Living in the Morning (CDLM) Score|"Daily diary record. Change in average values from run-in to the full treatment period.~The CDLM questionnaire is as a questionnaire to report on patient's ability to carry out each of six different morning activities (score ranging from 0 not performed to 1performed) and rank the difficulty of performing each of those activities (score ranging from 0 so difficult that the activity could not be carried out by the patient on their own to 5 activity was not at all difficult to carry out. Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2803832|NCT00496470|Secondary|GCSQ Score, 15 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
2803833|NCT00496470|Secondary|GCSQ Score, 5 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2803834|NCT00496470|Secondary|Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
2803835|NCT00496470|Secondary|Morning Diary FEV1, 15 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803836|NCT00496470|Secondary|Morning Diary FEV1, 5 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803837|NCT00496470|Secondary|Evening Diary FEV1, Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803838|NCT00496470|Secondary|Morning Diary FEV1 Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803839|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 15 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
2803840|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 5 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
2803841|NCT00496470|Secondary|Evening Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
2803842|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
2803860|NCT00496340|Secondary|Percentage of Participants With Progression Free Survival (PFS)|PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., >5% blast in bone marrow or any peripheral blasts).|2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2803843|NCT00496470|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score|"Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).~SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life."|Baseline and 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Score on a scale||Standard Deviation|Mean
2803844|NCT00496470|Secondary|Inspiratory Capacity (IC) 60 Minutes Post-dose|Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803845|NCT00496470|Secondary|Inspiratory Capacity (IC) Pre-dose|Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803846|NCT00496470|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803847|NCT00496470|Secondary|Forced Vital Capacity (FVC) 5 Minutes Post-dose|Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803848|NCT00496470|Secondary|Forced Vital Capacity (FVC) Pre-dose|Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803849|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose|Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803850|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose|Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803851|NCT00496470|Primary|Forced Expiratory Volume in 1 Second (FEV1) Pre-dose|Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
2803852|NCT00496379|Secondary|Clinical Benefit Rate.|CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease|2 years|all pts who received at least 1 dose of protocol therapy|||percentage of participants|||Number
2803853|NCT00496379|Secondary|Time to Progression at Any Site.|Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0|2 years|all patients who received at least 1 dose of protocol therapy|||months||Full Range|Median
2803854|NCT00496379|Secondary|Objective Response Rate in Non-Central Nervous System (CNS) Sites|Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease|2 years|only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint|||percentage of participants|||Number
2803855|NCT00496379|Secondary|Number of Subjects With Adverse Events (Any Grade)|Adverse events per NCI CTCAE|2 years|Study was closed prior to full accrual for reasons detailed in published manuscript|||participants|||Number
2803856|NCT00496379|Primary|Objective Response Rate in the Central Nervous System (CNS)|Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.|2 years|The study was closed prior to full accrual as detailed in the manuscript|||percentage of participants||95% Confidence Interval|Number
2803857|NCT00496366|Secondary|-Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall||2 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
2803858|NCT00496366|Primary|Determine the Response Rate (as Determined by RECIST Criteria) of Capecitabine and Lapatinib as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer That Overexpress HER2.||2 years|Study to was terminated early and insufficient data was collected to assess this outcome measure.||||||
2803861|NCT00496340|Secondary|Incidence of Graft Versus Host Disease (GVHD)|"By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4.~At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD.~At 2 years, the cumulative incidence of moderate/severe chronic GVHD."|Up to 2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2803862|NCT00496340|Secondary|Time to Incidence of Graft Versus Host Disease (GVHD)|"The median time from allo-HCT to the initiation of tacrolimus (TAC) taper.~The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration."|Up to 2 years post-transplant|All participants|||days||95% Confidence Interval|Median
2803863|NCT00496340|Secondary|Incidence of Infections|Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.|Up to 2 years post-transplant|All participants|||participants|||Number
2803864|NCT00496340|Secondary|Non-relapse Mortality Rate (NRM)|The cumulative incidence of NRM after allo-HCT.|Up to 2 years post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2803865|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100|Median Percentage of Donor Cells in Study Population (Chimerism).|100 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.|||percentage of cells||95% Confidence Interval|Median
2803866|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28|Median Percentage of Donor Cells in Study Population (Chimerism).|28 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.|||percentage of cells||95% Confidence Interval|Median
2803867|NCT00496340|Secondary|Cumulative Incidence of Hematopoietic Cell Engraftment|Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) >/= 500/µl for 3 consecutive days or a platelet count of >/= 20,000//µl without the need for platelet support.|28 days post-transplant|All participants|||percentage of participants||95% Confidence Interval|Number
2803868|NCT00496340|Primary|Incidence of Greater Than or Equal to 50% Donor Chimerism|The primary endpoint was achievement of >/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).|28 days post-transplant|All participants|||percentage of participants|||Number
2803869|NCT00496262|Secondary|Classical In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||% of expected increase in fibrinogen||Full Range|Median
2803870|NCT00496262|Secondary|Incremental In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma per mg/kg dosed|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||mg/dL increase per mg/kg body weight||Full Range|Median
2803871|NCT00496262|Secondary|Volume of Distribution at Steady State (Vss)|Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||mL/kg||Standard Deviation|Mean
2803872|NCT00496262|Secondary|Mean Residence Time (MRT)|MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||hours||Standard Deviation|Mean
2803873|NCT00496262|Secondary|Clearance (Cl)|Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||mL/hour/kg||Standard Deviation|Mean
2803874|NCT00496262|Secondary|Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose|AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||hour*mg/mL||Standard Deviation|Mean
2803875|NCT00496262|Secondary|Maximum Concentration (Cmax)|Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||g/L||Standard Deviation|Mean
2803876|NCT00496262|Secondary|Terminal Elimination Half-life (t1/2)|t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|0.5 hours to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).|||hours||Standard Deviation|Mean
2803877|NCT00496262|Primary|Maximum Clot Firmness (MCF)|MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.|Pre-infusion and 1 hour post-infusion|All subjects in the intention to treat (ITT) population. The ITT population included all subjects who received any portion of any infusion of human fibrinogen concentrate. (Note: 2 subjects in the ITT population had missing MCF data; the change from baseline MCF was entered as 0.0 for these subjects.)|||millimeters||Standard Deviation|Mean
2803878|NCT00496197|Secondary|Number of Participants Who Died||Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set|||participants|||Number
2803879|NCT00496197|Secondary|Number of Participants With Non-serious and Serious Adverse Events|AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set. An event may have been reported as both a serious and non-serious adverse event, however, what is presented are distinct events; participants may be counted as having experienced > 1 event.|||participants|||Number
2803880|NCT00496197|Secondary|Number of Participants Per Specified Cause of Death|Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set is the same as the Intent-to-Treat population (ITT) and includes all participants who had taken at least 1 dose of study medication. N=number of participants who died with cause of death reported as Serious Adverse Events.|||participants|||Number
2803881|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)|Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.|Baseline up to End of Treatment (Day 5 up to Day 42)|Intent to Treat (ITT) population includes all participants who received at least 1 dose of study medication.|||days||Standard Deviation|Mean
2803882|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).|||days||Standard Error|Mean
2803883|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).|||days||Standard Error|Mean
2803884|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)|Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Time to dischargeable and time to discharge censored at Week 6 Follow-up (EOS).|||days||Standard Error|Mean
2803885|NCT00496197|Secondary|Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species|Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.|Baseline (Day 1) up to Week 6 Follow-up (EOS)|MITT; Confidence interval (CI) for the median could not be calculated by the software because no event time met the criteria for inclusion into the CI.|||days||95% Confidence Interval|Number
2803886|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803887|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803911|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
2803912|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
2803888|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803889|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803890|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803891|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 6 follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803892|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803893|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803894|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 2 follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803895|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803896|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOIV|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803897|NCT00496197|Secondary|Number of Participants With Clinical Response at EOIV|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803898|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803899|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOT|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803900|NCT00496197|Secondary|Number of Participants With Clinical Response at EOT|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803901|NCT00496197|Primary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)|Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|Modified Intent to Treat population (MITT): includes all participants who received at least 1 dose of study medication and with a positive baseline culture for a Candida spp. N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).|||participants|||Number
2803902|NCT00496080|Secondary|Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores|"Number of participants categorized as better in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. Better was defined as a change of -11 or less from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 18 participants.)|||participants|||Number
2803903|NCT00496080|Secondary|Decrease in Fibroid Bulk|"Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.~Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200."|From baseline to 12-months|ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)|||participants|||Number
2803904|NCT00496080|Secondary|Procedural Satisfaction|"Number of participants with responses of either satisfied or very satisfied on a qualitative survey that ranged from very dissatisfied (worst) to very satisfied (best)"|12 months|ITT (No data for 19 participants)|||participants|||Number
2803905|NCT00496080|Secondary|Maintenance of Menses|Number of participants with continuation of menstrual cycles without interruption for three consecutive months|12 months|ITT (No data for 30 participants)|||participants|||Number
2803906|NCT00496080|Secondary|Mean Improvement in Health Related Quality of Life (HRQOL) Scores|"Participants categorized as better in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. Better was defined as a change of +12 or more from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 20 participants)|||participants|||Number
2803907|NCT00496080|Primary|Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score|Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.|From baseline to 12 months|ITT (No data for 18 participants)|||participants|||Number
2803908|NCT00496080|Primary|No Surgical Re-intervention|Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.|Study completion|ITT (Data missing for 5 participants)|||participants|||Number
2803909|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
2803910|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
2804382|NCT00492284|Secondary|Mean Change From Baseline in Study Eye Best-Corrected VA Score|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 24||||Letters read on ETDRS chart||95% Confidence Interval|Mean
2803913|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
2803914|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
2803915|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
2803916|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
2803917|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
2803918|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
2803919|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Titer||95% Confidence Interval|Geometric Mean
2803920|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Titer||95% Confidence Interval|Geometric Mean
2803921|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
2803922|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
2803923|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
2803924|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
2803925|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results|||Percentage of Participants|||Number
2803926|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
2803927|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
2803928|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
2803929|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
2803930|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
2803931|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results.|||Percentage of Participants|||Number
2803932|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data|||Percentage of Participants|||Number
2803933|NCT00496015|Secondary|Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.|Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.|1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803934|NCT00496015|Secondary|Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs|Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.|1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803935|NCT00496015|Secondary|Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae|Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.|Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Swabs|||Number
2803936|NCT00496015|Secondary|Number of Nasopharyngeal Swabs With H. Influenzae|Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.|Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Swabs|||Number
2803937|NCT00496015|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)|Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.|Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Swabs|||Number
2803938|NCT00496015|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)|Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.|Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Swabs|||Number
2803939|NCT00496015|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)|Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.|Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Swabs|||Number
2803940|NCT00496015|Secondary|Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers|The seroprotection cut-off for the assay was ≥ 8.|12 month post-vaccination (M12)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2803941|NCT00496015|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|The seroprotection cut-off for the assay was ≥ 10 mIU/mL.|12 month post-vaccination (M12)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2803942|NCT00496015|Secondary|Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers|The seroprotection cut-off for the assay was ≥ 8.|1 month post-vaccination (M1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2803943|NCT00496015|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations|The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.|1 month post-vaccination (M1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2803944|NCT00496015|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|The seroprotection cut-off for the assay was ≥ 10 mIU/mL.|1 month post-vaccination (M1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2803966|NCT00495820|Secondary|Clinical Global Impression|The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness.|At 12 weeks||||units on a scale||Standard Deviation|Mean
2803945|NCT00496015|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).|1 month post-vaccination (M1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Number
2803946|NCT00496015|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).|The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).|1 month post-vaccination (M1)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2803947|NCT00496015|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group|The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.|Prior to vaccination (Pre)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2803948|NCT00496015|Secondary|Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group|The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).|Prior to vaccination (Pre)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2803949|NCT00496015|Secondary|Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations|Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).|Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2803950|NCT00496015|Secondary|Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values|Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).|Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803951|NCT00496015|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group|Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).|Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2803952|NCT00496015|Secondary|Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values|"The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY).~Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group)."|Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803953|NCT00496015|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.|Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination|The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||97.5% Confidence Interval|Geometric Mean
2803954|NCT00496015|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)|Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).|Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination|The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||μg/mL||97.5% Confidence Interval|Geometric Mean
2803967|NCT00495820|Secondary|Mini-mental State Examination (MMSE) at 12 Weeks|Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition|At 12 weeks||||units on a scale||Standard Deviation|Mean
2803955|NCT00496015|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).|Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination|The analyses were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2803956|NCT00496015|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.|Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination|The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2803957|NCT00496015|Secondary|Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.|"Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).~Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).~Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL)."|Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination|The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2803958|NCT00496015|Secondary|Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off|"Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).~The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL)."|Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination|The analysis were performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2803959|NCT00496015|Secondary|Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.|Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.|Up to 6 months after vaccination with Mencevax™|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
2803960|NCT00496015|Secondary|Number of Subjects Reported With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Month 0-Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803961|NCT00496015|Secondary|Number of Subjects Reported With Unsolicited Adverse Events (AEs)|"The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group.~An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|Within 31 days (Days 0-30) after primary vaccine dose.|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803962|NCT00496015|Secondary|Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature >40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.|During the 4-day (Day 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803963|NCT00496015|Secondary|Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters (mm) from injection site.|During the 4-day (Days 0-3) post-primary vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803964|NCT00496015|Secondary|Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off|The cut-off value for core fever (rectal temperature) was 39.0ºC.|Within 4 days (Day 0-3) after primary vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803965|NCT00496015|Primary|Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off|The cut-off for core fever was 38.0 degrees Celsius (ºC).|Within 4 days (Day 0-3) after primary vaccine dose.|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2803968|NCT00495820|Primary|Apathy Evaluation Scale Score at 12 Weeks|The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.|At 12 weeks||||units on a scale||Standard Deviation|Mean
2803969|NCT00495794|Secondary|LDL Control||12 months after invention period|Includes only participants with a LDL in the 12 months after the intervention period.|||mg/dl||Standard Deviation|Mean
2803970|NCT00495794|Secondary|A1c Control||12 months after intervention period|Includes only participants with an A1c in the 12 months after the intervention period.|||percentage of total hemoglobin||Standard Deviation|Mean
2803971|NCT00495794|Primary|Change in Systolic Blood Pressure||6 months prior to 6 months after the intervention period|intention to treat analysis|||mmHg||95% Confidence Interval|Mean
2803972|NCT00495755|Secondary|The Effect of Alemtuzumab Therapy on Parameters of Cellular and Humoral Immunity in the Late Post Transplant Period. This Information is Exploratory in Nature Only Due to the Heterogeneity of the Anticipated Patient Population.||12|||||||
2803973|NCT00495755|Secondary|The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD).|Efficacy measured as complete response (CR), partial response (PR), stable disease (SD) and cGVHD progression (PD). CR is defined as absence of all measurable or symptomatic cGVHD, PR is defined as a remission in some but not all involved organs. SD is defined as no measurable change in GVHD and PD is defined as progression in at least one involved organ.|12 weeks||||participants|||Number
2803974|NCT00495755|Primary|The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids|MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity|12 weeks||||mg|||Number
2803975|NCT00495716|Secondary|The Acceptability and Adherence to Suppressive Antiviral Therapy for HSV-2 Prevention Among Single, Sexually Active Men and Women.||1 year|||||||
2803976|NCT00495716|Primary|The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.||1 year|Study terminated; investigator relocated and study funding ended. Results cannot be analyzed because data were not collected.||||||
2803977|NCT00495677|Other Pre-specified|Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping|CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.|Pre-dose on Day 1|Results for this outcome were not analyzed because there were no unusual patterns of response or an unexplained excess of adverse events that warranted genotyping.||||||
2803978|NCT00495677|Other Pre-specified|Number of Participants With Viral Tropism and Resistance|Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.|Screening, pre-dose on Day 1; Day 11, 25|Results for this outcome was not reported because data was collected in individual participant listings, but not summarized for analyses.||||||
2803979|NCT00495677|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).|0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2803980|NCT00495677|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.|||hours||Full Range|Median
2803981|NCT00495677|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2803982|NCT00495677|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.|Day 1 up to Day 25|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.|||participants|||Number
2803983|NCT00495677|Primary|Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11|Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.|Baseline, Day 11|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.|||log10 copies/mL||Standard Deviation|Mean
2803984|NCT00495625|Primary|Number of Participants With Progressive Disease (PD) at Interim Analysis|Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.|||participants|||Number
2803985|NCT00495625|Primary|Number of Participants With Stable Disease (SD) at Interim Analysis|Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.|||participants|||Number
2803986|NCT00495625|Secondary|Number of Participants With Serious Adverse Events (SAEs)|The toxicity of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|All participants|||participants|||Number
2803987|NCT00495625|Secondary|Number of Participants With Overall Survival (OS)|Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|Participants who had not expired on their off study date.|||participants|||Number
2803988|NCT00495625|Secondary|Participant Time to Tumor Progression (TTP)|Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.|On Treatment to Off Study - average of 7 months per participant|Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.|||months||Full Range|Mean
2803989|NCT00495625|Primary|Number of Participants With Partial Response (PR) at Interim Analysis|Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.|||participants|||Number
2803990|NCT00495612|Secondary|Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16|The challenge was stopped if a patient stated that they were extremely uncomfortable and would like to leave the room, the FEV1 has decreased by 50% from the baseline value, or after 60 minutes of exposure. The duration of allergen exposure was the time from when the patient entered the exposure room until the challenge stopped, with a maximum of 60 minutes. A longer duration indicates greater tolerance of the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Minutes||95% Confidence Interval|Median
2803991|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The NOSS was defined as the total of 4 sub-scores: Nasal congestion, rhinorrhea, nasal pruritus, ocular pruritus, and ocular tearing. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum NOSS was 15 points. A lower score indicates a reduced response to the allergen exposure and fewer nasal-ocular symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Units on a scale*hours||Standard Deviation|Mean
2803992|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The chest symptom score was defined as the total of 4 sub-scores: Chest tightness, wheezing, shortness of breath, and cough. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum chest symptom score was 12 points. A lower score indicates a reduced response to the allergen exposure and fewer respiratory symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Units on a scale*hours||Standard Deviation|Mean
2803993|NCT00495612|Secondary|Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Percent change||Standard Deviation|Mean
2803994|NCT00495612|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Percent change||Standard Deviation|Mean
2803995|NCT00495612|Primary|Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.|||Percent change from pre-challenge*hours||Standard Deviation|Mean
2803996|NCT00495586|Secondary|Number of Days Till the Next Exacerbation|For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days.|One year|Patients with clinical success at the end of therapy visit|||Days||Inter-Quartile Range|Median
2803997|NCT00495586|Primary|Number of Patients Who Were Cured|Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability|Day 9-11|Clinical cure at end of therapy visit at day 9-11 in the ITT population|||Participants|||Number
2803998|NCT00495521|Secondary|Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion||4 weeks|||||||
2803999|NCT00495521|Secondary|Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization||2 weeks and 4 weeks|||||||
2804000|NCT00495521|Secondary|Time to Normalization of All Other Components in the Diary||up to 4 weeks|||||||
2804001|NCT00495521|Secondary|Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance||up to 4 weeks|||||||
2804002|NCT00495521|Secondary|Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary||4 weeks|||||||
2804003|NCT00495521|Secondary|Change in IMPACT-III From Baseline to 4 Weeks||4 weeks|||||||
2804004|NCT00495521|Secondary|Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks||4 weeks|||||||
2804005|NCT00495521|Secondary|Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks||4 weeks|||||||
2804006|NCT00495521|Secondary|Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary||up to 4 weeks|||||||
2804007|NCT00495521|Secondary|Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks||4 weeks|||||||
2804008|NCT00495521|Secondary|Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks||4 weeks|||||||
2804009|NCT00495521|Secondary|Rate of Remission|Rate of remission was defined by a decrease in modified Crohn's Disease Activity Index (mCDAI) > 100 points and total mCDAI < 150 by 4 weeks|4 weeks||||Participants|||Count of Participants
2804010|NCT00495521|Primary|Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline|Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline|4 weeks||||participants|||Number
2804011|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase at Least 10)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.|||teeth|Participants||Number
2804012|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units or an increase in DIAGNOdent reading from below 20 to above 30 units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.|||teeth|Participants||Number
2804013|NCT00495495|Secondary|Progression of Radiographic Scores at 12 Months|"Clinically significant changes for Bitewing x-rays indicating caries progression would be changes in x-ray criterion for lesion presence from no to yes or for lesion depth to a D1 or higher. The occlusal surface of study teeth will be evaluated using the following scale:~Lesion presence: yes /no~Lesion depth:~E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure"|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.|||teeth|Participants||Number
2804014|NCT00495495|Secondary|Change in Caries Lesion Activity|"Change in caries lesion activity at One Year. All teeth were considered Active at Baseline~Caries Lesion Activity score:~= Inactive - surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.~= Active lesion - surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface."|Baseline and one year|"Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.~Clinically significant changes for Activity Scores were indicated by a change in caries activity status from active to inactive. It should be noted that all teeth were considered active at baseline."|||teeth|Participants||Number
2804015|NCT00495495|Primary|ICDAS Severity Value|"Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows:~0 = Sound tooth surface.~= First visual change in enamel.~= Distinct visual change in enamel.~= Localized enamel breakdown due to caries with no visible dentin.~= Underlying dark shadow from dentin, with or without localized enamel breakdown.~= Distinct cavity with visible dentin.~= Extensive distinct cavity with visible dentin."|Baseline and One Year|The study utilized a split-mouth design. The results posted are for the Per Protocol dataset. Subjects who completed all four treatment/examination visits as well as final examination visit without major protocol violations were included in this dataset.|||teeth|Participants||Number
2813857|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Glucose.|Blood chemistry - fasting glycemia (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population|||mmol/L||Standard Deviation|Mean
2804016|NCT00495469|Secondary|Number of Participants With Abnormal Hematology Value of PCI at Any Time on Therapy|Hematology parameters: Hemoglobin, Hematocrit, Platelet count and White blood cells were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).|Up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2804017|NCT00495469|Secondary|Number of Participants With Abnormal Chemistry Value of PCI at Any Time on Therapy|Chemistry parameters: Albumin, Alkaline phosphatase, Alanine animotransferase, Aspartate aminotransferase, Total billirubin, Calcium, Carbon dioxide/Bicarbonate, Glucose, Potassium, Sodium, Phosphorus and Total protein were assessed for abnormal PCI values. Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. Samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up).|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2804018|NCT00495469|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline|Full 12-lead ECGs were recorded at Randomization (Week 0), Week 4, and Week 12 or early withdrawal. If the QTc was >500 milliseconds on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 milliseconds, the participant was withdrawn from the study.|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2804019|NCT00495469|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) at Any Time on Therapy|Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured pre-dose in duplicate, after the participant has been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements.|Up to Week 12|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2804020|NCT00495469|Secondary|Number of Participants With On-therapy Hypoglycemia|Participants were provided with a Daily Glucose Monitoring Log to record glucose meter readings and to record symptoms of hypoglycemia. A separate electronic case report form (eCRF) page was provided to capture events of hypoglycemia.|Up to Week 12|Safety Population.|||Participants|||Count of Participants
2804021|NCT00495469|Secondary|Number of Participants With Any On-therapy Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Week 12|Safety Population consisted of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2804022|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Body Weight|Body weight measurement was taken at Baseline, Week 2, Week 4, Week 8, Week 12 and at Week 14 (follow up). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF.|||kilograms||Standard Error|Least Squares Mean
2804023|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Total Cholesterol/HDL-c Ratio|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
2804024|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in LDL-c/HDL-c Ratio|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
2804025|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in High Density Lipoprotein Cholesterol (HDL-c)|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2804026|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Low Density Lipoprotein Cholesterol (LDL-c)|Blood samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2804038|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8||||participants|||Number
2804027|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Total Cholesterol|Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2804028|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Triglycerides|Samples were collected at Baseline and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population with LOCF. Only those participants with data available at the indicated time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2804029|NCT00495469|Secondary|Number of Participants Who Were Fasting Plasma Glucose (FPG) Responders at Week 12|Differences between treatment groups in the proportion of participants who achieved FPG targets of <7.0 millimoles per liter (mmol/L) (126 milligrams per deciliter [mg/dL]) and <7.8 mmol/L (140 mg/dL) at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline FPG. The proportion of participants who achieved the target of <5.5 mmol/L (100 mg/dL) at Week 12 within each treatment group were summarized only. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in FPG (1.7 mmol/L [>=30 mg/dL]) at Week 12 were assessed in the same manner.|Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2804030|NCT00495469|Secondary|Number of Participants Who Were HbA1c Responders at Week 12|Differences between treatment groups in the proportion of participants who achieved HbA1c targets of <=6.5% and <7% at Week 12 in the ITT population with LOCF were assessed based on a logistic regression model with terms included for treatment and Baseline HbA1c. Differences between treatment groups in the proportion of participants who achieved a clinically meaningful decreases from Baseline in HbA1c (>=0.7%) at Week 12 were assessed in the same manner.|Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2804031|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Fructosamine (Corrected)|The blood samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||micromoles per liter (µmol/L)||Standard Error|Least Squares Mean
2804032|NCT00495469|Secondary|Mean Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)|The samples were collected at Baseline, Week 2, Week 4, Week 8, Week 12 and Week 14 (follow up). Participants were asked to be on fast for at least 8 hours prior to each study visits and collection of lab samples. Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF. Adjusted mean is presented as LS mean.|Baseline (Week 0) and at Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2804033|NCT00495469|Secondary|Mean Change From Baseline in HbA1c at Weeks 4 and 8|The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 4 and 8 minus Baseline value. The primary analysis was performed on the ITT Population with LOCF.|Baseline (Week 0) and at Week 4 nad 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
2804034|NCT00495469|Primary|Mean Change From Baseline in Hemoglobin A1c (Glycosylated Hemoglobin) (HbA1c) at Week 12|The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation carried forward (LOCF). Adjusted mean is presented as least square (LS) mean.|Baseline (Week 0) and at Week 12|ITT Population consisted of all randomized participants who received at least one dose of study medication, had a Baseline assessment, and had at least one corresponding on-therapy efficacy assessment. Only those participants with data available at the indicated time points were analyzed.|||Percentage||Standard Error|Least Squares Mean
2804035|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up||||participants|||Number
2804036|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment||||participants|||Number
2804037|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 16||||participants|||Number
2804042|NCT00495391|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment||||participants|||Number
2804043|NCT00495222|Primary|Knotting Elements Placed|completion of plication (1-3 knotting elements placed per procedure)|intra-operative|Intent to Treat|||elements|||Number
2804044|NCT00495170|Primary|Overall Survival and Progression Free Survival|"The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care.~Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up.~Progression-free survival (PFS) was defined from enrollment to any treatment failure or death. PFS will be evaluated by series CT of chest with contrast for every follow up except 6 weeks after the concurrent chemo radiotherapy for two years.~Multivariate Cox proportional hazards modeling was used to examine predictors of OS when adjusting for each of the collected potential confounding variables."|The Overall survival (OS): From date of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): From date of registration to the date of first documented progression or death up to 5 years.|Kaplan-Meier analysis of overall survival (OS), progression-free survival (PFS), actuarial distant metastasis, and local regional recurrence. Patterns of treatment failure were categorized as local/regional or distant. Acute and late toxic effects were prospectively assigned using Common Terminology Criteria for Adverse Events, v3.0.|||percentage of participants|||Number
2804045|NCT00495157|Secondary|Adverse Events||Measured during the 36-week treatment period|||||||
2804046|NCT00495157|Secondary|Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids||Measured during the 36-week treatment period|||||||
2804047|NCT00495157|Secondary|Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25||Measured during the 36-week treatment period|||||||
2804048|NCT00495157|Secondary|Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)||Measured during the 36-week treatment period|||||||
2804049|NCT00495157|Secondary|Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)||Measured during the 36-week treatment period|||||||
2804050|NCT00495157|Secondary|Number of Asthma Exacerbations||Measured during the 36-week treatment period|||||||
2804051|NCT00495157|Secondary|Time to First Asthma Exacerbation||Measured during the 36-week treatment period|||||||
2804052|NCT00495157|Secondary|Number of Episodes of Treatment Failure||Measured during the 36-week treatment period|||||||
2804053|NCT00495157|Primary|Time to Treatment Failure (Measured in Days)||Measured during the 36-week treatment period|All participants were followed for time to treatment failure or right censoring (measured in days).|||days||Standard Error|Mean
2804054|NCT00495131|Secondary|Histologic Response|Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy|18 months|Data included for analysis only for patients with paired liver biopsies.|||Participants|||Number
2804055|NCT00495131|Primary|Sustained Biochemical Response|Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization|18 months|Patients with end of follow-up alanine aminotransferase (ALT) levels|||Participants|||Number
2804056|NCT00495131|Primary|Sustained Virologic Response|Undetectable HCV RNA 6 months off therapy|18 months|Intention-to-treat (ITT) analysis by last observation carried forward|||participants|||Number
2804057|NCT00495131|Secondary|Treatment-related Withdrawal Rate|Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events|18 months||||Participants|||Number
2804058|NCT00495079|Primary|Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation|Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC>=1X10^9/L or Platelet count>=100x10^9/L, absence of blasts in blood and morrow (<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count <100x10^9/L or ANC<1x10^9/L.|Response assessment at the end of each 28 days course|The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.|||participants|||Number
2804059|NCT00495079|Secondary|Overall Survival|Time, in days, from informed consent date until the date of death or date of last contact|unlimited|Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)|||days||95% Confidence Interval|Median
2804060|NCT00495079|Secondary|Duration of CR + CRi|Duration of response for those subjects who achieved CR or CRi|CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapse|Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)|||days||95% Confidence Interval|Median
2804061|NCT00495079|Primary|Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)|CR is defined as no evidence of ALL: ANC>or=1x10^9/L or platelet count>100x10^9/L, absence of leukemia blast cells in blood and marrow (<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count< 100x10^9/L or ANC< 1x10^9/L. Partial remission(PR):CR with>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.|Response assessment performed at the end of each 28 day course.|Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon’s 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.|||participants|||Number
2804062|NCT00495040|Primary|Overall Survival and Progression Free Survival|"Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS).~Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis."|The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.|Kaplan–Meier curves used for overall survival, progression-free survival, local recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival. Differences between pairs of Kaplan–Meier curves were using the log-rank test. The Fisher’s exact test was used to compare local, regional, and distant recurrence rates.|||percentage of participants (%)|||Number
2804063|NCT00494975|Secondary|Detailed Questionnaire at Baseline and After 18 Sessions||at baseline and after 18 sessions|||||||
2804064|NCT00494975|Primary|Visual Analogue Scale (VAS) Score for Pruritus|"a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus.~0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions"|VAS score at baseline and after 6 -week phototherapy||||Units on a scale||Standard Deviation|Mean
2804065|NCT00494871|Secondary|Event Rate Adjudicated Non-major Clinically Relevant Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).|||Events per 100 patient-years|||Number
2804066|NCT00494871|Secondary|Event Rate of Adjudicated Major Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).|||Events per 100 patient-years|||Number
2804067|NCT00494871|Secondary|Event Rate of All-cause Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804068|NCT00494871|Secondary|Event Rate of Stroke With Serious Residual Disability|All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant's modified Rankin score was between 3 and 5, inclusive.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804069|NCT00494871|Secondary|Event Rate of Vascular Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804070|NCT00494871|Secondary|Event Rate of Myocardial Infarction|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804071|NCT00494871|Secondary|Event Rate of Non-CNS Systemic Embolism|"All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804072|NCT00494871|Secondary|Event Rate of Stroke|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804073|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804074|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804075|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism|"This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).|||Events per 100 patient-years|||Number
2804076|NCT00494871|Primary|Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding|Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).|||Events per 100 patient-years|||Number
2804077|NCT00494806|Primary|Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.|Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).|Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).|Intention to treat (ITT) method was used.|||Days||Standard Deviation|Mean
2804078|NCT00494780|Secondary|Vss at the Sixth Infusion (Week 15, Visit 22)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2804079|NCT00494780|Secondary|CL After the Sixth Infusion (Week 15, Visit 22)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2804080|NCT00494780|Secondary|Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)|Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
2804081|NCT00494780|Secondary|AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milligrams * hours/liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
2804082|NCT00494780|Secondary|Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]).|Week 15 (Visit 22)|FAS. Data were provided for the number of participants who had a value. Participants withdrawn during the study were not analyzed.|||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2804083|NCT00494780|Secondary|Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy|This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.|Maximum of 6 years follow-up|FAS||||||
2804084|NCT00494780|Primary|Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)|Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions).|Maximum of 23 months after the start of treatment|FAS|||participants|||Number
2804085|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22|The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Screening, Week -2) and Visit 22 (Week 15)|FAS. Only those participants who remained in the study at Visit 22 were analyzed.|||Percent change in serum complement CH50||Full Range|Median
2804086|NCT00494780|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.|Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)|FAS. Participants dropped out of the study as the study progressed.|||participants|||Number
2804087|NCT00494780|Secondary|Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.|Up to 22 months after study start|FAS|||participants|||Number
2804088|NCT00494780|Secondary|Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Only those participants who provided samples at Visit 33 were analyzed.|||Percent change in cell counts||Full Range|Median
2804089|NCT00494780|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.|Followed up to 5 years|FAS. Only those participants with a response were analyzed.|||months||95% Confidence Interval|Median
2804090|NCT00494780|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression or death.|Followed up to 5 years|FAS|||months||95% Confidence Interval|Median
2804091|NCT00494780|Secondary|Time to New Anti-follicular Lymphoma (FL) Therapy|Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.|Followed up to 5 years|FAS|||months||95% Confidence Interval|Median
2804092|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Participants were withdrawn from the study between Visits 1 and 33.|||Percent change in tumor size||Full Range|Median
2804093|NCT00494780|Secondary|Number of Participants With Complete Remission (CR) at Visit 26|Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.|Maximum of 23 months after the start of treatment|FAS|||participants|||Number
2804094|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and then discontinued wearing prism glasses.|||logits||Standard Deviation|Mean
2804095|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and continued to wear prism glasses in the long term.|||logits||Standard Deviation|Mean
2804122|NCT00494494|Primary|Pre-operative Best Corrected Visual Acuity (BCVA)|Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline|The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).|||letters||Standard Deviation|Mean
2804096|NCT00494676|Secondary|Mobility Change Score (All Participants Who Completed Crossover)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis|||logits||Standard Deviation|Mean
2804097|NCT00494676|Primary|"Overall Proportion Saying Yes to Real Prism Glasses"|"At the end of each crossover period, participants were asked a yes/no question: If the study were to end today, would you want to continue with these prism glasses (i.e. the prism glasses worn in that period)? The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants saying yes to real prism glasses and the proportion saying yes to sham prism glasses."|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis|||participants|||Number
2804098|NCT00494585|Primary|Number of Participants With Objective Response|Objective response = Complete Response, absence sign/symptoms of disease (without use of growth factors, hydroxyurea, anagrelide, or transfusions for > 1 month); Partial Response, absence of progressive disease (PD), and improvement in 2+ parameters (if abnormal): Absolute neutrophil count (ANC), hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts; Clinical Improvement, absence of PD, and improvement in 1 parameter: ANC, hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts). [International Working Group on Myelofibrosis Research and Treatment]|Response assessed after each 3 cycles (cycle = 30 days)|Intention to treat.|||Participants|||Number
2804099|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
2804100|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in SF-36 Mental Health Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The mental health component summary score is calculated from the four scales of VT, SF, MH, and RE. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
2804101|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP, BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
2804102|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in SF-36 Physical Component Summary Score|The Medical Outcomes Study Short Form (SF-36) questionnaire is a widely used profile measure of generic health-related quality of life. The 36 questions are allocated to eight scales: physical function (PF), physical role (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social function (SF), mental health (MH), and emotional role (RE). The physical component summary score is calculated from the four scales of PF, RP,BP, and GH. Scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. Higher scores are associated with better quality of life.|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||T-score||Standard Deviation|Mean
2804103|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Lean Body Mass|Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).|Baseline and 9 weeks|Participants who had lean body mass data available at baseline and week 9.|||kg||Standard Deviation|Mean
2804104|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Lean Body Mass|Lean body mass was measured by dual-energy X-ray absorptiometry (DEXA).|Baseline and 9 weeks|Participants who had lean body mass data available at baseline and week 9.|||kg||Standard Deviation|Mean
2804105|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||average percent of predicted normal||Standard Deviation|Mean
2804164|NCT00494013|Secondary|Number of Injections of Basal Insulin Analog at Endpoint||24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||participants|||Number
2804106|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing Percent of Predicted Normal|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the percent of predicted normal given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average percent of predicted normal score. A higher number indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||average percent of predicted normal||Standard Deviation|Mean
2804107|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||Z-score||Standard Deviation|Mean
2804108|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Maximum Voluntary Isometric Contraction Testing (MVICT) Scores|"The strength of each of 10 muscles was measured using quantitative myometry and expressed as the number of standard deviations from normal (Z-score) given the participant's age, gender, and height. The scores were averaged across muscles to form a composite MVICT score: average standardized MVICT score. A positive Z-score indicates a better outcome.~The following muscles were tested: elbow extensor (left/right), elbow flexor (left/right), knee extensor (left/right), knee flexor (left/right), and hand grip (left/right)."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||Z-score||Standard Deviation|Mean
2804109|NCT00494507|Secondary|HOP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score|"The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.~The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||units on a scale||Standard Deviation|Mean
2804110|NCT00494507|Secondary|HYP Change From Baseline to Week 9 in Average Manual Muscle Testing (MMT) Score|"The strength of each of 26 individual muscles was graded using a modified 13-point Medical Research Council scale ranging from 0-5. Recorded grades were converted to numerical values as follows prior to averaging across muscles to form a composite score: 0 = 0; 1 = 1; 2- = 1.67; 2 = 2; 2+ = 2.33; 3- = 2.67; 3 = 3; 3+ = 3.33; 4- = 3.67; 4 = 4; 4+ = 4.33; 5- = 4.67; 5 = 5. A higher score represents a better outcome, i.e. 5 = normal strength.~The following muscles were tested: shoulder abductor (left/right), elbow extensor (left/right), elbow flexor (left/right), wrist extensor (left/right), wrist flexor (left/right), hip flexor (left/right), hip extensor (left/right), hip abductor (left/right), knee extensor (left/right), knee flexor (left/right), ankle dorsiflexor (left/right), ankle plantar flexor (left/right), neck extensor, neck flexor."|Baseline and 9 weeks|Participants with evaluable data at both timepoints|||units on a scale||Standard Deviation|Mean
2804111|NCT00494507|Secondary|HOP Endpoint of Acute Worsening|Increase in attack frequency or severity in HOP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks||||participants|||Number
2804112|NCT00494507|Secondary|HYP Endpoint of Acute Worsening|Increase in attack frequency or severity in HYP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks||||participants|||Number
2804113|NCT00494507|Secondary|HOP Attack Duration|HOP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks||||hours per week||Inter-Quartile Range|Median
2804114|NCT00494507|Secondary|HYP Attack Duration|HYP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks||||hours per week||Inter-Quartile Range|Median
2804115|NCT00494507|Secondary|HOP Severity-weighted Attack Rate|HOP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks||||severity-weighted attacks per week||Inter-Quartile Range|Median
2804116|NCT00494507|Secondary|HYP Severity-weighted Attack Rate|HYP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks||||severity-weighted attacks per week||Inter-Quartile Range|Median
2804117|NCT00494507|Primary|HOP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HOP participants.|8 weeks||||attacks per week||Inter-Quartile Range|Median
2804118|NCT00494507|Primary|HYP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HYP participants.|8 weeks||||attacks per week||Inter-Quartile Range|Median
2804119|NCT00494494|Primary|Post-operative Best Corrected Visual Acuity (BCVA)|The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline and 8 weeks||||letters||95% Confidence Interval|Mean
2804123|NCT00494494|Primary|Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)|The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)|baseline and 8 weeks|Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.|||microns||95% Confidence Interval|Mean
2804124|NCT00494481|Primary|Number of Patients With a Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off||||Participants|||Number
2804125|NCT00494442|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm|||Days||95% Confidence Interval|Median
2804126|NCT00494442|Secondary|Best Percentage Change in Tumour Size|The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm|||Percent change||Full Range|Median
2804127|NCT00494442|Secondary|Duration of Response|Duration of response to olaparib|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm|||Days||Full Range|Median
2804128|NCT00494442|Secondary|Clinical Benefit (CB)|Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)|End of study|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm)|||Percentage of participants||95% Confidence Interval|Number
2804129|NCT00494442|Primary|Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.|PP Analysis Set (includes all enrolled patients who complete the trial schedule and medication regime without any major deviations to the protocol - this is the main analysis population, with ITT used to confirm)|||Participants|||Number
2804130|NCT00494299|Post-Hoc|Number of Death Cases Due to Any Cause||From randomization of the first subject until death due to any cause assessed up to 55 months.|"Intention to treat (ITT) population. Overall Survival is shown in Secondary Outcome Measure: Overall Survival."|||Participants|||Number
2804131|NCT00494299|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.|From randomization of the first subject until 39 months later.|"Median overall survival (OS) and 95% Confidence interval (CI) were not estimable in Placebo Group and Upper Limit of 95% CI was not in Sorafenib Group because of more than half (188 for Placebo,186 for Sorafenib) of the individual study populations censored. Number of death is shown in Post-Hoc Outcome Measure."||||||
2804132|NCT00494299|Primary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.|Intention to treat (ITT) population.|||days||95% Confidence Interval|Median
2804133|NCT00494234|Secondary|Change From Baseline in ECOG Performance Status: Improvement Rate|The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.|At cycle 7 day 1 (ie, after completing 6 cycles of treatment)||||Participants with an improvement in ECOG|||Number
2804134|NCT00494234|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.|End of study||||Days||95% Confidence Interval|Median
2804135|NCT00494234|Secondary|Best Percent Change in Tumour Size|The tumour size is defined as the sum of the longest diameters as measured among all target lesions.|End of study||||Percent change in tumour size||95% Confidence Interval|Mean
2804136|NCT00494234|Secondary|The Clinical Benefit Rate (CBR)|The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for ≥8 weeks +/- 1 week visit window.|End of study|Per protocol|||Percentage of Participants||95% Confidence Interval|Number
2804137|NCT00494234|Secondary|Duration of Response to Olaparib||Time from response (CR or PR) to progression per RECIST criteria|Per protocol|||Days||Full Range|Median
2804165|NCT00494013|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||Units of Insulin/kilograms (U/kg)||Standard Deviation|Mean
2804138|NCT00494234|Primary|Confirmed Objective Tumour Response (According to RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years.||||Participants|||Number
2804139|NCT00494221|Secondary|Overall Survival|Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)||||Months||Full Range|Median
2804140|NCT00494221|Secondary|Duration of Response|Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)||||Months||Standard Deviation|Mean
2804141|NCT00494221|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)||||Percentage||Standard Deviation|Mean
2804142|NCT00494221|Secondary|Objective Tumour Response Rate|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)||||Participants|||Number
2804143|NCT00494221|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)||||Months||Full Range|Median
2804144|NCT00494143|Secondary|Peak Intact Knee Loading|The biomechanical measure of the first peak of the knee external adduction moment|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection||||newton meters per kilogram||Standard Deviation|Mean
2804145|NCT00494143|Secondary|Prosthetic Foot Push Off Peak Power|The biomechanical measurement of the power generated by the prosthetic foot during the push off component of stance phase. The peak power output during the push off component of stance phase was calculated in Joules. It was subsequently standardized for body weight in Kgs. The final units were therefore Joules/Kg.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection||||joules per kilogram||Standard Deviation|Mean
2804146|NCT00494143|Primary|Metabolic Oxygen Consumption During Ambulation|VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection||||Watts per kilogram||Standard Deviation|Mean
2804147|NCT00494091|Other Pre-specified|Volume of Distribution at Steady State (Vss) of Temsirolimus|"Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||Liter||Standard Deviation|Mean
2804148|NCT00494091|Other Pre-specified|Clearance (CLss) of Temsirolimus|"Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||Liter per hour (L/h)||Standard Deviation|Mean
2804149|NCT00494091|Other Pre-specified|Area Under the Concentration-Time Curve (AUC)|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng*h/mL||Standard Deviation|Mean
2804166|NCT00494013|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||Units of insulin||Standard Deviation|Mean
2804150|NCT00494091|Other Pre-specified|Plasma Decay Half-Life (t1/2)|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2804151|NCT00494091|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Full Range|Median
2804152|NCT00494091|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2804153|NCT00494091|Secondary|Overall Survival (OS)|Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline Until Death (Up to 4 years)|ITT population included all participants who were enrolled in this study.|||months||95% Confidence Interval|Median
2804154|NCT00494091|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.|||months||95% Confidence Interval|Median
2804155|NCT00494091|Secondary|Duration of Response|Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.|Baseline Up to 4 years|Intent-to-treat ITT population included all participants who were enrolled in this study. Here N (number of participants analyzed) signifies participants with objective disease response.|||months||95% Confidence Interval|Median
2804156|NCT00494091|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
2804157|NCT00494091|Secondary|Progression-free Survival (PFS)|Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.|||months||95% Confidence Interval|Median
2804158|NCT00494091|Primary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Baseline Up to 4 years|Intent-to-treat (ITT) population included all participants who were enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
2804159|NCT00494026|Secondary|Pharmacology Toxicity|Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.|every 21-day cycle for 4 cycles|All enrolled patients who received radiotherapy.|||participants|||Number
2804160|NCT00494026|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|Trial was terminated early. Results were not analyzed.|||months||95% Confidence Interval|Median
2804161|NCT00494026|Secondary|Overall Survival|Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause, 1 year|Trial was terminated early. Results were not analyzed.|||months||95% Confidence Interval|Median
2804162|NCT00494026|Secondary|Progression-free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline to measured progressive disease|Trial was terminated early. Results were not analyzed.|||months||95% Confidence Interval|Median
2804163|NCT00494026|Primary|Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured response after chemotherapy and radiation|Trial was stopped too early to assess the primary endpoint.|||proportion of responders|||Number
2804167|NCT00494013|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||kilograms (kg)||Standard Deviation|Mean
2804168|NCT00494013|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||hypoglycemic events per 30 days||Standard Deviation|Mean
2804169|NCT00494013|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||hypoglycemic events per 1 year||Standard Deviation|Mean
2804170|NCT00494013|Secondary|Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||participants|||Number
2804171|NCT00494013|Secondary|7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint|Actual daily mean blood glucose levels at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2804172|NCT00494013|Secondary|Glycemic Variability|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2804173|NCT00494013|Secondary|Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||percentage of participants|||Number
2804174|NCT00494013|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.|||percent hemoglobin||Standard Error|Least Squares Mean
2804175|NCT00494013|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.|||percent of HbA1c||Standard Error|Least Squares Mean
2804176|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours|Baseline and 72 hours later|"Intent to Treat.~Participants with urine sample at both visits."|||(ng/mg Cr.)||Standard Error|Log Mean
2804177|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours|Baseline and 24 hours|"Intent to Treat.~Participants with urine sample at both visits."|||(ng/mg Cr.)||Standard Error|Log Mean
2804178|NCT00493974|Secondary|Health-related Quality of Life|"St. George's Respiratory Questionnaire - Total Score~The SGRQ was asked with respect to the last one month as validated for acute exacerbations of COPD by Doll et al.~Scale from 0 (no disability) to 100 (maximum disability).~The SGRQ total score summarizes the impact of airway specific disease on overall health status. Scores range from zero (no impairment) to 100 (maximum impairment). Scores were calculated using the SGRQ scoring Algorithm."|Change from Baseline and 1 Month|Participants were analyzed using the intent to treat method and included those that had SGRQ data at baseline and 1 month.|||Units on a scale||Standard Deviation|Mean
2804179|NCT00493974|Secondary|Treatment Failure|Treatment failure is defined as death, intubation, readmission to a hospital for COPD, urgent visit to an outpatient or ED provider for symptoms of COPD or intensification of therapy [including second course of antibiotics for COPD, and second course of systemic steroids for COPD]) in the first 30 days after randomization.|Baseline to day 30 visit|Participants were analyzed following intention to treat (ITT) method.|||Participants|||Number
2804180|NCT00493974|Secondary|Change in FEV1/FEV6 Levels|Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.|from baseline to day of discharge|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline and missing discharge data.|||ratio||Standard Error|Mean
2804252|NCT00493064|Primary|Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.|improvement with combination of niacin and topical prednisolone acetate|one year||||Participants|||Count of Participants
2804181|NCT00493974|Secondary|Change in FEV1% Predicted|Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.|Measured at Baseline and Day 30|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline.|||percent predicted||Standard Error|Mean
2804182|NCT00493974|Primary|Length of Hospital Stay|Admission will begin at the time the subject has been admitted to an inpatient service. Length of Stay (LOS) will be recorded in days. The LOS will be based on the number of days spent in an acute medical ward or in the ICU. Subjects that are admitted and discharged in the same 24 hour period will be recorded as a LOS of 1 day, as will subjects discharged in the ensuing 24 hour period. LOS's greater than 10 days will be truncated to 10 days.|Measured at Day 30|"Participants were analyzed following intention to treat (ITT) method.~One participant randomized to Zileuton withdrew consent before hospital discharge.~Days to discharge are set at a maximum of 10 days."|||Days||Standard Deviation|Median
2804183|NCT00493805|Secondary|Sustained Virological Response (PCR 24 Weeks After End of Treatment)|Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay.|Up to 24 weeks following 48 or 72 weeks of therapy|Information on PCR was available for 7 participants in the non interventional study arm and 11 participants in the interventional study arm.|||Participants|||Number
2804184|NCT00493805|Primary|Early Virological Response in Participants With and Without Insulin Resistance|Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.|At Week 12 (after start of therapy)|"Interventional arm: At baseline, PCR measurements for 38 out of 42 participants were available.~Non Interventional arm: At baseline, PCR measurements for 15 out of 17 participants were available."|||Participants|||Number
2804185|NCT00493779|Secondary|Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Throughout 4-week follow-up period|All enrolled patients in whom clopidogrel treatment was discontinued.|||Participants|||Number
2804186|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Hs-CRP|ANCOVA models performed on log scale controlling for site & natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.|||percent change||Standard Error|Mean
2804187|NCT00493779|Primary|Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)|Based on ANCOVA models performed on log scale controlling for site & natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.|Week 1, Week 2, Week 3, Week 4 (primary timepoint)|Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.|||percent change||Standard Error|Mean
2804188|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin|Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.|||percent change||Standard Error|Mean
2804189|NCT00493649|Secondary|OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.|||probability of overall survival||95% Confidence Interval|Number
2804190|NCT00493649|Secondary|DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.|||probability of disease-free survival||95% Confidence Interval|Number
2804191|NCT00493649|Secondary|Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.|||probability of overall survival||95% Confidence Interval|Number
2804192|NCT00493649|Primary|Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.|||probability of disease-free survival||95% Confidence Interval|Number
2804193|NCT00493636|Secondary|Duration of Overall Response|Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.||||Days||95% Confidence Interval|Median
2804194|NCT00493636|Secondary|Overall Response Rate|Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.||||percentage of participants|||Number
2804195|NCT00493636|Secondary|Time to Progression||Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.||||Days||95% Confidence Interval|Median
2804196|NCT00493636|Secondary|Overall Survival||From the date of randomization to date of death due to any cause, assessed up to 56 months.||||Days||95% Confidence Interval|Median
2804197|NCT00493636|Primary|Progression Free Survival||From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.||||Days||95% Confidence Interval|Median
2804198|NCT00493454|Primary|Objective Response Rate|Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.|Evaluation 4 weeks after administration of Zevalin up to 3 years|One participant did not receive treatment and was excluded from analysis.|||proportion of participants|||Number
2804199|NCT00493311|Secondary|Global Assessment of Treatment at T360 Minutes or Early Termination.|"Subject Global Evaluation was assessed by subject using a 4 point categorical scale in response to the following question:Overall, how would you rate the study treatments? 0 = Poor~= Fair~= Good~= Excellent"|Baseline (T0) to 6 hours||||participants|||Number
2804200|NCT00493311|Secondary|The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)||360 minutes (6 hours after study drug administration)||||Percentage of participants|||Number
2804201|NCT00493311|Secondary|Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)||Baseline (T0) to 360 minutes (6 hours) post study drug administration||||Degrees celsius||Standard Deviation|Mean
2804202|NCT00493311|Secondary|Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.|WSTD3 is defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through the first 3 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 3 hours||||Degrees Celsius||Standard Deviation|Mean
2804203|NCT00493311|Primary|Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever|The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 6 hours post study drug administration||||Degrees Celsius||Standard Deviation|Mean
2804204|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|||participants|||Number
2804205|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|||participants|||Number
2804206|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|||participants|||Number
2804207|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.|||participants|||Number
2804208|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.|||participants|||Number
2804209|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.|||participants|||Number
2804210|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804211|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804212|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804213|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804214|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804215|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804216|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804217|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline|Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.|||GMT||95% Confidence Interval|Mean
2804218|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804219|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804220|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804531|NCT00490841|Secondary|9 Month Blood Pressure (Diastolic)|As compared to baseline. See Population description.|9 months and baseline|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||mmHg||95% Confidence Interval|Mean
2804221|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804222|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804223|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804224|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804225|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804226|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804227|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804228|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804229|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804230|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.|The shedding population included all subjects who received investigational product and had any valid shedding data.|||participants|||Number
2804231|NCT00493285|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later|Safety population was participants who received investigational product and had any safety follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).|||participants|||Number
2804232|NCT00493285|Primary|Number of Participants With Serious Adverse Events (SAEs)|Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.|Days 0-28 after any dose|The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
2804233|NCT00493285|Primary|Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)|An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.|Days 0 to 180 days after final dose or the end of the RSV season, whichever was later|The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.|||participants|||Number
2804234|NCT00493285|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
2804235|NCT00493285|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
2804698|NCT00489918|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24|Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24|24 weeks|Intent to treat (ITT)/Safety Population|||percent change||Standard Deviation|Mean
2804236|NCT00493285|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.|||participants|||Number
2804237|NCT00493285|Primary|Number of Participants With SEs After Dose 3|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
2804238|NCT00493285|Primary|Number of Participants With SEs After Dose 2|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.|||participants|||Number
2804239|NCT00493285|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose|||participants|||Number
2804240|NCT00493246|Secondary|Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)|A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen that; Results in Death, Is life-threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is an important medical event|First dose to 30 days following last dose of study medication|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.|||Participants|||Number
2804241|NCT00493246|Secondary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication|First dose of study medication to 30 days after the last dose of study medication||||Participants|||Number
2804242|NCT00493246|Primary|Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen|t1/2: Terminal elimination half-life|48hrs|"Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the last dose of IV acetaminophen.~Due to only one subject in the Neonate 15mg/kg group, t1/2 (h) was not calculated."|||Hours||Full Range|Median
2804243|NCT00493246|Primary|Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen|AUC 0-t (µg*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.|Time Zero (just prior to first dose) to 48 hours post first dose||||µg*h/ml||Full Range|Median
2804244|NCT00493246|Primary|Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen|Tmax: Time to reach maximum plasma concentration (Cmax)|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.|||Hour||Full Range|Median
2804245|NCT00493246|Primary|Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen|Cmax: Maximum Plasma Concentration|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.|||micrograms per milliliter (µg/mL)||Full Range|Median
2804246|NCT00493220|Primary|AUC0-inf|Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)|from the start of ceftriaxone administration to infinity|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||µg*hr/mL||Standard Deviation|Mean
2804247|NCT00493220|Primary|AUC0-t|Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)|Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||μg*hr/mL||Standard Deviation|Mean
2804248|NCT00493220|Secondary|Tmax|Time to maximum measured plasma ceftriaxone concentration|from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||hr||Full Range|Median
2804249|NCT00493220|Secondary|Cmax|Maximum measured plasma ceftriaxone concentration|at the time of the highest measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)|||µg/mL||Standard Deviation|Mean
2804250|NCT00493181|Primary|Number of Participants With Complete Response|Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.|Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)||||Participants|||Number
2804251|NCT00493064|Secondary|A Decrease in the Thickness of the Retina|data not available|one year|Although data for this outcome measure was collected, however, data are not available. The PI is retired and no longer works in the organization. Sincere efforts were made to obtain the data, however, no data are available for this outcome.||||||
2804253|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|End of Follow-up, Day 24-30 after treatment|Patients valid per protocol with a causative organism cultured.|||Participants|||Number
2804254|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|At 'Test-of-Cure', Day 1-3 after treatment|Patients valid per protocol with a causative organism cultured.|||Participants|||Number
2804255|NCT00493038|Secondary|Number of Participants With Response (Per-protocol Population)|"Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as continued clinical cure"|End of Follow-up, Day 24-30 after treatment|PP population at end FU: (1) Clinical evaluation was performed at the TOC visit (2) No other systemic antibacterial agent was administered with study drug up to the TOC visit (3) Adequate treatment compliance (≥80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy (6) FU assessment available|||participants|||Number
2804256|NCT00493038|Secondary|Number of Participants With Response (Intent-to-treat Population)|"Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as clinical cure"|At 'Test-of-Cure', Day 1-3 after treatment|ITT population: participants having at least one observation under study medication|||participants|||Number
2804257|NCT00493038|Primary|Number of Participants With Response (Per-protocol Population)|"Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as clinical cure"|At 'Test-of-Cure', Day 1-3 after treatment|Per Protocol population: subjects to meet all of the following (1) Clinical evaluation was performed at TOC visit (2) No other systemic antibacterial agent was administered with study drug up to TOC visit (3) Adequate treatment compliance (≥ 80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy|||participants|||Number
2804258|NCT00493025|Secondary|Correlation Between EGFR Pathway Component Expression and Activation With Pathologic Complete Response and Survival||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
2804259|NCT00493025|Secondary|Survival||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
2804260|NCT00493025|Secondary|Time to Progression||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
2804261|NCT00493025|Secondary|Safety and Tolerability of This Regimen||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
2804262|NCT00493025|Secondary|Toxicity as Assessed by NCI CTC v2.0||5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
2804263|NCT00493025|Primary|Pathologic Complete Response Rate to the Neoadjuvant Regimen|Study closed due to early stopping rule. Patient data was not analyzed. No additional information is available to report|5 years|Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure||||||
2804264|NCT00493012|Secondary|Change in Hb A1c From Baseline to 12 Months||change from baseline to 12 months||||% glycosylated hemoglobin||Standard Deviation|Mean
2804265|NCT00493012|Secondary|Change in Proinsulin From Baseline to 12 Months||baseline, 12 months||||pmol/l||Standard Deviation|Mean
2804266|NCT00493012|Secondary|Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months||baseline, 12 months||||pg/ml||Standard Deviation|Mean
2804267|NCT00493012|Secondary|Change in C-reactive Protein From Baseline to 12 Months||baseline, 12 months||||mg/l||Standard Deviation|Mean
2804268|NCT00493012|Secondary|Change in LDL-cholsterol From Baseline to 12 Months||baseline, 12 months||||mmol/l||Standard Deviation|Mean
2804269|NCT00493012|Secondary|Change in Triglycerides From Baseline to 12 Months||baseline, 12 months||||mmol/l||Standard Deviation|Mean
2804270|NCT00493012|Secondary|Change in Parathyroid Hormone From Baseline to 12 Months||baseline, 12 months||||pmol/l||Standard Deviation|Mean
2804271|NCT00493012|Secondary|Change in Calcitriol From Baseline to 12 Months||baseline, 12 months||||pmol/l||Standard Deviation|Mean
2804272|NCT00493012|Secondary|Change in 25-hydroxyvitamin D From Baseline to 12 Months||baseline, 12 months||||nmol/l||Standard Deviation|Mean
2804273|NCT00493012|Secondary|Change in Fat Mass From Baseline to 12 Months||baseline, 12 months||||kg||Standard Deviation|Mean
2804274|NCT00493012|Primary|Change in Body Weight From Baseline to 12 Months||baseline, 12 months||||kg||Standard Deviation|Mean
2804275|NCT00492973|Primary|Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.||any point during the first postoperative year||||Number of participants with complication|||Number
2804276|NCT00492973|Primary|Patient Satisfaction||6 weeks, 3 months, and 1 year postoperative|||||||
2804277|NCT00492973|Primary|Amount of Pain Medication Taken Per Day||Average of 3 days after surgery||||mg/day morphine equivalant||Standard Deviation|Mean
2804278|NCT00492973|Primary|Knee Society Scores|The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.|3 months postoperative||||units on a scale||Standard Deviation|Mean
2804279|NCT00492973|Primary|Knee Range of Motion||3 months||||degrees||Standard Deviation|Mean
2804280|NCT00492973|Primary|Length of Hospital Stay||days after surgery||||days||Standard Deviation|Mean
2804532|NCT00490841|Secondary|9 Month Blood Pressure (Systolic)|As compared to baseline (pre-procedure). Blood pressure measurements at 9 months.|Baseline (Pre-Procedure) and 9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||mmHg||95% Confidence Interval|Mean
2804281|NCT00492921|Primary|GVHD Response Rate|Percentage of patients whose GVHD (as defined by Przepiorka criteria) responded to cyclophosphamide (complete response). Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).|Day 28|This analysis excludes the two participants who died early because their responses were not assessed prior to death.|||Participants|||Count of Participants
2804282|NCT00492921|Primary|Maximum Tolerated Dose of High-dose Cyclophosphamide as Determined by Number of Participants Who Tolerated Each Dose of Cyclophosphamide||Day 28||||Participants|||Count of Participants
2804283|NCT00492856|Primary|3-year Disease-free Survival (DFS) Rate|DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient > 10^-5 based on RT-PCR performed at appropriate central lab.|Up to 3 years|Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included.|||percentage of patients|||Number
2804284|NCT00492856|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.|||Participants|||Number
2804285|NCT00492752|Secondary|Time of Maximum Concentration (Tmax) After 21 Days of Sorafenib Treatment|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||hours||Full Range|Median
2804286|NCT00492752|Secondary|Normalized Maximum Concentration (Cmaxnorm) After 21 Days of Sorafenib Treatment|Cmaxnorm refers to the maximum plasma concentration of Sorafenib corrected for dose and body weight (Cmaxnorm = Cmax/(mg/kg)).|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||g/mL||Full Range|Geometric Mean
2804287|NCT00492752|Secondary|Maximum Concentration (Cmax) After 21 Days of Sorafenib Treatment|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||mg/L||Full Range|Geometric Mean
2804288|NCT00492752|Secondary|Normalized Area Under the Curve (AUC Norm) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||g*h/L||Full Range|Geometric Mean
2804289|NCT00492752|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.|||mg*h/L||Full Range|Geometric Mean
2804290|NCT00492752|Secondary|Time to Response|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) ) was defined as the time from date of randomization to the earliest date that the response was first documented.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The time to response was measured for the ITT population.|||days||Full Range|Median
2804291|NCT00492752|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented, or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last tumor assessment.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The duration of response was measured for the ITT population.|||days||Full Range|Median
2804292|NCT00492752|Secondary|Number of Participants With Different Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed* Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to sorafenib treatment|The tumor response was measured for the ITT population.|||participants|||Number
2804293|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment|"The FACT-Hep questionnaire was also completed to assess patient reported outcome. The FACT-Hep assesses hepatobiliary cancer-related quality of life. FACT-Hep total score ranges from 0 to 180 (0=All questions answered Not at all; 180=All questions answered Very much)."|Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FACT-Hep score changes from baseline by visit were assessed for the ITT population.|||scores on a scale||Standard Deviation|Mean
2804294|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3|The FHSI-8 questionnaire was completed at baseline and every 3 weeks during treatment and at the end of treatment visit only for subjects who withdrew for reasons other than symptomatic progression. Patient reported outcome was measured using the FHSI-8 score changes from baseline throughout the study period. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms)..|Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FHSI-8 score changes from baseline by visit were assessed for the ITT population.|||scores on a scale||Standard Deviation|Mean
2804295|NCT00492752|Secondary|Disease Control|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD: an increase in the sum of tumor lesions sizes) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR: disappearance of tumor lesions) + total number of Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes) + total number of Stable Disease (SD: steady state of disease); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating).|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Disease control rate was measured for the ITT population (all randomized subjects)|||participants|||Number
2804296|NCT00492752|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiologically documented disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation。|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of 09 Aug 2007 (23 months after randomization).|||days||95% Confidence Interval|Median
2804297|NCT00492752|Secondary|Time to Symptomatic Progression (TTSP)|Time to Symptomatic Progression (TTSP) was defined as the time from date of randomization to symptomatic progression. Subjects without symptomatic progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to Symptomatic Progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of of 09 Aug 2007 (23 months after randomization)|||days||95% Confidence Interval|Median
2804298|NCT00492752|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 09 Aug 2007 (23 months after randomization).|||days||95% Confidence Interval|Median
2804299|NCT00492726|Secondary|Duration of Hospitalization Postoperatively|Duration of hospitalization after the first surgery until discharge in the per protocol population.|Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.|||days||Standard Deviation|Mean
2804300|NCT00492726|Secondary|Duration of Hospitalization|Duration of hospitalization in the per protocol population.|From the first admission date to the discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.|||days||Standard Deviation|Mean
2804301|NCT00492726|Secondary|Number of Subjects Who Died Due to Intra-abdominal Infections|Number of subjects who had died due to intra abdominal infections by the time of TOC visit.|21 - 28 days after end of treatment at TOC Visit|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
2804313|NCT00492648|Secondary|Anti-VZV Ab Concentrations|As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2804302|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).|||participants|||Number
2804303|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection' - additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).|||participants|||Number
2804304|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.|After 5 - 14 days of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). For one patient in the Moxifloxacin group, the data is missing due to missing EOT visit (not displayed in the table below).|||participants|||Number
2804305|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population|Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|after 5 - 14 days of therapy|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
2804306|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.|During treatment at day 5 +/- 1 day|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).|||participants|||Number
2804307|NCT00492726|Secondary|Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population|Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|During treatment at day 5 +/- 1 day|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
2804308|NCT00492726|Primary|Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 to 28 days after completion of study drug therapy|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subjects with no major protocol deviations that would have influenced the primary outcome.|||participants|||Number
2804309|NCT00492648|Secondary|Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes|This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash.|From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.|The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study.|||Participants|||Count of Participants
2804310|NCT00492648|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|From Month 30 to study end Month 42 after the first vaccination|The analysis was performed on the Total cohort for persistence which included all subjects previously primed with 2 doses of GSK1437173A and were enrolled in the current study.|||Participants|||Count of Participants
2804311|NCT00492648|Secondary|Frequencies of VZV-specific Memory B Cells|As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||VZV-specific B-cells/million B-cells||Standard Deviation|Mean
2804312|NCT00492648|Secondary|Frequencies of gE-specific Memory B Cells|As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||gE-specific B-cells/million B-cells||Standard Deviation|Mean
2804314|NCT00492648|Secondary|Anti-gE Antibody (Ab) Concentrations|As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).|At months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2804315|NCT00492648|Secondary|Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression.|The analysis focused on those gE- and VZV-specific CD4 T cells secreting any cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected.|At Months 30 and 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||CD4 cells/million T-cells||Standard Deviation|Mean
2804316|NCT00492648|Primary|Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).|The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.|At Month 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||VZV-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
2804317|NCT00492648|Primary|Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).|The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.|At Month 42 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||gE-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
2804318|NCT00492648|Primary|Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).|The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.|At Month 30 after the first vaccination|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||VZV-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
2804319|NCT00492648|Primary|Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L).|The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.|At Month 30 after the first vaccination.|The analysis was based on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for the assay and time point assessed.|||gE-specific CD4 cells/million CD4 cells||Standard Deviation|Mean
2804320|NCT00492622|Primary|Area Under the Curve for Omeprazole Plasma Concentration|The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.|0 to 5 hrs after the study drug was ingested on treatment day 7|the AUC for each formulation were combined regardless of order given|||mg*h/mL||Standard Deviation|Mean
2804321|NCT00492622|Primary|Maximal Concentration of Omerazole|Maximal concentration of immediate-release vs. delayed-release omeprazole|10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment|All subjects were included, regardless of which formulation they received first.|||ng/mL plasma||Standard Deviation|Mean
2804322|NCT00492622|Primary|Time to Maximal Omeprazole Concentration (Tmax)|Time to max concentration for Immediate release vs. Delayed release omeprazole|10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment|All subjects were included regardless of which formulation they received first.|||minutes||Standard Deviation|Mean
2804323|NCT00492583|Primary|Number of Days Children Are Out of School Sick|"Outcome measure, number of days children are out of school sick was measured for the entire population"|90 days||||days per 100 person days|||Number
2804324|NCT00492557|Post-Hoc|13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2804325|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events|Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.|||Percentage of participants|||Number
2804326|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.|||percentage of participants|||Number
2804327|NCT00492557|Primary|13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)|IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2804328|NCT00492557|Primary|TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)|Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.|Baseline and 1 month after TIV vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2804329|NCT00492544|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|"Abnormalities include values outside (above or below) the normal ranges.~Normal ranges:~alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL"|At Day 0 and Month 7||||Participants|||Count of Participants
2804330|NCT00492544|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7||||Participants|||Count of Participants
2804331|NCT00492544|Secondary|Outcome of All Pregnancies|According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.|Up to Month 7|There were no pregnancies reported between Day 0 and Month 7 in the Total Vaccinated Cohort.||||||
2804332|NCT00492544|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.|From Day 0 up to Month 7||||Participants|||Count of Participants
2804333|NCT00492544|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination||||Participants|||Count of Participants
2804334|NCT00492544|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination||||Participants|||Count of Participants
2804335|NCT00492544|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Days 0-6) period following each vaccination||||Participants|||Count of Participants
2804336|NCT00492544|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.|||titer||95% Confidence Interval|Geometric Mean
2804337|NCT00492544|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
2804338|NCT00492531|Primary|Change in Exercise Capacity as Assessed by 6 Minute Walk.|The primary outcome measure was change in exercise capacity assessed by 6 minute walk distance in meters from baseline to 16 weeks. Subjects without a week 16 assessment had their last observation carried forward.|Baseline to week 16/Imputed last visit.|All efficacy and safety analyses were conducted on the intent-to-treat (ITT) population, defined as all randomized subjects, regardless of therapy received. Pre-defined imputation rules:A value of 0 meters was imputed for subjects who died during the MIT.Subjects without a week 16 assessment had their last observation carried forward (LOCF).|||meters||Standard Deviation|Mean
2804339|NCT00492531|Secondary|Brain Natriuretic Peptide(BNP)Levels.||16 weeks||||pg/dl||Standard Deviation|Mean
2804340|NCT00492531|Secondary|Borg Dyspnea Score|Borg dyspnea score was used to measure the level of severity of breathlessness perceived by the patient before and after 6 minute walk. The severity is measured on a 10 point scale with 0= nothing at all and 10=maximum severity of breathlessness.|baseline to 16 weeks||||Score on a scale||Standard Deviation|Mean
2804341|NCT00492531|Secondary|Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity|Secondary outcome measure was change from baseline in Pulmonary hypertension at week 16 as assessed by Tricuspid regurgitant jet velocity(TRV). Tricuspid regurgitant jet velocity was measured by transthoracic Doppler Echocardiography.|16 weeks||||meters/second||Standard Deviation|Mean
2804342|NCT00492401|Secondary|Measurement of Gene Expression in Peripheral Blood or Bone Marrow|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed for this trial||||||
2804343|NCT00492401|Secondary|Measurement of HbF in Peripheral Blood or Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to days 28 of course 2|Data was not collected and analyzed for this trial||||||
2804344|NCT00492401|Secondary|Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells|Expression studies were conducted using quantitative RT PCR. Expression of DNMT were normalized to the internal control to the ABL and levels of miR-29 to RNA U44.|Pre treatment|Only pre treatment samples available for testing for 23 patients|||delta delta CT values||Inter-Quartile Range|Median
2804345|NCT00492401|Secondary|Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed||||||
2804346|NCT00492401|Primary|Rate of Complete Remission|Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul. Complete Remission Rate (CRm + CRi)|Up to 24 weeks||||patients|||Number
2804347|NCT00492349|Primary|P50|P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||microvolts||Standard Error|Mean
2804348|NCT00492349|Primary|Antisaccade Error Rates|In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||percentage errors||Standard Deviation|Mean
2804349|NCT00492349|Primary|Conner's Continuous Performance Test (CPT) Detectability Score|Conner's CPT Detectability Score (no set normal range, higher is generally better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||units on a scale||Standard Deviation|Mean
2804350|NCT00492349|Primary|Digit Symbol Test|Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 0, Week 2 and Week 8||||units on a scale||Standard Deviation|Mean
2804351|NCT00492349|Primary|Maintenance Pursuit Gain|Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||velocity ratio||Standard Error|Mean
2804352|NCT00492349|Primary|Predictive Pursuit Gain|Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||velocity ratio||Standard Error|Mean
2804353|NCT00492349|Primary|Memory Saccadic Positional Error, Degrees|A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||degrees||Standard Error|Mean
2804354|NCT00492349|Primary|Hamilton Depression Rating Scale (Ham-D)|Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.|Week 8||||units on a scale||Standard Error|Mean
2804355|NCT00492336|Secondary|Number of Participants Exhibiting Side Effects|"The Side Effect Checklist (SEC) was used to assess side effects. The SEC is comprised of 22 common side effects, which are rated on a 1 (none)-4 (severe) scale. Side effects are determined to be clinically significant if there is a two or more point increase in severity from baseline, or any side effect that receives a severity rating of 4 (severe) at any point in the treatment phase of the study."|Every week for 12 weeks|One placebo patient for whom a baseline side effects checklist was excluded from these analyses.|||Participants|||Count of Participants
2804356|NCT00492336|Secondary|Global Change in Illness Severity|"The Clinical Global Impression (CGI) severity of illness item was used to assess global changes. Scores on this item range from 1=Normal, not at all ill to 7=Among the most extremely ill."|Every 4 weeks for 12 weeks.|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
2804357|NCT00492336|Secondary|Depressive Symptoms|The Calgary Depression Scale (CDS; Addington et al, 1997) total score was used to assess depressive symptoms over the course of the study. Total scores were calculated by summing the scores of each of the 9 items. Total scores can range from 0-27, with higher scores indicating more severe depressive symptoms.|Every 4 weeks for 12 weeks.|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
2804358|NCT00492336|Secondary|Change in Persistent Positive Symptoms|"The Brief Psychiatric Rating Scale (BPRS) positive symptom item total score was used to assess positive symptom change. The BPRS positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating."|Every 4 weeks for 12 weeks.|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
2804359|NCT00492336|Secondary|Number of Participants With Akathisia|The Barnes Akathisia Scale (BAS; Barnes, 1989) was used to assess akathisia, a type of extrapyramidal symptom. The global clinical assessment of akathisia score is rated on a scale from 0=Absent to 5=Severe Akathisia.|Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Barnes Akathisia Scales at baseline and end of study were collected for 26 participants each in the rasagiline and placebo groups. End of study ratings were collected at week 12, except for 4 placebo participants (1 participant each at weeks 3 and 6, and two at week 8).|||Participants|||Count of Participants
2804360|NCT00492336|Secondary|Extrapyramidal Symptoms|The Simpson Angus Scale (SAS; Simpson and Angus, 1970) was used to assess extrapyramidal symptoms (EPS). The assessment consists of 11 items, each rating the severity of potential symptoms of movement disorders. Total scores are calculated by summing the scores of each of the 11 items for a potential total score of 0-44, with higher scores indicating more severe EPS.|Baseline (Week 0) and End of Study (Week 12)|SAS scores were collected at baseline on 28 Rasagiline and 29 Placebo patients. End of study scores were collected on 27 Rasagiline and 27 Placebo patients, including 5 patients who withdrew before Week 12 (1 Rasagiline patient at Week 4, 1 Placebo participant each at Weeks 3 and 6, and two Placebo participants at Week 8).|||units on a scale||Standard Deviation|Mean
2804361|NCT00492336|Primary|Cognitive Testing - Delayed Discounting|The monetary choice questionnaire for hypothetical monetary rewards was used to assess delayed discounting (Kirby et al, 1999). The measure includes 27 items in which participants choose between a smaller, immediate reward (SIR) and a larger, delayed reward (LDR). There are three LDR sizes: small ($25-35), medium ($50-60) and large ($75-85). By examining the pattern of choices that participants make across the set of 27 items it is possible to calculate their delay discounting rate, termed K. The discount rate determines the steepness of the reduction in the present value of a reward with increases in the delay to the possible receipt of that reward. Thus, higher values in K represent greater discounting of the value of future rewards. With this measure K values can range between a low of 0.00016 to a high of 0.25. Higher K values have been linked to measures of impulsivity. Shown in the table are the K values observed when the future rewards were small, medium, or large.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points.|||units on a scale||95% Confidence Interval|Geometric Mean
2804362|NCT00492336|Primary|Cognitive Testing - Probabilistic Learning Task|To assess reward learning, participants used performance feedback to choose the most frequently rewarded item in each of three pairs of stimuli (one pair had reward probabilities: 80% vs 20%; one pair had reward probabilities of 70% vs 30%; one pair had the probabilities of 60% vs 40 %) (PL; Frank et al, 2004). A total of 240 trials were administered so each pair was seen 80 times. Higher scores represent more frequent choices of the optimal stimulus in each pair. The frequencies with which participants repeated an item choice that was rewarded on the previous presentation (win-stay) is also presented as a percentage. Similarly, the lose-shift score is the percentage of times that participants changed their choice for unrewarded items (lose-shift). The win-stay score serves as a measure of the impact of positive feedback on subsequent choices while the lost-shift score serves as a measure of the impact of negative feedback on subsequent choices.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points. Results for lose shifts are calculated for 24 Rasagiline and 22 Placebo participants, due to missing data created by participants who had zero losses (and hence no need to shift) during both the 3rd and 4th blocks of trials.|||percentage of optimal stimuli chosen||Standard Deviation|Mean
2804363|NCT00492336|Primary|Cognitive Testing - N-Back Neurocognitive Task|The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points.|||units on a scale||Standard Deviation|Mean
2804364|NCT00492336|Primary|Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score|The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Beginning of treatment phase (week 0) and end of treatment phase (week 12)|Subjects completing the cognitive testing at both time points.|||units on a scale||Standard Deviation|Mean
2804365|NCT00492336|Primary|Change in Negative Symptoms|"The Scale for the Assessment of Negative Symptoms (SANS) rating scale was used to assess the negative symptoms of schizophrenia. Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0=Not at all to 5=Severe. Every 4 weeks the summed subscale scores provide a total score for that week (0-85). Higher scores indicate more severe negative symptoms."|Every 4 weeks over a 12 week period|Number of participants available for symptom efficacy analyses.|||units on a scale||Standard Deviation|Mean
2804380|NCT00492284|Secondary|Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||Percentage of participants||95% Confidence Interval|Mean
2804366|NCT00492297|Secondary|Time to Progression|Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD.|From start of treatment until progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Of these 83, 78 were included in this analysis.|||days||95% Confidence Interval|Median
2804367|NCT00492297|Secondary|Time to Response|Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented.|start of therapy to confirmed CR or PR (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.|||days||95% Confidence Interval|Median
2804368|NCT00492297|Secondary|Duration of Stable Disease|Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment.|from start of therapy to PD, only in non-responders (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 70 subjects who had a Best Response of Stable Disease, ie, those who failed to achieve a Best Response of CR or PR, were included in this analysis.|||days||95% Confidence Interval|Median
2804369|NCT00492297|Secondary|Disease Control (DC)|DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point.|after start of treatment, at 6 months and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||participants|||Number
2804370|NCT00492297|Secondary|Duration of Partial Response|Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed PR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 9 subjects who had a PR were included in this analysis.|||days||95% Confidence Interval|Median
2804371|NCT00492297|Secondary|Duration of Complete Response|Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed CR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 1 subject who had a CR was included in this analysis (duration 420 days, censored).|||days|||Number
2804372|NCT00492297|Secondary|Duration of Response|Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment.|from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.|||days||Full Range|Median
2804373|NCT00492297|Secondary|Overall Survival|Overall Survival was the number of days from the date that combination treatment started until the date of death.|from start of treatment until death (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||days||95% Confidence Interval|Median
2804374|NCT00492297|Secondary|Percentage of Subjects With Progression-free Survival at Specific Time-points|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression after 3, 6 and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||percentage of participants|||Number
2804375|NCT00492297|Secondary|Progression-free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.|||days||95% Confidence Interval|Median
2804376|NCT00492297|Primary|Overall Best Response|Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.|during or within 30 days after active therapy|There were 83 subjects in the intent-to-treat (ITT) population. Of these, 75 were evaluable for Best Response; 8 were not evaluable.|||participants|||Number
2804377|NCT00492284|Secondary|Mean Change From Baseline in Lesion Size|Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion|Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||micron||Standard Deviation|Mean
2804378|NCT00492284|Secondary|Mean Change From Baseline in Central Retinal Thickness||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||micron||Standard Deviation|Mean
2804379|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward|||Percentage of participants||95% Confidence Interval|Mean
2804383|NCT00492284|Secondary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 24|Intent-to-treat|||number of retreatments||95% Confidence Interval|Mean
2804384|NCT00492284|Primary|Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 12|Intent-to-treat and last observation carried forward|||Letters read on ETDRS chart||95% Confidence Interval|Mean
2804385|NCT00492284|Primary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 12|Intent-to-treat|||number of retreatments||95% Confidence Interval|Mean
2804386|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%.|Baseline and Weeks 1-10|Analysis was performed on all subjects who were randomized and received at least 1 dose of double-blind medication during the study. Subjects were analyzed by the treatment they were randomized to receive.|||participants|||Number
2804387|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%.|Baseline and Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||participants|||Number
2804388|NCT00492232|Secondary|Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation|Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized.|Weeks 1-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, had completed the DBTP, and had sufficient zolpidem dosage data in the last 7 days of the DBTP. Estimates could not be reported with correct statistical inference due to small sample sizes by method of discontinuation (ie, most subjects reduced zolpidem dose).|||participants|||Number
2804389|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10|The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
2804390|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8|The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
2804391|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6|The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
2804392|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4|The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
2804393|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2|The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||nights per week||Standard Error|Least Squares Mean
2804394|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10|Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
2804395|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8|Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
2804396|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6|Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
2804397|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4|Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
2804398|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2|Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Dose (mg)||Standard Error|Least Squares Mean
2804399|NCT00492232|Primary|Percentage of Participants Who Discontinued Zolpidem Therapy|Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.|Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.|||Percentage of participants|||Number
2804400|NCT00492206|Secondary|EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase|EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.|approx. 5 years|Participants with baseline tumor tissue available for EGFR status analysis by fluorescence in situ hybridization (FISH). Akt, pAkt, and MAPKinase analyses were not conducted.|||percentage of tumors|baseline tumor tissue||Number
2804401|NCT00492206|Secondary|Best Overall Response Rate (ORR) (Number of Participants)|The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 12 weeks after treatment initiation|Patients who received concurrent radiotherapy + cetuximab + consolidation therapy, and patients who did not receive cetuximab|||participants|||Number
2804402|NCT00492206|Secondary|Progression-free Survival (PFS)|Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC.|||months||95% Confidence Interval|Median
2804403|NCT00492206|Primary|Overall Survival (OS)||Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC (N = 38).|||months||95% Confidence Interval|Median
2804404|NCT00492115|Secondary|Sleep Stages; %Time Spent at SaO2<90%;|Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.|6 weeks||||Percent time spent at low oxygen <90%||Standard Deviation|Mean
2804405|NCT00492115|Primary|Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)|Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)|six weeks||||apnea hypopnea index||Standard Deviation|Mean
2804406|NCT00492089|Primary|Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment|Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.|Baseline to 12 weeks|Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.|||participants|||Number
2804407|NCT00492063|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.|Up to 7 days postvaccination|Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data.|||Number of Subjects|||Number
2804429|NCT00491608|Secondary|Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29|Laboratory findings considered clinically significant by investigator when associated with symptoms, required specific treatment, or required a change in participant management. Clinically significant changes in vital signs were reported as adverse events.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery.|||Participants|||Number
2804408|NCT00492063|Primary|Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.|||Ratio||95% Confidence Interval|Number
2804409|NCT00492063|Primary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV|Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.|||Percentages||95% Confidence Interval|Number
2804410|NCT00492063|Primary|Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines|"Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.~In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group."|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding.|||Percentages||95% Confidence Interval|Number
2804411|NCT00492024|Other Pre-specified|Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure', Day 1-5 after end of treatment|This analysis population was per protocol population, which included all subjects with at least one pre-treatment causative organism, and who had no major deviations from the protocol procedures.|||Percentage of subjects|||Number
2804412|NCT00492024|Secondary|Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up|A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 12 to 26 after end of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||Percentage of subjects|||Number
2804413|NCT00492024|Secondary|Percentage of Subjects With Clinical Improvement During Therapy|A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 3 of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. Missing responses at during therapy visit in most cases was due to early clinical failure.|||Percentage of subjects|||Number
2804414|NCT00492024|Secondary|Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach|The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||participants|||Number
2804415|NCT00492024|Secondary|Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach|The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||participants|||Number
2804416|NCT00492024|Primary|Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment|The modified intent-to-treat (MITT) population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.|||Percentage of subjects|||Number
2804443|NCT00491556|Secondary|Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo HLA-DR cells||Standard Deviation|Mean
2804417|NCT00491894|Secondary|Investigator's Global Assessment of Treatment|The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder' (neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for investigator's Global Assessment was done by intention to treat method|||Participants|||Number
2804418|NCT00491894|Secondary|Parent/Caregiver's Global Assessment of Treatment|The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder'(neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for parent/caregiver's Global Assessment was done by intention to treat method|||Participants|||Number
2804419|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using VAS|"Parents/caregivers were to complete a 10 cm Parent/Caregiver's Assessment of Extent of Drooling for the Day VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day."|Week 24||||VAS score||Standard Deviation|Mean
2804420|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)|"Parents/caregivers were to complete a 10 cm Parent/Caregiver's Assessment of Extent of Drooling for the Day VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day."|Baseline||||VAS score||Standard Deviation|Mean
2804421|NCT00491894|Primary|Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS)|The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline|6 months|The analysis was done by intention to treat method. For purposes of statistical estimation, patients who dropped out due to lack of efficacy had their worst observation carried forward. Patients who dropped out for reasons other than lack of efficacy had their last observation carried forward|||Participants|||Number
2804422|NCT00491829|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|"To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered yes to the eDiary question: Was the event satisfying for you?"|baseline to 24 weeks|Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.|||events per month||Standard Deviation|Mean
2804423|NCT00491764|Secondary|Treatment Success of Onychomycosis at Week 48|Treatment success was defined as negative mycology (negative culture and negative KOH) and =<10% nail involvement.|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication|||Participants|||Number
2804424|NCT00491764|Secondary|Effective Treatment of Onychomycosis at Week 48.|Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or >5 mm growth of unaffected nail|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication|||Participants|||Number
2804425|NCT00491764|Primary|Complete Cure of Onychomycosis at Week 48.|Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication|||Participants|||Number
2804426|NCT00491751|Secondary|Percentage Change in FMD in All Participants With and Without a CVD Event (Not by Treatment Group)|This outcome is independent of the treatment group so the groups are 'CVD event' and ' No CVD Event'. Cardiovascular events (CVD) included cardiovascular disease, myocardial infarction, congestive heart failure, stroke, and unstable angina.|2 months|For this outcome all participants were stratified into 2 groups: those with, and those without a CVD event (not by treatment group)|||percent change of flow-mediated dilation||Standard Deviation|Mean
2804427|NCT00491751|Primary|Change in FMD|Change in flow mediated dilation with treatment: FMD visit 2 - FMD visit 1 FMD is measured by using vascular ultrasound to determine the baseline diameter of the brachial artery. Endothelium-dependent vasodilation is induced by 5-minute arterial occlusion with a blood pressure cuff. When the cuff is released, the resultant increase in blood flow (reactive hyperemia) stimulates vasodilation of the brachial artery. This flow-mediated dilation (FMD) is expressed as the percent change from baseline. Healthy individuals typical dysplay a 10 to 12% dilation. Individuals with PAD had markedly impaired dilation of 6-7. The currernt study sought to determine whether a change in FMD would occur following intervention.|1-4 weeks|All enrolled subjects were analyzed.|||percent change of FMD||Standard Deviation|Mean
2804428|NCT00491738|Primary|All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)|Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.|5 months||||participants|||Number
2804444|NCT00491556|Secondary|Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRO HLADR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRO HLADR||Standard Deviation|Mean
2804430|NCT00491608|Secondary|Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29|Abnormal laboratory findings were recorded as AEs when the investigator considered them to be clinically significant (eg, an unusual result for the surgical population or for an individual participant) or when they were associated with symptoms or required treatment or a change in patient management.|Baseline and Day 29 (end of study)|All participants who received rThrombin and had both baseline and postbaseline antibody assessments available.|||Participants|||Number
2804431|NCT00491608|Secondary|Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29|Activated partial thromboplastin time (aPTT) elevations: Grade 3=>2*upper limit of normal (ULN). International normalized ratio(INR)elevations: Grade 3=>2*ULN. Changes in prothrombin time were not graded for toxicity. n=Number of participants with assessments available at that visit.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery and had laboratory test results available for assessment.|||Participants|||Number
2804432|NCT00491608|Secondary|Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29|Hemoglobin, low (g/L): Grade 2=<100 Grade 3=<80; Grade 4=<65. Platelets, low: Grade 2=<75*10^9/L; Grade 3=<50*10^9/L; Grade 4=<25*10^9/L. Leukocytes, low: Grade 2=<3.0-2.0*10^9/L; Grade 3=<2.0-1.0*10^9/L; Grade 4=<1.0*10^9/L. Lymphocytes, low: Grade 2=<0.8*10^9/L; Grade 3=<0.5*10^9/L; Grade 4=<0.2*10^9/L. Neutrophils, low: Grade 2=<1.5*10^9/L; Grade 3=<1.0*10^9/L; Grade 4=<0.5*10^9/L. Changes in hematocrit values observed were not graded for severity.|Baseline and Day 29 (end of study)|All participants who who received at least 1 application of rThrombin during surgery and had laboratory test results available for baseline and Day 29 visits.|||Participants|||Number
2804433|NCT00491608|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs|AE=a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE=an unfavorable medical event that results in death, persistent or significant incapacity, or drug dependency or abuse; is life-threatening, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to study drug. Treatment-emergent=onset on or after treatment start. Grade (Gr) 1=mild, Gr 2=moderate, Gr 3=severe, Gr 4=life threatening/disabling, Gr 5=death.|Day 1 (surgery) to Day 29 (end of study), continuously|All participants who received at least 1 application of rThrombin during surgery.|||Participants|||Number
2804434|NCT00491608|Primary|Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline|Seropositive=with specific anti-bovine thrombin product antibodies; seronegative=without specific anti-bovine thrombin product antibodies.|At Day 29|Participants who received treatment with rThrombin and had results from both baseline and post-baseline antibody assessments|||Participants|||Number
2804435|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
2804436|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
2804437|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD57cells||Standard Deviation|Mean
2804438|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD57 cells||Standard Deviation|Mean
2804439|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
2804440|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
2804441|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRa CD28 cells||Standard Deviation|Mean
2804442|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Three subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 22 participants.|||percentage of CD8 TemRA CD28 cells||Standard Deviation|Mean
2806728|NCT00474188|Secondary|Tumor Control Rate|"Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.~Study terminated prematurely. Analysis not conducted."|One Year||||Participants||95% Confidence Interval|Mean
2804445|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
2804446|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
2804447|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
2804448|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
2804449|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
2804450|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
2804451|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
2804452|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
2804453|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
2804454|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
2804455|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
2804456|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
2804457|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
2804458|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
2804459|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing HLA-D, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve HLA-DR T cells||Standard Deviation|Mean
2804476|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
2804460|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing Human Leukocyte Antigen-D related (HLA-DR), therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve HLA-DR T-cells||Standard Deviation|Mean
2804461|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
2804462|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
2804463|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
2804464|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
2804465|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 Naïve CD28 Cells||Standard Deviation|Mean
2804466|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||percentage of CD8 naïve CD28 cells||Standard Deviation|Mean
2804467|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
2804468|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
2804469|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
2804470|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
2804471|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
2804472|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
2804473|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ naïve T cells/cubic millimeter||Standard Deviation|Mean
2804474|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD8+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
2804475|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
2804477|NCT00491556|Secondary|Difference in CD4+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
2804478|NCT00491556|Secondary|Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ Effector Memory (TEM)Ro count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
2804479|NCT00491556|Secondary|Difference in CD4+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
2804480|NCT00491556|Secondary|Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Termed Central Memory (TCM) count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
2804481|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
2804482|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.|||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
2804483|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm|||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
2804484|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.|||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
2804485|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 48 and Week 152||152 Weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm|||percentage of CD4+ T cells||Standard Deviation|Mean
2804486|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 0 and Week 48||Week 0 and Week 48|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized to the experimental arm.|||percentage of CD4+ T cells||Standard Deviation|Mean
2804487|NCT00491530|Secondary|Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
2804488|NCT00491530|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
2804489|NCT00491530|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
2804490|NCT00491530|Secondary|Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Standard Deviation|Mean
2804529|NCT00490841|Secondary|Acute Procedure Success|Attainment of a final result of < 30% residual stenosis, as determined by the Angiographic Core Lab.|From beginning of index proceedure to end of index proceedure.||||percentage of participants|Participants|95% Confidence Interval|Number
2804491|NCT00491530|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at week 104 are included.|||percent change||Standard Deviation|Mean
2804492|NCT00491530|Secondary|Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.|||percent change||Full Range|Median
2804493|NCT00491530|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study|All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.|Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.|||percentage of participants|||Number
2804494|NCT00491504|Primary|Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1|Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.|Baseline and 6 hours following initial dosing|Intent to treat population|||score on a scale||Standard Error|Least Squares Mean
2804495|NCT00491400|Secondary|Serum Lipids|Effect of the intervention on total cholesterol, HDL, and triglycerides|8 weeks|Enrollment was insufficient and there are too few subjects for meaningful analysis||||||
2804496|NCT00491400|Primary|Brachial Artery Flow-mediated Dilation|Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.|8 weeks|The number of participants is too few for meaningful analysis.||||||
2804497|NCT00491387|Primary|Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio|24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.|january 2018|||||||
2804498|NCT00491374|Primary|The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)|||The primary outcome measure could not be assessed because no subject received randomized treatment assignment, or any treatment. The study was terminated.||||||Number
2804499|NCT00491322|Primary|Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units|Fibroblast growth factor 23 (FGF23) is a phosphate and vitamin D regulating hormone.|12 weeks||||pg/mL||Standard Deviation|Mean
2804500|NCT00491244|Secondary|Adverse Event (AE)-Related Withdrawal Rate||1.5 year|All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit|||participants|||Number
2804501|NCT00491244|Primary|Sustained Virologic Response (SVR)Rate||1.5 year|All participants were analyzed if they received at least one dose of the study medication|||participants|||Number
2804502|NCT00491179|Secondary|Number of Participants With Histologic Response(HR)|Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes)|1.5 year||||Participants|||Number
2804503|NCT00491179|Primary|1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)|"Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection < 25 IU/mL)~Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events"|1.5 year|Outcome measures:intention-to-treat (ITT) analysis Imputation technique: last observation carried forward|||Participants|||Number
2804530|NCT00490841|Secondary|Acute Device Success|Acute device success is defined as, on a per device basis, the achievement of successful delivery of the assigned device(s)as intended to the designated location.|From beginning of index procedure to end of index proceedure.||||percentage of devices|Participants|95% Confidence Interval|Number
2804504|NCT00491075|Primary|Overall Response|Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.|Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks|One participant did not meet the required 16 week data end point and was excluded from the response evaluation and analysis.|||percentage of participants||95% Confidence Interval|Number
2804505|NCT00490971|Other Pre-specified|Clinical Global Impression - Bipolar Disorder - Severity of Illness (CGI-BP-S): Change From Baseline|The CGI-BP-S rating scale is used to rate the severity of bipolar disorder, including both depressed and manic components, on a 7-point scale ranging from 1 (not ill) to 7 (very severely ill). This scale permits a global evaluation of the subject's bipolar condition at a given time. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Full Range|Median
2804506|NCT00490971|Other Pre-specified|Global Assessment of Functioning (GAF): Change From Baseline|This scale is used when the clinical progress of a subject needs to be assessed in global terms, using a single measure. The GAF scale is rated with respect to psychological, social, and occupational functioning at the time of the assessment only. A higher score indicates a better functioning, with an overall range from 1 to 100. Positive Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Standard Deviation|Mean
2804507|NCT00490971|Other Pre-specified|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS consists of 10 items covering all the important complaints which patient with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Standard Deviation|Mean
2804508|NCT00490971|Other Pre-specified|Young Mania Rating Scale (YMRS): Change From Baseline|This is method by which condition of patient suffering with mania is checked. In this scale patient's condition is assessed using 11 items. A severity rating is assigned to each of 11 items based on the how subject feels of his or her condition and the physicians observation of patients behavior. The range of the scale is 0 to 60. A higher score indicates a more severe condition. Change from baseline (Day 105) in the double‑blind maintenance phase to the last postbaseline assessment.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat|||Scores on the scale||Standard Deviation|Mean
2804509|NCT00490971|Secondary|Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder|Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of depressive symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of depressive symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA period, which included participants who entered the maintenance phase and took at least 1 dose of study medication.|||Days||95% Confidence Interval|Number
2804510|NCT00490971|Secondary|Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder|This was the key secondary efficacy end-point. Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of manic symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of manic symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA phase, which included participants who entered the MA phase and took at least 1 dose of study medication.|||Days||95% Confidence Interval|Number
2804511|NCT00490971|Primary|Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder|Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.|Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set (ITT) in maintenance (MA) phase, which included participants who entered the MA phase and took at least 1 dose of study medication.|||Days||95% Confidence Interval|Number
2804512|NCT00490945|Secondary|VEC-162 Tmax||Night 4||||hour||Standard Deviation|Mean
2804513|NCT00490945|Secondary|VEC-162 Cmax||Night 4||||ng/mL||Standard Deviation|Mean
2804514|NCT00490945|Secondary|VEC-162 AUC||Night 4||||ng*hr/mL||Standard Deviation|Mean
2804515|NCT00490945|Secondary|Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)|"Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt.~Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2."|Night 2 and Night 4|*Placebo N = 7 and 100 mg VEC-162 N = 7|||minutes||Standard Deviation|Mean
2804516|NCT00490945|Primary|Mean Sleep Efficiency|Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.|Night 4 and Night 2|"*N = 6 for 3rd Third of Night Efficiency and N=8 for 1st Third of Night Efficiency~**N = 7 for 3rd Third of Night Efficiency"|||% points||Standard Deviation|Mean
2804517|NCT00490945|Primary|Circadian Phase Shift|Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.|Night 3 and Night 4||||Hours||Standard Deviation|Mean
2804518|NCT00490919|Secondary|The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, 12 of double-blind phase|The full analysis population (FAP) (N = 541) consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. 2 subjects did not have safety data (N = 539).|||Units on a scale||Standard Deviation|Mean
2804519|NCT00490919|Secondary|The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase|Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.|weeks 2-12|Subjects in the full analysis population who took at least one dose of supplemental analgesic medication.|||tablets||Standard Error|Mean
2804520|NCT00490919|Primary|Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.|Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.|Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.|The full analysis population (FAP) (N = 541) [539] consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. (Two subjects did not have safety data.)|||Units on a scale||Standard Deviation|Mean
2804521|NCT00490841|Secondary|Renal Function (Measured by sCr)|"sCR= Serum Creatinine, per subject analysis. ITT. Renal function (measured by sCr) @ baseline: 1.2mg/dL (1.2, 1.3).~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.|||mg/dL||95% Confidence Interval|Mean
2804522|NCT00490841|Secondary|9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications|"Number of Anti-Hypertensive Medications taken at follow up compared to baseline, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to or greater than 4 Medications: 39.6%|||percentage of participants|||Number
2804523|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 3 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 3 Medications: 30.7%|||percentage of participants|||Number
2804524|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 2 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 2 medications: 29.2%|||percentage of participants|||Number
2804525|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 1 Medication|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 1 medication: 0.5%|||percentage of participants|||Number
2804526|NCT00490841|Secondary|Secondary Patency Rate of <60% Stenosis of the Target Lesion|"As determined by duplex ultrasound or angiography regardless of PTA, stenting, or bypass since index procedure. Rate reported as a percentage of participants with this condition.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.|||percentage of participants|Participants|95% Confidence Interval|Number
2804527|NCT00490841|Secondary|Primary Patency|"Defined as <60% stenosis without prior re-intervention, as determined by duplex ultrasound or angiogram.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.|||percentage of participants|Participants|95% Confidence Interval|Number
2804528|NCT00490841|Secondary|Acute Clinical Success|"Procedure success without Major Adverse Events (MAE)or access site event requiring surgical or percutaneous intervention prior to hospital discharge.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|From beginning of index proceedure to end of index proceedure.||||percentage of participants||95% Confidence Interval|Number
2813858|NCT00425308|Secondary|Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12|Change in proteinuria (g/24h) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population|||g/24h||Standard Deviation|Mean
2804533|NCT00490841|Secondary|Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)|Event Free percentage: Defined as percentage of participants free from this event.|9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||Event Free Percentage|||Number
2804534|NCT00490841|Secondary|Embolic Events Resulting in Kidney Damage|Percentage of participants with an embolic event resulting in kidney damage.|30 days|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of participants||95% Confidence Interval|Number
2804535|NCT00490841|Secondary|Ipsilateral Nephrectomy|Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney|30 days|intention to treat (ITT). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants||95% Confidence Interval|Number
2804536|NCT00490841|Secondary|Death for Any Reason||30 days|Non-Hierarchical Subject Counts, Per Subject Analysis (Intent-to-Treat Population). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants||95% Confidence Interval|Number
2804537|NCT00490841|Primary|Binary Restenosis Rate|Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.|9 months|Subject total reflects those who were evaluable at the time of analysis. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.|||Percentage of lesions|Participants|95% Confidence Interval|Number
2804538|NCT00490815|Secondary|Retinal Thickness||over 36 months||||µg||Standard Deviation|Mean
2804539|NCT00490815|Primary|Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor|This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.|over 36 months||||pg/ml||Standard Deviation|Mean
2804540|NCT00490802|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale has been developed to measure autism related symptoms and focuses more on social function than social cognition. The Social Responsiveness Scale has been modified for adults by and we have obtained permission to use the adult scale, although it is not commercially available yet. The Social Responsiveness Scale measures social behaviors such as social awareness, information processing, and social motivation and yields a quantitative score that has been useful in endophenotype studies of Autism Spectrum Disorder. The minimum score that can be obtained is a 0 and the maximum raw score for subscales is 66, maximum total raw score is 153. A lower score represents a positive response.|6 Weeks||||units on a scale||Standard Deviation|Mean
2804541|NCT00490802|Secondary|Yale-Brown Obsessive-Compulsive Scale|The Yale-Brown Obsessive-Compulsive Scale is a clinician-rated questionnaire measuring the time spent, distress, interference, resistance, and control in relation to obsessions and compulsions based on a 5-point scale. This scale has excellent reliability and validity and is used as the gold standard to measure treatment challenges in all Obsessive-Compulsive Disorder clinical trials. The Yale-Brown Obsessive-Compulsive Scale Compulsion Subscale has been shown to be a reliable and valid scale in Autism Spectrum Disorder, and in measuring change in treatment studies of autism. The minimum score that can be obtained is 0 and the maximum score is 20. A lower score represents a positive response.|6 Weeks||||units on a scale||Standard Deviation|Mean
2804542|NCT00490802|Primary|Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test|The Diagnostic Analysis of Nonverbal Accuracy is a measure of emotion recognition across multiple modalities. It consists of five subtests: the Adult Facial Expression Test, the Child Facial Expression Test, the Adult Paralanguage Test, the Child Paralanguage Test, and the Adult Posture Test. The Diagnostic Analysis of Nonverbal Accuracy has established reliability and validity for children as young as 3 and adults as old as 100. The subtests of the test vary on four basic core emotions: happiness, sadness, anger, and fear, and the test provides measures of both high intensity and low intensity emotional reactions. We utilized both the Child Paralanguage and Adult Paralanguage Tests, therefore the minimum score that can be obtained is 0 and the maximum is 48. A higher score represents a positive response.|6 Weeks||||units on a scale||Standard Deviation|Mean
2804543|NCT00490802|Primary|Repetitive Behavior Scale - Revised|"The Repetitive Behavior Scale - Revised was developed to capture the breadth of repetitive behaviors that are specific to autism and is a parent report measure. In particular, it consists of 43-items that tap six repetitive behavior subtypes: Stereotyped, Self-injurious, Compulsive, Ritualistic, Sameness, and Restricted Interests.~Two scores were calculated (higher-order vs. lower-order repetitive behaviors) in an effort to decrease the number of variables analyzed. This is based on previous factor analysis that produced these two factors: higher order (ritualistic, sameness, compulsive and restricted subscales) and lower order (stereotypy and self-injury).~The higher order behaviors have 29 items that can be endorsed with a maximum score of 87 and a minimum score of 0~The lower order behaviors have 14 items that can be endorsed, with a maximum score of 42 and a minimum score of 0~In both cases, a lower score represents a positive response."|6 Weeks||||units on a scale||Standard Deviation|Mean
2804544|NCT00490802|Primary|Clinical Global Impressions Scale - Improvement - Social|"The Clinical Global Impressions Scale - Improvement - Social is a well validated measure employing a 7-point scale of clinical global impression of improvement ( 1- very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse) that the clinician fills out after considering all the available information on the participant including the parent history, the examination in clinic, reports from the school and other sources. Therefore the score is filtered through the judgment of the clinician evaluator.~The Week 6 Improvement Ratings were used to categorize patients as clinically improved (≤2) or not (>2). Sixteen of the 19 patients (84%) had data at Week 6. For the remaining three subjects, Week 6 ratings were imputed using expectation-maximization methods and the earlier Clinical Global Impression ratings. In all three cases the imputed ratings were >2 and the patients were classified as not improved."|6 Weeks||||participants|||Number
2804716|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804545|NCT00490724|Secondary|Urinary Volume|The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed.|Baseline, 3 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millliter||Standard Deviation|Mean
2804546|NCT00490724|Secondary|Assessment of Dyspnea Using Respiratory Rate|Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute|Baseline, 1, 2, 3, 6, 9, 15 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
2804547|NCT00490724|Secondary|Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2)|Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA)|Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here,n=the participants evaluated for this measure at a particular time point.|||Percentage of SpO2||Standard Deviation|Mean
2804548|NCT00490724|Secondary|Number of Participants With Oxygen Therapy|Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy.|Baseline,1 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||Participants|||Number
2804549|NCT00490724|Secondary|Number of Participants With Orthopnea|Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms|Baseline, 1 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.|||Participants|||Number
2804550|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score|Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse|3, 6 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.|||Participants|||Number
2804551|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score|Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, 1 h and 24 h|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.|||Participants|||Number
2804552|NCT00490724|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80*[MPAP−PCWP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||dyne*second/centimeter^5||Standard Deviation|Mean
2804553|NCT00490724|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80*[MBP−MRAP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||dyne*second per centimeter^5||Standard Deviation|Mean
2804554|NCT00490724|Secondary|Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||milliliter per meter^2||Standard Deviation|Mean
2804555|NCT00490724|Secondary|Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||milliliter (ml)||Standard Deviation|Mean
2804556|NCT00490724|Secondary|Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Liter per minute per meter^2 (l/min/m^2)||Standard Deviation|Mean
2804557|NCT00490724|Secondary|Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33*[SBP−DBP])|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
2804558|NCT00490724|Secondary|Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Liter per minute||Standard Deviation|Mean
2804559|NCT00490724|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
2804560|NCT00490724|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
2804561|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
2804562|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
2804563|NCT00490724|Secondary|Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.|||Millimeters of mercury||Standard Deviation|Mean
2804589|NCT00490568|Secondary|Number Participants With Serious Adverse Events (SAEs) and Deaths|A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.|Up to 76 Weeks|All subject (Full population)|||Participants|||Count of Participants
2804564|NCT00490724|Primary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours|Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline and 3 Hours|The per protocol set (PPS) included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2804565|NCT00490698|Primary|Median Time to First Skeletal-related Event|Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.|Up to 1 year|Four participants did not experience skeletal events.|||months||95% Confidence Interval|Median
2804566|NCT00490646|Primary|Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|BOR was the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Refer to Outcome Measure 3 for definition of PD.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks).|All randomized participants.|||participants|||Number
2804567|NCT00490646|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.|||participants|||Number
2804568|NCT00490646|Secondary|Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grade (GR)1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.|||participants|||Number
2804569|NCT00490646|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3=Severe; and Grade 4=Life-threatening or disabling. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy.|||participants|||Number
2804570|NCT00490646|Secondary|Duration of Response|"Period measured in months from time that measurement criteria were first met for CR or PR until first date of documented PD or death from any cause without prior documentation of progression.~PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. Refer to Outcome Measure 1 for definitions of CR and PR. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by Brookmeyer and Crowley method."|From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.)|All randomized participants with CR or PR. The participants who neither relapsed nor died were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
2804571|NCT00490646|Secondary|Time to Response|"Time to response was defined as the time in weeks from randomization until the measurement criteria are first met for a CR or PR, whichever is recorded first.~CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.)|All randomized participants with CR or PR.|||weeks||Full Range|Median
2804605|NCT00490477|Secondary|The Reduction of the Number of Apoptotic Cells, Stimulated With Plasma Derives From Septic Patients With Gram Negative Infection, Treated With PMX-B Hemoperfusion, on Immortalized Tubular and Glomerular Cell Cultures.||72 hours after randomization||2007-04-30|04/2007||||
2804606|NCT00490477|Primary|Number of Participants Not Requiring Renal Replacement Therapy (RRT)||28 days from the admission||||participants|||Number
2804572|NCT00490646|Secondary|Progression Free Survival (PFS)|"Time in months from randomization until first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.~Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months).|All randomized participants. Participants who did not progress or died were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
2804573|NCT00490646|Primary|Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)|Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2804574|NCT00490568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.|12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Score on scale||Standard Deviation|Mean
2804575|NCT00490568|Secondary|Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.|DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) * 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
2804576|NCT00490568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.|The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
2804577|NCT00490568|Secondary|Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.|The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject population. Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
2804578|NCT00490568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.|Baseline (Week 0) and Week 24, 52|All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negative, positive, homozygotes, heterozygotes).|||Scores on scale||Standard Deviation|Mean
2804579|NCT00490568|Secondary|Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT|The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.|Up to Week 82 (including follow up)|All subject population (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2804580|NCT00490568|Secondary|Number of Participants With Hematology Parameters of PCC ATOT|The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.|Up to Week 82 (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2804581|NCT00490568|Secondary|Number of Participants With BW Values of PCC ATOT|The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB >=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB >=7 percent. The number of participants with values of PCC including follow up were reported.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2804582|NCT00490568|Secondary|Number of Participants With HR Values of PCC ATOT|HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB >=30 and DFB >=30. The number of participants with values of PCC including follow up were reported.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2804583|NCT00490568|Secondary|Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)|The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) >=40, decrease from Baseline (DFB) >= 30 for and for DBP (IFB) >= 30 ,DFB >= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2804584|NCT00490568|Secondary|Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides|The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.|Up to 82 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||millimole per litre (mmol/l)||Standard Deviation|Mean
2804585|NCT00490568|Secondary|Change From Baseline in Vital Sign Body Weight (BW)|BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||kg||Standard Deviation|Mean
2804586|NCT00490568|Secondary|Change From Baseline in Vital Sign Heart Rate (HR)|Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
2804587|NCT00490568|Secondary|Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.|Up to 70 Weeks (including follow up)|All subject (Full population). Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2804588|NCT00490568|Secondary|Number of Participants With Adverse Event of Oedema|Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported.|Up to 76 Weeks|All subject (Full population)|||Participants|||Count of Participants
2804647|NCT00490035|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"The categories are:~<= 25 %~- 25 % to < 25 %~25 % to < 50 %~50 % to < 75 %~75 % to < 100 %~100 %"|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2804590|NCT00490568|Primary|Number of Participants With Any Adverse Events (AEs) and Severity of AEs|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.|Up to 76 Weeks|All Subjects (Full population), comprised of all participants who took at least one dose of open-label study medication.|||Participants|||Count of Participants
2804591|NCT00490555|Secondary|Dehydroepiandrosterone (DHEA)||10 weeks||||ng/mL||Inter-Quartile Range|Median
2804592|NCT00490555|Secondary|Androstenedione (AED)||10 weeks||||ng/mL||Inter-Quartile Range|Median
2804593|NCT00490555|Primary|Dihydrotestosterone (DHT) Concentration||10 weeks||||ng/mL||Inter-Quartile Range|Median
2804594|NCT00490555|Primary|Testosterone Concentration||10 weeks||||ng/mL||Inter-Quartile Range|Median
2804595|NCT00490555|Primary|Prostate-specific Antigen (PSA)|PSA level week 10 end of treatment|10 weeks||||ng/mL||Inter-Quartile Range|Median
2804596|NCT00490542|Primary|The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.|Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.|Baseline to 6 weeks|Power analysis, with beta=0.20 and two-tailed alpha=0.05, was based on pilot studies for the mania registration trials which included mixed episodes and assessed MADRS scores. A projected standard error of the mean difference was assumed to be about twice as much as the mean difference (5-15 points), producing a sample size of about 100.|||Scores on a scale||95% Confidence Interval|Mean
2804597|NCT00490529|Secondary|Detection of Tumor-specific CD4-positve T-cells Before and After Vaccination|Anti-tumor T-cell immune responses were evaluated by an in vitro evocative test on their peripheral blood mononuclear cell (PBMCs) before and after vaccination, as assessed by measurement of intracellular cytokines and/or intracellular perforin/granzyme in CD8+ T-cells, and/or CD137 induction on CD4+ T-cells. PBMCs were co-cultured with CpG-activated autologous MCL tumor cells and evaluated for tumor-specific immune responses as measured by CD137 expression on their T cells. The outcome is reported as the number of participants for whom tumor-specific memory CD4 cells were detected at baseline and after transplant (numbers without dispersion).|Baseline and after vaccination and transplant, approximately 5 years|Only participants for which both baseline and post-transplant assessments were available are included.|||Participants|||Count of Participants
2804598|NCT00490529|Secondary|Detection of Tumor-specific CD8-positve Memory T-cells Before and After Vaccination|Anti-tumor T-cell immune responses were evaluated by an in vitro evocative test on their peripheral blood mononuclear cell (PBMCs) before and after vaccination, as assessed by measurement of intracellular cytokines and/or intracellular perforin/granzyme in CD8+ T-cells, and/or CD137 induction on CD4+ T-cells. PBMCs were co-cultured with CpG-activated autologous MCL tumor cells and evaluated for tumor-specific immune responses as measured by CD137 expression on their T cells. The outcome is reported as the number of participants for whom tumor-specific memory CD8 cells were detected at baseline and after vaccination and transplant (numbers without dispersion).|Baseline and after vaccination and transplant, approximately 5 years|Only participants for which both baseline and post-transplant assessments were available are included.|||Participants|||Count of Participants
2804599|NCT00490529|Secondary|Overall Survival (OS)|Overall survival (OS) rate is reported as number and percentage of participants remaining alive the date of transplant through each year, up to 5 years (reported as a number without dispersion).|After 1, 2, 3, 4, and 5 years|Only participants that received the CpG-MCL Vaccine are included.|||Participants|||Count of Participants
2804600|NCT00490529|Secondary|Time-to-progression (TTP)|Time-to-progression (TTP) is measured from the time of autologous stem cell transplantation (ASCT) until the cancer progresses or relapses. Progression is assessed based on CT imaging per the Cheson Criteria (2008). Progression per the Cheson Criteria is defined as having occurred when the sum of tumor lesion dimensions is ≥ 150% of the baseline value. The outcome is reported as the median with 95% confidence interval, as determined by Kaplan-Meier analysis and log-rank test.|7.7 years||||years||95% Confidence Interval|Median
2804601|NCT00490529|Primary|Freedom From Molecular Residual Disease (MRD) Post-autologous Stem Cell Transplant (ASCT)|Molecular residual disease (MRD) is defined as detection in blood samples by the ClonoSEQ test of the (11;14) (q13;q32) gene translocation. It is considered positive if a tumor-specific VDJ sequence is detected in the peripheral blood cells by Ig-HTS at a frequency of greater or equal to 1 molecule per 10,000 input leukocyte equivalents of DNA within 1 year post-autologous stem cell transplant (ASCT). The outcome will be reported as number and percent of participants that maintain MRD-negative status (ie, 1-year freedom from MRD). This outcome is reported as a number without dispersion.|12 months|Only participants for which molecular residual disease (MRD) disease status assessments were available are included.|||Participants|||Count of Participants
2804602|NCT00490490|Secondary|Time-to-Progression (TTP)||2 years|One subject has not progressed (assessment not possible), and one subject has been lost to follow-up.|||Participants|||Count of Participants
2804603|NCT00490490|Secondary|Overall Response Rate (ORR)|"ORR is assessed as the sum of the overall rates of~CR confirmed by positron emission tomography (PET)~CR not confirmed by PET, and~Partial response (PR) negative for progression by PET"|12 weeks||||percentage of participants|||Number
2804604|NCT00490490|Primary|Complete Response (CR) Rate|"Participants assessed for by the following Complete Response (CR) criteria~CR or Functional CR~No evidence of disease and symptoms~Any macroscopic nodules detected in any organs no longer present.~Any palpable lymph node is normal and greatest diameter is < 1.0 cm.~The enlarged organs decreased in size and not palpable~The bone marrow biopsy and aspirate are negative for disease~Negative for disease by PET-scan (functional CR)~CR Unconfirmed (CRu) criteria~No evidence of disease and symptoms~Any lymph node mass > 1.0 cm^2 diameter has regressed is size by more than 75%.~No macroscopic nodules in any organs~Any palpable lymph node is normal and greatest diameter is < 1.0 cm.~The bone marrow biopsy and aspirate are negative for disease~The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia"|12 weeks||||percentage of participants|||Number
2804607|NCT00490451|Secondary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.|First treatment dose up to 26.51 months|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2804608|NCT00490451|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every other cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented SD or better to first date of progressive disease up to 15.57 months|All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.|||months||90% Confidence Interval|Median
2804609|NCT00490451|Secondary|Duration of Overall Objective Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to progressive disease or death up to 15.57 months|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.||||||
2804610|NCT00490451|Secondary|Overall Survival Time|Defined as the time from date of first dose to the date of death due to any cause.|First treatment dose to death due to any cause up to 26.51 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
2804611|NCT00490451|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)|Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2804612|NCT00490451|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)|Clinical Benefit Rate = (CR + PR + SD)/N as classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0), where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|First treatment dose to measured progressive disease or death due to any cause up to 15.57 months|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2804613|NCT00490451|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|First treatment dose to measured progressive disease or death due to any cause up to 15.57 months|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2804614|NCT00490451|Primary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|First treatment dose to measured progressive disease or death from any cause up to 15.57 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
2804615|NCT00490269|Primary|Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.|Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.|Day 9 and 10||||participants|||Number
2804616|NCT00490256|Primary|iFAB Post-op|intestinal fatty acid binding protein level immediately postop|Immediate postop||||mcg/ml||Standard Deviation|Mean
2804617|NCT00490256|Secondary|Cerebral and Lower Body Near Infra-red Spectroscopy Measures||24 hours|||||||
2804618|NCT00490256|Primary|Intestinal Fatty Acid Binding Protein and C-reactive Protein||Baseline and 0, 3, 12, and 24 hours after surgery|||||||
2804619|NCT00490139|Secondary|DFS Ignoring Non-breast Second Primary Malignancies|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause. DFS was estimated using the Kaplan Meier method. The non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact. Non-breast second primary cancers were ignored.|||years|||Number
2804717|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804620|NCT00490139|Secondary|Time to Central Nervous System Recurrence|Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence. Both brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.|From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.|||years|||Number
2804621|NCT00490139|Secondary|Time to Distant Recurrence|Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence). The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.|From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility.|||years|||Number
2804622|NCT00490139|Secondary|Time to Recurrence|Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant). The percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years. IDMC=Independent Data Monitoring Committee.|From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.|||years|||Number
2804623|NCT00490139|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause. Overall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.|From randomization until death due to any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not die were censored at the date of last survival contact. Zero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).|||years|||Number
2804624|NCT00490139|Primary|Disease-free Survival (DFS)|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause. DFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication. Par. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.|||years|||Number
2804625|NCT00490100|Primary|Change in Growth Rate on Study Drug|Growth rate on intervention is compared with growth rate before intervention for each participant.|During intervention, up to 2 years|Only participants who completed study|||cm/year||Full Range|Median
2804626|NCT00490100|Primary|Safety of Study Drug|Rates of adverse events related to study drug|1 year||||participants|||Number
2804627|NCT00490061|Secondary|Overall Survival.|Overall survival is the time from starting treatment until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.|Two years survival rate after study enrollment|All enrolled participants.|||percentage of participants|||Number
2804628|NCT00490061|Primary|Progression Free Survival|"To determine the efficacy of combining lapatinib and radiotherapy in terms of Progression-free survival (PFS) in patients with locally advanced HNSCC who cannot tolerate concurrent chemoradiotherapy.~Progression-free survival is defined is the time from starting treatment to the time of first documented tumor progression or death due to any cause, which ever occurs first.~Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST V1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|2 year PFS: PFS at 2 yrs after study enrollment|All enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2804629|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804718|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liter||Standard Deviation|Mean
2804630|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804631|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804632|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804633|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804634|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804635|NCT00490035|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|"The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: Assess the Overall change in the severity of patient's illness, compared to start of study medication."|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804636|NCT00490035|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|"The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: Overall, has there been a change in your seizures since the start of the study medication?"|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804648|NCT00490035|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percent change in seizures per week||Inter-Quartile Range|Median
2804637|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.|||units on a scale||Standard Deviation|Mean
2804638|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
2804639|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
2804640|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
2804641|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.|||units on a scale||Standard Deviation|Mean
2804642|NCT00490035|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."|||percentage of participants|||Number
2804643|NCT00490035|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2804644|NCT00490035|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2804645|NCT00490035|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2804646|NCT00490035|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2804696|NCT00489918|Secondary|Absolute Change in Lumbar Spine BMD: Baseline to Week 12|Absolute Change in Lumbar Spine BMD from Baseline to Week 12|12 weeks|ITT/Safety Population|||g/cm^2||Standard Deviation|Mean
2804649|NCT00490035|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Times per week||Inter-Quartile Range|Median
2804650|NCT00490035|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period|"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.~The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline."|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2804651|NCT00490035|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.|||Seizure Frequency per Week||Inter-Quartile Range|Median
2804652|NCT00490022|Secondary|Prostate Epithelial Cell Proliferation|Prostate epithelial cell proliferation in the prostate biopsy tissue was measured using Ki-67 immunohistochemical staining of prostate epithelium as a marker of cell proliferation (values are number of Ki-67 positive stained cells per 100 prostate epithelial cells). The placebo and treatment groups were compared.|28-days||||#pos.Ki-67cells per100 prst. epth cells||Standard Deviation|Mean
2804653|NCT00490022|Primary|Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel.|After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.|28-days||||ng/g||Standard Deviation|Mean
2804654|NCT00490009|Secondary|Overall Survival (OS) Rate|Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.|6 years|1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.|||percentage of participants|||Number
2804655|NCT00490009|Secondary|Time to Progression (TTP)|Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.|1.5 months; 3 months; 6 months; or Not Progressed|1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.|||participants|||Number
2804656|NCT00490009|Primary|Clinical Response Rate|Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.|6 years||||participants|||Number
2804657|NCT00489970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Year 0 to Year 9|The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.|||Participants|||Count of Participants
2804658|NCT00489970|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical oc-currence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.|||Participants|||Count of Participants
2804659|NCT00489970|Secondary|Number of Subjects With Any Large Injection Site Reaction.|Large injection site reaction = a swelling with a diameter > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference.|During the 4-day (Days 0-3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.|||Participants|||Count of Participants
2804660|NCT00489970|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever [defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever > 104.0 degrees F.|During the 4-day (Days 0-3) post vaccination period.|The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.|||Participants|||Count of Participants
2804661|NCT00489970|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were Pain, Redness and Swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = Redness/Swelling with a diameter ≥ 50 mm.|During the 4-day (Days 0-3) post vaccination period.|The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.|||Participants|||Count of Participants
2804697|NCT00489918|Secondary|Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12|Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12|12 weeks|ITT/Safety Population|||Percent change||Standard Deviation|Mean
2804739|NCT00489827|Secondary|Postoperative Renal Function|maximum p-creatinine value recorded postoperatively < 30 days|30 days||||µmol/L||Standard Deviation|Mean
2804662|NCT00489970|Secondary|Seroprotection Status for Anti-D Antibody Concentration|Seroprotection status for anti-D antibody concentration < 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody.|At Year 9, one month before and after the booster vaccination|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Percentage of subjects|||Number
2804663|NCT00489970|Secondary|Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens|Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and < 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative|At Year 9, one month after booster vaccination|Analysis was performed on the adapted According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804664|NCT00489970|Secondary|Alternative Booster Response to Anti-D and Anti-T Antigens|Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and <1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and <6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration < 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative|At Year 9, one month after booster vaccination|Analysis was performed on the adapted According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804665|NCT00489970|Secondary|Anti-PRN Antibody Concentration|Anti-PRN antibody concentration is expressed as GMC in IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2804666|NCT00489970|Secondary|Anti-PRN Antibody Concentration|Anti-PRN antibody concentration is expressed as GMC in IU/mL|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
2804667|NCT00489970|Secondary|Anti-FHA Antibody Concentration|Anti-FHA antibody concentration was expressed as GMC in IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2804668|NCT00489970|Secondary|Anti-FHA Antibody Concentration|Anti-FHA antibody concentration is expressed as GMC in IU/mL|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
2804669|NCT00489970|Secondary|Anti-PT Antibody Concentration|Anti-PT antibody concentration was expressed as GMC in IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2804670|NCT00489970|Secondary|Anti-PT Antibody Concentration|Anti-PT antibody concentration is expressed as GMC in EL.U/mL.|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
2804671|NCT00489970|Secondary|Anti-T Antibody Concentration|Anti-T antibody concentration is expressed as GMC in IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the adapted According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||IU/mL||95% Confidence Interval|Geometric Mean
2815734|NCT00413153|Secondary|Lipid Metabolism - Serum Triglyceride|6 month mean and standard deviation for serum triglyceride.|6 months|Repeated measures analysis using all available data points for each participant|||mg/dL||Standard Deviation|Mean
2804672|NCT00489970|Secondary|Anti-T Antibody Concentration|Anti-T antibody concentration is expressed as GMC in IU/mL.|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
2804673|NCT00489970|Secondary|Anti-D Antibody Concentration|Anti-D antibody concentration is expressed as GMC in IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the adapted According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||IU/mL||95% Confidence Interval|Geometric Mean
2804674|NCT00489970|Secondary|Anti-D Antibody Concentration|Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||IU/mL||95% Confidence Interval|Geometric Mean
2804675|NCT00489970|Secondary|Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Participants|||Count of Participants
2804676|NCT00489970|Secondary|Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||Participants|||Count of Participants
2804677|NCT00489970|Secondary|Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Participants|||Count of Participants
2804678|NCT00489970|Secondary|Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804679|NCT00489970|Secondary|Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL.|At Year 9, one month before and after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Participants|||Count of Participants
2804680|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL).|At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||Participants|||Count of Participants
2804681|NCT00489970|Primary|Booster Response to PT, FHA and PRN Antigens|Booster response was defined as: for subjects with pre-vaccination antibody concentration < 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL (S+, <4*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative|At Year 9, one month after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Participants|||Count of Participants
2804682|NCT00489970|Primary|Booster Response to D and T Antigens|A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: < 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.|At Year 9, one month after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Participants|||Count of Participants
2804683|NCT00489970|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|For anti-PT, anti-FHA and anti-PRN antibody response and for Boostrix and Adacel Groups, the two sided 97.5 % CIs of the GMC ratios between subjects in the Boostrix Group and (divided by) the Infanrix Group in APV-039 one month after vaccination (one month after vaccination for Boostrix Group, one month after the third dose of Infanrix for Infanrix Group in APV-039) was computed.|One month after the third dose of Infanrix in Study APV-039|Analysis was performed on the Total Vaccinated Cohort (TVC) at Year 9 which included all subjects with a study vaccine administration dose documented: a safety analysis based on the TVC included all vaccinated subjects, an immunogenicity analysis based on the TVC included all vaccinated subjects for whom immunogenicity results were available.|||Concentration Ratio||97.5% Confidence Interval|Geometric Mean
2804684|NCT00489970|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.|At Year 9, one month after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2804685|NCT00489970|Primary|Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL|Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated|At Year 9, one month after the booster vaccination.|Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.|||Participants|||Count of Participants
2804686|NCT00489970|Primary|Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.|At Year 9, one month before the booster vaccination.|Analysis was performed on the adapted According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804687|NCT00489970|Primary|Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.|At year 5 after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||Participants|||Count of Participants
2804688|NCT00489970|Primary|Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.|At year 3 after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 3 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804689|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.|At year 1 after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint|||Participants|||Count of Participants
2804690|NCT00489970|Primary|Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA.|At Year 9, one month before the booster vaccination.|Analysis was performed on the adapted According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804691|NCT00489970|Primary|Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA.|At year 5 after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804692|NCT00489970|Primary|Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off|Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA|At year 3 after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 3 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804693|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off|Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)|At year 1 after the vaccination in primary study (NCT00346073)|Analysis was performed on the According-to-Protocol (ATP) Year 1 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.|||Participants|||Count of Participants
2804694|NCT00489918|Secondary|Percent Change in Femoral Neck BMD: Baseline to Week 24|Percent Change in Femoral Neck BMD from Baseline to Week 24|24 Weeks|ITT/Safety Population|||Percent change||Standard Deviation|Mean
2804695|NCT00489918|Secondary|Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24|Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24|24 Weeks|ITT/Safety Population|||Percent change||Standard Deviation|Mean
2804699|NCT00489866|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.|||Units on a Scale||Standard Deviation|Mean
2804700|NCT00489866|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.|||Units on a scale||Standard Deviation|Mean
2804701|NCT00489866|Primary|Positive and Negative Symptoms Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.|||Units on a Scale||Standard Deviation|Mean
2804702|NCT00489866|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).|Week 2 and Week 6||||Units on a Scale||Standard Deviation|Mean
2804703|NCT00489866|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2 and Week 6|Analysis was intention to treat.|||Units on a scale||Standard Deviation|Mean
2804704|NCT00489853|Secondary|SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score|Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.|Single measurement taken at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
2804705|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Kilopascals||Standard Deviation|Mean
2804706|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804707|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804708|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804709|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804710|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804711|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||kilopascal||Standard Deviation|Mean
2804712|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liter||Standard Deviation|Mean
2804713|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2804714|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Median
2804715|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period||||Liters||Standard Deviation|Mean
2815735|NCT00413153|Secondary|Fasting Glucose|6 month mean and standard deviation for fasting glucose.|6 months|Repeated measures analysis using all available data points for each participant|||mg/dL||Standard Deviation|Mean
2804719|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included.|Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
2804720|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
2804721|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
2804722|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).|Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
2804723|NCT00489853|Secondary|Number of Inhalations of Reliever Medication|The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Number of inhalations during 24 hours||Standard Deviation|Mean
2804724|NCT00489853|Secondary|Cough Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Scores on a scale||Standard Deviation|Mean
2804725|NCT00489853|Secondary|Chest Tightness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Score on a scale||Standard Deviation|Mean
2804726|NCT00489853|Secondary|Breathlessness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Score on Scale||Standard Deviation|Mean
2804727|NCT00489853|Secondary|Sleep Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Score on Scale||Standard Deviation|Mean
2804728|NCT00489853|Secondary|Peak Expiratory Flow (PEF) Before Morning Dose|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period||||Liters/minute||Standard Deviation|Mean
2804729|NCT00489853|Secondary|Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment||||Liters||Standard Deviation|Mean
2804730|NCT00489853|Secondary|Forced Vital Capacity (FVC) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment||||Liters||Standard Deviation|Mean
2804731|NCT00489853|Secondary|Forced Expiratory Flow (FEV1) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment||||Liters||Standard Deviation|Mean
2804732|NCT00489853|Secondary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken 6 hours post-dose at the end of each 1-week treatment period||||Seconds||Standard Deviation|Mean
2804733|NCT00489853|Primary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken1 hour post-dose at the end of each 1-week treatment period||||Seconds||Standard Deviation|Mean
2804734|NCT00489827|Secondary|Long-term Survival|Late mortality - related to biochemical markers (troponin-T, mixed venous oxygen saturation, NT-proBNP) and intervention|6 months - 10 years||2020-09-30|09/2020||||
2804735|NCT00489827|Secondary|Severe Circulatory Failure in CCS Class IV Patients|Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients|30 days|CCS class IV patients|||Participants|||Count of Participants
2804736|NCT00489827|Secondary|Atrial Fibrillation|Number of patients with atrial fibrillation recorded postoperatively|Hospital stay||||Participants|||Count of Participants
2804737|NCT00489827|Secondary|ICU Stay|ICU duration of stay (hours)|ICU stay||||hours||Inter-Quartile Range|Median
2804738|NCT00489827|Secondary|Neurological Safety|Incidence of Postoperative stroke < 24 hours (CT-scan)|24 hours||||Participants|||Count of Participants
2804740|NCT00489827|Secondary|Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40)|Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40)|End of surgery|Moderately or severely reduced LVEF (<0.40)|||Participants|||Count of Participants
2804741|NCT00489827|Secondary|Postoperative Hemodynamic State|Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU|Until arrival to ICU||||percentage of saturated hemoglobin||Standard Deviation|Mean
2804742|NCT00489827|Secondary|Degree of Perioperative Myocardial Injury|p-CK-MB postoperative day 1, p-troponin-T postoperative day 3|perioperative||||µg/L||Inter-Quartile Range|Median
2804743|NCT00489827|Primary|Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality||30 days||||Participants|||Count of Participants
2804744|NCT00489736|Other Pre-specified|Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting|"The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.|||participants|||Number
2804745|NCT00489736|Secondary|Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event|"The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.|||participants|||Number
2804746|NCT00489736|Primary|Treatment Failure|"The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the efficacy analysis according to the treatment received.|||participants|||Number
2804747|NCT00489554|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 5|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2804748|NCT00489554|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2804749|NCT00489554|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature > 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2804750|NCT00489554|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
2804751|NCT00489554|Secondary|Number of Subjects Seropositive for Anti-Protein D Antibodies|Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
2804752|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
2804753|NCT00489554|Secondary|Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
2804754|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
2804755|NCT00489554|Secondary|Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
2804756|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2804757|NCT00489554|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
2804758|NCT00489554|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter|The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||subjects|||Number
2804759|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2804760|NCT00489554|Primary|Antibody Concentrations Against Protein D|Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
2804761|NCT00489554|Primary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes|Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
2804762|NCT00489541|Secondary|Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the patients who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|Intent-to-Treat. All enrolled patients are included in the analysis.|||participants|||Number
2804763|NCT00489541|Primary|In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)|Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.|9 months post-index procedure|The primary analysis population for the superiority testing of the primary endpoint, 9-month in-stent late loss, is the intent-to-treat (ITT) population, i.e. all patients who had a study device implanted at the target lesion and completed their angiographic follow-up.|||millimeter||Standard Deviation|Mean
2804764|NCT00489489|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.|||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
2804765|NCT00489489|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-β dose level as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||relapses per year||95% Confidence Interval|Number
2807179|NCT00470535|Secondary|Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
2804766|NCT00489489|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN;"|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2804767|NCT00489489|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters per scan|||Number
2804768|NCT00489489|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||lesions per scan||95% Confidence Interval|Number
2804769|NCT00489489|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume of all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters||Standard Error|Least Squares Mean
2804770|NCT00489489|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly Hair loss and Hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2804771|NCT00489489|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2804772|NCT00489476|Other Pre-specified|Responders, Sustained Freedom From Pain|The percentages of patients with sustained freedom from pain (pain-free at 2 hours after dosing with no rescue medication and no recurrence of headache from 2 to 24 hours)|Baseline through 24 h post-dose|ITT with LOCF Population|||Participants|||Count of Participants
2804773|NCT00489476|Secondary|Pain-free at 2 Hours|Pain-free (Pain-IHS) at the 2 hour time point|Baseline and 2 h post-dose|ITT with LOCF Population|||Participants|||Count of Participants
2804774|NCT00489476|Primary|Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours|"The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD.~Intent to treat (ITT) with last observation carried forward (LOCF)"|Baseline and 2 h post-dose|ITT Population with LOCF|||participants|||Number
2804775|NCT00489424|Secondary|Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity|Effect on severity of symptoms following i.v. infusion of zoledronic acid 5 mg. The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms). The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.|0 - 3 days|Intent to Treat (ITT) population. Number of participants analyzed may vary from ITT population due to some patients not reporting baseline or post baseline VAS measurement. Calculating change requires both baseline and post baseline values to be present.|||units on a scale||Standard Deviation|Mean
2804776|NCT00489424|Secondary|Proportion of Patients Reporting Severe Questionnaire Symptoms.|A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
2804777|NCT00489424|Secondary|Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.|A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v. infusion of zoledronic acid 5 mg. The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
2804778|NCT00489424|Secondary|Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. Two patients who took rescue medication in fluvastatin arm were not included in analysis since the time rescue medication was taken was not recorded.|||hours||Standard Deviation|Mean
2804779|NCT00489424|Secondary|Number of Rescue Medication Tablets Taken|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. One patient in acetaminophen arm was not included in analysis since the number of tablets taken was not recorded.|||tablets||Standard Deviation|Mean
2804780|NCT00489424|Secondary|Proportion of Patients Who Used Rescue Medication.|Patients that took rescue medication >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Intent to Treat (ITT) population. One patient who used rescue medication in acetaminophen arm and two patients in fluvastatin arm were not included in analysis due to lack of documentation regarding use and exposure of rescue medication.|||proportion of patients|||Number
2804781|NCT00489424|Secondary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.|Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
2804782|NCT00489424|Primary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.|Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.|||proportion of patients|||Number
2804783|NCT00489411|Secondary|Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item|Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period.|Day 1 of Week 8 to Day 1 of Week 13|Patients who completed crossover intervention and had complete data were included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2804784|NCT00489411|Secondary|Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5|Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.|Day 1 of Week 1 to Day 1 of Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.|||units on a scale||95% Confidence Interval|Mean
2804785|NCT00489411|Secondary|Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score|Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.|Day 1 of Week 1 to Day 1 to Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.|||units on a scale||95% Confidence Interval|Mean
2804786|NCT00489411|Primary|Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item|Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.|Day 1 of Week 1 to Day 1 of Week 6|Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.|||units on a scale||95% Confidence Interval|Mean
2804787|NCT00489359|Secondary|Phase 2 - Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
2804788|NCT00489359|Secondary|Phase 2 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline through end of Phase 2 (up to 31 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||participants|||Number
2804789|NCT00489359|Secondary|Phase 2 - Overall Survival|Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.|baseline to date of death from any cause (up to 31 months)|Protocol Qualified (PQ) population. This analysis was not done due to the high number of censored patients.|||months||95% Confidence Interval|Median
2804790|NCT00489359|Secondary|Phase 2 - Time to Treatment Failure|Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.|First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
2804791|NCT00489359|Secondary|Phase 2 - Time to Disease Progression|Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined using RECIST."|||Months||95% Confidence Interval|Median
2804792|NCT00489359|Secondary|Phase 2 - Duration of Response (DOR)|Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.|time of response to progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
2804793|NCT00489359|Secondary|Phase 2 - Time to Response (TTR)|Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|First treatment to response (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||Months||95% Confidence Interval|Median
2804794|NCT00489359|Secondary|Phase 1 - Number of Participants With Tumor Response|Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||Participants|||Number
2804795|NCT00489359|Secondary|Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||mg/mL*min|||Number
2817506|NCT00400829|Secondary|Progression Free Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to the time of documented progression, assessed up to 5 years||||Months||95% Confidence Interval|Median
2804796|NCT00489359|Secondary|Phase 1 - Recommended Dose of Pemetrexed for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||mg/m^2 (milligrams per square meter)|||Number
2804797|NCT00489359|Secondary|Phase 1 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||Participants|||Number
2804798|NCT00489359|Secondary|Phase 1 - Number of Dose-Limiting Toxicities (DLTs)|"The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L).~Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment).~Treatment delay more than 1 week due to toxicity."|baseline through end of Phase 1 (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).|||DLT events|||Number
2804799|NCT00489359|Primary|Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)|"Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions.~Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100"|baseline to measured progressive disease (PD) (up to 18 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."|||percentage of participants||95% Confidence Interval|Number
2804800|NCT00489359|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin|MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.|First treatment to toxicity (up to 18 months)|MTD was not determined in this study, so zero participants were analyzed.|||mg/m^2|||Number
2804801|NCT00489281|Secondary|Donor Chimerism at 1 Year|Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells.|1 year||||Participants|||Count of Participants
2804802|NCT00489281|Secondary|Donor Chimerism at 30 Days|Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells.|30 days||||Participants|||Count of Participants
2804803|NCT00489281|Primary|Progression-free Survival|Percentage of participants who are alive without relapse.|2 years|Due to early study termination, data was not collected to assess this outcome measure||||||
2804804|NCT00489281|Primary|Transplant-related Mortality|Number of participants who died for reasons related to bone marrow transplant.|Up to one year||||Participants|||Count of Participants
2804805|NCT00489268|Secondary|Percentage of Participants With Sub-squamous Intestinal Metaplasia|The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.|5 year|The analysis was done per protocol.|||Percent of Participants|||Number
2804806|NCT00489268|Secondary|Adverse Events|The secondary outcome adverse events was defined as any event that occurred during the course of the trial|5 year|The analysis was done per protocol.|||Participants|||Number
2804807|NCT00489268|Secondary|Progression of Histological Grade|Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.|5 year|The analysis was done per protocol.|||Percent of Participants|||Number
2804808|NCT00489268|Primary|Percentage of Participants With Histological Clearance of Barrett's Metaplasia|The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM). CR-IM means complete eradication of IM (diseased epithelium). A patient was considered a Complete Responder (CR) if all biopsies (100%) were negative for intestinal metaplasia (CR-IM).|5 year|The analysis was done per protocol.|||Percent of Participants|||Number
2804809|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804918|NCT00488488|Primary|Percentage of Participants With Composite Cure: All Participants|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants.|||percentage of participants|||Number
2804810|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804811|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804812|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804813|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804814|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804815|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804816|NCT00489255|Secondary|Median Time to 'on' for Visit 5/End of Period 3 Injection|"Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection."|Day 84 (Visit 5)||||minutes||95% Confidence Interval|Median
2804817|NCT00489255|Secondary|Median Time to 'on' for Visit 4/End of Period 2 Injection|"Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection."|Day 56 (Visit 4)||||minutes||95% Confidence Interval|Median
2804818|NCT00489255|Secondary|Median Time to 'on' for Visit 3/End of Period 1 Injection|"Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection."|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Median
2804819|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 2|"Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection."|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Median
2804820|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 1|"Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection."|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Median
2804821|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 3|"The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor."|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.|||participants|||Number
2804822|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 2|"The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor."|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.|||participants|||Number
2804823|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 1|"The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor."|Day 28 (Visit 3)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.|||participants|||Number
2804824|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3|The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804825|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2|The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804826|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1|The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 1-28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2804827|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 3||Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
2804828|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 2||Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
2804829|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 1||Days 1-28|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
2804830|NCT00489255|Primary|Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1||Day 1 (Period 1, Visit 2)|Primary efficacy analyses performed on the Intention-to-Treat (ITT) population.|||participants|||Number
2804831|NCT00489216|Secondary|Overall Hepatic Response Rate|The normalization of the total serum bilirubin to <2mg/dL|On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab|There is no data for this outcome measure as no enrolled patients had an elevated bilirubin level.||||||
2804832|NCT00489216|Secondary|Complete Cutaneous Response Rate|The complete disappearance of all signs of cutaneous graft-versus-host disease. Complete cutaneous response rate + partial cutaneous response rate|On study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab||||participants|||Number
2804833|NCT00489216|Secondary|Overall Complete Response Rate|To assess the overall complete response rate on study days 29 and 57 after 4 and 8 doses of weekly subcutaneous efalizumab. A complete response (CR) was defined as the total resolution of skin disease, and a partial response was defined as >=50% reduction in the proportion of total body surface area involved by rash.|57 days|Of the two patients, one patient completed all 8 doses of study medication according to schedule. The other patient received 6/8 scheduled efalizumab doses, but was subsequently taken off the study after developing transient coagulase negative staphylococcal bacteremia. The patient demonstrated a complete response (CR).|||Participants|||Count of Participants
2804834|NCT00489216|Primary|Exploratory Assessment of the Staining of Cutaneous Tissues for LFA-1, ICAM-1, CD4, CD8, and Possibly CD20|Numerical scoring system for both LFA-1 and ICAM-1 expression which could then be used in a larger phase II trial to correlate clinical response rates to pathological findings.|57 days|There is no data for this outcome measure because of the small number of patients and inability to make meaningful conclusions||||||
2804835|NCT00489216|Primary|Degree of Skin Involvement by GVHD Using Two Digital Photography Techniques.|"Estimate of the percentage of body surface area involved by GVHD using two digital photography techniques and computerized image analyses:~Digital photography and body surface area calculations: A total of 12 digital photographs were obtained from different body regions using systematic digital imaging and computerized image analysis.~Body surface area calculations: Using National Institutes of Health image software, each body region will be manually traced and the total area of the traced area determined. Using a similar technique, each part of the region that is involved by a GVHD rash will also be traced and its area measured. The areas involved by rash will then be summed, and finally divided by the total area of the region. In so doing, the percentage of each region that is involved by GVHD will be determined."|120 days|Data was not collected for this objective due to limited number of participants. A minimum of 12 patients were needed for analysis.||||||
2804836|NCT00489216|Primary|Number of Subjects Experiencing Adverse Events|"The primary objective of this exploratory study is to evaluate the general tolerability of efalizumab in patients suffering from steroid refractory GVHD~Subjects will be evaluated for drug toxicity each visit. Toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) common criteria."|120 days|Of the two patients, one patient completed all 8 doses of study medication according to schedule. The other patient received 6/8 scheduled efalizumab doses, but was subsequently taken off the study after developing transient coagulase negative staphylococcal bacteremia.|||participants|||Number
2804837|NCT00489086|Secondary|Overall Response at Treated Lesions||36 months|||||||
2804838|NCT00489086|Secondary|Estimated Duration of Complete Response||36 months|||||||
2804839|NCT00489086|Secondary|Time to Progression||36 months|||||||
2804840|NCT00489086|Secondary|Time to Lesion Clearance||36 months|||||||
2804841|NCT00489086|Primary|Complete Response Rate|"The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's target lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less."|36 months|Intention to treat|||participants|||Number
2804842|NCT00488982|Secondary|Cumulative Duration of Time on and Off Docetaxel-based Therapy|Median percentage of time will be calculated to summarize the total duration of chemotherapy and amount of docetaxel/prednisone administered while the patient is on study. The same results will be tabulated for each. For the on-chemotherapy period: will be estimated from the date of starting protocol therapy; if a patient received docetaxel on day 2 of a cycle, he will be considered to have received a full 21 days on therapy. For the off-chemotherapy period: will be calculated from the date of starting the observation or GM-CSF period to the date of resuming chemotherapy|Up to 7 years||||months||95% Confidence Interval|Median
2804843|NCT00488982|Secondary|Number of Participants With PSA Response to Successive Series of Chemotherapy|PSA partial response is defined by at least a 50% decline from PSA value from the baseline measurement to 12 weeks of protocol therapy. The decline must be confirmed by a second PSA value obtained 4 or more weeks later For those patients whose PSA have decreased but has not reached response criteria defined above, progressive disease is defined as 25% increase over the nadir PSA value provided that the increase is at least 5ng/mL and is confirmed.|Up to 6 years|Twenty-six participants total resumed a second course of the Docetaxel, and five participants went on to resume a third course of treatment.|||Participants|||Count of Participants
2804844|NCT00488982|Secondary|Overall Survival|The Kaplan-Meier product limit method will be used to estimate the median overall survival|Up to 7 years||||months||95% Confidence Interval|Median
2804845|NCT00488982|Primary|Time to Progression|The Kaplan-Meier product limit method with 95% confidence intervals will be used to estimate the median time to disease progression during initial course of randomized treatment|Up to 7 years||||months||95% Confidence Interval|Median
2804846|NCT00488865|Primary|Percentage of Participants With Retrieval Clinical Success|Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.|upto 175 days|The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients.|||Percent of Participants||95% Confidence Interval|Number
2804847|NCT00488865|Secondary|Placement Technical Success|Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.|Immediately post placement procedure||||Percent of Participants||95% Confidence Interval|Number
2804848|NCT00488865|Primary|Percentage of Participants With Clinical Success|Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.|up to 180 days|The number of participants was determined per intention to treat (ITT).|||Percent of Participants||95% Confidence Interval|Number
2804849|NCT00488826|Secondary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"The population analyzed was all the available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post third dose serum available for assessment) and were in either 7vPnC+DTaP Concurrently or DTaP Alone group. The 7vPnC Separately group was not included as part of this objective."|||ug/ml||95% Confidence Interval|Geometric Mean
2804850|NCT00488826|Primary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"Population analyzed was available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post-third dose serum available for assessment) and were in either the 7vPnC separately or DTaP alone group. The 7vPnC + DTaP group was not part of the primary objective; no statistical testing was done."|||ug/ml||95% Confidence Interval|Geometric Mean
2804851|NCT00488774|Secondary|Number of Participants With Clinical Remission|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.|||Participants|||Number
2804852|NCT00488774|Primary|Number of Participants With Clinical Response|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.|||Participants|||Number
2804853|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric mean concentration was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.|||µg/mL||95% Confidence Interval|Geometric Mean
2804854|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.|||µg/mL||95% Confidence Interval|Mean
2804855|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age.|7 days post 12 months vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).|||Percentage of subjects|||Number
2804856|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age.|7 days post 12 month vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).|||Percentage of subjects|||Number
2804857|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months).|7 days post vaccination at 2, 3, and 4 months of age|The analysis was performed on the safety population.|||Percentage of subjects|||Number
2804858|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination.|7 days post each MenACWY-CRM and routine infant vaccination|The analysis was performed on the Safety Population.|||Percentage of subjects|||Number
2804859|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months|"The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers.~Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model."|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset after booster vaccination.||||||Number
2804860|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM|Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model.|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset of persistence population.||||||Number
2804861|NCT00488683|Secondary|Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants|The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA.|Day 1 (IgG) and one month after primary vaccination (B cells)|Analysis was performed on the PP primary population.||||||Number
2804862|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific hSBA titers, the geometric mean titer was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.|||titers||95% Confidence Interval|Geometric Mean
2804863|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination|"To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells, plasma B cells and IgG concentrations were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.~The memory B cell response at different timepoint was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators in vitro.~The B plasma cell response at each time point was defined as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC."|Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.|||per 2x100000 cells||Standard Deviation|Mean
2804864|NCT00488683|Secondary|Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination|The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC.|One month after primary vaccination|Analysis was performed on the PP primary population and PP persistence population, subjects lacking hSBA ≥1:8 one month after primary vaccination.|||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
2804865|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.|||titers||95% Confidence Interval|Mean
2804866|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x100000 LOC.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.|||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
2804867|NCT00488683|Secondary|CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination|"CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC.~CRM197 specific IgG concentration was measured by ELISA at 12 months of age and one month after MenACWY-CRM booster vaccination."|5 months (B cells), 12 months and 13 months (B cells and IgG) of age|Analysis was done on the PP primary population and PP booster population.||||||Number
2804868|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and at 1 week after third vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC.~Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and hSBA GMTs were measured at 1 week after third vaccination."|One month after primary vaccination and 1 week after third vaccination|This outcome was assessed in Group 3 subjects only as they provided a blood draw at 1 week following the MenACWY-CRM booster vaccination. Analysis was performed on PP booster population.||||||Number
2804869|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and third (booster) vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA.~hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination.~The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x)at 12 months where x is the serogroup specific IgG or memory B cell concentrations or SBA titers."|1 month after primary and pre-third and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.~Analysis was performed on PP booster population."||||||Number
2804870|NCT00488683|Secondary|Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~hSBA GMTs for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination.~The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA."|1 month after primary vaccination and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.~Analysis was performed on PP booster population."||||||Number
2804871|NCT00488683|Secondary|Memory B Cells by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA."|1 month after primary vaccination and immediately before third dose|Analysis was performed on PP dataset of persistence population.||||||Number
2804872|NCT00488683|Primary|Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y|"The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators.~Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose).~Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y."|1 month after primary vaccination and immediately before third dose at 12 months of age|Analysis was performed on per-protocol (PP) dataset of primary vaccination, i.e. subjects who received all the relevant doses of vaccine correctly; provided evaluable blood samples at the relevant time points; and had no major protocol violation as defined prior to analysis.|||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
2804890|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
2804873|NCT00488644|Primary|Number of Participants Demonstrating Improvement With Impaired Neuro-cognitive Function (NCF) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and 8 Weeks After Liothyronine Therapy|At baseline, each participant's scores for standardized/widely-used NCF exams are recorded (recalled words/objects/sequence repetition/etc per tests listed below). After 8 weeks liothyronine therapy, participants are tested again and scores compared to baseline scores. If the participant recalls more numbers/objects/sequence repetition faster/etc., than previous scores, this constitutes an improvement in NCF function for that individual. Scores are not compared to other participants. NCF tests: Memory by RAVLT (Rey Auditory Verbal Learning Test), scored by the number of words correctly recalled at different timepoints; Attention by Digit Span Exam (accurately repeating a sequence of numbers just spoken); Processing speed by Digit Symbol Exam (accurately matching numbers with associated symbols) Executive function by Trail Making Tests and Controlled Oral Word Association; Motor dexterity evaluated by correctly placing pegs in pegboards in a specified time.|At baseline and after 8 weeks of treatment||||participants|||Number
2804874|NCT00488631|Secondary|Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 54|Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2804875|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2804876|NCT00488631|Secondary|Number of Participants With Mucosal Healing at Both Week 30 and Week 54|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2804877|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and Week 54|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2804878|NCT00488631|Primary|Number of Participants in Clinical Response Through Week 54|Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.|Induction Baseline, Week 0 through Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2804879|NCT00488618|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate.|Baseline, 3 Weeks|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, LOCF.|||score on a scale||Standard Error|Least Squares Mean
2804889|NCT00488514|Secondary|Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month|The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||events||Standard Deviation|Mean
2804880|NCT00488618|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate.|Baseline, Week 3|Intent-to-treat Population included Participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment, last observation carried forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
2804881|NCT00488592|Secondary|Clinical Response|Hematological response status|16 weeks|||||||
2804882|NCT00488592|Primary|Efficacy in Inducing or Boosting a Cellular Immune Response|A T-cell response was considered positive if the frequencies of interferon (IFN-γ+) cluster of differentiation (CD8+) T cells in peptide-stimulated peripheral bloody mono-nucleated cells (PBMCs) were 2-fold or more higher than the frequencies of interferon (IFN-γ+) CD8+ T cells in unstimulated PBMCs and if there was a minimum of 0.05% Interferon (IFNγ+) CD8+ T cells (after subtracting the frequencies of interferon (IFNγ+) CD8+ T cells in unstimulated PBMCs). A significant vaccine-induced CD8+ T-cell response was defined as the emergence of detectable PR1 or WT1-specific CD8+ T cells when the pre-study analysis found no response, or a 2-fold increase in frequencies when responses were present before vaccination.|16 weeks||||participants|||Number
2804883|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12|"The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7)."|End of Study/Month 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.|||participants|||Number
2804884|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit|"The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7)."|Screening|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.|||participants|||Number
2804885|NCT00488514|Secondary|Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12|The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.|Baseline and Months 3, 6, 9, and 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.|||points on a scale||Standard Error|Mean
2804886|NCT00488514|Secondary|Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting|The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||treated migraine attacks|||Number
2804887|NCT00488514|Secondary|Number of Migraine Attacks Rated With the Indicated Pain Severity|The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||treated migraine attacks|||Number
2804888|NCT00488514|Secondary|Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet|The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||migraine attacks|||Number
2804891|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
2804892|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
2804893|NCT00488514|Secondary|Number of Treated Migraine Attacks|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.|Baseline through End of Study (up to Month 12)|Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment|||treated migraine attacks|||Number
2804894|NCT00488514|Secondary|Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator|The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.|Screening and Final Visit (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||participants|||Number
2804895|NCT00488514|Secondary|Mean Heart Rate for All Study Participants at the Indicated Time Points|A sitting heart rate was measured once for each participant at each visit.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||beats per minute||Standard Deviation|Mean
2804896|NCT00488514|Secondary|Mean Blood Pressure for All Study Participants at the Indicated Time Points|At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2804897|NCT00488514|Secondary|Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points|BMI = (Weight in kilograms)/(height in centimeters/100)^2|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||kilograms per meters squared||Standard Deviation|Mean
2804898|NCT00488514|Secondary|Mean Weight for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||kilograms||Standard Deviation|Mean
2804899|NCT00488514|Secondary|Mean Height for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.|||centimeters||Standard Deviation|Mean
2804900|NCT00488514|Secondary|Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|"A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490."|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||participants|||Number
2804901|NCT00488514|Secondary|Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|"A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL)."|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.|||participants|||Number
2804917|NCT00488488|Primary|Percentage of Participants With Composite Cure: Nosocomial Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.|||percentage of participants|||Number
2804902|NCT00488514|Secondary|Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet|The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||tablets|||Number
2804903|NCT00488514|Secondary|Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet|The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
2804904|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Gender|The number of participants with adverse events by gender is recorded.|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet|||participants|||Number
2804905|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Race|"The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White."|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet|||participants|||Number
2804906|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Age|The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
2804907|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized Over Time|The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
2804908|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Severity|The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
2804909|NCT00488514|Primary|Number of Participants With the Indicated Drug-related Adverse Events|The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet|||participants|||Number
2804910|NCT00488488|Secondary|Overall Mortality: All Participants|Deaths for any reasons occurring during the study observation period.|Baseline to End of Treatment (up to Day 47)|All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections.|||percentage of participants||95% Confidence Interval|Number
2804911|NCT00488488|Secondary|Reasons for Utilization of Tygacil||Baseline to End of Treatment (up to Day 47)|All participants; n = number of participants with specified reason for utilization of Tygacil.|||percentage of participants|||Number
2804912|NCT00488488|Secondary|Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic|Reasons for change in antibiotic treatment from Tygacil to another antibiotic.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible.|||percentage of participants|||Number
2804913|NCT00488488|Secondary|Antibiotic Agents Chosen for Combination Therapy With Tigecycline|Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil.|||percentage of participants|||Number
2804914|NCT00488488|Secondary|Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure|Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance.|||percentage of participants|||Number
2804915|NCT00488488|Secondary|Participants With Probable Failure at Follow-up|Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants.|||participants|||Number
2804916|NCT00488488|Primary|Percentage of Participants With Composite Cure: Community-acquired Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number participants with community-acquired infections.|||percentage of participants|||Number
2804919|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number of participants with community-acquired infections.|||percentage of participants||95% Confidence Interval|Number
2804920|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.|||percentage of participants||95% Confidence Interval|Number
2804921|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: All Participants|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants: participants exposed to Tygacil who had non-retrospective post-baseline data.|||percentage of participants||95% Confidence Interval|Number
2804922|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy|Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for specified category.|||participants|||Number
2804923|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred during the study.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations.|||participants|||Number
2804924|NCT00488475|Other Pre-specified|Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined low disease activity was classified as a score of <=3.2.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
2804925|NCT00488475|Secondary|Fatigue Visual Analog Scale (VAS)|Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Week 26, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2804926|NCT00488475|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 6, 12, 26, 38, 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time points.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2804927|NCT00488475|Secondary|Patient Global Assessment of Disease Activity|Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2804928|NCT00488475|Secondary|Physician Global Assessment of Disease Activity|Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2804929|NCT00488475|Secondary|Patient Global Assessment of Arthritis Pain|Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2804930|NCT00488475|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||minutes||Full Range|Median
2804931|NCT00488475|Secondary|Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values). Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1. Good and moderate responders were considered to have DAS28 response.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
2804932|NCT00488475|Secondary|Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined remission was classified as a score of <2.6.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
2804933|NCT00488475|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||millimeter per hour (mm/h)||Standard Deviation|Mean
2804934|NCT00488475|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||joints||Standard Deviation|Mean
2804935|NCT00488475|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||joints||Standard Deviation|Mean
2804936|NCT00488475|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2804937|NCT00488475|Secondary|Duration of Working Disability|"Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as 0 if participant was not disable to work during period of assessment. At baseline, participants' duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants' duration of working disability was documented for last 6 months after previous documentation."|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||days||Full Range|Median
2805136|NCT00487240|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint||baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||hypoglycemic events per 30 days||Standard Deviation|Mean
2804938|NCT00488475|Secondary|Duration of Healthcare Resources Utilization|Participants' duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.|||days||Full Range|Median
2804939|NCT00488475|Secondary|Healthcare Resource Utilization|Participants' utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.|||events||Standard Deviation|Mean
2804940|NCT00488475|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||percentage of impairment||Standard Deviation|Mean
2804941|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2804942|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2804943|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52|"Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%."|Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2804944|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26|"Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%."|Week 26|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2804945|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Effect of Weight|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.||||||
2804946|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Clearance|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.||||||
2804947|NCT00488345|Primary|Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment|CR = Cure: resolution of all signs, symptoms (SS) of infection (INF) or improvement, no further antibacterial therapy (AT) necessary; Improved (IMP): SS IMP to extent that switch to oral AT deemed appropriate; Failure: lack of response, required additional AT, initial recovery then deterioration requiring further AT, death due to the INF after day 2, death due to treatment (TR)-related adverse event (AE), required non-routine surgical TR >48 hours after 1st dose of TR due to failure to IMP or clinical worsening. TOC = CR, vital signs, physical exam, laboratory results, concomitant TR, and AEs.|Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)|mITT|||percentage of participants|||Number
2804948|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Volume of Distribution|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.||||||
2804949|NCT00488345|Primary|Weight Normalized Drug Clearance (CLW)|Weight normalized drug clearance measured in liters per hour per kilogram (L/hr/kg). Drug clearance (CL) was determined as the ratio of dose/area under the concentration-time curve from time zero (start of infusion) to 12 hours (start of next infusion) (AUCτ). CLW was determined as the ratio of CL/weight.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.|||L/hr/kg||Standard Deviation|Mean
2804950|NCT00488345|Primary|Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours|AUCτ: AUC between doses from time zero to the time of estimated concentration at 12 hours reported in nanograms * hours divided by milliliters (ng*h/mL) was calculated using the log-trapezoidal rule for decreasing concentrations and the linear-trapezoidal rule for increasing concentrations estimating the 12 hour drug concentration if necessary.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.|||ng*h/mL||Standard Deviation|Mean
2804951|NCT00488345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Time of peak concentration taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|mITT; N = number of participants with evaluable tigecycline concentration data.|||hours||Standard Deviation|Mean
2804952|NCT00488345|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method. Peak concentration was taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|Modified intent to treat (mITT) population: participants who were screened, assigned to study medication and received at least one dose of study medication. N = number of participants with evaluable tigecycline concentration data.|||ng/mL||Standard Deviation|Mean
2804953|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward|"Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (very badly to very well) and how often they have felt drowsy within the previous 7 days (not at all to all the time). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates Very badly and a score of 100 indicates Very well. For daytime drowsiness, a score of 0 indicates Not at all and a score of 100 indicates All the time. Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness."|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2805203|NCT00486954|Secondary|Cmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population|||ng/mL||95% Confidence Interval|Geometric Mean
2804954|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward|"Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (very badly to very well) and how often they have felt drowsy within the previous 7 days (not at all to all the time). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates Very badly and a score of 100 indicates Very well. For daytime drowsiness, a score of 0 indicates Not at all and a score of 100 indicates All the time. Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness."|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804955|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804956|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804957|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804958|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804959|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804960|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2805248|NCT00486824|Secondary|Neonatal Birthweight|Birthweight is presented in grams|Until discharge of mother and neonate from delivery hospital, up to 30 days after delivery|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||grams||Inter-Quartile Range|Median
2804961|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804962|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804963|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804964|NCT00488319|Secondary|Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804965|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804966|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804967|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804976|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Emotions Score|||units on a scale||Standard Deviation|Mean
2804968|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward|The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804969|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Full Range|Median
2804970|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward|Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.|Baseline, Week 104 or the last post-baseline assessment|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804971|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.|||Scores on a scale||Standard Deviation|Mean
2804972|NCT00488319|Primary|The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability|A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 2 years|The safety analysis set was used for the safety analyses and included all enrolled participants who received at least 1 dose of the open-label study drug as recorded on the electronic case report form. This population was considered as evaluable participants.|||Number of Participants|||Number
2804973|NCT00488293|Secondary|Clinical Course Rating Between Baseline and First Clinic Visit|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to First Clinic Visit|Clinical course rating between baseline and first clinic visit, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred.|||participants|||Number
2804974|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Functioning Scores|||units on a scale||Standard Deviation|Mean
2804975|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Functioning Scores|||units on a scale||Standard Deviation|Mean
2805028|NCT00487942|Secondary|Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
2804977|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change score - Emotions Score|||units on a scale||Standard Deviation|Mean
2804978|NCT00488293|Primary|Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change score - Symptoms Score|||units on a scale||Standard Deviation|Mean
2804979|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Symptoms Score|||units on a scale||Standard Deviation|Mean
2804980|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 3 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Composite Score|||units on a scale||Standard Deviation|Mean
2804981|NCT00488293|Secondary|Clinical Course Rating Between Baseline and Month 9|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to Month 9|Clinical course rating between baseline and month 9|||participants|||Number
2804982|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Composite Score.|||units on a scale||Standard Deviation|Mean
2804983|NCT00488059|Secondary|Percentage of Patients With Ongoing Injection Site Reactions (ISRs)||Phase I and II||||Percentage of patients|||Number
2804984|NCT00488059|Secondary|CD4+ Lymphocyte Count Change From Baseline|"Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.~Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16."|Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF|Intent-to-treat|||cells/mm3||Full Range|Median
2804985|NCT00488059|Secondary|Virologic Response Over Time in Phase II of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.|Weeks II-4, 8, 12 & 16|intent-to-treat population|||participants|||Number
2804986|NCT00488059|Secondary|HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study|Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 & LOCF for ITT patients in Phase I of the study|Baseline and Weeks 4, 8, 12 & LOCF|Intent-to-treat population. Last Observation Carried Forward (LOCF) includes non-missing data values from the last post-baseline visit for each participant which was carried forward to impute missing data values.|||log10 copies/mL||Standard Deviation|Mean
2804987|NCT00488059|Primary|Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16||Week II-16|Intent-to-treat population|||participants|||Number
2804988|NCT00488059|Secondary|Virologic Response Over Time in Phase I of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.|Weeks 4, 8 & 12|Intent-to-treat population|||participants|||Number
2804989|NCT00488059|Primary|Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL|Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)|Between Week I-4 and Week I-12 of Phase I of the study|Intent-to-treat population|||participants|||Number
2804990|NCT00488033|Secondary|Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure||4 years||||Participants|||Count of Participants
2804991|NCT00488033|Secondary|Number of Participants With Stroke or Carotid Revascularization Procedure||4 years||||Participants|||Count of Participants
2804992|NCT00488033|Secondary|Number of Participants With Hospitalization for Heart Failure||4 years||||Participants|||Count of Participants
2804993|NCT00488033|Secondary|Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization||4 years||||Participants|||Count of Participants
2804994|NCT00488033|Secondary|Number of Participants Suffering Cardiovascular (CV) Death||4 years||||Participants|||Count of Participants
2804995|NCT00488033|Primary|Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina||4 years||||Participants|||Count of Participants
2804996|NCT00487981|Primary|Pain Rating at 6 Months Post Activation Compared to Baseline||6 months||||Percent reduction||Standard Deviation|Mean
2804997|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.|Baseline|Full analysis set defined as the number of subjects who had at least one observation after baseline|||Participants|||Number
2804998|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.|Week 4|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
2804999|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 2|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.|Week 2|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
2805000|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 1|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.|Week 1|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
2805001|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
2805002|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.|Baseline and 2 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
2805003|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.|Baseline and 1 week|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Participants|||Number
2805004|NCT00487942|Secondary|Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805005|NCT00487942|Secondary|Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805029|NCT00487942|Secondary|Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
2805006|NCT00487942|Secondary|Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805007|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
2805008|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805009|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805010|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805011|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
2805012|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805020|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.|Week 4 or last observation following Baseline|Full analysis set defined as subjects who have at least one observation after Baseline|||Participants|||Number
2805013|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805014|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805015|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
2805016|NCT00487942|Secondary|Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805017|NCT00487942|Secondary|Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805018|NCT00487942|Secondary|Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805019|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline|||Units on a scale||Standard Deviation|Mean
2805435|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-419|FAS|||percentage of participants|||Number
2805021|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one observation after baseline|||Participants|||Number
2805022|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Error|Mean
2805023|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805024|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at least once after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805025|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805026|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805027|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805570|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|4 hours post-dosing|Modified ITT|||participants|||Number
2805030|NCT00487942|Secondary|Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
2805031|NCT00487942|Secondary|Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
2805032|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
2805033|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805034|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805035|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805036|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.|||Units on a scale||Standard Deviation|Mean
2805037|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805068|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
2805038|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805039|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.|||Units on a scale||Standard Deviation|Mean
2805040|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Error|Mean
2805041|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805042|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805043|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.|||Units on a scale||Standard Deviation|Mean
2805044|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805045|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805099|NCT00487747|Primary|Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL|This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
2805046|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805047|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline|||Units on a scale||Standard Deviation|Mean
2805048|NCT00487942|Secondary|Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
2805049|NCT00487942|Secondary|Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
2805050|NCT00487942|Secondary|Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
2805051|NCT00487942|Secondary|Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
2805052|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
2805053|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
2805054|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
2805055|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
2805056|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
2805100|NCT00487747|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL|This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
2805057|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
2805058|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
2805059|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
2805060|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
2805061|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
2805062|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
2805063|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4|||Counts||Standard Deviation|Mean
2805064|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
2805065|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
2805066|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
2805067|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline|||Counts||Standard Deviation|Mean
2805114|NCT00487578|Primary|Mental Efficiency Workload Test (MEWT) Performance Index Score|Cognitive function as measured by Performance Index scores on the Mental Efficiency Workload Test (MEWT). On the performance index scale of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. Tests include: Simple reaction time, Running memory, Matching to sample, Math processing and a sleep scale.|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
2805069|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3|||Counts||Standard Deviation|Mean
2805070|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2|||Counts||Standard Deviation|Mean
2805071|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1|||Counts||Standard Deviation|Mean
2805072|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had a baseline and at least one post-baseline assessment by actigraphy|||Counts||Standard Deviation|Mean
2805073|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test|Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Minutes||Standard Deviation|Mean
2805074|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Categories Completed||Standard Deviation|Mean
2805075|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Responses||Standard Deviation|Mean
2805076|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed."|4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Errors||Standard Deviation|Mean
2805115|NCT00487578|Primary|Headache Impact Test-6 (HIT-6) Score|Impact of headache symptoms on subject's life as measured by HIT-6 questionnaire scores. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact.|Day 0, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
2805116|NCT00487578|Primary|Headache Days|Number of headache days as measured by the Headache Diary|Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
2805117|NCT00487565|Primary|Knee Active Flexion|Active flexion is measured by how much a patient can bend their knee on their own, without assistance.|12 month||||degrees||Standard Deviation|Mean
2805077|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805078|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805079|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805080|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805081|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805082|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805118|NCT00487552|Post-Hoc|Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD)|Endoscopy was performed to determine whether an anastomosis (hole) was successfully created.|Approximately 8-10 days|Patients who underwent a second endoscopy after successful magnet placement|||participants|||Number
2805119|NCT00487552|Primary|Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent|Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.|Approximately 8-10 days||||participants|||Number
2805083|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805084|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805085|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805086|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805087|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805088|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.|Baseline 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805135|NCT00487240|Secondary|Change From Baseline in Absolute Body Weight at 32 Week Endpoint||Baseline, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.|||kilograms||Standard Deviation|Mean
2805571|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|3 hours post-dosing|Modified ITT|||participants|||Number
2805089|NCT00487942|Secondary|Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805090|NCT00487942|Primary|Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.|||Units on a scale||Standard Deviation|Mean
2805091|NCT00487825|Secondary|The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI)|"At each visit (including baseline) the DAS28 and SDAI variables were derived using the following formulas:~DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; SDAI = tender28 + swollen28 + CRP + (PGDA / 10) + (EGDA / 10) where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, CRP is C-reactive protein, PGDA is the patient's global assessment of disease activity and EGDA is the physician's global assessment of disease activity.~The Number of Participants in clinical remission is defined as the DAS28 ≤ 2.6 or SDAI ≤ 3.3."|At 6 weeks, 14 weeks and 24 weeks|Intention to treat (ITT) population|||Participants|||Number
2805092|NCT00487825|Secondary|Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks|At each visit (including baseline) the DAS28 is derived as: DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, PGDA is the patient's global assessment of disease activity. Patients can be scored on a range of 0 to 10. When current DAS < 3.2, good response is defined as >1.2 improvement in DAS from baseline and non-response is improvement of ≤0.6. When current DAS >5.1, non-response is improvement of >0.6 but ≤1.2 . All others are moderate responses.|At 26 weeks|Intention to treat (ITT) population|||Percentage of Participants|||Number
2805093|NCT00487825|Secondary|Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone|"A patient was considered as improved according to the criteria of ACR 20 equaling at least 20%, ACR70 = 70%, and ACR90 = 90% improvement in the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|At 6 weeks, 14 weeks, and 26 weeks|Intent-to-treat population (ITT)|||Participants|||Number
2805094|NCT00487825|Primary|Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50)|"A patient was considered as improved according to the ACR50 criteria if she/he had at least a 50 % improvement in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6, 14, and 26 weeks of treatment|Intent-to-treat population (ITT)|||Participants|||Number
2805095|NCT00487747|Secondary|Mean Change in Laboratory Parameters (ALT Levels)|Mean Change in Laboratory parameters (ALT levels) is reported.|From Screening (Day 0) to Week 96|Safety population included all participants who received at least one dose of the study drug.|||International units per liter (IU/L)||Standard Deviation|Mean
2805096|NCT00487747|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.|Up to Week 96|Safety population included all participants who received at least one dose of the study drug.|||Participants|||Number
2805097|NCT00487747|Secondary|Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT|Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
2805098|NCT00487747|Secondary|Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion|Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.|Week 96|All participants who received at least one dose of the study drug were considered for analysis.|||Participants|||Number
2805101|NCT00487721|Primary|Measurable Silibinin Tissue Levels|To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.|At the time of surgery|Per protocol analysis was used and 6 participants that were enrolled in the study were included in the analysis.|||Participants|||Number
2805102|NCT00487695|Secondary|Mean Number of Biopsies Taken in Barrett's Surveillance Patients|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete, the study, no comparison could be made. The patients in this analysis were referred for surveillance of Barrett's esophagus (no suspected neoplasia).|||mean number of biopsies||Full Range|Mean
2805103|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.|||number of biopsies with neoplasia||Full Range|Mean
2805104|NCT00487695|Secondary|Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients|Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed).|||percent yield for neoplasia|||Number
2805105|NCT00487695|Secondary|Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.|6 weeks|per protocol as participants would only have data to compare if they completed both endoscopies|||mean number of biopsies||Full Range|Mean
2805106|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.|||mean number of biopsies with neoplasia||Full Range|Mean
2805107|NCT00487695|Primary|Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)|The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed. This analysis looks specifically at patients with Barrett's and suspected (but not known) neoplasia.|||percent yield for neoplasia|||Number
2805108|NCT00487669|Secondary|Overall Survival||time from study entry until death||||months||95% Confidence Interval|Median
2805109|NCT00487669|Secondary|Time to Progression||time from study entry until the first documented sign of progression||||months||95% Confidence Interval|Median
2805110|NCT00487669|Primary|To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.||CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)||||participants|||Number
2805111|NCT00487578|Secondary|Sustained Treatment Effect|Sustained treatment effect as measured by the MEWT Performance Index score compared to change in number of Headache Days. Results would be presented in the form of a correlation analysis. There is an expected negative correlation as performance index increases and number of headache days decrease (a correlation of -1).|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
2805112|NCT00487578|Secondary|Quality of Life Scores|"Quality of life as measured by Migraine Specific Quality of Life questionnaire (MSQ) scores. 14 questions ask how often headaches have interfered with specific daily activities in previous 4 weeks. 6-point scale ranges from None of the time to All of the time."|Day 0, Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
2805113|NCT00487578|Secondary|Overall Satisfaction With Medication Score|Subject overall satisfaction with effectiveness of the therapy as measured by score on the Satisfaction with Medication questionnaire. Scale range: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied.|Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.||||||
2807204|NCT00470158|Primary|Incidence of Diarrhea|A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.|6 months||||episodes|||Number
2805120|NCT00487539|Secondary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6|The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.|Baseline to Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a Scale||Standard Deviation|Mean
2805121|NCT00487539|Secondary|Number of Participants With Mucosal Healing at Week 6|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.|||Participants|||Number
2805122|NCT00487539|Secondary|Number of Participants With Clinical Remission at Week 6|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.|||Participants|||Number
2805123|NCT00487539|Primary|Number of Participants With Clinical Response at Week 6|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Baseline, Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.|||Participants|||Number
2805124|NCT00487461|Secondary|To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.|6 months|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.||||||
2805125|NCT00487461|Primary|To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH||21 days|Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.||||||
2805126|NCT00487435|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The subjects indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, 52 weeks|observed cases|||Scores on a Scale||Standard Deviation|Mean
2805127|NCT00487435|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized subjects who took at least one dose of study medication).|||participants|||Number
2805128|NCT00487396|Secondary|The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related.||four months from enrollment|||||||
2805129|NCT00487396|Secondary|Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present.||four months from enrollment|||||||
2805130|NCT00487396|Primary|The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related|The number of positive findings related to Crohn that were detected by capsule endoscopy procedure and ileo-colonoscopy as compared to the number of findings related to Crohn that were detected by ileo-colonoscopy and small bowel follow through(SBFT) procedures.|four months from enrollment|Findings were catagorized (ulcers, inflammatory lesions, stricturing lesions and others) and for each category, the numbers of found and missed pathologies, i.e. the detection capabilities, were calculated for the combination of the procedures (i.e. CE and IC vs. SBFT and IC) and were limited to one count per location (SB, terminal ileum, colon).|||Number of findings|||Number
2805131|NCT00487279|Secondary|Arrhythmic Mortality|Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.|Total survival will be evaluated 2 years after the last patient is randomized.||||participants|||Number
2805132|NCT00487279|Primary|All-cause Mortality||Total survival will be evaluated 2 years after the last patient is randomized.|Intent to Treat|||participants|||Number
2805133|NCT00487240|Secondary|Insulin Dose (Total and By Component [Basal and Bolus])|Total daily insulin dose (U/day) was assessed.|32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||units of insulin per day (U/day)||Standard Deviation|Mean
2805134|NCT00487240|Secondary|Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])|Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||units of insulin per kilogram per day||Standard Deviation|Mean
2805137|NCT00487240|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||hypoglycemic events per 1 year||Standard Deviation|Mean
2805138|NCT00487240|Secondary|Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||episodes of hypoglycemia|||Number
2805139|NCT00487240|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2805140|NCT00487240|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint|Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2805141|NCT00487240|Secondary|Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%||32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||percentage of participants|||Number
2805142|NCT00487240|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values|"The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline."|Baseline, 8,16, 24, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.|||percent of HbA1c||Standard Error|Least Squares Mean
2805143|NCT00487240|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint||baseline and 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||percent of HbA1c||Standard Error|Least Squares Mean
2805144|NCT00487188|Secondary|Number of Participants With Adverse Events (AEs) During the Induction Phase|A serious AE (SAE) is an event which: results in death, is life-threatening, disabling or incapacitating; is a congenital anomaly in the offspring of a patient who received study drug; requires or prolongs inpatient hospitalization; jeopardizes the patient or require medical or surgical intervention to prevent one of the outcomes above; any Grade 4 laboratory value considered by the investigator clinically significant or that requires an action; any injection site reaction that meets SAE criteria above. Non-serious AEs reported include pneumonia and non-serious AEs that led to discontinuation.|Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32)|Safety Population|||participants|||Number
2805145|NCT00487188|Secondary|Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase|Improvement of CD4+ count defined as having from 100 to less than 200 CD4+ cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of ≥100 to <200 cells/mm^3.|||percentage of participants|||Number
2805146|NCT00487188|Secondary|Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase|Maintenance of CD4+ count defined as having greater than or equal to 200 cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of greater than or equal to 200 cells/mm^3.|||percentage of participants|||Number
2805147|NCT00487188|Secondary|Number of Participants With Virological Failure During the Maintenance Phase|Virological failure was defined by 2 consecutive HIV-1 RNA values ≥ 400 copies/mL during the Maintenance Phase.|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)|||Participants|||Number
2805148|NCT00487188|Secondary|Time to Virological Failure During the Maintenance Phase|"Time to virological failure (defined as HIV-1 RNA ≥ 400 copies/mL) was counted from Baseline 2 until the first of the two consecutive ≥400 copies/mL measurements.~Only patients who were qualified for entering the Maintenance Phase were included in the analyses."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)|||days||Inter-Quartile Range|Median
2805149|NCT00487188|Secondary|Time to Loss of Viral Response During the Maintenance Phase|"The time to loss of viral response (defined as HIV-1 RNA <50 copies/mL) was counted from Baseline 2 until the first of two consecutive ≥50 copies/mL measurements.~Only patients who were qualified for entering the Maintenance Phase were included in the analysis."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)|||days||Inter-Quartile Range|Median
2805572|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1.5 hours post-dosing|Modified ITT|||participants|||Number
2805150|NCT00487188|Secondary|Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts|Change from Baseline in CD4 Cell Counts at Week 48. Least squares means were calculated from an ANCOVA model with treatment and baseline CD4 count as independent variables.|Baseline 1 and Week 48|Intent-to-Treat Population 2 (ITT2) population (patients evaluable for efficacy in the Maintenance Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 48 or who withdrew prior to the week 48 time window.|||cells/mm^3||95% Confidence Interval|Least Squares Mean
2805151|NCT00487188|Secondary|Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Maintenance Phase who maintained HIV-1 RNA < 50 copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Maintenance Phase Intent-to-Treat Population 2 (ITT2).|||percentage of participants|||Number
2805152|NCT00487188|Secondary|Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Induction Phase who maintained HIV-1 RNA < 50 Copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Induction Phase Intent-to-Treat Population 1 (ITT1).|||percentage of participants|||Number
2805153|NCT00487188|Secondary|Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts|Change from Baseline in CD4+ Cell Counts at Week 24. Least squares means were calculated from an ANCOVA model with treatment as an independent variable.|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.|||cells/mm^3||95% Confidence Interval|Least Squares Mean
2805154|NCT00487188|Secondary|Change From Baseline to Week 24 in Viral Load|"Change from Baseline in log10 HIV-1 RNA at Week 24. Least squares means were calculated from an analysis of covariance (ANCOVA) model with treatment, a flag variable removed ENF at re-randomization and Baseline viral load as independent variables."|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.|||log10 copies/mL||95% Confidence Interval|Least Squares Mean
2805155|NCT00487188|Secondary|Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 400 copies/mL) by Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by Week 28 were considered as non-responders.|From Baseline 1 to Week 28|ITT1 population (patients evaluable for efficacy in the induction phase)|||Participants|||Number
2805156|NCT00487188|Secondary|Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase|"The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements.~Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24."|Baseline 1 until Week 28.|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase).|||days||Inter-Quartile Range|Median
2805157|NCT00487188|Primary|Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.|From Baseline 1 to Week 28|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase)|||Participants|||Number
2805158|NCT00487162|Secondary|Hemodynamic Instability||0-48 hours post op|no analysis was done as the study was terminated due to patient safety concerns||||||
2805159|NCT00487162|Primary|Wound Infection||7-10 days post op|no analysis was done as the study was terminated due to patient safety concerns||||||
2805160|NCT00487084|Secondary|Supplemental Analgesia in First 48 Hours|Participants requesting supplemental analgesia in first 48 hours|48 hours||||Participants|||Number
2805161|NCT00487084|Primary|Supplemental Analgesia in First 90 Minutes|Participants requesting supplemental analgesia in the first 90 minutes following study drug|90 min||||participants|||Number
2805162|NCT00487084|Secondary|Verbal Rating Score (0 to 10) for Pain (VRPS)|Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable|At recovery room entry|Verbal Rating Score for Pain (0-10) where 0 = no pain and 10 = worst pain imaginable|||Scores on a scale||Inter-Quartile Range|Median
2805163|NCT00487084|Primary|Duration of Continuing Analgesia|Time to first request for supplemental analgesia|48 hours|All participants receiving the intervention were analyzed|||hours||95% Confidence Interval|Median
2805164|NCT00486954|Secondary|Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib|An inadequate number of tissue samples were obtained; thus, analysis could not be performed.|Pretreatment|ITT Population||||||
2805165|NCT00486954|Secondary|Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study|"HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, HER2 negative; score of 2+, borderline; score of 3+, HER2 positive."|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.|||participants|||Number
2805573|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1 hour post-dosing|Modified ITT|||participants|||Number
2805166|NCT00486954|Secondary|Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study|EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; <3+ indicates negative EGFR expression.|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.|||participants|||Number
2805167|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805168|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805169|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805170|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805171|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805172|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805173|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805174|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805175|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805176|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805177|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805178|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805179|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805180|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805181|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805182|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805348|NCT00486018|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2805183|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805184|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805185|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805186|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805187|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805188|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805189|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2805190|NCT00486954|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.|||scores on a scale||Standard Deviation|Mean
2817507|NCT00400829|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to death from any cause, assessed up to 5 years||||Months||95% Confidence Interval|Median
2805191|NCT00486954|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study|The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.|From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)|Safety Population: all participants who were randomized and took at least one dose of study medication|||participants|||Number
2805192|NCT00486954|Secondary|Duration of Response in the Randomized Part of the Study|Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.|up to 18.27 months|ITT Population. Only those participants achieving a CR or PR were assessed.|||months||95% Confidence Interval|Median
2805193|NCT00486954|Secondary|Number of Participants With the Indicated Time to Response in the Randomized Part of the Study|Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.|up to 5.62 months|ITT Population. Only those participants achieving a CR or PR were assessed.|||Participants|||Number
2805194|NCT00486954|Secondary|Percentage of Participants With Overall Response in the Randomized Part of the Study|Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|From randomization up to 5.62 months|ITT Population|||Percentage of participants|||Number
2805195|NCT00486954|Secondary|Time to Progression in the Randomized Part of the Study|Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to disease (up to 42.35 months )|ITT Population|||months||95% Confidence Interval|Median
2805196|NCT00486954|Secondary|Progression-free Survival (PFS) in the Randomized Part of the Study|PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to any cause (up to 42.35 months)|ITT Population. For participants whose disease did not progress or who did not die, PFS was censored at the time of the last independently assessed radiological scan preceding the initiation of any alternate anti-cancer therapy.|||months||95% Confidence Interval|Median
2805197|NCT00486954|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.|Days 1 and 8|PK Parameter Population|||liters per square meter||95% Confidence Interval|Geometric Mean
2805198|NCT00486954|Secondary|Clearance of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Days 1 and 8|PK Parameter Population|||liters per hour per square meter||95% Confidence Interval|Geometric Mean
2805199|NCT00486954|Secondary|Half-life of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.|Days 1 and 8|PK Parameter Population|||hr||95% Confidence Interval|Geometric Mean
2805200|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.|Days 1 and 8|PK Parameter Population|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2805201|NCT00486954|Secondary|AUC(0-24) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.|Days 1 and 8|PK Parameter Population|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2805202|NCT00486954|Secondary|Tmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population|||hr||Full Range|Median
2805204|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.|Days 8 and 14|PK Parameter Population|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2805205|NCT00486954|Secondary|Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population|||hours (hr)||Full Range|Median
2805206|NCT00486954|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study|Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population: all participants for whom the PK parameter could be estimated|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2805207|NCT00486954|Primary|Overall Survival (OS) in the Randomized Part of the Study|OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.|From randomization until death due to any cause (up to 42.58 months)|Intent-to-Treat Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication|||months||95% Confidence Interval|Median
2805208|NCT00486954|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study|DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.|28 days|Safety Population (Pilot part): all participants who received at least one dose of investigational product in the Pilot part of the study|||Participants|||Number
2805209|NCT00486902|Post-Hoc|Pain Score (0-10) at 2 Weeks Following Cesarean Delivery|Numeric rating for pain score (0 to 10) reported at 2 weeks following cesarean delivery. Zero is no pain and 10 is worst pain imaginable.|2 weeks||||Scores on a scale||Inter-Quartile Range|Median
2805210|NCT00486902|Secondary|Disturbing Dreams|Number of subject reporting disturbing dreams at 72 hours post cesarean delivery|72 hours||||participants|||Number
2805211|NCT00486902|Secondary|Postperative Pruritus|Number of subjects with pruritus in the first 24 hours following cesarean delivery|24 hours||||participants|||Number
2805212|NCT00486902|Secondary|Postoperative Vomiting|Number of subjects that vomited in the first 24 hours following cesarean delivery|24 hours||||participants|||Number
2805213|NCT00486902|Secondary|Postoperative Nausea|Number of subjects reporting nausea in first 24 hours following cesarean delivery|24 hours||||participants|||Number
2805214|NCT00486902|Secondary|Cumulative Hydrocodone/Acetaminophen for Supplemental Analgesia to Treat Breakthrough Pain|Cumulative hydrocodone/acetaminophen for supplemental analgesia to treat breakthrough pain for 72 hours following cesarean delivery|72 hours|Analysis was per protocol|||tablets||Inter-Quartile Range|Median
2805215|NCT00486902|Secondary|Verbal Pain Scores (0 to 10) at First Analgesia Request|Numeric rating of pain scores (NRS) scale (0 to 10) at time of supplemental analgesia request. Zero is no pain and 10 is worst pain imaginable.|24 hours||||Scores on a scale||Inter-Quartile Range|Median
2805216|NCT00486902|Primary|Number of Subjects Requiring Supplemental Analgesia in the First 24 Hours Following Cesarean Delivery|Request for oral hydrocodone/acetaminophen for pain not controlled by around the clock non-steroidal antiflammatory drugs in the first 24 hours following cesarean delivery.|24 hours|Analysis was performed per protocol|||participants|||Number
2805217|NCT00486863|Secondary|4-hydroxy Praziquantel Pharmacokinetic Concentrations|Since pregnancy is associated with increased cytochrome P450 activity and physiologic changes in the gastrointestinal tract that tend to reduce drug absorption, praziquantel pharmacokinetics may be affected by pregnancy. Thus, the metabolite-to-parent drug ratio may serve as a differential marker to help determine if variability in drug exposure following oral administration during pregnancy is due to altered metabolism or drug absorption. Samples that were collected from subjects who were randomized to receive praziquantel were analyzed for praziquantel and 4-hydroxy praziquantel concentrations. Assays were performed using high performance liquid chromatography-electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory. Descriptive statistics were obtained for concentrations at each of the four sparse sampling timepoints.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).|||ng/ml||Inter-Quartile Range|Median
2805229|NCT00486863|Secondary|Newborn Median Serum Transferrin Receptor:Ferritin Ratio|To assess total body iron, the serum transferrin receptor:ferritin ratio was assessed in the infant. At delivery, a heel stick blood sample and a cord blood sample were collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio.|0-6 days after delivery.|All infants for whom transferrin receptor and ferritin were reported are included in the analysis.|||ratio||Inter-Quartile Range|Median
2805230|NCT00486863|Secondary|Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation|Maternal fat stores were measured by thigh skinfold thickness obtained using a Holtain skinfold caliper. The thickness increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom thigh skinfold thickness was reported at both timepoints were included in this analysis.|||millimeters||Standard Deviation|Mean
2817535|NCT00400686|Primary|Change From Baseline in Hemoglobin at Day 28|Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.|Baseline to Day 28||||g/dL||Full Range|Median
2805218|NCT00486863|Secondary|Praziquantel Pharmacokinetic Concentrations|Two plasma samples were collected during the overnight hospitalization from approximately 200 subjects that remained at the time of study modification to incorporate PK studies. Subjects had samples collected based on one of two sample collection strategies: 4.5 and 8 hr after the first praziquantel dose or 6 and 10 hr after the first praziquantel dose. Subjects randomized to an even study number were assigned to the 4.5 and 8 hour schedule. Subjects randomized to an odd study number were assigned to the 6 and 10 hour schedule. Samples only from subjects randomized to receive praziquantel were analyzed for praziquantel. Samples drawn from subjects randomized to the control group were not analyzed. Praziquantel concentrations (ng/ml) were assayed using high performance liquid chromatography-electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).|||ng/mL||Inter-Quartile Range|Median
2805219|NCT00486863|Secondary|Cytokeratin 18 Neo-epitope Staining as a Measure of Apoptosis|A study hypothesis was that peripheral serum obtained from S. japonicum infected, treated mothers would induce a lower level of apoptosis (programmed cell death) in cultured trophoblasts as measured by cytokeratin 18 neo-epitope staining compared to peripheral serum obtained from S. japonicum infected, PZQ untreated mothers. This assay was planned to be completed only if the primary objective was met; therefore, there will be no data for this outcome measure.|32 weeks gestation|||||||
2805220|NCT00486863|Secondary|Placental Blood Cytokine Levels|Cytokine assays were planned to be performed with culture supernatant harvested from placental explant cultures. The cytokines were to be measured with a multi-analyte analyzer. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At delivery|||||||
2805221|NCT00486863|Secondary|Maternal Serum Cytokine Levels of TNF-alpha, TNF-alpha Receptors I and II, IL-1, and IL-6|Extra-placental mechanisms mediating improved outcomes in the PZQ group were planned to be evaluated with maternal serum cytokine levels, particularly TNF-alpha, TNF-alpha receptors I and II, IL-1, and IL-6. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At 32 weeks gestation|||||||
2805222|NCT00486863|Secondary|Number of Participants With Pre-eclampsia|Participants were assessed for the presence of pre-eclampsia at both the 22 and 32 week visits. Pre-eclampsia was defined by the presence of proteinurea (2+ protein on urine dipstick) and a single diastolic blood pressure reading of 100 millimiters of mercury (mm Hg) or above OR more than one reading, four hours apart, of 90 mm Hg or above.|22 weeks and 32 weeks|All participants seen at both timepoints are included.|||participants|||Number
2805223|NCT00486863|Secondary|Number of Participants Whose Infant Was Born With Congenital Anomalies|The newborn was examined by the midwife at delivery and within 2-6 days of delivery to assess the presence of congenital anomalies and well-being. The newborn was also examined by study pediatrician at 28 days of life.|At delivery, within 2-6 days of delivery, and at 28 days|All newborns are included in the analysis.|||participants|||Number
2805224|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Clinical Chemistry Assessments Within 24 Hours of Dosing|Toxicity to maternal kidney and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. Any values that were 1.1 times the upper limit of normal or greater for the parameter were considered abnormal.|Just before and 24 hours after dosing|All participants were included in this analysis.|||participants|||Number
2805225|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Hematology Assessments Within 24 Hours of Dosing|Toxicity to maternal bone marrow, kidney, and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline complete blood count, including white blood count (WBC), platelets, and hemoglobin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. White blood count was abnormal at or above 10,800 or at or below 3500 cells/square millimeter (sq mm), platelets were abnormal at or below 140,000 cells/sq mm, and hemoglobin was abnormal at or below 10.9 grams/deciliter (g/dL).|Just before and 24 hours after dosing|All participants were included in this analysis.|||participants|||Number
2805226|NCT00486863|Secondary|Number of Participants Experiencing Fetal Loss by Abortion|Abortion was defined by the protocol as bleeding followed by fetal loss as supported by ultrasound before 20 weeks gestation. Abortion was an important safety outcome measure due to the fact that abortion would occur closer to the time of dosing than miscarriage or stillbirth. Participants were observed in hospital for 24 hours after dosing and asked to return for any bleeding at any time.|After dosing and before 20 weeks gestation|All participants were included in this analysis.|||participants|||Number
2805227|NCT00486863|Secondary|Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing|Participants were observed in hospital for 24 hours after dosing for serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof (for reasons other than the 24-hour observation period); resulted in a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of these outcomes.|Within 24 hours of dosing|All participants were included in this analysis.|||participants|||Number
2805228|NCT00486863|Secondary|Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent|Parasitologic response to treatment was evaluated by counting S. japonicum eggs per gram of stool at screening and again at 22 weeks gestation. Success of treatment was pre-specified as greater than 90 percent reduction in egg count from screening to 22 weeks gestation.|Screening and 22 weeks gestation|All participants for whom egg counts were reported are included in the analysis.|||participants|||Number
2805231|NCT00486863|Secondary|Mean Change in Maternal Weight From 14 to 32 Weeks Gestation|Maternal weight gain was assessed by measuring participants' weight in kilograms. The weight increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom weight was reported at both timepoints were included in this analysis.|||kilograms||Standard Deviation|Mean
2805232|NCT00486863|Secondary|Median Maternal Hepcidin at 32 Weeks Gestation|Anemia of inflammation was assessed via maternal urine hepcidin levels. In response to inflammation, elevated serum levels of hepcidin is synthesized. Hepcidin causes sequestration of iron from bio-available forms to storage forms such as ferritin and decreases intestinal absorption of iron. Hepcidin was measured in participants' urine at 32 weeks gestation.|32 weeks gestation|All participants for whom hepcidin levels were reported are included in the analysis.|||nanograms/milliliter||Inter-Quartile Range|Median
2805233|NCT00486863|Secondary|Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation|To assess total body iron, one needs to assess the storage compartment, which will contain sequestered iron, and the functional compartment, which represents bioavailable iron. Body iron status is defined by the two laboratory measurements that reflect these compartments, ferritin and serum transferrin receptor. The serum transferrin receptor:ferritin ratio has been shown in quantitative phlebotomy studies to provide an accurate assessment of total body iron over the entire range of status. At 14 and 32 weeks gestation, a blood sample was collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio. Each participant's change in ratio was calculated, and the median and interquartile range were determined for each group.|14 weeks and 32 weeks gestation|All participants for whom transferrin receptor:ferritin ratio was reported at both timepoints are included in the analysis.|||ratio||Inter-Quartile Range|Median
2805234|NCT00486863|Secondary|Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation|Hemoglobin concentration in a venous blood sample collected at 14 and 32 weeks gestation was measured using a multi-analyte analyzer. Each participant's change in hemoglobin concentration between the two timepoints was determined, and the mean and standard deviation for each group calculated.|14 weeks and 32 weeks gestation|All participants for whom hemoglobin concentrations were reported are included in the analysis.|||grams/deciliter||Standard Deviation|Mean
2805235|NCT00486863|Secondary|Number of Participants Whose Pregnancy Resulted in a Live Birth|Each participant was followed until delivery to record if the outcome of the pregnancy was a live birth. Live births were defined as the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord had been cut or the placenta was attached.|At delivery|All participants for whom the status of the infant at delivery was reported are included in the analysis.|||participants|||Number
2805236|NCT00486863|Primary|Mean Newborn Birth Weight|Birth weight was collected for live infants at the time of delivery by a trained midwife, or within 24 hours of delivery for participants who chose to deliver at home with a helot, a birth attendant without formal training.|Within 24 hours of delivery.|All newborns for whom birth weights were reported were included in the analysis.|||kilograms||Standard Deviation|Mean
2805237|NCT00486837|Secondary|Change in Neutrophil Number in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 21 out of 28 subjects had applicable data to analyze. For Group 2, only 22 out of 28 subjects had applicable data to analyze.|||percentage of change||Standard Deviation|Mean
2805238|NCT00486837|Secondary|Change in Pseudomonas Load in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.|||CFU/g||Standard Deviation|Mean
2805239|NCT00486837|Secondary|Change in Total Bacterial Load in Induced Sputum From Baseline to Week 4||Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.|||CFU/g||Standard Deviation|Mean
2805240|NCT00486837|Secondary|Change in Total Immunoglobulin G (IgG) Fragments in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 26 out of 28 subjects had applicable data to analyze.|||ug/mL||Standard Deviation|Mean
2805241|NCT00486837|Secondary|Change in Alpha-1-anti-trypsin (A1AT) Activity in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 27 out of 28 subjects had applicable data to analyze.|||ug/mL||Standard Deviation|Mean
2805242|NCT00486837|Primary|Change in Free Elastase in Induced Sputum From Baseline to Week 4||Baseline vs Week 4|Modified Intent-to-Treat Population (mITT) was all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (free elastase in induced sputum) post baseline and at baseline (Visit 2).|||ug/mL||Standard Deviation|Mean
2805243|NCT00486824|Secondary|Time to Uterine Quiescence|Uterine quiescence was defined as six or fewer uterine contractions per hour. Outcome was described as days.|Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||days||Inter-Quartile Range|Median
2805244|NCT00486824|Secondary|Count of Participants With Side-effect Due to the Medication|Monitored side-effects for this outcome included abdominal pain, blood pressure change, GI-symptoms and skin rash.|Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||Participants|||Count of Participants
2805245|NCT00486824|Secondary|Count of Participants With Neonatal Morbidity|Neonatal morbidity included admission to neonatal intensive care unit, respiratory distress or sepsis.|Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||Participants|||Count of Participants
2805246|NCT00486824|Secondary|Days From First Medication Initiation to Delivery as a Measure of Delay in Delivery||Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||days||Inter-Quartile Range|Median
2805247|NCT00486824|Secondary|Gestational Age at Delivery||Up to 42 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||weeks||Inter-Quartile Range|Median
2805249|NCT00486824|Primary|Count of Patients With Recurrent Preterm Labor Within Two Weeks of Randomization|Preterm labor was defined as documented cervical change and regular uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% cervical effacement. Preterm labor is defined as uterine contractions occurring up to 37 weeks of pregnancy.|Two weeks after enrolled and randomized, up to 37 weeks of pregnancy|Participants with accessible data are included in the analysis. Not all data were accessible due to patient data privacy regulations.|||Participants|||Count of Participants
2805250|NCT00486811|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation."|Change from Baseline to Week 12 of the Maintenance Period|Safety Set|||Units on a scale||Standard Deviation|Mean
2805251|NCT00486811|Secondary|Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)|"The Sleep Questionnaire addressed the following question: Please rate the overall quality of your sleep last night? The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number of participants reporting the appropriate sleep quality category are shown.|||participants|||Number
2805252|NCT00486811|Secondary|Sleep Questionnaire: Number of Awakenings During Sleep|"The Sleep Questionnaire addressed the following question: How many times did you wake up during the night?. Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep."|Week 12 of the maintenance period compared with baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number reflects the number of participants that had the specified awakenings.|||participants|||Number
2805253|NCT00486811|Secondary|Sleep Questionnaire: Amount of Time Slept in Hours|"The Sleep Questionnaire addressed the following question: How long did you sleep last night?. The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied."|Baseline to Week 12 of the maintenance period|Intention to treat (ITT). Last Observation Carried Forward (LOCF)|||hours||Standard Deviation|Mean
2805254|NCT00486811|Secondary|Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.|"The Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night(hours)?. The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||hours||Standard Deviation|Mean
2805255|NCT00486811|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Comparison of Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||Index value||Standard Error|Mean
2805256|NCT00486811|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|Change From Baseline to Week 12 of the Maintenance Period|The number indicate the available responses. For certain categories, e.g. Physical Functioning only 318 participants in the tapentadol treatment were analyzed and in the General Health analysis only 328 oxycodone- and 336 placebo-treated participants were available. Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
2805257|NCT00486811|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint.|Baseline to week 12 of the maintenance period|Intention to treat (ITT) The results for median and interquartile ranges were not estimated as an insufficient number of participants discontinued due to lack of efficacy to estimate values.||||||
2805258|NCT00486811|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling.|Change from baseline to week 12 of the maintenance period|Intention to treat (ITT). No imputation performed.|||units on a scale||Standard Deviation|Mean
2805259|NCT00486811|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of 12 week maintenance period|Intention to treat (ITT). Last observation carried forward (LOCF). Assessments obtained more than one day after end of treatment were not included in the analysis.|||participants|||Number
2805315|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||hours||Standard Deviation|Mean
2805260|NCT00486811|Secondary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain intensity."|Change from Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2805261|NCT00486811|Primary|Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS).|"For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain."|Change from baseline over the 12 week Maintenance Period|Intent-to-treat (ITT), Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
2805262|NCT00486759|Secondary|Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma|OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.|At the end of treatment (Cycle 8, up to 12 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.|||Percentage of patients|||Number
2805263|NCT00486759|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.|||Months||Inter-Quartile Range|Median
2805264|NCT00486759|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.|||Months||Inter-Quartile Range|Median
2805265|NCT00486720|Primary|Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.||Every 21 days while on therapy and at 30 days after the last dose of study therapy||||Participants|||Number
2805266|NCT00486720|Primary|Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria|Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.|2 Years|Full analysis set (FAS) population is the analysis population. This population consists of all randomized patients who have received at least one dose of study medication.|||Participants|||Number
2805267|NCT00486642|Other Pre-specified|Survival Rate|Calculated by Kaplan and Meier.|At 1 year|Very little death information is captured for this study so OS analysis was not done.||||||
2805268|NCT00486642|Other Pre-specified|Median Survival Time|Calculated by Kaplan and Meier|Up to 1 year after completion of treatment|Very little death information is captured for this study so OS analysis was not done.||||||
2805269|NCT00486642|Secondary|Toxicity|Patients who came off treatment due to toxicity.|Assessed up to 5 years||||participants|||Number
2805270|NCT00486642|Secondary|Time to Disease Progression|Earliest date on which disease progression was determined by any of the methods listed: PSA progression, objective disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer-related symptomatic progression.|Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years||||months||95% Confidence Interval|Median
2805271|NCT00486642|Secondary|Stable Disease Rate as Assessed by RECIST Criteria|RECIST Stable defined as - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Measured from the start of the treatment until the criteria for progression are met or death from any cause, whichever came first, assessed up to 5 years|5 evaluable patients in Arm A + 9 evaluable patients in Arm B|||Participants|||Count of Participants
2805316|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||hours||Standard Deviation|Mean
2805272|NCT00486642|Secondary|Median Duration of PSA-Response|"Definition of PSA response: >= 50% fall (minimum 5 ng/ml) in PSA from baseline maintained for >4 weeks, and without other evidence of disease progression documented at time of confirmatory values.~PSA response duration will commence on the date of the first >=50% decline in PSA. The response duration ends when PSA progression criteria are met with the second increasing PSA value.~PSA progression in PSA responders: rise in PSA of 50% (minimum 5ng/ml) above nadir value and confirmed by a second increasing value at least 1 week later."|From time PSA response criteria are met until time PSA progression criteria are met or death from any cause, whichever came first, up to 5 years|1 patient in Arm A and 2 patients in Arm B had a PSA response.|||months||Full Range|Median
2805273|NCT00486642|Secondary|Progression-free Survival|"PFS is defined as the time from treatment initiation to disease progression or death from any cause, whichever came first.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|From time of treatment initiation to disease progression or death from any cause, whichever came first, assessed up to 5 years||||months||95% Confidence Interval|Median
2805274|NCT00486642|Secondary|Objective Tumor Response Rate as Assessed by RECIST Criteria|RECIST PR defined as - At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 years|5 evaluable patients in Arm A + 9 evaluable patients in Arm B|||patient|||Number
2805275|NCT00486642|Primary|PSA Response Rate|Prostate-specific antigen (PSA) response rate (defined as a confirmed > / = 50% decline (minimum 5ng/ml) in PSA from baseline maintained for >4 weeks, and without other evidence of disease progression documented at time of confirmatory values).|Up to 12 weeks|9 evaluable in Arm A + 12 evaluable in Arm B|||Participants|||Count of Participants
2805276|NCT00486603|Secondary|PK of Hydroxychloroquine as Measured by First-order Absorption Rate Constant (Ka)|The population model PK parameters do not specifically represent steady-state values, as they were determined from multiple repeated single doses taken from multiple repeated doses taken by the individual patient during their period on the study. To obtain steady state PK parameters, individual estimates were simulated from the population model.|up to 276 days|Only participants from Phase II were assessed for this outcome measure. Data was not collected from 4/76 participants.|||hours||Full Range|Mean
2805277|NCT00486603|Secondary|PK of Hydroxychloroquine as Measured by Distribution Volume of Peripheral Compartment (V2/F)|The population model PK parameters do not specifically represent steady-state values, as they were determined from multiple repeated single doses taken from multiple repeated doses taken by the individual patient during their period on the study. To obtain steady state PK parameters, individual estimates were simulated from the population model.|up to 276 days|Only participants from Phase II were assessed for this outcome measure. Data was not collected from 4/76 participants.|||Liters||Full Range|Mean
2805278|NCT00486603|Secondary|PK of Hydroxychloroquine as Measured by Volume of Distribution of Central Compartment (V/F)|The population model PK parameters do not specifically represent steady-state values, as they were determined from multiple repeated single doses taken from multiple repeated doses taken by the individual patient during their period on the study. To obtain steady state PK parameters, individual estimates were simulated from the population model.|up to 276 days|Only participants from Phase II were assessed for this outcome measure. Data was not collected from 4/76 participants.|||Liters||Full Range|Mean
2805279|NCT00486603|Secondary|PK of Hydroxychloroquine as Measured by Oral Clearance (Liters/Hour) From Central Compartment (CL/F)|The population model PK parameters do not specifically represent steady-state values, as they were determined from multiple repeated single doses taken from multiple repeated doses taken by the individual patient during their period on the study. To obtain steady state PK parameters, individual estimates were simulated from the population model.|up to 276 days|Only participants from Phase II were assessed for this outcome measure. Data was not collected from 4/76 participants.|||L/hr||Full Range|Mean
2805280|NCT00486603|Secondary|Pharmacokinetics (PK) of Hydroxychloroquine as Measured by Lag Time (Tlag)|The population model PK parameters do not specifically represent steady-state values, as they were determined from multiple repeated single doses taken from multiple repeated doses taken by the individual patient during their period on the study. To obtain steady state PK parameters, individual estimates were simulated from the population model.|up to 276 days|Only participants from Phase II were assessed for this outcome measure. Data was not collected from 4/76 participants.|||hour||Full Range|Mean
2805281|NCT00486603|Secondary|Pharmocodynamics as Determined by Number of Participants With Autophagy Inhibition in Relation to Maximal Concentration (Cmax) of HCQ|Autophagy inhibition is represented by an increase in autophagic vacuoles (AV) in participants with at least 2 peripheral blood mononuclear cell samples that were amenable to EM.|up to 9 weeks|Only participants who had at least 2 PBMC samples that were amenable to EM were assessed for this outcome measure|||Participants|||Count of Participants
2805282|NCT00486603|Secondary|Pharmocodynamics as Determined by Number of Participants With Autophagy Inhibition|Number of participants with at least 2 peripheral blood mononuclear cell (PBMC) samples that were amenable to electronmicroscopy (EM) who showed an increase of autophagic vacuoles in cells.|up to 9 weeks|Only 40 participants had at least 2 PBMC samples that were amenable to EM, which was required to assess this outcome measure.|||Participants|||Count of Participants
2805283|NCT00486603|Secondary|(Phase II) Number of Participants With Grade 3 and 4 Toxicity|Number of participants experiencing Grade 3 and 4 toxicity, as defined by CTCAE v3.0, with a possible, probable or definite relationship to HCQ, TMZ or both|up to 2 years|Only participants from Phase II were assessed for this outcome measure.|||Participants|||Count of Participants
2805284|NCT00486603|Primary|(Phase II) Overall Survival|Number of months alive after end of study participation|2 years|Only Phase 2 participants were assessed for this outcome measure.|||months||95% Confidence Interval|Median
2805366|NCT00485732|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7||||Participants|||Count of Participants
2805285|NCT00486603|Primary|(Phase I) Number of Participants Who Experienced Dose Limiting Toxicity (DLT)|Dose limiting toxicity defined as: Any DLT must be a toxicity considered at least possibly related to HCQ. DLTs will include any possibly, probably, or definitely HCQ-related Grade 3 or 4 toxicity. Known or reasonably suspected TMZ hematological toxicities will not be considered dose limiting unless the treating physician considers the toxicity to be exacerbated by HCQ. Nonhematological toxicities: Any Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)|10 weeks|1/7 subjects from the 400mg cohort only received 70% of expected dose, therefore this subject was not used for toxicity analysis|||Participants|||Count of Participants
2805286|NCT00486603|Primary|(Phase I) Maximum Tolerated Dose (MTD) of Hydroxychloroquine (HCQ)|Number of participants who tolerated doses of HCQ without dose limiting toxicity. The highest dose at which participants did not experience dose limiting toxicity was determined as the MTD.|10 weeks|Cohort 200mg - 3 subjects ; cohort 400mg - 7 subjects; 600mg - 3 subjects; 800mg - 3 subjects|||Participants|||Count of Participants
2805287|NCT00486525|Primary|CES-D|"The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||units on a scale||Standard Error|Least Squares Mean
2805288|NCT00486525|Primary|Vitality, SF-36|"The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.~Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||units on a scale||Standard Error|Least Squares Mean
2805289|NCT00486525|Primary|MFSI-SF Fatigue|"The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.~Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||units on a scale||Standard Error|Least Squares Mean
2805290|NCT00486525|Primary|Stimulated ln (IL-1b)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||ln (pg/mL)||Standard Error|Least Squares Mean
2805291|NCT00486525|Primary|Stimulated ln (IL-6)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||ln (pg/mL)||Standard Error|Least Squares Mean
2805292|NCT00486525|Primary|Stimulated ln (TNF-a)|log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.|||ln (pg/mL)||Standard Error|Least Squares Mean
2805293|NCT00486447|Secondary|Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).||1 year outcomes after initial MPS exam|Data were not collected for analysis.||||||
2805294|NCT00486447|Primary|Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.|Number of subjects with CT for detection purposes|through study completion, an expected average of 1 year|Data were not collected for analysis.||||||
2805295|NCT00486434|Secondary|Disease Progression in the Knee Evaluated by MRI.|Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.|From Baseline to Month 24|MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania.|||percentage of change||Standard Deviation|Mean
2805296|NCT00486434|Secondary|Nature and # of AEs Monitored Continuously During Study|Adverse events were by system organ class of all patients.|From Baseline to Month 24|ITT population. A patient with multiple occurrences of a TEAE under one treatment is counted only once in the AE category for that treatment.|||Number of AEs by system organ class|||Number
2805297|NCT00486434|Secondary|Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months|"To assess disease progression of OA affected joints, X-rays of both hands were performed & assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, & joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.~The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated."|Baseline and Month 24|About 15% of the ITT population had hand OA at baseline and only these subjects were included in the X-ray assessments.The AUSCAN questionnaire was administered to all the patients at sites in Denmark, the Czech Republic, and Romania.|||Scores on a scale||Standard Deviation|Mean
2805298|NCT00486434|Secondary|Changes in Biochemical Markers of Bone & Cartilage Metabolism.|The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.|From Baseline to Month 24|ITT Population. The number analyzed in some rows differs from the overall number analyzed due to missing values from patients who prematurely discontinued.|||percentage of change||Standard Deviation|Mean
2805299|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Inter-Quartile Range|Median
2805300|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Inter-Quartile Range|Median
2805301|NCT00486434|Primary|Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||mm||Standard Deviation|Mean
2805302|NCT00486330|Primary|Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)|Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.|10 days||||h*ng/mL||Full Range|Geometric Mean
2805303|NCT00486291|Secondary|Absolute Weight Change (kg) From Baseline to Week 28||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||kg||Standard Error|Least Squares Mean
2805304|NCT00486291|Primary|Change From Baseline in HbA1c at Week 28.||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
2805305|NCT00486278|Secondary|Haematology: Platelet Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||10^9 cells/L||Standard Deviation|Mean
2805306|NCT00486278|Secondary|Haematology: White Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||10^9 cells/L||Standard Deviation|Mean
2805307|NCT00486278|Secondary|Haematology: Packed Cell Volume||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||percentage (%)||Standard Deviation|Mean
2805308|NCT00486278|Secondary|Haematology: Red Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||10^12 cells/L||Standard Deviation|Mean
2805309|NCT00486278|Secondary|Haematology: Haemoglobin||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||g/dL||Standard Deviation|Mean
2805310|NCT00486278|Secondary|Biochemistry: Creatinine||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||micromol/L||Standard Deviation|Mean
2805311|NCT00486278|Secondary|Biochemistry: ALAT (Alanine Aminotransferase)||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||U/L||Standard Deviation|Mean
2805312|NCT00486278|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||participants|||Number
2805313|NCT00486278|Secondary|Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||mL/kg||Full Range|Median
2805314|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||mL/h||Full Range|Median
2805419|NCT00485173|Secondary|Neck Pain Success Rate|Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805317|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
2805318|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
2805319|NCT00486278|Secondary|Number of Subjects With Need for Additional Haemostatic Agents||within 24 hours after successful control of bleeding episode with trial product|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 9 subjects did not contribute to the data.|||participants|||Number
2805320|NCT00486278|Secondary|Cessation of Bleeding: Number of Doses Needed to Control Bleeding||Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 1 subject did not contribute to the data.|||bleeding episodes|||Number
2805321|NCT00486278|Secondary|Activated Partial Thromboplastin Time (aPTT)|The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||Sec||Standard Deviation|Mean
2805322|NCT00486278|Secondary|F1 + 2 (Prothrombin Fragments 1+2)|Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||pmol/L||Standard Deviation|Mean
2805323|NCT00486278|Secondary|Prothrombin Time (PT)|The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||percentage (%)||Standard Deviation|Mean
2805324|NCT00486278|Secondary|Activated Recombinant Human Factor VII Analogue Activity in the Blood||0-24 hours after trial product administration|All randomised patients in top three dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violation of the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set.|||IU/mL||Standard Deviation|Mean
2805325|NCT00486278|Primary|Number of Adverse Events (AEs)|Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2805326|NCT00486265|Secondary|To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs||Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible.|||||||
2805327|NCT00486265|Secondary|To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.|||||||
2805328|NCT00486265|Primary|To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]|Maximum plasma concentration, Cmax|PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.|||||||
2805329|NCT00486265|Primary|To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.|8 of 9 patients in Part B were evaluable for response following a maximum of 2 courses of induction therapy.|||Participants|||Number
2805330|NCT00486265|Primary|To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)|To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)|Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.|||||||
2805346|NCT00486018|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
2805331|NCT00486252|Other Pre-specified|Change in Intraocular Presssure (IOP): Baseline to Month 1|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 1|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.|||mmHg||Standard Deviation|Mean
2805332|NCT00486252|Secondary|Categorized Percentage Change in Intraocular Pressure (IOP)|Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change < 0); Percentage reduction greater than 20% (percentage change < -20).|Month 1, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."|||participants|||Number
2805333|NCT00486252|Secondary|Percentage Change in Intraocular Pressure (IOP)|Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.|Month 1, Month 3|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.|||percentage change in mmHg||Standard Deviation|Mean
2805334|NCT00486252|Primary|Change in Intraocular Pressure (IOP): Baseline to Month 3|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."|||mmHg||Standard Deviation|Mean
2805335|NCT00486226|Secondary|Aneurysm Occlusion|Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)|post procedure to 6 months|no data was available for 21 subjects post-procedure and 26 subjects at 6 months follow-up; either because the investigator didn't submit the images or due to poor quality of the submitted images|||participants|||Number
2805336|NCT00486226|Secondary|Satisfactory Coil Mass Position|Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically|6 months|no data was available for 33 subjects; either because the investigator didn't submit the images or due to poor quality of the submitted images|||participants|||Number
2805337|NCT00486226|Secondary|Device or Procedure Related Adverse Events (AEs)|Incidence of device or procedure related adverse events during the index procedure and till discharge|index procedure to discharge; an average of 3.8 days||||participants|||Number
2805338|NCT00486226|Primary|The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)|Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically|Intra-procedure||||participants||95% Confidence Interval|Number
2805339|NCT00486044|Secondary|Changes in Cognitive Performance|"Change in Hopkins Verbal Learning Test Delayed Recall~The Hopkins Verbal Learning Test Delayed Recall score is the raw number of words recalled at Trial 4, adjusted for years of education and age. This is a 12-item word list test."|Baseline and 9 months|1 participant in simvastatin arm with missing data|||adjusted words recalled||Standard Deviation|Mean
2805340|NCT00486044|Secondary|Change in Inflammatory Markers|Change noted in serum high-sensitivity c-reactive protein|baseline and 9 months|2 participants in the simvastatin arm and 3 participants in the placebo arm had incomplete hs-CRP results|||mg/L||Standard Deviation|Mean
2805341|NCT00486044|Secondary|Changes in Regional Cerebral Blood Flow on MRI|Mean changes noted in posterior cingulate cortex|baseline and 9 months|Number of participants analyzed represent participants in MRI substudy with readable MRI scans at both baseline and 9 months; 24 and 17 readable MRI scans in simvastatin and placebo arms, respectively. Unusable MRI scans resulted from poor quality images due to technical problems.|||mL/100 g/min||Standard Deviation|Mean
2805342|NCT00486044|Primary|Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42||baseline and 9 months|1 participant declined follow up CSF collection in simvastatin arm; CSF could not be accessed at month 9 in 1 participant in placebo arm|||ng/L||Standard Deviation|Mean
2805343|NCT00486031|Secondary|Time to Onset of AEs|Time to onset of adverse events|24 Months|Data were not collected to perform this analysis||||||
2805344|NCT00486031|Primary|Incidence of Treatment Emergent AEs|Incidence of treatment emergent adverse events|24 Months||||participants|||Number
2805345|NCT00486018|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI-VFQ-25 subscale||Standard Deviation|Mean
2805347|NCT00486018|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||μm||Standard Deviation|Mean
2805349|NCT00486018|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|"BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than the percentage of subjects who gained >=15 letters as losing <15 letters includes both those who gained >=15 letters and those who were stable (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters)."|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2805350|NCT00486018|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2805351|NCT00486018|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.|||Units on a scale||Standard Deviation|Mean
2805352|NCT00485953|Secondary|Markers of Bone Resorption and Bone Formation||at 24 months||||percentage change||Standard Error|Mean
2805353|NCT00485953|Secondary|BMD by DXA at the Femoral Neck and Total Hip|BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.|at 24 months||||percentage change||Standard Error|Mean
2805354|NCT00485953|Primary|BMD of Spine by DXA|BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.|at 24 months||||percentage change||Standard Error|Mean
2805355|NCT00485836|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
2805356|NCT00485836|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.|||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
2805357|NCT00485836|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||μm||Standard Deviation|Mean
2805358|NCT00485836|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2805359|NCT00485836|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2805360|NCT00485836|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
2805361|NCT00485836|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.|||Units on a scale||Standard Deviation|Mean
2805362|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo|after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement|||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Median
2805363|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set|||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
2805364|NCT00485758|Primary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set|||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
2805365|NCT00485732|Secondary|Number of Subjects With Pregnancies and Their Outcome|Total: the total number of pregnancies in a group. The specific outcomes are also listed.|from Day 0 up to Month 7|Analysis was performed on subjects with a pregnancy.|||Participants|||Count of Participants
2805367|NCT00485732|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.|From Day 0 up to Month 7||||Participants|||Count of Participants
2805368|NCT00485732|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination||||Participants|||Count of Participants
2805369|NCT00485732|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||Participants|||Count of Participants
2805370|NCT00485732|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||Participants|||Count of Participants
2805371|NCT00485732|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres|Titres are given as geometric mean titres (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.|||titre||95% Confidence Interval|Geometric Mean
2805372|NCT00485732|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
2805373|NCT00485693|Secondary|Number of Participants With Adverse Events or Serious Adverse Events Through 30 Days||Up to 30 days|||||||
2805374|NCT00485693|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4|"The subject's pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"|0 to 96 hours||||Units on a scale*hours||Standard Deviation|Mean
2805375|NCT00485485|Primary|Participant Response Rate|Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.|At 6 weeks reconfirmed 6 weeks later||||Participants|||Number
2805376|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).|Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.|||Unit on a scale||Standard Deviation|Mean
2805377|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep.|Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.|||Unit on a scale||Standard Deviation|Mean
2805378|NCT00485472|Secondary|Amount of Rescue Medication Use During 8 Week Maintenance Period.|Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.|during 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects who entered the Maintenance Phase were included.|||tablets/day||Standard Deviation|Mean
2805379|NCT00485472|Secondary|Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).|Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Dropouts due to lack of efficay were defined as non-responders. For dropouts due to any other reason LOCF was applied to the underlying WOMAC subscale scores.|||participants|||Number
2805380|NCT00485472|Secondary|Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.|Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.|at the end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing measurements of Patient's global impression of change from baseline were included.|||Participants|||Number
2805381|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.|The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
2805382|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.|The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
2805383|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.|The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
2805384|NCT00485472|Primary|Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period|The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Last observation carried forward (LOCF) imputation method was applied in case of missing WOMAC assessment.|||Unit on a scale||Standard Deviation|Mean
2805385|NCT00485433|Secondary|Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days||Up to 30 days|||||||
2805386|NCT00485433|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours|"The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"|0 to 72 hours||||Units on a scale*hours||Standard Deviation|Mean
2805387|NCT00485303|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||percentage of participants|||Number
2805388|NCT00485303|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.|||participants|||Number
2805389|NCT00485303|Secondary|Time to Radiographic Progression|Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
2805390|NCT00485303|Secondary|Time to PSA Progression|The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.|Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
2805391|NCT00485303|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. “N” (number of participants analyzed) =participants who were evaluable for this measure.|||percentage of participants|||Number
2805392|NCT00485303|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Every 3 months until death or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
2805393|NCT00485303|Secondary|Radiographic Progression Free Survival (PFS)|The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months||||days||95% Confidence Interval|Median
2805394|NCT00485303|Secondary|Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)|The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||days||95% Confidence Interval|Median
2805395|NCT00485303|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Day 1 of each cycle (of 28 days each) up to Cycle 12|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.|||percentage of participants||95% Confidence Interval|Number
2805396|NCT00485264|Secondary|Change of CD4 Percent From Baseline|Change in CD4 percent from baseline was calculated as the value of the later visit minus the value at baseline.|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of total lymphocytes||95% Confidence Interval|Mean
2805397|NCT00485264|Secondary|Change of CD4 Count From Baseline|Change in CD4 cell count from baseline was calculated as the value at later visit minus the value at baseline.|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||cells/µL||95% Confidence Interval|Mean
2805398|NCT00485264|Secondary|Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL|Plasma HIV RNA concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular), and analyses used the Observed Failure Approach.|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of participants||95% Confidence Interval|Number
2805399|NCT00485264|Secondary|Number of Participants Who Died|Number of participants who died were summarized.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
2805400|NCT00485264|Secondary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
2805401|NCT00485264|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of participants||95% Confidence Interval|Number
2805402|NCT00485264|Primary|PK Parameter: Concentration at 12 Hours Postdose (C12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Plasma concentration at 12 hours postdose (C12h) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||ng/mL||Standard Deviation|Mean
2817982|NCT00396981|Secondary|Neurological Assessments|"The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects same or better."|12 months||||percentage of participants|||Number
2805403|NCT00485264|Primary|PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Time to half of maximum plasma concentration Cmax (T1/2) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||hour||Standard Deviation|Mean
2805404|NCT00485264|Primary|PK Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Maximum plasma concentration (Cmax) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||ng/mL||Standard Deviation|Mean
2805405|NCT00485264|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I).|||hour*mg/L||Standard Deviation|Mean
2805406|NCT00485264|Primary|Number of Participants Who Died|Number of participants who died were summarized.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
2805407|NCT00485264|Primary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||participants|||Number
2805408|NCT00485264|Primary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts were combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.|||percentage of participants||95% Confidence Interval|Number
2805409|NCT00485173|Other Pre-specified|Ossification in the Region of Target Level|Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805410|NCT00485173|Secondary|Number of Patients Who Had Secondary Surgeries at the Index Level|Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.|24 months post-operation||||participants|||Number
2805411|NCT00485173|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|Primary dataset.|||days||Standard Deviation|Mean
2805412|NCT00485173|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|Primary dataset.|||ml||Standard Deviation|Mean
2805413|NCT00485173|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|Primary dataset.|||hrs||Standard Deviation|Mean
2805414|NCT00485173|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805415|NCT00485173|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805416|NCT00485173|Other Pre-specified|General Health Status -- SF-36 MCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
2805417|NCT00485173|Secondary|Arm Pain Success Rate|Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805418|NCT00485173|Other Pre-specified|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
2805420|NCT00485173|Other Pre-specified|Arm Pain Score|"Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score will be the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
2805421|NCT00485173|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805422|NCT00485173|Other Pre-specified|Neck Pain Score|"Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score is the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
2805423|NCT00485173|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805424|NCT00485173|Other Pre-specified|Neck Disability Index Score|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 months post-operation|Primary dataset.|||units on a scale||Standard Deviation|Mean
2805425|NCT00485173|Secondary|Success Rate of Fusion|"Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:~Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.~No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.~No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs)."|24 months post-operation|Primary dataset.|||percentage of participants|||Number
2805426|NCT00485173|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~fusion at the treated level;~pain/disability (Neck Disability Index) success;~neurological status success;~no serious adverse event classified as implant associated or implant/surgical procedure associated;~no additional surgical procedure classified as a failure."|24 months post-operation|Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)|||percentage of participants|||Number
2805427|NCT00485134|Secondary|Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS|Immune responder is defined as someone with both a serologic and an ASC response to either Invaplex 50 or LPS. Immune response defined as Serology: ≥ 4-fold increase in baseline serum titer antibody cecreting cells (ASC): ≥ 10 ASC per 106 peripheral blood mononuclear cells(PBMC).|56 days post-vaccination in stage 1|This analysis is limited to groups A-C only and subjects receiving at least 2 doses of S. flexneri 2a Invaplex 50 or LPS|||participants|||Number
2805428|NCT00485134|Secondary|S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group||56 days post-challenge||||participants|||Number
2805429|NCT00485134|Secondary|Post-challenge Loose Stool Sample Durations by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.|||hours||Full Range|Mean
2805430|NCT00485134|Secondary|Post-challenge Loose Stool Sample Volumes by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.|||mL||Full Range|Mean
2805431|NCT00485134|Secondary|Post-challenge Loose Stool Samples Occurrences by Study Group||7 days after challenge|One subject in each group had diarrhea continuing at discharge so measured stool output likely an underestimate.|||loose stools||Full Range|Mean
2805432|NCT00485134|Primary|Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group|Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).|7 days after challenge|The decision criteria to progress to challenge with the Shigella challenge strain were no limiting adverse events (AEs) and positive immune response. These individuals were challenged with 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T.|||participants|||Number
2805433|NCT00485069|Secondary|"Mean Change From Baseline in Awake Time Off (Hours) and Awake Time On (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With 0 Off (Hour) at Baseline"|"Off state is where PD symptoms are not adequately controlled by the drug. On state is where PD symptoms are well controlled by the drug. The off's duration (awake time spent off) and the on's duration (awake time spent on) on each day were calculated."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants having off hour of zero at baseline were not included at FAP. These participants as well as those prematurely withdrawn from the study were not included at Week 52."|||hours||Standard Deviation|Mean
2805434|NCT00485069|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP|"CGI is measured on the following 7-point scale: 1, Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; and 7, Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Week 52 and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||participants|||Number
2805436|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-422|FAS|||percentage of participants|||Number
2805437|NCT00485069|Secondary|Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||percent change||Standard Deviation|Mean
2805438|NCT00485069|Secondary|"Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline in off state, or having no data in the corresponding state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."|||percent change||Standard Deviation|Mean
2805439|NCT00485069|Secondary|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided.|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||participants|||Number
2805440|NCT00485069|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. LOCF was used for the FAP data to impute post-baseline missing values. Some participants in each state were not included at FAP as having no post-baseline data in the corresponding state or having no data in the corresponding state at Week 52/withdrawal.|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."|||participants|||Number
2805441|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn from the study were not included at Week 52.|||percent change in score||Standard Deviation|Mean
2805442|NCT00485069|Secondary|Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
2805443|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 in that group and those prematurely withdrawn in each group were not included at Week 52."|||percent change in score||Standard Deviation|Mean
2805452|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||units on a scale||Standard Deviation|Mean
2805444|NCT00485069|Secondary|"Japanese UPDRS Part III Mean Total Score (in On State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants having off state at baseline were not included in the ROP+L-dopa group at baseline. The participant not included in the FAP as well as one having off state in the ROP+L-dopa group at Week 52 and those prematurely withdrawn in each group were not included at Week 52."|||units on a scale||Standard Deviation|Mean
2805445|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change. These participants as well as those prematurely withdrawn were not included at Week 52|||percent change in score||Standard Deviation|Mean
2805446|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for FAP data. Some participants were not included at FAP as having a baseline value of zero, having no post-baseline data in on state, not having off state at baseline in off state, or having no data at Week 52/withdrawal in off state. These participants as well as those prematurely withdrawn were not included at Week 52."|||percent change in score||Standard Deviation|Mean
2805447|NCT00485069|Secondary|Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.|||units on a scale||Standard Deviation|Mean
2805448|NCT00485069|Secondary|"Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state or having no data in off state at Week 52/withdrawal."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."|||units on a scale||Standard Deviation|Mean
2805449|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn in each group were not included at Week 52.|||percent change in score||Standard Deviation|Mean
2805450|NCT00485069|Secondary|Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
2805451|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
2807224|NCT00469833|Secondary|HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Type 2 diabetic subjects had HbA1c measured before and after 2 months of basal insulin glargine treatment.|2 months||||% glycosylated hemoglobin||Standard Error|Mean
2805453|NCT00485069|Secondary|"Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline, or no data in off state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."|||units on a scale||Standard Deviation|Mean
2805454|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.|||units on a scale||Standard Deviation|Mean
2805455|NCT00485069|Primary|"Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)"|"The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 and those prematurely withdrawn were not included at Week 52."|Baseline, Week 52, and FAP (up to Week 52)|Full Analysis Set (FAS): all participants enrolled in the Treatment Phase, excluding those with objective measurements not meeting the major eligibility criteria, who did not receive ROP at all, and those with no valid post-baseline data. Last observation carried forward (LOCF) was used for the FAP data to impute post-baseline missing values.|||units on a scale||Standard Deviation|Mean
2805456|NCT00484939|Secondary|AEs, Laboratory Parameters, Vital Signs||Throughout study|||||||
2805457|NCT00484939|Secondary|Duration of Follow-up|Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Days||Standard Deviation|Mean
2805458|NCT00484939|Secondary|Percentage of Participants Requiring Additional Treatment for Malignancy|Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Percentage of participants|||Number
2805459|NCT00484939|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.|Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).|Intent-to-treat population: All participants randomized into the study.|||Percentage of participants|||Number
2805460|NCT00484939|Secondary|Overall Survival|Overall survival was defined as the time in months from randomization to death from any cause.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Months||95% Confidence Interval|Median
2805461|NCT00484939|Secondary|Time to Response|Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Months||95% Confidence Interval|Median
2805462|NCT00484939|Secondary|Duration of Response|Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis.|||Months||95% Confidence Interval|Median
2805477|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16|mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||Standard Deviation|Mean
2805463|NCT00484939|Secondary|Best Overall Response (BOR)|BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2805464|NCT00484939|Primary|Progression-free Survival|Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.|||Months||95% Confidence Interval|Median
2805465|NCT00484874|Secondary|Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose|Percentage of participants with visualized I-131 uptake.|up to 1 week post-intervention||||Percentage of patients with I-131 uptake|||Number
2805466|NCT00484874|Secondary|Median Time to Progression Following I-131 Tositumomab Therapy.||From time measurement criteria are met for response until first date that recurrent or progressive disease is objectively documented, assessed up to 5 years.||||weeks||Standard Deviation|Median
2805467|NCT00484874|Primary|Overall and Complete Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CTI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|12 weeks post therapy||||percentage of participants|||Number
2805468|NCT00484874|Primary|Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma.||2 years||||cGy|||Number
2805469|NCT00484679|Primary|Mean Change in Cortisol Levels From Baseline to Week 24|Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.|baseline, week 24|Participants who completed all treatment and follow-up visits|||mg/dL||Standard Deviation|Mean
2805470|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)|percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change in LDL-C||95% Confidence Interval|Least Squares Mean
2805471|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16|mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change in LDL-C||Standard Deviation|Mean
2805472|NCT00484419|Secondary|Mean Change in LDL-C From Week 0(Baseline) to Week 16|mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
2805473|NCT00484419|Secondary|Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean|change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2805474|NCT00484419|Secondary|Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16|mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
2805475|NCT00484419|Secondary|Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16|mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
2805476|NCT00484419|Secondary|Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean|change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2807237|NCT00469391|Primary|Percent Excess Weight Loss (%EWL) at Week 12|Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)|3 months||||Percentage of Excess Weight Loss||Standard Deviation|Mean
2805478|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8|mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||Standard Deviation|Mean
2805479|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||95% Confidence Interval|Least Squares Mean
2805480|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||uIU/mL||95% Confidence Interval|Least Squares Mean
2805481|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 16|change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||Standard Deviation|Mean
2805482|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 8|mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.||||mg/dL||Standard Deviation|Mean
2805483|NCT00484419|Secondary|Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean|change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2805484|NCT00484419|Secondary|Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean|change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2805485|NCT00484419|Primary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint|Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change HbA1c||Standard Deviation|Mean
2805486|NCT00484419|Secondary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8|change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.||||% change in HbA1c||Standard Deviation|Mean
2805487|NCT00484419|Secondary|Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean|Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.|||% change in HbA1c||95% Confidence Interval|Least Squares Mean
2805488|NCT00484393|Primary|To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.|Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score|2 visits, 1 month apart|Each participant was evaluated for repsonse following tetracaine and following placebo|||units on a scale||Full Range|Mean
2805489|NCT00484354|Secondary|Mortality|Number of patients who died during the hospitalization|Until hospital discharge, up to 30 days||||Participants|||Count of Participants
2805490|NCT00484354|Secondary|Number of Participants With Need for Dialysis|Number of participants needing dialysis|Until hospital discharge, up to 30 days||||Participants|||Count of Participants
2805491|NCT00484354|Secondary|Length of Hospital Stay|Length of hospital stay in days|Until hospital discharge, up to 30 days||||days||Standard Deviation|Mean
2805492|NCT00484354|Secondary|Change in GFR Over 72 Hours Post Operatively|25% or greater change in serum creatinine level|72 hours||||Participants|||Count of Participants
2805493|NCT00484354|Primary|Number of Participants Who Developed Acute Kidney Injury Within 72 Hours|Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline|72 hours post-operative||||Participants|||Count of Participants
2805494|NCT00484315|Secondary|In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure|"The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment (in-segment) is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent."|9 months post-index procedure|All patients from the per protocol analysis set who were randomized to the angiographic subset and completed their angiographic follow-up were analyzed for the secondary endpoint.|||percent diameter stenosis||Standard Deviation|Mean
2805539|NCT00484094|Secondary|Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula|Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set.|||mL/min||Full Range|Median
2817983|NCT00396981|Secondary|Angiographic Assessments|"Number of participants with angiographic assessment of complete obliteration."|Reintervention or 12 months||||participants|||Number
2805495|NCT00484315|Primary|Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per protocol analysis set. All randomized participants who had the randomly assigned study stent implanted in the target coronary artery are included.|||participants|||Number
2805496|NCT00484289|Primary|Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator||At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.|||participants|||Number
2805497|NCT00484289|Secondary|Abatacept PK Parameter: Minimum Plasma Concentration at Steady State|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||µg/mL||Full Range|Median
2805498|NCT00484289|Secondary|Abatacept PK Parameter: Maximum Serum Concentration at Steady State|Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||µg/mL||Full Range|Median
2805499|NCT00484289|Secondary|Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State|Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||µg*h/mL||Full Range|Median
2805500|NCT00484289|Secondary|Abatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.|||L/day||Full Range|Median
2805501|NCT00484289|Secondary|Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies|Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.|At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.|All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.|||participants|||Number
2805502|NCT00484289|Secondary|Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||IU/mL||95% Confidence Interval|Mean
2805503|NCT00484289|Secondary|Baseline and Postbaseline Rheumatoid Factor Levels|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||IU/mL||Standard Deviation|Mean
2805504|NCT00484289|Secondary|Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||percentage improvement||95% Confidence Interval|Mean
2805505|NCT00484289|Secondary|Baseline and Postbaseline C-reactive Protein (CRP) Levels|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point.|||mg/dL||Standard Deviation|Mean
2805515|NCT00484289|Secondary|Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||Units on a Scale||95% Confidence Interval|Mean
2805506|NCT00484289|Secondary|Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.|At BL (Week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||95% Confidence Interval|Mean
2805507|NCT00484289|Secondary|Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||Standard Deviation|Mean
2805508|NCT00484289|Secondary|Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.|At baseline (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||95% Confidence Interval|Mean
2805509|NCT00484289|Secondary|Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.|||Units on a Scale||Standard Deviation|Mean
2805510|NCT00484289|Secondary|Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||percentage of participants||95% Confidence Interval|Number
2805511|NCT00484289|Secondary|Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.~Participants with DAS 28 score < 2.6 were considered to be in remission."|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.|||participants|||Number
2805512|NCT00484289|Secondary|Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.|||participants|||Number
2805513|NCT00484289|Primary|Number of Participants With Abnormal Laboratory Changes (ALC)|The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.|||participants|||Number
2805514|NCT00484289|Secondary|Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.~Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement."|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||participants|||Number
2805516|NCT00484289|Secondary|Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data.|At BL (week 0), week 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.|||Units on a Scale||Standard Deviation|Mean
2805517|NCT00484289|Secondary|Percentage of Participants With ACR 70 Response Over Time|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.|||percentage of participants||95% Confidence Interval|Number
2805518|NCT00484289|Secondary|Percentage of Participants With ACR 50 Response Over Time|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.|||percentage of participants||95% Confidence Interval|Number
2805519|NCT00484289|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.|||percentage of participants||95% Confidence Interval|Number
2805520|NCT00484289|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.|||participants|||Number
2805521|NCT00484185|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who discontinued the study due to AEs was reported.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
2805522|NCT00484185|Other Pre-specified|Duration of Adverse Events (AEs)|Total time from onset of adverse event till the event is resolved. Duration of AE per event = AE stop date minus AE start date plus 1.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2805523|NCT00484185|Secondary|Percentage of Participants With Efficacy Evaluation|The efficacy of study drug was rated as 'very effective', 'effective', 'slightly ineffective' and 'ineffective'.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2805524|NCT00484185|Secondary|Total Infusion of Study Medication|Total dose of study drug infused was calculated over the study duration.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once.|||IU||Standard Deviation|Mean
2805525|NCT00484185|Secondary|Average Infusion Dose of Study Medication|Average of dose per infusion per kilogram (kg) body weight was reported for prophylaxis purpose or on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed)= participants evaluable for this measure and 'n' = participants evaluable for the specified category.|||international unit/kilogram (IU/kg)||Standard Deviation|Mean
2805526|NCT00484185|Secondary|Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication|Mean frequency of breakthrough (spontaneous/non-traumatic) bleeds of each participant within 48 hours of a preventive/prophylaxis dose of BeneFIX was calculated from number of irregular bleeding which occurred in each participant. Mean frequency breakthrough bleeds for total participants within 48 hours of a preventive/prophylaxis dose of BeneFIX was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||breakthrough bleeds||Standard Deviation|Mean
2805537|NCT00484159|Secondary|Successful Treatment|Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.|3-months postprocedure||||participants|||Number
2805527|NCT00484185|Secondary|Mean Number of Infusion of Study Medication|Mean frequency of BeneFIX administration of each participant was calculated from number of BeneFIX infusions which each participant received for treatment of each new bleed. Mean frequency of BeneFIX administration for total participants was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||infusions||Standard Deviation|Mean
2805528|NCT00484185|Secondary|Number of Responses to On-demand Treatment With Study Medication|Responses to on-demand treatment were rated by participant/caregiver or physician each time the drug was administered, on 4-point scale. Score 1=excellent (definite pain relief [PR] and improvement [imp] within 8 hours [h] of infusion [inf], no additional inf); score 2=good (definite PR and imp within 8h of inf, at least 1 additional inf for complete resolution [CR] of bleeding or starting after 8h of inf, no additional inf); score 3=moderate (probable or slight imp starting after 8h of inf, at least 1 additional inf for CR of bleeding); score 4=no imp at all, or condition worsens).|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||responses|||Number
2805529|NCT00484185|Secondary|Mean Annualized Bleeding Rate (ABR)|An annualized bleeding rate (ABR) was calculated as the number of bleeds requiring administration of BeneFIX (for on-demand therapy and surgery), divided by total period of bleeding multiplied by 365.25. Total period of bleeding is the number of days on treatment for prophylaxis purpose and on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||bleeds per year||Standard Deviation|Mean
2805530|NCT00484185|Primary|Number of Participants With Unexpected Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Unexpected AEs were those that were not included in precaution of local product document.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
2805531|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) by Relationship|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. All causalities and drug-related AEs reported. Drug-related AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
2805532|NCT00484185|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed based on response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2805533|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Seriousness|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
2805534|NCT00484185|Primary|Number of Participants With Action Taken in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. After an onset of an AE, relevant actions were undertaken on the study drug or the participant. Actions related to study drug included: dosage reduced, dosage increased, stopped temporarily or permanently, no action taken; actions related to participants included: withdrawal from the study, concomitant medication, no action taken or any other as per physician's discretion.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
2805535|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. Same participant may be represented in more than 1 category.|||participants|||Number
2805536|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Baseline Characteristics|AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AE assessed by baseline characteristics (chr) included age, gender, pediatric/geriatric status, liver disorder, BeneFIX treatment (previously/newly), factor nine (FIX) gene mutation, prior exposure to plasma-derived FIX products, prior FIX regimen(s) utilized, personal history of FIX inhibitor, family history of hemophilia B, severity of bleeding, medical history, concomitant medication and therapy.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.|||participants|||Number
2805540|NCT00484094|Secondary|Percentage of Participants With Survived Graft|Graft survival was defined as not showing graft loss at the time of evaluation.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.|||Percentage of participants||95% Confidence Interval|Number
2805541|NCT00484094|Secondary|Percentage of Participants Alive|The investigator recorded the participant's survival status and evaluation date on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.|||Percentage of participants||95% Confidence Interval|Number
2805542|NCT00484094|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies|Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.|||Percentage of participants||95% Confidence Interval|Number
2805543|NCT00484094|Primary|Percentage of Participants With Clinically Significent Abnormal Laboratory Test|Laboratory test was not mandatory because this study was a non-interventional study.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|This analysis was not performed because laboratory data were not collected during the study.||||||
2805544|NCT00484094|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|"All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer."|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|Safety Analysis Set|||Percentage of participants|||Number
2805545|NCT00483938|Secondary|Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)|"End of treatment response (ETR) was defined as Success if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as Success, if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as Success, if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point."|Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)|ITT population|||percentage of participants|||Number
2805546|NCT00483938|Secondary|Percentage of Participants With SVR (Groups C, D, E, and F)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.|At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)|ITT. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2805547|NCT00483938|Primary|Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.|At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)|Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2805548|NCT00483756|Secondary|Severity of Dyspepsia Assessment (SODA)|SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal [Ab] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).|Baseline, Month 6, 12|Data not analyzed since the SODA instrument was found irrelevant in the treated population.||||||
2805549|NCT00483756|Secondary|End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)|"ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated questionAt the moment,how much do you suffer?for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction."|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.|||units on a scale||Standard Deviation|Mean
2805550|NCT00483756|Secondary|36-Item Short-Form Health Survey (SF-36)|"SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 how would you rate your health in general now?(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.|||units on a scale||Standard Deviation|Mean
2805551|NCT00483756|Secondary|Number of Participants With Clinically Significant Infections|Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.|Baseline up to Month 12|FAS: all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2805552|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 * (serum creatinine)^(-1.154) * (age in years)^(-0.203) * (0.742 if female) * (1.210 if black). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.|||mL/min per 1.73 m^2||Standard Deviation|Mean
2805553|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine)^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration)^(-0.170) * (serum albumin concentration)^(0.318).A normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.|||mL/min/1.73 m^2||Standard Deviation|Mean
2805554|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.|||mL/min||Standard Deviation|Mean
2805555|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Nankivell Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF).|||mL/min||Standard Deviation|Mean
2805556|NCT00483756|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants|||||||
2805557|NCT00483756|Secondary|Lymphocyte Subset|The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.|Month 1, 3, 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.|||cells per microliter||Standard Deviation|Mean
2805558|NCT00483756|Secondary|Number of Participants Who Died||Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
2805559|NCT00483756|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
2805560|NCT00483756|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for >=6 consecutive weeks.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
2805561|NCT00483756|Secondary|Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)|Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively.|||participants|||Number
2805562|NCT00483756|Secondary|Number of Participants With Treated Clinical Acute Rejection|Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.|||participants|||Number
2805563|NCT00483756|Secondary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 mg/dL and >=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.|Baseline up to Month 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.|||participants|||Number
2805564|NCT00483756|Secondary|Number of Participants With Progression of Chronic Allograft Lesions at Month 12|Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.|Month 12|Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12.|||participants|||Number
2805565|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) at Month 6|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6.|||mL/min||Standard Deviation|Mean
2805566|NCT00483756|Primary|Glomerular Filtration Rate (GFR) at Month 12|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12.|||mL/min||Standard Deviation|Mean
2805567|NCT00483756|Primary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 milligram per deciliter (mg/dL) and >=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.|Baseline up to Month 6|Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.|||participants|||Number
2805568|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|48 hours post-dosing|Modified ITT|||participants|||Number
2805569|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|24 hours post-dosing|Modified ITT|||participants|||Number
2805574|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|0.5 hours post-dosing|Modified ITT|||participants|||Number
2805575|NCT00483717|Primary|The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|2 hours after dosing|Modified ITT|||participants|||Number
2805576|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 24 hours.|||Percentage of participants|||Number
2805577|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)|TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants|||Number
2805578|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.|From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 48 hrs, or a recurrence question.|||Percentage of participants|||Number
2805579|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.|||Percentage of participants|||Number
2805580|NCT00483704|Primary|Number of Participants Discontinuing Study Medication Due to an AE|Participants discontinuing study medication due to an AE were reported for all migraine attacks.|Up to the 4th dose of study medication (up to 6 months)|The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.|||Participants|||Number
2805581|NCT00483704|Primary|Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)|AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.|Up to 48 hours post-dose for the first migraine attack (up to 6 months)|The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group.|||Participants|||Number
2805582|NCT00483704|Primary|Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.|||Percentage of participants|||Number
2805583|NCT00483704|Primary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.|||Percentage of participants|||Number
2805640|NCT00483327|Secondary|Toxicity and Tolerability|Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment. AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3.|up to 36 months|Any patient with at least one dose of treatment.|||participants|||Number
2805584|NCT00483704|Primary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.|||Percentage of participants|||Number
2805585|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose|Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.|2 hours post-dose (up to 6 months)|The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.|||Percentage of participants|||Number
2805586|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose|Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.|2 hours post-dose (up to 6 months)|The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.|||Percentage of participants|||Number
2805587|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants|||Number
2805588|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)|Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.|||Percentage of participants|||Number
2805589|NCT00483652|Secondary|Change in Lower Extremity Manual Muscle Test [LEMMT]|Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77||||units on a scale||Standard Deviation|Mean
2805590|NCT00483652|Primary|Responders Based Upon the Timed 25-Foot Walk [T25FW]|A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77|Modified Intention-to-Treat [ITT] population|||participants|||Number
2805591|NCT00483574|Other Pre-specified|Safety Overview After Any Vaccination in Participants Who Received MMR+V||Day 0 to 7 Post-vaccination|Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.|||Percentage of participants|||Number
2805592|NCT00483574|Primary|Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.|"Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.~Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability"|Day 0 to 7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.|||Percentage of participants|||Number
2805593|NCT00483561|Secondary|Biomarkers||At every cycle|Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.||||||
2805594|NCT00483561|Primary|Overall Response Rate as Measured by RECIST Criteria and PSA Criteria|If there is at least 1 response, then 7 additional patients will be enrolled. If there are 4 or more responders overall, then the combination will be considered active and warrant further study. Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy.|Approximately 3 years|Fifteen subjects were evaluable. A total of 26 subjects were consented; two were screen failures. Nine subjects were not evaluable due to coming off study prior to reaching the point of evaluation (2 cycles).|||Participants|||Count of Participants
2808361|NCT00462722|Secondary|Bone Turnover Markers||Baseline, and after 4.5 & 9 months of training|Because of the costs associated with the assays and data analysis of bone turnover markers, we did not pursue data collection after learning of the primary outcomes (changes in BMD).||||||
2805595|NCT00483548|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6|Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805596|NCT00483548|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores|AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805597|NCT00483548|Other Pre-specified|Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)|BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values.|Baseline, Week 2, Week 4, Week 6|ITT; Summarized as Global BARS; individual scores not summarized; (n)=number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805598|NCT00483548|Other Pre-specified|Change From Baseline in Simpson Angus Scale (SAS) Score|SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805599|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||days||Standard Deviation|Mean
2805600|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805601|NCT00483548|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6|GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values.|Baseline, Week 6|ITT; observed cases; Early Termination (ET) visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805602|NCT00483548|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805660|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2805603|NCT00483548|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint.|Baseline, Week 2, Week 4, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805604|NCT00483548|Secondary|CGI-Improvement Score|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805605|NCT00483548|Secondary|Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805606|NCT00483548|Secondary|Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.|||scores on scale||Standard Deviation|Mean
2805607|NCT00483548|Secondary|Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6|Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected.|Baseline, Week 6|ITT; LOCF|||participants|||Number
2805608|NCT00483548|Secondary|MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6|Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value.|Week 6|ITT; LOCF|||participants|||Number
2805609|NCT00483548|Secondary|MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6|Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms).|Week 6|ITT; Last observation carried forward (LOCF)|||participants|||Number
2805610|NCT00483548|Secondary|Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 6|ITT|||scores on scale||Standard Deviation|Mean
2805611|NCT00483548|Primary|Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 6|Intent to Treat analysis set (ITT): all randomized subjects who received at least 1 dose of double-blind treatment and had at least 1 post-baseline primary efficacy evaluation.|||scores on scale||Standard Deviation|Mean
2805612|NCT00483509|Secondary|Number of Adverse Events, Reported by Severity and Relation to Treatment|Evaluation according to NCI common terminology criteria for adverse events (version 3.0)|Through study completion, an average of 3 years||||Event|||Number
2805613|NCT00483509|Secondary|Experimental Imaging Study (DCE-MRI)|To document possible modifications on vessels permeability by imaging techniques|during the study|Though a DCE-MRI evaluation was planned by protocol for a selected number of patients, no DCE-MRI assessments were performed.||||||
2805614|NCT00483509|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from the baseline CT scan to death due to any cause, or the last date the patient was known to be alive.|Through study completion, an average of 3 years||||months||95% Confidence Interval|Median
2805615|NCT00483509|Secondary|Tumor Growth Control Rate (TGCR)|"evaluated according to Response evaluation criteria in solid tumors (RECIST V1.0) for target lesions and assessed by MRI:~Complete Response (CR):Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the base line sum LD~Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|Assessed every 6-12 weeks, up to 150 weeks||||Participants|||Count of Participants
2805616|NCT00483509|Primary|Antitumour Activity Defined as Progression Free Survival (PFS)|Defined as the time from the date of randomization until disease progression, or death due to any cause or the last patient was known to be alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition the appearance of one or more new lesions was also considered progression|From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks||||months||95% Confidence Interval|Median
2805617|NCT00483496|Secondary|Adverse Events||through study completion||||Participants|||Count of Participants
2805618|NCT00483496|Primary|Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products|"MUD was defined as the minimal dose for occurrence of objective signs of SU (wheal, flare) under exposure to the solar simulator. Results are expressed as photodermatosis protection factor (PPF), calculated by dividing the MUD of protected skin (sessions 2 to 5) by the MUD of the unprotected skin (session 1) in each treatment group.~Procedure: At baseline, 4 grids of 8 adjacent test areas on the patient back were defined. The defined test areas of each grid were applied with the respective test products by the investigating staff at the beginning of each session, according to a predefined randomisation schedule. Grids were sequentially irradiated one by one with 1 MUD (session 2) , 3 MUD (session 3) , 5 MUD (session 4), and 7 MUD (session 5), respectively. After product removal at each session, patients were observed for 30 min for the development of SU lesions. Final reading of all areas was performed at the end of each session, by the investigator masked to product site assignment."|During each one of the 5 sessions, at study day||||Photodermatosis Protection Factor||Full Range|Mean
2805619|NCT00483405|Secondary|Time to Progression|Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median 23 month follow-up|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.|||months||95% Confidence Interval|Median
2805620|NCT00483405|Secondary|Overall Survival|Overall survival will be calculated from time of enrollment to death or last contact date.|Median 23 month follow-up|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.|||months||95% Confidence Interval|Median
2805621|NCT00483405|Secondary|Number of Subjects Experiencing Adverse Events|Adverse events will be assessed using CTCAE criteria.|every 3 weeks of treatment with an average of 15 weeks on treatment||||Participants|||Count of Participants
2805622|NCT00483405|Primary|Disease Response Rate|"Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions."|42 days (2 cycles)|Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.|||percentage of participants with response||95% Confidence Interval|Number
2805623|NCT00483379|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events During the Treatment Period|Overall safety summary of participants experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment.|Day 1 up to Week 52|Safety population comprised of all participants who received intervention.|||participants|||Number
2805624|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Motor Function Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; motor function decline primarily based on Gross Motor Function Measure 66 and Pompe Pediatric Evaluation of Disability Inventory results is summarized. Participants could gain motor function (improve), had no change (declined stopped), or continued loss (worsened). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in motor function while on standard treatment.|||participants|||Number
2805625|NCT00483379|Secondary|Change From Baseline in Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36) at Week 52|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Baseline, Week 52|Full analysis population of participants >= 14 years old.|||units on a scale||Standard Deviation|Mean
2805626|NCT00483379|Secondary|Baseline Values for Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36)|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Day 0|Full analysis population of participants >= 14 years old.|||units on a scale||Standard Deviation|Mean
2805627|NCT00483379|Secondary|Change From Baseline in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at Week 52|"The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Change from baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near 0 reflecting low capability and scores near 100 reflecting high capability."|Baseline, Week 52|Full analysis population|||units on a scale||Standard Deviation|Mean
2805628|NCT00483379|Secondary|Baseline Values in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI)|"The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near 0 reflecting low capability and scores near 100 reflecting high capability."|Day 0|Full analysis population|||units on a scale||Standard Deviation|Mean
2805629|NCT00483379|Secondary|Change From Baseline in Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results at Week 52|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Baseline, Week 52|Full analysis population|||units on a scale||Standard Deviation|Mean
2805630|NCT00483379|Secondary|Baseline Values of Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Day 0|Full analysis population|||units on a scale||Standard Deviation|Mean
2805631|NCT00483379|Secondary|Change From Baseline in Body Strength Measured by the Manual Muscle Testing (MMT) Total Score at Week 52|Body strength is measured by the MMT score on a scale of 0-10 with higher scores representing greater body strength.|Baseline, Week 52|Full analysis population of participants >= 8 years old. Due to the age restriction and small study population, the number of participants analyzed is too small for results to be meaningful.||||||
2805632|NCT00483379|Secondary|Change From Baseline in Ventilator Use at Last Assessment (Approximately Week 52)|The change from baseline in ventilator use at the last assessment is summarized as improved (less use of ventilator support), no change, worsened (increased use of ventilator support), and did not use ventilator support.|Baseline, approximately Week 52|Full analysis population. The participant in the worsened category died after week 52.|||participants|||Number
2805633|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass Index (LVMI) at Week 52|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline and after 12 months of treatment (Week 52). Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Baseline, Week 52|Full analysis population of participants with LVMI data at both timepoints|||g/m^2||Full Range|Median
2805634|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass Index (LVMI)|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline. Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Day 0|Full analysis population of participants with LVMI data|||g/m^2||Full Range|Median
2805635|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass (LVM) Z-Score at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children's Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Baseline, Week 52|Full analysis population of participants with LVM data at both timepoints|||Z-score||Full Range|Median
2805636|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass (LVM) Z-Scores|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. Negative values indicate a smaller than mean LVM and values higher than 0 indicate a larger LVM than the mean. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children's Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Day 0|Full analysis population of participants with LVM data|||Z-score||Full Range|Median
2805637|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Respiratory Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; respiratory decline as measured by change in ventilator use is summarized in this outcome. Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in respiratory function while on standard treatment.|||participants|||Number
2805638|NCT00483327|Secondary|Number of Women Who Became Pregnant||up to 3 years after the treatment for each patient|Only 7 participants in the trial pursued pregnancy.|||participants|||Number
2805639|NCT00483327|Secondary|Duration of Response|For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.|up to 4 years|The original PI for this study is no longer at our institution. Additionally, co-investigator has stated that this data was not collected and therefore not analyzed. This information is not available for reporting as it does not exist.||||||
2805641|NCT00483327|Primary|Best Pathologic Responses|Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate.|up to 24 months|Patient who were able to complete at least one full course (12 weeks) of treatment|||participants|||Number
2805642|NCT00483262|Secondary|Progression-Free Survival|Median time to progression or death|10 months||||month||95% Confidence Interval|Median
2805643|NCT00483262|Primary|Best Response to Combination Treatment|Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma|10 months|All patients included in analysis|||percentage of patients||90% Confidence Interval|Number
2805644|NCT00483262|Primary|Toxicity. Number of Patients With Specific Toxicities Are Reported.|Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.|10 months|Any patient who was treated was included in the analysis.|||percentage of patients||95% Confidence Interval|Number
2805645|NCT00483223|Secondary|Progression Free Survival and Overall Survival|Median progression free survival and overall survival (progression determined using RECIST) during a median follow-up time of 50 months.|5 years||||Months||Full Range|Median
2805646|NCT00483223|Secondary|Objective Response Rate Categorized by Subgroup|The number of participants achieving an objective response (as determined by RECIST) categorized by treatment cohort and whether the treatment was first or second line treatment. First line treatment means that the drug used was the first drug used for the treatment of the primary cancer. Second line treatment means that a first line treatment failed to produce the desired response, so a new drug was used for treatment.|3 years|Response rate is divide by drug cohort and categorized by first or second-line treatment|||Participants|||Count of Participants
2805647|NCT00483223|Primary|Response Rate Categorized by p63/p73 Ratio|Response rate categorized by pre-specified ΔNp63/TAp73 expression ratio cutoff in the primary tumors from this patient cohort as a bio-marker to predict response to cisplatin or carboplatin. Response is defined as partial or completed response as determined by RECIST. Expression ratio was measured using quantitative RT-PCR (Reverse transcription polymerase chain reaction).|3 years|Patients from either cohort with a tumor sample available to evaluate for expression ratio.|||Participants|||Count of Participants
2805648|NCT00483223|Primary|Objective Response Rate|"Objective response rate (ORR) (complete response [CR]+ partial response [PR]) by RECIST (Response Evaluation Criteria In Solid Tumors).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions, taking as reference the baseline sum LD~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|3 years||||Participants|||Count of Participants
2805649|NCT00483184|Secondary|Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety||12 weeks|||||||
2805650|NCT00483184|Primary|Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.|"A patient with a 75% or greater decrease in total OU for three visits was considered a sustained responder."|(0-12 weeks)||||patients with sustained response|||Number
2805651|NCT00483119|Secondary|Ability to be Weaned Off Steroids||Measured 6 and 10 weeks after initiation of IVIg treatment|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
2805652|NCT00483119|Secondary|Toxicity of Treatment: Measured in Renal Toxicity, Myelosuppression or Hepatic Toxicity||Throughout course of study|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
2805653|NCT00483119|Primary|Serum Levels of Pemphigus Antibodies||6-10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
2805654|NCT00483119|Primary|Clinical Outcome: Extent and Severity of Disease||6 - 10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.||||||
2805655|NCT00483041|Secondary|Volume at Distribution (Vz)|Vz of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Milliliter||Geometric Coefficient of Variation|Geometric Mean
2805656|NCT00483041|Secondary|Volume at Steady State (Vss)|Vss of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Milliliter||Geometric Coefficient of Variation|Geometric Mean
2805657|NCT00483041|Secondary|Terminal Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Day||Geometric Coefficient of Variation|Geometric Mean
2805658|NCT00483041|Secondary|Clearance (CL)|CL of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Milliliters per day||Geometric Coefficient of Variation|Geometric Mean
2805659|NCT00483041|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Percentage of Total Area||Geometric Coefficient of Variation|Geometric Mean
2805661|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2805662|NCT00483041|Secondary|Peak Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2805663|NCT00483041|Secondary|Time to Peak Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)|||Day||Geometric Coefficient of Variation|Geometric Mean
2805664|NCT00483041|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, and 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). One subject in the 9 mg/kg group had no sample collected on Day 126.|||Participants|||Number
2805665|NCT00483041|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).|||Participants|||Number
2805666|NCT00483041|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).|||Participants|||Number
2805667|NCT00483041|Primary|Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL)|The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.|Baseline (2 to 4 weeks prior to Day 0) and Day 15|All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group).|||Picograms per milliliter|||Number
2805668|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence for at Least Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|At least Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2805669|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 7 through Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2805670|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 3 through Week 7|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2805671|NCT00482911|Secondary|Changes in Gene Expression, Methylation and Protein Modification|Ribonucleic acid (RNA), deoxyribonucleic acid (DNA) and protein obtained from blood, urine and/or tissue was to be evaluated for changes in gene expression, methylation and/or protein modification.|Baseline and end of treatment course 1 and 2, approximately 42 days|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished||||||
2805672|NCT00482911|Secondary|Progression Free Survival|Proportion of patients who progress or die after the start of treatment|up to 16 months|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished||||||
2805673|NCT00482911|Primary|Overall Survival|Time from date of on study to the date of death from any cause or last follow up|up to 16 months|Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished.||||||
2805674|NCT00482911|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16 months|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.|||Participants|||Number
2805675|NCT00482911|Primary|Response Rate (Complete and Partial Response)|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.|||Participants|||Number
2805676|NCT00482729|Other Pre-specified|Number of Patients With A1C < 7.0% at Week 44||Week 44|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.|||Participants|||Number
2805677|NCT00482729|Other Pre-specified|Change From Baseline in A1C at Week 44|A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.|Baseline and Week 44|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.|||Percent||95% Confidence Interval|Least Squares Mean
2805678|NCT00482729|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.|||mg/dL||95% Confidence Interval|Least Squares Mean
2805679|NCT00482729|Secondary|Number of Patients With A1C < 7.0% at Week 18||Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.|||Participants|||Number
2805680|NCT00482729|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 18|A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.|||Percent||95% Confidence Interval|Least Squares Mean
2805681|NCT00482703|Other Pre-specified|Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)|Progressed disease=achieving a CHR and subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose and an increase in white blood cell count (doubling of the count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done at least 2 weeks apart); meeting the criteria of accelerated or blastic phase CML at any time; having an MCyR and subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)|||participants|||Number
2805682|NCT00482703|Other Pre-specified|Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)|||participants|||Number
2805683|NCT00482703|Other Pre-specified|Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)|MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in BM: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 6)|||participants|||Number
2805684|NCT00482703|Secondary|Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants|||percentage of participants||95% Confidence Interval|Number
2805685|NCT00482703|Secondary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants|||percentage of participants||95% Confidence Interval|Number
2805686|NCT00482703|Secondary|Mutational Spectrum of BCR-ABL|Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants|||participants|||Number
2805687|NCT00482703|Secondary|Expression of BCR-ABL Gene Mutations of RNA (mRNA)|Number of participants with positive (>= 2.0 log copies/mg) and negative (<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants|||participants|||Number
2805688|NCT00482703|Secondary|Progression-Free Survival (PFS)|Progressed disease=achieving a CHR & subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose & increase in white blood cell count (doubling of count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR & subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16.|||months||95% Confidence Interval|Median
2805689|NCT00482703|Secondary|Duration of CHR|The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.|measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death|Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15.|||months||95% Confidence Interval|Median
2805690|NCT00482703|Secondary|Time to CHR|Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met|Treated participants - responders|||months||95% Confidence Interval|Median
2805691|NCT00482703|Secondary|Duration of MCyR|The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death|Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table.|||months||95% Confidence Interval|Median
2805692|NCT00482703|Secondary|Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics|Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.|Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.|Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report.|||participants|||Number
2805693|NCT00482703|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Treated participants - responders|||months||95% Confidence Interval|Median
2805694|NCT00482703|Secondary|Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Week 24|All treated participants|||percentage of participants||95% Confidence Interval|Number
2805695|NCT00482703|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.|All treated participants|||participants|||Number
2805696|NCT00482703|Primary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Week 24|All treated participants|||percentage of participants||95% Confidence Interval|Number
2805697|NCT00482677|Secondary|Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter|Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter|7 years|Patients with MGMT promoter methylated.|||Months||95% Confidence Interval|Median
2805698|NCT00482677|Secondary|Adverse Events|Evaluated according to CTCAE V3.0|7 years|||||||
2805699|NCT00482677|Secondary|Progression-free Survival|Time from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date.|7 years||||Months||95% Confidence Interval|Median
2805701|NCT00482625|Secondary|Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above|The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.|Up to 20 weeks||||participants|||Number
2805702|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-420 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-420)|20 weeks||||ng/g||Standard Deviation|Mean
2805703|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-420 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-420)|20 weeks||||ng/mL||Standard Deviation|Mean
2805704|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-774 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-774)|20 weeks||||ng/g||Standard Deviation|Mean
2805705|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-774 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-774)|20 weeks||||ng/mL||Standard Deviation|Mean
2805706|NCT00482625|Primary|Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment|Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment|Pre-treatment and post-treatment||||participants|||Number
2805707|NCT00482612|Secondary|Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period|The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.|||Number of participants|||Number
2805708|NCT00482612|Secondary|Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period|The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.|||Number of participants|||Number
2805709|NCT00482612|Secondary|Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication and had baseline and at least one post-baseline measurement for at least one efficacy assessment.|||Minutes||Standard Deviation|Mean
2805710|NCT00482612|Primary|Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication, and had baseline and at least one post-baseline measurement for at least one efficacy assessment.|||Minutes||Standard Deviation|Mean
2805711|NCT00482547|Other Pre-specified|Number of Subjects With a sUTI Catheterized for >=48 Hours.|sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days or 48 hours after catheter was removed|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.|||Participants|||Number
2805712|NCT00482547|Other Pre-specified|Number of Subjects With a bUTI Catheterized for >=48 Hours.|bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.|||Participants|||Number
2805713|NCT00482547|Secondary|Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL|The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI|10 days|Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.|||Participants|||Number
2805714|NCT00482547|Secondary|Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.|||Days||Standard Deviation|Median
2808362|NCT00462722|Secondary|Change in Thigh Cross-sectional Muscle Area||Baseline and after 9 months of training|Because of the costs associated with data analysis for this secondary outcome, we did not pursue the analysis after learning the results of the primary outcome (fat-free mass).||||||
2805715|NCT00482547|Secondary|Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.|||Days||Standard Deviation|Median
2805716|NCT00482547|Secondary|Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.|||Days||Standard Deviation|Median
2805717|NCT00482547|Primary|Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>=48 hours to 10 days|Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion.|||Days||Standard Deviation|Median
2805718|NCT00482547|Secondary|Percentage of Participants With a bUTI After Catheterization for >= 48 Hours|The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|>=48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.|||Percentage of Participants with a bUTI|||Number
2805719|NCT00482391|Secondary|Number of Patients Who Were Evaluated for Toxicity|Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.|2 years||||Participants|||Count of Participants
2805720|NCT00482391|Primary|Number of Patients Who Completed All Planned Therapy|The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.|2 years||||participants|||Number
2805721|NCT00482274|Secondary|Time to Death From Any Cause|Due to the limited enrollment, this analysis was not completed.|measured at date of death (no estimate available)|Due to the limited enrollment, this analysis was not completed.||||||
2805722|NCT00482274|Secondary|Time to Androgen Independent State|Due to the limited enrollment, this analysis was not completed.|Measured at date of documented androgen independence (no estimate available)|Due to the limited enrollment, this analysis was not completed.||||||
2805723|NCT00482274|Secondary|Time to Metastatic Disease|Due to the limited enrollment, this analysis was not completed.|Measured at Time of documented metastases (no historical estimate is available)|Due to limited enrollment, this analysis was not completed||||||
2805724|NCT00482274|Secondary|Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)|Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.|Average days to develop recurrence from treatment start date amount applicable participants|Due to the limited enrollment, this analysis was not completed.||||||
2805725|NCT00482274|Primary|Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml|Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.|While receiving study treatment (approximately 6 months)|Analysis includes all subjects who completed study regimen of 6 cycles.|||participants|||Number
2805726|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
2805727|NCT00482170|Secondary|Influence of Co-morbidities on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
2805746|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection|"Fear of Device was assessed by participant's response to question, Are you emotionally distressed or anxious about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2808828|NCT00460265|Secondary|Time to Progression|Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)|Every 6 weeks until disease progression, up to 56 months|ITT|||months||95% Confidence Interval|Median
2805728|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Standard Deviation|Mean
2805729|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||mm||Standard Deviation|Mean
2805730|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||mm||Standard Deviation|Mean
2805731|NCT00482170|Secondary|Influence of Psoriasis Area Severity Index (PASI) on Participant Perception|Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Standard Deviation|Mean
2805732|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Full Range|Median
2805733|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||years||Standard Deviation|Mean
2805734|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
2805735|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
2805736|NCT00482170|Secondary|Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Standard Deviation|Mean
2805737|NCT00482170|Secondary|Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception|Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||units on a scale||Full Range|Median
2805738|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
2805739|NCT00482170|Secondary|Influence of Gender on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||participants|||Number
2805740|NCT00482170|Secondary|Influence of Age on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||years||Standard Deviation|Mean
2805741|NCT00482170|Secondary|Short Form State-Trait Anxiety Inventory (SF STAI) Global Score|SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||units on a scale||Standard Deviation|Mean
2805742|NCT00482170|Secondary|Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection|"Side effects related to administration were assessed by participant's response to question, Do you experience pain during or immediately after the injection? scored on a 5-point Likert scale (0= none to 4= severe)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805743|NCT00482170|Secondary|Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks|"Device characteristics were assessed by participant's response to question, How much does the device look like something you would feel comfortable to use? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805744|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Feel of Device|"Device characteristics were assessed by participant's response to question, How much do you like the feel of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805745|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Look of Device|"Device characteristics were assessed by participant's response to question, How much do you like the look of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805747|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device|"Fear of Device was assessed by participant's response to question, Do you dislike injecting yourself with this device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805748|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin|"Fear of Device was assessed by participant's response to question, How nervous do you feel about inserting the needle into your skin? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805749|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections|"Fear of Device was assessed by participant's response to question, How nervous do you feel about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805750|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection|"Confidence in injection device was assessed by participant's response to question, How confident are you that you injected yourself successfully? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805751|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process|"Confidence in injection device was assessed by participant's response to question, Are you confident that you have good control over the injection process? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805752|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device|"Confidence in injection device was assessed by participant's response to question, How confident are you that you can inject yourself properly with the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805753|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time|"Confidence in injection device was assessed by participant's response to question, How confident are you that you inject the right amount of medicine every time? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805754|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections|"Confidence in injection device was assessed by participant's response to question, How confident are you in your management of your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805755|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805756|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity|"Convenience of injection device was assessed by participant's response to question, Do you think injecting etanercept will interfere with your usual daily activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805757|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.|||participants|||Number
2805758|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)|"Ease of Use of Injection Device was assessed by participant's response to question, How long does it take to perform the injection, including any preparation and disposal? where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2809038|NCT00458393|Secondary|Diagnosis of Gonorrhea During the Follow-up Period|Diagnosis of gonorrhea during the follow-up period by PCR|All of follow-up period, median of 1.2 years|All participants with at least one follow-up test for gonorrhea|||Participants|||Count of Participants
2805759|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting|"Ease of use of injection device was assessed by participant's response to question, Did you feel any hand discomfort whilst using the device? scored on a 5-point Likert scale (0= none to 4= extreme)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2805760|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting|"Ease of use of injection device was assessed by participant's response to question, How easy is it to hold the device whilst injecting? scored on a 5-point Likert scale (0= very easy to 4= very difficult)"|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2805761|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete|"Ease of use of injection device was assessed by participant's response to question, How easy is it to know when the injection is completed? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2805762|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to dispose of the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2805763|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to use the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2805764|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to perform an injection with this device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
2805765|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805766|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805767|NCT00482170|Secondary|Influence of Co-morbidities on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805768|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805778|NCT00482170|Secondary|Influence of Gender on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805769|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805770|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805771|NCT00482170|Secondary|Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805772|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805773|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805774|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805775|NCT00482170|Secondary|Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805776|NCT00482170|Secondary|Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805777|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2805779|NCT00482170|Secondary|Influence of Age on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2805780|NCT00482170|Secondary|Percentage of Participants Satisfied With Injection Device|"Participant satisfaction was assessed by asking the question Are you satisfied with your injection device? and using a dichotomous response: Yes or No."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||percentage of participants|||Number
2805781|NCT00482170|Primary|Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2805782|NCT00482170|Primary|Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2805783|NCT00482053|Secondary|Overall Survival (OS)|To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant.|3 years||||Participants|||Count of Participants
2805784|NCT00482053|Secondary|Incidence of Chronic Graft vs Host Disease (GvHD)|The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD.|3 years||||Participants|||Count of Participants
2805785|NCT00482053|Secondary|Median Time to Platelet Engraftment After Allogeneic Transplant|Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.|within 1 month|Note: all participants engrafted platelets on the same day (see below for data values).|||Days||Full Range|Median
2805786|NCT00482053|Secondary|Median Time to Neutrophil Engraftment After Allogeneic Transplant|Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.|within 1 month||||Days||Full Range|Median
2805787|NCT00482053|Secondary|Median Time to Platelet Engraftment After Autologous Transplant|Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.|within 1 month||||Days||95% Confidence Interval|Median
2805788|NCT00482053|Secondary|Median Time to Neutrophil Engraftment After Autologous Transplant|Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.|within 1 month||||Days||Full Range|Median
2805789|NCT00482053|Primary|Event-free Survival (EFS) Per Protocol|Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death.|48 months|Reported data values are limited by protocol-specified upper boundary for the timeframe of this assessment.|||months||95% Confidence Interval|Median
2805790|NCT00482014|Primary|Phase 2 - Survival Probability at 2 Years||Phase 2 randomization up to 2 years|All randomized participants in Study Phase 2.|||percentage survival||95% Confidence Interval|Mean
2805791|NCT00482014|Secondary|Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 2 randomization to the end of the treatment up to 30.0 months|All randomization participants in Study Phase 2.|||percentage of participants||95% Confidence Interval|Number
2805792|NCT00482014|Secondary|Phase 2 - Median Survival||Phase 2 randomization to death as the result of any cause up to 30.0 month|All randomized participants in Study Phase 2.|||months||95% Confidence Interval|Median
2805793|NCT00482014|Secondary|Phase 2 - Time to Progression|Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Phase 2 randomization to measured disease progression up to 24 months|All randomized participants in Study Phase 2.|||months||95% Confidence Interval|Median
2805794|NCT00482014|Secondary|Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events|Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.|Phase 2 randomization to the end of the study treatment up to 30.0 months|All randomized participants who received at least 1 dose of study drug or 1 dose of radiation therapy (RT) during Study Phase 2.|||participants|||Number
2805795|NCT00482014|Secondary|Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 1 enrollment to the end of the study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.|||percentage of participants||95% Confidence Interval|Number
2805796|NCT00482014|Secondary|Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)|Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.|Phase 1 enrollment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.|||participants|||Number
2805797|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + cisplatin treatment.|||milligrams/meter squared (mg/m²)|||Number
2805798|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + carboplatin treatment.|||milligram/milliliter*minute (mg/mL*min)|||Number
2805799|NCT00482001|Primary|Collisions|Number of collisions (on driving simulator)|Day 15||||collisions||Standard Deviation|Mean
2805800|NCT00482001|Primary|Percentage of Time in Safe Zone|Time spent in safe zone (within 10km/h of speed limit and within 0.838m of centre of driving lane), measured as %|Day 15||||percentage of time||Standard Deviation|Mean
2805801|NCT00482001|Primary|Reaction Time to Wind Gusts|Reaction time to wind gusts, measured in seconds|Day 15||||seconds||Standard Deviation|Mean
2805802|NCT00482001|Primary|Deviation From Road Position|A measure of deviation from central road position, measured in cm|Day 15||||centimeters||Standard Deviation|Mean
2805803|NCT00482001|Primary|Speed Deviation|A measure of deviation from posted speed limit, measured in km/h|Day 15||||kilometers / hour||Standard Deviation|Mean
2805804|NCT00482001|Primary|Attention Network Test (ANT)|A measure of reaction time in milliseconds, based on the speed with which participants press a key in response to a visual stimulus|Day 15||||milliseconds||Standard Deviation|Mean
2805805|NCT00482001|Primary|Psychomotor Vigilance Test (PVT)|A measure of reaction time in milliseconds, using a handheld unit, in which participants respond to a visual simulus|Day 15||||milliseconds||Standard Deviation|Mean
2805806|NCT00481988|Secondary|Beck Depression Inventory II|patient self report of depressive symptoms|Two weeks|Data for the secondary outcome measure was incompletely collected and not analyzed.||||||
2805807|NCT00481988|Primary|Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).|The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks.|Two weeks|20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.|||participants|||Number
2805808|NCT00481871|Secondary|Progression-free Survival (PFS) Time|PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1).|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study||||days||95% Confidence Interval|Median
2805809|NCT00481871|Secondary|Duration of Response|Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study||||days||Full Range|Median
2806344|NCT00476645|Primary|PSA Reduction ≥ 50%|Number of subjects with serum PSA reduction ≥ 50% at 3 months|3 months|All subjects (10 males) had castration-resistant prostate cancer. 6 had recieved prior radical prostatectomy as primary therapy. 4 had received prior chemotherapy. The majority had previously received 2 hormonal therapies. 2 had recieved radiation therapy, and 2 had recieved hormonal monotherapy.|||participants|||Number
2805810|NCT00481871|Primary|Objective Responses Assessed by International Workshop Criteria (IWC)|Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.|Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I|All patients who completed at least 1 cycle of treatment were included in the efficacy analysis|||participants|||Number
2805811|NCT00481845|Secondary|Pathologic Complete Response||1 year|CR+PR|||Participants|||Count of Participants
2805812|NCT00481845|Primary|Tumor Objective Response by MRI|Determine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD.|1 year||||Participants|||Count of Participants
2805813|NCT00481832|Secondary|Median Time to Platelet Engraftment|Complete blood counts were measured daily after allogeneic transplant. Time to platelet engraftment is defined as the number of days it takes to reach platelet count >20,000, counting from the day of transplant.|Up to 45 days||||Days||Full Range|Median
2805814|NCT00481832|Secondary|Achieving Full Donor Chimerism|Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%.|Up to 1 year||||Participants|||Count of Participants
2805815|NCT00481832|Secondary|Median Time to Neutrophile Engraftment|Complete blood counts were measured daily after allogeneic transplant. Time to neutrophil engraftment is defined as the number of days it takes to reach an absolute neutrophils count (ANC) >500, counting from the day of transplant.|up to 45 days||||Days||Full Range|Median
2805816|NCT00481832|Secondary|Overall Mortality Rate|Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death.|3 years||||percentage of participants||95% Confidence Interval|Number
2805817|NCT00481832|Secondary|Incidence of Chronic Graft Versus Host Disease (GvHD)|The development of GvHD in vaccinated patients of any grade at 6 months.|3 years||||Participants|||Count of Participants
2805818|NCT00481832|Secondary|Incidence of Acute Graft Versus Host Disease (GvHD)|The development of GvHD in vaccinated patients of any grade and at 6 months.|6 Months|Only 13 participants received both therapies and were evaluated for GVHD|||Participants|||Count of Participants
2805819|NCT00481832|Secondary|Overall Survival (OS)|Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation.|3 years||||percentage of participants||95% Confidence Interval|Number
2805820|NCT00481832|Secondary|Relapse Rate|Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation.|3 years||||percentage of participants||95% Confidence Interval|Number
2805821|NCT00481832|Secondary|Incidence of Chemotherapy-associated Pneumonitis|Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion.|3 years||||Participants|||Count of Participants
2805822|NCT00481832|Primary|Event-free Survival (EFS)|"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as disease progression/relapse and death of all causes."|3 years||||percentage of participants||95% Confidence Interval|Number
2805823|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 12|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.|||Participants|||Count of Participants
2805824|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 12|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.|||Participants|||Count of Participants
2805825|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 7|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.|||Participants|||Count of Participants
2809599|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
2805826|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed|"Biochemical and haematological parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.~N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 7|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.|||Participants|||Count of Participants
2805827|NCT00481767|Secondary|Number of Subjects With Pregnancies and Their Outcomes|Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.|From Day 0 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented and who reported pregnancies (and their outcomes).|||Participants|||Count of Participants
2805828|NCT00481767|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7 and from Month 7 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2805829|NCT00481767|Secondary|Number of Subjects With NOCDs and Other MSCs|New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 7 and from Month 7 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2805830|NCT00481767|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|Within 30 days (Day 0-29) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2805831|NCT00481767|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|Within 7 days (Day 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2805832|NCT00481767|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.|Within 7 days (Day 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2805833|NCT00481767|Secondary|GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2805834|NCT00481767|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2805835|NCT00481767|Primary|Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2810051|NCT00450983|Secondary|Genotype and Phenotype of Donor Killer Cell Immunoglobulin-like Receptor Expression According to Time After Hematopoietic Stem Cell Transplantation (HSCT)||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
2805836|NCT00481767|Primary|Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2805837|NCT00481676|Secondary|Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms|The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Participants|||Number
2805838|NCT00481676|Secondary|Patient's Global Assessment of Their Chronic Urticaria Symptoms|Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Participants|||Number
2805839|NCT00481676|Secondary|Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)|The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2805840|NCT00481676|Secondary|Change in the Skindex Score From Baseline to the End of the Study (Week 24)|Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2805841|NCT00481676|Secondary|Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)|The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2805842|NCT00481676|Secondary|Use of Concomitant and Rescue Medications|Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.|At Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Pills||Standard Deviation|Mean
2805843|NCT00481676|Secondary|Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2805844|NCT00481676|Secondary|Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study|Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.|At the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Participants|||Number
2805845|NCT00481676|Primary|Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2805846|NCT00481507|Secondary|Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools|Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools. Outcomes assessed by parental report via daily diary and phone follow-ups with study research assistants on days 0, 5, 10, and 15.|14 days||||Percentage of participants||95% Confidence Interval|Number
2805847|NCT00481507|Primary|Incidence of Participants With Diarrhea by Parental Report|The primary outcome was the incidence of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.|14 days|Prior estimates of the sample size showed that 62 per group would have 80% power for detecting a difference of 20% in the rates of diarrhea. This was based on the placebo group having a 10% (which is consistent with published literature) rate of diarrhea. Analysis performed used the intention to treat and no imputation was required.|||Percentage of participants||95% Confidence Interval|Number
2805848|NCT00481351|Secondary|High Density Lipoprotein||12 week||||mg/dl||Standard Deviation|Mean
2805849|NCT00481351|Secondary|Total Cholesterol||12 week||||mg/dl||Standard Deviation|Mean
2805850|NCT00481351|Secondary|CPK||12 week||||mg/dl||Standard Deviation|Mean
2805851|NCT00481351|Secondary|Alanine Aminotransferase||12 weeks||||mg/dl||Standard Deviation|Mean
2805852|NCT00481351|Primary|Low Density Lipoprotein||12week||||mg/dl||Standard Deviation|Mean
2805853|NCT00481351|Secondary|Triglyceride Fractional Clearance Rate||6week||2010-11-30|11/2010||||
2805854|NCT00481351|Primary|Cholesteryl Ester Fractional Clearance Rate||6 weeks||2011-07-31|07/2011||||
2805855|NCT00481247|Other Pre-specified|Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results|ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 <1000-500/mm^3; Grade 4 <500/mm^3. Hemoglobin: Grade 3 <8.0-6.5 g/dL; Grade 4 <6.5 g/dL. Platelets: Grade 3 <50,000-25,000/mm^3; Grade 4 <25,000/mm^3. ALT/AST: Grade 3 >5.0-20*ULN; Grade 4 >20*ULN. Total bilirubin: Grade 3 >3-10*ULN; Grade 4 >10*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 >3.0-6.0*ULN; Grade 4 >6.0*ULN. Phosphate: Grade 3 <2.0-1.0 mg/dL; Grade 4 <1.0 mg/dL. Calcium: Grade 3 <7.0-6.0 mg/dL; Grade 4 <6.0 mg/dL. Potassium: Grade 3 <3.0-2.5 mmol/L; Grade 4 <2.5 mmol/L.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|Participants with laboratory assessments|||Participants|||Number
2805856|NCT00481247|Other Pre-specified|Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|All treated participants|||Participants|||Number
2805857|NCT00481247|Secondary|Percentage of Participants With Overall Survival (OS)|OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.|Participants were followed-up for at least 5 years|All randomized participants|||Percentage of participants|||Number
2805858|NCT00481247|Secondary|Percentage of Participants With Progression-free Survival (PFS)|PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.|Participants were followed-up for at least 5 years|All randomized participants|||Percentage of participants|||Number
2805859|NCT00481247|Secondary|Time to Major Molecular Response (MMR) Overall|The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All participants who received treatment and achieved MMR|||Months||95% Confidence Interval|Median
2805860|NCT00481247|Secondary|Time to Confirmed Complete Cytogenic Response (cCCyR) Overall|"The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.~."|Day 1 to 5 years|All randomized participants who achieved cCCyR|||Months||95% Confidence Interval|Median
2805861|NCT00481247|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Any Time|Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).|Planned total follow-up duration of 5 years|All randomized participants|||Percentage of participants|||Number
2805870|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Endpoint are presented."|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed by CGI-BP at Baseline and at least one observation after Baseline.|||Participants|||Number
2805862|NCT00481247|Secondary|Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.~Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1."|Years 2, 3, 4 and 5|All randomized participants who achieved cCCyR|||percentage of participants||95% Confidence Interval|Number
2805863|NCT00481247|Primary|Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.|Pretreatment, every 3 months up to 12 months|All randomized participants|||Participants|||Number
2805864|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 8 are presented."|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at week 8|||Participants|||Number
2805865|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 6 are presented."|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at Week 6|||Participants|||Number
2805866|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 4 are presented."|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at 4 weeks|||Participants|||Number
2805867|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 3 are presented."|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at 3 weeks|||Participants|||Number
2805868|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 2 are presented."|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and week 2|||Participants|||Number
2805869|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 1 are presented."|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at Baseline and Week 1|||Participants|||Number
2806810|NCT00473746|Secondary|Phase 2: Overall Survival|Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause.|Up to Month 60|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2805871|NCT00481195|Secondary|Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805872|NCT00481195|Secondary|Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805873|NCT00481195|Secondary|Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline).|baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the HAM-A at baseline and at least once after baseline|||Units on a scale||Standard Error|Least Squares Mean
2805874|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed questionnaire at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805875|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the questionnaire at baseline and at 4 weeks.|||Units on a scale||Standard Error|Least Squares Mean
2805876|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the questionnaire at baseline and at any appropriate time point after baseline|||Units on a scale||Standard Error|Least Squares Mean
2805877|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 8 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805878|NCT00481195|Secondary|Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 6 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805937|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|Safety analysis set.|||Participants|||Number
2805879|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805880|NCT00481195|Secondary|Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at week 3|||Units on a scale||Standard Error|Least Squares Mean
2805881|NCT00481195|Secondary|Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805882|NCT00481195|Secondary|Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 1 week|||Units on a scale||Standard Error|Least Squares Mean
2805883|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at least one observation after baseline.|||Units on a scale||Standard Error|Least Squares Mean
2805884|NCT00481195|Secondary|Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 8|||Units on a scale||Standard Error|Least Squares Mean
2805885|NCT00481195|Secondary|Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 4|||Units on a scale||Standard Error|Least Squares Mean
2805886|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint.|Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)|Full analysis set defined as subjects who had both a baseline observation and at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2805938|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|The safety analysis set was defined as all participants who received at least 1 dose of study treatment.|||Participants|||Number
2805887|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
2805888|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at week 4|||Units on a scale||Standard Error|Least Squares Mean
2805889|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2805890|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8|||Units on a scale||Standard Error|Least Squares Mean
2805891|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by IDS C30 at baseline and Week 4|||Units on a scale||Standard Error|Least Squares Mean
2805892|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline and at least one observation after baseline|||Units on a scale||Standard Error|Least Squares Mean
2805893|NCT00481195|Secondary|"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline|||Participants|||Number
2805917|NCT00481065|Primary|Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine|"Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH).~Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
2805894|NCT00481195|Secondary|"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline|||Participants|||Number
2805895|NCT00481195|Secondary|"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a response (> 50% decrease from baseline in total score)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline|||Participants|||Number
2805896|NCT00481195|Secondary|Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11).|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had completed IDS-C30 at baseline and at least one observation after baseline|||Participants|||Number
2805897|NCT00481195|Secondary|The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed at baseline and at 8 weeks with the IDS-C30.|||Units on a scale||Standard Error|Least Squares Mean
2805898|NCT00481195|Secondary|The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 6 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805899|NCT00481195|Secondary|The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 4 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805900|NCT00481195|Secondary|The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 3 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805901|NCT00481195|Secondary|The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 2 weeks|||Units on a scale||Standard Error|Least Squares Mean
2805902|NCT00481195|Secondary|The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at week 1 after start of study drug administration|||Units on a scale||Standard Error|Least Squares Mean
2805903|NCT00481195|Primary|The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.|Baseline and 8 weeks from start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at least one time point after baseline|||Units on a scale||Standard Error|Least Squares Mean
2805904|NCT00481078|Secondary|Overall Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year||||Months||95% Confidence Interval|Median
2805905|NCT00481078|Secondary|Progression-free Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year||||Months||95% Confidence Interval|Median
2805906|NCT00481078|Primary|Response Rate|"Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).~Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment."|Assessed every two cycles||||percentage of responding patients||95% Confidence Interval|Number
2805907|NCT00481065|Secondary|Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.|21 days after booster vaccination (day 403)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
2805908|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
2805909|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
2805910|NCT00481065|Secondary|Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|"Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.~The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382."|21 days after booster vaccination (day 403)|Full analysis set (FAS)|||Subjects|||Number
2805911|NCT00481065|Primary|Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second vaccination (day 43)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
2805912|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
2805913|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
2805914|NCT00481065|Primary|Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)|"seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second vaccination (day 43)|The analysis was done on the full analysis set (FAS).|||Subjects|||Number
2805915|NCT00481065|Secondary|Number of Subjects Reporting Local and Systemic Reactions by Vaccination|The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.|21 days after second and third vaccinations (day 43 and day 403)||||Subjects|||Number
2805916|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine|Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.|21 days after second and third vaccinations (day 22 and day 43)|Full analysis set (FAS)|||Ratio||95% Confidence Interval|Geometric Mean
2806452|NCT00475501|Primary|1 Repetition Maximum (1-RM) Strength Testing|1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.|baseline, 3 months, 6 months, 9 months, 12 months|per protocol|||kg||Standard Error|Mean
2805918|NCT00480987|Primary|Number of Participants With Objective Response|Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow.|After 2 months|Analysis was per protocol. All participants treated were analyzed.|||Participants|||Number
2805919|NCT00480857|Secondary|The Number of Patients Alive|The number of patients alive at 4 years.|4 years||||Participants|||Count of Participants
2805920|NCT00480857|Secondary|The Number of Patients That Experience Evidence of Local Recurrence|The number of patients that have local disease recurrence by imaging and clinical findings.|4 years||||Participants|||Count of Participants
2805921|NCT00480857|Secondary|The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities|"To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.~G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening"|4 years||||percentage of patients|||Number
2805922|NCT00480857|Secondary|Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less|To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.|4 years||||patients|||Number
2805923|NCT00480857|Primary|Percentage of Patients Alive Without Progression at 4 Years|The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.|4 years||||percentage of patients||95% Confidence Interval|Number
2805924|NCT00480779|Secondary|Change in Triglycerides|A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Inter-Quartile Range|Median
2805925|NCT00480779|Secondary|Change in Diastolic Blood Pressure|A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mmHg||Standard Deviation|Mean
2805926|NCT00480779|Secondary|Change in Systolic Blood Pressure|A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mmHg||Standard Deviation|Mean
2805927|NCT00480779|Secondary|Change in Hemoglobin A1C|A secondary outcome for this study will be change in HbA1c, measured pre and post intervention. The hemoglobin HbA1c test provides information regarding how well blood glucose (sugar) has been controlled for the previous 8-12 weeks..|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2805928|NCT00480779|Secondary|Change in Fasting Glucose|A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
2805929|NCT00480779|Secondary|Change in LDL Cholesterol|A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
2805930|NCT00480779|Secondary|Change in HDL Cholesterol|A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
2805931|NCT00480779|Secondary|Change in Total Cholesterol|A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.|||mg/dl||Standard Deviation|Mean
2805932|NCT00480779|Secondary|Change in Waist Circumference|A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.|Baseline and 3 months|Intent to treat|||inches||Standard Deviation|Mean
2805933|NCT00480779|Primary|Change in Weight|The primary outcome for this study will be change in weight measured pre and post intervention.|Baseline and 3 months|Intent to treat using Last Observation Carried Forward (LOCF)|||pounds||Standard Deviation|Mean
2805934|NCT00480740|Primary|Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.|"Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values.~Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia."|Up to 24 hours following cardiac catheterization||||percentage of change from baseline||95% Confidence Interval|Mean
2805935|NCT00480636|Secondary|Number of Participants With Recurrent DVT|Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits|Month 6 or EOT (up to Month 6)|FAS|||Participants|||Number
2805936|NCT00480636|Secondary|Percent of Participants With and Without Pulmonary Embolism (PE)|PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)|Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)|FAS. n = number of participants per PE status at observation.|||Percent of participants|||Number
2807264|NCT00468858|Primary|Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period|Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)|Within the 31-day (days 0-30) follow-up period after each vaccine dose||||Participants|||Count of Participants
2805939|NCT00480636|Primary|Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg|Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg|Month 6 or End of Treatment (EOT) (up to Month 6)|Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.|||Participants|||Number
2805940|NCT00480532|Secondary|Subject Compliance|measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study|Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.||||number of participants with no missed pi|||Number
2805941|NCT00480532|Secondary|Subject Satisfaction.|"measured using 100 mm visual analog scale. anchors of not at all satisfied (0mm) extremely satisfied (100mm)"|Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.||||mm||Standard Deviation|Mean
2805942|NCT00480532|Primary|Differences in Bleeding Patterns Between Study Groups.|number of days of bleeding and spotting, self reported on calendar|The outcome was also assessed for day 1 to 84|All participants analyzed in the groups to which they were randomized except for 1 subject in prevention placebo group who was erroneously enrolled although she did not meet enrollment entry criteria|||days||Standard Error|Mean
2805943|NCT00480493|Primary|Worry|Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry|12 months||||units on a scale||Standard Deviation|Mean
2805944|NCT00480493|Primary|Parent Concern|Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.|12 months||||units on a scale||Standard Deviation|Mean
2805945|NCT00480493|Primary|Maternal Confidence Scale|Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)|12 months|All participants with data were analyzed|||units on a scale||Standard Deviation|Mean
2805946|NCT00480441|Primary|Tolerability of Treatment|Reports of side effects leading to discontinuation of treatment were examined in all participants.|baseline to two years|"Non-Randomized participants were not measured because they were not included in the neuroimaging study.~The only data available (summary level) is presented. Despite all good faith efforts, no access to individual data is available."|||participants|||Number
2805947|NCT00480441|Primary|Physiological Changes in Response to Cue-induced Craving.|Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.|Baseline functional mri (fMRI), (prior to randomization)|All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.|||T value|||Number
2805948|NCT00480324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2805949|NCT00480324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2805950|NCT00480324|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.|During the 8-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2805951|NCT00480324|Secondary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.|||subjects|||Number
2805952|NCT00480324|Secondary|Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration|Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.|||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
2805953|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From Dose 1 up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
2805954|NCT00480324|Secondary|Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
2806603|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2805955|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
2805956|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
2805957|NCT00480324|Secondary|Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
2805958|NCT00480324|Primary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.|||subjects|||Number
2805959|NCT00480077|Primary|Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization|Number of participants with a combined end point of all-cause mortality or heart failure hospitalization|14.9 ± 5.4 months||||Participants|||Count of Participants
2805960|NCT00480025|Secondary|Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)|A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE.|From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 2.5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805961|NCT00480025|Secondary|Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported.|Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 2.5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805962|NCT00480025|Secondary|Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade|The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805963|NCT00480025|Secondary|Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade|The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2806018|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2805964|NCT00480025|Secondary|Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade|The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805965|NCT00480025|Secondary|Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade|The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805966|NCT00480025|Secondary|Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade|The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805967|NCT00480025|Secondary|Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade|The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805968|NCT00480025|Secondary|Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade|The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805969|NCT00480025|Secondary|Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade|The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805970|NCT00480025|Secondary|Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade|The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805971|NCT00480025|Secondary|Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade|The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.|From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as treated included patients in the treatment group as per treatment actually received.|||Participants|||Count of Participants
2805978|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population|DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2809039|NCT00458393|Secondary|Incidence of HSV-2 During the Follow-up Period|Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline|Total study follow-up, a median of 1.2 years|All HSV-2 negative participants with a follow-up HSV-2 test.|||Participants|||Count of Participants
2805972|NCT00480025|Secondary|Health-related Quality of Life (HQL) Scores|HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state).|At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120|The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.|||Scores on a scale||Standard Deviation|Mean
2805973|NCT00480025|Secondary|Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)|A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.|At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)|The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.|||Participants|||Count of Participants
2805974|NCT00480025|Secondary|Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)|A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies >= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).|Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)|The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.|||Participants|||Count of Participants
2805975|NCT00480025|Secondary|Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)|A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >=/< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration >= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration >= 2 fold the pre-treatment antibody concentration.|At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)|The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.|||Participants|||Count of Participants
2805976|NCT00480025|Secondary|Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)|A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).|Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)|The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.|||Participants|||Count of Participants
2805977|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population|DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.|Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805999|NCT00479882|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2805979|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population|DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805980|NCT00480025|Secondary|Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population|DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.|KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||percent probability||95% Confidence Interval|Median
2805981|NCT00480025|Secondary|Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population|DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.|KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||percent probability||95% Confidence Interval|Median
2805982|NCT00480025|Secondary|Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population|DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.|KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||percent probability||95% Confidence Interval|Median
2805983|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population|LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805998|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2810052|NCT00450983|Secondary|Cytomegalovirus-specific T Cells in Product and Donor Graft||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
2805984|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population|DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805985|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population|LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805986|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population|LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805987|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population|OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805988|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population|OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805989|NCT00480025|Secondary|Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population|OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805990|NCT00480025|Primary|Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population|DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2806045|NCT00479401|Secondary|Likert Scale for Pain Related to PD|Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2805991|NCT00480025|Primary|Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population|DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.|From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)|The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.|||events/person-years|||Number
2805992|NCT00479882|Secondary|Percentage Change From Baseline in HDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2805993|NCT00479882|Secondary|Percentage Change From Baseline in LDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2805994|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2805995|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2805996|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined, where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). Excludes 6 participants who had an AE that began during the placebo run-in.|||Percentage of Participants|||Number
2805997|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806000|NCT00479882|Secondary|Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline|Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806001|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806002|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806003|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806004|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806005|NCT00479882|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806006|NCT00479882|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
2806007|NCT00479882|Secondary|Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2806008|NCT00479882|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2806009|NCT00479856|Secondary|Number of Participants With the Indicated Serious Adverse Events and Adverse Events|Qualitative and quantitative toxicities associated with the combination of capecitabine, docetaxel, or nab-paclitaxel and lapatinib were measured. Data are presented as serious adverse events (SAEs) and adverse events (AEs). See the SAE/AE section of the results record for data.|Baseline through End of Treatment, or discontinuation of study therapy (approximately 95 weeks); from the first dose of lapatinib until 5 days after the last dose of lapatinib||||participants|||Number
2806010|NCT00479856|Secondary|Progression-free Survival|The time from the start of treatment until the earliest date of disease progression or death due to any cause was measured.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks); dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint of overall response rate was evaluated.|||weeks||95% Confidence Interval|Median
2806011|NCT00479856|Secondary|Time to Response (TTR)|TTR is defined as the time from the start of treatment until the first documented evidence of PR or CR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the TTR was taken to be the first time that the response was observed.|start of treatment until first documented evidence of CR or PR (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.|||weeks||95% Confidence Interval|Median
2806012|NCT00479856|Secondary|Duration of Response|For the subset of participants with a confirmed CR or PR, duration of response was measured as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|time from first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.|||weeks||95% Confidence Interval|Median
2806013|NCT00479856|Secondary|Clinical Benefit (CB)|CB is defined as the percentage of participants (par.) with either a confirmed CR or PR or stable disease (SD) for at least 24 weeks. SD is defined as small changes that do not meet criteria for CR, PR, or Progressive Disease (defined as at least a 20% increase in the sum of the longest diameter of target lesions).|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible par., the study was terminated with only 9 out of the 45 planned par. enrolled. As there were too few par. to derive statistically meaningful conclusions, only the primary endpoint was evaluated.|||percentage of participants|||Number
2806014|NCT00479856|Primary|Overall Tumor Response|Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment|||percentage of participants|||Number
2806015|NCT00479765|Primary|Occurence of Dose-limiting Toxicities (DLTs)|any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)|8 weeks||||dose limiting toxicities|||Number
2806016|NCT00479713|Other Pre-specified|Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein|Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Median
2806017|NCT00479713|Other Pre-specified|Percent Change From Baseline in Apolipoprotein B|Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2806083|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-909/-908GC>TT Genotype|The GNAQ c.-909/-908GC>TT single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806019|NCT00479713|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2806020|NCT00479713|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)|Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2806021|NCT00479713|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2806022|NCT00479713|Other Pre-specified|Percent Change From Baseline in Triglycerides.|Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Median
2806023|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2806024|NCT00479713|Secondary|The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment|"The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.~The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group."|after 6 weeks of treatment|Full Analysis Set (FAS)|||Percent of participant population|||Number
2806025|NCT00479713|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment|Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2806026|NCT00479674|Secondary|to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)||18 months|Study plan stipulated that tissue samples would not be assessed for quantitatively if no difference in SPARC expression was observed between tumor and non-tumor cells was observed qualitatively.||||||
2806027|NCT00479674|Secondary|to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy||18 months|Samples were collected, but analysis was not performed as there was inadequate funding to support the testing and analysis of samples.||||||
2806028|NCT00479674|Secondary|To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers||18 months|Analysis of samples was not performed, as there was inadequate funding to support the testing and analysis of the samples.||||||
2806029|NCT00479674|Secondary|Median Proportion Progression-free as Estimated by Kaplan-Meier Methods|PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.|5 years|One subject lost to follow up and not included in analysis.|||months||95% Confidence Interval|Median
2806030|NCT00479674|Primary|"Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III Triple Negative Metastatic Breast Cancer."|Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.|5 years|2 subjects withdrew and were not assessed for response|||percentage of participants||95% Confidence Interval|Number
2806031|NCT00479557|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|||||||
2806032|NCT00479557|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
2806084|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2291C>T Genotype|The GNAS c.2291C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806033|NCT00479557|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/mL||95% Confidence Interval|Geometric Mean
2806034|NCT00479557|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.|The safety population included all randomized participants with documented use of at least one dose of study drug.|||percentage of participants|||Number
2806035|NCT00479466|Secondary|Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2806036|NCT00479466|Secondary|Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2806037|NCT00479466|Primary|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2806038|NCT00479401|Secondary|Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events||baseline and after 33 weeks of treatment|Treated set (TS)|||participants|||Number
2806039|NCT00479401|Secondary|Possible Clinically Significant Abnormal Laboratory Parameters|The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.|baseline and after 33 weeks of treatment|Treated Set Labs (TSLabs), all patients in TS with a clinical laboratory measurements at baseline and at the last visit.|||participants|||Number
2806040|NCT00479401|Secondary|Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)|mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).|from trial start on to any time before final assessment of the patient, up to 33 weeks|Treated Set (TS), all randomized patients, who were dispensed study medication and documented to have taken at least 1 dose of study medication.|||patients|||Number
2806041|NCT00479401|Secondary|Patients Who Started to Use L-Dopa Rescue Medication|L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population|from trial start on to any time before final assessment of the patient, up to 33 weeks|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||patients|||Number
2806042|NCT00479401|Secondary|Change From Baseline in European Quality of Life Visual Analog Scale|European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2806043|NCT00479401|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include:~mobility (e.g. fear of falling when walking): 10 items~activities of daily living (e.g. difficulty cutting food): 6 items~emotional well-being (e.g. feelings of isolation): 6 items~stigma (e.g. social embarrassment): 4 items~social support: 3 items~cognition: 4 items~communication: 3 items~bodily discomfort: 3 items.~A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement."|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2806044|NCT00479401|Secondary|Parkinson's Disease Sleep Scale (PDSS)|PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2809058|NCT00458393|Primary|HIV Seroconversion|Confirmed HIV infection|Monthly follow-up through a median of 1.2 years|Excludes participants who were HIV+ at enrollment (2 TDF/FTC, 8 Placebo) and those with no follow-up HIV test (25 TDF/FTC and 22 Placebo).|||Participants|||Count of Participants
2806046|NCT00479401|Secondary|Beck's Depression Inventory Version I A|The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2806047|NCT00479401|Secondary|UPDRS Part III Total Score|UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2806048|NCT00479401|Secondary|UPDRS Part II Total Score|UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Mean
2806049|NCT00479401|Secondary|UPDRS Part I Change From Baseline|UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement|baseline and after 33 weeks treatment|Full Analysis Set with (LOCF), all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||Inter-Quartile Range|Median
2806050|NCT00479401|Secondary|UPDRS II+III Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||percentage of responders|||Number
2806051|NCT00479401|Secondary|Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale|Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score.|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008|||Percentage of Participants|||Number
2806052|NCT00479401|Secondary|Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale|Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008|||Percentage of Participants|||Number
2806053|NCT00479401|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.|baseline and after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment|||units on a scale||95% Confidence Interval|Least Squares Mean
2806054|NCT00479388|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement|||Percent||95% Confidence Interval|Median
2806055|NCT00479388|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set|||Percent||95% Confidence Interval|Least Squares Mean
2806056|NCT00479388|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set|||Percent||95% Confidence Interval|Least Squares Mean
2806057|NCT00479336|Secondary|Abdominal Circumference|Change in abdominal circumference from baseline (LOCF)|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF|||cm||Standard Deviation|Mean
2806058|NCT00479336|Primary|Body Weight (Amount of Change)|Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF|||Kg||Standard Deviation|Mean
2806059|NCT00479258|Secondary|7 Point Home Glucose||12 months|||||||
2806060|NCT00479258|Secondary|Hypoglycemic Event Rates;||12 months|||||||
2806061|NCT00479258|Secondary|Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;||12 months|||||||
2806062|NCT00479258|Secondary|Change From Baseline in Insulin Antibodies (microU/mL);||12 months|||||||
2806063|NCT00479258|Secondary|Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c||12 months|||||||
2806064|NCT00479258|Secondary|Slope for Other PFT Parameters;||12 months|||||||
2806065|NCT00479258|Secondary|Change From Baseline in FVC||12 months|||||||
2806066|NCT00479258|Secondary|Treatment Preferences.||12 months|||||||
2806067|NCT00479258|Secondary|Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;||12 months|||||||
2806068|NCT00479258|Secondary|Change From Baseline in Other PFT Parameters||12 months|||||||
2806069|NCT00479258|Primary|To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period|No subjects were dosed therefore no data collected.|12 months|No subjects were dosed therefore no participants for analysis.||||||
2806070|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with intermediate-high risk MDS or untreated AML who were treated with vorinostat and decitabine either on a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for MDS participants.|Approximately 6 months||||percentage of participants|||Number
2806071|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with refractory or relapse AML (acute myelogenous leukemia) in combination with Decitabine who were treated with vorinostat and decitabine on either a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for Myelodysplastic Syndrome (MDS) participants.|Approximately 6 months||||percentage of participants|||Number
2806072|NCT00479232|Primary|Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events|Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.|Day 1 to 28 of Cycle 1||||participants|||Number
2806073|NCT00479154|Primary|Change in Restless Legs Syndrome Rating Scale|Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40).|Week 2 and Week 4 for each intervention (vs. baseline)||||RLS Rating Score||Standard Deviation|Mean
2806074|NCT00479089|Secondary|Median Progression Free Survival From Trial Enrollment for Overall Study|Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|From trial enrollment to disease progression or death, up to five years|Analysis by intent to treat population with all participants treated included.|||Months||Full Range|Median
2806075|NCT00479089|Secondary|Median Overall Survival|Overall survival was summarized using the Kaplan-Meier estimation.|Baseline till participant death or end of follow-up period, assessed every 4 weeks, up to 5 years.|Analysis by intent to treat population with all participants treated included.|||Months||Full Range|Median
2806076|NCT00479089|Primary|Number of Participants Free From Progression 9 Months From Start of Consolidation Therapy|The proportion of participants' progression free at 9 months compared between treatments using chi-square. Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|Assessment at 9 Months of therapy|In order to test the trial hypotheses for the two cohorts progression at nine months, a sample size of 45 participants for each arm was required. Accrual was not met to assess the outcome hypotheses thus no participant analysis available.||||||
2806077|NCT00479037|Secondary|Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial|"CTX is a marker of bone resorption, which is a degradation product of bone collagen.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||percent change||Standard Deviation|Mean
2806078|NCT00479037|Primary|Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial|"BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||percent change||Standard Deviation|Mean
2806079|NCT00479037|Primary|Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial|"P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||percent change||Standard Deviation|Mean
2806080|NCT00478933|Primary|Outcome Measure Title: Number of Patients With Ventricular Arrhythmia <400 Msec. by GNB3 c.825C>T Genotype|The GNB3 c.825C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806081|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-387G>A Genotype|The GNAQ c.-387G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806082|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAQ c.-382G>A Genotype|The GNAQ c.-382G>A single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806085|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.2273C>T Genotype|The GNAS c.2273C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806086|NCT00478933|Secondary|All Cause Mortality, Cardiac Death and Atrial Fibrillation/Flutter||2 years|||||||
2806087|NCT00478933|Secondary|Hospitalization, Medical Interventions, Medication, Surgery, Additional Diagnostics||2 years|||||||
2806088|NCT00478933|Primary|Number of Patients With Ventricular Arrhythmia <400 Msec. by GNAS c.393C>T Genotype|The GNAS c.393C>T single nucleotide polymorphism (SNP) was one of seven SNP's analyzed. Patients with de novo ICD implants were genotyped and followed for up to 2 years. All episodes of arrhythmia <400 msec. detected by the device were adjudicated by an independent committee. The number of patients with true arrhythmias <400 msec were tracked by genotype.|2 years||||participants with VT < 400 msec|||Number
2806089|NCT00478881|Secondary|Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks|The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||scores on a scale||Standard Error|Least Squares Mean
2806090|NCT00478881|Secondary|Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older|Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|mITT: Participants who received at least one dose, randomized correctly according to Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. Qmax is based on men predominantly aged 50 years and older but includes a few males who had Qmax collected even if younger than 50 years.|||milliliter per second (mL/s)||Standard Error|Least Squares Mean
2806091|NCT00478881|Secondary|Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks|The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||involuntary discharges per day||Standard Error|Least Squares Mean
2806092|NCT00478881|Secondary|Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks|The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||urgencies per day||Standard Error|Least Squares Mean
2806093|NCT00478881|Secondary|Change From Baseline in Volume at First Desire to Void at 6 Weeks|Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
2806094|NCT00478881|Secondary|Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks|Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
2806095|NCT00478881|Secondary|Change From Baseline in Volume at First Detectable Leakage at 6 Weeks|First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
2806096|NCT00478881|Secondary|Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks|Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT) population: participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2806454|NCT00475423|Secondary|Cluster of Differentiation 19 (CD19) B Cell Count|Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day|Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.|||10^9 cells/L||Standard Deviation|Mean
2806097|NCT00478881|Primary|Change From Baseline in Average Number of Daily Micturitions at 6 Weeks|Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."|||micturitions per day||Standard Error|Least Squares Mean
2806098|NCT00478881|Primary|Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks|Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)|"Modified intention-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."|||mL||Standard Error|Least Squares Mean
2806099|NCT00478777|Secondary|Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria|Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.|up to 827 days|Values for the free light chain concentrations were determined to be invalid.|||Days||Standard Deviation|Mean
2806100|NCT00478777|Secondary|Participants With Treatment-emergent Adverse Experiences (TEAEs)|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 8 months|Safety population|||participants|||Number
2806101|NCT00478777|Secondary|Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria|"Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD).~CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline."|Up to 827 days|Full analysis set|||participants|||Number
2806102|NCT00478777|Primary|Kaplan Meier Estimate for Time to Disease Progression|"Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease.~Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 827 days|Full analysis dataset|||days||95% Confidence Interval|Median
2806103|NCT00478673|Primary|Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)|12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.|12 Months|ITT Analysis: All enrolled subjects who experienced a 12-mo MAE and/or completed a follow-up evaluation >=335 days post-procedure were evaluable. Subjects who experienced more than one MAE within 12 months were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 12-mo MAE.|||Participants|||Number
2806104|NCT00478673|Primary|Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)|30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.|30 Days|ITT Analysis: All enrolled subjects who experienced a 30-day MAE and/or completed a follow-up evaluation >=23 days post-procedure were evaluable. Subjects who experienced more than one MAE within 30 days were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 30-day MAE.|||Participants|||Number
2806105|NCT00478647|Primary|Participants Who Experienced at Least One Adverse Event|"Safety was assessed throughout the study by assessments including adverse events, concomitant medication use, and vital signs. Additional safety assessments, including 12-lead ECGs, physical examinations, clinical laboratory tests and determination of the presence of anti-velaglucerase alfa antibodies.~Refer to Adverse event section for further details."|Week 53|Safety population included subjects who have received at least 1 full or partial dose of study drug.|||participants|||Number
2806106|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Spleen Volume|Spleen volume has been normalized for percentage (%) of body weight. Spleen size relative to body weight= (Spleen volume [cc]/Body weight [kg])*100|Week 51|ITT population. Four splenectomized participants were excluded.|||Percent (%) change||90% Confidence Interval|Mean
2806107|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Liver Volume|Liver volume has been normalized for percentage (%) of body weight. Liver size relative to body weight= (Liver volume [cc]/Body weight [kg])*100|Week 51|ITT population.|||Percent (%) change||90% Confidence Interval|Mean
2806108|NCT00478647|Secondary|Percent Change From Baseline to Week 53 in Platelet Count||Week 53|ITT population.|||percent (%) change||90% Confidence Interval|Mean
2806109|NCT00478647|Secondary|Change From Baseline to Week 53 in Hemoglobin Concentration||Week 53|ITT population.|||g/dL||90% Confidence Interval|Mean
2806468|NCT00475423|Secondary|Percentage of Participants Who Achieved CR|CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population|||percentage of participants|||Number
2806110|NCT00478608|Secondary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|12 months after transplantation|Patients who received at least one dosing of SRL after transplantation.|||patients|||Number
2806111|NCT00478608|Secondary|Patient and Graft Survival|Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|12 months|Patients who received at least one dosing of SRL after transplantation.|||patients|||Number
2806112|NCT00478608|Secondary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Baseline, 6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values|||mg/dl||Standard Deviation|Mean
2806113|NCT00478608|Secondary|Glomerular Filtration Rate (GFR) (Nankivell Method)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.|6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values|||mL/min||Standard Deviation|Mean
2806114|NCT00478608|Primary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|6 months after transplantation|Patients who received at least one dosing of SRL after transplantation.|||patients|||Number
2806115|NCT00478569|Secondary|Treatment Compliance by Visit|"A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.~Data on compliance were obtained at each visit and relate to the period since the previous recorded visit."|From enrollment to 3, 6, 12, 18, and 24 months||||participants|||Number
2806116|NCT00478569|Secondary|Duration of Treatment|Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.|24 months|Participants for whom data were available|||months||Full Range|Mean
2806117|NCT00478569|Secondary|Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment|"A participant was defined as permanently discontinued if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as temporarily discontinued if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still ongoing during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as missing or unknown if they attended the relevant visit and there was no result or unknown was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point."|From enrollment to 3, 12, 18, and 24 months|All enrolled participants|||participants|||Number
2806118|NCT00478569|Primary|Number of Participants Who Discontinued Before 6 Months of Treatment|"A participant was defined as permanently discontinued if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards."|6 months|All enrolled participants|||participants|||Number
2806119|NCT00478556|Secondary|Bowel Opacification Score|The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.|Collected day of study|per protocol - all patients had usable data|||units on a scale||Standard Deviation|Mean
2806120|NCT00478556|Primary|Preferred Contrast Agent|The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.|1 Day|Analysis was per protocol|||participants|||Number
2806121|NCT00478426|Secondary|Time to Progression|The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body. Assessed by Kaplan and Meier method|Up to 7 years||||months||95% Confidence Interval|Median
2806122|NCT00478426|Secondary|Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0|Number of participants that experience at east 1 adverse event while on trial, according to the CTCAE.|Up to 7 years|Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment.|||Participants|||Count of Participants
2806123|NCT00478426|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|Up to 7 years|Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment.|||months||95% Confidence Interval|Median
2810053|NCT00450983|Secondary|Concentration of NK, NK-T, T-cells, and Dendritic Cell Subsets in the CD34+ NK/NK-T-enriched Graft||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
2806124|NCT00478426|Secondary|Number of Participants With Prolonged Stable Disease|Described as the best response of stable disease that is maintained for atleast 6 months|Up to 7 years|Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment.|||Participants|||Count of Participants
2806125|NCT00478426|Primary|Objective Response Rate|Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), disappearance of all target lesions.|Up to 7 years|Of the 33 participants, only 28 were considered evaluable for response.|||Participants|||Count of Participants
2806126|NCT00478335|Primary|24h Urine Volume|urine volume in mL/d|4-days||||urine volume in mL/d||Standard Deviation|Mean
2806127|NCT00478257|Primary|Fatigue|The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is −24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.|four cycles of chemotherapy|All participants that were randomized and began the protocol were included in analyses.|||units on a scale||Standard Error|Mean
2806128|NCT00478244|Primary|Number of Patients With Detectable Collagen Type VII|Number of patients with epidermolysis bullosa who had collagen type VII. Type VII collagen defects cause recessive dystrophic epidermolysis bullosa (RDEB), a blistering skin disorder often accompanied by epidermal cancers.|Day 100 Post Transplant||||participants|||Number
2806129|NCT00478244|Secondary|Number of Patients With Neutrophil Engraftment|Number of patients with an absolute neutrophil count >5 x 10^8 cells/liter for 3 consecutive days.|Day 42 Post Transplant||||participants|||Number
2806130|NCT00478244|Secondary|Number of Patients With Resistance to Blister Formation|Resistance to Blister Formation demonstrated by response to negative pressure.|Month 1 through Month 24 Inclusive|Added blister formation testing later in study; only 2 patients had pre-transplant test.|||participants|||Number
2806131|NCT00478244|Secondary|Number of Patients With Donor Derived Cells in Skin|Number of patients who had donor skin chimerism - donor cells in the patient's epidermis (a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease).|Day 90 Post Transplant||||participants|||Number
2806132|NCT00478244|Secondary|Overall Survival|Survival is defined as the number of patients that were alive post transplant.|1 year and 2 years Post Transplant||||participants|||Number
2806133|NCT00478244|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)|Number of patients with cGVHD; a severe long-term complication created by infusion of donor cells into a foreign host.|Day 365 Post Transplant||||participants|||Number
2806134|NCT00478244|Secondary|Number of Patients With Acute Graft-Versus-Host Disease (GVHD)|Number of patients with GVHD. Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100 Post Transplant||||participants|||Number
2806135|NCT00478244|Secondary|Number of Patients With Platelet Engraftment|Number of patients with a platelet count >5 x 10^10 cells/liter for 3 consecutive measurements.|Day 180 Post Transplant||||participants|||Number
2806136|NCT00478244|Secondary|Number of Patients With Transplant-Related Mortality|Number of patients who died due to complications of the transplant (includes all deaths without previous relapse or progression).|Day 180 Post Transplant||||participants|||Number
2806137|NCT00478244|Secondary|Number of Patients With >70% Donor Chimerism|Number of patients with donor chimerism - percentage of donor cells in the patient via the peripheral blood or bone marrow.|Days 21, 100, 180, 365 and 730 Post Transplant||||participants|||Number
2806138|NCT00478231|Other Pre-specified|Number of Participants With Genotype Resistance|Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).|Baseline through Week 96|FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
2806139|NCT00478231|Other Pre-specified|Time to Virologic Failure (VF)|Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.|Baseline to Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation.|||Days||95% Confidence Interval|Median
2806140|NCT00478231|Other Pre-specified|Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF.|||log 10 copies/ml||Standard Deviation|Mean
2806141|NCT00478231|Secondary|Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status|Virus tropism was done by the Monogram Biosciences Trofile assay.|Time of virologic failure (VF) and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Participants|||Number
2806142|NCT00478231|Secondary|Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percent CD8||Standard Deviation|Mean
2806143|NCT00478231|Secondary|Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percent CD4||Standard Deviation|Mean
2806144|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||cells/µL||Standard Deviation|Mean
2806145|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||cells per microliter (cells/µL)||Standard Deviation|Mean
2806146|NCT00478231|Secondary|Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification|Below limit of quantification was defined as less than 400 copies/milliliter (mL)|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percentage of participants|||Number
2806147|NCT00478231|Secondary|Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.|||Percentage of participants|||Number
2806148|NCT00478231|Secondary|Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)|The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used.|||Percentage of participants|||Number
2806149|NCT00478231|Primary|Number of Participants With Laboratory Test Abnormalities|Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
2806150|NCT00478231|Primary|Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections|Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
2806151|NCT00478231|Primary|Number of Participants With Treatment Emergent Malignancies||Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
2806152|NCT00478231|Primary|Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities|Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Participants|||Number
2806153|NCT00478231|Primary|Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or early termination (ET)|The safety analysis set composed of all participants who received at least one dose of study medication.|||Participants|||Number
2806502|NCT00475085|Primary|Home Record: Severity of Delayed Nausea|1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse|average of day 1 afternoon, evening and night, and all of days 2 and 3||||units on a scale||Standard Deviation|Mean
2806154|NCT00478218|Secondary|Duration of Response (DOR)|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Participants who achieved a partial response(PR) or better were evaluable for this analysis.|||months||95% Confidence Interval|Median
2806155|NCT00478218|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method. > Progression was defined as any one or more of the following: > An increase of 25% from lowest confirmed response in: >~Serum M-component (absolute increase >= 0.5g/dl) >~Urine M-component (absolute increase >= 200mg/24hour >~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl >~Bone marrow plasma cell percentage (absolute increase of >=10%)"|up to 5 years||||months||95% Confidence Interval|Median
2806156|NCT00478218|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years||||months||95% Confidence Interval|Median
2806157|NCT00478218|Primary|Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment|"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration of Treatment (up to 5 years)||||participants|||Number
2806158|NCT00478205|Primary|Overall Change From Baseline in Modified CIBIC+ to Week 24|The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).|Baseline and Week 24|ITT population, LOCF|||Scores on a scale||Standard Deviation|Mean
2806159|NCT00478205|Secondary|Change From Baseline to Week 24 in MMSE Total Score|The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).|Baseline and Week 24|ITT population, LOCF|||Scores on a scale||Standard Deviation|Mean
2806160|NCT00478205|Secondary|Change From Baseline to Week 24 in ADCS-ADL Total Score|The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability.|Baseline and Week 24|ITT population, LOCF|||Scores on a scale||Standard Deviation|Mean
2806161|NCT00478205|Primary|Change From Baseline to Week 24 in SIB Total Score|The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.|Baseline and Week 24|Intent-to-treat (ITT) population: All Randomized patients in Safety Population and Severe Impairment Battery (SIB) or Clinician Interview-Based Impression of Severity Plus Caregiver Input (CIBIS+) data available at Baseline and SIB or Clinician Interview-Based Impression of Change Plus caregiver Input (CIBIC+ ) data available post-Baseline; LOCF|||Scores on a scale||Standard Error|Least Squares Mean
2806162|NCT00478192|Secondary|Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment|"Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.~Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point - Baseline"|Baseline, Hour 24 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mL||Standard Deviation|Mean
2806163|NCT00478192|Secondary|Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment|"Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.~Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point - Baseline"|Baseline, Hour 12, Hour 24,Hour 36 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mL||Standard Deviation|Mean
2806164|NCT00478192|Secondary|Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours|"Each individual subject's change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.~t=48 Hours"|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Hour * mEq/L||Standard Deviation|Mean
2806165|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >6 mEq/L or two consecutive measurements >135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Patients|||Number
2806166|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Patients|||Number
2806167|NCT00478192|Secondary|Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium|"Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~The endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported."|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.|||Hours||Inter-Quartile Range|Median
2806168|NCT00478192|Secondary|Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point - Baseline"|Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mEq/L||Standard Deviation|Mean
2806169|NCT00478192|Primary|Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Hour 48 - Baseline."|Baseline and 48 hours|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."|||mEq/L||Standard Deviation|Mean
2806170|NCT00478140|Secondary|Overall Survival|Length of time from date of starting treatment that participants are still alive|Up to 3.5 years||||weeks||Full Range|Median
2806171|NCT00478140|Secondary|Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.|Up to 3 years||||participants|||Number
2806172|NCT00478140|Secondary|Disease Control Rate|Percentage of participants who have achieved complete response, partial response and stable disease|Up to 3.5 years||||percentage of participants|||Number
2806173|NCT00478140|Primary|Objective Response (Complete and Partial Response)|Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 63 days or until disease progression|Only those participants who had measurable disease present at baseline, received at least one cycle of therapy, and had disease re-evaluated considered evaluable for response; therefore one participant was inevaluable.|||participants|||Number
2806174|NCT00478062|Primary|Safety and Tolerability||After administration of last vaccine at 9 weeks|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
2806175|NCT00478062|Primary|Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses||2 years|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
2806176|NCT00478062|Primary|Durability of Immunologic Response||2 years|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
2806177|NCT00478062|Primary|Immunologic Response||9 months|The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.||||||
2806178|NCT00478036|Primary|Interocular Pressure|IOP, measured by Goldmann applanation tonometry|8 weeks|Reported for subjects for whom all IOP values were available for all of the visits.|||mmHg||Standard Deviation|Mean
2806179|NCT00478023|Secondary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline value to 48 hours after first study drug intake.|Intention to treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.|||units on scale||Standard Deviation|Mean
2806238|NCT00477464|Secondary|Trough Concentration of Capecitabine, 5-FU, and FBAL|PK samples were collected at pre-dose on Day 14 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|ITT Population. Evaluable samples were not taken from some participants.|||ng/ml||Standard Deviation|Mean
2806180|NCT00478023|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline to 24 hours after first intake of study drug|Intention to Treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.|||units on scale||Standard Deviation|Mean
2806181|NCT00477971|Post-Hoc|3-Year Progression Free Survival|"Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method.~Progression is assessed when one of the following occur:~reappearance of monoclonal protein by immunofixation,~Increase in serum monoclonal paraprotein to >25% above the lowest response level,~Increase in urine M-protein to > 25% above the lowest remission value for 24-hour excretion."|3 years||||percentage of participants||95% Confidence Interval|Number
2806182|NCT00477971|Secondary|Organ Response to Treatment|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|10 years||||percentage of participants||95% Confidence Interval|Number
2806183|NCT00477971|Secondary|3 Year Overall Survival|Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.|3 years||||percentage of participants||95% Confidence Interval|Number
2806184|NCT00477971|Primary|Hematologic Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response.~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response (VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response (PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|10 years||||percentage of participants||95% Confidence Interval|Number
2806185|NCT00477750|Secondary|Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3)|The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.|Every cycle during treatment up to 3 years|Patients who experienced an adverse event that is at least possibly related are included in this analysis.|||percentage of patients|||Number
2806186|NCT00477750|Secondary|Duration of Response (DOR)|Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.|from first response to progression or death (up to 3 years)|Phase 2 Patients who had a response of PR or better are included in this analysis.|||months||95% Confidence Interval|Median
2806187|NCT00477750|Secondary|Overall Survival (OS) at 3 Years|OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up. The overall survival at 3 years (a percentage) is reported below.|registration to death (up to 3 years)|Phase 2 patients.|||percentage of patients||95% Confidence Interval|Number
2806188|NCT00477750|Secondary|Progression-free Survival|"Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|registration to progressive disease (up to 3 years)|Phase 2 patients|||months||95% Confidence Interval|Median
2806189|NCT00477750|Primary|Patients With Overall Confirmed Response|"Response that was confirmed on 2 consecutive evaluations. >~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow >~Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours >~Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells"|Every cycle during treatment||||participants|||Number
2806190|NCT00477685|Primary|Preoperative and Postoperative Intraocular Pressure|The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.|baseline and 90 days||||mm Hg||Standard Deviation|Mean
2806191|NCT00477685|Secondary|Number of Participants With Any Complications or Adverse Events.|Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.|180 day||||participants|||Number
2806239|NCT00477464|Secondary|Trough Concentration of Lapatinib|PK samples were collected at pre-dose on Day 14 and Day 21 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose of lapatinib.|Week 2|ITT Population. Evaluable samples were not taken from some participants.|||ng/ml||Standard Deviation|Mean
2810054|NCT00450983|Secondary|Risk for Life-threatening Infections|Count of participants with life-threatening infections|Up to day 100||||Participants|||Count of Participants
2806192|NCT00477672|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Per Protocol population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received."|||Score on UPDRS-II+III||95% Confidence Interval|Least Squares Mean
2806193|NCT00477672|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug, and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment."|||Score on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
2806194|NCT00477633|Secondary|Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population|"Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain mean median duration of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated."|12 cycles (28 days each), approximately 336 days|MITT Population|||Days||Standard Deviation|Mean
2806195|NCT00477633|Secondary|Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population||12 cycles (28 days each), approximately 336 days|MITT Population|||Days||Standard Deviation|Mean
2806196|NCT00477633|Primary|Pearl Index, 18-35 Years, MITT Population|Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment|13 cycles (28 days each), approximately 364 days|MITT Population, Subjects Aged 18-35 years|||Pearl Index||95% Confidence Interval|Number
2806197|NCT00477607|Secondary|Total Amount of Prescribed Cisplatin Dose Administered|Maximum cumulative dose of cisplatin (mg/m^2) administered during the course of chemotherapy.|cisplatin treatment period between 10 weeks and up to 16 weeks.|Subjects from the original 39 recruited who had sufficient chemotherapy data recorded to measure cumulative dose.|||mg/m^2||Standard Deviation|Mean
2806198|NCT00477607|Secondary|Malondialdehyde (MDA) Levels|Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level.|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Non-missing MDA measurements from 23 subjects in primary outcome analysis|||uM=micro-moles/liter||Standard Deviation|Mean
2806199|NCT00477607|Primary|Ototoxicity Measurement|"Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement.~ASHA criteria are defined as~20 decibel (dB) increase at any test frequency,~10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies."|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Intent-to-treat (ITT)|||participants|||Number
2806200|NCT00477594|Other Pre-specified|High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806201|NCT00477594|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol|High-Density Lipoprotein (HDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806202|NCT00477594|Other Pre-specified|Apolipoprotein A1 Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806203|NCT00477594|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2810055|NCT00450983|Secondary|Risk for Graft Failure|Count of participant that had graft failure.|Engraftment documented day +20||||Participants|||Count of Participants
2806204|NCT00477594|Other Pre-specified|Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||ratio||Inter-Quartile Range|Median
2806205|NCT00477594|Other Pre-specified|Percent Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol||Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806206|NCT00477594|Other Pre-specified|Very-Low-Density Lipoprotein (VLDL) Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806207|NCT00477594|Other Pre-specified|Percent Change From Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol|Very-Low-Density Lipoprotein (VLDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806208|NCT00477594|Other Pre-specified|Lipoprotein(a) Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806209|NCT00477594|Other Pre-specified|Percent Change From Baseline in Lipoprotein(a)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806210|NCT00477594|Other Pre-specified|Triglycerides Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806211|NCT00477594|Other Pre-specified|Percent Change From Baseline in Triglycerides|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806212|NCT00477594|Secondary|Percent Change From Baseline in Respiratory Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set|||percentage of baseline||Standard Deviation|Mean
2806213|NCT00477594|Secondary|Percent Change From Baseline in Pulse Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set|||percentage of baseline||Standard Deviation|Mean
2806214|NCT00477594|Secondary|Percent Change From Baseline in Blood Pressure||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set|||percentage of baseline||Standard Deviation|Mean
2806215|NCT00477594|Secondary|Percent Change From Baseline in Hematology Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment|Safety set|||percentage of baseline||Standard Deviation|Mean
2806216|NCT00477594|Secondary|Percent Change From Baseline in Clinical Chemistry Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set.|||percentage of baseline||Standard Deviation|Mean
2806217|NCT00477594|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs were considered as related if assessed by the Investigator as possibly, probably or definitely related to study drug. The severity of each event was assessed using the following categories: Mild (symptom(s) barely noticeable to the patient or do not make the patient uncomfortable); Moderate (symptom(s) of a sufficient severity to make the patient uncomfortable, performance of daily activities is influenced) or Severe (symptom(s) of a sufficient severity to cause the patient severe discomfort, may cause cessation of treatment with the study drug). Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|2 years|Safety set|||participants|||Number
2810056|NCT00450983|Secondary|Risk for Mortality From Infection Before Day 180|Count of participant deaths from infection up to day 180.|Up to day 180||||Participants|||Count of Participants
2806218|NCT00477594|Secondary|Non-High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806219|NCT00477594|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806220|NCT00477594|Secondary|Total Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806221|NCT00477594|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806222|NCT00477594|Secondary|Apolipoprotein B Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806223|NCT00477594|Secondary|Percent Change From Baseline in Apolipoprotein B|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806224|NCT00477594|Primary|Low-density Lipoprotein Cholesterol (LDL-C) Over Time|Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||mg/dL||Inter-Quartile Range|Median
2806225|NCT00477594|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."|||percentage of baseline||Inter-Quartile Range|Median
2806226|NCT00477490|Secondary|Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Week 5 up to Day 169|Part II Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part II.|||participants|||Number
2806227|NCT00477490|Secondary|Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Day 1 up to Week 4 (end of Part I)|Part I Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part I.|||participants|||Number
2806228|NCT00477490|Secondary|Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4|The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
2806229|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4|The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
2806230|NCT00477490|Secondary|Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4|The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
2806231|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4|The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.|||units on a scale||Standard Deviation|Mean
2806232|NCT00477490|Secondary|Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4|Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|ITT population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants with both baseline and Week 4/Day 28/End of Part I data are included.|||minutes||Standard Deviation|Mean
2806233|NCT00477490|Secondary|Part I: Change From Baseline in Total Reported Sleep Time at Week 4|Total sleep time was recorded by participants in study diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants analyzed had baseline and Week 4/Day 28/End of Part 1 measurements.|||minutes||Standard Deviation|Mean
2806234|NCT00477490|Secondary|Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations. Participants had data representing the visit.|||percentage of participants|||Number
2806235|NCT00477490|Secondary|Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations.|||nocturnal voids||Standard Deviation|Mean
2806236|NCT00477490|Primary|Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4|"Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.~This was the second co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset|||percentage of participants|||Number
2806237|NCT00477490|Primary|Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4|"The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.~This was the first co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset|||nocturnal voids||Standard Deviation|Mean
2806251|NCT00477464|Secondary|Time to Response (Independent Reviewer-assessed)|Time to response is defined as the time from the start of treatment until the first documented evidence of complete response or partial response.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response|||weeks||95% Confidence Interval|Median
2806240|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 12 hours after dosing (AUC 0-12). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
2806241|NCT00477464|Secondary|AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
2806242|NCT00477464|Secondary|t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
2806243|NCT00477464|Secondary|Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
2806244|NCT00477464|Secondary|Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of drug. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.|||ng/ml||95% Confidence Interval|Geometric Mean
2806245|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 24 hour after dosing (AUC 0-24). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
2806246|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr*ng/ml||95% Confidence Interval|Geometric Mean
2806247|NCT00477464|Secondary|Terminal Elimination Half-life (t1/2) of Lapatinib|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
2806248|NCT00477464|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of lapatinib dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.|||hr||95% Confidence Interval|Geometric Mean
2806249|NCT00477464|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib|Pharmacokinetic (PK) samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hours (hr) (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of lapatinib.|Week 2|PK Population: consisted of the first six participants who were enrolled into the study and evaluable for the PK parameters of the investigational products. One participant was excluded due to dose reduction.|||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
2806250|NCT00477464|Secondary|Duration of Response (Independent Reviewer-assessed)|For the subset of participants who showed a complete or partial response, duration of response is defined as the time from the first documented evidence of partial or complete tumor response until the first documented sign of disease progression or death due to breast cancer, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response|||weeks||95% Confidence Interval|Median
2806311|NCT00477191|Secondary|Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.|Analyzing the safety and tolerability of Etanercept which is being measured through the number of adverse events related to Entanercept over a 6-month period.|6 months||||number of events|||Number
2806252|NCT00477464|Secondary|Overall Survival (Independent Reviewer-assessed)|Overall survival is defined as the time from the start of treatment until death regardless of cause. For participants who did not die, time to death was censored at the time of last confirmation of survival.|Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9)|ITT Population|||weeks||95% Confidence Interval|Median
2806253|NCT00477464|Secondary|Objective Response (Independent Reviewer-assessed)|Objective response is defined as the percentage of participants achieving a best overall response classified as a complete or partial (confirmed) tumor response. Complete response is defined as the disappearance of all target or non-target lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population|||percentage of participants|||Number
2806254|NCT00477464|Secondary|6-Month Progression-free Survival (Independent Reviewer-assessed)|6-Month progression-free survival is defined as the percentage of participants surviving without progressive disease at 6 months (24 weeks) after the start of treatment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Baseline and then every 6 weeks until Month 6 (Week 24)|ITT Population|||percentage of participants|||Number
2806255|NCT00477464|Secondary|Progression-free Survival (PFS) (Independent Reviewer-assessed)|PFS is defined as the interval between the start of treatment and the earliest date of disease progression or death of any cause, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population|||weeks||95% Confidence Interval|Median
2806256|NCT00477464|Secondary|Time to Progression (Independent Reviewer-assessed)|Time to progression is defined as the interval between the start of treatment and the earliest date of disease progression or death due to breast cancer, if sooner. Time to progression was calculated by using the Kaplan Meier estimate.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119)|ITT Population|||weeks||95% Confidence Interval|Median
2806257|NCT00477464|Primary|Clinical Benefit Response (Independent Reviewer-assessed)|"CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A complete response is defined as the disappearance of all target or non-target lesions, partial response and disease progression as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and stable disease as neither partial response nor disease progression."|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)|Intent-to-treat (ITT) Population: participants who had received at least one dose of study medication.|||percentage of participants|||Number
2806258|NCT00477451|Secondary|Borg Max Change From Baseline|"Subjects asked to Point to the number (0 to 10) which matches how breathless you feel now where 0=nothing at all to 10=very, very strong"|45 minutes|RCT Population (N=40)|||units on a scale||Standard Deviation|Mean
2806259|NCT00477451|Primary|Duration of the Doxapram-induced Panic Attack|Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)|1 hr post-dose|RCT Population (N=40)|||minutes||Standard Deviation|Mean
2806260|NCT00477451|Primary|Number of Participants With Doxapram-induced Panic Attack|doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)|0 to 2 hours|RCT Population (N=40)|||Participants|||Count of Participants
2806261|NCT00477386|Secondary|Phase II: Progression Free Survival|Progression free survival times will be estimated using the Kaplan-Meier method. If a patient progresses or dies, the time till that event will be used. If a patient does not progress or die on the study, the patient will be censored at the last available visit. Confidence intervals on the median will be constructed.|Baseline until disease progression or last visit|All Patients in Phase II of the study|||Months||95% Confidence Interval|Median
2806262|NCT00477386|Secondary|Phase II: Percent of Patients With Objective Response, CA125 Response or Stable Disease > 3 Months|The percent of patients having an objective response (Complete Response or Partial Response) or CA125 response (Complete Response or Partial Response) or stable disease > 3 months will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study|||percent of patients||95% Confidence Interval|Number
2806263|NCT00477386|Primary|Phase II: Percent of Patients With Objective Response|The percent of patients having an objective response (Complete Response or Partial Response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study|||percent of participants||95% Confidence Interval|Number
2806264|NCT00477386|Primary|Phase I: Maximum Tolerated Dose (MTD) for Use in Phase II|The definition of MTD will follow the standard definition of the phase I 3+3 trial concept. Dose Limiting Toxicities (DLTs) will be scored in the first cycle. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.|28 days|All patients assigned to Phase I of the study|||mg/m2 IV QD x 5 days|||Number
2806265|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment|"The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.~SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)"|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.|||Participants|||Number
2806266|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment|The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.|||Participants|||Number
2806267|NCT00477334|Secondary|Time to Second Recurrence of Genital Herpes|Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.|6 months|Intent to Treat Population: participants who completed the first recurrence.|||Days||Inter-Quartile Range|Median
2806268|NCT00477334|Secondary|Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period|Number of participants with a second recurrence of genital herpes in the follow-up period.|6 months|Intent to Treat Population: participants who completed the first recurrence.|||Participants|||Number
2806269|NCT00477334|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.|72 hour after initiation of study medication up to 21 days|Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis.|||Days||Inter-Quartile Range|Median
2806270|NCT00477334|Secondary|Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions|Kaplan-Meier estimation.|21 days|ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non aborted lesion stages and without a final assessment on aborted lesion status were assumed as having non aborted lesions in this analysis.|||Days||Inter-Quartile Range|Median
2806271|NCT00477334|Secondary|Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period||21 days|Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences.|||Percentage of Participants|||Number
2806272|NCT00477334|Primary|Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).|21 days|Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period.|||Days||Inter-Quartile Range|Median
2806273|NCT00477295|Secondary|Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1|The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score.|Week 31 through Week 83|Intent-to-Treat Population. This was measured using Observed Case (OC). The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score (n=174,196).|||Percentage of Participants|||Number
2806274|NCT00477295|Secondary|Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1|The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
2806275|NCT00477295|Secondary|Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1|"The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall~Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:~10 (Best possible quality of life) - 0 (Worst possible quality of life);~Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
2806276|NCT00477295|Secondary|Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1|"The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.~Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
2806340|NCT00476788|Primary|Mean Glycated Hemoglobin (A1c)|Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.|6.9 months (average)||||percentage of glycated hemoglobin||Standard Deviation|Mean
2806277|NCT00477295|Secondary|Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1|The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication. This was measured using Observed Case (OC).|||Scores on a Scale||Standard Deviation|Mean
2806278|NCT00477295|Secondary|Time to 12-months Seizure Freedom|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|ITT Population|||Days||Standard Deviation|Mean
2806279|NCT00477295|Secondary|Time to 6-months Seizure Freedom|A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|Intent-to-Treat (ITT) Population - randomized subjects who received at least one dose of study medication.|||Days||Standard Deviation|Mean
2806280|NCT00477295|Secondary|Analysis of Time to Drop Out Due to Lack of Efficacy|Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy.|Week 1 through Week 109|Per Protocol Population|||Median Days||Standard Error|Median
2806281|NCT00477295|Secondary|Analysis of Time to Drop Out Due to an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline.|Week 1 through Week 109|Per Protocol Population|||Median Days||Standard Error|Median
2806282|NCT00477295|Secondary|Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 109|Per Protocol Population. N=number of subjects with evaluable data.|||Percentage of participants|||Number
2806283|NCT00477295|Primary|Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase|A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 31 through Week 109|Per Protocol Population: All randomized subjects who received at least one dose of study medication and who had no major protocol violations.|||Percentage of Participants|||Number
2806284|NCT00477269|Secondary|Blood Gas Measurement - pH at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||pH scale||Standard Deviation|Mean
2806285|NCT00477269|Secondary|Blood Gas Measurement - Venous Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||percentage of saturation||Standard Deviation|Mean
2806286|NCT00477269|Secondary|Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||percentage of saturation||Standard Deviation|Mean
2806287|NCT00477269|Secondary|Blood Gas Measurement - PvO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806288|NCT00477269|Secondary|Blood Gas Measurement - PaCO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806289|NCT00477269|Secondary|Blood Gas Measurement - PaO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806341|NCT00476788|Secondary|Number of Reported Adverse Events|adverse events are defined as a change from baseline|6.9 months (average)||||events|||Number
2806342|NCT00476645|Secondary|Stable Disease After One Year|Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria.|12 months||||participants|||Number
2806290|NCT00477269|Secondary|Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta - Pright atrium)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||dyn*s/cm^5||Standard Deviation|Mean
2806291|NCT00477269|Secondary|Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP - PCWP)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||dyn*s/cm^5||Standard Deviation|Mean
2806292|NCT00477269|Secondary|Mean Cardiac Output (CO) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||L/min||Standard Deviation|Mean
2806293|NCT00477269|Secondary|Mean Heart Rate (HR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2806294|NCT00477269|Secondary|Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806295|NCT00477269|Secondary|Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806296|NCT00477269|Secondary|Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806297|NCT00477269|Secondary|Borg Score During the Six Minutes Walk Test at Different Time Periods|Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2806298|NCT00477269|Secondary|Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2806299|NCT00477269|Secondary|Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806300|NCT00477269|Secondary|Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
2806301|NCT00477269|Secondary|Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||Percentage of Oxygen Saturation||Standard Deviation|Mean
2806302|NCT00477269|Secondary|Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity|PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||number of participants|||Number
2806303|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||minutes||Standard Deviation|Mean
2806304|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||number of stops||Standard Deviation|Mean
2806305|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.|||meters||Standard Deviation|Mean
2806306|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|72 months|No formal statistical analysis was performed in the extension phase of this study so no analysis data sets were defined. All summaries are based on all patients enrolled.|||participants|||Number
2806307|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|6 months|Safety Population all participants enrolled was included in this population|||participants|||Number
2806308|NCT00477230|Primary|Freedom for Symptomatic Episode of Atrial Fibrillation at One Year||One Year|Early study termination before one year.|||participants|||Number
2806309|NCT00477204|Secondary|No Secondary Outcomes|No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.|6 months|||||||
2806310|NCT00477204|Primary|Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.|Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.|Baseline to 6 months|Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive.|||mg/dl||Standard Deviation|Mean
2806312|NCT00477191|Secondary|Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months|Reactive hyperemia index (RHI) is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction. The possible range of scores is 1 to 3 and a lower score has a worse outcome.|6 months||||units on a scale||Standard Deviation|Mean
2806313|NCT00477191|Secondary|Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.|6 months||||mg/dl||Standard Deviation|Mean
2806314|NCT00477191|Primary|Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome|6 months||||ng/mL||Standard Deviation|Mean
2806315|NCT00477165|Secondary|Urgency Score as a Function of Distending Pressure at the End of the Study|A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated urgency for bowel movement 30 seconds into each inflation. Urgency score scale: 0=no urgency, 1=threshold urgency, 5=worst imaginable urgency.|Week 8|Participants with available data were included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2806316|NCT00477165|Secondary|Mean Sensation Score as a Function of Distending Pressure at the End of the Study|A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second. After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated sensation 30 seconds into each inflation. Sensation score scale: 0=no inflation sensation, 1-5=increasing painless sensation, 6=threshold pain, 10=worst imaginable pain.|Week 8|Participants with available data were included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2806317|NCT00477165|Secondary|Change From Baseline in IBS-QOL Score at Week 8|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL consists of 34 statements about bowel problems, each with a five-point response scale ranging from 1 (no problems) to 5 (most problems). The individual scores are summed and averaged for a total score, then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life.|Baseline; Week 8||||units on a scale||95% Confidence Interval|Mean
2806318|NCT00477165|Primary|"Count of Participants Who Self-reported Adequate Relief"|Participants were asked weekly to answer subjectively whether weekly adequate relief from IBS symptoms was achieved. Overall response was defined as having achieved adequate relief in at least 3 of the past 6 weeks.|Baseline, weekly for 8 weeks||||Participants|||Count of Participants
2806319|NCT00477152|Secondary|Post-treatment Gorelick Dehydration Score|Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.|At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)|||No. moderate/severe symptoms (max = 10)||Standard Deviation|Mean
2806320|NCT00477152|Secondary|Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter||At end of placement of SC catheter|ITT (all treated patients)|||participants|||Number
2806321|NCT00477152|Primary|Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)|||participants|||Number
2806322|NCT00477152|Primary|HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)|||participants|||Number
2806323|NCT00477087|Secondary|Overall Survival (OS)|Assessed as the time from the 1st dose of study drug to death.|18 months||||Months||Full Range|Median
2806324|NCT00477087|Secondary|Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)|Defined as the first evidence of a total serum PSA decline of > 50% from baseline, maintained for at least 28 days, and confirmed with 2 consecutive measurements taken 2 weeks apart.|18 months||||Participants|||Count of Participants
2806325|NCT00477087|Primary|Progression-free Survival (PFS)|Assessed as the time from the 1st dose of study drug to death or disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS)|18 months||||weeks||Full Range|Median
2806326|NCT00476996|Secondary|Percentage of Participants With a Reduction in the HAQ-DI Score|Health Assessment Questionnaire - Disability Index (HAQ-DI): The Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA. It consists of 20 questions referring to eight component. Reduction in the HAQ-DI score of 0.25 units from baseline to weeks 24 and 48 represented a minimal clinically relevant improvement.|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2806343|NCT00476645|Secondary|PSA Doubling Time|Number of subjects with prolongation of PSA doubling time|3 months||||participants|||Number
2810057|NCT00450983|Primary|Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)|Count of participants with acute GVHD grades III-IV.|Up to day 100||||Participants|||Count of Participants
2806327|NCT00476996|Secondary|Percentage of Participants Achieving an ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, HAQ-DI and CRP.|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2806328|NCT00476996|Secondary|Percentage of Participants Achieving an ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, Health Assessment Questionnaire with Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2806329|NCT00476996|Secondary|Percentage of Participants With EULAR Response Rates of Good/ Moderate|The EULAR response rate was based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none.|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage|||Number
2806330|NCT00476996|Secondary|Change in DAS28 From Baseline|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2806331|NCT00476996|Secondary|Percentage of Participants Achieving Disease Activity Score (DAS28) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2806332|NCT00476996|Secondary|Percentage of Participants With a Major Clinical Response|Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.|Week 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2806333|NCT00476996|Primary|Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses|ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.|Weeks 24 and 48|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2806334|NCT00476957|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions|Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions|3 years||||participants|||Number
2806335|NCT00476957|Primary|To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation|Definite or probable stent thrombosis rate.|3 years||||participants|||Number
2806336|NCT00476827|Secondary|To Assess the Quality of Life During Treatment With This Therapeutic Approach|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks|||||||
2806337|NCT00476827|Primary|Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer|Due to slow accrual study was prematurely closed and endpoint not analysed|trial closure|Due to slow accrual study was prematurely closed and endpoint not analysed||||||
2806338|NCT00476827|Secondary|Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival.|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks|Due to slow accrual study was prematurely closed and endpoint not analysed||||||
2806339|NCT00476827|Primary|Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria.|Primary endpoint has not been analysed secondary to slow and low accrual numbers.|May 2009|Endpoint has not been analysed secondary to slow and low accrual numbers.||||||
2810058|NCT00450866|Secondary|Overall Survival|Median time (months) that patients survived during the duration of the study.|48 months from start of study|Intention to treat|||months||95% Confidence Interval|Median
2806345|NCT00476593|Primary|Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.|Macular thickness was assessed with the OCT in healthy subjects and in patients with anterior uveitis. Data was analyzed with respect to age, sex, parity, the use of hormonal therapy, after treatment with to types of anti-inflammatory eye drops, and in uncomplicated uveitis.|Macular thickness measured with the OCT|Enrolled healthy subjects and patients with anterior uveitis who volunteered through enrollment period|||Macular Thickness in micron||Standard Deviation|Mean
2806346|NCT00476476|Primary|Response Rate|Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).|Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).|The analysis dataset is comprised of response evaluable patients.|||proportion of participants||90% Confidence Interval|Number
2806347|NCT00476242|Secondary|Opiate Craving Based on Heroin Craving Scale|Range 0- 100 ( 0= no craving; 100= very strong craving|Average of twice weekly assessments for 12 weeks of study or length of participation||||units on a scale||Standard Deviation|Mean
2806348|NCT00476242|Primary|Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).||Week 12||||participants|||Number
2806349|NCT00476242|Primary|Opiate Use Measured by Urine Toxicology Results|Opiate use was qualified by the number of opiate positive urine results.|3x/week during 12 weeks of the trial or study participation||||Percent of total urine samples||Inter-Quartile Range|Median
2806350|NCT00476229|Primary|Composite Success Rate|Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Baseline to Day 100, assessment at Day 100|Analysis was per protocol. One participant was inevaluable.|||Percentage of participants|||Number
2806351|NCT00476151|Primary|Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.|diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.|baseline and 4 weeks treatment|ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation|||units on a scale||95% Confidence Interval|Least Squares Mean
2806352|NCT00476086|Secondary|Radiation Therapy Completion Rate|Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease|Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.|The analysis dataset is comprised of all participants who started chemotherapy.|||percentage of participants||90% Confidence Interval|Number
2806353|NCT00476086|Primary|Chemotherapy Completion Rate|Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.|3 cycles of chemotherapy which approximates 3 months given the 28-day cycle|The analysis dataset is comprised of all participants who started chemotherapy.|||percentage of participants||90% Confidence Interval|Number
2806354|NCT00476047|Secondary|Evaluate Toxicities of 131I-tositumomab|Adverse events following treatment of 131I-tositumomab|48 months (median)||||participants with this toxicity|||Number
2806355|NCT00476047|Primary|Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy||3 months after 131I-tositumomab consolidation||||Participants|||Count of Participants
2806356|NCT00476047|Primary|Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy|Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria. Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab.|3 months after 131I-tositumomab consolidation|Participants who had a partial response (PR) after initial chemotherapy. Response assessed using NCI working group guidelines + CT criteria as described in the protocol.|||Participants|||Count of Participants
2806357|NCT00476047|Primary|Probability of Progression-free Survival (PFS)|Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression. This outcome measures the percentage of participants with PFS at 36 months.|36 months||||percentage probability||95% Confidence Interval|Number
2806358|NCT00476021|Secondary|Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion||6 months||||participants|||Number
2806359|NCT00476021|Secondary|Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates||6 months||||participants|||Number
2806360|NCT00476021|Secondary|Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography||6 months|The population only includes women who received IUDs at the specified timepoint. Only 50/51 women in the postplacental group had a successful IUD insertion postplacentally. Only 46 of 51 women in the delayed group returned for a delayed IUD insertion.|||participants|||Number
2806361|NCT00476021|Secondary|Follow-up Rates for Delayed Insertion of LNG-IUD||6 months||||participants|||Number
2806362|NCT00476021|Secondary|Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement||6 months||||participants|||Number
2806363|NCT00476021|Primary|IUD Usage Rate at 6 Months|Usage rate of the LNG-IUD at 6 months after delivery|6 months after delivery|IUD use at 6 months, lost to follow-up counted as failures|||participants|||Number
2806364|NCT00476008|Secondary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
2806365|NCT00476008|Secondary|Cognitive Dementia Rating Scale|This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
2806366|NCT00476008|Secondary|Motor Free Visual Perception Test - Visual Closure Subtest|This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment.|baseline and 12 months||||number incorrect||Standard Deviation|Mean
2806367|NCT00476008|Secondary|Useful Field of View|The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
2806368|NCT00476008|Secondary|Mini Mental Status Exam|Scores range from 0-30 with lower scores indicating decreased functioning.|baseline and 12 months||||units on a scale||Standard Deviation|Mean
2806369|NCT00476008|Secondary|Trail Making Test - Part B|This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning.|baseline and 12 months||||seconds||Standard Deviation|Mean
2806370|NCT00476008|Secondary|Trail Making Test - Part A|A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.|baseline and 12 months||||seconds||Standard Deviation|Mean
2806371|NCT00476008|Secondary|Rey Complex Figure Test|This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment|baseline and 12 months||||units on a scale||Standard Deviation|Mean
2806372|NCT00476008|Secondary|Fuld Object Memory Evaluation|"Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity.~Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment."|baseline and 12 months||||units on a scale||Standard Deviation|Mean
2806373|NCT00476008|Primary|The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint).|The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles.|Baseline and 12 months|One subject in the placebo group could not complete the driving test at 12 months due to his vision being below the legal limit to drive.|||participants|||Number
2806374|NCT00475982|Secondary|Change in Percent Body Fat|This change in percent body fat is observed by DEXA, a scanner that measures total body composition.|baseline and post-intervention||||percentage of body fat||Standard Deviation|Mean
2806375|NCT00475982|Secondary|Change in Body Weight|This change in body weight is observed by DEXA, a scanner that measures total body composition.|baseline and post-intervention||||kg||Standard Deviation|Mean
2806376|NCT00475982|Secondary|Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells|The BRDU assay measures proliferation of cultured cells such as LNCaP. We expose the cells to the patient blood and see if it inhibits prostate cancer cell growth ex vivo. We use optical density (a measure of the amount of light able to pass through the specimen) to indicate the concentration of cell proliferation.|baseline and post-intervention||||density units||Standard Deviation|Mean
2806377|NCT00475982|Secondary|Change in Serum IGF-related Analytes: IGFBP-1|This outcome is the measure of the protein, insulin-like growth factor binding protein 1, at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this protein.|baseline and post-intervention||||ng/mL||Standard Deviation|Mean
2806378|NCT00475982|Secondary|Change in Serum IGF-related Analytes: IGF-1|This outcome is the measure of the hormone insulin-like growth factor 1 at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this hormone.|baseline and post-intervention||||ng/mL||Standard Deviation|Mean
2806379|NCT00475982|Secondary|Proliferative Index in Prostate Cancer Epithelium Specimen|The proliferative index in prostate cancer epithelium obtained from the radical prostatectomy specimen. This index was procured by staining the Ki67 protein to measure cell proliferation. (Note: Ki67 is a common indicator of cell proliferation.)|8 weeks||||percentage of cells stained||Standard Deviation|Mean
2806453|NCT00475423|Secondary|Change From Baseline in CD19 B Cell Count|Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day|Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.|||10^9 cells/L||Standard Deviation|Mean
2806380|NCT00475982|Primary|Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention|The primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss. The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade. TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample.|8 weeks||||percentage of cells stained||Standard Deviation|Mean
2806381|NCT00475904|Primary|Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin|Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline to 28 Days|Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique|||units on a scale||95% Confidence Interval|Least Squares Mean
2806382|NCT00475904|Primary|Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.|Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline and 28 days|This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.|||units on a scale||95% Confidence Interval|Mean
2806383|NCT00475878|Secondary|Depressive Symptoms|Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.|3 months|participants who were fully eligible for the study, completed the enrollment process and began study medication were included in an intent to treat analysis|||units on a scale||Standard Error|Mean
2806384|NCT00475878|Primary|Percentage of Participants Who Dropped Out of Buprenorphine Treatment|Drop-out is defined as 7 or more days of missed Buprenorphine doses|3 months|Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.|||percentage of participants|||Number
2806385|NCT00475865|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.|||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
2806386|NCT00475865|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group and region of enrollment as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||relapses per year||95% Confidence Interval|Number
2806387|NCT00475865|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters per scan|||Number
2806388|NCT00475865|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||lesions per scan||95% Confidence Interval|Number
2806389|NCT00475865|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters (mL)||Standard Error|Least Squares Mean
2806390|NCT00475865|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2810472|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48|Patients with a viral load of less than 400 copies/mL at Weeks 24 and 48 as measured from a plasma sample.|24 and 48 weeks|The trial has been stopped due to a poor enrollment||||||
2806391|NCT00475865|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly hair loss and hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2806392|NCT00475865|Primary|Overview of Adverse Events (AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
2806393|NCT00475852|Other Pre-specified|Number of Patients With Renal Impairment|Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.|Study drug initiation to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
2806394|NCT00475852|Other Pre-specified|Cardiovascular Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
2806395|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 180|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 180|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
2806396|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.|||Participants|||Number
2806397|NCT00475852|Secondary|Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806398|NCT00475852|Secondary|Number of Days Alive and Outside the Hospital||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Days||Standard Deviation|Mean
2806399|NCT00475852|Secondary|Composite of Persistent or Worsening Heart Failure and All-Cause Mortality|Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.|Randomization to hospital discharge (up to Day 30)|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806400|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806401|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806416|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment|"The AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.~Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment|||||||
2806402|NCT00475852|Primary|Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806403|NCT00475852|Primary|Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after initiation of study drug|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806404|NCT00475852|Primary|Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.|||Participants|||Number
2806405|NCT00475787|Secondary|Medical Outcome Study Short Form Physical Functioning Subscale|For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.|baseline and 5 weeks||||percentage of change||95% Confidence Interval|Mean
2806406|NCT00475787|Secondary|Performance of the Timed up and go Test|The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.|baseline and 5 weeks||||percentage of change||95% Confidence Interval|Mean
2806407|NCT00475787|Secondary|Oswestry Disability Index (ODI)|Validated measure of disability associated with lower back pain.|baseline and 5 weeks||||percentage of change||95% Confidence Interval|Mean
2806408|NCT00475787|Secondary|Medical Outcome Study Short Form 36(SF-36) Bodily Pain|For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.|baseline and 5 Weeks||||percentage of change||95% Confidence Interval|Mean
2806409|NCT00475787|Primary|Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)|"100 mm line with 0 being no pain and 100 mm being the worst pain I can imagine."|Baseline, 5 weeks||||percentage of change from baseline to 5||95% Confidence Interval|Mean
2806410|NCT00475735|Secondary|Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment|||||||
2806411|NCT00475735|Secondary|Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.|"Conners' Adult ADHD Rating Scale - Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with cue questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment|||||||
2806412|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score|"The Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.~Data not reported due to failure of primary hypothesis and program termination"|4 weeks of treatment|||||||
2806413|NCT00475735|Secondary|>/=1-point Improvement in the CGI-S Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment|||||||
2806414|NCT00475735|Secondary|>/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;|"The AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.~Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment|||||||
2806415|NCT00475735|Other Pre-specified|Baseline AISRS|"Baseline values for all treatment groups are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134-148)."|Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.|||score on scale||Standard Error|Least Squares Mean
2806417|NCT00475735|Primary|Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment|The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.|after 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.|||score on scale||95% Confidence Interval|Least Squares Mean
2806418|NCT00475722|Primary|Adherence to Dietary Goals|Percentage of participants who met 70% of diet goals as outlined in the exchange list|6 months||||percentage of participants meeting goals|||Number
2806419|NCT00475709|Primary|Characterize the Hemodynamic Performance of the Valve.|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.~Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.|||mm Hg||Standard Deviation|Mean
2806420|NCT00475709|Primary|Characterize Patient NYHA Functional Classification Status.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.|||percentage of participants|||Number
2806421|NCT00475709|Primary|Late Adverse Event Rates|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.~Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|Events occurring greater than or equal to 31 days post-implant.|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.|||percentage of events/late patient years|||Number
2806422|NCT00475670|Secondary|Overall Survival|The time, in months, from BL to death due to any cause.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
2806423|NCT00475670|Secondary|Overall Survival - Percentage of Participants Who Died|OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
2806424|NCT00475670|Secondary|Percentage of Participants With Clinical Benefit According to RECIST Guidelines|Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants||95% Confidence Interval|Number
2806425|NCT00475670|Secondary|Time to Treatment Failure|The time, in months, from BL to treatment failure.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
2806426|NCT00475670|Secondary|Percentage of Participants With Treatment Failure|Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
2806427|NCT00475670|Secondary|Progression-Free Survival|The time, in months, from BL to PFS event.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
2806428|NCT00475670|Secondary|Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease|PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
2806429|NCT00475670|Secondary|Duration of Response|The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||months||95% Confidence Interval|Median
2806430|NCT00475670|Secondary|Duration of Response - Percentage of Participants With Progressive Disease or Death|Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants|||Number
2806431|NCT00475670|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines|CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.|Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.|||percentage of participants||95% Confidence Interval|Number
2806432|NCT00475657|Secondary|Stable Disease Rate|Trial terminated - results not analyzed|baseline to measured progressive disease||||participants|||Number
2806433|NCT00475657|Secondary|Duration of Response|Trial terminated - results not analyzed|time of response to progressive disease||||months||Standard Deviation|Mean
2806434|NCT00475657|Secondary|Progression Free Survival|Trial terminated - results not analyzed|baseline to measured progressive disease||||participants|||Number
2806435|NCT00475657|Secondary|Overall Survival|Trial terminated - results not analyzed|baseline to date of death from any cause||||participants|||Number
2806436|NCT00475657|Primary|Overall Response Rate|Trial terminated - results not analyzed|baseline to measured progressive disease||||participants|||Number
2806437|NCT00475644|Secondary|Number of Participants With Response With Expression of Protein Biomarkers|Correlative analyses of tumor RR for PKC-β2 (protein kinase C-β) protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm reported as H scores (logistic model of response rate), which was derived from a weighted average of staining intensity (scale 0 to 3, increasing intensity) and percentage of positive cells (0 to 100%) at each staining intensity. PKC-β2 expression was further classified into high vs. low expression using the cutpoint of the median of the distribution of PKC-β2 H scores.|Baseline|The TR (Translational Research) population consisted of participants from whom tumor tissue was obtained.|||participants|||Number
2806438|NCT00475644|Secondary|Duration of Response (DoR)|DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease), DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date. For responding participants who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation anticancer therapy.|Time of Response to Measured Progressive Disease (Up to 1415 Days)|Participants who received at least 1 dose of study drug, did not violate any study entry criteria and had baseline and post-baseline response data. There were 4 censored participants.|||Days||95% Confidence Interval|Median
2810473|NCT00447902|Secondary|Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit|Virologic response defined as viral load less than 50 copies/mL|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
2806439|NCT00475644|Secondary|Time to Response (TtR)|TtR is defined as the time from the date of study enrollment to the date of response (CR, CRu, or PR) for patients who have responded prior to receiving any subsequent anticancer therapy.CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment; CRu, complete disappearance of all detectable clinical and radiographic evidence of disease, return of spleen to non-palpable if involved, residual lymph node mass greater than 1.5 centimeters (cm) has regressed by more than 75%; PR, 50% decrease in the sum of the products of the greatest diameter (SPD) of the 6 largest dominant masses, no increase of other nodes, liver or spleen and no new sites of disease.|Baseline to Date of Confirmed Response (Up to 890 Days)|Participants who received at least 1 dose of study drug and did not violate any study entry criteria and who had baseline and post-baseline response data.|||Days||95% Confidence Interval|Median
2806440|NCT00475644|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from the date of study enrollment to the first date of measured progressive disease or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation anticancer therapy. For reference, PFS will also be calculated and analyzed based on an alternative definition of censoring: for each patient who is not known to have died or to have had objective progression of disease as of the data cut-off date, PFS will be censored for that analysis at the date of last prior contact.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 1559 Days)|Participants who received at least 1 dose of study drug and who did not violate any study entry criteria. There were 18 censored participants.|||Days||95% Confidence Interval|Median
2806441|NCT00475644|Primary|Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])|Tumor response rate is defined as the number of responders divided by the number of treated patients. A responder is a patient who exhibits a complete response (CR), complete response unconfirmed (CRu), or partial response (PR) as defined by Cheson et al. CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment; CRu, complete disappearance of all detectable clinical and radiographic evidence of disease, return of spleen to non-palpable if involved, residual lymph node mass greater than 1.5 centimeters (cm) has regressed by more than 75%; PR, 50% decrease in the sum of the products of the greatest diameter (SPD) of the 6 largest dominant masses, no increase of other nodes, liver or spleen and no new sites of disease.|Baseline to Measured Progressive Disease (up to 1559 Days)|Participants who received at least 1 dose of study drug and did not violate any study criteria.|||percentage of participants||95% Confidence Interval|Number
2806442|NCT00475501|Secondary|Life Satisfaction|Life Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction.|baseline, 3 months, 6 months, 9 months, 12 months||||points||Standard Error|Mean
2806443|NCT00475501|Secondary|Transrectal Ultrasound Sizing of Prostate|Transrectal ultrasound sizing of prostate will be performed using the B&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment.|baseline, 6 month, 12 months||||cc||Standard Error|Mean
2806444|NCT00475501|Secondary|Dietary Protein Intake|"Dietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide Healthy Ways to Eat More Protein."|baseline, 3 months, 6 months, 9 months, 12 months||||gm/body weight (kg)||Standard Error|Mean
2806445|NCT00475501|Secondary|Hematocrit|Hematocrit was assessed as a part of routine blood analysis at the indicated time points.|baseline, 3 months, 6 months, 9 months, 12 months||||% volume||Standard Error|Mean
2806446|NCT00475501|Secondary|Benton Judgment of Line Orientation Test|"Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition"|baseline, 3 months, 6 months, 9 months, 12 months||||units on a scale||Standard Error|Mean
2806447|NCT00475501|Secondary|Trail-Making Test, Part A|Trail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27.|baseline, 3 months, 6 months, 9 months, 12 months||||sec||Standard Error|Mean
2806448|NCT00475501|Secondary|30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test|"Rey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning.~The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing."|baseline, 3 months, 6 months, 9 months, 12 months||||units on a scale||Standard Error|Mean
2806449|NCT00475501|Secondary|Geriatric Depression Scale|"Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms"|baseline, 3 months, 6 months, 9 months, 12 months||||units on a scale||Standard Error|Mean
2806450|NCT00475501|Secondary|Lumbar Spine L2-L4 Bone Mineral Density|Dual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems).|baseline, 12 months||||gm/cc||Standard Error|Mean
2806451|NCT00475501|Secondary|Grip Strength kg|Grip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment.|baseline, 3 months, 6 months, 9 months, 12 months||||kg||Standard Error|Mean
2806455|NCT00475423|Secondary|Percentage of Participants With a Therapeutic Response|Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population|||percentage participants||95% Confidence Interval|Number
2806456|NCT00475423|Secondary|Percentage of Therapeutic Responders|Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population|||percentage of participants|||Number
2806457|NCT00475423|Secondary|Time to Initiation of New ITP Therapy|Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
2806458|NCT00475423|Secondary|Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event|Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Week 52|ITTR Population|||percentage of participants|||Number
2806459|NCT00475423|Secondary|Duration of MR in Participants With Continued MR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population|||days||95% Confidence Interval|Median
2806460|NCT00475423|Secondary|Duration of PR in Participants With Continued PR From Week 8 Until Week 52|Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population|||days||95% Confidence Interval|Median
2806461|NCT00475423|Secondary|Duration of CR in Participants With Continued CR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.|||days||95% Confidence Interval|Median
2806462|NCT00475423|Secondary|Percentage of Participants With Continued CR From Week 8 to Week 52|The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.|||percentage of participants|||Number
2806463|NCT00475423|Secondary|Time to MR|Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
2806464|NCT00475423|Secondary|Percentage of Participants Who Achieved MR|MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population|||percentage of participants|||Number
2806465|NCT00475423|Secondary|Time to PR|Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
2806466|NCT00475423|Secondary|Percentage of Participants Who Achieved PR|PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population|||percentage of participants|||Number
2806467|NCT00475423|Secondary|Time to CR|Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.|Baseline to Week 52|ITTR Population|||days||95% Confidence Interval|Median
2806469|NCT00475423|Secondary|Percentage of Participants With Hematological CR, PR, or Minor Response (MR)|Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.|Week 8|ITTR Population|||percentage of participants||95% Confidence Interval|Number
2806470|NCT00475423|Primary|Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)|Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.|Week 8|Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10^9/L within 7 days prior to 1st rituximab infusion.|||percentage of participants||95% Confidence Interval|Number
2806471|NCT00475332|Secondary|The Secondary Endpoint Will be to Assess Response Rates and Patterns of Failure in Patients Treated With Bexxar and External Beam Radiotherapy (EBRT).|Tumor response to treatment is measured using the RECIST criteria: Response Evaluation Criteria in Solid Tumors which defines Complete Response, Partial Response, Progressive Disease, and Stable Disease, by using tumor measurements as seen on CT or MRI|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.|||Participants|||Number
2806472|NCT00475332|Primary|The Primary Endpoint of the Study Will be to Determine the Feasibility of Combining External Beam Radiotherapy (EBRT) and Bexxar by Assessing the Toxicities Associated With the Treatment.|13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.|||Participants|||Number
2806473|NCT00475319|Secondary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared.|Baseline, 4weeks||||LGCS score||Standard Deviation|Mean
2806474|NCT00475319|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-15). 0 is better.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 4weeks||||FCS score||Standard Deviation|Mean
2806475|NCT00475306|Secondary|Number of Participants With Akathisia|The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see participant flow for details|||participants|||Number
2806476|NCT00475306|Primary|Nausea Scale|Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details.|||units on a scale||Inter-Quartile Range|Median
2806477|NCT00475241|Secondary|Posttraumatic Cognitions Inventory|Self-report measure of trauma-related cognitions. Range is 21-147. Higher is more problematic trauma-related cognitions.|PostTreatment (Week 12)|patients with missing data not included|||units on a scale||Standard Deviation|Mean
2806478|NCT00475241|Secondary|Cortisol Response to Awakening|"Area under the curve for awakening, 30 min, and 45 minute salivary cortisol assays.~Higher means more cortisol response to awakening detected."|PostTreatment (Week 12)|Patient assay quality not adequate for some patients|||min*mg/mL||Standard Deviation|Mean
2806479|NCT00475241|Secondary|Trauma Potentiated Startle|"Psychophysiological reactivity will be assessed using electromyography collected using a Biopac MP-100 physiology. The potentiation is recorded using a difference score (trauma probe response minus non-trauma probe response).~The unit of measure is µV. Higher is more response to trauma cue compared to non-trauma cue."|PostTreatment (Week 12)|data was not available due to recording errors for some patients|||µV||Standard Deviation|Mean
2806480|NCT00475241|Primary|Clinician Administered PTSD Scale (Pre & Posttreatment)|Clinician Administered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.|PostTreatment (Week 12)|Treatment Completers|||units on a scale||Standard Deviation|Mean
2806481|NCT00475228|Secondary|To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion|Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group|6 months|3 of the 44 participants who had the LNG-IUD placed in Arm 1 underwent an IUD expulsion. 1 of the 20 participants who had the LNG-IUD placed in Arm 2 underwent an IUD expulsion.|||percentage of participants|||Number
2806482|NCT00475228|Secondary|To Examine the Number of Women Receiving the LNG-IUD in Each Group|The difference between the overall number of women who had the LNG-IUD inserted immediately post D&E successfully (Arm 1) was compared to the overall number of women who had the LNG-IUD inserted 3 -6 weeks post D&E (standard or routine) (Arm 2).|2 Months|In Arm 1, all 44 participants were inserted with an LNG-IUD immediately post D& E successfully. In Arm 2; only 20 of the 44 participants returned and had the LNG-IUD inserted successfully 3 to 6 weeks post D&E.|||Completed LNG-IUD Insertions|Completed LNG-IUD Insertions||Number
2806483|NCT00475228|Primary|The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.|"To assess the six-month usage rate of the LNG-IUD when placed immediately after D&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D&E.~We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than women receiving delayed insertion."|6 months|Attempts to contact all participants (Arm 1: 44 women and Arm 2: 44 women) by phone 6 months post D&E were made. For Arm 1, 27 out of 44 women could be reached. For Arm 2; 27 out of the 44 were reached (19 women who returned and had the LNG-IUD placed 3-6 weeks post D&E and 8 women who did not return for the LNG-IUD placement 3-6 post D&E).|||percentage of participants||95% Confidence Interval|Number
2806484|NCT00475215|Secondary|General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room|Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.|Up to 6 hours (prior to discharge from the recovery room)|All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.|||Participants|||Count of Participants
2806485|NCT00475215|Secondary|General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation|Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.|Up to 6 hours (prior to transfer to the recovery room after extubation)|All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.|||Participants|||Count of Participants
2806486|NCT00475215|Secondary|Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room|The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.|Up to 6 hours (prior to discharge from the recovery room)|All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.|||Participants|||Count of Participants
2806487|NCT00475215|Secondary|Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation|The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.|Up to 6 hours (prior to transfer to the recovery room after extubation)|All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.|||Participants|||Count of Participants
2806488|NCT00475215|Secondary|Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room|The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.|Up to 6 hours (prior to discharge from the recovery room)|All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure.|||Participants|||Count of Participants
2806489|NCT00475215|Secondary|Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation|The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.|Up to 6 hours (prior to transfer to the recovery room after extubation)|All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure. One participant in the 4.0 mg/kg group had missing data.|||Participants|||Count of Participants
2806490|NCT00475215|Secondary|Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease|The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.|Up to 90 minutes|All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 7 participants (2.0 mg/kg n=4 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=5).|||Minutes||Standard Deviation|Mean
2806491|NCT00475215|Secondary|Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease|The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.|Up to 90 minutes|All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 6 participants (2.0 mg/kg n=3 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=4).|||Minutes||Standard Deviation|Mean
2806492|NCT00475215|Primary|Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)|The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 7 days|All randomized participants who received sugammadex are included.|||Percentage of Participants|||Number
2806493|NCT00475215|Primary|Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)|The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 7 days|All randomized participants who received sugammadex are included.|||Percentage of Participants|||Number
2806494|NCT00475215|Primary|Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease|The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.|Up to 90 minutes|All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 11 participants (2.0 mg/kg n=6 and 4.0 mg/kg n=5), data were missing due to watch malfunction (n=2), the data that was obtained was considered unreliable (n=6), or the watch was removed prior to recovery to 0.9 (n=3).|||Minutes||Standard Deviation|Mean
2806495|NCT00475176|Secondary|2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).|2-log decline in HCV RNA by week 12 (early virological response) and sustained eradication of HCV RNA (sustained virological response).|12 weeks from start of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.|||participants|||Number
2806496|NCT00475176|Primary|Improvement in Viral Kinetics During the First 2 Weeks of Therapy|Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy|Days 7 to 14 of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.|||participants|||Number
2806497|NCT00475150|Secondary|The Number of Patients That Report Adverse Events Possibly, Probably, or Definitely Related to AZD2171.|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All adverse events determined to be possibly, probably, or definately related to AZD2171 are included in this analysis.|Continuously during treatment up to 26 courses|All participants were analyzed for this endpoint.|||participants|||Number
2806498|NCT00475150|Secondary|Duration of Response|Measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Estimated using the method of Kaplan-Meier.|Every 3 courses up to 26 courses|This endpoint was not analyzed due to lack of response.||||||
2806499|NCT00475150|Secondary|Progression-free Survival|"Defined as the time from date of registration to date that disease progression was documented, death, or last date that progression-free status was documented, whichever comes first. Estimated using the method of Kaplan-Meier.~Disease progression is defined as one of the following:~A ≥ 50% increase in bone marrow blasts from the best response, or~A 50% or greater decrement from maximum remission/response levels in neutrophils or platelets, or~A reduction in hemoglobin concentration by at least 1.5 g/dl, or~Transfusion dependence (without alternative explanation and sustained for at least 2 weeks)."|Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment|All participants are evaluable for this primary endpoint.|||months||95% Confidence Interval|Median
2806500|NCT00475150|Secondary|Overall Survival|Defined as the time from date of registration to date of death due to any cause or date last known alive. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Every cycle during treatment and every 6 months for up to 2 years after completion of study treatment|All participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2806501|NCT00475150|Primary|The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations.|"Complete Response (CR) requires a repeat bone marrow with < 5% myeloblasts, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.~Partial Response (PR) requires a bone marrow blast reduction of 50% or more, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.~Hematologic Improvement (HI) requires one of the following:~RBC transfusion independent participants are required to have >1.5 g/dL increase in hemoglobin,~RBC transfusion-dependent participants are required to be transfusion independent,~A 100% increase, and an absolute increase over 500mm^3 in Absolute Neutrophil Count,~Participants with a pretreatment platelet count over 20,000/mm3 require an absolute increase of 30,000/mm^3 or more,~Participants with platelet count below 20,000/mm3 require an increase over 20,000/mm^3 and by at least 100%."|At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles|All participants were evaluable for this endpoint.|||participants|||Number
2806503|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806504|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806505|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806506|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806507|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806508|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806509|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806510|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.|||percentage of subjects|||Number
2806511|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration (titer) to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
2806520|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the toddler dose of NeisVac-C® (13 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-toddler dose antibody concentration (titer) to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
2806512|NCT00475033|Primary|Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMC µg/mL||95% Confidence Interval|Geometric Mean
2806513|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
2806514|NCT00475033|Primary|Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose Infant Series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMC EU/mL||95% Confidence Interval|Geometric Mean
2806515|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.|||GMC μg/mL||95% Confidence Interval|Geometric Mean
2806516|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.|||percentage of subjects||95% Confidence Interval|Number
2806517|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.|||GMC μg/mL||95% Confidence Interval|Geometric Mean
2806518|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.|||percentage of subjects||95% Confidence Interval|Number
2806519|NCT00475033|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMT||95% Confidence Interval|Geometric Mean
2806521|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.|||percentage of subjects||95% Confidence Interval|Number
2806522|NCT00475033|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|||GMT||95% Confidence Interval|Geometric Mean
2806523|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.|||percentage of subjects||95% Confidence Interval|Number
2806524|NCT00475020|Secondary|Efficacy of This Therapy 3 Years Post-transplant|Efficacy Assessed as Number of Participants with Overall Survival, Leukemia Progression, Primary Graft Failure and Complete Hematological Response. Primary graft failure is defined as failure to achieve an ANC >/= 0.5 x 10 (9)/L for 3 consecutive days and evidence of donor chimerism by Day +28. Complete hematological response is defined by hemoglobin >/= 120 g/L; or achievement of transfusion independence, with stable Hb > 110 g/L, for RBC transfusion-dependent participants; Spleen not palpable; platelet count 150 x 10 (9)/L; White blood cell 4 x 10 (9)/L to 10 x 10(9)/L.|Up to 3 years post-transplant||||Participants|||Count of Participants
2806525|NCT00475020|Primary|Rate of Non-relapse Mortality at 100 Days Post-transplant|To evaluate the safety of Fludarabine/Busulfan as conditioned regimen for allogeneic stem cell transplantation in patients with myelofibrosis/myelodysplastic syndrome at 100 days post-transplant|Non-relapse mortality at 100 days post-transplant||||Participants|||Count of Participants
2806526|NCT00474994|Primary|Overall Objective Response|as assessed by RECIST criteria|2 years||||participants|||Number
2806527|NCT00474968|Primary|Specimen Adequacy|Number and percentage of samples classified as adequate for diagnosis|At time of cell collection|Includes all cytology specimens|||Participants|||Number
2806528|NCT00474968|Secondary|Human Papilloma Virus (HPV) Detection Frequency|Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay|At the time of cell collection.||||Participants|||Number
2806529|NCT00474968|Primary|Cell Collection Efficacy|True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.|At the time of cell collection.|79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported|||Participants|||Number
2806530|NCT00474955|Secondary|Mean Change From Baseline in Heart Rate up to Week 72|Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.|||Beats per minute (bpm)||Standard Deviation|Mean
2806531|NCT00474955|Secondary|Mean Change From Baseline in Blood Pressure up to Week 72|Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.|||Millimeter (mm) of Mercury||Standard Deviation|Mean
2806532|NCT00474955|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks|Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|Up to Week 72|ITT population included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2806533|NCT00474955|Secondary|Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks|Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.|Up to Week 48|ITT population included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
2806534|NCT00474955|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Week 72|Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.|||Participants|||Number
2806535|NCT00474955|Primary|Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline|The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).|From Baseline (Days -30 to -1) and Week 24|ITT population included all enrolled participants who received at least one dose of study medication.|||Percentage of participants|||Number
2806536|NCT00474955|Primary|Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48|HCV RNA level less than 50 IU/mL was considered to be undetectable.|At Week 24 and Week 48|ITT population included all enrolled participants who received at least one dose of study medication.|||Percentage of participants|||Number
2806537|NCT00474955|Primary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion|Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).|At Week 72|ITT population included all enrolled participants who received at least one dose of study medication.|||Percentage of participants|||Number
2806538|NCT00474929|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date documentation of disease progression or death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
2806539|NCT00474929|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
2806540|NCT00474929|Primary|Proportion of Confirmed Tumor Responses|"A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12.~Complete Response (CR):~Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio.~Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly.~Partial Response (PR):~MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma.~Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline."|Up to 12 cycles of treatment||||percentage of participants|||Number
2806541|NCT00474929|Primary|Number of Participants Reporting a Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria:~Grade 4 infection~Grade 4 ANC or PLT~Grade 3 or higher non-hematologic adverse event.~NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated."|First cycle (28 days) of study treatment||||participants|||Number
2806542|NCT00474903|Secondary|Toxicity|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the interventional agent, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of patients reporting adverse events will be tabulated by grade.|Up to 30 days after completion of study treatment|All 120 patients that took study medication were evaluable for this secondary endpoint.|||participants|||Number
2806543|NCT00474903|Primary|Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples|The mean tissue PGE2 is reported for each Arm.|Baseline to 30 days after completion of study treatment||||pg/mL||Standard Deviation|Mean
2806544|NCT00474851|Secondary|Total Body Bone Mineral Content (BMC)||Baseline to 12 months||||g||Standard Error|Mean
2806545|NCT00474851|Primary|Bone Mineral Density|Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial|Baseline to 12 months||||g/cm^2||Standard Error|Mean
2806546|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|at 8 weeks|Participants who were ambulatory at 8 weeks|||meters per second||Standard Error|Mean
2806547|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|baseline|Participants who were ambulatory at baseline|||meters per second||Standard Error|Mean
2806548|NCT00474812|Secondary|Median Progression Free Survival (PFS)|Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.|Up to 5 years|Intent to treat|||months||95% Confidence Interval|Median
2806549|NCT00474812|Secondary|Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee|Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.|Up to 5 years|Patients that reached first scans at 2 months|||participants|||Number
2806550|NCT00474812|Primary|Median Overall Survival|From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months|assessed up to 24 months|Intent to treat.|||months||95% Confidence Interval|Median
2806551|NCT00474786|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 24 months|Safety population: all participants who received at least 1 dose of test article.|||participants|||Number
2806552|NCT00474786|Secondary|Duration of Response (DR)|Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.|Baseline up to 24 Months|ITT population|||months||95% Confidence Interval|Median
2806553|NCT00474786|Secondary|Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment|PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.|Weeks 12, 24, and 36|ITT population|||percentage of participants|||Number
2806554|NCT00474786|Secondary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death from any cause (up to 24 months)|ITT population|||months||95% Confidence Interval|Median
2806555|NCT00474786|Secondary|Percentage of Participants With Tumor Response|Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline up to 24 Months|ITT population|||percentage of participants||95% Confidence Interval|Number
2806556|NCT00474786|Secondary|Progression Free Survival (PFS) by Investigator Assessment|Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.|Baseline up to 24 Months|ITT population|||months||95% Confidence Interval|Median
2806557|NCT00474786|Primary|Progression-Free Survival (PFS)|Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.|Baseline up to 24 Months|Intent to Treat Population (ITT): all randomized participants according to their assigned treatment, regardless of whether they were received any study drug.|||months||95% Confidence Interval|Median
2806558|NCT00474760|Secondary|Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs|Quantification of IGF-IR positive CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.||||||
2806559|NCT00474760|Secondary|Number of Circulating Tumor Cells (CTCs)|Quantification of CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.||||||
2806560|NCT00474760|Secondary|Human Anti-human Antibodies (HAHA) Levels|HAHA were indicators of immunogenicity to figitumumab.|30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)|Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA.||||||
2806561|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure|||mg*hr/L||Standard Deviation|Mean
2806562|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure|||mg*hr/L||Standard Deviation|Mean
2806563|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
2810504|NCT00447590|Secondary|Subject Percent Excess BMI Loss|Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60|||kg/m2||95% Confidence Interval|Mean
2806564|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
2806565|NCT00474760|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1|Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
2806566|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg*hr/L||Standard Deviation|Mean
2806567|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milligram*hour/liter (mg*hr/L)||Standard Deviation|Mean
2806568|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/kg||Standard Deviation|Mean
2806569|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/kg||Standard Deviation|Mean
2806570|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/kg||Standard Deviation|Mean
2806571|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milliliter/kilogram (mL/kg)||Standard Deviation|Mean
2806572|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg/L||Standard Deviation|Mean
2806573|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg/L||Standard Deviation|Mean
2806574|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mL/day/kg||Standard Deviation|Mean
2806575|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
2806576|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
2806577|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
2806578|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
2806579|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
2806580|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
2806581|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||hours||Standard Deviation|Mean
2806582|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||mg/L||Standard Deviation|Mean
2806583|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.|||milligram/liter (mg/L)||Standard Deviation|Mean
2806584|NCT00474760|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 150 days after the last administration of study drug|All enrolled participants who started treatment.|||participants|||Number
2806585|NCT00474708|Secondary|Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. A total of 125 (VEN XR=83, SSRI=42) patients had a co-morbid anxiety disorder and 834 (VEN XR=581, SSRI=253) did not.|||participants|||Number
2806586|NCT00474708|Primary|Number of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment.|||participants|||Number
2806601|NCT00474630|Secondary|Percent of Subjects With Dose Reduction in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806602|NCT00474630|Secondary|Percent of Subjects Requiring Rescue Medications for Diabetes||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806587|NCT00474630|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2806588|NCT00474630|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2806589|NCT00474630|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2806590|NCT00474630|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
2806591|NCT00474630|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mm Hg||Standard Error|Least Squares Mean
2806592|NCT00474630|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2806593|NCT00474630|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2806594|NCT00474630|Secondary|Percent of Subjects Discontinuing Due to Poor Glycemic Control|Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed. Odds ratio not calculated as there were no subjects in the NB32 group that discontinued due to poor glycemic control.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806595|NCT00474630|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2806596|NCT00474630|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2806597|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <6.5% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806598|NCT00474630|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2806599|NCT00474630|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2806600|NCT00474630|Secondary|Percent of Subjects With Dose Increase in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806604|NCT00474630|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806605|NCT00474630|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
2806606|NCT00474630|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2806607|NCT00474630|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2806608|NCT00474630|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2806609|NCT00474630|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2806610|NCT00474630|Secondary|Change in HbA1c Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent||Standard Error|Least Squares Mean
2806611|NCT00474630|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
2806612|NCT00474617|Secondary|Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room|Participants were asked to lift their head off the table while in a supine position just prior to discharge from the recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment.|Prior to Discharge from Recovery Room (up to 24 hours)|All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.|||Participants|||Number
2806613|NCT00474617|Secondary|Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation|Participants were asked to lift their head off the table while in a supine position post-extubation and prior to transfer to recovery room. The number of participants who could perform the 5 second head lift was summarized. Participants who were not cooperative with the examination were not included in the assessment.|Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)|All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.|||Participants|||Number
2806614|NCT00474617|Secondary|Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room|"The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade prior to discharge from the recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as yes or no to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment."|Prior to Discharge from Recovery Room (up to 24 hours)|All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.|||Participants|||Number
2806615|NCT00474617|Secondary|Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation|"The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade post-extubation and prior to transfer to recovery room. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups and the overall assessments were reported as yes or no to general muscle weakness. Participants who were not cooperative with the examination were not included in the assessment."|Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)|All participants that received study drug, had at least 1 post-baseline efficacy measurement and were determined to be cooperative.|||Participants|||Number
2806616|NCT00474617|Secondary|Participants Level of Consciousness Prior to Discharge From Recovery Room|Participants level of consciousness was assessed prior to discharge from the recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized.|Prior to Discharge from Recovery Room (up to 24 hours)|All participants that received study drug and had at least 1 post-baseline efficacy measurement and had data available for endpoint|||Participants|||Number
2806617|NCT00474617|Secondary|Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation|Participants level of consciousness was assessed post-extubation and prior to transfer to recovery room. The levels were reported as: awake and oriented; arousable with minimal stimulation; responsive only to tactile stimulation. The number of participants in each of the 3 categories was summarized.|Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)|All participants that received study drug, had at least 1 post-baseline efficacy measurement and had data available for endpoint.|||Participants|||Number
2810994|NCT00444275|Secondary|Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase|No possibility to describe as only 2 patients took ASA|4 weeks|Outcome measure not possible to describe as only 2 patients took Aspirin.||||||
2806618|NCT00474617|Secondary|Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.|up to 10 minutes from start of sugammadex|All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed.|||Minutes||Standard Deviation|Mean
2806619|NCT00474617|Secondary|Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.|up to 10 minutes from start of sugammadex|All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed.|||Minutes||Standard Deviation|Mean
2806620|NCT00474617|Primary|Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.|up to 10 minutes from start of sugammadex|All participants that received study drug and had at least 1 post-baseline efficacy measurement. Missing data were imputed.|||Minutes||Standard Deviation|Mean
2806621|NCT00474539|Secondary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after toddler dose (at 16 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
2806622|NCT00474539|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2806623|NCT00474539|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2806624|NCT00474539|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose||One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2806625|NCT00474539|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose|Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).|One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2806626|NCT00474539|Primary|Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose||One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)|The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2811764|NCT00439374|Secondary|Median Length of NICU Stay|Median length of stay in the neonatal intensive care unit in days|NICU admission through NICU discharge|Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.|||days||Inter-Quartile Range|Median
2806627|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2806628|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2806629|NCT00474539|Primary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series|Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after infant series dose (at 5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.|||percentage of participants||95% Confidence Interval|Number
2806630|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806631|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806632|NCT00474526|Secondary|Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
2806633|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
2806634|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F|13 months of age (one month post-toddler vaccination)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
2806635|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol|||Concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
2806636|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
2806637|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
2806638|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806639|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806640|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2811765|NCT00439374|Secondary|Number of Neonates Admitted to NICU|Admission to the neonatal intensive care unit|Delivery through hospital discharge|Data was missing for 5 participants in the treatment group and 1 participant in the placebo group.|||Participants|||Count of Participants
2806641|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806642|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806643|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806644|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806645|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806646|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806647|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806648|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806649|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers - US Subject|Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.|12 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806650|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"|||Percentages of subjects||95% Confidence Interval|Number
2806651|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"|||Percentages of subjects||95% Confidence Interval|Number
2806652|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
2806653|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
2806654|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Percentages of subjects||95% Confidence Interval|Number
2806655|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol|||Titers||95% Confidence Interval|Geometric Mean
2812609|NCT00433771|Secondary|Time to Stent Occlusion|Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.|Until 6 Months or death|Only 1 subject experienced stent occlusion during the study.|||Days|||Number
2806656|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806657|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population|||Percentages of subjects||95% Confidence Interval|Number
2806658|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population|||Percentages of subjects||95% Confidence Interval|Number
2806659|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population|||Percentages of subjects||95% Confidence Interval|Number
2806660|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.|7 months of age (one month post-infant series)|Per protocol population|||Titer||95% Confidence Interval|Geometric Mean
2806661|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - US Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806662|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series|Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis.|||Subjects|||Number
2806663|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series|Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis.|||Subjects|||Number
2806664|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series|Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
2806665|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series|Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis.|||Subjects|||Number
2806666|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series|Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
2806667|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age|Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
2806668|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series|Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.|||Subjects|||Number
2806669|NCT00474526|Primary|Geometric Mean hSBA Titers - US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2806670|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series|Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age.|||Subjects|||Number
2806671|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series|Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed.|||Subjects|||Number
2806672|NCT00474526|Primary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age|13 months of age (one month post-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"|||Percentages of subjects||95% Confidence Interval|Number
2806673|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years|Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).|Days 1 to 7|The analysis was done on the safety population.|||Subjects|||Number
2806674|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years|Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).|Days 1 to 7|The analysis was performed on the safety population.|||Subjects|||Number
2806675|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2806676|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2806677|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).~Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
2806678|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).~Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Number
2806679|NCT00474487|Primary|Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years|Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.|Days 1 to 7|The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.|||Subjects|||Number
2806680|NCT00474383|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)|The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study.|||participants|||Number
2806681|NCT00474383|Secondary|Overall Survival|Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Baseline until death, or end of study (Week 148)|The ITT population included all the participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2806694|NCT00474266|Secondary|Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0|Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.|During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2806682|NCT00474383|Secondary|Progression Free Survival Time|Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.|||days||95% Confidence Interval|Median
2806683|NCT00474383|Secondary|Duration of PSA Response|Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2806684|NCT00474383|Secondary|Time to PSA Progression|The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2806685|NCT00474383|Secondary|Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)|The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.|Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.|||percentage of participants||95% Confidence Interval|Number
2806686|NCT00474383|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline up to Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
2806687|NCT00474383|Primary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline, Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
2806688|NCT00474266|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From Day 0 up to Month 6 after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2806689|NCT00474266|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 43-day (Days 0-42) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2806690|NCT00474266|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 43-day (Days 0-42) post Dose 1 vaccination period|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects.|||Participants|||Count of Participants
2806691|NCT00474266|Secondary|Number of Subjects Reporting Specific Adverse Events (AEs)|Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.|From Day 0 up to Month 6 after first vaccine dose|The analysis was performed on the Total Vaccinated Cohort (TVC ), which included all vaccinated subjects.|||Participants|||Count of Participants
2806692|NCT00474266|Secondary|Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms|Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.|During the 43-day (Days 0-42) after first vaccination dose|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2806693|NCT00474266|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.|During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2806726|NCT00474188|Secondary|Time to Progression|"Time from the start of study drug therapy to the first documentation of disease progression.~Study terminated prematurely. Analysis not conducted."|One year||||Days||95% Confidence Interval|Median
2806695|NCT00474266|Secondary|Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination|Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.|During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.|||Participants|||Count of Participants
2806696|NCT00474266|Secondary|Anti-varicella Antibody Titers|Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2806697|NCT00474266|Secondary|Anti-varicella Antibody Titers|Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2806698|NCT00474266|Secondary|Anti-rubella Antibody Concentrations|Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2806699|NCT00474266|Secondary|Anti-rubella Antibody Concentrations|Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2806700|NCT00474266|Secondary|Anti-mumps Antibody Concentrations|Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||U/mL||95% Confidence Interval|Geometric Mean
2806701|NCT00474266|Secondary|Anti-mumps Antibody Concentrations|Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||U/mL||95% Confidence Interval|Geometric Mean
2806702|NCT00474266|Secondary|Anti-measles Antibody Concentrations|Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.|42 days after the second Priorix-Tetra vaccine dose (Day 126)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2806703|NCT00474266|Secondary|Anti-measles Antibody Concentrations|Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2806704|NCT00474266|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2806727|NCT00474188|Secondary|Duration of Response|"Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.~Study terminated prematurely. Analysis not conducted."|One year||||Days||95% Confidence Interval|Median
2806705|NCT00474266|Secondary|Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806706|NCT00474266|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values|The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806707|NCT00474266|Secondary|Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values|Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.|Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2806708|NCT00474266|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.|Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2806709|NCT00474266|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.|Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806710|NCT00474266|Primary|Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values|The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806711|NCT00474266|Primary|Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.|The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806712|NCT00474266|Primary|Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values|The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806713|NCT00474266|Primary|Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values|The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2812626|NCT00433654|Secondary|Atrial Pacing Capture Threshold|Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant|Includes all subjects with data.|||Volts||Standard Deviation|Mean
2806714|NCT00474266|Primary|Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values|The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.|42 days after the first vaccine dose (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2806715|NCT00474253|Secondary|Number of Participants Experiencing General Muscle Weakness|The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups.|Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations|||Participants|||Count of Participants
2806716|NCT00474253|Secondary|Number of Participants Able to Perform 5-Second Head Lift|The number of participants who were able to lift their head for 5 seconds was assessed as a measure of recovery following neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved.|Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations|||Participants|||Count of Participants
2806717|NCT00474253|Secondary|Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation|The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.|Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations|||Participants|||Count of Participants
2806718|NCT00474253|Secondary|Level of Consciousness: Number of Participants Arousable With Minimal Stimulation|The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.|Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations|||Participants|||Count of Participants
2806719|NCT00474253|Secondary|Level of Consciousness: Number of Participants Awake and Oriented|The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness. The clinical level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.|Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment, had at least one post-baseline efficacy measurement, and had no major protocol violations|||Participants|||Count of Participants
2806720|NCT00474253|Secondary|Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.|Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment and had at least one post-baseline efficacy assessment|||Minutes||Standard Deviation|Mean
2806721|NCT00474253|Primary|Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.|Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine|All participants who received study treatment and had at least one post-baseline efficacy assessment|||Minutes||Standard Deviation|Mean
2806722|NCT00474240|Secondary|Percent Change From Baseline of Other Lipids||After 8 weeks of study drug|Intent To Treat|||Percent||Standard Deviation|Mean
2806723|NCT00474240|Primary|Percent Change From Baseline in LDL-C at 8 Weeks||Atfer 8 weeks on study drug|Intent To Treat|||Percent Change||Standard Deviation|Mean
2806724|NCT00474201|Primary|Gemfibrozil Area Under the Concentration vs. Time Curve (AUC)|AUC (ng*hr/mL) of gemfibrozil when given as a 600 mg dose by itself compared to gemfibrozil AUC after 14.5 days of lopinavir-ritonavir (400mg/100mg) twice daily.|22 days per subject (approximately 1 year for entire study completion)|Fifteen healthy volunteers were enrolled in this protocol based on an a priori power analysis. All 15 subjects completed the protocol and results reported are those from all 15 participants.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2806725|NCT00474188|Secondary|Progression-free Survival|"Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.~Study terminated prematurely. Analysis not conducted."|One year||||Days||95% Confidence Interval|Median
2806729|NCT00474188|Primary|Tumor Response Rate|"Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).~Study terminated prematurely. Analysis not conducted."|One Year|Study terminated prematurely. Analyses of efficacy not conducted.|||Participants||95% Confidence Interval|Mean
2806730|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication||Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.|||Percentage of participants||95% Confidence Interval|Number
2806731|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied|Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.|Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.|||Milligram (mg)||Standard Deviation|Mean
2806732|NCT00474175|Secondary|Global Satisfaction Assessment|Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale. Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent).|120 minutes|ITT population included all randomized participants who received study medication.|||Units on a scale||Standard Deviation|Mean
2806733|NCT00474175|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores|PRID is sum of PID and DPRS scores at each post-dosing time point. The overall possible score range, for PRID is -1 (worst) to 7 (best). PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|5 to 120 minutes|ITT population included all randomized participants who received study medication.|||Units on a scale||Standard Deviation|Mean
2806734|NCT00474175|Secondary|Time to Dropping Out Due to Lack of Efficacy or Rescue Medication|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
2806735|NCT00474175|Secondary|Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores|SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes. SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120. PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point. PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|60 minutes and 120 minutes|ITT population included all randomized participants who received study medication.|||Units on a scale||Standard Deviation|Mean
2806736|NCT00474175|Secondary|Duration of Effect|Duration of effect was defined as the time difference between onset of effect and its offset. Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained. Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
2806737|NCT00474175|Secondary|Time to Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
2806738|NCT00474175|Secondary|Time to First Confirmed Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.|||Minutes||95% Confidence Interval|Median
2806739|NCT00474175|Primary|Percentage of Participants With a Response|Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).|Baseline, 5, 10, 15 and 20 minutes|Intent to treat (ITT) population included all randomized participants who received study medication.|||Percentage of participants|||Number
2806740|NCT00474123|Secondary|Endothelial Progenitor Cells|Endothelial progenitor cells were evaluated by flow cytometry. Selected cells were positive for CD31, CD34 and VEGFR receptors.|Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.||||percentage||Standard Deviation|Mean
2806741|NCT00474123|Secondary|Triglyceride||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.||||percentage||Standard Deviation|Mean
2806742|NCT00474123|Secondary|LDL Cholesterol||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.||||percentage||Standard Deviation|Mean
2806743|NCT00474123|Primary|Interleukin-6|A commercial ELISA assay detecting IL-6 (Siemens, USA) was applied.|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.||||percentage||Inter-Quartile Range|Median
2806744|NCT00474123|Primary|Soluble CD40 Ligand|A commercial ELISA assay detecting sCD40L (R&D Systems, USA) was applied. Detection limits and intra-assay variability was respectively, as follows: sCD-40L 15.6 pg/mL (intra-assay variability not available).|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.||||percentage||Standard Deviation|Mean
2806745|NCT00474123|Primary|Soluble Intercellular Adhesion Molecule (sICAM)-1|serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK)|Change from baseline at 6 weeks|per protocol|||percentage||Standard Deviation|Mean
2806746|NCT00474123|Primary|Monocyte Chemoattractant Protein (MCP)-1|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK).|Change from baseline at 6 weeks|per protocol|||percentage||Standard Deviation|Mean
2806747|NCT00474123|Primary|Platelet Function Analyzer [PFA]-100|Samples were collected in 3.8% sodium citrate (buffered, pH 5.5, Vacutainer, Becton Dickinson, Plymouth, UK) for platelet function tests. Platelet function assays were processed within 2 hours of blood collection. The PFA-100 records the closure time (CT), witch means the time in seconds (s) from the start of the test until the platelet plug occludes the aperture.|Change from baseline at 6 weeks|per protocol|||Percentage||Standard Deviation|Mean
2806748|NCT00474123|Primary|Oxidized Low-Density Lipoprotein Cholesterol|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting oxLDL (Mercodia, USA) were applied.|Change from baseline at 6 weeks|per protocol|||Percentage||Standard Deviation|Mean
2806749|NCT00474123|Primary|C-reactive Protein|Serum was separated by centrifugation from the blood samples. For high-sensitivity C-Reactive Protein measurement, whole venous blood was collected in tubes without anticoagulant and centrifuged at room temperature. Serum C-Reactive Protein was assessed with a high-sensitivity, latex microparticle-enhanced immunoturbidimetric assay (Behring Nephelometer Analyzer System; Behring Diagnostics, Somerville, NJ).|Change from baseline at 6 weeks|per protocol|||Percentage||Inter-Quartile Range|Median
2806750|NCT00474058|Secondary|Change in Number of Nocturias|Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).|||nocturias||Standard Deviation|Mean
2806751|NCT00474058|Secondary|Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)|Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).|||units on a scale||Standard Deviation|Mean
2806752|NCT00474058|Primary|Change in Parkinson's Disease Sleep Scale (PDSS)|The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2806753|NCT00474058|Primary|Change in Early Morning UPDRS Part III Score|The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2806754|NCT00474045|Secondary|Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||ratio||Full Range|Median
2806755|NCT00474045|Secondary|Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||ratio||Full Range|Median
2806756|NCT00474045|Secondary|Safety - Composite Pregnancy Outcome|Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment.|End of Pregnancy|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and pregnant during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became pregnant again).|||participants|||Number
2806757|NCT00474045|Secondary|Safety - Total Daily Insulin Dose During Pregnancy||Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||U/kg||Standard Deviation|Mean
2806758|NCT00474045|Secondary|Pregnancy Outcome at Follow-Up|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.|||participants|||Number
2812675|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||beats per minute||Standard Deviation|Mean
2806759|NCT00474045|Secondary|Pregnancy Outcome at Delivery|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery.|Delivery Visit|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.|||participants|||Number
2806760|NCT00474045|Secondary|Maternal Safety - Mode of Delivery|Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery.|At Delivery Visit|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. This set in total contains 152 subjects in IDet and 158 subjects in NPH arm. The partcipant analysed for this outcome measure are the number of subjects at delivery visit.|||percentage (%) of subjects|||Number
2806761|NCT00474045|Secondary|Maternal Safety - Acceleration of Nephropathy|Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of nephropathy was summarised by treatment and missing data was imputed using LOCF.|||participants|||Number
2806762|NCT00474045|Secondary|Maternal Safety - Acceleration of Retinopathy in Any Eye|Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of retinopathy was summarised by treatment and missing data was imputed using LOCF.|||participants|||Number
2806763|NCT00474045|Secondary|Maternal Safety - Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||participants|||Number
2806764|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up|Change in the pulse was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||beats/minute||Standard Deviation|Mean
2806765|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the diastolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||mmHg||Standard Deviation|Mean
2806766|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the systolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||mmHg||Standard Deviation|Mean
2806767|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit|Change in the body weight was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.|||kg||Standard Deviation|Mean
2806768|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood||At Delivery|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. IDet in cord blood was analysed for subjects in the IDet Arm and only for 98 subjects, as for 72 subjects it was reported as below measuring range (<25.00 pmol/L).|||pmol/L||Full Range|Median
2806769|NCT00474045|Secondary|Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||ratio||Full Range|Median
2806770|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
2806771|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T)|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
2806772|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
2806773|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies|Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
2806774|NCT00474045|Secondary|Maternal Safety - Change in Insulin Aspart Specific Antibodies|Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
2806775|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir Specific Antibodies|Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||%B/T||Full Range|Median
2806776|NCT00474045|Secondary|Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mg/dL||Standard Deviation|Mean
2806777|NCT00474045|Secondary|Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mg/mmol||Standard Deviation|Mean
2806778|NCT00474045|Secondary|Maternal Safety - Change in Urine Albumin Level (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||g/dL||Standard Deviation|Mean
2806779|NCT00474045|Secondary|Maternal Safety - Change in Thrombocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||10^9 cells/L||Standard Deviation|Mean
2806780|NCT00474045|Secondary|Maternal Safety - Change in Leukocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||10^9 cells/L||Standard Deviation|Mean
2806781|NCT00474045|Secondary|Maternal Safety - Change in Haemoglobin Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2806782|NCT00474045|Secondary|Maternal Safety - Change in Total Protein Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.Missing data was imputed using LOCF.|||g/dL||Standard Deviation|Mean
2806783|NCT00474045|Secondary|Maternal Safety - Change in Sodium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2806784|NCT00474045|Secondary|Maternal Safety - Change in Potassium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2806785|NCT00474045|Secondary|Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||U/L||Standard Deviation|Mean
2806786|NCT00474045|Secondary|Maternal Safety - Change in Creatinine Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||mcmol/L||Standard Deviation|Mean
2806787|NCT00474045|Secondary|Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||U/L||Standard Deviation|Mean
2806788|NCT00474045|Secondary|Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||U/L||Standard Deviation|Mean
2806789|NCT00474045|Secondary|Maternal Safety - Change in Albumin Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.|||g/dL||Standard Deviation|Mean
2806790|NCT00474045|Secondary|Maternal Safety - Nocturnal Hypoglycaemic Episodes|A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||episodes|||Number
2806791|NCT00474045|Secondary|Maternal Safety - Hypoglycaemic Episodes|All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||episodes|||Number
2806792|NCT00474045|Secondary|Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol.|Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Each pregnant woman analyzed had exactly one Foetus/Newborn that was analyzed for AEs.|||Foetus/Newborns (1 per pregnant woman)|||Number
2806793|NCT00474045|Secondary|Maternal Safety - Number of Subjects With Adverse Events (AEs)|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.|||participants|||Number
2806794|NCT00474045|Secondary|8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P4 (GW 36)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.|||mmol/L||Standard Deviation|Mean
2806795|NCT00474045|Secondary|8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P3 (GW 24)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.|||mmol/L||Standard Deviation|Mean
2806796|NCT00474045|Secondary|Fasting Plasma Glucose (FPG)||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.|||mmol/L||Standard Deviation|Mean
2806797|NCT00474045|Secondary|Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36||At both Visit P3 (GW 24) and Visit P4 (GW 36)|FAS for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using LOCF which was made using pregnancy visits, early termination visit and withdrawal visit. Analysed subjects-subjects with valid HbA1c values at visit P3 and P4.|||participants|||Number
2806798|NCT00474045|Secondary|Glycosylated Haemoglobin (HbA1c) During Pregnancy||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2806799|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Per Protocol Analysis Set (pregnant subjects): comprised all subjects from the FAS (pregnant subjects) except subjects who significantly violated the inclusion/exclusion criteria. Gestational age at delivery must be at least 32 completed weeks.|||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
2806800|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.|||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
2806801|NCT00473889|Secondary|Number of Participants Who Had a Disease Response to Treatment|Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions).|Every 42 days from start of treatment until disease response|"Full analysis set~(FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population."|||Participants|||Number
2806802|NCT00473889|Secondary|Progression Free Survival|Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions.|Start of treatment to disease progression or death|"Full analysis set~(FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population."|||Months||Full Range|Median
2806803|NCT00473889|Primary|Overall Survival|Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.|Start of treatment to death|Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized.|||Months||Full Range|Median
2806804|NCT00473876|Secondary|Possible Mechanisms That Can Explain the Improvement of Exercise Capacity|VE/VCO2 Slope, measurement of the abnormal ventilatory response to exercise identified by an increased slope of ventilation (L/min) vs. CO2 production (VE/VCO2) (L/min) to incremental workload|4 months|39 patients were randomized with 3 dropped out. Therefore, 36 were included in the analysis. There was 1 patient who dropped out in the placebo arm and hence 22 patients were analysed.|||Unitless||Standard Deviation|Mean
2806805|NCT00473876|Primary|Peak VO2|Peak VO2 after 4 months of intervention with either metformin or placebo. The Mean difference between baseline and after 4 months was analyzed using t-test comparing metformin and placebo.|4 months|.In the metformin group,3 patients were lost to follow up therefore excluded from analysis.5 patients were discontinued on medications due to side effects, however,were included in our intention to treat analysis.In the placebo group,1 patient was lost to follow up and was excluded from analysis|||ml/kg/min||Standard Deviation|Mean
2806806|NCT00473837|Secondary|Curve of Hb Change Between Day 3 and Day 30 in the Two Placebo Arms; Changes in Markers of Iron Status, Measures of Inflammation, and Hb Response Between Day 3 and Day 30, and Between Day 3 and Day 90||90 days|||||||
2806807|NCT00473837|Primary|Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms||90 days||||g/L||Standard Deviation|Mean
2806808|NCT00473824|Primary|Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)).|Proportion of subjects who achieve reduction in viral load from the baseline pre-transplant value. Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.|Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.|As the study was terminated early and since no participant in either arm achieved reduction in viral load, it was recorded that zero particpants and zero percent in each arm achieved reduction in viral load.|||percentage of participants|||Number
2806809|NCT00473746|Secondary|Phase 2: Duration of Objective Response|Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic duration of objective response.|||days||95% Confidence Interval|Median
2806811|NCT00473746|Secondary|Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||participants|||Number
2806812|NCT00473746|Secondary|Phase 2: Duration of PSA Response|Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2806813|NCT00473746|Secondary|Phase 2: Time to PSA Progression|The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2806814|NCT00473746|Secondary|Phase 2: Radiographic Objective Response Rate (RAD-ORR)|The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic objective response rate.|||participants|||Number
2806815|NCT00473746|Secondary|Phase 2: PSA Progression Free Survival (PSA-PFS)|PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.|||days||95% Confidence Interval|Median
2806816|NCT00473746|Secondary|Phase 2: Radiographic Progression Free Survival (RAD-PFS)|RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study. RAD-PFS was not analyzed because of insufficient data to provide a meaningful estimate of the median and associated confidence interval (CI)|||days||Full Range|Median
2806817|NCT00473746|Secondary|Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||Liter (L)||Standard Deviation|Mean
2806818|NCT00473746|Secondary|Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||liter per hour (l/hr)||Standard Deviation|Mean
2806819|NCT00473746|Secondary|Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hour (hr)||Standard Deviation|Mean
2806820|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hr*nmol/L||Standard Deviation|Mean
2806821|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hr*nmol/L||Standard Deviation|Mean
2806847|NCT00473668|Secondary|Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens|Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available|||Subjects|||Number
2806822|NCT00473746|Secondary|Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose)|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.|||hour (hr)||Standard Deviation|Mean
2806823|NCT00473746|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.|ITT population included all participants who were enrolled into the study.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2806824|NCT00473746|Primary|Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)|Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement.|Up to 12 weeks from start of treatment|Intent-to-treat (ITT) population included all participants who were enrolled into the study.|||participants|||Number
2806825|NCT00473746|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate|The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.|Up to Cycle 12|Safety population included all enrolled participants who received any study drug. MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day (mg/day [recommended maximum dose for phase 1]) and 1000 mg/day was taken as test dose in phase 2.|||mg/day|||Number
2806826|NCT00473694|Secondary|Number of Participants Experiencing General Muscle Weakness|The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. Participants who were not cooperative with the examination were not included in the assessment.|Up to 24 hours|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Participants|||Count of Participants
2806827|NCT00473694|Secondary|Number of Participants Able to Perform a 5-second Head Lift|The number of participants who were able to lift their head for 5 seconds was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. Participants who were not cooperative with the examination were not included in the assessment.|Up to 24 hours|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Participants|||Count of Participants
2806828|NCT00473694|Secondary|Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)|The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.|Up to 24 hours|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Participants|||Count of Participants
2806829|NCT00473694|Secondary|Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)|The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.|Up to 24 hours|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Participants|||Count of Participants
2806845|NCT00473668|Secondary|Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen|Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
2806830|NCT00473694|Secondary|Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)|The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment.|Up to 24 hours|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Participants|||Count of Participants
2806831|NCT00473694|Secondary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium|Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.|Up to approximately 5 hours after administration of study drug|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Minutes||Standard Deviation|Mean
2806832|NCT00473694|Secondary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium|Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.|Up to approximately 3 hours after administration of study drug|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Minutes||Standard Deviation|Mean
2806833|NCT00473694|Secondary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium|Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.|Up to approximately 4 hours after administration of study drug|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Minutes||Standard Deviation|Mean
2806834|NCT00473694|Secondary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium|Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.|Up to approximately 2 hours after administration of study drug|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Minutes||Standard Deviation|Mean
2806846|NCT00473668|Secondary|Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen|A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
2806879|NCT00473512|Other Pre-specified|Number of Participants With Change From Baseline in Biochemical Bone Markers||Baseline, Cycle 2, 4, 8, 12|Data was reported in individual participant listings but not summarized due to statistical constraints.||||||
2806835|NCT00473694|Primary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium|Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.|Up to approximately 6 hours after administration of study drug|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Minutes||Standard Deviation|Mean
2806836|NCT00473694|Primary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium|Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times.|Up to approximately 3 hours after administration of study drug|The analysis population was the Intent-to-Treat population that included all participants who received study drug and had at least one post-baseline efficacy assessment and were analyzed in the group to which they were randomized (initial treatment assignment and not by the actual treatment received).|||Minutes||Standard Deviation|Mean
2806837|NCT00473668|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0-Month 3)|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
2806838|NCT00473668|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
2806839|NCT00473668|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
2806840|NCT00473668|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period post-vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
2806841|NCT00473668|Secondary|Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2806842|NCT00473668|Secondary|Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2806843|NCT00473668|Secondary|Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2806844|NCT00473668|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2807265|NCT00468858|Primary|Safety: Incidence of All and Grade 3 Solicited Local Symptoms|Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)|Within 21 days (days 0-20) f/up period after each vaccine dose||||number of occurances|||Number
2806848|NCT00473668|Secondary|Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off|Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells.|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
2806849|NCT00473668|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
2806850|NCT00473668|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Subjects|||Number
2806851|NCT00473668|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens|A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).|At Month 3|The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available.|||Participants|||Count of Participants
2806852|NCT00473655|Secondary|ApoB Levels|Change in the levels from baseline to end of study|8 weeks||||mg/dl||Standard Deviation|Mean
2806853|NCT00473655|Secondary|Adverse Events Reported|Number of participants with AEs and SAEs reported|8 weeks||||Participants|||Number
2806854|NCT00473655|Secondary|hsCRP Reduction|Reduction from baseline to end of study|8 weeks||||mg/L||Standard Deviation|Mean
2806855|NCT00473655|Secondary|ApoA1 Levels|Change in the levels from baseline to end of study|8 weeks||||mg/dl||Standard Deviation|Mean
2806856|NCT00473655|Secondary|HDL-C Increase|Increase from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
2806857|NCT00473655|Secondary|Total Cholesterol Reduction|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
2806858|NCT00473655|Secondary|LDL-C Reduction|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
2806859|NCT00473655|Secondary|Non-HDL-C Reduction|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
2806860|NCT00473655|Primary|Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)|Reduction from baseline to end of study|8 weeks||||mg/dL||Standard Deviation|Mean
2806861|NCT00473642|Primary|Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol|Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study, the number of letters gained over the course of the study. In other words the baseline visual acuity in letters was subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.|12 months||||letters||Standard Deviation|Mean
2806862|NCT00473642|Secondary|Time to First Retreatment After Loading Doses, Average Number of Retreatments Over 12 Months, Central Macular Thickness on OCT, the Number of Recurrent CNV, the Number of Patients With Persistent CNV After the Mandatory Loading Doses.||12 months|||||||
2806863|NCT00473642|Primary|Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months||12 months|||||||
2806864|NCT00473590|Secondary|Number of Participants With Selected Adverse Events (AEs)|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).|Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.|||Participants|||Number
2806865|NCT00473590|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.|From randomization to disease progression or death on study (up to 116 weeks).|Randomized Patients|||months||95% Confidence Interval|Median
2806866|NCT00473590|Secondary|Overall Survival (OS)|Overall survival was defined as the duration of time from randomization until death from any cause. All deaths were included, whether they occurred on study treatment or following treatment discontinuation. Overall survival was estimated using Kaplan-Meier. For patients who had not died, overall survival was censored at the date that the patient was last known to be alive.|From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients|||Months||95% Confidence Interval|Median
2806892|NCT00473434|Secondary|The Percentage of Participants Presenting Clinical Deterioration Throughout the Study|This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.|52 Weeks|All participants with evaluable data at each measurement time point|||percentage of participants|||Number
2819476|NCT00386776|Secondary|Number of Office Visits by Patients|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
2806867|NCT00473590|Secondary|Duration of Response|Duration of response was defined as the time from the initial response to disease progression or death on study. Disease progression was determined by the investigator using the IMWG's uniform response criteria and defined as an increase of ≥25% from best response in: Serum M-protein and/or Urine M-protein and/or Marrow plasma cells; or new or increased plasmacytomas or bone lesions; or hypercalcemia due to myeloma. Duration of response was estimated using Kaplan-Meier. For patients who had not progressed or died, duration of response was censored at the date of the last response assessment.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients with an overall response|||Months||95% Confidence Interval|Median
2806868|NCT00473590|Secondary|Percentage of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the IMWG's uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients|||Percentage of Participants||95% Confidence Interval|Number
2806869|NCT00473590|Secondary|Number of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR, respectively) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the International Myeloma Working Group's (IMWG's) uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients|||participants|||Number
2806870|NCT00473564|Secondary|Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.|Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins|3 - 24 months postoperatively|Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System|||participants|||Number
2806871|NCT00473564|Primary|Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions|Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions|Intraoperatively average of 2 hours||||participants|||Number
2806872|NCT00473512|Other Pre-specified|Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone|The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.||||||
2806873|NCT00473512|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Abiraterone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hour||Standard Deviation|Mean
2806874|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours*nmol/L||Standard Deviation|Mean
2806875|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone|Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours*nmol/L||Standard Deviation|Mean
2806876|NCT00473512|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours||Standard Deviation|Mean
2806877|NCT00473512|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The Cmax is defined as maximum observed analyte concentration.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||nmol/L||Standard Deviation|Mean
2806878|NCT00473512|Other Pre-specified|Mean Plasma Concentration of Abiraterone||Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.||||||
2806880|NCT00473512|Other Pre-specified|Time to Prostate Cancer Pain Progression|The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.|Baseline up to 12 cycles|Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.||||||
2806881|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone Precursors|Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.|||ng/dL||Full Range|Median
2806882|NCT00473512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose of study medication|Included all participants who received any amount of the study medication.|||participants|||Number
2806883|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone|Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.|||ng/dL||Full Range|Median
2806884|NCT00473512|Secondary|Overall Survival|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline up to end of study (1160 days)|Data was not analyzed due to high number of participants censored for survival.||||||
2806885|NCT00473512|Secondary|Time to Disease Progression|Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.|Baseline up to end of study (1160 days)|Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.||||||
2806886|NCT00473512|Secondary|Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.||||||
2806887|NCT00473512|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Days||Full Range|Median
2806888|NCT00473512|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2806889|NCT00473512|Primary|Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.|Baseline, Week 12|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2806890|NCT00473434|Secondary|The Length of Hospitalizations Throughout the Study||52 weeks|Participants who were hospitalized and had evaluable data at each measurement time point|||days||Standard Deviation|Mean
2806891|NCT00473434|Secondary|The Number of Hospitalizations Throughout the Study|This outcome measure is intended to document all hospitalizations that occurred throughout the study.|52 Weeks|All participants with evaluable data at each measurement time point|||events|||Number
2806893|NCT00473434|Secondary|The Global Assessment of Functioning (GAF) Throughout the Study|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|52 Weeks|All participants with evaluable data at each measurement time point|||scores on a scale||Standard Deviation|Mean
2806894|NCT00473434|Secondary|The Clinical Global Impression of Severity (CGI-S) Throughout the Study|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|52 weeks|All participants with evaluable data at each measurement time point|||scores on a scale||Standard Deviation|Mean
2806895|NCT00473434|Primary|The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population|||mg||95% Confidence Interval|Median
2806896|NCT00473434|Primary|The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population|||mg||Standard Deviation|Mean
2806897|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57|||mg||95% Confidence Interval|Median
2806898|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57|||mg||Standard Deviation|Mean
2806899|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population|||mg||95% Confidence Interval|Median
2806900|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population|||mg||Standard Deviation|Mean
2806901|NCT00473382|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
2806902|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806903|NCT00473382|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
2806904|NCT00473382|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806905|NCT00473382|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Treatments||Standard Deviation|Mean
2806906|NCT00473382|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2806916|NCT00473330|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
2806907|NCT00473382|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2806908|NCT00473382|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
2806909|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Letters||Standard Deviation|Mean
2806910|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806911|NCT00473382|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806912|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
2806913|NCT00473382|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.|||Percentage of patients||95% Confidence Interval|Number
2806914|NCT00473330|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
2806915|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of participants||95% Confidence Interval|Number
2812676|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride||Baseline and 13 Week Endpoint|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||millimole per Liter||Standard Deviation|Mean
2806917|NCT00473330|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806918|NCT00473330|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Treatments||Standard Deviation|Mean
2806919|NCT00473330|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2806920|NCT00473330|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
2806921|NCT00473330|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||µm||Standard Deviation|Mean
2806922|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.|||Letters||Standard Deviation|Mean
2806923|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806924|NCT00473330|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Percentage of patients||95% Confidence Interval|Number
2806925|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.|||Letters||Standard Deviation|Mean
2807180|NCT00470535|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion|Every cycle for up to 52 weeks|All treated and eligible patients|||months||95% Confidence Interval|Median
2806926|NCT00473330|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.|||Percentage of patients||95% Confidence Interval|Number
2806927|NCT00473265|Secondary|Mineralizing Surface|Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus one year|Only 14 subjects had paird bone biopsies obtained at baseline and after 12 months of PTH(1-84) treatment.|||percentage of surface||Standard Deviation|Mean
2806928|NCT00473265|Secondary|Cortical Porosity|Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.|||percentage of porosity||Standard Deviation|Mean
2806929|NCT00473265|Secondary|Trabecular Number|trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.|||mm^-1||Standard Deviation|Mean
2806930|NCT00473265|Secondary|Trabecular Width|Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.|||micrometers||Standard Deviation|Mean
2806931|NCT00473265|Secondary|Percent Change in BMD From Baseline to 24 Months by DXA|Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).|baseline versus 24 months|Only the first 30 participants who completed 24 months of the study were analyzed|||percentage of change to BMD||Standard Deviation|Mean
2806932|NCT00473265|Primary|Requirements for Calcium Supplementation|Serum and urinary calcium levels maintained by change in requirements for calcium supplementation|2 years|Only the first 30 participants to complete 24 months in the study were analyzed|||grams per day of calcium supplementation||Standard Deviation|Mean
2806933|NCT00473083|Primary|Overall Incidence of Grade 3 Rash|"The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group."|From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year||||percentage of participants|||Number
2806934|NCT00473083|Secondary|Time to First Presentation of Rash||Up to onset of rash while on study treatment|Subjects with maximum severity of rash of grade 1, 2a, 2b and 3|||days||Standard Deviation|Mean
2806935|NCT00473083|Secondary|Duration of Treatment||Up to one year||||months||95% Confidence Interval|Median
2806936|NCT00473083|Secondary|Overall Survival||Until death||||months||95% Confidence Interval|Median
2806937|NCT00473083|Secondary|Severity of Rash Caused by Erlotinib|The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash.|Onset until resolution, up to 4 weeks following progression, on average of 1 year|Arm 1 (n=42), Arm 2 (n=42), Arm 3, (n=41)|||percentage of participants|||Number
2806938|NCT00473083|Primary|Time Duration From Onset of Rash Until Resolution|"To investigate if the rash caused by erlotinib is self-limiting.~A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.~The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.~The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2."|From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year|"Patients With Maximum Severity of Rash Grade 1, 2b: Arm 1 (n=36), Arm 2 (n=38), Arm 3 (n=27)~Patients With Maximum Severity of Rash Grade 3: Arm 1 (n=6), Arm 2 (n=4), Arm 3 (n=14)"|||days||Inter-Quartile Range|Median
2806939|NCT00473083|Primary|Overall Incidence of Rash|"The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group."|From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year||||percentage of participants|||Number
2806940|NCT00472849|Primary|Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days)|Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants received a subsequent cycle of treatment with 1 additional day of fludarabine and cytarabine treatment no less than 4 weeks from the initiation of the previous cycle if no drug-related grade 3 or 4 non-hematologic life-threatening adverse events, and drug-related non-hematologic toxicity resolved to baseline or < grade 2. A maximum of 6 cycles were administered.|Up to 36 weeks (6 cycles each 4-6 weeks)||||mg/m^2|||Number
2806941|NCT00472849|Secondary|Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission|Overall Response includes Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) in high-risk, previously untreated participants with Chronic Lymphocytic Leukemia treated with CFAR using National Cancer Institute - Working Group response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Up to 36 weeks (6 cycles each 4-6 weeks)||||participants|||Number
2806942|NCT00472797|Other Pre-specified|SF-36 Physical and Mental Component Scores|Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.|Change from Baseline to Each Visit|ITT|||Score||Standard Deviation|Mean
2806943|NCT00472797|Secondary|Tolerability - Redness at Injection Site|Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.|Baseline to Week 12 (LOCF)|ITT and LOCF|||mm||Standard Deviation|Mean
2806944|NCT00472797|Secondary|Tolerability in Pain Using Visual Analog Scale (VAS)|The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.|Baseline to Week 12|ITT|||Participants|||Number
2806945|NCT00472797|Secondary|Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12|The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).|Baseline to Week 12|ITT and LOCF|||score on scale||Standard Deviation|Mean
2806946|NCT00472797|Secondary|Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 - score at baseline.|Baseline to Week 12||||score on scale||Standard Deviation|Mean
2806947|NCT00472797|Secondary|Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).|Baseline and Week 12|Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response|||score on scale||Standard Deviation|Mean
2806948|NCT00472797|Primary|Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 - score at baseline) / score at baseline.|% change from Baseline to Week 12|Safety: This population includes all subjects who received at least one dose of study drug. To explain difference in number, 1 subject lost to follow-up, 1 subject withdrew consent|||percent change||Standard Deviation|Mean
2806949|NCT00472732|Primary|Fractional Anisotropy|Measure of white matter integrity in OTCD Patients and Controls in frontal white matter. Fractional anisotropy values fall on a scale of 0 to 1, with 0 meaning that the diffusion of water is isotropic and unrestricted, or equally restricted, in all directions and with 1 meaning that diffusion occurs along only one axis and is fully restricted along all other directions. Scores closer to 1 are associated with intact white matter while scores closer to 0 are associated with white matter damage.|one time measurement at study baseline|Five OTCD Patients and four healthy controls were excluded due to excessive head motion.|||units on a scale||Standard Deviation|Mean
2806950|NCT00472732|Primary|Functional MRI Activation in N-Back Tast|"Measure of blood oxygen level dependent (BOLD) signal of OTCD patients and healthy controls during an N-Back task comparing 2-back and 1-back conditions. This contrast was created for each participant using SPM and then entered into a group analysis in which we compare percent signal change between groups. Therefore, we never see BOLD signal change at the individual level, which is why we never see scores or numbers at the individual level and we cannot calculate a measure of dispersion for this data."|one time measurement at study baseline|Five OTCD patients and one healthy control were excluded due to excessive head motion.|||percent signal change|||Number
2806951|NCT00472732|Primary|Concentration of Glutamine and Myoinositol by MRS|"Concentration based on area under curve on 1H MRS and quantitated by LCModel. A metabolite's tissue concentration is related to the integrated amplitude of the MRS signal it produces. Integrated amplitude is the area under the MRS signal curve. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. This means, 257 free induction decays. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don't have the measurement at each time point.~Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|one time measurement at study baseline||||mM||Standard Deviation|Mean
2806952|NCT00472641|Secondary|Changes From Baseline to Endpoint in Body Mass Index (BMI)|Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI).|Baseline, 12 weeks||||kg/m^2||Standard Deviation|Mean
2806953|NCT00472641|Primary|The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.|The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.|Baseline, 12 weeks||||Pounds||Standard Deviation|Mean
2806954|NCT00472576|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.|Measured daily for 12 days, where the endpoint is the primary outcome|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.|||Score on a scale||Standard Error|Least Squares Mean
2806955|NCT00472576|Secondary|Hamilton Depression Rating Scale (HDRS)|The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.|Measured daily for 12 days, where the endpoint is primary|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.|||Score on a scale||Standard Error|Least Squares Mean
2806956|NCT00472446|Secondary|Hospital Stay|time from surgery to Hospital release in days|90 days||||days||Standard Deviation|Mean
2806957|NCT00472446|Secondary|Mean Consumption of Post-operative Analgetics|mean pooled dose of post-operative analgetics|5 days after surgery||||gram||Standard Deviation|Mean
2806958|NCT00472446|Secondary|Consumption of Post-operative Analgetics|number of participants taking post-operative analgetics|5 days after surgery||||participants|||Number
2806959|NCT00472446|Secondary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|24 hours after surgery||||units on a scale||Standard Deviation|Mean
2806960|NCT00472446|Primary|Pooled Relative Treatment Effect of VAS|"Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain)~The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)"|4 days after surgery||||pooled relative treatment effect||95% Confidence Interval|Number
2806961|NCT00472446|Primary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|6 hours after surgery||||units on a scale||Standard Deviation|Mean
2806962|NCT00472420|Secondary|Event Free Survival (EFS)|EFS was defined as the median time, in months, from the date of study entry disease progression, relapse, secondary malignancy, death or last contact. Relapse was defined by: a) appearance of any new lesion or a ≥ 50% increase in size of previously involved sites, or b) ≥ 50% increase in GTD of any previously identified LN >1 cm in short axis or in the SPD of more than one LN. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population|||months||95% Confidence Interval|Median
2806963|NCT00472420|Secondary|Progression Free Survival (PFS)|PFS was defined as the median time, in months, from the date of study entry to disease progression, death due to mantle cell lymphoma, or last contact. Progressive disease (PD) was defined by: a) 50% increase from nadir in the SPD of any previously identified abnormal LN, or b) appearance of any new lesion during or at the end of treatment. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population|||months||95% Confidence Interval|Median
2806964|NCT00472420|Primary|Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)|CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) > 75% decrease in SPD of LNs > 1.5 cm, and > 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.|Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population|||participants|||Number
2806965|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the maintenance phase. A negative mean change indicates an improvement."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Safety Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.|||units on a scale||Standard Deviation|Mean
2806982|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Observed, i.e. participants contributing data via their electronic diary.|||units on a scale||Standard Deviation|Mean
2806966|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the titration phase."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Per Protocol Set (Titration Phase), observed. Start of Titration and Endpoint Titration observations.|||units on a scale||Standard Deviation|Mean
2806967|NCT00472303|Secondary|Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.~The following withdrawal categories are based on the total COWS score:~None: total score below 5;~Mild: total score from 5 to 12;~Moderate: total score 13 to 24;~Moderately Severe: total score 25 to 36;~Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 43 (End of Maintenance Phase)|Safety Analysis Set. Participants that did not discontinue due to adverse event during the first week of the maintenance phase and started opioid after last study medication.|||participants|||Number
2806968|NCT00472303|Secondary|Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.~The following withdrawal categories are based on the total COWS score:~None: total score below 5;~Mild: total score from 5 to 12;~Moderate: total score 13 to 24;~Moderately Severe: total score 25 to 36;~Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 14 (End of Titration Phase)|Safety Analysis Set (Titration Phase). Participants that took at least one dose of trial medication in the titration phase, and discontinued trial medication at the end or during the titration phase and did not continue on other opioid medication.|||participants|||Number
2806969|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of maintenance to the completion of treatment is reported. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|"FAS (Maintenance Phase) Last Observation Carried Forward for participants re-randomized.~Tapentadol: 105 participants responded at the start and 103 participants at the end.~Morphine: 108 participants responded at the start and 107 participants at the end.~Placebo: 110 participants responded at the start and 107 participants at the end."|||participants|||Number
2806970|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) in the Titration Phase.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of the titration phase to the end of the titration phase was measured. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 1 (Start of Titration); Day 14 (end of Titration Phase)|"Full Analysis Set (Titration Phase), observed. Tapentadol: 302 participants dosed gave a response at the start of titration and from 309 participants at the end of titration.~Morphine: 143 participants dosed gave a response at the start of titration and from 142 participants at the end of titration."|||participants|||Number
2806971|NCT00472303|Secondary|Patient Global Impression of Change|"In the Patient Global Impression of Change (PGIC) the participant is asked Since I began study treatment, my overall status is. The participant is asked to circle one of seven categories. Scores range from very much improved to very much worse. The question was asked at the end of the maintenance phase with reference to the start of the maintenance phase where the participant continued at the dose that was effective at the end of the Titration Phase."|Day 43 (End of Maintenance Phase)|Full Analysis Set, observed.|||participants|||Number
2806972|NCT00472303|Secondary|Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from Day 15, a negative mean value indicates a worsening of health-related quality of life since the start of the maintenance phase.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.|||units on a scale||Standard Deviation|Mean
2806983|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Phase), observed.|||units on a scale||Standard Deviation|Mean
2806973|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).~The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A negative change in the mean indicates a worsening in health status since the beginning of the maintenance phase. A positive change indicates an improvement in health. The minimal important difference in the Health Status Index is 0.074 (range -0.011 to 0.140)."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations. No morphine treatment analysis was planned.|||units on a scale||Standard Deviation|Mean
2806974|NCT00472303|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate better health. The values indicated represent the change from Day 1, a positive value indicates an improvement since the start of treatment.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.|||units on a scale||Standard Deviation|Mean
2806975|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).~The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A positive change in the mean indicates that during this phase the health status improved. A positive change indicates an improvement in health. The minimal important difference is 0.074 (range -0.011 to 0.140)."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.|||units on a scale||Standard Deviation|Mean
2806976|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full analysis set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.|||units on a scale||Standard Deviation|Mean
2806977|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Period), observed. Start of Titration and Endpoint Titration observations.|||units on a scale||Standard Deviation|Mean
2806978|NCT00472303|Secondary|The Average Mean Total Daily Dose of Rescue Medication.|Mean total daily dose of rescue medication morphine sulphate immediate release tablets in milligrams per day (mg/day).|Day 1 (Start of Titration Phase) through Day 43 (End of Maintenance Phase)|Full analysis set for each phase of the trial, observed.|||milligrams per day of morphine rescue||Standard Deviation|Mean
2806979|NCT00472303|Secondary|Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase|Participants were issued morphine 10 mg immediate release medication. The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the maintenance phase were counted. This use of morphine immediate release was captured in each participant's electronic diary.|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance phase), observed.|||participants|||Number
2806980|NCT00472303|Secondary|Use of Rescue Medication in the Titration Phase.|"The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the titration phase were counted. This data was captured in an electronic diary.~During the trial, morphine immediate release 10 mg was allowed as required without a maximum dose defined. However, participants were only re-randomized if their mean consumption of rescue medication was less or equal to 2 doses (20 mg) per day during the last 3 days of the titration phase)."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration phase), observed.|||participants|||Number
2806981|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the 3 days prior to re-randomization or during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2806998|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
2806984|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2806985|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.|||units on a scale||Standard Deviation|Mean
2806986|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.|||units on a scale||Standard Deviation|Mean
2806987|NCT00472303|Primary|Number of Participants Scored as Responder in Maintenance Phase.|"A responder is a participant in the study that:~completed 28 days of the maintenance phase~had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.~did not use more than 20 mg of rescue medication per day on average in the 28 day maintenance period (from Day 18 to Day 43).~A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that failed to meet only 1 of the 3 criteria is not counted as a responder."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase).|||participants|||Number
2806988|NCT00472290|Primary|Incidence of Antibody (AB) Formation||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.|Safety analysis includes subjects who took at least one dose of romiplostim.|||Participant|||Number
2806989|NCT00472290|Secondary|Duration of Platelet Response|Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Weeks|Weeks with Platelet Response|Full Range|Median
2806990|NCT00472290|Secondary|Time to First Platelet Response|Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Weeks|Weeks with Platelet Response|95% Confidence Interval|Median
2806991|NCT00472290|Secondary|Weeks With Platelet Response Per Year|During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Weeks/Subject-year|Weeks with Platelet Response|95% Confidence Interval|Mean
2806992|NCT00472290|Secondary|Platelet Transfusion Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Events/100 subject-year|Events|95% Confidence Interval|Mean
2806993|NCT00472290|Secondary|Weekly Bleeding Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.|||Events/100 subject-year|Events|95% Confidence Interval|Mean
2806994|NCT00472290|Primary|Overall Summary of Adverse Events||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .|Safety analysis includes subjects who took at least one dose of romiplostim.|||Participant|||Number
2806995|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||bpm||Standard Deviation|Mean
2806996|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||bpm||Standard Deviation|Mean
2806997|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication|||mm Hg||Standard Deviation|Mean
2807001|NCT00472199|Secondary|Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation|"Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation).~Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline."|after at least 1 week of treatment discontinuation|Treated Set, all patients who were documented to have taken at least one dose of study medication|||participants|||Number
2807002|NCT00472199|Secondary|Diagnosis of Classified Augmentation According to Independent Expert Panel|Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.|after at least 4 weeks of treatment|Treated Set and where patients received study medication for at least 4 weeks (Treated Set includes all patients who were documented to have taken at least one dose of of treatment)|||participants|||Number
2807003|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807004|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807005|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Vitality After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better vitality|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807006|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better social functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807007|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807008|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807009|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better physical functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807010|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better mental health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807011|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension General Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health status|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807012|NCT00472199|Secondary|Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less bodily pain|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807013|NCT00472199|Secondary|Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks|RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807014|NCT00472199|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks|The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2812677|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||Units/Liter||Standard Deviation|Mean
2807015|NCT00472199|Secondary|Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks|Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||scores on a scale||Inter-Quartile Range|Median
2807016|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks"|"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807017|NCT00472199|Secondary|"Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks"|"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807018|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks"|"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807019|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks"|"The question was rated on an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week"|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807020|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807021|NCT00472199|Secondary|"Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from none/not at all (0) to very severe (10), to reflect the patient's condition during the previous week"|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Inter-Quartile Range|Median
2807022|NCT00472199|Secondary|Patient Global Impression (PGI) Responder Rate|PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||participants|||Number
2807023|NCT00472199|Secondary|International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate|IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||participants|||Number
2807024|NCT00472199|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder Rate|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values.|||participants|||Number
2807025|NCT00472199|Primary|Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks|IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values|||Scores on a scale||Standard Error|Least Squares Mean
2807026|NCT00472082|Secondary|Safety, Including Incidence of Post- Transplant Infections, Malignancies, Morbidities, Hypertension, Glucose Intolerance, Serum Cholesterol and Triglycerides Profile Over Time, Development of New Anti-donor Antibodies.||1 year|||||||
2807027|NCT00472082|Primary|Efficacy Will be Determined by Change in Renal Function as Measured by Cold Iothalamate Glomerular Filtration Rate(GFR)3 Months After Enrollment, and Acute Rejection Episodes Within the First 6 Months Post Enrollment.||6 months from conversion|||||||
2807028|NCT00472056|Primary|Disease-free Survival (DFS)|DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.|Up to 5 years from transplant date.|Analysis was per protocol.|||months||Full Range|Mean
2807029|NCT00472030|Secondary|Change in Histamine Release Assay Following Treatment With Omalizumab.|The histamine release assay measures the release of histamine which occurs upon stimulation of basophilic granulocytes depending upon their sensitivity to an allergen.|Up to 24 weeks|We were unable to complete this assay in our research subjects due to technical difficulties.||||||
2812678|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation||over 13 weeks|All randomized participants.|||participants|||Number
2807030|NCT00472030|Secondary|Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16||Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||units per milliliter|||Number
2807031|NCT00472030|Primary|Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy.|The total dose of prednisone required to control the bullous pemphigoid at week 4, 8 and 24 weeks was to be calculated in both arms of this study.|Week 4, Week 8 and Week 24|Neither subject required treatment with Prednisone. Since we did not enroll any subject in the Prednisone Standard Therapy Treatment Arm we do not have any measurements for this outcome||||||
2807032|NCT00472030|Primary|Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.|Measurement of total body surface area affected by bullous pemphigoid active skin disease(active erosions, blisters, and/or lesions) was measured at Day 0 (prior to treatment with Omalizumab) and at 24 weeks (24 weeks is end of study).|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||percentage of active skin disease|||Number
2807033|NCT00472030|Secondary|Decrease in Eosinophil Levels Following Treatment With Omalizumab.|The subject's eosinophil count measured at baseline was compared to the eosinophil count at week 8. A normal eosinophil count at the University of Iowa Hospital lab is 0-0.4 cells per microliter|Baseline, 24 weeks.|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||cells/microliter|||Number
2807034|NCT00472030|Secondary|Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.|Anti-BP180 IgG levels were completed using an Elisa assay. Anti-BP180 IgG levels were obtained prior to baseline and at week 16|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||units per milliliter|||Number
2807035|NCT00472030|Primary|Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.|The study subject underwent physical examination and was assessed for cessation of new blister formation via physical examination and photography.|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.|||weeks|||Number
2807036|NCT00471822|Secondary|Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors|Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. 'n' signifies those participants who were evaluated for the respective risk factor.|||Percentage of Participants|||Number
2807037|NCT00471822|Secondary|Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril|Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.|Day 1|Evaluable population included all participants who met inclusion and exclusion criteria for the study.|||Percentage of Participants|||Number
2807038|NCT00471822|Secondary|Antibiotic-Resistant Streptococcus Pneumoniae Strains|Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.|||Percentage of Carrier Participants|||Number
2807039|NCT00471822|Secondary|Serotype Distribution of Streptococcus Pneumoniae Isolates|Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.|||Percentage of Carrier Participants|||Number
2807040|NCT00471822|Primary|Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx|Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study.|||Percentage of Participants|||Number
2807181|NCT00470470|Secondary|Time to Progression|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. Time to progression will be estimated using the Kaplan-Meier method.|Time from the treatment start to the date of disease progression||||weeks||Inter-Quartile Range|Mean
2807041|NCT00471718|Primary|Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease|Patients with a minimum 50% decline in PSA from pre-treatment baseline, confirmed by a second PSA 4 or more weeks later, measured in nanograms per milliliter of blood.|after four weeks|Men with non-measurable disease: all other lesions, bone lesions, leptomeningeal disease, cystic lesions, abdominal masses that are not followed by imaging techniques|||participants|||Number
2807042|NCT00471718|Secondary|Safety Profile Based on Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening or disabling, grade 5 = death)following NCI Common Toxicity Criteria|at 30 days after final treatment dose||||patients|||Number
2807043|NCT00471718|Secondary|Overall Survival|Number of weeks from the date the patient started study drug to the date of the patient's death.|date on study to date of death from any cause|At the time of this analysis, all 27 patients were deceased due to progressive prostate cancer.|||Weeks||95% Confidence Interval|Median
2807044|NCT00471718|Secondary|Median Time to Tumor Progression|"Number of weeks from the date the patient started study drug to the date of the patient's tumor progression documented radiographically or by PSA testing.~Tumor progression is measured at baseline and after two 28-day cycles"|date on study to date of progression|Patients who received treatment and who were available for measurement of tumor or who available for PSA testing|||Weeks||95% Confidence Interval|Median
2807045|NCT00471718|Secondary|Number of Patients With Objective Response (CR & PR) by RECIST|Number of participants in each best tumor response category, RECIST criteria (v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in sum longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in sum LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of smallest sum of the LD of target lesions.|after four weeks|Participants with measurable disease who completed at least one cycle of treatment with tumor assessment.|||participants|||Number
2807046|NCT00471718|Primary|Maximum Tolerated Dose (MTD)|MTD is determined by the 3+3 study design, in which patients are enrolled in cohorts of 3. In any dose cohort, if 1 patient of 3 experience dose-limiting toxicity (DLT), three additional patients will be enrolled at the same dose level. Whenever >=2 of 6 subjects experience a DLT, then the maximum tolerated dose (MTD) has been exceeded. The MTD is generally one dose below that at which DLT occurs in >= 2 of 6 subjects in any given cohort.|up to four weeks|Phase I patients who received treatment|||mg twice a day|||Number
2807047|NCT00471705|Primary|Failure|At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment|Until 3 months posttreatment||||participants|||Number
2807048|NCT00471705|Secondary|Recurrence|Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.|Until 6 months post-treatment||||Participants|||Number
2807049|NCT00471705|Primary|Complete Clinical Response|"Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.~Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment."|Until 6 months posttreatment|The efficacy of the treatments was calculated by intention to treat and by protocol.|||participants|||Number
2807050|NCT00471536|Secondary|Survival Time|The distribution of survival times will be estimated using the Kaplan-Meier method.|Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration|all participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2807051|NCT00471536|Secondary|Time to Disease Progression|The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.|Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration|All participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2807052|NCT00471536|Secondary|Duration of Response|The distribution of response durations will be estimated using the Kaplan-Meier method.|From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year|There were no responses.||||||
2807053|NCT00471536|Secondary|Confirmed Tumor Response (CR and PR)|Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.|Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year||||participants|||Number
2807054|NCT00471536|Secondary|Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.|Every 4 weeks during treatment (maximum duration was 44 weeks)|Eighteen of the 19 participants accrued to the study were evaluable for adverse events.|||participants|||Number
2807055|NCT00471536|Primary|Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])|"Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria:~A Complete Response (CR) requires the disappearance of all target lesions.~A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement.~All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response."|Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.|All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.|||participants|||Number
2807056|NCT00471497|Secondary|Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months|||||||
2807059|NCT00471497|Primary|Molecular Response Rate (MMR) at 12 Months|Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson protooncogene)|Baseline, 12 months|Patients in the Full Analysis Set (FAS) were analyzed according to the treatment they were randomized to regardless of actual treatment received.|||Percentage of participants||95% Confidence Interval|Number
2807060|NCT00471445|Primary|Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo|"Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average pain, numbness, or tingling in their hands and feet over the past 24 hours on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain)."|Week 6 - Baseline||||units on a scale||95% Confidence Interval|Mean
2807061|NCT00471380|Primary|Intra Ocular Pressure (IOP)|Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points|Baseline, end of each period (week 8, week 16, week 24)||||mm Hg (millimeters mercury)*week||Standard Deviation|Mean
2807062|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2807063|NCT00471354|Secondary|CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2807064|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2807065|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2807066|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores|Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2807067|NCT00471354|Secondary|Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).|||Spearman Correlation Coefficient|||Number
2807068|NCT00471354|Primary|Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).|||Spearman Correlation Coefficient|||Number
2807078|NCT00471315|Primary|The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.|The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.|3 months||||units on a scale||Standard Deviation|Mean
2807069|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||Percentage of Participants||95% Confidence Interval|Number
2807070|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.|||Percentage of Participants||95% Confidence Interval|Number
2807071|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The best overall response (CR/PR) must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||Participants|||Number
2807072|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Central Radiology Review During Primary Analysis (Data Cut-off: June, 2008)|The best overall response is the best response recorded from randomization until disease progression. The CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.|||Participants|||Number
2807073|NCT00471328|Primary|Progression-free Survival (PFS) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|PFS is defined as the time from the first date of cross-over to nilotinib therapy from the control arm to the date of the first observation of documented disease progression. Tumor assessment was based on the local investigator's measurement using Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||days||95% Confidence Interval|Median
2807074|NCT00471328|Secondary|Overall Survival for Treatment Crossover Analysis Set|For patients who crossed-over to nilotinib from the control arm, the overall survival was the time from the first dose date of nilotinib after switching from control arm to the date of death due to any cause. If death was not observed, the OS was censored at the latest date the patient was known to be alive.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.|||days||95% Confidence Interval|Median
2807075|NCT00471328|Secondary|Overall Survival During Core and Extension Phases of the Study|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact. This analysis included both Core and Extension data as well as survival follow up data.|Up to 50 months (including core, extension and follow up period)|Core Full Analysis Set (Core FAS): included all randomized patients included in the Core study. Analyses based on Core FAS does not account for treatment crossover i.e.pooling all data both before and after crossover. This analysis set was used to conduct an overall survival analysis.|||days||95% Confidence Interval|Median
2807076|NCT00471328|Secondary|Overall Survival Based on Primary Analysis (Data Cut-off:June, 2008)|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized participants and was used as the primary efficacy population.|||days||95% Confidence Interval|Median
2807077|NCT00471328|Primary|Progression-free Survival (PFS) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.|||days||95% Confidence Interval|Median
2807079|NCT00471315|Secondary|Toleration of the Medication as Measured by the Duloxetine Compliance Rate|The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.|3 Months||||participants|||Number
2807081|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Satisfaction With Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.|||Units on a scale||Full Range|Median
2807082|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Feelings About Side Effects|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.|||Units on a scale||Full Range|Median
2807083|NCT00471276|Secondary|Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.|||Units on a scale||Full Range|Median
2807084|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807085|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807086|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807087|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807098|NCT00471276|Secondary|Number of Participants With Clinical Benefit|The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (>) 6 months according to RECIST. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT|||Participants|||Number
2807182|NCT00470470|Primary|Objective Response Rate|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.|Every 6 weeks for the first 3 courses and then every 12 weeks thereafter||||participants|||Number
2807088|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807089|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807090|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807091|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807092|NCT00471276|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.|||Units on a scale||Full Range|Median
2807093|NCT00471276|Secondary|Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy|Number of participants with objective response based assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT; N=participants who received at least 2 lines of prior chemotherapy for advanced/metastatic disease and had post baseline tumor assessment|||Participants|||Number
2807094|NCT00471276|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS (Months)=(death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline until death (up to Month 34)|ITT|||Months||95% Confidence Interval|Median
2807095|NCT00471276|Secondary|Duration of Response (DR)|Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first. DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Baseline up to Month 34 or early termination|ITT; N=participants with objective response|||Weeks||Full Range|Median
2807096|NCT00471276|Secondary|Progression-Free Survival (PFS)|Time from date of randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months)=(first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 34|ITT|||Months||95% Confidence Interval|Median
2807097|NCT00471276|Secondary|Number of Participants With Objective Response of Superficial Lesions|Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST. Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.|Baseline, every 4 weeks up to Month 34|ITT; Number of participants analyzed equaled (N =) participants who had superficial lesions with post baseline follow-up assessments of those lesions.|||Participants|||Number
2807099|NCT00471276|Primary|Number of Participants With Objective Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|Intent to Treat (ITT) population: all enrolled participants|||Participants|||Number
2807100|NCT00471237|Secondary|Time Required to Achieve Maximum Concentration of Ronacaleret in Blood (Tmax)|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic parameters population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
2807101|NCT00471237|Secondary|Maximum Blood Concentration (Cmax) of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, Cmax of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic parameter population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2807102|NCT00471237|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-t) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC 0-tau) of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive pharmacokinetic and pharmacodynamics subgroup of participants were analyzed by standard noncompartmental methods. Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Following log transformation, AUC(0-t) and AUC(0-τ) of ronacaleret were separately analyzed by ANOVA using mixed effects model, fitting treatment and country/region as fixed effects.|Pre-dose (0.0 h) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic Parameters Population comprised of any participant in the pharmacokinetic concentration population who provided pharmacokinetic parameters. Only those participants available at the specified time points were analyzed.|||nanogram*hour per millilitre (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2807103|NCT00471237|Secondary|Blood Concentrations of Ronacaleret|Blood samples were collected and analyzed for concentrations of ronacaleret. The individual blood concentration-time data from the intensive PK-PD subgroup of participants were analyzed by standard noncompartmental methods. Blood concentrations of ronacaleret were reported.|Pre-dose (0.0 hour [h]) and 12 h post dose at Week 4, 20, 40 min, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 1-4, 8-12, and 24 h at Month 3, 6 and 12|Pharmacokinetic Concentration Population comprised of any Intent-to-Treat participants for whom a SB-751689 pharmacokinetic blood sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
2807104|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Bone Specific Alkaline Phosphatase (BALP)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of BALP.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||mcg/L||Standard Error|Least Squares Mean
2807105|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Procollagen Type 1 N-terminal Propeptide (P1NP)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of P1NP.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent to treat population. Only those participants available at the specified time points were analyzed.|||Microgram per Litre (mcg/L)||Standard Error|Least Squares Mean
2807106|NCT00471237|Secondary|Biochemical Markers of Bone Turnover: Levels of C-terminal Telopeptide α1 Chain of Type 1 Collagen (CTX1)|Blood samples were collected at Baseline (Day 0), Week 4, Month 3, 6, and 12 for measurement of CTX1.|Baseline (Day 0), Week 4, Month 3, 6, and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||nanogram per litre (ng/L)||Standard Error|Least Squares Mean
2807107|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in Cortical Thickness at the Hip as Measured by QCT Scans|Percent change in thickness of femur neck cortical VOI thickness and trochanter cortical VOI thickness were at Month 12 measured by QCT were reported. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in cortical thickness||Standard Deviation|Mean
2807108|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip as Measured by QCT Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in mg/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in BMD||Standard Deviation|Mean
2807162|NCT00470626|Secondary|Mean Time to Retrieval Attempt|"Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made.~A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made."|up to 12 months||||days||Standard Deviation|Mean
2807109|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Total Vertebra Integral VOI at the Lumbar Spine as Measured by QCT Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular VOI are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in VOI||Standard Deviation|Mean
2807110|NCT00471237|Secondary|Percent Change From Baseline to Month 12 in the Volumetric Integral, Cortical, and Trabecular Density (BMD) at the Hip and Lumbar Spine as Measured by Quantitative Computer Tomography (QCT) Scans|QCT is a three-dimensional non-projectional technique to quantify BMD with a number of advantages to other densitometric techniques. Cortical and trabecular bone can be separated, trabecular volume of interest (VOI) are largely independent of degenerative changes in the spine and 3 dimensional geometric parameters can be determined. BMD as measured by QCT is a true density measured in g/cm^3 in contrast to DXA Which determines an areal density measured in g/cm^2. Baseline values were assessed on Day 0. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline to month 12 in the volumetric integral, cortical, and trabecular density (BMD) at the hip and lumbar spine measured by QCT were reported.|Baseline (Day 0) and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Percent change in BMD||Standard Deviation|Mean
2807111|NCT00471237|Secondary|Number of Participants Who Remained the Same or Had Any Improvement in DXA BMD (> Baseline)|Responder rate of participants who remained the same or had any improvement as compared to baseline in DXA BMD of vertebra, femur and vertebra plus femur were reported. Baseline values were assessed on Day 0. Percent change (improvement) from Baseline was computed as (change from baseline / baseline value) * 100%.|Baseline (Day 0), Month 5, 6 and 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2807112|NCT00471237|Secondary|Percent Change From Baseline to Months 6 and 12 in BMD Measured by DXA Scans of the Hip (Total Hip, Femoral Neck and Trochanter).|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 and 12 in aBMD of hip (total hip, femoral neck and trochanter) were reported.|Baseline (Day 0), Month 6 and Month 12|Intent-to-Treat population. Only those participants available at the specified time points were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented.|||Percent change in BMD||Standard Error|Least Squares Mean
2807113|NCT00471237|Secondary|Percent Change From Baseline to Month 6 in BMD Measured by DXA Scans of the Lumbar Spine (L1-L4)|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Baseline values were assessed on Day 0. Percent Change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from baseline to month 6 in aBMD was reported.|Baseline (Day 0) and Month 6|Intent to Treat Population. Only those participants available at the specified time point were analyzed. Participants from Teriparatide, 20 mcg, SC injection, OD arm were excluded from the analysis, since these participants were not randomized and were disproportionately represented.|||percent change in BMD||Standard Error|Least Squares Mean
2807114|NCT00471237|Primary|Mean Change From Baseline in Weight|Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.|Baseline (Day 0), Month 6, 12 and early withdrawal|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Kilogram||Standard Deviation|Mean
2807115|NCT00471237|Primary|Mean Change From Baseline in Height|Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.|Baseline (Day 0), Month 6, 12 and early withdrawal|Intent-to-Treat population. Only those participants available at the specified time points were analyzed.|||Centimeter||Standard Deviation|Mean
2807116|NCT00471237|Primary|Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event|Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.|Up to 12 months|Intent-to-Treat population.|||Participants|||Count of Participants
2807117|NCT00471237|Primary|Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit|The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (> 30 millimeter of mercury [mmHg] decrease from Baseline, > 30 mmHg increase from Baseline), diastolic blood pressure (> 20 mmHg decrease from Baseline and > 20 mmHg increase from Baseline) and heart rate (<45 and >120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 12 Months|Intent-to-Treat population.|||Participants|||Count of Participants
2807201|NCT00470158|Secondary|Percent Anemic||6 months|||||||
2807118|NCT00471237|Primary|Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit|The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.|Up to Month 12|Intent-to-Treat population.|||Participants|||Count of Participants
2807119|NCT00471237|Primary|Number of Participants Withdrew Due to Hypercalcemia|A confirmed albumin-adjusted serum calcium pre-dose value of >11.0 mg/dL or post-dose value of >12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.|Up to Month 12|Intent-to-Treat population.|||Participants|||Count of Participants
2807120|NCT00471237|Primary|Number of Participants With Hypercalcemia|Participants with albumin-adjusted serum calcium pre-dose values of >11.0 mg/ deciliter (dL) or post-dose values of >12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.|Up to Month 12|Intent-to-Treat population.|||Participants|||Count of Participants
2807121|NCT00471237|Primary|Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)|DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) * 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.|Baseline (Day 0) and 12 Months|Intent-to-Treat population comprised of any randomised or teriparatide participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. Teriparatide arm was excluded from the analysis, since these participants were not randomized and were disproportionately represented.|||Percent change in BMD||Standard Error|Least Squares Mean
2807122|NCT00471146|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months|||||||
2807123|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Millimeter (mm)||Standard Deviation|Mean
2807124|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2807125|NCT00471146|Secondary|Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2807126|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2807127|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2807128|NCT00471146|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline until death or at least 1 year after the randomization of last participant|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||Weeks||95% Confidence Interval|Median
2807129|NCT00471146|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, every 8 weeks until tumor progression or death|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2807130|NCT00471146|Secondary|Progression Free Survival (PFS)|"Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or at least 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
2807131|NCT00471146|Primary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or at least 1 year after the randomization of last participant|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
2807132|NCT00471107|Primary|Verbal Memory|The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).|24 hours|All subjects in this group for whom data were obtained were analyzed|||Words recalled||Standard Deviation|Mean
2807133|NCT00471081|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2807134|NCT00471081|Secondary|Number of Subjects Reporting Rash|Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2807135|NCT00471081|Secondary|Number of Subjects With New Onset Chronic Ilnesses (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2807136|NCT00471081|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end (Month 9)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2807137|NCT00471081|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Up to 1 month post-vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2807138|NCT00471081|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).|||Participants|||Count of Participants
2807139|NCT00471081|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).|||Participants|||Count of Participants
2807140|NCT00471081|Secondary|Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||μg/mL||95% Confidence Interval|Geometric Mean
2807141|NCT00471081|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).|At Month 1 (GSK 134612 s doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
2807142|NCT00471081|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
2807143|NCT00471081|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Titers||95% Confidence Interval|Geometric Mean
2807144|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.|At Month 1 (GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
2807145|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Month 1 (for GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
2807146|NCT00471081|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1 (for GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Titers||95% Confidence Interval|Geometric Mean
2807147|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|At Month 1 (for GSK 134612 2 doses Group only) and Month 4|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).|||Participants|||Count of Participants
2807148|NCT00471081|Secondary|Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|One month after the first dose (at Month 1)|This analysis was performed on subjects who have received the Month 0 vaccination in the GSK 134612 2 doses Group from the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2807202|NCT00470158|Secondary|Change in Zinc Status||6 months|||||||
2807203|NCT00470158|Secondary|Change in Hemoglobin||6 months|||||||
2807149|NCT00471081|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|One month after the last dose (at Month 4)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2807150|NCT00471068|Primary|Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment|IOP measured at week 6 minus IOP measured at baseline|At week 0 and week 6||||millimeters mercury (mm Hg)||Standard Deviation|Mean
2807151|NCT00470847|Secondary|Overall Survival|Overall average length of participant survival after protocol initiation|Participants were followed for an average of 3.8 years||||Months||Full Range|Median
2807152|NCT00470847|Secondary|Percentage of Participants Having Non-Central Nervous System Sites as the Site of First Progression||5 years||||percentage of participants|||Number
2807153|NCT00470847|Secondary|Percentage of Participants Having Central Nervous System as the Site of the First Progression||5 years||||percentage of participants|||Number
2807154|NCT00470847|Secondary|Objective Response Rate in Central Nervous System Sites|Objective Response Rate was defined using volumetric response as the following: Complete Response (CR) is the disappearance of all target lesions, stable/responsive non-target lesions, and no new lesions. Partial response (PR) is at least a 50% reduction in the sum of the target lesions, stable/responsive non-target lesions, and no new lesions. Stable Disease (SD) is neither CR PR or Progressive Disease (PD). And Progressive Disease (PD) is at least 40% increase in sum of target lesionsor the appearance of any new lesion >=6mm in the longest dimension. If a patient progressed in a non-central nervous system(CNS) site first, died, or withdrew from the study for any reason after the first dose of drug was administered, and before a CR or PR in the central nervous system was determined, she was considered a CNS non-responder.|5 years|28 participants had measurable disease out of the 35 participants enrolled.|||percentage of participants||95% Confidence Interval|Number
2807155|NCT00470847|Secondary|Progression Free Survival|Progression Free Survival is the time from date of start of treatment to the date of the first documented progression or death due to any cause. If a patient has not progressed or died, progression free survival is censored at the time of last tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years||||months||Full Range|Median
2807156|NCT00470847|Primary|The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.|The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects.|5 Years||||milligrams|||Number
2807157|NCT00470834|Secondary|Number of Participants With Metastatic Disease|Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.|Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)|ITT Population|||participants|||Number
2807158|NCT00470834|Secondary|Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42|Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 6, 12, 18, 21, and 42|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Nanograms per milliliter (ng/mL)||Full Range|Median
2807159|NCT00470834|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.|Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)|ITT Population|||participants|||Number
2807160|NCT00470834|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)|ITT Population. Data were not summarized for censored participants (no treatment failure).|||Days||Standard Deviation|Mean
2807161|NCT00470834|Primary|Time to Disease Progression|Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment. Data were not summarized for censored participants (no disease progression).|||Days||Standard Deviation|Mean
2807163|NCT00470626|Secondary|Successful Retrieval|Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).|up to 12 months|129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient’s medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients.|||successful retrievals|||Number
2807164|NCT00470626|Primary|Major Adverse Event|Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.|up to 12 months||||participants|||Number
2807165|NCT00470600|Secondary|Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).|Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.|Study hour-6 to hour-28|Demand of narcotic use was determined by PCA records or by chart if patient requested and not via PCA.|||milligrams||Standard Deviation|Mean
2807166|NCT00470600|Secondary|Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)|"Measurement of the patient's self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.|||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
2807167|NCT00470600|Primary|AUC-VAS With Movement (Post-operative Period, Hour-6-28)|"Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery [variable since every surgery has a unique length of time even if it is the same procedure] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.|||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
2807168|NCT00470548|Secondary|Number of Participants With Disease Control|Disease control is complete response plus partial response plus stable disease from the start of treatment to death or disease progression.|Up to 2 years||||Participants|||Count of Participants
2807169|NCT00470548|Secondary|Number of Participants With Partial Response|At least a 30% decrease in the sum of the longest diameter of target lesions|Up to 2 years||||Participants|||Count of Participants
2807170|NCT00470548|Secondary|Number of Participants With Stable Disease|Stable Disease is measured from the start of the treatment until the criteria for disease progression are met. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years||||Participants|||Count of Participants
2807171|NCT00470548|Secondary|Number of Participants With Complete Response|Per RECIST criteria, complete response (CR) is defined as the disappearance of all target lesions.|Up to 2 years||||participants|||Number
2807172|NCT00470548|Secondary|Duration of Overall Survival|From time of enrollment to the first observation of disease progression or death.|Up to 2 years|Of the 12 patients in the phase I component 10 were assessable for response. In the phase II component, 31 of 37 patients were evaluable for response.|||months||Standard Error|Median
2807173|NCT00470548|Primary|Number of Patients With Toxicities|Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.|Up to 1 year||||Participants|||Count of Participants
2807174|NCT00470548|Primary|Number of Participants With Dose Limiting Toxicities|Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.|Up to21 days|At dose level 1, 2 and 3 three participants were treated with no dose limiting toxicities. Three additional participants were treated at dose level 3 with no dose limiting toxicities.|||participants|||Number
2807175|NCT00470535|Secondary|Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade||At Baseline|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
2807176|NCT00470535|Secondary|Correlation of Smoking Status With Overall Survival||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
2807177|NCT00470535|Secondary|Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
2807178|NCT00470535|Secondary|Median Overall Survival||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.||||||
2807183|NCT00470418|Secondary|Changes From Baseline in Clinical Measures of Cognition at Terminal Visit|Mini-Mental Status Exam (MMSE) 0(worst)-30(best); ADAS-cog 0 (best cognitive performance across multiple domains) - 70(worst); Activities of Daily Living (ADCS-ADL) 0(least capable of function in daily and instrumental activities)-54(best)|baseline and six weeks||||units on a scale||Standard Deviation|Mean
2807184|NCT00470418|Primary|Safety Assessments: Number of Participants With Adverse Events|vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram|Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks||||Participants|||Count of Participants
2807185|NCT00470392|Secondary|Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2|Based upon upregulated mRNA expression of MyxA in 1 out of 7 patients treated with Imiquimod, a list of alternative target genes responsive to Imiquimod was generated. The target mRNAs examined included GRAMD1A, IL2RA, TGHD1, DMXL2. The target gene was consider upregulated if there was a 1.5 fold increase in the mRNA expression of the target gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment||||participants|||Number
2807186|NCT00470392|Secondary|Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment|The PASI is a disease burden measure that integrates area, erythema, thickness and scale of each target lesion. The severity score for each region is calculated by adding the scores for redness, thickness and scale (each of which are graded from 0 to 4). The maximum severity score is 12. The higher the PASI, the worse the disease. Thus, an improvement in PASI score is a lower score than the pre-treatment PASI.|2 weeks after Imiquimod and UVB|Per protocol.|||participants|||Number
2807187|NCT00470392|Primary|Number of Subjects With Elevated MyxA|Lesions were treated with either Imiquimod or Clobetasol cream. Lesions were subsequently treated with UVB and biopsied. From the biopsy samples obtained from the Imiquimod arm, quantitative PCR was performed to measure levels of Myx A, an imiquimod response gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment|Per protocol.|||participants|||Number
2807188|NCT00470366|Secondary|Number of Patients With Treatment Related Toxicity|Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0|3 years||||Participants|||Count of Participants
2807189|NCT00470366|Secondary|Percentage of Participants With Progression Free Survival|Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years||||percentage of patients||95% Confidence Interval|Number
2807190|NCT00470366|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 8 years||||years||Full Range|Median
2807191|NCT00470366|Primary|Rate of Complete Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|3 years||||Participants|||Count of Participants
2807192|NCT00470301|Primary|Pathologic Complete Response Rate (pCR) Evaluated Using RECIST (Phase II)|An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.|Up to 5 years||||participants||95% Confidence Interval|Number
2807193|NCT00470301|Primary|Recommended Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I)||2 weeks|||||||
2807194|NCT00470275|Primary|Response|Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|the first six cycles of study chemotherapy (126 days)||||participants|||Number
2807195|NCT00470262|Secondary|IMCL|Intramyocellular lipid was measured using immunohistochemistry (using oil Red O staining) in muscle biopsy specimens. Oil red O-stained muscle sections were magnified with an Olympus Provis (Tokyo, Japan) light microscope, and images were digitally captured by using a connected charge-coupled device camera (Sony, Tokyo, Japan). Fiber-typed and oil red O-stained fibers were matched. The oil red O staining intensity of either type 1 or 2 muscle fibers was quantified using National Institutes of Health Image program (http://rsb.info.nih.gov/nih-image/). By adjusting a density threshold, the software was set to recognize the presence of one fat droplet only if its highlighted surface was exceeding 0.40 μm2 or larger. Muscle lipid content was calculated by total area of lipid droplets in a given muscle fiber divided by the total area of the same fiber. The mean number of fibers analyzed per sample was 40 for type 1 and 2 muscle fibers|3 months||||% of lipid area stained||Standard Deviation|Mean
2807196|NCT00470262|Primary|Insulin Sensitivity|Insulin sensitivity was measure through frequently sampled intravenous glucose tolerance test. Subjects presented to research center fasting. Blood samples were collected at -21, -11, and -1 minutes. At time t=0 initiates the start of the IVGTT and the injection of glucose into the non-sampling arm. The glucose dose was calculated as 11.4g/m2 of body surface area, given as a 50% dextrose solution. This glucose injection was administered over 60 seconds or less. At time t=20 minutes, an insulin dose of 0.04u/kg was administered over 30 seconds. Blood samples were collected at times t=2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140, 160, and 180. If blood sugar did not return to a steady state the test was continued to t= 210 or t= 240.|3 months||||mg*kg^-1*min^-1||Standard Deviation|Mean
2807197|NCT00470184|Secondary|Quality of Life Improved Rate||5.5 weeks|evaluable patients|||percentage of patients||95% Confidence Interval|Number
2807198|NCT00470184|Secondary|Median Time to Progression||5.5 weeks|Evaluable patients|||months||95% Confidence Interval|Number
2807199|NCT00470184|Secondary|Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1||5.5 weeks|evaluable patients|||percentage of patients||95% Confidence Interval|Number
2807200|NCT00470184|Primary|Complete Response||5.5 weeks|Evaluable Patients|||percentage of patients||95% Confidence Interval|Number
2807205|NCT00470106|Secondary|Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).|This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test.|Assessments at endpoint (12 weeks).||||number correct||Standard Deviation|Mean
2807206|NCT00470106|Primary|Mean Test Scores for Facial Emotion Identification.|This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.|Assessments for end point (12 weeks).||||number of correct answers||Standard Deviation|Mean
2807207|NCT00470093|Primary|Impact of Treatment on Growth of Myeloma Cells|Percentage change in growth of in vitro myeloma cells from baseline to end of study.|Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study|Zero participants tolerated protocol therapy and the research sample blood draws were therefore not completed as planned. Because of this, the data from this outcome could not be collected.||||||
2807208|NCT00470093|Primary|Optimal Dose of Interleukin-6|Maximum tolerated dose found using a standard 3+3 dose escalation model.|Up to 5 months|This outcome cannot be evaluated as zero participants tolerated the study regimen. All participants were enrolled on the 2.5 mg arm and a maximum tolerated dose was not found.||||||
2807209|NCT00470093|Primary|Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events|Number of participants who discontinued the protocol due to adverse events.|Up to 5 months||||Participants|||Count of Participants
2807210|NCT00470093|Primary|Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.|Number of participants with partial or complete response by Bladé criteria where partial response is defined as a >= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 5 months||||Participants|||Count of Participants
2807211|NCT00470067|Primary|Response (Complete and Partial)|Response Rate|Every 28 days|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2807212|NCT00470054|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|"The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Assessed during treatment|All 44 participants who received treatment were analyzed (including ineligible participants).|||participants|||Number
2807213|NCT00470054|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)|All eligible participants were analyzed.|||weeks||95% Confidence Interval|Median
2807214|NCT00470054|Secondary|Response to Therapy|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria."|Assessed every 2 cycles (up to 3 years)|All eligible participants were analyzed.|||participants|||Number
2807215|NCT00470054|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.~Progression is defined as in the primary outcome measure."|Time from registration to progression (up to 3 years)|All eligible participants were analyzed.|||weeks||95% Confidence Interval|Median
2807216|NCT00470054|Primary|6 Week Progression Free Survival|"Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.~Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions."|6 weeks|All eligible participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
2807217|NCT00469911|Primary|Correlation Co-efficient Between MRS Spectroscopy and Endomyocardial Biopsy in Heart Transplant Participants|Participants first had MRS spectroscopy then the MRS spectroscopy images were compared to endomyocardial biopsy|2 to 10 days||||correlation co-efficient|||Number
2807218|NCT00469898|Secondary|Overall Survival||On study date to death||||Months||Full Range|Median
2807219|NCT00469898|Secondary|Time to Progression|Time to progression in months|9.9 months (on study date to progression)|Patients who has progression|||Months|Participants|Full Range|Median
2807220|NCT00469898|Secondary|Number of Patients With Adverse Events|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event|date off treatment or progression of disease, up to 18 weeks||||participants|||Number
2807221|NCT00469898|Primary|Patient Response|"Patient response to treatment:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|1.66 months (average duration, on treatment date to best response date)||||participants|||Number
2807222|NCT00469859|Primary|>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points|FLT3 inhibition is determined in patients receiving lestaurtinib by measuring FLT3 plasma inhibitory activity (PIA). For PIA predictive modeling, a random effects linear regression model will be used to describe the relationship between PIA and Pharmacokinetic (PK) levels for each of the 5 trough plasma samples collected for each patient|Course 1 day 7, day 14, day 21, and day 28.||||participants|||Number
2807223|NCT00469859|Primary|Dose-limiting Toxicity|Number of patients with dose-limiting toxicity (DLT)|28 days||||participants|||Number
2807225|NCT00469833|Primary|Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes||||pmol/L||Standard Error|Mean
2807226|NCT00469833|Primary|C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes||||nmol/L||Standard Error|Mean
2807227|NCT00469833|Primary|ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes||||pmol/min||Standard Error|Mean
2807228|NCT00469612|Secondary|Refractive Error||Every 10th visit|Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.||||||
2807229|NCT00469612|Primary|Contrast Sensitivity Function||Every 5th visit|Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.||||||
2807230|NCT00469612|Primary|Visual Acuity||Every 5th visit|Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.||||||
2807231|NCT00469508|Other Pre-specified|BDI Score|Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.|From baseline to end of treatment period (week 12).|Intention to treat, LOCF|||units on a scale||Standard Deviation|Mean
2807232|NCT00469508|Other Pre-specified|VAS Score|To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.|baseline and last observation during the 12 week treatment period|Intention to treat, LOCF|||units on a scale||Standard Deviation|Mean
2807233|NCT00469508|Secondary|Retention|The number of persons who completed the medication phase of the trial (12 weeks of medication).|12 weeks|Intention to treat|||participants|||Number
2807234|NCT00469508|Primary|Clean Urine Drug Screen|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|From randomization to end of week 12|Intention to treat|||Clean urine drug screens|Urine drug screens|Standard Deviation|Mean
2807235|NCT00469456|Secondary|Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12|The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication.|Baseline to Week 12|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
2807236|NCT00469456|Primary|Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12|FLCI is a standardized & validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information & to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete.|Baseline to Week 12|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population will consist of all patients in the Safety Population who had at least one post-Baseline assessment of the primary efficacy parameter, FLCI. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
2807238|NCT00469274|Primary|Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria.|Defined as a positive nasopharyngeal culture or PCR for B. pertussis at any time point, a two-fold rise in the anti-PT IgG titer between acute and convalescent sera, or a single acute or convalescent anti-PT IgG titer of ≥94 EU. Post hoc, a modified definition was devised because of concern that the serologic criteria used in the primary definition might actually represent acquisition of pertussis infection prior to the intervention. The modified definition of pertussis excluded an acute anti-PT IgG titer of ≥94 EU and an acute nasopharyngeal swab that was positive for B. pertussis by PCR.|In the 21 days following exposure identification||||participants|||Number
2807239|NCT00469209|Secondary|Time to Toxicity|The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.|Baseline to event occurence (assessed weekly first 30 days)|||||||
2807240|NCT00469209|Primary|Number of Patients Reaching Complete Response (CR)|Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.|Baseline through Day 180, with assessments at Day 90 and Day 180|Analysis was per protocol.|||participants|||Number
2807241|NCT00469092|Secondary|Number of Subjects Reporting Treatment Emergent Adverse Events|Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.|Weeks 0-26|The safety analysis population consists of all subjects exposed to trial products.|||participants|||Number
2807242|NCT00469092|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|Weeks 0-26||||events|||Number
2807243|NCT00469092|Secondary|Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)|Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||scores on a scale||Standard Error|Mean
2807244|NCT00469092|Secondary|Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)|The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||participants|||Number
2807245|NCT00469092|Secondary|9-point Self-measured Plasma Glucose Profiles|Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||mmol/L||Standard Error|Mean
2807246|NCT00469092|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.|After 26 weeks of treatment|Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.|||percentage of total haemoglobin||Standard Deviation|Least Squares Mean
2807247|NCT00469079|Secondary|Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.|Changes in craving and withdrawal symptoms were assessed at the time of discontinuation of usual brand cigarettes (i.e., baseline compared to week 1). Assessments were made using the Minnesota Nicotine Withdrawal Scale, which measures abstinence effects from usual brand cigarettes. Total Score: Range of scores is from 0 to 28. All items with the exclusion of craving are summed. Craving Score: Range of score is from 0 to 4. A higher score would indicate more severe withdrawal.|Baseline and 1 week|All subjects completing the intervention|||units on a scale||Standard Error|Mean
2807248|NCT00469079|Primary|Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.|This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (<35 ng/mL).|12 weeks|Intent to treat model.|||participants|||Number
2811766|NCT00439374|Secondary|Number of Neonates Experiencing Seizures|Number of neonates experiencing seizures from delivery to hospital discharge|Delivery through neonatal discharge|Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.|||Participants|||Count of Participants
2807249|NCT00469079|Primary|Product Use at Week 4 of Intervention|Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.|4 weeks|All subjects who completed intervention.|||uses per day||Standard Error|Least Squares Mean
2807250|NCT00469079|Primary|Toxicant Exposure by Products|Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.|Baseline, 4 weeks|All subjects who continued in the protocol were analyzed. Non-parametric Kruskal-Wallis method of analysis was used.|||ng/ml||95% Confidence Interval|Geometric Mean
2807251|NCT00468910|Other Pre-specified|Platelet Cyclooxygenase (COX) Activity as Measured by a Peroxidase-based COX Enzyme Activity Assay|Evaluate the effect of aspirin on platelet COX activity as measured by a peroxidase-based Cox enzyme activity assay.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||pg/ml||Standard Deviation|Mean
2807252|NCT00468910|Secondary|Rectal Prostaglandin Levels as Measured by ELISA|Evaluate the effect of aspirin on rectal prostaglandin levels.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||pg/ml||Standard Deviation|Mean
2807253|NCT00468910|Secondary|Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67|Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of Ki-67. These were performed on samples that had been previously analyzed for 4D-ELF.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||Percentage of Total Cells||Standard Deviation|Mean
2807254|NCT00468910|Secondary|Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3|Evaluate the effect of aspirin on colonic epithelial apoptosis and cell proliferation as assessed by immunohistochemical detection of cleaved caspase 3 .These were performed on samples that had been previously analyzed for 4D-ELF.|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||Percentage of Total Cells||Standard Deviation|Mean
2807255|NCT00468910|Primary|Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.|"Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue.~SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture"|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa|||unitless||Standard Deviation|Mean
2807256|NCT00468910|Primary|Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.|"Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes.~Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture."|3 months from baseline colonoscopy to end of intervention.|Subjects at high risk for colorectal cancer (CRC) with a cancer-associated spectral marker signature in histologically normal colonic mucosa.|||micron^-1||Standard Deviation|Mean
2807257|NCT00468858|Secondary|Vaccine Response to DEN Antibody at Post Dose 2, Month 7|Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7|at month 7, post dose 2||||% of subjects||95% Confidence Interval|Number
2807258|NCT00468858|Secondary|Vaccine Response to DEN Antibody at Post Dose 1, Month 3|"Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody~S- = seronegative subjects (antibody titer <10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer >10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination~Vaccine response defined as: For initially seronegative subjects, antibody titer >10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) >4 fold the pre-vaccination antibody titer"|at month 3, post dose 1||||% of subjects||95% Confidence Interval|Number
2807259|NCT00468858|Secondary|Percent of Subjects With Neut. Sero-response to Each DEN Serotype|Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects|Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7||||percent of subject with attribute||95% Confidence Interval|Number
2807260|NCT00468858|Secondary|Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes|Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects|Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7||||% of subjects||95% Confidence Interval|Number
2807261|NCT00468858|Secondary|GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects|Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects|at month 7 (one month post dose 2)||||titers||95% Confidence Interval|Mean
2807262|NCT00468858|Secondary|Incidence of Suspected and Laboratory Confirmed Dengue|Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period|31-day (days 0-30) post-vaccination period and after 31-day period||||dengue fever cases|||Number
2807263|NCT00468858|Primary|Safety: Occurrence of Serious Adverse Events (SAEs)|Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose|6 months + 30 day follow-up period after last vaccine dose||||Participants|||Count of Participants
2807266|NCT00468845|Secondary|Total Clinically Meaningful Event (CME) Score|Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807267|NCT00468845|Secondary|Incidence of Chronic Post-operative Pain|Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.|3 and 6 Months PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit.|||Percentage of participants|||Number
2807268|NCT00468845|Other Pre-specified|Neuropathic Pain Symptom Inventory (NPSI)|Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807269|NCT00468845|Secondary|Time to Actual Discharge|Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.|Day 1 up to Day 7 PS|mITT|||Hours||Standard Error|Mean
2807270|NCT00468845|Secondary|Time to Meet Hospital Discharge Criteria|Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.|Day 1 up to Day 7 PS|mITT|||Hours||Standard Error|Mean
2807271|NCT00468845|Secondary|Quality of Life Using EuroQol (EQ-5D) Health State Profile|"Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata."|Discharge (day 3 up to day 7 PS) and day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807272|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807273|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807274|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 28 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 28 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807275|NCT00468845|Other Pre-specified|Incision Length Correlated With Worst Pain|Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.|Day 1|mITT|||Centimeter (cm)||Standard Error|Least Squares Mean
2807276|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - End of Treatment|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 1 up to Day 28 PS|Safety population|||Percentage of participants|||Number
2807277|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 14 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 14 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807278|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 7 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 7 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807321|NCT00468819|Primary|Terminal Elimination Half Life Estimates of Gadobutrol by Age Group|Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||hours||Inter-Quartile Range|Median
2807279|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Discharge|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Discharge (day 3 up to day 7 PS)|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807280|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 5 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 5 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807281|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 4 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 4 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807282|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 3 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 3 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807283|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 2 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 2 PS|mITT; N=number of evaluable participants analyzed;|||Percentage of participants|||Number
2807284|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 1 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1 PS|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807285|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Surgery Day|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1|mITT; N=number of evaluable participants analyzed|||Percentage of participants|||Number
2807286|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 28 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 28 PS|Safety population|||Percentage of participants|||Number
2807287|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 14 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 14 PS|Safety population|||Percentage of participants|||Number
2807288|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|"m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).~LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807289|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 7 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 7 PS|Safety population|||Percentage of participants|||Number
2807290|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Discharge|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Discharge (day 3 up to day 7 PS)|Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included.|||Percentage of participants|||Number
2807291|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2811790|NCT00439374|Primary|Number of Participants Delivering Before 37 Weeks Gestation|Number of participants delivering before 37 weeks gestation by indication|Delivery before 37 weeks gestation||||Participants|||Count of Participants
2807292|NCT00468845|Secondary|Sleep Interference|Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807293|NCT00468845|Secondary|Worst Daily Pain|Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.|Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Deviation|Mean
2807294|NCT00468845|Secondary|Average Daily Pain|Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807295|NCT00468845|Secondary|Timed Up-and-Go (TUG)|Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Seconds||Standard Error|Least Squares Mean
2807296|NCT00468845|Secondary|Percent Change From Baseline in Peak Expiratory Flow|Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.|||L/min||Standard Error|Least Squares Mean
2807297|NCT00468845|Secondary|Non-opioid Rescue Medication - Ibuprofen|The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Grams (g)||Standard Deviation|Mean
2807298|NCT00468845|Secondary|Anxiety Before and After Surgery|Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata|Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807299|NCT00468845|Secondary|Non-opioid Rescue Medication - Paracetamol|The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Grams (g)||Standard Deviation|Mean
2807300|NCT00468845|Secondary|Integrated Analgesic Score|The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|0-24, 24-48, 48-72 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807301|NCT00468845|Secondary|Total Cumulative Dose of Opioids Following Surgery|Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|24, 48 Hours PS, Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||milligram (mg)||Standard Error|Least Squares Mean
2807302|NCT00468845|Secondary|Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay|Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807303|NCT00468845|Secondary|Current Pain at Rest|Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|8, 16, 24, 32, 40, 48 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807304|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test|Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2811873|NCT00438815|Primary|Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf||Duration of the study (2.5 years)|Intent-to-treat Efficacy (ITT-E) Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).|||attacks|||Number
2807305|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting|Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed|||Units on a scale||Standard Error|Least Squares Mean
2807306|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test|Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, up to 7 days PS, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.|||Units on a scale||Standard Error|Least Squares Mean
2807307|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Sitting|Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.|||Units on a scale||Standard Error|Least Squares Mean
2807308|NCT00468845|Primary|Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).~Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Day 2 (24 hours post surgery [PS])|Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS|||Units on a scale||Standard Error|Least Squares Mean
2807309|NCT00468819|Secondary|Number of Participants With Change in Diagnostic Confidence by Age Group|In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).|up to 1 hour after Gadobutrol injection|FAS|||Participants|||Number
2807310|NCT00468819|Secondary|Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)|In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807311|NCT00468819|Secondary|Post-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807312|NCT00468819|Secondary|Pre-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807313|NCT00468819|Secondary|Post-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807314|NCT00468819|Secondary|Pre-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807315|NCT00468819|Secondary|Post-Contrast Lesions by Location and by Age Group|Number of lesions on post-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807316|NCT00468819|Secondary|Pre-Contrast Lesions by Location and by Age Group|Number of lesions on pre-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS|||Lesions|||Number
2807317|NCT00468819|Secondary|Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group|In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS|||Participants|||Number
2807318|NCT00468819|Secondary|Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group|In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality).|Up to 1 hour after Gadobutrol injection|FAS|||Participants|||Number
2807319|NCT00468819|Secondary|Urinary Excretion of Gadolinium as Percent of Administered Dose|Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging.|up to 6 hours after Gadobutrol injection|Valid for urinary analysis|||percentage of administered dose||Full Range|Mean
2807320|NCT00468819|Primary|Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group|Mean residence time of Gadobutrol in plasma expressed in h.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||hours||Inter-Quartile Range|Median
2807322|NCT00468819|Primary|Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group|Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||µmol*h/L||Inter-Quartile Range|Median
2807323|NCT00468819|Primary|Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set|||L/kg||Inter-Quartile Range|Median
2807324|NCT00468819|Primary|Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state expressed in L after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set|||L||Inter-Quartile Range|Median
2807325|NCT00468819|Primary|Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set|||L/h/kg||Inter-Quartile Range|Median
2807326|NCT00468819|Primary|Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.|From injection of Gadobutrol up to 8 hours after injection.|Final pharmacokinetics (PK) analysis set|||L/h||Inter-Quartile Range|Median
2807327|NCT00468728|Secondary|Global Cure|Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.|End of Study|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.|||Percentage of Participants|||Number
2807328|NCT00468728|Secondary|Recurrence|Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The analysis population is mITT, for subjects who met the primary endpoint of cure, was analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.|||Percentage of Participants|||Number
2807329|NCT00468728|Primary|Cure Rate at End of Therapy|Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2807330|NCT00468676|Primary|Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months|"Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 months and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||percent glycated hemoglobin||Standard Deviation|Mean
2807331|NCT00468676|Primary|LDL Cholesterol at Baseline and 12 Months|"LDL Cholesterol was measured at Baseline and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||mg/dL||Standard Deviation|Mean
2807332|NCT00468676|Primary|Systolic Blood Pressure at Baseline, 6 Months and 12 Months|"Systolic Blood Pressure was measured at Baseline, 6 months and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||mmHg||Standard Deviation|Mean
2807333|NCT00468676|Primary|Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months|"SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||scores on a scale||Standard Deviation|Mean
2807334|NCT00468676|Secondary|Health Care Costs|Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs|Cumulative outpatient costs over 24 months||||US dollars||Standard Deviation|Least Squares Mean
2807335|NCT00468676|Secondary|Functional Impairment|"Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is not at all and 10 is extremely. This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10."|Measured at Months 6, 12 months||||units on a scale||Standard Deviation|Mean
2807388|NCT00468559|Secondary|Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)|Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)||||Percentage of participants|||Number
2807336|NCT00468676|Primary|Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c|A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.|Baseline to 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes|||unitless||95% Confidence Interval|Number
2807337|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807338|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807339|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
2807340|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
2807341|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807342|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807343|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807344|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||Per-patient percentage||Standard Deviation|Mean
2807345|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807346|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
2807347|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2|"Mean change: mean change at each visit minus mean at Week 2. Percent of Yes responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)"|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807348|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline|"Mean change: mean change at each visit minus mean at baseline. Percent of Yes responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)"|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807349|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2|"Mean change: mean change at each visit minus mean at Week 2. Percent of Yes responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [Were you satisfied with this sexual encounter?] = Yes) / (number of occasions where SEP Question 5 was answered Yes or No)"|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807350|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline|"Mean change: mean change at each visit minus mean at baseline. Percent of Yes responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [Were you satisfied with this sexual encounter?] = Yes) / (number of occasions where SEP Question 5 was answered Yes or No)"|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
2807351|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2|"Mean change: mean change at each visit minus mean at Week 2. Percent of Yes responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [Were you satisfied with the hardness of your erection?] = Yes) / (number of occasions where SEP Question 4 was answered Yes or No)."|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807477|NCT00468169|Primary|Progression Free Survival (PFS)|Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|1 years||||Probability (%)||95% Confidence Interval|Number
2807352|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline|"Mean change: mean change at each visit minus mean at baseline. Percent of Yes responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [Were you satisfied with the hardness of your erection?] = Yes) / (number of occasions where SEP Question 4 was answered Yes or No)."|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807353|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2|"Mean change: mean change at each visit minus mean at Week 2. Percent of Yes responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)"|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807354|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline|"Mean change: mean change at each visit minus mean at baseline. Percent of Yes responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)"|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||per-patient percentage||Standard Deviation|Mean
2807355|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2|"Mean change: mean change at each visit minus mean at Week 2. Percent of Yes responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [Were you able to insert your penis into your partner's vagina?] = Yes) / (number of occasions where SEP Question 2 was answered Yes or No)."|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807356|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline|"Mean change: mean change at each visit minus mean at baseline. Percent of Yes responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [Were you able to insert your penis into your partner's vagina?] = Yes) / (number of occasions where SEP Question 2 was answered Yes or No)."|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807357|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2|"Mean change: mean change at each visit minus mean at Week 2. Percent of Yes responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)"|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807358|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline|"Mean change: mean change at each visit minus mean at baseline. Percent of Yes responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)"|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||per-patient percentage||Standard Deviation|Mean
2807359|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2815888|NCT00412360|Secondary|Percentage of Participants With Treatment-related Mortality|Treatment related mortality is defined as death without relapse of the primary disease.|1 year post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
2807360|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807361|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807362|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807363|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807364|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807365|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 4 and Week 6||||score on scale||Standard Deviation|Mean
2807366|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807367|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807368|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807820|NCT00466661|Secondary|Percent Carbohydrate-deficient Transferrin|Measured level of validated serum alcohol biomarker|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||"percent CDT"||Standard Deviation|Mean
2807369|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807370|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807371|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807372|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807373|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807374|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807375|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2|||score on scale||Standard Deviation|Mean
2807376|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2|||score on a scale||Standard Deviation|Mean
2807389|NCT00468559|Secondary|Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).|"The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient's GERD-related symptoms over the last 7 days as:~None Mild Moderate Severe"|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)||||Participants|||Number
2807377|NCT00468650|Primary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 6 LOCF|Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.|||score on scale||Standard Deviation|Mean
2807378|NCT00468585|Primary|Overall Objective Response|This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.|2 years||||participants|||Number
2807379|NCT00468559|Secondary|Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|83 patients were analyzed at the screening timepoint, 83 patients were analyzed at week 1 and 78 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
2807380|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
2807381|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
2807382|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.|||Units on a scale||Standard Deviation|Mean
2807383|NCT00468559|Secondary|Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)|Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.|Open-label treatment period (2 weeks)|95 patients received open-label esomeprazole during the open-label phase.|||Participants|||Number
2807384|NCT00468559|Secondary|Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
2807385|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
2807386|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
2807387|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained||||Units on a scale||Standard Deviation|Mean
2807859|NCT00466167|Secondary|Change From Baseline in UPDRS IV Score After 18 Weeks|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807390|NCT00468559|Secondary|Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|Reporting cumulative discontinuations. Results for the analysis of the secondary variable, time to discontinuation due to any cause, were identical to that found for the primary variable, time to discontinuation due to symptom.|||Participants|||Number
2807391|NCT00468559|Primary|Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.|Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|reporting cumulative discontinuations|||Participants|||Number
2807392|NCT00468546|Secondary|Percentage of Participants Without Erosive Progression|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage and negative change score indicates improvement.|Up to Week 104|ITT population included all randomized participants who received any part of an infusion of study medication. Participants with available data at the time of evaluation were analyzed.|||percentage of participants|||Number
2807393|NCT00468546|Secondary|Mean Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score, Genant-modified Sharp Total Score, and Erosion Score|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290. For all the three radiograph assessment, the minimum score is 0. A higher score indicates more damage and a negative change score indicates improvement. The change in score is to be calculated as: Change from Baseline = difference between the score at Weeks 24, 56, or 104 and the score at Baseline.|From Baseline (Day 1) to Weeks (W) 24, 56, and 104|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||units on a scale||Standard Deviation|Mean
2807394|NCT00468546|Secondary|Number of Participants With Change From Baseline in the Mental Component Scores of SF-36|The SF-36 determined participants' overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on mental component were summed and averaged (range = 0 [worst]-100 [best]); increase from baseline indicated improvement. If participants' had shown change from baseline in mental health score >6.33, it was considered as improved; scores between -6.33 to 6.33 was considered unchanged, and score <-6.33 was considered as worsened. Change from Baseline = difference between the mental component score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.|||participants|||Number
2807395|NCT00468546|Secondary|Number of Participants With Categorical Change From Baseline in the Physical Component Scores of SF-36|The SF-36 determined participants' overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on physical component were summed and averaged (range 0 [worst] to 100 [best]); If participants' had shown change from baseline in physical health component score >5.42, it was considered as improved; score between -5.42 to 5.42 was considered as unchanged, and score < -5.42 was considered as worsened. Change from Baseline = difference between the score of physical component at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.|||participants|||Number
2807396|NCT00468546|Secondary|Mean Change From Baseline of Short Form 36 Total Scores at Week 24|The Short Form (SF)-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Transforming and standardizing these domains leads to the calculation of the physical component summary and mental component summary measures. Scores on each item were summed and averaged (range 0 [worst] to 100 [best]); increase in score from baseline indicated improvement. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.|||units on a scale||Standard Deviation|Mean
2807458|NCT00468286|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|1 year||||participants|||Number
2807397|NCT00468546|Secondary|Percentage Change From Baseline in the ACR Core Set (SJC, TJC, Patient's and Physician's Global Assessments, Health Assessment Questionnaire, Pain, C-Reactive Protein, and Erythrocyte Sedimentation Rate) Score|Percentage change in the scores of the following parameters of ACR core set relative to respective baseline scores in both study arms was analyzed : SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS [0 = no disease activity to 100 = maximum disease activity]), HAQ (based on HAQ disability index [HAQDI]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain), CRP concentration, and ESR.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||percent change||Standard Deviation|Mean
2807398|NCT00468546|Secondary|Number of Participants With Good, Moderate, or no European League Against Rheumatism Responses at Week 24|European League Against Rheumatism (EULAR) response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. At a given visit, participants with a DAS28 score of < 3.2 are considered good responders if the change from baseline in their DAS28 score is >1.2. Participants with a DAS28 score >= 3.2 to 5.1 are considered moderate responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6. Participants with DAS28 score >5.1 are considered non-responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
2807399|NCT00468546|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission at Week 24|The DAS28 is an evaluation index of RA. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC- 28 joints, 2. SJC- 28 joints, 3. ESR or CRP measurement, 4. Participant's judgement on his own overall health status (GH) expressed by a visual analogue scale VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10. A participant was categorized as having low disease activity, if participant's DAS28 score was <= 3.2, and was categorized as having clinical remission if participant's DAS28 score was < 2.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||percentage of participants|||Number
2807400|NCT00468546|Secondary|Mean Change From Baseline in Disease Activity Score of 28 Joints at Week 24|The disease activity score (DAS28) is an evaluation index of rheumatoid arthritis. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC-28 joints, 2. SJC -28 joints, 3. ESR or CRP measurement, 4. Participant's judgement on his own overall health (global health [GH]) status expressed by a VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||units on a scale||Standard Deviation|Mean
2807401|NCT00468546|Secondary|Number of Participants With ACR 70 Response at Week 24|ACR 70 response is defined as a >= 70% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
2807402|NCT00468546|Secondary|Number of Participants With an ACR 50 Response at Week 24|ACR 50 response is defined as a >= 50% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
2807416|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807403|NCT00468546|Primary|Number of Participants With American College of Rheumatology 20 Response at Week 24|American College of Rheumatology (ACR) 20 response is defined as >= 20% improvement (reduction) in score compared with baseline for both tender joint count (TJC)-68 joints and swollen joint count (SJC)-66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) ranging from score 0 (no pain) to 100 (unbearable pain); Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging score 0 (no disease activity) to 100 (maximum disease activity); Health Assessment Questionnaire (HAQ):8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do) for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|Intent to treat (ITT) population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.|||participants|||Number
2807404|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807405|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807406|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807407|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807408|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807409|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807410|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807411|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807412|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807413|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807414|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807415|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807417|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807418|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807419|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807420|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807421|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807422|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807423|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807424|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807425|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807426|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807427|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807428|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807429|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807430|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807456|NCT00468299|Secondary|Complete Abortion at One Week|Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound|3 weeks|Per protocol|||participants|||Number
2807431|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807432|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 24|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
2807433|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 20|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
2807434|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 16|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
2807435|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 12|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
2807436|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 8|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||µg/L||Standard Deviation|Mean
2807437|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 4|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||µg/L||Standard Deviation|Mean
2807438|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807439|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807440|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807441|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||µg/L||Standard Deviation|Mean
2807442|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807443|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807444|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807457|NCT00468299|Primary|Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.||24-48 hrs||||participants|||Number
2807445|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807446|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||Standard Deviation|Mean
2807447|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24|||nmol/L||Standard Deviation|Mean
2807448|NCT00468481|Secondary|Mean Neural Tube Defect (NTD) Risk Reduction at Week 24|The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline|Baseline and week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||per 1000 birth||Standard Deviation|Mean
2807449|NCT00468481|Primary|Plasma Folate Level at 24 Weeks|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||95% Confidence Interval|Least Squares Mean
2807450|NCT00468481|Primary|Red Blood Cell (RBC) Folate Level at 24 Weeks|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.|||nmol/L||95% Confidence Interval|Least Squares Mean
2807451|NCT00468312|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||liters/minute||Standard Deviation|Least Squares Mean
2807452|NCT00468312|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.|||Score on a scale||Standard Deviation|Least Squares Mean
2807453|NCT00468312|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||Score on a scale||Standard Deviation|Least Squares Mean
2807454|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||Score on a scale||Standard Deviation|Least Squares Mean
2807455|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||Score on a scale||Standard Deviation|Least Squares Mean
2807459|NCT00468286|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline up to 1 year||||participants|||Number
2807460|NCT00468286|Secondary|Serum Levels of Luteinizing Hormone (LH) Over Time||1 year||||IU/L||Full Range|Median
2807461|NCT00468286|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) Over Time||1 year||||IU/L||Full Range|Median
2807462|NCT00468286|Secondary|Serum Levels of PSA Over Time||1 year||||ng/mL||Full Range|Median
2807463|NCT00468286|Secondary|Probability of no PSA Failure|Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).|1 year||||percentage of participants||95% Confidence Interval|Mean
2807464|NCT00468286|Secondary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.|1 year||||percentage of participants||95% Confidence Interval|Mean
2807465|NCT00468286|Secondary|Serum Levels of Testosterone Over Time||1 year||||ng/mL||Full Range|Median
2807466|NCT00468286|Primary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.|1 year||||percentage of participants||95% Confidence Interval|Mean
2807467|NCT00468208|Secondary|Disease Relapse|"Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission.~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
2807468|NCT00468208|Secondary|Meeting Common Closing|The number of subjects that reached the common closing date.|Number assessed at the time of common closing, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
2807469|NCT00468208|Secondary|Disease Improvement|"Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG).~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
2807470|NCT00468208|Secondary|Disease Remission|"Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0.~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination,up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
2807471|NCT00468208|Primary|Safety of Abatacept - Number of Participants With Adverse Events|"This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following:~Infection~Infusion reactions~Cytopenias~Transaminase elevation~Skin reactions~GI side effects~Malignancy~All adverse events were reportable for this study."|Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.|||participants|||Number
2807472|NCT00468169|Secondary|Residual Lymph Node Disease|Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.|Up to 10 weeks||||Participants|||Count of Participants
2807473|NCT00468169|Secondary|Objective Response Rate to CRT|Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.|From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks||||Participants|||Count of Participants
2807474|NCT00468169|Secondary|Objective Response Rate to Induction|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Post-Induction (8 weeks)||||Participants|||Count of Participants
2807475|NCT00468169|Secondary|Overall Survival (OS)|Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.|2 years||||Probability (%)||95% Confidence Interval|Number
2807476|NCT00468169|Primary|Progression Free Survival (PFS)|Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||Probability (%)||95% Confidence Interval|Number
2807478|NCT00468143|Secondary|Self Report|Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage).|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of participants adherent|||Number
2807479|NCT00468143|Secondary|Pill Count|Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed.|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of pills consumed|||Number
2807480|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Time Adherence|Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of participants adherent|||Number
2807481|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Regimen Adherence|Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)||||percentage of participants adherent|||Number
2807482|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Dosage Adherence|Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|These is the total of participants who completed the study.|||percentage of participants adherent|||Number
2807483|NCT00468104|Secondary|Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy|patients were followed for 6 weeks and resolution of sepsis was documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
2807484|NCT00468104|Secondary|Number of Participants With Shortness of Breath That Responded to Therapy|patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
2807485|NCT00468104|Secondary|Number of Participants With Pleural Effusion/Empyema That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
2807486|NCT00468104|Secondary|Number of Participants With Pneumonia That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed|||participants|||Number
2807487|NCT00468104|Primary|No Surgical Intervention|CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.|patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months|intention to treat|||participants|||Number
2807488|NCT00468052|Secondary|Participants Requiring Morphine Rescue in PACU||arrival in PACU to 2 hours postoperatively||||participants|||Number
2807489|NCT00468052|Secondary|Number of Participants With SpO2 < or Equal to 95%||on arrival to PACU and 2 hours postoperatively||||participants|||Number
2807490|NCT00468052|Secondary|Time to Extubation|defined as time from end of surgery to tracheal extubation|at end of surgical procedure|per protocol|||minutes||Standard Deviation|Mean
2807491|NCT00468052|Secondary|Time to Awaken|defined as spontaneous eye opening or on command|at end of surgery|per protocol|||minutes||Standard Deviation|Mean
2807492|NCT00468052|Secondary|Hemodynamic Stability|Participants whose heart rate per minute was below 60 intraoperatively. Participants whose systolic blood pressure dremonstrated < 30% decrease from baseline and sustained for 5 minutes received rescue as defined by the protocol.|intraoperatively||||participants|||Number
2807493|NCT00468052|Primary|Duration of Agitation|Cole EA scale 1=calm , 5=unconsolable|on arrival to PACU and for 2 hours postoperatively||||minutes||Standard Deviation|Mean
2807494|NCT00468052|Primary|Emergence Agitation and Pain|"emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated .~Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain"|On arrival to PACU and 2 hours postoperatively|per protocol, OPS, PAED and Cole scale are expressed as median values of the maximum score|||units on a scale||Full Range|Median
2807507|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of complete doses||Standard Deviation|Mean
2807495|NCT00467961|Primary|To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression.|Patients will receive a selectively photodepleted lymphocyte product which will be delivered together with the T cell depleted stem cell product on the day of transplantation. Subjects will receive a conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34-selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized. To determine if selective T cell depletion using the photodepletion procedure can substantially reduce the number of severe acute GVHD (grade III/IV) after transplantation followed by low-dose or no immunosuppression.|Day 90|The study accrued 31 transplant recipents and 30 donors. Of the 31 transplant recipients, there were 24 evaluable recipients. Seven of the 24 recipients did not receive transplantation.|||participants|||Number
2807496|NCT00467896|Primary|Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)|Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of full doses administered||Standard Deviation|Mean
2807497|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)|HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population|||beats per minute||Standard Deviation|Mean
2807498|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-6 (Period I)|HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population|||beats per minute||Standard Deviation|Mean
2807499|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
2807500|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)|DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
2807501|NCT00467896|Secondary|Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
2807502|NCT00467896|Secondary|Systolic Blood Pressure - Iloprost PD-6 (Period I)|SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population|||mmHg||Standard Deviation|Mean
2807503|NCT00467896|Secondary|Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of daily doses||Standard Deviation|Mean
2807504|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-15 (Period II)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of full doses administered||Standard Deviation|Mean
2807505|NCT00467896|Secondary|Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of daily doses||Standard Deviation|Mean
2807506|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of complete doses||Standard Deviation|Mean
2807508|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-15 (Period II)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||minutes||Standard Deviation|Mean
2807509|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-6 (Period I)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||minutes||Standard Deviation|Mean
2807510|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-15 (Period II)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||inhalations/day||Standard Deviation|Mean
2807511|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-6 (Period I)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||inhalations/day||Standard Deviation|Mean
2807512|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-6 (Period I)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.|||percentage of full doses administered||Standard Deviation|Mean
2807513|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part C2||Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
2807514|NCT00467870|Secondary|Trough Assessments of Serum Total Testosterone Concentrations in Part C2||Screening; day 0; and weeks 4, 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
2807515|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2|Serum total testosterone concentrations outside the normal range are categorized as <300 ng/dL (below lower limit of normal range) and >1000 ng/dL (above upper limit of normal range)|Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||percentage of participants|||Number
2807516|NCT00467870|Secondary|Serum Total Testosterone Concentrations in Part C2||Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
2807517|NCT00467870|Secondary|Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2||Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||pg/mL||Standard Deviation|Mean
2807518|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2||Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||percentage of participants|||Number
2807519|NCT00467870|Secondary|Change in Weight From Baseline to Week 24 in Part C||Baseline, Week 24|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis|||kg||Standard Deviation|Mean
2807520|NCT00467870|Secondary|Change in Body Mass Index From Baseline to Week 24 in Part C|Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2)|Baseline, Week 24|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis|||kg/m2||Standard Deviation|Mean
2807591|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807521|NCT00467870|Secondary|Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C|M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied).|Day 21 post injection at week 14|Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807522|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807523|NCT00467870|Secondary|Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C|Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807524|NCT00467870|Secondary|Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis|||days||Standard Deviation|Mean
2807525|NCT00467870|Secondary|Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807526|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C||Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807527|NCT00467870|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C|Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807528|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807529|NCT00467870|Secondary|Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C|Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807530|NCT00467870|Secondary|Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis|||days||Standard Deviation|Mean
2807531|NCT00467870|Secondary|Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807532|NCT00467870|Secondary|Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2811929|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6|"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired"|58 weeks|Patients of ITT population with data at V6|||participants|||Number
2807533|NCT00467870|Secondary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C|Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807534|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part B||Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80|Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (2 from B-TU 750 mg and 12 from B-TU 1000 mg)|||ng/dL||Standard Deviation|Mean
2807535|NCT00467870|Secondary|Serum Total Testosterone Maximum Concentration in Part A||Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120|Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (20 from A-TU 750 mg and 11 from A-TU 1000 mg)|||ng/dL||Standard Deviation|Mean
2807536|NCT00467870|Primary|Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2|Serum total testosterone Ctrough derived from the 2nd injection IPK interval|Day 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
2807537|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2|Serum total testosterone Cmax derived from the 2nd injection IPK interval|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
2807538|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2|Serum total testosterone Cavg derived from the 2nd injection IPK interval|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||ng/dL||Standard Deviation|Mean
2807539|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2|Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.|Days 0, 4, 7, 11, 14, and 70 post injection at week 4|Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)|||percentage of participants|||Number
2807540|NCT00467870|Primary|Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C|Serum total testosterone Ctrough derived from the 4th injection IPK interval|Day 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
2807541|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C|Serum total testosterone Cmax derived from the 4th injection IPK interval|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
2807542|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C|Serum total testosterone Cavg derived from the 4th injection IPK interval|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
2807543|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C|Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval.|Days 0, 4, 7, 11, 42, and 70 post injection at week 24|Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807544|NCT00467870|Primary|Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C|Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval|Day 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
2807545|NCT00467870|Primary|Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C|Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
2807546|NCT00467870|Primary|Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C|Serum total testosterone Cavg derived from the 3rd injection IPK interval|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||ng/dL||Standard Deviation|Mean
2811960|NCT00438191|Secondary|Treatment Satisfaction|Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction|8 weeks||||units on a scale||Standard Deviation|Mean
2807547|NCT00467870|Primary|Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C|Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval.|Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14|Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)|||percentage of participants||95% Confidence Interval|Number
2807548|NCT00467857|Secondary|Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)|Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site|30 days|Subset of Intention to treat participants with alcohol use, tobacco use, or obesity|||Participants|||Number
2807549|NCT00467857|Secondary|Number of Patients With SSI at the Sternal Site and/or Graft Site|Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period|30 days|Intention to treat|||Participants|||Number
2807550|NCT00467857|Secondary|Post-incision Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807551|NCT00467857|Secondary|Post-incision Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807552|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807553|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||isolates||Standard Deviation|Mean
2807554|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807555|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||isolates||Standard Deviation|Mean
2807556|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol|||isolates||Standard Deviation|Mean
2807557|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807558|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807559|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807560|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||log CFU/mL||Standard Deviation|Mean
2807561|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol|||isolates||Standard Deviation|Mean
2807562|NCT00467844|Secondary|To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.|Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].|Four Months|The subjects were in the MITT population (had a post baseline DEXA) and had a month 4 stair climb assessment (observed cases).|||watts||Full Range|Median
2807563|NCT00467844|Primary|The Efficacy of GTx-024 on Total Body Lean Mass.|Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.|Baseline to Four Months|The number of participants were those subjects in the modified intent-to-treat population (defined as subjects with at least one post baseline DEXA for LBM) who had baseline and 4 month DEXA results for LBM (observed cases).|||kg||Full Range|Median
2807564|NCT00467831|Primary|Survival at 2 Years|The number of subjects surviving after 24 months on study.|24 months||||participants|||Number
2807565|NCT00467779|Secondary|Stage III: AUC0-inf of Midazolam|AUC0-inf is the AUC from time 0 to infinity and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807566|NCT00467779|Secondary|Stage III: AUC0-24 of Midazolam|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was calculated both in the presence (Cycle 1 Day 15) and absence (CXycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807567|NCT00467779|Secondary|Stage III: Cmax of Midazolam|Cmax is the maximum observed plasma concentration and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Geometric Mean
2807568|NCT00467779|Secondary|Stage III: AUC 0-inf of Dextromethorphan|AUC0-inf is AUC from time 0 to infinity and was calculated both in presence Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807569|NCT00467779|Secondary|Stage III: AUC 0-24 of Dextromethorphan|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was determined both in presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807570|NCT00467779|Secondary|Stage III: Cmax of Dextromethorphan|Cmax is defined as maximum observed plasma concentration and was determined both in the presence (Cycle 1 Day 15) and absence of cobimetinib (Cycle 1 Day 1).|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n=number of participants analyzed for specified category.|||ng/mL||Standard Deviation|Geometric Mean
2807571|NCT00467779|Secondary|Stage 2A: Cmax of Cobimetinib at Steady State|Cmax is the maximum plasma concentration achieved following the Day 20 dose in Stage 2A.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Analysis population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Geometric Mean
2807572|NCT00467779|Secondary|Stage 2A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2A in steady state.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807573|NCT00467779|Secondary|Stage 2A: Half-Life of Cobimetinib at Steady State||Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807574|NCT00467779|Secondary|Stage 2A: Apparent Clearance of Cobimetinib at Steady State|Apparent clearance is the plasma clearance of absorbed drug.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Standard Deviation|Mean
2807575|NCT00467779|Secondary|Stage 2A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio AUC0-24 is ratio of AUC on Day 20: Day 1.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Mean
2807576|NCT00467779|Secondary|Stage 2A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
2807577|NCT00467779|Secondary|Stage 2:Half-Life of Cobimetinib at Steady State|T1/2 half-life of cobimetinib measured over the terminal phase by noncompartmental analysis.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807578|NCT00467779|Secondary|Stage 2: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population|||L/hr||Standard Deviation|Mean
2807579|NCT00467779|Secondary|Stage 2: Accumulation Ratio of Cobimetinib at Steady State|Accumulation ratio is AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Geometric Mean
2807580|NCT00467779|Secondary|Stage 2: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807581|NCT00467779|Secondary|Stage 2: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807582|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only; Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807583|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 2 on Day 1.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807584|NCT00467779|Secondary|Stage 2:AUC 0-24 of Cobimetinib at Cycle 1 Day 1|The area under the AUC0-24 on Day 1 in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Geometric Mean
2807585|NCT00467779|Secondary|Stage 2: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 2 and was measured in ng/mL.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Geometric Mean
2807586|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1A and was measured in steady state as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Mean
2807587|NCT00467779|Secondary|Stage 1A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng*hr/mL/mg||Standard Deviation|Mean
2807588|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1A was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
2807589|NCT00467779|Secondary|Stage 1A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Mean
2807590|NCT00467779|Secondary|Stage 1A: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number pf participants analyzed = participants who were evaluable for this outcome.|||L/hr||Standard Deviation|Mean
2811961|NCT00438191|Secondary|Grip Strength|Grip strength is measured as a percentage of the non-affected or least affected side.|8 weeks||||percentage of non-affected hand||Standard Deviation|Mean
2807592|NCT00467779|Secondary|Stage 1A: t1/2 of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807593|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Cycle 1 Day 1|AUC0-24 for stage 1A was calculated on Day 1 with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.|||h*ng/mL||Standard Deviation|Mean
2807594|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on on Day 1 in Stage 1A and was measured as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.|||ng/mL||Standard Deviation|Mean
2807595|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 1A at Day 1.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.|||hours||Full Range|Median
2807596|NCT00467779|Secondary|Stage 1: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1 and was measured at steady state in ng/mL.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Mean
2807597|NCT00467779|Secondary|Stage 1: Half-Life (t1/2) of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807598|NCT00467779|Secondary|Stage 1: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/hr)||Standard Deviation|Mean
2807599|NCT00467779|Secondary|Stage 1: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Standard Deviation|Mean
2807600|NCT00467779|Secondary|Stage 1: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety Population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||ng*hr/mL/mg||Standard Deviation|Mean
2807601|NCT00467779|Secondary|Stage 1: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
2807602|NCT00467779|Secondary|Stage 1: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1 in steady state. Steady state was reached when overall intake of cobimetinib was in dynamic equilibrium with its elimination.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2807603|NCT00467779|Primary|Stage 1: Time to Maximum Concentration (Tmax) of Cobimetinib at Day 1, Cycle 1|Tmax is defined as the time to reach Cmax during stage 1 at Day 1 Cycle 1.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.|||hours||Full Range|Median
2807604|NCT00467779|Primary|Stage 1: Area Under the Plasma Cobimetinib Concentration Curve From Time 0 to 24 Hours (AUC 0-24) Day 1, Cycle 1|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samples. AUC is measured as hours times nanograms per milliliter (h*ng/mL).|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.|||h*ng/mL||Standard Deviation|Geometric Mean
2807605|NCT00467779|Primary|Stage 1: Maximum Observed Concentration (Cmax) of Cobimetinib at Day 1, Cycle 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on Day 1, Cycle 1 in Stage 1 and was measured as nanograms per milliliter (ng/mL).|Stage 1: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.|||ng/mL||Standard Deviation|Geometric Mean
2807606|NCT00467779|Primary|Stage 1A: MTD of Cobimetinib in 14/14 Schedule|"AEs were graded according to NCI-CTCAE v3.0. A DLT was the basis for determining MTD in Stage 1A participants. The participants of Stage 1A are dose-escalation cohorts, starting at the MTD of the 21/7 schedule, were treated on a 14/14 schedule to determine the MTD. A DLT was defined as either of the following occurring during the Study Treatment Period:~Occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants to risk of irreversible medical harm; Nonhematologic toxicity: Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment; Hematologic toxicity: Grade 4 thrombocytopenia. Grade 4 neutropenia of more than 4 days' duration; Grade 4 neutropenia of any duration with fever or documented infection. AEs (Grade 3 or higher) for which a clinical cause unrelated to cobimetinib was evident was not considered DLTs."|Stage 1A: Days 1 to 28 of Cycle 1|Safety population; Stage 1A participants only.|||mg|||Number
2807607|NCT00467779|Primary|Stage 1: Maximum Tolerated Dose (MTD) of Cobimetinib in 21/7 Schedule|"AEs were graded according to the NCI-CTCAE v3.0. A DLT was determined from clinical findings during the Study Treatment Period (Cycle 1, Days 1). MTD was defined as the dose at which no DLTs were observed. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity~Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity~Grade 4 thrombocytopenia~Grade 4 neutropenia of greater than or equal to (≥) 4 days' duration~Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1: Days 1 to 28 of Cycle 1|Safety population; Stage 1 participants only.|||milligrams (mg)|||Number
2807608|NCT00467779|Primary|Stage 1 and 1A: Number of Participants With Dose Limiting Toxicities (DLTs)|"Adverse events (AE) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the cohort review committee (CRC), was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity~Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity~Grade 4 thrombocytopenia~Grade 4 neutropenia of greater than or equal to (≥) 4 days' duration~Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1 and 1A: Days 1 to 28 of Cycle 1|Safety population; Stages 1 and 1A participants only.|||participants|||Number
2807609|NCT00467753|Primary|Autism Diagnostic Observation Schedule||Evaluated during Baseline and Termination|||||||
2807610|NCT00467753|Primary|Clinical Global Impression Improvement Scale||Once a week|||||||
2807611|NCT00467753|Primary|Aberrant Behavior Checklist||Bi weekly|||||||
2807612|NCT00467753|Primary|Vineland Adaptive Behavior Scales||Evaluated during Baseline and Termination|||||||
2807613|NCT00467740|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and 29 days|Treated Set|||mmol/L||Inter-Quartile Range|Geometric Mean
2807614|NCT00467740|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set|||participants|||Number
2807615|NCT00467740|Secondary|Total Score in Asthma Control Questionnaire After 4 Weeks|Adequacy of asthma control was assessed using a scale of: 0=totally controlled, to 6=Severely uncontrolled.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||units on a scale||Standard Error|Least Squares Mean
2807616|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||hours||Full Range|Median
2807617|NCT00467740|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2807618|NCT00467740|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=24 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2807619|NCT00467740|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=6 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2807620|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2807621|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||hours||Full Range|Median
2807622|NCT00467740|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2807623|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2807624|NCT00467740|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (prn salbutamol [albuterol]) as assessed by the e-Diary (e-Diary incorporated in AM2+).|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Number of Puffs||Standard Error|Least Squares Mean
2807625|NCT00467740|Secondary|PEFR Variability After 4 Weeks|PEFR variability represents the absolute difference between the highest morning PEFR value and the highest evening PEFR value of 1 day, divided by the arithmetic mean of these 2 PEFR values and expressed as a percent, weekly means.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||percentage of PEFR||Standard Error|Least Squares Mean
2807626|NCT00467740|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Response was defined as change from baseline. Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
2807627|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 6-12 h (AUC 6-12h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior to dose on first day of randomized treatment (baseline) and 1h, 3h, 6h, 9h, 12h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807628|NCT00467740|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807629|NCT00467740|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807630|NCT00467740|Secondary|Peak FVC (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807631|NCT00467740|Secondary|Peak FVC (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807632|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807633|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807634|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807635|NCT00467740|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807636|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807637|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807638|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807639|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807640|NCT00467740|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807701|NCT00467285|Primary|Changes in BMD at Femoral Neck|% changes in BMD ( BMD at Lumbar spine, femoral neck and 0.33 radius) and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on Pioglitazone|6 months|28 subjects on pioglitazone and 64 subjects not on pioglitazone|||percentage of change in BMD||Standard Deviation|Mean
2807641|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807642|NCT00467740|Secondary|Trough FVC Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807643|NCT00467740|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807644|NCT00467740|Secondary|Trough FVC Response After 1 Week|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807645|NCT00467740|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807646|NCT00467740|Secondary|Trough FEV1 Response After 1 Week|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807647|NCT00467740|Secondary|Weekly Mean Pre-dose Morning PEFR After 4 Weeks|Response was defined as change from baseline. Baseline peak expiratory flow response (PEFR) was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
2807648|NCT00467740|Primary|Trough FEV1 Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2807649|NCT00467649|Other Pre-specified|Hypoglycemia Adverse Events|"MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.~MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).~SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention."|36 weeks||||participants|||Number
2807650|NCT00467649|Secondary|Phase 2: Change in Body Weight at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat|||kg||Standard Error|Mean
2807651|NCT00467649|Secondary|Phase 2: Change in HbA1c at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat|||Percent||Standard Error|Mean
2807652|NCT00467649|Secondary|Fasting Serum Lipids Change From Baseline to Week 24||Baseline, week 24|Phase 1 Intent-to-Treat|||mg/dL||Standard Error|Mean
2807653|NCT00467649|Secondary|Change in Fasting Plasma Glucose From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat|||mg/dL||Standard Error|Mean
2807654|NCT00467649|Secondary|Change in Waist Circumference From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||cm||Standard Error|Least Squares Mean
2807655|NCT00467649|Secondary|Change in Body Weight From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||kg||Standard Error|Least Squares Mean
2807656|NCT00467649|Secondary|Change in HbA1c From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||Percent||Standard Error|Least Squares Mean
2807657|NCT00467649|Secondary|Percentage of Patients With a Severe Hypoglycemia Adverse Event|This is a component of the primary endpoint.|24 Weeks|Phase 1 Intent-to-Treat|||Percent|||Number
2807658|NCT00467649|Secondary|Percentage of Patients With no Weight Gain at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat|||Percent|||Number
2807659|NCT00467649|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat|||Percent|||Number
2807660|NCT00467649|Primary|The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia|A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.|24 Weeks|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.|||Percent|||Number
2807661|NCT00467610|Secondary|Hematological Improvement Rate at Week 8 as Defined by the IWG 2000 Criteria for Response Assessment, 2000 Version||At 8 weeks from start of therapy||||participants|||Number
2807662|NCT00467610|Primary|Response Rate ( CR+PR) at Week 8, Based on the IWG Criteria for Response Assessment ( 2000 Version)|"Complete response(CR): <5% blasts in the bone marrow,with normal maturation of all cell lines, Hemoglobin >11 g/dL, neutrophils>1500/mm3 platelets>100,000/mm3.~Partial response (PR): >50% decrease in blasts, or less advanced IPSS than pretreatment value, same hematological parameters as in CR.~Stable disease (SD): No evidence of disease progression in bone marrow, stable peripheral blood counts failure: Increase in bone marrow blast percentage, progression to more advanced IPSS than pretreatment and worsening of cytopenias.~(Cheson, 2000)"|After 8 weeks of therapy with panhematin||||Participants|||Number
2807663|NCT00467610|Secondary|Number of Patients Demonstrating Hematological Improvement to Panhematin® at Week 4.|"Hematological improvement (HI)~Major:~HI-Erythroid:>2 g/dL rise in hemoglobin, or transfusion independence HI-Neutrophil: Absolute increase of >500/mm3, or >100% increase HI-Platelet: Absolute increase of >30,000, or transfusion independence~Minor:~HI-Erythroid:1 to 2 g/dL increase in hemoglobin or 50% decrease in transfusion dependence.~HI-P: For patients with pretreatment platelet count < 100,000/mm3, ≥ 50% increase with a net increase > 10,000/mm3 but < 30,000/mm3.~HI-N: For patients with pretreatment ANC < 1500/mm3, ≥ 100% increase, but < 500/mm3 increase."|4 weeks after initiation of treatment with Panhematin||||participants|||Number
2807664|NCT00467610|Primary|Safety and Tolerability of Panhematin®.|Number of patients with no adverse events.|participants were followed during therapy with panhematin, and up to six months post completion of therapy, average of 8 months.||||participants|||Number
2807665|NCT00467597|Primary|Gaitmat Stance Measurements (AUC)|Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.|Every 1/2 hour during an 8 hour period.||||Root Mean Square of Velocity*Minutes||Standard Deviation|Mean
2807666|NCT00467584|Primary|Modified Fatigue Impact Scale Score|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always) were provided by the study subjects for the prior 4 week period. A total score was tallied from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, 8 weeks|62 patients were randomized; of these, 6 did not receive the intervention and an additional 4 discontinued without providing followup data. Therefore 52 were included in the analysis. The Wk 4 MFIS score was used if the subject withdrew prior to Wk 8. 1 subject each in the High Dose and Placebo groups provided MFIS data at Wk 4 but not Wk 8.|||units on a scale||Standard Deviation|Mean
2807667|NCT00467558|Primary|Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)|The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
2807668|NCT00467558|Secondary|Clinical Global Impression Scale - Severity|"The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = very much improved to 7 = very much worse. The CGI severity scale was used at each visit and ranges from 1 = not ill at all to 7 = among the most extremely ill."|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
2807669|NCT00467519|Primary|Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis|Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Pre-dose and 30 Days Post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
2820524|NCT00380250|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
2807670|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL.~Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.|||Percentage of Participants|||Number
2807671|NCT00467519|Other Pre-specified|Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination|Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2807672|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL~Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.|||Percentage of Participants|||Number
2807673|NCT00467519|Primary|Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL|"Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL.~Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.|||Percentage of Participants|||Number
2807674|NCT00467519|Primary|Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level|"Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL.~Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.|||Percentage of Participants|||Number
2807675|NCT00467389|Secondary|Cocaine Pharmacokinetics|Area-Under-the-Curve for Plasma Concentration|0 to 8 hours||||ng-hr/ml||Standard Error|Mean
2807676|NCT00467389|Secondary|Cocaine Subjective Effects|Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).|3 to 30 minutes||||mm||Standard Error|Mean
2807677|NCT00467389|Primary|Cocaine Safety in Subjects Receiving Donepezil|Patients evaluated for clinical and laboratory adverse events|Two weeks|All participants included|||Participants with an Adverse Event|||Number
2807678|NCT00467363|Secondary|Abruption|Partial or complete abruption (ie, premature separation of the placenta)|until delivery||||participants|||Number
2807679|NCT00467363|Secondary|Fetal Intolerance of Labor||until delivery|No data were collected for this Outcome Measure.||||||
2807680|NCT00467363|Secondary|Abnormal Fetal Testing||8 weeks|No data were collected for this Outcome Measure.||||||
2807681|NCT00467363|Secondary|Preterm Birth||until delivery||||infants|||Number
2807682|NCT00467363|Secondary|Small for Gestational Age Infant|birthweight|until delivery||||grams||Standard Deviation|Mean
2807683|NCT00467363|Secondary|Preeclampsia||until delivery||||participants|||Number
2807684|NCT00467363|Secondary|Molar Pregnancy||8 weeks||||pregnancy|||Number
2807685|NCT00467363|Secondary|Ectopic Pregnancy||within 6 weeks||||pregnancy|||Number
2807686|NCT00467363|Secondary|Stillbirth||40 weeks||||participants|||Number
2807687|NCT00467363|Secondary|Fetal Pregnancy Loss||until 40 weeks||||pregnancy|||Number
2807688|NCT00467363|Secondary|Pregnancy Losses Occurring Less Than 10 Weeks|Includes preembryonic and embryonic losses (exclusive of implantation failures)|less than 10-weeks||||pregnancy|||Number
2807689|NCT00467363|Secondary|Early Pregnancy Loss (EPL)|Implantation failures|8 weeks||||pregnancy|||Number
2807690|NCT00467363|Secondary|Clinically Recognized Pregnancy||8-weeks||||pregnancy|||Number
2807691|NCT00467363|Secondary|hCG Recognized Pregnancy||within 8-weeks of gestation||||pregnancy|||Number
2807692|NCT00467363|Primary|Live Birth|Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .|after delivery|Analyses were based on the intention-to-treat principle (excluding participants lost to follow-up).|||livebirths|||Number
2807693|NCT00467298|Secondary|Quality of Life|SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores.|6 months|These are not change scores.|||units on a scale||Standard Deviation|Mean
2807694|NCT00467298|Primary|Function Capability|6MWT-Six Minute Walk Test|6 months||||meters||Standard Deviation|Mean
2807695|NCT00467285|Primary|Changes in BMD 0.33 Radius|% change in BMD at 6 month follow up compared to baseline|6 months||||% change in BMD||Standard Deviation|Mean
2807696|NCT00467285|Primary|Changes in BMD AP Spine|% change in BMD at 6 month follow up compared to baseline|6 months||||% change in BMD||Standard Deviation|Mean
2807697|NCT00467285|Secondary|Changes in CTx at Follow up|% change in the levels of CTx at 6 months follow up compared to baseline|6 months||||% change||Standard Deviation|Mean
2807698|NCT00467285|Primary|Changes in BMD Total Hip|% change at 6 month follow up compared to baseline|6 months||||% change in BMD||Standard Deviation|Mean
2807699|NCT00467285|Secondary|Osteocalcin|% change at 6 month follow up compared to baseline|6 months||||% change||Standard Deviation|Mean
2807700|NCT00467285|Secondary|CTx|% Change in bone turnover markers at 6 month follow up compared to baseline|6 months||||pg/mL||Standard Deviation|Mean
2807702|NCT00467259|Secondary|Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.|||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
2807703|NCT00467259|Secondary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.|||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
2807704|NCT00467259|Primary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.|||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
2807705|NCT00467077|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 5 years.||||Months||95% Confidence Interval|Median
2807706|NCT00467077|Secondary|Progression-Free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression, up to 5 years.||||Months||95% Confidence Interval|Median
2807707|NCT00467077|Secondary|Number of Participants With Overall Response as Measured by RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR|After 2 cycles of treatment, up to 2 years.||||participants|||Number
2807708|NCT00467077|Primary|Six-month Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions|From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||percentage of participants||95% Confidence Interval|Number
2807709|NCT00467051|Secondary|The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.||Two cycles of chemotherapy; expected to be 42 days of treatment.|All eligible patients.|||Participants|||Count of Participants
2807710|NCT00467051|Primary|Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.|At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)||||participants|||Number
2807711|NCT00467038|Secondary|Group x Time Interaction Amygdala Activity|0 to 12 month difference scores in group x time interaction amygdala activity|Baseline and 12 months||||bold signal units||Standard Deviation|Mean
2807712|NCT00467038|Primary|Self-Report of Difficulties in Emotion Regulation (DERS)|"The present study examines DBT treatment effect on emotion regulation in unmedicated outpatients with BPD as measured by changes in the Difficulties in Emotion Regulation Scale. The DERS is a brief, 36-item, self-report questionnaire.~DERS total score ranges from 36- 180. Higher scores reflect higher difficulties in emotion regulation.~The measure yields a total score as well as scores on six scales derived through factor analysis:~1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity Responses are on a 5-point scale: 1=almost never, 2=sometimes, 3=about half the time, 4=most of the time, 5=almost always"|12 months|22 age- and gender-matched unmedicated BPD and HC participants (11 in each group).|||units on a scale||Standard Deviation|Mean
2807713|NCT00466960|Secondary|Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens|Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.|Up to 5 years||||Pearson correlation||95% Confidence Interval|Number
2807714|NCT00466960|Secondary|Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens|Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.|Up to 5 years||||Pearson correlation||95% Confidence Interval|Number
2807715|NCT00466960|Secondary|Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration|Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).|Up to 5 years||||% of CD45+PBMC||Inter-Quartile Range|Median
2807716|NCT00466960|Secondary|Correlation Between Circulating Monocytes and Time to Progression|Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).|Up to 5 years||||percentage of CD45+ in PBSC||Inter-Quartile Range|Median
2807717|NCT00466960|Primary|Response Rate|Number of patients achieving a complete or partial response.|Up to 5 years||||Participants|||Count of Participants
2807718|NCT00466960|Primary|Time to Progression|Median time to progression|Up to 5 years||||months||95% Confidence Interval|Median
2807821|NCT00466661|Secondary|Percent Heavy Drinking Days|Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females)|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||percentage of days drinking||Standard Deviation|Mean
2807719|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807720|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807721|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2807722|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2807723|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807724|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807725|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807726|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2811962|NCT00438191|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.|8 weeks||||units on a scale||Standard Deviation|Mean
2807727|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
2807728|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
2807729|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
2807730|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination,|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Titers||95% Confidence Interval|Geometric Mean
2807731|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807732|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807733|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807734|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807822|NCT00466661|Secondary|Percent Days Abstinent|Percentage of days in trial with no alcohol consumption|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||percentage of days in trial||Standard Deviation|Mean
2811963|NCT00438100|Secondary|Survival Rate||The follow up period will be two years after the last dose has been administered.|||||||
2807735|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807736|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807737|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807738|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||Subjects|||Number
2807739|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
2807740|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
2807741|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
2807769|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2811964|NCT00438100|Secondary|Time to Treatment Failure||The follow up period will be two years after the last dose has been administered.|||||||
2807742|NCT00466947|Secondary|Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.|||µg/mL||95% Confidence Interval|Geometric Mean
2807743|NCT00466947|Secondary|Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807744|NCT00466947|Secondary|Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807745|NCT00466947|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807746|NCT00466947|Secondary|Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807747|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset|S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807748|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807749|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.|||Subjects|||Number
2807750|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae|No subject was reported with any case of ID due to Haemophilus influenzae.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25||2050-12-31|12/2050||||
2807751|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.|The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807752|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807753|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)|A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807754|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).|A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807755|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).|A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807756|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off.|CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807757|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading|A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807758|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)|"An abnormal CXR was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs."|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807759|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)|An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807760|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).||Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807789|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed|||units on a scale||Standard Error|Mean
2807823|NCT00466661|Primary|Time to First Drink (Days)|Number of days after randomization until consumption of first alcoholic beverage per self-report.|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||Days||95% Confidence Interval|Mean
2807761|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)|"An abnormal CXR was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs."|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807762|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)|A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807763|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset|Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807764|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807765|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807766|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.|Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807767|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807768|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset|The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807815|NCT00466661|Secondary|Clinical Global Impression Scale Score|Higher values indicate worse outcomes; minimum value = 1, maximum value = 7|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
2807770|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)|CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807771|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks after Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.|||Subjects|||Number
2807772|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.|||Subjects|||Number
2807773|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.|||Subjects|||Number
2807774|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration.|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.|||Subjects|||Number
2807775|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.|||Subjects|||Number
2807776|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.|||Subjects|||Number
2807777|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.|||Subjects|||Number
2807778|NCT00466947|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the Panama subset.|||Subjects|||Number
2807779|NCT00466947|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study.|||Subjects|||Number
2807816|NCT00466661|Secondary|Young Mania Rating Scale Score|YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
2807824|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 2|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 2|on-study week 9||||ng/mL||Standard Deviation|Mean
2807780|NCT00466947|Primary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)|A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.|Any time from 2 weeks after Dose 3 up to 31 August 2010|Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of 31 August 2010.|||Subjects|||Number
2807781|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed|||units on a scale||Standard Error|Mean
2807782|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment.|only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed|||units on a scale||Standard Error|Mean
2807783|NCT00466817|Secondary|Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed|||units on a scale||Standard Error|Mean
2807784|NCT00466817|Secondary|Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed|||units on a scale||Standard Error|Mean
2807785|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed|||units on a scale||Standard Error|Mean
2807786|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed|||units on a scale||Standard Error|Mean
2807787|NCT00466817|Secondary|Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed|||units on a scale||Standard Error|Mean
2807788|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed|||units on a scale||Standard Error|Mean
2807817|NCT00466661|Secondary|Montgomery Asberg Depression Rating Scale Score|MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60.|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
2807790|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed|||units on a scale||Standard Error|Mean
2807791|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed|||units on a scale||Standard Error|Mean
2807792|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed|||units on a scale||Standard Error|Mean
2807793|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed|||units on a scale||Standard Error|Mean
2807794|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed|||units on a scale||Standard Error|Mean
2807795|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.|||ears|||Number
2807796|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods|||ears|||Number
2807818|NCT00466661|Secondary|Obsessive Compulsive Drinking Scale Score|Higher scores indicate worse outcome; minimum score = 0, maximum score = 40|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||score on a scale||Standard Deviation|Mean
2807819|NCT00466661|Secondary|Gamma-glutamyltransferase|Measured levels of validated serum alcohol biomarker|8 weeks|Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30).|||Gamma-glutamyltransferase U/L||Standard Deviation|Mean
2811965|NCT00438100|Secondary|Antitumor Effects||The follow up period will be two years after the last dose has been administered.|||||||
2807797|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported|||ears|||Number
2807798|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.|||ears|||Number
2807799|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 12 months|Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed.|||ears|||Number
2807800|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported|||ears|||Number
2807801|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 24 Months.|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods|||participants|||Number
2807825|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 2|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 2|on-study week 9||||ng/mL||Standard Deviation|Mean
2807802|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 12 Months.|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods|||participants|||Number
2807803|NCT00466817|Secondary|Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.|Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.|baseline through 7 months||||participants|||Number
2807804|NCT00466817|Primary|Change in Best Ear Hearing Assessments at 6 Months.|"Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving total ear classifications. Following this, the study audiologist assigned the best ear classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the best ear classification was mild hearing loss."|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported|||participants|||Number
2807805|NCT00466752|Secondary|Number of Participants With at Least 25% Reduction in PSA|Proportion of Patients with at least 25% decline in PSA on Day 1 of Cycle 2, Day 1 of Cycle 3, and on day of radical prostatectomy.|Day 1 of cycles 2 and 3 and on the day of radical prostatectomy. Each cycle is 2 weeks.|One patient did not have lab samples collected on day of radical prostatectomy.|||Participants|||Count of Participants
2807806|NCT00466752|Secondary|Number of Participants With Complete Pathologic Response|Proportion of Patients with at least 50% decline in PSA on Day 1 of Cycle 2, Day 1 of Cycle 3, and on day of radical prostatectomy.|Day 1 of cycles 2 and 3, and day of radical prostatectomy. Each cycle is 2 weeks.|One patient did not have lab samples collected on day of radical prostatectomy.|||Participants|||Count of Participants
2807807|NCT00466752|Primary|Efficacy as Assessed by Number of Patients With Changes Across Transcript Profiles by Microarray Analysis in Prostate Cancer Specimens, Specifically Those With Complete Pathologic Response.|Determined by changes across transcript profiles, by microarray analysis, in pre- versus post-treatment prostate cancer specimens (minimum 50 day time frame between these). Proportion of patients with complete pathologic response.|Pre- versus post-treatment|Data not collected||||||
2807808|NCT00466726|Secondary|Number of Patients With Peptide-specific Immune Response Induced by the Vaccinations|A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation|At 9 months||||participants|||Number
2807809|NCT00466726|Secondary|Number of Patients With Undetectable Transcript at Any Time After Immunization||Up to 6 months||||participants|||Number
2807810|NCT00466726|Primary|Number of Patients Showing a Reduction by at Least 50% of Peripheral Blood BCR-ABL/ABL Ratio Compared to the Individual Prevaccine Level|Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)|At 6 and 9 months||||participants|||Number
2807811|NCT00466687|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 28-day cycle for 6 cycles (168 days)|Patients who received the study drug and who experienced a toxicity. Eleven patients did not experience any toxicity and are therefore not included in the analyzed population for this outcome measure.|||participants|||Number
2807812|NCT00466687|Secondary|Progression-free Survival at 6 Months|Patients with Progression-free survival at 6 months|6 months|Those patients who were progression-free at 6 months from study entry. No date of progression was available for 7 patients|||participants|||Number
2807813|NCT00466687|Secondary|Time to Disease Progression.|Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions.|up to one year after off-study date|Patients with disease progression. Six patients were not available for determination to progression: no data (5) and toxicity (1).|||Months||Full Range|Median
2807814|NCT00466687|Primary|Number of Patients With Response|Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At 6 months|Patients for whom a response could be determined. Three patients were not available for measurement of response: no data (2) and toxicity (1).|||participants|||Number
2807828|NCT00466505|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death.|On study date to off study date in this study with median 9.76 months||||patients|||Number
2807829|NCT00466505|Secondary|One Year Survival Rate|Percent of patients who remain alive one year from on-study date|1 year from on-study date||||Percentage of participants||95% Confidence Interval|Number
2807830|NCT00466505|Secondary|Overall Survival|Median survival time in months, from on-study date to date of death|On study date to off study date in this study with median 9.76 months||||Months||Inter-Quartile Range|Median
2807831|NCT00466505|Secondary|Patient Response to Treatment|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|On study date to off study date in this study with median 9.76 months||||participants|||Number
2807832|NCT00466505|Primary|Progression-free Survival (PFS)|Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions|On study date to off study date in this study with median 9.76 months||||Days||Full Range|Median
2807833|NCT00466323|Primary|Family-Clinician Contact (Not Including Notes From FMPO Clinicians)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||Number of Interactions||Standard Deviation|Mean
2807834|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales. This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery.|Within 6 month of the intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||units on a scale||Standard Deviation|Mean
2807835|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM Total Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery.|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||Units on a Scale||Standard Deviation|Mean
2807836|NCT00466323|Primary|Family-Clinician Contact (Including Contact With FMPO Clinician)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.|||Number of Interactions||Standard Deviation|Mean
2807837|NCT00466310|Primary|Total Plasmalogen Levels in the Lipid Profile|Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.|Baseline|17 of the 31 available controls were age and BMI matched to the schizophrenia subjects.|||nmoles/gram||Standard Deviation|Mean
2807838|NCT00466206|Primary|Efficacy: Patient Recommendation of Treatment|"Based on patient response to one-year post-explantation QoL statement: I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum. Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree"|One year post-explanation|Per protocol|||Scores on a scale||Standard Deviation|Mean
2807839|NCT00466206|Primary|Efficacy: Patient Satisfaction|Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied|One year post-explant|Per protocol|||Scores on a scale||Standard Deviation|Mean
2807840|NCT00466206|Primary|Damage/Discoloration to Skin|Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear|One-month post-explant|Per protocol|||participants|||Number
2807841|NCT00466206|Secondary|Patient Compliance|Compliance measured by average number of hours per day external device was worn by patient, as measured by the data sensor and logging device built into external prosthetic|18 months active Rx|Per protocol|||avg hours per day brace worn||Full Range|Mean
2807842|NCT00466206|Primary|Affect on Cardiac Activity|EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.|One month post-explantation|Per protocol, this is a single-arm, pilot study of ten subjects.|||participants|||Number
2807843|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.|Weeks 1 to 4|Safety population: participants who took at least one dose of study medication post-randomization.|||units on a scale||95% Confidence Interval|Least Squares Mean
2807844|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
2811966|NCT00438100|Secondary|Adverse Events||The follow up period will be two years after the last dose has been administered.|||||||
2807845|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.|Weeks -1 to 0|Safety population: participants who took at least one dose of study medication post-randomization.|||units on a scale||95% Confidence Interval|Least Squares Mean
2807846|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
2807847|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
2807848|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
2807849|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||percentage of participants|||Number
2807850|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
2807851|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
2807852|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.|||minutes||95% Confidence Interval|Least Squares Mean
2807853|NCT00466167|Secondary|Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)||baseline and week 18|Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).|||participants|||Number
2807854|NCT00466167|Secondary|Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18|"Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for no pain to ten for unbearable pain."|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2807855|NCT00466167|Secondary|Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks|ranging from 0 (worst case) to 100 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807856|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks|Ranging from 0 (best case) to 156 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807857|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks|ranging from 0 (worst case) to 150 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807858|NCT00466167|Secondary|Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks|ranging from 0 (best case) to 63 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807860|NCT00466167|Secondary|Change From Baseline in UPDRS III Score After 18 Weeks|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807861|NCT00466167|Secondary|Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
2807862|NCT00466167|Secondary|Change From Baseline in UPDRS I Score After 18 Weeks|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Units on a scale||Inter-Quartile Range|Median
2807863|NCT00466167|Secondary|Response in Patient Global Impression (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Participants|||Number
2807864|NCT00466167|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Participants|||Number
2807865|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of on-time||Standard Error|Least Squares Mean
2807866|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of on-time||Standard Error|Least Squares Mean
2807867|NCT00466167|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of on-time without dyskinesia||Standard Error|Least Squares Mean
2807868|NCT00466167|Secondary|Change From Baseline in Percentage Off-time at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).|||Percentage of off-time||Standard Error|Least Squares Mean
2807869|NCT00466167|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and week 18|Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment|||Percentage of change from baseline||Standard Error|Least Squares Mean
2807870|NCT00465998|Secondary|Delivery Within 24 Hours|Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.|Time from induction to delivery|Hazard ratio was reported.|||Hazard ratio||95% Confidence Interval|Number
2807871|NCT00465998|Primary|Vaginal Delivery in Induced Labors|The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head-perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.|Time from induction of labor to delivery||||percentage of area under the ROC curve||95% Confidence Interval|Number
2807872|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.||48 weeks after study start|Intention to treat (ITT) population.|||pg/mL||Standard Deviation|Mean
2807873|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.||32 weeks after study start|Intention to treat (ITT) population.|||pg/mL||Standard Deviation|Mean
2807874|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.||until Week 8|Intention to treat (ITT) population.|||pg/mL||Standard Deviation|Mean
2807875|NCT00465985|Primary|Number of Participants Who Experienced a Disease Flare in Part II|Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) > 30 mg/L and either a PGA > minimal, or PGA equal to minimal and > minimal SD.|32 weeks after study start||||Participants|||Number
2807876|NCT00465985|Secondary|Pharmacokinetics (CLD (L/d))|Assessed serum clearance of ACZ885.|48 weeks after study start|Patients in Part I and Part II who received at least one dose of ACZ885.|||L/day||Standard Deviation|Mean
2807877|NCT00465985|Secondary|Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.||Week 8 and Week 32|Intention to treat (ITT)population and LOCF.|||mg/L||Standard Deviation|Mean
2811967|NCT00438100|Primary|Progression Free Survival||The follow up period will be two years after the last dose has been administered.||||years||95% Confidence Interval|Median
2807878|NCT00465985|Secondary|Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)|"A 5-point scale was used for the Physician's global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items:~skin disease (urticarial skin rash)~arthralgia~myalgia~headache/migraine~conjunctivitis~fatigue/malaise~other symptoms related to autoinflammatory syndrome~other symptoms not related to autoinflammatory syndrome"|32 weeks after study start||||Participants|||Number
2807879|NCT00465985|Secondary|Number of Participants With Treatment Response in Part I (After 8 Weeks)|Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by >30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA > 30 mg/L and either PGA > minimal or PGA = minimal and SD > minimal. Non-responders = no PR by Day 8 or no CR by Day 15.|8 weeks after study start||||Participants|||Number
2807880|NCT00465985|Primary|Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)|Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.|32 weeks after study start||||percent of participants|||Number
2807881|NCT00465972|Secondary|Change in Piper Fatigue Scale at 3 Months|A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2807882|NCT00465972|Primary|Response: Change in Insomnia Severity Rating Scale at 3 Months.|Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.|Baseline and 3 months|This is the LOCF population|||units on a scale||Standard Deviation|Mean
2807883|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)|"As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied."|Baseline through 52 Weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
2807884|NCT00465894|Secondary|Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)|Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.|Baseline through 52 weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
2807885|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|Baseline through 52 weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2807886|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|Baseline through 52 weeks|At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2807887|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)|"As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied."|Baseline through 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
2807888|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)|Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.|Baseline through 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||percentage of participants|||Number
2807889|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|Baseline to 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2808363|NCT00462722|Secondary|Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise groups had uninterpretable hip scans."|||percentage change in BMD||Standard Deviation|Mean
2807890|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|Baseline to 24 weeks|At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2807891|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary|Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.|From baseline through 12 weeks of Intervention|25 patients in each group completed voiding diary at baseline. 21 patients completed the voiding diary at 12 weeks in the Tolterodine group (complete diary). 25 patients in the estradiol group completed diary at 12 weeks. Incomplete diaries were not included in our analysis.|||events||Standard Deviation|Mean
2807892|NCT00465894|Secondary|Subjective Patient Change in Irritative Urinary Symptoms|"This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, How satisfied are you with your progress since your treatment in which the 3 possible responses are completely satisfied, somewhat satisfied, and not satisfied. The goal of treatment was to move all participants to completely satisfied."|From baseline through 12 Weeks of Intervention|In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. For this outcome ONLY, 1 patient from each Group were not available to obtain the measurements from this questionnaire. Therefore the overall number of participants analyzed for this outcome is less than other outcomes. Please see Participant Flow.|||participants|||Number
2807893|NCT00465894|Secondary|Evaluate Subjective Patient Change in Irritative Urinary Symptoms|"Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.~Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement."|From baseline through 12 Weeks of Intervention|In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow.|||participants|||Number
2807894|NCT00465894|Secondary|Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)|Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|From baseline through 12 Weeks of Intervention|In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow.|||units on a scale||Standard Deviation|Mean
2807895|NCT00465894|Primary|Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|From baseline through 12 Weeks of Intervention|A baseline measure was achieved for Group 1 with 30 patients and Group 2 with 28 patients. At the 12 week measurement period, we were unable to analyze 5 patients in Group 1 (leaving 25 patients) and unable to analyze 3 patients in Group 2 (leaving 25 patients). These participants left for reasons identified in the Participant Flow.|||units on a scale||Standard Deviation|Mean
2807896|NCT00465816|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
2807897|NCT00465816|Secondary|Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits||During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
2807898|NCT00465816|Secondary|Number of Subjects Reporting Any Rash|Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
2807899|NCT00465816|Secondary|Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses|Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
2807900|NCT00465816|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to 1 month after each vaccine dose|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.|||Participants|||Count of Participants
2807901|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.|During a 4-day period (Days 0-3) after each vaccine dose and across doses|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet.|||Participants|||Count of Participants
2808364|NCT00462722|Secondary|Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training||||percentage change in BMD||Standard Deviation|Mean
2807902|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination|Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed.|||Participants|||Count of Participants
2807903|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination|Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 4-day period (Days 0-3) after Nimenrix vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.|||Participants|||Count of Participants
2807904|NCT00465816|Secondary|Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||Participants|||Count of Participants
2807905|NCT00465816|Secondary|IgG Anti-HBs Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
2807906|NCT00465816|Secondary|Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||Participants|||Count of Participants
2807907|NCT00465816|Secondary|Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
2807908|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||Participants|||Count of Participants
2807909|NCT00465816|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2807910|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
2807911|NCT00465816|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7|The rSBA titers were expressed as geometric mean titers.|At 7 months after vaccination with Nimenrix (At Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2807912|NCT00465816|Secondary|Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value|The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
2807913|NCT00465816|Secondary|Anti-Tetanus Toxoid (TT) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||International Units per milliliter||95% Confidence Interval|Geometric Mean
2807914|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||Participants|||Count of Participants
2807915|NCT00465816|Secondary|Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2807916|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
2807917|NCT00465816|Secondary|Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135|Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Participants|||Count of Participants
2807918|NCT00465816|Primary|Number of Subjects Seroprotected for Hepatitis B|A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.|||Participants|||Count of Participants
2807919|NCT00465816|Primary|Number of Subjects Seroconverted for Hepatitis A|A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine.|||Participants|||Count of Participants
2807920|NCT00465816|Primary|Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers|The rSBA titers were expressed as geometric mean titers (GMTs).|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2807921|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807922|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807923|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807924|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807925|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807926|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807927|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807928|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807929|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807930|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807931|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2808051|NCT00464685|Secondary|Change From Baseline in the Focal Leakage Area in the Study Eye|Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 12|Intent to Treat: all randomized patients|||Millimeters Squared (mm^2)||Standard Deviation|Mean
2807932|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807933|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807934|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807935|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807936|NCT00465738|Secondary|Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set|The patient's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Full Analysis Set|||units on a scale||Standard Error|Mean
2807937|NCT00465738|Secondary|Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set|The investigator's global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||units on a scale||Standard Error|Mean
2807938|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
2807939|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
2807940|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
2807941|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||degree||Standard Error|Mean
2807942|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807943|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807944|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807945|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807946|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807947|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807948|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807949|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807950|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807951|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807952|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807953|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807954|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807955|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2808082|NCT00464620|Secondary|"Median Time-to-progression of Subjects With Indolent Sarcomas Treated With Dasatinib."|"To estimate the median time-to-progression of subjects with indolent sarcomas treated with dasatinib."|Up to 24 months||||months||Full Range|Median
2807956|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set|"Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a catch when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension."|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807957|NCT00465738|Secondary|Responder in FAT at Follow up - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807958|NCT00465738|Secondary|Responder in FAT at Week 12 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807959|NCT00465738|Secondary|Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807960|NCT00465738|Secondary|Responder in DAS at Follow up - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807961|NCT00465738|Secondary|Responder in DAS at Week 12 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807962|NCT00465738|Secondary|Responder in DAS at Week 4 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.|||participants|||Number
2807963|NCT00465738|Primary|Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set|The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.|At week 4|Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint.|||participants|||Number
2807964|NCT00465647|Secondary|Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time|"The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age."|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).|||unit on a scale||Standard Error|Mean
2807965|NCT00465647|Secondary|Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time|Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.|Immediately prior to first oral dose with potentially up to 54 hours duration.|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).|||units on a scale||Standard Error|Mean
2807966|NCT00465647|Secondary|Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]|There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).|||units on a scale||Standard Error|Mean
2808083|NCT00464620|Secondary|Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.|To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.|At 2 and 5 years||||Participants|||Count of Participants
2807967|NCT00465647|Primary|Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)|"Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study.~Efficacy was based on Oral treatment only."|A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.|The full analysis population for Pharmacokinetics/ Pharmacodynamics consisted of subjects who received at least 1 dose of oral hydromorphone HCl, and had at least 1 valid quantifiable PK sample. To be a valid sample, the time of administration of each dose of oral hydromorphone HCl, the dose, and the time of sample collection must be recorded.|||L/hour||95% Confidence Interval|Number
2807968|NCT00465595|Primary|HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).|"The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety.~For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A"|Baseline, 5 weeks post session 1 and 2, 6-month follow-up||||units on a scale||Standard Error|Mean
2807969|NCT00465595|Primary|GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.|The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD|Baseline, 5 weeks post session 1 and 2, 6-month follow-up||||units on a scale||Standard Error|Mean
2807970|NCT00465569|Secondary|Changes in Cow Milk Immunoglobulin G4 (IgG4)|IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks|Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation|||percentage of change||Full Range|Median
2807971|NCT00465569|Secondary|Changes in Cow Milk-IgE|IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks|Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation|||percentage of change||Full Range|Median
2807972|NCT00465569|Primary|The Median Milk Threshold Dose Inducing a Reaction||Baseline and 23 weeks|One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation. The median milk threshold dose in both groups was 40 with a full range of 40-1340 at the baseline challenge.|||miligrams||Full Range|Median
2807973|NCT00465530|Primary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|3 Weeks to Follow-Up (7 Weeks)||||units on a scale||Standard Deviation|Mean
2807974|NCT00465530|Secondary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|Baseline to 3 Weeks||||units on a scale||Standard Deviation|Mean
2807975|NCT00465530|Primary|Change in Computed Tomography (CT) Score After Treatment|Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification.|Change from Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
2807976|NCT00465361|Primary|Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit|Residents were observed to determine whether specific aspects of infant developmental status, as part of developmental surveillance, were assessed during the two-month preventive care visit. The components of developmental surveillance observed were: assessment of the infant's ability to follow past midline, assessment of the infant's ability to lift his/her head off of the table in prone, assessment of the infant's ability to hold an object placed in his/her hand, assessment of the infant's ability to coo, and assessment of the infant's ability to demonstrate a social smile.|Residents were observed during each of the eligible preventive care visits. Each visit was an average of 20 minutes in length. Preventive care visits were observed over a 13 month time period.||||Participants|||Number
2807977|NCT00465270|Post-Hoc|Rate of Recurrent Nonfatal Stroke, Post-randomization Death, and Fatal Ischemic Stroke Through Long Term Follow-up||Long Term Follow-up, median of 5.9 years||||Participants|||Count of Participants
2807978|NCT00465270|Secondary|Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group||6 months|Only subjects with complete PFO closure data at 6-months were analyzed.|||Participants|||Count of Participants
2807979|NCT00465270|Primary|Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization|"Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.~Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last."|Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.|All primary endpoints that occurred in the trial were recurrent non-fatal ischemic strokes.|||Participants|||Count of Participants
2807980|NCT00465179|Secondary|Median Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.||||months||95% Confidence Interval|Median
2808084|NCT00464620|Secondary|Median Time-to-progression of Subjects With GIST Treated With Dasatinib.|To estimate the median time-to-progression of subjects with GIST treated with dasatinib.|Up to 30 months||||months||Full Range|Median
2807981|NCT00465179|Primary|Median Progression-Free Survival (PFS)|Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.|||months||95% Confidence Interval|Median
2807982|NCT00465179|Primary|Number of Participants With Response to Treatment|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.|||participants|||Number
2807983|NCT00465101|Secondary|Occurrence of Retrograde Ejaculation|Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.|5 Year Follow Up|Participants who received the study treatment|||percentage of subjects with RE||95% Confidence Interval|Number
2807984|NCT00465101|Other Pre-specified|Total Joules Used|Total energy applied during the study procedure|Procedure|Participants who received the study treatment and for whom the outcome measure is available.|||kilojoules (kJ)||Standard Deviation|Mean
2807985|NCT00465101|Other Pre-specified|Number of Fibers Used During Procedure||Procedure|Participants who received the study treatment and for whom the outcome is available.|||number of fibers used||Standard Deviation|Mean
2807986|NCT00465101|Other Pre-specified|Length of Lasing (LOL)|Total time the laser was on during the study procedure.|Procedure|Participants who received the study treatment and for whom the outcome measure is available.|||minutes||Standard Deviation|Mean
2807987|NCT00465101|Other Pre-specified|Length of Procedure (LOP)|Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).|Procedure|Participants who received the study treatment and for whom the outcome measure is available.|||minutes||Standard Deviation|Mean
2807988|NCT00465101|Other Pre-specified|Length of Catheterization (LOC)|Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).|Recovery Period|Participants who received the study treatment and for whom the outcome measure is available.|||hours||Standard Deviation|Mean
2807989|NCT00465101|Other Pre-specified|Length of Hospital Stay (LOS)|Defined as the time from admission to the healthcare facility until discharge (in hours).|Peri-Operative Period|Participants who received the study treatment and for whom the outcome measure is available.|||hours||Standard Deviation|Mean
2807990|NCT00465101|Secondary|Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.||Up to five years|Participants who received the study treatment and for whom the outcome measure is available.|||days||Standard Deviation|Mean
2807991|NCT00465101|Secondary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.|5 Years|Participants who received the study treatment and for whom the outcome measure is available.|||Percent of subjects w/ treatment success||95% Confidence Interval|Number
2807992|NCT00465101|Secondary|Gross Hematuria|Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.|91 days|Participants who received the study treatment|||Percentage of subjects|||Number
2807993|NCT00465101|Secondary|Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.|"Participant response to the question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Values range from 0 (Delighted) to 6 (Terrible) with higher values indicating worse outcomes."|5 years|Participants who received the study treatment and for whom the outcome measure is available.|||Score on a scale||Standard Deviation|Mean
2807994|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.|A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.|||percentage of patients improved||95% Confidence Interval|Number
2807995|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Uroflow.|A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.|||percentage of patients improved||95% Confidence Interval|Number
2807996|NCT00465101|Secondary|Treatment-related Complication|"Treatment-related events include the following:~Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization~Perforation / injury of adjacent organ(s)~Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal~Hematuria requiring transfusion~Urinary retention requiring corrective intervention~De novo erectile dysfuction (ED)~Transfusion secondary to procedure-related anemia~Post procedure incontinence secondary to damage to the external urinary sphincter~Any other treatment-related injury requiring intervention"|3 months|Participants who received the study treatment.|||percentage of subjects with complication||95% Confidence Interval|Number
2807997|NCT00465101|Primary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50%|6 months|Participants who received the study treatment and for whom the outcome measure is available.|||percentage of participants|||Number
2808365|NCT00462722|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable spine scans."|||percentage change in BMD||Standard Deviation|Mean
2807998|NCT00465088|Secondary|Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12|NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters|||Percentage of subjects|||Number
2807999|NCT00465088|Secondary|Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12||12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value|||Percentage of subjects|||Number
2808000|NCT00465088|Secondary|Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12|For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value|||Percentage of subjects|||Number
2808001|NCT00465088|Secondary|Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12||12 weeks|All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value|||Percentage of subjects|||Number
2808002|NCT00465088|Secondary|Percent Change in Lipoprotein A From Baseline to Week 12|(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||Inter-Quartile Range|Median
2808003|NCT00465088|Secondary|Percent Change in Total Cholesterol:HDL-C Ratio|(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808004|NCT00465088|Secondary|Percent Change in Total Cholesterol From Baseline to Week 12|(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808005|NCT00465088|Secondary|Percent Change in LDL-C:HDL-C Ratio|(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808006|NCT00465088|Secondary|Percent Change in Triglycerides From Baseline to Week 12|(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||Inter-Quartile Range|Median
2808007|NCT00465088|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12|(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)|||percent change||95% Confidence Interval|Least Squares Mean
2808008|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 12|(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808009|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 8|(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808010|NCT00465088|Secondary|Percent Change in HDL-C From Baseline to Week 8|(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808011|NCT00465088|Primary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12|(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window|||percent change||95% Confidence Interval|Least Squares Mean
2808012|NCT00464945|Primary|Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population were participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2808013|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after toddler dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2808025|NCT00464815|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value|The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2808014|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2808015|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2808016|NCT00464945|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2808017|NCT00464815|Secondary|Number of Subjects With Specific Adverse Events|These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).|Up to study end (Month 6)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2808018|NCT00464815|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end (Month 6)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2808019|NCT00464815|Secondary|Number of Subjects With Any Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2808020|NCT00464815|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 4-day (Days 0-3) period after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
2808021|NCT00464815|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).|During the 4-day (Days 0-3) period after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
2808022|NCT00464815|Secondary|Anti-meningococcal Polysaccharide Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||μg/mL||95% Confidence Interval|Geometric Mean
2808023|NCT00464815|Secondary|Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values|The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2808024|NCT00464815|Secondary|Anti-TT Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
2808026|NCT00464815|Secondary|Meningococcal rSBA Antibody Titers|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Titer||95% Confidence Interval|Geometric Mean
2808027|NCT00464815|Secondary|Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values|Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to (Month 0) and one month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2808028|NCT00464815|Primary|Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms|General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).|During the 4-day (Days 0-3) period after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2808029|NCT00464815|Primary|Number of Subjects With Vaccine Response to Meningococcal Antigens|Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].|One month post-vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2808030|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 50, 33 and 22 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.|||score on a scale||Standard Deviation|Mean
2808031|NCT00464737|Secondary|Number of Subjects With Presence of Impulse Control Disorders|Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
2808032|NCT00464737|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase|The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
2808033|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
2808034|NCT00464737|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
2808035|NCT00464737|Secondary|Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 73 (Rotigotine 4 mg) and 74 (Rotigotine 8 mg) patients respectively in the Safety Set, a total of 41 and 20 patients respectively at the end of Maintenance Phase/Week 12 have this assessment.|||ug/ML||Standard Deviation|Mean
2808036|NCT00464737|Secondary|Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
2808037|NCT00464737|Secondary|Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2808038|NCT00464737|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 76, 58, and 51 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Patients|||Number
2808039|NCT00464737|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2808040|NCT00464737|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2808041|NCT00464737|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.||||||
2808042|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 80, 64 and 63 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
2808043|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2808044|NCT00464711|Primary|Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores|"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.~40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks."|12 weeks|40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.|||participants|||Number
2808045|NCT00464698|Secondary|Clinical Global Impressions Scale at Week 3 and Week 17|"Global severity of illness, such that a higher score reflects worse global severity~Minimum score: 2 Maximum score: 14"|Week 3 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
2808046|NCT00464698|Secondary|QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)|"Quality of life, such that lower score reflects poorer quality of life~Minimum score: 16 Maximum score: 80"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
2808047|NCT00464698|Secondary|BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)|"Anxiety severity, such that a higher score on the BAI reflects more severe anxiety.~Minimum value: 0 Maximum value: 63"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
2808048|NCT00464698|Secondary|BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).|"Depression severity, such that higher scores on the BDI are reflective of more severe depression.~BDI minimum score: 0 MDI maximum score: 63"|Week 0 to 17|20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.|||units on a self-report questionnaire||Standard Deviation|Mean
2808049|NCT00464698|Primary|Y-BOCS Scores at 1st and Last Visit|OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.|Week 0 to 17||||units on a scale||Standard Deviation|Mean
2808050|NCT00464685|Secondary|Time to Retreatment in the Study Eye|Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.|12 Months|Intent to Treat: all randomized patients|||Days||95% Confidence Interval|Median
2808366|NCT00462722|Primary|Change From Baseline in Fat-free Mass at 9 Months||Baseline and after 9 months of training||||change in kg||Standard Deviation|Mean
2808052|NCT00464685|Secondary|Change From Baseline in Central Subfield Retinal Thickness in the Study Eye|Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients|||Microns||Standard Deviation|Mean
2808053|NCT00464685|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients|||Letters Read Correctly||Standard Deviation|Mean
2808054|NCT00464685|Primary|Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2808055|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age|Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.|21 days after vaccination|The analysis was done on the per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2808056|NCT00464672|Secondary|Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.|Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.|7 days after each vaccination|The analysis was performed on the safety population.|||Participants|||Number
2808057|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age|To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP)population.|||Titers||95% Confidence Interval|Geometric Mean
2808058|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Mean
2808059|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP) population|||Percentage of participants||95% Confidence Interval|Mean
2808060|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age|Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.|7 days after vaccination|The analysis was performed on the safety population.|||Participants|||Number
2808061|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age|To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population|||Titers||95% Confidence Interval|Geometric Mean
2808062|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population.|||Percentage of participants||95% Confidence Interval|Mean
2808063|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of subjects||95% Confidence Interval|Mean
2808064|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age|Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.|7 days after vaccination|The analysis was performed on the safety population.|||participants|||Number
2808065|NCT00464672|Primary|Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Mean
2808367|NCT00462722|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable hip scans."|||percentage change in total hip BMD||Standard Deviation|Mean
2808066|NCT00464672|Primary|Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age|To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.|||Percentages of participants||95% Confidence Interval|Mean
2808067|NCT00464646|Secondary|Percentage of Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)||2-4 weeks after surgery and at 9 and 12 months from study entry|||||||
2808068|NCT00464646|Secondary|Overall Survival||From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry|||||||
2808069|NCT00464646|Secondary|Recurrence-free Survival||From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry|||||||
2808070|NCT00464646|Secondary|Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)||Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry|||||||
2808071|NCT00464646|Secondary|Clinical Complete Response (cCR)||Determined at baseline, between EC and docetaxel, and following docetaxel (before surgery)|||||||
2808072|NCT00464646|Secondary|pCR in the Breast (Cohort A)||Assessed at the time of surgery|||||||
2808073|NCT00464646|Primary|Cardiac Event Rate as Determined by LVEF Assessment||Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.|||||||
2808074|NCT00464646|Primary|Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)|The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.|Assessed at time of surgery on average at 8 months|73 of the 76 patients in Cohort A were analyzed: 2 patients did not have surgery and 1 patient did not have the nodal status determined.|||participants|||Number
2808075|NCT00464620|Secondary|Number of Participants With Tumors With Mutations in Kinases|Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis.|Up to 37 weeks|The overall number of participants analyzed demonstrates the number of participants whose tumor samples were received. The results illustrate the tissue that was able to generate tissue microarray for PDGFR analysis.|||Participants|||Count of Participants
2808076|NCT00464620|Secondary|Number of Participants With Tumors With Kinase Expression|Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression.|Up to 37 weeks|The overall number of participants analyzed demonstrates the number of participants whose tumor samples received. The results illustrate the tissue that was able to generate tissue microarray for SRC and FAK analysis.|||Participants|||Count of Participants
2808077|NCT00464620|Secondary|Plasma Level of Dasatinib and Inhibition of SRC and/or Focal Adhesion Kinase (FAK) in Peripheral Blood Mononuclear Cells|Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study.|2-4 weeks from start of treatment|Evaluation of blood levels of drug was not performed because there was insufficient activity and the level of activity did not warrant further study.||||||
2808078|NCT00464620|Secondary|Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung|To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung|Up to 37 weeks|This data was not collected because the imaging software and work station was not obtained.||||||
2808079|NCT00464620|Secondary|Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.|To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.|At 2 and 5 years|The number analyzed in one or more rows differs from overall number because the rows are broken down into cohorts. The counts in the categories will not add up to the number analyzed, because those numbers represent number of participants that have reached overall survival at 2 and 5 years.|||participants|||Number
2808080|NCT00464620|Secondary|Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.|To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.|Up to 37 weeks||||months||Full Range|Median
2808081|NCT00464620|Secondary|6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.|To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.|At 6 months|The numbers analyzed in one or more rows are different because they are broken up by cohorts.|||Participants|||Count of Participants
2808085|NCT00464620|Primary|6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)|To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.|6 months||||Participants|||Count of Participants
2808086|NCT00464620|Primary|"6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib"|"Estimate the 6 month progression-free survival rate of indolent sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass."|At 6 months||||Participants|||Count of Participants
2808087|NCT00464620|Primary|Response Rate: Number of Participants With Objective Tumor Response|Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.|Up to 24 months|116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. 50 patients enrolled in the GIST subtype, however 48 patients were evaluable. This explains the discrepancy between Overall Number of Participants Analyzed.|||Participants|||Count of Participants
2808088|NCT00464568|Secondary|Mean Levels of Total Vasodilator Stimulated Phosphoprotein (VASP) Protein, Phosphorylated(Phospho)157 VASP (pVASP) and phospho239 VASP in Lavage Cells|Nasal lavage were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal lavage samples were analyzed to explore the effects of GSK256066 on novel protein biomarkers including pVASP. Markers indicative of PDE4 inhibition such as VASP protein levels and phospho157 VASP were also measured in this study, in lavage cells, following positive data in an enabling study which showed increases in such protein levels in participants with allergic rhinitis following a single intranasal dose of salbutamol. Nasal lavage data from earlier studies showed that pVASP157 is the best marker and not pVASP239. pVASP239 was therefore not collected or analyzed as planned.|Day 1|All subjects population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
2808089|NCT00464568|Secondary|Nasal Lavage Concentrations of GSK256066|Nasal lavage samples were taken 2 -3 hour post morning dose and analyzed for GSK256066. Quantifiable levels of GSK256066 were observed in nasal lavage samples obtained 2-3 hours post-dose.|Day 1|PK concentration population.|||Picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2808090|NCT00464568|Secondary|Tmax and Tlast of Active Metabolite GSK614917|The PK of GSK614917 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Tmax and Tlast could not be determined for any participant at the 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population.|||Hour||Full Range|Median
2808091|NCT00464568|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) and Time to Last Observed Plasma Drug Concentration (Tlast) of GSK256066|The PK of GSK256066 were assessed in plasma by determining Tmax and Tlast. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.|Pre -dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK Parameter population. Only those participants with data available at the indicated time points were analyzed.|||Hour||Full Range|Median
2808092|NCT00464568|Secondary|Cmax of Active Metabolite GSK614917|The PK of GSK614917 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. C max was not calculable for any participant at the 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population. Only those participants with data available at the indicated time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2808093|NCT00464568|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) of GSK256066|The PK of GSK256066 were assessed in plasma by determining Cmax. All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK Parameter population. Only those participants with data available at the indicated time points were analyzed.|||Picogram per mililiter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2808094|NCT00464568|Secondary|AUC (0-last) of Active Metabolite GSK614917|The PK of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the study drug provided at least one sample for plasma PK analysis. AUC (0-last) was not calculable in any participant at the 1, 10 or 50 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population. Only those participants with data available at the indicated time points were analyzed.|||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
2808095|NCT00464568|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve (AUC0-last) of GSK256066|The pharmacokinetics (PK) of GSK256066 were assessed in plasma by determining AUC(0-last). All participants who received at least one dose of the active investigational product provided at least one sample for plasma PK analysis. Blood samples for PK were collected pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose and analyzed for GSK256066. AUC (0-last) was not calculable for any participant at 1 mcg GSK256066 dose.|Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1|PK parameter population comprised of all participants from the PK Concentration population (comprised of all participants from the All Subjects population for whom blood or nasal samples were taken for assaying study drug) for whom PK parameters were available. Only those participants with data available at the indicated time points were analyzed.|||Picogram*hour per milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2808096|NCT00464568|Secondary|Number of Participants With Clinical Chemistry Values of Potential Clinical Concern|Blood samples for clinical chemistry were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with clinical chemistry values of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for total bilirubin levels (clinical concern upper value: >31 micromole/liter) and inorganic phosphorus level (normal range: 0.7-1.5 millimole/liter).|Up to 9 weeks|All subjects population.|||Participants|||Number
2808097|NCT00464568|Secondary|Number of Participants With Hematology Values of Potential Clinical Concern|Blood samples for hematology were taken before dosing. Whole blood samples were collected and processed according to the local procedures at site. The samples were transferred to the local laboratory for analysis. The participants with hematology of potential clinical concern are reported. The potential clinical concern ranges (low and high) were given as: for white blood cell count (clinical concern range: 3 to 20 giga cells/liter), neutrophils (normal range: 2.1 to 10.0 giga cells/liter), hemoglobin (clinical concern upper value: >180 grams/liter). Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 9 weeks|All subjects population.|||Participants|||Number
2808098|NCT00464568|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 9 weeks|All subjects population.|||Participants|||Number
2808099|NCT00464568|Secondary|Change From Baseline in Electrocardiogram (ECG) Values|Electrocardiogram variables evaluated included PR interval, QRS duration, QT interval, QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) and RR interval. ECG was performed pre-dose, one hour and four hour post-dose. The ECG measurements were made with the participant in a supine position having rested in this position for at least 10 minutes before each time-point. Baseline was defined as the pre-dose measurement on Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values|Baseline (Day 1) to 9 weeks|All subjects population.|||Millisecond (msec)||Standard Deviation|Mean
2808100|NCT00464568|Secondary|Mean Heart Rate Over Study Period|Vital signs included heart rate. Heart rate was measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.|Up to 9 weeks|All subjects population.|||Beats/minute||Standard Deviation|Mean
2808101|NCT00464568|Secondary|Mean Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Over Study Period|Vital signs included SBP and DBP. SBP and DBP were measured pre-dose. The measurements were taken at 5 minutes interval during each treatment period. Vital signs measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before the first reading at each time point. Measurements that deviated substantially from previous readings were repeated immediately.|Up to 9 weeks|All subjects population.|||Millimetres of mercury (mmHg)||Standard Deviation|Mean
2808102|NCT00464568|Secondary|Mean Forced Expiratory Volume in One Second (FEV1)|The FEV1 is the volume of air forcefully exhaled in 1 second. The highest FEV1 value amongst the three recorded FEV1 readings was used for all FEV1 calculations. FEV1 was recorded pre-dose and at follow-up.|Up to 9 weeks|All subjects population.|||Liters (L)||Standard Deviation|Mean
2808103|NCT00464568|Primary|Mean Messenger Ribonucleic Acid (mRNA) Concentrations as a Measure of Gene Expression|The effect of GSK256066 on ribonucleic acid (RNA) levels indicative of Phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples was evaluated. Nasal lavage and scrapes were taken 2 to 3 hour post morning dose; bilateral nasal lavage was conducted before the scrape. Nasal scrape samples were taken from alternate nostrils. The novel RNA markers presented are cAMP responsive element modulator (CREM), dual specificity phosphatase 1(DUSP1), fos-like antigen 2(FOSL2), insulin receptor substrate 2 (IRS2), nuclear receptor subfamily 4, group A, member 2 (NR4A2), Phosphodiesterase-4A (PDE4A), Regulator of G-protein signalling 1 (RGS1), Serine/threonine protein kinase SNF1 like kinase (SNF1LK). Nasal lavage cytospins were stained with a SNF1LK specific monoclonal antibody by indirect immunofluorescence. Adjusted Geometric Mean and Standard error logs are presented.|Day 1|All Subjects population comprised of all participants randomized to treatment who received at least one dose of study treatment (including placebo).|||COPIES/50 nanogram (NG)||Standard Error|Geometric Mean
2808104|NCT00464542|Secondary|Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy|The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy|30 days after cessation of metronidazole therapy||||Days||Full Range|Median
2808105|NCT00464542|Primary|Number of Participants With Bacterial Vaginosis Recurrence|Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.|30 days after cessation of metronidazole therapy|per protocol|||Participants|||Number
2808106|NCT00464490|Primary|Mechanical Ventilation Time||time from first weaning attempt to successful extubation||||hours||Standard Deviation|Mean
2808107|NCT00464464|Primary|Hamilton Depression Rating Scale: Follow-Up Evaluation|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|14 weeks||||units on a scale||Standard Deviation|Mean
2808108|NCT00464464|Primary|Hamilton Depression Rating Scale: Endpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|10 weeks||||units on a scale||Standard Deviation|Mean
2808109|NCT00464464|Primary|Hamilton Depression Rating Scale: Midpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|5 weeks||||units on a scale||Standard Deviation|Mean
2808110|NCT00464464|Primary|Hamilton Depression Rating Scale: Baseline|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|0 weeks||||units on a scale||Standard Deviation|Mean
2808111|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7|"Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,~+3=severe)."|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"|||Percentage of Patients|||Number
2808112|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Lid Erythema|Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Days 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"|||Percentage of Patients|||Number
2808113|NCT00464438|Secondary|Percentage of Patients With Microbiological Improvement|Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"|||Percentage of Patients|||Number
2808114|NCT00464438|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7|Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria."|||Percentage of Patients|||Number
2808115|NCT00464334|Primary|Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies|The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.|Baseline and Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.|||fold change||95% Confidence Interval|Geometric Mean
2808116|NCT00464334|Primary|Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7|The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).|Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.|||ng/mL||95% Confidence Interval|Geometric Mean
2808117|NCT00464334|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 6 months after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.|||participants|||Number
2808118|NCT00464334|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 4 years after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.|||participants|||Number
2808119|NCT00464308|Secondary|The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods||4 weeks||||percent of participants||95% Confidence Interval|Mean
2808120|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|4 weeks||||participants|||Number
2808121|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks|Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe|||participants|||Number
2808122|NCT00464308|Primary|The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks||||participants|||Number
2808123|NCT00464308|Secondary|The Median Time to Complete Relief of Regurgitation Symptoms||4 weeks|ITT population|||days||95% Confidence Interval|Median
2808124|NCT00464308|Secondary|The Median Time to Complete Resolution of Heartburn Symptoms.||week 4 of treatment|ITT population|||days||95% Confidence Interval|Median
2808125|NCT00464308|Primary|The Number of Patients With Complete Resolution of Heartburn by Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|week 4 of treatment|The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).|||participants|||Number
2808126|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808127|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808128|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808129|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808170|NCT00463866|Secondary|Mean Overall Asthma Control Questionnaire (ACQ) Score|The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.|6 months.|Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.|||Scores in a scale||Full Range|Mean
2808130|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808131|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808132|NCT00464269|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
2808133|NCT00464269|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
2808134|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808135|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808144|NCT00464269|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
2808136|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808137|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808138|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||units on a scale||Standard Deviation|Mean
2808139|NCT00464269|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period|The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.|Baseline to 12-week Treatment Period|"The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period."|||percentage of participants|||Number
2808140|NCT00464269|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||days||95% Confidence Interval|Median
2808141|NCT00464269|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||days||95% Confidence Interval|Median
2808142|NCT00464269|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||days||95% Confidence Interval|Median
2808143|NCT00464269|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||percentage of participants|||Number
2808145|NCT00464269|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||Percent change in POS frequency||Inter-Quartile Range|Median
2808146|NCT00464269|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures.~All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||seizures per week||Inter-Quartile Range|Median
2808147|NCT00464269|Secondary|Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||participants|||Number
2808148|NCT00464269|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.|||seizures per week||Inter-Quartile Range|Median
2808149|NCT00464204|Other Pre-specified|Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification|"Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study.~RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy."|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug|||Participants|||Number
2808150|NCT00464204|Other Pre-specified|Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification|Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase >300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy.|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug|||Participants|||Number
2808151|NCT00464204|Other Pre-specified|Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening|Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening.|From screening to end of follow-up (up to day 90)|Treated population (TRT) = all randomized patients treated with study drug. Patients without ARF were excluded from analysis if they had no creatinine value at Screening or no post-screening creatinine value.|||Participants|||Number
2808152|NCT00464204|Other Pre-specified|Mortality|Mortality was reported for the time period from Screening until the end of follow-up.|From Screening to end of Follow-up|Treated population (TRT) = all randomized patients treated with study drug. Two patients in the Voluven® arm died due to non-treatment emergent SAEs.|||Participants|||Number
2808153|NCT00464204|Secondary|Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4|"The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC).~The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome)."|From Screening to Day 4|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Scores on a scale||Standard Deviation|Mean
2808154|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient."|||Days||Standard Deviation|Mean
2808155|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient."|||Days||Standard Deviation|Mean
2808156|NCT00464204|Secondary|Length of Stay in the ICU|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value).|Until discharge from ICU (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient."|||Days||Standard Deviation|Mean
2808157|NCT00464204|Secondary|Length of Stay in the Intensive Care Unit (ICU)|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from ICU (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient"|||Days||Standard Deviation|Mean
2808158|NCT00464204|Secondary|Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition|This amount will be calculated from start of enteral nutrition until 7 am of day 8|7 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||kcal||Standard Deviation|Mean
2808159|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization|Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.|up to 48 hours|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Hours||Standard Deviation|Mean
2808160|NCT00464204|Secondary|Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition|Time from start of fluid resuscitation with study drug to start of enteral nutrition.|Until start of enteral nutrition (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Hours||Standard Deviation|Mean
2808161|NCT00464204|Secondary|Quantity of Study Drug in 4 Days|Total quantity of study drug infused over four consecutive days in the ICU|4 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Milliliter||Standard Deviation|Mean
2808162|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization|Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization|||Hours||Standard Deviation|Mean
2808163|NCT00464204|Primary|Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization|Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.|||Milliliter||Standard Deviation|Mean
2808164|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after PCI||||participants|||Number
2808165|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after randomization, during PCI||||participants|||Number
2808166|NCT00464087|Secondary|Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis|Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis|during index hospitalization||||participants|||Number
2808167|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after Fondaparinux administration, prior to randomization||||participants|||Number
2808168|NCT00463866|Secondary|Mean Cost Per Participant Per Country|Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.|6 months|||||||
2808169|NCT00463866|Secondary|The Mean Total Daily Dose of Steroids From Symbicort.|The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.|4 weeks|: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.|||μg budesonide per day||Standard Deviation|Mean
2808368|NCT00462722|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Ibuprofen pre and placebo post exercise group had an uninterpretable spine scan."|||Percentage change in lumbar spine BMD||Standard Deviation|Mean
2808171|NCT00463866|Secondary|Percent of Participants With a Well Controlled Asthma Week.|The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.|6 months.|Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.|||Percentage of participants||Full Range|Mean
2808172|NCT00463866|Secondary|Mean Daily Number of Inhalations of As-needed Medication.|The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.|4 weeks|Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group|||Inhalations per day per participant||Full Range|Mean
2808173|NCT00463866|Secondary|Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation|Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.||||Days per participant||Standard Deviation|Mean
2808174|NCT00463866|Secondary|Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.|A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant|6 months.||||Number of events per participant||Full Range|Mean
2808175|NCT00463866|Secondary|Fraction of Participants With Severe Asthma Exacerbation|The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.||||Fraction of participants with event||95% Confidence Interval|Mean
2808176|NCT00463866|Primary|Number of Severe Asthma Exacerbations Per Participant.|Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months||||Severe exacerbations per participant||Full Range|Mean
2808177|NCT00463840|Secondary|Median Overall Survival|This is the time at which 50% of patients are alive from the trial entry .|up to 10 years since the start of the study|Secondary Measure was not reported. Contacted PI. No new Data available.||||||
2808178|NCT00463840|Primary|Resectability After Chemoradiation|This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).|7.5 weeks|Based on intent-to-treat population.|||participants|||Number
2808179|NCT00463801|Secondary|Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)||at day 14 and follow up day i.e. day 30|||||||
2808180|NCT00463801|Secondary|Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE||At day 14|||||||
2808181|NCT00463801|Secondary|Efficacy Assessed by Time of Resolution of Infection|Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).|At day 14|||||||
2808182|NCT00463801|Secondary|Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous||At day 14|||||||
2808183|NCT00463801|Secondary|Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10|To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|At day 4 and 10|||||||
2808184|NCT00463801|Secondary|Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria|To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.|At day 4, 7, 10 and 14|||||||
2808185|NCT00463801|Primary|Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start|Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|at Day 7 and 14|Intention to treat (ITT) and safety population: all patients who received at least one dose of study medication.|||Participants|||Number
2808186|NCT00463788|Secondary|Safety- Number of Participants Experiencing Any Adverse Event (AE)|Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.|Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010|Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab).|||participants|||Number
2808369|NCT00462709|Other Pre-specified|Complement C4 Serum Levels|Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=134).|||mg/dL||Standard Deviation|Mean
2808187|NCT00463788|Secondary|Time to Response (TTR)|The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.|Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.|||months||95% Confidence Interval|Median
2808188|NCT00463788|Secondary|Overall Survival (OS) Time|The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010|FAS population included all participants who were randomized as described in the pre-assignment details.|||months||95% Confidence Interval|Median
2808189|NCT00463788|Secondary|Progression-Free Survival (PFS) Time|The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.|||months||95% Confidence Interval|Median
2808190|NCT00463788|Primary|Best Overall Response (BOR)|Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.|||percentage of participants||95% Confidence Interval|Number
2808191|NCT00463684|Secondary|Number of Solicited Systemic Reactions: Days 4-7|Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.|4 days||||reactions|||Number
2808192|NCT00463684|Secondary|Number of Solicited Systemic Reactions: Days 0-3|Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.|3 days||||reactions|||Number
2808193|NCT00463684|Secondary|Number of Solicited Local Reactions to Measles Vaccine: Days 4-7|Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.|4 days||||reactions|||Number
2808194|NCT00463684|Secondary|Number of Solicited Local Reactions to Measles Vaccine: Days 0-3|Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.|3 days||||reactions|||Number
2808195|NCT00463684|Secondary|Number of Solicited Local Reactions to LJEV: Days 4-7|Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.|4 days||||reactions|||Number
2808196|NCT00463684|Secondary|Number of Solicited Local Reactions to LJEV: Days 0-3|Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.|3 days||||reactions|||Number
2808197|NCT00463684|Secondary|Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)|Subjects were monitored for immediate AEs and local reactions for 30 minutes after each injection by a study physician. Thereafter, parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days afterwards. Study staff called the subjects' parents 2 days after vaccination and monthly through 1 year to inquire about the child's well being and review the diary card. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. The subject returned to the vaccination clinic on Day 28, 6 months, and 1 year to be examined, have a blood draw, and review any AEs or serious adverse events (SAE) with parents.|1 year|Not all subjects were followed for a full 30 minutes after injection.|||Participants|||Count of Participants
2808198|NCT00463684|Secondary|Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)|"Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL, this table) and when including those with borderline results (≥150 mIU/mL)."|1 year|Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).|||titer||95% Confidence Interval|Geometric Mean
2808199|NCT00463684|Secondary|Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies|Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%.|1 year|Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).|||titer||95% Confidence Interval|Geometric Mean
2808200|NCT00463684|Primary|Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects|"Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL) and when including those with borderline results (≥150 mIU/mL, this table)."|1 year|Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).|||Participants|||Count of Participants
2808201|NCT00463684|Primary|Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition|"Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL, this table) and when including those with borderline results (≥150 mIU/mL)."|1 year|Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).|||Participants|||Count of Participants
2808202|NCT00463684|Primary|Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies|Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. Seropositivity was defined as a titer of ≥1:10.|1 year|Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).|||Participants|||Count of Participants
2808203|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)|The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808204|NCT00463606|Secondary|Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)|The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Inter-Quartile Range|Median
2808205|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)|The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808206|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808207|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808208|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808209|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808210|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)|The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808211|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
2808212|NCT00463580|Secondary|Change in Hamilton Depression Rating Scale 17 (HDRS-17) Scores Subgrouped by Baseline Hs-CRP.|The effects of baseline high-sensitivity C-reactive protein (hs-CRP) on reduction in depressive symptoms were investigated by examining the least squares mean change in the HDRS score from baseline to week 12 (infliximab minus placebo) among participants with baseline CRP of >1 mg/L, >3 mg/L, and >5 mg/L. A negative change score favors infliximab. The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.|Baseline, Week 12|This analysis includes all study participants in the first group then progressively limits participants in subsequent groups based on baseline hs-CRP concentrations.|||units on a scale||Standard Error|Least Squares Mean
2808213|NCT00463580|Secondary|Sleep Efficiency in High (CRP>5mg/L) Versus Low (CRP < or =5mg/L) Infliximab-treated Patients|Sleep efficiency is the percentage of time in bed spent sleeping (total sleep time/sleep period time x 100). A sleep efficiency of 80% or greater is considered normal. This outcome measure examines sleep efficiency between participants with high or low baseline CRP.|Baseline, Week 8|This analysis includes participants having complete polysomnography data at baseline and study week 8, who did not exhibit sleep apnea or {LMD, and who were treated with infliximab.|||percentage of time asleep||Standard Deviation|Mean
2808214|NCT00463580|Secondary|Sleep Efficiency|Sleep efficiency is the percentage of time in bed spent sleeping (total sleep time/sleep period time x 100). A sleep efficiency of 80% or greater is considered normal. This outcome measures examines sleep efficiency between study treatment groups.|Baseline, Week 8|This analysis includes participants having complete polysomnography data at baseline and study week 8, and who did not exhibit sleep apnea or periodic limb movement disorder (PLMD).|||percentage of time asleep||Standard Deviation|Mean
2808215|NCT00463580|Secondary|Plasma Concentrations of Tumor Necrosis Factor (TNF)-Alpha|This study collected blood samples to assess inflammatory markers. Tumor necrosis factor (TNF)-alpha values are invalid due to the administration of infliximab which interferes with the assay procedure.|Baseline, Week 12|TNF-alpha values were invalid due to the administration of infliximab interfering with processing TNF-alpha.||||||
2808216|NCT00463580|Secondary|Plasma Concentrations of CRP|This study collected blood samples to assess inflammatory markers. CRP increases when inflammation is present and can be measured with a high sensitivity-CRP (hs-CRP) test. Hs-CRP values <1 milligram per liter (mg/L) indicate low inflammation while values >10mg/L indicate inflammation.|Baseline, Week 12||||mg/L||Standard Deviation|Mean
2808217|NCT00463580|Secondary|Plasma Concentrations of Interleukin-6 (IL-6)|This study collected blood samples to assess inflammatory markers. IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, illness, and in patients with mood disorders. IL-6 is not present or is low in healthy individuals and exact reference ranges vary by lab, with an example normal reference range of 0.31 to 5.00 picograms per milliliter (pg/mL).|Baseline, Week 12||||pg/ml||Standard Deviation|Mean
2808218|NCT00463580|Secondary|Inventory of Depressive Symptomatology-Self-Report (IDS-SR) Scores|The Inventory of Depressive Symptomatology-Self-Report (IDS-SR) is a 30-item questionnaire asking respondents about symptoms of depression that they have experienced in the past 7 days. Each item is scored on a 4-point scale where 0 means that the symptom is absent and 3 means that the symptom is very strongly felt. Total scores can range between 0 and 84 and higher scores indicate more severe symptoms of depression.|Baseline, Weeks 1, 2, 4, 6, 8, 10 and 12||||units on a scale||Standard Deviation|Mean
2808412|NCT00462345|Secondary|Erythrocyte Sedimentation Rate (ESR)|The mean level of ESR (in mm/hr), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population|||mm/hr||Standard Deviation|Mean
2808219|NCT00463580|Secondary|Number of Remitted Patients During Treatment|The number of participants achieving depression remission are presented here. Depression remission is defined as an HDRS score of ≤7 or a Clinical Global Impression-Improvement (CGI-I) score of 1. The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression. The CGI-I scale includes a single item where a health care provider rates the participant's level of clinical improvement on a scale of 1 to 7 where 1 = very much improved since initiation of treatment and 7 = very much worse since initiation of treatment.|Week 12|All participants beginning the study are included in this analysis.|||participants|||Number
2808220|NCT00463580|Secondary|Number of Participants With a 50% Reduction in Hamilton Depression Rating Scale (HDRS) Scores|The number of participants with a 50% reduction in Hamilton Depression Rating Scale (HDRS) scores at any study point are presented here. The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.|Week 12|All participants beginning the study are included in this analysis.|||participants|||Number
2808221|NCT00463580|Primary|Hamilton Depression Rating Scale 17 (HDRS-17) Scores|The HDRS is a 17-item survey asking respondents to rate the degree of depressive symptoms they are feeling on a scale of 0 to 2-4, where 0 means the symptom is absent and 2-4 means the symptom is very strong. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.|Baseline, Weeks 1, 2, 4, 6, 8, 10 and 12|All participants beginning the study are included in this analysis.|||scores on a scale||Standard Deviation|Mean
2808222|NCT00463567|Other Pre-specified|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 14, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for AUC 1h-4h FEV1 at Day 14. Missing data were imputed using last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2808223|NCT00463567|Other Pre-specified|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 15, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for Trough FEV1 at Day 15. Missing data were imputed using last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
2808224|NCT00463567|Secondary|"The Percentage of Days of Poor Control Reported Over the 26 Week Treatment Period"|"A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of days of poor control as well as FEV1 reversibility components as covariates."|up to 26 weeks|Intent to Treat population consisting of all participants in Stage 2 of the study who received at least one dose of study drug. Eligible participants for the analysis were those with ≥7 evaluable diary days in the baseline period and ≥30% evaluable diary days (at least 20 days) in total.|||Percentage of days||Standard Error|Least Squares Mean
2808225|NCT00463567|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|after 12 weeks of treatment|Participants from the Intent to Treat Population of Stage 2 of the study who received at least one dose of study drug and for whom data was available for FEV1 at 12 weeks. Imputed with last observation carried forward.|||Liters||Standard Error|Least Squares Mean
2808226|NCT00463476|Post-Hoc|Number of Participants With Baseline Japanese Encephalitis (JE) Neutralizing Antibodies ≥ 10 Experiencing Fold-level Increases in JE Neutralizing Antibodies From Pre-vaccination to 28 Days Post-vaccination|Compares geometric mean titers (GMT) for baseline and 28 days post-vaccination among participants seropositive for neutralizing antibodies against JE virus (titer of ≥1:10) at Baseline. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%.|Baseline (Day 0) and 28 days post-vaccination|Per-protocol analysis set with baseline Japanese encephalitis (JE) neutralizing antibodies ≥ 10.|||Participants|||Count of Participants
2808238|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8.~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808227|NCT00463476|Secondary|Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination|"Parents recorded axillary temperature and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The participant was visited at home on Day 7 to review and collect the reactogenicity diary card.~Events were assessed by the clinician to quantify intensity using the following guidelines:~Mild: Events required minimal or no treatment and do not interfere with the child's functioning.~Moderate: Events resulted in a low level of concern with therapeutic measures. Moderate events may cause some interference with functioning.~Severe: Events interrupted the child's functioning and may have required systemic drug therapy or other treatment. Severe events are usually incapacitating."|7 days post-vaccination|All enrolled participants who received at least one dose of the live JE vaccine.|||Participants|||Count of Participants
2808228|NCT00463476|Secondary|Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination|"Parents recorded local reactions (redness, swelling, pain, and other local reactions) in a study diary.~Events were assessed by the clinician to quantify intensity using the following guidelines:~Mild: Events required minimal or no treatment and do not interfere with the child's functioning.~Moderate: Events resulted in a low level of concern with therapeutic measures. Moderate events may cause some interference with functioning.~Severe: Events interrupted the child's functioning and may have required systemic drug therapy or other treatment. Severe events are usually incapacitating."|3 days post-vaccination|All enrolled participants who received at least one dose of the live JE vaccine.|||Participants|||Count of Participants
2808229|NCT00463476|Secondary|Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)|Participants were monitored for immediate AEs and local reactions for 30 minutes after each injection by a study physician. Thereafter, parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days afterwards. Study staff called the participants' parents 2 days after vaccination and monthly through 1 year to inquire about the child's well being and review the diary card. The participant was visited at home on Day 7 to review and collect the reactogenicity diary card. The participant returned to the vaccination clinic on Day 28, 6 months, and 1 year to be examined, have a blood draw, and review any AEs or serious adverse events (SAE) with parents.|Day 0 and 28 days and 1 year post-vaccination|All enrolled participants who received at least one dose of the live JE vaccine. Not all participants were followed for a full 30 minutes after injection.|||Participants|||Count of Participants
2808230|NCT00463476|Secondary|Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies|Blood serum was collected immediately before administration (Day 0), Day 28, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%.|Day 0 and 28 days and 1 year post-vaccination|Per-protocol analysis set; 5 participants did not complete the 1-year post-vaccination visit.|||titer||95% Confidence Interval|Geometric Mean
2808231|NCT00463476|Primary|Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies|Blood serum was collected immediately before administration (Day 0), Day 28, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. Seropositivity was defined as a titer of ≥ 1:10.|Day 0 (pre-vaccination) and 28 days and 1 year post-vaccination|The per-protocol analysis set included all participants of the appropriate age at study entry (2 years of age ±3 months and 5 years of age ±3 months for each group respectively) who received LJEV at Day 0 and with valid serology laboratory results 28 days post-vaccination. Five participants did not complete the 1-year post-vaccination visit.|||percentage of participants||95% Confidence Interval|Number
2808232|NCT00463437|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808233|NCT00463437|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value|Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808234|NCT00463437|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value|Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808235|NCT00463437|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808236|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was ≥ 8.~The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808237|NCT00463437|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).~The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2820644|NCT00379808|Other Pre-specified|Interleukin 1 Receptor Antagonist (IL1ra)|IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)|1 month|all participants who completed the entire study|||pg/ml||Inter-Quartile Range|Median
2808239|NCT00463437|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||subjects|||Number
2808240|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the beginning of the study up to the end of the extended 6-month safety follow-up period||||subjects|||Number
2808241|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day (Day 0-30) period after the booster vaccination||||subjects|||Number
2808242|NCT00463437|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) period after the booster vaccination||||subjects|||Number
2808243|NCT00463437|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.|||subjects|||Number
2808244|NCT00463437|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.|||subjects|||Number
2808245|NCT00463437|Primary|Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)|Fever was measured as rectal temperature.|During the 4-day (Day 0-3) period after the booster vaccination|Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.|||subjects|||Number
2808246|NCT00463385|Secondary|Number of Participants With Adverse Events (AEs)|"A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above).~The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale:~Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death.~The Investigator determined the relationship between study drug and the occurrence of an AE as Not Related or Related (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa)."|From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).|Safety population (all treated patients).|||participants|||Number
2808247|NCT00463385|Secondary|Percentage of Participants With Clinical Response by Baseline JAK2 Assessment|Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline.|Up to 336 days|Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a positive or negative JAK2 result for each treatment group respectively.|||percentage of participants|||Number
2808248|NCT00463385|Secondary|Change From Baseline in Likert Abdominal Pain Scale|Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable.|Baseline and Cycle 6 (168 days)|Intent-to-treat patients with available data.|||units on a scale||Standard Deviation|Mean
2808249|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Non-Responders|Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with no clinical response and available hemoglobin values at each time point.|||g/dL||Full Range|Median
2808250|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Responders|Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with a clinical response and available hemoglobin values at each time point.|||g/dL||Full Range|Median
2808251|NCT00463385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores|"The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.~Physical Well-being consists of 7 questions, the subscale score ranges from 0-28;~Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28;~Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24;~Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28;~Anemia subscale consists of 20 questions, the subscale score ranges from 0-80;~Total FACT-An score ranges from 0-188."|Baseline and Cycle 6 (168 days).|Intent-to-treat patients with available data.|||units on a scale||Standard Deviation|Mean
2808297|NCT00463047|Secondary|Pain Relief Score (PR) at 10 Minutes|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2808252|NCT00463385|Secondary|Duration of First Clinical Response|"For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment.~For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement.~Kaplan-Meier methodology was used."|Up to 40 months|Intent-to-treat population with a clinical response.|||months||95% Confidence Interval|Median
2808253|NCT00463385|Secondary|Time to the First Clinical Response|"The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as:~Start date of the first clinical response - the first study drug date +1.~A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable."|Up to 168 days|Intent-to-treat population with a clinical response|||weeks||Full Range|Median
2808254|NCT00463385|Secondary|Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment|"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 336 days|Intent-to-treat (ITT), defined as as all patients who were randomized, independent of whether they received study treatment or not.|||percentage of participants||95% Confidence Interval|Number
2808255|NCT00463385|Primary|Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment|"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 168 days|Modified intent-to-treat (MITT), defined as the patients who had a confirmed diagnosis of Myelofibrosis with myeloid metaplasia (MMM), received at least one dose of study drug, and participated in the study for at least 56 days.|||percentage of participants||95% Confidence Interval|Number
2808256|NCT00463346|Primary|Psychotic Symptoms - Measured Using the PANSS|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.|12 weeks||||units on a scale||Standard Error|Mean
2808257|NCT00463346|Primary|Number of Drinking Days||12 weeks||||days||Standard Deviation|Mean
2808258|NCT00463229|Secondary|Kessler - 10|The Kessler-10 assesses level of anxiety and depressive symptoms a person may have experienced in the most recent four-week period. Its main strength is a superior ability to screen for anxiety and affective disorders. Each item is assigned a score ranging from 5 (all of the time) to 1 (none of the time). These 10 items are summed to give scores ranging from 10-50, where 50 indicates high risk of anxiety or depressive disorder. Previous studies have established a cut-off score of 16-29/50 for medium risk, and 30-50/50 as high risk for anxiety and depressive disorders.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
2808259|NCT00463229|Secondary|Personal Resource Questionnaire (PRQ85-Part Two)|The PRQ85-Part Two is a 25-item scale that measures perceived social support along five dimensions: provision for attachment/intimacy; social integration; opportunity for nurturing behaviour; reassurance of worth as an individual and in role accomplishments; and the availability of informational, emotional, and material help. Scores range from a minimum of 25 to maximum score of 175; a higher score indicates a greater perception of social support.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
2808260|NCT00463229|Secondary|Centre for Epidemiological Studies in Depression Scale (CES-D)|The CES-D scale is a 20-item, self-reported questionnaire that assesses the current frequency of depressive symptoms. Total scores can range from 0 to 60; the higher the score, the more depressed. Values were determined by taking the value of the 12-month data (Timepoint 2) and subtracting them from the baseline data (Timepoint 1).|Baseline and 12 months|Timepoint 2 minus Timepoint 1|||units on a scale||Standard Deviation|Mean
2808261|NCT00463229|Secondary|Short Portable Mental Status Questionnaire.|The 10-item Short Portable Mental Status Questionnaire (SPMSQ) is used for the screening, diagnosis and assessment of cognition. The SPMSQ is short, easily administered and has been designed, tested, standardized and validated in a variety of populations, including stroke. The SPMSQ consists of 10 items. The individual items sum to provide a total score, ranging from 0-10; with greater than 4 errors indicating some degree of intellectual impairment. The higher the score, the less impairment.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
2808262|NCT00463229|Secondary|Reintegration to Normal Living Index|"The RNLI assesses global functional status and measures both the stroke survivors' perceptions of their own capabilities and objective indicators of physical, social, and psychological performance. The RNLI consists of 11 items which cover the domains of mobility, self-care abilities, daily activities, recreational and social activities, family roles, and personal relationships, presentation of self and general coping skills. Each item is scored as 0 to 2. Minimum score is 0 and maximum score is 22. The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration."|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
2808263|NCT00463229|Secondary|Stroke Impact Scale - 16|The SIS-16 assesses several aspects of health-related quality of life that are important to stroke survivors, caregivers, and healthcare professionals. The SIS-16 consists of 16 items which cover the physical aspects of stroke including: strength, hand function, mobility, and activities of daily living/instrumental activities of daily living. Each item is assigned a score ranging from 1 (could not do at all) to 5 (not difficult at all). The individual items sum to provide a total score (range from 16 to 80), with higher scores indicating higher levels of health-related quality of life and function.|Baseline (pre-randomization) and 12 months||||units on a scale||Standard Deviation|Mean
2808264|NCT00463229|Primary|Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function|The primary measure of effect was the change in health-related quality of life and functioning from baseline to 12-months as measured by the SF-36 physical functioning score. The range of possible scores for this subscale is 0-100, with a higher score indicating a more favourable health status.|Baseline (pre-randomization) and 12 months||||Units on a scale||Standard Deviation|Mean
2808265|NCT00463060|Secondary|Number of Participants According Failure and Survival||4 years||||Participants|||Count of Participants
2808266|NCT00463060|Secondary|Quality of Life||4-6 weeks after radiation therapy|data not collected||||||
2808267|NCT00463060|Secondary|Percentage of Patients With Distant Control|Distant control defined as distant metastasis contained outside of the radiation field within months of treatment.|4 weeks||||percentage of participants||95% Confidence Interval|Number
2808268|NCT00463060|Secondary|Percentage of Patients With Local Control|Local control was defined as a tumor volume equal to or less than the tumor volume at start of radiotherapy.|4 years|the 4-year estimates for local control|||percentage of participants||95% Confidence Interval|Number
2808269|NCT00463060|Secondary|Percentage of Patients With Toxicity Grade 3 or Higher|% of patients experienced one or more grade ≥ 3 toxicities. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4),and death (Grade 5).|5 years||||Participants|||Count of Participants
2808270|NCT00463060|Primary|Number of Participants With Particular Disease Status|Number of participants who have no evidence of disease and number of participants with distant metastases.|5 years|Phase 2 only|||participants|||Number
2808271|NCT00463060|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|Sunitinib (SU) and radiation (IGRT) doses were sequentially escalated using a ping-pong strategy according to a 3 + 3 design phase 1 study. The starting dose was sunitinib 25 mg and IGRT 40 Gy. MTD reflects the highest dose that did not cause a dose limiting toxicity. Toxicity was in assessed in patients at regular intervals by using the Common Terminology Criteria for Adverse Events criteria (version 3.0). Dose limiting events were defined as any grade 4 or 5 toxicity and unexpected grade 3 toxicity. Expected grade 3 toxicities from radiation include mucositis or esophagitis lasting ≤7 days. Grade 3 metabolic and hematologic toxicities are considered expected events with sunitinib and therefore were not considered DLTs|2 years||||Participants|||Count of Participants
2808272|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented.|Endpoint (End of second double-blind treatment period or last observation after start of treatment period)|Double-blind safety analysis set: 88 subjects who received FBT and 94 subjects who received Oxycodone at any time during the double-blind treatment period who completed the PFTS questionnaire|||Participants|||Number
2808273|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented.|At the end of the second double-blind treatment period (Visit 6)|Double-blind safety analysis set: 83 subjects who received FBT and 87 subjects who received Oxycodone in the second double-blind period|||Participants|||Number
2808274|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented.|The end of the first double-blind treatment period.|Double-blind safety analysis set: 88 subjects who received FBT and 90 subjects who received Oxycodone in the first double-blind period|||Participants|||Number
2808413|NCT00462345|Secondary|C-reactive Protein (CRP) Level|The mean level of CRP in milligrams per liter (mg/L), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population|||mg/L||Standard Deviation|Mean
2808275|NCT00463047|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|After completion of both double-blind treatment periods or early termination|Double-blind safety analysis set: 190 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment|||Participants|||Number
2808276|NCT00463047|Secondary|Medication Performance Assessment 60 Minutes After-treatment|"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded."|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Number of episodes treated|Participants||Number
2808277|NCT00463047|Secondary|Medication Performance Assessment 30 Minutes After-treatment|"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded."|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Number of episodes treated|Participants||Number
2808278|NCT00463047|Secondary|Standard Rescue Medication Usage|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|During the administration of study drug during the double blind treatment periods.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Number of episodes treated|Participants||Number
2808279|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808280|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808281|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808322|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment|||treatment cycles||Full Range|Median
2808282|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808283|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808284|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes|Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to meaningful pain relief fell into that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808285|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=60 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808286|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=45 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808287|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=30 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808288|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=15 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2817677|NCT00399542|Secondary|Month 2 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2808289|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=10 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808290|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes|Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared.|From time was administered to 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Number of episodes treated|Participants||Number
2808291|NCT00463047|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) times 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Percent change in units on a scale||Standard Deviation|Mean
2808292|NCT00463047|Secondary|Total Pain Relief (TOTPAR60) at 60 Minutes|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808293|NCT00463047|Secondary|Pain Relief Score (PR) at 60 Minutes|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2808294|NCT00463047|Secondary|Pain Relief Score (PR) at 45 Minutes|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2808295|NCT00463047|Secondary|Pain Relief Score (PR) at 30 Minutes|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2808296|NCT00463047|Secondary|Pain Relief Score (PR) at 15 Minutes|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2808332|NCT00462917|Primary|Beck Anxiety Inventory (BAI)|A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."|||score on a scale||Standard Deviation|Mean
2808298|NCT00463047|Secondary|Pain Relief (PR) Score at 5 Minutes|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|Five minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
2808299|NCT00463047|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808300|NCT00463047|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808301|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100.|Immediately before and 60 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
2808302|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on scale||Standard Error|Mean
2808303|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100.|Immediately before and 30 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
2808304|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100.|Immediately before and 15 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
2808305|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change in units on a scale||Standard Error|Mean
2808306|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100.|Immediately before and 5 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percent change in units on a scale||Standard Error|Mean
2808307|NCT00463047|Secondary|Pain Intensity Difference (PID 60) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 60 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808308|NCT00463047|Secondary|Pain Intensity Difference (PID 45) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808309|NCT00463047|Secondary|Pain Intensity Difference (PID 30) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808310|NCT00463047|Secondary|Pain Intensity Difference (PID 10) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808320|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat population.|||months||95% Confidence Interval|Median
2808311|NCT00463047|Secondary|Pain Intensity Difference (PID 5) at 5 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 5 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808312|NCT00463047|Primary|Pain Intensity Difference (PID15) At 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and fifteen minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
2808313|NCT00462982|Primary|Central Nervous System (CNS) Response Rate by RECIST Criteria|Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.|up to a year||||participants|||Number
2808314|NCT00462943|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
2808315|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
2808316|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response|||months||Full Range|Median
2808317|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response|||months||Full Range|Median
2808318|NCT00462943|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.~Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 4 years|Intent to treat|||participants|||Number
2808319|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|Day 1 up to Month 9|Intent to treat population.|||months||95% Confidence Interval|Median
2808323|NCT00462943|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL|||percentage of participants||95% Confidence Interval|Number
2808324|NCT00462943|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).~Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed)."|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline|||percentage of participants|||Number
2808325|NCT00462943|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)~Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.~Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.~Partial Response - CHR plus one or more of the following:~Persistence of splenomegaly with a reduction of ≥50% from pre-treatment~Platelets > 450*10^9/L~Presence of immature cells in the peripheral blood~5% to 25% blasts in the bone marrow~If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat|||percentage of participants|||Number
2808326|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
2808327|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
2808328|NCT00462943|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:~Complete: 0% Ph+ cells~Partial: >0%-35% Ph+ cells~Minor: >35%-65% Ph+ cells~Minimal: >65%-95% Ph+ cells~No Response: >95% Ph+ cells~Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat|||percentage of participants|||Number
2808329|NCT00462943|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 9 months|Intent to treat population|||percentage of participants||95% Confidence Interval|Number
2808330|NCT00462943|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population|||percentage of participants||95% Confidence Interval|Number
2808331|NCT00462917|Secondary|Impact of Events Scale (IES)|A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."|||score on a scale||Standard Deviation|Mean
2808333|NCT00462917|Primary|Center for Epidemiological Studies-Depression Scale (CES-D)|A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.|6 weeks, 6 months, and 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."|||score on a scale||Standard Deviation|Mean
2808334|NCT00462904|Secondary|Safety Parameters|Routine physiologic and laboratory parameters will be followed for 28 days post infusion. These will include vital signs, cardiac enzymes, renal and hepatic function.|28 days|This study was terminated early by the sponsor. Ownership of the company changed, and there was no longer a desire to continue the trial; therefore, no analysis was performed. No data was collected.||||||
2808335|NCT00462904|Primary|Plasma Levels of BPI|pharmacokinetic data over the 48 hour infusion period will be obtained as well as 24 hours post infusion.|48 hours of infusion and 24 hours post infusion|This study was terminated early by the sponsor. Ownership of the company changed, and there was no longer a desire to continue the trial; therefore, no analysis was performed. No data was collected.||||||
2808336|NCT00462865|Secondary|Number of Participants With Recurrent Disease||6 months and again at the end of the study (1 year)||||Participants|||Count of Participants
2808337|NCT00462865|Primary|Toxicity Related to Treatment|6 out of 17 patients came off study for toxicity prior to receiving all treatment. Toxicity issues of administering 6 cycles of gemcitabine, capecitabine, and Avastin and one year of consolidation of Avastin in women with breast cancer previously treated with neoadjuvant chemotherapy that lead to patients being taken off study.|1 year||||participants|||Number
2808338|NCT00462839|Secondary|Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.||1 hour||||participants|||Number
2808339|NCT00462839|Secondary|Level of Training||1 hour||||participants|||Number
2808340|NCT00462839|Secondary|Number and Type of Care Providers Assigned to Study Arms.||1 hour|per protocol|||participants|||Number
2808341|NCT00462839|Primary|Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.|Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.|1 hour|per protocal|||milliliters||95% Confidence Interval|Mean
2808342|NCT00462826|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and evaluable patients|||months||90% Confidence Interval|Median
2808343|NCT00462826|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.|Eligible and evaluable patients|||months||90% Confidence Interval|Median
2808344|NCT00462826|Primary|Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Adverse events at least possibly related to the study agent.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and evaluable patients.|||Participants|||Count of Participants
2808345|NCT00462826|Primary|Objective Tumor Response (RECIST 1.0)|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.|Eligible and evaluable patients|||participants|||Number
2808346|NCT00462826|Primary|6 Month Progression-free Survival|Number of participants who survived progression-free for more than 6 months.|At 6 monthsEvery other cycle during treatment for the first 6 months.||||participants|||Number
2808347|NCT00462761|Secondary|Summary of Hematologic Improvement Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia|"Hematologic improvement is summarized in terms of Erythroid Response (HI-E), Platelet Response (HI-P), Neutrophil Response (HI-N), and Hematologic Improvement (HI).~For post-treatment results, HI-E major responders had >2 g/dL increase in hemoglobin for at least 1 result after first treatment and transfusion independent; minor responders 1 to 2 g/dL increase in hemoglobin for at least 1 result post first treatment and a 50% decrease in red blood cell transfusion requirements. For HI-P, major responders had ≥30 × 10^9/L increase in platelet count and transfusion independent; minor responders had 50% or more increase in platelet count with a net increase between 10 to 30 × 10^9/L and 50% decrease in platelet transfusion requirements. For HI-N, major responders had an increase in absolute neutrophil count (ANC) of 100% or an absolute increase of more than 0.5 × 10^9/L (whichever is greater); minor responders had an increase in ANC of 100% but an absolute increase of <0.5 × 10^9/L."|Baseline up to 28 days after the last dose, up to approximately 3 years|Hematologic improvement was assessed in the Intent-to-Treat Population.|||Participants|||Count of Participants
2808348|NCT00462761|Secondary|Calculated Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia|Complete Response (CR) response criteria included either a post-baseline bone marrow biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L on the same date as the qualifying bone marrow assessment. CRp response included all CR criteria met except participant did not experience a platelet recovery. Participants must have experienced an ANC Recovery. CRi response included a qualifying bone marrow result, but did not experience an ANC recovery. Participants may or may not have experienced a platelet recovery and were not required to be transfusion independent. Partial remission (PR) response included a decrease of ≥50% in % blasts in the bone marrow aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Nonresponders (NR) had a pre- and 1 or more post-baseline bone marrow assessment carried out, but results did not meet any of the CR or PR or progressive disease criteria.|Baseline up to 28 days after the last dose, up to approximately 3 years|Disease response was assessed in the Evaluable Population.|||Participants|||Count of Participants
2808349|NCT00462761|Secondary|Calculated Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia|Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression.|Baseline up to 28 days after the last dose, up to approximately 3 years|Disease response was assessed in the Evaluable Population.|||Participants|||Count of Participants
2808350|NCT00462761|Secondary|Calculated Best Disease Response by Dose Cohort in Terms of Best Overall Response Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia|Complete Response (CR) response criteria included either a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L on the same date as the qualifying BM assessment. CRp response included all CR criteria met, except participant did not experience a platelet recovery (ANC recovery required). CRi response included a qualifying BM result, but not an ANC recovery. Participants may or may not have had a platelet recovery and were not required to be transfusion independent. Partial remission (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline to a post-baseline result between 5% to 25% in the bone marrow aspirate or biopsy. Nonresponders (NR) had a pre- and 1 or more post-baseline BM assessment carried out, but results did not meet any response criteria. Participants who were not evaluable (NE) did not have at least 14 days of treatment and were not assessed.|Baseline up to 28 days after the last dose, up to approximately 3 years|Disease response was assessed in the Intent-to-Treat Population.|||Participants|||Count of Participants
2808351|NCT00462761|Secondary|Calculated Best Disease Response by Dose Cohort in Terms of Progressive Disease Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia|Progressive disease response criteria included doubling of blast count % in bone marrow (biopsy or aspirate) from baseline; considering measurements starting on Study Day 15, doubling of blast count % in blood from baseline; death determined to be related to disease or disease progression; and investigator reported disease progression.|Baseline up to 28 days after the last dose, up to approximately 3 years|Disease response was assessed in the Intent-to-Treat Population.|||Participants|||Count of Participants
2808352|NCT00462761|Primary|Summary of Treatment-emergent Treatment-related Grade 3 or 4 Adverse Events By At Least 10% of All Participants By Dose Group Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia||Baseline up to 30 days post last dose|Safety events were assessed in the Safety Population.|||Participants|||Count of Participants
2808353|NCT00462761|Primary|Summary of Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia||Baseline up to 30 days post last dose|Safety events were assessed in the Safety Population.|||Participants|||Count of Participants
2808354|NCT00462748|Primary|Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End|Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.|6 Weeks|"The Full Analysis Set (FAS) all patients who were:~Randomised~Took at least one dose of double-blind medication~Had a baseline measurement of efficacy~Had a post-baseline measurement of efficacy~Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received"|||Percent|||Number
2808355|NCT00462735|Secondary|Distant Metastases|Percentage of participants who did not have distant control|2 years||||percentage of participants|||Number
2808356|NCT00462735|Secondary|UW-QOLR: Quality of Life Score|University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).|2 years|Twenty patients completed the UW-QOLR questionnaire before and after therapy.|||units on a scale||Full Range|Mean
2808357|NCT00462735|Secondary|Long- Term Toxicity|Grade 3 toxicities events|2 years||||events|||Number
2808358|NCT00462735|Primary|Survival|Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology|2 years||||percentage of participants|||Number
2808359|NCT00462735|Primary|Llocoregional Recurrence|Percentage of Participants with Loco-regional recurrence.|2 years||||Participants|||Count of Participants
2808360|NCT00462722|Secondary|Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown||Baseline and after 9 months of training|Because of the costs associated with gene and protein expression techniques and data reduction, we did not pursue this secondary outcome after learning the results of the primary outcome (change in fat-free mass).||||||
2817678|NCT00399542|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2808370|NCT00462709|Other Pre-specified|Functional C1INH Serum Levels|"Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=132).|||percent||Standard Deviation|Mean
2808371|NCT00462709|Other Pre-specified|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=137).|||mg/dL||Standard Deviation|Mean
2808372|NCT00462709|Primary|Frequency of All HAE Attacks|A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.|Duration of the study|Intent-to-treat Efficacy (ITT-E) Population (N=146; the number of subjects who received at least one prophylactic dose of C1INH-nf for the prevention of HAE attacks). HAE attack frequency was reported by 137 subjects at screening (i.e., data were missing for 9 subjects).|||attacks per month||Full Range|Median
2808373|NCT00462670|Secondary|Body Weight (Percent Change)|Percent change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration||||percentage of body weight (Kg)||Standard Deviation|Mean
2808374|NCT00462670|Primary|Body Weight (Amount of Change)|Change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration||||Kg||Standard Deviation|Mean
2808375|NCT00462644|Secondary|Number of Deaths|deaths|death in hospital||||participants|||Number
2808376|NCT00462644|Primary|Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)||60 minutes after administration of cotrosyn||||micrograms/dL||Standard Deviation|Mean
2808377|NCT00462644|Primary|Change in Baseline Cortisol|change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)|4-6hr after RSI||||micrograms/dL||Standard Deviation|Mean
2808378|NCT00462644|Primary|Postintubation Cortisol (Baseline Cortisol Level)|cortisol level after randomization and rapid sequence induction|postintubation (baseline cortisol level)||||micrograms/dL||Standard Deviation|Mean
2808379|NCT00462644|Secondary|Ventilator Days||time from intubation to extubation||||days||Standard Deviation|Mean
2808380|NCT00462644|Secondary|Intensive Care Unit (ICU) Length of Stay|ICU length of stay in days|time from hospital admission to transfer out of ICU to floor bed||||days||Standard Deviation|Mean
2808381|NCT00462644|Secondary|Hospital Length of Stay|days from admission to hospital discharge|time to hospital discharge in days||||days||Standard Deviation|Mean
2808382|NCT00462644|Primary|Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test||pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test|||||||
2808383|NCT00462605|Secondary|Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, the research assay was not done.||||||
2808384|NCT00462605|Secondary|Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH)||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, the research assay was not done.||||||
2808385|NCT00462605|Secondary|Clinical Activity Assessed by Change in Transfusion Requirements||Baseline and after 2 cycles|Due to the limited number of clinical responders, this outcome was not measured.||||||
2808386|NCT00462605|Secondary|Clinical Activity Assessed by Change in Peripheral Blood Counts||Baseline and after 2 cycles||||cell/mm^3||Standard Error|Mean
2808387|NCT00462605|Primary|Response (Complete and Partial Response) in Patients With Myeloid Disorders|Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.|Up to 2 years||||Participants|||Count of Participants
2808388|NCT00462501|Primary|Complete Pathologic Response|This will be assessed on the basis of the surgical pathology report.|3 years||||participants|||Number
2808389|NCT00462462|Secondary|Patient Benefit||study end|||||||
2808390|NCT00462462|Secondary|Change in Volume of Congenital Venous Malformation (CVM) From Screening to Study End (Day 112 Visit).||Screening and study end (Day 112)||||cm3||Standard Deviation|Mean
2808391|NCT00462462|Secondary|Systemic (Cardiopulmonary, Hematological, Metabolic) and Local Outcome of the Two Test Products.||Study end|||||||
2808392|NCT00462462|Primary|Systemic Exposure to Ethanol With the Two Test Products: Determination of the Maximum Plasma Concentration (Cmax)|Blood samples were performed, just before infusion, then 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, and 120 min after infusion at the first site, then every 60 min onwards until ethanol levels are found under the detection limit. Cmax was estimated directly from experimental data. If all the ethanol concentrations of a patient was below the limit of quantification of the laboratory (LOQ), Cmax was reported as LOQ/2 for this patient.|Baseline visit (just before and during test product infusion procedure)||||g/L||Full Range|Mean
2808393|NCT00462449|Secondary|Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)|upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol|||units on a scale||95% Confidence Interval|Mean
2808394|NCT00462449|Secondary|Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)|Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)|12 weeks|Per protocol.|||units on a scale||95% Confidence Interval|Mean
2808395|NCT00462449|Primary|Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)|upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol. Number was determined based on the number of participants enrolled and eligible.|||units on a scale||95% Confidence Interval|Mean
2808396|NCT00462423|Secondary|Safety and Tolerability of This Combination|See adverse events Table|April 2007 through December 2010|||||||
2817679|NCT00399542|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2808397|NCT00462423|Secondary|Objective Response Rate (RR) in Patients With Measurable Lesions Time to Objective Response|The objective response rate is defined as the percentage of patients showing complete or partial response.|The median duration of follow-up for surviving patients was 41.6 months.||||Percentage of participants||95% Confidence Interval|Number
2808398|NCT00462423|Secondary|Overall Survival (OS)|The duration of overall survival was defined as the number of months between the start date of protocol treatment and the date of death (irrespective of cause), and was right-censored at the date of last contact for patients who were alive as of the data cutoff.|April 2007 through December 2010||||months||95% Confidence Interval|Median
2808399|NCT00462423|Secondary|Progression-free Survival|Median time of progression-free survival from first treatment according to RECIST 1.0|From start of treatment to disease progressin; median duration of follow-up for surviving patients was 41.6 months.||||Months||95% Confidence Interval|Median
2808400|NCT00462423|Primary|Progression-free Survival (PFS) at 4 Months|Progression-free survival at 4 months from first treatment as determined by RECIST 1.0|4 months.||||percentage of patients||95% Confidence Interval|Number
2808401|NCT00462384|Secondary|Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.|EEP (Weeks 29 to 36)|ITT population|||days||Standard Deviation|Mean
2808402|NCT00462384|Secondary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.|EEP (Weeks 29 to 36)|ITT population|||percentage of participants|||Number
2808403|NCT00462384|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.|EEP (Weeks 29 to 36)|ITT population|||percentage of participants|||Number
2808404|NCT00462384|Secondary|Time to Achievement of Response|Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.|Baseline to Week 40|ITT population|||days||Standard Deviation|Mean
2808405|NCT00462384|Primary|Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)|The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.|Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)|Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2808406|NCT00462345|Secondary|Modified Sharp Radiographic Joint Space Narrowing Score (JSN)|JSN Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total scores for JSN in the hands was 100 and in the feet was 48, for a maximum overall score of 148. Total JSN was for both hands and feet.|Screening, Weeks 24 and 48|ITT population. 39 participants were analyzed for this outcome measure.|||scores on a scale||Standard Deviation|Mean
2808407|NCT00462345|Secondary|Modified Sharp Radiographic Erosion Score (ES)|Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Maximum total erosion score in the hands was 100 and in the feet was 42, for a maximum overall score of 142. Total erosion score was for both hands and feet.|Screening, Weeks 24 and 48|ITT population|||scores on a scale||Standard Deviation|Mean
2808408|NCT00462345|Secondary|Modified Total Sharp-Genant Score (mTSS)|Posterior-anterior (PA) radiograph of each hand and anterior-posterior (AP) radiograph of each foot were taken separately and assessed according to Genant's method as modified from Sharp's method. The Sharp-Genant score=total of the erosion score and the joint space narrowing (JSN) score of all the hands and feet. Erosion Score: 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. JSN Score:13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total erosion score in hands=100 and in feet=42; maximum scores for JSN in the hands=100 and in feet=48. Maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. Change in scores was calculated as change=final score minus initial score.|Screening and Weeks 24 and 48|ITT population|||scores on a scale||Standard Deviation|Mean
2808409|NCT00462345|Secondary|SF-36 Mental Component Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2808410|NCT00462345|Secondary|Physical Function as Assessed by Short Form 36 (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
2808411|NCT00462345|Secondary|HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 24 and 48|ITT population|||scores on a scale||Standard Deviation|Mean
2808414|NCT00462345|Secondary|Patient Assessment of Pain (VAS)|"The mean score of pain at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100-mm horizontal VAS, where the left endpoint indicated No pain, and the right endpoint indicated Unbearable pain. A negative change indicated improvement."|Baseline, Weeks 24 and 48|ITT population|||mm||Standard Deviation|Mean
2808415|NCT00462345|Secondary|Physician Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of RA at Week 0 and the change from Week 0 (baseline) to Weeks 24 and 48 as assessed by investigators using a 100-mm horizontal VAS, where the left endpoint indicated No disease activity (no symptom, or no symptom of RA), and the right endpoint indicated Maximum disease activity (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population|||mm||Standard Deviation|Mean
2808416|NCT00462345|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of rheumatoid arthritis (RA) at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100 mm horizontal VAS, where the left endpoint indicated No disease activity (no symptom, or no symptom of RA), and the right endpoint indicated Maximum disease activity (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population|||mm||Standard Deviation|Mean
2808417|NCT00462345|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examination of 68 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of tender joints was recorded on the joint assessment form at each visit as either tender or not tender.|Baseline, Weeks 24 and 48|ITT population|||tender joints||Standard Deviation|Mean
2808418|NCT00462345|Secondary|Swollen Join Count (SJC)|Number of swollen joints was determined by examination of 66 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit as swollen or not swollen.|Baseline, Weeks 24 and 48|ITT population|||swollen joints||Standard Deviation|Mean
2808419|NCT00462345|Secondary|Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24|"The percentage of participants categorized as good, moderate, or nonresponders according to the EULAR response criteria at Week 24. Participants were categorized as good responders if the intensity of their symptoms was in the low disease activity (DAS28 less than [<]3.2) category after treatment, and their symptoms significantly decreased to >1.2. Participants were categorized as moderate responders if the intensity of their symptoms was in the moderate or high disease activity (DAS28 >3.2) category after treatment, and the symptoms significantly decreased to >1.2; or if the intensity of their symptoms was in the low or moderate disease activity (DAS28 <5.1) category, and the DAS28 score changed more than 0.6 or 1.2 or less. Participants were categorized as non-responders if they did not fall into the good or moderate categories."|Week 24|ITT population|||percentage of participants|||Number
2808420|NCT00462345|Secondary|Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity.|Baseline, Week 24|ITT population|||percentage of participants|||Number
2808421|NCT00462345|Secondary|Disease Activity Score Based on 28-Joint Count (DAS-28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hr]) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT population|||scores on a scale||Standard Deviation|Mean
2808422|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24|ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2808423|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24|ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2808424|NCT00462345|Primary|Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24|ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2808425|NCT00462332|Secondary|Disease-free Survival||At 2 years from study entry|||||||
2808426|NCT00462332|Secondary|Event-free Survival||At 2 years from study entry|||||||
2808427|NCT00462332|Secondary|Length of Survival||At 2 years and a half from study entry||||years||Standard Deviation|Mean
2808428|NCT00462332|Secondary|Toxicity|Number of AEs and SAEs|At 2 years from study entry|||||||
2808429|NCT00462332|Primary|Number of Patients With Complete Response|"Normal clinical or X-ray examination (lymph nodes, liver, spleen)~No symptoms~Lymphocytes higher or equal to 4.0 per 10^9/L~Neutrophils lower or equal to 1.5 per 10^9/L~Platelets >100 per 10^9/L~Hb >11.0 g/dL~Bone marrow lymphs according to age, lymphocytes <30%, no nodules."|At 2 years from study entry||||participants|||Number
2808583|NCT00461591|Secondary|Time to Progression|The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2808430|NCT00462306|Secondary|Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires|Number of subjects with obstetrician diagnosis of pregnancy induced hypertension (pre-eclampsia) among subjects with a positive compared to a negative Berlin questionnaire. The Berlin Questionnaire consists of three categories. Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a Positive Berlin Questionnaire if 2 or more categories are positive.|1-2minutes|Analysis per protocol|||participants|||Number
2808431|NCT00462306|Primary|Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing|The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.|1-2 minutes|Pregnant Women presenting to Prentice Women's Hospital or non-pregnant women or childbearing age presenting for ambulatory surgery from 10/2005 to 9/2007 were selected randomly and asked to complete the survey.|||participants|||Number
2808432|NCT00462280|Secondary|At Least 1 Study-related Adverse Event Reported During the Study|All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.|Baseline up to 26 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm."|||participants|||Number
2808433|NCT00462280|Secondary|Change in C-reactive Protein (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
2808434|NCT00462280|Secondary|Change in CPK (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||U/L||95% Confidence Interval|Mean
2808435|NCT00462280|Secondary|Change in SGOT/ALT (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||U/L||95% Confidence Interval|Mean
2808436|NCT00462280|Secondary|Change in SGOT/AST (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||U/L||95% Confidence Interval|Mean
2808437|NCT00462280|Secondary|Change in Triglycerides (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
2808438|NCT00462280|Secondary|Change in HDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
2808439|NCT00462280|Secondary|Change in LDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
2808440|NCT00462280|Secondary|Change in Cholesterol (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||mg/dL||95% Confidence Interval|Mean
2808441|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808442|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2812344|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|3 month||||times per week||Standard Deviation|Mean
2808443|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808444|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808445|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808446|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808447|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808448|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808449|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808450|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808451|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808452|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808453|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|||score||Standard Deviation|Mean
2808454|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808455|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||percentage of cells that are positive||95% Confidence Interval|Mean
2808456|NCT00462280|Secondary|Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations|Assessed by photos of subjects' back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||pairs of photos|||Number
2808457|NCT00462280|Secondary|Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations|From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."|||score||Standard Deviation|Mean
2808458|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|||score||Standard Deviation|Mean
2808459|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.|SDMT Oral Score: SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT oral scores.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
2808460|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.|SDMT Written Scores. SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT written scores.|baseline, 6 weeks, 12 weeks|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
2808469|NCT00462072|Primary|Psoriasis Area and Severity Index (PASI) Delta|The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg|||Index Delta||Standard Deviation|Mean
2808461|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.|"BVMT-R Delayed recall. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations.~After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.~These scores are for the delayed recall raw score which ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
2808462|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.|"BVMT-R total recall score. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations. The total recall score is the sum of the three learning trials.~After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.~These scores are for the total recall raw score which ranges from 0-36 with 36 being the highest and best possible score."|Baseline, 6 weeks, 12 weeks after beginning Namenda or placebo|All subjects who completed the study.|||units on a scale||Standard Deviation|Mean
2808463|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.|Trail Making Test Part B consists of 24 circles on a piece of paper, but rather than all of the circles containing numbers, half of the circles have the numbers 1-12 in them and the other half (12) contain the letters A-L. The person taking the test has the more difficult task of drawing a line from one circle to the next in ascending order; however, he must alternate the circles with numbers in them (1-13) with circles with letters in them (A-L). In other words, he is to connect the circles in order like this: 1-A-2-B-3-C-4-D-5-E and so on. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||seconds||Standard Deviation|Mean
2808464|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.|Trail Making Test Part A consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in the circles. The test taker's task is to start with number one and draw a line from that circle to the circle with the number two in it to the circle with the three in it, etc. The person continues to connect the circles in numerical order until they reach number 25. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part A. This is a timed test and the number of seconds to complete the task is recorded.|baseline, 6 weeks, 12 weeks||||seconds||Standard Deviation|Mean
2808465|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.~The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall raw score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.~These scores are for the delayed recall learning raw score. The HVLT-R delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
2808466|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.~The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.~These results are for the HVLT-R total recall raw learning score. The HVLT-R total recall raw learning score ranges from 0 to 36 with 36 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.|||units on a scale||Standard Deviation|Mean
2808467|NCT00462124|Secondary|Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum|The space between the prostate and the rectum will be determined by Ct in subjects with prostate cancer who underwent radiotherapy and who received the balloon. The degree of increase in this space is directly related to a reduction of isodose level delivered to the rectum, and therefore a reduction in post radiation therapy rectal adverse event sequela.|6 months|ITT|||Participants|||Count of Participants
2808468|NCT00462124|Primary|Safety of Balloon Implant|Assessed by collecting number of subjects experiencing a serious device related adverse event.|6 months|ITT|||Participants|||Number
2808551|NCT00461734|Primary|Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).||At 2-year follow-up|Per Protocol Cohort with data available|||percentage||Standard Deviation|Mean
2808552|NCT00461734|Primary|Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).||At 2-year follow-up|Intent to Treat Cohort with data available|||percentage||Standard Deviation|Mean
2808470|NCT00462072|Primary|Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg|||Index||Standard Deviation|Mean
2808471|NCT00462072|Primary|Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.|Baseline (Wk 0)|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg|||Index||Standard Deviation|Mean
2808472|NCT00462072|Primary|Disease Activity Score (DAS28) Delta|The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]|||Score Delta||Standard Deviation|Mean
2808473|NCT00462072|Primary|Week 10 Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]|||Score||Standard Deviation|Mean
2808474|NCT00462072|Primary|Baseline (Wk 0) Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Baseline (Wk 0)|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]|||Score||Standard Deviation|Mean
2808475|NCT00462020|Secondary|Length of Stay, Charges, Adverse Events||1 month|||||||
2808476|NCT00462020|Primary|Abscess After Appendectomy||1 month||||number of patients|||Number
2808477|NCT00461981|Primary|Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects|Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared.|Post Dose 1 (28 to 42 days post Dose 1)||||Units on a scale|||Number
2808478|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 35 days after Dose 2|Post Dose 2 (28 to 35 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and any post-Dose T-cell Elispot results (n=3; n=6)|||SPC/2 x 10^5 PBMCs||Full Range|Median
2808479|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 42 days after Dose 1|Post Dose 1 (28 to 42 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and post-Dose 1 T-cell Elispot results (n=12; n=15)|||SPC/2 x 10^5 PBMCs||Full Range|Median
2808480|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 2|Post Dose 2 (7 to 10 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=10; n=9).|||Counts of ASCs per 10^6 PBMCs||Full Range|Median
2808481|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1|Post Dose 1 (7 to 10 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=16; n=17).|||Counts of ASCs per 10^6 PBMCs||Full Range|Median
2808482|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).|||Titer||95% Confidence Interval|Geometric Mean
2808483|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).|||Titer||95% Confidence Interval|Geometric Mean
2808484|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).|||Titer||95% Confidence Interval|Geometric Mean
2808485|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).|||Titer||95% Confidence Interval|Geometric Mean
2808486|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).|||Titer||95% Confidence Interval|Geometric Mean
2808487|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).|||Titer||95% Confidence Interval|Geometric Mean
2808488|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).|||Titer||95% Confidence Interval|Geometric Mean
2808566|NCT00461682|Secondary|Number of Defecations Over 24h and Over 1 Week Following a Dose of SB-705498 (Monitored Using Bristol Stool Scoring Diary Kept 1 Week Pre- and 1 Week Post-dose)|Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (>3/day or < 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|7 days pre-dose and 7 days post-dose of each treatment period|||||||
2808489|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).|||Titer||95% Confidence Interval|Geometric Mean
2808490|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).|||Titer||95% Confidence Interval|Geometric Mean
2808491|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).|||Titer||95% Confidence Interval|Geometric Mean
2808492|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).|||Titer||95% Confidence Interval|Geometric Mean
2808493|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).|||Titer||95% Confidence Interval|Geometric Mean
2808494|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).|||Percentage of Participants|||Number
2808495|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).|||Percentage of Participants|||Number
2808496|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).|||Percentage of Participants|||Number
2808576|NCT00461630|Secondary|Stroke|Fatal or non-fatal|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
2808577|NCT00461630|Secondary|Major Coronary Events|Non-fatal myocardial infarction (MI) or coronary death|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
2808578|NCT00461630|Primary|Major Vascular Event|Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
2808497|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).|||Percentage of Participants|||Number
2808498|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).|||Percentage of Participants|||Number
2808499|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).|||Percentage of Participants|||Number
2808500|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).|||Percentage of Participants|||Number
2808501|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).|||Percentage of Participants|||Number
2808502|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).|||Percentage of Participants|||Number
2808503|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).|||Percentage of Participants|||Number
2808504|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).|||Percentage of Participants|||Number
2808579|NCT00461591|Secondary|Overall Survival|The number of months from randomization to death from any cause.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2812345|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|Baseline||||times per week||Standard Deviation|Mean
2808505|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).|||Percentage of Participants|||Number
2808506|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).|||Titer||95% Confidence Interval|Geometric Mean
2808507|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).|||Titer||95% Confidence Interval|Geometric Mean
2808508|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).|||Titer||95% Confidence Interval|Geometric Mean
2808509|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29)|||Titer||95% Confidence Interval|Geometric Mean
2808510|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).|||Titer||95% Confidence Interval|Geometric Mean
2808511|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).|||Titer||95% Confidence Interval|Geometric Mean
2808512|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).|||Titer||95% Confidence Interval|Geometric Mean
2808580|NCT00461591|Secondary|Disease Free Survival|The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2808513|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).|||Titer||95% Confidence Interval|Geometric Mean
2808514|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).|||Titer||95% Confidence Interval|Geometric Mean
2808515|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).|||Titer||95% Confidence Interval|Geometric Mean
2808516|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).|||Titer||95% Confidence Interval|Geometric Mean
2808517|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).|||Titer||95% Confidence Interval|Geometric Mean
2808518|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).|||Percentage of Participants|||Number
2808519|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).|||Percentage of Participants|||Number
2808520|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).|||Percentage of Participants|||Number
2808581|NCT00461591|Secondary|Disease Free Interval|The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2812346|NCT00435188|Primary|Usual Gait Speed|Best of two trials over 8-foot walk|Baseline||||meters/second||Standard Deviation|Mean
2808521|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29).|||Percentage of Participants|||Number
2808522|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).|||Percentage of Participants|||Number
2808523|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).|||Percentage of Participants|||Number
2808524|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).|||Percentage of Participants|||Number
2808525|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).|||Percentage of Participants|||Number
2808526|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).|||Percentage of Participants|||Number
2808527|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).|||Percentage of Participants|||Number
2808528|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).|||Percentage of Participants|||Number
2808582|NCT00461591|Secondary|Number of Recurrences Per Patient|The number of histologically confirmed recurrences during the course of the study.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||times||Standard Deviation|Mean
2808529|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).|||Percentage of Participants|||Number
2808530|NCT00461851|Secondary|Best Reported Response|The best reported response captures the proportion of patients with advanced or metastatic transitional cell carcinoma of the bladder that achieve a complete or partial response to the combination therapy with sorafenib, gemcitabine, and carboplatin.|Upon completion of study||||Participants|||Count of Participants
2808531|NCT00461851|Secondary|Dose Ruction (Toxicity)|To determine the toxicity of combination therapy with sorafenib, gemcitabine and carboplatin, dose reductions by drug are reported. The number of patients that were reduced in dosage are reported here.|Upon completion of study|17 patients were evaluable for toxicity. A total of 77 cycles of gemcitabine/carboplatin were administered with a median 4.5 cycles per patient.|||Participants|||Count of Participants
2808532|NCT00461851|Primary|Progression Free Survival (PFS)|The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.|Upon completion of study||||months||95% Confidence Interval|Median
2808533|NCT00461812|Primary|Efficacy as Assessed my Pulmonary Function Tests||change from baseline to study completion|There is no data available for this outcome measure. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB.||||||
2808534|NCT00461786|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause up to 5-year follow-up||||months||Full Range|Median
2808535|NCT00461786|Secondary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline until documented tumor progression (up to 44 months)||||months||Full Range|Median
2808536|NCT00461786|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 44 months)||||months||Full Range|Median
2808537|NCT00461786|Secondary|Number of Participants With Adverse Events by Grade|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle up to 5 year follow-up||||participants|||Number
2808538|NCT00461786|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 44 months)||||participants|||Number
2808539|NCT00461734|Secondary|6 Minute Hall-Walk Distance (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available|||meters||Inter-Quartile Range|Median
2808540|NCT00461734|Secondary|6 Minute Hall-Walk Distance (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available|||meters||Inter-Quartile Range|Median
2808541|NCT00461734|Secondary|Echocardiographic Measures of Left Ventricular Dyssynchrony|No analysis has been done for this section since that variable was not collected during the study.|At 2-year follow-up|No analysis has been done for this section since that variable was not collected during the study||||||
2808542|NCT00461734|Secondary|Brain Natriuretic Peptide Levels (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available|||picograms per milliliter||Full Range|Median
2808543|NCT00461734|Secondary|Brain Natriuretic Peptide Levels (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available|||picograms per milliliter||Full Range|Median
2808544|NCT00461734|Secondary|Incidence of Stroke||At 5-year follow-up (study extension)||||participants|||Number
2808545|NCT00461734|Secondary|All Cause Mortality||At 5-year follow-up (study extension)||||participants|||Number
2808546|NCT00461734|Secondary|Worsening of Heart Failure|"Worsening of heart failure can be defined as:~Heart failure-related hospitalization requiring intravenous heart failure therapy, or~Emergency department visit for heart failure requiring intravenous heart failure therapy, or~Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction <35%, and intravenous heart failure therapy is required or titrate therapy.~CRT-P or CRT-D upgrade."|At 5-year follow-up (study extension)||||episodes|||Number
2808547|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)||At 5-year follow-up (study extension)|Per Protocol Cohort with data available|||minutes per day||Standard Deviation|Mean
2808548|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)||At 5-years follow-up (study extension)|Intent to Treat Cohort with data available|||minutes per day||Standard Deviation|Mean
2808549|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)||At 2-year follow-up|Per Protocol Cohort with data available|||minutes per day||Standard Deviation|Mean
2808550|NCT00461734|Secondary|Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)||At 2-year follow-up|Intent to Treat Cohort with data available|||minutes per day||Standard Deviation|Mean
2808553|NCT00461708|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population|||percentage of participants|||Number
2808554|NCT00461708|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST|As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population|||percentage of participants|||Number
2808555|NCT00461708|Secondary|PFS|The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months|ITT population; only participants with an event (death or disease progression) were included in the analysis.|||months||95% Confidence Interval|Median
2808556|NCT00461708|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population|||participants|||Number
2808557|NCT00461708|Secondary|OS By Rash Grade|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
2808558|NCT00461708|Secondary|Number of Participants Who Died During the Study By Rash Grade||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population|||participants|||Number
2808559|NCT00461708|Secondary|OS At 6 Months|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
2808560|NCT00461708|Secondary|Number of Participants Who Died at 6 Months||Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population|||participants|||Number
2808561|NCT00461708|Primary|Overall Survival (OS) During the Study|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
2808562|NCT00461708|Primary|Number of Participants Who Died During the Study||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population|||participants|||Number
2808563|NCT00461682|Secondary|Average Daily Pain Scores at Baseline (Pre-dose), 1, 2, 3, 4, 5 and 6h Post-dose for Each Treatment Period|"Individual pain scores were collected at screening and pre and post dose during the anorectal physiological assessments. Average daily pain scores as captured in participants' diary cards were summarized descriptively and analyzed. The 11 point pain intensity numerical rating scale ranges from 0 to 10, where 0 represents No pain and 10 represents Worst pain imaginable. This was used for the subjective assessment of the pain over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|At Baseline (pre-dose) and each hour post-dose of each treatment period|||||||
2808564|NCT00461682|Secondary|Symptom Scoring and Quality of Life Assessments Over Period|Different scales used in this study included HAD, BDI, SF36, Bristol Stool Scoring, IBS QOL and SSS that were used to rate different scores on respective scales. Untreated pain leads to a decrease in daily function capability, social stresses, loss of work, an overall poor quality of life and a burden on healthcare resources. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Approximately up to 3 months|||||||
2808565|NCT00461682|Secondary|Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) Calculated Over Approximately 10 Days Pre- and Post-dose|Participants were rated on a scale based on following parameters - Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (>3/day or < 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|10 days pre-dose and post-dose of each treatment period|||||||
2808611|NCT00461305|Secondary|Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)|||mg/dL||Full Range|Mean
2808567|NCT00461682|Secondary|Contact Heat-evoked Potentials (CHEPs) - Optional, Assessed Pre-dose and 6h Post-dose of Each Treatment Period|For heat pain threshold measurement, temperature of the thermode was gradually increased from the baseline (32°C) at a rate of 1°C/s. The ramp was stopped and the temperature of the thermode was returned to the Baseline. This was repeated three times. The threshold temperatures and the average value were recorded by the computer. If the thermode temperature reached 50°C without the participant responding, the ramp was stopped and the temperature was returned to baseline automatically to prevent skin injury. This test was performed within two minutes. The respective cut-off temperature is then recorded for that trial. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Baseline (pre-dose) and 6h post-dose of each treatment period|||||||
2808568|NCT00461682|Secondary|Somatic Heat Pain Thresholds (Hand and Foot) Assessed Pre-dose and 6h Post-dose of Each Treatment Period|Evoked potentials were to be recorded from midline electrodes by placing a ground electrode on temporal lobe region. A low cut off filter with a time constant of 1.06103 and a frequency of 0.15 hertz (Hz) and a high cut off filter of 100Hz was to be applied. The impedance from all electrodes was maintained below 5 ohms (Ω) and the electroencephalogram (EEG) was recorded, digitized at a sampling rate of 500 Hz. Responses from ten stimuli were to be recorded from each participant with the thermode placed over foot and one hand (non-dominant side). The thermode heating rate was set at 70 degree Celsius per second (°C/s) and the cooling rate at 40°C/s. The baseline temperature was 32 °C, destination temperature 51 °C, and stimulus interval approximately of 7 seconds. The participants were allowed to withdraw any time. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.|Baseline (pre-dose) and upto 0-6h post-dose for each treatment period|||||||
2808569|NCT00461682|Secondary|Pain Intensity Difference (SPID6), as Derived From Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h Post-dose of Each Treatment Period|"Change from Baseline (pre-dose0 is the value at indicated time point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents No pain and 10 represents Worst pain imaginable was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period|||||||
2808570|NCT00461682|Secondary|Peak Pain Intensity Difference (PPID6), as Derived From Maximum Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h of Each Treatment Period|"No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Change from Baseline (pre-dose) is the value at indicated time-point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents No pain and 10 represents Worst pain imaginable was planned to be used for the subjective assessment of the pain."|Baseline (pre-dose) and up to 0-6 h of each treatment period|||||||
2808571|NCT00461682|Secondary|Rectal Sensory Thresholds to Thermal Stimulation (Contact Heat Device, Values Reported as in Study) at Pre-dose and 6h Post-dose of Each Treatment Period|Visceral hypersensitivity is defined as reduced pain and discomfort threshold to rectal stimuli. Rectal hypersensitivity was correlated with the degree of rectal hypersensitivity (up-regulation of TRPV-1 receptors) as measured by rectal thermal stimulation. Ongoing rectal pain intensity scale is 11-point numeric rating scale, where 0=Unnoticeable/No Pain, 10=Unbearable/Worst Pain. An average of daily scores over 1 week pre-dose and 1 week post-dose was recorded. Single measurements pre-dose and at hourly intervals within 6 hours post-dose were also recorded. Participants were planned to stay in the hospital for 6h post-dose and were planned to be discharged when physician was satisfied with their medical condition. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge.|Baseline (pre-dose) and 6h post-dose of each treatment period|||||||
2808572|NCT00461682|Secondary|Visual Analogue Scores for Rectal Distensions for Gas, Urgency to Defecate and Discomfort at Pre-dose and 6 h Post-dose of Each Treatment Period|"The VAS scores for assessment of rectal sensation for pain, gas, urgency and discomfort were analyzed separately. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents No pain and 10 represents Worst pain imaginable was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant."|Baseline (pre-dose) and up to 6 h post-dose of each treatment period|||||||
2808573|NCT00461682|Primary|Visual Analogue Scale (VAS) Pain Score to Rectal Distensions at Pre-dose and up to 6 Hours (h) Post-dose of Each Treatment Period|"This analysis was performed at 12, 24, 36 and 48 millimeters of mercury (mmHg) which was above the baseline operating pressure threshold. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents No pain and 10 represents Worst pain imaginable was planned to be used for the subjective assessment of the pain."|Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period|||||||
2808574|NCT00461630|Secondary|Mortality|All-cause mortality|During scheduled treatment period (median duration 3.9 years)||||participants|||Number
2808575|NCT00461630|Secondary|Coronary or Non-coronary Revascularisation||During scheduled treatment period (median duration 3.9 years)||||participants|||Number
2808584|NCT00461591|Secondary|Progression Rate at 2 Years|The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
2808585|NCT00461591|Secondary|Time to Recurrence|The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||months||Standard Error|Mean
2808586|NCT00461591|Primary|Recurrence Rate at 2 Years|The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.|2 years|Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.|||Participants|||Count of Participants
2808587|NCT00461552|Secondary|Body Weight (kg)||6 months||||kg||Standard Deviation|Mean
2808588|NCT00461552|Primary|Fasting Serum Triglycerides||6 months||||mg/dL||Full Range|Median
2808589|NCT00461513|Secondary|Hospitalization at 1 Year|Hospitalization at 1 year|12 months||||Participants|||Count of Participants
2808590|NCT00461513|Secondary|Mortality at 1 Year|Mortality at 1 year|12 months||||Participants|||Count of Participants
2808591|NCT00461513|Primary|Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.|The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.|12 months||||units on a scale||Standard Deviation|Mean
2808592|NCT00461500|Secondary|Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|7-point scale where 1=total impairment and 7=no impairment. Questions contain 32 items in four domains. Domains include Activity Limitation (11 items), Symptoms (12 items), Emotional Function (5 items), and Environmental Stimuli (4 items). 32 items produce one overall quality of life score. The 7 points scoring are different and depend on the item : they are the translation in French of the original questionnaire from Juniper. Possible AQLQ scores range from 1 to 7 (the mean of all the questions).|Baseline, Week 12|Intent-to-Treat population.|||Score on a scale||Standard Deviation|Mean
2808593|NCT00461500|Secondary|ACT Score in Classes at Week 12|Score is ranged from 5 (poor control) to 25 (complete control).|Week 12|Intent-to-Treat population.|||Particpants|||Number
2808594|NCT00461500|Secondary|Change From Baseline in Asthma Control Test (ACT) Score at Week 12|5 question test with various responses rating frequency of asthma events over 4-week period. Questions include occurrence of asthma affecting work/school; causing shortness of breath; symptoms (wheezing, coughing, shortness of breath, chest tightness, pain) wake you up at night; causing need for rescue medication; asthma control. Scale: 1=all of time, 2=most of time, 3=some of the time, 4=a little of the time, 5=none of the time. Possible ACT scores range from 5 to 25.|Baseline, Week 12|Intent-to-Treat population.|||Score on a scale||Standard Deviation|Mean
2808595|NCT00461500|Secondary|Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12|"Totally-controlled asthma is defined as no daily symptoms, no night-time awakenings, no exacerbations, no rescue medication, no emergency visits, no treatment related adverse events resulting in change in asthma therapy, >=80% predicted PEF. The number of subjects who achieved total-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.|||Participants|||Number
2808596|NCT00461500|Secondary|Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The median number of weeks to first achieve well-controlled asthma during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.|||Weeks||Full Range|Median
2808597|NCT00461500|Secondary|Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The number of participants who achieved well-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 -12|Intent-to-Treat population.|||Participants|||Number
2808598|NCT00461500|Secondary|Number of Participants With at Least One Exacerbation During 12-Week Treatment Period|Subjects will record exacerbations (defined as temporary PEF decrease, increase in salbutamol use) in a Daily Record Card (DRC). The number of events are categorized as those that showed a deterioration in asthma requiring administration of oral corticosteroids and/or a deterioration in asthma requiring emergency room visit and/or hospitalization (hosp.).|12-Week Treatment Period (Week 1 through Week 12)|Intent-to-Treat population.|||Participants|||Number
2808612|NCT00461305|Secondary|Change in Serum CA-125 From Baseline to Cycle 13|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||Units/mL||Full Range|Mean
2808599|NCT00461500|Secondary|Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Forced Expiratory Flow 25-75% (measured by a spirometer) is the average flow (or speed) of air coming out of the lung during the middle portion of the expiration. Age, height, and gender is used to determine what is normal. Change from BL could have been measured at any time during the study (up to Week 12), using the LOCF (for each individual, missing values are replaced by the last observed value of that variable). Change from BL is measured as percentage of predicted value, with height, gender, age, and race as variables (percentage of predicted value at endpoint minus value at BL).|Baseline through Week 12|Intent-to-Treat population.|||Percentage of predicted value||Standard Deviation|Mean
2808600|NCT00461500|Secondary|Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FVC is the total amount of air that can forcibly be blown out after full inspiration, measured in liters. A spirometer is the device used to measure FVC. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat|||Liters||Standard Deviation|Mean
2808601|NCT00461500|Secondary|Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Reversibility is calculated as the percentage improvement of FEV1 from baseline. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable. Percent reversibility of FEV1 was calculated as follows: (Post-bronchodilator FEV1 - pre-bronchodilator FEV1)/pre-bronchodilator FEV1 x 100. A negative difference indicates less reversibility.|Baseline through Week 12|Intent-to-Treat population.|||Percent change||Standard Deviation|Mean
2808602|NCT00461500|Secondary|Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Percent predicted is based on tables of normal values that use variables such as age, gender, and weight as a method of standardization. Spirometry results are expressed as a percentage, and are generally considered abnormal if less than 80 percent of the normal predicted value. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.|||Percentage predicted of FEV1||Standard Deviation|Mean
2808603|NCT00461500|Secondary|Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FEV1 is the amount of air (in liters) you can blow out within one second. A spirometer is the device used to measure FEV1. With normal lungs and airways you can normally blow out most of the air from your lungs within one second. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.|||Liters||Standard Deviation|Mean
2808604|NCT00461500|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12|Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.|Baseline, Weeks 5-12|Intent-to-Treat population are all randomized patients having received one study drug dose and had at least one complete efficacy assessment.|||Liters per minute (L/min)||Standard Deviation|Mean
2808605|NCT00461331|Secondary|Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place|Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.|Between 48, 72 and 96 hours after the last pump infusion line change||||pg/ml||Standard Deviation|Mean
2808606|NCT00461331|Secondary|Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place|Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.|48 to 100 hours after keeping the same pump infusion line in place||||µg/ml||Standard Deviation|Mean
2808607|NCT00461331|Primary|Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change|For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.|24 to 100 hours after last pump infusion line change|The analysis was per protocol, intention to treat. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin.|||Participants|||Number
2808608|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 13 (364 days) with 28 days per cycle|FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||scores on a scale||Standard Deviation|Mean
2808609|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 6 (168 days) with 28 days per cycle|FAS|||scores on a scale||Standard Deviation|Mean
2808610|NCT00461305|Secondary|Change in Serum CRP From Baseline to Cycle 13|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||mg/dL||Full Range|Mean
2808613|NCT00461305|Secondary|Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)|||Units/mL||Full Range|Mean
2808614|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||Percentage of participants|||Number
2808615|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||Percentage of participants|||Number
2808616|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||Percentage of participants|||Number
2808617|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||Percentage of participants|||Number
2808618|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808619|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||participants|||Number
2808620|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808621|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||participants|||Number
2808622|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||days||Full Range|Mean
2808623|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||days||Full Range|Mean
2808624|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||number of episodes||Full Range|Mean
2808625|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)|||number of episodes||Full Range|Mean
2808626|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||scores on a scale||Full Range|Mean
2808627|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||scores on a scale||Full Range|Mean
2808628|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||scores on a scale||Full Range|Mean
2808629|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||scores on a scale||Full Range|Mean
2808630|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808631|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808632|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808633|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808634|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 13|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808635|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 6|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808636|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 13|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808637|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 6|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808638|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808639|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808640|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808641|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808666|NCT00461045|Secondary|Number of Patients Receiving Marizomib (MRZ) in Each Cycle|A patient was counted in a cycle if the patient received at least one dose of study drug during the cycle.|Through study completion, an average of 6.09 weeks.||||Participants|||Count of Participants
2808667|NCT00461045|Secondary|Number of Cycles of Marizomib (MRZ)||Through study completion, an average of 6.09 weeks.||||cycles||Standard Deviation|Mean
2808642|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)|||participants|||Number
2808643|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808644|NCT00461305|Primary|Number of Participants With Intracyclic Bleeding at Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)|||participants|||Number
2808645|NCT00461292|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Number on a Scale (Score)||Standard Deviation|Mean
2808646|NCT00461292|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Centimeters of water (cm H2O)||Standard Deviation|Mean
2808647|NCT00461292|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Milliliters (mL) of urine||Standard Deviation|Mean
2808648|NCT00461292|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)|||Number of Weekly Episodes||Standard Deviation|Mean
2808649|NCT00461253|Primary|Breast Cancer Risk|Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.|retrospective, January 2000 to December 2007|Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users|||participants|||Number
2808650|NCT00461175|Other Pre-specified|Contraceptive Failure|Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis.|Within 12 months||||participants|||Number
2808651|NCT00461175|Primary|Uterine Perforation Rate|Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.|12 months after insertion|"Intention-to-treat (ITT) population. Number of Participants referring to the initially inserted IUS/IUD or the initial IUD insertion attempt."|||participants|||Number
2808652|NCT00461123|Secondary|Duration of Surgery|Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.|on the day of surgery, without any further allowable time window|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of duration of surgery; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||minutes||Standard Deviation|Mean
2808653|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline documentation of number of incontinence episodes per week; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||urinary incontinence episodes||Standard Deviation|Mean
2808668|NCT00461045|Secondary|Duration of MRZ Treatment|Duration of treatment is defined as the last dose date minus the first dose date of the dose cohort plus 1 expressed in weeks.|Through study completion, an average of 6.09 weeks.||||weeks||Standard Deviation|Mean
2817680|NCT00399542|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2808654|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of post-void residual (PVR) volume; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||milliliter (mL)||Standard Deviation|Mean
2808655|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst).|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of International Prostate Symptom Score (IPSS) total score; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."|||scores on a scale||Standard Deviation|Mean
2808656|NCT00461123|Primary|Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of peak urinary flow; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study, as displayed under Participants Flow."|||milliliter per second (mL/s)||Standard Deviation|Mean
2808657|NCT00461097|Secondary|Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid|Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.|4 years (48 months)||||percentage of participants|||Number
2808658|NCT00461097|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through the 2-year primary endpoint|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||participants|||Number
2808659|NCT00461097|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg|For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
2808660|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation|On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.|Initial day of dosing|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
2808661|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid|Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
2808662|NCT00461097|Primary|Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.|At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||percentage of participants|||Number
2808663|NCT00461045|Secondary|Maximum Observed Blood Drug Concentration (Cmax)||Samples collected on Cycle 1 Day 1 and Cycle 1 Day 11.|The sponsor elected not to analyze the pharmacokinetic (PK) samples collected, therefore, no PK results are obtained.||||||
2808664|NCT00461045|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|"Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug.~Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship."|Through study completion, an average of 6.09 weeks.||||TEAEs|||Number
2808665|NCT00461045|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug.~Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship."|Through study completion, an average of 6.09 weeks.||||Participants|||Count of Participants
2808669|NCT00461045|Primary|Number of Patients Exhibiting a Given Overall Response as Determined by Investigator|Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.|Through study completion, an average of 6.09 weeks.||||participants|||Number
2808670|NCT00461032|Secondary|Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.|8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2808671|NCT00461032|Secondary|Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants||8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2808672|NCT00461032|Secondary|Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)|Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.|8 Week treatment period initiated at the beginning of a school year|The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.|||Participants|||Number
2808673|NCT00461032|Primary|Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|"A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization."|8 Week treatment period initiated at the beginning of a school year|The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
2808674|NCT00460993|Primary|Sleep Efficiency|Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time|6 days||||percentage of sleep||Full Range|Median
2808675|NCT00460811|Secondary|Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period|During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).|||units on a scale||Standard Error|Least Squares Mean
2808676|NCT00460811|Secondary|Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period|Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 13 patients who dropped out prior to finishing 1 week of the trial have missing data.|||units on a scale||Standard Error|Least Squares Mean
2808677|NCT00460811|Secondary|Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis.|||units on a scale||Standard Error|Least Squares Mean
2808678|NCT00460811|Secondary|Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period|Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis.|||units on a scale||Standard Error|Least Squares Mean
2808679|NCT00460811|Secondary|Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period|SBMs were measured daily during the treatment period by patient calls to the IVRS.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).|||SBMs per week||Standard Error|Least Squares Mean
2808749|NCT00460577|Secondary|Pharmacoeconomic Analysis|Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.|4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||Cost in US Dollars||Full Range|Mean
2808680|NCT00460811|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).|||participants|||Number
2808681|NCT00460811|Primary|Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period|"The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period.~The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours."|Change from Baseline to Week 12|The Intent-to-treat (ITT) Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency)|||CSBMs per week||Standard Error|Least Squares Mean
2808682|NCT00460798|Primary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores|EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems|Baseline, 3, 6, 9 and 12 Months|FAS. n=number of participants with EORTC scale score data available at each specified time point|||Scores on Scale||Standard Deviation|Mean
2808683|NCT00460798|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status|Baseline, 3, 6, 9 and 12 Months|FAS. ECOG performance status data was not reported for 24, 32, 96, 174, and 174 participants at baseline, 3, 6, 9, and 12 months, respectively.|||Participants|||Number
2808684|NCT00460798|Primary|Time to Progression (TTP)|TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.|Start of Treatment up through 12 Months or Early Discontinuation|FAS. Number of participants with progression = 162; Number of participants censored = 190|||Months||95% Confidence Interval|Median
2808685|NCT00460798|Primary|Number of Participants With Objective Response|Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 Months or Early Discontinuation|FAS|||Participants|||Number
2808686|NCT00460798|Primary|Number of Participants With Categorical Best Overall Response|Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Start of Treatment up through 12 Months or Early Discontinuation|Full Analysis Set (FAS) = All participants who had taken at least 1 dose of study medication and had a post baseline efficacy measurement|||Participants|||Number
2808687|NCT00460746|Secondary|Median Change From Baseline in Glucose at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
2808688|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.||Week 48|ITT , LOCF.|||ratio of TC and HDL||Full Range|Median
2808689|NCT00460746|Secondary|Median Change From Baseline in HDL Cholesterol.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
2808690|NCT00460746|Secondary|Median Change From Baseline in LDL Cholesterol at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
2808691|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
2808692|NCT00460746|Secondary|Median Change From Baseline in Triglycerides at Week 48.||Week 48|ITT , LOCF.|||mg/dL||Full Range|Median
2808693|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.||Week 48|ITT , LOCF.|||cells/mm^3||Standard Deviation|Mean
2808694|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.||Week 48|Intent To Treat (ITT), last observation carried forward (LOCF).|||cells/mm^3||Full Range|Median
2808695|NCT00460746|Secondary|Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.|||percentage of participants|||Number
2808696|NCT00460746|Primary|Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.|||percentage of participants|||Number
2808697|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808698|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808699|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808700|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||seconds||Standard Deviation|Mean
2808701|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808702|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|"The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The +1 (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5."|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808703|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808704|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808705|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808706|NCT00460655|Secondary|Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase|The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||seconds||Standard Deviation|Mean
2808707|NCT00460655|Secondary|Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808708|NCT00460655|Secondary|Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase|"The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The +1 (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5."|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Points on a scale||Standard Deviation|Mean
2808709|NCT00460655|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12)|Change from baseline in MAS ankle score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score|||Score*week||Standard Deviation|Mean
2808710|NCT00460603|Secondary|Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2|"PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was at its worst. Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was as bad as you can imagine or interfered completely with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms."|Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||units on scale||Standard Deviation|Mean
2808711|NCT00460603|Secondary|Overall Survival (OS): Phase 2|Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant|ITT population included all randomized participants , with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||days||95% Confidence Interval|Median
2808712|NCT00460603|Secondary|Time to Treatment Failure (TTF): Phase 2|TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||days||95% Confidence Interval|Median
2808713|NCT00460603|Secondary|Progression-Free Survival (PFS): Phase 2|"Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation."|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||days||95% Confidence Interval|Median
2808750|NCT00460577|Secondary|Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events|Not posted: see comment in Limitations and Caveats.|4 hours|||||||
2812347|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2808714|NCT00460603|Secondary|Duration of Response (DR): Phase 2|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. 'N' (Number of participants analyzed)= those participants who were evaluable for this measure.|||days||95% Confidence Interval|Median
2808715|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2808716|NCT00460603|Secondary|Clearance (CL) For Bevacizumab: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
2808717|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
2808718|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1|PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
2808719|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808720|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808721|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2808784|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.|Day 0|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808722|NCT00460603|Secondary|Clearance (CL) For Irinotecan: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
2808723|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
2808724|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1|Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
2808725|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808726|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808727|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2808728|NCT00460603|Secondary|Clearance (CL) For 5-Fluorouracil: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
2808729|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1||Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
2808730|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1|PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
2808739|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2808731|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808732|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808733|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2808734|NCT00460603|Secondary|Clearance (CL) For Oxaliplatin: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||95% Confidence Interval|Geometric Mean
2808735|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
2808736|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1|PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
2808737|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808738|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808751|NCT00460577|Primary|Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||Liters/minute||Standard Deviation|Mean
2808740|NCT00460603|Secondary|Apparent Oral Clearance (CL/F) For Axitinib: Phase 1|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
2808741|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.||||||
2808742|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1|PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||95% Confidence Interval|Geometric Mean
2808743|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2808744|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram hour per milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
2808745|NCT00460603|Primary|Percentage of Participants With Objective Response: Phase 2|Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|Intent-to-treat (ITT) population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2808746|NCT00460577|Primary|Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||score on a scale||Standard Deviation|Mean
2808747|NCT00460577|Primary|Mean Change in Pulse Oxymetry From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.|Baseline, 4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||percentage||Standard Deviation|Mean
2808748|NCT00460577|Primary|Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.|||Liters||Standard Deviation|Mean
2808826|NCT00460265|Secondary|Progression Free Survival|Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.|Every 6 weeks until disease progression or deaths, upto 56 months|ITT|||months||95% Confidence Interval|Median
2808752|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808753|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808754|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808755|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Limb Posture at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Weeks 12 to 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808756|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Dressing at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808757|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Pain at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808758|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Hygiene at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability; 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808783|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.|Day 30 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808759|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Principal Measure at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808760|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Finger Score From at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|"The investigator assessed the MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The +1 (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5."|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808761|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Wrist Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|"The investigator assessed the MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=no increase in muscle tone to 4=affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The +1 (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder ([less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5."|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808762|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808763|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808764|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808765|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase|DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808766|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase|DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808767|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase|DAS score of pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808768|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase|DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2817681|NCT00399542|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2808769|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808770|NCT00460564|Secondary|Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase|"The investigator assessed MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The +1 (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5."|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808771|NCT00460564|Secondary|Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase|"The investigator assessed MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The +1 (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5."|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Points on a scale||Standard Deviation|Mean
2808772|NCT00460564|Secondary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis (HA) and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the area under the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Score*week||Standard Deviation|Mean
2808773|NCT00460564|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score|||Score*week||Standard Deviation|Mean
2808774|NCT00460551|Primary|Progression Free Survival Verified by Imaging Techniques.|Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16|Until disease progression|Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.|||Participants|||Number
2808775|NCT00460551|Secondary|Adverse Events|Number of participants reporting at least one adverse event|Up to 3 months|Number of patients reporting at least one adverse event|||participants|||Number
2808776|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.|Day 730 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808777|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.|Day 547 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808778|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.|Day 364 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808779|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.|Day 240 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808780|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.|Day 150 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808781|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.|Day 90 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808782|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.|Day 60 after initial vaccination|Analyses are ITT. No imputation techniques were used.|||Titer||95% Confidence Interval|Geometric Mean
2808785|NCT00460525|Secondary|Incidence Density of Clinical Malaria Episode|Clinical malaria episode was defined by significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C. Event rate was determined by dividing the number of episodes (150 for the Rabies group and 121 for the FMP2.1/ASO2A group) by the number of Person Years at Risk (PYAR) (126.341 for Rabies group and 127.411 for the FMP2.1/ASO2A group).|Between randomization and 6 months after 3rd immunization.|Analyses are ITT.|||Events Per PYAR|||Number
2808786|NCT00460525|Primary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.|24 months after initial vaccination||||Participants|||Number
2808787|NCT00460525|Primary|Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.|Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.|Occurring between randomization and 6 months after the assigned date of the 3rd immunization.||||Participants|||Number
2808788|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after third vaccination|All subjects receiving the vaccination are included.|||Adverse Events|||Number
2808789|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after second vaccination|All subjects receiving the vaccination are included.|||Adverse Events|||Number
2808790|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after first vaccination|All subjects receiving the vaccination are included.|||Adverse Events|||Number
2808791|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the third vaccination|All subjects receiving the vaccination are included.|||Participants|||Number
2808792|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the second vaccination|All subjects receiving the vaccination are included.|||Participants|||Number
2808793|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after first vaccination|All subjects receiving the vaccination are included.|||Participants|||Number
2808794|NCT00460434|Secondary|Incontinence Severity Index|Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.|Baseline, 3 months, and 12 months post-surgery|Women who completed the Incontinence Severity Index survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
2808795|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Stress Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI stress subscale survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
2808796|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Irritative Symptom Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI irritative symptom subscale survey at baseline and 3 months after the index surgery.|||units on a scale||Standard Deviation|Mean
2808797|NCT00460434|Secondary|Urinary Distress Inventory (UDI) Obstructive Symptom Subscale|Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the UDI obstructive symptom subscale survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
2808798|NCT00460434|Secondary|Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)|PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 months post-surgery|Women who completed the PFDI UDI survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
2820645|NCT00379808|Other Pre-specified|Monocyte Chemotactic Protein-1 (MCP-1)|biomarker was measured by enzyme-linked immunosorbant assay (ELISA)|1 month|those who completed the entire study|||pg/ml||Inter-Quartile Range|Median
2808799|NCT00460434|Secondary|Treatment for Incontinence|The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.|3 months post-surgery|Women who reported whether or not they needed treatment for any urinary incontinence.|||Participants|||Count of Participants
2808800|NCT00460434|Secondary|Symptoms of Incontinence|"Symptoms that were at least moderately bothersome to the participant (as measured by a response of moderately or quite a bit to any of the four items on the Pelvic Floor Distress Inventory regarding leakage)."|3 and 12 Months Post-surgery|Women who completed questions in the Pelvic Floor Distress Inventory regarding leakage 3 and 12 months after their index surgery.|||Participants|||Count of Participants
2808801|NCT00460434|Secondary|Positive Cough Stress Test|A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.|3 and 12 Months Post-surgery|Women who came in for 3 and 12 month post-op office visits and completed a cough stress test.|||Participants|||Count of Participants
2808802|NCT00460434|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey|This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.|Baseline, 3 months, and 12 Months post-surgery|Women who completed the Medical Outcomes Study 36-Item Short Form Health Survey at baseline and 3 and 12 months after the index surgery.|||units on a scale||Standard Deviation|Mean
2808803|NCT00460434|Primary|Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery|Defined as a positive cough stress test or report of bothersome incontinence symptoms.|12 months post-surgery||||Participants|||Count of Participants
2808804|NCT00460434|Primary|Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence|Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.|3 months post-surgery||||Participants|||Count of Participants
2808805|NCT00460421|Secondary|Long-Term Follow-Up: Overall Survival|Overall survival was defined as the number of days from the date of first investigational product administration to the date of death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||months||Full Range|Median
2808806|NCT00460421|Secondary|Long-Term Follow-Up: Progression Free Survival|Progression free survival (PFS) was defined as the number of days between the date of first investigational product administration and the date when physical or radiological evidence of disease progression is determined or death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||months||Full Range|Median
2808807|NCT00460421|Secondary|Long-Term Follow-Up: Incidence of Secondary Malignancies||Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
2808808|NCT00460421|Secondary|Pharmacokinetics of Palifermin, AUCtau After the 3rd IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)~Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||ng*hr/mL||Full Range|Median
2808809|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Area Under the Concentration Time Curve From Zero to the End of the Dosing Interval (AUCtau) After the 1st IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)~Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||ng*hr/mL||Full Range|Median
2808810|NCT00460421|Secondary|Pharmacokinetics of Palifermin, t½,z After the 3rd IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||hour||Full Range|Median
2808811|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Terminal Half-life (t½,z) After the 1st IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||hour||Full Range|Median
2808812|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Volume of Distribution at Steady State (Vss) After the 1st IV Bolus Injection for Multiple Dose Levels||Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||mL/kg||Full Range|Median
2808827|NCT00460265|Secondary|Time to Response|Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.|Every 6 weeks until disease progression, upto 56 months|Included only those subjects with a confirmed complete response or partial response.|||months||Inter-Quartile Range|Median
2808813|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Clearence (CL) After the 1st Intravenous (IV) Bolus Injection for Multiple Dose Levels|Clearence was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity where the dose was given in amount palifermin actually administered.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.|||mL/hr/kg||Full Range|Median
2808814|NCT00460421|Secondary|Incidence of Laboratory Abnormalities|The percentage of participants with a laboratory value outside the normal ranges during the study.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
2808815|NCT00460421|Secondary|Incidence of Severe Adverse Events (AEs)|The percentage of participants with a severe AE during the study was assessed.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
2808816|NCT00460421|Secondary|Incidence of Serum Palifermin Antibody Formation|The percentage of participants developing palifermin antibodies during the study was assessed.|Approximately 4 month duration (Through Day + 100 (+/- 40 days))|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
2808817|NCT00460421|Primary|Incidence of Dose Limiting Toxicities (DLTs)|"A DLT is appearance of side effects during treatment severe enough to prevent further increase in dosage or strength of treatment agent, or to prevent continuation of treatment at any dosage level.~A DLT was defined as: Grade 3 or 4 AE [based on Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) v3.0] considered by the investigator to be related to palifermin with the exceptions: Grade 3 erythema, pruritus or rash that resolves within 7 days of the last dose of palifermin.~The percentage of particiapnts with a DLT during the study was assessed."|Approximately 1 month duration (Day -10 through Day +16)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.|||percentage of participants|||Number
2808818|NCT00460408|Secondary|Number of Participants With Serious Hypersensitivity Reactions|Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms.|Baseline up to 2 years|Safety Population|||participants|||Number
2808819|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≥ 75 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
2808820|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 65 to 74 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
2808821|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 51 to 64 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
2808822|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≤50 years old|||percent per injection|Participants||Number
2808823|NCT00460408|Primary|Incidence of POAEs Per Injection Reported by Gender (Females)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of female participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
2808824|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Gender (Males)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of male participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
2808825|NCT00460408|Primary|Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection|POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population: participants who received at least 1 Macugen (pegaptanib sodium) injection; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.|||percent per injection|Participants||Number
2808829|NCT00460265|Secondary|Duration of Response|Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).|Every 6 weeks until disease progression, up to 56 months|Included only those subjects with a confirmed complete or partial response.|||months||95% Confidence Interval|Median
2808830|NCT00460265|Secondary|Overall Response Rate|An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.|Every 6 weeks until disease progression, up to 56 months|The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H)|||subjects|||Number
2808831|NCT00460265|Primary|Overall Survival|Time from randomization to death|Upto 56 months|Intention to treat (ITT)|||months||95% Confidence Interval|Median
2808832|NCT00460239|Primary|Physiologic Effects as Assessed by Pupil Diameter||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||millimeters||Standard Deviation|Mean
2808833|NCT00460239|Primary|Physiologic Effects as Assessed by Oxygen Saturation||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||percentage of saturated hemoglobin||Standard Deviation|Mean
2808834|NCT00460239|Primary|Physiologic Effects as Assessed by Body Temperature||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||Degrees Fahrenheit||Standard Deviation|Mean
2808835|NCT00460239|Primary|Physiologic Effects as Assessed by Heart Rate||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||beats/min||Standard Deviation|Mean
2808836|NCT00460239|Primary|Physiologic Effects as Assessed by Blood Pressure||Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||mmHg||Standard Deviation|Mean
2808837|NCT00460239|Primary|Psychomotor/Cognitive Performance Effects Assessed by Trails B|The Trails B task specifically measures set shifting and executive functioning within the Trail-Making Test. Part B consists of 25 circles distributed over a sheet of paper. Participants are asked to connect the circles in an ascending pattern, alternating between numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||minutes||Standard Deviation|Mean
2808838|NCT00460239|Primary|Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST)|Digit Symbol Substitution Test (DSST) is a sub-test within the Wechsler Adult Intelligence Scale and is frequently used to assess psychomotor performance changes associated with drug effects. The higher the percent correct on this measure the better the performance.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)||||percentage of correct answers||Standard Deviation|Mean
2808839|NCT00460239|Primary|Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS)|Opioid agonist effects measured by peak change from baseline drug effect visual analog scale. Scores range from 0 (not all all) to 100 (extremely); higher scores indicate a stronger drug effect.|Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks)|Subjects who completed all test conditions.|||units on a scale||Standard Error|Mean
2808840|NCT00460109|Secondary|Time to Subsequent Therapy|Time to subsequent therapy is defined to be the time from the end of active treatment date to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier.|Up to 5 years||||months||Full Range|Median
2808841|NCT00460109|Secondary|Duration of Response|Duration of response (DOR) is defined as the time from the date at which the patient's objective status is first noted to be either a CR, CRu or PR to the earliest date of progression. The distribution of DOR will be estimated using Kaplan-Meier methods. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.|Up to 5 years|Overall Number of Participants Analyzed reflects only the number of participants with reported data for this outcome.|||months||95% Confidence Interval|Median
2808842|NCT00460109|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier. Progression is defined using the response criteria for non-Hodgkin's lymphoma, as at least a 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or non-responders, or appearance of any new lesion during or at the end of therapy.|Up to 5 years||||||95% Confidence Interval|Median
2808843|NCT00460109|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years||||||95% Confidence Interval|Median
2808900|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808844|NCT00460109|Primary|Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response)|A confirmed tumor response is defined to be either a CR, CRu or PR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.|Up to 5 years||||proportion of participants||95% Confidence Interval|Number
2808845|NCT00460031|Secondary|Ratio of Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the ratio of BDCA-2 to BDCA-1 cells|Week 8|All patients who completed the study|||ratio||Standard Deviation|Mean
2808846|NCT00460031|Secondary|Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the levels of CD4+ FoxP3+ Regulatory T cells|Week 8|All patients who completed the study|||cells/ul||Standard Deviation|Mean
2808847|NCT00460031|Secondary|Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0|Patients will be evaluated for toxicity every 2 weeks during the first cycle. Thereafter, evaluations will be done every 28 days or more frequently if clinically indicated.|Up to 30 days after discontinuation of treatment|All patients who received at least one treatment in the study|||participants|||Number
2808848|NCT00460031|Secondary|Time to Progression|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|One year (12 months) after start of treatment|Patients with disease progression|||Months||95% Confidence Interval|Median
2808849|NCT00460031|Primary|Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|28 days|All patients who completed the study|||participants|||Number
2808850|NCT00459979|Secondary|Median Size Reduction Among Tumors With Some Shrinkage|The median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter|1 year from start of treatment||||cm|Participants|Full Range|Median
2808851|NCT00459979|Secondary|Number of Tumors With 30% Reduction in Size|Number of tumors with at least 30% reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol- after at least one cycle of Sunitinib|||tumors|Participants||Number
2808852|NCT00459979|Secondary|Number of Tumors Which Decreased in Size|Number of tumors with at least some reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - after at lease one cycle of Sunitinib|||tumors|Participants||Number
2808853|NCT00459979|Secondary|Percent Decrease of Diameter of Primary Tumors|Median percent decrease in size in all primary renal cell carcinoma tumors. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib|||percentage of tumors diameter decrease|Participants|Full Range|Median
2808854|NCT00459979|Secondary|Progression Free Survival|Progression free survival is defined as the amount of time (in months) between the start of treatment and documented RECIST defined progression. RECIST progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition to an absolute increase of at least 5mm.|1 year from start of treatment||||months||Full Range|Median
2808855|NCT00459979|Secondary|The Number of Patients With Any Type of Complication or Adverse Event|The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.|1 year from start of treatment||||participants|||Number
2808856|NCT00459979|Primary|Response to Sunitinib Therapy|Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib|||participants|||Number
2808857|NCT00459953|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)|6 months||||participants|||Number
2808858|NCT00459875|Primary|Overall Objective Response Rate as Measured by RECIST||2 years||||participants|||Number
2808943|NCT00459667|Primary|Liver Enzyme Elevations|"The variable Liver enzyme elevations will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.|||Percentage of participants|||Number
2808859|NCT00459862|Secondary|Overall Response Rate|"To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Participants will be evaluated every cycle during treatment, up to 2 years|All 34 participants were evaluable for this endpoint.|||percentage of patients||95% Confidence Interval|Number
2808860|NCT00459862|Secondary|Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.|"Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD."|From study enrollment to the first date of disease progression|All 34 participants were evaluable for this endpoint.|||participants|||Number
2808861|NCT00459862|Secondary|Determine the Clinical Toxicities of This Drug in This Participant Population.|The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.|Participants will be evaluated every cycle during treatment|All 34 participants were evaluable for adverse events.|||participants|||Number
2808862|NCT00459862|Secondary|Progression-free Survival Assessed by RECIST||From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years|All 34 participants were analyzed for this endpoint.|||months||95% Confidence Interval|Median
2808863|NCT00459862|Secondary|Overall Survival||From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years|All 34 participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2808864|NCT00459862|Primary|Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)|The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.|6 months|All 34 participants were analyzed for this endpoint.|||percentage of participants|||Number
2808865|NCT00459810|Secondary|Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response|These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.|Measured after 4 cycles of combination therapy|||||||
2808866|NCT00459810|Secondary|Time to Death|Defined as time from Day 1 of study regimen to Date of death from any cause.|Measured at Date of Death from any cause||||Months||95% Confidence Interval|Median
2808867|NCT00459810|Secondary|Time to Disease Progression|Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression|At time of progression by PSA or RECIST criteria||||Days||95% Confidence Interval|Median
2808868|NCT00459810|Secondary|Measurable Disease Response Rate (Soft Tissue)|Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).|While receiving study agents (on average, 3 months)||||Participants|||Number
2808869|NCT00459810|Primary|Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%|PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.|While receiving study agents (on average, 3 months)||||Participants|||Number
2808870|NCT00459732|Secondary|Osteocalcin, a Marker of Bone Formation|Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups|Baseline to 18 months|Intention to treat analysis|||ng/mL||Standard Deviation|Mean
2808871|NCT00459732|Primary|Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)||Baseline to 18 months|Intention to treat analysis in those who completed the 18 month timepoint (zinc vs. placebo)|||Percent change||Standard Deviation|Mean
2808872|NCT00459732|Primary|Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)|Change in pa spine bone mineral density by DXA between baseline and 18 months|0 to 18 months|Intention to treat analysis of all subjects who completed the protocol in each arm of the study (zinc vs. placebo).|||Percent Change||Standard Deviation|Mean
2808873|NCT00459706|Secondary|Participant Satisfaction at Endpoint Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean participant satisfaction was determined for each cluster of participants. Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
2808874|NCT00459706|Secondary|Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 3 DMARDs who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants receiving only 3 DMARDs who reported themselves as very satisfied, satisfied , or not satisfied for the specified treatment arm.|||percentage of participants|||Number
2808958|NCT00459368|Secondary|Patient Medical Care Costs||1 year|||||||
2808959|NCT00459368|Secondary|Patient-physician Communication (Patient Reported Measure)||survey following intervention period|||||||
2808875|NCT00459706|Secondary|Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 2 DMARDs, who reported themselves as very satisfied, satisfied, or not satisfied. n=number of participants receiving only 2 DMARDs who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm.|||percentage of participants|||Number
2808876|NCT00459706|Secondary|Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 1 DMARD who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.|||percentage of participants|||Number
2808877|NCT00459706|Secondary|HAQ-DI Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants. Disability score ranged from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
2808878|NCT00459706|Secondary|Physician's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||millimeters on the VAS||Standard Deviation|Mean
2808879|NCT00459706|Secondary|Participant's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participants' mean Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||millimeters on the VAS||Standard Deviation|Mean
2808880|NCT00459706|Secondary|DAS28 Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean DAS28 Score was determined for each cluster of participants. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
2808881|NCT00459706|Secondary|RA Duration Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean RA Duration was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.|||years||Standard Deviation|Mean
2808901|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808960|NCT00459368|Secondary|Readiness to Improve ICS Adherence (Transtheoretical Model)||survey following intervention period|||||||
2808882|NCT00459706|Secondary|Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The percentage of participants with prior self-injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||percentage of participants|||Number
2808883|NCT00459706|Secondary|Percentage of Participants With Prior Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants with prior injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||percentage of participants|||Number
2808884|NCT00459706|Secondary|PAM Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean PAM Score was determined for each cluster of participants. Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
2808885|NCT00459706|Secondary|HAD Depression Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Depression Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
2808886|NCT00459706|Secondary|HAD Anxiety Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Anxiety Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.|||units on a scale||Standard Deviation|Mean
2808887|NCT00459706|Secondary|Percentage of Participants at University Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at the university level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.|||percentage of participants|||Number
2808888|NCT00459706|Secondary|Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants at all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.|||percentage of participants|||Number
2808902|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808961|NCT00459368|Secondary|Patient Self-efficacy to ICS Treatment||survey following intervention period|||||||
2808889|NCT00459706|Secondary|Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants with only reading/writing capacity was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.|||percentage of participants|||Number
2808890|NCT00459706|Secondary|Percentage of Female Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants who were female was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants (male+female) across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants (male+female) who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and gender.|||percentage of female participants|||Number
2808891|NCT00459706|Secondary|Percentage of Male Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants who were male was determined for each cluster of participants.|Day 84|mITT. n=number of participants (male plus female) who reported themselves as being very satisfied, satisfied, or not for the specified treatment arm.|||percentage of male participants|||Number
2808892|NCT00459706|Secondary|Age Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean age was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 age clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm.|||years||Standard Deviation|Mean
2808893|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808894|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808895|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept? Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808896|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808897|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808898|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808899|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808962|NCT00459368|Secondary|Oral Steroid Use||1 year|||||||
2808903|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808904|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808905|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808906|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808907|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808908|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808909|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808910|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808911|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808912|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal? Participants specified their responses on a 5-point Likert scale: 0=<5 minutes to 4=>30 minutes.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808913|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808914|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808915|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808929|NCT00459706|Secondary|Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Results are reported by duration of RA: <=3 years, >3-6 years, >6-13 years, >13 years.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808916|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808917|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808918|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808919|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?|"Score indicated satisfaction in response to the question How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2808920|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?|"Score indicated satisfaction in response to the question How satisfied are you with your health? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2808921|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?|"Score indicated satisfaction in response to the question Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2808922|NCT00459706|Secondary|Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score|The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety. Higher score indicated that the participant was more anxious.|Day 84|mITT. N=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2808923|NCT00459706|Secondary|Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior injection experience. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. n=evaluable participants in that category.|||units on a scale||Standard Deviation|Mean
2808924|NCT00459706|Secondary|Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants were categorized into those who received only 1 DMARD, only 2 DMARDs, only 3 DMARDs, and at least 3 DMARDs.|Day 84|mITT; LOCF. N=total evaluable participants. n=total evaluable participants for that category.|||units on a scale||Standard Deviation|Mean
2808925|NCT00459706|Secondary|Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The 20-item HAQ-DI assessed the extent of participants' functional ability. Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health. Results are reported by categories of HAQ-DI scores observed: <=0.9, >0.9-1.4, >1.4-1.9, >1.9.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808926|NCT00459706|Secondary|Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active). Results are reported by VAS scores observed for physician's global assessment of RA activity: <=47 mm, >47-61 mm, >61-72 mm, >72 mm.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808927|NCT00459706|Secondary|Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active). Results are reported by VAS scores observed for the participant's global assessment of RA activity: <=50 mm, >50-67 mm, >67-79 mm, >79 mm.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808928|NCT00459706|Secondary|Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6. Results are reported by categories of DAS28 score: <=4.7, >4.7-5.4, >5.4-6.2, >6.2.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808930|NCT00459706|Secondary|Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior self-injection experience. Higher scores indicated greater satisfaction in the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=evaluable participants for that category.|||units on a scale||Standard Deviation|Mean
2808931|NCT00459706|Secondary|Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Results reported by PAM score: <=49.9, >49.9-56.4, >56.4-66, >66.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808932|NCT00459706|Secondary|Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression. Responses scored on a 4-point scale; each question was graded in a different way. Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health. Categories are depression subscale scores.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808933|NCT00459706|Secondary|Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety. Responses scored on a 4-point scale; each question was graded in a different way. Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health. Categories are anxiety subscale scores.|Day 84|mITT; LOCF.|||units on a scale||Standard Deviation|Mean
2808934|NCT00459706|Secondary|Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.|Day 84|mITT; LOCF. N=total participants with evaluable data. n=participants with evaluable data for that category.|||units on a scale||Standard Deviation|Mean
2808935|NCT00459706|Secondary|Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=participants evaluable in that category.|||units on a scale||Standard Deviation|Mean
2808936|NCT00459706|Secondary|Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Results are reported by age categories: <=46 years, >46-55 years, >55-65 years, >65 years.|Day 84|mITT; last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2808937|NCT00459706|Secondary|Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 84|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808938|NCT00459706|Secondary|Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 28|mITT. N=participants with evaluable data.|||percentage of participants|||Number
2808939|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Per-protocol (PP): mITT participants who completed the study with no major protocol violation. N=participants with evaluable data.|||units on a scale||Standard Deviation|Mean
2808940|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Modified Intent-to-Treat (mITT): All randomized participants who received at least 1 injection of test article and had at least 1 available evaluation after the first administration of test article. Number of participants analyzed (N) = participants with evaluable data.|||units on a scale||Standard Deviation|Mean
2808941|NCT00459667|Secondary|Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values|Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.|309 days|For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).|||Percentage of participants|||Number
2808942|NCT00459667|Primary|Hematological Abnormalities|"The variable Hematological abnormalities will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.|||Percentage of participants|||Number
2808963|NCT00459368|Secondary|Asthma-related Hospitalizations||1 year|||||||
2808944|NCT00459667|Primary|Injection-site Reactions|"The variable Injection-site reactions will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.|||Percentage of participants|||Number
2808945|NCT00459667|Primary|Flu-like-syndrome|"The variable Flu-like-syndrome will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.|||Percentage of participants|||Number
2808946|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Per-protocol population (PP) consisted of ITT patients who completed the study without protocol deviations that led to exclusion according to criteria defined before database lock The per-protocol population was used to provide confirmation of efficacy findings from the ITT population. Last Observation Carried Forward (LOCF).|||Percentage of participants|||Number
2808947|NCT00459537|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.|Week 52|The Safety population consisted of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2808948|NCT00459537|Secondary|Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)|||Percentage of participants|||Number
2808949|NCT00459537|Secondary|Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.|Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)|||Percentage of participants|||Number
2808950|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Intent-to-treat population (ITT) population consisted of all patients who were randomized and dispensed study drug. Last Observation Carried Forward (LOCF)|||Percentage of participants|||Number
2808951|NCT00459381|Secondary|Time to Progression or Progression Free Survival|"PFS for patients who died on treatment or within 30 days of the end of treatment w/out progression date, was date of death. All other pts without documented progression were censored at the date of last follow-up prior to start new treatment.~All 35 patients were included in an intent to treat analysis for PFS and OS. 3 pts censored for PFS, all less than 2 wks after study registration."|1 year||||weeks||95% Confidence Interval|Median
2808952|NCT00459381|Secondary|Overall Survival|calculated from study registration until date of death or patient censored at the last date known alive|From date of registration to date of death due to any cause, assessed up to 2 years|All 35 patients were included in an intent to treat analysis for PFS and OS.|||weeks||95% Confidence Interval|Median
2808953|NCT00459381|Secondary|Best Radiographic Response|"Using the Macdonald criteria, the best MRI image response while the patient was on active treatment.~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|3 years||||percentage of participants|||Number
2808954|NCT00459381|Secondary|Overall Radiographic Response (ORR) Rate|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|2 years|34 pts had follow-up scans and wee evaluable for objective radiographic response (ORR)|||percent||95% Confidence Interval|Number
2808955|NCT00459381|Secondary|Most Common Toxicities Experienced After at Least One Dose of Pazopanib|NCI Common Toxicity Criteria (CTCAE) version 3.0. All patients that received at least one dose of pazopanib were evaluable. All events recorded that were related to drug were calculated per patient.|Up to 2 years||||percentage of participants|||Number
2808956|NCT00459381|Primary|Number of Participants Discontinuing Treatment Due to Toxicity|Use NCI Common toxicity Criteria Adverse Event Version 3.0 to grade toxicities. Any patient who received at least one dose of pazopanib was evaluable for toxicity. Calculated the number of participants who had an event that was related to pazopanib that caused the patient to stop treatment due to this event.|2 years||||Participants|||Count of Participants
2808957|NCT00459381|Primary|6 Months Progression-free Survival|Calculated from study registration till 6month time point. Progression defined by Macdonald criteria Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration|6 months||||percent||95% Confidence Interval|Number
2808965|NCT00459368|Primary|Patient Adherence to Inhaled Corticosteroids (ICS)|Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.|1 year||||Percent of ICS medication taken||Standard Deviation|Mean
2808966|NCT00459355|Primary|Caregiver Self-efficacy|Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.|3 months after baseline||||units on a scale||Standard Deviation|Mean
2808967|NCT00459355|Secondary|Care Recipient Risky Behaviors and Accidents|The Risky Behavior Checklist listed common risky behaviors and accidents exhibited by care recipients with dementia based on previous research. Potential scores ranged from 0 - undetermined. The maximum score is undetermined because the measure represents the caregiver count of the number of times an incident occurred. In this study, sum scores ranged from 0 - 180.|3 months after baseline||||number of risky behaviors and accidents||Standard Deviation|Mean
2808968|NCT00459355|Primary|Caregiver Strain|Caregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.|3 months after baseline||||units on a scale||Standard Deviation|Mean
2808969|NCT00459342|Other Pre-specified|Phospho-Src (pSrc) Expression||Baseline||||participants|||Number
2808970|NCT00459342|Other Pre-specified|Epidermal Growth Factor Receptor (EGFR) Copy Number||Baseline||||participants|||Number
2808971|NCT00459342|Other Pre-specified|Epidermal Growth Factor Receptor (EGFR) Mutational Status||Baseline||||participants|||Number
2808972|NCT00459342|Other Pre-specified|Time to Progression (TTP)||Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks|Seven patients discontinued dasatinib because of toxicity or unrelated medical problems (i.e., not progression) and are not evaluable for progression.|||days||Standard Deviation|Mean
2808973|NCT00459342|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.|Time from start of treatment to time of progression or death, assessed at 2 months|Four participants were not evaluable for response.|||months||95% Confidence Interval|Median
2808974|NCT00459342|Primary|Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))|Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.|12 weeks|Of the 34 eligible study participants enrolled, four participants were not evaluable for response.|||participants|||Number
2808975|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24|Immunogenicity was assessed by the number of participants with protective levels of antibody (titers greater than or equal to 1:128)|At Step 3 Weeks 4 and 24 post-booster vaccine|"Participants with data for Step 3 weeks 4 and 24. The numbers for Group 1 (1-dose), Group 1 (2-dose), and Group 3 respectively are:~Week 4: 73, 71, 37 Week 24: 73, 70, 33"|||participants|||Number
2808976|NCT00459316|Secondary|Safety, as Assessed by Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Step 3 Dose of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of vaccination at Step 3 entry through 6 weeks post-vaccination|All participants who were vaccinated at Step 3 entry|||participants|||Number
2808977|NCT00459316|Secondary|Immunologic Memory or Primary Response for Serogroup C by Treatment Arm|"Immunologic Memory defined as:~Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or~Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7.~Primary Response defined as:~A four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; or~A change from titer <1:128 on day 0 to titer ≥1:128on day 28, but not between day 0 and day 7."|At Week 4 post-booster vaccination|Group 1 participants who entered Step 3|||participants|||Number
2808978|NCT00459316|Secondary|Immunologic Memory for Serogroup C by Treatment Arm (1 vs. 2 Doses)|"Evidence of immunologic memory according to each of the following definitions:~Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or~Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7."|At Week 1 post-booster vaccination|Participants in Group 1 who entered Step 3|||participants|||Number
2808979|NCT00459316|Secondary|Number of Participants With Protective Antibody Titers for Serogroup C at Step 3 Entry|Number of participants with protective antibody titers (rSBA>=1:128) for serogroup C by treatment arm (1 vs. 2 doses) of Group 1 (entry CD4% >= 15) at Step 3 entry|At 3.5 years|Group 1 and 3 participants at entry to Step 3|||participants|||Number
2808980|NCT00459316|Secondary|Immunogenic Response to Serogroup C in Group 2|Immunogenic response as assessed by number of participants with protective antibody titers (>= 1:128) to serogroup C in Group 2 (entry CD4%<15)|At Weeks 4, 28, and 72|Group 2 participants with response data for weeks 4, 28 and 72|||participants|||Number
2809018|NCT00459043|Secondary|Progression Free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sumof the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions|3 years||||weeks||95% Confidence Interval|Median
2808981|NCT00459316|Primary|Number of Participants With Primary Response (in Step 3)|Primary response was defined for each serogroup as a four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; OR a change from seronegative on day 0 to seropositive on day 28, but not between day 0 and day 7. Note: a primary response can only occur in the absence of any memory response.|Step 3 entry and Week 4 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.|||participants|||Number
2808982|NCT00459316|Primary|Number of Participants With Seropositive Memory Response (in Step 3)|Seropositive memory response was defined for each serogroup by having protective antibody levels (titer >= 1:128) on Day 0 or change from seronegative to seropositive between booster dose (Day 0) and Day 7.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.|||participants|||Number
2808983|NCT00459316|Primary|Number of Participants With 4-fold Memory Response in Step 3|Defined for each serogroup as a four-fold rise in antibody titers between booster dose (week 0) and week 1.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.|||participants|||Number
2808984|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Entry|Immunogenicity was assessed for each serogroup by the number of participants with protective antibody levels (titers greater than or equal to 1:128)|At 3.5 years (Step 3 entry)|All participants who had antibody data for Step 3 Week 0|||participants|||Number
2808985|NCT00459316|Primary|Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 2 at week 24 to 6 weeks post-vaccination|All participants who entered Step 2|||participants|||Number
2808986|NCT00459316|Primary|Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 1 at week 0 to 42 days post-vaccination|All participants who received Dose 1.|||participants|||Number
2808987|NCT00459316|Primary|Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72|Protective levels of antibody are titers ≥1:128.|Week 72|"Participants with antibody data at Week 72. The number of Participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:~serogroup A are 82, 108, 18, 44 serogroup C are 78, 110, 16, 44 serogroup W-135 are 80, 110, 17, 44 serogroup Y are 82, 110, 18, 44"|||participants|||Number
2808988|NCT00459316|Primary|Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline)|Serum bactericidal antibody titers were measured at study entry and Week 4 for each of the four serogroups in the MCV-4 vaccine. Response (seroconversion) was defined as a 4-fold or greater increase from entry at Week 4.|At Study entry, Week 4|"This outcome only includes participants who had antibody data from both entry and Week 4.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:~serogroup A are 93, 129, 20, 49 serogroup C are 90, 130, 18, 49 serogroup W-135 are 91, 131, 19, 49 serogroup Y are 93, 131, 20, 49"|||participants|||Number
2808989|NCT00459316|Primary|Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4.|Serum bactericidal antibody titers were measured at study entry and Week 28 for each of the four serogroups in the MCV-4 vaccine. Response was defined as a 4-fold or greater increase from entry at Week 28.|Study entry and Week 28|"This outcome only includes participants who received 2 doses and had antibody data from both entry and Week 28.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 are respectively:~serogroup A: 49, 63, 20, 49 serogroup C: 47, 65, 18, 49 serogroup W-135: 47, 66, 19, 49 serogroup Y: 49, 66, 19, 49"|||participants|||Number
2808990|NCT00459303|Primary|Best Corrected Contrast Sensitivity in Photopic Condition|"Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the EYEVIEW™ Functional Analysis Software into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements.~( physiological range of contrast sensitivity: 1.5 cpd : 25~82.5 ; 3 cpd: 30~150 ; 6 cpd: 65 ~ 200 ; 12 cpd: 20 ~130 ; 18 cpd: 6.5 ~ 65 )"|average data of post-operative 3rd week, 6th week, 12th week measurements||||units on a scale||Standard Deviation|Mean
2808991|NCT00459303|Secondary|Total Ocular High-order Aberrations|A Hartmann-Shack aberrometer (Zywave, Bausch & Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm.|average data of post-op 3rd, 6th, 12th week measurements||||μm||Standard Deviation|Mean
2808992|NCT00459303|Secondary|Corneal High-order Aberrations|Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were described with Zernike polynomials of 3rd- to 5th-order root-mean-square (RMS) of central 6mm diameter using VOLPro 6.89 software (Fa. Sarver and Associates, Carbondale. Ill, USA).|pre-op & averate data of post-op 3rd, 6th, 12th week measurements||||μm||Standard Deviation|Mean
2808993|NCT00459303|Primary|Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition|Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.|average data of post-op 3rd, 6th, 12th week measurements|"we obtained data and calculated the probable sample size needed from the following reference papers:~Ophthalmologe 2005 Jan;102(1):51-7.~Acta Ophthalmol Scand 2004;82(6):718-22."|||log MAR||Standard Deviation|Mean
2808994|NCT00459290|Secondary|Progression-free Survival by Age (y)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
2808995|NCT00459290|Secondary|Progression-free Survival by Performance Status||Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
2808996|NCT00459290|Secondary|Progression-free Survival by Platinum Sensitivity|Platinum Senstive defined as treatment free interval >6 months on most recent platinum|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants with treatment free interval available|||months||95% Confidence Interval|Median
2808997|NCT00459290|Secondary|Overall Survival||Five years|Eligible and treated participants|||months||95% Confidence Interval|Median
2808998|NCT00459290|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
2808999|NCT00459290|Primary|Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Every cycle, during treatment (average of 3 months).|Eligible and treated patients|||Participants|||Count of Participants
2809000|NCT00459290|Primary|Proportion of Patients With Objective Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||percentage of participants||95% Confidence Interval|Number
2809001|NCT00459290|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||percentage of participants||95% Confidence Interval|Number
2809016|NCT00459056|Primary|Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)|Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.|Change from three months to seven months|All completers were included in the analysis|||Ratio||Standard Deviation|Mean
2809017|NCT00459043|Secondary|Overall Survival||3 years||||weeks||95% Confidence Interval|Median
2809002|NCT00459186|Secondary|Response Based on PET Scan|Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%.|10 to 14 days after study entry|All patients receiving at least one dose of RAD001|||percentage of participants||90% Confidence Interval|Number
2809003|NCT00459186|Primary|Number of Patients Free of Dose Limiting Toxicity|"A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:~Hematologic Toxicity:~CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days~Non-hematologic toxicity:~The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:~CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.~CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)~CTCAE grade 3 or 4 alkaline phosphatase."|21 days|Patients who received combination treatment with RAD001 + Docetaxel|||participants|||Number
2809004|NCT00459134|Secondary|Quality of Life|Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.|12 weeks|Participants who filled out the FACT-G at any time|||units on a scale||Standard Error|Least Squares Mean
2809005|NCT00459134|Primary|Sexual Function|Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.|12 weeks|Participants who filled out the FSFI at any time|||units on a scale||Standard Error|Least Squares Mean
2809006|NCT00459121|Secondary|Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.|Evaluation of the number of patients who have no evidence of tumor in the resected tumor.|30 days post surgery|No analysis was completed only 2 patients enrolled, study closed due to slow accrual.||||||
2809007|NCT00459121|Secondary|Assess the Clinical Response Rate of the Proposed Pre-operative Regimen|Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy|End of three cycles of treatment|No analysis was completed only 2 patients enrolled, study closed due to slow accrual.||||||
2809008|NCT00459121|Secondary|Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy|Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT [AST], SGPT [ALT], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.|Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel|No analysis was completed only 2 patients enrolled, study closed due to slow accrual.||||||
2809009|NCT00459121|Secondary|Post-Operative Mortality Rate||at 30 days|No analysis was completed only 2 patients enrolled, study closed due to slow accrual.||||||
2809010|NCT00459121|Primary|Complete Resection (R0) Rate||Following three cycles of pre-operative zactima and carboplatin/paclitaxel|No analysis was completed only 2 patients enrolled, study closed due to slow accrual.||||||
2809011|NCT00459108|Secondary|Safety and Tolerability|Summarize observed grade 3 and higher toxicities related to dasatanib. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were used for reporting.|Up to 4 years|One patient died due to underlying cardiac disease which may have been exacerbated by the dasatanib.|||participants|||Number
2809012|NCT00459108|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 4 years||||Months||95% Confidence Interval|Median
2809013|NCT00459108|Secondary|Median Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death, up to 4 years||||Months||95% Confidence Interval|Median
2809014|NCT00459108|Primary|Four Month Progression-free Survival (PFS)|Progression-free survival calculated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months||||percentage of participants||95% Confidence Interval|Number
2809015|NCT00459108|Primary|Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR|4 months||||percentage of responding patients|||Number
2809019|NCT00459043|Primary|Partial Response Rate in Both Groups of Patients.|Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR|3 years|29 patients were analyzable|||percentage of participants||95% Confidence Interval|Number
2809020|NCT00458952|Primary|MTD of Ultratrace Iobenguane I 131|Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.|6 weeks post therapy dose|24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.|||mCi/kg|||Number
2809021|NCT00458848|Secondary|Percentage of Participants Reaching Overall Survival|Overall survival from diagnosis|At 60 months||||percentage of patients|||Number
2809022|NCT00458848|Secondary|Number of Patients Reaching Complete Hematological Response After Induction Therapy||At the end of induction, day +50||||participants|||Number
2809023|NCT00458848|Primary|Percentage of Participants Reaching Disease Free Survival||At 60 months||||percentage of participants|||Number
2809024|NCT00458822|Primary|Hematologic and Organ Response|patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.|2-3 months post transplant||||participants|||Number
2809025|NCT00458705|Primary|Disease Response|The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.|2 years||||participants|||Number
2809026|NCT00458536|Secondary|to Correlate Immunologic Response Following Vaccination.||5 years|||||||
2809027|NCT00458536|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF||5 years|||||||
2809028|NCT00458536|Primary|Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF||5 years|Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions.|||participants|||Number
2809029|NCT00458406|Secondary|Pediatric Quality of Life (PedQL)|Change in quality of life from baseline to 3 months|3 months|The data for BiFlex and CPAP arms are not available for this Outcome Measure since the original PI for the study is deceased. Limited data are available for the study results||||||
2809030|NCT00458406|Secondary|Change in NOSE Scale Score From Month 1 to Month 3|Change in the total Nasal Obstruction Symptom Evaluation (NOSE) scale score (Score at Month 3 minus Score at Month 1). This scale evaluates the severity of nasal obstructive symptoms. The scale ranges from 0-20, with a higher score indicating more nasal obstruction.|3 months||||units on a scale||Standard Deviation|Mean
2809031|NCT00458406|Secondary|Change in ESS From Month 1 to Month 3|Change in the Epworth Sleepiness Scale (ESS) score from Month 1 to Month 3: (Score at Month 3 minus Score at Month 1). The ESS measures daytime sleepiness in certain situations e.g. sitting/reading, watching television, sitting inactive in public, as a passenger in a car for an hour without a break, lying down to rest in the afternoon when circumstances permit, sitting/talking with someone, sitting quietly after lunch, or in a car, while stopped for a few minutes in traffic. The scale ranges from a minimum of zero to 24, with higher scores indicating greater daytime sleepiness.|3 months||||units on a scale||Standard Deviation|Mean
2809032|NCT00458406|Secondary|Obstructive Sleep Apnea (OSA) 18 Score|Polysomnographic measurements of sleep quality using the OSA 18 score at 3 months|3 months|The data for BiFlex and CPAP arms are not available for this Outcome Measure since the original PI for the study is deceased. Limited data are available for the study results||||||
2809033|NCT00458406|Secondary|Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3|Change in Apnea Hypopnea Index from Month 1 to Month 3. AHI at Month 3 minus AHI at Month 1.|3 months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||Apneas and Hypopneas/hr sleep||Full Range|Median
2809034|NCT00458406|Secondary|Drop Out Rate|Number of drop-outs included subjects in which investigators were unable to obtain a final download from the device.|3 months|Power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||participants|||Number
2809035|NCT00458406|Primary|Change in Minutes of Use Per Night From Month 1 to Month 3|minutes of use per night at Month 3 minus minutes of use per night at Month 1|month 1, month 3||||minutes||Standard Deviation|Mean
2809036|NCT00458406|Primary|Minutes of Use Per Night at Month 3|The number of minutes of use per night at Month 3.|3 Months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||minutes||Standard Deviation|Mean
2809037|NCT00458406|Primary|Minutes of Use Per Night at Month 1|The number of minutes of use per night at month 1.|1 month|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|||minutes||Standard Deviation|Mean
2817682|NCT00399542|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809040|NCT00458393|Secondary|Incidence of Confirmed Syphilis During Follow-Up|Number of participants who have at least 1 confirmed syphilis infection during the study|All Follow-Up median of 1.2 years of follow-up|Participants without active syphilis at baseline with a follow-up syphilis test.|||Participants|||Count of Participants
2809041|NCT00458393|Secondary|Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.|Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.|At 24 weeks|Participants interviewed about sexual practices at week 24|||Participants|||Count of Participants
2809042|NCT00458393|Secondary|Total Number of Sexual Partners|Self-reported total number of sexual partners in the previous 12 weeks.|24 weeks|Participants interviewed about sexual practices at week 24|||Count||Inter-Quartile Range|Median
2809043|NCT00458393|Secondary|Number of Condomless Sexual Partners With HIV Positive or Unknown Status|Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex|At 24 weeks|Participants interviewed about sexual practices at week 24|||count||Inter-Quartile Range|Median
2809044|NCT00458393|Secondary|Percentage of Missed Doses by Estimate During CASI Interview|Percentage of missed doses by estimate during computer assisted structured interview|Week 24|All participants who answered the adherence question with an estimated adherence on the week 24 computer assisted structured interview|||percentage of doses taken||Standard Error|Mean
2809045|NCT00458393|Secondary|Proportion of Missed Doses by Pill Count|Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)|At 24 weeks|Those who bottles returned at the week 24 visit.|||proportion of pills not returned||95% Confidence Interval|Mean
2809046|NCT00458393|Secondary|CD4 Count Among HIV Infected Participants|CD4 cell count for HIV infected participants during the trial|at the time infection was detected|HIV infected participants during the trial including those HIV+ at baseline|||cells per cubic mm||95% Confidence Interval|Mean
2809047|NCT00458393|Secondary|Among HIV Infected Participants Drug Resistance|Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period|at the time of HIV acquisition|There were 2 TDF/FTC seroconversions at enrollment and 48 during follow-up. There were 8 Placebo seroconversions at enrollment and 83 during follow-up.|||Participants|||Count of Participants
2809048|NCT00458393|Secondary|Viral Load Among HIV Infected Participants|HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection|At the time closest to HIV detection|All HIV infections detected during the study including prior to, during and after study treatment|||log RNA copies per ml||Standard Error|Mean
2809049|NCT00458393|Secondary|Percent Change in Total Cholesterol|Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline|Baseline and Week 24|All participants in the metabolic substudy with a week 24 fasting cholesterol|||percent change from baseline||Standard Error|Median
2809050|NCT00458393|Secondary|Percentage Change in Fasting Triglycerides|Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample.|Baseline and Week 24|All participants in the metabolic substudy with a week 24 fast triglyceride value|||percent change from baseline||Standard Error|Median
2809051|NCT00458393|Secondary|Percentage Change in Body Fat|Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry|Baseline and Week 24|All participants in the body composition substudy who made a week 24 body scan|||percent change from baseline||Standard Error|Median
2809052|NCT00458393|Secondary|Percentage Change in Bone Mineral Density|% Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry|baseline and week 24.|Participants confirmed to be HIV negative at enrollment who consented to participate in the metabolic substudy. Full details in https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25908682/|||percent change from baseline||Standard Error|Mean
2809053|NCT00458393|Secondary|Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis|"A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.~More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/"|Quarterly lab tests through a median follow-up of 1.2 years|Those with chronic active hepatitis B at enrollment.|||Participants|||Count of Participants
2809054|NCT00458393|Primary|Grade 2, 3, or 4 Clinical Adverse Events|Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf|Entire follow-up, median 1.2 years|At participants with at least one follow-up visit|||Participants|||Count of Participants
2809055|NCT00458393|Primary|Grade 2, 3, or 4 Laboratory Adverse Events|Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf|Entire follow-up, median 1.2 years|At participants with at least one visit with laboratory values post-baseline|||Participants|||Count of Participants
2809056|NCT00458393|Primary|Grade 3 or Higher Phosphorous Toxicity|Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)|The entire follow-up period, median 1.2 years|All participants with at least 1 follow-up phosphorus value|||Participants|||Count of Participants
2809057|NCT00458393|Primary|Grade 1 or Higher Creatinine Toxicity|Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf|Duration of follow-up, median 1.2 years|All randomized participants which at least 1 follow-up creatinine value|||Participants|||Count of Participants
2820646|NCT00379808|Other Pre-specified|Triglycerides|measured by a clinical laboratory; Quest Laboratories|1 month|those completing the entire study|||mg/dl||Inter-Quartile Range|Median
2809059|NCT00458341|Secondary|Compliance With Study Treatment|"For each participant, compliance was described in terms of the percentage of drug actually taken relative to the amount that was prescribed (taking into account physician-prescribed reductions and interruptions). The number of doses described as taken less than planned includes cases in which the participants took less than the prescribed dose and/or cases in which the Investigator reduced the dose."|Baseline up to Day 14 in Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of study drug and had evaluable compliance data. The data for each dose level represents pooled data for participants in the low-to-high dose sequence and the high-to-low dose sequence.|||percentage of doses||Full Range|Median
2809060|NCT00458341|Secondary|PK: Area Under the Concentration Time Curve From Time 0 (Dosing) to 24 Hours (AUC0-24) of Ataluren|All PK parameters were calculated using the actual postdose blood sampling times in relationship to the time of the first dose (morning dose) on Day 14 of each treatment cycle. AUC0-24 values were calculated by WinNonlin by extrapolation to 24 hours if the last sampling timepoint was before 24 hours and by interpolation if the last sampling timepoint was after 24 hours. Extrapolation of AUC to 24 hours was performed only if the last sampling timepoint did not deviate from the nominal collection time by more than approximately 10%.|0 (predose), 2 and 3 hours postdose of the morning dose; 0 (predose), 2 and 3 hours postdose of the midday dose; and 0 hours (predose), 2, 3, and 12 hours postdose of the evening dose on Day 14 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of study drug and had evaluable AUC0-24 data. The data for each dose level represents pooled data for participants in the low-to-high dose sequence and the high-to-low dose sequence.|||microgram*hours/milliliter (μg*h/mL)||Standard Error|Mean
2809061|NCT00458341|Secondary|Change From Baseline in the CF-Related Symptom Scores, as Assessed Using a Participant-Reported Questionnaire at Day 14 of Cycles 1 and 2 and Overall Day 56|The CF symptom questionnaire includes questions related to daytime cough, nighttime cough, sputum volume, sputum clearance, physical fatigue, and shortness of breath. The participants (or their guardians) completed the CF symptom questionnaire, under the Investigator's supervision, before the TEPD, nasal mucosal curettage, pulmonary function tests, or sputum induction procedures were performed. For each symptom, the participants were asked to choose the response that best matched their experience during the 3 days before the questionnaire was completed. The scale of the 4 possible responses for each question was 0 (best response) to 4 (worse response). The sum of the scores for all of the questions was calculated. The scale for the sum of the scores was 0 (best response) to 24 (worse response). Overall Baseline data for the study and change from overall Baseline data at Day 14 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable CF-related symptom scores.|||scores on a scale||Full Range|Median
2809062|NCT00458341|Secondary|Change From Baseline in Body Weight at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|Body weight were measured for each participant in kilograms (kg). Overall Baseline data for the study and change from overall Baseline data at Day 14 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable body weight data.|||kg||Standard Deviation|Mean
2809063|NCT00458341|Secondary|Change From Baseline in Clinically Significant Serum Levels of C-Reactive Protein at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|To assess inflammatory markers in the blood, serum levels of C-reactive protein were measured. Higher levels of C-reactive protein are indicative of more inflammation. Change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable serum levels of C-reactive data.|||milligrams/liter (mg/L)||Standard Deviation|Mean
2809064|NCT00458341|Secondary|Change From Baseline in Clinically Significant Neutrophil Levels in Blood at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|To assess inflammatory markers in the blood, neutrophil levels in the blood were measured. Higher levels of neutrophils are indicative of more inflammation. Change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable data of neutrophil levels in blood.|||10^9/liters||Standard Deviation|Mean
2809065|NCT00458341|Secondary|Change From Baseline in Sputum Markers of Inflammation (Uridine-5'-Triphosphate [UTP]) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|The inflammatory marker UTP was measured in induced sputum from each participant. Hypertonic saline (3%) inhalation was used to induce the sputum (with efforts made to avoid oropharyngeal contamination). The sputum sample was divided into 4 aliquots (1 aliquot each for determination of cell count, IL-8 level, and elastase activity and 1 aliquot for potential future viscosity measurements). Change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
2809066|NCT00458341|Secondary|Change From Baseline in Sputum Markers of Inflammation (Tumor Necrosis Factor-Alpha [TNF-α], Interleukin-8 [IL-8], Transforming Growth Factor Beta 1 [TGF-β1]) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|The inflammatory markers TNF-α, IL-8, and TGF-β1 were measured in induced sputum from each participant. Hypertonic saline (3%) inhalation was used to induce the sputum (with efforts made to avoid oropharyngeal contamination). The sputum sample was divided into 4 aliquots (1 aliquot each for determination of cell count, IL-8 level, and elastase activity and 1 aliquot for potential future viscosity measurements). Change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data.|||picograms/milliliter (pg/mL)||Standard Deviation|Mean
2809106|NCT00458211|Primary|Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia|Minimum score 32 (best) maximum 210 (worst)|Baseline to 8 weeks|The four Rochester subjects were dropped as Rochester could not continue the study.19 Bronx and 17 Buffalo subjects were analyzed separately because they were so different(see baseline characteristics)|||score on scale||Standard Deviation|Mean
2809067|NCT00458341|Secondary|Change From Baseline in Sputum Markers of Inflammation (Matrix Metalloproteinase 9 [MMP-9] Active) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|The inflammatory marker MMP-9 active was measured in induced sputum from each participant. Hypertonic saline (3%) inhalation was used to induce the sputum (with efforts made to avoid oropharyngeal contamination). The sputum sample was divided into 4 aliquots (1 aliquot each for determination of cell count, IL-8 level, and elastase activity and 1 aliquot for potential future viscosity measurements). Change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2809068|NCT00458341|Secondary|Change From Baseline in Sputum Markers of Inflammation (Free Elastase) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|The inflammatory marker free elastase was measured in induced sputum from each participant. Hypertonic saline (3%) inhalation was used to induce the sputum (with efforts made to avoid oropharyngeal contamination). The sputum sample was divided into 4 aliquots (1 aliquot each for determination of cell count, IL-8 level, and elastase activity and 1 aliquot for potential future viscosity measurements). Change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data.|||micrograms/milliliters (μg/mL)||Standard Deviation|Mean
2809069|NCT00458341|Secondary|Change From Baseline in Pulmonary Function as Measured by Spirometry at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56|Pulmonary function tests, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow25-75 (FEF25-75), were measured using standard spirometry techniques. Overall Baseline data for the study and change from overall Baseline data at Day 14 or 15 of Cycles 1 and 2 and at overall Day 56 are presented.|Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable pulmonary function data.|||percent of predicted||Standard Deviation|Mean
2809070|NCT00458341|Secondary|Change From Baseline in Nonsense Mutation CFTR mRNA in Nasal Mucosa as Determined by Quantitative Real-Time Polymerase Chain Reaction (RT-PCR) Assay at Overall Day 42|The collection and processing of the nasal mucosal curettage from each nostril of each participant for measurement of CFTR protein by immunofluorescence and for quantification of CFTR messenger ribonucleic acid (mRNA) was performed using standardized techniques. The slides were processed and immunostained for detection of CFTR protein. Microscopic images were to be captured photographically for analysis. Because the nasal brushing used to collect nasal mucosal epithelial cells did not result in collection of sufficient cells for RT-PCR to be performed, an insufficient number of paired baseline and follow-up samples were available for analysis. As a result, no data were available to evaluate the effects of ataluren on CFTR mRNA.|Overall Baseline, Overall Day 42|All randomized participants who received at least 1 dose of study drug and had evaluable CFTR mRNA data.||||||
2809071|NCT00458341|Secondary|Change From Baseline in CFTR Protein in Nasal Mucosa as Determined by Immunofluorescence at Overall Day 56|The immunofluorescence staining of normal epithelial cells (for example, from nasal mucosal curettage) reveals the presence of cystic fibrosis transmembrane regulator (CFTR) protein at the apical surface. Cells were stained with antibodies that recognized an epitope in the C-terminal portion of the CFTR protein, and the cells were imaged microscopically. The percentage of epithelial cells that showed apical CFTR staining was determined by 2 expert readers who were blinded to the timepoint at which the samples were obtained. The scores of the reviewers were averaged to determine the final percentage of cells with apical CFTR. Overall Baseline data for the study and change from overall Baseline data at overall Day 56 are presented.|Overall Baseline, Overall Day 56|All randomized participants who received at least 1 dose of study drug and had evaluable apical cell data.|||percentage of apical cells||Standard Deviation|Mean
2809072|NCT00458341|Secondary|Change From Baseline in Parameters of Transepithelial Difference at Day 14 of Cycles 1 and 2|To assess TEPD, warmed solutions of Ringer's solution, amiloride, chloride-free gluconate, isoproterenol and ATP were perfused for ≥3-minutes sequentially through a nasal catheter while a voltage tracing was recorded. Total chloride transport was computed per nostril. Totals were calculated by subtracting voltages at end of perfusion from voltage at end of earlier perfusion for: sodium transport (amiloride-Ringer's solution), intrinsic chloride transport (chloride-free gluconate-amiloride), stimulated chloride transport (isoproterenol-chloride-free gluconate), total potential difference (isoproterenol-Ringer's solution), and ATP-mediated chloride transport (ATP-isoproterenol). Basal potential difference voltage was obtained at end of Ringer's solution perfusion. Average values per nostril were computed. If assessment was available in only 1 nostril, the value was used as if it's the average of both nostrils. Baseline data for Cycles 1 and 2 and change from Baseline data are presented.|Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)|All randomized participants who received at least 1 dose of study drug and had evaluable transepithelial difference data.|||mV||Standard Deviation|Mean
2809073|NCT00458341|Primary|Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2|Nasal TEPD was assessed in each participant using standardized techniques. Warmed solutions of Ringer's solution, amiloride, chloride-free gluconate, isoproterenol, and ATP were perfused for ≥3-minute sequentially through a nasal catheter while a voltage tracing was recorded. Total chloride transport was computed for each nostril. The total chloride transport values were calculated by subtracting the voltages at the end of a perfusion from the voltage at the end of an earlier perfusion (isoproterenol - amiloride). The average of the values for each nostril was computed. If the assessment was available in only 1 nostril, this value was used as if it were the average of both nostrils. Normalization of chloride transport (normal range [NR]) was defined as nasal TEPD that was at least as electrically negative as -5 mV. Normalization in chloride transport can also be referred to as hyperpolarization.|Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)|All randomized participants who received at least 1 dose of study drug and had evaluable normalization of chloride transport data.|||Participants|||Count of Participants
2809107|NCT00457977|Secondary|Serotype-specific Immunoglobulin G (IgG) Antibody Levels|Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.|||ug/ml||95% Confidence Interval|Geometric Mean
2809074|NCT00458341|Primary|Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2|Nasal TEPD was assessed in each participant using standardized techniques. Warmed solutions of Ringer's solution, amiloride, chloride-free gluconate, isoproterenol, and ATP were perfused for ≥3-minute sequentially through a nasal catheter while a voltage tracing was recorded. Total chloride transport was computed for each nostril. The total chloride transport values were calculated by subtracting the voltages at the end of a perfusion from the voltage at the end of an earlier perfusion (isoproterenol - amiloride). The average of the values for each nostril was computed. If the assessment was available in only 1 nostril, this value was used as if it were the average of both nostrils. Response to study treatment defined as an increase in total chloride transport as indicated by a change of at least -5 mV in nasal TEPD.|Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)|All randomized participants who received at least 1 dose of study drug and had evaluable chloride transport response data.|||Participants|||Count of Participants
2809075|NCT00458341|Primary|Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2|Nasal transepithelial potential difference (TEPD) was assessed in each participant using standardized techniques. Warmed solutions of Ringer's solution, amiloride, chloride-free gluconate, isoproterenol, and adenosine triphosphate (ATP) were perfused for ≥3-minute sequentially through a nasal catheter while a voltage tracing was recorded. Total chloride transport was computed for each nostril. The total chloride transport values were calculated by subtracting the voltages at the end of a perfusion from the voltage at the end of an earlier perfusion (isoproterenol - amiloride). The average of the values for each nostril was computed. If the assessment was available in only 1 nostril, this value was used as if it were the average of both nostrils. Baseline data for Cycle 1 and Cycle 2 and change from Baseline data at Day 14 of Cycles 1 and 2 are presented.|Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)|All randomized participants who received at least 1 dose of study drug and had evaluable chloride transport data.|||millivolts (mV)||Standard Deviation|Mean
2809076|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale|The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
2809077|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale|The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
2809078|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale|The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
2809079|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale|The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
2809080|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale|The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
2809081|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score|The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.|||points on a scale||Standard Error|Mean
2809082|NCT00458302|Secondary|Resistance Determinations|Number of patients with resistance mutations at any time point when a patient had a viral load > 50 copies/mL after randomization.|at each visit from baseline to week 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.|||number of participants|||Number
2809083|NCT00458302|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144|ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol|||number of cells/L (x10^6)||Standard Error|Mean
2809084|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|week 144|PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.|||Participants|||Number
2809108|NCT00457977|Primary|Serotype Opsonization Titers|Opsonophagocytosis activity (OPK) serotype specific geometric means|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.|||titers||95% Confidence Interval|Geometric Mean
2809085|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.|Week 144|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.|||participants|||Number
2809086|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|Week 144|PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.|||participants|||Number
2809087|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window|Week 48|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.|||participants|||Number
2809088|NCT00458302|Primary|Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 48|Week 48|PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.|||participants|||Number
2809089|NCT00458237|Secondary|Clinical Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall clinical response defined as achieving stable disease (SD), partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response. SD is neither CR/PR or progressive disease (PD). PD is at least a 20% increase in sum LD, takings as reference smallest sum LD since treatment started.|Disease assessments occurred every 9 weeks (3 cycles) on treatment. Treatment continued until disease progression or unacceptable toxicity. Median duration of treatment was 2.4 months.|The analysis dataset is comprised of patients treated at the MTD/dose level 2.|||proportion of participants||90% Confidence Interval|Number
2809090|NCT00458237|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):~Any grade 4 hematologic toxicity, excluding anemia.~Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.~Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity."|Cycle One (first 21 days of treatment)|The analysis dataset for the Phase I study is comprised of the two dose cohorts: Level 1 and 2.|||participants with DLT|||Number
2809091|NCT00458211|Secondary|Antipsychotic Medication Costs||8 weeks|||||||
2809092|NCT00458211|Secondary|Insulin Level||8 weeks|||||||
2809093|NCT00458211|Secondary|HgbA1c||8 weeks|||||||
2809094|NCT00458211|Secondary|Barnes Akathisia Scale||8 weeks|||||||
2809095|NCT00458211|Secondary|MOS-COG||8 weeks|||||||
2809096|NCT00458211|Secondary|PETiT||8 weeks|||||||
2809097|NCT00458211|Secondary|CDSS||8 weeks|||||||
2809098|NCT00458211|Secondary|BACS||8 weeks|||||||
2809099|NCT00458211|Secondary|QTc|Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous|8 weeks||||msec||Standard Deviation|Mean
2809100|NCT00458211|Secondary|Simpson-Angus Scale Measures Drug Induced Parkinsonism|Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.|8 weeks|see PANNS above|||score on scale||Standard Deviation|Mean
2809101|NCT00458211|Secondary|Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia|Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28|8 weeks|17 Buffalo subjects and 19 Bronx subjects|||score on scale||Standard Deviation|Mean
2809102|NCT00458211|Secondary|Cholesterol||8 weeks|See PANSS above|||mg/dL||Standard Deviation|Mean
2809103|NCT00458211|Secondary|Fasting Glucose||8 weeks|See PANNS above|||mg/dl||Standard Deviation|Mean
2809104|NCT00458211|Secondary|Weight||8 weeks|Same as PANNS above|||pounds||Standard Deviation|Mean
2809105|NCT00458211|Secondary|Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.|CGI-S scores from 1 = normal to 7 = most extremely ill|8 weeks|17 Buffalo subjects and 19 Bronx subjects|||score on scale||Standard Deviation|Mean
2809109|NCT00457951|Primary|Incidence of Treatment Failure|"The primary outcome of the study is Treatment Failure as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital."|Time to hospital discharge and 21 days post-treatment, up to 31 days|Of the 138 subjects randomized, 132 were analyzed in the intent-to-treat population. Of the 6 excluded from the intent-to-treat population, 4 did not receive study drug and 2 lacked information for assessment.|||percentage of failures||95% Confidence Interval|Number
2809110|NCT00457821|Primary|Number of Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||events|||Number
2809111|NCT00457821|Secondary|Change From Baseline in Maximum Sweat Chloride Concentration (Combined Part 1 and Part 2)|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.|||millimoles per liter||95% Confidence Interval|Least Squares Mean
2809112|NCT00457821|Secondary|Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|14 days and 28 days|Part 2 is a parallel study. Subjects were counted only once for each treatment group.|||score on a scale||Standard Deviation|Mean
2809113|NCT00457821|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)|"Spirometry is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.~Relative change reflects the percent change from the baseline values [100% * (X-Y)/Y], where X and Y are post-baseline and baseline values, respectively."|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.|||percent predicted (%)||95% Confidence Interval|Least Squares Mean
2809114|NCT00457821|Secondary|Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)|The transepithelial nasal potential difference (NPD) is a direct measure of transepithelial ion transport. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol was of primary interest.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.|||millivolts||95% Confidence Interval|Least Squares Mean
2809115|NCT00457821|Primary|Number of Subjects With Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||participants|||Number
2809116|NCT00457795|Secondary|Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4|Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2809117|NCT00457795|Secondary|Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4|Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2809118|NCT00457795|Secondary|Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.|Baseline, Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2809119|NCT00457795|Primary|Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2809146|NCT00457730|Primary|Percent Change in Worst Pain Score|Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6||||percent reduction on 0-10 analog scale||Standard Deviation|Mean
2817683|NCT00399542|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809120|NCT00457743|Secondary|Overall Survival Time|"Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive.~Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once."|From the first dose to death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
2809121|NCT00457743|Secondary|Time To Failure (TTF)|Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
2809122|NCT00457743|Primary|Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group|Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
2809123|NCT00457743|Primary|Accumulation Ratio (Rac) on Cycle 1 Day 28|"Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1.~Rac was the ratio of Day 28 to Day 1."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||ratio||Standard Deviation|Mean
2809124|NCT00457743|Primary|SU-011248 Clearance on Cycle 1 Day 28|"SU-011248 Clearance in the subjects enrolled in Phase 1.~Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||L/h||Standard Deviation|Mean
2809125|NCT00457743|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.|From the first dose to Progressive Disease or Death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
2809126|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||hours||Full Range|Median
2809127|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.|||hours||Full Range|Median
2809128|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued the dose on Cycle1, therefore no data showed."|||ng•h/mL||Standard Deviation|Mean
2809129|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.|||ng•h/mL||Standard Deviation|Mean
2809130|NCT00457743|Secondary|Time To Tumor Progression (TTP)|Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).|From the first dose to Progressive Disease|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
2809131|NCT00457743|Secondary|Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|ITT population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
2809161|NCT00457418|Primary|Minimum Serum Concentration (Cmin) of PEG-Intron at 12 Weeks|Cmin was defined as observed minimum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 19 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification and there was no concentration data for 1 participant at Week 12).|||pg/mL||Standard Deviation|Mean
2809132|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."|||ng/mL||Standard Deviation|Mean
2809133|NCT00457743|Secondary|Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
2809134|NCT00457743|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires|"The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health.~Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline"|Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n= Number of subjects with analyzable data."|||index scores on a scale||Standard Deviation|Mean
2809135|NCT00457743|Secondary|Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires|"Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A).~The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated.~Change from Baseline: Score at each observation minus score at baseline"|Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n= Number of subjects with analyzable data."|||scores on a scale||Standard Deviation|Mean
2809136|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."|||ng/mL||Standard Deviation|Mean
2809137|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-012262|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."|||ng/mL||Standard Deviation|Mean
2809138|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."|||ng/mL||Standard Deviation|Mean
2809139|NCT00457743|Secondary|Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)|Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."|||pg/mL||Standard Deviation|Mean
2809140|NCT00457743|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."|||pg/mL||Standard Deviation|Mean
2809141|NCT00457743|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."|||pg/mL||Standard Deviation|Mean
2809142|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2809143|NCT00457743|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.|Cycle 1 (Baseline to Week 6)|DLT analysis population consists of subjects who developed DLT or received 85% of the planned dose. One subject in 75-mg dose group was excluded from DLT analysis population because the subject received less than 85% of the planned dose.|||participants|||Number
2809144|NCT00457730|Secondary|Global Impression of Change|"global impression: How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible"|Week 6 vs baseline||||units on a scale||Standard Deviation|Mean
2809145|NCT00457730|Secondary|Percent Change in Average Pain Score.|Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6||||percent reduction on 0-10 analog scale||Standard Deviation|Mean
2809147|NCT00457691|Secondary|Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline scores for EQ-VAS were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).|||Scores on a scale||95% Confidence Interval|Mean
2809148|NCT00457691|Secondary|Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire|"EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state."|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The EQ-5D health state index results were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).|||Scores on a scale||95% Confidence Interval|Mean
2809149|NCT00457691|Secondary|Change From Baseline in MDASI-GI Symptom Interference Score|Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, 11).|||scores on a scale||95% Confidence Interval|Mean
2809150|NCT00457691|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score|Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, and 11).|||Scores on a scale||95% Confidence Interval|Mean
2809151|NCT00457691|Secondary|Duration of Response (DR)|DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.|Day 28 of Cycle 1 up to 30 months|ITT Population (participants with a confirmed objective tumor response).|||Weeks||95% Confidence Interval|Median
2809152|NCT00457691|Secondary|Number of Participants With Overall Confirmed Objective Response|Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 30 months||||Participants|||Number
2809153|NCT00457691|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.|Baseline up to 30 months|ITT Population.|||Weeks||95% Confidence Interval|Median
2809154|NCT00457691|Primary|Progression-free Survival (PFS)|PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.|First dose of study treatment up to 30 months|Intent-to-treat (ITT) population included all participants who were randomized.|||Weeks||95% Confidence Interval|Median
2809155|NCT00457665|Primary|Effect of Drug Regimens on Serum Triglycerides.||12 and 24 months|Some subjects dropped before 1 year and some dropped between 1-2 years.|||mg/dL||Standard Deviation|Mean
2809156|NCT00457639|Secondary|Serum Triglycerides||Months 6||||mg/dL||Inter-Quartile Range|Median
2809157|NCT00457639|Primary|Hepatic Triglyceride (%)|Measured by proton magnetic resonance spectroscopy (MRS)|6 months||||Fat/Fat+Water (%)||Inter-Quartile Range|Median
2809158|NCT00457418|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) was defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product.|Entire study duration (up to 5 years)||||participants|||Number
2809159|NCT00457418|Primary|Apparent Clearance(CL/F) of PEG-Intron at 12 Weeks|CL/F was defined apparent clearance - the volume of plasma in the vascular compartment cleared of drug per unit of time and per kilogram of body weight by the processes of metabolism and excretion.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 15 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification but for 5 participants CL/F could not be reported because t1/2 could not be accurately determined).|||L/hr/kg||Standard Deviation|Mean
2809160|NCT00457418|Primary|Observed Time to Achieve Cmax (Tmax) of PEG-Intron at 12 Weeks|Tmax was defined as time of maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose).|||hours||Full Range|Median
2809186|NCT00457197|Secondary|Gamma-glutamyltransferase (GGT)|GGT is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.|||IU/I||Standard Error|Least Squares Mean
2809162|NCT00457418|Primary|Average Concentration Within the Dosing Interval (Cavg) of PEG-Intron at 12 Weeks|Cavg was defined as average plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)|||pg/mL||Standard Deviation|Mean
2809163|NCT00457418|Primary|Maximum Serum Concentration (Cmax) of PEG-Intron at 12 Weeks|Cmax was defined as observed maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)|||pg/mL||Standard Deviation|Mean
2809164|NCT00457418|Primary|Area Under the Curve (AUC) of PEG-Intron at 12 Weeks|AUC was defined as the actual body exposure to drug after administration of a dose of the drug.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)|||pg*hr/mL||Standard Deviation|Mean
2809165|NCT00457392|Secondary|EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline and End of Treatment (EOT) or Withdrawal|Patients Reported Outcome (PRO) Analysis Set included participants from the FA population who had at least one EQ-5D assessment while on treatment. The 'n' signifies those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
2809166|NCT00457392|Secondary|One-year Survival Probability|The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate.|Baseline until death or until 28 days after last dose for the last participant|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Percent chance of survival||95% Confidence Interval|Number
2809167|NCT00457392|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline to disease progression or death or discontinuation from study or 28 days after last dose|DR was calculated for the subgroup of participants from the FA set, with a confirmed objective tumor response.|||Weeks||95% Confidence Interval|Median
2809168|NCT00457392|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline to disease progression or discontinuation from study or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2809169|NCT00457392|Secondary|Progression-Free Survival (PFS)|"Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Weeks||95% Confidence Interval|Median
2809170|NCT00457392|Primary|Overall Survival (OS)|Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline to death or 28 days after last dose for the last participant|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2809171|NCT00457366|Primary|Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.|The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).|Two hours|34 patients received the Cocktail, but 4 of these were excluded from the analysis because they had only demographic data and no clinical outcome data. A total of 38 patients received Quetiapine; all were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2809187|NCT00457197|Secondary|Percent of Heavy Drinking Days||12 weeks||||drinks||Standard Error|Least Squares Mean
2809188|NCT00457197|Primary|The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.||12 weeks||||drinks||Standard Error|Least Squares Mean
2809172|NCT00457301|Primary|EuroQol, EQ-5D.|"Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (no problem, some problems and extreme problems).Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable."|At baseline and end of study (6 months).|To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF.|||mean EQ-5D index score||Standard Deviation|Mean
2809173|NCT00457301|Primary|Management Composite|Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.|At baseline and end of study (6 months)|Analysis was conducted using ITT, with 47 observations carried forward.|||mean management composite||Standard Deviation|Mean
2809174|NCT00457301|Secondary|The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.|HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study.|Baseline and end of study (6 months)|47 observation were imputed by LOCF and analyzed as ITT.|||mean anxiety and depression||Standard Deviation|Mean
2809175|NCT00457301|Primary|Communication Score|Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.|Baseline and end of study (6 months)|Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF.|||Mean number of issues discussed||Standard Deviation|Mean
2809176|NCT00457249|Other Pre-specified|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.|Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.|Day 0 up to 14 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.|||Participants|||Number
2809177|NCT00457249|Primary|Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.|Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.|Day 35 post-vaccination|Booster response was assessed in the per-protocol population.|||Percentage of Participants|||Number
2809178|NCT00457249|Primary|Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.|Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.|Day 35 post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
2809179|NCT00457249|Primary|Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine||Day 35 post-vaccination|GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2809180|NCT00457197|Secondary|Penn Alcohol Craving Scale (PACS)|"The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking~Score:~Minimum: 0 Maximum: 30 Lower score associated with better outcome."|12 weeks|Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
2809181|NCT00457197|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks|Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
2809182|NCT00457197|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks|Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
2809183|NCT00457197|Secondary|Hamilton Rating Scale for Depression (HRSD)|"The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).~Scale:~Minimum: 0 Maximum: 50 Lower score associated with better outcome"|12 weeks|Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.|||units on a scale||Standard Error|Least Squares Mean
2809184|NCT00457197|Secondary|Alanine Aminotransferase (ALT)|ALT is a liver enzyme measurement (IU/I).|12 weeks|Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.|||IU/I||Standard Error|Least Squares Mean
2809185|NCT00457197|Secondary|Aspartate Aminotransferase (AST)|AST is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.|||IU/I||Standard Error|Least Squares Mean
2809189|NCT00457015|Secondary|Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours|"Maintenance of significant improvement was defined as achieving and maintaining a significant improvement in overall response through 24 hours after dosing. Patient response categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse."|24 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.|||participants|||Number
2809190|NCT00457015|Secondary|Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score|A successful response was defined as improvement in existing laryngeal symptom complex,stabilization of an existing peripheral symptom complex, or a change from baseline in the MSCS score at 4 hours of at least -1.0.|baseline, 4 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.|||participants|||Number
2809191|NCT00457015|Secondary|Patients With Significant Improvement in Overall Response|"Patients were to be asked to perform an overall response assessment at intervals during the first 4 hours post-dose. Assessments were to be made relative to baseline (ie, immediately before initial dosing) using a 5-category scale. Categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse. Significant improvement is the first time that a patient responded to the overall response assessment as a lot better or resolved."|4 hours post-dose|The time to significant improvement is not provided in this display as the estimated median times were not reached by 240 minutes. Instead, the number of patients with significant improvement is provided per treatment arm.|||participants|||Number
2809192|NCT00457015|Secondary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100; best value]to significant worsening [-100; worst value]). Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose|Patients were excluded from this analysis if they did not have data for the endpoint being analyzed. The reasons for patients being excluded from this analysis are for ecallantide: 1 patient treated for severe upper airway compromise and for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data.|||units on a scale||Standard Deviation|Mean
2809193|NCT00457015|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose|Patients were excluded from the analysis if they did not have data for the endpoint being analyzed. Reasons for patients being excluded are for ecallantide: 1 patient treated for severe upper airway compromise; for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data. Best score=0.0; worst score=3.0.|||units on a scale||Standard Deviation|Mean
2809194|NCT00457002|Secondary|Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants|Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug and had available laboratory measurements.|||participants|||Number
2809195|NCT00457002|Secondary|Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements|Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.|Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)|Participants who received at least one dose of study drug, and had available laboratory results associated with the event and treatment group.|||participants|||Number
2809196|NCT00457002|Secondary|Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants|Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.|Day 1 to last dose of study drug plus 2 days|MI and thrombocytopenia categories: participants who received at least one dose of study drug. MI or stroke category: treated participants except those who did not have MI and had an inadequate assessment for stroke. Stroke category: treated participants except those with an inadequate assessment for stroke during the treatment period.|||Event Rate (%)||95% Confidence Interval|Number
2809197|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
2817684|NCT00399542|Secondary|Month 3 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF|||SBMs/week||Standard Deviation|Mean
2809198|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
2809199|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
2809200|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.|||participants|||Number
2809201|NCT00457002|Secondary|Mean Change From Baseline in Heart Rate in Treated Participants|Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.|||bpm||Standard Deviation|Mean
2809202|NCT00457002|Secondary|Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period|Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.|||mmHg||Standard Deviation|Mean
2809203|NCT00457002|Secondary|Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period|Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.|||mmHg||Standard Deviation|Mean
2809204|NCT00457002|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants|Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.|Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)|Participants who received at least one dose of study drug were analyzed (As Treated population).|||participants|||Number
2809205|NCT00457002|Secondary|Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period|A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
2809236|NCT00456885|Secondary|Changes in Body Composition|Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.|16 weeks after the beginning of each treatment||||per cent||95% Confidence Interval|Mean
2809206|NCT00457002|Primary|Incidence of All Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of drug to last dose of drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%)||95% Confidence Interval|Number
2809207|NCT00457002|Primary|Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%)||95% Confidence Interval|Number
2809208|NCT00457002|Primary|Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%):||95% Confidence Interval|Number
2809209|NCT00457002|Primary|Incidence of Major Bleeding During the Treatment Period in Treated Participants|Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.|||Event Rate (%)||95% Confidence Interval|Number
2809210|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment, were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809211|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period|Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment period, were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809220|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
2809212|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
2809213|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809214|NCT00457002|Secondary|Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809215|NCT00457002|Secondary|Incidence of Adjudicated PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809216|NCT00457002|Secondary|Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
2809217|NCT00457002|Secondary|Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809218|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.|||Event Rate (%)||95% Confidence Interval|Number
2809219|NCT00457002|Secondary|Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|All Randomized Participants.|||Event Rate (%)||95% Confidence Interval|Number
2809234|NCT00456885|Secondary|Diastolic Blood Pressure||16 weeks after the beginning of each treatment||||mm of mercury||95% Confidence Interval|Mean
2809235|NCT00456885|Secondary|Changes in Leptin||16 weeks from the start of each treatment period.||||ng/ml||95% Confidence Interval|Mean
2809262|NCT00456612|Primary|The Percent Progression -Free Survival at 6 Months Will be Tabulated||6 months|||||||
2809221|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
2809222|NCT00457002|Secondary|Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period|Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.|||Event Rate (%)||95% Confidence Interval|Number
2809223|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Secondary Efficacy Evaluable includes those who have an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event is not inadequate; or those with an adjudicated event that is part of the composite endpoint.|||Event Rate (%)||95% Confidence Interval|Number
2809224|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of parenteral treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had adjudicated and evaluable ultrasound at end of parenteral treatment, or had an adjudicated VTE-related death during the Parenteral Treatment Period.|||Event rate (%)||95% Confidence Interval|Number
2809225|NCT00457002|Primary|Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population|VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of intended treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had an adjudicated and evaluable ultrasound at end of intended treatment, or had an adjudicated total VTE-related death.|||Event rate (%)||95% Confidence Interval|Number
2809226|NCT00456989|Secondary|Response Rate|Data not analyzed, PI left institution|7 years|There is no data to report. Data for this trial was not analyzed, the PI left institution.||||||
2809227|NCT00456989|Primary|Maximum Tolerated Dose and Toxicity Profile||2 years|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2809228|NCT00456885|Secondary|REE|Resting Energy Expenditure|16 weeks from the start of each treatment period.||||Kilocalories||95% Confidence Interval|Mean
2809229|NCT00456885|Secondary|HOMA Score||16 weeks from the start of each treatment period.||||Ratio fasting glucose to insulin||95% Confidence Interval|Mean
2809230|NCT00456885|Secondary|Change in Two Hour Glucose||16 weeks from the start of each treatment period.||||mg/dl||95% Confidence Interval|Mean
2809231|NCT00456885|Secondary|Change in Fasting Glucose||16 weeks from the start of each treatment period.||||mg/dl||95% Confidence Interval|Mean
2809232|NCT00456885|Secondary|Change in Insulin||16 weeks from the start of each treatment period.||||microunits per liter||95% Confidence Interval|Mean
2809233|NCT00456885|Secondary|Adiponectin||16 weeks after the beginning of each treatment||||microgram per ml||95% Confidence Interval|Mean
2809237|NCT00456885|Secondary|Systolic Blood Pressure|Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.|16 weeks after the beginning of each treatment||||mm of mercury||95% Confidence Interval|Mean
2809238|NCT00456885|Secondary|Change in Waist Circumference||16 weeks from the start of each treatment period.||||centimeters||95% Confidence Interval|Mean
2809239|NCT00456885|Primary|Change in Body Mass Index||16 weeks from the start of each treatment period.||||Kg/m^2||95% Confidence Interval|Mean
2809240|NCT00456885|Primary|Change in Weight|Change in weight at the end of each treatment period.|16 weeks after the beginning of each treatment||||kilograms||Standard Error|Mean
2809241|NCT00456846|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 to Day 940|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||participants|||Number
2809242|NCT00456846|Secondary|Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Day 1 of study drug to Day 940; data cut off 31 May 2013|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||participants|||Number
2809243|NCT00456846|Secondary|Patient Survival|Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive.|Study start until death, or until data cut-off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.|||months||95% Confidence Interval|Median
2809244|NCT00456846|Secondary|Duration of Response Based on Investigator Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.|||months||95% Confidence Interval|Median
2809245|NCT00456846|Secondary|Duration of Response Based on Independent Reviewer Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population with a confirmed complete response or partial response.|||months||95% Confidence Interval|Median
2809246|NCT00456846|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2809247|NCT00456846|Secondary|Percentage of Participants With Disease Control|Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2809263|NCT00456599|Secondary|Overall Survival|Percent overall survival was calculated for all evaluable patients.|5 years|Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression).|||months||95% Confidence Interval|Median
2809264|NCT00456599|Secondary|Time to Treatment Failure|Median time for disease recurrence after surgery.|2 years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.|||months||Full Range|Median
2809248|NCT00456846|Primary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers|Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2809249|NCT00456807|Primary|Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples|Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, only on those subjects from the Cervarix group with CVS sample results available.|||correlation coefficient|||Number
2809250|NCT00456807|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies|Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. None of the subjects in the Placebo Group had detectable antibodies against HPV-16 at Months 12 and 18 and against HPV-18 at Month 12.|||Titer||95% Confidence Interval|Geometric Mean
2809251|NCT00456807|Primary|Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titers are presented as Geometric Mean Titers (GMTs).|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||Titer||95% Confidence Interval|Geometric Mean
2809252|NCT00456807|Primary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||Subjects|||Number
2809253|NCT00456807|Primary|Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18|"The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.~An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification."|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||cells per million B-cells||95% Confidence Interval|Geometric Mean
2809254|NCT00456807|Primary|Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines|The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.|||cells per million CD4/CD8 T-cells||95% Confidence Interval|Geometric Mean
2809255|NCT00456755|Secondary|Quality of Life (Difference Between Baseline and Week 4)|SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).|4 week|ITT|||Unit Score||Standard Deviation|Mean
2809256|NCT00456755|Primary|Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4|The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.|4 week||||Unit Score||Standard Deviation|Mean
2809257|NCT00456625|Secondary|Number of Participants Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to 1 month after the challenge dose.||||participants|||Number
2809258|NCT00456625|Secondary|Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~An AE is considered severe if it prevents normal, everyday activities."|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.||||participants|||Number
2809259|NCT00456625|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values|The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (including all evaluable subjects who had received the challenge dose of hepatitis B vaccine and for whom immunogenicity data were available at the post-hepatitis B vaccine challenge dose timepoint).|||participants|||Number
2809260|NCT00456612|Primary|Progression Free Survival||consent to prgression or death|||||||
2809261|NCT00456612|Secondary|Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.||1year|||||||
2809265|NCT00456599|Primary|Two-year Disease Free Survival.|The percent of patients alive and disease-free at two years.|two years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.|||percentage of patients||95% Confidence Interval|Number
2809266|NCT00456547|Secondary|Antithrombin III Levels at 2 Hours Post Delivery|Antithrombin III is a glycoprotein and is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII, the cofactor through which heparin exerts its effect. We hypothesized that women with continued bleed following delivery and require a hysterectomy will demonstrate a greater reduction in antithrombin III that women undergoing cesarean delivery.|2 hours after delivery||||percentage of normal antithrombin III||Standard Deviation|Mean
2809267|NCT00456547|Secondary|Plasminogen Levels 2 Hours After Delivery|Plasminogen is converted to plasmin when the coagulation system is activated. We hypothesized that plasminogen should be decrease more in women with continued bleeding following delivery requiring hysterectomy will demonstrated a greater decrease in plasminogen than following cesarean delivery.|2 hours after delivery||||mg/dL||Standard Deviation|Mean
2809268|NCT00456547|Secondary|Platelet Counts at 2 Hours After Delivery|Platelets are decreased in subjects with consumptive coagulopathies which is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases. We hypothesized that women who require hysterectomy for postpartum bleeding are more likely to have decreased platelet counts than matched controls that underwent cesarean delivery.|2 hours after delivery||||platelets (*1000 per liter)||Standard Deviation|Mean
2809269|NCT00456547|Primary|Fibrinogen Level at 2 Hours After Delivery|Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.|2 hours after delivery||||mg/dL||Standard Deviation|Mean
2809270|NCT00456521|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2809271|NCT00456521|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2809272|NCT00456521|Secondary|Change in Food Craving Inventory Sweets Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2809273|NCT00456521|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2809274|NCT00456521|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mmHg||Standard Error|Least Squares Mean
2809275|NCT00456521|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mmHg||Standard Error|Least Squares Mean
2809276|NCT00456521|Secondary|Change in Fasting LDL Cholesterol||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2809277|NCT00456521|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2809278|NCT00456521|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2809294|NCT00456365|Secondary|Left Ventricular Mass Index|left ventricular mass index in g/m^2 by MRI|3 years||||g/m^2||Standard Deviation|Mean
2809279|NCT00456521|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2809280|NCT00456521|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2809281|NCT00456521|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2809282|NCT00456521|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2809283|NCT00456521|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percent change||95% Confidence Interval|Least Squares Mean
2809284|NCT00456521|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||cm||Standard Error|Least Squares Mean
2809285|NCT00456521|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2809286|NCT00456521|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of participants||95% Confidence Interval|Number
2809287|NCT00456521|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.|||percentage of body weight||Standard Error|Least Squares Mean
2809288|NCT00456508|Secondary|Time to Significant Improvement|"Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of a lot better or resolved in the overall response assessment."|15 min - 4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.|||estimated time in minutes||95% Confidence Interval|Median
2809289|NCT00456508|Secondary|Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms|The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.|||scores on a scale||Standard Deviation|Mean
2809290|NCT00456508|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing|Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in MSCS score.|||scores on a scale||Standard Deviation|Mean
2809291|NCT00456495|Secondary|Evaluating Tumor Destruction or Reduction|To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.|2 years||||Participants|||Count of Participants
2809292|NCT00456495|Primary|Number of Patients Assessed for Safety and Tolerability|To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).|2 years|Analysis was per protocol. Treatment was delivered every 2-4 weeks with good safety and tolerability|||participants|||Number
2809293|NCT00456365|Secondary|Urinary Albumin Excretion||3 years||||mcg/min||Standard Deviation|Mean
2809296|NCT00456365|Primary|Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume|Percent of participants demonstrating 20% or more increase in total kidney volume corrected for height, left ventricular mass index, or urinary albumin excretion over the three year study period|3 years|Intention to treat|||percentage of participants|||Number
2809297|NCT00456300|Primary|Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone|Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection|0-120 minutes post-dose|All participants who received at least one dose of each intervention and completed all study visits were included in the analyses. Only 8 subjects completed all study visits and one dropped out during the second study visit.|||mmol*L/min||Standard Error|Mean
2809298|NCT00456261|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Number
2809299|NCT00456261|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months||||percentage of patients||95% Confidence Interval|Number
2809300|NCT00456261|Primary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the date of treatment initiation and the date of progressive disease|18 months||||months||95% Confidence Interval|Median
2809301|NCT00456092|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24|"The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The total score ranges from 0 to 52 with higher scores representing less fatigue."|Baseline (Day 1), Week 12 (Day 85) and Week 24|Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809302|NCT00456092|Secondary|Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24|The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).|Baseline (Day 1), Week 12 (Day 85) and Week 24|Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809303|NCT00456092|Secondary|Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24|The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.|Baseline (Day 1), Week 12 (Day 85) and Week 24|Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809304|NCT00456092|Secondary|Change From Baseline and Week 12 in SF-36 at Week 24|The Medical Outcome SF 36-Item Health Survey, Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.|Baseline (Day 1), Week 12 (Day 85) and Week 24|Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809305|NCT00456092|Secondary|Number of Participants Who Relapsed After the Extension Phase|Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase/Early Termination Visit.|Week 24 to Week 28 (28-day follow-up period)|Participants with an ACR 20 response at the Week 24 (or Early Termination) visit and entered the Follow-up Phase after the Extension Phase|||participants|||Number
2809306|NCT00456092|Secondary|Time to Relapse of Psoriatic Arthritis After Extension Phase|Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase (Week 24)/Early Termination Visit. The time to relapse during the Follow-up Phase was calculated from the time of maximum ACR reduction and from the date of the Final Extension Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.|From Week 24 to the end of the 28-day follow-up (1) and from the date of maximal ACR until the end of the 28-day follow-up phase (2).|Participants with an ACR 20 response at the Week 24 (or Early Termination) visit and entered the Follow-up Phase after the Extension Phase|||days||95% Confidence Interval|Median
2809687|NCT00454142|Secondary|Pharmacokinetic Study: Area Under Curve (AUC) 0-24h/Dose on Day 28|AUC 0-24h/dose were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment||||hr*ng/mL/mg||Full Range|Median
2809307|NCT00456092|Secondary|Percentage of Participants With Enthesitis in the Extension Phase|Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.|Week 12 and Week 24|Participants enrolled in the Extension Phase|||percentage of participants|||Number
2809308|NCT00456092|Secondary|Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60. Change in the dactylitis severity score was assessed from Baseline (Day 1) and from Week 12 (Day 85).|Baseline, Week 12 and Week 24|Participants enrolled in the Extension Phase with a baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809309|NCT00456092|Secondary|Time to ACR 70 Response During the Treatment and Extension Phase|Time to ACR 70 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 70 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 70 response were calculated for participants who had an ACR 70 response at any time during the study.|Baseline to Week 24|Participants enrolled in the Extension Phase with an ACR 70 response at any time during the study|||days||95% Confidence Interval|Median
2809310|NCT00456092|Secondary|Time to ACR 50 Response During the Treatment and Extension Phase|Time to ACR 50 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 50 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 50 response were calculated for participants who had an ACR 50 response at any time during the study.|Baseline to Week 24|Participants enrolled in the Extension Phase with an ACR 50 response at any time during the study|||days||95% Confidence Interval|Median
2809311|NCT00456092|Secondary|Time to ACR 20 Response During the Study|Time to ACR 20 was measured from the first dose of apremilast to the first time a participant achieved an ACR 20 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 20 response were calculated for participants who had an ACR 20 response at any time during the study.|Baseline to Week 24|Participants enrolled in the Extension Phase with an ACR 20 response at any time during the study|||days||95% Confidence Interval|Median
2809312|NCT00456092|Secondary|Maximal ACR Response During the Extension Period|The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: • percent improvement from Baseline in the 76 swollen joint count, • percent improvement from Baseline in the 78 tender joint count • median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week extension period was calculated, and represents the maximal ACR response achieved.|ACR was measured at Baseline and Weeks 16, 20 and 24|Participants enrolled in the Extension Phase with non-missing ACR data|||percent improvement||Standard Deviation|Mean
2809313|NCT00456092|Secondary|Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24|The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2|Baseline and Week 24|Participants enrolled in the Extension Phase; LOCF imputation was used.|||percentage of participants|||Number
2809314|NCT00456092|Secondary|Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24|The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein • Patient's global assessment of disease activity according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2|Baseline and Week 24|Participants enrolled in the Extension Phase; LOCF imputation was used.|||percentage of participants|||Number
2809322|NCT00456092|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12|The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.|Baseline and Week 12|Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2817685|NCT00399542|Secondary|Month 2 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF|||SBMs/week||Standard Deviation|Mean
2809315|NCT00456092|Secondary|Percentage of Participants With a Modified ACR 70 Response at Week 24|A modified ACR 70 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1). Participants with no post-baseline ACR scores were considered non-responders.|Baseline (Day 1) and Week 24|Participants enrolled in the Extension Phase; LOCF imputation was used.|||percentage of participants|||Number
2809316|NCT00456092|Secondary|Percentage of Participants With a Modified ACR 50 Response at Week 24|A modified ACR 50 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.|Baseline (Day 1), Week 12 (Day 85) and Week 24|Participants enrolled in the Extension Phase; LOCF imputation was used. For the analysis of response from Week 12 (Day 85), participants with a tender or swollen joint count of 0 at Day 85 were excluded.|||percentage of participants|||Number
2809317|NCT00456092|Secondary|Percentage of Participants With a Modified ACR 20 Response at Week 24|A modified ACR 20 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.|Baseline (Day 1), Week 12 (Day 85) and Week 24|Participants enrolled in the Extension Phase; LOCF imputation was used. For the analysis of response from Week 12 (Day 85), participants with a tender or swollen joint count of 0 at Day 85 were excluded.|||percentage of participants|||Number
2809318|NCT00456092|Secondary|Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.|Baseline and Week 24|Participants enrolled in the Extension Phase; LOCF imputation was used.|||percentage of participants|||Number
2809319|NCT00456092|Secondary|Number of Participants With Adverse Events During the Extension Phase|The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.|Weeks 12 to 24 (Extension Phase)|The safety population; participants who entered the Extension Phase.|||Participants|||Count of Participants
2809320|NCT00456092|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12|"The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The total score ranges from 0 to 52 with higher scores representing less fatigue."|Baseline and Week 12|Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809321|NCT00456092|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).|Baseline and Week 12|Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809323|NCT00456092|Secondary|Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12|The Medical Outcome SF 36-Item Health Survey, Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.|Baseline and Week 12|Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809324|NCT00456092|Secondary|Number of Participants Who Relapsed During the Observational Follow-up Phase|Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit.|28-day observational follow-up period following Week 12|Participants who received apremilast with an ACR 20 response at the Week 12 (or Early Termination) visit who did not enroll in the Extension Phase.|||Participants|||Count of Participants
2809325|NCT00456092|Secondary|Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase|Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit. The time to relapse during the Observational Phase was calculated from the time of maximum ACR reduction and from the date of the Final Treatment Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.|From Week 12 to end of 28-day observational follow-up (1) and from the date of maximal ACR during the 12-week Treatment Phase until the end of the 28-day observational follow-up phase (2).|Participants who received apremilast and with an ACR 20 response at the Week 12 (or Early Termination) visit who did not enroll in the Extension Phase.|||days||95% Confidence Interval|Median
2809326|NCT00456092|Secondary|Percentage of Participants With Enthesitis|Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.|Baseline and Week 12|Intent-to-treat population|||percentage of participants|||Number
2809327|NCT00456092|Secondary|Change From Baseline in Dactylitis Severity Score at Week 12|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60.|Baseline and Week 12|Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2809328|NCT00456092|Secondary|Time to ACR 70 Response During the Treatment Phase|The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.|Baseline to Week 12|Intent-to-treat population with an ACR 70 response during the treatment phase.|||days||95% Confidence Interval|Median
2809329|NCT00456092|Secondary|Time to ACR 50 Response During the Treatment Phase|The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.|Baseline to Week 12|Intent-to-treat population who had an ACR 50 response during the treatment phase.|||days||95% Confidence Interval|Median
2809330|NCT00456092|Secondary|Time to ACR 20 Response During the Treatment Phase|The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.|Baseline to Week 12|Intent-to-treat population with an ACR 20 response during the treatment phase.|||days||95% Confidence Interval|Median
2809331|NCT00456092|Secondary|Maximal ACR Response During the Treatment Phase|The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: - percent improvement from Baseline in the 76 swollen joint count, - percent improvement from Baseline in the 78 tender joint count - median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week treatment period was calculated, and represents the maximal ACR response achieved.|ACR was measured at Baseline and Weeks 2, 4, 6, 8, 10, and 12|Intent-to-treat population with non-missing ACR data|||percent improvement||Standard Deviation|Mean
2809332|NCT00456092|Secondary|Number of Participants With Adverse Events Leading to a Dose Reduction|The number of participants who were dose reduced during the treatment phase due to adverse events.|Baseline to Week 12|Safety population|||Participants|||Count of Participants
2809333|NCT00456092|Secondary|Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy|The number of participants who withdrew prematurely from the treatment phase due to lack of efficacy, including flare of psoriasis, flare of psoriatic arthritis or worsening or not responding to study treatment.|Baseline to Week 12|Intent-to-treat population|||Participants|||Count of Participants
2809429|NCT00455312|Secondary|Overall Survival|Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive.|1 Year||||Participants|||Count of Participants
2809430|NCT00455312|Secondary|Overall Survival|Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive.|Day 100||||Participants|||Count of Participants
2809334|NCT00456092|Secondary|Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12|The DAS28-CRP(3) measures the severity of disease derived from the following 3 variables: • 28 tender joint count (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) DAS28-CRP(3) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(3) score of ≤ 3.2. In remission is defined as a DAS28-CRP(3) score of ≤ 2.6.|Week 12|Intent-to-treat population; LOCF imputation was used. Participants with no post-baseline DAS28-CRP(3) scores were considered non-responders.|||percentage of participants|||Number
2809335|NCT00456092|Secondary|Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12|The DAS28-CRP(4) measures the severity of disease derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28-CRP(4) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(4) score of ≤ 3.2. In remission is defined as a DAS28-CRP(4) score of ≤ 2.6.|Week 12|Intent-to-treat population; LOCF imputation was used. Participants with no post-baseline DAS28-CRP(4) scores were considered non-responders.|||percentage of participants|||Number
2809336|NCT00456092|Secondary|Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12|The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2|Baseline and Week 12|Intent-to-treat population; LOCF imputation was used. Participants with no baseline or post-baseline DAS28-CRP(3) scores were considered non-responders.|||percentage of participants|||Number
2809337|NCT00456092|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12|The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (TJC; does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count (SJC) • C-reactive protein (CRP) • Patient's global assessment of disease activity (GH) according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2|Baseline and Week 12|Intent-to-treat population; LOCF imputation was used. Participants with no baseline or post-baseline DAS28-CRP(4) scores were considered non-responders.|||percentage of participants|||Number
2809338|NCT00456092|Secondary|Percentage of Participants With a Modified ACR 70 Response at Week 12|A modified American College of Rheumatology 70% (ACR 70) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.|Baseline and Week 12|Intent-to-treat population; LOCF imputation was used.|||percentage of participants|||Number
2809339|NCT00456092|Secondary|Percentage of Participants With a Modified ACR 50 Response at Week 12|A modified American College of Rheumatology 50% (ACR 50) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.|Baseline and Week 12|Intent-to-treat population; LOCF imputation was used.|||percentage of participants|||Number
2809340|NCT00456092|Secondary|Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12|A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures, according to the following: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with no post-baseline PsARC scores were considered non-responders.|Baseline and Week 12|Intent-to-treat population; LOCF imputation was used.|||percentage of participants|||Number
2817686|NCT00399542|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809341|NCT00456092|Secondary|Number of Participants With Adverse Events During the Treatment Phase|The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.|12 weeks|The safety population which consisted of all enrolled participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2809342|NCT00456092|Primary|Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12|A modified American College of Rheumatology 20% (ACR 20) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.|Baseline and Week 12|The intent-to-treat (ITT) population which consisted of all randomized participants with at least one of the ACR components assessed at baseline. Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
2809343|NCT00456014|Secondary|Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase|Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis.|Measured at Week 8|Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. 25 of the 28 SSRI participants completed a trial of escitalopram. 3 of 28 SSRI participants had intolerable side-effects to escitalopram, and were therefore switched to sertraline, and completed a trial of sertraline instead.|||% improvement in depression symptoms||Standard Deviation|Mean
2809344|NCT00456014|Secondary|Remission of Depressive Symptoms - Tricyclic Phase|Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status.|Measured over 8 weeks|Depressed participants who did not remit during the SSRI phase advanced to the tricyclic phase of the study. Five participants started treatment with desipramine, one of which also had a trial with nortriptyline. Two participants started tricyclic treatment with nortriptyline.|||participants|||Number
2809345|NCT00456014|Primary|Remission of Depressive Symptoms|Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score <10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.|Measured at Week 8|"28 of 38 participants completed the SSRI phase. Only those 28 participants were assessed for remission status.~1 participant who is counted as a non-remitter had a spontaneous remission following his MRI."|||participants|||Number
2809346|NCT00455975|Secondary|Overall Tolerability and Toxicity of High-dose Bevacizumab|Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities|18 months|All patients treated with Bevacizumab therapy were assessed for Grade 3/4 toxicities|||participants|||Number
2809347|NCT00455975|Secondary|Objective Response Rate|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|18 months||||participants|||Number
2809348|NCT00455975|Secondary|Overall Survival (OS)|Measured from date of study entry to date of death due to any cause.|18 months||||months||95% Confidence Interval|Median
2809349|NCT00455975|Primary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months (expected)||||months||95% Confidence Interval|Median
2809350|NCT00455962|Primary|LH Peak in Response to Estrogen Positive Feedback|Estradiol levels are consistently higher in African-American vs Caucasian women across the menstrual cycle. This study was designed to determine if African-American women are more sensitive to estrogen positive feedback to generate the preovulatory LH surge using a controlled estrogen infusion paradigm.|5 days of estradiol and progesterone infusion|Healthy African-American and Caucasian women aged 18-35 with regular ovulatory menstrual cycles.|||IU/L||Standard Error|Mean
2809351|NCT00455923|Secondary|Time to Increase of Study Medication|Data for this outcome measure was not collected.|Up to 6 months|ITT population. Data for this outcome measure was not collected.||||||
2809431|NCT00455312|Secondary|Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100||||Participants|||Count of Participants
2809432|NCT00455312|Secondary|Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100||||Participants|||Count of Participants
2809352|NCT00455923|Secondary|Number of Exacerbations: in Total and by Degree of Severity|Severe exacerbation: needed hospitalization/emergency unit visit. Moderate exacerbation: Needed oral cortico-steroid or adding inhaled Flixotide to maintenance study medicine; decrease in morning or evening peak expiratory flow (PEF) > 30% during ≥ 2 following days from Baseline (Day 0). Mild exacerbation: any night symptoms ≥ 3 consecutive, or night symptoms ≥ 2 consecutive nights in case symptoms have been scored ≥ 2 during at least one night, Day symptoms scored ≥ 2 during ≥ 4 following days, or Day symptoms scored ≥ 3 during ≥ 3 following days, or Day symptoms scored ≥ 4 during ≥ 2 following days, or rescue medication use ≥ 2 occasions per day for ≥ 4 following days, or rescue medication use ≥ 3 occasions per day for ≥ 3 following days, or rescue medication use ≥ 4 occasions per day for ≥ 2 following days, or decrease in morning/evening PEF >20% during ≥ 2 following days from Baseline (Day 0). Number of total exacerbations and severe, moderate and mild exacerbations are presented.|Up to 18 months|ITT Population.|||Exacerbations|||Number
2809353|NCT00455923|Secondary|Number of Symptom-free Days and Nights Without Use of Rescue Medication|The rescue medications used for exacerbations included Ventoline Diskus® 200 mcg/dose inhalations as required and oral Prednisolone 25 mg per day for five days, and when necessary, ten days. Data for this outcome measure was not collected.|Up to 18 months|ITT population. Data for this outcome measure was not collected.||||||
2809354|NCT00455923|Secondary|Change in Bronchial Hyper-responsiveness From Baseline to 18 Months|Data for this outcome measure was not collected.|Baseline (Day 0) to 18 months|ITT population. Data for this outcome measure was not collected.||||||
2809355|NCT00455923|Secondary|Absolute Bronchial Hyper-responsiveness up to 18 Months|Data for this outcome measure was not collected.|Up to 18 months|Data for this outcome measure was not collected.||||||
2809356|NCT00455923|Primary|Number of Participants in Each Arm With a Need for an Increase in Study Medication|During the first 6 months, when the asthma was unstable/uncontrolled, dose of Seretide (Sal/FP) was increased from 50/100 mcg in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). Also, dose of Flixotide (FP only), was increased from 100 mcg to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months. Number of participants in each arm with a need for an increase in study medication are presented.|Up to 18 months|Intent-to-Treat (ITT) Population which comprised of all participants who were randomized and received at least one dose of the study medication.|||Participants|||Count of Participants
2809357|NCT00455858|Secondary|Occurence of Hypoglycaemic Episodes|Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.|weeks 0-20|For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.|||episodes|||Number
2809358|NCT00455858|Secondary|Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%|Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%|week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||percentage of participants|||Number
2809359|NCT00455858|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20|week 0, week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||mg/dL||Standard Deviation|Mean
2809360|NCT00455858|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12|Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline|week 0, week 12|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||percentage change in HbA1c||Standard Deviation|Mean
2809361|NCT00455858|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20|week 0, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.|||percentage change in HbA1c||Standard Deviation|Mean
2809362|NCT00455741|Secondary|18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Positive Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|24 vs 72 hr|postmenopausal women|||unit||Standard Error|Mean
2809363|NCT00455741|Secondary|18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Positive Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|24 hr vs 72 hr|postmenopausal women|||units||Standard Error|Mean
2809364|NCT00455741|Secondary|18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Negative Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|0 vs 24 hr|postmenopausal women|||units||Standard Error|Mean
2809365|NCT00455741|Secondary|18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Negative Feedback|Regional cerebral glucose metabolism (rCMRglu) is used as a measure of neuronal metabolic activity and calculated as average uptake (voxels) of 18 flurodeoxyglucose within the region of interest (ROI) and expressed simply as units. Normalized uptake refers to co-registration of the PET with the MRI to provide more accurate anatomic correlates.|Baseline vs 24 hr after the onset of steroid infusion|postmenopausal women|||units||Standard Error|Mean
2809433|NCT00455312|Secondary|Incidence of Late Secondary Malignancies|Defined as patients who have a secondary malignancy (cancer) occurring.|1 Year||||Participants|||Count of Participants
2809366|NCT00455741|Primary|Effect of Aging on Estrogen Positive Feedback on LH|LH area under the curve in response to estrogen positive feedback. Area under the curve was calculated from blood samples drawn every 4 hours from the onset of positive feedback until the end of the study (120 min). The onset of positive feedback is defined as the time when LH first exceeds mean + 2SD of the previous three time points and shows a sustained rise.|Onset of surge (average of 61 hr from beginnning of infusion until the end of the study (120 hr)|NOTE: 2 older and 2 younger postmenopausal women excluded from this analysis as estradiol levels exceeded physiological exposure levels|||IU*hr/L||Standard Error|Mean
2809367|NCT00455741|Primary|Effect of Aging on Estrogen Negative Feedback on LH|Difference between baseline LH (average of 3 samples drawn 15 min apart) and nadir LH based on a 3-point moving average of blood samples drawn every 4 hours over 120 hr, expressed as a percent of baseline (% baseline).|Baseline at 0 time before infusion, nadir occurred between 8 and 60 hr (mean 24 hr)|NOTE: 2 older and 2 younger postmenopausal women excluded from this analysis as estradiol levels exceeded physiological exposure levels|||% change from baseline||Standard Error|Mean
2809368|NCT00455702|Secondary|Treatment Effects on the Positive Syndrome Subscale of the PANSS|The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8 score|One participant from the placebo group was removed from this analysis.|||PANSS Positive Subscale Units||Standard Deviation|Mean
2809369|NCT00455702|Primary|Main Outcome Measure: The Change From Baseline to Week 8 on the SANS|The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8||||Units on a scale||Standard Deviation|Mean
2809370|NCT00455689|Secondary|Change in Subjective Sleep Quality|Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention.|baseline (before receiving intervention) and 4 weeks after receiving intervention||||units on a scale||Inter-Quartile Range|Median
2809371|NCT00455689|Primary|Percent Change in Objective Sleep Efficiency|Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.|baseline (before receiving intervention) and 4 weeks after receiving intervention||||percent change||Inter-Quartile Range|Median
2809372|NCT00455663|Primary|Number of Patients Surviving Without Relapse/Exacerbation|A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision|9 months of treatment 6 months follow up|Number of participants meeting bprs criteria for at least partial remission.scores on 3 of the 4 BPRS psychosis items had to be 4 or lower indicating moderate symptoms only.|||participants|||Number
2809373|NCT00455663|Primary|Social and Occupational Functioning Scale Score|Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 endpoint ls means combining 9 months of treatment and 6 months follow up||||units on a scale||Standard Error|Mean
2809374|NCT00455663|Primary|Positive Symptoms|Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up||||units on a scale||Standard Error|Least Squares Mean
2809375|NCT00455663|Primary|Medication Adherence-pill Count|% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final score combined for endpoint for 9 months of treatment and 6 months follow up||||percentage of medication taken||Standard Error|Least Squares Mean
2809376|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task|In the Visual spatial working memory (VSWM), participants were asked to place the cursor where the symbol appeared immediately after its display. For 16 additional trials, participants were asked to identify the symbol location after a 30-second delay. During the delay, participants were distracted by being asked to read aloud words appearing on the screen at 2-second intervals. The outcome of interest in this task were the average distance from the target for immediate and delayed recall There is only one outcome measure time frame because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point||||Distance (in)||Standard Deviation|Mean
2809434|NCT00455312|Secondary|Incidence of Chronic GVHD|Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.|1 year||||Participants|||Count of Participants
2809377|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task|"The N-back task with 1- and 2-back parametric conditions was used. During the task, a letter was displayed for 1,500 ms every 2 s with a 500 ms isi. Participants were asked to press the 1 key for letters that corresponded to the letter 1 back for the 1-back condition, the 2 key for the 2-back condition, and the 3 key for nontarget letters. Outcome variable presented is hit reaction time There is only one outcome measure time point because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors."|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point||||ms||Standard Deviation|Mean
2809378|NCT00455650|Secondary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task|"In the 3-card Stroop Task, 3 cards were presented; the 1st contained color names printed in black ink, the 2nd contained colored patches of ink, the 3rd contained color names printed in incongruously colored ink. Participants were asked to read or name as many items as possible in 45 seconds for each condition. Individuals are asked to identify the color of the ink of a word. They may be distracted by the presence of a word that states another color (i.e. the word blue written in green ink would require the answer green).The interference score was calculated by dividing the color-word score by the color score. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs varenicline vs pbo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor as well as study period and drug administration sequence as between subject crossover design factors"|Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point||||score||Standard Deviation|Mean
2809379|NCT00455650|Primary|Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability|The Continuous Performance Test-Identical Pairs, CPT-IP, Version 4.0 was developed and normed for use in people with schizophrenia and normal controls. This task estimates attention by requiring an individual to push a response key when two identical pairs of shapes or numbers are presented in sequence. Stimuli were presented with increasing cognitive load: 2-, 3-, and 4-digit targets. Outcome variables measured included correct hits, hit reaction time (HRT), errors of commission: false alarms and random errors, and the primary outcome, variability, or standard deviation, of hit reaction time, HRT-SD. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors.|Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description)||||ms||Standard Deviation|Mean
2809380|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups|For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.||||||
2809381|NCT00455533|Secondary|Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel|||participants|||Number
2809382|NCT00455533|Secondary|Number of Participants With Course Delay and Reason for Delay for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC|||participants|||Number
2809383|NCT00455533|Secondary|Reason for First Dose Reduction of Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel|||participants|||Number
2809384|NCT00455533|Secondary|Reason for First Dose Reduction of AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC|||participants|||Number
2809385|NCT00455533|Secondary|Number of Participants by Dose for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants|||participants|||Number
2809386|NCT00455533|Secondary|Number of Participants by Dose for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants|||participants|||Number
2809387|NCT00455533|Secondary|On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.|||Participants|||Number
2809435|NCT00455312|Secondary|Incidence of Chronic GVHD|Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.|6 months||||Participants|||Count of Participants
2809388|NCT00455533|Secondary|On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.|||Participants|||Number
2809389|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations|Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%).|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size [N] not applicable).|||Percentage of Participants||90% Confidence Interval|Number
2809390|NCT00455533|Secondary|On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.|||Participants|||Number
2809391|NCT00455533|Secondary|Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class|MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy|Ixabepilone- and Paclitaxel-treated participants|||Participants|||Number
2809392|NCT00455533|Secondary|Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy||||Participants|||Number
2809393|NCT00455533|Secondary|Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)|Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment|Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.|||Percentage of Participants||90% Confidence Interval|Number
2809394|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants|Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized estrogen negative participants with non-missing pCR and biomarker expression|||percentage of participants||90% Confidence Interval|Number
2809395|NCT00455533|Secondary|Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds|Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR/RCB1 and biomarker expression|||percentage of participants||90% Confidence Interval|Number
2809396|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds|Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR and biomarker expression|||percentage of participants||90% Confidence Interval|Number
2809397|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1~Biomarker:Treatment: ER) & reduced model (pCR/RCB1~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) & reduced model (pCR/RCB1~Biomarker+Treatment); 3) contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model (pCR/RCB1~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.||||participants|||Number
2809398|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR~Biomarker:Treatment:estrogen receptor [ER]) & reduced model (PCR~Treatment:ER); 2) the likelihood ratio test between the full model (PCR~Biomarker:Treatment) & reduced model (PCR~Biomarker+Treatment); 3) the contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model(PCR~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.||||participants|||Number
2809399|NCT00455533|Secondary|Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1|Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
2809400|NCT00455533|Secondary|Percentage of Participants Requiring Breast Conservation Surgery|Number of randomized participants requiring breast conservation surgery following study treatment.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
2809401|NCT00455533|Secondary|Percentage of Participants Achieving Clinical Objective Response|Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.|after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
2809402|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR)|The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants|||Percentage of Participants||90% Confidence Interval|Number
2809403|NCT00455520|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||Scores on a scale||Standard Deviation|Mean
2809404|NCT00455520|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time (hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||Hours||Standard Deviation|Mean
2809405|NCT00455520|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|12 week endpoint (change from baseline)|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||scores on a scale||Standard Deviation|Mean
2809436|NCT00455312|Secondary|Incidence of Regimen Related Mortality at 100 Days|all deaths without previous relapse or progression|100 days||||Participants|||Count of Participants
2809406|NCT00455520|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Percentage of patients who reported very much improved (1) or much improved (2) based on an ordinal measure indicating change from start of double blind treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||percentage of patients|||Number
2809407|NCT00455520|Secondary|The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.|The number of patients achieving at least 30% improvement in pain score at Week 12 of the double-blind maintenance period on an 11-point numerical rating scale compared with the start of the open-label period.|Start of Open Label and at 12 weeks of Double Blind|Intent-to-treat analysis set.|||participants|||Number
2809408|NCT00455520|Primary|Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.|||scores on a scale||Standard Deviation|Mean
2809409|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
2809410|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
2809411|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|day 7|intent to treat analysis including only participants who had completed the study|||units on a scale||Standard Deviation|Mean
2809412|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
2809413|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|baseline|intent to treat analysis including only participants who had completed the study|||units on a scale||Standard Deviation|Mean
2809414|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study|||percent CO2||Standard Deviation|Mean
2809415|NCT00455429|Secondary|Plasma Concentration of JNJ-26113100|Blood samples for pharmacokinetic (PK) analysis were collected before dosing and at 0.25 to 3 hours after dosing at randomization (Day 1) and Week 3 visit and at 0.25 to 3 hours, 4 to 6 hours, and 7 to 12 hours after dosing at Week 6.|Before dosing on Day 1, Week 3, Week 6; after dosing at 0.25 to 3 hours on Day 1, Week 3, Week 6; after dosing at 4 to 6 hours and 7 to 12 hours on Week 6|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to treatment groups and received at least 1 dose of study drug. LOCF method was used.|||nanogram (ng)/milli litre (mL)||Standard Deviation|Mean
2809416|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Worsening AD Event|Percentage of Participants who had at least 1 Worsening AD Event That did not Meet Flare Criteria were assessed. Worsening of AD that did not meet flare criteria was documented. Flare was considered to be present if either of the following criteria were met: 1) IGA was=2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809417|NCT00455429|Primary|Number of Flare Occurrences Per Participant|A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0 or 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||participants|||Number
2809418|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Flare|Percentage of participants who had at Least 1 Flare while on treatment was assessed. A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809419|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6|"VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=No itch on the left side of the line and the words 10 cm=Worst possible itch on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between No itch and Worst possible itch which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure."|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809420|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6|"VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=No itch on the left side of the line and the words 10 cm=Worst possible itch on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between No itch and Worst possible itch which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure."|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809421|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6|"VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=No itch on the left side of the line and the words 10 cm=Worst Possible Itch on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between No itch and Worst possible itch which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure."|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809422|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=25% from the baseline EASI score. An improvement of <25% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809423|NCT00455429|Primary|Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=50% from the baseline EASI score. An improvement of <50% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809424|NCT00455429|Primary|"Percentage of Participants Achieving Treatment Response as Clear or Almost Clear in IGA"|Percentage of participants achieving treatment response (decrease) in IGA were assessed. IGA is used to assess AD through a 6-point scale (Range=0-5) where, 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema & perceptible papulation/infiltration), 2=mild (mild erythema & papulation/infiltration), 3=moderate (moderate erythema & papulation/infiltration), 4=severe (severe erythema & papulation/infiltration) & 5=very severe (severe erythema & papulation/infiltration with oozing/crusting). Success is reduction of IGA to 0 or 1. Failure is reduction of IGA to >=2.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||percentage of participants|||Number
2809425|NCT00455429|Primary|Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6|"VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=No itch on the left side of the line and the words 10 cm=Worst possible itch on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between No itch and Worst possible itch which best describes their itching during the preceding 24 hours."|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||millimeter (mm)||Standard Deviation|Mean
2809426|NCT00455429|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2809427|NCT00455429|Primary|Investigator's Global Assessment (IGA) Score at Week 6|Participants were reported for IGA. IGA is an overall assessment of Atopic Dermatitis (AD). IGA utilizes a 6-point scale (ranging from 0 to 5): 0=clear (noinflammatory signs of AD), 1=almost clear (just perceptible erythema, and just perceptible papulation/infiltration), 2=mild disease (mild erythema, and mild papulation/infiltration), 3=moderate disease (moderate erythema, and moderate papulation/infiltration), 4=severe disease (severe erythema, and severe papulation/infiltration) and 5=very severe disease (severe erythema, and severe papulation/infiltration with oozing/crusting).|Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. Last Observation Carried Forward (LOCF) method was used.|||participants|||Number
2809428|NCT00455312|Secondary|Incidence of Pulmonary Complications|Defined as patients who exhibit a pulmonary (lung) adverse event.|6 Months||||Participants|||Count of Participants
2809437|NCT00455312|Primary|Neutrophil Engraftment|Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation.|Day 100||||Participants|||Count of Participants
2809438|NCT00455195|Secondary|Change From Baseline in Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and is standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Change is calculated as the value minus the baseline value. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0 , Week 104|Intent-to-treat population of participants who had valid baseline (Week 0) and Week 104 data.|||units on a scale||Standard Deviation|Mean
2809439|NCT00455195|Secondary|Baseline Values (Week 0) for Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and are standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population of participants with valid baseline (Week 0) PCS surveys.|||units on a scale||Standard Deviation|Mean
2809440|NCT00455195|Primary|Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.|||percent of predicted FVC||Standard Deviation|Mean
2809441|NCT00455195|Primary|Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population|||percent of predicted FVC||Standard Deviation|Mean
2809442|NCT00455195|Secondary|Change From Baseline (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.|||percent of predicted QMT||Standard Deviation|Mean
2809443|NCT00455195|Primary|Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.|||meters||Standard Deviation|Mean
2809444|NCT00455195|Primary|Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population.|||meters||Standard Deviation|Mean
2809445|NCT00455195|Secondary|Baseline Values (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0|Intent-to-treat population|||percent of predicted QMT||Standard Deviation|Mean
2809600|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809446|NCT00455195|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|"The numbers of participants who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment with alglucosidase alfa.~Participants with long-term exposure to alglucosidase alfa (those from the Alglucosidase Alfa/Alglucosidase Alfa treatment group) are included. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600)."|Week 0 to 2.5 years|The safety population includes all participants randomized to alglucosidase alfa treatment in AGLU02704 (NCT00158600) who received at least one infusion of alglucosidase alfa.|||participants|||Number
2809447|NCT00455143|Secondary|Delirium Assessments||6 months post surgery|Main protocol became funded, study terminated, data not collected.||||||
2809448|NCT00455143|Secondary|Delirium Assessments||3 months post surgery|Main protocol became funded, study terminated, data not collected.||||||
2809449|NCT00455143|Secondary|Delirium Assessments||duration of PACU stay, up to 4 days post-op|Main protocol became funded, study terminated, data not collected.||||||
2809450|NCT00455143|Secondary|Delirium Assessments||prior to surgery|Main protocol became funded, study terminated, data not collected.||||||
2809451|NCT00455143|Secondary|Cognitive Testing||6 months post surgery|Main protocol became funded, study terminated, data not collected.||||||
2809452|NCT00455143|Secondary|Cognitive Testing||3 months post surgery|Main protocol became funded, study terminated, data not collected.||||||
2809453|NCT00455143|Secondary|Cognitive Testing||prior to surgery|This study terminated because main study became funded, data not collected.||||||
2809454|NCT00455143|Primary|Functional Recovery||6 months post surgery|This study terminated because main study became funded, data not collected.||||||
2809455|NCT00455143|Primary|Functional Recovery||3 months post surgery|Main protocol became funded, study terminated, data not collected.||||||
2809456|NCT00455013|Secondary|Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion|Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock.|End of Month 12 to end of Study (Month 48)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form|||participants|||Number
2809457|NCT00455013|Secondary|Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor.|Months 24, 36, 48|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.|||participants|||Number
2809458|NCT00455013|Secondary|Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively.|End of Month 12 to end of Long Term Extension (Year 4)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.|||participants|||Number
2809459|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension|GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted.|Months 24, 36 and 48 post transplantation|N=All participants who were randomized, transplanted, in the LTE and had data available at the specific time point.|||mL/Min/1.73m^2||Standard Deviation|Mean
2809460|NCT00455013|Secondary|Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|End of Month 12 to end of Long Term Extension (Year 4)|N=participants randomized and transplanted and in LTE.|||participants|||Number
2809478|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 24 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)|||Subjects|||Number
2809461|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|End of Month 12 to end of Month 48 Post Transplantation|All participants who completed the short term (ST) period, were eligible and accepted to enter the LTE by signing a new informed consent form.|||participants|||Number
2809462|NCT00455013|Secondary|Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population|Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for > 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|Analysis on both CNI-free and CS-free participants based on all followed up at least 151 days for Month 6 or 347 days for Month 12. One participant in the tacrolimus arm was counted as CNI-free since he discontinued tacrolimus on Day 2 of transplant and no data were available regarding immunosuppressive therapy after discontinuation.|||participants|||Number
2809463|NCT00455013|Secondary|Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population|Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants.|Day 1 through Month 12|For 95% CI within each group, normal approximation was used if N greater than, equal to (>=)5. Otherwise, exact method was used. Numbers of participants analyzed at Month 6 in each arm were 33, 26, 30 and numbers of participants analyzed at Month 12 were 32, 26, 30, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.|||participants|||Number
2809464|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted.|Months 3, 6 and 12 post transplantation|Month 12 n presented above. Calculated GFR, values >180 mL/min/1.73 m2 (beyond upper limit of biologic plausibility)were truncated at 180 mL/min/1.73 m^2. Based on median (SD) GFR of 83 (50).|||mL/min/1.73m^2||Standard Deviation|Mean
2809465|NCT00455013|Secondary|Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population|Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted.|Baseline to Month 12|33, 26, 30 participants were included in the ITT population. Number of participants analyzed for HDL-C = 26, 22, 26; non-HDL-C = 26, 22, 26; LDL-C = 20, 14, 21; TC = 26, 22, 26; triglycerides = 20, 14, 21, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.|||mg/dL||Standard Deviation|Mean
2809466|NCT00455013|Secondary|Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population|Participants using > = 1 antihyperlipidemic medication at Month 12.|Month 12|Analysis based on all participants who were followed up at least 364 days.|||participants|||Number
2809467|NCT00455013|Secondary|Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population|Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted.|Baseline and 12 months post transplantation|Number analyzed at baseline presented above. Number analyzed at Month 12: 28, 22, 29 in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF treatment arms,respectively. Measurements obtained immediately after drug infusion were excluded from analysis.|||mm Hg||Standard Deviation|Mean
2809468|NCT00455013|Secondary|Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population|Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (>)6. Intent to treat population included all participants randomized and transplanted.|Baseline and Month 12|ITT population, 33, 26, 30 for each arm, respectively, was used for each time point (baseline and Month 12). At baseline, 2 participants in each arm were not using at least one medication. 8, 6, and 10 participants in each arm respectively, were not using at least one medication at Month 12.|||participants|||Number
2809491|NCT00454987|Primary|Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
2817687|NCT00399542|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809469|NCT00455013|Secondary|Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population|"Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation.~Intent to treat population included all participants randomized and transplanted."|Baseline to Month 12||||participants|||Number
2809470|NCT00455013|Secondary|Number of Participants With Delayed Graft Function - Intent to Treat Population|Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted|From Day 1 up to and including Day 8 post transplantation||||participants|||Number
2809471|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population|Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 12||||participants|||Number
2809472|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population|Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 6|Intent to treat population included all randomized and transplanted participants.|||participants|||Number
2809473|NCT00455013|Secondary|Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|Day 1 to Month 6 and Month 12 post transplantation|Participants surviving with a functioning graft were 30, 24, 30 in belatacept/MMF, belatacept/sirolimus, tacrolimus/MMF arms, respectively. Participant who died had functioning graft at time of death.|||participants|||Number
2809474|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|For 95% CI within each group, normal approximation was used if N greater than, equal to 5. Otherwise, exact method was used.|||participants|||Number
2809475|NCT00455013|Primary|Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population|AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with >25% of parenchyma affected and moderate tubulitis with >4 mononuclear cells/tubular cross section; IB: >10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells.|Day 1 to Month 6 post-transplantation|Participants with more than one episode of AR were counted once only and the episode with the worst grade was used. For 95% Confidence Interval (CI) within each group, normal approximation was used if N greater than, or equal to (>=) 5. Otherwise, exact method was used. ITT population defined as all randomized and transplanted participants.|||participants|||Number
2809476|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Within (31-Days) at Year 2|The Total Cohort Year 2 included all vaccinated subjects in the booster study 104056 who came back for the Year 2 follow-up and also all subjects of NoBoost Group who were enrolled and vaccinated at Visit 2 (i.e. 40-43 months of age).|||Subjects|||Number
2809477|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 48 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)|||Subjects|||Number
2809479|NCT00454987|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 12 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)|||Subjects|||Number
2809480|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2809481|NCT00454987|Primary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
2809482|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects||95% Confidence Interval|Number
2809483|NCT00454987|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809484|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||µg/mL||95% Confidence Interval|Geometric Mean
2809485|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
2809486|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
2809487|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
2809488|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjetcs|||Number
2809489|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809490|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||µg/mL||95% Confidence Interval|Geometric Mean
2809492|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||µg/mL||95% Confidence Interval|Geometric Mean
2809493|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
2809494|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
2809495|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||µg/mL||95% Confidence Interval|Geometric Mean
2809496|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809497|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809498|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||µg/mL||95% Confidence Interval|Geometric Mean
2809499|NCT00454987|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
2809500|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Titre||95% Confidence Interval|Geometric Mean
2809501|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
2809502|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.|||Subjects|||Number
2809503|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Titre||95% Confidence Interval|Geometric Mean
2809640|NCT00454207|Secondary|The Average Plasma Trough Concentration (Ctrough) of Sildenafil|The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanograms/milliliter||Standard Deviation|Mean
2809504|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Titre||95% Confidence Interval|Geometric Mean
2809505|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809506|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809507|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809508|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.|||Subjects|||Number
2809509|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Titre||95% Confidence Interval|Geometric Mean
2809510|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
2809511|NCT00454987|Primary|Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.|||Subjects|||Number
2809512|NCT00454909|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809513|NCT00454909|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809514|NCT00454909|Secondary|Number of Subjects With New Onset Chronic Illness(es) (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809515|NCT00454909|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 6|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809516|NCT00454909|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after vaccination|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809641|NCT00454207|Secondary|The Average Plasma Concentration (Css,av) of Sildenafil at Steady State|The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanograms/milliliter||Standard Deviation|Mean
2809517|NCT00454909|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809518|NCT00454909|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809519|NCT00454909|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|At Day 0 (PRE) and Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days|||Titers||95% Confidence Interval|Geometric Mean
2809520|NCT00454909|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|At Day 0 (PRE) and Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.|||Participants|||Count of Participants
2809521|NCT00454909|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|At Month 1|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.|||Participants|||Count of Participants
2809522|NCT00454909|Primary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.|At Day 0 (PRE)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.|||Participants|||Count of Participants
2809523|NCT00454857|Secondary|Number of Participants Requiring Splenectomy|The number of participants who required a splenectomy during the 12-month prospective phase of the study.|12 months|All enrolled participants who completed at least 1 observational study visit during the prospective phase.|||Participants|||Number
2809524|NCT00454857|Secondary|Duration of Exposure to ITP Medication|Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase. N=number of participants using each medication.|||Months||Standard Deviation|Mean
2809525|NCT00454857|Secondary|Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase|The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase.|||Participants|||Number
2809526|NCT00454857|Secondary|Change From Baseline to Month 12 in Treatment Satisfaction|Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.|||Units on a scale||Standard Deviation|Mean
2809527|NCT00454857|Secondary|Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0).|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all subjects who completed at least one questionnaire during the prospective observation period.|||Units on a scale||Standard Deviation|Mean
2809528|NCT00454857|Secondary|Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)|The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best).|Baseline to month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.|||Units on a scale||Standard Deviation|Mean
2817688|NCT00399542|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809529|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.|The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809530|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.|The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809531|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.|Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809532|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment|The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809533|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.|The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809534|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Third-line Treatment.|The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809535|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Second-line Treatment.|The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809536|NCT00454857|Primary|Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment|The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants|||Participants|||Number
2809537|NCT00454818|Other Pre-specified|Phase 1 and Phase 2: All Subject Deaths Through 36 Months|"All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under Deaths within 12 months but also listed as Cardiovascular deaths in long-term follow-up. Accordingly, the number of Cardiovascular deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 of the deaths occurred within 12 months but after early termination."|36 months|"Includes all participants enrolled in the Phase 1 or Phase 2 trial. Events occurring after early termination are listed under long-term follow-up. The number of CV deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 deaths occurred within 12 months but after early termination."|||participants|||Number
2809538|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||mL||Standard Deviation|Mean
2809539|NCT00454818|Primary|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||mL||Standard Deviation|Mean
2809540|NCT00454818|Primary|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||Percentage of blood ejected from the LV||Standard Deviation|Mean
2809541|NCT00454818|Other Pre-specified|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||Percentage of blood ejected from the LV||Standard Deviation|Mean
2809542|NCT00454818|Post-Hoc|Phase 2: Selected Clinical Outcomes During 12-month Study Period|Incidences of key clinical endpoints as adjudicated by the blinded Clinical Endpoint Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||percentage of participants|||Number
2809543|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.|||pg/mL||Standard Deviation|Mean
2809544|NCT00454818|Other Pre-specified|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. Peak VO2 data were not available for one patient in the placebo group.|||mL/kg per minute||Standard Deviation|Mean
2809545|NCT00454818|Other Pre-specified|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||meters||Standard Deviation|Mean
2809546|NCT00454818|Other Pre-specified|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).~The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.~For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 12 months|This analysis was performed on the intention to treat population, which included all patients randomized to treatment.|||units on a scale||Standard Deviation|Mean
2809547|NCT00454818|Other Pre-specified|Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||days||Standard Deviation|Mean
2809548|NCT00454818|Primary|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.|||pg/mL||Standard Deviation|Mean
2809549|NCT00454818|Primary|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||mL/kg per minute||Standard Deviation|Mean
2809550|NCT00454818|Primary|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||meters||Standard Deviation|Mean
2809570|NCT00454779|Primary|Progression Free Survival (PFS) During the First-line Treatment Phase|The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)|||Months||95% Confidence Interval|Median
2809551|NCT00454818|Primary|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).~The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.~For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||units on a scale||Standard Deviation|Mean
2809552|NCT00454818|Primary|Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||days||Standard Deviation|Mean
2809553|NCT00454818|Primary|Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months|"Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of TEAEs related to the investigational product (IP) includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP."|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.|||percentage of participants|||Number
2809554|NCT00454805|Secondary|Duration of Clinical Benefit|Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months.|Every 8 weeks until progression or discontinuation||||Days||Standard Deviation|Mean
2809555|NCT00454805|Secondary|Clinical Benefit Rate|"Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months.~The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off."|Every 8 weeks until progression or discontinuation||||Ratio|||Number
2809556|NCT00454805|Secondary|Duration of Response|Number of days from date of response (complete/partial based on RECIST) to date of progression|Every 8 weeks until progression or discontinuation||||Days||Full Range|Median
2809557|NCT00454805|Secondary|Objective Response Rate|"Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as:~Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.~Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.~Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.||||Participants|||Number
2809558|NCT00454805|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.||||Days||95% Confidence Interval|Median
2809559|NCT00454779|Secondary|Overall Survival (OS) for the Second-line Treatment|Time from the first dose of panitumumab monotherapy to the date of death during the entire study|Until death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Months||95% Confidence Interval|Median
2809560|NCT00454779|Secondary|Time to Response (TTR) During the Second-line Treatment Phase|Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Weeks||Standard Deviation|Mean
2809561|NCT00454779|Secondary|Duration of Response (DOR) During the Second-line Treatment Phase|Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Months||95% Confidence Interval|Median
2809583|NCT00454649|Secondary|Plasma Clearance (CL) for Carboplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
2809562|NCT00454779|Secondary|Rate of Disease Control (RDC) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Percentage of Participants||95% Confidence Interval|Mean
2809563|NCT00454779|Secondary|Overall Response Rate (ORR) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Percentage of Participants||95% Confidence Interval|Mean
2809564|NCT00454779|Secondary|Progression Free Survival (PFS) During the Second-line Treatment Phase|The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy|||Months||95% Confidence Interval|Median
2809565|NCT00454779|Secondary|Overall Survival (OS) for the First-line Treatment|Time from the date of randomization to the date of death during the entire study|Until death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)|||Months||95% Confidence Interval|Median
2809566|NCT00454779|Secondary|Time to Response (TTR) During the First-line Treatment Phase|Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Weeks||Standard Deviation|Mean
2809567|NCT00454779|Secondary|Duration of Response (DOR) During the First-line Treatment Phase|Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response|||Months||95% Confidence Interval|Median
2809568|NCT00454779|Secondary|Rate of Disease Control (RDC) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review|||Percentage of Participants||95% Confidence Interval|Mean
2809569|NCT00454779|Secondary|Overall Response Rate (ORR) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review|||Percentage of Participants||95% Confidence Interval|Mean
2809584|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
2809571|NCT00454649|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks|Population included all participants who received at least 1 dose of study medication and had at least 1 target lesion according to RECIST and a baseline assessment of disease.|||Percentage of Participants|||Number
2809572|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Pemetrexed|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809573|NCT00454649|Secondary|Plasma Clearance (CL) for Pemetrexed|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
2809574|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
2809575|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809576|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809577|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Cisplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809578|NCT00454649|Secondary|Plasma Clearance (CL) for Cisplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
2809579|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
2809580|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809581|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin|AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809582|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Carboplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809585|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809586|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809587|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Gemcitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809588|NCT00454649|Secondary|Plasma Clearance (CL) for Gemcitabine|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
2809589|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
2809590|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809591|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809592|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Capecitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809593|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Capecitabine|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Liter/hr||Standard Deviation|Mean
2809594|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).|||ng/mL||Standard Deviation|Mean
2809595|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809596|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809597|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Docetaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809598|NCT00454649|Secondary|Plasma Clearance (CL) for Docetaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
2809601|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809602|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Paclitaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809603|NCT00454649|Secondary|Plasma Clearance (CL) for Paclitaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||L/hr||Standard Deviation|Mean
2809604|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|Cmin was analyzed only for orally administered drugs.|||ng/mL||Standard Deviation|Mean
2809605|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809606|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2809607|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2809608|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Liter/hour (L/hr)||Standard Deviation|Mean
2809609|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).|||ng/mL||Standard Deviation|Mean
2809610|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2809611|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2809612|NCT00454649|Primary|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy|MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]|Safety analysis population included all enrolled participants who received at least 1 dose of study medication.|||mg BID|||Number
2809613|NCT00454636|Secondary|Time to Response|Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.|||days||Standard Deviation|Mean
2809614|NCT00454636|Secondary|Duration of Response|Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.|||days||Standard Deviation|Mean
2809615|NCT00454636|Secondary|Overall Survival (OS)|OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2809616|NCT00454636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2809617|NCT00454636|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2809618|NCT00454636|Primary|Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)||Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.|||percentage of participants|||Number
2809619|NCT00454584|Secondary|Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)|The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive.|Participants who were randomized to ustekinumab, had a PGA score less than or equal to 2 at Week 12, and were retreated upon losing PGA response (PGA greater than or equal to 3).|||Score on a scale||Standard Error|Mean
2809620|NCT00454584|Secondary|Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12|Number of participants achieving greater than or equal to 90 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Baseline and Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. A participant is considered a non-responder if the participant has used any pre-specified prohibited medications, discontinued due to lack of efficacy, or had a missing Week 12 PASI score.|||Participants|||Number
2809621|NCT00454584|Secondary|Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had a missing PGA score.|||Participants|||Number
2809686|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution (Vd/F/Dose) on Day 1|Volume of distribution (Vd/F/dose) were measured on day 1 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 hrs after first dose.|Day 1 of treatment||||mL/mg||Full Range|Median
2809622|NCT00454584|Primary|Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0.|Baseline and Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participants is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or has missing data at Week 12.|||Participants|||Number
2809623|NCT00454571|Secondary|Median PSA Progression-free Survival|Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.|Time from randomization to PSA progression or death from any cause|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to PSA progression.||||||
2809624|NCT00454571|Primary|Median Time to PSA Progression|The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.|Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to disease progression.||||||
2809625|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Independent Radiology Assessment|2 months||||participants|||Number
2809626|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Investigator Assessment|2 Months||||participants|||Number
2809627|NCT00454532|Primary|Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)|Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0|Monthly||||participants|||Number
2809628|NCT00454363|Other Pre-specified|Plasma Trough Level of GW786034||assessed at Baseline and day 28, day 28 reported|Plasma trough level in blood was below the level of detection.|||Participants|||Count of Participants
2809629|NCT00454363|Other Pre-specified|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Baseline to 18 months.|Analysis calculated according to intent to treat.|||months||95% Confidence Interval|Median
2809630|NCT00454363|Secondary|Percent Change in Tumor Blood Flow Assessed by Functional CT|Explore the effect on tumor blood flow as determined by functional CT of GW786034 (Pazopanib) 800 mg orally once daily on both arms, carcinoid and pNET.|Baseline and week 12|Data were not collected from any participant in the Pazopanib + Carcinoid Arm Group|||percentage of change in tumor blood flow||Full Range|Median
2809631|NCT00454363|Primary|Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 18 months|RECIST best protocol response by intention to treat. Four participants were not evaluable for response.|||participants|||Number
2809632|NCT00454324|Secondary|Number of Individuals With Adverse Events|Drug toxicities will be evaluated during treatment period and 30 days post treatment. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) criteria. Grade 3 or 4 adverse events were reported|10 weeks||||Participants|||Count of Participants
2809633|NCT00454324|Secondary|Progression Free Survival (PFS)|Defined as the time between trial enrollment to disease progression or death (whichever occurs first) or date of last contact|Through the end of the study, an average of approximately 8 months||||Months||95% Confidence Interval|Median
2809634|NCT00454324|Secondary|1-year Overall Survival (OS)|Percentage of participants from the start of treatment with the disease that are still alive.|every 12 weeks for 1 year||||percentage of participants||95% Confidence Interval|Number
2809635|NCT00454324|Primary|Overall Response Rate|Radiological imaging should be performed every 12 weeks, to ascertain the overall (or objective) response rate (Complete Response or Partial Response) according to the RECIST guidelines. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Overall Response Rate = CR+PR.|12 weeks||||percentage of participants||95% Confidence Interval|Number
2809636|NCT00454246|Secondary|Number of Participants Assessed for AEs and SAEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|First dose of medication through 15 days post last dose (up to 8 months)|Safety Population|||participants|||Number
2809637|NCT00454246|Secondary|Dose Adjustments|Efficacy analyses were not performed.|5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.||||participants|||Number
2809638|NCT00454246|Primary|Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL|Efficacy analyses were not performed.|6-7 months post initiation of dialysis||||percentage of participants|||Number
2809639|NCT00454207|Secondary|Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality.|Baseline up to 1.3 years|All subjects who received at least one dose of the study medication and had any evaluable laboratory test data after treatment.|||participants|||Number
2809688|NCT00454142|Secondary|Pharmacokinetic Study: AUC0-24h/Dose on Day 1|AUC 0-24h/dose were measured on day 1 for 26 evaluable participants. Blood sampling is done at zero (pre-dose), 0.5 hr, 1, 2, 3, 4, 5, 6 and 8 hrs after the first dose.|Day 1 of treatment||||hr*ng/mL/mg||Full Range|Median
2809642|NCT00454207|Secondary|The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320|The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanogram*hour/milliliter||Standard Deviation|Mean
2809643|NCT00454207|Secondary|Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||hours||Standard Deviation|Mean
2809644|NCT00454207|Secondary|Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing||||nanograms/milliliter||Standard Deviation|Mean
2809645|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II|Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||picograms/milliliter||Standard Deviation|Mean
2809646|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||scores on a scale||Standard Deviation|Mean
2809647|NCT00454207|Secondary|Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||participants|||Number
2809648|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||meters||Standard Deviation|Mean
2809649|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 4, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).|||picograms/milliliter||Standard Deviation|Mean
2809650|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).|||scores on a scale||Standard Deviation|Mean
2809651|NCT00454207|Secondary|Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||participants|||Number
2809652|NCT00454207|Secondary|Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809653|NCT00454207|Secondary|Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809654|NCT00454207|Secondary|Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||percent saturation||Standard Deviation|Mean
2817689|NCT00399542|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809655|NCT00454207|Secondary|Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||percent saturation||Standard Deviation|Mean
2809656|NCT00454207|Secondary|Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
2809657|NCT00454207|Secondary|Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne*second/centimeter^5||Standard Deviation|Mean
2809658|NCT00454207|Secondary|Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
2809659|NCT00454207|Secondary|Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||beats/minute||Standard Deviation|Mean
2809660|NCT00454207|Secondary|Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac index at Week 12 minus cardiac index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||liter/minute/meter^2||Standard Deviation|Mean
2809661|NCT00454207|Secondary|Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809662|NCT00454207|Secondary|Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809663|NCT00454207|Primary|Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac output at Week 12 minus cardiac output at baseline|Baseline, week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||liter/minute||Standard Deviation|Mean
2809664|NCT00454207|Secondary|Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|"Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.~Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline."|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809665|NCT00454207|Secondary|Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809666|NCT00454207|Secondary|Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809667|NCT00454207|Secondary|Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809668|NCT00454207|Secondary|Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809669|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I|"Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.~The 6-minute walk distance:Total distance walked during the 6- minute walk test."|Baseline, Week 8|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline.|||meters||Standard Deviation|Mean
2809670|NCT00454207|Primary|Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||dyne·second/centimeter^5||Standard Deviation|Mean
2809671|NCT00454207|Primary|Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||mmHg||Standard Deviation|Mean
2809672|NCT00454207|Primary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.|||meters||Standard Deviation|Mean
2809673|NCT00454194|Secondary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria."|Up to 5 years|All participants who met the eligibility criteria and started the treatment.|||percentage of participants|||Number
2809674|NCT00454194|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 3 years|All participants who met the eligibility criteria and started the treatment.|||participants|||Number
2809675|NCT00454194|Secondary|Duration of Response|"Duration of response was defined as the time from the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;"|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.|||months||95% Confidence Interval|Median
2809676|NCT00454194|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from date of randomization to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or other medical problems.|Up to 5 years|All participants who met the eligibility criteria and ended the treatment.|||months||95% Confidence Interval|Median
2809677|NCT00454194|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All participants who met the eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
2809678|NCT00454194|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from randomization to the disease progression or death (up to 5 years)|All participants who met the eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
2809679|NCT00454181|Secondary|Investigator Assessment Regarding Global Oral Changes.|"Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment||||participants|||Number
2809680|NCT00454181|Secondary|Investigator Assessment Regarding Changes in Warts|"Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment||||participants|||Number
2809681|NCT00454181|Secondary|Subject Questionnaire Regarding Global Oral Changes|"Number of subjects reporting change in global oral health from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to end of treatment||||participants|||Number
2809682|NCT00454181|Secondary|Subject Questionnaire Regarding Changes in Warts|"Number of subjects reporting change in oral warts from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to the end of treatment||||participants|||Number
2809683|NCT00454181|Secondary|Total Surface Area of the Lips Covered by Warts|Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area|24 weeks, from baseline to the end of treatment|Per protocol - only a sub-set of subjects had lip warts at study entry|||participants|||Number
2809684|NCT00454181|Primary|Change in Total Oral Mucosal Area Covered by Warts.|Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area|24 weeks, from baseline to the end of treatment|Per protocol|||participants|||Number
2809685|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution at Steady State (Vss/F/Dose) on Day 28|Volume of distribution at steady state (Vss/F/Dose) were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment||||mL/mg||Full Range|Median
2809689|NCT00454142|Secondary|Pharmacokinetic Study: Percentage of Participants With Trough Concentration at Steady State (Day 28) Above 15 µg/mL|Pazopanib pharmacokinetic parameters were estimated on Day 1 and Day 28 (steady state). Trough concentration of pazopanib was measured on Day 28 with blood sampling at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after Day 28 dose.|Day 28 of treatment|Patients (total 26) with both Day 1 and Day 28 pharmacokinetic parameters were included.The trough concentration of pazopanib on Day 28 was observed to be above 15ug/ml in approximately 92% of patients at steady state.|||percentage of participants|||Number
2809690|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow on Day 28|DCE-CT was performed on Day 28 and tumor blood flow was measured. 19 of 33 patients had evaluable DCE-CT data.|28 days post treatment||||ml/100ml/min||Standard Deviation|Mean
2809691|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow at Baseline|Dynamic-contrast enhanced computed tomography (DCE-CT) was performed at baseline and Day 28, tumor blood flow was measured.19 of 33 patients had evaluable DCE-CT data.|Pretreatment||||ml/100ml/min||Standard Deviation|Mean
2809692|NCT00454142|Secondary|Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE)|The frequencies of grade 3/4 related toxicities were recorded among all participants, and the percentage of participants who experienced significant AEs were reported.|From the time of first treatment with pazopanib hydrochloride to up to 30days after completion of treatment||||percentage of participants|||Number
2809693|NCT00454142|Secondary|Overall Survival||From date of enrollment to the study to the date of death from any cause or to the date when the patient was last known to be alive, up to 3 years.||||months||95% Confidence Interval|Median
2809694|NCT00454142|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST ver 1.0) and assessed by CT or MRI. CBR includes 1) Complete response (CR): disappearance of all lesions; 2) partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions and 3) stable disease (SD): non-PR and non progressive disease.|12 weeks of treatment||||percentage of participants||95% Confidence Interval|Number
2809695|NCT00454142|Secondary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by RECIST Committee. The sample proportion and associated 95% confidence interval will be reported.|From the date of enrollment to the date of first documented progression or death, whichever occurs first, or to the date when the patient was last known to be alive, up to 3 years.||||months||95% Confidence Interval|Median
2809696|NCT00454142|Secondary|Response Rate (PR)|Per response evaluation criteria in solid tumors (RECIST v1.0) and assessed by MRI or CT: Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-PD (PD: progressive disease) of non-target lesions.|12 weeks of treatment||||percentage of participants|||Number
2809697|NCT00454116|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days)||||Participants|||Number
2809698|NCT00454051|Secondary|Physician's Overall Assessment of Treatment Effectiveness|The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening)|After 16 weeks of treatment|The ITT population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. Complete data for 26 of the total 30 participants was recorded.|||participants|||Number
2809699|NCT00454051|Secondary|Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)|Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||liters per minute||Standard Deviation|Mean
2809700|NCT00454051|Secondary|Change From Baseline in the Number of Unscheduled Clinic Visits|Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||unscheduled visits||Standard Deviation|Mean
2809701|NCT00454051|Secondary|Change From Baseline in the Number of Days With Hospitalizations|Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days||Standard Deviation|Mean
2809702|NCT00454051|Secondary|Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms|Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days||Standard Deviation|Mean
2809703|NCT00454051|Secondary|Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week|"Impairment was defined as days with physical activity considered as limited (or not normal) according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16)."|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days per week||Standard Deviation|Mean
2809704|NCT00454051|Secondary|Change From Baseline in the Number of Nights With Awakenings Per Week|Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||nights with awakenings per week||Standard Deviation|Mean
2809705|NCT00454051|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Week|Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||puffs per week||Standard Deviation|Mean
2809706|NCT00454051|Primary|Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.|||percent change in fluorescence intensity||Standard Deviation|Mean
2809707|NCT00454051|Secondary|Change From Baseline in the Number of Days With Asthma Symptoms Per Week|Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.|||days per week||Standard Deviation|Mean
2809708|NCT00454051|Secondary|Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12, and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.|||% change in fluorescence intensity||Standard Deviation|Mean
2809709|NCT00454051|Secondary|Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12 and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.|||percent change in cells expressing FcεRI||Standard Deviation|Mean
2809710|NCT00454051|Primary|Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.|||percent change in FcεRI expression||Standard Deviation|Mean
2809711|NCT00453999|Secondary|Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)|Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.|Baseline, and 12, 24, 36, 48, 72, and 96 hours|Among the 122 subjects with confirmed influenza (intent-to-treat infected [ITTI]) population, a total of 112 subjects had positive virus cultures obtained from baseline nasopharyngeal specimens.|||log10 TCID50/mL||Standard Deviation|Mean
2809712|NCT00453999|Secondary|Time to Hospital Discharge (Kaplan-Meier Estimate)|Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||hours||95% Confidence Interval|Median
2809713|NCT00453999|Secondary|Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)|The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||participants|||Number
2809714|NCT00453999|Secondary|Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)|Changes in each subject's ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject's ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||hours||95% Confidence Interval|Median
2809715|NCT00453999|Secondary|Change From Baseline in Scores of Symptoms of Influenza|Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue, each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]) were tabulated by treatment group. Missing data were excluded.|Baseline, Days 2, 3, 4, 5, 10, and 14|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||units on a scale||Standard Deviation|Mean
2809716|NCT00453999|Primary|Time to Clinical Stability (Kaplan-Meier Estimate)|Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.|||hours||95% Confidence Interval|Median
2809717|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809718|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort|An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809719|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809738|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2809720|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809721|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort|AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809722|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809723|NCT00453986|Secondary|Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809724|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809725|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809726|NCT00453986|Secondary|Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809727|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort|Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = > 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809728|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature > 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809729|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.|During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2817690|NCT00399542|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809730|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after meningococcal vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809731|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2809732|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2809733|NCT00453986|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809734|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2809735|NCT00453986|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809736|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2809737|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort|Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809758|NCT00453921|Primary|Change in Anterior Cingulate Gyrus Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention|Change from pre- to post-treatment in brain activation in the anterior cingulate region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.|pre- to post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
2809739|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809740|NCT00453986|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer >1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809741|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2809742|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809743|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2809744|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809745|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to vaccination (at Month 0).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2809746|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809747|NCT00453986|Primary|Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809748|NCT00453986|Primary|Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Fold increase in serum HI GMTs||95% Confidence Interval|Mean
2809749|NCT00453986|Primary|Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|"Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer >1:40, or a pre-vaccination titer >1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain.~Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B."|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809750|NCT00453986|Primary|Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2809751|NCT00453986|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2809752|NCT00453986|Primary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Participants|||Count of Participants
2809753|NCT00453986|Primary|Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2809754|NCT00453973|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change|||percentage of participants|||Number
2809755|NCT00453921|Secondary|Self Report Questionnaire - MASQ|The Multiple Abilities Questionnaire (self rating) is a questionnaire in which participants can identify deficits/complaints in the areas of language, visual perception, verbal memory, visual memory and attention and concentration. A total score is calculated; range is 30-130. Higher scores indicate greater level of complaints (worse outcome). For the purposes of this study, a score one standard deviation above the mean (102.7) indicated significant reported cognitive complaints.|post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
2809756|NCT00453921|Primary|Change in Right Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention|Change from pre- to post-treatment in brain activation in the right inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.|pre- to post-treatment (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
2809757|NCT00453921|Primary|Change in Left Middle/Inferior Frontal Activation During Working Memory Processing (3-back > 0-back Condition) From Baseline to Post-intervention|Change from pre- to post-treatment in brain activation in the left middle/inferior frontal region of interest in arbitrary units provided by the SPM (statistical parametric mapping) program (range: unknown). Higher scores indicate greater increase in activation from pre- to post-treatment.|pre- to post-treatment (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
2809821|NCT00453336|Primary|Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment|Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.|6 months||||participants|||Number
2809759|NCT00453921|Primary|Functional MRI Task Performance and Brain Activation (Change From Baseline to Post-treatment)|Change in performance (percent correct,adjusted for guessing) from pre-(baseline) to post-treatment (approximately 7 weeks) for in-scanner n-back working memory task (Range: 0-100). Higher scores means better performance.|pre- to post-6 week treatment intervention (at least 7 weeks)||||percentage of correct targets (adjusted)||Standard Deviation|Mean
2809760|NCT00453921|Primary|Neuropsychological Assessment - CPT, Distractibility Condition (Reaction Time)|Continuous Performance Test, Distractibility Condition (Reaction Time in msecs) (range: 0-800). Higher score is worse performance.|post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
2809761|NCT00453921|Primary|Neuropsychological Assessment, CVLT-II|Memory measure: California Verbal Learning Test, 2nd edition (CVLT), Total, trials 1-5 (range: 0-80). Higher scores are better outcome.|post-intervention (at least 7 weeks)||||units on a scale||Standard Deviation|Mean
2809762|NCT00453895|Secondary|Assessment of Toxicity|Adverse events were rated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (see http://ctep.cancer.gov/reporting/ctc.html).|up to 400 days||||number of adverse events/patient||Full Range|Median
2809763|NCT00453895|Secondary|Assessment of Overall Survival|Overall Survival was defined as time from start of treatment until death or last follow-up.|up to 36 months||||monhts||95% Confidence Interval|Median
2809764|NCT00453895|Secondary|Assessment of Progression-free Survival|Progression-free survival is defined as time of start of study until documentation of Progress. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 400 days||||days||95% Confidence Interval|Median
2809765|NCT00453895|Secondary|Assessment of Objective Response Rates|Objective Response Rate defined by RECIST 1.0|12 weeks||||Participants|||Count of Participants
2809766|NCT00453895|Primary|Assessment of Clinical Benefit Due to Treatment With Sunitinib|Clinical benefit was defined as stable disease or better for at least 12 weeks|12 weeks||||Participants|||Count of Participants
2809767|NCT00453479|Secondary|Derived Urine PK Parameters-area Under Concentration-renal Clearance (Clr)|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used. Only those participants available at the specified time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2809768|NCT00453479|Secondary|Derived Urine PK Parameters-area Under Concentration-fraction of Dose Excreted Unchanged in Urine (Fe)|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data presented as 0-12 hours and 12-24 hours. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used.|||Percentage of dose||Standard Deviation|Mean
2809769|NCT00453479|Secondary|Derived Urine Pharmacokinetic (PK) Parameters-area Under the Plasma Concentration-amount of Drug Excreted Unchanged in Urine (Ae)|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data presented as AM dose and PM dose. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used.|||Nanogram||Geometric Coefficient of Variation|Geometric Mean
2809770|NCT00453479|Secondary|Derived PK Plasma Parameters-area Under Concentration-time of Maximum Observed Plasma Concentration (T-max), Half-life (T-half) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning and evening samples.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Hour||Full Range|Median
2809771|NCT00453479|Secondary|Derived PK Plasma Parameters-area Under Concentration-maximum Observed Plasma Concentration (Cmax)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning and evening samples as adjusted geometric mean.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Nanograms per liter||90% Confidence Interval|Geometric Mean
2809772|NCT00453479|Secondary|Derived Plasma PK Parameters-area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning sample as adjusted geometric mean.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Hour×Nanograms per milliliter||90% Confidence Interval|Geometric Mean
2809773|NCT00453479|Secondary|Derived Plasma PK Parameters-area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau)|Blood samples were collected at indicated time points. 12 hour PK sampling was before evening dose. Data presented for morning samples.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used.|||Hour×Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2809774|NCT00453479|Secondary|Urine Concentrations of GSK233705|Urine GSK233705 pharmacokinetic excretion rate-time data is presented. Urine samples were collected throughout study and consolidated data is presented as 0-12 hours and 12-24 hours. 12 hour pharmacokinetic sampling was before evening dose.|Day 1 and 7 throughout 24 hours|PK population was used.|||Nanograms per liter||Standard Deviation|Mean
2809775|NCT00453479|Secondary|Plasma Concentrations of GSK233705|Blood samples were collected at indicated time points. 12 hour pharmacokinetic (PK) sampling was before evening dose.|Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose|PK population was used; this was defined as all participants in the all subjects population for whom a PK sample was obtained and analyzed.|||Nanograms per milliliter||Standard Deviation|Mean
2809776|NCT00453479|Primary|Summary of Mean (0-24 Hour) and Maximum (0-24 Hour) Heart Rate Measured Using 24 Hour Using Holter ECG Data|Holter monitors were switched on immediately prior to dosing (up to 15mins pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. It was assessed on Day 1 and 7.|Up to Day 7|All subject population was used.|||Beats per minute||95% Confidence Interval|Least Squares Mean
2809777|NCT00453479|Primary|Summary of Microscopy Data for Participants With Abnormal Urinalysis Dipstick Results|Urinalysis parameters included protein, blood, ketones, glucose, bilirubin, urobilinogen, leukocyte esterase, specific gravity, nitrites and pH. Sediment microscopy was performed only on urine samples showing an abnormality on the dipstick. Microscopy was performed for: WBC, RBC, hyaline casts, granular casts and cellular casts. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours).|Up to Day 7 (pre dose)|All subject population was used.|||Participants|||Count of Participants
2809778|NCT00453479|Primary|Number of Participants With Abnormalities in Hematology Data of Clinical Concern|Hematology parameters included platelet count, red blood cell (RBC) count, mean corpuscular volume (MCV), total neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours). Data for parameters with above and below the PCI is provided.|Up to Day 7|All subject population was used.|||Participants|||Count of Participants
2809779|NCT00453479|Primary|Number of Participants With Abnormalities in Chemistry Data of Clinical Concern|Clinical chemistry parameters included urea, potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, creatine kinase, chloride, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyltransferase (GGT), albumin, sodium, phosphorus inorganic, calcium, alkaline phosphatase (ALP) and total protein. It was assessed on Day 1 (pre-dose, 24 hours) and Day 7 (pre-dose, 24 hours). Data for parameters with above and below the potential clinical concern (PCI) is provided.|Up to Day 7|All subject population was used.|||Participants|||Count of Participants
2809780|NCT00453479|Primary|Number of Participants Who Used Rescue Medication|Inhaled salbutamol was used as a rescue medication. Participants were required to keep a diary of their rescue medication (total number of salbutamol doses taken) over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Days 1, 2, 7 and 8.|Up to Day 7|All subject population was used.|||Participants|||Count of Participants
2809781|NCT00453479|Primary|Summary of Mean Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|It was assessed on 1, 2, 4, 9, 12 and 24 hours on Days 1 and 7. Also on Day 7, it was measured on 0 hour (Baseline). At all time points 3 measurements were taken and formal statistical analysis was carried out on the derived maximum readings. Data for adjusted mean is presented as least square mean.|Up to Day 7 (24-hour post dose)|All subject population was used.|||Liters||95% Confidence Interval|Least Squares Mean
2809782|NCT00453479|Primary|Weighted Mean (0-4 h) for the Morning Dose of ECG Parameters QTcF and QTc B|Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Milliseconds||95% Confidence Interval|Least Squares Mean
2809783|NCT00453479|Primary|Maximum Value (0-4 Hour) for the Morning Dose of ECG Parameters Corrected According to Fredericia's Formula (QTcF) and Corrected According to Bazett's Formula (QTc B)|Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Milliseconds||95% Confidence Interval|Least Squares Mean
2809784|NCT00453479|Primary|Number of Participants With Abnormal 12-lead ECG Findings|Single measurements were taken at all time points. The pre-dose values were classed as Baseline. Data for number of participants with normal, abnormal not clinically significant and abnormal clinically significant is presented. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7.|Up to Day 7 (24 hour post dose)|All subject population was used. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2809785|NCT00453479|Primary|Weighted Mean of Heart Rate (0-4 Hour) for the Morning Dose|Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Beats per minute||95% Confidence Interval|Least Squares Mean
2809786|NCT00453479|Primary|Weighted Mean of SBP and DBP (0-4 Hour) for the Morning Dose|Blood pressure was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Millimeters of mercury||95% Confidence Interval|Least Squares Mean
2809787|NCT00453479|Primary|Maximum Value of Heart Rate (0-4 Hour) for the Morning Dose|Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population was used.|||Beats per minute||95% Confidence Interval|Least Squares Mean
2809788|NCT00453479|Primary|Maximum Value of SBP and DBP (0-4 Hour) for the Morning Dose|Blood pressure was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on pre-dose, 15, 30 minutes, 1.5 and 4 hours on Day 1 and 7. Data for adjusted mean is presented as least square mean.|Up to Day 7 (0-4 hour)|All subject population|||Millimeters of mercury||95% Confidence Interval|Least Squares Mean
2809789|NCT00453479|Primary|Summary of Mean Heart Rate|Heart rate was measured subsequent to 12 lead ECG. Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7.|Up to Day 7 (24 hour post dose)|All subject population was used.|||Beats per minute||Standard Deviation|Mean
2809790|NCT00453479|Primary|Summary of Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured subsequent to 12 lead electrocardiogram (ECG). Baseline was defined as the mean of the three planned pre-dose measurements. It was assessed on Baseline (triplicate), 15, 30 minutes, 1.5, 4, 8 and 24 hours on Day 1 and 7.|Up to Day 7 (24 hours post-dose)|All subject population was used.|||Millimeters of mercury||Standard Deviation|Mean
2809822|NCT00453310|Primary|Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment||2 years||||participants|||Number
2809791|NCT00453479|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to follow-up (approximately 45 days)|All subject population included all available data on participants who had received at least one dose of study medication (including placebo).|||Participants|||Count of Participants
2809792|NCT00453388|Secondary|Incidence of Adverse Events|Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria|Up to Day 100|No subjects meeting the criteria for Arms I or IV were enrolled.|||Participants|||Count of Participants
2809793|NCT00453388|Secondary|Incidence of Transplant-related Mortality|Number of subjects who expired due to transplant-related mortality|Up to Day 200|No subjects meeting the criteria for Arms I or IV were enrolled.|||Participants|||Count of Participants
2809794|NCT00453388|Primary|Incidence of Grades III-IV Acute GVHD|"Number of subjects who developed maximum grade acute graft-vs-host disease~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma with bullous formation and often with desquamation~Liver:~- bilirubin 2.0 - 3.0 mg/100 mL~- bilirubin 3 - 5.9 mg/100 mL~- bilirubin 6 - 14.9 mg/100 mL~- bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Up to Day 100|No subjects meeting the criteria for Arms I or IV were enrolled.|||Participants|||Count of Participants
2809795|NCT00453388|Primary|Number of Patients Who Engraft at Each Dose of TBI Used|Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism.|Up to Day 200|No subjects meeting the criteria for Arms I or IV were enrolled.|||Participants|||Count of Participants
2809796|NCT00453362|Secondary|Number of Participants With Adverse Events Due to FLT-PET Imaging|The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.|From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.|Patients with non−small cell lung cancer (NSCLC) who underwent FLT-PET scans.|||Participants|||Number
2809797|NCT00453362|Primary|Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans of <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|||months||Full Range|Median
2809798|NCT00453362|Primary|Overall Survival of Groups by FLT Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.|||months||Full Range|Median
2809799|NCT00453362|Primary|Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."|||months||Full Range|Median
2809800|NCT00453362|Secondary|FLT Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <−25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2809823|NCT00453206|Secondary|Treatment-related Mortality at 100 Days After Transplantation||100 days|||||||
2809824|NCT00453206|Secondary|Quality of Life at the Time of Transplantation||baseline|||||||
2809801|NCT00453362|Secondary|FDG Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <−25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FDG−Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2809802|NCT00453362|Primary|Overall Survival of Groups by FDG Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.|||months||Full Range|Median
2809803|NCT00453362|Primary|Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."|||weeks||Full Range|Median
2809804|NCT00453362|Primary|Progression Free Survival of Groups by FLT Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.|||weeks||Full Range|Median
2809805|NCT00453362|Secondary|Percentage of Patients With FLT-PET Responses|"In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2809806|NCT00453362|Primary|PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <−25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."|||weeks||Full Range|Median
2809807|NCT00453362|Secondary|Percentage of Patients With FDG-PET Responses|"In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%.~CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2809808|NCT00453362|Primary|Progression Free Survival (PFS) of Groups by FDG Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.|||weeks||Full Range|Median
2809809|NCT00453349|Secondary|Number of Subjects Who Received Alternative Medicine|As alternative medicine any systemic antibacterial medication was considered.|Up to 42 days after end of treatment|The number of subjects who received alternative medicine in the PP population was analyzed. The clinical response was graded as alternative medicine (clinical cure, improvement, continued clinical cure) versus no alternative medicine.|||participants|||Number
2809810|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.|||participants|||Number
2809811|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit Microbiologically Valid|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.|||participants|||Number
2809812|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Intent To Treat Population|"All successfully treated subjects and subjects evaluated asindeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes."|28 - 42 days after completion of study drug therapy|At the follow-up visit, the clinical response in subjects who were non-failures at the TOC visit were graded as Continued cure, Clinical relapse or Indeterminate.|||participants|||Number
2809813|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Per Protocol Population|Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.|28 - 42 days after completion of study drug therapy|"All successfully treated subjects and subjects evaluated as indeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow up visit. Patients with missing or indeterminate outcome were omitted."|||participants|||Number
2809814|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism|Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.|7 - 14 days at TOC visit|Patients were included in this analysis if a causative organism could be established pre-therapy by culture or PCR, and if the patient was valid for intent-to-treat.|||participants|||Number
2809815|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid|The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.|7 - 14 days at TOC visit|All subjects for whom a specific bacterial pathogen was isolated/identified from any pre-treatment culture and which was considered responsible for the infection would be assessed for bacteriological efficacy.|||participants|||Number
2809816|NCT00453349|Secondary|Clinical Response on Treatment for Intent To Treat Population|Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.|4 - 7 days after start of therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis.|||participants|||Number
2809817|NCT00453349|Secondary|Clinical Response on Treatment for Per Protocol Population|At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).|4 - 7 days after start of therapy|Analysis was performed for the per protocol population.|||participants|||Number
2809818|NCT00453349|Secondary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population|"For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to non-success."|7 - 14 days after completion of study drug therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis.|||participants|||Number
2809819|NCT00453349|Primary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population|Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.|7 - 14 days after completion of study drug therapy|The number of subjects in the PP population was slightly higher than the planned number of subjects (184 subjects per treatment group). The most common reasons for exclusion from the population valid for efficacy in both the Moxifloxacin and Comparator were essential data missing/invalid, followed by violation of inclusion/exclusion criteria.|||participants|||Number
2809820|NCT00453336|Primary|Number of Participants Experiencing Adverse Events|Number of participants enrolled experiencing serious adverse events and/or other non-serious events|6 months||||participants|||Number
2809831|NCT00453193|Primary|Number of Participants With Objective Response|Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.|After a maximum of 6 months of therapy maintained for one month.|Analysis was per protocol.|||Participants|||Number
2809832|NCT00453180|Secondary|Vineland Adaptive Behavior Scales-II (VABS-II)|The VABS-II is a semi-structured interview designed to assess adaptive functioning in the domains of communication, daily living skills and socialization. Items in each domain are rated as either 0 (does not), 1(sometimes) or 2(independently) performs a given behavior or skill. The communication domain has 99 items with scores ranging from 0-198. The daily living skills domain has 109 items with scores ranging from 0-218. The socialization domain has 99 items with scores ranging from 0-198. The domains scores are combined to form the adaptive composite score (ranging from 20-160). The raw scores from the communication, daily living skills and socialization domains along with the composite score were selected for use in this study. Higher scores indicate a higher level of adaptive functioning.|Week 12||||units on a scale||Standard Deviation|Mean
2809833|NCT00453180|Secondary|Pervasive Developmental Disorder Behavior Index|The PDD Behavior Inventory (PDDBI) is a rating scale filled out by caregivers or teachers that was designed to assess children having a Pervasive Developmental Disorder (PDD; autism, Asperger disorder, PDD-NOS, or childhood disintegrative disorder). Both adaptive and maladaptive behaviors are assessed in the scale, making it useful for treatment studies in which decreases in maladaptive behaviors and improvements in adaptive social and language skills relevant to PDD are expected.|Week 12|Less than 25% of participants in each group received a score on the PDDBI due to a significant floor effect. As a result, the data for these participants are not considered reliable given the significant floor effect.||||||
2809834|NCT00453180|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale (SRS) is a 65-item scale that assesses social impairment in the aspects of social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 0 (not true) to 3 (almost always true). The total SRS raw score may range from 0-195, where higher scores indicate greater severity.|Week 12||||units on a scale||Standard Deviation|Mean
2809835|NCT00453180|Secondary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each of the 58 items are rated from 0 (not at all) to 3 (severe).The ABC has 5 subscales: Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Lethargy (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe). Higher scores indicate a higher level of maladaptive behavior.|Week 12||||units on a scale||Standard Deviation|Mean
2809836|NCT00453180|Primary|Clinical Global Impression - Improvement|"Clinical Global Impression - Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment.~The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved, 3=minimally Improved, 4=no change, 5=minimally worse, 6= much worse and 7=very much worse). Participants with a CGI-I score of 1 or 2 were classified as improved. Participants with a CGI score of 3, 4 or 5 were classified as no response. No participants scored 6 or 7."|Week 12||||Participants|||Count of Participants
2809837|NCT00453180|Primary|Clinical Global Impression - Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Week 12||||Participants|||Count of Participants
2809838|NCT00453154|Other Pre-specified|Change in Plasma Levels of PDGF|Correlated with clinical outcome (response and survival).|Baseline to within 7 days of sunitinib/placebo therapy discontinuation|||||||
2809839|NCT00453154|Other Pre-specified|Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate|The frequency of tumor response by the optimally dichotomized VEGF levels will be tabulated and their association will be tested by Fisher's exact test as well as the maximally selected rank test. The association of the VEGF levels as continuous predictor with tumor response will be tested by Wilcoxon rank sum test. Further assessments of the association of the VEGF levels as > continuous or binary variables and the tumor response will be implemented in a logistic regression while adjusting for other covariates such as performance status, weight loss and age|Baseline to within 7 days of sunitinib/placebo therapy discontinuation|||||||
2809840|NCT00453154|Secondary|Number of Participants With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.|Up to 3 years|Participants who were randomized to maintenance were analyzed.|||participants|||Number
2809841|NCT00453154|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.|||months||95% Confidence Interval|Median
2809842|NCT00453154|Primary|Progression-free Survival (Phase II)|Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.|||months||95% Confidence Interval|Median
2812348|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2809843|NCT00453154|Primary|Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)|The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy).|21 days|Due to safety concerns, the study committee discontinued sunitinib from combination chemotherapy to study single agent sunitinib in the maintenance setting.|||mg/day|||Number
2809844|NCT00453102|Secondary|Number of Participants With Unacceptable Toxicity.|Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.|Up to 12 weeks post-therapy||||participants|||Number
2809845|NCT00453102|Secondary|5 Year Rate of Overall Survival (5-Year OS)|Percentage of participants still alive five years after the date of protocol therapy initiation.|5 Years||||percentage of participants||90% Confidence Interval|Number
2809846|NCT00453102|Secondary|Overall Survival (OS) Rate|The time from the date of initiation of study treatment until date of death from any cause for all participants.|End of Study|Median overall survival by Kaplan-Meier method for all patients was not attained.|||months|||Number
2809847|NCT00453102|Secondary|5-Year Rate of Progression-Free Survival (5-Year PFS)|Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.|5 Years||||percentage of participants||90% Confidence Interval|Number
2809848|NCT00453102|Secondary|Rate of Progression-Free Survival|The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.|End of study.||||months||Full Range|Median
2809849|NCT00453102|Primary|Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.|The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.|12 weeks post-therapy||||percentage of participants||90% Confidence Interval|Number
2809850|NCT00453063|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||liters/minute||Standard Deviation|Least Squares Mean
2809851|NCT00453063|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.|||units on a scale||Standard Deviation|Least Squares Mean
2809852|NCT00453063|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||units on a scale||Standard Deviation|Least Squares Mean
2809853|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||units on a scale||Standard Deviation|Least Squares Mean
2809854|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.|||units on a scale||Standard Deviation|Least Squares Mean
2809855|NCT00452868|Primary|Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks|Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.|24 weeks||||units on a scale||Standard Deviation|Mean
2810134|NCT00450450|Secondary|Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)|Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.|Up to 3 months|One patient is inevaluable and is excluded from analysis.|||Percentage of patients|||Number
2809856|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose(12 months of age)|Safety population: all participants who received toddler dose vaccination (12 months of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809857|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received dose 3 of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809858|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received dose 2 of the infant series vaccination (10 weeks of age); n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809859|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received at least dose 1 of the infant series vaccination (after 6 weeks. n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809860|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (12 months of age)|Safety population: all participants who received toddler dose vaccination(after 12 months). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809861|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809862|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809863|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.|||Percentage of participants|||Number
2809864|NCT00452790|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.|1 month after toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2809882|NCT00452543|Primary|Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)|Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.|From baseline visit to Week 12 (or early discontinuation visit)||||Scores on a scale||Standard Deviation|Mean
2809865|NCT00452790|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||Percentage of participants||95% Confidence Interval|Number
2809866|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2809867|NCT00452790|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.|1 month after the 3-dose infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2809868|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.|||Percentage of participants||95% Confidence Interval|Number
2809869|NCT00452699|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population|||attacks per participant per year||95% Confidence Interval|Mean
2809870|NCT00452699|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided|||Percentage of symptom-free days||Standard Error|Mean
2809871|NCT00452699|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values|||Liters/minute (L/min)||Standard Error|Mean
2809872|NCT00452699|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||Liters||Standard Error|Mean
2809873|NCT00452673|Secondary|Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|CTC, Version 3 used to assess parameters. (ULN)=upper limit of normal: (ALT)= alanine transaminase; (AST)=aspartate aminotransferase; (ALP)=alkaline phosphatase. ALT Grade (Gr)1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10.0*ULN; Gr 4: >10.0*ULN. ALP (U/L) Gr1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Gr 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Gr 3: < 2 g/dL to <2 g/L. Participants with a baseline chemistry lab value of Gr 0 but who had Gr 3 - 4 chemistry value while on-study are presented below.|Day 1 to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.|||participants|||Number
2810135|NCT00450450|Secondary|Estimated Graft Failure Rate|Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.|Up to 10 years|One patient is inevaluable for EFS on experimental arm and is excluded from analysis.|||Percentage of patients|||Number
2809874|NCT00452673|Secondary|Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|National Cancer Institute Common terminology criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN). CTC criteria: Absolute neutrophil count (ANC). Leukocytes (White blood cells) Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Participants with a baseline hematology lab value of Gr 0 but who had Gr 3 - 4 hematology value while on-study are presented below.|Day 1 up to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.|||participants|||Number
2809875|NCT00452673|Secondary|Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population|Objective response rate was the percentage of participants, (n/N; number with objective response per Number evaluated) whose best response is either a Complete Response (CR) or a Partial Response (PR). Disease control rate was defined as percentage (n/N) of participants with stable disease greater than (>) 6 months, PR, or CR. Efficacy Evaluable Population: All participants with at least one measurable lesion at baseline, who received at least one dose of combination study drug and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stop treatment prior to tumor assessment for reasons unrelated to disease or drug were excluded.|Day 1 up to 30 days post last dose|n=number of participants with ORR: 2, 1, 0, 6 in dosing arms 1, 2, 3, and 4, respectively. n= number of participants with Disease control: 3, 2, 2, 14 in dosing arms 1, 2, 3, and 4, respectively.|||percentage of participants||95% Confidence Interval|Number
2809876|NCT00452673|Secondary|Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population|Complete Response (CR): disappearance of all target and non-target lesions, with confirmation at >=4 weeks interval; Partial Response (PR): >= 30% decrease in sum of longest diameter (LDs) of target lesions, taking as reference the baseline sum LD, with confirmation at >= 4 weeks interval. Progressive Disease (PD): Appearance of new lesion(s), or >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, without unequivocal progression of non-target lesions, after >=6 weeks on study. Radiological tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) occurred every 6 weeks. For those patients who were on treatment > 24 weeks, the tumor assessment occurred every 9 weeks.|Day 1 to 30 days post last dose|All participants with at least one measurable lesion at baseline, who received at least one dose of the combination therapy and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stopped drug prior to tumor assessment for reasons unrelated to disease or drug were excluded.|||participants|||Number
2809877|NCT00452673|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population|Adverse events (AEs) were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious AE (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Day 1 up to 30 days post last dose|Safety Population: all participants receiving at least one dose of study drug.|||participants|||Number
2809878|NCT00452673|Primary|Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population|Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.|Day 1 to 30 days post last dose|Safety Population: All participants who received at least one dose of study drug. DLTs: Grade 3 headache, Grade 3 pneumonia, Grade 3 diarrhea in Dosing arms, 1, 2, and 3, respectively. DLTs in dose arm 4: 1 participant with Grade 3 pneumonia and pain and 1 participant with Grade 4 neutropenia and diarrhea plus Grade 3 vomiting and mucositis.|||participants|||Number
2809879|NCT00452543|Primary|Total Drinks Consumed Per Drinking Day on the TLFB|Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)||||Drinks consumed per drinking day||Standard Deviation|Mean
2809880|NCT00452543|Primary|Total Drinks Consumed Per Week on the TLFB|Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)||||Drinks consumed per week||Standard Deviation|Mean
2809881|NCT00452543|Primary|Total Drinking Days on the Alcohol Timeline Followback (TLFB)|The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|Intent to treat sample|||Drinking days||Standard Deviation|Mean
2809883|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)|preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements|||Participants|||Number
2809884|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRx<LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx<LLN use <0.9*preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; bicarbonate (mEq/L): <0.75*LLN or >1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRx<LLN use <0.9 *preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <0.9*LLN or >1.1*ULN, or if preRx <LLN use 0.9*preRx or >ULN if preRx >ULN use 1.1*preRx or <LLN; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements|||Participants|||Number
2809885|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx <LLN, use <0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements|||Participants|||Number
2809886|NCT00452530|Secondary|Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs.|Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2809887|NCT00452530|Primary|Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug|The primary efficacy data set (all randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, an adjudicated venous thrombolytic event; or died due to any cause.)|||Percentage of events/patients evaluated||95% Confidence Interval|Number
2809888|NCT00452530|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM|Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment.|Days 1 to 12|All participants who received at least 1 dose of study drug|||Percentage of events/patients evaluated||95% Confidence Interval|Number
2809899|NCT00452400|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and day 29|Treated set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||mmol/L||Inter-Quartile Range|Geometric Mean
2817691|NCT00399542|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2809889|NCT00452530|Secondary|Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period|||Percentage of events/patients evaluated||95% Confidence Interval|Number
2809890|NCT00452452|Primary|Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2809891|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine.|||percentage of participants|||Number
2809892|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine.|||percentage of participants|||Number
2809893|NCT00452452|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2809894|NCT00452426|Secondary|Recovery Time (From Sedation)|Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.|"from scope out until first of two consecutive MOAA/S scores of 5"|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||minutes||Standard Deviation|Mean
2809895|NCT00452426|Secondary|Clinician Satisfaction|Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|Post procedure|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||Scores on a scale||95% Confidence Interval|Mean
2809896|NCT00452426|Secondary|Patient Satisfaction|Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|24-48 hours post sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||Scores on a scale||95% Confidence Interval|Mean
2809897|NCT00452426|Secondary|Duration of Deep Sedation/General Anesthesia|Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.|From first dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||minutes||Standard Deviation|Mean
2809898|NCT00452426|Primary|Area Under the Curve for Oxygen Desaturation (AUCDesat)|AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.|From administration of initial drug dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.|||seconds*percent of oxygen desaturation||95% Confidence Interval|Mean
2809900|NCT00452400|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set including all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
2809901|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2809902|NCT00452400|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2809903|NCT00452400|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=24 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2809904|NCT00452400|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=6 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2809905|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2809906|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2809907|NCT00452400|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2809908|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2809909|NCT00452400|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol (albuterol))|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Number of puffs||Standard Error|Least Squares Mean
2809910|NCT00452400|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
2809911|NCT00452400|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|Baseline PEFR was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter/minute||Standard Error|Least Squares Mean
2809912|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809913|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2812349|NCT00435162|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2809914|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809915|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|baseline and day1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809916|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809917|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 1 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809918|NCT00452400|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.Means are adjusted using a mixed effects model with baseline,treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809919|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809920|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809921|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours postdose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809922|NCT00452400|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Peak (0-3h) will be the maximum post-dose value during the first 3 hours. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2810474|NCT00447902|Primary|Treatment Response at Week 48|Treatment response is a confirmed virologic response, defined as a viral load less than 50 copies/mL at two consecutive measurements at least 5 days apart, without death, permanent discontinuation, or introduction of a new antiretroviral|48 weeks|The trial has been stopped due to a poor enrollment||||||
2809923|NCT00452400|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809924|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809925|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809926|NCT00452400|Secondary|Trough FVC Response After 4 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809927|NCT00452400|Secondary|Trough FVC Response After 2 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809928|NCT00452400|Secondary|Trough FVC Response After 1 Week|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809929|NCT00452400|Secondary|Trough FEV1 Response After 2 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809930|NCT00452400|Secondary|Trough FEV1 Response After 1 Week|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809931|NCT00452400|Primary|Trough FEV1 Response After 4 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.|||Liter||Standard Error|Least Squares Mean
2809932|NCT00452387|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death.||||Months||95% Confidence Interval|Median
2809952|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809933|NCT00452387|Secondary|Quality of Life (QoL)|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5.|The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.||||units on a scale||Full Range|Mean
2809934|NCT00452387|Secondary|Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging|The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher's exact test was used to test this hypothesis.|PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.||||Participants|||Number
2809935|NCT00452387|Primary|Median Time to Progression (TTP) by Imaging|Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.|Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.|Survival analysis was performed for 22 patients. However, the upper 95% confidence interval for median TTP could not be calculated and so the number of patients analyzed and the upper 95% confidence interval for median TTP could not be entered into the system.|||Months||95% Confidence Interval|Median
2809936|NCT00452374|Secondary|Number of Participants With a Complete Response or Partial Response|According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days||||Participants|||Number
2809937|NCT00452374|Primary|Maximum Tolerated Dose (MTD) Oxaliplatin|MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale.|From treatment onset to end of each cycle of treatment (every 21 days)|Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis.|||mg/m^2|||Number
2809938|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809939|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52||Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809940|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24||Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809941|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809942|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52||Weeks 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809943|NCT00452361|Secondary|Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104||Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809944|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809945|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809946|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809947|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809948|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809949|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809950|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809951|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809953|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809954|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809955|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.||||||
2809956|NCT00452361|Primary|Change in Glomerular Filtration Rate (GFR) Change From Baseline|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|104 weeks|No patients completed 104 weeks and therefore no data were available for efficacy analysis.||||||
2809957|NCT00452348|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a >=20% decrease in AM PEF, a >=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population|||attacks per participant per year||95% Confidence Interval|Mean
2809958|NCT00452348|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided|||Percentage of symptom-free days||Standard Error|Mean
2809959|NCT00452348|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values|||Liters/minute (L/min)||Standard Error|Mean
2809960|NCT00452348|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug who had at least one on-treatment FEV1|||Liters||Standard Error|Mean
2809961|NCT00452335|Secondary|Treatment Effectiveness|Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809962|NCT00452335|Secondary|Constipation Severity|Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809963|NCT00452335|Secondary|Pain Associated With SBMs|Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809964|NCT00452335|Secondary|Abdominal Discomfort|Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809965|NCT00452335|Secondary|Abdominal Bloating|Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809966|NCT00452335|Secondary|Stool Consistency of SBMs|Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809967|NCT00452335|Secondary|Straining Associated With SBMs|Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.|Weekly, up to 4 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
2809968|NCT00452335|Secondary|Frequency of Fecal Incontinence|As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.|Weekly, up to 4 weeks|ITT Population|||episodes of fecal incontinence per day||Standard Deviation|Mean
2809969|NCT00452335|Secondary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Weeks 2, 3, and 4|ITT Population|||spontaneous bowel movements per week||Standard Deviation|Mean
2809971|NCT00452114|Secondary|Quality of Life (Cough-Specific Quality of Life Questionnaire)|"Quality of life is measured using the Cough Specific Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life. The Cough-Specific Quality of Life Questionnaire consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life.~CQLQ scale ranges from 28 to 112 with higher scores indicating worse outcome or status."|12 months||||Scores on a scale||Standard Deviation|Mean
2809972|NCT00452114|Secondary|Quality of Life (St. George's Respiratory Questionnaire)|Quality of life is measured using St. George's Respiratory Questionnaire, a 50 item disease-specific instrument designed to measure impact on overall health, daily life and perceived well-being in patients with obstructive airways disease. The instrument consists of 2 parts, and 3 components. Part 1 measures symptom frequency and severity with a 1,3 or 12 month recall. Part 1 is evaluated using several scales. Part 2 measures impact of breathlessness on activities including social functioning and psychological disturbances. Part 2 is evaluated by dichotomous (true false) evaluation except the final question which is a 4 point likert scale. Scores range from 0 to 100 with higher score indicating more limitation and lower quality of life.|12 months|Outcomes not analyzed|||scores on a scale||Standard Deviation|Mean
2809973|NCT00452114|Primary|Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits|The impact of the intervention is measured by the number of hospitalizations and urgent/unscheduled outpatient visits the participants experienced within a 12 month period.|12 months||||Number of Hospitalizations/Visits||Standard Deviation|Mean
2809974|NCT00452114|Primary|Number of Suppurative Exacerbations Per Patient Per Year|The impact of the intervention is measured by the total number of suppurative exacerbations per patient within a 12 month period.|12 months||||Number of events per patient||Standard Deviation|Mean
2809975|NCT00451958|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||International units/Liter (IU/L)||Full Range|Median
2809976|NCT00451958|Secondary|Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||International units/Liter (IU/L)||Full Range|Median
2809977|NCT00451958|Secondary|Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||ng/mL||Full Range|Median
2809978|NCT00451958|Secondary|Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.|||ng/mL||Full Range|Median
2809979|NCT00451958|Secondary|Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards|"The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.~In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study."|Until all participants have received at least 5 years of treatment and at a frequency of every 6 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).|||percentage||95% Confidence Interval|Number
2809980|NCT00451958|Secondary|Percentage of Participants With no Prostate-specific Antigen (PSA) Progression|PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).|Until all participants have received at least 5 years of treatment and at a frequency of every 3 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).|||percentage of participants||95% Confidence Interval|Number
2809981|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.|||participants|||Number
2809982|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.|||participants|||Number
2809983|NCT00451906|Secondary|Number of Participants With Central Nervous System Bleeding|The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.|Up to 3 years|The ITT population was used for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. n = number of participants available at the time of assessment who were included in the analysis.|||participants|||Number
2810199|NCT00450112|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Week 9 to Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||milligrams||Standard Deviation|Mean
2809984|NCT00451906|Secondary|Time to Disease Progression|Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|Up to 3 years|The ITT population was considered for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.|||Months||95% Confidence Interval|Median
2809985|NCT00451906|Secondary|Duration of Overall Survival|Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.|||Months||95% Confidence Interval|Median
2809986|NCT00451906|Primary|Number of Participants With Serious Adverse Events Related to Bevacizumab|Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.|||participants|||Number
2809987|NCT00451906|Primary|Number of Participants With Adverse Events of Special Interest|Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.|||participants|||Number
2809988|NCT00451698|Secondary|Length of Hospitalization||At hospital discharge, up to 30 days|Analysis was limited to descriptive statistics due to low enrollment and study closure.|||days||Standard Deviation|Mean
2809989|NCT00451698|Secondary|Inotropic Support||24 and 48 hours post operative|These data were not collected||||||
2809990|NCT00451698|Primary|Echocardiographic Assessment of Heart Function||24 hours postop|These data were not collected.||||||
2809991|NCT00451698|Primary|Biochemical Markers of Neuron Damage||4 postoperative time points|There were 43 samples taken from the 9 subjects but no analysis was performed - the laboratory did not set up the assay to run the samples because the study did not have enough subjects to achieve statistical power.||||||
2809992|NCT00451698|Primary|Biochemical Markers of Heart Damage|Troponin I levels (ng/ml) measured at 4 time points|4 postoperative time points up to 48 hours|Analysis was limited to descriptive statistics due to low enrollment and study closure.|||ng/ml||Standard Deviation|Mean
2809993|NCT00451555|Secondary|Percentage of Participants With Enzastaurin Biomarkers and Disease State||Baseline, Cycle 2 to Study Completion (Up to 3 Years, 9 Months)|Zero participants were analyzed due to insufficient samples being collected.||||||
2809994|NCT00451555|Secondary|Number of Participants Who Discontinued With Adverse Events (AE) and Serious Adverse Events (SAEs)|Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. Participants who discontinued due to an AE or SAE are reported.|From Baseline to Study Completion (Up to 3 years, 9 months)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2809995|NCT00451555|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from baseline to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.|Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 3 Years)|All randomized participants who had received at least one dose of study drug and had evaluable PFS data. Participants were censored in Fulvestrant + Enzastaurin (QD) arm = 4, the Fulvestrant + Enzastaurin (BID) arm = 6, and the Fulvestrant + Placebo arm = 6.|||months||95% Confidence Interval|Median
2809996|NCT00451555|Secondary|Duration of Clinical Benefit|The duration of clinical benefit was measured from the time of clinical benefit of CR, PR or SD to the time of progressive disease or death from any cause. PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints.|Time of Clinical Benefit to Progressive Disease or Death (Up to 3 Years)|All randomized participants who received at least one dose of study drug and had evaluable clinical benefit duration data.|||months||95% Confidence Interval|Median
2809997|NCT00451555|Secondary|Percentage of Participants Achieving Overall Tumor Response Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR])|The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; SD was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. The 95% confidence interval (CI) was calculated by exact method. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints.|Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)|All randomized participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2809998|NCT00451555|Primary|Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate)|Clinical benefit rate is defined as the rate of confirmed CR, confirmed PR, and SD for 24 weeks duration and is the best response CR, PR, or SD as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.|Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)|All randomized participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2809999|NCT00451451|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution|2 years|The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.|||Proportion of Participants|||Number
2810000|NCT00451451|Secondary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Proportion of subjects,confirmed relapse|||Number
2810001|NCT00451451|Secondary|Number of New T1 Hypointense Lesions|The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption|||Number of lesions||95% Confidence Interval|Mean
2810002|NCT00451451|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.|||Number of lesions||95% Confidence Interval|Mean
2810003|NCT00451451|Primary|Annualized Relapse Rate|"A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.~The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment."|2 years|The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Relapses Per Year||95% Confidence Interval|Mean
2810004|NCT00451321|Secondary|Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)|Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value.|Baseline and up to Month 48|PD summary Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Data for only quantifiable concentration is presented.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
2810022|NCT00451321|Primary|Number of Participants With Cytokine Release AE|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose.|Up to Month 24|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2812350|NCT00435162|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2810005|NCT00451321|Secondary|Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days|Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration.|Up to Day 8|All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2810006|NCT00451321|Secondary|Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response|Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.|||Participants|||Count of Participants
2810007|NCT00451321|Secondary|CD3/TCR Complexes on CD4+ and CD8+ T Cells|Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|PD summary Population. Data was not collected for this endpoint.||||||
2810008|NCT00451321|Secondary|Saturation of CD4+ and CD8+ T Cells With Otelixizumab|Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|PD summary Population. Data was not collected for this endpoint.||||||
2810009|NCT00451321|Secondary|Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells|Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.|PD summary Population. Data was not collected for this endpoint.||||||
2810010|NCT00451321|Secondary|Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.|Day 8 and 28|PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Percentage of lymphocytes||Standard Deviation|Mean
2810011|NCT00451321|Secondary|Mean CD4+/CD8+ Ratio|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.|Day 8 and 28|PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Ratio||Standard Deviation|Mean
2810012|NCT00451321|Secondary|Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.|Day 8 and 28|PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Cells per microliter||Standard Deviation|Mean
2810013|NCT00451321|Secondary|Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count|One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The 'Pharmacodynamic (PD) summary population' was defined as participants in the 'All Subjects' Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol.|Day 8 and 28|Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.|||Cells per microliter||Standard Deviation|Mean
2810032|NCT00451217|Secondary|Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation|After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness|Day 1|All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement.|||Participants|||Count of Participants
2810014|NCT00451321|Secondary|Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab|PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.|At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.|PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.|||hour||Full Range|Median
2810015|NCT00451321|Secondary|Maximum Plasma Drug Concentration (Cmax) of Otelixizumab|PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.|At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.|PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2810016|NCT00451321|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab|Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The 'PK summary Population' was defined as participants in the 'All Subjects' Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed.|At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.|PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2810017|NCT00451321|Primary|Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load|EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented.|Up to Month 18|All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2810018|NCT00451321|Primary|Mean Overall Maximum Cytokines Level|Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)-alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample.|Up to Week 8|All subjects Population. Only those participants available for analysis for the particular parameter are presented. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
2810019|NCT00451321|Primary|Number of Participants With Abnormal Urinalysis Dipstick Results|Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as 'positive', and abnormal urine protein values were presented as 30 and 100 mg/dL.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2810020|NCT00451321|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCC|Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2810021|NCT00451321|Primary|Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)|Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.|Up to Month 48|All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2810050|NCT00450983|Secondary|Reconstitution of NK Function According to Time After HSCT||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
2810023|NCT00451321|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Month 24|The ‘All Subjects population’ was defined as all participants who received at least one dose of study medication and was used in all study population and safety analyses. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.|||Participants|||Count of Participants
2810024|NCT00451282|Secondary|Health Service Utilization Over the 6 Months Post-injury|Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.|6 months|||||||
2810025|NCT00451282|Secondary|Adherence With Medical Discharge Instructions|The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.|6 months|||||||
2810026|NCT00451282|Secondary|Health-related Quality of Life 6 Weeks and 6 Months Post-injury|The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.|6 months|||||||
2810027|NCT00451282|Secondary|Depression Symptoms in Children 6 Mos Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 week follow-up.|||Units on a scale||Standard Deviation|Mean
2810028|NCT00451282|Secondary|Depression Symptoms in Children 6 Wks Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.|||Units on a scale||Standard Deviation|Mean
2810029|NCT00451282|Primary|PTSD Symptoms in Children 6 Months Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 month follow-up.|||Units on a scale||Standard Deviation|Mean
2810030|NCT00451282|Primary|PTSD Symptoms in Children 6 Weeks Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.|||Units on a scale||Standard Deviation|Mean
2810031|NCT00451217|Secondary|Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room|Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness|Day 1|All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. One participant from the Rocuronium + Sugammadex treatment group, and one participant from the Vecuronium + Neostigmine treatment group were not analyzed.|||Participants|||Count of Participants
2810033|NCT00451217|Secondary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8|All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||Minutes||Standard Deviation|Mean
2810034|NCT00451217|Secondary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7|All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||Minutes||Standard Deviation|Mean
2810035|NCT00451217|Primary|Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9|All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||Minutes||Standard Deviation|Mean
2810036|NCT00451204|Other Pre-specified|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|12 months||||relapses per year||95% Confidence Interval|Mean
2810037|NCT00451204|Other Pre-specified|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|12 months||||relapses per year||95% Confidence Interval|Mean
2810038|NCT00451204|Secondary|Relapse Event, Probability of First Relapse Event||24 months|Included all as intention to treat|||probability of relapse event at 24 mo||95% Confidence Interval|Mean
2810039|NCT00451204|Secondary|Confirmed Relapse, Probability of First Relapse||24 months|All included as intention to treat|||probability of relapse at 24 months||95% Confidence Interval|Mean
2810040|NCT00451204|Secondary|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|24 months|Included all as intention to treat.|||relapses per year||95% Confidence Interval|Mean
2810041|NCT00451204|Primary|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|24 months|Included all as intention to treat|||relapses per year||95% Confidence Interval|Mean
2810042|NCT00451191|Primary|Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.|The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) >=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.|12 weeks|By the last 12-month follow-up visit, 15 men (22%) in the 100 U dose arm and 11 (17%) in the 300 U dose arm had withdrawn due to dissatisfaction with treatment results or continued to attend study follow-up but received additional alternate treatment prior to 12 months.|||participants|||Number
2810043|NCT00451048|Secondary|Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0)||Up to 6 years||||highest grade of adverse event reported|||Number
2810044|NCT00451048|Secondary|Time to Progression||At 6 months and 1 year|Date were not collected||||||
2810045|NCT00451048|Secondary|Progression-free Survival||At 6 months and 1 year|Data were not collected||||||
2810046|NCT00451048|Secondary|Overall Survival||At 6 months and 1 year||||months||95% Confidence Interval|Median
2810047|NCT00451048|Secondary|Number Participants With Complete, Partial or Hematologic Improvement Response|Assessed by achievement of Complete Response (CR), Partial Response (PR) or Hematologic Improvement (HI)|Up to 6 years|No patient achieved CR, PR or HI as response.|||participants|||Number
2810048|NCT00451048|Primary|Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria||Up to 6 years||||percentage of participants|||Number
2810049|NCT00450983|Secondary|Expression of NKG2 Ligands of Leukemic Blasts||Up to 5 years|Analysis for this endpoint not feasible due to funding constraint.||||||
2810059|NCT00450866|Secondary|Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat|||participants|||Number
2810060|NCT00450866|Secondary|CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat|||participants|||Number
2810061|NCT00450866|Secondary|Toxicity as Measured by NCI CTCAE v3.0|Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug - to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|3 months after treatment|Intention to treat|||percentage of participants|||Number
2810062|NCT00450866|Primary|Central Nervous System (CNS) Progression-free Survival(PFS)|"The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.~PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death."|3 months after treatment|Intention to treat|||participants|||Number
2810063|NCT00450814|Other Pre-specified|Viral Shedding|Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).|Up to 6 weeks|||||||
2810064|NCT00450814|Other Pre-specified|Viral Replication|Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).|Up to 6 weeks|||||||
2810065|NCT00450814|Other Pre-specified|Radiation Dose|The radiation dose that could be delivered to the bone marrow as well as critical organs such as the liver, lungs and kidneys if iodine-131 were to be administered using MIRDOSE 3 program will be estimated. Where patterns of correlation are indicated, ordinary and partial correlation coefficients (controlling for dose levels) will be calculated. Inferential testing for significant shifts in the correlative laboratory data results across dose levels will be carried out only as a hypothesis generating exercise.|Up to 6 weeks|||||||
2810066|NCT00450814|Other Pre-specified|NIS Gene Expression in Vivo|Will be correlated with tumor distribution. Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).|Up to 6 weeks|||||||
2810067|NCT00450814|Other Pre-specified|Biodistribution and Kinetics of Virus Spread|Will be correlated with tumor distribution. Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations between the laboratory values and other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).|Up to 6 weeks|||||||
2810068|NCT00450814|Other Pre-specified|Time Until Treatment Related Grade 3+ Toxicity (Phase I)|Tolerability will be explored in an ancillary manner through time-related variables, including time until treatment related grade 3+ toxicity. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using log-rank testing involving one covariate at a time.|Up to 1 year|||||||
2810069|NCT00450814|Other Pre-specified|Time Until Hematologic Nadirs (White Blood Cells, ANC, Platelets) (Phase I)|Tolerability will be explored in an ancillary manner through time-related variables, including time until hematologic nadirs. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using log-rank testing involving one covariate at a time.|Up to 1 year|||||||
2810070|NCT00450814|Other Pre-specified|Time Until Any Treatment Related Toxicity (Phase I)|Tolerability will be explored in an ancillary manner through time-related variables, including time until any treatment related toxicity. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using log-rank testing involving one covariate at a time.|Up to 1 year|||||||
2810071|NCT00450814|Secondary|Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II)|The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below for Phase II patients.|Up to 1 year|Only phase II patients who completed the study are included in this analysis. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B and to obtain the overall toxicity rate among Phase II patients.|||percentage of patients|||Number
2810072|NCT00450814|Secondary|Failure-free Survival (Phase II)|Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year. The distribution of failure-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year|Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.|||months||95% Confidence Interval|Median
2810117|NCT00450580|Secondary|Steady-state Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 4, 12, and 24|Blood samples were drawn at Weeks 4, 12, and 24 to determine plasma concentrations (Ctau) of APV and RTV|Weeks 4, 12, and 24|PK parameter (Ctau) Population – Participants in the ITT-E population who underwent PK sampling and had evaluable APV Ctau or RTV Ctau data|||micrograms/mL||95% Confidence Interval|Geometric Mean
2820647|NCT00379808|Secondary|High Density Lipoprotein (HDL)-Cholesterol|Lipid levels were determined at a clinical laboratory (Quest Diagnostics)|1 month|those completing entire study|||mg/dl||Inter-Quartile Range|Median
2810073|NCT00450814|Secondary|Progression-free Survival (Phase II)|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 5 years|Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating in Cohort B early and to get the overall PFS for Phase II patients.|||months||95% Confidence Interval|Median
2810074|NCT00450814|Secondary|Progression-free Survival (Phase II)|2-year progression-free survival (PFS2). Evidence of local recurrence, distant metastasis, or death from any cause within 2 years counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|At 2 years|Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.|||percentage of patients|||Number
2810075|NCT00450814|Secondary|Progression-free Survival (Phase II)|1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|At 1 year|Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.|||percentage of patients|||Number
2810076|NCT00450814|Secondary|Time to Progression (TTP) (Phase II)|Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year|Phase II specified secondary endpoint will only include Phase II patients. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating in Cohort B early and to get the overall TTP for Phase II patients.|||months||95% Confidence Interval|Median
2810077|NCT00450814|Secondary|Overall Survival (Phase II)|Time from registration to death due to any cause, assessed up to 1 year. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 1 year|Only phase II patients who completed the study are included in this analysis. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.|||months||95% Confidence Interval|Median
2810078|NCT00450814|Secondary|Number of Patients With Clinical Responses (Phase I)|The number of patients with clinical responses (CR, VGPR, PR, or minimal response [MR]) will be summarized by stage.|Up to 1 year|Per protocol, Phase I specified secondary endpoint is evaluated for each STAGE independently; thus, the stage 1 dose level groups were combined and the stage 2 dose level groups were combined for this analysis PER PROTOCOL.|||Participants|||Count of Participants
2810079|NCT00450814|Secondary|Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I)|The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.|Up to 1 year|Per protocol, Phase I specified secondary endpoint is evaluated for each STAGE independently; thus, the stage 1 dose level groups were combined and the stage 2 dose level groups were combined for this analysis PER PROTOCOL.|||percentage of patients|||Number
2810080|NCT00450814|Primary|Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better (Phase II)|Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 1 year|Only phase II patients who completed the study are included in this analysis. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.|||proportion of patients|||Number
2810081|NCT00450814|Primary|Maximum Tolerated Dose (MTD) (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The MTD is reported below.|6 weeks|Only phase I stage 1 patients who completed the study are included in this analysis. Dose levels 1-6 of Phase I Stage 1 patients were combined in this analysis to determine the MTD as defined above.|||Dose Level|||Number
2810082|NCT00450814|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.|6 weeks|Only phase I patients who completed the study are included in this analysis.|||Participants|||Count of Participants
2810083|NCT00450801|Secondary|Number of Patients Experiencing Adverse Events.|Number of patients experiencing adverse events during the course of protocol therapy.|Up to 5 years||||participants|||Number
2810084|NCT00450801|Secondary|Response Rate|Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement.|Up to 5 years|Participants who completed at least two cycles of therapy.|||percentage of participants||95% Confidence Interval|Number
2810085|NCT00450801|Secondary|Overall Survival Rate|Percentage of participants who are alive up to five years after receipt of protocol therapy.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2810086|NCT00450801|Primary|Progression-free Survival Rate|Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2810087|NCT00450749|Secondary|Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum||Baseline and at 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810088|NCT00450749|Secondary|Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue||At 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810089|NCT00450749|Secondary|Histological Characteristics of Prostatic Surgical Tissue||At 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810090|NCT00450749|Secondary|Expression of GST-pi in Prostatic Surgical Tissue||At 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810091|NCT00450749|Secondary|Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay||At baseline and at 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810092|NCT00450749|Secondary|Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3||At baseline and at 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810093|NCT00450749|Secondary|Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue||At 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810094|NCT00450749|Secondary|Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2||Baseline and at 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810095|NCT00450749|Secondary|Ratio of T:DHT in Prostatic Surgical Tissue||At 4-7 weeks|Because the trial closed before the accrual goals were met, therefore only the primary measures were analyzed. No secondary analyses were done.||||||
2810096|NCT00450749|Primary|Serum Levels (ug/dL) of Total Lycopene at Baseline and During Treatment by Group|Serum levels (ug/dL) of total lycopene at baseline and during treatment by group were measured.|Baseline and weeks 4 and 7|10 participants were analyzed at Baseline versus 8 at Week 4 and versus 5 at Week 7 due to drop out rate.|||ug/dL||Full Range|Median
2810097|NCT00450749|Primary|Concentration of Lycopene in Prostatic Surgical Tissue|Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.|At 4-7 weeks|Tissue samples collected from five participants for measurement of lycopene levels, representing only 50% (5 of 10) of the participants’ enrolled on-trial.|||ug/dL|||Number
2810098|NCT00450723|Primary|Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes||5 years|Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes.|||participants|||Number
2810099|NCT00450723|Primary|Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes||5 years||||participants|||Number
2810100|NCT00450723|Primary|Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy||5 years||||participants|||Number
2810101|NCT00450658|Secondary|The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.|The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic exam. Subjects were assigned according to the treatment to which they received.|||participants|||Number
2810102|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks||||participants|||Number
2810132|NCT00450450|Secondary|Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)|cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.|18 months post-transplant|Included only patients survived beyond 100 days.|||percentage of patients|||Number
2810103|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit were performed.|||participants|||Number
2810104|NCT00450658|Primary|Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.|The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination.|||participants|||Number
2810105|NCT00450619|Secondary|Palliation: Improvement in Baseline Pain|Subjective report of participant pain at baseline. This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|post quadramet (samarium)||||participants|||Number
2810106|NCT00450619|Secondary|Palliation: Pain at Baseline|Subjective report of participant pain at baseline.This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|Baseline||||participants|||Number
2810107|NCT00450619|Secondary|Objective Response (Complete Response + Partial Response)|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD.|4 weeks|Not all participants was measureable by RECIST.|||participants|||Number
2810108|NCT00450619|Secondary|Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 & 0 for PT 2 CD4/CD8 IL2 & 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.|||Absolute # CD4 or CD8 producing cytokine|||Number
2810109|NCT00450619|Secondary|Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.|||Absolute # CD4 or CD8 producing cytokine|||Number
2810110|NCT00450619|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months.||||Months||95% Confidence Interval|Median
2810111|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥50%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months||||participants|||Number
2810112|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months||||participants|||Number
2810113|NCT00450619|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years, 5 months||||Participants|||Number
2810114|NCT00450619|Primary|Progression Free Survival (PFS)|PFS is defined as the time to progress or die after the start of the therapy.|4 months||||months||95% Confidence Interval|Median
2810115|NCT00450619|Primary|Number of Patients With Stable Disease at 4 Months.|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.|4.7 months||||participants|||Number
2810116|NCT00450580|Secondary|Study Endpoints for a Subset of Subjects Receiving Study Drug Beyond 48 Weeks|Adaptive two-stage design study up to 48 weeks. N=200, expanding to 728 if continuation criteria were achieved based on a 24-week interim analysis. The initial 200 participants would continue until the last subject of the expanded cohort reached 48 weeks and would constitute the subset. As continuation criteria were not achieved, the study did not proceed to the second stage, and full analysis was performed on the initial 200 participants only.|Up to 60 weeks|||||||
2810133|NCT00450450|Secondary|Estimated 100-day Transplant Related Mortality (TRM) Percentage|Death in a patient after transplant due to protocol treatment is defined as an TRM.|100 days|One patient is inevaluable and is excluded from analysis.|||percentage of patients|||Number
2810118|NCT00450580|Secondary|Number of Protocol-defined Virological Failures With Genotypic and Phenotypic Resistance Changes|A blood sample was drawn at the time of confirmation of virological failure, and mutations present in the virus were identified and compared to those found in the blood sample at baseline. New mutations were tabulated by drug class. RT, reverse transcriptase. Virological failure could occur anytime from Week 4 to Week 48.|Time to virologic failure; Week 4 up to Week 48|Participants in the ITT-E Population who met the definition of virological failure|||Participants|||Number
2810119|NCT00450580|Secondary|Change From Baseline in Non-HDL Cholesterol at Week 48|Blood samples were drawn to determine the non-HDL cholesterol levels at Week 48. The mean absolute change in non-HDL cholesterol was defined as the Week 48 levels minus levels at baseline.|Week 48|Safety Population: all participants who received at least one dose of study medication|||mmol/L (millimoles/Liter)||Standard Deviation|Mean
2810120|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline CD4+ Count, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at week 48 was determined (by analysis of blood draw) and categorised by baseline CD4+ count.|Week 48|ITT-E Population|||Participants|||Number
2810121|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline Viral Load, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined (by analysis of blood draw) and categorised by baseline viral load (BVL).|Week 48|ITT-E Population|||Participants|||Number
2810122|NCT00450580|Secondary|Percentage of Participants With HIV-1 RNA <50 and >=50 Copies/mL by Visit Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined by the TLOVR algorithm|Week 48|ITT-E Population|||Percentage of participants|||Number
2810123|NCT00450580|Primary|Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined by the Time to Loss Of Virologic Response (TLOVR) algorithm.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: All randomised participants who received at least one dose of study medication|||Percentage of participants|||Number
2810124|NCT00450463|Secondary|Percentage of Participants With Antigen Specific Immune Responses Against Prostatic Specific Antigen (PSA)|Antigen specific responses were evaluated using intracellular cytokine staining of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cells (evaluating cluster of Differentiation 107a (CD107a), INFg, Interleukin-2 (IL-2), and tumor necrosis factor (TNF) for CD4+ and CD8+ T-cells. Peripheral blood mononuclear cells were separated by Ficoll-Hypaque density gradient separation, washed three times, and preserved in 90% heat-inactivated human A and B blood-type antigens) AB serum and 10% Dimethyl sulfoxide (DMSO) in liquid nitrogen at a concentration of 1 × 10^7 cells/mL until assayed. Analysis of antigen-specific responses following therapy was assessed by intracellular cytokine staining following a period of in vitro stimulation with overlapping 15-mer peptide pools. A more complete description can be found at Heery CR et al, Cancer Immunol Res. 2015 Nov;3(11):1248-56.|3 months||||percentage of participants|||Number
2810125|NCT00450463|Secondary|Number of Participants With Prostatic Specific Antigen (PSA) Response|Complete response is PSA <0.2 confirmed by a second reading at least 4 weeks later. All patients with a PSA decline of >50% (confirmed by a second value at least 4 weeks after the first) and who have no other evidence of disease progression will be reported with both PSA decline only and PSA decline and stable disease on scans. A 25% increase in PSA over nadir is progressive disease with or without evidence of metastatic disease, and/or development of disease on scans or a second occurrence of rising PSA levels in the absence of clinical progression.|Median potential follow-up for all patients is 46.7 months|Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously.|||Participants|||Count of Participants
2810126|NCT00450463|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Median Potential Follow-up of 46.7 months||||Participants|||Count of Participants
2810127|NCT00450463|Primary|Time to Treatment Failure|Time to treatment failure is defined as a rising Prostatic Specific Antigen (PSA) (Bubley criteria, JCO 1999), development of metastatic disease, or removal from treatment due to excessive toxicity) compared to patients receiving flutamide alone. Normal PSA is 4.0 ng/mL or lower.|Median Potential Follow-up of 46.7 months|Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously. Thus the data on TTF presented is for progression on flutamide alone.|||Months||Full Range|Median
2810128|NCT00450450|Other Pre-specified|Infused Nucleated and CD34+ Cell Doses|Compared using the Wilcoxon rank-sum test.|Up to 10 years|Data are not collected for this study.||||||
2810129|NCT00450450|Other Pre-specified|Immune Reconstitution|Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.|Up to 1 year|Data are not collected for this study.||||||
2810130|NCT00450450|Secondary|Estimated Median Length of Initial Hospitalization|Estimated and compared between randomization arms using the Wilcoxon rank-sum test.|Up to 10 years|Data regarding length of Initial Hospitalization are not collected for this study according to Study Chair.||||||
2810131|NCT00450450|Secondary|Estimated Median Time to Neutrophil Engraftment|Median Time from transplant to neutrophil engraftment|Up to 10 years|One patient was inevaluable and excluded from the analysis.|||Days||95% Confidence Interval|Median
2810136|NCT00450450|Primary|Estimated Two-year Event-free Survival (EFS)|EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.|at 2 years|Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.|||Percentage of patients||95% Confidence Interval|Number
2810137|NCT00450437|Primary|Percentage of Seroresponders, Ages 19 to 55 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Number
2810138|NCT00450437|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years|Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).|Days 1 to 7|The analysis was performed on the safety set.|||Participants|||Number
2810139|NCT00450437|Secondary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years|Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).|28 days after vaccination|The analysis set was the per protocol (PP) population.|||Titers||95% Confidence Interval|Geometric Mean
2810140|NCT00450437|Secondary|Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years|"Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analyses set was performed on the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Number
2810141|NCT00450437|Secondary|Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years|"The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The Analysis set was the per protocol (PP) population.|||Percentage of Participants||95% Confidence Interval|Number
2810142|NCT00450437|Primary|Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years|"Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.~Note: severe adverse events: unable to perform normal daily activity"|6 days after vaccination|The analysis was performed on the safety set.|||Participants|||Number
2810143|NCT00450437|Primary|Percentage of Seroresponders, Ages 11 to 18 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.|||Percentage of participants||95% Confidence Interval|Number
2810144|NCT00450437|Primary|Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years|The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)|28 days after vaccination|The analysis was performed on the Per Protocol (PP) Population|||Titers||95% Confidence Interval|Geometric Mean
2810145|NCT00450424|Secondary|Patient Satisfaction With the Preparation to Make a Decision|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU).|at enrollment and 2 weeks after enrollment|||||||
2810146|NCT00450424|Secondary|Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Impact of demographic factors, disease/family history characteristics, family support, and cancer-related distress on satisfaction with and completeness of the informed consent process was measured|at enrollment and 2 weeks after enrollment|||||||
2810147|NCT00450424|Secondary|Differential Impact of CD-ROM on Satisfaction With MSI Test Decision, Difficulty Making Decision & Decisional Conflict; Attitude; General & Cancer-related Distress; Discussions With Family About MSI Test & Familial Colorectal Cancer Risk|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Differential impact of CD-ROM on satisfaction with MSI test decision, difficulty making decision & decisional conflict; attitude; general & cancer-related distress; discussions with family about MSI test & familial colorectal cancer risk were measured.|at enrollment and 2 weeks after enrollment|||||||
2810148|NCT00450424|Primary|Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing|"10-item true/false MSI knowledge survey developed by the oncologists on trial. (e.g., Microsatellite Instability is found in every person that has had cancer.; Microsatellite Instability may be caused by a permanent change in a gene that is inherited from a person's mother or father.). Participants can score anywhere from 0 (no questions answered correctly) to 10 (all questions answered correctly)."|2 weeks after enrollment||||units on a scale||Standard Deviation|Mean
2810149|NCT00450411|Secondary|Biochemical (PSA) Failure||From registration to 5 years||2020-08-31|08/2020||||
2810150|NCT00450411|Secondary|Distant Failure||From registration to 5 years||2020-08-31|08/2020||||
2810151|NCT00450411|Secondary|Local Tumor Progression||From registration to 5 years||2020-08-31|08/2020||||
2810152|NCT00450411|Secondary|Disease-specific Survival||From registration to 5 years||2020-08-31|08/2020||||
2810153|NCT00450411|Secondary|Disease-free Survival||From registration to 5 years||2020-08-31|08/2020||||
2810154|NCT00450411|Secondary|Overall Survival||From registration to 5 years||2020-08-31|08/2020||||
2810155|NCT00450411|Secondary|Number of Patients With Acute Treatment-related GI and GU Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, acute treatment-related adverse events will be evaluated within 270 days from the implant.|From date of implantation to 270 days|Eligible patients who received protocol treatment with at least 270 days of follow-up from the date of implantation|||Participants|||Count of Participants
2810156|NCT00450411|Primary|Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.|Between 271 days and 730 days from date of implantation|Eligible patients who received protocol treatment with at least 23 months follow-up from the date of implantation|||Participants|||Count of Participants
2810157|NCT00450385|Secondary|Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.|Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.|Baseline||||Participants|||Count of Participants
2810158|NCT00450385|Secondary|Overall Response Rate of Study Participants at the End of Protocol Therapy|Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.|Up to 8 cycles, about 24 weeks||||Participants|||Count of Participants
2810159|NCT00450385|Secondary|Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy|The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.|24 Months|The determination could not be made because the study required a minimum of 90 participants for biomarker analyses and derivation of survival prediction model(s). Due to actual participant accrual (57) being far below the minimum required, no data were collected on the ability of models and/or biomarkers to predict time to treatment failure.||||||
2810160|NCT00450385|Primary|Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy|The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy|2 Years|The comparison could not be made because the study required a minimum of 90 participants for initial gene expression analyses from which survival prediction model(s) would be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no gene expression or survival prediction data were collected.||||||
2810161|NCT00450385|Primary|Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy|The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g. immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.|24 Months|The study required a minimum of 90 participants for associated biomarker analyses. Due to actual participant accrual (57) being far below the minimum number of participants required, no biomarker data were collected.||||||
2810162|NCT00450385|Primary|Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.|The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.|30 months|The study required a minimum of 90 participants for gene expression analyses from which survival prediction model(s) could be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no data were collected on gene expression, and no survival prediction models were constructed.||||||
2810163|NCT00450372|Secondary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.|||months||95% Confidence Interval|Median
2810164|NCT00450372|Secondary|Median Overall Survival|Overall survival will be estimated using the product-limit method of Kaplan & Meier.|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.|||months||95% Confidence Interval|Median
2810165|NCT00450372|Primary|Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.|Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.|||participants|||Number
2810166|NCT00450333|Secondary|Change From Baseline in Hematocrits at 16 and 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and Weeks 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.||||||
2810167|NCT00450333|Secondary|Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|week 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.||||||
2810168|NCT00450333|Primary|Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and 24 weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.||||||
2810169|NCT00450294|Primary|Left Intraocular Pressure|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure||||mm Hg||Standard Error|Least Squares Mean
2810170|NCT00450294|Primary|Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure|The analysis was per protocol.|||mm Hg||Standard Error|Least Squares Mean
2810171|NCT00450255|Secondary|Impact of the VEGF Trap Therapy on Laboratory Correlates||Up to 5 years|Laboratory Correlate data were not collected.||||||
2810172|NCT00450255|Secondary|Number of Participants With Toxicities|The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for AE grading and reporting. Grade 3 and higher adverse events considered possibly, probably or definitely related to aflibercept are summarized.|Up to 5 years||||Participants|||Count of Participants
2810173|NCT00450255|Secondary|Overall Survival|Will be estimated by the Kaplan-Meier method.|From the initial date of treatment to the recorded date of death, assessed up to 5 years||||Months||95% Confidence Interval|Median
2810174|NCT00450255|Primary|4 Month Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months||||percentage of patients||95% Confidence Interval|Number
2810175|NCT00450255|Primary|Objective Response Rate (CR + PR)|"Using the RECIST v1.0 criteria for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR.,"|Start of treatment to disease progression/recurrence, up to 5 years||||percentage of participants||95% Confidence Interval|Number
2810176|NCT00450242|Secondary|Modified Gracely Pain Scale|The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.|||units on a scale|||Number
2810177|NCT00450242|Secondary|SF-12 Quality of Life Scores|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.|||units on a scale|||Number
2810178|NCT00450242|Primary|Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8|"Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The mean listed for each group is average week 8 score subtracted from the average baseline score."|baseline, week 8|three lidocaine subjects and one control subject failed to complete the study.|||units on a scale||Standard Deviation|Mean
2810179|NCT00450242|Primary|Number of Participants Who Report the Ability to Have Intercourse|Participants' response upon inquiry.|baseline, week 8|Three lidocaine subjects and one control subject failed to complete the study.|||participants|||Number
2810180|NCT00450216|Secondary|The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)|The secondary efficacy endpoint was the number of participants developing a NSAID-associated serious gastrointestinal complication at any time throughout 24 weeks of treatment. A NSAID-associated serious gastrointestinal complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or gastrointestinal bleeding.|24 weeks||||particpants|||Number
2810181|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with duodenal ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks||||participants|||Number
2810182|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with UGI (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks||||participants|||Number
2810183|NCT00450216|Primary|Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers|The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination. Participants were assigned according to the treatment to which they were randomized; 2:1 randomization, HZT-501:ibuprofen.|||participants|||Number
2810184|NCT00450190|Secondary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.|Day 1 up to Day 90|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
2810185|NCT00450190|Secondary|Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit|Nurse/physician's feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician's response for the number of subjects were presented.|Inclusion visit (Day 1)|All included subjects were analyzed who used at least 1 dose of study medication with E-Device.|||subjects|||Number
2810186|NCT00450190|Secondary|Subjects' Feedback Immediately After Initial Training During Inclusion Visit|Subjects' feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented.|Inclusion visit (Day 1)|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
2810187|NCT00450190|Primary|Usefulness and Reliability of E-Device Functions|Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.|2 Weeks|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
2810188|NCT00450190|Primary|Subjects' Overall Impression After Using E-Device|Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.|2 Weeks|All subjects who were administered with at least 1 dose of study medication with E-Device.|||subjects|||Number
2810189|NCT00450177|Secondary|Average Length of Stay in the Hospital||Throughout hospital stay up to 6 weeks||||days||Standard Deviation|Mean
2810190|NCT00450177|Secondary|Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital||Throughout hospital stay up to 6 weeks||||Participants|||Count of Participants
2810191|NCT00450177|Secondary|Average Number of Days That Subjects Were Taking Antibiotics||Throughout hospital stay up to 6 weeks||||days||Standard Deviation|Mean
2810192|NCT00450177|Secondary|Instance of Drug-related Constipation Throughout Hospital Admission||Throughout hospital stay up to 6 weeks||||Participants|||Count of Participants
2810193|NCT00450177|Secondary|Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission||Throughout hospital stay up to 6 weeks||||Participants|||Count of Participants
2810194|NCT00450177|Secondary|Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital||Throughout hospital stay up to 6 weeks||||Participants|||Count of Participants
2810195|NCT00450177|Primary|Erythrocyte Zinc Protoporphyrin Concentration||Day 7, Day 14, Day 21, Day 28||||micromol:mol heme||Standard Deviation|Mean
2810196|NCT00450177|Primary|Serum Ferritin Concentration||Day 7, Day 14, Day 21, Day 28||||ng/mL||Standard Deviation|Mean
2810197|NCT00450177|Primary|Serum Iron Concentration||Day 7, Day 14, Day 21, Day 28||||mcg/mL||Standard Deviation|Mean
2810198|NCT00450177|Primary|Hematocrit||Day 7, Day 14, Day 21, Day 28||||percentage of RBC in blood||Standard Deviation|Mean
2810200|NCT00450112|Secondary|Improvement From Baseline in Physician Global Evaluations|Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
2810201|NCT00450112|Secondary|Improvement From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
2810202|NCT00450112|Secondary|Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||Percentage of Participants|||Number
2810203|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Total Score)|Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
2810204|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Physical Function Subscore)|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
2810205|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Stiffness Subscore)|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
2810206|NCT00450112|Secondary|Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)|Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||millimeters||Standard Deviation|Mean
2810207|NCT00450112|Primary|Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200||13 weeks||||participants|||Number
2810208|NCT00450073|Secondary|Parathyroid Hormone, Serum C-telopeptide, Osteocalcin||12 weeks|||||||
2810209|NCT00450073|Primary|25-hydroxyvitamin D|This is a marker of vitamin D status|12 weeks||||ng/mL||Standard Deviation|Mean
2810210|NCT00449956|Secondary|Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks|Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the FAS.|||Percent Change||95% Confidence Interval|Least Squares Mean
2810211|NCT00449956|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks|Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 Weeks|Last observed value during the 8-week treatment period was used in the FAS.|||Percent Change||95% Confidence Interval|Least Squares Mean
2810212|NCT00449956|Primary|Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks|Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).|||mmHg||95% Confidence Interval|Least Squares Mean
2810213|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2810214|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2810215|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2810216|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2810505|NCT00447590|Secondary|Subject Excess Weight Loss Throughout the Study|Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60|||%EWL||Standard Deviation|Mean
2810217|NCT00449930|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance <85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.|||Percent||95% Confidence Interval|Least Squares Mean
2810218|NCT00449865|Primary|The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.|All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).|Change from baseline to 5 YEARS|Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).|||summed-ranks||95% Confidence Interval|Mean
2810219|NCT00449787|Secondary|Patient Satisfaction|"At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication. This outcome tabulates the number of affirmative responses."|48 hours after ER discharge||||participants|||Number
2810220|NCT00449787|Secondary|Headache-related Functional Disability|This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.|Baseline, two hours|Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.|||participants|||Number
2810221|NCT00449787|Primary|Numerical Rating Scale|"Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable.~Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief"|Baseline, two hours|After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis|||units on a scale||Standard Deviation|Mean
2810222|NCT00449748|Primary|Number of Participants With Objective Response|Efficacy reported as objective response. Objective response defined as change in serum tryptase level or bone marrow mast cell percentage.|Monthly for first 3 months, then every 3 months|Analysis was per protocol.|||Participants|||Number
2810223|NCT00449696|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Weeks 9 to 13 (5 weeks)|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||milligrams||Standard Deviation|Mean
2810224|NCT00449696|Secondary|Change From Baseline in Physician Global Evaluations|Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule.|||scores on a scale||Standard Deviation|Mean
2810225|NCT00449696|Secondary|Change From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
2810226|NCT00449696|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore|Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
2810227|NCT00449696|Secondary|Change From Baseline in Short Form - 36 (SF-36)|Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores||Standard Deviation|Mean
2810228|NCT00449696|Secondary|Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 6 to 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||Percentage|||Number
2820648|NCT00379808|Primary|High-sensitivity C-reactive Protein|measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)|1 month|based on patients who completed the entire study|||mg/dl||Inter-Quartile Range|Median
2810229|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Total Score|Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
2810230|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Physical Function Subscore|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
2810231|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Stiffness Subscore|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.|||scores on a scale||Standard Deviation|Mean
2810232|NCT00449670|Secondary|Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6|This group consists of the remaining subjects from the GSK1562902A Pooled Group who received a single dose of H5N1 vaccine at Month 12 or 36.|From Month 6 to Month 12|The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who were not boosted at Month 6 (Non-Boosted sub-cohort) and for whom data were available for the considered timepoint.|||Participants|||Count of Participants
2810233|NCT00449670|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the booster phase (from Month 6 to Month 12)|The analysis was performed on the Booster Total Vaccinated Cohort, including all vaccinated subjects who were boosted at Month 6 and for whom data were available for the considered timepoint.|||Participants|||Count of Participants
2810234|NCT00449670|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the primary phase (from Day 0 to Month 6)|The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom were available for the considered timepoint.|||Participants|||Count of Participants
2810235|NCT00449670|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the booster phase (from Month 6 to Month 12)|The analysis was performed on the Booster Total Vaccinated Cohort, including all vaccinated subjects who were boosted at Month 6 and for whom data were available for the considered timepoint.|||Participants|||Count of Participants
2810236|NCT00449670|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the primary phase (from Day 0 to Month 6)|The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available for the considered timepoint.|||Participants|||Count of Participants
2810237|NCT00449670|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-days (Days 0-6) post-booster vaccination period|The analysis was performed on the Booster Total Vaccinated Cohort, including all vaccinated subjects who were boosted at Month 6 and who had completed their symptom sheet for the considered timepoint. Considering subjects from H5N1 Adjuvanted Group only received one single booster dose, data are reported only for booster dose 1 for this group.|||Participants|||Count of Participants
2810238|NCT00449670|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-days (Days 0-6) post-booster vaccination period|The analysis was performed on the Booster Total Vaccinated Cohort, including all vaccinated subjects who were boosted at Month 6 and who had completed their symptom sheet for the considered timepoint. Considering subjects from H5N1 Adjuvanted Group only received one single booster dose, data are reported only for booster dose 1 for this group.|||Participants|||Count of Participants
2813309|NCT00429364|Secondary|Annual Rate of Change in Upper to Lower Segment Ratio||Up to 3 years following randomization.|All randomized participants whose upper to lower segment ratios were measured at baseline and at any of the follow-up visits.|||1/year||Standard Error|Least Squares Mean
2810239|NCT00449670|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall|The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who had completed their symptom sheet for the considered timepoint.|||Participants|||Count of Participants
2810240|NCT00449670|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall|The analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects who had completed their symptom sheet for the considered timepoint.|||Participants|||Count of Participants
2810241|NCT00449670|Secondary|Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6|The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.|At Month 6 and at Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||T-cells per million T-cells||Standard Deviation|Mean
2810242|NCT00449670|Secondary|Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6|The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.|At Month 6 and Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||T-cells per million T-cells||Standard Deviation|Mean
2810243|NCT00449670|Secondary|Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation|The analyzed cytokines were CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||T-cells per million T-cells||Standard Deviation|Mean
2810244|NCT00449670|Secondary|Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation|The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||T-cells per million T-cells||Standard Deviation|Mean
2810245|NCT00449670|Secondary|Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation|The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.|Within 21 days of each primary vaccine dose: at Day 21 and at Day 42|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||T-cells per million cells||Standard Deviation|Mean
2810246|NCT00449670|Secondary|Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation|The analyzed cytokines were CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ). The stimulating antigen used was A/Vietnam/1194/2004.|Within 21 days of each primary vaccine dose: at Day 21 and at Day 42|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||T-cells per million T-cells||Standard Deviation|Mean
2810247|NCT00449670|Secondary|Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 0, Day 21, Day 42, Month 6 and Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810909|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to reach the target of 5*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥5*10^cells/kg collected during apheresis.|||days||Full Range|Median
2810248|NCT00449670|Secondary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12)|The analysis was performed on the Booster ATP cohort for persistence, which included all evaluable subjects who received a booster dose at Month 6, who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810249|NCT00449670|Secondary|Number of Subjects Seroprotected Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810250|NCT00449670|Secondary|Number of Subjects Seroprotected Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Before primary vaccination at Day 0 and within 21 days following each primary vaccination dose at Day 21 and at Day 42.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2810251|NCT00449670|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 21, at Day 42, at Month 6 and at Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Fold change||95% Confidence Interval|Number
2810252|NCT00449670|Secondary|Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Fold change||95% Confidence Interval|Number
2810253|NCT00449670|Secondary|Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Fold change||95% Confidence Interval|Number
2810254|NCT00449670|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Fold change||95% Confidence Interval|Number
2810255|NCT00449670|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At day 21 and Day 42|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Number
2810256|NCT00449670|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6|Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.|At Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810814|NCT00445315|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554||Screening up to Day 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2810257|NCT00449670|Secondary|Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6|Seroconversion defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-booster antibody titer.|At Day 21, Day 42, Month 6 and Month 12 following primary vaccination|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810258|NCT00449670|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase|Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:56 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.|Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810259|NCT00449670|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease|Seroconversion was defined as: antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Within 21 days following 2-dose primary vaccination at Day 42|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2810260|NCT00449670|Secondary|Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase|Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810261|NCT00449670|Secondary|Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase|Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Following booster vaccination at Month 6 +21 days (M6+21D) and Month 6 +42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810262|NCT00449670|Secondary|Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease|Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Participants|||Count of Participants
2810263|NCT00449670|Secondary|Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease|Seroconversion was defined as: for initially seronegative subjects, antibody titer greater than or equal to ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 21 (D21) and at Day 42 (D42)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2810264|NCT00449670|Secondary|Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2810265|NCT00449670|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects who did not receive a booster dose at Month 6 (Non-Boosted sub-cohort), who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2810842|NCT00445263|Secondary|Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography||until the exit from the hospital and at d30.|||||||
2810266|NCT00449670|Secondary|Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2810267|NCT00449670|Secondary|Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28.|Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2810268|NCT00449670|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12)|The analysis was performed on the Booster ATP cohort for persistence, which included all evaluable subjects who received a booster dose at Month 6, who complied with the protocol during the entire study period and for whom immunogenicity data for the considered assay and timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2810269|NCT00449670|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D)|The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received a booster dose at Month 6 for whom immunogenicity data for the considered assay and timepoint were available.|||Titers||95% Confidence Interval|Geometric Mean
2810270|NCT00449670|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|Within 21 days following the first primary vaccination dose (Day 21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2810271|NCT00449670|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|Within 21 days following 2-dose primary vaccination (at Day 42)|Analysis was performed on subjects from H5N1 Adjuvanted Lot Groups, included in the ATP cohort for immunogenicity, for lot-to-lot consistency of the immune response elicited by four compositions of GSK Biological’s pandemic influenza candidate vaccine. Analysis was also performed on the subjects from the H5N1 unadjuvanted group|||Titers||95% Confidence Interval|Geometric Mean
2810272|NCT00449670|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|Before vaccination (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2810273|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 2)|The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 24, Week 72, and Week 120 (Stage 2)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Percentage of Participants|||Number
2810274|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 1)|The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 8, 24, and 104 (Stage 1)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Percentage of Participants|||Number
2810330|NCT00448916|Secondary|Seizure Frequency.|Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.|28 Days|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810275|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 72 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 72, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
2810276|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 24 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
2810277|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 24 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
2810278|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 8 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 8, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.|||Days||95% Confidence Interval|Median
2810279|NCT00449540|Secondary|Percentage of Participants Who Have Photophobia|Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment||||Percentage of participants|||Number
2810280|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms Phonophobia|Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment||||Percentage of Participants|||Number
2810281|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms of Nausea|Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|two hours post treatment||||percentage of participants|||Number
2810282|NCT00449540|Primary|Percentage of Participants Experiencing no Pain at Two Hours Post-treatment|Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.|Two hours|Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period|||percentage of participants|||Number
2810283|NCT00449176|Secondary|Responder Analysis 50% Improvement|"Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|Intent to Treat Analysis Set|||Percentage of participants|||Number
2810284|NCT00449176|Secondary|Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline and 12 week endpoint|Intent to Treat Analysis Set, LOCF imputation method. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2810285|NCT00449176|Secondary|Number of Participants With Treatment Discontinuation Due to Lack of Efficacy|The number of participants who discontinued due to lack of efficacy from baseline to endpoint|Baseline and 12 weeks|Intent to Treat Analysis Set|||participants|||Number
2810843|NCT00445263|Primary|Mortality, Myocardial Infarction and Revascularization in Emergency||d30||||participants|||Number
2810286|NCT00449176|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved)|Baseline and 12 week endpoint|Intent to Treat Analysis (ITT) set, Last Observation Carried Forward (LOCF) imputation method. The ITT analysis set included all randomized subjects who took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||percentage of participants|||Number
2810287|NCT00449176|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat population with LOCF imputation. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||hours||Standard Deviation|Mean
2810288|NCT00449176|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set, last observation carried forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2810289|NCT00449176|Primary|Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent To Treat (ITT) analysis set utilizing Last Observation Carried Forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. 7 patients (3 tapentadol ER, 3 oxycodone CR, 1 placebo) had no baseline pain scores therefore excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2810290|NCT00449163|Secondary|Rate of Toxicity in Study Participants|Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.|2 years||||percentage of participants|||Number
2810291|NCT00449163|Secondary|Median Progression-free Survival in Months|Median number of months subjects achieved progression-free survival|2 years||||months||95% Confidence Interval|Median
2810292|NCT00449163|Secondary|Response Rate (Complete Response and Partial Response)|Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0|2 years||||percentage of participants||95% Confidence Interval|Number
2810293|NCT00449163|Primary|Overall Survival up to 2 Years|Percentage of patients with overall survival times of up to 2 years|2 years||||percentage of participants||95% Confidence Interval|Number
2810294|NCT00449150|Secondary|Time Course of Quality of Life|"The time course of quality of life: assessed by the following disease specific quality of life:If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that? The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible."|Quality of life assessment in the following weeks: 4,12,26,30,38,46,52||||score on a scale||Standard Deviation|Mean
2810295|NCT00449150|Primary|International Prostate Symptoms Score (IPSS)|The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks|The Intent-to-treat (ITT) population included all participants for whom at least one post-baseline efficacy assessment was available; imputation per Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
2810296|NCT00449072|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|"Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs.~A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was a medically important event"|From Day 1 to 7 days following end of treatment (Day 360)|All randomized and treated participants, excluding those from GCP noncompliant sites.|||participants|||Number
2810297|NCT00449072|Secondary|24 Hour Cortisol/Creatinine Ratio|Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio.|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.|||μg/g Creatinine||Standard Deviation|Mean
2810298|NCT00449072|Secondary|24 Hour Urinary Free Cortisol Levels|Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours].|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.|||μg/24 hours||Standard Deviation|Mean
2810331|NCT00448916|Secondary|Number of Participants With Abnormalities in Creatine Kinase.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810299|NCT00449072|Secondary|Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.~The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study."|double-blind treatment period (Day 1 to Day 360)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||percentage of days||Standard Deviation|Mean
2810300|NCT00449072|Secondary|Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.~The percentage of participants who used the rescue medication during each of the study periods is reported."|Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||percentage of participants|||Number
2810301|NCT00449072|Secondary|Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the investigator using the following scale:~0 = no relief (symptoms unchanged or worse than before)~1 = slight relief (symptoms were present and only minimally improved)~2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)~3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)~4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||score on a scale||Standard Deviation|Mean
2810302|NCT00449072|Secondary|Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:~0 = no relief (symptoms unchanged or worse than before)~1 = slight relief (symptoms were present and only minimally improved)~2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)~3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)~4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.|||score on a scale||Standard Deviation|Mean
2810303|NCT00449072|Secondary|Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:~0 = symptom absent~1 = mild (present but not annoying to self)~2 = moderate (annoying to self but not interfering with sleep or daily living)~3 = severe (interfered with daily living and/or sleep)~Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with available nasal symptom scores: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with available nasal symptom scores, excluding those from GCP noncompliant sites.|||score on a scale||Standard Error|Least Squares Mean
2810304|NCT00449072|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:~0 = symptom absent~1 = mild (present but not annoying to self)~2 = moderate (annoying to self but not interfering with sleep or daily living)~3 = severe (interfered with daily living and/or sleep)~TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with scores available for TNSS: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with scores available for TNSS, excluding those from GCP noncompliant sites.|||score on a scale||Standard Error|Least Squares Mean
2810305|NCT00449072|Primary|Growth Velocity|"Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time.~Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing."|Day 1 to end of treatment (Day 360)|The modified intent-to-treat (mITT) population included all intent-to-treat participants who had at least 3 postrandomization visits with recorded height measurements during the double-blind treatment period, excluding those from Good Clinical Practice (GCP) noncompliant sites.|||cm/year||Standard Error|Least Squares Mean
2810306|NCT00449046|Secondary|Number of Participants With Rescue Medication-Free Nights and Days|Rescue free means without the use of other medication.|Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Participants|||Number
2810307|NCT00449046|Secondary|Number of Participants With Symptom-Free Nights and Days||Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Participants|||Number
2810329|NCT00448916|Secondary|Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810308|NCT00449046|Secondary|Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24|"Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Percent Change||Standard Deviation|Mean
2810309|NCT00449046|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24|"The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||L/min||Standard Deviation|Mean
2810310|NCT00449046|Secondary|Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24|Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||Percent Change||Standard Deviation|Mean
2810311|NCT00449046|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24|"PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.|||L/min||Standard Deviation|Mean
2810312|NCT00449046|Primary|Serious Adverse Events (SAEs) - On Therapy|"Number of participants considered by the investigator to be related to study medication.~Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)"|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication.|||Participants|||Number
2810313|NCT00449046|Primary|Most Frequent Adverse Events - On Therapy|Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication|||Participants|||Number
2810314|NCT00449033|Secondary|EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population|The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2810315|NCT00449033|Secondary|Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2810316|NCT00449033|Secondary|Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population|TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.|from randomization of the first patient to 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||months||95% Confidence Interval|Median
2810317|NCT00449033|Secondary|Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population|LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.|from randomization of the first patient to 38 months later or death whatever occurs first.|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2810318|NCT00449033|Secondary|Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population|The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.|from randomization of the first patient until 38 months|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2810319|NCT00449033|Secondary|Time to Response (TTR) in the ITT (Non-squamous) Population|TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed.|||days||95% Confidence Interval|Median
2810320|NCT00449033|Secondary|Duration of Stable Disease (SD) in the ITT (Non-squamous) Population|Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed.|||days||95% Confidence Interval|Median
2810321|NCT00449033|Secondary|Duration of Response in the ITT (Non-squamous) Population|Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed.|||days||95% Confidence Interval|Median
2810322|NCT00449033|Secondary|Disease Control (DC) in the ITT (Non-squamous) Population|DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Disease Control based on ITT (non-squamous) population.|||percentage of participants|||Number
2810323|NCT00449033|Secondary|Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population|Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Tumour Response based on ITT (non-squamous) population.|||percentage of participants|||Number
2810324|NCT00449033|Secondary|Time to Progression (TTP) in the ITT (Non-squamous) Population|TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day.|||days||95% Confidence Interval|Median
2810325|NCT00449033|Secondary|Progression-free Survival (PFS) in the ITT (Non-squamous) Population|PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day.|||days||95% Confidence Interval|Median
2810326|NCT00449033|Secondary|OS in the ITT (Squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed.|||days||95% Confidence Interval|Median
2810327|NCT00449033|Secondary|OS in the ITT (Both Squamous and Non-squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.|||days||95% Confidence Interval|Median
2810328|NCT00449033|Primary|Overall Survival (OS) in the ITT (Non-squamous) Population|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.|||days||95% Confidence Interval|Median
2810332|NCT00448916|Secondary|Number of Participants With Abnormalities in Endocrine Panel (Hormones).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810333|NCT00448916|Secondary|Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810334|NCT00448916|Secondary|Number of Participants With Hematotolgical Abnormalities.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810335|NCT00448916|Secondary|Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).|"Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated.~Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below."|Week 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810336|NCT00448916|Secondary|Height at Month 12/Early Termination.|Height was recorded in centimeters.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included.|||cm||Standard Deviation|Mean
2810337|NCT00448916|Secondary|Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.|Weight was recorded in kilograms and weight change from Baseline was reported.|Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.|||Kg||Standard Deviation|Mean
2810338|NCT00448916|Secondary|Derived Body Mass Index Data (BMI) at Month 12/Early Termination.|BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.|||Kg/m^2||Standard Deviation|Mean
2810339|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810340|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810341|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810342|NCT00448916|Secondary|Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810343|NCT00448916|Secondary|Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|"Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as abnormal and no abnormalities in the sites were reported as normal. Any change from the previous physical examination results were noted."|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810361|NCT00448682|Primary|Number of Patients Achieving Clinical Response|Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.|1 year|The study data has not been analyzed.||||||
2810344|NCT00448916|Primary|Number of Participants With Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.|||Participants|||Number
2810345|NCT00448864|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve|Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)|1, 2, 4, and 8 hours after end of study drug infusion|All participants who received at least 1 dose of study drug.|||mg*h/L||Standard Deviation|Mean
2810346|NCT00448864|Secondary|Number of Participants With Treatment-emergent Adverse Events|A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|up to 28 days post admission to ICU|All participants who received at least 1 dose of study drug.|||participants|||Number
2810347|NCT00448864|Secondary|Cumulative Chest Tube Drainage at 24 Hours Postoperatively|Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 24 hours post admission to ICU|All participants who received at least 1 dose of study drug.|||Milliliters||Standard Deviation|Mean
2810348|NCT00448864|Primary|Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively|Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 12 hours post admission to intensive care unit (ICU)|All participants who received at least 1 dose of study drug.|||Milliliters||Standard Deviation|Mean
2810349|NCT00448760|Secondary|Overall Survival||24 months||||months||95% Confidence Interval|Median
2810350|NCT00448760|Secondary|Median Progression-free Survival (PFS)||24 months||||months||95% Confidence Interval|Median
2810351|NCT00448760|Secondary|Clinical Response|"Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest:~Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values.~Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions."|8 - 16 weeks||||percentage of participants||90% Confidence Interval|Number
2810352|NCT00448760|Primary|Pathologic Complete Response|No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.|8 - 16 weeks||||percentage of participants||90% Confidence Interval|Number
2810353|NCT00448747|Secondary|Number of Participants With Drug Related Adverse Events (AEs)|Total number of participants with drug related AEs, following macimorelin administration of L-Arginine (ARG) - Growth Hormone Releasing Hormone (GHRH) administration.|14 days|Safety Population|||Participants|||Count of Participants
2810354|NCT00448747|Secondary|Classification and Regression Tree (CART) Analysis of Peak Growth Hormone (GH) Following Macimorelin Administration|"The CART Analysis for macimorelin estimated: a) a macimorelin cut-point that minimized the misclassification of AGHD patients and healthy control subjects; b) an optimal decision tree for macimorelin that incorporated age, sex and BMI.~Sensitivity (correct identification of AGHD cases) and specificity (correct identification of control subjects) for macimorelin was summarized for age, gender, BMI and estrogen status subgroups containing n > 10.~At least 8 of the 10 newly enrolled AGHD patients should have been correctly classified for a protocol pre-specified threshold of Peak GH concentration which was 8.5 (ng/ml).~Software CART Version 6.0 was used."|GH sampling: pre-dose and 30, 45, 60, 75, 90, 120, 150 min post-dose|PPS = per protocol set. Decision tree for sex abandoned. Following Amendment No. 4, no comparison with L-ARG + GHRH was performed.|||percentage of participants|||Number
2810355|NCT00448747|Secondary|Peak Insulin-Like Growth Factor (IGF)-1 Concentration Following Treatment|Descriptive summaries for IGF-1 and correlation with GH concentrations based on macimorelin treatment. Mean IGF-1 values taken pre- and post- macimorelin administration.|15 min. before macimorelin administration and at 150 min after macimorelin administration|Modified Intent-to-treat analysis set used for analysis of mean IGF-1 values taken pre- and post-macimorelin administration.|||ng/mL||Standard Deviation|Mean
2810356|NCT00448747|Primary|Receiver Operating Characteristic (ROC) Analysis on Peak GH (Growth Hormon) Concentrations|The primary endpoint for each individual is the peak GH concentration following AEZS-130 (macimorelin) administration.|GH sampling: pre-dose and 30, 45, 60, 75, 90, 120, 150 min post-dose|PPS = per protocol set: this was considered to be the most appropriate for determination of the diagnostic utility of macimorelin|||ng/mL||Standard Deviation|Mean
2810357|NCT00448708|Secondary|Adverse Events|adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.|1 year||||participants|||Number
2810358|NCT00448708|Primary|Time-to-loss of Target Site Primary Patency|"Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol."|1 year||||days||95% Confidence Interval|Median
2810359|NCT00448682|Secondary|Number of Participants Experiencing Adverse Events|Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.|1 year|The study data has not been analyzed.||||||
2810360|NCT00448682|Secondary|Overall Rate of Survival|Patients will be followed for overall survival from date of enrollment to date of death or last contact. The extent of follow up will be described by the range and median for deceased patients and for those alive at last follow up. We will estimate the 1 year survival rates by the Kaplan-Meier method.|1 year|The study data has not been analyzed.||||||
2810362|NCT00448669|Secondary|CD4 Evaluation After HIV Seroconversion|Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated.|1-year post seroconversion||||cells/microliter||95% Confidence Interval|Geometric Mean
2810363|NCT00448669|Secondary|Antiretroviral (ARV) Resistance Patterns in Seroconverters|Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations.|At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis||||Participants|||Count of Participants
2810364|NCT00448669|Secondary|Rates of Adherence to Study Medication|The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test.|36 months||||Percentage of pills taken||Standard Deviation|Mean
2810365|NCT00448669|Secondary|Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts|We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment.|12 months|Of 1219, 19 excluded (3 HIV-infected at enrollment, 16 never started drug). Of the 1200, 24 reported no sex during study. Remaining total 1176 with >=1 sex act included in analysis.|||Participants|||Count of Participants
2810366|NCT00448669|Primary|HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms|Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort).|Monthly, for up to 3 years|Of the 1219, 3 were excluded from analysis because HIV-infected at the time of enrollment.|||infections/100 person-years|||Number
2810367|NCT00448669|Primary|Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms|Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.|Monthly, for up to 3 years||||percentage of participants with AE|||Number
2810368|NCT00448630|Secondary|Metabolic Syndrome Parameter Triglycerides by Treatment Group|Iterative measurement of triglycerides. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
2810369|NCT00448630|Secondary|Metabolic Syndrome Parameter Waist Circumference by Treatment Group|Iterative measurement of waist circumference. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||cm (centimeter)||Standard Deviation|Mean
2810370|NCT00448630|Secondary|Metabolic Syndrome Parameter Weight by Treatment Group|Iterative measurement of weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg||Standard Deviation|Mean
2810371|NCT00448630|Primary|Metabolic Syndrome Parameter Triglycerides|Iterative measurement of triglycerides. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
2810372|NCT00448630|Primary|Metabolic Syndrome Parameter High Density Lipoprotein (HDL)|Iterative measurement of HDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
2810373|NCT00448630|Primary|Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)|Iterative measurement of LDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
2810374|NCT00448630|Primary|Metabolic Syndrome Parameter Total Cholesterol|Iterative measurement of total cholesterol. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl||Standard Deviation|Mean
2810375|NCT00448630|Primary|Metabolic Syndrome Parameter Fasting Blood Sugar|Iterative measurement of fasting blood sugar. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||mg/dl (miligrams per deciliter)||Standard Deviation|Mean
2810376|NCT00448630|Primary|Metabolic Syndrome Parameter Waist Circumference|Iterative measurement of waist circumference. Mean at timepoints.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||cm (centimeter)||Standard Deviation|Mean
2810377|NCT00448630|Primary|Metabolic Syndrome Parameter Body Weight|Iterative measurement of body weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg (kilogram)||Standard Deviation|Mean
2810378|NCT00448630|Secondary|Metabolic Syndrome Parameter BMI by Treatment Group|Iterative measurement of BMI. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg/m*m||Standard Deviation|Mean
2810379|NCT00448630|Primary|Metabolic Syndrome Parameter Body Mass Index (BMI)|Iterative mean Body Mass Index at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.|||kg/m*m (kilograms per meter squared)||Standard Deviation|Mean
2810844|NCT00445224|Primary|Visual Analog Pain Scale|Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain|8 week||||centimeters||Standard Deviation|Mean
2810380|NCT00448591|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)|Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion|Safety Population|||percentage of participants|||Number
2810381|NCT00448591|Secondary|Percentage of Participants by Best Overall Response to Treatment|Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||percentage of participants|||Number
2810382|NCT00448591|Secondary|Overall Survival|Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.|Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months|ITT Population|||months||Full Range|Median
2810383|NCT00448591|Secondary|Percentage of Participants With Recorded Death||Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||percentage of participants|||Number
2810384|NCT00448591|Secondary|Time to Progression (TTP)|TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||months||Full Range|Median
2810385|NCT00448591|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population|||percentage of participants|||Number
2810386|NCT00448539|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase|"Seizure data was collected via patient diaries. OL refers to open-label."|Baseline, Titration Phase (Days 1 to 18), Maintenance Phase|Intent-to-treat (ITT) population: All subjects who completed titration to open-label medication|||Percentage change||Full Range|Median
2810387|NCT00448448|Primary|Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)||Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.|The primary analysis included all patients who had completed the trial by January 2013, including 116 patients from the randomized arm and 126 from the preference arm.|||percentage of patient successes|||Number
2810388|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of participants|||Number
2810389|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of participants|||Number
2810390|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of circadian variation||Standard Deviation|Mean
2810391|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||L/Min||Standard Deviation|Mean
2810392|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of personal best value||Standard Deviation|Mean
2810393|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||Percentage of predicted value||Standard Deviation|Mean
2810500|NCT00447603|Primary|Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.||||||
2810394|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.|||L/min||Standard Deviation|Mean
2810395|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights and Days|Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment|Crossover Period Weeks 1-4, 7-10|PPS|||Percentage of participants|||Number
2810396|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days|Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment|Crossover Period Week 1-4, 7-10|PPS|||Percent of participants|||Number
2810397|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS|||Percentage of circadian variation||Standard Error|Mean
2810398|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS|||L/min||Standard Error|Mean
2810399|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS|||Percentage of personal best value||Standard Error|Mean
2810400|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS|||Percentage of predicted value||Standard Error|Mean
2810401|NCT00448435|Primary|Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).|Crossover Period Weeks 1-4, and 7-10|PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.|||Liters/minute||Standard Error|Mean
2810402|NCT00448357|Secondary|Overall Survival|Percentage of participants alive at 3 years post transplant|Three years post-transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.|||percentage of participants|||Number
2810403|NCT00448357|Secondary|Incidence of DNA Chimerism in Patients Between One Month Post Transplant|Deoxyribonucleic acid (DNA) chimerism is a measure identifying the genetic profiles of the transplant recipient and of the donor and then evaluating the extent of mixture in the recipient's blood, bone marrow, or other tissue.|30 days post transplant|Because there were no differences in chimerism results as a function of either the immunosuppression used or busulfan dose received, the results are being reported only for the total population.|||Participants|||Count of Participants
2810404|NCT00448357|Secondary|Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant|"GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces"|100 days post transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.|||Participants|||Count of Participants
2810405|NCT00448357|Secondary|Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen|Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error.|Day -15 to Day -11||||percentage of error|||Number
2810406|NCT00448357|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis.|first 6 weeks or 42 days following stem cell infusion||||DLTs|||Number
2810501|NCT00447590|Secondary|Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire|Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the IWQOL Kids questionnaire through month 60 (year 5).|||units on IWQOL Kids scale||95% Confidence Interval|Mean
2810407|NCT00448357|Primary|Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)|Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years|Three years post-transplant|Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.|||percentage of participants|||Number
2810408|NCT00448344|Secondary|The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up|self-reported 7- day point prevalent abstinence|12-months follow-up||||percentage of participants that quit|||Number
2810409|NCT00448344|Primary|The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention|self-reported 7-day point prevalent abstinence|5 months||||percentage of participants that quit|||Number
2810410|NCT00448279|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population|||percentage of participants||95% Confidence Interval|Number
2810411|NCT00448279|Secondary|Percentage of Participants by Best Overall Response (BOR)|BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population|||percentage of participants|||Number
2810412|NCT00448279|Secondary|Overall Survival - Time to Event|The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population|||months||95% Confidence Interval|Median
2810413|NCT00448279|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population|||percentage of participants|||Number
2810414|NCT00448279|Primary|Progression-Free Survival - Time to Event|The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.|BL and every 8 weeks thereafter|ITT population|||months||95% Confidence Interval|Median
2810415|NCT00448279|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.|Baseline (BL) and every 8 weeks thereafter|ITT population|||percentage of participants|||Number
2810416|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel|"Assessed by the study personnel using a 5-point scale after dosing:~Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation~Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose~Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose~Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose~Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.|||Participants|||Number
2810417|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-6h)|Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||(μg/mL)•h||Standard Deviation|Mean
2810418|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-tlast)|Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||(μg/mL)•h||Standard Deviation|Mean
2810419|NCT00448227|Primary|Pharmacokinetics of Single Dose - Cmax|Measured by Cmax - The maximum plasma concentration of study medication|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||μg/mL||Standard Deviation|Mean
2810845|NCT00445224|Secondary|Hip Abduction Strength|Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer|8 week||||(Newton*meters)/(Weight*Height)||Standard Deviation|Mean
2810846|NCT00445224|Secondary|Objective Function by Step-down Task for 30 Seconds||Baseline, Mid, and Post-Intervention|||||||
2810420|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver|"Assessed by the caregiver using a 5-point scale immediately after dosing:~Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation~Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose~Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose~Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose~Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.|||Participants|||Number
2810421|NCT00448227|Secondary|Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.|"Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:~Significant emesis occurred,~Infant spit out most of the dose ingesting less than half of what was administered,~Infant spit out some of the dose, but ingested at least 50% of what was administered,~Infant was able to ingest and retain the dose administered"|30 minutes after dosing|Safety population.|||Participants|||Number
2810422|NCT00448227|Secondary|Safety Assessed by Labs|Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.|2 days|||||||
2810423|NCT00448227|Secondary|Safety Assessed by AEs, SAEs|AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.|38 days|||||||
2810424|NCT00448227|Primary|Pharmacokinetics of Single Dose - Tmax|Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.|||hours||Full Range|Median
2810425|NCT00448201|Secondary|Graft-vs-host Disease at 6 Months Post-transplant|"Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces~Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled.~Extensive chronic GVHD - Usually occurs at about three months post-transplant."|6 Months||||percentage of participants|||Number
2810426|NCT00448201|Secondary|5-year Disease-free Survival|The length of time post-transplant that the patient survives without any signs or symptoms of that cancer.|Year 5||||percentage of participants|||Number
2810427|NCT00448201|Secondary|Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant|"Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC).~Chimerism was not tabulated on day 30."|Days 30, 60, and 90||||percentage of patients|||Number
2810428|NCT00448201|Secondary|Complete Response at 6 and 12 Months Post-transplant||6 and 12 months|Complete response was not calculated at 6 and 12 months because the majority of patients had complete response at the time of transplant.||||||
2810429|NCT00448201|Primary|Treatment-related Mortality|Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.|6 months||||percentage of participants|||Number
2810430|NCT00448175|Secondary|Known Side Effects Through 12 Weeks||12 weeks|||||||
2810431|NCT00448175|Secondary|OAB Quality of Life at 12 Weeks||12 weeks|||||||
2810432|NCT00448175|Secondary|Volume Voided at 12 Weeks||12 weeks|||||||
2810433|NCT00448175|Secondary|Urge Incontinence Episodes at 12 Weeks||12 weeks|||||||
2810434|NCT00448175|Primary|Frequency of Voids at 12 Weeks|To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.|Baseline to 12 weeks||||Voids/day||Standard Deviation|Mean
2810435|NCT00448136|Secondary|EORTC QLQ-C30 Functional and Symptom Scale Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2810445|NCT00448136|Secondary|Duration of OR - Time to Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2810847|NCT00445224|Secondary|Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent||Baseline, Mid and Post-Intervention|||||||
2810848|NCT00445224|Secondary|Strength by Isometric Dynamometer||Baseline, Mid, and Post-Intervention|||||||
2810436|NCT00448136|Secondary|Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2810437|NCT00448136|Secondary|Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2810438|NCT00448136|Secondary|OS - Percentage of Participants Surviving at 12 and 24 Months|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population.|||percentage of participants|||Number
2810439|NCT00448136|Secondary|OS - Time to Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population|||months||95% Confidence Interval|Median
2810440|NCT00448136|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
2810441|NCT00448136|Secondary|Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months|Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.|||percentage of participants|||Number
2810442|NCT00448136|Secondary|Duration of ODC - Time to Event|Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.|||months||95% Confidence Interval|Median
2810443|NCT00448136|Secondary|Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event|Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
2810444|NCT00448136|Secondary|Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months|Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
2810471|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit|Patients with a viral load of less than 400 copies/mL at each visit as measured from a plasma sample.|After 4 weeks of treatment until the end of the trial|||||||
2810849|NCT00445224|Primary|Subjective Function by Lower Extremity Functional Scale Report Form||Baseline, Mid-Intervention, and Post-Intervention|||||||
2810446|NCT00448136|Primary|PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
2810447|NCT00448136|Primary|PFS - Time to Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||months||95% Confidence Interval|Median
2810448|NCT00448136|Secondary|Duration of Overall Response (OR) - Percentage of Participants With an Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.|||percentage of participants|||Number
2810449|NCT00448136|Secondary|Percentage of Participants With a Response by Best Overall Response|Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population. Data were missing from centralized review for 1 participant.|||percentage of participants||95% Confidence Interval|Number
2810450|NCT00448136|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population|||percentage of participants|||Number
2810451|NCT00448123|Secondary|High Pain Score by Treatment Group|Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.|7 Days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.|||units on a scale||Full Range|Mean
2810452|NCT00448123|Secondary|Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge||1-7 days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.|||Pain tablets||Full Range|Mean
2810453|NCT00448123|Primary|Stone Passage|Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.|1-7 days|In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.|||participants|||Number
2810454|NCT00448019|Secondary|Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL|ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.|||percentage of participants|||Number
2810455|NCT00448019|Secondary|Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)|Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.|||participants|||Number
2810456|NCT00448019|Primary|Progression Free Survival (PFS) Rate|Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline up to 5 years|Five participants of the 62 treated participants were not evaluable for response.|||Months||Full Range|Median
2810457|NCT00447902|Primary|The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study.|Dose-limiting hepatotoxicity was defined as Grade 4 ALT or AST elevation confirmed in 48h or any evocative symptoms or signs of hepatitis, if it not clearly attributable to another cause. Patients who experienced dose-limiting hepatotoxicity stopped TPV/r and were considered treatment failures for the analysis.|From the start of the study through 48 weeks.|||||||
2810458|NCT00447902|Secondary|Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements|Frequency of patients (%) with possible clinically significant abnormalities of laboratory measurements (haematology, differentials (automatic and absolute), coagulation, electrolytes, enzymes, substrates, urinalysis, serology and T-cells)|Baseline through 48 weeks||||percentage of participants|||Number
2810459|NCT00447902|Secondary|Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4|Post-dose Tipranavir (TPV) and Ritonavir (RTV) plasma concentrations at Week 4|Week 4|The trial has been stopped due to a poor enrollment||||||
2810460|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Trough Concentration >120 μM|Patients with TPV trough above 120 μM are at high risk of developing a Grade 3 or 4 ALT or AST elevations. The risk of Grade 3 or greater transaminase elevations appeared to be uniform at TPV trough concentration below 120 μM. Hence, for this study the TPV trough should be maintained below 120 μM.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment||||||
2810461|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured|A high inhibitory quotient (IQ), the ratio of trough plasma drug concentration to the protein-adjusted viral IC50, is a useful indicator of the potential efficacy margin of antiretroviral drugs. The IQ for TPV is calculated by the formula IQ = TPV Ctrough / (3.75 x Z x fold change of the patients virus), where Z = wild type control IC50 IIIB.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment||||||
2810462|NCT00447902|Secondary|Patients Adherence With Study Medication Based on Pill Count|number of pills actually taken divided by the planned number of pills the patient should take|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
2810463|NCT00447902|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|Tipranavir (TPV) and Ritonavir (RTV) trough concentrations from plasma samples at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
2810464|NCT00447902|Secondary|Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.|Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
2810465|NCT00447902|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48|Change from baseline to Week 48 for the ratio of CD38+ to CD8+ cell counts. Samples were obtained for CD38+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
2810466|NCT00447902|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48|Change from baseline to Week 48 for CD4+ and CD8+ cell counts. Samples were obtained for CD4+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment||||||
2810467|NCT00447902|Secondary|Time to New AIDS or AIDS Related Progression Event or Death|Time to new AIDS or AIDS related progression event or death as defined by AIDS defining and/or AIDS-related illnesses.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
2810468|NCT00447902|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
2810469|NCT00447902|Secondary|Change in Viral Load From Baseline at Each Visit|Change in viral load (measured from a plasma sample) from baseline at each visitPatients with a viral load of less than 400 copies/mL at each visit as .|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment||||||
2810470|NCT00447902|Secondary|Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48|Occurrence of greater than or equal to 1 log10 drop in viral load from baseline at all visits, including visits at Weeks 24 and 48|Baseline, 24 and 48 weeks|The trial has been stopped due to a poor enrollment||||||
2810475|NCT00447876|Secondary|Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit|A global assessment of the patient's current condition relative to baseline was performed by the patient at each visit using a 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.|||Number of participants|||Number
2810476|NCT00447876|Secondary|Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit|A global assessment of the patient's current condition relative to baseline was performed by the Investigator at each visit using 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.|||Number of participants|||Number
2810477|NCT00447876|Secondary|Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18|Dorsal extension and plantar flexion of the affected foot were assessed at baseline and at Week 18. A ROM of approximately 70 degrees is considered to be normal. The LS means, adjusted for the baseline value are reported.|Baseline and Week 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable was only analyzed for 34 patients (18 for Dysport® and 16 for Placebo) for whom ROM was determined at both baseline and Week 18.|||Degrees||95% Confidence Interval|Least Squares Mean
2810478|NCT00447876|Secondary|Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study|Assessments of the pressure threshold using an algometer (which corresponded to the minimum pressure causing pain) were performed at each visit. Pressure threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pressure threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pressure threshold are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||(kg / cm^2) * day||95% Confidence Interval|Least Squares Mean
2810479|NCT00447876|Secondary|Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit|Pressure pain in the medial back foot was measured using an algometer. Pressure threshold corresponded to the minimum pressure causing pain. The changes from baseline, expressed as pressure threshold differences at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||kg / cm^2||Standard Deviation|Mean
2810480|NCT00447876|Secondary|Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study|Assessments of the pain threshold using an algometer (which was the pressure corresponding to the maximum tolerated pain) were performed at each visit. Pain threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pain threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pain threshold are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||(kg / cm^2) * day||95% Confidence Interval|Least Squares Mean
2810481|NCT00447876|Secondary|Changes From Baseline in Pain Threshold at Each Visit|The maximum pain felt in the medial back foot was measured using an algometer. The pain threshold corresponded to the maximum pressure at which pain was still tolerated. Changes from baseline, expressed as pain threshold differences at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||Kilogram (kg) / cm^2||Standard Deviation|Mean
2810482|NCT00447876|Secondary|Assessment of SPID for Continuous Pain for Overall Study|Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of PID as a function of time (i.e. SPID). The LS means for SPID, adjusted for the baseline value of pain at rest are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||cm * day||95% Confidence Interval|Least Squares Mean
2810483|NCT00447876|Secondary|Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit|Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as PID values at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||cm||Standard Deviation|Mean
2810502|NCT00447590|Secondary|Change in Quality of Life Using the Beck Depression Inventory II (BDI)|Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the BDI II questionnaire through month 60|||units on BDI scale||95% Confidence Interval|Mean
2810850|NCT00445224|Primary|Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)|0 to 10 cm line with 0 representing no pain and 10 representing severe pain|weekly||||centimeter||Standard Deviation|Mean
2810484|NCT00447876|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study|Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the area under the curve (AUC) of PID as a function of time (i.e. SPID). The least square (LS) means of SPID, adjusted for the baseline value of pain while moving are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||cm * day||95% Confidence Interval|Least Squares Mean
2810485|NCT00447876|Secondary|Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit|Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as Pain Intensity Difference (PID) values at each indicated timepoint are reported.|Baseline and Weeks 2, 6, 10, 14 and 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.|||Centimeter (cm)||Standard Deviation|Mean
2810486|NCT00447876|Secondary|Changes From Baseline in Gerbershagen's Score at Week 18|The Gerbershagen scale gives a global score ranging between I and III, with lower scores reflecting less impact of pain in terms of temporal, spatial aspects, drug taking behaviour and utilization of the health care system. The changes in Gerbershagen's global scores from baseline to Week 18 are reported as percentage of patients for each of the specified categories.|Baseline and Week 18|The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable could only be analyzed for 30 patients (15 from each group) for whom the score could be determined both at baseline and at Week 18.|||Percentage of participants|||Number
2810487|NCT00447876|Primary|Responders Rate at Week 6 (Pain While Moving)|The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.|Baseline and Week 6|The Intention-To-Treat (ITT) analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least once at a later timepoint. Missing values were replaced using the last observation carried forward (LOCF) method.|||Percentage of participants|||Number
2810488|NCT00447772|Secondary|Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)|"At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories:~= very good~= good~= moderate~= insufficient~The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented."|Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||Participants|||Number
2810489|NCT00447772|Secondary|Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)|"Global pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories:~= no pain (anymore)~= less pain~= no change~= more pain~The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented."|Week 4 visit and Week 12 visit|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||Participants|||Number
2810490|NCT00447772|Secondary|Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).~The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||percentage of patients|||Number
2810491|NCT00447772|Secondary|Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).~The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
2810503|NCT00447590|Secondary|Change in Subjects' Comorbid Conditions|The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved.|Baseline to 5 Years|Subjects who had a specific comorbid condition at baseline (Diabetes n=9, Dyslipidemia n=39, Hypertension n=22)|||participants whose condition resolved|||Number
2810851|NCT00445211|Secondary|Hospital Death During the Index Hospitalization||0-4 post surgery||||Participants|||Count of Participants
2810492|NCT00447772|Secondary|Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD.~This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL).~The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
2810493|NCT00447772|Secondary|Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0-3 points)~Subscore D: severity and duration of tremor (range: 0-4 points).~A higher score for each subscale represents severe CD symptoms. The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
2810494|NCT00447772|Secondary|Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0-3 points)~Subscore D: severity and duration of tremor (range: 0-4 points).~The total score was calculated as follows: total score = subscores (A x B) + C + D.~The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented."|Baseline to Week 4 and Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.|||units on a scale||Standard Deviation|Mean
2810495|NCT00447772|Secondary|Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0-3 points)~Subscore D: severity and duration of tremor (range: 0-4 points).~The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 12 visit is presented."|Baseline to Week 12|The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for the Week 12 visit are reported.|||units on a scale||Standard Deviation|Mean
2810496|NCT00447772|Primary|Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12)|"The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores:~Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points)~Subscore B: duration of movement (values 1 or 2)~Subscore C: severity and duration of shoulder elevation (range: 0-3 points)~Subscore D: severity and duration of tremor (range: 0-4 points).~The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD.~The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented."|Baseline to Week 4 or Week 12 (up to 12 weeks)|The Intention to Treat (ITT) Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale.|||units on a scale||Standard Deviation|Mean
2810497|NCT00447603|Secondary|Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.||||||
2810498|NCT00447603|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.||||||
2810499|NCT00447603|Primary|Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.||||||
2810506|NCT00447590|Primary|Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.|"Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.~Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years."|1 year|Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND).|||percentage of participants|||Number
2810507|NCT00447499|Secondary|Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination|Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26). Fifty-six of patients had data at Week 24.|||On a Scale from -6 to 6||Standard Deviation|Mean
2810508|NCT00447499|Secondary|Total Symptom Questionnaire Score at Week 24/Termination|Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.|24 Weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).|||On a Scale from -10 to 10||Standard Deviation|Mean
2810509|NCT00447499|Secondary|Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.|||ng/mL||Standard Deviation|Mean
2810510|NCT00447499|Secondary|Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.|||Percent of Participants|||Number
2810511|NCT00447499|Secondary|Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study|Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.|24 weeks|Patients switched directly from octreotide who had IGF-1 level measured at the end of study.|||Percent of Participants|||Number
2810512|NCT00447499|Secondary|Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.|Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.|24 weeks|Patients switched directly from octreotide.|||Percent of Participants|||Number
2810513|NCT00447499|Primary|The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.|The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).|||Percentage of Participants|||Number
2810514|NCT00447421|Secondary|Phase 2: Overall Survival|Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.|baseline to date of death from any cause|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||months||Standard Deviation|Mean
2810515|NCT00447421|Secondary|Phase 2: Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||months||Standard Deviation|Mean
2810516|NCT00447421|Secondary|Phase 2: Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||months||Standard Deviation|Mean
2810517|NCT00447421|Secondary|Phase 2: Complete Response Rate|Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.|baseline to measured response time|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||participants|||Number
2810518|NCT00447421|Secondary|Phase 1: Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.|||participants|||Number
2810852|NCT00445211|Secondary|Intra-aortic Balloon Pump-related Death During the Index Hospitalization||0-4 days post surgery||||Participants|||Count of Participants
2810519|NCT00447421|Primary|Phase 2: Overall Response Rate|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.|||participants|||Number
2810520|NCT00447421|Primary|Phase 1: Maximum Tolerated Dose||every cycle|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).|||milligrams per square meter||Standard Deviation|Mean
2810521|NCT00447382|Secondary|Adverse Events||Weeks 0-52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||events|||Number
2810522|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Total Protein)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||g/dL||Standard Deviation|Mean
2810523|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Sodium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
2810524|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Potassium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
2810525|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||U/L||Standard Deviation|Mean
2810526|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Creatinine)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation.|||Umol/L||Standard Deviation|Mean
2810527|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALP = alkaline phosphatase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||U/L||Standard Deviation|Mean
2810528|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALAT = alanine aminotransferase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||U/L||Standard Deviation|Mean
2810529|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Albumin)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||g/dL||Standard Deviation|Mean
2810530|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Leucocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
2810531|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Thrombocytes)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||10^9/L||Standard Deviation|Mean
2810532|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Neutrophils)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
2810870|NCT00445146|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events|Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to Week 408 plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2810533|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Monocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
2810534|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Lymphocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
2810535|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Haemoglobin)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
2810536|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Eosinophils)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
2810537|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Basophilis)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) of white blood cells||Standard Deviation|Mean
2810538|NCT00447382|Secondary|Change From Baseline in Total Antibodies|Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||ratio||Standard Error|Mean
2810539|NCT00447382|Secondary|Change From Baseline in Detemir Specific Antibodies|Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||ratio||Standard Error|Mean
2810540|NCT00447382|Secondary|Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])|"point is Before Breakfast~point is 120 minutes after Breakfast~point is Before Lunch~point is 120 minutes after Lunch~point is Before Dinner~point is 120 minutes after Dinner~point is at Bedtime~point is At 03:00 A.M.~point is Before Breakfast the Following Day"|week 0, 26 and 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Deviation|Mean
2810541|NCT00447382|Secondary|Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])||week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||mmol/L||Standard Error|Mean
2810542|NCT00447382|Secondary|Glycaemic Control Parameters (Change in HbA1c)|HbA1c (Glycosylated haemoglobin).|week 0, week 52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
2810543|NCT00447382|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.|Weeks 0-52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||episodes|||Number
2810544|NCT00447382|Primary|Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies|Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.|||ratio||Standard Error|Mean
2810545|NCT00447330|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years after study start date|All patients who received treatment are included in the analysis population. However, 2 patients who never started treatment before leaving the study were excluded from this analysis of survival time.|||survival time in months||90% Confidence Interval|Median
2810871|NCT00445146|Primary|Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event||Up to Week 408 plus 30 days|Safety Analysis Set: enrolled participants who received at least 1 dose of EVG|||percentage of participants|||Number
2810546|NCT00447330|Secondary|Response Rate|The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|Every 9 weeks for up to 1 year|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2810547|NCT00447330|Secondary|To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma|Number of subjects who experienced an adverse event|Every 21 days||||participants|||Number
2810548|NCT00447330|Primary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years from study start date|All patients with at least one scheduled restaging who received treatment. However, an additional 3 patients who progressed before treatment are not included in this analysis.|||survival time in months||90% Confidence Interval|Median
2810549|NCT00447278|Secondary|Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores|Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.|Baseline, 6 months|All randomized participants who received at least one dose of study drug and had non-missing values.|||correlation coefficient|||Number
2810550|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)|CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of adolescent participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n=27, OEST n=31). Their data at 6 months was taken as baseline for the 12 month change."|||T-Scores of units on a scale||Standard Deviation|Mean
2810551|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)|CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of child participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 112, OEST n=124). Their data at 6 months was taken as baseline for the 12 month change."|||T-Scores of units on a scale||Standard Deviation|Mean
2810552|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||units on a scale||Standard Deviation|Mean
2810553|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||units on a scale||Standard Deviation|Mean
2810554|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)|"The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0=never or not at all, 1=sometimes or somewhat, 2=often or much, 3=very often or very much). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst)."|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||units on a scale||Standard Deviation|Mean
2810555|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)|CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||T-Scores of units on a scale||Standard Deviation|Mean
2810556|NCT00447278|Secondary|Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain|CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.|||T-Scores of units on a scale||Standard Deviation|Mean
2810557|NCT00447278|Primary|Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain|CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 6 months|Number of participants who received at least one dose of study drug and did not have a missing value. Results for Last Observation Carried Forward (LOCF) are included.|||T-Scores of units on a scale||Standard Deviation|Mean
2810558|NCT00447265|Secondary|Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24|"Reported here are the participant SF-36 Mental Component scores at baseline and week 24. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions.[1] The Mental Component score of the SF-36 ranges from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.~[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey. Med Care. 1992; 30:473-483"|Baseline, Week 24||||Score on a scale|||Number
2810559|NCT00447265|Secondary|Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24|"Reported here is the participant baseline and week 24 SF-36 Physical Component scores. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, body pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions[1]. The Physical Component scores of the SF-36 range from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.~[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey Med Care. 1992; 30:473-483."|Baseline, Week 24||||Score on a scale|||Number
2810560|NCT00447265|Secondary|Number of Participants With an A to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Renal Score|Reported here is the number of participants with a change in their BILAG Renal Score from A (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum renal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system|Baseline, Week 24||||Participants|||Number
2810561|NCT00447265|Secondary|Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score|Reported here is the number of participants with a change in their BILAG Musculoskeletal Score from B (at baseline) to D (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum musculoskeletal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24||||Participants|||Number
2810562|NCT00447265|Secondary|Number of Participants With a C to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Mucocutaneous Score|Reported here is the number of participants with a change in their BILAG Mucocutaneous Score from C (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0). A maximum mucocutaneous score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24||||Participants|||Number
2810563|NCT00447265|Secondary|Participant Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Baseline and at Early Study Withdrawal Visit|Reported here is the baseline and week 39 Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) scores. The SLEDAI is a concise measure of lupus disease activity with excellent test-retest reliability and high responsiveness to clinically important changes in the disease. The total score is derived from ratings on 24 conditions plus the Physician's Global Assessment; 0 indicates inactive disease and the maximum theoretical score is 105, with higher scores representing increased disease activity.|Baseline, Week 39 (Early Study Withdrawal Visit)||||Points on a scale|||Number
2820858|NCT00377832|Secondary|Rate of Diagnosis of Clinical Chorioamnionitis|Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.|Labor--up to 24 hours||||participants|||Number
2810564|NCT00447265|Secondary|Time to Participant's Renal Response|"Time to when participant achieved a renal response[1]~[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|First 24 Weeks of Study Period||||Weeks|||Number
2810565|NCT00447265|Secondary|Percent of Participants Who Achieved a Renal Response at Week 24|"Percent of study participants who achieved a renal response at 24 weeks.[1]~[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|Week 24||||Percent of Participants|||Number
2810566|NCT00447265|Secondary|Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit|Number of participant AEs during the trial. This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0.|39 Weeks||||Events|||Number
2810567|NCT00447265|Primary|Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study|"Number of adverse events (AEs) or serious adverse events (SAEs) Grade 3 or higher experienced by participant over the duration of the treatment period. [1]~[1] This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0."|24 Weeks||||Events|||Number
2810568|NCT00447226|Secondary|Incidence of ErbB2-positive Participants|The number of ErbB2-positive participants (determined by FISH assay) compared to the total number of participants screened was to be recorded. Over-expression of ErbB2 has been correlated with an overall poor prognosis. Data were not analyzed, due to early study termination.|Screening|All participants who were screened to determine their eligibility to enter into the study|||participants per total screened|||Number
2810569|NCT00447226|Secondary|Incidence of MET Amplification in Gastric Cancer|The number of gastric cancer participants with MET amplification (determined by fluorescence in situ hybridization [FISH] assay) compared to the total number of gastric cancer participants screened was to be recorded. Amplification of the MET gene has been reported to be related to carcinogenesis, progression of gastric cancer, and poor prognosis. Data were not analyzed due to early study termination.|Performed on archived tissue collected at screening.|All participants with gastric cancer who were screened to determine their eligibility to enter into the study|||participants per total screened|||Number
2810570|NCT00447226|Secondary|Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1|"CA-125 is a tumor marker, found in greater concentration in tumor cells than other cells of the body. In particular, CA-125 is present in greater concentration in ovarian cancer cells than in other cells. A decreasing level generally indicates that therapy has been effective, whereas an increasing level indicates tumor recurrence."|Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks)|Participants with ovarian cancer. The number of participants for whom there are data varies at each time point, depending on how many participants had CA-125 samples.|||participants|||Number
2810571|NCT00447226|Secondary|Time to Disease Progression (TTP)|"Time to disease progression was calculated as the time from the start of treatment to disease progression or death due to disease progression. For participants who did not progress, the date of last contact was used and for those who died due to other causes, the date of death was used. The word used for such participants was censored. As the median value in the placebo arm was not reached (2 participants were censored and 2 were ongoing), results for the placebo arm are not displayed in the table below."|From start of treatment to disease progression/death (up to 83.3 weeks)|All Treated: all participants who received at least one dose of open-label lapatinib.|||weeks||95% Confidence Interval|Median
2810572|NCT00447226|Secondary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Data were not analyzed due to early study termination."|From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.|||weeks||95% Confidence Interval|Median
2810573|NCT00447226|Secondary|Duration of Response|Duration of response was calculated as the time from first documented partial response (PR; >=30% decrease in the measurements of the largest lesions) or complete response (CR; disappearance of all lesions) until disease progression, the time when the participant began a new anti-cancer therapy, or death. Data were not analyzed due to early study termination.|(assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.|||weeks||95% Confidence Interval|Median
2810574|NCT00447226|Primary|Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization|The percentage of participants who did not show signs of progressive disease 12 weeks after receiving lapatinib or placebo in Stage 2 of the study (participants who maintained SD in Stage 1 were randomized to either lapatinib or placebo) was measured. Formal statistics for treatment comparison were not performed, due to early study termination. The percentage of participants displayed below includes those with CR + PR + SD.|Week 12 after randomization.|Intent-to-Treat Population: all participants randomized to study treatment in Stage 2|||percentage of participants|||Number
2810651|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
2810575|NCT00447226|Primary|Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose|Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), >=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, >=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.|Week 12|All treated: all participants who received at least one dose of open-label lapatinib.|||participants|||Number
2810576|NCT00447122|Primary|Number of Patients Who Survived at 4 Months: Overall Survival||4 months||||participants|||Number
2810577|NCT00447083|Secondary|Pain Scores of the UV and Non-UV Exposure (Phase II)|The pain scores were assessed using a Likert Scale. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain.|4 weeks post-treatment||||score on a scale||Standard Error|Mean
2810578|NCT00447083|Secondary|Post-treatment Pain Scores- Likert Scale (Phase I)|As a secondary outcome, the post-treatment pain scores between the UV and non-UV exposures given on the first day the dose is given will be compared. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain|2 weeks||||score on a scale||Standard Deviation|Mean
2810579|NCT00447083|Primary|Pain Score- Likert Scale(Phase II)|"Pain will be assessed on an 11-point pain scale where 0=no pain and 10=worst possible pain. A 30% improvement in reported pain will be considered a treatment success."|6 weeks||||score on a scale||Standard Error|Mean
2810580|NCT00447083|Primary|Pain Relief Success Rates (Phase I)|Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.|2 weeks||||percentage of exposures with relief|||Number
2810581|NCT00447057|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline up to 42.2 months|All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.|||participants|||Number
2810582|NCT00447057|Secondary|Percentage of Participants Surviving at 1 Year|Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.|Baseline to date of death from any cause up to 1 year|"Includes nonsquamous population only.~On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall."|||Percentage participants with OS ≥1 year||95% Confidence Interval|Median
2810583|NCT00447057|Secondary|Overall Survival (OS)|OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.|Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.|Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored|||months||95% Confidence Interval|Median
2810584|NCT00447057|Secondary|Time to Treatment Failure (TTTF)|"Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than protocol complete or satisfactory response. For participants who discontinued due to protocol complete or satisfactory response, or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date."|"Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than protocol complete or satisfactory response. Maximum follow-up was from Baseline to 32.2 months"|Includes nonsquamous population only.|||months||95% Confidence Interval|Median
2810585|NCT00447057|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)|"CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100."|Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.|||percentage of participants||95% Confidence Interval|Number
2810586|NCT00447057|Secondary|Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)|"Per RECIST:~CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100."|Baseline to measured PD. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.|||percentage of participants||95% Confidence Interval|Number
2810587|NCT00447057|Primary|Progression Free Survival (PFS)|PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.|Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months|"Includes Nonsquamous population only.~In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy.~In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy."|||months||95% Confidence Interval|Median
2810652|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
2810588|NCT00447005|Secondary|The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 795 days|Participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug (Anti-tumor Response Analysis Set).|||participants|||Number
2810589|NCT00447005|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.|Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation|Participants who received at least one study drug and completed pharmacodynamic blood sampling for at least one day (Pharmacodynamic Analysis Set); n= number of participants assessed.|||percent change||Full Range|Median
2810590|NCT00447005|Secondary|Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||ratio||Standard Deviation|Mean
2810591|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose|Dosing Interval was 12 hours in this study.|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||ng*h/mL||Standard Deviation|Mean
2810592|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||hours||Full Range|Median
2810593|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.|||ng/mL||Standard Deviation|Mean
2810594|NCT00447005|Secondary|Terminal Phase Plasma Half-Life (t1/2): Single Dose|t1/2 is the time measured for the plasma concentration to decrease by one half.|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||hours||Standard Deviation|Mean
2810595|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||ng*hr/mL||Standard Deviation|Mean
2810596|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||hours||Full Range|Median
2810597|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.|||ng/mL||Standard Deviation|Mean
2810598|NCT00447005|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.|Up to 795 days of treatment plus 28-days follow-up|All subjects who received at least 1 dose of the study drug.|||participants|||Number
2810599|NCT00446992|Primary|LDL||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
2810600|NCT00446992|Primary|HDL||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
2810601|NCT00446992|Primary|Cholesterol Total||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
2810602|NCT00446992|Primary|Triglycerides||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
2810603|NCT00446992|Primary|IL-6||Baseline and 4 week intervals||||pg/mL||Standard Deviation|Mean
2810604|NCT00446992|Primary|Hemoglobin A1c||Baseline and 4 week intervals||||percentage||Standard Deviation|Mean
2810605|NCT00446992|Primary|Fasting Insulin||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
2810606|NCT00446992|Primary|Fasting Glucose||Baseline and 4 week intervals||||mg/dL||Standard Deviation|Mean
2810607|NCT00446992|Primary|Body Mass Index||Baseline and 4 week intervals||||kg/m^2||Standard Deviation|Mean
2810608|NCT00446966|Primary|Number of Participants Who Developed Postoperative Atrial Fibrillation|The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.|14 days|Intention to treat|||participants|||Number
2810609|NCT00446849|Secondary|Endoscopic Remission of UC During the Maintenance Phase at 12 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|12 Months|MPEP with non-missing data at 12 months.|||Participants|||Number
2810610|NCT00446849|Secondary|Quiescent UC During the Maintenance Phase at 12 Months|Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|12 Months|MPEP with non-missing data at 12 months.|||Participants|||Number
2810611|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100.|12 months|MPEP with non-missing data for clinical recurrence at 12 months.|||Percent of participants|||Number
2810612|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100.|6 Months|MPEP with non-missing data for clinical recurrence at 6 months.|||Percent of participants|||Number
2810613|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|12 Months|MPEP|||participants|||Number
2810614|NCT00446849|Primary|Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|6 months|Maintenance phase efficacy population (MPEP) includes all subjects who, during the maintenance phase, took at least 1 dose of study medication and had at least 1 post-dose efficacy assessment.|||participants|||Number
2810615|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810616|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810617|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810618|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810619|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810620|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810910|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to collect a minimum of 3*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥3*10^cells/kg collected during apheresis.|||days||Full Range|Median
2810621|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810622|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810623|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810624|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810625|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810626|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810627|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 1, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||scores on a scale||Standard Deviation|Mean
2810628|NCT00446797|Secondary|Subject Assessment of Normal Function / Activity|"Subject response to question: How does your ankle injury affect your walking and normal activity? Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can't resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
2810629|NCT00446797|Secondary|Pain Relief - MITT Population|"Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete."|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
2810630|NCT00446797|Secondary|Physician Global Assessment of Ankle Injury|Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)|Days 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
2810631|NCT00446797|Secondary|Subject's Global Assessment of Ankle Injury|"Subject response to question: Considering all the ways your ankle injury affects you, how are you doing today? Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)."|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment|||participants|||Number
2810632|NCT00446797|Secondary|Number of Subjects Responding (Improving) - MITT Population|The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).|||participants|||Number
2810653|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
2810633|NCT00446797|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population|"Assessment of ankle pain by VAS: 100 mm horizontal line, left end being No Pain & right end being Worst Possible Pain. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline"|Baseline and days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).|||scores on a scale||Standard Deviation|Mean
2810634|NCT00446797|Primary|Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population|"Assessment of ankle pain by VAS: 100 mm horizontal line with left end being No Pain & right end being Worst Possible Pain. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline"|Baseline and day 3|Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).|||scores on a scale||Standard Deviation|Mean
2810635|NCT00446654|Primary|Change in Baseline to 3 Months in Best Corrected Visual Acuity|"Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read).~The outcome measure presented is the difference in LogMAR between baseline and at three months."|Baseline and 3 months|Analysis was performed on all patients who received at least one treatment.|||logMAR||Standard Deviation|Mean
2810636|NCT00446654|Secondary|To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization||3 months|||||||
2810637|NCT00446654|Secondary|Safety of 2-weekly or 4-weekly Administration of CGC-11047||3 months|||||||
2810638|NCT00446641|Secondary|Post-treatment ARU|mean of ARU value of individual participants after 4 weeks treatment|after 4 weeks treatment||||ARU||Standard Deviation|Mean
2810639|NCT00446641|Secondary|Difference of Post-treatment ARU and Baseline ARU|summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients|baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication||||change of ARU measured||Standard Deviation|Mean
2810640|NCT00446641|Secondary|Any Bleeding Complications|any bleeding events causing medical attention|events ocurred during study medication after randomization||||participants|||Number
2810641|NCT00446641|Secondary|Fatal or Major Bleeding Complications;|Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|events ocurred during study medication after randomization||||participants|||Number
2810642|NCT00446641|Secondary|Bleeding Time (BT)|for evaluation of the extent of the bleeding time prolongation by additional cilostazol|4 weeks after reatment||||seconds||Standard Deviation|Mean
2810643|NCT00446641|Secondary|Aspirin Resistance (ARU ≥ 500)|The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values|4 weeks after reatment||||participants|||Number
2810644|NCT00446641|Primary|Aspirin Resistance (ARU ≥ 550)|The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients|4 weeks after treatment||||participants|||Number
2810645|NCT00446563|Secondary|Percentage of Participants Who Experienced Adverse Events (AEs)|An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.|Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.|||Percentage of participants|||Number
2810646|NCT00446563|Secondary|Percentage of Participants Achieving Target Blood Pressure at Week 52|Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.|Week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||Percentage of participants|||Number
2810647|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.|||mg/l||Standard Deviation|Mean
2810648|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.|||pg/ml||Standard Deviation|Mean
2810649|NCT00446563|Secondary|Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||mm||Standard Deviation|Mean
2810650|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||cm˄2||Standard Deviation|Mean
2810654|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||ml||Standard Deviation|Mean
2810655|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI|Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.|Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||Percentage||Standard Deviation|Mean
2810656|NCT00446563|Secondary|Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||mm||Standard Deviation|Mean
2810657|NCT00446563|Secondary|Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||mm||Standard Deviation|Mean
2810658|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||g/m˄2||Standard Deviation|Mean
2810659|NCT00446563|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.|||g/m˄2||Standard Deviation|Mean
2810660|NCT00446550|Secondary|Change From Baseline To End Of Treatment In β-glucocerebrosidase (GCase) Levels In White Blood Cells (WBC)|GCase is a biomarker used to assess the PD effects of afegostat tartrate. Blood samples were collected to assess GCase levels in WBC. The baseline value was defined as the last non-missing value before the start of study drug.|Baseline, Day 169|PD Population: all participants who were included in the Safety Population and had a baseline and at least 1 post-baseline PD measurement.|||picomole/minute/mg||Standard Deviation|Mean
2810661|NCT00446550|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through the end of follow-up (Day 183) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Day 183|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2810662|NCT00446511|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.|||mmHg||Standard Deviation|Mean
2810663|NCT00446511|Secondary|Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20|24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.|Core Baseline (Week 0) to Week 20|ABPM population: All ITT patients who received the 24-hour ambulatory blood pressure monitoring (ABPM) measurements at both baseline and Week 20. Patients were excluded if their baseline ABPM was measured after active treatment dose (considered invalid baseline).|||mmHg||Standard Deviation|Mean
2810664|NCT00446511|Secondary|Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26|Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.|Week 26|The extension ITT population consisted of all extension patients that had both baseline and at least one post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic blood pressure) during the extension. Patients were analyzed according to the treatment they were assigned to at the beginning of their extension.|||Percentage of patients|||Number
2810756|NCT00445744|Primary|Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity|Number of patients with regimen-related liver toxicity. Diagnoses will be made according to the established criteria initially proposed in 1984 by McDonald et al.|Up to day +20||||Participants|||Count of Participants
2810665|NCT00446511|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.|||mmHg||Standard Deviation|Mean
2810666|NCT00446511|Primary|Number of Patients With Adverse Events||Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)|Extension safety population|||Participants|||Number
2810667|NCT00446459|Secondary|The Number of Transplants With a Negative Crossmatch at Transplant.|The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months.|Number of Transplants with a Negative Crossmatch.||||Participant|||Number
2810668|NCT00446459|Secondary|The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL).|The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months.|Enrollment to month 12.||||Participant|||Number
2810669|NCT00446459|Secondary|The Number of Kidney Transplant up to 12 Months.|The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|Enrollment to month 8 or month 12 post enrollment.||||Participants|||Number
2810670|NCT00446459|Primary|The Number of Subjects With a 10% Decrease in PRA Level at Month 8.||Enrollment to month 8||||Participant|||Number
2810671|NCT00446459|Secondary|The Number of Subjects With Significant Infections up to Month 12.|The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|From enrollment to month 12.|Forty five subjects were screened, of these 37 received MMF.|||Participants|||Number
2810672|NCT00446446|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug.|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.|Safety analysis set (all enrolled participants who received at least 1 dose of panitumumab)|||participants|||Number
2810673|NCT00446446|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first).|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set|||months||95% Confidence Interval|Median
2810674|NCT00446446|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment.~PFS was analyzed using the Kaplan-Meier method."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set|||months||95% Confidence Interval|Median
2810675|NCT00446446|Secondary|Time to Progression|Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set|||months||95% Confidence Interval|Median
2810676|NCT00446446|Secondary|Rate of Disease Control|"Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set with measurable disease at Baseline|||percentage of participants||95% Confidence Interval|Number
2810911|NCT00444912|Secondary|Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration|Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).|Days 4-5|Evaluable population of participants with peripheral blood CD34+ measurements on Days 4 and 5.|||fold increase||Full Range|Median
2810677|NCT00446446|Secondary|Duration of Response|"Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method.~PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with an objective response|||months||95% Confidence Interval|Median
2810678|NCT00446446|Secondary|Time to Response|Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with objective responses|||weeks||Inter-Quartile Range|Median
2810679|NCT00446446|Primary|Objective Response Rate|Assessments are based on investigator's review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set (all enrolled participants who received at least 1 dose of panitumumab) with measurable disease at Baseline|||percentage of participants||95% Confidence Interval|Number
2810680|NCT00446290|Primary|Number of Participants With DLTs|Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment. The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment. Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients|2 years|All patients who were initially enrolled in dose escalation scheme.|||participants|||Number
2810681|NCT00446264|Secondary|Number of Adverse Events|The number of adverse events related to the procedure and to the immunosuppression|1 year||||number events|||Number
2810682|NCT00446264|Secondary|Percentage of Time Spent in Hypoglycemia (<0.70 mg/L)|percentage of time spent in hypoglycemia derived from CGMS (Continuous Glucose Monitoring System)|1 year||||percentage of time||Standard Deviation|Mean
2810683|NCT00446264|Secondary|HbA1c < 6.5%|The percentage of subjects with HbA1c < 6.5% at 1 year after the first transplant|1 year||||Percentage of participants||Standard Deviation|Mean
2810684|NCT00446264|Secondary|Plasma C-peptide|Level of plasma C-peptide at 1 year after the first transplant|1 year||||ng/ml||Standard Deviation|Mean
2810685|NCT00446264|Secondary|Hypoglycemic Events|Percentage of subjects free of severe hypoglycemic events from day 0 to day 365 with the day of transplant designated day 0|day 0 to day 365||||Percentage of patients||Standard Deviation|Mean
2810686|NCT00446264|Primary|Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year|The percentage of insulin independents subjects with an HbA1c less than 6.5% at one year after last transplant|1 year||||Percentage of patients||Standard Deviation|Mean
2810687|NCT00446251|Secondary|The Number of Subjects With a Negative Crossmatch at the Time of Transplant.||Month 12 from start of study|As per protocol each subject was entered with intention to treat.|||Participants|||Number
2810688|NCT00446251|Secondary|The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion.||Month 12 from start of study||||Participants|||Number
2810689|NCT00446251|Primary|The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion.|the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion|Month 6 from start of study|12 subjects received the full dose of Rituximab AND continued to month 6 post infusion.|||Participants|||Number
2810690|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||scores on a scale||Standard Deviation|Mean
2810691|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Scores on a scale||Standard Deviation|Mean
2810912|NCT00444912|Secondary|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis.|Days 5-8|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.|||CD34+ cells (*10^6 / kg)||Full Range|Median
2810692|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Standard Deviation|Mean
2810693|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Standard Deviation|Mean
2810694|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'|Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810695|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810696|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810697|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810698|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810699|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810700|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810701|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.|||participants|||Number
2810702|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal Maturation Value|Calculated as (percentage of superficial cells) + 0.5 * (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||Percentages of cells||Standard Deviation|Mean
2810703|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal pH|Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.|||(pH)||Standard Deviation|Mean
2810704|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Scorese on a scale||Full Range|Median
2810705|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Scores on a scale||Full Range|Median
2810706|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Full Range|Median
2810926|NCT00444626|Secondary|Participant Product Preference at Week 24|Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Participants|||Number
2810707|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (Intention to Treat (ITT)) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.|||Hot Flushes per week||Full Range|Median
2810708|NCT00446147|Secondary|Number of Patients With Hand-foot Syndrome|Number of patients with any grade of hand-foot syndrome|Up to 2 years||||participants|||Number
2810709|NCT00446147|Primary|Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome|A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.|Up to 2 years||||miligram per square meter||95% Confidence Interval|Median
2810710|NCT00446134|Secondary|Relapsers at Follow-Up Visit 24|Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.|Follow-Up Week 24|The analysis was performed using patients who had undetectable HVC RNA at their last visit on drug.|||Participants|||Number
2810711|NCT00446134|Secondary|Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24||Treatment Week Follow-Up 24|This analysis was performed using the Intent-to-Treat Population (ITT); undetectable HCV RNA defined as <100 copies/mL;Patients with a missing value at TW 12, TW 24 were considered Non-responders (detectable); a responder is defined as a patient with undetectable HCV RNA at FW 24 after achieving EVR at TW 12 and undetectable status at TW 24|||Participants|||Number
2810712|NCT00446134|Secondary|Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24|The primary safety endpoint will be the numbers of patients with hemoglobin <10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed.|Treatment Week Follow-Up 24|The secondary analysis was performed using the Safety Population and 275 patients who received at least one dose of study drug were analyzed for safety.|||Participants|||Number
2810713|NCT00446134|Primary|Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.|The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as <100 copies/mL serum HCV RNA. A PR is defined as < 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.|Treatment Week 12|The primary efficacy analysis was performed using the Intent-to-Treat (ITT) population and 275 patients who received at least one dose of study drug were analyzed for efficacy.|||Participants|||Number
2810714|NCT00446095|Secondary|Overall Survival (OS)|OS: Time from date of first study drug administration to the date of death.|Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Days||95% Confidence Interval|Median
2810715|NCT00446095|Secondary|Progression Free Survival (PFS)|"PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the Revised Response Criteria for Malignant Lymphoma(Cheson 2007) or the date of death due to any cause, whichever occurred first."|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Days||95% Confidence Interval|Median
2810716|NCT00446095|Primary|"Clinical Benefit Rate as Assessed According to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)."|Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Participants|||Number
2810717|NCT00446095|Primary|"Overall Response Rate as Assessed According to theRevised Response Criteria for Malignant Lymphoma (Cheson 2007)."|Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.|||Participants|||Number
2810718|NCT00446030|Secondary|Disease-free Survival (DFS) & Overall Survival (OS) of Participants|"DFS is the time from study registration until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. For participants who are removed from the study follow-up prior to documentation of the tumor recurrence, DFS will be censored at the last date the participant was known to be disease-free.~OS is the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive."|up to 10 years|"Based on a protocol amendment~this study was shortened from 10 years to 2 years~the efficacy endpoints of disease free survival, and overall survival were deleted from the protocol.~Therefore, no analysis was performed for DFS or OS."|||Months||95% Confidence Interval|Median
2810719|NCT00446030|Primary|Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)|The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.|up to 2 years|Safety population - all participants who received at least 1 dose of any study treatment.|||Percentage of Participants||95% Confidence Interval|Mean
2810720|NCT00445939|Secondary|Clinical Remission (CDAI <150) at Week 6 and Week 8|The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8|Week 6 and Week 8|Subjects who were rated as non-responders (CDAI reduction < 70) in the evaluation of clinical remission (CDAI<150) at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg.|||Participants|||Number
2810721|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period B|The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.|Week 6 and Week 8|Full analysis set - subjects rated as non-responders (did not attain CDAI reduction >= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg.|||Participants|||Number
2810722|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period A|The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4.|Weeks 2 and Week 4|The secondary efficacy analysis was performed using descriptive statistics in randomized subjects who received at least one dose of study drug (full analysis set) in the three treatment groups: Adalimumab 160 mg/80 mg, adalimumab 80mg/40 mg, and placebo.|||participants|||Number
2810723|NCT00445939|Secondary|Clinical Remission (CDAI < 150) at Week 2|Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.|Week 2|Subjects with a clinical remission (CDAI <= 150) in the adalimumab 160 mg (Week 0/80 mg (Week 2) and adalimumab 80 mg (Week 0)/40 mg (Week 2) in full analysis set using Non-responder Imputation.|||Participants|||Number
2810724|NCT00445939|Primary|The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4|CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.|4 Weeks|The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations.|||Particpants|||Number
2810725|NCT00445887|Other Pre-specified|Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue|The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide|Surgical specimen (4-6 weeks after entry)|Patients with evaluable slides|||proportion of total cells||Inter-Quartile Range|Median
2810726|NCT00445887|Secondary|Patients With High Expression of Transforming Growth Factor-beta 1||Baseline to time of surgery (4 to 6 weeks)|All eligible, treated and evaluable for Transforming Growth factor-beta|||Participants|||Count of Participants
2810727|NCT00445887|Secondary|Proportion of Proliferation as Measured by Ki-67||Time of surgery (4 to 6 weeks after entry)|All eligible, treated patients with an evaluable sample.|||Proportion of cells exhibiting Ki-67||Inter-Quartile Range|Median
2810728|NCT00445887|Primary|Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0|Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.|Up to 20 weeks|All eligible and treated patients who had toxicity on study.|||Participants|||Count of Participants
2810729|NCT00445887|Primary|Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue|The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.|Surgical specimen (4 - 6 weeks after entry)|Patients with evaluable slides. 14 of the cases did not have ovarian tissue available for evaluation. 50 cases were available for the primary analysis.|||proportion of total cells||Inter-Quartile Range|Median
2810730|NCT00445848|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.|Eligible patients who had received the protocol treatments were included in the adverse event summaries.|||Participants|||Number
2810731|NCT00445848|Secondary|Response Rate (Complete and Partial)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~All target measurable lesions must be assessed using the same techniques as baseline."|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|Only patients with measurable disease at baseline were included in the analysis. 66 of 85 patients (78%) had measurable disease at baseline.|||participants|||Number
2820859|NCT00377832|Secondary|Rate of Subsequent Development of Maternal Fever|Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.|Labor--up to 24 hours||||participants|||Number
2810732|NCT00445848|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.||||months||95% Confidence Interval|Median
2810733|NCT00445848|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.||||months||95% Confidence Interval|Median
2810734|NCT00445770|Other Pre-specified|Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses||Weeks 12, 24, 52|mITT; n = evaluable participants at the specified time point.|||nanograms per milliliter (ng/mL)||Standard Error|Mean
2810735|NCT00445770|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mm/hr||Standard Deviation|Mean
2810736|NCT00445770|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mg/dL||Standard Deviation|Mean
2810737|NCT00445770|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
2810738|NCT00445770|Secondary|Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS: weighted calculation of joint tenderness score (Ritchie Articular Index[RAI]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
2810739|NCT00445770|Secondary|Percentage of Participants With an ACR70 Response|ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Percentage of participants|||Number
2810740|NCT00445770|Secondary|Percentage of Participants With an ACR50 Response|ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Percentage of participants|||Number
2810741|NCT00445770|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Percentage of participants|||Number
2810742|NCT00445770|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
2810743|NCT00445770|Secondary|Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|"100mm line (VAS) marked by participant. Participants asked, In general how would you rate your health over the last 2-3 weeks? 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mm||Standard Deviation|Mean
2810744|NCT00445770|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||mm||Standard Deviation|Mean
2810745|NCT00445770|Secondary|Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Minutes||Standard Deviation|Mean
2810746|NCT00445770|Secondary|Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
2810747|NCT00445770|Secondary|Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Scores on a scale||Standard Deviation|Mean
2810748|NCT00445770|Secondary|Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF|||Tender Joints||Standard Deviation|Mean
2810749|NCT00445770|Secondary|Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Modified ITT (mITT) population: participants who received at least 1 dose of the assigned test article; Last Observation Carried Forward (LOCF)|||Swollen Joints||Standard Deviation|Mean
2810750|NCT00445770|Secondary|Percentage of Participants With no Progression of Joint Destruction at Week 52|Absence of joint destruction defined by 3 categories (mTSS change <=0.5, <=3.0, and <smallest detectable difference [SDD] where SDDs were scores >3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).|Baseline and Week 52|rITT|||Percentage of participants|||Number
2810751|NCT00445770|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT|||Scores on a scale||Standard Error|Mean
2810752|NCT00445770|Secondary|Change From Baseline in Erosion Score at Weeks 24 and 52|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT|||Scores on a scale||Standard Error|Mean
2810753|NCT00445770|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 24|rITT|||Scores on a scale||Standard Error|Mean
2810754|NCT00445770|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 52|Radiographic intent-to-treat (rITT) population: all participants who received at least 1 dose of the assigned test article and provided radiographic data for baseline and at least 1 post-baseline visit|||Scores on a scale||Standard Error|Mean
2810755|NCT00445744|Primary|Non-relapse Mortality (NRM) (Patients With AML/MDS)|Cumulative incidence rate with death as a competing risk, assessed at day 100.|Up to day 200||||percent|||Number
2813310|NCT00429364|Secondary|Annual Rate of Change in Arm Span to Height Ratio||Up to 3 years following randomization.|All randomized participants whose arm span to height ratios were measured at baseline and at any of the follow-up visits.|||1/year||Standard Error|Least Squares Mean
2810757|NCT00445705|Secondary|Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4|"PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: improved= score of 1-3; no change=score of 4; and worse=score of 5-7."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all randomized patients who started study (randomized) and who received the study medication with at least one post-treatment mean daily-average-pain score.|||Percentage of Patients|||Number
2810758|NCT00445705|Secondary|Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4|Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
2810759|NCT00445705|Secondary|Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4|"Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The average pain question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain."|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
2810760|NCT00445705|Primary|Change From Baseline in Mean Daily-Average-Pain Score at Week 4|Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
2810761|NCT00445692|Secondary|Survival|number of patients alive or dead|From date of transplant until the date of death from any cause, assessed up to 10.25 years||||Participants|||Count of Participants
2810762|NCT00445692|Primary|Time to Disease Progression|International Myeloma Working Group Uniform Response Criteria was used|Up to 10.25 years|Measured among the 20 patients who progressed|||months||Full Range|Median
2810763|NCT00445692|Primary|Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3||First year of therapy||||episodes|||Number
2810764|NCT00445679|Secondary|Covi Anxiety Scale Score Mean Change From Baseline|Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||scores on a scale||95% Confidence Interval|Mean
2810765|NCT00445679|Secondary|Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline|HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||scores on a scale||95% Confidence Interval|Mean
2810766|NCT00445679|Secondary|Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline|The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||scores on a scale||95% Confidence Interval|Mean
2810767|NCT00445679|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and 8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||units on a scale||95% Confidence Interval|Mean
2811029|NCT00443820|Primary|Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks|Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)|||Percentage of participants|||Number
2810768|NCT00445679|Secondary|Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores|CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||subjects|||Number
2810769|NCT00445679|Secondary|Clinical Global Impressions Scale-Improvement (CGI-I) Scores|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.|||subjects|||Number
2810770|NCT00445679|Primary|Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.|||percentage of responders|||Number
2810771|NCT00445601|Secondary|Rate of Disease Worsening Over 2 Years|Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.|Up to 2 years|TURBT data after patients stopped trial was not collected.||||||
2810772|NCT00445601|Secondary|Compare Qualitative and Quantitative Toxicities Between the Treatment Arms|Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug|Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)|All eligible patients who received instillation after TURBT and reported adverse events|||Participants|||Number
2810773|NCT00445601|Secondary|Rate of Progression to Muscle Invasive Disease at 4 Years|From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.|4 years|Intent-to-Treat Population|||percentage of patients with progression|||Number
2810774|NCT00445601|Primary|Disease Recurrence Rate|Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.|Up to 2 Years|Intent-to-Treat population|||percentage of patients with recurrence|||Number
2810775|NCT00445588|Secondary|6months -Progression-free Survival Rate|defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up|At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up||||percentage of participants||95% Confidence Interval|Number
2810776|NCT00445588|Primary|Overall Survival|death. measured by time of first day of treatment until date of death, assessed up to 2 years.|Time of first day of the treatment to death, assessed up to 2 years||||months||95% Confidence Interval|Median
2810777|NCT00445549|Secondary|The Number of Participants With Adverse Events|Here are the total # of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|22 months||||Participants|||Number
2810778|NCT00445549|Primary|Number of Participants With Clinical Efficacy|Defined as complete response (CR), partial response (PR), or disease stabilization lasting 6 months or longer per RECIST criteria. CR-total disappearance of all evaluable disease. PR->30% reduction in the sum of the longest diameters (LD) of target lesions. Stable disease (SD) is <30% decrease and <20% increase in the sum of the LD of all target lesions. See the protocol Link module for full RECIST criteria.|24 weeks||||participants|||Number
2810779|NCT00445484|Primary|23F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
2810780|NCT00445484|Primary|19F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
2810781|NCT00445484|Primary|14F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
2810782|NCT00445484|Primary|6B Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.|||fold change||Standard Error|Mean
2810783|NCT00445458|Secondary|Area Under the Concentration-time Curve 0-24|Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.|Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2810784|NCT00445458|Secondary|Maximum Plasma Concentration of Neratinib|Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.|Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2810785|NCT00445458|Primary|Objective Response Rate|Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to 140 weeks|All subjects, in Study part 2 evaluable population, who met the inclusion/exclusion criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 post-Baseline tumor assessment. Subjects who died or had symptomatic deterioration before the first scheduled post-Baseline tumor assessment were included.|||percentage of participants||95% Confidence Interval|Number
2810786|NCT00445458|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.|From first dose date through day 28.|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||mg|||Number
2810787|NCT00445458|Primary|Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel|Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.|From first dose date through day 28|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||Participants|||Count of Participants
2810788|NCT00445432|Other Pre-specified|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
2810789|NCT00445432|Other Pre-specified|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
2810790|NCT00445432|Other Pre-specified|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148|"IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms & their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life [e.g., feeling of fatigue all of the time]; 7=good quality [e.g., feeling of fatigue none of the time]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
2810791|NCT00445432|Other Pre-specified|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
2810792|NCT00445432|Other Pre-specified|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||units on a scale||Standard Deviation|Mean
2810793|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||participants|||Number
2811049|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2810794|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||participants|||Number
2810795|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Remission at Week 148|Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.|||participants|||Number
2810796|NCT00445432|Secondary|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
2810797|NCT00445432|Secondary|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
2810798|NCT00445432|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality (e.g., feeling of fatigue none of the time). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
2810799|NCT00445432|Secondary|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
2810800|NCT00445432|Secondary|Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of open-label treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug). Last observation carried forward (LOCF) used for missing data.|||Participants|||Number
2810813|NCT00445328|Primary|Confirmed Thromboembolic Events|Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.|Day 21|Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment.|||participants|||Number
2810801|NCT00445432|Secondary|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.|||units on a scale||Standard Deviation|Mean
2810802|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.|||Participants|||Number
2810803|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab [not placebo] during adalimumab induction study and who received >= 1 dose of DB study drug during this study). Nonresponder imputation (NRI) (CR-70 not achieved) used for DB treatments; LOCF for OL treatment.|||Participants|||Number
2810804|NCT00445432|Primary|Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.|||Participants|||Number
2810805|NCT00445341|Primary|Response Rate (Complete Response (CR) and Partial Response (PR))|Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (</= 1.5 cm in greatest diameter if > 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to </= 1 cm or by more than 75% in the sum of the products of the greatest diameters (SPD). Spleen, if considered to be enlarged before therapy, must have regressed in size. Partial response is a >/= 50% decrease in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >/= 50% in the SPD. Bone marrow is irrelevant for determination of a PR.|2/16/2007 - 1/20/2011||||Participants|||Count of Participants
2810806|NCT00445341|Primary|Number of Participants With Adverse Events (e.g. Toxicity)|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|47 months||||Participants|||Count of Participants
2810807|NCT00445328|Secondary|Thrombocytopenia|Subjects with thrombocytopenia (low platelets).|Day 21|Intent to Treat (ITT)|||participants|||Number
2810808|NCT00445328|Primary|Composite of Objectively Verified Thromboembolic Events|Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.|Day 21|Intent to treat (ITT)|||participants|||Number
2810809|NCT00445328|Secondary|Allergic Reactions (Drug-related)|Subjects with drug-related allergic reactions|Day 21|Intent to treat (ITT)|||participants|||Number
2810810|NCT00445328|Secondary|Bleeding - Major or Minor|Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.|Day 21|Intent to treat (ITT)|||participants|||Number
2810811|NCT00445328|Secondary|Stroke - Ischemic or Hemorrhagic|Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography|Day 21|Intent to treat (ITT)|||participants|||Number
2810812|NCT00445328|Secondary|All Cause Mortality|Subjects with death from any cause: end of study.|Day 14, Day 21 (End of Study)|Intent to treat (ITT)|||participants|||Number
2810815|NCT00445315|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8|HCV RNA levels were determined using the Abbott RealTime HCV polymerase chain reaction (PCR) assay (lower limit of detection [LOD] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening Day 0 and Day 1 pre-dose measurements. The plasma HCV RNA data was log10 transformed, and the change in log10 HCV RNA at Day 8 post-dose from baseline was calculated.|Baseline, Day 8|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.|||log10 copies/mL||Standard Deviation|Mean
2810816|NCT00445315|Primary|Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
2810817|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
2810818|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0)|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
2810819|NCT00445315|Primary|Renal Clearance (CLr): Day 8|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||mL/minute||Standard Deviation|Geometric Mean
2810820|NCT00445315|Primary|Renal Clearance (CLr): Day 1|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||mL/minute||Standard Deviation|Geometric Mean
2810821|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8|Percent of dose recovered unchanged in urine during the dosing interval=100 (cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||percent dose recovered||Standard Deviation|Geometric Mean
2810822|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1|Percent of dose recovered unchanged in urine during the dosing interval=100*(cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||percent dose recovered||Standard Deviation|Geometric Mean
2810823|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||nanogram||Standard Deviation|Geometric Mean
2810824|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.|||nanogram||Standard Deviation|Geometric Mean
2810825|NCT00445315|Primary|Observed Accumulation Ratio for Cmax (Rac Cmax)|Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
2811050|NCT00443729|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
2810826|NCT00445315|Primary|Observed Accumulation Ratio (Rac)|Rac was calculated as, area under the curve from time zero to end of dosing interval on Day 8 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1(AUCtau).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ratio||Standard Deviation|Geometric Mean
2810827|NCT00445315|Primary|Plasma Decay Half-Life (t1/2): Day 8|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. The t1/2 of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hour||Standard Deviation|Mean
2810828|NCT00445315|Primary|Minimum Observed Plasma Trough Concentration (Cmin): Day 8|The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2810829|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ng*hour/mL||Standard Deviation|Geometric Mean
2810830|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||ng*hour/mL||Standard Deviation|Geometric Mean
2810831|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||hour||Full Range|Median
2810832|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||hour||Full Range|Median
2810833|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2810834|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|Per Protocol (PP) analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the pharmacokinetics (PK) parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2810835|NCT00445302|Secondary|Number of Participants in Overall Safety Summary of Adverse Events (TEAE)|Number of participants with adverse events (AEs) collected from Day 1 (post plerixafor administration) to Day 3. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|up to Day 3|The safety analyses were performed on the Safety Population which consisted of all subjects who received plerixafor.|||participants|||Number
2810836|NCT00445302|Primary|Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)|Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population|||hr*ng/mL/ug||Standard Deviation|Mean
2810837|NCT00445302|Secondary|Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2|Change in absolute white blood cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = absolute white blood cells at 24 hours post dose - absolute white blood cells at Baseline.|Baseline and Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.|||cells/mm^3||Standard Deviation|Mean
2810838|NCT00445302|Secondary|Change From Baseline in Absolute CD34+ Cell Counts at Day 2|Change in circulating CD34+ cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = CD34+ cell count at 24 hours post dose - CD34+ cell count at Baseline.|Baseline, Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.|||cells/mm^3||Standard Deviation|Mean
2810839|NCT00445302|Primary|Dose-Normalized Maximum Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population|||ng/mL/ug||Standard Deviation|Mean
2810840|NCT00445263|Secondary|Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.||d30|||||||
2810841|NCT00445263|Secondary|Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus||d30|||||||
2810853|NCT00445211|Primary|Major Bleeding During the Index Hospitalization|Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death.|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients|||Participants|||Count of Participants
2810854|NCT00445211|Primary|Major Ischemia (Decreased Blood Flow) During the Index Hospitalization|Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis.|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients|||Participants|||Count of Participants
2810855|NCT00445211|Primary|Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization|Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function|0-4 days post surgery|Only 8 patients analyzed in Heparin group and 9 patients in non-Heparin group; data not available for remaining patients|||Participants|||Count of Participants
2810856|NCT00445146|Secondary|Incidence of Mortality|The percentage of participants who died was summarized.|Up to Week 408 plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2810857|NCT00445146|Secondary|CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed.|||cells/mm^3||Standard Deviation|Mean
2810858|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage of participants|||Number
2810859|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage of participants|||Number
2810860|NCT00445146|Secondary|HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2810861|NCT00445146|Secondary|Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||U/L||Standard Deviation|Mean
2810862|NCT00445146|Secondary|Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||U/L||Standard Deviation|Mean
2810863|NCT00445146|Secondary|Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||U/L||Standard Deviation|Mean
2810864|NCT00445146|Secondary|Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||10^3 cells/µL||Standard Deviation|Mean
2810865|NCT00445146|Secondary|White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||10^3 cells/μL||Standard Deviation|Mean
2810866|NCT00445146|Secondary|Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||10^6 cells/μL||Standard Deviation|Mean
2810867|NCT00445146|Secondary|Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.|||g/dL||Standard Deviation|Mean
2810868|NCT00445146|Secondary|Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality|A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.|||percentage of participants|||Number
2810869|NCT00445146|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.|||percentage of participants|||Number
2821798|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Post intervention||||units on a scale||Standard Deviation|Mean
2810872|NCT00445003|Secondary|Change in Optical Coherence Tomography Retinal Volume|Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively|Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||mm^3||Standard Deviation|Mean
2810873|NCT00445003|Secondary|Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema|Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.|14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Eyes|||Number
2810874|NCT00445003|Secondary|Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema||14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Eyes|||Number
2810875|NCT00445003|Secondary|Change in Visual Acuity From Baseline|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Letter Score||Standard Deviation|Mean
2810876|NCT00445003|Secondary|Total Optical Coherence Tomography Retinal Volume|Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.|Baseline to 14-weeks|Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.|||mm^3||Standard Deviation|Mean
2810877|NCT00445003|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness||Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.|||Microns||Inter-Quartile Range|Median
2810878|NCT00445003|Secondary|Additional Treatments for Diabetic Macular Edema|Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.|14 weeks to 56-weeks||||Eyes|||Number
2810879|NCT00445003|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 14 weeks|Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.|||Letter Score||Standard Deviation|Mean
2810880|NCT00444951|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination||Day 0 to Day 7 Post-vaccination|Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)|||Participants|||Number
2810881|NCT00444951|Secondary|Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination||Baseline (Day 0) and Day 28 After Vaccination|4-Fold rise titers were determined in the per-protocol population.|||Percentage of Participants|||Number
2810882|NCT00444951|Primary|Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination||Baseline (Day 0) and Day 28 after vaccination|Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2810883|NCT00444925|Post-Hoc|Diary Dry Rates|Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; only subjects with baseline urgency urinary incontinence >0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).|||participants|||Number
2810884|NCT00444925|Secondary|Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).|HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo, Tolterodine ER, and Fesoterodine, respectively.|||score on scale||Standard Error|Least Squares Mean
2810894|NCT00444925|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
2810885|NCT00444925|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.|||score on scale||Standard Error|Least Squares Mean
2810886|NCT00444925|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.|Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||participants|||Number
2810887|NCT00444925|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC).|Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||participants|||Number
2810888|NCT00444925|Secondary|Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.|Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||score on scale||Standard Error|Least Squares Mean
2810889|NCT00444925|Secondary|Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||score on scale||Standard Error|Least Squares Mean
2810890|NCT00444925|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.|Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
2810891|NCT00444925|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.|Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||severe urgency episodes per 24 hours||Standard Error|Least Squares Mean
2810892|NCT00444925|Secondary|Percent Change From Baseline of Urgency Episodes Per 24 Hours.|Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
2810893|NCT00444925|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.|Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||urgency episodes per 24 hours||Standard Error|Least Squares Mean
2810908|NCT00444912|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days from transplantation to PMN engraftment which was defined as PMN counts ≥0.5*10^9/L for 3 consecutive days or ≥1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PMN engraftment|||days||Full Range|Median
2810895|NCT00444925|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.|Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
2810896|NCT00444925|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours.|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
2810897|NCT00444925|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours.|The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||number of micturitions per 24 hours||Standard Error|Least Squares Mean
2810898|NCT00444925|Secondary|Change From Baseline in Mean Voided Volume Per Micturition.|Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||voided volume per micturition||Standard Error|Least Squares Mean
2810899|NCT00444925|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours.|UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||percent change||Full Range|Median
2810900|NCT00444925|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [Last Observation Carried Forward (LOCF)]) for placebo, Tolterodine ER, and Fesoterodine, respectively.|||number of episodes per 24 hours||Standard Error|Mean
2810901|NCT00444925|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.|Baseline, Week 12|Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still blinded.|||number of episodes per 24 hours||Standard Error|Mean
2810902|NCT00444912|Secondary|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Evaluable population of participants who received a stem cell transplant and had a 12-month assessment.|||participants|||Number
2810903|NCT00444912|Secondary|The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day||Day 5|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.|||percentage of total cells||Full Range|Median
2810904|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant||13 months (12 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 12 months post-transplant.|||cells / μL||Full Range|Median
2810905|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant||Approximately 7 months (6 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 6 months post-transplant.|||cells / μL||Full Range|Median
2810906|NCT00444912|Secondary|Median Number of Days to Lymphocyte Engraftment|Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5*10^8/L. Time to engraftment corresponded to the first day that criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had lymphocyte engraftment.|||days||Full Range|Median
2810907|NCT00444912|Secondary|Median Number of Days to Platelet (PLT) Engraftment|Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20*10^9/L without transfusion for the preceding 7 days or platelet counts ≥50*10^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PLT engraftment.|||days||Full Range|Median
2810913|NCT00444912|Primary|Summary of Adverse Events (AEs)|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.|Day 1 and up to Day 59 (maximum time before start of chemotherapy)|Safety Population: all participants who received at least 1 dose of study drug (G-CSF, plerixafor, or rituximab)|||participants|||Number
2810914|NCT00444821|Secondary|Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up|secondary interventions in those that had successful delivery and deployment by treatment group randomized to.|study termination|Study was terminated before all subjects enrolled and completed follow-up.|||Participants|||Count of Participants
2810915|NCT00444821|Secondary|Aneurysm Growth >0.5 cm|After repair, AAA enlargement by >0.5cm|1 year|Study was terminated before all subjects enrolled and completed follow-up.|||Participants|||Count of Participants
2810916|NCT00444821|Primary|Number of Subjects That Experienced Rupture or Aneurysm Related Death||3 years|Study was terminated before all subjects enrolled and completed follow-up.|||Participants|||Count of Participants
2810917|NCT00444795|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)|The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of study treatment, average of 23.2 weeks.|Intent-to-treat Analysis Set: Participants who administered Sutene at least once.|||Percentage of Participants||95% Confidence Interval|Number
2810918|NCT00444795|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|"An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as unlikely or no (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer."|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.|Safety Analysis Set|||Percentage of Participants||95% Confidence Interval|Number
2810919|NCT00444678|Secondary|Survival|Survival will be defined as the number of days from the first day of therapy to the date of death. If the subject is lost to follow-up, survival will be censored on the last date the subject was known to be alive.|6 months since the start of treatment and every 3 months after treatment for up to 10 years||||Days||Full Range|Median
2810920|NCT00444678|Secondary|Time to Progression|Time to Treatment Failure (progression or death) will be defined as the time from the first day of treatment until the date Progressive Disease (PD) or death is first reported. Subjects who die without a reported prior progression will be considered to have progressed on the day of their death. Subjects who did not progress will be censored at the day of their last tumor assessment.|6 months since the start of treatment and every 3 months after treatment for up to 10 years||||Days||Full Range|Median
2810921|NCT00444678|Secondary|Toxicity Rates|# of subjects who experienced >= grade 1 adverse event that is positively related to treatment.|1 year since the first treatment and every year after for up to 10 years||||Participants|||Count of Participants
2810922|NCT00444678|Primary|Response Rate for the Combination Treatment|The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.|6 months since the start of treatment||||Participants|||Count of Participants
2810923|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period|"Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|weeks 36 up to 47 weeks|Safety Population for repeat treatment.|||Participants|||Number
2810924|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period|"Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|Weeks 1-36|Number of patients randomized to initial treatment phase. Safety Population.|||Participants|||Number
2810925|NCT00444626|Secondary|Participant Product Preference at Week 36|Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Participants|||Number
2810927|NCT00444626|Secondary|Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24|Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Participants|||Number
2810928|NCT00444626|Secondary|Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36|"Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Units on a scale|Participants|Standard Deviation|Mean
2810929|NCT00444626|Secondary|Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)|The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).|Day 1|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Units on a scale||Standard Deviation|Mean
2810930|NCT00444626|Primary|Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24|"This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.|||Units on a scale|Participants|Standard Deviation|Mean
2810931|NCT00444600|Other Pre-specified|Major Ocular Adverse Events During First Year of Follow-Up||1 Year||||Eyes|Eyes||Number
2810932|NCT00444600|Secondary|Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year||from baseline to 1 Year||||mm^3|Eyes|Standard Deviation|Mean
2810933|NCT00444600|Secondary|Mean Optical Coherence Tomography Retinal Volume at 1 Year||1 Year||||mm^3|Eyes|Standard Deviation|Mean
2810934|NCT00444600|Other Pre-specified|Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year|Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause.|1 Year|Study participants with 2 study eyes are assigned to the non-sham group. Multiple events within a study participant are only counted once per event.|||Participants|||Number
2810935|NCT00444600|Secondary|Percentage of Eyes Receiving Laser at the 48 Week Visit (%)||1 Year||||Eyes|Eyes||Number
2810936|NCT00444600|Other Pre-specified|Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year|Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing.|from baseline to 1 Year||||Eyes|Eyes||Number
2810937|NCT00444600|Other Pre-specified|Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year|113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833|from baseline to 1 Year||||Eyes|Eyes||Number
2810938|NCT00444600|Other Pre-specified|Eyes With Alternative Treatments Prior to the 1-year Visit|Each combination of treatment only counted once.|1 Year||||Eyes|Eyes||Number
2810939|NCT00444600|Secondary|Number of Laser Treatments Received Prior to the 1 Year Visit|One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment.|1 Year|Number who completed the 1-year visit.|||Eyes|Eyes||Number
2810940|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters|Eyes|Standard Deviation|Mean
2810941|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters|eyes|Standard Deviation|Mean
2810942|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters|Eyes|Standard Deviation|Mean
2810943|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year||||Letters||Standard Deviation|Mean
2810944|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema||from baseline to 1 Year||||Letters||Standard Deviation|Mean
2810945|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline||from baseline to 1 Year||||Letters|Eyes|Standard Deviation|Mean
2810946|NCT00444600|Other Pre-specified|Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening|Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.|1 Year||||Eyes|Eyes||Number
2810947|NCT00444600|Other Pre-specified|Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year||1 Year||||Eyes|Eyes||Number
2810948|NCT00444600|Primary|Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis.|||Eyes|Eyes||Number
2810949|NCT00444600|Primary|Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. followed intention to treat principle.|||Letters|Eyes|Standard Deviation|Mean
2810950|NCT00444600|Secondary|Number of Injections in First Year|Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections.|from baseline to 1 year|Sham+prompt laser group listed median excludes 56 eyes among 163 participants with 2 study eyes that were unmasked at baseline because the participant's other eye was in the ranibizumab+deferred laser group, precluding sham injections for the study eye assigned to sham+prompt laser.|||Injections|Eyes|Inter-Quartile Range|Median
2810951|NCT00444600|Secondary|Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year|Negative change denotes an improvement.|from baseline to 1 year||||microns|Eyes|Standard Deviation|Mean
2810952|NCT00444587|Secondary|Mean Left Ventricular Ejection Fraction|Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||percent of blood pumped from LV chamber]||Standard Deviation|Mean
2810953|NCT00444587|Secondary|Hematology Safety Laboratory Parameter: Mean Platelets Counts|Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Number of cells x 10^9/L||Standard Deviation|Mean
2810954|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts|"Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments.~Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice."|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||percent of differential||Standard Deviation|Mean
2810955|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts|Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||10^9 leukocytes/L||Standard Deviation|Mean
2811051|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2810956|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels|Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||grams per deciliter||Standard Deviation|Mean
2810957|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels|Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Millimole per liter||Standard Deviation|Mean
2810958|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Albumin Levels|Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||gram per liter||Standard Deviation|Mean
2810959|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels|Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Micromole/liter||Standard Deviation|Mean
2810960|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels|Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.|||Units per liter||Standard Deviation|Mean
2810961|NCT00444587|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 5 years|The Safety Population included all participants who entered the trial and received at least one dose of trial medication.|||Number of participants|||Number
2810962|NCT00444587|Secondary|Overall Survival|Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants with data available were analyzed.|||Days||95% Confidence Interval|Median
2810963|NCT00444587|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants who experienced treatment failure were analyzed.|||Days||95% Confidence Interval|Median
2810964|NCT00444587|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR, PR and SD. Study design was changed to single arm study because herceptin use after progression herceptin-based therapy become widespread.|||Percentage of participants||95% Confidence Interval|Number
2811052|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2810965|NCT00444587|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR or PR|||Percentage of participants||95% Confidence Interval|Number
2810966|NCT00444587|Primary|Median Time to Disease Progression|Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. n = Numbers of participants included in this analysis.|||Days||95% Confidence Interval|Median
2810967|NCT00444535|Secondary|Progression-free Survival|Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population|||weeks||95% Confidence Interval|Median
2810968|NCT00444535|Secondary|Clinical Benefit|Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population|||Percentage of participants|||Number
2810969|NCT00444535|Secondary|Overall Response|The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.|Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population. Analysis was done on 45 of 52 participants, as 7 participants had withdrawn before Week 6.|||Percentage of participants|||Number
2810970|NCT00444535|Primary|Percentage of Participants Reaching Week 12 Without Disease Progression|The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).|Week 12|Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication|||Percentage of participants|||Number
2810971|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.|||percentage of participants|||Number
2810972|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
2810973|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
2821799|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Pre Intervention||||units on a scale||Standard Deviation|Mean
2810974|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
2810975|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.|||percentage of participants|||Number
2810976|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
2810977|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
2810978|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.|||percentage of participants|||Number
2810979|NCT00444457|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
2810980|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||observed percentage of participants||95% Confidence Interval|Number
2810981|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.|||observed percentage of participants||95% Confidence Interval|Number
2810993|NCT00444275|Secondary|Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)|Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)|4 to 16 weeks|871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data)|||Scores on scale||Standard Deviation|Mean
2810982|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||observed percentage of participants||95% Confidence Interval|Number
2810983|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.|||observed percentage of participants||95% Confidence Interval|Number
2810984|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.|||observed percentage of participants||95% Confidence Interval|Number
2810985|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.|||observed percentage of participants||95% Confidence Interval|Number
2810986|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.|||observed percentage of participants||95% Confidence Interval|Number
2810987|NCT00444457|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.|||GMC mcg/mL||95% Confidence Interval|Geometric Mean
2810988|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)|May be used to define the success of treatment. Not done|Week 4|The results of exploratory analyses are not available.||||||
2810989|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|"May be used to offer patients a strategy of treatment during the initial phase and in the long term.~Not done"|Day 0|The results of exploratory analyses are not available.||||||
2810990|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|May be used to evaluate the severity of symptoms during the initial visit. Not done|Day 0|The results of exploratory analyses are not available.||||||
2810991|NCT00444275|Secondary|Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study|Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.|12 weeks - maintenance treatment phase||||Participants|||Number
2810992|NCT00444275|Secondary|Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment|Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression)|16 weeks||||Percent of participants with failure|||Number
2810995|NCT00444275|Secondary|Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).|"Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator.~The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From Never for the Lowest Frequency to Every Day for the Highest, 6 Others Assess the Severity of Symptoms From Not at All to Strong. The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item."|4 weeks||||Percentage of participants|||Number
2810996|NCT00444275|Primary|Efficacy of Three Strategies of Long-term Treatment|Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?|16 weeks||||Percentage of participants with failure|||Number
2810997|NCT00444145|Primary|Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy|Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.|3 months||||participants|||Number
2810998|NCT00444106|Secondary|Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42|Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.|Days 14, 28 and 42|Full Analysis Set defined as all randomized patients with confirmed malaria at baseline, who had at least one dose of study drug and had at least one relevant post-baseline efficacy assessment.|||Percentage of Participants||95% Confidence Interval|Number
2810999|NCT00444106|Secondary|Relationship Between Changes in Auditory Function and Treatment Groups|ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.|From Baseline to Day 7||||ms||95% Confidence Interval|Mean
2811000|NCT00444106|Secondary|Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)|Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.|Baseline (Day 1), 3, 7, 28 and Day 42|Safety per protocol patients who had a valid ABR at baseline and on the specified day were included.|||dB||95% Confidence Interval|Mean
2811001|NCT00444106|Primary|Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)|"To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An auditory nerve abnormality is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups."|7 days|Safety per protocol set defined as all the randomized patients who took at least 80% of the entire recommended dose and had a valid baseline and Day 7 ABR Wave III latency evaluation and did not use any meds having an ototoxic effect.|||Percentage of Participants||95% Confidence Interval|Number
2811002|NCT00444067|Other Pre-specified|Incidence of Post-Operative Surgical Site Infections (SSIs)|"•Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis~SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space)."|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with SSIs between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.|||percentage of participants||95% Confidence Interval|Number
2811003|NCT00444067|Other Pre-specified|Incidence of Post-Operative CSF Leaks|"Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or~CSF leak confirmation by diagnostic testing within 90 days post-procedure; or~CSF leak confirmation by clinical evaluation within 90 days post-procedure"|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with CSF leaks between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.|||percentage of participants||95% Confidence Interval|Number
2811004|NCT00444067|Primary|Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)|"Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as:~A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds."|Intra-operative|The primary analysis for the primary efficacy endpoint was performed using a two-sided Fisher’s Exact Test to test for a difference in the true success rates in obtaining a watertight closure between treatments.|||percentage of participants||95% Confidence Interval|Number
2811053|NCT00443729|Primary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811054|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811005|NCT00444028|Primary|Dose Proportionality (AUCinf) by Power Analysis|"Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||hr*mcg/L||Standard Deviation|Mean
2811006|NCT00444028|Primary|Cmax|maximum concentration of loxapine observed|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||ng/mL||Standard Deviation|Mean
2811007|NCT00444028|Primary|Clearance|clearance (CL/F) of lozxapine|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||L/hour||Standard Deviation|Mean
2811008|NCT00444028|Primary|ke|elimination rate constant|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||/hour||Standard Error|Mean
2811009|NCT00444028|Primary|Half-life|Half-life of the terminal elimination phase of loxapine concentrations|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||hours||Standard Deviation|Mean
2811010|NCT00444028|Primary|Tmax|Tmax = time from inhalation to to maximum observed loxapine concentration|predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours|PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data|||minutes||Standard Deviation|Mean
2811011|NCT00443898|Secondary|Number of Participants Assessed With Adverse Events and Serious Adverse Events|"An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.~A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage."|52 weeks|Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population.|||Participants|||Number
2811012|NCT00443898|Secondary|Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.~Clinical effectiveness was a composite binary variable defined as Yes if~Mycological cure (negative KOH and negative culture for dermatophytes) and~= 10% residual involvement of the target toenail No if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).|||Percentage of Participants|||Number
2811013|NCT00443898|Secondary|Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.|"Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.~Mycological cure was a composite binary variable defined as Yesif :~Negative microscopy and~Negative culture for dermatophytes No if otherwise."|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).|||Percentage of Participants|||Number
2811014|NCT00443898|Primary|Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.|"Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.~and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as Yes if:~Mycological cure (negative KOH and negative culture for dermatophytes) and~No residual involvement of the target toenail No if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).|||Percentage of Participants|||Number
2811015|NCT00443872|Secondary|Mini Mental State Examination (MMSE) Scores for All Subjects|The MMSE is a general measure of cognition (i.e., measures attention, memory, visuospatial construction, etc). It has 30 items, each item representing 1 point. The total score ranges from 0-30 with 30 being a perfect score (no cognitive impairment) and 0 being the lowest score (greatest possible level of impairment). The total score is calculated by adding the scores of each item.|Baseline and 3 months|All|||units on a scale||Standard Deviation|Mean
2811016|NCT00443872|Secondary|Beck Anxiety Inventory Scores for All Subjects|The Beck Anxiety Inventory is a general measure of anxiety. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (severe - I could barely stand it), all questions are related to the presence of signs or symptoms of anxiety. The total possible score is 63 and a higher score represents greater anxiety. The total score is calculated by adding the responses for each of the 21 items.|Baseline and 3 months|All|||units on a scale||Standard Deviation|Mean
2811017|NCT00443872|Secondary|Beck Depression Inventory for All Subjects|The Beck Depression Inventory is a general measure of depression. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (maximum issue/distress), all questions are related to emotions, mood, feelings, etc. The total possible score is 63 (higher scores represent more depression). The total score is calculated by adding the scores of the 21 items.|Baseline and 3 months|All|||units on a scale||Standard Deviation|Mean
2811055|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811018|NCT00443872|Secondary|PDQ-39 Quality of Life Assessment Total Scores|The PDQ-39 is a measure of quality of life, it has 8 sub scales and a total score. For this study only the total score was examined. There are a total of 39 questions related to the following 8 sub scales: ability/difficulty to perform motor activities, ability to perform daily activities, cognition, emotional well being, stigma, social support, communication, bodily discomfort; each question with 5 responses (0, no/never, 4 always). The total score is calculated by adding the scores for each of the 39 items, dividing by 39 x 4 (maximum score for all 39 items) and then multiplying by 100 to get a percentage score ranging from 0-100 with 100 representing the most disability and greatest impact on quality of life.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2811019|NCT00443872|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Scores|"The UPDRS activities of daily living sub scale has 14 questions regarding the ability to perform daily activities like dressing, eating, etc. These questions are completed by the patient and each question has 5 responses ranging from 0 (no problems) to 4 (severe disability/cannot do). The total score for this sub scale is the sum of the scores for the 14 questions (higher scores represent greater disability), maximum score is 56.~The motor assessment is completed by the investigator. There are 14 questions evaluating motor function in various body parts, representing 27 individual items (i.e., some questions, such as rigidity, are rated for 5 different body parts, other questions, such as finger tapping, are rated on both the right and left sides, and other questions are rated individually). Each item has 5 responses, 0 being none/no disability and 4 being the most severe disability. The 27 items are summed (higher scores represent greater disability); maximum score is 108."|Baseline and 3 months|All subjects completing the study were included|||units on a scale||Standard Deviation|Mean
2811020|NCT00443872|Primary|Barratt Impulsiveness Scale Score for Those With Impulsive Behavior|This is a measure of impulsiveness. There are 30 questions regarding the presence of impulsive and non-impulsive behaviors each scored from 1 (rarely/never) to 4 (almost always/always). The total score reflects the sum of the 30 items. A higher score represents more impulsiveness.|Baseline and 3 months|The number with ICDs at baseline|||units on a scale||Standard Deviation|Mean
2811021|NCT00443872|Primary|Circumference of Lower Leg/Foot at Greatest Point of Swelling for Pedal Edema|The circumference of the lower leg/ankle with the greatest swelling was measured using a standard tape measure at baseline and 12 weeks for both the right and left ankles.|Baseline and 3 months|Presence of pedal edema at baseline|||centimeters||Standard Deviation|Mean
2811022|NCT00443872|Primary|Neuropsychiatric Inventory (NPI) Hallucinations Scale Score for Those With Hallucinations|Report of hallucinations with insight maintained based on the hallucinations questions of the Neuropsychiatric Inventory (NPI). The participant and their caregiver are asked a series of questions to determine if hallucinations are present. If present they rate the frequency of hallucinations on a scale of 1 (rarely, less than once a week) to 4, very often (once or more daily). They also rate the severity of the hallucinations, as mild (1 - present but harmless and cause little distress), moderate (2 - distressing and disruptive) or severe (3 - very disruptive, major source of behavioral disturbance, may need meds). The frequency and severity scores are multiplied (maximum score 12, with higher scores representing more distress/disability) for the total score.|Baseline and 3 months|Patients who reported hallucinations at baseline|||units on a scale||Standard Deviation|Mean
2811023|NCT00443872|Primary|Epworth Sleepiness Scale Score for Those With Daytime Sleepiness|This is a measure of daytime sleepiness. The test is a list of eight situations in which one rates their tendency to become sleepy on a scale of 0, no change of dozing to 3, high chance of dozing. The total score ranges fro 0-24, with higher values representing excessive sleepiness. A score of greater than 10 represents clinically significant sleepiness.|Baseline and 3 months|Based only on the number of patients with excessive daytime sleepiness at baseline|||units on a scale||Standard Deviation|Mean
2811024|NCT00443872|Primary|Percentage of Participants With Reduction in Adverse Events|The primary outcome measure was the reduction of daytime sleepiness, hallucinations, pedal edema, and impulse control disorders after a reduction of dopamine agonist dose with the addition of an monoamine oxidase (MAO)-B inhibitor (orally disintegrating selegiline). Percentages of participants with reduction in individual adverse events as well as reduction in any adverse events are reported.|3 Months|77 patients enrolled in the study and 60 completed. Each patient had to have at least one of the following DA related AEs, excessive daytime sleepiness, hallucinations, pedal edema or impulse control disorder (they could have more than one AE). 60 subjects were selected based on results of previous studies (discontinued patients were replaced).|||percentage of participants|||Number
2811025|NCT00443846|Primary|Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype|Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.|28 days after the second dose of MCC vaccine (approximately 20 weeks)|The population analyzed was randomized participants excluding those with protocol violations that may have interfered with the immunogenicity evaluation.|||Percentage of participants||95% Confidence Interval|Number
2811026|NCT00443820|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.|52 weeks|Safety Population|||Number of participants|||Number
2811027|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.~Clinical effectiveness was a composite binary variable defined as Yes if:~If mycological cure (negative KOH and negative culture for dermatophytes) and~= 10% residual involvement of the target toenail No if otherwise"|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)|||Percentage of participants|||Number
2811028|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)|||Percentage of participants|||Number
2811030|NCT00443781|Primary|Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)|For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of >=2 Numerical Rating Scale (NRS) points AND >33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.|Approximately 2 hours per subject|Subjects which underwent Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) consist of 1 population (N=50). Subjects which underwent either PD, F.A.D. or neither diagnostic test consist of a second population (all subjects enrolled, N=62). This is a diagnostic study. No imputation technique was used.|||discs|discs||Number
2811031|NCT00443755|Other Pre-specified|Change From Baseline in Fat-Free Mass (FFM)|FFM was measured using dual energy x-ray absorptiometry (DEXA) scans and is reported in kilograms (kg).|Baseline, 3 months|Per-protocol analysis|||kilograms||Standard Deviation|Mean
2811032|NCT00443755|Other Pre-specified|Change From Baseline in Body Fat|Body fat is reported as a percentage of body weight.|Baseline, 3 months|Per-protocol population|||percentage of body weight||Standard Deviation|Mean
2811033|NCT00443755|Other Pre-specified|Change From Baseline in Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat.|Baseline, 3 months|Per-protocol population|||kg/m^2||Standard Deviation|Mean
2811034|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Adiponectin|Adiponectin is an anti-inflammatory cytokine and is reported in milligrams per milliliter (mg/mL).|Baseline, 3 months|Per-protocol analysis|||mg/mL||Standard Deviation|Mean
2811035|NCT00443755|Secondary|Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α)|TNF-α is an inflammatory cytokine and is reported in picograms/milliliter (pg/mL).|Baseline, 3 month|Per-protocol analysis|||pg/mL||Standard Deviation|Mean
2811036|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP)|CRP is an inflammatory cytokine and is reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis|||mg/dL||Standard Deviation|Mean
2811037|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6)|IL-6 is an inflammatory cytokine and reported in picograms per deciliter (pg/dL).|Baseline, 3 months|Per protocol analysis|||pg/mL||Standard Deviation|Mean
2811038|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1)|PAI-1 was measured by enzyme-linked immunosorbent assay (Diagnostica Stago Inc., Parsippany, New Jersey) and reported in nanograms per milliliter (ng/mL).|Baseline, 3 months|Per-protocol analysis|||ng/mL||Standard Deviation|Mean
2811039|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Fibrinogen|Fibrinogen was measured by thrombin clotting rate assay (Beckman Coulter, Inc. Brea, California) and reported in milligrams/deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis|||mg/dL||Standard Deviation|Mean
2811040|NCT00443755|Secondary|Change From Baseline in Lipid Profile|Change in lipids were measured by the change from baseline to 3 months of triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). All were reported in milligrams/deciliter (mg/dL).|Baseline, 3 months||||mg/dL||Standard Deviation|Mean
2811041|NCT00443755|Secondary|Change From Baseline in Insulin Levels|Insulin levels in the blood were measured by immunoenzymatic assay and reported in micro International Units per milliliter (mcIU/mL).|Baseline, 3 months|Per-protocol analysis|||microIU/mL||Standard Deviation|Mean
2811042|NCT00443755|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|HbA1c is a measure of average blood sugar levels over the preceding 3 month period. HbA1c was measured by ion-exchange chromatography and reported as a percentage.|Baseline, 3 months|Per-protocol analysis|||percentage||Standard Deviation|Mean
2811043|NCT00443755|Secondary|Change From Baseline in Fasting Blood Glucose Level|Glucose (sugar) was measured in the blood and reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis|||mg/dL||Standard Deviation|Mean
2811044|NCT00443755|Primary|Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR)|Insulin sensitivity was measured the morning after an overnight fast during an in-patient stay in the Clinical Research Unit & was determined by the mean GIR necessary to maintain euglycemia during a hyperinsulinemic (1.5 mcIU/kg of FFM per minute)-euglycemic (85-95 mg/dL) clamp. The clamp is an 8 hour process where a hand vein is catheterized to collect blood samples and intravenous lines are used to infuse glucose, saline, insulin, phenylalanine and amino acid solutions at at pre-specified times/rates. The mean GIR was calculated as the rate per kilograms of fat-free mass (FFM) during 4 hours of steady-state (hours 4-8 of the 8 hour clamp) reported as micromols/kilogram of FFM per minute. The FFM was measured by dual-energy x-ray absorptiometry (DEXA) scan. Insulin was infused with 5% essential amino acid solution (3mL/kg of FFM/hour) to prevent the insulin-dependent decrease of amino acids during insulin infusion.|Baseline, 3 months|Per-protocol analysis|||micromols/kg of FFM/minute||Standard Deviation|Mean
2811045|NCT00443729|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
2811046|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811047|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811048|NCT00443729|Secondary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811056|NCT00443729|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811057|NCT00443729|Other Pre-specified|Number of Patients With Drug-related LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811058|NCT00443729|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811059|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811060|NCT00443729|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811061|NCT00443729|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811062|NCT00443729|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811063|NCT00443729|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811064|NCT00443729|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811065|NCT00443729|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||24 Weeks|Full analysis set; one patient was excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.|||Participants|||Number
2811066|NCT00443703|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
2811067|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811068|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811069|NCT00443703|Secondary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811070|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811071|NCT00443703|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Median
2811072|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811073|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811074|NCT00443703|Primary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811075|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis|||Percent Change||Standard Deviation|Mean
2811076|NCT00443703|Other Pre-specified|Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks|Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811077|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811078|NCT00443703|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811079|NCT00443703|Other Pre-specified|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811080|NCT00443703|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811081|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811082|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811083|NCT00443703|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811084|NCT00443703|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811085|NCT00443703|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811086|NCT00443703|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis|||participants|||Number
2811087|NCT00443703|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis|||Participants|||Number
2811088|NCT00443703|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||Week 24|Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.|||Participants|||Number
2811089|NCT00443651|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Change From Baseline at Weeks 24 and 48|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Units on a scale||Standard Deviation|Mean
2811090|NCT00443651|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good and Moderate Responses at Weeks 24 and 48|Improvement in the post-baseline DAS 28-ESR score from baseline was used to determine the EULAR responses of moderate response and good response. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. For a post-baseline score ≤ 3.2, an improvement > 0.6 to ≤ 1.2 was a moderate response and ≥ 1.2 a good response. For a post-baseline score > 3.2 to ≤ 5.1, an improvement > 0.6 was a moderate response. For a post-baseline score > 5.1, an improvement ≥ 1.2 was a moderate response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
2811091|NCT00443651|Secondary|Percentage of Patients Achieving Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS 28-ESR) Remission and DAS 28-ESR Low Disease Activity Scores at Weeks 24 and 48|DAS 28-ESR was calculated using counts of tender and swollen joints (28 joints, 28TJC and 28SJC), a patient assessment (PA) of disease activity (DA) in previous 24 hours on a visual analog scale (no DA to maximum DA), and ESR at the current visit, using the following formula: 0.56 × 28TJC + 0.28 × 28SJC + 0.70 × ln(ESR) + 0.014 × PADA. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. DAS28-ESR Remission was defined as a DAS 28-ESR score of < 2.6. DAS28-ESR Low Disease Activity was defined as a DAS28-ESR score of ≤ 3.2.|Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab). There were 401 patients in the rituximab 1000 mg and 176 patients in the 500 mg safety populations. n = number of patients with non-missing DAS28-ESR last observation carried forward scores at Weeks 24 and 48 in the safety populations.|||Percentage of participants|||Number
2811092|NCT00443651|Secondary|Percentage of Patients With an Improvement of 20%, 50%, and 70% in American College of Rheumatology (ACR) Scores (ACR20/50/70) From Baseline at Weeks 24 and 48|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
2811093|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the Second Course (Optional Retreatment) of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From start of the second course of rituximab treatment through Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
2811094|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) During or Within 24 Hours of Rituximab Infusions|The percentage of patients developing a SAE during or within 24 hours of a rituximab infusion is reported separately for each of the 2 infusions in the first course of treatment (Days 1 and 15) and the second course of treatment (optional retreatment during Weeks 24 to 40). See the Primary Outcome Measure for a definition of a SAE.|From start of rituximab treatment through 24 hours|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
2811095|NCT00443651|Primary|Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From first treatment with rituximab (Day 1) through Week 24|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).|||Percentage of participants|||Number
2811096|NCT00443599|Secondary|Neurodevelopmental Evaluation, Motor|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.|||Scores on a scale||Standard Deviation|Mean
2811097|NCT00443599|Secondary|Neurodevelopmental Evaluation, Language|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing was completed at greater than 18 months post eligibility.|||Scores on a scale||Standard Deviation|Mean
2811098|NCT00443599|Secondary|Neurodevelopmental Evaluation, Cognitive|"Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.~Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.~Higher values indicate better neurodevelopmental outcomes.~These three composite scores cannot be combined and are presented as separate scores in the literature."|Measured at one year of age.|Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.|||Scores on a scale||Standard Deviation|Mean
2811099|NCT00443599|Secondary|Nutritional Status|Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.|The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days.|Nutritional intake was tracked during the period of critical illness, as defined by the presence of an arterial catheter.|||Percent of total caloric intake||Inter-Quartile Range|Median
2811100|NCT00443599|Secondary|Endocrine Function|Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.|Measured during participant's ICU stay on Day 7.|Thyroid hormones were assayed only if the participant remained in the cardiac ICU and there was central venous or arterial access for blood sampling.|||ng/dL||Inter-Quartile Range|Median
2813859|NCT00425308|Secondary|Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12|Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population|||mL/min/1.73m²||Standard Deviation|Mean
2811101|NCT00443599|Secondary|Immune Function|Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.|Post-operative day 7.|Participants analyzed include those with adequate access for blood sampling, C-reactive protein (CRP) drawn on post-operative day 7 and successful processing and preparation of samples,|||mg/dL||Inter-Quartile Range|Median
2811102|NCT00443599|Secondary|Cardiac Function|Cardiac function is assessed by duration of vasoactive support.|The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
2811103|NCT00443599|Secondary|Mortality at 30 Days.|Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family.|Measured at 30 days.|This outcome was not measured for participants lost to follow-up at 30 days post cardiac surgery.|||Participants|||Number
2811104|NCT00443599|Secondary|Mortality at Hospital Discharge.|Mortality is assessed at hospital discharge and at 30 days.|Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit).||||Participants|||Number
2811105|NCT00443599|Secondary|Duration of Endotracheal Intubation|Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.|The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
2811106|NCT00443599|Secondary|Duration of Hospital Stay|Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge.|The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
2811107|NCT00443599|Secondary|Duration of ICU Stay|Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.|The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days.||||Days||Inter-Quartile Range|Median
2811108|NCT00443599|Secondary|Cardiac Index (CI)|Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry.|Day 2 (day after cardiopulmonary bypass surgery).|This outcome (using indirect calorimetry) was not available at the Michigan site, and not captured in Boston participants A) who had been extubated or were receiving only pressure support ventilation, B) without a properly placed catheter allowing for a true mixed venous sample or C) for whom equipment malfunction precluded an accurate measurement.|||liters/min/m^2||Inter-Quartile Range|Median
2811109|NCT00443599|Primary|Incidence of Nosocomial Infections in the Cardiac ICU|Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf.|Measured during participant's ICU stay, a median duration of 3 days.||||infections / 1000 pt days|||Number
2811110|NCT00443560|Secondary|Duration of Labor Analgesia|Time in minutes from initiation of labor analgesia until delivery of the infant|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis was per protocal|||minutes||Inter-Quartile Range|Median
2811111|NCT00443560|Secondary|Number of Participants With Breakthrough Pain in the First Stage of Labor|Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.|Supplemental analgesia in first stage of labor (<24 hours)|Analysis was per protocol|||participants|||Number
2811112|NCT00443560|Primary|Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor|At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.|Second stage of labor up to 3 hours|Analysis was per protocal|||participants|||Number
2811113|NCT00443547|Secondary|Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score|Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst|24 Months|The Total Population enrolled and treated includes 89 (1-Level), 88 (2-Level), 48 (3-Level), and 6 (4-Level). With each outcome measure, the actual Overall Number of Participants Analyzed will vary based on the actual number of participants who completed the specific assessment at the specific timepoint.|||units on a scale||Standard Deviation|Mean
2811114|NCT00443547|Primary|Radiographic Fusion|Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels|12 Months|Number of subjects present for the 12 month visit|||percentage of subjects|||Number
2811115|NCT00443547|Primary|Radiographic Fusion|Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels|24 Months|Number of subjects present for the 24 month visit|||percentage of subjects|||Number
2811116|NCT00443534|Other Pre-specified|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.||||||
2811117|NCT00443534|Other Pre-specified|Progression-Free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.||||||
2811118|NCT00443534|Other Pre-specified|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 2 months until death or up to 2 years after the last dose of study treatment|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.||||||
2811119|NCT00443534|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 after last dose of study treatment|Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.|||participants|||Number
2811120|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||participants|||Number
2811121|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||participants|||Number
2811122|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
2811123|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
2811124|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
2811125|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
2811126|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
2813860|NCT00425308|Secondary|Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.||Month 12|Intent to Treat (ITT) Population|||participants|||Number
2811127|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.|||mmHg||Standard Deviation|Mean
2811128|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
2811129|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
2811130|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
2811131|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward|||mmHg||Standard Deviation|Mean
2811132|NCT00443430|Secondary|Clinical Remission on Medication|6 months of clinical inactive disease|12 months or end of study|all participants receiving study medications|||participants|||Number
2811133|NCT00443430|Secondary|Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events||Over 12 months maximum study participation per subject|all participants that received study medications|||events|||Number
2811134|NCT00443430|Primary|Proportion of Participants Who Attain Inactive Disease by 6 Months||6 months after initiation of study intervention|all participants receiving study medications|||participants|||Number
2811135|NCT00443352|Primary|Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Number of participants for analysis was modified intention to treat - anyone who took at least one dose of duloxetine|||days||Standard Deviation|Mean
2811136|NCT00443261|Primary|Evaluate the Safety and Toxicity of Azacitidine (5-azacytidine, Vidaza®) and Cisplatin Combination|Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.|Weeks 1-12, 24, 36|The 1 patient enrolled in the study died after cycle 1 with rapidly progressing cancer. Therefore, no data to analyze for primary outcome measure.||||||
2811137|NCT00443209|Secondary|Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.|2 hours post-dose (Up to 18 months)|The Full Analysis Set (FAS) population consisted of all participants who were randomized and reported at least one treated migraine attack with at least one post-treatment efficacy evaluation.|||Percentage of Migraine Attacks||Standard Deviation|Mean
2811138|NCT00443209|Primary|Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change|Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2811139|NCT00443209|Primary|Percentage of Participants With At Least One Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2811199|NCT00442767|Primary|Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone|Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone|0 to 240 minutes post-dose||||mmol*L/min||Standard Error|Mean
2811140|NCT00443209|Primary|Percentage of Participants With At Least One Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2811141|NCT00443209|Primary|Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)|Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2811142|NCT00443118|Secondary|• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks|Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation|1 day of life and 30 days after birth|this is an analyisis among the subgroup of subjects <32 weeks GA. this is the population at risk of this outcome. It extremely unusual intracranial hemorrhage over 32 weeks GA.|||Participants|||Count of Participants
2811143|NCT00443118|Secondary|Days on CPAP||after birth and during hospitalization up to four weeks||||days||Standard Deviation|Mean
2811144|NCT00443118|Secondary|Days on Mechanical Ventilation||after delivery and before four weeks||||days||Standard Deviation|Mean
2811145|NCT00443118|Secondary|• Need for Mechanical Ventilation or CPAP||during hospitalization||||participants|||Number
2811146|NCT00443118|Secondary|Days on Oxygen||after birth and during hospitalization up to four weeks||||days||Standard Deviation|Mean
2811147|NCT00443118|Secondary|• Use of Oxygen Treatment Beyond the Delivery Room||during hospitalization||||participants/|||Number
2811148|NCT00443118|Secondary|• Incidence of Air Leaks|included pneumothorax and Pneumomediastinum|after birth and during hospitalization up to four weeks||||participants|||Number
2811149|NCT00443118|Secondary|• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)||first week of life||||participants|||Number
2811150|NCT00443118|Secondary|Apgar Scores at 1 and 5 Minutes|categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.|1-5 minutes of life||||participants|||Number
2811151|NCT00443118|Secondary|• Need for Chest Compression and/or Medications||after 2 minutes of life||||participants|||Number
2811152|NCT00443118|Secondary|• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.||after 2 minutes of life||||percentage of participants|||Number
2811153|NCT00443118|Secondary|• SpO2 Value at 2 Minutes of Life.||2 minutes of life|the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.|||percentage of oxygen saturation||Standard Deviation|Mean
2811154|NCT00443118|Secondary|Time the Newborn Takes to Reach a HR > 100 Bpm||2 minutes of life||||minutes||Inter-Quartile Range|Mean
2811155|NCT00443118|Primary|Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.||2 minutes of life|The analysis was performed by intention to treat|||percentage of participants|||Number
2811156|NCT00443053|Secondary|Number of Any Adjudicated Bleeding Events at Days 47 and 77|"The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated On-Treatment, defined as from randomization up to the last injection +4 days."|Days 47 (or last dose plus 4 days) and 77|As-Treated Population|||events|||Number
2811157|NCT00443053|Secondary|Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77|"Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated On-Treatment, defined as from randomization up to the last injection +4 days."|Days 47 (or last dose plus 4 days) and 77|As-Treated Population|||events|||Number
2811158|NCT00443053|Secondary|Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77|"Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated On-Treatment, defined as from randomization up to the last injection +4 days."|Days 47 (or last dose plus 4 days) and 77|As-Treated Population: randomized participants who received at least one dose of study treatment, as actually received|||events|||Number
2811159|NCT00443053|Secondary|Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77|The number of participants requiring surgery was measured.|Days 47 and 77|ITT Population|||participants|||Number
2811160|NCT00443053|Secondary|Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77|VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.|Days 47 and 77|ITT Population|||participants|||Number
2811161|NCT00443053|Secondary|Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 77|ITT Population|||participants|||Number
2811162|NCT00443053|Primary|Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 47|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
2811163|NCT00443040|Secondary|Laboratory Values|Changes in laboratory values.|Daily for 38 days|||||||
2811164|NCT00443040|Secondary|Adverse Events|Adverse events grouped by body system|Daily for 38 days|||||||
2811165|NCT00443040|Secondary|Post-operative Analgesic Use||Daily for 38 days|||||||
2811166|NCT00443040|Secondary|Nasogastric Tube Re-insertion|Proportion of subjects with nasogastric tube re-insertion|Daily for 38 days|||||||
2811167|NCT00443040|Primary|Time to Return of Upper and Lower GI Function|The time to first bowel movement or the time to tolerating solid food, whichever occurs later.|Daily for 38 days|As the study was terminated early due to poor enrollment (31 of a planned 114 subjects were randomized and evaluable), no formal efficacy analyses were conducted.|||hours||Standard Deviation|Mean
2811168|NCT00443040|Secondary|Pain Score||Daily for 38 days|||||||
2811169|NCT00443040|Secondary|Vomiting Score||Daily for 38 days|||||||
2811170|NCT00443040|Secondary|Nausea Score||Daily for 38 days|||||||
2811171|NCT00443040|Secondary|Time to Writing of Hospital Discharge Order||Daily for 38 days|||||||
2811172|NCT00443040|Secondary|Time to First Bowel Movement||Daily for 38 days|||||||
2811173|NCT00443040|Secondary|Time to First Passage of Flatus||Daily for 38 days|||||||
2811174|NCT00443040|Secondary|Time to Tolerating Solid Food|Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal|4 hours of ingesting a meal|||||||
2811175|NCT00442962|Secondary|Late Change in CD4 Count From Baseline|Change in CD4+ lymphocyte counts between week 48 study visit and baseline.|At week 48|Participants with a CD4+ lymphocyte cell count result from the week 48 study visit.|||cells/mm^3||Standard Deviation|Mean
2811176|NCT00442962|Secondary|Time to First Dose Modification|Time from starting study treatment to first dose/drug modification.|Throughout study|All enrolled participants who started study treatment.|||weeks||95% Confidence Interval|Number
2811177|NCT00442962|Secondary|Percentage of Participants With Late Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Week 48|Participants with ultra-sensitive (detectable to 50 copies/mL) plasma HIV-1 RNA result available from week 48 visit.|||percentage||95% Confidence Interval|Number
2811178|NCT00442962|Secondary|Early Changes in CD4 Count From Baseline|Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.|At weeks 0(baseline), 4, 8, 16, 24|Intent to treat (study treatment status and history ignored); missing measurements ignored.|||cells/mm^3||Standard Deviation|Mean
2811179|NCT00442962|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)||Throughout study|All enrolled participants included.|||weeks||95% Confidence Interval|Number
2811180|NCT00442962|Secondary|Time to Initial Virological Failure|Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.|Throughout study|All participants enrolled are included.|||weeks||95% Confidence Interval|Number
2811181|NCT00442962|Secondary|Time to Initial Virologic Response|Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.|Throughout study|All enrolled participants included.|||weeks||95% Confidence Interval|Number
2811182|NCT00442962|Secondary|Percentage of Participants With Late Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 48|Participants with plasma HIV-1 RNA viral load result available from week 48 study visit.|||percentage||95% Confidence Interval|Number
2811183|NCT00442962|Secondary|Percentage of Participants With Early Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Weeks 24|ITT (ignoring current study treatment status and history); missing values ignored and closest value to week 24 used if multiple results available. 2 fewer results available compared to primary outcome b/c testing by ultrasensitive assay may have been retrospective.|||percentage of participants||95% Confidence Interval|Number
2811184|NCT00442962|Secondary|Time to First Safety Event|Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study|All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.)|||weeks||95% Confidence Interval|Number
2811185|NCT00442962|Primary|Percentage of Participants With Early Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 24|Intention to treat (ignoring current study treatment status or history); closest measurement to week 24 used; missing measurements ignored. Exact binomial confidence interval calculated using method of Blyth-Still-Casella.|||percentage of participants||95% Confidence Interval|Number
2811186|NCT00442936|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.|Up to 48 hours after first dose of study drug|The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.|||Participants|||Number
2811187|NCT00442936|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.|Up to 14 days after last dose of study drug|The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.|||Participants|||Number
2811188|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose|TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose.|||Participants|||Number
2811189|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose.|||Participants|||Number
2811190|NCT00442936|Secondary|Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose|SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose.|||Participants|||Number
2811191|NCT00442936|Primary|Number of Participants With Absence of Nausea at 2 Hours Post-Dose|Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose.|||Participants|||Number
2811192|NCT00442936|Primary|Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.|||Participants|||Number
2811193|NCT00442936|Primary|Number of Participants With Absence of Photophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.|||Participants|||Number
2811194|NCT00442936|Primary|Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.|||Participants|||Number
2811195|NCT00442936|Primary|Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.|||Participants|||Number
2811196|NCT00442897|Secondary|Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment|If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.|After 12 weeks of the treatment|All patient treated (APT) approach|||Participants|||Number
2811197|NCT00442897|Primary|Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment|Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)|After 6 weeks of treatment|The analysis used all patient treated (APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.|||Participants|||Number
2811198|NCT00442767|Secondary|Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.|Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone|0 to 120 minutes post-dose||||ng*L/min||Standard Error|Mean
2811220|NCT00442598|Primary|CA 125 Response Rate|Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.|Duration of study, up to 18 weeks.||||participants|||Number
2811200|NCT00442702|Secondary|Participants With Adverse Events|Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.|Randomization to Month 10 (final visit)|Safety population|||participants|||Number
2811201|NCT00442702|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions|Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.|From randomization to Month 9|Safety population included all randomized patients who received at least one dose of trial medication and a safety follow-up, according to the treatment received.|||participants|||Number
2811202|NCT00442702|Secondary|Change in Hemoglobin Concentration From Baseline Over Time||From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.|"Intent-to-treat population, including all randomized patients. n refers to the number of patients for whom data was available at each time point."|||g/dL||Standard Deviation|Mean
2811203|NCT00442702|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period|A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).|Per Protocol population consisted of all randomized patients who had received at least one dose of trial medication and who have no major protocol violation. Data missing at the end of the evaluation period were handled using the last observation carried forward method (LOCF).|||g/dL||Standard Deviation|Mean
2811204|NCT00442689|Primary|Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period|Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)|6 months||||L/min||Standard Deviation|Mean
2811205|NCT00442689|Primary|Change in Resting Energy Expenditure (REE) Over the Study Period|Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)|6 months||||Kcal/day||Standard Deviation|Mean
2811206|NCT00442689|Primary|Change in Disposition Index|Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)|6 months||||min^-1||Standard Deviation|Mean
2811207|NCT00442689|Primary|Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period|Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)|6 months||||percentage of body mass||Standard Deviation|Mean
2811208|NCT00442689|Primary|Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI|Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)|6 months||||L||Standard Deviation|Mean
2811209|NCT00442689|Primary|Change in High-density Lipoprotein (HDL) Levels During Study Period|Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)|6 months||||mg/dL||Standard Deviation|Mean
2811210|NCT00442689|Primary|Change in Low-density Lipoprotein (LDL) Levels Over the Study Period|Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)|6 months||||mg/dL||Standard Deviation|Mean
2811211|NCT00442611|Secondary|Change in Scleroderma Health Assessment Questionnaire|"The HAQ Disability Index (HAQ-DI) includes 20 items in 8 functional domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) assessing the patient's usual abilities in the past seven days. Each item is scored on a 0-3 scale (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=unable to do). The use of assistive devices for any domain increases the domain score by 1 point to a maximum of 3. The overall score is calculated by summing the highest item score in each of the domains and dividing the sum by 8, with an overall score of 0 indicating no disability, and a score of 3 indicating severe disability.~The time points compared were 6 months to baseline (6 months minus baseline)."|6 months|Participants with available data were analyzed.|||HAQ-DI score||Standard Deviation|Mean
2811212|NCT00442611|Secondary|Change in Pulmonary Function Tests|FVC (Forced Vital Capacity) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. DLCO (Diffusing capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the lungs to the blood.|6 months|Participants with available data were analyzed.|||% Predicted||Standard Deviation|Mean
2811213|NCT00442611|Secondary|Digital Ulcerations at Baseline and Month 6||Baseline; Month 6||||ulcers||Standard Deviation|Mean
2811214|NCT00442611|Secondary|Hand Extension at Baseline and Month 6||Baseline; Month 6||||mm||Standard Deviation|Mean
2811215|NCT00442611|Secondary|Oral Aperture at Baseline and Month 6||Baseline; Month 6||||mm||Standard Deviation|Mean
2811216|NCT00442611|Primary|Change in Modified Rodnan Skin Score|Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome).|6 months||||MRSS score||Standard Deviation|Mean
2811217|NCT00442598|Secondary|Overall Survival|Time from initiation of study drug to death.|Median measured in months, until death or censorship at analysis.||||months||Full Range|Median
2811218|NCT00442598|Secondary|Progression-free Survival|Time from initiation of study drug to disease progression or death on study|Median measured in months||||months||Full Range|Median
2811219|NCT00442598|Secondary|Objective Response Rate|Objective response rate measured by RECIST v1.0|Duration of study, up to 18 weeks.||||participants|||Number
2811221|NCT00442572|Secondary|Mean Change From Baseline in Triiodothyronine and Thyroxine|The Triiodothyronine (T3) and thyroxine (T4) values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||picomole/liter||Standard Deviation|Mean
2811222|NCT00442572|Secondary|Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)|The TSH was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||milli-international units/liter||Standard Deviation|Mean
2811223|NCT00442572|Secondary|Mean Change From Baseline in Blood Glucose|The blood glucose was measured for change from baseline. All blood glucose values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||millimoles/ liter||Standard Deviation|Mean
2811224|NCT00442572|Secondary|Mean Change From Baseline in Creatinine and Uric Acid|The creatinine and uric acid values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||micromole/liter||Standard Deviation|Mean
2811225|NCT00442572|Secondary|Mean Change From Baseline in Blood Urea|The blood urea was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||millimoles/liter||Standard Deviation|Mean
2811226|NCT00442572|Secondary|Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct|The laboratory parameters included bilirubin indirect and bilirubin direct. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||milligrams/deciliter||Standard Deviation|Mean
2811227|NCT00442572|Secondary|Mean Change From Baseline in Protein and Indirect Albumin|The clinical chemistry parameters included indirect protein and albumin. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and no intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Gram/deciliter||Standard Deviation|Mean
2811228|NCT00442572|Secondary|Mean Change From Baseline in Clinical Chemistry|The clinical chemistry parameters included alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP). All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Units/Litre||Standard Deviation|Mean
2811229|NCT00442572|Secondary|Mean Change From Baseline in Hematology|The hematology parameters included erythrocytes, leucocytes, basophils, eosinophils, lymphocytes, monocytes, thrombocytes. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||10^9/L||Standard Deviation|Mean
2811230|NCT00442572|Secondary|Mean Change From Baseline in Hemoglobin|The hemoglobin values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Gram/deciliter||Standard Deviation|Mean
2811231|NCT00442572|Secondary|Mean Change From Baseline in HBsAg Levels|An early decrease in HBsAg from baseline to Weeks 12 or 24 has been identified as further on-treatment predictor for sustained HBsAg clearance and virological response in HBeAg negative participants.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis.|||copies/mL||95% Confidence Interval|Mean
2811232|NCT00442572|Secondary|Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis|Fibrosis-4 (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) are non-invasive scoring systems, which are calculated on the basis of laboratory tests that indicates the level of liver fibrosis. The APRI scores are calculated based on Aspartate Aminotransferase (AST) levels and platelet counts whereas FIB-4 scores are calculated based on platelets, ALT, AST and age. For APRI, the scores are interpreted as ≤ 0.5 is 81% sensitive and 50% specific for a diagnosis of significant fibrosis in chronic hepatitis C (CHC), where as a cut-off > 1.5 is 35% sensitive and 91% specific for the diagnosis of significant fibrosis. The majority of biomarker panels will produce inconclusive results for a proportion of participants falling within the indeterminate range (between 0.5 and 1.5) for a specific fibrosis end-point. For FIB-4, the scores are interpreted as FIB-4 score of < 1.45: absence of cirrhosis, FIB-4 score of 1.45 to 3.25: inconclusive, FIB-4 score > 3.25: cirrhosis.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Units on a scale||Full Range|Median
2811233|NCT00442572|Secondary|Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity|HBV DNA level, or viral load, is an indicator of viral replication. Higher HBV DNA levels are usually associated with an increased risk of liver disease and hepatocellular carcinoma. HBV DNA level typically falls in response to effective antiviral treatment.|Up to Week 108|Safety population included all randomized participants who passed during at least one treatment period and had at least one efficacy and safety evaluation. HBV DNA levels below lower limit for significant quantity were not studied for no intervention arm participants.|||Percentage of Participants||95% Confidence Interval|Number
2811234|NCT00442572|Secondary|Percentage of Participants With HBsAg Seroconversion|"The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection. НBsAg seroconversion is the final goal of anti-hepatitis B virus treatment and it is closest to the definition of cure but in practice it is very rare in HBeAg-negative chronic hepatitis B (CHB)."|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis. Only participants with HBsAg clearance were analyzed.|||Percentage of Participants|||Number
2811235|NCT00442572|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Percentage of Participants||95% Confidence Interval|Number
2811236|NCT00442572|Secondary|Percentage of Participants With Stable Virological and Biochemical Response|All participants who achieved virological response (serum HBV DNA < 20 000 copies/ml) and biochemical response (stable normalization of their alanine transaminase [ALT]) during the treatment cycle (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Percentage of Participants||95% Confidence Interval|Number
2811237|NCT00442572|Primary|Percentage of Participants With Stable Virological Response|Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) <20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.|||Percentage of Participants||95% Confidence Interval|Number
2811238|NCT00442559|Secondary|Change From Baseline for Daily Allergic Rhinitis Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included.|||Units on scale||Standard Deviation|Mean
2811239|NCT00442559|Primary|Change From Baseline for Daytime Asthma Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.|||Units on scale||Standard Deviation|Mean
2811240|NCT00442546|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Month 3, Month 6 (phone call)|MITT|||scores on a scale||Standard Deviation|Mean
2811241|NCT00442546|Secondary|Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)|"The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes."|Month 3, Month 6 (phone call)|MITT|||participants|||Number
2811242|NCT00442546|Secondary|Number of Subjects With Global Evaluation of Study Medication Scores|The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).|Discharge, Week 2, Week 4, and Week 6/ET|MITT|||participants|||Number
2811243|NCT00442546|Secondary|Overall Pain Relief Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811244|NCT00442546|Secondary|Overall Satisfaction Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
2811245|NCT00442546|Secondary|Satisfaction With Medication Efficacy Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
2811246|NCT00442546|Secondary|Satisfaction With Medication Characteristics Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
2813861|NCT00425308|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.||Month 6 and 12|Intent to Treat Population|||participants|||Number
2811247|NCT00442546|Secondary|Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
2811248|NCT00442546|Secondary|Time From End of Surgery to Actual Discharge|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT|||hours||Standard Error|Mean
2811249|NCT00442546|Secondary|Time From End of Surgery to Meet Hospital Discharge Criteria|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT|||hours||Standard Error|Mean
2811250|NCT00442546|Secondary|ROM Assessment of the Passive Flexion of the Surgical Knee|The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||degrees||Standard Error|Least Squares Mean
2811251|NCT00442546|Secondary|Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee|The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||degrees||Standard Error|Least Squares Mean
2811252|NCT00442546|Secondary|Timed Up-and-Go (TUG)|TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 120 (Pregabalin 300 mg only), 144, 168, and 192 hours to calculate least squares mean values.|||seconds||Standard Error|Least Squares Mean
2811253|NCT00442546|Secondary|Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery|VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety.|Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery|MITT. There were not enough subjects with data at 6 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
2811254|NCT00442546|Secondary|Pain-Related Sleep Interference Post Surgery|The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge.|24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
2811255|NCT00442546|Secondary|Current Pain During the Hospital Stay Assessed by the Pain NRS|"Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain)."|4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay|MITT. There were not enough subjects with data at 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
2811256|NCT00442546|Secondary|Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS|Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
2811257|NCT00442546|Secondary|Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)|Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.|||scores on a scale||Standard Error|Least Squares Mean
2811258|NCT00442546|Secondary|Pain Interference With Sleep as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811259|NCT00442546|Secondary|Pain Interference With Normal Work as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811260|NCT00442546|Secondary|Pain Interference With Walking Ability as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811273|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|||||||
2811261|NCT00442546|Secondary|Pain Interference With Mood as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811262|NCT00442546|Secondary|Pain Interference With General Activity as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811263|NCT00442546|Secondary|Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811264|NCT00442546|Secondary|Pain Interference With Relations With People as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811265|NCT00442546|Secondary|Pain Interference Index Score as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811266|NCT00442546|Secondary|Total Clinically Meaningful Event (CME) Score|CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
2811267|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score|The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811268|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score|The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811269|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score|The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT|||scores on a scale||Standard Error|Least Squares Mean
2811270|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score|The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT.|||scores on a scale||Standard Error|Least Squares Mean
2811271|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT||||||
2811272|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT|||mg||Standard Error|Least Squares Mean
2811274|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|MITT|||mg||Full Range|Median
2811275|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 for Ibuprofen to calculate least squares mean values.||||||
2811276|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 and Week 4 for Ibuprofen to calculate least squares mean values.|||mg||Standard Error|Least Squares Mean
2811277|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT.|||mg||Standard Error|Least Squares Mean
2811278|NCT00442546|Secondary|Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)|Total dose for in-hospital visits was the total dose for the day.|24 hours, 48 hours, 72 hours|MITT. There were not enough subjects with data to calculate least squares mean values at 24 and 48 hours for Acetylalicyclic Acid and 72 hours for Ketorolac.|||mg||Standard Error|Least Squares Mean
2811279|NCT00442546|Secondary|Opioids Used Post Discharge|The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid.|Week 2, Week 4, Week 6/Early Termination (ET)|MITT|||mg of oral morphine equivalent||Standard Error|Least Squares Mean
2811280|NCT00442546|Secondary|Cumulative Total Amount of Opioids Used During the Entire Hospital Stay|Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours|MITT. There were not enough subjects with data at 168, 192, and 216 hours to calculate least squares mean values.|||mg of oral morphine equivalent||Standard Error|Least Squares Mean
2811281|NCT00442546|Primary|Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block."|48 hours after surgery|Modified Intent-to-Treat (MITT) Population=all ITT subjects who took 12 and 2 hours pre-surgery study medications, had no surgical or anesthetic complications during total knee replacement surgery and had at least 1 post surgery primary efficacy measurement.|||scores on a scale||Standard Error|Least Squares Mean
2811282|NCT00442507|Secondary|Incidence and Severity of Toxicities|Grade 3 and higher toxicities using CTCAE Version 3.0.|Median follow-up time for toxicities 72 days (72 days-156 days)|Details of all SAEs and AEs are listed in the Serious Adverse Events and Other Adverse Events modules.|||participants|||Number
2811283|NCT00442507|Secondary|Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)|"CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD."|Median follow-up for response 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.|||participants|||Number
2811284|NCT00442507|Secondary|Overall Survival Rate (OS)|OS is defined as the time from initiation of treatment to the date of death for any reason.|Median followup time from completion of treatment 325.5 days (44-401 days)||||months||95% Confidence Interval|Median
2811285|NCT00442507|Primary|Time to Progression (TTP)|"TTP is defined as the time from initiation of treatment to the date of documented progression.~The median of TTP with 95% confidence interval will be presented.~Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.~Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions."|Median follow-up for TTP 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.|||months||95% Confidence Interval|Median
2811286|NCT00442468|Secondary|"Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History"|IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.|Day 1 of 1-day study|All participant respondents to the questions|||participants|||Number
2811287|NCT00442468|Secondary|Number of Participants With the Indicated Experience With Tobacco Smoking||Day 1 of 1-day study|All participant respondents to the questions|||participants|||Number
2811288|NCT00442468|Secondary|Number of Participants Who Completed the Highest Indicated Education Level or Grade||Day 1 of 1-day study|All participant respondents to the questions|||participants|||Number
2811289|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status"||Day 1 of a 1-day study|All participant respondents to the questions|||participants|||Number
2811291|NCT00442468|Secondary|Post-bronchodilator Reversibility Measures|To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry|||participants|||Number
2811292|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures|"Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry|||percentage||Standard Deviation|Mean
2811293|NCT00442468|Secondary|FEV1 and FVC, Post-bronchodilator Spirometry Measures|Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day visit|All participants who completed post-bronchodilator spirometry|||Liters||Standard Deviation|Mean
2811294|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures|"Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry|||percentage||Standard Deviation|Mean
2811295|NCT00442468|Secondary|FEV1 and FVC, Pre-bronchodilator Spirometry Measures|Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry|||Liters (L)||Standard Deviation|Mean
2811296|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811297|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811298|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811299|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811300|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811322|NCT00442416|Secondary|Mean Change From Baseline in Iron|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.|From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||micromole per litre||Standard Deviation|Mean
2811301|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811302|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811303|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811304|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811305|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811306|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811307|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question|||participants|||Number
2811308|NCT00442468|Secondary|Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire|The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).|Day 1 of 1-day study|All study participants who completed the questionnaire|||participants|||Number
2811309|NCT00442468|Secondary|Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale|The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.|Day 1 of a 1-day study|All enrolled participants who completed the questionnaire|||participants|||Number
2811337|NCT00442169|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.||Days 0, 14, and 28 post-vaccination|Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2813862|NCT00425308|Secondary|Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12||From Baseline to Month 3, 6, and 12|Intent to Treat Population|||µmol/L||Standard Deviation|Mean
2811310|NCT00442468|Primary|Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%|Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).|Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)|All enrolled participants who completed pre- and post-bronchodilator spirometry|||participants|||Number
2811311|NCT00442416|Secondary|Number of Participants With Any AEs, Any Serious Adverse Events and Death|An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.|Up to 9 months|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2811312|NCT00442416|Secondary|Number of Participants With Anti-RO0503821 Antibody in Human Serum|"RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were BLQ at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported."|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2811313|NCT00442416|Secondary|Number of Participants With Anti-erythropoietin Antibody in Human Serum|"Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were below the limit of quantification (BLQ) at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported."|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2811314|NCT00442416|Secondary|Mean Change From Baseline in Weight||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||kilogram||Standard Deviation|Mean
2811315|NCT00442416|Secondary|Mean Change From Baseline in Pulse Rate||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||Beats per minute||Standard Deviation|Mean
2811316|NCT00442416|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||millimeter of mercury||Standard Deviation|Mean
2811317|NCT00442416|Secondary|Mean Change From Baseline in Temperature||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||Degree Celsius||Standard Deviation|Mean
2811318|NCT00442416|Secondary|Mean Change From Baseline in Total Iron-binding Capacity|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||mg per dL||Standard Deviation|Mean
2811319|NCT00442416|Secondary|Mean Change From Baseline in Serum Transferrin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||milligram (mg) per dL||Standard Deviation|Mean
2811320|NCT00442416|Secondary|Mean Change From Baseline in Transferrin Saturation|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
2811321|NCT00442416|Secondary|Mean Change From Baseline in Ferritin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.|||microgram per litre||Standard Deviation|Mean
2811338|NCT00442169|Primary|Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).|Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples|Day 28 post-vaccination|Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population|||Participants|||Number
2811323|NCT00442416|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as ‘n’.|||Participants|||Number
2811324|NCT00442416|Secondary|Percentage of Participants With Safety-Related Hb Measures|Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.|||Percentage of participants|||Number
2811325|NCT00442416|Primary|Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period|Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.|From Baseline (D 0) to 9 months|Per-protocol population included all randomized participants who received at least one dose of the study drug and met all study entry criteria with no major protocol violations. Participants with available data at the time of evaluation were analyzed.|||g/dL||Standard Deviation|Mean
2811326|NCT00442364|Primary|Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects||28 day followup||||participants|||Number
2811327|NCT00442351|Primary|Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.|The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.|Twelve (12) weeks|||||||
2811328|NCT00442338|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration|The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.|Baseline and 60 minutes after study drug administration|Per Protocol Set (PPS): subset of participants who comply with the protocol sufficiently to ensure that these data will likely exhibit effects of treatment, according to the underlying scientific model. Aminophylline 250 mg - 1 participant with no FEV1 data at 60 minutes was excluded from the analysis.|||Liter||95% Confidence Interval|Least Squares Mean
2811329|NCT00442286|Primary|Therapy-related Adverse Event-free Rate.|Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) therapy-related adverse event-free rates via a double-blind, randomized, parallel group, non-inferiority design for therapy-related serious adverse events occurring between 30 days post-implant and the Month 6 visit. The non-inferiority margin was 15%.|6 months post-activation||||percentage of participants||95% Confidence Interval|Number
2811330|NCT00442286|Primary|Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.|"Compare the event-free rate for all major hypertension-related and serious device-related adverse events occurring between 30 days post-implant and the Month 12 visit, to a pre-specified objective performance criterion of 72% based on similar implantable devices such as defibrillators and resynchronization devices.~Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort."|12 months-post activation||||percentage of participants||95% Confidence Interval|Number
2811331|NCT00442286|Primary|Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients|"Compare the serious procedure- or system-related adverse event-free rate for events occurring within 30 days of implant to a pre-specified objective performance criterion of 82% set based on historical literature on implantable cardioverter defibrillators (ICD) and pacemakers.~Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort."|30 days post implant||||percentage of participants||95% Confidence Interval|Number
2811332|NCT00442286|Primary|Percent of Group A (Rheos® Device On) Patients Who Maintain a 10 mm Hg Drop in Systolic Blood Pressure at 12 Months Post-activation, and Whose Response at 12 Months is at Least 50% of the Response Observed at 6 Months Post-activation.|Compare the sustained response in SBP Month 12 in Group A ( Rheos® Device On ) responders at Month 6 to an objective performance criterion of 65%. A sustained response to therapy required the reduction from Month 0 to Month 12 to be at least 10 mmHg and to remain at least 50% of that seen at Month 6.|12 months post-activation||||percentage of participants||97.5% Confidence Interval|Number
2811333|NCT00442286|Primary|Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure|Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.|6 months post-activation||||percentage of participants||95% Confidence Interval|Number
2811334|NCT00442169|Primary|Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.||Days 0 to 28 post-vaccination|Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.|||Participants|||Number
2811335|NCT00442169|Primary|Number of Viremic Participants Post-vaccination|Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL|Day 21 post-vaccination|Viremia was assessed in all participants in the safety population according to the vaccine actually received.|||Participants|||Number
2811336|NCT00442169|Other Pre-specified|Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population||Days 14 and 28 post-vaccination|Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population|||Participants|||Number
2811339|NCT00442117|Secondary|Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.|The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information. Two participants in the MF-DPI group and three participants in the BUD-DPI group were excluded from the analysis.|||Percent Change of AM PEFR||Standard Deviation|Mean
2811340|NCT00442117|Secondary|Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.|The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.|||Percent Change of FEF||Standard Deviation|Mean
2811341|NCT00442117|Secondary|Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.|The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.|||Percent Change of FVC||Standard Deviation|Mean
2811342|NCT00442117|Primary|Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.|FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.|||Percent Change of FEV1||Standard Deviation|Mean
2811343|NCT00442013|Secondary|Airways Reactivity (Assessed by Methacholine PC20)|Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds|Measured at Weeks 0 and 24||||mg/mL||95% Confidence Interval|Mean
2811344|NCT00442013|Secondary|Asthma Symptom Utility Index (ASUI)|ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24||||score||95% Confidence Interval|Mean
2811345|NCT00442013|Secondary|Rate of Episodes of Poor Asthma Control (EPAC)|"Episodes of poor asthma control are defined as any one of the following:~2 consecutive days with peak flow at less than 70% of baseline~prescription of oral corticosteroids for asthma~seeking urgent medical care for asthma symptoms~EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks"|Measured daily for 24 weeks by diary|The number of episodes of poor asthma control that occurred in each group over the 24-week follow-up period. Some participants experienced more than one EPAC over the course of follow-up|||number of episodes of poor asthma contrl|||Number
2811346|NCT00442013|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24||||Liters||95% Confidence Interval|Mean
2811347|NCT00442013|Secondary|Asthma-specific Quality of Life|Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24||||score||95% Confidence Interval|Mean
2811348|NCT00442013|Primary|Change in Juniper Asthma Control Score (ACS)|Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 24||||score||95% Confidence Interval|Mean
2811349|NCT00441974|Secondary|Number of Participants With ADV-associated Resistance at Week 48|Week 48 serum samples from participants, who reached a HBV DNA breakthrough or have HBV DNA≥5 log copies/mL at Weeks 24 and 48 were assessed for the development of ADV (Adefovir dipivoxil) mutation (N236T and A181V) in the HBV polymerase. Virologic breakthrough was defined as an increase in the level of HBV DNA 1 log10 copy/mL from Week 24 to Week 48. ADV-associated resistance was defined as participants with both virologic breakthrough and ADV mutation.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
2811350|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Week 48|HBeAg loss and HBeAg seroconversion (HBeAg loss and HBeAb detected) were assessed in participants who were HBeAg positive at Weeks 0 and 48. Confirmed HBeAg loss was defined as undetectable HBeAg.|Week 48|Intent-to-Treat (ITT) Population: all HBeAg positive participants who actually received the study medication at least once|||participants|||Number
2811351|NCT00441974|Secondary|Number of Participants Achieving ALT (Alanine Aminotransferase) Normalization at Week 48|Elevated serum ALT levels are defined as serum ALT levels greater than the upper limit of the normal range (ULN), as determined using local laboratory ranges. ALT normalization was defined as ALT measurements at or below the ULN after a baseline value above the ULN.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
2811352|NCT00441974|Secondary|Change From Screening in Median Serum HBV DNA at Weeks 24 and 48|The HBV DNA level was tested in blood serum by real-time Polymerase Chain Reaction with the LLD (lower limit of detection) as 300 copies/milliliter (cp/mL) at screening, week 24, and week 48 in a central laboratory. The change in HBV DNA from screening to week 24 and week 48 was conducted.|Weeks 24 and 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||log10 copies/milliliter||Full Range|Median
2811353|NCT00441974|Secondary|Ranked Assessment of Liver Histology in HBeAg Positive Participants From Baseline to Week 48|A ranked assessment with the Knodell/HAI scoring system that represents the sum of scores for periportal bridging necrosis (0-10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0-4: none=0, marked=4); portal inflammation (0-4: none=0, marked=4) and fibrosis (0-4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two pathologists in the HBeAg positive participants who underwent liver biopsy at baseline and Week 48/withdrawal.|Baseline to Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48|||points on a scale||Standard Deviation|Mean
2811354|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving Histological Improvement at Week 48|Histological improvement (defined as a ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was accessed by two pathologists in HBeAg-positive participants undergoing liver biopsy at baseline and week 48/withdrawal. Knodell/Histological Activity Index (HAI) score = combined scores for necrosis, inflammation, and fibrosis and is the sum of scores for periportal bridging necrosis (0-10: none=0, multilobular necrosis=10), intralobular degeneration and focal necrosis and portal inflammation (0-4: none=0, marked=4), and fibrosis (0-4: none=0, cirrhosis=4).|Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48|||participants|||Number
2811355|NCT00441974|Primary|Number of Participants Achieving HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) <1000 Copies/Milliliter at Week 48|HBV (Hepatitis B Virus) DNA level was tested by real-time Polymerase Chain Reaction at Week 48.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
2811356|NCT00441792|Primary|Length of Stay|The primary outcome of the study was hospital length of stay.|time in days of hospitalization|All patients entering into the study were analyzed on an intent to treat basis.|||days||Inter-Quartile Range|Median
2811357|NCT00441792|Secondary|Mortality|In-hospital mortality.|Duration of hospitalization.|All patients entering into the study were analyzed on an intent to treat basis.|||percentage of patients dying||95% Confidence Interval|Number
2811358|NCT00441766|Secondary|Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)|Change from baseline in the frequency of bowel movements per day using the BSS. The BSS categorizes stool based on the patient's description of its consistency. Patients are classified into 3 IBS subtypes according to their predominant stool patterns (C=constipation; D=diarrhea; M=mixed). A positive change from baseline in the IBS-C indicates improvement and a negative change from baseline in the IBS-D and IBS-M indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Bowel Movements (Stools) Per Day||Standard Deviation|Mean
2811359|NCT00441766|Secondary|Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4|"Percentage of patients who experienced AR-IBS at week 4. The AR-IBS is a self-evaluation by the patient of their perception of adequate relief of IBS pain over the last 7 days following treatment as compared to IBS pain before receiving treatment. Patients respond with either a Yes or No, where Yes indicated adequate relief of pain and No indicated no relief from pain."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Percentage of Patients|||Number
2811360|NCT00441766|Secondary|Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4|"Percentage of patients who rated their condition as improved on the SGIC at week 4. The SGIC score was assessed using a 7-point scale (score of 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). Patients self-evaluated their overall change in symptoms (relief from symptoms of abdominal discomfort, pain, and altered bowel habits). An improved condition was defined as a score of 1, 2, or 3."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Percentage of Patients|||Number
2811361|NCT00441766|Primary|Change From Baseline in Mean Highest-Average-Pain Score at Week 4|Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.|||Scores on a Scale||Standard Deviation|Mean
2811362|NCT00441727|Secondary|Number of Participants With Gastric and/or Duodenal Erosions.||The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|||participants|||Number
2811363|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.|||participants|||Number
2811387|NCT00441558|Primary|The Frequency of Adverse Events (Side Effects).|This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder|52 weeks||||participants with any adverse event|||Number
2811364|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.|||participants|||Number
2811365|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.|The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks||||percentage of participants|||Number
2811366|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.|The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks||||percentage of participants|||Number
2811367|NCT00441727|Primary|Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).|The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks||||percentage of participants|||Number
2811368|NCT00441701|Secondary|Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains|SGRQ consists of 76 items aggregated into 3 domain scores: Symptoms (frequency/severity), Activity (cause or limited by breathlessness), Impact (social functioning, psychological disturbances from airway disease), and total score. Participants were to assess their symptoms, activity and impact at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for SGRQ. Part 2 of this study was not conducted under this protocol.||||||
2811369|NCT00441701|Secondary|Part 2: Change From Baseline in Individual Symptom Scores|Participants were to be assessed for individual symptom scores at Baseline and Week 12 using the following scales: Sputum Production (0=none, unaware of any sputum production to 4=severe, an almost constant problem), Cough (0=none, unaware of coughing to 4=severe, never free of cough or need to cough), and Dyspnea (0=none, unaware of any difficulty to 4=severe, almost constant: present even when resting).|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for individual symptom scores. Part 2 of this study was not conducted under this protocol.||||||
2811370|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Part 2 of this study was not conducted under this protocol.||||||
2811371|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count|Participants were to be assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count. Part 2 of this study was not conducted under this protocol.||||||
2811372|NCT00441701|Secondary|Part 2: Change From Baseline in Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute via peak flow meter, is the maximum speed of expiration. Participants were to measure their PEF in triplicate every morning before taking study drug and again every evening.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for PEF. Part 2 of this study was not conducted under this protocol.||||||
2811373|NCT00441701|Secondary|Part 2: Number of Participants Who Experience a COPD Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration of systemic corticosteroids, antibiotics, an emergency room visit or a hospitalization. The number of participants who experienced a COPD exacerbation was to be summarized.|Up to Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a at least one post-Baseline assessment for presence of COPD exacerbation. Part 2 of this study was not conducted under this protocol.||||||
2811374|NCT00441701|Secondary|Part 2: Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters via body plethysmography, is the volume of air present in the lungs, specifically the parenchyma tissues, at the end of passive expiration. Participants were to be assessed for FRC at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FRC. Part 2 of this study was not conducted under this protocol.||||||
2811375|NCT00441701|Secondary|Part 2: Change From Baseline in FVC|FVC, as measured in liters via spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FVC. Part 2 of this study was not conducted under this protocol.||||||
2811388|NCT00441545|Secondary|Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks|Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)|4 weeks||||Percentage of Participants|||Number
2811389|NCT00441545|Secondary|Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks||Baseline and 4 weeks|ITT|||pg/mL||Standard Error|Mean
2811376|NCT00441701|Secondary|Part 2: Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%)|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute via spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. Participants were to be assessed for FEF25%-75% at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for FEF25%-75%. Part 2 of this study was not conducted under this protocol.||||||
2811377|NCT00441701|Secondary|Part 2: Change From Baseline in Post-Bronchodilator FEV1|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after dosing with bronchodilator (albuterol sulfate or equivalent) (reversibility test) at Baseline and Week 12. Post-bronchodilator data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for post-bronchodilator FEV1. Part 2 of this study was not conducted under this protocol.||||||
2811378|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum)|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least 1 dose of study drug, and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Since sufficient data for analysis were collected for absolute sputum neutrophil count, percent sputum neutrophil count was not assessed.||||||
2811379|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum)|Participants were assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. The reported SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count.|||10^9 cells/L||Standard Deviation|Mean
2811380|NCT00441701|Secondary|Part 1: Change From Baseline in Percent PBN Count|Participants were to be assessed for percent PBN counts at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and a Week 12 assessment for percent PBN count. Since sufficient data for analysis were collected for absolute PBN count, percent PBN count was not assessed.||||||
2811381|NCT00441701|Primary|Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score|Participants were to assess their morning (AM) and nighttime (PM) COPD symptoms (sputum production, cough, and dyspnea) on a daily basis in their e-Diaries. Baseline SCDS was defined as the average of AM and PM values over the week prior to and including Day 1 (AM) prior to the first dose of study drug. SCDS data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for AM/PM SCDS scores. Part 2 of this study was not conducted under this protocol.||||||
2811382|NCT00441701|Primary|Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for pre-bronchodilator FEV1 immediately before dosing with bronchodilator (albuterol sulfate or equivalent) at Baseline and at Week 12. Pre-bronchodilator FEV1 data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for FEV1. Part 2 of this study was not conducted under this protocol.||||||
2811383|NCT00441701|Primary|Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count|Participants were assessed for absolute PBN counts at Baseline and Week 12. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug and had a Baseline and a Week 12 assessment for absolute PBN count.|||10^9 cells/L||Standard Deviation|Mean
2811384|NCT00441701|Primary|Part 1: Number of Participants Who Discontinue Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.|||Participants|||Number
2811385|NCT00441701|Primary|Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.|||Participants|||Number
2811386|NCT00441584|Primary|Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment|Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is < 30 IU/mL in this study.|Up to 48 weeks of treatment plus 24 weeks follow up|The All Treated population included all subjects who took at least one dose of study medication.|||Participants|||Number
2811390|NCT00441545|Secondary|Change From Baseline in Serum Calcium Levels at 4 Weeks||4 weeks|ITT|||mg/dL||Standard Error|Least Squares Mean
2811391|NCT00441545|Primary|Change From Baseline in Serum Phosphorus Levels at 4 Weeks||4 weeks|ITT population defined as subjects who were randomized, received at least one dose of investigational product, and had at least one post-dose assessment of the primary efficacy variable.|||mg/dL||Standard Error|Least Squares Mean
2811392|NCT00441480|Secondary|Apolipoprotein A|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811393|NCT00441480|Secondary|Apolipoprotein A|Blood test on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811394|NCT00441480|Secondary|Apolipoprotein B100|Blood test results follwing 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811395|NCT00441480|Secondary|Apolipoprotein B100|Blood test results on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811396|NCT00441480|Secondary|CRP|Blood test results following 12 weeks of intervention of High sensetivity C reactive protein|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/l||Standard Deviation|Mean
2811397|NCT00441480|Secondary|CRP|Blood test results on day 0 of High sensitivity C Reactive Protein|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/l||Standard Deviation|Mean
2811398|NCT00441480|Secondary|HDL-cholestrol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811399|NCT00441480|Primary|LDL-C|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||md/dl||Standard Deviation|Mean
2811400|NCT00441480|Secondary|HDL Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811401|NCT00441480|Secondary|Total Cholesterol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811402|NCT00441480|Secondary|Total Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811403|NCT00441480|Secondary|Triglycerides|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811404|NCT00441480|Secondary|Triglycerides|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811405|NCT00441480|Primary|LDL Cholesterol|Average of blood test results at -10 and 0 days (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points|||mg/dl||Standard Deviation|Mean
2811406|NCT00441467|Secondary|Overall Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.||||months||95% Confidence Interval|Median
2811407|NCT00441467|Secondary|Progression-free Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.||||months||95% Confidence Interval|Median
2814021|NCT00424554|Primary|MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery|An experimental assay was developed to measure MGMT levels.|14 days|"All participants for which a MGMT activity assay could be~performed"|||fmol/mg of proteins||Standard Deviation|Mean
2811408|NCT00441467|Primary|Objective Response Rate|The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.|Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.|Patients receiving glufosfamide with a post treatment imaging assessment|||participants|||Number
2811409|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline: Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population|||ratio|||Number
2811410|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanomoles per 24 hr (nmoles/24 hr)||Full Range|Geometric Mean
2811411|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population|||ratio|||Number
2811412|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanamoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
2811413|NCT00441441|Secondary|Percent of Albuterol-free Days|Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.|||Percentage of days||Standard Error|Mean
2811414|NCT00441441|Secondary|Albuterol Use|Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.|||Number of puffs per 24 hours||Standard Error|Mean
2811415|NCT00441441|Secondary|Percentage of Symptom Free Days|Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.|||Percentage of days||Standard Error|Mean
2811416|NCT00441441|Secondary|Asthma Symptom Scores|Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.|||Score in scale||Standard Error|Mean
2811417|NCT00441441|Secondary|AM Peak Expiratory Flow|The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT Population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 173 and 174 at Weeks 1-12; and 171 and 173 for the last 7 days on treatment.|||Liters/minute (L/min)||Standard Error|Mean
2811418|NCT00441441|Secondary|Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years|"FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining best effort from 3 to 8 measurements. Week 12 is the measure taken at Week 12."|Baseline and week 12|Subset of ITT Population: Participants who were 6-11 years of age (population not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 137 and 136 at baseline; 126 and 124 at Week 12, and 6 and 7 at premature discontinuation.|||Liters per second (L/sec)||Standard Error|Mean
2811725|NCT00439647|Secondary|Number of Participants With First Clinical Fracture|Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.|||Participants|||Number
2811419|NCT00441441|Primary|Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population|||ratio|||Number
2811420|NCT00441441|Primary|Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
2811421|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use|"AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and Week 12|Cortisol Population|||participants|||Number
2811422|NCT00441441|Primary|Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion|Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population|||ratio|||Number
2811423|NCT00441441|Primary|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population|||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
2811424|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion|"Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and week 12|Cortisol Population - all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of post-baseline urine collection.|||participants|||Number
2811425|NCT00441441|Primary|Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols|The Primary Investigator determined the severity of the exacerbation based on the participant's clinical presentation and the investigator's understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful.|Treatment period (weeks 1-12)|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
2811426|NCT00441441|Primary|Cardiovascular Adverse Events Reported During the Post-Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.|5 Days after Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
2811427|NCT00441441|Primary|Cardiovascular Adverse Events Reported During Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.|12-Week Treatment Period|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
2811428|NCT00441441|Primary|ECG Measures - QT Interval|Fridericia's formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett's formula QTc=QT/squared root of the R-R interval.|Baseline and Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||milliseconds||Full Range|Mean
2811429|NCT00441441|Primary|ECG Measures - Heart Rate|The range of heart rates for this study was between 49-144 beats per minute|Baseline and Week 12|ITT Population - All subjects who were randomized and received at least one dose of double-blind study treatment.|||beats per minute||Full Range|Mean
2811568|NCT00440726|Post-Hoc|Bone Marrow Response|"M1: Less than 5% blasts in a bone marrow aspirate and at least 200 cells counted.~M2: 5-25% blasts in a bone marrow aspirate with at least 200 cells counted. M3: Greater than 25% blasts in a bone marrow aspirate with at least 200 cells counted."|Day 29 of Course 1|All patients who enrolled and treated under Phase 2 will be evaluated at the end of Course 1 for treatment response as indicated by measure of bone marrow (M1, M2, or M3) or patient survival if death occurred.|||Participants|||Count of Participants
2811430|NCT00441441|Primary|Clinically Significant Unfavorable ECGs at Week 12|Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.|Baseline, Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The numbers of participants at Week 12 were 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.|||participants|||Number
2811431|NCT00441441|Primary|Investigator Evaluations of Electrocardiogram (ECG) Results|ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants' history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation.|Baseline and Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The number of participants at Week 12 was 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.|||participants|||Number
2811432|NCT00441441|Primary|Possible Drug-Related Adverse Events|Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.|Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)|Intent-to-Treat (IITT) Population - All participants who were randomized and received at least one dose of double-blind study treatment.|||participants|||Number
2811433|NCT00441363|Secondary|Number of Serious Adverse Events Experienced by the Subjects||up to 24 weeks|Report of Serious adverse events that occurred in the trial.|||serious adverse events|||Number
2811434|NCT00441363|Secondary|Fasting Plasma Glucose and Lipids||up to 24 weeks|||||||
2811435|NCT00441363|Primary|Change in Baseline to End of Study in HbA1c|Too few subjects were enrolled to assess outcome to pre-specified statistical power.|up to 24 weeks||||% HbA1c||Standard Deviation|Mean
2811436|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
2811437|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
2811438|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
2811439|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.|||mmHg||Standard Deviation|Mean
2811440|NCT00441337|Secondary|Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population|12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).|Baseline, Day 2, Day 85, Day 113|All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.|||msec||Standard Deviation|Mean
2811441|NCT00441337|Secondary|Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population|PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.|Day 29, Day 57, Day 85|The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.|||percentage of total PSA level||Full Range|Median
2811442|NCT00441337|Secondary|Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population|Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method.|Day 1 to 2 Years|The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment.|||days||95% Confidence Interval|Median
2811443|NCT00441337|Secondary|Time to Tumor Progression and Tumor Progression Free Survival|Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||days||95% Confidence Interval|Median
2811444|NCT00441337|Secondary|Median Time to Tumor Response and Duration of Tumor Response|Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab and were tumor responders were analyze.|||days||95% Confidence Interval|Median
2811445|NCT00441337|Secondary|Percentage of Participants With Disease Control and Major Durable Disease Control|Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.|Day 1 to 2 Years|Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.|||percentage of participants||95% Confidence Interval|Number
2811446|NCT00441337|Secondary|Number of Participants With Best Overall Response (BOR) by Category in Safety Population|Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12.|Day 1 to Day 85|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
2811454|NCT00441337|Primary|Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2811447|NCT00441337|Primary|Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC)|The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method.|Day 1 to Day 85|The PSA evaluable population was analyzed and included all HRPC participants who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least one post baseline PSA assessment. A PSA evaluable participant could not have any major inclusion/exclusion violation, dosing violation, or protocol conduct violation.|||percentage of participants||95% Confidence Interval|Number
2811448|NCT00441337|Primary|Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population|The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method.|Day 1 up to 2 Years.|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. Tumor Evaluable Population: all participants who received complete dose(s) of nivolumab and had completed a major tumor assessment (a baseline and at least 1 post-baseline tumor assessment for either target and/or non-target assessments.|||percentage of participants||95% Confidence Interval|Number
2811449|NCT00441337|Primary|Mean Volume of Distribution (Vz) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||mL/kg||Standard Deviation|Mean
2811450|NCT00441337|Primary|Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2811451|NCT00441337|Primary|Mean Elimination Half-life (T-HALF) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||days||Standard Deviation|Mean
2811452|NCT00441337|Primary|Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose|AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2811453|NCT00441337|Primary|Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.|||h||Full Range|Median
2811498|NCT00441116|Secondary|Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.|Sodium, Potassium (mEq/L), and Bicarbonate|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||mmol/L||Standard Deviation|Mean
2811455|NCT00441337|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.|Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
2811456|NCT00441285|Secondary|Phase III Trial - Seizure Frequency|Seizure frequency by treatment group|Day 1 - 540|Final population numbers for this analysis not yet defined||||||
2811457|NCT00441285|Primary|Phase III Trial - Proportion of Patients Without Remaining Live Cysts|Proportion of patients whose 6 month MR does not show viable parasites anymore|Day 180|Some patients did not reach the analysis time point.|||participants|||Number
2811458|NCT00441285|Secondary|Phase III Trial - Proportion of Cysts Which Resolved|Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI|Day 180|Final population numbers for this analysis not yet defined||||||
2811459|NCT00441285|Secondary|PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy|- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.|90 days post tx||||Events|||Number
2811460|NCT00441285|Primary|PK Substudy - Maximum Concentration of Albendazole|Highest serum level of Albendazole measured from all level assessments in the curve.|Treatment day 1 and Treatment days 10-11||||ng/mL||Standard Deviation|Mean
2811461|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11||||ng*h/ml||95% Confidence Interval|Mean
2811462|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1|Carbamazepine and Phenytoin were not assigned by the study.|||ng*h / mL||Standard Deviation|Mean
2811463|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11||||ng*h/ml||95% Confidence Interval|Mean
2811464|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1||||ng*h/mL||95% Confidence Interval|Mean
2811465|NCT00441272|Secondary|Insulin Resistance||48 weeks|||||||
2811466|NCT00441272|Primary|Hepatic Steatosis|Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.|96 weeks|A total of 11 subjects enrolled into the study. 10 were determined to be ineligible during the screening as the Computerized tomography scan revealed a liver-to-spleen ratio > 1 and one was determined ineligible due to concomitant medication use.|||Hounsfeld units||Standard Deviation|Mean
2811467|NCT00441259|Secondary|Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post-vaccination|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2811468|NCT00441259|Secondary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post Dose 1|Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.|||Participants|||Number
2811469|NCT00441259|Primary|Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post Dose 1|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2819056|NCT00390780|Secondary|Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet|Number of patients with detectable plasma concentration at Visit 3 (day 7)|7 days|ITT (all randomized patients who took at least 1 dose of study medication)|||participants|||Number
2811470|NCT00441259|Primary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post-vaccination|Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.|||Participants|||Number
2811471|NCT00441259|Primary|Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.|||Participants|||Number
2811472|NCT00441259|Primary|Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.|||Participants|||Number
2811473|NCT00441168|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = ([Date of PD or date of censoring - Date of best response]+1)/30.44.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).|||months|||Number
2811474|NCT00441168|Primary|Best Reported Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the EBMT criteria as assessed by the investigator. The ordering of the responses was: CR, PR, MR, NC and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.|||participants|||Number
2811475|NCT00441168|Primary|Best Confirmed Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease [PD], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.|||participants|||Number
2811476|NCT00441142|Secondary|PHASE I: Percentage of Grade 3-5 Treatment-Related Adverse Events|The percentage of adverse events (based on CTCAEv3) reported on study (via case report forms and Reportable AE submissions) that are both high-grade (grade 3, 4, or 5) and considered at least possibly related to study treatment.|Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 7 years.||||percentage of events||95% Confidence Interval|Number
2811477|NCT00441142|Secondary|PHASE II: Percentage of Grade 3-5 Treatment-Related Adverse Events|The percentage of adverse events (based on CTCAEv3) reported on study (via case report forms and Reportable AE submissions) that are both high-grade (grade 3, 4, or 5) and considered at least possibly related to study treatment.|Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 6 years.||||percentage of events||95% Confidence Interval|Number
2811478|NCT00441142|Secondary|Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free|A secondary outcome of Phase II of this trial is the median progression-free survival (PFS), as calculated by the # of months patients remain progression-free|3 years|This is an outcome for Phase II participants only; 0 Phase I participants were included in the analysis.|||months||95% Confidence Interval|Median
2811479|NCT00441142|Primary|Median Overall Survival (OS) of Phase II Patients|The primary outcome of Phase II of this trial was to determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival.|3 years|This measure was only assessed in Participants in Phase II part of the study, who had available data for analysis|||months||95% Confidence Interval|Median
2811480|NCT00441142|Primary|Number of Participants That Experienced a Dose-limiting Toxicity (DLT)|The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|2 years|This measure was only assessed in Participants enrolled into the Phase I part of the study who had available data for analysis.|||Participants|||Number
2811481|NCT00441129|Secondary|Change From Baseline in Total Daily Dose (TDD)|Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline|Baseline and 6 months||||units/day||Standard Deviation|Mean
2811482|NCT00441129|Secondary|Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.|Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline|Baseline and 6 months||||mg/dL||Standard Deviation|Mean
2811483|NCT00441129|Primary|Difference in HbA1C From Baseline and 6 Months|Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline|Baseline and 6 months||||percentage of HbA1C||Standard Deviation|Mean
2811484|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811485|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811486|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811487|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811488|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811489|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811490|NCT00441116|Secondary|Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811491|NCT00441116|Secondary|Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811492|NCT00441116|Secondary|Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811493|NCT00441116|Secondary|Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Baseline|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811494|NCT00441116|Secondary|Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Screening|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811495|NCT00441116|Secondary|Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.|Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)|Baseline and Month 6|Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||mg/dL||Standard Deviation|Mean
2811496|NCT00441116|Secondary|Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.|sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||IU/L||Standard Deviation|Mean
2811497|NCT00441116|Secondary|Laboratory Values: Hematology Assessed at Baseline and 6 Months.|Comparing Lab values and differences from Baseline to month 6|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||thousands/microliter||Standard Deviation|Mean
2811499|NCT00441116|Secondary|Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10.|Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L.|Baseline to Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.|||Participants|||Number
2811500|NCT00441116|Secondary|The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10|Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.|Month 3, Month 6, and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Percent change||Standard Deviation|Mean
2811501|NCT00441116|Secondary|The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10|Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.|Month 3, Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Percent change||Standard Deviation|Mean
2811502|NCT00441116|Secondary|Panel Assessment of Improvement Distribution From Screening|"Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count.~Score Range -3=greatly decreased to +3=greatly increased. 0=No change."|Baseline to Month 3 and Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811503|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvements From Baseline Score|Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.|Month 3 and Month 6|Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.|||units on a scale||Standard Deviation|Mean
2811504|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvement Distribution From Baseline|Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811505|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811506|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811507|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811508|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811509|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811510|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.|||Participants|||Number
2811567|NCT00440830|Primary|Postoperative Pain Score One Hour After Surgery|Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|1 hour after surgery||||Numeric Rating Scale (NRS)||Standard Deviation|Mean
2811511|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811512|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||Participants|||Number
2811513|NCT00441116|Secondary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||hair count per centimeters squared||Standard Deviation|Mean
2811514|NCT00441116|Primary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and 6 months|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.|||hair count per centimeters squared||Standard Deviation|Mean
2811515|NCT00441103|Secondary|Number of CU Active MRI Lesions|CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting).|Up to Week 40|ITT population included all randomized participants who received at least one dose of study drug.|||lesions||Standard Deviation|Mean
2811516|NCT00441103|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).|Baseline up to Week 40|Safety population included all randomized participants who received at least one dose of study drug. Here, 'n' signifies those participants who were evaluable for the specified category.|||participants|||Number
2811517|NCT00441103|Secondary|Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.|"CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting). Only Placebo Followed by RNF arm was evaluable for this outcome measure."|Day 1 up to Week 16 and Week 17 up to Week 40|"ITT population included all randomized participants who received at least one dose of study drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||lesions||Standard Deviation|Mean
2811518|NCT00441103|Primary|Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16|CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).|16 Weeks|ITT population included all randomized participants who received at least one dose of study drug.|||lesions||Standard Deviation|Mean
2811519|NCT00441090|Other Pre-specified|To Evaluate the Pharmacokinetics (PK) and the Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship of Avatrombopag in Patients With ITP.|Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.|Days 7, 14, 21 and 28|Given the sparse PK sampling in this study, PK data from outside studies, which includes healthy subjects, were included to assist in PK model development. As a result this data was not reported with these study results.||||||
2811520|NCT00441090|Secondary|Percentage of Participants Whose Platelet Counts Doubled From Baseline by Visit|Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
2811521|NCT00441090|Secondary|Percentage of Participants With Platelet Counts Greater Than or Equal to 100,000/mL by Visit|Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
2811611|NCT00440297|Primary|The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C||Days 1-5 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up|||Participants|||Number
2811522|NCT00441090|Secondary|Percentage of Participants With Platelet Counts Greater Than or Equal to 50,000/mL by Visit|Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28.|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, and Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
2811523|NCT00441090|Secondary|Responder Rate to Avatrombopag by Visit|Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, and 21. The RR was summarized by treatment group using the method of LOCF. Day 28 was not included with this data because it was reported as a primary outcome measure.|Day -4 to Day 1, Baseline, Day 7, Day 14, and Day 21|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
2811524|NCT00441090|Secondary|Change in Platelet Count From Baseline|"Platelet counts were measured from the participant's, blood which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Days 7, 14, 21, and 28. The unit of measure was K/mm^3, where K = platelets x 1000 = platelets x 10^3 and mm^3 = cubic milliliter= microliter."|Day -4 to Day 1, Baseline, Day 7, Day 14, Day 21, Day 28|Full Analysis population, LOCF|||platelets x 10^3/mm^3||Standard Deviation|Mean
2811525|NCT00441090|Primary|Responder Rate (RR) to Avatrombopag on Day 28|Platelet counts were measured from the participant's blood, which was drawn at their Screening Visit B (Day -4 to Day 1, Baseline), and on study drug treatment Day 28. The RR was defined as the percentage of participants with a Day 1 platelet count of less than 30,000/milliliter (mL) who reached a platelet count of greater than or equal to 50,000/mL on Day 28 of study medication, together with the percentage of participants using steroids who had a Day 1 platelet count greater than or equal to 30,000/mL but less than 50,000/mL who reached a platelet count of greater than or equal to 20,000/mL higher than their Day 1 platelet count on Day 28 of study medication. The RR was summarized by treatment group using the method of last observation carried forward (LOCF).|Day-4 to Day 1, Baseline, Day 28|Full analysis population, LOCF, included participants who were randomly assigned to treatment and had at least one post-baseline platelet count assessment. The randomized, full analysis, and safety populations were identical for this study. No participants were excluded from the efficacy analysis.|||Percentage of participants|||Number
2811526|NCT00441064|Secondary|Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline of ≥20 mm Hg in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and Week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets|||Percentage of responders|||Number
2811527|NCT00441064|Secondary|Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the mean 24 hour ambulatory diastolic blood pressure (MADBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets|||mm Hg||Standard Deviation|Mean
2811528|NCT00441064|Primary|Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets|||mm Hg||Standard Deviation|Mean
2811529|NCT00441012|Secondary|The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||µg /mL||95% Confidence Interval|Geometric Mean
2811530|NCT00441012|Secondary|The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.|"The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after~the third dose)"|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
2811531|NCT00441012|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)|0-11 months (recorded from first dose until the participant completes or discontinues)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
2811532|NCT00441012|Primary|The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2811533|NCT00441012|Primary|The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
2811534|NCT00440947|Secondary|Mean Percent Compliance at Week 144|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 144|ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.|||percent compliance||Standard Deviation|Mean
2811535|NCT00440947|Secondary|Mean Percent Compliance at Week 84|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 84|ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.|||percent compliance||Standard Deviation|Mean
2811536|NCT00440947|Secondary|Mean Percent Compliance at Week 36|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 36|ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.|||percent compliance||Standard Deviation|Mean
2811537|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations|||participants|||Number
2811538|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Randomization at Week 36 through Week 84|Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
2811539|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
2811540|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.|||participants|||Number
2811612|NCT00440297|Primary|The Total Number of Participants With One or More Injection-Site Adverse Experiences||Days 1-15 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up|||Participants|||Number
2811541|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Randomization at Week 36 through Week 84|Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
2811542|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.|||participants|||Number
2811543|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 144|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.|||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
2811544|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 84|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.|||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
2811545|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 36|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.|||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
2811546|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 144|Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.|||log10 c/ml||Standard Deviation|Mean
2811547|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 84|Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.|||log10 c/ml||Standard Deviation|Mean
2811548|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 36|Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.|||log10 c/ml||Standard Deviation|Mean
2811549|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 144|The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 144|ITT-Extension Population, Extension Phase. TLOVR.|||participants|||Number
2811550|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 84|The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 84|ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.|||participants|||Number
2811551|NCT00440947|Secondary|Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36|The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 36|ITT-E Population, Induction Phase|||participants|||Number
2811552|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase|||percentage of participants|||Number
2811553|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 84|ITT-E Population, Randomized Phase|||percentage of participants|||Number
2811554|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 36|ITT-E Population, Induction Phase|||percentage of participants|||Number
2811555|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study|||percentage of participants|||Number
2811556|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit|A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.|Week 84|ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.|||percentage of participants|||Number
2811557|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.|Week 36|ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study|||percentage of participants|||Number
2811558|NCT00440947|Secondary|Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase|The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.|Baseline of Randomized Phase|ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase|||years||Standard Deviation|Mean
2811559|NCT00440947|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.|Week 84|Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA <50 c/ml at Week 84 in the Simplification arm and Continuation arms|||percentage of participants|||Number
2811560|NCT00440830|Primary|Postoperative Pain Score Five Days After Surgery|Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|5 days||||Numeric Rating Scale (NRS)||Standard Deviation|Mean
2811561|NCT00440830|Secondary|Heart Rate|Heart rate reported in Beats per minute (BPM)|1 hour after surgery|||||||
2811562|NCT00440830|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery|||||||
2811563|NCT00440830|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery|||||||
2811564|NCT00440830|Secondary|Pain Medication Used|Pain medication used after surgery in morphine equivalents|5 days|||||||
2811565|NCT00440830|Secondary|Sedation|Observer's Assessment of Alertness/Sedation Scale was used to report sedation.|1 hour after surgery|||||||
2811566|NCT00440830|Secondary|Nausea Assessment by Patient|Nausea scale range: 0=none and 10=the worst, ordinal.|1 hour after surgery|||||||
2811569|NCT00440726|Primary|Achievement of Complete Remission (CR)|"Complete Remission (CR): M1 (< 5% blasts) BM with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC>750/uL and platelet count >75 000/uL);~Complete Remission without Platelet Recovery (CRp): M1 BM with no circulating blasts or extramedullary disease and recovery of ANC (>750/uL) but insufficient recovery of platelets (<75 000/uL).~Partial Remission (PR): the disappearance of circulating blasts and achievement of M2 (5%-25% blasts) marrow status, without new sites of extramedullary disease, and with recovery of ANC (>750/uL).~Stable disease (SD): not satisfying the criterion for progressive disease (PD), or a recovery of ANC (>750/uL) but fails to qualify for CR, CRp, or PR.~Progressive Disease (PD): increase of at least 25% in the absolute number of circulating leukemia cells, development of new sites of extramedullary disease, or other lab or clinical evidence of PD, with or without recovery of ANC or platelets."|Day 29 of Course 1|One Ph 1 patient received incorrect doses of Dexamethasone, so not evaluable for response. One Phase 2 patient achieved BM M1 but was treated with additional chemotherapy before peripheral recovery, so response to protocol treatment could not be evaluated.|||Participants|||Count of Participants
2811570|NCT00440726|Primary|Occurrence of a Dose-Limiting Toxicity (Phase 1)|Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4 Non-Hematologic Toxicity excluding the following: Infection (septic shock, typhlitis), Fever/Neutropenia, Fatigue, Electrolyte abnormalities, Hyper/Hypoglycemia, Nausea or Vomiting, AST/ALT/Bilirubin elevations that return to grade 1 by the time of the next course.|Beginning with the first dose of investigational product until 30 days following the last dose of bortezomib||||Participants|||Count of Participants
2811571|NCT00440700|Secondary|Urinary Cortisol|Stress was measured by the biomarker urinary cortisol. 24-hour urine collections were obtained from eligible participants who were not receiving steroids or other medications known to affect cortisol and who had intact renal function. 24-hour urinary cortisol results were used as an integrative measure of stress (mg/day).|Daily up to 30 days|All participants with functioning kidneys who were not receiving steroids or other medications known to affect cortisol and who had two or more 24-hour urine collections were included in the analysis.|||total milligrams per day||Full Range|Median
2811572|NCT00440700|Secondary|Length of Mechanical Ventilatory Support|Length of mechanical ventilatory support was defined as the number of days from initial intubation and placement on mechanical ventilation to the day of extubation or death for participants in each group.|From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.|Includes all subjects enrolled regardless of length of protocol participation. Mean number of days mechanically ventilated was calculated for the subjects randomized to each group/arm.|||days||Standard Error|Mean
2811573|NCT00440700|Secondary|Length of ICU Stay|Length of ICU stay was measured in days from the first day participant was admitted to the unit until discharged, transferred, or died in the ICU. This was the total time that any participant was in the intensive care unit which could have been longer than the 30 study protocol .|From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days|The number of participants includes all of those patients who were enrolled into the study protocol, regardless of their length of study participation.|||days||Standard Error|Mean
2811574|NCT00440700|Primary|State Anxiety|"Participants reported their current level of anxiety each day enrolled in the study in response to the question how are you feeling today/ The Visual analog scale-anxiety was used to evaluate the self-report of anxiety. Scores range from 0 = not anxious at all to 100 = the most anxious ever. Higher numbers indicate greater anxiety. Daily anxiety scores from all subjects were combined and analyzed for each group resulting in an overall mean anxiety score at the end of the study protocol of 30 days."|Daily up to 30 days|Participants with 3 or more visual analog scale-anxiety ratings were included in the analysis.|||units on a scale||Standard Deviation|Mean
2811575|NCT00440700|Primary|Sedative Exposure|Sedative exposure was measured by: 1) the number (dose frequency) of sedative medication doses administered in a 4-hour time period each day and 2) by an aggregate dose intensity of sedative medications administered in a 4-hour time period each day based on all subjects receiving sedative medications on any individual study day yielding a sedation intensity score. A sedation intensity score was calculated for each study group each study protocol day, up to 30 days. Higher sedation intensity scores indicate more sedative exposure. If a subject did not receive any sedation, the sedative exposure score is zero for that respective day.|Daily up to 30 days|Participants with 2 or more days of study enrollment data were included in the analysis for this aim.|||exposures/4-hours per day||Full Range|Median
2811576|NCT00440557|Secondary|Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.|From baseline to Week 9|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.|||participants|||Number
2811577|NCT00440557|Post-Hoc|Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment|Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||g/dL/2 weeks||Standard Deviation|Mean
2811578|NCT00440557|Other Pre-specified|Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||participants|||Number
2811579|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||participants|||Number
2811580|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.|||participants|||Number
2811581|NCT00440557|Other Pre-specified|Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||g/dL||Standard Deviation|Mean
2811582|NCT00440557|Other Pre-specified|Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.|||participants|||Number
2811583|NCT00440557|Primary|Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.|From baseline through Week 22|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.|||g/dL||Standard Deviation|Mean
2811584|NCT00440531|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences||During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
2811585|NCT00440531|Secondary|The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C||Day 1-5 After Vaccination|Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
2811586|NCT00440531|Secondary|The Total Number of Participants With One or More Injection-site Adverse Experiences||Days 1-5 After Any Vaccination|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.|||Participants|||Number
2811587|NCT00440531|Secondary|The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
2811588|NCT00440531|Primary|The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
2811589|NCT00440518|Secondary|Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)|Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person's ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject's quality of life.|Baseline, last visit in the 17-week Trial Period|Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.|||Scores on a scale||Standard Deviation|Mean
2811590|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Participants|||Number
2811591|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Participants|||Number
2811592|NCT00440518|Secondary|Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Number of migraine headaches||Standard Deviation|Mean
2811593|NCT00440518|Primary|Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.|||Number of migraine headaches||Standard Deviation|Mean
2811594|NCT00440505|Secondary|Nausea|Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2811595|NCT00440505|Secondary|Number of Participants Who Reported an Increase in Daily Pain Medication Regime|Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.|||Participants|||Number
2811596|NCT00440505|Secondary|Patient Self-assessment of Psychological Distress|Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.|||Units on a scale||Standard Deviation|Mean
2811597|NCT00440505|Primary|Pain Score|Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.|||Units on a scale||Standard Deviation|Mean
2811598|NCT00440466|Other Pre-specified|Number of Participants Who Died||36 weeks of treatment||||Participants|||Number
2811599|NCT00440466|Other Pre-specified|Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||g/dL/2 weeks||Standard Deviation|Mean
2811600|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||Participants|||Number
2811601|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment||||Participants|||Number
2811602|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||Particpants|||Number
2811603|NCT00440466|Other Pre-specified|Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||g/dL||Standard Deviation|Mean
2811604|NCT00440466|Other Pre-specified|Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug|||Participants|||Number
2811605|NCT00440466|Secondary|Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)||Weeks 13-37|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.|||Proportion||Full Range|Median
2811606|NCT00440466|Primary|Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment||from baseline (Week 1) to the last 12 weeks of treatment|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.|||g/dL||Standard Deviation|Mean
2811607|NCT00440401|Secondary|Proportion of Subjects Achieving Haemostasis at 6 Minutes.|Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|6 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."|||Proportion of Subjects||95% Confidence Interval|Number
2811608|NCT00440401|Primary|Proportion of Subjects Achieving Haemostasis at 3 Minutes|Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|3 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."|||Proportion of Subjects||95% Confidence Interval|Number
2811609|NCT00440310|Primary|Overall Survival|Time from randomization to death|Up to 184 weeks|ITT (All patient randomized/enrolled)|||Days||Inter-Quartile Range|Median
2811610|NCT00440297|Primary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).|0-9 months (recorded from first dose until the participant completes or discontinues the study)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up|||Participants|||Number
2811613|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9|"The number of participants as measured by the~seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose)."|9 months (1 month after the fourth dose)|"Per-Protocol Population: The Per-~Protocol Population is defined as the participants that were able to complete the study as defined by the~protocol."|||Participants|||Number
2811614|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7|"The number of participants as measured by the~seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose)."|7 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.|||Participants|||Number
2811615|NCT00440271|Secondary|Post-dose TPV and RTV Concentrations at Week 4||Week 4|||||||
2811616|NCT00440271|Secondary|Occurrence of TPV Trough Concentration >120 μM||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811617|NCT00440271|Secondary|Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811618|NCT00440271|Secondary|Patients Adherence With Study Medication Based on Pill Count||after 4 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811619|NCT00440271|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811620|NCT00440271|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811621|NCT00440271|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811622|NCT00440271|Secondary|Time to New AIDS or AIDS Related Progression Event or Death||after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811623|NCT00440271|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811624|NCT00440271|Secondary|Change in Viral Load From Baseline at Each Visit||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811625|NCT00440271|Secondary|Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811626|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811627|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811628|NCT00440271|Primary|Treatment Response at Week 48|percentage of participants whose viral load <50 copies/mL at Week 48|after 48 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.||||||
2811629|NCT00440232|Secondary|Time to Development of Headache of Any Intensity|Time to development of headache of any intensity in the 2 treatment arms|20 hours||||hours||95% Confidence Interval|Mean
2811630|NCT00440232|Primary|Incidence of Fasting-induced Headache of Any Intensity|Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting|20 hours||||participants|||Number
2811703|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811631|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811632|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811633|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811634|NCT00440193|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811635|NCT00440193|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811636|NCT00440193|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811644|NCT00440193|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811637|NCT00440193|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811638|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811639|NCT00440193|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
2811640|NCT00440193|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
2811641|NCT00440193|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
2811642|NCT00440193|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811643|NCT00440193|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811661|NCT00439946|Secondary|Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8||||participants|||Number
2811645|NCT00440193|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811646|NCT00440180|Primary|Pregnancy Rate|Partner pregnancy rate during study participation|4 months||||participants partner|||Number
2811647|NCT00440115|Secondary|Progress in Stage of Change|Progress in Stages of Change at 6, 12, 18, and 24 months|6, 12, 18, 24 months||||Participants|||Count of Participants
2811648|NCT00440115|Secondary|Number of Quit Attempts|Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.|6, 12, 18, 24 months||||quit attempts|||Number
2811649|NCT00440115|Primary|7-day Point Prevalence Abstinence From Cigarettes|Self-reported 7-day point prevalence abstinence from cigarettes|24 months|We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis.|||Participants|||Count of Participants
2811650|NCT00440050|Secondary|Neuropsychiatric Inventory (NPI)|The Neuropsychiatric Inventory quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.|18 months||||Units on a scale||Standard Deviation|Mean
2811651|NCT00440050|Secondary|ADCS-ADL|ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower numbers indicating greater impairment.|18 months||||Units on a scale||Standard Deviation|Mean
2811652|NCT00440050|Primary|Rate of Change on CDR-SOB|CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|18 months||||Units on a scale||Standard Deviation|Mean
2811653|NCT00440050|Primary|Rate of Change on the ADAS-Cog 11.|ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|Baseline, 6, 12, 18 months||||ADAS points per year||Standard Deviation|Mean
2811654|NCT00440037|Secondary|Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)|"Short Form 36 (SF-36): The SF-36 has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. In addition to deriving a score for each of the domains, the SF-36 generates 2 summary scores: a physical component summary (PCS) and a mental component summary (MCS). These 8 domains and 2 summary scores are scored from 0 to 100, with higher scores indicating better health status. The official version in Japanese was used in this study.~Euroqol-5 Dimensions (EQ-5D): The EQ-5D is a patient-completed, multidimensional measure of HRQOL. EQ-5D index values range from -0.59 to 1.00. The EQ-5D visual analogue scale (VAS) records the respondents' self-rated health status on a vertical graduated (0 to 100) visual analogue scale. Higher EQ-5D Index and VAS scores represent better health status. The official version in Japanese was used in this study."|By Week 48||||score on a scale||Standard Deviation|Mean
2811655|NCT00440037|Secondary|Percentage of Subjects Able to Reduce or Discontinue Their Concurrent ITP Therapies (for Subjects That Are Receiving Oral Corticosteroids at a Constant Dose and Schedule at the Screening Visit)||Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)|Subjects who were receiving concurrent ITP therapy at baseline|||percentage of participants|||Number
2811656|NCT00440037|Secondary|Incidence of Platelet Response (Platelet Response is Defined as a Doubling of Baseline Platelet Counts and More Than 50 x 10^9/L; Baseline Platelet Counts is That Obtained in the Previous Study)||Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)||||percentage of participants||95% Confidence Interval|Number
2811657|NCT00440037|Secondary|Incidence of Anti AMG 531 Antibody Formation|Subjects with positive anti-AMG 531 antibodies (either to the peptide portion of AMG 531 or to the intact molecule) and antibodies that cross-react with endogenous thrombopoietin (TPO)|Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)|Subjects with at least 1 immunoassay available|||percentage of participants|||Number
2811658|NCT00440037|Primary|Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values.|Subjects who reported at least 1 adverse event after beginning treatment with romiplostim in this study|Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)|Subjects in Safety Analysis Set|||percentage of participants|||Number
2811659|NCT00440011|Secondary|Tolerability - Conjunctival Hyperemia|Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)|Month 3||||participants|||Number
2811660|NCT00440011|Primary|Intraocular Pressure (IOP)|Intraocular Pressure|Month 3||||mm Hg||Standard Deviation|Mean
2811736|NCT00439569|Secondary|Overall Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 Weeks|Four of the nine subjects enrolled were less than 80% compliant. The study was closed prematurely due to poor compliance with study drug administration.|||Participants|||Number
2811662|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua (e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|All 8 participants are included.|||units on a scale||Standard Deviation|Mean
2811663|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0-25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0-30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0-25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous ('True'/'Not true') response options while the Activity/Functioning scale has three-point ('Able to do on own without difficulty'/'Able to do on own with difficulty'/'Unable to do on own') response options. Reduction in score denotes improved heath status.|Baseline and Week 8|One subject was missing a questionnaire page of the CAMPHOR; Therefore, the component score of|||units on a scale||Standard Deviation|Mean
2811664|NCT00439946|Secondary|Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.|Week 8||||minutes||Standard Deviation|Mean
2811665|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
2811666|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
2811667|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
2811668|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included|||participants|||Number
2811669|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included|||participants|||Number
2811670|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included|||participants|||Number
2811671|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
2811672|NCT00439946|Secondary|Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification|WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.|||participants|||Number
2811673|NCT00439946|Secondary|Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Week 8|Two subjects did not have Baseline Borg scores and were excluded from this analysis.|||units on a scale||Standard Deviation|Mean
2811674|NCT00439946|Primary|Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)|The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].|Week 8|Two subjects did not have Baseline 6MWTs and were excluded from this analysis.|||meters||Standard Deviation|Mean
2811723|NCT00439647|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.|||Percent change in BMD||Standard Error|Least Squares Mean
2811675|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811676|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811677|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811678|NCT00439777|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811679|NCT00439777|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811680|NCT00439777|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811689|NCT00439777|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811681|NCT00439777|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.|||Percentage of participants|||Number
2811682|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811683|NCT00439777|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
2811684|NCT00439777|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
2811685|NCT00439777|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.|||Percentage of participants|||Number
2811686|NCT00439777|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811687|NCT00439777|Secondary|Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811688|NCT00439777|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811690|NCT00439777|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811691|NCT00439738|Secondary|Change From Baseline in Postprandial Non-esterified Fatty Acids|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis|||mg/dL||Standard Deviation|Mean
2811692|NCT00439738|Secondary|Change From Baseline in Postprandial Insulin|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis|||mg/dL||Standard Deviation|Mean
2811693|NCT00439738|Secondary|Change From Baseline in Postprandial Glucose|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis.|||mg/dL||Standard Deviation|Mean
2811694|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg|Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)|||participants|||Number
2811695|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg|Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)|||participants|||Number
2811696|NCT00439738|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline to Weeks 4, 8, 12 and 16|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2811697|NCT00439738|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline to Week 8|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
2811698|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811699|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811700|NCT00439725|Other Pre-specified|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period|Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units, occurring in a critical site or contributing to death.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811701|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811702|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811704|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811705|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811706|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811707|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811708|NCT00439725|Secondary|Percentage of Participants With Other Vascular Events|All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
2811709|NCT00439725|Secondary|Percentage of Participants With All Death|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
2811710|NCT00439725|Secondary|Percentage of Participants With Clinically Relevant Bleeding|All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
2811711|NCT00439725|Secondary|Percentage of Participants With Major Bleeding|All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.|||Percentage of participants|||Number
2811712|NCT00439725|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811713|NCT00439725|Secondary|Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811714|NCT00439725|Secondary|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811715|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811716|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811717|NCT00439725|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||Percentage of participants|||Number
2811718|NCT00439673|Secondary|Time to Transformation to AML||At 60 months||||months||95% Confidence Interval|Median
2811719|NCT00439673|Primary|The Primary Objective of the Trial is to Assess the Efficacy of the Combined Use of Valproic Acid (VPA) in Combination With 5-Azacytidine (5-Aza C) in the Treatment of MDS.|Overall survival|At 60 months||||months||95% Confidence Interval|Median
2811720|NCT00439647|Secondary|Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits||Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24|The ITT, Intent to Treat population, includes all participants who received a single a dose of treatment and had data available for analysis. n = the number of subjects with evaluable measurements at visit, as determined by the efficacy window.|||ng/mL||Standard Error|Mean
2811721|NCT00439647|Secondary|Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.|||Percent change in BMD||Standard Error|Least Squares Mean
2811722|NCT00439647|Secondary|Percentage Change From Baseline in Total Hip BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.|||Percent change in BMD||Standard Error|Least Squares Mean
2811724|NCT00439647|Secondary|Number of Participants With First Non-vertebral Fracture|Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.|||Participants|||Number
2811726|NCT00439647|Secondary|Number of Participants With First Clinical Vertebral Fracture|Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.|||Participants|||Number
2811727|NCT00439647|Secondary|Mean Change in Height From Baseline|Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis|from Baseline to 12 months and 24 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||mm||Standard Error|Mean
2811728|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, Month 24|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.|||Percentage of Participants|||Number
2811729|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, 12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of Participants|||Number
2811730|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of participants|||Number
2811731|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of participants|||Number
2811732|NCT00439647|Secondary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|12 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.|||Percentage of participants|||Number
2811733|NCT00439647|Primary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.|||Percentage of Participants|||Number
2811734|NCT00439608|Secondary|Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.|CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.|baseline, then during treatment, about 5 weeks through 30 days post treatment.|60 patients were analyzed for toxicity but 57 for overall response.|||participants|||Number
2811735|NCT00439608|Primary|Reponse Rate at Time of Surgery by Tissue|pathologic complete response rate at surgery|within 30 days of last treatment||||participants|||Number
2811738|NCT00439569|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Change in SMN Protein level||Standard Deviation|Mean
2811739|NCT00439569|Secondary|Pharmacokinetic Parameters (Time to Maximum Concentration)|Time to Maximum Concentration (Tmax)|12 weeks||||Hours||Standard Deviation|Mean
2811740|NCT00439569|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks||||µM||Standard Deviation|Mean
2811741|NCT00439569|Secondary|Drug Safety|Adverse event(AE)monitoring|14 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the study monitoring committee (SMC).|||Adverse Events|||Number
2811742|NCT00439569|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Change in mRNA level||Standard Error|Mean
2811743|NCT00439569|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade (GR)3 or higher adverse event(AE),GR 1 or higher cardiac arrhythmia;GR 2 or higher vomiting;GR 2 or higher liver dysfunction/failure (clinical);GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis.The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor:decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT,bilirubin;abnormality of Na, K, Cl, Ca, HCO3, glucose, BUN or creatinine.|29 Days|The study was closed prematurely due to poor compliance with study drug administration. The MTD could not be determined as it was less than the lowest dosage studied (500 mg/kg/day).|||DLT(s)|||Number
2811744|NCT00439556|Primary|Disease-free Survival|To determine DFS at 1 year post transplant.|At 1 year|Patients up to 70 years of age with any histological subtype of CD20+ lymphoid malignancy or T-Cell lymphoid malignancy who were not eligible for a non-myeloablative transplant.|||Participants|||Count of Participants
2811745|NCT00439556|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|To determine the maximum tolerated dose(MTD) of velcade and dose limiting toxicity(DLT). A dose limiting toxicity (DLT) was defined as a grade 3-4 neurological toxicity, graft failure, or death due to GvHD. The Commom Terminlogy Criteria for Adverse Events v3.0 was used.|From start of treatment to 90 days after the start of treatment|Patients up to 70 years of age with any histological subtype of CD20+ lymphoid malignancy or T-Cell lymphoid malignancy who were not eligible for a non-myeloablative transplant.|||Participants|||Count of Participants
2811746|NCT00439517|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Safety population|||participants|||Number
2811747|NCT00439517|Secondary|Treatment Impact on Social Daily Living and Health Care Resource Utilization|Non-protocol medical care visits and consultations|From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009|ITT population|||visits or consultations|||Number
2811748|NCT00439517|Secondary|QOL Therapy Preference Questionnaire (TPQ)|TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|"Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.~The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles"|||percentage of participants|||Number
2811749|NCT00439517|Secondary|QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire|The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.|||scores on a scale||Standard Error|Least Squares Mean
2811750|NCT00439517|Secondary|Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|"All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0=Not at all to 4=Very much. For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL."|At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2811751|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011|ITT population i.e. all randomized subjects.|||months||95% Confidence Interval|Median
2811752|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.|||months||95% Confidence Interval|Median
2811753|NCT00439517|Secondary|Best Overall Response (BOR)|"BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later"|Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.|||percentage of participants||95% Confidence Interval|Number
2811754|NCT00439517|Primary|Progression-free Survival (PFS)|Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria|Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Intention-to-treat (ITT) population i.e. all randomized subjects .|||months||95% Confidence Interval|Median
2811755|NCT00439465|Secondary|Determine the Methods of Tumor Cell Killing of the in Vivo CD8+ Cells: Cytotoxicity Assays, Blocking Experiments, Analysis of T-cell Receptor (TCR)|We will isolate the CD8+ populations (CD3+CD8+, CD8+CD56+) using the Auto MACS (Miltenyi) and then identify the mechanisms of tumor cell killing by the CD8+ cells obtained pre-transplant (Baseline) and following the third and fourth cellular infusions. We will examine mechanisms of tumor cell killing through NKG2D receptor, major histocompatibility complex (MHC) Class I molecules or through the T cell receptor. We postulate the CD8+ cells obtained from patient's blood will kill tumor cells both via MHC Class I and through the NKG2D receptor.|Pre-transplant and following the third and fourth cellular infusions.|Autologous myeloma cells were isolated for only 4 study participants. There is no information on the remaining participant provided.|||Participants|||Count of Participants
2811756|NCT00439465|Secondary|Number of Participants With Increased Expression of DAP10 and NKG2D on the CD8 Cell Population|"Isolate CD3+CD8+ and CD8+CD56+ from patients' blood following transplant.~Identify NKG2D and DAP10 expression.~Determine the mechanism of tumor cell killing and the relationship to NKG2D or DAP 10 expression.~After isolating CD8+ cells from patient's blood samples using the AutoMACS, we will evaluate the expression of NKG2D and DAP10 on all CD8+ cells (CD3+CD8+ and CD8+CD56+cells) pre-transplant (Baseline) and following the third and fourth cellular infusions using phenotypic analysis. We postulate the increased expression of both DAP10 and NKG2D on the CD8 population immediately following APSCT and effector cell infusions when compared to baseline."|Pre-transplant and following the third and fourth cellular infusions|Sixteen out of nineteen participants samples were analyzed. Three participants' samples were not available for analysis.|||Participants|||Count of Participants
2811757|NCT00439465|Secondary|Assessment of Disease Response to Treatment|To establish the disease response of myeloma patients treated with high dose melphalan, APBSCT& adoptive transfer of cytotoxic effector cells with IL-2 and GM-CSF.|From initiation of treatment on protocol until Day 100||||Participants|||Count of Participants
2811758|NCT00439465|Secondary|Time to Recovery of Platelet Count|To establish the time to engraftment of myeloma patients treated with high dose melphalan, APBSCT& adoptive transfer of cytotoxic effector cells with IL-2 and GM-CSF.|From initiation of treatment on protocol until Day 100||||days||Full Range|Median
2811759|NCT00439465|Secondary|Time to Recovery of Absolute Neutrophil Count|To establish the time to engraftment of myeloma patients treated with high dose melphalan, APBSCT& adoptive transfer of cytotoxic effector cells with IL-2 and GM-CSF.|From initiation of treatment on protocol until Day 100||||Days||Full Range|Median
2811760|NCT00439465|Secondary|Count of Participants With Increased CD3+CD8+, CD8+ and CD56+ Concentrations Between Day 15 Post-Transplant and Days 21 to 28 Post-transplant|"To demonstrate that the effector cell infusions result in a clinical effect, phenotypic analyses of blood samples using flow cytometry will be performed prior to, and after each infusion, focusing on the CD8 + populations (CD3+CD8+, CD8+CD56+). As a complement to flow cytometry, the following assays will be used to identify cell subset precursor frequencies, subset proliferation, and cytokine production:~Dye Dilution Proliferation Assay (DDPA) 36 - Evaluation of CD8+ T Cell Precursors~ELISPOT-Quantifying cytokine producing T cells:"|Day 15 post-transplant and between days 21 to 28 post-transplant|Sixteen out of nineteen subject samples were analyzed. Three subject's samples were not available for analysis.|||Participants|||Count of Participants
2811761|NCT00439465|Primary|Number of Participants With Adverse Events in All Subjects|To establish the safety (toxicity) of myeloma patients treated with high dose melphalan, autologous peripheral blood stem cell transplantation (APBSCT) & adoptive transfer of cytotoxic effector cells with Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF).|From initiation of treatment on protocol until Day 100||||Participants|||Count of Participants
2811762|NCT00439413|Secondary|Abstinence|The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.|week 14||||participants|||Number
2811763|NCT00439413|Primary|Quit Rate|The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).|Study weeks 6 through 9||||participants|||Number
2811767|NCT00439374|Secondary|Number of Neonates With Patent Ductus Arteriosus|Number of neonates diagnosed with the heart defect patent ductus arteriosus|Delivery through neonatal discharge|Data was missing for 7 participants in the treatment group and 8 participants in the placebo group.|||Participants|||Count of Participants
2811768|NCT00439374|Secondary|Number of Neonates With a Major Congenital Anomaly|Presence of a major congenital anomaly at birth|Delivery|Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.|||Participants|||Count of Participants
2811769|NCT00439374|Secondary|Number of Participants With Apgar Score of Less Than 7 at 5 Minutes|The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.|5 minutes post delivery|Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.|||Participants|||Count of Participants
2811770|NCT00439374|Secondary|Number of Neonates Who Measured Small for Gestational Age|Birth weight percentile and small for gestational age <10th percentile based on number of weeks and gender.|Delivery|Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.|||Participants|||Count of Participants
2811771|NCT00439374|Secondary|Birth Weight by Count of Participants|Birth weight by count of participants < 2500 grams and < 1500 grams|Delivery|Data was missing for 4 participants in the treatment group and 2 participants in the placebo group.|||Participants|||Count of Participants
2811772|NCT00439374|Secondary|Mean Birth Weight|Birth weight as measured in grams|Delivery||||Grams||Standard Deviation|Mean
2811773|NCT00439374|Secondary|Number of Participants Meeting the Composite Adverse Perinatal Outcome and Components|comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis|within 72 hours of delivery|With the exception of the composite outcome and death, the neonatal outcomes were only measured for live births.|||Participants|||Count of Participants
2811774|NCT00439374|Secondary|Number of Participants Who Reported Side Effects|Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site|Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 1 participant in the treatment group and 2 participants in the placebo group.|||Participants|||Count of Participants
2811775|NCT00439374|Secondary|Number of Participants Who Had Cesarean Delivery||delivery|Data was missing for 1 participant in the placebo group.|||Participants|||Count of Participants
2811776|NCT00439374|Secondary|Number of Participants Who Experienced Chorioamnionitis||Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 2 participants in the placebo group.|||Participants|||Count of Participants
2811777|NCT00439374|Secondary|Number of Participants Who Experienced Placental Abruption||Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 2 participants in the placebo group.|||Participants|||Count of Participants
2811778|NCT00439374|Secondary|Number of Participants Experiencing Cholestasis||Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 1 participant in the Placebo group|||Participants|||Count of Participants
2811779|NCT00439374|Secondary|Number of Participants With Gestational Diabetes Mellitus||Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks||||Participants|||Count of Participants
2811780|NCT00439374|Secondary|Number of Participants Experiencing Gestational Hypertension or Preeclampsia||Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 1 participant in the placebo group.|||Participants|||Count of Participants
2811781|NCT00439374|Secondary|Number of Participants Who Had a Cerclage Placement|Number of participants who had a cerclage placement|Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.|||Participants|||Count of Participants
2811782|NCT00439374|Secondary|Number of Participants Who Underwent Corticosteroid Therapy|Number of participants who underwent corticosteroid therapy in pregnancy|Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.|||Participants|||Count of Participants
2811783|NCT00439374|Secondary|Number of Participants Who Underwent Tocolytic Therapy|Number of participants who underwent tocolytic therapy during pregnancy|Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks|Data was missing for 6 participants in the treatment group and 5 participants in the placebo group.|||Participants|||Count of Participants
2811784|NCT00439374|Secondary|Number of Participants Who Visited the Hospital Due to Preterm Labor|Number of participants who visited the hospital due to preterm labor before 37 weeks gestation|Between randomization and 37 weeks gestation||||Participants|||Count of Participants
2811785|NCT00439374|Secondary|Number of Participants Who Delivered Before 28 Weeks Gestation|Delivery before 28 weeks gestation|Delivery||||Participants|||Count of Participants
2811786|NCT00439374|Secondary|Number of Participants Who Delivered Before 32 Weeks Gestation|Delivery before 32 weeks gestation|Delivery||||Participants|||Count of Participants
2811787|NCT00439374|Secondary|Number of Participants Who Delivered Before 35 Weeks Gestation|Delivery before 35 weeks gestation|Delivery||||Participants|||Count of Participants
2811788|NCT00439374|Secondary|Number of Participants With Preterm Premature Rupture of Membranes||<37 weeks||||Participants|||Count of Participants
2811789|NCT00439374|Secondary|Mean Gestational Age at Delivery|Mean gestational age at delivery|Delivery||||weeks||Standard Deviation|Mean
2811791|NCT00439335|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination||||Participants|||Number
2811792|NCT00439335|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination||||Participants|||Number
2811793|NCT00439335|Primary|Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Through approximately Day 56||||Participants|||Number
2811794|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 7 months after receipt of the first dose of vaccine.|Approximately Day 208||||Participants|||Number
2811795|NCT00439335|Secondary|HAI GMT at 7 Months After Dose 1|HAI GMT against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208||||Antibody Titer||95% Confidence Interval|Geometric Mean
2811796|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208||||Participants|||Number
2811797|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose of vaccine.|Approximately Day 28||||Participants|||Number
2811798|NCT00439335|Secondary|HAI GMT After Dose 1|HAI GMT against influenza A/H5N1 virus one month after receipt of the first dose of vaccine.|Approximately Day 28||||Antibody titer||95% Confidence Interval|Geometric Mean
2811799|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose.|Approximately Day 28||||Participants|||Number
2811800|NCT00439335|Secondary|Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine|Approximately Day 56||||Participants|||Number
2811801|NCT00439335|Secondary|HAI Geometric Mean Titer (GMT) After Dose 2|HAI geometric mean titer (GMT) against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine.|Approximately Day 56.||||Antibody Titer||95% Confidence Interval|Geometric Mean
2811802|NCT00439335|Primary|Number of Participants Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|Through Day 208.||||Participants|||Number
2811803|NCT00439335|Primary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2|Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine|Approximately Day 56.||||Participants|||Number
2811804|NCT00439309|Secondary|Time to Wound Closure|Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.|From initial clamp removal at the last anastomotic site until skin closure||||Minutes||95% Confidence Interval|Median
2811805|NCT00439309|Secondary|Time to Hemostasis|Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.|Within 10 minutes post restoration of blood flow||||Minutes||95% Confidence Interval|Median
2811806|NCT00439309|Secondary|Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.|Within 10 minutes post restoration of blood flow||||percentage of anastomitic sites|Anastomosis||Number
2811807|NCT00439309|Secondary|Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow|60 seconds post restoration of blood flow||||percentage of anastomotic sites|Anastomosis||Number
2811808|NCT00439309|Primary|Sealing Success|The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.|Within 10 minutes following restoration of blood flow|The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.|||percentage of participants||95% Confidence Interval|Number
2811809|NCT00439270|Secondary|Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests|ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.|From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
2811810|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel||Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose|All patients who received at least 1 dose of dasatinib|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2811811|NCT00439270|Secondary|Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel||Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2811812|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel||Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2811813|NCT00439270|Secondary|Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Participants|||Number
2811814|NCT00439270|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All participants who received at least 1 dose of dasatinib|||Participants|||Number
2811815|NCT00439270|Secondary|Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6|The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.|At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.|||Units on a scale||Full Range|Median
2811816|NCT00439270|Secondary|Percentage of Participants With Improvement on Bone Scan|Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Percentage of participants||95% Confidence Interval|Number
2811817|NCT00439270|Secondary|Number of Participants by Best On-study Bone Scan Assessment From Baseline|Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Participants|||Number
2811818|NCT00439270|Primary|Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2|Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1|||mg|||Number
2811819|NCT00439270|Secondary|Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR.~PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present.~To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change."|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Participants|||Number
2811820|NCT00439270|Secondary|Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Percentage of participants||95% Confidence Interval|Number
2811821|NCT00439270|Secondary|Number of Months of Progression-free Survival (PFS)|"PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following:~tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status."|Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Months||95% Confidence Interval|Median
2811822|NCT00439270|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment|All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m^2 and who had a PSA response|||Months||95% Confidence Interval|Median
2811823|NCT00439270|Primary|Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel|MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1|||mg|||Number
2811824|NCT00439270|Secondary|Percentage of Participants With a Prostate Specific Antigen (PSA) Response|PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2|||Percentage of participants||95% Confidence Interval|Number
2811825|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)|Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window|||ng/mL||Standard Deviation|Mean
2811840|NCT00439179|Primary|Toxicity (Number of Patients Who Experiened DLTs)|To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs|until death, approximately 2 years||||participants|||Number
2811826|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)|Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window|||ng/mL||Standard Deviation|Mean
2811827|NCT00439244|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52|BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13, Week 26 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.|||Percent Change||Standard Error|Least Squares Mean
2811828|NCT00439244|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13 and Week 26|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.|||Percent Change||Standard Error|Least Squares Mean
2811829|NCT00439244|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data.|||Percent change||Standard Error|Least Squares Mean
2811830|NCT00439231|Primary|To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen|To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen|24 weeks of lenalidomide therapy||||participants|||Number
2811831|NCT00439218|Secondary|Overall Study Drug Compliance|Subjects receiveing 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 weeks|A total of 5 participants were enrolled in the study. Four enrolled in Cohort 1.|||Participants|||Number
2811832|NCT00439218|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area under the plasma concentration versus time curve (AUC)|12 weeks||||µmol/L * hours||Standard Deviation|Mean
2811833|NCT00439218|Secondary|Pharmacokinetic Parameters (Time to Maximum Plasma Concentration)|Time to maximum plasma concentration (Tmax)|12 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Hours||Standard Deviation|Mean
2811834|NCT00439218|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks||||µM||Standard Deviation|Mean
2811835|NCT00439218|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 Weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||SMN/beta tubulin||Standard Deviation|Mean
2811836|NCT00439218|Secondary|Drug Safety|Adverse event (AE) monitoring|14 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the SMC.|||Adverse Events|||Number
2811837|NCT00439218|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.|||Cycle Threshold (Ct)||Standard Error|Mean
2811838|NCT00439218|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade(GR)3 or higher adverse event, GR 1 or higher cardiac arrhythmia; GR 2 or higher vomiting; GR 2 or higher liver dysfunction/failure (clinical); GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis. The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor: decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT, bilirubin; abnormlity of Na, K, Cl, CA, HCO3, glucose, BUN, creatinine.|29 days|The study was closed prematurely due to slow accrual. The MTD could not be determined due to the small number of subjects enrolled.|||DLT(s)|||Number
2811839|NCT00439179|Secondary|Number of Patients Who Experienced a Partial Response|To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.|every two months until progression||||participants|||Number
2811858|NCT00438932|Primary|Fibroblast Growth Factor 23 (FGF-23)|Plasma FGF-23 was measured using c-terminal FGF23 assay.|2 weeks||||RU/ml||Standard Error|Mean
2811841|NCT00439140|Other Pre-specified|Number of Participants With at Least a 20% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.|||Participants|||Number
2811842|NCT00439140|Other Pre-specified|Number of Participants With at Least a 15% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.|||Participants|||Number
2811843|NCT00439140|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).|Baseline, Week 6|Intent-to-treat population included all randomized participants.|||mL||Standard Deviation|Mean
2811844|NCT00439140|Secondary|Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)|MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).|Baseline, Week 6|Intent-to-treat population included all randomized participants.|||cm H2O||Standard Deviation|Mean
2811845|NCT00439140|Secondary|Change From Baseline in the Number of Urinary Incontinence Episodes|The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).|Baseline, Week 6|Participants from the Intent-to-treat population (all randomized participants) using observed data for analysis.|||Episodes||Standard Deviation|Mean
2811846|NCT00439140|Primary|Change From Baseline in FEV1/FVC Ratio|The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.|||Ratio||Standard Deviation|Mean
2811847|NCT00439140|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.|||Liters||Standard Deviation|Mean
2811848|NCT00439140|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety Population included all randomized participants who received treatment.|||Liters||Standard Deviation|Mean
2811849|NCT00438971|Other Pre-specified|Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas.|8 weeks||||units on a scale||Standard Deviation|Mean
2811850|NCT00438971|Other Pre-specified|Sheehan Disability Scale (SDS)|The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment.|8 weeks||||units on a scale||Standard Deviation|Mean
2811851|NCT00438971|Other Pre-specified|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items.|8 weeks||||units on a scale||Standard Deviation|Mean
2811852|NCT00438971|Other Pre-specified|Beck Anxiety Inventory (BAI)|The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity.|8 weeks||||units on a scale||Standard Deviation|Mean
2811853|NCT00438971|Other Pre-specified|Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.|8 weeks||||units on a scale||Standard Deviation|Mean
2811854|NCT00438971|Secondary|Panic Attack Scale (PAS)|The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score.|8 weeks||||units on a scale||Standard Deviation|Mean
2811855|NCT00438971|Secondary|Clinical Global Impression of Severity Scale (CGI-S)|The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint.|8 weeks||||units on a scale||Standard Deviation|Mean
2811856|NCT00438971|Primary|Panic Disorder Severity Scale (PDSS)|The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.|8 weeks||||units on a scale||Standard Deviation|Mean
2811857|NCT00438932|Secondary|24-hour Urinary Phosphate|from 24-hr urine collections|2 weeks||||mg||Standard Error|Mean
2811859|NCT00438880|Secondary|Duration of Response|Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.|Up to 1 year from treatment start date|The duration of response was not analyzed due to a lack of more than one response.||||||
2811860|NCT00438880|Secondary|Progression-free Survival|The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.|Up to 1 year from treatment start date|Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.|||months||95% Confidence Interval|Median
2811861|NCT00438880|Primary|Tumor Response|"Complete Response (CR):~No measurable or nonmeasurable disease.~No symptoms of Lymphoma.~Non-palpable spleen, if palpable at baseline.~Histologically negative bone marrow, if positive at baseline.~All nodes <1.5 cm in transverse diameter.~Partial Response (PR):~greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions.~No new lesions~We are reporting the number of participants that attained a status of CR or PR."|Evaluations occur every three months up to a year|Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.|||participants|||Number
2811862|NCT00438880|Primary|Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level|"Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following:~Absolute neutrophil counts or platelet counts below 10*10^9/L for 14 days~Absolute neutrophil counts greater than 0.5 or less than 1*10^9/L~Platelet counts greater than 10 or less than 50*10^9/L for 28 days.~Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.~We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity."|at least 10 weeks post treatment up to 3 months.|Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.|||participants|||Number
2811863|NCT00438854|Secondary|Median Overall Survival|The median survival time, as measured from the start of treatment until death from any cause.|3 years||||Months||Full Range|Median
2811864|NCT00438854|Secondary|Median Time to Disease Progression|The median time to disease progression, measured from the start of treatment.|1 year||||Months||Full Range|Median
2811865|NCT00438854|Secondary|Complete Response Rate|The number of participants with a 100% reduction in nodal mass.|1 year||||Participants|||Count of Participants
2811866|NCT00438854|Primary|Overall Objective Response|"Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria):~Complete response (CR) requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Normal complete blood count~Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease~Partial response (PR): requires at least the following:~50% decrease in peripheral blood lymphocyte count~50% reduction in lymphadenopathy~50% reduction in the size of the liver and/or spleen"|2 years||||participants who responded|||Number
2811867|NCT00438815|Primary|Percent of HAE Attacks With Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. The conservative analysis defined substantial relief as 3 consecutive assessments of improvement of the defining symptom; any attack that did not have 3 consecutive documented reports of improvement was considered a treatment failure. In the less conservative analysis, attacks also were considered to have responded if clinical improvement of the defining symptom occurred but data were incomplete due to cessation of symptom assessments.|Within 4 hours after initial treatment|ITT-E Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).|||percent of attacks|||Number
2811868|NCT00438815|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=74).|||mg/dL||Standard Deviation|Mean
2811869|NCT00438815|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=82).|||percent of functional C1INH||Standard Deviation|Mean
2811870|NCT00438815|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=84).|||mg/dL||Standard Deviation|Mean
2811871|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom for Subjects Who Received Multiple Treatments|For attack number 1, the number of censored observations precluded estimation of the 95% confidence interval (CI) upper bound for median time to event (subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations). Entry of 4.0 hours indicates that data were not estimable (NE); as non-numeric data are not supported by the 95% CI field, entry of the actual result (ie, NE or >4.0) was not possible.|Within 4 hours after initial treatment|ITT-E subjects with at least 10 HAE attacks during the study (N=15).|||hours||95% Confidence Interval|Median
2811872|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-E Population.|||hours||95% Confidence Interval|Median
2811874|NCT00438802|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.|8 weeks from registration|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.|||mg/kg Alefacept|||Number
2811875|NCT00438802|Secondary|Clinical Response|"Treatment response and evaluation will be performed using standardized lymphoma International Working Group recommendations. >~> A Complete Response (CR) requires: >~Complete disappearance of all detectable clinical and radiographic evidence of > disease. >~All lymph nodes and nodal masses must have regressed to normal size. >~Partial Response (PR): >~greater than 50% decrease in Sum of Product Dimensions of the six largest dominant nodes, nodal masses, or skin lesions. >~No increase in size of other nodes >~no new sites of disease."|up to 12 cycles (28 days per cycle) of treatment.|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.|||participants|||Number
2811876|NCT00438802|Primary|Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment. >~> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: >~grade 4 toxicity for neutrophils (<0.5 x 109/L) or platelets (<25 x 109/L) >~any grade 3 or higher solid organ toxicity not explainable by another obvious cause. >~more than 10 x ULN AST toxicity for more than 14 days >~any grade 4 infection. >~The number of patients who reported a dose limiting toxicity is reported here."|8 weeks from registration|Two patients from Dose level 2 were not able to complete cycle 1 and were not evaluated for dose limiting toxicity.|||Participants|||Count of Participants
2811877|NCT00438750|Secondary|Grip Strength|Measured with use of a grip meter as the average of three attempts.|6 months||||Pounds (lbs)||Standard Deviation|Mean
2811878|NCT00438750|Secondary|Mayo Wrist Score|A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.|6 months||||units on a scale||Standard Deviation|Mean
2811879|NCT00438750|Secondary|Gartland and Werley Score|An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.|6 months||||units on a scale||Standard Deviation|Mean
2811880|NCT00438750|Secondary|Pinch Strength|"Pinch strength measured with the B&L pinch gauge.~B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym)."|6 months||||Pounds (lbs)||Standard Deviation|Mean
2811881|NCT00438750|Secondary|10-point Ordinal Pain Scale|A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.|6 months||||units on a scale||Standard Deviation|Mean
2811882|NCT00438750|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.~Mean and standard deviations are identical for both arms."|6 months||||units on a scale||Standard Deviation|Mean
2811883|NCT00438750|Primary|Range of Motion in Degrees of the Wrists|"Mean arc of wrist flexion and extension six months after surgery.~Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees."|6 months||||Degrees||Standard Deviation|Mean
2811884|NCT00438672|Primary|Visual Analog Scale for Pain|Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.|6 months||||units on a scale||Standard Deviation|Mean
2811885|NCT00438672|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|6 months||||units on a scale||Standard Deviation|Mean
2811886|NCT00438659|Secondary|Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).|Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)|During Radiation Treatment, up to a maximum of 11 weeks.||||units on a scale||Standard Deviation|Mean
2811887|NCT00438659|Secondary|Adverse Events Assessed Clinically by NCI CTCAE v3.0||During Radiation Treatment, up to a maximum of 9 weeks.||||participants|||Number
2811888|NCT00438659|Secondary|QOL Domains as Measured by LASA|Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.|||units on a scale||Standard Deviation|Mean
2811889|NCT00438659|Secondary|Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)|Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.|||units on a scale||Standard Deviation|Mean
2811890|NCT00438659|Secondary|Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.|To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.|During Radiation Treatment, up to a maximum of 9 weeks.|This analysis was not completed due to too little incidence of the dermatitis.||||||
2811891|NCT00438659|Secondary|Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).|Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).|During Radiation Treatment, up to a maximum of 11 weeks.||||score on a 0-6 scale||Standard Deviation|Mean
2811892|NCT00438659|Secondary|Skin Toxicity as Measured by the Skin Toxicity Assessment Tool|Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.|During Radiation Treatment, up to a maximum of 9 weeks.||||Score on a 0 to 5 scale||Standard Deviation|Mean
2811893|NCT00438659|Secondary|Incidence of Severe ( Grade >=3) Radiation Dermatitis|To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.|During Radiation Treatment, up to a maximum of 9 weeks.||||Paticipants|||Number
2811894|NCT00438659|Primary|Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.|Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).|During Radiation Treatment, up to a maximum of 9 weeks.||||Grade||Full Range|Mean
2811895|NCT00438633|Secondary|Disability of the Hand, Shoulder, and Arm Score|Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.|3 months, 6 months|All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.|||Units on a scale||Standard Deviation|Mean
2811896|NCT00438633|Secondary|Abduction||3 months, 6 months|All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.|||Degrees||Standard Deviation|Mean
2811897|NCT00438633|Secondary|External Rotation||3 months, 6 months|All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.|||Degrees||Standard Deviation|Mean
2811898|NCT00438633|Secondary|Shoulder Pain Likert Scores|Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.|3 months, 6 months|All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.|||units on a scale||Standard Deviation|Mean
2811899|NCT00438633|Primary|Shoulder Flexion|We measured active forward flexion of the shoulder|6 months|All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.|||Degrees||Standard Deviation|Mean
2811900|NCT00438490|Secondary|Estradiol||7 days||||pmol/L||Standard Error|Mean
2811901|NCT00438490|Secondary|Menstrual Cycle Length||28 days||||Days||Standard Error|Mean
2811902|NCT00438490|Secondary|N-telopeptide||7 days||||nM/mM||Standard Error|Mean
2811903|NCT00438490|Primary|Galactorrhea|Galactorrhea is breast milk production.|7 days||||percentage of participants|||Number
2811904|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Full Range|Median
2811905|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Full Range|Median
2811906|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
2811907|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
2811917|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)|Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||cubic centimeter||Full Range|Median
2811908|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
2811909|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Standard Deviation|Mean
2811910|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage of tumor cell involvement||Full Range|Median
2811911|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.|||Percentage tumor cell involvement||Full Range|Median
2811912|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
2811913|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
2811914|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
2811915|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
2811916|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)|Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||percentage of change||Full Range|Median
2811918|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy|Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.|||participants|||Number
2811919|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus|Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
2811920|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)|Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
2811921|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci|Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
2811922|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status|Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
2811923|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)|Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.|||participants|||Number
2811924|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage|American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.|Assessment following maximum 6 week treatment period and prostatectomy|All evaluable participants.|||participants|||Number
2811925|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)|Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.|||participants|||Number
2811926|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.|||participants|||Number
2811927|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.|||participants|||Number
2811928|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)|"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened"|week 58|Patients of ITT population with data at V6 and V0|||participants|||Number
2811930|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6|EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.|week 58|Patients of ITT population who had data at V6|||units on a scale||Standard Deviation|Mean
2811931|NCT00438451|Secondary|Portland Neurotoxicity Scale (PNS) at V6|"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life."|at week 58|Patients of ITT population who filled out PNS at V6|||units on a scale||Standard Deviation|Mean
2811932|NCT00438451|Secondary|QOLIE-31 (Quality Of Life In Epilepsy) Results at V6|The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.|58 weeks, final visit|Patients of ITT population who filled out QOLIE-31 at V6|||units on a scale||Standard Deviation|Mean
2811933|NCT00438451|Secondary|Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase||52 weeks|Patients of ITT population who reached the maintenance phase|||proportion of seizure-free days|||Number
2811934|NCT00438451|Secondary|The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)|"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries."|over 52 weeks|"Completer population:~The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment)."|||number of seizures|||Number
2811935|NCT00438451|Secondary|The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)||over the whole duration of 58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||days||95% Confidence Interval|Median
2811936|NCT00438451|Secondary|Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)|Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.|week 58|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||percentage of participants|||Number
2811937|NCT00438451|Secondary|Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)|Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.|Week 30|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||percentage of participants|||Number
2811938|NCT00438451|Secondary|Time to Drop Out|number of days between randomization and premature discontinuation of the study|58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||days||95% Confidence Interval|Median
2811939|NCT00438451|Primary|58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment||58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."|||proportion of participants||95% Confidence Interval|Mean
2811940|NCT00438399|Primary|Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator|"Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: C. propionate shampoo a lot better than the comparator,C. propionate shampoo a lillte bit better than the comparator, Comparator a lot better than C. propionate shampoo, Comparator a lillte bit better than C. propionate shampoo. This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population."|End of period II (up to 16 weeks)|Intent to Treat population (ITT).|||Percentage of participants|||Number
2811941|NCT00438360|Secondary|Safety / Tolerability Assessed by Adverse Events||24weeks|||||||
2811942|NCT00438360|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline and week 24|Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis.|||Units on a scale||Standard Deviation|Mean
2811943|NCT00438360|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( [Height(in) x Weight(lbs) ]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed|Baseline and week 24|Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis.|||BSA (m^2)||Standard Deviation|Mean
2815184|NCT00418262|Primary|Pittsburg Side-Effects Scale: Tearful/Sad/Depressed|"Tearful/Sad/Depressed~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in RCT did not participate in the open label study|||units on a scale||Standard Deviation|Mean
2811944|NCT00438360|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.|baseline and week 24|Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis.|||Units on a scale||Standard Deviation|Mean
2811945|NCT00438360|Secondary|Proportion of Participants With Clinical Relapse|Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) >75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.|24 weeks|Intent to treat population.|||proportion of participants|||Number
2811946|NCT00438360|Primary|Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score >75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was >= 75%. In all the other cases the patient was considered as success (no relapse).|24 weeks|Intent to treat population.|||Participants|||Number
2811947|NCT00438256|Secondary|Number of Participants With Treatment Related Serious Adverse Events|The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment.|From the start of treatment until 30 days after the end of treatment, up to approximately 5 months||||Participants|||Count of Participants
2811948|NCT00438256|Secondary|30-Day Post Operative Mortality|The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy.|30 days after the time of surgery (Surgery is 28-42 days after start of treatment)|The eligible participants who underwent surgical resection. The phase I arms and Phase II group were combined together for analysis.|||Participants|||Count of Participants
2811949|NCT00438256|Secondary|Number of Participants With Surgical Morbidity|Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery|30 days post surgery (surgery was 28-42 days after the start of treatment)|The eligible participants who underwent surgical resections. The phase I arms and Phase II group were combined together for analysis.|||Participants|||Count of Participants
2811950|NCT00438256|Secondary|Median Progression Free Survival|"The median amount of time from the start of treatment until death or disease progression, whichever occurs first.~Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline."|from the start of treatment until death or progression, median duration of 10.4 months|Two participants were excluded from the analysis because of ineligible final diagnoses (cholangiocarcinoma and autoimmune pancreatitis)|||Months||95% Confidence Interval|Median
2811951|NCT00438256|Secondary|Number of Participants With a Pathological Complete Response|All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.|at the time of surgery (28-42 days after start of treatment)|The eligible participants who underwent surgical resection. The phase I arms and Phase II group were combined together for analysis.|||Participants|||Count of Participants
2811952|NCT00438256|Primary|Number of Participants With Grade 3 or Greater Toxicity in Phase II|Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity.|30 days after the end of treatment, up to approximately 6 months total|Participants in the Phase II portion of the trial|||Participants|||Count of Participants
2811953|NCT00438256|Primary|Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm|"The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:~Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or~Any grade 4 non-hematologic toxicity or~Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)"|3 Weeks|The participants treated with radiation therapy at the 5 fractions over 5 consecutive days|||Participants|||Count of Participants
2811954|NCT00438204|Secondary|Overall Survival|Overall survival using the Kaplan-Meier method.|Every 8 weeks, for up to 54 months||||months||95% Confidence Interval|Median
2811955|NCT00438204|Secondary|Time to Treatment Failure|Time to treatment failure using the Kaplan-Meier method.|Every 8 weeks, for up to 54 months||||months||95% Confidence Interval|Median
2811956|NCT00438204|Secondary|Toxicity|Grade 3/4 toxicity according to the NCI Common Toxicity Criteria v3.0 .|Every two weeks, for up to 54 months||||Participants|||Count of Participants
2811957|NCT00438204|Secondary|Response Rate|The rate of response using RECIST criteria.|Every 8 weeks, for up to 54 months||||Participants|||Count of Participants
2811958|NCT00438204|Primary|Progression-free Survival (PFS)|RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|Up to 12 months||||months||90% Confidence Interval|Median
2811959|NCT00438191|Secondary|Pain Intensity|Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.|8 weeks||||units on a scale||Standard Deviation|Mean
2811968|NCT00437983|Secondary|Change From Baseline in Rey Osterrieth Complex Figure Test|A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).|baseline, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).|||Units on a scale||Standard Error|Mean
2811969|NCT00437983|Secondary|Clinical Global Impression of Change (CGI-C)Scale|"The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change. Global improvement score ranges from 1 = Very much improved, through 4 = No change, to 7 = Very much worse. Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)"|7 weeks, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).|||Participants who experienced improvement|||Number
2811970|NCT00437983|Secondary|Computerized Cognitive Assessment Tool||baseline, 15 weeks|||||||
2811971|NCT00437983|Secondary|Trail Making Test||Baseline, 15 weeks|||||||
2811972|NCT00437983|Secondary|Blood Work||baseline,15 wk|||||||
2811973|NCT00437983|Primary|Change From Baseline in Rey Auditory Verbal Learning Test|A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).|baseline, 15 wk|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn’t meet the compliance criteria (≥ 65%).|||number of words correctly recalled||Standard Error|Mean
2811974|NCT00437658|Secondary|Percentage of Participants Using Analgesics During the Treatment Phase|Analgesic use was collected as part of concomitant medications on a case report form that was administered at each scheduled visit.|24 weeks|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat).|||percentage of participants|||Number
2811975|NCT00437658|Secondary|Change From Baseline in EHP-5 Treatment Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811976|NCT00437658|Secondary|Change From Baseline in EHP-5 Medical Profession Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811977|NCT00437658|Secondary|Change From Baseline in EHP-5 Intercourse Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2812482|NCT00434356|Secondary|Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients|||participants|||Number
2811978|NCT00437658|Secondary|Change From Baseline in EHP-5 Relationship With Children Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811979|NCT00437658|Secondary|Change From Baseline in EHP-5 Work Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811980|NCT00437658|Secondary|Change From Baseline in EHP-5 Self Image Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811981|NCT00437658|Secondary|Change From Baseline in EHP-5 Social Support Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811982|NCT00437658|Secondary|Change From Baseline in EHP-5 Emotional Well-being Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811983|NCT00437658|Secondary|Change From Baseline in EHP-5 Control and Powerlessness Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811984|NCT00437658|Secondary|Change From Baseline in Endometriosis Health Profile-5 (EHP-5) Pain Dimension|"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2811985|NCT00437658|Secondary|Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain|"The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled no pain and the right extreme was labeled worst pain ever felt scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly mean VAS for pelvic pain defined as the average of all VAS pain scores reported for an individual participant from the previous visit to the day of the current scheduled visit.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811986|NCT00437658|Secondary|Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain|"The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled no pain and the right extreme was labeled worst pain ever felt scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly peak VAS for pelvic pain was defined as the maximum VAS pain score reported for an individual participant from the previous visit to the day of the current scheduled visit.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811987|NCT00437658|Secondary|Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Pelvic induration was assessed by the investigator based on findings associated with a pelvic examination.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811988|NCT00437658|Secondary|Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Pelvic tenderness was assessed by the investigator based on findings associated with a pelvic examination.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811989|NCT00437658|Secondary|Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days?.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811990|NCT00437658|Secondary|Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The dyspareunia score was based on the participant's response to the question Have you had painful intercourse during the last 28 days? Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811991|NCT00437658|Secondary|Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811992|NCT00437658|Secondary|Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS excluding dyspareunia has a maximum possible value of 12 (total score range: 0 to 12, where a lower score indicates less signs and symptoms of endometriosis or better functioning).~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811993|NCT00437658|Secondary|Change From Baseline in Total CPSSS During the Treatment Period|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning).~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|Baseline and weeks 4, 8, 12, 16, 20, and 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2811994|NCT00437658|Secondary|Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days? Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||percentage of participants|||Number
2811995|NCT00437658|Secondary|Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary VAS values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data at each time point.|||percentage of participants|||Number
2811996|NCT00437658|Secondary|Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24|"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days? Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and week 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary visual analog scale (VAS) values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data.|||percentage of participants|||Number
2811997|NCT00437658|Secondary|Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24|"The CPSSS consists of 5 components that address dysmenorrhea (pain during menstruation), dyspareunia (painful intercourse), non-menstrual pelvic pain, pelvic tenderness, and pelvic induration (hardening). Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline."|Baseline and week 24|All randomized participants who received at least one oral dose of study drug, an initial subcutaneous injection, and either reported at least 7 e-diary visual analog scale (VAS) values or provided an assessment of either dysmenorrhea or non-menstrual pelvic pain at week 4 or later during the treatment phase (intent-to-treat) with available data.|||percentage of participants|||Number
2811998|NCT00437658|Secondary|Change From Baseline in N-telopeptide at Weeks 12, 24 and 48|Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA). Change from baseline in N-telopeptide was analyzed using a one-way ANOVA model.|Baseline and weeks 12, 24 and 48|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point|||nM bone collagen equivalents (BCE)||Standard Error|Least Squares Mean
2811999|NCT00437658|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.|Baseline and weeks 12 and 48|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point|||percent change||95% Confidence Interval|Least Squares Mean
2812000|NCT00437658|Secondary|Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.|Baseline and weeks 12 and 48|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at each time point|||percent change||95% Confidence Interval|Least Squares Mean
2812001|NCT00437658|Primary|Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.|Baseline and week 24|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at both time points|||percent change||95% Confidence Interval|Least Squares Mean
2812002|NCT00437658|Primary|Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24|Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.|Baseline and week 24|Participants who received at least one dose (i.e., one tablet or injection) of study drug (safety analysis set) with available BMD data at both time points|||percent change||95% Confidence Interval|Least Squares Mean
2812003|NCT00437645|Secondary|Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12|Systolic response was defined as msSBP < 130 mmHg or at least a 20 mmHg reduction from baseline in msSBP at Weeks 4, 8, and 12. Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||Percentage of patients|||Number
2812004|NCT00437645|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||mmHg||Standard Error|Least Squares Mean
2812005|NCT00437645|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||mmHg||Standard Error|Least Squares Mean
2812006|NCT00437645|Primary|Percentage of Patients With Peripheral Edema From Baseline to Week 8|Only occurrences of peripheral edema quantified as a reported adverse event coded as peripheral edema were included in the analysis. If a patient experienced more than one occurrence of peripheral edema between Day 1 and Week 8, it was only counted once in the analysis.|Baseline to Week 8|Safety population: All randomized patients.|||Percentage of patients|||Number
2812007|NCT00437645|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).|||mmHg||Standard Error|Least Squares Mean
2812008|NCT00437489|Secondary|Hypoglycemia Event Rate Per Month|Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).|up to week 4 or 16|FAS Population|||event rate per month||Standard Deviation|Mean
2812009|NCT00437489|Secondary|Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia|Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.|week 16|FAS Population - Descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.|||participants|||Number
2812010|NCT00437489|Primary|Change in HbA1c From Baseline|Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16|From baseline to week 16|Full analysis set (FAS) population - descriptive statistics were produced using last observation carried forward (LOCF) for Week 16, therefore all subjects are included in the Week 16 data.|||Percent||Standard Deviation|Mean
2812011|NCT00437489|Secondary|Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)|Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.|From baseline to week 16|FAS - descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.|||mmol/l||Standard Deviation|Mean
2812012|NCT00437398|Secondary|Mean Glycated Hemoglobin (HbA1c) Since Transplant|HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.||||||
2812013|NCT00437398|Primary|Mean Number of Hypoglycemic Events After Transplant|Hypoglycemia is an abnormally diminished content of glucose in the blood.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.||||||
2812014|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Day 8 up to 28 days after open-label dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.|||adverse events|||Number
2812015|NCT00437281|Secondary|Renal Clearance (CLr): Single-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are only reported for pregabalin 15 mg/kg/day, 7 to 11 years and pregabalin 5 mg/kg/day, 12 to 16 years because none of the participant had PK parameter available in rest of the groups.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2812208|NCT00436345|Secondary|Sedation-Agitation for Day 7|"Sedation - Agitation was assessed, using the Riker Sedation-Agitation Scale (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable."|Day 7|mITT Population according to the participants’ status|||points on a scale||Standard Deviation|Mean
2812016|NCT00437281|Secondary|Renal Clearance (CLr): Multiple-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for some of the groups since none of the participant had PK parameter available in these groups.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2812017|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Single-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2812018|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Multiple-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2812019|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Single-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||hours||Standard Deviation|Mean
2812020|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2812021|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis|Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||hours||Full Range|Median
2812022|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis|Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hours||Full Range|Median
2812023|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis|Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2812024|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis|Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2812037|NCT00437203|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng/mL||Standard Deviation|Geometric Mean
2812228|NCT00436332|Secondary|Progression-free Survival||From date of registration to maximum of 3 years||||months||95% Confidence Interval|Median
2812229|NCT00436332|Primary|Overall Survival||From date of registration to maximum of 3 years||||months||95% Confidence Interval|Median
2812025|NCT00437281|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.|||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2812026|NCT00437281|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis|Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2812027|NCT00437281|Secondary|28-Day Seizure Frequency Rate|Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)*28.|Baseline up to 7 days post-last dose of study medication|Results are not reported since the data was reported in individual participant listings but not summarized for analysis.||||||
2812028|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Baseline to Day 7|Safety analysis set included all participants who received at least 1 dose of study medication.|||adverse events|||Number
2812029|NCT00437281|Secondary|Number of Participants With Clinically Significant Change in Physical and Neurological Findings|Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.|Baseline up to 7 days post-last dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2812030|NCT00437203|Secondary|Metabolite Profile of PF-00477736 in Plasma and Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||percentage of recovered metabolite|||Number
2812031|NCT00437203|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||hr||Standard Deviation|Mean
2812032|NCT00437203|Secondary|Concentration of PF-00477736 in Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng/mL||Standard Deviation|Geometric Mean
2812033|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng*hr/mL||Standard Deviation|Geometric Mean
2812034|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]|AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng*hr/mL||Standard Deviation|Geometric Mean
2812035|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0|Data was not analyzed, as study was terminated due to business reasons.|||ng*hr/mL||Standard Deviation|Geometric Mean
2812036|NCT00437203|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||hr||Full Range|Median
2812038|NCT00437203|Secondary|Maximum Observed Plasma Concentration (Cmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.|||ng/mL||Standard Deviation|Geometric Mean
2812039|NCT00437203|Secondary|Number of Participants With Objective Response (OR)|OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.|Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62|FAS included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2812040|NCT00437203|Primary|Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine||Up to Day 21 Cycle 1|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.|||mg|||Number
2812041|NCT00437125|Secondary|Number of Participants Who Reached Remission by 12 Weeks|Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score <=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||participants|||Number
2812042|NCT00437125|Secondary|Number of Participants Who Responded to Treatment by 12 Weeks|Response was defined as a >= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||participants|||Number
2812043|NCT00437125|Secondary|Laboratory Analytes|Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.|baseline through 12 weeks|All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.|||participants|||Number
2812044|NCT00437125|Secondary|Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study|Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.|baseline through 12 weeks|All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.|||participants|||Number
2812045|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Heart Rate|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.|||beats per minute||95% Confidence Interval|Mean
2812046|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Blood Pressure|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.|||millimeter mercury||95% Confidence Interval|Mean
2812047|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score|The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.|baseline, 12 weeks|All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.|||units on a scale||Standard Deviation|Mean
2812048|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.|||units on a scale||Standard Deviation|Mean
2812049|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.|||units on a scale||Standard Deviation|Mean
2812050|NCT00437125|Secondary|Patient's Global Impression-Improvement at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.|||participants|||Number
2812051|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||units on a scale||Standard Deviation|Mean
2812052|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.|||units on a scale||Standard Deviation|Mean
2812053|NCT00437125|Secondary|Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)|"Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21)."|baseline, 4 weeks, 8 weeks, 12 weeks|All treated participants with baseline and post-baseline data for >= 1 visit for >= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).|||units on a scale||Standard Deviation|Mean
2812054|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale|Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.|||units on a scale||Standard Deviation|Mean
2812055|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.|||units on a scale||Standard Deviation|Mean
2812056|NCT00437125|Primary|Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death|The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.|baseline through 12 weeks|All treated participants.|||participants|||Number
2812057|NCT00437073|Secondary|Percentage of Participants With a >=20% Volumetric Reduction in CNS Lesions|The percentage of participants with a >=20% volumetric reduction in CNS lesions was defined as the percentage of treated participants achieving at least a 20% volumetric reduction in CNS lesions relative to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|Baseline; from the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812058|NCT00437073|Secondary|Percentage of Participants With Disease Stabilization for 6 Months or More|The percentage participants with disease stabiliztion for 6 months or more were defined as those treated participants with a best CNS objective response of SD whose disease stabilization lasted 6 months or more from the start of treatment. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812059|NCT00437073|Secondary|Percentage of Participants With Baseline Tumor-related (TR) Neurological Signs and Symptoms (NSS), Who Experienced Improvement in NSS as Measured by the Neurological Examination Worksheet (NEW)|TR NSS was to be recorded by the Investigator on the NEW, using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE V3.0). Improvement was to be defined as a decrease of 1 or more CTCAE grades from baseline of any TR NSS. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812060|NCT00437073|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812061|NCT00437073|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment until the first documented sign of disease progression at any site or death due to any cause, if sooner. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812062|NCT00437073|Secondary|Number of Participants With the Indicated Site of Initial Disease Progression|The site of initial disease will be determined by taking the earliest date of known progression and assigning the appropriate category (CNS or non-CNS) based on the source of the earliest date. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812063|NCT00437073|Secondary|Time to CNS Objective Response (Defined as the Time From the Start of Treatment Until the First Documented Evidence of Partial or Complete Tumor Response [Whichever Status is Recorded First])|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812064|NCT00437073|Secondary|Percentage of Participants (Par.) With Objective Response by RECIST in Non-CNS Disease|Non-CNS disease (for par. with measurable baseline non-CNS disease) OR is defined as the number of par. with either a CR or PR as assessed by computed tomography (CT) or MRI scan and RECIST. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough par. enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812065|NCT00437073|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR (complete resolution of all evaluable and non-evaluable brain metastases), PR (=>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline), or stable disease (disease that does not meet CR, PR, or CNS progression criteria) for at least 6 months. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812066|NCT00437073|Secondary|Duration of CNS Objective Response (Defined as the Time From the First Documented Evidence of CNS PR or CR Until the First Documented Sign of Disease Progression or Death, if Sooner)|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||||||
2812067|NCT00437073|Primary|Number of Participants With the Indicated CNS Responses|"CNS responses were assessed by volumetric (V) analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases (BMs). PR: =>50% reduction in the V sum of all evaluable BMs compared to baseline. A response of Other was used for participants who discontinued the study prior to the first efficacy assessment. Stable Disease (SD): disease that does not meet CR, PR, or CNS progression criteria. Progressive disease (PD): a requirement for a new steroid or an increasing steroid dose for the treatment of worsening neurological signs/symptoms due to BMs."|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||participants|||Number
2812068|NCT00437073|Primary|Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR)|CNS OR is defined as the number of participants with either a complete response (CR) or partial response (PR) as assessed by volumetric analysis of brain magnetic resonance imaging (MRI) and Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|Modified Intent-to-Treat (mITT) Population: all participants who had at least one evaluable CNS target lesion at baseline and who had received at least two doses of lapatinib medication|||participants|||Number
2812069|NCT00437034|Secondary|Circulating Endothelial Progenitors|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year|||||||
2812108|NCT00436956|Secondary|Median Progression Free Survival (PFS)|Time interval from start of treatment to documented evidence of disease progression.|up to 14.9 months based on a Kaplan-Meier analysis.||||Months||95% Confidence Interval|Median
2812070|NCT00437034|Secondary|Proangiogenic Factors Such as VEGF|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year|||||||
2812071|NCT00437034|Secondary|The Apoptotic State of Tumor Neovasculature|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)|||||||
2812072|NCT00437034|Secondary|Tissue Expression Patterns of VEGFR Subtypes|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar's test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)|||||||
2812073|NCT00437034|Secondary|Toxicities|Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 terminology. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.|During treatment and follow up|||||||
2812074|NCT00437034|Secondary|Overall Survival (OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|Time from first treatment day until death, assesseduUp to 6 months|||||||
2812075|NCT00437034|Secondary|Progression-free Survival (PFS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|Time from first treatment day until objective or symptomatic progression, assessed up to 6 months|||||||
2812076|NCT00437034|Primary|Overall Response Rate (Complete [CR] and Partial Response [PR])|"A 95% confidence interval was intended to be estimated via binomial proportions, but was not computed due to small sample size.~Criteria for Response from EBMT, IBMTR, ABMTR: Complete Response:Complete absence of monoclonal protein by immunofixation for a minimum of 6 weeks; Near Complete Response:Absence of serum paraprotein by standard serum/urine protein electrophoresis without disappearance of monoclonal spike by immunofixation; Partial Response:Sustained decrease in production rate of monoclonal serum protein to 50% or less of pretreatment value; Stable Disease: No significant change from baseline; Progression of Disease:Patients with a > or = 25% rise in production rate, new/increased size of lytic lesions/plasmacytomas/progressive marrow plasmacytosis; Symptomatic Deterioration:Patients with deterioration of health requiring discontinuation of treatment w/out objective evidence of disease progression."|At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.||||participants|||Number
2812077|NCT00436982|Secondary|Blood Loss|Blood loss during surgery|intra-operative|The protocol indicates blood loss as a secondary measure but this value was not collected. Therefore no data can be posted.||||||
2812078|NCT00436982|Secondary|Duration Hospital Stay||preoperative to discharge||||days||Standard Deviation|Mean
2812079|NCT00436982|Secondary|Mean Operative Time|Skin to skin operative time|intra-operative||||minutes||Standard Deviation|Mean
2812080|NCT00436982|Secondary|Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire|"The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.~NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected."|pre-operative, 3 months, 1, 2, 5, 7 and 10 years|Participants with data available at each time point. Overall number of participants and units analyzed is based upon the 2 year population|||units on a scale||Standard Deviation|Mean
2812081|NCT00436982|Secondary|Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire|"KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.~[taken from User Guide] http://www.koos.nu/"|pre-operative, 3 months, 1, 2, 5, 7 and 10 years|Participants with data available at each time point.|||units on a scale||Standard Deviation|Mean
2812082|NCT00436982|Secondary|Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|[Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years]|Participants with data available at each time point.|||units on a scale||Standard Deviation|Mean
2812083|NCT00436982|Secondary|Roentgen Stereophotogrammetric Analysis (RSA)|To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.|3 months, 1, 5, 7 and 10 years|Participants with data available at each time point.|||mm||Standard Deviation|Mean
2812084|NCT00436982|Primary|Roentgen Stereophotogrammetric Analysis (RSA)|To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.|2 years||||mm||Standard Deviation|Mean
2812109|NCT00436956|Secondary|Median Overall Survival|Time from treatment start date until date of death or date last known alive.|44 months||||Months||95% Confidence Interval|Median
2812110|NCT00436956|Secondary|Number of Grade 3 Toxicities|Here is the number of Grade 3 (severe) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.|||toxicities|||Number
2812085|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812086|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
2812087|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812088|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
2812089|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812090|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
2812091|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812111|NCT00436956|Secondary|Number of Grade 2 Toxicities|Here is the number of Grade 2 (moderate) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.|||toxicities|||Number
2812092|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
2812093|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812094|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
2812095|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (As Treated)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
2812096|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812097|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
2812098|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812112|NCT00436956|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 61.5 months||||Participants|||Count of Participants
2812099|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||units on a scale||Standard Error|Least Squares Mean
2812100|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||units on a scale||Standard Error|Least Squares Mean
2812101|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||units on a scale||Standard Error|Least Squares Mean
2812102|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~The difference in pain was calculated as visit score - baseline score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
2812103|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)|The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
2812104|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.|||Percentage of Participants||95% Confidence Interval|Number
2812105|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||Percentage of Participants||95% Confidence Interval|Number
2812106|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (Per Protocol)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.|||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
2812107|NCT00436956|Secondary|Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response was evaluated by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Every 2 cycles (approximately 56 days)|One patient was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Out of 59 patients, 39 had measurable disease.|||Participants|||Count of Participants
2812113|NCT00436956|Primary|Percent Probability of Participants With 6-month Progression-free Survival (PFS)|PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of >/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started. Data is estimated and the probability of PFS as a function of time was determined using the Kaplan-Meier method.|6 months|One participant was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Since the prednisone was added to relieve toxicity & outcome data is based on response, the cohorts were analyzed together in terms of response. No suggestion prednisone significantly altered outcomes.|||percent probability|||Number
2812114|NCT00436917|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from date of randomization to the documentation of disease progression.|Up to 5 years|None of the participants had disease progression.||||||
2812115|NCT00436917|Secondary|Maximum-Grade Toxicity Incidence at Least Possibly Related to Study Medications|Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1=Mild, Grade 2=Moderate.|5 years||||Participants|||Count of Participants
2812116|NCT00436917|Secondary|Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry|Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 5 year|Analysis was performed on data where participants had the same baseline and 5 year BMD Femoral Neck measurement location (Left femoral, right femoral)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812117|NCT00436917|Secondary|Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry|Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 4 year|Analysis was performed on data where participants had the same baseline and 4 year BMD Femoral Neck measurement location (Left femoral, right femoral)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812118|NCT00436917|Secondary|Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry|Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 3 year|Analysis was performed on data where participants had the same baseline and 3 year BMD Femoral Neck measurement location (Left femoral, right femoral)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812119|NCT00436917|Secondary|Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry|Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 2 year|Analysis was performed on data where participants had the same baseline and 2 year BMD Femoral Neck measurement location (Left femoral, right femoral)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812120|NCT00436917|Secondary|Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry|Change: BMD values at year 1 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 1 year|Analysis was performed on data where participants had the same baseline and 1 year BMD Femoral Neck measurement location (Left femoral, right femoral)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812121|NCT00436917|Secondary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry|Change: BMD values at year 5 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 5 year|Analysis was performed on data where participants had the same baseline and 5 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812122|NCT00436917|Secondary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry|Change: BMD values at year 4 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 4 year|Analysis was performed on data where participants had the same baseline and 4 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812123|NCT00436917|Secondary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry|Change: BMD values at year 3 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 3 year|Analysis was performed on data where participants had the same baseline and 3 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812124|NCT00436917|Secondary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry|Change: BMD values at year 2 post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 2 year|Analysis was performed on data where participants had the same baseline and 2 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812125|NCT00436917|Primary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)|Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 1 year|The primary analysis is performed on data where participants had the same baseline and 1 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)|||Percentage of the baseline value||95% Confidence Interval|Mean
2812126|NCT00436904|Secondary|Time to Disease Progression|Calculated from date of registration to date of disease progression. In patients that have not progressed, time to disease progression will be censored at the patient's last evaluation date.|Time from registration to progression (up to 5 years)||||Months||95% Confidence Interval|Median
2812127|NCT00436904|Secondary|Survival|Survival is calculated from the date of registration to the date of death due to any cause. In patients who are still alive, survival will be censored at the last date when the patient was known to be alive.|Death or last follow-up (up to 5 years)|At analysis time, only 1 out of 30 patients had died. Thus, median survival was not attainable.|||Months||95% Confidence Interval|Median
2812128|NCT00436904|Secondary|Duration of Response|Duration of response is calculated from the date of documented response until the date of progression in the subset of patients who respond to treatment. In patients who have not yet progressed, duration of response will be censored at the patient's last evaluation date.|Up to 5 years|Patients that responded were included in the analysis.|||Months||95% Confidence Interval|Median
2812129|NCT00436904|Secondary|Time to Response|Calculated from the date of registration until the first date at which the patient's objective status was classified as a response. In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. Response is defined the same way as in the response primary outcome measure.|Registration to first response (up to 5 years)||||Days||95% Confidence Interval|Median
2812130|NCT00436904|Primary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. >~> Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration||||participants|||Number
2812131|NCT00436904|Primary|Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months|Confirmed response is defined as a > 50% decrease in clinical symptoms from baseline and recovery from blood counts.|Up to 6 months|Number of patients with a confirmed response out of total patients evaluable for response.|||participants||95% Confidence Interval|Number
2812132|NCT00436852|Secondary|Pharmacokinetics of ABT-751: AUC|Values of the area under concentration time curve [AUC(0-∞)] will be determined for the first dose. Descriptive statistics for these variables will be provided.|After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.|All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined.|||mg·hours/ml||Full Range|Median
2812133|NCT00436852|Secondary|Pharmacokinetics of ABT-751: Tmax|Values of the time to maximum observed concentration (Tmax) will be determined for the first dose.Descriptive statistics for these variables will be provided.|After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.|All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined.|||hours||Full Range|Median
2812134|NCT00436852|Secondary|Pharmacokinetics of ABT-751: Cmax|Values of the maximum observed concentration (Cmax) will be determined for the first dose.Descriptive statistics for these variables will be provided.|After the first dose of ABT-751, at 0.5, 1, 2, 3, 5, 8, 10-12, and 24 hours post-dose.|All eligible patients from Group 1 (Disease Evaluable by I-MIBG Scintigraphy (ABT-751)) and Group 2 (Measurable Disease by CT or MRI Scan (ABT-751)) who received the first dose of ABT-751 and participated in the pharmacokinetic studies were included in the analysis and are presented as a single Group, as the interest was in both groups combined.|||mg/ml||Full Range|Median
2812135|NCT00436852|Secondary|Percentage of Participants With Grade 3 or Higher Toxicity|Percentage of patients with at least one Grade 3 or higher toxicity, as assessed by Common Terminology Criteria for Adverse Events version 3.0, will be tabulated.|From enrollment until 30 days after the end of protocol therapy|All eligible patients who received at least 1 dose of ABT-751 were evaluable for toxicity and included in the analysis.|||Percentage of patients|||Number
2812136|NCT00436852|Secondary|Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0|The QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), with higher scores indicating better health-related quality of life, and the average of all 23 items will be calculated as the composite score.|At baseline|Eligible patients with a QOL evaluation at baseline were included in the analysis.|||Scores on a scale||Full Range|Median
2812137|NCT00436852|Secondary|Objective Response Rate|The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the percentage. Responders were defined as patients who achieved a best overall response of complete response (CR) or partial response (PR) at any time on the study including patients who achieved ≥PR and later had progressive disease or relapse. Response in patients with measurable disease will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or by Curie criteria for measuring response by MIBG scans in patients with evaluable disease by 123I-MIBG scan. Per RECIST: CR= Disappearance of all target lesions; PR= at least 30% decrease in the sum of the longest diameter of target lesions. Per Curie criteria: CR= complete resolution of all MIBG positive lesions; PR= resolution of at least one MIBG positive lesion with persistence of other MIBG positive lesions.|Duration of protocol therapy, up to 3 years|Patients who met study eligibility criteria and received at least one dose of oral ABT-751 were evaluable for the response analysis.|||Percentage of patients||95% Confidence Interval|Number
2812138|NCT00436852|Primary|1-year Progression-free Survival|PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.|From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).|||percent probability||95% Confidence Interval|Number
2812194|NCT00436475|Primary|Chang in Disposition Index, a Measure of Beta Cell Function|Range is 0 to infinity Lower is better.|baseline and 4 months||||units on a scale||Standard Error|Mean
2812139|NCT00436852|Primary|Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors|Median time to progression observed on ABT-751, along with 95% confidence intervals.|From time to enrollment to death due to any cause, assessed up to 5.1 years|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).|||days||95% Confidence Interval|Median
2812140|NCT00436826|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement. The annualized relapse rate for each treatment group was the mean of the annualized relapse rates for all the participants in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.|||relapses per year||95% Confidence Interval|Number
2812141|NCT00436826|Secondary|Number of Combined Unique Active (CUA) Lesions, Active Time Constant 2 (T2) Lesions, and Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, active T2 lesions, and T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans|Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.|||Lesions||Standard Deviation|Mean
2812142|NCT00436826|Secondary|Number of Qualifying Relapses|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.|||Relapses||Standard Deviation|Mean
2812143|NCT00436826|Primary|Percentage of Participants With Adverse Events in Infections and Infestations System Organ Class (SOC)|Adverse Events were entered in infections and infestations SOC as per medical dictionary for regulatory activities (MedDRA) version 11.0|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.|||Percentage of participants|||Number
2812144|NCT00436826|Primary|Percentage of Participants With Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE]) Hematological or Liver Toxicity|Percentage of participants with Grade 3 or 4 CTCAE toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT) and Aspartate transaminase (AST). According to CTCAE: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.|||Percentage of participants|||Number
2812145|NCT00436826|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.|||Participants|||Number
2812146|NCT00436748|Secondary|Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age|Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).|Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose|Due to the low number of participants <6 years of age summary concentration analyses were not performed.||||||
2812147|NCT00436748|Secondary|Number of Participants Who Developed Anti-erythropoiesis Antibodies|Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen's Surface Plasmon Resonance Immunoassay (SPRIA) method.|25 weeks|Safety analysis set with both pre and postdose immunoassay antibody results|||participants|||Number
2812148|NCT00436748|Secondary|Change From Baseline in Diastolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."|||mmHg||Standard Deviation|Mean
2812149|NCT00436748|Secondary|Change From Baseline in Systolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."|||mmHg||Standard Deviation|Mean
2812150|NCT00436748|Secondary|Maximum Increase in Hemoglobin Over Any 2 Week Period|The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.|25 weeks|Safety analysis set|||g/dL/2 weeks||Standard Deviation|Mean
2812151|NCT00436748|Secondary|Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study||25 weeks|Safety analysis set|||participants|||Number
2812152|NCT00436748|Secondary|Hemoglobin Serial Rate of Change (ROC) Over Time|Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."|||g/dL/week||Full Range|Median
2812195|NCT00436436|Secondary|Overall Survival|Defined as the interval between the day of first administration of treatment and the date of death.|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
2812230|NCT00436215|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 28 months||||Participants|||Count of Participants
2812153|NCT00436748|Secondary|Number of Participants With Treatment-emergent Adverse Events|A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies.|25 weeks|Safety analysis set including all participants who received ≥ 1 dose of investigational product.|||participants|||Number
2812154|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL child self-reported questionnaire was used in children > 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set aged > 5 years and with available data for each score at each time point (indicated by n)."|||units on a scale||Standard Error|Mean
2812155|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents' perceptions of their child's HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set with available data for each score at each time point (indicated by n)."|||units on a scale||Standard Error|Mean
2812156|NCT00436748|Secondary|Darbepoetin Alfa Weight-Adjusted Dose Over Time|Arithmetic means are provided; Withheld doses are counted as 0 μg.|Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n). Numbers > 0 on non-darbepoetin alfa dosing weeks for the Q2W group reflect participants who did not receive the assigned placebo dose (eg, dose withheld per investigator decision based on hemoglobin value or missed visit)."|||μg/kg||Standard Deviation|Mean
2812157|NCT00436748|Secondary|Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL|The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL) for whom dosing data were available.|||μg/kg||Standard Deviation|Mean
2812158|NCT00436748|Secondary|Hemoglobin Concentration Over Time||Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n)."|||g/dL||Standard Deviation|Mean
2812159|NCT00436748|Secondary|Time to First Hemoglobin Value ≥ 10.0 g/dL|The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL)|||days||Inter-Quartile Range|Median
2812160|NCT00436748|Primary|Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL|The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.|24 weeks|Efficacy analysis set|||proportion of participants||95% Confidence Interval|Number
2812161|NCT00436644|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from Registration to Death or last follow-up (up to 3 years)||||months||95% Confidence Interval|Median
2812162|NCT00436644|Secondary|Adverse Event Profile|Number of patients that experienced adverse events (grade 3 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 4 weeks||||participants|||Number
2812163|NCT00436644|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression, with patients who are progression free being censored on the date of their last evaluation.|Time from registration to progression (up to 2 years)||||months||95% Confidence Interval|Median
2812207|NCT00436345|Secondary|Sedation-Agitation From Day 8 to Day 10|"Sedation - Agitation was assessed, using the Riker Sedation-Agitation Scale (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable."|Days 8, 9, and 10|mITT Population according to the participants’ status|||points on a scale||Standard Deviation|Mean
2812164|NCT00436644|Primary|Response Rate (Complete Response (CR) or Partial Response (PR))|"Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter >= 2cm with conventional techniques or >=1cm with spiral CT~Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.~Non-measurable disease patients:~Decrement in CA125 by > 50%~Improvement in other evaluable disease"|Two consecutive evaluations at least 4 weeks apart||||participants|||Number
2812165|NCT00436618|Secondary|Time to Progression|The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||years||95% Confidence Interval|Median
2812166|NCT00436618|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier.~Progression is defined as the following:~CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): >=50% increase in nodes from nadir or >=50% increase in liver/spleen size from nadir.~Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% lymph node increase in SPD of > 1 node or new nodes, or >50% liver/spleen size increase, or > 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology.~All Others: New lesions or >=50% lymph nodes."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||years||95% Confidence Interval|Median
2812167|NCT00436618|Secondary|Overall Survival|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||years||95% Confidence Interval|Median
2812168|NCT00436618|Primary|Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.|"CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.~Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions.~All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.|||percentage of patients in group||95% Confidence Interval|Number
2812169|NCT00436605|Primary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used|Time from start treatment to time of progression, assessed up to 6 months||||weeks||Full Range|Mean
2812170|NCT00436605|Primary|Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria|Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.|After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment||||participants|||Number
2812171|NCT00436566|Secondary|Incidence of Pulmonary Events|Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.|5 years|||||||
2812172|NCT00436566|Secondary|Quality-of-life||5 years|||||||
2812173|NCT00436566|Secondary|Comparison of Selected Quality-of-life Questionnaires||5 years|||||||
2812174|NCT00436566|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years|||||||
2812175|NCT00436566|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years|||||||
2812176|NCT00436566|Secondary|Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) Between Two Time Points||5 years|||||||
2812177|NCT00436566|Secondary|Cumulative Incidence (CI) of Cardiac Events|"Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.~Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)"|5 years|||||||
2812178|NCT00436566|Secondary|Adverse Event Profile as Measured by NCI CTCAE v 3.0|Maximum grade for each type of adverse event will be recorded for each patient.|5 years|||||||
2812179|NCT00436566|Primary|Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment||6 months||||participants|||Number
2812231|NCT00436215|Secondary|Progression-free Survival|Progression free survival is defined by the number of weeks between the first day of treatment and the date of cancer progression.|up to 28 months||||Weeks||Standard Deviation|Mean
2812180|NCT00436553|Primary|Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 up to Month 11|Full analysis set (FAS) - Only the combination groups were analyzed. The percent of subjects with a ranibizumab treatment-free interval of at least 3 months duration following the Month 2 ranibizumab treatment was calculated using the subjects still in the study at Month 5.|||Percent of participants|||Number
2812181|NCT00436553|Secondary|Change From Baseline in Central Retinal Thickness at Month 12|Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.|Baseline and Month 12|Full analysis set (FAS), observed data.|||micrometer||Standard Deviation|Mean
2812182|NCT00436553|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|Full analysis set (FAS), observed data.|||Percentage of participants|||Number
2812183|NCT00436553|Secondary|Change From Baseline in Total Area of Leakage of the Study Eye at Month 12|Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Baseline and Month 12|Full analysis set (FAS), observed data.|||mm^2||Standard Deviation|Mean
2812184|NCT00436553|Primary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) was utilized.|||Letters||Standard Deviation|Mean
2812185|NCT00436501|Secondary|Number of Participants With PFS (Phase II)|Progression-free survival (PFS) defined as number of participants out of total in arm that had no disease progression as measured at 6 months. Standard RECIST criteria used to evaluate response and progression. All documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after initial documentation of response. In the absence of new symptoms, response assessment was consistently done after two additional cycles of therapy.|6 months|"Phase I, 2 participants had partial response and 3 were stable disease for a total of 5 responses but only 2 had a Clinical Response (confirmed).~Phase II, 46 participants was evaluable out of 49 enrolled for response/toxicity."|||Participants|||Count of Participants
2812186|NCT00436501|Secondary|Number of Participants With Treatment-related Adverse Effects as Assessed by NCI CTCAE v3.0 (Phase II)|Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v3.0 (Phase II)|Up to 6 years||||Participants|||Count of Participants
2812187|NCT00436501|Secondary|Overall Median Duration of Response (Phase II)|Duration of the response from time response is achieved until disease progression is detected. Response assessed following treatment (every 3 weeks) for disease progression. Study duration January 2007 to May 2013, approximately six and half years.|Response assessed following treatment (every 3 weeks), up to 6 years. Study duration January 2007 to May 2013.|Number analyzed represents those Phase II participants with response as documented in Outcome Measure 2.|||months||Full Range|Median
2812188|NCT00436501|Primary|Median Progression-Free Survival (PFS) (Phase II)|Progression-Free Survival was calculated from study entry until documented disease, death or date of last contact.|Time from start of treatment to time of progression, assessed up to 6 years.||||months||95% Confidence Interval|Median
2812189|NCT00436501|Primary|Overall Objective Response Rate According to RECIST (Phase II)|The percentage of participants in the Phase II arm with an objective response defined as a measurable response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Standard RECIST criteria were followed to evaluate response and progression. All documented responses were required to undergo confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, this response assessment was consistently done after two additional cycles of therapy.|Up to 6 months||||percentage of participants|||Number
2812190|NCT00436501|Primary|Median Overall Survival (OS) (Phase II)|Overall survival was defined from the date of study entry until death or date of last contact. Median survival time points calculated in the method of Kaplan-Meier. Standard RECIST criteria followed to evaluate response and progression, and all documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, response assessment consistently done after two additional cycles of therapy.|Time from start of treatment to time of progression, assessed up to 6 years.||||months||Full Range|Median
2812191|NCT00436501|Primary|Number of Participants With Clinical Response (Partial Response or Complete Response) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Frequency of clinical response (partial response or complete response) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >/= 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >/= 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1+ new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 6 months||||participants|||Number
2812192|NCT00436501|Primary|Maximum Tolerated Dose of VEGF Trap (Phase I)|Escalating dose levels of VEGF Trap were administered intravenously over three dose levels (2, 4, or 6 mg/kg; one dose every 21 days) to identify the maximum tolerated dose (MTD). The MTD is defined as the highest dose level below which 2 or more patients encounter a dose limiting toxicity (DLT), graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. MTD established on absence of observed DLT(s) in either cycle 0 (single agent) or cycle 1 (combination therapy) of any given dose level.|21 day cycle, up to 3 cycles||||mg/kg|||Number
2812193|NCT00436475|Secondary|Change in Hemoglobin A1c|This outcome measures change in Hemoglobin A1c, a measure of glycemia|Baseline to 4 months||||% of hemoglobin||Standard Error|Mean
2812196|NCT00436436|Secondary|Progression-free Survival|Defined as the interval between the day of first administration of treatment and the first documentation of progressive disease or date of death. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
2812197|NCT00436436|Secondary|Best Overall Response|Defined as the best tumor response recorded from the start of treatment until disease progression or withdrawal from the study. Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer|up to 2 years|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
2812198|NCT00436436|Secondary|Toxicity as Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v 3)|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. Adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE)v3.|18 months and 4 days||||Participants|||Count of Participants
2812199|NCT00436436|Secondary|Objective Tumor Response Rate in Patients With Methylguanine Methyltransferase (MGMT)-Negative Tumors as Assessed by Immunohistochemistry (IHC)|The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|2-4 weeks|Twelve patients were enrolled. The principal investigator wished to analyze the data but felt that there was insufficient data to report on and therefore closed the protocol when he left the National Cancer Institute (NCI).||||||
2812200|NCT00436436|Primary|Confirmed Best Objective Tumor Response Rate (Complete or Partial Response) in Patients With Methylguanine Methyltransferase (MGMT)-Positive Tumors as Assessed by Immunohistochemistry (IHC)|The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions.|2-4 weeks|No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.||||||
2812201|NCT00436345|Secondary|Pain Intensity From Day 8 to Day 10|"Pain Intensity was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain."|Days 8, 9, and 10|mITT Population. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.|||points on a scale||Standard Deviation|Mean
2812202|NCT00436345|Secondary|Pain Intensity (PI)|"Pain Intensity was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain."|Up to 38 days|ITT Population, according to the participants' status. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.|||Points on a scale||Standard Deviation|Mean
2812203|NCT00436345|Secondary|Bispectral Index (BIS) for Extubation Period and Post-Extubation Period|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|up to 38 days|mITT Population. The BIS value was recorded only for 2 participants, in the extubation and post-extubation periods.|||points on a scale||Standard Deviation|Mean
2812204|NCT00436345|Secondary|Bispectral Index (BIS) for Day 5|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Day 5|mITT Population. At Day 5, only one participant remained in the study; the others were already extubated.|||points on a scale||Standard Deviation|Mean
2812205|NCT00436345|Secondary|Bispectral Index (BIS)|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Screening through End of Study, up to 38 days|mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study.|||Points on a scale||Standard Deviation|Mean
2812206|NCT00436345|Secondary|Number of Participants Analyzed for BIS (Bispectral Index Scale)|Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Up to 38 days|mITT Population|||participants|||Number
2812209|NCT00436345|Secondary|Sedation-Agitation From Screening Through the End of Study|"Sedation - Agitation was assessed, using the Riker Sedation-Agitation Scale (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable."|Up to 38 days|mITT Population, according to the participants’ status|||Points on a scale||Standard Deviation|Mean
2812210|NCT00436345|Secondary|Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale|"Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. Sedation - Agitation was assessed, using the Riker Sedation-Agitation Scale (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. Pain Intensity was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain."|Up to 38 Days|mITT Population|||participants|||Number
2812211|NCT00436345|Secondary|Total Dose of Fentanil Administered - Bolus|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Fentanil were analyzed.|||ug/kg||Standard Deviation|Mean
2812212|NCT00436345|Secondary|Total Dose of Propofol Administered - Bolus|Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.|||mg/kg||Standard Deviation|Mean
2812213|NCT00436345|Secondary|Dose of Morphine Administered - Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Morphine were analyzed.|||mg/kg/h||Standard Deviation|Mean
2812214|NCT00436345|Secondary|Dose of Propofol Administered - Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.|||mg/kg/h (milligrams per kilogram per hr)||Standard Deviation|Mean
2812215|NCT00436345|Secondary|Doses of Sufentanil and Fentanil Administered - Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.|||ug/kg/h||Standard Deviation|Mean
2812216|NCT00436345|Secondary|Dose of Remifentanil Administered - Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.|||ug/kg/h (micrograms per kilogram per hr)||Standard Deviation|Mean
2812217|NCT00436345|Secondary|Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Sufentanil, Fentanil, and Morphine were analyzed.|||hours||Standard Deviation|Mean
2812218|NCT00436345|Secondary|Duration of Propofol Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Propofol were analyzed.|||hours||Standard Deviation|Mean
2812219|NCT00436345|Secondary|Duration of Remifentanil Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days (240 hours)|ITT Population. Only participants infused with Remifentanil were analyzed.|||Hours||Standard Deviation|Mean
2812220|NCT00436345|Secondary|Duration of Weaning|Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.|up to 38 days (912 hours)|ITT Population. Only participants for which data are available were analyzed.|||hours||Standard Deviation|Mean
2812221|NCT00436345|Secondary|Duration of Extubation|Duration of extubation was measured.|up to 38 days (912 hours)|ITT Population. Only participants with available extubation data were analyzed.|||hours||Standard Deviation|Mean
2812222|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Per-Protocol Population)|Time from start of mechanical ventilation until actual extubation|Up to 38 days (912 hours)|Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation|||Hours||Standard Error|Mean
2812223|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation.|Up to 38 days (912 hours)|Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements|||Hours||Standard Error|Mean
2812224|NCT00436345|Secondary|Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision)|Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.|Up to 38 days (912 hours)|ITT Population. Only participants with available ICU data were analyzed.|||Hours||Standard Deviation|Mean
2812225|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).|Up to 38 days (912 hours)|Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication|||Hours (hr)||Standard Error|Mean
2812226|NCT00436332|Secondary|Frequency and Severity of Toxicities||From date of registration to maximum of 3 years|Number of Subjects With Greater Than Grade 2 Toxicity|||participants|||Number
2812227|NCT00436332|Secondary|Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease|Images for response assessed by the central computer-assisted image-analysis system were never collected.|From date of registration to maximum of 3 years||||Participants|||Count of Participants
2812232|NCT00436215|Primary|Clinical Response Rate.|Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.|patients were followed for a median of 18 weeks (range 1-116 weeks)|Seven patients were not evaluable for response assessment.|||percentage of participants|||Number
2812233|NCT00436163|Secondary|Percentage of Anti-HBe Positive Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.|||percentage of participants|||Number
2812234|NCT00436163|Secondary|Percentage of HBeAg Negative Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.|||percentage of participants|||Number
2812235|NCT00436163|Secondary|Mean Alanine Aminotransferase (ALT) Concentrations||Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||international units per liter (IU/L)||Standard Deviation|Mean
2812236|NCT00436163|Secondary|Percentage of Anti-HBs Positive Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.|||percentage of participants|||Number
2812237|NCT00436163|Secondary|Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||percentage of participants|||Number
2812238|NCT00436163|Secondary|Number of Participants With HBV-DNA < 400 Copies/mL||Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2812239|NCT00436163|Primary|Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.|||participants|||Number
2812240|NCT00436163|Primary|Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.|||participants|||Number
2812241|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization||||Participants|||Number
2812242|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization||||Participants|||Number
2812243|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 28 after immunization, relative to pre-immunization levels.|28 days after immunization.||||Participants|||Number
2812244|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization||||Participants|||Number
2812267|NCT00435994|Primary|Endothelial Growth Factor (VEGF)|Analysis for VEGF level by ELISA|During nasal wash|Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.|||pg/dl||Standard Deviation|Mean
2812483|NCT00434356|Secondary|Adverse Events Leading to Death|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients|||participants|||Number
2812245|NCT00436046|Secondary|Unsolicited Adverse Events After Intranasal Immunization|Number of subjects (frequency) with spontaneous reports of Adverse Events of any severity and severe or higher severity, during the 28 days after vaccination regardless of relatedness. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination.|A reporting threshold of 5.6% was selected after reviewing adverse event rates in healthy adult volunteers in similar studies sponsored by NIAID. We determined 5.6% to be the upper bound of the confidence interval to exclude reporting events that occur in 75% of healthy adults.|||Participants|||Number
2812246|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization.||||Participants|||Number
2812247|NCT00436046|Secondary|Local and/or Systemic Solicited Symptoms After Intranasal Immunization.|Number of participants (frequency) reporting solicited (systematically collected on a Memory Aid) reactogenicity events of any severity and number reporting severe occurrences.|0-7 days following immunization||||Participants|||Number
2812248|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels|14 days after immunization.||||Participants|||Number
2812249|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2812250|NCT00436007|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 30-day (Days 0-29) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2812251|NCT00436007|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 7-day (Days 0-6) follow-up period after any vaccination|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.|||subjects|||Number
2812252|NCT00436007|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.|During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.|||subjects|||Number
2812253|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2812254|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2812255|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2812308|NCT00435487|Secondary|Number of Subjects With Stroke|Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).|End of hospitalization, Day 30|Evaluable population|||participants|||Number
2812580|NCT00434057|Secondary|Biopsy Ratio|Number of lesions bioopsied to melanomas detected|Within 120 days of Data Lock||2009-12-31|12/2009||||
2812256|NCT00436007|Secondary|Titers for Anti-yellow Fever Antibodies.|"Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.~The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups."|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||titers||95% Confidence Interval|Geometric Mean
2812257|NCT00436007|Secondary|Concentrations of Anti-measles Antibodies.|Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2812258|NCT00436007|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.|Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2812259|NCT00436007|Secondary|Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).|Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||titers||95% Confidence Interval|Geometric Mean
2812260|NCT00436007|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.|Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2812261|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 8 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2812262|NCT00436007|Secondary|Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2812263|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2812264|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2812265|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2812266|NCT00436007|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2812268|NCT00435994|Primary|Lung Function|Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.|Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)|All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained.|||Z score||Standard Deviation|Mean
2812269|NCT00435942|Primary|Primary Safety Endpoint: Distribution of Major Adverse Events|The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure|1 year|The number of subjects who underwent the endovascular procedure or open surgical repair|||participants|||Number
2812270|NCT00435942|Primary|Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects|"The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.~The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met."|1 year|All subjects who underwent the Relay implant procedure (Intention to Treat)|||participants|||Number
2812271|NCT00435929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.|||participants|||Number
2812272|NCT00435929|Secondary|Number Participants With Abnormal Vital Signs|Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.|||participants|||Number
2812273|NCT00435929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters|Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.|||participants|||Number
2812274|NCT00435929|Secondary|Cluster of Differentiation 4 (CD4 ) Count|The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.|Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)|PD analysis population: All participants who received at least 1 dose of the study medication and had at least 1 pharmacodynamic (PD) measure were included in the PD analysis population.|||cells/cubic millimeter||Standard Deviation|Mean
2812275|NCT00435929|Secondary|Volume of Distribution (Vd) of SQV and RTV|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||Litres||Standard Deviation|Mean
2812276|NCT00435929|Secondary|Plasma Clearance After Oral Administration (CL/F) of SQV and RTV|The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||L/hr||Standard Deviation|Mean
2812277|NCT00435929|Secondary|Minimum Observed Plasma Concentration (Cmin) of SQV and RTV|Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||ng/mL||Standard Deviation|Mean
2812414|NCT00434759|Primary|Change From Baseline in Social Phobia Scale (SPS)|The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
2812278|NCT00435929|Secondary|Terminal Half-life (T1/2) of SQV and RTV|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||hour||Standard Deviation|Mean
2812279|NCT00435929|Secondary|Time of Maximum Plasma Concentration (Tmax) of SQV and RTV|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||hour||Standard Deviation|Mean
2812280|NCT00435929|Primary|Maximum Observed Plasma Concentration (Cmax) of SQV and RTV|The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||ng/mL||Standard Deviation|Mean
2812281|NCT00435929|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.|||ng*hr/mL||Standard Deviation|Mean
2812282|NCT00435825|Secondary|Quantitative HBV-DNA 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.|||IU/mL Log10||95% Confidence Interval|Mean
2812283|NCT00435825|Secondary|Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.|||U/L||95% Confidence Interval|Mean
2812284|NCT00435825|Secondary|Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment|Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812285|NCT00435825|Secondary|Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment|Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812286|NCT00435825|Secondary|Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812397|NCT00434954|Secondary|Patient Reported Outcomes: Quality of Life (SF-12)|SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||scores on SF-12 scale||Standard Deviation|Mean
2812287|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812288|NCT00435825|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT)|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812289|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment|Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812290|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812291|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment|Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812292|NCT00435825|Secondary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.|Week 72|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812293|NCT00435825|Primary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2812294|NCT00435812|Secondary|Percentage of Participants With Local and Systemic Reactions to Injections||Within 7 days post-injection for Post Injection Reactions|Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline data.|||Percentage of subjects|||Number
2812295|NCT00435812|Primary|Percentage of Subjects With Seroprotective Immune Response|Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)|Week 12 for HEPLISAV and Week 28 for Engerix-B|Per Protocol Population: Subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges, and had serology at their primary endpoint (Week 12 for HEPLISAV group and Week 28 for Engerix-B group)|||Percentage of Participants|||Number
2812296|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||Participants|||Number
2812297|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||Participants|||Number
2812298|NCT00435591|Secondary|Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period|"The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the placebo loading dose + YM087 premix continuous infusion arm will be reported.~Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|48.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||Hours||Inter-Quartile Range|Median
2812299|NCT00435591|Secondary|Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours|"AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|24.5 hours, 48.5 hours and 96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."|||hr * mEq/L||Standard Deviation|Mean
2812300|NCT00435591|Secondary|Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period|"Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.~Change from Baseline is calculated as Time point minus Baseline."|Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants analyzed per arm represents Full Analysis Set. The numbers of participants for each time point are noted in the category titles."|||mmol/L||Standard Deviation|Mean
2812301|NCT00435591|Primary|Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2|"Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion.~One ISRMS has been reported for each participant & represents the most severe state of ISR for that participant.~ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis"|48 hours|"Population is Safety Analysis Set (SAF): All randomized patients who received at least 1 dose of study drug.~The number of participants per arm is consistent for all categories of the data table."|||Participants|||Number
2812302|NCT00435539|Primary|Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.||Day 14|Intention to Treat (ITT)|||percentage of participants|||Number
2812303|NCT00435539|Secondary|Resolution of Vitreomacular Traction (Investigator's Assessment)|Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.|Day 28|Intention to Treat (ITT)|||Percentage of participants|||Number
2812304|NCT00435487|Secondary|Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria|Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
2812305|NCT00435487|Secondary|Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization|Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
2812306|NCT00435487|Secondary|Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
2812307|NCT00435487|Secondary|Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization|Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.|End of hospitalization, Day 30|Evaluable population|||participants|||Number
2822088|NCT00369278|Primary|Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment|Median time to first occurrence of treatment failure was not reached in this study.|6 months|||||||
2812309|NCT00435487|Primary|Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test.|Baseline to Day 30|Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint.|||participants|||Number
2812310|NCT00435461|Secondary|Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)|The NRQLQ is a paper instrument administered on the day of randomization and at Visit 4/Early Withdrawal to assess nocturnal rhinitis-related quality of life. The NRQLQ is a 16-item, self-administered, disease-specific (allergic rhinitis), and quality of life instrument that measures the functional problems most troublesome to patients with nocturnal allergy symptoms over a one-week interval. Each question is scored from 0 to 6 with higher scores indicating more nocturnal impairment. Items are grouped into four domains: Sleep problems, Sleep time problems, Symptoms on waking in the morning and Practical problems. An overall score was calculated from the mean score of all items. Each participant's average change from Baseline NRQLQ score was the participant's average NRQLQ score over the treatment period minus the participant's baseline score.|Baseline (Day 1) and Day 15|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812311|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF)|PNIF was measured by participants using an In-Check Nasal portable hand-held inspiratory flow meter and face mask. Participants recorded PNIF twice daily (in the morning prior to taking their study medication and in the evening). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Each participant's average change from Baseline PNIF was the participant's average PNIF over the treatment period minus the participant's baseline PNIF.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Liter(L)/minute (min)||Standard Error|Mean
2812312|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)|Participants were instructed to score and document their symptoms in an instantaneous manner on a diary card. The instantaneous rating was performed once daily just prior to administering their morning dose. The scores of each of the instantaneous nasal symptoms (nasal congestion, itching, rhinorrhea, and sneezing) and ocular symptoms (tearing/watering, itching/burning, and redness) were summed for each participant to create a iTNSS and iTOSS, respectively using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Total score ranged from 0 (best) to 12 (worst) for iTNSS and 0 (best) to 9 (worst) for iTOSS. Each participant's average change from Baseline iTNSS and iTOSS was participant's average iTNSS and iTOSS total score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Mean
2812313|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)|Daily 24-hour rTOSS was calculated as the average of the corresponding N-rTOSS and D-rTOSS using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 9 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself was to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participant's average 24-hour total symptom score over the treatment period minus the participant's Baseline score. Baseline is the 4 highest scores calculated for the 7 days prior to Day 1.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812314|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)|The Daytime reflective assessments were recorded each evening and assessed the 3 nasal symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the three Daytime symptoms were summed for each participant to create a D-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812321|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.|||Score on a scale||Standard Deviation|Mean
2812581|NCT00434057|Primary|Sensitivity and Specificity|Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.|Within 120 days of Data Lock|All participants with eligible and evaluable lesions were used in analysis of primary outcome measures|||Ratio * 100||95% Confidence Interval|Mean
2812315|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)|The nighttime reflective assessments were recorded each morning and assessed 3 ocular symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of 3 Nighttime symptoms were summed for each participant to create a N-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total score was average of nighttime total symptom score on day of randomization and the 3 highest scores calculated for 6 days immediately prior to the day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812316|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score|Daily 24-hour rTNSS was calculated as the average of the corresponding N-rTNSS and D-rTNSS using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 12 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself were to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participants average 24-hour total symptom score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812317|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS|The Daytime reflective assessments were recorded each evening and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the four Daytime symptoms were summed for each participant to create a D-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participants Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812318|NCT00435461|Secondary|Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score|The nighttime reflective assessments were recorded each morning and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of the 4 symptoms were summed for each participant to create a N-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total score was average of nighttime total symptom score on day of randomization and 3 highest scores calculated for 6 days immediately prior to day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's Baseline score.|Baseline (Day 1) and up to 2 Weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812319|NCT00435461|Primary|Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS)|The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS. The total score ranged from 0 (best) to 9 (worst). The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NANS) (0- Not at all, 1- Once, 2- More than once, 3- I felt like I was awake all night). Each participant's Baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization. Each participant's average change from Baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's Baseline NSS.|Baseline (Day 1) and up to 2 Weeks|Intent-to-treat (ITT) population included all participants randomized to double-blind treatment. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Mean
2812320|NCT00435409|Secondary|Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.|||Score on a scale||95% Confidence Interval|Mean
2812340|NCT00435188|Primary|Rapid Gait Speed||3-month||||meters/second||Standard Deviation|Mean
2812341|NCT00435188|Primary|Rapid Gait Speed||Baseline||||meters/second||Standard Deviation|Mean
2812342|NCT00435188|Primary|Usual Gait Speed||12-month||||meters/second||Standard Deviation|Mean
2812343|NCT00435188|Primary|Usual Gait Speed||3 month||||meters/second||Standard Deviation|Mean
2812322|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms|Day 1 of each treatment cycle (up to 3 years or end of treatment)|Patient Reported Outcomes (PRO) assessments were not analyzed because the study did not meet its primary endpoint.|||score on a scale||Standard Deviation|Mean
2812323|NCT00435409|Secondary|Percent Chance of Participant Survival|Probability of survival 2 years and 3 years after the first dose of study treatment.|Year 1, Year 2, Year 3|ITT population|||probability of survival||95% Confidence Interval|Number
2812324|NCT00435409|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.|Baseline until death or up to 3 years from first dose|ITT population|||months||95% Confidence Interval|Median
2812325|NCT00435409|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.|Baseline until response or disease progression (up to 3 years from first dose)|ITT subgroup of participants with a confirmed objective tumor response.|||months||95% Confidence Interval|Median
2812326|NCT00435409|Secondary|Percentage of Participants With Objective Response (OR)|Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population|||percentage of participants||95% Confidence Interval|Number
2812327|NCT00435409|Primary|Progression Free Survival (PFS)|Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.|Baseline until disease progression (up to 3 years from first dose)|Intent to treat (ITT) population: defined as all participants who were randomized|||months||95% Confidence Interval|Median
2812328|NCT00435370|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains|"The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study:~Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test—Identical Pairs (CPT-IP)* Wechsler Memory Scale®—3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test—Revised™ (HVLT-R™) Brief Visuospatial Memory Test—Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes~Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):"|end of 12 wk treatment||||units on a scale||Standard Deviation|Mean
2812329|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|12 month||||meters||Standard Deviation|Mean
2812330|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|3 month||||meters||Standard Deviation|Mean
2812331|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|Baseline||||meters||Standard Deviation|Mean
2812332|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|12 month||||units on a scale||Standard Deviation|Mean
2812333|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|3 month||||units on a scale||Standard Deviation|Mean
2812334|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|Baseline||||units on a scale||Standard Deviation|Mean
2812335|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|12 month||||participants|||Number
2812336|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|3 month||||participants|||Number
2812337|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|Baseline||||participants|||Number
2812338|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|12 month||||times per week||Standard Deviation|Mean
2812339|NCT00435188|Primary|Rapid Gait Speed||12-month||||meters/second||Standard Deviation|Mean
2812351|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 16|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812352|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 12|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812353|NCT00435045|Secondary|Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812354|NCT00435045|Secondary|Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812355|NCT00435045|Secondary|Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Intermediate Density Lipoprotein, or IDLs, transport cholesterol and triglycerides through the body. IDLs are a type of cholesterol that are a product of VLDL degradation and result in LDL cholesterol when broken down.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812356|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812357|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis. Chylomicrons are One of the microscopic particles of emulsified fat found in the blood and lymph and formed during the digestion of fats.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812358|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812359|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|High Density Lipoprotein partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812360|NCT00435045|Secondary|Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Lipoprotein Phosphoslipase A2 - modified form of LDL.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812593|NCT00433966|Secondary|Pharmacology Arm - Major Adverse Cardiovascular Events|Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)|30 days||||Participants|||Count of Participants
2812361|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. Researchers have linked LDL particle size to the subsequent development of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812362|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812363|NCT00435045|Secondary|Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Eicosapentaenoic acid (EPA) is one of several omega-3 fatty acids used by the body. It is found in cold water fatty fish and in fish oil supplements, along with docosahexaenoic acid (DHA). Omega-3 fatty acids are part of a healthy diet that helps lower risk of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812364|NCT00435045|Secondary|Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Docosahexaenoic Acid is an omega-3 essential fatty acid.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812365|NCT00435045|Secondary|Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period||Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812366|NCT00435045|Secondary|Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total cholesterol/High density lipoprotein cholesterol|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812367|NCT00435045|Secondary|Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein C-III (APOC3) is a very low density lipoprotein (VLDL) protein. APOC3 inhibits lipoprotein lipase and hepatic lipase; it is thought to delay catabolism of triglyceride-rich particles.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812368|NCT00435045|Post-Hoc|Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or bad cholesterol), which is responsible for carrying cholesterol to tissues."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812369|NCT00435045|Secondary|Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812370|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812371|NCT00435045|Secondary|Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812415|NCT00434759|Secondary|Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)|The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
2812372|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|LDL - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.|||percent change||Inter-Quartile Range|Median
2812373|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"HDL - A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.~High density lipoprotein cholesterol is the Total Cholesterol minus the sum of the LDL, VLDL and IDL."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812374|NCT00435045|Secondary|Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total Cholesterol is the sum of the High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL), and Intermediate Density Lipoproteins (IDL).|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812375|NCT00435045|Primary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 8|Modified Intent To Treat (MITT) Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.|||percent change||Inter-Quartile Range|Median
2812376|NCT00435019|Secondary|Observed Insulin Antibody Values|Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.|at 0 and 52 weeks|Safety analysis set (SAS): All randomised subjects exposed to at least one dose of trial product, classified according to actual treatment. In some cases, antibody samples were taken earlier than required. These results were not included. A shipment of antibody samples was lost during transportation, and thus these antibody data were missing.|||Percent bound of total||Standard Deviation|Mean
2812377|NCT00435019|Secondary|Number of Subjects Reporting Adverse Events|"Number of subjects reporting adverse events during the trial (from week -2 to week 52).~For details, please refer to the adverse events section."|from week -2 to week 52|Safety analysis set (SAS): all randomised subjects exposed to at least one dose of trial product, classified according to actual treatment.|||participants|||Number
2812378|NCT00435019|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.|after 52 weeks of treatment|Full Analysis Set (FAS) is defined as all randomised subjects exposed to at least one dose of trial product with a postbaseline observation, classified according to randomised treatment.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
2812379|NCT00434993|Secondary|Plasma Levels of IL-6 and IL-8 on Study Day 3|Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon's test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.|Measured at baseline and 3 days after randomization|Not all subjects had available data for secondary analyses and therefor the numbers will be less than the 152 (active) and 130 (placebo) arms.|||pg/ml||Standard Deviation|Log Mean
2812380|NCT00434993|Secondary|Hospital Mortality up to Day 60 in Subjects With Baseline Shock|Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 60 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.|||percentage of participants who died|||Number
2812381|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 28 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.|||days||Standard Error|Mean
2812382|NCT00434993|Secondary|Hospital Mortality to Day 60 in the Subset of Participants With ARDS|Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.|Determined 60 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.|||percentage of participants who died|||Number
2812416|NCT00434759|Secondary|Change From Baseline in Brief Symptom Inventory (BSI)|The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
2812383|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Participants With ARDS|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.|Determined 28 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.|||days||Standard Error|Mean
2812384|NCT00434993|Secondary|Number of Organ Failure-free Days at Day 28 Following Randomization|Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.|Daily from baseline to study day 28|Intent to treat.|||days||Standard Error|Mean
2812385|NCT00434993|Secondary|Number of ICU-free Days at 28 Days After Randomization|ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.|Determined 28 days after a subject entered the study|Intent to treat.|||days||Standard Error|Mean
2812386|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90|Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.|Determined 90 days after a subject entered the study|Intent to treat.|||percentage of participants who died|||Number
2812387|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60|Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.|Determined 60 days after a subject entered the study|Intent to treat population.|||percentage of participants who died|||Number
2812388|NCT00434993|Primary|Number of Ventilator Free Days (VFD)|Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.|Determined 28 days after a subject entered the study|All the intent to treat patients were analyzed. Data was available on all subjects for the primary analysis only.|||days||Standard Error|Mean
2812389|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks|||||||
2812390|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks|||||||
2812391|NCT00434967|Secondary|To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.||Baseline to 8 weeks|||||||
2812392|NCT00434967|Secondary|To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.||Baseline to 8 weeks|||||||
2812393|NCT00434967|Secondary|Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).||Baseline to 8 weeks|||||||
2812394|NCT00434967|Secondary|The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study|Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study|8 weeks||||participants|||Number
2812395|NCT00434967|Primary|Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)|Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.|8 weeks||||mm Hg||Standard Error|Least Squares Mean
2812396|NCT00434967|Primary|Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).|Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.|8 weeks||||mm Hg||Standard Error|Least Squares Mean
2812413|NCT00434759|Primary|Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)|The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
2812398|NCT00434954|Secondary|Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)|Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||scores on DTSQ scale||Standard Deviation|Mean
2812399|NCT00434954|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward|||kg/m^2||Standard Error|Least Squares Mean
2812400|NCT00434954|Secondary|Change in Body Weight|Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward|||kg||Standard Error|Least Squares Mean
2812401|NCT00434954|Primary|Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)|Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)|||Percentage of participants|||Number
2812402|NCT00434954|Secondary|Blood Lipid Levels|Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||mmol/L||Standard Deviation|Mean
2812403|NCT00434954|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles|7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||mg/dL||Standard Deviation|Mean
2812404|NCT00434954|Secondary|Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)|Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)|||Percentage of participants|||Number
2812405|NCT00434954|Secondary|Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)|Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)|||Percentage of participants|||Number
2812406|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 7.0%|Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||Percentage of participants|||Number
2812407|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 6.5%|Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward|||Percentage of participants|||Number
2812408|NCT00434954|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2812409|NCT00434876|Secondary|Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.|The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).|Baseline, and week 8||||minutes||Standard Deviation|Mean
2812410|NCT00434876|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.~The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9."|Baseline, weeks 4, and 9.||||units on a scale||Standard Deviation|Mean
2812411|NCT00434876|Secondary|Insomnia Severity Index (ISI)|ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.|Baseline, weeks 1, 3, 5, and 7 of treatment.||||units on a scale||Standard Deviation|Mean
2812412|NCT00434876|Primary|Sleep Efficiency (From an In-laboratory Polysomnogram)|The fraction of time spent asleep to the total time in bed (%).|Baseline, and week 8 of treatment.||||percentage||Standard Deviation|Mean
2812417|NCT00434759|Primary|Change From Baseline in Social Interaction Anxiety Scale (SIAS)|This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat|||units on a scale||Standard Deviation|Mean
2812418|NCT00434642|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event||From randomization through July 19, 2013 (up to 6 years, 3 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.|||Percentage of participants|||Number
2812419|NCT00434642|Secondary|Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)|A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.|||Percentage of participants|||Number
2812420|NCT00434642|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|From randomization through July 19, 2013 (up to 6 years, 3 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).|||Months||95% Confidence Interval|Median
2812421|NCT00434642|Secondary|Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response.|||Months||95% Confidence Interval|Median
2812422|NCT00434642|Secondary|Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).|||Percentage of participants|||Number
2812423|NCT00434642|Primary|Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).|||Months||95% Confidence Interval|Median
2812424|NCT00434590|Secondary|Chronic Rejection as Confirmed by Renal Biopsy at 12 Months||12 months|||||||
2812425|NCT00434590|Secondary|Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months||12 months|||||||
2812426|NCT00434590|Secondary|Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months||12 months|||||||
2812427|NCT00434590|Secondary|Serum Creatinine at 12 Months||12 months|||||||
2812428|NCT00434590|Secondary|Creatinine Clearance at 12 Months||12 months|||||||
2812429|NCT00434590|Primary|Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months|The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.|12 months|Study was terminated without analysis (small sample size).|||mL/min||Standard Deviation|Mean
2812430|NCT00434577|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 3 to Month 12|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36.|||Participants|||Count of Participants
2812431|NCT00434577|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.|||Participants|||Count of Participants
2812432|NCT00434577|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.|||Participants|||Count of Participants
2812594|NCT00433966|Primary|Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis|Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis|1 year||||Participants|||Count of Participants
2812433|NCT00434577|Secondary|Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes|Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.|From Month 3 up to Month 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36.|||Participants|||Count of Participants
2812434|NCT00434577|Secondary|Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes|Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.|||Participants|||Count of Participants
2812435|NCT00434577|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2812436|NCT00434577|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2812437|NCT00434577|Secondary|Number of German Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.|At one week post-vaccination 2 (Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.|||Participants|||Count of Participants
2812438|NCT00434577|Secondary|Number of German Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.|At one week post-vaccination 1 (Month 0)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.|||Participants|||Count of Participants
2812439|NCT00434577|Secondary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were albumin [ALB], alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], calcium [CAL], eosinophils [EOS], fibrinogen [FIB], haematocrit [HEM], hemoglobin [Hgb], leucocytes [LEU], lymphocytes [LYM], lactate dehydrogenate [LDH], monocytes [MON], neutrophils [NEU], partial thromboplastin time [PTPT], platelets [PLA], pro thrombin time [PTT], red blood cells [RBC], serum creatinine [SCREA], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.|At Day 0, Month 2 and Month 3|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.|||Participants|||Count of Participants
2812440|NCT00434577|Secondary|Frequency of VZV-specific Memory B-cells in a Subset of Subjects|Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older.|At pre-vaccination (Day 0) and at Month 3|The analysis was performed on the Total cohort for persistence at Month 12, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Month 12.|||B-cells/million cells||Standard Deviation|Mean
2812441|NCT00434577|Secondary|Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|At Months 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||mIU/mL||95% Confidence Interval|Geometric Mean
2812442|NCT00434577|Secondary|Anti-gE Specific Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Months 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2812443|NCT00434577|Secondary|Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.|At Month 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||T-cells/million cells||Standard Deviation|Mean
2812444|NCT00434577|Secondary|Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.|At Month 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||T-cells/million cells||Standard Deviation|Geometric Mean
2812445|NCT00434577|Secondary|Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker|Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.|At Months 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||T-cells/million cells||Standard Deviation|Mean
2812446|NCT00434577|Secondary|Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.|At Months 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||T-cells/million cells||Standard Deviation|Mean
2812447|NCT00434577|Secondary|Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers|Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.|At Months 12, 24 and 36|The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.|||T-cells/million cells||Standard Deviation|Mean
2812448|NCT00434577|Secondary|Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA.|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2812449|NCT00434577|Secondary|Anti-gE Specific Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2812450|NCT00434577|Secondary|Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812451|NCT00434577|Secondary|Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812452|NCT00434577|Secondary|Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker|Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812453|NCT00434577|Secondary|Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812454|NCT00434577|Secondary|Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers|Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812455|NCT00434577|Secondary|Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812456|NCT00434577|Secondary|Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells//million cells||Standard Deviation|Mean
2812457|NCT00434577|Secondary|Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker|Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812458|NCT00434577|Secondary|Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker|Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812459|NCT00434577|Secondary|Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers|Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old.|At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812460|NCT00434577|Primary|Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers|Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old.|One month after the second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Standard Deviation|Mean
2812461|NCT00434577|Primary|Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers|Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level.|One month after the second vaccination (Month 3)|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold Change||Standard Deviation|Mean
2812462|NCT00434577|Primary|Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers|Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥).|One month after the second vaccination (Month 3)|The analysis was performed on the According-to-Protocol(ATP) cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T-cells/million cells||Inter-Quartile Range|Median
2812480|NCT00434421|Primary|Proportion of Participants Who Discontinue Study|Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)|Initial placebo dose to end of 2-week treatment course (maximum study dose)|Safety Population: All study participants who were initiated onto the initial placebo study|||Percentage of Participants|||Number
2812463|NCT00434512|Secondary|Antibody Titers Against p17, p24, Nef, RT and F4co Antigens|Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).|At Month 0, Day 44, Month 2, Month 6 and Month 12|Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2812464|NCT00434512|Secondary|Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers|Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).|At Month 0, Day 44, Month 2, Month 6 and Month 12|Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.|||CD4+ T-cells/million T-cells||Standard Deviation|Mean
2812465|NCT00434512|Secondary|Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker|Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).|At Month 0, Day 44, Month 2, Month 6 and Month 12|Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.|||CD4+ T-cells/million T-cells||Standard Deviation|Mean
2812466|NCT00434512|Primary|Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens|Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.|At Day 44|Analysis was performed on the According-to-Protocol cohort for Immunogenicity that included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with procedures and intervals defined in protocol, with no elimination criteria during study) for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2812467|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Month 12|The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccination administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812468|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Month 9|The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812469|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Month 6|The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812470|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Month 2|The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812471|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Day 44|The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812472|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Month 1|The analysis was preformed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812473|NCT00434512|Primary|Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0|The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].|At Month 0|The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812474|NCT00434512|Primary|Number of Subjects With Serious Adverse Events (SAEs) and Related SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (From Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812475|NCT00434512|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination (across doses)|The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812476|NCT00434512|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)|The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812477|NCT00434512|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)|The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2812478|NCT00434434|Secondary|Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.|From baseline to Week 16|Modified ITT population|||ratio of FEV1||Full Range|Median
2812479|NCT00434434|Primary|Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)|The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.|From baseline to Week 16|Modified intent-to-treat (ITT) population|||concentration change||Full Range|Median
2812481|NCT00434356|Secondary|Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients|||participants|||Number
2812484|NCT00434356|Secondary|Grade ≥ 3 Adverse Events (AEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE|30 days following the last administration of study treatment|Treated patients|||participants|||Number
2812485|NCT00434356|Secondary|Serious Adverse Events (SAEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|30 days following the last administration of study treatment|Treated patients|||participants|||Number
2812486|NCT00434356|Primary|Best Response|The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence (by patient)|Randomized patients with at least one scan available at baseline and post-baseline|||participants|||Number
2812487|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population|||percentage of participants|||Number
2812488|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population|||percentage of participants|||Number
2812489|NCT00434330|Other Pre-specified|Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population|||percentage of participants|||Number
2812490|NCT00434330|Primary|Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.|The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.|Baseline and Weeks 2-29|Modified intent-to-treat (mITT) population|||g/dL||Standard Deviation|Mean
2812491|NCT00434304|Secondary|Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||beats per minute (bpm)||Standard Deviation|Mean
2812492|NCT00434304|Secondary|Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2812493|NCT00434304|Secondary|Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||participants|||Number
2812494|NCT00434304|Secondary|Urinalysis Data|The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.|Screening, Week 16, and Week 52|Safety Population: Screening Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants|||participants|||Number
2812495|NCT00434304|Secondary|Change From Baseline in Red Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||tera per Liter (TI/L)||Standard Deviation|Mean
2812496|NCT00434304|Secondary|Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||giga per Liter (GI/L)||Standard Deviation|Mean
2812497|NCT00434304|Secondary|Change From Baseline in Hematocrit at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||proportion of 1 (SI)||Standard Deviation|Mean
2812595|NCT00433966|Primary|Stent Arm - Ischemic Target Lesion Revascularization|Number of Participants With Ischemic Target Lesion Revascularization|1 year||||Participants|||Count of Participants
2812498|NCT00434304|Secondary|Change From Baseline in Prolactin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||micrograms per Liter (MCG/L)||Standard Deviation|Mean
2812499|NCT00434304|Secondary|Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||millimoles per Liter (MMOL/L)||Standard Deviation|Mean
2812500|NCT00434304|Secondary|Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||micromoles per Liter (UMOL/L)||Standard Deviation|Mean
2812501|NCT00434304|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||international units per Liter (IU/L)||Standard Deviation|Mean
2812502|NCT00434304|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants|||grams per Liter (G/L)||Standard Deviation|Mean
2812503|NCT00434304|Secondary|Percentage of Participants Who Remained in the Study on the Indicated Days|The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.|Days 0-364|FAS. Participants dropped out of the study each week.|||percentage of participants|||Number
2812504|NCT00434304|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale|"CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Weeks 1-52|FAS. Participants dropped out of the study each week.|||participants|||Number
2812505|NCT00434304|Secondary|Summary of the Modified Hoehn & Yahr Criteria Stages|Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).|Screening-Week 52|FAS. Participants dropped out of the study each week.|||points on a scale|||Number
2812506|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
2812507|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812508|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 0-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812509|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
2812510|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812511|NCT00434304|Primary|Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites|Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.|Weeks 1-16|PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.|||pg/mL||Standard Deviation|Mean
2812512|NCT00434304|Primary|Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.|Weeks 5-16|PK Population|||hours||90% Confidence Interval|Median
2812513|NCT00434304|Primary|Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.|Weeks 5-16|PK Population|||hours*pg/mL||95% Confidence Interval|Geometric Mean
2812514|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812515|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
2812516|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812517|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part I|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812518|NCT00434304|Secondary|Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III|A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percentage of responders|||Number
2812519|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||percent change||Standard Deviation|Mean
2812520|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812521|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part III|The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|Full Analysis Set (FAS): all participants who progressed to the treatment phase, excluding those who did not fulfill major registration criteria, those who had not received at least one dose of the investigational drug, and those whose measured data were not available after treatment initiation. Participants dropped out of the study each week.|||points on a scale||Standard Deviation|Mean
2812522|NCT00434304|Primary|Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.|Weeks 5-16|Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.|||picograms/milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2812523|NCT00434278|Secondary|Change in Pulmonary Function as Measured by FEV1 and FVC|FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) were recorded at Day 0 (baseline) and Day 14. Change in FEV1 and FVC from baseline to Day 14 was reported as a percentage of values predicted for age, height, and race.|From baseline to Day 14|Randomized patients. Patients not included in this analysis did not meet ATS reproducibility criteria. Two patients in the placebo arm whose screening visit values did not meet ATS reproducibility criteria were randomized in error and completed the study.|||Percentage of predicted value||Standard Deviation|Mean
2812524|NCT00434278|Primary|Change in Distance Walked in the 6-minute Walk Test|Change in distance walked was defined as (distance walked in 6 minutes at baseline [Day 0]) − (distance walked in 6 minutes at Day 14) in meters.|From baseline to Day 14|Randomized patients. For placebo arm: 2 placebo patients who were randomized did not complete the study and therefore had no values to calculate change from baseline computation.|||Meters||Standard Deviation|Mean
2812525|NCT00434252|Secondary|Number of Participants With Select Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade >= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade >= 3), neutropenia (Grade >= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade >= 3).~*All serious adverse events are listed in the Adverse Event Reporting section."|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.|The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.|||participants|||Number
2812526|NCT00434252|Secondary|Twenty−Four Week Landmark Stable Disease|"As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.~The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day."|24 weeks|Intent-to-treat (randomized) patients|||percentage of participants||95% Confidence Interval|Number
2812527|NCT00434252|Secondary|Six-month Landmark Survival Rate|Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan−Meier method.|6 months|Intent-to-treat (randomized) population|||percentage of participants||95% Confidence Interval|Number
2812528|NCT00434252|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.|Up to 102 weeks|Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response|||months||95% Confidence Interval|Median
2812529|NCT00434252|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.~The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution."|Up to 102 weeks|Randomized Patients with Measurable Disease at Baseline|||percentage of participants||95% Confidence Interval|Number
2812530|NCT00434252|Secondary|Number of Participants With Objective Response|Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.|Up to 102 weeks|Intent-to-treat (randomized) population.|||participants|||Number
2812531|NCT00434252|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan−Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.|Up to 102 weeks|Intent-to-treat (randomized) population|||months||95% Confidence Interval|Median
2812532|NCT00434252|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan−Meier method.|From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.|Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.|||months||95% Confidence Interval|Median
2812533|NCT00434226|Secondary|Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
2812534|NCT00434226|Secondary|Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
2812535|NCT00434226|Secondary|Incidence of Grade ≥ 3 Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
2812536|NCT00434226|Secondary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients|||participants|||Number
2812537|NCT00434226|Primary|Best Response|The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence|Randomized patients with at least one scan available at baseline and post-baseline|||participants|||Number
2812538|NCT00434213|Secondary|Contact Sensitization to Methylphenidate|Contact sensitization to methylphenidate through skin patch testing.|7 weeks|Safety population|||Participants|||Number
2812539|NCT00434213|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|7 weeks|Safety population|||Participants|||Number
2812540|NCT00434161|Secondary|Incidence of Second Primary Malignancies or Other Malignancies|All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit - yes, no, no assessment -, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.|During long-term follow up phase (maximum of 10 years)|total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.|||participants|||Number
2812541|NCT00434161|Secondary|Time Death or Disease Progression|For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.|||months||Inter-Quartile Range|Median
2812542|NCT00434161|Secondary|Progression Free Survival|Progression-free survival (PFS) is the length of time during and after the treatment during which the disease being treated does not get worse. In this study the event for Progression-free survival was death from all causes or disease progression. Time to each event was defined as the time elapsed between the date of the first dose of investigational product, and the date of the given event.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.|||Months||Inter-Quartile Range|Median
2812543|NCT00434161|Primary|Incidence of Cataract Development or Progression at Month 12.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|12 months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.|||Participants|||Number
2812544|NCT00434161|Secondary|Overall Survival|Overall survival (OS) is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47|||Months||Inter-Quartile Range|Median
2812545|NCT00434161|Secondary|Incidence of Adverse Events and Laboratory Abnormalities|Incidence of Adverse Events CTCAE grade 3 or higher reported|at Day 32||||Participants|||Number
2812546|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.|To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Month 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||participants|||Number
2812547|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 6|To study if the treatment has effected on the visual acuity from baseline to months 6, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||participants|||Number
2813311|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index for Age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose body mass index for age z-scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
2812548|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 12.|"To study the change in cataract from baseline visit to months 12, regarding the three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||units on a scale||Standard Deviation|Mean
2812549|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.|"To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale.~To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.|||units on a scale||Standard Deviation|Mean
2812550|NCT00434161|Secondary|Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12|"To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference."|at Month 6 and Month 12|281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 [77.3%] in the placebo, 52/79 [65.8%] in the palifermin. Month 12: 66 completed (14/22 [63.6%] in the placebo, 52/79 [65.8%] in the palifermin group.|||participants|||Number
2812551|NCT00434161|Secondary|Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|6 Months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.|||participants|||Number
2812552|NCT00434161|Secondary|The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.|"The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32."|at Day 32||||units on a scale * days||Standard Deviation|Mean
2812553|NCT00434161|Secondary|Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The duration of ulcerative mucositis measured the number of days the participants had different WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally. Patients that did not have any ulcerative mucositis were given a value of 0 days."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.|||Days||Full Range|Mean
2812596|NCT00433966|Primary|Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events|Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).|30 Days||||Participants|||Count of Participants
2812554|NCT00434161|Secondary|Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.|||participants|||Number
2812555|NCT00434161|Primary|Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)|"For the primary efficacy endpoint maximum severity of Oral Mucositis (OM) was assessed, the number of participants who had the different severity. To assess severity of OM, a 5-grade WHO scale (0, 1, 2, 3, or 4) was used.~0 = no findings or erythema only, 1= soreness present with or without erythema, 2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects, and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.|||Participants|||Number
2812556|NCT00434148|Secondary|Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score|"A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing's Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. 1 corresponds to the response category Always or Very much and 5 corresponds to the category Never or Not at all. The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement."|baseline, 3 months, 6 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage change in HRQL score||Standard Deviation|Mean
2812557|NCT00434148|Secondary|Change From Baseline in Tumor Volume|Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.|baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||cm^3||Standard Deviation|Mean
2812558|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition|Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage of body fat||Standard Deviation|Mean
2812559|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)|BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||mg/cm^3||Standard Deviation|Mean
2812560|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score|The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score >= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60||||score on a scale||Standard Deviation|Mean
2812561|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score|"The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows:~0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement."|baseline, month 3, month 6, month 12, month 18, month 24|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||score on a scale||Standard Deviation|Mean
2812562|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides|Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||mmol/L||Standard Deviation|Mean
2812563|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference|Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||cm||Standard Deviation|Mean
2812564|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)|BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||kg/m^2||Standard Deviation|Mean
2812565|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2812566|NCT00434148|Secondary|Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)|Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||percent change||Standard Deviation|Mean
2812567|NCT00434148|Secondary|Percent Change From Baseline in Serum Cortisol|Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
2812568|NCT00434148|Secondary|Time to First UFC Response|Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.|12 months|Full Analysis Set (FAS): The full analysis set included all randomized participants who received at least one dose of study drug.|||months||Inter-Quartile Range|Median
2812569|NCT00434148|Secondary|Change From Baseline in mUFC|Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.|baseline, 3 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.|||nmol/24h||Standard Deviation|Mean
2812570|NCT00434148|Primary|Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group|A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.|6 months|The full analysis set (FAS) was the primary population for efficacy and consisted of all 162 randomized patients who received at least one dose of paseriotide.|||Responders||95% Confidence Interval|Number
2812571|NCT00434122|Secondary|Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)|An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day.|7 days after hCG injection|Subjects with evaluable endometrial biopsies 7 days after injection with hCG.|||Participants|||Number
2812572|NCT00434122|Primary|Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)|"Explanation of the term coefficient of variation: The coefficient of variation is a normalized measure of dispersion of a probability distribution."|Stimulation Day 1||||Percentage||Standard Deviation|Mean
2812573|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at 4 Years|Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|48 months|All Participants|||percentage of participants||95% Confidence Interval|Number
2812574|NCT00434109|Secondary|Number of Participants Requiring Dose Reduction|Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.|12 months|All participants|||participants|||Number
2812575|NCT00434109|Secondary|Number of Participants With Biochemical Response|Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.|12 months|All Participants|||participants|||Number
2812576|NCT00434109|Secondary|Number of Participants With Partial Radiographic Response|Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD.|12 months|All Participants|||participants|||Number
2812577|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at One Year|Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|12 months|All participants|||percentage of participants||95% Confidence Interval|Number
2812578|NCT00434109|Primary|Percentage of Participants With Progression Free Survival (PFS) at 12 Months|Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started.|12 months|All participants|||percentage of participants||95% Confidence Interval|Number
2812579|NCT00434057|Secondary|Exploratory Analyses||Within 365 days of Data Lock||2010-02-28|02/2010||||
2812582|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Economic Self-Sufficiency subscale measures the ability to sustain customary socio-economic activity and independence.|long term (1 year)||||units on a scale||Standard Deviation|Mean
2812583|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Social Integration Subscale measures the ability to participate in and maintain customary social relationships.|long term (1 year)||||units on a scale||Standard Deviation|Mean
2812584|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Occupation Subscale measures the ability to occupy time in the manner customary to that person's sex, age, and culture.|long term (1 year)||||units on a scale||Standard Deviation|Mean
2812585|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Mobility Subscale measures the ability to move about effectively in his/her surroundings.|long term (1 year)||||units on a scale||Standard Deviation|Mean
2812586|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Physical Independence subscale measures the ability to sustain a customarily effective independent existence.|long term (1 year)||||units on a scale||Standard Deviation|Mean
2812587|NCT00434018|Primary|Wheelchair Skills Test (WST)|The WST is a standardized evaluation method that permits a set of representative wheelchair skills to be objectively, simply and inexpensively documented. The WST is an instrument for the objective evaluation of wheelchair skills. The WST consists of a series of commonly used wheelchair skills spanning the spectrum from those as basic as applying brakes to those as difficult as climbing curbs and performing wheelies. The WSC encompasses 57 skills (in Version 4.1) which result in a total score. The WST provide a pass-fail score for each skill. Refusal to attempt a skill (e.g. because of fear) constitutes a failing grade. The numerator is the Total Raw Score (i.e., the number of individual skills awarded a passing score) and the denominator is the number of applicable skills (i.e., the total number of skills minus those awarded NP scores). 100% is the maximum possible percentage score.|long term (1 year)||||units on a scale||Standard Deviation|Mean
2812588|NCT00433992|Secondary|Change in Fat Apoptosis|Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry|Entry, Week 48||||g||Inter-Quartile Range|Median
2812589|NCT00433992|Primary|Change in Mitochondrial Activity|mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.|Entry, Week 96||||copies/cell||Inter-Quartile Range|Median
2812590|NCT00433966|Secondary|Pharmacology Arm - Major Adverse Cardiovascular Events|Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)|3 years||||Participants|||Count of Participants
2812591|NCT00433966|Secondary|Stent Arm - Segment Binary Angiographic Restenosis|Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).|13 months||||Participants|||Count of Participants
2812592|NCT00433966|Secondary|Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding|Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)|30 days||||Participants|||Count of Participants
2812597|NCT00433914|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.|||Number of subjects|||Number
2812598|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Percentage of subjects||95% Confidence Interval|Number
2812599|NCT00433914|Secondary|Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||µg/mL||95% Confidence Interval|Geometric Mean
2812600|NCT00433914|Secondary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2812601|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Percentage of subjects||95% Confidence Interval|Number
2812602|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.|||Percentage of subjects||95% Confidence Interval|Number
2812603|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.|||Percentage of subjects||95% Confidence Interval|Number
2812604|NCT00433836|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients|The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.|Baseline and Week 8|A subset of approximately 100 - 150 patients from selected centers was expected to undergo Ambulatory Blood Pressure Monitoring at baseline (Week 0) and at Week 8; however, only 56 patients chose to participate in this aspect of the study.|||mm Hg||Standard Deviation|Mean
2812605|NCT00433836|Secondary|Decrease in MSSBP to < 95th Percentile for Age, Gender and Height|The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.|at week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.|||Percentage of participants|||Number
2812606|NCT00433836|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.|||mm Hg||Standard Error|Least Squares Mean
2812607|NCT00433836|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.|||mm Hg||Standard Error|Least Squares Mean
2812608|NCT00433771|Secondary|Number of Device-Related Adverse Events|Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.|Until 6 months or death|The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.|||Events|||Number
2812610|NCT00433771|Secondary|Stent Patency at 6 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).|6 Months|23 patients reached the Month 6 follow up point and were evaluated for stent patency.|||Participants|||Number
2812611|NCT00433771|Secondary|Stent Patency at 3 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).|3 Months|34 patients reached the Month 3 follow up point and were evaluated for stent patency.|||Participants|||Number
2812612|NCT00433771|Secondary|Stent Patency at 1 Month|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.|1 month|45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.|||Participants|||Number
2812613|NCT00433771|Secondary|Bilirubin Level Reduction|Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.|1 month|45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.|||Participants|||Number
2812614|NCT00433771|Secondary|Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.|6 months|23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.|||Participants|||Number
2812615|NCT00433771|Secondary|Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.|3 months|34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.|||Participants|||Number
2812616|NCT00433771|Secondary|Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.|1 Month|49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.|||Participants|||Number
2812617|NCT00433771|Secondary|Re-interventions|Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.|Until 6 months or death|The re-intervention rate was assessed in the evaluable cohort of 55 patients.|||Participant|||Number
2812618|NCT00433771|Secondary|Ability to Successfully Remove a Stent Upon Removal Attempt|The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.|6 months|2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.|||Participants|||Number
2812619|NCT00433771|Secondary|Technical Success|Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.|At treatment|Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients|||participants|||Number
2812620|NCT00433771|Primary|Adequate Clinical Palliation of the Biliary Obstruction|Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.|6 months|Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.|||participants|||Number
2812621|NCT00433745|Secondary|Disease Response|Clinical response of underlying malignancy to the vaccination|7 weeks after last dose of vaccine||||participants|||Number
2812622|NCT00433745|Primary|Cellular Immune Response|Minimum criterion for a cellular immune response was defined as the emergence of detectable T cell frequency against Willm's tumor 1 (WT1) when the pre-study analysis found no response, or a twofold increase in T cell frequency at any post vaccination time point|7 weeks after last dose of vaccine||||participants|||Number
2812623|NCT00433654|Secondary|Ventricular Sensed Amplitude|Average ventricular sensed amplitude.|3 or 4 months post-implant||||millivolt (mV)||Standard Deviation|Mean
2812624|NCT00433654|Secondary|Atrial Sensed Amplitude|Average atrial sensed amplitude.|3 or 4 months post-implant||||millivolt (mV)||Standard Deviation|Mean
2812625|NCT00433654|Secondary|Ventricular Pacing Capture Threshold|Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant||||Volts||Standard Deviation|Mean
2812627|NCT00433654|Secondary|Ventricular Lead Handling Rating|Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included|||Units on a scale||Standard Deviation|Mean
2812628|NCT00433654|Secondary|Atrial Lead Handling Rating|Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included|||Units on a scale||Standard Deviation|Mean
2812629|NCT00433654|Secondary|Ventricular Lead Impedance Change|Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included|||ohms||Standard Deviation|Mean
2812630|NCT00433654|Secondary|Atrial Lead Impedance Change|Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included|||ohms||Standard Deviation|Mean
2812631|NCT00433654|Secondary|Occurrence of Arrhythmias|Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan|During the MRI scan|Arrhythmia was defined as heart rate > 150 beats per minute for > 30 seconds. Asystole was defined as standstill 6 seconds in electrical activity of the heart. Episodes were assessed via pulse oximetry monitoring during MRI scans.|||participants|||Number
2812632|NCT00433654|Secondary|System Related Adverse Device Effects Due to Labeling Instructions|Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.|Implant through 18 months post-implant|Includes all subjects undergoing an MRI using the instructions in the protocol.|||participants|||Number
2812633|NCT00433654|Secondary|Subjects With System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to 4 Months|All implanted subjects with either a 4-month follow-up or a system-related complication within the first 4 months post-implant are included.|||participants|||Number
2812634|NCT00433654|Primary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week ventricular sensed amplitude was less than 5.0 mV.|||participants|||Number
2812635|NCT00433654|Primary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.|||participants|||Number
2812636|NCT00433654|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.|||participants|||Number
2812637|NCT00433654|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.|||participants|||Number
2812638|NCT00433654|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.|MRI scan to one-month post-MRI scan|Subjects who underwent an MRI scan following study protocol-specified instructions are included. Of the 243 subjects who completed a one-month post-MRI (4-month) visit, 32 did not complete the MRI scan according to the protocol instructions, and are not included.|||participants|||Number
2812639|NCT00433550|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||months||95% Confidence Interval|Median
2812640|NCT00433550|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.|Up to 2 years|All patients who achieved a CR or PR are included in this analysis.|||months||95% Confidence Interval|Median
2812641|NCT00433550|Secondary|Progression Free Survival|Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||months||95% Confidence Interval|Median
2812642|NCT00433550|Secondary|Overall Survival|Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Up to 2 years|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||months||95% Confidence Interval|Median
2812643|NCT00433550|Primary|Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)|Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|36 weeks|One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.|||proportion of patients||95% Confidence Interval|Number
2812644|NCT00433537|Secondary|3-year Overall Survival (OS)|OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT|||probability||95% Confidence Interval|Number
2812645|NCT00433537|Secondary|2-year Progression-free Survival (PFS)|PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT|||probability||95% Confidence Interval|Number
2812646|NCT00433537|Primary|Complete Response (CR) Rate|Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.|Assessed after VcR-CVAD cycles 2, 4, and 6.|Eligible and treated patients|||proportion||95% Confidence Interval|Number
2812647|NCT00433511|Secondary|The Association Between IDFS and Genotype|Invasive disease-free survival (IDFS) is defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation. Three-year IDFS rate was reported by genetic ancestry and IDFS was compared between patients with European ancestry and patients with African ancestry.|Assessed at 3 years|Only patients with genetic ancestry as European ancestry or African ancestry were included in the analysis.|||proportion of participants||95% Confidence Interval|Number
2812648|NCT00433511|Secondary|5-year Overall Survival (OS)|Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive.|Assessed at 5 years|All randomized patients at Step 1|||proportion of participants||95% Confidence Interval|Number
2812649|NCT00433511|Primary|Invasive Disease-free Survival (IDFS) Rate at 5 Years|Invasive disease-free survival (IDFS) was defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation.|Assessed at 5 years|All randomized patients at Step 1|||proportion of participants||95% Confidence Interval|Number
2812650|NCT00433446|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2812651|NCT00433446|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. PSA = .2 ng/ml. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression|All eligible patients with measurable disease who started treatment were included in the analysis|||participants|||Number
2812652|NCT00433446|Secondary|Overall Survival (OS)|Measured from date of registration to date of death due to any cause or last contact|0-3 yeas after registration|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
2812653|NCT00433446|Primary|Confirmed Prostate-Specific Antigen (PSA) Response|PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2812654|NCT00433446|Secondary|Progression-free Survival (PFS)|PFS is defined as tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, PSA progression by PSA Working Group criteria, or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
2812655|NCT00433381|Secondary|Change in Perfusion MRI Markers at Week 16 as Predictors of 12mo Overall Survival (OS)|To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 16 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 16 are the prognostic indicators.|Baseline and 16 Weeks|Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention|||Area Under the Curve (AUC)||95% Confidence Interval|Number
2812656|NCT00433381|Secondary|Change in Perfusion MRI Markers at Week 8 as Predictors of 12mo Overall Survival (OS)|To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 8 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 8 are the prognostic indicators.|Baseline and 8 weeks|Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention|||Area Under the Curve (AUC)||95% Confidence Interval|Number
2812657|NCT00433381|Secondary|Change in Perfusion MRI Markers at Week 2 as Predictors of 12mo Overall Survival (OS)|To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 2 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 2 are the prognostic indicators.|Baseline and 2 Weeks|Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention|||Area Under the Curve (AUC)||95% Confidence Interval|Number
2812658|NCT00433381|Secondary|Predictive Value of CBV and Lac/NAA in Assessing 6-month Progression-free Survival|Aim not included in final (February 10, 2009) protocol (removed from section 2)|2 weeks following initiation of protocol treatment (T1)|This Aim was removed from the approved protocol aims. Data were not collected.||||||
2812659|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response|Aim not included in final (February 10, 2009) protocol (removed from section 2)|2 weeks following initiation of protocol treatment (T1)|This Aim was removed from the approved protocol aims. Data were not collected.||||||
2812660|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio|Aim not included in final (February 10, 2009) protocol (removed from section 2).|2 weeks following initiation of protocol treatment (T1) and at 8 weeks following chemotherapy with bevacizumab (T2)|This Aim was removed from the approved protocol aims. Data were not collected.||||||
2812661|NCT00433381|Secondary|Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard|Local reads were treated as the test and central reads were treated as the reference standard. Thus, a participant meeting the definition of progression on any standard MRI central interpretation (baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment) was considered positive for PFS-6. Therefore, a true positive is defined as a positive local interpretation for a subject with a positive central read.|baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment|Standard of care MRI occurred at baseline, after every 2 cycles of treatment (every 8 weeks), and after completion/termination of treatment. Subjects participated in the MR substudies regardless of therapeutic intervention|||Participants|||Count of Participants
2812662|NCT00433381|Secondary|Agreement Between Local Interpretation and Central Interpretation of Standard MRI|Local and central interpretations of the standard MRI were assessed for progression and survival at all available imaging (baseline visit, week 2, and after every 2 cycles of treatment, and at termination of treatment). Patients who suffer clinical progression without radiographic confirmation of progression were considered to have progressive disease in determination of PFS-6. Subjects participated in the MR substudies regardless of therapeutic intervention|baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment|Of the 123 subject accrued to ACRIN 6677, 103 were analyzable for this aim. Reasons for exclusions were as follows: 11 subjects only had baseline imaging, 4 were ineligible, 1 was lost to followup, and 4 had incomplete/uninterpretable images.|||Participants|||Count of Participants
2812663|NCT00433381|Secondary|Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)|Tumor size measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Stable disease (SD): Does not qualify for CR, PR, or PD.|From randomization to death or last follow-up. Patients were followed up to 62.9 months.|Eligible patients with measurable disease at baseline|||Participants|||Count of Participants
2812664|NCT00433381|Secondary|Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm|Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.|From randomization to six months.|Eligible patients with six-month data.|||Participants|||Count of Participants
2812665|NCT00433381|Primary|Number of Participants With Predicted Overall Survival (OS) at 12 Months|"Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 12-month overall survival (OS).~Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to death, evaluated at 96wks, is the determinate of OS at 12 months. Subjects will not be analyzed by arm."|2 and 8 weeks posttreatment, and every 2 months until 96wks|A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI. Subjects participated in the MR substudies regardless of therapeutic intervention|||Participants|||Count of Participants
2812666|NCT00433381|Primary|Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6)|Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 6-month progression-free survival (PFS-6) over all study participants. Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to progression, evaluated at 96wks, is the determinate of PFS at 6months (PFS-6). Subjects will not be analyzed by arm.|2 and 8 weeks posttreatment, and every 2 months until 96wks|"A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI.~Of 123 main subjects, a subset of 20 consented to the MRS substudy, of whom 13 had analyzable MRS datasets. this subset is independent of Study Arm."|||Participants|||Count of Participants
2812667|NCT00433381|Primary|Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm)|This endpoint determines tolerability of this treatment arm. If tolerable, then the secondary endpoint of treatment efficacy for this arm occurs. Percentage is calculated by taking the number of patients who did not stop bevacizumab and temozolomide treatment due to medical complications in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who did not begin treatment.|From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor).|The first 29 eligible patients who received protocol treatment were to be evaluated for treatment tolerability.|||Participants|||Count of Participants
2812668|NCT00433381|Primary|Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm|Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.|From randomization to six months.|Eligible patients with six-month data.|||Participants|||Count of Participants
2812669|NCT00433329|Primary|Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters|The 6MWT is a non encouraged test, which measures the walking distance covered over a 6 minute period|at 16 weeks and at 28 weeks of a stepped approach to therapy|Intention to treat population|||participants||95% Confidence Interval|Number
2812670|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation in Nonresponders|Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.|over 13 Weeks|Number of randomized participants who were nonresponders at Visit 4 (7 weeks).|||participants|||Number
2812671|NCT00433290|Secondary|Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint|Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.|13 Weeks|Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values.|||participants|||Number
2812672|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders|"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).~Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score."|Baseline and 13 Weeks|Number of participants who did not respond to treatment after 6 weeks of treatment.|||units on a scale||Standard Deviation|Mean
2812673|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||kilograms||Standard Deviation|Mean
2812674|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.|||mm Hg||Standard Deviation|Mean
2812679|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812680|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812681|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812682|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812683|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812684|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812685|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812686|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity|A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812687|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812688|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812689|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812690|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812691|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)|A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812692|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|All randomized participants. Intent-to-treat analysis.|||units on a scale||Standard Deviation|Mean
2812719|NCT00433160|Secondary|Back Pain Severity|Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, Weeks 12, 24, 36, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||participants|||Number
2812693|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812694|NCT00433290|Secondary|Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores|MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812695|NCT00433290|Secondary|Number of Participants Who Responded to Treatment at 13 Week Endpoint|Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|13 Weeks|Number of randomized participants with non-missing response values.|||participants|||Number
2812696|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812697|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores|This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812698|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812699|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812700|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812701|NCT00433290|Secondary|Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|All randomized participants with at least one non-missing post-baseline value.|||units on a scale||Standard Deviation|Mean
2812702|NCT00433290|Primary|Change in Brief Pain Inventory (BPI) 24-hour Average Rating|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.|Baseline, Week 4, Week 7, Week 13|All randomized participants. Intent-to-treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2812703|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.|The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 364|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.|||Percentage of subjects||95% Confidence Interval|Number
2812704|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.|The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 266|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.|||Percentage of subjects||95% Confidence Interval|Number
2812705|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.|Day 182|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.|||Percentage of subjects||95% Confidence Interval|Number
2812872|NCT00432562|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0-144 hours post dose||||hours||Standard Deviation|Mean
2812706|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results|Day 56|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.|||Percentage of subjects||95% Confidence Interval|Number
2812707|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results|Day 14|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.|||Percentage of subjects||95% Confidence Interval|Number
2812708|NCT00433199|Primary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112|Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results|Day 112|The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112;|||Percentage of subjects||95% Confidence Interval|Number
2812709|NCT00433160|Secondary|Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks|Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.|||participants|||Number
2812710|NCT00433160|Secondary|Fractures by Investigators Assessment During Entire Study Period of 104 Weeks|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline Through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||number of fractures|||Number
2812711|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks|Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.|||number of fractures|||Number
2812712|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in CTX||Standard Deviation|Mean
2812713|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BAP||Standard Deviation|Mean
2812714|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in PINP||Standard Deviation|Mean
2812715|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812716|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812717|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812718|NCT00433160|Secondary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812720|NCT00433160|Secondary|Fractures by Investigators Assessment|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline through 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||number of fractures|||Number
2812721|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment|Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 52 weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures.|||number of fractures|||Number
2812722|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)|Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in CTX||Standard Deviation|Mean
2812723|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BAP||Standard Deviation|Mean
2812724|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, and 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.|||percent change in PINP||Standard Deviation|Mean
2812725|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812726|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812727|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812728|NCT00433160|Primary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline to 52 weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.|||percent change in BMD||Standard Deviation|Mean
2812729|NCT00433147|Secondary|Change From Baseline To End Of Treatment In Beta-glucocerebrosidase (GCase) Levels In White Blood Cells (WBC)|GCase is a biomarker used to assess the PD effects of afegostat tartrate. Blood samples were collected to assess GCase levels in WBC. The baseline value was defined as the last non-missing value before the start of study drug.|Baseline, Day 28|PD Population: All participants who were included in the Safety Population and had a baseline and at least 1 post-baseline PD measurement.|||pmol/mg/min||Standard Deviation|Mean
2812730|NCT00433147|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) with a start date on or after administration of the study drug (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through 7 days after the last dose of study drug (Day 35) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Day 35|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2812731|NCT00433017|Secondary|Mean Change in Central Retinal Thickness of the Study Eye at Month 12|Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.|Baseline and Month 12|Full analysis set, LOCF|||μm||Standard Deviation|Mean
2812732|NCT00433017|Secondary|Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12|Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.|Baseline and Month 12|Full analysis set based on observed data.|||mm^2||Standard Deviation|Mean
2812733|NCT00433017|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|The Full Analysis Set (FAS) based on observed data.|||Percentage of participants|||Number
2812734|NCT00433017|Primary|Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 to Month 11|Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment.|||Percentage of Participants|||Number
2812735|NCT00433017|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye.|||Letters||Standard Deviation|Mean
2812736|NCT00433004|Primary|PLAN B USE||1 year||||Participants|||Count of Participants
2812737|NCT00433004|Primary|PREGNANCY RATES||1 year||||Participants|||Count of Participants
2812738|NCT00433004|Primary|ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.||1 year||||Participants|||Count of Participants
2812739|NCT00432991|Primary|Post-Operation Nausea Score|"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea two times after the conclusion of their surgery: 1) upon arrival in the PACU, and 2) immediately prior to discharge from the PACU.~The numbers given by the subject were then averaged to determine the average level of nausea post-operative for each subject."|post-operation||||units on a scale||Standard Deviation|Mean
2812740|NCT00432991|Primary|Subject's Self-rated Intra-operative Nausea Level on a Scale of 0-3, Where 0=no Nausea, 1=Mild Nausea, 2=Moderate Nausea, and 3=Severe Nausea.|"Subjects were asked to rate their nausea level on a scale of 0-3, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea, five times during their procedure: 1) Immediately prior to skin incision, 2) immediately following delivery of the baby, 3) following reinternalization of the uterus, 4) following closure of the fascia, 5) following closure of the skin.~The numbers given by the subject were then averaged to determine the average level of nausea intra-operatively for each subject."|intra-operation||||units on a scale||Standard Deviation|Mean
2812741|NCT00432991|Primary|Pre-Induction Nausea Score|Subject's self-rated nausea level on a scale of 0-3 immediately prior to induction of spinal anesthesia, where 0=no nausea, 1=mild nausea, 2=moderate nausea, and 3=severe nausea|immediately pre-induction||||units on a scale||Standard Deviation|Mean
2812742|NCT00432965|Primary|Incidence of Complete Ulcer Closure Closure.||Days 0-114|Analysis of this endpoint was based on the Intent-to-Treat (ITT population). Subjects who signed an informed consent and were randomized, but failed to undergo their assigned randomized treatment, were included in this population.|||Participants|||Count of Participants
2812743|NCT00432835|Primary|Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis|Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.|Study Day 0 (Baseline), Day 4, Day 8||||percentage of radiolabeled meal in stoma||Standard Error|Mean
2812744|NCT00432835|Primary|Symptom of Nausea Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7||||Patient Self-reported Symptom Score||Standard Error|Mean
2812745|NCT00432835|Primary|Symptom of Vomiting Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7||||Patient Self-reported Symptom Score||Standard Error|Mean
2812746|NCT00432809|Secondary|Cardiovascular Medications - Anticoagulants|Number of participants taking anticoagulants at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812747|NCT00432809|Secondary|Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)|Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812748|NCT00432809|Secondary|Cardiovascular Medications - Beta Blocker|Number of participants taking Beta Blockers at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812749|NCT00432809|Secondary|Cardiovascular Medications - Lipid Lowering Agents|Number of participants taking Lipid lowering agents at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812750|NCT00432809|Secondary|Diabetes Medication - Use of Secretagogue|Number of participants taking Secretagogues at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812751|NCT00432809|Secondary|Diabetes Medication - Use of Incretin Mimetics|Number of participants taking Incretin Mimetics|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2813312|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index||Up to 3 years following randomization.|All randomized participants whose body mass indexes were measured at baseline and at any of the follow-up visits.|||kg/m^2 per year||Standard Error|Least Squares Mean
2812752|NCT00432809|Secondary|Diabetes Medication - Use of Thiazolidinedione|Number of participants using thiazolidinedione at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812753|NCT00432809|Secondary|Diabetes Medication - Use of Biguanides|Number of participants taking Biguanides at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812754|NCT00432809|Secondary|Diabetes Medication - Use of Insulin|Number of participants taking insulin at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812755|NCT00432809|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)|Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/L||Inter-Quartile Range|Median
2812756|NCT00432809|Secondary|Change in Triglycerides|Median percent change in triglycerides at 12 months from baseline measure|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/dL||Inter-Quartile Range|Median
2812757|NCT00432809|Secondary|Change in High-density Lipoprotein (HDL)|Percent change in high-density lipoprotein (HDL) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/dL||Standard Deviation|Mean
2812758|NCT00432809|Secondary|Change in Systolic Blood Pressure (SBP)|Change in Systolic Blood Pressure (SBP) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mm Hg||Standard Deviation|Mean
2812759|NCT00432809|Secondary|Change in Body Mass Index (BMI)|Change in Body Mass Index (BMI) at 12 months, measured in kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg/m2||Standard Deviation|Mean
2812760|NCT00432809|Secondary|Body Mass Index (BMI)|Body Mass Index (BMI) at 12 months measured as kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg/m2||Standard Deviation|Mean
2812761|NCT00432809|Secondary|Change in Body Weight From Baseline|Mean change in body weight from baseline measured in kilograms (kg)|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg||Standard Deviation|Mean
2812762|NCT00432809|Secondary|Body Weight|Body weight in kilograms (kg) measured at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||kg||Standard Deviation|Mean
2812763|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications|The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812764|NCT00432809|Secondary|Glycated Hemoglobin (HbA1c)|Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||percentage points of glycated hemoglobin||Standard Deviation|Mean
2812765|NCT00432809|Secondary|Fasting Plasma Glucose|Fasting Plasma Glucose measured in mg/dL.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||mg/dL||Inter-Quartile Range|Median
2823092|NCT00360334|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2812766|NCT00432809|Secondary|Change in Glycated Hemoglobin (HbA1c)|Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change|1 year - baseline|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||percentage points of glycated hemoglobin||Standard Deviation|Mean
2812767|NCT00432809|Secondary|The Cost-effectiveness of Each Program and the Side Effects and /or Complications.||1, 2, and 5 years.|||||||
2812768|NCT00432809|Secondary|Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.||1, 2, and 5 years|||||||
2812769|NCT00432809|Secondary|Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).||1, 2, and 5 years|||||||
2812770|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.|The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).|1 year|Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.|||participants|||Number
2812771|NCT00432744|Primary|Non-parametric Hotelling T-square Bivariate Analysis of GMGF 88 and OPeds QOL.|This is a multivariate analysis of the first two outcomes: Period 2 minus Period 1 GMFM88 and Peds Quality of Life, analyzed as follows: First, to be in the analysis, subjects must contribute at least one of these endpoints. Second, if the subject became totally disabled during period 1, the difference was defined as + infinity, (highest possible evidence favoring period 2), and if the subject became totally disabled in period 2, the subject was scored as - infinity (highest possible evidence favoring period 1). Period 2 minus period 1 differences were ranked form low to high with missing values scores at the mid-rank. The Hotelling T-square was computed on these ranks and the P-value was obtained from 100,000 rerandomizations as the fraction of rerandomizations with T-sq at least as large as that observed.|end of 12 month minus end of 6 month difference.|Subjects contributes at least one difference (either GMFM or Peds QOL). Thirteen contributed both and one each was missing GMFM or Peds QOL.|||participants|||Number
2812772|NCT00432744|Primary|Pediatric Quality of Life Scale|"The Pediatric Quality of Life Scale is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. Goggle pedsQL and Mapi to browse the copyrighted manual. A link to the instrument is included."|At 6 and 12 Months|7 subjects in each group were evaluable for this endpoint. The two subjects who became disabled are evaluable. One subject did not have period 2 Quality of Life data and is excluded.|||units on a scale||Inter-Quartile Range|Median
2812773|NCT00432744|Primary|McMaster Gross Motor Function (GMFM 88)|The McMaster Gross Motor Function is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. One of the links in this report is to the the GMFM scale and how it is scored. A link to the instrument is included.|Taken at 6 and 12 Months||||units on a scale||Inter-Quartile Range|Median
2812774|NCT00432679|Secondary|Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment|The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.|Up to Week 16|Full analysis set used.|||Percentage of participants|||Number
2812775|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used. Only those participants available at the specified time points were analyzed.|||Nanograms per millilliter||Standard Deviation|Mean
2812776|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Adiponectin|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used. Only those participants available at the specified time points were analyzed.|||Micrograms per millilliter||Standard Deviation|Mean
2812777|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used. Only those participants available at the specified time points were analyzed.|||Percentage of normal beta cells function||Standard Deviation|Mean
2812873|NCT00432458|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|During treatment (up to 5 years)||||participants|||Number
2812778|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used. Only those participants available at the specified time points were analyzed.|||MilliUnit per liter*millimoles per liter||Standard Deviation|Mean
2812779|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used. Only those participants available at the specified time points were analyzed.|||Picomoles per millilliter||Standard Deviation|Mean
2812780|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Fasting Insulin|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used. Only those participants available at the specified time points were analyzed.|||Microunits per millilliter||Standard Deviation|Mean
2812781|NCT00432679|Secondary|Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.|Baseline (Day 0) and Week 16|Full analysis set used.|||Mg per decilliter||Standard Deviation|Mean
2812782|NCT00432679|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group|Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).|Baseline (Day 0) and Week 16|Full analysis set used.|||Percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2812783|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812784|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812785|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812786|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812787|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812788|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812789|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812790|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812791|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812792|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812793|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812794|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812795|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812796|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812797|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change|||Participants|||Number
2812798|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812799|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812800|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812801|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812802|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812803|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812804|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812805|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812806|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812807|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812808|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812809|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812810|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812811|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812812|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812813|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812814|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812815|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812816|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812817|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812818|NCT00432666|Secondary|Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812819|NCT00432666|Secondary|Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812820|NCT00432666|Secondary|Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812821|NCT00432666|Secondary|Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812822|NCT00432666|Secondary|Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812823|NCT00432666|Secondary|Carer's Global Assessment of Efficacy|The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812824|NCT00432666|Secondary|Patient's Global Assessment of Efficacy|The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812825|NCT00432666|Secondary|Investigator's Global Assessment of Efficacy|The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812826|NCT00432666|Other Pre-specified|Onset of Treatment Effect [Classified]|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.~For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at baseline injection of the Main Period up to onset of treatment effect|"These results are a different presentation of the results of the secondary outcome measure Time to Onset of Treatment Effect. For subjects without any treatment effect the time to onset of effect was censored at the last visit."|||Participants|||Number
2823093|NCT00360334|Secondary|Change in Fasting Serum Triglycerides|Change in fasting serum triglycerides from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2812827|NCT00432666|Secondary|Duration of Treatment Effect|The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.|Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator||||Days||95% Confidence Interval|Median
2812828|NCT00432666|Secondary|Time to Waning of Treatment Effect|"Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was no. If the patient answered with yes he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero."|Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect||||Weeks||95% Confidence Interval|Median
2812829|NCT00432666|Secondary|Time to Onset of Treatment Effect|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.~For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect|"Results for placebo patients were not displayed because the upper limit of the confidence interval was not estimable (this can not be entered because a numeric entry is expected). The results of this analysis are therefore given as Onset of Treatment Effect [classified] under Other Pre-specified Outcome."|||Days||95% Confidence Interval|Median
2812830|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812831|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812832|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812833|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812834|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812835|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812836|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812837|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812838|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812839|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812840|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812841|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812842|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812843|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812844|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812845|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812846|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812874|NCT00432458|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the time from randomization to the date at which the patient was removed from (protocol) treatment due to disease progression, unacceptable toxicity, participant refusal or death. The median TTF with 95% CI was estimated using the Kaplan Meier method|time from randomization to treatment failure (up to 5 years)||||months||95% Confidence Interval|Median
2812847|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812848|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812849|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812850|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812851|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812852|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812853|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812854|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects|||Participants|||Number
2812855|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
2812875|NCT00432458|Secondary|Time to Subsequent Treatment|Time to subsequent treatment (TTS) was defined as time from end of active (protocol) treatment to the start of subsequent treatment for participants with progressive disease. The median TTS with 95% CI was estimated using the Kaplan Meier method|time from end of treatment to subsequent treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently across all participants.|||years||95% Confidence Interval|Median
2813313|NCT00429364|Secondary|Annual Rate of Change in Height-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose heights were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
2812856|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
2812857|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
2812858|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
2812859|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
2812860|NCT00432666|Secondary|Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change|||Participants|||Number
2812861|NCT00432666|Primary|Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were not imputed|||Participants|||Number
2812862|NCT00432601|Primary|Knowledge|Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.|Results visit (Time 2 - approximately 7-10 days after Time 1)||||percentage correct on a 12 item scale||Standard Error|Mean
2812863|NCT00432562|Primary|Mean Residence Time (MRTinf)|MRT = (AUMCinf)/(AUCinf)|0-144 hours post-dose||||hours||Standard Deviation|Mean
2812864|NCT00432562|Primary|Last Quantifiable Drug Concentration (Clast)||0-144 hours post-dose||||ng/mL||Standard Deviation|Mean
2812865|NCT00432562|Primary|Time of Last Measurable Concentration (Tlast)||0-144 hours post-dose||||hours||Standard Deviation|Mean
2812866|NCT00432562|Primary|Observed Terminal Elimination Half-Life (t1/2)|t1/2 = [ln(2)/λ z]|0-144 hours post-dose||||hours||Standard Deviation|Mean
2812867|NCT00432562|Primary|Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)|Estimated via linear regression of the time versus log concentration|0-144 hours post-dose||||hr-1||Standard Deviation|Mean
2812868|NCT00432562|Primary|Percentage of AUCinf Based on Extrapolation (AUCextrap)||0-144 hours post-dose||||% of participants||Standard Deviation|Mean
2812869|NCT00432562|Primary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)|AUCinf = AUClast + (Clast/lamda z)|0-144 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
2812870|NCT00432562|Primary|Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)|Determined Using the Linear Trapezoidal Rule|0-144 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
2812871|NCT00432562|Primary|Maximum Observed Plasma Concentration (Cmax)||0-144 hours post-dose||||ng/mL||Standard Deviation|Mean
2812876|NCT00432458|Secondary|Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)|Duration of response (DOR) is defined as the time from first documentation of response (CR, VGPR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method|time from start of response to progression (up to 5 years)|Participants who achieved a confirmed response (CR, VGPR, or PR) as described above were analyzed.|||years||95% Confidence Interval|Median
2812877|NCT00432458|Secondary|Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment|"Response is defined as follows:~CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)~VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|12 months||||participants|||Number
2812878|NCT00432458|Secondary|12-month Progression-free Survival (PFS)|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.|12 months||||participants|||Number
2812879|NCT00432458|Primary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.|randomization to progression (up to 5 years)|Time to disease progression was analyzed on all randomized participants on an intent to treat basis.|||years||95% Confidence Interval|Median
2812880|NCT00432445|Primary|Rate of Local Control in the Globe at 12 Months|Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.|12 months|No analysis performed. Study did not meet anticipated enrollment.||||||
2812881|NCT00432380|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
2812882|NCT00432380|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31-day (Days 0-30) period following any study vaccine dose or placebo|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
2812883|NCT00432380|Secondary|Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes|Presence of RV (vaccine strain or wild-type) in GE stools.|From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
2812884|NCT00432380|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses|The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
2812885|NCT00432380|Secondary|Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea|Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.|During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses|The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.|||Subjects|||Number
2812886|NCT00432380|Secondary|Serum IgA Antibody Concentrations Against Rotavirus|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.|||U/mL||95% Confidence Interval|Geometric Mean
2813314|NCT00429364|Secondary|Annual Rate of Change in Height||Up to 3 years following randomization.|All randomized participants whose heights were measured at baseline and at any of the follow-up visits.|||cm/year||Standard Error|Least Squares Mean
2812887|NCT00432380|Secondary|Number of Seroconverted Subjects for Anti-RV IgA Antibody|Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.|||Subjects|||Number
2812888|NCT00432380|Primary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody|Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.|||Subjects|||Number
2812889|NCT00432341|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'."|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at the time points are included.|||Number of Responses|||Number
2812890|NCT00432341|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
2812891|NCT00432341|Secondary|Patient Comparison of Benefit to Previous Injections at Week 20|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.|||Number of Responses|||Number
2812892|NCT00432341|Secondary|Physician Comparison of Benefit to Previous Injections at Week 20|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.|||Number of Responses|||Number
2812893|NCT00432341|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
2812894|NCT00432341|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
2812895|NCT00432341|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Units on a Scale||Full Range|Median
2812896|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Scores on a Scale||Full Range|Median
2823094|NCT00360334|Secondary|Change in TC to HDL Cholesterol Ratio|Change in TC to HDL cholesterol ratio from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||Ratio||Standard Error|Least Squares Mean
2812897|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4|The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Scores on a Scale||Full Range|Median
2812898|NCT00432341|Primary|Duration of Treatment Benefit|Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].|20 Weeks|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.|||Days||95% Confidence Interval|Median
2812899|NCT00432276|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
2812900|NCT00432276|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μmol/L||Standard Error|Least Squares Mean
2812901|NCT00432276|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
2812902|NCT00432276|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2812903|NCT00432276|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline IDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2812904|NCT00432276|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
2812905|NCT00432276|Secondary|Change From Baseline in VLDL Particles|The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2812906|NCT00432276|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron triglycerides as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812907|NCT00432276|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron particles as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2812931|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812908|NCT00432276|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline NMR triglycerides as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812909|NCT00432276|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
2812910|NCT00432276|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
2812911|NCT00432276|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/ml||Standard Error|Least Squares Mean
2812912|NCT00432276|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in Apolipoprotein C-III was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812913|NCT00432276|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in Apolipoprotein B was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812914|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812915|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812916|NCT00432276|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acids as covariates.|Baseline and Weeks 12, 26, 42, and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
2812917|NCT00432276|Secondary|Change From Baseline in Triglycerides|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812918|NCT00432276|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812919|NCT00432276|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2819079|NCT00390689|Secondary|IRLS Responder|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 6|Full Analysis Set (FAS).|||Percentage of patients|||Number
2812920|NCT00432276|Secondary|Change From Baseline in Total Cholesterol|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812921|NCT00432276|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 4, 8, 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.|Baseline and Weeks 4, 8, 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||kg||Standard Error|Least Squares Mean
2812922|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
2812923|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
2812924|NCT00432276|Secondary|Change From Baseline in C-peptide|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2812925|NCT00432276|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin/insulin ratio as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2812926|NCT00432276|Secondary|Change From Baseline in Fasting Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting insulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μIU/mL||Standard Error|Least Squares Mean
2812927|NCT00432276|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2812928|NCT00432276|Secondary|Percentage of Participants Meeting Hyperglycemic Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 7 days after the first sample and analyzed by the central laboratory:~After more than 2 weeks of treatment but prior to the Week 4 Visit: A single fasting plasma glucose (FPG) ≥275 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: A single FPG ≥250 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: A single FPG ≥225 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% AND ≤0.5% reduction in HbA1c as compared with the baseline HbA1c."|Baseline to Week 52|Full Analysis Set including patients with a postbaseline visit.|||percentage of participants|||Number
2812929|NCT00432276|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|Baseline to Week 52|Full Analysis Set including patients with at least one non-missing fasting plasma glucose result in each treatment group.|||percentage of participants|||Number
2812930|NCT00432276|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline FPG as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug and where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2812932|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812933|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812934|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812935|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812936|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812937|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2812938|NCT00432276|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 34 and 42.|Per-protocol set. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2812939|NCT00432276|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 and Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Weeks 26 and 52.|Per-protocol set included all randomized patients who received at least 1 dose of double-blind study medication and who had no major protocol violations. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2812940|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose.|2 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
2812941|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)|||Participants|||Number
2812942|NCT00432237|Primary|Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
2812943|NCT00432237|Primary|Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
2812944|NCT00432237|Primary|Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
2812945|NCT00432237|Primary|Number of Patients Reporting Pain Relief at 2 Hours Post Dose|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.~Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
2812946|NCT00432237|Secondary|Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose|Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)|||Participants|||Number
2819115|NCT00390416|Secondary|Patients With Measurable Disease the Confirmed Response Rate||up to 2 years||||percentage of participants||95% Confidence Interval|Number
2812947|NCT00432237|Primary|Number of Patients Reporting Pain Freedom at 2 Hours Postdose|"Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.~Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.|||Participants|||Number
2812948|NCT00432172|Secondary|Axillary Node Status at the Time of Surgery|"All the patients underwent lymphadenectomy in the foreseen term from the end of the treatment with neoadjuvant therapy, except for patients who underwent the technique of Sentinel lymph node with negative result before the start of the study treatment.~Clinical lymph node involvement were collected in the CRF. Behind the lymphadenectomy, the rate of patients with affected lymph nodes, regardless of the type of response in the breast. To help find out if the cancer has spread outside the breast, one or more of the lymph nodes in the axilla (axillary lymph nodes) are removed for examination under a microscope. This is an important part of the determination of the stage. When the lymph nodes have cancer cells, there is a greater chance that the cancer cells have spread to other parts of the body. Decisions about treatment will depend on whether there is cancer in the lymph nodes."|Up to 24 weeks|For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis.|||Participants|||Count of Participants
2812949|NCT00432172|Secondary|Breast Conservative Surgery Rate|All patients will undergo surgery within the expected period from the end of treatment with neoadjuvant therapy. The chosen surgical option will be collected in the Case Report Form (CRF) before starting the neoadjuvant treatment, depending on the characteristics Clinics of the patient at that time (conservative surgery or mastectomy). This information will be compared with definitive surgery, to analyze whether neoadjuvant treatment has contributed to increase the rate of conservative surgery.|Up to 24 weeks|For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis.|||Participants|||Count of Participants
2812950|NCT00432172|Secondary|Clinical Response Rate|Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to week 24|For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis.|||Participants|||Count of Participants
2812951|NCT00432172|Primary|Pathological Response for Basal Group 2|This primary outcome only applies for the basal group 2 as per protocol. The pathological response in luminal group 1 was not pre-specified even as a Secondary Outcome. Pathological response was assessed after surgery, according to the Miller & Payne criteria, which stratifies the responses based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in breast and axilla. Grades 1-4 are categorised as a partial pathological response (pPR) and grade 5 was a complete pathological response (cPR).|Up to 24 weeks|For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis.|||Participants|||Count of Participants
2812952|NCT00432159|Secondary|Average Radiographic Disc Height (mm) - Change From Post-op||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||mm||Standard Deviation|Mean
2812953|NCT00432159|Secondary|Global Cervical Range of Motion - Change From Baseline||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||degrees||Standard Deviation|Mean
2812954|NCT00432159|Secondary|Subject Satisfaction|Subject Satisfaction (Would you have this procedure again?)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants|||Number
2812955|NCT00432159|Secondary|Activity|Clinical Assessment of Activity|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants|||Number
2812956|NCT00432159|Secondary|Return to Work|Estimated Proportion of Subjects Returning to Work|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||% of subjects who returned to work|||Number
2812957|NCT00432159|Secondary|Work Status Assessment||24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants|||Number
2812958|NCT00432159|Secondary|SF-36 - Mental Composite Scores (MCS) - Change From Baseline|Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2813015|NCT00431496|Secondary|Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL|Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
2812959|NCT00432159|Secondary|SF-36 - Physical Composite Scores (PCS) - Change From Baseline|Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2812960|NCT00432159|Secondary|Dysphagia Disability Index - Change From Baseline|"Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as always 4, sometimes 2, or never 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia."|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2812961|NCT00432159|Secondary|Average Shoulder Pain VAS - Change From Baseline|Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2812962|NCT00432159|Secondary|Maximum Shoulder Pain VAS - Change From Baseline|Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2812963|NCT00432159|Secondary|Average Arm Pain VAS - Change From Baseline|Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2812964|NCT00432159|Secondary|Maximum Arm Pain VAS - Change From Baseline|Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Deviation|Mean
2812965|NCT00432159|Secondary|Neck Pain VAS Scores - Change From Baseline|Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||Units on a scale||Standard Error|Mean
2812966|NCT00432159|Secondary|NDI - Change From Baseline|Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||NDI Score||Standard Deviation|Mean
2812967|NCT00432159|Secondary|Device-Related SAE Component of Success|no device related serious adverse events|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
2812968|NCT00432159|Secondary|Subsequent Secondary Surgery Component of Success|no subsequent secondary surgical intervention at the index level|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
2823095|NCT00360334|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2812969|NCT00432159|Secondary|Neurological Component of Success|no new clinically significant permanent abnormalities in neurological function|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
2812970|NCT00432159|Secondary|NDI Success|15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).|||participants who are successes|||Number
2812971|NCT00432159|Primary|Overall Success|Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.|24 months|The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).|||participants who are successes|||Number
2812972|NCT00432042|Primary|Post-vaccination Geometric Mean Titres (GMT) to Pertussis|The GMT to pertussis were compared in Arm1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa. Anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (anti-FHA), and anti-pertactin (anti-PRN) were determined using ELISA on solid phase based on sandwich principle.|Day 42|Participants in Arm 1 and Arm 3 who had post-vaccination serology results and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 2 was not planned it was not included.|||GMT (IU/mL)||95% Confidence Interval|Number
2812973|NCT00432042|Primary|Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B|The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: Hepatitis B antibody titre ≥10 IU/mL and Haemophilus Influenzae Type b antibody titre ≥1 ug/mL. Hepatitis B antibody levels were determined using anti-HBs ORTHO ECi Immunodiagnostic Assay. Haemophilus Influenzae Type b antibody (anti-polyribosylribitol phosphate [PRP]) levels were determined with radioimmunoassay (RIA) or with enzyme immunoassay (EIA).|Day 42|Participants in Arm 1 and Arm 3 who had post-vaccination serology results and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 2 was not planned it was not included.|||Percentage of participants||95% Confidence Interval|Number
2812974|NCT00432042|Primary|Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella|The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).|Day 42|Participants in Arm 1 and Arm 2 who were initially seronegative to measles, mumps, rubella, or varicella; had post-vaccination serology results; and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 3 was not planned it was not included.|||Percentage of Participants||95% Confidence Interval|Number
2812975|NCT00431964|Primary|Change in FEV1 From Baseline to End of Treatment at Day 168||change from baseline to day 168|Modified intent to treat (randomized and at least one dose of study drug).|||liters||Standard Deviation|Mean
2812976|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).|||mg||Standard Deviation|Mean
2812977|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||mg||Standard Deviation|Mean
2812978|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).|||ng*hr/mL||Standard Deviation|Mean
2812979|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)|||ng*hr/mL||Standard Deviation|Mean
2812980|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||ng*hr/mL||Standard Deviation|Mean
2812981|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).|||hours||Standard Deviation|Mean
2812982|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)|||hours||Standard Deviation|Mean
2812983|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)|||hours||Standard Deviation|Mean
2812984|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||hours||Standard Deviation|Mean
2812985|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)|||ng/mL||Standard Deviation|Mean
2812986|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)|||ng/mL||Standard Deviation|Mean
2812987|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects|||ng/mL||Standard Deviation|Mean
2812988|NCT00431951|Primary|Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively."|Days 1, 6, 14-16, 21-24, 28-31, and 51-53|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each, and one placebo group with 6 subjects. A total of 7 withdrawals during the entire study were due to inability to follow procedure (4), lost to follow-up (1), requested due to concomitant medication (1), and an adverse event (1)|||Participants|||Number
2812989|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812990|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812991|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812992|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812993|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS):Life Control|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812994|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812995|NCT00431847|Primary|Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance|Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on TOPS scale||Standard Error|Mean
2812996|NCT00431847|Primary|Post Traumatic Stress Disorder (PTSD) Total Severity|Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the PCL scale||Standard Error|Mean
2812997|NCT00431847|Primary|SF-36 Mental Component Summary|The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||t-score||Standard Error|Mean
2812998|NCT00431847|Primary|SF-36 Physical Component Summary|The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||t-score||Standard Error|Mean
2812999|NCT00431847|Primary|Brief Pain Inventory - Treatment Relief|The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief.|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||percentage of pain relief||Standard Error|Mean
2813000|NCT00431847|Primary|Brief Pain Inventory - Pain Interference|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where 0 is pain from combat limb injury does not interfere and 10 is pain from combat limb injury completely interferes with this aspect of daily life."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Brief Pain Inventory Scale||Standard Error|Mean
2813001|NCT00431847|Primary|Brief Pain Inventory - Average Pain|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Brief Pain Inventory Scale||Standard Error|Mean
2813002|NCT00431847|Primary|Brief Pain Inventory - Worst Pain|"The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Brief Pain Inventory Scale||Standard Error|Mean
2813003|NCT00431847|Primary|Neuropathic Pain Scale - Total Score|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The NPS total score is an average of all ten items."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Neuropathic Pain Scale||Standard Error|Mean
2813004|NCT00431847|Primary|Neuropathic Pain Scale - Overall Pain Quality|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Neuropathic Pain Scale||Standard Error|Mean
2813005|NCT00431847|Primary|Neuropathic Pain Scale - Pain Intensity|"The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense pain imaginable."|Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months||||units on the Neuropathic Pain Scale||Standard Error|Mean
2813006|NCT00431834|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge|Entire study population.|||Percentage of subjects||95% Confidence Interval|Number
2813007|NCT00431834|Secondary|Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|6 months|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.|||percentage of subjects|||Number
2813008|NCT00431834|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months||6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.|||percentage of subjects|||Number
2813009|NCT00431834|Primary|Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.|Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.|6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.|||percentage of participants||95% Confidence Interval|Number
2813010|NCT00431626|Primary|Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index|AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)|one year||||units on a scale||Standard Deviation|Mean
2813011|NCT00431496|Secondary|Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL|The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
2813012|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L|The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
2813013|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L|The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
2813014|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)|The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
2815185|NCT00418262|Primary|Pittsburg Side-Effects Scale: Crabby/Irritable|"Crabby/Irritable~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One Subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
2813016|NCT00431496|Primary|Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2|The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet|||Participants|||Number
2813017|NCT00431444|Secondary|Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens|"At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: once a year i.v. infusion, once daily pill, or both are equal."|At 6 month visit|Intention-to-treat (ITT) population.|||Participants|||Number
2813018|NCT00431444|Secondary|Overall Patient Satisfaction Assessed by Satisfaction Questionnaire|"Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely."|Immediately after infusion procedure|Intention-to-treat (ITT) population.|||Participants|||Number
2813019|NCT00431444|Secondary|Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire|"The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely."|Immediately after infusion procedure|Intention-to-treat (ITT) population.|||Participants|||Number
2813020|NCT00431444|Secondary|Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire|"The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely."|Immediately after infusion procedure|Intention-to-treat (ITT) population.|||Participants|||Number
2813021|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months||Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||U/L||Standard Deviation|Mean
2813022|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months||Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||U/L||Standard Deviation|Mean
2813023|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months||Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||U/L||Standard Deviation|Mean
2813024|NCT00431444|Secondary|Change From Baseline in Urine NTx at 4 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||nM BCE/mM Cr||Standard Deviation|Mean
2813025|NCT00431444|Secondary|Change From Baseline in Urine NTx at 2 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||nM BCE/mM Cr||Standard Deviation|Mean
2813026|NCT00431444|Primary|Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)|The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.|||nM BCE/mM Cr||Standard Deviation|Mean
2813027|NCT00431184|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.|at the time of administration of intervention and 5 hours following administration of intervention||||units on a scale||95% Confidence Interval|Mean
2813028|NCT00431184|Primary|Mania Acute Rating Scale (MACS)|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.|On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention||||units on a scale||95% Confidence Interval|Mean
2813029|NCT00431132|Secondary|Transvaginal Ultrasound: Endometrial Thickness|Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.|Week 0, week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.|||mm||Standard Deviation|Mean
2813030|NCT00431132|Primary|Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies|The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.|Week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.|||percentage of participants|||Number
2813031|NCT00431067|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|From first OR to time of progression or death|TS - patients with OR only.|||days||Standard Deviation|Mean
2813032|NCT00431067|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|From first dose of study medication to time when OR measurement was taken.|TS. There were only 4 patients who responded.|||days||95% Confidence Interval|Median
2813033|NCT00431067|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.|From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month|TS (14 patients died)|||days||95% Confidence Interval|Median
2813034|NCT00431067|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month|TS|||days||95% Confidence Interval|Median
2813035|NCT00431067|Primary|Objective Response (OR)|Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .|From first dose of study medication to response measurement, up to 34 month|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
2813036|NCT00431041|Secondary|Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline."|Baseline and 8 weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study|||urgency episodes per day||Standard Deviation|Mean
2813037|NCT00431041|Secondary|Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline."|Baseline and 8 Weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study|||Micturitions per day||Standard Deviation|Mean
2813038|NCT00431041|Primary|The Severity of Dry Mouth Reported as an Adverse Event|"The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).~Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)"|8 weeks|Data represents ITT Population: all randomized subjects|||participants|||Number
2813039|NCT00431041|Primary|The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event|The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit|8 weeks|Data represents ITT Population: all randomized subjects|||participants|||Number
2813040|NCT00430989|Secondary|Hospital Stay (Days)||30 Days Post Op||||Days||Inter-Quartile Range|Median
2813041|NCT00430989|Secondary|Wound Infection||30 Days Post op||||participants|||Number
2813042|NCT00430989|Secondary|Stroke||30 Days Post op||||participants|||Number
2813043|NCT00430989|Secondary|Pulmonary Embolism||30 Days Post op||||participants|||Number
2813044|NCT00430989|Secondary|Cardiac Arrest||30 days||||participants|||Number
2813045|NCT00430989|Secondary|Myocardial Infarction (MI)||30 days post op||||participants|||Number
2813046|NCT00430989|Primary|The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery.||30 days post op||||participants|||Number
2813047|NCT00430950|Secondary|Number of Participants Achieving Blood Pressure Goal.||8 weeks||||participants|||Number
2813048|NCT00430950|Secondary|Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.|Change = Week 16 - Week 8 (baseline).|8 weeks|Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.|||mm Hg||Standard Deviation|Mean
2813049|NCT00430950|Secondary|Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.|4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).|8 weeks||||mm Hg||Standard Deviation|Mean
2813050|NCT00430950|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12|Change = Week 12 - Week 8 (baseline).|4 weeks||||mm Hg||Standard Deviation|Mean
2813051|NCT00430950|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure|"Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.~Change = Week 16 - Week 8 (baseline)."|8 weeks|The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.|||mm Hg||Standard Deviation|Mean
2813052|NCT00430937|Secondary|Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.|"Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.~Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|Population analyzed consisted of patients from the clinically evaluable population who had microbiological assessments.|||Participants|||Number
2813053|NCT00430937|Primary|"Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population."|"Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).~Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for cSSTI as listed in the Protocol, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.|||Participants|||Number
2813054|NCT00430781|Primary|Progression-free Survival (PFS) in Final Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||Weeks||90% Confidence Interval|Median
2813055|NCT00430781|Secondary|Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib|Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.|From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)|Safety Population: all participants who received at least one dose of study drug|||participants|||Number
2813056|NCT00430781|Secondary|Duration of Response|For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population. The median for lapatinib was not reached at the time of data cut-off. No formal analysis of this endpoint was conducted for this group due to a very small number of responding participants.|||weeks||90% Confidence Interval|Mean
2813057|NCT00430781|Secondary|Time to Response|For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||weeks||90% Confidence Interval|Mean
2813058|NCT00430781|Secondary|Response|Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||participants|||Number
2813059|NCT00430781|Secondary|Clinical Benefit Response|Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population|||participants|||Number
2813060|NCT00430781|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)|ITT Population|||Weeks||90% Confidence Interval|Median
2813061|NCT00430781|Primary|Progression-free Survival (PFS) in Interim Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.|From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)|Intent to Treat (ITT) Population: all randomized participants|||Weeks||90% Confidence Interval|Median
2823096|NCT00360334|Secondary|Change in Fasting Serum Total Cholesterol (TC)|Change in TC from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2813062|NCT00430768|Secondary|hAAT Expression in Blood Measured Using M-specific Allele ELISA|4 subjects received prior AAT augmentation therapy; 2 subjects from Group 1 having only washed out for only 28 days complicated the measurement of M-specific levels 2 subjects from group 1 and the other subject did not have an appreciable change in M-specific AAT levels. Thus reporting only Cohorts 2 and 3. After day 90 patients were able to resume AAT protein therapy and thus levels were not collected following commencement of therapy on 201 and 303. 202, Day 365 blood hemolyzed; level not determinable.|Baseline, Days 14, 30, 45, 60, 90, (180, 270, and 365 if not on protein replacement therapy)|AAT Levels of each subject at various time points Baseline and Days following administration. 202 Day 365 blood hemolyzed; not determinable, 201 and 303 went back on AAT protein augmentation therapy after day 90, unable to collect M-specific levels on day 180, 270 and 303.|||nM|||Number
2813063|NCT00430768|Primary|Adverse Events Possibly, Probably or Definitely Related to Study Drug|"Adverse events considered possibly, probably or definitely related to study drug/study drug procedure Criteria to evaluate severity according to Attachment 2 of the Protocol~Mild toxicity, usually transient, requiring no special treatment and generally not interfering with usual daily activities~Moderate toxicity which may be ameliorated by simple therapeutic maneuvers, and impairs usual activities~Severe toxicity which requires therapeutic intervention and interrupts usual activities. Hospitalization may or may not be required~Life-threatening toxicity which requires hospitalization"|During 1 year after study agent administration|subjects in the group reporting the event|||participants|||Number
2813064|NCT00430755|Primary|Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)|Data were extracted from hospital charts by to experienced physicians.; data from the computer histories were extracted by a senior physician, who tabulated comparisons between the 2 sets of records. We used the number of problems reported by Computer Assisted History that were not reported by Physician. Nurses at Robert Bosch Krankenhaus do not take medical histories in regard to allergies or adverse drug reactions. Pharmacists make no entries into charts and have no separate records of drug allergies or history of adverse drug reactions. Data on these issues either are obtained only by physician interview of the patient.|participants were followed for the duration of hospital stay, an average of 8 days|The rest did not end the history tool|||medical problems|||Number
2813065|NCT00430716|Secondary|Change From Baseline in BORG Dyspnoea Score at Week 12|BORG dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||Units on a scale||95% Confidence Interval|Mean
2813066|NCT00430716|Secondary|Change From Baseline in TAPSE Measurement at Week 12|TAPSE was measured as the total displacement of the tricuspid annulus in cm from end diastole to end systole.TAPSE is an indicator of progression of PAH / RV dysfunction.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||cm||95% Confidence Interval|Mean
2813067|NCT00430716|Secondary|Change From Baseline in Pro-BNP at Week 12|Pro- BNP which is a precursor of BNP, is a non-invasive biomarker and an indicator of progression of PAH / RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||pg/mL||95% Confidence Interval|Mean
2813068|NCT00430716|Secondary|Change From Baseline in BNP at Week 12|BNP is a non-invasive biomarker and an indicator of progression of PAH/ RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||pg/mL||95% Confidence Interval|Mean
2813069|NCT00430716|Secondary|Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12|PAH Criteria for WHO Class: Class I (Participants without resulting limitation of physical activity);Class II (Participants with slight limitation of physical activity though comfortable at rest);Class III (Participants with marked limitation of physical activity,though comfortable at rest);Class IV(Participants with inability to carry out any physical activity without symptoms,manifest signs of right heart failure; dyspnoea and/or fatigue may even be present at rest; and discomfort is increased by any physical activity).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
2813070|NCT00430716|Secondary|Time to Clinical Worsening|Clinical worsening was defined as death; or lung transplantation; or hospitalization due to pulmonary hypertension; or initiation of prostacyclin therapy; or initiation of endothelin receptor antagonist therapy.|Baseline through Week 12|Due to very low number of events of clinical worsening reported, the statistical analysis was not conducted and hence data not reported.|||Days||Standard Error|Mean
2813071|NCT00430716|Secondary|Change From Baseline in mPAP at Week 12|mPAP was measured using a pressure transducer positioned at the mid-axillary line.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.|||mmHg||95% Confidence Interval|Mean
2813072|NCT00430716|Primary|Change From Baseline in the Total Distance Walked During 6MWT at Week 12|6 MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Baseline and Week 12|Intention to Treat (ITT population) included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.|||Meters||95% Confidence Interval|Mean
2823097|NCT00360334|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
2813073|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4.|From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
2813074|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN if preRX>ULN, use >1.05*preRX or <LLN. Potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN. Chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRX<LLN, use <0.75*preRX or >ULN if preRX>ULN, use >1.25*preRX or <LLN. Glucose, serum (mg/dL): <65 mg/dL, or >220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX <LLN, use <0.8*preRX or >ULN if preRX>ULN, use >2.0*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX <LLN, use <0.75*preRX. Cholesterol, total (mg/dL): >2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
2813075|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX <LLN, use <0.5*preRX and <100,000/mm^3. Leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8* preRX or >ULN; if preRX>ULN, use >1.2*preRX or <LLN. Neutrophils + Bands (absolute) (*10^3 c/uL): If value <1.0*10^3 or if value >7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
2813076|NCT00430677|Secondary|Number of Participants Achieving Renal Response|Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol.|At Day 365 (end of short-term period) and Day 645|All randomized participants who received treatment.|||participants|||Number
2813077|NCT00430677|Secondary|Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period|Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids|Day 365 to end of long-term extension period|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available.|||Participants|||Number
2813078|NCT00430677|Secondary|Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose.|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
2813079|NCT00430677|Secondary|Mean Change From Baseline in SLICC/ACR Damage Index|SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly.|Day 365 to termination of the long-term extension phase|All randomized participants who received treatment. Treated participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e, Change from baseline greater than or equal to 0). 99, 99 and 100 participants were treated respectively. Refer to outcome measure 11 for baseline values|||Units on a scale||Standard Error|Mean
2813285|NCT00429663|Primary|EQ-5D|EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||units on a scale||Standard Deviation|Mean
2813080|NCT00430677|Secondary|Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis|Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria.|At Day 365 (end of Short-term Period) and Day 645|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||Participants|||Number
2813081|NCT00430677|Secondary|Number of Participants Achieving Complete Response by ACCESS Definition|The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day.|End of short-term period (Day 365) to termination of the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period|||participants|||Number
2813082|NCT00430677|Secondary|Change in Quantitative Immunoglobulin From Baseline During Short-term Period|"A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.~Please refer to Outcome 31 for the respective baseline values"|Day 365|All randomized participants who received treatment. n=Participants with both postbaseline and baseline measurements|||mg/dL||Standard Deviation|Mean
2813083|NCT00430677|Secondary|Baseline Quantitative Immunoglobulins During the Short-term Period|A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing.|Baseline (Day 1)||||mg/dL||Standard Error|Mean
2813084|NCT00430677|Secondary|Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period|A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the 'Ig and/or Junction (Jn) Region' and (2) 'CLTA4 and possibly Ig'. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T.|Day 169, Day 365|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available. n= number of participants who are evaluated|||Participants|||Number
2813085|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Temperature||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||degree celcius||Standard Deviation|Mean
2813086|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Heart Rate||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||beats per minute||Standard Deviation|Mean
2813087|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||mm Hg||Standard Deviation|Mean
2813088|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.|||mmHg||Standard Deviation|Mean
2813089|NCT00430677|Secondary|Participants With Marked Abnormalities Urinalysis During the Short-term Period|PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4).|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
2813090|NCT00430677|Secondary|Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period|"ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.~Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV."|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
2813091|NCT00430677|Secondary|Participants With Marked Laboratory Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
2813092|NCT00430677|Secondary|Participants With Marked Hematology Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements|||Participants|||Number
2813093|NCT00430677|Secondary|Participants With AEs of Special Interest During the Short-term Period|AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.|||Participants|||Number
2813094|NCT00430677|Secondary|Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.|||Participants|||Number
2813095|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population (all randomized and treated subjects). To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Least Squares Mean
2813096|NCT00430677|Secondary|Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2813097|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period|"A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.~The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue."|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
2813098|NCT00430677|Secondary|Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period|A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2813099|NCT00430677|Secondary|Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward (LOCF), participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
2813100|NCT00430677|Secondary|Baseline Mental Component Summary of the Short SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2813101|NCT00430677|Secondary|Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
2813102|NCT00430677|Secondary|Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
2813103|NCT00430677|Secondary|Change in SLICC/ACR Damage Index From Baseline During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value.|Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)|All randomized participants who received treatment and who had postbaseline and baseline measurements showing nonreversible changes (change from baseline >=0) in the SLICC-ACR Damage Index|||Units on a scale||Standard Error|Mean
2813104|NCT00430677|Secondary|Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period|RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5.|Month 12|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants||95% Confidence Interval|Number
2813105|NCT00430677|Other Pre-specified|Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period|"PR is either CRR, Partial Renal Response(PRR),or no Response(NR).~CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR."|Month 12|All randomized participants who received treatment.|||Participants|||Number
2813106|NCT00430677|Secondary|Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)|n=Participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e., Change from Baseline greater than or equal to 0).|||Units on a scale||Standard Deviation|Mean
2813128|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Liver Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI)|Liver Volume has been normalized for percentage of body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||Percent body weight||95% Confidence Interval|Mean
2813129|NCT00430625|Secondary|Change From Baseline to 12 Months in Platelet Counts for Each Treatment Group.|intent to treat (ITT) Population|Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||x10^9/L||95% Confidence Interval|Mean
2813107|NCT00430677|Secondary|Change in Renal Function From Baseline Over Time During Short-term Period|Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point.|||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
2813108|NCT00430677|Secondary|Baseline Renal Function Over Time During Short-term Period|Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|n= Number of participants with measurements for that time point. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.|||milliliters per minute (mL/min)/1.73 m^2||Standard Deviation|Mean
2813109|NCT00430677|Secondary|Number of Months CRR Was Maintained During Short-term Period|Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR.|Day 1 (randomization) to 12 Months|All randomized participants who received participants.|||Months||Full Range|Median
2813110|NCT00430677|Secondary|Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period|CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants||95% Confidence Interval|Number
2813111|NCT00430677|Secondary|Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)|RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation|||Days||95% Confidence Interval|Median
2813112|NCT00430677|Secondary|Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.|||Participants|||Number
2813113|NCT00430677|Secondary|Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 to 12 months|All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders.|||Participants|||Number
2813130|NCT00430625|Secondary|Change From Baseline to 12 Months in Hemoglobin Concentration in 45 U/kg Treatment Group||Week 53|13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||(g/dL)||95% Confidence Interval|Mean
2813131|NCT00430625|Primary|Change From Baseline to 12 Months in Hemoglobin Concentration for the 60 U/kg Treatment Group.|Efficacy endpoint|Week 53|12 patients in the 60 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||g/dL||95% Confidence Interval|Mean
2813303|NCT00429364|Secondary|Event Rate of Death|Percentage of participants who died over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
2813114|NCT00430677|Primary|Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation.|||days|||Number
2813115|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives||Baseline to 12 months|146 Stage 2 hypertensive participants from both the olmesartan and placebo groups|||mm Hg||Standard Deviation|Least Squares Mean
2813116|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives||Baseline to 12 weeks|130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.|||mm Hg||Standard Deviation|Least Squares Mean
2813117|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.||Baseline to 12 weeks|221 non-Black participants from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
2813118|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.||Baseline to week 12|55 Black participants from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
2813119|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.||Baseline to 12 weeks|44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
2813120|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.||Baseline to 12 weeks|232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
2813121|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.|The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|145 female participants from both the olmesartan and placebo groups were analyzed.|||mm Hg||Standard Deviation|Least Squares Mean
2813122|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.|The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|131 male participants|||mm Hg||Standard Error|Least Squares Mean
2813123|NCT00430638|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.|||mm Hg||Standard Error|Least Squares Mean
2813124|NCT00430638|Primary|Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.|||mm Hg||Standard Error|Least Squares Mean
2813125|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Chemokine (C-C Motif) Ligand 18 (CCL18)||Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed.|||Percent|||Number
2813126|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Plasma Chitotriosidase for Each Treatment Group|Percent Change from Baseline to Weeks 53 by Randomized velaglucerase alfa Treatment Group - Subset of intent to treat (ITT) Population who were wild type homozygous for chitotriosidase.|Week 53|2 patients in the 60 U/kg group and 7 patients in the 45 U/kg group who were wild type for the chitotriosidase mutation were analyzed; remaining patients were deficient in chitotriosidase activity.|||Percent|||Number
2813127|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Spleen Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI))|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population. Spleen Volume has been normalized for percent of body weight for each treatment arm. Spleen size relative to body weight = (Spleen volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.|||Percent body weight||95% Confidence Interval|Mean
2813304|NCT00429364|Secondary|Number of Death.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
2813132|NCT00430573|Secondary|Addiction Severity Index (ASI) Drug Use Composite Score|For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity.|Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)|All randomized participants were asked to complete the ASI irrespective of taking study drug. At least one ASI was completed by 8 of the 10 randomized participants. At baseline 8 completed the ASI and the number of participants at each subsequent time point varied.|||units on a scale||Standard Deviation|Mean
2813133|NCT00430573|Primary|Percentage of Positive Toxicology Swabs for Illicit Substances|The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.|Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)|Toxicology swabs were obtained on all 10 randomized participants irrespective of taking study drug. At baseline all 10 had toxicology swabs, at treatment (week 12) 7 had toxicology swabs and at follow-up (week 18) 7 had toxicology swabs.|||percentage of positive toxicology swabs||Standard Deviation|Mean
2813134|NCT00430521|Secondary|Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.|At Month 12 + 7 Days, Month 12 + 21 Days and Month 18|The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813135|NCT00430521|Secondary|Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.|At Month 12 + 7 Days and Month 12 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813136|NCT00430521|Secondary|Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6|Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.|At Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18|This analysis was performed on the ATP Cohort for Immunogenicity (only for M12) and ATP Cohort for Persistence, which included all evaluable subjects for whom immunogenicity data/long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813137|NCT00430521|Secondary|Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Participants|||Count of Participants
2813138|NCT00430521|Secondary|Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6|Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Participants|||Count of Participants
2813139|NCT00430521|Secondary|GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.|At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18|The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Titer||95% Confidence Interval|Geometric Mean
2813140|NCT00430521|Secondary|GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6|GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.|At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18|The analysis was performed on the ATP Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Titers||95% Confidence Interval|Geometric Mean
2813141|NCT00430521|Secondary|GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12|GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.|At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Titers||95% Confidence Interval|Geometric Mean
2813142|NCT00430521|Secondary|GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6|GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.|At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Titers||95% Confidence Interval|Geometric Mean
2813143|NCT00430521|Secondary|Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 0, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||cells/million T-cells||Standard Deviation|Mean
2813144|NCT00430521|Secondary|Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6|Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 0, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18|This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M12, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||cells/million T-cells||Standard Deviation|Mean
2813145|NCT00430521|Secondary|Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M12)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12.|At Month 12 + 7 Days, Month 12 + 21 Days and at Month 18|The analysis was performed on the ATP Cohort for persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813146|NCT00430521|Secondary|Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M12)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12.|At Month 12 + 7 Days and at Month 12 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813147|NCT00430521|Secondary|Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12|Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12.|At Month 12 + 7 Days, Month 12 + 21 Days and Month 18|This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M18), which included all evaluable subjects for whom immunogenicity data/long term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813148|NCT00430521|Secondary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6|A seroprotected (SPR) subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and Month 18|This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Participants|||Count of Participants
2813149|NCT00430521|Secondary|Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6|The seroconversion factor (SCF) was defined as the fold change in serum hemagglutination inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18|This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M6+D7/D21, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813150|NCT00430521|Secondary|Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6|A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18|This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for M6+D7/D21, M18), which included all evaluable subjects for whom immunogenicity data were available and who complied with the criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Participants|||Count of Participants
2813151|NCT00430521|Secondary|GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6|GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.|At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and at Month 18|This analysis was performed on the According-to-Protocol (ATP) Cohort for Persistence, which included all evaluable subjects for whom long term immunogenicity data were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Titers||95% Confidence Interval|Geometric Mean
2813152|NCT00430521|Secondary|Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Participants|||Count of Participants
2813153|NCT00430521|Secondary|Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12|The seroconversion factor (SCF) was defined as the fold change in serum hemagglutination inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.|At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813154|NCT00430521|Secondary|Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005.|At Month 12 + 7 Days, Month 12 + 21 Days and Month 18|This analysis was performed on the According-to-Protocol (ATP) Cohort for Persistence, which included all evaluable subjects for whom ilong term immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813155|NCT00430521|Secondary|Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12|A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.|At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days|This analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Participants|||Count of Participants
2813156|NCT00430521|Secondary|GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12|GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.|At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and at Month 18|This analysis was performed on the ATP Cohort for Immunogenicity and ATP Cohort for Persistence (only for Month 18), which included all evaluable subjects for whom immunogenicity were available and who complied with the inclusion/exclusion criteria defined in the protocol. Day 42 data were available only from subjects who received 3 vaccine doses.|||Titers||95% Confidence Interval|Geometric Mean
2813157|NCT00430521|Primary|Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease|Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M6)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6.|At Month 6 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813158|NCT00430521|Primary|Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease|Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M6)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813305|NCT00429364|Secondary|Event Rate of Aortic-Root Surgery|Percentage of participants who had aortic-root surgery over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
2813159|NCT00430521|Primary|Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease|Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 21 days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813160|NCT00430521|Primary|Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease|Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813161|NCT00430521|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 to Month 18)|This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2813162|NCT00430521|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the entire study period (Day 0 to Month 18)|This analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2813163|NCT00430521|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days)|This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available. Data were collected only for subjects who received the Month 12 vaccine dose.|||Participants|||Count of Participants
2813164|NCT00430521|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days)|This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2813165|NCT00430521|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature above (>) 38 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 days|This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in. The data for Dose 3 were not collected from subjects who did not receive the booster dose, given at either Month 6 or Month 12.|||Participants|||Count of Participants
2813166|NCT00430521|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 days|This analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in. The data for Dose 3 were not collected from subjects who did not receive the booster dose, given at either Month 6 or Month 12.|||Participants|||Count of Participants
2813167|NCT00430521|Primary|Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813168|NCT00430521|Primary|Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813169|NCT00430521|Primary|Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813170|NCT00430521|Primary|Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Day 0|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813171|NCT00430521|Primary|Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813172|NCT00430521|Primary|Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813173|NCT00430521|Primary|Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813174|NCT00430521|Primary|Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813175|NCT00430521|Primary|Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813176|NCT00430521|Primary|Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.|At Month 6|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Fold Increase||95% Confidence Interval|Geometric Mean
2813177|NCT00430521|Primary|Geometric Mean Titers (GMTs) of H5N1 HI Antibodies|GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.|At Month 6 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Titers||95% Confidence Interval|Geometric Mean
2813306|NCT00429364|Secondary|Number of Participants With Aortic-root Surgery.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
2813178|NCT00430521|Primary|Geometric Mean Titers (GMTs) of H5N1 HI Antibodies|GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Titers||95% Confidence Interval|Geometric Mean
2813179|NCT00430521|Primary|Geometric Mean Titers (GMTs) of H5N1 HI Antibodies|GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.|At Month 6|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Titers||95% Confidence Interval|Geometric Mean
2813180|NCT00430521|Primary|Geometric Mean Titers (GMTs) of H5N1 HI Antibodies|GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.|At Day 0|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Titers||95% Confidence Interval|Geometric Mean
2813181|NCT00430521|Primary|Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.|At Month 6 + 21 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813182|NCT00430521|Primary|Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.|At Month 6 + 7 Days|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813183|NCT00430521|Primary|Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.|At Month 6|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813184|NCT00430521|Primary|Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.|At Day 0|This analysis was performed on the According-to-Protocol (ATP) Cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available and who complied with the inclusion/exclusion criteria as defined in the protocol.|||Participants|||Count of Participants
2813185|NCT00430508|Secondary|Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases|||mm Hg||Standard Deviation|Mean
2813186|NCT00430508|Secondary|Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases|||mm Hg||Standard Deviation|Mean
2813187|NCT00430508|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases|||mm Hg||Standard Deviation|Mean
2813188|NCT00430508|Secondary|Number of Patients Achieving Target Blood Pressure at Week 16|Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics|8 weeks|Full Analysis Set-Last Observation Carried Forward|||participants|||Number
2813189|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward|||mm Hg||Standard Deviation|Mean
2813190|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.|||mm Hg||Standard Deviation|Mean
2813191|NCT00430508|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward|||mm Hg||Standard Deviation|Mean
2813192|NCT00430508|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.|||mm Hg||Standard Deviation|Mean
2813249|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit|||percentage of subjects|||Number
2823098|NCT00360334|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
2813193|NCT00430495|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 38|Safety population included all randomized participants who received at least 1 treatment dose and had safety data following their first dose.|||participants|||Number
2813194|NCT00430495|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26|"The EULAR response criteria evaluate change in DAS28 scores represented as good response, moderate response, or no response considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have good or moderate EULAR response if at the time of assessment, their DAS28 score was <=5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2."|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
2813195|NCT00430495|Secondary|Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2813196|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
2813197|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
2813198|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
2813199|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
2813200|NCT00430495|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.|||percentage of participants|||Number
2813201|NCT00430482|Secondary|Addiction Severity Index (ASI) Drug Composite Index|The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use.|Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2|Randomized participants|||units on a scale||Standard Deviation|Mean
2813202|NCT00430482|Primary|Percentage of Positive Toxicology Swabs for Illicit Substances|The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.|Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.|Randomized participants|||percentage of positive toxicology screen||Standard Deviation|Mean
2813203|NCT00430352|Secondary|Percentage of Participants With PR Who Converted to CRu|Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants with PR to most recent treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2813204|NCT00430352|Secondary|Percentage of Participants With Response by Best Response to Study Treatment|Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants who received any study treatment were included in the analysis.|||percentage of participants|||Number
2813205|NCT00430352|Secondary|Time to NLT - Time to Event|TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||months||95% Confidence Interval|Median
2813206|NCT00430352|Secondary|Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event|As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
2813207|NCT00430352|Secondary|Overall Survival (OS) - Time to Event|OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants||95% Confidence Interval|Median
2813208|NCT00430352|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
2813209|NCT00430352|Secondary|Event-Free Survival (EFS) - Time to Event|EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||months||95% Confidence Interval|Median
2813210|NCT00430352|Secondary|Event-Free Survival (EFS) - Percentage of Participants With an Event|The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
2813211|NCT00430352|Secondary|Progression-Free Survival - Time to Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||months||95% Confidence Interval|Median
2813212|NCT00430352|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population|||percentage of participants|||Number
2813213|NCT00430352|Primary|Percentage of Participants With an Adverse Event (AE) - Overall Summary|Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.|24 months|Safety Population: any participant who received at least 1 dose of study treatment.|||percentage of participants|||Number
2813250|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percentage of participants|||Number
2813214|NCT00430300|Other Pre-specified|Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6|Data for this pre-specified endpoint was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813215|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||bpm||Standard Deviation|Mean
2813216|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||milliseconds (msec)||Standard Deviation|Mean
2813217|NCT00430300|Other Pre-specified|Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2813218|NCT00430300|Other Pre-specified|Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6|Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||bpm||Standard Deviation|Mean
2813219|NCT00430300|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2813220|NCT00430300|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)|CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2813221|NCT00430300|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8|The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.|Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter per minute||Standard Deviation|Mean
2813222|NCT00430300|Secondary|Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8|Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||puffs/day||Standard Deviation|Mean
2813251|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percentage of subjects|||Number
2813223|NCT00430300|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8|COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2813224|NCT00430300|Secondary|Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6|BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.|Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2813225|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator IC at Week 6|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813226|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FVC at Week 6|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813227|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV6 at Week 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813228|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV1 at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘N’(number of participants analyzed) signifies participants who were evaluable for this measure.|||liter||Standard Deviation|Mean
2813229|NCT00430300|Secondary|Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6|IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813230|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813231|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.||||||
2813232|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
2813233|NCT00430300|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
2813252|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.|||percentage of subjects|||Number
2813234|NCT00430300|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
2813235|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
2813236|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
2813237|NCT00430300|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 6|Full analysis set (FAS): all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.|||liter||Standard Deviation|Mean
2813238|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.|The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.|||percent change from baseline||Standard Deviation|Mean
2813239|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percent change from baseline||Standard Deviation|Mean
2813240|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.|Baseline and Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percent change from baseline||Standard Deviation|Mean
2813241|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.|Baseline and Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.|||percent change from baseline||Standard Deviation|Mean
2813242|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit|The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.|||percentage of subjects|||Number
2813243|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percentage of subjects|||Number
2813244|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percentage of subjects|||Number
2813245|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.|||percentage of subjects|||Number
2813246|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.|||percentage of subjects|||Number
2813247|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.|||percentage of subjects|||Number
2813248|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.|||percentage of subjects|||Number
2820860|NCT00377832|Secondary|Rate of Determination of Non-reassuring Fetal Status|Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.|Labor--up to 24 hours||||participants|||Number
2813253|NCT00430248|Secondary|Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl|The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.|||percentage of subjects|||Number
2813254|NCT00430248|Primary|Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.|The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.|||percentage of subjects|||Number
2813255|NCT00430183|Secondary|Overall Survival (The Date of Randomization to the Time of Death Due to Prostate Cancer.)||Up to 15 years post-randomization||2030-10-31|10/2030||||
2813256|NCT00430183|Secondary|Disease Progression||Up to 15 years post-randomization||2030-10-31|10/2030||||
2813257|NCT00430183|Secondary|Prostate Cancer-specific-free Survival (The Time From Randomization to the Time of Death Due to Prostate Cancer.)||Up to 15 years post-randomization||2030-10-31|10/2030||||
2813258|NCT00430183|Secondary|Unacceptable Toxicity (Grade 3 or Higher Toxicity)||Up to 15 years post-randomization||2030-10-31|10/2030||||
2813259|NCT00430183|Secondary|Time to Metastatic Disease Progression (The Date of Randomization to Date of Evidence of Systemic Disease on Bone Scan or Cross Sectional Imaging.)||Up to 15 years post-randomization||2030-10-31|10/2030||||
2813260|NCT00430183|Secondary|Time to Clinical Local Recurrence (The Time From Randomization to the First Biopsy-proven Recurrence in the Prostatic Bed or New Mass.)||Up to 15 years post-randomization||2030-10-31|10/2030||||
2813261|NCT00430183|Secondary|5-year bPFS Rate and bPFS||5 years||2020-10-31|10/2020||||
2813262|NCT00430183|Primary|Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years|Proportion of participants surviving 3 years from randomization without biochemical progression or death. bPFS was defined as the time from randomization to the date of the first documented biochemical progression or death. Progression will be defined as having experienced either of the following: a serum PSA level > 0.2 ng/mL that increases on 2 consecutive occasions each of which is at least 3 months apart or death occurs. The time of biochemical failure is measured from the date of randomization to the date of the first PSA level > 0.2 ng/mL.|Up to 3 years||||proportion of patients||95% Confidence Interval|Number
2813263|NCT00430092|Primary|"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."|"Measured on a 0 to 4 scale: 0 is ≤ 1 cell; 1 is 2-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells."|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.|||participants|||Number
2813264|NCT00430027|Primary|Overall Toxicity|The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.|Up to 4 weeks|The study was terminated, study end points were not reached.||||||
2813265|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Relapsed Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)||||days||95% Confidence Interval|Median
2813266|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Plateau Phase Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)||||days||95% Confidence Interval|Median
2813267|NCT00429949|Secondary|Duration of Response|Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.|||cycles|||Number
2813268|NCT00429949|Secondary|Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)|Toxicities were graded using the NCI Common Toxicity Criteria v3.0.|Up to 30 days following end of treatment (median duration of therapy was 51 days)||||participants|||Number
2813269|NCT00429949|Secondary|Time to Response|Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.|||cycles|||Number
2813283|NCT00429663|Primary|EQ Index|EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||units on a scale||Standard Deviation|Mean
2813284|NCT00429663|Primary|Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered were followed.|||units on a scale||Standard Deviation|Mean
2813270|NCT00429949|Primary|Response Rate [Complete Response (CR) and Partial Response (PR)]|"CR requires all of the following:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR.~< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow.~No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).~Disappearance of soft tissue plasmacytoma~PR requires all of the following:~50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks.~-Reduction in 24 hr urinary light chain excretion by either > 90% or to < 200 mg, maintained for a minimum of 6 weeks.~50% reduction in the size of soft tissue plas"|Completion of treatment (median duration of therapy was 51 days)||||participants|||Number
2813271|NCT00429923|Primary|"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."|"Measured on a 0 to 4 scale: 0 is ≤ 1 cell; 1 is 2-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells."|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.|||participants|||Number
2813272|NCT00429793|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry|Study entry up to 2 years||||participants|||Number
2813273|NCT00429793|Other Pre-specified|Reason Off Study Therapy||from study entry until end of study treatment||||participants|||Number
2813274|NCT00429793|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and evaluable patients.|||months||Inter-Quartile Range|Median
2813275|NCT00429793|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years|Eligible and evaluable patients|||months||Inter-Quartile Range|Median
2813276|NCT00429793|Primary|Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)||Up to 5 years|Eligible and evaluable patients.|||Participants|||Count of Participants
2813277|NCT00429793|Primary|Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.|Up to 5 years||||participants|||Number
2813278|NCT00429793|Primary|6 Month Progression-free Survival (PFS)|Number of participants who survived progression-free for more than 6 months.|6 months||||participants|||Number
2813279|NCT00429702|Secondary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy|CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|3 days of following completion of first chemotherapy cycle||||participants|||Number
2813280|NCT00429702|Primary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy|Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy - it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient's symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|during in-patient cycle of chemotherapy, up to 4 days||||participants|||Number
2813281|NCT00429663|Secondary|Valgus of Over 5 Degrees|Valgus is a deformity involving oblique displacement of part of a limb away from the midline.|12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||participants|||Number
2813282|NCT00429663|Primary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.|||units on a scale||Standard Deviation|Mean
2813307|NCT00429364|Secondary|Event Rate of Aortic Dissection.|Percentage of participants who had aortic dissection over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
2813286|NCT00429572|Primary|Number of Participants With Acute or Chronic GVHD And Response to Therapy|"Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from Consensus conference on acute GVHD grading, Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy."|Transplant to 1 year post transplant|As treated: Eighteen received the allogeneic transplantation.|||participants|||Number
2813287|NCT00429572|Primary|Grade II-IV Toxicity|Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).|Up to one year.|As treated: Eighteen received the allogeneic transplantation.|||Participants|||Number
2813288|NCT00429572|Primary|Time to Progressive Disease|Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.|Transplant to Progression.||||Days||Full Range|Median
2813289|NCT00429572|Primary|Overall Survival|Survival duration was calculated from time of transplantation by number of days.|Transplant until death.|As treated: Eighteen received the allogeneic transplantation.|||Days||Full Range|Median
2813290|NCT00429572|Primary|Number of Participants With Tumor Response|Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.|Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.|As treated: Eighteen received the allogeneic transplantation.|||participants|||Number
2813291|NCT00429507|Primary|Time to Progression|Time to progression is measured as the time from study entry to the development of disease progression.|7.5 Years, Study period was March 2007 to November 2014.||||Days||Full Range|Median
2813292|NCT00429494|Primary|Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide|Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.|6 months|Of the 59 patients who underwent HSCT, nine patients refused the second dose of leuprolide and were subsequently taken off study. Six patients died of either disease progression or transplantation-related complications before their ovarian function status was evaluated.|||participants|||Number
2813293|NCT00429416|Secondary|Number of Patients Who Achieve a CD4 Count > 200/Micro-liters|Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant.|Through 60 Days Post Transplant||||participants|||Number
2813294|NCT00429416|Secondary|Rate of Serious Infectious Complications|"Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.~CD4 counts will be measured monthly for the first 3 months after transplant."|Through 3 months post-transplant||||participants|||Number
2813295|NCT00429416|Secondary|Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)|Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit.|Through 24 months post-treatment||||participants|||Number
2813296|NCT00429416|Secondary|Rate of Engraftment of Non-Myeloablative Transplants|Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products.|Through 30 days post-transplant||||participants|||Number
2813297|NCT00429416|Primary|Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality|"Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.~This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included."|Through 100 days post-transplant or death||||participants|||Number
2813298|NCT00429403|Primary|Number of Patients With Response (FSH Level + Vaginal Bleeding)|"Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, response defined as a composite event: both [FSH < 15] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy."|Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year|Analysis was per protocol. Limited analysis due to low recruitment and early termination.|||participants|||Number
2813299|NCT00429364|Secondary|Adverse Drug Reactions Reported During Routine Follow-up Surveillance||From 6 months to 3 years following randomization.|All subjects who had any of the follow-up visits after 6 months post-randomization.|||participants|||Number
2813300|NCT00429364|Secondary|Adverse Drug Reactions Reported at the Baseline Visit||At baseline|All randomized participants.|||participants|||Number
2813301|NCT00429364|Secondary|Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.|Percentage of participants who had aortic dissection, aortic-root surgery or death over a 3-year period following randomization|Up to 3 years following randomization.|All randomized participants who received the treatment|||Percentage of participants||95% Confidence Interval|Number
2813302|NCT00429364|Secondary|Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.||Up to 3 years following randomization.|All randomized participants who received the treatment|||participants|||Number
2813315|NCT00429364|Secondary|Annual Rate of Change in Weight-for-height Z-score||Up to 3 years following randomization.|All randomized participants who were <120 cm in heights and whose weight-for-height z-scores were measured at baseline or at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
2813316|NCT00429364|Secondary|Annual Rate of Change in Weight-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose weight-for-age z-scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
2813317|NCT00429364|Secondary|Annual Rate of Change in Weight||Up to 3 years following randomization.||||kg/year||Standard Error|Least Squares Mean
2813318|NCT00429364|Secondary|Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area||Up to 3 years following randomization.|All randomized participants whose total aortic proximal regurgitant jet area indexes were measured at baseline or at any of the follow-up visits.|||(mm^2/m^2)/year||Standard Error|Least Squares Mean
2813319|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Aortic Annulus||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the aortic annulus were measured at baseline and at any of the follow-up visits.|||cm/year||Standard Error|Least Squares Mean
2813320|NCT00429364|Secondary|Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area||Up to 3 years following randomization.|All randomized participants whose aortic-annulus-diameter z scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
2813321|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Ascending Aorta||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the ascending aorta were measured at baseline and at any of the follow-up visits.|||cm/year||Standard Error|Least Squares Mean
2813322|NCT00429364|Secondary|Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.||Up to 3 years following randomization.|All randomized participants whose ascending-aorta-diameter z scores were measured at baseline and at any of the follow-up visits.|||z-score/year||Standard Error|Least Squares Mean
2813323|NCT00429364|Secondary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension|The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization|Up to 3 years following randomization.||||cm/year||Standard Error|Least Squares Mean
2813324|NCT00429364|Primary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score|The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization|Up to 3 years following randomization.||||z-score/year||Standard Error|Least Squares Mean
2813325|NCT00429299|Secondary|Number of Variations/Somatic Mutation in PI3KCA at Baseline|Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots).|Baseline|ITT Population. Only those participants for which high-quality tumor tissue samples were available were analyzed.|||Variations/Somatic mutations|||Number
2813326|NCT00429299|Secondary|Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment had been exercised in deciding whether reporting was appropriate in other situations.|From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29)|Safety Population: all randomized participants|||Participants|||Number
2813327|NCT00429299|Secondary|Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment|The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal).|At Baseline and Withdrawal (assessed up to Study Week 29)|ITT Population. Only those participants contributing data to the indicated time points were analyzed.|||Percentage of inhibition||Full Range|Median
2813328|NCT00429299|Secondary|Number of Participants With Treatment Failure|Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause.|From randomization up to 29 weeks|ITT Population|||Participants|||Number
2813329|NCT00429299|Secondary|Time to Treatment Failure From the Start of Primary Therapy|Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments.|From randomization up to Study Week 307|ITT Population: all participants who were randomized|||Months||95% Confidence Interval|Median
2813339|NCT00429169|Primary|Go-No go Test|Change in neuropsychological measure of impulsivity. Computer-based task involving induction of a dominant response tendency and testing of the subject's ability to withhold responding to less frequent non-target stimuli.|Measured at Baseline and Week 8|These were the number with analyzable data|||Commission errors||Standard Deviation|Mean
2814022|NCT00424528|Secondary|Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Percentage of participants|||Number
2813330|NCT00429299|Secondary|Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS|The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported.|At Baseline and at surgery (up to Study Week 29)|Efficacy Analysis Population|||Percentage of participants|||Number
2813331|NCT00429299|Secondary|Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography|The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value.|At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27)|Efficacy Analysis Population|||Percentage of participants|||Number
2813332|NCT00429299|Primary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes|Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery.|At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)|Efficacy Analysis Population: all participants in the Intent-to-Treat Population (all participants who were randomized), except for the 2 participants who were excluded because of withdraw of consent and major protocol deviation|||Percentage of participants|||Number
2813333|NCT00429273|Primary|ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)|"The primary clinical efficacy variable for treatment was the ADHD-RS-IV Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ).~The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3).~Scores are obtained by summing each item; The higher the score, the worse the outcome.~Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27"|Measured at baseline Week 4 and Week 8|Every contrast includes estimates of maturation/time trend and the within subject covariance structure based on all participants using full information maximum likelihood estimation.|||units on a scale||Standard Error|Least Squares Mean
2813334|NCT00429182|Secondary|Median Progression Free Survival (PFS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.|Overall study (baseline to disease progression)|Six participants were not evaluable for outcome assessment.|||months||Full Range|Median
2813335|NCT00429182|Primary|Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products|Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.|Baseline to 1 month post AHST|Twenty-one participants provided blood samples for the enumeration of CTCs, before apheresis (baseline) and at one month after AHST.|||participants|||Number
2813336|NCT00429169|Primary|Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.|"Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.~Percent change in contrast of parameter estimates (COPE). COPE is measured during Monetary Incentive Delay Task.~Task conditions are:~Reward=BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment=BOLD signal when subject loses 5 cents vs. loses 0 cents"|Baseline and Week 8.|Major depressive disorder with suicidal thoughts or past suicide attempt.|||percentage of change in COPE||Full Range|Mean
2813337|NCT00429169|Primary|Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment|Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.|Measured at Month 6|These were the number of subjects with analyzable data.|||Events|||Number
2813338|NCT00429169|Primary|Scale for Suicidal Ideation|The clinician-rated Beck Scale for Suicidal Ideation (SSI) (Beck et al 1979)was used weekly for 8 weeks. It has 19 items scaled 0 (least severe) to 2 (most severe) and total score is the sum, ranging 0 to 38 (Beck et al 1979). Items measure frequency, intensity, and attitudes toward suicidal thoughts, feelings of control over them, and suicide plans. Mean score in 90 inpatients hospitalized for suicidal ideation was 9.4±8.4, versus 4.4±5.8 in outpatients as cited in the study by Beck et al, 1979.|Baseline and Week 8|The study was powered for N=50 subjects per group based on naturalistic pilot data from our clinic. An interim data analysis showed an interaction of treatment with baseline suicidal ideation severity on follow-up ideation. After consulting with clinical colleagues, statisticians and the IRB, a decision was made to stop enrollment.|||Points on Scale for Suicidal Ideation||Standard Deviation|Mean
2820861|NCT00377832|Secondary|Rate of Cesarean Delivery|Rate of cesarean delivery|Labor--up to 24 hours||||participants|||Number
2813340|NCT00429143|Secondary|Incidence of Grades III-IV GVHD|"To determine the incidence and severity of GVHD in these patients using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.'~Severity was graded using CTCAE 3.0 (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death)"|6 months|Two patients died prior to expected engraftment. Two patients who rejected were retransplanted and were evaluable for GVHD.|||participants|||Number
2813341|NCT00429143|Secondary|Lymphoid Recovery|To assess the pace of lymphoid recovery in this patient population.|6 months|Two patients did not engraft, two patients died prior to expected day of engraftment|||participants|||Number
2813342|NCT00429143|Secondary|Engraftment Rates|To assess hematopoietic engraftment rates.|6 months|Two patients died prior to expected engraftment day|||participants|||Number
2813343|NCT00429143|Primary|Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD|"To determine the optimal dose of CD3+ donor lymphocytes required for consistent engraftment without the development of grade III/IV GVHD.~Measured as CD3+ donor lymphocytes given as n x 10^8/kg.~n was found to be 2 and was found to be the optimal dose and was the only dose given."|6 months|Two patients died prior to expected day of engraftment|||lymphocytes x 10^8/kg|||Number
2813344|NCT00429143|Primary|Overall Survival of Participants|To determine overall survival at 6 months post-transplant.|6 months|27 Patients undergoing haploidentical transplant at Thomas Jefferson University|||participants|||Number
2813345|NCT00429104|Secondary|Duration of Stable Disease|Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.|6 Years|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.|||weeks||Full Range|Median
2813346|NCT00429104|Primary|Number of Participants With Tumor Response (Stable Disease)|Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.|2 months|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.|||participants|||Number
2813347|NCT00429026|Primary|Survival Rate|Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, & 12 months, then every 4 months for 4 years.|Up to 4 years|Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.||||||
2813348|NCT00428974|Secondary|Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.|A3AR is measured biochemically and the expression level on cells from patients with disease is compared to that from healthy volunteer levels and expressed as a ratio|12 weeks|||||||
2813349|NCT00428974|Secondary|Individual PASI Components Redness, Thickness, and Scale|Each component is scored as 0 (clear, no disease) to 24 (most severe score); lower scores indicate improvement|12 weeks|||||||
2813350|NCT00428974|Secondary|"The Number of Patients Who Achieve a Score of Almost Clear or Clear by Physician's Global Assessment (PGA)"|PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome|12 weeks||||Number of treated patients|||Number
2813351|NCT00428974|Primary|Frequency and Nature of Adverse Events||12 weeks|||||||
2813352|NCT00428974|Primary|Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score|PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement|12 weeks minus baseline||||Scores on a scale||Standard Deviation|Mean
2813353|NCT00428948|Secondary|Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36||Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants taking antihypertensive medication at Baseline with available data were included in the analysis.|||Percentage of participants|||Number
2813354|NCT00428948|Secondary|Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36|A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP [sBP] > 129 mmHg and/or diastolic BP [dBP] > 84 mmHg), (2) hypertensive (sBP > 139 mmHg and/or dBP > 89 mmHg), or (3) requiring antihypertensive therapy.|Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.|||Events/100 follow-up years|||Number
2813355|NCT00428948|Secondary|Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36|Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives [eg, tricyclic antidepressants]) or surgical therapy for pain. In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain. A negative change score indicates less pain. AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.|At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2813356|NCT00428948|Secondary|Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36|For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason. The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.|Baseline to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only non-hypertensive participants with available data were included in the analysis.|||mmHg||Standard Deviation|Mean
2813357|NCT00428948|Secondary|Change in Renal Function Per Year From Week 3 to Month 36|Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine. The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL). The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.|Week 3 to Month 36|Intent-to-treat population: All randomized participants with at least 4 months of follow-up. Only participants with available data were included in the analysis.|||(mg/mL)^-1 per year||Standard Deviation|Mean
2813358|NCT00428948|Secondary|Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36|These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis. Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD. The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have > 139 mmHg systolic blood pressure [BP], > 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline. Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol). Categories included normal (< 2.8 female or < 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (> 28 female or > 20 male.|Baseline to Month 36|Intent-to-treat population: All randomized participants. Only participants with available data were included in the analysis.|||Events/100 follow-up years|||Number
2813359|NCT00428948|Primary|Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36|Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.|Baseline to Month 36|Intent-to-treat population: All randomized participants who had Baseline and post-baseline observations of total kidney volume. Only participants with available data were included in the analysis.|||Percentage change per year||Standard Deviation|Mean
2813360|NCT00428922|Secondary|Changes in CECs as Predictors of PFS and Clinical Benefit|Circulating endothelial cells (CECs) are to be collected day 1 prior to treatment and day 22 prior to treatment. These samples are to be collected at the PI's discretion based upon the availability of the cell processing laboratory, the patients will be informed when consented if the samples will collected or not.|Day 1 and Day 22|CEC data was not collected and available for analysis||||||
2813361|NCT00428922|Secondary|Overall Clinical Benefit Rate (CR+PR+SD)|Defined as best response of CR or PR or stable disease for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|at least 24 weeks||||percent of patients||95% Confidence Interval|Number
2813362|NCT00428922|Secondary|Changes in CTCs as Predictors of PFS and Clinical Benefit|Circulating tumor cells (CTCs) evaluated at baseline (day 1 of treatment) and after 1 treatment cycle (day 22 prior to cycle 2 treatment).|Day 1 and Day 22|Due to sample size, could not perform any statistical analysis to correlate the baseline CTCs with PFS and response rate. Samples only available for 50% of the patients.|||patients with detected CTCs|||Number
2813363|NCT00428922|Primary|Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.|The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.|up to 3 years||||months||95% Confidence Interval|Median
2813364|NCT00428844|Secondary|Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.|||µg•hr/mL||Full Range|Median
2813365|NCT00428844|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.|||µg/mL||Full Range|Median
2813366|NCT00428844|Secondary|Microbiological Response|Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.|||Participants|||Number
2813367|NCT00428844|Secondary|Overall Clinical Outcome|The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.|||Participants|||Number
2813368|NCT00428844|Secondary|Safety - Notable Laboratory Abnormalities|Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.|From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)|Safety Population|||Participants|||Number
2813369|NCT00428844|Primary|Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)|Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.|From the 3rd day of therapy to 1 week post last dose (approximately week 7)|Safety Population|||Participants|||Number
2813370|NCT00428792|Secondary|Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)|"The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: Compared to the patient's condition prior to medication, this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. The investigator compares the patient's overall clinical condition to the 1 week period just prior to the initiation of medication."|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Units on a scale||Standard Deviation|Mean
2813371|NCT00428792|Secondary|Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity|"The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days."|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
2813372|NCT00428792|Secondary|10-Minute Math Test - Problems Solved|"The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to academic productivity. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test."|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Problems solved||Standard Deviation|Mean
2813373|NCT00428792|Secondary|10-Minute Math Test - Problems Attempted|"The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to academic productivity. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test."|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Problems attempted||Standard Deviation|Mean
2813374|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Per protocol (PP) population: All patients in the ITT population who (a) met the inclusion/exclusion criteria liable to affect the efficacy assessment and (b) did not violate the protocol in a manner liable to affect the efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2813375|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
2813376|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
2813670|NCT00427635|Primary|Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring|The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)||||Mean Number of Events||Standard Deviation|Mean
2813377|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
2813378|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating|Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
2813379|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.|||Units on a scale||Standard Deviation|Mean
2813380|NCT00428610|Other Pre-specified|Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment||Study treatment discontinuation up to 30 days post study treatment discontinuation|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2813381|NCT00428610|Secondary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.|First treatment dose up to 43.91 months|All participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2813382|NCT00428610|Secondary|Duration of Stable Disease|Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months|All participants who received at least one dose of the study drug and stable disease or better.|||months||90% Confidence Interval|Median
2813383|NCT00428610|Secondary|Duration of Response|The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to time of measured progressive disease up to 12.68 months|All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR).|||months||90% Confidence Interval|Median
2813384|NCT00428610|Secondary|Overall Survival|Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact.|First treatment to death due to any cause up to 42.91 months|All participants who received at least one dose of the study drug. The numbers of participants censored are 11 (Target Cmax 420 µg/mL group), 6 (Target Cmax 360 µg/mL group) and 14 (Albumin-Tailored Dose group).|||months||90% Confidence Interval|Median
2813385|NCT00428610|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose up to 2 hours postdose in Cycles 1 and 2|All participants who received at least one dose of the study drug and had pharmacokinetics data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2813386|NCT00428610|Secondary|Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)|Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease up to 21.26 months|All participants who received at least one dose of the study drug.|||percentage of participants||90% Confidence Interval|Number
2813387|NCT00428610|Secondary|Progression Free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to measured progressive disease or death due to any cause up to 21.26 months|All participants who received at least 1 dose of the study drug.|||months||90% Confidence Interval|Median
2814023|NCT00424528|Secondary|Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Participants|||Number
2813388|NCT00428610|Primary|Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)|Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease up to 12.68 months|All participants who received at least one dose of the study drug.|||percentage of participants||90% Confidence Interval|Number
2813389|NCT00428597|Secondary|EORTC QLQ-C30 - Pain Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813390|NCT00428597|Secondary|EORTC QLQ-C30 - Nausea and Vomiting Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813391|NCT00428597|Secondary|EORTC QLQ-C30 - Insomnia Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813392|NCT00428597|Secondary|EORTC QLQ-C30 - Financial Difficulties Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813393|NCT00428597|Secondary|EORTC QLQ-C30 - Fatigue Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813394|NCT00428597|Secondary|EORTC QLQ-C30 - Dyspnea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813395|NCT00428597|Secondary|EORTC QLQ-C30 - Diarrhea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813404|NCT00428597|Secondary|Overall Survival (OS)|Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm.|From start of study treatment up to 22 months|ITT. The median OS in months could not be calculated for placebo.|||months||95% Confidence Interval|Median
2814043|NCT00424502|Secondary|Vascular Endothelial Growth Factor (VEGF)|VEGF was measured as picograms per milliliter (pg/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.|||pg/mL||Standard Deviation|Mean
2813396|NCT00428597|Secondary|EORTC QLQ-C30 - Constipation Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813397|NCT00428597|Secondary|EORTC QLQ-C30 - Appetite Loss Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813398|NCT00428597|Secondary|EORTC QLQ-C30 - Social Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813399|NCT00428597|Secondary|EORTC QLQ-C30 - Role Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813400|NCT00428597|Secondary|EORTC QLQ-C30 - Physical Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813401|NCT00428597|Secondary|EORTC QLQ-C30 - Emotional Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813402|NCT00428597|Secondary|EORTC QLQ-C30 - Cognitive Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles with less than 10 subjects are not reported due to lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813403|NCT00428597|Secondary|European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|Patient Reported Outcome (PRO) population=subjects from the ITT population who had completed at least 1 EORTC QLQ-C30 assessment while on treatment. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.|||scores on a scale||Standard Deviation|Mean
2813421|NCT00428441|Secondary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy||3 months|||||||
2813422|NCT00428441|Primary|Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations||3 months|||||||
2813405|NCT00428597|Secondary|Time-to-Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. TTR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for TTR; no placebo subjects reported CR or PR.|||Months||Full Range|Median
2813406|NCT00428597|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for DR; no placebo subjects reported CR or PR.|||Months||Full Range|Median
2813407|NCT00428597|Secondary|Number of Subjects With Objective Response|Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. No placebo subjects had objective response.|||participants|||Number
2813408|NCT00428597|Primary|Progression Free Survival (PFS)|Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.|From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death|Intent-to-treat (ITT) population = all subjects who were randomized.|||Months||95% Confidence Interval|Median
2813409|NCT00428584|Other Pre-specified|Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection||Pre-injection and 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||Millimeters||Full Range|Mean
2813410|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Diameter in Injection Site Redness||1 to 72 hours post injection|3 subjects discontinued and withdrew consent from the Betaseron to Rebif New Formulation Group in the Extension Phase|||Millimeters||Standard Deviation|Mean
2813411|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection||Pain free patients at 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||Participants|||Number
2813412|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection||Pre-injection and 10 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||Millimeters||Full Range|Mean
2813413|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-injection and immediately after injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase|||millimeters||Full Range|Mean
2813414|NCT00428584|Secondary|Diameter of Injection Site Redness|Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection|1-72 hours post injection over the first 12 weeks including the titration period|One subject from the new formulation of rebif group discontinued due to pregnancy|||mm||Standard Deviation|Mean
2813415|NCT00428584|Secondary|Number of Pain Free Patients at 30 Minutes Post-injection|"A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used.~Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population."|30 minutes post injection|One subject from the new formulation of rebif group discontinued due to pregnancy|||Participants|||Number
2813416|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection.|Pre-injection to 10 minutes post-injection|One subject from the new formulation of Rebif group discontinued due to pregnancy|||Millimeters||Full Range|Mean
2813417|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-Injection to Immediately after Injection|One subject from the new formulation of rebif group discontinued due to pregnancy|||millimeters||Full Range|Mean
2813418|NCT00428584|Primary|Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints|Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection|From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron|One subject from the new formulation of rebif group discontinued due to pregnancy therefore, data for the Full Dose Calculation 30min Mean Change was not calculated|||mm||Full Range|Mean
2813419|NCT00428441|Secondary|Mortality||3 months|||||||
2813420|NCT00428441|Secondary|Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy||3 months|||||||
2813424|NCT00428389|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study|The ADCS-ADL scale is composed of 23 items to assess the basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at the end of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
2813425|NCT00428389|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.|The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at End of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
2813426|NCT00428389|Secondary|Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 25 (end of the extension phase) and at the end of study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
2813427|NCT00428389|Secondary|Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25|"The CGIC is an assessment tool used by a skilled clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) very much improved to (4) no change to (7) very much worse."|Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).|||Scores on a scale||Standard Deviation|Mean
2813428|NCT00428389|Secondary|Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study.|From week 5 through the end of extension phase (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.|||Participants|||Number
2813429|NCT00428389|Secondary|Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study.|Baseline through the end of study (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.|||Participants|||Number
2813430|NCT00428389|Primary|Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study|The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.|Baseline through the end of the core phase of the study (Week 5)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.|||Participants|||Number
2813431|NCT00428298|Other Pre-specified|Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks|"The Young Mania Rating Scale has 11 items that rate the subject's subjective experience and clinician observation. Four items are rated 0-8, the remaining are rated 0-4.~The score can range from 0 to 60. A higher score indicates the presence of manic symptoms."|16 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.|||units on a scale||Standard Deviation|Mean
2813432|NCT00428298|Secondary|Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks|The MADRS is a 10 item depression rating scale administered by a research team member. The MADRS is composed of 10 items with a 7 point fixed rating scale (0-6). A higher score indicates the presence of depressive symptoms.|16 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.|||units on a scale||Standard Deviation|Mean
2813671|NCT00427557|Primary|Number of Participants With Engraftment|Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment.|Baseline to 100 days post-engraftment|Analysis per protocol.|||participants|||Number
2813433|NCT00428298|Primary|Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks|"The RBANS is a brief, independently administered measurement of cognitive decline or improvement.~The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS.~The RBANS was administered at baseline and 16 weeks."|16 weeks|Participants who completed screening/first visit Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and study completion/last visit RBANS. Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final RBANS scores. Imputed data was used for those participants.|||percentage of change||95% Confidence Interval|Mean
2813434|NCT00428246|Secondary|Effect of Paricalcitol on Kidney Function||6 weeks|||||||
2813435|NCT00428246|Secondary|Effect of Paricalcitol on Hypertension||6 weeks|||||||
2813436|NCT00428246|Primary|Endothelial Protectant Effects of Paricalcitol||6 weeks|||||||
2813437|NCT00428246|Primary|Anti-Inflammatory Effects of Paricalcitol|change in hsCRP level from baseline to 4 weeks|6 weeks||||micrograms||95% Confidence Interval|Mean
2813438|NCT00428220|Other Pre-specified|Summary of Duration of Clinical Benefit|Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.|From the first day of treatment in parent study until last day of treatment in A6181114 study.|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.|||Weeks||Standard Deviation|Mean
2813439|NCT00428220|Primary|Number of Participants With Treatment-emergent AEs (Treatment-Related)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.|||participants|||Number
2813440|NCT00428220|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.|||participants|||Number
2813441|NCT00428207|Secondary|Frequency of Catheter Change|Recorded by the subjects who will use a checklist to document the reason for the catheter change (routine, insufficient insulin in infusion system, unexplained hyperglycemia, catheter site irritation, suspected occlusion/kinking of catheter, loosening of catheter.|48 to 96 hours|Data collection was incomplete/insufficient and therefore end points could not be evaluated for this assessment.||||||
2813442|NCT00428207|Primary|Glycemic Stability|Glycemic stability will be assessed by MAGE (Mean Amplitude of Glycemic Excursion)(5), M value of Schlichtkrull, standard deviation & coefficient of variation using 7 point finger stick blood glucose measurements performed 48-96 hours after insertion of the pump infusion catheter. Data collected 48 to 72 hours post-catheter insertion will be analyzed separately from the data collected 72 to 96 hours post-catheter insertion. The mean of the measurements taken throughout the study will be used for calculation of the primary endpoint.|48 to 96 hours|"Data collection was incomplete/insufficient and therefore endpoint could not could not be evaluated"||||||
2813443|NCT00428116|Secondary|Morbidity|severe adverse events including death, pneumonia, diarrhea, and other adverse events|18 months post-randomization||||participants|||Number
2813444|NCT00428116|Primary|Growth at 18 Months Post-randomization|Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.|18 months of post-randomization follow-up||||z-score||Inter-Quartile Range|Median
2813445|NCT00428090|Secondary|Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment|Clinical chemistry parameters were identified as of PCC (H, L), if values were out of RR: Alanine aminotransferase (ALT, none-120 [250% upper limit of RR, ULRR]), Albumin (0.75-2), Aspartate aminotransferase (AST,none-105 (3-64y), 137.5 (65+y), >250%ULRR), Alkaline phosphatase (ALP,none-312.5 (20+y), >250%ULRR), blood urea nitrogen (BUN)/Creatinine ratio (none-1.25), BUN (none-11), Chloride (80-115), Calcium (0.75-1.25), Carbon dioxide (CO2, 15-40) content, Creatinine (22, <50% lower limit of RR [LLRR]-155, >125%ULRR), Creatine phosphokinase (CPK, none-1.25), Gamma glutamyl transferase (GGT,none-2.5), Glucose (3.6-7.8), High density lipoprotein (HDL,0.65-none), Lactate dehydrogenase (LDH,none-1.25), Low density lipoprotein (LDL,none-2), Magnesium (0.5-2), Potassium (3-5.5), Phosphorus inorganic (0.5-1.5), Sodium (130-150), Total protein (0.8-1.5), Total cholesterol (none-1.25), Total bilirubin (none-1.95), Triglycerides (none-9). Data for Creatinine clearance not reported.|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Participants|||Number
2813446|NCT00428090|Secondary|Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment|Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC, 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5-AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), neutrophils (0.75-1.5), lymphocytes (0.75-1.5), monocytes (0.75-2), eosinophils (none-2), basophils (none-2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC, 0.8-1.2), red cell distribution width (RDW, 0.8-1.2). Data for mean platelet volume (reference range not established) not reported|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Participants|||Number
2813447|NCT00428090|Secondary|Change From Baseline (W0) in Periodic HbA1c Assessment|HbA1c assessment was performed par. with type 2 diabetes mellitus or HbA1c >=6.5% at Screening only. HbA1c levels were assessed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Percentage||Standard Deviation|Mean
2813448|NCT00428090|Secondary|Change From Baseline (W0) in Hematocrit|Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Percentage of red blood cells in blood||Standard Deviation|Mean
2813449|NCT00428090|Secondary|Change From Baseline (W0) in Hemoglobin|Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Grams per liter (G/L)||Standard Deviation|Mean
2813450|NCT00428090|Secondary|Change From Baseline (W0) in Body Weight|Body weight will be measured at all visits, without shoes and wearing light clothing. The assessments was performed at Baseline, W4, W8, W12, W16, and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Kilogram (Kg)||Standard Deviation|Mean
2813451|NCT00428090|Secondary|Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG HR of Central Cardiologist reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Beats per minute||Standard Deviation|Mean
2813452|NCT00428090|Secondary|Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG parameters includes PR interval, QRS duration, QT - uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval of Central Cardiologist are reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.|Baseline (W0) and up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||milliseconds (MSEC)||Standard Deviation|Mean
2813453|NCT00428090|Secondary|Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).|SBP, DBP and HR of par. were recorded in sitting posture as vital signs, while body weight was measured without shoes and wearing light clothing at each visit. The blood pressure (BP) and HR values were identified as of PCC if the vales were out of the reference range (for SBP, 90 to 140 millimeters of mercury (mmHg), DBP, 50 to 90 mmHg, and HR >100 or <50 beats per minute [bpm]) or meet a change from Baseline criterion. For SBP it was increase from Baseline (high) if increased by more than or equal to (>=) 40 mmHg; decrease from Baseline (low) if decreased by >=30 mmHg. For DBP, increase from Baseline (high) if increased by >=30 mmHg; decrease from Baseline (low) if decreased by >=20 mmHg. For HR, increase from Baseline (high) if increased by >=30 bpm; decrease from Baseline (low) if decreased by >=30 bpm. For weight, increase from Baseline (high) if increased by >=7%; decrease from Baseline (low) if decreased by >=7%. Baseline was defined as value at W0.|Up to W24|Safety Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Participants|||Number
2813454|NCT00428090|Secondary|Number of Participants With Adverse Events Defined by Severity|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE included significant or unexpected worsening or exacerbation of the condition/indication under study, exacerbation of a chronic or intermittent pre-existing condition, new conditions detected or diagnosed, signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concurrent medication. Number of participants with any AE and as per severity were reported. Refer to the general AE/SAE module for a list of AEs and SAEs.|Up to W24|Safety population: This included all par. randomized to treatment who have taken at least one dose of study medication.|||Participants|||Number
2813455|NCT00428090|Secondary|Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.|The blood sample was collected for assessments of HbA1c levels at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Percentage (%)||Standard Error|Least Squares Mean
2813482|NCT00427999|Primary|PSA Response Rate|To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for > 5 ng/ml.|up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||participants|||Number
2813456|NCT00428090|Secondary|Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the par. and takes approximately 5 to 10 minutes to administer. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived|Baseline (W0) and W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813457|NCT00428090|Secondary|Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.|The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer's quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0-30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0-100 (100: worse). The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813458|NCT00428090|Secondary|Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented par. RUD assess both formal and informal resource use of the par. and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 relates to assisting par. with basic activities of daily living and Q2 relates to instrumental activities of daily living. The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Hours||Standard Deviation|Mean
2813459|NCT00428090|Secondary|Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])|The EQ-5D Proxy is a 2 part scale used to assess the quality of life and utility benefit. The data for Part 2 is presented. It is a the visual analogue scale Thermometer which assessed caregiver's impression of par. overall health. The Thermometer has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813460|NCT00428090|Secondary|Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility|The EQ-5D Proxy was a 2 part scale used to assess the quality of life and utility benefit. The data for Part 1 is presented. It is a 5 dimensional Health State Classification. Caregivers were asked to respond as they feel the par. would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to each question were recorded on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813461|NCT00428090|Secondary|Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24|Change from Baseline in short term memory assessment score was assessed from a combined analysis of items 1 (word recall task) and 7 (word recognition task) of ADAS-Cog scale. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). Higher score indicating greater dysfunction. Total score is sum of individual score. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813462|NCT00428090|Secondary|Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24|The DAD, assessed the ability of a par. to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. Endpoint treatment differences which were adjusted to take account of missing data are derived.|Baseline (W0) and up to W24|ITT Population. Only those par. available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813463|NCT00428090|Secondary|Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24|"The NPI assessed behavioral disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The par. caregiver asked about behavior in the par. If Yes, the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score can be calculated by adding all domain scores together; NPI total score: from 0-144 and NPI distress score: from 0-60, all with higher scores indicating more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0."|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles). Endpoint treatment differences which were adjusted to take account of missing data are derived.|||Score on a scale||Standard Error|Least Squares Mean
2813464|NCT00428090|Secondary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means more dysfunction. The scale was based on interviews with the par. and caregiver and was completed by an independent rater. It required separate structured 15-20 minute interviews with the par. and caregiver. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. It was evaluated at Baseline, W8, W16 and W24.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813465|NCT00428090|Secondary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Endpoint treatment differences were adjusted to take account of missing data. It was evaluated at Baseline, W8, W16 and W24.|Baseline (W0) and up to W24|ITT Population. Only those participants available at the specified time points were analyzed (represented as n=x,x,x,x in the category titles).|||Score on a scale||Standard Error|Least Squares Mean
2813466|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in full population.|||Score on a scale||Standard Error|Least Squares Mean
2813467|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4’s: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)|||Score on a scale||Standard Error|Least Squares Mean
2813468|NCT00428090|Primary|Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort|The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3).|||Score on a scale||Standard Error|Least Squares Mean
2813469|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population|||Score on a scale||Standard Error|Least Squares Mean
2813470|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted in all except e4/e4’s: comprised of APOE e4 neg par. (e2/e2, e2/e3, and e3/e3) and APOE e4 heterozygote par. (e2/e4, e3/e4)|||Score on a scale||Standard Error|Least Squares Mean
2813471|NCT00428090|Primary|Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.|Baseline (W0) and W24|ITT Population. Only those par. available at the indicated time points were analyzed. These comparisons were conducted for APOE e4 negative (neg) par. (e2/e2, e2/e3, and e3/e3) cohort|||Score on a scale||Standard Error|Least Squares Mean
2813472|NCT00428077|Secondary|Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.||Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.|||||||
2813473|NCT00428077|Primary|Correlation of Response With Specific HLA Types||12-24 Months|||||||
2813474|NCT00428077|Primary|Immunologic Response Over 1 Year||12 months|||||||
2813475|NCT00428077|Primary|Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions||12-24 Months|||||||
2813476|NCT00428077|Primary|Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts||12-24 Months|||||||
2813477|NCT00428077|Primary|Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.|One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.|Every 3 months for the duration of the 1-year treatment period. .|Per protocol.|||Participants|||Number
2813478|NCT00427999|Secondary|Quality of Life Assessed With EORTC-30|Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|baseline and Final Visit (week 24)|Intent to Treat (ITT) includes the 61 patients treated|||scores on a scale||Standard Deviation|Mean
2813479|NCT00427999|Secondary|Overall Survival Rate|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||days||95% Confidence Interval|Median
2813480|NCT00427999|Secondary|Time to Progression-free Survival|Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||days||95% Confidence Interval|Median
2813481|NCT00427999|Secondary|Time to PSA Response|Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.|||days||95% Confidence Interval|Median
2813483|NCT00427973|Post-Hoc|Discontinued Treatment Due to SAE|Participants that discontinued treatment due to a Serious Adverse Event (SAE)|May 2009 through January 2010||||Participants|||Number
2813484|NCT00427973|Secondary|Overall Survival|Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.|The time from study entry until death from any cause, assessed up to 1 year||||months||95% Confidence Interval|Median
2813485|NCT00427973|Secondary|Response Rate|"Number of patients who achieve either complete or partial response based on RECIST Criteria for target lesions assessed by MRI.~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|Up to 1 year|Patients receiving AZD2171 (cediranib maleate)|||participants with confirmed response|||Number
2813486|NCT00427973|Primary|Progression-free Survival|"Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first.~This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%."|3 months|The number of patients who were progression free at 3 months was determined. 13 of 17 patients (77%) were progression free at 3 months.|||percentage of participants||95% Confidence Interval|Number
2813487|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.|"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
2813488|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in ApoB/ApoA1 Ratio|||Number
2813489|NCT00427960|Secondary|The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in Non-HDL-C/HDL-C Ratio|||Number
2813490|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in TC/HDL-C Ratio|||Number
2813491|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in LDL-C/HDL-C Ratio|||Number
2813492|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in ApoA1|||Number
2813493|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in ApoB|||Number
2813494|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in Non-HDL-C|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in Non-HDL-C|||Number
2813495|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
2813496|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in HDL-C|||Number
2813497|NCT00427960|Secondary|The Percentage Change From Baseline(week6) in TC|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in TC|||Number
2813498|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.|"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
2813499|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
2813500|NCT00427960|Secondary|The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L||6 weeks (Baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percentage of Participants|||Number
2813501|NCT00427960|Primary|Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)|Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).|||Percent Change in LDL-C|||Number
2813502|NCT00427934|Secondary|Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1|PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.|||hr||Full Range|Median
2813503|NCT00427934|Secondary|Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.|||ng/mL||Standard Deviation|Geometric Mean
2813504|NCT00427934|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.|||ng.hr/mL||Standard Deviation|Geometric Mean
2813505|NCT00427934|Secondary|Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.|Withdrawal due to lack of efficacy was collected based on the investigator's judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.|Weeks 1 to 12|FAS|||proportion|||Number
2813506|NCT00427934|Secondary|Number of Subjects With Withdrawal From Study Due to Lack of Efficacy|Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator's judgement.|16 weeks|FAS|||participants|||Number
2813507|NCT00427934|Secondary|Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) [12] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS|||scores on a scale||Standard Error|Least Squares Mean
2813508|NCT00427934|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS|||scores on a scale||Standard Error|Least Squares Mean
2813509|NCT00427934|Secondary|Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline|Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.|Baseline, 16 weeks|FAS|||Participants|||Number
2813510|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.|Baseline, 16 weeks|FAS|||bpm||Standard Deviation|Mean
2813511|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.|Baseline, 16 weeks|FAS|||msec||Standard Deviation|Mean
2813512|NCT00427934|Secondary|Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was > = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was > = 20 mmHg.|Baseline, 16 weeks|FAS|||Participants|||Number
2813513|NCT00427934|Secondary|Change From Baseline in Mean Heart Rate|Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.|Baseline, 16 weeks|FAS|||beats per minute (bpm)||Standard Deviation|Mean
2813514|NCT00427934|Primary|American College of Rheumatology (ACR) 20% Responders at Week 12|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain (Visual Analogue Scale [VAS]), Patient's Global Assessment of Arthritis (VAS), Physician's Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) was defined as an intent-to-treat analysis set that included all subjects randomized to treatment who had taken at least 1 dose of study medication. Missing values were imputed by the method of last observation carried forward (LOCF).|||Participants|||Number
2813515|NCT00427934|Secondary|Change From Baseline in Mean Orthostatic Blood Pressure (BP)|Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop > 20 mmHg, or diastolic BP drop > 10 mmHg and/or drop in systolic BP < 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.|Baseline, 16 weeks|FAS|||mmHg||Standard Deviation|Mean
2813611|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations were presented as micrograms per milliliter (μg/mL).|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2813516|NCT00427934|Secondary|Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12|"DAS28-4 (CRP) was calculated using the following formula:~DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36*natural logarithm(CRP + 1) + 0.014*Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed."|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||mg/L||Standard Error|Least Squares Mean
2813517|NCT00427934|Secondary|Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||mg/L||Standard Error|Least Squares Mean
2813518|NCT00427934|Secondary|Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12|HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS.|||scores on scale||Standard Error|Least Squares Mean
2813519|NCT00427934|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Physician's evaluation based on subject's disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician's Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||scores on scale||Standard Error|Least Squares Mean
2813520|NCT00427934|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|"Subjects answered: Considering all the ways your arthritis affects you, how are you feeling today? Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient's Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed."|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||scores on scale||Standard Error|Least Squares Mean
2813521|NCT00427934|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient's Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||scores on scale||Standard Error|Least Squares Mean
2813522|NCT00427934|Secondary|Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||joint count||Standard Error|Least Squares Mean
2813523|NCT00427934|Secondary|Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||joint count||Standard Error|Least Squares Mean
2813524|NCT00427934|Secondary|ACR 70% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||Participants|||Number
2813525|NCT00427934|Secondary|ACR 50% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.|||Participants|||Number
2813526|NCT00427934|Secondary|ACR 20% Responders at Weeks 1, 2, 4, and 8|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.|Weeks 1, 2, 4, and 8|FAS. Missing values were imputed by the method of LOCF.|||Participants|||Number
2820862|NCT00377832|Secondary|Temperature Difference Before and After Treatment|Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade|90 minutes||||degrees Centigrade||Inter-Quartile Range|Median
2813527|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Units on scale||Standard Deviation|Mean
2813528|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Presenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the ITT population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Units on scale||Standard Deviation|Mean
2813529|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Absenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||units on a scale||Standard Deviation|Mean
2813530|NCT00427921|Secondary|Urinalysis - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks||||number||Standard Deviation|Mean
2813531|NCT00427921|Secondary|Clinical Chemistry - Change From Baseline to Final Visit|Changes from the Group mean at Baseline are compared to the final visit Group mean value|Up to 24 weeks||||number||Standard Deviation|Mean
2813532|NCT00427921|Secondary|Hematology - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks||||number||Standard Deviation|Mean
2813533|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment|"Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity).~Minimal clinically important difference = 7 points. Measure is Mean percent change."|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Units on scale||Standard Deviation|Mean
2813534|NCT00427921|Secondary|50% Improvement in Draining Fistula Count and Fistula Healing|"Decrease in draining fistula is beneficial. 50 percent improvement refers to a reduction in the number of baseline fistula by 50 percent."|Week 12, Week 24, Last Assessment Value (last nonmissing value)|Intent To Treat|||participants|||Number
2813535|NCT00427921|Secondary|Employment Status: Number of Subjects Employed|Summary of employment status of those employed.|Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||participants|||Number
2813536|NCT00427921|Secondary|Overall Health Care Resource Utilization|"From the Overall Health Care Resource Utilization Questionnaire: Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization."|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||number of visits||Standard Deviation|Mean
2813537|NCT00427921|Post-Hoc|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline|Quality of life questionnaire for patients with IBD consisting of 4 domains: systemic, social, emotional, and bowel. This is a 10-item questionnaire, and all items are reported with a 7-point scale (ranging from 1 = poor HRQOL, to 7 = optimum HRQOL). Total SIBDQ score ranges from 10 (quality of life has been negatively affected tremendously by IBD) to 70 (quality of life is barely impacted by IBD). A change greater than 9 points was the minimal clinically important difference (MCID).|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||units on a scale||Standard Deviation|Mean
2813538|NCT00427921|Primary|Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.|Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||Percentage of injections||Standard Deviation|Mean
2813539|NCT00427921|Primary|Total Number of Injections of Adalimumab|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||injections||Standard Deviation|Mean
2813540|NCT00427921|Secondary|Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).|Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.|Week 12, Week 24, and Last Assessment Value (last nonmissing value)||||number of fistulas||Standard Deviation|Mean
2820863|NCT00377832|Primary|Baseline Fetal Heart Rate (FHR) After Treatment||90 minutes||||beats per minute||Standard Deviation|Mean
2813541|NCT00427921|Post-Hoc|Harvey-Bradshaw Index (HBI) Mean Change From Baseline|HBI score (range 0-30) sum subtotal of 5 parameters of subject's CD activity: a)Well being 0=very well-4=terrible b) Abdominal pain 0=none- 3=severe c) Number liquid stools per day d) Abdominal mass 0=none-3=tender e) Complications: 1 point each. Decrease indicates improvement. Absolute decrease of 3 units on scale is clinically important.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|Intent to Treat - subjects who received at least one dose of study drug.|||Units on scale||95% Confidence Interval|Mean
2813542|NCT00427921|Primary|Mean Extent of Exposure - Duration in Days|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.|||days||Standard Deviation|Mean
2813543|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months following vaccination up to Year 5|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813544|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months following vaccination up to Year 4|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813545|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months following vaccination up to Year 3|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813546|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months after vaccination up to Year 2|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813547|NCT00427908|Secondary|Number of Subjects With SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 6 Months after vaccination up to Year 1|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813548|NCT00427908|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813549|NCT00427908|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813550|NCT00427908|Secondary|Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit|Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.|From administration of the vaccine dose until 6 months later|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813551|NCT00427908|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From administration of the vaccine dose until 6 months later|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813552|NCT00427908|Secondary|Number of Subjects With Rash|Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.|From administration of the vaccine dose until 6 months later|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813553|NCT00427908|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813554|NCT00427908|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively.|During the 4-day (Day 0-3) follow-up period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available for the vaccination.|||Participants|||Count of Participants
2813555|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813556|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
2813557|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813558|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
2813559|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813560|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
2813561|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813562|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
2813563|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813564|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.|||Participants|||Count of Participants
2813565|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813566|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
2813567|NCT00427908|Secondary|rSBA Antibody Titers (HPA Laboratory Assay)|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813568|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
2813569|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
2813570|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.|At Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813571|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813572|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
2813573|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813574|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.|||Participants|||Count of Participants
2813575|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Titers||95% Confidence Interval|Geometric Mean
2814044|NCT00424502|Secondary|Anti-cyclic Citrullinated Peptide (Anti-CCP)|Anti-CCP measured as absorbance units per milliliter (AU/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.|||AU/mL||Standard Deviation|Mean
2813576|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Participants|||Count of Participants
2813577|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Participants|||Count of Participants
2813578|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and at Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813579|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813580|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.|||Participants|||Count of Participants
2813581|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813582|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
2813583|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2813584|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
2813585|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
2813586|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2815186|NCT00418262|Primary|Pittsburg Side-Effects Scale: Stomachaches|"Stomachaches~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the Open Label Study|||units on a scale||Standard Deviation|Mean
2813587|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813588|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
2813589|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813590|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.|||Participants|||Count of Participants
2813591|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titer||95% Confidence Interval|Geometric Mean
2813592|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value|The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
2813593|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813594|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
2813595|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as GMCs and expressed in μg/mL.|Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2813596|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
2813597|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||μg/mL||95% Confidence Interval|Geometric Mean
2813598|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
2813599|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titers||95% Confidence Interval|Geometric Mean
2813600|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
2813601|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Titer||95% Confidence Interval|Geometric Mean
2813602|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.|||Participants|||Count of Participants
2813603|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2813604|NCT00427908|Secondary|Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813605|NCT00427908|Secondary|hSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2813606|NCT00427908|Secondary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813607|NCT00427908|Secondary|Anti-TT Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2813608|NCT00427908|Secondary|Number of Subjects With Anti-TT Antibody Concentrations|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813609|NCT00427908|Secondary|Anti-TT Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2813610|NCT00427908|Secondary|Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2824860|NCT00346151|Secondary|Proportion of Participants With Chronic Allograft Nephropathy||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2813612|NCT00427908|Secondary|Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813613|NCT00427908|Secondary|Anti-PS Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2813614|NCT00427908|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813615|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month post vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2813616|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values|The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813617|NCT00427908|Secondary|rSBA Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2813618|NCT00427908|Secondary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) and one month after vaccination [PI(M1)]|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813619|NCT00427908|Primary|Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|One month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Percentage||95% Confidence Interval|Number
2813620|NCT00427908|Primary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|One month after vaccination [PI(M1)]|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813621|NCT00427908|Primary|Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) to vaccination|The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Percentage||95% Confidence Interval|Number
2813622|NCT00427908|Primary|Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.|Prior to (PRE) vaccination|The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813691|NCT00427011|Secondary|Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||hours||Standard Deviation|Mean
2813623|NCT00427908|Primary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response|"Vaccine response was defined as:~for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32~for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination."|One Month after vaccination|The analysis was performed on subjects of 2 years and above from the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
2813624|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
2813625|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
2813626|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
2813627|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants||95% Confidence Interval|Number
2813628|NCT00427895|Secondary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination|Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
2813629|NCT00427895|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.|||Fold Rise||95% Confidence Interval|Geometric Mean
2813644|NCT00427778|Secondary|Score on Question 3 of UDI 6|"Score (0-3) of response to question #3 (stress incontinence specific) of Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Question three asks specifically about Leakage related to activity, coughing, or sneezing, i.e. stress urinary incontinence. Answer is scored from 0-3 (3 most bothersome)."|4 weeks||||units on a scale||Inter-Quartile Range|Median
2815187|NCT00418262|Primary|Pittsburg Side-Effects Scale: Headaches|"Headaches~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from the RCT did not enter the open label study|||units on a scale||Standard Deviation|Mean
2813630|NCT00427895|Secondary|Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||Percentage of participants||95% Confidence Interval|Number
2813631|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group|Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titers||95% Confidence Interval|Geometric Mean
2813632|NCT00427895|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination 1|Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.|||percentage of participants||95% Confidence Interval|Number
2813633|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1|Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titer||95% Confidence Interval|Geometric Mean
2813634|NCT00427804|Primary|Fractional Absorption of Calcium|Fractional absorption of calcium (see citation for complete details)|7 week||||Percentage of absorption|||Number
2813635|NCT00427804|Primary|Intestinal Absorption of Calcium||12 Weeks|||||||
2813636|NCT00427791|Secondary|Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days|Number of participants with incidence of acute graft versus host disease (aGVHD) during first 100 days following transplant.|During the first 100 days following transplant|Analysis was by protocol.|||participants|||Number
2813637|NCT00427791|Primary|Progression-free Survival (PFS)|Time from randomization to first progression or death, whichever comes first, measured in months.|2 Years post transplant or until disease progression or death|Analysis was by protocol. Participants were randomized between Etoposide + Total body irradiation and Etoposide + Total body irradiation + Rituximab using a Bayesian adaptive algorithm.|||Months||Standard Deviation|Median
2813638|NCT00427778|Secondary|Post Void Residual|Post void residual measured by catheter after free flow uroflowmetry|"The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of no treatment UDS."|All uroflow were obtained on arrival of the patient in the UDS suite and prior to instrumentation. patients were asked to arrive with a full bladder, but some did not, explaining the lower number of women with available results.|||ml||Standard Deviation|Mean
2813639|NCT00427778|Secondary|Patient Acceptability (10 cm VAS)|participants completed a 10 cm visual analogue scale at the end of 4 weeks of ring use, rating their pelvic discomfort on a 10 cm scale; 0= none, 10= max.|4 weeks|Women did not fill out this VAS when not wearing the incontinence ring.|||cm||Standard Deviation|Mean
2813640|NCT00427778|Secondary|Impact on I-QOL|The I-QOL (Incontinence-Quality of Life) is a valid and reproducible self-administered measure for assessing quality of life of patients with urinary incontinence. Items are scored on a 4-point Likert response scale (very much, moderately, a little, not at all). Scoring the I-QOL questionnaire involves summing the responses into a single score. The sum score is transformed to a 0-100 scale, with a higher number representing a better quality of life|4 weeks||||units on a scale||Inter-Quartile Range|Median
2813641|NCT00427778|Secondary|Urodynamic Effect of the Incontinence Ring on Flow Rate|Peak flow rate (ml/sec) during uninstrumented uroflow. The 'no treatment' flow rate was obtained during baseline urodynamic studies (UDS) and the 'incontinence ring' flow rate was obtained at the end of the ring period for each participants, while wearing the ring.|baseline and at 4 weeks of ring use.||||ml/sec||Standard Deviation|Mean
2813642|NCT00427778|Secondary|Objective Cure Rate|Number of Participants Without Urinary Stress Incontinence During Provocation testing during urodynamic studies (UDS). Provocations included valsalva and cough, first at 300 ml while lying then standing, followed, if no leakage was seen, to provocations at maximum cystometric capacity while standing.|4 weeks||||Participants|||Count of Participants
2813643|NCT00427778|Secondary|UDI Overall Score|Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Answers are scored from 0-3 (3 most bothersome). An average score is then obtained, ranging from 0-3.|4 weeks||||units on a scale||Inter-Quartile Range|Median
2820935|NCT00377429|Secondary|Number of Participants Who Survived (Post-study at 24 Month Visit)|Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die|2 years|Post study full analysis set|||participants|||Number
2813645|NCT00427778|Primary|Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week|number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.|baseline and 4 weeks|All participants who were randomized and fitted with a ring are included in this intent to treat analysis. Patients for whom a ring could not be successfully fitted were considered failure (<50%) improvement)|||Participants|||Count of Participants
2813646|NCT00427765|Primary|Average Overall Survival Time|Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.|Baseline(transplantation) to disease progression or death for any reason, up to 6 years.|Analysis by protocol|||years||Full Range|Mean
2813647|NCT00427700|Secondary|Serum Levels of Progesterone|The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.|8-10 days after ovulation|Intention to treat.Cases that were lost to follow-up observation, dropped out of the study, failed to collect progesterone on days 22 to 24, and lacked menses after medroxyprogesterone acetate treatment were considered as failures according to the intention-to-treat analysis.|||ng/mL||95% Confidence Interval|Mean
2813648|NCT00427700|Primary|Percentage of Participants With Ovulation Detected by Ultrasound|Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.|cycle day 14-20|intention to treat.|||percentage of participants||95% Confidence Interval|Number
2813649|NCT00427661|Secondary|Incidence of Grade 2-4 Acute GVHD.||100 days||||participants with grade 2-4 AGVHD|||Number
2813650|NCT00427661|Primary|Engraftment at 1 Year Post BMT.|Measurement of total PBMC chimerism|1 year||||participants|||Number
2813651|NCT00427661|Primary|Development of GVHD Within 1 Year of BMT|GVHD is assessed by physical exam, bloodwork and biopsy.|1 year||||participants|||Number
2813652|NCT00427648|Secondary|Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.|This is based on retrograde infusion of sterile water into the bladder using a catheter, the maximum tolerated volume serving to define how much distension a woman can tolerate.|6 weeks|Not all women were able to return for cystometry|||mL||Inter-Quartile Range|Median
2813653|NCT00427648|Secondary|Average Weekly NRS for Frequency at 6 Weeks|NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency|6 weeks|Not all women completed this measure|||score on a 0-10 scale||Inter-Quartile Range|Median
2813654|NCT00427648|Secondary|Global Assessment of Change - Frequency at 6 Weeks|This is patient overall assessment of change in overactive bladder symptoms after treatment. 0% is no change, 100% is total resolution of symptoms|6 weeks||||percent improvement||Inter-Quartile Range|Median
2813655|NCT00427648|Secondary|OAB-q (Symptom Scale) at 6 Weeks|OAB-q SS is a 7 item overactive bladder symptom bother sub scale, ranging from 0-100, higher scores mean worse outcome for bother|6 weeks||||score on a scale||Inter-Quartile Range|Median
2813656|NCT00427648|Secondary|SF-12 Physical at 6 Weeks|SF-12 physical is an abbreviated version of the SF-36 a widely used, general health care quality of life instrument. Scores range from 0-100, and higher scores are better outcomes.|6 weeks||||score on scale||Inter-Quartile Range|Median
2813657|NCT00427648|Secondary|Median Number of Daily Voiding Episodes at 12 Months.||12 months||||voids/day||Inter-Quartile Range|Median
2813658|NCT00427648|Primary|Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.||6 weeks|only 16 participants completed this diary|||voids/day||Inter-Quartile Range|Median
2813659|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH Within 4.0-6.9|Percentage time with pH 4.0-6.9 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)||||Percentage||Standard Deviation|Mean
2813660|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH<4.0|Percentage time with pH<4 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)||||Percentage||Standard Deviation|Mean
2813661|NCT00427635|Secondary|Change From Baseline in Mean Acid Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Seconds||Standard Deviation|Mean
2813662|NCT00427635|Secondary|Change From Baseline in Mean Bolus Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Seconds||Standard Deviation|Mean
2813663|NCT00427635|Secondary|Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
2813664|NCT00427635|Secondary|Change From Baseline in Number of Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
2813665|NCT00427635|Secondary|Change From Baseline in Number of Non Acidic Reflux Episodes|Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
2813666|NCT00427635|Secondary|Change From Baseline in Number of Weakly Acidic Reflux Episodes|Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
2813667|NCT00427635|Secondary|Change From Baseline in Number of Acidic Reflux Episodes|Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
2813668|NCT00427635|Secondary|Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)||||Mean Number of Episodes||Standard Deviation|Mean
2813669|NCT00427635|Secondary|Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux|Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)||||Mean Number of Events||Standard Deviation|Mean
2813672|NCT00427349|Secondary|Objective Response Rate|Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by the total number of analyzable patients. CR is defined as complete disappearance of all tumor lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years||||percentage of participants||90% Confidence Interval|Number
2813673|NCT00427349|Secondary|Overall Survival|Overall survival (OS) is defined as the time from registration until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method , with 95% confidence intervals calculated using Greenwood's formula|assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years|All eligible and treated patients|||months||95% Confidence Interval|Median
2813674|NCT00427349|Primary|Four-month Progression-free Survival Rate|Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.|assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four|The analysis population includes all 44 eligible and treated patients. But 2 patients did not have disease assessment after study entry and are excluded from the analysis.|||percentage of participants||90% Confidence Interval|Number
2813675|NCT00427336|Primary|Number of Patients With Engraftment Response|Engraftment defined as (1) the first of three consecutive days of an Absolute neutrophil count (ANC) >500/mL (b) the first of seven consecutive days of an unsupported platelet count 20,000. Patient needs to survive at least 28 days to be evaluable for engraftment. Chimerism studies need to demonstrate donor-derived hematopoiesis (>90%)|First 100 days post transplant.||||Participants|||Number
2813676|NCT00427297|Secondary|Incidence of Severe Adverse Events (Excluding Mortality)||2 years|15.6 person-years of follow-up overall at time of DSMB closure of study|||event|||Number
2813677|NCT00427297|Primary|Viral Failure|Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load > 400 copies.|2 years|15.6 person years of follow-up overall at time of DSMB closure of study|||Participants|||Count of Participants
2813678|NCT00427297|Primary|Immunologic Failure|Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines).|2 years|15.6 person years of follow-up overall at time of DSMB closure of study|||Participants|||Count of Participants
2813679|NCT00427297|Primary|Incidence of Mortality|Death during follow-up|2 years|Analysis was conducted at DSMB termination of study with 15.6 person-years of follow-up time in the cohort overall; 8.5 person-years in NVP-containing and 7.1 person-years in NVP-sparing arm.|||Participants|||Count of Participants
2813680|NCT00427193|Other Pre-specified|Change in Fat Mass|Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.|baseline, 12 months||||Kg||Standard Deviation|Mean
2813681|NCT00427193|Other Pre-specified|Change in Fat Mass|Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.|change 0 to 24 months||||kg||Standard Deviation|Mean
2813682|NCT00427193|Secondary|Change in Tumor Necrosis Factor-α (TNF-α), Baseline to 12 Months||change baseline to 12 months||||pg/mL||Standard Deviation|Mean
2813683|NCT00427193|Primary|Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition||Baseline, 24 months||||Kcal/day||Standard Deviation|Mean
2813684|NCT00427193|Primary|Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition, Baseline to 12 Months||Baseline, 12 months||||Kcal/day||Standard Deviation|Mean
2813685|NCT00427193|Primary|Change in Core Temperature, Baseline to 24 Months||Baseline to 24 months||||degrees Celsius||Standard Deviation|Mean
2813686|NCT00427193|Primary|Change in Core Body Temperature, Baseline to 12 Months||Baseline to 12 months||||degrees Celsius||Standard Deviation|Mean
2813687|NCT00427037|Primary|25-hydroxyvitamin D|25-hydroxyvitamin D measured in serum by ELISA|3 months||||ng/mL||95% Confidence Interval|Mean
2813688|NCT00427037|Secondary|Bone Turnover Marker-CTX|Blood levels of C-telopeptide|12 weeks||||pg/mL||95% Confidence Interval|Geometric Mean
2813689|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|The UPDRS is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||scores on a scale||Standard Deviation|Mean
2813690|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study|Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||scores on a scale||Standard Deviation|Mean
2813692|NCT00427011|Primary|Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.|||hours||Standard Deviation|Mean
2813693|NCT00426855|Primary|Optimal Bendamustine Dosage for Further Studies||Three weeks after treatment termination||||mg/m^2|||Number
2813694|NCT00426842|Primary|Systolic Blood Pressure|brachial artery systolic blood pressure (mmHg)|The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.||||mmHg||Standard Deviation|Mean
2813695|NCT00426764|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study.|From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days.|Safety Population: all participants who received at least 1 dose of romidepsin.|||Participants|||Count of Participants
2813696|NCT00426764|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score.|From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.|Safety Population: all participants who received at least 1 dose of romidepsin.|||participants|||Number
2813697|NCT00426764|Secondary|Time to Disease Progression|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.|Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.|||days||95% Confidence Interval|Median
2813698|NCT00426764|Secondary|Duration of Complete Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.|Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.|||days||95% Confidence Interval|Median
2813699|NCT00426764|Secondary|Duration of Objective Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.|Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.|||days||95% Confidence Interval|Median
2813700|NCT00426764|Secondary|Percentage of Participants With Objective Disease Response|Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response (PR) according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses & extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.|Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.|||percentage of participants||95% Confidence Interval|Number
2813715|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI|Mean sum STR was calculated as the difference between baseline (ECGI) and ECG II: the mean of the sum of ST elevation resolution from all ECG leads associated with infarct location. ST resolution was expressed as a percentage from baseline.|Baseline (ECG I) and immediately prior to PCI (ECG II)|ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.|||percent change||Standard Deviation|Mean
2813701|NCT00426764|Primary|Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee|Complete Response (CR): >75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed >75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by >75% in their SPD.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.|Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.|||percentage of participants||95% Confidence Interval|Number
2813702|NCT00426751|Secondary|Mean Duration of Stay in the Ward|Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.|until 6 months after index-MI|ITT Population|||days||Standard Deviation|Mean
2813703|NCT00426751|Secondary|Number of Participants With Minor Bleedings (TIMI Classification)|The number of participants with minor bleedings (according to TIMI classification: clinically overt bleeding [e.g., gross haematuria or haematemesis) associated with a drop in haematocrit of ≥ 9% or a drop in haemoglobin of ≥ 3 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
2813704|NCT00426751|Secondary|Number of Participants With Major Bleedings (TIMI Classification)|Number of participants with major bleedings (according to TIMI classification: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
2813705|NCT00426751|Secondary|Number of Participants With Heart Failure Until 6 Months After PCI|The number of participants with heart failure within 6 month after PCI was measured.|until 6 Months (Day 180) after index-MI|Safety Population|||participants|||Number
2813706|NCT00426751|Secondary|Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI|The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.|until 6 Month (Day 180) after index-MI|Safety Population|||participants|||Number
2813707|NCT00426751|Secondary|Number of Participants Who Experienced Stroke or Major Bleeding Complications|Number of participants who experienced stroke (hemorrhagic, non-hemorrhagic) or major bleedings (TIMI class: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL).|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
2813708|NCT00426751|Secondary|Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)|The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population|||participants|||Number
2813709|NCT00426751|Secondary|Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)|The number of participants who died, experienced re-MI, or experienced UTVR (necessity of re-PCI of the target vessel or coronary artery bypass graft [CABG] because of recurrent ischaemic angina within 30 days after PCI) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population: All participants who received at least one dose of study medication.|||participants|||Number
2813710|NCT00426751|Secondary|Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI|The number of participants with the indicated myocardial blush grade (TMPG), used to assess the myocardial reperfusion in the infarcted myocardium following PCI (as assessed by the core angiography laboratory), was measured. Blush grades: 0 = failure of dye to enter the microvasculature; 1 = dye slowly enters but fails to exit the microvasculature; 2 = delayed entry and exit of dye from the microvasculature; 3: normal entry and exit of dye from the microvasculature. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.|after PCI|ITT Population|||participants|||Number
2813711|NCT00426751|Secondary|Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI|cTIMI frame counts (number of cineframes needed for dye to reach standardized distal landmarks in a coronary vessel; objective index of coronary blood flow) following PCI, as assessed by core angiography lab.|after PCI|ITT Population. Participants with un-evaluable angiographies were excluded from analysis.|||number of frame counts||Standard Deviation|Mean
2813712|NCT00426751|Secondary|Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI|The number of participants with TIMI grade 3 (complete perfusion) patency of the infarcted vessels following PCI, as assessed by core angiography lab, was measured.|after PCI|ITT Population|||participants|||Number
2813713|NCT00426751|Secondary|Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI|Number of participants with the respective patency of the infarcted vessels was evaluated by TIMI (Thrombolysis In Myocardial Infarction) flow grades (Grade 0 = No perfusion, Grade 1 = Penetration with minimal perfusion, Grade 2 = Partial perfusion, Grade 3 = Complete perfusion), as assessed by core angiography lab.|immediately before PCI|ITT Population|||participants|||Number
2813714|NCT00426751|Secondary|Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI|Max STE is measured similarly to single-lead STR, but was not compared with the ST deviation on the baseline ECG I. It was the existing ST deviation on the single ECG lead of maximum ST deviation present at 60 minutes after the PCI (ECG III).|60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.|||millimeters (mm)||Standard Deviation|Mean
2813716|NCT00426751|Secondary|Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1 -V4), whichever lead showed the largest deviation either at baseline or at follow-up, respectively. STR was expressed as a percentage from baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.|||percent change||Standard Deviation|Mean
2813717|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Some participants were un-evaluable with regard to the primary endpoint and were counted as failures. These participants were excluded from this analysis.|||percent change||Standard Deviation|Mean
2813718|NCT00426751|Secondary|Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference (as a percentage) between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1- V4), whichever lead showed the largest deviation either at baseline or at ECG III, respectively (Complete: ≥ 70%; Partial: ≥ 30% and <70%).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population|||participants|||Number
2813719|NCT00426751|Secondary|Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline (Complete: ≥ 70% resolution; Partial: ≥ 30% and < 70% resolution; None: < 30% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population|||participants|||Number
2813720|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.|||participants|||Number
2813721|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.|||participants|||Number
2813722|NCT00426660|Secondary|Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)|Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for genotypic changes in the V3 Loop of glycoprotein 120 (gp 120)."|||participants|||Number
2813723|NCT00426660|Secondary|Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau|Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for maraviroc susceptibility."|||participants|||Number
2813724|NCT00426660|Secondary|Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure|Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Screening up to Week 144|Safety analysis set; N = participants with virologic failure (VF). Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = participants with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF.|||percentage of participants|||Number
2813725|NCT00426660|Secondary|Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure|Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 144|Safety analysis set; N = number of participants with virologic failure.|||percentage of participants|||Number
2813726|NCT00426660|Secondary|Median Time to Virologic Failure|Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Day 1 up to Week 144|Safety analysis set. N = number of participants with virologic failure. For the calculation of the time to virologic failure, any visits with no data were excluded. Participants who were not virologic failures were censored at the last available observation.|||days||Inter-Quartile Range|Median
2813727|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count Percent|Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of lymphocytes||Standard Deviation|Mean
2813728|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||cells/uL||Standard Deviation|Mean
2813729|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count Percent|Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of lymphocytes||Standard Deviation|Mean
2813730|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||cells/uL||Standard Deviation|Mean
2813731|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL|Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
2813732|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL|Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
2813733|NCT00426660|Secondary|Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA|Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
2813734|NCT00426660|Secondary|Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)|"Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.~Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference."|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.|||percentage of participants|||Number
2813735|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status|Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.|||percentage of participants|||Number
2813736|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age|Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.|||percentage of participants|||Number
2813737|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race|Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.|||percentage of participants|||Number
2813738|NCT00426660|Primary|Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender|Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.|||percentage of participants|||Number
2813739|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study by time on therapy were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.||||||
2813740|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline/nadir CD4 cell counts were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.||||||
2813741|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline viral load were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.||||||
2813742|NCT00426660|Primary|Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses|Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.|Baseline up to Week 144|Safety analysis set.|||percentage of participants|||Number
2813743|NCT00426660|Primary|Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.|||percentage of participants|||Number
2813744|NCT00426660|Primary|Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.|||percentage of participants|||Number
2813745|NCT00426660|Primary|Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)|AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.|Baseline up to Week 144|Safety analysis set: all participants who were randomized and received at least one dose of study medication.|||percentage of participants|||Number
2813746|NCT00426556|Secondary|Phase II: Overall Survival (OS)|Overall survival (OS) is defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months until death|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Months||95% Confidence Interval|Median
2813747|NCT00426556|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Months||95% Confidence Interval|Median
2813748|NCT00426556|Secondary|Phase I: Best Overall Response (BOR)|BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR or SD >= 24 weeks).CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for partial disease (PD). PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Percentage of Participants|||Number
2813749|NCT00426556|Primary|Phase II: Overall Response Rate|The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.|||Percentage of Participants|||Number
2813750|NCT00426361|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).|||Participants|||Count of Participants
2814499|NCT00422383|Secondary|Percentage of Participants With Complement Component 4 (C4) Protein Level ≤ LLN|The LLN of C4 protein was defined as < 0.1 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||percentage of participants|||Number
2813751|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).|||Participants|||Count of Participants
2813752|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day period (Day 0-29) following vaccination||||Participants|||Count of Participants
2813753|NCT00426361|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria."|During the 7-day period (Day 0-6) following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2813754|NCT00426361|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)|"Booster response to PT, FHA and PRN were defined as:~For initially seronegative subjects [pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)]: antibody titers at least 4 times the cut-off,~For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,~For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
2813755|NCT00426361|Secondary|Number of Subjects With Booster Response to Diphtheria and Tetanus|"Booster responses to diphtheria and tetanus were defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and~For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
2813756|NCT00426361|Secondary|Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||titer||95% Confidence Interval|Geometric Mean
2813757|NCT00426361|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
2813758|NCT00426361|Secondary|Titers of Anti-diphtheria and Anti-tetanus Antibodies|Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.|One month after vaccination with Boostrix-Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||IU/mL||95% Confidence Interval|Geometric Mean
2813759|NCT00426361|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month post Cervarix Dose 3 (Month 7/8)]|Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2813760|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Dose 1|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on subjects from the Cervarix and Cervarix + Boostrix Polio groups with available results for the defined antibody.|||Participants|||Count of Participants
2813761|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Cervarix Dose 3 (Month 7/8)|Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.|||Participants|||Count of Participants
2813828|NCT00425672|Secondary|Incidence of Interleukin-2 (IL-2) and IL-2 Receptor (IL-2R) Expression in Tumor Samples by Immunohistochemical (IHC) Analysis|The incidence of IL-2 expression and its receptor complex, IL-2R in tumor samples will be evaluated by IHC analysis. Tumor sections will be interpreted as either positive or negative.|21 days after cycle 6||||Participants|||Count of Participants
2813762|NCT00426361|Primary|Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3|Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio and with available results for the defined antigen.|||Participants|||Count of Participants
2813763|NCT00426361|Primary|Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2813764|NCT00426361|Primary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.|||Participants|||Count of Participants
2813765|NCT00426283|Secondary|To Investigate the Change in Subject Symptoms and Response to FP.||3 months|||||||
2813766|NCT00426283|Secondary|To Investigate Subject Compliance and Response to FP.||3 months|||||||
2813767|NCT00426283|Secondary|To Investigate the Relationship Between Gene Expression, Blood Levels (CBC, Serum IL-5, Eotaxin-3 and IgE) Eosinophil Phenotype, (Via Flow Cytometry and Functional Responses) and Response to FP.||3 months|||||||
2813768|NCT00426283|Secondary|To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.||3 months|||||||
2813769|NCT00426283|Secondary|To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.||3 months|||||||
2813770|NCT00426283|Primary|The Percentage of Participants Who Attained Remission.|Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.|3 months||||percentage of participants||95% Confidence Interval|Number
2813771|NCT00426270|Secondary|Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7|The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention).|Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.|||Percentage of participants|||Number
2813772|NCT00426270|Secondary|Duration of the Clinical Response|The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.|||Days||Standard Deviation|Mean
2813773|NCT00426270|Secondary|Maximum Platelet Count|Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.|||*10^9/L||Standard Deviation|Mean
2813774|NCT00426270|Secondary|Time to Achieve a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.|||Days||Standard Deviation|Mean
2813775|NCT00426270|Primary|Percentage of Participants With a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.|||Percentage of participants|||Number
2813776|NCT00426231|Secondary|Self-reported Medication Adherence|Only individuals with 6-month follow-up data were included in this analysis|6 months||||participants|||Number
2813777|NCT00426231|Primary|Achievement of LDL-cholesterol Goals|Achieving the goal of an LDL cholesterol level of < 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.|6 months||||participants|||Number
2813778|NCT00426153|Secondary|Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 12 months||||units on a scale||Standard Deviation|Mean
2813855|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.||From Baseline to Month 3, 6, and 12|Safety population|||mmol/L||Standard Deviation|Mean
2813779|NCT00426153|Secondary|Percent Change in Glomerular Filtration Rate (GFR)|Percent change from baseline in renal function/GFR, measured by clearance of iothalamate with monitoring of bladder emptying using ultrasound|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.|||percent change||Standard Deviation|Mean
2813780|NCT00426153|Secondary|Percent Change in Renal Volume|Percent change from baseline in renal volume, measured in milliliters by MRI or CT scans|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.|||percent change||Standard Deviation|Mean
2813781|NCT00426153|Primary|Percent Change in Liver Volume|Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans|Baseline, 12 months||||percent change||Standard Deviation|Mean
2813782|NCT00426127|Secondary|Safety and Effect of Chemo Regimen on D-Dimer Measured by Drawing D-Dimer Levels Every Cycle||3 weeks|There was no analysis done||||||
2813783|NCT00426127|Secondary|Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle|Incidence of elevated D-Dimer was defined as >.50 as drawn every cycle. Incidence of elevated D-Dimer was tested to determine safety and efficacy of the treatment regimen on patients with advanced pancreatic cancer.|3 weeks|2 patients received at least one cycle of treatment and underwent blood draws testing D-Dimer levels|||Blood draw|||Number
2813784|NCT00426127|Primary|Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy||9 weeks|One participant underwent 3 cycles of therapy and progressed as assessed by CT.|||Participants|||Count of Participants
2813785|NCT00425945|Secondary|AST/SGOT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||u/L||Standard Deviation|Mean
2813786|NCT00425945|Secondary|ALT/SGPT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||u/L||Standard Deviation|Mean
2813787|NCT00425945|Secondary|Hemoglobin A1c|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.|||mg/dL||Standard Deviation|Mean
2813788|NCT00425945|Secondary|Fasting Insulin|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||mg/dL||Standard Deviation|Mean
2813789|NCT00425945|Secondary|Fasting Blood Glucose|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||mg/dL||Standard Deviation|Mean
2813790|NCT00425945|Secondary|Weight|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||lb||Standard Deviation|Mean
2813791|NCT00425945|Secondary|Body Mass Index|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||kg/m^2||Standard Deviation|Mean
2813792|NCT00425945|Secondary|C-reactive Protein|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.|||nmol/L||Standard Deviation|Mean
2813793|NCT00425945|Secondary|Lipoprotein A|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)|three months||||nmol/L||Standard Deviation|Mean
2813794|NCT00425945|Secondary|HDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||nm||Standard Deviation|Mean
2813795|NCT00425945|Secondary|LDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||nm||Standard Deviation|Mean
2813796|NCT00425945|Secondary|Triglycerides|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months||||mg/dL||Standard Deviation|Mean
2813797|NCT00425945|Secondary|HDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||mg/dL||Standard Deviation|Mean
2813798|NCT00425945|Secondary|LDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||mg/dL||Standard Deviation|Mean
2813799|NCT00425945|Secondary|Total Cholesterol|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months||||mg/dL||Standard Deviation|Mean
2813800|NCT00425945|Primary|Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.|Mean at Week 12 observation minus mean at Baseline observation.|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.|||mm Hg||95% Confidence Interval|Mean
2813801|NCT00425854|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)|Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.|day 29||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2813802|NCT00425854|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).|baseline till end of treatment||||participants|||Number
2813803|NCT00425854|Secondary|Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)|LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.|Baseline and last assessment|TS|||Participants|||Number
2813804|NCT00425854|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death.|From randomisation to end of follow-up.|TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A.|||days||95% Confidence Interval|Median
2813805|NCT00425854|Primary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort B as CB was primary endpoint only for Cohort A.|||Participants|||Number
2813806|NCT00425854|Primary|Objective Response (OR)|OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B.|||Participants with OR|||Number
2813807|NCT00425854|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS|||days||95% Confidence Interval|Median
2813808|NCT00425854|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median duration of OR was not calcuable as there was no OR observed.||||||
2813809|NCT00425854|Secondary|Time to OR|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median time to OR was not calcuable as there was no OR observed.||||||
2813810|NCT00425854|Secondary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort A as CB was secondary endpoint only for Cohort B.|||Participants with CB|||Number
2813811|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||cells/microliter||Inter-Quartile Range|Median
2813812|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 6 Months||6 months|Data for the remaining 10 patients was not fully collected or analyzed for publication|||cells/microliter||Inter-Quartile Range|Median
2813813|NCT00425802|Secondary|Response to Treatment||2 years|Data for the remaining 10 patients was not fully collected or analyzed for publication|||Participants|||Count of Participants
2813814|NCT00425802|Secondary|Immune Reconstruction/CD4+ Count at 3 Months||3 months|Data for the remaining 10 patients was not fully collected or analyzed for publication|||cells/microliters||Inter-Quartile Range|Median
2813815|NCT00425802|Secondary|Incidence of Chronic GVHD at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||percentage of participants||95% Confidence Interval|Number
2813816|NCT00425802|Secondary|Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days||100 days|Data for the remaining 10 patients was not fully collected or analyzed for publication|||percentage of patients||95% Confidence Interval|Number
2813817|NCT00425802|Secondary|Time to Platelet Engraftment||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||days||Full Range|Median
2813818|NCT00425802|Secondary|Time to Neutrophil Engraftment||2 years|Data for the remaining 10 patients was not fully collected or analyzed for publication|||days||Full Range|Median
2813819|NCT00425802|Primary|Overall Survival at 1 Year||1 year|Data for the remaining 10 patients was not fully collected or analyzed for publication|||percentage of participants||95% Confidence Interval|Number
2813820|NCT00425750|Secondary|Progression-free Survival|Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)|7.55 months (average duration, on study to off study)||||Month||95% Confidence Interval|Median
2813821|NCT00425750|Secondary|Overall Survival|Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)|7.55 months (average duration, on study to off study)||||Month||95% Confidence Interval|Median
2813822|NCT00425750|Primary|Patient Response to Treatment|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|7.55 months (average duration, on study to off study)||||participants|||Number
2813823|NCT00425698|Secondary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|6 month after transplantation|||||||
2813824|NCT00425698|Primary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|42 days after transplantation||||ml/min||Standard Deviation|Mean
2813825|NCT00425672|Secondary|Anti-tumor Effects of ONTAK Determined by Tumor Response and Progression|Anti-tumor effects of ONTAK will be determined by evaluating tumor response and progression per RECIST. An objective response to ONTAK will be defined as achieving a CR or PR. Analysis of the data will include determination of complete (CR) and partial response (PR) rates, as well as stable (SD) and progressive disease (PD).|21 days after cycle 6||||Participants|||Count of Participants
2813826|NCT00425672|Secondary|Presence of Endogenous Tumor-specific Immunity|Evaluate the effect of ONTAK on endogenous tumor specific immunity|21 days after cycle 6||||Participants|||Count of Participants
2813827|NCT00425672|Secondary|Presence of Circulating sIL-2R in the Peripheral Blood|Evaluate levels of circulating sIL-2R (pg/ml) in the peripheral blood assessed before and after ONTAK therapy. Changes from baseline will be tabulated.|21 days after cycle 6|4/14 patients had peripheral blood available before and after ONTAK treatment.|||pg/ml||Full Range|Median
2813856|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.|Blood chemistry - total cholesterol (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population|||mmol/L||Standard Deviation|Mean
2813829|NCT00425672|Primary|Efficacy of ONTAK in Depleting T-regulatory Cells as a Decrease in Peripheral Blood Tregs Using Flow Cytometry|The efficacy of ONTAK in depleting Tregs will be defined as a decrease in peripheral blood Tregs by 25% of each individual subject's baseline. All subjects will undergo blood draws at baseline and post ONTAK infusions at designated time points. Tregs from the peripheral blood will be quantitated using flow cytometry.|21 days after cycle 6|14 patients equals patients that had repeat blood draws taken but did not complete the treatment except for 4 patients who completed the study|||Participants|||Count of Participants
2813830|NCT00425672|Primary|Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0|Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.|7 Days after last dose of ONTAK||||Participants|||Count of Participants
2813831|NCT00425607|Primary|Proportion of Participants With Successful Rate of Weight Gain|"Activity was assessed by determining the change in rate of weight gain over two years from baseline (determined pre-therapy for each patient).~Primary outcome success was predefined as a 50% increase over pre-therapy in estimated annual rate of weight gain, or change from pre-therapy weight loss to statistically significant on-study weight gain."|Assessed at weeks 16, 32, 52, 68, 84 and 104|Results are reported for the 25 patients with classic HGPS who completed at least 2y of therapy. One additional patient with a prior history of strokes died of a stroke after 5 mo on study and is not included in the analysis. Two additional patients had nonclassic mutations and are not included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2813832|NCT00425503|Primary|The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.|Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.|Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgery||||Events|||Number
2813833|NCT00425477|Secondary|Biological Activity as Measured by in Vivo Induction of Terminal Differentiation of Myeloid Progenitors and in Vivo Changes in Detectable Chromosomal Abnormalities||Baseline and 6, 12, 24, and 36 weeks|Due to the limited number of clinical responders, this research assay was not done.||||||
2813834|NCT00425477|Secondary|Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements|ANC count at baseline and after two cycles were measured and compared. Due to the limited number of clinical responders, the changes in transfusion requirements were not measured.|Baseline and after two cycles||||neutrophils/mm^3||Standard Error|Mean
2813835|NCT00425477|Primary|Clinical Response (Complete and Partial)|Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria.|assessed after 2 cycles, up to 2 years||||Participants|||Count of Participants
2813836|NCT00425438|Primary|Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event|CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
2813837|NCT00425438|Secondary|Time to Treatment Failure|Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
2813838|NCT00425438|Secondary|Percentage of Participants Terminating Treatment||Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
2813839|NCT00425438|Secondary|Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)|GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
2813840|NCT00425438|Secondary|Percentage of Participants With Treatment Response Event by End of Treatment|Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
2813841|NCT00425438|Secondary|Complete Response|The median time, in months, to CR was defined as the time from randomization to CR event.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.||||||
2813842|NCT00425386|Secondary|Maximum Percent Change in Tumor Measurement|The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD.|Baseline through end of study, up to 7 years||||percent change in size||Full Range|Mean
2813843|NCT00425386|Secondary|Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease||From the start of treatment until the criteria for response is met.||||percentage of participants|||Number
2813844|NCT00425386|Secondary|Median Time to Progression|The Kaplan-Meier method will be used to estimate the median time to progression.|For the duration of the study, up to 7 years||||months||95% Confidence Interval|Median
2813845|NCT00425386|Secondary|To Determine the Safety of Sunitinib in Combination With Erlotinib||For the duration of the study, up to 7 years||||participants|||Number
2813846|NCT00425386|Primary|Progression-free Survival at 8 Months|Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).|8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney||||percentage of participants||95% Confidence Interval|Number
2813847|NCT00425386|Primary|Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.|The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.|Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years||||milligrams|||Number
2813848|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||Percentage of patients|||Number
2813849|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||Percentage of patients|||Number
2813850|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||Percentage of patients|||Number
2813851|NCT00425373|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
2813852|NCT00425373|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
2813853|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).|Blood chemistry - C-reactive Protein (CRP) (mg/L)|From Baseline to Month 3, 6, and 12|Safety population|||mg/L||Standard Deviation|Mean
2813854|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.||From Baseline to Month 1, 3, 6, 9, and 12|Safety population|||mmol/L||Standard Deviation|Mean
2813863|NCT00425308|Primary|Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: completed patients|||(mL/min)||Standard Error|Least Squares Mean
2813864|NCT00425308|Primary|Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: all patients with a baseline value|||(mL/min)||Standard Error|Least Squares Mean
2813865|NCT00425269|Secondary|Intake of Fish, Post Test||post-test, after completion of all six group sessions||||portions/week||Inter-Quartile Range|Mean
2813866|NCT00425269|Secondary|Intake of Poultry, Post-test||post-test, after completion of all six group sessions||||portions/week||Inter-Quartile Range|Mean
2813867|NCT00425269|Secondary|Intake of Red Meat, Post-test||post-test, after completion of all six group sessions||||portions/week||Inter-Quartile Range|Mean
2813868|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Post-test||post-test, after completion of all six group sessions||||dl/week||Inter-Quartile Range|Mean
2813869|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Post-test||post-test, after completion of all six group sessions||||grams per day||Inter-Quartile Range|Mean
2813870|NCT00425269|Secondary|Body Mass Index, Post-test||post-test, after completion of all six group sessions||||kg/m^2||95% Confidence Interval|Mean
2813871|NCT00425269|Secondary|Waist Circumference||post-test, after completion of all six group sessions||||cm||95% Confidence Interval|Mean
2813872|NCT00425269|Secondary|Diastolic Blood Pressure, Post-test||post-test, after completion of all six group sessions||||mmHg||95% Confidence Interval|Mean
2813873|NCT00425269|Secondary|Systolic Blood Pressure, Post-test||post-test, after completion of all six group sessions||||mmHg||95% Confidence Interval|Mean
2813874|NCT00425269|Secondary|Triglycerides, Post-test||post-test, after completion of all six group sessions||||mmol/L||95% Confidence Interval|Mean
2813875|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Post-test||post-test, after completion of all six group sessions||||mmol/L||95% Confidence Interval|Mean
2813876|NCT00425269|Secondary|Insulin, 2-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
2813877|NCT00425269|Secondary|Insulin, 0-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
2813878|NCT00425269|Secondary|C-peptid, 2-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
2813879|NCT00425269|Secondary|C-peptid, 0-h, Post-test||post-test, after completion of all six group sessions||||pmol/L||95% Confidence Interval|Mean
2813880|NCT00425269|Secondary|HbA1C, Post-test||post-test, after completion of all six group sessions||||percent of Hb||95% Confidence Interval|Mean
2813881|NCT00425269|Primary|Plasma Glucose, 2-h, Post-test||post-test||||mmol/L||95% Confidence Interval|Mean
2813882|NCT00425269|Primary|The Fasting Plasma Glucose, Post-test||post-test||||mmol/L||95% Confidence Interval|Mean
2813883|NCT00425269|Secondary|Intake of Fish, Baseline||baseline||||portions/week||Inter-Quartile Range|Mean
2813884|NCT00425269|Secondary|Intake of Poultry, Baseline||baseline||||portions/week||Inter-Quartile Range|Mean
2813885|NCT00425269|Secondary|Intake of Red Meat, Baseline||baseline||||portions/week||Inter-Quartile Range|Mean
2813886|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Baseline||baseline||||dL/week||Inter-Quartile Range|Mean
2813887|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Baseline||baseline||||gram per day||Inter-Quartile Range|Mean
2813888|NCT00425269|Secondary|Body Mass Index, Baseline||baseline||||kg/m^2||95% Confidence Interval|Mean
2813889|NCT00425269|Secondary|Waist Circumference, Baseline||baseline||||cm||95% Confidence Interval|Mean
2813890|NCT00425269|Secondary|Diastolic Blood Pressure, Baseline||baseline||||mmHg||95% Confidence Interval|Mean
2813891|NCT00425269|Secondary|Systolic Blood Pressure, Baseline||baseline||||mmHg||95% Confidence Interval|Mean
2813892|NCT00425269|Secondary|Triglycerides, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
2813893|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
2813894|NCT00425269|Secondary|Insulin, 2-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
2813895|NCT00425269|Secondary|Insulin, 0-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
2813896|NCT00425269|Secondary|C-peptid, 2-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
2813897|NCT00425269|Secondary|C-peptide, 0-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
2813898|NCT00425269|Secondary|HbA1c, Baseline||baseline||||percent of Hb||95% Confidence Interval|Mean
2813899|NCT00425269|Primary|Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
2813900|NCT00425269|Primary|The Fasting Plasma Glucose Value, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
2813901|NCT00425113|Secondary|Time to Sputum Culture Conversion to Negative on Solid Medium||2 months||||days||95% Confidence Interval|Median
2813912|NCT00425100|Secondary|Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)|Improvement: positive score change; No improvement: zero or negative score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||participants|||Number
2814500|NCT00422383|Secondary|Change From BL in Activated Complement Component 3a (C3a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
2813902|NCT00425113|Primary|Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT).|Lesions were defined as nodules (<2 mm, 2-<4 mm, and 4-10 mm), consolidations, collapse, cavities, fibrosis, bronchial thickening, tree-in-bud opacities, and ground glass opacities. Each CT was divided into six zones (upper, middle, and lower zones of the right and left lungs) and independently scored for the above lesions by three separate radiologists blinded to treatment arm. A fourth radiologist adjudicated any scores that were widely discrepant among the initial three radiologists. The HRCT score was determined by visually estimating the extent of the above lesions in each lung zone as follows: 0=0% involvement; 1= 1-25% involvement; 2=26-50% involvement; 3=51-75% involvement; and 4=76-100% involvement. A composite score for each lesion was calculated by adding the score for each specific abnormality in the 6 lung zones and dividing by 6, with the change in composite score measured at 2 and 6 months compared to baseline. Composite sums of all 10 composite scores are reported.|6 months.||||reader score||Standard Error|Mean
2813903|NCT00425100|Secondary|Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)|Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.|Week 12|Subjects in safety set included subjects who took at least one dose of study drug. Missing responses to the Treatment Satisfaction Question at Week 12 were imputed as not satisfied for calculating the most conservative treatment satisfaction.|||participants|||Number
2813904|NCT00425100|Secondary|Sum Rating on the Urinary Sensation Scale|"The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 no feeling of urgency to 5 unable to hold; leak urine."|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813905|NCT00425100|Secondary|"Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)"|Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.|Week 12|Population included subjects in FAS (described above) with non-missing values on OAB-S at Week 12, referred to in table below as All Subjects. Summary was presented for All Subjects and 2 subgroups, based on categorization for treatment satisfaction question used in primary endpoint assessing satisfaction.|||scores on a scale||Standard Deviation|Mean
2813906|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale|Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813907|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813908|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813909|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813910|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813911|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813937|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||10^9 cells/L||Standard Deviation|Mean
2813913|NCT00425100|Secondary|Urgency Perception Scale (UPS)|"UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet [without leaking])."|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813914|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)|Improvement: negative score change; No change: score change=0; Deterioration: positive score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||participants|||Number
2813915|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score|"The PPBC score ranges from 1 no problems at all to 6 many severe problems."|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813916|NCT00425100|Secondary|Mean Rating on the Urinary Sensation Scale|"The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 no feeling of urgency to 5 unable to hold; leak urine."|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2813917|NCT00425100|Secondary|Severe Urgency Episodes Per 24 Hours|Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with baseline severe urgency episodes >0 and non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of episodes||Standard Deviation|Mean
2813918|NCT00425100|Secondary|Nocturnal Micturitions Per 24 Hours|"Nocturnal micturitions (synonymous with the term nighttime micturitions) were those recorded in the bedtime section of the bladder diary."|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of nocturnal micturitions||Standard Deviation|Mean
2813919|NCT00425100|Primary|Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment|Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.|Week 12|Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||participants|||Number
2813920|NCT00425100|Primary|Mean Number of Urgency Episodes Per 24 Hours|The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)).The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of episodes||Standard Deviation|Mean
2813921|NCT00425100|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment. Restricted to subjects with UUI at baseline >0.|||number of episodes||Standard Deviation|Mean
2813922|NCT00425100|Primary|Mean Number of Micturition Episodes Per 24 Hours|The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.|||number of episodes||Standard Deviation|Mean
2813923|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||participants|||Number
2813938|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 1||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||10^9 cells per liter (cells/L)||Standard Deviation|Mean
2813924|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
2813925|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
2813926|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
2813927|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
2813928|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
2813929|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
2813930|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 1|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
2813931|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3|Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.|||participants|||Number
2813932|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1|Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.|||participants|||Number
2813933|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813934|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 1||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813935|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies participants evaluated for this measure at the specified time point for each arm."|||log-10 IU/mL||Standard Deviation|Mean
2813936|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 1) included all randomized participants who received at least 1 dose of test article in Stage 1. LOCF method was used to impute missing values.'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.n signifies participants evaluated for this measure at the specified time point for each arm."|||log-10 IU/mL||Standard Deviation|Mean
2813939|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813940|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813941|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 2/3|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813942|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 1|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813943|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 2/3|The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813944|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 1|The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.||||||
2813945|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||percentage of participant|||Number
2813946|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||percentage of participants|||Number
2813947|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of =< 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2813948|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||units on a scale||Standard Deviation|Mean
2813949|NCT00425061|Secondary|Change From Baseline in Airway Hyper-reactivity at Day 28 and 112|Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.|Baseline, Day 28, 112|mITT population included all randomized participants who received at least 1 dose administration of the test article. LOCF method was used to impute missing values. 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||milligram per milliliter (mg/mL)||Standard Deviation|Geometric Mean
2813950|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.|||liter||Standard Deviation|Mean
2813968|NCT00424749|Primary|Participants With Remission of Renal Disease Activity at 3 Months|Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)|3 months after beginning of remission induction regimen||||participants|||Number
2813951|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.|||liter||Standard Deviation|Mean
2813952|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3|The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies those participants who were evaluated for this measure at the specified time point for each arm."|||L/min||Standard Deviation|Mean
2813953|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1|The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. Last observation carried forward (LOCF) method was used to impute missing values.|||liter per minute (L/min)||Standard Deviation|Mean
2813954|NCT00424840|Primary|Number of Subjects Who Require Dose Delay/Reduction in Dose of Bortezomibin the First Cycle|Dose limiting toxicity at Level 1,2 and 3: Number of subjects who required dose delay/reduction in dose of bortezomib in the first cycle of treatment. DLT defined by any of the following during first cycle: (1) GR4 neutropenia or thrombocytopenia, (2) Greater than GR3 non-hematological toxicity except alopecia or inadequately treated nausea or vomiting or (3) neurosensory toxicity of GR2 with pain or any neurotoxicity greater than GR2.|up to 21 days for each dosing cycle||||participants|||Number
2813955|NCT00424827|Secondary|Toxicity Associated With This Regimen.||1-Year||||participants|||Number
2813956|NCT00424827|Secondary|Overall Survival||Up to 2 years||||months||95% Confidence Interval|Median
2813957|NCT00424827|Secondary|Resection Rate||1-Year|4 subjects underwent resection after treatment|||participants|||Number
2813958|NCT00424827|Secondary|Biomarker Response to Chemoradiation Therapy|20% decrease in biomarker (CA19-9) from baseline|1-year|Biomarker response (CA19-9) as defined by at least a 20% decrease from baseline|||participants|||Number
2813959|NCT00424827|Primary|Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1-year|Must have histologic confirmation of pancreatic adenocarcinoma with measurable disease per RECIST criteria, with locoregional disease not amenable to surgery were enrolled: based on(1) size of the tumor, 5cm; (2) lymph nodes; (3) vascular involvement or impingement on major vessels; and (4) invasion into the adjacent structures.|||months||95% Confidence Interval|Median
2813960|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 5|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.|||µM||Full Range|Mean
2813961|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 4|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.|||µM||Full Range|Mean
2813962|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 5|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.|||µM hr||Full Range|Mean
2813963|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 4|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.|||µM hr||Full Range|Mean
2813964|NCT00424775|Primary|Number of Participants With a Dose Limited Toxicity at First Cycle|Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.|25 Days (first cycle)|All participants who received vorinostat 300 mg once daily.|||Participants|||Number
2813965|NCT00424762|Secondary|Percentage of Patients Developing New or Worsening Peripheral Edema|clinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline|6 months||||percentage of patients|||Number
2813966|NCT00424762|Primary|Peak Oxygen Uptake (VO2)|measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute|6 months|completed baseline and end-of-study cardiopulmonary exercise test|||ml O2 uptake/kg fat-free mass/minute||Standard Deviation|Mean
2813967|NCT00424762|Secondary|Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months|proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%)|6 months|analysis limited to those with interpretable imaging data at baseline and end of study|||percentage of fat-to-water; %||Standard Deviation|Mean
2813969|NCT00424749|Secondary|Participants With Normalization of Eosinophil Count at 6 Months|Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.|6 months after beginning of remission induction regimen||||participants|||Number
2813970|NCT00424645|Primary|Patient Response Rate (Percentage)|Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level <0.1 µmol/L.|Study period 2 years|Analysis was to be per protocol, low accrual and early termination led too few responses for evaluation.||||||
2813971|NCT00424632|Secondary|Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue|Percentage of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.|||percentage of cells|||Number
2813972|NCT00424632|Secondary|Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735|Percentage of germ line polymorphism cell expression in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of LD of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.|||percentage of cells|||Number
2813973|NCT00424632|Secondary|Duration of Response|Duration of responses based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.|||months|||Number
2813974|NCT00424632|Secondary|Time to Progression|Time to Progression defined as the time from the date of enrollment to the date progressive disease first reported. If tumor progression data included more than 1 date, the first date was to be used. TTP = (first date of tumor progression - date of enrollment + 1). Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.|||months|||Number
2813975|NCT00424632|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.|||participants|||Number
2813976|NCT00424632|Secondary|Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC)|pH3 expression is a method to enable the quantification of the proliferative potential of tumor cells. Post-dose tumor tissue sampling occurred after FDG-PET. Biopsies were not to be taken from lesions which were used for PET analysis and were to be taken between 1 and 6 hours after study drug administration. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10|Data was not summarized as the development of the compound was discontinued.|||percentage of cells||Standard Deviation|Mean
2813977|NCT00424632|Secondary|Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|FTD-PET measured as standardized uptake volume (SUV) values corrected for lean body mass. Change from baseline categorized according to European Organization for Research and Treatment for Cancer (EORTC) criteria: Partial Metabolic Response (PMR): SUV value during treatment <75 percent (%) of baseline value; Progressive Metabolic Disease (PMD): SUV value during treatment >125% of baseline value; Stable Metabolic Disease (SMD): change in SUV value between PMR and PMD. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Baseline (Schedule A or Schedule B Day -7) and Schedule A Cycle 1/Day 3 or Day 4, Schedule B Cycle 1/Day 8 or 9|Data was not summarized as the development of the compound was discontinued.|||percent change||Standard Deviation|Mean
2813978|NCT00424632|Secondary|Urine Pharmacokinetics|Urine PK for quantification of unchanged PF-03814375 and any identified metabolites. 24-hour urine collection at 8-hour intervals after the morning dose (Schedule [Sch] A Day 4, Sch B Day 9; last sample collected just prior to the morning dose on Sch A Day 5 or Sch B Day 10 in the expanded maximum tolerated dose (MTD) cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups). The lower limit of quantification (LLOQ) was 1 nanogram per milliliter (ng/mL). Clinical specimens with concentrations below the LLOQ were to be reported as below the limited of quantification (BLQ) 1 ng/mL.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2813979|NCT00424632|Secondary|Terminal Half-life (t 1/2)|Terminal half-life (serum decay half-life) is the time measured for the serum concentration to decrease by one half.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Half-life (t ½) was not reported for multiple-dose data since the 24-hour sampling period was not long enough to adequately characterize t ½.|||hours||Standard Deviation|Mean
2813980|NCT00424632|Secondary|Observed Serum Accumulation Ratio (Rac)|Rac was the ratio of Schedule B Cycle 1/Day 9 to Day -5 (Day 9 AUCτ to Day -5 AUCτ).|Schedule B Day-5: pre-dose, 0.5, 1, 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dose, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set. N=number of participants in the indicated population contributing to the mean.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2813981|NCT00424632|Secondary|Minimum Observed Serum Trough Concentration (Cmin)|Cmin defined as the lowest serum concentration observed during the dosing interval.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2813982|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ).||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2813983|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.|||mcg*hr/mL||Full Range|Median
2813984|NCT00424632|Secondary|Time for Maximum Observed Serum Concentration (Tmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set|||hours||Full Range|Median
2813985|NCT00424632|Secondary|Maximum Observed Serum Concentration (Cmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Pharmacokinetic (PK) parameter analysis set: Enrolled participants who received at least 1 dose of study treatment who had at least 1 of the PK parameters of interest estimated in at least 1 treatment period.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2813986|NCT00424632|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3|DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.|Day 1 up to Day 21 of first cycle|Safety population: Same as the As-treated population, defined as all patients enrolled in the study that received at least 1 dose of the study medication.|||participants|||Number
2813987|NCT00424619|Secondary|Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months|The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres.|3 months|The number of participants who completed the 2WT is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional 2WT test at this time point.|||meters||Full Range|Mean
2813988|NCT00424619|Primary|Creatinine|Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.|Baseline||||µmol/L||Standard Deviation|Mean
2813989|NCT00424619|Primary|Hemoglobin|Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.|Baseline||||g/L||Standard Deviation|Mean
2813990|NCT00424619|Primary|Alkaline Phosphatase|Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.|Baseline||||U/L||Standard Deviation|Mean
2813991|NCT00424619|Primary|Phosphate|Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.|Baseline||||mmol/L||Standard Deviation|Mean
2813992|NCT00424619|Primary|Calcium|Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.|Baseline, 4 weeks||||mmol/L||Standard Deviation|Mean
2813993|NCT00424619|Primary|Parathyroid Hormone (PTH)|Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.|Baseline||||pmol/L||Standard Deviation|Mean
2813994|NCT00424619|Primary|25-hydroxyvitamin D3 (25-OHD)|Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).|Baseline, 4 weeks and 3 months|Baseline data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at <13 days were not included. 3-month data (n=47) was missing for 18 participants.|||nmol/L||95% Confidence Interval|Mean
2813995|NCT00424619|Secondary|Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months|"The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again. Scores are measured as time in seconds to complete the task."|3 months|The number of participants who completed the TUG test is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional TUG test at this time point.|||seconds||Full Range|Mean
2820936|NCT00377429|Secondary|Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)||2 years|Post study full analysis set|||weeks||Full Range|Median
2813996|NCT00424593|Other Pre-specified|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase|Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 through Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.|||participant|||Number
2813997|NCT00424593|Other Pre-specified|Serious Adverse Events During the Dose-Blind Extension Phase|Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 though Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.|||participants|||Number
2813998|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||kilograms (kg)||Standard Deviation|Mean
2813999|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||mm Hg||Standard Deviation|Mean
2814000|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||beats per minute (bpm)||Standard Deviation|Mean
2814001|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.|||micromole per Liter (μmol/L)||Standard Deviation|Mean
2814002|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2814003|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814004|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
2814005|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.~Absenteeism=(Q2/(Q2+Q4))*100~Presenteeism=(Q5/10)*100~Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100~Activity Impairment=(Q6/10)*100"|Baseline, Week 13, Week 54|"Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
2814006|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814019|NCT00424554|Secondary|Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)|An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.|12 months||||participants|||Number
2814007|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814008|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
2814009|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria|Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.|||participants|||Number
2814010|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria|Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.|||participants|||Number
2814011|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
2814012|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
2814013|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale|24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.|Baseline, Week 13|Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814014|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."|||units on a scale||Standard Deviation|Mean
2814015|NCT00424593|Secondary|Patient's Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 13|Number of participants with at least one non-missing post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814016|NCT00424593|Primary|Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of participants with baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2814017|NCT00424554|Secondary|MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days|||||||
2814018|NCT00424554|Secondary|Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days|||||||
2814020|NCT00424554|Secondary|Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities|"Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).~Grade 4 was defined as life-threatening per CTCAE."|12 months||||participants|||Number
2814024|NCT00424528|Secondary|Transition Dyspnea Index (TDI) Focal Score|TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Units on a scale||Standard Deviation|Mean
2814025|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day|Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.|2 weeks||||Actuations per day||95% Confidence Interval|Mean
2814026|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week|Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.|2 weeks||||Days per week||95% Confidence Interval|Mean
2814027|NCT00424528|Secondary|Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint||2 Weeks||||Liters||Standard Deviation|Mean
2814028|NCT00424528|Secondary|Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing|Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.|2 weeks|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
2814029|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.|||Hours||Full Range|Median
2814030|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.|||Hours||Full Range|Median
2814031|NCT00424528|Secondary|Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline|12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.|2 weeks||||Liters||95% Confidence Interval|Mean
2814032|NCT00424528|Secondary|Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.|2 weeks||||Percent of predicted FEV1||Standard Deviation|Mean
2814033|NCT00424528|Secondary|Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.|2 weeks||||Liters||Standard Deviation|Mean
2814034|NCT00424528|Secondary|Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)|Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.|Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
2814035|NCT00424528|Secondary|Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)||Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
2814036|NCT00424528|Secondary|Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)||0-12 hours following two weeks of dosing|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
2814037|NCT00424528|Primary|Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)||24 hours following two weeks of dosing.|Total number of subjects in each arm: 76, 80, 78|||Liters||95% Confidence Interval|Mean
2814038|NCT00424515|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
2814039|NCT00424515|Secondary|Time to Progression|Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
2814040|NCT00424515|Primary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.|||participants|||Number
2814041|NCT00424502|Secondary|C-Reactive Protein (CRP)|CRP was measured in milligrams per liter (mg/L).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.|||mg/L||Standard Deviation|Mean
2814042|NCT00424502|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was measured in mm/hr.|Day 0 and Week 24|All participants who received at least 1 dose of study drug.|||mm/hr||Standard Deviation|Mean
2814045|NCT00424502|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Day 0 and Week 24|All enrolled participants. n (number) = number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2814046|NCT00424502|Primary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 0 and Week 24|All enrolled participants who received at least one dose of study treatment.|||units on a scale||Standard Deviation|Mean
2814047|NCT00424489|Primary|Survival|Survival|Up to 5 years|Survival both treatment related and non-treatment related|||Participants|||Count of Participants
2814048|NCT00424476|Other Pre-specified|Adverse Events (AE) Overview|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 56 Weeks||||Percentage of participants|||Number
2814049|NCT00424476|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40 through 52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day|||Percentage of participants|||Number
2814050|NCT00424476|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a scale||Standard Error|Mean
2814051|NCT00424476|Secondary|Mean Change in Physician's Global Assessment (PGA) at Wk 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a 3-point scale||Standard Error|Mean
2814052|NCT00424476|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.||Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Percentage of participants|||Number
2814053|NCT00424476|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.|||Percentage of participants|||Number
2814054|NCT00424463|Secondary|Percentage of Participants With Abnormal Changes in Sensory Examinations||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
2814055|NCT00424463|Secondary|Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
2814056|NCT00424463|Secondary|Percentage of Participants With Adverse Drug Reactions||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
2814057|NCT00424463|Secondary|Percentage of Participants With Adverse Events||36 weeks (from seventh cycle to fifteenth cycle)||||percentage of participant|||Number
2814058|NCT00424463|Secondary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks|To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.|baseline (seventh cycle) and at 24 week (twelfth cycle)|"1 patient with diseases other than ALS and 4 patients with missing data were excluded from the FAS in the MCI-186 - Placebo of MCI-186group.~6 patients with missing data were excluded from the FAS in the MCI-186 - MCI-186 group.~19 patients with missing data were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group."|||percentage of FVC||Standard Deviation|Mean
2814059|NCT00424463|Secondary|Number of Participants With Death or a Specified State of Disease Progression|"Any of death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding was defined as an event."|24 weeks (from seventh cycle to twelfth cycle)|"1 patient with diseases other than ALS was excluded from the FAS in the MCI-186 - Placebo of MCI-186 group."|||Participants|||Count of Participants
2814501|NCT00422383|Secondary|Change From BL in Complement C3 Protein Level in g/L|The LLN of C3 protein was defined as <0.9 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
2814060|NCT00424463|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.|baseline (seventh cycle) and at 24 week (twelfth cycle)|"1 patient with diseases other than ALS and 4 patients with missing data were excluded from the FAS in the MCI-186 - Placebo of MCI-186group.~5 patients with missing data were excluded from the FAS in the MCI-186 - MCI-186 group.~14 patients with missing data were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group."|||units on a scale||Standard Deviation|Mean
2814061|NCT00424398|Secondary|Total Nasal Symptom|Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814062|NCT00424398|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814063|NCT00424398|Secondary|Ocular Mucus Discharge|Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with OMD Present|||Number
2814064|NCT00424398|Secondary|Tearing|Percent of Eyes with Tearing. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Percent of Eyes with Tearing Present|||Number
2814065|NCT00424398|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814066|NCT00424398|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814067|NCT00424398|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814068|NCT00424398|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814069|NCT00424398|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814070|NCT00424398|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814071|NCT00424398|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814072|NCT00424398|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814073|NCT00424398|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model||||Units on a scale||Standard Deviation|Mean
2814074|NCT00424385|Secondary|Time to Disease Progression (TTP)|Medium TTP is 2 months (range 1-5). 10 patients were evaluable for disease progression for these patients occurred between 1-5 months after starting the study. The TTP was calculated per protocol. For radiographic assessment Response Evaluation Criteria in Solid Tumors (RECIST) was used. Complete response = disappearance of all lesions. Partial response (PR)=30% or greater decrease in sum of longest diameter of measureable lesions SD. Lesions have no sufficient decrease for progressive disease and no sufficient increase to meet Progressive Disease (PD). PD more than 20% increase in sum of longest diameter of measurable lesions or 2 or more new bone mets. prostate-specific antigen (PSA) assessment for patients with measurable disease, PSA progression in the absence of measurable disease progression will not be considered progressive disease.|up to 5 cycles, an average of 20 weeks, from the day of first treatment until the date of the last dose of study drug||||months||Full Range|Median
2814075|NCT00424385|Secondary|Overall Clinical Benefit|Overall Clinical Benefit was measured as the sum of complete response (CR), partial response (PR), and stable disease (SD).|up to 20 weeks|There were 17 patients enrolled. 10 were evaluable for assessment of overall clinical benefit. 7 were not evaluable due to having received <1 cycle of drug.|||percentage of evaluable participants|||Number
2814076|NCT00424385|Primary|Number of Patients Experiencing Dose Limiting Toxicities (DLT's)|Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. If 2 out of six evaluable patients experience a dose limiting toxicity this would show that the Maximum Tolerated Dose (MTD) was the dose from the prior cohort.|up to 20 weeks|Cohort 0: 6 evaluable patients were enrolled. Patients who withdrew for reasons other than toxicity were not considered evaluable for MTD. 1 out of 6 patients had a DLT, therefore Cohort 1 was started. Cohort 1: 2 DLTs were demonstrated from 5 evaluable patients. By definition the Maximum tolerated dose was the dosing schedule used in cohort 0.|||participants|||Number
2814077|NCT00424372|Primary|Summary of Adverse Events|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.|52 weeks|Safety population: all subjects who took at least 1 dose of study medication.|||subjects|||Number
2814078|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale|Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||mm||Standard Deviation|Mean
2814079|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity|Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
2814080|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score|Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
2814081|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score|Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
2814082|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score|Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed|||score on scale||Standard Deviation|Mean
2814083|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate During the Extension Study|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 24, 36, 48, 60, 72 and 88.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||mm/hr||Standard Deviation|Mean
2814084|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels During the Extension Study|HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||mg/L||Standard Deviation|Mean
2814115|NCT00424294|Other Pre-specified|Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91||Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.|||beats per minute||Standard Deviation|Mean
2820937|NCT00377429|Secondary|Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||Baseline|2nd look laparoscopy/laparotomy|||Participants|||Number
2814085|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score During the Extension Study|The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
2814086|NCT00424346|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Extension Study|The physician's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
2814087|NCT00424346|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity During the Extension Study|"The patient's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
2814088|NCT00424346|Secondary|Change From Baseline in Patient's Pain Intensity During the Extension Study|The patient's assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
2814089|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||tender joints||Standard Deviation|Mean
2814090|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||swollen joints||Standard Deviation|Mean
2814091|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at the End of the Extension Study|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, patients were categorized as follows:~Did not attain an ACR20 response;~Attained a 20% but not a 50% response;~Attained a 50% but not a 70% response;~Attained a 70% or greater response.~A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and End of Study (up to 124 weeks)|Extension Study ITT population.|||participants|||Number
2814092|NCT00424346|Primary|Change From Baseline in Disease Activity Score (DAS) 28 During the Extension Phase|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) in mg/L;~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6"|Baseline and Weeks 24, 72 and 112|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).|||scores on a scale||Standard Deviation|Mean
2814116|NCT00424294|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.|Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2824861|NCT00346151|Secondary|Proportion of Participants With a Sirolimus Associated Adverse Event||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2814093|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders During the Extension Phase|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR70 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR70 evaluation data available.|||percentage of participants|||Number
2814094|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders During the Extension Phase|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR50 evaluation data available.|||percentage of participants|||Number
2814095|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders During the Extension Phase|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR20 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR20 evaluation data available.|||percentage of participants|||Number
2814096|NCT00424346|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F)|"The fatigue subscale of the FACIT is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants respond to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline FACIT-F value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Error|Least Squares Mean
2814097|NCT00424346|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Deviation|Mean
2814098|NCT00424346|Secondary|Change From Baseline in Rheumatoid Factor Concentration|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) that is an indicator of inflammation and rheumatoid arthritis.|Baseline and Weeks 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||kIU/L||Standard Deviation|Mean
2814099|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||mm/hr||Standard Deviation|Mean
2814185|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 02 March 2008; up to 51 months|Intent to Treat population includes all participants who were randomized.|||weeks||95% Confidence Interval|Median
2814100|NCT00424346|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) in mg/L;~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline DAS28 value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Error|Least Squares Mean
2814101|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels|"HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||mg/L||Standard Error|Least Squares Mean
2814102|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score|"The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."|||scores on a scale||Standard Error|Least Squares Mean
2814103|NCT00424346|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|"The physician's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by|||scores on a scale||Standard Error|Least Squares Mean
2814104|NCT00424346|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity|"The patient's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by|||scores on a scale||Standard Error|Least Squares Mean
2814105|NCT00424346|Secondary|Change From Baseline in Patient's Pain Intensity|"The patient's assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by|||scores on a scale||Standard Error|Least Squares Mean
2814106|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count|"The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."|||tender joints||Standard Error|Least Squares Mean
2814107|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count|"The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."|||swollen joints||Standard Error|Least Squares Mean
2814502|NCT00422383|Secondary|Percentage of Participants With Complement Component 3 (C3) Protein Level ≤ LLN|The LLN for C3 protein was defined as <0.9 grams per liter (g/L).|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||percentage of participants|||Number
2814108|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at Week 12|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, participants were categorized as follows:~Did not attain an ACR20 response;~Attained a 20% but not a 50% response;~Attained a 50% but not a 70% response;~Attained a 70% or greater response.~A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and Week 12|The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR evaluation. Last observation carried forward was applied for all the component variables.|||participants|||Number
2814109|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered ACR70 non-responders if they failed the ACR70 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR70 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."|||percentage of participants|||Number
2814110|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered ACR20 non-responders if they failed the ACR20 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR20 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."|||percentage of participants|||Number
2814111|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Weeks 2, 4 and 8|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 2, 4 and 8|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."|||percentage of participants|||Number
2814112|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Week 12|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Details on each of these components are provided in Outcome Measures 10-16. Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Week 12|The intent-to-treat (ITT) population consisted of all patients as randomized that received at least one dose of study drug and had at least one post-baseline efficacy assessment. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables.|||percentage of participants|||Number
2814113|NCT00424294|Other Pre-specified|Number of Participants With Categorical Vital Signs Data|Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.|Baseline, Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Detailed categorical data was not estimated since summarized continuous data of the vital signs were considered sufficient for the analysis as per investigator’s discretion.|||participants|||Number
2814114|NCT00424294|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.|Baseline up to Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
2814503|NCT00422383|Secondary|Change From BL in Anti-CCP Antibody Titers in U/mL||Weeks 8, 24, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||U/mL||Standard Deviation|Mean
2814117|NCT00424294|Secondary|Number of Participants With Clinical Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).|Baseline up to Week 13|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
2814118|NCT00424294|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||adverse events|||Number
2814119|NCT00424294|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
2814120|NCT00424294|Secondary|Time to Withdrawal Due to Lack of Efficacy||Baseline up to Week 12|Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis.||||||
2814121|NCT00424294|Secondary|Number of Participants Who Withdrew From Study Due to Lack of Efficacy||Baseline up to Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.|||participants|||Number
2814122|NCT00424294|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12|Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||hour||Standard Deviation|Mean
2814123|NCT00424294|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
2814124|NCT00424294|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2814125|NCT00424294|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
2814346|NCT00423293|Secondary|Five-year Rate of Overall Survival|Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 5 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814126|NCT00424294|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
2814127|NCT00424294|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||units on a scale||Standard Deviation|Mean
2814128|NCT00424294|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12|Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||mm||Standard Deviation|Mean
2814129|NCT00424294|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||swollen joints||Standard Deviation|Mean
2814130|NCT00424294|Secondary|Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.|||tender/painful joints||Standard Deviation|Mean
2814131|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.|||percentage of participants|||Number
2814132|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.|||percentage of participants|||Number
2814133|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.|||percentage of participants|||Number
2814134|NCT00424294|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method.|||percentage of participants|||Number
2814135|NCT00424268|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
2814136|NCT00424268|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
2814137|NCT00424268|Secondary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|24 weeks treatment period|ITT analysis|||exacerbations per patient per year||95% Confidence Interval|Mean
2814138|NCT00424268|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2814139|NCT00424268|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2814140|NCT00424255|Secondary|Number of Participants With the Indicated Worst-case On-therapy Left Ventricular Ejection Fraction (LVEF) Change From Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was assessed using echocardiogram (ECHO: a test of the action of the heart using ultrasound waves to produce a visual display, for the diagnosis or monitoring of heart disease ) and multigated acqusition scans (MUGA scan: a noninvasive diagnostic test used to evaluate the pumping function of the ventricles). Data from the ECHO and MUGA scans were combined, and the absolute change from Baseline (Abs) data are presented according to the following categories: No change or any increase, 0-<10% decrease, 10-19% decrease, >=20% decrease, >=10% decrease and >=the Lower Limit of Normal (LLN), >=10% decrease and below LLN, >=20% decrease and >=LLN, or >=20% decrease and below LLN. The relative percent change from Baseline (Rel) data are presented according to the following categories: >=20% decrease and >=LLN and >=20% decrease and below LLN.|From the end of the CRT until the last follow-up visit (average of 141 study weeks)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2814141|NCT00424255|Secondary|Number of Participants With the Indicated Biomarker Expression Status|Biomarkers (which influence clinical response) assessed from tumor tissues included P16, Human Papilloma virus (HPV), and Epidermal Growth Factor Receptor (EGFR)/Epidermal Growth Factor Receptor 1 (ErbB1). Biomarker expression is presented as positive, negative, or unknown. Participants in the ErbB1-positive category include those with results of positive or strongly positive.|Baseline (BL; within 8 weeks prior to randomization [Day 1]) (up to Study Week 1)|ITT Population|||Participants|||Number
2814142|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|Change from Baseline in quality of life status was assessed using the EQ-5D scale, a 5-item health status measure and a visual analog rating scale. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The EQ-5D is a generic measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. The EQ-5D covers health status in 5 domains (3 questions each): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each item is scored as follows: 1, no problems; 2, some moderate problems; 3, extreme problems. The possible EQ-5D index utility values range from 0.594 to 1, and the thermometer score ranges from 0 to 100. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2814143|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the Functional Assessement of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire|Change from Baseline in quality of life status was assessed using the FACT-H&N questionnaire, which is designed to measure multidimensional quality of life in participants with head and neck cancer. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The FACT-H&N questionnaire contains 39 items (27 general questions and 12 head and neck cancer-specific items) covering 4 dimensions and 1 subscale: physical well-being, social/family well-being, emotional well-being, functional well-being, and a head and neck cancer subscale. Possible subscale scores range from 0 to 36. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
2814347|NCT00423293|Secondary|Duration of Radiotherapy Treatment|Number of days from radiotherapy treatment start to radiotherapy treatment end|From start to end of radiation therapy (6 weeks)|Eligible patients who started IMRT|||Days||Full Range|Median
2814144|NCT00424255|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used by doctors and researchers to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Baseline (BL; within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population|||Participants|||Number
2814145|NCT00424255|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded at Baseline, at the end of the CRT, at Maintenance Week 56, at withdrawal from IP, and at anytime post-baseline. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if an abnormal ECG finding was CS or NCS.|Baseline (BL; within 8 weeks prior to randomization [Day 1]), End of CRT, Maintenance Week 56, Withdrawal from IP, and at any time Post-Baseline (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2814146|NCT00424255|Secondary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Kilograms||Standard Deviation|Mean
2814147|NCT00424255|Secondary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Degrees Centigrade||Standard Deviation|Mean
2814148|NCT00424255|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate (HR) was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Beats per minute||Standard Deviation|Mean
2814149|NCT00424255|Secondary|Change From Baseline in Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from investigational product (IP; up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2814150|NCT00424255|Secondary|Number of Participants With On-therapy and Follow-up Late Radiation Morbidity Events|Late radiation morbidity event data are summarized as the number of participants with late radiation morbidity events per system organ class (SOC). Late radiation effects are defined as those that first occur 90 days or more after the initiation of radiation therapy.|From 180 days after completion of radiation until the last follow-up/withdrawal visit (average of 64 study weeks)|Safety Population|||Participants|||Number
2814151|NCT00424255|Secondary|Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count.|From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2814152|NCT00424255|Secondary|Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit.|From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2814153|NCT00424255|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs.|From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks)|Safety Population|||Participants|||Number
2814154|NCT00424255|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received >=1 dose of lapatinib in error were included in the lapatinib arm.|From randomization until end of 1year maintenance treatment (average of 63 study weeks)|Safety Population (SP): all participants (par.) who were randomized and took >=1 dose of study medication. Only par. available at the specified time points were analyzed (represented by n=X, X in the category titles). Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.|||Weeks||Standard Deviation|Mean
2814155|NCT00424255|Secondary|Number of Participants With a Second Primary Tumor|Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by >2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring >=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage.|From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks)|ITT Population|||Participants|||Number
2814156|NCT00424255|Secondary|Time to Distant Relapse (TTDR)|TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
2814157|NCT00424255|Secondary|Time to Locoregional Recurrence (TTLR)|TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
2814158|NCT00424255|Secondary|Disease Specific Survival (DSS)|DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit.|From randomization until death due to head and neck cancer (average of 131 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
2814159|NCT00424255|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact.|From randomization until death due to any cause (average of 131 study weeks)|ITT Population|||Months||95% Confidence Interval|Median
2814186|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized.|||weeks||95% Confidence Interval|Median
2814160|NCT00424255|Primary|Disease Free Survival (DFS)|DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization.|From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, irrespective of whether they actually received study medication|||Months||95% Confidence Interval|Median
2814161|NCT00424190|Secondary|Assess Safety|Comparisons of the number of participants with Adverse Events|First dose of study drug through TOC visit|||||||
2814162|NCT00424190|Secondary|Microbiological Reinfection or Recurrence at the LFU Visit||21 to 35 days after the last dose of study drug|||||||
2814163|NCT00424190|Secondary|Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug|||||||
2814164|NCT00424190|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug|||||||
2814165|NCT00424190|Secondary|Clinical Response at the End of Therapy (EOT) Visit||Last day of study drug administration|||||||
2814166|NCT00424190|Secondary|Microbiological Success Rate at the TOC Visit||8-15 days after last dose of study drug|||||||
2814167|NCT00424190|Primary|Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug|||||||
2814168|NCT00424190|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome"|8-15 days after the end of treatment|MITT (Modified Intent to Treat) - Any randomized subjects that received any amount of study drug|||participants|||Number
2814169|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score|ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1|||participants|||Number
2814170|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale|World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1|||participants|||Number
2814171|NCT00424177|Secondary|Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up|Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa|Up to 1 year|Safety Population: any participant who received at least 1 dose of study medication|||participants|||Number
2814172|NCT00424177|Secondary|Number of Participants Who Required Rescue Medication|New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy|Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag|ITT Population|||participants|||Number
2814173|NCT00424177|Secondary|Changes in Participants' Platelet Counts During 3 Cycles of Treatment|Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.|Up to 1 year|Intent-to-Treat (ITT) Population: All participants who were dispensed study medication|||Gi/L||Full Range|Median
2814174|NCT00424177|Secondary|Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.|CBC, platelet counts|Up to 42 days of dosing|Cycle 1 responders|||participants|||Number
2814175|NCT00424177|Primary|Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1|Complete blood count, platelet count by blood draw|Day 42 of each cycle|Primary Analysis Population: All participants who entered the study, received at least 1 dose of eltrombopag, and responded in Cycle 1|||participants|||Number
2814176|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 Mar 2008; up to 51 months|Intent to Treat population includes all participants who were randomized to study drug.|||weeks||95% Confidence Interval|Median
2814187|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 03 August 2005; up to 24 months|Intent to treat included all participants who were randomized.|||weeks||95% Confidence Interval|Median
2814177|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 02 March 2008; up to 51 months|Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.|||weeks||95% Confidence Interval|Median
2814178|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 03 August 2005; up to 24 months|Intent to Treat includes all participants who were randomized to study drug; a total of six ECOG scores were missing at the time of the Aug 2005 cut-off.|||weeks||95% Confidence Interval|Median
2814179|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 02 March 2008; up to 51 months|Intent to treat included all participants who were randomized.|||weeks||95% Confidence Interval|Median
2814180|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized to study drug.|||weeks||95% Confidence Interval|Median
2814181|NCT00424047|Secondary|Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)|Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).|Up to unblinding data cut off of 03 August 2005; up to 24 months|Analysis not performed due to an insufficient number of participants with SRE|||participants|||Number
2814182|NCT00424047|Secondary|Number of Participants With Adverse Events (AE)|"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.~The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months|The safety population includes all participants who received at least one dose of study drug regimen|||participants|||Number
2814183|NCT00424047|Secondary|Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to data cut-off of 02 Mar 2008; up to 51 months|Intent to Treat Population includes all participants who were randomized|||percentage of participants|||Number
2814184|NCT00424047|Secondary|Summary of Myeloma Response Rates Based on Best Response Assessment|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to 03 August 2005; up to 24 months|Intent to Treat Population includes all participants who were randomized|||percentage of participants|||Number
2814504|NCT00422383|Secondary|Anti-Cyclic Citrullinated Peptide (CCP) Antibody Titers at BL in Units Per mL (U/mL)||BL|SAP. 3, 3, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, and High Dose, groups, respectively.|||U/mL||Standard Deviation|Mean
2814188|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.|||Participants|||Number
2814189|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.|||Participants|||Number
2814190|NCT00424021|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study) was evaluated during the AMB-220-E study period.|||Probability (%)|||Number
2814191|NCT00424021|Secondary|Failure-free Treatment Status|Failure-free treatment status was defined as the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the NCT00046319 study) was evaluated during the NCT00046319 and AMB-220-E study periods.|||Probability (%)|||Number
2814192|NCT00424021|Secondary|Time to Clinical Worsening of PAH|Clinical worsening of PAH was defined as death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Sildenafil, a type 5 phosphodiesterase (PDE-5) inhibitor, had not received regulatory approval for the treatment of PAH until late in the conduct of AMB 220 and AMB 220-E, and did not count toward clinical worsening. Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the AMB-220 study) was evaluated during the NCT00046319 and AMB-220-E study periods.|||Probability (%)|||Number
2814193|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)|"The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent."|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814194|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)|"The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent."|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814195|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)|"The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent."|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814196|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)|"The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent."|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814197|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])|"The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent."|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|||Units on a Scale||Standard Deviation|Mean
2814348|NCT00423293|Secondary|Clinical Complete Response Rate|A complete clinical response was defined as complete resolution of all palpable tumor determined by digital rectal exam and proctosigmoidoscopy supplemented with pelvic axial imaging.|8 and 12 weeks after treatment completion (corresponding to 14 and 18 weeks from registration)|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814198|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|180 weeks (Week 24 of NCT00046319 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
2814199|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|132 weeks (Week 24 of NCT00046319 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
2814200|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|84 weeks (Week 24 of NCT00046319 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
2814201|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)||||Participants|||Number
2814202|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Participants|||Number
2814203|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814204|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814205|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814365|NCT00423189|Primary|Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)|Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.|1 Year|As per subjects participated|||participants|||Number
2815188|NCT00418262|Primary|Pittsburg Side-Effects Scale: Dull/Tired/Listless|"Dull/Tired/Listless~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from the RCT did not enter the open label study|||units on a scale||Standard Deviation|Mean
2814206|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814207|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Units on a Scale||Standard Deviation|Mean
2814208|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
2814209|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
2814210|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
2814211|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
2814212|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.|||Meters||Standard Deviation|Mean
2814213|NCT00424021|Primary|Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 334|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.|||Participants|||Number
2814214|NCT00424008|Secondary|The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period.|For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline proportion of symptom-free days/nights as a covariate."|||Proportion of symptom-free days/nights||Standard Deviation|Least Squares Mean
2814215|NCT00424008|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint|The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any postbaseline data (intent-to-treat principle).~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline ACQ score as a covariate."|||Scores on a scale||Standard Deviation|Least Squares Mean
2814216|NCT00424008|Secondary|Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1|PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval.|Baseline to 5 minutes post-dose on Day 1|"Participants with data at Day One 5 minutes post-dose.~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate."|||Liters||Standard Deviation|Least Squares Mean
2814217|NCT00424008|Primary|The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)||Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate.|||Liter x hour||Standard Deviation|Least Squares Mean
2814218|NCT00423943|Secondary|Change in Negative Symptoms|Change in average score, ranging from 0 (absent) to 5 (severe), on on Scale for the Assessment of Negative Symptoms (SANS) from baseline to 4-week time-point. Decreased values indicate improved clinical status (lesser symptom severity).|Baseline, 4 weeks||||units on SANS scale||Standard Deviation|Mean
2814219|NCT00423943|Secondary|Change in Positive Symptoms|Change in Average score (range 0-5) on the Scale for Assessment of Positive Symptoms (SAPS) from baseline to 4 week time-point, ranging from 0 (absent) to 5 (severe). Decreased values indicate improved clinical status (lesser symptom severity).|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2814220|NCT00423943|Primary|Gamma Power Change in Count of Clusters|Power in Gamma frequency range by scalp electrophysiology after single-dose and after 4-week treatment: Count of Clusters (defined as those with statistically-significant Task-Related Increase, i.e. relatively larger value of wavelet coefficient in wavelet analysis of signal) for high-control (i.e. difficult) condition versus Low-control (i.e. easy) condition, in Oscillatory Power in Time-Frequency Spectrogram. Increased values indicate improved function.|4 weeks|2 subjects in the Drug arm refused to perform EEG.|||Count of Positive Power Clusters||Standard Deviation|Mean
2814221|NCT00423943|Primary|Control-related BOLD Signal Change in Locus Coeruleus|BOLD signal change on high-control (i.e. difficult) condition versus low-control (i.e. easy) condition, on Preparing to Overcome Prepotency Task, measured by fMRI after 4-week treatment.|4 weeks||||beta coefficient of BOLD signal change||Standard Deviation|Mean
2814222|NCT00423943|Primary|Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task|Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance.|Baseline, 4 weeks||||percent change in accuracy||Standard Deviation|Mean
2814223|NCT00423930|Secondary|Overall Survival Rate: Percentage of Participants Who Survived||2 years||||percentage of participants||95% Confidence Interval|Number
2814224|NCT00423930|Primary|Progression-free Survival at 2 Years|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Percentage of Participants Experiencing Progression-free Survival at 2 Years||||percentage of participants||95% Confidence Interval|Number
2814225|NCT00423917|Secondary|Duration of Response/Time to Disease Progression in Patients With Measurable Disease|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 5 years|Evaluable patients with measurable disease who experienced a confirmed response.|||months||95% Confidence Interval|Median
2814226|NCT00423917|Secondary|Time to First Cytotoxic Agent|Time to first dose of a cytotoxic agent is defined to be the time from the date of registration to the date at which a patient recieves the first dose of a cytotoxic agent. The distribution of time to first dose of a cytotoxic agent will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years||||months||95% Confidence Interval|Median
2814585|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 104|Calculated as mean waist circumference at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||cm||Standard Deviation|Mean
2814227|NCT00423917|Secondary|Objective Response Rate as Measured by RECIST Criteria in Patients With Measurable Disease|A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
2814228|NCT00423917|Secondary|Quality of Life, as Measured by the Largest Mean Change in LASA Overall QOL and Physical Well-being Items|Quality of life (QOL) assessment will be a secondary exploratory component of this trial. QOL of patients was measure using the 6-item Linear Analogue Self-Assessment (LASA).The LASA consists of six single-item numeric analog scales measuring overall QOL; mental, physical, emotional, and spiritual well-being; and level of activity each on a scale of 0 ('As bad as it can be') to 10 ('As good as it can be') during the past week. Items were transformed to a 0 (worst QOL or well-being) to 100 (best QOL or well-being) scale for statistical analysis. Mean change from baseline of the largest mean change in overall QOL and physical well-being are reported below.|Up to 5 years||||mean change in LASA QOL scaled score||Standard Deviation|Mean
2814229|NCT00423917|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).|Up to 5 years||||months||95% Confidence Interval|Median
2814230|NCT00423917|Secondary|Progression Free Survival|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 5 years||||months||95% Confidence Interval|Median
2814231|NCT00423917|Primary|Six-month Progression-free Survival (PFS) Rate at 6 Months|The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Additionally, if some patients are lost to follow-up not having been observed for at least 6 months, an estimate and 95% confidence interval for the 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months||||percentage of patients||95% Confidence Interval|Number
2814232|NCT00423891|Secondary|Number of Participants With Electrolyte Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO) for chloride. Milliequivalents per liter (mEq/L); Grade (Gr). Chloride high (mEq/L): Gr1: 113-<117; Gr2: 117-<121; Gr3: 121-125; Gr4: >125. Potassium low (mEq/L): Gr1: 3.0-3.4; Gr2: 2.5-2.9; Gr3:2.0-<2.4; Gr4: <2.0. Potassium high: Gr1; 5.6- <6.0; Gr2: 6.1-<6.5; Gr3: 6.6-7.0; Gr4: >7.0. Sodium high (mEq/L): Gr1; 146-<150; Gr2: 151-<154; Gr3: 155-<159; Gr4: >=160.|Day 1 Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).|||participants|||Number
2814233|NCT00423891|Secondary|Number of Participants With Chemistry Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO). Grade (Gr). ALT: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0 *ULN; Gr3: 5.1-10.0*ULN; Gr4:>10.0*ULN. Aspartate aminotransferase (AST): Gr1: 1.25-<2.5*ULN; Gr2:2.6-<5.0*ULN; Gr 3: 5.1-10.0*ULN; Gr4>10.0*ULN. Alkaline phosphatase: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0*ULN; Gr3: 5.1-10.0*ULN; Gr4: >10.0*ULN. Lipase: Gr1:1.1-<1.5*ULN;Gr2:1.6-<3.0*ULN; Gr3: 3.1-5.0*ULN; Gr4: >5.0*ULN. Creatinine: Gr1: 1.1-1.3*ULN; Gr2: 1.4-<1.8*ULN; Gr3: 1.9 - <3.4*ULN; Gr4: >=3.5*ULN. Glucose mg/dL (high): Gr1:110-<125 (Fasting)/116-<160;Gr2:126-<250 (F)/161-<250; Gr3: 251-500; Gr4: >500.Glucose (low): Gr1: 55-64; Gr2: 40 - <54; Gr3: 30-39; Gr4: <30 mg/dL.|Day 1 to Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).|||participants|||Number
2814234|NCT00423891|Secondary|Number of Participants With Hematology Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: Division of AIDs (DAIDS) grades Version 1.0. Upper limit of normal (ULN); lower limit of normal (LLN); Cells per Liter (c/L); cells per microliter (c/µL); grams per deciliter (g/dL); milliequivalents per liter (mEq/L); cells per microliter (c/µL): Grade (Gr). Hemoglobin g/dL: Gr1:10.0-10.9;Gr2: 9.0-9.9; Gr3:7.0-8.9; Gr4: <7.0. International normalization ratio (INR): Gr1:1.1-<1.5*ULN; Gr2: 1.6-<2.0*ULN; Gr3: 2.1-3.0*ULN;Gr4: >3.0*ULN. Neutrophils/bands c/µL: Gr1;1.0-1.3*10^3; Gr2: 0.75-0.99*10^3; Gr 3: 0.50-0.749*10^3; Gr4: <0.5*10^3.|Day 1 to Week 120|Participants who received at least 1 dose of study therapy, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).|||participants|||Number
2814376|NCT00423098|Secondary|Number of Patients With Partial Remission|Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.|Baseline to 12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||Participants|||Number
2821800|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Pre Intervention||||units on a scale||Standard Deviation|Mean
2814235|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Without HBeAg Seroconversion, Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HBeAb. The method used for the detection of HBeAg/Ab serologies was the DiaSorin enzyme immunoassay kit.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814236|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Plus HBeAg Seroconversion Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion was determination of presence of HBeAb and loss of HBeAg. The method used for the detection of HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814237|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814238|NCT00423891|Secondary|Number of Participants With HBV DNA by PCR Categories at Weeks 48 and 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline, Week 48, Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814239|NCT00423891|Secondary|Alanine Aminotransferase (ALT) Normalization From Baseline Through Week 96 in Treated Participants|Normalization in ALT= ALT ≤ 1.0*upper limit of normal (ULN). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814240|NCT00423891|Secondary|Mean Log10 Change From Baseline in HBV DNA Using Roche COBAS TaqMan - HPS Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. HBV DNA log10 changes from baseline were summarized over time.|Baseline to Week 96|Participants who received at least one dose of study drug, and had a measurement at baseline and at the specific analysis week.|||IU/mL||Standard Error|Mean
2814241|NCT00423891|Secondary|Number of Participants Who Had a Protocol Defined Response (PDR) Through Week 96 in Treated Participants|PDR was defined as confirmed HBV DNA < 50 IU/mL plus confirmed HBeAg seroconversion on 2 sequential measurements at least 14 days apart. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814242|NCT00423891|Secondary|Number of Participants With HB s Antigen (HBsAg) Seroconversion Through Week 96 in Treated Participants|HB s Ag seroconversion: loss of HBsAg (HBsAg negative) and presence of HB s antibodies (HBsAb). The method used for the detection of HBsAg seroconversion was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814243|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Quantification (LLQ) for the Roche COBAS TaqMan - HPS Assay Through Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814377|NCT00423098|Secondary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.|12 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||participants|||Number
2814244|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Detection (LLD) for the Roche COBAS TaqMan - HPS Assay at Week 96 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLD = 6 IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814245|NCT00423891|Primary|Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.|Day 1 to Week 120|All participants who received at least one dose of study drug. On-treatment period began on the first day of study therapy and ended 5 days after the last dose of study therapy.|||participants|||Number
2814246|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen Seroconversion Through Week 96 in Treated Participants|HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HB e antibodies (HBeAb), ie both the presence of HBeAb and the absence of HBeAg. The method used for the detection HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814247|NCT00423891|Secondary|Number of Participants With Hepatitis B s Antigen (HBsAg) Loss Through Week 96 in Treated Participants|HBsAg loss: HBsAg negative. The method used for detection of HBsAg was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814248|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss Through Week 96 in Treated Participants|HBeAg loss: HBeAg negative. The method used for the detection of HBe Ag was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814249|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants|Hepatitis B virus DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS TaqMan - high pure system (HPS) assay and was reported in international units per milliliter (IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 96|The intent-to-treat method of Non-Completer = Failure was used through Week 48 in which all treated participants were analyzed, and participants with missing data at the analysis week were considered failures. After Week 48, the method of Non-Completer = Missing was used, in which participants with missing data at the analysis week were excluded.|||participants|||Number
2814250|NCT00423891|Secondary|Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|CLT/F was calculated by dividing the dose of ETV by AUC(TAU) of ETV and was measured in liters per hour (L/h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|At 2 weeks|Participants in Groups A and B who received study drug and had PK assessment.|||L/h||Standard Deviation|Mean
2814251|NCT00423891|Secondary|Mean Area Under the Concentration-Time Curve in One Dosing Interval [AUC(TAU)] of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Area under the Curve (AUC) was derived from plasma concentration of ETV versus time. AUC(TAU) was calculated by log- and linear trapezoidal summations, TAU = 24 hours, and was measured in nanograms*hours per milliliter (ng*h/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2814252|NCT00423891|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort|Tmax was derived from plasma concentration of ETV versus time and measured in hours (h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Age categories presented below: participants age as of first day of dosing. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.|||h||Full Range|Median
2814253|NCT00423891|Secondary|Mean Maximum Observed Plasma Concentration (Cmax) and Mean Trough Observed Plasma Concentration (Cmin) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Cmax and Cmin were derived from plasma concentration of ETV versus time and measured in nanograms per milliliters (ng/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Note: PK parameters were summarized for only Groups A and B. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2814254|NCT00423878|Secondary|Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)||Measured at Month 6|2 participants who never took assigned study medication were excluded.|||participants|||Number
2814255|NCT00423878|Primary|Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks|Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.|24 weeks|The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.|||mg/dL non-HDL cholesterol||Standard Error|Least Squares Mean
2814256|NCT00423852|Primary|Maximum Tolerated Dose of Ifosfamide||4 years||||mg/m2|||Number
2814257|NCT00423852|Primary|Response|"Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)~Complete Response (CR): A complete response is defined as one of the following:~Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).~Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.~Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks."|2 year||||participants|||Number
2814258|NCT00423813|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14||||Percentage of Participants|||Number
2814259|NCT00423800|Secondary|Number of Participants With a Virological Relapse|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).~Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment."|24 weeks following completion of 24 or 48 weeks of therapy|ITT population that completed the study.|||Participants|||Number
2814260|NCT00423800|Primary|Number of Participants With a Sustained Virologic Response|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.~Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder."|24 weeks following completion of 24 or 48 weeks of therapy||||Participants|||Number
2814261|NCT00423735|Secondary|Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy|Sufficient pharmacokinetic data was not obtained.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|||||||
2814262|NCT00423735|Secondary|Correlation of Molecular Markers and Tumor Response|The following markers were examined: p-SRC, PDGFR, EPHA2, c-KIT. Patients were categorized based on the number of positive molecular markers they had: 2 vs. 3 and 4. Correlation of marker category and best tumor response was tested using Fisher's exact test. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression up to six months. Patients are combined from the two treatment arms.|From registration to 6 months|Eligible patients who started study treatment and whose response was assessed|||Participants|||Count of Participants
2814263|NCT00423735|Secondary|Rate of Adverse Events|The rate of patients' worst overall grade of adverse event is reported. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started protocol treatment|||percentage of participants|||Number
2814378|NCT00423098|Primary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.|24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||Participants|||Number
2814264|NCT00423735|Secondary|Progression-free Survival|Progression-free survival time is measured from randomization to the date of first progression or death, else the last follow-up date on which the patient was reported alive, and is estimated by the Kaplan-Meier method. Progression is defined as ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment|||months||95% Confidence Interval|Mean
2814265|NCT00423735|Secondary|Treatment Response Rates at Six Months|Best response is assessed using standard criteria for patients with malignant gliomas (Macdonald 1990) as reported by the site. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; neurologically worse; steroids stable/increased. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression, up to six months. The study is not designed for a comparison of the treatment arms to each other.|From registration to 6 months|Eligible patients who started study treatment|||percentage of participants|||Number
2814266|NCT00423735|Secondary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. The study is not designed for a comparison of the treatment arms to each other.|Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months. Arms are not compared.|||months||95% Confidence Interval|Median
2814267|NCT00423735|Secondary|Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)|Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint. Complete Response: Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial Response: ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved.|Registration to 6 months|Eligible patients who started protocol treatment.|||participants|||Number
2814268|NCT00423735|Primary|Number of Patients Achieving 6-month Progression-free Survival (6mPFS)|This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.|Registration to 6 months|Eligible patients who started protocol treatment.|||participants|||Number
2814269|NCT00423722|Secondary|Change in Dehydration as Measured by Dehydration Assessment Scale|Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.|Baseline to Day 7||||units on a scale||Standard Deviation|Mean
2814270|NCT00423722|Secondary|Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)|Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.|Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)||||units on a scale||Inter-Quartile Range|Mean
2814271|NCT00423722|Secondary|Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7|"Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) & FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional & functional well being & relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue & its related symptoms on a scale of 0-4 from 0 not at all to 4 very much. The responses to FACIT fatigue questionnaire are each measured on 4‐point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7."|Baseline to Day 7||||units on a scale||Standard Deviation|Mean
2814272|NCT00423722|Secondary|Reduced Symptom Burden as Measured by RASS, MDAS and UMRS|"Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is Combative to -5 is Unarousable; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0)."|Baseline to Day 7||||units on a scale||Inter-Quartile Range|Median
2814273|NCT00423722|Primary|Participant Reduced Symptom Burden|Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.|From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)||||units on a scale||Standard Deviation|Mean
2814274|NCT00423683|Secondary|Resolution of PE||3 years or until death|33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites|||percentage of PE sites|Participants||Number
2814275|NCT00423683|Secondary|Resolution of DVT||3 years or until death|33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites|||percentage of DVT sites|Participants||Number
2814276|NCT00423683|Secondary|Overall Survival||3 years or until death||||days||95% Confidence Interval|Median
2814277|NCT00423683|Primary|Adverse Outcomes|Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs|3 years or until death||||percentage of participants|||Number
2814278|NCT00423670|Secondary|Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR|"Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL."|At FW 24 up to EOF and at 72 weeks post randomization|Participants who achieved SVR.|||Participants|||Number
2814279|NCT00423670|Secondary|Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR|"Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12 and FW 24 up to EOF|Participants with undetectable HCV-RNA at FW 12.|||Participants|||Number
2814280|NCT00423670|Secondary|Number of Participants With an Early Virologic Response (EVR) That Achieved SVR|"Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At TW 12, and at FW 24 up to EOF|Participants with an early virologic response (EVR).|||Participants|||Number
2814281|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization|"Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|72 weeks post randomization||||Participants|||Number
2814282|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at FW 12|"Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
2814283|NCT00423670|Secondary|Number of Participants With SVR Based on Duration of Boceprevir Treatment|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
2814284|NCT00423670|Secondary|Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
2814285|NCT00423670|Primary|Number of Participants With Sustained Virologic Response (SVR)|"Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).~A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR."|From follow-up week (FW) 24 up to end of follow-up (EOF)|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).|||Participants|||Number
2814286|NCT00423657|Secondary|To Evaluate Safety||first study drug dose through TOC|||||||
2814287|NCT00423657|Secondary|To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit||21-35 days after last dose of study drug|||||||
2814288|NCT00423657|Secondary|To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug|||||||
2814289|NCT00423657|Secondary|To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug|||||||
2814290|NCT00423657|Secondary|To Evaluate the Clinical Response at the End of Therapy (EOT) Visit||last day of study drug administration|||||||
2814291|NCT00423657|Secondary|To Evaluate the Microbiological Success Rate at the TOC Visit||8-15 days after the last dose of study drug|||||||
2814292|NCT00423657|Primary|The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.||8-15 days after last dose of study drug|||||||
2814293|NCT00423657|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug administration|MITT (Modified Intent to Treat) - all subjects that received any amount of study drug|||participants|||Number
2814294|NCT00423605|Primary|Number of Subjects Reporting Adverse Events|Number of subjects reporting adverse events.|Treatment Period (38 weeks)||||Participants|||Number
2814295|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814296|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814297|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814298|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814299|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814586|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 20|Calculated as mean waist circumference at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||cm||Standard Deviation|Mean
2814300|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814301|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814302|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814303|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814304|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814305|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Participants|||Number
2814306|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise|Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||Units on a scale||Standard Deviation|Mean
2814307|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD)|The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.|||meters||Standard Deviation|Mean
2814308|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.|||participants|||Number
2814477|NCT00422591|Secondary|Event-Free Survival (EFS)|Event -Free Survival (EFS) EFS was calculated with Kaplan-Meier estimates. Event-free survival (EFS), defined as the time to no response to intensive induction therapy, relapse, or death of any cause, whichever comes first.|from treatment initiation until treatment failure, relapse, or death||||Months||95% Confidence Interval|Median
2814309|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.|||participants|||Number
2814310|NCT00423592|Primary|The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.|||Participants|||Number
2814311|NCT00423579|Primary|Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks|Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.|Baseline and 6 weeks|Intent-to-treat population only.|||percentage change||Standard Deviation|Mean
2814312|NCT00423488|Primary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment||6 weeks of treatment (from Baseline to Endpoint)|Intent-to-treat population only.|||percentage change||Standard Deviation|Mean
2814313|NCT00423449|Primary|Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease|"Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.~The MTD was 400 mg for up to 10 days in 21-day cycles."|every 21 days (every cycle), up to 126 days (6 cycles)||||mg|||Number
2814314|NCT00423449|Secondary|Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)|"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)||||Participants|||Number
2814315|NCT00423449|Secondary|Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)|"An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)||||Participants|||Number
2814316|NCT00423449|Primary|Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin|DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.|every 21 days (every cycle), up to 126 days (6 cycles)||||Participants|||Number
2814317|NCT00423436|Primary|Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments|Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.|Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)|Analysis was per protocol. Due to attrition, data from 61 participants were analyzed at end of first chemotherapy cycle and from 27 participants at the end of the study.|||Ratio of alerts/number of assessments|Participants||Number
2814318|NCT00423358|Secondary|Short Form 36 Survey|12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function|1 Year|Intent to treat analysis|||units from 0 (worst) to 100 (best)||95% Confidence Interval|Mean
2814319|NCT00423358|Secondary|Bone Mineral Density|one year change in mean total hip BMD|1 Year|Intent to treat analysis|||g/cm2||Standard Deviation|Mean
2814320|NCT00423358|Primary|Parathyroid Hormone Level|Serum parathyroid hormone level|1 Year|Subject data were analyzed using the intent to treat approach.|||pg/mL||Standard Deviation|Mean
2814452|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response"|"The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively."|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
2814321|NCT00423332|Secondary|Best Objective Tumour Response|Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).|Baseline, Week 12 and every 8 weeks thereafter or until progression.|For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a ‘best response’ summary.|||Participants|||Number
2814322|NCT00423332|Secondary|Objective Tumour Response at 12 Weeks|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.|Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.||||Participants|||Number
2814323|NCT00423332|Secondary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Treatment period up to 2nd data cut-off of 8th March 2009.|Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib.|||Months||Full Range|Median
2814324|NCT00423332|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period up to 2nd data cut-off of 8th March 2009|"For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)).~13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off."|||Months||Inter-Quartile Range|Median
2814325|NCT00423332|Secondary|Best Percentage Change From Baseline in Tumour Size During the Study|Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions|Treatment period up to Week 12 visit date for last patient in (LPI)|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.|||Percentage change from baseline||Standard Deviation|Mean
2814326|NCT00423332|Primary|Percentage Change From Baseline in Tumour Size at 12 Weeks|Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100|Baseline to Week 12|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data|||Percentage change from baseline||Standard Deviation|Mean
2814327|NCT00423319|Secondary|Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants who received at least 1 dose of study drug|||Percent of events/patients evaluated||95% Confidence Interval|Number
2814328|NCT00423319|Secondary|Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period|Treatment guidelines were provided for jaundice and elevated results of liver function tests.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814329|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814330|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814331|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814332|NCT00423319|Secondary|Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period|Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814333|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814334|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814335|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2814336|NCT00423319|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study medication|||Participants|||Number
2814345|NCT00423293|Secondary|Five-year Rate of Disease-free Survival|Disease-free survival time is defined as time from registration to the date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Local failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.|From registration to 5 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814337|NCT00423319|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug|||Percentage of events/patients evaluted||95% Confidence Interval|Number
2814338|NCT00423319|Secondary|Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period|VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants randomized to treatment|||Percentage of events/patients evaluated|||Number
2814339|NCT00423319|Secondary|Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|Randomized participants with either an adjudicated event or an adjudicated evaluable bilateral venogram|||Percentage of events/patients evaluated||95% Confidence Interval|Number
2814340|NCT00423319|Primary|Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, had an adjudicated venous thromboembolic event, or died of any cause.|||Percentage of events/patients evaluated||95% Confidence Interval|Number
2814341|NCT00423293|Secondary|Five-Year Rate of Colostomy-free Survival|Colostomy-free survival time is defined as time from registration to date of colostomy or abdominoperineal (A-P) resection, or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.|From registration to 5 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814342|NCT00423293|Secondary|Five-Year Cumulative Incidence Rate of Colostomy Failure|Colostomy failure time is defined as time from registration to the date of colostomy or abdominoperineal (A-P) resection and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.|From registration to 5 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814343|NCT00423293|Secondary|Five-Year Cumulative Incidence Rate of Distant Failure|Distant failure time is defined as time from registration to the appearance of distant metastases and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact.|From registration to 5 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814344|NCT00423293|Secondary|Five-Year Cumulative Incidence Rate of Local-regional Failure|Local-regional failure time is defined as time from registration to date of failure and is estimated by the cumulative incidence method. Patients last known to be alive without failure are censored at the date of last contact. Local-regional failure is defined as a local or regional failure. Local failure is defined as any measurable disease after 12 weeks from the completion of chemoradiation therapy. Regional failure is defined as: a) For patients with no disease in pelvic and/or groin nodes, the appearance of disease in pelvic or groin nodes; b) For patients with disease in pelvic and/or groin nodes at study entry, nodal recurrence following clearance or persistent nodal disease for more than 12 weeks after completion of treatment.|From registration to 5 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2814478|NCT00422591|Primary|Complete Response (CR) Rate|Complete Response (CR): Normalization of marrow (< 5% blasts; >10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count > 109/L, platelet count > 100 x 109/L).|Up to 2 months||||Participants|||Count of Participants
2814349|NCT00423293|Secondary|Percentage of Subjects With Late Adverse Events (AE)|Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Late toxicities occur greater than 90 days from the start of treatment.|From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 9.2 years.|Eligible patients who started IMRT and were on-study > 90 days from the start of treatment (or did not withdraw consent until after 90 days).|||percentage of participants||95% Confidence Interval|Number
2814350|NCT00423293|Secondary|Percentage of Subjects With Acute Adverse Events (AE)|Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.|From the start of treatment to 90 days|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
2814351|NCT00423293|Secondary|Number of Patients With Major Radiation Planning Deviations|Deviations in intensity-modulated radiation therapy technique (IMRT) planning were determined by central review by the radiation oncology co-chairs of the study.|Planning occurred prior to radiation therapy|All eligible patients who started IMRT|||Participants|||Count of Participants
2814352|NCT00423293|Primary|Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)|Highest grade adverse event per subject were counted. Adverse events were graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Acute toxicities occur within 90 days of the start of treatment.|From the start of treatment to 90 days|Eligible patients with adverse event information.|||percentage of participants||95% Confidence Interval|Number
2814353|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B||12 months||||Participants|||Number
2814354|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A||12 months||||Participants|||Number
2814355|NCT00423267|Secondary|Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months||||Participants|||Number
2814356|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.~Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months||||Participants|||Number
2814357|NCT00423267|Secondary|Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months||||Participants|||Number
2814358|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months||||Participants|||Number
2814359|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months||||Participants|||Number
2814360|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.~Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months||||Participants|||Number
2814361|NCT00423189|Secondary|Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab|Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.|1 Year|||||||
2814362|NCT00423189|Secondary|Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months|Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy|1 Year|||||||
2814363|NCT00423189|Secondary|OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)|OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months &12 months was not determined due to lack of efficacy.|1 Year|||||||
2814364|NCT00423189|Secondary|Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months|Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.|1 Year|not determined due to lack of efficacy||||||
2814366|NCT00423176|Primary|Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline|A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.|||Percentage of opacification||Standard Deviation|Mean
2814367|NCT00423176|Primary|Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.|The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.|||Units on a scale||Standard Deviation|Mean
2814368|NCT00423150|Primary|Tumor Responses (Complete and Partial Response)|"Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first|"Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).~Complete response is defined as disappearance of all target lesions.~Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|||Participants|||Number
2814369|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)|BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.|||Units on a scale||Standard Deviation|Mean
2814370|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)|SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.|||Units on a scale||Standard Deviation|Mean
2814371|NCT00423098|Secondary|Number of Patients With Treatment Failure|Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.|12 Weeks and 24 Weeks|Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||participants|||Number
2814372|NCT00423098|Secondary|Number of Patients With Adverse Events and Infections|Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||participants|||Number
2814373|NCT00423098|Secondary|Duration of Exposure to Study Medication|The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||days||Standard Deviation|Mean
2814374|NCT00423098|Secondary|Number of Patients With Moderate to Severe Flares|A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)|12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||participants|||Number
2814375|NCT00423098|Secondary|Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)|Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.|12 Weeks and 24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.|||mg/kg||Standard Deviation|Mean
2814605|NCT00421993|Secondary|Percent Change in Noniflammatory Lesion Counts|Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF|||Percent change||Standard Deviation|Mean
2814379|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale|The Modified Crichton Scale includes a total of seven items evaluated in eight grades that assess basic activities of daily living, communication functions, psychiatric symptoms and quality of life; the total score can range from 0 to 56, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814380|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living. The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in activities of daily living while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814381|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. This outcome measured the change in MMSE from the beginning of the open-label extension phase through to Week 52 of the extension phase.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward. This population includes all patients who received at least one dose of open-label study medication and had at least one efficacy assessment on treatment in the open-label extension Phase.|||units on a scale||Standard Deviation|Mean
2814382|NCT00423085|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
2814383|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)|MENFIS was used to assess patient cognitive and psychiatric function, and evaluates core symptoms of dementia including cognitive, motivational and emotional aspects. The total score ranges from 0 to 78. The higher the score, the greater the functional deficit. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
2814384|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|BEHAVE-AD was used to assess patient behavior and psychiatric symptoms. It covers symptoms in seven categories: paranoid and delusional ideation, hallucinations, activity disturbances, diurnal rhythm disturbances, aggressiveness, affective disorders and anxieties, and phobias. Caregivers rate behavioral symptoms on a 0-3 scale. The total score can range from 0 to 66, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
2814385|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.|||units on a scale||Standard Deviation|Mean
2814386|NCT00423085|Primary|Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"The overall clinical rating of change from baseline to week 24 measured by the 7-point CIBIC plus-J scale. The Clinician's Interview-Based Impression of Change plus Caregiver Input consists of 3 subscales: Disability Assessment of Dementia Scale, Behavioral Pathology in Alzheimer's Disease Rating Scale and Mental Function Impairment Scale, as well as the Clinician's Global Impression of Change (CGIC). Participants are scored according to the following:~Markedly improved~Moderately improved~Minimally improved~Unchanged~Minimally worse~Moderately worse~Markedly worse"|Baseline and Week 24|Intent-to-treat population utilizing LOCF.|||Participants|||Number
2814387|NCT00423085|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline and Week 24|The Intent-to-treat population: This population includes all randomized patients who received at least one dose of study drug and had at least a baseline and any post-baseline assessment on treatment (i.e. not more than 2 days after the last known date of study drug) for one of the primary efficacy variables. LOCF was utilized.|||units on a scale||Standard Deviation|Mean
2814388|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAE(s) was not assessed.~Note: SAEs were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814389|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814390|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814391|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814392|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814393|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814394|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814395|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|"NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Note: NOCD and MSC cases were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814396|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814397|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814398|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814399|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814400|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814401|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814402|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination.|During the 30-day period (Day 0-29) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814403|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814404|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.|||Participants|||Count of Participants
2814405|NCT00423046|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||Up to Month 7|The number of subjects completing the 3-dose vaccination schedule was defined as the number of subjects who received the 3 active doses (placebo administrations are not reflected).|||Participants|||Count of Participants
2814406|NCT00423046|Secondary|Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7, 12, 18, 24, 36 and 48|Analyses were done on those subjects from the ATP cohort for immunogenicity for whom CVS samples with less than 200 erythrocytes per microliter were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2814407|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells|HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group in subjects with detectable B-cells (>0) at defined time points, who were HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific B-cell negative at baseline from a subset of the ATP cohort for immunogenicity.|||cells per million B-cells||Full Range|Geometric Mean
2814408|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells|"Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells.~Analyses for further time points were not performed, as there was no response at these time points."|At Month 7, 12 and 18|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 200 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.|||cells per million CD8 T-cells||Full Range|Geometric Mean
2814453|NCT00422734|Secondary|"Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response"|"Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable|||percentage of partners answering Yes|||Number
2814409|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells|Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 500 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.|||cells per million CD4 T-cells||Full Range|Geometric Mean
2814410|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2814411|NCT00423046|Secondary|Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination.|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||Participants|||Count of Participants
2814412|NCT00423046|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2814413|NCT00423046|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.|||Participants|||Count of Participants
2814414|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value|The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||Participants|||Count of Participants
2814415|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay|Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity with titer greater than or equal to 40 ED50 and who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||titer||95% Confidence Interval|Geometric Mean
2814416|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value|Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45.|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||Participants|||Count of Participants
2814417|NCT00423046|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|"Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.~Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure."|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||Titer||95% Confidence Interval|Geometric Mean
2814418|NCT00423046|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Month 7|Analysis was performed on subjects from the According-to-Protocol (ATP) cohort for immunogenicity aged 18 to 26 years and who were seronegative by Pseudovirion (PSV) neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.|||titer||95% Confidence Interval|Geometric Mean
2814419|NCT00422942|Primary|Change From Baseline in Absolute B Cell CD19+ Counts in Peripheral Blood|The change from baseline in absolute B cell (CD19+) count at each visit calculated as (B cell count at visit minus B cell count at baseline) for peripheral blood.|Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814606|NCT00421993|Secondary|Percent Change in Inflammatory Lesion Counts|Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF|||Percent change||Standard Deviation|Mean
2814420|NCT00422942|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score|Changes from baseline in modified Sharp radiographic JSN score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814421|NCT00422942|Secondary|Change From Baseline in Erosion Score|Changes from baseline in modified Sharp radiographic erosion score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814422|NCT00422942|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814423|NCT00422942|Secondary|Change From Baseline in ACR Core Set|The changes from baseline in the ACR core set parameters at Week 48. Change from baseline to Week 48 over time in ACR core set: SJC, TJC, physician's global assessment of disease activity, patient's global assessment of disease activity, patient's assessment of pain, HAQ, ESR, and CRP. ACR20/50/70 response: ≥20%/50%/70% improvement in SJC; ≥20%/50%/70% improvement in TJC; and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; physician's global assessment of disease activity, participant's assessment of disease activity, participant assessment of functional disability via a HAQ, and CRP at each visit.|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814424|NCT00422942|Secondary|Percentage of Participants Achieving Response by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤ 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤ 1.2 with DAS28 ≤ 5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤ 1.2 with DAS28 >5.1.|Weeks 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814425|NCT00422942|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) Score|The change in DAS28-ESR at Weeks 12, 24, 36, and 48, relative to baseline. DAS28-ESR was calculated from SJC and TJC using 28-joint count, ESR (millimeters per hour [mm/hour]) and patient global assessment of disease activity (participant-rated arthritis activity assessment). Total score range: 0-9.4, higher score equals (=) more disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR <2.6 = remission.|Weeks 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814426|NCT00422942|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (20%) 50%, and 70% (ACR20/50/70) Response|ACR20/50/70 response is greater than or equal to (≥) 20%, 50%, or 70% improvement, respectively, in tender joint count (TJC) and swollen joint count (SJC); and improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814427|NCT00422942|Secondary|Change From Baseline in Myelocytomatosis Oncogene (C-myc) and BCL2-associated X Protein (BAX) in Peripheral Blood|The change in ribonucleic acid (RNA) expression of markers of apoptosis (C-myc and BAX) in peripheral blood at Days 15 and 183, relative to baseline.|Days 15 and 183|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814428|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in Synovial Tissues|The change in levels of key cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814429|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines (Interleukin [IL]-1beta [β], Tumor Necrosis Factor [TNF]-Alpha [α], IL-4, IL-6, IL-10, and IL-13) in Blood (Serum)|The change in levels of key cytokines (IL-1β, TNF-α, IL-4, IL-6, IL-10, and IL-13) in blood (serum) on Days 15 and 183 and at Weeks 4, 12, 24, 36, and 48, relative to baseline.|Days 15 and 183 and Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814430|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Peripheral Blood|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in peripheral blood at Weeks 4,12, 24, 36, and 48, relative to baseline.|Weeks 4,12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814431|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Synovial Tissues|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814432|NCT00422942|Primary|Change From Baseline in Absolute B Cell Cluster Differential 19 Positive (CD19+) Counts in Synovial Tissues|The change from baseline in absolute B cell (CD19+) counts at each visit calculated as (B cell count at visit minus B cell count at baseline) for synovial tissues.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.||||||
2814433|NCT00422903|Secondary|Time to Treatment Failure From the Start of the Primary Therapy|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death for any cause.|From Baseline (Day 1) up to study withdrawal (approx. 66 months)|ITT Population. Only those participants contributing data were analyzed.|||Months||95% Confidence Interval|Median
2814434|NCT00422903|Secondary|Mean Left Ventricular Ejection Fraction (LVEF)|Cardiac safety was evaluated as any signs or symptoms of deterioration in LVEF. LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. LVEF was evaluated using NCI CTCAE.|Baseline (Day 1), after 12 weeks, and after 24 weeks|ITT Population. Only those participants contributing data were analyzed.|||Percent volume||Full Range|Mean
2814435|NCT00422903|Secondary|Number of Participants With the Indicated Adverse Events With a Classification of >=Grade 2|Toxicity was measured in grades (severity of the AE) as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening/disabling; Grade 5, death related to the AE. Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, and hypertension is high blood pressure.|From Baseline (Day 1) up to 6 months (until definitive surgery)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
2814436|NCT00422903|Secondary|Percentage of Participants With Conversion From Planned Mastectomy at Baseline to BCS at Surgery|The percentage of participants who were planned to undergo a mastectomy at baseline but later underwent BCS was measured.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.|||percentage of participants|||Number
2814437|NCT00422903|Secondary|Number of Participants With the Indicated Type of Surgery|Mastectomy is the medical term for the surgical removal of one or both breasts. Breast-conserving surgery (BCS) involves removing only the affected part of the breast tissue during surgery, as opposed to removal of the entire breast.|At the point of definitive surgery (up to 6 months after Baseline 1)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
2814438|NCT00422903|Secondary|Number of Participants With the Indicated Nodal Status at Surgery|The nodal status of cancer indicates the involvement of lymph nodes in the participant with cancer. N0 indicates no involvement of lymph nodes, and N+ indicates involvement of lymph nodes.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
2814439|NCT00422903|Secondary|Number of Participants With Breast Tumors Per Pathological Stage at Surgery|Tumors were categorized as follows: T0, no evidence of primary tumor, but carcinoma of the milk ducts, accumulation of abnormal cells in the breast lobules, or Paget disease (cancer condition that appears like a skin disease involving the breast nipple) with no associated tumor mass; T1, tumor was <=2 centimeters (cm) across; T2, tumor was >2 cm but <5 cm across; T3, tumor was >5 cm across; T4, tumor of any size growing into the chest wall or skin, including inflammatory breast cancer.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.|||participants|||Number
2814454|NCT00422734|Secondary|"Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response"|"Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable|||percentage of subjects answering Yes|||Number
2814440|NCT00422903|Secondary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and Axillary Nodes, Evaluated Using Miller and Payne Criteria|pCR is defined as the complete absence of infiltrating tumor cells (TCs) in the breast and lymph nodes. Miller and Payne criteria: Grade 1, no change/some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, up to a 30% loss in TCs; Grade 3, between an estimated 30% and 90% reduction in TCs; Grade 4, more than a 90% reduction in TCs, only small cluster/dispersed cells remaining; Grade 5, no malignant identifiable cells; carcinoma in the milk ducts may be present. Grades 1 and 2 = No response; Grades 3 and 4= PR; Grade 5 = CR.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population|||Percentage of participants||95% Confidence Interval|Number
2814441|NCT00422903|Primary|Percentage of Participants With Various Responses in the Breast, Evaluated Using Per Protocol Criteria|Complete clinical response=nodule not detectable; all ultrasound abnormalities detected at diagnosis have disappeared. Partial clinical response=the tumor's longest diameter (LD) is reduced by 50% or more; ultrasound characteristics of the tumor persist. Minimal response=the tumor's LD is reduced by 25%-49%. Stable disease=the tumor's LD is decreased by less than 25% and is increased by no more than 25% from the starting value. Progressive disease=the tumor's LD is increased by more than 25% from the starting value. Participants who were not evaluable did not have data available.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|ITT Population. Three participants withdrew consent and were not included in the efficacy analysis.|||percentage of participants|||Number
2814442|NCT00422903|Primary|Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee|cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of letrozole. Three participants withdrew consent and were not included in the efficacy analysis.|||percentage of participants|||Number
2814443|NCT00422812|Secondary|Survival of Headache Pain Relief|Survival for time to the first successful headache pain relief by Pain-IHS definition over the 0 to 4 hr period by treatment assigned. Pairwise comparisons were made for each of the 3 active doses to placebo. Survival Analysis (Kaplan-Meyer) was included to evaluate treatment efficacy over the 0 to 4 hr period. All tests were 2-sided with a p-value at α=0.05.|0 to 4 hours|ITT Population|||Participants|||Count of Participants
2814444|NCT00422812|Secondary|Responders, Pain-Free at 2 Hours|Percentage of Responders, Pain-Free, by Treatment Group over Time|2 hours|ITT w/ LOCF Population|||Participants|||Count of Participants
2814445|NCT00422812|Primary|Headache Pain Relief at 2 hr|Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),|2 hr post-dose|ITT w/ LOCF Population|||Participants|||Count of Participants
2814446|NCT00422799|Secondary|Duration of Response in Patients With WM|Time from documentation of first response to progressive disease.|5 Years|All participants enrolled|||years||95% Confidence Interval|Median
2814447|NCT00422799|Secondary|Time to Progression in Patients With WM|Time to progresion is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum monoclonal IgM electrophoresis confirmed by a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease or symptoms attributable to WM.|5 Years|All enrolled participants.|||years||95% Confidence Interval|Median
2814448|NCT00422799|Primary|Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated WM|Overall Response Rate= Minor response (>25%-50% reduction in monoclonal IgM from baseline + Partial Response (>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)|2 years|Participants who were previously untreated.|||Participants|||Count of Participants
2814449|NCT00422799|Primary|Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory WM.|Overall Response Rate= Minor response (>25%-50% reduction in monoclonal IgM from baseline + Partial Response (>50-90% reduction in monoclonal IgM from baseline)+ Complete Response (Disappearance of monoclonal protein by immunofixation; no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. Reconfirmation of the CR status is required at least 6 weeks apart with a second immunofixation.)|2 Years|Patients who had received at least one prior line of therapy|||Participants|||Count of Participants
2814450|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales|Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814451|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814476|NCT00422591|Secondary|Overall Survival (OS)|Overall Survival (OS) was calculated with Kaplan-Meier estimates. OS was calculated from the time of treatment initiation until death.|Until death or loss of follow-up||||Months||Full Range|Median
2814455|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response|The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814456|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response"|"The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of yes responses to the question during the run-in period and postbaseline period, respectively."|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
2814457|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response"|"The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively."|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
2814458|NCT00422734|Primary|"Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3)."|"The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively."|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement|||percent||Standard Error|Least Squares Mean
2814459|NCT00422734|Secondary|Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain|The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).|12 weeks|all randomized participants having post-baseline data measurement on this variable|||units on a scale||Standard Error|Least Squares Mean
2814460|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814461|NCT00422734|Secondary|Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814462|NCT00422734|Primary|Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)|The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814463|NCT00422734|Primary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement|||units on a scale||Standard Error|Least Squares Mean
2814464|NCT00422695|Primary|Spontaneous Pain Intensity|"Pain intensity as measured with Visual Analog Scale during the time of examination.~The subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain."|The time of the examination|Comparison was made between control and HIV+ subjects|||units on a scale (0 to 10)||Standard Deviation|Mean
2814465|NCT00422695|Primary|Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome|"To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.~To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:~To detect the presence of sensory aberrations in the orofacial complex;~To identify which nerve types are involved;~To identify the type of orofacial pain based on both sensory testing and clinical findings.~3.To determine psychological condition and nutrition status in patients with HIV.~4.To find associations between inherited traits and development of neuropathic pain."|Tests were performed during regular clinical visit. The test duration was about an hour|Comparisons of categorical variables were performed with Fischer’s exact test. Trends in ordered categorical variables were tested with the chi square test.|||Participants|||Number
2814607|NCT00421993|Primary|Changes in Noninflammatory Lesion Counts|Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count|from Baseline to week 12|ITT, LOCF|||Lesion count||Full Range|Median
2814466|NCT00422669|Secondary|Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up|Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
2814467|NCT00422669|Secondary|Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up|Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
2814468|NCT00422669|Secondary|The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up|LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
2814469|NCT00422669|Secondary|The Change in Six-minute Hall Walk Distance|The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
2814470|NCT00422669|Secondary|The Change in LVEF From Two Week Visit to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
2814471|NCT00422669|Primary|The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.||||||
2814472|NCT00422656|Secondary|Treatment-Related Grade 3-4 Adverse Event Rate|The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.|Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||90% Confidence Interval|Number
2814473|NCT00422656|Secondary|Progression Free Survival (PFS)|PFS estimated using the Kaplan-Meier method is defined as the time from registration to death from any cause or disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients alive without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.|Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.|The analysis dataset is comprised of all enrolled patients.|||months||90% Confidence Interval|Median
2814474|NCT00422656|Secondary|Time to Progression (TTP)|TTP estimated using the Kaplan-Meier method is defined as the time from registration to disease progression (PD) based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003) Patients without PD are censored at time of last disease assessment. PD: At least 25% increase in serum monoclonal IgM protein by electrophoresis confirmed with a second measurement at least 2 weeks apart, or progression of clinically significant findings due to disease (i.e., anemia, thrombocytopenia, leucopenia, bulky adenopathy/organomegaly) or symptoms (unexplained recurrent fever of at least 38.4oC, drenching night sweats, at least 10% body weight less, or hyperviscosity, neuropathy, symptomatic cryoglobulinemia, or amyloidosis) attributable to WM.|Disease was assessed every cycle for the first 12 months and every 3 months thereafter. Median follow-up time was 19.5 months and range up to 24 months.|The analysis dataset is comprised of all enrolled patients.|||months||90% Confidence Interval|Median
2814475|NCT00422656|Primary|Overall Response (OR) Rate|OR rate is the percentage of patients achieving Complete Response (CR), Partial Response (PR) or Minimal Response (MR) during treatment based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003). CR: Disappearance of serum monoclonal IgM protein (IgM M-protein) by immunofixation; no histologic evidence of bone marrow (BM) involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan); PR: At least 50% reduction of IgM M-protein and at least 50% decrease in adenopathy/organomegaly on physical examination or on CT scan; and MR: At least 25% but less than 50% reduction of IgM M-protein by protein electrophoresis. Patients must have no new symptoms or signs of active disease.|Disease was assessed every cycle for the first 12 months and every 3 months thereafter. The median duration of treatment with perifosine was 5.6 months (range, 1.8- 21.5+).|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||90% Confidence Interval|Number
2814479|NCT00422513|Secondary|The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants|A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.|Baseline, Month 1 to Month 7|Safety Population|||number of participants|||Number
2814480|NCT00422513|Secondary|Number of Participants Assessed for AEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|Month 1 to 15 day follow up post month 7|Safety Population|||number of participants|||Number
2814481|NCT00422513|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Baseline, Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.|||g/dL|||Number
2814482|NCT00422513|Primary|Time Spent on Anemia Treatment Over Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.|||months|||Number
2814483|NCT00422448|Secondary|Frequency of NRAS Mutations Among Nevi|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.|30 months|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.|||NRAS mutations|Participants||Number
2814484|NCT00422448|Primary|Frequency of BRAF Mutations Among Nevi|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.|up to 30 months|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.|||BRAF mutations|Participants||Number
2814485|NCT00422422|Secondary|Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period||Baseline to the end of the 3-week evaluation period|Although 99 subjects were in the Safety Set and confirmed to have taken at least one dose of BRV, details on study drug intake were not able to be collected for 2 subjects. Therefore compliance could only be calculated for 97 subjects.|||participants|||Number
2814486|NCT00422422|Secondary|Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period||||participants|||Number
2814487|NCT00422422|Secondary|Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period||||participants|||Number
2814488|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥12 to <16 Years||Day 21||||ug/mL||Full Range|Mean
2814489|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥2 to <12 Years||Day 21||||ug/mL||Full Range|Mean
2814490|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years||Day 21||||ug/mL||Full Range|Mean
2814491|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years||Day 21||||ug/mL||Standard Deviation|Mean
2814492|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years||Day 21||||ug/mL||Standard Deviation|Mean
2814493|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years||Day 21||||ug/mL||Standard Deviation|Mean
2814494|NCT00422383|Secondary|Percentage of Participants With Positive Recall Antigen Antibody Titers|A positive titer result to recall antigens was defined as a serum antibody level equal to or above the following protective levels: tetanus toxoid ≥ 0.1 IU/mL, influenza A > 12 U/mL, influenza B > 12 U/mL, and streptococcus (S.) pneumococcus ≥ 1.0 mg/L.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2814495|NCT00422383|Secondary|Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers|ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2814496|NCT00422383|Secondary|Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers|"A participant was defined as being HACA positive if the HACA serum level was ≥ 5 relative units (RU) per mL and the physician comment read that participant was immunodepletable with rituximab."|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2814497|NCT00422383|Secondary|Change From BL in Activated Complement Component 4a (C4a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
2814498|NCT00422383|Secondary|Change From BL in Complement C4 Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint|||g/L||Standard Deviation|Mean
2814608|NCT00421993|Primary|Changes in Inflammatory Lesion Counts|Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts|from Baseline to week 12|ITT, LOCF|||Lesion count||Full Range|Median
2814505|NCT00422383|Secondary|Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative|Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF ≥ 20 international units (IU) per mL. RF seronegative status was defined as RF < 20 IU/mL.|BL, Weeks 8, 24, and 48|RF seropositive participants from the ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2814506|NCT00422383|Secondary|Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN|The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.|BL, Weeks 24 and 48|ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2814507|NCT00422383|Secondary|Change From BL in Peripheral CD16+56+ Cell Count|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814508|NCT00422383|Secondary|Peripheral CD16+56+ Natural Killer (NK) Cell Count in Cells/µL|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814509|NCT00422383|Secondary|Change From BL in Peripheral CD8+ Cell Count|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814510|NCT00422383|Secondary|Peripheral CD8+ T Cell Count in Cells/µL|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814511|NCT00422383|Secondary|Change From BL in Peripheral CD4+ T Cell Count|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814512|NCT00422383|Secondary|Peripheral CD4+ T Cell Count in Cells/µL|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814513|NCT00422383|Secondary|Change From BL in Peripheral CD3+ T Cell Count|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814514|NCT00422383|Secondary|Peripheral CD3+ T Cell Count in Cells/µL|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814515|NCT00422383|Secondary|Peripheral CD19+CD27 Negative (-) B Cell Count in Cells/µL|Surface expression of CD19 in the absence of CD27 expression was assessed by FACS analysis as a marker of naive B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814516|NCT00422383|Secondary|Peripheral CD19+CD27+ B Cell Count in Cells/µL|Simultaneous surface expression of CD19 and CD27 was assessed by FACS analysis as a marker of memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814517|NCT00422383|Secondary|Peripheral CD22+ B Cell Count in Cells/µL|Surface expression of CD22 was assessed by FACS analysis as a marker of mature lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814518|NCT00422383|Secondary|Peripheral CD20+ B Cell Count in Cells/µL|Surface expression of CD20 was assessed by FACS analysis as a marker of mature and memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|The safety analysis population (SAP) = ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||cells/µL||Standard Deviation|Mean
2814519|NCT00422383|Secondary|Percentage of Participants With Peripheral CD19+ B Cell Counts Above BL or the Lower Limit of Normal (LLN)|Surface expression of CD19 was assessed by FACS analysis as a marker of absolute B lymphocyte count. The LLN was defined as < 80 cells/µL.|BL, Days 1 and 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||percentage of participants|||Number
2814520|NCT00422383|Secondary|Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)|Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.|BL|ITT-M2 population. 7, 8, 3, 1, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, High Dose, Placebo, and Decreased Dose groups, respectively.|||cells/µL||Standard Deviation|Mean
2814521|NCT00422383|Secondary|Terminal Elimination Half-Life (t1/2) in the 1st and 2nd Courses of Treatment in Days|t1/2 values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||days||Standard Deviation|Mean
2814522|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL|Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.|||µg/mL||Standard Deviation|Mean
2814523|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 1st Infusion of Rituximab (Cfirst) in the 1st and 2nd Courses of Treatment in Micrograms Per mL (µg/mL)|Cfirst values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.|||µg/mL||Standard Deviation|Mean
2814524|NCT00422383|Secondary|Change in SF-36 Score From BL|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Weeks 24 and 48|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
2814525|NCT00422383|Secondary|Short-Form 36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Week (Wk) 24 and 48|ITT-M2 population, n (number) = number of participants analyzed for the given parameter at the specified timepoint.|||score on a scale||Standard Deviation|Mean
2814526|NCT00422383|Secondary|Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score From BL at Week 48|"FACIT-F scores were obtained from a 13 question self-administered participant questionnaire designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants responded to the questions using a value between 0 and 4, where 0 indicated not at all and 4 indicated very much. 11 of the 13 questions were negatively stated; indicating the higher the score of the participant's response, the greater their fatigue. These questions were calculated as 4 minus the participants' response, so that a higher score indicated an improvement in health. The scores for the 2 positively stated questions were not changed. The participants' responses were summed to result in an overall score, which are scored 0 to 52 (52 = highest level of functioning). A positive change from BL indicated improvement."|BL, Week 48|ITT-M2 population. 9, 4, 2, and 1 participants were not evaluated for this outcome measure from the Low Dose, Escalated Dose, High Dose, and Decreased Dose groups, respectively.|||score on a scale||Standard Deviation|Mean
2814527|NCT00422383|Secondary|Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category|EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR ≤ 3.2 at Week 48 and a change from BL to Week 48 < -1.2 = good response, DAS28-ESR ≤ 3.2 or greater than (>) 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 = moderate response, DAS28-ESR > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR ≤ 3.2 or > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 ≥ -0.6 = no response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 or ≥ -0.6 = no response.|Week 48|ITT-M2 population|||percentage of participants|||Number
2814528|NCT00422383|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48|DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * participant's global assessment of disease activity (GH)]. DAS28-ESR ≥ 5.1 = high disease activity, DAS28-ESR less than or equal to (≤) 3.2 = low disease activity, DAS28-ESR less than (<) 2.6 = remission.|BL, Week 48|ITT-M2 population. Two participants from the Low Dose group and 1 participant from the Escalated Dose group were not evaluated for this outcome measure.|||score on a scale||95% Confidence Interval|Mean
2814529|NCT00422383|Secondary|Percentage of Participants With a ACR 70% Improvement Criteria (ACR70) Response at Week 48|ACR70 was defined as an overall score of 70 in the ACRn calculation. The Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR70 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population|||percentage of participants|||Number
2814549|NCT00422201|Secondary|Features of Cushing's Syndrome|"Criteria for secondary glycemic disorder improvement of clinical symptoms attributable to the Cushing's syndrome A. For diabetic patients~Improvement of the following parameters: glycemic profile, fasting blood glucose, fructosamine, 2-hour OGTT (for diabetics diagnosed at screening)~Number of anti-diabetics treatment or dose of anti-diabetics treatment for diabetic patients already on diabetes treatment at inclusion~Doses of insulin for insulin-treated patients B. For patients with IGT~HbA1c~Fructosamine C. For patients with IFG~HbA1c~Fructosamine D. For all patients~Fasting plasma insulin~Area Under the Curve of OGTT results when OGTT performed~HOMA index"|8 weeks at steady dose|18 patients were recruited. 7 completed the study but only 3 according to the last protocol version, so only these 3 patients were to be analysed|||participants|||Number
2814530|NCT00422383|Secondary|Percentage of Participants With ACR 50% Improvement Criteria (ACR50) Response at Week 48|ACR50 was defined as an overall score of 50 in the ACRn calculation. Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR50 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population|||percentage of participants|||Number
2814531|NCT00422383|Primary|Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)|ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (visual analog assessment [VAS]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing|Week 48|ITT-M2 population|||percentage of participants||95% Confidence Interval|Number
2814532|NCT00422292|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age||Days 0 to 7 after vaccination|Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.|||Percentage of Participants|||Number
2814533|NCT00422292|Other Pre-specified|Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age|"Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.~Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability."|Days 0 to 7 after vaccination||||Percentage of Participants|||Number
2814534|NCT00422292|Other Pre-specified|Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4||Day 30 after 12-month vaccination||||Percentage of Participants|||Number
2814535|NCT00422292|Primary|Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4||Day 30 after the 12-month vaccination|Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.|||Titers||95% Confidence Interval|Geometric Mean
2814536|NCT00422292|Primary|Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)|Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.|Day 30 after the 12-month vaccination|Antibody responses were evaluated in the per-protocol population.|||Percentage of Participants|||Number
2814537|NCT00422279|Primary|Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading|The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench|Implant insertion, 3 months, 6 months|Implant stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed|||implants|Participants||Number
2814538|NCT00422279|Secondary|Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)|"The secondary endpoint of the study was to assess the minimum dose of rhBMP2 eliciting bone growth.The secondary endpoint was assessed by measuring using a probe the quantity of any newly formed bone 1.in the group where implants were placed in the supra alveolar position the treatment is successful if the bone exceeds 1.5 mm above the initial alveolar bone level in all measured points 1. in the group where implants were placed in extraction sockets the treatment is successful if the gap between the implant body and the extraction socket is filled with Bone.~Safety dose used:- In the dog model; seroma formation was extensive with higher rhBMP-2 concentrations (3.0 and 4.0 mg/mL.Seromas was also significant in the dog model for the 0.75 and 1.5 mg/mL rhBMP-2 concentrations, hence a minimum dose of 15 and 30 µg per implants was chosen)"|3 months|1.When implants were placed in the supraalveolar position the treatment was not successful 2. in the group where implants were placed in extraction sockets the treatment was not successful|||Number of participants with bone grow|||Number
2814539|NCT00422227|Secondary|Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales|"VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, in general how would you rate your heath over the last 2-3 weeks, 0mm equals very well and 100mm equals extremely bad. Pain VAS: indicate the amount of pain experienced during the last 2-3 days, 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: how fatigued or tired have you been over the last week, range =No Fatigue - Extremely Fatigued."|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
2814540|NCT00422227|Secondary|Percent Change From Baseline in Duration (Minutes) of Morning Stiffness|The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
2814541|NCT00422227|Secondary|Percent Change From Baseline in Physician And Subject Global Assessments|The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
2814542|NCT00422227|Secondary|Percent Change From Baseline in Painful and Swollen Joint Counts|Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
2814543|NCT00422227|Secondary|Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
2814544|NCT00422227|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response|EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
2814545|NCT00422227|Secondary|Percent Change From Baseline in DAS28 at Week 16|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percent change|||Number
2814546|NCT00422227|Secondary|Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
2814547|NCT00422227|Secondary|Percentage of Participants Achieving ACR 20, 50, and 70 Responses|Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Percentage of Participants|||Number
2814548|NCT00422227|Primary|Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks|"ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.~The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks."|16 weeks|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.|||Units on a scale||Standard Error|Mean
2814584|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 20|Calculated as mean blood pressure at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmHg||Standard Deviation|Mean
2814550|NCT00422201|Primary|Glycemic Disorders Improved or Normalized|"Criteria for improvement or normalization of glycemic disorders:~A. For diabetic patients (known or diagnosed at pre-inclusion visit)~Decrease in HbA1c > 0.3% B. For patients with IGT~Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG~If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion:~- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL)~If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0):~- Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)"|8 weeks at steady dose|18 patients were recruited. 7 completed the study but only 3 according to the last protocol version (in which primary efficacy criteria were changed), so only these 3 patients were to be analysed|||participants|||Number
2814551|NCT00422162|Secondary|Change From Baseline to Week 4 and Week 8 in Weight|Change in weight = Post-baseline visit minus baseline.|Baseline to Weeks 4 and 8|All randomized participants with at least one dose of study drug and a baseline and at least one post-baseline value. Last observation carried forward.|||kilograms||Standard Deviation|Mean
2814552|NCT00422162|Secondary|Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study|Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline.|over 8 weeks|All randomized participants with at least one dose of study drug.|||participants|||Number
2814553|NCT00422162|Secondary|Discontinuations Due to Adverse Events (AE)|Listing of adverse events (AE) that led to treatment discontinuation (DC).|over 8 weeks|All randomized participants with at least one dose of study drug.|||participants|||Number
2814554|NCT00422162|Secondary|Number of Patients With Potentially Clinically Significant Laboratory Findings|Laboratory results that were potentially clinically significant.|over 8 weeks|All randomized participants with at least one dose of study drug.|||participants|||Number
2814555|NCT00422162|Secondary|Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication|Number of participants using medication for anxiety and sleep disturbances.|over 8 weeks|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. The total number of patients with hypnotics and anxiolytics concomitant therapies was 125 (Duloxetine 60mg) and 123 (Duloxetine 120mg).|||participants|||Number
2814556|NCT00422162|Secondary|Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8|"The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is not at all important and 6 is extremely important. The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6."|Baseline and Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
2814557|NCT00422162|Secondary|Patients Reaching Remission|Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.|Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||participants|||Number
2814558|NCT00422162|Secondary|Percentage of Responders|Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks.|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||percentage of participants|||Number
2814559|NCT00422162|Secondary|Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and Weeks 4 and 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814560|NCT00422162|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Each Visit|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814561|NCT00422162|Secondary|Clinical Global Impression of Improvement (CGI-I) at Each Visit|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814562|NCT00422162|Secondary|Clinical Global Impression of Severity (CGI-S) Scores at Each Visit|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814609|NCT00421993|Primary|Success Rate on the Investigator's Global Assessment|"Percentage of subjects rated Clear and Almost Clear on 5-point scale (0=clear; 4=severe)"|at week 12|Intention to treat (ITT), last observation carried forward (LOCF).|||Percentage of participants|||Number
2814563|NCT00422162|Secondary|Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)|"Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe)."|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had a Week 4 and at least one following value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
2814564|NCT00422162|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
2814565|NCT00422162|Secondary|Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline|"The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe)."|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.|||units on a scale||Standard Deviation|Mean
2814566|NCT00422162|Primary|Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 4|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2814567|NCT00422097|Secondary|Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels|Upper limit of normal (ULN)=upper level of normal among all laboratory ranges. Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN; Gr 4: >20.0*ULN. Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120. Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0; Gr 4: <2.5 or >7.0. Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5; Gr 4: <6.0 or >13.5. Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0; Gr 4: <1.0. Albumin (g/dL): Gr 3: <2.0.|At screening and predose Day 1, Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.|||Participants|||Number
2814568|NCT00422097|Secondary|Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)|Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength. Participants also underwent a 12-lead ECG screening. Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.|At screening and predose Day 1, Cycle 1 (21 days)|Although physical examinations and ECGs were performed, the findings were not summarized.|||Participants|||Number
2814569|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.|||ng*h/mL||Standard Deviation|Mean
2814570|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.|||ng/mL||Full Range|Median
2814571|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.|||ng/mL||Standard Deviation|Mean
2814610|NCT00421954|Primary|Weight Gain and Other Side Effects||couple of months|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2814572|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).|||ng*h/mL||Standard Deviation|Mean
2814573|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).|||ng/mL||Full Range|Median
2814574|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine (Cycle 2).|||ng/mL||Standard Deviation|Mean
2814575|NCT00422097|Secondary|Plasma Half-life (T-Half) of Ixabepilone||Day 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles|||Hours||Standard Deviation|Mean
2814576|NCT00422097|Secondary|Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles.|||ng*h/mL||Standard Deviation|Mean
2814577|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles|||Hour||Full Range|Median
2814578|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles|||ng/mL||Standard Deviation|Mean
2814579|NCT00422097|Primary|Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade|Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.|Days 1 through 21 (Cycle 1), continuously|All Treated Participants: All participants who received at least one dose of ixabepilone were included.|||Participants|||Number
2814580|NCT00422097|Secondary|Number of Participants With Abnormal Laboratory Values by Worst CTC Grade|Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges. Hemoglobin (g/dL): Gr 1: 10.0-<LLN; Gr 2: 8.0-<10.0; Gr 3:6.5-<8.0; Gr 4: 6.5. Leukocytes (c/uL): Gr 1: 3.0-<LLN; Gr 2: 2.0-<3.0; Gr 3: 1.0-<2.0; Gr 4: <1.0. Lymphocytes (c/uL): Gr 1: 0.8-<1.5; Gr 2: 0.5-<0.8; Gr 3: 0.2-<0.5; Gr 4: <0.2. Neutrophils (Absolute)(c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Neutrophils + Bands (c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Platelet Count (c/uL):Gr 1: 75.0-<LLN; Gr 2: 50.0-<75.0; Gr 3: 25.0-<50.0; Gr 4: <25.0.|Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.|||Participants|||Number
2814581|NCT00422097|Primary|Maximum Tolerated Dose (MTD) of Ixabepilone|MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.|Days 1 through 21 (Cycle 1)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.|||mg/d|||Number
2814582|NCT00422097|Secondary|Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21 (Cycle 1), continuously|All Treated Subjects: All subjects who received at least 1 dose of ixabepilone.|||Participants|||Number
2814583|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 104|Calculated as mean blood pressure at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmHg||Standard Deviation|Mean
2824862|NCT00346151|Secondary|Proportion of Participants With Malignancies||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2814587|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 104|Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mcg/mL||Standard Deviation|Mean
2814588|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 20|Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mcg/mL||Standard Deviation|Mean
2814589|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 104|Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||g/L||Standard Deviation|Mean
2814590|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 20|Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||g/L||Standard Deviation|Mean
2814591|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||U/mL||Standard Deviation|Mean
2814592|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||U/mL||Standard Deviation|Mean
2814593|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mg/L||Standard Deviation|Mean
2814594|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||mg/L||Standard Deviation|Mean
2814595|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||percentage (%) of total haemoglobin||Standard Deviation|Mean
2814596|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||percentage (%) of total haemoglobin||Standard Deviation|Mean
2814597|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 104|Calculated as mean fasting insulin at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||pmol/L||Standard Deviation|Mean
2814598|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 20|Calculated as mean fasting insulin at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).|||pmol/L||Standard Deviation|Mean
2814599|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 104|Calculated as mean fasting plasma glucose at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmol/L||Standard Deviation|Mean
2814600|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 20|Calculated as mean fasting plasma glucose at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product|||mmol/L||Standard Deviation|Mean
2814601|NCT00422058|Secondary|Mean Change From Baseline in Body Weight at Week 104|Calculated as mean body weight at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.|||kg||Standard Deviation|Mean
2814602|NCT00422058|Primary|Mean Change From Baseline in Body Weight at Week 20|Calculated as mean body weight at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.|||kg||Standard Deviation|Mean
2814603|NCT00422032|Primary|Number of Participants With Response for Two Dose Schedules of Clofarabine|Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts </=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to >/= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).|4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)||||Participants|||Number
2814604|NCT00421993|Secondary|Percent Change in Total Lesion Counts|Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF|||Percent change||Standard Deviation|Mean
2824863|NCT00346151|Secondary|Proportion of Participants With Wound Complications||Start of study to end of study|Intent to Treat Sample|||Participants|||Number
2814611|NCT00421928|Secondary|Change From Baseline in Responder Analysis 50% Improvement to Week 12|"Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|ITT. Subjects who discontinued from the study were considered non-responders.|||Percentage of participants|||Number
2814612|NCT00421928|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead"|Baseline and 12 week endpoint|ITT|||scores on a scale||Standard Deviation|Mean
2814613|NCT00421928|Secondary|Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint|Baseline to 12 weeks|ITT: The results for median and interquartile ranges were not estimable because insufficient number of subjects discontinued due to lack of efficacy to estimate the values.|||median time|||Number
2814614|NCT00421928|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|Baseline and 12 week endpoint|ITT|||percentage of participants|||Number
2814615|NCT00421928|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionniare addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|ITT|||Hours||Standard Deviation|Mean
2814616|NCT00421928|Secondary|Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability|Baseline and 12 week endpoint|Intent To Treat (ITT), observed cases analysis conducted, no imputation performed.|||Scores on a scale||Standard Deviation|Mean
2814617|NCT00421928|Primary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation|||Scores on a scale||Standard Deviation|Mean
2814618|NCT00421889|Primary|Dose Limiting Toxicities (DLT), Part A|To determine the number of participants experiencing dose limiting toxicities of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin and paclitaxel or both.|Cycle 1||||participants|||Number
2814619|NCT00421889|Secondary|Belinostat AUC (0-infinity)||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.|||ng*h/mL||Standard Deviation|Mean
2814620|NCT00421889|Secondary|Belinostat Mean t½||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters|||hours||Standard Deviation|Mean
2814621|NCT00421889|Secondary|Belinostat Cmax||Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 41 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2814622|NCT00421889|Secondary|Duration of Response|Defined as interval from the time criteria for CR or PR are met, until the first date that recurrent or progressive disease is objectively documented.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.|||days||Full Range|Median
2814623|NCT00421889|Secondary|Time to Response|Time to response (RECIST) was assessed as the interval between the first dates of treatment until the first notation of response.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.|||days||Full Range|Median
2814624|NCT00421889|Secondary|Time to Progression|Time to progression, defined as the interval between the first dates of treatment until the first notation of disease progression. RECIST criteria|Throughout study|Per protocol Population, includes all patients who have received at least two cycles (complete treatment days, dose reductions per protocol allowed) of study treatment and who have also had at least one post-baseline tumor assessment. Not done for Part A.|||days||95% Confidence Interval|Median
2814625|NCT00421889|Secondary|To Determine the Pharmacodynamic Effects of Belinostat (in the Combination) on Histone Acetylation in Peripheral Blood Mononuclear Cells (Selected Sites)||Throughout the study|Histone acetylase analysis was planned, but not successful due to technical issues with the method.||||||
2814665|NCT00421174|Secondary|Response to Therapy|Response will be defined as the ability to survive to Day 56 of study, plus the ability to completely discontinue all supplemental oxygen support for > 72 consecutive hours during this time period.|Day 56||||percentage of participants||95% Confidence Interval|Number
2814626|NCT00421889|Secondary|Best Overall Response (CR or PR)|Best overall responses were assessed by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Clinical tumor evaluation will take place after each cycle. Formal radiological evaluation after every 2 cycles. If a response is noted, a follow-up radiographic assessment must be performed 4 weeks (+ 1 week) after the response is noted|Throughout study until PD (progressive disease) or lost to follow up|Primary efficacy analysis population, includes all patients who have been enrolled into the study and received at least one dose of study medication.|||participants|||Number
2814627|NCT00421889|Primary|Maximum Tolerable Dose (MTD) Belinostat, Part A,|To determine the maximum tolerated dose of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin (AUC of 5) and paclitaxel (175 mg/m2).|Cycle 1||||mg/m2|||Number
2814628|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.|Change is mean change in picograms of iPTH per milliliter of serum.|Baseline (screening period) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.|||picogram/milliliter||Standard Deviation|Mean
2814629|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.|The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.|||log milligrams of albumin per 24 hours||Standard Deviation|Mean
2814630|NCT00421733|Secondary|Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.|Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.|||Participants|||Number
2814631|NCT00421733|Primary|Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).|UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.|||log milligram/gram creatinine||Standard Deviation|Mean
2814632|NCT00421707|Secondary|Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD)|HAD Scale was used to assess the severity of symptoms of anxiety and depression in participants. There were 14 questions. Seven questions related to depression and seven questions related to anxiety. Participants rated the severity of symptoms in the answer to each question. There were four options in each answer, from which participants had to select one. Responses were scored on a scale of 0, 1, 2 or 3, where 0 indicated best and 3 indicated worse. Total score ranged from 0-42 where 0 indicated absence of symptoms and higher scores indicated higher anxiety/depression complains. This questionnaire was completed at screening, and all study visits.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm.|||Score on a scale||Standard Deviation|Mean
2814633|NCT00421707|Secondary|Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment|"The PHQ-15 comprised of 15 somatic symptoms from the PHQ, each symptom scored from 0 to 2, where 0 (Not bothered at all), 1 (Bothered a little) 2 (bothered a lot). This questionnaire was completed at screening, and all study visits. Total score range was 0-30, where 0 indicated Not bothered at all and 30 indicated bothered a lot. Higher score indicated greater severity of somatization symptoms."|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2814634|NCT00421707|Secondary|IBS Composite Symptom Score|Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|||||||
2814635|NCT00421707|Secondary|Plasma Concentrations of GW876008 at Week 3 and 6|For Week 3, 6, 9, 12, and 15 visits blood samples were collected at: pre-dose (after the pre ECG measurement and just before am dose) and immediately following the 1-3 hour post-dose ECG measurement and concentration of GW876008 was analyzed. Data for Week 3 and 6 was presented.|Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement|Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed was included. Only those participants available at the specified time points were analyzed.|||ng/mL||Standard Deviation|Mean
2814666|NCT00421174|Primary|Response Rate|Response will be defined as survival to Day 28 of study, plus discontinuation of all supplemental oxygen support for more than 72 consecutive hours by Day 28.|Day 28||||percentage of participants||95% Confidence Interval|Number
2822085|NCT00369278|Secondary|"Time to Event for the Composite Endpoint as Well as All Individual Components of That Endpoint Treatment Failure Including Clinical Rejections"|Due to a small number of events, median time to <event> was not reached.|6 months|||||||
2814636|NCT00421707|Secondary|Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function|"The GIS comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse. Number of participants who showed improvement and changes on the scale were presented. Participants were counted as Yes if they scored 1-3, and as No if they scored 4-7."|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population.|||Participants|||Count of Participants
2814637|NCT00421707|Secondary|Percentages of Pain-free Days|Abdominal pain free days are those days where the participant reported a score of '0' for abdominal pain at its worst. Abdominal Pain (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm.|||Percentage of days||Standard Deviation|Mean
2814638|NCT00421707|Secondary|Change From Baseline in Pain Severity Scores|Pain severity scores from the 11-point scale and it's corresponding change from Baseline scores was summarized by treatment group for the last 4 weeks (i.e. weeks 3-6 and Weeks 12-15) of treatment period. Scale from 0 to 10, 0 meaning no pain, 10 worst possible pain. Lower values represent a better outcome. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting baseline value from specified time point value. Reported data values are lesser than minimum score on scale as change from Baseline is reported.|Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2814639|NCT00421707|Secondary|Number of Participants With Improvements in Pain and Discomfort|Number of participants with improvements in pain and discomfort on GIS were presented. GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse on specified time points. Responder = Yes if A responder answered either 'moderately improved' or 'substantially improved'.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2814640|NCT00421707|Primary|Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale|The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2814641|NCT00421707|Primary|Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen|The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.|Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)|Intent to Treat population. Only those participants available at the specified time points were analyzed.|||Proportion of participants responded||Standard Deviation|Mean
2814642|NCT00421707|Primary|Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2|For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.|Up to Day 105|Intent to Treat population||||||
2814643|NCT00421707|Primary|Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).|For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.|Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).|Intent to Treat population.||||||
2814644|NCT00421707|Primary|Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).|For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.|Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)|Intent to Treat population comprised of all participants who were randomized to treatment, who received at least one dose of double blind medication and for whom at least one valid post baseline efficacy assessment was available.||||||
2814675|NCT00420927|Secondary|Change From Baseline in SDAI Score at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Baseline to Week 78||||Scores on a scale||Standard Deviation|Mean
2814645|NCT00421603|Primary|Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back|Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period by the Time Line Follow Back. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.|3 weeks of abstinence during 14 weeks of trial or for length of participation||||participants|||Number
2814646|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 18 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.|||mg/cm^3||Standard Error|Least Squares Mean
2814647|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 0 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.|||mg/cm^3||Standard Error|Least Squares Mean
2814648|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 18 months|All participants were analyzed using the mixed models method.|||g/cm^2||Standard Error|Least Squares Mean
2814649|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 9 months|All participants were analyzed using the mixed models method.|||g/cm^2||Standard Error|Least Squares Mean
2814650|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 0 months|All participants were analyzed using the mixed models method.|||g/cm^2||Standard Error|Least Squares Mean
2814651|NCT00421408|Primary|Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis. Only half of the study partipants were randomized to receive Quantitative Computed Tomography testing.|||percent change||Standard Error|Mean
2814652|NCT00421408|Primary|Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis.|||percentage change||Standard Error|Mean
2814653|NCT00421343|Secondary|Reasons for Non-willingness to Particiapte and Non-adherence With Intervention|We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.|6 months|||||||
2814654|NCT00421343|Primary|Number Adherent With the Intervention||6 months||||participants|||Number
2814655|NCT00421174|Secondary|Pro-inflammatory Markers of Pulmonary Disease, in Both BAL Fluid and Plasma||Day 28|No data collected||||||
2814656|NCT00421174|Secondary|Dermatologic Reaction||Day 28|No data collected||||||
2814657|NCT00421174|Secondary|Overall Mortality||Year 2||||participants|||Number
2814658|NCT00421174|Secondary|Incidence of Relapse|Percentage of patients who experience relapse. Deaths without relapse are considered as a competing risk.|Year 1||||Participants|||Count of Participants
2814659|NCT00421174|Secondary|Incidence of Graft-vs-Host-Disease (GVHD)||Year 1||||percentage of participants||95% Confidence Interval|Number
2814660|NCT00421174|Secondary|Incidence of Toxicity||Day 56||||Toxcities|Total number of toxicities||Number
2814661|NCT00421174|Secondary|Incidence of Infection||Day 56||||Infections|Total number of infections||Number
2814662|NCT00421174|Secondary|Overall Survival|Percentage of patients that survived after one year|Year 1||||percentage of participants||95% Confidence Interval|Number
2814663|NCT00421174|Secondary|Corticosteroid Dose|Patients were treated with systemic corticosteroids with methylprednisolone at 2 mg/kg/day on day 0, with taper allowed after day 7.|Day 14 and 28||||mg/kg/day||Full Range|Median
2814664|NCT00421174|Secondary|Discontinuation of Supplemental Oxygen|"The time required to discontinue supplemental oxygen will be measured in the number of days from study entry."|Day 56||||days||Full Range|Median
2814667|NCT00421148|Secondary|Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration)|The PP population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) & had ≥1 post-baseline efficacy measurement for this outcome measure & had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.|||Minutes||Standard Deviation|Mean
2814668|NCT00421148|Secondary|Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration)|The PP population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) & had ≥1 post-baseline efficacy measurement for this outcome measure & had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.|||Minutes||Standard Deviation|Mean
2814669|NCT00421148|Primary|Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (heights) of the first & fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)|The Per Protocol (PP) population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) & had ≥1 post-baseline efficacy measurement for this outcome measure & had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.|||Minutes||Standard Deviation|Mean
2814670|NCT00420992|Primary|Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)|Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.|randomization to 12 weeks following randomization|intent to treat (ITT)|||units on scale||Standard Deviation|Mean
2814671|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.|Week 78||||Participants|||Number
2814672|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.|Week 78||||Participants|||Number
2814673|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78||||Participants|||Number
2814674|NCT00420927|Secondary|Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78|Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.|Baseline to Week 78|The analysis is based on the Primary Analysis Set, a subset of the ITT Analysis Set that includes subjects who participated in the 78-week HF MRI substudy and whose Baseline HF MRI data were collected on or before the first study drug dose. Observed scores are used in the analysis.|||Scores on a scale||Standard Deviation|Mean
2815189|NCT00418262|Primary|Pittsburg Side-Effects Scale: Worried/Anxious|"Worried/Anxious~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject from RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
2814676|NCT00420927|Secondary|Change From Baseline in CDAI Score at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Baseline to Week 78||||Scores on a scale||Standard Deviation|Mean
2814677|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
2814678|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
2814679|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
2814680|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78||||Participants|||Number
2814681|NCT00420927|Secondary|Change From Baseline in DAS28 Score at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Baseline to Week 78||||Scores on a scale||Standard Deviation|Mean
2814682|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
2814683|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
2814684|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78|Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
2814685|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78|For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
2814686|NCT00420927|Secondary|Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, nonresponder imputation|||Participants|||Number
2814687|NCT00420927|Secondary|Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, Nonresponder imputation|||Participants|||Number
2815190|NCT00418262|Primary|Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers|"Movements, Picking/Chewing Skin or Fingers~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|27 IN PCT and one subject did not enroll in the safety efficacy study|||units on a scale||Standard Deviation|Mean
2814688|NCT00420927|Secondary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78||||Participants|||Number
2814689|NCT00420927|Primary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|The analysis was performed on the ITT Population comprised of all subjects who entered Period 2 and received at least 1 dose of study drug (blinded or open-label) during Period 2. Nonresponder imputation was used for missing data.|||Participants|||Number
2814690|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814691|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814692|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814693|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814694|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814695|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814696|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814718|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|Full Analysis Set = subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
2814697|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814698|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814699|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814700|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814701|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814702|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814703|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814704|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814705|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814706|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814707|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814708|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2814709|NCT00420849|Secondary|Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population|||weeks||Standard Deviation|Mean
2814710|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Venous Thromboembolic Events|Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population|||participants|||Number
2814711|NCT00420849|Secondary|Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population|||weeks||Standard Deviation|Mean
2814712|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Peripheral Neuropathy|Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population|||participants|||Number
2814713|NCT00420849|Primary|Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 123 weeks|Safety population|||participants|||Number
2814714|NCT00420784|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Week 2, 4, 8, 12, 16, 24|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2814715|NCT00420784|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
2814716|NCT00420784|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to 2 weeks after last dose of study drug (up to Week 50)|Full Analysis Set = subjects who received at least 1 dose of study drug.|||participants|||Number
2814717|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA|"Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week and at 48 weeks after last dose of study drug for treatment groups Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL)."|Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)|Full Analysis Set = subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
2815191|NCT00418262|Primary|Pittsburg Side-Effects Scale-Buccal, Lingual Movements|"Buccal, Lingual Movements~Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation."|12 months or study duration|Attrition|||units on a scale||Standard Deviation|Mean
2814719|NCT00420784|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|Full Analysis Set = subjects who received at least 1 dose of study drug|||percentage of participants|||Number
2814720|NCT00420771|Primary|Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back|Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back|data collected during 8 weeks of trial or length of participation|a total of 16 participants had data available post randomization|||milligrams/day||Standard Deviation|Mean
2814721|NCT00420745|Secondary|Serum Anti-Rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort. The anti-rotavirus IgA antibody GMC for Placebo Group was below the assay cut-off (<20 U/mL), so could not be computed.|||U/mL||95% Confidence Interval|Geometric Mean
2814722|NCT00420745|Secondary|Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort that included all subjects with at least one study vaccine or placebo administered, for whom immunogenicity data were collected and available and who complied with the inclusion criteria defined in the protocol.|||subjects|||Number
2814723|NCT00420745|Secondary|Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.|Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.|From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.|||subjects|||Number
2814724|NCT00420745|Secondary|Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.|Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting|Within 15 days after each Rotarix vaccine/Placebo dose.|The analyses were performed on the Total vaccinated cohort for the safety and the immunogenicity subset that included all subjects with at least one study vaccine or placebo administered and for whom solicited symptoms were collected.|||subjects|||Number
2814725|NCT00420745|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any Rotarix vaccine/Placebo dose.|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.|||subjects|||Number
2814726|NCT00420745|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.|||subjects|||Number
2814727|NCT00420641|Secondary|Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10|"CSSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behaviour and ideation. For SB scale, participants were scored as non-suicidal (00), preparatory acts or behavior communicating ideation (01), aborted attempt (02), interrupted attempt (03) or actual attempt (04) based on the most severe score (4 being the most severe). On SI scale, participants were scored as non-suicidal (00), wish to be dead (01), non-specific active suicidal thoughts (02), active suicidal ideation with associated thoughts of methods without intent (03), active suicidal ideation with some intent to act on suicidal thoughts without clear plan (04), active suicidal ideation with plan and intent (05), based on the most severe score (5 being the most severe). For both subscales, 0 indicated absence of symptom and higher score indicated greater severity of symptom. Only those scores for which at least one participant was reported are summarized."|Up to Week 10|ITT Population.|||Participants|||Count of Participants
2814728|NCT00420641|Secondary|Percentage of Participants Satisfied With Study Medication at Week 10|"Participants were asked complete the participant Satisfaction with Study Medication question at Week 10 (or early withdrawal). Satisfaction was measured using a single 7-point Likert scale from 1 to 7 where higher scores indicate greater satisfaction with study medication. A score of 1 represents very dissatisfied, whilst a score of 7 represents very satisfied. Participants were categorized as a responder if they are rated either as 6 Satisfied or 7 Very Satisfied. The proportion of responders as percentage of participants based on the participant satisfaction with study medication item was defined as: number of participants with a response of 6 or 7 at the visit divided by number of participants with a satisfaction with study medication assessment at that visit (the sum of responders and non-responders) multiplied by 100."|Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2814764|NCT00420459|Secondary|The Children's Yale-Brown Obsessive Compulsive Scale|The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
2822086|NCT00369278|Secondary|Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180|Due to a small number of events, median time to <event> was not reached.|6 months|||||||
2814729|NCT00420641|Secondary|Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10|The CGI-I scale measures the improvement of psychiatric symptoms on a 7-point scale from 1-7. The scale was rated by the clinician at every visit during the treatment phase (Week 1 through Week 10/early withdrawal) of the participant's total improvement or worsening compared with that individual's condition at the start of the study (the Randomization visit , Week 0) whether or not the change is judged to be due to drug treatment. The scores indicated the following: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse. The score ranged from 1-7, where 1 indicated very much improved and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Data is reported for the percentage of participants who were much improved and very much improved.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2814730|NCT00420641|Secondary|Percentage of Responders and Remitters of HAMD-17 Over Week 10|HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Responders were defined as participants who had a >=50% reduction from randomization in HAMD-17 total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a HAMD-17 total score <=7.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2814731|NCT00420641|Secondary|Percentage of Responders and Remitters of IDS-CR Over Week 10|IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score of IDS-CR calculated as : either item 11 or 12 scored; either item 13 or 14 scored; if both items scored, the highest of the items was used. Total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Responders were defined as participants who had a >=50% reduction from randomization in IDS-CR total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a IDS-CR total score <=14.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2814732|NCT00420641|Secondary|Percentage of Responders and Remitters of MADRS Over Week 10|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Responders were defined as participants who had a >=50% reduction from randomization in MADRS total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a MADRS total score <=11.|Up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2814733|NCT00420641|Secondary|Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8|The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. Rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to randomization.|Week 0 (Randomization) up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814734|NCT00420641|Secondary|Mean Change From Randomization in IDS-CR Total Score Over Week 8|The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization.|Week 0 (Randomization) up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814765|NCT00420459|Primary|Clinical Global Impressions- Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
2814735|NCT00420641|Secondary|Mean Change From Randomization in the MADRS Total Score Over Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization.|Week 0 (Randomization) up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814736|NCT00420641|Secondary|Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10|The CSFQ-14SF is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning. It is consisting of 14 items that measure sexual activity and sexual functioning. It measures five dimensions of sexual behavior: pleasure (1 item); desire/frequency (items 2 and 3); desire/interest (items 4, 5 and 6); arousal (items 7, 8 and 9); and orgasm (items 11, 12 and 13). Items 10 and 14 are included in the total score but not in any dimension score. Items were rated on an 5 point scale from 1 to 5. Total score ranged from 14 to 70, where higher scores indicate higher sexual functioning and lower score indicate lower sexual functioning. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the total score was the difference between CSFQ-14SF score at the individual time points being analyzed (Week 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814737|NCT00420641|Secondary|Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10|MEI 18 item-SF questionnaire was used to measure reductions in mental energy, physical energy, and social motivation. All items use either a 7-level (0-6) or 5-level (0-4) response scale; for questions 1, 2, and 13-18, response '0' indicates lower motivation, energy and interest and responses with higher scores indicate increased motivation, energy and interest. For questions 3-12, response '0' indicates higher motivation, energy and interest and responses with higher scores indicate lower motivation, energy and interest. Items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored. Total score ranges from 0-108, where 0 indicates lower motivation, energy and interest and higher score indicates higher motivation, energy and interest. Randomization value was defined as assessment value done on Week 0. Change from Randomization in total score was difference between MEI score at individual time points being analyzed (Week 1, 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814738|NCT00420641|Secondary|Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10|The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between CGI-S score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population with OC analysis. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814739|NCT00420641|Secondary|Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10|The IDS-CR and IDS-SR is a standardized 30-item scale rated by the clinician and the participant respectively to assess the severity of a participant's depressive symptoms. The 5 items of the IDS subscale include: item 19 (general interest/involvement), item 20 (energy/fatigability), item 21 (pleasure/enjoyment), item 22 (sexual interest), item 30 (Leaden paralysis/physical energy) which assessed participant's pleasure, interest and energy. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score ranges from 0 to 15, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS 5 Item subscale total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814740|NCT00420641|Secondary|Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10|HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a 3-point scale of 0-2 or a 5-point scale of 0-4. The item 1 (Depressed Mood) of HAMD-17 was rated the 5-point scale of 0-4, where 0 indicates absence of symptom and higher score indicates more severe symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between HAMD-17 Item 1 score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population with OC analysis. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814762|NCT00420459|Secondary|The Vineland Adaptive Behavior Scales|Vineland Adaptive Behavior Scales are a valid and reliable test to measure a person's adaptive level of functioning. Vineland-II forms aid in diagnosing and classifying intellectual and developmental disabilities and other disorders, such as autism spectrum disorders and developmental delays. The content and scales are organized within a 4 domain structure: Communication, Daily Living, Socialization and Motor Skills. The adaptive behavior composite standard score is computed from the sum of standard scores from the domains and converted into the adaptive behavior composite standard score. Higher scores indicate a higher adaptive level of functioning.|Screen Visit|Data for this outcome measure are unavailable because the data file was lost during a server migration.||||||
2814741|NCT00420641|Secondary|Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score|HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items of HAMD-17 are rated on a scale 3-point scale of 0-2 or a 5-point scale of 0-4 where 0 is absence of symptom and higher score indicate more severe symptom. Items rated on the 3-point scale include: insomnia early, middle, late; somatic symptoms gastrointestinal and general; genital symptoms; loss of weight; insight. Items rated on 5-point scale include: depressed mood; feelings of guilt; suicide; work and activities; retardation; agitation; anxiety psychic and somatic; hypochondriasis. Total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between HAMD-17 total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814742|NCT00420641|Secondary|Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10|The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The item 5 (Feeling Sad) of IDS-CR was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in score was the difference between IDS-CR Item 5 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814743|NCT00420641|Secondary|Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10|The MADRS scale measures the depression level of a participant. The items of the scale include: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. The item 2 (Reported Sadness) of MADRS was scored using a scale 7-point scale of 0-6, where 0 indicates absence of symptom and higher score indicates increased severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS Item 2 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814744|NCT00420641|Secondary|Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10|QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by participant. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of the items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-SR16 total score at the individual time points being analyzed (Week 1, 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814745|NCT00420641|Secondary|Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10|QIDS-CR16 is a 16-item rating scale of depressive symptoms rated by the clinician. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-CR16 total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814746|NCT00420641|Secondary|Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10|The IDS-SR is a standardized 30-item, participant rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-SR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-SR total score at the individual time points being analyzed (Week, 1, 4 and 10) to Randomization.|Week 0 (Randomization) up to Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814763|NCT00420459|Secondary|Social Responsiveness Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
2822843|NCT00362375|Other Pre-specified|Sexual Abstinence|The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up|||Percent|||Number
2814747|NCT00420641|Primary|Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score|The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814748|NCT00420641|Primary|Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score|The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. The rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814749|NCT00420641|Primary|Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time point being analyzed (Week 10) to Randomization.|Week 0 (Randomization) and Week 10|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2814750|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 3|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 3 (day 15)|Efficacy sample - Study eye|||Units on a scale 0-4||Standard Deviation|Mean
2814751|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 2|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 2 (day 8)|Efficacy population - Study eye|||Units on a scale 0-4||Standard Deviation|Mean
2814752|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 1|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 1 (day 1)|Efficacy sample, non-missing data|||Units on a scale 0-4||Standard Deviation|Mean
2814753|NCT00420628|Primary|Treatment Emergent Adverse Events|Study eye - Safety Population, At all visits 1,2,3|day 1, day 8, day 15|Safety population, Study eye|||participants|||Number
2814754|NCT00420628|Secondary|Investigators Global Assessment of the Clinical Condition|The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.|Visit 3, day 8|Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)|||Participants|||Number
2814755|NCT00420511|Secondary|Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy||1 year|||||||
2814756|NCT00420511|Secondary|Time to Loss of Glycemic Control||1 year|||||||
2814757|NCT00420511|Secondary|Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year||1 year|||||||
2814758|NCT00420511|Secondary|Fasting Blood Glucose at 48 Weeks||48 weeks||||mmol/l||Inter-Quartile Range|Median
2814759|NCT00420511|Secondary|Insulinogenic Index Divided by HOMA-IR at 48 Weeks|Insulinogenic index was calculated as the incremental change in insulin from 0 to 30 minutes divided by the incremental change in glucose over the same period of time. Insulinogenic index divided by HOMA-IR provides an additional measure of beta-cell function. A higher value indicates better beta-cell function|48 weeks||||index of beta-cell function||Inter-Quartile Range|Median
2814760|NCT00420511|Primary|Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR|Area-under-the-C-peptide-curve (AUCCpep) and area-under-the-glucose-curve (AUCgluc) from 0 to 240 minutes during meal tests were calculated using the trapezoidal rule. Insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Beta-cell function was assessed using the ratio of total AUCCpep to AUCgluc divided by HOMA-IR (AUCCpep/gluc/HOMA-IR), a measure of insulin secretion in the context of ambient insulin sensitivity, analogous to the disposition index and adaptation index. Higher AUCCpep/gluc/HOMA-IR is indicative of better beta-cell function.|48 weeks||||index of beta-cell function||Inter-Quartile Range|Median
2814761|NCT00420459|Secondary|The Vineland Maladaptive Behavior Subscales|The Vineland Adaptive Behavior Scales include an optional Maladaptive Behavior Index with 27 items. The Maladaptive Behavior Index is a composite of Internalizing, Externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The Maladaptive Behavior subscale yields raw scores (0-27).|Week 12|Data for this outcome measure are unavailable because the data file was lost during a server migration.||||||
2814766|NCT00420459|Primary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).|Obtained at Baseline and Week 12||||units on a scale||Standard Deviation|Mean
2814767|NCT00420420|Other Pre-specified|Baseline: Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Deviation|Mean
2814768|NCT00420420|Other Pre-specified|Baseline: ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Deviation|Mean
2814769|NCT00420420|Other Pre-specified|Baseline: Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Deviation|Mean
2814770|NCT00420420|Primary|Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Error|Mean
2814771|NCT00420420|Secondary|Week 4 Change From Baseline in Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Error|Mean
2814772|NCT00420420|Primary|Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.|||units on a scale||Standard Error|Mean
2814773|NCT00420407|Secondary|Level of Vasopressin After Trauma.|Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm|12 hours||||pg/ml||Standard Deviation|Mean
2814774|NCT00420407|Primary|The Primary Endpoint of This Study Will be Day 30 Mortality.|Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.|30 days||||Participants|||Number
2814775|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 130 mmHg|||mmHg||Standard Deviation|Mean
2814776|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 124 mmHg|||mmHg||Standard Deviation|Mean
2814777|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 120 mmHg|||mmHg||Standard Deviation|Mean
2814778|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 116 mmHg|||mmHg||Standard Deviation|Mean
2814779|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 112 mmHg|||mmHg||Standard Deviation|Mean
2814780|NCT00420342|Secondary|Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8|Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.|8 weeks plus 3 days|FAS subjects from the one site which performed the sodium sensitivity analysis|||participants|||Number
2814781|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements|Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values|||mmHg||Standard Error|Median
2814782|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements|Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values|||mmHg||Standard Error|Mean
2814783|NCT00420342|Secondary|Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough|Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline|||mmHg||Standard Error|Mean
2814784|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements|The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline|||mmHg||Standard Error|Mean
2814785|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.|||mmHg||Standard Error|Mean
2814786|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis used Full Analysis Set (FAS), which follows ITT principles; no imputation methods used; patients with missing data had no Blood Pressure (BP) values after baseline|||mmHg||Standard Error|Mean
2814787|NCT00420316|Secondary|Number of Subjects Reporting Intussusception (IS)|Intussusception is defined as the telescoping of the intestine.|During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)|The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.|||Subjects|||Number
2814788|NCT00420316|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.|||Subjects|||Number
2814789|NCT00420316|Secondary|Number of Subjects With Severe Gastroenteritis (GE)|Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814790|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814803|NCT00420290|Primary|High Sensitivity C-reactive Protein (hsCRP)|hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||mg/dl||Standard Deviation|Mean
2814791|NCT00420316|Secondary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814792|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814793|NCT00420316|Secondary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814794|NCT00420316|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)|Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814795|NCT00420316|Primary|Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)|Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.|During the study period for the long-term follow-up (i.e. 6 months)|The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.|||Subjects|||Number
2814796|NCT00420303|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12|The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Baseline and 12 weeks|All randomized patients who received at least 1 dose of test article.|||units on scale||Standard Deviation|Mean
2814797|NCT00420303|Secondary|Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity|A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.|12 weeks|All randomized patients who received at least 1 dose of test article.|||patients|||Number
2814798|NCT00420303|Primary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12|PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).|12 weeks|All randomized patients who received at least 1 dose of test article. Last observation carried forward (LOCF)|||mm||Standard Deviation|Mean
2814799|NCT00420290|Secondary|Lean Body Mass (LBM)|LBM is a measurement of body composition in terms of lean body mass as determined using Dual Energy X-ray Absorptiometry (DEXA) performed 1 to 2 hours after dialysis.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||kg||Standard Deviation|Mean
2814800|NCT00420290|Secondary|Serum Albumin|Albumin is a sensitive laboratory assay for serum levels of albumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||g/dl||Standard Deviation|Mean
2814801|NCT00420290|Secondary|Serum Prealbumin|Prealbumin is a sensitive laboratory assay for serum levels of prealbumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||mg/dl||Standard Deviation|Mean
2814802|NCT00420290|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interlukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.|||pg/ml||Standard Deviation|Mean
2822933|NCT00361439|Primary|Histological Findings|Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported|2 weeks||||eosinophils per HPF||Full Range|Median
2814804|NCT00420238|Secondary|Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.|||percent of participants|||Number
2814805|NCT00420238|Secondary|Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.|||percent of participants|||Number
2814806|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 14, Week 18, Week 24|Open-label population. In the case of missing data, no replacement or imputation method was performed.|||percent of participants|||Number
2814807|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||percent of participants|||Number
2814808|NCT00420238|Secondary|Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24|Percent of participants with normal (<6 milligrams per liter) and abnormal (>= 6 milligrams per liter) C-Reactive Protein.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of participants|||Number
2814809|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24|Change from baseline in C-reactive Protein (CRP).|Week 14, Week 18, Week 24|Open-label population; LOCF.|||milligrams per liter||95% Confidence Interval|Mean
2814810|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12|CRP is a marker of inflammation. A higher level is consistent with inflammation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. LOCF.|||milligrams per liter||95% Confidence Interval|Least Squares Mean
2814811|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the C-reactive Protein curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||milligrams per liter||95% Confidence Interval|Least Squares Mean
2814812|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||millimeters per hour||95% Confidence Interval|Mean
2814813|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||millimeters per hour||95% Confidence Interval|Least Squares Mean
2814814|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Erythrocyte Sedimentation Rate curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters per hour||95% Confidence Interval|Least Squares Mean
2814815|NCT00420238|Secondary|Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) due to AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814827|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two attempts on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814816|NCT00420238|Secondary|Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) because of AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = subgroup of subjects who reported performing daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit (Week 2 through Week 12).|||units on scale||95% Confidence Interval|Least Squares Mean
2814817|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters (cm).|Week 14, Week 18, Week 24|Open-label population; LOCF.|||centimeters||95% Confidence Interval|Mean
2814818|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||centimeters||95% Confidence Interval|Least Squares Mean
2814819|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Chest Expansion Test curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||centimeters||95% Confidence Interval|Least Squares Mean
2814820|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814821|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814822|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814823|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814824|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814825|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attemting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814826|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two tries on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||centimeters||95% Confidence Interval|Mean
2814851|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
2814828|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24|Cervical rotation: measurement in degree to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.|||units on scale||95% Confidence Interval|Mean
2814829|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12|Cervical rotation: measurement of degrees to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. In the case of missing data, no replacement or imputation method was performed.|||units on scale||95% Confidence Interval|Mean
2814830|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814831|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
2814832|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12|BASMI was composed of 5 measures; each measure scored 0-2 (0=normal mobility, 2=severe reduction); final score range: 0 to 10. Normalized net incremental area under the curve (AUC) = area between baseline and the BASMI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||millimeters||95% Confidence Interval|Least Squares Mean
2814833|NCT00420238|Secondary|Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)||Baseline, Week 12|mITT; N=number of subjects with evaluable data. In the case of missing data, no replacement or imputation method was performed.|||percent||95% Confidence Interval|Least Squares Mean
2814834|NCT00420238|Secondary|Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)||Baseline, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.|||liters||95% Confidence Interval|Least Squares Mean
2814835|NCT00420238|Secondary|Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12|Subject evaluation of the effect of their disease on well-being over the last week using a using a 100 millimeter Visual Anaog Scale; range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Mean
2814836|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very important.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814837|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||units on scale||95% Confidence Interval|Least Squares Mean
2814838|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12|BAS-G was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=none to 100=very important. Normalized net incremental area under the curve (AUC) = area between baseline and the BAS-G curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
2814839|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24|BASDAI subject rated components over last 48 hours using a 100 millimeter Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3)Overall level of pain/swelling in joints other than neck,back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening.|Week 14, Week 18, Week 24|Open-label population; in case of missing data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.|||units on scale||95% Confidence Interval|Mean
2814864|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (versus baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
2814840|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12|BASDAI subject rated components over last 48 hours using 100 mm Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness subscale.|Week 2, Week 4, Week 8, Week 12|mITT; in case of mising data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.|||units on scale||95% Confidence Interval|Mean
2814841|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis (AS) in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814842|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on a scale||95% Confidence Interval|Least Squares Mean
2814843|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24|Subject rating of last 48 hours, 100 mm Visual Analog Scale; range 0=easy to 100=impossible: 1) Putting on socks/tights without (w/o) help; 2) Bending forward from waist to pickup pen from floor w/o aid; 3) Reaching to high shelf w/o aid; 4) Getting out of armless dining room chair w/o using hands/other help; 5) Getting up off floor w/o help from lying on back; 6) Standing unsupported 10 minutes w/o discomfort; 7) Climbing 12-15 steps w/o handrail or walking aid; 8) Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C=component (number), Act=Activities.|||units on a scale||95% Confidence Interval|Mean
2814844|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12|Subject rating of last 48 hours, 100 millimeter Visual Analog Scale; range 0=easy to 100=impossible: 1)Putting on socks/tights without (w/o) help; 2)Bending forward from waist to pickup pen from floor w/o aid; 3)Reaching to high shelf w/o aid; 4)Getting out of armless dining room chair w/o using hands/other help; 5)Getting up off floor w/o help from lying on back; 6)Standing unsupported 10 minutes w/o discomfort; 7)Climbing 12-15 steps w/o handrail or walking aid; 8)Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C = component (number), Act = Activities.|||units on a scale||95% Confidence Interval|Mean
2814845|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12|BASFI is a validated self assessment tool that determines the degree of functional limitation in ankylosing spondylitis (AS) patients using a 100 millimeter (mm) Visual Analog Scale (VAS) measuring level of ability with activities in the last 48 hours; range: 0=easy to 100=impossible. Higher score = greater limitation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||units on scale||95% Confidence Interval|Least Squares Mean
2814846|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12|BASFI was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = easy to 100 = impossible. Normalized net incremental area under the curve (AUC) = area between baseline and the BASFI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
2814847|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 14, 18, 24|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814848|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
2814849|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12|Total back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Total Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
2814850|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814852|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12|Nocturnal back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Nocturnal Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
2814853|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814854|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||units on scale||95% Confidence Interval|Least Squares Mean
2814855|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC) = area between baseline and the Physician Global Assessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N= number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
2814856|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||units on scale||95% Confidence Interval|Mean
2814857|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||units on scale||95% Confidence Interval|Least Squares Mean
2814858|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC)=area between baseline and the Patient Global Asessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.|||millimeters||95% Confidence Interval|Least Squares Mean
2814859|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of participants|||Number
2814860|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
2814861|NCT00420238|Secondary|Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of participants|||Number
2814862|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
2814863|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.|||percent of particpants|||Number
2814900|NCT00420147|Primary|Knee Adduction Moment After 12 Months||12 months||||Nm/(kg-m)||Standard Deviation|Mean
2814865|NCT00420238|Secondary|Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 units (millimeters) on a 0-100 scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population: all subjects who received at least 1 dose of open test article (Etanercept). LOCF.|||percent of participants|||Number
2814866|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function,and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 millimeters (mm) on a 0-100 mm scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
2814867|NCT00420238|Secondary|Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.|||percent of participants|||Number
2814868|NCT00420238|Primary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12|BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|Modified Intent-To-Treat (mITT) population: includes all randomized subjects who received at least 1 dose of blinded study drug. Last observation carried forward (LOCF).|||millimeters||95% Confidence Interval|Least Squares Mean
2814869|NCT00420212|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution.|2 years|The analysis population consisted of the ITT population (all subjects who were randomized and received at least 1 dose of study medication) who had a baseline EDSS assessment. Analysis were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.|||Proportion of participants|||Number
2814870|NCT00420212|Secondary|Annualized Relapse Rate|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.|2 years|The ITT population was defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Relapses per year||95% Confidence Interval|Mean
2814871|NCT00420212|Secondary|Number of Subjects With Gadolinium (Gd)-Enhancing Lesions|"Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure Number of Gadolinium-enhancing T1-weighted lesions"|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption|||Number of subjects|||Number
2814872|NCT00420212|Secondary|Number of Gadolinium-enhancing T1-weighted Lesions|The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption|||Number of lesions||Standard Deviation|Mean
2814873|NCT00420212|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume|2 years|Of the 540 subjects included in the MRI cohort, 469 subjects (165 placebo, 152 BG00012 BID, 152 BG00012 TID) had post-baseline T2 data and were included in the analysis. Missing data before the use of alternative MS medications and visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption.|||Number of lesions||95% Confidence Interval|Mean
2814901|NCT00420147|Primary|Knee Adduction Moment at Baseline||Baseline||||Nm/(kg-m)||Standard Deviation|Mean
2814874|NCT00420212|Primary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.|||Proportion of subjects,confirmed relapse|||Number
2814875|NCT00420199|Secondary|Double-blind Period: Number of Participants With Positive Antibodies to Abatacept by Electrochemiluminescence (ECL) Assay|On-Rx=on treatment; post-Rx=post treatment. ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1.|Day 1 to Day 113|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814876|NCT00420199|Secondary|Double-blind Period:Number of Participants With Significantly Abnormal Changes in Vital Signs|Vital signs, which included blood pressure, heart rate, respiration, and temperature, were monitored predose and 1 hour after start of infusion. Changes in vital signs were determined to be significantly abnormal at the discretion of the investigator but were generally those that either exceeded, or failed to reach, normal parameters. Normal vital sign parameter ranges varied by site.|Days 1, 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814877|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis score=Follow-up synovitis score-baseline synovitis score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and who had wrist synovitis assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
2814878|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Other Chemistries and Urinalysis Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL-baseline. Marked abnormality c: serum glucose:<65 mg/dL/>220 mg/dL; fasting serum glucose: <0.8* LLN/>1.5* ULN, or if BL<LLN, use 0.8*BL or >ULN, or if BL>ULN, use >2.0*BL or <LLN; total protein: <0.9*LLN/>1.1* ULN; albumin: <0.9*LLN,or if BL<LLN, use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN, use >2*BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, red blood cells, white blood cells):Use ≥2 when BL value missing or value ≥4,or when predose=0 or 0.5. Use ≥3 when predose=1. Use ≥4 when predose=2 or 3|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814879|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Electrolytes Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Marked abnormality: Sodium: <0.95*LLN/>1.05*ULN,or if BL<LLN, use 0.95*BL or >ULN,or if BL>ULN, use>1.05*BL or <LLN. Potassium: <0.9*LLN/>1.1* ULN,or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Chloride: <0.9*LLN/>1.1*ULN, or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Calcium: <0.8*LLN/>1.2*ULN, or if BL<LLN, use 0.75*BL or >ULN, or if BL>ULN, use>1.25*BL or <LLN. Phosphorous: <0.75*LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33*BL or <LLN.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814880|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Liver and Kidney Function Meeting Criteria for Marked Abnormality|ULN=upper limit of normal; BL=baseline. Marked abnormality criteria: Alkaline phosphatase: >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase: >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase: >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase: >2*ULN, or if BL>ULN, use >3*BL; Bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2*BL; creatinine: >1.5*BL.|From Day 1 to Day 113, and including up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814881|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality|BL=baseline; LLN=lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL. Hematocrit: <0.75*BL. Erythrocytes: <0.75*BL. Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3. Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN. Neutrophils+bands: <1.0*10^3 c/uL. Eosinophils: >0.750*10^3 c/uL. Basophils: > 400 mm^3. Monocytes: >2000 mm^3. Lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814902|NCT00420095|Secondary|Hypoglycemia Rate Per Participant Per 30 Days|Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.|over 12 weeks of each treatment period|Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||events/30 days||95% Confidence Interval|Mean
2814882|NCT00420199|Secondary|Double-blind Period: Number of Participants With Peri-infusional AEs of Special Interest|Peri-infusional AEs are AEs occurring during the first 24 hours after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events, Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814883|NCT00420199|Secondary|Double-blind Period: Number of Participants With Acute Infusional AEs of Special Interest|Acute infusional AEs are AEs with onset during the first hour after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events ,Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814884|NCT00420199|Secondary|Double-blind Period: Number of Participants With Infections/Infestations of Special Interest|Infections/Infestations of Special Interest are AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814885|NCT00420199|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including serious, opportunistic, and all other infections; autoimmune disorders; neoplasms; acute infusional AEs (prespecified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (prespecified AEs occurring within 24 hours of start of infusion).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814886|NCT00420199|Secondary|Double-blind Period: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.|||participants|||Number
2814887|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Marker of Synovial Tissue Metabolism (Creatinine-corrected Urinary Glucosyl-Galactosyl-Pyridinoline [UGGPC])|Glucosyl-galactosyl-pyridinoline (Glc-Gal-PYD) is a specific biochemical marker reflecting the degradation of the synovial tissue membrane. It is a glycosylated derivative of the collagen crosslink pyridinoline, and it is present in significant amounts only in the synovial membrane; it is absent from bone and present in minutes amounts in cartilage and other soft tissues. Increased urinary levels of Glc-Gal-PYD have been found in early and long-standing rheumatoid arthritis, high levels being associated with rapid destruction.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
2814888|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in a Systemic Marker of Cartilage Degradation (Creatinine-corrected Urinary Carboxyterminal Crosslinking Telopeptide of Type II Collagen [UCTX2C])|Urinary CTX-II is a biochemical marker of type II collagen breakdown. In participants with early rheumatoid arthritis, increased levels of CTX-II can be predictive of rapid radiographic progression over periods of 1 to 5 years. These markers of cartilage destruction can predict progression of joint damage, independent of clinical and biologic indices of disease activity and baseline joint damage.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
2814889|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Destruction (Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen [CTX-I] and Serum Pyridinoline Cross-linked Telopeptide Domain of Type I Collagen [ICTP])|CTX-I and ICTP are biochemical markers of bone resorption or bone degradation|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
2814890|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Formation: Osteocalcin and Serum Intact N-terminal Propeptide of Type I Procollagen (PINP)|PINP and osteocalcin are markers of bone formation. Osteocalcin is synthesized by osteoblasts and is associated with osteoblast synthetic activity. Osteoblasts secrete type 1 procollagen, and cleavage of large fragments from the carboxy and amino terminal ends result in formation of mature type 1 collagen and production of PINP fragments.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.|||percent change||Inter-Quartile Range|Median
2815192|NCT00418262|Primary|Pittsburg Side-Effects Scale: Motor Tics|"Motor Tics~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|Children with FAS participating in the extend safety efficacy study|||units on a scale||Standard Deviation|Mean
2814891|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in RAMRIS Scores|RAMRIS Score=sum of core components: Synovitis (S), Osteitis (O), and Erosion (E) Scores. S scored 0 (none) to 9 (maximum distension of synovial cavity); O scored 0 (none) to 69 (maximum articular bone involvement); E scored 0 (none) to 230 (maximum erosion of articular bone). RAMRIS=S+O+E Scores. RAMRIS minimum score=0 (normal), maximum=308 (severe structural damage). Adjusted change from baseline in RAMRIS=mean RAMRIS at Day 113-mean RAMRIS at baseline. Adjustment based on ANCOVA model: treatment=factor, baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
2814892|NCT00420199|Secondary|Double-blind Period: Baseline Mean RAMRIS Scores|RAMRIS score is the sum of its core components: Synovitis Score, Osteitis Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Osteitis scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Osteitis Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Osteitis Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Baseline|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline.|||units on a scale||Standard Deviation|Mean
2814893|NCT00420199|Secondary|Double-blind Period: Number of Participants With Newly Involved Joints in Bone Erosion, Edema/Osteitis, and Synovitis|Bone erosion and osteitis were assessed at a total of 23 anatomic locations according to erosion (for bone erosion) or involvement (for osteitis) of the original articular bone. Synovitis assessed as above-normal post-gadolinium enhancement in 3 wrist regions: distal radioulnar joint, radiocarpal joint, and intercarpal and carpometacarpal joints.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion, edema, and synovitis assessments available at baseline and Day 113.|||participants|||Number
2814894|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Osteitis OMERACT 6 Scores|Osteitis assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached. Each site scored in 1.0 increments, indicating involvement of original articular bone (0=none to 3=severe). Total score for hands/wrists is sum of scores for each location. Maximum score per hand/wrist is 23 (total anatomic locations)*3 (maximum score per joint)=69. Minimum score=0(normal). Increasing score=greater severity. Adjusted mean change from baseline in osteitis score=mean score at Day 113-mean score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
2814895|NCT00420199|Secondary|Double-blind Period: Baseline Mean Osteitis OMERACT 6 Scores|Osteitis assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline.|||units on a scale||Standard Deviation|Mean
2814896|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis=Follow-up synovitis score-baseline score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had wrist synovitis assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
2814897|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Erosion OMERACT 6 Scores|Bone erosion assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached hand. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. Total erosion score for hands/wrists is sum of the individual scores for each location. Thus the maximum score per hand/wrist is 230. Increasing score=greater severity. Adjusted change from baseline in erosion score=mean score at Day 113-mean erosion score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline and Day 113.|||units on a scale||Standard Deviation|Mean
2814898|NCT00420199|Secondary|Double-blind Period: Baseline Mean Erosion OMERACT 6 Scores|Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline.|||units on a scale||Standard Deviation|Mean
2814899|NCT00420199|Primary|Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS)|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|At baseline|All randomized participants who received at least 1 dose of study medication and had synovitis assessments available at baseline.|||units on a scale||Standard Deviation|Mean
2814903|NCT00420095|Secondary|Number of Participants With Laboratory Parameters Significantly Different From Baseline|Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||participants|||Number
2814904|NCT00420095|Secondary|Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%|Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.|12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||participants|||Number
2814905|NCT00420095|Secondary|Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment|Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.|||units of insulin||95% Confidence Interval|Mean
2814906|NCT00420095|Secondary|Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment|Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.|||millimoles/Liter||95% Confidence Interval|Mean
2814907|NCT00420095|Secondary|Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment|Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.|Baseline and at 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
2814908|NCT00420095|Primary|Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint|Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.|||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
2814909|NCT00420056|Secondary|Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21|Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|PD 0332991 concentration was analyzed using pharmacokinetic analysis set (participants in FAS who had also completed pharmacokinetic blood sampling for at least 1 day); SUVmax and biomarkers were analyzed using imaging analysis set and tumor analysis set respectively. n= participants evaluable for this measure for specified comparisons.|||correlation coefficient|||Number
2814910|NCT00420056|Secondary|Time to Tumor Progression (TTP)|Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.|||months||95% Confidence Interval|Median
2814911|NCT00420056|Secondary|Duration of Response (DR)|Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease. PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|For duration of response, the number of participants experiencing objective response was less than 50%, and therefore, it was not feasible to calculate duration of response using Kaplan-Meier method. Hence, no participant was analyzed for this outcome measure.||||||
2814912|NCT00420056|Secondary|Percentage of Participants With Objective Response|OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.|||percentage of participants||95% Confidence Interval|Number
2814913|NCT00420056|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.|||months||95% Confidence Interval|Median
2814914|NCT00420056|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
2814915|NCT00420056|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity|AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
2814916|NCT00420056|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory test abnormality: Hematology (Hemoglobin [<0.8*lower limit of normal {LLN}], Platelets [<0.5*LLN/ >1.75*upper limit of normal {ULN}], White blood cells [<0.6*LLN/ >1.5*ULN], Lymphocytes, Neutrophils [<0.8*LLN/ >1.2*ULN], Basophils, Eosinophils, Monocytes [>1.2*ULN]); Liver Function (Total bilirubin [>1.5*ULN], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase [>0.3*ULN], Total protein, Albumin [<0.8*LLN/ >1.2*ULN]); Renal Function (Blood urea nitrogen, Creatinine [>1.3*ULN], Uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/ >1.05*ULN], potassium, chloride, calcium, magnesium [<0.9*LLN/ >1.1*ULN], phosphate [<0.8*LLN/ >1.2*ULN]); Other (Glucose [<0.6*LLN/ >1.5*ULN]).|Baseline up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
2814917|NCT00420056|Primary|Cyclin D1 Composite Score at Cycle 1 Day 21|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2814918|NCT00420056|Primary|Cyclin D1 Composite Score at Baseline|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2814919|NCT00420056|Primary|Ki-67 Composite Score at Cycle 1 Day 21|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2815193|NCT00418184|Secondary|Lipid Profile (Cholesterol, HDL, Triglycerides)||on weeks 0,15|||||||
2815194|NCT00418184|Secondary|Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca||on weeks 0,15|||||||
2814920|NCT00420056|Primary|Ki-67 Composite Score at Baseline|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2814921|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of tumor cells||Standard Deviation|Mean
2814922|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of tumor cells||Standard Deviation|Mean
2814923|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)|OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by >50% in SPD, no new sites of disease; SD= response <PR and no PD, documented >=1 time after start of therapy, no new sites of disease; PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax <75% of baseline; PD= mean SUVmax >125% of baseline; SD= mean SUVmax >=75% of baseline but <=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR|PET response was analyzed using Imaging analysis set and OR was analyzed using response analysis set (all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed).|||participants|||Number
2814924|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)|PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (>=) 75% of baseline and mean SUVmax less than or equal to (<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS|Analysis for this outcome measure was not run as there were so few responders.||||||
2814925|NCT00420056|Primary|Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Change from baseline in SUVmax was assessed using [(18)F]-FLT-PET and [(18)F]-FDG-PET techniques.|Baseline, Cycle 1 Day 21|Imaging analysis set included participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment (Day 21) PET.|||standard uptake value (SUV)||Standard Deviation|Mean
2814926|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).|||correlation coefficient|||Number
2814936|NCT00420004|Secondary|Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score|The HAMD-21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 60 (severely depressed). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMD-21 value.|||units on a scale||Standard Error|Least Squares Mean
2815195|NCT00418184|Secondary|Complete Blood Counts||on weeks 0,15|||||||
2814927|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-fluorodeoxyglucose PET [FDG-PET] and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).|||correlation coefficient|||Number
2814928|NCT00420017|Secondary|Number of Participants With Adverse Effects|Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)|7 days|Per protocol|||patients|||Number
2814929|NCT00420017|Secondary|Length of Post-surgical Intensive Care Unit Stay||7 days||||hours||Inter-Quartile Range|Median
2814930|NCT00420017|Secondary|Length of Post-surgical Hospital Stay||Duration of hospitalization||||days||Inter-Quartile Range|Median
2814931|NCT00420017|Primary|Incidence of Atrial Fibrillation||7 days|Analysis was per protocol|||participants|||Number
2814932|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint|Trail Making A is a neurocognitive test associated with general brain function. While being timed, the participant is instructed to connect 25 randomly placed circled numbers on a page in numerical sequence without lifting their pencil. If a participant makes a mistake, the mistake is pointed out and the participant must start again from the last correct circle. The total time to complete the task (up to 300 seconds, with a lower value indicating better brain function) is recorded. Least squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline Trail Making A value. Last observation carried forward (LOCF) methodology was used.|||seconds||Standard Error|Least Squares Mean
2814933|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint|The Two Digit Cancellation Test (2DCT) is a clinical adaptation of the visual search tasks that have been used to investigate cognitive processes involved in attention and visual information processing. For this test, the participant is presented with a piece of paper containing rows of digits. At the top of the page are two target digits. The participant is instructed to examine each row of digits working from top to bottom and left to right crossing off each number that matches either of the two numbers at the top of the page. The number of targets hit, number of errors, and number of times the participant had to be reminded of the task are recorded for the 45-second test. The 2DCT composite cognitive score is calculated as the number of targets hit - number of errors - number of reminders. 2DCT score ranges 0-40 with higher score indicating better cognition. Least squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline 2DCT value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
2814934|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint|The SDST is an attention-demanding psychomotor component based on the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale. The participant is given a symbol/digit code in which each of the digits 1 through 9 is paired with a different symbol. Below the code, a series of symbols selected from those in the code are presented in an irregular order. The participant is instructed to write the number that is appropriate for each symbol in the space below each symbol and to complete as many correct digits as possible within a 90-second test period. For this test, the number of attempts and number of correct digits is collected. The percentage of correct digits is presented based on the number of correct digits divided by the number of attempts, multiplied by 100 (score ranged from 0 to 100% correct). Least squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline SDST value. Last observation carried forward (LOCF) methodology was used.|||percentage of correct digits||Standard Error|Least Squares Mean
2814935|NCT00420004|Secondary|Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint|The WLDRT is a test of visual learning and recall. Participants are shown a series of words (commonly used nouns) and asked to say each of the words aloud, then are asked to recall the words and the total number of correct words recalled is recorded (possible score ranged from 0 to 15 words). The process is repeated 3 times. The Word List Learning Test score is calculated as the average number of words recalled during the first 3 trials. After a 30-minute delay, participants are again asked to recall the words, and the total number of correct words remembered after the delay is recorded as the Delayed Recall Test score. The baseline value was the last non-missing value before the first randomized double-blind study drug administration. Least Squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to week 8|All randomized participants who received at least one dose of double-blind study drug and who have a baseline and at least one post-baseline WLDRT value. Last observation carried forward (LOCF) methodology was used.|||number of correct words||Standard Error|Least Squares Mean
2814937|NCT00420004|Secondary|Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability)|The number of participants with at least one serious adverse event, regardless of causality is reported cumulatively through Week 8. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Baseline through Week 8|All randomized participants.|||Participants|||Count of Participants
2814938|NCT00420004|Secondary|Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint|Predicted maximal LY2216684 plasma concentrations at steady state (Cmax,ss) are reported, using the dose at the last visit in the study for participants included in the primary efficacy analysis.|Up to 8 weeks|All participants randomized to LY2216684 included in the primary efficacy analysis with a pharmacokinetic (PK) sample at the participants' final study visit.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2814939|NCT00420004|Secondary|Change From Baseline to Week 8 in Fatigue Severity Scale|"Fatigue Severity Scale (FSS) is a 9-item measure of fatigue severity. Each item is scored by the participant on a scale of 1 (Disagree) to 7 (Agree), with a higher score indicating a stronger agreement with the item statement regarding the participant's fatigue symptoms. The FSS total score ranges from 1 to 7, and is obtained by averaging the responses to the 9 items. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit."|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline FSS value.|||units on a scale||Standard Error|Least Squares Mean
2814940|NCT00420004|Secondary|Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint|The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the participant's perception of his or her insomnia. The ISI score is calculated as the sum of the responses to the 7 items of the ISI scale. Each item is rated on a 0 to 4 scale and the total score ranges from 0 to 28 with a higher score suggesting more severe insomnia.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline ISI value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2814941|NCT00420004|Secondary|Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint|The Arizona Sexual Experiences Scale (ASEX) is used to assess sexual functioning in both males and females. The ASEX total score for the male and female version is calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline ASEX value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2814942|NCT00420004|Secondary|Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint|OAS-M is a clinician-administered semistructured interview designed to assess various manifestations of aggressive behavior. Final scores are rated on 3 scales: Aggression (Agg), Irritability (Irrt), Suicidality (Suic). Agg scale has 4 subscales: Verbal Assault (Aslt), Aslt Against Objects, Aslt Against Others, Aslt Against Self; each item is scored 0-5, multiplied by the frequency of the behavior, then summed together. Agg total score is the weighted sum of the subscale scores (weights: 1=Verbal Aslt, 2=Aslt Against Objects, 3=Aslt Against Others, 4=Aslt Against Self). The Irrt scale has 2 subscales: Global Irrt, Subjective Irrt. Suic scale has 3 subscales: Suicidal Tendencies, Intent of Attempt, Lethality of Attempt. The 2 Irrt and 3 Suic subscales are rated on 6 or 7 point scales from 0=none/not at all to 6/7=very extreme. The total score ranges from 0-10 for the Irrt scale and 0-16 on the Suic scale. Least Squares means were adjusted for treatment, investigator, and baseline s|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline OAS-M value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
2814943|NCT00420004|Secondary|Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint|Beck Scale for Suicide Ideation (BSI) is a 21-item participant-completed questionnaire designed to assess severity of suicidal ideation in adults and adolescents. The BSI total score is calculated as the sum of the responses (rated from 0 to 2 in terms of severity) to the first 19 items of the BSI scale. The BSI total score ranges from 0 to 38, with a higher score indicating a higher degree of suicide ideation.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline BSI value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2814944|NCT00420004|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint|The Quick Inventory of Depressive Symptomatology is a 16-item participant-rated measure of depressive symptomatology. There were 4 possible answers per question that are specific to the question; each question (Q) was scored 0 (no problems) to 3 (increased symptoms). The total score was the sum of the highest number from Q1-4, number from Q5, highest number from Q6-9, total for Q10-14, and the highest number from Q15-16. The total score ranges from 0 to 27 with higher scores indicative of greater severity of depression. Least Squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline Quick Inventory of Depressive Symptomatology value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
2814945|NCT00420004|Secondary|Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint|The SF-36 Health Status Survey is a generic, health-related scale assessing a participant's quality of life on 8 domains: general health (GH), physical functioning (PF), role-physical, role-emotional, social functioning, bodily pain, vitality, and mental health. Each domain is scored by summing the individual items (GH [range: 5-25]; PF [range: 10-30]; role-physical [range: 4-8]; role-emotional [range: 3-6]; social functioning [range: 2-10]; bodily pain [range: 2-11]; vitality [range: 4-24]; mental health [range: 5-30]) and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores (mental component and physical component scores) were constructed based on the 8 SF-36 domains. Mental component summary and physical component summary scores range from 0 to 100 (higher scores indicate better health status).|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline SF-36 Health Status Survey value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
2815196|NCT00418184|Secondary|Barkley Side Effects Rating Scale (SERS)||on weeks 0,15|||||||
2814946|NCT00420004|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint|The HAMA is a 14-item assessment used to assess the severity of anxiety. The investigator talked to the participant about the symptoms he or she experienced during the previous week. Each item was scored using a 5-point scale (0=not present to 4=very severe). The total score of HAMA ranged from 0 (normal) to 56 (severe). Least Squares (LS) means were adjusted for treatment, investigator, and baseline score.|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMA value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
2814947|NCT00420004|Secondary|Clinical Global Impression of Improvement Score at Week 8|The Clinical Global Impression of Improvement (CGI-I) scale measures the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, and treatment-by-visit.|Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline CGI-I value.|||units on a scale||Standard Error|Least Squares Mean
2814948|NCT00420004|Secondary|Response and Remission Rates|A participant meets response criteria if there is at least a 50% reduction in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the last observation carried forward (LOCF) endpoint visit. A participant meets remission criteria if the HAMD-17 total score is less than or equal to 7 at the LOCF endpoint visit. The percent of participants meeting criteria is summarized. HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed).|Baseline, up to Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMD-17 total score value. Last observation carried forward (LOCF) methodology was used.|||percentage of participants|||Number
2814949|NCT00420004|Secondary|Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17)|"The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The Maier-Phillip subscale of the HAMD-17 represents the 6 core symptoms of depression (items: 1=depressed mood, 2=feelings of guilt, 7=work and activities, 8=retardation, 9=agitation, 10=anxiety/psychic). The subscale scores range from 0 (normal) to 24 (severe). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit."|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline Maier-Philipp subscale value.|||units on a scale||Standard Error|Least Squares Mean
2814950|NCT00420004|Primary|Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score|The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Baseline, Week 8|All randomized participants who received at least one dose of double-blind study drug and who had a baseline and at least one post-baseline HAMD-17 value.|||units on a scale||Standard Error|Least Squares Mean
2814951|NCT00419952|Secondary|Asthma Treatment Satisfaction Measure (ATSM)|Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||units on a scale||95% Confidence Interval|Least Squares Mean
2814952|NCT00419952|Secondary|Forced Expiratory Volume in One Second (FEV1)|Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Litres||95% Confidence Interval|Least Squares Mean
2814953|NCT00419952|Secondary|Peak Expiratory Flow (PEF) in Morning|Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Liters/minute||95% Confidence Interval|Least Squares Mean
2814954|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|"Number of participants with positive response to Item 5 in questionnaire During the past week, you were satisfied with how quickly you felt your study medication begin to work. The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of strongly agree or somewhat agree"|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Participants|||Number
2815037|NCT00419315|Secondary|Percent Days of Heavy Alcohol Use|This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).|6 months||||percentage of heavy drinking days||Standard Deviation|Mean
2815197|NCT00418184|Secondary|Essential Fatty Acid (EFA)-Deficiency Symptoms||on weeks 0,15|||||||
2814955|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|"Number of participants with positive response to Item 2 in questionnaire During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of strongly agree or somewhat agree"|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Participants|||Number
2814956|NCT00419952|Secondary|Diary Assessments - Asthma-control Day|"Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered no to having symptoms and 0 to the use of rescue medication that day"|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||percentage of Asthma-control day||95% Confidence Interval|Least Squares Mean
2814957|NCT00419952|Secondary|Diary Assessments - Symptom-free Day|"Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered no to having symptoms that day"|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||percentage of Symptom-free day||95% Confidence Interval|Least Squares Mean
2814958|NCT00419952|Secondary|Diary Assessments - Rescue-free Day|"Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered no to having used rescue medication that day"|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Percentage of Rescue Free Day||95% Confidence Interval|Least Squares Mean
2814959|NCT00419952|Secondary|Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment|Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.|||Participants|||Number
2814960|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients|||Participants|||Number
2814961|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.|||Participants|||Number
2814962|NCT00419952|Secondary|QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)|QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||msec||95% Confidence Interval|Least Squares Mean
2814963|NCT00419952|Secondary|Asthma Exacerbations|Number of participants with at least 1 exacerbation|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Participants|||Number
2814964|NCT00419952|Primary|Total Number of Asthma Exacerbations|An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.|||Exacerbations|||Number
2814965|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Per Protocol (PP) population.|||number of participants|||Number
2814966|NCT00419926|Secondary|Renal Function Assessed by Serum Creatinine at Each Visits||at 21 days, 84 days and 180 days|||||||
2814967|NCT00419926|Secondary|Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit|The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m^2.|at 21 days, 84 days and 180 days|Intention to treat (ITT) population.|||(mL/min/1.73m^2)||Standard Deviation|Mean
2814968|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Per Protocol (PP) population.|||number of participants|||Number
2815038|NCT00419315|Primary|Treatment Engagement|This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.|6 months||||percentage of participants engaged|||Number
2814969|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Intention to treat (ITT) population.|||number of participants|||Number
2814970|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Intention to treat (ITT) population.|||number of participants|||Number
2814971|NCT00419770|Primary|Total Adverse Events||30 Days After End of Therapy||||Events|||Number
2814972|NCT00419770|Secondary|Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation||Up to 90 days|||||||
2814973|NCT00419770|Secondary|Deferasirox Pharmacokinetic and Pharmacodynamic Parameters||7 days|||||||
2814974|NCT00419770|Primary|Global Response Rate (Composite of Clinical and Radiographic Response) at End of Study Drug Administration, as Determined by a Blinded Adjudication Committee||14 days|||||||
2814975|NCT00419770|Primary|Safety and Tolerability of Adjunctive Deferasirox Therapy in Patients Being Treated With LAmB for Mucormycosis||14 days|||||||
2814976|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications|Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
2814977|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication|Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
2814978|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index|Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
2814979|NCT00419757|Secondary|Physician Global Assessment|"The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as Yes and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Perscentage of Participants|||Number
2814980|NCT00419757|Secondary|Subject Global Assessment|"The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as Yes and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percent of Participants|||Number
2814981|NCT00419757|Secondary|Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of days||Standard Error|Least Squares Mean
2814982|NCT00419757|Secondary|Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of days||Standard Error|Least Squares Mean
2814983|NCT00419757|Secondary|Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment|Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||puffs/day||Standard Error|Least Squares Mean
2815069|NCT00418977|Secondary|BMI|body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year||||kg/m^2||Standard Deviation|Mean
2814984|NCT00419757|Secondary|Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks|Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of nights||Standard Error|Least Squares Mean
2814985|NCT00419757|Secondary|Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.~Daily scale:~0 = No symptoms~1 = Mild symptoms~2 = Moderate symptoms~3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
2814986|NCT00419757|Secondary|Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.~Daily scale:~0 = No symptoms~1 = Mild symptoms~2 = Moderate symptoms~3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Units on a scale||Standard Error|Least Squares Mean
2814987|NCT00419757|Secondary|Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Liters/minutes||Standard Error|Least Squares Mean
2814988|NCT00419757|Secondary|Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline, 2, 6 and 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Liters||Standard Error|Least Squares Mean
2814989|NCT00419757|Secondary|"Percentage of Participants With Withdrawals Due to Pre-defined Asthma Events"|"Percentage of participants with Withdrawals Due to Pre-defined Asthma Events as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated."|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of Participants|||Number
2814990|NCT00419757|Secondary|Percentage of Participants With Pre-defined Asthma Events|Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Percentage of Participants|||Number
2814991|NCT00419757|Primary|Morning Peak Expiratory Flow (AM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|||Liters/minutes||Standard Error|Least Squares Mean
2814992|NCT00419744|Primary|Rate of Exacerbations Per Subject-year|Rate of exacerbations per subject-year|12 months||||Rate|||Number
2814993|NCT00419744|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.|12 months||||Scores on a scale||Standard Deviation|Mean
2814994|NCT00419744|Secondary|Use of Rescue Medication|Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.|12 months||||Number of inhalations||Standard Deviation|Mean
2814995|NCT00419744|Secondary|Dyspnea Symptom Scores|Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.|12 months||||Scores on a scale||Standard Deviation|Mean
2814996|NCT00419744|Secondary|Evening PEF|Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.|12 months||||L/min||Standard Deviation|Mean
2814997|NCT00419744|Secondary|Morning Peak Expiratory Flow (PEF)|Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.|12 months||||L/min||Standard Deviation|Mean
2814998|NCT00419744|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.|12 months||||Liters (L)||Standard Deviation|Mean
2814999|NCT00419744|Primary|Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year|Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.|12 months||||Exacerbations|||Number
2815070|NCT00418977|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year||||pounds||Standard Deviation|Mean
2815198|NCT00418184|Secondary|Vital Signs||on weeks 0,15|||||||
2815000|NCT00419666|Secondary|Number of Participants With Adverse Events|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.|From start of the study to Day 56|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||Participants|||Count of Participants
2815001|NCT00419666|Secondary|Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56|Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.|From baseline (Day 0) up to Day 56|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||Ratio||Standard Deviation|Mean
2815002|NCT00419666|Secondary|Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56|Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.|From baseline (Day 0) up to Day 56|Safety population consisted all participants in the ITT population who had applied the study medication at least once.|||Millimoles Per Litre (mmol/L)||Standard Deviation|Mean
2815003|NCT00419666|Secondary|Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56|Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.|From baseline (Day 0) up to Day 56|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||milligrams per deciliter (Mg/dL)||Standard Deviation|Mean
2815004|NCT00419666|Primary|Time at Which Maximum Concentration (Cmax) Occurred (Tmax)|Tmax is the time to reach maximum concentration and was reported for calcitriol.|Day 0 (Baseline), Day 21|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||hours||Full Range|Median
2815005|NCT00419666|Primary|Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])|The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.|0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21|Safety population consisted all participants in the ITT population who had applied the study medication at least once.|||pg.h/mL||Standard Deviation|Mean
2815006|NCT00419666|Primary|Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])|The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.|0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||Picograms. hours per millilitre(pg.h/mL)||Standard Deviation|Mean
2815007|NCT00419666|Primary|The Observed Peak Drug Concentration (Cmax) of Calcitriol|Cmax of calcitriol was reported.|Day 0 (Baseline), Day 21|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||pg/mL||Standard Deviation|Mean
2815008|NCT00419666|Primary|Trough Plasma Levels (Ctrough) of Calcitriol|Trough plasma levels (Ctrough) of calcitriol was reported.|Day 0 (Baseline), Day 14, Day 21, and Day 56|Safety population consisted of all participants in the ITT population who had applied the study medication at least once.|||Picograms Per Millilitre (pg/mL)||Standard Deviation|Mean
2815009|NCT00419562|Secondary|Rate of Type 1 Diabetes in Secondary Stratum (Stratum 3+4) When Treated With Oral Insulin Versus Placebo|Secondary outcome is reported as the rate of type 1 diabetes per year among secondary stratum 3+4; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up.|Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years|Combine stratum 3 (mIAA Confirmed, ICA Not Confirmed, ICA512+ OR GAD65ab+, high functioning beta cells) and stratum 4 (mIAA Confirmed, ICA Not Confirmed, ICA512+ OR GAD65ab+, low functioning beta cells)|||Proportion with diabetes/year||95% Confidence Interval|Number
2815010|NCT00419562|Secondary|Rate of Type 1 Diabetes Per Year in Secondary Stratum (Stratum 2) When Treated With Oral Insulin Versus Placebo|Secondary outcome is reported as the rate of type 1 diabetes per year among secondary stratum 2; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up.|Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years|Stratum 2: mIAA Confirmed, (ICA Confirmed) OR (ICA Not Confirmed AND ICA512+ AND GAD65ab+), low functioning beta cells|||Proportion with diabetes/year||95% Confidence Interval|Number
2815011|NCT00419562|Primary|Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo|Primary outcome is reported as the rate of type 1 diabetes per year among the primary stratum; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up.|Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years||||Proportion with diabetes/year||95% Confidence Interval|Number
2815012|NCT00419445|Primary|To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid).|The proportion of subjects with Treatment Emergent Adverse Events.|Baseline to study completion||||% of subjects|||Number
2815071|NCT00418977|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year||||inches||Standard Deviation|Mean
2815072|NCT00418964|Secondary|Percentage Distal Femoral Bone Mineral Density (BMD)Decrease|% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery|1 year|||||||
2815013|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.|Study entry through 12 months|Of the 190 subjects beginning the study, 49 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 12 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.|||percentage of subjects|||Number
2815014|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.|Study entry through 6 months|Of the 190 subjects beginning the study, 139 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 6 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.|||percentage of subjects|||Number
2815015|NCT00419393|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.|||number of subjects|||Number
2815016|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.|||number of subjects|||Number
2815017|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.|||number of subjects|||Number
2815018|NCT00419380|Secondary|Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.|Outcome measure data table represents the absence of drainage at day- 14|14 days||||Ear|||Number
2815019|NCT00419380|Primary|Patency of the Tympanostomy Tube at the Day-14 Visit.||14 days|Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis.|||Ear|||Number
2815020|NCT00419341|Other Pre-specified|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.|||local reactions per infusion|Participants||Number
2815021|NCT00419341|Other Pre-specified|Rate of All AEs by Relatedness and Seriousness|The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.|||AEs per infusion|Participants||Number
2815022|NCT00419341|Other Pre-specified|Minimum Concentration (Cmin) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||g/L||Standard Deviation|Mean
2815023|NCT00419341|Secondary|Tmax at Steady State|Timepoint of maximum concentration (Cmax)|Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||days||Full Range|Median
2815024|NCT00419341|Secondary|Maximum Concentration (Cmax) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||g/L||Standard Deviation|Mean
2815025|NCT00419341|Secondary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Every 4 weeks, throughout the 12-month efficacy period|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||g/L||Standard Deviation|Mean
2815073|NCT00418964|Primary|International Knee Documentation Committee (IKDC)Knee Form 2000 Score|It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.|1 year||||Score on a scale||Standard Deviation|Mean
2815026|NCT00419341|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days per subject year|Participants||Number
2815027|NCT00419341|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days|||Number
2815028|NCT00419341|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days per subject year|Participants||Number
2815029|NCT00419341|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||days|||Number
2815030|NCT00419341|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.|||days per subject year|Participants||Number
2815031|NCT00419341|Secondary|Number of Infection Episodes (Serious and Non-serious)|Total number of infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.|||infections|||Number
2815032|NCT00419341|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.|||infection episodes per subject year|Participants|95% Confidence Interval|Number
2815033|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (PPE Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements.|||SBIs per subject year|Participants||Number
2815034|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (ITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|For the duration of the study, up to 15 months|The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period.|||SBIs per subject year|Participants||Number
2815035|NCT00419341|Primary|Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)|Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03_002CR [NCT00168025] or ZLB05_006CR [NCT00322556]).|Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment|The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.|||days*g/L||Standard Deviation|Mean
2815036|NCT00419341|Primary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.|||SBIs per subject year|Participants||Number
2815039|NCT00419263|Secondary|Change From Baseline to Day 9 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 192 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
2815040|NCT00419263|Secondary|Change From Baseline to Day 5 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 96 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
2815041|NCT00419263|Secondary|Change From Baseline to Day 3 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 48 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
2815042|NCT00419263|Secondary|Change From Baseline to Day 2 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 24 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||log10(TCID50/mL)||Full Range|Median
2815043|NCT00419263|Secondary|Time to Resumption of Ability to Perform Usual Activities|The time to resumption of a subject's self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||Days||95% Confidence Interval|Median
2815044|NCT00419263|Secondary|Time to Resolution of Fever|The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.|||Hours||95% Confidence Interval|Median
2815045|NCT00419263|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.|Up to 14 days|The intent-to-treat infected (ITTI) population included all randomized subjects who received study drug and had proven influenza by culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Of the 318 subjects in the ITTI population, one subject had insufficient data to determine Time to Alleviation of Symptoms.|||Hours||95% Confidence Interval|Median
2815086|NCT00418886|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||weeks||95% Confidence Interval|Median
2815046|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 10mg/Day|The efficacy variable that was compared in the biomarker analysis are PFS & OS within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||months||95% Confidence Interval|Median
2815047|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit (Median PFS and OS by PTEN ) on Everolimus (RAD001) 70mg/Week|The efficacy variable that was compared in the biomarker analysis are PFS & OS within the Everolimus (RAD001) 70mg/Week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||months||95% Confidence Interval|Median
2815048|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 10mg/Day|The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||percentage of participants||95% Confidence Interval|Number
2815049|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit (DCR by PTEN ) on Everolimus (RAD001) 70mg/Week|The efficacy variable that was compared in the biomarker analysis is DCR within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: PTEN loss (imunohistochemistry, IHC), phosphoAKT (IHC), phosphoS6 (IHC), and p53 (IHC). From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||percentage of participants||95% Confidence Interval|Number
2815050|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS) on Everolimus (RAD001) 10mg/Day|The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||months||95% Confidence Interval|Median
2815051|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit (Median PFS and OS by KRAS ) on Everolimus (RAD001) 70mg/Week|The efficacy variable that was compared in the biomarker analysis are Median progression free survival (PFS) and overall survival (OS) within the Everolimus (RAD001) 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||months||95% Confidence Interval|Median
2815052|NCT00419159|Secondary|Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day|The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 10mg/day arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||percentage of participants||95% Confidence Interval|Number
2815053|NCT00419159|Secondary|Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week|The efficacy variable compared in this biomarker analysis is disease control rate (DCR) within the 70mg/week arm in the analysis not adjusted for prognostic factors: from archival tumor tissue (and additionally from a biopsy at a metastatic site, if available), collected during screening: KRAS gene mutation. From blood plasma, collected at screening then on day 1 at cycles 2, 3 and 4, and at the end of treatment: blood lactate dehydrogenase (LDH) isoenzyme fractionation and serum levels of sVEGFR2, bFGF, PLGF and VEGF.|Screening and Day 1 of cycles 2, 3, 4 and end of treatment|FAS|||percentage of participants||95% Confidence Interval|Number
2815054|NCT00419159|Secondary|Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment.|From the first day of treatment until 28 days after discontinuation of study treatment|Safety set analysis|||Participants|||Number
2815055|NCT00419159|Secondary|Overall Survival (OS)|Overall survival defined as the time from date of first study treatment to the date of death due to any cause.|Every 3 months|Overall Survival [OS] was analyzed in Full Analysis Set [FAS].|||Months||95% Confidence Interval|Median
2815056|NCT00419159|Secondary|Progression-free Survival (PFS)|Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause.|Imaging every 8 weeks|Progression- Free Survival (PFS) was analyzed in Full Analysis Set [FAS].|||Months||95% Confidence Interval|Median
2815057|NCT00419159|Primary|The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.~Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above)"|Imaging every 8 weeks|Full Analysis Set|||Participants|||Number
2815058|NCT00419159|Primary|Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.~Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response)."|Imaging every 8 weeks|Per Protocol Set|||Percentage of participants||95% Confidence Interval|Number
2815059|NCT00419120|Secondary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.|periodically within first 12 months as well as during long term follow up out to 5 years||||participants|||Number
2815060|NCT00419120|Primary|Number of Responders as Assessed by Compliance|Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders|12 months|The analysis population of the primary outcome measure is the all implanted population (Intent to Treat - ITT). There was no imputation of analysis measures.|||participants|||Number
2815061|NCT00419094|Secondary|The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.|112 days|Of the 57 (Keppra 1000 mg) subjects randomized, 54 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population.|||proportion of subjects||95% Confidence Interval|Number
2815062|NCT00419094|Secondary|The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.|||proportion of subjects||95% Confidence Interval|Number
2815063|NCT00419094|Secondary|The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.|||proportion of subjects||95% Confidence Interval|Number
2815064|NCT00419094|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Primary Efficacy analysis was conducted for the Keppra XR 2000 mg/day group only.|||proportion of subjects||95% Confidence Interval|Number
2815065|NCT00419003|Other Pre-specified|Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects|Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups|24, 48, or 72-hrs|||||||
2815066|NCT00419003|Primary|Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.|24 Hours||||scores on a scale||95% Confidence Interval|Mean
2815067|NCT00418977|Primary|Body Mass Index (BMI) Z-score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator|up to 1 year||||z-score||Standard Deviation|Mean
2815068|NCT00418977|Secondary|BMI Percentile|Body Mass Index (BMI) percentile. This is not a primary outcome variable.|up to 1 year||||percentile||Standard Deviation|Mean
2815199|NCT00418184|Secondary|Blood Monoamines Metabolism||on week 0, 15|||||||
2815074|NCT00418951|Primary|Number of Participants With Invasive Fungal Infection|Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.|35 days from the start of therapy for induction participants and 42 days for salvage participants.|Outcome evaluability required at least two doses of study drug.|||participants|||Number
2815075|NCT00418938|Secondary|Duration of Response|Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||months||95% Confidence Interval|Median
2815076|NCT00418938|Secondary|Disease Control|Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||% of participants||95% Confidence Interval|Number
2815077|NCT00418938|Secondary|Time to Progression|Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.|||months||95% Confidence Interval|Median
2815078|NCT00418938|Secondary|Time to Response|Time to response is defined as time from the date of randomization to the date of first confirmed objective response|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||months||Inter-Quartile Range|Median
2815079|NCT00418938|Secondary|Objective Response Rate|Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.|||% of patients||95% Confidence Interval|Number
2815080|NCT00418938|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.|||months||95% Confidence Interval|Median
2815081|NCT00418938|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.|||months||95% Confidence Interval|Median
2815082|NCT00418886|Secondary|Longitudinal Analysis of Average Symptom Burden Index (ASBI) Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the six symptom visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)."|ASBI is a score taken from the Lung Cancer Symptom Scale (LCSS) questionnaires administered every 3 weeks after randomisation||||mms on a visual analogue scale||Standard Error|Least Squares Mean
2815083|NCT00418886|Secondary|Longitudinal Analysis of Lung Cancer Symptom Scale (LCSS) Total Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all nine visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)"|LCSS questionnaires are to be administered every 3 weeks after randomisation||||mms on a visual analogue scale||Standard Error|Least Squares Mean
2815084|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Average Symptom Burden Index (ASBI) Score|Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The ASBI is derived from 6 of LCSS's 9 items|ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomisation||||weeks||95% Confidence Interval|Median
2815085|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score|TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.|LCSS questionnaires are to be administered every 3 weeks after randomisation||||weeks||95% Confidence Interval|Median
2815180|NCT00418262|Primary|Pittsburg Side-Effects Scale: Trouble Sleeping|Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.|12 months or study duration|One subject participating in the RCT did not participate in the open label|||units on a scale||Standard Deviation|Mean
2815200|NCT00418184|Secondary|Plasma and Red Blood Cells Fatty Acid Profile||on weeks 0,15|||||||
2815087|NCT00418886|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||Percentage of Participants|||Number
2815088|NCT00418886|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 6 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||Percentage of Participants|||Number
2815089|NCT00418886|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||months||95% Confidence Interval|Median
2815090|NCT00418886|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||weeks||95% Confidence Interval|Median
2815091|NCT00418886|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression||||weeks||95% Confidence Interval|Median
2815092|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815093|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815094|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815095|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815096|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815097|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815098|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815099|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815100|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815201|NCT00418184|Secondary|Child Health Questionnaire (CHQ)- Parent-completed Form 50||on weeks 0,15|||||||
2815101|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815102|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815103|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815104|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815105|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815106|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815107|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815108|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815109|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis."|||Percent Change||95% Confidence Interval|Least Squares Mean
2815110|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseine and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815111|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815112|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815113|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2815114|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12||Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Participants|||Number
2815181|NCT00418262|Primary|Pittsburg Side-Effects Scale: Loss of Appetite|"Loss of Appetite~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
2815202|NCT00418184|Secondary|Test of Variables of Attention (TOVA)||on weeks 0,15|||||||
2815115|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6||Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Participants|||Number
2815116|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12||Week 12|"Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis."|||Participants|||Number
2815117|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||Week 6|"Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis."|||Participants|||Number
2815118|NCT00418834|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|"Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis."|||Percent Change||95% Confidence Interval|Least Squares Mean
2815119|NCT00418834|Primary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis."|||Percent Change||95% Confidence Interval|Least Squares Mean
2815120|NCT00418717|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12.|7 days after week 4 and 7 days after week 12|The analysis population was the Pharmacokinetic (PK) subset, which included all patients who completed the 25 mg BW dose treatment period, received at least 1 dose of 50 mg QW and elected to participate in the PK assessment. Data on observed cases: 18 patients from ETN 25 mg BW (week 4) and 17 patients from ETN 50 mg QW (week 12).|||ug*Day/mL||Standard Deviation|Mean
2815121|NCT00418717|Primary|Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.|DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).|weeks 4 and 12|The analysis population was modified intent to treat (mITT), which included all patients who completed the 25 mg BW dose treatment period and received at least 1 dose of 50 mg OW. Data on observed cases: 41 patients from ENT 25 mg BW (week 4) and 39 patients from ETN 50 mg OW (week 12).|||units on scale||Standard Deviation|Mean
2815122|NCT00418691|Primary|Patient Cognitive Test Scores at End of Treatment Period|For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).|Baseline to end of Week 4 treatment period|||||||
2815123|NCT00418691|Primary|Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score|"'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow trail made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean)."|Baseline to 4-5 weeks on study medication|Analysis were per protocol. The z-score reflects how many standard deviations above or below the population mean a raw score is for each participant.|||z-scores||Standard Deviation|Mean
2815124|NCT00418665|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions during the treatment period|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2815125|NCT00418665|Secondary|Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period and post-treatment follow-up (up to 21 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2815126|NCT00418665|Secondary|Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2815182|NCT00418262|Primary|Pittsburg Side-Effects Scale: Hallucinations|"Hallucinations~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
2815127|NCT00418665|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.|Treatment period through interim follow-up visit (up to 16 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2815128|NCT00418574|Secondary|Time Course of Immunoresponse|Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).|at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)|Participants who received abagovomab (evaluable population)and have baseline serum sample: 576 at baseline; 538 at week 10 after first dose intake; 449 at the final study visit|||ng/ml||Full Range|Median
2815129|NCT00418574|Secondary|Safety|"Safety was analyzed in all patients who received at least 1 dose administration.~Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed."|Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose|Safety population (i.e. All randomized patients who received at least one dose treatment administration)|||participants|||Number
2815130|NCT00418574|Secondary|Overall Survival|2 years survival rate|2 years|intention to treat (ITT) population (i.e. all randomized patients)|||Percentage of participants|||Number
2815131|NCT00418574|Primary|Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)|The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.|Every 12 weeks up to recurrence or up to 3 months after last administered dose|intention to treat (ITT) population (i.e. all randomized patients)|||days||95% Confidence Interval|Median
2815132|NCT00418561|Other Pre-specified|Physical Examination Results|Physical examination included general appearance, skin, head, ears, eyes, nose and throat, lymph nodes, heart, lungs, abdomen, extremities/joints, hip, neurological, mental status and, if appropriate, breasts, external genitalia, pelvic and rectal, and in addition weight, height and head circumference were recorded.|Baseline up to Week 26|Physical examination results were not summarized since data were collected in participant’s listing only as planned.||||||
2815133|NCT00418561|Primary|Arylsulfatase A (ASA) Activity in Leukocytes||Pre-dose and post-dose at 24 hours on Day 0 and at Weeks 8 and 26|Data were not available to report as ASA activity in leukocytes was presented graphically, as per planned analysis.||||||
2815134|NCT00418561|Primary|Maximum Plasma Drug Concentration (Cmax) of Recombinant Human Arylsulphatase A (rhASA)||Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours on Day 0, 40 minutes post-dose at Week 4, Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours at Week 8|Due to quick disappearance of rhASA from plasma, rhASA levels were not possible to report.||||||
2815135|NCT00418561|Other Pre-specified|Change From Baseline in Amplitude at Week 26|Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; APB=abductor pollicis brevis; EDB=extensor digitorum brevis.|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||millivolts||Standard Deviation|Mean
2815136|NCT00418561|Other Pre-specified|Change From Baseline in Neurofilament Proteins (NFP), Glial Fibrillary Acidic Protein (GFAP) and Tauprotein in Cerebrospinal Fluid (CSF) at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||nanogram/milliliter||Standard Deviation|Mean
2815137|NCT00418561|Other Pre-specified|Change From Baseline in Chitotriosidase at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||nanomole/hour/milliliter||Standard Deviation|Mean
2815138|NCT00418561|Other Pre-specified|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings were considered as clinically significant at the discretion of investigator.|Baseline up to Week 26|ITT|||participants|||Number
2815139|NCT00418561|Other Pre-specified|Number of Participants With Abnormal Findings in Urine Analysis|The parameters analyzed in urine were albumin/protein, glucose, leucocytes, acetoacetate/ketones, nitrite and pH. Urine analysis findings were considered abnormal as judged by the investigator.|Baseline up to Week 26|ITT|||participants|||Number
2815140|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Hematology|"Number of participants with at least 1 shift from baseline to Week 26 are reported.~Abbreviations: Abs=Absolute count; ERCS=Erythrocytes; MCHC=Mean corpuscular hemoglobin concentration; MCH=Mean cell hemoglobin."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."|||participants|||Number
2815141|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Genotyping|"Number of participants with at least 1 shift from baseline to Week 26 are reported.~Abbreviations: CSF=Cerebrospinal fluid; NFP=Neurofilament proteins."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."|||participants|||Number
2815142|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Coagulation|Number of participants with at least 1 shift from baseline to Week 26 are reported. The shift reported below for Cohort 1 was from low level at baseline to low level at Week 26.|Baseline up to Week 26|ITT. Data for Cohorts 2 and 3 were not reported since there were no participants with shift from baseline to Week 26 in coagulation evaluations.|||participants|||Number
2815203|NCT00418184|Secondary|Clinical Global Impression of Improvement||on weeks 0,15|||||||
2815204|NCT00418184|Secondary|Strength and Difficulties Questionnaires - Home Version||on weeks 0,15|||||||
2815143|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Biochemistry|"Number of participants with at least 1 shift from baseline to Week 26, are reported.~Abbreviations: ALT=Alanine transaminase; CK=Creatine kinase; AP=Amyloid P component; LDH=Lactate dehydrogenase."|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.|||participants|||Number
2815144|NCT00418561|Secondary|Change From Baseline in Paediatric Evaluation of Disability Inventory (PEDI) Scores at Week 26|PEDI is used for the clinical evaluation of functional capabilities, performance and changes in functional skills in children with disabilities. It consisted of 20 items scored on a scale from 0 (total assistance) to 5 (independent). Total score ranged from 0-100 with higher scores indicating better functioning. None, child, rehab, extensive are items in 3 domains (self-care, mobility and social functioning).|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||units on a scale||Standard Deviation|Mean
2815145|NCT00418561|Secondary|Number of Participants With Shift From Baseline to Week 26 in Magnetic Resonance Imaging (MRI)-Loes Scores|Loes scoring system is used to grade the demyelinating abnormalities on brain MRI. A total of 17 locations of the brain were scored from 0 (normal appearance) to 2 (dense appearance). The total score ranged from 0 to 34 with a score of 14 or greater being considered severe. Number of participants with any shift of score between 0 to 2 for each of the 17 locations (Parieto Occipital [PO]-Periventricular [P], Central [C], Subcortical [Sc]; Anterior Temporal [AT]-P, C, Sc; Frontal [F]-P, C, Sc; Corpus Callosum [CC]-Splenium [S], Genus [G]; Projection Fibers [PF]-Capsular interna [CI] ant, CI post, Brainstem [B]; Cerebellum [Cb]-Cortex, Atrophy; Basal Ganglia [BG]-BG, Thalamus [T]; Cerebral Atrophy [CA]-CA), are only reported.|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.|||participants|||Number
2815146|NCT00418561|Secondary|Number of Participants Who Had Undergone Nerve Biopsy and Had a Normal Nerve at Both Baseline and Week 26||Baseline, Week 26|ITT.|||participants|||Number
2815147|NCT00418561|Secondary|Change From Baseline in Nerve Conduction Velocity at Week 26|"An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction and units are expressed in meters per second.~Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; FH=fibular hemimelia; L LM=left lateral medial; R LM=right lateral medial; MC=medial collateral."|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."|||meters per second||Standard Deviation|Mean
2815148|NCT00418561|Primary|Change From Baseline in Mullen's Scales of Early Learning at Week 26|Mullen's Scales of Early Learning is used to assess performance and learning ability in young children. The scale consisted of 144 items that had specific scoring criteria for each item. The scores were converted to T-scores with a decrease in score indicating worsening of disease. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT|||percent (%) change||95% Confidence Interval|Mean
2815149|NCT00418561|Primary|Number of Participants With Shift From Baseline to Week 26 in Sulfatide Levels in Urine|Number of participants with shifts between negative (value=0) and positive (value=1) values in urine sulfatide levels from baseline at Week 26 is reported.|Baseline up to Week 26|ITT. Here, the number of participants analyzed are the participants evaluable for this outcome.|||participants|||Number
2815150|NCT00418561|Primary|Change From Baseline in Cerebrospinal Fluid (CSF) Sulfatide at Week 26|Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT|||percent (%) change||95% Confidence Interval|Mean
2815151|NCT00418561|Primary|Change From Baseline in Gross Motor Function Measure (GMFM) at Week 26|GMFM was measured using GMFM-88 item scores and summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) and 264 (maximum). The decrease in GMFM score over time indicates worsening of disease over time. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT|||percent (%) change||95% Confidence Interval|Mean
2815152|NCT00418561|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship. TEAEs were AEs occurred after study drug administration that were absent before treatment or that worsened relative to pre-treatment state, up to Week 28 until evaluation (when last cohort had 26-week evaluation and data management performed within 4 weeks) completed.|From study drug administration up to Week 28|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.|||participants|||Number
2815153|NCT00418522|Other Pre-specified|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Using the FAS yielded supplemental analyses for the primary efficacy endpoint.|||percent||Standard Deviation|Mean
2815154|NCT00418522|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire|Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.|Baseline, Week 26|||||||
2815183|NCT00418262|Primary|Pittsburg Side-Effects Scale: Socially Withdrawn|"Socially Withdrawn~Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation"|12 months or study duration|One subject in the RCT did not enroll in the open label study|||units on a scale||Standard Deviation|Mean
2815205|NCT00418184|Secondary|Strength and Difficulties Questionnaires - School Version||on weeks 0,15|||||||
2815155|NCT00418522|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 26|BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with BMI measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.|||kg/m2||Standard Deviation|Mean
2815156|NCT00418522|Secondary|Change From Baseline in Body Weight at Week 26|Body weight value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with body weight measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.|||kg||Standard Deviation|Mean
2815157|NCT00418522|Secondary|Number of Nocturnal Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug.|||events|||Number
2815158|NCT00418522|Secondary|Crude Hypoglycemic Event Rate|crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||events / subject-months|||Number
2815159|NCT00418522|Secondary|Number of Total Subject Months of Treatment|Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||subject months|||Number
2815160|NCT00418522|Secondary|Number of Total Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||events|||Number
2815161|NCT00418522|Secondary|Number of Subjects With Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.|||participants|||Number
2815162|NCT00418522|Secondary|Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26|SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.|||mg/dL||Standard Deviation|Mean
2815163|NCT00418522|Secondary|Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26|24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.|||mg/dL||Standard Deviation|Mean
2815164|NCT00418522|Secondary|Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26|CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (adiponectin and ApoB) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/mL||Standard Deviation|Mean
2815165|NCT00418522|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26|CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (hs-CRP, leptin, and spot urine microalbumin) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/L||Standard Deviation|Mean
2815166|NCT00418522|Secondary|Change From Baseline in Lipids at Week 26|Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with lipids data at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/dL||Standard Deviation|Mean
2815167|NCT00418522|Secondary|Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26|Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS = all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with postprandial blood glucose measurements as measured by 8-point profiles at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/dL||Standard Deviation|Mean
2815168|NCT00418522|Secondary|Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26|Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting and postprandial blood glucose measurements determined by standardized meal tolerance tests at Baseline and Week 26: n=inhaled human insulin, insulin glargine.|||mg/dL||Standard Deviation|Mean
2815169|NCT00418522|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26|Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting plasma glucose at Baseline and Week 26: inhaled human insulin n=202, insulin glargine n=189.|||mg/dL||Standard Deviation|Mean
2815170|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26|Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 8.0% at Week 26: inhaled human insulin n=162, insulin glargine n=158.|||percentage of participants|||Number
2815171|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 7.0% at Week 26: inhaled human insulin n=127, insulin glargine n=90.|||percentage of participants|||Number
2815172|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 6.5% at Week 26: inhaled human insulin n=72, insulin glargine n=42.|||percentage of participants|||Number
2815173|NCT00418522|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|Per protocol (PP)=Full Analysis Set (FAS) subjects (i.e., had >=1 study drug dose and >=1 post-baseline measurement) with >=12 weeks treatment and no major protocol violation. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c values at Baseline and Week 26: inhaled human insulin n=154, insulin glargine n=157.|||percent||Standard Deviation|Mean
2815174|NCT00418379|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.~Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 33.8 days) of Year 3|Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3.|||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
2815175|NCT00418314|Secondary|All Cause, Cardiovascular and Heart Failure Hospitalization||12 months||||participants|||Number
2815176|NCT00418314|Secondary|All-cause, Cardiovascular and Heart Failure Mortality;||12 months|Per protocol|||participants|||Number
2815177|NCT00418314|Primary|Heart Failure Clinical Composite Score|The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.|12 months||||participants|||Number
2815178|NCT00418262|Secondary|Compare Growth While on Atomoxetine With Growth Before Entry Into Study.|Height measured in centimeters at the time of each visit as part of the vital signs.|12 months or study duration|Measurements of height were not consistently obtained on all subjects.|||cm||Standard Deviation|Mean
2815179|NCT00418262|Secondary|Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.|Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.|12 months or study duration|ADHD Parent Rating Scale|||units on a scale||95% Confidence Interval|Mean
2815237|NCT00417976|Secondary|Response Rates Defined by RECIST 1.0|The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients|6 months||||patients|||Number
2815206|NCT00418184|Secondary|Conners Rating Scale - Home Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.|||Scores on a scale||Standard Error|Mean
2815207|NCT00418184|Primary|Conners Rating Scale - School Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.|||Scores on a scale||Standard Error|Mean
2815208|NCT00418145|Secondary|Improvement Using Targeted Neurological Deficits (TND).||Day 28 and day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
2815209|NCT00418145|Secondary|Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.||Day 28 and day 90 and day 365|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
2815210|NCT00418145|Secondary|Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.||Day 28 and day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
2815211|NCT00418145|Primary|Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.|There is no data analysis for this study|Day 28 and Day 90|Data is also no longer accessible. Data was with biostatistician who no longer has data.||||||
2815212|NCT00418093|Secondary|Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.|The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported|Toxicities were assessed every cycle and for up to 30 days after being removed from the trial|All patients enrolled|||percentage of participants|||Number
2815213|NCT00418093|Secondary|Overall Survival|Duration of time participants are alive after enrolling on the study. Assessed by clinical records|Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months|All patients enrolled|||weeks||95% Confidence Interval|Median
2815214|NCT00418093|Secondary|Progression Free Survival|Time participant remains free of progression of her disease. Evaluated by RECIST criteria|Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months|19|||weeks||95% Confidence Interval|Median
2815215|NCT00418093|Primary|Partial Response Rate|Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria|Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)||||percentage of patients on study|||Number
2815216|NCT00418028|Secondary|Progression Free Survival|Progression Free Survival is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies for any reason.|Time (in months) from the moment the patient starts the study treatment to the date of progressive disease assessed up to 84 months.||||Months||95% Confidence Interval|Median
2815217|NCT00418028|Secondary|Clinical Benefit|"A patient experiences a Clinical Benefit if the following is satisfied:~Criterion: The patient has Complete response, Partial Response or Stable Disease and it continues during more than 3 months."|"Months from CR,PR or SD (the first one) until Progression date, new treatment or last contact date."|Only 179 patients had tumor evaluation data.|||Participants|||Count of Participants
2815218|NCT00418028|Secondary|Overall Survival|An event is defined as death. A patient is censored if she does not die. The censoring date is last contact date.|Time to survival is the number of months from the study treatment start date to the date of death, assessed up to 100 months.||||Months||95% Confidence Interval|Median
2815219|NCT00418028|Secondary|Time to Treatment Failure|"Time to treatment failure (TTF) is defined as the time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria.~If a patient did not end the treatment, it is censored. The censoring date is the date of the last dose received."|Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria, assessed up to 72 months.|This outcome only was analyzed in the Per Protocol Population (182 patients).|||Months||95% Confidence Interval|Median
2815220|NCT00418028|Secondary|Response Duration|"Response duration is computed for all patients with Partial Response or Complete Response, during the treatment period, as the time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first.~A patient is censored if she does not progress or die. In these cases Response duration is computed as the time from the moment the Partial or Complete Response is reported to the last contact date."|Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first, assessed up to 72 weeks.|From 192 patients (95 in Arm A and 97 in Arm B), 61 patients had Complete Response or Partial Response (30 in Arm A and 31 in Arm B).|||Months||95% Confidence Interval|Median
2815238|NCT00417976|Primary|Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy||6 months||||percent of patients|||Number
2815221|NCT00418028|Secondary|Response Rate|Response was evaluated using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), every 3 cycles of chemotherapy (each cycle lasts 3 weeks) and at the end of treatment (at 21 weeks from the start of treatment).|Through the study treatment, an average of 5 months.|There were 95 patients in Arm A and 97 patients in Arm B. There were 13 patients without response evaluation (9 in Arm A and 4 in Arm B).|||Participants|||Count of Participants
2815222|NCT00418028|Primary|Time to Progression|Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|After 1 year from the treatment start day.|A total of 192 patients (95 in Arm A and 97 in Arm B) were considered for this analysis but 36 were censored (23 in Arm A and 13 in Arm B). Patients censored are those that did not progress or die due to progressive disease during the study treatment.|||months||95% Confidence Interval|Median
2815223|NCT00418015|Primary|Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention|Visual analog pain scale (0 to 100) at 1st request for supplemental analgesia|VAS at analgesia request|Analysis population per protocol.|||Units on a scale||Inter-Quartile Range|Median
2815224|NCT00418015|Secondary|Subjects With Pruritus at 24 Hours Post Morphine|Subjects reporting pruritus in the first 24 hours post cesarean delivery|24 hours post cesarean delivery||||participants|||Number
2815225|NCT00418015|Secondary|Severity of Pruritus Following Fentanyl|Severity of pruritus during labor analgesia|Labor analgesia||||participants|||Number
2815226|NCT00418015|Primary|Duration of Intrathecal Analgesia Following Cesarean Delivery|Time until request for supplemental analgesia following intrathecal morphine/fentanyl for cesarean delivery|0 to 72 hours following cesarean delivery|Subjects that received fentanyl and morphine for postpartum analgesia after planned cesarean delivery were analyzed per protocol.|||Hours||Inter-Quartile Range|Median
2815227|NCT00418015|Primary|Duration of Intrathecal Fentanyl Analgesia|Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery|Time (0-1440 minutes) to first analgesia request|Laboring parturients that received intrathecal fentanyl (25 micrograms) for initiation of labor analgesia were evaluated for this outcome per protocol.|||Minutes||95% Confidence Interval|Median
2815228|NCT00417989|Secondary|Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy|Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks||||participants||Standard Deviation|Mean
2815229|NCT00417989|Secondary|Quality of Life - Short Form-36 (SF-36v2™), General Health|Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks|Adult population (18 and older) only|||Participants||Standard Deviation|Mean
2815230|NCT00417989|Secondary|Health Economic Outcome|Health Economic Outcome was a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors. This analysis was restricted to only adult subjects (Age 19 to 70), therefore the number of participant analyzed is different. The goal was to estimate the long term cost effectiveness of Sensor Augmented Pump therapy from the perspective of the US health care system. The unit of measurement was cost in $ per year for sensor augmented pump group and MDI group. No formal statistical analysis was planned or performed|Baseline and 52 weeks||||$|||Number
2815231|NCT00417989|Secondary|Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score|Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 weeks|Adult population (18 and older) only|||participants||Standard Deviation|Mean
2815232|NCT00417989|Secondary|Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks||||mmol/dl*min||Standard Deviation|Mean
2815233|NCT00417989|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks||||mmol/dl*min||Standard Deviation|Mean
2815234|NCT00417989|Secondary|Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.|Baseline and 52 weeks||||participants|||Number
2815235|NCT00417989|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.|Baseline and 52 weeks||||number of events|||Number
2815236|NCT00417989|Primary|Change in A1c From Baseline to 52 Weeks|Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 52 weeks||||Percent glycated hemoglobin||Standard Deviation|Mean
2815239|NCT00417963|Secondary|Number of Participants Experiencing Restenosis|Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.|12 months after implantation|Number of participants experiencing restenosis through 12 months from implantation.|||number of participants|||Number
2815240|NCT00417963|Secondary|Number of Participants Experiencing Lesion Success|number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.|at time of implantation|number of participants with lesion success defined as <50% residual stenosis.|||number of participants|||Number
2815241|NCT00417963|Secondary|Number of Participants Experiencing Device Success|Number of participants with successful delivery and deployment of device with <50% residual stenosis.|at time of implantation|Number of participants with successful delivery and deployment of device with <50% residual stenosis.|||number of participants|||Number
2815242|NCT00417963|Secondary|Number of Participants Experiencing Stroke Related Neurologic Deficit|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.|30 days from implantation|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure.|||number of participants|||Number
2815243|NCT00417963|Secondary|Number of Patients Experiencing Access Site Complications|Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.|30 days following implantation|Number of participants experiencing access site complications requiring blood transfusion (>1 unit) or open repair.|||Number of participants|||Number
2815244|NCT00417963|Secondary|Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)|Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation|12 months from implantation|Number of participants experiencing target lesion revascularization up to 12 months from implantation|||Number of participants|||Number
2815245|NCT00417963|Primary|Percentage of Patients Experiencing Major Adverse Events (MAE)|A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.|365 days from implantation|All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population.|||percentage of participants||95% Confidence Interval|Mean
2815246|NCT00417885|Secondary|Clinical Benefit Rate (CBR)|The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.|||rate|||Number
2815247|NCT00417885|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
2815248|NCT00417885|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.|From start of study treatment until death|ITT. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
2815249|NCT00417885|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer|Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
2815250|NCT00417885|Secondary|Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 1 of every other cycle (8 weeks)|Analyses on OR were performed for subjects who received at least 1 dose of study medication.|||participants|||Number
2815251|NCT00417885|Primary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death|Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.|||weeks||Standard Deviation|Mean
2815252|NCT00417859|Secondary|Number of Participants With Dislocation|count of numbers of dislocated implants.|5years||||Participants|||Count of Participants
2815253|NCT00417859|Secondary|Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures|Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.|5years|data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)|||score on a scale||Standard Deviation|Mean
2815270|NCT00417482|Secondary|Mini Mental State Exam (MMSE)|The MMSE assesses cognition. Scores range from 0-30, with higher scores indicating better cognition. For each subject, the change in MMSE between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in MMSE over time.|Phase B, weeks 1-16 (study weeks 16-32)|MMSE data were missing for 2 subjects in the placebo group and 1 subject in the risperidone group, so the number of subjects in this analysis were 38 (placebo) and 69 (risperidone), for a total of 107.|||units on a scale||Standard Deviation|Mean
2815254|NCT00417859|Primary|EuroQoL Quality of Life Scale (EQ-5D)|"The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T.~Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time."|5years|data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)|||score on a scale||Standard Deviation|Mean
2815255|NCT00417859|Primary|Gait Stride Length|distance in meters of gait stride lenght measured by a data logger with five inertial sensors|5years||||meters||Inter-Quartile Range|Mean
2815256|NCT00417612|Primary|Reduction of Parathyroid Hormone Area Under the Curve (PTHauc) of 20% or Greater|Clinically significant reduction of Mean PTHauc (% decrease >/= 20) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12||||percentage of participants|||Number
2815257|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTH; Percentage Decrease)|Mean PTHauc (% decrease) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12||||participants|||Number
2815258|NCT00417612|Secondary|Serum 1,25 (OH)2D||Measured at baseline and Month 12||||pg/ml||Standard Deviation|Mean
2815259|NCT00417612|Secondary|Serum Intact Fibroblast Growth Factor 23 (FGF23)||Measured at baseline and Month 12||||pg/ml||95% Confidence Interval|Mean
2815260|NCT00417612|Secondary|Percent Change in Urinary Calcium Excretion From Baseline to 1 Year|Percent change in daily urinary calcium excretion, which is calculated the measurements of the calcium in the subject's 24-hr urine collections done at baseline and at the 1 year timepoints|Measured at baseline and Month 12||||percent change||Standard Deviation|Mean
2815261|NCT00417612|Secondary|Bone Scan Severity Score|"99-Tc-methylenediphosphonate bone scans were completed and analyzed using the following scale*: Bone scan severity scale with minimum score of 0 and maximum score of 4 (0 is no disease and 4 is greatest severity of disease).~Appearance of lumbar spine and the sacroiliac region were used as internal references to which all suspected lesions were compared, and scored as follows:~grade 0, normal scan without suspicious lesions grade 1, lesion(s) less intense than normal lumbar spine grade 2, lesion(s) similar in intensity to normal lumbar spine grade 3, lesions more intense than normal lumbar spine but similar to the normal sacroiliac region grade 4, lesions more intense than the normal sacroiliac region.~*devised by nuclear medicine radiologist at Yale New Haven Hospital"|Measured at baseline and Month 12||||units on a scale||Standard Deviation|Mean
2815262|NCT00417612|Secondary|Serum Calcium||Measured at baseline and Month 12||||mg/dl||Standard Deviation|Mean
2815263|NCT00417612|Secondary|Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms.||Measured at baseline and Month 12|Alkaline phosphatase activity was analyzed separately for children (less than 18 years of age) and adults as values varied considerably between these two groups. In other outcome measure modules the paricalcitol group is comprised of 19 participants analyzed which includes adults and children. In this module, the children (2) are their own arm.|||mg/dl||Standard Deviation|Mean
2815264|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement|Mean area under the curve for parathyroid hormone levels (PTHauc) sampled during a 26 hour study period, for Paricalcitol (Active Drug) and Placebo groups at Baseline and Month 12 .|Measured at baseline and Month 12||||nlEq*26hr/ml||Standard Deviation|Mean
2815265|NCT00417482|Secondary|Weight|For each subject, the change in weight in pounds between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in weight over time.|Phase B, weeks 1-16 (study weeks 16-32)|Available data from all randomized subject (N=110) was used in this analysis. Weight measurements were unavailable at one or more time points for 3 subjects in the placebo group and for 6 subjects in the risperidone group.|||pounds||Standard Deviation|Mean
2815266|NCT00417482|Secondary|Physical Self-Maintenance Scale (PSMS)|Physical Self-Maintenance Scale, which ranges from 1 to 30, with higher scores indicating WORSE functioning. For each subject, the change in PSMS between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in PSMS (worse functioning) over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis, with the exception of one placebo subject for whom PSMS data was not available at one time point|||units on a scale||Standard Deviation|Mean
2815267|NCT00417482|Secondary|AIMS|The Abnormal Involuntary Movement Scale (AIMS) assesses signs of tardive dyskinesia, a movement disorder that can occur with prolonged use of antipsychotic medication. The AIMS score ranges from 0 to 35, with higher scores indicating more severe symptoms. For each subject, the change in AIMS score between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in AIMS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110).|||units on a scale||Standard Deviation|Mean
2815268|NCT00417482|Secondary|Extrapyramidal Signs (EPS)|Extrapyramidal signs, also known as Parkinsonian signs, refer to signs of tremor, rigidity, and bradykinesia (slowed movement) that are seen in Parkinson's disease. Assessment of extrapyramidal signs (EPS) were made with the use of the Simpson-Angus scale (which ranges from 1-40) with higher scores indicating more extrapyramidal signs. For each subject, the change in EPS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in EPS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in the analysis (N=110).|||units on a scale||Standard Deviation|Mean
2815269|NCT00417482|Secondary|Treatment Emergent Symptoms Scale (TESS)|The Treatment Emergent Symptom Scale (TESS) assesses 26 somatic symptoms. Total scores range from 0-26, with a score of 0 or 1 for each item. Higher scores indicate more somatic symptoms. For each subject, the change in TESS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in TESS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110)|||units on a scale||Standard Deviation|Mean
2815271|NCT00417482|Secondary|Relapse by Study Week 48|Same definition and criteria as the primary outcome|16-32 weeks in Phase B (32-48 weeks in study)|Randomized subjects in each Arm who had not relapsed or terminated the study by the end of the first 16 weeks of Phase B were analyzed in the second 16 weeks of Phase B using intent to treat (ITT) principles.|||participants|||Number
2815272|NCT00417482|Primary|Relapse by Study Week 32|"A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:~Increase in the Neuropsychiatric Inventory (NPI) core score of 30% or more OR a 5-point increase from the baseline NPI score at the end of Phase A~A score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impression-Change (CGI-C) at any visit."|0-16 weeks in Phase B (16-32 weeks in study)|Analysis was performed as per intention to treat (ITT) principles.|||participants|||Number
2815273|NCT00417417|Other Pre-specified|Brachial Artery Flow-mediated Dilation|Brachial artery flow-mediated dilation in respone to 5 minutes of forearm ischemia|Two weeks following final administration of drug|Per protocol|||percent change||Standard Deviation|Mean
2815274|NCT00417417|Primary|C-Reactive Protein (CRP)|C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.|2 wks following last drug administration|per protocol|||mg/L||Standard Deviation|Mean
2815275|NCT00417274|Primary|Efficacy of Quinacrine, Based on Prostate Specific Antigen (PSA) Response in Patients With Androgen-independent Metastatic Prostate Cancer|Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator's discretion.|End of treatment|Based on clinical judgment|||Participants|||Number
2815276|NCT00417248|Secondary|Overall Survival||18 months|Data for this outcome measure was not collected or analyzed due to the early termination of the study.||||||
2815277|NCT00417248|Primary|Time to Disease Progression (TTP)||18 months|The primary objective for this study was not analyzed due to termination of the study. No participants were on-study for a sufficient period of time to collect or analyze the time to disease progression data.||||||
2815278|NCT00417170|Secondary|Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment|Arterial Compliance is determined by Pulse Wave Analysis measured by a detector placed at the carotid artery while taking ECG and tonometry at the same time. Procedure is repeated for the femoral artery. Pulse Wave data are calculated by dividing distance between 2 arteries by the difference between the rise delay of the distal pulse wave and the R wave of the QRS complex and the rise delay of the proximal pulse wave to the QRS complex. Data analysis used an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2815279|NCT00417170|Secondary|Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment|C-peptide level is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|Baseline and after 12 weeks of treatment|The PD analysis set included all subjects with available PD data and no major protocol deviations with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.|||ng/mL||Standard Error|Least Squares Mean
2815280|NCT00417170|Secondary|Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment|Insulin Concentration is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set included all participants with available PD data and no major protocol deviation with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.|||mU/L||Standard Error|Least Squares Mean
2815281|NCT00417170|Secondary|Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment.|Insulin sensitivity is measured by the hyperglycemic euglycemic clamp procedure where a supine patient has 2 IV lines inserted for sampling blood. Regular human insulin (60mU/m^2 surface area/min) is infused for 120 minutes. Dextrose (20% w/v) is infused to maintain glycemia at < 100 mg/dL and is adjusted based on plasma glucose levels obtained every 5 minutes. Blood for glucose and insulin is taken at specified time intervals. Change from baseline data is analyzed by analysis of variance model including treatment and week as fixed factors, and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.|||mg/kg/min||Standard Error|Least Squares Mean
2815292|NCT00417027|Secondary|Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.|Highest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.|3 hours after initiation of labor analgesia||||participants|||Number
2815282|NCT00417170|Primary|Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment|MBF is measured by Positron Emission Tomography (PET) first at rest, then 45 minutes later, during cold pressor testing (CPT). The patient is placed in the PET scanner and injected with N-13 ammonia as a tracer. PET images are taken to assess myocardial blood flow at rest. After 40 minutes, the patient immerses one hand in ice water and PET images are taken to assess myocardial blood flow at sympathetic activation. Change from baseline data is analyzed by an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.|||mL/g/min||Standard Error|Least Squares Mean
2815283|NCT00417079|Secondary|Pain Response|Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.|from baseline up to 104 weeks (study cut-off)|Pain Response (applies only to patients, in the Intention-To-Treat (ITT) population, with median PPI ≥2 on McGill-Melzack scale and/or mean Analgesic Score ≥10 points at baseline)|||Percentage of participants||95% Confidence Interval|Number
2815284|NCT00417079|Secondary|Time to Pain Progression|"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.~Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)"|from baseline up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of > 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).|||Months||95% Confidence Interval|Median
2815285|NCT00417079|Secondary|PSA (Prostate-Specific Antigen) Response|PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.|from baseline up to 104 weeks (study cut-off)|Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA >20ng/mL.|||Percentage of participants||95% Confidence Interval|Number
2815286|NCT00417079|Secondary|Time to Prostatic Specific Antigen (PSA) Progression|"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.~In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later."|at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
2815287|NCT00417079|Secondary|Time to Tumor Progression|Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
2815288|NCT00417079|Secondary|Overall Tumor Response|"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):~Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.~Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.~Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response."|From the date of randomization up to 104 weeks (study cut-off)|Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).|||percentage of participants||95% Confidence Interval|Number
2815289|NCT00417079|Secondary|Time to Progression Free Survival (PFS)|Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
2815290|NCT00417079|Primary|Overall Survival|"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.~In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first."|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).|||Months||95% Confidence Interval|Median
2815291|NCT00417027|Secondary|Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.|Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.|24 hours following labor analgesia|per protocal|||Scores on a scale (0 toi 100)||Inter-Quartile Range|Median
2815294|NCT00417027|Secondary|Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered|Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.|Duration of labor analgesia|per protocal|||participants||Inter-Quartile Range|Mean
2815295|NCT00417027|Secondary|Patient Controlled Bolus Attempts|The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.|Duration of labor analgesia|per protocal|||number of bolus attempts||Inter-Quartile Range|Mean
2815296|NCT00417027|Secondary|Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve|The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.|Duration of labor analgesia|per protocal|||0 to 100 mm per hour||Inter-Quartile Range|Median
2815297|NCT00417027|Primary|Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.|Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.|From initiation of labor analgesia until delivery less than 24 hours|per protocal|||mg bupivacaine per hour||Inter-Quartile Range|Median
2815298|NCT00416949|Primary|Tumor Absorbed Dose|Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.|up to 4 years|Was only able to analyze tumor data from 3 patients based on number of tumors that could be reliably imaged for analysis.|||Gy|number of tumors|Standard Deviation|Mean
2815299|NCT00416884|Primary|Number of Participants With Treatment-related Mortality|Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding|lifetime followup, up to 100 years.||||Participants|||Number
2815300|NCT00416793|Secondary|Overall Response Rate|Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.|from assignment of treatment until the date of first documented progression, assessed up to 17 months||||Participants|||Count of Participants
2815301|NCT00416793|Primary|Overall Survival Rate at 6 Months|Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.|up to 6 months|Analysis was per protocol; Limited analysis due to study early termination.|||Proportion of participants|||Number
2815302|NCT00416715|Secondary|Letrozole Serum Levels Before and After Vitamin D Repletion|Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.|Baseline and 1 month post vitamin D repletion|Only considering those patients who were baseline vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.|||micro-grams/mL||Inter-Quartile Range|Median
2815303|NCT00416715|Primary|Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness|Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.|Baseline and 1 month post vitamin D repletion||||Participants|||Count of Participants
2815304|NCT00416624|Secondary|Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
2815305|NCT00416624|Secondary|Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
2815306|NCT00416624|Secondary|Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
2815307|NCT00416624|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.|||units on a scale||Standard Deviation|Mean
2815308|NCT00416624|Secondary|The Percentage of Participants Reported Grade 3 or 4 Adverse Events|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|16 weeks|All patients that were evaluable per protocol and reported at least one value after baseline.|||percentage of participants|||Number
2815309|NCT00416624|Secondary|The Percentage of Participants With Dose Omitted Due to Hematologic Reason|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 Weeks|All patients that were evaluable per protocol.|||percentage of Participants|||Number
2815310|NCT00416624|Secondary|The Total RBC Transfusion Needed|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.|||g/dL||Standard Deviation|Mean
2815311|NCT00416624|Secondary|The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.|||percentage of participants|||Number
2815312|NCT00416624|Secondary|Mean Hemoglobin Change From Week 1 to Week 16|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.|Week 1 and Week 16|All patients that were evaluable per protocol and had hemoglobin data.|||g/dL||Standard Deviation|Mean
2815313|NCT00416624|Secondary|Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had hemoglobin levels data.|||days||95% Confidence Interval|Median
2815314|NCT00416624|Secondary|Weekly Change in Hemoglobin Levels|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule|Baseline and Week 4, 7, 10, 13, 16|All patients that were evaluable per protocol and had hemoglobin data at baseline, week 4, 7, 10, 13 or 16.|||g/dL||Standard Deviation|Mean
2815315|NCT00416624|Primary|The Percentage of Participants Who Exhibit a Hematopoietic Response|A hematopoietic response was defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period|20 weeks|All patients that were evaluable per protocol.|||Percentage of participants|||Number
2815316|NCT00416598|Other Pre-specified|Relationship Between Busulfan Pharmacokinetics (Area Under the Curve) and Relapsed Disease|Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.|At baseline, after 2, 4, and 6 hours after the start of busulfan infusion|||||||
2815317|NCT00416598|Primary|Disease-free Survival (DFS) Rate at 1 Year|"For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL)."|At 1 year||||percentage of participants|||Number
2815318|NCT00416598|Primary|Number of Participants Who Completed Maintenance Decitabine.|To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.|Up to 5 years||||participants|||Number
2815319|NCT00416572|Primary|Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).|Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.|||units on a scale||Standard Deviation|Mean
2815320|NCT00416572|Primary|Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).|Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.|||units on a scale||Standard Deviation|Mean
2815321|NCT00416572|Primary|Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.|Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.|||units on a scale||Standard Deviation|Mean
2815322|NCT00416520|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.|week12 minus week0|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.|||mg / dL||Standard Deviation|Mean
2815386|NCT00415597|Secondary|Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|52 weeks|Patients with data at Week 52|||Percent change||Standard Deviation|Mean
2815323|NCT00416520|Primary|Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.|week16 minus week12|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.|||mg / dL||Standard Deviation|Mean
2815324|NCT00416494|Other Pre-specified|Effect on Wound Angiogenesis||After study completion|||||||
2815325|NCT00416494|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion|||||||
2815326|NCT00416494|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.||||participants with adverse event|||Number
2815327|NCT00416494|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.||||months||95% Confidence Interval|Median
2815328|NCT00416494|Secondary|Disease Free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.||||months||95% Confidence Interval|Median
2815329|NCT00416494|Secondary|Time to Progression|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression, assesed up to 60 months.||||months||95% Confidence Interval|Median
2815330|NCT00416494|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who had restaging scans were included in the analysis.|||percentage of participants with response||95% Confidence Interval|Number
2815331|NCT00416455|Secondary|Cause of Interruption in Radiation Therapy in Cervical Cancer Patients|Number of cervical cancer patients with reasons of interruption in radiation therapy|Within 6 weeks after surgery|Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced an interruption in radiation therapy|||Participants|||Count of Participants
2815332|NCT00416455|Secondary|Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients|Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy|Within 4 weeks from PET/CT|All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy and the reason they experienced a delay in the initiation of chemo-radiation|||Participants|||Count of Participants
2815333|NCT00416455|Secondary|Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy|Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.|During surgery and up to 30 days after surgery.|All loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy|||Participants|||Count of Participants
2815334|NCT00416455|Secondary|Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node||Before surgery (FDG-PET/CT) and after surgery (pathology)|Particpants with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants|||Number
2815335|NCT00416455|Secondary|Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes||Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants|||Number
2815336|NCT00416455|Secondary|Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
2815374|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
2815337|NCT00416455|Secondary|Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815338|NCT00416455|Secondary|Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815339|NCT00416455|Secondary|Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815340|NCT00416455|Secondary|Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815341|NCT00416455|Secondary|Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815342|NCT00416455|Secondary|The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Cervical cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
2815343|NCT00416455|Secondary|The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||Percentage of participants||95% Confidence Interval|Mean
2815344|NCT00416455|Secondary|The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis|The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815345|NCT00416455|Secondary|The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.|Before surgery (DCT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
2815375|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
2815346|NCT00416455|Primary|The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen|The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.|Before surgery (FDG-PET/CT) and after surgery (pathology)|Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.|||percentage of participants||95% Confidence Interval|Mean
2815347|NCT00416455|Primary|The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen|The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.|Before surgery (FDG-PET-CT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients|||percentage of participants||95% Confidence Interval|Mean
2815348|NCT00416312|Primary|Tumor Absorbed Dose|tumor absorbed dose (Gy)|up to 4 years||||Gy|tumor|Standard Deviation|Mean
2815349|NCT00416195|Secondary|Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF||Baseline, Day 85 through Day 112|ITT population (LOCF)|||Percent change||Full Range|Median
2815350|NCT00416195|Primary|Percentage of Responders During the Maintenance Phase|A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.|Day 85 through Day 112|ITT population- all subjects in the Safety Population (all randomized subjects who took at least 1 dose of study drug) who had at least 2 weeks of baseline seizure frequency data and at least 1 week of seizure frequency data after baseline (LOCF - last observation carried forward)|||Percentage of Participants|||Number
2815351|NCT00416182|Secondary|Pulmonary Function|prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome.|baseline and 1 year||||percentage of predicted FEV1||Full Range|Mean
2815352|NCT00416182|Secondary|Chronic Sinusitis Survey Score|pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome.|baseline and 1 year||||units on a scale||95% Confidence Interval|Mean
2815353|NCT00416182|Primary|Improvement in Appearance of Nasal Passages/Sinuses|"periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome).~independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)"|baseline and 1 year||||units||95% Confidence Interval|Mean
2815354|NCT00416182|Primary|Computed Tomography Evidence of Less Sinus Disease|compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)|baseline and 1 year||||units on a scale||95% Confidence Interval|Mean
2815355|NCT00416078|Other Pre-specified|Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline|Frequency count of individuals placed in assisted living or nursing homes|baseline to end-of-follow-up (12 months from baseline)|Numbers vary; patients only at risk for out-of-home placement if alive and with data during follow-up periods|||participants|||Number
2815356|NCT00416078|Primary|Change in Caregiver Depression From Baseline|Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
2815357|NCT00416078|Primary|Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline|Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver's level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
2815358|NCT00416078|Primary|Change in Frequency of Patient Problematic Behavioral Patterns From Baseline|Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
2815359|NCT00416078|Primary|Change in Caregiver Burden From Baseline|Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)|||units on a scale||Standard Error|Least Squares Mean
2815360|NCT00416078|Secondary|Change in Caregiver Report of Patient Medication Adherence From Baseline|Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.|baseline to end-of-treatment (6 months)|measure was added to study while in process|||units on a 1-5 scale||Standard Error|Least Squares Mean
2815361|NCT00415909|Primary|Response Rate (Major and Complete Cytogenetic Response)|Rate is defined as number of participants with response of Major and Complete cytogenetic response out of total study participants. Response evaluated at one and 3 months from start of therapy, then every 3 months in patients with response, for one year, then every 6-12 months. Responses classified according to suppression of Philadelphia (Ph) chromosome by cytogenetic analysis: a) Complete cytogenetic response - Not Ph positive; b) Major cytogenetic response - Ph positive 1-34% of pretreatment value; c) Minor cytogenetic response - Ph positive 35-65% of pretreatment value; d) Minimal cytogenetic response - Ph positive 65-99% of pretreatment value; e) No cytogenetic response - Ph positive 100% of pretreatment value.|Evaluated at baseline (pretreatment) up to 12 months|All three patients received the planned 9 administrations of TALL-104.|||percentage of participants|||Number
2815362|NCT00415870|Secondary|Compliance With Food Monitoring Activities||4 months|We did not collect these data from the phone nor reported them in our main outcome paper. To the best of our recollection we shifted our emphasis from recording types of food and amounts of food to the behaviors of eating that were reflected in the Eating Behavior Inventory (O'Neill et al, 1979; citation #20 in the main outcome paper).||||||
2815363|NCT00415870|Secondary|Program Satisfaction|Participants reported a 2 if they liked the program, 1 if they felt neutral about the program, and 0 if they did not like program. Higher scores reflect greater satisfaction.|4 months|Participants in the control condition did not receive the program satisfaction survey. For those in the PACE-intervention arm, it was not mandatory to complete the program satisfaction survey and thus the number of participants who completed it are reflected in the data submitted.|||score on a scale||Standard Deviation|Mean
2815364|NCT00415870|Primary|Mean Weight (kg)||4 months||||kg||Standard Deviation|Mean
2815365|NCT00415857|Secondary|Number of Participants With Immunologic Response|Immunologic Response (immune response) is defined as an increase of ≥ 0.5 PR1-HLA-A2 [human leukocyte antigen-A2 (HLA-A2)] tetramer cells / μl at the time of either the 3rd or 4th vaccination compared to the pre study absolute PR1-HLA-A2 tetramer cells / μl. Participants receive a total of 4 vaccinations over a period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). Participants assessed after 3rd and 4th vaccination for immunologic response.|Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18).||||participants|||Number
2815366|NCT00415857|Primary|Molecular Response Rate|Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.|Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.||||percentage of participants|||Number
2815367|NCT00415636|Secondary|Percentage of Participants With Best Overall Response|Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm * 100.|baseline up to 24 months|A modified intent-to-treat population (mITT) was used to summarize the data for tumor response. The mITT population consisted of all participants who received any dose of study drug and had at least 1 nonmissing postbaseline tumor response assessment.|||Percentage of participants|||Number
2815368|NCT00415636|Secondary|Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])|AUC[0-∞] was calculated from the plasma concentration data of LY2603618 versus time profiles.|Day 1 and Day 9 of Cycle 1|Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.|||nanograms*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2815369|NCT00415636|Secondary|Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618|Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.|Day 1 and Day 9 of Cycle 1|Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.|||nanograms per millimeter (ng/mL)||Standard Deviation|Mean
2815370|NCT00415636|Primary|Number of Participants With Adverse Events (AEs)|Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.|baseline up to 24 months|The safety population was comprised of all participants who received any amount of LY2603618.|||Participants|||Count of Participants
2815371|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg||Baseline, Week 4, and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
2815372|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg||Baseline, Week 4 and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
2815373|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
2815376|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward|||participants|||Number
2815377|NCT00415623|Secondary|Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)|"Arithmetic mean of Week 6 & Week 8 by patient for Change from baseline in DBP at Week 6 and Change from baseline in DBP at Week 8"|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
2815378|NCT00415623|Secondary|Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)|"Arithmetic mean of Week 6 & Week 8 by patient for Change from baseline in SBP at Week 6 and Change from baseline in SBP at Week 8"|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
2815379|NCT00415623|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8|Mean change in the trough DBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
2815380|NCT00415623|Primary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 8|Mean change in the trough SBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward|||mmHg||95% Confidence Interval|Least Squares Mean
2815381|NCT00415610|Other Pre-specified|Particpants Who Achieve Reduction of Blood Pressure and Maintain Treatment Goals (the Specified Systolic Blood Pressure Range for the 18-24 Hour Period) Without Neurological Deterioration or Side Effects Resulting in Death.|"The tolerability of the study treatment was further ascertained by examination of in-hospital, 1-month, or 3-month mortality in each treatment group.~This pilot study was not powered (did not plan to enroll an adequate number of patients) to draw meaningful conclusions about individual adverse event categories, outcome measures, or to make comparisons between the treatment arms beyond the overall feasibility and tolerability of rapidly and significantly lowering SBP following intracerebral hemorrhage.~The timing and magnitude of SBP reduction was also compared to the timing of individual safety events to further evaluate possible relationships between the study treatment, adverse events, and any recognizable safety concerns. This information is available in publication but is not able to be displayed on this website due to formatting restrictions."|From enrollment through 3 months|Serious adverse events were monitored for all patients throughout the 3-month study period; when mortality resulted death was categorized as having occurred prior to or following hospital discharge. The 3-month mortality count includes deaths that occurred earlier. Survival was confirmed at hospital discharge, 1 month, and 3 months.|||Participants|||Count of Participants
2815382|NCT00415610|Secondary|Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals|The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects|3 months|All subjects were analyzed by treatment arm for the presence of SAEs, neurological deterioration, symptomatic or asymptomatic hematoma expansion, and mortality in-hospital or within 3 months. Pre-specified safety stopping rules were used. The nature and relatedness of events was examined and overseen by an external Data safety and Monitoring Board.|||participants|||Number
2815383|NCT00415610|Primary|Total Number of Serious Adverse Events Within the Initial 72 Hours From Treatment Per Subject|Serious adverse events were ascertained by site investigators using FDA-defined guidelines, defined as any untoward clinical events having been fatal, life-threatening, resulting in new or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage. Subjects were followed closely from randomization through 90 days. The initial 72-hour period was chosen as the most meaningful time period for which to examine SAEs likely to be related to the acute safety of the study treatment.|from treatment initiation through 72 hours|All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. When safety stopping rules could not have triggered after 18 initial subjects recruitment was adjusted to weight the subsequent tiers.|||Participants|||Count of Participants
2815384|NCT00415610|Primary|"Number of Participants With Neurological Deteriorations (Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score) During the 24 Hour Treatment,"|Neurological status was monitored quantitatively and independently of other adverse events using two scales. The Glasgow Coma Scale (GCS) score measures level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movements, visual fields, facial palsy, movement in each limb, sensation, language and speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42; 0 indicates normal function and higher scores indicate greater deficit severity.|within the first 72 hours of treatment initiation|All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. When safety stopping rules could not have triggered after 18 initial subjects recruitment was adjusted to weight the subsequent tiers.|||participants|||Number
2815385|NCT00415610|Primary|Particpants Who Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier.|Feasibility of treatment was assessed by whether SBP reduction and maintenance within the respective target range was achieved (treatment success) or not (treatment failure), and secondarily by whether a significant difference between treatment arms was achieved. Treatment failure was defined based on the observed hourly hourly minimum SBP remaining greater than the upper limit of the target range for 2 consecutive hours after initiation of nicardipine infusion. Spontaneous decline of SBP below the lower limit of the specific tier was not considered treatment failure as all such declines were asymptomatic.The lower number in the more intensive treatment groups reflects in part the greater challenge of rapidly lowering systolic blood pressure to a more intensive (lower) range, as a higher number of treatment failures as pre-defined by meeting the SBP range goal within 3 hours of symptom onset in this group predictably occurred.|Within 3 hours of symptom onset and sustained through 18-24 hours.|All subjects were evaluated for achievement of the treatment goals.|||participants|||Number
2815387|NCT00415597|Secondary|Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|12 weeks|Patients with data at Week 12|||Percent change||Standard Deviation|Mean
2815388|NCT00415597|Primary|Subjects With Treatment Emergent Adverse Events|Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).|up to 12 months|Patients treated with study drug|||participants|||Number
2815389|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Activity|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of activity. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.~Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set|||Units on a scale||Standard Error|Least Squares Mean
2815390|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Bother|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of bother. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set|||Units on a scale||Standard Error|Least Squares Mean
2815391|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Fatigue|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of fatigue. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set.|||Units on a scale||Standard Error|Least Squares Mean
2815392|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Symptoms|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of symptoms. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.~Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set|||Units on a scale||Standard Error|Least Squares Mean
2815393|NCT00415532|Secondary|Percentage of Participants With Platelet Response|Platelet response was defined as platelet counts > 50 x 10^9/L, measured at each study visit (excluding those within 8 weeks of prior rescue medication use) up to the time of splenectomy or the end of initial treatment period, whichever occurred first.|Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|"Full analysis set. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
2815394|NCT00415532|Secondary|Time to Splenectomy|Time to splenectomy in days calculated from date of randomization to date of splenectomy, or censored at date of end of treatment visit if no splenectomy was done during treatment period.|52 weeks|Full analysis set|||days||95% Confidence Interval|Median
2815395|NCT00415532|Primary|Number of Participants With Treatment Failure During 52-Week Treatment Period|Treatment failure was defined by platelet counts ≤ 20 x 10^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.|52 weeks|Full analysis set. Participants who discontinued study during treatment period prior to experiencing treatment failure were considered as having had treatment failure.|||Participants|||Number
2815396|NCT00415532|Primary|Number of Participants With Splenectomy During 52-Week Treatment Period|Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.|52 weeks|The Full Analysis set includes all randomized patients.|||Participants|||Number
2815397|NCT00415519|Primary|Percentage of Participants With Abnormal Changes in Sensory Examinations|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks|"A note:~Each three patients of both groups did not have data to Staggering due to data missing. Therefore, concerning staggering, the number of participants analysed are 10 in the MCI-186 group and 9 in the placebo of MCI-186 group."|||percentage of participants|||Number
2815398|NCT00415519|Primary|The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks||||percentage of participants|||Number
2815399|NCT00415519|Primary|Percentage of Participants With Adverse Drug Reactions|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks||||percentage of participants|||Number
2815400|NCT00415519|Primary|Percentage of Participants With Adverse Events|No primary endpoint was used, because various exploratory analyses were performed.|24 weeks||||percentage of participants|||Number
2815401|NCT00415519|Primary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks|No primary endpoint was used, because various exploratory analyses were performed.|baseline and 24 weeks|"1 patient with missing value at baseline was excluded from the FAS in the MCI-186 group."|||percentage of FVC||Standard Error|Least Squares Mean
2815402|NCT00415519|Primary|Death or a Specified State of Disease Progression|"No primary endpoint was used, because various exploratory analyses were performed.~Any of death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding was defined as an event."|24 weeks||||events|||Number
2815403|NCT00415519|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|"No primary endpoint was used, because various exploratory analyses were performed.~0=worst; 48=best"|baseline and 24 weeks||||units on a scale||Standard Error|Least Squares Mean
2815404|NCT00415506|Primary|Improved Control of Inflammation|"For patients with scleritis, disease activity as measured by a modified grading system first described by McCluskey et al. (McCluskey and Wakefield 1987; McCluskey and Wakefield 1991). Improvement in scleritis activity will be defined as a reduction in this grading score of 2 or more, or an overall score of 4 or less by 24 weeks.~For patients with orbital inflammation, disease activity as measured by a modified grading system first devised by Werner (Werner 1977). Improvement in orbital inflammation will be defined as a reduction in this grading score of 2 or more, or an overall score of 3 or less."|24 weeks||||participants|||Number
2815405|NCT00415506|Primary|Reduction of Medications|Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.|24 Weeks|Only patients currently on systemic corticosteroids were analyzed for this outcome point.|||participants|||Number
2815406|NCT00415493|Primary|Net Proportional Change in Nasal Airway Resistance|Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.|One hour||||proportional change (unit-less)||Standard Error|Mean
2815407|NCT00415194|Secondary|Correlation Between Biomarkers and Treatment Effect|"Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.~0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data."|Baseline|Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.|||correlation coefficient|||Number
2815408|NCT00415194|Secondary|Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score|FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.|Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months|Intention to treat (ITT) population with at least Baseline data.|||Months||95% Confidence Interval|Median
2815409|NCT00415194|Secondary|Duration of Response (DoR)|DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.|time of response to progressive disease up to 24 months|ITT population with a confirmed best response of complete response (CR) or partial response (PR).|||Months||95% Confidence Interval|Median
2815410|NCT00415194|Secondary|Percent of Participants With a Tumor Response (Response Rate)|Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100|Baseline to progressive disease or discontinuation of study treatment up to 11 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||Percentage of participants|||Number
2815411|NCT00415194|Secondary|Progression-free Survival (PFS)|Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.|baseline to measured progressive disease up to 33 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||months||95% Confidence Interval|Median
2815412|NCT00415194|Primary|Overall Survival (OS)|OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date.|Baseline to date of death from any cause up to 36 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||Months||95% Confidence Interval|Median
2815413|NCT00415168|Secondary|Number of Participants Who Died During the Study||During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||participants|||Number
2815414|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||participants|||Number
2815415|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||participants|||Number
2815416|NCT00415168|Secondary|Overall Survival|Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up.|Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||months||95% Confidence Interval|Median
2815417|NCT00415168|Secondary|Progression Free Survival (PFS)|Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005).|Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||months||95% Confidence Interval|Median
2815418|NCT00415168|Secondary|Duration of Response|Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression.|Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.|||months||95% Confidence Interval|Median
2815419|NCT00415168|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.|Baseline to time of response up to six or eight 21-day cycles of treatment|All patients enrolled in the study with a histologically confirmed diagnosis of adenocarcinoma of the gastric, disease status of measurable disease with presence of at least 1 measurable lesion, with no concurrent administration of any other tumor therapy or known or suspected brain metastasis who received at least 1 dose of study therapy.|||percentage of responders||95% Confidence Interval|Number
2815420|NCT00415051|Secondary|Genetic Stability - Characterize Viral Isolate (Plasma) Frequency|In vitro systems will be used to evaluate genetic stability (examining viremia levels in plasma by direct plaque assay techniques or by blind passage of plasma on Vero cells and sequencing the ribonucleic acid (RNA) and comparing these findings with those from the vaccine virus inoculum).|Days 0-14|1 subject was excluded for receiving another vaccination within 30 days of intended MP-12 vaccination.|||Participants|||Count of Participants
2815421|NCT00415051|Secondary|Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine|Immune response will be assessed by measuring days to peak response for PRNT50 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12||||Days||Standard Deviation|Mean
2815422|NCT00415051|Secondary|Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus|Immune response will be assessed by measuring days to peak response for PRNT80 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12||||Days||Standard Deviation|Mean
2815423|NCT00415051|Primary|Safety as Measured by the Number of Adverse Events|AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.|up to 1 year||||AEs|||Number
2815424|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visit.|||percentage change in osteocalcin||Inter-Quartile Range|Median
2815425|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in total hip BMD||Standard Error|Least Squares Mean
2815426|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
2815427|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visits.|||percentage change in osteocalcin||Inter-Quartile Range|Median
2815479|NCT00414596|Secondary|Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.|The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.|Six weeks||||participants|||Number
2815428|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in total hip BMD||Standard Error|Least Squares Mean
2815429|NCT00414973|Primary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward.|||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
2815430|NCT00414908|Other Pre-specified|"Change of Stool Frequency Between Original Baseline and End of Open-label Period (OL)"|Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency).|27 weeks|This analysis is done on the Open-Label period of 6 months.|||Number||Standard Deviation|Mean
2815431|NCT00414908|Secondary|Flatulence at the End of Double-blind Period|4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Participants|||Number
2815432|NCT00414908|Secondary|Stool Consistency at the End of the Double-blind Period|4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Participants|||Number
2815433|NCT00414908|Secondary|Abdominal Pain at the End of the Double-blind Period.|4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Participants|||Number
2815434|NCT00414908|Secondary|Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Number||Standard Error|Least Squares Mean
2815435|NCT00414908|Secondary|Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Grammes||Standard Error|Least Squares Mean
2815436|NCT00414908|Secondary|Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Grammes||Standard Error|Least Squares Mean
2815437|NCT00414908|Secondary|Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.|The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Percentage||Standard Deviation|Mean
2815438|NCT00414908|Primary|Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.|"The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.~Change is calculated as (DB CFA-Baseline CFA)."|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.|||Percentage||Standard Deviation|Mean
2815439|NCT00414817|Secondary|Rate of Acute Health Care Visits for Asthma|annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.|Measured over 19 months of follow-up|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.|||number of events per year||Standard Deviation|Mean
2815440|NCT00414817|Secondary|Juniper Asthma Quality of Life Questionnaire (Global Score)|Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.|Measured at 19 months|We assessed this outcome on a random sample of study participants that over-sampled intervention participants. All were existing users of ICS at the outset of the study who qualified for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.|||unitless scale ranging from 1-7||Standard Deviation|Mean
2815514|NCT00414271|Secondary|Overall Survival|Median number of months participants alive at the time of observation. Calculated using Kaplan-Meier method.|up to 8 years|1 participant was lost to follow-up after progression from neoadjuvant chemotherapy.|||months||Full Range|Median
2815441|NCT00414817|Primary|Modified Medication Possession Ratio|We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.|Measured over 19 months|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.|||fraction of days with medication||Standard Deviation|Mean
2815442|NCT00414726|Primary|Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|4 hours after starting treatment||||0-4 hour change in NIHSS score||95% Confidence Interval|Mean
2815443|NCT00414726|Primary|Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|24 hours||||0-24 hour change in NIHSS score||95% Confidence Interval|Mean
2815444|NCT00414700|Post-Hoc|Number of Treatment Failures at 60 Months Post-surgery|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 60 months.~The index lesion is the lesion that was initially treated in the study."|60 months||||participants|||Number
2815445|NCT00414700|Post-Hoc|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 60 Months|Patient-administered instrument to assess the patients opinion about their knee and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.|60 months|FAS population with imputation for treatment failures by LOCF|||units on a scale||Standard Error|Mean
2815446|NCT00414700|Secondary|Safety: Adverse Events|Side effects are recorded as the number of patients with adverse events. These events are coded according to the Medical Dictionary for Regulatory Affairs (MedDRA terms).|continuous up to 60 months||||participants|||Number
2815447|NCT00414700|Secondary|Number of Treatment Failures at 36 Months|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 36 months.~The index lesion is the lesion that was initially treated in the study."|Continuous||||Participants|||Number
2815448|NCT00414700|Secondary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 36 Months|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains: Activities of Daily Living, Quality of Life, Symptoms and Stiffness Pain; Sports not included) at 36 months (change from baseline). Best = 100; worst = 0.|Change from baseline in Overall KOOS at 36 months post-surgery||||Units on a scale||Standard Error|Mean
2815449|NCT00414700|Primary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average)|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.|Average change from baseline in Overall KOOS at 12-18 months post-surgery|FAS (with LOCF for treatment failures)|||points on a scale (0-100)||Standard Error|Least Squares Mean
2815450|NCT00414700|Primary|Overall Histology Assessment on First Subscale of ICRS II Score|Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)|12 months post-surgery|FAS|||Points on a scale||Standard Error|Least Squares Mean
2815451|NCT00414700|Primary|Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining|Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.|12 months post-surgery|Full Analysis Set (FAS)|||Ratio||Standard Error|Least Squares Mean
2815452|NCT00414661|Other Pre-specified|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, 12, 18, 24|Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2815453|NCT00414661|Primary|Incidence of Important Infections|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.|||Infections per 100 person-years||95% Confidence Interval|Number
2815660|NCT00413374|Primary|Major Bleeding Complication|Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.|30 Days||||participants|||Number
2815454|NCT00414661|Primary|Incidence of Lymphoma|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.|||Lymphoma per 100 person-years||95% Confidence Interval|Number
2815455|NCT00414661|Primary|Incidence of Lymphoproliferative Disorders (LPD)|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.|||LPD per 100 person-years||95% Confidence Interval|Number
2815456|NCT00414635|Secondary|Deviation From FOTO Schedule by One Extra Dose|Percentage of FOTO participants who took a dose during weekend planned interuption period|4, 12, 24 weeks||||Percentage of Participants|||Number
2815457|NCT00414635|Secondary|Self-reported Adherence Summary in Both Arms|Percentage of participants who missed one or more doses in weekly regimen.|4, 12 and 24 weeks||||percentage of participants|||Number
2815458|NCT00414635|Secondary|Trough Blood Levels of Efavirenz in Both Arms|blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)|12 or 60 hours||||Percentage of Participants|||Number
2815459|NCT00414635|Secondary|"Absolute Number of Virological Blip Events Occurring Over 24 Weeks"|"Total number of blip events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml"|Baseline to week 24||||blip events|||Number
2815460|NCT00414635|Secondary|Quality of Life|"Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as I Perfer taking HIV medications 7 days/week and 10 was defined as I perfer 5 days on and 2 days off. We present results of a single question on quality of life experienced while on their study ART regimen."|4 weeks|The questionnaire was only applicable to FOTO arm|||Units on a Scale||Inter-Quartile Range|Median
2815461|NCT00414635|Secondary|Mean CD4+ T-cell Count Increases From Baseline to Week 24.||Baseline to Week 24||||cells/ml||95% Confidence Interval|Mean
2815462|NCT00414635|Primary|Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)|Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)|24 weeks|Per protocol|||Percentage of Participants|||Number
2815463|NCT00414609|Secondary|Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter|"Fasting blood samples were collected throughout the study and were analyzed at a central laboratory. Percentage of participants with the following clinically significant laboratory values are reported:~Potassium <3.5 mmol/L; Low value (Normal reference range: 3.5- 5.3)~Potassium >5.5 mmol/L and Potassium >6.0 mmol/L; High values (Normal reference range: 3.5-5.3)~Creatinine >176.8 μmol/L; High value (Normal reference range= Male: 62- 106 and Female 44- 80)~Blood Urea Nitrogen (BUN) >14.28; High value (Normal reference range: 2.1- 8.9)"|24 Months|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."|||Percentage of participants|||Number
2815464|NCT00414609|Secondary|Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change|Orthostatic blood pressure change is defined as a decrease of at least 20 mmHg in systolic blood pressure or a decrease of at least 10 mmHg in diastolic blood pressure when a patient moves from a sitting position to a standing position. A patient could show orthostatic blood pressure change at more than one visit. End of study is Month 24 or early discontinuation.|Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."|||Percentage of Participants|||Number
2815465|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12|Change from baseline to Month 12 in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.|||percent of blood pumped from LV chamber||Standard Deviation|Mean
2815466|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12|Change from baseline to Month 12 in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. LVEDV is a measurement of the volume of blood in the heart's left ventricular chamber at the beginning of the chamber's filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal.|Baseline (extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.|||Milliliter (mL)||Standard Deviation|Mean
2815467|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12|Change from baseline to Month 12 in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the heart's contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.|||Milliliter (mL)||Standard Deviation|Mean
2815468|NCT00414609|Primary|Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Extension study (24 weeks)|Extension Population (considered as Safety population) consisting of all enrolled patients who received at least one dose of study medication in the extension study.|||Percentage of participants|||Number
2815469|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography|Change from baseline to end of study in Wall Motion Score (WMS) as measured by echocardiography. WMS was obtained by examining multiple segments of the left ventricle and assigning each segment a score based on myocardial thickening: 1 for normal, 2 for hypokinetic; 3 for akinetic; and 4 for dyskinetic. The WMS was obtained as the average score for the segments visualized and was calculated by the echocardiography lab. Possible values range from 1 to 5. Higher scores are considered worse. Baseline WMS was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||Scores on a scale||Standard Error|Least Squares Mean
2815470|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography|Change from baseline to end of study in infarction segment length (ISL) (%) as measured by echocardiography. This is the length of the myocardial infarction segment as a percentage of the total cavity perimeter length as calculated by the echocardiography lab. Baseline ISL was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||percent of total cavity perimeter length||Standard Error|Least Squares Mean
2815471|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|Change from baseline to end of study in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal. Baseline LVEF was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment )|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||percent of blood pumped from LV chamber||Standard Error|Least Squares Mean
2815472|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)|Change from baseline to end of study in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the beginning of the chamber's filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal. Baseline LVEDV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.|||mL||Standard Error|Least Squares Mean
2815473|NCT00414609|Secondary|Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes|Composite outcome 1 included: Cardiovascular (CV) Death, hospitalization for heart failure (HF), or absolute reduction in Left Ventricular Ejection Fraction (LVEF) greater than 6%. Composite outcome 2 included: CV Death, hospitalization for HF, recurrent Myocardial Infarction, Stroke, or Resuscitated Sudden Death. LVEF was measured at baseline and final visit. All other events were adjudicated by a blinded external committee. Each composite endpoint analysis was based on (a) the percent of patients with that endpoint and (b) days in study to 1st event (or last exposure if no event occurred).|LVEF was measured at baseline and at final visit (after 26 to 36 weeks of treatment). Other endpoint components were assessed from randomization until the end of the study (week 36).|Full Analysis Set (FAS) – All randomized patients who either (a) received study drug or (b) did not receive study drug but were not disqualified from randomization.|||Percentage of participants|||Number
2815474|NCT00414609|Primary|Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.|Change from baseline to end of study in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the heart's contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal. Baseline LVESV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set (patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment)|||mL||Standard Error|Least Squares Mean
2815475|NCT00414596|Secondary|Number of Patients Who Withdraw From Study.|Total number of patients who withdrew during the 6 weeks of treatment.|6 weeks||||participants|||Number
2815476|NCT00414596|Secondary|Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.|Total number of adverse events reported following 6 weeks of DRX9000 treatment.|Six weeks|All subjects enrolled were included in the analysis. No adverse events related to study device were reported.|||Number of Adverse Events|||Number
2815477|NCT00414596|Secondary|Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.|Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).|Six weeks||||units on a scale||Inter-Quartile Range|Mean
2815478|NCT00414596|Secondary|Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)|Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.|Six weeks||||Change in units of scale||Inter-Quartile Range|Median
2815480|NCT00414596|Primary|Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)|The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.|Six weeks||||units on a scale||Inter-Quartile Range|Median
2815481|NCT00414544|Secondary|Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months||3, 9 and 12 months|||||||
2815482|NCT00414544|Primary|Adverse Event Reporting||6 months|||||||
2815483|NCT00414544|Primary|Change in Wrinkle Severity Rating Scale|To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.|baseline and 6 months|Analysis was intention to treat (ITT) and each subject received both CosmetaLife and Control (Restylane) injections into contralateral nasolabial folds, respectively. WSRS units (change from baseline analyzed)|||units on scale||Standard Deviation|Mean
2815484|NCT00414518|Primary|Viral Set Point|set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus|Throughout study||||Log 10 copies virus/ml||Standard Deviation|Mean
2815485|NCT00414518|Primary|Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome||At Week 24||||participants|||Number
2815486|NCT00414518|Primary|Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms||At Week 24||||Log 10 copies of virus/ml||Standard Deviation|Mean
2815487|NCT00414466|Primary|Number of Participants With Treatment-emergent Adverse Events|Evaluation of adverse event profiles between placebo and active treatment groups.|Randomization to Post-randomization Day 29 (includes dose reduction)|All randomized subjects were included as per protocol.|||Participants|||Number
2815488|NCT00414466|Secondary|Responder Analysis Between Active Treatment and Placebo Groups.|Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.|Baseline to Post-randomization Day 22|All 170 randomized subjects were included as per protocol. Subjects experiencing an intolerable adverse event, discontinuing due to an adverse event or lack of efficacy, or not providing data were considered non-responders.|||Participants|||Number
2815489|NCT00414466|Primary|Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.|Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.|Baseline and Post-randomization Day 22|Primary efficacy analysis was performed on the 167 randomized subjects that completed at least 4 days of the electronic pain diary during the last 7 days prior to the Day 22 or Early Termination Visit as per protocol. No imputation methods were used.|||Scores on a scale||Standard Deviation|Mean
2815490|NCT00414453|Secondary|Kurtzke Expanded Disability Status Scale|Subject completes questionaire on functional status|Occurs at Visit 1|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815491|NCT00414453|Secondary|Patient Global Impression of Change Scale|Subject completes patient global impression questionaire of change scale|Occurs Visit 3, 4, 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815492|NCT00414453|Secondary|Short-Form McGill Pain Questionnaire|Subject completes short form McGill Pain questionaire|Occurs Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815493|NCT00414453|Secondary|Short-form Health Survey 36 (SF-36)|Subject completes short form health survey 36 questionaire|Occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815494|NCT00414453|Secondary|Beck Depression Inventory|Subject completes Beck questionaire|occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815495|NCT00414453|Secondary|Daily Diary Sleep Interference Ratings|Subject identifies degree of sleep interference on a daily basis|daily|Data was not analyzed because we did not reach our enrollment goal and the study was terminated.. Data was not analyzed because we the data is locked and is not available.||||||
2815496|NCT00414453|Secondary|Brief Pain Inventory Interference Items|subject completes the brief pain questionaire|occurs Visit 1, 3,4,5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815497|NCT00414453|Secondary|Safety (i.e., Number of Serious Adverse Events)|Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales|rating and review of any adverse events occurs at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815498|NCT00414453|Secondary|Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)|subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries|rating of adverse events occur at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.||||||
2815499|NCT00414453|Primary|Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period|subject identifies daily pain rating during final week of each treatment period using a numeric rating scale|Daily|Data was not analyzed because we the data is locked and is not available.||||||
2815661|NCT00413335|Primary|Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)|It refers to the percent changes of hepatic fat content.|4 months||||percentage of change from baseline||Standard Deviation|Mean
2815500|NCT00414440|Secondary|Calculated GFR (mL/Min/1.73 m^2), Change From Baseline by Visit|Change in renal function was assessed by the Glomerular Filtration Rate (GFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 3, 6, 9, 12, 18 and 24|ITT set, observed cases|||mL/min/1.73m^2|Participants|Standard Deviation|Mean
2815501|NCT00414440|Secondary|Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), at baseline and then months 12 and 24|Baseline, Months 12 and 24|ITT, observed cases|||mmHG|Participants|Standard Deviation|Mean
2815502|NCT00414440|Secondary|Calculated GFR, Change From Baseline at Month 60 by Baseline cGFR|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 24, 36, 48 and 60|ITT|||mL/min/1.73 m^2||Standard Deviation|Mean
2815503|NCT00414440|Secondary|Course of Calculated GFR (mL/Min/1.73 m^2) From Month 24 to Month 60|Course of calculated GFR (mL/min/1.73 m^2) at Months 24, 36, 48 and 60|Months 24, 36, 48 and 60|ITT|||mL/min/1.73 m^2||Standard Deviation|Mean
2815504|NCT00414440|Primary|Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation)|Everolimus (RAD001) compared to placebo with respect to the change from baseline in total kidney volume at Month 24.|Baseline, Month 24|mITT set|||mL||95% Confidence Interval|Mean
2815505|NCT00414388|Secondary|PSA -Biochemical Response|PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.|1-10 months||||percentage of participants|||Number
2815506|NCT00414388|Secondary|Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).|Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.|3-10 months||||percentage of patients|||Number
2815507|NCT00414388|Primary|Percentage of Patients Needing a Dose Reduction.|The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%|participants were followed for an average of 25 months|15 patients required dose reductions.|||percentage of participants|||Number
2815508|NCT00414310|Secondary|Overall Survival Rate|Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 7 years|One enrolled participant on the Decitabine arm was not treated, therefore not evaluable for response.|||months||Full Range|Median
2815509|NCT00414310|Secondary|Response Duration|The date of Response to the date of loss of response or last follow-up.|Up to 60 months|One enrolled participant on the Decitabine arm was not treated, therefore not evaluable for response.|||Months||Full Range|Median
2815510|NCT00414310|Primary|Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML|Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with < 5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 10^9/ L, and a platelet count > 100 x 10^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets <100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 10^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to <5% also considered clinical benefit.|1 Year|One enrolled participant on the Decitabine arm was not treated, therefore not evaluable for response.|||Percentage of Participants|||Number
2815511|NCT00414271|Secondary|Correlation of CGH and Gene Expression Profile and Their Changes After Chemotherapy With the Same Clinical Outcomes|Initially, we also planned to study the thymidylate synthetase expression, methylation of RUNX-3 gene[24] and comprehensive genomic hybridization[25] before and after chemotherapy to look for biomarkers of response and prognostic indication. But due to the lack of pCR and the small number of patients enrolled, we stopped the correlative studies.|up to 5 years|Data was not collected to assess this outcome measure.||||||
2815512|NCT00414271|Secondary|Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE.|Number of participants who experience Grade 3/4 neutropenia, Grade 3 nausea or Grade 3 diarrhea.|up to 5 years||||Participants|||Count of Participants
2815513|NCT00414271|Secondary|Progression-free Survival as Measured by Number of Participants Without Disease Progression.||up to 5 years||||Participants|||Count of Participants
2815515|NCT00414271|Primary|Number of Participants With Pathological Response|Number of participants who completed neoadjuvant chemotherapy and underwent repeat CT and endoscopic ultrasound (EUS) with pathological complete response (pCR), partial response in the primary tumor, stable disease or progressive disease as defined by EUS criteria.|up to 5 years|Only 15 of the participants who completed neoadjuvant chemotherapy and underwent repeat CT and EUS had measurable tumors by both imaging methods.|||Participants|||Count of Participants
2815516|NCT00414206|Primary|Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.||Baseline to Week 48|A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.|||Percent of subjects|||Number
2815517|NCT00414167|Secondary|Percent BMI Loss|Percent loss in Body Mass Index|8 weeks (baseline and 8 weeks)|Baseline values imputed forward for missing data.|||Percent loss||Standard Deviation|Mean
2815518|NCT00414167|Primary|Frequency of Binge Eating Episodes||One week (at post treatment)|Baseline forward imputation for missing data.|||episodes/week||Standard Deviation|Mean
2815519|NCT00414076|Primary|Progression Free Survival (PFS)|Number of participants progressed or death from study entry.|Every 12 weeks|1 out of 4 participants in the Letrozole arm progressed on study. 2 participants progressed in standard of care|||Participants|||Count of Participants
2815520|NCT00414050|Secondary|Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®|Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.|7 months of age (1 month after 3 doses)|Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.|||mIU/mL||95% Confidence Interval|Geometric Mean
2815521|NCT00414050|Primary|The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®|The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.|7 months of age (1 month after 3 doses)|Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.|||Percentage of participants||95% Confidence Interval|Number
2815522|NCT00414011|Primary|Corneal Epithelial Healing Time|patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)|3 to 4 days after surgery||||days to complete epithelial healing|Participants|Full Range|Median
2815523|NCT00413972|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint After 8 Weeks of Treatment||Baseline, 8 weeks|The number of participants for analysis included those from the ITT data set. 392 subjects were randomized in the study, but 3 of the randomized subjects were not treated and were excluded from the ITT data set. Therefore, only 389 subjects were included in the ITT data set.|||percent change of LDL-C||Standard Error|Mean
2815524|NCT00413959|Secondary|Overall Survival|The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.|4 years||||percentage of participants|||Number
2815525|NCT00413959|Primary|Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.|Percentage of complete responders plus percentage of partial responders equals overall response rate.|4 years|1 pt withdrew before completing two cycles and was not evaluable for OS.|||percentage of patients|||Number
2815526|NCT00413920|Secondary|Number of Participants Requiring Steroids in Non-steroid Treatment Group||Months 3 and 6||||Number of participants|||Number
2815527|NCT00413920|Secondary|Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status|"The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.~Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.~Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5."|Month 3|Intent-to-treat population. N in the categories is the number of participants from the total population that fit into that category for each arm/group. For example: in the Delayed Graft Function category there were 25 participants in the Without steroid group and 24 participants in the With Steroid Group.|||Number of participants|||Number
2815528|NCT00413920|Secondary|Number of Participants With Subclinical Histological Rejections|The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.|Month 3|Intent-to-treat population on whom biopsies were performed at 3 months.|||Number of participants|||Number
2815529|NCT00413920|Secondary|Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months|A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|Month 3|Intent-to-treat population|||Number of participants|||Number
2815530|NCT00413920|Secondary|The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months|If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.|Month 6|Intent-to-treat population|||Number of participants|||Number
2815531|NCT00413920|Primary|Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation|Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|6 months post transplantation|Intent-to-treat population|||Number of participants|||Number
2815532|NCT00413894|Secondary|Percentage of Participants Requiring Erythrocyte Transfusions||Visits 1 to 10 (Months -2 to 8)|Safety Population (SAF): All participants who received at least one dose of study medication independent from whether they completed the study or not were included into the safety analysis.|||percentage of participants|||Number
2815533|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Screening Phase|Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.|Visits 1 to 2 (Months -2 to -1)|ITT Population|||percentage of participants|||Number
2815534|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Evaluation Phase|Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.|Visits 8 to 10 (Months 6 to 8)|ITT population|||percentage of participants|||Number
2815535|NCT00413894|Secondary|Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels|"Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.~Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted."|Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)|ITT Population;|||percentage of participants|||Number
2815536|NCT00413894|Secondary|Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category|||percentage of participants|||Number
2815537|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category|||percentage of participants|||Number
2815538|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population|||percentage of participants|||Number
2815539|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population: All participants having received at least one dose of study medication and having at least one Hb value measurement under C.E.R.A. were included.|||percentage of participants|||Number
2815540|NCT00413894|Primary|Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; n = number of participants in the specified category|||percentage of participants|||Number
2815541|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; number (n) equals (=) number of participants in the specified category|||percentage of participants|||Number
2815542|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|CP|||percentage of participants|||Number
2815543|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|Completer Population (CP) included only participants who completed the study until Visit 10 (Month 8).|||percentage of participants|||Number
2815544|NCT00413777|Secondary|Mean Change From Baseline in Abdominal Girth Measurement- Extension.|The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged).|Baseline to Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||cm||Standard Deviation|Mean
2815662|NCT00413335|Secondary|Mean Percent Change From Baseline in Adiponectin|This refers to the changes of adiponectin levels.|4 months||||percentage of change from baseline||Standard Deviation|Mean
2815545|NCT00413777|Secondary|Mean Change From Baseline in Abdominal Girth Measurement.|The participant had a measurement of their abdominal girth recorded. The measurement will be taken with a tape measure extending around the abdomen at the level of the iliac crests laterally and the umbilicus anteriorly. The examiner should also palpate for each kidney and liver edge, noting presence or enlargement. (By definition if the kidneys are palpable they are enlarged, the liver edge may be palpable but not enlarged).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||cm||Standard Deviation|Mean
2815546|NCT00413777|Secondary|Mean Change From Baseline in Patient-assessed Renal Pain Scale- Extension.|"Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months? If the latest assessment was less than 4 months prior, the question was substituted since your last visit for in the last 4 months. The same interrogator designated to this task was used throughout the study for each participant."|Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Units on a scale||Standard Deviation|Mean
2815547|NCT00413777|Secondary|Mean Change From Baseline in Patient-assessed Renal Pain Scale.|"Participants were asked the question to assess the relative level of pain attributed to their kidneys. This question was, On a scale of 0 to 10, with zero represented no pain at all and 10 represented the worst pain ever experienced, what was the worst kidney pain experienced in the last 4 months? If the latest assessment was less than 4 months prior, the question was substituted since your last visit for in the last 4 months. The same interrogator designated to this task was used throughout the study for each participant."|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Units on a scale||Standard Deviation|Mean
2815548|NCT00413777|Secondary|Mean Change From Baseline in MAP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
2815549|NCT00413777|Secondary|Mean Change From Baseline in dBP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
2815550|NCT00413777|Secondary|Mean Change From Baseline in sBP for Hypertension Assessment- Extension.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
2815551|NCT00413777|Secondary|Mean Change From Baseline in Mean Arterial Pressure (MAP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
2815552|NCT00413777|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (dBP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
2815736|NCT00413153|Secondary|Insulin Sensitivity|6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.|6 months|Repeated measures analysis using all available data points for each participant|||umol/kg/min per uU/mL insulin||Standard Deviation|Mean
2815553|NCT00413777|Secondary|Mean Change From Baseline in Systolic Blood Pressure (sBP) for Hypertension Assessment.|The participants were seated and resting systolic and diastolic BP for each scheduled assessment was recorded. At each assessment, participants were categorized (based on repeated blood pressure measurements as being normotensive (MAP < 100 mm Hg and off therapy), high normal (sBP > 129 and or dBP > 84 mm Hg off therapy) or hypertensive (sBP >140 and/or dBP > 90 mm Hg). The mean arterial pressure (MAP) was derived from these values and were not recorded (MAP = diastolic pressure + [1/3 x pulse pressure (ie systolic - diastolic pressure)] in mm Hg).|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mmHg||Standard Deviation|Mean
2815554|NCT00413777|Secondary|Change From Pre-dose Baseline in Renal Function Estimated by GFR- Extension.|GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration [mg/dL]). Clinic weight scales were calibrated at least yearly.|Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||dL/mg||Standard Deviation|Mean
2815555|NCT00413777|Secondary|Percent Change From Baseline in Renal Volume-Extension.|TKV was assessed by the central magnetic resonance imaging (MRI) rater.|Baseline to Months 2, 12, 24, 36, Extension Day 1, Extension Month 12|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Percentage change per month||Standard Deviation|Mean
2815556|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime- Extension.|"Urine osmolality at steady state (after at least 4 days of dosing) including average of troughs (the mean urine osmolality prior to bedtime).~Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
2815557|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose- Extension.|"Urine osmolality at steady state (after at least 4 days of dosing) including absolute trough prior to the second daily dose.~Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
2815558|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose- Extension.|Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36, Extension Day 1, and Extension Month 12 for all participants. Sample was taken after the first morning's void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting.|Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12|The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used.|||mOsm/kg||Standard Deviation|Mean
2815559|NCT00413777|Secondary|Change From Pre-dose Baseline in Renal Function Estimated by Glomerular Filtration Rate (GFR).|GFR was estimated using reciprocal serum creatinine formula. The formula does not adjust for body weight or height, but this may be done to normalize to body surface area. The formula for reciprocal Serum creatinine is: 1/Pcr. (Pcr = serum creatinine concentration [mg/dL]). Clinic weight scales were calibrated at least yearly.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||dL/mg||Standard Deviation|Mean
2815560|NCT00413777|Secondary|Percent Change From Baseline in Renal Volume.|Total Kidney Volume (TKV) was assessed by the central magnetic resonance imaging (MRI) rater.|Baseline to Month 36|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||Percentage change per month||Standard Deviation|Mean
2815561|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime.|"Urine osmolality at steady state (after at least 4 days of dosing) including average of troughs (the mean urine osmolality prior to bedtime).~Samples for this assessment were to be taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day at bedtime. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
2815663|NCT00413335|Primary|Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)|This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.|4 months||||percentage of participants|||Number
2815562|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose.|"Urine osmolality at steady state (after at least 4 days of dosing) including absolute trough prior to the second daily dose.~Samples for this assessment were taken as closely coincident to PK blood sample as practical. During Weeks 1, 2, 3 and 4 of the Titration Period and at Month 6, additional samples were collected for the preceding day immediately preceding the second daily dose. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration."|Baseline to Month 24|The ITT dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. OC dataset were used.|||mOsm/kg||Standard Deviation|Mean
2815563|NCT00413777|Secondary|Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose.|Spot urine osmolality at trough was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), Months 2, 6, 12, 24, 36 for all participants. Sample was taken after the first morning's void and was provided as a mid-stream, clean catch sample. During the titration period (Weeks 1, 2, 3 and 4) and at Month 6, additional samples were collected for the preceding day immediately preceding the 2nd daily dose and at bed-time. These samples allowed derivation of an average nadir of spot urine osmolality concentrations at each dose level and while at steady state during extended tolvaptan administration. At the Month 36 visit, participants were given a urine container and brought back the specimen at Extension Day 1. All participants were fasting.|Baseline to Month 36|The intent-to-treat (ITT) dataset was defined as a dataset that included data from all participants who enrolled to the study with observations at Baseline and Post Baseline. Observed cases (OC) dataset were used.|||mOsm/kg||Standard Deviation|Mean
2815564|NCT00413777|Primary|Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion.|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in a study , whether or not it was considered drug-related by the study physician. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study drug treatment; or if the event was continuous from Baseline and was serious, study drug related, or resulted in death, discontinuation.|AEs were recorded from screening (ICF was signed) until 7-Day follow-up|Safety dataset was defined as all participants who consumed at least 1 dose of study medication. Safety variables analyzed included physical examinations, laboratory tests, vital signs, ECG's and AEs.|||participants|||Number
2815565|NCT00413699|Secondary|Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4|Mean influenza antibody titers at visits 3 and 4.|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Antibody Titer||95% Confidence Interval|Geometric Mean
2815566|NCT00413699|Secondary|Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4|"Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.~ug/mL=micrograms per milliliter"|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Concentration (ug/mL)||95% Confidence Interval|Geometric Mean
2815567|NCT00413699|Secondary|Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4|"Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.~n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.~Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Fold Change in Antibody Level||95% Confidence Interval|Geometric Mean
2815568|NCT00413699|Secondary|Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4|"Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.~n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.~The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.~Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Fold Change in Antibody Level||95% Confidence Interval|Geometric Mean
2815569|NCT00413699|Secondary|Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4|"Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).~The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
2815570|NCT00413699|Secondary|Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4|"Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
2815571|NCT00413699|Secondary|Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4|"Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of ≥1:40 in ≥2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.~The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
2815572|NCT00413699|Secondary|Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers|"Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
2815573|NCT00413699|Secondary|Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations|"Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.~95% CI is based on Clopper-Pearson exact method for response rate."|From vaccine sub-study visit 2 (baseline) to sub-study visit 4|Evaluable Immunogenicity Population|||Percent of participants||95% Confidence Interval|Number
2815574|NCT00413699|Secondary|Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study|"Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.~TSS=Total Sharp Score"|Every 6 months until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Scores on a scale||Standard Deviation|Mean
2815575|NCT00413699|Secondary|Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)|"Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).~The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Scores on a scale||Standard Deviation|Mean
2815576|NCT00413699|Secondary|Initial Period: Short-Form-36 Health Survey (SF-36) Score|"Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were normed and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Scores on scale||Standard Deviation|Mean
2815577|NCT00413699|Secondary|Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Units on a scale||Standard Deviation|Mean
2815664|NCT00413335|Primary|Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat|This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.|4 months||||percentage of change from baseline||Standard Deviation|Mean
2815578|NCT00413699|Secondary|Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Units on scale||Standard Deviation|Mean
2815579|NCT00413699|Secondary|Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2|DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.|Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Percentage of participants|||Number
2815580|NCT00413699|Secondary|Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2|"Percent participants with DAS28-4 (ESR) <2.6 and ≤3.2 and percent participants with DAS28-3 (CRP) <2.6 and ≤3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.~DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.~The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission."|Every visit until study completion|Full Analysis Set - No Imputation. The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Percent of participants|||Number
2815581|NCT00413699|Secondary|Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12|DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.|Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Scores on a scale||Standard Deviation|Mean
2815582|NCT00413699|Secondary|Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])|"Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.~DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.~The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission."|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Score calculated from formula||Standard Deviation|Mean
2815583|NCT00413699|Secondary|Initial Period: Area Under American College of Rheumatology (ACR) n Curve|No data were collected for this endpoint because it was removed from the protocol in a previous amendment.|Not applicable as no data were collected for this endpoint.|No data were collected for this endpoint as it was removed from the protocol in a protocol amendment.||||||
2815591|NCT00413660|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815584|NCT00413699|Secondary|Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses|ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.|Month 3, 6, 9 and 12 of Extension Period|"Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories."|||Percentage of participants|||Number
2815585|NCT00413699|Secondary|Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses|The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.|Every visit until study completion|The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point.|||Percent of participants|||Number
2815586|NCT00413699|Primary|Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib|Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.|Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period|Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, “Number Analyzed” signifies number of participants evaluable for specified categories.|||Percentage of participants|||Number
2815587|NCT00413699|Primary|Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis|Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.|Includes AEs for every visit and up to 999 days after last dose of study drug|The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period.|||Number of participants|||Number
2815588|NCT00413699|Primary|Extension Period: Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN).|Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)|Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.|||Participants|||Count of Participants
2815589|NCT00413699|Primary|Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)|Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period.|||Participants|||Count of Participants
2815590|NCT00413699|Primary|Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports|"Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.~Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell"|Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug|For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study.|||Number of participants|||Number
2815592|NCT00413660|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815593|NCT00413660|Secondary|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815594|NCT00413660|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815595|NCT00413660|Secondary|Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815596|NCT00413660|Secondary|Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815597|NCT00413660|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815598|NCT00413660|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2825029|NCT00344461|Secondary|Changes in CD4 Cell Count From Baseline and Week 96|To determine the mean change from Baseline in CD4 cell count to week 96.|Baseline to week 96||||percentage of CD4 Increase||Standard Deviation|Mean
2815599|NCT00413660|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||percentage of participants|||Number
2815600|NCT00413660|Secondary|Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||percentage of participants|||Number
2815601|NCT00413660|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815602|NCT00413660|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815603|NCT00413660|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mg/dL||Standard Deviation|Mean
2815604|NCT00413660|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mg/dL||Standard Deviation|Mean
2815605|NCT00413660|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815606|NCT00413660|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2815607|NCT00413660|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
2816772|NCT00406393|Secondary|Rate of Veno-occlusive Disease (VOD)|VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.|Measured through Day 100||||percentage of participants||95% Confidence Interval|Number
2815608|NCT00413660|Secondary|Physician Global Assessment of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
2815609|NCT00413660|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
2815610|NCT00413660|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
2815611|NCT00413660|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
2815612|NCT00413660|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||mm||Standard Deviation|Mean
2815613|NCT00413660|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||swollen joints||Standard Deviation|Mean
2815614|NCT00413660|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||swollen joints||Standard Deviation|Mean
2815615|NCT00413660|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||tender joints||Standard Deviation|Mean
2815616|NCT00413660|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."|||tender joints||Standard Deviation|Mean
2815617|NCT00413660|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2815659|NCT00413374|Primary|Recurrent VTE|Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.|30 Days||||participants|||Number
2822960|NCT00361257|Secondary|Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)|The outcome was the 24 week change in CD4 cell count (week 24-baseline).|At baseline and weeks 24|The analysis was based on observed data.|||cells/mm^3||Standard Deviation|Mean
2815618|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2815619|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2815620|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2815621|NCT00413660|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).|||percentage of participants|||Number
2815622|NCT00413634|Secondary|Diastolic Blood Pressure|Diastolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population|||mmHg||Standard Deviation|Mean
2815623|NCT00413634|Secondary|Systolic Blood Pressure|Systolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population|||mmHg||Standard Deviation|Mean
2815624|NCT00413634|Primary|Vz/F of Active Metabolite||over 1 day|PK population|||L||Standard Deviation|Geometric Mean
2815625|NCT00413634|Primary|CL/F of Active Metabolite||over 1 day|PK population|||L/h||Standard Deviation|Geometric Mean
2815626|NCT00413634|Primary|T 1/2 of Active Metabolite||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
2815627|NCT00413634|Primary|AUC of Active Metabolite||over 1 day|PK population|||ng.h/ml||Standard Deviation|Geometric Mean
2815628|NCT00413634|Primary|Tmax of Active Metabolite||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
2815629|NCT00413634|Primary|Cmax of Active Metabolite|An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.|over 1 day|PK population|||ng/ml||Standard Deviation|Geometric Mean
2815630|NCT00413634|Primary|Volume of Distribution (Vz/F) of Agrylin||over 1 day|PK population|||L||Standard Deviation|Geometric Mean
2815631|NCT00413634|Primary|Total Clearance (CL/F) of Agrylin||over 1 day|PK population|||L/h||Standard Deviation|Geometric Mean
2815632|NCT00413634|Primary|Terminal Half-life (T 1/2) of Agrylin||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
2815633|NCT00413634|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin||over 1 day|PK population|||ng.h/ml||Standard Deviation|Geometric Mean
2815634|NCT00413634|Primary|Time of Maximum Plasma Concentration (Tmax) of Agrylin||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
2815635|NCT00413634|Secondary|Heart Rate|Heart rates in patients with ET receiving Agrylin|over 1 day|Safety population|||beats/min||Standard Deviation|Mean
2815636|NCT00413634|Secondary|Platelet Count|Platelet counts in patients with ET receiving Agrylin|over 1 day|Safety population (defined as all patients who received study treatment)|||x 1,000,000,000/L||Standard Deviation|Mean
2815637|NCT00413634|Primary|Maximum Plasma Concentration (Cmax) of Agrylin||over 1 day|PK population (defined as all patients with post-dose drug concentration data)|||ng/ml||Standard Deviation|Geometric Mean
2815638|NCT00413582|Secondary|Time in the Operating Room||1 week||||hours||Standard Deviation|Mean
2815639|NCT00413582|Primary|Length of Hospitalization||1 week||||days||Standard Deviation|Mean
2815640|NCT00413478|Primary|Tumor Response Rate (Complete, Partial) of Azacytidine|Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count > 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be > 11g/dl without transfusions. Lymphocyte count <4000/micL. On bone marrow aspirate lymphocyte % should be <30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils > 1500/ micL or >50 % improvement from baseline, platelet count >100,000/micL or >50 % improvement from baseline. Hemoglobin >11g/dl or >50% improvement from baseline. A reduction of >50% in Leukocyte count or <30 % lymphocytes with residual disease on biopsy for nodular PR.|3 to 8 weeks treatment cycles, continuation up to 1 year||||percentage of participants|||Number
2824141|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method||||||
2815641|NCT00413413|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
2815642|NCT00413413|Secondary|Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)|Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
2815643|NCT00413413|Secondary|Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)|A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
2815644|NCT00413413|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
2815645|NCT00413413|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
2815646|NCT00413400|Secondary|Adipocyte Messenger Ribonucleic Acid (mRNA) Levels of Adipocytokines Including Tumor Necrosis Factor (TNF) -Alpha|fold-change in subcutaneous adipose tissue expression of TNF-alpha (mRNA) after 6 months|6 months||||fold-change||Standard Error|Mean
2815647|NCT00413400|Secondary|Lipid Levels|total cholesterol (mg/dL) at 6 months|6 months||||mg/dL||Standard Error|Mean
2815648|NCT00413400|Secondary|Other Adipocytokines|circulating resistin at 6 months|6 months||||ng/mL||Standard Error|Mean
2815649|NCT00413400|Secondary|Tumor Necrosis Factor (TNF) Receptor|Circulating concentrations of Tumor necrosis factor receptor 2 (TNFR2) at 6 months|6 months||||pg/mL||Standard Error|Mean
2815650|NCT00413400|Secondary|Body Composition|6 month visceral adipose tissue (cm^2) - cross-sectional area of the visceral adipose tissue at the level of the 4th lumbar vertebrae was measured using single-slice abdominal computed tomography (CT) scan|6 months||||cm^2||Standard Error|Mean
2815651|NCT00413400|Secondary|Cardiac Echo Ejection Fraction (EF)|change in EF (6mo - baseline). Please note that the value given is the absolute change in EF (which has units of percent), not the percent change in the variable.|Baseline to 6 months||||percent||Standard Error|Mean
2815652|NCT00413400|Secondary|White Blood Cell (WBC) Count|Change in WBC during study (WBC at six months minus WBC at baseline)|Baseline to 6 months||||th/cumm||Standard Error|Mean
2815653|NCT00413400|Secondary|Endothelial Function|Reactive Hyperemia Index (RHI) using peripheral artery tonometry (using Endo-PAT 2000). Peripheral artery tonometry measures blood flow in the tip of the index finger at baseline and in response to vaso-occlusion (inflated blood pressure cuff). The reactive hyperemia index is an index of vasodilation after occlusion compared to baseline. A higher value indicates better vasoreactivity. As this is a relatively new test, there are no thoroughly validated clinically utilized norms.|6 months||||(index)||Standard Error|Mean
2815654|NCT00413400|Secondary|Glucose Tolerance|Fasting glucose (mg/dL) at 6mo|6 months||||mg/dL||Standard Error|Mean
2815655|NCT00413400|Primary|Adiponectin|The ratio of circulating high molecular weight (HMW) adiponectin to total adiponectin ratio (HMW:total Adiponectin) at 6 months is reported.|6 months||||(ratio)||Standard Error|Mean
2815656|NCT00413400|Primary|Interleukin-6 (IL-6)|6 month value of IL-6 (pg/mL)|6 months||||pg/mL||Standard Error|Mean
2815657|NCT00413400|Primary|C-reactive Protein (CRP)|As a measure of C-reactive protein (CRP), which is an inflammatory marker, Log10 of the CRP at 6 months is reported|6 months||||Log10 mg/L||Standard Error|Mean
2815658|NCT00413374|Primary|Death|All-cause mortality|30 Days|Intention to treat|||Participants|||Count of Participants
2815665|NCT00413335|Primary|Mean Percent Change From Baseline in Whole-body Insulin Sensitivity|This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).|4 months||||percentage of change from baseline||Standard Deviation|Mean
2815666|NCT00413283|Secondary|Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle|Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.|8 days|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.|||Participants|||Number
2815667|NCT00413283|Secondary|Platelet Count on Day 22|Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group|Day 22|Efficacy Analysis Set, composed of all randomized participants except those who were replaced|||10^9/L||Standard Deviation|Mean
2815668|NCT00413283|Secondary|Number of Participants With Platelet Transfusions|Number of participants who were administered platelet transfusions during first on study treatment cycle.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.|||Participants|||Number
2815669|NCT00413283|Secondary|Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.|The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.|||Participants|||Number
2815670|NCT00413283|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).|||days||Standard Deviation|Mean
2815671|NCT00413283|Primary|Number of Participants With Adverse Events|This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.|4 months|Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.|||Participants|||Number
2815672|NCT00413244|Secondary|IIEF-V: Over-all Satisfaction|Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2815673|NCT00413244|Secondary|IIEF-IV: Intercourse Satisfaction|Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2815674|NCT00413244|Secondary|IIEF -III: Sexual Desire|Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2815675|NCT00413244|Secondary|IIEF-II Orgasmic Function|Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2815676|NCT00413244|Secondary|International Index of Erectile Function (IIEF)|Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2815677|NCT00413244|Secondary|Aging Male Symptoms (AMS)|The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)|At baseline, 1 month, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2815678|NCT00413244|Secondary|Metabolic Equivalents of Task (METS)|The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg−1·min−1 or equivalently|6 months|Subjects analyzed were only those subjects with ST depression at baseline|||METS units||Standard Deviation|Mean
2815679|NCT00413244|Secondary|International Prostate Symptom Score (IPSS)|"IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 (delighted to terrible.) Data not collected."|6 months|||||||
2815680|NCT00413244|Secondary|Reactive Hyperemia Index|The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.|6 months|Subjects analyzed were only those subjects with ST depression at baseline|||mls||Standard Deviation|Mean
2815681|NCT00413244|Secondary|Seattle Angina Questionnaire (SAQ)|"A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.~Data not collected."|up to 6 months|||||||
2815682|NCT00413244|Primary|Cardiac Stress Testing: Exercise Capacity|Exercise capacity was measured using exercise time.|At 1 month, 3 months, and 6 months|Subjects analyzed were only those subjects with ST depression at baseline|||seconds||Standard Deviation|Mean
2815683|NCT00413244|Primary|Cardiac Stress Test: Time to ST Depression|Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.|at 6 months|Subjects analyzed were only those subjects with ST depression at baseline|||seconds||Standard Deviation|Mean
2815684|NCT00413231|Secondary|Percentage of Participants That Experienced Loss of Stent Graft Patency|Percentage of subjects that experienced loss of stent graft patency within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815685|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)|Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815686|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures|Percentage of subjects that experienced secondary endovascular procedures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815687|NCT00413231|Secondary|Percentage of Participants That Experienced Type IV Endoleaks|Percentage of subjects that experienced type IV endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815688|NCT00413231|Secondary|Percentage of Participants That Experienced Type III Endoleaks|Percentage of subjects that experienced type III endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815689|NCT00413231|Secondary|Percentage of Participants That Experienced Type I Endoleaks|Percentage of subjects that experienced type I endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815690|NCT00413231|Secondary|Percentage of Participants That Experienced Conversions to Open Surgical Repair|Percentage of subjects that experienced conversions to open surgical repair within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815691|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm Ruptures|Percentage of subjects that experienced aneurysm ruptures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815692|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815693|NCT00413231|Secondary|Percentage of Participants That Died (All-cause Mortality)|Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants|||Number
2815694|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months|||Percentage of participants||95% Confidence Interval|Number
2815695|NCT00413231|Secondary|Percentage of Participants That Experience Loss of Stent Graft Patency|Percentage of subjects that experience loss of stent graft patency within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging|||Percentage of participants||95% Confidence Interval|Number
2815696|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migration|Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging|||Percentage of participants||95% Confidence Interval|Number
2815697|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak|Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months|Between 30 days and 12 months|Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)|||Percentage of participants||95% Confidence Interval|Number
2815698|NCT00413231|Secondary|Percentage of Participants That Experienced Endoleak(s)|Percentage of subjects that experienced endoleak(s) of any type at 12 months|At 12 months|Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks|||Percentage of participants||95% Confidence Interval|Number
2815699|NCT00413231|Secondary|Percentage of Participants That Experienced Conversion to Open Surgical Repair|Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects exited before 12 months|||Percentage of participants||95% Confidence Interval|Number
2815700|NCT00413231|Secondary|Percentage of Participants That Experience Aneurysm Rupture|Percentage of subjects that experience aneurysm rupture within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months|||Percentage of participants||95% Confidence Interval|Number
2815701|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures|||Percentage of participants||95% Confidence Interval|Number
2815702|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
2815703|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge|Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
2815704|NCT00413231|Secondary|Percentage of Participants That Experienced Paraparesis|Percentage of subjects that experienced paraparesis within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
2815705|NCT00413231|Primary|Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >|"The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated.~>~> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks."|Within 12-months post treatment|Subjects treated or intended to treat with the test device|||Percentage of Participants||95% Confidence Interval|Number
2815706|NCT00413231|Primary|Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)|"Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b.~Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device.~Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak)."|At 12-month post procedure|Subjects treated or intended to treat with the test device|||Percentage of Participants||95% Confidence Interval|Number
2815707|NCT00413231|Secondary|Percentage of Participants That Experienced Paraplegia|Percentage of subjects that experienced paraplegia within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
2815708|NCT00413231|Secondary|Percentage of Participants That Experienced Perioperative Mortality|Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.|Within 30 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
2815709|NCT00413231|Secondary|Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant|Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.|At implant|Subjects treated or intended to treat with the test device|||Percentage of participants||95% Confidence Interval|Number
2815710|NCT00413231|Primary|Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)|Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device|||Percentage of participants||90% Confidence Interval|Number
2815711|NCT00413218|Secondary|Time to First Confirmed Negative Culture|The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis|Day 1 up to FU1 (2 weeks after EOT (Day 56))|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.|||Days||95% Confidence Interval|Median
2815712|NCT00413218|Secondary|All-Cause Mortality (ACM) at Day 14 and Day 56|All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.|Day 14 and Day 56|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.|||Percentage of Participants|||Number
2815713|NCT00413218|Secondary|Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator|Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.|Day 7 and EOT (Day 56)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole|||Percentage of Participants|||Number
2815714|NCT00413218|Secondary|Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator|Success was defined as mycological response (eradication or presumed eradication).|Day 7 and EOT (Day 56)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
2824142|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2815715|NCT00413218|Secondary|Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).|EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
2815716|NCT00413218|Secondary|Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).|EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
2815717|NCT00413218|Secondary|Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).|EOT (Day 56) and FU2 (6 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
2815718|NCT00413218|Secondary|Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)|A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.|End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)|The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.|||Percentage of Participants|||Number
2815719|NCT00413218|Primary|Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use|A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.|End of Intravenous Treatment (EOIV) (Days 11-56)|The ITT population consisted of all randomized participants who received at least one dose of study drug. The mITT population consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. Reporting arms included participants who switched to oral ISA and CAS.|||Percentage of Participants|||Number
2815720|NCT00413192|Secondary|Summary of Adverse Events (AEs)|Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. TEAEs are defined as an adverse event (AE) that emerged during treatment, having been absent at baseline or: reemerged during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. All AEs and SAEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. A participant was counted only once within a System Organ Class (SOC) and preferred term (PT), even if the participant experienced more than one TEAE with a specific SOC and PT. Participants were summarized by treatment group according to the worst CTCAE grade assigned for each PT. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing relationship.|Day 1 of study treatment until progressive disease, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years|Safety analysis set included all participants who received at least one dose of study drug, regardless of their eligibility to enter the study.|||Percentage of participants|||Number
2815721|NCT00413192|Secondary|Overall Survival (OS)|Participants still alive at the end of the study had their time to event censored at the day last known to be alive. Participants lost to follow-up were also censored at the date last known to be alive. 95% CIs for the percentage of participants still alive at the end of the study were presented as described for the primary endpoint, PFS at Week 12.|Date of first dose of study drug to date of death from any cause, or up to cut-off date of 28 Jun 2012, up to approximately 5.5 years|EES|||Days||95% Confidence Interval|Median
2815733|NCT00413153|Secondary|Body Composition - Visceral Adipose Tissue|6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).|6 months|Data from participants with 0 & 6 month data analyzed.|||square centimeters||Standard Deviation|Mean
2815722|NCT00413192|Secondary|Duration of Response|"Duration of response could be calculated only if a participant achieved a BOR of CR or PR, as defined previously. For consistency with the formula used by the European Organization for Research and Treatment of Cancer (EORTC), the duration was derived as day of event minus day of first documented CR or PR (one was not added to the calculation). Participants who were alive without documented progression had their duration of response censored at the day of last follow-up for progression. Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the duration of response by strata. No adjustment was made for participants who started further anticancer therapy prior to disease progression."|Date of first documented CR or PR until the date of first document disease progression (or death), or up to data cutoff 28 Jun 2012, up to approximately 5.5 years|EES|||Days||95% Confidence Interval|Median
2815723|NCT00413192|Secondary|Time to Onset of Response|Time to onset of response could be calculated only if a participant achieved an objective response (BOR of CR or PR as defined previously). Participants who never achieved CR or PR were not included in the Kaplan-Meier survival estimates for the time to onset of response by strata. Given the small number of participants with these responses and the large variation in time to onset of response between participants, no comparison could be made among the strata.|Date of first dose of study drug to date of first documented CR or PR, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years|EES|||Days||95% Confidence Interval|Median
2815724|NCT00413192|Secondary|Clinical Response Benefit (CRB)|CRB was defined as the percentage of participants with a BOR of CR or PR or SD as defined by RECIST, described previously. BOR was derived using the same hierarchy as used when determining the status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. CRB = CR + PR + SD|Date of first dose of study drug to documentation of CR, PR, or SD, or until data cutoff date 28 Jun 2012, up to approximately 5.5 years|EES|||Percentage of participants||95% Confidence Interval|Number
2815725|NCT00413192|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis set who had a BOR of CR or PR based on RECIST v. 1.0 for target lesions. Tumors were assessed using x-rays, magnetic resonance imaging (MRI), or computed tomography (CT) scans, or both, as appropriate. ORR was documented and confirmed by two measurements taken at least 4 weeks apart. CR was defined as the disappearance of all target lesions. PR defined as ≥ 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Best overall response was derived using the same hierarchy as used when determining the PFS status at Week 12. No adjustments were made for participants who started further anticancer therapy prior to disease progression. 95% CIs were calculated using the exact method of binomial distribution. ORR = CR + PR|Date of first dose of study drug until documentation of CR or PR, or up to data cutoff 28 Jun 2012, up to approximately 5.5 years|EES|||Percentage of participants||95% Confidence Interval|Number
2815726|NCT00413192|Secondary|Overall Progression Free Survival|Overall PFS was determined from any evidence that the participant had progressed, along with whether or not the participant was still alive at the end of the study. Tumors were evaluated every 6 weeks during treatment, and at least 4 weeks after the first observation of a complete or partial response. After discontinuation of study drug, participants without PD were re-evaluated every 12 weeks, unless a new anticancer therapy was started. Participants were considered as having progressed if they were classed as PD at Week 12, or had a best overall response (BOR) of PD, or had a date of progression, if they discontinued due to PD, died due to PD, or if the PI had recorded a date of progression. A participant was determined progression free if they were alive without PD at the time of study cut-off. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided CIs for the percentage of successes.|First dose of study drug to the date of disease progression or date of death, whichever occurs first, or date of study cut-off 28 Jun 2012, up to 5.5 years|EES|||Days||95% Confidence Interval|Median
2815727|NCT00413192|Primary|Progression Free Survival (PFS) at 12 Weeks|PFS was determined from the Week 12 visit tumor scan and the participant's date of death. Progression was defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), early death from any cause, or not assessable according to Response Evaluation Criteria In Solid Tumors (RECIST). CR defined as the loss of all target lesions. PR defined as ≥ 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PD defined as ≥ 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since treatment started. The number and percentage of successes were summarized by stratum and overall, together with 95% 2-sided confidence intervals (CIs) for the percentage of successes.|Week 12|Efficacy evaluable set (EES) consisted of all registered, eligible subjects who had received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2815728|NCT00413166|Primary|Complete Response (CR) Rate|"Response defined as CR (marrow with <5% blasts and no abnormal promyelocytes together with neutrophil count >1000 and platelet count >100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy.~Bone marrow aspirate performed to check the status of the disease."|1 month, up to day 85 of treatment|Of the 57 participants treated on the ATRA + ATO: Low Risk treatment arm, 56 participants were evaluable for response.|||Participants|||Count of Participants
2815729|NCT00413153|Secondary|Total Bilirubin|6 month mean and standard deviation for total bilirubin.|6 months|Repeated measures analysis using all available data points for each participant|||mg/dL||Standard Deviation|Mean
2815730|NCT00413153|Secondary|Liver Enzymes -- Alanine Aminotransferase (ALT)|6 month mean and standard deviation for ALT.|6 months|Repeated measures analysis using all available data points for each participant|||U/L||Standard Deviation|Mean
2815731|NCT00413153|Secondary|Liver Enzymes -- Aspartate Aminotransferase (AST)|6 month mean and standard deviation for AST.|6 months|Repeated measures analysis using all available data points for each participant|||U/L||Standard Deviation|Mean
2815732|NCT00413153|Secondary|Immune Parameters -- CD4 Count|6 month mean and standard deviation for CD4+ count.|6 months|Repeated measures analysis using all available data points for each participant|||cells/microL||Standard Deviation|Mean
2824143|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2815737|NCT00413153|Primary|Glucose Trafficking|"6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or trafficked to) muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity."|6 months|Only data from subjects with 0 and 6 month Positron Emission Tomography (PET) scans were analyzed.|||umol/kg/min||Standard Deviation|Mean
2815738|NCT00413062|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
2815739|NCT00413062|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."|||days||Standard Deviation|Mean
2815740|NCT00413062|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.|||participants|||Number
2815741|NCT00413062|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period.~Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2815742|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2815743|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2815812|NCT00412867|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months|The number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months after onset||||participants|||Number
2815744|NCT00413062|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2815745|NCT00413062|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
2815746|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."|||participants|||Number
2815747|NCT00413062|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."|||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
2815748|NCT00413049|Secondary|Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)|Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)||||mmHg||Standard Deviation|Mean
2815749|NCT00413049|Secondary|Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)|A patient achieved overall control if the msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
2815750|NCT00413049|Secondary|Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)|A patient achieved diastolic control if their msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
2815759|NCT00413010|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Total Score|Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||score on scale||Standard Error|Least Squares Mean
2815751|NCT00413049|Secondary|Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)|A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||Percentage of patients|||Number
2815752|NCT00413049|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
2815753|NCT00413049|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.|||mmHg||Standard Error|Least Squares Mean
2815754|NCT00413036|Secondary|Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease."|Up to 1459 days|Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.||||||
2815755|NCT00413036|Secondary|Progression-free Survival as Determined by Central Review|"Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population|||Months||95% Confidence Interval|Median
2815756|NCT00413036|Secondary|Time to Progression as Determined by Central Review|"Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population|||Months||95% Confidence Interval|Median
2815757|NCT00413036|Secondary|Duration of Response as Determined by Central Review|"Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.~For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting."|Up to 1459 days|Intent-to-treat population|||Months||95% Confidence Interval|Median
2815758|NCT00413036|Primary|Participants Categorized by Best Response as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population|||Participants|||Number
2815760|NCT00413010|Secondary|Clinical Global Impression of Severity (CGI-S) Score|CGI-S is a clinician-rated instrument measuring the severity of a subject's symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
2815761|NCT00413010|Secondary|Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score|Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
2815762|NCT00413010|Secondary|Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement|Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment. CI for placebo patients was not estimable.|||days||95% Confidence Interval|Median
2815763|NCT00413010|Secondary|Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score|Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
2815764|NCT00413010|Secondary|Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)|Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.|||participants|||Number
2815765|NCT00413010|Secondary|Change in HAM-A Total Score at Weekly Visits|Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.|||score on scale||Standard Error|Least Squares Mean
2815766|NCT00413010|Primary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.|||score on scale||Standard Error|Least Squares Mean
2815767|NCT00412984|Other Pre-specified|Rate of Net-Clinical Benefit During Treatment Period|Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||Number of events per 100 patient years|||Number
2815768|NCT00412984|Other Pre-specified|Number of Participants With Net-Clinical Benefit During Treatment Period|Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
2815769|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period|Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with ≥5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with ≥3 gm/dL fall in Hgb or a ≥10% fall in Hct from baseline, accounting for transfusions.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.|||Number of events per 100 patient years|||Number
2815776|NCT00412984|Secondary|Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period||"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date, last contact date, or the efficacy cut-off date (30-Jan-2011).|||Number of events per 100 patient years|||Number
2815770|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period|Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.|||Number of events per 100 patient years|||Number
2815771|NCT00412984|Secondary|Rate of All Bleeding Events During Treatment Period|"Rate=number of all bleeding events per 100 patient years. All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death."|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||number of events per 100 patient years|||Number
2815772|NCT00412984|Secondary|Number of Participants With All Bleeding Events During Treatment Period|All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
2815773|NCT00412984|Secondary|Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period|Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||number of events / 100 patient years|||Number
2815774|NCT00412984|Secondary|Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period|Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
2815775|NCT00412984|Other Pre-specified|Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period|AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
2815810|NCT00412867|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score|from 0 (normal) to 40 (most severe)|within 6 hours, from 24 to 36 hours, 3 months after onset.|Two participants (from 24 to 36 hours) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data|||units on a scale||Full Range|Median
2815777|NCT00412984|Secondary|Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period|For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants who were Warfarin/Vitamin K Antagonist (VKA) naïve (a stratification variable, defined as receiving ≤30 consecutive days of prior warfarin/VKA treatment). Participants not experiencing efficacy endpoint event were censored at earlier of death, last contact, or efficacy cut-off date (30-Jan-2011).|||participants|||Number
2815778|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I ≥ 2 × the ULN, or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who didn't experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n= number of participants experiencing stated combination of events.|||Number of events per 100 patient years|||Number
2815779|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I ≥ 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n=number of participants experiencing stated event.|||Number of events per 100 patient years|||Number
2815780|NCT00412984|Secondary|Rate of Adjudicated All-Cause Death During the Intended Treatment Period|All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||Number of events per 100 patient years|||Number
2815781|NCT00412984|Secondary|Number of Participants With Events of All-Cause Death During the Intended Treatment Period|Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||participants|||Number
2815782|NCT00412984|Secondary|Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period|Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||Number of events per 100 patient years|||Number
2815811|NCT00412867|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours after starting treatment||||participants|||Number
2815849|NCT00412542|Primary|Number of Participants Progression Free at 6 Months With Malignant Gliomas|Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.|6 Months|7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).|||participants|||Number
2815783|NCT00412984|Secondary|Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period|ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.|||participants|||Number
2815784|NCT00412984|Primary|Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period|Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||Number of events per 100 patient years|||Number
2815785|NCT00412984|Primary|Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period|All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Time to first event in Intended Treatment Period: started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).|||participants|||Number
2815786|NCT00412971|Secondary|False Positive Detection Rate Patient Level||12 months||||percent of patients|||Number
2815787|NCT00412971|Secondary|Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.||At day 0|ITT|||percentage of participants||95% Confidence Interval|Number
2815788|NCT00412971|Primary|Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.|To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.|1 year|PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.|||precentage of participants||95% Confidence Interval|Number
2815789|NCT00412958|Primary|Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect|The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.|Day 7|Intent-To-Treat (ITT). Full Analysis Set.|||percentage of participants|||Number
2815790|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||participants|||Number
2815791|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||participants|||Number
2824144|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2815792|NCT00412932|Secondary|Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||participants|||Number
2815793|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had baseline and week 12 ABPM measurements.|||mm Hg||Standard Error|Mean
2815794|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2815795|NCT00412932|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2815796|NCT00412932|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2815797|NCT00412893|Secondary|Number of Participants With Adverse Events, Reported by System Organ Class||From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.|The safety analysis set consists of all randomized patients who received at least one dose of study drug according to the study drug that the participant actually received as the first dose. One participant was randomized to isavuconazole but received voriconazole treatment for the first 7 days and is included in the voriconazole arm for safety.|||participants|||Number
2815798|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the Investigator|"Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."|||percentage of participants|||Number
2815799|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the Investigator|"Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as Not Applicable.~End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."|||percentage of participants|||Number
2815800|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the Investigator|"Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."|||percentage of participants|||Number
2815801|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the DRC|"Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.~Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. A participant with no post-baseline radiology data with evidence of radiologic disease at Baseline was considered a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."|||percentage of participants|||Number
2815802|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the DRC|"Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as Not Applicable.~End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded.|||percentage of participants|||Number
2815803|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the DRC|"Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."|||percentage of participants|||Number
2815804|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator|Overall response based on investigators' assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|||||||
2815805|NCT00412893|Secondary|All-cause Mortality Through Day 84|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.|Through Day 84|Intent-to-treat population|||percentage of participants|||Number
2815806|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)|"The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.~Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).~End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified Intent-to-treat (mITT) population consisted of ITT participants who had proven or probable IFD as determined by the DRC.|||percentage of participants|||Number
2815807|NCT00412893|Primary|All-cause Mortality Through Day 42|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.|Through Day 42|Intent-to-treat population|||percentage of participants|||Number
2815808|NCT00412867|Secondary|Percentage of Participants With Adverse Events and Adverse Drug Reactions||3 months||||percentage of patients|||Number
2815809|NCT00412867|Secondary|Barthel Index (BI)|from 100 (Independent) to 0 (full assistance)|the day of discharge within 3 months after onset, and 3 months after onset|Eleven participants (the day of discharge within 3 months after onset) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data|||units on a scale||Standard Deviation|Mean
2815813|NCT00412867|Primary|Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)|"Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in <50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory.~The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization."|within 6 hours, from 24 to 36 hours after onset||||participants|||Number
2815814|NCT00412854|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From receipt of first dose of study vaccine (Day 0) to study end (Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Subjects|||Number
2815815|NCT00412854|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Subjects|||Number
2815816|NCT00412854|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Subjects|||Number
2815817|NCT00412854|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Subjects|||Number
2815818|NCT00412854|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2815819|NCT00412854|Secondary|Concentrations for Anti-PRP Antibodies|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2815820|NCT00412854|Secondary|Concentrations for Anti-D and Anti-T Antibodies|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2815821|NCT00412854|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL|The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2815822|NCT00412854|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies|"The vaccine response was defined as it follows:~for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;~for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2815823|NCT00412854|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2824145|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2815824|NCT00412854|Primary|Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2815825|NCT00412841|Secondary|To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)||6 years|Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.||||||
2815826|NCT00412841|Secondary|To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients||6 years|Study Terminated. No data available for analysis. Secondary Outcome measure was not included in analysis.||||||
2815827|NCT00412841|Secondary|Number of Participants With AVN After 4 Months||4 months||||participants|||Number
2815828|NCT00412841|Primary|Number of Participants With AVN After 9 Months||9 months||||participants|||Number
2815829|NCT00412750|Primary|Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)|The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24.|Weeks 12 and 24|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week."|||Percentage of participants|||Number
2815830|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.|||percentage of participants|||Number
2815831|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.|||Percentage of participants|||Number
2815832|NCT00412750|Secondary|Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion|HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC).|Weeks 18, 24, 48, 52 and Treatment completion (TC)|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week and on treatment completion (TC)."|||Percentage of participants|||Number
2815833|NCT00412750|Secondary|Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52|The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA >= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA >= 1 log10 copies/mL from nadir on two consecutive visits.|Weeks 48 and 52|Intent to treat (ITT) population. As most patients did not reach Week 48 and Week 52, the LOCF was used.|||Percentage of participants|||Number
2815834|NCT00412750|Secondary|Change From Baseline in HBV DNA Concentration|The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors.|Weeks 12 and 24|Intent to Treat (ITT) population. n= the number of patients who have both baseline and post baseline observation for the respective week|||log 10 copies/ml||Standard Error|Least Squares Mean
2815835|NCT00412750|Primary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy|The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|At week 52|The analysis was planned on intention to treat (ITT) population. Due to premature study termination, the analysis was not performed.|||Percentage of participants|||Number
2815836|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.|||participants|||Number
2815837|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.|||participants|||Number
2824146|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2815838|NCT00412737|Secondary|Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.|||participants|||Number
2815839|NCT00412737|Secondary|Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.|||participants|||Number
2815840|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.|||participants|||Number
2815841|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.|||participants|||Number
2815842|NCT00412737|Primary|Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.|||participants|||Number
2815843|NCT00412607|Secondary|Change in Left Ventricular Ejection Fraction at 6 Month From Baseline|Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.|6-month follow up|Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.|||percentage of blood leaving the heart||Standard Deviation|Mean
2815844|NCT00412607|Secondary|Number of Subjects Achieved Long-term Efficacy Success|Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.|3-year follow up|Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.|||participants|||Number
2815845|NCT00412607|Secondary|Percentage of Subjects Who Achieved Chronic Effectiveness|Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.|6-month follow up|Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included|||Percentage of participants|||Number
2815846|NCT00412607|Primary|The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.|The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.|Seven days post ablation procedure|Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.|||percentage of Adverse Event||95% Confidence Interval|Number
2815847|NCT00412607|Secondary|Percentage of Subjects Achieved Acute Success|Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.|Duration from post-procedure to hospital discharge, up to 2 days|Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.|||Percentage of participants|||Number
2815848|NCT00412607|Primary|The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.|The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.|12-month post ablation|Safety analysis population - subjects who underwent insertion of the study catheter.|||percentage of mortality||95% Confidence Interval|Number
2824174|NCT00352053|Secondary|Change From Baseline to Week 288 in HIV-1 RNA||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
2815850|NCT00412529|Secondary|Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative|PCR negative was considered <300 copies/mL. PCR positive was considered =>300 copies/mL.|At Week 12|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||Participants|||Number
2815851|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production|Viral kinetic parameters were estimated with a bi-phasic mathematical model of HBV DNA by using compartments of free virus, infected cells, and uninfected target cells. The model parameter of interest was the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε). Blocking efficiency was within the range between 0 and 1.|Baseline to 12 weeks|Intent to Treat (ITT) population.|||percentage of blocking efficiency||Standard Deviation|Mean
2815852|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:~V(t) = (1-ε)pI(t) - cV(t)~I(t) = (1- η)TV(t) - δI(t)~V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population. The value for the rate of infected cell loss for 1 patient in telbivudine arm was not used in calculation of summary statistics for this variable as this patient showed a deviation from the biphasic pattern in viral kinetic modeling.|||infected cell loss per day||Standard Deviation|Mean
2815853|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:~V(t) = (1-ε)pI(t) - cV(t)~I(t) = (1- η)TV(t) - δI(t)~V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population.|||clearance per day||Standard Deviation|Mean
2815854|NCT00412529|Secondary|Change in Alanine Aminotransferase (ALT) Levels||From Baseline to Week 12|Intention to treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||IU/L||Standard Deviation|Mean
2815855|NCT00412529|Secondary|The Area Under the Curve (AUC) of HBV DNA Change.|In AUC efficacy analyses, all the visits from baseline to Week 12 visit (including the planned and the repeated) with a non-missing HBV DNA level were included.|From Baseline to Week 12|Intention-to-treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||(log10 copies/mL) * days||Standard Deviation|Mean
2815856|NCT00412529|Secondary|Change in Mean HBV DNA Level|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.HBV DNA reductions, considered as the repeated measures, from baseline to Weeks 2, 4, 8.|Baseline (day 1) to Weeks 2, 4, 8|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||log10 copies/mL||Standard Deviation|Mean
2815857|NCT00412529|Primary|Change in Mean Hepatitis B Virus (HBV) DNA Levels|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.|Baseline (day 1) to Week 12 (day 85)|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.|||log10 copies/mL||Standard Deviation|Mean
2815858|NCT00412516|Secondary|Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus|12, 24, 36 months post-JE vaccination||||GMT||95% Confidence Interval|Mean
2815859|NCT00412516|Secondary|Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|"Seropositive defined as a person with neutralizing antibody against JE virus at a titer ≥ 1:10 in a 50% plaque-reduction neutralizing assay (PRNT-50)"|12 months, 24 months, and 36 months post vaccination||||percentage of subjects seropositive||95% Confidence Interval|Number
2815860|NCT00412516|Secondary|Measles Seropositivity at 12 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|12 months post vaccination||||percentage of subjects seropositive||95% Confidence Interval|Number
2815861|NCT00412516|Primary|Measles Seropositivity at 24 and 36 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|24, 36 months post vaccination||||percentage of participants seropositive||95% Confidence Interval|Number
2815862|NCT00412464|Primary|Thrombocytopenic Events|Patient's platelet counts should be kept above 50 x 10^9/L while on study with platelet transfusions as needed with the exception of patients enrolled under the HIT/ suspicion of HIT inclusion (platelet transfusions are contraindicated in HIT). With regards to study patients who experience progressive decreases in platelet count to below 50 x 10^9/L while receiving fondaparinux (excluding patients being treated for HIT or suspicion of HIT), fondaparinux will be discontinued.|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
2815876|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Baseline|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815863|NCT00412464|Primary|Adverse Events|Adverse events will be defined as any untoward or unexpected event which can be a symptom, physical exam sign or laboratory abnormality. Adverse events will be classified as serious if they lead to prolonged hospitalization, re-hospitalization, transfer to an intensive care unit, or death. Adverse events will be categorized in terms of their likely association with fondaparinux as probably related, possibly related, unrelated, or unknown, and will be recorded according to standard adverse reporting guidelines for clinical trials.|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
2815864|NCT00412464|Primary|Bleeding Events|Bleeding assessment Patients will be monitored for bleeding symptoms by physician and nursing assessment. Major bleeding will be defined as bleeding which is in a critical space (intracranial, retroperitoneal, or visceral) or leads to the need for blood transfusion. Minor bleeding will be all other bleeding and will be classified as clinically significant (i.e. If the physician has to take action to treat the minor bleed) or clinically insignificant (i.e. if the physician does not need to intervene to treat the minor bleed).|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
2815865|NCT00412464|Primary|Therapeutic Plasma Concentration of Fondaparinux at 21 Days|Subjects all had detailed pharmacokinetic measurements done which were subsequently analyzed in a population pharmacokinetic model. This model then informed the dosing recommendations that were published as a result of the study.|21 days||||mg/dL||Standard Deviation|Mean
2815866|NCT00412464|Primary|Number of Abnormal Lab Results Resulting in Adverse Events.|The primary outcome measure was assessment of safety by reporting the number of abnormal lab results resulting in adverse events. Safety laboratory assessments are as follows: Liver and kidney toxicity will be determined by serial measurements of AST, ALT, total bilirubin, BUN and creatinine. Hematologic toxicity will be assessed by serial CBCs.|Study period which was up to 21 days of fondaparinux||||Adverse Events|||Number
2815867|NCT00412451|Primary|PVD Induction|The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)|Day 14 post-injection|Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2815868|NCT00412425|Primary|Cumulative Participants Response to Palonosetron|Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.|7 days|Analysis was per protocol.|||episodes of nausea/vomiting|||Number
2815869|NCT00412373|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815870|NCT00412373|Other Pre-specified|Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815871|NCT00412373|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815872|NCT00412373|Other Pre-specified|Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815873|NCT00412373|Secondary|Participants With Response|Response is defined as a 30% or more reduction from baseline PANSS total score and CGI-C score of <= 2 (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder).|Week 6 LOCF End Point|Intent-to-Treat|||participants|||Number
2815874|NCT00412373|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|"The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to No change. Ratings of <4 are equivalent to improvement and ratings of > 4 are equivalent to worsening. Higher scores indicate worsening."|Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815875|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815877|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815878|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815879|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815880|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815881|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815882|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815883|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815884|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat|||points on a scale||Standard Deviation|Mean
2815885|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.|||points on a scale||Standard Deviation|Mean
2815886|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.|||points on a scale||Standard Deviation|Mean
2815887|NCT00412360|Secondary|Number of Participants With Engraftment Syndrome||Day 100 post-transplant|Transplanted participants|||Participants|||Count of Participants
2824175|NCT00352053|Secondary|Change From Baseline to Week 240 in HIV-1 RNA||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
2815889|NCT00412360|Secondary|Percentage of Participants With Relapse|Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation.|1 year post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
2815890|NCT00412360|Secondary|Number of Infections Per Participant||2 years post-randomization|Transplanted participants|||Participants|||Count of Participants
2815891|NCT00412360|Secondary|Percentage of Participants With Chronic GVHD|Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event.|1 year post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
2815892|NCT00412360|Secondary|Percentage of Participants With Acute Graft-versus-host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 post-randomization|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
2815893|NCT00412360|Secondary|Time to Neutrophil and Platelet Engraftment|Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.|2 years post-transplant|Transplanted participants|||days||Full Range|Median
2815894|NCT00412360|Secondary|Percentage of Participants With Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.|Days 42 and 100|Transplanted participants|||percentage of participants||95% Confidence Interval|Number
2815895|NCT00412360|Secondary|Percentage of Participants With Disease-free Survival|Disease-free survival is defined as survival without relapse of the primary disease.|1 year post-randomization||||percentage of participants||95% Confidence Interval|Number
2815896|NCT00412360|Primary|Percentage of Participants With Overall Survival|Overall survival is defined as survival of death from any cause.|1 year post-randomization||||percentage of participants||95% Confidence Interval|Number
2815897|NCT00412243|Primary|Maximum Tolerated Dose for Cyclophosphamide (MTD)|MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle|First 14 days of each cycle|MTD calculated with first 8 study participants.|||mg/m^2|||Number
2815898|NCT00412217|Secondary|Overall Survival (OS)|OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.|||months||95% Confidence Interval|Median
2815899|NCT00412217|Secondary|Number of Participants Who Died|The number of participants who died from any cause was reported.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.|||participants|||Number
2815900|NCT00412217|Primary|Time to Progression (TTP)|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)|ITT Population.|||months||95% Confidence Interval|Median
2815901|NCT00412217|Primary|Number of Participants With Disease Progression|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.|From inclusion in the study until disease progression (maximum up to 3 years overall)|ITT Population.|||participants|||Number
2815902|NCT00412113|Primary|Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk|Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.|Week 6, baseline|The full analysis set of all randomized subjects who took at least one dose of study drug and had any post-baseline efficacy assessment|||score on scale||Standard Deviation|Least Squares Mean
2815903|NCT00412113|Secondary|Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.|Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||score on scale||Standard Deviation|Least Squares Mean
2815904|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) at Week 6.|Mean change at observation minus mean baseline.|Week 6 , baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
2815905|NCT00412113|Secondary|Change From Baseline in Total Cholesterol (TC) to Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mg/dL||Standard Deviation|Mean
2815906|NCT00412113|Secondary|Change From Baseline in HDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
2815907|NCT00412113|Secondary|Change From Baseline in LDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
2815908|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) to Week 4.|Mean change at observation minus baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
2815909|NCT00412113|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mg/dL||Standard Deviation|Mean
2815910|NCT00412113|Secondary|Change From Baseline in High Density Lipoprotein (HDL) at Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mg/dL||Standard Deviation|Mean
2815911|NCT00412113|Secondary|Change From Baseline in LDL at Week 4.|Change: mean of observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mg/dL||Standard Deviation|Mean
2815912|NCT00412113|Secondary|Change From Baseline to Week 6 in Pulse Rate|Mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||bpm||Standard Deviation|Mean
2815913|NCT00412113|Secondary|Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)|Change from mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mmHg||Standard Deviation|Median
2815914|NCT00412113|Secondary|Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)|Mean change at observation minus mean baseline.|Week 6, baseline|Full analysis set: all randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||mmHg||Standard Deviation|Mean
2815915|NCT00412113|Secondary|Change From Baseline to Week 4 in Pulse Rate|Mean at observation minus mean at baseline measured in beats per minute (bpm).|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||bpm||Standard Deviation|Mean
2815916|NCT00412113|Secondary|Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mmHg||Standard Deviation|Mean
2815917|NCT00412113|Secondary|Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||mmHg||Standard Deviation|Mean
2815918|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 6|Subjects achieving BP goal of <140/90 mmHg at week 6|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||participants|||Number
2815919|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 4|Subjects achieving BP goal of <140/90 mmHg at week 4|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS|||participants|||Number
2815920|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 6|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.|||participants|||Number
2815921|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 4|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||participants|||Number
2815922|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.|Week 6|Full analysis set (FAS).|||participants|||Number
2815923|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||participants|||Number
2815924|NCT00412113|Secondary|Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4|Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.|Week 4|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.|||participants|||Number
2815925|NCT00412113|Primary|Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6|Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)|Week 6|Full analysis set (FAS) is all randomized subjects who take at least one dose of study drug and and have any post-baseline efficacy assessments.|||participants|||Number
2815926|NCT00412087|Secondary|Parathyroid Hormone at Visit 7|Intact parathyroid hormone at Visit 7, one month prior to delivery|7 months|There was 1 subject in the 2000 IU group and 3 subjects in the 4000 IU group missing PTH measurements.|||pg/mL||Standard Deviation|Mean
2815927|NCT00412087|Primary|25-hydroxyvitamin D at Visit 7|25-hydroxyvitamin D at Visit 7, one month prior to delivery|7 months||||ng/mL||Standard Deviation|Mean
2815928|NCT00412074|Secondary|Infant Health Status - Vitamin D Deficiency|Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months of age|The number of infants analyzed in each group was fewer than the number of subjects analyzed for the maternal outcomes - though blood draws were attempted for all infants at Visit 7, we were unable to obtain blood from 14 infants in the 400 IU arm, 7 infants in the 2400 IU arm, and 14 infants in the 6400 IU arm.|||percentage of infants|||Number
2815929|NCT00412074|Secondary|Maternal Health Status - Vitamin D Deficiency|Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months postpartum||||percentage of participants|||Number
2815930|NCT00412074|Primary|25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery||to 7 months postpartum||||ng/mL||Standard Deviation|Mean
2815931|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)|"Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as Non-elevated."|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.|||Months||95% Confidence Interval|Median
2815932|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.|||Patients|||Number
2815933|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.|||Patients|||Number
2815934|NCT00412061|Secondary|Overall Survival Using Kaplan-Meier Methodology|Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.|Months 12, 24, 36, 48|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
2815935|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level|5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.|||Months||95% Confidence Interval|Median
2815936|NCT00412061|Secondary|Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)|The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.|||Percentage of patients||95% Confidence Interval|Number
2815937|NCT00412061|Primary|Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review|Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2815938|NCT00411788|Secondary|To Evaluate the Use of FDG-PET as an Early Predictor of Response to the Combination of Rapamycin and Trastuzumab, be Assessing Changes in Glucose Metabolism and Cell Viability Between Pre- and Post-treatment||Upon completion of study|This outcome measure was not collected nor analyzed due to study closure and low sample size.||||||
2815939|NCT00411788|Secondary|To Determine if Currently Available RNA Expression Profiles Associated With Response to Herceptin Will be Predictably Altered in Tumors Treated With Trastuzumab and Rapamycin, and Will Further Elucidate the Mechanism of Synergy of These Two Agents||study completion|This outcome measure was not collected nor analyzed due to study closure and low sample size.||||||
2815940|NCT00411788|Secondary|To Determine Pre and Post Therapy Changes in the Levels, Phosphorylation Status and/or Subcellular Localization of the Affected Signal Transduction Molecules HER2, Akt, S6K and 4EBP1 in Blood and Tumor Tissues|These data were not collected and analyzed as described here in the initial protocol submission.|Upon completion of study|||||||
2815941|NCT00411788|Secondary|Incidence of Cardiac Dysfunction|"This safety measure was used to determine the number of patients treated with the combination of trastuzumab and rapamycin with cardiac dysfunction.~This secondary outcome measure was reworded from its original version when results were entered."|study completion up to 58 weeks|Safety population consisting of 9 of 11 patients that received treatment following first dose.|||participants|||Number
2815942|NCT00411788|Secondary|Objective Response Rate (ORR)|"ORR was determined according to RECIST criteria, duration of response, and time to progression in patients with HER2 overexpressing advanced breast cancer receiving trastuzumab and rapamycin. The objective response rate (ORR) by response evaluation criteria (RECIST) 1.0, duration of response, safety, and pharmacodynamic endpoints.~This secondary outcome measure was reworded from its original submission when results were entered."|study completion up to 58 weeks||||participants|||Number
2815943|NCT00411788|Primary|Proportion of Patients Who Are Progression-free (CR, PR and Stable Disease)|"To determine the clinical activity of oral daily rapamycin administered in combination with weekly intravenous trastuzumab in patients with HER2 overexpressing advanced breast cancer, the primary outcome is to determine the proportion of patients who are progression-free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD).who are progression free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD). Response objectives assessed using response evaluation criteria (RECIST) 1.0~This primary outcome was reworded from its original format when results were entered."|16 weeks|Nine patients were evaluable for response assessment. Two patients withdrew from study before first response assessment (one for noncompliance and the other for toxicity).|||participants|||Number
2815944|NCT00411762|Secondary|Median Overall Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response|||weeks||Full Range|Median
2815945|NCT00411762|Primary|Median Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response|||weeks||Full Range|Median
2815946|NCT00411749|Secondary|HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series|Month 30 HPV cLIA Geometric Mean Titers by vaccine group.|24 month after completed vaccination series (Month 30)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
2815947|NCT00411749|Primary|Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
2815948|NCT00411749|Primary|Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
2815949|NCT00411749|Primary|Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
2815950|NCT00411749|Primary|Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group.~The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.|||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
2815951|NCT00411671|Secondary|Tumor Response Measured Every 8-weeks|Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|At baseline and then every 8 weeks until treatment discontinuation.|Of the enrolled participants, only 98 were evaluable for the outcome.|||participants|||Number
2815952|NCT00411671|Secondary|Progression-Free Survival|The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.|From date of randomization until PD or death respectively, up to 3 years|Of the enrolled participants, only 98 were evaluable for the outcome.|||months||Full Range|Median
2815953|NCT00411671|Primary|8-Week Disease Control Rate|The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 8 weeks|Of the enrolled participants, 98 were evaluable for the outcome.|||percentage of participants|||Number
2815954|NCT00411645|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of VP 44469, a metabolite of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The PK population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
2815955|NCT00411645|Secondary|Plasma Concentration of Maribavir During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The pharmacokinetic (PK) population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.|||μg/mL||Standard Deviation|Mean
2815956|NCT00411645|Secondary|Number of Participants Who Died Within 12 Months Post-Transplantation||Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.|||participants|||Number
2815957|NCT00411645|Secondary|Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)|Analysis of chronic GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for chronic GVHD. The percentage reported is for the occurrence of any grade of chronic GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.|||percentage of participants|||Number
2815958|NCT00411645|Secondary|Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)|Analysis of acute GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for acute GVHD. The percentage reported is for the occurrence of any grade of acute GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT Safety (ITT-S) population, defined as participants in the ITT population who received at least one dose of study drug.|||percentage of participants|||Number
2815959|NCT00411645|Secondary|Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|12 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
2824176|NCT00352053|Secondary|Change From Baseline to Week 192 in HIV-1 RNA||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
2815960|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
2815961|NCT00411645|Secondary|Number of Participants With Investigator-determined CMV Disease|CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
2815962|NCT00411645|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay or (2) CMV DNA polymerase chain reaction (PCR). CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||days||Inter-Quartile Range|Median
2815963|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
2815964|NCT00411645|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The Intent-to-Treat (ITT) population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.|||participants|||Number
2815979|NCT00411450|Primary|Time to Treatment Failure|Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
2816773|NCT00406393|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.|Measured at Day 21||||units on a scale||Standard Deviation|Mean
2815965|NCT00411632|Primary|Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type|The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen. A radiologist independently assessed DC, which was defined as a complete or partial response or stable disease according to the RECIST(29) at the end of 8 weeks (start of treatment to end of second treatment cycle). PFS was assessed from the date of randomization to the earliest sign of disease progression or death from any cause. OS was assessed from the date of randomization until death from any cause. Tumor response was assessed every 8 weeks until disease progression. Toxicity was assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.|8 weeks|The primary end point was the 8-week DCR [complete or partial response or stable disease via Response Evaluation Criteria in Solid Tumors (RECIST, which we compared with the historical 30% DCR estimate in similar patients. Treatment efficacy (a positive finding) was defined as >0.80 probability of achieving>30% DCR.|||participants|||Number
2815966|NCT00411619|Secondary|Overall Reduction in SEGA Tumor Volume.||During the entire study||||participants|||Number
2815967|NCT00411619|Primary|Number With Observed Adverse Side Effects||During the entire study||||participants|||Number
2815968|NCT00411554|Secondary|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
2815969|NCT00411554|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
2815970|NCT00411554|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.|||Percent||95% Confidence Interval|Least Squares Mean
2815971|NCT00411463|Secondary|Number of Participants With a Response|Number of participants with response defined as an average of 50% (or greater) reduction in the subject's baseline HRSD-25 score over three consecutive weeks and a current YMRS score ≤ 10|Week 12||||Participants|||Count of Participants
2815972|NCT00411463|Secondary|Descriptive Measures of the Feasibility of IPSRT-BPII|Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility.|Week 12||||Participants|||Count of Participants
2815973|NCT00411463|Secondary|Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)|The total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.|Baseline and Week 12||||scores on Q-LES-Q scale||95% Confidence Interval|Least Squares Mean
2815974|NCT00411463|Primary|Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10|Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome.|Week 12||||participants|||Number
2815975|NCT00411450|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.|Prior to first dose and 28 days after the last dose of second-line treatment|Safety Analysis Set with baseline anti-panitumumab antibody testing sample available|||participants|||Number
2815976|NCT00411450|Secondary|Number of Participants With Grade 4 Laboratory Toxicities|Laboratory toxicities were graded according to CTCAE version 3.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety Analysis Set|||participants|||Number
2815977|NCT00411450|Primary|Time to Response|Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders in the Tumor Response Analysis Set|||weeks||Full Range|Median
2815978|NCT00411450|Primary|Time to Progression|Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
2815980|NCT00411450|Primary|Overall Survival|Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
2815981|NCT00411450|Primary|Duration of Response|Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders of Tumor Response Analysis Set|||weeks||95% Confidence Interval|Median
2815982|NCT00411450|Primary|Disease Control Rate at Weeks 17 and 25|The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.|Week 17 and Week 25|Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
2815983|NCT00411450|Primary|Progression-free Survival Time|Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set|||weeks||95% Confidence Interval|Median
2815984|NCT00411450|Primary|Progression-free Survival Rate at Weeks 17 and 25|"The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria.~PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment."|Week 17 and Week 25|Primary Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, and who had valid KRAS mutation status data available)|||percent probability||95% Confidence Interval|Number
2815985|NCT00411450|Primary|Best Response During Second-Line Treatment|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders.~CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions."|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Tumor Response Analysis Set|||percentage of participants||95% Confidence Interval|Number
2815986|NCT00411450|Secondary|Number of Participants With Adverse Events|The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety analysis set (all participants who provided informed consent prior to the initiation of any study specific procedure and who received at least 1 dose of panitumumab)|||participants|||Number
2815987|NCT00411450|Primary|Objective Response Rate at Weeks 17 and 25|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|Week 17 and Week 25|Tumor Response Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, who had valid KRAS mutation status data available and with at least 1 uni-dimensionally measurable lesion per the local investigator)|||percentage of participants||95% Confidence Interval|Number
2824177|NCT00352053|Secondary|Change From Baseline to Week 144 in HIV-1 RNA||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
2815988|NCT00411411|Secondary|Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)|Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment|12 weeks|||||||
2815989|NCT00411411|Primary|Restoration of the Insulinotropic Effect of GIP|Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.|12 weeks||||pM x 120 min||Standard Error|Mean
2815990|NCT00411411|Primary|the Relative Increase in Meal-induced Total GLP-1 Secretion|Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).|12 weeks||||pM x 120 min||Standard Deviation|Mean
2815991|NCT00411398|Primary|Hamilton Anxiety Scale|Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety|10 wk|LOCF if at least one post baseline visit completed|||units on a scale||Standard Deviation|Mean
2815992|NCT00411216|Secondary|Eye Movements: Scleral Search Coil|eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field|pre- and post-treatment|||||||
2815993|NCT00411216|Secondary|Fall Risk (Dynamic Gait Index)|performance test|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
2815994|NCT00411216|Secondary|Balance and Gait|gait speed|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
2815995|NCT00411216|Secondary|Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium|visual analoque scales|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
2815996|NCT00411216|Secondary|Activities Specific Balance Confidence Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
2815997|NCT00411216|Secondary|Disability Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
2815998|NCT00411216|Primary|Subjective Complaints: (All Pre- and Post-intervention):|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
2815999|NCT00411216|Primary|Change in Visual Acuity During Head Movement From Baseline to Discharge|"visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.~The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention)."|pre-intervention and at discharge||||LogMAR||Standard Deviation|Mean
2816000|NCT00411151|Secondary|Safety and Tolerability: Adverse Events in ≥10% of Patients||one year|Safety population comprises all patients registered.|||Participants|||Number
2816001|NCT00411151|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|one year|Safety population comprises all patients registered.|||Participants|||Number
2816002|NCT00411151|Secondary|Adverse Events|The number of participants with at least one adverse event was measured.|one year|Safety population comprises all patients registered.|||Participants|||Number
2816003|NCT00411151|Secondary|One-Year Survival|One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Participants (%)||95% Confidence Interval|Number
2816004|NCT00411151|Secondary|Overall Survival (OS)|OS is defined as the time from the first dose of trial medication to date of death due to any cause.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Days||95% Confidence Interval|Median
2816005|NCT00411151|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose of trial medication to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Days||95% Confidence Interval|Median
2816006|NCT00411151|Primary|Objective Response Rate (ORR)|The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.|||Participants (%)||95% Confidence Interval|Number
2816007|NCT00411086|Secondary|Overall Response (OR) Rate|OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment.|3 Months||||percentage of participants|||Number
2816008|NCT00411086|Secondary|Median Progression-Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS.|3 years||||Months||95% Confidence Interval|Median
2816009|NCT00411086|Primary|Complete Response Rate|"Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities [e.g., lactate dehydrogenase (LDH)] definitely assignable to NHL.~Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas."|12 weeks (3 months)|Response includes unconfirmed CRs.|||percentage of participants|||Number
2816010|NCT00410904|Secondary|Overall Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.|The time from start of treatment to time of death, assessed up to 4 years||||months||95% Confidence Interval|Median
2816011|NCT00410904|Secondary|Progression-free Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|The duration of time from start of treatment to time of progression, assessed up to 4 years||||months||95% Confidence Interval|Median
2816012|NCT00410904|Primary|Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT:~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)"|Up to 4 years||||participants|||Number
2816013|NCT00410891|Primary|Positive Culture|The percentage of patients with a positive bacterial culture following administration of study treatment is presented.|Study day 1, assessed following administration of study treatment||||percentage of patients|||Number
2816014|NCT00410826|Secondary|Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 3 months for up to 5 years||||participants|||Number
2816015|NCT00410826|Secondary|Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm||30 days after the completion of therapy|||||||
2816016|NCT00410826|Primary|Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm|Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).|12 weeks after the completion of therapy||||percentage of participants|||Number
2816017|NCT00410813|Secondary|Mean Patient-reported Pain|"Patient's rating of worst pain experienced between prestudy and week 24. Changes of >=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning."|Baseline, 8, 16, and 24 weeks|All patients with non-missing values were analyzed|||units on a scale||Standard Deviation|Mean
2816018|NCT00410813|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 2 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2816019|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- TRAP|Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||U/L||Standard Deviation|Mean
2816020|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- OPG|Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||pmol/L||Standard Deviation|Mean
2816021|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- OC|Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||ng/mL||Standard Deviation|Mean
2816022|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time|Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||pg/mL||Standard Deviation|Mean
2816023|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- BAP|Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||ug/L||Standard Deviation|Mean
2816024|NCT00410813|Secondary|Change in Serum Bone Turnover Markers Over Time -- NTx|Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.|at baseline, 4, and 8 weeks|Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.|||nM BCE||Standard Deviation|Mean
2816025|NCT00410813|Secondary|Circulating Tumor Cells (CTC) Response Rate|CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (>= 5 cells/7.5 ml), whose CTC level drops to < 5.|Up to 4 weeks|Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline.|||participants|||Number
2816026|NCT00410813|Secondary|MUC-1 Antigen Response|MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 <= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.|at 4, 8, 16, and 24 weeks|MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints.||||||
2824178|NCT00352053|Secondary|Change From Baseline to Week 96 in HIV-1 RNA||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||log10 copies/mL||Inter-Quartile Range|Median
2816027|NCT00410813|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|All eligible patients|||participants|||Number
2816028|NCT00410813|Primary|Progression-free Survival|RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.|Up to 2 years|All eligible patients were included in this analysis.|||weeks||95% Confidence Interval|Median
2816029|NCT00410761|Secondary|Time to Worsening of Pain (TWP)|TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.|During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.||||Weeks|||Number
2816030|NCT00410761|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.|Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up||||Participants|||Number
2816031|NCT00410761|Secondary|Biochemical Response Calcitonin (CTN)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.|Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up||||Participants|||Number
2816032|NCT00410761|Secondary|Overall Survival (OS)|As data was immature at data cut off, number of death events is quoted|Number of deaths since randomisation||||Participants|||Number
2816033|NCT00410761|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent|DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median|||Months||95% Confidence Interval|Median
2816034|NCT00410761|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent||||Participants|||Number
2816035|NCT00410761|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.||||Participants|||Number
2816036|NCT00410761|Primary|Progression-Free Survival(PFS)|Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.||||Months||95% Confidence Interval|Median
2816037|NCT00410605|Secondary|Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at 3 Months Post-baseline|A Wilconxon signed-rank test conducted to determine if biomarker levels differed between baseline levels and those after three full cycles of treatment for all patients.|Up to Course 4 Day 1 (3 Months Post-baseline)||||mg per liter||Standard Deviation|Mean
2816038|NCT00410605|Secondary|Local Cytokine Milieu Using Tissue Micro Arrays of Bone Marrow Biopsy Specimens||Up to 5 years|Outcome measure data were not collected.||||||
2816039|NCT00410605|Secondary|Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at Baseline|A Wilconxon signed-rank test conducted to determine if biomarker levels differed between baseline levels and those after three full cycles of treatment for all patients.|Baseline||||mg per liter||Standard Deviation|Mean
2816040|NCT00410605|Secondary|Toxicity and Tolerability of the Bevacizumab and Lenalidomide Combination|Adverse events/toxicities were collected during regular clinical visits. Confidence intervals for the estimate of the true number of patients suffereing from grade 3 or 4 toxicities per common terminology criteria were calculated using the Wilson interval. Ninety-five percent confidence intervals for the proportions of patients with complications (grade 3 or higher toxicities) were constructed.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2816041|NCT00410605|Primary|Progression Free Survival (Time to Progression)|Patient response to the treatment were determined by the definitions for complete response, partial response, marginal response, stable disease, and progressive disease outlined by IMBTR/ABMTR (Blade criteria). Progression free survival was summarized using point estimates of the median time to progression and associated 95% confidence intervals. The data was presented graphically using Kaplan-Meier plots. Exploratory analysis, including multivariate Cox regression with demographic variables and markers of myeloma activity as covariates was performed.|up to five years||||months||95% Confidence Interval|Median
2816042|NCT00410605|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide|Patient response to the treatment were determined by the definitions for complete response, partial response, marginal response, stable disease, and progressive disease outlined by IMBTR/ABMTR (Blade criteria). Responses were analyzed by descriptive statistics and summarized in tabular format (frequency tables). Furthermore, two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response were computed using the method proposed by Chang, which takes into account the multiplicity problem associated with the two-stage testing procedure. The objective response rate was estimated by using Whitehead's bias-adjustment approach.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2816043|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816044|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816045|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816046|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816047|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||mL||Standard Error|Least Squares Mean
2816139|NCT00410280|Secondary|Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35|The collected sputum was planned to be analyzed for epithelial cells, eosinophils, lymphocytes, neutrophils, metachromatic cells, or macrophages counts. Sputum induction was to be performed after each methacholine challenge and at 7 hours after each allergen inhalation challenge.|Baseline, Day 14, 35|Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||||||
2816048|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. The analysis only includes patients with >0 incontinence episodes at baseline. End of treatment (EOT) includes patients who didn't complete Week 12.|||Incontinence episodes||Standard Error|Least Squares Mean
2816049|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours|"For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||Urgency episodes||Standard Error|Least Squares Mean
2816050|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||micturitions||Standard Error|Least Squares Mean
2816051|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816052|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score|"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816053|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816054|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score|"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.|||scores on a scale||Standard Error|Least Squares Mean
2816055|NCT00410514|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|The Safety Analysis set included all participants who received at least one dose of study drug.|||participants|||Number
2816056|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)|"Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Safety Analysis set included all participants who received at least one dose of study drug. End of treatment (EOT) analysis includes the last assessment for patients who did not complete the Week 12 visit; N indicates the number of patients included at each time point.|||mL||Standard Error|Least Squares Mean
2816057|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)|"Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||Percent voiding efficiency||Standard Error|Least Squares Mean
2816058|NCT00410514|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||cmH2O||Standard Error|Least Squares Mean
2816059|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)|"The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||Scores on a scale||Standard Error|Least Squares Mean
2816060|NCT00410514|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|"Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.|||mL/sec||Standard Error|Least Squares Mean
2816061|NCT00410488|Primary|Palonosetron Response Rate in the 10 Day Study Cycle|Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.|10 days||||percentage of participants|||Number
2816062|NCT00410423|Primary|Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.~The percentage of participants that experienced complete response will be reported."|Up to 7 years||||percentage of participants|||Number
2816063|NCT00410423|Primary|Number of Participants With Dose Limiting Toxicity in Phase I|Dose limiting toxicity (DLT) is defined as grade-3 toxicity definitely related to bortezomib or grade-4 toxicity probably or definitely related to bortezomib.|30-90 days||||Participants|||Count of Participants
2816064|NCT00410410|Secondary|OL; Number of Participants Using Corticosteroids During OL|Participants taking oral corticosteroids (equivalent of ≤ 30 mg prednisone daily) must have met minimum treatment duration at entry into IP and had stable dose for ≥2 weeks prior to entry into the IP.|Day OL-1 through Day OL-729|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of corticosteroid use was not conducted for the OL as planned.||||||
2816158|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816065|NCT00410410|Secondary|OL; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."|||participants|||Number
2816066|NCT00410410|Secondary|OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Clinical remission = Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Change from Baseline= post-Baseline - Baseline value.|Last Study Visit (Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical efficacy upon retreatment with abatacept among participants who received study drug during the IP or MP was not conducted for the OL as planned.||||||
2816067|NCT00410410|Secondary|OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Open-Label Period (Day OL-1 through Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing was not conducted for the OL as planned.|||participants|||Number
2816068|NCT00410410|Primary|OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816069|NCT00410410|Primary|OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816070|NCT00410410|Primary|OL; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816071|NCT00410410|Secondary|OL; Number of Participants With Clinical Remission Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.|||participants|||Number
2816072|NCT00410410|Secondary|OL; Number of Participants With Clinical Response Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.|||participants|||Number
2816159|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2825030|NCT00344461|Secondary|Change in Plasma HIV RNA From Baseline to Week 96|Percent Change From Baseline in Plasma HIV RNA at 96 weeks|Baseline to week 96||||percentage of change||Standard Deviation|Mean
2816073|NCT00410410|Primary|OL; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day OL-1 through Day OL-729|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.||||||
2816074|NCT00410410|Secondary|MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816075|NCT00410410|Secondary|MP; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than ULN, Low=lower than LLN. LLN/ULN= HGB: >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; PLT: <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; GGT: >2 x ULN; Bilirubin: >2 x ULN; BUN: >2 x BL; Na: <0.95 x LLN/ >1.05 x ULN; K: <0.9 x LLN/ >1.1 x ULN; Ca: <0.8 x LLN/>1.2 x ULN|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816076|NCT00410410|Secondary|MP; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-85 through Day MP-365|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.||||||
2816077|NCT00410410|Secondary|MP; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816078|NCT00410410|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816079|NCT00410410|Secondary|MP; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1).|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."|||participants|||Number
2816080|NCT00410410|Secondary|MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||||||
2816173|NCT00410189|Secondary|8 Week Progression-Free Survival|Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.|Every 8 weeks till disease progression.||||months||Full Range|Median
2816081|NCT00410410|Secondary|MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical remission in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||||||
2816082|NCT00410410|Secondary|MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical response in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||||||
2816083|NCT00410410|Secondary|MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with PGA subscores indicating mild disease (≤1) was not conducted for the MP as planned.||||||
2816084|NCT00410410|Secondary|MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with stool frequency subscores indicating mild disease (≤1) was not conducted for the MP as planned.||||||
2816085|NCT00410410|Secondary|MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with rectal subscores indicating mild disease (≤1) was not conducted for the MP as planned.||||||
2816086|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.||||||
2816087|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36)|The SF-36 is a validated instrument to measure health-related quality of life across multiple disease states. Individual subscale scores and 2 summary scores are calculated: (1) physical component summary (PCS) which includes physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS) which includes vitality, social functioning, role-emotional, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight, with values ranging from worse health (0) to best health (100).|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.||||||
2816088|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in IBDQ|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.||||||
2816878|NCT00405912|Secondary|Number of Subjects With Prolonged Abstinence From Tobacco|tobacco abstience during the 12-week course of SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day compared to placebo at six months.|24 weeks after the start of medication||||participants|||Number
2816089|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.||||||
2816090|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 6 (Day MP-169), Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants in clinical remission at both Month 6 and Month 12 was not conducted for the MP as planned.||||||
2816091|NCT00410410|Secondary|MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816092|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816093|NCT00410410|Secondary|IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."|||participants|||Number
2816094|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816095|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN;|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816096|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816097|NCT00410410|Secondary|IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816098|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816099|NCT00410410|Secondary|IP; Number of Participants With Physical Examination Findings: IP1C + IP2C|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-1 through Day IP-85|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.||||||
2816100|NCT00410410|Secondary|IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816101|NCT00410410|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||participants|||Number
2816102|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
2816103|NCT00410410|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.|||participants|||Number
2816104|NCT00410410|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day OL-1 through the end of the OL|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.|||participants|||Number
2816105|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|"The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance~=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks."|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
2816839|NCT00406133|Secondary|Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||Mean mg/dl/minute||Standard Deviation|Mean
2816106|NCT00410410|Primary|Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816107|NCT00410410|Secondary|IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
2816108|NCT00410410|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.|||participants|||Number
2816109|NCT00410410|Secondary|IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816110|NCT00410410|Secondary|IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816111|NCT00410410|Secondary|IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816112|NCT00410410|Secondary|IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline (Day IP-1), Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||units on a scale||Standard Error|Mean
2816113|NCT00410410|Secondary|IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||units on a scale||Standard Deviation|Mean
2816380|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
2816114|NCT00410410|Secondary|IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816115|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816116|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816117|NCT00410410|Secondary|IP; Baseline Mayo Score: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.|||units on a scale||Standard Deviation|Mean
2816118|NCT00410410|Primary|Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants who were randomized and received at least one infusion of study medication (Intent To Treat Population, ITT) were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.|||participants|||Number
2816119|NCT00410384|Other Pre-specified|Adverse Event (AE) Overview|SEE ALSO ADVERSE EVENT RESULTS SECTION|Up to 80 Weeks||||Percentage of participants|||Number
2816120|NCT00410384|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40-52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day.|||Percentage of participants|||Number
2816121|NCT00410384|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a scale||Standard Error|Mean
2816122|NCT00410384|Secondary|Mean Change in Physician's Global Assessment (PGA) at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Scores on a 3-point scale||Standard Error|Mean
2816123|NCT00410384|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.||Baseline, 52 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.|||Percentage of participants|||Number
2816124|NCT00410384|Secondary|SRI Response Rate at Week 76|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 76 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 76 data.|||Percentage of participants|||Number
2816879|NCT00405821|Secondary|Virologic and Immunologic Responses to ART in Those Who Progress to CD+4 Less Than 250cells/mL||6 months and 12 moths post ART initiation|||||||
2816125|NCT00410384|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 Weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.|||Percentage of participants|||Number
2816126|NCT00410280|Secondary|Number of Participants With Antibodies to IMA-638||Baseline up to Day 168|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||participants|||Number
2816127|NCT00410280|Secondary|Serum Decay Half-Life (t1/2) for IMA-638|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||days||Standard Deviation|Mean
2816128|NCT00410280|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||mcg*hr/mL||Standard Deviation|Mean
2816129|NCT00410280|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638|Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
2816130|NCT00410280|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||days||Standard Deviation|Mean
2816131|NCT00410280|Secondary|Maximum Observed Serum Concentration (Cmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.|||microgram/milliliter(mcg/mL)||Standard Deviation|Mean
2816132|NCT00410280|Secondary|Protein Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure w as not analyzed because the study w as stopped early after interim analysis and only safety and key efficacy analyses w ere performed.||||||
2816133|NCT00410280|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||||||
2816134|NCT00410280|Secondary|Blood Levels of Interleukin-13 (IL-13)||Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||||||
2816135|NCT00410280|Secondary|Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34).|Baseline, Day 8, 13, 21, 34, 56, 84, 168|"ITT population included all randomized participants who received at least 1 dose administration of the test article. Here, n signifies participants evaluated for this measure at the specified time point for each arm."|||10^9 cells/Liter||Standard Error|Mean
2816136|NCT00410280|Secondary|Total Blood Eosinophil Counts at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on day 13 and 34).|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||10^9 cells/Liter||Standard Deviation|Mean
2816137|NCT00410280|Secondary|Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34). Results are reported for total IgE count.|Baseline, Day 13, 34, 56, 112, 168|"ITT population. Here, n signifies participants evaluated for this measure at the specified time point for each arm. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed."|||kU/L||Standard Error|Mean
2816138|NCT00410280|Secondary|Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge within a given challenge triad (planned on day 13 and 34). The challenge triad included pre-allergen methacholine inhalation challenge, allergen inhalation challenge, and post-allergen methacholine inhalation challenge. Results are reported for total IgE count.|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||kilo unit/liter (kU/L)||Standard Deviation|Mean
2816880|NCT00405821|Secondary|Adherence to Acyclovir||2 years|||||||
2816881|NCT00405821|Secondary|Toxicity of Acyclovir||2 years|||||||
2816140|NCT00410280|Secondary|Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge|Methacholine inhalation test was performed to determine airway hyper-reactivity using provocative concentration 20 (PC20). PC20 was the lowest concentration of methacholine at which participant had 20% decrease from baseline in FEV1. Pre-allergen challenge methacholine inhalation test was performed 1 day prior to the allergen challenge and post-allergen challenge methacholine inhalation test was performed 1 day after to the allergen challenge (that is, pre- and post-allergen methacholine inhalation test was conducted on Day -15 and -13 for Screening allergen challenge, Day 13 and 15 for Day 14 allergen challenge and Day 34 and 36 for Day 35 allergen challenge, respectively). For each methacholine inhalation test, baseline FEV1 was defined as the lowest value among the triplicate readings taken after administration of the diluent (saline administration). Difference between post-allergen challenge and pre-allergen challenge was expressed as log2 (post-allergen PC20 - pre-allergen PC20).|Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||Log2 milligram/milliliter (log2 mg/mL)||Standard Deviation|Mean
2816141|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 0 to 3 hours at each visit was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop*hour||Standard Deviation|Mean
2816142|NCT00410280|Secondary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 0 to 3 hours was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
2816143|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of >=15% at 3 to 7 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 3 to 7 hours was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||Percent drop*hour||Standard Deviation|Mean
2816144|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
2816145|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
2816146|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)|ITT population included all randomized participants who received at least 1 dose administration of the test article.|||percent drop||Standard Deviation|Mean
2816147|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Serum Chemistry|ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN|On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks|All treated participants. n = number of participants in the OF period.|||participants|||Number
2816148|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Hematology|Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|From start of study through Week 100 + 5 days|All treated participants.|||participants|||Number
2816149|NCT00410202|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death.|From start of study therapy through Week 100 + 5 days|All treated participants.|||participants|||Number
2816150|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 2|"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 2|Treated participants who were tested for resistance were analyzed, ie. They met the following selection criteria: 1) participants with HBV DNA ≥ 50 IU/mL at Week 96 or at the last on-treatment visit and 2) who developed VBT. n=participants|||percentage of participants|||Number
2816151|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 1|"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 1|Treated participants who were tested for resistance, ie. met the following selection criteria. 1) participants with HBV DNA ≥ 50 IU/mL at Week 48 or at the last on-treatment visit and 2) who developed VBT . n=participants|||percentage of participants|||Number
2816152|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816153|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816154|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816155|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816156|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816157|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816160|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1) were analyzed. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816161|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L.|Week 48|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1). Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816162|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 96|HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values were analyzed. n= participants with baseline and Week 96 values.|||participants||Standard Error|Mean
2816163|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction.|Baseline, Week 48|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values. n=participants with baseline and Week 48 values.|||log10 (IU/mL||Standard Error|Mean
2816164|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay.|Week 96|Participants who received at least 1 dose of study therapy were analyzed.|||percentage of participants|||Number
2816165|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay.|Week 48|Participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
2816166|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816167|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816168|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||Percentage of participants|||Number
2816169|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816170|NCT00410202|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||Percentage of participants|||Number
2816171|NCT00410202|Primary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.|||percentage of participants|||Number
2816172|NCT00410189|Primary|8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)|The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|Baseline to 8 Weeks||||percentage of participants|||Number
2816174|NCT00410163|Secondary|Number of Participants With Progression or Death|Disease progression is characterized by at least one of the following, per the Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia: a >=50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations 2 weeks apart (at least one node must be >=2 centimeters); or the appearance of new palpable lymph nodes; or a >=50% increase in liver and/or spleen size (measurement below the costal margin); or the appearance of palpable hepatomegaly or splenomegaly not previously present; or a >=50% increase in the numbers of circulating lymphocytes to at least 5.0 * 10^9/Liter; or transformation to a more aggressive histology (e.g., Richter's syndrome or prolymphocytic leukemia with >55% prolymphocytes). For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS|||Participants|||Number
2816175|NCT00410163|Secondary|Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||liters||Geometric Coefficient of Variation|Geometric Mean
2816176|NCT00410163|Secondary|CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2816177|NCT00410163|Secondary|t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
2816178|NCT00410163|Secondary|AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-672) is AUC from start of infusion to 672 hours after start of infusion; AUC(0-inf) is AUC from start of infusion extrapolated to infinity.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
2816179|NCT00410163|Secondary|Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). No drug is present before the first infusion; therefore, there are no Ctrough results for the first infusion.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2816180|NCT00410163|Secondary|Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD)|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells (CD5+CD19+) to determine if there was any MRD.|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to course 6 or Week 32)|FAS. Only participants with CR at Visit 34 were analyzed.|||participants|||Number
2816181|NCT00410163|Primary|Number of Participants (Par.) Who Were Classified as Responders and Non-responders|Par. were evaluated by an IRC in accordance with NCI-WG 1996 guideline. Responders: CR, Nodular Partial Remission (nPR, same as CR, but persistent bone marrow nodules), and Partial Remission (PR, >=50% decrease in lymphocytes from pretreatment baseline (BL) value, >=50% reduction in lymphadenopathy, >=50% reduction of liver/spleen and neutrophils >= 1.5*10^9/L or platelets >100*10^9/L or hemoglobin >11 g/dL (or 50% improvement over BL for neutrophils, platelets, hemoglobin); non-responders: Stable Disease (SD, did not achieve CR/PR, and no PD), Progressive Disease (PD), or Not Evaluable (NE).|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|FAS|||participants|||Number
2816182|NCT00410163|Secondary|Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4)|Blood samples were drawn from participants at Visits 1 and 9 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 9 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Week -2) and Visit 9 (Week 4)|FAS. Data were provided for the number of participants attending Visit 9. Participants withdrawn during the study were not analyzed.|||Percent change in complement levels||Full Range|Median
2816183|NCT00410163|Secondary|Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia)|Myelosuppression is one of the expected AEs for FC treatment and is defined as the decrease in the ability of the bone marrow to produce blood cells. The number of participants with myelosuppression was assessed from laboratory measurements with Grades 3(severe)-4 (life-threatening/disabling) (1, mild; 2, moderate; 5, death) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The CTCAE is issued by the National Cancer Institute (NCI) and is the standard classification used for the severity grading scale for AEs in cancer therapy clinical studies.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS|||participants|||Number
2817371|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Triglycerides||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2816184|NCT00410163|Secondary|Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 21, 35, and 39 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening, Visit -2), 21 (Week 12), 35 (Month 6), and 39 (Month 18)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||participants|||Number
2816185|NCT00410163|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS|||participants|||Number
2816186|NCT00410163|Secondary|Median Percent Change in CD5+CD19+ and CD5+CD20+ Cells in Peripheral Blood From Onset of Course 3 Throughout Follow-up (FU) Compared to Screening|Malignant B cells (CD5+CD19+ and CD5+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Screening (Visit 1, Week -2) = (value at indicated visits minus value at Visit 1 divided by value at Visit 1) * 100. Visits 33 and 34 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 15 (Wk 8), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in cells||Full Range|Median
2816187|NCT00410163|Secondary|Median Percent Change in Tumor Size From Baseline (Visit 2, Wk 0) at Visits 9, 21, 25, 29, 33, 34, 35, and 37|Tumor size was measured by physical examination of palpable abnormal lymph nodes. Percent change from Baseline (Visit 2, Week 0) = (value at indicated visits minus value at Visit 2 divided by value at Visit 2) * 100. Visits 33, 34, 35, 36, and 37 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 9 (Wk 4), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI), 35 (M 6 after start of LI), 36 (M 9 after start of LI), and 37 (M 12 after start of L|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in tumor size||Full Range|Median
2816188|NCT00410163|Secondary|Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death|Time to next anti-CLL (anti-lymphoma) therapy was defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab or death. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From time of randomization to first administration of next anti-CLL therapy other than ofatumumab or death, assessed over 5 years|FAS|||months||95% Confidence Interval|Median
2816189|NCT00410163|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS|||months||95% Confidence Interval|Median
2816190|NCT00410163|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed.|From time of initial response to disease progression or death, whichever came first, assessed over 2 years|FAS. Only those participants classified as responders were analyzed.|||months||95% Confidence Interval|Median
2816191|NCT00410163|Primary|Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion|"Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as complete responders. As per NCI-WG, CR requires all of the following criteria for a period of >=2 months: absence of lymphadenopathy (all lymph nodes <1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes <=4.0*10^9/liter (L), neutrophil leukocytes >=1.5*10^9/L, platelets >100*10^9/L, and hemoglobin >11 grams/deciliter."|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment|||participants|||Number
2816192|NCT00410150|Primary|Length of Stay|Time to discharge eligibility (hours)|Hospital discharge||||hours||Standard Error|Mean
2816193|NCT00410124|Secondary|Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||L/hour/m^2||Standard Deviation|Mean
2816194|NCT00410124|Secondary|Pharmacokinetics of RAD001: Apparent Systemic Clearance From Blood Following Extravascular Administration (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.Apparent oral clearance of RAD001 (CL/F) was calculated using AUC in a dosing interval of 24 hours (AUC0-24hours) value on Day 15 as: CL/F = dose/ AUC0-τ|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||L/hour||Standard Deviation|Mean
2816195|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time of the Last Quantifiable Concentration in a Dosing Interval - (Tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||hour||Full Range|Median
2816196|NCT00410124|Secondary|Pharmacokinetics of RAD001: Area Under Curve (AUC) in a Dosing Interval From Time-zero to Time of the Last Quantifiable Concentration. (AUC 0-tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||ng.h/mL||Standard Deviation|Mean
2816197|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time at Which C-Max Occurs (t-Max)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose of From Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||h||Full Range|Median
2816198|NCT00410124|Secondary|Pharmacokinetics of RAD001:Peak Concentration in a Dosing Interval (C-max); Pre-dose Concentration at 24-h Time Point in Dosing Interval (C-min) and Average Concentration in a Dosing Interval =(C-avg)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol. C-avg= Area under curve (AUC) in a dosing interval from time-zero to time of the last quantifiable concentration (AUC0-tlast)/ time of the last quantifiable concentration in a dosing interval (tlast)|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day1, Cycle 1 Day 15 and at pre-dose from Cycle 2(day1) and all subsequent treatment cycles up until data cut-off 28 Feb 2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.|||ng/mL||Standard Deviation|Mean
2816199|NCT00410124|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
2816200|NCT00410124|Secondary|Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.|"The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. 0= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen."|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
2816201|NCT00410124|Secondary|Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
2816381|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
2816202|NCT00410124|Secondary|Duration of Response in Patients Who Receive RAD001 Plus BSC Versus Placebo Plus BSC|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||months||95% Confidence Interval|Median
2816203|NCT00410124|Secondary|Best Overall Response Rate in Patients Who Receive RAD001 Plus BSC Versus Matching Placebo Plus BSC|The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
2816204|NCT00410124|Secondary|Overall Survival (OS) Assessed by the Monthly Overall Survival Assessments|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group|Assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death. (Data cutoff was 15Nov2009)|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2816205|NCT00410124|Primary|Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC|Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2816206|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir|Week 96|Participants with confirmed >= 1 log10 increase in HBV DNA from moving nadir|||Participants|||Number
2816207|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 48|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir|Week 48|Participants with confirmed >=1 log10 increase in HBV DNA from the on-treatment nadir|||Participants|||Number
2816208|NCT00410072|Secondary|Number of Participants With HBV Resistance at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 96|Participants who received study drug and with HBV DNA levels >=50 IU/mL.|||Participants|||Number
2816209|NCT00410072|Secondary|Number of Participants With HBV Resistance Through Week 48|ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 48|All participants who received study drug and with HBV DNA levels >=50 IU/mL|||Participants|||Number
2816210|NCT00410072|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 100 + 24-week follow-up|All treated participants.|||Participants|||Number
2816211|NCT00410072|Secondary|Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96|Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.|At Weeks 48 and 96|All treated participants.|||Percentage of participants|||Number
2816212|NCT00410072|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||Percentage of participants|||Number
2816382|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
2816213|NCT00410072|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96|HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||Percent of participants|||Number
2816214|NCT00410072|Secondary|Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.|At Weeks 48 and 96|Treated HBeAg-positive participants. A participant missing the efficacy assessments for a visit was considered a failure and was counted as evaluable.|||Percentage of participants|||Number
2816215|NCT00410072|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96|HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||Percentage of participants|||Number
2816216|NCT00410072|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96|ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and counted as evaluable.|||Percentage of participants|||Number
2816217|NCT00410072|Secondary|Mean Log 10 HBV DNA at Weeks 48 and 96|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load.|Baseline, Weeks 48 and 96|Evaluable participants at given time point. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||log10 copies/mL||Standard Error|Mean
2816218|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96|LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
2816219|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96|LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
2816220|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
2816221|NCT00410072|Primary|Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Week 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.|||Percentage of participants|||Number
2816222|NCT00410059|Primary|8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)|"Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A success or disease control to treatment is defined as a participant being progression free at 8 weeks after randomization."|Radiographic evaluation after cycle 2 (8 weeks of therapy)|One participant was not evaluable for outcome.|||Participants|||Count of Participants
2817372|NCT00401973|Primary|Change From Baseline to Endpoint in Weight||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement.|||kilograms||Standard Error|Least Squares Mean
2816223|NCT00410046|Secondary|Change From Baseline Haywood Quality of Life Score From Baseline to Week 38|Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.|Baseline and 38 weeks|All patients from United Kingdom sites who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug had at least 1 post-baseline assessment and completed 38 weeks.|||units on scale||Standard Deviation|Mean
2816224|NCT00410046|Secondary|Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug, had at least 1 post-baseline assessment, and completed 38 weeks.|||units on scale||Standard Deviation|Mean
2816225|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
2816226|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
2816227|NCT00410046|Primary|Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
2816228|NCT00410046|Primary|Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
2816229|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
2816230|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38|BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (AS) patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
2816231|NCT00410046|Secondary|Change in Total Back Pain Score From Baseline to Week 38|Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||units on scale||Standard Deviation|Mean
2816232|NCT00410046|Secondary|Change in Patient Global Assessment of Disease Activity From Baseline to Week 38|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment|||units on scale||Standard Deviation|Mean
2825031|NCT00344461|Secondary|Patients With Plasma HIV RNA < 400 Copies/mL|The number of participants with plasma HIV RNA < 400 copies/mL|96 weeks||||Participants|||Count of Participants
2816233|NCT00410046|Secondary|Number of Sick Days Per Patient During the 48 Weeks of Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Sick days per patient||Full Range|Mean
2816234|NCT00410046|Secondary|Number of Patients With Sick Leave During 48 Weeks Treatment|The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
2816235|NCT00410046|Secondary|Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into study 0881A3-405, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||# of times utilized per patient||Full Range|Mean
2816236|NCT00410046|Secondary|Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks of treatment.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.|||patients|||Number
2816237|NCT00409838|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.|||mm/h||Standard Error|Mean
2816238|NCT00409838|Secondary|Change From Baseline in Levels of C-reactive Protein (CRP)||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.|||mg/dL||Standard Error|Mean
2816239|NCT00409838|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission|LDAS is defined as a Disease Activity Score C-reactive protein (DAS28-CRP) level <=3.2. Remission is defined as a DAS28-CRP level <2.6.|At Days 169, 337, 729, 1149, and 1485|All participants who finished the Short-term period. n=Number of evaluable participants|||Percentage of participants||95% Confidence Interval|Number
2816240|NCT00409838|Secondary|Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores|The SDAI is the sum of 5 parameters: Tender joint (TJC) and swollen joint(SJC)counts, based on a 28-joint assessment; patient global (PtGA)and physician global assessments (PGA), assessed on 0-10 cm visual analog scale (VAS), on which higher scores=greater affection due to disease activity DA); and C-reactive protein level. SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low DA, >11 to 26=moderate DA, and >26=high DA. SJC is assessed at each visit, with no swelling=0, swelling=1. TJC is assessed through identification of joints painful under pressure or to passive motion at each visit, with no tenderness=0, tenderness=1. Higher score=greater affection due to DA. CDAI is sum of 4 parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score=0-76. CDAI <=2.8 indicates disease remission, >2.8 to 10=low DA, >10 to 22=moderate DA, and >22=high DA.|At Days 169 and 1569|All participants who received study drug and who were evaluable|||Units on a scale||95% Confidence Interval|Mean
2816241|NCT00409838|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission|EULAR defines LDAS as a disease activity score as measured by c-reactive protein (DAS28-CRP) ≤3.2 and remission as DAS28-CRP <2.6|At Days 169 and 1485|All participants who received study drug and who were evaluable|||Percentage of participants|||Number
2816242|NCT00409838|Secondary|Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries|The SF-36 is a 36-item questionnaire used to measure Quality of Life over 8 physically and emotionally based areas: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Answers to each question correspond to a precoded numeric value. An aggregate percentage score is reached for each of the 8 sections and is based on answers to questions. The mean average is worked out for each section. Scores range from 0% (lowest level of functioning) to 100% (highest level of functioning, with higher score indicated increasing levels of functioning.|At Day 1485|All participants who received study drug and who were evaluable|||Units on a scale||Standard Error|Mean
2816243|NCT00409838|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|Day 1485|All participants who received study drug and who were evaluable|||Units on a scale||Standard Error|Mean
2816244|NCT00409838|Secondary|Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI)|Improvement is measured by an improved response of at least 0.3 units from baseline on the HAQ-DI score. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|At Day 1485|All participants who received study drug and who were evaluable|||Percentage of participants|||Number
2817599|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2816245|NCT00409838|Secondary|Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time|The ACR 20, ACR50, and ACR70 are based on 20%, 50% and 70% improvement, respectively, (compared with baseline values) in tender and swollen joint counts and on 20%, 50% and 70%, respectively, improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|Days 15 through 1569|All participants who completed the ST period and received at least 1 infusion of abatacept during the LTE period. n=evaluable participants at that timepoint for that measure.|||Percentage of participants||95% Confidence Interval|Number
2816246|NCT00409838|Secondary|LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples|Positive antibody titers were identified by validated enzyme-linked immunosorbent assay results. On-treatment samples were obtained during the LTE period, and posttreatment samples were following the last infusion of study medication.|Days 169, at 6-month intervals on-treatment, and at Days 28, 56, and 85 after the last infusion of study medication in the LTE period|All participants who during the LTE period, received at least 1 infusion of abatacept and had at least 1 immunogenicity sample collected.|||Participants|||Number
2816247|NCT00409838|Primary|Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period|All participants who completed the short-term period and received at least 1 infusion of abatacept during the LTE period|||Participants|||Number
2816248|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169|Mean change in RF. A surrogate marker is an indirect measurement of effectiveness. Mean change from Baseline = postbaseline - baseline value.|Baseline, Day 169|All Randomized and Treated Participants. The summary was based on the last observation carried forward (LOCF) procedure. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.|||IU/mL||Standard Error|Mean
2816249|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169|Mean change in surrogate marker mean ESR. A surrogate marker is an indirect measurement of effectiveness. Change from Baseline = postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.|||mm/h||Standard Error|Mean
2816250|NCT00409838|Secondary|Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169|Immunogenicity was determined by measuring adult subject sera for reactivity against the whole Abatacept molecule (CTLA4Ig) and CTLA4-T (CTLA4 without the Ig regions).|Day 169|All participants who received study drug (abatacept)|||participants|||Number
2816251|NCT00409838|Secondary|Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept|Minimum concentration (Cmin) of Abatacept 500 mg and 750 mg at given time points|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85|Participants with measurement at timepoint|||μg/mL||Standard Deviation|Mean
2816252|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS)|The volume of distribution of drug at steady state (VSS). Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level|||L/kg||Standard Deviation|Mean
2816253|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Clearance is a pharmacokinetic parameter that describes how quickly drugs are eliminated, metabolized or distributed throughout the body.|Day 29, every 28 days until Day 141|Participants with measurement at stated dose level|||mL/h/kg||Standard Deviation|Mean
2816254|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC)|Area Under the Plasma Concentration-Time Curve (AUC), a measure of drug absorption, in a dosing interval of 28 days from Day 85 to Day 113. Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level|||μg.h/mL||Standard Deviation|Mean
2816255|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Maximum Concentration (Cmax)= the maximum plasma concentration of the drug.|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level|||μg/mL||Standard Deviation|Mean
2816256|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Tmax = the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. T-Half = the biological half-life or elimination half life of a substance is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.|At the end of infusion and 2 to 4 hours after the start of infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level|||Hours||Standard Deviation|Mean
2816383|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
2816257|NCT00409838|Secondary|Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout double-blind study period (up to Day 169); table includes data up to 56 days past double-blind period or start of the open-label period, whichever occurred first.|All randomized participants who received study drug.|||Percentage of participants|||Number
2816258|NCT00409838|Secondary|Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains|Adjusted mean change from baseline. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life and comprised of 8 domains( including 4 physical and 4 mental subscales) used to derive the physical and mental component summary scores. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Change from baseline=postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug and were evaluable.|||Units on a scale||Standard Error|Mean
2816259|NCT00409838|Secondary|Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|Adjusted mean change from baseline. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug|||Units on a scale||Standard Error|Mean
2816260|NCT00409838|Secondary|Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR])|Adjusted mean change from baseline. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). CRP or ESR give estimations of DAS28 values on a group level. Change from Baseline=Postbaseline - Baseline value.|From Baseline to Days 169 and 1485|All randomized participants who received study drug and who were evaluable.|||Units on a scale||Standard Error|Mean
2816261|NCT00409838|Secondary|Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components|The ACR defines improvement in core components as 20%, 50%, or 70% improvement in tender and swollen joint counts and 3 of the remaining core components: patient global assessment of disease activity, physician global assessment of disease activity, patient assessment of pain, patient self-assessed disability (Health Assessment Questionnaire Disability Index [HAQ-DI]), and levels of 1 acute phase reactant (C-reactive protein levels or erythrocyte sedimentation rate.) The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning; scale=0 (no disability) to 3 (completely disabled); total possible score=24. The higher the score, the greater the disability.|From Baseline to Day 169|All randomized participants who received study drug and who were evaluable.|||Percentage of participants|||Number
2816262|NCT00409838|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169|The ACR defines ACR 50 and ACR70 response as a 50% or 70% improvement (compared with baseline values) in tender and swollen joint counts and 50% or 70% improvement in 3 of the remaining 5 core set measures (patient global assessment of pain, patient global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and 1 acute phase reactant value (C-reactive protein).|At Day 169|All randomized participants who received study drug.|||Percentage of participants|||Number
2816263|NCT00409838|Primary|Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20)|The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|At Day 169|All randomized participants who received study drug.|||percentage of participants|||Number
2816264|NCT00409825|Primary|Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.|"Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.~We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days."|Second and third trimesters of pregnancy||||ng/ML/day||Standard Deviation|Mean
2816265|NCT00409786|Secondary|Physical Activity||1 year|||||||
2816266|NCT00409786|Secondary|Health Related Quality of Life||1 year|||||||
2816267|NCT00409786|Secondary|Fat Consumption||1 year|||||||
2816268|NCT00409786|Secondary|A1C (if Applicable)||1 year|||||||
2816269|NCT00409786|Secondary|Lipid||1 year|||||||
2816270|NCT00409786|Secondary|Blood Pressure||1 year|||||||
2816271|NCT00409786|Primary|Change in Weight||Baseline and 1 year|Of the original 50 participants, 12 month data was collected for 45 (90%) of them. Analysis was conducted on those participants with 12 month data.|||kg||95% Confidence Interval|Mean
2816272|NCT00409773|Secondary|Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Median
2816384|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
2816273|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816274|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816275|NCT00409773|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816276|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6||Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816277|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816278|NCT00409773|Secondary|Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816279|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816280|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816281|NCT00409773|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816282|NCT00409773|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816283|NCT00409773|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816284|NCT00409773|Secondary|Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Median
2816285|NCT00409773|Secondary|Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2816286|NCT00409773|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2824442|NCT00350519|Primary|Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions||Day of surgery until hospital discharge|ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size|||participants|||Number
2816287|NCT00409747|Secondary|Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)|This instrument has two scales - Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline and 6 months|All children completing 6 months of drug and participating in final evaluation|||mean scores on global impression scale||Standard Deviation|Mean
2816288|NCT00409747|Primary|z Score|"The Mann-Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.~Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin"|Pre and post treatment with minocyline at 6 months for 10 subjects|10 subjects completed six months of minocycline and have pre-/post-minocycline CSF samples for analysis.|||Z-score|||Number
2816289|NCT00409708|Primary|The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of micronuclei per 1000 binucleated cells was measured at Baseline ( n=34 , n=29 ) and at the end of treatment, Week 12 (n =34, n= 29), in blood cultured for 48 hours using a standard protocol.|baseline and at end of treatment (Week 12)||||number of micronuclei per 1000 binucleat||Standard Deviation|Mean
2816290|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)|The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient's status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||Units on a rating scale||Standard Deviation|Mean
2816291|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)|The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient's status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||Units on a rating scale||Standard Deviation|Mean
2816292|NCT00409708|Secondary|Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)|"Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked How much of a problem has this been in the last week? parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical."|Baseline to end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||Units on a rating scale||Standard Deviation|Mean
2816293|NCT00409708|Secondary|Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes|Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.|End of treatment (Week 12)||||Number|||Number
2816294|NCT00409708|Secondary|Number of Sister Chromatoid Exchanges Per Cell|Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters.|baseline and at end of treatment (Week 12)|Per-Protocol-2 population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.|||number of sister chromatoid exchanges||Standard Deviation|Mean
2816295|NCT00409708|Primary|The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of chromosomal aberrations per 100 cells excluding gaps at Baseline (n=33, n=32) and at Week 12 (n=33, n=32) was counted in blood samples cultured for 48 hours using a standard protocol. The types of abnormalities included translocations (reciprocal and non-reciprocal), insertions, dicentrics, fragments, inversions, chromatid exchanges (quadriradials and triradials), breaks, and other unusual observations, eg, aneuploidy, tetraploidy or endoreduplication.|baseline and at end of treatment (Week 12)|Per-Protocol-1 (PP1) population: The PP1 population consisted of all patients who were randomized and provided cytogenetic data for at least one of the primary endpoints at baseline and at the Week 12 evaluation.|||number of abnormalities||Standard Deviation|Mean
2816296|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 52 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 52|Intent-to-treat (ITT) population for observed case (OC).|||Scores on a scale||Standard Deviation|Mean
2816385|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
2816297|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 26 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 26|Intent-to-treat (ITT) population for observed case (OC).|||Scores on a scale||Standard Deviation|Mean
2816298|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 52|Intent-to-treat population using non-responder imputation (NRI) method.|||percent of participants|||Number
2816299|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 26|Intent-to-treat population using non-responder imputation (NRI) method.|||percent of participants|||Number
2816300|NCT00409682|Secondary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 52|"Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100 with higher scores indicating more active disease. Clinical remission was defined as PCDAI score of ≤ 10.~The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to treat population."|Week 52|Intent-to-treat population using non-responder imputation method.|||percent of participants|||Number
2816301|NCT00409682|Primary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.|Week 26|Comparison of adalimumab High-Dose versus Low-Dose with respect to the primary efficacy endpoint in the intent-to-treat analysis set as all randomized subjects who received at least one dose of double-blind study medication.|||percent of participants|||Number
2816302|NCT00409617|Secondary|Mean Change in Activity Impairment Score From Baseline to Week 20|Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used. Data for 902 participants were available for calculating change from Baseline at Week 20 of treatment. Missing values were imputed by LOCF.|||Percent activity impairment||Standard Deviation|Mean
2816303|NCT00409617|Secondary|Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20|6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 346 participants for the calculation of mean change in Overall Impairment from Baseline to Week 20. Data were imputed using LOCF.|||Percent total impairment||Standard Deviation|Mean
2816304|NCT00409617|Secondary|Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment|Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 382 participants for the calculation of mean change in Percent Impairment While Working from Baseline to Week 20. Data were imputed using LOCF.|||Percent impairment at work||Standard Deviation|Mean
2816305|NCT00409617|Secondary|Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment|Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 369 participants had data available for calculating change in Percent Work Time Missed. Missing values were imputed using LOCF.|||Percent of work time missed||Standard Deviation|Mean
2816386|NCT00408876|Secondary|Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||Units/Liter||Standard Deviation|Mean
2816306|NCT00409617|Secondary|Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20|10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 907 participants had data available for calculating change in total score of SIBDQ. Missing values were imputed using LOCF.|||Change in total score||Standard Deviation|Mean
2816307|NCT00409617|Secondary|Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.|Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.|Week 20 of treatment|"497 participants who received at least 1 injection of adalimumab (ITT population) had baseline EIM data. Missing data were imputed using non-responder imputation; participants who discontinued the study before Week 20 and participants with missing value at Week 20 were counted as no for resolution."|||Participants|||Number
2816308|NCT00409617|Secondary|Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20|A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.|Week 20 of treatment|171 participants in the ITT population (participants who received at least 1 injection of adalimumab) had draining fistulas at baseline. Data were available for 148 of the 171 participants at Week 20 of treatment. Missing values were not imputed.|||Participants|||Number
2816309|NCT00409617|Secondary|Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"ITT Population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for response."|||Participants|||Number
2816310|NCT00409617|Primary|Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"Intent-to-treat (ITT) population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for remission."|||Participants|||Number
2816311|NCT00409578|Secondary|Percentage of Patients With a Composite Clinical-biochemical Event|A composite clinical-biochemical event was defined as at least one of the following events: cardiovascular death confirmed by adjudication, recurrent MI confirmed by adjudication, hospitalization for CHF confirmed by adjudication, and/or NT-proBNP => 200 pg/mL.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||Percentage of patients|||Number
2816312|NCT00409578|Secondary|Percentage of Patients With a Cardiac Event|A cardiac event was defined as at least one of the following events: Cardiovascular death, recurrent myocardial infarction (MI), or hospitalization for congestive heart failure (CHF), all to be confirmed by adjudication.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||Percentage of patients|||Number
2816313|NCT00409578|Secondary|Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8|Blood samples for the measurement of BNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||pg/mL||95% Confidence Interval|Geometric Mean
2816314|NCT00409578|Primary|Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8|Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.|||pg/mL||95% Confidence Interval|Geometric Mean
2816315|NCT00409565|Secondary|Disease Control Rate (DCR) ((Clinical Benefit Rate (CBR))|"Disease Control Rate (DCR) (or Clinical Benefit Rate (CBR)), is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to cetuximab and bevacizumab.~DCR = number of patients with (at least) partial response or stable disease / total number of evaluable patients"|At 12 weeks|Patients that were evaluable for 'best response' to treatment.|||percentage of participants|||Number
2816316|NCT00409565|Secondary|Change in Serum Cytokine Concentrations|Ratio of serum cytokines concentration after treatment with cetuximab and bevacizumab to baseline serum cytokines concentration, in picogram/milliliter (pg/ml) for 13 different cytokines. [post-treatment (pg/ml) / baseline (pg/ml)]|Up to 5 years|Patients treated with cetuximab and bevacizumab who provided baseline and post-treatment serum samples.|||post-treatment/baseline pg/ml ratio|||Number
2816317|NCT00409565|Secondary|Overall Survival (OS)|The length of time from the start of study/treatment that diagnosed patients are still alive.|Up to 5 years||||months||95% Confidence Interval|Median
2816318|NCT00409565|Secondary|Progression-free Survival (PFS)|PFS is the length of time during and after treatment that patients are alive with the disease but it does not get worse. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI), Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 5 years|All patients included in study are assessed for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.|||Months||95% Confidence Interval|Median
2816319|NCT00409565|Primary|Objective Response Rate (ORR)|ORR is the percentage of patients whose cancer shrunk or disappeared after study treatment. ORR was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 5 years|Assess all patients included in this study for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.|||percentage of participants||95% Confidence Interval|Number
2816320|NCT00409539|Secondary|To Assess the Safety and Tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) Following 8-weeks of Treatment in Patients With Over Active Bladder Syndrome|Treatment emergent adverse event summary|8 Weeks||||participants|||Number
2816321|NCT00409539|Primary|Change From Baseline to Week 8 in the Number of Voids/24 Hours||8 Weeks||||voids/24 hrs.||Standard Error|Least Squares Mean
2816322|NCT00409409|Primary|Average Rhinoconjunctivitis Total Symptom Score (ARTSS)|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.~Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 38.6 days)|The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.|||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
2816323|NCT00409344|Primary|Intensive Care Unit Length of Stay|The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.|1/1/2008||||Days|||Number
2816324|NCT00409344|Secondary|Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed|Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.|1/1/2008||||participants|||Number
2816325|NCT00409344|Secondary|Pharmaco-economics|Did not achieve this outcome due to no enrollment of participants|1/1/2008||||participants|||Number
2816326|NCT00409344|Secondary|Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability|Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome|1/1/2008||||participants|||Number
2816327|NCT00409344|Secondary|Time to Extubation|Did not achieve this outcome due to no enrollment of participants|1/1/2008||||hours|||Number
2816328|NCT00409344|Secondary|Secondary Endpoints Include:Amount of Sedative and Opiates Given|Did not achieve this outcome due to no enrollment of participants|1/1/2008||||milligram of sedative an opiate|||Number
2816329|NCT00409344|Primary|Time to a Successful Spontaneous Breathing Trial.|Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.|1/1/2008||||hours|||Number
2816330|NCT00409331|Primary|12-month Clinically Relevant Salivary Flow (CRSF)|Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.|12 months|No analysis performed; study terminated early due to change in sponsor.||||||
2816331|NCT00409292|Secondary|to Assess Overall Survival Associated With RAD001 in This Patient Population.|Overall survival was defined as the time from study entry until death from any cause.|2 years||||months||Full Range|Median
2816361|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816332|NCT00409292|Secondary|to Assess Response Rate Associated With RAD001 in This Patient Population.|The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.|2 years|Of the 33 patients enrolled, 29 reached restaging. Three patients who did not reach restaging were removed from study because of withdrawal of consent. One patient was removed from study after 8 days of treatment because of worsening of a preexisting perirectal fistula, requiring surgical intervention.|||participants|||Number
2816333|NCT00409292|Secondary|To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.|A total of 33 eligible patients received at least 1 week of study drug and are included in our toxicity analyses.|||participants|||Number
2816334|NCT00409292|Primary|To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.|"The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment.~The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population."|two months|On the basis of prior studies of 2nd line treatment in metastatic pancreatic cancer, we estimated a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this population.|||participants|||Number
2816335|NCT00409240|Primary|Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study|Hemoglobin A1C target was < 7% LDL cholesterol goal of < 100mg/dl or <70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of <130mm Hg|6 months||||participants|||Number
2816336|NCT00409188|Secondary|Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions|Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator.|From first dose up to 42 days after the last dose of the trial treatment|Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated).|||participants|||Number
2816337|NCT00409188|Secondary|One-, Two- and Three-year Survival Rate|The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach.|Years 1, 2, and 3|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.|||percentage of participants|||Number
2816338|NCT00409188|Secondary|Time To Progression (TTP)|Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions.|Up to 66 months|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.|||months||95% Confidence Interval|Median
2816339|NCT00409188|Secondary|Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment.|Up to 66 months|"Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. N signifies the number of participants who were evaluable for this outcome measure."|||months||95% Confidence Interval|Median
2816340|NCT00409188|Primary|Overall Survival|Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.|Up to 66 months|Primary analysis set (modified intention-to-treat [ITT] population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.|||months||95% Confidence Interval|Median
2816341|NCT00409175|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 8, Month 6, 12, 18|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||percentage of participants||95% Confidence Interval|Number
2816342|NCT00409175|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, 12 and 18|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation associated with malnutrition. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
2816343|NCT00409175|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6, 12 and 18|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2816344|NCT00409175|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6, 12 and 18|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2816345|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, 12 and 18|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale: 0=no problem, 4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment, for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2816346|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2816347|NCT00409175|Secondary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6 and 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to <2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0 (normal) to 4 (paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. LOCF method was used; participant who discontinued due to death/LT was set non-responder.|||percentage of participants||95% Confidence Interval|Number
2816348|NCT00409175|Secondary|Change From Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) Score at Month 6, 12 and 18|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
2816362|NCT00408993|Secondary|Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)|Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.|over 12 weeks|Number of randomized patients in each treatment arm for each dosing group|||participants|||Number
2816349|NCT00409175|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2816350|NCT00409175|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than[<] 2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 18|ITTset:randomized participants received atleast(>=)1 dose of study drug, had >=1 post-baseline efficacy assessment for NIS-LL,Norfolk Quality of Life-Diabetic Neuropathy(QOL-DN) or discontinued study due to death/liver transplant(LT).Last-observation-carried-forward(LOCF) used;participant who discontinued due to death/LT was set non-responder.|||percentage of participants||95% Confidence Interval|Number
2816351|NCT00409006|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.|Baseline to date of death from any cause, 12 weeks up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.|||Months||95% Confidence Interval|Median
2816352|NCT00409006|Post-Hoc|Percentage of Participants Who Died During the Study|This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.|Baseline up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.|||Percentage of Participants|||Number
2816353|NCT00409006|Secondary|Duration of Response for Responders|The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.|Time of response to progressive disease or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).|||Months||95% Confidence Interval|Median
2816354|NCT00409006|Secondary|Number of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.|Baseline to measured response or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.|||Participants|||Number
2816355|NCT00409006|Primary|Progression-Free Survival (PFS)|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|Baseline to first observation of disease progression or death, 12 weeks up to 31 months|Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat [ITT] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).|||Months||95% Confidence Interval|Median
2816356|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid|Significantly different laboratory values between the two groups in baseline to endpoint changes|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.|||micromole/Liter||Standard Deviation|Mean
2816357|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides|Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.|||millimole/Liter||Standard Deviation|Mean
2816358|NCT00408993|Secondary|Vital Signs - Blood Pressure|Change from baseline to endpoint in systolic and diastolic blood pressure.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||mm Hg||Standard Error|Least Squares Mean
2816359|NCT00408993|Secondary|Vital Signs - Pulse Rate|Change from baseline to endpoint in pulse rate.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||beats per minute||Standard Error|Least Squares Mean
2816360|NCT00408993|Secondary|Vital Signs - Weight|Change from baseline to endpoint in body weight.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||kilograms||Standard Error|Least Squares Mean
2816364|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816365|NCT00408993|Secondary|Time Course of Change in Patient Global Impression - Improvement Scale|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, over 12 weeks|Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2816366|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816367|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores|Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816368|NCT00408993|Primary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816369|NCT00408928|Secondary|Number of Toxicities Related to Bortezomib (VELCADE®)|Observe the toxicities of VELCADE® when administered to recipients of allogeneic hematopoietic stem cell transplant in the setting of steroid refractory or steroid dependent acute graft-versus-host disease.|Through 30 days post-traeatment||||toxicities|||Number
2816370|NCT00408928|Primary|Response to Bortezomib (VELCADE®)|"Response is the primary endpoint of this study and will be scored on day 21 (3 weeks after the first dose of VELCADE) and every 3 weeks subsequently. Patients who progress or expire before the end of the study will be considered non-responders.~Patients are evaluated for response in an organ if they have AGVHD in that organ at the start of treatment with VELCADE or if AGVHD develops after the start of VELCADE, but before the time period of evaluation. Complete response in an organ is defined as no evidence clinical or biochemical signs of AGVHD. For the overall assessment, it is defined as complete resolution of rash, abnormal LFTs, and absence of diarrhea attributed to AGVHD.~Partial response is defined as a one stage decrease in any organ system without worsening in other organ systems."|Through 30 days post-treatment||||participants|||Number
2816371|NCT00408902|Secondary|Progression-free Survival|Estimated time to progression using the method of Kaplan and Meier.|Up to 4 weeks after completion of study treatment|Intent to treat|||months||Full Range|Median
2816372|NCT00408902|Secondary|Overall Survival|Estimated using the method of Kaplan and Meier.|Followed until progression or death for approximately 3 years|Data was not collected as study closed prior to time period for analysis.||||||
2816373|NCT00408902|Primary|Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)|The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Up to 4 weeks after completion of study treatment|Intent to treat|||participants|||Number
2816374|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Weight||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||kilograms||Standard Error|Least Squares Mean
2816375|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
2816376|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
2816377|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||beats per minute||Standard Error|Least Squares Mean
2816378|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||micromole/Liter||Standard Deviation|Mean
2816379|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||millimole/Liter||Standard Deviation|Mean
2816387|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||Units/Liter||Standard Deviation|Mean
2816388|NCT00408876|Secondary|Adverse Events Reported as Reason for Discontinuation||Baseline to Week 13|Number of all randomized patients.|||participants|||Number
2816389|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816390|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816391|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816392|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Vitality scores range from 4-24 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816393|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Social functioning scores range from 2-10 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816394|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-physical scores range from 4-8 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816395|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-emotional scores range from 3-6 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816396|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Physical functioning scores range from 10-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816409|NCT00408876|Primary|Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 10|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816397|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Mental health scores range from 5-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816398|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). General health scores range from 5-25(higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816399|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Bodily pain scores range from 2-11 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816400|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816401|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816402|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816403|NCT00408876|Secondary|Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||participants|||Number
2816404|NCT00408876|Secondary|Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||participants|||Number
2816405|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816406|NCT00408876|Primary|Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816407|NCT00408876|Primary|Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 12|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816408|NCT00408876|Primary|Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 11|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816410|NCT00408876|Primary|Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 9|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816411|NCT00408876|Primary|Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 8|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816412|NCT00408876|Primary|Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 7|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816413|NCT00408876|Primary|Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 6|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816414|NCT00408876|Primary|Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 5|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816415|NCT00408876|Primary|Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 4|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816416|NCT00408876|Primary|Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 3|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816417|NCT00408876|Primary|Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 2|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816418|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816419|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816420|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816421|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816422|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816423|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2817883|NCT00397540|Primary|1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)|The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.|1,3,5 year|ITT analysis|||participants|||Number
2816424|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816425|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816426|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816427|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816428|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816429|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816430|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score|The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816431|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score|The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816432|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816433|NCT00408876|Secondary|Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from~1 (very much better) to 7 (very much worse)."|Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2816434|NCT00408876|Primary|Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1|Number of randomized patients with a baseline and at least one non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2816435|NCT00408694|Secondary|Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment|Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started treatment|||percentage of participants||95% Confidence Interval|Number
2816774|NCT00406393|Secondary|Time to Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) > 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count > 20,000/mcL for three consecutive measurements over three or more days.|Measured through Day 100||||days||Full Range|Median
2816436|NCT00408694|Secondary|One- and Two-year Overall Survival Rates|Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2816437|NCT00408694|Secondary|One- and Two-year Progression-free Survival Rates|Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2816438|NCT00408694|Secondary|One- and Two-year Loco-regional Progression-free Rates|Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
2816439|NCT00408694|Secondary|One- and Two-year Distant Metastases-free Rates|Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2816440|NCT00408694|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment.|The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval.|From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2816441|NCT00408694|Secondary|Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen|Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals.|From start of treatment to end of treatment (approximately day 109).|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2816442|NCT00408694|Secondary|Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.|Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years.|Eligible patients who started study treatment and survived more than one year.|||percentage of participants||95% Confidence Interval|Number
2816443|NCT00408694|Primary|Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.|Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to one year.|Eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
2816444|NCT00408681|Other Pre-specified|Agents Added to Treat GVHD More Than 3 Days After Enrollment|Any systemic medication given in an effort to control graft-versus-host disease|Up to 100 days after enrollment||||Participants|||Count of Participants
2816445|NCT00408681|Secondary|Causes of Death|Medical condition that made the greatest contribution in causing death|up to 6 years after enrollment||||Participants|||Count of Participants
2816446|NCT00408681|Secondary|Survival|Patients who were alive at the specified time point|2 years after enrollment||||Participants|||Count of Participants
2816447|NCT00408681|Secondary|Survival|Patients who were alive at the specified time point|1 year after enrollment||||Participants|||Count of Participants
2816448|NCT00408681|Secondary|Survival|Patients who were alive at the specified time after enrollment|6 months after enrollment||||Participants|||Count of Participants
2816449|NCT00408681|Secondary|Non-relapse Mortality|Death without prior recurrent or progressive malignancy after transplantation.|2 years after enrollment||||Participants|||Count of Participants
2816450|NCT00408681|Secondary|Recurrent or Progressive Malignancy|Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation|2 years after enrollment||||Participants|||Count of Participants
2816775|NCT00406393|Secondary|Incidence of Acute GVHD|Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.|Measured at Day 100||||percentage of participants||95% Confidence Interval|Number
2817884|NCT00397514|Secondary|Cardio-pulmonary Bypass Time||Baseline and after 20 minutes||||min.||Full Range|Median
2816451|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|9 to 11 weeks after starting treatment with the study product|Only 4 patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
2816452|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|6 to 7 weeks after starting treatment with the study product|Only 3 patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
2816453|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|5 weeks after starting treatment with the study product|Only 1 patient had endoscopic evaluation during this time window.|||Participants|||Count of Participants
2816454|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|4 weeks after starting treatment with the study product|Only 2 patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
2816455|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.|2 to 3 weeks after starting treatment with the study product|Only 8 of the 20 enrolled patients had endoscopic evaluation during this time window.|||Participants|||Count of Participants
2816456|NCT00408681|Secondary|Duration of Treatment With the Study Product|Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate|Up to 6 months||||days||Full Range|Median
2816457|NCT00408681|Primary|Functional Recovery|Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by > 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.|at 28 days after starting treatment with the study product||||Participants|||Count of Participants
2816493|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||kilograms||Standard Deviation|Mean
2817885|NCT00397514|Secondary|QRS Duration||Baseline and after 20 minutes of pacing||||ms||Full Range|Median
2817886|NCT00397514|Secondary|Ventilatory Support|||||||||
2816458|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816459|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816460|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 32, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816461|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816462|NCT00408629|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"RBS ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816463|NCT00408629|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"SFS ranges from 0-3 as follows:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816464|NCT00408629|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816465|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816466|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816467|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2817887|NCT00397514|Secondary|Inotropic Support|||||||||
2816468|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 8|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816469|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816470|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816471|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816472|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816473|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to OL treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816474|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat (ITT) analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label (OL) treatment were considered to be non-remission.|||Percentage of Participants|||Number
2816475|NCT00408603|Secondary|Progression-free Survival (PFS) Using Kaplan-Meier Methods|"PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression.~For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules.~For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules.~For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment."|From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period|Safety population which included all patients who received any amount of vosaroxin|||Days||95% Confidence Interval|Median
2816494|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic|Systolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||mm Hg||Standard Deviation|Mean
2817888|NCT00397514|Secondary|TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)|||||||||
2817889|NCT00397514|Secondary|Incidence of Low Output Syndrome|||||||||
2817890|NCT00397514|Secondary|Systolic Blood Pressure|||||||||
2816476|NCT00408603|Primary|Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria|Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.|GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period|Safety Population which included all patients who received any amount of vosaroxin|||Participants|||Count of Participants
2816477|NCT00408590|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 12 months after last treatment||||Days||Full Range|Median
2816478|NCT00408590|Secondary|Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)|CA-125 tests are measured in units per milliliter (U/mL) and taken every cycle (up to 6-28 day cycles) during treatment and every three months up to 12 months after treatment. The change in CA-125 is calculated as the baseline CA-125 value subtracted by the last recorded value of CA-125 (up to 18 months from baseline.|baseline and up to 18 months||||U/ml||Full Range|Median
2816479|NCT00408590|Secondary|Number of Responses (Complete and Partial, Stable and Progressive Disease)|Responses will be summarized separately for the MV-CEA virus and MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. CA125 levels and time to progression will also be summarized descriptively. Modified Response Evaluation Criteria in Solid Tumors(RECIST v1.0) criteria will be used. For target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD|up to 12 months after last treatment||||participants|||Number
2816480|NCT00408590|Primary|Dose Limiting Toxicity|If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose|up to 12 months after last treatment|All patients that received study drug for at least 4 weeks were evaluated for dose limiting toxicities.|||participants with DLTs|||Number
2816481|NCT00408564|Secondary|Determine the Biomarker Response of CA 19-9 to Therapy||from start up treatment to one year after end of treatment, up to 81 weeks|data for this endpoint was not collected.||||||
2816482|NCT00408564|Secondary|Response Duration in Patients With at Least Partial Response to Treatment||up to 46 weeks after the start of study treatment|data for this endpoint was not collected.||||||
2816483|NCT00408564|Secondary|Response Rate|defined as the total number of subjects whose best response is PR or CR.|up to 46 weeks after the start of study treatment|only includes patients who completed at least 2 cycles of induction chemotherapy.|||Participants|||Count of Participants
2816484|NCT00408564|Secondary|Overall Survival||up to 46 weeks after the start of study treatment||||percentage of participants||95% Confidence Interval|Number
2816485|NCT00408564|Secondary|Number of Participants With Grade 3-4 Adverse Events Reported||from start of study treatment until end of study visit, about 30 weeks||||participants|||Number
2816486|NCT00408564|Primary|Progression-free Survival at 6 Months||up to 46 weeks after the start of study treatment|only includes patients who completed at least 2 cycles of induction chemotherapy.|||percentage of participants||95% Confidence Interval|Number
2816487|NCT00408499|Secondary|Patient Outcome|In the Phase II portion of the study, patients will be followed for both disease free progression by capturing disease progression date and for over all survival by capturing death date.|Patients will be followed until death|44 patients were enrolled into the Phase II portion of the study|||Participants|||Count of Participants
2816488|NCT00408499|Primary|Number of Patients Correlated With Best Overall Response.|To determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.|Every two cycles from first dose to last dose of study drugs||||Participants|||Count of Participants
2816489|NCT00408499|Primary|Number of Patients Experiencing a DLT|Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity|baseline through cycle 1 of treatment||||Participants|||Count of Participants
2816490|NCT00408460|Secondary|Overall Survival||Every 3 months for 5 years||||months||Full Range|Median
2816491|NCT00408460|Secondary|Time to Tumor Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline and every 2 months post treatment until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed up to 5 years.||||months||Full Range|Median
2816492|NCT00408460|Primary|Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Baseline, Week 4 of courses 2, 4 and 6||||Participants|||Count of Participants
2816495|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic|Diastolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||mm Hg||Standard Deviation|Mean
2816496|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate|Pulse rate (heart rate) measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||beats per minute||Standard Deviation|Mean
2816497|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid|Change from baseline to endpoint in uric acid using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||micromole/Liter||Standard Deviation|Mean
2816498|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase|Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||Units/Liter||Standard Deviation|Mean
2816499|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816500|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816501|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816502|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816503|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816504|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.|Over 13 Weeks|Number of re-randomized patients with non-missing response values.|||participants who responded|||Number
2816537|NCT00408408|Primary|Pathologic Complete Response (pCR) of the Primary Tumor in the Breast|Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.|Time of surgery, on average 6 or 13 months||||percentage of patients||95% Confidence Interval|Number
2817891|NCT00397514|Primary|Cardiac Index||Baseline and after 20 minutes of pacing||||L/min/m2||Full Range|Median
2816505|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||participants who responded|||Number
2816506|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816507|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816508|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816509|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816510|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816511|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816512|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816513|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816514|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816553|NCT00408005|Primary|Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)|Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event|4 years from randomization at the end of induction|Includes subjects randomized to Nelarabine versus No Nelarabine|||percent probability||95% Confidence Interval|Number
2816515|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816516|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816517|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816518|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816519|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816520|NCT00408421|Secondary|Weekly Change From Baseline in the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2816521|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816522|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816523|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816524|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816570|NCT00407797|Secondary|Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21|Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.|Week 21 or End of Treatment (early termination)|FAS.|||percent change||Standard Deviation|Mean
2816525|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Deviation|Mean
2816526|NCT00408421|Secondary|Patient Global Impression of Improvement at 13 Week Endpoint|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2816527|NCT00408421|Primary|Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary|This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2816528|NCT00408408|Secondary|Disease-free Survival (DFS)|Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years.|Measured through 5 years after study enrollment|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2B no follow up data for 6 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 3 patients|||percentage of patients||95% Confidence Interval|Number
2816529|NCT00408408|Secondary|Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone|The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics.|24 months after study entry|For Arm 1A there is no followup data for 2 patients; for Arm 2A there is no followup data for 1 patient; for Arm 3A there is no followup data for 3 patients; for Arm 1B there is no followup data for 3 patients; for Arm 2B there is no followup data for 5 patients; and for Arm 3B there is no followup data for 2 patients.|||participants|||Number
2816530|NCT00408408|Secondary|Surgical Complication|Number of patients with Grade 4 or above surgery-related toxicities|24 months after study entry|For Arm 1A there is no follow up data for 8 patients; Arm 1B no follow up data for 8 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 12 patients; Arm 3A no follow up data for 11 patients; Arm 3B no follow up data for 7 patients|||participants|||Number
2816531|NCT00408408|Secondary|Percentage of Cardiac Events||After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry.|||||||
2816532|NCT00408408|Secondary|Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens|The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST.|Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
2816533|NCT00408408|Secondary|Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy|Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.|Assessed at cycle 5 of chemotherapy, on average at 15 weeks|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
2816534|NCT00408408|Secondary|Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens|The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST.|Three to four weeks after the last chemotherapy dose on average 6 or 13 months|For Arm 1A there is no follow up data for 2 patients; Arm 1B no follow up data for 4 patients; Arm 2A no follow up data for 5 patients; Arm 2B no follow up data for 8 patients; Arm 3A no follow up data for 5 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
2816535|NCT00408408|Secondary|Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy|Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.|Assessed at cycle 5 of chemotherapy, on average at 15 weeks|For Arm 1A there is no follow up data for 1 patient; Arm 1B no follow up data for 5 patients; Arm 2A no follow up data for 6 patients; Arm 2B no follow up data for 7 patients; Arm 3A no follow up data for 7 patients; Arm 3B no follow up data for 4 patients|||percentage of patients||95% Confidence Interval|Number
2816536|NCT00408408|Secondary|pCR in the Breast and Nodes|Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|Time of surgery, on average 6 or 13 months|Arm 1A there is no follow up data for 3 patients; Arm 1B no follow up date for 6 patients; Arm 2A no follow up data for 1 patient; Arm 2B no follow up data for 11 patients; Arm 3A no follow up data for 9 patients; and Arm 3B no follow up data for 6 patients|||percentage of patients||95% Confidence Interval|Number
2825032|NCT00344461|Secondary|Patients With Plasma HIV RNA < 50 Copies/mL|The number of participants with plasma HIV RNA < 50 copies/mL|96 weeks.||||Participants|||Count of Participants
2816538|NCT00408317|Other Pre-specified|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft or watery stool. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency on Day 4 for the first treatment period and second treatment period period for total participants was summarized.|Day 4 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||percentage of stools||Standard Deviation|Mean
2816539|NCT00408317|Other Pre-specified|Number of Bowel Movements|Number of bowel movements of each participant was calculated from frequency of stools by the participant per day. Mean daily number of bowel movements on Day 3 for the first treatment period and second treatment period was summarized.|Day 3 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||bowel movements||Standard Deviation|Mean
2816540|NCT00408317|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent (%) CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Nitrogen intake was calculated as protein intake/6.25. Mean percent CNA was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||Percent CNA||Standard Deviation|Mean
2816541|NCT00408317|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent (%) CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|Intent-to-Treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.|||Percent CFA||Standard Deviation|Mean
2816542|NCT00408200|Secondary|Freedom From Atrial Arrhythmia at 6 Months Post Procedure.||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.|||participants|||Number
2816543|NCT00408200|Primary|Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.|||participants|||Number
2816544|NCT00408070|Secondary|Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy||12 months|not assessed; study terminated early||||||
2816545|NCT00408070|Secondary|To Determine the Degree and Type of Toxicity of This Combined Regimen||weekly|not assessed; study terminated early||||||
2816546|NCT00408070|Secondary|Rate of Decline of CA-125||12 months|not assessed; study terminated early||||||
2816547|NCT00408070|Secondary|Response to Treatment (Clinical/Pathological)||12 months|not assessed; study terminated early||||||
2816548|NCT00408070|Primary|Progression Free Survival Rate at 9 Months|This Outcome is measuring the number of particpants who have survived.|9 months||||participants|||Number
2816549|NCT00408005|Secondary|Cumulative Incidence of CNS Relapse for T-ALL by Risk Group|Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation.|4 years from randomization at the end of induction|Includes only low risk, intermediate risk and high risk T-cell Acute Lymphoblastic Leukemia (T-ALL) subjects. There were no low risk participants on Arm II and Arm IV. Patients with CNS3, and Induction Failures are excluded from this analysis.|||percent probability||95% Confidence Interval|Number
2816550|NCT00408005|Primary|Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort|Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|4 years from end of induction|Includes T-cell lymphoblastic lymphoma (T-LLy) patients that are standard risk, high risk and induction failures. All Standard risk T-LLy patients only received Arm I. Induction failures were assigned to Arm II.|||percent probability||95% Confidence Interval|Number
2816551|NCT00408005|Primary|Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)|Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|4 years from randomization at the end of induction|Includes subjects randomized to Capizzi Methotrexate versus High-Dose Methotrexate|||percent probability||95% Confidence Interval|Number
2816552|NCT00408005|Primary|Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)|Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free.|4 years from randomization at the end of induction|Includes only T-cell Acute Lymphoblastic Leukemia (T-ALL) patients randomized to Capizzi Methotrexate (CMTX) versus High-Dose Methotrexate (HDMTX). CNS3 patients non-randomly assigned to HDMTX (Arms III and IV) and Induction failures non-randomly assigned to Arm IV were excluded. T-LLY patients are excluded.|||percent probability||95% Confidence Interval|Number
2819664|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 5 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
2816554|NCT00408005|Primary|Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)|Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|4 years from randomization at the end of induction|Includes only T-cell Acute Lymphoblastic Leukemia (T-ALL) patients randomized to Nelarabine versus No Nelarabine. T-LLY patients are excluded from this analysis. Induction failures non-randomly assigned to Arm IV were excluded from this analysis.|||percent probability||95% Confidence Interval|Number
2816555|NCT00407966|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an Absolute Neutrophil Count of at least 1000/mililiter and a platelet count of 100,000 mililiter, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A complete remission must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the complete remission.|6 months|Total number of participants entered between December 2006 and June 2008|||participants|||Number
2816556|NCT00407888|Secondary|Overall Survival|Count of surviving patients at two years and six years|Up to 6 years.||||Participants|||Count of Participants
2816557|NCT00407888|Secondary|Time to Treatment Failure|Median time from date of start of therapy to date of removal from therapy for reason other than completion, date of first observation of recurrent disease or date of death due to any cause whichever comes first.|Up to 6 years|Outcome measure reported only for those that had an event (death, recurrent disease or removal).|||years||Full Range|Median
2816558|NCT00407888|Secondary|Toxicity Associated With This Regimen||After at least one course of Adriamycin, up to 12 weeks.|Some results reported are only considered amongst patients receiving Trastuzumab (n = 15).|||Participants|||Count of Participants
2816559|NCT00407888|Secondary|Delivered Dose Intensity of the Regimen||After at least one course of Adriamycin, up to 12 weeks.||||percentage of mean administered dose|||Number
2816560|NCT00407888|Primary|Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin||2 years||||Participants|||Count of Participants
2816561|NCT00407797|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.|||scores on scale||Standard Deviation|Mean
2816562|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale|Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b.|Week 21, LOCF|FAS. LOCF=Last Observation Carried Forward.|||scores on scale||Standard Deviation|Mean
2816563|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)|Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.|||scores on scale||Standard Deviation|Mean
2816564|NCT00407797|Secondary|Treatment Satisfaction: Patient General Impression to Change (PGIC)|Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.|||percent of participants|||Number
2816565|NCT00407797|Secondary|Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
2816566|NCT00407797|Secondary|Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
2816567|NCT00407797|Secondary|Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period|Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).|Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
2816568|NCT00407797|Secondary|Percent of Seizure- Free Participants During the Treatment Observation Period|Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).|Week 9 to Week 21 or Early Termination (end of treatment)|FAS. N=number of subjects with evaluable data.|||percent of participants|||Number
2816569|NCT00407797|Secondary|Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period|Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.|||percent change||Standard Deviation|Mean
2816571|NCT00407797|Secondary|Response Ratio (RR)|Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.|||ratio||Standard Deviation|Mean
2816572|NCT00407797|Primary|Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase|28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data.|||percent change||Standard Deviation|Mean
2816573|NCT00407758|Secondary|Prognostic Factor - Age at Study Entry||Baseline|Eligible and treated patients|||years||Inter-Quartile Range|Median
2816574|NCT00407758|Secondary|Prognostic Factor - Initial Performance Status|Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2816575|NCT00407758|Secondary|Prognostic Factor - Number of Patients With Platinum Sensitivity|Platinum sensitive = a platinum-free interval between 6 and 12 months.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2816576|NCT00407758|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||months||90% Confidence Interval|Median
2816577|NCT00407758|Secondary|Duration Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients|||months||90% Confidence Interval|Median
2816578|NCT00407758|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients|||Participants|||Count of Participants
2816579|NCT00407758|Primary|Progression-free Survival > 6 Months Using RECIST 1.0|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
2816580|NCT00407758|Primary|Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.|CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
2816581|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816582|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816583|NCT00407745|Secondary|Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
2816584|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816585|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816586|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816587|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816588|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816589|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816590|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816591|NCT00407745|Secondary|Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)|NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
2816603|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia|Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816592|NCT00407745|Secondary|Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)|NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
2816593|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816594|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816595|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816596|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816597|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816598|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF;(n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816599|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816600|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales|Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816601|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816602|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli|Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816604|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816605|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816606|NCT00407745|Secondary|Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score|"The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale."|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816607|NCT00407745|Other Pre-specified|Change From Baseline in Weekly Mean Sleep Interference Score by Week|Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 1 through 16|ITT; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816608|NCT00407745|Secondary|Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
2816609|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score by Week|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1 through16|ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.|||score on scale||Standard Deviation|Mean
2816610|NCT00407745|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis|||score on scale||Standard Deviation|Mean
2816611|NCT00407745|Secondary|Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)|The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis|||participants|||Number
2816612|NCT00407745|Secondary|Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.|||participants|||Number
2816613|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.|||score on scale||Standard Deviation|Mean
2816614|NCT00407745|Primary|Duration Adjusted Average Change (DAAC) of Mean Pain Score|DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.|Baseline, Week 16|mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.|||score on scale||Standard Error|Least Squares Mean
2816615|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-treated Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;~Stable disease for atleast 16 weeks"|Up to 6 years||||participants|||Number
2816616|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used (Bevacizumab-treated Group)|12 months||||months||95% Confidence Interval|Median
2816617|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used. (Bevacizumab-treated Group)|6 months||||months||95% Confidence Interval|Median
2816618|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-naïve Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;~Stable disease for atleast 16 weeks"|Up to 6 years||||participants|||Number
2816619|NCT00407654|Secondary|Objective Stable Disease Rate||Up to 6 years|data were not collected||||||
2816620|NCT00407654|Secondary|Time to Progression|Kaplan-Meier method will be used.|12 months|data were not collected||||||
2816623|NCT00407654|Primary|Progression-free Survival (Bevacizumab-treated Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)"|4 months||||months||95% Confidence Interval|Median
2816624|NCT00407654|Primary|Progression-free Survival (Bevacizumab- naïve Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)"|4 months||||months||95% Confidence Interval|Median
2816625|NCT00407654|Primary|Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 6 years||||participants|||Number
2816626|NCT00407563|Secondary|Best Overall Response at Six Months|The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Assessed over 6 months of study treatment|The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution.|||percentage of patients||95% Confidence Interval|Number
2816627|NCT00407563|Secondary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.|Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis.|||Months||95% Confidence Interval|Median
2816628|NCT00407563|Secondary|Overall Survival||Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.|Participants who had not experienced death during or after stopping treatment were censored in the analysis.|||Months||95% Confidence Interval|Median
2816629|NCT00407563|Secondary|Best Overall Response|Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.||||Participants|||Number
2816630|NCT00407563|Primary|6-month Progression-Free Rate|Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|6 months after initiation of study treatment||||percentage of patients||95% Confidence Interval|Number
2816631|NCT00407550|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)|All patients that began protocol treatment are included in this analysis.|||Participants|||Count of Participants
2816632|NCT00407550|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Death or last follow-up (up to 2 years)|One patient in Arm B was a major violation and not included in this analysis.|||months||95% Confidence Interval|Median
2816633|NCT00407550|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 2 years)|One patient in Arm B was deemed a protocol violation and was not include din this analysis.|||months||95% Confidence Interval|Median
2816634|NCT00407550|Primary|Number of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~>~> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart (up to 2 years)||||participants|||Number
2816635|NCT00407537|Secondary|Number of Participants With Increase of Treatment Dosages After 4 Months.|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||Participants|||Number
2816636|NCT00407537|Secondary|Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||participants|||Number
2816637|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months|Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||Percentage of participants|||Number
2816638|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months|Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||percentage of participants|||Number
2816639|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2816640|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
2816641|NCT00407537|Secondary|Mean Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||Standard Deviation|Mean
2816642|NCT00407537|Secondary|Mean Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||mg/dL||Standard Deviation|Mean
2816643|NCT00407537|Secondary|Change From Baseline in DBP at Month 12||Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHg||95% Confidence Interval|Least Squares Mean
2816644|NCT00407537|Secondary|Change From Baseline in SBP at Month 12||Baseline, Month 12|FAS, number of participants analyzed refers to number of participants contributing to data.|||mmHg||95% Confidence Interval|Least Squares Mean
2816645|NCT00407537|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHG||95% Confidence Interval|Least Squares Mean
2816646|NCT00407537|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHG||95% Confidence Interval|Least Squares Mean
2816647|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 12||Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||mmHg||Standard Deviation|Mean
2816648|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 4||Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.|||mmHg||Standard Deviation|Mean
2816649|NCT00407537|Secondary|Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||95% Confidence Interval|Least Squares Mean
2816650|NCT00407537|Secondary|Change From Baseline in Framingham 10-year Risk of Developing Total CHD|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||95% Confidence Interval|Least Squares Mean
2816651|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 4|"Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12)."|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
2816652|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 12|"Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12)."|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
2816653|NCT00407537|Secondary|European SCORE 10-year Risk of Fatal CVD at Month 4|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
2816654|NCT00407537|Secondary|European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
2816768|NCT00406393|Secondary|Malignant Disease Relapse|Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.|Measured at Year 2||||percentage of participants||95% Confidence Interval|Number
2816655|NCT00407537|Secondary|Framingham 10-year Risk of Total CHD at Month 4|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
2816656|NCT00407537|Primary|Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.|||percent risk||Standard Deviation|Mean
2816657|NCT00407511|Secondary|Clinical Global Impression of Change (CGIC)|7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)|||participants|||Number
2816658|NCT00407511|Secondary|Patient Global Impression of Change (PGIC)|7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)|||participants|||Number
2816659|NCT00407511|Secondary|Change From Baseline in Mean Daily Sleep Interference Score (DSIS)|Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
2816660|NCT00407511|Secondary|Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)|100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
2816661|NCT00407511|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)|100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
2816662|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.|||scores on scale||Standard Deviation|Mean
2816663|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.|||scores on scale||Standard Deviation|Mean
2816664|NCT00407511|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.|Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
2816665|NCT00407511|Secondary|Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.|||scores on scale||Standard Deviation|Mean
2816666|NCT00407511|Secondary|Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.|Week 4, Week 8, Week 12|Full Analysis Set (FAS).|||scores on scale||Standard Deviation|Mean
2816680|NCT00407030|Secondary|Change From Baseline in the TWSTRS Pain Subscore|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
2816667|NCT00407511|Primary|Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.|Baseline, End of Treatment|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).|||scores on scale||Standard Deviation|Mean
2816668|NCT00407485|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions PFS using the product-limit method of Kaplan and Meier.|From start of treatment to time of progression, assessed up to 4 months||||Months||95% Confidence Interval|Median
2816669|NCT00407485|Primary|Tumor Response Rate|"Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria.~Responders were confirmed partial or complete responses to treatment."|From the start of the treatment until disease progression or recurrence, assessed up to 4 years||||percentage of responders||95% Confidence Interval|Number
2816670|NCT00407420|Secondary|Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA)|Change in % body fat. Calculated as %body fat at end of intervention minus baseline. A negative value being viewed as beneficial outcome.|12 months|90 patients completed the intervention study at 12 months. One additional patient withdrew from study but agreed to data collection at 12 months. Data unavailable for analysis on two patients allocated to Mandometer.|||percentage of body fat||Standard Deviation|Mean
2816671|NCT00407420|Secondary|Speed Food Consumed|Grams of food eaten per minute in Mandometer® arm compared to standard arm at baseline and 12 months. Reducing speed of eating improves satiety and reduces total food consumed at meals in our overall hypothesis.|12 months|In only 23 of control cases was baseline data available on eating speed which then could be analysed for change at 12 months.|||gms/min of food consumed||Full Range|Mean
2816672|NCT00407420|Secondary|Insulin Sensitivity|Insulin sensitivity was measured by the homeostasis model assessment (HOMA-R) equation: HOMA-R = fasting glucose (mmol/l) × fasting insulin (mIU/l)/22.5. The lower the HOMA-R, the more insulin sensitive the participant is which is considered beneficial to metabolic health.|12 months|90 patients completed the intervention study at 12 months. One additional patient withdrew from intervention but agreed to data collection at 12 months. Data unavailable for analysis on one patient allocated to Mandometer.|||Arbitary units||Full Range|Geometric Mean
2816673|NCT00407420|Primary|BMI SDS or Z-score|Body Mass Index standard deviation (s.d.) scores also called Z-scores, are measures of relative weight adjusted for a child's age and sex. In terms of this score for weight management, a lower score would be viewed a beneficial outcome at the end of the intervention. The change in BMI SDS was calculated as the value at 12 months minus value at baseline ( a negative score being beneficial).|12 months primary/ 18 months secondary outcome|The 12 months data includes Z-score of patients completing study (Mandometer arm n=45, Standard arm n=46) and last recorded Z-score of those withdrawing (Mandometer n=9, Control n=6). At 18 months (6 months after intervention ended) data was available on 44 participants in the active (Mandometer group) and 43 from the control arm.|||Z-Score||Standard Deviation|Mean
2816674|NCT00407381|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6|Mean change of best corrected visual acuity letters (BCVA) at month 6|6 months|Mean change in BCVA at month 6|||Mean letter change in BCVA||Standard Deviation|Mean
2816675|NCT00407355|Primary|Retinal Thickness Change From Baseline at All Visits||continuous through 72 mos||||microns||Standard Deviation|Mean
2816676|NCT00407355|Primary|Best Corrected Visual Acuity Change From Baseline at All Visits||continuous through 72 mos||||ETDRS letters||Standard Deviation|Mean
2816677|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Error|Least Squares Mean
2816678|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Error|Least Squares Mean
2816679|NCT00407030|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to 20 weeks after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect"|||points on a scale||Standard Deviation|Mean
2816681|NCT00407030|Secondary|Change From Baseline in the TWSTRS Severity Subscore|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
2816682|NCT00407030|Secondary|Change From Baseline in the TWSTRS Disability Subscore|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
2816683|NCT00407030|Secondary|Change From Baseline in the TWSTRS-Total Score|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Deviation|Mean
2816684|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value|||points on a scale||Standard Error|Least Squares Mean
2816685|NCT00406848|Secondary|Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores|The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816686|NCT00406848|Secondary|Number of Participants With Successful Treatment Outcome|Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed).|Baseline (Week 1) through Week 25|All participants randomized under protocol amendment c,d,e, and that have non-missing successful treatment values.|||participants|||Number
2816687|NCT00406848|Secondary|Change From Baseline in Electrocardiograms|The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval.|baseline (Week 1), Week 25|Participants with a baseline and at least one non-missing post baseline value.|||millisecond (msec)||Standard Error|Least Squares Mean
2816688|NCT00406848|Secondary|Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count|The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count.|baseline (Week 1) through Week 13|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.|||participants|||Number
2816689|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Chloride and Fasting Glucose|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||millimole/liter||Standard Deviation|Mean
2816690|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||Micromole/liter (Fe)||Standard Deviation|Mean
2816691|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Erythrocyte Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||Trillion/Liter||Standard Deviation|Mean
2816769|NCT00406393|Secondary|Treatment-related Mortality||Measured at Day 100 and Year 2||||percentage of participants||95% Confidence Interval|Number
2816692|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Uric Acid|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||micromole/liter||Standard Deviation|Mean
2816693|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Platelet Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.|||billions per liter (bill/L)||Standard Deviation|Mean
2816694|NCT00406848|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation|Adverse Events and Serious Adverse Events leading to study discontinuation.|baseline (Week 1) through Week 25|All randomized patients.|||participants|||Number
2816695|NCT00406848|Secondary|Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)|Sustained Hypertension is defined as supine systolic BP >= 140 (or diastolic BP >= 90) mm Hg and increase from baseline (highest value in baseline visit interval) >= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval.|baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.|||Participants|||Number
2816696|NCT00406848|Secondary|Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study|"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.~A patient has abnormal weight change if the gain or loss is ≥7% compared to baseline."|Baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.|||Participants|||Number
2816697|NCT00406848|Secondary|Change From Baseline in Weight||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.|||kilograms (kg)||Standard Error|Least Squares Mean
2816698|NCT00406848|Secondary|Change From Baseline in Pulse Rate||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2816699|NCT00406848|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.|||mmHg||Standard Error|Least Squares Mean
2816700|NCT00406848|Secondary|Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3|Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach.|Week 3|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||Probability of onset||Standard Error|Least Squares Mean
2816701|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)|Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56.|Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.|||probability of remission||Standard Error|Least Squares Mean
2816702|NCT00406848|Secondary|Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score|Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||probability of response||Standard Error|Least Squares Mean
2816703|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10|Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||probability of remission||Standard Error|Least Squares Mean
2816770|NCT00406393|Secondary|Reactivation of Cytomegalovirus (CMV) Infection||Measured at Year 2||||percentage of participants||95% Confidence Interval|Number
2816704|NCT00406848|Secondary|Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816705|NCT00406848|Secondary|Change From Baseline in the Mini-Mental State Exam (MMSE)|Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816706|NCT00406848|Secondary|Change From Baseline in the Clinical Global Impression-Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816707|NCT00406848|Secondary|Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks|"The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is very much improved, a score of 4 indicates that the patient has experienced no change, and a score of 7 indicates that the patient is very much worse."|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816708|NCT00406848|Secondary|Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores|Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816709|NCT00406848|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores|The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816710|NCT00406848|Secondary|Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items|Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms.|baseline (Week 1), Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.|||units on a scale||Standard Error|Least Squares Mean
2816711|NCT00406848|Secondary|Change From Baseline on the 30-item Geriatric Depression Scale (GDS)|The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816712|NCT00406848|Primary|Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).|baseline (Week 1), Week 13|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.|||units on a scale||Standard Error|Least Squares Mean
2816713|NCT00406783|Other Pre-specified|Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|Baseline|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.|||scores on a scale||Standard Error|Least Squares Mean
2816714|NCT00406783|Other Pre-specified|Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|Baseline|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.|||scores on a scale||Standard Error|Least Squares Mean
2816715|NCT00406783|Secondary|Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|15 days|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.|||scores on a scale||Standard Error|Least Squares Mean
2816716|NCT00406783|Primary|The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|15 days|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.|||scores on a scale||Standard Error|Least Squares Mean
2816717|NCT00406718|Secondary|Schizophrenia Symptoms|Brief Psychiatric Rating Scale (BPRS) expanded version psychosis subscale, mean of items for unusual thought content, auspiciousness, conceptual disorganization, and hallucinations. Higher scores mean greater level of symptomatology. Scores vary from 1 = absent to 7 = severe|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All subjects with a baseline and at least one follow up rating|||units on a scale||Standard Deviation|Mean
2816718|NCT00406718|Primary|Social and Occupational Functioning Assessment Scale (SOFAS) Scores|Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|Patients with baseline and at least one follow up rating|||Units on a scale||Standard Deviation|Mean
2816719|NCT00406718|Primary|Adherence|Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All individuals randomized who had a baseline and at least one follow-up rating|||Percentage of medication taken||Standard Deviation|Mean
2816720|NCT00406692|Secondary|Symbol Digit Modalities Test (DSMT)|Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.|Baseline, Week 12|ITT|||Units on a scale||Standard Error|Mean
2816721|NCT00406692|Primary|Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).|Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.|Week 0- Baseline and Week 12|ITT|||Number of Words||Standard Error|Mean
2816722|NCT00406692|Primary|The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase|The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.|Baseline and Week 12|ITT|||Standard Drinks||Standard Error|Mean
2816723|NCT00406653|Secondary|OL; Number of Participants With Pharmacogenomic Marker Activity|Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of pharmacogenomic marker activity in participants was not conducted for the OL as planned.|||participants|||Number
2816724|NCT00406653|Secondary|OL; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.|||participants|||Number
2816725|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.|||participants|||Number
2816762|NCT00406640|Secondary|Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||Percentage of patients|||Number
2816726|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-169|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.|||participants|||Number
2816727|NCT00406653|Secondary|OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy|Background corticosteroid therapy included prednisone or budesonide.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of corticosteroid use in participants was not conducted for the OL as planned.|||participants|||Number
2816728|NCT00406653|Secondary|MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical remission in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||participants|||Number
2816729|NCT00406653|Secondary|MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical response in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||participants|||Number
2816730|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score is based partly on entries from participant's Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to ~600. Clinical response=CDAI reduction ≥100 or absolute CDAI <150. Clinical remission=CDAI <150. Moderate to severe disease=CDAI ≥220 and ≤450.|Day MP-365|On/after Day MP-1, a defined tapering of corticosteroids was planned if the participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.|||participants|||Number
2816731|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy|Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score < 150), or if the participant's condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.|Day MP-365|On/after Day MP-1, a recommended tapering of corticosteroids was planned if participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned|||participants|||Number
2816732|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.|||units on a scale||Standard Deviation|Mean
2816763|NCT00406640|Secondary|Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||percentage of patients|||Number
2816733|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.|||units on a scale||Standard Deviation|Mean
2816734|NCT00406653|Secondary|MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-169|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for the cohort of participants with clinical remission at both Day MP-169 and Day MP-365 was not conducted for the MP as planned.|||participants|||Number
2816735|NCT00406653|Primary|OL; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population)|||participants|||Number
2816736|NCT00406653|Secondary|MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
2816737|NCT00406653|Secondary|MP; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population. The placebo group was constituted by participants who received abatacept in the IP and underwent drug withdrawal in the MP.|||participants|||Number
2816738|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs) of Special Interest:|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the MP, based on a participant’s received treatment (As Treated Analysis Population)|||participants|||Number
2816739|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the Maintenance Period, based on a participant’s received treatment (As Treated Analysis Population)|||Participants|||Number
2816764|NCT00406640|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.|Baseline and 8 weeks|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
2816740|NCT00406653|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
2816741|NCT00406653|Secondary|IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
2816742|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
2816743|NCT00406653|Secondary|IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.|||participants|||Number
2816744|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the IP, based on a participant’s received treatment (As Treated Analysis Population)|||participants|||Number
2816745|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the Induction Period, based on a participant’s received treatment (As Treated Analysis Population)|||Participants|||Number
2816746|NCT00406653|Secondary|IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day IP-85|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period with both Baseline and post-Baseline measurements.|||units on a scale||Standard Deviation|Mean
2816747|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period|||participants|||Number
2816748|NCT00406653|Secondary|IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period|||participants|||Number
2816749|NCT00406653|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population). The OL was not sized based on power considerations.|||participants|||Number
2816750|NCT00406653|Primary|Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365 (12 months) of maintenance therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. The Maintenance Period was not sized based on power considerations, and thus, no formal statistical hypothesis testing was performed.|||participants|||Number
2816751|NCT00406653|Primary|Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.|||participants|||Number
2816752|NCT00406640|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper.|6 months|Safety population: Randomized patients who took ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with < 4 wks therapy. Patients analyzed varied by time (DVS SR, ESC): End of Therapy (n=264, 267); Taper week 1 (n=217, 227); Taper week 2 (n=222, 223); Post-taper (n=219, 223).|||units on scale||Standard Deviation|Mean
2816753|NCT00406640|Secondary|Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase|Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.|||Percentage of Non-Responders|||Number
2816765|NCT00406393|Secondary|Time to Discharge After Transplant||Measured at Year 2|Insufficient data to report on this outcome measure||||||
2816766|NCT00406393|Secondary|Infections||Measured at Year 2|Insufficient data to report on this outcome measure||||||
2816767|NCT00406393|Secondary|Overall Survival||Measured at Year 2||||percentage of participants||95% Confidence Interval|Number
2825033|NCT00344461|Secondary|Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities|The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities.|Protocol length is 96 weeks||||Participants|||Count of Participants
2816754|NCT00406640|Secondary|Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase|Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.|||Percentage of Non-Responders|||Number
2816755|NCT00406640|Secondary|Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase|Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with baseline HAM-D17 score ≥18, who took ≥1 dose study drug, had ≥1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) but not remission (HAM-D17 score ≤ 7) at the end of the acute phase and continued treatment in the 6-month DB continuation phase.|||percentage of responders|||Number
2816756|NCT00406640|Secondary|Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.|||percentage of responders|||Number
2816757|NCT00406640|Secondary|Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.|||percentage of responders|||Number
2816758|NCT00406640|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline and week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
2816759|NCT00406640|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score.|Baseline and Week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Deviation|Mean
2816760|NCT00406640|Secondary|Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week|CGI-S is a global rating scale that measures the severity of a patient's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with patients who have the same diagnosis (1= normal; 7= extremely ill).|Baseline and 8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
2816761|NCT00406640|Secondary|Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
2816771|NCT00406393|Secondary|Thrombotic Microangiopathy (TMA) Infection|The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.|Measured through Day 100||||percentage of participants||95% Confidence Interval|Number
2816776|NCT00406393|Primary|Rate of Grades II-IV Acute GVHD-free Survival|The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.|Day 114||||percentage of participants||95% Confidence Interval|Number
2816777|NCT00406367|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to week 20 after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect."|||Points on a scale||Standard Deviation|Mean
2816778|NCT00406367|Secondary|Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection|The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values|||Points on a scale||Standard Deviation|Mean
2816779|NCT00406367|Secondary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:~JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)~JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values|||Points on a scale||Standard Deviation|Mean
2816780|NCT00406367|Primary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:~JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)~JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population: all participants randomized were included in the primary efficacy analysis; Last Observation Carried Forward (LOCF) imputation technique used for missing values|||Points on a scale||Standard Error|Least Squares Mean
2816781|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|9 weeks|All randomized participants who received at least one dose of study drug.|||participants|||Number
2816782|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|3 weeks|All randomized participants who received at least one dose of study drug.|||participants|||Number
2816783|NCT00406354|Secondary|Number of Participants Discontinuing Treatment|Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||participants|||Number
2816784|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816785|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816786|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816787|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816788|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816789|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816790|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816791|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores|The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816792|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ODD Score|The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816793|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ADHD Score|The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816794|NCT00406354|Secondary|Impact on Family Scale (FaBel), Total Impact Score|Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816795|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816796|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816797|NCT00406354|Secondary|Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity|"FBB-SSV (Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816798|NCT00406354|Secondary|Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity|"FBB-HKS (Fremdbeurteilungsbogen fur Hyperkinetische Storungen), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816799|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score|The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816800|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score|The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816801|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score|The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816802|NCT00406354|Primary|Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score|The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.|9 weeks|All participants randomized and receiving at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2816803|NCT00406315|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16|The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816804|NCT00406315|Secondary|Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16|GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816805|NCT00406315|Secondary|Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16|The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816806|NCT00406315|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16|The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816807|NCT00406315|Secondary|Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16|The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).|Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816808|NCT00406315|Secondary|Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16|The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816809|NCT00406315|Secondary|Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16|PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||scores on a scale||Standard Deviation|Mean
2816810|NCT00406315|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16|AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.|Baseline, Week 16|Safety population.|||scores on a scale||Standard Deviation|Mean
2816811|NCT00406315|Secondary|Change From Baseline in Waist and Hip Circumference at Week 16|Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||centimeter||Standard Deviation|Mean
2816812|NCT00406315|Secondary|Change From Baseline in Fasting Insulin at Week 16|Fasting insulin value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||microinternational (mciu)/milliliter(mL)||Standard Deviation|Mean
2816813|NCT00406315|Secondary|Change From Baseline in Fasting Glucose at Week 16|Fasting glucose value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||mg/dL||Standard Deviation|Mean
2816814|NCT00406315|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16|HbAlc value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||percent||Standard Deviation|Mean
2816815|NCT00406315|Secondary|Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16|HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||mg/dL||Standard Deviation|Mean
2816816|NCT00406315|Secondary|Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16|Total cholesterol value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.|||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
2816817|NCT00406315|Primary|Change From Baseline in Weight at Week 16|Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.|Baseline, Week 16, Week 16 LOCF|Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.|||kilogram||Standard Deviation|Mean
2816818|NCT00406276|Primary|Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact.|"Period from study entry until disease progression, death, or last date of contact.~Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|6 months||||Months||Full Range|Median
2816819|NCT00406276|Primary|Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.|"Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started."|6 weeks|24 patients received at least 2 cycles of therapy and underwent imaging studies to assess response.|||participants|||Number
2816820|NCT00406133|Secondary|Total Costs: Direct and Indirect Costs|Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09-2042/DC1 (Table 1).|26 weeks|Baseline A1c < 7.0%|||dollars||Standard Error|Mean
2816821|NCT00406133|Secondary|QALW|Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged <18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.|26 weeks|Baseline A1c <7.0%|||weeks||Standard Error|Mean
2827877|NCT00319982|Secondary|Development of Left Ventricular Hypertrophy|The number of participants who developed overt left ventricular hypertrophy during the duration of the trial was analyzed|Baseline through final study visits||||participants|||Number
2816822|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816823|NCT00406133|Other Pre-specified|Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816824|NCT00406133|Other Pre-specified|Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816825|NCT00406133|Post-Hoc|26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)|A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816826|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)|A 26-week A1c level <7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816827|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816828|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816829|NCT00406133|Secondary|Cost-effectiveness of CGM.|Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group|26 weeks|Baseline A1c<7%.|||dollars per QALY|||Number
2816830|NCT00406133|Secondary|Quality of Life|Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.|26 weeks|Participants >= 18 years of age. Pools participants with baseline HbA1c <7.0% and >=7.0%.|||units on a scale||Standard Deviation|Mean
2816831|NCT00406133|Secondary|Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||mg/dl/min||Inter-Quartile Range|Median
2816832|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
2816833|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
2816834|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase in A1c level by >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816835|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||participants|||Number
2816836|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
2816837|NCT00406133|Secondary|Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
2816838|NCT00406133|Secondary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)|The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.|Baseline and 26 weeks|Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).|||Percent||Standard Deviation|Mean
2816840|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
2816841|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
2816842|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
2816843|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
2816844|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Standard Deviation|Mean
2816845|NCT00406133|Secondary|Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||subjects with event|||Number
2816846|NCT00406133|Primary|Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)|The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||minutes/day||Inter-Quartile Range|Median
2816847|NCT00406133|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)|The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.|||Percent||Standard Deviation|Mean
2816848|NCT00406107|Secondary|Change in Macular Volume on OCT From Baseline to Week 54||54 Weeks||||mm cubed||Standard Deviation|Mean
2816849|NCT00406107|Secondary|Change in Central Subfield Thickness on OCT From Baseline to Week 54||54 Weeks||||microns||Standard Deviation|Mean
2816850|NCT00406107|Secondary|Safety Parameters|Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.|54 Weeks||||percentage of participants|||Number
2816851|NCT00406107|Secondary|Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield||54 Weeks|Fifteen patients were enrolled in the pegaptanib 0.3 mg dose group and 5 patients were enrolled in the 1.0 mg dose group.|||microns||Standard Deviation|Mean
2816852|NCT00406107|Primary|Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks||54 Weeks||||ETDRS letters||Standard Deviation|Mean
2816853|NCT00406029|Secondary|Change From Baseline in UPDRS Part 4|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 4 subscale assesses complications of therapy over the past week for a total of eleven question items. The first three questions and question 8 are rated from 0 (best) to 4 (worst), and the remaining seven questions are simple no (0) / yes (1) questions. The total subscale score ranges from 0 to 23. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline date (UPDRS Part 4) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
2816854|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (2 Hours Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled standard deviation were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
2816913|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen||2 years|The analysis population is restricted to the 38 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 69 subjects in the placebo group who had a recurrent UTI with an organism for which sensitivity to TMP-SMZ was assessed.|||participants|||Number
2816855|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (1 Hour Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
2816856|NCT00406029|Secondary|Change From Baseline in UPDRS Part 2|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 2 assesses daily living (13 items scored from 0 [best] to 4 [worst]; total range 0-52). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 2) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
2816857|NCT00406029|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part 1|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 1 assesses mentation (4 items scored from 0 [best] to 4 [worst]; total range 0-16). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 1) for the assessment week was used for analysis.|||Units on a Scale||Standard Deviation|Least Squares Mean
2816858|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 12|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 12) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 12 would be reported as BL >2 to WK12 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 12|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
2816859|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 10|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 10) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 10 would be reported as BL >2 to WK10 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 10|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
2816860|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 8|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 8) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 8 would be reported as BL >2 to WK8 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 8|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
2816861|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 6|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 6) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 6 would be reported as BL >2 to WK6 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 6|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
2816914|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Resistant E. Coli||2 years|The analysis population is restricted to the 30 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 57 subjects in the placebo group who had a recurrent UTI with E. coli for which sensitivity to TMP-SMZ was assessed.|||participants|||Number
2816862|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 4|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 4) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 4 would be reported as BL >2 to WK4 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 4|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
2816863|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 2|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 2) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 2 would be reported as BL >2 to WK2 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 2|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.|||Participants|||Number
2816864|NCT00406029|Secondary|Change From Baseline in Total Sleep Time|Hours spent in the sleep state were recorded using a daily diary at least 3 full days before scheduled visit. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A positive change from baseline means more time asleep and a negative change means less time asleep.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (total sleep time) for the assessment week was used for analysis.|||hours/day||Standard Deviation|Least Squares Mean
2816865|NCT00406029|Secondary|Change From Baseline in Absolute Duration of Dyskinesias|Dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination (that occur in the ON time). Hours spent with dyskinesias (troublesome and not troublesome) were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A negative change from baseline signifies less time spent with dyskinesia.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome and not troblesome dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816866|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (Without Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maint. therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state without troubles. dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (without troubles. dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state without troublesome dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816867|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (With Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state with troublesome dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (troublesome dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816877|NCT00405912|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|"Point prevalence tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question Have you used any type of tobacco,even a puff, in the past 7 days? and (b) Expired Carbon Monoxide equal or less then 8 parts per million."|12 weeks following start of medication||||participants|||Number
2816868|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (no Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Dyskinesias refers to maintenance therapy (e.g., L-dopa) side effects of chorea, dystonia, or in combination. Hours spent in the on state with no dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained from an ANCOVA model with effect for treatment & baseline covariate. A (+) change from baseline signifies more time spent in the on state (no dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with no dyskinesias) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816869|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State"|"On time refers to periods of adequate control of Parkinson disease symptoms (symptoms better or absent). Hours spent in the on state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. A positive (+) change from baseline signifies more time spent in the on state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816870|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the Off State at Each Visit"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). Hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with treatment effect and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) for the assessment week was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816871|NCT00406029|Primary|"Change From Baseline to Endpoint of 12 Weeks in the 3-day Average of Awake Time Per Day Spent in the Off State"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). For baseline and the 12 weeks treatment period, hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. Change from baseline in least squares (LS) means and pooled standard deviation (SD) were obtained from an analysis of covariance (ANCOVA) model with effect for treatment and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and up to 12 weeks|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) was used for analysis."|||hours/day||Standard Deviation|Least Squares Mean
2816872|NCT00405964|Secondary|Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment|AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-85|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
2816873|NCT00405964|Secondary|Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment|The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Day 29|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
2816874|NCT00405964|Primary|Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment|AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-29|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
2816875|NCT00405938|Secondary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months|||||||
2816876|NCT00405938|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.|18 months||||months||95% Confidence Interval|Median
2816882|NCT00405821|Secondary|HIV-1 Viral Load Difference Between Arms|We measured mean annual rate of change in log10 viral load (copies/mL) for each group. We assessed difference in annual rate of change in log10 viral load (copies/mL) between groups.|baseline, 6 months, 12 months, 18 months, 24 months|We measured viral load at baseline and at 6 monthly follow-up visits during 24 months of follow-up for all subjects randomized on this study.|||log10 (copies/mL)||95% Confidence Interval|Mean
2816883|NCT00405821|Secondary|Difference in Number of Episodes of Genital Ulcer Disease Between Arms|We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.|2 years|We conducted monthly clinical assessment for GUD on all randomized subjects during their entire follow-up period on this trial. The number of episodes of GUD is shown below.|||episodes|||Number
2816884|NCT00405821|Primary|Progression to AIDS (CD4+ Less Than 250 Cells/Microliter or World Health Org Stage IV dx, Excluding Esophageal Candidiasis)|Evaluate the effect of acyclovir prophylaxis vs placebo among HIV-1/HSV-2 co-infected individuals on the progression to AIDS (CD4+ less than 250 cells/microliter or World Health Org stage IV disease, excluding esophageal candidiasis)|2 years|Intention to treat analysis of all subjects randomized on the trial meeting the primary endpoint|||participants|||Number
2816885|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816886|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816887|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816888|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816889|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816890|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816891|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816892|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2825117|NCT00343863|Secondary|Number of Participants That Had First Administration of Rescue Medication Within 48 Hours|Count of patients that had first administration of rescue medication within 48 Hours|up to 48 hours of chemotherapy||||Participants|||Count of Participants
2816893|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816894|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816895|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816896|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816897|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816898|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816899|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816900|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816901|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816902|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816915|NCT00405704|Secondary|Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)||2 years|The analysis population excluded 99 subjects in the trimethoprim-sulfamethoxazole group and 95 subjects in the placebo group who did not have stool analyzed at the outcome visit.|||participants|||Number
2816903|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population|||units on a scale||Standard Deviation|Mean
2816904|NCT00405756|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period|Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.|Up to 169 weeks (Double-blind therapy period plus 4 weeks)|Safety population|||participants|||Number
2816905|NCT00405756|Secondary|Kaplan Meier Estimates for Time to Next Antimyeloma Therapy|Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|Up to 168 weeks|Intent to treat population|||weeks||95% Confidence Interval|Median
2816906|NCT00405756|Secondary|Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Up to 149 weeks|Population: Participants who achieved a partial response (PR) or complete response (CR).|||weeks||95% Confidence Interval|Median
2816907|NCT00405756|Secondary|Time to First Response|Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.|Up to 66 weeks|Participants who had a partial response (PR) or complete response (CR)|||weeks||Standard Deviation|Mean
2816908|NCT00405756|Secondary|Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period|Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).|Up to 165 weeks|Intent to treat population|||participants|||Number
2816909|NCT00405756|Secondary|Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent to treat population|||weeks||95% Confidence Interval|Median
2816910|NCT00405756|Secondary|Kaplan Meier Estimates of Overall Survival (OS)|Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier.|up to 177 weeks|Intent to treat population|||weeks||95% Confidence Interval|Median
2816911|NCT00405756|Secondary|Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.~PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Approximately week 37 (start of cycle 10) to week 165|Intent to treat (ITT) population of participants in Arms MPR+R and MPR+p who entered maintenance within the Double-blind Treatment Period|||weeks||95% Confidence Interval|Median
2816912|NCT00405756|Primary|Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent-to-treat population|||weeks||95% Confidence Interval|Median
2816916|NCT00405704|Secondary|Treatment Failure Composite|Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.|2 years||||participants|||Number
2816917|NCT00405704|Secondary|New Renal Scarring on Outcome Scan|New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 82 subjects in the trimethoprim-sulfamethoxazole group and 78 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.|||participants|||Number
2816918|NCT00405704|Secondary|Severe Renal Scarring on Outcome Scan|Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.|||participants|||Number
2816919|NCT00405704|Secondary|Outcome Renal Scarring|Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.|||participants|||Number
2816920|NCT00405704|Primary|Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up||2 years||||participants|||Number
2816921|NCT00405652|Secondary|The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes|The number of participants with subclinical rejection episodes as defined by a steroid-sensitive, clinically relevant increase of AST, ALT, gamma-GT, AP or bilirubin (i.e., elevation of one or more of these enzymes that was considered clinically relevant and showed resolution upon treatment with a slight increase of steroid dosage).|12-20 weeks|Intent to Treat|||Participants|||Number
2816922|NCT00405652|Primary|Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life|Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.|Baseline, End of Study (6-8 weeks)|Intent to Treat Population (No last Observation Carried Forward). The number of participants completing the GSRS at Baseline = 31 and at the End of Study= 29.|||Scores on a Scale||Standard Deviation|Mean
2816923|NCT00405639|Primary|Change in Urinary Sodium Excretion in Response to Saline Load||baseline, 12 weeks||||mEq/min||Standard Deviation|Mean
2816924|NCT00405639|Secondary|Change in Left Ventricular Mass Index|Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.|baseline, 12 weeks||||g/m^2||Standard Deviation|Mean
2816925|NCT00405639|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|baseline, 12 weeks||||ml/min/1.73 m^2||Standard Deviation|Mean
2816926|NCT00405639|Secondary|Change in Urine Flow in Response to Saline Load||baseline, 12 weeks||||ml/min||Standard Deviation|Mean
2816927|NCT00405587|Secondary|Tumor Levels of Phosphorylated Extracellular Signal-Regulated Kinapse (ERK), Cyclin D1, and Ki-67|The immunohisto-chemical analyses of the expression of phosphorylated ERK, cyclin D1, and Ki-67 in tumor-biopsy specimens was performed using hematoxylin and eosin staining.|BL and Day 15|||||||
2816928|NCT00405587|Secondary|Cmax of RO5185426 - Food Effect||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2, Day 8, and Day 16|||||||
2816929|NCT00405587|Secondary|Decrease in Tumor Uptake of 18F-fluorodeoxyglucose (FDG)|Tumor uptake of FDG was assessed by means of positron-emission tomography (PET)|BL and Day 15|||||||
2816930|NCT00405587|Secondary|Mean Dose-Normalized Steady-State Cmax of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2 and Day 8, and Day 16|PK Population: The analysis was planned only for those participants who received 80 or 120 mg dose of RO5185426 up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||ug/mL||Standard Deviation|Mean
2816931|NCT00405587|Secondary|Mean Dose-Normalized Steady-State AUC of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|The analysis was planned only for those participants who received 80 or 120 mg dose of RO5185426 up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
2817600|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2816932|NCT00405587|Secondary|Time to CR or PR Using RECIST v1.0 - Extension: BRAFV600E- Positive Melanoma|Time to CR or PR was defined as the interval between the date of the first treatment to the date of the first documentation of confirmed CR or PR whichever occurred first, and not the date of confirmation at the subsequent tumor assessment. Time to response = Date of first response - initial dose date + 1.|Screening, BL, and up to 168 days|Modified ITT population: Participants with a confirmed CR or PR with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered.|||days||Full Range|Median
2816933|NCT00405587|Secondary|Overall Survival (OS) - Extension: BRAFV600E- Positive Melanoma|OS was the period of time measured from the date of initiation of therapy to the date of the death. In the event of no death prior to study termination or analysis data cutoff, OS was censored at the last known date that the patient was alive as documented on the follow-up case report form. If this date was not available, then the last known alive date from the database was used.|Screening, BL, until PD, or end of efficacy follow-up, up to 444 days|Modified ITT Population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Twenty participants were censored for analysis.|||days||95% Confidence Interval|Median
2816934|NCT00405587|Secondary|Percentage of Participants Who Died - Extension: BRAFV600E- Positive Melanoma||Screening, BL, until PD, or end of efficacy follow-up, up to 444 days|Modified ITT Population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered.|||percentage of participants|||Number
2816935|NCT00405587|Secondary|PFS Using RECIST v1.0 - Extension BRAFV600E Positive Melanoma|PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). For Non-TLs, disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs. In the event of no disease progression or documented death prior to study termination, analysis cutoff, or start of confounding anticancer therapy, PFS was censored at the date of the last evaluable tumor assessment.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 421 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Eight participants were censored for analysis.|||days||95% Confidence Interval|Median
2816936|NCT00405587|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Using RECIST v 1.0 - Melanoma Extension Cohort|PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was defined according to the RECIST criteria (v 1.0) as increase by at least 20% in the sum of the longest diameters of each TL, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. For Non-TLs, PD was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Month 1, 3, 4, 6, 9, and Last event (350) days|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Eight participants were censored for analysis.|||percentage of participants|||Number
2816937|NCT00405587|Secondary|Duration of CR or PR Using RECIST v 1.0 - Extension BRAFV600E- Positive Melanoma|Duration of response for participants with confirmed CR or PR was the period of time measured between the date that the criteria for objective CR or PR (whichever status was recorded first) was met, and the first date that recurrent or PD was objectively documented (or death if before progression). PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). In the event of no disease progression or documented death prior to study termination, analysis cutoff, or initiation of confounding anticancer therapy, duration of response was censored at the date of the last evaluable tumor assessment.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: Participants with confirmed CR or PR with a measurable disease at BL, and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered. Seven participants were censored for analysis.|||days||95% Confidence Interval|Median
2816938|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 - Dose Escalation: MBP Formulation|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
2816947|NCT00405587|Primary|AUC of RO5185426 on Day 1 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||mcg*hr/mL||Standard Deviation|Mean
2816939|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 - Dose Escalation: Original Formulation|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
2816940|NCT00405587|Primary|Percentage of Participants With BOR of CR or PR According to RECIST v1.0 - Extension: BRAFV600E- Positive CRC|BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
2816941|NCT00405587|Primary|Percentage of Participants With a Confirmed and an Unconfirmed Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST Version (v) 1.0 - Extension: BRAFV600E- Positive Melanoma|BOR of confirmed /unconfirmed (total) response was defined as CR or PR recorded from baseline until disease progression/recurrence according to Response Evaluation Criteria In Solid Tumors (RECIST) v 1.0 criteria. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30 percent (%) decrease in the sum of longest diameters of the TLs, taking as a reference the baseline (BL) sum of longest diameters. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)|Modified ITT population: All participants with a measurable disease at BL and completed at least one post-baseline radiographic assessment or discontinued study medication early due to disease progression were considered evaluable for efficacy.|||percentage of participants||95% Confidence Interval|Number
2816942|NCT00405587|Primary|Tmax of RO5185426 on Day 15 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
2816943|NCT00405587|Primary|Tmax of RO5185426 on Day 1 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
2816944|NCT00405587|Primary|Cmax of RO5185426 on Day 15 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15 and pre-morning dose on Day 16|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||microgram/milliliter||Standard Deviation|Mean
2816945|NCT00405587|Primary|Cmax of RO5185426 on Day 1 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||microgram/milliliter||Standard Deviation|Mean
2816946|NCT00405587|Primary|AUC of RO5185426 on Day 15 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Phamacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
2817601|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2816948|NCT00405587|Primary|Tmax of RO5185426 on Day 15 - Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
2816949|NCT00405587|Primary|Tmax of RO5185426 on Day 1 - Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
2816950|NCT00405587|Primary|Cmax of RO5185426 on Day 15 - Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||micrograms per milliliter||Standard Deviation|Mean
2816951|NCT00405587|Primary|Cmax of RO5185426 on Day 1 - Dose Escalation: MBP Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||micrograms per milliliter||Standard Deviation|Mean
2816952|NCT00405587|Primary|Mean RO5185426 Accumulation Ratios - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC|Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.|Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ratio||Standard Deviation|Mean
2816953|NCT00405587|Primary|Mean RO5185426 Accumulation Ratios - Dose Escalation: MBP Formulation|Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.|Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ratio||Standard Deviation|Mean
2816954|NCT00405587|Primary|AUC of RO5185426 on Day 15 - Dose Escalation: MBP Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||mcg*hr/mL||Standard Deviation|Mean
2816955|NCT00405587|Primary|AUC of RO5185426 on Day 1 - Dose Escalation: MBP Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
2816956|NCT00405587|Primary|Time to Peak Concentration (Tmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, pre-morning dose on Day 16|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
2816957|NCT00405587|Primary|Time to Peak Concentration (Tmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation||Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||hours||Full Range|Median
2816958|NCT00405587|Primary|Peak Concentration (Cmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation||Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 15, pre-morning dose on Day 16|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||Micrograms per milliliter||Standard Deviation|Mean
2816959|NCT00405587|Primary|Peak Concentration (Cmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation||Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome.|||Micrograms per milliliter||Standard Deviation|Mean
2816960|NCT00405587|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
2816961|NCT00405587|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation|AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule.|Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose|Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ug*hr/mL||Standard Deviation|Mean
2816962|NCT00405548|Secondary|Left Ventricular (LV) Filling Pressure|LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.|Baseline, 12 weeks||||E/e'||Standard Deviation|Mean
2816963|NCT00405548|Primary|Change in Urinary Sodium Excretion in Response to Saline Load|Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).|Baseline, 12 weeks||||mEq/minute||Standard Deviation|Mean
2816964|NCT00405548|Secondary|Change in Glomerular Filtration Rate (GFR) in Response to Saline Load|Renal or kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/ml/1.73 m^2 of body surface area is considered to be impaired kidney function.|Baseline, 12 weeks||||ml/min/1.73 m^2 body surface area||Standard Deviation|Mean
2816965|NCT00405548|Secondary|Change in Urinary Flow in Response to Saline Load|Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.|Baseline, 12 weeks||||ml/minute||Standard Deviation|Mean
2816966|NCT00405522|Secondary|Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.||This outcome was measured for the duration of the procedure (lumbar puncture).||||Participants|||Count of Participants
2816967|NCT00405522|Primary|Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).||This outcome was measured for the duration of the recovery phase.||||minutes||Full Range|Median
2816968|NCT00405522|Primary|Duration of Apnea|Duration of no respiratory effort|This outcome was measured for the duration of the procedure (lumbar puncture).||||seconds||Full Range|Median
2816969|NCT00405509|Secondary|Severity of Symptom Score - SNEEZING|Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on Day 30||||units on a scale||Standard Deviation|Mean
2816970|NCT00405509|Secondary|Severity of Symptom Score - NASAL CONGESTION|nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30||||units on a scale||Standard Deviation|Mean
2816971|NCT00405509|Secondary|Severity of Symptom Scores - COUGH|Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30||||units on a scale||Standard Deviation|Mean
2816972|NCT00405509|Secondary|Nasal Secretion Weights|Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight|each day for 5 days||||grams||Standard Deviation|Mean
2816973|NCT00405509|Primary|Local Leukotriene Levels|nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels|once a day for 6 days and on day 30||||pg/ml||Standard Deviation|Mean
2816974|NCT00405392|Secondary|Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate|The difference of change in serum CTX from basal value between the two sequences was tested using ANCOVA at 95% confidence interval at 3 months (Visit 3) after the administration. Analysis was done with PP population. Baseline was value at Week 0, Change from baseline was calculated by subtracting Baseline value from value at specified time point.|Baseline (Week 0) and Visit 3 (Week 12)|Per protocol population comprised of any participant, who didn’t violate the study protocol, filled the preference questionnaire at the completion of the study, finished assessment of bone turnover marker, and completed journal of GI symptoms. Only the participants available at the time of assessment were analyzed.|||Percent change||Standard Deviation|Mean
2816975|NCT00405392|Secondary|Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration|Participant's preference for convenient treatment was compared between monthly ibandronate and weekly risedronate. Analysis population was mITT. Preference for convenient treatment was calculated as percentage. Percentage of participants who think once-monthly ibandronate dosing is more convenient over once-weekly risedronate dosing were presented. Those participants who answered the two treatments equally convenient were excluded while reporting.|Visit 4 (Week 24)|mITT Population. Percentages do not sum to 100 because some participants did not express a preference.|||Percentage of particiants|||Number
2827878|NCT00319982|Secondary|Left Ventricular Cavity Size|Change in Left Ventricular End-Diastolic Diameter z-score (Final Value - Baseline Value)|Baseline and final study visits||||z-score units||Standard Error|Mean
2816976|NCT00405392|Primary|Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate|Preference of monthly ibandronate and weekly risedronate was compared. Modified-intention-to-treat (mITT) population was used for analysis. Any participant randomly assigned, received the study drug, and participants were asked to fill the preference questionnaire on completion of study. Preference was calculated as percentage. Data for percentage of participants with preference to once-monthly dosing of ibandronate to the once-weekly dosing of risedronate was presented.|Visit 4 (Week 24)|mITT population was comprised of any participant, who was randomly assigned, received the study drug once more at each phase, filled out the preference questionnaire at the completion of the study. Percentages do not sum to 100 because some participants did not express a preference.|||Percentage of participants|||Number
2816977|NCT00405353|Primary|Whole Brain Atrophy Rate|as assessed by Voxel-Based Morphometry|Baseline and 12 months||||percent change in brain volume||95% Confidence Interval|Mean
2816978|NCT00405288|Post-Hoc|Other Neonatal Health Concerns||neonatal period||||participants|||Number
2816979|NCT00405288|Post-Hoc|Skin Conditions in Neonatal Period||neonatal period||||participants|||Number
2816980|NCT00405288|Post-Hoc|Neonatal Health Concerns-infections|Infections occuring in the neonatal period|neonatal period||||participants|||Number
2816981|NCT00405288|Post-Hoc|Respiratory Neonatal Health Concerns||neonatal period||||participants|||Number
2816982|NCT00405288|Post-Hoc|Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth|Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth|neonatal period||||participants|||Number
2816983|NCT00405288|Secondary|Neonatal Health|Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth|at birth||||participants|||Number
2816984|NCT00405288|Secondary|Low Birth Weight at Birth|Low birth weight (birth weights <2500 grams)|at birth|Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used.|||participants|||Number
2816985|NCT00405288|Secondary|Fetal Distress|Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid|at birth||||participants|||Number
2816986|NCT00405288|Secondary|Prematurity|birth at <37 gestational weeks|at birth||||participants|||Number
2816987|NCT00405288|Secondary|Mode of Delivery|Method of delivery for both groups: vaginal or caesarean section|at birth||||participants|||Number
2816988|NCT00405288|Secondary|Gestational Age at Delivery|Fetal gestational age at delivery|until delivery||||gestational weeks||Standard Deviation|Mean
2816989|NCT00405288|Primary|Birth-weight|Weight of the baby measured in grams at time of birth.|until delivery|Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight.|||grams||Standard Deviation|Mean
2816990|NCT00405275|Primary|Mean 48-week Change in DAS28|"Average difference between 48-week and Baseline DAS28.~The Disease Activity Score for 28 Joints (DAS28) is a well-validated composite outcome measure ranging from 2-10 (higher scores indicating more disease) that incorporates a tender and swollen joint count of 28 joints, a laboratory measure of systemic inflammation (ESR) and a patient-reported general assessment of health on a visual analog scale (ranging from 0-10cm) all into one measure.~Low disease activity is defined as DAS28 ≤ 3.2 units."|48 weeks after baseline assessment|Intention to treat analysis was performed on participants with Week 48 DAS28 data.|||units on a scale||Standard Deviation|Mean
2816991|NCT00405067|Secondary|Percent Change in Body Weight at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816992|NCT00405067|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816993|NCT00405067|Secondary|Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816994|NCT00405067|Secondary|Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline||baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816995|NCT00405067|Secondary|Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816996|NCT00405067|Secondary|Percent Change in HDL-C at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816997|NCT00405067|Secondary|Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816998|NCT00405067|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2816999|NCT00405067|Secondary|Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2817000|NCT00405067|Primary|Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments||Baseline and 12 weeks of treatment||||Percent Change||Standard Deviation|Mean
2817001|NCT00404924|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF)|Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||weeks||Inter-Quartile Range|Median
2819665|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 20 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
2817002|NCT00404924|Primary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||95% Confidence Interval|Median
2817003|NCT00404924|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression||||Weeks||95% Confidence Interval|Median
2817004|NCT00404924|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression||||Participants|||Number
2817005|NCT00404924|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 8 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression.||||Participants|||Number
2817006|NCT00404924|Secondary|Progression-Free Survival (PFS)|Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression||||month||95% Confidence Interval|Median
2817007|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome.|||ng/ml||Standard Deviation|Mean
2817008|NCT00404820|Secondary|Therapy Preference at End of Study (Month 12)|Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.|Month 12|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||Participants|||Number
2817009|NCT00404820|Secondary|Change in Body Height From Baseline to Month 12|Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||cm||Standard Deviation|Mean
2817010|NCT00404820|Secondary|Number of Patients With a Clinical Fracture From Baseline to Month 12|A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||Participants|||Number
2817011|NCT00404820|Secondary|Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12|The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||Units on a scale||Standard Deviation|Mean
2817012|NCT00404820|Secondary|Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12|The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||ng/ml||Standard Deviation|Mean
2817025|NCT00404768|Secondary|Neonatal Weight Gain in Part A and B|Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.|At birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Grams||Standard Deviation|Mean
2817373|NCT00401960|Primary|Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria|Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline|weekly|study terminated due to inadequate enrollment; therefore data not sufficient for planned analysis|||Participants|||Count of Participants
2817013|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.|||ng/ml||Standard Deviation|Mean
2817014|NCT00404768|Secondary|Percentage Reduction From Baseline in Number of Uterine Contractions [>30 Sec] Per Hour Within First 6 Hours of Therapy in Part C|For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose. Baseline was Day 0. Reduction from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percentage reduction from Baseline in number of uterine contractions [>30 sec] per hour within first 6 hours of therapy are presented.|First 6 hours of therapy|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2817015|NCT00404768|Secondary|Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C|Tocolytics are medications used to suppress premature labor. They are given when delivery would result in premature birth. Number of participants who remained undelivered without rescue tocolytic therapy after 48 hours are presented.|48 hours post-dose|Pharmacodynamic Population.|||Participants|||Count of Participants
2817016|NCT00404768|Secondary|Neonatal Length Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (Week 12). Mean neonatal length is presented.|At Birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
2817017|NCT00404768|Secondary|Neonatal Head Circumference Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.|At Birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeteres||Standard Deviation|Mean
2817018|NCT00404768|Secondary|Neonatal Weight Gain Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.|At birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Grams||Standard Deviation|Mean
2817019|NCT00404768|Secondary|Neonatal Apgar Scores (at Birth) Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C|APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition.|1 minute and 5 minute after birth at 4 to 12 weeks post adjusted gestational age|Pharmacodynamic Population.|||Scores on a scale||Standard Deviation|Mean
2817020|NCT00404768|Secondary|Derived Plasma GSK221149 Pharmacokinetic Parameters- Maximum Plasma Concentration (Cmax)|Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.|Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion|Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2817021|NCT00404768|Secondary|Derived Plasma GSK221149 Pharmacokinetic Parameters- Observed Elimination Half-life (T-half) and Time to Maximum Observed Drug Concentration (T-max)|Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.|Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion|Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters|||Hours||Standard Deviation|Mean
2817022|NCT00404768|Secondary|Derived Plasma GSK221149 Pharmacokinetic Parameters- Area Under Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) and Area Under Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC [0 to Last])|Blood samples (approximately 2mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.|Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion|Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters.|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2817023|NCT00404768|Secondary|Neonatal Length Measured at 4-6 Weeks of Age in Part A and B|Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (approximately 4 to 6 weeks of age). Mean Neonatal length is presented.|At birth and follow-up (approximately 4 to 6 weeks of age)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
2817024|NCT00404768|Secondary|Neonatal Head Circumference in Part A and B|Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.|At Birth and Follow-up (Week 12)|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Centimeters||Standard Deviation|Mean
2817026|NCT00404768|Secondary|Neonatal Apgar Scores in Part A and B|APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition.|1 minute and 5 minutes after birth|Pharmacodynamic Population.|||Scores on a Scale||Standard Deviation|Mean
2817027|NCT00404768|Secondary|Number of Participants With Preterm Births in Part C|Preterm is defined as babies born alive before 37 weeks of pregnancy are completed. There are sub-categories of preterm birth, based on gestational age: extremely preterm (<28 weeks) very preterm (28 to <32 weeks). Number of participants with preterm births are presented.|Up to 48 hours post-dose|Pharmacodynamic Population.|||Participants|||Count of Participants
2817028|NCT00404768|Primary|Number of Participants Achieving Uterine Quiescence|Uterine quiescence was defined as 4 contractions per/hour or less with no cervical change within the first 6 hours of therapy. Number of participants (from part A,B,C) achieving uterine Quiescence are presented.|Up to 48 hours post-dose|Pharmacodynamic Population.|||Participants|||Count of Participants
2817029|NCT00404768|Primary|Fetal Heart Rate Monitoring up to 48 Hours|Fetal heart rate monitoring was incorporated to assess fetal tolerability. Fetal heart rate was monitored continuously at 2, 4, 6, 8, 12, 18, 24, 36 and up to 48 hours post-therapy. Mean fetal heart rate is presented. Data for only key-time points values have been presented.|Up to 48 hours post-dose|Pharmacodynamic Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Beats per minute||Standard Deviation|Mean
2817030|NCT00404768|Primary|Number of Participants With 50% Reduction in Uterine Contractions Per Hour in Part A and B|For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose.The number of participants that achieve a reduction of at least 50% in uterine contractions with no cervical change within 6 hours and to maintain that reduction until 12 hours of therapy has been presented.|Up to 48 hours post-dose|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2817031|NCT00404768|Primary|Assessment of Amniotic Fluid Index (AFI)|AFI is a quantitative estimate of amniotic fluid and an indicator of fetal well-being. AFI is the score (expressed in centimetes) given to the amount of amniotic fluid seen on ultrasonography of a pregnant uterus. An AFI between 8 to 18 is considered normal. An AFI < 5 to 6 is considered as oligohydramnios characterized by deficiency of amniotic fluid. An AFI > 18 to 24 is considered as polyhydramnios characterized by excess of amniotic fluid in the amniotic sac.|Up to 48 hours-post dose|Pharmacodynamic Population which comprised of all participants who provided pharmacodynamic data. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Score||Standard Deviation|Mean
2817032|NCT00404768|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|Up to Follow-up (Week 12)|Safety Population.|||Participants|||Count of Participants
2817033|NCT00404768|Primary|Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical Concern|Hematology parameters included complete blood count with red blood cell indices and white blood cell differential, platelet count, human immune deficiency virus, Hepatitis C antibody and Hepatitis B surface antigen. Clinical chemistry parameters included blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, phosphate, chloride, total CO2, calcium, aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyltransferase (GGT), alkaline phosphatase, total bilirubin, uric acid, albumin and total protein. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry and hematology parameter values of potential clinical concern are presented.|Up to 24 hours post-treatment|Safety Population.|||Participants|||Count of Participants
2817034|NCT00404768|Primary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|All scheduled 12-lead ECGs were obtained after the participant was rested in the semi-supine position for approximately 15 minutes. Whenever 12-lead ECGs were performed at the same nominal time as a blood draw or blood pressure and pulse rate measurement, the 12-lead ECG were obtained first. ECGs were repeated or recorded in triplicate and the average value recorded at the investigators discretion. The potential clinical concern range for ECG parameters were: Absolute QT corrected (QTc) interval: >450 milliseconds (msec), Increase from Baseline (Day 0): QTc >60 msec, PR interval: <110 and >220 msec and QRS interval: <75 and >110 msec. All 12-lead ECGs obtained throughout the study day were evaluated for safety and were reviewed by the investigator or investigator designee. Number of participants with electrocardiogram values of potential clinical concern are presented.|Up to Follow-up (Week 12)|Safety Population.|||Participants|||Count of Participants
2817048|NCT00404495|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment.|Baseline to Date of Progression (Up to 1 Year)|Evaluable local population|||months||95% Confidence Interval|Median
2817035|NCT00404768|Primary|Number of Participants With Vital Sign Values of Potential Clinical Concern|Vital signs included blood pressure (systolic and diastolic) and heart rate. Maternal blood pressure and heart rate were measured with the participant in the semi-supine position. Blood pressure was measured in millimeters of mercury (mmHg) and heart rate in beats per minute (bpm). Potential clinical concern range for systolic blood pressure: <85 and >160 mmHg, for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 bpm. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with vital sign values of potential clinical concern are presented.|Up to Follow-up (Week 12)|Safety Population which comprised of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2817036|NCT00404755|Secondary|Clinical Global Impression Scale (CGI)|"The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from~1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse)."|6 weeks or last visit in Phase||||units on a scale||Standard Deviation|Mean
2817037|NCT00404755|Primary|Hamilton Depression Scale (HAM-D)|Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.|6 weeks or last visit in Phase|Participants were included if they were given that medication|||units on a scale||Standard Deviation|Mean
2817038|NCT00404651|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability|Day 0 (pre-each vaccination) up to 7 days post-each dose|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome|||Participants|||Number
2817039|NCT00404651|Secondary|Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).|Day 150 (one month post-dose 3)|Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2817040|NCT00404651|Primary|Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).|Day 150 (one month post-dose 3)|Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2817041|NCT00404651|Primary|Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.|Day 150 (one month post-dose 3)|Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2817042|NCT00404651|Primary|Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.|Day 150 (one month post-dose 3)|Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.|||Participants|||Number
2817043|NCT00404547|Secondary|Assessment of Patient Treatment Satisfaction||12 weeks|||||||
2817044|NCT00404547|Secondary|Assessment of Patient Compliance During the Study||12 weeks|||||||
2817045|NCT00404547|Secondary|Change in Patient Assessment of Asthma Control|"Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement."|At baseline and at week 12|Basis is the ITT population|||participants|||Number
2817046|NCT00404547|Primary|Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)|The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).|At the middle and end of the 12 week treatment period|Basis is the ITT population|||points on a scale||Standard Deviation|Mean
2817047|NCT00404495|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment.|Baseline to Date of Death (Up to 1 Year After Treatment)|All participants. One participant in the Temozolomide + Irinotecan for Medulloblastoma cohort did not have recurrent or refractory medulloblastoma and 3 participants in the Temozolomide + Irinotecan for High-Grade Glioma cohort did not have high-grade glioma, and were not considered evaluable for survival.|||months||95% Confidence Interval|Median
2817049|NCT00404495|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment.|Baseline to Date of Treatment Failure (Up to 1 Year)|Evaluable local population|||months||95% Confidence Interval|Median
2817050|NCT00404495|Secondary|Duration of Response|Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment.|Baseline to Date of Tumor Response (Up to 1 Year)|Evaluable local population. Number of participants analyzed=number of participants who responded.|||weeks||Full Range|Median
2817051|NCT00404495|Secondary|Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study ≥4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Evaluable local population: Participants received at least 1 dose of study medication, had measurable disease under study, at least 1 on-study objective tumor assessment, completed at least 2 cycles of study treatment or progressed. Based on investigator's assessment.|||percentage of participants||95% Confidence Interval|Number
2817052|NCT00404495|Primary|Percentage of Participants With Objective Response of Complete Response or Partial Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Primary Evaluable Population: subset of evaluable population predetermined by 2-stage Optimum Simon design. Medulloblastoma cohort: n=consecutive evaluable participants up to 46 if 6 responses obtained in first 15 evaluable participants. Glioma cohort: n=consecutive evaluable participants up to 29 if 1 response in first 10 evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2817053|NCT00404352|Secondary|Change From Baseline in Expanded Disability Status Score (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||unit on a scale||Standard Deviation|Mean
2817054|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 36 months|Open label (OL) ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.|||days||95% Confidence Interval|Median
2817055|NCT00404352|Secondary|Change From Baseline in Time Constant 2 (T2) Lesion Volume , Time Constant 1 (T1) Hypointense Lesion Volume and Gadolinium Enhanced (Gd+) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T2 lesions, T1 hypointense lesions and (Gd+) lesions.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||cubic millimeter (mm^3)||Standard Deviation|Mean
2817056|NCT00404352|Secondary|Mean Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Hypointense Lesions Per Participant Per Scan|Number of CUA lesions, new T2 lesions, Gd+ lesions and new T1 hypointense lesions were measured by using MRI scans.|Month 24 up to Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||lesions||Standard Deviation|Mean
2817057|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 36 months in participants who presented with FCDE accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 36 months|OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.|||days||95% Confidence Interval|Median
2817200|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.|within the first 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
2817058|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 24 months in participants who presented with first clinical demyelinating event (FCDE) accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 24 months|ITT population included all participants who were randomized to the assigned study treatment.|||days||95% Confidence Interval|Median
2817059|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by magnetic resonance image (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 24 months|Intent-to-treat (ITT) population included all participants who were randomized to the assigned study treatment.|||days||95% Confidence Interval|Median
2817060|NCT00404248|Secondary|Survival|Survival measured from first day of treatment to date of death|time to death - up to 12 months|3 pts still alive at time of analysis|||months||Standard Deviation|Median
2817061|NCT00404248|Secondary|Efficacy - Best Overall Response|Response Criteria: Complete Response (CR): complete disappearance of all tumor, off all steroids, stable or improving neuro exam for min of 4wks; Partial Response (PR): Greater than 50% reduction in tumor size, bi-dimensional MRI/CT, stable steroids, stable or improving neuro for min of 4 wks; Progressive Disease (PD): Progressive neurologic abnormalities not explanined by causes unrelated to tumor progression, or 25% increase in size of tumor by MRI/CT scan, or if new lesion appears; Stable Disease (SD): patient whose clinical status and MRI/CT measurements do not meet the criteria for CR, PR or PD.|About 2 years|3 pt did not have proper scans to be evaluable for analysis|||participants|||Number
2817062|NCT00404248|Secondary|Pharmacokinetics - Terminal Phase Half-life|effect of hepatic enzyme-inducing drugs on PKs|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs for Arm 3 (All EIASD) were collected. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis|||Hour||Standard Deviation|Mean
2817063|NCT00404248|Secondary|Pharmacokinetics - Steady-State Apparent Volume Distribution|"effect of hepatic enzyme-inducing drugs on PKs~Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.~Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs were collected for Arm 3. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis|||Liters||Standard Deviation|Mean
2817064|NCT00404248|Secondary|Pharmacokinetics - Total Body Clearance|"effect of hepatic enzyme-inducing drugs on PKs~Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.~Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|No PKs were collected for the three patients who were treated on Arm 3 (all EIASD). Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis|||Liters/hour||Standard Deviation|Mean
2817065|NCT00404248|Primary|Maximum Tolerated Dose (Phase I) - Dose Limiting Toxicity (DLT)|Dose limiting Toxicity defined as: Treatment related events; absolute neutrophil count </=500 /mm3; platelets count </=25,000/mm3; febrile neutropenia; any grade 3 or 4 non-hematologic toxicity; any delay in starting subsequent course of treatment for >14 days because of incomplete recovery from treatment|First 30 days|"+EIASD on hepatic enzyme-inducing drugs; -EIASE not on hepatic enzyme-induzing drug or drugs that significantly induce the hepatic enzyme.~IV Formulations: +PEG; 10mg/mL solution of PEG 300, hydroxypropyl-B-cyclodextrin & water ; -PEG; 6mg/mL, hydroxypropyl-B-cyclodextrin & water - NEW TC6 formulation"|||Dose Limiting Toxicities (DLT)|||Number
2817066|NCT00404248|Primary|Maximum Tolerated Dose (Phase I)|Using the PEG formulation pts both with and without enzyme inducing antiseizure drugs (EIASD) were treated at Doses 750, 1100, 1700, 2200 mg/day for five days = 28pts Using the PEG free formulation pts with and without EIASD) were treated at 1700 and 2200 mg/day X 5 days = 8pgs|first 30 days of treatment||||mg/day x 5 days|||Number
2817067|NCT00404235|Secondary|Number of Treatment Cycles Administered|Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||cycles||Full Range|Median
2817068|NCT00404235|Secondary|Duration of Response|Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|Up to 3 years|Participants with Complete or Partial response, were analyzed|||months||Full Range|Median
2817081|NCT00403845|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2817069|NCT00404235|Secondary|Time to Disease Progression|Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||Full Range|Median
2817070|NCT00404235|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||Full Range|Median
2817071|NCT00404235|Primary|Tumor Response Rate, as Measured by RECIST Criteria|The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|Up to 2 years||||percentage of participants||90% Confidence Interval|Number
2817072|NCT00404092|Primary|Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis|Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.|End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)||||events|||Number
2817073|NCT00404092|Secondary|Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.|"Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU.~Definitions:~CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.~PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities.~Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.~Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death.~Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal."|End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up|All 46 recruited patients were included in the analysis. 2 (EOT), 16 (4w FU) and 23 (12w FU) outcomes out of 46 were not recorded.|||participants|||Number
2817074|NCT00404079|Secondary|EuroQol-5D||1 year|||||||
2817075|NCT00404079|Secondary|Visual Analogue Scale||1 year|||||||
2817076|NCT00404079|Primary|Roland Morris Disability Questionnaire|The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.|1 year|The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.|||units on a scale (0-24)||Standard Deviation|Mean
2817077|NCT00404066|Secondary|Disease-free Survival (DFS)|Disease-free survival (DFS) is expressed as the percentage of participants who were disease-free and alive at the time of analysis.|42 months (median follow-up)|DFS is reported as the number and percentage of participants who were alive and disease-free at the time of analysis.|||Participants|||Count of Participants
2817078|NCT00404066|Primary|Percentage of Participants With Pathologic Complete Response (pCR)|Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.|12 weeks||||percentage of participants|||Number
2817079|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.|||Liters||Standard Error|Least Squares Mean
2817080|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||90% Confidence Interval|Least Squares Mean
2817082|NCT00403845|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.|||Liters||Standard Error|Least Squares Mean
2817083|NCT00403767|Secondary|All-cause Mortality|The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817084|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death|The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817085|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction|The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817086|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism|The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817087|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke|The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817088|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817089|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817090|NCT00403767|Primary|The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety|The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.|||Patients|||Number
2817091|NCT00403767|Primary|The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817092|NCT00403767|Primary|The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The per-protocol (PP) population consisted of all randomized unique patients excluding those who had specific pre-defined major protocol deviations that occurred by the time of enrollment into the study or during the trial. Site 042012 with GCP violation was excluded.|||Patients|||Number
2817105|NCT00403546|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score|CGI-I is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to baseline. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817093|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2817094|NCT00403754|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2817095|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.|5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||90% Confidence Interval|Least Squares Mean
2817096|NCT00403754|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
2817097|NCT00403585|Secondary|Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event|The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.|Treatment Phase (Weeks 53-156)|ITT Population|||participants|||Number
2817098|NCT00403585|Secondary|Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156|Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively.|Week 104 and 156|All participants achieving viological response, defined as an HBV DNA level ≤ 300. Some participants were not tested at various weeks.|||Participants|||Number
2817099|NCT00403585|Secondary|HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156|Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156|Study ADF103814 ITT Population. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed. Some participants were not tested at various weeks.|||log 10 copies/mL||Standard Deviation|Mean
2817100|NCT00403585|Secondary|Number of Participants Achieving Virological Response at Week 104 & 156|Virological response is defined as HBV DNA level<300 copies/ml|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.|||Participants|||Number
2817101|NCT00403585|Secondary|Number of Participants Achieving ALT Normalization at Week 104 & 156|Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter.|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.|||Participants|||Number
2817102|NCT00403585|Primary|Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Week 156|Study ADF103814 Intent-to-Treat (ITT) Population: All subjects regardless of whether or not the subject completed the planned duration of the study will be analyzed with no data exclusion. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2817103|NCT00403546|Secondary|Change in Schizophrenia Cognition Rating Scale (SCoRS) Score|SCoRS is a 20 item interview-based clinical assessment that evaluates cognitive deficits and the degree to which these deficits impair participants' day-to-day functioning. The following cognitive domains are assessed: attention, memory, working memory, language production, reasoning, problem solving, motor skills, and social cognition. Score ranges from 1 to 10 with a higher score indicating a greater degree of impairment. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817104|NCT00403546|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF is a numeric scale used to rate social, occupational, and psychological functioning of participants. Scores range from 100 (extremely high functioning) to 1 (severely impaired). A positive change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817106|NCT00403546|Secondary|Change From Baseline in Clinical Global Impression- Severity (CGI-S) Score|CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. Score ranges from 1 to 7 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817107|NCT00403546|Secondary|Change From Baseline in the Calgary Depression Rating Scale (CDRS) Total Score|The CDRS was used to assess the level of depression in participants with schizophrenia. The questionnaire consists of 9 questions rated on a 4-point scale from 0 to 3. Total range is 0 to 27 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817108|NCT00403546|Secondary|Change From Baseline in PANSS Negative Subscale Score|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Negative symptoms as defined by the American Psychiatric Association represent a diminution or loss of normal functions and include the following 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817109|NCT00403546|Secondary|Change From Baseline in Positive Subscale Score of PANSS|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Positive symptoms as defined by the American Psychiatric Association refer to an excess or distortion of normal functions and include the following 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Score ranges from 7 to 49 with a higher score indicating a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817110|NCT00403546|Primary|Number of Treatment-emergent Adverse Events During Randomized Trial|Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From Baseline up to Week 8|Safety population includes all participants who received at least one dose of study medication.|||adverse events|||Number
2817111|NCT00403546|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817112|NCT00403546|Primary|Percentage of Participants With Response|Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point|||percentage of participants|||Number
2817113|NCT00403546|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817114|NCT00403546|Primary|Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval >/= 500 msec was reported.|6 hours after dosing of Weeks 1, 2 and 8|All participants with available data at each time point.|||participants|||Number
2817115|NCT00403546|Primary|Vital Signs: Systolic and Diastolic Blood Pressure Levels|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|All participants with available data at each time point.|||mmHg||Standard Deviation|Mean
2817169|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour|At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0.|Within 6 hours Post-First Dose|MITT population|||subjects|||Number
2817116|NCT00403546|Primary|Number of Participants With High and Low Levels in Serum Prolactin Concentration|Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration.|Baseline, Week 8|All participants with available data at each time point.|||participants|||Number
2817117|NCT00403546|Primary|Change From Baseline in the Barnes Akathisia Scale (BAS)|BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 - 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 - 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.|Baseline, Week 2, Week 4, Week 6, Week 8|All participants who had available data at each time point.|||units on a scale||Standard Deviation|Mean
2817118|NCT00403546|Primary|Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)|The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.|Baseline, Week 2, Week 4, Week 6, Week 8|All study participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2817119|NCT00403546|Primary|Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial|Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.|From Baseline up to Week 8|All participants in the randomized trial.|||side effect events|||Number
2817120|NCT00403481|Secondary|Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
2817121|NCT00403481|Secondary|Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 Weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 participants, only 169 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
2817122|NCT00403481|Secondary|Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2817123|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2817124|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements|||mm Hg||Standard Error|Mean
2817125|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
2817126|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 169 had the required measurements for this outcome analysis.|||mm Hg||Standard Error|Mean
2817127|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2817128|NCT00403481|Primary|Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.|||mm Hg||Standard Error|Mean
2817129|NCT00403455|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.|12 weeks|All participants analyzed had a CAPS score of >45 and were DSM-IV positive for PTSD. Both males and females with backgrounds in all ethnic groups were aloud to participate in the study.|||Change in units on a scale||Full Range|Mean
2817130|NCT00403403|Secondary|Duration of Objective Response|Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.|Randomization until progression or lost to follow-up (up to 2 years)|Randomized patients with measurable disease at baseline.|||Months||95% Confidence Interval|Median
2817131|NCT00403403|Secondary|Number of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.~Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):~Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)||||number of participants|||Number
2817132|NCT00403403|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.~Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):~Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population|||Percentage of participants|||Number
2817133|NCT00403403|Secondary|Overall Survival|Duration of overall survival from randomization until death or loss to follow-up|Randomization until death or lost of follow-up (up to 27 months)|Intent-to-treat population|||Months||95% Confidence Interval|Median
2817134|NCT00403403|Primary|Progression-free Survival (PFS)|Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population|||Months||95% Confidence Interval|Median
2817135|NCT00403390|Primary|Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug.||3 points over 16 weeks||||uIU/mL||Standard Error|Mean
2817136|NCT00403273|Secondary|Change in Serum Cytokine (Tumor Necrosis Factor Alpha) Levels at 2-month Post-injection|The change in serum tumor necrosis factor alpha was defined as the difference between the follow-up (2-month) and the baseline value of serum tumor necrosis factor alpha. We compared the mean change in serum tumor necrosis factor alpha levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
2817137|NCT00403273|Secondary|Change in Serum Cytokine (Interferon Gamma) Levels at 2-month Post-injection|The change in serum Interferon Gamma was defined as the difference between the follow-up (2-month) and the baseline value of serum Interferon Gamma. We compared the mean change in serum Interferon Gamma levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
2817138|NCT00403273|Secondary|Change in Serum Cytokine (Eotaxin) Levels at 2-month Post-injection|The change in serum Eotaxin was defined as the difference between the follow-up (2-month) and the baseline value of serum Eotaxin. We compared the mean change in serum Eotaxin levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
2817139|NCT00403273|Secondary|Change in Serum Cytokine (Interleukin 12 p70) Levels at 2-month Post-injection|The change in serum interleukin 12 p70 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 12 p70. We compared the mean change in serum interleukin 12 p70 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
2817255|NCT00402649|Primary|Occurrence of Solicited Adverse Events Among All Subjects|Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.|Days 0-7 post each vaccination||||Participants|||Number
2817140|NCT00403273|Secondary|Change in Serum Cytokine (Interleukin 10) Levels at 2-month Post-injection|The change in serum interleukin 10 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 10. We compared the mean change in serum interleukin 10 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
2817141|NCT00403273|Secondary|McGill Sensory Pain Score|McGill Sensory pain score on 0-33 at 2-month FU visit (higher score is worse)|2-month|patients providing data|||units on a scale||Standard Deviation|Mean
2817142|NCT00403273|Secondary|Change in Serum Cytokine (Interleukin 7) Levels at 2-month Post-injection|The change in serum interleukin 7 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 7. We compared the mean change in serum interleukin 7 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.|Baseline to 2-months|This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.|||pg/ml||Standard Deviation|Mean
2817143|NCT00403273|Secondary|McGill Affective Dimension|McGill Affective Dimension Score on 0-12 scale at 2-months (higher number is worse)|2-month|patients providing data|||units on a scale||Standard Deviation|Mean
2817144|NCT00403273|Secondary|Manual Muscle Strength Testing of Knee Flexion and Extension|Occurence of decrease in strength of knee flexion or extension at any of the follow-up visits, as measured by the Manual muscle strength testing (MMT) with scores ranging 0-5; 0 indicates None: No visible or palpable contraction; 1 indicates Trace: Visible or palpable contraction with no motion; 2 indicates Poor: Full range of motion (ROM) gravity eliminated; 3 indicates Fair: Full ROM against gravity; 4 indicates Good: Full ROM against gravity, moderate resistance; and 5 indicates Normal: Full ROM against gravity, maximal resistance|Upto 6-months|patients providing the data|||participants|||Number
2817145|NCT00403273|Secondary|Number of Participants With Occurrence of Joint Erythema, Warmth, Swelling or Tenderness|Occurence of any of the above clinical features (erythema, warmth, swelling or tenderness) as a new finding compared to the absence of the same feature at baseline|Upto 6 months|patients providing data|||participants|||Number
2817146|NCT00403273|Secondary|QOL: SF-36 Score Physical Functioning Scale, a Generic Health Status Measure|Short Form (SF)-36 physical functioning subscale on 0-100, at 2-month FU visit, as a generic health status measure, with a score ranging from 0 (worst physical functioning) to 100 (best physical functioning), with higher score indicating better physical functioning (higher number is better)|2-month|patients providing data|||units on a scale||Standard Deviation|Mean
2817147|NCT00403273|Secondary|Timed Up-and-go (TUG) Test|Time to get up from a chair, walk 3 meters turn back and sit in the chair in seconds at the 2-month visit (higher number is worse, i.e., taking a longer time to complete the task is worse)|2-month|patients providing data|||seconds||Standard Deviation|Mean
2817148|NCT00403273|Secondary|WOMAC Stiffness (0-100)|WOMAC stiffness subscale score on 0-100 scale at 2-month follow-up visit with scores ranging 0 (no joint stiffness) to 100 (worst joint stiffness), with higher score indicating worse joint stiffness|2-months|patients providing the data|||units on a scale||Standard Deviation|Mean
2817149|NCT00403273|Secondary|Physical Function Subscale of the WOMAC at 2-months|Physical Function subscale score of the WOMAC at 2-months on a 0 (best physical function) to 100 (worst physical function), with higher score indicating worse physical function|2-month|people providing data at 2-months|||units on a scale||Standard Deviation|Mean
2817150|NCT00403273|Secondary|Physician Global Assessment of Response to Treatment|Physician global assessed on an ordinal scale with very much improved category as the outcome of interest (compared to all other categories of global assessment as reference category)|2-month (primary end-point)|2 patients did not have the outcome assessment; 1 lost to FU|||participants|||Number
2817151|NCT00403273|Secondary|Mean Pain VAS (0-10)|VAS pain score at 2-month post-injection; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain) with higher score indicating worse pain|2-months post-injection|patients providing pain VAS data at 2-month FU visit|||units on pain VAS scale||Standard Deviation|Mean
2817152|NCT00403273|Primary|Participants With Clinically Meaningful Improvement in Pain Severity (0-10 cm; Higher Score on Pain Scale is Worse)|2-point reduction in pain Visual Analog Scale (VAS) from baseline to the 2-month follow-up visit, which is considered clinically meaningful Change in Pain Severity; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain)|2-month post-injection|all with follow-up data, allowing only single TKA per participant|||participants|||Number
2817153|NCT00403234|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.|From signed informed consent to 7 days after end of study (approx. 35 days)|The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment.|||participants|||Number
2817154|NCT00403130|Secondary|Overall Survival (OS), All Participants|Overall Survival (OS), based on date of death or last known date alive|6 years||||months||Full Range|Median
2817155|NCT00403130|Secondary|Overall Survival (OS), Confirmed|Overall Survival (OS) as determined by confirmed date of death. Participants without documentation as either alive or deceased as of 6 years from the start of treatment were considered lost-to-follow-up.|6 years||||months||Full Range|Median
2817170|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|12 hours Post-First Dose|MITT population|||subjects|||Number
2817290|NCT00402324|Secondary|Number of Patients Hospitalized Due to Relapse of Mania or Depression.|Number of participants hospitalized as a result of relapse of mania or depression.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients.|||participants|||Number
2817156|NCT00403130|Secondary|Response Rates|"The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).~Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.~Target Nontarget New Lesions Overall Response~Complete Complete None Overall Complete Response~Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)~Partial Not PD None Overall Partial Response~SD Not PD None Overall Stable Disease~PD Any Yes/No Overall PD~Any PD Yes/No Overall PD~Any Any Yes Overall PD~Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate."|24 weeks|Although 24 participants completed treatment, only 13 were evaluable for treatment effect.|||Participants|||Count of Participants
2817157|NCT00403130|Primary|Time-to-Progression (TTP)|Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)|2 years|Disease progression was documented for 9 participants.|||months||Standard Deviation|Median
2817158|NCT00403117|Primary|Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.|Change in mean heart rate as a function of marijuana and naltrexone dose|Baseline compared to 6 week timepoint|A total of 29 participants were included in the final analysis|||Heart rate (beats/minute)||Standard Deviation|Mean
2817159|NCT00403117|Primary|Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose|"Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90.~The task batteries included total correct attempts on a 3-min DSST."|Baseline compared to 6 week timepoint|Data from 29 participants were included in this analysis|||units on a scale||Standard Error|Mean
2817160|NCT00403117|Primary|Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.|"All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana high, good effects of marijuana, and how much marijuana was liked.~Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)"|Baseline compared to 6 week timepoint|Data from 29 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
2817161|NCT00402987|Other Pre-specified|No Perceptible Relief|Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population~Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"|||subjects|||Number
2817162|NCT00402987|Other Pre-specified|First Perceptible Relief|Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population~Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"|||subjects|||Number
2817163|NCT00402987|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM vII)|11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment.|24 hours or immediately prior to taking rescue medication|MITT population|||scores on a scale||Standard Deviation|Mean
2817164|NCT00402987|Other Pre-specified|Subjects Taking Rescue Medication|Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug.|Within 24 hours Post-First Dose|MITT population|||subjects|||Number
2817165|NCT00402987|Other Pre-specified|Treatment Failures on STRRS Questionnaire|Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief.|24 hours Post-First Dose|MITT population|||subjects|||Number
2817166|NCT00402987|Other Pre-specified|Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief.|24 Hours|Number of subjects who achieved Meaningful Relief within 6 hours|||hours||Full Range|Median
2817167|NCT00402987|Other Pre-specified|Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study.|24 Hours|Number of subjects who achieved meaningful relief within 6 hours|||hours||Full Range|Median
2817168|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose|At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0|12 and 24 hours Post-First Dose|MITT population|||subjects|||Number
2817318|NCT00402233|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
2817171|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|2 and 6 hours Post-First Dose|MITT population|||subjects|||Number
2817172|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline.|12 hours Post-First Dose|MITT population|||subjects|||Number
2817173|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline.|2 and 6 hours Post-First Dose|MITT population|||subjects|||Number
2817174|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable|||subjects|||Number
2817175|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population|||subjects|||Number
2817176|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population|||subjects|||Number
2817177|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population|||subjects|||Number
2817178|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|12 and 24 hours Post-First Dose|"Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
2817179|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|2 and 6 hours Post-First Dose|"Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
2817180|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline.|At 12 Hours|MITT population|||subjects|||Number
2817181|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline.|At 6 hours|MITT population|||subjects|||Number
2817182|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
2817183|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
2817184|NCT00402987|Other Pre-specified|Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.|Over 2 hour Period Post-First Dose|MITT population|||units on a scale * hours||Standard Error|Least Squares Mean
2817319|NCT00402194|Primary|Insulin-stimulated Leg Glucose Uptake||3 months||||mmol/min||Standard Deviation|Mean
2817320|NCT00402194|Primary|Leg Blood Flow Response to Insulin||3 months||||Liters/minute||Standard Deviation|Mean
2817185|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
2817186|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
2817187|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
2817188|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population~At 15min the SE was <0.01 for all 3 groups"|||units on a scale * hours||Standard Error|Least Squares Mean
2817189|NCT00402987|Other Pre-specified|Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline.|2 hour period Post-First Dose|MITT population|||units on a scale * hours||Standard Error|Least Squares Mean
2817190|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours post-first dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
2817191|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|Within first 6 hours post-first dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
2817192|NCT00402987|Secondary|Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|12 and 24 hours Post-First Dose|"Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87.~MITT population"|||subjects|||Number
2817193|NCT00402987|Secondary|Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|6 Hours Post-First Dose|MITT population|||subjects|||Number
2817194|NCT00402987|Secondary|Time to Onset of Analgesia|Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.~The median time to onset of analgesia, including all subjects, was >2 hours in each group (time was censored at 2 hours).~Median time and CI were not estimable."|||subjects|||Number
2817195|NCT00402987|Secondary|Time to Meaningful Pain Relief|The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.~The median time to meaningful pain relief, including all subjects, was >2 hours in each group (time was censored at 2 hours)~Median time and CI were not estimable"|||subjects|||Number
2817196|NCT00402987|Secondary|Time to Perceptible Pain Relief|Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug|Within 2 Hours Post-First Dose|"MITT population.~Number of Subjects achieving perceptible pain relief: 77 for celecoxib 50mg/50mg; 67 for celecoxib 100mg (pooled); 46 for placebo~Upper 95% CI for placebo group was >120"|||minutes||95% Confidence Interval|Median
2817197|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose|Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|12 hours|MITT population|||subjects|||Number
2817198|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose|Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|at 6 hours|MITT population|||subjects|||Number
2817199|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||scores on a scale||Standard Error|Least Squares Mean
2819666|NCT00385944|Secondary|MPA to 5 μM ADP|Maximum platelet aggregation to 5 μM ADP was assessed by LTA.|14 days after maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
2817201|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
2817202|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|up to 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale * hours||Standard Error|Least Squares Mean
2817203|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
2817204|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Within First 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"|||units on a scale||Standard Error|Least Squares Mean
2817205|NCT00402987|Primary|Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose|Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.|2 hours Post-First Dose|Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis.|||units on a scale * hours||Standard Error|Least Squares Mean
2817206|NCT00402896|Primary|Median Time to Pleurodesis|Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.|Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks|Twenty eligible participants were analyzed for the primary outcome in the trial, eleven completed 10 weeks of treatment. All twenty participants completed the study.|||Days||95% Confidence Interval|Median
2817207|NCT00402883|Secondary|Overall Survival||18 months|||||||
2817208|NCT00402883|Secondary|To Evaluate the Objective Response Rates||18 months|||||||
2817209|NCT00402883|Primary|Time to Progression||18 months|No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.||||||
2817210|NCT00402831|Secondary|Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose|An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP.|From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)||||Percentage of participants|||Number
2817211|NCT00402831|Secondary|Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose|An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.|From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)|All participants who received at least one dose of study drug and had safety follow-up data are included.|||Percentage of participants|||Number
2817212|NCT00402831|Secondary|Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose|An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.|From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)|All participants who received at least one dose of study drug and had safety follow-up data are included.|||Percentage of participants|||Number
2817213|NCT00402831|Secondary|Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.|||Antibody titres (gpELISA units/mL)||95% Confidence Interval|Geometric Mean
2817214|NCT00402831|Secondary|Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.|||Antibody titres (IU/mL)||95% Confidence Interval|Geometric Mean
2817215|NCT00402831|Secondary|Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre <10 ELISA Ab units mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.|||Antibody titres (ELISA Ab units/mL)||95% Confidence Interval|Geometric Mean
2817216|NCT00402831|Secondary|Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment|Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to measles and who had post-vaccination serology results were included.|||Antibody titres (mIU/mL)||95% Confidence Interval|Geometric Mean
2817217|NCT00402831|Secondary|Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose|Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL.|Week 4|Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.|||Antibody titres (gpELISA units/mL)||95% Confidence Interval|Geometric Mean
2817218|NCT00402831|Secondary|Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose|Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL.|Week 4|Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.|||Antibody titres (IU/mL)||95% Confidence Interval|Geometric Mean
2817219|NCT00402831|Secondary|Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose|Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres <10 ELISA Ab units mL.|Week 4|Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.|||Antibody titres (ELISA Ab units/mL)||95% Confidence Interval|Geometric Mean
2817220|NCT00402831|Secondary|Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose|Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL.|Week 4|Participants who were initially seronegative to measles and who had post-vaccination serology results were included.|||Antibody titres (mIU/mL)||95% Confidence Interval|Geometric Mean
2817221|NCT00402831|Secondary|Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose|Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Week 4|Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.|||Percentage of participants||95% Confidence Interval|Number
2817222|NCT00402831|Primary|Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment|Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.|Week 10 (6 weeks after Dose 2 on Week 4)|Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.|||Percentage of participants||95% Confidence Interval|Number
2817223|NCT00402779|Primary|Oral Cancer-free Survival in Participants Receiving Erlotinib as Compared With the Control Arm or Placebo Group.|Cancer-free survival defined as time from randomization to the development of histologically confirmed oral cancer.|3 years||||Participants|||Count of Participants
2817224|NCT00402740|Secondary|Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.||3 years|ITT|||Event-free percentage|||Number
2817225|NCT00402740|Secondary|Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax|Includes only each subject's first occurrence of each event.|≤30 days|ITT|||percentage of participants||95% Confidence Interval|Number
2817226|NCT00402740|Secondary|Procedural Success|Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.|30 Days|ITT|||percentage of participants||95% Confidence Interval|Number
2817227|NCT00402740|Secondary|Acute Device Success|Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.|Post-procedure|ITT|||percentage of participants||95% Confidence Interval|Number
2817228|NCT00402740|Primary|Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.|Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.|3 years|Intent to Treat (ITT)|||Event-free percentage|||Number
2817374|NCT00401960|Primary|Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)|Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details|weekly|Study terminated due to insufficient enrollment; therefore data not sufficient for planned analysis|||Participants|||Count of Participants
2817229|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.|||percentage of participants|||Number
2817230|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.|||percentage of participants|||Number
2817231|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.|||percentage of participants|||Number
2817232|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.|||percentage of participants|||Number
2817233|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.|||percentage of participants|||Number
2817234|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.|||percentage of participants|||Number
2817235|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population|"Clinical response was evaluated by the investigator and graded as resolution, or failure to respond, or indeterminate at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs."|after 7 - 21 days of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.|||percentage of participants|||Number
2817236|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population|"Clinical response was evaluated by the investigator and graded as resolution, or failure to respond, or indeterminate at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs."|after 7 - 21 days of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.|||percentage of participants|||Number
2817237|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population|"Clinical response was evaluated by the investigator and graded as improvement in signs and symptoms, or failure to respond, or indeterminate at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs"|3 - 5 days after start of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.|||percentage of participants|||Number
2817375|NCT00401882|Secondary|Need for Additional Antiarrhythmic Drugs||120 minutes|Data point not analyzed||||||
2817376|NCT00401882|Secondary|Total Duration of Resuscitative Efforts||120 minutes|Data point not analyzed||||||
2817238|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population|"Clinical response was evaluated by the investigator and graded as improvement in signs and symptoms, or failure to respond, or indeterminate at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs."|3 - 5 days after start of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.|||percentage of participants|||Number
2817239|NCT00402727|Secondary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population|"Clinical response was evaluated by the DRC and graded as cure, failure or indeterminate at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs."|14 - 28 days after last dose of study medication|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as all randomized subject that received at least one dose of study medication and had at least one observation after intake of study drug.|||percentage of participants|||Number
2817240|NCT00402727|Primary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population|"Clinical response was evaluated by the DRC and graded as cure, failure or indeterminate at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs."|14 - 28 days after last dose of study medication|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.|||percentage of participants|||Number
2817241|NCT00402714|Secondary|Overall Survival||2 years following stem cell transplant||||participants|||Number
2817242|NCT00402714|Primary|Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis||Day +100 following allogeneic stem cell transplant||||participants|||Number
2817243|NCT00402688|Secondary|Total NIH-CPSI Score|National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life).|Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)|Modified Intent to Treat (mITT)|||Score on a scale||Full Range|Mean
2817244|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone Contact at 6 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)|||Participants|||Number
2817245|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 3 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)|||Participants|||Number
2817246|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 6 weeks|Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit)|||participants|||Number
2817247|NCT00402688|Secondary|Symptom Relief (Resolved)|Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)|||Participants|||Number
2817248|NCT00402688|Primary|Clinical Success|Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)|||Participants|||Number
2817249|NCT00402649|Primary|Occurrence of Serious Adverse Events|Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.|6 months after the first vaccination||||Participants|||Number
2817250|NCT00402649|Primary|Occurrence of Unsolicited Adverse Events|Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Through Day 28 after second vaccination||||Participants|||Number
2817251|NCT00402649|Primary|Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10|Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.|Days 0-7 post each vaccination|Solicited symptom of Body Aches was collected from subjects age 6-10 only|||Participants|||Number
2817252|NCT00402649|Secondary|Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers|Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants post vaccination, but missing baseline assessment for 3 of 16 subjects|||Participants|||Number
2817253|NCT00402649|Secondary|Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers|Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants|||Titer||95% Confidence Interval|Geometric Mean
2817254|NCT00402649|Secondary|Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater|Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants|||Participants|||Number
2817377|NCT00401882|Secondary|Number of Precordial Shocks Required After the Administration of Metoprolol or Epinephrine||120 minutes|Data point not analyzed||||||
2817256|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.|||Patients|||Number
2817257|NCT00402597|Secondary|The Number of Deaths (All Cause)|The number of patients who died due to any cause from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.|||Patients|||Number
2817258|NCT00402597|Secondary|The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke|The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake.|||Patients|||Number
2817259|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake.|||Patients|||Number
2817260|NCT00402597|Primary|The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)|The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.|||Patients|||Number
2817261|NCT00402597|Primary|Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)|The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.|Day 1 to Day 210|The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.|||Patients|||Number
2817262|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.|||recurrences||Inter-Quartile Range|Median
2817263|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.|||recurrences||Inter-Quartile Range|Median
2817264|NCT00402363|Secondary|Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period|Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants who had a rescue episode.|||rescue episodes||Inter-Quartile Range|Median
2817265|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
2817266|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
2817267|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
2817378|NCT00401882|Secondary|Adverse Effects||30 days||||Participants|||Count of Participants
2817268|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.|||participants|||Number
2817269|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
2817270|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
2817271|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population|||participants|||Number
2817272|NCT00402363|Secondary|Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population|||participants|||Number
2817273|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
2817274|NCT00402363|Secondary|Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population|||participants|||Number
2817275|NCT00402363|Secondary|Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population|||participants|||Number
2817276|NCT00402363|Primary|Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter|"A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent|||participants|||Number
2817379|NCT00401882|Secondary|Survival to Hospital Discharge|the number of patients who are alive at hospital discharge|from time of arrest to discharge or death||||Participants|||Count of Participants
2817380|NCT00401882|Primary|Return of Spontaneous Circulation|The patient will be evaluated for sufficiently stable and organized rhythm and blood pressure.|After electrical defibrillation||||Participants|||Count of Participants
2817277|NCT00402337|Secondary|Change From Baseline in Straining Score for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis."|||units on a scale||Standard Error|Least Squares Mean
2817278|NCT00402337|Secondary|Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period|Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis."|||units on a scale||Standard Error|Least Squares Mean
2817279|NCT00402337|Secondary|Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period|CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."|||CSBMs per week||Standard Error|Least Squares Mean
2817280|NCT00402337|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks.~For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."|||participants|||Number
2817281|NCT00402337|Secondary|SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks.~For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."|||participants|||Number
2817282|NCT00402337|Primary|Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency|Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.|Change from Baseline to Week 4|307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 “How many bowel movements did you have today or yesterday since your last call?” were included in the intent-to-treat (ITT) Population.|||SBMs per week||Standard Error|Least Squares Mean
2817283|NCT00402324|Secondary|Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)|Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||percentage of participants|||Number
2817284|NCT00402324|Secondary|Clinically Significant Vital Signs - Weight Change From Baseline|Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||kilograms||Standard Error|Least Squares Mean
2817285|NCT00402324|Secondary|Clinically Significant Vital Signs - Body Mass Index Change From Baseline|Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||kilograms per square meters||Standard Error|Least Squares Mean
2817286|NCT00402324|Secondary|Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline|Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
2817287|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline|Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||milligrams per deciliter||Standard Deviation|Mean
2817288|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline|Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||milligrams per deciliter||Standard Deviation|Mean
2817289|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline|Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and at least one post-baseline measure. Intention to Treat analysis.|||milligrams per deciliter||Standard Deviation|Mean
2817291|NCT00402324|Secondary|Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint|CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (6 weeks)|Intent to Treat analysis. Number of randomized patients with baseline and at least one nonmissing postbaseline value. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2817292|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Response|The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||participants|||Number
2817293|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Onset of Action|The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.|||participants|||Number
2817294|NCT00402324|Primary|Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.|The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2817295|NCT00402324|Primary|Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
2817296|NCT00402285|Primary|Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2|Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.|baseline through 3 month|1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.|||fold change||Standard Deviation|Mean
2817297|NCT00402246|Secondary|In-office Follow-up Burden: Hours Absent From Work Due to Visit|Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.|||Hours||Standard Deviation|Mean
2817298|NCT00402246|Secondary|In-office Follow-up Burden: Patient Expenses|On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.|||Dollars||Standard Deviation|Mean
2817299|NCT00402246|Secondary|In-office Follow-up Burden: Distance Traveled|Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.|1 month visit|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.|||Miles||Standard Deviation|Mean
2817300|NCT00402246|Secondary|Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).|Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device|After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject|All surveys in which clinician completed at least a subset of the questions were included.|||Units on a scale||Standard Deviation|Mean
2817301|NCT00402246|Secondary|Trait-Anxiety Scale|The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2817302|NCT00402246|Secondary|State-Anxiety Scale|The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 month visit|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2817303|NCT00402246|Secondary|Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)|"LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time.~The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds."|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who were implanted with a Concerto CRT-D (Cardiac Resynchronization Therapy with Defibrillation)device, met inclusion/exclusion criteria, and had daily LVCM measurement for at least one of the 6 scheduled visits/transmissions were included in the analysis.|||Volts||Standard Deviation|Mean
2817304|NCT00402246|Secondary|CareLink Transmission Compliance|The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent.|3, 6, 9, 12 months visits|9 of 1014 remote arm subjects did not meet the inclusion/exclusion criteria and were excluded from the analysis. The remaining 1005 remote arm subjects were included in the analysis.|||Proportion of subjects||95% Confidence Interval|Mean
2817305|NCT00402246|Other Pre-specified|Length of Hospital Stay (LOS)|LOS per cardiovascular hospitalization|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.|||Days||Standard Error|Mean
2817306|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations|Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|From event onset to clinical decision|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.|||Days||Standard Deviation|Mean
2817307|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations|Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.|||Days||Standard Deviation|Mean
2817308|NCT00402246|Secondary|AT/AF Alert Treatment|Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who had at least one AT/AF alert were included in the analysis.|||Alerts|Participants||Number
2817309|NCT00402246|Secondary|Symptomatic AT/AF Alerts|AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis.|||Alerts|Participants||Number
2817310|NCT00402246|Secondary|Clinically Meaningful Alerts|Count of clinically meaningful alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis.|||Alerts|Participants||Number
2817311|NCT00402246|Secondary|Actions Taken for HCU Visits|Count of HCU visits that involved specific actions taken|Enrollment to last visit (up to 15 month post-implant)||||Visits|||Number
2817312|NCT00402246|Secondary|Health Care Utilization: TEEs|Count of Transesophageal echocardiograms (TEEs) performed|Enrollment to last visit (up to 15 months post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.|||Procedures|||Number
2817313|NCT00402246|Secondary|Health Care Utilization (HCU)|Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits)|Enrollment to last visit (up to 15 month post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.|||Visits|||Number
2817314|NCT00402246|Primary|Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues|Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery).|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective.|||days||Inter-Quartile Range|Median
2817315|NCT00402233|Secondary|Beck Depression Inventory II|Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
2817316|NCT00402233|Secondary|Epworth Sleepiness Scale|Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
2817317|NCT00402233|Secondary|Modified Hoehn and Yahr Stage|Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)|From baseline to week 12|Treated set|||units on a scale||Standard Deviation|Mean
2817321|NCT00402168|Secondary|Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.|Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized.|||participants|||Number
2817322|NCT00402168|Secondary|Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch|Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.|Day of Switch (first belatacept dose) to Week 96 Post Switch|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized. n=number of participants with data available at specific time point|||mL/min/1.73 m^2||Standard Deviation|Mean
2817323|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||mmHg||Standard Deviation|Mean
2817324|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||mmHg||Standard Deviation|Mean
2817325|NCT00402168|Secondary|Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period|Upper limits of normal (ULN). Hemoglobin: < 8 g/dL; Platelet count: < 50*10^9 c/L; Leukocytes: < 2.0*10^3 c/µL; Lymphocytes (absolute): < 0.5*10^3 c/µL; Neutrophils: < 1.0*10^3 c/µL; Alanine Aminotransferase (ALT): > 5.0*ULN Units per liter (U/L); bilirubin: > 3.0*ULN mg/dL; Creatinine: > 3.0*ULN mg/dL; Calcium: < 7 mg/dL; Bicarbonate: > 12.5 mg/dL; Potassium: < 3.0 meq/L or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL.|Baseline (Screening), up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||participants|||Number
2817326|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period|Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.|Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.|||mg/dL||Standard Deviation|Mean
2817327|NCT00402168|Secondary|Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
2817328|NCT00402168|Secondary|Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
2817406|NCT00401778|Primary|Inhibition of Proliferation (Ki67) and Induction of Apoptosis (TUNEL Assay) in Tumor Specimens and Buccal Mucosa.||6 months|||||||
2817329|NCT00402168|Secondary|Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Baseline (screening) up to Month 36 post randomization|Participants without pre-randomization diabetes, who were randomized and entered LT Period.|||percentage of participants||95% Confidence Interval|Number
2817330|NCT00402168|Secondary|Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period|Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.|Post Months 24, 36, 48, up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
2817331|NCT00402168|Secondary|Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period|AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.|Post Month 12 up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||participants|||Number
2817332|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period|ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.|Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|Participants randomized to their original treatment arm who entered the LT Period (ITT - LT) and had data at baseline and at specific timepoints . Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).|||mL/min/1.73 m^2||Standard Deviation|Mean
2817333|NCT00402168|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants|Upper limits of normal (ULL). Leukocytes: < 2.0*10^3 cells per microliter (c/µL); Lymphocytes (absolute): < 0.5*10^3 c/µL; bilirubin: > 3.0*ULN milligrams per deciliter (mg/dL); Potassium: < 3.0 milliequivalents per liter (meq/L) or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL. Baseline = value at screening.|Baseline up to Month 12|All randomized participants who received at least one dose of study drug and had a laboratory value available post randomization. N= number of participants analyzed in all categories|||participants|||Number
2817334|NCT00402168|Secondary|Ridit Score at Month 12 - All Randomized Participants|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Month 12|All randomized participants with MTSOSD-59R data were analyzed.|||Ridit score|||Number
2817344|NCT00402168|Secondary|Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.|At 6 and 12 months post randomization|All participants who were randomized were summarized.|||percentage of participants|||Number
2827879|NCT00319982|Secondary|Impact of Diltiazem on Heart Rate|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits||||beats/minute||Standard Error|Mean
2817335|NCT00402168|Secondary|Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants|"SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.~All domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life."|Baseline (screening) to Month 12|Randomized participants with available questionnaires were analyzed.|||units on a scale||Standard Error|Mean
2817336|NCT00402168|Secondary|Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.|Baseline, Month 12|All randomized participants who completed the questionnaire at baseline and at Month 12.|||units on a scale||Standard Error|Mean
2817337|NCT00402168|Secondary|Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First Dose (Day 1) to Month 12|All randomized participants who received at least 1 dose of study drug were summarized.|||participants|||Number
2817338|NCT00402168|Secondary|Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants|Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.|Baseline to Month 6 and Month 12 Post Randomization|All randomized participants with baseline and laboratory value at specific time point were summarized.|||mg/dL||Standard Deviation|Mean
2817339|NCT00402168|Secondary|Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies|Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).|Month 6 and Month 12 Post Randomization|Participants who had at least one test result or finding were summarized. n=number of participants analyzed at each specific time point.|||participants|||Number
2817340|NCT00402168|Secondary|Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Month 12 post randomization|Participants without pre-randomization diabetes.|||percentage of participants||95% Confidence Interval|Number
2817341|NCT00402168|Secondary|Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12|Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.|12 Months post randomization|All participants who were randomized were analyzed.|||percentage of participants||95% Confidence Interval|Number
2817342|NCT00402168|Primary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.|Baseline to 12 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.|||mL/min/1.73 m^2||Standard Deviation|Mean
2817343|NCT00402168|Secondary|Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants|Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.|Month 12|Participants who were randomized and received at least one dose of any study drug.|||participants|||Number
2825118|NCT00343863|Secondary|Number of Participants That Had Emesis Within 48 Hours of Chemotherapy|Count of patients that had emesis within 48 hours of chemotherapy|Up to 48 hours of chemotherapy||||Participants|||Count of Participants
2817345|NCT00402168|Secondary|Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants|AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.|At 6 and 12 months post randomization|ITT population: All randomized participants were summarized. N=number analyzed for Months 6 and 12|||participants|||Number
2817346|NCT00402168|Secondary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.|Baseline to 6 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.|||mL/min/1.73 m^2||Standard Deviation|Mean
2817347|NCT00402103|Secondary|Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.|||Percentage of patients|||Number
2817348|NCT00402103|Secondary|Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.|||Percentage of patients|||Number
2817349|NCT00402103|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points||Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54|Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.|||mm Hg||Standard Deviation|Mean
2817350|NCT00402103|Primary|Overall Percentage of Patients With Adverse Events||52 weeks|Treated Population|||Percentage of Participants|||Number
2817351|NCT00402051|Secondary|Pharmacology Toxicities|Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.|Every 21-day cycle for up to 6 cycles|Full Analysis Set: All patients randomized who received at least one dose of study drug|||participants|||Number
2817352|NCT00402051|Secondary|Time to Treatment Failure (TTF)|Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first|Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug|||months||95% Confidence Interval|Median
2817353|NCT00402051|Secondary|Number of Participants With Tumor Response (as Basis for Response Rate)|"Best overall response was evaluated using RECIST Criteria which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage."|Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression|Full Analysis Set: All patients randomized who received at least one dose of study drug|||participants|||Number
2817354|NCT00402051|Secondary|Overall Survival|Defined as the time from randomization to the date of death from any cause.|Randomization to date of death from any cause (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug|||months||95% Confidence Interval|Median
2817355|NCT00402051|Primary|Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)|For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.|Randomization to Month 6|Full Analysis Set: All patients randomized who received at least one dose of study drug|||percentage|||Number
2817370|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Total Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2825119|NCT00343863|Secondary|Number of Days With Emetic Episodes and Rescue Medicines||Up to 3 months||||days||Full Range|Median
2817356|NCT00402025|Secondary|Change From Baseline in Pain Intensity|"Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing no pain and the rightmost end (10 cm) representing worst pain. The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level."|Baseline and Weeks 3 and 6|ITT population with available VAS data; this assessment was added in the third protocol amendment and change from baseline could only be assessed for participants in cohort 3.|||cm||Standard Deviation|Mean
2817357|NCT00402025|Primary|Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies|Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).|Week 0 (Day 1, predose) and Week 3|ITT population with available antibody results (indicated by N)|||participants|||Number
2817358|NCT00402025|Primary|Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine|Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.|Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.|ITT population|||participants|||Number
2817359|NCT00402025|Secondary|Number of Participants With Overall Objective Response|"Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR).~CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met.~PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met."|Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population|||participants|||Number
2817360|NCT00402025|Secondary|Change From Baseline in Sum of Longest Diameters of Injected Tumors|Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.|Baseline and Week 6, 12 and 18|"ITT population with available data at each time point (indicated by N)."|||mm||Standard Deviation|Mean
2817361|NCT00402025|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.|From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population|||participants|||Number
2817362|NCT00401973|Secondary|Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks|To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.|Baseline to endpoint (22 weeks)|N=Pairs of Observations for the combined treatment groups.|||correlation|||Number
2817363|NCT00401973|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.|||units on a scale||Standard Deviation|Mean
2817364|NCT00401973|Secondary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.|||units on a scale||Standard Deviation|Mean
2817365|NCT00401973|Secondary|Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.|||units on a scale||Standard Deviation|Mean
2817366|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Hemoglobin A1c||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||percent hemoglobin A1c||Standard Deviation|Mean
2817367|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Glucose||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2817368|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2817369|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol||Baseline to endpoint (22 weeks)|Number of randomized participants with a baseline and at least one post-baseline measurement. Last post-baseline measurement carried forward.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2817381|NCT00401843|Primary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 5 years|The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.|||participants|||Number
2817382|NCT00401843|Secondary|Overall Survival|Overall survival was defined as the interval between the first administration of study agent or randomization (Part 2) and the participant's death from any cause. For participants with unknown survival status as of the data cut-off date, overall survival was censored at the last date known to be alive.|up to 5 years|ITT population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.|||days||95% Confidence Interval|Median
2817383|NCT00401843|Secondary|Percentage of Participants With Confirmed Complete Response (CR Rate)|CR rate was defined as the percentage of participants who achieved a confirmed CR before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.|||percentage of participants|||Number
2817384|NCT00401843|Secondary|Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate)|Overall response rate was defined as best response (CR/PR confirmed) for a participant recorded from first administration of study agent or randomization (Part 2) until disease progression/recurrence and before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. PR: Greater than or equal to (>=) 50% reduction in level of serum M-protein, maintained for minimum of 6 weeks. Reduction in 24 hour urinary light chain excretion either by >= 90% or to < 200 mg, maintained for minimum of 6 weeks; >= 50% reduction in size of soft tissue plasmacytomas; No increase in size/number of lytic bone lesions.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.|||percentage of participants|||Number
2817385|NCT00401843|Primary|Progression-free Survival|Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response [CR]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune reconstitution; Greater than or equal to (>=) 5 percent (%) plasma cells either in a bone marrow aspirate or on trephine bone biopsy; Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression); Development of hypercalcemia not attributable to any other cause.|Randomization until disease progression or death, which ever occured first (maximum up to 5 years)|Intent-to-treat (ITT) population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.|||days||95% Confidence Interval|Median
2817386|NCT00401830|Secondary|Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.|||ug/ML||Standard Deviation|Mean
2817387|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
2817388|NCT00401830|Secondary|Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase|Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.|||Percentage of patients|||Number
2817389|NCT00401830|Secondary|Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.|||Percentage of patients|||Number
2817430|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Participants|||Number
2817390|NCT00401830|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.|||Score on a scale||Standard Deviation|Mean
2817391|NCT00401830|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.|||Patients|||Number
2817392|NCT00401830|Secondary|Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2817393|NCT00401830|Secondary|Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2817394|NCT00401830|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2817395|NCT00401830|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2817396|NCT00401830|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
2817397|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.|||Score on a scale||Standard Deviation|Mean
2817398|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.|||Score on a scale||Standard Deviation|Mean
2817399|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.|||Score on a scale||Standard Deviation|Mean
2817400|NCT00401817|Secondary|Overall Survival|"The percentage of patients who have survived at the three year time point.~The 3-year OS rate was estimated based on the Kaplan-Meier analysis."|3 years|Evaluable Patients|||percentage of patients||95% Confidence Interval|Number
2817401|NCT00401817|Secondary|Progression-Free Survival|"The percentage of patients who have not progressed at the three year time point.~The 3-year PFS rate was estimated based on the Kaplan-Meier analysis."|3 years|Evaluable patients|||percentage of patients||95% Confidence Interval|Number
2817402|NCT00401817|Secondary|Overall Response Rate|"Overall Response Rate measured using Kaplan-Meier survival analysis~Response criteria were those reported by Cheson et al. (1999)"|38 Months (min 33 months, max 62 months)|Evaluable patients|||percentage of participants||95% Confidence Interval|Number
2817403|NCT00401817|Primary|Number of Participants With Toxicity|Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|38 months||||participants|||Number
2817404|NCT00401778|Secondary|Duration of Hospital Stay Following Surgery.||6 months||||days||Full Range|Median
2817405|NCT00401778|Secondary|Safety and Tolerability of RAD001 as Pre-operative Therapy.||6 months|||||||
2817407|NCT00401778|Primary|Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).|Changes in the expression of key signaling proteins in the mTOR/phosphatidylinositol 3-kinase (PI3K) pathway were determined by immunohistochemistry using previously published protocols and manufacturers' recommendations for antigen retrieval and antibody dilution along with positive and negative controls. Two investigators assessed protein expression jointly by light microscopy. The degree of expression was assessed by intensity (0, 1+, 2+, 3+) and percentage of cell staining in line with published algorithm. A derivative score (immunoscore) ranging between 0 and 300 was calculated as the product of intensity and percent cell staining.|6 months||||% change in immunoscore||Standard Deviation|Mean
2817408|NCT00401778|Primary|Clinical Response as Assessed Metabolically by Changes in Positron Emission Tomography (PET) Scan Between Baseline and Immediately Prior to Surgery.|All patients had baseline imaging in a fasted state with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18FDG)-PET scan and a repeat scan at 3 to 4 weeks later using routine clinical protocol for patient preparation, radiotracer administration and data acquisition. The repeat imaging occurred no longer than 24 hours before surgical resection.|Day 21||||percentage of patients|||Number
2817409|NCT00401752|Secondary|The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.|4 & 8 weeks||||Percentage of participants|||Number
2817410|NCT00401752|Secondary|The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.|4 and 8 week||||Percentage of participants|||Number
2817411|NCT00401752|Secondary|Percentage of Participants With the Occurance of Any Adverse Event.|Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.|8 weeks|Patients included in safety population|||Percentage of participants|||Number
2817412|NCT00401752|Secondary|The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.|week 4 and week 8||||Percentage of participants|||Number
2817413|NCT00401752|Secondary|The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.|8 weeks||||Percentage of participants|||Number
2817414|NCT00401752|Primary|The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.|"Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.~(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent)."|4 weeks||||Percentage of participants|||Number
2817415|NCT00401726|Secondary|Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. Data not available for one participant.|||patients|||Number
2817416|NCT00401726|Secondary|Change in Sheehan Disability Scale Score From Baseline to 16 Weeks|The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
2817417|NCT00401726|Secondary|Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks|IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
2817418|NCT00401726|Secondary|Number of Patients Compliant With Therapy|"Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of Never miss or Sometimes miss."|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||participants|||Number
2820168|NCT00383071|Primary|Safety of H5N1 Vaccine as Measured by Adverse Events|The number of subjects experiencing adverse events after receiving H5N1 vaccine|Day 28, 56, 84|Primary outcome measure was safety, so below listed numbers are safety population used in AE list.|||participants|||Number
2817419|NCT00401726|Secondary|Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks|WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
2817420|NCT00401726|Secondary|Patient Global Impression of Improvement (PGI-I) Score|PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
2817421|NCT00401726|Secondary|Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||units on scale||Standard Error|Mean
2817422|NCT00401726|Primary|"Number of Patients Responding Very Satisfied on Satisfaction With Depression Care Scale (SDCS)"|"Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). Very satisfied was defined as a score of greater than or equal to 8."|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.|||participants|||Number
2817423|NCT00401622|Primary|Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.||From baseline to 52 wks|The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups|||Percentage||Standard Error|Least Squares Mean
2817424|NCT00401622|Secondary|Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.||52 wks||||mg/dL||Standard Deviation|Mean
2817425|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.|||Units on a scale||Standard Deviation|Mean
2817426|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.|||Units on a scale||Standard Deviation|Mean
2817427|NCT00401544|Secondary|Time to Hematopoietic Response, by IV Iron Usage|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Weeks||95% Confidence Interval|Median
2817428|NCT00401544|Secondary|Time to Hematopoietic Response, by Darbepoetin Alfa Dose|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Weeks||95% Confidence Interval|Median
2817429|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by IV Iron Usage|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.|||Participants|||Number
2825120|NCT00343863|Secondary|Count of Patients Achieving Complete Response||At 24-120 hours after weekly intravenous doxorubicin||||Participants|||Count of Participants
2817431|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study|Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 5 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.|||Participants|||Number
2817432|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.|||Participants|||Number
2817433|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.|||Participants|||Number
2817434|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by IV Iron Usage|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.|||g/dL||Standard Deviation|Mean
2817435|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.|||g/dL||Standard Deviation|Mean
2817436|NCT00401544|Secondary|Time to Achieve the Target Hemoglobin Level, by IV Iron Usage|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Weeks||95% Confidence Interval|Median
2817437|NCT00401544|Secondary|Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Weeks||95% Confidence Interval|Median
2817438|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Participants|||Number
2817439|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.|||Participants|||Number
2817440|NCT00401531|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|"Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.~Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.|||Participants|||Number
2817441|NCT00401531|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.|Day 150 post-dose 1|Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2817442|NCT00401531|Secondary|Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.|Day 150 post-dose 1|Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.|||Participants|||Number
2817443|NCT00401531|Secondary|Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil|Day 150 post-dose 1|Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.|||Participants|||Number
2817444|NCT00401531|Secondary|Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.|||Participants|||Number
2817445|NCT00401531|Primary|Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.|||Participants|||Number
2817446|NCT00401414|Secondary|Proportion of Patients With Serious Adverse Clinical Events.|Defined as an INR>4.0, use of vitamin K, major bleeding events (as defined by the Thrombolysis in Myocardial Infarction [TIMI] criteria), thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause).|90 Days||||participants|||Number
2817447|NCT00401414|Secondary|Time to Stable Anticoagulation (in Days).|Defined as two consecutive INRs within the therapeutic range >7 days apart and with no dose change during this time.|90 Days||||Days||Standard Deviation|Mean
2817448|NCT00401414|Secondary|Per-patient Percentage of INRs Out of the Therapeutic Range|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days||||percentage of INRs out of range||Standard Deviation|Mean
2817449|NCT00401414|Secondary|Time to the First Therapeutic INR.|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days||||Days||Standard Deviation|Mean
2817450|NCT00401414|Primary|Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al).|"Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection).~The international normalized ratio (INR) is one way of presenting prothrombin time test results for people taking the blood-thinning medication warfarin. The INR formula adjusts for variation in laboratory testing methods so that test results can be comparable."|90 Days||||percentage of time||Standard Deviation|Mean
2817451|NCT00401401|Secondary|Best Overall Tumor Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years||||Participants|||Number
2817452|NCT00401401|Secondary|Time to Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|Number of months between date of first infusion and date of best response|||months||Full Range|Median
2817453|NCT00401401|Secondary|Overall Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years||||Participants|||Number
2817454|NCT00401401|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.|Overall Study||||participants|||Number
2817455|NCT00401375|Secondary|Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)|CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.|0 and 24 hours|mITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2817456|NCT00401375|Secondary|Time to Discharge Order Written From the End of Surgery|The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate.|Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10|mITT population included all randomized participants who received at least 1 dose of study drug.|||days||Standard Error|Mean
2817468|NCT00401245|Other Pre-specified|Mean Age of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Years||Standard Deviation|Mean
2825121|NCT00343863|Primary|Count of Patients Achieving a Complete Response||At 0-24 hours after weekly intravenous doxorubin||||Participants|||Count of Participants
2817457|NCT00401375|Secondary|Time to Discharge Eligibility|Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as both tolerance of solid food and at least one bowel movement. Participants were considered to have tolerated solid food when they have eaten greater than or equal to (≥) 50 percent (%), of the first of two successive solid food meals (based on the judgement of the investigator or designee), without vomiting or nausea. Participants readmitted to the hospital with a diagnosis of POI within 7 days of discharge were considered treatment failures. Analysis was performed by Kaplan-Meier estimate.|Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10|mITT population included all randomized participants who received at least 1 dose of study drug.|||days||Standard Error|Mean
2817458|NCT00401375|Primary|Time to First Bowel Movement|Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.|Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10|mITT population included all randomized participants who received at least 1 dose of study drug.|||days||Standard Error|Mean
2817459|NCT00401258|Secondary|Sheehan Disability Scale|"The Sheehan Disability Scale is a brief, 5-item self-report tool that assess functional impairment in work/school, social life, and family life. Scores range from 0-10 in each subset, with 0 being unimpaired and 10 being highly impaired.~The primary analysis of this scale was an endpoint analysis of the change from baseline."|At baseline and week 12||||units on a scale||95% Confidence Interval|Mean
2817460|NCT00401258|Secondary|Irritable Bowel Syndrome-Quality of Life Scale|"The Irritable Bowel Syndrome (IBS) Quality of Life Scale is a self-report quality of life measure specific to Irritable Bowel Syndrome that can be used to assess the impact of IBS and its treatment. There are 34 items summed and averaged for a total score between 0-100, with higher scores indicating better IBS specific quality of life.~Each item measures one of eight sub scales - dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships - and is rated on a scale of 1-5 indicating how much the subject agrees with the statement (1 is no agreement, 5 is extreme agreement).~The primary analysis of this scale was an endpoint analysis of the change from baseline."|At baseline and week 12||||units on a scale||95% Confidence Interval|Mean
2817461|NCT00401258|Secondary|Hamilton Anxiety Rating Scale|"The Hamilton Anxiety Rating Scale is a clinician-administered scale designed to assess the severity of symptoms of anxiety. There are 14 items, scored on a scale of 0 (not present) to 4 (severe). The total score range is 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.~The primary analysis of this scale was an endpoint analysis of the change from baseline."|At baseline and week 12||||units on a scale||95% Confidence Interval|Mean
2817462|NCT00401258|Secondary|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale is a clinician-rated scale consisting of 17 questions designed to assess depressive symptoms. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression. 52 is the maximum score.|At first visit only||||units on a scale||Standard Deviation|Mean
2817463|NCT00401258|Secondary|Clinical Global Impression Scale|"The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12."|At each visit||||units on a scale||95% Confidence Interval|Mean
2817464|NCT00401258|Secondary|Short Form McGill Pain Questionnaire|"The Short Form McGill Pain Questionnaire is a self-administered questionnaire that measures pain intensity experienced by the patient. Scores on 15 descriptors are rated on an intensity scale of 0-3 (with 0 being no pain to 3 being severe pain), and has an overall score of between 0-45, with 0 being no pain and 45 being worst possible pain.~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12."|At each visit||||units on a scale||95% Confidence Interval|Mean
2817465|NCT00401258|Secondary|Brief Pain Inventory|"The Brief Pain Inventory is a self-administered questionnaire used to evaluate the severity of a patient's pain and its interference with their life.~Four items measure pain severity on a scale of 0-10, with 0 being absence of pain and 10 being severe pain. Seven items measure pain interference on a scale of 0-10, with 0 being absence of interference and 10 being severe interference.~The sub scale of both sub scores ranges 0-40, with 0 indicating no pain/interference and 40 indicating severe pain/interference.~The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12."|At each visit||||units on a scale||95% Confidence Interval|Mean
2817466|NCT00401258|Primary|Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).|Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.|baseline and week 12||||Units on a scale||95% Confidence Interval|Mean
2817467|NCT00401245|Other Pre-specified|Gender of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Participants|||Number
2817469|NCT00401245|Secondary|Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16|MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.|Baseline, Week 4, Week 8, Week 12 and Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Units on a scale||Standard Deviation|Mean
2817470|NCT00401245|Secondary|Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score|MS-TSQ is a questionnaire assessing participants' degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).|Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
2817471|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability at the End of Tapering|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Participants|||Number
2817472|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants' response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 1 and Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Participants|||Number
2817473|NCT00401245|Secondary|Number of Participants With Each DESS One Week After End of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Participants|||Number
2817474|NCT00401245|Secondary|Number of Participants With Each DESS at the End of Second Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Participants|||Number
2817475|NCT00401245|Secondary|Number of Participants With Each DESS at the End of First Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Participants|||Number
2817476|NCT00401245|Secondary|Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.|||Percentage of participants|||Number
2817477|NCT00401245|Secondary|Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.|||Participants|||Number
2817478|NCT00401245|Primary|DESS Total Score at 1 Week After the End of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
2817503|NCT00400946|Primary|Asparaginase-Related Toxicity Rate|Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on CTCAEv3.|30-week post-induction asparaginase treatment period|The analysis dataset is comprised of all randomized patients.|||percentage of participants||95% Confidence Interval|Number
2817479|NCT00401245|Primary|DESS Total Score at End of Second Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
2817480|NCT00401245|Primary|Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.|||Units on a scale||Standard Deviation|Mean
2817481|NCT00401245|Primary|Number of Participants With Nausea During the First 2 Weeks of Treatment|Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.|||Participants|||Number
2817482|NCT00401193|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Baseline over 3 mentrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||percentage of participants|||Number
2817483|NCT00401193|Secondary|Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
2817484|NCT00401193|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
2817485|NCT00401193|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 3 menstrual cycles|modified intent to treat population|||mL||Standard Deviation|Least Squares Mean
2817486|NCT00401102|Secondary|Multidimensional Anxiety Scale for Children||recently|||||||
2817487|NCT00401102|Secondary|Beck Depression Inventory||2 weeks|||||||
2817488|NCT00401102|Primary|Self-injury Monitoring Card||1 month|||||||
2817489|NCT00401102|Primary|Self-Injurious Thoughts and Behaviors Interview||8 weeks|Data for all subjects who completed the study was examined - however because this was a small pilot study and only 5 subjects completed treatment, no statistical tests were completed.|||episodes of self-injury past month||Standard Deviation|Mean
2817490|NCT00401102|Primary|CDRS||1 week|||||||
2817491|NCT00401102|Primary|C-GAS||1 month|||||||
2817492|NCT00401102|Primary|CGI||1 week|||||||
2817493|NCT00400985|Primary|Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.||34 days post device implant to 6 months||||hospitalization|||Number
2817494|NCT00400946|Secondary|5-year Disease-Free Survival by CNS Directed Treatment Group|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of patients who achieved an induction complete remission with an evaluable sample at diagnosis for analysis of CNS-directed therapy .|||probability||95% Confidence Interval|Number
2817504|NCT00400881|Secondary|Duration of Mechanical Ventilation|Duration in days from day of intubation to day of extubation.|days|Analysis per protocol. All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.|||days||Standard Deviation|Mean
2817505|NCT00400881|Primary|Duration of Weaning Time|Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.|days|All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.|||days||Standard Deviation|Mean
2817495|NCT00400946|Secondary|5-Year Disease-Free Survival by Bone Marrow Day 18 Status|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of patients who achieved an induction complete remission with an evaluable sample at day 18 (optional submission) for analysis of marrow morphology.|||probability||95% Confidence Interval|Number
2817496|NCT00400946|Secondary|5-Year Disease-Free Survival by MRD Day 32 Status|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of B cell ALL patients who achieved an induction complete remission with an evaluable sample at day 32 for analysis of MRD.|||probability||95% Confidence Interval|Number
2817497|NCT00400946|Secondary|Induction Therapeutic Nadir Serum Asparaginase Activity Rate|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint.|Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction assessment timepoints.|||percentage of participants|||Number
2817498|NCT00400946|Secondary|Induction Serum Asparaginase Activity Level|Serum asparaginase activity (NSAA) levels were estimated based on established methods.|Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction assessment timepoints.|||IU/mL||Inter-Quartile Range|Median
2817499|NCT00400946|Secondary|Induction Infection Toxicity Rate|Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy.|Assessed daily during remission induction days 4-32.|The analysis dataset is comprised of eligible and treated patients. This excludes the 6 enrolled but ineligible patients. Rates in this overall study cohort will be compared against historical controls (in particular patients treated with a more intensive induction regimen).|||percentage of participants||95% Confidence Interval|Number
2817500|NCT00400946|Secondary|Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy.|Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.|The analysis dataset is comprised of all randomized patients who consented to research studies with a one post-induction evaluable sample for analysis of serum asparaginase activity.|||percentage of participants||95% Confidence Interval|Number
2817501|NCT00400946|Secondary|Post-Induction Nadir Serum Asparaginase Activity Level|Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods.|Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.|The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective post-induction assessment timepoints.|||IU/mL||Standard Deviation|Mean
2817502|NCT00400946|Secondary|5-Year Disease-Free Survival|Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.|Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.|The analysis dataset is comprised of all randomized patients.|||probability||95% Confidence Interval|Number
2817508|NCT00400829|Primary|Objective Response Rate (CR or PR) According to RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Tumor measurements repeated every 6 weeks||||percentage of patients responding|||Number
2817509|NCT00400803|Secondary|Time to Best Response|Time to best response is defined as the time from the start of treatment until first documented evidence of tumor response (30% decrease or complete disappearance of tumor). For subjects who do not show a tumor response, the time will be censored at the time of last contact.|From Enrollment to First Tumor Response||||Days||Full Range|Median
2817510|NCT00400803|Secondary|Overall Survival Time|Overall survival is defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|Baseline to Death||||Months||Standard Error|Mean
2817511|NCT00400803|Secondary|Duration of Response|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response(30% decrease or complete disappearance of tumor) until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment.|From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months||||Days||Full Range|Median
2817512|NCT00400803|Secondary|Best Overall Response by Cycle|Number of patients and their best response recorded from the state of treatment until disease progression. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response-disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|After Cycle 4, Cycle 6 and Cycle 7 of Therapy|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment. 5 patients = missing data.|||Participants|||Number
2817513|NCT00400803|Primary|Time to Progression|Time to progression (progression free survival)is defined as the time from the start of treatment until first documented sign of disease progression or death due to any cause. For subjects who do not progress, time to progression will be censored at the time of last tumor assessment.|From Enrollment Through 2 Years||||Months||Standard Error|Mean
2817514|NCT00400764|Primary|Mean Serum Concentration of Dulanermin|The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA).|Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1.|Safety-evaluable population|||µg/ml||Standard Deviation|Mean
2817515|NCT00400764|Primary|Number of Participants With a Clinically Significant Laboratory Abnormality|Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms).|Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug.|||participants|||Number
2817516|NCT00400764|Primary|Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit|Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||degrees Celsius||Standard Deviation|Mean
2817517|NCT00400764|Secondary|Phase II: Duration of Response as Assessed by the Investigator|"An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study.~Kaplan−Meier methods were used to estimate median, percentiles, and range of duration of response."|From Baseline through Study Termination (up to approximately 33 months)|Safety-evaluable patients with an objective response determined by the Investigator.|||months||95% Confidence Interval|Median
2817518|NCT00400764|Secondary|Phase II: Objective Response as Assessed by the Investigator|Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders.|From Baseline through Study Termination (up to approximately 33 months)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||participants|||Number
2817519|NCT00400764|Secondary|Phase II: Overall Survival|Median overall survival could not be estimated because of the low number of deaths at the time of study termination.|From Baseline through Study Termination (up to approximately 33 months)||||months||95% Confidence Interval|Median
2817520|NCT00400764|Secondary|Phase II: Progression Free Survival|Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan−Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment.|From Baseline through Study Termination (up to approximately 33 months)|Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment|||months||95% Confidence Interval|Median
2817602|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817521|NCT00400764|Primary|Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit|Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||beats/minute||Standard Deviation|Mean
2817522|NCT00400764|Primary|Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit|Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||mmHg||Standard Deviation|Mean
2817523|NCT00400764|Primary|Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)|"Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment.~Patients without a post-baseline tumor assessment were considered non-responders."|From Baseline through Study Termination (up to approximately 33 months)|The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF.|||participants|||Number
2817524|NCT00400764|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity Grade|Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE).|From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.|||participants|||Number
2817525|NCT00400764|Primary|Phase Ib: Number of Participants With a Dose-limiting Toxicity|A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).|The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).|The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window.|||participants|||Number
2817526|NCT00400712|Primary|Subjective Index of Physical Integration (Subscale of SIPSO)|see 'Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing|||points on a scale||Standard Deviation|Mean
2817527|NCT00400712|Primary|Subjective Index of Social Integration (Subscale of SIPSO)|see Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing|||points on a scale||Standard Deviation|Mean
2817528|NCT00400712|Secondary|Health-related Quality of Life - Mental|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.|baseline and one year|those enrolled at 1 year (primary endpoint)|||points||Standard Deviation|Mean
2817529|NCT00400712|Secondary|Health-related Quality of Life - Physical|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.|baseline and one year|those enrolled at primary endpoint (one year)|||points||Standard Deviation|Mean
2817530|NCT00400712|Secondary|Physical Capacity|6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.|baseline and 12 months|all those enrolled at primary endpoint - 1 year|||meters||Standard Deviation|Mean
2817531|NCT00400712|Secondary|Mobility Function|Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)|baseline and 1 year|those still enrolled at primary endpoint (one year)|||seconds||Standard Deviation|Mean
2817532|NCT00400712|Primary|Subjective Index of Physical and Social Outcome (SIPSO)|The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.|baseline and 1 year|those who completed 1 year testing|||scores on a scale||Standard Deviation|Mean
2817533|NCT00400686|Primary|Number of Patients With an at Least 2gm/dL Increase in Hgb||Baseline to Day 28||||participants|||Number
2817534|NCT00400686|Primary|Number of Patients With an at Least 1gm/dL Increase in Hgb||Baseline to Day 28||||participants|||Number
2817536|NCT00400634|Other Pre-specified|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 18 Month Visit|Subjects who completed the 12-month double-blind posttreatment period of the study continued to undergo double-blind assessments every 3 months until the last subject had completed the end-of-study visit at month 12. The LOCF method was used to impute data at month 18 for the subjects who had blinded data through month 15.|||units on a scale||Standard Error|Least Squares Mean
2817537|NCT00400634|Primary|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 12 Month Visit|Subjects who completed the end-of-study visit at month 12 and had no important protocol deviations that potentially could have affected the efficacy assessment of the study drug.|||units on a scale||95% Confidence Interval|Least Squares Mean
2817538|NCT00400569|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.|4 years, 7 months|All Participants|||participants|||Number
2817539|NCT00400569|Secondary|Participants' Overall Survival (OS)|The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.|From On Treatment to Off Study - average of 6 months|All participants who completed the study|||months||95% Confidence Interval|Median
2817540|NCT00400569|Secondary|Participants' Progression Free Survival (PFS)|Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants who completed the study|||months||95% Confidence Interval|Median
2817541|NCT00400569|Primary|Number of Participants With Overall Response (OR)|Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants assessable for response|||participants|||Number
2817542|NCT00400517|Primary|Time to Clinical Progression|Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.|32 months||||Participants|||Count of Participants
2817543|NCT00400517|Primary|Prostate-specific Antigen Response|Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.|8 weeks||||Participants|||Count of Participants
2817544|NCT00400517|Primary|Proportion of Patients With Negative Surgical Margins|Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.|8 Weeks||||Participants|||Count of Participants
2817545|NCT00400517|Primary|Proportion of Patients P0 at Surgery|Pathologic Complete Response is defined as complete eradication of tumor.|8 weeks||||Participants|||Count of Participants
2817546|NCT00400439|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)||Baseline and Week 24 (Week 48 from start of NC19453)||||mg/dL||Standard Error|Least Squares Mean
2817547|NCT00400439|Primary|Percent Change From Baseline in HDL-C||Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))||||Percentage Change of HDL-C||Standard Error|Least Squares Mean
2817548|NCT00400400|Secondary|Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores|The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction.|Baseline, Day 30|"Participants from the Intention-to-treat (ITT) population consisting of all randomized participants who received at least one dose of study drug for whom data was available for analysis. n in each of the categories is the number of participants with data available."|||Score on a scale||Standard Deviation|Mean
2817549|NCT00400400|Secondary|Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment|The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales.|Baseline to Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.|||Score on a scale||Standard Deviation|Mean
2817550|NCT00400400|Secondary|Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score|This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.|||change in score on a scale||Standard Deviation|Mean
2817551|NCT00400400|Secondary|Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment|The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia).|30 days|Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2817552|NCT00400400|Secondary|Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score|The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms.|Baseline, Day 30|"Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. n in each of the categories is the number of participants with data."|||Score on a scale||Standard Deviation|Mean
2817553|NCT00400400|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)|"TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy.~BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria."|30 days|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2817554|NCT00400400|Primary|The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy|Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.|||Participants|||Number
2817555|NCT00400205|Secondary|Tumor Change by Baseline Acetylated Tubulin Expression Score|"Percent change in TNM stage of tumors after three cycles of study treatment was assessed to see if baseline acetylated tubulin (AT) expression predicts treatment success. Decreasing tumor stage change (a negative number) indicates that the tumor is responding to treatment while an increase means that the severity of the tumor is not decreasing. Immunohistochemistry (IHC) analysis of AT expression was performed in formalin-fixed, paraffin-embedded, pre-treatment tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.~Data presented are adopted from Saba, NF, et. al. Acetylated Tubulin (AT) as a Prognostic Marker in Squamous Cell Carcinoma of the Head and Neck. Head and Neck Pathology (2014) 8:66-72."|Baseline, After 3 cycles of study treatment|Participants who completed the study are included in this analysis.|||percentage of tumor stage change||Standard Deviation|Mean
2817556|NCT00400205|Primary|Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)|Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].|every 3 months||||participants|||Number
2817557|NCT00400179|Primary|Median Survival|Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.|The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).||||Months||95% Confidence Interval|Median
2817558|NCT00400179|Secondary|Time to Treatment Failure (TTF)|The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.|From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.||||Months||95% Confidence Interval|Median
2817559|NCT00400179|Secondary|Progression-free Survival (PFS)|The time from randomization to date of first documented PD or date of death, whichever occurred first.|From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.||||Months||95% Confidence Interval|Median
2817560|NCT00400179|Secondary|Duration of Response (DR)|Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient was randomized).||||Months||95% Confidence Interval|Median
2817561|NCT00400179|Secondary|Overall Response Rate (ORR)|The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient randomized).||||Percentage of patients in each group||95% Confidence Interval|Number
2817562|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−6, ss|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
2825122|NCT00343785|Secondary|Overall Survival|Number of patients alive at one year|From the time of enrollment until death from any cause up to one year|All Patients|||Participants|||Count of Participants
2817563|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0−6,ss|Before drug administration to 6 hours after drug administration on Day 26|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
2817564|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−2,ss.|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
2817565|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||μg||Geometric Coefficient of Variation|Geometric Mean
2817566|NCT00400153|Secondary|Noncompartmental Parameters of Albuterol at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2817567|NCT00400153|Secondary|Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2817568|NCT00400153|Secondary|Rating of Action of Turning Clear Base of Respimat|Frequency of patients due to rating of action of turning clear base of Respimat|12 weeks|Treated set (US patients)|||participants|||Number
2817569|NCT00400153|Secondary|Device Preference (Respimat or MDI)|Frequency of patients due to device preference|12 weeks|Treated set (US patients)|||participants|||Number
2817570|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817571|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817572|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817573|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817574|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817575|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817576|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817577|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817578|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817579|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)|||units on a scale||Standard Error|Mean
2817580|NCT00400153|Secondary|Frequency Distribution of Satisfaction Rating With Inhaler Attributes||12 weeks|Treated set (US patients)|||participants|||Number
2817581|NCT00400153|Secondary|COPD Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set|||Percentage of patients|||Number
2817582|NCT00400153|Secondary|COPD Exacerbation Rate During the On-treatment Period|Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set|||Proportion of patients|||Number
2817583|NCT00400153|Secondary|Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set|||Percentage of patients|||Number
2817584|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 85|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 85|Treated Set|||units on a scale||Standard Error|Least Squares Mean
2817585|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 57|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 57|Treated Set|||units on a scale||Standard Error|Least Squares Mean
2817586|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 29|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 29|Treated Set|||units on a scale||Standard Error|Least Squares Mean
2817587|NCT00400153|Secondary|Trough Peak Expiratory Flow Rate (PEFR)|The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication|Full Analysis Set for Diary Data|||liters/min||Standard Error|Least Squares Mean
2817588|NCT00400153|Secondary|Daytime Symptom Score|"The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).~Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||units on a scale||Standard Error|Least Squares Mean
2817589|NCT00400153|Secondary|Night-time Symptom Score|"The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).~Night−time COPD symptoms: 0=none 1=some − slept well 2=woke once 3=woke several times 4=woke most of night"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||units on a scale||Standard Error|Least Squares Mean
2817590|NCT00400153|Secondary|Daytime Rescue Medication Use|The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||puffs||Standard Error|Least Squares Mean
2817591|NCT00400153|Secondary|Night-time Rescue Medication Use|The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data|||puffs||Standard Error|Least Squares Mean
2817592|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 85|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85|During the 6-hour pulmonary function testing after drug administration on Day 85|Treated Set|||patients|||Number
2817593|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 57|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57|During the 6-hour pulmonary function testing after drug administration on Day 57|Treated Set|||patients|||Number
2817594|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 29|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29|During the 6-hour pulmonary function testing after drug administration on Day 29|Treated Set|||patients|||Number
2817595|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 1|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1|During the 6-hour pulmonary function testing after drug administration on Day 1|Treated Set|||patients|||Number
2817596|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817597|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817598|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817603|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817604|NCT00400153|Secondary|FVC AUC4-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817605|NCT00400153|Secondary|FVC AUC4-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817606|NCT00400153|Secondary|FVC AUC4-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817607|NCT00400153|Secondary|FVC AUC4-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817608|NCT00400153|Secondary|FVC AUC0-4 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817609|NCT00400153|Secondary|FVC AUC0-4 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817610|NCT00400153|Secondary|FVC AUC0-4 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817611|NCT00400153|Secondary|FVC AUC0-4 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817612|NCT00400153|Secondary|FVC AUC0-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817613|NCT00400153|Secondary|FVC AUC0-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817614|NCT00400153|Secondary|FVC AUC0-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817615|NCT00400153|Secondary|FVC AUC0-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817616|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 85|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85|Within the 6-hour post-treatment observation period at Day 85|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817617|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 57|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57|Within the 6-hour post-treatment observation period at Day 57|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817618|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 29|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29|Within the 6-hour post-treatment observation period at Day 29|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817619|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 1|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1|Within the 6-hour post-treatment observation period at Day 1|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817620|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 85|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85|During the 6-hour observation period after drug administration at Day 85|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817621|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 57|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57|During the 6-hour observation period after drug administration at Day 57|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817676|NCT00399542|Secondary|Month 3 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2817622|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 29|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29|During the 6-hour observation period after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817623|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 1|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1|During the 6-hour observation period after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817624|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 85|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817625|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 57|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817626|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 29|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817627|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 1|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data|||Minutes||Inter-Quartile Range|Median
2817628|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817629|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817630|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817631|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817632|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817633|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817634|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817635|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817636|NCT00400153|Secondary|FEV1 AUC4-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817637|NCT00400153|Secondary|FEV1 AUC4-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817638|NCT00400153|Secondary|FEV1 AUC4-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817639|NCT00400153|Secondary|FEV1 AUC0-4 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817640|NCT00400153|Secondary|FEV1 AUC0-4 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2825123|NCT00343785|Secondary|Number of Days to Neutrophil Recovery to >500/uL|First of 3 consecutive days of neutrophils >500/uL|100 days post-transplant|All patients|||days||Full Range|Median
2817641|NCT00400153|Secondary|FEV1 AUC0-4 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817642|NCT00400153|Secondary|FEV1 AUC0-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817643|NCT00400153|Secondary|FEV1 AUC0-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817644|NCT00400153|Secondary|FEV1 AUC0-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817645|NCT00400153|Primary|FEV1 AUC4-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours|||liters||Standard Error|Least Squares Mean
2817646|NCT00400153|Primary|FEV1 AUC0-4 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817647|NCT00400153|Primary|FEV1 AUC0-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data|||liters||Standard Error|Least Squares Mean
2817648|NCT00399893|Primary|Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months|Number of participants with improved Peptide YY (PYY) regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis|||participants|||Number
2817649|NCT00399893|Primary|Number of Participants With Improved Leptin Regulation From Baseline to 6 Months|Number of participants with improved Leptin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months||||participants|||Number
2817650|NCT00399893|Primary|Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months|Number of participants with improved Adiponectin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but data was used for analysis|||participants|||Number
2817651|NCT00399893|Primary|Number of Participants With Improved Insulin Regulation From Baseline to 6 Months|Number of participants with improved Insulin regulation from baseline to 6 months of Octreotide or Placebo therapy. Insulin regulation was measured by immunochemiluminescent assay.|6 months|Participant withdrew but was used in the data analysis|||participants|||Number
2817652|NCT00399893|Secondary|Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA|Number of participants with decreased body-composition as Measured by Dual Energy X-ray Absorptiometry (DEXA) scan from baseline to 6 months of Octreotide or Placebo therapy|6 months|Data for this outcome was not analyzed|||participants|||Number
2817653|NCT00399893|Primary|Number of Participants With Decrease in Hunger and Food Intake|Measured by hunger and hyperphagia by questionnaires and parent-reported 72-hour food recall from baseline to 6 months. Multiple questionnaires consisting of a battery of free text answer questions and food diaries are combined in order to make a behavioral assessment of the participants food state of hunger and food intake. There is no defined scale for this assessment. Each participants responses and parent responses are combined.|6 months|For this outcome measure, data from questionnaires and forms was not completed. Data for all questionnaires is not available to report.||||||
2817654|NCT00399893|Primary|Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months|Number of participants with decreased skin-fold measurements from baseline to 6 months of Octreotide or Placebo therapy|6 months|The skin fold measurements were performed; however, the data was not completed in a manner that could be analyzed; therefore we could not analyze the data. Completed data is not available to complete this outcome.||||||
2817655|NCT00399893|Primary|Number of Participants With Decreased BMI Z-score From Baseline to 6 Months|Number of participants with decreased BMI z-score from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but was included in analysis|||participants|||Number
2817656|NCT00399893|Primary|Number of Participants With Decrease in Weight From Baseline to 6 Months|Number of participants who had a decrease in weight from baseline to 6 months of Octreotide or placebo therapy|6 months||||participants|||Number
2817657|NCT00399893|Secondary|Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD®|Number of participants with decreased body-composition as Measured by BOD POD® body composition tracking system from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis|||participants|||Number
2817658|NCT00399893|Primary|Number of Participants With Decrease in Fasting Total Ghrelin|Number of participants showing a decrease in Fasting total ghrelin from baseline to 6 months of treatment with Octreotide or placebo|6 months|"Descriptive statistics or percent of change from the baseline for the 5 patients was used.~A patient withdrew but included in analysis."|||Participants|||Number
2817659|NCT00399880|Secondary|Self-Efficacy for Appropriate Medication Use Scale (SEAMS)|Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.|Approximately 2 weeks after hospital discharge|Participants who were able to be contacted and provided outcome data.|||units on a scale||Standard Deviation|Mean
2817660|NCT00399880|Primary|Adherence to Refills and Medications Scale (ARMS)|Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.|Approximately 2 weeks after hospital discharge|Participants who were able to be contacted and provided outcome data.|||units on a scale||Standard Deviation|Mean
2817661|NCT00399802|Secondary|Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4|u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD.|Baseline and Week 4|All randomized participants who took at least one dose of study drug and had available u-DPD data for Baseline and Week 4|||Percentage change||95% Confidence Interval|Mean
2817662|NCT00399802|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 4 weeks|All randomized participants who took at least one dose of study drug|||Participants|||Count of Participants
2817663|NCT00399802|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 6 weeks|All randomized participants who took at least one dose of study drug|||Participants|||Count of Participants
2817664|NCT00399802|Primary|Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4|u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.|Baseline and Week 4|All randomized participants who took at least one dose of study drug and had available u-NTx data for Baseline and Week 4|||Percentage change||95% Confidence Interval|Mean
2817665|NCT00399763|Secondary|Side Effect Form for Children and Adolescents (SEFCA)|The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment.|weekly from randomization to 12 weeks post-randomization||||Number of serious adverse events|||Number
2817666|NCT00399763|Secondary|Time Line Followback Interview (TLFB)|The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis.|12 weeks||||days||95% Confidence Interval|Mean
2817667|NCT00399763|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist|All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.|baseline and weekly through week 12 post randomization||||units on a scale||95% Confidence Interval|Mean
2817668|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.|"Number of subjects who reported SAEs during the study.~A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:~Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event"|32 days following first dose of study medication.||||Subjects|||Number
2817669|NCT00399568|Primary|Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-4800 mm for 48 hours."|Baseline (just prior to the first dose) through 48 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.|||units on a scale (in millimeters)||Standard Deviation|Mean
2817670|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)|Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)|First dose through 7 day follow up|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of study medication.|||Subjects|||Number
2817671|NCT00399568|Primary|Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-2400 mm for 24 hours."|Baseline (just prior to the first dose) through 24 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.|||units on a scale (in millimeters)||Standard Deviation|Mean
2817672|NCT00399542|Secondary|Month 3 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF|||BMs/week||Standard Deviation|Mean
2817673|NCT00399542|Secondary|Month 2 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF|||BMs/week||Standard Deviation|Mean
2817674|NCT00399542|Secondary|Month 1 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF|||bowel movements (BMs)/week||Standard Deviation|Mean
2817675|NCT00399542|Secondary|Month 3 Quality of Life Change From Baseline|IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|12 weeks|ITT without LOCF|||units on a scale||Standard Deviation|Mean
2817692|NCT00399542|Secondary|Month 3 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF|||percentage of participants|||Number
2817693|NCT00399542|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF|||percentage of participants|||Number
2817694|NCT00399542|Secondary|Month 1 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF|||percentage of participants|||Number
2817695|NCT00399542|Secondary|Month 1 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2817696|NCT00399542|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2817697|NCT00399542|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2817698|NCT00399542|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF|||units on a scale||Standard Deviation|Mean
2817699|NCT00399542|Secondary|Month 1 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF|||spontaneous bowel movements (SBMs)/week||Standard Deviation|Mean
2817700|NCT00399542|Primary|Overall Responder Status|"Overall responder: monthly responder for at least 2 out of 3 months~Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|12 weeks|Intention to treat (ITT), without Last Observational Carried Forward (LOCF).|||percentage of participants|||Number
2817701|NCT00399529|Secondary|Number of Participants With Delayed Type Hypersensitivity (Immunological Response)|The number of participants with a Delayed Type Hypersensitivity (DTH) response was measured as an indicator of immune response. Participants were considered to have a DTH response if they had increased induration (>5mm from baseline) at the site of injection 2-3 days after intradermal injection with human epidermal growth factor receptor 2 (HER-2) peptides. This peptide injection was given 28 days after each dose of vaccine.|30 days after each vaccine, up to 9 months||||Participants|||Count of Participants
2817702|NCT00399529|Primary|Number of Participants With Clinical Benefit|Clinical benefit is defined as the proportion of patients achieving complete response, partial response, or stable disease by RECIST. Complete response (CR) is defined as total disappearance of all clinical evidence of reversible disease. A partial response (PR) is defined as a >=30% reduction in tumor target lesions. Stable disease (SD) is defined as disease status that fails to qualify as as a response (CR or PR) or progressive disease (increase of at least 20% in tumor target lesions).|At 6 and 12 months from start of treatment||||Participants|||Count of Participants
2817703|NCT00399529|Primary|Number of Participants With Adverse Events|Safety is measured as the number of patients that experienced adverse events related to study drug.|From first dose through 30 days after last dose of study drug, up to 9 months||||Participants|||Count of Participants
2817704|NCT00399516|Primary|Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)|"Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable"|Within 6 months post-implantation||||Percent Change in Pain Rating||Standard Deviation|Mean
2817705|NCT00399360|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) of the tibialis anterior was determined using 1H-magnetic resonance spectroscopy (Siemens, Munich, Germany). The change in the intramyocellular lipid measurement between baseline and 12 months is reported.|baseline and 12 months||||mmol/kg||Standard Error|Mean
2817706|NCT00399360|Secondary|Cardiorespiratory Fitness|A submaximal exercise stress test was conducted on a cycle ergometer to measure endurance. Subjects cycled between 50-60 revolutions per minute and the workload was progressively increased in increments of 50 watts in stages lasting 3 minutes. Once subjects became fatigued or reached their submaximal heart rate (220-age x 85), the test was stopped and separate readings of heart rate and blood pressure were measured at 1, 3, and 5 min of recovery. Weight-adjusted maximum oxygen consumption (VO2max; ml/kg per minute) was determined. The change in cardiorespiratory fitness between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||ml/kg/min||Standard Error|Mean
2817707|NCT00399360|Secondary|Abdominal Visceral Adiposity|Abdominal visceral adipose area was assess by magnetic resonance imaging at the lvel of the L4 pedicle. The change in abdominal visceral adiposity between baseline and 12 months is reported.|baseline and 12 months||||cm2||Standard Error|Mean
2817708|NCT00399360|Secondary|C-reactive Protein|High sensitivity C-reactive protein was determined by R&D Systems (Minneapolis, MN) kit. The change in C-reactive protein between baseline and 12 months is reported.|baseline and 12 months||||mg/l||Standard Error|Mean
2817733|NCT00398567|Secondary|Terminal-phase Elimination Half-life of Neratinib in Combination With Trastuzumab.|Terminal-phase elimination half-life of Neratinib at day 22 following Administration of Neratinib 240 mg in combination with Trastuzumab 2 mg/kg to Subjects with Cancer.|Prior to the first dose, on days 22 through 23 of month 1, and on day 1 in months 2 through 6|Subjects for whom complete blood samples at day 22 were available.|||hr||Standard Deviation|Mean
2825124|NCT00343785|Primary|Incidence of Chronic GVHD|Analyzed using cumulative incidence estimates, treating death or rejection as competing risk events.|2 years|All Patients|||number participants with chronic GVHD|||Number
2817709|NCT00399360|Primary|Coronary Artery Calcium Score|Computed tomography (CT) imaging was performed using a SOMATOM Sensation (Siemens Medical Solutions, Forcheim, Germany) 64-slice CT scanner. Agatston calcium score was calculated using CT images. The total Agatston score is calculated by summing up the scores of the individual calcifications in all slices of the CT scan. An absolute Agatston score of less than 10 indicates minimal overall atherosclerosis (plaques) in the coronary arteries. The change in the coronary artery calcium score between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||Agatston score||Standard Error|Mean
2817710|NCT00399360|Primary|Systolic Blood Pressure|Systolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure between baseline and 12 months is reported.|baseline and 12 months||||mm Hg||Standard Error|Mean
2817711|NCT00399360|Primary|Glucose|Glucose level was determined after an overnight fast. The change in glucose between baseline and 12 months is reported.|baseline and 12 months||||mg/dL||Standard Error|Mean
2817712|NCT00399360|Primary|High Density Lipoprotein (HDL)|High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||mg/dL||Standard Error|Mean
2817713|NCT00399360|Primary|Waist Circumference|Iliac waist circumference measurements were obtained using an inelastic tape measure. All measurements were obtained in triplicate, with the patient undressed, and then averaged. The change of the waist circumference measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||cm||Standard Error|Mean
2817714|NCT00399360|Primary|Carotid Intima Media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.|||mm||Standard Error|Mean
2817715|NCT00399308|Secondary|Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).|The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.|24 weeks|Intent-to-Treat population|||participants|||Number
2817716|NCT00399308|Secondary|Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.|The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.|Variable - minimum of 12 weeks of follow-up.|Intent-to-treat population achieving primary outcome|||participants|||Number
2817717|NCT00399308|Secondary|Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.|Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.|12 Weeks|Intent-to-Treat population|||participants|||Number
2817718|NCT00399308|Primary|Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.|The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)|12 weeks|Intent-to-Treat population (i.e. all subjects randomized to treatment)|||participants|||Number
2817719|NCT00399035|Secondary|Time to Wound Healing Complications|Number of days from post-randomisation surgery until wound healing complications|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Days||Full Range|Median
2817720|NCT00399035|Secondary|Rate of Resection of Liver Metastases|Number of patients undergoing liver resection, based on patients with liver disease at baseline|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Participants|||Number
2817721|NCT00399035|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period from initial response up until data cut-off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
2817722|NCT00399035|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Percentage [change in tumour size (mm) ]||Standard Deviation|Mean
2818479|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2817723|NCT00399035|Secondary|Overall Response Rate|Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Participants|||Number
2817724|NCT00399035|Primary|Overall Survival|Number of months from randomisation to the date of death from any cause|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
2817725|NCT00399035|Primary|Progression-free Survival|RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.|RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
2817726|NCT00398983|Primary|Number of Participants With Relapse-Free Response at 1 Year|Relapse free response defined an absence of relapse at one year of follow up.|Baseline to 1 year||||participants|||Number
2817727|NCT00398918|Secondary|Score Digit Symbol Modalities Test|Difference score between zonisamide and placebo treatment conditions for the Digit Symbol Modalities Test scores obtained 40 minutes after ingestion of a priming dose of ethanol.This test involves transcribing from a key in which numbers appear below a series of symbols to boxes below symbols matched to those in the key. This task must be completed in 90 nseconds. This test measures visuomotor speed and aspects of attention. Scoring is the total number of correctly transcribed numbers. The maximum score on this test 110 points.|40 minutes post alcohol ingestion|ITT|||Numeric Score||Standard Error|Mean
2817728|NCT00398918|Primary|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions|1 day|This was a laboratory based study. An ITT analysis was used.|||Grams||Standard Error|Mean
2817729|NCT00398866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability.|Baseline, 26 Weeks|Patients who completed follow-up through 26 weeks|||units on a scale||Standard Deviation|Mean
2817730|NCT00398866|Primary|Pain Visual Analogue Scale (VAS)|Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.|Baseline, 26 Weeks|Patients who completed follow-up through 26 weeks|||Units on a scale||Standard Deviation|Mean
2817731|NCT00398632|Secondary|Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study|The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study.|Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)|All participants; the last observed non-missing value was used (LOCF)|||Participants|||Count of Participants
2817732|NCT00398632|Primary|Global Clinical Impressions Improvement Score re Sexual Functioning|The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.|baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)|Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12.|||participants|||Number
2817734|NCT00398567|Secondary|Area Under the Curve of Neratinib Concentration|Area Under the Curve of Neratinib concentration at day 22 following Administration of Neratinib 240 mg in combination with Trastuzumab 2 mg/kg in Subjects with Cancer.|Prior to the first dose, and at hours 1, 2, 4, 6, 8 and 24 on days 22.|Subjects for whom complete blood samples at day 22 were available.|||ng*hr/mL||Standard Deviation|Mean
2817735|NCT00398567|Secondary|Clinical Benefit Rate (CBR)|The percentage of participants with a best overall response of a complete response (CR) or partial response (PR) or stable disease (SD) >=24 weeks.|From first dose date to progression or last tumor assessment, assessed up to five and half years.|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||percentage of participants||95% Confidence Interval|Number
2817736|NCT00398567|Secondary|Progression Free Survival (PFS)|Progression Free Survival was measured from the date of the first dose of test article until the first date on which recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment.|From first dose date to progression or death, assessed up to five and half years.|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||weeks||95% Confidence Interval|Median
2817737|NCT00398567|Secondary|Duration of Response (DOR)|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date on which recurrence or PD was objectively documented, taking as the reference for PD the smallest measurements recorded since the test article administration started.|From start date of response to first PD, assessed up to five and half years after the first subject was randomized|The subjects who had a complete response or partial response.|||weeks||95% Confidence Interval|Median
2817738|NCT00398567|Secondary|Objective Response Rate (ORR)|Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to five and a half years.|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||percentage of participants||95% Confidence Interval|Number
2817739|NCT00398567|Primary|16-week Progression-free Survival (PFS) Rate|16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population.|From first dose date to progression status (PD or death) at 16-week|The evaluable population was defined as the subjects who met the eligibility criteria for study enrollment, received at least 1 week of neratinib and at least 2 doses of trastuzumab, and had a baseline tumor assessment and at least 1 follow-up tumor assessment approximately 8 weeks after starting test article administration.|||percentage of population||95% Confidence Interval|Number
2817740|NCT00398476|Secondary|Number of Participants Comply With Product if Prescribed in DAQ|Number of participants responding to product attributes using delayed attributes questionnaire, Question: How likely to comply if prescribed?. Participants specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817741|NCT00398476|Secondary|Number of Participants Reported Nasal Irritation Bothersome in DAQ|Participant response regarding bothersome of nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How bothersome was nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817742|NCT00398476|Secondary|Number of Participants Reported Nasal Irritation in DAQ|Participant response regarding nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product cause nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slight; 2: slight; 3: neither slight nor moderate; 4: moderate; 5; marked; 6: very marked.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817743|NCT00398476|Secondary|Number of Participants Satisfied With Product in DAQ|Number of participants responding to product satisfaction with delayed attributes questionnaire, Question: How satisfied with product?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817744|NCT00398476|Secondary|Number of Participants Reported Product Make Want to Sneeze in IAQ|Participant response regarding sneezing effect at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product make want to sneeze?. Participants specified their responses on a 6-point scale: 0: No urgency; 1: Very slight urgency; 2: slight urgency; 3: Neither slight nor moderate urgency; 4: Moderate urgency; 5; Marked urgency; 6: Very marked urgency.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817745|NCT00398476|Secondary|Number of Participants Reported Product Feel Soothing in IAQ and DAQ|Participant response for soothing feel at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product feel soothing?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.|Day 1|Per Protocol population comprised of all participants who complete both treatment periods. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2818503|NCT00394901|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
2817746|NCT00398476|Secondary|Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ|Participant response regarding did the medicine run out of nose at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run out of nose? Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817747|NCT00398476|Secondary|Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ|Participant response regarding did the medicine run down throat at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run down throat? Participants specified their responses on a 6-point scale: 0: None; 1: Very slightly; 2: Slightly; 3: Neither slightly nor moderately; 4: Moderately; 5: Markedly; 6: Very markedly.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2817748|NCT00398476|Secondary|Number of Participants Satisfied With an After Taste in DAQ|Participant response for satisfaction with an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How satisfied with aftertaste? Participants specified their responses on a 6-point scale: 0: Very satisfied; 1: Moderately satisfied; 2: Somewhat satisfied; 3: Neither satisfied nor dissatisfied; 4: Somewhat dissatisfied; 5: Moderately dissatisfied; 6: Very dissatisfied.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817749|NCT00398476|Secondary|Number of Participants Reported Product Have an After Taste in DAQ|Participant response for an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product have an aftertaste?. Participants specified their responses on a 6-point scale: 0: No aftertaste; 1: Very mild; 2: Mild; 3: Neither mild nor strong; 4: Slightly strong; 5: Moderately strong; 6: Very strong.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817750|NCT00398476|Secondary|Number of Participants Satisfied With an Immediate Taste in IAQ|Participant preference for satisfaction with an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with immediate taste?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817751|NCT00398476|Secondary|Number of Participants Reported Product Have an Immediate Taste in IAQ|Participant preference for an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product have an immediate taste?. Participants specified their responses on a on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong.|Day 1|Per protocol population. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817752|NCT00398476|Secondary|Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ|Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2817753|NCT00398476|Secondary|Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ|Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2817754|NCT00398476|Secondary|Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ|Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2817755|NCT00398476|Secondary|Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ|Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.|Day 1|Per protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2817756|NCT00398476|Secondary|Number of Participants With Preference for Scent/Odor in IAQ and DAQ|Participant preference for scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product have a scent/odor?. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Higher score indicated strong odor.|Day 1|Per Protocol population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2817804|NCT00397982|Secondary|Comparison of Pre- vs Post-treatment Measurements of Biomarkers and Vascular System/Immune System Parameters|Biomarker expression in tumor and normal skin will be assessed by immunohistochemistry (IHC) or Western blotting, using marker-specific antibodies.|Day 1 of course 1 and day 8 of course 2|Detailed vascular changes were not assessed.||||||
2817757|NCT00398476|Primary|Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing|An overall preference questionnaire (OPQ) was used to evaluate participant's preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.|Day 1|Per Protocol population comprised of all participants who completed both treatment periods. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2817758|NCT00398411|Secondary|Overall Survival||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)|||participants|||Number
2817759|NCT00398411|Secondary|Type of Infection||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)|||participants|||Number
2817760|NCT00398411|Secondary|Reason for Discontinuation of Treatment|Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||participants|||Number
2817761|NCT00398411|Secondary|Time to Occurrence of Fever >= 38°C||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||days||Standard Deviation|Mean
2817762|NCT00398411|Secondary|Type of Isolates and Infections||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||participants|||Number
2817763|NCT00398411|Primary|Incidence of Clinically Significant Bacteremia|"Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.~With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant."|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)|||participants|||Number
2817764|NCT00398398|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab|1 years||||participants|||Number
2817765|NCT00398398|Secondary|Overall Survival||1 year||||months||95% Confidence Interval|Median
2817766|NCT00398398|Secondary|Progression-free Survival||1 year||||months||95% Confidence Interval|Median
2817767|NCT00398398|Primary|Overall Response Rate|Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.|6 months||||participants|||Number
2817768|NCT00398320|Secondary|Biochemical Markers||Assessed every 3 weeks while on treatment|18 of 40 patients had elevated baseline hormone markers, including Chromogranin A, Gastrin, Glucagon, Pancreatic Polypeptide, vasoactive intestinal peptide (VIP), Urine 5HIAA|||participants|||Number
2817769|NCT00398320|Secondary|Overall Survival (OS)|OS is defined as time from enrollment until death from any cause.|Continuous||||months||Full Range|Median
2817770|NCT00398320|Secondary|Response Rates|Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as ≥ 30 decrease in the sum of longest diameters of target lesions (SLD). Overall response (OR) = CR + PR.|Response rates by RECIST criteria assessed every 3 months while on treatment||||percentage of participants|||Number
2817771|NCT00398320|Primary|Number of Patients Who Experienced Treatment-related Grade 3 or Higher Adverse Events by CTCAE Version 3.0|Participants were monitored every 3 weeks while on study. Toxicity and attributions were as per CTCAE version 3.0 guidelines. Analysis population below is patient who experienced related Grade 3 or higher AE; denominator is 40 total patients enrolled.|30 days after last treatment||||participants|||Number
2817772|NCT00398320|Primary|12-month Progression Free Survival (PFS)|Percentage of participants with 12-month progression-free survival (PFS) was assessed. PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first). RECIST criteria (version 1). Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR) defined as ≥ 30% decrease of SLD. Progressive disease (PD) defined as ≥ 20% increase in Sum Longest Diameters (SLD). Stable Disease (SD) defined as being between 20% increase and < 30% decrease in SLD.|PFS assessed every 3 months through 12 months||||percentage of participants w/ 12 mo PFS|||Number
2817773|NCT00398216|Secondary|Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events|adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose|10 days after first dose|safety analysis dataset|||percentage of subjects with bleed events||95% Confidence Interval|Number
2817774|NCT00398216|Secondary|Change in Activated Partial Thromboplastin Time (aPTT) From Baseline|change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set|||seconds||Standard Deviation|Mean
2817775|NCT00398216|Secondary|Change in Prothrombin Time (PT) From Baseline|change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set|||seconds||Standard Deviation|Mean
2817805|NCT00397982|Secondary|Comparison of Biomarkers to Antitumor Activity/Patient Outcomes|Assessed in both tumor tissue pretreatment. Mutations in BRAF were assessed in all 16 of the patients and were assessed for any association with clinical response|Day 1 of course 1 and day 8 of course 2|Patients evaluable for clinical outcome with BRAF mutation status.|||Participants|||Count of Participants
2817776|NCT00398216|Primary|Adjudicated Incidence of VTE|"Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.~A subject was judged to have a VTE if one or more of the following criteria were met:~Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit~Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit~Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery."|end of treatment|per protocol analysis set|||percentage of participants with VTE||95% Confidence Interval|Number
2817777|NCT00398138|Primary|Immune Response|Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.|2 years||||participants|||Number
2817778|NCT00398138|Primary|Safety|Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).|2 years||||participants|||Number
2817779|NCT00398112|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR or PR) until the date of progression or last follow-up in the subset of patients who responded. The median duration of response with 95%CI was estimated using the Kaplan Meier method|Duration on study (up 2 years)|No participants had a confirmed response, there for this analysis cannot be completed.||||||
2817780|NCT00398112|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from registration to progression or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)||||months||95% Confidence Interval|Median
2817781|NCT00398112|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause. The distribution of survival time was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)||||Months||95% Confidence Interval|Median
2817782|NCT00398112|Secondary|Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia|Complete response is described in the primary outcome|Duration of Treatment (up to 12 cycles)|No participants had a confirmed response, there for this analysis cannot be completed.||||||
2817783|NCT00398112|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response. >~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy >~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Duration of Treatment (up to 12 cycles)||||participants|||Number
2817784|NCT00398086|Secondary|Maximal Degree of Anemia|The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data|||g/L||Standard Deviation|Mean
2817785|NCT00398086|Secondary|Maximal Degree of Myelosuppression|The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data|||x10^9/L||Standard Deviation|Mean
2817786|NCT00398086|Secondary|Overall Survival|Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods.|Up to approximately 4 years|Treated patients|||months||95% Confidence Interval|Median
2817787|NCT00398086|Secondary|Duration of Response|Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer.|Up to approximately 4 years|Treated patients with an overall confirmed Complete Response or Partial Response.|||months||95% Confidence Interval|Median
2817788|NCT00398086|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.~Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients|||months||95% Confidence Interval|Median
2817789|NCT00398086|Secondary|Percentage of Participants With Disease Control|"Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.~Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients|||percentage of participants||95% Confidence Interval|Number
2817854|NCT00397891|Secondary|Maximum Observed Serum Concentration (Cmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|Pharmacokinetic (PK) data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2817790|NCT00398086|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response|"Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.~CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.~PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing."|Up to approximately 4 years|Treated patients|||percentage of participants||95% Confidence Interval|Number
2817791|NCT00398086|Secondary|Number of Participants With Adverse Events (AE)|"An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient's treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.~A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~Treatment-related AEs (TRAEs) include those assessed by the Investigator as possibly, probably, or definitely related to study treatment.~Severity was graded according to the NCI CTCAE based on the following: Grade 1- Mild; Grade 2 -Moderate; Grade 3 - Severe; Grade 4 - Life-threatening or disabling; Grade 5 - Death related to AE."|Up to 25 months|Treated patients: all enrolled patients who received at least one dose of study drug.|||participants|||Number
2817792|NCT00398086|Primary|Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:~Grade 4 neutropenia lasting >3 days in the absence of growth factor support;~Grade 4 neutropenia associated with fever >38.5°C;~Any other Grade 4 hematological toxicity;~Grade 3 thrombocytopenia with hemorrhage;~Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;~Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue."|Cycle 1 (Days 1-28)|Phase 1 treated population|||participants|||Number
2817793|NCT00398073|Secondary|Number of Participants With Response|In patients with measurable disease, the RECIST criteria for anti-tumor effect will be used. Lesions will be defined as measurable if they can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm by spiral CT scan.Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 years||||participants|||Number
2817794|NCT00398073|Primary|Number of Participants With a T-cell Response|T-cell response: Peripheral blood lymphocytes will be tested for reactivity against gp100 using an IFN-y ELISPOT, intracellular cytokine staining or MHC tetramer assay. If T-cell reactivity is induced, additional samples may be drawn to determine the duration of this reactivity. Follow-up blood samples require only 20-30 ml. MHC tetramer assays and intracellular flow cytometry studies may also be performed.|2 years||||participants|||Number
2817795|NCT00398073|Primary|Number of Patients Evulated for Toxicity and Safety|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years||||participants|||Number
2817796|NCT00398047|Secondary|Expression of p53 and p21||Approximately 12 months|Because no patients completed therapy, no analysis was possible||||||
2817797|NCT00398047|Secondary|Change in Bone Marrow Apoptosis||Baseline and approximately 12 months|Because no patients completed therapy, no analysis was done||||||
2817798|NCT00398047|Secondary|Overall Survival||Approximately 12 months|Because no patients completed therapy, and the protocol was closed early, analysis was not performed||||||
2817799|NCT00398047|Secondary|Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death|Death during treatment or disease progression characterized by worsening of cytopenias, increase in the percentage of the blasts, reduction of hemoglobin concentration by at least 2 g/dl or transfusion dependence in the absence of another explanation, such as acute infection, gastrointestinal bleeding, hemolysis.|Approximately 12 months|Because no patients completed therapy, no analysis was possible||||||
2817800|NCT00398047|Secondary|Minor Hematological Improvements|For patients with pretreatment platelet count less than 100,000/mm3, a 50% or more increase in platelet count with a net increase greater than 10,000/mm3 but less than 30,000/mm3|Approximately 112 days|Because no patients completed therapy, no analysis was possible||||||
2817801|NCT00398047|Primary|Rate of Major Hematological Improvement|For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.|Approximately 112 days|Because no patients completed therapy, no analysis was possible||||||
2817802|NCT00398047|Primary|Number of Participants With Complete Response|Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.|Approximately 112 days|There were a total of 3 patients accrued on this trial. All were eligible and evaluable for response and evaluable for toxicity, as per protocol.|||Participants|||Number
2817803|NCT00397982|Secondary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression, death or date of last follow-up.|Day 11 of courses 4, 8, 12, 16, 20, and 24, and then annually for up to 5 years|Entire study|||months||Full Range|Median
2817806|NCT00397982|Secondary|Association Between Expression or Activation of One Biomarker With Another, With Biochemical and Clinical Responses, With Alterations in Cell Proliferation and Apoptotic Markers, and With Time to Progression|Changes in the ratio of phospho-S6Kinase (pS6K) S240/244 to total S6, in the tumor, from day 1 to day 23. These were assessed by reverse-phase protein array. A linear model was fit with PROC MIXED in SAS 9.3 using the log base 10 of expression as the outcome measure. This measure type is not listed in the data table form; so the number of patients who had decreases in that ratio is listed.|Day 1 of course 1 and day 8 of course 2|This analysis was performed for those participants with sufficient tumor available for analysis.|||participants who had decreases in ratio|||Number
2817807|NCT00397982|Secondary|Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab|Defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during the study (having been absent at baseline) or if present at baseline, appears to worsen. Graded using scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated by type and severity: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|On days 1 and 8 of each cycle, and up to 2 years after registration.|Treatment related adverse events.|||participants|||Number
2817808|NCT00397982|Primary|Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab|Evaluated using Response Evaluation Criteria In Solid Tumor (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 18 weeks after registration.||||participants|||Number
2817809|NCT00397943|Secondary|Concentrations of IFN-γ Produced in Serum Samples|Concentrations are presented as geometric mean concentrations (GMCs), expressed in picogram per milliliter (pg/mL). The reference seropositivity cut-off value was equal to or above (≥) 1 pg/mL.|Prior to (Day 0 and Day 30) and one day (Day 1 and Day 31) after each vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||pg/mL||95% Confidence Interval|Geometric Mean
2817810|NCT00397943|Secondary|Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers|The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||Participants|||Count of Participants
2817811|NCT00397943|Secondary|Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers|The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2817812|NCT00397943|Secondary|Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule|Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2817813|NCT00397943|Secondary|Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule|Expressed cytokine combinations for CD4+ T-cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2817814|NCT00397943|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2817831|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817815|NCT00397943|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). Note: No vaccine induced responses were observed for CD8+ T-cells, so no results are presented throughout the record.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2817816|NCT00397943|Secondary|Antibody Concentrations Against M. Tuberculosis Fusion Protein M72|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EU/mL). The reference seropositivity cut-off value for anti-M72 antibodies was ≥ 2.8 EU/mL.|At Year 2 (Month 24) and Year 3 (Month 36)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).|||EU/mL||95% Confidence Interval|Geometric Mean
2817817|NCT00397943|Secondary|Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The reference seropositivity cut-off values for anti-M72 and anti-Mtb72F antibodies were ≥ 2.8 EU/mL and ≥ 1.0 EU/mL, respectively.|At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)|The analysis was performed on the According to protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2817818|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
2817819|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 31|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
2817820|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
2817821|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
2817822|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
2817823|NCT00397943|Primary|Levels of Immunoglobulin E|The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||1000 U/L||Inter-Quartile Range|Median
2817824|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2817825|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 31|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2817826|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2817827|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2817828|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2817829|NCT00397943|Primary|Levels of C-reactive Protein|The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2817830|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817865|NCT00397878|Secondary|Time to Progression|Number of participants who progressed on treatment within less than or equal to 2 cycles (cycle=28 days; within 54 days PD).|within 54 days||||Participants|||Count of Participants
2817866|NCT00397878|Secondary|Overall Survival|Number of participants who survived up to 5 years|Up to 5 years||||Participants|||Count of Participants
2817832|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817833|NCT00397943|Primary|Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817834|NCT00397943|Primary|Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels|Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817835|NCT00397943|Primary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 3 continued only for the M72/AS01B Group and M72/AS02A Group.|From Month 24 up to Month 36|The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 3 Safety Follow-Up (M72/AS01B and M72/AS02A groups).|||Participants|||Count of Participants
2817836|NCT00397943|Primary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 2 continued only for the M72/AS01B Group and M72/AS02A Group.|From Month 12 up to Month 24|The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 2 Safety Follow-Up (M72/AS01B and M72/AS02A groups).|||Participants|||Count of Participants
2817837|NCT00397943|Primary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 2 up to Month 12|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817838|NCT00397943|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the Active Vaccination Phase (from Day 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817839|NCT00397943|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817840|NCT00397943|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817841|NCT00397943|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2817853|NCT00397891|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||hours||Full Range|Median
2817882|NCT00397540|Secondary|Overall Survival|Overall Survival: Number of Participants who Died|through study completion, an average of 3 years||||participants|||Number
2817842|NCT00397930|Primary|Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)|"Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.~PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms."|2-24 months after surgery, chemotherapy, and/or radiation therapy||||units on a scale||Standard Error|Mean
2817843|NCT00397904|Primary|Complete and Partial Response Rate||2 years||||participants|||Number
2817844|NCT00397891|Secondary|Plasma Amyloid-beta (x-40) Concentrations|Amyloid-beta (A-beta) is a peptide fragment of the amyloid precursor protein which is one of the characteristic hallmarks of Alzheimer's disease (AD). Total plasma amyloid-beta (x-40) was determined using a validated ELISA method.|0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2817845|NCT00397891|Secondary|Number of Participants With Positive Serum Anti-Bapineuzumab Antibody|Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method.|Baseline (Day 1) up to Week 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||participants|||Number
2817846|NCT00397891|Secondary|Serum Bapineuzumab Concentrations|Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2817847|NCT00397891|Secondary|Serum Decay Half-Life (t1/2) of Bapineuzumab|Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||days||Standard Deviation|Mean
2817848|NCT00397891|Secondary|Mean Residence Time of Bapineuzumab|MRT is average time for which the drug molecules resides in the body, after administration. It is calculated as area under the serum concentration versus time first moment curve from time zero (pre-dose) to extrapolated infinite time (AUMC [0 - ∞]) divided by area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (AUC[0 - ∞]). AUMC (0-∞) is calculated as AUMC(0-inf)= AUMCt + [(t x Ct) / kel] + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method, Ct is the concentration at time t and kel is the terminal phase rate constant. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||days||Standard Deviation|Mean
2817849|NCT00397891|Secondary|Volume of Distribution at Steady State (Vss) of Bapineuzumab|Volume of distribution is defined as the theoretical blood volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mL||Standard Deviation|Mean
2817850|NCT00397891|Secondary|Systemic Clearance (CL) of Bapineuzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mL/hour||Standard Deviation|Mean
2817851|NCT00397891|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0 - ∞) is area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mcg*hour/mL||Standard Deviation|Mean
2817852|NCT00397891|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0-t) is area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.|||mcg*hour/mL||Standard Deviation|Mean
2817855|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2817856|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2817857|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 6|Safety data set included all randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2817858|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Neurological Examinations|Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2817859|NCT00397891|Primary|Number of Participants With Laboratory Test Results of Potential Clinical Importance|Criteria for PCI laboratory results: hematology (hematocrit [decrease >=5%], hemoglobin [decrease >=20gram/liter {g/L}] from baseline, white blood cells [<3], neutrophils [<1.5], platelet [<100], eosinophils [>0.5] *10^9/L); blood chemistry (sodium [>5], potassium [>0.5], fasting glucose [>0.83], phosphorous [>0.162] millimole/L [mmol/L] above upper limit of normal [ULN] and below lower limit of normal [LLN], non-fasting glucose >5 mmol/L above ULN, >0.56 mmol/L below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, calcium [change of >=0.25 mmol/L], total protein [change of >=20g/L], albumin [change of >=10g/L], uric acid [change of >0.119mmol/L] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] >2*ULN, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, gamma-glutamyl-transpeptidase [GGT] >3*ULN).|Week 1 up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2817860|NCT00397891|Primary|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance|Criteria for determining PCI ECG result was described as: heart rate (>=120 bpm or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), PR interval (>=220 millisecond (msec) and change of >=20 msec compared to baseline value), QRS interval (>=120 msec), corrected QT (QTc) interval for men (>450 msec), QTc interval for women (>470 msec).|Screening up to Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2817861|NCT00397891|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to [>=]160 millimeter mercury [mm Hg] or less than or equal to [<=]90 mm Hg and increase or decrease of >=20 mm Hg compared to baseline value), supine diastolic BP (>=100 mm Hg or <= 50 mm Hg and increase or decrease of >=15 mm Hg compared to baseline value), supine pulse rate (>=120 beats per minute (bpm) or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), body temperature (>38.3 degree Celsius and <35 degree Celsius).|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2817862|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Physical Examinations|Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2817863|NCT00397891|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2817864|NCT00397878|Other Pre-specified|Pre- and Post-treatment Expression Values for Each Biological Correlate|Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.|Up to 2 weeks|No patients consented to optional tissue analysis.||||||
2817867|NCT00397878|Primary|Median Progression Free Survival (PFS)|Time period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.|Time from start of treatment to time of progression, up to 4 months||||weeks||Full Range|Median
2817868|NCT00397839|Secondary|Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months|Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.|12 months|Intent-to-treat population|||participants|||Number
2817869|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.|||percent||Standard Error|Least Squares Mean
2817870|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 12.|||percent||Standard Error|Least Squares Mean
2817871|NCT00397839|Secondary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.|||percent||Standard Error|Least Squares Mean
2817872|NCT00397839|Primary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes participants with measurements at Baseline and Month 12.|||percent||Standard Error|Least Squares Mean
2817873|NCT00397813|Secondary|Number of Patients With Relapse/Progression|Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
2817874|NCT00397813|Secondary|Number of Patients With Progression-free Survival|Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
2817875|NCT00397813|Secondary|Number of Patients Who Engrafted|Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
2817876|NCT00397813|Secondary|Number of Patients Who Had Infections|Number of patients who experienced bacterial, fungal, or viral infections.|1 year|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
2817877|NCT00397813|Primary|Number of Patients With HCT Failure.|HCT failure will be defined as graft rejection (defined as < 5% donor T-cell chimerism) or disease progression within 200 days of transplant.|200 days|No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.|||Participants|||Count of Participants
2817878|NCT00397631|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2817879|NCT00397631|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2817880|NCT00397631|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2817881|NCT00397579|Primary|Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response|"Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.~Response to Treatment will be evaluated as follows:~Complete response (CR): patient has a normal whole blood count; platelets with absent blasts in peripheral blood or marrow; no evidence of nodal involvement or liver/spleen involvement; no skin lesion involvement.~Partial Response (PR); patient experiences a decrease of 50% or more in marrow blasts and skin lesions; and there is a decrease in the size of the nodes/liver/spleen.~Stable Disease (SD); failure to achieve at least PR, and there is no evidence of progression for 2 months.~Failure: death during treatment or disease progression characterized by an increase in the percentage bone marrow blast or an increase in skin or node/liver or spleen size.~Reported is the percentage of participants experiencing either CR, PR or SD."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months||||percentage of participants|||Number
2817892|NCT00397488|Primary|Overall Objective Response|Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria|2 years||||participants|||Number
2817893|NCT00397462|Secondary|Proximal Tibia Bone Density|Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)|One year||||percent change in bone density||Standard Error|Mean
2817894|NCT00397462|Primary|Bone Density of Proximal Femur|Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)|One year||||percent change in bone density||Standard Error|Mean
2817895|NCT00397254|Secondary|Adverse Experiences|Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Participants|||Number
2817896|NCT00397254|Secondary|Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose|Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Percentage of attacks|||Number
2817897|NCT00397254|Secondary|Percentage of Attacks With Symptom Elimination at 2 Hours|Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Percentage of attacks|||Number
2817898|NCT00397254|Secondary|Headache Severity of All Attacks|4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Units on a scale||Full Range|Median
2817899|NCT00397254|Secondary|Average Attack Duration||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Hours||Standard Deviation|Mean
2817900|NCT00397254|Secondary|Percentage of Responders|Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Percentage of Participants|||Number
2817901|NCT00397254|Secondary|Number of Migraine Attacks||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Migraine attacks||Standard Deviation|Mean
2817902|NCT00397254|Primary|Number of Days With Migraine||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).|||Days||Standard Deviation|Mean
2817903|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.|||Subjects|||Number
2817904|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Cells||Standard Deviation|Geometric Mean
2817905|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], interferon gamma [INF-g] and tumor necrosis factor-alpha [TNF-α].|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Cells||Standard Deviation|Geometric Mean
2817906|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2817907|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available|||Cells||Standard Deviation|Geometric Mean
2817908|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Cells||Standard Deviation|Geometric Mean
2817909|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents EOS, HEM, LDE, LYM and MON results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2817910|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2817911|NCT00397215|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 [Month 6], Months 6-12 and Months 12-24), for which SAEs were collected.|During the entire study period (Day 0 to Month 24).|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2817912|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.|At Days 0, 2, 21 and 23|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2817913|NCT00397215|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.|||Subjects|||Number
2818003|NCT00396630|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to Visit 4.|The analyses were performed on the Total Vaccinated Cohort|||subjects|||Number
2817914|NCT00397215|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Note: No AESIs were reported during the entire study period.|During the entire study period (Day 0 to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, on a subset of subjects enrolled for this study in Belgium.||||||
2817915|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
2817916|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
2817917|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
2817918|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817919|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817920|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817921|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817922|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817923|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817924|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Fold||95% Confidence Interval|Geometric Mean
2817925|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Fold||95% Confidence Interval|Geometric Mean
2817926|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Fold||95% Confidence Interval|Geometric Mean
2817927|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817928|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817929|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Subjects|||Number
2817930|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
2817931|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titer||95% Confidence Interval|Geometric Mean
2817932|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
2817948|NCT00397046|Primary|Maximum Tolerated Dose (MTD)|MTD is defined as the prior dose level of the dose level which has >=2 of 3 to 6 subjects that experience a neratinib-related DLT during 21 days from first dose date. A DLT is defined as any HKI-272-related nonhematologic grade 3 or any grade 4 AE according to the Common Terminology Criteria for Adverse Events version 3.0 except: Grade 3 nausea, vomiting, diarrhea, or rash unless subject was receiving appropriate medical therapy.|First dose date through 21 days|All subjects who received at least one dose.|||mg|||Number
2817933|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subjects|||Number
2817934|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subjects|||Number
2817935|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Days 0 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2817936|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subjects|||Number
2817937|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Fold||95% Confidence Interval|Geometric Mean
2817938|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2817939|NCT00397189|Secondary|The Change From Baseline in Subjective Sleep Maintenance.|Sleep maintenance as measured by number of awakening (NOA) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their NOA. The Sleep Diary question 4 (NOA) was summarized at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement.|3 weeks||||Awakenings||95% Confidence Interval|Mean
2817940|NCT00397189|Primary|The Change From Baseline in Subjective Sleep Latency.|Sleep latency (SL) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their SL. The Sleep Diary question 3 (SL) was summarised at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates reduction in sleep latency and thus considered improvement|Baseline and 3 weeks|Pre-planned analysis on ITT population age 65-80|||minutes||Standard Deviation|Mean
2817941|NCT00397150|Primary|Exclusive Breastfeeding Rates in South Africa|The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT|||participants|||Number
2817942|NCT00397150|Primary|Exclusive Breastfeeding Rates in Uganda|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT|||participants|||Number
2817943|NCT00397150|Secondary|Per Protocol Analysis of Infant Morbidity||at 3 months of age|||||||
2817944|NCT00397150|Secondary|Per Protocol Analysis of EBF Rates||at 3 months of age|||||||
2817945|NCT00397150|Secondary|Growth||(up to 6 months of age)|||||||
2817946|NCT00397150|Primary|Infant Morbidity, 2 Week Diarrhoea Prevalence||at 3 months of age||||participants|||Number
2817947|NCT00397150|Primary|Exclusive Breastfeeding Rates in Burkina Faso|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT|||participants|||Number
2817979|NCT00396981|Secondary|Target Aneurysm Recurrence||3 years||||participants|||Number
2817949|NCT00397046|Secondary|Clinical Benefit Rate|Subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) >= 24 weeks, according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). SD is defined as SD in target lesions and a non-progressive disease (PD) in nontarget lesions; A PR is defined as either a PR in target lesions and a non-PD in nontarget lesions, or a CR in target lesions and an incomplete response or SD in nontarget lesions; and a CR is defined as a CR in target lesions and a CR in nontarget lesions.|From first dose date to progression/death or last assessment, up to 9.2 months.|Subjects who received at least 14 days of continual dose administration of drug and who had undergone at least 1 follow-up tumor assessment were considered evaluable for efficacy|||percentage of participants||95% Confidence Interval|Number
2817950|NCT00397046|Secondary|Objective Response Rate (ORR)|ORR is defined as the proportion of subjects who had either a complete response (CR) or partial response (PR), according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). The modified RECIST is defined as CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of the Longest Diameters (LDs) of target lesions, taking as reference the baseline sum LDs. Response required confirmation.|From first dose date to disease progression or last tumor assessment, up to 9.2 months|Subjects who received at least 14 days of continual dose administration of drug and who had undergone at least 1 follow-up tumor assessment were considered evaluable for efficacy|||percentage of participants||95% Confidence Interval|Number
2817951|NCT00397046|Primary|Dose Limiting Toxicity (DLT)|DLT was defined as any drug-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, except the grade 3 nausea, vomiting, diarrhea, or rash, unless the subject was receiving appropriate medical therapy. Additional DLTs included the following: grade 2 or 3 diarrhea lasting 2 or more days for which the subject was receiving medical therapy or that was associated with fever or dehydration.|First dose date through 21 days|All subjects who received at least one dose.|||Participants|||Count of Participants
2817952|NCT00397033|Other Pre-specified|Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline YMRS total score of >= 16.|||points on scale||Standard Deviation|Mean
2817953|NCT00397033|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat population with a baseline YMRS total score of >= 16.|||points on a scale||Standard Deviation|Mean
2817954|NCT00397033|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|"The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to No change. Ratings of <4 are equivalent to improvement and ratings of > 4 are equivalent to worsening."|Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.|||points on a scale||Standard Deviation|Mean
2817955|NCT00397033|Primary|The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point|Intent-to-Treat population|||points on scale||Standard Deviation|Mean
2817956|NCT00397033|Secondary|Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects."|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.|||points on scale||Standard Deviation|Mean
2817957|NCT00397033|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects."|Baseline|Intent-to-Treat population.|||points on a scale||Standard Deviation|Mean
2817958|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
2817959|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
2817980|NCT00396981|Secondary|Target Aneurysm Recurrence||2 years||||participants|||Number
2817981|NCT00396981|Secondary|Technical Procedure Success||Post-procedure||||percentage of participants|||Number
2817960|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
2817961|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
2817962|NCT00397033|Other Pre-specified|Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.|||points on scale||Standard Deviation|Mean
2817963|NCT00397033|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.|||points on a scale||Standard Deviation|Mean
2817964|NCT00397033|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.|||points on a subscale||Standard Deviation|Mean
2817965|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
2817966|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population|||points on a subscale||Standard Deviation|Mean
2817967|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.|||points on subscale||Standard Deviation|Mean
2817968|NCT00397033|Secondary|Number of Participants With Response|Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of <= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.|||count of participants|||Number
2817969|NCT00397033|Primary|Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.|||points on a scale||Standard Deviation|Mean
2817970|NCT00397020|Secondary|Extrapyramidal Symptoms Rating Scale (ESRS)||each week/visit|||||||
2817971|NCT00397020|Secondary|Behavioral Activity Rating Scale (BARS)||each week/visit|||||||
2817972|NCT00397020|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)||each week/visit|||||||
2817973|NCT00397020|Secondary|Readiness to Discharge Questionnaire (RDQ)||each week/visit in the hospital|||||||
2817974|NCT00397020|Secondary|Clinical Global Impression: Improvement (CGI:I)||each week/visit|||||||
2817975|NCT00397020|Secondary|Clinical Global Impression: Severity (CGI:S)||each visit|||||||
2817976|NCT00397020|Secondary|Young Mania Rating Scale (YMRS) Secondary Endpoints||weekly - Day 3, 14, 21|||||||
2817977|NCT00397020|Primary|Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7|Minimum: 0 Maximum: 60 Higher scores indicate worse outcome|Day 7||||units on a scale||Standard Error|Mean
2817978|NCT00396981|Secondary|Target Aneurysm Recurrence||5 years||||participants|||Number
2817984|NCT00396981|Primary|Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.||12 months|A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.|||participants|||Number
2817985|NCT00396877|Secondary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the same population as previously (i.e. exposed population).|||participants|||Number
2817986|NCT00396877|Secondary|Number of Participants With Bleeding Events|"Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted."|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.|||participants|||Number
2817987|NCT00396877|Primary|Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)|"The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.~Only the first event was counted."|Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)|The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.|||participants|||Number
2817988|NCT00396812|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 48|ESR is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm/hr||Standard Deviation|Mean
2817989|NCT00396812|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 48|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker or wheelchair, or help is received from another person in the daily living activities. If an aid or device is used or help is received then a category score of 0 or 1 increases to a category score of 2. A category score of 3 remains a 3 regardless of aids, devices, or help. Scores from each of the 8 categories are totaled. The total score can range from 0 to 24. Change from baseline is computed as the total score at Week 48 minus the baseline total score. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
2817990|NCT00396812|Primary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
2817991|NCT00396812|Primary|Change From Baseline in Physician's Global Assessment of Patient's Disease Activity- Visual Analog Scale (PhGADA-VAS) at Week 48|Change from Baseline in PhGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm||Standard Deviation|Mean
2817992|NCT00396812|Primary|Change From Baseline in Patient's Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS) at Week 48|Change from Baseline in PtGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm||Standard Deviation|Mean
2817993|NCT00396812|Primary|Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 48|Change from Baseline in PAAP-VAS (0 to 100 millimeters visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||mm||Standard Deviation|Mean
2818567|NCT00394654|Secondary|Time to Observed Maximum Sputum Concentration (Tmax)|Tmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
2817994|NCT00396812|Primary|Change From Baseline in Swollen Joint Count at Week 48|Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
2817995|NCT00396812|Primary|Change From Baseline in Tender Joint Count Score at Week 48|Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Units on a scale||Standard Deviation|Mean
2817996|NCT00396812|Primary|Change From Baseline in the Disease Activity Score- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28-ESR is a score on a scale (0 to 10) that is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR (mm/hour). Lower score indicates less disease activity. Flares in disease activity are defined as an increase in this score of greater than 1.2 and remission is defined as achieving a DAS28-ESR score of less than 2.6.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits|||Score on a scale||Standard Deviation|Mean
2817997|NCT00396656|Secondary|Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Meters per second||Standard Deviation|Mean
2817998|NCT00396656|Secondary|Arterial Pressure Waveform Augmentation Index at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Ratio||Standard Deviation|Mean
2817999|NCT00396656|Secondary|Mean Post-treatment Microcirculation at NaCl Injected Sites|10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
2818000|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites|10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
2818001|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
2818002|NCT00396656|Primary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.|||Perfusion units||Standard Deviation|Mean
2818194|NCT00395746|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
2818004|NCT00396630|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any doses.|The analyses were performed on the Total Vaccinated Cohort|||subjects|||Number
2818005|NCT00396630|Secondary|Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.|"GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.~RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA)."|Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.|The analyses were performed on the Total Vaccinated Cohort|||subjects|||Number
2818006|NCT00396630|Secondary|Anti-rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.|||U/mL||95% Confidence Interval|Geometric Mean
2818007|NCT00396630|Secondary|Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.|Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.|||subjects|||Number
2818008|NCT00396630|Secondary|Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.|Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.|During the entire study period (up to Visit 4, Week 17).|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins who received placebo in case of transmission.|||Subjects|||Number
2818009|NCT00396630|Secondary|Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.|Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.|During the entire study period (up to Visit 4, Week 17).|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins who received placebo and those who received Rotarix vaccine, in case of transmission.|||Genetic variation difference|||Number
2818010|NCT00396630|Secondary|Duration of Human Rotavirus (HRV) Shedding Per Study Group.|Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.|From Day 0 up to Week 13.|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins whose placebo recipient had at least one stool sample positive for the rotavirus strain.|||Number of days||Inter-Quartile Range|Median
2818011|NCT00396630|Primary|Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.|Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.|On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.|||subjects|||Number
2818012|NCT00396591|Secondary|Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized|All participants who received at least part of 1 dose of the study treatment.|||participants|||Number
2818013|NCT00396591|Secondary|Number of Participants With a Positive Anti-drug Antibody Response|"Anti-drug antibodies in participant's serum were measured using 2 different methods~an Enzyme Linked Immunosorbent Assay (ELISA) in which the lower limit of detection (LLOD) was 238.4 ng/mL; and~an Electrochemiluminescence-based, Bridging Assay in which the validated LLOD was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.~Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response."|up to 60 days after the last dose of treatment|Participants who received at least part of 1 dose of aflibercept and had evaluable blood samples|||participants|||Number
2818014|NCT00396591|Secondary|Overall Survival (OS) Time|OS time was the time interval between the date of registration to the date of death from any cause. Median OS was estimated from Kaplan-Meier curves. Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.|up to 6 months post-registration|All participants were analyzed. 5 participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.|||days|Participants|95% Confidence Interval|Median
2818015|NCT00396591|Secondary|Progression-free Survival (PFS) Time|"According to the Response Evaluation Criteria in Solid Tumors [RECIST], progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.~PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~If participants were alive and progression-free at 6 months postregistration, they were censored for PFS."|up to 6 months post-registration|Participants with a PFS event (tumor progression or death) were analyzed.|||days||95% Confidence Interval|Median
2818016|NCT00396591|Secondary|60-day Frequency of Paracentesis (FOP)|FOP was the total number of paracenteses performed within the first 60 days postregistration. For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.|up to 60 days post-registration||||paracenteses||Standard Deviation|Mean
2818017|NCT00396591|Secondary|Time to Repeat Paracentesis (TRP)|TRP is the number of days between the date of registration and the date of the first postregistration paracentesis. Median TRP was estimated from Kaplan-Meier curves. For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.|up to 6 months from registration|All participants were analyzed. 8 had one or more paracentesis events. Participants with no paracentesis events were censored at the end of the treatment period (last dose + 1 cycle).|||days|Participants|95% Confidence Interval|Median
2818018|NCT00396591|Primary|Percentage of Participants With a Repeat Paracentesis Response (RPR)|"RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis).~Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants * 100."|up to 2 years post-registration||||percentage of participants||95% Confidence Interval|Number
2818019|NCT00396565|Secondary|Change From Baseline in Clinical Global Impression Scale (CGI-S)|The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Error|Mean
2818020|NCT00396565|Secondary|Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])|Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||Percentage of participants|||Number
2818021|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
2818022|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
2818023|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
2818024|NCT00396565|Primary|Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine (OLZ) group was set as an active drug group to examine clinical position of paliperidone (PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.|||scores on a scale||Standard Deviation|Mean
2818025|NCT00396409|Secondary|Lung Function as Assessed by Peak Expiratory Flow (PEF)|The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||liters per minute (L/min)||Standard Deviation|Mean
2818026|NCT00396409|Secondary|Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)|The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||milliliters (mL)||Standard Deviation|Mean
2818027|NCT00396409|Secondary|Work Productivity and Activity Impairment|The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2818028|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline|Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||participants|||Number
2818029|NCT00396409|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2818030|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2818031|NCT00396409|Secondary|Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2818032|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient|The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing').|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||percentage of participants|||Number
2818033|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator|The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1='excellent', 2='good', 3='moderate', 4='poor', 5='worsening' and (.)='missing').|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)|||percentage of participants|||Number
2818034|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Rescue Medication Score|Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient's entries in their diaries.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2818035|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Symptom Severity Score|The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
2818036|NCT00396409|Primary|Daily Symptom Load|The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT). The complete analysis population who consisted of all patients that received at least one dose of study drug was used for all efficacy and safety evaluations in this extension period.|||units on a scale||Standard Deviation|Mean
2818037|NCT00396383|Post-Hoc|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg|Number of participants achieving ≥ 2*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Total was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor|||participants|||Number
2818038|NCT00396383|Secondary|Number of Participants With a Durable Graft at 12 Months Post Transplantation|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.|Approximately month 13|Intent to treat population includes participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant.|||participants|||Number
2818039|NCT00396383|Secondary|Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment|Platelet (PLT) engraftment was defined as a PLT count of ≥ 20*10^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants. One participant did not have PLT samples collected (included as 'unknown' in data table).|||transplantations|Participants||Number
2818040|NCT00396383|Secondary|Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment|Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants.|||transplantations|Participants||Number
2818041|NCT00396383|Primary|Participant Counts of Summarized Adverse Events (AE) During Treatment|Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).|1 month|All participants who received plerixafor|||participants|||Number
2818042|NCT00396383|Primary|Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg|Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor|||participants|||Number
2818043|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 7-8 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng*h/mL||Standard Deviation|Mean
2818044|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 4 -5 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng*h/mL||Standard Deviation|Mean
2818045|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 7|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||Hours||Full Range|Median
2818046|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 4|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||Hours||Full Range|Median
2818047|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng/mL||Standard Deviation|Mean
2818048|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 4|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.|||ng/mL||Standard Deviation|Mean
2818049|NCT00396331|Secondary|Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 5*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.|||Participants|||Number
2818050|NCT00396331|Secondary|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 2*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.|||Participants|||Number
2818051|NCT00396331|Secondary|Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration|The number of participants with Bcl2 translocation in post-treatment samples.|Up to Day 7|"NHL participants with known follicular or transformed (follicular to diffuse large cell) lymphoma who provided samples for tumor cell mobilization analysis.~Outcome is not reported because there were insufficient samples for analysis."||||||
2818052|NCT00396331|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.|Day 5 to Day 11 (up to 7 aphereses)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had two courses of apheresis.|||Proportion of Participants|||Number
2818568|NCT00394654|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
2818053|NCT00396331|Secondary|Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation|The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT >50*10^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level >= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) > 1,000 (1*10^9/L) with no G-CSF for at least 1 week prior to the visit.|Approximately 13 months (12 months post transplant )|Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to >50*10^9/L and 1 who had low hemoglobin at the 12-month visit.|||Participants|||Number
2818054|NCT00396331|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The number of days from transplantation to successful engraftment as measured by platelet value of >=20*10^9/L for 7 days without transfusion.|Approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PLT engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Four transplants (2 in participants with NHL and 2 in participants with MM) did not result in PLT engraftment and are therefore not included in the analysis.|||Days|Participants|Full Range|Median
2818055|NCT00396331|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|The number of days from transplantation to successful engraftment as measured by PMN >=0.5*10^9 /L for 3 days or >=1.0*10^9 /L for 1 day.|approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.|||Days|Participants|Full Range|Median
2818056|NCT00396331|Primary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.|Day 5 to Day 11 (up to 7 apheresis)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had 2 courses of apheresis.|||Proportion of Participants|||Number
2818057|NCT00396331|Primary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately day 38|Safety population of all participants who received at least 1 dose of plerixafor.|||Participants|||Number
2818058|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period|||percentage of participants|||Number
2818059|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment (Dose 1 or Dose 2)|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818060|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818061|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818062|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818063|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818064|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818065|NCT00396318|Primary|Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818066|NCT00396292|Primary|Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin||anytime between baseline and the end of study or time to intervention|Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being <11.0 g/dL|||participants|||Number
2818067|NCT00396279|Secondary|Number of Participants With Anti-Denosumab Antibodies|Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.|From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.|Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.|||participants|||Number
2818068|NCT00396279|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.|From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months|All participants who received at least 1 dose of denosumab.|||participants|||Number
2818069|NCT00396279|Secondary|Serum Denosumab Trough Concentrations|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.|The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.|||ng/mL||Standard Deviation|Mean
2818070|NCT00396279|Secondary|Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)|Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).|||percent change||Inter-Quartile Range|Median
2818071|NCT00396279|Secondary|Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine|Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).|||percent change||Inter-Quartile Range|Median
2818072|NCT00396279|Primary|Percentage of Participants With Giant Cell Tumor Response|A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent < 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.|From enrollment until 25 weeks|The efficacy analysis set included participants with a Baseline histology assessment and at least 1 postdose histology assessment from weeks 5-25; or a Baseline radiology assessment and at least 1 postdose radiology assessment from weeks 5-25. Evaluable participants had to be on study for at least 28 days after administration of the first dose.|||percentage of participants||95% Confidence Interval|Number
2818073|NCT00396266|Secondary|Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor|A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).|Day 4 (10 hours post first plerixafor dose)|Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.|||ratio||Full Range|Median
2818074|NCT00396266|Secondary|Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients|Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||mL||Standard Deviation|Mean
2818075|NCT00396266|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.|||participants|||Number
2818195|NCT00395746|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
2818076|NCT00396266|Secondary|Single-dose Apparent Clearance of Plerixafor (CL/F)|Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||mL/hour||Standard Deviation|Mean
2818077|NCT00396266|Secondary|Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10)|Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||ng•h/mL||Standard Deviation|Mean
2818078|NCT00396266|Secondary|Single-dose Half-life of Plerixafor (T1/2)|Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||hours||Standard Deviation|Mean
2818079|NCT00396266|Secondary|Single-dose Time to Maximum Concentration of Plerixafor (Tmax)|Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||hours||Full Range|Median
2818080|NCT00396266|Secondary|Single-dose Maximum Observed Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).|||ng/mL||Standard Deviation|Mean
2818081|NCT00396266|Secondary|Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment|In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation.|Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.|This analysis was not performed due to sample degradation.||||||
2818082|NCT00396266|Secondary|Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population of participants who had transplants. One participant received a tandem transplant.|||number of transplants|Participants||Number
2818083|NCT00396266|Secondary|Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells|To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.|Time 0 to 11 hours after the first dose of plerixafor|"The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).~One participant excluded from the analysis because data was missing."|||participants|||Number
2818084|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of HD at Visit 2|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 2 - BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1).|Subjects in the MITT Population Treated with Extended-Dwell Tenecteplase at Visit 1|||mL/minute||Standard Deviation|Mean
2818085|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3|"Patients who experienced treatment failure at the end of Visit 1 and were eligible for and treated with extended-dwell tenecteplase at Visit 1 were assessed for Urea Reduction Ratio (URR) at Visits 2 and 3. URR was calculated from blood urea nitrogen (BUN) measurements according to the following:~(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|Blood urea nitrogen measurements were taken prior to HD and at the end of HD at Visits 2 (2nd HD session, within 72 hours after visit 1) and 3 (3rd HD session, within 72 hours of Visit 2)|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.|||percentage of participants||95% Confidence Interval|Number
2818086|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2|Patients who failed treatment at Visit 1 and were treated with extended-dwell tenecteplase were analyzed for Treatment Success at Visit 2. Treatment success at Visit 2 was defined as a BFR ≥ 300 mL/min, without line reversal, and increase of ≥ 25 mL/min from baseline BFR, at an associated target arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of HD and at the end of HD.|BFR was measured 30 minutes before the end of HD and at the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). Baseline BFR was measured at the beginning of HD at Visit 1.|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.|||percentage of participants||95% Confidence Interval|Number
2818087|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 1 - BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 1.|Modified intent to treat (MITT) population|||mL/min||Standard Deviation|Mean
2818088|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2|"The urea reduction ratio (URR) at Visit 2 was calculated for those participants who did not receive extended-dwell tenecteplase at Visit 1 from measurements of blood urea nitrogen (BUN) as follows:~(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|At Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) samples for blood urea nitrogen measurements were taken prior to HD and after HD was completed.|Modified intent to treat (MITT) population who did not receive extended-dwell tenecteplase at Visit 1.|||percentage of participants||95% Confidence Interval|Number
2818148|NCT00396019|Primary|Number of Participants With Imaging Response in Strata 1 and 2|"A response was defined as a ≥20% reduction in the sum of the volume of the target plexiform neurofibroma ( PN) within 12 months confirmed by a follow-up MRI after ≥4 weeks."|MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study.||||participants|||Number
2818089|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1|"The urea reduction ratio (URR) was calculated from measurements of blood urea nitrogen (BUN) as follows:~(Pre-treatment BUN) − (Post-HD BUN) * 100% / (Pre-treatment BUN)~Pre-treatment URR was assessed within 30-60 minutes after the initiation of HD and does not represent a true baseline value."|At Visit 1 (first hemodialysis session in which treatment was administered) samples for blood urea nitrogen measurements were taken at the beginning of HD (prior to treatment administration) and after HD was completed.|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
2818090|NCT00396253|Secondary|Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3|For patients with treatment success at Visit 1 or Visit 2, maintenance of catheter function at subsequent visits was defined as a BFR ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated target arterial pressure in the range of 0 to -280 mmHg at the beginning of that HD session (within the first 30 minutes).|Maintenance BFR measurements were taken at the beginning of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) and Visit 3 (3rd consecutive HD session, within 72 hours of Visit 2).|Modified intent to treat (MITT) population, who had treatment success at Visit 1. The n equals the number of subjects who had treatment success at Visit 1 and had assessment of catheter function for the given visit or who had a missing assessment due to starting the Retreatment course.|||percentage of participants||95% Confidence Interval|Number
2818091|NCT00396253|Primary|Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase|The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.|From initial study drug administration to the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for patients who did not receive extended-dwell tenecteplase, from initial study administration to the start of Visit 2.|Modified intent to treat (MITT) population|||Events|||Number
2818092|NCT00396253|Primary|Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.|Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis.|Modified intent to treat (MITT) population, consisting of all enrolled patients who received at least one dose of study drug (tenecteplase).|||Percentage of participants|||Number
2818093|NCT00396201|Secondary|Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor|The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||mL||Standard Deviation|Mean
2818094|NCT00396201|Secondary|Apparent Clearance (CL/F) of Single-dose Plerixafor|Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).|Day 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||mL/hr||Standard Deviation|Mean
2818095|NCT00396201|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor|Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.|Days 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||ng*hr/mL||Standard Deviation|Mean
2818096|NCT00396201|Secondary|Half-life (T1/2) Following a Single Dose of Plerixafor|Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||hours||Standard Deviation|Mean
2818097|NCT00396201|Secondary|Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor|Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||hours||Standard Deviation|Mean
2818098|NCT00396201|Secondary|Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor|Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.|||ng/mL||Standard Deviation|Mean
2818099|NCT00396201|Secondary|Number of Participants With a Durable Graft at 12 Months|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.|13 months|Intent to treat population which included all participants who received plerixafor and had a transplant.|||participants|||Number
2818100|NCT00396201|Secondary|Number of Days Post Transplantation to Platelet (PLT) Engraftment|Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values.|||days||Full Range|Median
2818101|NCT00396201|Secondary|Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant.|||days||Full Range|Median
2818102|NCT00396201|Secondary|Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg|Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5*10^6 CD34+cells/kg|||participants|||Number
2818103|NCT00396201|Secondary|Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included.|||ratio||Standard Deviation|Mean
2818104|NCT00396201|Secondary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor.|||proportion of participants|||Number
2818105|NCT00396201|Secondary|Overall Participant Counts of Adverse Events During the Treatment Period|"Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.~See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious."|Day 0 - approximately day 38|Safety population consisting of all participants who received G-CSF and/or plerixafor.|||participants|||Number
2818106|NCT00396201|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to Day 9|Intent to treat population which included all participants who received plerixafor.|||proportion of participants|||Number
2818107|NCT00396162|Secondary|Mean Number of Days of Steroid Spray Use for Each Group||8 weeks||||days||Standard Deviation|Mean
2818108|NCT00396162|Secondary|Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks)|Mean number of days that antibiotics were used in the subgroup (placebo vs Probiotic arm)|At 8 weeks after baseline measures||||days||Standard Deviation|Mean
2818109|NCT00396162|Secondary|Side Effect Summary|Totals of all side effects for placebo group and treatment group over the course of the eight week trial (including patients who dropped from the study after baseline measurement). Individual categories of side-effects are listed in Adverse events section.|8 weeks|The sample size on the placebo side is reduced due to some study participants not reporting their 8 week survey|||participants|||Number
2818110|NCT00396162|Primary|Mean Reduction in SNOT-20 Scores|Mean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.|8 weeks||||units on a scale||Standard Deviation|Mean
2818111|NCT00396136|Primary|Safety of the COROX OTW Steroid LV Pacing Lead|Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.|3 years post implant|All study participants.|||participants|||Number
2818112|NCT00396136|Primary|Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing|Evaluate threshold voltage of the COROX OTW Unipolar Lead.|All follow-ups for 3 years post implant|All study participants.|||Threshold Voltage|Participants|Standard Deviation|Mean
2818113|NCT00396097|Secondary|Change From Baseline in Height SDS at 48 Months.|Change in height SDS was measured at 48 months.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2818114|NCT00396097|Secondary|Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months|The estimated cost of long-term height gain until FAH was calculated.|4 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||mg/cm||Standard Deviation|Mean
2818115|NCT00396097|Secondary|Computed Cost of Height Gain at 48 Months|The computed cost of height gain was defined as the amount of drug used relative to the observed height-gain, in terms of mg/cm, this was calculated at Month 48.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||mg/cm||Standard Deviation|Mean
2818116|NCT00396097|Secondary|Time Cost (Months Until >= -2 SDS)|Time cost was defined as the number of months needed until height SDS was within the normal limit (ie, >= -2SDS).|2 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available.|||Months||95% Confidence Interval|Median
2818117|NCT00396097|Secondary|Variability of Height SDS at 24 Months|The continuous endpoint of variability of height SDS at 24 months was defined as the SD of the 24 month height SDS.|2 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2818118|NCT00396097|Primary|Absolute On-target Difference (AOTD) at 24 Months|This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or -1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).|2 years|The Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. Last observation carried forward (LOCF) rule was applied to impute Month 24 missing height SDS data.|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2818119|NCT00396084|Secondary|Percent Dosing Interval Above Minimum Inhibitory Concentration (MIC)|Determined by linear extrapolation of concentration-versus-time curve to intersection with MIC.|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||Percentage||Inter-Quartile Range|Mean
2818120|NCT00396084|Secondary|Area Under the Curve (AUC) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC)|Area Under the Curve 0-12 (AUC 0-12) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC) and AUC 0-24/MIC|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/h/ml||Inter-Quartile Range|Median
2818121|NCT00396084|Secondary|Area Under the Curve (AUC) During First 12 and 24 Hours Adjusted for Free Drug Concentrations|Median pharmacodynamic parameters (range) adjusted for free drug concentrations. AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/h/ml||Inter-Quartile Range|Median
2818122|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC) Adjusted for Free Drug Concentrations||Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/ml||Inter-Quartile Range|Median
2818123|NCT00396084|Secondary|Maximum Plasma Drug Concentrations (Cmax), Adjusted for Free Drug Concentration|Cmax adjusted for free drug concentrations after 5 days of monotherapy with study drugs|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/ml||Full Range|Median
2818124|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve During First 12 and 24 Hours|Median pharmacokinetic parameters (range). AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/h/ml||Full Range|Median
2818125|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||hours||Full Range|Median
2818126|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum Plasma Drug Concentration (Cmax), given sampling scheme|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||ug/ml||Full Range|Median
2818127|NCT00396084|Secondary|Area Under the Curve During First 12 or 24 Hours / Minimum Inhibitory Concentration (AUC/MIC)|Area Under the Curve (AUC) During First 12 or 24 Hours /Minimum Inhibitory Concentration. AUC reflects total drug (bound and unbound). MIC values were determined using protein-containing media.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling|||ug/ml||Inter-Quartile Range|Median
2818128|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve (AUC) During First 12 and 24 Hours|Area under the curve (AUC), from time 0-12 hours for INH or 0-24 hours for gatifloxacin, levofloxacin, and moxifloxacin.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||ug/h/ml||Full Range|Median
2818129|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Linezolid Once Daily/Linezolid Twice Daily/INH Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|One patient in the INH arm discontinued the study drug after 5 days. Days 3 and 7 cultures for another patient in the INH arm were contaminated and cfu data are not available for this patient. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||log10 cfu/ml||Standard Deviation|Mean
2818130|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC)||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||ug/ml||Inter-Quartile Range|Median
2818131|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||hours||Full Range|Median
2818132|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum cfu (expressed in log10 units) during the first 2 days of monotherapy. Mean values for the 3 treatment groups were compared.|Day 0 to Day 2 Monotherapy|EBA 0-2 comparisons across groups were done for 29 patients. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.|||log10 cfu/ml/day||Standard Deviation|Mean
2818133|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming unit (cfu) for each day on treatment was calculated for patients in the INH arm and those in the Linezolid once daily and Linezolid twice daily arms. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 29 patients. One patient in the linezolid twice daily arm withdrew after randomization before receiving any doses of study drug.|||Percentage||Standard Deviation|Mean
2818134|NCT00396084|Primary|Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|A total of 38 patients were analyzed for Early Bactericidal Activity (EBA) Days 2-7. One patient in the moxifloxacin arm discontinued the study drug after 4 days. One patient in the INH arm discontinued the study drug after 6 days.|||log10 cfu/ml/day||Standard Deviation|Mean
2818135|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum colony forming units (cfu) (expressed in log10 units) during the first 2 days of monotherapy.|Day 0 to Day 2 Monotherapy|Early bactericidal activity (EBA 0-2) was calculated for 10 subjects per treatment arm (n=40).|||log10 cfu/ml/day||Standard Deviation|Mean
2818136|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum plasma concentration, given sampling scheme|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.|||ug/ml||Full Range|Median
2818137|NCT00396084|Secondary|Sputum Cytokine Proteins - Results Are Pending.||Study drug administration duration|||||||
2818138|NCT00396084|Secondary|Sputum mRNA Clearance Rate - Results Are Pending.||Study drug administration duration|||||||
2818139|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 10 subjects per treatment arm (n=40).|||Percentage||Standard Deviation|Mean
2818140|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with open-label tenecteplase at Visit 2|||percentage of success|||Number
2818141|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with extended-dwell tenecteplase at Visit 1|||percentage of success|||Number
2818142|NCT00396032|Secondary|Change in BFR From Baseline to the End of HD at Visit 1|BFR is measured in mL/minute.|Visit 1 of HD treatment|MITT population|||percentage of participants|||Number
2818143|NCT00396032|Primary|Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2|Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications|Visits 1 and 2 of consecutive HD treatments|MITT population|||percentage of participants|||Number
2818144|NCT00396032|Primary|Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 1 of HD treatment|Modified intent to treat (MITT) population|||percentage of success|||Number
2818145|NCT00396019|Secondary|Number of Participants With Imaging Response in Stratum 3|"A Response was defined as a ≥ 20% reduction in the sum of the volume of the target plexiform neurofibroma (PN) within 12 months, confirmed by a follow-up MRI after ≥ 24 weeks"|MRI scans were performed at baseline and at months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study||||participants|||Number
2818146|NCT00396019|Primary|Time to Progression (TTP) in Stratum 3|TTP was estimated by the Kaplan-Meter method|baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study|Only participants in Stratum 3 contributed data for this Outcome Measure|||months||Full Range|Median
2818147|NCT00396019|Primary|Clinical Response in Stratum 2|Clinical response was defined as a protocol-specified improvement in ophthalmologic evaluation, an improvement of at least one level in performance status (PS) ≥50% decrease in the amount of pain medications required per week compared with baseline or ability to change from a narcotic to a nonnarcotic analgesic, sustained for at least one month.|baseline, week 6, months 4, 8, 12, 18, and 24 while on treatment and every 6 months thereafter until off study|Only participants in Stratum 2 contributed data for this Outcome Measure|||participants|||Number
2828341|NCT00316017|Secondary|Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28|Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28|28 days from time of ED arrival||||participants|||Number
2818149|NCT00396006|Secondary|Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion|"Clinically significant changes in vital signs from pre- to post-infusion are:~Heart rate: 25% increase above pre-infusion value~Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic)~Temperature: an increase in body temperature to >38°C (>100.4°F). If the pre-infusion body temperature was already >38°C (>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant.~Respiratory rate: 25% increase above pre-infusion value"|During 8 consecutive weeks of infusion|Intention to treat|||# Clinically significant events|||Number
2818150|NCT00396006|Primary|Number of Changes in the Rate of Infusion|Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min|During 8 consecutive weeks of treatment||||infusions|||Number
2818151|NCT00396006|Other Pre-specified|Change in the BAL ELF Tumor Necrosis Factor-alpha (TNF-α) From Baseline to Post-treatment|Median change in the BAL ELF TNF-α from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures||||||
2818152|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Interleukin 8 (IL-8) Level|Median ratio of post- to pre-treatment BAL ELF IL-8 Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||pg/mL||Full Range|Median
2818153|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level|Median ratio of post- to pre-treatment BAL ELF Total Neutrophil Elastase Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||nM||Full Range|Median
2818154|NCT00396006|Other Pre-specified|Change in the BAL ELF Free Neutrophil Elastase Level|Median change in the BAL ELF Free Neutrophil Elastase Level from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures|||nM||Full Range|Median
2818155|NCT00396006|Secondary|Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level|Mean change in the plasma ANEC level from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol|||μM||Standard Deviation|Mean
2818156|NCT00396006|Secondary|Change in the α1-PI Plasma Level|Mean change in the plasma level of α1-PI from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol|||μM||Standard Deviation|Mean
2818157|NCT00396006|Secondary|Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration|Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|No per protocol subject had both pre- and post-treatment analytes available, therefore no analysis could be performed on this outcome measure||||||
2818158|NCT00396006|Secondary|Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels|Median ratio of post- to pre-treatment BAL ELF ANEC levels|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||μM||Full Range|Median
2818159|NCT00396006|Primary|The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min||During 8 consecutive weeks of treatment|Intent to treat|||adverse events|||Number
2818160|NCT00396006|Primary|Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level|Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol|||μM||Full Range|Median
2818161|NCT00395993|Primary|Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL||Any time between baseline and the end of study or time to intervention|Modified Intent-to-Treat Population defined as subjects from the Safety Population who received at least 1 dose of study medication, had average baseline hemoglobin, TSAT, and ferritin levels, had heavy uterine bleeding, and had at least 1 post-baseline hemoglobin assessment.|||participants|||Number
2818162|NCT00395967|Secondary|Graft Durability at 12 Months After Transplantation|"Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.~This study was terminated early and analysis was not done."|13 months|This study was terminated early and analysis was not done.||||||
2818163|NCT00395967|Secondary|Number of Days to Platelet (PLT) Engraftment|"The median number of days to platelet (PLT) engraftment criteria was ≥ 20*10^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.~This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.||||||
2818164|NCT00395967|Secondary|Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|"The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.~This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.||||||
2818165|NCT00395967|Secondary|The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor|"The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).~This study was terminated early and analysis was not done."|Days 5-6|This study was terminated early and analysis was not done.||||||
2818166|NCT00395967|Secondary|Overall Participants Counts of Adverse Events|Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|up to 13 months|Safety Population defined as all participants who received G-CSF and/or plerixafor.|||participants|||Number
2829965|NCT00302159|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years, 7 months and 27 days||||participants|||Number
2818167|NCT00395967|Primary|Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days|The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.|approximately days 6-9|All patients who received plerixafor.|||participants|||Number
2818168|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period|||Percentage of patients||95% Confidence Interval|Number
2818169|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
2818170|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after third dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
2818171|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after third dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
2818172|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after third dose|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
2818173|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
2818174|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population|||Percentage of patients||95% Confidence Interval|Number
2818175|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population|||percentage of participants||95% Confidence Interval|Number
2818176|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population|||Percentage of patients|||Number
2818177|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818178|NCT00395876|Primary|Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population|||percentage of participants|||Number
2818179|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 3|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[percent]|Participants|Standard Deviation|Mean
2818569|NCT00394654|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 27, 55, 84, and 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2818180|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 2|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[percent]|Participants|Standard Deviation|Mean
2818181|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 1|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[percent]|Participants|Standard Deviation|Mean
2818182|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
2818183|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
2818184|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
2818185|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
2818186|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
2818187|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.|||[ratio]|Participants|Standard Deviation|Mean
2818188|NCT00395863|Secondary|Lesion Contrast Enhancement Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.|||Contrast-enhanced Images|Participants||Number
2818189|NCT00395863|Secondary|Lesion Border Delineation|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.|||Contrast-enhanced Images|Participants||Number
2818190|NCT00395863|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.|||Contrast-enhanced Images|Participants||Number
2818191|NCT00395850|Secondary|Retention||14 weeks|those who were entered the disulfiram phase,e tc.|||Weeks||Standard Deviation|Mean
2818192|NCT00395850|Primary|Cocaine Use Over Time|Urine toxicology results (dichotomous: positive or negative) for the presence of cocaine/cocaine metabolite during the disulfiram phase of the study. The change in the probability of a cocaine positive urine sample per day was assessed for each dose compared with placebo and slopes for each dose condition were calculated from Repeated Measures Genearlized Linear Models on a Binomial distribution (thus a Repeated Measures Logistic Regression)|thrice weekly for 12 weeks|number is based on those who participated long enough to have assessments completed at two time points during the disulfiram phase|||slope (change in prob of coc-pos utox/d)|||Number
2818193|NCT00395746|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.|||number of events per year of exposure|||Number
2818570|NCT00394654|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2818196|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818197|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818198|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818199|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818200|NCT00395746|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
2818201|NCT00395746|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
2818202|NCT00395746|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818203|NCT00395746|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818204|NCT00395746|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
2818205|NCT00395746|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
2818206|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 3|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Vessels|||Number
2818207|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 2|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Vessels|||Number
2818314|NCT00395512|Secondary|Change From Baseline in Triglyceride Levels|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818208|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 1|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Vessels|||Number
2818209|NCT00395733|Secondary|MRA Diagnosis by Investigators|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.|||Vessels|||Number
2818210|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3|Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Participants|||Number
2818211|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2|Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Participants|||Number
2818212|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1|Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||Participants|||Number
2818213|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator|The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.|||Participants|||Number
2818214|NCT00395733|Primary|Number of Vessel Segments Visualized With Diagnostic Quality|Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.|||vessel segments||Standard Deviation|Mean
2818215|NCT00395694|Secondary|Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8|Monocytes are a type of white blood cell (WBC; typically comprising 2%-8% of total WBCs) and are a part of the immune system. The normal range for adults is 0.2 to 0.95 * 10^3 cells per microliter (µL); the normal range for adolescents is 0 to 0.8 * 10^3 cells per µL. The monocyte count may increase during chronic inflammation, stress response, immune-mediated disease, viral fever, etc. The percentage of participants (par.) with monocyte values outside the normal range was calculated as 100 * (number of par. with monocyte values outside the normal range) divided by the total number of par.|Week 4 and Week 8|Safety Population|||percentage of participants|||Number
2818216|NCT00395694|Secondary|Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA|The rash adjudication committee reviewed all rash events from a dermatologic standpoint based on the nature, onset site, affected area, time to onset, outcome, and the investigator's comments to adjudicate whether or not the reported event was a drug eruption. A drug eruption is an eruption or a solitary lesion caused by a drug taken internally, often a result of allergic sensitization.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||adjudicated rash events|total rash events||Number
2818217|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
2818571|NCT00394654|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)|||Participants|||Number
2818218|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||participants|||Number
2818219|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
2818220|NCT00395694|Secondary|Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population|||participants|||Number
2818221|NCT00395694|Secondary|Percent Change in Seizure Frequency of the Indicated Types of Seizures|Percent change in seizure frequency was calculated as 100 * (pre-treatment seizures minus MP seizures)/pre-treatment seizures. Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types, mental retardation or regression, and abnormal findings on an ECG.|Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)|FAS Population|||percent change||95% Confidence Interval|Median
2818222|NCT00395694|Secondary|Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures|Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on an electroencephalogram (EEG), with paroxysms of fast activity and generalized slow spike-and-wave discharges.|8 weeks|Full Analysis Set (FAS) Population: all enrolled participants except those who had no assessments of the main efficacy variable (percent reduction in seizure frequency).|||percentage of participants|||Number
2818223|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
2818224|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.|||participants|||Number
2818225|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.|||rash events|||Number
2818226|NCT00395694|Primary|Number of Participants With Any Rash Event (Including Stevens-Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population: all participants enrolled in the study who received at least one dose of study medication|||participants|||Number
2818315|NCT00395512|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818227|NCT00395642|Primary|Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.|Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.|6 months|All Enrolled Participants|||Percent of days|||Number
2818228|NCT00395629|Secondary|Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)|A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.|4, 8, 12, 16, 20, and 24 weeks|Per-protocol population included all participants of the safety population; who received at least one dose of study drug within the core study and had at least one safety assessment, and who did not have any major protocol deviation. n in each of the Categories is the number of participants in each arm/group who had data for that time point.|||µmol/L||Standard Deviation|Mean
2818229|NCT00395629|Primary|Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)|Mean absolute change in serum ferritin from baseline to the end of the extension study.|0 to 48 weeks|Extension Per-protocol population including all participants of the per protocol population who also were part of the extension safety population.|||µg/L||Standard Deviation|Mean
2818230|NCT00395538|Secondary|Z-score of Whole Body Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Whole Body BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 6-months after start of HPTH, last visit on HPTH, and post-HPTH follow-up visits|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||z-score||Standard Error|Mean
2818231|NCT00395538|Secondary|Z-score of Total Hip Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Total Hip BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 6-months after start of HPTH, last visit on HPTH, and post-HPTH follow-up visits|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||z-score||Standard Error|Mean
2818232|NCT00395538|Secondary|Z-score of Lateral Spine Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Lateral Spine BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA . The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 6-months after start of HPTH, last visit on HPTH, and post-HPTH follow-up visits|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||z-score||Standard Error|Mean
2818233|NCT00395538|Secondary|Z-score of Femoral Neck Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Femoral BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 6-months after start of HPTH, last visit on HPTH, and post-HPTH follow-up visits|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||z-score||Standard Error|Mean
2818256|NCT00395538|Secondary|Raw Whole Body Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Whole Body BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||g/cm^2||Standard Error|Mean
2818234|NCT00395538|Secondary|Z-score of AP Spine Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The AP Spine BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 6-months after start of HPTH, last visit on HPTH, and post-HPTH follow-up visits|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||z-score||Standard Error|Mean
2818235|NCT00395538|Secondary|Z-score of 1/3 Radius Bone Mineralization Density (BMD) Assessed by DXA.|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit The 1/3 Radius BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||z-score||Standard Error|Mean
2818236|NCT00395538|Secondary|Sensitivity Analyses of Female Menopause Status in the Primary Bone Biopsy Efficacy Models|As a sensitivity analysis, the 8 primary bone biopsy measures were to be adjusted for female menopausal status, by fitting the primary bone biopsy model with a menopausal status covariate added to the model. However, the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively. Furthermore, 3 males would need to be removed from the model leaving 4, 3, 2 participants with bone biopsies with an additional degree of freedom consumed for the menopausal status covariate. Thus, the planned mixed models analysis was not performed since with such small samples sizes random fluctuations in the data could give misleading erroneous results.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.||||||
2818237|NCT00395538|Secondary|Primary Bone Biopsy Measures Adjusted for HPTH Dose|The 8 primary bone biopsy measures were to be adjusted HPTH dose by fitting the primary bone biopsy model with both linear and quadratic dose covariates added to the model. However, the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively. To add additional linear and quadratic dose covariates to the statistical model with an already small sample sizes would highly risk over-parameterizing the model. Thus no new analysis was performed.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.||||||
2818238|NCT00395538|Secondary|Number of Participants With Nephrolithiasis/Nephrocalcinosis|Participants had ultrasound and CT imaging of the kidney were performed yearly. The rates of new, stable, and progressing nephrocalcinosis and nephrolithiasis (NCNL) were recorded.|Baseline, 12-Month Visit, 24-Month Visit, 36-Month Visit, 48-Month Visit, and 60-Month Visit|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||Participants|||Count of Participants
2818239|NCT00395538|Secondary|24 Hour Urine NTX Telopeptide|Urine was collected over 24 hours and the total NTX Telopeptide measured|Baseline, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||nmol Bone Collagen Equiv/mmol Creatinine||Standard Error|Mean
2818240|NCT00395538|Secondary|Serum Phosphorus|Serum Phosphorus concentration|Baseline, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||mg/dL||Standard Error|Mean
2818241|NCT00395538|Secondary|Serum Osteocalcin|Serum Osteocalcin concentration|Baseline, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||ng/mL||Standard Error|Mean
2818242|NCT00395538|Secondary|Serum Calcium|Serum Calcium concentration|Baseline, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||Mmol/L||Standard Error|Mean
2818243|NCT00395538|Secondary|Serum Alkaline Phosphatase|Serum Alkaline Phosphatase concentration|Baseline, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||ug/L||Standard Error|Mean
2818244|NCT00395538|Secondary|SF36 Vitality Domain|Vitality (VT) Domain scores are derived from the SF36 Health Survey taken by the participant. SF36 domain scores are scaled to have a population mean of 50 and a standard deviation of 10. Higher scores reflect a better quality of life.The SF-36 is a validated questionnaire assessing 4 physical components: physical function, physical role limitations, bodily pain, and general health, and 4 mental components: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool is used to calculate the eight domain scores. The scoring tool transforms the score into a 0-100 scale on the assumption that each question carries equal weight. SF36 domain scores are scaled to have a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The VT Domain assesses the participant's experience of feeling energetic and full of pep, or worn out and tired.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818245|NCT00395538|Secondary|SF36 Social Function Domain|Social Function (SF) Domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical components: physical function, physical role limitations, bodily pain, and general health, and 4 mental components: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool is used to calculate each of the eight domain scores. The scoring tool transforms the score into a 0-100 scale on the assumption that each question carries equal weight. SF36 domain scores are scaled to have a population mean of 50 and a standard deviation of 10. The SF Domain assesses the level of a participant's social activities and interaction with significant others such as family members, friends, neighbours and other social relations. Lower scores indicate more disability; higher scores indicate less disability with respect to social function.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818246|NCT00395538|Secondary|SF36 Physical Role Limitations Domain|Physical Role Limitations (RP) Domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical domains: physical function, physical role limitations, bodily pain, and general health, and 4 mental domains: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool derives SF36 domain scores for each of the eight domains. These domain scores are scaled to range from 0 to 100 with a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The RP Domain assesses the extent to which a participant's' performance of his/her roles in daily activities is impeded by his/her physical state of health.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818247|NCT00395538|Secondary|SF36 Physical Function Domain|Physical Function (PF) Domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical domains: physical function, physical role limitations, bodily pain, and general health, and 4 mental domains: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool derives SF36 domain scores for each of the eight domains. These domain scores are scaled to range from 0 to 100 with a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The PF domain assesses the extent to which the participant's perceptions of his/her ability to perform vigorous and moderate physical activities are influenced by his/her physical condition.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818248|NCT00395538|Secondary|SF36 Mental Health Domain|Mental Health (MH) Domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical domains: physical function, physical role limitations, bodily pain, and general health, and 4 mental domains: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool derives SF36 domain scores for each of the eight domains. These domain scores are scaled to range from 0 to 100 with a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The MH domain assesses the extent to which the participant is, among other things, feeling full of pep, is happy, is feeling calm and peaceful, is very nervous, or is feeling worn out and tired.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818257|NCT00395538|Secondary|Raw Total Hip Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Total Hip BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||g/cm^2||Standard Error|Mean
2818249|NCT00395538|Secondary|SF36 General Health Domain|General Health (GH) Domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical domains: physical function, physical role limitations, bodily pain, and general health, and 4 mental domains: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool derives SF36 domain scores for each of the eight domains. These domain scores are scaled to range from 0 to 100 with a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The GH domain score assesses a participant's perception of their general health in terms of concepts such as excellent, very good, good, fair or poor, getting ill easier than other people, and just as healthy as anyone he/she knows.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818250|NCT00395538|Secondary|SF36 Emotional Role Limitations Domain|Emotional Role Limitations (RE) Domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical domains: physical function, physical role limitations, bodily pain, and general health, and 4 mental domains: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool derives SF36 domain scores for each of the eight domains. These domain scores are scaled to range from 0 to 100 with a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The RE Domain score assesses the extent to which the emotional condition of the participant, e.g. feeling depressed or anxious, limits his/her daily functioning and ability to perform roles, such as in cutting down on the amount of time spent on work or other activities and accomplishing less than he/she would like to.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818251|NCT00395538|Secondary|SF36 Bodily Pain Domain|The Bodily Pain (BP) domain scores are derived from the SF36 Health Survey taken by the participant. The SF-36 is a validated questionnaire assessing 4 physical domains: physical function, physical role limitations, bodily pain, and general health, and 4 mental domains: vitality, emotional role limitations, social function and mental health. From the 36 questions asked, a scoring tool derives SF36 domain scores for each of the eight domains. These domain scores are scaled to range from 0 to 100 with a population mean of 50 and a standard deviation of 10. Lower scores indicate more disability; and, higher scores indicate less disability. The BP domain scores indicate to what extent a participant's bodily pain hinders their performance of daily activities.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818252|NCT00395538|Secondary|Total Distance Walked During a 6-minute Walk|The total distance a participant was able to walk during a 6-minute walk|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||Distance in meters||Standard Error|Mean
2818253|NCT00395538|Secondary|Composite Severity Score of the Fatigue Symptom Inventory (FSI)|Severity is measured using four separate items of the FSI questionnaire that assesses how the participant felt on their most, least, and average fatigue days in the past week as well as current fatigue. Participants score their level of fatigue for each item on an 11-point scale (0=not at all fatigued, 10=as fatigued as I could be). The composite severity score reflects the sum of these 4 scores. The composite severity scores can range from 0 to 40. A higher composite severity scores indicates that the participant is experiencing more severe fatigue.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||Composite score from the FSI||Standard Error|Mean
2818254|NCT00395538|Secondary|Average Severity Score of the Fatigue Symptom Inventory (FSI)|Severity is measured using four separate items of the FSI questionnaire that assesses how the participant felt on their most, least, and average fatigue days in the past week as well as current fatigue. Participants score their level of fatigue for each item on an 11-point scale (0=not at all fatigued, 10=as fatigued as I could be). An average is taken of sum of these 4 scores. The average severity score can range from 0 to 10. A higher average severity score indicates that the participant is experiencing more severe fatigue.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818255|NCT00395538|Secondary|Perceived Interference (PI) of the Fatigue Symptom Inventory (FSI)|Perceived interference is measured using seven separate items that assess the degree to which fatigue in the past week was judged to interfere with general level of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. The interference ratings were summed to yield a total interference score ranging from 0 (no perceived interference due to fatigue) to 70 (maximum possible perceived interference due to fatigue).|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||score on a scale||Standard Error|Mean
2818258|NCT00395538|Secondary|Raw Lateral Spine Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Lateral Spine BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA .|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||g/cm^2||Standard Error|Mean
2818259|NCT00395538|Secondary|Raw Femoral Neck Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The Femoral BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||g/cm^2||Standard Error|Mean
2818260|NCT00395538|Secondary|Raw AP Spine Bone Mineralization Density (BMD) Assessed by DXA|The DXA BMD were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit. The AP Spine BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||g/cm^2||Standard Error|Mean
2818261|NCT00395538|Secondary|Raw 1/3 Radius Bone Mineralization Density (BMD) Assessed by DXA.|The DXA BMD measures were assessed every 6 months over 5 years, and at a follow-up visit post-HPTH therapy. Due to varying lengths of time on each participant was on HPTH, these BMD assessment times were collapsed for purposes of analysis to: baseline, 6-month on HPTH therapy, last visit on HPTH therapy, and the post-HPTH follow-up visit The 1/3 Radius BMD is one of 6 bone regions measurements of bone mineralization density assessed by DXA.|Baseline, 6-months after start of HPTH, last visit on HPTH (up to 5 years), and post-HPTH follow-up visit (6 months post last visit on HPTH)|Secondary Efficacy Population: This population consists of all participants who received at least one dose of HPTH and had at least one post-baseline non-biopsy efficacy assessment. This population will only include participants in Cohorts 2 and 3.|||g/cm^2||Standard Error|Mean
2818262|NCT00395538|Secondary|Change in Cortex 1 Spectral Calcium High From the Back-Scattered Electron Imaging of Bone-Biopsies|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. The Cortex 1 Spectral Calcium High is a measure of the area of high bone cortex 1 mineralization based on the mineralization density distribution (BMDD) from the back-scattered electron imaging scan of the bone biopsies. The changes in Ic.MAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||Percentage of the region of interest||Standard Error|Least Squares Mean
2818263|NCT00395538|Secondary|Change in Cortex 1 Spectral Calcium Low From the Back-Scattered Electron Imaging of Bone-Biopsies|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. The Cortex 1 Spectral Calcium Low is a measure of the area of low bone cortex 1 mineralization based on the mineralization density distribution (BMDD) from the back-scattered electron imaging scan of the bone biopsies. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||Percentage of the region of interest||Standard Error|Least Squares Mean
2818306|NCT00395512|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818307|NCT00395512|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818264|NCT00395538|Secondary|Change in Cortex 1 Spectral Calcium Width From the Back-Scattered Electron Imaging of Bone-Biopsies|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. The Cortex 1 Spectral Calcium Low is a measure of the area of low bone cortex 1 mineralization based on the mineralization density distribution (BMDD) from the back-scattered electron imaging scan of the bone biopsies. The changes in Ic.MAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||Percentage of the region of interest||Standard Error|Least Squares Mean
2818265|NCT00395538|Secondary|Change in Cortex 1 Spectral Calcium Peak From the Back-Scattered Electron Imaging of Bone-Biopsies|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. The Cortex 1 Spectral Calcium Peak is a measure of the most frequent calcium content of the bone cortex 1 based on the bone mineralization density distribution (BMDD) from the back-scattered electron imaging scan of the bone biopsies. The changes in Ic.MAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||Percentage of the region of interest||Standard Error|Least Squares Mean
2818266|NCT00395538|Secondary|Change in Cortex 1 Spectral Calcium Mean From the Back-Scattered Electron Imaging of Bone-Biopsies|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. The Cortex 1 Spectral Calcium Mean is a measure of mean bone calcium content of the bone cortex 1 based on the mineralization density distribution (BMDD) from the back-scattered electron imaging scan of the bone biopsies. The changes in Ic.MAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||Percentage of the region of interest||Standard Error|Least Squares Mean
2818267|NCT00395538|Secondary|Change in Intracortical Adjusted Apposition Rate (Ic.AjAR)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.AjAR is one of 21 secondary endpoints measured from the bone biopsy. Ic.AjAR represents the intracortical mineral apposition rate (Ic.MAR) averaged over the the entire osteoid surface. This is another histomorphometric way to evaluate the rate at which bone is laid down within the middle of the cortex per day. The changes in Ic.AjAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline values)|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um/d||Standard Error|Least Squares Mean
2818268|NCT00395538|Secondary|Change in Intracortical Eroded Surface / Bone Surface (Ic.ES/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.ES/BS is measured from the bone biopsy. This measure demonstrates the percentage of bone surface within the middle of the cortex that is resorbed (eroded). The region of interest is the predefined area of total bone that is being measured. The changes in Ic.ES/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818308|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2825125|NCT00343564|Secondary|Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
2818269|NCT00395538|Secondary|Change in Intracortical Osteoid Surface / Bone Surface (Ic.OS/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.OS/BS measured from the bone biopsy. This measure demonstrates the percentage of the intracortical bone surface that is not mineralized (osteoid). The region of interest is the predefined area of total bone that is being measured. The changes in OS/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818270|NCT00395538|Secondary|Change in Intracortical Bone Mineral Apposition Rate (Ic.MAR)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.MAR is measured from the bone biopsy. This measures the rate mineral is being laid down per day within the middle of the cortex (intracortical) surface in a predefined region of cortical bone. The changes in Ic.MAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um/d||Standard Error|Least Squares Mean
2818271|NCT00395538|Secondary|Change in Intracortical Osteoid Thickness (Ic.O.Th)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.O.Th is one of 21 secondary endpoints measured from the bone biopsy. This measures the thickness of the unmineralized bone (osteoid) within the middle of the cortex (intracortical). The changes in Ic.O.Th between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um||Standard Error|Least Squares Mean
2818272|NCT00395538|Secondary|Change in Endocortical Adjusted Apposition Rate (Ec.AjAR)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ec.AjAR is measured from the bone biopsy. Ec.AjAR represents the endocortical mineral apposition rate (Ec.MAR) averaged over the entire osteoid surface. This is another histomorphometric way to evaluate the rate at which bone is laid down on the inner cortical surface per day. The changes in Ec.AjAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um/d||Standard Error|Least Squares Mean
2818273|NCT00395538|Secondary|Change in Endocortical Eroded Surface / Bone Surface (Ec.ES/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4- year biopsies were collapsed into one biopsy year group. Ec.ES/BS is measured from the bone biopsy. This measure demonstrates the percentage of the endocortical bone surface that is resorbed (eroded). The region of interest is the predefined area of total bone that is being measured. The changes in Ec.ES/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818309|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818330|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818274|NCT00395538|Secondary|Change in Endocortical Osteoid Surface / Bone Surface (Ec.OS/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ec.OS/BS is measured from the bone biopsy. This measures the rate mineral is being laid down per day on the inner cortical (endocortical) surface in a predefined region of cortical bone. The changes in Ec.OS/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818275|NCT00395538|Secondary|Change in Endocortical Bone Mineral Apposition Rate (Ec.MAR)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose.Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ec.MAR is measured from the bone biopsy. This measures the rate mineral is being laid down per day on the inner cortical (endocortical) surface in a predefined region of cortical bone. The changes in Ec.MAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um/d||Standard Error|Least Squares Mean
2818276|NCT00395538|Secondary|Change in Endocortical Osteoid Thickness (Ec.O.Th)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ec.O.Th is measured from the bone biopsy. This measures the thickness of the unmineralized bone (osteoid) on the inner side of the cortex(endocortical). The changes in Cn.AjAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um||Standard Error|Least Squares Mean
2818277|NCT00395538|Secondary|Change in Cancellous Adjusted Apposition Rate (Cn.AjAR)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.AjAR is measured from the bone biopsy. Cn.AjAR represents the Cn.MAR averaged over the entire osteoid surface.The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes. The changes in Cn.AjAR between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818278|NCT00395538|Secondary|Change in Cancellous Eroded Surface / Bone Surface (Cn.ES/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.ES/BS is measured from the bone biopsy. This measure demonstrates the percentage of the cancellous bone surface that contains unmineralized bone (osteoid). The region of interest is the predefined area of total bone that is being measured. The changes in Cn.ES/BS between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818310|NCT00395512|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
2818311|NCT00395512|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
2818279|NCT00395538|Secondary|Change in Cancellous Osteoid Surface / Bone Surface (Cn.OS/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.OS/BS is measured from the bone biopsy. This measure demonstrates the percentage of the cancellous bone surface that contains unmineralized bone (osteoid). The region of interest is the predefined area of total bone that is being measured. The changes in Cn.OS/BS between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818280|NCT00395538|Secondary|Change in Cancellous Bone Mineral Apposition Rate (Cn.MAR)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.MAR is measured from the bone biopsy. This measures the rate mineral is being laid down per day in a predefined region of the cancellous bone. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes. The changes in Cn.MAR between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818281|NCT00395538|Secondary|Change in Cancellous Osteoid Thickness (Cn.O.Th)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.O.Th measured from the bone biopsy. This measures the thickness of the unmineralized bone (osteoid) in a predefined region of cancellous bone. The changes in Cn.O.Th between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um||Standard Error|Least Squares Mean
2818282|NCT00395538|Secondary|Change in Total Area of Cortical Porosity (Ct.Po.Ar)|Following their baseline bone biopsy, 5, 5, and 2 participants were randomized to receive their second bone biopsy at years 1, 2, and 4 after the start of HPTH therapy, respectively. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced in size due to withdrawal and the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ct.Po.Ar is measured from the bone biopsy. This measure defines the area of the cortical bone with holes within a predefined section of cortical bone. The changes in Tb.Sp between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants who completed both their baseline and randomized 1, 2, or 4 year bone biopsies. This will only include participants from cohorts 2 and 3.|||percentage of region of interest||Standard Error|Least Squares Mean
2818283|NCT00395538|Secondary|Total Area of Inner and Outer Cortices (Ct.Ar)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ct.AR is measured from the bone biopsy. This measure defines the area of the outer cortex and inner cortex within a predefined section of cortical bone. The changes in Ct.Ar between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of region of interest||Standard Error|Least Squares Mean
2818284|NCT00395538|Secondary|Change in Average Thickness of Inner and Outer Cortices (Ct.Th)|Participants (Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ct.Th, measured from the bone biopsy, is the average thickness of the inner and outer cortices. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes. The changes in Ct.Th between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818285|NCT00395538|Secondary|Change in Trabecular Separation (Tb.Sp)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Tb.Sp is measured from the bone biopsy. Tb.Sp is the mean distance between trabeculae, assessed using direct 3D methods. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes. The changes in Tb.Sp between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818286|NCT00395538|Secondary|Change in Trabecular Number (Tb.N)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Tb.N is measured from the bone biopsy. Tb.N is the measure of the average number of trabeculae per unit length. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes. The changes in Tb.N between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818287|NCT00395538|Secondary|Change in Trabecular Thickness (Tb.Th)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Tb.Th is measured from the bone biopsy. Tb.Th is the mean thickness of trabeculae, assessed using direct 3D methods. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes. The changes in Tb.Th between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818288|NCT00395538|Primary|Change in Intracortical Mineralizing Surface (Bone Surface Based) (Ic.MS/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.MS/BS is measured from the bone biopsy. This measure demonstrates the percentage of the intracortical bone surface that is actively forming bone. The region of interest is the predefined area of total bone that is being measured. The changes in Ic.MS/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of regional interest||Standard Error|Least Squares Mean
2818289|NCT00395538|Primary|Change in Intracortical Bone Formation Rate Per Unit of Bone Surface (Ic.BFR/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. However, because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ic.BFR/BS is measured from the bone biopsy. This measures the rate of new bone formation between the two cortical surfaces (intracortical) in a predefined region of cortical bone. The changes in Ic.BFR/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um^2/um/d||Standard Error|Least Squares Mean
2818312|NCT00395512|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2818331|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818290|NCT00395538|Primary|Change in Endocortical Mineralizing Surface (Bone Surface Based) (Ec.MS/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ec.MS/BS is measured from the bone biopsy. This measure demonstrates the percentage of the endocortical bone surface that is actively forming bone. The region of interest is the predefined area of total bone that is being measured. The changes in Ec.MS/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants who completed both their baseline and randomized 1, 2, or 4 year bone biopsies. This will only include participants from cohorts 2 and 3.|||percentage of regional interest||Standard Error|Least Squares Mean
2818291|NCT00395538|Primary|Change in Endocortical Bone Formation Rate Per Unit of Bone Surface (Ec.BFR/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. However, because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ec.BFR/BS is measured from the bone biopsy. This measures the rate of new bone formation per day on the inner cortical (endocortical) surface in a predefined region of cortical bone. The changes in Ec.BFR/BS between two time-points are being reported. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||um^2/um/d||Standard Error|Least Squares Mean
2818292|NCT00395538|Primary|Change in Cancellous Mineralizing Surface (Bone Surface Based)(Cn.MS/BS)|Following their baseline bone biopsy, 5, 5, and 2 participants were randomized to receive their second bone biopsy at years 1, 2, and 4 after the start of HPTH therapy, respectively. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced in size due to withdrawal and the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.MS/BS is measured from the bone biopsy. This measure demonstrates the percentage of the cancellous bone surface that is actively forming bone. The region of interest is the predefined area of total bone that is being measured. The changes in Cn.MS/BS between two time-points are being reported.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||percentage of predefined area of bone||Standard Error|Least Squares Mean
2818293|NCT00395538|Primary|Change in Cancellous Bone Formation Rate Per Unit of Bone Surface (Cn.BFR/BS)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.BFR/BS, measured from the bone biopsy, is the cancellous bone formation rate per unit of bone surface where cancellous refers to the spongy structure of the bone. The changes in Cn.BFR/BS between two time-points are being reported. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818294|NCT00395538|Primary|Change in Total Number of Cortical Pores Per mm^2 (Ct.Po.N)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, so the 2-, and 4-year biopsies were collapsed into one biopsy year group. Ct.Po.N is a bone biopsy measure that assess the amount of holes in the cortical bone within a predetermined area of cortical bone. The changes in Cn.BV/TV outcome between two time-points are being reported. Cortical bone with a higher number of holes may be at greater risk of fracture. The n's in the outcome measure table refer to the number of complete records (non-missing baseline and post-baseline measures).|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||cortical pores/mm^2||Standard Error|Least Squares Mean
2818313|NCT00395512|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
2818328|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818295|NCT00395538|Primary|Change in Bone Biopsy Cancellous Bone Volume (Cn.BV/TV)|Participants (in Cohorts 2 and 3) were randomized to receive their second bone biopsy at year 1, 2, or 4 after the start of HPTH therapy. For Cohort 2, the baseline bone biopsy was completed at the start of CC on the original protocol. For Cohort 3, the baseline biopsy was completed immediately prior to the first HPTH dose. Because the sample sizes for the 1-, 2- and 4-year biopsies are reduced due to the early termination of the study, so the 2-, and 4-year biopsies were collapsed into one biopsy year group. Cn.BV/TV is one of 8 primary endpoints measured from the bone biopsy. The changes in Cn.BV/TV outcome between two time-points are being reported. The unit of measure is a z-score. Z-scores are normed to standard populations to a mean of zero and a standard deviation of 1. The normal range for a z-score is from -2 to 2. Values above or below this normal range are considered worse outcomes.|Baseline, 1 year bone biopsy, and combined 2 and 4 year bone biopsies|The Bone Biopsy Analysis Population was used for the primary bone biopsy biomarkers. The Bone Biopsy Population consisted of all participants in Cohorts 2 and 3 who completed both their baseline and randomized 1, 2, or 4 year bone biopsies.|||z-score||Standard Error|Least Squares Mean
2818296|NCT00395512|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
2818297|NCT00395512|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||µmol/L||Standard Error|Least Squares Mean
2818298|NCT00395512|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
2818299|NCT00395512|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2818300|NCT00395512|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|"The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2818301|NCT00395512|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nm||Standard Error|Least Squares Mean
2818302|NCT00395512|Secondary|Change From Baseline in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2818303|NCT00395512|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818304|NCT00395512|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2818305|NCT00395512|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2820205|NCT00382863|Secondary|Participants Experiencing Serious Adverse Events|Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.|||participants|||Number
2818316|NCT00395512|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818317|NCT00395512|Secondary|Change From Baseline in Total Cholesterol Level|Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818318|NCT00395512|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.|Baseline and Weeks 8, 12, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||kg||Standard Error|Least Squares Mean
2818319|NCT00395512|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
2818320|NCT00395512|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
2818321|NCT00395512|Secondary|Change From Baseline in C-peptide Levels|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2818322|NCT00395512|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2818323|NCT00395512|Secondary|Change From Baseline in Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||μIU/mL||Standard Error|Least Squares Mean
2818324|NCT00395512|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2818325|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818326|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818327|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818329|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2818332|NCT00395512|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:~After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L);~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L);~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c."|Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with visits during or after the specified interval in each treatment group.|||percentage of participants|||Number
2818333|NCT00395512|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.|Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with at least one non-missing fasting plasma glucose result in the specified interval in each treatment group.|||percentage of participants|||Number
2818334|NCT00395512|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2818335|NCT00395512|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|Baseline and Weeks 4, 8, 12, 16 and 20.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2818336|NCT00395512|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|The Full analysis Set (all randomized patients who took at least 1 dose of double-blind study drug) where a Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2818337|NCT00395486|Secondary|Percentage Change of Apolipoprotein B (ApoB)|Calculate the percentage change of apolipoprotein B|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818338|NCT00395486|Secondary|Percentage Change of Apolipoprotein A1 (ApoA1)|Calculate the percentage change of Apolipoprotein A1|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818339|NCT00395486|Secondary|Percentage Change of Triglycerides (TG)|Calculate the percentage change of Triglycerides.|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818340|NCT00395486|Secondary|Percentage Change of High-Density Lipoprotein-C (HDL-C)|Calculate the percentage change of HDL-C level|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818341|NCT00395486|Secondary|Percentage Change of Total Cholesterol (TC)|Calculate the percentage change of total cholesterol level|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818342|NCT00395486|Secondary|Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)|Calculate the percentage reduction of LDL-C|Baseline and 6 weeks||||percentage reduction||Standard Deviation|Mean
2818343|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using QUICKI|QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818344|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using HOMA-R|HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5|Baseline and 6 weeks||||percentage change||Standard Deviation|Mean
2818345|NCT00395486|Secondary|Percentage Change of Glucose Level|Using laboratory test, mean change of glucose level was investigated.|Baseline and 6 weeks||||Percentage change||Standard Deviation|Mean
2818346|NCT00395486|Secondary|Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.|Baseline and 6 weeks||||percentage of participants|||Number
2818347|NCT00395486|Secondary|Percentage of Subjects Reaching Their LDL-C Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).|Baseline and 6 weeks||||percentage of participants|||Number
2818348|NCT00395486|Primary|Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6|Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.|Baseline and 6 weeks||||percent change||Standard Deviation|Mean
2818349|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with CNS lesions other than primary malignant brain tumor(s) / brain metastases|||Lesions||Standard Deviation|Mean
2818373|NCT00395304|Secondary|Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
2818350|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with primary malignant brain tumor(s) / brain metastases|||Lesions||Standard Deviation|Mean
2818351|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with CNS lesions other than primary malignant brain tumor(s) / brain metastases. 1 (Gadavist) and 2 participants (Magnevist) had missing values for signal intensity for CNS lesions pre- and post-contrast and could not be considered for evaluation.|||Contrast to Noise ratio||Standard Deviation|Mean
2818352|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with primary malignant brain tumor(s) / brain metastases. One participant in the Gadavist group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.|||Contrast to Noise ratio||Standard Deviation|Mean
2818353|NCT00395460|Secondary|Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions|Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.|||Lesion delineation score||Standard Deviation|Mean
2818354|NCT00395460|Secondary|Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI|The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.|||Contrast enhancement score||Standard Deviation|Mean
2818355|NCT00395460|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment|"The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as improved, unchanged or worsened for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4)."|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases.|||Participants|||Number
2818356|NCT00395460|Secondary|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan|The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases|||Lesions||Standard Deviation|Mean
2818357|NCT00395460|Primary|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions|CNR = (signal intensity [SI] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Two participants in each treatment group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.|||Contrast to Noise ratio||Standard Deviation|Mean
2818372|NCT00395304|Secondary|Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability|PEFR variability is calculated as 100% times the difference between the evening and morning PEFR values, divided by the average of the evening and morning PEFR values, i.e., PEFR variability = 100% x (morning PEFR - evening PEFR)/((morning PEFR + evening PEFR)/2)|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
2818358|NCT00395447|Primary|Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)|The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).|6 months||||Percentage of participants (%)||95% Confidence Interval|Mean
2818359|NCT00395343|Other Pre-specified|Change From Baseline in A1C at Week 24|"A1C in subset of patients on long-acting or intermediate-acting insulin.~A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included the subset of patients on long-acting or intermediate-acting insulin with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2818360|NCT00395343|Secondary|Percent of Patients With A1C < 6.5% at Week 24||Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent|||Number
2818361|NCT00395343|Secondary|Percent of Patients With A1C < 7.0% at Week 24||24 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent|||Number
2818362|NCT00395343|Secondary|Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24|Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.)|Baseline and Week 24|The Full Analysis Set (FAS) included all patients who participated in the 10-point meal tolerance test and had a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2818363|NCT00395343|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2818364|NCT00395343|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2818365|NCT00395343|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2818366|NCT00395304|Secondary|Number of Participants With Asthma Exacerbations|An asthma exacerbation was defined as the administration of a course of oral/systemic prednisone for the treatment of asthma.|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||Participants|||Count of Participants
2818367|NCT00395304|Secondary|Change From Baseline in Asthma Quality of Life|Asthma quality of life is measured as the average of 23 questions, each of which is scored from 1 (worse) to 7 (best)|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||units on a scale||Standard Deviation|Mean
2818368|NCT00395304|Secondary|Change From Baseline in the Asthma Control Test (ACT)|The ACT consists of five items, each scored as 1 (worst) to 5 (best). The five items are averaged.|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||units on a scale||Standard Deviation|Mean
2818369|NCT00395304|Secondary|Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||natural logarithm of parts per billion||Standard Deviation|Mean
2818370|NCT00395304|Secondary|Change From Baseline in the Logarithm Base 2 of the Methacholine PC20|The methacholine PC20 is the concentration of methacholine that causes a 20% decrease in the pre-bronchodilator FEV1. The logarithm base 2 transformation converts the PC20 into doubling dilutions.|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||doubling dilutions||Standard Deviation|Mean
2818371|NCT00395304|Secondary|Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz|Change from baseline in the impulse oscillometry resistance at 5 Hertz, measured in kiloPascals per liters per second|Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||kiloPascals per liters per second||Standard Deviation|Mean
2818374|NCT00395304|Secondary|Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
2818375|NCT00395304|Secondary|Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||ratio||Standard Deviation|Mean
2818376|NCT00395304|Secondary|Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
2818377|NCT00395304|Secondary|Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
2818378|NCT00395304|Secondary|Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted||Measured during the last 12 weeks of each 16-week treatment period|Patients who completed the 16-week treatment period for the specific treatment (2xICS, 1xICS + LABA, or 1xICS + LTRA) within the three-way crossover design|||percentage points||Standard Deviation|Mean
2818379|NCT00395304|Primary|The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.|One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.|Measured during the last 12 weeks of each 16-week treatment period|ITT. Although only 157 participants completed all three treatment periods, there was sufficient data on 8 additional participants to include them in the analysis of the primary outcome.|||Participants|||Number
2818380|NCT00395291|Secondary|Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and lab results were available for all 22.|||pg/ml||Standard Deviation|Mean
2818381|NCT00395291|Secondary|Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||ng/ml||Standard Deviation|Mean
2818382|NCT00395291|Secondary|Change in Esterase After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and results were available.|||units/ml||Standard Deviation|Mean
2818383|NCT00395291|Secondary|Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/ml||Standard Deviation|Mean
2818384|NCT00395291|Secondary|Changes in the Following Level: IL-6|Change in IL-6 after 30 days of intervention.|After the subject has comleted their last visit|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/mL||Standard Deviation|Mean
2818385|NCT00395291|Secondary|Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/ml||Standard Deviation|Mean
2818386|NCT00395291|Secondary|Change in CRPs After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.|||mg/ml||Standard Deviation|Mean
2818387|NCT00395291|Secondary|Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.|||pg/ml||Standard Deviation|Mean
2818388|NCT00395291|Secondary|Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.|||pg/ml||Standard Deviation|Mean
2818389|NCT00395291|Secondary|Change in Insulin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.|||uIU/ml||Standard Deviation|Mean
2818390|NCT00395291|Secondary|Change in Leptin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.|||ng/ml||Standard Deviation|Mean
2820206|NCT00382863|Secondary|All-Cause Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations|12 months|Population is intent to treat.|||participants|||Number
2818391|NCT00395291|Secondary|Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention.|22 subjects completed both interventions.|||pg/ml||Standard Deviation|Mean
2818392|NCT00395291|Primary|Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions and lab results were available.|||ng/ml||Standard Deviation|Mean
2818393|NCT00395226|Primary|Severity of Facial Rosacea After 90 Days of Treatment|Modified Rosacea Severity Scoring System evaluating four signs of rosacea, flushing (transient erythema or redness), erythema (redness), papules and pustules and telangiectasia (spider-veins) ranges from 0 (best, absent) to 12 (worst, severe on all items)|90 days||||units on scale 0 to 12||95% Confidence Interval|Mean
2818394|NCT00395161|Secondary|All-cause 28-day Mortality Rate.||28 days after admission to the PICU|This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status.|||participants|||Number
2818395|NCT00395161|Secondary|Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)|What is reported is the number of participants with counts qualifying as lymphopenia.|from time of PICU admission till discharge from PICU|All randomized patients (intention to treat analysis)|||participants|||Number
2818396|NCT00395161|Secondary|Antibiotic-free Days||48 hours after admission until PICU discharge|All randomized patients per intention to treat analysis|||Days||Inter-Quartile Range|Median
2818397|NCT00395161|Secondary|Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days||48 hours after PICU admission till discharge from PICU|All randomized patients analyzed by intention to treat|||Mean number of events per 100 study days||95% Confidence Interval|Mean
2818398|NCT00395161|Primary|The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.||48 hours after admission until 5 days after discharged from the PICU|Intention to treat analysis of all randomized patients.|||Days||95% Confidence Interval|Median
2818399|NCT00395135|Secondary|Year 2: Percent Change in Body Weight From Week 52 to Week 104|Year 2: The % change in body weight (kg) from week 52 to week 104.|52 weeks|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
2818400|NCT00395135|Secondary|Year 1: Percent Change in Body Weight From Baseline to Week 52|Year 1: The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF|||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
2818401|NCT00395135|Primary|Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104|The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.|104 weeks|MITT with LOCF|||percentage of participants|||Number
2818402|NCT00395135|Primary|Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF|||percentage of participants|||Number
2818403|NCT00395083|Secondary|Time to All-Cause Death||From randomization until death, assessed up to 26 months||||years||95% Confidence Interval|Median
2818404|NCT00395083|Secondary|Hazard Ratio for All-Cause Mortality||26 months||||participants|||Number
2818405|NCT00395083|Primary|Hazard Ratio for First COPD Hospitalization||26 months||||participants|||Number
2818406|NCT00395083|Primary|Hospitalization-free Survival - Time to Event||From randomization until date of first hospitalization for COPD, assessed up to 26 months||||years||95% Confidence Interval|Median
2818407|NCT00395057|Secondary|Time to Treatment With Standard of Care at Month 6|Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.|Month 6|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).|||Number of Days||95% Confidence Interval|Median
2818408|NCT00395057|Secondary|Visual Functioning Questionnaire (VFQ) at Month 3|Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early.||||||
2818409|NCT00395057|Secondary|Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3|Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).|||Microns||Standard Deviation|Mean
2818410|NCT00395057|Secondary|Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3|Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.|Month 3|Intent-To-Treat. The ITT population included all patients who started the study (randomized).|||Millimeters squared (mm^2)||Standard Deviation|Mean
2818451|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 13|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 13|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818411|NCT00395057|Primary|Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3|Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).|||Percentage of Patients|||Number
2818412|NCT00395044|Secondary|Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4|The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning.|Week 0 and Week 4|Cognitive testing was done in a subset of participants enrolled in the study, beginning with randomized subject #21 and continuing until the 50th subject was randomized. The number analyzed is the total number available for analysis that completed both the Baseline and Week 4 assessment.|||scores on a scale||Standard Deviation|Mean
2818413|NCT00395044|Secondary|Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12|The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
2818414|NCT00395044|Secondary|Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12|The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
2818415|NCT00395044|Secondary|Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12|The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
2818416|NCT00395044|Secondary|Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12|The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
2818417|NCT00395044|Secondary|Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12|The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12||||units on a scale||Standard Deviation|Mean
2818418|NCT00395044|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use.|Week 0 and Week 12||||ng/ml||Standard Deviation|Mean
2818419|NCT00395018|Primary|Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At baseline (day 1), week 12, 24, 36, 48, 60, and 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Non-Completer = Missing (NC = M) approach was used where participants who discontinued early or were missing the measurement were excluded from the specific analysis.|||participants||95% Confidence Interval|Number
2818420|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)|Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value<LLN (lower limit of normal).|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.|||participants|||Number
2818421|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)|Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: All subjects who received atleast 1 dose of study drug.|||participants|||Number
2818452|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 12|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 12|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818453|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 11|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 11|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818422|NCT00395018|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.|||participants|||Number
2818423|NCT00395018|Secondary|Number of Participants With Re-transplantation Through Week 72||Through week 72|Treated population: Participants who received atleast 1 dose of study drug.|||participants|||Number
2818424|NCT00395018|Secondary|Number of Participants With Liver Rejection Through Week 72||Through week 72|Treated participants: Participants who received atleast 1 dose of study drug.|||participants|||Number
2818425|NCT00395018|Secondary|Prothrombin Time (PT) at Week 72|Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN.|At week 72|Treated participants with measures available at week 72.|||seconds||Standard Error|Mean
2818426|NCT00395018|Secondary|Total Bilirubin at Week 72|Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL.|At week 72|Treated participants with measures available at week 72.|||mg/dL||Standard Error|Mean
2818427|NCT00395018|Secondary|Percentage of Participants With HBsAg Recurrence At Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
2818428|NCT00395018|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
2818429|NCT00395018|Secondary|Percentage of Participants With HBsAg Loss at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
2818430|NCT00395018|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|At week 72|HBeAg-positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
2818431|NCT00395018|Secondary|Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.|At week 72|HBeAg positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
2818432|NCT00395018|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up|HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL.|At 72 weeks + 24 weeks follow-up|This analysis was planned if > 10% of treated participants had HBV DNA measurements during the off-treatment follow-up period.|||percentage of participants|||Number
2818433|NCT00395018|Secondary|Distribution of ALT Levels Through 72 Weeks: Overall|ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal).|On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy.|||U/L||Standard Error|Mean
2818434|NCT00395018|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At 72 weeks|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Last observation carried forward (LOCF) approach was used for participants with no measurement in the specified visit window.|||percentage of participants||95% Confidence Interval|Number
2818454|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 10|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 10|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818455|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 9|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 9|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818435|NCT00394953|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.|From screening to Week 56|The Safety Population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Among the 14 deaths in Darbepoetin alfa group, 3 participants died after withdrawal from the study and within 30 days after last dose of study drug.|||Participants|||Number
2818436|NCT00394953|Secondary|Mean Pulse Rate Over Time|Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|The Safety population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.|||beats per minute||Standard Deviation|Mean
2818437|NCT00394953|Secondary|Median Blood Pressure Over Time|Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|Safety Population included all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.|||millimeter of mercury||Full Range|Median
2818438|NCT00394953|Secondary|Number of Participants With Marked Laboratory Abnormality Over Time|Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.|||participants|||Number
2818439|NCT00394953|Secondary|Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time|All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.|Week 27 to Month 12|ITT population included all randomized participants. Data is presented for the participants available at the time of assessment.|||percent change||Standard Deviation|Mean
2818440|NCT00394953|Primary|Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period|Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.|Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)|ITT population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2818441|NCT00394914|Secondary|LS Mean Change From Baseline in Asthma-Related Sleep Interference|Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some sleep follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
2818442|NCT00394914|Secondary|LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage|SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some SABA follow-up information.|||number of puffs of SABA||Standard Deviation|Least Squares Mean
2818456|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 8|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 8|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818443|NCT00394914|Secondary|LS Mean Change From Baseline in Total Asthma Symptom Score|Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some asthma symptom score follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
2818444|NCT00394914|Secondary|LS Mean Change From Baseline in Total Cold Symptom Score|Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some cold symptom score follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
2818445|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.|||L/min||Standard Deviation|Least Squares Mean
2818446|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.|||L/min||Standard Deviation|Least Squares Mean
2818447|NCT00394914|Secondary|LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some FEV1 follow-up information.|||liters||Standard Deviation|Least Squares Mean
2818448|NCT00394914|Secondary|LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)|The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some ACQ follow-up information.|||units on a scale||Standard Deviation|Least Squares Mean
2818449|NCT00394914|Primary|Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR|"Asthma exacerbation was defined as a participant having one of the following:~0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ.~Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization.~PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization."|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine exacerbation.|||percentage of participants|||Number
2818450|NCT00394914|Primary|Percentage of Participants With Rhinovirus PCR-Positive Colds|The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine rhinovirus cold.|||percentage of participants|||Number
2818478|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818457|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 7|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 7|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818458|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 6|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 6|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818459|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 5|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 5|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818460|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 4|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 4|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818461|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 3|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 3|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818462|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 2|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 2|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818463|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 1|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 1|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818464|NCT00394901|Primary|Mean Pain Scores at Week 13|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 13|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818465|NCT00394901|Primary|Mean Pain Scores at Week 12|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 12|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818466|NCT00394901|Primary|Mean Pain Scores at Week 11|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 11|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818467|NCT00394901|Primary|Mean Pain Scores at Week 10|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 10|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818468|NCT00394901|Primary|Mean Pain Scores at Week 9|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 9|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818469|NCT00394901|Primary|Mean Pain Scores at Week 8|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 8|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818470|NCT00394901|Primary|Mean Pain Scores at Week 7|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 7|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818471|NCT00394901|Primary|Mean Pain Scores at Week 6|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 6|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818472|NCT00394901|Primary|Mean Pain Scores at Week 5|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 5|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818473|NCT00394901|Primary|Mean Pain Scores at Week 4|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week4|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818474|NCT00394901|Secondary|Number of Patients Not Reporting Hyperalgesia|Participants not reporting hyperalgesia.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
2818475|NCT00394901|Secondary|Number of Patients Not Reporting Allodynia|Participants not reporting allodynia.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
2818476|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Mental Health|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818477|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Vitality|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2829998|NCT00301873|Secondary|Skeletal-related Complications|Number of patients who experience skeletal-related complications during the administration of Zoledronate.|1 year|All patients.|||participants|||Number
2818480|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818481|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818482|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818483|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818484|NCT00394901|Secondary|Endpoint Clinical Global Impression Change|Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
2818485|NCT00394901|Secondary|Endpoint Patient Global Impression Change|Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Deviation|Mean
2818486|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep|Number of participants who reported Optimal Sleep|Week13/discontinuation|Full analysis set. Last observation carried forward.|||participants|||Number
2818487|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index|Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818488|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence|Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818489|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy|Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818490|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep|Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818491|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache|Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818492|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring|Score range for snoring is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818493|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance|Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818494|NCT00394901|Secondary|Mean Sleep Interference Scores at Endpoint|Scores range from 0-10. Higher scores indicate more severe interference with sleep.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818495|NCT00394901|Secondary|Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire|Present pain intensity score range from 0-5. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818496|NCT00394901|Secondary|Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire|Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||mm||Standard Error|Least Squares Mean
2818497|NCT00394901|Secondary|Endpoint Total Scores of the Short-Form McGill Pain Questionnaire|Total score range from 0-45. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward|||score on scale||Standard Error|Least Squares Mean
2818498|NCT00394901|Secondary|Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire|Affective score range from 0-12. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818499|NCT00394901|Secondary|Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire|Sensory score range from 0-33. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818500|NCT00394901|Primary|Mean Pain Scores at Week 3|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 3|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818501|NCT00394901|Primary|Mean Pain Scores at Week 2|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 2|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818502|NCT00394901|Primary|Mean Pain Scores at Week 1|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 1|Full analysis set. Observed case.|||score on scale||Standard Error|Least Squares Mean
2818504|NCT00394901|Primary|Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818505|NCT00394901|Primary|Mean Pain Scores at Endpoint|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.|||score on scale||Standard Error|Least Squares Mean
2818506|NCT00394888|Primary|Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound|The number of participants with multiple (greater than or equal to 5) cutaneous infantile hemangiomas who were found to have hepatic hemangiomas via the us abdominal ultrasound.|2 years|Subjects enrolled in the hepatic hemangioma arm (n= 151) were analyzed for this outcome measure.|||Participants|||Number
2818507|NCT00394888|Primary|Cardiac Abnormalities Detected Via Clinical Examination|The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.|||Participants|||Number
2818508|NCT00394888|Primary|Cerebrovascular and Structural Brain Abnormalities|The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.|||Participants|||Number
2818509|NCT00394888|Primary|Spinal Abnormalities|The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.|2 years|Subjects enrolled in the lumbrosacral hemangioma arm (n= 48) were analyzed for this outcome measure|||Participants|||Number
2818510|NCT00394888|Primary|Clinical Diagnosis of PHACE Syndrome|For subjects in the large facial hemangioma arm of the study, a clinical assessment by trained physicians was conducted to determine whether or not each subject met diagnostic criteria for PHACE syndrome.|2 years|Subjects enrolled in the large facial hemangioma arm (n= 108) were analyzed for this outcome measure.|||Participants|||Number
2818511|NCT00394888|Primary|MRI/MRA of Head/Neck/Chest.||2 years||||participants|||Number
2818512|NCT00394836|Secondary|Vss After the Eighth Infusion (Visit 9, Week 7)|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; to up 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data of 28 April 2009.|||mL||Geometric Coefficient of Variation|Geometric Mean
2818513|NCT00394836|Secondary|CL After the Eighth Infusion (Visit 9, Week 7)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2818514|NCT00394836|Secondary|t1/2 After the Eighth Infusion (Visit 9, Week 7)|t1/2 is defined as terminal half-life, which is the time required for the amount of the drug in the body to decrease by half.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||hours||Geometric Coefficient of Variation|Geometric Mean
2818515|NCT00394836|Secondary|AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
2818516|NCT00394836|Secondary|Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before the start of the next infusion]).|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants who had a value. Cmax was not reported for one participant due to missing data. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.|||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2818517|NCT00394836|Secondary|Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.)|FcR poly. affect the affinity with which FcRs interact with immunoglobulin molecules and are prognostic factors that are indicative of altered responsiveness to treatment and/or survival. A blood sample was drawn at Visit 1 for analysis (done in batches of several samples) of FcR poly. (Fcgamma RIIIa Valine/Phenylalanine genotypes [TT=thymidine/thymidine, TG=thymidine/guanine, GG=guanine/guanine] and Fcgamma RIIa Arginine/Histidine genotypes [AA=adenine/adenine, AG=adenine/guanine, GG=guanine/guanine]). Responders must have met the criteria for CR, CRu, or PR at either Month 3 or Month 6. Fc receptor polymorphisms and C1qA-276 results are not included in this results summary.|From first treatment (Visit 2) until Visit 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||participants|||Number
2818518|NCT00394836|Secondary|Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2|Blood samples were drawn from participants at Visits 1 and 2 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 2 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2) and 2 (Week 0)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Units per milliliter (U/mL)||Full Range|Median
2818519|NCT00394836|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were withdrawn from participants at Visits 1, 12, 13, and 18 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||participants|||Number
2818520|NCT00394836|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) until Visit 18 (Month 24)|FAS|||participants|||Number
2818521|NCT00394836|Secondary|Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood|"B-cell lymphoma 2 (BCL2) is the second member of a range of proteins initially described in chromosomal translocations involving chromosomes 14 and 18 in follicular lymphomas. BCL2 mitochondrial ribonucleic acid (mRNA) was measured by polymerase chain reaction (PCR) from peripheral blood. Participants who had no post-screening data were categorized as Missing."|Screening (Visit 1) until Month 24 (Visit 18)|FAS. Only those participants who were BCL2 positive at Screening were analyzed.|||participants|||Number
2818522|NCT00394836|Secondary|Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12|CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+. The analysis will be done until a value is reached that is in the normal range. Percent change from Baseline (Visit 2) = (value at Visits 11 and 12 minus the value at Visit 2 divided by the value at Visit 2) * 100.|Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in cells||95% Confidence Interval|Median
2818523|NCT00394836|Secondary|Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24|Tumor size was measured by computed tomography (CT) scan and was computed as the sum of product of diameters (SPD) for the indicator lesions. CT scans with contrast of the neck, thorax, abdomen, and pelvis were performed at Screening and during the follow-up period (Month 3, 6, 9, 12, 18, and 24). The change in tumor size from Screening (Visit 1) was presented per Radiologist 1 (R1) and Radiologist 2 (R2). Percent change from Screening (Visit 1, Week -2) = (value at Visits 11, 12, 13, 14, 16, and 18 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||percent change in tumor size||Full Range|Median
2818524|NCT00394836|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. For participants who are lost to follow-up, overall survival will be censored at the date of the last attended visit at which the endpoint was assessed.|First dose (Week 0) until 5 years|FAS. As of the time of data cut-off, data for Overall Survival was not estimable because too few deaths have occurred at the time of study completion.|||Months||95% Confidence Interval|Median
2818525|NCT00394836|Secondary|Time to Next Follicular Lymphoma (FL) Therapy|Time to next FL (anti-lymphoma) therapy is defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From start of treatment (Week 0) until Month 24|FAS|||Months||95% Confidence Interval|Median
2818526|NCT00394836|Secondary|Progression-Free Survival|Progression-free survival (PFS) is defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From start of treatment (Week 0) until Month 24|FAS|||Months||95% Confidence Interval|Median
2818527|NCT00394836|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate duration of response.|From start of treatment (Week 0) until Month 24|FAS. Only those participants classified as responders were analyzed.|||months||95% Confidence Interval|Median
2818528|NCT00394836|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response (OR)|Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node >1 cm), or Not Evaluable (NE) participants were classified as non-responders.|6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).|FAS|||participants|||Number
2818529|NCT00394836|Primary|Number of Participants With Objective Response (OR)|OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass >1.5 centimeters [cm] in its longest transverse diameter that regressed >75% compared to baseline), or Partial Response (PR; >=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment|||participants|||Number
2818530|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||days||Full Range|Median
2818531|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||days||Full Range|Median
2818532|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||participants|||Number
2818533|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||participants|||Number
2818534|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||participants|||Number
2818535|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||participants|||Number
2818536|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||participants|||Number
2818537|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||participants|||Number
2818538|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||days||Full Range|Median
2818539|NCT00394771|Secondary|Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)|"Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.~Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.~See pre-specified analyses for Number of Moderate to Heavy Bleeding Days."|Day 1-84|ITT population. However data was not summarized due to limitations in the diary data.||||||
2818540|NCT00394771|Secondary|Time to First Bleeding Day|"Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.~Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding."|Day 1-84|ITT population. However this data was not summarized due to limitations in the diary data.||||||
2818541|NCT00394771|Secondary|Days With Bleeding During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.|||days||Full Range|Median
2818542|NCT00394771|Secondary|Days With Bleeding During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||days||Full Range|Median
2818543|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.|||days||Full Range|Median
2818544|NCT00394706|Secondary|Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months|The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).|6 months post hospital discharge|ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.|||units on a scale||Standard Deviation|Mean
2818545|NCT00394706|Secondary|Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months|The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse.|6 months post hospital discharge|ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.|||units on a scale||Standard Deviation|Mean
2818546|NCT00394706|Secondary|Modified Rankin Score at 6 Months After Hospital Discharge|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).|6 months post hospital discharge|ITT population, survived to hospital discharge, consented to participate in the post-discharge substudy, and with at least one post-discharge assessment.|||units on a scale||Standard Deviation|Mean
2818547|NCT00394706|Secondary|Survival to Hospital Discharge||Survival to hospital discharge or death before discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.|||participants|||Number
2818548|NCT00394706|Primary|Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.|Hospital discharge or death prior to discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.|||participants|||Number
2818549|NCT00394654|Secondary|Terminal Phase Volume of Distribution (Vz)|Vz of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Liter||Geometric Coefficient of Variation|Geometric Mean
2818550|NCT00394654|Secondary|Total Body Clearance (CL)|CL of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Liter per day||Geometric Coefficient of Variation|Geometric Mean
2818551|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained|||Day||Geometric Coefficient of Variation|Geometric Mean
2818552|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained|||Day||Geometric Coefficient of Variation|Geometric Mean
2818553|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
2818554|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained|||Percent||Geometric Coefficient of Variation|Geometric Mean
2818555|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained|||Percent||Geometric Coefficient of Variation|Geometric Mean
2818556|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Percent||Geometric Coefficient of Variation|Geometric Mean
2818557|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818558|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818559|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818560|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818561|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528|||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818562|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818563|NCT00394654|Secondary|Observed Maximum Nasal Lavage Concentration (Cmax)|Cmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818564|NCT00394654|Secondary|Observed Maximum Sputum Concentration (Cmax)|Cmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818565|NCT00394654|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2818566|NCT00394654|Secondary|Time to Observed Maximum Nasal Lavage Concentration (Tmax)|Tmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528|||Day||Geometric Coefficient of Variation|Geometric Mean
2818572|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
2818573|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
2818574|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
2818575|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
2818576|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
2818577|NCT00394654|Primary|Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.|||Percent||Standard Deviation|Mean
2818578|NCT00394589|Primary|Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.|Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).|Between Screening (Week <=1) and Week 24|Intent-to-treat population; subjects with available data at both Baseline and Week 24|||Score on a Scale||Standard Deviation|Mean
2818579|NCT00394524|Secondary|Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion|mean number of days the patients stayed in the hospital are measured among the Glucommander group and standard insulin infusion and compared|During the complete length of hospitalization, up to 60 days||||days||Standard Deviation|Mean
2818580|NCT00394524|Secondary|Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group|Mean number of days, the patients stayed in the intensive care unit are measured among glucommander group and standard insulin infusion group.|During ICU hospitalization, up to 30 days||||days||Standard Deviation|Mean
2818581|NCT00394524|Secondary|Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm|Severe hypoglycemia is defined as the blood glucose (BG) levels lower than 40 mg/dL. The number of patients enrolled among both groups with the reports of having the BG levels lower than 40 mg/dL are recorded for duration of 10 days|First 10 days of ICU stay||||Participants|||Count of Participants
2818582|NCT00394524|Primary|Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion|Daily mean blood glucose concentrations during insulin infusion with the Glucommander and a standard paper form insulin infusion algorithm are measured every day up until 10 days and a mean values of these levels are calculated. The Mean blood glucose concentrations are measured once the target blood glucose levels are achieved after admission|First 10 days of ICU stay||||mg/dl||Standard Deviation|Mean
2818583|NCT00394472|Secondary|Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule||An interval of one to two hours after the first intake of AZD3355 65 mg capsule||||μmol/L||Standard Deviation|Mean
2818584|NCT00394472|Primary|Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment|Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary|Twice daily during the last seven days on treatment||||Participants|||Number
2818585|NCT00394433|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all enrolled patients.|||months||95% Confidence Interval|Median
2818586|NCT00394433|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.|Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).|The analysis dataset is comprised of all enrolled patients.|||months||95% Confidence Interval|Median
2818599|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!)||Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters||Standard Error|Least Squares Mean
2818587|NCT00394433|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all treated and evaluable patients.|||participants|||Number
2818588|NCT00394433|Primary|10-month Progression-Free Survival Rate|10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.|The analysis dataset is comprised of all enrolled patients.|||probability (%)||95% Confidence Interval|Number
2818589|NCT00394355|Secondary|Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).|Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward)|Baseline and up to ~ one year of treatment||||percentage of FEV1||Standard Deviation|Mean
2818590|NCT00394355|Secondary|Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants|||percentage of BMD||Standard Deviation|Mean
2818591|NCT00394355|Secondary|Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants|||percentage of BMD||Standard Deviation|Mean
2818592|NCT00394355|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants|||percentage of BMD||Standard Deviation|Mean
2818593|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Asthma Control Test (ACT)|The ACT consisted of five questions, each ranging from 1 (worst) to 5 (best). The five questions were summed to yield an overall score that ranged from 5 (worst) to 25 (best).|The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
2818594|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment|The asthma-specific quality of life scale ranged from 1 (worst) to 7 (best)|The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||units on a scale||Standard Error|Least Squares Mean
2818595|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion||eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||parts per billion||Standard Error|Least Squares Mean
2818596|NCT00394329|Secondary|Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability|PEFR variability represents the relative change between the evening and morning PEFR measurements, so it could be a positive or negative number. It was measured daily during the 44-week treatment period. Specifically, the PEFR variability on a specific day is defined as 100% x (evening PEFR - morning PEFR)/{0.5*(evening PEFR + morning PEFR)}|PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||relative change (AM and PM peak flow)||Standard Error|Least Squares Mean
2818597|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR)||Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters per minute||Standard Error|Least Squares Mean
2818598|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR)||Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||liters per minute||Standard Error|Least Squares Mean
2819135|NCT00390299|Other Pre-specified|Change in CD4 Counts|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to day 28|||||||
2818600|NCT00394329|Secondary|Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day||Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||count of the number of puffs per day||Standard Error|Least Squares Mean
2818601|NCT00394329|Secondary|Change Between Week 44 and Week 0 in the Asthma Control Days||An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis|||proportion of asthma control days||Standard Error|Least Squares Mean
2818602|NCT00394329|Primary|Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy||Measured during the 44-week treatment period|All randomized participants were included in the time-to-event analysis|||participants||95% Confidence Interval|Number
2818603|NCT00394277|Secondary|SVR-12 (Actual Treatment Period)|SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
2818604|NCT00394277|Secondary|SVR-12 (Scheduled Treatment Period)|SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
2818605|NCT00394277|Secondary|SVR-24 (Actual Treatment Period)|SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.|24 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
2818606|NCT00394277|Primary|Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)|SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).|Week 72|Intent-to-treat population (all patients treated with at least one dose of either study medication)|||Percentage of patients|||Number
2818607|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10)."|Month 10|Participants in the Treated Population for whom safety data was available 6 months post-chemotherapy|||participants|||Number
2818608|NCT00394251|Secondary|Summary of Participants' Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)|"Summary of the most severe grades using the National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests.~Grade 0 = within normal range for all measurements.~Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST):~Grade 1 = > upper limit of normal (ULN) - 2.5*ULN~Grade 2= >2.5-5.0*ULN~Grade 3= >5.0-20.0*ULN~Grade 4= >20.0*ULN~Bilirubin:~Grade 1= >ULN - 1.5*ULN~Grade 3= >3.0 - 10.0*ULN~Creatinine:~- Grade 1= >ULN - 1.5*ULN"|Week 1 up to week 50|Treated population with at least one post-treatment laboratory measure.|||participants|||Number
2818609|NCT00394251|Secondary|Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation|Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized.|up to week 46|Participants in the treated population who had both baseline and one treatment measurement for %LVEF|||percentage of healthy LVEF||Full Range|Median
2818610|NCT00394251|Secondary|Myelosuppression During Taxane Dosing Cycles|"Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).~Grade 1 = <lower limit of normal (LLN)-1.5*10^9/L~Grade 2 = <1.5 - 1.0*10^9/L~Grade 3 = <1.0 - 0.5*10^9/L~Grade 4 = <0.5*10^9/L~Values are reported across all severity grades without assessment of relationship to taxane treatment, and also by relation to taxane treatment as reported by investigators."|Weeks 9-16|Participants in the treated population who received at least 1 dose of taxane and had laboratory values.|||participants|||Number
2818611|NCT00394251|Secondary|Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays|"Counts of participants who~completed the protocol-defined treatment cycles,~had a dose interruption~had a dose reduction~had a dose delay. A dose delay refers to the delay of all interventions in the cycle.~Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.~Use of pegfilgrastim is included in the summary."|up to Week 46|Treated population|||participants|||Number
2818612|NCT00394251|Secondary|Percent of Protocol Taxane Dose|Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.|||percentage of protocol-defined taxane||Standard Deviation|Mean
2818655|NCT00393718|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
2818613|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7)."|Month 7|Participants in the Treated Population for whom safety data was available 3 months post-chemotherapy|||participants|||Number
2818614|NCT00394251|Secondary|Mean Taxane Dose Intensity Per Week|Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.|||mg/m^2/week||Standard Deviation|Mean
2818615|NCT00394251|Secondary|The Cumulative Dose of Taxane Delivered During Study|The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16).|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.|||mg/m^2||Standard Deviation|Mean
2818616|NCT00394212|Secondary|Subjects Achieving 20% Excess Weight Loss at 6 Months|%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100|6 months|ITT, Last Observation Carried Forward|||percentage of participants|||Number
2818617|NCT00394212|Secondary|Subjects Achieving Weight Stabilization at 6 Months|Weight is stabilized if 6 month weight is +/- 2% from baseline weight.|6 months|ITT, Last Observation Carried Forward|||percentage of participants|||Number
2818618|NCT00394212|Secondary|Subjects Achieving 15% Excess Weight Loss (EWL)|%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.|6 months|ITT, Last Observation Carried Forward|||percentage of participants|||Number
2818619|NCT00394212|Primary|Weight Loss (%)|Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100|6 months|ITT using Last Observation Carried Forward (LOCF)|||percentage of weight lost||Standard Deviation|Mean
2818620|NCT00394095|Primary|Change in Body Weight|For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.|12 weeks|Bipolar youth (ages 12-17) who were taking olanzapine (10-20 mg/day) for a manic episode, were given topiramate (300-400mg/day) or comparable dose placebo for 12 weeks. Analysis was per protocol.|||kg||95% Confidence Interval|Mean
2818621|NCT00394095|Secondary|Tolerability of Topiramate|To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.|12 weeks|||||||
2818622|NCT00394095|Primary|Change in Body Mass Index (BMI)|For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.|12 weeks|The analysis was per protocol based on change in BMI over 12 weeks in the Experimental sample (N=16) compared to the Placebo group (N=14).|||kg/m2||95% Confidence Interval|Mean
2818623|NCT00394082|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to patient death from any cause. Patients that did not die were censored at the last known time the patient was alive.|up to 39 months|Treated population|||months||95% Confidence Interval|Median
2818624|NCT00394082|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease is defined in outcome #2. Complete response (CR) and partial response (PR) are defined in outcome #3."|up to 39 months|Treated population of participants who had a response.|||months||95% Confidence Interval|Median
2818625|NCT00394082|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). RECIST defines SD as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease and no new lesions. Definitions for CR and PR can be found in outcome #3.|up to 39 months|Treated population|||percentage of participants||95% Confidence Interval|Number
2818626|NCT00394082|Secondary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response is complete response (CR) + partial response (PR). RECIST defines overall response of CR as the disappearance of all target and non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. Overall response of PR is defined as >= 30% decrease from baseline in the sum of the longest diameters of target lesions and no progression of non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing and no appearance of new lesions. The objective response is determined by combining the response of target and non-target lesions and the appearance of new lesion(s) or not together.|up to 39 months|Treated population.|||percentage of participants||95% Confidence Interval|Number
2818652|NCT00393796|Primary|Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo|"The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.~Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 Months Post Treatment||||percentage of participants||95% Confidence Interval|Number
2818627|NCT00394082|Primary|Kaplan-Meier Estimates for Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a >= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to 39 months|Treated population.|||months||95% Confidence Interval|Median
2818628|NCT00394082|Primary|Participants With At Least One Treatment-Emergent Adverse Event (TEAE)|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.|up to 25 months|Safety population|||participants|||Number
2818629|NCT00393978|Primary|Change in Percent Days of Cannabis Use Per Week|Change in percent days of cannabis use per week from baseline to week 16.|16 weeks||||cannabis use||Standard Deviation|Mean
2818630|NCT00393978|Primary|Change in Joints Per Week|Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.|16 weeks||||joints||Standard Deviation|Mean
2818631|NCT00393939|Secondary|Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score|EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled 'best imaginable health state' and 'worst imaginable health state'. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.|||units on a scale||95% Confidence Interval|Mean
2818632|NCT00393939|Secondary|Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score|EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.|||units on a scale||95% Confidence Interval|Mean
2818633|NCT00393939|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.|||units on a scale||95% Confidence Interval|Mean
2818634|NCT00393939|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline to date of death from any cause (up to Month 33)|ITT population|||months||95% Confidence Interval|Median
2818635|NCT00393939|Secondary|Duration of Response (DR)|DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|Baseline up to Month 33|ITT population. Number of participants analyzed = number of participants with confirmed objective tumor response.|||months||95% Confidence Interval|Median
2818636|NCT00393939|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.|Baseline up to Month 33|ITT population|||percentage of participants|||Number
2818637|NCT00393939|Primary|Progression-Free Survival (PFS)|PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 33|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
2818653|NCT00393718|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.|||number of events per year of exposure|||Number
2825126|NCT00343564|Secondary|Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||ng/mL||Standard Deviation|Mean
2818638|NCT00393913|Primary|Vigilance|Vigilance is measured using the psychomotor vigilance task which is a portable reaction time test that is contained in a small, programmable, portable electronic box that requires only a single switch to start. The task consists of responding to a small bright red light stimulus by pressing a response button as soon as the stimulus appears. This stops the stimulus counter and displays the reaction time (RT) in milliseconds for a 2-second period and the task duration is 20 minutes. The subject is instructed to press the button as soon as each stimulus appears in order to keep the reaction time as low as possible. The PVT yields highly informative metrics on the capacity for sustained attention including the frequency of lapses (reaction time > 500 milliseconds). The higher the number of lapses the greater the impairment. Well rested (non-sleepy) subjects have almost no lapses(<2) during the 20min test.|Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)|Per protocol|||Lapses||Standard Deviation|Mean
2818639|NCT00393913|Primary|Objective Sleepiness|Multiple Sleep Latency Test (MSLT) measures the latency to sleep onset in minutes. The shorter the latency to sleep the more sleepy the subject.|Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)||||minutes||Standard Deviation|Mean
2818640|NCT00393913|Primary|Subjective Sleepiness|Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.|Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)||||units on a scale||Standard Deviation|Mean
2818641|NCT00393887|Primary|Number of Patients With Inguinal Hernia Recurrence||1 year||||participants|||Number
2818642|NCT00393874|Primary|PSQI|"Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality.~A score of < or = to 5 reflects good sleep quality."|Baseline, post, 4 months post-treatment|For the medication arm, 18 participants completed PSQI at screening, 14 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.|||units on a scale||Standard Deviation|Mean
2818643|NCT00393874|Primary|PSG Composite Measure|"Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed.~For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep."|Baseline sleep study and post sleep study|For the medication arm, 18 participants completed a PSG study at baseline and 13 completed a PSG post treatment. For the Behavioral arm, 17 participants completed a PSG at baseline and 12 completed a PSG post-treatment. For the placebo arm, 15 participants completed a PSG at baseline and 12 completed a PSG post-treatment.|||percentage of time asleep vs time in bed||Standard Deviation|Mean
2818644|NCT00393874|Primary|Sleep Diary Measures|"Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed.~Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity."|baseline and post|For the medication arm, 15 participants completed the sleep diary (SD) at baseline and 13 returned a SD post treatment. For the Behavioral arm, 15 participants completed the SD at baseline, and 12 returned it at follow-up. For the placebo arm, 12 participants completed the diary at baseline and 10 returned one at follow-up.|||units on a scale||Standard Deviation|Mean
2818645|NCT00393874|Primary|Insomnia Severity Index|Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score < 8 is considered to reflect no significant insomnia.|Screening, Post, and Follow-up|For the medication arm, 18 participants completed ISI at screening, 15 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.|||units on a scale||Standard Deviation|Mean
2818646|NCT00393861|Secondary|Overall Survival|Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
2818647|NCT00393861|Secondary|Duration of Remission (CR + PR)|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
2818648|NCT00393861|Secondary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|completion of study, up to 5 years|All patients enrolled and received treatment.|||percentage of participants||90% Confidence Interval|Number
2818649|NCT00393861|Primary|Twelve Month Disease-free Survival Rate|The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.|12 month post completion of treatment|All patients enrolled and received treatment.|||percentage of participants||90% Confidence Interval|Number
2818650|NCT00393848|Secondary|Change in Maximal Voluntary Contraction||Baseline and 6 weeks post surgery|Measure not performed in Experiment 2|||kg/kg leg lean mass||Standard Error|Mean
2818651|NCT00393848|Primary|Muscle Protein Synthesis||Perioperative and discharge||||%/d||Standard Error|Mean
2818654|NCT00393718|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||kg||Standard Error|Least Squares Mean
2818656|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818657|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818658|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818659|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818660|NCT00393718|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
2818661|NCT00393718|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL *h||Standard Error|Least Squares Mean
2818662|NCT00393718|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818663|NCT00393718|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||mg/dL||Standard Error|Least Squares Mean
2818664|NCT00393718|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
2818665|NCT00393718|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
2818666|NCT00393705|Secondary|Total Daily Insulin Dose at 4 Weeks and 12 Weeks||4 weeks and 12 weeks|Number of patients who received at least one dose of study drug and had a post-baseline insulin measurement at week 4 and week 12.|||International Units (IU)||Standard Deviation|Mean
2818667|NCT00393705|Secondary|Change From Baseline in Weight at 16 Week Endpoint||Baseline, 16 weeks|Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16.|||kilograms (kg)||Standard Deviation|Mean
2818668|NCT00393705|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.|||number of events per 30 days||Standard Deviation|Mean
2818683|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until Week 96|Randomized participants who received at least 1 dose of study drug and who were evaluable.|||Participants|||Number
2818669|NCT00393705|Secondary|Number of Patients With Self-reported Hypoglycemic Episodes|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.|||participants|||Number
2818670|NCT00393705|Secondary|Mean Daily Blood Glucose Values at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline blood glucose reading at week 16 for the respective variable.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2818671|NCT00393705|Secondary|Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial blood glucose reading after the midday meal at week 16.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2818672|NCT00393705|Secondary|2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial plasma glucose reading after the midday meal at week 16.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2818673|NCT00393705|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint||Baseline, 16 Weeks|Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint.|||percent HbA1c||Standard Deviation|Mean
2818674|NCT00393705|Secondary|Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint.|||percentage of participants|||Number
2818675|NCT00393705|Primary|Hemoglobin A1c (HbA1c) at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint.|||percent HbA1c||Standard Deviation|Mean
2818676|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2818677|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2818678|NCT00393523|Secondary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||Participants|||Number
2818679|NCT00393523|Primary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.|||Participants|||Number
2818680|NCT00393510|Secondary|Time of Ulcer Healing|Time taken for maturation of granulation to enable skin grafting.|24 week||||Weeks||Standard Deviation|Mean
2818681|NCT00393510|Secondary|Tumour Necrosis Factor-alpha Levels in Serum|The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.|Baseline and 4 week||||pg/mL||Standard Deviation|Mean
2818682|NCT00393510|Primary|Number of Participants With Limb Salvage|The number of successful limb rescued (without amputation).|24 weeks||||Participants|||Number
2818684|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Start of dosing (Day 1) until end of treatment (Week 240) + 5 days|Participants who were randomized and received at least 1 dose of study drug|||Participants|||Number
2818685|NCT00393484|Secondary|Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96|Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).|At 96 weeks|All participants who received study drug and who had samples of measureable HBV DNA values|||Participants|||Number
2818686|NCT00393484|Secondary|Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240|Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay|At Weeks 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug|||Percetage of participants|||Number
2818687|NCT00393484|Secondary|Number of Participants With Virologic Rebound at Week 24|Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).|At Week 24||||Participants|||Number
2818688|NCT00393484|Secondary|Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24|Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
2818689|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
2818690|NCT00393484|Secondary|Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24|ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
2818691|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Treated cohort: includes participants who are randomized and received at least 1 dose of study drug (ETV or LVD).|||Participants|||Number
2818692|NCT00393484|Secondary|Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96|Normalization of serum ALT= ≤*institutional upper limit of normal.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
2818693|NCT00393484|Secondary|Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24|Mean ALT values from baseline by laboratory test. .|At Week 24|Randomized participants who received at least 1 dose of study drug|||U/L||Standard Deviation|Mean
2818694|NCT00393484|Secondary|Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240|Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.|At Weeks 24, 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug|||log10 copies/mL||Standard Deviation|Mean
2818695|NCT00393484|Secondary|Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96|The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug|||Participants|||Number
2818696|NCT00393484|Primary|Percentage of Participants Who Achieved a Virologic Response at Week 24|Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.|At Week 24|Randomized participants who received at least 1 dose of study drug|||Percentage of participants|||Number
2818713|NCT00393367|Secondary|Number of Subjects Remaining in the Severe Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.|||Participants|||Number
2818697|NCT00393458|Secondary|Percentage of Days of Poor Control During 52 Weeks of Treatment|Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Baseline to end of study (Week 52)|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.|||Percentage of days||Standard Error|Least Squares Mean
2818698|NCT00393458|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Week 12 + 1 day, Day 85|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.|||Liters||Standard Error|Least Squares Mean
2818699|NCT00393380|Secondary|Disease-free Survival|Disease-free survival|Measured at 1 year|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
2818700|NCT00393380|Secondary|Overall Survival|Overall Survival|Measured at 2 years|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
2818701|NCT00393380|Secondary|Cumulative Incidence of Relapse|Cumulative Incidence of Relapse|Measured at 2 years|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
2818702|NCT00393380|Secondary|100-day Transplant-related Mortality|100-day transplant-related mortality|Measured at Day 100|13 patients were transplanted|||participants|||Number
2818703|NCT00393380|Secondary|Platelet Engraftment (Greater Than 20,000)|Platelet engraftment (greater than 20,000)|Measured at Day 180|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
2818704|NCT00393380|Secondary|Cumulative Incidence of Chronic GVHD|Cumulative Incidence of Chronic GVHD|Measured at 2 years|13 patients were transplanted.|||percentage of participants||95% Confidence Interval|Number
2818705|NCT00393380|Secondary|Cumulative Incidence of Acute GVHD Grades II-IV at Day 100|Cumulative Incidence of Acute GVHD Grades II-IV at day 100|Measured at Day 100|13 patients were transplanted|||percentage of participants||95% Confidence Interval|Number
2818706|NCT00393380|Primary|Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)|Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)|Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.|13 patients received the transplant.|||days||Full Range|Median
2818707|NCT00393367|Secondary|Serious Adverse Events|Serious Adverse Events|0-5 days|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.|||participants|||Number
2818708|NCT00393367|Secondary|Number of Participants With Adverse Events (Non-serious).||within 30 days of the ED visit|Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group.|||Participants|||Number
2818709|NCT00393367|Primary|Mean Change in Asthma Score at 2 Hours|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).|||Units on a scale||95% Confidence Interval|Mean
2818710|NCT00393367|Secondary|Relapse / Readmission Numbers.|Participants admitted to the hospital within 5 days of the ED visit|within 5 days of ED visit|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.|||Participants|||Number
2818711|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Mild Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.|||Participants|||Number
2818712|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.|||Participants|||Number
2818714|NCT00393367|Secondary|Oxygen Saturation.|Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.|2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator||||Percent Hemoglobin Saturation||95% Confidence Interval|Mean
2818715|NCT00393367|Secondary|Mean Change in Respiratory Rate.|Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.|Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator||||Breaths per minute||95% Confidence Interval|Mean
2818716|NCT00393367|Secondary|Change in Mean Heart Rate|Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol|From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator||||Beats per minute||95% Confidence Interval|Mean
2818717|NCT00393367|Secondary|Number of Patients Hospitalized|The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.|within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo||||Participants|||Number
2818718|NCT00393367|Primary|Median Change in Asthma Score 2 Hours After Intervention|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).|||Units on a scale||Full Range|Median
2818719|NCT00393094|Primary|Radiographic Response Rate (Glioblastoma Multiforme Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)||||Percent of participants|||Number
2818720|NCT00393094|Primary|Radiographic Response Rate (Anaplastic Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.|||Percent of participants|||Number
2818721|NCT00393094|Primary|Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.|Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.|||Participants|||Number
2818722|NCT00393094|Primary|Radiographic Response Rate (Malignant Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.|||Percent of participants|||Number
2818723|NCT00393068|Secondary|Overall Survival||32 months|||||||
2818724|NCT00393068|Secondary|Progression-Free Survival||32 months|||||||
2818725|NCT00393068|Primary|Pathologic Complete Response (pCR) Rate||18 months||||participants|||Number
2818726|NCT00393042|Secondary|Weiss Functional Impairment Rating Scale (WFIRS)|The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score.|8-10 weeks|The number of participants analyzed differs from the participant flow in all of the groups besides the Adderall XR - 10mg group because the WFIRS was not completed for every participant.|||units on a scale||Standard Deviation|Mean
2818727|NCT00393042|Secondary|Clinical Global Impression - Severity|The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|8-10 weeks|The number of participants analyzed differs from the participant flow in the Focalin XR groups because the CGI-S was not completed for every participant. The same is true for the Adderall XR - 25/30mg group.|||units on a scale||Standard Deviation|Mean
2818728|NCT00393042|Secondary|Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms|Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|8-10 weeks|The number of participants analyzed differs from the participant flow because some participants refused to provide a DNA sample for analysis or some participants did not have the allele type that was being observed. Of those that provided a DNA sample, 6 had the 9/9 allele on the DAT 1 gene, 15 had the 9/10 allele and 30 had the 10/10 allele.|||units on a scale||Standard Deviation|Mean
2818729|NCT00393042|Secondary|ADHD Parent Rating Scale-IV|Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.|completed weekly over 8-10 weeks||||units on a scale||Standard Deviation|Mean
2818730|NCT00393042|Primary|Sleep Duration|Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.|8-10 weeks|participants with sufficient sleep actigraphy data for analysis (n=37)|||minutes||Standard Deviation|Mean
2818731|NCT00393042|Primary|Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.|Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.|8-10 weeks|Subjects with complete and valid actigraphy (n = 37) and sleep diaries were used to calculate sleep onset latency and sleep duration.|||HHMM.SS||Standard Deviation|Mean
2818732|NCT00393029|Secondary|In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants|Survival of TCR gene-engineered cells is defined as >10% murine TCR positive cells.|3-12 months||||participants|||Number
2818733|NCT00393029|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module.|events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.||||participants|||Number
2818734|NCT00393029|Primary|Clinical Tumor Regression|"Response Evaluation Criteria In Solid Tumors (RECIST).~See the protocol Link module for full criteria if desired."|1-11 months||||Participants|||Number
2818735|NCT00392990|Secondary|Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen|Progression Free Survival (PFS) will be defined from the first dose of study drug to the first documentation of progressive disease or death for any reason. Patients that are lost to follow-up before progression will be censored at the point of last documentation of not experiencing the event.|At 2 years from treatment initiation. Median follow up 34 months (range 15-45)|Evaluable patients for this outcome measure and were reported on together and in stratified group: high-risk and low-risk|||percentage of patients progression free|||Number
2818736|NCT00392990|Secondary|Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)|"Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months.~In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.|All patients that receive at least one dose of study drug are evaluable for this outcome measure|||participants|||Number
2818737|NCT00392990|Secondary|Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen|Overall Survival (OS) of patients with Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen. OS is defined from the first dose of study drug to the time of death for any reason.|At 2 years from treatment initiation Median follow up 34 months (range 15-45)|Evaluable patients for this outcome measure and were reported on together and in stratified group: high-risk and low-risk|||percentage of patients alive|||Number
2818738|NCT00392990|Primary|Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen|"Response Rate is defined as combined number of patients with Complete Remission (CR) Complete Remission undetermined (Cru) and Partial Remission (PR) for patients with Burkitt's and Burkitt-like Lymphoma/Leukemia. Response will be measured by CT scans following treatment completion and assessed using Response Criteria for Non-Hodgkin's Lymphoma where:~CR=complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.~CRu=same as above but allowing for 75% decrease in lymph node masses and indeterminate or normal bone marrow.~PR=50% decrease in SPD of the six largest dominant nodes or nodal masses with no increase in size or other nodes, liver, spleen and no new sites of disease."|After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks.|One patient was determined not to be evaluable for response as he did not complete 2 cycles that were required per protocol to be evaluable for this outcome measure|||percentage of patients|||Number
2818739|NCT00392951|Secondary|Number of Participants With Lymphoproliferation Response to Oral Sirolimus|Complete response (CR) is complete resolution of any lymphadenopathy and splenomegaly for at least two months. Partial response (PR) is a reduction in size of at least 50% of lymphadenopathy or splenomegaly for at least two months. No response (NR) is no change or < 50% reduction in lymphadenopathy or splenomegaly. Progressive Disease (PD) is obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug. Not Applicable (N/A) is there is no evidence of disease (No pathologic lymphadenopathy or splenomegaly at time of enrollment).|6 months|Number analyzed per row reflects number of participants with each condition|||Participants|||Count of Participants
2818740|NCT00392951|Secondary|Effect of Sirolimus on Intracellular Targets|Needs more specific information|6 months|This was an optional assessment- there was no enrollment. Data were not collected.||||||
2818741|NCT00392951|Secondary|Trough Levels Produced by Administration of Oral Sirolimus|Pharmacokinetic levels produced by administration of oral sirolimus|Within first 5 days of starting sirolimus||||nanograms/dL||Full Range|Mean
2818742|NCT00392951|Secondary|Number of Participants With Autoimmune Disease Response to Oral Sirolimus|Complete response (CR) is complete resolution in all autoimmune cytopenias (neutropenia, anemia thrombocytopenia) maintained for more than two months, combined with an ability to wean off corticosteroids and/or other immunosuppressive medication. Partial response (PR) is improvement in any cytopenias by at least one grade, lasting more than two months, without worsening any other cytopenias or stable disease with the ability to wean corticosteroids and/or immunosuppressive medications by at least 50%. No response (NR) is no change in cytopenias with treatment, and the inability to wean corticosteroids or other immunosuppressive medications. Progressive disease (PD) refers to obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug.|6 months|Number analyzed per row reflects number of participants with each condition|||Participants|||Count of Participants
2818743|NCT00392951|Primary|Number of Participants With Grade 3 and 4 Toxicities of Administration of Oral Sirolimus|"Grade 3 toxicities are those that are considered severe or medically equivalent requiring hospitalization or prolonged hospitalization (according to CTCAE criteria 3.0).~Grade 4 toxicities are those that are life-threatening (urgent intervention indicated) (according to CTCAE criteria 3.0)."|6 months||||participants|||Number
2818744|NCT00392925|Secondary|Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population|Serum titer determinations for antibodies to leptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to leptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline. All participants were evaluated (including those who did not receive metreleptin as their randomized study drug). Baseline was Day 1 (randomization).|Baseline up to Week 16|The Intent-To-Treat (ITT) Population includes all randomized participants who received at least 1 injection of any component of the randomized study medication; n=number with non-missing data at visit in each treatment group.|||participants|||Number
2818745|NCT00392925|Secondary|Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population|A 12-Lead electrocardiogram (ECG) was obtained at Week -4, Day 1, Week 16, Week 20 or early termination and the overall interpretation of the ECG was made by the investigator as normal, abnormal (not clinically significant) and abnormal (clinically significant). The ECG consisted of the PR interval = time from beginning of the P wave to the beginning of the QRS complex; (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS (time from the beginning to the end of the QRS complex) interval; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). .|Weeks 16, 20, early termination|All participants who were enrolled and randomized and had ECGs performed at Weeks 16, 20, or early termination. n=number of participants with ECGs at visit by treatment group.|||participants|||Number
2818759|NCT00392925|Secondary|LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population|Screening (Week -5 or -6) was the first visit for a participant. This first visit determined participant eligibility and occurred prior to enrollment (Week -4). Hip circumference was measured in centimeters (cm).|Screening up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Those excluded from the Evaluable Population were identified prior to the unblinding process. Number with non-missing anthropometric data in each treatment group were analyzed.|||cm||Standard Error|Least Squares Mean
2818746|NCT00392925|Secondary|Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population|Number of laboratory values of potential clinical importance (not participants) observed. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Time frame of evaluation differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing vital signs data at Week -4. n=number with non-missing data in each treatment group|||participants|||Number
2818747|NCT00392925|Secondary|Number of Chemistry Values of Potential Clinical Importance - Enrolled Population|Number of values (not participants). Greater than (>), Less than (<), high (H), low (L). Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin H > 2 mg/dL; glucose fasting or non-fasting H >200 mg/dL, L <60 mg/dL; Albumin L <2.5 g/dL; Creatine Phosphokinase (CPK) H >3*Upper limit of Normal (ULN); Sodium L<130 milliequivalents per liter (mEq/L), H >150 mEq/L; potassium L<3.0 mEq/L, H>5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8 mg/dL, H>11 mg/dL; triglycerides H>500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H >3*ULN; Gamma-glutamyltransferase (GGT) H>3*ULN; creatinine males >1.6 mg/dL, females >1.4 mg/dL; alanine aminotransferase (ALT) H >3*ULN; aspartate aminotransferase (AST) H >3*ULN; urea nitrogen H >45 mg/dL; uric acid males >10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L <1.0 mg/dL H >6.0 mg/dL. Time frame differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing data at Week -4. n=number with non-missing data in each treatment group who were in the analysis.|||laboratory values|||Number
2818748|NCT00392925|Secondary|Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population|Enrollment was Visit 2 (Week -4). Heart rate was measured after the participant rested for 5 minutes and was sitting. Heart Rate was measured in beats per minute (bpm). Vital signs were taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT: those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.|||beats/min||Standard Deviation|Mean
2818749|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population|Enrollment was Visit 2 (Week -4). Blood pressure (BP) was measured after 5 minutes of quiet rest with the participant in a sitting position and was measured in millimeters of mercury (mm Hg). Blood pressure was taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT:those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.|||mm Hg||Standard Deviation|Mean
2818750|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The lower the score the more improvement a participant shows.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number with non-missing data in each treatment group were analyzed (n).|||units on a scale||Standard Error|Least Squares Mean
2818751|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO for eating behavior: Binge Eating Scale (BES) Total Score (16-item questionnaire assessed the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Minimum and maximum scores were 0 and 55, respectively); Susceptibility to Eating Questionnaire (SEQ) Total Score (measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale [ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong]. Responses to these items rated over the past 7 days;|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.|||units on a scale||Standard Error|Least Squares Mean
2818797|NCT00392678|Secondary|Safety and Tolerability|See adverse event module for details. Safety and tolerability of salsalate compared to placebo as assessed by adverse events.|14 weeks||||participants|||Number
2818752|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO: Total Score in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite), 31-item instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items range from 1 to 5 with 5=always true and 1= never true. Total score measured on scale from 0 (worst) to 100 (best). Higher scores indicate improvement; Profile of Mood States (POMS), 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. Factor scores added for total score. Lower score indicates improvement. 0=best outcome; 120=worst outcome.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. (POMS)n=19, 38, 36; (IWQOL-Lite)n=19, 38, 36|||units on a scale||Standard Error|Least Squares Mean
2818753|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Total insulin was measured in micro international units per milliliter (µIU/mL)|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.|||µIU/mL||Standard Deviation|Mean
2818754|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting total plasma amylin (peptide produced by beta cells in the pancreas) concentration was measured in picomolar (pM) and samples were obtained at screening, enrollment, baseline, Week 4 and Week 16.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number analyzed with non-missing data at visit.|||pM||Standard Deviation|Mean
2818755|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Leptin was measured in nanograms per milliliter (ng/mL). Plasma total leptin (including endogenous leptin and exogenous metreleptin) concentrations were measured using a validated sandwich-type immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. This assay is not specific for metreleptin and detects both endogenous leptin and exogenous recombinant-methionyl human leptin [metreleptin]).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.|||ng/mL||Standard Deviation|Mean
2818756|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting Lipids included: total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and Triglycerides. Fasting Glucose and Lipids were measured in milligrams per deciliter (mg/dL).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data for lipids and glucose in each treatment group.|||mg/dL||Standard Deviation|Mean
2818757|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were obese at enrollment were still obese at Week 20 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were overweight at enrollment were still overweight at Week 20 or if they had changed to normal (or obese).|Enrollment up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 20 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 20.|||participants|||Number
2818758|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were obese at enrollment were still obese at Week 16 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were overweight at enrollment were still overweight at Week 16 or if they had changed to normal (or obese).|Enrollment up to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 16.|||participants|||Number
2818798|NCT00392678|Secondary|Change From Baseline in 14-week Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in insulin from Baseline to Week 14 in data table below.|Baseline, week 14||||pmol/l||Inter-Quartile Range|Median
2818760|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Baseline was Visit 4 (Day 1 of randomization period). Waist circumference was measured in centimeters (cm).|Baseline to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.|||cm||Standard Error|Least Squares Mean
2818761|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Waist circumference was measured in centimeters (cm). Least Squares mean = LS mean. Enrollment was Visit 2 (Week -4) which was the start of the 4 week Lead-In Period. At Day 1, the participant was randomized to one of the 3 study arms and the participant was treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.|||cm||Standard Error|Least Squares Mean
2818762|NCT00392925|Secondary|LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population|Excess body weight: the difference between a participant's actual body weight and the weight a participant of his/her height would have if his/her BMI were 24.9 kg/m2. Excess body weight at a given visit was calculated as body weight in kilograms (kg) at that visit minus 24.9 × height in meters (m)^2 or 0, whichever was greater. If a participant achieved a normal BMI (24.9 kg/m^2), that subject was considered to have no excess weight. Additional weight loss that occurred after a normal BMI was achieved was not included in the calculation of excess weight loss. Enrollment was Visit 2 (Week -4), the start of the Lead-In Period. Baseline was Day 1 of the randomization to a study arm.|Enrollment to Baseline|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. Number with non-missing body weight data at Day 1 of Randomization were analyzed.|||percentage of change||Standard Error|Least Squares Mean
2818763|NCT00392925|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population|Baseline refers to Visit 4 (Day 1 of randomization period). Number of participants with 5% or more and 10% or more change in weight from baseline at each visit. Number of participants with 5% or more change in weight that was sustained through Week 16. Number of participants with 10% or more change in weight that was sustained through Week 20.|Baseline to Weeks 16 and Weeks 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||participants|||Number
2818764|NCT00392925|Secondary|Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population|Initial (Day 1 through Week 12), late (Week 12 through Week 20), and overall (Day 1 through Week 20) rates of Least squares (LS) mean absolute change in body weight were defined by the slopes of the regression lines fitted to the observed body weights during the periods from Baseline (Day 1) through each visit to Week 20. Initial, late and overall absolute change was measured in kilograms of body weight per week (kg/week). Baseline refers to Visit 4 (Day 1 of randomization period).|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process.|||kg/week||Standard Error|Least Squares Mean
2818765|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change is percentage that body weight changed over time at each visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||percentage of change||Standard Error|Least Squares Mean
2818766|NCT00392925|Secondary|LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean change in body weight as measured in kilograms (kg) from enrollment to each study visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and the participant was treated as per that arm up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||kg||Standard Error|Least Squares Mean
2818767|NCT00392925|Secondary|LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population|Least Squares (LS) mean absolute change in body weight as measured in kilograms (kg) from baseline to Weeks 4, 8, 12, 20. Baseline defined as Day 1 of randomized treatment|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||kg||Standard Error|Least Squares Mean
2818768|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change in body weight from baseline to Weeks 4 through 20. Baseline defined as Day 1 of randomized treatment.|Baseline up to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.|||percentage of change||Standard Error|Least Squares Mean
2825127|NCT00343564|Secondary|Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||hr||Standard Deviation|Mean
2818769|NCT00392925|Primary|Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population|Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment.|Baseline to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Participants excluded from the Evaluable Population were identified prior to the unblinding process. n=number with non-missing body weight data at Week 16 in each treatment group.|||kg||Standard Error|Least Squares Mean
2818770|NCT00392860|Primary|Change in Functional Status Score|The Functional Status Scale, which measures hand and wrist symptoms.|Baseline, 4 Months|Zero participants were analyzed because only 4 participants were enrolled in this trial. Analyzing the results would not result in any meaningful information. The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.||||||
2818771|NCT00392834|Secondary|Correlation of EBV Load Measurements With OS, FFS, and EFS||baseline through 2 years post-treatment|||||||
2818772|NCT00392834|Secondary|Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS||baseline through 2 years post-treatment|||||||
2818773|NCT00392834|Secondary|Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results||baseline|||||||
2818774|NCT00392834|Secondary|Utility of Flow Cytometry in Detecting Leptomeningeal Disease||baseline and 6-8 weeks post-treatment|||||||
2818775|NCT00392834|Secondary|Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS||baseline through 2 years post-treatment|||||||
2818776|NCT00392834|Secondary|Incidence of Infection-related Deaths||baseline through 2 years post-treatment|||||||
2818777|NCT00392834|Secondary|Toxicity||baseline through 2 years post-treatment|||||||
2818778|NCT00392834|Secondary|Event-free Survival (EFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years|||||||
2818779|NCT00392834|Secondary|Failure-free Survival (FFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years|||||||
2818780|NCT00392834|Secondary|Complete Response Rate||6-8 weeks post treatment, every 4 months post-treatment for 2 years|||||||
2818781|NCT00392834|Primary|Overall Survival (OS) at 1 Year||1 year post treatment||||Cumulative proportion surviving at 1 yr||95% Confidence Interval|Number
2818782|NCT00392821|Secondary|Progression-Free Survival.|Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions.|18 months||||Months||95% Confidence Interval|Median
2818783|NCT00392821|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months||||percentage of evaluable patients||95% Confidence Interval|Number
2818784|NCT00392808|Primary|Serum Antibody Titers Against Haemophilus Influenzae Type b.||One year||||GMCs||95% Confidence Interval|Geometric Mean
2818785|NCT00392808|Primary|Serum Bactericidal Activity Against MenC||One month after booster dose||||GMTs||95% Confidence Interval|Geometric Mean
2818786|NCT00392782|Secondary|Overall Survival|Number of patients who were deceased at 1 year post transplant.|1 Year||||Participants|||Number
2818787|NCT00392782|Secondary|Transplant-related Mortality|Number of patients with treatment related death at 1 year post transplant.|1 Year||||Participants|||Number
2818788|NCT00392782|Secondary|Incidence of Graft Failure|Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.|Day 100||||Participants|||Number
2818789|NCT00392782|Secondary|Incidence of Chronic Graft-versus-host Disease (GVHD)|"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD."|1 Year||||Participants|||Number
2818790|NCT00392782|Secondary|Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)|"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening."|Day 100||||Participants|||Number
2818791|NCT00392782|Secondary|Incidence of Disease Relapse|Number of patients with disease at 1 year.|1 Year||||Participants|||Number
2818792|NCT00392782|Primary|Incidence of Disease-free Survival|Number of patients alive and without disease at 1 year after transplant.|1 Year||||Participants|||Number
2818793|NCT00392769|Primary|Overall Disease Control Rate|Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.|Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.|There were ten inevaluable participants (completing less than 1 cycle).|||percentage of participants|||Number
2818794|NCT00392704|Secondary|Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|24 Months||||percentage of patients|||Number
2818795|NCT00392704|Primary|Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment|The percentage of patients estimated to be alive 2 years after beginning protocol treatment|24 months|All participants in this study were assessed and included in the progression free survival analysis|||percentage of participants|||Number
2818796|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in C-peptide from Baseline to Week 14 is in the data table below|Baseline, week 14||||C-peptide in nmol/l||95% Confidence Interval|Mean
2818799|NCT00392678|Secondary|Change in Lipids|"Change in lipids (low-density lipoprotein cholesterol [LDL-C], non-high-density lipoprotein cholesterol [non-HDL-C], triglycerides [TG], total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], TC/HDL-C ratio, and LDL-C/HDL-C ratio)~LDL-C/HDL-C ratio not calculated"|14 week||||mg/dl||95% Confidence Interval|Mean
2818800|NCT00392678|Secondary|Change From Baseline and Trends in Fasting Glucose Over Time||14 week||||mg/dl||95% Confidence Interval|Mean
2818801|NCT00392678|Secondary|Change in HbA1c|Change from baseline to either 14 or 26 weeks, or last HbA1c measurement prior to rescue therapy|14 week||||% HbA1c||95% Confidence Interval|Mean
2818802|NCT00392678|Primary|Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1|The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 14 (stage 1) in the intent-to-treat (ITT) population with last observation carried forward.|14 week||||% (units of HbA1c)||95% Confidence Interval|Mean
2818803|NCT00392665|Secondary|Number of Participants With Toxicities According to Severity|Toxicities by Grades 1 or 2 and Grades 3 or 4 in each arm. Grade 4 = life-threatening, Grade 3 = serious, Grade 2 = moderate, Grade 1 = Mild|2 years||||Participants|||Count of Participants
2818804|NCT00392665|Secondary|Duration of Overall Survival|Median overall survival (OS), determined by the Kaplan-Meier method.|2 years||||months||95% Confidence Interval|Median
2818805|NCT00392665|Secondary|Overall Response Rate (ORR)|"Overall response rate (complete plus partial response=ORR), as determined by RECIST.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|Two of eighteen patients in both arms had radiographic partial responses, for an overall response rate of 11% for both arms, (95% CI 1.2%, 34.7%). The identical results below are not typos or placeholder values.|||percentage of participants||95% Confidence Interval|Number
2818806|NCT00392665|Primary|Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival.|The primary outcome will be measured by median progression-free survival (PFS), determined by the Kaplan-Meier method for both Arm A and Arm B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|1 year||||months||95% Confidence Interval|Median
2818807|NCT00392496|Primary|Objective Tumor Response|It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma and reviewed independently|Up to 3 years|patients evaluable for response|||participants|||Number
2818808|NCT00392444|Primary|Objective Response (Partial and Complete) Per RECIST|Number of patients who had objective responses after radiology review|Up to 3 years|1 cancelled patient and 4 ineligible patients were excluded from analysis.|||participants|||Number
2818809|NCT00392392|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery|Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).|18 months|Two patients refused surgery after completing six cycles of pre-operative (neoadjuvant) therapy.|||percentage of participants|||Number
2818810|NCT00392379|Secondary|Prolonged Smokeless Tobacco Abstinence at 6 Months|Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).|6 months||||Participants|||Number
2818811|NCT00392379|Secondary|Self-reported Point Prevalence All Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.|3 months||||Participants|||Number
2818812|NCT00392379|Primary|Prolonged Smokeless Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.|3 months|ITT|||Participants|||Number
2818813|NCT00392288|Secondary|Change From Baseline in Use of Albuterol/Salbutamol at Week 12.|Change in albuterol/salbutamol use from baseline to week 12|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.|||Puffs per day||Standard Error|Least Squares Mean
2818814|NCT00392288|Secondary|Change From Baseline in Total Daily Asthma Symptom Score at Week 12.|Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2818815|NCT00392288|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.|Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and <12 years.|||Percent of predicted FEV1||Standard Error|Least Squares Mean
2818816|NCT00392236|Primary|Percent of Prescribed Medication Taken as Assessed by the Medication Event Monitoring System (MEMS)|Estimated percent of prescribed medication taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts).|Measured at Month 6||||percentage of prescribed medication take||Standard Deviation|Mean
2818817|NCT00392223|Secondary|Change From Baseline in Acne Graded by Leeds Technique|Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).|||score on scale||95% Confidence Interval|Mean
2818818|NCT00392223|Primary|Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 EOT|Per Protocol population|||score on scale||95% Confidence Interval|Least Squares Mean
2818819|NCT00392223|Secondary|Improvement of Global Acne Grading System (GAGS) Score|Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 - 75%; Moderate improvement : reduction score > 25 - 50%; Light improvement : reduction score > 0 - 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.|Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.|||participants|||Number
2818820|NCT00392223|Post-Hoc|Number of Subjects With Mild, Moderate, and Severe Acne|Global Acne Grading System score used to assess 6 locations on face/chest/upper back; factor for each based on area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on sum of local scores and se verity: 0=no acne, 1-18=mild, 19-30=moderate, 31-38=severe, >39=very severe.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.|||participants|||Number
2818821|NCT00392223|Secondary|Change From Baseline in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).|||score on scale||95% Confidence Interval|Mean
2818822|NCT00392223|Primary|Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set, Last Observation Carried Forward (LOCF)|||score on scale||95% Confidence Interval|Least Squares Mean
2818823|NCT00392210|Primary|Number of Participants Who Passed Bladder Trial|Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).|postoperatively after surgery on day1 or 2||||participants|||Number
2818824|NCT00392197|Secondary|HbA1c|The number of subjects with an HbA1c value of 6.5% or higher were calculated. In addition, for 5.8% and above, the number of subjects were also calculated, in the same way|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation||||participants|||Number
2818825|NCT00392197|Primary|Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)|The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way.|Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation|Subjects who were treated with at least 1 tablet of the test product, and whose blood glucose level was measured at least once after test product administration were included in the glucose metabolism analysis set. However, subjects who violated inclusion criteria and exclusion criteria were excluded.|||participants|||Number
2818826|NCT00392171|Primary|Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.|Progression-free survival as determined by Kaplan-Meier method.|6 months|"Participants who received allocated intervention.~The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined)."|||Percentage of Participants|||Number
2818827|NCT00392054|Secondary|Quality of Life EQ-5D Visual Analog Score|The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale measures how good/bad one's own health is today, in one's own opinion. 0 means the worst imaginable state of health; 100 means the best imaginable state of health.|Measured At 12 months after randomization|Participants with EQ5D VAS completed at 12 months after randomization.|||score on a scale||Inter-Quartile Range|Median
2818828|NCT00392054|Secondary|Quality of Life EQ5D Index Score|The standard EQ-5D questionnaire is completed by study participants. The EQ-5D Index score is a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Self-reported severity for each dimension is given on a 3 level scale: (1) no problems, (2) some problems or (3) major problems. For example a health state: 11223 means: no problems with mobility (1), no problems with self-care (1), some problems with performing usual activity (2), moderate pain/discomfort (2), and major anxiety/depression (3). Thus there are 243 patterns of health state: 11111 to 33333. Scores are converted to a single weighted index score (utility). The index score is derived by applying a formula as developed by Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005; 43(3): 203-220. The final score has a minimum value of 0 and maximum value of 1 (no problems).|Measured at 12 months after randomization|EQ-5D completed at 12 months|||Index score||Inter-Quartile Range|Median
2818829|NCT00392054|Secondary|Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically|Including only events documented by 12 lead ECG, Holter monitoring or rhythm strips but excluding TTM monitoring. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).|During 21 month follow-up period|All patients randomized|||participants|||Number
2819136|NCT00390299|Other Pre-specified|CEA Titers|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Up to 15 years|||||||
2818830|NCT00392054|Secondary|Episodes of ANY Recurrence of Atrial Tachyarrhythmia|Including all episodes of symptomatic or asymptomatic atrial fibrillation, atrial flutter and atrial tachycardia. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).|During 21 month follow-up period|All patients randomized|||Episodes|Number of ECGs Adjudicated||Number
2818831|NCT00392054|Secondary|Number of Participants With Recurrence of Symptomatic Atrial Fibrillation|Including only symptomatic episodes of atrial fibrillation in the outcome measure (excluding asymptomatic events and events adjudicated as atrial flutter or atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).|During 21 month follow-up period|All patients randomized|||participants|||Number
2818832|NCT00392054|Secondary|Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia|Including only symptomatic episodes of all atrial tachyarrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).|21 months of follow-up|All patients randomized|||participants|||Number
2818833|NCT00392054|Primary|Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm|"Ablation arm cluster: death, cardiac tamponade, severe PV stenosis>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation.~Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation > 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation."|Assessed during entire 24 month study period|All patients treated|||Participants|||Count of Participants
2818834|NCT00392054|Primary|Number of Participants With Recurrence of Atrial Tachyarrhythmia|Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).|Assessed during 21 month follow-up period|All randomized patients|||Participants|||Count of Participants
2818835|NCT00391989|Secondary|OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.||End of study|||||||
2818836|NCT00391989|Secondary|the Cumulative Incidence of Relapse;||End of study|||||||
2818837|NCT00391989|Secondary|DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;||End of study|||||||
2818838|NCT00391989|Secondary|the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study|||||||
2818839|NCT00391989|Secondary|The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study|||||||
2818840|NCT00391989|Secondary|The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;||End of study|||||||
2818841|NCT00391989|Primary|Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).||End of the study, up to day 85||||Patients|||Number
2818842|NCT00391976|Secondary|Number of Participants Hospitalized for Pulmonary Exacerbations|Core study defined as from Baseline through to one month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group). Follow-up phase began at the end of the core study through to the end of the study (Month 27).|From Baseline to end of study (27 months)|All patients who were randomized and received at least one dose of study medication. Non-randomized patients were not included in the analysis.|||Participants|||Number
2818843|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Having an Increased, Decreased, or Unchanged Tobramycin Minimum Inhibitory Concentration (MIC) Value at the Final Visit Compared to Baseline|The percentage of patients with changes in tobramycin MIC values from Baseline to the final visit could not be compared as there was insufficient data.|From Baseline to the final visit (end of the study, Month 27)|Safety population: All patients who were enrolled in the study and received at least 1 dose of study medication.|||Percentage of participants|||Number
2818844|NCT00391976|Secondary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (New or Same Genotype) in Sputum or Deep Throat Cough Swab Based on Confirmatory Assessment by the Central Laboratory|Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.|||Months||95% Confidence Interval|Median
2818845|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Eradicated From Deep Throat Cough Swab or Sputum|One month after the end of treatment was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.|||Percentage of participants|||Number
2818857|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding|Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.|||Participants|||Number
2818846|NCT00391976|Primary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab|Microbiological samples were obtained from sputum or by deep throat cough swab technique. Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group. Kaplan-Meier estimates were used.|From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.|||Months||95% Confidence Interval|Median
2818847|NCT00391898|Secondary|Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3|The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Positive answers||Standard Deviation|Mean
2818848|NCT00391898|Secondary|Patient and Investigator Global Evaluation of the Patient|Both the patient and the investigator made an evaluation of the change in the patient's condition by rating the condition of the patient at the end of the study compared to patient's condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
2818849|NCT00391898|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3|The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
2818850|NCT00391898|Secondary|Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3|Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
2818851|NCT00391898|Secondary|Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient's motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
2818852|NCT00391898|Secondary|Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient's mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF|||Units on a scale||Standard Deviation|Mean
2818853|NCT00391898|Primary|Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with the last observation carried forward (LOCF)|||Units on a scale||Standard Deviation|Mean
2818854|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.|1-week period following randomization|Patients who were monitored for one week following randomization (and for one week one month later).|||Participants|||Number
2818855|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.|1-week period following randomization|Participants with Holter data in the week after Randomization|||Participants|||Number
2818856|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding|Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.|||Participants|||Number
2818858|NCT00391872|Secondary|Participants With Non-procedural Major Bleeding|Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
2818859|NCT00391872|Secondary|Participants With Major or Minor Bleeding|Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
2818860|NCT00391872|Secondary|Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding|Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
2818861|NCT00391872|Secondary|Participants With Death From Any Cause|Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818862|NCT00391872|Secondary|Participants With Stroke|Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818863|NCT00391872|Secondary|Participants With Death From Vascular Causes|Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818864|NCT00391872|Secondary|Participants With MI Event|Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818865|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.|Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818866|NCT00391872|Secondary|Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke|Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818867|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The subgroup of patients with intent for invasive management at randomization|||Participants|||Number
2818868|NCT00391872|Primary|Participants With Any Major Bleeding Event|Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug|||Participants|||Number
2818869|NCT00391872|Primary|Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients|||Participants|||Number
2818870|NCT00391846|Secondary|Discontinuations|Number of patients discontinued due to adverse events'|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Participants|||Number
2818871|NCT00391846|Secondary|Total Number of Titration Steps in Prescribed Heart Failure Treatment|Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Titration steps|||Number
2818872|NCT00391846|Secondary|Changes in Health-related Quality of Life|Change range -100 to 100. The higher the better.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||KCCQ overall score||Standard Error|Mean
2818873|NCT00391846|Secondary|Changes in NT-proBNP Values Over Time in All Patients|The 95% confidential interval (CI) is given as measure of dispersion|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||ng/L||95% Confidence Interval|Geometric Mean
2818874|NCT00391846|Secondary|Changes in Heart Failure Symptoms|Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Categorial scale||Standard Deviation|Mean
2818875|NCT00391846|Secondary|Number of Days in Hospital for CV Reason|Each overnight stay is counted as one day. The lower the better|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Days in hospital||Standard Deviation|Mean
2818876|NCT00391846|Secondary|Number of CV Deaths|Number of deaths|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Participants|||Number
2818877|NCT00391846|Primary|Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)|The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.|||Scores on a scale||Standard Deviation|Mean
2818878|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population|||Percentage of Participants|||Number
2818879|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Percentage of Participants|||Number
2818880|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Percentage of Participants|||Number
2818881|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population|||Days||Standard Deviation|Mean
2818882|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Days||Standard Deviation|Mean
2818883|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Days||Standard Deviation|Mean
2818884|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population||12 cycles, 28 days each (336 days)|MITT Population|||Days||Standard Deviation|Median
2818885|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Days||Standard Deviation|Median
2818886|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Days||Standard Deviation|Median
2818887|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population|||Percentage of Participants|||Number
2818888|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population|||Percentage of Participants|||Number
2818889|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population|||Percentage of Participants|||Number
2818890|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population|MITT Population|13 cycles, 28 days each (1 year)|MITT Population|||Bleeding/Spotting Days||Standard Deviation|Mean
2818891|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population|MITT Population|6 cycles, 28 days each (168 days)|MITT Population|||Bleeding/Spotting Days||Standard Deviation|Mean
2818892|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population||13 Cycles, 28 days each (1 year)|MITT Population, All Subjects 18-45 years old, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population|||Pregnancy Rate|Participants||Number
2818893|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population|MITT Population|2 Cycles, 28 days each (56 days)|MITT Population|||Bleeding/Spotting Days||Standard Deviation|Mean
2818894|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,||13 cycles, 28 days each (1 year)|Modified Intent to Treat Population (MITT), Women Aged 18-35, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population|||Pregnancy Rate|Participants||Number
2818911|NCT00391625|Primary|Evaluation of Long Term Safety|Overall Summary of Treatment-emergent Adverse Events-Safety Population|Up to 84 months|ITT patient population|||Participants|||Number
2818912|NCT00391599|Primary|Number of Participants Had Spontaneous Feces|occurrence of spontaneous feces|On postoperative day 1||||participants|||Number
2818913|NCT00391599|Primary|Number of Participants With Gas Passage|gas passage: present|On postoperative day 1||||participants|||Number
2818895|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.|The Spearman coefficient and the p-values were computed between the clearance of viral RNA and oseltamivir carboxylate Area Under the Curve from 0 to 12 hours (AUC 0-12)|From date of enrollment until the date of first documented absence of viral load by culture, assessed up to 10 days after enrollment.|Subjects included in this analysis are those who had viral loads at baseline (day 0) and had a non-detectable viral load on one of the following study visit days: day 3, day 5, or day 10. Virus was obtained from a nasal swab. Subjects also would have had evaluable PK samples on study day 3.|||correlation measure|||Number
2818896|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort|The Spearman coefficient and the p-values were computed between the clearance of Viral RNA and Oseltamivir Carboxylate Area under the curve from 0 to 12 hours (AUC0-12)|Day to negative viral load for subjects positive at baseline|Subjects included in this analysis are those who had positive culture at baseline (day 0) and had a negative culture on one of the following study visit days: Day 3, Day 5 or Day 10. Culture was obtained from a a nasal swab. Subjects also would have had evaluable PK samples on study day 3.|||Spearman coefficient|||Number
2818897|NCT00391768|Secondary|Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)|Serious Adverse Event (SAE) were classified by MedDRA System Organ Class (SOC). An SAE was reported if it met the following criteria and occurred after the first dose of study medication through the end of the study: death throughout study participation; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; results in congenital anomaly or birth defect; results in a persistent or significant disability; and an event considered serious by the PI.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days||||Participants|||Number
2818898|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication|Study drug was administered for 5 days; any event that occurred prior to the last dose of study medication that was considered related to an AE and that caused the subject to stop taking study drug.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 day||||events|||Number
2818899|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade|Any event considered to be related to the study drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. The Division of AIDS Toxicity Tables (DIAIDS) were used to grade the events.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days|Intention to treat (ITT)|||Participants|||Number
2818900|NCT00391768|Secondary|Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.|Any neurological event that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)|||participants|||Number
2818901|NCT00391768|Secondary|Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.|Any event considered associated with drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)|||participants|||Number
2818902|NCT00391768|Primary|Oseltamivir Carboxylate AUC12 (Area Under the Curve).|The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.|Day 3 of drug administration|Subjects that received 3 days study drug administration and had successful PK draws on study day 3.|||participants|||Number
2818903|NCT00391716|Secondary|Craving|Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.|12-week||||units on a scale||Standard Error|Mean
2818904|NCT00391716|Secondary|Sleep|The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.|12-week||||units on a scale||Standard Error|Mean
2818905|NCT00391716|Secondary|Mood|Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.|12-week||||units on a scale||Standard Error|Mean
2818906|NCT00391716|Primary|Drinking|Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).|12-week|All randomized subjects included in denominator for rate determination.|||participants|||Number
2818907|NCT00391625|Secondary|Percent Change From Baseline in Spleen Size||Baseline, Month 24, then every 9 or 12 months|ITT (One patient was excluded due to an intravascular metallic device that prevented accurate spleen evaluation.)|||Percent Change from Baseline||Standard Error|Mean
2818908|NCT00391625|Secondary|Percent Change From Baseline in Liver Volume||Baseline, Month 24, then every 9 or 12 months|ITT|||Percent Change from Baseline||Standard Error|Mean
2818909|NCT00391625|Secondary|Percent Change From Baseline in Platelet Counts||Baseline, then every 12 months|ITT patient population|||Percent Change from Baseline||Standard Error|Mean
2818910|NCT00391625|Secondary|Percent Change From Baseline in Hemoglobin Concentration||Baseline, then every 12 months|Intent to treat (ITT) patient population|||Percent Change from Baseline||Standard Error|Mean
2818915|NCT00391586|Primary|Toxicity Profile|Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.|28 days after last on-study treatment||||participants|||Number
2818916|NCT00391586|Primary|Progression-free Survival (PFS)||5 years|This study was terminated early; no results are available. The number of patients who completed treatment and therefore the number of evaluable patients was too low to accurately calculate endpoints.||||||
2818917|NCT00391469|Secondary|Neurologic Status at Discharge-full Recovery||at time of discharge||||participants|||Number
2818918|NCT00391469|Primary|Number Alive at Hospital Discharge||at hospital discharge||||participants|||Number
2818919|NCT00391443|Secondary|Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|12 months|ITT population|||percentage of participants with event||95% Confidence Interval|Number
2818920|NCT00391443|Primary|Time to Occurrence of Disease Worsening or Death up to End of Study.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|36 months|The primary analysis was performed on the Intent To Treat (ITT) population.|||participants with event|||Number
2818921|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds|Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.|||Participants|||Number
2818922|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.|Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.|||Participants|||Number
2818923|NCT00391391|Secondary|Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.|Day 28 post-vaccination|Seroconversion to vaccine antigens were determined in the per-protocol population|||Percentage of Participants|||Number
2818924|NCT00391391|Secondary|Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|"Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.~Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique."|Day 28 post-vaccination|Seroprotection to vaccine antigens were determined in the per-protocol population|||Percentage of Participants|||Number
2818925|NCT00391391|Secondary|Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 28 post-vaccination|4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population|||Percentage of Participants|||Number
2818926|NCT00391391|Primary|Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2818927|NCT00391365|Secondary|Bodily Pain Section of Short Form-36 (SF-36)|"Patient reported bodily pain data from the SF-36, a thirty-six item survey evolved from the RAND 36.~Number shows change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 bodily pain data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.|||units on a scale||Standard Error|Mean
2818928|NCT00391365|Secondary|Physical Function Section of Short Form-36 (SF-36)|"Patient reported physical function data from the SF-36, a thirty-six item survey evolved from the RAND 36.~Change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 physical function data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.|||units on a scale||Standard Error|Mean
2818929|NCT00391365|Primary|Musculoskeletal Functional Assessment (MFA)|"Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items.~Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.)"|Over the course of 3 years|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the MFA data collected from 99 arthrodesis subjects, and 165 arthroplasty subjects.|||units on a scale||Standard Error|Mean
2819212|NCT00389207|Secondary|Proportion of Patients Reporting Rash of Any Severity|Proportion of Patients reporting rash of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
2818930|NCT00391274|Post-Hoc|Number of Patients With Disease Progression|Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.|time of response to progressive disease (up to 12 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.|||participants|||Number
2818931|NCT00391274|Primary|Overall Survival|Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.|baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)|Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.|||months||95% Confidence Interval|Median
2818932|NCT00391274|Secondary|Pharmacology Toxicity|Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.|first dose of study drug up to 24 months|Patients who received at least one dose of study drug.|||participants|||Number
2818933|NCT00391274|Secondary|Duration of Response|"Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as Number of Patients with Disease Progression."|time of response to progressive disease (up to 24 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.|||months||95% Confidence Interval|Median
2818934|NCT00391274|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.|baseline to measured progressive disease (up to 24 months after study enrollment)|"Intent to treat population. Patient censored:~pemetrexed=25, docetaxel=39."|||months||95% Confidence Interval|Median
2818935|NCT00391274|Secondary|Overall Tumor Response|"Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria."|baseline to measured tumor response (up to 24 months after study enrollment)|Patients who received at least one dose of study drug and qualified for tumor response analysis (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease).|||participants|||Number
2818936|NCT00391222|Secondary|Time to Recurrence of a Mood Episode (Exploratory/Olanzapine)|Recurrence was defined as for the risperidone LAI and placebo arms (meeting any of 5 criteria). Since the study was designed to compare the efficacy of risperidone LAI versus placebo, this olanzapine analysis was exploratory in nature.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 1 patient in the olanzapine arm (discontinued the study due to non-compliance to the study medication).|||days||Standard Error|Mean
2818937|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)|The MADRS was assessed by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. The scale consists of 10 items that cover all of the core depressive symptoms. Each item is scored from 0 to 6 and a total score is calculated by adding the scores of all 10 items. For each individual item as well as for the total score, a higher score represents a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||units on a scale||Standard Error|Mean
2818938|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)|The 11-item YMRS was administered by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. A severity rating was assigned to each of the items, based on the patient's subjective report of his or her condition over the previous 7 days or since the last visit (whichever was shorter) and the clinician's behavioral observations during the interview, with emphasis on the latter. The total YMRS score included the score of all 11 items ranging from 0 to 60, a higher score indicating a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||units on a scale||Standard Error|Mean
2818939|NCT00391222|Secondary|Time to Early Study Discontinuation for Any Reason|The robustness of the primary outcome analysis was tested by means of a sensitivity analysis: patients who discontinued the study during Period III for any reason were analyzed as having a recurrence of a mood episode at the time of their study discontinuation. The same survival analysis method as for the primary outcome was applied.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
2818940|NCT00391222|Secondary|Time to Recurrence of a Depressive Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of a depressive episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
2818941|NCT00391222|Secondary|Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of an elevated mood episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
2818942|NCT00391222|Primary|Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)|Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) >12 or Montgomery-Åsberg Depression Rating Scale (MADRS) >12 combined with Clinical Global Impression - Severity (CGI-S) >=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).|||days||Standard Error|Mean
2818943|NCT00391092|Secondary|Change From Baseline for FACT-G and FACT-B|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.|||units on a scale||Standard Deviation|Mean
2818944|NCT00391092|Secondary|Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.|||units on a scale||Standard Deviation|Mean
2818945|NCT00391092|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population|||months||95% Confidence Interval|Median
2819213|NCT00389207|Secondary|Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities||week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
2818946|NCT00391092|Secondary|Duration of Response (DR)|DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population: only participants with a best OR of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
2818947|NCT00391092|Secondary|Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline|Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population; only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2818948|NCT00391092|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population|||months||95% Confidence Interval|Median
2818949|NCT00391092|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population|||months||95% Confidence Interval|Median
2818950|NCT00391079|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|14 weeks; Baseline to end of treatment (last 7 days)||||points on a scale||Standard Deviation|Mean
2818951|NCT00391079|Secondary|Change in Subject Global Impression of Change (SGIC)|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to multiple sclerosis since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At baseline subjects wrote a brief description of their pain caused by multiple sclerosis which was used at Week 14 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported."|Week 14|All subjects who completed the question were included in the analysis. Two subjects from the Sativex group and six subjects from the placebo group did not complete the question.|||percentage of subjects|||Number
2818952|NCT00391079|Secondary|Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|14 weeks: Baseline to end of treatment (last 7 days of treatment)|All subjects who completed the BPI-short form were included in the analysis. Four subjects from the sativex group and three subjects from the placebo group did not complete the form.|||Points on a scale||Standard Deviation|Mean
2818953|NCT00391079|Secondary|Change From Baseline to End of Treatment in Break-through Analgesia Usage|Use of break through medication was recorded daily during the 14 weeks of the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|14 weeks: baseline - end of treatment (last 7 days)||||tablets||Standard Deviation|Mean
2818954|NCT00391079|Secondary|Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|14 weeks: Baseline - End of treatment (Week 14)||||Points on a scale||Standard Deviation|Mean
2818955|NCT00391079|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening."|14 weeks: Baseline - end of treatment (last 7 days)||||participants|||Number
2818956|NCT00391079|Primary|Change in Mean Pain Due to MS NRS Score|"The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline."|14 weeks: Baseline - End of Treatment (last 7 days of treatment)|Change in mean daily NRS score|||units on a scale||Standard Deviation|Mean
2818957|NCT00391053|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination|The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.|Day 0 to Day 7 Post-vaccination|The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.|||Percentage of Participants|||Number
2818958|NCT00391053|Secondary|Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.|Day 0 and Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.|||Percentage of Participants|||Number
2818959|NCT00391053|Primary|Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).|Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.|||Percentage of Participants|||Number
2818960|NCT00391053|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.|Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.|Day 0 and Day 28 Post-vaccination|The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.|||Titers||95% Confidence Interval|Geometric Mean
2818961|NCT00391027|Secondary|Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects|Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.|Baseline, Week 26|||||||
2818962|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)|Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.|Baseline, Week 26|FAS; LOCF.|||pg/ml||Standard Deviation|Mean
2818963|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)|Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.|Baseline, Week 26|FAS; LOCF.|||ng/ml||Standard Deviation|Mean
2818964|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)|Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.|Baseline, Week 26|FAS; LOCF.|||pg/ml||Standard Deviation|Mean
2818965|NCT00391027|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)|Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.|Baseline, Week 26|FAS; LOCF.|||mg/dl||Standard Deviation|Mean
2818966|NCT00391027|Secondary|Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients|The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.|Baseline, Week 26|FAS; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively. Revised table rectifies a programming code error that was determined post-Clinical study report (CSR) approval.|||mg/dl||Standard Deviation|Mean
2818967|NCT00391027|Secondary|Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health|Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.|Week 26|||||||
2818968|NCT00391027|Secondary|Number of Subjects Discontinued Due to Insufficient Clinical Response|Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.|Week 26|Safety population: all subjects who received at least 1 dose of study medication.|||participants|||Number
2818969|NCT00391027|Secondary|Change From Baseline in Body Mass Index (BMI)|BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.|Baseline, Week 26|FAS; LOCF.|||kg/m2||Standard Deviation|Mean
2818970|NCT00391027|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as body weight at observation minus body weight at baseline.|Baseline, Week 26|FAS; LOCF.|||kilograms (kg)||Standard Deviation|Mean
2818971|NCT00391027|Secondary|Number of Events of Nocturnal Hypoglycemia|Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.|Week 26|FAS|||events|||Number
2818972|NCT00391027|Secondary|Number of Subjects With Hypoglycemic Events by Severity|Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.|Week 26|FAS|||participants|||Number
2818973|NCT00391027|Secondary|Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)|Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.|Baseline, Week 26|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.|||mg/dl||Standard Deviation|Mean
2818974|NCT00391027|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level|FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.|Baseline, Week 26|FAS; LOCF.|||mg/dl||Standard Deviation|Mean
2818975|NCT00391027|Secondary|Number of Subjects With HbA1c < 8.0 %|Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.|Week 26|FAS|||participants|||Number
2818976|NCT00391027|Secondary|Number of Subjects With HbA1c < 7.0 %|Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.|Week 26|FAS|||participants|||Number
2818977|NCT00391027|Secondary|Number of Subjects With HbA1c < 6.5 %|Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.|Week 26|FAS|||participants|||Number
2818978|NCT00391027|Secondary|Change From Baseline in HbA1c Prior to Week 26|Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.|||percent||Standard Deviation|Mean
2818979|NCT00391027|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.|Baseline, Week 26|Full analysis set (FAS) all randomized subjects with at least 1 dose of study medication, baseline and post-baseline HbA1c measurement. Last observation carried forward (LOCF).|||percent||Standard Deviation|Mean
2818980|NCT00390949|Secondary|HIV/AIDS Knowledge||3 years|||||||
2818981|NCT00390949|Secondary|Health-seeking Behaviour Change||3 years|||||||
2818982|NCT00390949|Secondary|Sexual Behaviour Change (Sexual Debut, Sexual Partner Change, Non-regular Partners, Unprotected Sex With Regular and Casual Partners)||3 years|||||||
2818983|NCT00390949|Secondary|Sexually Transmitted Infection Treatment Effectiveness (Self-reported Cessation of Symptoms)||1 year|||||||
2818984|NCT00390949|Secondary|Self-reported Urethral or Genital Discharge||1 year|||||||
2818985|NCT00390949|Secondary|Self-reported Genital Ulcers||1 year|||||||
2818986|NCT00390949|Primary|HIV Incidence at the Community Level|Number of new infections occurring per 100 person-years of follow-up|3 years|General population|||HIV infections per 100 person-years||95% Confidence Interval|Number
2818987|NCT00390910|Secondary|Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818988|NCT00390910|Secondary|Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off|Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2818989|NCT00390910|Secondary|Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres|The cut-off for the assay was ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818990|NCT00390910|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2818991|NCT00390910|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.|The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818992|NCT00390910|Secondary|Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2818993|NCT00390910|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off|The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818994|NCT00390910|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off|Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2818995|NCT00390910|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off|The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818996|NCT00390910|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off|The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818997|NCT00390910|Secondary|Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off|Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2818998|NCT00390910|Secondary|Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off|The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2818999|NCT00390910|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2819000|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off|The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2819001|NCT00390910|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2819002|NCT00390910|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off|The cut-off for the assay was ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2819057|NCT00390780|Secondary|Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet|The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour|14 days|ITT (all randomized patients who took at least 1 dose of study medication)|||hours||Full Range|Mean
2819003|NCT00390910|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2819004|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off|The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2819005|NCT00390910|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2819006|NCT00390910|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off|The cut-off for the assay was ≥ 8|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2819007|NCT00390910|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2819008|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off|The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the ATP cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2819009|NCT00390910|Secondary|Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off|The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).|One month after the 3rd vaccine dose (Month 5)|The analysis was performed on the According-To-Protocol (ATP) cohort of immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2819010|NCT00390910|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
2819011|NCT00390910|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.|Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
2819012|NCT00390910|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
2819234|NCT00389207|Secondary|Change in CD4+ Count From Baseline|Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit|||cells/mm^3||Standard Deviation|Mean
2819013|NCT00390910|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|"Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
2819014|NCT00390910|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed included pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/ spontaneously painful. Grade 3 swelling/ redness was defined as swelling/ redness greater than (>) 30 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity."|Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
2819015|NCT00390910|Primary|Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.|Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled-in.~The analysis was performed, as planned per protocol, according to 2 groups: Preterm (i.e. very and mild preterm infants “Pooled Group I + II”) and Full term group (i.e. “Synflorix™ + Infanrix™ Hexa Group III”)."|||Participants|||Count of Participants
2819016|NCT00390884|Other Pre-specified|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®|Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination|Days 0-7 Post-vaccination|The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
2819017|NCT00390884|Secondary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
2819018|NCT00390884|Primary|Percentage of Seroprotected Participants Post-vaccination With Fluzone®|Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2819019|NCT00390858|Secondary|Relative Change in Serum Ferritin Level|Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline of Core Study to Extension 18 months, up to 2.5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.|||percent change||Standard Deviation|Mean
2819020|NCT00390858|Secondary|Total Body Iron Elimination (TBIE) Rate (mg/kg/Day)|Total Iron Body Elimination (TBIE) Rate [mg/kg/Day] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results.|Baseline of Core Study to End of Extension Study, up to 5 years|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.|||mg/kg/Day||Standard Deviation|Mean
2819021|NCT00390858|Primary|Change in Liver Iron Concentration (LIC)|Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)|Baseline of Core Study to End of Extension Study, up to 5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.|||mg Fe/g dw||Standard Deviation|Mean
2819022|NCT00390858|Primary|Participants With Adverse Events by Primary System Organ Class (SOC)|Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.|4 year extension + core 1 year|The safety set comprising of all the 40 patients who received at least one dose of deferasirox during the core or extension study was used in all analyses.|||participants|||Number
2819053|NCT00390806|Primary|Overall Survival|Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|From the time of Randomization until the date of death due to any cause (up to 195 weeks)|Intent-to-Treat (ITT) Population: all randomized participants. Participants were analyzed by the treatment to which they were randomized, even if this differed from the treatment they actually received.|||months||95% Confidence Interval|Median
2819023|NCT00390806|Secondary|Number of Participants Who Died or Progressed|Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|mITT Population|||participants|||Number
2819024|NCT00390806|Secondary|Brain Symptoms|"Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3."|Baseline, Month 1, and Month 3|||||||
2819025|NCT00390806|Secondary|Lesion Assessment and Measurement|"Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled Number of participants with a complete response (CR) or a partial response (PR) (central nervous system [CNS]-radiologic)."|From the time of Randomization until the time of CR or PR (up to 75 weeks)|||||||
2819026|NCT00390806|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range|"The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant Decreased to Low and Increased to High during the on-therapy period."|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|"Modified ITT Population. Only those participants with available laboratory values (indicated by the n in the category titles) were analyzed. Different participants may have been analyzed for different parameters; therefore, the overall number of participants analyzed reflects everyone in the Modified ITT Population."|||participants|||Number
2819027|NCT00390806|Secondary|Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|Modified ITT Population: all randomized participants who received at least one dose of randomized therapy. Participants were analyzed by the actual treatment received, even if this differed from the treatment to which they were randomized.|||participants|||Number
2819028|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819029|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819030|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819031|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819032|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3|The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819033|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819034|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819035|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819036|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819037|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819038|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3|The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819039|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819054|NCT00390780|Secondary|Treatment Compliance|Number of patients who were 100% compliant with the treatment regimen|Initiation of treatment to Day 14|ITT (all randomized patients who took at least 1 dose of study medication)|||participants compliant|||Number
2825128|NCT00343564|Secondary|Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||ng/mL||Standard Deviation|Mean
2819040|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819041|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819042|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819043|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819044|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819051|NCT00390806|Secondary|Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)|The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the time of CR or PR (up to 75 weeks)|ITT Population|||participants|||Number
2819045|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3|The investigator (per Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.|||participants|||Number
2819046|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3|The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.|||participants|||Number
2819047|NCT00390806|Secondary|Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3|Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG).|Months 1 and 3|ITT Population. Only those participants who were assessed for the indicated sign and symptom at the indicated time point were analyzed.|||participants|||Number
2819048|NCT00390806|Secondary|Time to Progression (TTP) (All Sites of Disease-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
2819049|NCT00390806|Secondary|Time to Progression (TTP) (CNS-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population|||weeks||95% Confidence Interval|Median
2819050|NCT00390806|Secondary|Time to Response (TTR) (CNS-radiologic)|TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)|ITT Population. Only those participants with a CR, PR, or a missing response were assessed. TTR was analyzed with censoring for extended loss to follow-up to account for two or more missed response assessments before a TTR event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|||weeks||95% Confidence Interval|Median
2819052|NCT00390806|Secondary|Six-month Survival|Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|Month 6|ITT Population|||percentage of participants|||Number
2819055|NCT00390780|Secondary|Susceptibility of Candida Species by Microdilution Test|minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit|Initiation of treatment to Day 17 to 22|ITT (all randomized patients who took at least 1 dose of study medication), nonresponders (participants with progression to a higher visible lesion extent score or no reduction in oral lesion extent score at the test of cure [Day 17 to 22] visit)|||mcg/ml||Standard Deviation|Mean
2819058|NCT00390780|Secondary|General and Local Tolerability and Oral Discomfort|Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14.|14 days|Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication)|||participants|||Number
2819059|NCT00390780|Secondary|Oral Discomfort Using Visual Analog Scale (VAS)|Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort)|14 days|Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)|||units on a scale||Full Range|Mean
2819060|NCT00390780|Secondary|Relapse at the Late Post-Therapy Visit (Day 35-38)|"Number of patients represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., clinical success) on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a clinical success at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under Not Analyzed-ITT."|35 to 38 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819061|NCT00390780|Secondary|Mycological Cure at the Test of Cure Visit (Day 17-22)|"Mycological cure was defined as a patient who had no yeast isolated when oral specimens were cultured for fungi."|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819062|NCT00390780|Secondary|Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819063|NCT00390780|Secondary|Clinical Success at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819064|NCT00390780|Secondary|Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819065|NCT00390780|Secondary|Clinical Cure at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819078|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 6 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Error|Least Squares Mean
2819066|NCT00390780|Primary|Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)~Per Protocol (PP, all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"|||participants|||Number
2819067|NCT00390689|Secondary|Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period|Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
2819068|NCT00390689|Secondary|Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
2819069|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
2819070|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 52 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Deviation|Mean
2819071|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 52 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Deviation|Mean
2819072|NCT00390689|Secondary|IRLS Responder for Open-label Period|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 52|Full Analysis Set (FAS).|||Percentage of patients|||Number
2819073|NCT00390689|Secondary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).|Week 52 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Deviation|Mean
2819074|NCT00390689|Secondary|Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.||baseline to 6 weeks||||participants|||Number
2819075|NCT00390689|Secondary|Patient Global Impression (PGI) Responder|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 6|Full Analysis Set (FAS).|||Percentage of patients|||Number
2819076|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 6|Full Analysis Set (FAS).|||Percentage of patients|||Number
2819077|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 6 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Error|Least Squares Mean
2819080|NCT00390689|Primary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.|Week 6 - change from baseline|Full Analysis Set (FAS).|||Points on a scale||Standard Error|Least Squares Mean
2819081|NCT00390611|Secondary|Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib|Number of patients experiencing treatment-related adverse events|18 months||||participants|||Number
2819082|NCT00390611|Secondary|Overall Survival (OS)|Overall survival was measured from the date of study entry until the date of death|18 months||||months||95% Confidence Interval|Median
2819083|NCT00390611|Secondary|Overall Response Rate (ORR)|Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level.|18 months||||participants|||Number
2819084|NCT00390611|Primary|2-year Progression-free Survival|The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years||||percentage of participants|||Number
2819085|NCT00390572|Primary|Sleep Quality|Changes in overall sleep quality were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rating scale that yields a quantitative index of general sleep quality/disturbances. The PSQI is composed of 4 open-ended questions and 19 self-rated items (0-3 scale) assessing sleep quality and disturbances over a 1-month interval. The PSQI yields a global score of sleep quality ranging from 0 to 21. A score of <= 5 on the PSQI is considered normal sleep quality.|10 Months|Data from all participants were included in analyses.|||units on a scale||Standard Deviation|Mean
2819086|NCT00390572|Primary|Sleep Efficiency|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 Months after Baseline|Data from all participants was included.|||percentage of time in bed spent sleeping||Standard Deviation|Mean
2819087|NCT00390572|Secondary|Sleepiness|Changes in subjectively assessed daytime sleep propensity were measured using the Epworth Sleepiness Scale (ESS), a commonly employed in both sleep research and clinical applications. The ESS items inquire about the chance of dozing off in each 8 different situations. Responses are rated on a 4 point scale reflecting the respondents perceived likelihood of falling asleep. To quanitfy this outcome, the percentage of participants achieving normal sleep (less than 10 on ESS) was compared across arms at 10 months.|10 months||||percentage of participants|||Number
2819088|NCT00390572|Primary|Diary Sleep: Total Wake Time and Total Sleep Time|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 months||||minutes||Standard Deviation|Mean
2819089|NCT00390572|Primary|Provider Adherence to Sleep Specialist Recommendations|Provider outcomes included the provider's number of participant sleep lab referrals, referrals to other specialty clinics for evaluation/treatment participant sleep problems, and presence of newly initiated sleep-focused therapies for participants. Information about these outcomes was obtained via review of provider orders and information included in notes entered into the VA's computerized medical record system (CPRS). To quantify this outcome, the number of participants referred by providers for sleep-focused diagnostic tests and interventions was compared across arms.|10 months after baseline|Data was included for all participants.|||participants|||Number
2819090|NCT00390559|Primary|Subjective Effects|"The full scale name is the Urge to smoke visual analog scale (VAS). It measures self-reported urge to smoke. As with any VAS a word or phrase (in this case, Urge to Smoke is centered over a horizontal line anchored on the left by not at all and on the right by extremely. In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (not at all) and the maximum score was 100 (extremely)."|6 hours|"Those who completed all four arms of the crossover study."|||units on a scale||Standard Deviation|Mean
2819091|NCT00390546|Secondary|Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin|In relation to the study drugs|12 months||||participants|||Number
2819092|NCT00390546|Secondary|Number of Treated Patients Experiencing First SVT Recurrence|Infants treated with propranolol or digoxin|up to 110 days of treatment||||participants|||Number
2819093|NCT00390546|Primary|Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.||6 months or until study endpoints were reached||||percentage of participants|||Number
2819094|NCT00390468|Primary|8-week Freedom-From-Progression (FFP)|Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.|8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.|Analysis was per protocol; Of 18 participants, only 15 were evaluable for efficacy.|||participants|||Number
2819095|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-positive Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 positive disease were analyzed.|||percentage of participants||95% Confidence Interval|Number
2819096|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-negative Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 negative disease were analyzed.|||percentage of participants||95% Confidence Interval|Number
2819097|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-positive Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, whichever occurred first.|Up to 5 years|Participants who started protocol therapy and had HER2-positive disease were analyzed.|||months||95% Confidence Interval|Median
2819098|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-negative Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first.|Up to 5 years|Participants who began protocol therapy with HER-2 negative tumors were analyzed.|||months||95% Confidence Interval|Median
2819099|NCT00390455|Secondary|Overall Survival (OS)|Overall survival was measured as the interval from study entry until death, from any cause, or last contact.|Study entry to death or last follow-up, up to 5 years|4 participants who never started protocol therapy were excluded.|||months||95% Confidence Interval|Median
2819100|NCT00390455|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy and had measurable disease were evaluated.|||percentage of participants||95% Confidence Interval|Number
2819101|NCT00390455|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).|Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years|4 participants who never received protocol therapy were excluded.|||months||95% Confidence Interval|Median
2819102|NCT00390429|Secondary|Correlation of EGFR Polymorphisms With Treatment Response and Clinical Outcome||Completion of study|Data were not collected.||||||
2819103|NCT00390429|Secondary|Correlation of Phospho-EGFR With Increased p27 and Clinical Outcome||Completion of study|Data were not collected.||||||
2819104|NCT00390429|Secondary|Correlation of Basal Levels of p27 With Response Rate and Overall Survival||Completion of study (up to 36 months)|Data were not collected.||||||
2819105|NCT00390429|Secondary|Correlation of Baseline EGFR Levels With Clinical Outcome||Completion of study (up to 36 months)|Data were not collected.||||||
2819106|NCT00390429|Secondary|Prognostic Significance of Epithelial Growth Factor Receptor (EGFR) Expression||Completion of study (up to 36 months)|Data were not collected.||||||
2819107|NCT00390429|Secondary|Frequency and Severity of Toxicities (Phase II)|Treatment-related adverse events Grade ≥3 by NCI CTCAE 2.0.|Completion of study (up to 36 months)||||participants|||Number
2819108|NCT00390429|Secondary|Progression-free Survival (Phase II)||Completion of study (up to 65 months)||||months||Full Range|Median
2819109|NCT00390429|Secondary|Overall Survival (Phase II)||Up to 65 months||||months||Full Range|Median
2819110|NCT00390429|Secondary|Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])|Maximum tolerated dose (MTD) defined as the highest dose level at which no more than one patient experienced DLT when at least 6 patients were treated at that dose level and were assessable for toxicity, graded according to NCI CTCAE 2.0.|up to 36 months|"Phase I, arm A, MTD: erlotinib 600-1000 mg d 2, 9, and 16; and docetaxel 70 mg/m^2 d 1 on a 21-d cycle.~Phase I, arm B, MTD: erlotinib 150-300 mg d 2 and 16; and docetaxel 70 mg/m^2 d 1 on a 21-d cycle."|||mg|||Number
2819111|NCT00390429|Secondary|Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])||up to 36 months||||participants|||Number
2819112|NCT00390429|Primary|Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.|||Participants|||Count of Participants
2819113|NCT00390429|Primary|Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])||Up to 36 months||||Participants|||Count of Participants
2819114|NCT00390416|Primary|1-year Survival||1 year||||months||95% Confidence Interval|Median
2819116|NCT00390416|Primary|6 Month Progression Free Survival|as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).|6 months||||percentage of participants||95% Confidence Interval|Number
2819117|NCT00390364|Primary|Response Rate: The Total Number of Participants With Progression of Disease|"To determine response rate and time to tumor progression of patients with colorectal cancer and mutations in the PI3KCA gene who are treated with RAD001. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by CT (or MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.~The outcome measure will be the total number of subjects who show progression of disease."|1 month||||participants with progression of disease|||Number
2819118|NCT00390325|Secondary|Selected Polymorphisms of Genes Influencing Sorafenib Tosylate Metabolism and/or Resistance Genes That May Predict Response or Toxicity|Changes will be correlated with toxicity and clinical response to therapy.|Baseline|Due to low tumor cellularity in the samples obtained, such evaluation was not possible||||||
2819119|NCT00390325|Secondary|Number of Participants With Ret Proto-Oncogene (RET) Gene Defects in the Tumor|Percent of patients with RET mutations|Baseline||||Participants|||Count of Participants
2819120|NCT00390325|Secondary|Number of Patients With Toxicity, Graded Using the Revised National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0|Toxicities were graded for patients using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 4 weeks after last dose of sorafenib tosylate||||Participants|||Count of Participants
2819121|NCT00390325|Secondary|Standardized Uptake Value (SUV Max) as Measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET)|Identify the median SUV at baseline and 8 week follow up as measured by Fludeoxyglucose F-18 Positron Emission Tomography (PET).|Up to 4 weeks after last dose of sorafenib tosylate||||maximum SUV||Full Range|Median
2819122|NCT00390325|Secondary|Degree of Vascular Endothelial Growth Factor (VEGF) Expression in the Tumor|Correlated with clinical response.|Up to 4 weeks after last dose of sorafenib tosylate|No data available||||||
2819123|NCT00390325|Secondary|Degree of Ras-MAPK Signaling Inhibition in the Tumor|Identify the number of patients with degree of Ras-MAPK signaling inhibition|Up to 4 weeks after last dose of sorafenib tosylate|Due to low tumor cellularity in the samples obtained, such evaluation was not possible||||||
2819124|NCT00390325|Secondary|Percent of Baseline Dynamic-Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Exchange Rate Constant (Kep)|Median decrease in exchange rate Kep in index lesions|Up to 4 weeks after last dose of sorafenib tosylate|kep [exchange rate constant]|||percentage change||Full Range|Median
2819125|NCT00390325|Secondary|Patient With Decreased Carcinoembryonic Antigen (CEA) Levels|Identify the number of patients with decreased Carcinoembryonic Antigen (CEA) levels|Up to 4 weeks after last dose of sorafenib tosylate|1 patient was not evaluable in Arm B|||Participants|||Count of Participants
2819126|NCT00390325|Secondary|Number of Patients With Decreased Calcitonin Levels|Identifying the number of patients with decreased calcitonin levels|Up to 4 weeks after last dose of sorafenib tosylate|1 patient was not evaluable in Arm B|||Participants|||Count of Participants
2819127|NCT00390325|Primary|Objective Response Rate of Sorafenib Tosylate in Metastatic Medullary Thyroid Carcinoma in Setting of Inherited Tumor Syndromes as Well as in Setting of Sporadic Medullary Thyroid Cancer|Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.|Up to 4 weeks after last dose of sorafenib tosylate|1 patient was not evaluable for RECIST evaluation in Arm B|||Participants|||Count of Participants
2819128|NCT00390299|Other Pre-specified|Viral Propagation in Tumor|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Up to day 5|||||||
2819129|NCT00390299|Other Pre-specified|Measles Virus Specific Immunity, in Terms of Change in Lymphoproliferative Assay Results|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to day 28|||||||
2819130|NCT00390299|Other Pre-specified|Measles Virus Specific Immunity, in Terms of Change in Interferon Gamma|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to day 28|||||||
2819131|NCT00390299|Other Pre-specified|Change in Viremia|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to up to 15 years|||||||
2819132|NCT00390299|Other Pre-specified|Change in Viral Shedding|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to day 28|||||||
2819133|NCT00390299|Other Pre-specified|Change in CD8 Counts|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to day 28|||||||
2819134|NCT00390299|Other Pre-specified|Change in CD46 Status|Descriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlates between these laboratory values and other outcome measures like response and dose levels will be carried out in an exploratory manner.|Baseline to up to day 5|||||||
2819137|NCT00390299|Secondary|Survival|Overall survival is defined as the length of time from date of registration to a) death due to any cause or b) last follow-up. Reported using standard Kaplan-Meier estimation method.|Up to 13 years|Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).|||months||95% Confidence Interval|Median
2819138|NCT00390299|Secondary|Progression-free Survival (PFS)|Percentage of patients who are progression free at 3 and 6 months (PFS3 and PFS6) will be summarized descriptively. Progression-free survival is defined as the length of time from date of registration to a) date of progression or death due to any cause or b) last follow-up. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions, and/or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.|Length of time from date of registration to a) date of progression or death due to any cause or b) last follow-up, assessed up to 6 months|Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).|||percentage of patients||95% Confidence Interval|Number
2819139|NCT00390299|Secondary|Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence|The number of responses will be summarized by simple descriptive summary statistics delineating response type. CR = total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. PR= 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. REGR = unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. SD = failure to qualify for CR, PR, REGR, or PROG. PROG = >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions and/or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions.|Up to 2 weeks|Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).|||Participants|||Count of Participants
2819140|NCT00390299|Primary|Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0|The number of patients experiencing grade 3+ adverse events (overall and by arm) will be tabulated and summarized in this patient population.|Up to 2 weeks|Per protocol analysis population; excludes cancel patient (never started treatment). Per section 16.2 of the protocol, this analysis will be performed by arm (for Arms A and B).|||Participants|||Count of Participants
2819141|NCT00390299|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include hematologic events grade 3 or higher (except grade 3 ANC lasting < 72 hours), non-hematologic events graded 3 or higher (except grade 3 nausea, vomiting, or diarrhea were to be considered DLT only if patient was receiving the max supportive care and alopecia was not considered dose limiting), neurologic toxicity grade 2 or higher, grade 2 allergic reactions asymptomatic bronchospasm and/or urticarial, grade 3 or higher allergic reactions, viremia lasting for 6 weeks or more from last viral administration deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event are reported.|2 weeks|Excludes cancel patient (never started treatment).|||patients|||Number
2819142|NCT00390234|Secondary|Survival (Carcinosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years||||months||95% Confidence Interval|Median
2819143|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)||6 months||||months||95% Confidence Interval|Median
2819144|NCT00390234|Secondary|Survival (Leiomyosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years||||months||95% Confidence Interval|Median
2819145|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)||6 months||||months||95% Confidence Interval|Median
2819146|NCT00390234|Primary|Objective Response Rate, Evaluated According to the RECIST Criteria||Up to 3 years||||participants|||Number
2819147|NCT00390221|Secondary|Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52|The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.|Baseline and Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing).|||units on a scale||Standard Deviation|Mean
2819148|NCT00390221|Secondary|Proportion of Participants Who Relapsed at Week 52|Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrawal from study were censored.|||proportion of participants|||Number
2819149|NCT00390221|Secondary|Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing) with a non-missing value at baseline.|||lesions||95% Confidence Interval|Mean
2819150|NCT00390221|Secondary|Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24|Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.|Week 8 through Week 24|Magnetic Resonance Imaging (MRI) Intensive Population: a protocol-defined subset of participants consisting of the first 307 participants enrolled in the study with non-missing baseline values.|||lesions||95% Confidence Interval|Mean
2819151|NCT00390221|Primary|Adjusted Annualized Relapse Rate Between Baseline and Week 52|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.|Baseline through Week 52|Intent to treat population: all randomized participants who received at least 1 dose of study medication (excluding 21 participants from a single site due to a protocol violation in dosing).|||relapses per person-years||95% Confidence Interval|Number
2819152|NCT00390182|Other Pre-specified|Time of Advanced/Recurrent Disease Without Distant Metastases.|Locally advanced/recurrent disease without distant metastases.|Participants were followed for an average of 8 years||||months||95% Confidence Interval|Median
2819153|NCT00390182|Other Pre-specified|Percentage of Participants With Distant Mestastases - Liver|Patients with distant mestastases to the liver|Participants were followed for an average of 8 years||||percentage of participants||95% Confidence Interval|Number
2819154|NCT00390182|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 weeks||||participants|||Number
2819155|NCT00390013|Primary|Change From Baseline in Vulvar Pain|change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.|19 weeks|study terminated early due to poor recruitment|||units on a scale||Full Range|Mean
2819156|NCT00389974|Primary|Objective Response Rate (PR or CR)|It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.|Up to 2 years|All patients evaluable for response|||percentage of evalubale patients||95% Confidence Interval|Number
2819157|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.|"Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).~Note: Influenza vaccine-primed group did not receive vaccination 2"|0 to 3 days post-vaccination 2|"Safety analysis was on all enrolled and vaccinated participants, intend to treat population.~Influenza vaccine-primed group did not received vaccination 2"|||Participants|||Number
2819158|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.|Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).|0 to 3 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population|||Participants|||Number
2819159|NCT00389857|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination|"GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.~Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)"|14 days post-vaccination|Geometric mean titers were evaluated in the per-protocol population.|||Titer||95% Confidence Interval|Geometric Mean
2819160|NCT00389831|Primary|Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.|The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.|4 hours post-treatment period at each treatment day|Full Analysis Set|||PLM per hour||Standard Deviation|Mean
2819161|NCT00389831|Primary|Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo|Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.|4 hours post-treatment period at each treatment day|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2819162|NCT00389818|Secondary|Event-free Survival at 1 Year||1 year post-treatment|||||||
2819163|NCT00389818|Secondary|Mortality and Cause of Death||At any time through the third year after treatment discontinuation|||||||
2819235|NCT00389207|Secondary|Proportion of Patients With VL < 400 Copies/ml|VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit|||Proportion of patients|||Number
2819164|NCT00389818|Secondary|Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
2819165|NCT00389818|Secondary|Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue||Baseline, after cycles 4 and 6, 1 month after treatment discontinuation|||||||
2819166|NCT00389818|Secondary|Relationship Between MDR-1 Expression and Response to Treatment||Baseline|||||||
2819167|NCT00389818|Primary|Rate of Bacterial, Fungal, and Opportunistic Infections||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
2819168|NCT00389818|Primary|Median Survival Time||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
2819169|NCT00389818|Primary|Duration of Response||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||||||
2819170|NCT00389818|Primary|Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||proportion of patients||95% Confidence Interval|Number
2819171|NCT00389805|Secondary|Effect of Bortezomib on Over Expression of NF-kB, BCL-2, and BCL-xL (Phase II)|Tumor levels of BCL-2, BCL-xL and BAX will be assessed by immunohistochemistry (IHC).|Up to 36 months|The Phase II study was not conducted.||||||
2819172|NCT00389805|Secondary|Importance of Folate-associated Gene Expression and Response or Outcome (Phase II)|Overexpression of reduced folate carrier (RFC) protein is thought to contribute to decreased resistance to pemetrexed. Levels of expression will be studied by measuring mRNA transcripts using quantitative Reverse Transcriptase-Polymerase Chain Reaction in archival patient tumor specimens.|Up to 36 months|The Phase II study was not conducted.||||||
2819173|NCT00389805|Secondary|Analysis of Molecular Determinants in Tumor Samples (Phase II)|Expression of relevant molecular targets of the proteasome, which is inhibited by bortezomib.|Up to 36 months|The Phase II study was not conducted.||||||
2819174|NCT00389805|Secondary|Number of Participants With Toxicities (Phase II)|Each adverse event will be determined by using the NCI CTCAE, Version 3.0.|Up to 36 months|The Phase II study was not conducted.||||||
2819175|NCT00389805|Secondary|Number of Participants With Response to Therapy as Measured by RECIST (Phase I)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence.|Up to 36 months|All patients for whom response evaluation measurements were recorded at baseline and after 2 cycles.|||Participants|||Count of Participants
2819176|NCT00389805|Secondary|Maximum Tolerated Dose of Bortezomib in Combination With Pemetrexel (Phase I)||Up to 36 months||||Mg/m^2|||Number
2819177|NCT00389805|Secondary|Number of Patients With Toxicity by NCI CTC v3.0 (Phase I)|Adverse events possibly related to treatment, graded according to the NCI CTCAE v3.0.|Up to 36 months||||participants|||Number
2819178|NCT00389805|Primary|Number of Patients Who Responded to Study Treatment (Phase II)|To determine the response rate of bortezomib in combination with pemetrexed in patients with advanced NSCLC. Response rate was assessed by CT scan. CT scans was performed at baseline and every two cycles (prior to 3rd and 5th cycle). The evaluation of response was based on standard RECIST criteria.|From start of treatment until disease progression/recurrence.|The Phase II study was not conducted.||||||
2819179|NCT00389805|Primary|Number of Patients With Grade ≥ 3 Toxicity (Phase I)|Grade 3/4 toxicity occurring in a patient within 1 cycle.|First cycle of treatment (3 weeks)||||participants|||Number
2819180|NCT00389805|Primary|Number of Participants Who Experience Adverse Events (Phase I)|Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).|Throughout the entire study (up to 36 months).||||Participants|||Count of Participants
2819181|NCT00389805|Primary|Number of Patients Experiencing a Dose-limiting Toxicity (Phase I)|Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting >7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade >/=3 non-hematologic toxicity considered by the investigator to be related to study drug.|Up to 36 months||||Participants|||Count of Participants
2819182|NCT00389597|Primary|Composite Definition of Study Success|"An individual subject in either treatment group was considered a success if the following criteria were met at 24 months:~Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities.~No study failures due to secondary surgical interventions at the index level~Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC"|2 Years|includes study failures, per protocol, that are carried forward for overall success|||percentage of subjects analyzed|||Number
2819183|NCT00389532|Primary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination|GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.|21 days post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population|||Titer||95% Confidence Interval|Geometric Mean
2830050|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Firmness|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2819184|NCT00389532|Primary|Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination|Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)|0-3 days post-vaccination|Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.|||Percentage of Participants|||Number
2819185|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)|Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF|||mL/min per 1.73 m2||Standard Deviation|Mean
2819186|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Potassium|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF|||mg/dL||Standard Deviation|Mean
2819187|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Creatinine|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF|||mg/dL||Standard Deviation|Mean
2819188|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)|||mm Hg||Standard Deviation|Mean
2819189|NCT00389519|Primary|Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)|||mm Hg||Standard Deviation|Mean
2819190|NCT00389493|Secondary|Brown Assessment of Beliefs (BABS)|"Scale ranges from 0 to 24 where 0 is beliefs are false and 24 is convinced beliefs = reality"|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
2819191|NCT00389493|Secondary|Hamilton Depression Rating Scale (Ham-D)|Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
2819192|NCT00389493|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form|QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
2819193|NCT00389493|Secondary|Social Adjustment Scale-SR|SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
2819194|NCT00389493|Primary|Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity|Week 0 and Week 8||||units on a scale||Standard Deviation|Mean
2819195|NCT00389467|Secondary|Day 90 Mortality||at day 90||||participants|||Number
2819196|NCT00389467|Secondary|Symptomatic Hemorrhagic Transformation|"Symptomatic intracranial hemorrhage is defined as 4 point neurologic worsening on the National Institutes of Health Stroke Scale (NIHSS) score associated with parenchymal hematoma type 2 (PH-2*), remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage on imaging. The NIHSS is a scale measuring specific neurologic deficits caused by a stroke with scores ranging from 0 to 42, and higher scores indicating more severe neurologic deficits.~*from the modified European Cooperative Acute Stroke Study (ECASS) II criteria"|from baseline to day 7||||participants|||Number
2819197|NCT00389467|Primary|The Modified Rankin Scale Score|"Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death.~0 - No symptoms.~1 - No significant disability. Able to carry out all usual activities, despite some symptoms.~2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~3 - Moderate disability. Requires some help, but able to walk unassisted.~4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~6 - Dead."|at 90 days post-stroke||||units on a scale||95% Confidence Interval|Mean
2819198|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.|||units on a scale||Standard Deviation|Mean
2819214|NCT00389207|Secondary|Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144|Calculations based on the MDRD algorithm.|From baseline to Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||mL/min/1.73 m^2||Standard Deviation|Mean
2819215|NCT00389207|Secondary|Time to Treatment Failure|Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||weeks||Inter-Quartile Range|Median
2819199|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.|||units on a scale||Standard Deviation|Mean
2819200|NCT00389441|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline to death due to any cause or at least 2 year after the first dose for the last participant|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.|||weeks||95% Confidence Interval|Median
2819201|NCT00389441|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
2819202|NCT00389441|Secondary|Progression Free Survival (PFS)|PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.|||weeks||95% Confidence Interval|Median
2819203|NCT00389441|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2819204|NCT00389324|Primary|Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)|Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).|IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days|A total of 32 subjects in the IV phase and 26 subjects in the SC phase had sufficient plasma concentration of total IgG vs. time profiles (AUC) for assessment of steady-state PK parameters.|||mg*hr/ml||Standard Deviation|Least Squares Mean
2819205|NCT00389207|Secondary|Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144|Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||ratio||Standard Deviation|Mean
2819206|NCT00389207|Secondary|Change of Total Triglycerides From Baseline to Week 48, 96, 144|Change of total triglycerides from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||mg/dL||Standard Deviation|Mean
2819207|NCT00389207|Secondary|Change of hsCRP From Baseline to Week 48, 96, 144|Change of hsCRP from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||mg/L||Standard Deviation|Mean
2819208|NCT00389207|Secondary|Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144|Changes frombaseline apolipoprotein A1 & B|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||g/L||Standard Deviation|Mean
2819209|NCT00389207|Secondary|Change of Cholesterol Values From Baseline to Week 48, 96, 144|Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered|||mg/dL||Standard Deviation|Mean
2819210|NCT00389207|Secondary|Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity|Proportion of Patients reporting CNS (central nervous system) side effects of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
2819211|NCT00389207|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity|Proportion of Patients reporting hepatic events of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
2819216|NCT00389207|Secondary|Time to Loss of Virologic Response (Rebound)|Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.|Baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||weeks||Inter-Quartile Range|Median
2819217|NCT00389207|Secondary|Time to Treatment Response (First Confirmed VL<50 Copies/mL)|Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||weeks||Inter-Quartile Range|Median
2819218|NCT00389207|Secondary|Proportion of Patients With Virologic Failure at Week 48, 96, 144||at Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||participants|||Number
2819219|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
2819220|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.|||participants|||Number
2819221|NCT00389207|Secondary|Treatment Response at Week 144|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.|From baseline to Week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories.|||participants|||Number
2819222|NCT00389207|Secondary|Treatment Response at Week 96|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.|From baseline to Week 96|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||participants|||Number
2819223|NCT00389207|Secondary|Glycaemic Abnormalities|Number of patients with AE elevated serum glucose|From baseline to Week 144|FAS|||Patients|||Number
2819224|NCT00389207|Secondary|Serum Lipid Abnormalities|Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)|From baseline to Week 144|FAS|||patients|||Number
2819225|NCT00389207|Secondary|Lipodystrophy|Number of patients with AE lipodystrophy|From baseline to Week 144|FAS|||Patients|||Number
2819226|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness Leading to Death|Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.|From baseline to Week 144|FAS|||Patients|||Number
2819227|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness|Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment|From baseline to Week 144|FAS|||Patients|||Number
2819228|NCT00389207|Secondary|Genotypic Resistance Associated With Virologic Failure|Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.|From baseline to Week 48|All patients with virologic failure assessed for genotypic resistance|||Number of substitutions|||Number
2819229|NCT00389207|Secondary|Non-scheduled Physician Visits|Cost effectiveness assessment by number of patients with non-scheduled physician visits|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing|||patients|||Number
2819230|NCT00389207|Secondary|Number of Patients Hospitalized|Cost effectiveness assessment by number of patients hospitalized|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing|||Patients|||Number
2819231|NCT00389207|Secondary|Change in Physical Health Summary (PHS) Score From Baseline|QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing|||Units on a scale||Standard Deviation|Mean
2819232|NCT00389207|Secondary|Change in Mental Health Summary (MHS) Score From Baseline|Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing|||Units on a scale||Standard Deviation|Mean
2819233|NCT00389207|Secondary|Change in Framingham Score From Baseline|Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing|||Units on a scale||Standard Deviation|Mean
2820303|NCT00381849|Primary|24 Hour Urinary Cystine Excretion||baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Cystine excretion was not applicable to the Calcium Stone subjects.|||mcmol/24 hours||Standard Deviation|Mean
2819236|NCT00389207|Secondary|Proportion of Patients With VL < 50 Copies/ml|VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit|||Proportion of patients|||Number
2819237|NCT00389207|Secondary|Treatment Response at Week 48 (TLOVR Algorithm)|Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.|From baseline to Week 48|FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories|||Patients|||Number
2819238|NCT00389207|Primary|Treatment Response at Week 48|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.|From baseline to Week 48|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories|||Patients|||Number
2819239|NCT00389168|Secondary|Effects on Carotid Artery Wall Thickness|Changes in common carotid artery intima-media thickness, assessed by ultrasonography.|Baseline to 48 weeks||||mm||Standard Deviation|Mean
2819240|NCT00389168|Secondary|Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System|Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.|Baseline to 48 weeks||||pmol/L||95% Confidence Interval|Mean
2819241|NCT00389168|Secondary|Blood Pressure|Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks|Baseline to 48 weeks||||mm Hg||95% Confidence Interval|Mean
2819242|NCT00389168|Secondary|Left Ventricular Diastolic Function Assessed by the E/A Ratio|Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.|Baseline to 48 weeks||||ratio||Standard Deviation|Mean
2819243|NCT00389168|Primary|Changes in Left Ventricular Mass Index|Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).|Baseline and 48 weeks|Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants.|||g/m^2||95% Confidence Interval|Mean
2819244|NCT00389168|Secondary|Number of Participants With Serious Adverse Events|Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.|Treatment period was baseline to 48 weeks||||Participants|||Number
2819245|NCT00389064|Secondary|Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)|Number of patients have adverse events associated with EPS|From start of the study teatment to last dose plus 30 days|Safety population|||Patients|||Number
2819246|NCT00389064|Secondary|Safety and Well Tolerated as Measured in Adverse Event|Number of patients have at least one adverse event|From the start of treatment to last dose plus 30 days|Safety population|||Participants|||Number
2819247|NCT00389064|Secondary|Change in the Visual Analogue Scale (VAS) Measuring Pain|Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.|||mm||Standard Deviation|Least Squares Mean
2819248|NCT00389064|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
2819249|NCT00389064|Secondary|Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission|"HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:~If HAM-A total score≤7, THEN indicator=1~If HAM-A total score >7, THEN indicator=0"|Week 9|Modified Intent to Treat (MITT) population.|||Number of participants.|||Number
2819250|NCT00389064|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Response.|HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.|Week 9||||Number of participants.|||Number
2819251|NCT00389064|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
2819252|NCT00389064|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
2819253|NCT00389064|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
2819254|NCT00389064|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 9 minus percentage at randomization"|Randomization to Week 9|In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo).|||Percentage of Maximum Total Score||Standard Deviation|Least Squares Mean
2819255|NCT00389064|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.|||units on scale||Standard Deviation|Least Squares Mean
2819256|NCT00388973|Secondary|Tolerability as Measured by Adverse Event Withdrawals During Treatment||Baseline to Week 9|All Randomized patients.|||Participants|||Number
2819257|NCT00388973|Secondary|Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)|The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Full Range|Median
2819258|NCT00388973|Secondary|Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10|The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Full Range|Median
2819259|NCT00388973|Secondary|Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Standard Deviation|Least Squares Mean
2819260|NCT00388973|Secondary|Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)|Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on a scale||Standard Deviation|Least Squares Mean
2819261|NCT00388973|Secondary|Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)|Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. Patients not on medication at baseline would have left the item blank and therefore no change from baseline could be calculated|||units on scale||Full Range|Median
2819262|NCT00388973|Secondary|Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)|Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||Percentage of Improvement||Standard Deviation|Least Squares Mean
2819263|NCT00388973|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.|MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.|||units on scale||Standard Deviation|Least Squares Mean
2819264|NCT00388947|Secondary|Prolapse Efficacy Success Rate|Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.|24 months|Patients returning for a visit between 19-24 months post-procedure.|||percentage of participants||95% Confidence Interval|Number
2819265|NCT00388947|Primary|Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device||up to 2-years post-implant|All patients that met the inclusion/exclusion criteria.|||participants|||Number
2819266|NCT00388804|Primary|Prostate Specific Antigen (PSA) Failures|Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.|3 months up to 2 years|One person was not treated and therefore excluded from the analysis.|||participants|||Number
2819267|NCT00388726|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||From start of study drug administration up to 30 days after the last dose of study drug (approximately up to 42 months)|The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.|||participants|||Number
2819268|NCT00388726|Secondary|Duration of Response.|As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.|From first documented CR or PR until disease progression or death.|Response Evaluable Population|||Days||Full Range|Median
2820525|NCT00380250|Secondary|Month 3 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819269|NCT00388726|Secondary|Best Overall Response|Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.|Response Evaluable Population|||Percent of Participants|||Number
2819270|NCT00388726|Secondary|Progression-Free Survival.|Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.|Until disease progression or death.|Intent to Treat|||Days||Full Range|Median
2819271|NCT00388726|Primary|Overall Survival|Defined as the time from the date of randomization until the date of death from any cause.|From date of randomization until death from any cause|Intent to Treat|||Days||Full Range|Median
2819272|NCT00388674|Secondary|Number of Participants With Liver-related Death|The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
2819273|NCT00388674|Secondary|Number of Participants With HCC Malignant Neoplasm|The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
2819274|NCT00388674|Secondary|Number of Participants With Non-HCC Malignant Neoplasm|The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
2819275|NCT00388674|Primary|Number of Participants With Liver-related HBV Disease Progression|The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
2819276|NCT00388674|Primary|Number of Deaths|The number of deaths, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
2819277|NCT00388674|Primary|Number of Participants With Adjudicated Overall Malignant Neoplasms|The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)|10 years|All randomized, treated participants|||Participants|||Number
2819278|NCT00388583|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus.~Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia."|Day 0 up to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
2819279|NCT00388583|Primary|Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40|Day 28 post-vaccination|Immunogenicity determination was in all per protocol population|||Participants|||Number
2819280|NCT00388583|Secondary|Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.|The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre- and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2819281|NCT00388583|Primary|Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre-vaccination and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population|||Participants|||Number
2819282|NCT00388505|Secondary|Hospitalization Due to Respiratory Events During the Study|The average number of days patients were hospitalized due to respiratory events during the course of the study.|25 Weeks|Patients in the intent-to-treat population who were hospitalized due to respiratory events.|||days||Standard Deviation|Mean
2819283|NCT00388505|Secondary|Antipseudomonal Antibiotic Usage During the Study|The average number of days patients required antipseudomonal antibiotics during the course of the study.|25 Weeks|Patients in the intent-to-treat population who required antipseudomonal antibiotics.|||days||Standard Deviation|Mean
2819284|NCT00388505|Secondary|Change From Baseline in Tobramycin Minimum Inhibitory Concentration|The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.|||μg/mL||Standard Deviation|Mean
2819285|NCT00388505|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Three Pseudomonas aeruginosa biotypes were assessed in patient's sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.|||log10 Colony forming units/g||Standard Deviation|Mean
2819286|NCT00388505|Secondary|Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication|Patient's self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.|Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).|Intent-to-treat population for whom data were available.|||Scores on a scale||Standard Deviation|Mean
2819287|NCT00388505|Secondary|Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)|"Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.~Relative change = 100 * ((Day 28 of Cycle 3 value - Baseline value)/ Baseline value)."|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.|||percent of predicted||Standard Deviation|Mean
2819288|NCT00388505|Secondary|Percentage of Participants With a Decrease From Baseline in Auditory Acuity|Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)|Audiology subpopulation|||percentage of participants|||Number
2819289|NCT00388505|Secondary|Serum Tobramycin Concentrations|Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).|Weeks 1, 5, 17 and 21|Pharmacokinetic subpopulation|||μg/mL||Standard Deviation|Mean
2819290|NCT00388505|Primary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.|25 weeks|All Randomized Safety population.|||participants|||Number
2819291|NCT00388453|Secondary|Number of Reflux Events|Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours||||reflux events||Inter-Quartile Range|Median
2819292|NCT00388453|Primary|Decrease in pH From Baseline to <6|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|||distal esophagus total % time pH <6||Inter-Quartile Range|Median
2819293|NCT00388453|Primary|Decrease in pH From Baseline to <5|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals.|||distal esophagus total % time pH <5||Inter-Quartile Range|Median
2819294|NCT00388453|Primary|Decrease in pH From Baseline to <4|The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.|24 hours|Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.|||distal esophagus total % time pH <4||Inter-Quartile Range|Median
2819295|NCT00388414|Primary|Neural Correlates of Pain Relief|"Scores reflect the average connectivity strength of that region of interest to the rest of the cortex.~There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3).~Subscales are averaged."|3 months||||Units on a scale||Standard Deviation|Mean
2819296|NCT00388414|Primary|Pain|"Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study.~Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine.~Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline.~Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100."|3 months||||Percentage change from baseline to end||Standard Deviation|Mean
2819297|NCT00388362|Secondary|Overall Survival|Administration of Sirolimus and Prednisone|3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus|23 patients that remained on the study for a median of 514 days (96-814 days), 2 died (1- second cancer and 1- progressive cardiac failure)|||participants|||Number
2820526|NCT00380250|Secondary|Month 2 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819298|NCT00388362|Primary|Clinical Activity|Determined by discontinuation of immunosuppression with resolution of all reversible CGVHD manifestations. Evaluated at 2 years after enrollment|3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus|23 patients that remained on the study for a median of 514 days (96-814 days). Numbers based on resolution/ improvement in clinical manifestations of cGVHD with a median of 90% reduction in prednisone dose and no additional immunosuppressive therapy over a two year treatment period.|||participants|||Number
2819299|NCT00388349|Secondary|Survival Measures|"Reports the survival measures:~Freedom from progression (FFP)~Event-free survival (EFS)~Overall survival (OS)~EFS and OS were estimated by Kaplan-Meier method~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|2 years|Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected|||percentage of patients||95% Confidence Interval|Number
2819300|NCT00388349|Secondary|Relapse Post-transplant|Reports the percentage of participants that experienced relapse post-transplant.|2 years|All participants|||percentage of participants|||Number
2819301|NCT00388349|Secondary|Overall Survival (OS)|Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).|2 years|All participants|||percentage of participants|||Number
2819302|NCT00388349|Secondary|Pulmonary Toxicity (BCNU Pneumonitis)|Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).|2 years|Patients who completed the study regardless of gemcitabine dose, and had all data points collected.|||participants|||Number
2819303|NCT00388349|Primary|Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity|Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.|6 months|7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study|||participants|||Number
2819304|NCT00388297|Secondary|Number of Days in the Hospital Nursery|Median number of days in the hospital nursery|Through hospital discharge||||days||95% Confidence Interval|Median
2819305|NCT00388297|Secondary|Number of Infants With Respiratory Therapy Greater Than or Equal to 1 Day|oxygen therapy (FiO2 ≥ 0.40) for greater than or equal to 24 hours|72 hours post delivery||||Participants|||Count of Participants
2819306|NCT00388297|Secondary|Number of Infants With Bronchopulmonary Dysplasia|Bronchopulmonary dysplasia (BPD) is defined as the need for supplemental oxygen at 36 weeks corrected age, for babies born <34 weeks by project gestational age only|Through 72 hours post delivery||||Participants|||Count of Participants
2819307|NCT00388297|Secondary|Number of Infants With Necrotizing Enterocolitis|Necrotizing enterocolitis (NEC) is defined by the following: the unequivocal presence of intramural air on abdominal x-ray, perforation seen on abdominal x-ray, clinical evidence as suggested by erythema and induration of the abdominal wall, or intra-abdominal abscess formation, or stricture formation observed at surgery or autopsy following an episode of suspected NEC. The condition is classified based on the Bell staging system|Delivery within 2 weeks of birth||||Participants|||Count of Participants
2819308|NCT00388297|Secondary|Number of Infants With Retinopathy or Prematurity|This diagnosis will be reached when an ophthalmologic examination of the retina has been performed and ROP is diagnosed at Stage I (demarcation line in the retina) or greater|Through 72 hours of birth||||Participants|||Count of Participants
2819309|NCT00388297|Secondary|Number of Infants With Respiratory Distress Syndrome|Respiratory distress syndrome (RDS) will be defined based on a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 ≥ 0.40) for greater than or equal to 24 hours. For infants dying before 24 hours of age, a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 ≥ 0.40) are sufficient.|Delivery and greater than or equal to 24 hours||||Participants|||Count of Participants
2819310|NCT00388297|Secondary|Neonatal Head Circumference (Centimeters)|Neonatal head circumference measured within 24 hours of birth. This measurement is included based on a report showing that maternal treatment with thyroxine for overt hypothyroidism was associated with reduced head circumference in the newborn infant|Within 24 hours of birth||||centimeters||Standard Deviation|Mean
2819311|NCT00388297|Secondary|Infants With Birth Weight < 10th Percentile (Gestational Age z Score)|Birth weight < 10th percentile (gestational age z score)|Delivery||||Participants|||Count of Participants
2819312|NCT00388297|Secondary|Number of Infants Admitted to NICU|Admission to NICU|Delivery||||Participants|||Count of Participants
2819313|NCT00388297|Secondary|Number of Infants With Apgar Score 4 at 1 Minute and < 7 at 5 Minutes|Apgar score < 4 at 1 minute and < 7 at 5 minutes|1 minute and 5 minutes post delivery||||Participants|||Count of Participants
2819314|NCT00388297|Secondary|Number of Neonatal Deaths|Fetal and neonatal death|Through 72 hours post delivery||||Participants|||Count of Participants
2819315|NCT00388297|Secondary|Participants Who Experienced a Stillbirth or Miscarriage|Stillbirth or miscarriage.|Delivery||||Participants|||Count of Participants
2819316|NCT00388297|Secondary|Participants With Composite Neonatal Outcome|The composite neonatal outcome was defined as periventricular leukomalacia, intraventricular hemorrhage of grade III or IV, necrotizing enterocolitis (stage ≥II), severe retinopathy of prematurity (stage ≥III), the severe respiratory distress syndrome, bronchopulmonary dysplasia, neonatal death, stillbirth, or serious infectious complication.|Within 72 hours of delivery.||||Participants|||Count of Participants
2819317|NCT00388297|Secondary|Gestational Diabetes Mellitus|A patient is considered to have gestational diabetes if clinically diagnosed with class A1 or A2|During pregnancy until delivery||||Participants|||Count of Participants
2819318|NCT00388297|Secondary|Participants With Preeclampsia|Preeclampsia defined as patient having a diastolic ≥ 90 during pregnancy with at least 1 + proteinuria. Preeclampsia will also include HELLP syndrome or eclampsia.|Duration of pregnancy, Delivery||||Participants|||Count of Participants
2819319|NCT00388297|Secondary|Participants With Gestational Hypertension|Gestational hypertension defined as patient having a diastolic ≥ 90 during pregnancy without proteinuria|During pregnancy and until delivery||||Participants|||Count of Participants
2819320|NCT00388297|Secondary|Participants With Placental Abruption|Clinically significant placental abruption will be determined by centralized (blinded) chart review|Duration of pregnancy, delivery||||Participants|||Count of Participants
2819321|NCT00388297|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Index Score From the Connors' Rating Scales (Parent-S) - Revised|The Conners' Rating Scales-Revised were used to assess attention deficit-hyperactivity disorder (ADHD). A T score of 45 to 55 is considered to be typical or average; a T score of 44 or less is not a concern, a T score of 56 to 60 is considered to be a borderline score, and a T score of 61 or higher indicates a possible or clinically significant problem.|48 months of age||||T-score||95% Confidence Interval|Median
2819322|NCT00388297|Secondary|Behavioral Problems and Social Competencies at 36 and 60 Months of Age, as Measured by the Child Behavior Checklist (CBCL)|Behavioral problems and social competencies at 36 and 60 months of age, as measured by the Child Behavior Checklist (CBCL). The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. A Tscore of less than 60 is considered to be in the normal range. A T score of 60-63 is a borderline, and a T score of more than 63 is in the clinical range. Lower scores represent better outcomes.|36 and 60 months of age|The potential follow-up cohort consisted of 335 children in the levothyroxine group and 329 in the placebo group for subclinical hypothyroidism and for hypothyroxinemia - 260 children in the levothyroxine group and 255 in the placebo group. A Child Behavior Checklist T score of less than 60 is considered to be in the normal range.|||T-score||95% Confidence Interval|Median
2819323|NCT00388297|Secondary|Cognitive, Motor and Language Scale Scores From the Bayley Certified Scales of Infant Development III Edition|Composite scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Results can also be expressed as percentile ranks relative to the standardization sample, with a mean and median of 50 and range from 1 to 99|12 and 24 months of age|For all outcomes except the primary outcome the potential follow-up cohort in the subclinical hypothyroidism groups consisted of 335 children in the levothyroxine group and 329 in the placebo group, and for the hypothyroxinema groups: 254 children in the levothryoxine group and 253 children in the placebo group.|||score on a scale||95% Confidence Interval|Median
2819324|NCT00388297|Secondary|Cognitive and Achievement Levels From Two DAS-II Subtests (Recall of Digits Forward and Recognition of Pictures)|"Cognitive and achievement levels from two DAS-II subtests (Recall of Digits Forward and Recognition of Pictures)~GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low~≤ 69 Very low"|48 months of age|For all outcomes except the primary outcome, the potential follow-up cohort consisted of 335 children in the levothyroxine group and 329 in the placebo group for the mothers with subclinical hypothyroidism and for the hypothyroxinemia group - 260 children in the levothyroxine group and 255 children in the placebo group.|||score on a scale||95% Confidence Interval|Median
2819325|NCT00388297|Secondary|Cognitive and Achievement Levels From the Differential Ability Scales (DAS II)|"Overall general conceptual ability score as measured by the DAS-II at 36 months of age.~GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low~≤ 69 Very low"|36 months||||score on a scale||95% Confidence Interval|Median
2819326|NCT00388297|Secondary|Selected Cognitive Abilities From the Subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)|"Standardized full-scale IQ scores from the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3.~For Quotient and Composite score:~below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior."|60 months||||score on a scale||95% Confidence Interval|Median
2819327|NCT00388297|Secondary|Number of Participants With Preterm Delivery|Preterm delivery at less than 37 weeks or less than 34 weeks gestation|Delivery||||Participants|||Count of Participants
2819328|NCT00388297|Secondary|Week of Gestation at Delivery|Gestational age at delivery and preterm birth < 37 weeks' gestation or < 34 weeks' gestation|Delivery||||weeks||Standard Deviation|Mean
2819329|NCT00388297|Primary|Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death.|"The primary outcome was death or IQ score at 5 years of age (or at 3 years of age if the 5-year examination was missing). The full-scale IQ was assessed with the use of the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age or the overall (general conceptual ability) score from the Differential Ability Scales-II at 3 years of age if the WPPSI-III score was not available. Results are expressed as an age-standardized score, with an expected population mean of 100 and a standard deviation of 15. Death before 3 years of age was assigned a score of 0 (lowest possible rank) and was included in the estimation of the median.~For Quotient and Composite score:~below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+"|60 months of age||||score on a scale||95% Confidence Interval|Median
2819330|NCT00388154|Primary|Overall Objective Response Rate (CR + PR)|Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.|||percentage of participants|||Number
2819736|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Heart Rate|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||beats per minute||Standard Error|Least Squares Mean
2819331|NCT00388154|Primary|Participant Responses|Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.|||participants|||Number
2819332|NCT00388037|Primary|Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.|Up to 3 years|All response evaluable patients|||percentage of evalubale patients||95% Confidence Interval|Number
2819333|NCT00387959|Primary|Survival at 1 Year After Transplantation|The number of patients survival status 1 year after transplantation|1 Year after transplant||||participants|||Number
2819334|NCT00387894|Secondary|Duration of Progress-free Survival (PFS)|Patients with stable or responding disease will continue treatment until tumor progression is determined|Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)||||participants|||Number
2819335|NCT00387894|Primary|Disease Response Measured Objectively by MRI of Brain|Lack of disease progression indicates response to treatment|Every 8 weeks or as indicated|5 participants evaluable while receiving study treatment|||participants|||Number
2819336|NCT00387881|Secondary|Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score|Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.|0 - 24 hours after treatment|ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188|||Score in scale||Standard Error|Mean
2819337|NCT00387881|Secondary|Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment|Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)|2 and 4 hours after treatment|ITT Population|||Participants|||Number
2819338|NCT00387881|Secondary|Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours|Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)|1-2 and 2-4 hours after treatment|ITT Population|||Participants|||Number
2819339|NCT00387881|Secondary|Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment|Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)|1-2, and 2- 4 hours after treatment|ITT Population|||Participants|||Number
2819340|NCT00387881|Secondary|Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment|Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.|0 - 24 hours after treatment|ITT Population|||Participants|||Number
2819341|NCT00387881|Secondary|Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment|Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.|0.5, 1, 2, and 4 hours after treatment|ITT Population|||Participants|||Number
2819342|NCT00387881|Secondary|Sustained Headache Relief 2-24 Hours After Treatment|Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.|2-24 hours after treatment|ITT Population|||Participants|||Number
2819343|NCT00387881|Secondary|Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment|Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.|0.5, 1, and 4 hours after Treatment|ITT Population|||Participants|||Number
2819344|NCT00387881|Primary|Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.|Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.|2 hours through 24 hours after Treatment|The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.|||Participants|||Number
2819381|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||pmol/min||Standard Deviation|Mean
2819345|NCT00387829|Secondary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|12 months|Data reported for patients evaluable at 12 months.|||Outcome scores||Standard Error|Least Squares Mean
2819346|NCT00387829|Primary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|6 months|Data reported for patients evaluable at 6 months.|||Outcome scores||Standard Error|Least Squares Mean
2819347|NCT00387790|Secondary|The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.|Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.|One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.|Only eligible patients are included in the analysis, therefore two patients were excluded.|||Participants|||Count of Participants
2819348|NCT00387790|Secondary|Overall Survival (OS)|Percentage probability of being alive 1 year following enrollment.|One year after enrollment.|Only eligible patients are included therefore two patients were excluded from analysis.|||percent probability||95% Confidence Interval|Number
2819349|NCT00387790|Primary|One Year Event-free Survival (EFS)|Percentage probability of being event-free at 1 year following enrollment.|One year after enrollment.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome. The 2 patients who are ineligible were excluded from the Outcome Measure analysis.|||percent probability||95% Confidence Interval|Number
2819350|NCT00387764|Secondary|Percentage of Participants Who Survived Until Month 12|For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to Month 12|ATS Population|||Percentage of participants|||Number
2819351|NCT00387764|Secondary|Overall Survival (OS)|OS is defined as the interval between the date of the first dose of study medication to the date of death due to any cause. For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population|||months||95% Confidence Interval|Median
2819352|NCT00387764|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of the first dose of study medication and the date of disease progression as defined by the investigator or death due to any cause. RECIST was used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Participants who did not have disease progression or did not die were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population|||months||95% Confidence Interval|Median
2819353|NCT00387764|Secondary|Number of Participants With the Indicated Best Overall Response|The best overall response is defined as the best response recorded from the start of the treatment until disease progression (PD)/recurrence. Per RECIST: CR, the disappearance of all target and non-target lesions; PR, at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; SD, neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s); PD, at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Unknown/not evaluable is used for those participants who cannot be classified as achieving CR, PR, SD, or PD.|From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population|||participants|||Number
2819363|NCT00387764|Primary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.|From Baseline to Follow-up (up to 6.230 years)|ATP Population|||participants|||Number
2819354|NCT00387764|Secondary|Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)|The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.|From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)|ATS Population. An analysis was performed on 71 participants.|||participants|||Number
2819355|NCT00387764|Secondary|Number of Participants With a Complete Response (CR) or Partial Response (PR)|Overall tumor response is defined as the number of participants achieving either a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). RECIST guidelines were used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. CR is defined as the disappearance of all target and non-target lesions, and PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as a reference the Baseline sum LD, as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response.|From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population|||participants|||Number
2819356|NCT00387764|Primary|Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett's formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett's QTc value) were summarized using the following reference ranges: <450, 450 to 479, 480 to 499, 500 to 549, and >550 milliseconds.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.|||participants|||Number
2819357|NCT00387764|Primary|Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline|Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of <44 bpm, 44 to 100 bpm, 101 to 120 bpm, and >120 bpm was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2819358|NCT00387764|Primary|Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline|Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, >=170 mmHg) was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population|||participants|||Number
2819359|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline|Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC [leukopenia]), and prothrombin time international normalized ratio (PT [INR]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.|||participants|||Number
2819360|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline|Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.|||participants|||Number
2819361|NCT00387764|Primary|Median Time on Investigational Product|The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population|||Months||Inter-Quartile Range|Median
2819362|NCT00387764|Primary|Number of Participants With Adverse Events Related to Investigational Product|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.|From Baseline to Follow-up (up to 6.230 years)|ATS Population|||participants|||Number
2819364|NCT00387764|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.|From Baseline to Follow-up (up to 6.230 years)|All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product|||participants|||Number
2819365|NCT00387751|Secondary|Survival|Determined by time to progression, progression-free suvival, and overall survival.|6 months|Data were not collected||||||
2819366|NCT00387751|Secondary|Safety and Tolerability|Safety and tolerability of treatment, in terms of toxicity profile and incidence and rating of toxicity, according to NCI CTCAE v3.0 criteria.|6 months|Data were not collected||||||
2819367|NCT00387751|Primary|Response|"Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|4 months||||participants|||Number
2819368|NCT00387725|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Dose 1 up to 1 month after Dose 3||||percentage of participants|||Number
2819369|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3||1 month after Dose 3||||percentage of participants|||Number
2819370|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2||1 month after Dose 2||||percentage of participants|||Number
2819371|NCT00387712|Secondary|30 Foot Walk Time (Sec)|Participants are instructed to walk fast as comfortable on a straight pathway on the floor demarcated by cones. They may use their usual canes, walkers, and orthotics while they walk. The walks are timed, the value is the mean of three trials with an interval rest between each trial.|baseline to 6 month|Randomized study design with intent to treat group by time analysis of change in floor walking time between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.|||sec||Standard Error|Mean
2819372|NCT00387712|Primary|Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a|Skeletal muscle punch biopsies are obtained from the bilateral (paretic and non-paretic) vastus lateralis thigh muscle, at baseline and after 6 month interventions. Homogenized muscle messenger ribonucleic acid (mRNA) for myosin heavy chain isoforms are analyzed by real time polymerase chain reaction as fluorescent units with normalization to an acidic ribosomal protein, a housekeeping gene.|Baseline to 6 month|"The difference muscle and participant number reflects those that participated and completed pre/post biopsies.~Paretic thigh muscle, at baseline and after 6 month interventions, are analyzed for myosin heavy chain proportions. Values were the mean of duplicates run on polymerase chain reaction were normalized to a ribosomal protein mRNA."|||PCR flourescence units||Standard Error|Mean
2819373|NCT00387712|Primary|Cardiovascular Fitness (VO2 Peak)|Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.|Baseline to 6 month|Randomized study design with Intent to treat group by time analysis of change in peak cardiovascular fitness levels between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.|||ml/kg/min||Standard Error|Mean
2819374|NCT00387673|Primary|Conduct pre-and Post-training Assessments of Behavioral Outcomes Using Wolf Motor Function Test and Jebsen Taylor Hand Function Test to Measure Upper Extremity Function, Hand-held Dynamometry to Measure Pinch Grip Strength, and Semmes-Weinstein Monofilam||Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing|Project has officially closed. PI for this project has left VA without forwarding information.||||||
2819375|NCT00387660|Secondary|Number of Participants With Toxicity|All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.|Up to 36 months||||Participants|||Count of Participants
2819376|NCT00387660|Secondary|Median Survival of Patients Treated With This Regimen|The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.|||months||95% Confidence Interval|Median
2819377|NCT00387660|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.|||percentage of participants|||Number
2819378|NCT00387647|Secondary|Number of Participants With Adverse Events|Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0|48 months|All participants|||participants|||Number
2819379|NCT00387647|Secondary|Overall Survival (OS)|The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.|48 months|All participants|||months||95% Confidence Interval|Median
2819380|NCT00387647|Primary|Rate of Disease Free Survival at One Year|The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.|1 year|All participants|||percentage of participants|||Number
2819382|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||uEq/min||Standard Deviation|Mean
2819383|NCT00387621|Primary|Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||pmol/min||Standard Deviation|Mean
2819384|NCT00387621|Primary|Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min||||uEq/min||Standard Deviation|Mean
2819385|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 60 min on nesiritide treatment minus value of cGMP at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes||||pmol/min||Standard Error|Mean
2819386|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 30 min on nesiritide treatment minus value of cGMP at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)|||pmol/min||Standard Error|Mean
2819387|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 60 min on nesiritide treatment minus value of natriuresis at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes|intention to treat (ITT)|||mEq/min||Standard Error|Mean
2819388|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 30 min on nesiritide treatment minus value of natriuresis at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)|||mEq/min||Standard Error|Mean
2819389|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline|baseline and 60 minutes|intention to treat (ITT)|||pmol/min||Standard Error|Mean
2819390|NCT00387621|Primary|Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline.|baseline and 60 minutes|per protocol|||mEq/min||Standard Error|Mean
2819391|NCT00387465|Secondary|Pharmacokinetic Profile of Azacitidine as Measured by Half-life||Day 1|Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.|||hours||Standard Deviation|Mean
2819392|NCT00387465|Secondary|Average Steady State Trough Concentration (ng/mL) of Entinostat||Day 10 and 17|Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.|||ng/mL||Standard Deviation|Mean
2819393|NCT00387465|Secondary|Pharmacokinetic Profile of Azacitidine as Measured by AUC (ng*hr/mL)||Day 1|Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.|||ng*hr/mL||Standard Deviation|Mean
2819394|NCT00387465|Secondary|Pharmacokinetic Profile of Azacitidine as Measured by Cmax|Maximal concentration (ng/mL) of azacitidine|Day 1|Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants|||ng/mL||Standard Deviation|Mean
2819395|NCT00387465|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Determined by the method determined by Kaplan and Meier. 95% confidence intervals will be estimated.|Up to 1 year|Only participants who received Azacitidine 40mg/m2 were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I.|||weeks||95% Confidence Interval|Median
2819396|NCT00387465|Secondary|Pharmacokinetic Profile of Azacytidine as Measured by Tmax|Time to maximal concentration of azacitidine in the blood.|Day 1|Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.|||hours||Full Range|Median
2819397|NCT00387465|Secondary|Overall Survival|Determined by the method determined by Kaplan and Meier. 95% confidence intervals will be estimated.|Up to 1 year|Only participants who received Azacitidine 40mg/m2 were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2819459|NCT00387010|Secondary|Clinical Assessment of Patient Function - General Activities - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.|approximately week 5|Full analysis set|||participants|||Number
2819398|NCT00387465|Secondary|Major Objective Response After Immediate Subsequent Therapy as Measured by Number of Participants With PR, SD, PD After at Least 1 Cycle of Subsequent Chemotherapy|Number of participants with progressive disease (PD), stable disease (SD), or partial response (PR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) after at least 1 cycle of subsequent chemotherapy. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as >=30% decrease in the sum of the longest diameter of target lesions.|Up to 8 years|Only participants who received 40mg/m2 azacitidine and at least 1 cycle of subsequent chemotherapy (19 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. However, 2/19 deceased prior to imaging and therefore were not evaluable for this outcome measure.|||Participants|||Count of Participants
2819399|NCT00387465|Secondary|Effect of Entinostat and Azacitidine on DNA Methylation and Response|"Number of participants with decrease in DNA methylation (methylation-signature positive) on Day 10 or Day 29, and either stable disease or objective response (OR) as defined by RECIST 1.0. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as >=30% decrease in the sum of the longest diameter of target lesions, complete response is defined as disappearance of all target lesions; OR=CR+PR."|Baseline and days 10 and 29|Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. However, data was evaluable in only 26/42 participants.|||Participants|||Count of Participants
2819400|NCT00387465|Primary|(Phase II) Objective Response Rate After Treatment With Azacitidine and Entinostat as Assessed by Number of Participants With Response After at Least One Cycle of Therapy|Number of participants with progressive disease (PD), stable disease (SD), complete response (CR), or partial response (PR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0), after completing at least one cycle of therapy. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as >=30% decrease in the sum of the longest diameter of target lesions, CR is defined as the disappearance of all target lesions.|Up to 8 years|Only participants who received Azacitidine 40mg/m2 and completed at least one cycle of therapy were evaluable for this outcome measure.|||Participants|||Count of Participants
2819401|NCT00387465|Primary|(Phase I) Maximum Tolerated Dose (MTD) of Azacitidine When Given Together With Entinostat as Determined by Number of Participants Experiencing Dose-limiting Toxicity (DLT)|DLT is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|Up to 28 days|Only participants in the Phase I arms were analyzed for this outcome measure|||Participants|||Count of Participants
2819402|NCT00387426|Primary|Number of Participants With Objective Clinical Response to Sunitinib Therapy|Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).|After two 6-week treatment courses (12 weeks)|All participants assessed for response.|||participants|||Number
2819403|NCT00387348|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.|||Change in HAM-D scores||Standard Deviation|Mean
2819404|NCT00387348|Secondary|Side Effect Burden|Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.|4 weeks|Participants who completed the 4 week assessment were analyzed|||units on a scale||Standard Deviation|Mean
2819405|NCT00387348|Primary|Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder|Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|The efficacy analysis was intent to treat and all randomized participants were analyzed|||number of participants with response|||Number
2819406|NCT00387335|Secondary|Overall Survival|Time from start of treatment until death from any cause.|Up to two years||||weeks||Full Range|Median
2819407|NCT00387335|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||weeks||Full Range|Median
2819408|NCT00387335|Primary|Feasibility of Treatment|Ability to remain on treatment without dose reduction|While patient remains on treatment, up to 30 weeks||||percentage of participants||95% Confidence Interval|Number
2819409|NCT00387335|Primary|Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|While patient remains on treatment, up to 30 weeks||||percentage of participants||95% Confidence Interval|Number
2819410|NCT00387153|Secondary|Antiproliferative Activity|Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.|Every 42 days|||||||
2819411|NCT00387153|Primary|Pharmacokinetics|Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.|First 5 days of treatment (Cycle 1)|||||||
2819412|NCT00387153|Primary|Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.|"Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia.~An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation."|First 21 days on treatment (Cycle 1)|A total of 8 subjects were enrolled in the study. Statistical analyses were intended to be descriptive since the goal for the study was to determine the maximum tolerated dose and general safety and tolerability of MPC-2130.|||Participants|||Number
2819413|NCT00387127|Other Pre-specified|Number of Participants Classified as Responders, as Per Volumetric Tumor Response|No analysis was not performed.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population. A formal analysis of this outcome measure was never performed; thus data are not available and cannot be reported.||||||
2819414|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.|||Participants|||Number
2819415|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3)|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.|||Participants|||Number
2819416|NCT00387127|Secondary|Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples|"Analysis was performed for HPV infection analysis from the tumor biopsy samples obtained during the Screening period. p16 was used as a marker for HPV; thus, negative participants did not have the p16 marker."|Up to 28 days prior to the first dose of lapatinib/placebo|ITT Population|||Participants|||Number
2819417|NCT00387127|Secondary|Analysis of Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) From Tumor Samples|No analysis was performed for tumor sample RNA/DNA.|Screening|ITT Population. DNA/RNA from tumors has not been analyzed (tested); therefore, data are not available. No suitable analyses of DNA/RNA have been proposed for this small sample size of tumor samples.||||||
2819418|NCT00387127|Secondary|Plasma Proteome Analysis|Proteomic analyses of blood plasma samples were to be conducted to identify any changes in the proteome profile that could be related to the treatment response. Examination of pre-dosing (screening) plasma protein profiles could uncover novel blood-borne protein candidate biomarkers/profiles, which could be used to predict drug response.|From up to 28 days prior to the first dose of lapatinib/placebo start to 8 weeks after the first dose|ITT Population. Plasma proteome data have not been analyzed (tested); thus, data are not available to disclose. Based on the negative outcome of Study EGF102988 (NCT00424255), no suitable analyses have been proposed for this small sample size.||||||
2819419|NCT00387127|Secondary|Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha)|Paraffin-embedded tissue block (or sections) from archived tumor tissue sample, if available (from time of original diagnosis) or fresh tumor tissue, was sent for testing to determine intra-tumoral biomarker expression by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. Stained tumor slides or tissue micro arrays (TMAs) were scored by a pathologist from 0 (no expression) to 3+ (high expression). An expression level of >=2+ was considered positive.|Up to 28 days prior to the date of the first dose of lapatinib/placebo start|ITT Population. Only those participants who had sufficient tumor sample for testing were analyzed.|||Participants|||Number
2819420|NCT00387127|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Participants with OR were those who achieved either a CR or partial response (PR) from the assessment of overall tumor response at 6 months (24 weeks) following completion of CRT (data cut-off 30-Sep-2010). Per RECIST, CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the long diameter (LD) of target lesions, taking as a reference, the baseline sum LD. Data are based on Week 24 scans from participants receiving study treatment at that time point.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population|||Participants|||Number
2819421|NCT00387127|Secondary|Distant Relapse|Distant relapse is defined as the time from the date of randomization until the first occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ of part). Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population. If a participant had a distant metastasis and then died, then the participant was counted as having had an event of interest.|||Months||Inter-Quartile Range|Median
2819422|NCT00387127|Secondary|Number of Participants With Distant Recurrence of Initial Disease|Participants were analyzed for the occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ or part) after randomization in the study until data cut-off date 1-Aug-2014. Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population|||Participants|||Number
2819423|NCT00387127|Secondary|Loco-regional Control|Loco-regional control is defined as the time from the date of randomization until progression in the T or N site. Participants who died or had secondary primary malignancies in the head and neck region outside of the T and N site or distant metastasis were not counted as an event and were instead treated as competing risks. Per the TNM staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. Due to the minimal events reported (data cut-off 30-Sep-2010), valid analysis could not be performed for loco-regional control rate.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population||||||
2819424|NCT00387127|Secondary|Number of Participants With Loco-regional Recurrence of Initial Disease|Participants with loco-regional recurrence were those who had progression of disease in the T and N sites. Per the Tumor, Node, and Metastases (TNM) staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. If a participant had progression in the T or N sites, then the participant was counted as having had an event of interest.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population|||Participants|||Number
2819425|NCT00387127|Secondary|Disease-specific Survival|Disease-specific survival is defined as the time from randomization until death due to head and neck cancer.|From the date of randomization until the date of death due to disease, assessed after a median of 13 months of follow-up|ITT Population. For participants who did not die, time to death was censored at the time of last contact.|||Months||Inter-Quartile Range|Median
2819426|NCT00387127|Secondary|Number of Participants Who Died Due to Progressive Disease|The number of participants who died due to progressive disease (a >=20% increase in the sum of the longest diameter of target lesions, or the appearance of >=1 new lesion, symptomatic progression and/or unequivocal progression of existing non-target lesions), or died due to head and neck cancer without evidence of disease progression, after randomization in the study is presented, using a data cut of 1 August 2014.|From the date of randomization until the date of death due to disease under study, assessed after a median of 30.9 months|ITT Population|||Participants|||Number
2819427|NCT00387127|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Time to death (data cut-off 1-Aug-2014) was censored at the time of last contact for participants who did not die.|From the date of randomization until the date of death due to any cause, assessed after a median of 30.9 months|ITT Population|||Months||95% Confidence Interval|Median
2819428|NCT00387127|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS=the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Per RECIST, progressive disease=a >=20% increase in the sum of the longest diameter of target lesions (TLs), or the appearance of >=1 new L, symptomatic progression and/or unequivocal progression of existing non-TLs. For participants who did not progress or die at the time of reporting (data cut-off 1-Aug-2014), PFS data were censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy.|From the date of randomization until the date of disease progression or death due to any cause, assessed after a median of 22 months of follow-up|ITT Population|||Months||95% Confidence Interval|Median
2819429|NCT00387127|Secondary|Number of Participants With CR, as Assessed by the Investigator|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the CRT, as determined by the investigator. Tumor response was assessed using modified RECIST criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed after a median time of 13 months of follow-up|ITT Population|||Participants|||Number
2819430|NCT00387127|Primary|Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication|||Participants|||Number
2819431|NCT00387088|Secondary|Clinically Relevant Findings in Physical Examination and ECG|Clinically relevant findings in Physical Examination and ECG at end of treatment|End of treatment|Treated set|||participants|||Number
2819432|NCT00387088|Secondary|Marked Changes From Baseline in Vital Signs at End of Treatment|"Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.~SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.~DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.~PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm."|Baseline and end of treatment|Treated set|||participants|||Number
2819737|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Blood Pressure|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||millimeter mercury||Standard Error|Least Squares Mean
2819433|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.|||Litres||Standard Error|Least Squares Mean
2819434|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.|||Litres||Standard Error|Least Squares Mean
2819435|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.|||Litres||Standard Error|Least Squares Mean
2819436|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
2819437|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
2819438|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
2819439|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.|||Units on a scale||Standard Error|Least Squares Mean
2819440|NCT00387088|Secondary|Number of Patients With at Least One Hospitalisation for a COPD Exacerbation|Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||participants|||Number
2819441|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||hospitalisations for COPD exacerbations||Full Range|Median
2819442|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||hospitalisations for COPD exacerbations||Full Range|Median
2819443|NCT00387088|Secondary|Time to First Hospitalisation for COPD Exacerbation|Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||Days||95% Confidence Interval|Median
2819444|NCT00387088|Secondary|Number of Patients With at Least One COPD Exacerbation|Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||participants|||Number
2819445|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - naïve Estimate|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||COPD exacerbations||Full Range|Median
2819460|NCT00387010|Secondary|Patient Assessment of Ability to Enjoy Life at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819446|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - Exposure Adjusted|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||COPD exacerbations per year||Full Range|Median
2819447|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.|||Litres||Standard Error|Least Squares Mean
2819448|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.|||Litres||Standard Error|Least Squares Mean
2819449|NCT00387088|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.|||Days||95% Confidence Interval|Median
2819450|NCT00387088|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337|Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.|||Litres||Standard Error|Least Squares Mean
2819451|NCT00387036|Secondary|Exercise Endurance Time|Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.|2 Weeks|Intention to treat analysis. All patients were included.|||Minutes||Standard Deviation|Mean
2819452|NCT00387036|Primary|Standardized Dyspnea Score at Isotime During Exercise|"Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.~Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] )."|2 Weeks|Intention to treat analysis. All patients were included.|||Units on a Scale||Standard Deviation|Mean
2819453|NCT00387023|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.|3 months||||participants|||Number
2819454|NCT00387010|Secondary|Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)|During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.|up to 10 days|Safety analysis set|||participants|||Number
2819455|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.|approximately week 5|Full analysis set|||participants|||Number
2819456|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.|approximately week 5|Full analysis set|||participants|||Number
2819457|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.|approximately week 5|Full analysis set|||participants|||Number
2819458|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.|approximately week 5|Full analysis set. One participant was not assessed by the investigator.|||participants|||Number
2819461|NCT00387010|Secondary|Patient Assessment of Ability to Have Sex at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819462|NCT00387010|Secondary|Patient Assessment of Ability to Participate in Social Events at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819463|NCT00387010|Secondary|Patient Assessment of Ability to Exercise at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819464|NCT00387010|Secondary|Patient Assessment of Ability to Walk at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819465|NCT00387010|Secondary|Patient Assessment of Ability to Perform at Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819466|NCT00387010|Secondary|Patient Assessment of Ability to Go to Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.|approximately week 5|Full analysis set of participants who answered the question|||participants|||Number
2819467|NCT00387010|Secondary|Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5|The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference|approximately week 5|Full analysis set of participants who answered the questions.|||participants|||Number
2819468|NCT00387010|Secondary|Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.|Day 0 (baseline), approximately week 5|Full analysis set|||units on a scale||Standard Deviation|Mean
2819469|NCT00387010|Secondary|Change From Baseline in the Beck Depression Inventory at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores >40 indicate extreme depression.|Day 0 (baseline), approximately week 5|Full analysis set of participants who answered the questions.|||units on a scale||Standard Deviation|Mean
2819470|NCT00387010|Secondary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5|The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.|Day 0 (baseline), approximately week 5|Full analysis set|||units on a scale||Standard Deviation|Mean
2819471|NCT00387010|Primary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5|The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.|Day 0 (baseline), approximately week 5|Full analysis set|||units on a scale||Standard Deviation|Mean
2819472|NCT00386880|Primary|Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine|Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.|Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.||||participants|||Number
2819473|NCT00386776|Secondary|Completeness of Patients' Problem Lists|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
2819474|NCT00386776|Secondary|Number of Telephone Calls and E-mail Messages Between Patients and Physicians|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.||||||||
2819477|NCT00386776|Primary|Physician Post Visit Questionnaire|"The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the physician at the time of the patient visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the questions How helpful was it for your patient to have taken the computer interview before seeing you?  and the question To what extent do you think the computer summary helped you to provide better care to your patient? We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the physician responses to the post-visit questionnaires when physicians filled out the questionnaire but their patients did not."|One day after the patient visit|We analyzed post visit physician questionnaire responses for the patients who completed the medical history and who showed up for their appointment.|||units on a scale||Full Range|Mean
2819478|NCT00386776|Primary|Patient Post Visit Questionnaire|"The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the patient at the time of the visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the question How helpful was it for you to have taken the computer interview before seeing your doctor? We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the responses of three of the patients whose doctors did not complete their post-visit questionnaire."|One day after the visit with the physician|We analyzed post medical history questionnaire responses for the 23 patients who completed the medical history patients.|||units on a scale||Full Range|Mean
2819479|NCT00386776|Primary|Patient Post Medical History Assessment Questionnaire|"The questionnaire consisted of 10 Likert scales questions assessing the computer-based history. The Likert scale ranged from 1 for 'Not at all' to 10 for 'Very'.~We computed the mean of the responses to the question How helpful were the questions when thinking about your health? We also calculated a total score by averaging the mean scores of the 10 questions."|Immediately after taking the medical history|We analyzed post medical history questionnaire responses for the 32 patients who completed the medical history patients.|||units on a scale||Full Range|Mean
2819480|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment||Month 18|Treated population|||Percentage of patients|||Number
2819481|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure||Baseline and Month 18|Treated population|||mmHg||Standard Deviation|Mean
2819482|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events|adverse event data obtained from both the core study and the 6 month extension study.|Month 18||||percentage of patients|||Number
2819483|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure||Baseline and Month 18|Treated population|||mmHg||Standard Deviation|Mean
2819484|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg||.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population|||Percentage of patients|||Number
2819485|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54|Treated population|||mmHg||Standard Deviation|Mean
2819486|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population|||mmHg||Standard Deviation|Mean
2819487|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events||Month 12|Treated population: All patients who received at least one dose of Aliskiren/Valsartan|||percentage of patients|||Number
2819488|NCT00386477|Primary|Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.|Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.|1 month|Randomization|||participants|||Number
2819489|NCT00386425|Post-Hoc|Mortality for Moderate Protein C Deficiency by Infusion Duration||28 Days|ITT Population - ITT Switch-No Population, ITT patients who did not answer yes to the switch question.|||percent participants deceased|||Number
2819490|NCT00386425|Other Pre-specified|Mortality for Severe Protein C Deficiency|Twenty-eight day mortality is the patient's mortality status at the predefined timepoint of 672 hours from the start of study drug infusion. Hospital mortality is the patient's survival status at the end of the hospital stay or study day 90 (if the patient remains in the hospital).|28 Days, up to 90 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy. ITT patients with severe protein C deficiency. Severe deficiency is defined by the 24-hour local laboratory protein C value reported to the Interactive voice response system (IVRS).|||Percentage of participants|||Number
2819491|NCT00386425|Secondary|Mortality by Protein C Normalized Versus Not-normalized|Normalization was defined as having 2 consecutive protein C measurements above the lower limit of normal through Study Day 7.|28 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy|||Percentage of participants|||Number
2819492|NCT00386425|Secondary|Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period|Serious bleeding events (SBE): intracranial hemorrhage, life-threatening or fatal bleed, or bleeding event assessed as an SAE. Patients may have multiple events with onset in different time periods. SAEs include SBEs. The 3 SBEs in Alternative-Moderate Deficiency arm (days 5-8) occurred after completion of study drug infusion. One event (pleural haemorrhage) occurred same day of completion of infusion and 2 events (cerebral haemorrhage, shock haemorrhagic) occurred day after completion.|Day 0 through Day 28|Randomized participants who received randomized therapy (intention to treat population).|||number of patients with at least 1 event|||Number
2819493|NCT00386425|Secondary|28-Day Time Averaged Sequential Organ Failure (SOFA) Score|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction). SOFA scores were time-averaged.|Day 0, Day 28|ITT population|||Units on a scale||Standard Deviation|Mean
2819494|NCT00386425|Secondary|Hospital Mortality (up to Day 90)||Day 0 to hospital discharge or Day 90|ITT population|||Percentage of participants|||Number
2819495|NCT00386425|Secondary|Day 28 All-Cause Mortality||Day 0 through Day 28|ITT population|||percentage of participants|||Number
2819496|NCT00386425|Secondary|Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency|"Moderate Protein C Deficiency: A protein C level greater than half the lower limit of normal.~Severe Protein C Deficiency: A protein C level less than or equal to half the lower limit of normal."|Day 1, Day 7|ITT moderately deficient population, ITT severely deficient population|||Percent Protein C Activity||Standard Deviation|Mean
2819497|NCT00386425|Primary|Mean Change in Protein C Levels From Day 1 to Day 7|Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.|Day 1, Day 7|Intent to Treat (ITT) Last Observation Carried Forward (LOCF) population.|||Percent Protein C Activity||Standard Deviation|Mean
2819498|NCT00386360|Secondary|Height, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819499|NCT00386360|Secondary|Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12|Electrochemiluminescence assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819500|NCT00386360|Secondary|Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12|ELISA / enzyme-linked immunosorbent assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819501|NCT00386360|Secondary|Greater Trochanter BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819502|NCT00386360|Secondary|Femoral Neck BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819503|NCT00386360|Secondary|Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819504|NCT00386360|Secondary|Lumbar Spine BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819505|NCT00386360|Secondary|Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819506|NCT00386360|Secondary|Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819507|NCT00386360|Secondary|Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819508|NCT00386360|Secondary|Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819509|NCT00386360|Secondary|Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819510|NCT00386360|Secondary|Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Per Protocol (PP) Population - all patients in ITT population who had no major protocol violations.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819511|NCT00386360|Primary|Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Primary Efficacy Population - all patients in ITT population who had no major protocol violations and had an evaluable distal radius BV/TV (trabecular bone volume to tissue volume) at baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
2819512|NCT00386334|Secondary|Mean Sheehan Disability Total Scores|Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).|Weeks 0,6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819513|NCT00386334|Secondary|Mean Change From Baseline in the Sheehan Disability Scale Total Score.|Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819514|NCT00386334|Secondary|Mean Mental Component Summary of the Short Form-36 Scale Scores|This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819738|NCT00385671|Secondary|Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure|Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.|baseline through 12 weeks|All randomized patients.|||participants|||Number
2819515|NCT00386334|Secondary|Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores|Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819516|NCT00386334|Secondary|Mean Physical Component Summary of the Short Form-36 Scale Scores.|This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819517|NCT00386334|Secondary|Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale|Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6, 12, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819518|NCT00386334|Secondary|Mean Insomnia Severity Index Total Scores at Various Study Time Points|The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819519|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819520|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819521|NCT00386334|Secondary|Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points|The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Median
2819522|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points|Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Mean
2819523|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.|Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||percentage of total asleep time||Standard Deviation|Mean
2819524|NCT00386334|Secondary|Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.|The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2820527|NCT00380250|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819525|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819526|NCT00386334|Secondary|Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
2819527|NCT00386334|Secondary|Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
2819528|NCT00386334|Secondary|Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
2819529|NCT00386334|Secondary|Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||number of naps||Standard Deviation|Mean
2819530|NCT00386334|Secondary|Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
2819531|NCT00386334|Secondary|Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
2819532|NCT00386334|Secondary|Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||number of awakenings||Standard Deviation|Mean
2819533|NCT00386334|Secondary|Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819534|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819535|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
2819536|NCT00386334|Secondary|Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.|Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) & average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819537|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points|Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819538|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
2819539|NCT00386334|Secondary|Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points|Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819540|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points|Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819541|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.|||minutes||Standard Deviation|Mean
2819542|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Median
2819782|NCT00385593|Secondary|Total Number of Severe Exacerbations|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.|Baseline up to 6 months||||Exacerbations|||Number
2819543|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||percentage of total asleep time||Standard Deviation|Mean
2819544|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||percentage of total asleep time||Standard Deviation|Mean
2819545|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time at Various Study Time Points|The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819546|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819547|NCT00386334|Secondary|Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
2819548|NCT00386334|Secondary|Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.|The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
2819549|NCT00386334|Secondary|Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.|||number of naps||Standard Deviation|Mean
2819550|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose)- week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||number of naps||Standard Deviation|Mean
2819551|NCT00386334|Secondary|Mean Subject-reported Physical Well-Being at Various Study Time Points|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819552|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819783|NCT00385593|Primary|Time to First Severe Asthma Exacerbation|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.|Baseline up to 6 months||||Days||Standard Deviation|Mean
2819553|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819554|NCT00386334|Secondary|Mean Subject-reported Ability to Concentrate at Various Study Time Points|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819555|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819556|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseliine (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819557|NCT00386334|Secondary|Mean Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819558|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819559|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819560|NCT00386334|Secondary|Mean Subject-reported Daytime Alertness at Various Study Time Points.|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819561|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819562|NCT00386334|Secondary|Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819563|NCT00386334|Secondary|Mean Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819564|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819565|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819566|NCT00386334|Secondary|Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819567|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.|Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2819568|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||units on a scale||Standard Deviation|Mean
2819569|NCT00386334|Secondary|Mean Number of Awakenings (Subject-reported) at Various Study Time Points|Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
2819570|NCT00386334|Secondary|Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.|The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||number of awakenings||Standard Deviation|Mean
2819571|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.|The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||number of awakenings||Standard Deviation|Mean
2819572|NCT00386334|Secondary|Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819573|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819574|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.|Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) -week 12|Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
2819575|NCT00386334|Secondary|Mean Subject-reported Sleep Latency Reported at Various Study Time Points.|Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819576|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points|Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819577|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.|Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
2819578|NCT00386334|Secondary|Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.|The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.|||minutes||Standard Deviation|Mean
2819579|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.|The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.|||minutes||Standard Deviation|Mean
2819580|NCT00386334|Primary|Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.|The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose)-12 weeks|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.|||minutes||Standard Deviation|Mean
2819581|NCT00386308|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 6 menstrual cycles|modified intent to treat population|||mL||Standard Deviation|Least Squares Mean
2819582|NCT00386308|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Reduction from Baseline over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||percentage of subjects|||Number
2819583|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
2819584|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)|||units on a scale||Standard Deviation|Least Squares Mean
2819585|NCT00386256|Primary|HB/Phone Adherence|An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|Monthly over 3 months||||percentage of days adhered||Standard Deviation|Mean
2819586|NCT00386256|Primary|Exercise Adherence|An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|at monthly intervals, for 3-months||||percentage of days adhered||Standard Deviation|Mean
2820528|NCT00380250|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819587|NCT00386243|Secondary|Pain Catastrophizing Scale (PCS)|The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing.|Baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||units on a scale||Standard Deviation|Mean
2819588|NCT00386243|Secondary|GAD-7 Anxiety Score|This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms|Baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||units on a scale||Standard Deviation|Mean
2819589|NCT00386243|Secondary|PTSD Checklist-17 Civilian Version (PCL-C)|"The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 Not at all to 5 Extremely. Higher scores represent more severe PTSD symptoms."|Baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||score on a scale||Standard Deviation|Mean
2819590|NCT00386243|Secondary|PHQ-9 Depression|This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression|Baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||scores on a scale||Standard Deviation|Mean
2819591|NCT00386243|Secondary|SF-Mental Component Summary (MCS)|This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health|Baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||units on a scale||Standard Deviation|Mean
2819592|NCT00386243|Primary|Brief Pain Inventory (Interference)|"This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents no interference and 10 is completely interferes. The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7)."|Baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||units on a scale||Standard Deviation|Mean
2819593|NCT00386243|Primary|Roland-Morris Disability Questionnaire|This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.|at baseline and 9 months|We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis|||scores on a scale||Standard Deviation|Mean
2819594|NCT00386152|Secondary|Number of Patients (Hb >= 11 g/dL) During Study.||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit|||participants|||Number
2819595|NCT00386152|Secondary|Time to Achieve Hb >= 11 g/dL During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit|||days||95% Confidence Interval|Median
2819596|NCT00386152|Primary|Hemoglobin (Hb) Change From Baseline to Study Week 7|Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication|Baseline (Week 1) and Week 7|per-protocol (PP) population that includes a subset of the modified intent-to-treat (mITT) population with subjects who were randomized and received at least one dose of study medication, had transfusion-unrelated Hb values obtained at both baseline and Week 7, met inclusion and exclusion criteria, and had no major protocol violations up to Week 7|||g/dL||Standard Deviation|Mean
2819597|NCT00386152|Secondary|Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit|||participants|||Number
2819598|NCT00386100|Secondary|Percent Change From Baseline in Bone Alkaline Phosphatase (BSAP) at Weeks 20, 56, and 80|Blood was taken for measurement of BSAP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BSAP measurements at Week 20 or later were included.|||percent change|||Number
2819599|NCT00386100|Secondary|Percent Change From Baseline in Procollagen Type-1 N-propeptide (P1NP) at Weeks 20, 56, and 80|Blood was taken for measurement of P1NP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with P1NP measurements at Week 20 or later were included.|||percent change|||Number
2819600|NCT00386100|Secondary|Percent Change From Baseline in C-terminal Telopeptide (CTX) at Weeks 20, 56, and 80|Blood was taken for measurement of CTX. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with CTX measurements at Week 20 or later were included.|||percent change|||Number
2819601|NCT00386100|Secondary|Percent Change From Baseline in Estradiol at Weeks 20, 56, and 80|Blood was taken for measurement of estradiol. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of female participants in the bone study only. n is the number of evaluable participants, which is the number of female participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with estradiol measurements at Week 20 or later were included.|||percent change|||Number
2819602|NCT00386100|Secondary|Percent Change From Baseline in 25-hydroxy Vitamin D at Week 80|Blood was taken for measurement of 25-hydroxy vitamin D. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with 25-hydroxy vitamin D measurements at Week 20 or later were included.|||percent change|||Number
2819603|NCT00386100|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone at Week 80|Blood was taken for measurement of intact parathyroid hormone. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with intact parathyroid hormone measurements at Week 20 or later were included.|||percent change|||Number
2819604|NCT00386100|Secondary|Percent Change From Baseline in Serum Calcium at Weeks 12, 32, 56, and 80|Blood was taken for measurement of serum calcium. Percent change from baseline was based on log transformed data. Geometric mean, GM; standard error, SE. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 12, 32, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with serum calcium measurements at Week 20 or later were included.|||percent change|||Number
2819605|NCT00386100|Secondary|Percent Change From Baseline in Total Body BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
2819606|NCT00386100|Secondary|Percent Change From Baseline in Distal Radius BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
2819607|NCT00386100|Secondary|Percent Change From Baseline in Femoral Neck BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
2819608|NCT00386100|Secondary|Percent Change From Baseline in Trochanter BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
2819609|NCT00386100|Secondary|Percent Change From Baseline in Total Hip BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
2819610|NCT00386100|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mass Density (BMD) at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100%. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.|||percent change||Standard Error|Mean
2819611|NCT00386100|Secondary|Number of Participants at Final Dose Level||Baseline to Week 80 or withdrawal|Safety population. This population consisted of all participants who were randomized and received at least one dose of the study medication.|||participants|||Number
2819612|NCT00386100|Secondary|Slope of Delta-cell Function as Estimated by the Ratio deltaI/deltaG|The ratio Delta I/Delta G is calculated based on the oral glucose tolerance test (OGTT), where Delta I = (30 minute immunoreactive insulin minus 0 minute immunoreactive insulin) and Delta G = (30 minute plasma glucose minus 0 minute plasma glucose). The 0 minute values are fasting insulin and glucose; the 30 minute values are taken 30 minutes after the oral glucose challenge. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants from US and Mexico sites with a value at baseline and at the specified visit, were analyzed.|||ratio||Standard Error|Mean
2819613|NCT00386100|Secondary|Percent Change From Baseline in in HOMA-S and HOMA-B to Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of homeostasis model assessment for insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B). Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. GM, geometric mean; SE, standard error.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
2819614|NCT00386100|Secondary|Change in C-peptide From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for C-peptide measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||mmol/l||Standard Error|Mean
2819615|NCT00386100|Secondary|Change in Fasting Insulin From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for fasting insulin measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||picomoles per Liter (pmol/l)||Standard Error|Mean
2819616|NCT00386100|Secondary|Percent Change in Free Fatty Acids (FFA) From Baseline at Week 80 (US and Mexico Subset of Participants).|Blood was taken for measurement of FFA. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
2819617|NCT00386100|Secondary|Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
2819618|NCT00386100|Secondary|Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants )|Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change|||Number
2819619|NCT00386100|Secondary|Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80|Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 32 evaluable population with LOCF from Week 32. n is the number of evaluable participants, which is defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest.|||percent change|||Number
2820529|NCT00380250|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3||||Scale score||Standard Deviation|Mean
2819620|NCT00386100|Secondary|Number of Participants Achieving Treatment Failure|Treatment failure was defined as an HbA1c level >= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time.|Randomization to treatment failure (up to Week 80)|ITT Population. Only evaluable participants, defined as the number of subjects with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis|||participants|||Number
2819621|NCT00386100|Secondary|Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80|Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG <=6 mmol/L (110 mg/dL) and <7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||participants|||Number
2819622|NCT00386100|Secondary|Change From Baseline in FPG at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||mmol/l||Standard Deviation|Mean
2819623|NCT00386100|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value.|Baseline and Week 80|ITT Population. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis.|||millimoles per Liter (mmol/l)||Standard Error|Mean
2819624|NCT00386100|Secondary|Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80|Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC <=6% and <7% at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||participants|||Number
2819625|NCT00386100|Primary|Change From Baseline in HbA1c at Week 80|Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis.|Baseline and Week 80|Intent-to-Treat (ITT) Population: all participants who were randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed.|||percent change||Standard Error|Mean
2819626|NCT00386100|Secondary|Mean Change From Baseline in HbA1c at Week 80|Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF: a subset of the ITT Population with LOCF starting at Week 32. Only participants with assessment(s) at Week 32 or later were included in this population. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.|||percent change||Standard Deviation|Mean
2819627|NCT00386022|Primary|Effect of Estrogen on Pituitary Response to GnRH|LH and FSH responses to each of 4 GnRH doses, expressed as change in amplitude [amp] from peak to nadir between plus estrogen and baseline conditions|Peak hormone level within 2 hours post GnRH doses||||IU/L||Standard Error|Mean
2819628|NCT00386022|Primary|Pituitary Response to GnRH|Baseline LH and FSH responses to each of 4 GnRH doses - peak to nadir amplitude expressed as percent (%) change from nadir|Peak hormone level within 2 hours post GnRH doses||||Percent change||Standard Error|Mean
2819629|NCT00386009|Secondary|Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests|Laboratory tests that were statistically significant and clinically adverse would be reported for safety.|Baseline and 12 weeks|All randomized participants.|||significant and clinically adverse labs|||Number
2819630|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||units on a scale||Standard Deviation|Mean
2819631|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction|Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.|Baseline and 12 weeks|Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint.|||milliliters||Standard Deviation|Mean
2819632|NCT00386009|Secondary|Presence of Involuntary Detrusor Contractions During Bladder Filling||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||participants|||Number
2819633|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies|BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||units on a nomogram||Standard Deviation|Mean
2820530|NCT00380250|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819634|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies|BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||units on a nomogram||Standard Deviation|Mean
2819635|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies|Max Pdet was defined as the maximum detrusor pressure observed during voiding.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||centimeters of water (cm H20)||Standard Deviation|Mean
2819636|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies|Vcomp was defined as the volume of voided urine measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
2819637|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies|Qave was measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters per second||Standard Deviation|Mean
2819638|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies|Qmax was measured duirng pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters per second||Standard Deviation|Mean
2819639|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies|Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
2819640|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies|Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
2819641|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies|PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
2819642|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters||Standard Deviation|Mean
2819643|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies|Qave was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||millilters per second||Standard Deviation|Mean
2819644|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies|Qmax was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||milliliters per second||Standard Deviation|Mean
2819645|NCT00386009|Primary|Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.|||centimeters of water (cm H20)||Standard Deviation|Mean
2819646|NCT00385996|Secondary|Disease-free Survival (DFS)|Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites.|From date of erlotinib start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 25 months.||||Months||Inter-Quartile Range|Median
2819647|NCT00385996|Secondary|Time-to-progression (TTP)|Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites.|Every 3 months for the first 6 months, then yearly for 2 years.||||Months||Inter-Quartile Range|Median
2819648|NCT00385996|Secondary|Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.|"Safety will be measured by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.~Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.~Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE."|From Day 1 until 30 days after the last study drug dose,|Per protocol|||Participants|||Count of Participants
2819649|NCT00385996|Primary|Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.|High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.|High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.|Population per protocol|||Participants|||Count of Participants
2819650|NCT00385944|Secondary|Correlation of MPA to 20 μM ADP and PRU|Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU|Baseline through 29 days of treatment||||Correlation coefficient|||Number
2819651|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)|Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.|14 days after maintenance dose (MD)||||Participants|||Number
2819652|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.|14 days after maintenance dose (MD)||||Participants|||Number
2819653|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the second maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at Day 29.|||Percentage aggregation||Standard Deviation|Mean
2819654|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the first maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at 14 days after the first maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
2819655|NCT00385944|Secondary|Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)||||Percentage aggregation||Standard Deviation|Mean
2819656|NCT00385944|Secondary|Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|Baseline to 6-18 hrs post loading dose (LD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage aggregation||Standard Deviation|Mean
2819657|NCT00385944|Secondary|Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)|Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.|14 days after maintenance dose (MD)||||Participants|||Number
2819658|NCT00385944|Secondary|P2Y12 Reaction Units (PRU)|P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.|14 days after maintenance dose (MD)||||PRU||Standard Deviation|Mean
2819659|NCT00385944|Secondary|Platelet Reactivity Index (PRI)|"Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:~PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100~Lower PRI% values indicate greater P2Y12 receptor blockade."|14 days after maintenance dose (MD)||||Percentage PRI||Standard Deviation|Mean
2819660|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
2819661|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
2819662|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 5 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
2819663|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 20 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)|||Percentage inhibition||Standard Deviation|Mean
2819667|NCT00385944|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)|Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).|14 days after maintenance dose (MD)|The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.|||Percentage aggregation||Standard Deviation|Mean
2819668|NCT00385918|Secondary|Step Activity Monitor|"The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.~This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months||||steps||Standard Deviation|Mean
2819669|NCT00385918|Secondary|10-meter Walk|"A functional capacity test to measure speed.~This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.~Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months||||seconds||Standard Deviation|Mean
2819670|NCT00385918|Secondary|Six Minute Walk|"A functional capacity test to evaluate walking distance during a 6-minute time frame.~This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured Baseline (Time point 0) and 3 months||||meters||Standard Deviation|Mean
2819671|NCT00385918|Secondary|Bone Mineral Content|"DXA assessment of bone mineral content.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months||||kg||Standard Deviation|Mean
2819672|NCT00385918|Secondary|Lean Muscle Mass|"DXA measurement of total lean muscle mass.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months||||kg||Standard Deviation|Mean
2819673|NCT00385918|Primary|Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.|"Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months||||ml/kg/min||Standard Deviation|Mean
2819674|NCT00385918|Secondary|Percent Body Fat|"An assessment of percent body fat as determined by DXA analysis.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months||||percent of total mass||Standard Deviation|Mean
2819675|NCT00385918|Secondary|Body Mass|"DXA assessment of total body mass.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months||||kg||Standard Deviation|Mean
2819676|NCT00385918|Primary|Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments|"Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months|A single outlier point in the baseline data in one control subject was noted. Laboratory journal notes for this subject indicated that this individual had far more episodes of robotic treadmill stops during his baseline testing due to a high degree of spasticity. Given this, we felt justified in excluding this outlier from further data analysis.|||ml/kg/min||Standard Deviation|Mean
2820079|NCT00383500|Primary|Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy|Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups|36 months|All enrolled patients in the trial who did not withdraw or were lost to follow-up|||participants|||Number
2819677|NCT00385840|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||fold increase||95% Confidence Interval|Mean
2819678|NCT00385840|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||subjects|||Number
2819679|NCT00385840|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||subjects|||Number
2819680|NCT00385840|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.|||titers||95% Confidence Interval|Geometric Mean
2819681|NCT00385840|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2819682|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2819683|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.|||subjects|||Number
2819684|NCT00385840|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.|||subjects|||Number
2819685|NCT00385827|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.|Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.|||days||95% Confidence Interval|Median
2819686|NCT00385827|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2819734|NCT00385671|Secondary|Number of Participants With Treatment-emergent Elevated Blood Pressure|"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.~Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
2819687|NCT00385827|Secondary|Number of Participants With Palliative Response|Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years|Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study.||||||
2819688|NCT00385827|Secondary|Time to Clinical Deterioration (TtCD)|The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.|||days||95% Confidence Interval|Median
2819689|NCT00385827|Primary|Part 2: Progression Free Survival (PFS)|The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.|Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years|Intent-to-treat (ITT) population in Part 2 included all randomized participants.|||days||95% Confidence Interval|Median
2819690|NCT00385827|Primary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.|Baseline up to 12 weeks after last dose administration|Safety population in Part 1 included all participants who received at least one dose of study drug.|||participants|||Number
2819691|NCT00385801|Secondary|Amygdala Volume by MRI|Measure of Dispersion/Precision not calculated, and raw data are no longer available|12 weeks|Measure of Dispersion/Precision not calculated, and raw data are no longer available||||||
2819692|NCT00385801|Secondary|Cocaine Craving|The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)|12 weeks|Mixed model repeated measures analysis of variance was performed.|||units on a scale||Standard Deviation|Mean
2819693|NCT00385801|Primary|Cocaine Use by Quantitative Urine Samples|After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below|12 weeks|Mean number of visits at which participants submitted urine samples with undetectable urine benzoylecgonine (UBE)|||visit with negative UBE||Standard Deviation|Mean
2819694|NCT00385801|Primary|Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues|Measure of Dispersion/Precision not calculated, and raw data are no longer available|12 weeks|Measure of Dispersion/Precision not calculated, and raw data are no longer available||||||
2819695|NCT00385788|Primary|Transplant Related Mortality Rate|Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.|Transplant to 100 days post transplant||||Participants|||Count of Participants
2819696|NCT00385762|Primary|Sperm Morphology|percent of sperm with normal shape|2 months post initial visit||||percent of sperm with normal shape||Standard Deviation|Mean
2819697|NCT00385762|Primary|Sperm Motility|percent of sperm with movement|2 months post initial visit||||Percent of sperm with movement||Standard Deviation|Mean
2819698|NCT00385762|Primary|Sperm Concentration|number of sperm per cubic centimeter of semen|2 months post initial visit||||number of sperm per cubic centimeter||Standard Deviation|Mean
2819699|NCT00385762|Primary|Semen Volume|measured in mL|2 months post initial visit||||mL||Standard Deviation|Mean
2819700|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants enrolled under any version of the protocol who took systemic corticosteroids (CS) at Baseline, received at least 1 dose of study drug, and were systemic CS-free at Week 52 were included. Nonresponder imputation was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders post-escalation.|||Proportion of participants|||Number
2819701|NCT00385736|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819702|NCT00385736|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819703|NCT00385736|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819704|NCT00385736|Secondary|Proportion of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819705|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52|"Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of >= 2 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; subjects who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819706|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819707|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52|"Clinical remission per partial Mayo score is defined as a partial Mayo score <= 2 and no individual subscore > 1.~The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819708|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.|||Proportion of participants|||Number
2819709|NCT00385736|Secondary|Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819735|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Body Weight|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||kilogram||Standard Error|Least Squares Mean
2819710|NCT00385736|Secondary|Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819711|NCT00385736|Secondary|Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Stool Frequency Subscore ranges from 0-3 as follows:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819712|NCT00385736|Secondary|Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819713|NCT00385736|Secondary|Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819714|NCT00385736|Secondary|Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo).|"Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819715|NCT00385736|Secondary|Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819716|NCT00385736|Secondary|Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819717|NCT00385736|Secondary|Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819718|NCT00385736|Secondary|Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819719|NCT00385736|Secondary|Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819720|NCT00385736|Secondary|Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819721|NCT00385736|Primary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.|||Proportion of participants|||Number
2819722|NCT00385723|Primary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Baseline & 4 months|intention to treat|||scores on a scale||Standard Error|Least Squares Mean
2819723|NCT00385723|Primary|Serum ln(IL-6)|log-transformed serum Interleukin-6 (IL-6)|Baseline & 4 months|intention to treat|||pg/ml (raw IL-6)||Standard Error|Least Squares Mean
2819724|NCT00385723|Primary|Serum ln(TNF-a)|log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)|Baseline & 4 months|intention to treat|||pg/ml (raw TNF-a)||Standard Error|Least Squares Mean
2819725|NCT00385684|Secondary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort.|6 weeks||||units on a scale||Standard Deviation|Mean
2819726|NCT00385684|Primary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.|Two (2) weeks||||units on a scale||Standard Deviation|Mean
2819727|NCT00385671|Secondary|Number of Patients With Treatment-Emergent Elevated Laboratory Analytes|Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
2819728|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hemoglobin A1C||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||percent||Standard Deviation|Mean
2819729|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||millimole/liter||Standard Deviation|Mean
2819730|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Total Bilirubin||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||micromole/liter||Standard Deviation|Mean
2819731|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels|Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units/liter||Standard Deviation|Mean
2819732|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Changes in Body Weight|"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.~Treatment-emergent low body weight: weight at last visit <=93% of baseline weight."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2819733|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Elevated Heart Rate|Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
2819739|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks|Analyzed were all participants with a baseline and at least 1 non-missing post-baseline value. Last observation carried forward analysis.|||units on a scale||Standard Error|Least Squares Mean
2819740|NCT00385671|Secondary|Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)|Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.|baseline, 12 weeks|The per-protocol sub-population of all randomized participants with a baseline value and >= 1 non-missing post-baseline value (modified intent-to-treat population) was included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819741|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)|"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.~It was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible."|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819742|NCT00385671|Secondary|Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
2819743|NCT00385671|Secondary|Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
2819744|NCT00385671|Secondary|Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
2819745|NCT00385671|Secondary|Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||days||95% Confidence Interval|Median
2819746|NCT00385671|Secondary|Summary of Number of Participants Who Discontinued|Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2819747|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale|The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2820531|NCT00380250|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819748|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819749|NCT00385671|Secondary|Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms|Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||coefficient|||Number
2819750|NCT00385671|Secondary|Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2819751|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819752|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.|||participants|||Number
2819753|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819754|NCT00385671|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation||baseline through 12 weeks|All participants who were enrolled in the study.|||participants|||Number
2819755|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819756|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)|The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2820532|NCT00380250|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819757|NCT00385671|Secondary|Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2819758|NCT00385671|Secondary|Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2819759|NCT00385671|Secondary|Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||participants|||Number
2819760|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819761|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819762|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819763|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819764|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819765|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819766|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819767|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819768|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819769|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819770|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 Weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819771|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819772|NCT00385671|Secondary|Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2819773|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819774|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819775|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819776|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819777|NCT00385671|Primary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2819778|NCT00385593|Secondary|Peak Expiratory Flow (PEF)|Peak expiratory flow (PEF)|6 months (end of the study)||||L/min||Full Range|Mean
2819779|NCT00385593|Secondary|Change in the Asthma Control Questionnaire(ACQ) Score|The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)|Daily 14 days prior to each of visit 2-4||||Scores on a scale||Full Range|Mean
2819780|NCT00385593|Secondary|Use of Inhaled Steroids|Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)|Baseline up to 6 months||||micrograms||Full Range|Mean
2819781|NCT00385593|Secondary|Mean Use of as Needed Medication|Mean use of as needed medication during the treatment period|Baseline up to 6 months||||Inhalations||Full Range|Mean
2819784|NCT00385580|Secondary|Mean Plasma Concentration at Dose 50 mg (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
2819785|NCT00385580|Secondary|Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
2819786|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. In treatment group (100 mg, QD), no participant received a 70 mg at PK collection day.|||ng/mL||Standard Deviation|Mean
2819787|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
2819788|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
2819789|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.|||ng/mL||Standard Deviation|Mean
2819790|NCT00385580|Secondary|Median Number of Months of BAP Response|The median number of months of the BAP response was calculated for participants with baseline BAP <= ULN, from first dose of dasatinib to the first time BAP is above ULN. For participants with baseline BAP > ULN, it was the time from BAP response to the first time BAP was above ULN. For participants with baseline BAP =< ULN or BAP, and no BAP above ULN, last BAP assessment date was used. The median number of months of response was not defined for participants with baseline value > ULN, that never achieved BAP response.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a BAP response|||months||95% Confidence Interval|Median
2819791|NCT00385580|Secondary|Number of Participants With BAP Response|BAP is a measure of bone metabolism. A BAP response is calculated for participants with a baseline BAP value > ULN. It is defined as on-study BAP values within normal limits.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline BAP value > ULN and at least 1 on-study value.|||participants|||Number
2819792|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value >ULN and at least 1 on-study value.|||participants|||Number
2819793|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value <=ULN and at least 1 on-study value.|||participants|||Number
2819794|NCT00385580|Secondary|Median Number of Months of uNTx Response|uNTx is a measure of bone metabolism.The median number of months of uNTx response was calculated for participants with baseline uNTx =< ULN and uNTx progression during treatment, from first dose of dasatinib to uNTx progression.For participant with baseline uNTx above ULN, it was time from uNTx response to uNTx progression.For participants with baseline uNTx equal to or below ULN or uNTx response and no uNTx progression, the date of last uNTx assessment was used. Duration of uNTx response was not defined for participants with baseline value greater than ULN who never achieved uNTx responses.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a uNTx response.|||months||95% Confidence Interval|Median
2819795|NCT00385580|Secondary|Number of Participants With a uNTx Response|uNTx is a measure of bone metabolism. uNTx response is defined for participants with baseline uNTx above ULN. It is defined as either on-study uNTx values decreasing to within normal limits or 35% or more decrease in uNTx from baseline, whichever happens first.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline uNTx value > ULN and at least 1 on-study value.|||participants|||Number
2820533|NCT00380250|Secondary|Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 3|ITT with LOCF|||SBM/week||Standard Deviation|Mean
2819796|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value >ULN and at least 1 on-study value.|||participants|||Number
2819797|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value <=ULN and at least 1 on-study value.|||participants|||Number
2819798|NCT00385580|Secondary|Number of Participants With QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
2819799|NCT00385580|Secondary|Number of Participants With Positive Urinalysis|"Participants' urine samples were tested for the presence of blood, glucose and protein. If these substances were present in a participant's urine, the results were given as positive."|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
2819800|NCT00385580|Secondary|Number of Participants With Abnormal Lactate Dehydrogenase (LD)|LDH is a laboratory safety parameter. Normal ranges for LD vary with both age and disease status, and another reason for variation in upper limit of normal (ULN) and lower limit of normal (LLN) is that LD was measured via a local (versus a standardized) laboratory. It is therefore not possible to provide one ULN and LLN for the population.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
2819801|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous|Abnormalities were graded per the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; sodium: Grade 3: 120-<130 or >155-160mEq/L, Grade 4: <120 or >160 mEq/L; creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; potassium: Grade 3: 2.5 -<3.0 or >6.0 -7.0 mEq/L, Grade 4: < 2.5 or >7.0 mEq/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
2819802|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
2819803|NCT00385580|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the NCI CTC, version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L. Leukocytes: Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
2819804|NCT00385580|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. Drug-related AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
2819805|NCT00385580|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
2819806|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 36|FAPSI-8:index of symptoms/concerns when assessing value of treatment for advanced prostate cancer.Participants respond to each item on 5-point Likert-type scale:0 (not at all) to 4 (very much).GP1:I have lack of energy,GP4:I have pain,GE6:I worry that my condition will get worse,C2:I am losing weight,P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do,P7:I have difficulty urinating,P8:My problems with urinating limit my activities. The number of participants for whom these data are available is too small for analysis.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants. The number of participants for whom this data are available is too small for analysis.||||||
2820080|NCT00383448|Secondary|Number of Patients With Chronic Graft Versus Host Disease (GVHD)|Graft-Versus-Host Disease is a severe complication created by infusion of donor cells into a foreign host. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|1 year||||Participants|||Count of Participants
2819807|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 24|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||Units on a scale||Full Range|Median
2819808|NCT00385580|Secondary|Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36|The FAPSI-8 is a symptom index comprised of the most important clinician-rated symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. It includes 8 items developed to measure symptoms/concerns specific to prostate cancer such as fatigue, pain (3-items), weight loss, difficulty with urination (2-items) and concerns about the condition becoming worse. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much).|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||Units on a scale||Full Range|Median
2819809|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 12|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||Units on a scale||Full Range|Median
2819810|NCT00385580|Secondary|Median Number of Months to Disease Progression|Measured from date of first dose to date of first 3 consecutive measurements that confirm PSA progression, date of disease progression,or death date.Disease progression:progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI),loss of PSA response or Investigator-defined clinical progression based on physical examination,history,symptoms,and ECOG-PS.For participants who did not progress or die,date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||months||95% Confidence Interval|Median
2819811|NCT00385580|Secondary|Number of Participants With Disease Progression|Disease progression: progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI), not as evaluated by bone scan (non-measurable lesions included visceral and bone lesions), loss of PSA response (only for participants who achieved a PSA response) or Investigator-defined clinical progression based on physical examination, history, symptoms, and ECOG-PS. For participants who did not progress or die, date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.|||participants|||Number
2819812|NCT00385580|Secondary|Percentage of Participants With Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|Participants with confirmed improved bone scan.|||Percentage of Participants|||Number
2819813|NCT00385580|Secondary|Number of Participants With a Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.|||participants|||Number
2819814|NCT00385580|Secondary|Number of Participants With CR, PR or SD|Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.|||participants|||Number
2819815|NCT00385580|Secondary|Number of Participants With CR or PR|Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.|||participants|||Number
2819816|NCT00385580|Secondary|Number of Participants With Increase in PSA Doubling Time|PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements.|||participants|||Number
2820081|NCT00383448|Secondary|Number of Patients With Acute Graft Versus Host Disease (GVHD)|Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. Acute GVHD can occur once the donor's cells have engrafted in the transplant recipient. The symptoms typically appear within weeks after transplant.|Day 100||||Participants|||Count of Participants
2819817|NCT00385580|Secondary|Number of Participants With Decrease in PSA Log Slope|PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||participants|||Number
2819818|NCT00385580|Secondary|Number of Participants With Decrease in PSA Velocity|PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||participants|||Number
2819819|NCT00385580|Secondary|Number of Months of Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a decrease in PSA by at least 50% from baseline|||months|||Number
2819820|NCT00385580|Secondary|Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||Percentage of Participants|||Number
2819821|NCT00385580|Secondary|Number of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.|||participants|||Number
2819822|NCT00385580|Primary|Percentage of Participants With a Response|Response = confirmed PSA response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD [=>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on RECIST.|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.|||Percentage of Participants||95% Confidence Interval|Number
2819823|NCT00385580|Primary|Number of Participants With a Response|Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =>30% in sum of longest diameter [LD] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease [PD: =>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors [RECIST].|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.|||participants|||Number
2819824|NCT00385541|Secondary|Mean Score on the Ramsey Scale of Sedation|The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).|1 hour after surgery, 8 hours after surgery||||score on scale||Standard Deviation|Mean
2819825|NCT00385541|Secondary|The Number of Patients Who Vomited||1 hour after surgery, 8 hours after surgery||||participants|||Number
2819826|NCT00385541|Secondary|Pain Assessment by Patient|Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery||||Units on a scale||Standard Deviation|Mean
2819827|NCT00385541|Secondary|Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale|The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).|1 hour after surgery, 8 hours after surgery||||Units on a scale||Standard Deviation|Mean
2819828|NCT00385541|Primary|Nausea Assessment by Patient|Nausea scale range: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
2819829|NCT00385515|Secondary|Number of Participants With Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis.|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle||||Participants|||Number
2819830|NCT00385515|Primary|Duration of Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle|Analysis only includes subjects randomized to the 30mg dose of SNX-1012|||Days||Standard Deviation|Mean
2819831|NCT00385268|Primary|Urine Benzoylecgonine Tests (UBT)|The primary outcome measure for this trial was qualitative urine benzoylecgonine tests (UBT) obtained twice weekly. Urine collection was monitored by temperature checks. Samples less than 90 degrees, or greater than 100 degrees Fahrenheit were considered invalid and were not accepted. Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive.|8 weeks||||% of negative urine benzoylecgonine test||Standard Deviation|Mean
2819832|NCT00385268|Primary|Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen|cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)|8 weeks||||cocaine abstinent weeks||Standard Deviation|Mean
2819833|NCT00385255|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the whole study period (from Day 0 to Month 2)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2819834|NCT00385255|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day period (Day 0-30) following each vaccination, up to 2 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2819835|NCT00385255|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain, muscle aches and shivering. Any = occurrence of the symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.|During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2819836|NCT00385255|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.|During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2819837|NCT00385255|Secondary|Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers|Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs).|At Month 1 post-Fluarix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2819838|NCT00385255|Secondary|Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens|Booster responses for anti-PT, anti-FHA and anti-PRN are defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL), one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with Boostrix®.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819839|NCT00385255|Secondary|Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens|Booster responses for anti-D and anti-T antibodies are defined as: For initially seronegative subjects [pre-vaccination concentration below (<) cut-off 0.1 IU/mL]: antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL), one month after vaccination with Boostrix®; For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with Boostrix®.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819840|NCT00385255|Secondary|Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0 and Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2819841|NCT00385255|Secondary|Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL).|At Day 0 and Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2819842|NCT00385255|Secondary|Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value|A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819843|NCT00385255|Primary|Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B|Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.|At Month 1 post-Fluarix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819844|NCT00385255|Primary|Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza|The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.|At Month 1 post-Fluarix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819845|NCT00385255|Primary|Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2819846|NCT00385255|Primary|Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value|The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).|At Month 1 post-Boostrix® vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819847|NCT00385255|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.|At Month 1 post-Boostrix® vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2819848|NCT00385216|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days||||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2819849|NCT00385216|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days||||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2819850|NCT00385216|Secondary|Heart Rate|Heart rate reported in beats per minute (BPM)|5 days||||Beats per minute (BPM)||Standard Deviation|Mean
2819851|NCT00385216|Secondary|hydrocodone5 mg/Acetaminopgen 325 mg Use||5 days|||||||
2819852|NCT00385216|Secondary|Nausea||5 days|||||||
2819853|NCT00385216|Primary|Pain Reported by Patient|Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.|1 day||||Numeric Rating Scale (NRS)||Standard Deviation|Mean
2819854|NCT00385203|Secondary|Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 16|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||cm3||95% Confidence Interval|Mean
2819855|NCT00385203|Secondary|Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 8|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||cm3||95% Confidence Interval|Mean
2819856|NCT00385203|Secondary|Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 16 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 16.|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||mm||95% Confidence Interval|Mean
2819857|NCT00385203|Secondary|-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 8 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 8|As per the protocol the formal statistical analysis was performed for the GIST grouppatients only, STS patients were summarised (not STS patients). For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).|||mm||95% Confidence Interval|Mean
2819858|NCT00385203|Secondary|Objective Tumour Response, Investigator Review|Number of patients with complete (CR) /partial response (PR) (based on RECIST) as assessed by the Investigator. CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.||||Participants|||Number
2819859|NCT00385203|Primary|Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.|SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients|FDG-PET assessment at Baseline and 29 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 29).|||g/mL||95% Confidence Interval|Mean
2820082|NCT00383448|Secondary|Concentrations of Mycophenylate Mofetil (MMF)|"MMF levels are to be sent on day +3 to the main laboratory for determinations of MMF kinetics.~Data was not collected on this outcome measure and is not available for reporting."|Day 3|Data was not collected on this outcome measure and is not available for reporting.||||||
2819860|NCT00385203|Primary|Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.|[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.|Baseline and 8 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 8).|||g/mL||95% Confidence Interval|Mean
2819861|NCT00385138|Secondary|Incidence of Stroke|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819862|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819863|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819864|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819865|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819866|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819867|NCT00385138|Secondary|Incidence of All-cause Mortality, MI, or IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data|||participants|||Number
2819868|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm|Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.|randomization through 48 hours post randomization|Safety population|||participants|||Number
2819869|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population|||participants|||Number
2819870|NCT00385138|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population|||participants|||Number
2819871|NCT00385138|Secondary|Incidence of GUSTO Severe / Life-threatening|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population|||participants|||Number
2819872|NCT00385138|Secondary|Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]|mITT population A patient could have multiple procedural events.|During index PCI|mITT population, based on available data|||participants|||Number
2819873|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 1 year post randomization|mITT population, based on available data|||participants|||Number
2819874|NCT00385138|Secondary|Incidence of Stroke|mITT|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819875|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819876|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819877|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819878|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819879|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819880|NCT00385138|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|mITT population; (composite incidence)|randomization through 48 hours post randomization|mITT population, based on available data|||participants|||Number
2819881|NCT00385008|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Day 30|The Safety Population consisted of all participants who were randomized and received at least one dose of study medication.|||Participants|||Count of Participants
2819882|NCT00385008|Primary|Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan|Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administered (For 30 days)|Scintigraphy Population|||hr||Full Range|Median
2820534|NCT00380250|Secondary|Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 2|ITT with LOCF|||SBM/week||Standard Deviation|Mean
2819883|NCT00385008|Primary|Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine|Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administered (For 30 days)|Scintigraphy Population|||hr||Full Range|Median
2819884|NCT00385008|Primary|Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet|Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administered (For 30 days)|Scintigraphy Population|||hr||Full Range|Median
2819885|NCT00385008|Primary|Tmax for Eletriptan|Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.|PK parameter Population|||hr||Full Range|Median
2819886|NCT00385008|Primary|Time of Maximal Drug Concentration (Tmax) for Sumatriptan and Naproxen|Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.|PK parameter Population|||hr||Full Range|Median
2819887|NCT00385008|Primary|Cmax for Eletriptan|Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.|PK parameter Population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2819888|NCT00385008|Primary|Maximum Observed Drug Concentration (Cmax) for Sumatriptan and Naproxen|Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.|The PK parameter Population|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2819889|NCT00385008|Primary|Mean AUC (0-inf) and AUC (0-2) for Eletriptan|Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.|The PK parameter Population. Only those participants available at the specified time points were analyzed.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2819890|NCT00385008|Primary|Mean Area Under the Drug Concentration Time Curve (AUC) From Time of Dosing Through 2 Hour Post-dose [AUC (0-2)], Through 24 Hour [AUC (0-24)] and AUC From Time of Dosing Extrapolated to Infinity [AUC (0-inf)] for Sumatriptan and Naproxen|Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.|Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.|"PK parameter population comprised of all participants in the PK concentration population for whom PK parameters were calculated.~PK concentration population comprised of all participants who had a sample obtained and analyzed. Only those participants available at the specified time points were analyzed."|||microgram*hr per mL (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2820083|NCT00383448|Secondary|Number of Patients Whose Death Was Related to the Transplant|In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.|Day 100||||Participants|||Count of Participants
2819891|NCT00385008|Primary|Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan|Scintigraphic images were analyzed in a time-lapse format and regions of interest were drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with pharmacokinetic (PK) blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).|Day 1 of each treatment administration (For 30 days)|Scintigraphy Population consisted of all participants with evaluable data from the scintigraphic images.|||hours (hr)||Full Range|Median
2819892|NCT00384956|Post-Hoc|Progression-free Survival (PFS)|"PFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.~Disease progression~for patients w/ <5% blasts; a ≥50% increase in blasts to >5% blasts~for patients w/ 5% to 10% blasts; a ≥50 increase to >10% blasts~for patients w/ 10% to 20% blasts; a ≥50% increase to >20% blasts~for patients w/ 20% to 30% blasts; a ≥50% increase to >30% blasts~One or more of the following ≥50% decrement from maximum remission/response levels in granulocytes or platelets, reduction in hemoglobin concentration by ≥2 g/dL or transfusion dependence"|2 years after first dose of study drug or until participant is lost to follow-up or dies||||days||Full Range|Median
2819893|NCT00384956|Post-Hoc|Duration of Response (DOR)||2 years after first dose of study drug or until participant is lost to follow-up or dies||||days||Full Range|Median
2819894|NCT00384956|Secondary|Rate of Relapse After Hematopoietic Stem Cell Transplant in Individuals Treated With 5-azacitidine Prior to Transplant.||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.||||||
2819895|NCT00384956|Secondary|Rate of Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|2 years after first dose of study drug or until participant is lost to follow-up or dies||||days||Full Range|Median
2819896|NCT00384956|Secondary|Rate of Cytogenetic Response||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.||||||
2819897|NCT00384956|Post-Hoc|Time to Best Response||4 weeks following last dose of azacitidine [median number of cycles 4.5 (1-20)]||||days||Full Range|Median
2819898|NCT00384956|Secondary|Rate of Transfusion Independence||4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]|Only participants with baseline transfusion dependence were assessed for this outcome measure.|||participants|||Number
2819899|NCT00384956|Secondary|Rate of Hematologic Improvement|International Working Group (IWG) for Myelodysplasia (MDS).|4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]||||participants|||Number
2819900|NCT00384956|Primary|Rate of Complete Remission (CR) and Partial Remission (PR)|"Defined according to the modified International Working Group (IWG) (2006) response criteria for myelodysplasia:~CR=bone marrow with <5% myeloblasts and 0% peripheral blasts, hemoglobin ≥11g/dL, platelets ≥ 100 x 10^9/L, and neutrophils ≥1.0 x 10^9/L. Residual dysplasia was allowed.~PR= All of the CR criteria if abnormal before treatment except: bone marrow blasts decreased by ≥50% over pretreatment but still >5%."|After 4 cycles of therapy (up to 112 days after start of treatment)||||participants|||Number
2819901|NCT00384930|Primary|Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2819902|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819903|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow|Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||milliliter per second||Standard Deviation|Mean
2819904|NCT00384930|Secondary|"Number of Participants Who Answer Yes to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)"|LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||participants|||Number
2819905|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)|Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819906|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819907|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)|Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819908|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819909|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore|Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819910|NCT00384930|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2819911|NCT00384865|Secondary|Adverse Events|Please refer to the Adverse Event Tables for specific information|Measured at 6 months||||events|||Number
2819912|NCT00384865|Secondary|Time to Clinical Worsening Events (Number of Events)|Defined by the addition of new PAH therapies or dose increases in previously stable PAH therapy, hospitalization for right-sided heart failure, lung transplantation, atrial septostomy, and cardiovascular and all-cause death.|Measured at 6 months||||events|||Number
2819913|NCT00384865|Primary|Distance Walked in Six Minutes||Measured at 6 months||||meters||95% Confidence Interval|Least Squares Mean
2819914|NCT00384839|Secondary|Changes in Fetal Hemoglobin (HbF) With Time.|Time from baseline to maximal fetal hemoglobin (HbF).|Up to 1 year.|Patients with HbF measurements.|||weeks||Full Range|Median
2819915|NCT00384839|Secondary|1-year Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|Up to 1 year.|ITT population|||Probability of Survival at 1-year||95% Confidence Interval|Number
2819916|NCT00384839|Secondary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 1.5 year.|ITT population|||weeks||Full Range|Median
2819917|NCT00384839|Secondary|Objective Response Rate by Recist (ORR)|ORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Every 8 weeks for 1 year.|Only for patients with lesions evaluable by RECIST criteria at baseline.|||percentage of participants||95% Confidence Interval|Number
2819918|NCT00384839|Secondary|PSA Response Rate|Complete PSA Response defined as complete normalization of PSA maintained for at least 4 weeks, and partial PSA response defined as a decrease in PSA level of at least 50% from baseline level maintained for at least 4 weeks.|Every 8 weeks for 1 year.|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2819919|NCT00384839|Primary|Percentage of Patients With PSA Doubling Time >=3 Months.|To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time >3= months.|Until progression or up to a maximum of 12 cycles|Evaluable population|||% of patients with PSA-DT>= 3 months||95% Confidence Interval|Number
2819920|NCT00384813|Secondary|Brief Symptom Inventory (BSI)||4 months, 10 months|||||||
2819921|NCT00384813|Secondary|Parenting Stress Index - SF (PSI-SF)||4 months, 10 months|||||||
2819922|NCT00384813|Primary|Asthma Morbidity, as Determined by Number of Asthma Symptom Days, Number of School Days Missed Due to Asthma, and Number of Emergency Department Visits for Acute Asthma||4 months, 10 months|||||||
2819923|NCT00384813|Primary|Metered Dose Inhaler Checklist (MDIC)|Observational rating scale assessing MDI/spacer technique|4 months, 10 months|||||||
2820023|NCT00383721|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|"Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more~nebulized treatments/day of inhaled rescue medication. Moderate = treatment with~antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event."|Endpoint (26 weeks)|ITT population|||Participants|||Number
2819924|NCT00384813|Primary|Mean Score on the Family Asthma Management System Scale (FAMSS)|Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.|4 months from baseline||||units on a scale||Standard Error|Mean
2819925|NCT00384774|Secondary|Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)|PGI scale is a participant-rated instrument that measures participants own global impression of their illness severity. Participants were asked to mark the box that best describes their headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse.|2 hours post dose|All randomized participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2819926|NCT00384774|Secondary|Percentage of Participants Using Rescue Medication|Use of rescue medication up to 24 hours after initiation of study drug.|24 hours post dose|All randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2819927|NCT00384774|Secondary|Number of Participants With Clinical Disability|Clinical disability for each participant was assessed using the Clinical Disability Questionnaire (CDQ). Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.|2 hours post dose|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2819928|NCT00384774|Secondary|Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia|Number of participants with absence of nausea, vomiting, photophobia and phonophobia.|2 hours post dose|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2819929|NCT00384774|Secondary|Number of Participants With Sustained Pain Free|Sustained pain free was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.|2 to 24 hours post dose|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2819930|NCT00384774|Secondary|Number of Participants With Sustained Headache Response|Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the participant diary. Sustained headache response was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.|2 to 24 hours post dose|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2819931|NCT00384774|Secondary|Percentage of Participants Headache Free|Headache free is defined as a reduction in headache severity from moderate or severe at baseline to no headache pain at 10 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min, and 240 min after initiation of study drug.|10, 20, 40, 60 90, 120, 180 and 240 minutes post dose|All randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2819932|NCT00384774|Secondary|Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose|Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.|10, 20, 40, 60 90, 120, 180 and 240 minutes post dose|All randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2819933|NCT00384774|Primary|Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug|Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.|2 hours post dose|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2819934|NCT00384748|Primary|Physical Function as Measured by Telephone Version of FIM|The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task.|6-month||||units on a scale||Standard Deviation|Mean
2819935|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the second dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255||||Number of solicited general symptoms|||Number
2819936|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the first dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255||||adverse events|||Number
2819937|NCT00384670|Secondary|Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Geometric mean titers (GMT) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to JE vaccine antibody titers.|Approximately Day 225 and Day 255|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.|||titer||95% Confidence Interval|Geometric Mean
2819938|NCT00384670|Secondary|Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Percentage of individuals with ≥ 10 dilution (DIL) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to Japanese encephalitis (JE) vaccine antibody titers.|30 days after the second dose of JE vaccine|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.|||percentage of participants||95% Confidence Interval|Number
2819939|NCT00384670|Secondary|Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine|Number of solicited general symptoms within the 21-day follow-up of dengue dose 2 vaccine dose (total vaccinated cohort)|21 Days (0-20) After the Second Dose of Dengue Vaccine||||adverse events|||Number
2819940|NCT00384670|Secondary|Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine|Number of subjects with unsolicited symptoms classified by MedDRA Primary System Organ Class and Preferred Term, within 30 days after dengue vaccine (total vaccinated cohort)|30 days||||adverse events|||Number
2819941|NCT00384670|Primary|Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.|Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).|21 days||||adverse events|||Number
2819942|NCT00384449|Secondary|Incidence of Ocular and Non-ocular Adverse Events Evaluated Through Month 6.|No adverse events.|Monthly through Month 6||||adverse events|||Number
2819943|NCT00384449|Secondary|BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters.||Months 3,4,5 and 6|A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.|||letters|||Number
2819944|NCT00384449|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs|No adverse events.|Monthly through Month 6|A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.|||adverse events|||Number
2819945|NCT00384449|Primary|Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)||Monthly through Month 6|A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.|||adverse events|||Number
2819946|NCT00384449|Primary|Change in OCT Thickness.||Baseline and 6 months|A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.|||um|||Number
2819947|NCT00384397|Secondary|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination|Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.|0-7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Percentage of Participants|||Number
2819948|NCT00384397|Other Pre-specified|Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.||30 days post-Visit 2 Menactra®|Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2819949|NCT00384397|Other Pre-specified|Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-Visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
2819950|NCT00384397|Primary|Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
2819951|NCT00384332|Secondary|Change From Baseline Montgomery Asberg Depression Rating Scale|Montgomery Asberg Depression Rating Scale (MADRS) total score. Construct: Depression severity. Scores below represent mean change scores, endpoint minus baseline. Minimum total score: 0 (no depression). Maximum total score: 60 (severe depression). Lower (more negative) scores indicate a better outcome. There are no subscales.|10 weeks|Patients with bipolar disorder randomized to orally disintegrating versus regular olanzapine.|||units on a scale||Standard Deviation|Mean
2819952|NCT00384332|Primary|Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8|Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8|10 weeks||||kilograms||Standard Error|Mean
2819953|NCT00384293|Secondary|Change in Lipid Profile||after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed||||||
2819954|NCT00384293|Primary|Change in Mean Carotid Intima Media Thickness|change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.|after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed||||||
2819955|NCT00384241|Secondary|The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure|Stress induced systolic blood pressure (SBP) data generated from two previous studies was collected. In the previous studies, systolic blood pressures were measured before and after completing a video game challenge. Stress induced SBP is defined as delta SBP = stress SBP - baseline SBP.|baseline and 4 hours|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.|||mmHg||Standard Deviation|Mean
2819956|NCT00384241|Primary|Change in Urinary Sodium Excretion (UNaV)|The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.|Baseline and 4 hour|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.|||pg/ml||Standard Deviation|Mean
2820084|NCT00383448|Primary|Number of Patients With Donor Cell Engraftment|Donor Cell Engraftment is defined as the process of transplanted stem cells reproducing new cells.|Day 100|One patient was not evaluable due to an early death.|||Participants|||Count of Participants
2819957|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall|PACQLQ assesses the impact of the child's asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2819958|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score|PAQLQS is a disease specific instrument to assess the impact of asthma on the patient's quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2819959|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||percentage of days||Full Range|Median
2819960|NCT00384189|Secondary|Change in Use of Rescue Medications|The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.|||puffs/day||Standard Deviation|Mean
2819961|NCT00384189|Secondary|Change in Asthma Symptom Total Score|Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.|||score on a scale||Standard Deviation|Mean
2819962|NCT00384189|Secondary|Change From Baseline in Diurnal PEF Fluctuations|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||percent change||Standard Deviation|Mean
2819963|NCT00384189|Secondary|Change From Baseline in Evening PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.|||liters/minute||Standard Error|Least Squares Mean
2819964|NCT00384189|Secondary|Change From Baseline in Morning PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Weeks 1 thru 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||liters/minute||Standard Error|Least Squares Mean
2820024|NCT00383721|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly~average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population|||Participants|||Number
2819965|NCT00384189|Secondary|Change From Baseline in Lung Function Variable PEF by Spirometry|Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.|||liters/minute||Standard Error|Least Squares Mean
2819966|NCT00384189|Secondary|Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)|Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||liters||Standard Error|Least Squares Mean
2819967|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||percentage of days||Full Range|Median
2819968|NCT00384189|Secondary|Time to First Event of Lack of Efficacy (LOE) by Week 12|Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period.|12 weeks|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||Percent|||Number
2819969|NCT00384189|Primary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.|||liters/minute||Standard Error|Least Squares Mean
2819970|NCT00384176|Secondary|Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)|Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.|Baseline through to data cut-off||||Days||Inter-Quartile Range|Median
2819971|NCT00384176|Secondary|Percentage Change in Tumour Size|Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100|Baseline to Week 8|No statistical analyses were performed on the 30mg group. Patients had to have both a baseline and post-baseline (week 8) value to be included in the analysis. If patients did not have a week 8 assessment they were not included.|||Percentage change in tumour size||Standard Deviation|Mean
2819972|NCT00384176|Secondary|Duration of Response|Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.|Up until data cut-off date of 15/11/2007|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
2819973|NCT00384176|Secondary|Objective Response Rate|"Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:~CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs."|Up until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Participants|||Number
2819974|NCT00384176|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
2819975|NCT00384176|Primary|Progression Free Survival|Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.|||Months||Inter-Quartile Range|Median
2820535|NCT00380250|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF|||Scale score||Standard Deviation|Mean
2819976|NCT00384085|Secondary|Adjusted Hypoglycemic Event Rates (Event/Patient-year)|"Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study.~An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug)."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.|||event per patient year||Standard Error|Mean
2819977|NCT00384085|Secondary|Adjusted Incidence Rate of Hypoglycemia|"Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia.~A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event.~A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion.~Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock.~An event is included if the HE start date is within the treatment period."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.|||estimated percentage per patient||Standard Error|Mean
2819978|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl|"Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration.~A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms."|At week 60|Analysis was performed on the mITT population. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3, 9 from Lantus/Apidra-1 & 7 from Novolog Mix arms) were excluded from this analysis.|||percentage of participants|||Number
2819979|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)|Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders.|At week 60|Analysis was performed on the modified intent-to-treat population which consisted of all patients who were randomized & for whom there was a baseline observation & at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (9 for Lantus/Apidra-1 & 7 for Novolog Mix arms) were excluded from this analysis.|||percentage of participants|||Number
2819980|NCT00384085|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)|Absolute Change in HbA1c from Baseline to Week 60.|From baseline to week 60|Analysis was performed on the modified ITT (mITT) population which consisted of all patients who were randomized, and for whom there was a baseline observation and at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3 & 7 from Novolog Mix arms) were excluded from this analysis.|||percent HbA1c||Standard Error|Least Squares Mean
2819981|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on the Intent To Treat (ITT) population which consisted of all patients who were randomized, and for whom there was any post-baseline follow-up information. Patients from non-GCP compliant sites were included in this analysis. This analysis was performed to ensure that study results were not compromised.|||percentage of participants|||Number
2819982|NCT00384085|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population|Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol.|At week 60|Analysis was performed on the Per Protocol (PP) population which included randomized patients who had no major protocol violation and who had HbA1c recorded for both Baseline & Week 60. Patients from non-GCP compliant sites were, by population definition, excluded from this analysis.|||percent HbA1c||Standard Error|Least Squares Mean
2819983|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on Intent-To-Treat population which consisted of all patients who were randomized and for whom there was any post-baseline follow-up information. Patients from nonGCP compliant sites were excluded from this analysis. Additional analysis including those patients were completed to ensure that study results were not compromised.|||percentage of participants|||Number
2819984|NCT00384059|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N)= number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||titer||95% Confidence Interval|Geometric Mean
2819985|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.|During the 4-day period after each dose|Safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2819986|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)= number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2819987|NCT00384059|Primary|Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.|Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI.|one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2819988|NCT00384059|Primary|Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate igG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2819989|NCT00384059|Secondary|Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2819990|NCT00384059|Primary|Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||EU/mL||95% Confidence Interval|Geometric Mean
2819991|NCT00384059|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2819992|NCT00384059|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||titer||95% Confidence Interval|Geometric Mean
2819993|NCT00384059|Secondary|Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.|||Percentage of Participants||95% Confidence Interval|Number
2819994|NCT00384059|Secondary|Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.||one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.|||Percentage of Participants||95% Confidence Interval|Number
2819995|NCT00384059|Primary|Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.|One month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.|||Percentage of participants||95% Confidence Interval|Number
2819996|NCT00384033|Secondary|Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation|VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||mm||Standard Error|Mean
2819997|NCT00384033|Secondary|Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation|COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2819998|NCT00384033|Secondary|Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation|HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2819999|NCT00384033|Secondary|Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2820000|NCT00384033|Secondary|Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation|Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2820001|NCT00384033|Secondary|Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2820002|NCT00384033|Secondary|Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2820003|NCT00384033|Secondary|Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.|Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Participants|||Number
2820004|NCT00384033|Primary|Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.|Baseline and Week 8 or FOT|Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.|||Units on a Scale||Standard Error|Mean
2820005|NCT00383942|Primary|Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor|The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.|At time of delivery|No participants are included in this analysis because the trial was terminated prematurely.||||||
2820006|NCT00383786|Other Pre-specified|Able to Identify Biological Markers That Predict Response to Treatment.||10 weeks|||||||
2820536|NCT00380250|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF|||Scale score||Standard Deviation|Mean
2820007|NCT00383786|Primary|Changes in CAPS Scores.|"The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 B symptom, 3 C symptoms, and 2 D symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks."|Baseline, 8 weeks|20 patients randomized to drug were included in the primary analysis as 2 our of the 22 randomized were excluded because they did not receive a week 1 assessment. 19/25 randomized to placebo were included in the analysis after 6 were excluded due to not receiving week 1 assessments.|||scores on a scale||Standard Deviation|Mean
2820008|NCT00383760|Secondary|Objective Stable Disease Rate|Objective stable disease rate Using RECIST|Upto 3 years|Data was not collected||||||
2820009|NCT00383760|Secondary|Toxicity|Types of Gr 3 or greater adverse events that are atleast possibly related to study drug|All patients will be evaluable for toxicity from the time of their first treatment with E7389.||||Types of adverse event|||Number
2820010|NCT00383760|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|Data were not collected||||||
2820011|NCT00383760|Secondary|Time to Progression|Estimated using the Kaplan-Meier method.|At 1 year|Time to progression at 1 year not analyzed||||||
2820012|NCT00383760|Secondary|Time to Progression|"Estimated using the Kaplan-Meier method.~Median time to progression"|At 6 months||||months||95% Confidence Interval|Median
2820013|NCT00383760|Secondary|Median Time to Disease Progression|Estimated using the Kaplan-Meier method.|Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years||||months||95% Confidence Interval|Median
2820014|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 1 year||||participants|||Number
2820015|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 6 months||||percentage of participants||95% Confidence Interval|Number
2820016|NCT00383760|Secondary|Median Survival Time|Estimated using the Kaplan-Meier method.|Up to 3 years||||months||95% Confidence Interval|Median
2820017|NCT00383760|Secondary|Stable Disease Rate, Evaluated Using RECIST Criteria|Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
2820018|NCT00383760|Primary|Objective Response (Complete and Partial) Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 3 years||||participants|||Number
2820019|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard|The Grooved Pegboard (model 32025 Lafayette Instrument Company, Lafayette, IN, USA). In this test of lateralized psychomotor speed, participants had 45 s to place as many pegs as possible into grooves on a board using their dominant hand. The number of correctly placed pegs were recorded for each of the two trials.It was measured 3 hrs after application of the patch after CPT, Stroop and Letter number sequencing|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||number of pegs into grooves||Standard Deviation|Mean
2820020|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing|This measure of working memory and auditory attention was performed under two conditions. In the first condition, participants were read progressively longer lists of letters and numbers and instructed to repeat these exactly as given, without reordering. In the second condition, participants were read progressively longer lists of numbers and letters and instructed to re-order the list and give the numbers first in ascending order and then the letters in alphabetical order (WMS-III). The sum of the trial scores provided the item score and the sum of the item scores provided the total score.It was measured 3 hrs after application of the patch, after CPT and Stroop. The total score ranges from 0 to 21.Higher scores of Letter number sequencing means better working memory and auditory attention|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||units on a scale||Standard Deviation|Mean
2820021|NCT00383747|Secondary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop|This standard test of visual attention, processing speed and cognitive interference was performed, in which three cards (Stoelting Co., Wood Dale, IL, USA) were presented in order: the first card with color names, the second with colored patches of ink and the third with color namesprinted in incongruously colored ink. Participants were asked to read or name as many colors as possible in 45 s for each condition. The raw interference score was calculated by subtracting the predicted color-word score (calculated using raw word and color scores) from the observed raw color-word score. This value was converted to an interference T score by referring to a standardized table. A higher interference T score indicates better task performance with less interference. It was measured 3 hrs after application of the patch, after CPT|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||score||Standard Deviation|Mean
2820022|NCT00383747|Primary|Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version|The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch|Visit 1 and visit 2 (separated by an interval of 7-10 days)||||milliseconds||Standard Deviation|Mean
2820025|NCT00383721|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population|||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
2820026|NCT00383721|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|"SGRQ consisted of 76 items aggregated into 3 component scores: symptoms~(frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score ranged from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint was the last post-baseline non-missing result through the 26 week evaluation carried forward."|Baseline to Endpoint (26 weeks)|ITT population|||Score on a scale||Standard Deviation|Least Squares Mean
2820027|NCT00383721|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|ITT population|||Liters||Standard Deviation|Least Squares Mean
2820028|NCT00383721|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population|||Liters||Standard Deviation|Least Squares Mean
2820029|NCT00383708|Secondary|Number of Subjects With Putative Antibodies to Lanreotide and to Pegvisomant During the Co-administration Period|Presence of putative antibodies to lanreotide and antibodies to pegvisomant were assessed prior to IMP administration at V2, V4 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The number of subjects with putative antibodies to lanreotide and to pegvisomant during the co-administration period (Baseline up to V11) is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant).|||Number of subjects|||Number
2820030|NCT00383708|Secondary|Change From Baseline in Prothrombin Time (Expressed as a Percentage of Normal) During the Co-administration Period|Blood samples for clinical laboratory tests were taken at V1, V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). During the co-administration period, hepatic toxicity was assessed at each visit (V5 to V10) by measuring ALT, AST, alkaline phosphatase, GGT, prothrombin time and total bilirubin. Prothrombin time was expressed as a percentage of the time taken for a control blood sample to clot (designated as 100%) and the mean change from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||percentage of time||Standard Deviation|Mean
2820031|NCT00383708|Secondary|Change From Baseline in Total Bilirubin During the Co-administration Period|Blood samples for clinical laboratory tests were taken at V1, V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). During the co-administration period, hepatic toxicity was assessed at each visit (V5 to V10) by measuring ALT, AST, alkaline phosphatase, GGT, prothrombin time and total bilirubin. The change in mean total bilirubin from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||micromoles per litre||Standard Deviation|Mean
2820032|NCT00383708|Secondary|Change From Baseline in Liver Function Test Parameters During the Co-administration Period|Blood samples for clinical laboratory tests were taken at V1, V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). During the co-administration period, hepatic toxicity was assessed at each visit (V5 to V10) by measuring alanine amino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase, gamma glutamyl transferase (GGT), prothrombin time and total bilirubin. The change in mean ALT, AST, GGT and alkaline phosphatase from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in each individual analysis.|||IU/L||Standard Deviation|Mean
2820033|NCT00383708|Secondary|Change From Baseline in Mean Glycosylated Haemoglobin (HbA1C) During the Co-administration Period; Assessed in Non Diabetic and Diabetic Subjects|Glycosylated haemoglobin (HbA1C) was measured at V2, V3 and V11 (or in case of premature discontinuation, at the early withdrawal visit). The change in mean HbA1C in diabetic and non diabetic subjects from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis (56 overall for diabetic + non-diabetic subjects).|||percentage||Standard Deviation|Mean
2820062|NCT00383643|Primary|Assessment of Insomnia Severity Index|"Current self-report on Insomnia Severity Index at week 12 of treatment intervention. This is a seven-item questionnaire where the sum of the answers indicate the severity of insomnia. Total score categories:~0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)"|12 weeks|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
2820034|NCT00383708|Secondary|Change From Baseline in Mean Fasting Insulin / Glucose Ratio During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean fasting insulin / glucose ratio from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||ratio||Standard Deviation|Mean
2820035|NCT00383708|Secondary|Change From Baseline in Mean Fasting Glucose Concentration During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean fasting glucose concentration from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||mmol/L||Standard Deviation|Mean
2820036|NCT00383708|Secondary|Change From Baseline in Mean Fasting Insulin Concentration During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean fasting insulin concentration from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||picomoles per litre (pmol/L)||Standard Deviation|Mean
2820037|NCT00383708|Secondary|Change From Baseline in Mean Blood Glucose Maximum Concentration (Cmax) From Oral Glucose Tolerance Test (OGTT) During the Co-administration Period; Assessed in Non Diabetic Subjects|Glucose tolerance was only evaluated in non diabetic subjects. Glucose tolerance was assessed based on measurement of fasting blood glucose and insulin levels taken at V2 and OGTT performed at V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). A dose of 75 g oral glucose was given to subjects and blood samples then taken at 30, 60, 90 and 120 minutes after oral glucose to measure glucose, insulin and GH levels, and to evaluate the GH nadir level. The OGTT was performed after the assessment of IGF-1 and all safety laboratory tests, but before IMPs administration at V3. Glucose, insulin and GH levels were assessed before OGTT in fasting conditions and at the same time as IGF-1 assessment. The change in mean blood glucose Cmax (as determined from OGTT) from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Assessed in non diabetic subjects only (n = 38). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||millimoles per litre (mmol/L)||Standard Deviation|Mean
2820038|NCT00383708|Secondary|Change From Baseline in Mean Pituitary Tumour Size During the Co-administration Period|Pituitary tumour size was assessed by Magnetic Resonance Imaging at V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The two longest diameters of the pituitary tumour were to be measured. The change in mean pituitary tumour size from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||mm^3||Standard Deviation|Mean
2820039|NCT00383708|Secondary|Number of Subjects With Shift in Presence/Absence of Lithiasis and/or Sludge During Co-administration Period|A gallbladder ultrasound was performed at V2, V3, and V11 (or in case of premature study discontinuation, at the early withdrawal visit). Presence of lithiasis and sludge was recorded. Number of subjects who developed or resolved lithiasis and developed or resolved sludge, comparing Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant).|||participants|||Number
2820127|NCT00383162|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820040|NCT00383708|Secondary|Change From Baseline in Mean PR Interval, QRS Interval, QT Interval, RR Interval and QTcF During the Co-administration Period|Twelve-lead ECG recordings were performed at V2, V3 and V11. Sinus rhythm, heart rate, PR interval, RR interval, QRS interval and QT interval were measured and QTcF was calculated. The change in mean ECG parameter for PR interval, QRS interval, QT interval, RR interval and QTcF from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in each individual analysis.|||milliseconds (ms)||Standard Deviation|Mean
2820041|NCT00383708|Secondary|Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate During the Co-administration Period|Twelve-lead ECG recordings were performed at V2, V3 and V11. Sinus rhythm, heart rate, PR interval, RR interval, QRS interval and QT interval were measured and heart rate corrected QT interval using the Fridericia method (QTcF) was calculated. The change in ECG mean heart rate from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of IMP drug during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||bpm||Standard Deviation|Mean
2820042|NCT00383708|Secondary|Change From Baseline in Mean Supine Heart Rate During the Co-administration Period|Heart rate (supine after resting for 3 minutes) was recorded at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean heart rate from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||beats per minute (bpm)||Standard Deviation|Mean
2820043|NCT00383708|Secondary|Change From Baseline in Mean Supine Systolic and Diastolic Blood Pressure (BP) During the Co-administration Period|Blood pressure (supine after resting for 3 minutes) was recorded at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean BP (systolic and diastolic) from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||millimetres mercury (mmHg)||Standard Deviation|Mean
2820044|NCT00383708|Secondary|Change From Baseline in Mean Weight From Baseline During the Co-administration Period|Weight was recorded at V2, V3 and V11 (or in case of premature study discontinuation, at the early withdrawal visit). The change in mean weight from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The Safety population was defined as all subjects who received at least one dose of each IMP during the co-administration period (i.e. one dose of lanreotide Autogel 120 mg and one dose of pegvisomant). Only evaluable subjects with an assessment at the specified visit were included in the analysis.|||kilograms (kg)||Standard Deviation|Mean
2820045|NCT00383708|Other Pre-specified|Change From Baseline in Prolactin Levels During the Co-administration Period|Serum samples were assessed for prolactin levels at V1, V2, V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). The change in mean prolactin levels from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||micrograms per litre (mcg/L)||Standard Deviation|Mean
2820046|NCT00383708|Other Pre-specified|Change From Baseline in Acid Labile Subunit Levels From Baseline During the Co-administration Period|Serum samples were assessed for acid labile subunit levels at V1, V2, V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). The change in mean acid labile subunit levels from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||milli IU per millilitre (mIU/mL)||Standard Deviation|Mean
2820047|NCT00383708|Other Pre-specified|Change From Baseline in Serum GH Binding Protein Levels During the Co-administration Period|Serum samples were assessed for GH binding protein levels at V1, V2, V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). The change in mean serum GH binding protein from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||pmol/L||Standard Deviation|Mean
2820048|NCT00383708|Other Pre-specified|Percentage of Subjects With Serum GH Levels Lesser or Equal to 2.5 ng/mL During the Study|Serum samples were assessed for GH levels at the same timepoints as the IGF-1 sample at V1 and V2 and during the OGTT (non diabetic subjects only) at V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). Five samples were taken over 2 hours in order to assess GH nadir and confirm the subject's eligibility before entering the co-administration period. For diabetic subjects, the OGTT was replaced by a measurement of GH level on a blood sample taken at the same time as IGF-1 at V3 and V11 (or at the early withdrawal visit). The percentage of subjects with serum GH levels ≤ 2.5 ng/mL at Baseline, V11 and LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||percentage of subjects|||Number
2820049|NCT00383708|Other Pre-specified|Change From Baseline in Serum GH Levels During the Co-administration Period|Serum samples were assessed for GH levels at the same timepoints as the IGF-1 sample at V1 and V2 and during the OGTT (non diabetic subjects only) at V3 and V11 (or at the early withdrawal visit in case of premature discontinuation). Five samples were taken over 2 hours in order to assess GH nadir and confirm the subject's eligibility before entering the co-administration period. For diabetic subjects, the OGTT was replaced by a measurement of GH level on a blood sample taken at the same time as IGF-1 at V3 and V11 (or at the early withdrawal visit). The change in mean serum GH levels from Baseline to V11 and to LVA is presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
2820050|NCT00383708|Secondary|Correlation Between the Changes in ACROQoL Assessments With the Corresponding Changes in Z-score of IGF-1 Levels Over the Run-in Period and Co-administration Period|The correlation between the changes in ACROQoL (expressed as standardised scores and undertaken for global score, physical and psychological dimension scores and appearance and personal relationships sub-dimension scores) over the run-in period (V3 minus V2) and co-administration period (V11 and LVA minus V3) with the corresponding changes in z-score for the IGF-1 level is presented. A decrease in IGF-1 z-score represents an improvement and an increase in ACROQoL score represents an improvement. Spearman's rank correlation (r) values are presented for change from V2 to V3 (Baseline) and from Baseline to V11/LVA for each of the specified ACROQoL categories. Corr = Correlation; Dim = Dimension; Relnship = Relationship.|At V2 (Day 1; Run-in), V3 (Week 12; Baseline) and V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint.|||correlation value|||Number
2820051|NCT00383708|Secondary|Change From Baseline in Acromegaly Quality of Life (ACROQoL) Assessments During the Co-administration Period|The ACROQoL is a health-related quality of life (QoL) questionnaire for patients with acromegaly consisting of 22 items measured on a 5-point Likert-type scale that assesses frequency of occurrence (always to never) or degree of agreement (completely agree to completely disagree) with the statements. The ACROQoL consists of questions that evaluate physical (8 items) and psychological aspects related to appearance and personal relations (7 items each). Answers are transformed to a percentage value, where 100 is the maximal (best) and 0 the minimum (worse) score depicting self-perceived quality QoL. An increase in ACROQoL score is associated with an improved QoL. The change in ACROQoL global score, physical and psychological dimension scores and appearance and personal relationships sub-dimension scores from Baseline to V11 and to LVA are presented. Relnship = Relationship; Dim = Dimension.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||units on a scale||Standard Deviation|Mean
2820052|NCT00383708|Secondary|Change From Baseline in Acromegaly Symptoms During the Co-administration Period|Acromegaly symptoms, including arthralgia, excessive perspiration, fatigue, headache and soft tissue swelling were assessed with scores ranging from 0 (no symptoms) to 8 (severe, incapacitating symptoms). Symptoms were assessed by the subject in paper format before any other procedure planned during the visit. The change in acromegaly symptoms from Baseline to V11 and to LVA are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||units on a scale||Standard Deviation|Mean
2820053|NCT00383708|Secondary|Change From Baseline in Serum IGF-1 Levels (Expressed as Z-scores) During the Co-administration Period|The change in serum IGF-1 levels, expressed as z-scores calculated using the age and sex specific mean and standard deviation [SD] values from Baseline to V11 and to LVA are presented. A z-score between +/- 2 indicates a normal IGF-1 concentration.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||z-score||Standard Deviation|Mean
2820054|NCT00383708|Secondary|Percentage of Subjects With Normalised (Age and Sex Adjusted) IGF-1 at Each Assessment|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. The percentage of subjects with a normalised (age and sex adjusted) IGF-1 level is presented. The denominator used to calculate the percentages was the number of ITT population subjects with an assessment at the visit. In addition to the data for each individual visit, the last value available (LVA) data is also presented. None of the ITT population subjects had serum IGF-1 normalised at V3, consistent with the criterion to continue in the study and be treated in the co-administration period.|V1 (Screening) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects with assessments at each specified visit included in analysis.|||percentage of subjects|||Number
2820077|NCT00383552|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||liters * hours||Standard Deviation|Least Squares Mean
2820055|NCT00383708|Secondary|Percentage of Subjects With a Normalised (Age and Sex Adjusted) IGF-1 Level at Any Time During the Co-administration Period|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at least once during the co-administration period, summarised by 'while taking the final dose during co-administration' and 'at any time during co-administration' are presented.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint.|||percentage of subjects|||Number
2820056|NCT00383708|Primary|Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by diabetic status are presented. The denominator used to calculate percentages was the number of subjects in each subgroup (diabetic and non diabetic). The LOCF approach was used to replace missing IGF-1 values.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects within each of the two subgroups analysed for each category.|||percentage of subjects|||Number
2820057|NCT00383708|Primary|Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Previous Treatment and by Final Dose of Pegvisomant|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at V1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to IMP administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period, summarised by previous treatment and by final pegvisomant dose are presented. The denominator used to calculate percentages was the number of subjects in each subgroup, comprising previous treatment with pegvisomant, lanreotide Autogel and octreotide long acting repeatable (LAR) and final pegvisomant dose as either 40 mg, 60 mg or 80 mg once a week or 40 mg or 60 mg twice per week. The LOCF approach was used to replace missing IGF-1 values.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint. Only evaluable subjects within each individual subgroup analysed for each category.|||percentage of subjects|||Number
2820058|NCT00383708|Primary|Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period|Serum IGF-1 is a well known and validated marker of acromegaly. IGF-1 assessments were performed at Visit (V) 1, V2, V3, V5, V7, V9 and V11 (or in case of premature study discontinuation, at the early withdrawal visit) and were based on a single serum sample taken in fasting conditions, prior to investigational medicinal product (IMP) administration. Percentage of subjects with a normalised (age and sex adjusted) IGF-1 level at the end of the co-administration period are presented. The last observation carried forward (LOCF) was used to replace missing IGF-1 values.|V3 (Week 12; Baseline) up to V11 (Week 44)|The ITT population was defined as all co-administered subjects (treated with at least one dose of each of the two IMPs within the co-administration period) having at least one baseline and at least one post-baseline assessment of the primary efficacy endpoint.|||percentage of subjects|||Number
2820059|NCT00383643|Primary|Assessment of Sleepiness|Current self-report on Epworth Sleepiness Scale (ESS) at week 12 of intervention. This measure consists of 8 scenarios in which the participant is asked to assess how likely s/he is to fall asleep. Scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. Responses are summed for a total score ranging from 0 to 24. The higher the score, the greater the self-reported sleepiness. Scores of 9 and below are considered in the normal range.|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
2820060|NCT00383643|Primary|Assessment of Fatigue|Current self-report on Profile of Mood State -- Fatigue (POMS-F) at week 12 of intervention. This subscale of the POMS consists of 7 items each scored on a scale of 0 (not at all) to 4 (extremely) which are summed to provide a composite score of fatigue. The range is 0 to 28 for this subscale. Higher scores indicate more fatigue.|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
2820061|NCT00383643|Primary|Assessment of Pittsburgh Sleep Quality Index (PSQI)|"Current self-report on Pittsburgh Sleep Quality Index (PSQI) at week 12 of intervention. Consisting of 19 items, the PSQI measures several different aspects of sleep which can be combined into one global score.~Each item measure is scored on a scale of 0 to 3 where 3 is the extreme negative. The composite PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Based on this questionnaire, a composite score of 5 or greater is indicative of poor sleep quality."|One month|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
2820078|NCT00383500|Primary|Incidence of Lymphedema (Newly-developing)|Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.|3 years of semi-annual follow-up||||participants|||Number
2820584|NCT00379912|Secondary|BclXL Expression||Six months|Analysis of BclXL expression was undertaken irrespective of arm assignment and categorized between responsers and non-responders|||percentage L27 mRNA||Standard Error|Mean
2820063|NCT00383643|Primary|Assessment of Clinical Global Impression-change.|Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression - Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.|Baseline to week 12|All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.|||units on a scale||Standard Deviation|Mean
2820064|NCT00383630|Secondary|Number of Patients Who Completed a Six Minute Walk|"6 Minute walk as tolerated at 15 minutes following initiation of hand pumping.~Due to poor enrollment, results was not analyzed."|Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant|The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.||||||
2820065|NCT00383630|Secondary|Prevalence of Normal Echocardiographic Assessments|"Echocardiographic assessments of myocardial size and function by transthoracic echocardiography with the LVAD at full support, and as tolerated at 1, 5, 10 and 15 minutes following initiation of hand pumping.~Due to poor enrollment, data was not analyzed."|Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant|The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.||||||
2820066|NCT00383630|Primary|Duration of Time (Minutes) a Patient is Able to Tolerate Wean|This defines the functional status. Due to poor enrollment, data was not analyzed.|Measured 90 days post-intervention|The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.||||||
2820067|NCT00383565|Secondary|Median Overall Survival|Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.|5 Years||||months||Full Range|Median
2820068|NCT00383565|Secondary|Median Progression Free-survival (PFS)|Time to disease progression is defined as the time from registration to documentation of disease progression.|2 Years||||months||Full Range|Median
2820069|NCT00383565|Primary|Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment|International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.|24 weeks (6 courses of 4 week cycles)||||participants|||Number
2820070|NCT00383552|Primary|Number of Participants With at Least One Severe Asthma Exacerbation at Week 26|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Week 26||||participants|||Number
2820071|NCT00383552|Secondary|AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||liters * hours||Standard Deviation|Least Squares Mean
2820072|NCT00383552|Secondary|Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12|Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||liters||Standard Deviation|Least Squares Mean
2820073|NCT00383552|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA)|Baseline is the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Endpoint|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||Proportion of Nights||Standard Deviation|Least Squares Mean
2820074|NCT00383552|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||units on a scale||Standard Deviation|Least Squares Mean
2820075|NCT00383552|Primary|Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Across the 26 week treatment period|Medians for time-to-event outcomes are estimated for those who had events.|||Days||Inter-Quartile Range|Median
2820076|NCT00383552|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).|||units on a scale||Standard Deviation|Least Squares Mean
2820085|NCT00383435|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.|Endpoint (26 weeks)|ITT population|||Participants|||Number
2820086|NCT00383435|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or~treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population|||Participants|||Number
2820087|NCT00383435|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population.|||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
2820088|NCT00383435|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.|Baseline to Endpoint (26 weeks)|ITT population|||Score on a scale||Standard Deviation|Least Squares Mean
2820089|NCT00383435|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|"Endpoint was the last post-baseline non-missing result through Week 13 carried~forward."|Baseline to Endpoint (13 weeks)|ITT population|||Liters||Standard Deviation|Least Squares Mean
2820090|NCT00383435|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population|||Liters||Standard Deviation|Least Squares Mean
2820091|NCT00383331|Secondary|Overall Survival|Survival time is defined as the time from date of randomization to death due to any cause.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
2820092|NCT00383331|Secondary|Time to Treatment Failure|Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
2820093|NCT00383331|Secondary|Duration of Response|Duration of response was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
2820094|NCT00383331|Secondary|Time to Progressive Disease|Time to progressive disease not analyzed because trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
2820095|NCT00383331|Secondary|Progression Free Survival|baseline to measured progressive disease|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||months||95% Confidence Interval|Median
2820096|NCT00383331|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up||||participants|||Number
2820097|NCT00383292|Secondary|Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score|FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.|Baseline to Study Completion (up to 60 Months)|All participants who received at least one dose of study drug and had baseline and post baseline FACT-G data. FACT-G analysis was performed on combined arms per protocol.|||Units on a Scale||Standard Deviation|Mean
2820098|NCT00383292|Secondary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events)|Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.|Baseline to Study Completion (up to 60 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2820099|NCT00383292|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 6, Tasisulam Target Cmax 360 µg/mL = 5, Albumin-Tailored Dose = 5.|||Months||95% Confidence Interval|Median
2820100|NCT00383292|Secondary|Duration of Overall Objective Response|The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.|Date of Response to Date of Measured PD (up to 1 Year)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 1, Tasisulam Target Cmax 360 µg/mL = 1, Albumin-Tailored Dose = 0.|||Months||95% Confidence Interval|Median
2820101|NCT00383292|Secondary|Overall Survival (OS) Time|OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.|Baseline to Death from Any Cause (up to 42 Months)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 25, Tasisulam Target Cmax 360 µg/mL = 17, Albumin-Tailored Dose = 17.|||Months||95% Confidence Interval|Median
2820102|NCT00383292|Secondary|Pharmacokinetics: Plasma Clearance Rate of Tasisulam||Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion|All participants who received at least one dose of study drug and had evaluable PK data. PK analysis were performed on combined arms for total drug per protocol.|||Liters/hour (L/h)||Standard Error|Geometric Mean
2820103|NCT00383292|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.|Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)|All participants who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
2820104|NCT00383292|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)|All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 10, Tasisulam Target Cmax 360 µg/mL = 8, Albumin-Tailored Dose = 8.|||Months||95% Confidence Interval|Median
2820105|NCT00383292|Primary|Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.|Baseline to Measured Progressive Disease (up to 60 Months)|All participants who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
2820106|NCT00383266|Secondary|Overall Survival (OS)|OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.|Until patient's death (median follow-up 293 days -- range (63-632 days))||||months||95% Confidence Interval|Median
2820107|NCT00383266|Secondary|Overall Survival Rate||2 years||||percentage of participants|||Number
2820108|NCT00383266|Secondary|Toxicities||30 days following completion of treatment (maximum number of cycles = 6)||||participants|||Number
2820109|NCT00383266|Secondary|Overall Survival Rate||1 year||||percentage of participants|||Number
2820110|NCT00383266|Secondary|Time to Disease Progression|-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Until patient progresses (median follow-up 293 days -- range (63-632 days)||||months||95% Confidence Interval|Median
2820111|NCT00383266|Primary|Overall Response Rate (ORR)|"Overall response rate = complete response (CR) + partial response (PR) using RECIST.~CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level~PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)||||percentage of participants|||Number
2820128|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820112|NCT00383240|Other Pre-specified|Number of Participants With at Least One Severe Asthma Exacerbation|"A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period:~A decrease in FEV1 below the Treatment Period stability limit at any visit,~A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days,~An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication."|Baseline to Week 26|All Randomized Subjects|||participants|||Number
2820113|NCT00383240|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)|Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.|Baseline to Endpoint|ITT population from the entire 26-week treatment period|||Ratio||Standard Deviation|Least Squares Mean
2820114|NCT00383240|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).|Baseline to week 26|ITT population with non-missing post-baseline ACQ result|||units on a scale||Standard Deviation|Least Squares Mean
2820115|NCT00383240|Primary|Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F|This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)|26-week Treatment Period|All Randomized Subjects|||days||Inter-Quartile Range|Median
2820116|NCT00383240|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.|Baseline to Week 26|ITT population with non-missing post-baseline AQLQ result|||units on a scale||Standard Deviation|Least Squares Mean
2820117|NCT00383240|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF||Baseline to Endpoint (12 weeks)|Intent to Treat (ITT) population|||liters x hours||Standard Deviation|Least Squares Mean
2820118|NCT00383162|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose. Placebo-23 subjects and Sumatriptan/Naproxen Sodium 54 subjects|||Participants|||Number
2820119|NCT00383162|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|"Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment.Complete pain/symptom-free was defined as migraine-free, neck pain-free, and sinus pain free."|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820120|NCT00383162|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820121|NCT00383162|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820122|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820123|NCT00383162|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820124|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820125|NCT00383162|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820126|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820166|NCT00383084|Primary|Ambulatory Fatigue, Higher Values Indicate Greater Fatigue|0-100 fatigue ratings, higher scores indicative of greater levels of fatigue|Baseline and after 12-weeks||||units on a scale||Standard Deviation|Mean
2820129|NCT00383162|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820130|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820131|NCT00383162|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820132|NCT00383162|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820133|NCT00383162|Secondary|Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|1/2, 1, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820134|NCT00383162|Secondary|Rescue Medication Used up to 24 Hours Post-dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|Dosing to 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820135|NCT00383162|Secondary|Pain-Free Assessment at 2 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820136|NCT00383162|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.|||Participants|||Number
2820137|NCT00383149|Secondary|Change From Baseline in FHSI-8 Total Score by Time-point|The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.|Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.||||||
2820138|NCT00383149|Secondary|Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression|EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.|Baseline|Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.||||||
2820139|NCT00383149|Secondary|Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption|Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.|From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.||||||
2820140|NCT00383149|Secondary|Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available|||participants|||Number
2820141|NCT00383149|Secondary|Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.|||participants|||Number
2820142|NCT00383149|Secondary|Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.|||participants|||Number
2820143|NCT00383149|Secondary|Median Time to Response|Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.|Response-evaluable participants whose best response was PR or CR.|||weeks||Full Range|Median
2820144|NCT00383149|Secondary|Median Duration of Response|Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).|Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.|||months||95% Confidence Interval|Median
2820145|NCT00383149|Secondary|Median Overall Survival Time|Overall survival time was defined as the time in months from the first dosing date to the date of death.|From the first dosing date until death (last reported death was 21 months after first dose).|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.|||months||95% Confidence Interval|Median
2820146|NCT00383149|Secondary|Median Progression Free Survival Time|Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.|||months||95% Confidence Interval|Median
2820147|NCT00383149|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2820148|NCT00383149|Secondary|Best Overall Tumor Response|Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.|||participants|||Number
2820149|NCT00383149|Primary|Percentage of Participants Surviving at 6 Months|The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.|From time of first dose of study drug through 6 months|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.|||percentage of participants||95% Confidence Interval|Number
2820167|NCT00383084|Primary|Ambulatory Pain (Higher Values Indicate Greater Pain)|0 to 100 pain rating, higher numbers indicate greater pain|Baseline and after 12-weeks||||units on a scale||Standard Deviation|Mean
2820150|NCT00383123|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)|"SAE: any untoward medical occurrence that~resulted in death,~was life-threatening,~required hospitalization or prolongation of existing hospitalization,~resulted in disability/incapacity, or~was a congenital anomaly/birth defect in the offspring of a study subject.~Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders."|Up to 6 months after vaccination||||Participants|||Count of Participants
2820151|NCT00383123|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination."|Within 28 days following vaccination||||Participants|||Count of Participants
2820152|NCT00383123|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.~Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination."|During a 4-day follow-up period after each vaccination|"Analysis was performed on vaccinated subjects with available data.~Pain, redness, swelling and fever were assessed in all age cohorts.~Drowsiness, irritability and loss of appetite were assessed in the 6 months to < 5 years cohort only.~Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to < 18 years cohort only."|||Participants|||Count of Participants
2820153|NCT00383123|Secondary|Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer|Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to < 5 years and with a baseline titre < 1:40 were analysed for this Outcome Measure.|||Participants|||Count of Participants
2820154|NCT00383123|Secondary|Number of Seroprotected Subjects|Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|Before (PRE) and 21 or 28 days after (POST) the last vaccine dose|As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom results were available.|||Participants|||Count of Participants
2820155|NCT00383123|Primary|Number of Subjects Reporting Rare Serious Events|"Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:~resulted in death,~was life-threatening,~required hospitalization or prolongation of existing hospitalization,~resulted in disability/incapacity, or~was a congenital anomaly/birth defect in the offspring of a study subject."|Up to 6 months after vaccination||||Participants|||Count of Participants
2820156|NCT00383123|Primary|Number of Seroconverted Subjects|"Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Data are presented for all 3 viral strains comprised in the vaccine."|21 or 28 days after last vaccine dose|As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom post-vaccination results were available.|||Participants|||Count of Participants
2820157|NCT00383123|Primary|Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies|GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to < 5 years).|||Titer||95% Confidence Interval|Geometric Mean
2820158|NCT00383110|Secondary|LDL-cholesterol||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||mg/dL||Standard Deviation|Mean
2820159|NCT00383110|Secondary|Diastolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||mmHg||Standard Deviation|Mean
2820160|NCT00383110|Secondary|Systolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||mmHg||Standard Deviation|Mean
2820161|NCT00383110|Primary|Health Care System Distrust Scale|Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.|12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.|||units on a scale||Standard Deviation|Mean
2820162|NCT00383110|Secondary|Hemoglobin A1c||12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.|||% HbA1c||Standard Deviation|Mean
2820163|NCT00383110|Primary|General Trust in Physicians Scale (GTIPS)|The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.|12 months following enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.|||units on a scale||Standard Deviation|Mean
2820164|NCT00383084|Secondary|Functional Capacity (Higher Scores Indicative of Poorer Functioning)|Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100|Baseline and after 12-weeks||||units on a scale||Standard Deviation|Mean
2820165|NCT00383084|Secondary|Number of Tender Points on the Body|Number of tender points on physical examination (maximum number is 18)|Baseline and after 12-weeks||||tender points||Standard Deviation|Mean
2820169|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
2820170|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
2820171|NCT00383019|Secondary|Number of Subjects With an IOP of <=18 mmHg at Week 8|Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
2820172|NCT00383019|Secondary|Number of Subjects With an IOP of <=17 mmHg at Week 8|Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
2820173|NCT00383019|Secondary|Number of Subjects With an IOP of <=16 mmHg at Week 8|Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
2820174|NCT00383019|Secondary|Number of Subjects With an IOP of <=15 mmHg at Week 8|Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||participants|||Number
2820175|NCT00383019|Secondary|Percent Change of IOP From Baseline to Week 8|Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.|||percent change||95% Confidence Interval|Least Squares Mean
2820176|NCT00383019|Secondary|Change of IOP From Baseline to Week 4|Value at Week 4 minus value at baseline|Baseline to Week 4|ITT|||mmHg||95% Confidence Interval|Least Squares Mean
2820177|NCT00383019|Primary|Change of Intraocular Pressure (IOP) From Baseline to Week 8|Value at Week 8 minus value at baseline|Baseline to Week 8|The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4.|||mmHg||95% Confidence Interval|Least Squares Mean
2820178|NCT00382993|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose.|||Participants|||Number
2820179|NCT00382993|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|"Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. Complete pain/symptom-free was defined as migraine-free, neck pain-free, and sinus pain free."|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820180|NCT00382993|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose||||Participants|||Number
2820181|NCT00382993|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820182|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
2820183|NCT00382993|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820184|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
2820185|NCT00382993|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820186|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
2820187|NCT00382993|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820188|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
2820189|NCT00382993|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820190|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose||||Participants|||Number
2820191|NCT00382993|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820192|NCT00382993|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose||||Participants|||Number
2820193|NCT00382993|Secondary|Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|0.5, 1, 4, and 8 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820194|NCT00382993|Secondary|Rescue Medication Use During 0 - 24 Hours Post-Dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|0-24 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820195|NCT00382993|Secondary|Migraine Headache Pain Free at 2 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820196|NCT00382993|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 Hours Post-Dose|ITT (Intent-to-Treat) Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.|||Participants|||Number
2820197|NCT00382967|Secondary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.|The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism|||Number of changes in clinical management|||Number
2820198|NCT00382967|Primary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)||||Number of changes in clinical management|||Number
2820199|NCT00382928|Secondary|Cerebral Performance at Discharge|"Cerebral Performance Categories/CPC scale:~CPC 1: Good cerebral performance - conscious, alert, able to work, might have mild neurologic or psychological deficit.~CPC 2: Moderate cerebral disability - conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.~CPC 3: Severe cerebral disability - conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.~CPC 4: Coma or vegetative state - any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.~CPC 5: Brain death - apnea, areflexia, electroencephalogram (EEG) silence, etc."|At discharge|Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.|||units on a scale: CPC 1|||Number
2820200|NCT00382928|Secondary|Survival to Discharge||At discharge||||participants|||Number
2820201|NCT00382928|Secondary|Frequency of Abnormal Rhythms Monitored by the AECD||During the duration of hospital admission on the telemetry ward.|Only the AECD+Standard of Care Group was monitored in this portion of the study.|||participants|||Number
2820202|NCT00382928|Primary|Number of Participants Without Defibrillation|Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.|10 minutes|"There was only one patient in the Intervention group who received defibrillation.~No patients had CPR or defibrillation in the standard of care group."|||participants|||Number
2820203|NCT00382863|Secondary|Days Alive Out of Hospital|Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.|||days||Full Range|Median
2820204|NCT00382863|Secondary|Serious Adverse Events - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events|12 months|Population is intent to treat.|||participants|||Number
2820207|NCT00382863|Secondary|All-Cause Hospitalization|Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.|||participants|||Number
2820208|NCT00382863|Secondary|Heart Failure Hospitalization|Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.|12 months|Population is intent to treat.|||participants|||Number
2820209|NCT00382863|Secondary|Heart Failure Death - Actuarial Analysis|Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure|12 months|Population is intent to treat.|||participants|||Number
2820210|NCT00382863|Secondary|Heart Failure Death|Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure|12 months|Population is intent to treat.|||participants|||Number
2820211|NCT00382863|Secondary|Technical Success (Number of Treatment Arm Participants Successfully Implanted)|"Technical success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis."|1 day|Population is as treated, treatment only.|||participants|||Number
2820212|NCT00382863|Secondary|Change in Left Ventricular End Systolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||centimeters||Full Range|Median
2820213|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||centimeters||Full Range|Median
2820214|NCT00382863|Secondary|Change in Ejection Fraction|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat.|||percent||Full Range|Median
2820215|NCT00382863|Secondary|Change in Left Ventricular End Systolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||milliliters||Full Range|Median
2820216|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||milliliters||Full Range|Median
2820217|NCT00382863|Secondary|Heart Failure Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.|||participants|||Number
2820218|NCT00382863|Secondary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 12 months|Population is intent to treat.|||participants|||Number
2820219|NCT00382863|Secondary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 12 months was at least 45 meters more than at baseline."|baseline to 12 Months|Population is intent to treat|||participants|||Number
2820220|NCT00382863|Secondary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline."|baseline to 12 months|Population is intent to treat.|||participants|||Number
2820221|NCT00382863|Secondary|Change in Left Ventricular Mass|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.|||grams||Full Range|Median
2820222|NCT00382863|Secondary|Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat|||score on a scale||Standard Deviation|Mean
2820223|NCT00382863|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remained the same as baseline. Improved means the participant's functional class improved (became lower in number) by at least one class. Worsened means the participant's functional class deteriorated (became higher in number) by at least one class."|baseline to 6 months|Population is intent to treat.|||participants|||Number
2820224|NCT00382863|Primary|Number of Participant Deaths|Total number of participants who died within 12 months of enrollment into the trial.|12 months|The population is intent to treat.|||participants|||Number
2820225|NCT00382863|Primary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 6 months|The population is intent to treat.|||participants|||Number
2820226|NCT00382863|Primary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 6 months was at least 45 meters more than at baseline."|Baseline to 6 months|The population is intent to treat.|||participants|||Number
2820227|NCT00382863|Primary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline."|Baseline to 6 months|The population is intent to treat.|||participants|||Number
2820228|NCT00382824|Secondary|Tolerability of Coenzyme Q10|"The tolerability of Coenzyme Q10 as determined by the number of subjects who complete the study on their original treatment assignment, and~The tolerability of Coenzyme Q10 as determined by the number of subjects completing the study."|12 months||||Participants|||Number
2820229|NCT00382824|Secondary|Safety Profile of Coenzyme Q10|The safety Profile of Coenzyme Q10 as determined by the analysis of the frequency and severity of the adverse event data, changes in the vital signs, electrocardiograms and clinical laboratory values, recorded over the course of the trial.|12 months||||Adverse Events|||Number
2820230|NCT00382824|Secondary|Quality of Life Questionnaires: Parkinson's Disease Questionnaire - 39 [PDQ-39], Short Form-36 [SF-36]|"Parkinson's Disease Questionnaire - 39 (PDQ-39): 39 Items. 8 subscales: mobility, activities of daily living, emotional well-being, stigma, social support , cognitions, communication, bodily discomfort. Subjects indicate never (0 pts), occasionally (1 pts), sometimes (2pts), often (3pts), or always/cannot do at all (4pts) for each item in each section. The sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Range of scores for each dimension: 0-100. The sum of dimension total scores are divided by 8 to calculate the Parkinson's Disease Severity Index. Range of total score for the Parkinsons' Disease Severity Index: 0-100. Lower scores indicate better quality of life.~Short Form-36 (SF-36): 36 items 8 subscales: (2) General Health Sections, Limitations of Activities, Physical Health Problems, Emotional Health Problems, Pain, (2) Social Activities sections, and Energy and Emotions. Each qu"|12 months||||units on a scale||Standard Deviation|Mean
2820231|NCT00382824|Secondary|Efficacy of Coenzyme Q10 (Mini-Mental State Examination [MMSE] and Activities of Daily Living [ADL] Scales)|"Efficacy of Coenzyme Q10 measured by change in intellectual function (the Mini-Mental State Examination [MMSE]) and Activities of Daily Living (ADL) scores.~MMSE: 30 point scale with 5 subsections (Total Score Range: minimum score = 0, maximum = 30): Orientation (max=10 pts, min=0 pts), Registration (max=3 pts, min=0 pts), Attention & Calculation (max=5pts, min=0 pts), Recall (max=3 pts, min= 0 pts), Language & Praxis (max=9 pts, min=0 pts). Lower scores indicate greater impairment. Scores <24 are considered abnormal.~Activities of Daily Living scores:~The UPDRS part II is used to assess subject's degree in which they can perform their Activities of Daily Living. Part II of the UPDRS rates subjects on a 0-4 scale, with 0 being Normal and 4 being Severe Impairment, for each respective item. For each item, the reported score is divided by the maximum total score for that item and multiplied by 100 to give a 0-100 scale range. Higher scores indicate greater impairment."|12 months||||units on a scale||Standard Deviation|Mean
2820232|NCT00382824|Primary|Efficacy of Coenzyme Q10 (Unified Parkinson's Disease Rating Scale [UPDRS] AND Progressive Supranuclear Palsy Rating Scale [PSPRS])|"Unified Parkinson's Disease Rating Scale [UPDRS]: Higher scores indicate a higher degree of impairment The total score is calculated by summing the subscores. Total scores range from 0 (normal) to 166 (severely impaired) Part I [Mentation, Behavior, & Mood] Scale: 0-16 Part II [Activities of Daily Living, Both ON & OFF] Scale:0-52 Part III [Motor Examination] Scale: 0-56 Part IV [Complications of Therapy] Scale: 0-34 Part V [Modified Hoehn & Yahr Staging] Scale: 0-8 Part VI [Schwab & England Activities of Daily Living Scale] Scale: 0 - 100%~Progressive Supranuclear Palsy Rating Scale [PSPRS] - Total Scale ranges from 0 (normal) to 128 (severely impaired) Section 1 [History] Scale: 0-31 Section 2 [Mentation] Scale: 0-20 Section 3 [Bulbar] Scale: 0-10 Section 4 [Ocular Motor] Scale: 0-20 Section 5 [Limb Motor] Scale: 0-22 Section 6 [Gait and midline] Scale: 0-25"|12 months||||units on a scale||Standard Deviation|Mean
2820233|NCT00382785|Primary|Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).|The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.|16 weeks||||Scores on a scale||Standard Error|Mean
2820234|NCT00382785|Primary|Scores on the CES-D Scale|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha >.85) of depression|16 weeks|Same as number of participants analyzed|||Scores on a scale||Standard Error|Mean
2820235|NCT00382785|Primary|Scores on the Personal Resource Questionnaire 85.|The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90|16 weeks||||Scores on a scale||Standard Error|Mean
2820248|NCT00382408|Secondary|Percentage of Participants Showing ADV-4 Seroconversion at Week 4|ADV-4 seroconversion was defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-4 titer was <1:4.|Week 4|Type-4 ADV Seroconversion Cohort: Included those subjects who had a negative Type-4 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-4 at the subsequent visits following vaccination.|||percentage of participants||95% Confidence Interval|Number
2820236|NCT00382733|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of disease progression. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Best overall response was assessed after every 8 weeks of treatment and at the end of treatment or time of disease progression, up to 1 year.|All enrolled subjects were analyzed for this outcome.|||participants|||Number
2820237|NCT00382733|Secondary|Dose Limiting Toxicities (DLT)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. This measure reports the number of subjects who experienced DLT at each dose level during the dose finding portion of the study.|DLTs were assessed during the first cycle of treatment (days 1-28).|Number of participants analyzed refers to those for whom DLT information was available during the dose finding portion of the study.|||participants|||Number
2820238|NCT00382733|Primary|Maximum Tolerated Dose (MTD) of Single Agent Metronomic Oral Topotecan|The MTD of metronomic oral topotecan was determined using a standard 3+3 dose escalation cohort design. The total sample and the number of subjects who receive each dose in this design depends on the frequency of dose limiting toxicities (DLTs)at each dose level. If 0 out of 3 subjects experience a DLT at a given dose level, 3 subjects will be enrolled at the next higher dose level. If greater than or equal to 2 subjects experience a DLT at a given dose level, dose escalation will be stopped. If 1 out of 3 subjects experience a DLT at a given dose level, 3 subjects are enrolled at the same dose level.|MTD was assessed during the first cycle of treatment (days 1-28).|DLT information was available for 3 subjects who received a topotecan dose of 0.25 mg/day, 3 subjects who received a topotecan dose of 0.50 mg/day, 3 subjects who received a topotecan dose of 0.75 mg/day, 3 subjects who received a topotecan dose of 1.0 mg/day, and 2 subjects who received a topotecan dose of 1.25 mg/day.|||mg/day|||Number
2820239|NCT00382720|Secondary|Overall Survival (OS)|The number of months measured from the date of randomization to the date of death due to any cause.|up to a maximum of 36 months|248 participants in the full analysis population (FAP).|||months||95% Confidence Interval|Median
2820240|NCT00382720|Secondary|Best Overall Response Rate (ORR)|"Percentage of partial and complete responses, according to WHO criteria:~Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).|||percentage of participants||95% Confidence Interval|Number
2820241|NCT00382720|Primary|Time to Progression|"The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.~WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).|||Months||95% Confidence Interval|Median
2820242|NCT00382590|Primary|Number of Participants With Response|Patient response defined by: Death, Resistant to Therapy [no major hematologic improvement using International Myelodysplastic Syndromes (MDS) Working Group (Cheson B, Bennett J, Kantarjian H et al, Blood 2006) criteria after a maximum of 4 courses], or Relapse.|Evaluated every 3 weeks, following 4 courses (16/24 weeks ) and till study end|The analysis was per intention to treat. One participant was inevaluable for response.|||Participants|||Number
2820243|NCT00382408|Secondary|Percentage of Participants Showing ADV Type-7 Booster at Week 4|ADV-7 booster effect is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-7 titer is ≥1:4.|Baseline, Week 4|Type-7 ADV Booster Cohort included subjects who had a positive Type-7 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-7 at the subsequent visits following study medication administration.|||percentage of participants||95% Confidence Interval|Number
2820244|NCT00382408|Secondary|Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-7 vaccine, the number of cases of ADV-7 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
2820245|NCT00382408|Secondary|Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-7 vaccine, a secondary outcome is the number of cases of ADV-7 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
2820246|NCT00382408|Secondary|Percentage of Participants Showing ADV Type-4 Booster at Week 4|ADV-4 booster effect is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-4 titer is ≥1:4.|Baseline, Week 4|Type-4 ADV Booster Cohort included subjects who had a positive Type-4 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-4 at the subsequent visits following study medication administration.|||percentage of participants||95% Confidence Interval|Number
2820247|NCT00382408|Secondary|Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-4 vaccine, the number of cases of ADV-4 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
2820249|NCT00382408|Primary|Percentage of Participants Showing ADV-7 Seroconversion at Week 4|ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was <1:4.|Week 4|Type-7 ADV Seroconversion Cohort: Included those subjects who had a negative Type-7 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-7 at the subsequent visits following vaccination.|||percentage of participants||95% Confidence Interval|Number
2820250|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period.|Day 11 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
2820251|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort.|Day 0 - Day 56|The per-protocol (PP) cohort included all participants who met the eligibility criteria set forth in the protocol, did not have any significant violations or deviations from the protocol, and completed the final study visit (Day 56). Subjects who vomited within 24 hours after taking the study medication were excluded from the PP cohort.|||participants|||Number
2820252|NCT00382408|Primary|Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort|For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.|Day 0 - Day 56|The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.|||participants|||Number
2820253|NCT00382291|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score|The CY-BOCS (Scahill et al., 1997) is a semi-structured, clinician rated instrument to measure OCD symptom severity in youth. The CY-BOCS contains a symptom checklist and a severity scale. Through the symptom checklist the clinician assesses current and past experiences of over 60 potential obsessions and compulsions. The Total Score represents the sum of obsession severity and compulsion severity which each consist of five clinician ratings on a Likert scale (range from 0 (none) to 4 (extreme), for time spent, interference, distress, resistance and control over symptoms). Summing of obsession and compulsion severity (range 0-20 on each) produces the Total CY-BOCS score (range 0-40, with 0 representing the best and 40 the worst outcome). Studies have documented good psychometric properties of the CY-BOCS (Gallant et al., 2008; Scahill et al., 1997; Storch et al., 2004).|Measured at Week 18 or End of Study||||units on a scale||Standard Deviation|Mean
2820254|NCT00382291|Primary|Clinical Global Impression - Severity of Activation (CGI-SA)|The CGI-SA was adapted from the Clinical Global Impressions - Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA obtained over the course of study.|Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study|Per protocol, Intent to treat|||units on a scale||Standard Deviation|Median
2820255|NCT00382265|Secondary|Return to Work (if Employed)||28 days||||Participants|||Count of Participants
2820256|NCT00382265|Secondary|Confirmation of Stone Passage on CT||28 days||||Participants|||Count of Participants
2820257|NCT00382265|Secondary|Crossover to Open Label Tamsulosin||28 days||||Participants|||Count of Participants
2820258|NCT00382265|Secondary|Need for Surgical Intervention||28 days||||Participants|||Count of Participants
2820259|NCT00382265|Secondary|Any Pain Medication|Patients on any pain medication at day 28|28 days||||Participants|||Count of Participants
2820260|NCT00382265|Primary|Proportion of Patients Passing Their Stone Within 28 Days by Self Report|Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.|28 days||||Participants|||Count of Participants
2820261|NCT00382174|Secondary|Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days|Incidence of wound healing at the end of the study, Day 84|Up to 84 days|Analysis was per protocol,ITT, and using LOCF|||Number of healed participants|||Number
2820262|NCT00382174|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days|All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population|Up to 84 days||||participants|||Number
2820263|NCT00382148|Secondary|Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.|Through Week 52|safety-evaluable population|||participants|||Number
2820264|NCT00382148|Secondary|Food-allergic Reactions As Assessed by the Ewan Scale|"The Ewan scale has five ascending grades of severity from Grade 1 to Grade 5 (as well, there is a possible value of Not Applicable). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator"|Through Week 52|safety-evaluable population|||participants|||Number
2820280|NCT00382018|Other Pre-specified|Correlation of CTC Levels With Breast Cancer Tumor Markers||Baseline, Weeks 4, 8, 13, 25, 37 and at progression|||||||
2820265|NCT00382148|Secondary|Food Allergen Exposure, Assessed on Patient-reported Questionnaire|"Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify) and Did you have a reaction? (Yes/No)."|Every 4 weeks through Week 52||||participants|||Number
2820266|NCT00382148|Primary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|Through Week 52|Safety-analysis population|||participants|||Number
2820267|NCT00382109|Secondary|Chimerism|Evaluate the relative contribution of resistance by ALL blasts to the donor immune response as a cause of relapse post transplantation.|Up to 12 months|We are not able to perform this analysis given the low numbers of blast samples available.||||||
2820268|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Pre-Transplantation (MRD)|An event is defined as relapse; relapse risk is reported. Not able to be performed given the low numbers of blast samples available.|At 2 months|The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol. However, we are not able to perform this analysis given the low numbers of blast samples available.||||||
2820269|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse)|An event is defined as relapse; estimated probability of relapse.|At 1 year|Number at risk among no aGVHD and number at risk among aGVHD at 1 year. The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol, therefore results are not reported for each Arm of study.|||percentage of participants|||Number
2820270|NCT00382109|Secondary|Relative Contribution of Resistance by Acute Lymphoblastic Leukemia (ALL) Blasts to Cytolytic Therapy (e.g., Chemotherapy/Irradiation) as a Cause of Relapse Post-transplantation|An event is defined as relapse or transplant-related mortality.|Up to 1 year|We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.||||||
2820271|NCT00382109|Secondary|Estimated Rate of Overall Chronic Graft VS Host Disease|Chronic graft vs host disease is defined in APPENDIX III of study protocol.|At 2 years|2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.|||percentage of participants||95% Confidence Interval|Number
2820272|NCT00382109|Secondary|Estimated Rate of Acute Graft VS Host Disease (GVHD)|Any grade acute graft vs host disease (defined in APPENDIX II study protocol).|At 200 days|2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.|||percentage of participants||95% Confidence Interval|Number
2820273|NCT00382109|Secondary|Estimated Transplant Related Mortality Percentage|Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.|100 days|2 ineligible patients on experimental arm excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2820274|NCT00382109|Secondary|Rate of Relapses|An event is defined as relapse.|At 2 years|2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.|||percentage of participants||95% Confidence Interval|Number
2820275|NCT00382109|Primary|Estimated Percentage of Participants With Event Free Survival|An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.|at 2 years|Two ineligible patients on experimental arm excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2820276|NCT00382031|Secondary|Progression Free Survival (PFS)|PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.|From randomization until disease progression or death, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||weeks||95% Confidence Interval|Median
2820277|NCT00382031|Secondary|Duration of Response|Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.|Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||month||95% Confidence Interval|Median
2820278|NCT00382031|Secondary|Objective Tumor Response|Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|From date of randomization until the date of death from any cause, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||participants|||Number
2820279|NCT00382031|Primary|Overall Survival|A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.|From randomization until death|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.|||months||95% Confidence Interval|Median
2820281|NCT00382018|Secondary|Number of Patients With Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression|Patients in 'Arm A (Baseline CTCs < 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results.|||Participants|||Number
2820282|NCT00382018|Primary|Progression Free Survival|From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.|every 3 months until progression|Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.|||months||95% Confidence Interval|Median
2820283|NCT00382018|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months until progression then every 6 months for 5 years or until death||||months||95% Confidence Interval|Median
2820284|NCT00382018|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.|Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.|||months||95% Confidence Interval|Median
2820285|NCT00382018|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months until progression then every 6 months for 5 years or until death||||months||95% Confidence Interval|Median
2820286|NCT00381966|Primary|Utility of the Needle Position Device: Number of Adjustments Possible Out of Adjustments Attempted|Utility was demonstrated in terms of fine adjustments (≤ 2 mm) and adjustments >2mm in needle positioning, being possible when tissue deflection was encountered.|at time of intervention||||Number of Adjustments|Number of Adjustments||Count of Units
2820287|NCT00381966|Primary|Positioning Effectiveness as Determined by Confirmatory Measurements of Robotic Movements|Confirmatory measurements of robotic movements was assessed using infrared tracking to calculate mean error in millimeters.|at time of intervention||||millimeters||Standard Deviation|Mean
2820288|NCT00381940|Secondary|Biological Markers|Assessing baseline NF-kB protein levels in tumor tissue|Before, during, and after treatment|||||||
2820289|NCT00381940|Secondary|Rate of Successful PBSC Harvest|Success is defined as the ability to harvest 2x10^6 CD34+ cells/kg within 5 collection days.|After 2 cycles|||||||
2820290|NCT00381940|Secondary|Induction Success Rate|Induction success is defined as achieving CR or PR without a targeted primary toxicity.|After 2 cycles and 4 cycles|||||||
2820291|NCT00381940|Secondary|Overall Response Rate|Overall response includes complete response and partial response.|After 2 cycles and 4 cycles|||||||
2820292|NCT00381940|Secondary|Toxicity||4 weeks following completion of therapy|||||||
2820293|NCT00381940|Primary|Complete Response (CR)|CR is defined as at least 80% reduction in the sum of the products of the perpendicular diameters of each of the nodal masses or return to normal size, along with negative nuclear medicine imaging.|After 2 cycles of treatment|Analysis population includes all patients evaluable for tumor response. Three enrolled patients are excluded: 1 ineligible, 1 who was removed from treatment after 1 dose of bortezomib, and 1 who received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 due to pharmacy error.|||participants|||Number
2820294|NCT00381888|Secondary|Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.|This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.|Week 4|These patients completed the study and are considered evaluable for this outcome measure.|||Participants|||Number
2820295|NCT00381888|Primary|Number of Patients With Venous Thromboembolism at Week 4|Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.|Week 4 (Days 28-35)|The number includes those patients who completed the study and are evaluable for this outcome measure.|||Participants|||Number
2820296|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy||within 5 days of chemotherapy|||||||
2820297|NCT00381862|Secondary|To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.||Duration of time patient is on study|||||||
2820298|NCT00381862|Secondary|Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.||Duration of time the patient is on study|||||||
2820299|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy||Duration of time that the patient is on study|||||||
2820300|NCT00381862|Primary|Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.||Up to 24 weeks||||Participants|||Number
2820301|NCT00381849|Primary|Volume of Kidney Stones as Measured on Computerized Tomography|Measurement of kidney stone volume in cubic millimeters.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study.|||mm^3||Standard Deviation|Mean
2820302|NCT00381849|Primary|Stone Density as Measured by Agatston Score Via Computerized Tomography|Agatston results are a measure of calcium typically used for measuring coronary artery calcification.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study|||Agatston Score||Standard Deviation|Mean
2820304|NCT00381849|Secondary|Change in Stone Burden as Assessed by Radiologist at One Year|Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.|Baseline, approximately 52 weeks after baseline|One subject in the Calcium group was excluded from the CT analysis because of bilateral stone removal surgery during the study.|||Kidneys|||Number
2820305|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Hydroxyapatite was not analyzed for the Cystine Stone subjects.|||KJoules/mol||Standard Deviation|Mean
2820306|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Brushite was not analyzed for the Cystine Stone subjects.|||KJoules/mol||Standard Deviation|Mean
2820307|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|CaOx was not analyzed for the Cystine Stone subjects.|||KJoules/mol||Standard Deviation|Mean
2820308|NCT00381810|Primary|Percentage of Participants With at Least 1 Serious Adverse Event|A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.|Baseline to the end of the study (up to 52 weeks)||||Percentage of participants|||Number
2820309|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-R2 Expression|The association of VEGF-R2 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-R2 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of VEGF-R2 expression with progression-free survival.|||Hazard Ratio||95% Confidence Interval|Number
2820310|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-A Expression|The association of VEGF-A expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-A measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of VEGF-A expression with progression-free survival.|||Hazard Ratio||95% Confidence Interval|Number
2820311|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Carbonic Anhydrase 9 (CA9) Expression|The association of CA9 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with CA9 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Only the number of patients in strata E was sufficient to perform the analysis exploring the association of carbonic anhydrase 9 (CA9) expression with progression-free survival.|||Hazard Ratio||95% Confidence Interval|Number
2820312|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Hypoxia Inducible Factor-2alpha Expression|The association of hypoxia inducible factor-2alpha expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with hypoxia inducible factor-2alpha measurements. The hazard ratio was reported for patients who had hypoxia inducible factor-2alpha expression.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|The number of patients in strata C and D was not sufficient to perform the analysis exploring the association of hypoxia inducible factor-2alpha expression with progression-free survival. Thus the association analysis was performed for the patients in Stratum E only.|||Hazard Ratio||95% Confidence Interval|Number
2820313|NCT00381797|Secondary|Number of Patients With High VEGF-R2 Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
2820314|NCT00381797|Secondary|Number of Patients With High VEGF-A Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
2820315|NCT00381797|Secondary|Number of Patients With High Carbonic Anhydrase 9 Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
2820316|NCT00381797|Secondary|Number of Patients With High Hypoxia Inducible Factor-2alpha Expression at Baseline|The expression of Hypoxia inducible factor-2α, carbonic anhydrase IX (CA9), VEGF-A, and VEGF-R2 will be estimated by immunohistochemistry of paraffin sections in the medulloblastoma,ependymoma and low grade glioma strata. Reported separately for each stratum.|Baseline|Only strata were reported, in which the patients had tissue samples available.|||participants|||Number
2820317|NCT00381797|Secondary|Correlation of the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline With the Change in Perfusion From Magnetic Resonance Imaging|Spearman correlation coefficient is used to measure the correlation of the changes in VEGF-R2 with the changes in perfusion ratios. The changes are calculated by values at Day 15 minus values at baseline for VEGF-2 in Section 17 above and perfusion in Section 18 above, respectively. The correlation coefficients are reported in each stratum separately.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.|||Correlation Coefficient|||Number
2820318|NCT00381797|Secondary|Descriptive Statistics for the Change of Perfusion in Magnetic Resonance Imaging Concurrently Measured With the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC)|The change of perfusion in magnetic resonance imaging is calculated by taking the difference between the Day-15 measurements and the Baseline measurements for patients who had the changes of VEGF-R2. The purpose of reporting the descriptive statistics is to provide the information for the correlation coefficients reported in the next section, Section 19. MR perfusion ratio is the ratio of the perfusion measurements in the tumor and the perfusion measurerement in comparative frontal while matter, which is the comparative healthy part of the brain.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.|||Ratio||Standard Error|Mean
2820319|NCT00381797|Secondary|Descriptive Statistics for the Changes in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) Concurrently Measured With the Changes in Perfusion From Magnetic Resonance Imaging|The changes in VEGF-R2 are calculated by values at Day 15 minus values at baseline for the patients who had the changes in perfusion from magnetic resonance perfusion imaging. The purpose of reporting descriptive statistics of changes of VEGF-R2 is to provide the information for the correlation coefficients in Section 19.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.|||Ratio||Standard Error|Mean
2820320|NCT00381797|Secondary|Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline to Day-15|The change in VEGF-R2 was calculated from baseline to the time of the 2nd dose (values of 24-48 hours after the 2nd dose at Day 15 - values of pre-dose 1 Day1, i.e., baseline). VEGF-R2 is measured in the relative phosphorylation score which is generated as a ratio of normalized phosphorylated VEGF-R2 versus normalized total VEGF-R2 protein.|Baseline and 24-48 hours after the 2nd dose of Bevacizumab in course 1||||Ratio||Full Range|Median
2820321|NCT00381797|Secondary|Terminal Half-life|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the PK parameters. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology,2016 volume 81(1):148-160. The estimates of the terminal half-life were calculated by the method described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with available data.|||hours||Standard Deviation|Mean
2820322|NCT00381797|Secondary|Systemic Clearance|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the systemic clearance. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology, 2016 volume 81(1):148-160. The estimates of the systemic clearance were calculated by the model described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with available data.|||ml/h||Standard Deviation|Mean
2820323|NCT00381797|Secondary|Volume of Distribution|"Blood specimens were collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens were analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data were analyzed to provide an estimate of the volume of distribution. The data were collected but the analyses of the PK data were conducted by Genentech using a broader cohort of pediatric patients from multiple trials in the paper Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation published by British Journal of Clinical Pharmacology ,2016 volume 81(1):148-160. The estimates of the volume of distribution were calculated by the model described in the paper."|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1|The study participants across the strata (stratum A, stratum B, stratum C, stratum D, and stratum E) were combined for this secondary objective. The number of participants with available data.|||ml||Standard Deviation|Mean
2820356|NCT00381641|Primary|Objective Response Rate, Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 2 years||||Participants|||Count of Participants
2820324|NCT00381797|Secondary|Association of Log-transformed Tumor Perfusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor perfusion ratio with progression-free survival will be investigated. Magnetic resonance (MR) perfusion imaging is performed to investigate surrogate markers of tumor growth. Tumor perfusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume perfusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|The analyses cannot be performed with the Cox proportional hazard model since there are no sufficient measurements of perfusion ratio and events.||||||
2820325|NCT00381797|Secondary|Association of Log-transformed Tumor Diffusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor diffusion ratios with progression-free survival will be investigated. Magnetic resonance (MR) diffusion imaging is performed to investigate surrogate markers of tumor growth. Tumor diffusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. And we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor diffusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Patients had diffusion ratio at pre-treatment scans and at least one on treatment scans.|||Hazard Ratio||95% Confidence Interval|Mean
2820326|NCT00381797|Secondary|Association of Log-transformed Volume of Cystic Necrosis With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of cystic necrosis with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Volumes of cystic necrosis were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on cystic necrosis. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had volume of cystic necrosis at Pre-treatment and at least one on treatment.|||Hazard Ratio||95% Confidence Interval|Mean
2820327|NCT00381797|Secondary|Association of Log-transformed Tumor Enhancing Volume With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional hazards Models, the association of Log-transformed tumor enhancing volume with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Tumor enhancing volumes were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor enhancing volume. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had tumor enhancing volume at Pre-treatment and at least one on treatment.|||Hazard Ratio||95% Confidence Interval|Mean
2820328|NCT00381797|Secondary|Association of Log-transformed Tumor Volume Based on FLAIR With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox proportional hazards models, the association of tumor volume based on FLAIR images with PFS will be investigated for those strata that have a sufficient number of participants with volume FLAIR measurements. Volumetric magnetic resonance imaging is performed to investigate surrogate markers of tumor growth. Volume FLAIR measurements were longitudinal. As we are not comparing the strata, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on FLAIR. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study OR up to 2 years|Patients had Flair volume at Pre-treatment and at least one on treatment.|||Hazard Ratio||95% Confidence Interval|Mean
2820329|NCT00381797|Secondary|Change in Diffusion Ratio Between the Baseline and Day 15 Brain Image|Diffusion ratio obtained from magnetic resonance (MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the diffusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from diffusion ratio at Baseline to diffusion ratio at Day 15 (values of diffusion ratio at Day 15 -values of diffusion ration at baseline). The higher of diffusion ratio is better. MR diffusion ratio is the diffusion solid part of tumor divided by the diffusion frontal white matter. There is no a unit available.|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm.|||Ratio||Full Range|Median
2820357|NCT00381628|Primary|The Number of Participants With Blood and Sputum Samples Collected|Blood and sputum samples for general science research collaborators|Baseline|These samples were to be distributed to research collaborators and were not part of a clinical trial. These samples were not analyzed for a specific outcome.|||Participants|||Count of Participants
2820330|NCT00381797|Secondary|Change in Perfusion Ratio Between the Baseline and Day 15 Brain Imaging|"Perfusion ratio obtained from magnetic resonance(MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the perfusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from perfusion ratio at Baseline to perfusion ratio at Day 15(values of perfusion ratio at Day 15 - values of perfusion ratio at baseline). The higher of perfusion ratio is worse.~MR perfusion ratio is perfusion solid part of tumor from CBV divided by perfusion frontal while matter. There is no a unit available."|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm and Ependymoma arm.|||Ratio||Full Range|Median
2820331|NCT00381797|Secondary|Progression-free Survival|Progression-Free survival is the interval of time between of protocol treatment and minimum date of documentation of progressive Disease,second malignancy,death due to any cause, or date of last follow-up. Progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression,OR the appearance of new tumor OR a > 25% increase in the sum of the products of two longest perpendicular diameters of all measurable tumors. K-M method was used to estimate progression-free survival.|From start of treatment up to 2 years|The patients were treated with any dose treatment.|||Months||95% Confidence Interval|Median
2820332|NCT00381797|Secondary|Cumulative Incidence of Sustained Objective Responses|Cumulative incidence of sustained objective response provides a percentage of participants experiencing the event of interest at a given follow-up time point (for example, 6-months, 1-year, etc.) in the presence of competing events such as progressive disease or death, and it is estimated using the event data for both the event of interest and the competing events experienced by the study participants. In this sense, it is different than the incidence rates estimated in epidemiological studies in terms of 'incidences per 1000 person years. 6-month Cumulative incidence of sustained objective responses will be reported separately for each stratum.|From the first imaging after treatment up to 2 years|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.|||Percentage of Participants|||Number
2820333|NCT00381797|Secondary|Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity|Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events. The grade 1 = mild, grade 2=moderate, grade 3 =severe, grade 4=life threatening/disabling, grade 5=death.|From day 1 of treatment until off study|The patients were treated with any dose treatment.|||participants|||Number
2820334|NCT00381797|Primary|Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)|Disease stabilization is defined as a complete response(CR) or partial response(PR) observed during the first four courses and sustained for 8 weeks; or stable disease (SD) sustained for 6 courses characterized by SD at the end of course 2, at the end of course 4 and at the end of course 6. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. SD is at least stable and maintenance corticosteroid dose not increased in neurologic examination.|From day 1 of treatment up to 24 weeks|Patients with recurrent or progressive low grade glioma were treated with any courses.|||participants||95% Confidence Interval|Number
2820335|NCT00381797|Primary|Objective Response Rate Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response observed during the first four courses of treatment and sustained for 8 weeks. The objective response rate will be reported separately for patients with recurrent/progressive malignant glioma(Stratum A), recurrent/progressive instrinsic brain stem tumors(Stratum B), recurrent/progressive medulloblastoma(Stratum C), and recurrent/progressive ependymoma(Stratum D). CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. This outcome measures is not defined for the Stratum E in the protocol.|From day 1 of treatment up to 24 weeks|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.|||participants|||Number
2820336|NCT00381706|Secondary|Time to Treatment Failure in Patients With Adenocarcinoma|Time to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment||||months||95% Confidence Interval|Median
2820337|NCT00381706|Secondary|Progression-free Survival in Patients With Adenocarcinoma|Progression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment||||months||95% Confidence Interval|Median
2820338|NCT00381706|Secondary|Overall Survival in Patients With Adenocarcinoma|Overall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 2 years post-treatment||||months||95% Confidence Interval|Median
2820339|NCT00381706|Secondary|Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy.|Up to 2 years post-treatment|4 participants did not meet the protocol defined requirements to be evaluated for response (measurable squamous cell carcinoma receiving at least 1 cycle of chemotherapy).|||percentage of participants|||Number
2820340|NCT00381706|Primary|Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.|Up to 2 years post-treatment|13 participants did not meet the protocol defined requirements to be evaluated for response (measurable adencarcinoma receiving at least 1 cycle of chemotherapy).|||percentage of participants||95% Confidence Interval|Number
2820341|NCT00381693|Secondary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.~Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Every 4 weeks during treatment||||Participants|||Number
2820342|NCT00381693|Secondary|Time to Progression|Time to progression was defined as the time from registration to progression of disease. Those who die without documentation of disease progression will be considered to have had disease progression at the time of their death unless documented evidence clearly indicates no progression has occured.|up to 3 years|Only 2 out of 10 patients had disease progression. One patient progressed at 0.5 months after registration and one patient progressed at 2.8 months after registration. Thus, median of time to progression and upper limit of 95% confidence interval are not attainable.|||months||95% Confidence Interval|Median
2820343|NCT00381693|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.|From date of registration until death or 3 years after registration if patient is still alive||||months||95% Confidence Interval|Median
2820344|NCT00381693|Primary|Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment|"Response Definitions:~Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed.~Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category."|4 months||||participants|||Number
2820345|NCT00381680|Secondary|Adjusted Event Free Survival|Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).|3 years|The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.|||adjusted percentage of participants||95% Confidence Interval|Number
2820346|NCT00381680|Secondary|Event Free Survival (EFS)|Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months.|3 years|The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. Pts with MRD <0.01% at the end of Block 1 (MRD < 0.01% BL1); MRD >= 0.01% at the end of Block 1 (MRD>= 0.01% BL1); MRD < 0.01% at the end of Block 3 (MRD < 0.01% BL3);MRD >=0.01% at the end of Block 3.|||percentage of participants||95% Confidence Interval|Number
2820347|NCT00381680|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.|End of Block 3 (105 days) of Induction therapy|This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.|||percentage of participants|||Number
2820348|NCT00381680|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1|End of Block 1 (35 days) of Induction therapy|This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1.|||percentage of participants|||Number
2820349|NCT00381680|Secondary|Gene Expression Profile|Percent of unfavorable gene expression profile of early versus late marrow relapse.|Up to 36 months|The data were not collected due to the lack of funds.||||||
2820350|NCT00381680|Secondary|Frequency and Severity of Adverse Effects|Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.|Up to 107 weeks|The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.|||percentage of participants||95% Confidence Interval|Number
2820351|NCT00381680|Primary|Event Free Survival. EFS|Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).|3 years after enrollment|The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.|||percentage of participants EFS at 3 yrs3||95% Confidence Interval|Number
2820352|NCT00381641|Other Pre-specified|Changes in Laboratory Correlates Analyzed Using Paired T-tests|Relevant laboratory correlates will be compared between responders and non-responders using the Wilcoxon rank sum test. The association between the presence or absence of RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorphisms in the RET gene and response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as covariates (univariate analyses only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline to 2 years|||||||
2820353|NCT00381641|Secondary|Time to Progression or Death Evaluated Using the RECIST||Time from start of treatment to time of progression or death of any cause, assessed up to 10 years||||Months||95% Confidence Interval|Median
2820354|NCT00381641|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 95% confidence intervals will be derived for median overall survival.|Up to 10 years||||Months||95% Confidence Interval|Median
2820355|NCT00381641|Secondary|Incidence of Toxicity, Graded According to the Common Terminology Criteria for Adverse Events Version 3.0|Any grade toxicity of any type, regardless of attribution|From time of first treatment with sunitinib, assessed up to 2 years||||Participants|||Count of Participants
2825129|NCT00343564|Secondary|Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
2820358|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.|At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.||||Percentages of Subjects||95% Confidence Interval|Number
2820359|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.|At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.||||Percentages of Subjects||95% Confidence Interval|Number
2820360|NCT00381615|Secondary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age|Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age.|1 month after first vaccination||||Ratio||95% Confidence Interval|Geometric Mean
2820361|NCT00381615|Primary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination||||Ratio||95% Confidence Interval|Geometric Mean
2820362|NCT00381615|Primary|Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.|Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.|30 days after the third vaccination|Analysis was performed on the Per Protocol Set (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentage of Subjects||95% Confidence Interval|Number
2820363|NCT00381615|Primary|Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study|Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
2820364|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
2820365|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
2820366|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.|||Number of subjects|||Number
2820367|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2820368|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set after booster vaccination.|||Percentage of subjects||95% Confidence Interval|Number
2825130|NCT00343564|Secondary|Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||ng/mL||Standard Deviation|Mean
2820369|NCT00381615|Secondary|Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.|30 days after the second vaccination and 1 month after fourth (booster) vaccination|Analysis was performed on the PP set.|||ratios||95% Confidence Interval|Geometric Mean
2820370|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ|Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set.|||titers||95% Confidence Interval|Geometric Mean
2820371|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age|Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.|prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination|Analysis was performed on the PP set.|||titers||95% Confidence Interval|Geometric Mean
2820372|NCT00381615|Primary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the PP set.|||titers||95% Confidence Interval|Geometric Mean
2820373|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.|1 month after first vaccination|Analysis was performed on the PP set.|||Percentage of subjects||95% Confidence Interval|Number
2820374|NCT00381615|Primary|Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization|Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.|||Percentage of subjects||95% Confidence Interval|Number
2820375|NCT00381563|Secondary|Change in WOMAC Function Scale|The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."|||units on a scale change from baseline||95% Confidence Interval|Mean
2820376|NCT00381563|Primary|Change in WOMAC Pain Scale|The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."|||units on a scale change from baseline||95% Confidence Interval|Mean
2820377|NCT00381563|Primary|Change in Pain on the VIsual Analog Scale (VAS)|The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100|6 weeks|"In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the intervention brace group."|||change in units on a scale from baseline||95% Confidence Interval|Mean
2820378|NCT00381550|Primary|Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0||Up to 4 years||||participants|||Number
2820379|NCT00381550|Primary|Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation|Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.).|Up to 4 years||||participants|||Number
2820380|NCT00381485|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)|Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled.|12-week Treatment Period|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Proportion of nights||Standard Deviation|Least Squares Mean
2820381|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Units on a Scale||Standard Deviation|Least Squares Mean
2820382|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Units on a Scale||Standard Deviation|Least Squares Mean
2820383|NCT00381485|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).|||Liter x hour||Standard Deviation|Least Squares Mean
2820384|NCT00381381|Primary|CERAD-K|CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.|26 weeks||||Second||Standard Deviation|Mean
2820385|NCT00381381|Secondary|GDS-K (Geriatric Depression Scale-Korean) Score After Treatment|GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.|26 weeks||||Units on Scale||Standard Deviation|Mean
2820386|NCT00381381|Secondary|Neuropsychiatry Inventory (NPI)|NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.|26 weeks||||Units on Scale||Standard Deviation|Mean
2820387|NCT00381381|Primary|CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)|CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).|26 weeks||||Units on Scale||Standard Deviation|Mean
2820388|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)|||x10^6 Cells/L||Standard Error|Mean
2820389|NCT00381303|Primary|Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR non-virologic failure (VF) censored|||participants|||Number
2820390|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)|Last Observation Carried Forward (LOCF) imputation method applied.|Week 48|ITT LOCF|||x10^6 cells/L||Standard Error|Mean
2820391|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)|||x10^6 cells/L||Standard Error|Mean
2820392|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values|Observed obsevations have no imputation methods applied.|Baseline, Week 48|ITT|||x10^6 cells/L||Standard Error|Mean
2820481|NCT00380692|Secondary|Nijmeegse Ouderlijke Stress Index (NOSI) Total Score|The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.|||units on a scale||Standard Deviation|Mean
2820393|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA|"The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)~TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards."|Week 48|Etravirine-TMC125 (ETR) Subgroup [TLOVR Non-virologic Failure (VF) Censored]|||participants|||Number
2820394|NCT00381303|Secondary|Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR Non-virologic Failure(VF) Censored|||participants|||Number
2820395|NCT00381303|Secondary|Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|ETR Subgroup- Intention to Treat population (ITT)|||participants|||Number
2820396|NCT00381303|Secondary|Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race|Intention to Treat population (ITT)|Week 48|ITT|||participants|||Number
2820397|NCT00381303|Primary|Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex|TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability|Week 48|Intention to Treat (ITT)|||participants|||Number
2820398|NCT00381238|Secondary|Number of Participant's With Hematology Parameters of Clinical Concern|Participant data for clinical concern hematology parameters, were reported for hematocrit (Hct) (unit:1): low concern (LC) and high concern (HC) values as 0.8 and 1.2 respectively, hemoglobin (Hb) (unit: gram per deciliter): LC and HC values as value for female (F) 10 (AB) , value for male (M) 11; and value for F 16.5 (AB), value for M 18 respectively; lymphocytes absolute(LA) (unit: giga cells per litre [GI/L]) : LC and HC value as 0.75 and 1.5 respectively; monocytes absolute (MA) (unit: GI/L) LC and HC value as 0.75 and 2 respectively, platelet count (PC) (unit: x103/mm3): LC and HC value as 100 (AB) and 500(AB) respectively, red blood cell count (RBC) (unit: x106 micro litre): LC and HC value as 0.8 and 1.2 respectively, segmented neutrophils absolute (SNA) (unit: GI/L) LC and HC value as 0.75 and 1.3 respectively, total neutrophils absolute (TNA) (unit : GI/L) LC and HC value as 0.75 and 1.5 respectively; White blood cell (WBC) (unit: GI/L) LC and HC value as 3 and 15.|Up to Wk 50|All subjects population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||participant|||Number
2820399|NCT00381238|Secondary|Number of Participants With Clinical Chemistry Parameters of Clinical Concern-lipids|Participant data for clinical concern lipid parameters for Total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides was to be collected. However this data was not collected.|Up to Wk 50|All subject population. The data for 'The number of participants with clinical chemistry parameters of clinical concern- Lipids' was not collected.||||||
2820400|NCT00381238|Secondary|Number of Participants With Clinical Chemistry Parameters of Clinical Concern|The data for participants for clinical parameters, with values only of potential clinical concern (PCI) were reported for creatine, creatinine kinase(CK), urea and glucose. Creatinine(unit: micromoles per litre) : low concern and high concern values were considered as 22 absolute value (AB) (<50% lower limit of RR ) and 155 (AB) (>125% upper limit of RR) respectively. CK (unit: international unit per litre ): low concern value and high concern values was none and 1.25 respectively. Glucose (unit: millimole per litre): low concern and high concern values were considered as 3.6 (AB) and 7.8 (AB) respectively.|Up to Wk 50|All subjects population. 'n’ is participants available at the particular time of assessment which were included in analysis.|||participants|||Number
2820401|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs- Weight|The weight for the participant, was measured without wearing shoes and with light clothing. There was no particular RR, reported for weight; however, the increase from baseline was reported to be >=7 % and the decrease also reported as >=7 %. The values as of potential clinical concern were 'both' outside of RR, or met a change from baseline criterion.|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||kilograms||Standard Deviation|Mean
2820402|NCT00381238|Secondary|Number of Participants With Vital Signs of Clinical Concern.|The data for number of participants with vital sign data, outside the range of potential clinical concern for SBP, DBP, HR and body weight were reported. The values as of potential clinical concern were 'both' outside of reference range or met a change from baseline criterion. The RR, for SBP was 90-140 mmHg for which the increase from baseline was reported to be >= 40 mmHg and decrease from baseline reported as >=30 mmHg; the RR for DBP was 50-90 mmHg for which the increase from baseline was reported to be >= 30 mmHg and decrease from baseline reported as >=20 mmHg; and the RR, for HR was 50-100 bpm for which the increase from baseline was reported to be >= 30 bpm and the decrease from baseline reported as >=30 bpm. The data of number of participants with > clinical concern range (CCR) or < CCR were reported.|Up to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||participants|||Number
2820403|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs-heart Rate (HR)|The HR for the participant's, were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The HR was measured in beats per minute (bpm).|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||bpm||Standard Deviation|Mean
2820482|NCT00380692|Secondary|General Health Questionnaire (GHQ) Total Score|Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.|||units on a scale||Standard Deviation|Mean
2820404|NCT00381238|Secondary|Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.|Baseline (Wk 0) to Wk 50|All subject population. ‘n’ is participants available at the particular time of assessment which were included in analysis.|||mmHg||Standard Deviation|Mean
2820405|NCT00381238|Secondary|Number of Participants With AE of Peripheral Edema by Grade|Participants with AE of peripheral edema were evaluated. The test was performed by firmly pressing the thumb anterior to the participants ankle until further pressure produced no greater indentation. The depth of the pit was estimated and it was graded using below 5 point scale; where estimated depth of indentation corresponded to a particular grade (G). G 0 as depth of <1 millimeter (mm); G1 as depth of 1-2 mm; G2 as depth of 3-5 mm; G3 as depth of 6-10 mm; and G4 as depth of > 10 mm. The data for only the participants who had peripheral edema on more than one visit, then their most severe G were presented.|Up to Wk 50|All subject population|||participants|||Number
2820406|NCT00381238|Secondary|Number of Participants With SAEs|An SAE, is any untoward medical occurrence, that at any dose may result in death, is life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, is congenital anomaly or birth defect, and medically important events. The number of participants with any SAE, were reported.|From start of study medication (Wk 0) to Wk 50|All subject population|||participants|||Number
2820407|NCT00381238|Secondary|Mean Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE, is a score scale which consists of 11 tests of orientation (to time and place), memory (recent and immediate), concentration, language and praxis. The scoring ranged from 0 to 30, with lower scores indicative of greater cognitive impairment (more severe disease) and higher scores indicative less cognitive impairment (less severe disease). The total score was calculated by summing the scores from each of the tests. The investigator questioned the participants individually with set of questions and scored the participant, based on his performance. The baseline was defined as Wk 0. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values.|From baseline to Wk 48|Intent to treat (ITT). The ITT population consisted of all participants in the safety population who also had at least one post-dose efficacy assessment within this study.|||score on scale||Standard Deviation|Mean
2820408|NCT00381238|Primary|Number of Participants With Adverse Events (AE's)|An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study drug or withdrawal were reported.|From start of study medication (Wk 0) to Wk 50|All subject population, is defined as all the participants who received at least one dose of study drug.|||participants|||Number
2820409|NCT00381095|Secondary|Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28|ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.|Baseline, Day 28 or ET|Data not analyzed due to early study termination.||||||
2820410|NCT00381095|Secondary|Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28|OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.|Baseline, Day 14, Day 28 or ET|Data not analyzed due to early study termination.||||||
2820411|NCT00381095|Secondary|Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Weeks 2 and 4 or ET|ITT; LOCF; n=number of evaluable participants analyzed at each time point; N= the number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
2820412|NCT00381095|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4|HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed; individual symptoms not analyzed|||Units on a scale||Standard Deviation|Mean
2820413|NCT00381095|Secondary|Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28|IR and SR formulations separately and combined. Change was day x minus baseline.|Baseline, Day 0 through Day 28 or ET|Data not analyzed due to early study termination.||||||
2820414|NCT00381095|Secondary|Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28|Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.|Baseline, Day 0 through Day 28 or ET|Data no analyzed due to early study termination.||||||
2820415|NCT00381095|Secondary|Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4|Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.|Baseline, Weeks 1, 2, 3 and 4 or ET|Data not analyzed due to early study termination.||||||
2820509|NCT00380393|Secondary|Haemoglobin Values at Cross-Sectional Visit|Haemoglobin values are expressed in grams per deciliter (g/dL).|At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||g/dL||Standard Deviation|Mean
2820416|NCT00381095|Secondary|Change From Baseline in mBPI-sf Interference Index Score at Week 4|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
2820417|NCT00381095|Secondary|Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.|Baseline, Week 4 or ET|ITT; LOCF= Last observation carried forward; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
2820418|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET|ITT; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
2820419|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Day 1 to End of Dose Adjustment or ET|ITT; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
2820420|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Days 1 Through 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Days 1 through 28 or ET|ITT; N= number of participants with evaluable data analyzed|||Units on a scale||Standard Deviation|Mean
2820421|NCT00381095|Primary|Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28|DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.|Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)|Intent-To-Treat population (ITT): all randomized participants for whom at least one post-baseline efficacy evaluation was obtained; N= the number of participants with evaluable data analyzed; n= number of participants with evaluable data at the specific time point.|||Units on a scale||Standard Deviation|Mean
2820422|NCT00381043|Secondary|% Compliant With Medication|% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.|12 weeks||||percentage of participants|||Number
2820423|NCT00381043|Secondary|Clinical Global Impression Scale|Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|12 weeks||||units on a scale||Standard Deviation|Mean
2820424|NCT00381043|Secondary|% Heavy Drinking Days During Trial|% of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial.|12 weeks||||percentage of heavy drinking days||Standard Deviation|Mean
2820425|NCT00381043|Secondary|Percent With Complete Abstinence|% of subjects with no drinking during the 12 week treatment trial|12 weeks||||percentage of participants|||Number
2820426|NCT00381043|Primary|Percent Days Abstinent|%Days without any alcohol consumption over the treatment period|12 weeks||||percentage of days||Standard Deviation|Mean
2820427|NCT00381043|Primary|% Dropout|Percentage of participants who dropped out of study by drug condition|12 weeks||||percentage of participants|||Number
2820428|NCT00381043|Secondary|Retention|Number of individuals retained in the trial by acamprosate vs placebo group|12 weeks||||participants|||Number
2820429|NCT00381004|Primary|Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months||||Participants|||Number
2820430|NCT00381004|Secondary|Number of Participants Progression-free|Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level > 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression.|6 months or until disease progression if earlier||||participants|||Number
2820431|NCT00381004|Primary|Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months||||Percentage of Participants|||Number
2820432|NCT00380978|Secondary|Vomiting|Vomiting during labor analgesia|Vomiting at second analgesia request||||participants|||Number
2820433|NCT00380978|Secondary|Neonatal Outcome (APGAR Score < 7 at 5 Minutes)|Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal.|APGAR score at 5 minutes||||participants|||Number
2820434|NCT00380978|Secondary|Nausea|Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.|At second analgesia request||||participants|||Number
2820435|NCT00380978|Secondary|Analgesia Efficacy|Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request.|At first and second analgesia requests||||Scores on a scale||Inter-Quartile Range|Median
2820436|NCT00380978|Secondary|Indication for Cesarean Delivery|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Number of cesarean deliveries|||participants|||Number
2820437|NCT00380978|Secondary|Duration of Labor|Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.|Initiation of induction of labor to time of delivery|Per protocol|||minutes||Inter-Quartile Range|Median
2820438|NCT00380978|Secondary|Instrumented Vaginal Delivery|The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Per protocol - subjects that delivered vaginally|||participants|||Number
2820439|NCT00380978|Primary|Delivered by Cesarean Section|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis per protocol. 10 did not receive intervention in combined spinal epidural group and 2 in the systemic analgesia group|||participants|||Number
2820440|NCT00380874|Primary|Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).|Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF).|||score on scale||Standard Error|Least Squares Mean
2820441|NCT00380874|Secondary|Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms|Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.|Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint|ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||participants|||Number
2820442|NCT00380874|Secondary|Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.|Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
2820443|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
2820444|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
2820445|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.|||score on scale||Standard Error|Least Squares Mean
2820446|NCT00380861|Secondary|Single Leg Active Flexion at 2 Weeks, 6 Weeks, 6 Months and 12 Months.||2 weeks, 6 weeks, 6 months and 12 months|||||||
2820447|NCT00380861|Primary|Knee Society Passive Flexion at 6 Months|The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.|6 months||||Degrees of passive flexion||Standard Deviation|Mean
2820448|NCT00380861|Secondary|Subject Satisfaction||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820449|NCT00380861|Secondary|Crepitus||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820450|NCT00380861|Secondary|Ability to Perform Activities||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820451|NCT00380861|Secondary|Knee Pain||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820452|NCT00380861|Secondary|KOOS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820453|NCT00380861|Secondary|AKS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820454|NCT00380861|Secondary|Effect of Subject Demographics and Anthropometrics on ROM||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820455|NCT00380861|Secondary|Single Leg Passive Flexion at All Scheduled Follow-up Visits: 2 Weeks, 6 Weeks, 6 Months and 12 Months.||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up|||||||
2820456|NCT00380744|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score|HAQ was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ score. If the participant had scores for fewer than 6 categories, the HAQ score was considered missing. The HAQ score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, Days 35, 63, and 98|"All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.~Per protocol analysis was performed per dose irrespective of study parts."|||units on a scale||95% Confidence Interval|Least Squares Mean
2820457|NCT00380744|Secondary|Change From Baseline in C-Reactive Protein (CRP)|CRP is a biomarker associated with inflammation and structural damage. A negative change from baseline indicates improvement. LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.|Baseline, Days 7, 14, 21, 28, 35, 63, and 98|"All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.~Per protocol analysis was performed per dose irrespective of study parts."|||milligrams/deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2820458|NCT00380744|Secondary|Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)|"DAS28-4 (crp) is a modification of the original DAS based on TJC and SJC based on 28 joint counts, PGA VAS. DAS28-4 (crp) calculated as: 0.56*square root (sqrt) (TJC)+0.28*sqrt(SJC)+0.36*ln(CRP+1)+0.014*PGA+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. A decrease in DAS28-CRP indicated an improvement in participant's condition.~LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time."|Baseline, Days 7, 21, 35, 63, and 98|"All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.~Per protocol analysis was performed per dose irrespective of study parts."|||units on a scale||95% Confidence Interval|Least Squares Mean
2820459|NCT00380744|Secondary|Change From Baseline in Simple Disease Activity Index Score (SDAI)|SDAI is calculated as the sum of 5 components: tender joint count (TJC) and swollen joint count (SJC), Patient Global Assessment (PtGA) of disease activity visual analog scale (VAS) and Physician's Global Assessment of Disease Activity (PGA) VAS, and C-reactive protein (CRP). Total Score scale range is 0 (remission) to 86 (high disease activity). A negative change from baseline indicated an improvement. Least Squares (LS) mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment * time.|Baseline, Days 7, 21, 35, 63, and 98|"All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.~Per protocol analysis was performed per dose irrespective of study parts."|||units on a scale||95% Confidence Interval|Least Squares Mean
2820520|NCT00380250|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1||||Scale Score||Standard Deviation|Mean
2820521|NCT00380250|Secondary|Month 3 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 3|ITT, with LOCF|||BM/week||Standard Deviation|Mean
2820460|NCT00380744|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102|"AUC0-168 hr,ss of individual participants was calculated by equation AUC=Dose/Clearance (CL), where the CL was estimated using a population PK model.~Time frame for Part B: Day 1 predose, immediately after infusion (IAI), Day 14 and 28: predose and IAI, and Day 63 (Convenient time);"|Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)|"All participants who received at least 1 dose of study drug in part A & B and had evaluable AUC0-168 hr,ss results.~Per protocol analysis was performed per dose irrespective of study parts."|||micrograms*hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2820461|NCT00380744|Primary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 98|"All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.~Per protocol analysis was performed per dose irrespective of study parts."|||Participants|||Count of Participants
2820462|NCT00380718|Secondary|Time to Tumor Progression|Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.|||months||95% Confidence Interval|Median
2820463|NCT00380718|Secondary|Time to Treatment Failure|Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. One patient was censored as he/she was alive at time of analysis.|||months||95% Confidence Interval|Median
2820464|NCT00380718|Secondary|Duration of Response|Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Participants who received study drug and who had either a complete or partial response to treatment. Three participants were censored as they were alive at the time of analysis.|||months||Full Range|Median
2820465|NCT00380718|Secondary|Progression-Free Survival (PFS)|Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.|||months||95% Confidence Interval|Median
2820466|NCT00380718|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.|baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.|||months||Full Range|Median
2820467|NCT00380718|Secondary|Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])|DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."|||proportion of participants||95% Confidence Interval|Mean
2820480|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates|"Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses yes when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses no when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100."|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||error rate (percentage)||Standard Deviation|Mean
2820468|NCT00380718|Primary|Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])|"The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."|||proportion of responders||95% Confidence Interval|Mean
2820469|NCT00380692|Secondary|Cytochrome P450 2D6 Genotype|Genotype characterization was used to determine participants' metabolic status.|baseline|All randomized participants.|||participants|||Number
2820470|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times|Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
2820471|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates|Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.|Baseline, 8 weeks|Number of participants with baseline and one non-missing postbaseline value at visit.|||error rate (percentages)||Standard Deviation|Mean
2820472|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates|Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||error rate (percentage)||Standard Deviation|Mean
2820473|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement|A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.|||millimeters||Standard Deviation|Mean
2820474|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy|A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.|||millimeters||Standard Deviation|Mean
2820475|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
2820476|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections|"Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A yes is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A yes is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct yes responses to targets. RT correct rejections are mean RTs of correct no responses when target was missing."|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
2820477|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates|"The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A yes is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a yes is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100."|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||error rate (percentage)||Standard Deviation|Mean
2820478|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
2820479|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.|||milliseconds||Standard Deviation|Mean
2820483|NCT00380692|Secondary|Children's Social Behavior Questionnaire (CSBQ) Total Score|CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.|||units on a scale||Standard Deviation|Mean
2820484|NCT00380692|Secondary|Aberrant Behavior Checklist (ABC)|The ABC is a 58-item informant-based scale comprised of five subscales (Irritability [15 items], Lethargy [16], Stereotypic Behaviors [7], Hyperactivity [16], Inappropriate Speech [4]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).|Baseline, 8 weeks, 28 weeks|Randomized participants with values at timepoint.|||units on a scale||Standard Deviation|Mean
2820485|NCT00380692|Secondary|Sleep Measure Scale|10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 [0-15 minutes] to 5 [>1 hour]); Total hours (numbers associated with hours of sleep).|Baseline, 8 weeks, 28 weeks|Randomized participants with a value at timepoint.|||units on a scale||Standard Deviation|Mean
2820486|NCT00380692|Secondary|ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|28 weeks|Randomized participants with a value at timepoint.|||units on a scale||Standard Deviation|Mean
2820487|NCT00380692|Secondary|Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 8 weeks, 28 weeks|Number of randomized participants who had a value at timepoint.|||units on a scale||Standard Deviation|Mean
2820488|NCT00380692|Secondary|Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|8 weeks, 28 weeks|Number of randomized participants with values at timepoint.|||units on a scale||Standard Deviation|Mean
2820489|NCT00380692|Primary|ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline and 8 weeks|Number of randomized participants with a value at baseline and 8 week endpoint. Last Observation Carried Forward analysis.|||units on a scale||Standard Deviation|Mean
2820490|NCT00380588|Other Pre-specified|Survival Time|Data of patients lost to follow-up were censored at the last date of confirmation of their survival.|baseline to date of death due to any cause (up to 2 years)||||months||95% Confidence Interval|Median
2820491|NCT00380588|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2820492|NCT00380588|Secondary|Tumor Response|"Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.|||participants|||Number
2820493|NCT00380588|Primary|Percentage of Patients Alive at 1 Year (1-Year Survival Rate)|Percentage of patients alive at 1 year.|1 year|Number of patients who received at least one dose of study drug.|||percentage of participants|||Number
2820494|NCT00380393|Secondary|Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|At Month 3|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
2820495|NCT00380393|Secondary|Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|At Month 3|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
2820496|NCT00380393|Secondary|Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|Prior to vaccination (Day 0)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
2820497|NCT00380393|Secondary|Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells|T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).|Prior to vaccination (Day 0)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||cells/million||Inter-Quartile Range|Median
2820498|NCT00380393|Secondary|Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).|At Day 0 and at Month 3|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2820499|NCT00380393|Secondary|Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2820500|NCT00380393|Secondary|Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades|Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820501|NCT00380393|Secondary|Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades|Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820502|NCT00380393|Secondary|Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades|Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10^3 /μL; Grade 2 Platelets = 25 to 49 x 10^3 /μL; Grade 3 Platelets = < 25 x 10^3 /μL.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820503|NCT00380393|Secondary|Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades|Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10^3 cells per microliters (cells/μL) or < 17 x 10^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10^3 cells/μL.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820504|NCT00380393|Secondary|Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades|Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (<) 8.0 g/dL and above (>) 6.0 g/dL.; Grade 2 Hemoglobin = under (<) 6.0 g/dL.|At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820505|NCT00380393|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (Day 0 - Month 14)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820506|NCT00380393|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Days 0-29) post-vaccination follow-up period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2820507|NCT00380393|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2820508|NCT00380393|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2820522|NCT00380250|Secondary|Month 2 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 2|ITT, with LOCF|||BM/week||Standard Deviation|Mean
2820523|NCT00380250|Secondary|Month 1 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 1|ITT, with LOCF|||BM/week||Standard Deviation|Mean
2820510|NCT00380393|Secondary|Geometric Mean Density of Asexual P. Falciparum Parasite|Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL).|At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||parasites/μL||95% Confidence Interval|Geometric Mean
2820511|NCT00380393|Secondary|Number of Subjects Positive for P. Falciparum Parasitaemia||At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||Participants|||Count of Participants
2820512|NCT00380393|Secondary|Multiple Events of Malaria Meeting the Secondary Case Definition|Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia > 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
2820513|NCT00380393|Secondary|Multiple Events of Malaria Meeting the Primary Case Definition|Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia > 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
2820514|NCT00380393|Secondary|Frequency of First Case Malaria Meeting the Secondary Case Definition|The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia > 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
2820515|NCT00380393|Primary|Frequency of First Case of Malaria Meeting the Primary Case Definition|The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.|Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)|The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.|||PYAR|||Number
2820516|NCT00380367|Primary|Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Pre-specified injection site AEs included pain, tenderness, erythema, and swelling. A vaccine-related AE was an AE considered by the investigator to be possibly, probably, or definitely related to the vaccine. All AEs collected on participant's Vaccination Report Card daily for 14 days after each vaccination (Days 1-15).~The number of participants who experienced ≥1 AE, the number of participants who experienced ≥1 injection site AE, the number of participants who experienced ≥1 systemic AE, and the number of participants who experienced ≥1 vaccine-related AE were reported for the Safety Cohort."|Up to 7 months|Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.|||participants|||Number
2820517|NCT00380367|Primary|Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7|Month 7 HPV competitive Luminex Immunoassay (cLIA) seroconversion rates among participants who received Quadrivalent HPV (Types 6, 11, 16, 18) Late 1 (L1) capsid protein VLP vaccine were reported. The quadrivalent HPV competitive cLIA (v2.0) was used to detect antibody to HPV VLPs serotypes 6, 11, 16, 18 before and after vaccination with the HPV quadrivalent vaccine. Seropositivity cutoffs of the HPV cLIAs were assessed using a panel of sera from participants highly likely to be HPV naïve (children), and from participants who were highly likely to be seropositive. Any sample with a value less than the cutoffs was considered serostatus negative. Samples with values equal to or greater than the cutoff were considered serostatus positive. The cutoffs for the HPV 6, 11, 16, and 18 cLIAs were 20 milli‐Merck units per milli liter (mMU/mL), 16 mMU/mL, 20 mMU/mL, and 24 mMU/mL, respectively.|One month post-dose 3 (Month 7)|Per‐Protocol (P-P) immunogenicity population: All participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were sero-negative at Day 1 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.|||percentage of participants||95% Confidence Interval|Number
2820518|NCT00380250|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3||||Scale Score||Standard Deviation|Mean
2820519|NCT00380250|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2||||Scale Score||Standard Deviation|Mean
2820537|NCT00380250|Secondary|Month 1 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse."|month 1 (28 days)|ITT without LOCF|||percent of participants|||Number
2820538|NCT00380250|Secondary|Month 3 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse."|month 3 (28 days)|ITT without LOCF|||percent of participants|||Number
2820539|NCT00380250|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|month 2 (28 days)|ITT without LOCF|||percent of participants|||Number
2820540|NCT00380250|Primary|Overall Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.~Overall responder: responder for at least 2/3 months"|12 weeks|Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2820541|NCT00380250|Secondary|Quality of Life Change From Baseline|Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|Change from baseline at 12 weeks|ITT without LOCF|||Scale score||Standard Deviation|Mean
2820542|NCT00380250|Secondary|Month 1 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
2820543|NCT00380250|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline at 28 days|ITT with LOCF|||Scale score||Standard Deviation|Mean
2820544|NCT00380250|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
2820545|NCT00380250|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 1|ITT with LOCF|||Scale score||Standard Deviation|Mean
2820546|NCT00380250|Secondary|Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline|SBMs are any bowel movement not associated with rescue medication use.|Change from baseline for month 1|ITT with LOCF|||SBM/week||Standard Deviation|Mean
2820547|NCT00380081|Post-Hoc|Subjective Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as documented by the participant for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population|||number of awakenings||95% Confidence Interval|Least Squares Mean
2820548|NCT00380081|Secondary|Polysomnography Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||number of awakenings||95% Confidence Interval|Least Squares Mean
2820549|NCT00380081|Secondary|Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820550|NCT00380081|Secondary|Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820551|NCT00380081|Secondary|Subjective Sleep Onset Latency After Middle-of-the-Night Awakening|Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820552|NCT00380081|Secondary|Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening|Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of time asleep||95% Confidence Interval|Least Squares Mean
2820553|NCT00380081|Secondary|Subjective Ability to Function|Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of participants|||Number
2820554|NCT00380081|Secondary|Subjective Level of Refreshed Sleep|Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of participants|||Number
2820555|NCT00380081|Secondary|Subjective Sleep Quality Rating|Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population|||percentage of participants|||Number
2820556|NCT00380081|Other Pre-specified|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820557|NCT00380081|Secondary|Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening|The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820558|NCT00380081|Other Pre-specified|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820559|NCT00380081|Secondary|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population.|||minutes||95% Confidence Interval|Least Squares Mean
2820560|NCT00380081|Secondary|Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.|Days 1 and 2 for each treatment|Intent to treat population|||participants|||Number
2820561|NCT00380081|Primary|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population|||minutes||95% Confidence Interval|Least Squares Mean
2820562|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
2820563|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
2820564|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 48|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.|||Percentage of participants|||Number
2820565|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 24|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.|||Percentage of participants|||Number
2820566|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
2820567|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
2820568|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of PH at Week 48|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 48|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
2820569|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 24|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.|||Percentage of participants|||Number
2820570|NCT00380068|Secondary|Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.|Baseline to Week 48|Full Analysis Set. Last Observation Carried forward. 25 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.|||Units on a scale||Standard Deviation|Mean
2820585|NCT00379912|Secondary|Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles||Six months|Analysis of percent apoptosis was undertaken irrespective of arm assignment and categorized between responsers and non-responders|||percentage of cells||Standard Error|Mean
2820571|NCT00380068|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 26 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.|||Units on a scale||Standard Deviation|Mean
2820572|NCT00380068|Secondary|Change From Baseline to Week 48 in WHO Functional Class|Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 48|Full Analysis Set. Observed Data. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.|||Percentage of participants|||Number
2820573|NCT00380068|Secondary|Change From Baseline to Week 24 in WHO Functional Class|Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 24|Full Analysis Set. Last Observation Carried Forward. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.|||Percentage of participants|||Number
2820574|NCT00380068|Secondary|Percent Change From Baseline to Week 48 in BNP||Baseline to Week 48|Full Analysis Set. Observed data. 111 participants were excluded from the analysis due to lack of baseline or Week 48 BNP data.|||Percent change in BNP||95% Confidence Interval|Geometric Mean
2820575|NCT00380068|Secondary|Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 10 participants were excluded from the analysis due to lack of baseline or post-baseline BNP data.|||Percent change in BNP||95% Confidence Interval|Geometric Mean
2820576|NCT00380068|Secondary|Change From Baseline to Week 48 in Borg Dyspnea Index|Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 48|Full Analysis Set. Observed data. 114 participants were excluded from the analysis due to lack of Week 48 Borg Dyspnea Index data.|||Units on a scale||Standard Deviation|Mean
2820577|NCT00380068|Secondary|Change From Baseline to Week 24 in Borg Dyspnea Index|Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline Borg Dyspnea Index data.|||Units on a scale||Standard Deviation|Mean
2820578|NCT00380068|Primary|Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline 6MWD data.|||meters||Standard Deviation|Mean
2820579|NCT00380029|Secondary|Number of Subjects Experiencing Adverse Events|The incidence of all toxicities observed during neoadjuvant and adjuvant treatment phase.Toxicity will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) 2.0.|4 weeks - 2 years following surgery|All patients enrolled received the full 4-week neoadjuvant course of erlotinib. 12 patients continued on erlotinib in the adjuvant phase for a mean (range) duration of 29 (5-84) weeks.|||Participants|||Count of Participants
2820580|NCT00380029|Secondary|Overall Survival Rate|The number of patients who remained alive and with no evidence of disease at the mean (range) follow-up of 24.8 months (3.0-36.6).|25 months||||Participants|||Count of Participants
2820581|NCT00380029|Secondary|Disease Recurrence and Progression Rates After Cystectomy|To determine disease recurrence/progression rates after cystectomy in patients treated with erlotinib|2 years||||Participants|||Count of Participants
2820582|NCT00380029|Secondary|Pathological Complete Response Rate|Determine the pathological complete response rate (P0 rate) after undergoing radical cystectomy (RC). Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 weeks||||Participants|||Count of Participants
2820583|NCT00380029|Primary|EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib|Determine the effect of neoadjuvant erlotinib hydrochloride on histopathological, molecular, and genetic correlates in patients undergoing radical cystectomy for muscle-invasive bladder cancer. Gene expression of pre-treatment and post-treatment tumor samples were analyzed to define molecular determinants of response or resistance to epidermal growth factor receptor (EGFR) inhibition. Both in vitro and in vivo EGFR-associated signatures were evaluated on pre-treatment bladder tumors. Candidate molecular determinants of sensitivity to EGFR inhibition were characterized and examined for their ability to predict sensitivity to EGFR inhibitors in vitro.|4 weeks before treatment and 4 weeks post treatment|Only patients with tumor samples with sufficient and high quality RNA were used to generate the in vivo signatures.|||fold change||Full Range|Mean
2820586|NCT00379912|Secondary|Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles||6 months|Analysis of CD34, CD71, and CD36 cells was undertaken irrespective of arm assignment.|||cells of BM (10e^6/ML)||Standard Error|Mean
2820587|NCT00379912|Secondary|Quality of Life|Data for this outcome measure was not collected or analyzed due to the termination of the study|24 months|||||||
2820588|NCT00379912|Secondary|Duration of Significant Responses|Data for this outcome measure was not collected or analyzed due to the termination of the study.|24 months|||||||
2820589|NCT00379912|Secondary|Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone|Full adverse event information is submitted in the record below. A summary of the Significant Toxicities Rate (clinically significant myelosuppression (CTCAE Grade 3 or 4 neutropenia or thrombocytopenia)) over all patients receiving at least 1 dose of study medication at the time of interim analysis is reported in this outcome measure.|24 months|All patients receiving at least 1 dose of study medication at the time of interim analysis.|||percentage of participants||90% Confidence Interval|Number
2820590|NCT00379912|Primary|Overall Response Rate After Six Cycles|"Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.~Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements."|6 months|Participants completing at least six cycles at the time of analysis.|||percentage of participants responding||90% Confidence Interval|Number
2820591|NCT00379912|Primary|Overall Response After Cycle 3|"Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.~Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements."|3 months|Participants completing at least three cycles at the time of analysis.|||percentage of participants responding||90% Confidence Interval|Number
2820592|NCT00379899|Secondary|Percent Change in Ca x P|Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
2820593|NCT00379899|Secondary|Absolute Change in Ca x P|Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||(mg/dL)2||Standard Error|Mean
2820594|NCT00379899|Secondary|Percent Change in Phosphorus|Percent change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
2820595|NCT00379899|Secondary|Absolute Change in Phosphorus|Absolute change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||mg/dL||Standard Error|Mean
2820596|NCT00379899|Secondary|Percent Change in Calcium|Percent change from baseline in corrected serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
2820597|NCT00379899|Secondary|Absolute Change in Calcium|Absolute change from baseline in serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||mg/dL||Standard Error|Mean
2820598|NCT00379899|Secondary|Percent Change in PTH|Percent change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Percentage||Standard Error|Mean
2820599|NCT00379899|Secondary|Change From Baseline of the Progression of AVC.|Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Units on a scale||Standard Error|Mean
2820600|NCT00379899|Secondary|Change From Baseline in AC Score|Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Units on a scale||Standard Error|Mean
2820601|NCT00379899|Secondary|Absolute Change in PTH|Absolute change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||pg/mL||Standard Error|Mean
2820602|NCT00379899|Secondary|Number of Participants Achieving > 15% Progression of CAC.|Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52|52 weeks|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Participants|||Number
2820603|NCT00379899|Primary|Percent Change From Baseline in CAC Score|Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score|||Units on a scale||Standard Error|Mean
2820604|NCT00379834|Primary|Diurnal Intraocular Pressure Control|Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)|12 months|Selected by level funding available|||millimeters of mercury||Standard Deviation|Mean
2820605|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Maximum Concentration (Cmax)|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Cmax in nanograms per milliliter (ng/mL).|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.|||ng/mL chloroquine||95% Confidence Interval|Median
2820606|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Time of Maximal Concentration (Tmax) and Chloroquine Half-life|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Tmax and half-life.|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.|||Hours||95% Confidence Interval|Median
2820607|NCT00379821|Secondary|Nearest Neighbor Index as a Measure of Spatial Pattern of the Distribution of Malaria Cases in Ndirande|The Global Positioning System (GPS) was used to establish the coordinates of participants' homes. The distribution of these coordinates was analyzed for evidence of clustering, or occurring closer together than would be expected on the basis of chance. Nearest Neighbor Index is a ratio of the observed mean distance over the expected mean distance. If the index is less than 1, the pattern exhibits clustering. If the index is greater than 1, the trend is toward dispersion.|1 year|The analysis included all participants for whom the GPS coordinates of the home were established.|||Index|||Number
2820608|NCT00379821|Secondary|Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.|The cumulative hazard of having a malaria attack within one year for those participants who travelled and slept in rural areas (outside the city) versus those who did not was calculated and is presented as a life table to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point. Participants are right-censored at the time of first malaria episode. Participants who did not develop malaria during follow-up or were lost to follow-up were censored at the time of their last visit.|Days 0 - 420||||participants|||Number
2820609|NCT00379821|Secondary|Number of Participants With New and Recrudescent Infections After Subsequent New Episodes|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, participants who subsequently suffered new malaria episodes were monitored for the additional occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|Day 28 to 1 year|The analysis population is limited to participants who had new episodes of malaria during the follow-up period after treatment.|||participants|||Number
2820610|NCT00379821|Secondary|Number of Participants With New and Recrudescent Malaria Infections After Initial Treatment|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, subjects were monitored for the occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|28 days to 1 year|All subjects completing the initial treatment were included in the analysis population.|||participants|||Number
2820611|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T at Recrudescent Episodes of Malaria|Participants were enrolled in the study at the time of the initial episode of malaria. If the participant presented with a subsequent episode of malaria at any time during the one year of follow-up, the presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Recrudescent episodes of malaria within one year of enrollment|The analysis population is limited to participants who presented with subsequent episodes of malaria from whom samples were successfully collected and DNA successfully amplified.|||participants|||Number
2820612|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T on Day 0 of the Initial Episode of Malaria|The presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Day 0 of initial episode of malaria|All participants from whom samples were successfully collected and DNA successfully amplified were included.|||participants|||Number
2820613|NCT00379821|Secondary|"Number of Participants in Each Treatment Arm Who Change From Normal to Abnormal on Any Questions of the Neurological Examination"|"A basic age-appropriate neurological examination was conducted on Day 28 of each malaria illness episode and also at Days 112 and 224, and at 1 year. Subjects were were counted as a change from 'normal' to 'abnormal'  if they had the 'normal' (or not-applicable) response for the initial day 28 exam and an 'abnormal' response at their last exam. If a subject did not have an exam at 1 year then the last available exam that was not associated with an illness episode (either Day 112 or 224) was used."|1 Year|Subjects who did not have an initial exam, or who did not have a subsequent exam at a routine visit are excluded.|||Participants|||Number
2820643|NCT00379808|Other Pre-specified|Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)|biomarker determined by enzyme-linked immunosorbant assay.|1 month|those completing the entire study|||pg/ml||Inter-Quartile Range|Median
2820614|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820615|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820616|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820617|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820618|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820619|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820620|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820621|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820622|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820623|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||International Units/Liter||95% Confidence Interval|Mean
2820624|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820625|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820626|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820627|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820628|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820629|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820630|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820631|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820632|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820633|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.|||Micromole/Liter||95% Confidence Interval|Mean
2820634|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.|||Grams/Deciliter||95% Confidence Interval|Mean
2820635|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.|||Grams/Deciliter||95% Confidence Interval|Mean
2820636|NCT00379821|Secondary|Number of Cases of Severe Malaria in Each Treatment Arm|A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score < 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis.|1 Year|The safety cohort includes all participants.|||Cases of severe malaria|||Number
2820637|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of fourth subsequent malaria episode (Episode 4)|This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode.|||Participants|||Number
2820638|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of third subsequent malaria episode (Episode 3)|This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode.|||Participants|||Number
2820639|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of second subsequent malaria episode (Episode 2)|This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode.|||Participants|||Number
2820640|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of first subsequent malaria episode (Episode 1)|This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode.|||Participants|||Number
2820641|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of initial malaria episode (Episode 0)|This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment.|||Participants|||Number
2820642|NCT00379821|Primary|Number of Clinical Malaria Episodes Per Year of Follow-up|Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR).|1 year|The intention to treat (ITT) population was used for the primary outcome.|||Episodes per PYAR|||Number
2820649|NCT00379795|Primary|Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24|Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.|Month 12 and 24|"Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by n"|||participants|||Number
2820650|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 12 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||letters||Standard Deviation|Mean
2820651|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||letters||Standard Deviation|Mean
2820652|NCT00379795|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.~Additional information about adverse events can be found in the adverse events section."|36 months|Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.|||participants|||Number
2820653|NCT00379795|Primary|Number of Participants With Ocular Adverse Events|"Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|36 months|All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.|||participants|||Number
2820654|NCT00379769|Secondary|Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820655|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||bone fracture events|||Number
2820656|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||bone fracture events|||Number
2820657|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820658|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820659|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820660|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820661|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820662|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820674|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820663|NCT00379769|Secondary|Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820664|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820665|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820666|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820667|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820668|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820669|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820670|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820671|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820672|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820673|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).|||participants|||Number
2820830|NCT00378014|Secondary|Incidence of the Need for a Change in the Immunosuppressive Regimen|The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).|Month 11|ITT|||Percentage of participants|||Number
2820675|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820676|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820677|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820678|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions|The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820679|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions|"The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as unknown deaths, but were counted as CV deaths for the analysis of this endpoint."|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820680|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions|Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820681|NCT00379769|Primary|Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions|IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820682|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause|All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820703|NCT00379769|Secondary|Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum|Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||partcipants|||Number
2820683|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820684|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820685|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820686|NCT00379769|Secondary|Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||mmHg (millimeters of mercury)||Standard Error|Mean
2820687|NCT00379769|Secondary|Model Adjusted Change From Baseline in Waist Circumference at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||cm (centimeters)||Standard Error|Mean
2820688|NCT00379769|Secondary|Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||U/L (Units/Liter)||95% Confidence Interval|Mean
2820689|NCT00379769|Secondary|Model Adjusted Change From Baseline in Body Weight at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||kilograms||Standard Error|Mean
2820690|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820691|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820704|NCT00379769|Secondary|Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths|The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||Number of events|||Number
2820856|NCT00377858|Primary|Hemoglobin A1c (HbA1c) at 36 Week Endpoint|Level of hemoglobin A1c at endpoint.|36 weeks|Number of participants in the per-protocol population. Last observation carried forward.|||percent HbA1c||Standard Error|Least Squares Mean
2820692|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820693|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820694|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||percent change||95% Confidence Interval|Geometric Mean
2820695|NCT00379769|Secondary|Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60|Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820696|NCT00379769|Secondary|Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||picamoles/liter (pmol/L)||Standard Error|Mean
2820697|NCT00379769|Secondary|Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||mmol/L (millimoles/Liter)||Standard Error|Mean
2820698|NCT00379769|Secondary|Model Adjusted Change From Baseline in HbA1c at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.|Baseline and Month 60 of randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||Percent||Standard Error|Mean
2820699|NCT00379769|Secondary|The Number of Participants Starting Insulin at Any Time During the Study|The number of participants starting insulin at any time during the study was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820700|NCT00379769|Secondary|Number of Participants With Addition of Third Oral Agent/Switch to Insulin|The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820701|NCT00379769|Secondary|Number of Participants With Glycaemic Failure Events|Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.|Baseline through to end of randomised dual therapy|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820702|NCT00379769|Secondary|Number of Participants With CV/Microvascular Events|The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820705|NCT00379769|Secondary|Number of Participants With Cardiovascular Events and All-cause Deaths|Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820706|NCT00379769|Primary|Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events|The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication|||participants|||Number
2820707|NCT00379639|Primary|Best Overall Response|"Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:~Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).|The Efficacy Evaluable (EE) population consisted of all patients who completed at least 2 consecutive cycles of treatment, had at least 1 post-Baseline efficacy assessment performed, and did not have any major protocol violations.|||participants|||Number
2820708|NCT00379639|Primary|Number of Participants With Adverse Events (AEs)|"AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.~A serious AE is associated with events that pose a threat to a patient's life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes."|From the date of first dose to 30 days after last dose (up to 236 days).|Safety population.|||participants|||Number
2820709|NCT00379639|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|"Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:~Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1."|28 days|Safety population - all participants who received at least one dose of study drug.|||participants|||Number
2820710|NCT00379587|Secondary|Incidence of Adverse Hematological Events|White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.|by 18 months after peripheral blood stem (PBSC) infusion||||participants|||Number
2820711|NCT00379587|Secondary|Incidence of Relapse or Progression of Disease|Percentage of participants with relapsed disease by year 4 post transplant.|by 4 years after peripheral blood stem cell (PBSC) infusion||||percentage of participants|||Number
2820712|NCT00379587|Secondary|Incidence of Grade 3 or Higher Infectious Complications||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion||||percentage of participants|||Number
2820713|NCT00379587|Primary|Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion||||percentage of participants|||Number
2820714|NCT00379574|Secondary|Number of Patients Who Experienced Adverse Events||6 months||||participants|||Number
2820715|NCT00379574|Primary|Number of Patients Who Achieved Complete Response|All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.|14 weeks||||participants|||Number
2820716|NCT00379353|Secondary|Change in Serum Cytokines and Receptors|Cytokines Levels of IL-1β and its receptor IL RA, IL-6 its receptor IL-6R, and TNF-α and its receptors (i.e. tumor necrosis factor receptor (TNFR)) of TNFR1, TNFR2, IL-10, IL-8(serum) measured at baseline, Days 15 and 29. Multiplex bead Immunoassay used to measure serum/plasma levels of IL-1, IL-6, TNF-α, IL-10, IL-8 and their receptors where assay sensitivity for the cytokines was 3-6 pg/mL. Serum IL-10, IL-1β, IL-1RA, IL-6R, sTNF-RI, sTNF-R2 were also analyzed using an enzyme-linked immunosorbent assay device. Lowering cytokine levels can decrease fatigue, increase appetite and decrease anxiety and depression.|Baseline to Day 15||||pg/mL||Inter-Quartile Range|Median
2820717|NCT00379353|Secondary|Change in Body Composition as Measured by Body Mass Index (BMI)|BMI, commonly used to measure overweight and obesity, is a measure of body fat based on a person's weight and height.|Baseline to Day 29||||kg/m^2||Full Range|Median
2820718|NCT00379353|Primary|Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)|ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline [± 3 days], 2 weeks[± 3 days] and 4 weeks [± 3 days]|Baseline to Day 29||||units on a scale||Full Range|Median
2820719|NCT00379353|Secondary|Pittsburgh Sleep Quality Index (PSQI)|PSQI measures the quality and patterns of sleep. It differentiates poor from good sleep by measuring subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A participant indicates how frequently each item was experienced on a scale from 0 to 3. The 7 component scores are then summed to obtain a global sleep score that can range from 0 to 21. A score of >/= 5 indicates poor sleepers.|Baseline to Day 29||||units on a scale||Full Range|Median
2820720|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The higher the score, the more likely the patient is showing signs of depression and as a result may benefit from a counseling/supportive session.|Baseline to Day 29||||units on a scale||Full Range|Median
2820721|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The higher the score The higher the score, the more likely the patient is showing signs of anxiety and as a result may benefit from a counseling/supportive session.|Baseline to Day 29||||units on a scale||Full Range|Median
2820722|NCT00379353|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-F consists of 27 general quality of life questions divided into 4 domains (physical, social, emotional and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4 (0= not at all, 4= very much) where the 13-item fatigue subscore totals are combined for a total of 0 to 52, with the higher number representing greater fatigue.|Baseline to Day 29||||units on a scale||Full Range|Median
2820723|NCT00379353|Secondary|Functional Assessment of Anorexia/Cachexia Therapy (FAACT)|12-item symptom-specific subscale of the FACT-G designed to measure participants' additional concerns about their anorexia/cachexia during the previous 7 days. Participant rates concerns from 0 to 4 (0= not at all, 4= very much), combined are the 12 items subscales for a total of 0 to 48 where the higher number would represent greater concern.|Baseline to Day 29||||units on a scale||Full Range|Median
2820724|NCT00379340|Secondary|Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|At 4 years|Analysis population is eligible stage (stg) IV patients (pts) with lung mets only. On Participant Flow table, these pts include 120 RCR, 135 SIR, 21 stg IV with LOH (of 52 when including stg III), and 23 stg IV with lung mets (off therapy before week 6). A total of 299 stg IV pts, exceeding the total number of participant (297) analyzed for OM 4.|||Probability||95% Confidence Interval|Number
2820725|NCT00379340|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study|At 4 years|All eligible patients were included in this analysis.|||Probability of EFS at 4 years||95% Confidence Interval|Number
2820726|NCT00379340|Primary|Event Free Survival (EFS) Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|At 4 years|Analysis includes only eligible patients.|||Probability of EFS at 4 years||95% Confidence Interval|Number
2820727|NCT00379340|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|4 years||||Probability||95% Confidence Interval|Number
2820728|NCT00379288|Primary|The Number of All Randomized Subjects Reporting Adverse Events (AEs).|AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.|1 year||||participants|||Number
2820729|NCT00379236|Secondary|Change From Baseline (Extension Study Week 26) in Use of Rescue Medication at Week 52.|The change in the number of tablets of study-specific acetaminophen taken per week as a rescue medication from knee pain.|Extension baseline (week 26 pre-dose), week 52|Intent to treat population|||tablets per week||Standard Deviation|Mean
2820730|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 52|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer:YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 52 (Extension Study)|Intent to treat population.|||participants|||Number
2820731|NCT00379236|Secondary|Mean Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Extension Study|The mean difference in participant pain as measured by participants during a walk of 50 feet in length between the baseline (week 26 pre-dose) and week 52 scores. Scores are measured on a visual analog scale of 100 millimeters, with a score of 0 millimeters meaning there was no pain observed; a score of 100 millimeters meaning extreme pain was observed.|Extension baseline (week 26), week 52|Intent to treat population. No imputation for missing values.|||units on a scale||Standard Deviation|Mean
2820732|NCT00379236|Secondary|Observed Pain Scores on the 50-foot Walk Test During the Extension Study|Participant pain during a walk of 50 feet in length was evaluated by participants on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Baseline (week 26), week 52|Intent to treat population. No imputation for missing values.|||units on a scale||Standard Deviation|Mean
2820733|NCT00379236|Secondary|Number of Participants With 20 Millimeter or Greater Improvement in Pain Scores on the 50-foot Walk Test|Yes represents the number of participants whose pain during a walk of 50 feet in length was improved at week 26 over baseline by at least 20 millimeters. Pain was evaluated on a 100 millimeter visual analog scale by participants. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0 and 26|Intent to treat population|||participants|||Number
2820734|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. The questionnaire is completed by participants. This table summarizes the change from baseline in participants' physical health.|Weeks 0, 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
2820735|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) General Health(GH) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' general health scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
2820789|NCT00378508|Secondary|Baseline Hemoglobin A1c||At baseline (before treatment)||||percentage of hemoglobin A1c||95% Confidence Interval|Least Squares Mean
2820736|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Bodily Pain(BP) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' bodily pain scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
2820737|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Function (PF) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' physical function. The questionnaire is completed by participants.|Weeks 0, 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
2820738|NCT00379236|Secondary|Change From Baseline in the Number of Tablets of Rescue Medication Used at Week 26.|The change in the number of tablets of 500 milligram acetaminophen used in a week as rescue medication is compared at weeks 0 and weeks 26.|Weeks 0 and 26|Intent to treat population|||tablets per week||Standard Deviation|Mean
2820739|NCT00379236|Secondary|Change From Baseline in Patient Global Assessment of Knee Pain at Week 26|Participant assessment of knee pain evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain.|Weeks 0 and 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
2820740|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Redness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Redness of the knee was subjectively rated as Yes (knee was red) and No (knee was not red).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
2820741|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Local Warmth at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Local warmth of the target knee was recorded as Yes (warmth present) or No (knee was not warmer than expected).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
2820742|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Tenderness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Tenderness of the knee was subjectively rated by participants as none, mild, moderate or severe.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
2820743|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Range of Motion Findings at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Range of motion indicates the flexibility of the knee, and is measured by the number of degrees between when the knee is hyper-extended and when the knee is flexed.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.|||participants|||Number
2820744|NCT00379236|Primary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the baseline (week 0) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters meaning no pain was observed; a score of 100 millimeters meaning extreme pain was observed.|Weeks 0 and 26|Intent to treat population.|||percent change from baseline value||Standard Deviation|Mean
2820745|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 26|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|week 26|Intent to treat population|||participants|||Number
2820746|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 12|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population|||participants|||Number
2820747|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 26|Intent to treat population|||participants|||Number
2820748|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 12|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population|||participants|||Number
2820749|NCT00379236|Secondary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study for a Subpopulation of Participants With More Severe Knee Pain|Percent difference in participant pain during a walk of 50 feet in length between the mean screening (week -1) and baseline(week 0) scores, and week 26 scores. Scores are recorded by participants and measured on a visual analog scale of 100 millimeters, with 0 millimeters meaning there was no pain observed; 100 millimeters meaning extreme pain was observed.|weeks -1, 0, and 26|Intent to treat population. A subpopulation of patients with more severe knee pain, as measured by having a greater than or equal to 41 millimeter screening score on the 50-foot walk test.|||percentage change from baseline score||Standard Deviation|Mean
2820750|NCT00379236|Secondary|Percent Change From Screening in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the screening (week -1) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|weeks -1 and 26|Intent to treat population|||percent change from screening value||Standard Deviation|Mean
2820751|NCT00379236|Primary|Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0, 26|Intent to treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2820752|NCT00379210|Primary|Reaction Times on the Sustained Attention to Response Task.|Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.|9 weeks||||milliseconds||Standard Deviation|Mean
2820753|NCT00379197|Secondary|Median Time to Event|First time when maximum SUV is higher than that at baseline within 1 year of study entry.|From Baseline to 1 Year|One of the 8 participants did not have an increase in SUV above baseline at 8 weeks, but no further PET scans were performed after 8 weeks. The reported median value is for the remaining 7 participants.|||weeks||Full Range|Median
2820754|NCT00379197|Primary|Disease Response|A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.|Week 4||||participants|||Number
2820755|NCT00379145|Primary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||participants|||Number
2820756|NCT00379145|Primary|Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.|Eligible and treated patients|||participants|||Number
2820757|NCT00379080|Secondary|Protein Expression Patterns Post Treatment - Loss or Gain|"serial blood samples over multiple time points (prior to treatment, 2 days post treatment, 8 days post treatment, 10 days post treatment and 28 days post treatment.~statistical analyses presented for the comparisons that yielded a p-value <=0.05"|baseline - cycle 2 (28 days)|peripheral blood was obtained from 20 patients enrolled in the phase 2 portion of the study.|||hazard ratio||95% Confidence Interval|Number
2820758|NCT00379080|Secondary|Proportion of Patients With Serious or Life Threatening Toxicities|Grade 3 or 4 toxicities related to treatment as determined by the CTCAE|2 year period||||percentage of participants|||Number
2820759|NCT00379080|Secondary|Overall Failure Rate (Phase II)|The overall failure rate is expressed as hazard of failure per person-year of follow-up.|up to 4 years||||failure per person-year||95% Confidence Interval|Number
2820760|NCT00379080|Secondary|Six-month Progression-free Survival Rate (Phase II)|"The probability of 6-momth progression-free survival will be estimated using binomial distribution.~Progression defined as: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion."|At 6 months|The probability of 6-momth progression-free survival will be estimated using binomial distribution.|||percent probability||95% Confidence Interval|Number
2820761|NCT00379080|Secondary|Overall Survival (Phase II)|Median time of survival along with 95% confidence interval will be estimated using Kaplan-Meier method. An overall failure rate will be estimated with 95% CI.|Up to 4 years|Median time of survival along with 95% confidence interval will be estimated using Kaplan-Meier method. An overall failure rate will be estimated with 95% CI. The overall failure rate is expressed as hazard of failure per person-year of follow-up.|||months||95% Confidence Interval|Median
2820762|NCT00379080|Primary|Pharmacokinetics; Steady-state Trough Concentration for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||ng/mL||Standard Deviation|Median
2820790|NCT00378508|Secondary|Baseline Insulin Use||At baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||U/kg/d||95% Confidence Interval|Least Squares Mean
2820763|NCT00379080|Primary|Pharmacokinetics; Apparent Oral Total Body Volume of Distribution for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||L||Standard Deviation|Median
2820764|NCT00379080|Primary|Pharmacokinetics; Apparent Oral Clearance for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post surgery|||L/h||Standard Deviation|Median
2820765|NCT00379080|Primary|Pharmacokinetics (Area Under the Plasma Concentration Time Profile From Zero to Infinity (AUC)) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||ng*h/mL||Standard Deviation|Median
2820766|NCT00379080|Primary|Pharmacokinetics (Apparent Terminal Phase Half-life) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||h||Standard Deviation|Median
2820767|NCT00379080|Primary|Pharmacokinetics (Max Concentration of Plasma) for Tandutinib in Phase 1 and Phase 2|pre-dose, 1,2,4,6,8 and 24 hrs post dose and days 8,15, 21 of cycle 1 and day one of cycle 2|28 days|56 enrolled pts, 40 evaluable PK sample sets, parameters not estimated for 16 pts. (Sample collected after next dose taken 3pts;1st dose given before collecting redose sample 1 pt; concentration sample 24h after dosing <LOQ 8 pts or samples not collected proper times 1pt. 2pts feasibility arm did not restart treatment post-surgery|||ng/mL||Standard Deviation|Median
2820768|NCT00379080|Primary|Tumor Response (Complete Response and Partial Response) Rate (Phase II)|"pts receive a scan baseline and prior to every odd cycle. All responses are centrally reviewed Complete response Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease Clinical status and MRI does not qualify for complete response, partial response or progression"|Up to 4 years|In the first stage, 31 patients would be enrolled and the trial would be terminated if 3 or fewer patients demonstrated objective responses (partial response or complete response)|||participants with objective response|||Number
2820769|NCT00379080|Primary|Number of Dose Limiting Toxicities Per Dose Level|"cohorts of 3-6 pts will recieve oral tandutinib starting at 500mg BID with a dose escalation in each cohort. Each treatment cycle is 28 days. Evaluation period for MTD is 1st cycle - 28 days.~dose limiting toxicity defined as: grades 3-4 severity (except vomiting and diarrhea without sufficient prophylaxis delay of treatment > 14 days. ANC less/equal 500m/mm3; Plts less/equal 25,000/mm3; febrile neutropenia or delay of treatment > 14 days"|28 days|all GBM, All prior treatment with RT. assessment was for 28 days, cycle 1. 3 dose levels 500, 600 and 700mg|||participants|||Number
2820770|NCT00379080|Primary|To Determine the Tumor/Plasma Ratio of in Subjects With Recurrent GBM Undergoing Resections (Phase 0)|participants are administered tandutinib (500mg BID) for 7 days prior to surgery and then undergo resection for recurrent glioblastoma. Tissue samples will be collected for correlative studies - determine tumor/plasma ratio.|7 days prior to surgery including surgery|a tandutinib tumor:plasma ratio of >/=0.33 was the objective in a minimum of 3/6 subjects in order to proceed with Phase 1/2 study. 6 samples received, but 2 samples were found to be thawed at receipt and not used in analysis|||ratio||Standard Deviation|Mean
2820771|NCT00379080|Primary|Maximum Tolerated Dose of Tandutinib Defined by Dose Limiting Toxicities (Phase 1)||cycle 1 - 28 days|19 patients enrolled in dose escalation but 4 were removed for reasons other than drug related toxicity|||mg BID|||Number
2820772|NCT00378898|Secondary|Subjects Reporting Chest Pain|Edmonton Symptom Assessment is used to measure the presence and change in symptoms.|48 hours|2 subjects had to have the BRAVO removed before 48 hours due to reported discomfort in the BRAVO placement group so chest pain scores were obtained for 9 of the 11 subjects.|||Participants|||Count of Participants
2820773|NCT00378898|Primary|Patients Requiring Endoscopic Removal of BRAVO Because of Reported Discomfort||48 hours||||participants|||Number
2820774|NCT00378703|Secondary|Objective Response Rate|Response was assessed using Solid Tumor Response Criteria (RECIST). Patients with complete responses or partial responses are considered having an objective response.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Proportion of patients||95% Confidence Interval|Number
2820775|NCT00378703|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death. Patients alive at last contact were censored on the date of last contact.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Months||90% Confidence Interval|Median
2820776|NCT00378703|Secondary|Proportion of Patients With Stable Disease at 6 Months|Patients whose date of progression was after 6 months or who were disease-free at last follow-up beyond 6 months were considered to be stable at 6 months and all other patients were not.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Proportion of patients||95% Confidence Interval|Number
2820777|NCT00378703|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients|||Months||90% Confidence Interval|Median
2820778|NCT00378599|Primary|A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment|Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.|24 weeks after completion of up to 48 weeks of therapy|Intent to Treat (ITT) Data Set: All enrolled subjects who received at least one dose of any study medication (PEG-Intron or Rebetol (RBV)). Analysis of all primary and secondary efficacy endpoints and safety variables was based on the ITT population.|||Participants|||Number
2820779|NCT00378573|Secondary|Overall Survival|Survival is defined as the time from the date of registration to the study to the date of death.|2 years post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.|||Month|||Number
2820780|NCT00378573|Secondary|Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)|"Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).~Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters."|1 year from start of treatment|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.|||Participants|||Number
2820781|NCT00378573|Primary|Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy||1 year post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.|||Days||95% Confidence Interval|Median
2820782|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
2820783|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
2820784|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
2820785|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.~The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
2820786|NCT00378560|Primary|Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype|Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.|Over 30 months|Includes participants who were not general protocol violators, received all 3 vaccinations, and were seronegative at Day 1 and PCR negative through Month 7 for the relevant HPV type|||Incidence per 100 person-years|||Number
2820787|NCT00378534|Secondary|Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease.||3 years maximum|||||||
2820788|NCT00378534|Primary|Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200.|Day 200||||participants|||Number
2820791|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]~For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months."|At Baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||pmol/ml||95% Confidence Interval|Least Squares Mean
2820792|NCT00378508|Secondary|Average Insulin Use Over 12 Months||After 12 months post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||U/kg/d||95% Confidence Interval|Least Squares Mean
2820793|NCT00378508|Secondary|Hemoglobin A1c||At 12 months post-treatment||||percentage of hemogloblin A1c||95% Confidence Interval|Least Squares Mean
2820794|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]~For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline."|At month 12 post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)|||pmol/ml||95% Confidence Interval|Least Squares Mean
2820795|NCT00378378|Secondary|Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine|The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).|Baseline to Endpoint||||mcg/hour||Standard Deviation|Least Squares Mean
2820796|NCT00378378|Primary|Change From Baseline 24-hour Urinary Free Cortisol Level|The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.|Baseline to Endpoint|Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed.|||mcg/hour||Standard Deviation|Least Squares Mean
2820797|NCT00378352|Secondary|Number of Participants With Clinical Events||from randomization to second CMR||||Participants|||Count of Participants
2820798|NCT00378352|Secondary|Reticulocyte Counts||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days||||percentage of red blood cells||Standard Deviation|Mean
2820799|NCT00378352|Secondary|Hemoglobin Levels||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days||||g/dL||Standard Deviation|Mean
2820800|NCT00378352|Secondary|Vital Signs||baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days||||mmHg||Standard Deviation|Mean
2820801|NCT00378352|Secondary|LV Mass Indexed to BSA||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination|||g/m^2||Standard Deviation|Mean
2820802|NCT00378352|Secondary|LV Volume Indexed to BSA||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination|||ml/m^2||Standard Deviation|Mean
2820803|NCT00378352|Secondary|LV Ejection Fraction||2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR)|Analysis only performed on subjects who completed this component of the CMR examination|||percent||Standard Deviation|Mean
2820804|NCT00378352|Secondary|Infarct Size in the Territory of the Infarct Related Artery|Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.|12 ± 2 weeks after study medication|Analysis only performed on subjects who completed the CMR examination|||percentage of LV mass||Standard Deviation|Mean
2820805|NCT00378352|Primary|Infarct Size in the Territory of the Infarct Related Artery|Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.|performed 2 to 6 days after study medication administration (first CMR)|Analysis only performed on subjects who completed the CMR examination|||percentage of LV mass||Standard Deviation|Mean
2820806|NCT00378326|Primary|Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus|Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment|through study completion, median 3 years of follow up||||months||95% Confidence Interval|Median
2820807|NCT00378326|Secondary|Cerebrospinal Fluid (CSF) Pleocytosis||White blood cell count in CSF was measured at two time points, pre- and post-treatment|"19 treatment events in 16 patients at which both pre- and post-treatment CSF samples available.~The data are reported below, separately for pre-treatment samples and post-treatment samples."|||cells/mm^3|Participants|Full Range|Median
2820808|NCT00378209|Secondary|Overall Survival|defined as time from treatment initiation to death, or last known to be alive for those who had not died|assesed at a median follow-up of 44 months||||month||95% Confidence Interval|Median
2820809|NCT00378209|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.|aassesed at a median follow-up of 44 months||||months||95% Confidence Interval|Median
2820810|NCT00378209|Secondary|Duration of Response|Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.|Assessed at a median follow-up of 44 months||||months||95% Confidence Interval|Median
2820811|NCT00378209|Secondary|Objective Response Rate|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).~Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response)."|Assessed every cycle for up to 8 cycles and best response was reported||||percentage of treated patients||90% Confidence Interval|Number
2820829|NCT00378014|Secondary|Incidence of Renal Deterioration|Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.|Baseline, Month 11|||||||
2820812|NCT00378209|Primary|The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).~Progressive disease (PD) required one or more of the following:~>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) >25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.~Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|6 months after therapy||||percentage of treated patients||90% Confidence Interval|Number
2820813|NCT00378105|Secondary|Estimated 18-month Overall Survival Rate|Overall survival was measured from treatment initiation to death, censored at the date patients were last known to be alive for those who had not died.|Survival rate at 18 months||||Percentage of participants||95% Confidence Interval|Number
2820814|NCT00378105|Secondary|Percentage of Patients Who Remained in Response for More Than 18 Months|Duration of response was measured from first response to progression or death, censored at the date patients were last known to be alive and disease free for patients who had not progressed or died.|Response rate at 18 months||||Percentage of participants||95% Confidence Interval|Number
2820815|NCT00378105|Secondary|Estimated 18-month Progression Free Survival (PFS) Rate|"PD from European Bone Marrow Transplant (EBMT) Response Criteria Required one or more:~>25% increased in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, or >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation), or >25% increased in plasma cells in a bone marrow aspirate or biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.~Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).~PFS was measured from treatment initiation to progression or death, censored at the date patients were last known to be alive and disease free"|PFS rate at 18 months|This numbers excluded 2 patients who went off study prior to start of therapy.|||Percentage of participants||95% Confidence Interval|Number
2820816|NCT00378105|Primary|Objective Response Rate of the Drug Combination in This Patient Populations.|Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.|Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant.|The numbers excluded 2 patients who went off study prior to start of therapy|||percentage of participants||90% Confidence Interval|Number
2820817|NCT00378079|Secondary|Employment|number of days employed, past 30 days-self report, assessed one year post-prison release|one year||||number of days employed, past 30||Standard Deviation|Mean
2820818|NCT00378079|Primary|Criminal Activity|self reported days of criminal activity|one year post prison release||||number of days||Standard Deviation|Mean
2820819|NCT00378079|Primary|HIV-risk Behaviors||one year|||||||
2820820|NCT00378079|Primary|Cocaine Use|cocaine urine test results-percent of participants testing positive for cocaine|one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated|||percent cocaine positive participants|||Number
2820821|NCT00378079|Primary|Heroin Use|opioid urine test results-percent of participants who were opioid-positive|results at one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated|||% participants opioid positive|||Number
2820822|NCT00378079|Primary|Treatment Retention in the Community|days in community treatment|one year post prison release||||Days in community treatment||Standard Deviation|Mean
2820823|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|Month 12 to Month 59 post-baseline|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.|||Number of participants|||Number
2820824|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|From randomization to Month 11|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.|||Number of participants|||Number
2820825|NCT00378014|Secondary|Hepatitis C Virus (HCV) Replication in HCV-positive Patients|HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).|Baseline, Month 5|ITT|||Percentage of participants|||Number
2820826|NCT00378014|Secondary|Patient and Graft Survival|Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.|Month 11|ITT|||Percentage of Participants|||Number
2820827|NCT00378014|Secondary|Incidence of Treated BPAR|The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).|Month 11|ITT|||Percentage of Participants|||Number
2820828|NCT00378014|Secondary|Renal Function (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 5|ITT|||mL/min||Standard Deviation|Mean
2820857|NCT00377832|Secondary|Rate of Neonatal Sepsis|the number of participants who developed neonatal sepsis|7 days||||participants|||Number
2820831|NCT00378014|Secondary|Incidence of Efficacy Failure|Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).|Month 11|ITT|||Percentage of participants|||Number
2820832|NCT00378014|Primary|Calculated Glomerular Filtration Rate (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 11|ITT|||mL/min||Standard Deviation|Mean
2820833|NCT00377962|Secondary|Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Participants|||Number
2820834|NCT00377962|Secondary|Mean Days of Hospitalization From Baseline to End of Study (Month 24)||Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Days||Standard Deviation|Mean
2820835|NCT00377962|Secondary|Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||%||Standard Deviation|Mean
2820836|NCT00377962|Secondary|Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||cm||Standard Deviation|Mean
2820837|NCT00377962|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Liters||Standard Deviation|Mean
2820838|NCT00377962|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Liters||Standard Deviation|Mean
2820839|NCT00377962|Secondary|Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|The intent-to-treat (ITT) population consisted of all patients as randomized, who were given at least one dose of study drug and had at least one post-baseline assessment. (Extension study)|||Participants|||Number
2820840|NCT00377962|Secondary|Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)|Number of patients not alive and number of patients with loss of their graft.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Participants|||Number
2820841|NCT00377962|Secondary|Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)|Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart & Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||Participants|||Number
2820842|NCT00377962|Secondary|Change in Serum Creatinine From Baseline to End of Study (Month 24)|Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||μmol/L||Standard Deviation|Mean
2820843|NCT00377962|Secondary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||mL/min||Standard Deviation|Mean
2820844|NCT00377962|Primary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to Month 12|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.|||mL/min||Standard Deviation|Mean
2820845|NCT00377858|Secondary|Change From Baseline in Absolute Body Weight at 36 Week Endpoint|Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.|Baseline, 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||kilograms||Standard Error|Least Squares Mean
2820846|NCT00377858|Secondary|Number of Insulin Injections Per Day||Weeks 12, 24, 30, 36|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||insulin injections||Standard Error|Least Squares Mean
2820847|NCT00377858|Secondary|Endpoint Insulin Dose; Total, Basal, and Prandial|Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||U/day||Standard Error|Least Squares Mean
2820848|NCT00377858|Secondary|Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial|Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||U/kg/day||Standard Error|Least Squares Mean
2820849|NCT00377858|Secondary|Number of Patients With at Least One Severe Hypoglycemia Episode|Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.|||participants|||Number
2820850|NCT00377858|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.|||hypoglycemic event per 30 days||Standard Deviation|Mean
2820851|NCT00377858|Secondary|Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.|||participants|||Number
2820852|NCT00377858|Secondary|Glycemic Variability|Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2820853|NCT00377858|Secondary|7-point Self-monitored Blood Glucose Profiles|Actual daily mean blood glucose levels at specified time points.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
2820854|NCT00377858|Secondary|Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint||12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).|||percentage of participants|||Number
2820855|NCT00377858|Secondary|Hemoglobin A1c (HbA1c) at Interval Visits|Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.|12, 24, and 36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.|||percent HbA1c||Standard Error|Least Squares Mean
2820864|NCT00377832|Primary|Maternal Body Temperature 90 Minutes After Randomization|Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.|90 minutes||||degrees centigrade||Inter-Quartile Range|Median
2820865|NCT00377819|Secondary|Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)|Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.|Baseline, 3 months|Participants with non-missing baseline evaluation and non-missing post-baseline evaluation at month 3.|||Percent Change||Inter-Quartile Range|Median
2820866|NCT00377819|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.|||Percent Change||95% Confidence Interval|Least Squares Mean
2820867|NCT00377819|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.|||Percent Change||95% Confidence Interval|Least Squares Mean
2820868|NCT00377741|Secondary|Plasma Half-Life (T1/2) of Ganciclovir|Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||h||Standard Deviation|Mean
2820869|NCT00377741|Secondary|Apparent Elimination Rate (Kelim) of Ganciclovir|The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||1/h||Standard Deviation|Mean
2820870|NCT00377741|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir|The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||h||Full Range|Median
2820871|NCT00377741|Primary|Maximum Observed Plasma Concentration (Cmax) of Ganciclovir|The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||μg/mL||Standard Deviation|Mean
2820872|NCT00377741|Primary|Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)|The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC [0-tau]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.|||h*mcg/mL||Standard Deviation|Mean
2820873|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.|The difference between Cycloset and placebo in the change in HbA1c from baseline to Week 24 was analyzed for subjects with a baseline HbA1c of ≥ 7.5% who were taking at least one oral hypoglycemia agent (OHA) at baseline. The primary analysis was based on subjects from the evaluable per protocol efficacy (EPPE) analysis set with a secondary analysis using subjects from the intent to treat efficacy (ITTE) analysis set for subjects completing 24 weeks of treatment. Change is reported as the absolute difference in % HbA1c.|Baseline to week 24|randomized subjects with a baseline HbA1c of >= 7.5 taking one or two oral diabetes agents (not insulin)|||percent||Standard Deviation|Least Squares Mean
2820874|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea|"Change in HbA1c from baseline to week 24 in subjects failing treatment with metformin plus a sulfonylurea with failure defined as having a baseline HbA1c value of ≥ 7.5%. Change was measured at week 24 after randomization in subjects having no major protocol violations.~Change is reported as the absolute difference in % HbA1c."|Baseline to week 24|subjects with baseline HbA1c of >= 7.5 and taking both metformin/sulfonylurea but not insulin. Analysis was conducted for those completing 24 weeks of treatment and on the ITT using the LOCF for those not completing 24 weeks of treatment.|||percent||Standard Deviation|Least Squares Mean
2820875|NCT00377676|Secondary|Number of Subjects Experiencing Serious Cardiovascular Adverse Events|The secondary safety endpoint is number subjects with occurrences of first cardiovascular SAE (myocardial infarction, stroke, in-patient hospitalization for heart failure, angina or revascularization surgery).|Baseline to week 52.|intent to treat|||Subjects|||Number
2820876|NCT00377676|Primary|Subjects Experiencing Serious Adverse Events|Number of subjects reporting all-cause Serious Adverse Events (SAEs) for usual drug therapy plus Cycloset vs. that for usual drug therapy (UDT) plus placebo from baseline to week 52.|From baseline to week 52.||||participants|||Number
2820887|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Creatinine||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||µmol/L||Standard Deviation|Mean
2820877|NCT00377637|Secondary|Maintenance Phase: Participants With Major Extra-renal Flare|A major extra-renal flare is defined as a British Isles Lupus Assessment Group (BILAG) Score category A in one extrarenal organ or three organs with concurrent category B scores. BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.|||participants|||Number
2820878|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy|The primary efficacy parameter was the time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), defined as any of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to rescue treatment for each patient. The data presented are the percentage of participants who were rescue treatment free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||Percentage of participants|||Number
2820879|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval|A proteinuric flare is defined as a doubling of the urine protein:creatinine ratio, and proteinuria ≥1 g/24 h in patients with urine protein ≤0.5 g/24 h at the end of the induction phase, or proteinuria ≥2 g/24 h if urine protein was >0.5 g/24 h at the end of the induction phase. A nephritic flare is defined as a 25% increase in serum creatinine accompanied by 1 or more of the following: (a) simultaneous doubling of the proteinuria reaching a minimum of 2 g/24 h (b) new/increased hematuria or (c) the appearance of cellular casts. All flares were adjudicated by a clinical endpoints committee.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||Percentage of participants|||Number
2820880|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine|Sustained doubling of serum creatinine concentration is defined as the first serum creatinine value that is twice the mean of the lowest 2 values from screening to end of induction, as confirmed by a second serum creatinine value obtained at least 4 weeks after the initial doubling.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||participants|||Number
2820881|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)|Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.|||participants|||Number
2820882|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths|Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN).|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.|||Deaths|||Number
2820883|NCT00377637|Secondary|Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores|The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life.|Baseline and 24 weeks|"This analysis population is intention to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||Scores on a scale||Standard Deviation|Mean
2820884|NCT00377637|Secondary|Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score|"BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK).~The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system."|Baseline, 24 weeks|Analysis population was intent to treat. The endpoint was defined using the last observation carried forward approach. If no post-Baseline value was available, endpoint was considered missing.|||Percentage of participants|||Number
2820885|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Albumin||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||g/L||Standard Deviation|Mean
2820886|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein|24-hour urine protein was measured at Baseline and Week 24.|Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."|||mg/day||Standard Deviation|Mean
2820930|NCT00377455|Secondary|Endothelin-1(ET-1) Level|From saved serum to determine Endothelian-1 (ET-1) levels in patients|16 weeks|Outcomes not available, due to early termination of study||||||
2820888|NCT00377637|Secondary|Induction Phase: Number of Participants Achieving Complete Remission|Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks.|24 weeks|Analysis population was intent to treat.|||participants|||Number
2820889|NCT00377637|Primary|Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval|Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Intent to treat analysis population which consisted of all subjects who were randomized to the maintenance phase of the study and had at least 1 maintenance efficacy assessment.|||Percentage of participants|||Number
2820890|NCT00377637|Primary|Induction Phase: Number of Patients Showing Treatment Response|Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to <3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria <3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders.|24 weeks|Analysis population was intent to treat which comprised all subjects who were randomized into the study and had at least one post-baseline efficacy assessment.|||participants|||Number
2820891|NCT00377611|Primary|Serum HI Antibody Titers for Each Influenza Strain|Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2820892|NCT00377611|Primary|Serum HI Antibody Titers for Each Influenza Strain|Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 0 (PRE)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2820893|NCT00377611|Primary|Number of Seropositive Subjects for Each Influenza Strain|A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2820894|NCT00377611|Primary|Number of Seropositive Subjects for Each Influenza Strain|A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.|At Day 0 (PRE)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2820895|NCT00377611|Primary|Number of Seroprotected Subjects Against the 3 Influenza Strains|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2820896|NCT00377611|Primary|Number of Seroprotected Subjects Against the 3 Influenza Strains|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.|At Day 0 (PRE)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2820897|NCT00377611|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2820898|NCT00377611|Primary|Number of Seroconverted Subjects for Each Influenza Strain|A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2820931|NCT00377455|Secondary|Brain Natriuretic Peptide (BNP) Level|Serum BNP level to evaluate Brain Natriuretic Peptide (BNP) level|16 weeks|Outcomes not available, due to early termination of study||||||
2820899|NCT00377611|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820900|NCT00377611|Primary|Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)|RSV infection was determined by the RT-PCR assay.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820901|NCT00377611|Primary|Number of Subjects With Fatal Outcomes|Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820902|NCT00377611|Primary|Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection|Death due to lab confirmed influenza infection was recorded during the influeza period only.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820903|NCT00377611|Primary|Number of Subjects With Influenza-related Complications|ILI complications refer to episodes of pneumonia, ischemic heart disease [HD] (unstable angina or myocardial infarction), congestive heart failure [HF], acute cerebrovascular disease [ACD] (stroke or transient ischemic attack [IA]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820904|NCT00377611|Primary|Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications|ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820905|NCT00377611|Primary|Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause|As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820906|NCT00377611|Primary|Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza|Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820907|NCT00377611|Primary|Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI|ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820908|NCT00377611|Primary|Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B|Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available|||Participants|||Count of Participants
2820909|NCT00377611|Primary|Number of Subjects With at Least One Influenza-like-infection (ILI) Episode|Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.|||Participants|||Count of Participants
2820910|NCT00377572|Secondary|Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score|"Asthma-specific quality of life (QOL) validated tool designed for children 7 to 17 years of age. PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). Actual scores ranged from 2.1 to 7.~PAQLQ scores were available for 338 of 419 (81%) of study participants, 170 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm."|Week 60|Intent-to-treat|||units on a scale||Standard Deviation|Mean
2820932|NCT00377455|Secondary|6-minute Walk Distance|The distance walked during a 6-minute walk test.|16 weeks|Outcomes not available, due to early termination of study||||||
2820934|NCT00377429|Secondary|Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||3 months|Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.|||participants|||Number
2820911|NCT00377572|Secondary|Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall Score|"Asthma-Specific Quality of Life (QOL) Measure . The PACQLQ is a validated tool that measures limitations and anxieties faced by primary caregivers of children with asthma. Scores are calculated as the mean score within two domains of questions (re: activity limitation and emotional function) and overall scores represent the mean across all questions. The use of the PACQLQ is valid for use in the caretakers of children ages 7 to 17 years of age. Higher scores indicate better quality of life. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). The range of actual scores were a minimum of 2.4 and a maximum of 7.~Method: Caretaker self-report. PACQLQ scores were available for 320 of 419 (76%) of study participant caretakers (159 in the Omalizumab (Xolair) + Conventional Therapy arm)."|Week 60|Intent-to-treat|||units on a scale||Standard Deviation|Mean
2820912|NCT00377572|Secondary|Percent Prevalence: Asthma Exacerbations|Percent participants with >=1 exacerbations. An exacerbation was defined as a prednisone burst (a minimum of 20 mg per day of prednisone, or the equivalent, taken for any 3 of 5 consecutive days) or hospitalization. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||percent prevalence|||Number
2820913|NCT00377572|Secondary|Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations|Percent participants with >=1 hospitalizations. A hospitalization is defined as an asthma-related, overnight hospitalization. . Results values are model predicted numbers,(e.g., odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||percent prevalence|||Number
2820914|NCT00377572|Secondary|Percent Prevalence: Prescribed Rescue Beta 2 Agonists|Percent of participants prescribed long-acting beta 2 agonists to maintain asthma control. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||percent prevalence|||Number
2820915|NCT00377572|Secondary|Dose Inhaled Corticosteroids (Glucocorticoids)|Prescribed dose (mcg/day) of inhaled glucocorticoids to maintain asthma control. The dose of inhaled glucocorticoids was converted to the budesonide-equivalent dose. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||mcg/day||Standard Error|Least Squares Mean
2820916|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma)|Steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone-salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at least one value was available in this period and at baseline for a participant. Results values are model predicted numbers,(e.g, odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat|||percent prevalence|||Number
2820917|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma)|Treatment steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone-salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at >/= 1 value was available in this period and at baseline for a participant; results are model predicted numbers (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat|||percent prevalence|||Number
2820918|NCT00377572|Secondary|Percent Adherence to Asthma Medication|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration every 3 months. Adherence data as an outcome were available in 384 of the 419 participants, 193 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat|||percentage of expected dose taken||Standard Error|Least Squares Mean
2820919|NCT00377572|Secondary|Exhaled Nitric Oxide|Exhaled nitric oxide is a biomarker of airway inflammation. Measurement (in parts per billion,ppb) of exhaled nitric oxide (eNO) prior to spirometry, employing a technique modified after Silkoff et al (1997) and following American Thoracic Society guidelines for eNO assessment (American Thoracic Society, 1999). Nitric oxide concentrations were measured using a rapid-response chemiluminescent analyzer (NIOX™ System, Aerocrine, Sweden) which has a response time of < 700 ms for 10-90% full scale. The Food and Drug Administration has approved this device for clinical application in asthma management. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||ppb||Standard Error|Least Squares Mean
2820933|NCT00377455|Primary|Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol.|The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication.|This will be determined after 16 weeks on the study medication.|||||||
2820920|NCT00377572|Secondary|FEV1/FVC Ratio|"The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 - 19 years of age=85%.~FEV1/FVC ratio data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant."|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Ratio (x100)||Standard Error|Least Squares Mean
2820921|NCT00377572|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|FEV1 is air volume exhaled in 1 second during spirometry. For the trial, mild asthma is defined as pre-bronchodilator FEV1 ≥80% predicted, requiring no/low-moderate dose of inhaled glucocorticoids; moderate asthma and severe asthma, respectively, as pre-bronchodilator FEV1 <80% predicted requiring the same glucocorticoids as mild asthma and FEV1 <80% predicted requiring high-dose inhaled glucocorticoids (with/without continuous oral glucocorticoids) or uncontrolled despite treatment. FEV1 % of predicted is FEV1 converted to a percentage of normal, based on height, weight, and race. FEV1 percent predicted data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Percent||Standard Error|Least Squares Mean
2820922|NCT00377572|Secondary|Asthma Control Test (ACT) Score|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients >= 12 years of age. It is a questionnaire comprised of 5 questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores were added together to calculate a total score. Total scores can range from 5 to 25. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference for ACT is 3 points. ACT scores as an outcome measure were available in 150 of the 419 participants, 77 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||ACT score||Standard Error|Least Squares Mean
2820923|NCT00377572|Secondary|Child Asthma Control Test (C-ACT) Score|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined. C-ACT scores were available as an outcome measure in 236 of the 419 participants, 118 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.|Intent-to-treat|||C-ACT score||Standard Error|Least Squares Mean
2820924|NCT00377572|Secondary|Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma|The number of work days missed by the caretaker due to the study participant's asthma was available for 138 of 419 (33%) study participant caretakers. Source of data: caretaker self-report. Data represent an average of those collected in the time period (weeks 12-60).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Days||Standard Error|Least Squares Mean
2820925|NCT00377572|Secondary|Economic Outcome: Comparison of Number of Missed School Days Due to Asthma|The number of school days missed was available for 307 of the 419 (73%) study participants, of which 152 were in the Omalizumab (Xolair) + Conventional Therapy arm. Source of data: caretaker/participant self-report. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Days||Standard Error|Least Squares Mean
2820926|NCT00377572|Primary|Maximum Number of Asthma Symptom Days|Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat|||Days||Standard Error|Least Squares Mean
2820927|NCT00377520|Secondary|Number of Participants With Adverse Events by Grade (Measures of Toxicity)|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle (up to 24 months)||||participants|||Number
2820928|NCT00377520|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 24 months)||||participants|||Number
2820929|NCT00377455|Secondary|Quality of Life (QOL)|QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).|16 weeks|Outcomes not available, due to early termination of study||||||
2820938|NCT00377429|Secondary|Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy|Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.|2 months|Full analysis population|||Participants|||Number
2820939|NCT00377429|Primary|Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days||21 days|Treated population|||Participants|||Number
2820940|NCT00377403|Primary|SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3|The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).|4 days|We analysed all participants for whom we had data at Day 3. We were unable to complete the telephone interview with 11 subjects.|||Units on a scale||Standard Deviation|Mean
2820941|NCT00377364|Secondary|Asthma Control Questionnaire|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2820942|NCT00377364|Secondary|Asthma Control Questionnaire (ACQ)|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Baseline||||units on a scale||Standard Deviation|Mean
2820943|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2820944|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Baseline||||units on a scale||Standard Deviation|Mean
2820945|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2820946|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||units on a scale||Standard Deviation|Mean
2820947|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Baseline||||units on a scale||Standard Deviation|Mean
2820948|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Baseline||||units on a scale||Standard Deviation|Mean
2820949|NCT00377364|Primary|Rey Auditory Verbal Learning Task (RAVLT)|This is a measure of declarative memory (associated with the hippocampus), using the mean number of words (0-75) recalled from Trials I-V of the RAVLT ± the standard deviation. The assessement was conducted using the same procedures as at baseline. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.|||words||Standard Deviation|Mean
2820950|NCT00377364|Primary|Rey Auditory Verbal Learning Test (RAVLT)|This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Baseline||||words||Standard Deviation|Mean
2820951|NCT00377312|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
2820952|NCT00377312|Secondary|Amino-terminal Peptides of Procollagen- 1(P1NP)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
2820953|NCT00377312|Secondary|Serum Carboxy-terminal of Collagen- 1(sCTX)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
2820954|NCT00377312|Secondary|Serum Amino-terminal of Collagen- (sNTX)|% change from baseline|baseline, daily, one week follow-up||||% change from baseline||Standard Error|Mean
2820955|NCT00377312|Secondary|Tubular Maximum for Phosphorous|mg/dl|baseline and daily||||mg/dl||Standard Error|Mean
2820956|NCT00377312|Secondary|24 Hour Urine Calcium|mg/gm creatinine|24 hours period from Day 7 to Day 8||||mg/gm creatinine||Standard Error|Mean
2820957|NCT00377312|Secondary|Fractional Excretion of Calcium|% = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)|baseline and daily||||% of excretion||Standard Error|Mean
2820958|NCT00377312|Secondary|Parathyroid Hormone (1-84)|pg/ml|baseline, daily up to Day 8 and follow-up||||pg/ml||Standard Error|Mean
2820959|NCT00377312|Secondary|1,25 Vitamin D|pg/ml|baseline, daily up to Day 8 and follow-up||||pg/ml||Standard Error|Mean
2820960|NCT00377312|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
2820961|NCT00377312|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
2820962|NCT00377312|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete||||mg/dl||Standard Error|Mean
2820963|NCT00377312|Primary|Participants With Dose Limiting Toxicity|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days||||participants|||Number
2820964|NCT00377299|Secondary|Stroop Color Word Test|The Stroop Color Word Test measures the individual's ability to separate the word and color naming stimuli thus the ability to sort information from the environment and selectively react to this information. The scoring is a measure of time to complete 100 items and the numbers of items that can be completed. THe scores are converted into T-scores which have a mean of 50 and a standard deviation of 10.|12 weeks||||T score||Standard Error|Mean
2820965|NCT00377299|Secondary|Hopkins Auditory Verbal Learning Test (HVLT)|The Hopkins Auditory Verbal Learning Test (HVLT) is a measure of cognition (memory/recall). Raw scores are derived for Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. Raw scores are calculated into T-scores. T-scores are standardized scores on each dimension for each type. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.|||T score||Standard Error|Mean
2820966|NCT00377299|Secondary|Amphetamine Use|Participant reported days per 7-day week of methamphetamine use.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.|||days per week||Standard Error|Mean
2820967|NCT00377299|Secondary|Amphetamine Craving|Visual Analog Scale (VAS) assessing Methamphetamine craving with a 1-100 scale.Higher values on the VAS scale indicate a higher Methamphetamine craving(worse outcome).|12 Weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.|||scores on a scale||Standard Error|Mean
2820968|NCT00377299|Primary|Depression Symptoms|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C), (a clinician-administered depression scale) is used to assess the severity of depressive symptoms.Scores can range from 0 to 84. The higher the score, the worse the depressive symptoms(worse outcome).|12 weeks|The intent to treat (ITT) group includes all who returned for at least one post baseline visit. Analysis uses Last Observation Carried Forward (LOCF) method.|||scores on a scale||Standard Error|Mean
2820969|NCT00377260|Primary|The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment|The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on diaries completed at home by the child's parent.|||AOM-SOS score||Standard Error|Mean
2821262|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Baseline|Intention to Treat|||ms||Standard Deviation|Mean
2820970|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the follow-up visit.|||parental satisfaction score||Standard Deviation|Mean
2820971|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the end-of-therapy visit.|||parental satisfaction score||Standard Deviation|Mean
2820972|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the on-therapy visit.|||parental satisfaction score||Standard Deviation|Mean
2820973|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits|||Number
2820974|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits|||Number
2820975|NCT00377260|Secondary|The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment|This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up.|||antibiotic prescriptions||Standard Deviation|Mean
2820976|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches <= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) & recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 & 3, & once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy||||participants|||Number
2820977|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy|The analysis was ITT. The number of participants is equal to the number of children randomized.|||participants|||Number
2820978|NCT00377260|Secondary|The Mean Number of Emergency Room Visits According to Treatment Assignment|At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits to ER||Standard Deviation|Mean
2820979|NCT00377260|Secondary|The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment|At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.|||visits to PCP||Standard Deviation|Mean
2821264|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Baseline|Intent to Treat Analysis|||words||Standard Deviation|Mean
2820980|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.|||probability of effusion||Standard Deviation|Mean
2820981|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the end-of-therapy visit.|||probability of effusion||Standard Deviation|Mean
2820982|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the on-therapy visit.|||probability of effusion||Standard Deviation|Mean
2820983|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit||Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the follow-up visit.|||participants|||Number
2820984|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the follow-up visit.|||participant|||Number
2820985|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment||End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the end-of-therapy visit.|||participants|||Number
2820986|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the end-of-therapy visit.|||participants|||Number
2820987|NCT00377260|Secondary|The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment|Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.|We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children randomized.|||participants|||Number
2820988|NCT00377260|Secondary|The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment|The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.|The first 10 days of follow-up|The analysis was ITT. The participants for analysis were the children with follow-up.|||times analgesic was administered||Standard Deviation|Mean
2820989|NCT00377260|Secondary|The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased).|Before receiving 72 hours of study medication|The analysis was ITT. The number of participants equals the number of children with follow-up whose parent(s) recorded AM and/or PM symptom scores in the first 3 days of treatment.|||Participants|||Number
2821283|NCT00374127|Primary|Plasma THC|Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.|180 minutes|Twenty four participants were included in this within-subjects analysis.|||ng/mL||Standard Deviation|Mean
2820990|NCT00377260|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on AM and PM diaries completed at home by the child's parent.|||AOM-SOS score||Standard Deviation|Mean
2820991|NCT00377260|Secondary|The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment|Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children evaluated post therapy plus the number of children who met the criteria for clinical failure prior to the end of therapy.|||participants|||Number
2820992|NCT00377260|Secondary|The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment|Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children followed at least 72 hours after the initial dose of study medication plus the number of children meeting the criteria for clinical failure less than 72 hours after the initial dose of study medication.|||participants|||Number
2820993|NCT00377234|Secondary|Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.||||||
2820994|NCT00377234|Secondary|Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.||||||
2820995|NCT00377234|Secondary|Intensity of Upper Gastrointestinal (GI) Symptoms|Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.|within 3 months|Safety analysis set|||percentage of participants|||Number
2820996|NCT00377234|Secondary|Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|within 6 months|mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment|||percentage of participants|||Number
2820997|NCT00377234|Primary|Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|at 6 months|Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment|||percentage of participants|||Number
2820998|NCT00377156|Secondary|Overall Survival|Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.|Up to 5 years|A survival comparison was performed on an intention-to-treat basis using the entire study population.|||months||Full Range|Median
2821284|NCT00374088|Post-Hoc|Urine Output|Total urine output over the first 24 hours postoperative|24 hours||||mL||Standard Deviation|Mean
2821285|NCT00374088|Post-Hoc|Max Creatinine|Maximum serum creatinine over first 3 days postoperative.|72 hours||||mg/dL||Standard Deviation|Mean
2820999|NCT00377156|Secondary|Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months|Long-Term Neurocognitive Status > To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.|From baseline to 12 months|Patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days were included in this analysis.|||percentage of participants|||Number
2821000|NCT00377156|Secondary|Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]|Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.|From Baseline to 3-Month Evaluation|All patients in the SRS and SRS+WBRT groups that had a baseline and 3-month QOL score were used in this analysis.|||QOL score change from baseline points||95% Confidence Interval|Mean
2821001|NCT00377156|Secondary|Number of Participants With Local and Distant Tumor Control up to 3 Months|Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....|Up to 3 months||||Participants|||Count of Participants
2821002|NCT00377156|Primary|Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months|The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.|3 months post radiosurgery|Patients who died prior to the 3-month evaluation, who did not return for the 3-month evaluation or a subsequent evaluation, or who did not complete the required baseline tests were excluded from the analysis population for the primary end point.|||Participants|||Count of Participants
2821003|NCT00376961|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2821004|NCT00376961|Secondary|2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of death due to any cause or last contact|0-2 years|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2821005|NCT00376961|Primary|2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2821006|NCT00376961|Secondary|Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment|All eligible patients who started treatment were included in the analysis.|||participants|||Number
2821007|NCT00376948|Secondary|pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation|Tumor tissue collected from paraffin|At start of study|||||||
2821008|NCT00376948|Secondary|Toxicity|Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9|First day of each cycle|||||||
2821009|NCT00376948|Secondary|Response Duration, Time to Treatment Failure, and Time to Progression|Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated|Every 8 weeks|||||||
2821010|NCT00376948|Secondary|Overall Objective Response Rate (Complete and Partial Response)|Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated|Every 8 weeks|||||||
2821011|NCT00376948|Primary|Median Overall Survival Estimate||up to 17 months||||months||90% Confidence Interval|Median
2821012|NCT00376948|Primary|Patients Alive||at 6 months||||participants|||Number
2821013|NCT00376935|Secondary|Number of Death From Randomization to Week 24|Number of subjects died.|From randomization to week 24||||participants|||Number
2821014|NCT00376935|Secondary|Grade 3 or 4 Lab Toxicities From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to study week 24||||participants|||Number
2821442|NCT00372775|Secondary|Overall Survival (OS)|OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.|Baseline until death (up to 1 year)|ITT. In the absence of confirmation of death, survival time was censored to last date of known contact.|||Months||95% Confidence Interval|Median
2821015|NCT00376935|Secondary|Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.|||cells/mm^3||Inter-Quartile Range|Median
2821016|NCT00376935|Secondary|Change in CT Thymic Index From Randomization|CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.|randomization, study week 12|Participants who had CT thymus evaluations at both randomization and study week 12.|||participants|||Number
2821017|NCT00376935|Secondary|Change in Naive CD4+ Cell Counts From Randomization||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. The number of participants with results available varies by study week for each treatment arm.|||cells/mm^3||Inter-Quartile Range|Median
2821018|NCT00376935|Secondary|Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to week 24|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||participants|||Number
2821019|NCT00376935|Secondary|Qualitative Hepatitis C Virus RNA||At study entry||||participants|||Number
2821020|NCT00376935|Primary|Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)|Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.|Pre-entry, entry, study week 12|Numbers presented use the intent-to-treat.|||cells/mm^3||Inter-Quartile Range|Median
2821021|NCT00376805|Secondary|Overall Median Number of Days Patients Alive After Treatment|Calculated median number of days of survival (patients alive days after treatment).|First Day of Treatment Until Death||||Days||95% Confidence Interval|Median
2821022|NCT00376805|Secondary|Number of Patients Who Died While on Study|Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.|Within 100 days, After 100 days||||Participants|||Number
2821023|NCT00376805|Secondary|Number of Patients by Disease Response|"Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:~Complete Response (CR: Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions~of clinical benefit (CB; stable disease for greater than 6 months."|6 Months, 1 Year||||Participants|||Number
2821024|NCT00376805|Primary|Number of Patients Who Had Expansion of Natural Killer Cells|Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).|Day 14||||Participants|||Number
2821025|NCT00376688|Primary|Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)|"Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.~Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;~Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits"|Up to 24 months||||percentage of participants|||Number
2821026|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."|||Units on scale||Standard Deviation|Mean
2821037|NCT00376597|Secondary|Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm|To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.|18 months|368 patients filled out a self assessment of swelling and were analyzed. This includes all patients that filled out a self-report of swelling, the two arms are combined because this is a comparison of actual swelling against self reported swelling, not a comparison of interventions.|||Participants|||Count of Participants
2821027|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."|||Units on scale||Standard Deviation|Mean
2821028|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."|||units on a scale||Standard Deviation|Mean
2821029|NCT00376675|Secondary|AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
2821030|NCT00376675|Secondary|AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4|Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
2821031|NCT00376675|Secondary|AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4|The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
2821032|NCT00376675|Secondary|AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4|Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.|||units on a scale * weeks||Standard Deviation|Mean
2821033|NCT00376675|Secondary|Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4|The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.|Baseline and Week 4|All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.|||units on a scale||Standard Deviation|Mean
2821034|NCT00376675|Primary|Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|"The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:~For those completed 4 weeks item: AUC/4;~For those completed up to week 3 item: (AUC * 4) / 3;~For those completed up to week 2 item: AUC * 2;~For those completed up to week 1 item: AUC * 4;~The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis."|Baseline to week 4|All participants meeting the eligibility criteria who have signed a consent form, started treatment, and provided a baseline and one post-baseline usual fatigue score were evaluable for this analysis.|||units on a scale||Standard Deviation|Mean
2821035|NCT00376597|Secondary|Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength|To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.|from baseline up to 18 months|236 patients were analyzed for this endpoint.|||Participants|||Count of Participants
2821036|NCT00376597|Secondary|Health-related Quality of Life as Assessed by FACT-B +4 Score|To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.|18 months|326 patients were analyzed for this measurement.|||Units on a scale||Standard Deviation|Mean
2821038|NCT00376597|Secondary|Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference|To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.|18 months|402 patients were analyzed for this endpoint.|||cubic cm||Standard Deviation|Mean
2821039|NCT00376597|Primary|Number of Participants Who Were Lymphedema-free 18 Months After Randomization|To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms|18 months|554 patients completed treatment and were analyzed.|||Participants|||Count of Participants
2821040|NCT00376558|Secondary|Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use|measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA|2x/week for 24 weeks|The number of subjects was determined from previous studies using CM/CRA|||dollars||Standard Deviation|Mean
2821041|NCT00376558|Primary|Change From Baseline in the Binding Potential of [11C]Raclopride|The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of [11C]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of [11C]raclopride, in that a negative delta BPND, or increased displacement of [11C]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.|baseline and 3 months|Analysis for change in binding potential (binding potential difference; at baseline versus stimulant induced binding potential) was done with 24 cocaine users since one of the subjects only underwent baseline scanning. However, treatment data for all 25 cocaine users was used.|||ratio||Standard Deviation|Mean
2821042|NCT00376532|Primary|MMP-9|Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment||||pg/ml||Standard Deviation|Mean
2821043|NCT00376532|Primary|MMP-2|Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment||||pg/ml||Standard Deviation|Mean
2821044|NCT00376506|Secondary|Quality of Life Patient Questionnaire|The SWAL-QOL (Swallowing Quality of Life) questionnaire was administered at baseline and every 3 months during the first year. The SWAL-QOL is a 44 item tool that measure 10 quality of life domains, i.e., food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Scores range from 0 to 100. A lower score indicates greater impairment.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
2821045|NCT00376506|Secondary|Functional Oral Intake Scale (FOIS) for Dysphagia|The FOIS was administered at baseline and every 3 months post-treatment during the first year. The FOIS is a 7 point ordinal scale reflecting the functional oral intake of patients. A score of 1 indicates no oral nutrition; a score of 7 indicates all nutrition is taken orally.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
2821046|NCT00376506|Primary|Swallowing Safety for 5 ml of Pudding|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|intention to treat|||Units on a scale||Standard Deviation|Mean
2821047|NCT00376506|Secondary|Penetration-Aspiration Scale for 5 ml Pudding|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 5 ml pudding, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
2821048|NCT00376506|Secondary|Penetration-Aspiration Scale for 10 ml Thin Liquid|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat|||units on a scale||Standard Deviation|Mean
2821049|NCT00376506|Primary|Swallowing Safety for 10 ml of Thin Liquid|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|Intention to treat|||units on a scale||Standard Deviation|Mean
2821257|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis|||words||Standard Deviation|Mean
2821050|NCT00376363|Secondary|Visual Acuity|Snellen chart converted to logMAR (smaller logMAR values indicate better visual acuity logMar of 0 is Snellen 20/20; logMAR of 20/200 is 1.0)|5 years|"The failure rate is based on Kaplan Meier analysis of all patients enrolled (n=276).~The five-year intraocular pressure and visual acuity outcomes are based on those patients who received a five-year visit (n=174 for IOP; n=173 for visual acuity, 1 patient had missing data)"|||logMAR||Standard Deviation|Mean
2821051|NCT00376363|Primary|Failure Rate|5-year failure rate measured by Kaplan-Meier, defined as IOP>21 mm Hg or less than a 20% reduction below baseline on 2 consecutive study visits after 3 months, reoperation for glaucoma, loss of light perception, or removal of implant|5 years|Kaplan-Meier survival analysis|||percent fail|||Number
2821052|NCT00376363|Primary|Intraocular Pressure|intraocular pressure mmHg at 5 years|5 years||||mm Hg||Standard Deviation|Mean
2821053|NCT00376259|Secondary|Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough|The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.|Week 96||||Proportion of Participants|||Number
2821054|NCT00376259|Secondary|Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria|Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.|12 week, 24 week, 48 week and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint.|||Percentage of participants|||Number
2821055|NCT00376259|Secondary|Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration|Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.|Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation.|||Log10 Copies/mL||Standard Deviation|Mean
2821056|NCT00376259|Primary|The Proportion of Participants Who Experienced Virologic Breakthrough|Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.|96 Weeks|This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.|||Proportion of participants|||Number
2821057|NCT00376246|Secondary|Lipid Profile- Change in LDL(Low Density Lipoprotein)||before food, 3 hours post prandial, 6 hours postprandial|The results are reported for ezetimibe and placebo irrespective of order of administration, (there was a washout period of 4-6)|||mg/dl||Standard Deviation|Mean
2821058|NCT00376246|Primary|Percent Change in Flow Mediated Dilation||before food, 3 hours postprandially and 6 hours postprandially||||percent change||Standard Deviation|Median
2821059|NCT00376220|Primary|Mean Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to the End of 8 Weeks of Therapy.|The Montgomery Asberg Depression Rating Scale measures symptoms of depression (MADRS) is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions with a fixed 7 point scale (0-6). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response will be defined as a > 50% reduction in MADRS score from baseline.|8 weeks|Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.|||units on a scale||Standard Deviation|Mean
2821060|NCT00376168|Other Pre-specified|Change in Chitotriosidase|Change in Chitotriosidase from Baseline to Month 9|Baseline and Month 9|Intent to treat|||nmol/ml/hr||Standard Deviation|Mean
2821061|NCT00376168|Secondary|Change in Platelet Count|Change in Platelet count from Baseline to Month 9|Baseline and Month 9|Intent to treat|||count/mm^3||Standard Deviation|Mean
2821062|NCT00376168|Secondary|Change in Hemoglobin|Absolute change in Hemoglobin concentration from Baseline to Month 9|Baseline and Month 9|Intent to treat|||g/dL||Standard Deviation|Mean
2821063|NCT00376168|Secondary|Change From Baseline in Liver Volume|Calculated as percent change in liver volume from Baseline to 9 months|Baseline and 9 months|Intent to treat|||percentage of change from baseline||Standard Deviation|Mean
2821064|NCT00376168|Primary|Change From Baseline in Spleen Volume Measured by MRI.|Calculated as percent change in spleen volume from Baseline to 9 months|Baseline and 9 months|Intent to treat|||percentage of change||Standard Deviation|Mean
2821065|NCT00375999|Primary|Overall Survival||One year||||month||95% Confidence Interval|Median
2821066|NCT00375973|Secondary|Number of Participants Who Discontinued Use of Treatment Due to Adverse Events|Paticipants who dropped out of the study because of intolerable adverse events.|Any time after randomization up to 12 weeks.|One patient in the duloxetine group did not have post-baseline data.|||participants|||Number
2821067|NCT00375973|Secondary|Number of Participants Who Discontinued the Study for Any Reason|Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.|Any time after randomization up to 12 weeks.||||participants|||Number
2821263|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Endpoint (12 weeks)|Intent to Treat Analysis|||words||Standard Deviation|Mean
2821068|NCT00375973|Secondary|Patient Global Impression of Improvement (PGI-I)|Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.|baseline to endpoint at 12 weeks.|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
2821069|NCT00375973|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S)|Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
2821070|NCT00375973|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale|The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
2821071|NCT00375973|Secondary|Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score|The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 [no pain] to 10 [pain as bad a you can imagine] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
2821072|NCT00375973|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score|"The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.~The general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit."|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.|||units on a scale||Standard Deviation|Mean
2821073|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge.|Day 3||||participants|||Number
2821074|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2||||participants|||Number
2821075|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1||||participants|||Number
2821076|NCT00375934|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).|||minutes||95% Confidence Interval|Median
2821077|NCT00375934|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose||||participants|||Number
2821078|NCT00375934|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hourse post single dose||||units on a scale||Standard Deviation|Mean
2821079|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4).~Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results)."|||minutes||95% Confidence Interval|Median
2821080|NCT00375934|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
2821081|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).|||minutes||95% Confidence Interval|Median
2821082|NCT00375934|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
2821083|NCT00375934|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy||||units on a scale||Standard Deviation|Mean
2821084|NCT00375830|Secondary|Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI|Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion.|30 days||||lesions|||Number
2821085|NCT00375830|Secondary|Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI|Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion.|30 days||||Participants|||Count of Participants
2821086|NCT00375830|Secondary|Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy|Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.|30 days||||percentage of participants|||Number
2821087|NCT00375830|Secondary|Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI|Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.|30 days||||percentage of participants|||Number
2821088|NCT00375830|Secondary|Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions|Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.|30 days||||percentage of participants|||Number
2821089|NCT00375830|Secondary|Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions|Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.|30 days|For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.|||percentage of particpants|||Number
2821090|NCT00375830|Secondary|Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions|"Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI).~Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants.~PPV is the probability that participants with a positive screening test truly have the disease.~Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined.~Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection."|30 days|For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.|||percentage of particpants|||Number
2821091|NCT00375830|Secondary|Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT|The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion.|30 days|"This assessment was conducted only for Cohort 1 as part of the pilot phase of the study. Only participants with both medically-evaluable scans are included."|||Participants|||Count of Participants
2821092|NCT00375830|Secondary|Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT|The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was > 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or < 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.|30 days|"This assessment was conducted only for Cohort 1 as part of the pilot phase of the study. Only participants with medically-evaluable results for both scans are included."|||Participants|||Count of Participants
2821093|NCT00375830|Secondary|Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT|"The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was > 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or < 18F-NaF PET/CT. The outcome result is represented as a number without dispersion.~8 analyzed 5 2~1"|30 days|"This assessment was conducted only for Cohort 1 as part of the pilot phase of the study. Only participants with medically-evaluable results for both scans are included."|||Participants|||Count of Participants
2821094|NCT00375830|Secondary|Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT|The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.|30 days|"This assessment was conducted only for Cohort 1, and only for participants with skeletal metastases, as part of the pilot phase of the study."|||Participants|||Count of Participants
2821095|NCT00375830|Primary|Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy|"The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF > 99mTc-MDP), the same between both scans (18F-NaF = 99mTc-MDP), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF < 99mTc-MDP)."|30 days|"This assessment was conducted only for Cohort 1 as part of the pilot phase of the study."|||Participants|||Count of Participants
2821096|NCT00375752|Secondary|Mean Changes From Baseline in FACT-B Total Score at 6 Months (ITT, Data as Observed)|"The FACT-B total score is calculated by summing all five unweighted subscale scores, with total scores in the range of 0-144.To Derive a FACT-B total score: all sections added together The higher the score the better the QoL~+ __________ + __________ + __________ + __________ =________=FACT-B Total score (PWB score) (SWB score) (EWB score) (FWB score) (BCS score)"|baseline and 6 mos|ITT|||score on a scale||Standard Deviation|Mean
2821097|NCT00375752|Secondary|Change From Baseline in Tumor Size (Longest Diameter) at Month 6|Tumor size (sum of longest diameter)was analyzed based on the diameters values provided with the central review.|Baseline, Month 6|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.|||cm||Standard Deviation|Mean
2821098|NCT00375752|Secondary|Number of Patients With Breast Conserving Surgery at 6 Months||Every 6 months|The intent-to-treat (ITT) population included all patients of the safety population for whom at least one post-baseline assessment of tumor response according to the modified RECIST (local or central assessment) was available. During different time points, participants with observations at that timepoint were included in the analysis.|||Participants|||Number
2821099|NCT00375752|Secondary|Best RECIST Response Based on Central Review at 6 Mos|Best response is defined as the best response the patients has reached during the 6 months of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet criteria.|6 Months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.|||Participants|||Number
2821100|NCT00375752|Primary|Tumor Response Rate (Complete Response (CR) or Partial Response (PR)) Based on MRI- or Mammography and/or Sonography According to Modified RECIST Criteria at Month 6|Sum of longest diameter for all target lesions was reported as baseline sum LD. Baseline sum LD was used as reference to characterize objective tumor response. Response Evaluation Criteria in Solid Tumors has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response)= 30% decrease in sum of longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD(stable disease)=small changes that do not meet criteria. Analysis was underpowered due to insufficient recruitment rate.|6 months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.|||percentage of participants||95% Confidence Interval|Number
2821101|NCT00375713|Secondary|Global Improvement at Endpoint During the 14 Day Treatment Period|Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values.|||Participants|||Number
2821102|NCT00375713|Secondary|Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period|Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.|||Units on a scale||Standard Error|Mean
2821103|NCT00375713|Secondary|Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period|The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.|Baseline and at endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.|||Units on a scale||Standard Error|Mean
2821258|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis|||words||Standard Deviation|Mean
2821104|NCT00375713|Primary|Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).|A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.|Day 7 and 14|The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors.|||Participants|||Number
2821105|NCT00375674|Secondary|Number of Participants With Tolerability Symptoms|"Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later.~The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row."|"Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later"|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Number of participants|||Number
2821106|NCT00375674|Secondary|PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ‑VAS) Observed Means|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a different drug from that to which they were randomized. Here, ‘Number analyzed’ signifies the number of participants evaluable at specified time-points.|||Units on a scale||Standard Error|Mean
2821107|NCT00375674|Secondary|PROs- EuroQoL EQ‑5D Observed Means - Intent to Treat Population|Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, & anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, & 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from −0.594 to 1; low scores represented a higher level of dysfunction & 1 as perfect health.|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a different drug from that to which they were randomized. Here, ‘Number analyzed’ signifies the number of participants evaluable at specified time-points.|||Units on a scale||Standard Error|Mean
2821108|NCT00375674|Secondary|PROs- EORTC QLQ‑C30: Symptom Scale Scores Between Treatment Comparison|"PROs assessed health-related QoL by using the EORTC QLQ-C30, which was a 30 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from not at all to very much to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms."|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Scores on scale||95% Confidence Interval|Mean
2821109|NCT00375674|Secondary|PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison|"Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale & 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning). The questionnaire includes 28 items with 4-point Likert type responses from not at all to very much to assess functioning; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL."|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Scores on scale||95% Confidence Interval|Mean
2821128|NCT00375505|Secondary|Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24|Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
2821259|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Endpoint (12 weeks)|Intent to Treat Analysis|||units on a scale||Standard Deviation|Mean
2821110|NCT00375674|Secondary|Patient‑Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores|"Patient‑reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale, 5 multi-item functional scales (physical, role, emotional, cognitive, & social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, & pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, & the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from not at all to very much to assess functioning & symptoms; 2 items with 7-point Likert scales for global health & overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL & more severe for symptoms."|Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a different drug from that to which they were randomized. Here, ‘Number analyzed’ signifies the number of participants evaluable at specified time-points.|||Scores on scale||Standard Error|Mean
2821111|NCT00375674|Secondary|Summary of Duration of Treatment‑Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)|"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.~Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later.~The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent."|"Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later"|"AT population: All participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.~The numbers of participants analyzed were the participants with any adverse event of special interest (AESI) and that one participant could have reported more than one AESI"|||Weeks||Standard Deviation|Mean
2821112|NCT00375674|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity|"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.~Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent."|"Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later"|The As-Treated (AT) population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.|||Number of participants|||Number
2821113|NCT00375674|Secondary|Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)|OS was defined as the time from the date of randomization to the date of death due to any cause.|Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Year||95% Confidence Interval|Median
2821114|NCT00375674|Primary|DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]|"DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites.~Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses.~Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent.~According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized."|Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Number of years||95% Confidence Interval|Median
2821129|NCT00375505|Secondary|Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24|CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/mL||Standard Deviation|Mean
2821361|NCT00373360|Secondary|Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2821115|NCT00375674|Primary|Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review|DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.|Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Number of years||95% Confidence Interval|Median
2821116|NCT00375609|Secondary|Incidence of Adjudicated Pulmonary Embolism (PE) and All Deep Vein Thrombosis (DVT) (Proximal and Distal)|Incidence of adjudicated pulmonary embolism (PE) and all deep vein thrombosis (DVT) (proximal and distal) through the time of venography on Day 10 to 14 and at follow-up at approximately 6 (±2) weeks after TKR surgery|At follow-up at approximately 6 (±2) weeks after TKR surgery|All randomized patients who took at least 1 dose of study medication after randomization and for whom an evaluable venogram was available|||Percentage of Participants||95% Confidence Interval|Number
2821117|NCT00375609|Primary|Incidence of Adjudicated Overt Bleeding Events: Primary Safety Endpoint|The incidence of adjudicated major and clinical relevant non-major bleeding. Major bleeding was defined as fatal, involving vital organs, requiring additional surgery or a new therapeutic procedure, or a bleeding index >=2. Bleeding Index was defined as the number of units of packed red blood cells or whole blood transfused plus the haemoglobin values before the bleeding episode minus the haemoglobin values after the bleed had stabilized (in g/dL)|Through follow-up at approximately 6 (±2) weeks after TKR surgery|All randomized patients who took at least 1 dose of study medication after randomization.|||Percentage of Participants||95% Confidence Interval|Number
2821118|NCT00375609|Primary|Incidence of Adjudicated Venous Thromboembolism (VTE)|Incidence of adjudicated venous thromboembolism (VTE) through Day 10-14 following TKR where VTE is defined as DVT (proximal and/or distal) and/or PE. Patients were evaluated for VTE daily while hospitalized and were contacted every 2 to 4 days after discharge and before the day of the mandatory venogram to monitor for study endpoints|Through Day 10-14 following TKR surgery, at time of mandatory venogram|All randomized patients who took at least 1 dose of study medication after randomization and for whom an evaluable venogram was available|||Percentage of Participants||95% Confidence Interval|Number
2821119|NCT00375518|Primary|Determine the Postoperative Complications Found in Each Group|To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.|one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery||||participants|||Number
2821120|NCT00375505|Secondary|Change in Inhibin A and Inhibin B From Baseline to Month 24|Change in Inhibin A and Inhibin B from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||pg/ml||Standard Deviation|Mean
2821121|NCT00375505|Secondary|Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24|Change in anti-Mueller hormone (AMH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
2821122|NCT00375505|Secondary|Change in Vitamine D From Baseline to Month 24|Change in Vitamine D from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
2821123|NCT00375505|Secondary|Change in Parathyroid Hormone (PTH) From Baseline to Month 24|Change in Parathyroid Hormone (PTH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||pg/ml||Standard Deviation|Mean
2821124|NCT00375505|Secondary|Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24|Change in Sex Hormone binding globulin (SHGB) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||nmol/l||Standard Deviation|Mean
2821125|NCT00375505|Secondary|Change in Testosterone From Baseline to Month 24|Change in Testosterone from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/ml||Standard Deviation|Mean
2821126|NCT00375505|Secondary|Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24|Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||mIU/ml||Standard Deviation|Mean
2821127|NCT00375505|Secondary|Change in Estradiol (E2) From Baseline to Month 24|Change in Estradiol from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||ng/L||Standard Deviation|Mean
2821144|NCT00375492|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.|baseline, Week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
2821130|NCT00375505|Secondary|Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)|Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||m/s||Standard Deviation|Mean
2821131|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||dB/MHz||Standard Deviation|Mean
2821132|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||m/s||Standard Deviation|Mean
2821133|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||percentage change||Standard Deviation|Mean
2821134|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||Percentage Change||Standard Deviation|Mean
2821135|NCT00375505|Primary|Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||percentage change||Standard Deviation|Mean
2821136|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||Z-score||Standard Deviation|Mean
2821137|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score|Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||T-score||Standard Deviation|Mean
2821138|NCT00375505|Primary|Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24|Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.|||Z-score||Standard Deviation|Mean
2821139|NCT00375492|Secondary|Rate of Hypoglycemic Events|Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).|24 weeks|Intent to Treat population|||events per patient per year||Standard Error|Least Squares Mean
2821140|NCT00375492|Secondary|Number of Participants With Hypoglycemic Events During the Study|Number of participants experiencing one or more events of hypoglycemia at any point in the study|Baseline to 24 weeks|Intent to Treat population|||participants|||Number
2821141|NCT00375492|Secondary|Ratio of Triglycerides at Week 24 to Triglycerides at Baseline|Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.|baseline, Week 24|Intent to Treat population|||Ratio||Standard Error|Geometric Mean
2821142|NCT00375492|Secondary|Change From Baseline in Total Cholesterol at Week 24|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.|baseline, week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
2821143|NCT00375492|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24|Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L|baseline, Week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
2821145|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline|Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population|||Ratio||Standard Error|Geometric Mean
2821146|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline|Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population|||Ratio||Standard Error|Geometric Mean
2821147|NCT00375492|Secondary|Change From Baseline in Waist Circumference at Week 24|Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).|baseline, Week 24|Intent to Treat population|||cm||Standard Error|Least Squares Mean
2821148|NCT00375492|Secondary|Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24|Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).|baseline, Week 24|Intent to Treat population|||mmol/L||Standard Error|Least Squares Mean
2821149|NCT00375492|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.|baseline, Week 24|Intent to Treat population|||percent hemoglobin||Standard Error|Least Squares Mean
2821150|NCT00375492|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).|Baseline, Week 24|Intent to Treat population|||kg||Standard Error|Least Squares Mean
2821151|NCT00375427|Secondary|Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score|ECOG Performance Score has 4 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. Outcome is given as median score for participants at Baseline and 3, 6 , 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.|||score on a scale||Full Range|Median
2821152|NCT00375427|Secondary|Use Of Analgesic Medications According to the Analgesic Score Scale|"The analgesic score used for this study is modified from the Radiation Therapy Oncology Group (RTOG) analgesic score scale. The scale represents type of medication administered from 0 to 4 where:~0 = None~= Minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.)~= Tranquilisers, antidepressants, muscle relaxants, and steroids~= Mild narcotics (oxycodone, meperidine, codeine, etc.)~= Strong narcotics (morphine, hydromorphone, etc.) The outcome is given a the median score for the participants at Baseline and 3, 6, 9 and 12 months of treatment"|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.|||score on a scale||Full Range|Median
2821153|NCT00375427|Secondary|Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value|Pain intensity at rest and on movement is rated by the patient by means of a validated 6-point Verbal Rating Scale (VRS) and refers to the pain which occurred during the last week before the assessment. Median score value is the median of all the observed scores (none=0, very mild=1, mild=2, moderate=3, severe=5 and very severe=6) at each time point.|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.|||score on a scale||Full Range|Median
2821154|NCT00375427|Secondary|Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire|Bone pain was assessed by means of a pain score obtained using the Brief Pain Inventory (BPI) questionnaire. The BPI can produce three pain scores: worst pain, a composite pain score, and a pain interference score. The composite pain score, which is the average of questions 3, 4, 5 and 6 of the questionnaire was used in this study. Pain was rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The outcome is given as the median score for participants at baseline, and 3, 6, 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients. All ITT patients with BPI questionnaire filled up at baseline were included.|||score on a scale||Standard Deviation|Mean
2821155|NCT00375427|Secondary|Percentage of Participants Skeletal Related Event (SRE) Free|"Percentage of participants SRE free is defined as the Kaplan-Meier estimate of participants free of any Skeletal Related Events(SRE) at each time point.~Skeletal Related Events (SREs) are:~pathologic bone fracture; non-vertebral and vertebral~spinal cord compression identified by X-rays~surgery to bone both curative and prophylactic~radiation therapy to bone (palliative, therapeutic or prophylactic)~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level which is symptomatic and requires treatment other than rehydration."|12 months|Intent-to-treat (ITT) population will include all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2821156|NCT00375427|Secondary|Median Time to First Skeletal Related Event(s) (SRE)|Median Time to first skeletal related event (SRE) is defined as the time from randomization to the date of first occurrence of any SRE which includes at least one of the following: radiation therapy to bone, pathologic bone fracture, spinal cord compression, surgery to bone, and hypercalcemia of malignancy (HCM). Due to the few numbers of SRE, Kaplan-Meier estimate never reaches a failure probability >=25%; so median time, 25th and 75th percentiles are not determined.For this reason only the estimated percentage of patient SRE free are reported at each time point.|12 month||||Day|||Number
2821157|NCT00375427|Secondary|Annual Incidence of Any Skeletal Related Events (SREs)|"Skeletal Related Events (SREs) are defined as a:~pathologic bone fracture such as non-vertebral and vertebral~spinal cord compression identified by X-rays evidence~surgery to bone both curative and prophylactic~radiation therapy to bone including palliative, therapeutic or prophylactic~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration. Annual incidence for each SRE was computed in the same way as annual overall SMR."|12 months|Intent-to-treat (ITT) population will include all randomized patients.|||Number of SRE per Year||Standard Deviation|Mean
2821158|NCT00375427|Secondary|Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)|"Skeletal Related Events (SREs) are defined as a:~pathologic bone fracture such as non-vertebral and vertebral compression fractures~spinal cord compression identified by positive diagnosis documented by X-ray evidence~surgery to bone both curative and prophylactic~radiation therapy to bone including palliative, therapeutic or prophylactic~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration."|12 month|Intent-to-treat (ITT) population will include all randomized patients.|||Percentage of Participants|||Number
2821159|NCT00375427|Primary|Annual Overall Skeletal Morbidity Rate (SMR)|"The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio days of observation period / 365.25, for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.~SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit."|12 months|Intent-to-treat (ITT) population will include all randomized patients.|||Number of Skeletal Events per Year||Standard Deviation|Mean
2821160|NCT00375219|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
2821161|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
2821162|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response|||months||Full Range|Median
2821163|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response|||months||Full Range|Median
2821164|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.~Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|up to 3 years|Intent to treat|||months||95% Confidence Interval|Median
2821165|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat|||months||95% Confidence Interval|Median
2821166|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to 22 months|Intent to treat population of participants who had a cytogenetic response|||treatment cycles||Full Range|Median
2821167|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment|||treatment cycles||Full Range|Median
2821168|NCT00375219|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL|||percentage of participants||95% Confidence Interval|Number
2821186|NCT00374868|Secondary|Progression-Free Survival|Defined as the time from study enrollment until disease progression or death from any cause.|baseline to measured progressive disease (up to 620 days)|11 patients were censored|||days||95% Confidence Interval|Median
2821169|NCT00375219|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).~Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~The percentage of participants achieving response with extramedullary disease at Baseline was to be summarized, if the sample size was sufficient. This analysis was not done as the sample was ultimately insufficient"|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline. Analysis not performed due to insufficient sample size.||||||
2821170|NCT00375219|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)~Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.~Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.~Partial Response - CHR plus one or more of the following:~Persistence of splenomegaly with a reduction of ≥50% from pre-treatment~Platelets > 450*10^9/L~Presence of immature cells in the peripheral blood~5% to 25% blasts in the bone marrow~If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat|||percentage of participants|||Number
2821171|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
2821172|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.|||percentage of participants||95% Confidence Interval|Number
2821173|NCT00375219|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:~Complete: 0% Ph+ cells~Partial: >0%-35% Ph+ cells~Minor: >35%-65% Ph+ cells~Minimal: >65%-95% Ph+ cells~No Response: >95% Ph+ cells~Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat|||percentage of participants|||Number
2821174|NCT00375219|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.~Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug.~Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.~A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 3 years|Intent to treat|||participants|||Number
2821175|NCT00375219|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.~Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2821187|NCT00374868|Secondary|Time to Treatment Failure (TTF)|Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed.|baseline to stopping treatment (up to 620 days)|1 patient was censored|||days||95% Confidence Interval|Median
2821188|NCT00374868|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|baseline to measured progressive disease (up to 620 days)|19 patients were censored|||days||Standard Error|Mean
2821176|NCT00375219|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population|||percentage of participants||95% Confidence Interval|Number
2821177|NCT00375167|Primary|Quality of Life Index, General Version|The Quality of Life Index, General Version (37), is a 33-item self-report scale measuring satisfaction with and importance of aspects of life. It includes four subscales: health and functioning, socioeconomic status, psychological status, and significant others. Satisfaction and importance are measured on a 6-point agreement scale. A high score indicates higher quality of life. Full scoring instructions and computer algorithm is available at http://qli.org.uic.edu/questionaires/pdf/genericversionIII/genericscoring.pdf. Importance ratings are used to weight satisfaction responses so that scores reflect satisfaction with aspects of life that are valued by the individual (37). For internal consistency and reliability, Cronbach's alpha is .92 for the entire tool and .88, .75, .80, and .68, respectively, for the subscales (37). Possible range for the final scores = 0 to 30, where a higher value represents a better outcome..|Within 3 days of completion of intervention||||units on a scale||Standard Deviation|Mean
2821178|NCT00375167|Primary|Recovery Assessment Scale|The construct is Personal Recovery, defined as a person's ability to live a full and meaningful life. The Recovery Assessment Scale (RAS) has 41-items and uses a 5-point agreement scale, and a total score is used, with scores ranging from 41-205, with a higher score indicating a higher sense of personal recovery. The RAS also has 5 subscales (see below). Subscales are added to produce a total score. Domain 1 is Confidence and Hope. he scoring range here is 9-45, where a higher score indicating higher recovery. Domain 2 is Willingness to Ask for Help. Scoring range is 3-15. Domain 3: Ability rely on others: Scoring range 5-25. Domain 4 Symptoms: Scoring range 4-20. Domain 5: Goal and Success Orientation: Scoring range 3-15. For each domain, higher values represent a better outcome.|Within 3 days of completion of intervention||||units on a scale||Standard Deviation|Mean
2821179|NCT00375167|Primary|Empowerment Scale|The construct measured is empowerment. The Empowerment Scale is a self-reported measure that contains 28 statements about empowerment to which participants respond on a 4-point agreement scale. Scoring range is 28-112, with a lower score indicating higher empowerment. Studies have demonstrated the scale's high internal consistency ({alpha}=.85-.90) and good reliability ({alpha}>.60) and validity (28,31,32).|Within 3 days of completion of interventions||||units on a scale||Standard Deviation|Mean
2821180|NCT00375167|Primary|Hope Herth Index|"The Herth Hope Index was used to gather information about participants' level of hopefulness. The 12-item scale is easily administered and has been used with persons with serious mental illness . It is a self-report tool, and respondents answer on a 4-point agreement scale that ranges from strongly disagree to strongly agree. The scoring range is from 12-48 with a higher score indicating higher levels of hope. The scale has been shown to have an alpha coefficient of .97 and a test-retest reliability of .91 within two weeks. Criterion-related validity has also been supported by high correlations (.81-.92) with instruments measuring the same construct."|Within 3 days of completion of intervention||||units on a scale||Standard Deviation|Mean
2821181|NCT00374907|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|116 weeks|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.|||participants|||Number
2821182|NCT00374907|Other Pre-specified|Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|116 weeks|Treated participants|||participants|||Number
2821183|NCT00374907|Secondary|Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized Participants with both a baseline and post-baseline value (up to Week 12).|||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
2821184|NCT00374907|Primary|Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized participants with both a baseline and post-baseline value (up to Week 12).|||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
2821185|NCT00374868|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 620 days)|20 patients were censored.|||days||Standard Error|Mean
2821189|NCT00374868|Secondary|Duration of Stable Disease|Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.|time of no response or progression (up to 620 days)|1 patient was censored.|||days||95% Confidence Interval|Median
2821190|NCT00374868|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|time of response to progressive disease (up to 620 days)|10 patients were censored.|||days||Standard Error|Mean
2821191|NCT00374868|Secondary|Time to Response|Defined as time from study enrollment to the first Complete Response or Partial Response (using RECIST criteria). Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|baseline to response (up to 620 days)|16 patients were censored.|||days||Standard Error|Mean
2821192|NCT00374868|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 620 days)||||participants|||Number
2821193|NCT00374842|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.|From study start to study end, from Day 0 to Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2821194|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.|Within the 30-day follow-up period (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2821195|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2821196|NCT00374842|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2821197|NCT00374842|Primary|Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2821198|NCT00374842|Primary|Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subject|||Number
2821199|NCT00374842|Primary|Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.|A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subject|||Number
2821200|NCT00374842|Primary|Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||HIU||95% Confidence Interval|Geometric Mean
2821201|NCT00374803|Secondary|GI Toxicities|Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)|12 months||||participants|||Number
2821202|NCT00374803|Secondary|Incidence of Post Transplant Infections|Incidence of post transplant infections that resulted in hospitalization|12 months||||participants|||Number
2821203|NCT00374803|Secondary|Renal Function at 12 Months|Renal function measured by serum creatinine (SCr) at 12 months post-transplant|12 months||||mg/dL||Standard Deviation|Mean
2821204|NCT00374803|Secondary|Patient and Allograft Survival 12 Months|Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.|12 months||||participants|||Number
2821205|NCT00374803|Primary|Incidence of All Biopsy Proven Acute Rejection.|Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine|12 months||||Participants|||Number
2821206|NCT00374556|Secondary|Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale|The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Joint Stiffness was assessed on a VAS scale of 0-20, with 0 being no joint stiffness, and 20 being maximum stiffness.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821207|NCT00374556|Secondary|Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary|The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Mental Component Summary was used here as a global index of mental health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821208|NCT00374556|Secondary|Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary|The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Physical Component Summary was used here as a global index of physical health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821209|NCT00374556|Secondary|Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale|The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Disability was assessed on a VAS of 0-100, with 0 being absolutely no disability and 100 being maximum disability.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821210|NCT00374556|Secondary|Pressure Pain Threshold|"A Somedic algometer was used to assess pressure pain threshold (PPTh) similar to previous studies. The algometer's 1cm2 rubber probe was placed over the muscle belly, with the pressure increased steadily at a constant rate (30kPA/Sec), until the subject indicated that s/he first felt pain. PPTh was assessed 2 times each, bilaterally, at (in a randomized order) the masseter muscle trapezius muscle, and at the proximal third of the brachioradialis muscle (forearm). The scores from each location were averaged for each participant at that respective time point. The same site was never stimulated consecutively. At least 90 s were maintained between successive stimuli"|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||kPA||Standard Deviation|Mean
2821233|NCT00374335|Secondary|Risk Factors Associated With the Development of Hepatic Hemangiomas|Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound|2 years||||participants|||Number
2821211|NCT00374556|Secondary|Heat Pain Tolerance (HPTOL)|"Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitization. HPTOL was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of HPTOL were conducted. An average of both trials at each respective time point is presented below. Subjects push a button when the stimulus becomes intolerable. The temperature (degrees Celsius) at the time button is pushed to terminate the stimulation is automatically recorded."|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||degrees Celsius||Standard Deviation|Mean
2821212|NCT00374556|Secondary|Heat Pain Threshold|"Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitizationHPTh was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of heat pain threshold were conducted. Averages of both trials are presented from respective time point below. Subjects push a button when the stimulus first feels painful The temperature (degrees Celsius) at the time button is pushed is automatically recorded."|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||degrees Celsius||Standard Deviation|Mean
2821213|NCT00374556|Primary|Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale|The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Pain was assessed on a scale of 0-100, with 0 being absolutely no pain and 100 being maximum pain.|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821214|NCT00374556|Primary|Mean Level of Pain Experienced Throughout the Day|Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821215|NCT00374556|Primary|Temporal Summation (TS)|TS :maximum windup pain rating - first windup pain rating (0-100). Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to left forearm. In order to assess temporal summation, three sequences of 10 heat pulses each (with stimulus temperatures of 46 degrees C, 48 degrees C, and 50 degrees C, in random order) were applied to left dorsal forearm. The thermode remains in fixed position during administration of 10 heat pulses that constitute a sequence. Within each sequence, successive thermal pulses at a given temperature are delivered for a duration of approximately 0.5 sec each, with a 2.5-sec inter-pulse interval. The rate of rise & fall of the thermode temp. is set at the device max .of 10 degrees C / S. Subjects verbally rate the perceived intensity of each thermal pulse on a 0-100 rating scale & may terminate the procedure at any time.100=max tolerable intensity|Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821216|NCT00374556|Primary|Diffuse Noxious Inhibitory Control (DNIC) Index Scores|"PPTh:a somedic algometer's 1cm2 rubber probe was placed over muscle belly, with pressure increasing steadily at constant rate (30kPA/Sec), until subject indicated that s/he first felt pain. PPTh ratings were obtained on right brachioradialis & right trapezius in a random order (average was taken from both areas at each time point). During each cold pressor task, participants immersed contralateral hand (left) up to wrist, in a circulating cold water bath maintained at 4°C. 20 seconds after commencing hand immersion, PPTh was re-assessed on either right brachioradialis or right trapezius (the same site as baseline assessment). After PPTh assessment, participants removed hands from water. DNIC was measured as the % change in PPTh during cold pressor, relative to baseline PPTh [i.e., (mean PPTh during cold pressor / mean PPTh prior to cold pressor)*100]. Increase in PPTh during cold pressor (i.e., percentage scores above 100) reflects normal functioning of pain-inhibitory processes."|Mean of baseline, 6 week follow-up and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||percentage change of PPTh||Standard Deviation|Mean
2821217|NCT00374556|Primary|Insomnia Severity Index (ISI) Mean Total Scores|The ISI is made up of 7 questions, each possible of earning a score of 0-4, making the total range 0-28, where 0 indicates no severity/no problem with sleep and therefore no insomnia, or 28, being very severe with the highest level of insomnia|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task.|||units on a scale||Standard Deviation|Mean
2821218|NCT00374556|Primary|Sleep Latency as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep latency is the time taken to fall asleep, or equal to lights out- sleep onset (sleep onset: time when sleep is first scored after lights out, first scorable epoch).|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821234|NCT00374335|Primary|Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years||||participants|||Number
2821219|NCT00374556|Primary|Sleep Efficiency as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep efficiency is the index of sleep percentage recorded, equal to total sleep time divided by the time in bed X 100 = X%.|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||percentage of time asleep||Standard Deviation|Mean
2821220|NCT00374556|Primary|TST as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. TST recorded by device = total minutes spent asleep|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821221|NCT00374556|Primary|WASO as Assessed by Actigraphy|Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. WASO recorded by device = total minutes of wakefulness after sleep onset, in minutes.|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821222|NCT00374556|Primary|Sleep Quality (SQ)|As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing)|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||units on a scale||Standard Deviation|Mean
2821223|NCT00374556|Primary|Sleep Efficiency (SE)|[(TST/ TIB)X 100], (%) as recorded in daily sleep diary|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||percentage of efficient sleep||Standard Deviation|Mean
2821224|NCT00374556|Primary|Total Sleep Time (TST)|minutes spent asleep as recorded in daily sleep diary|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821225|NCT00374556|Primary|Number of Awakenings|As recorded in daily sleep diary|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||number of awakenings||Standard Deviation|Mean
2821226|NCT00374556|Primary|Sleep Latency (SL)|Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821227|NCT00374556|Primary|Time in Bed|Total time in bed, in minutes|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821228|NCT00374556|Primary|Wake After Sleep Onset (WASO)|Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes|Mean of baseline, 6 week follow-up, and 12 week follow-up|Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.|||minutes||Standard Deviation|Mean
2821229|NCT00374543|Primary|Hamilton Anxiety Rating Scale (HAM-A)|"The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.~Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks|Zero participants were analyzed because recruitment was very low. Due to this, we felt any analysis done would not be usable for accurate analyses.||||||
2821230|NCT00374543|Secondary|Clinical Global Impression of Improvement (CGI-I)|"A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement.~Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks|||||||
2821231|NCT00374452|Primary|Mean Percentages of Events After Index Visit to Primary Care by Patient|The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.|up to one year after index visit||||mean percentage of events|clinic sites||Number
2821232|NCT00374335|Primary|Presence of Hepatic Hemangiomas on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years|||||||
2821235|NCT00374322|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.|Screening and Month 12/Early Withdrawal Visit|SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.|||Participants|||Number
2821236|NCT00374322|Secondary|Number of Participants Experiencing Primary or Secondary Cardiac Events|A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.|From the date of randomization up to 12 months|Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.|||Participants|||Number
2821237|NCT00374322|Secondary|Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades|"Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as Not Applicable."|From the first dose of study treatment up to 12 months|Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.|||Participants|||Number
2821238|NCT00374322|Secondary|Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters|"The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm."|At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit|Safety Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2821239|NCT00374322|Secondary|Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters|"The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported."|At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit|Safety Population (SP): all randomized participants (par.) who received >=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.|||Participants|||Number
2821240|NCT00374322|Secondary|Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2821256|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis|||words||Standard Deviation|Mean
2821241|NCT00374322|Secondary|Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2821242|NCT00374322|Secondary|Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2821243|NCT00374322|Secondary|Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.|||Participants|||Number
2821244|NCT00374322|Secondary|Modified Disease-free Survival (MDFS)|Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)|||||||
2821245|NCT00374322|Secondary|Number of Participants With CNS Recurrence|The number of participants experiencing a CNS recurrence was summarized.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.|||Participants|||Number
2821246|NCT00374322|Secondary|Time to Central Nervous System (CNS) Recurrence|Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])|||||||
2821247|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)|Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.|From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.|||Percentage of participants|||Number
2821260|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Baseline|Intent to Treat Analysis|||units on a scale||Standard Deviation|Mean
2821248|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)|Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).|From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.|||Percentage of participants|||Number
2821249|NCT00374322|Secondary|Number of Participants Who Died (Overall Survival)|Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.|From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.|||Participants|||Number
2821250|NCT00374322|Primary|Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported.|||Participants|||Number
2821251|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220-221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203-214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
2821252|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220-221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203-214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Baseline|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
2821253|NCT00374244|Secondary|Trail Making Test: Trail A|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220-221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203-214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
2821254|NCT00374244|Secondary|Trail Making Test: Trail A|Working memory by Digit Span and Letter Number Sequencing, and attention/executive functions were measured by the Trail Making Test (Parts A and B). This is an assessment of attention/executive function, it does not have an interpret-able range of scores like a traditional scale. Subjects makes trails on paper against time.|Baseline|Intent to Treat Analysis|||seconds||Standard Deviation|Mean
2821255|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis|||words||Standard Deviation|Mean
2821261|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Endpoint (12 weeks)|Intention to Treat|||ms||Standard Deviation|Mean
2821265|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|Endpoint (12 weeks)|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821266|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|baseline|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821267|NCT00374244|Secondary|CGI Improvement Scale (CGI‐I)|"CGI Improvement Scale (CGI‐I) higher rating correlates with worsening of condition (vs. improvement with lower rating). The CGI-I is scored from 1 to 7 where 1 = 'very much improved' and 7 = 'very much worse'. Clinicians are asked to rate total improvement in the following manner: ...in your judgement, it is due entirely to drug treatment. Compared to his condition at admission to the project, how much has he changed?"|Endpoint (12 weeks)|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821268|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|Endpoint (12 weeks)|Analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821269|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|baseline|Analyzes intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821270|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Endpoint (12 weeks)|Subjects were analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821271|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Baseline|Subjects were analyzed intent to treat.|||units on a scale||Standard Error|Least Squares Mean
2821272|NCT00374231|Other Pre-specified|Time Post Transplant Corticosteroid Withdrawal|The mean days from post transplant corticosteroid withdrawal.|12 months||||days||Standard Deviation|Mean
2821273|NCT00374231|Secondary|Patient Survival.||12 months||||participants|||Number
2821274|NCT00374231|Primary|Incidence of Biopsy Confirmed Acute Rejection at 12 Months.||12 months||||participants|||Number
2821275|NCT00374140|Secondary|Objective Response Rate|Number of patients for which response to treatment was observed / total number of patients.|From beginning of treatment up to 60 months|Evaluable for response included patient had completed at least one cycle of therapy with everolimus.|||percentage of participants||95% Confidence Interval|Number
2821276|NCT00374140|Secondary|Progression-free Survival||From entry into trial to up to 60 months||||months||95% Confidence Interval|Median
2821277|NCT00374140|Secondary|Overall Survival||From entry in trial to up to 60 months||||months||95% Confidence Interval|Median
2821278|NCT00374140|Primary|Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.||Two cycles of treatment with RAD001 (~6 weeks)||||percentage of participants||95% Confidence Interval|Number
2821279|NCT00374127|Secondary|Heart Rate|Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.|180 minutes|Twenty-four participants were included in this analysis.|||BPM||Standard Deviation|Mean
2821280|NCT00374127|Secondary|Carbon Monoxide|Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.|180 minutes|Twenty-four participants were included in this analysis.|||ppm||Standard Deviation|Mean
2821281|NCT00374127|Secondary|Subjective Effects on VAS|Subjective VAS ratings of 'Good Drug Effect' and 'High' averaged across all post-smoking time points when marijuana was smoked as joints and blunts analyzed for all participants. Here, participants indicated how they were feeling on a 100-mm line anchored with 'not at all' at the left end and 'extremely' at the right end, when prompted by a statement|180 minutes|Twenty-four participants were included in this analysis.|||Ratings (mm)||Standard Deviation|Mean
2821282|NCT00374127|Secondary|Subjective Effects on MRF|"Using the Marijuana Rating Form (MRF), subjective effects of Take Again, Liking, and Strong were assessed. The MRF is a visual analog scale allowing patients to indicate how they feel on a 100-mm line anchored with 'not at all' at the left end and 'extremely' at the right end, when prompted by a statement."|180 minutes|Twenty four participants were included in this within-subjects analysis.|||Ratings (mm)||Standard Deviation|Mean
2821286|NCT00374088|Primary|Maximum Decline in Measured Cardiac Output|Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups.|24 hours|Patients in which the surgeon was technically able to place a 4 French thermodilution catheter into the pulmonary artery at the time of surgery had cardiac output measured.|||L/min/m2||Standard Deviation|Mean
2821287|NCT00373958|Secondary|Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose|Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series and the toddler dose|Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
2821288|NCT00373958|Secondary|Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series and one month after toddler dose|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2821289|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.|||Percentage of participants|||Number
2821290|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Systemic Events|Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.|||Percentage of participants|||Number
2821291|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2821292|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|"Normalization was performed for unit of measure index value as Index Value of 1.00 = 10 mIU/mL."|one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.|||index value||95% Confidence Interval|Geometric Mean
2821293|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.|||µg/mL||95% Confidence Interval|Geometric Mean
2821294|NCT00373958|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)||One month after toddler dose (13 to 16 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.|||percentage of participants||95% Confidence Interval|Number
2821295|NCT00373958|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).|One Month After the Infant Series (7 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.|||Percentage of participants||95% Confidence Interval|Number
2821311|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall|Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
2821296|NCT00373958|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month After the Toddler Dose|Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2821297|NCT00373958|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2821298|NCT00373880|Secondary|Plasma Cocaine|Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.|8 minutes|Eight participants were included in this within-subjects analysis.|||ng/mL||Standard Deviation|Mean
2821299|NCT00373880|Secondary|Subjective Effects of Cocaine|"Mean Visual Analog Scale (VAS) ratings (items: Quality, Pay for Dose, Good Drug Effect, and Cocaine Craving) from 0-100mm as a function of cocaine dose and aripiprazole dose 4 min following a single administration of cocaine (the sample dose) at the start of the session.~For Quality item, the perceived quality of the drug is rated. The higher the rating, the better quality the drug was perceived to be.~For Pay for Dose item, the likelihood that the participant would pay for the drug is indicated. Higher ratings indicate a better likelihood that the person would pay for the dose received.~For Good Drug Effect, the likelihood of feeling a good drug effect is indicated. The higher the number, the more of a good drug effect the person reported.~For Cocaine Craving, the intensity of craving is reported. Higher scores indicate more craving for cocaine."|5 days|Eight participants were included in this within-subjects analysis.|||Scores on a scale of 0-100mm||Standard Error|Mean
2821300|NCT00373880|Primary|Cocaine Self-administration|"Mean number of cocaine choices as a function of cocaine dose and aripiprazole dose (n=8).~Participants sampled the dose of cocaine available for the session and then had five choices to respond for money ($5.00) or cocaine using a modified progressive-ratio schedule."|5 days|Eight participants were included in this within-subjects analysis.|||Number of Choices||Standard Error|Mean
2821301|NCT00373698|Secondary|SF-36 Physical Component||3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
2821302|NCT00373698|Secondary|SF-36 Mental Component||3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
2821303|NCT00373698|Secondary|Depression|Measure using the Hopkins Symptom Checklist-20|3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
2821304|NCT00373698|Primary|PTSD Symptom Severity|PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)|3 and 6 months after initial assessment||||units on a scale||Standard Deviation|Mean
2821305|NCT00373685|Other Pre-specified|Percentage of Participants With Non-study Medication Utilization|Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.|Baseline through week 24 or ET|ITT; N= number of evaluable participants analyzed|||Percentage of participants|||Number
2821306|NCT00373685|Other Pre-specified|Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization|PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.|Baseline through week 24 or ET|ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed|||Percentage of participants|||Number
2821307|NCT00373685|Other Pre-specified|Percentage of Participants With Positive Blood Fecal Occult|Positive blood fecal occult; blood in feces that is not visibly apparent|Week 24 or ET|ITT|||Percentage of participants|||Number
2821308|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
2821309|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
2821310|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF|||Percentage of participants|||Number
2821312|NCT00373685|Secondary|Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline|Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF|||Percentage of participants|||Number
2821317|NCT00373685|Secondary|Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)|GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions|Baseline through week 24 or ET|ITT|||Percentage of participants|||Number
2821318|NCT00373685|Secondary|Percentage of Participants With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to Gastrointestinal Signs and Symptoms; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function."|Baseline through week 24 or ET|ITT;|||Percentage of participants|||Number
2821319|NCT00373685|Primary|Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.|Baseline through week 24 or Early Termination (ET)|Intent-to-Treat (ITT) Population: randomized participants|||Percentage of participants|||Number
2821320|NCT00373529|Other Pre-specified|Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors|The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.|approximately Month 2|Full analysis set (FAS) of participants who achieved remission and had baseline prognostic factor|||participants|||Number
2821321|NCT00373529|Secondary|Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)|Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.|up to Day 30|Full analysis set|||percentage of participants|||Number
2821322|NCT00373529|Secondary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods|"Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline.~NCI Common Terminology Criteria for Severity:~Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE"|Up to 2 years|Full analysis set|||participants|||Number
2821323|NCT00373529|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.|Up to 2 years|Full analysis set|||weeks||95% Confidence Interval|Median
2821324|NCT00373529|Secondary|Kaplan Meier Estimate for Disease-free Survival (DFS)|DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.|||weeks||95% Confidence Interval|Median
2821325|NCT00373529|Secondary|Kaplan Meier Estimate for Duration of Remission (DOR)|DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day. Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.|||weeks||95% Confidence Interval|Median
2821326|NCT00373529|Primary|Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)|Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.|approximately Month 2|Full analysis set (FAS)|||percentage of participants|||Number
2821327|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 21 (400 mg)||Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.|||μM||Standard Deviation|Geometric Mean
2821328|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 3 (600 mg)||Day 3 (600 mg)||||μM||Standard Deviation|Geometric Mean
2821329|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)||Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.|||μM||Standard Deviation|Geometric Mean
2821330|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)|Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.|||μM·hr||Standard Deviation|Geometric Mean
2821331|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)|Day 3 (600 mg)||||μM·hr||Standard Deviation|Geometric Mean
2821377|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief|Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.|||participants|||Number
2821332|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.|Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.|||μM·hr||Standard Deviation|Geometric Mean
2821333|NCT00373490|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment|21 Days (first cycle)|Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment.|||Participants|||Number
2821334|NCT00373425|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.~A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.|Randomized Cohort, safety analysis set: all randomized participants who received at least one dose of study drug. One participant in the Randomized Cohort assigned to the erlotinib arm received placebo instead due to a dispensing error and is included in the placebo group for safety analyses.|||participants|||Number
2821335|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)|Randomized cohort full analysis participants who were EGFR mutation positive|||months||95% Confidence Interval|Median
2821336|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)|Randomized cohort full analysis participants who were EGFR mutation positive|||months||95% Confidence Interval|Median
2821337|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set (all randomized participants).|||months||95% Confidence Interval|Median
2821338|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set participants who are EGFR mutation positive|||months||95% Confidence Interval|Median
2821339|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set participants who are EGFR mutation positive|||months||95% Confidence Interval|Median
2821340|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set|||months||95% Confidence Interval|Median
2821962|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821341|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set|||months||95% Confidence Interval|Median
2821342|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set (all randomized participants).|||months||95% Confidence Interval|Median
2821343|NCT00373399|Primary|Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making]|"A modified version of the Gambling Task (Bechara et al., 1994) was used. Four decks of cards (A-D) were displayed on a computer screen. Volunteers were told that the objective of the game was to win as much money as possible. They were also told that the game entailed a series of card selections from any of the decks, one card at a time, and that they should select cards until instructed to stop. The task was stopped after 100 card selections or after 5 min had elapsed. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Higher numbers indicate better decision making regarding advantageous cards.~Planned comparisons using single degrees of freedom, generated by a two-tailed repeated measures analysis of variance (ANOVA), were used to examine the effects of THC concentration (0% vs. 1.8%, 0% vs. 3.9%, and 1.8% vs. 3.9%) on task performance."|3 weeks|All participants who completed the study (N=36) were included in the final analysis.|||mean number of cards||Standard Deviation|Mean
2821344|NCT00373386|Secondary|HDL|Plasma HDL|3 months||||mg/dl||Standard Error|Mean
2821345|NCT00373386|Secondary|LDL|LDL level|3 months||||mg/dl||Standard Error|Mean
2821346|NCT00373386|Secondary|Triglycerides|Plasma Triglycerides|3 months||||mg/dl||Standard Error|Mean
2821347|NCT00373386|Secondary|HOMA|Insulin resistance|3 months||||mg uU/dl ml||Standard Error|Mean
2821348|NCT00373386|Secondary|Insulin|Plasma insulin|3 months||||uU/ml||Standard Error|Mean
2821349|NCT00373386|Secondary|Glucose|Plasma glucose|3 months||||mg/dl||Standard Deviation|Mean
2821350|NCT00373386|Primary|Reactive Hyperemic Response After 3 Months of Growth Hormone|Forearm blood flow (FBF) was measured using strain gauge venous occlusion plethysmography using a Hokanson EC6 plethysmograph (DE Hokanson Inc, Bellevue, WA) in the left arm. With this technique sphygmomanometric cuffs were placed on the arm at the wrist and on the upper arm. During measurement the wrist cuff was inflated to 200 mmHg to occlude flow to the hand which is primarily skin blood flow and the upper arm cuff is inflated to 40 mmHG for 10 out of every 15 second to occlude venous return. FBF was obtained by measuring arm expansion with an indium-in-silastic strain gauge. Data was recorded using PowerLab and Chart 4.0 (AD Instruments, Grand Junction, CO) on a Power Mac G4 computer (Apple, Cupertino, CA).For each subject two minutes of baseline FBF were recorded and then the upper arm cuff was inflated to 200 mmHg pressure for five minutes to occlude flow to the arm. It was then released and forearm blood flow was measured for the next minute.|3 months||||ml/dl min||Standard Error|Mean
2821351|NCT00373360|Secondary|Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||number of times per day||Standard Deviation|Mean
2821352|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||number of times per day||Standard Deviation|Mean
2821353|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||number of times per day||Standard Deviation|Mean
2821354|NCT00373360|Secondary|Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
2821355|NCT00373360|Secondary|Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
2821356|NCT00373360|Secondary|Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
2821357|NCT00373360|Secondary|Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8||||minutes||Standard Deviation|Mean
2821358|NCT00373360|Secondary|Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.|Baseline and Week 8||||participants|||Number
2821359|NCT00373360|Secondary|Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.|Baseline and Week 8||||participants|||Number
2821360|NCT00373360|Secondary|Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8|Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.|Baseline and Week 8||||participants|||Number
2825131|NCT00343564|Secondary|Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||hr||Standard Deviation|Mean
2821362|NCT00373360|Secondary|Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2821363|NCT00373360|Secondary|Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2821364|NCT00373360|Secondary|Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2821365|NCT00373360|Secondary|Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2821366|NCT00373360|Secondary|Change in Symptoms of Chest Pain From Baseline to Week 8|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
2821367|NCT00373360|Secondary|Change in Symptoms of Syncope From Baseline to Week 8|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
2821368|NCT00373360|Secondary|Change in Symptoms of Fatigue From Baseline to Week 8|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
2821369|NCT00373360|Secondary|Change in Symptoms of Dizziness From Baseline to Week 8|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
2821370|NCT00373360|Secondary|Change in Symptoms of Orthopnea From Baseline to Week 8|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
2821371|NCT00373360|Secondary|Change in Symptoms of Edema From Baseline to Week 8|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline to Week 8||||percentage of participants|||Number
2821372|NCT00373360|Secondary|Change in Symptoms of Dyspnea From Baseline to Week 8|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8||||percentage of participants|||Number
2821373|NCT00373360|Secondary|Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 8||||percentage of participants|||Number
2821374|NCT00373360|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2821375|NCT00373360|Primary|Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.||Baseline and Week 8|"As this was a small open label study, the statistics applied to the results were descriptive. For all efficacy endpoints, data obtained from study assessments during the treatment phase were compared to Baseline.~assessments"|||meters||Standard Deviation|Mean
2821376|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity|Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.|||participants|||Number
2821378|NCT00373334|Primary|Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success|The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.|8 weeks|The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.|||participants|||Number
2821379|NCT00373295|Primary|Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke.~Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)||||dollars spent on marijuana||Standard Deviation|Mean
2821380|NCT00373269|Secondary|TF-PCA|TF-PCA levels compared between normoglycemic and hyperglycemic subjects.|Baseline||||U/ml||Standard Deviation|Mean
2821381|NCT00373269|Primary|FVIIa|FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.|Baseline||||mU/ml||Standard Deviation|Mean
2821382|NCT00373256|Secondary|Biomarkers|Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.|Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1|ITT. Biomarker data were collected, but since the study was stopped early and there were too few events of OS, PFS, etc, data were not analyzed.||||||
2821383|NCT00373256|Secondary|EQ - Visual Analog Scale (EQ-VAS)|"EQ-VAS score on the self-rated thermometer, indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state."|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-VAS evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.||||||
2821384|NCT00373256|Secondary|Euro Quality of Life-5 Dimension (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-5D evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.||||||
2821385|NCT00373256|Secondary|EORTC QLQ Breast Cancer Module (BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. BR23 evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.||||||
2821386|NCT00373256|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EORTC QLQ-C30 evaluations were not analyzed since enrollment in this study was terminated early for futility.||||||
2821387|NCT00373256|Secondary|Percentage of Participants Surviving at 1 and 2 Years|Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.|Year 1, Year 2|ITT.|||percentage of participants|||Number
2821388|NCT00373256|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.|From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.|ITT. The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.|||Months||95% Confidence Interval|Median
2821389|NCT00373256|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 78 subjects reported CR or PR response and were analyzed for DR in each treatment group.|||Months||95% Confidence Interval|Median
2821390|NCT00373256|Secondary|Number of Participants With Objective Response|Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months|ITT|||participants|||Number
2821391|NCT00373256|Primary|Progression-Free Survival (PFS)|Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death|The intent-to-treat (ITT) population included all patients who were randomized.|||Months||95% Confidence Interval|Median
2821392|NCT00373113|Secondary|EORTC QLQ Breast Cancer Module (BR23)|"BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.~Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ Cancer Module (BR23) analysis was not performed.|||scores on a scale||Standard Deviation|Mean
2821393|NCT00373113|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|"EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).~Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ-C30 analysis was not performed.|||scores on a scale||Standard Deviation|Mean
2821394|NCT00373113|Secondary|Overall Survival (OS)|Average time from randomization to first documentation of death due to any cause.|From time of randomization until death|ITT population|||Months||95% Confidence Interval|Median
2821395|NCT00373113|Secondary|Time to Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|The study was stopped early for futility and TTR analysis was not performed.|||Months||95% Confidence Interval|Median
2821396|NCT00373113|Secondary|Duration of Response (DR)|Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months or death|ITT population. DR was calculated for the subgroup of participants with objective response. 27 participants in the sunitinib arm and 40 participants in the capecitabine arm reported CR or PR response and were analyzed for DR.|||Months||95% Confidence Interval|Median
2821397|NCT00373113|Secondary|Number of Participants With Overall Response (OR)|OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population|||Participants|||Number
2821398|NCT00373113|Secondary|Time to Tumor Progression (TTP)|Time from randomization to first documentation of objective tumor progression.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population|||Months||95% Confidence Interval|Median
2821399|NCT00373113|Primary|Progression-Free Survival (PFS)|Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.|From time of randomization to every 6 weeks thereafter through 22 months or until death|Intent-to-treat (ITT) population: included all participants who were randomized.|||Months||95% Confidence Interval|Median
2821400|NCT00372996|Secondary|EORTC QLQ Breast Cancer Module (BR23) Scores|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 â€˜Not at Allâ€™ to 4 â€˜Very Muchâ€™). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821401|NCT00372996|Secondary|European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821402|NCT00372996|Secondary|Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway||Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821403|NCT00372996|Secondary|Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)||Predose on Day 1 of Cycle 1|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821404|NCT00372996|Secondary|Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)|Negative human anti-human antibodies were defined as <6.64|Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion|All randomized participants who started treatment and who had at least 1 sample submitted for the biomarker; collection of samples for this analysis was stopped after Amendment 6. All samples were negative to HAHA.|||participants|Participants||Number
2821405|NCT00372996|Secondary|Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821406|NCT00372996|Secondary|Minimum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821407|NCT00372996|Secondary|Maximum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and pharmacokinetic (PK) sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.||||||
2821408|NCT00372996|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months|Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS|||percentage of participants||95% Confidence Interval|Number
2821409|NCT00372996|Primary|PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS; only participants with baseline HbA1c <5.7% were included in the analysis.|||months||95% Confidence Interval|Median
2821410|NCT00372996|Primary|Progression-Free Survival (PFS)|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|Full Analysis Set (FAS): all enrolled participants; grouped by randomized arm, where the first 10 participants enrolled but not randomly assigned to treatment were not included.|||months||95% Confidence Interval|Median
2821411|NCT00372970|Primary|Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.|"Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI).~The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be >=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores."|1 month|All patients had gastroparesis and underwent EGD. Injection double blinded.|||units on a scale||Standard Deviation|Mean
2821437|NCT00372775|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2821412|NCT00372957|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is serious corresponding to those listed in above definition.|Up to post-study screen (Follow-up [7 days after the last dose of study medication])|Safety Population comprised of all participants who received study medication (active or placebo).|||Participants|||Count of Participants
2821413|NCT00372957|Primary|Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma glucose concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing sodium fluoride, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2821414|NCT00372957|Primary|C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma C-peptide concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||ng/mL||Standard Deviation|Mean
2821415|NCT00372957|Primary|Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma glucagons concentrations, approximately 2 mL of whole blood was collected into a vacuum tube containing aprotinin, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Picogram per milliliter (pg/mL)||Standard Deviation|Mean
2821416|NCT00372957|Primary|Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of plasma insulin, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2Na, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Micro units per milliliter (µU/mL)||Standard Deviation|Mean
2821417|NCT00372957|Primary|Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7|For the analysis of active GLP-1 concentrations, approximately 3 mL of whole blood was collected into a vacuum tube containing DPP-IV inhibitor, and then centrifuged in a refrigerated centrifuge at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented the active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis for weighted mean AUCs has been presented in the statistical analysis section.|Baseline (Day -1) and Day 7|PD Parameter Population.|||Picomole (pM)||Standard Deviation|Mean
2821438|NCT00372775|Secondary|Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score|Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data|||Scores on a scale||95% Confidence Interval|Mean
2821541|NCT00372229|Secondary|Proteomics Parameter: Nephropathy|Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.|||score on a scale||Standard Deviation|Mean
2821418|NCT00372957|Primary|DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7|For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing EDTA2K and centrifuged at approximately 4 degree Celsius, at approximately 2500 rpm for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. Double-delta represented active treatment within participant change from Baseline summarized across participants, subtracted from placebo within participant change from Baseline summarized across participants. AUC with respect to these time interval was calculated using linear trapezoidal rule by sum of the areas between each chronological pair of assessments (using observed times). Weighted mean was then determined by dividing AUC by observed length of collection interval (time of last assessment - time of first assessment in hr). Double-delta analysis has been presented in analysis. Unit of measure: Nano mole per minute per milliliter (nmol/min/mL).|Baseline (Day -1) and Day 7|Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available.|||nmol/min/mL||Standard Deviation|Mean
2821419|NCT00372957|Primary|Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)|For analysis of DPP-IV activity, approximately 2 mL of whole blood was collected into a vacuum tube containing ethylenediamine tetraacetic acid (EDTA2K) and centrifuged at approximately 4 degree Celsius, at approximately 2500 revolution per minute (rpm) for 15 minutes. Samples were stored in a freezer at -70 degree Celsius or lower. DPP-IV inhibition was estimated by using the percent change from pre-dose of DPP-IV activity. DPP-IV inhibition was done at pre-dose, 0.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr.|Day 7|Pharmacodynamic (PD) Parameter Population comprised of all participants who received study medication (active or placebo) and for whom PD data was available.|||Percent inhibition|||Number
2821420|NCT00372957|Primary|Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs)|PK parameters were calculated using data at the actual time of blood collection. R[Cmax], Ro and Rs were determined from plasma concentration-time data, using standard model independent methods. R[Cmax] = Cmax (Day 7)/Cmax (Day 1), Ro = AUC(0-tau) (Day 7)/ AUC(0-tau) (Day 1) and Rs = AUC(0-tau) (Day 7)/ AUC(0-inf) (Day 1).|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Ratio||95% Confidence Interval|Geometric Mean
2821421|NCT00372957|Primary|Standard PK Parameter: Apparent Volume of Distribution (Vz/F)|PK parameters were calculated using data at the actual time of blood collection. Vz/F was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||L||95% Confidence Interval|Geometric Mean
2821422|NCT00372957|Primary|Standard PK Parameter: Total Clearance (CL/F)|PK parameters were calculated using data at the actual time of blood collection. CL/F was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
2821423|NCT00372957|Primary|Standard PK Parameter: Constant Rate of Elimination (lambda_z)|PK parameters were calculated using data at the actual time of blood collection. Lambda_z was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||1/hr||95% Confidence Interval|Geometric Mean
2821424|NCT00372957|Primary|Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)|PK parameters were calculated using data at the actual time of blood collection. %AUCex was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Percentage of AUCex||95% Confidence Interval|Geometric Mean
2821425|NCT00372957|Primary|Standard PK Parameter: Area Under the Plasma Drug Concentration Versus Time Curve Extrapolated to Infinity (AUC[0-inf]), AUC From 0 to the Last Measurable Concentration (AUC[0-t])|PK parameters were calculated using data at the actual time of blood collection. AUC[0-inf] and AUC[0-t] was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Hr.ng/mL||95% Confidence Interval|Geometric Mean
2821426|NCT00372957|Primary|Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2)|PK parameters were calculated using data at the actual time of blood collection. T1/2 was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Hour||95% Confidence Interval|Geometric Mean
2821427|NCT00372957|Primary|Standard PK Parameter: Time at Which Cmax Was Observed (Tmax)|PK parameters were calculated using data at the actual time of blood collection. Tmax was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population.|||Hour||Full Range|Median
2821428|NCT00372957|Primary|Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax)|PK parameters were calculated using data at the actual time of blood collection. Cmax was determined from plasma concentration-time data, using standard model independent methods.|Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)|PK Parameter Population comprised of all participants who received an active dose of GW823093C and for whom PK data was collected.|||Nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2821439|NCT00372775|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score|Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data|||Scores on a scale||95% Confidence Interval|Mean
2821440|NCT00372775|Secondary|Number of Deaths Due to Intracranial Versus Systemic Progression|Number of deaths determined to be intracranial versus systemic progression, according to investigators'assessment.|Baseline until death (up to 1 year)|ITT|||Participants|||Number
2821429|NCT00372905|Post-Hoc|Median Progression Free Survival|"Median progression free survival (PFS) will be assessed by CT scans after induction therapy, consolidation therapy, every 3 months for the first year following treatment and every 6 months for the second year.~Progressive disease is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size or at least a 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis."|At start of treatment, at completion of induction therapy, at completion of consolidation therapy, every 3 months for 1 year, and every 6 months for 1 year|The first 9 patients data that were enrolled in the phase I dose escalation portion were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the PFS of patients with this drug combination (dose was irrelevant)|||Months||Full Range|Median
2821430|NCT00372905|Post-Hoc|Overall Response Rate|"The overall response rate at the completion of treatment was defined as complete response plus partial response.~Complete response (CR)=A post-treatment residual mass of any size is permitted as long as it is PET-negative and normalization of those biochemical abnormalities.~Partial response (PR)=50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in the size of the other nodes, liver or spleen, and no new sites of disease.~Stable disease=Failing to attain the criteria for PR or CR, but not fulfilling those for progressive disease.~Progressive disease(PD)=At least a 50% increase from nadir in the SPD of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size."|At baseline, after induction cycle (1 cycle =28 days) and consolidation therapy of a maximum of 3 cycles (1cycle =28 days), up to approximately 6 months|Data for first 9 patients enrolled in phase I dose escalation portion of the study were collected, analyzed and reported on. Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant)|||percentage of patients|||Number
2821431|NCT00372905|Secondary|Number of Patients With Adverse Events Related to Treatment of Bortezomib Combined With Y-90-ibritumomab Tiuxetan|"To further explore the toxicity bortezomib combined with Y-90-ibritumomab tiuxetan by collecting data on adverse events (AE) reported by patient or collected lab results that are grade 3 or grade 4 that were determined to be at least possible related to any of the studies drugs.~Toxicity will be collected on treatment days according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|At start of treatment on days 1, 8, 15, 22 of induction, days 36 and 50 of recovery, days 1, 8, 15 of consolidation cycles for up to 3 cycles and 4 weeks after the completion of treatment.|Toxicity data for 9 patients enrolled in the dose escalating cohorts 1, 2 and 3 was collected and analyzed only. Data for the 3 cohorts are presented combined as the objective is to report grade 3 and 4 toxicities with this combination of drugs (dose of bortezomib is irrelevant)|||Participants|||Count of Participants
2821432|NCT00372905|Primary|Maximum Tolerated Dose (MTD) and Tolerability of Bortezomib Combined With Y-90-Ibritumomab Tiuxetan Determined by Number of Dose Limiting Toxicities in a Cohort.|"To determine the MTD using a 3+3 dose escalating design. There will be 3 dose cohorts:1.0mg/m2,1.3mg/m2 and1.6 mg/m2. 3 patients will be enrolled at dose of 1.0mg/m2 bortezomib. If no dose limiting toxicities (DLTs) are seen in the first 3 patients then dose will be escalated to next level and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced.~DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0.~DLTs=grade 3 nausea, vomiting, diarrhea or ileus more than 96h; grade 4 nausea, vomiting, diarrhea or ileus,neuropathic pain, peripheral sensory neuropathy, neutropenia, thrombocytopenia."|During induction therapy, the first 28 days of treatment.|Patients enrolled in dose escalation cohorts 1, 2 and 3 analyzed for this outcome measure.|||DLT|||Number
2821433|NCT00372775|Secondary|PFS in Subgroups Defined by RNA Expression Profiles of Tumors|PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.|||weeks||90% Confidence Interval|Median
2821434|NCT00372775|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.|||Percentage of participants|||Number
2821435|NCT00372775|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts|A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.|Day 1 prior to dosing|ITT. c-Kit, Flt-3 and c-Fms with blood count samples collected; however, no statistical analyses performed since power was insufficient.|||picograms per milliliter (pg/mL)|||Number
2821436|NCT00372775|Secondary|Ctrough of Sunitinib Metabolite (SU012662)|A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.|||ng/mL||Standard Deviation|Mean
2821443|NCT00372775|Secondary|Duration of Response (DR)|DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|Day 7 of Week 4 and every 4 weeks up to 1 year|ITT. DR only calculated for the subgroup of participants with an objective tumor response.|||Weeks|||Number
2821444|NCT00372775|Secondary|Number of Participants With Intracranial Objective Disease Response|Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable intracranial disease at baseline.|||Participants|||Number
2821445|NCT00372775|Secondary|Time to Objective Intracranial Progression|Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)|ITT|||Weeks||95% Confidence Interval|Median
2821446|NCT00372775|Secondary|Number of Participants With Objective Disease Response|Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable disease at baseline.|||Participants|||Number
2821447|NCT00372775|Secondary|Time to Neurological Progression (TNP)|Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 28 to focal neurological deficit (up to 1 year)|ITT|||Weeks||Full Range|Median
2821448|NCT00372775|Secondary|Time to Tumor Progression (TTP)|Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)|ITT|||Weeks||95% Confidence Interval|Median
2821449|NCT00372775|Primary|Progression-Free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)|Intent-to-treat (ITT): all participants enrolled in the study who received at least 1 dose of study medication.|||Weeks||90% Confidence Interval|Median
2821450|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)|The AcroQoL contains 14 items on Psychological aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the psychological scale ranges from 14-70. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.|||Percent of maximum score||Standard Deviation|Mean
2821451|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)|The AcroQoL contains 8 items on Physical aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the physical scale can range from 8-40. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.|||Percent of maximum score||Standard Deviation|Mean
2821452|NCT00372697|Secondary|Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)|The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.|Week 12 and end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.|||Percentage of participants|||Number
2821559|NCT00372190|Secondary|Mesh Exposure at 12 Months|cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)|12 months||||participants|||Number
2821453|NCT00372697|Secondary|Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.|||Percentage of participants|||Number
2821454|NCT00372697|Secondary|Change in Tumor Volume From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.|||mm^3||Standard Deviation|Mean
2821455|NCT00372697|Primary|Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)|Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.|||µg/L||Standard Deviation|Mean
2821456|NCT00372697|Primary|Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)|Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.|||µg/L||Standard Deviation|Mean
2821457|NCT00372619|Secondary|Correlate the Expression of Apoptosis Specific Genes|Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).|End of therapy|The analysis was not completed, because the tissue microarray was unsuccessful.||||||
2821458|NCT00372619|Secondary|Safety and Tolerability as Measured by CTCAE v3.0|Number of participants with at least one grade 3 or higher adverse event during therapy.|End of therapy|Ineligible (n=2) and inevaluable (n=1) patients are excluded|||number participants|||Number
2821459|NCT00372619|Primary|Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)|"Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL).~Overall response for AML patients: (CR + CRp), defined as:~CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week))."|2 cycles or up to 84 days||||participants|||Number
2821460|NCT00372593|Secondary|Toxicities, Including Infectious Complications|Number of participants with at least one grade 3 or higher adverse event during therapy.|From the time therapy is initiated, assessed up to 10 years|Ineligible (n=42) patients are excluded.|||Number of participants|||Number
2821461|NCT00372593|Secondary|Time to Marrow Recovery|Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.|At 25 days after treatment with Induction I, Induction II, and Intensification I|Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)|||Mean days||Standard Deviation|Mean
2821462|NCT00372593|Secondary|Mortality|Number of participants who died during the first three courses of therapy.|During the first three courses of therapy|Ineligible (n=42) patients are excluded.|||Number of participants|||Number
2821463|NCT00372593|Secondary|Disease-free Survival (DFS)|Time from end of Intensification I to relapse, death or last contact|At 3 years from end of Intensification I|Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247).|||Percentage participants DFS at 3 years||95% Confidence Interval|Number
2821464|NCT00372593|Secondary|Remission Induction Rate After 2 Courses of Induction Therapy|Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.|After 2 courses of induction (I and II) therapy, assessed for up to 10 years|Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45).|||Proportion of participants|||Number
2821465|NCT00372593|Primary|Overall Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.|||percentage of participants||95% Confidence Interval|Number
2821466|NCT00372593|Primary|Event-free Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry to time of induction failure, relapse, or death, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.|||percentage of participants||95% Confidence Interval|Number
2821467|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a scale||Standard Deviation|Mean
2821468|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm|"EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a scale||Standard Deviation|Mean
2821469|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a Scale||Standard Deviation|Mean
2821470|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.|||Scores on a scale||Standard Deviation|Mean
2821471|NCT00372567|Secondary|Number of Participants With Pain Progression|Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.|||Participants|||Number
2821472|NCT00372567|Secondary|Number of Participants With Pain Relief Response|Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.|||Participants|||Number
2821473|NCT00372567|Secondary|Time to Pain Progression (TTPP)|TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an event.|||Days||95% Confidence Interval|Median
2821474|NCT00372567|Secondary|Duration of Response (DR)|"Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.~Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions."|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.|||Weeks||Full Range|Median
2821475|NCT00372567|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT|||Weeks||95% Confidence Interval|Median
2821522|NCT00372229|Secondary|Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants. Only participants without active CMV infection were included in this analysis; 1 participant in each treatment arm had not developed active CMV infection until Month 72, and thus, they were only included in the number analyzed for results before that timepoint.|||Participants|||Count of Participants
2821476|NCT00372567|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT|||Participants|||Number
2821477|NCT00372567|Secondary|Time to Treatment Failure (TTF)|TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with treatment failure.|||Months||95% Confidence Interval|Median
2821478|NCT00372567|Secondary|Time to Pain Relief Response (TTPR)|Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT|||Days||95% Confidence Interval|Median
2821479|NCT00372567|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.|Baseline up to 2 years|ITT|||Months||95% Confidence Interval|Median
2821480|NCT00372567|Primary|Progression-Free Survival (PFS)|Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.|Baseline, Week 5, and every 8 weeks until Year 2|Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).|||Months||95% Confidence Interval|Median
2821481|NCT00372528|Secondary|Mean Number of Seizures|Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.|Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)|SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.|||Seizures||Standard Deviation|Mean
2821482|NCT00372528|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Year 5 and follow-up (30 days after last dose)|Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.|||Participants|||Number
2821483|NCT00372489|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change|||percentage of participants|||Number
2821484|NCT00372424|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Paclitaxel||End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|Data not analyzed since paclitaxel was not administered in the study.||||||
2821485|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of Trastuzumab|Ctrough = the concentration prior to study medication administration.|Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6|Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.||||||
2821486|NCT00372424|Secondary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel|Concentration values below the lower limit of quantification were taken as zero.|End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.|||ng/mL||Standard Deviation|Mean
2821487|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)|Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.|Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1|Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2821488|NCT00372424|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
2821538|NCT00372229|Secondary|Percentage of Participants With Leukopenia Within 12 Months|Leukopenia: white blood cell (WBC) of < 3,500/microlitre (μL) and < 1,000/μL|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821489|NCT00372424|Secondary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population included all participants who received at least 1 dose of study medication.|||weeks||95% Confidence Interval|Median
2821490|NCT00372424|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.|||percentage of participants||95% Confidence Interval|Number
2821491|NCT00372424|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From screening until 28 days post last dose of study drug|Safety population included all participants enrolled in the study who received at least 1 dose of study medication.|||participants|||Number
2821492|NCT00372411|Secondary|Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline|The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.|12 weeks minus baseline||||units on a scale||Standard Error|Least Squares Mean
2821493|NCT00372411|Secondary|Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline|The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).|12 weeks minus baseline||||units on a scale||Standard Error|Least Squares Mean
2821494|NCT00372411|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline||||Seconds||Standard Error|Least Squares Mean
2821495|NCT00372411|Secondary|Stroke Impact Scale|The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline||||units on a scale||Standard Error|Least Squares Mean
2821496|NCT00372411|Primary|Fugl-Meyer Assessment for Motor Recovery (FM) Scale|Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|All participants with baseline and follow-up measures were included by intention-to-treat|||units on a scale||Standard Error|Least Squares Mean
2821497|NCT00372385|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2821498|NCT00372385|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
2821509|NCT00372255|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years|A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|21 days post-vaccination (Day 21)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Participants|||Count of Participants
2821499|NCT00372385|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||participants|||Number
2821500|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2821501|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2821502|NCT00372385|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2821503|NCT00372255|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group|The analysis was performed on the Total Vaccinated Cohort, included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available.|||Participants|||Count of Participants
2821504|NCT00372255|Secondary|Number of Subjects With Unsolicited Adverse Events.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During 31 days after the study vaccine dose (Day 0-30)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available.|||Participants|||Count of Participants
2821505|NCT00372255|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination.|During the 4-day (Day 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose.|||Participants|||Count of Participants
2821506|NCT00372255|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available and who had a dairy card available. Post Dose 2 results are not available for the 10-13 years Group as these subjects received only one dose.|||Participants|||Count of Participants
2821507|NCT00372255|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|21 days post-vaccination (Day 21)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Participants|||Count of Participants
2821508|NCT00372255|Secondary|Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years|Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre < 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|21 days post-vaccination (Day 21)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Participants|||Count of Participants
2821539|NCT00372229|Secondary|Percentage of Participants With Graft Survival at Month 12||Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821510|NCT00372255|Secondary|SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|21 days post-vaccination (Day 21)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Fold increase||95% Confidence Interval|Geometric Mean
2821511|NCT00372255|Secondary|Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years|Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|21 days post-vaccination (Day 21)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Titres||95% Confidence Interval|Geometric Mean
2821512|NCT00372255|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years|A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Participants|||Count of Participants
2821513|NCT00372255|Primary|Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Fold increase||95% Confidence Interval|Geometric Mean
2821514|NCT00372255|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years|Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.|28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.|||Titer||95% Confidence Interval|Geometric Mean
2821515|NCT00372229|Secondary|Creatinine Clearance at Month 24 and Every 12 Months up to Month 84|Creatinine Clearance estimated by Cockcroft-Gault formula.|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||millimiters/minute||Standard Deviation|Mean
2821516|NCT00372229|Secondary|Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants. The number analyzed in the table indicates the number of participants with at least one rejection episode at each timepoint.|||graft rejections|||Number
2821517|NCT00372229|Secondary|Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821518|NCT00372229|Secondary|Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821519|NCT00372229|Secondary|Number of Participants Who Had Lost Their Transplant or Died up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821520|NCT00372229|Secondary|Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84|An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).|Up to 84 months|The intent-to-treat (ITT) population included all randomized participants. Only participants in the Pre-emptive CMV Therapy arm (separated based on their active CMV infection status at Month 84) were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2821521|NCT00372229|Secondary|Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84|An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).|Up to 84 months|The intent-to-treat (ITT) population included all randomized participants. Only participants in the Valganciclovir CMV Prophylaxis arm (separated based on their active CMV infection status at Month 84) were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2821540|NCT00372229|Secondary|Percentage of Participants Surviving at Month 12||Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821523|NCT00372229|Secondary|Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants. Only participants with active CMV infection were included in this analysis; 1 participant in each treatment arm had not developed active CMV infection until Month 72, and thus, they were only included in the number analyzed for results starting from that timepoint.|||Participants|||Count of Participants
2821524|NCT00372229|Secondary|Number of Participants Who Had Lost Their Transplant up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821525|NCT00372229|Secondary|Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821526|NCT00372229|Secondary|Number of Participants Who Died From Months 24 to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821527|NCT00372229|Secondary|Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84||From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821528|NCT00372229|Secondary|Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84|CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821529|NCT00372229|Secondary|Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84|Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821530|NCT00372229|Secondary|Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84|CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821531|NCT00372229|Secondary|Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84|CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821532|NCT00372229|Secondary|Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84|CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821533|NCT00372229|Secondary|Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84|Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml.|From Month 24 to Month 84|The intent-to-treat (ITT) population included all randomized participants.|||Participants|||Count of Participants
2821534|NCT00372229|Secondary|Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment|Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.|||percentage of participants|||Number
2821535|NCT00372229|Secondary|Percentage of Participants With Post-Transplant Diabetes Mellitus||Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821536|NCT00372229|Secondary|Percentage of Participants With Any Opportunistic Infection Within 12 Months||Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821537|NCT00372229|Secondary|Percentage of Participants With Neutropenia Within 12 Months|Neutropenia: absolute neutrophil count (ANC) < 750/μL within 12 months.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821560|NCT00372190|Primary|"Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months"|"Number of participants with anatomic failures defined as Pelvic Organ Prolapse (POP) stage II or higher"|12 months||||participants|||Number
2821542|NCT00372229|Secondary|Proteomics Parameter: CMV|Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CMV was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.|||score on a scale||Standard Deviation|Mean
2821543|NCT00372229|Secondary|Proteomics Parameter: CKD273|Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273 was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.|||score on a scale||Standard Deviation|Mean
2821544|NCT00372229|Secondary|Relationship Between Proteomics Pattern and Participant Survival|Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.|||score on a scale||Standard Deviation|Mean
2821545|NCT00372229|Secondary|Relationship Between Proteomics Pattern and Graft Survival|Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.|||score on a scale||Standard Deviation|Mean
2821546|NCT00372229|Secondary|Days of Hospitalization||Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||days||Full Range|Median
2821547|NCT00372229|Secondary|Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months||Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2821548|NCT00372229|Secondary|Creatinine Clearance at Month 12|Creatinine clearance was estimated using the Cockcroft-Gault formula.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||millilitre(s)/minute||Standard Deviation|Mean
2821549|NCT00372229|Secondary|Viral Burden at Viremia|Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||copies/ml*days||Standard Deviation|Mean
2821550|NCT00372229|Secondary|Time to Occurrence of First Viremia Within 12 Months|Viremia was defined as plasma PCR ≥ 400 copies/ml.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||days||95% Confidence Interval|Median
2821551|NCT00372229|Secondary|Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months|CMV tissue invasive disease was defined as viremia: PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2821552|NCT00372229|Secondary|Percentage of Participants With CMV Syndrome Within 12 Months|CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2821553|NCT00372229|Primary|Percentage of Participants With Graft Loss at Month 84||Up to 84 months|The intent-to-treat (ITT) population included all randomized participants. Descriptive analysis only.|||percentage of participants|||Number
2821554|NCT00372229|Primary|Urine Proteomic Pattern at Month 12|Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2821555|NCT00372229|Primary|Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease|CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants||96% Confidence Interval|Number
2821556|NCT00372229|Primary|Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months|Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).|Up to 12 months|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants||96% Confidence Interval|Number
2821557|NCT00372190|Secondary|Bulge Symptoms|"Bulge symptoms defined as Prolapse domain score of the Urogenital Distress Inventory (UDI) at 12 months.~Scores range from 0 (least/no bother) to 100 (maximum bother)"|12 months||||units on a scale||Standard Deviation|Mean
2821558|NCT00372190|Secondary|"Patient Global Impression of Improvement (PGI-I) at 12 Months"|Number of participants with much to very much improvement compared to baseline|at 12 months||||participants|||Number
2821561|NCT00372112|Secondary|Tmax of Salmeterol at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
2821562|NCT00372112|Secondary|Cmax of Salmeterol at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2821563|NCT00372112|Secondary|AUC (0-4) of Salmeterol at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2821564|NCT00372112|Secondary|Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14|GW630200 and GSK932009 are metabolites of GW642444H. CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
2821565|NCT00372112|Secondary|Cmax of GW630200 and GSK932009 at Day 1, 7 and 14|GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2821566|NCT00372112|Secondary|AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14|GW630200 and GSK932009 are metabolites of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2821567|NCT00372112|Secondary|Cmax of CCI2189 at Day 1, 7 and 14|CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2821568|NCT00372112|Secondary|AUC (0-4) of CCI2189 at Day 1, 7 and 14|CCI2189 is a counterion of GW642444H. Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC (0-4) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
2821569|NCT00372112|Secondary|Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The time at which Cmax was observed and tlast was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
2821570|NCT00372112|Secondary|Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|PK Concentration Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2821571|NCT00372112|Secondary|AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14|Blood samples were collected on Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose). The pre-dose sample was collected within 5 min prior to study medication administration. The AUC over 4 h as AUC from zero (pre-dose) to 2 h post-dose (AUC [0-2]), AUC from zero (pre-dose) to 4 h post-dose (AUC [0-4]) and AUC from zero (pre-dose) to time of last quantifiable concentration (AUC [0-t]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose)|Pharmacokinetic (PK) Concentration Population comprised of those participants in the Safety Population for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.|||Picogram (pg)*h/mL||Geometric Coefficient of Variation|Geometric Mean
2821572|NCT00372112|Secondary|Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time|Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
2821573|NCT00372112|Secondary|Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time|Blood samples were collected at pre-dose and 4 h post-dose on Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the assessment on Day 1 pre-dose. The weighted mean change from Baseline was the AAUCMB. Change from Baseline in maximum glucose 0-4 h and minimum potassium 0-4 h was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1 to Day 15) values.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2821574|NCT00372112|Secondary|Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14|Blood samples were collected at pre-dose on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on pre-dose, Day 1. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 7 and Day 14) values.|Baseline (Day 1, pre-dose) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole (mmol)/L)||Standard Deviation|Mean
2821575|NCT00372112|Secondary|Number of Participants With Rescue Free Days|Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The percentage of rescue free days during the Run-in week, Week 1, Week 2 and Follow-up Week were assessed. Data is reported for number of participants with < 20%, >=20 to <40%, >=40 to <60%, >=60 to <80% and >=80% rescue free days.|Up to Follow-up (Day 17)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2821576|NCT00372112|Secondary|Mean Use of Rescue Medication Over Period|Ipratropium bromide was provided as the rescue medication. The use of rescue medication was recorded by the participants on daily record cards each day in the morning and evening from Screening up to Follow-up. The mean of 7 days (puffs per 24 h) were reported for the Run-in Week, Week 1, Week 2 and Follow-up.|Up to Follow-up (Day 17)|Safety Population. Only those participants available at the specified time points were analyzed.|||Puffs per 24 h||Standard Deviation|Mean
2821577|NCT00372112|Secondary|Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time|PEF is a measure of lung function and measures how fast a person can breathe out. It was measured using a peak flow meter by the participants and recorded on daily record cards each day in the morning and evening from Screening up to Follow-up. The morning measurements were performed prior to the participant taking the morning dose of study medication or rescue medication. The evening measurements were performed prior to the participant taking the evening dose of study medication or rescue medication. The highest of the 3 values of morning and evening PEF were recorded on the diary card. The mean of 7 days of each morning and evening measurements were reported for the Run-in Week, Week 1, Week 2 and Follow-up.|Up to Follow-up (Day 17)|Safety Population. Only those participants available at the specified time points were analyzed.|||Liters per minute (L/min)||Standard Deviation|Mean
2821578|NCT00372112|Secondary|Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14|FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 over 22-24 h was obtained at Day 1, Day 7 and Day 14 which was recorded up to Day 2, Day 8 and Day 15. Baseline was defined as the assessment on Day 1 pre-dose. Change from Baseline was calculated by subtracting the Baseline (Day 1, pre-dose) value from the individual post Baseline (Day 1, Day 7 and Day 14) values.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||L||Standard Error|Least Squares Mean
2821610|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821579|NCT00372112|Secondary|Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time|FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose and post-dose at Day 1, 2, 7, 8, 14 and 15. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h and maximum FEV1 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||L||Standard Deviation|Mean
2821580|NCT00372112|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time|FEV1 is defined as the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was assessed pre-dose at Day 1, 2, 7, 8, 14 and 15. FEV1 was assessed post-dose at Day 1, 2, 7, 8 and 14. Lung function test of FEV1 was performed at the approximately same time at each visit in the morning and highest of the 3 measurements were recorded. Baseline was defined as the assessment done on pre-dose Day 1. The change from Baseline pre-dose was calculated by subtracting the Baseline value (pre-dose Day 1) from the individual post Baseline (Day 2, 7, 8, 14 and 15) values. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean FEV1 0-4 h change from Baseline was the AAUCMB obtained at Day 1, 2, 7, 8, 14 and 15. The maximum FEV1 0-4 h change from Baseline was obtained at Day 1, Day 2, Day 7, Day 8, Day 14 and Day 15.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||Litres (L)||Standard Deviation|Mean
2821581|NCT00372112|Secondary|Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14|The parameters of biochemistry with their normal range included: basophils (0-0.2 giga cells [GI]/L), eosinophils (0.05-0.55 GI/L), haematocrit (0.41-0.5 ratio), hemoglobin (138-172 g/L), lymphocytes (0.85-4.1 GI/L), mean corpuscle hemoglobin ([MCH] 27-33 picogram [pg]), mean corpuscle hemoglobin concentration ([MCHC] 320-360 g/L), mean corpuscle volume ([MCV] 80-100 femtoliter [fl]), monocytes (0.2-1.1 GI/L), segmented neutrophils (1.8-8 GI/L), total neutrophils (1.8-8 GI/L), platelet count (130-400 GI/L), red blood cell ([RBC] 4.4-5.8 trillion cells [TI]/L) count and white blood cell ([WBC] 3.8-10.8 GI/L) count. The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.|Baseline (Day 1) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2821582|NCT00372112|Secondary|Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14|The parameters of biochemistry with their normal range included: alanine amino transferase ([ALT] 0-48 international units per liter [IU/L]), albumin (32-50 gram [g]/L), alkaline phosphatase ([ALP] 20-125 IU/L), aspartate amino transferase ([AST] 0-42 IU/L), calcium (2.12-2.56 millimole [mmol]/L, chloride (95-108 mmol/L), creatine kinase ([CK] 0-235 IU/L), creatinine (44-124 micromole [µmol]/L), direct bilirubin (0-6 µmol/L), gamma glutamyl transferase ([GGT] 0-65 IU/L), glucose (3.9-6.9 mmol/L), lactate dehydrogenase ([LDH] 0-250 IU/L), potassium (3.5-5.3 mmol/L), sodium (135-146 mmol/L), total bilirubin (0-22 µmol/L), total protein (60-85 g/L), urea (2.5-9 mmol/L) and uric acid (250-510 µmol/L). The assessments were performed on Day 1, Day 7 and Day 14. Baseline was defined as the assessment done on Day 1. Only those parameters for which at least one value of abnormality (to low or to high) change from Baseline, relative to normal ranges were reported are summarized.|Baseline (Day 1) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2821583|NCT00372112|Secondary|Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time|A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the heart's rhythm. The assessment for the events of supra ventricular ectopics, ventricular ectopics and ventricular runs per 24 h was done on Day 1, Day 7 and Day 14.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Number of events||Standard Deviation|Mean
2821584|NCT00372112|Secondary|Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time|A holter monitor is a machine that continuously records the heart's electrical activity. A 3-lead holter ECG monitoring device was used. The monitor was worn for 24 h during normal activity to record the ECG intervals. The assesmment for hourly maximums QTcF and QTcB was done on Day 1, Day 7 and Day 14. For each h of holter monitoring the maximum QTcF for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)^1/3. For each h of holter monitoring the maximum QTcB for that h was calculated using the maximum QT and mean HR of that given h as Maximum QT divided by (60/Mean HR)^1/2.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
2821585|NCT00372112|Secondary|Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time|A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The pre-dose QTcF and QTcB assessment was done at Day 1, 7 and 14. Weighted mean at 0-4 h for QTcF and QTcB at Day 1, 2, 7, 8, 14 and 15 was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The maximum QTcF and QTcB at 0-4 h was obtained at Day 1, 2, 7, 8, 14 and 15.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
2821622|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821586|NCT00372112|Secondary|Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time|A 12-lead ECG was recorded on Day 1, 2, 7, 8, 14 and 15 with the participant in a supine position having rested in that position for at least 5 min before each reading. A total of 3 measurements separated by at least 1 min was taken at each visit and the mean recorded. The Baseline for pre-dose QTcF and QTcB measurements was the pre-dose assessment on Day 1. Weighted mean at 0-4 h for QTcF and QTcB was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB. The change from Baseline in maximum QTcF and QTcB at 0-4 h was calculated by subtracting the Baseline (pre-dose Day 1) value from the individual post-Baseline values.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
2821587|NCT00372112|Secondary|Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM|BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2821588|NCT00372112|Secondary|Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time|BP was measured using 28.5 h ABPM. Maximum SBP and minimum DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. For the calculation of 0-4 h maximum/minimum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1 for SBP and DBP. Maximum/minimum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1 for SBP and DBP) from the maximum/minimum assessment value (during 0-4 h) of the individual post-Baseline time points.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2821589|NCT00372112|Secondary|Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time|BP was measured using 28.5 h ABPM. Weighted mean SBP and DBP at 0-4 h post-dose was obtained on Day 1, 2, 7, 8, 14 and 15. Weighted mean SBP and DBP at 0-24 h post-dose was obtained on Day 1, 7 and 14. Weighted mean was calculated by calculating the AUC, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. Baseline was defined as the weighted mean SBP and DBP on pre-dose Day 1. The weighted mean change from Baseline was the AAUCMB. Data is reported for change from Baseline in weighted mean pre-dose values at Day 7 and Day 14; change from Baseline in weighted mean over 0-4 h at Day 1, 2, 7, 8, 14 and 15; and change from Baseline in weighted mean over 0-24 h at Day 1, 7 and 14.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2821590|NCT00372112|Secondary|Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14|HR was measured using 28.5 h ABPM. The assessments for maximum HR were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
2821591|NCT00372112|Secondary|Mean Hourly HR 0-24 h at Day 1, 7 and 14|HR was measured using 28.5 h ABPM. The assessments were analyzed hourly as 0-1 h, 1-2 h, 2-3 h, 3-4 h, 4-5 h, 5-6 h, 6-7 h, 7-8 h, 8-9 h, 9-10 h, 10-11 h, 11-12 h, 12-13 h, 13-14 h, 14-15 h, 15-16 h, 16-17 h, 17-18 h, 18-19 h, 19-20 h, 20-21 h, 21-22 h, 22-23 h and 23-24 h at Day 1, Day 7 and Day 14.|Day 1 up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
2821592|NCT00372112|Secondary|Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM|HR was measured using 28.5 h ABPM. Weighted mean HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Weighted mean HR at 0-24 h was obtained from measurements made 0-24 h post-dose on Day 1, 7 and 14. Maximum HR at 0-4 h was obtained from measurements made over 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15. Baseline was defined as the pre-dose weighted mean of Day 1.|Day 1 up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
2821593|NCT00372112|Secondary|Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15|HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). For the calculation of 0-4 h maximum change from Baseline, measurements post-dose up to 6 h (actual time) was included. Baseline was defined as the pre-dose weighted mean of Day 1. Maximum change from Baseline was calculated by subtracting the Baseline value (weighted mean pre-dose Day 1) from the maximum assessment value (during 0-4 h) of the individual post-Baseline time points.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Error|Least Squares Mean
2821594|NCT00372112|Secondary|Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14|HR was measured using 28.5 h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-24 h post-dose on Day 7 and 14, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
2821632|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on Proteinuria were included in this analysis.|||mg/mg||Standard Deviation|Mean
2821595|NCT00372112|Secondary|Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15|HR was measured using 28.5 h ABPM on Day 1 (continued till Day 2), Day 7 (continued till Day 8) and Day 14 (continued till Day 15). Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the AUC of measurements made 0-4 h post-dose on Day 1, 2, 7, 8, 14 and 15 and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the AAUCMB.|Baseline (Day 1, pre-dose) up to Day 15|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Error|Least Squares Mean
2821596|NCT00372112|Secondary|Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14|HR was measured using 28.5h ABPM on Day 1, Day 7 and Day 14. Baseline was defined as the pre-dose weighted mean of Day 1. Weighted mean was calculated by calculating the area under curve (AUC) of measurements made pre-dose on each day, and then dividing by the relevant time interval. AUC was calculated using the trapezoidal rule. The weighted mean change from Baseline was the average AUC minus Baseline (AAUCMB).|Baseline (Day 1, pre-dose) up to Day 14|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
2821597|NCT00372112|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Follow-up (17 days)|Safety Population comprised of all participants who were randomized and received at least one dose of study medication.|||Participants|||Count of Participants
2821598|NCT00372060|Other Pre-specified|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52|Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.|Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.|The Completers Population (CP) includes all randomized patients who took at least 1 dose of sitagliptin and had [1] a baseline (Sitagliptin/Sitagliptin group) or Week 12 (Placebo/Sitagliptin group) value and [2] a value at Week 52.|||Percent||95% Confidence Interval|Mean
2821599|NCT00372060|Other Pre-specified|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 weeks|Analysis in the Full Analysis Set without Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline values.).|||mg/dL||95% Confidence Interval|Least Squares Mean
2821600|NCT00372060|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)|||mg/dL||95% Confidence Interval|Least Squares Mean
2821601|NCT00372060|Primary|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)|||Percent||95% Confidence Interval|Least Squares Mean
2821602|NCT00371865|Secondary|Pain Anxiety Symptom Scale - 20|This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2821603|NCT00371865|Secondary|Beck Depression Inventory|This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2821604|NCT00371865|Secondary|SF-12|This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2821605|NCT00371865|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2821606|NCT00371865|Primary|Brief Pain Inventory|This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.|12 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
2821607|NCT00371839|Primary|Ability to Understand Speech in Noise Background|Measure speech perception for sentences in background noise|one year||||Percent correct of 100 presented words||Standard Deviation|Mean
2821608|NCT00371826|Secondary|Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)|Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.|Week 2, Month 24|Safety population extension (SAF-EX): All patients who entered the extension period, who were treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with week 2 and month 24 assessment for this analysis were included.|||g/cm^2||Standard Deviation|Mean
2821609|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821611|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication|||Participants|||Number
2821612|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821613|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821614|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821615|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall Post Baseline up to month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with serum lipid assessment anytime post baseline up to 36 month were included .|||Participants|||Number
2821616|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall post baseline up to month 12|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with serum lipid assessment anytime post baseline up to 12 month were included in this analysis.|||Participants|||Number
2821617|NCT00371826|Secondary|Number of Participants With Any Wound Problems (36 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.|||Participants|||Number
2821618|NCT00371826|Secondary|Number of Participants With Wound Problems(12 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821619|NCT00371826|Secondary|Number of Participants With Employment Status (36 Months Analysis)|"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other"|At screening (at day 0 +/- 7 days ), At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821620|NCT00371826|Secondary|Number of Participants With Employment Status (12 Months Analysis)|"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other"|At screening (at day 0 +/- 7 days ), At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821621|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.|||Participants|||Number
2821623|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 24|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug. Patients with completed SF-36 assessment were included in this analysis.|||units on a scale||Standard Deviation|Mean
2821624|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Only those patients who had completed the QoL assessment for Month 12 were included in this analysis.|||units on a scale||Standard Deviation|Mean
2821625|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (36 Months Analysis)||Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.|||participants|||Number
2821626|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (12 Months Analysis)||Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||participants|||Number
2821627|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post baseline up to Month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with baseline and overall post baseline up to month 36 assessment were included.|||Participants|||Number
2821628|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post-baseline up to 12 month|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with baseline and overall post baseline up to 12 month assessment for this analysis were included.|||Participants|||Number
2821629|NCT00371826|Secondary|Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)|"The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL~Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.|||Participants|||Number
2821630|NCT00371826|Secondary|Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)|"The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions~Hemoglobin subtype A1c (HbA1c) > 6.5%~Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on PTDM were included in this analysis.|||Participants|||Number
2821631|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment in extension period. This also includes all patients who were randomized but were not treated with study medication. Patients with ACR data at particular time point were included for analysis.|||mg/mmol||Standard Deviation|Mean
2821870|NCT00370331|Secondary|Percentage of Participants Initiating Rescue Treatment On-therapy|Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy.|Anytime from Day 1 to Week 26|All participants randomized to receive placebo or eltrombopag treatment|||Percentage of participants|||Number
2821633|NCT00371826|Secondary|Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine clearance were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.|||mL/min||Standard Deviation|Mean
2821634|NCT00371826|Secondary|Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on creatinine clearance were included in this analysis.|||mL/min||Standard Deviation|Mean
2821635|NCT00371826|Secondary|Mean Serum Creatinine (36 Months Analysis)||At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine serum creatinine were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.|||umol/L||Standard Deviation|Mean
2821636|NCT00371826|Secondary|Mean Serum Creatinine (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on serum creatinine were included in this analysis.|||umol/L||Standard Deviation|Mean
2821637|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.|||Participants|||Number
2821638|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.|||Participants|||Number
2821639|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)|"Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data available at month 36 were included in this analysis.|||Participants|||Number
2821640|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)|"A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.|||Participants|||Number
2821871|NCT00370331|Secondary|Summary of Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits|ITT Population|||platelets/microliter (ul)||Full Range|Median
2821641|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821642|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821643|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821644|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.|||Participants|||Number
2821645|NCT00371826|Secondary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Missing values were imputed by last observation carried forward (LOCF) using values beyond Month 6|||mL/min per 1.73 m^2||Standard Error|Mean
2821646|NCT00371826|Primary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 12|Modified intent-to-treat (mITT)-Add population: All ITT patients who had a calculated GFR value recorded at Month 12 post-randomization including those collected after discontinuation of study medication and retrospectively collected creatinine and urea data|||mL/min per 1.73 m^2||Standard Deviation|Mean
2821647|NCT00371787|Primary|Neovascularization|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|9 month||||mm||Standard Deviation|Mean
2821648|NCT00371787|Primary|Neovascularisation|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|baseline||||mm||Standard Deviation|Mean
2821649|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|9 month||||logMAR||Standard Deviation|Mean
2821650|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|baseline|Per Protocol. Only the data from participants who completed all study visits were analyzed.|||logMAR||Standard Deviation|Mean
2821651|NCT00371761|Primary|Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response|"Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive.~Virological response was defined as having < 10^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction).~Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L."|At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks]||||Participants|||Number
2821652|NCT00371683|Secondary|Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
2821827|NCT00370682|Secondary|Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines|"Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent.~PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7"|post dose 1 and 2||||% of subjects||95% Confidence Interval|Number
2821653|NCT00371683|Secondary|Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period|Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
2821654|NCT00371683|Secondary|Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
2821655|NCT00371683|Secondary|Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.|||participants|||Number
2821656|NCT00371683|Secondary|Mean Change From Baseline in Heart Rate During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had heart rate measurements at baseline were summarized.|||bpm||Standard Error|Mean
2821657|NCT00371683|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had blood pressure measurements at baseline were summarized.|||mmHg||Standard Error|Mean
2821658|NCT00371683|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)|All participants who received at least 1 dose of study drug during the Treatment Period.|||participants|||Number
2821659|NCT00371683|Secondary|Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period|A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients.|Post last dose of study drug to Day 72 (60 days)|Participants who received at least one dose of study drug and entered the Follow-Up period|||percentage of participants||95% Confidence Interval|Number
2821660|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.|Last dose of study drug to Day 72 (60 days)|All participants who received at least 1 dose of study drug during the Treatment Period and entered the Follow-Up Period.|||percentage of participants||95% Confidence Interval|Number
2821828|NCT00370682|Secondary|Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.|Number of subjects with incidence of suspected and confirmed dengue throughout the entire study period.|9 months||||Participants|||Count of Participants
2821661|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days.|First dose of study drug to last dose, plus 2 days post last dose|All participants who received at least one dose of study drug (Treated population).|||percentage of participants||95% Confidence Interval|Number
2821662|NCT00371683|Secondary|Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period|ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From first dose to last dose, plus 2 days (12 days, plus 2)|All participants who received at least one dose of study drug were analyzed (Treated Population).|||percentage of participants||95% Confidence Interval|Number
2821663|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period|ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal (or distal, as appropriate) venogram or an adjudicated event associated with the endpoint. n= number analyzed|||percentage of participants||95% Confidence Interval|Number
2821664|NCT00371683|Secondary|Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants: PE, Symptomatic DVT, Symptomatic Proximal DVT, Symptomatic Distal DVT. Randomized with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint: All DVT, Asymptomatic DVT. n=number analyzed in each category|||percentage of participants||95% Confidence Interval|Number
2821665|NCT00371683|Secondary|Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821666|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821667|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821668|NCT00371683|Secondary|Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821669|NCT00371683|Secondary|Event Rate for Participants With All-Cause Death During the Intended Treatment Period|Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All Randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821670|NCT00371683|Secondary|Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821671|NCT00371683|Secondary|Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821829|NCT00370682|Secondary|Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose|Incidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose|31 days post-vaccination per dose||||% of subjects||95% Confidence Interval|Number
2821672|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821673|NCT00371683|Secondary|Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period|VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821674|NCT00371683|Secondary|Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period|A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2821675|NCT00371683|Primary|Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects|An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization.|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period.|||percentage of participants||95% Confidence Interval|Number
2821676|NCT00371644|Primary|PTSD Checklist (PCL)|The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.|Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment|Numbers differ from enrollment due to participants excluded from data analysis for poor psychotherapeutic fidelity.|||units on a scale||Standard Error|Mean
2821677|NCT00371631|Secondary|The Rate of Symptomatic UTI While Colonized|Symptomatic UTI was defined as significant bacteriuria (≥105 cfu/ml) and pyuria (>10 WBC/hpf) plus ≥1 of the following signs and symptoms for which no other etiology could be identified: fever (oral temperature >100°F), suprapubic or flank discomfort, bladder spasm, change in voiding habits, increased spasticity, or worsening dysreflexia. The rate of UTI (number) was calculated by dividing the total number of patient days by the total number of UTIs.|3 years||||UTI/per subject year|||Number
2821678|NCT00371631|Primary|Bladder Colonization|Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for > 3 days after catheter removal.|> 3 days, up to 197 days||||percentage of participants|||Number
2821679|NCT00371566|Secondary|Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821680|NCT00371566|Secondary|Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821681|NCT00371566|Secondary|Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821682|NCT00371566|Secondary|Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821683|NCT00371566|Secondary|Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821684|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821685|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821686|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821687|NCT00371566|Secondary|Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821872|NCT00370331|Primary|Percentage of Responders|The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment|Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment|Intent-to-Treat (ITT) Population: all randomized participants|||Percentage of participants|||Number
2821688|NCT00371566|Secondary|Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821689|NCT00371566|Secondary|Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821690|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population|||Percent change||Standard Deviation|Mean
2821691|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 5 are death related to Adverse Event."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
2821692|NCT00371566|Secondary|Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 4 are life-threatening or disabling Adverse Event (complicated by acute, life-threatening metabolic or cardiovascular complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
2821693|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 3 are severe and undesirable Adverse Event (significant symptoms requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
2821694|NCT00371566|Secondary|Summary of Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
2821695|NCT00371566|Secondary|Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After the Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
2821696|NCT00371566|Secondary|Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group|Definition of an adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 1 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.|||Participants|||Number
2821723|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Negative|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart|||||||
2821697|NCT00371566|Secondary|Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|weeks 19 - 25|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821698|NCT00371566|Secondary|Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821699|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase|Toxicity Grading scale 0=none, 1= transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 10 through 25|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
2821700|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase|Toxicity Grading scale 0=none, 1=transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 1 through Week 6|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
2821701|NCT00371566|Secondary|Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase|"Tumor Suppressor p53 is welcomed and described as the guardian angel gene, it conserves stability by preventing genome mutation. Human Papillomavirus (HPV) biomarker is un-welcomed and is found to be an important precursor cancers of the head and neck. HPV biomarkers have the ability to bind to and inactivate the Tumor Suppressor p53 biomarker."|Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821702|NCT00371566|Secondary|Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase|Estrogen Receptor (ER) variants, ERB-B2 and ERB B-5 consist of the major proportion of ER expression both in normal and cancer tissues. The exact role of these markers are unknown. Acronyms defined: ICH (immunohistochemical) and FISH (fluorescence in situ hybridization).|Baseline and Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821703|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after chemoradiotherapy numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Chemoradiotherapy (week 10 - 13)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821704|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Treatment (week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821705|NCT00371566|Secondary|Number of Circulating Tumor Cells at Baseline in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's)Pre-Treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|Baseline|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. mITT FOLLOW-UP Population of Circulation Tumor Cells|||Participants|||Number
2821706|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in ITT Population|Over all: Complete Response (CR) - absence of lesions. Partial Response (PR) - CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)- no PD or Response. Progressive Disease (PD)- PD or new lesions. Not Evaluable(NE)- no other definitions.|Baseline and End of Follow-up (week 19 - 25)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
2821707|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in ITT Population|Over all: Complete Response (CR)-absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)-no PD or Response. Progressive Disease (PD)-PD or new lesions. Not Evaluable(NE)- no other definitions.|Baseline and End of Treatment (Week 2 - 6)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Participants|||Number
2821708|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in mITT Population|Over all: Complete Response(CR)-absence of lesions. Partial Response(PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD)in other lesions with no new lesions or progressive disease (PD). Stable Disease(SD)-no PD or Response. Progressive Disease(PD)-PD or new lesions. Not Evaluable(NE)- no other definitions. Number of subjects included those who were considered evaluable if they completed a full course of chemoradiotherapy and were able to provide a baseline and follow-up scan following the completion of chemoradiation.|Baseline and End of Follow-up (Week 19 - 25)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821709|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in mITT Population|Over all: Complete Response (CR)- absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)-no PD or Response. Progressive Disease (PD)-PD or new lesions. Not Evaluable(NE)- no other definitions. Number of subjects included those who had a scan immediately post lapatanib/placebo monotherapy.|Baseline and End of Treatment (Week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.|||Participants|||Number
2821710|NCT00371566|Secondary|Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase|"The Ki-67 protein is expressed in all phases of the cell cycle except G0 (low level phase) and serves as a good marker for cell proliferation. Scoring is assessed by point counting 500 to 1000 cells, and is reported as percent positive cells. 20% positive cells to define positive (i.e. high risk)"|Baseline and Week 2|The mITT (modified Intent-to-Treat) population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumor biopsy sample for the primary endpoint analysis.|||Percent of positive cells||Standard Deviation|Mean
2821711|NCT00371566|Primary|Change From Baseline of the Apoptotic Index During Treatment Phase|Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A 'responder' was defined as having 20% cell death.|Baseline and Week 2|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.|||Percentage of positive cells||Standard Deviation|Mean
2821712|NCT00371540|Secondary|Death||12 months||||participants|||Number
2821713|NCT00371540|Primary|Lost to Follow-up|Number of Subjects Lost to follow-up|12 months||||participants|||Number
2821714|NCT00371540|Secondary|Viral Load|Detectable VL at 12 months|12 months||||participants|||Number
2821715|NCT00371462|Primary|Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I)|Study was terminated by VA. No VA outcome data to report.|baseline, 3, 6, 9, and 12 months|No data were analyzed due to termination of the study.||||||
2821716|NCT00371449|Secondary|Speech Spatial and Qualities of Hearing Scale (SSQ)|The SSQ measures hearing abilities related to speech, spatial perception, and quality of sound using a 1-10 scale. Items are averaged across the test. Higher scores indicate better outcomes.|aided (after wearing hearing aids for at least 3 months)||||units on a scale (points)||Standard Deviation|Mean
2821717|NCT00371449|Secondary|Satisfaction With Amplification in Daily Life (SADL)|Measures how satisfied listeners are with their current hearing aids. Total scale scores are computed by averaging the subscale (positive effect, negative features, personal image, and service & delivery) scores that range from 1 (no satisfaction) to 7 (high satisfaction).|aided (after wearing hearing aids for at least 3 months)||||units on a scale (points)||Standard Deviation|Mean
2821718|NCT00371449|Secondary|Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)|Measures hearing-aid self-efficacy over four subscales (basic handling, advanced handling, adjustment, and aided listening). Subscale scores are averaged to produce a total self-efficacy scores that can range from 0 (low self-efficacy) to 100 (high self-efficacy).|aided (after wearing hearing aids for at least 3 months)||||% level of self-efficacy||Standard Deviation|Mean
2821719|NCT00371449|Secondary|International Outcomes Inventory for Hearing Aids (IOI-HA)|Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.|aided (after wearing hearing aids for at least 3 months)||||units on a scale (points)||Standard Deviation|Mean
2821720|NCT00371449|Secondary|Acceptable Noise Level Test|"The ANL consists of a speech signal and a competing noise signal. The speech signal is a continuous monologue (Arizona Travelogue) by a male talker and the competing noise signal is the 12-talker babble from the Speech in Noise (SPIN) test (Kalikow et al, 1977). The speech and babble stimuli are recorded on separate channels on a compact disc (CD; Cosmos, Inc.). The task of the listener was to adjust the level of the travelogue to the most comfortable level (MCL) and then to adjust the level of the babble to the level the listener is willing to put up with and still follow the travelogue, or to the background noise level (BNL). The ANL (in dB) is the difference between the MCL and BNL."|aided (after wearing hearing aids for at least 3 months)||||dB||Standard Deviation|Mean
2821721|NCT00371449|Primary|Words-in-noise Test|The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.|aided (after wearing hearing aids for at least 3 months)||||dB S/N||Standard Deviation|Mean
2821722|NCT00371436|Primary|THI (Tinnitus Handicap Inventory)|The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.|Baseline, 6 months|The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.|||scores on a scale||Standard Deviation|Mean
2821724|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Positive|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart|||||||
2821725|NCT00371397|Secondary|Blood Pressure||7:55 at each of the three visits, scheduled at least 2 weeks apart|||||||
2821726|NCT00371397|Secondary|Heart Rate||Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15|||||||
2821727|NCT00371397|Primary|Catecholamine Production: Norepinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05|||||||
2821728|NCT00371397|Primary|Catecholamine Production: Epinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart|||||||
2821729|NCT00371397|Primary|Immune Function: Interleukin-6 (IL-6)|Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions|Day 1 8:30, 11:35, 13:10. Day 2 7:30|||||||
2821730|NCT00371397|Primary|Immune Function: LPS-stimulated Production of TNF-α|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30|||||||
2821731|NCT00371397|Primary|Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30|||||||
2821732|NCT00371397|Primary|Immune Function: Tumor Necrosis Factor-alpha (TNF-α)|Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30|||||||
2821733|NCT00371397|Primary|Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)|Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30|||||||
2821734|NCT00371397|Primary|Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)|Cellophane tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, was used to examine whether the time necessary for recovery from minor physical insults varied by condition or yoga expertise. Measurement of the rate of transepidermal water loss (TEWL) through human skin provides a noninvasive method to monitor changes in the skin's barrier function. TEWL was measured twice during the session using a computerized evaporimetry instrument, the DermaLab® (CyberDERM, Media, PA), and barrier recovery was calculated.|11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart|||||||
2821735|NCT00371397|Primary|Cortisol|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30|||||||
2821736|NCT00371397|Primary|Number of Participants With Detectable C-Reactive Protein (CRP)|High sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.|8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart||||participants with CRP above 0.3|||Number
2821737|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 5 of treatment|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
2821738|NCT00371345|Primary|Best Overall Response|Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||participants|||Number
2821739|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
2821740|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|Week 5|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
2821741|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis|||percent change||90% Confidence Interval|Mean
2821742|NCT00371345|Secondary|PK: Plasma Concentration of Dasatinib at Week 7 or Week 9|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis|||ng/ml||Standard Deviation|Mean
2821743|NCT00371345|Secondary|Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis|||ng/ml||Standard Deviation|Mean
2821744|NCT00371345|Secondary|Number Of Participants With Notable Drug-related AEs|Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
2821745|NCT00371345|Secondary|Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
2821746|NCT00371345|Secondary|Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities|Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
2821747|NCT00371345|Secondary|Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.|||participants|||Number
2821748|NCT00371345|Secondary|Duration Of Objective Response|Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.|the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed|Of 69 response-evaluable participants, three had an objective response of PR.|||weeks|||Number
2821749|NCT00371345|Secondary|Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25|PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.|At Weeks 9, 17, and 25|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||percentage of participants|||Number
2821750|NCT00371345|Secondary|Median Progression Free Survival (PFS)|PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.|||weeks||95% Confidence Interval|Median
2821751|NCT00371345|Secondary|Number of Participants Who Progressed|PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.|||participants|||Number
2821796|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|3 month follow-up||||units on a scale||Standard Deviation|Mean
2821752|NCT00371345|Secondary|Percentage of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||percentage of participants||95% Confidence Interval|Mean
2821753|NCT00371345|Secondary|Number of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||participants|||Number
2821754|NCT00371345|Primary|Percentage of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).|||percentage of participants||95% Confidence Interval|Number
2821755|NCT00371345|Primary|Number of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment. One participant was not evaluable (no on-study tumor assessment for other reason).|||participants|||Number
2821756|NCT00371293|Secondary|Change in HDL Cholesterol Levels||Measured at Baseline and Week 24||||mg/dL||95% Confidence Interval|Mean
2821757|NCT00371293|Secondary|Change in Triglyceride Levels||Measured at Baseline and Week 24||||mg/dL||95% Confidence Interval|Mean
2821758|NCT00371293|Secondary|Change in LDL Cholesterol Levels||Measured at Baseline and Week 24||||mg/dL||95% Confidence Interval|Mean
2821759|NCT00371293|Secondary|Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min−1/μU/ml)|Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman's minimal model.|Measured at Baseline and Week 24||||x10-4/min−1/μU/ml||95% Confidence Interval|Mean
2821760|NCT00371293|Primary|Inflammation||Measured at Baseline and Week 24||||percentage of change in crp at week 24||95% Confidence Interval|Mean
2821761|NCT00371267|Secondary|Pain Intensity Rating|Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2821762|NCT00371267|Secondary|Pain Behavior Checklist Total Score|Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2821763|NCT00371267|Primary|Short Form-12 Mental Health|Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2821764|NCT00371267|Secondary|Beck Depression Inventory (BDI)-2 Total Score|Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2821765|NCT00371267|Primary|Short Form-12 Physical Health|Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores|46 weeks|Veterans with chronic pain|||units on a scale||Standard Deviation|Mean
2821766|NCT00371254|Secondary|Number of Participants With Abnormal Vital Signs Measurements|Vital signs included systolic and diastolic blood pressure and heart rate. The investigator used his or her judgement to decide whether or not the values were abnormal.|At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)|All treated participants|||participants|||Number
2821767|NCT00371254|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECGs were performed and all recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed. The following ECG variables were collected: heart rate, PR interval, QRS width, and QT interval. Abnormalities in ECGs were defined by reference to institutional reports.|Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).|All treated participants|||participants|||Number
2821768|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Creatinine: Grade 3-4 : > 3.0 -6.0 ULN (upper limit of normal),Bicarbonate: Grade 3-4: <16 -<22 mEq/L, Phosphorous: Grade 3-4 : <1.0 - <2.0 mg/dL, Bilirubin, total: Grade 3-4: >3.0 - >10.0 ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821797|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Post Intervention||||units on a scale||Standard Deviation|Mean
2821769|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Calcium: Grade 3-4 : <6.0 - <7.0 or >12.5 - >13.5 mg/dL, Potassium: Grade 3-4 : <2.5 - <3.0 or >6.0 - >7.0 mEq/L, Magnesium: Grade 3-4 : <0.6 - <0.8 or >2.46 - >6.6 mEq/L, Sodium:< 120- 130 or >155 - >160 mEq/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821770|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: ALT, AST and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821771|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)|PTT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants.|||Participants|||Number
2821772|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)|PT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821773|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grades 3 and 4 criteria are defined as follows: Granulocytes: Grade 3 <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Hemoglobin: Grade 3, <8.0 - 6.5 g/dL; Grade 4, <6.5 g/dL. Platelets: Grade 3, <50.0 - 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Leukocytes: Grade 3, <2.0 - 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821774|NCT00371254|Secondary|Most Frequent Drug-related Adverse Events (AEs)|Most frequent drug-related AEs are those AEs with frequency >=25% in either group. Drug-related AEs are those events with relationship to study therapy of certain, probable or possible.|From start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821775|NCT00371254|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs|AE=any new untoward medical occurrence/worsening of pre-existing medical condition.SAE=AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event. Drug-related SAEs or AEs are those events with relationship to study therapy of certain, probable or possible.AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), v3: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants|||participants|||Number
2821776|NCT00371254|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.|||participants|||Number
2821777|NCT00371254|Secondary|Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity|Pharmacogenomic analysis included the assessment of the relationship between clinical benefit and mRNA expression levels and between clinical benefit and protein phosphorylation. Tumor mRNA expression was analyzed in all available tissues. mRNA was extracted from 96 formalin-fixed paraffin-embedded tissue (FFPET) samples, amplified, and fluorescently labeled. Gene expression profiling was conducted using Affymetrix Human Genome U133A 2.0 DNA microarrays. mRNA expression is reported as quantile normalized RMA values.|Baseline|All treated participants who were evaluable for the analysis. These data for pharmacogenomic analyses were integrated with those from other studies and are not reportable for this study alone.|||log2 scale (unitless)|||Number
2821778|NCT00371254|Secondary|Percentage Change in Tumor Biomarkers|Tumor markers are indicators of tumor activity which may be used to predict clinical benefit and circulating biomarkers may reveal key mechanisms of action. Tissue staining was performed for caveolin, phospho-caveolin, EphA2 and insulin-like growth factor binding protein 2 (IGFBP2) markers using immunohistochemistry assays.|Baseline|All treated participants who were evaluable for the analysis. These data for tumor markers were integrated with those from other studies and are not reportable for this study alone.|||percentage||Inter-Quartile Range|Median
2821779|NCT00371254|Secondary|Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline|VEGFR2 is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of VEGFR2 were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.|||percentage of baseline||90% Confidence Interval|Geometric Mean
2821780|NCT00371254|Secondary|Mean Change in Concentration of Collagen Type IV From Baseline|Collagen Type IV is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of Collagen Type IV were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.|||percentage of baseline||90% Confidence Interval|Geometric Mean
2821781|NCT00371254|Secondary|Mean Plasma Concentration at Week 7|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."|||nanograms (ng)/mL||Standard Deviation|Mean
2821782|NCT00371254|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset.|||percentage of participants||95% Confidence Interval|Number
2821783|NCT00371254|Secondary|Mean Plasma Concentration at Week 3|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."|||nanograms (ng)/mL||Standard Deviation|Mean
2821784|NCT00371254|Secondary|Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)|Mean number of weeks of CR/PR (time from first date of CR/PR until first date PD observed. Tumor response defined per RECIST: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in sum of LDs of target lesions relative to baseline sum LD; PD: appearance of new lesion or >=20% increase in sum of LD of target lesions relative to smallest sum LD or unequivocal progression of existing non-target lesions. Participants who died without reported PD were considered to have PD on date of death. For participants who neither progressed nor died, date of last tumor assessment used.|Baseline to end of study drug therapy (up to 53.86 weeks)|Response-evaluable participants who achieved a complete response (CR) or partial response (PR)|||weeks||Full Range|Mean
2821785|NCT00371254|Secondary|Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25|PFS:time from first dose until the date that progressive disease (PD) or clinical PD (cPD) observed,per RECIST criteria.PD:appearance of new lesion/s,or >=20% increase in the sum of the LD of target lesions,relative to smallest sum LD recorded since treatment start,or unequivocal progression of existing non-target lesions;cPD:deterioration related to disease requiring treatment discontinuation,but without radiographic PD.Participants who died without PD were considered to have PD on the date of death.For participants who neither progressed nor died,date of the last tumor assessment was used.|Weeks 9, 17, and 25|All treated participants|||Proportion of Participants|||Number
2821786|NCT00371254|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The percentage of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.|||percentage of participants||95% Confidence Interval|Number
2821787|NCT00371254|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The number of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks.|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.|||Participants|||Number
2821788|NCT00371254|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.|||participants|||Number
2821789|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|6 month follow-up||||units on a scale||Standard Deviation|Mean
2821790|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|3 month follow-up||||units on a scale||Standard Deviation|Mean
2821791|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Post intervention||||units on a scale||Standard Deviation|Mean
2821792|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Pre intervention||||units on a scale||Standard Deviation|Mean
2821793|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|6 month follow-up||||units on a scale||Standard Deviation|Mean
2821794|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|3 month follow-up||||units on a scale||Standard Deviation|Mean
2821795|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|6 month follow-up||||units on a scale||Standard Deviation|Mean
2821801|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry|The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:>1.25xULN, Aspartate aminotransferase:>1.25xULN, Alkaline Phosphatase:>1.25xULN, Total Bilirubin:>1.1xULN, Serum Lipase:>1.10xULN, Creatinine:>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.|||participants|||Number
2821802|NCT00371150|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately <300 copies/mL.|Week 48 of ETV treatment|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants||95% Confidence Interval|Number
2821803|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology|Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.|||participants|||Number
2821804|NCT00371150|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 52 + 5 days|All treated participants.|||participants|||Number
2821805|NCT00371150|Secondary|Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis||Week 48|Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.|||percentage of participants|||Number
2821806|NCT00371150|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.|baseline, Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.|||log10 IU/mL||Standard Error|Mean
2821807|NCT00371150|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
2821808|NCT00371150|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
2821809|NCT00371150|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
2821810|NCT00371150|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.|||percentage of participants|||Number
2821811|NCT00371150|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants|||Number
2821812|NCT00371150|Secondary|Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV|Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)|through Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.|||percentage of participants|||Number
2821813|NCT00371150|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants|||Number
2821814|NCT00371150|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.|||percentage of participants||95% Confidence Interval|Number
2821815|NCT00371137|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14||||Percentage of Participants|||Number
2821816|NCT00370994|Secondary|Functional Status|Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.|3, 6, 12, 18 and 24 months post treatment.||||units on a scale||Standard Deviation|Mean
2821817|NCT00370994|Primary|Numeric Pain Rating Score|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable|3, 6, 12, 18 and 24 months post treatment.|Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.|||units on a scale||Standard Deviation|Mean
2821818|NCT00370838|Primary|Total Tic Score|The TTS is a portion of the YGTSS [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). A score of 0 represent no tics present, a score of 50 represents the most severe tics in each category listed.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
2821819|NCT00370838|Secondary|Modified Pittsburgh Side Effect Scale|"Side effects will be assessed by an expanded (modified) Pittsburgh Side Effect Scale modified to include side effects of levetiracetam and clonidine. Significant adverse events will be reported to the UCB, JCCI, and FDA within 24 hours. Positive responses are tallied as number of side effects for the responding period."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||Number of Side Effects||Standard Deviation|Mean
2821820|NCT00370838|Secondary|Multidimensional Anxiety Scale for Children (MASC):|"The child's anxiety will be followed using the multidimensional Anxiety Scale for Children (MASC) (Stallings and March, 1995) and is now considered the preferred instrument for rating childhood anxiety. It is a 39-item questionnaire, ranking each item as Never, Rarely, Sometimes, or Often (0, 1, 2, 3). The sum of all responses yeilds a score (maximum MASC score is 117). A score of 0 represents no anxiety, and a score of 117 represents severe anxiety."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
2821821|NCT00370838|Secondary|DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale:|The presence of Attention Deficit Hyperactivity Disorder (ADHD) symptoms are assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) version of the DuPaul ADHD rating scale, which incorporates the symptom items for ADHD from the DSM into a rating scale format that quantifies symptom severity. Each item is rated as not at all, just a little, pretty much, and very much (0, 1, 2, and 3). There are 18 items in total are summed, with a minimum score of 0 (meaning no inattention or hyperactivity) with a maximum score of 54 (severe inattention and hyperactivity).|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
2821822|NCT00370838|Secondary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS):|The severity of obsessive-compulsive disorder (OCD) is evaluated using the CY-BOCS [Scahill et al 1997]. Obsessions and compulsions are rated on 5 separate scales yielding three summary scores: Obsessions (0-20), Compulsions (0-20) and Total score (0-40). The CY-BOCS is the most widely used instrument to assess the severity of OCD symptoms in research studies. It includes checklist of specific obsessions and compulsions followed by examiner ratings of time spent, interference, distress, resistance and control over the obsessions and compulsions.0=no obsessions or compulsions; 40=most severe OC|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
2821823|NCT00370838|Secondary|Clinical Global Impression-Improvement (CGI-I):|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to very much improved; 2 equals much improved; 3 denotes minimal change; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals minimally worse; 6 is much worse; and 7 is very much worse."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
2821824|NCT00370838|Primary|Yale Global Tic Severity Scale (YGTSS):|The YGTSS is a semi-structured clinical interview designed to measure current tic severity [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). The YGTSS contains an impairment ranking, 0-50 points, based on the impact of the tic disorder on areas such as self esteem, family life, social acceptance, and school. 0=no tics present; 100=most severe tics.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)||||scores on a scale||Standard Deviation|Mean
2821825|NCT00370682|Secondary|Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose|"Percentage of subjects with incidence of measurable dengue viremia at specified time points after each dose.~Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is >=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7"|within 7 months||||% of subjects|||Number
2821826|NCT00370682|Secondary|Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines|"Seropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects.~PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9"|9 months||||% of subjects||95% Confidence Interval|Number
2821830|NCT00370682|Secondary|Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose|"Laboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges.~PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7"|within 31 days after each vaccine dose||||subjects|||Number
2821831|NCT00370682|Secondary|Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period|Number of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period|9 months||||Participants|||Count of Participants
2821832|NCT00370682|Secondary|Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose|Incidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine|0-30 days after each study vaccine dose||||unsolicited AEs|||Number
2821833|NCT00370682|Secondary|Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine|Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2|0-21 days after dose 2 of study vaccine||||percentage of subjects||95% Confidence Interval|Number
2821834|NCT00370682|Primary|Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2|Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)|30 and 90 days after dose 2||||GMTs||95% Confidence Interval|Mean
2821835|NCT00370682|Primary|Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1|Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)|0-21 days after dose 1||||percentage of subjects||95% Confidence Interval|Number
2821836|NCT00370552|Secondary|Number of Participants With Abnormalities in Renal Function by Worst CTC Grade|Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.|||Participants|||Number
2821837|NCT00370552|Secondary|Number of Participants With Abnormalities in Liver Function by Worst CTC Grade|ULN=Upper limit of normal.ALT Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; AST Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; ALP Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Total bilirubin Gr 1: >ULN to 1.5*ULN, Gr 2: >1.5 to 3.0*ULN, Gr 3: >3.0 to 10.0*ULN, Gr 4: >10.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.|||Participants|||Number
2821838|NCT00370552|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L; Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug.|||Participants|||Number
2821839|NCT00370552|Primary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants|||Participants|||Number
2821840|NCT00370552|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug|All randomized participants who received any study drug.|||Participants|||Number
2821841|NCT00370552|Secondary|Percentage of Participants Surviving at 1 Year|One year survival rates were computed using Kaplan-Meier estimates.|Date first participant enrolled to 1 year|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2821842|NCT00370552|Secondary|Median Duration of Response|Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.|||Months||95% Confidence Interval|Median
2821843|NCT00370552|Secondary|Median Time to Response|Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.|||Weeks||Full Range|Median
2821844|NCT00370552|Secondary|Median Progression-free Survival (PFS)|PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment.|Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)|All randomized participants.|||Months||95% Confidence Interval|Median
2821845|NCT00370552|Secondary|Percentage of Participants With Progression-free Survival at Week 24|Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.|Date of randomization to Week 24|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2821846|NCT00370552|Primary|Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study|CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2821847|NCT00370396|Secondary|Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens|A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL)|One month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2821848|NCT00370396|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers|Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2821849|NCT00370396|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2821850|NCT00370396|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2821857|NCT00370396|Secondary|Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study."|Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2822175|NCT00368459|Secondary|Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes|Global rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
2821851|NCT00370396|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2821852|NCT00370396|Secondary|Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2821853|NCT00370396|Secondary|Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2821854|NCT00370396|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2821855|NCT00370396|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month (Month 1) post booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2821856|NCT00370396|Secondary|Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA)|A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|Prior to (PRE) and one month after (Month 1) booster vaccination|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.|||Participants|||Count of Participants
2821858|NCT00370396|Secondary|Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007."|Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2821859|NCT00370396|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007."|Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2821860|NCT00370396|Secondary|Number of Subjects With Any and Any Grade 3 Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available."|Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..|||Participants|||Count of Participants
2821861|NCT00370396|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available."|Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets..|||Participants|||Count of Participants
2821862|NCT00370396|Primary|Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups|Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature > 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.|Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets.|||Participants|||Count of Participants
2821863|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-72)||Standard Deviation|Mean
2821864|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-24)||Standard Deviation|Mean
2821865|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-52)||Standard Deviation|Mean
2821866|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population|||Points on a scale (0-100)||Standard Deviation|Mean
2821867|NCT00370331|Secondary|WHO Bleeding Scale|Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding|Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits|ITT Population|||Percentage of participants|||Number
2821868|NCT00370331|Secondary|Percentage of Participants With a Reduction in Use of Baseline ITP Medication|Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use|From Day 1 through Week 26 on-treatment|ITT Population|||Percentage of participants|||Number
2821869|NCT00370331|Secondary|Maximum and Total Weeks of Platelet Response|Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter.|Day 1 through Week 26 on-treatment|ITT Population|||Weeks||Full Range|Median
2821873|NCT00370292|Primary|Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|Number of participants who received at least one dose of study drug.|||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
2821874|NCT00370292|Secondary|Best Objective Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response (every 14 days for 6 cycles)|Number of participants who received at least one dose of study drug.|||participants|||Number
2821875|NCT00370292|Primary|Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|All participants who received at least one dose of study drug.|||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
2821876|NCT00370149|Secondary|Death|Patient Death during hospitalization.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.|||participants|||Number
2821877|NCT00370149|Secondary|Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter|A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.|Participants were followed for the duration of hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.|||participants|||Number
2821878|NCT00370149|Primary|Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days|Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.|||participants|||Number
2821879|NCT00370071|Secondary|Percentage of Subjects Without EDSS Progression|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability.The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability. An EDSS progression was defined as increase in EDSS greater than or equal to (>=) 1.0 points (in the treatment period as compared to baseline).|Baseline up to Week 24|FAS|||percentage of subjects|||Number
2821880|NCT00370071|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability. The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability.|Pre-treatment on Day 1, Week 24|FAS subjects with EDSS assessments at the end of the study (Week 24)|||Scores on a scale||Standard Deviation|Mean
2821881|NCT00370071|Secondary|Assessment of Relapses: Relapse Severity|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. A major relapse was defined based on changes on EDSS with the following additional criteria to be met: objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS score or increase of the total EDSS score. Relapses which did not meet the criteria of major relapses were considered as non-major.|Baseline up to Week 24|FAS with all subjects who had reported relapses|||relapses|||Number
2821882|NCT00370071|Secondary|Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment.|After 24 weeks|FAS|||percentage of subjects|||Number
2821883|NCT00370071|Secondary|Assessment of Relapses: Number of Relapses|"A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. In the categories listed below, N signifies the number of subjects evaluable for the timepoints, and same subjects were counted more than once under each category."|3 and 6 months|FAS with all subjects who had reported relapses|||relapses|||Number
2821884|NCT00370071|Secondary|Assessment of Relapses: Relapse Rate|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature more than (>) 37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. The relapse rate was calculated on an annualized basis. Annualized relapse rate is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all subjects in the group divided by the sum of the number of days on study of all subjects in the group and multiplied by 365.25.|Baseline up to Week 24|Full analysis set (FAS)|||relapses per year|||Number
2821885|NCT00370071|Secondary|Number of T2 Lesions at Baseline, Weeks 12 and 24|"In the categories listed below, N signifies the number of subjects evaluable for the timepoints."|Baseline, Weeks 12 and 24|MRS|||Lesions||Standard Deviation|Mean
2821886|NCT00370071|Secondary|Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24|"In the categories listed below, N signifies the number of subjects evaluable for the timepoints."|Baseline, Weeks 12 and 24|MRS|||Lesions||Standard Deviation|Mean
2821887|NCT00370071|Secondary|Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24|"In the categories listed below, N signifies the number of subjects evaluable for the timepoints."|Baseline, Weeks 12 and 24|MRS|||cubic millimeter (mm^3)||Standard Deviation|Mean
2821888|NCT00370071|Secondary|Difference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new or enlarging T2 lesions during the 3-month pre-treatment period from the cumulative number of new or enlarging T2 lesions during the 6-month treatment period divided by 2 (number of new T2 lesions per three months) based on non-enhancing lesions on T1 weighted scans|after 6 months of treatment as compared to the 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.|||lesions||Full Range|Median
2821889|NCT00370071|Secondary|Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new Gd-enhancing lesions during the 3-month pre-treatment period from the cumulative number of new Gd-enhancing lesions during the 6-month treatment period divided by 2 (number of new Gd-enhancing lesions per three months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.|||lesions||Full Range|Median
2821890|NCT00370071|Primary|Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment|The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.|||lesions||Full Range|Median
2821891|NCT00370032|Secondary|Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Population: modified per protocol to include placebo information only.|||ml per minute per 100 grams of tissue||Standard Deviation|Mean
2821892|NCT00370032|Secondary|Rectal Mucosal Blood Flow (MBF)|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period||||ml per minute per 100 grams of tissue||Standard Deviation|Mean
2821893|NCT00370032|Primary|Left Colon Mucosal Blood Flow (MBF)|On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Per Protocol Population - the population used for the primary and secondary outcome analyses. The population consisted of all randomized subjects who completed the study with MBF measurements for both treatment periods.|||ml per minute per 100 grams of tissue||Standard Deviation|Mean
2821894|NCT00369967|Secondary|Patient Satisfaction|Rating of patient satisfaction with method|3, 6, and 12 months|None of the participants returned their satisfaction survey||||||
2821895|NCT00369967|Secondary|Bleeding Profile||3, 6, and 12 months|None of the participants returned their menstrual calendars to assess this outcome||||||
2821896|NCT00369967|Secondary|Pregnancy|Number of pregnancies reported|3,6, and 12 mo|There were no reported pregnancies during the study period|||participants|||Number
2821897|NCT00369967|Primary|Method Continuation at 12 Months|Participants reporting continuation with method at 12 months|12 months|Participants enrolled|||participants|||Number
2821898|NCT00369967|Primary|Method Continuation at 6 Months|Participants reporting continuation of method at 6 months|6 months|Participants enrolled|||participants|||Number
2821899|NCT00369967|Primary|Continuation With the Contraceptive Method|Participants reporting continuation with contraceptive method at 3 months|3 months|Number using method at 3 months|||participants|||Number
2821900|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821901|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821902|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821903|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821904|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821905|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821906|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821907|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821908|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821909|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821910|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821911|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821912|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821913|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821914|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821915|NCT00369941|Secondary|Number of Participants With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821916|NCT00369941|Secondary|Number of Participants With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821917|NCT00369941|Secondary|Number of Participants With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821918|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821919|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821920|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821921|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821922|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821923|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821924|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821925|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821926|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821927|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821928|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821929|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821930|NCT00369941|Secondary|Number of Participants That Died by Week 240|All participant deaths in the span of 240 weeks on study were recorded.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821931|NCT00369941|Secondary|Number of Participants That Died by Week 156|All participant deaths in the span of 156 weeks on study were recorded.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821932|NCT00369941|Secondary|Number of Participants That Died by Week 96|All participant deaths in the span of 96 weeks on study were recorded.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821933|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821934|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821946|NCT00369941|Primary|Number of Participants That Discontinued With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821935|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821936|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821937|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821938|NCT00369941|Primary|Number of Participants Discontinued With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse events (AEs) in this study were defined as drug-related if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821939|NCT00369941|Primary|Number of Participants Discontinued With LAEs at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821940|NCT00369941|Primary|Number of Participants With Serious Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821941|NCT00369941|Primary|Number of Participants With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821942|NCT00369941|Primary|Number of Participants With Serious LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821943|NCT00369941|Primary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2821944|NCT00369941|Primary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821945|NCT00369941|Primary|Number of Participants That Discontinued With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2822844|NCT00362375|Primary|Condom Use During Vaginal Sex With Any Male Partner|Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months|Past 3 months|Women who were sexually active at 3-month follow-up and who provided data on outcome measure|||Percent|||Number
2821947|NCT00369941|Primary|Number of Participants That Discontinued With CAEs at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821948|NCT00369941|Primary|Number of Participants That Died by Week 48|All participant deaths in the span of 48 weeks on study were recorded.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821949|NCT00369941|Primary|Number of Participants With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821950|NCT00369941|Primary|Number of Participants With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821951|NCT00369941|Primary|Number of Participants With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821952|NCT00369941|Primary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821953|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821954|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821955|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821956|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821957|NCT00369941|Secondary|Number of Participants With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821958|NCT00369941|Secondary|Number of Participants With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821959|NCT00369941|Secondary|Number of Participants With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821960|NCT00369941|Secondary|Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8|Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression|8 Weeks|All participants who took study medication were included in the analysis.|||Participants|||Number
2821961|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 240|Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)|Baseline and Week 240|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
2822853|NCT00362297|Secondary|Frequency of Lesional Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per Day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks|||||||
2821963|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821964|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 156|Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)|Baseline and Week 156|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
2821965|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821966|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821967|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)|Baseline and Week 96|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
2821968|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821969|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821970|NCT00369941|Secondary|Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)|Baseline and Week 48|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
2821971|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in this analysis.|||Participants|||Number
2821972|NCT00369941|Primary|Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2821973|NCT00369928|Primary|Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks|percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks|12 weeks||||percent meeting ACR 20||95% Confidence Interval|Number
2821974|NCT00369915|Secondary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety.|Each of 12 sessions.|Only study completers were analyzed.|||units on a scale||Standard Deviation|Mean
2821975|NCT00369915|Primary|Change in Depression Severity|The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression.|Outcome measures obtained at each of 12 sessions|Only participants who completed the trial were included in the analysis.|||units on a scale||Standard Deviation|Mean
2821976|NCT00369824|Secondary|Number of Subjects Reporting Medically Significant Adverse Events (AEs)|Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)||||Participants|||Count of Participants
2821977|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)||||Participants|||Count of Participants
2821978|NCT00369824|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)||||Participants|||Count of Participants
2821979|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day period following each vaccination||||Participants|||Count of Participants
2821980|NCT00369824|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least|||Participants|||Count of Participants
2821981|NCT00369824|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least|||Participants|||Count of Participants
2821982|NCT00369824|Secondary|Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response|"Vaccine responses for anti-A, C, Y and W-135 defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)~For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer"|One month after vaccination with Menactra|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups|||Participants|||Count of Participants
2821983|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN|"Booster responses defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,~For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,~For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.|||Participants|||Count of Participants
2821984|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-D and Anti-T|"Booster responses for anti-D and anti-T defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)~For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||Participants|||Count of Participants
2821985|NCT00369824|Secondary|Concentration of Anti-D and Anti-T Antibodies|Concentrations given as Geometric Mean Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||International Unit per Milliliter||95% Confidence Interval|Geometric Mean
2821986|NCT00369824|Secondary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups|||Participants|||Count of Participants
2821987|NCT00369824|Secondary|Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.|Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13|||Participants|||Count of Participants
2821988|NCT00369824|Primary|Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies|Titers given as Geometric Mean Titers (GMTs)|Before and one month after vaccination with Menactra|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.|||Titer||95% Confidence Interval|Geometric Mean
2821989|NCT00369824|Primary|Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Concentrations given as Geometric Means Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
2821990|NCT00369824|Primary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.|||Participants|||Count of Participants
2821991|NCT00369785|Primary|Memory as Quantified by the HVLT-discrimination|In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.|24 weeks|Number of participants with 24 week memory data|||units on a scale||Standard Error|Least Squares Mean
2821992|NCT00369785|Primary|Memory as Quantified by HVLT-immediate Recall|Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.|24 weeks|Participants with 24 week HVLT data.|||units on a scale||Standard Error|Least Squares Mean
2821993|NCT00369746|Secondary|Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day|This variable reports maximum drinks per drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol|||drinks||Standard Deviation|Mean
2821994|NCT00369746|Secondary|Timeline Follow Back (TLFB) Drinking Days Per 30 Days|This variable reports drinking days in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol|||days||Standard Deviation|Mean
2821995|NCT00369746|Secondary|Quantitative Substance Use Inventory ((SUI)|"Quantitative Substance Use Inventory ((SUI) Measure substance use~Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days"|30 days|All participants who met entry criteria for alcohol abuse or dependence per protocol.|||Days||Standard Deviation|Mean
2821996|NCT00369746|Secondary|Timeline Follow Back (TLFB) Average Drinks Per Drinking Day|This variable reports average drinks/drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol|||drinks per drinking day||Standard Deviation|Mean
2821997|NCT00369746|Primary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range:~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total scoring ranges (0-48):~0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression"|study exit visit, at Week 12|All participants who met entry criteria for alcohol abuse or dependence per protocol.|||units on a scale||Standard Deviation|Mean
2821998|NCT00369707|Post-Hoc|Overall Survival Rate|Overall survival (OS) will be measured from the time of first treatment to death from any cause.|Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, OS rate for all patients is reported at 4 years.||||percentage of patients|||Number
2821999|NCT00369707|Secondary|Progression Free Survival (PFS) Rate|"Progression Free Survival is measured from the time of first induction infusion to disease progression, relapse, second tumor, or death from any cause.~Progressive disease (PD) requires the following:~Appearance of any new lesion or increase by > 50% in the size of previously involved sites.~Increase of > 50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any non measurable disease or nondominant site.~> 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node"|Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS for all patients is reported at 4 years.||||percentage of patients|||Number
2822000|NCT00369707|Secondary|Percentage of Patients With Treatment Failure|Time to Treatment Failure (TTF) rate measured, from the time of first treatment to disease progression, relapse, second tumor, death from any cause, treatment toxicity requiring termination from the study, or for any reason treatment is discontinued permanently.|Median follow up for all patients was 50 months and on intent to treat, TTF rate for all patients is reported at 4 years.||||percentage of patients|||Number
2822001|NCT00369707|Secondary|Correlation of Tumor Burden|"Correlation of tumor burden according to Groupe D'Etude des Lymphomes Follicularies (GELF) with recently developed Follicular Lymphoma International Prognostic Index (FLIPI) prognostic index. All patients enrolled in the study were required to have high tumor burden (HTB) as defined by GELF, where HTB is defined as representing higher risk disease and poorer outcomes than low tumor burden (LTB). Patients were put into low risk or high risk FLIPI groups. Low risk group with a score of 0-2 and high risk group with a score of 3-5.~A FLIPI score of 0 to 1 = low risk with a 10 year overall survival of 70%. A score of 2= intermediate risk with a 10 year overall survival of 50%. Finally, a score of ≥ 3 is considered high risk with a 10 year overall survival of 35%. Data was collected in connection with high or low risk FLIPI and Progression Free Survival (PFS) or Overall Survival (OS) and is reported as percentage patient with high/low risk that are progression free or alive."|At the start of treatment and at Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS and OS for all patients is reported at 4 years.||||percentage of patients|||Number
2822002|NCT00369707|Secondary|Tissue Evaluation|Tissue microarray analysis from paraffin embedded tissue, gene expression profiling from frozen tissue (both from initial node biopsy collected/stored) and whole blood analysis of FCγR polymorphism|At baseline and at response assessment 1 after induction part A, 2, after induction part B and 3, maintenance period.|Insufficient tumor samples were submitted for insufficient number of patients. No data was collected or analyzed.||||||
2822003|NCT00369707|Secondary|Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment|"Assess the safety and tolerance of bortezomib/rituximab as induction and maintenance therapy. Data will be collected for grade 3 and grade 4 adverse events experienced by patients that are determined to be at least possibly related to at least one study drug. Toxicity data for bortezomib/rituximab will be collected on day 1 of every cycle (1 cycle = 35 days) for up to 7 cycles during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of each cycle and at the completion of cycles 1 and 3, during treatment up to 12 months||||Participants|||Count of Participants
2822004|NCT00369707|Secondary|Duration of Overall Response|"The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded)until the first date that recurrent or progressive disease is objectively documented.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.~Progressive disease (PD) requires the appearance of any new lesion or increase by > 50% in the size of previously involved sites."|Every 2 months for up to 12 months then every 6 months for 2 years and annually for 1 year|Data was not collected or analyzed for duration of response.||||||
2822018|NCT00369655|Secondary|Progression Free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.|Time from registration to disease progression or death (up to 5 years)||||Months||95% Confidence Interval|Median
2822005|NCT00369707|Secondary|Overall Response Rate After Completion of Maintenance Therapy|"Overall response rate at completion of bortezomib/rituximab maintenance therapy.~Overall response rate at this time point will be defined as complete response [CR] plus partial response [PR]) after 3 cycles of bortezomib/rituximab induction therapy and up to 4 cycles of maintenance for patients with previously untreated low-grade, B-cell NHL.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen."|At baseline and every 2 months during treatment of up to 3 cycles of induction (1 cycle =35days) and 4 cycles of maintenance (1 cycle =2 months) for up to 12 months.||||percentage of patients|||Number
2822006|NCT00369707|Secondary|Overall Response Rate After 1 Course of Induction Therapy|"Overall response rate (ORR) after 1 cycle of bortezomib/rituximab induction therapy.~Overall response rate at this time point will be defined as complete response [CR] plus partial response [PR]) after 1 cycle of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen."|At baseline and at the completion of cycle 1 (1 cycle =35 days)||||percentage of patients|||Number
2822007|NCT00369707|Primary|Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.|"The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response [CR] plus partial response [PR]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.~Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase [LDH]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present).~Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen."|At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.||||percentage of patients|||Number
2822008|NCT00369681|Secondary|Addition of Information to Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers||5 years|Data pertaining to this outcome was not collected.||||||
2822009|NCT00369681|Secondary|Event-free Survival|Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.|3 years|All evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2822010|NCT00369681|Primary|Relationship Between Marker Detection and Clinical Outcome|Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.|3 years|Only 21 participants had a detectable CD27(+) ALDH(+) clone prior to study intervention. The remaining participants either did not have such a clone or did not have a sample tested to look for a clone.|||relapses|||Number
2822011|NCT00369681|Primary|Effect of Rituximab on EBV(+) Tumors|Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).|Up to 56 months|Only 4 participants had EBV(+) tumors.|||relapses|||Number
2822012|NCT00369668|Primary|Fractionated Reaction Time|Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.|Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.|||milliseconds||Standard Error|Median
2822013|NCT00369668|Primary|Fugl-Meyer Upper Extremity Motor Test|FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.|||units on a scale||Standard Deviation|Mean
2822014|NCT00369668|Primary|Box and Block Test; Data Collected = Number of Blocks Moved|"A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1 x 1 block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box."|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.|||Blocks||Standard Deviation|Mean
2822015|NCT00369655|Secondary|Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events||Up to 5 years|All participants who have received previous treatment with anti-HER2.|||Participants|||Number
2822016|NCT00369655|Secondary|Median Duration of Response|Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|Up to 5 years|Analysis population included only patients who have achieved a confirmed tumor response. The duration of response of 4.6 months is reported from one patient.|||Months||95% Confidence Interval|Median
2822017|NCT00369655|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from registration to death or last follow up (up to 5 years)||||Months||95% Confidence Interval|Median
2822019|NCT00369655|Primary|Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival|The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.|6 months|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.|||Participants|||Number
2822020|NCT00369655|Primary|Proportion of Patients With Confirmed Tumor Response|Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.|Up to 5 years|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.|||Participants|||Number
2822021|NCT00369629|Primary|Maximum Tolerated Dose as Measured by the Number of Dose Limiting Toxicities Seen in Cohort.|"Only dose limiting toxicities (DLT) were collected. DLTs were graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~The occurrence of any of the following toxicities during the first treatment cycle constitutes DLT in this study:~Grade 3 and/or 4 non-hematologic toxicity other than grade 3 nausea or vomiting.~Grade 3 and/or 4 unexpected non-hematologic toxicities. Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and fever during first cycle. Grade 4 neutropenia on Day 1 of 2nd treatment cycle despite growth factor support or grade 4 thrombocytopenia on Day 1 of 2nd treatment cycle."|From the day that the first treatment is given through the first 28 day period for each patient.|Patients that experienced a DLT in the first cycle in each cohort. If one DLT is seen in the first 3 patients then 3 more patients are enrolled in that cohort. MTD and is defined as the lowest dose level at which two or more patients experience a DLT. The study closed before enough patients were enrolled to determine the MTD or define DLTs.|||DLT|||Number
2822022|NCT00369590|Secondary|Overall Survival|all patients alive as of the last contact were censored for survival on the basis of that contact date|3 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis|||weeks||Full Range|Median
2822023|NCT00369590|Secondary|Progression Free Survival (PFS) Rate for Subjects With Radiographic Response|"pts with confirmed radiographic response and their rate of progression (PFS).~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|up to 3 years|"Arm1 had total of 7 pts with response however, 2 pts stopped treatment early and were censored at 6 and 10 weeks.~Arm 2 had total to 7 pts with response however 1 pt stopped treatment after 2 weeks but had a 4 week scan showing PR. - pt was censored."|||weeks||95% Confidence Interval|Median
2822024|NCT00369590|Primary|Safety Profile - Events That Discontinued Treatment|number of patients who experienced toxicity that led to being taken off treatment|Approximately 1 year (start of treatment - end of treatment)||||participants|||Number
2822025|NCT00369590|Primary|Safety Profile - Toxicities|number of cycles patient was able to have before developing a toxicity that required removing the patient from treatment. Treatment: Aflibercept 4mg/kg intravenously on day 1 of every 14-day cycle - 2 week cycle.|Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks)||||cycles||Full Range|Median
2822026|NCT00369590|Secondary|Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response|"pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. All responders were centrally reviewed for confirmation~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|Up to 2 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis|||participants|||Number
2822027|NCT00369590|Primary|Progression-free Survival (PFS) at 6 Months|"This design yields 85% power to detect a true 30% 6-month PFS rate, while maintaining .91 probability of rejecting for a true 15% 6-month PFS rate.~pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression.~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|6 months|"pts not known to be progression free at time of the 6-month scan (24weeks) were considered to experienced treatment failure. If at least 10pts (24%) are progression-frree at 6months (GBM) the agent will be considered promising for futher study.~The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis"|||percentage of participants|||Number
2822028|NCT00369577|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|2 hours|All patients treated|||Participants|||Count of Participants
2822029|NCT00369577|Secondary|Clinical Global Impressions-Improvement Scale (CGI-I) After Drug Administration|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|2 hours|All patients receiving treatment|||CGI-I Units (7=worse, 1=better)||Standard Deviation|Mean
2822030|NCT00369577|Secondary|BARS Change From Baseline After Drug Treatment|Change from baseline on the Behavioral Activity Rating Scale (BARS) ranging from 1 to 7 where: 1 = difficult or unable to rouse, 2 = asleep but responds normally to verbal or physical contact, 3 = drowsy, appears sedated, 4 = quiet, and awake (normal level of activity), 5 = signs of overt (physical or verbal) activity, calms down with instructions, 6 = extremely or continuously active, not requiring restraint, 7 = violent, requires restraint.|2 hours|All patients receiving experimental treatment|||BARS Score, Change from Baseline, units||Standard Deviation|Mean
2822031|NCT00369577|Primary|PANSS-EC Change From Baseline|The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|2 hours|The ITT population consisted of all patients who took any study medication and had both baseline data and at least 1 efficacy assessment after the. Any observation recorded after the use of rescue medication was censored and subject to the last observation carried forward algorithm.|||PANSS units||Standard Deviation|Mean
2822032|NCT00369564|Secondary|Ability to Receive All Scheduled Doses of Vincristine|We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group|10 weeks|||||||
2822033|NCT00369564|Secondary|Frequency and Types of Neurotoxicity Observed|Frequency and types of neurotoxicity observed among those children treated with l-glutamic acid hydrochloride as compared to those who are in the placebo control group|10 weeks|||||||
2822034|NCT00369564|Primary|Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)|"A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified Balis Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportion experiencing a grade 2 or higher toxicity from the following list of neurologic toxicities captured on the Neurologic Exam Form including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, or other specified abnormalities noted by the attending physician. Percentage of patients with one or more Grade 2 or higher noted neurotoxicity symptoms on any item in the Balis scale will compared between arms."|10 weeks|Patients reporting baseline and post-baseline observation|||percentage of participants||95% Confidence Interval|Number
2822035|NCT00369512|Primary|Number of Patients With Recurrence at 2 Years|Rate of recurrence at 2 years.|2 years||||participants|||Number
2822036|NCT00369512|Primary|Median Time to Cancer Recurrence|Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.|2 years||||months||Full Range|Median
2822037|NCT00369512|Primary|Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.|Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events|2 years||||number of adverse events|||Number
2822038|NCT00369486|Secondary|Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks|Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit|||eyes|||Number
2822039|NCT00369486|Secondary|Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks|Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit|||eyes|Participants||Number
2822040|NCT00369486|Primary|Mean Visual Acuity Letter Score at Each Follow-up Visit|Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.|||letter score|Participants|Standard Deviation|Mean
2822087|NCT00369278|Secondary|Number of Participants With Single Treatment Failures|"Rates for all individual components of the primary endpoint 'treatment failure' until day 180:~Acute rejection diagnosed by biopsy (BPAR)~graft loss~death~loss to follow up~discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity)~conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)"|6 months|Intent-to-treat population|||Participants|||Number
2822041|NCT00369486|Primary|Change in Visual Acuity Letter Score From Baseline Through 34 Weeks|Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.|||letter score|Participants|Standard Deviation|Mean
2822042|NCT00369486|Secondary|Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks|Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment.|17 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit|||eyes|Participants||Number
2822043|NCT00369486|Primary|Change in Central Subfield Thickening From Baseline Through 34 Weeks|Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.|4, 8, 17, 34 weeks|Last Observation Carried Forward was used. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.|||microns|Participants|Standard Deviation|Mean
2822044|NCT00369382|Secondary|Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy||Baseline up to Week 52|Safety population.|||Participants|||Number
2822045|NCT00369382|Secondary|Number of Participants Requiring Antibody Use in Treatment of Acute Rejection|Number of participants requiring antilymphocyte antibody therapy with suspected or biopsy-proven, steroid-resistant, acute rejection with or without hemodynamic compromise. Acute rejection based on ISHLT 1990 criteria: all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; N=participants who had biopsy-confirmed acute rejection.|||Participants|||Number
2822046|NCT00369382|Secondary|Time to First Acute Rejection|Time from baseline to first biopsy-confirmed acute rejection defined as any of the following (based on ISHLT 1990 criteria): all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; not analyzed because actual start date of rejection was unknown for those diagnosed by site protocol (SOC) biopsy and protocol-required biopsy.|||Weeks|||Number
2822047|NCT00369382|Secondary|Number of Participants With Biopsy-confirmed Acute Rejection by Severity|Severity of acute rejection summarized using revised 2005 ISHLT criteria. Grade 0R: no rejection, Grade 1R: Focal (perivascular or interstitial) infiltrate without necrosis, diffuse but sparse infiltrate without necrosis, or one focus only with aggressive infiltration and/or focal myocyte damage, Grade 2R:Multifocal aggressive infiltrates and/or myocyte damage, and Grade 3R:Diffuse inflammatory process with necrosis, or diffuse aggressive polymorphous with necrosis, increased infiltrate, changes in edema, hemorrhage and vasculitis.|Baseline to Week 52|Safety population|||Participants|||Number
2822048|NCT00369382|Secondary|Number of Participants With Acute Rejection|Based on International Society for Heart and Lung Transplantation [ISHLT] 1990 criteria: rejections Grade 3A or higher, rejection accompanied by hemodynamic compromise or requiring treatment. Grade 3A or higher included: multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis. Biopsies performed for clinically suspected rejection (for cause), site's standard of care (site protocol biopsy), or protocol mandated.|Baseline to Week 52|Safety population; n=number of participants analyzed for the specified type of biopsy.|||Participants|||Number
2822049|NCT00369382|Secondary|Overall Survival (OS)|Survival time from the start of study treatment to date of death due to any cause, censored at the last visit if no death. Death was determined from the Death report. The distribution of time to death was to be estimated using Kaplan-Meier method and compared between treatment groups with a proportional hazard model. The number and percent of survival at 6 and 12 months were to be reported.|Baseline until death (up to Week 56)|Safety population: all randomized participants who received at least 1 dose of study medication; not analyzed by Kaplan-Meier because number of events limited to 2 deaths in the sirolimus group.|||Weeks|||Number
2822050|NCT00369382|Secondary|Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)|The change in creatinine clearance over time assessed using the random coefficient slope of the regression line with creatinine clearance as the dependent variable and study day as the independent variable. Time points calculated as study days, relative to time of randomization of study medication. Observed data multiplied by a scale factor of 365 to express an annual change.|Baseline to discontinuation (up to Week 52)|ITT; N=participants with all measurements required for calculated creatinine clearance. All observed data up to the point of discontinuation of the study were used.|||mL/min/1.73m^2||95% Confidence Interval|Number
2822051|NCT00369382|Secondary|Serum Creatinine Level at Baseline|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.|Baseline|ITT.|||mcmol/L||Standard Deviation|Mean
2822052|NCT00369382|Secondary|Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week x minus baseline level where higher scores represented decreased kidney function. Least squares mean adjusted for treatment group and center.|Baseline and Weeks 4, 16, 24, 32, 40, and 52|ITT, All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.|||mcmol/L||Standard Error|Least Squares Mean
2822053|NCT00369382|Secondary|Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline|Creatinine clearance calculated using MDRD equation. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT.|||mL/min/1.73m^2||Standard Deviation|Mean
2822054|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization|Creatinine clearance calculated using MDRD equation. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. Least squares mean adjusted for baseline calculated creatinine clearance (MDRD) and center.|Baseline and Weeks 4, 16, 24, 32, 40 and 52|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2822055|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Weeks 4, 16, 24, 32, and 40|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study; N=participants with all measurements required for calculated creatinine clearance.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2822056|NCT00369382|Primary|Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline|Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT; N=participants with all measurements required for calculated creatinine clearance.|||mL/min/1.73m^2||Standard Deviation|Mean
2822057|NCT00369382|Primary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Week 52|Intent-to-Treat (ITT) Population: all randomized participants; all available data (on-therapy and off-therapy) included; Last observation carried forward (LOCF) for data missing due to skipped visits or participant withdrawal from study. Number of participants analyzed (N)=those with all measurements required for calculated creatinine clearance.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2822058|NCT00369343|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|6 months|Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with <4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)|||units on scale||Standard Deviation|Mean
2822059|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||units on scale||Standard Deviation|Mean
2822060|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||units on scale||Standard Deviation|Mean
2822061|NCT00369343|Secondary|Percentage of Patients Achieving a Response to Treatment|A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||percentage of patients responding|||Number
2822062|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||percentage of patients|||Number
2822063|NCT00369343|Secondary|Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.|||units on scale||Standard Deviation|Mean
2822064|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.|open label baseline and 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.|||units on scale||Standard Deviation|Mean
2822065|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.|||units on scale||Standard Error|Mean
2822066|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.|||units on scale||Standard Error|Mean
2822067|NCT00369343|Secondary|Percentage of Patients Achieving Response to Treatment|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).|||percentage of patients|||Number
2822068|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).|||percentage of patients|||Number
2822069|NCT00369343|Secondary|Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).|||percentage of patients|||Number
2822083|NCT00369278|Primary|Number of Participants With Any Treatment Failure|Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.|6 months||||Participants|||Number
2822070|NCT00369343|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.|||units on scale||Standard Error|Mean
2822071|NCT00369317|Secondary|Gene Expression Profiles by Microarrays|A hierarchical clustering algorithm is used to assemble the genes into a dendrogram or tree structure with branches containing genes with similar patterns of expression. This ordered representation can be graphically displayed with colors that reflect the qualitative and quantitative relationships of the expressed genes.|At baseline and at the time of relapse (if available)|The Microarray analysis secondary outcome is not available because the number of specimens with good quality wasn’t sufficient to yield meaningful results.||||||
2822072|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of half-life of elimination. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data for half-life of elimination (n=146) are excluded.|||Mean minutes||Standard Deviation|Mean
2822073|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of area under the concentration time curve. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data for area under the concentration time curve (n=146) are excluded.|||Mean micromolar x minutes||Standard Deviation|Mean
2822074|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program|Mean and standard deviation of peak plasma concentration. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only.|Days 1, 2, 8, and 9 of induction II|Ineligible patients (n=1) are excluded. Patients without available data from peak plasma concentration (n=146) are excluded.|||Mean micromolar||Standard Deviation|Mean
2822075|NCT00369317|Secondary|Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry|Proportion of participants in complete remission by morphology and with positive MRD by flow cytometry among patients having evaluable remission and MRD assessment.|After Induction I therapy (day 28 from start of therapy)|Ineligible patients (n=1) are excluded. Patients without available MRD at end of Induction I (n=58) or not evaluable for morphologic remission assessment (n=7) are excluded. MRD data are not available at end of Induction IV or after completion of Intensification therapy.|||Proportion of participants|||Number
2822076|NCT00369317|Secondary|Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis|Proportion of participants having GATA1 mutation among patients with phenotype data available.|At baseline and at the end of therapy (intensification) or disease relapse|Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=158). Data are not available at end of therapy or relapse.|||Proportion of participants|||Number
2822077|NCT00369317|Secondary|Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry|Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available.|At the start of therapy|Ineligible patients (n=1) are excluded. Patients without available or evaluable phenotype data are excluded (n=40). Data are not available at end of therapy or relapse.|||Proportion of participants|||Number
2822078|NCT00369317|Secondary|Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Proportion of participants with at least one grade 3 or higher adverse event during therapy.|From the beginning of induction therapy to the end of intensification therapy|Ineligible patients (n=1) are excluded.|||Proportion of participants|||Number
2822079|NCT00369317|Secondary|Induction Remission Rate|Proportion of participants with a remission after four courses of Induction therapy.|End of induction therapy (day 112)|Ineligible (n=1) patients are excluded. Patients who withdrew from therapy before completing 4 courses of Induction and did not die or relapse are not evaluable (n=9) for Induction remission rate.|||Proportion of participants|||Number
2822080|NCT00369317|Primary|Overall Survival (OS) at 3 Years||Time from study entry to death, assessed at 3 years.|Ineligible patients are excluded from analyses of overall survival and event free survival.|||percentage||95% Confidence Interval|Number
2822081|NCT00369317|Primary|Event-free Survival (EFS) at 3 Years||Time from study entry to induction failure, relapse, or death assessed at 3 years.|Ineligible patients are excluded from analyses of event free survival and overall survival.|||percentage||95% Confidence Interval|Number
2822082|NCT00369278|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR)|"The Glomerular Filtration Rate (GFR) was calculated using the following formulas:~Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels.~MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels."|6 months|Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).|||ml/min||Standard Deviation|Mean
2822084|NCT00369278|Secondary|Renal Function as Measured by Serum Creatinine||6 months||||mg/dL||Standard Deviation|Mean
2822089|NCT00369278|Primary|Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L|Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.|Assessed on day 3, 10, 21, 42, 56 and 84|Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.|||Days||95% Confidence Interval|Median
2822090|NCT00369265|Primary|Percentage of Participants With Improvement or Resolution of Arytenoid Erythema|Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks|6 weeks|No results to report; Study was terminated||||||
2822091|NCT00369226|Secondary|Overall Survival and Progression-free Survival.|Progression is defined as disease relapse or disease progression since transplant.|by 1 year after PBSC infusion||||percentage of participants||95% Confidence Interval|Number
2822092|NCT00369226|Secondary|Incidence of Chronic Graft Versus Host Disease (Chronic GVHD).|Number of participants with chronic GVHD at 1 year post transplant.|by 1 year after PBSC infusion||||percentage of participants||95% Confidence Interval|Number
2822093|NCT00369226|Secondary|Sustained Engraftment Following Transplant.|As measured by median total donor chimerism at day 100.|by day 100 post transplant|Several subjects experienced failure to graft, relapse or death prior to assessment and were removed from analysis.|||percentage of participants|||Number
2822094|NCT00369226|Primary|Incidence of Grade II-IV Acute Graft Versus Host Disease (GVHD) by Day 100.||by day 100 after peripheral blood stem cell (PBSC) infusion||||percentage of participants||95% Confidence Interval|Number
2822095|NCT00369226|Primary|Successful Initial Engraftment by Day 45 Post Peripheral Blood Stem Cell (PBSC) Infusion and Administration of Bortezomib (Velcade), Tacrolimus and Methotrexate|Percentage of participants who did not experience failure to engraft or relapse or death before assessment.|by day 45 post PBSC infusion||||percentage of participants|||Number
2822096|NCT00369226|Primary|The Maximally Tolerated Dose (MTD) of Bortezomib (Velcade) That Can be Administered With Tacrolimus and Methotrexate After Mismatched Allogeneic Non-myeloablative Peripheral Blood Stem Cell (PBSC) Transplantation|"The MTD of bortezomib was evaluated at 3 dose levels:~Dose level 1: 1.0 mg/m^2 Dose level 2: 1.3 mg/m^2 Dose level 3: 1.5 mg/m^2 Cohorts of 3-5 pts were enrolled at each dose level. At any dose level, if no DLT in the first 3, 4, or 5 pts, then dose escalation would occur.~If 3 evaluable pts in cohort, and 1 of 3 experiences DLT then 2 additional pts treated at the same dose level. If >=1 of 2 additional pts experience DLT then previous dose level will be MTD. If no DLT in additional 2 pts then dose escalation will occur. If 4 evaluable pts in cohort, and 1 of the 4 experiences DLT then 1 additional pt treated at same dose level. If this additional pt experiences DLT then the previous dose will be declared to be the MTD. If additional pt does not experience DLT, then dose escalation will take place. If 5 evaluable pts in cohort, and 1 experiences DLT, then dose escalation will take place. If >=2 of first 3, 4, or 5 pts experience DLT then the previous dose will be declared MTD."|by day 45 post PBSC infusion||||mg/m^2|||Number
2822097|NCT00369161|Secondary|Percentage of Participants With Efficacy Failure|Efficacy failure was a composite of BPAR, graft loss, death or lost to follow-up. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy. An allograft was presumed to be lost on the day a patient started dialysis and was unable to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss.|Month 12|Intention to treat (ITT) population.|||percentage of participants|||Number
2822098|NCT00369161|Secondary|Number of Participants With Incidence of Biopsy-proven Acute Rejection (BPAR)|Biopsy-proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy.|from Month 4 through to Month 12|Intention to treat (ITT) population.|||participants|||Number
2822099|NCT00369161|Primary|Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)|"Renal function was assessed by calculated glomerular filtration rate (cGFR) using Modification of Diet in Renal Disease (MDRD)formula.~GFR [mL/min/1.73m^2] = 186.3*(C-1.154)*(A-0.203)*G*R, where:~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|12 months post -transplant|Modified Intent-to-treat (ITT) population i.e patients with an available cGFR at month 12.|||mL/min/1.73m^2||Standard Deviation|Mean
2822100|NCT00369122|Secondary|Overall Survival (Three-year Rate Reported)|Overall survival time is defined as time from registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 3 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2822101|NCT00369122|Secondary|Disease-free Survival (Three-year Rate Reported)|Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.|From registration to 3 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2822112|NCT00368979|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52|The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||score on a scale||Standard Deviation|Mean
2822332|NCT00366457|Secondary|Toxicity Profile|Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening|during and after first 28-day cycle of treatment|participants who started treatment|||Participants|||Count of Participants
2822102|NCT00369122|Secondary|Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.|Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.|From start of treatment to last follow-up, up to 6.0 years. Analysis occurred after all patients had been on study for at least 2 years.|Eligible patients who started study treatment|||participants|||Number
2822103|NCT00369122|Primary|Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.|Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.|From start of treatment to 90 days.|Eligible patients who began study treatment.|||participants|||Number
2822104|NCT00368992|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a >= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.|Every 6 weeks while on protocol treatment, up to 3 years.|Eligible patients who received protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2822105|NCT00368992|Secondary|Overall Survival|From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.|Once a week, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.|||months||95% Confidence Interval|Median
2822106|NCT00368992|Secondary|Progression-Free Survival|From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.|||Months||95% Confidence Interval|Median
2822107|NCT00368992|Primary|The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.|All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.|Every week until removed from protocol therapy, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2822108|NCT00368979|Secondary|Number of Participants With Qmax Improvement From Baseline at Week 52|Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||participants|||Number
2822109|NCT00368979|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52|Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||milliliters per second (mL/sec)||Standard Deviation|Mean
2822110|NCT00368979|Secondary|Number of Participants With IPSS Improvement From Baseline at Week 52|Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||participants|||Number
2822111|NCT00368979|Secondary|Percent Change From Baseline in Prostate Volume at Week 52|Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.|||cubic centimeters (cc)||Standard Deviation|Mean
2822854|NCT00362297|Secondary|Frequency of Subclinical Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks|||||||
2822113|NCT00368966|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
2822114|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
2822115|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2822116|NCT00368966|Primary|Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2822117|NCT00368966|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2822118|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2822119|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2822120|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2822121|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2822122|NCT00368966|Primary|Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2822123|NCT00368966|Primary|Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series|Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.|One month after 2-doses of the infant series (5 months of age)|Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
2822124|NCT00368940|Secondary|Sheehan Disability Scale.|Sheehan Disability Scale is a measure of disability. Range of scores: 0-20. Higher scores reflect worse outcome (disability).|Outcome at 12 weeks||||units on a scale||Standard Deviation|Mean
2822125|NCT00368940|Secondary|Hamilton Depression Rating Scale|Hamilton Depression Rating Scale is a scale measuring depression severity. Range of scores: 1-33. Higher scores reflect worse outcome (depression).|Outcome at 12 weeks||||units on a scale||Standard Deviation|Mean
2822126|NCT00368940|Primary|WHO Disability Assessment Schedule (WHODAS)-II|WHO Disability Assessment Schedule (WHODAS)-II is a disability scale. Range of scores: 12-43. Higher scores represent worse outcome (disability).|12-week outcome||||WHODAS-II units||Standard Error|Least Squares Mean
2822127|NCT00368940|Primary|Montgomery Asberg Depression Scale (MADRS)|Montgomery Asberg Depression Scale (MADRS) is a depression rating scale. Range of scores (1-35). Higher scores represent worse outcome (depression).|12 week outcome||||Units on MADRS scale||Standard Error|Least Squares Mean
2822128|NCT00368927|Secondary|Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention|The number of dysplastic lesions was recorded pre-intervention and post-intervention for each participant in each group. Change in the number of lesions was compared between the two intervention groups.|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post- intervention bronchoscopy.|||Percent change in number of DL||Full Range|Median
2822129|NCT00368927|Primary|Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment|Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
2822130|NCT00368875|Secondary|Overall Survival(OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|Time from first treatment day until death, assessed up to 12 months|54 patients in the phase I and phase II portion were evaluated|||months||95% Confidence Interval|Median
2822131|NCT00368875|Secondary|Time to Treatment Failure (TTF)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae. Time to treatment failure was not reported for this study.|Time from the first treatment day until disease progression or discontinuation of treatment due to toxicity, assessed up to 12 months|Zero participants analyzed because time to treatment failure was not assessed.||||||
2822132|NCT00368875|Secondary|Progression-free Survival (PFS),|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until objective or symptomatic progression, assessed up to 12 months|53 patients in the phase I and phase II portions were evaluated|||months||95% Confidence Interval|Median
2822133|NCT00368875|Primary|Objective Response Rate (CR + PR)|Estimated and a 95% confidence interval will be estimated via binomial proportions. Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions and assessed by CT scan: Complete response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 12 months|53 patients in the phase I and phase II portions were evaluated. One patient was not eligible to be evaluated for objective response rate.|||percentage of participants||95% Confidence Interval|Number
2822134|NCT00368875|Primary|Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT|28 days|Three patients were treated at the first vorinostat dose level of 200 mg BID and three additional patients were treated at the second dose level of 300 mg BID|||mg|||Number
2822135|NCT00368849|Secondary|Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score|Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||units on a scale||Standard Error|Mean
2822136|NCT00368849|Secondary|Symptom Checklist-90-Revised (SCL-90-R)|Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||units on a scale||Standard Error|Mean
2822137|NCT00368849|Primary|Executive Composite Score|The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||units on a scale||Standard Error|Mean
2822138|NCT00368849|Primary|Attention Composite Score|The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.|||Units on a scale||Standard Error|Mean
2822139|NCT00368849|Primary|Conners' Adult Attention Rating Scale (CAARS)|The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers|||units on a scale||Standard Error|Mean
2822140|NCT00368745|Secondary|Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6)|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine toxicology assay (each visit Alprazolam Free phase), negative urine alcohol assay (Alprazolam Free Week 6 = endpoint or LOCF). Relapse: > = 2 intakes rescue medication, positive urine and /or alcohol assays, unable to tolerate alprazolam taper, or discontinuation.|Alprazolam Free Week 6|ITT; endpoint = AF Week 6 or LOCF.|||participants|||Number
2822141|NCT00368745|Secondary|Time to First Use of Rescue Medication|The 25th percentile estimate of time until first use of rescue medication is based on Kaplan-Meier estimates. Event day is the study day when the subject first used rescue medication. Rescue medication: packet with 2 doses alprazolam to take only in the event subject experiences severe symptoms of benzodiazepine withdrawal or rebound anxiety.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF|||days|||Number
2822142|NCT00368745|Secondary|Time to Discontinuation|The 25th percentile estimate of time until discontinuation is based on Kaplan-Meier estimates. Event day is the study day when the subject discontinued from study.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF.|||days|||Number
2822143|NCT00368745|Secondary|Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores|DSST: subject-rated; evaluates aspects of cognition (includes attending to directions, processing speed, sustained attention, visual-motor integration, learning and psychomotor speed). Subject matches symbol (1 to 9) with corresponding number key (1 to 9); number of correct symbol-number pairs completed by subject over a 90-second test period determines DSST score. Change: mean at observation minus mean at baseline. Data summarized as change from baseline to endpoint.|Baseline, Endpoint (AF Week 6 )|ITT; subject has baseline and endpoint (final visit) measurement; endpoint = AF Week 6 or LOCF.|||scores on scale||Standard Error|Least Squares Mean
2822144|NCT00368745|Secondary|Mean Scores for Patient Global Impression-Improvement (PGI-I)|PGI-I: subject rated 7-point scale measures change in overall status; range 1 (very much improved) to 7 (very much worse).|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2822145|NCT00368745|Secondary|Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I: 7-point scale to assess global change in subject condition compared to baseline; range 1 (very much improved) to 7 (very much worse); higher score = more affected.|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2822146|NCT00368745|Secondary|Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores.|CGI-S: 7-point scale to assess global change in subject condition compared to baseline; range 1 (no evidence of illness) to 7 (among the most severely ill); higher score = more affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and at least 1 post-baseline endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2822147|NCT00368745|Secondary|Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.|||scores on scale||Standard Deviation|Mean
2822172|NCT00368459|Secondary|Cognitive (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 12 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
2822173|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
2822148|NCT00368745|Post-Hoc|Mean Scores Physician's Withdrawal Checklist (PWC)|Mean scores at each visit for PWC: 20-item physician-rated interview measures presence of anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception, and cognition); range 0 (not present) to 3 (severe). Total score: 0 to 60; higher score = more affected. Mean scores entered as post-hoc analysis as Mean change from baseline in PWS scores not analyzed: PWS not measured at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 )|ITT; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. Endpoint = AF Week 6 or LOCF. Refer to measure Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores.|||scores on scale||Standard Error|Least Squares Mean
2822149|NCT00368745|Secondary|Number of Subjects With > = 5 New PWC Symptoms|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.|||particpants|||Number
2822150|NCT00368745|Secondary|Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.|||particpants|||Number
2822151|NCT00368745|Secondary|Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); lower score indicates less affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6)|ITT; subject has a baseline and at least 1 post-baseline measurement before week 13; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2822152|NCT00368745|Primary|Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine benzodiazepine psychoactive toxicology assay (each visit Alprazolam Free phase); negative serum benzodiazepine alcohol assay (endpoint or LOCF).|Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)|Intent to Treat (ITT) population: received at least 1 dose pregabalin or placebo. Primary outcome ITT = all treated subjects in alprazolam free phase. Endpoint = Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1.|||participants|||Number
2822153|NCT00368654|Secondary|Adverse Events (AE)|measured by whether or not AE was serious|16 vs. 36 weeks, depending on study arm|Data not collected||||||
2822154|NCT00368654|Primary|PASI -- Psoriasis Area and Severity Index|(PASI) - given by numerical score, the index shows the severity of psoriasis.|16 vs. 36 weeks, depending on study arm|data not collected||||||
2822155|NCT00368641|Primary|All-cause Hospitalization (Unadjusted)|All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.|6 to 24 months|intent to treat population|||hospitalizations per year||95% Confidence Interval|Mean
2822156|NCT00368550|Secondary|Change in the Level of Alcohol-related Problems|Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.|12-week treatment period compared with baseline value||||Units on a scale||Standard Deviation|Mean
2822157|NCT00368550|Secondary|Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.|12-week treatment period||||days||Standard Deviation|Mean
2822158|NCT00368550|Primary|Number of Days on Which Subjects Drank|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.|12-week treatment period|All randomized subjects with missing days imputed as drinking days.|||days||Standard Deviation|Mean
2822159|NCT00368537|Secondary|Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients|Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study article.|||participants|||Number
2822160|NCT00368537|Secondary|Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate|In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|"m-mITT: Patients with ≥1 dose of study drug, had cSSSI and baseline isolate from infection site / blood. MIC reported for isolates present in ≥10 m-mITT patients. In the categories below n is the actual number of isolates used to caluculate the MIC 50 and MIC 90."|||mcg/mL|||Number
2822161|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|up to 6 weeks|Microbiologically Evaluable patients:CE patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). TOC performed 8-50 days after last dose of study drug.|||participants|||Number
2822162|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|Microbiologically Evaluable patients:Clinically Evaluable (CE) patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). Excludes indeterminates.|||participants|||Number
2822163|NCT00368537|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.|up to 6 weeks|Clinically Evaluable (CE): Patients with cSSSI, no Pseudomonas aeruginosa as sole baseline isolate, met major inclusion/exclusion criteria, ≤24 hrs antibiotics pre-baseline, had ≥4 days of study drug, compliant with therapy. Excludes indeterminates.|||participants|||Number
2822164|NCT00368472|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.|Baseline up to week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.|||Percent responders|||Number
2822165|NCT00368472|Secondary|Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.|Baseline up to Week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.|||Percent Change||Full Range|Median
2822166|NCT00368472|Primary|Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years|Safety Analysis Set was defined as participants who received at least 1 dose of open-label perampanel and had at least 1 safety assessment after the first dose of perampanel in the OLE study.|||Participants|||Number
2822167|NCT00368459|Secondary|Cognition (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 6 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
2822168|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
2822169|NCT00368459|Secondary|Function, Activities of Daily Living|Change from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
2822170|NCT00368459|Secondary|Clinical Dementia Rating, Sum of Boxes|Change from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
2822171|NCT00368459|Secondary|ADAS-cog|Change from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.|6 months||||units on a scale||Standard Deviation|Mean
2822174|NCT00368459|Secondary|Function, Activities of Daily Living (ADL)|ADL scale from the Alzheimer's Disease Cooperative Study, change from baseline at 12 months. Range 0-78. For results below, positive change represents improvement/ better performance.|12 months||||units on a scale||Standard Deviation|Mean
2822176|NCT00368459|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)|"ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance.~For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values."|12 months|Intent-to-treat|||units on a scale||Standard Deviation|Mean
2822177|NCT00368355|Other Pre-specified|Length of Remission in Patients|Median length of remission in patients with high risk leukemia treated with myeloablative chemotherapy, radiotherapy and CD34 selected peripheral blood stem cells from haploidentical related donors using Kaplan-Meier method|1 Year|||||||
2822178|NCT00368355|Other Pre-specified|Immune Reconstitution|To evaluate the effect of T-cell depletion by positive selection for CD34 on immune reconstitution, which will be determined from total lymphocyte count, from T and B cell numbers and from T cell subset analyses.|1 Year|||||||
2822179|NCT00368355|Secondary|Patients With Chronic GVHD|Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.|Up to 1 Year|Patients surviving more than 100 days were evaluable for chronic GvHD. Of the 46 participants at baseline, eight participants in CLINIMACS and six in ISOLEX were not evaluable for chronic GVHD and were not included in this analysis.|||Participants|||Count of Participants
2822180|NCT00368355|Secondary|Patients With Acute GVHD|Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD|First 100 Days|A participant is evaluable for acute GVHD if the participant engrafted and either completed 100 days observation after transplant or experienced acute GVHD. Of the 46 participants at baseline, eight participants in CLINIMACS and five in ISOLEX were not evaluable for acute GVHD and were not included in this analysis.|||Participants|||Count of Participants
2822181|NCT00368355|Secondary|Severe GVHD Rate|Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.|100 Days|A participant is evaluable for acute GVHD if the participant engrafted and either completed 100 days observation after transplant or experienced acute GVHD. Of the 46 participants at baseline, eight participants in CLINIMACS and five in ISOLEX were not evaluable for acute GVHD and were not included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2822182|NCT00368355|Secondary|Early Post BMT Toxicities|Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)|100 Days|Of the 46 participants at baseline, one participant in CLINIMACS Device group did not undergo haploidentical stem cell transplant and was not included in this analysis.|||Participants|||Count of Participants
2822183|NCT00368355|Primary|Engraftment Rate After Transplant|Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10^9/ml.|28 days|A participant is evaluable for engraftment if the participant underwent transplant and either completed 28 days observation or engrafted. Of the 46 participants at baseline, one in CLINIMACS group did not undergo transplant and one in ISOLEX group died 5 days after transplant.Thus, 2 participants were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2822184|NCT00368316|Secondary|Percentage of Efficacy|Percent efficacy is defined as ((disease rate of controls minus disease rate of vaccinees) divided by disease rate of controls) times 100|During 2 years post vaccination||||Percent efficacy||95% Confidence Interval|Mean
2822185|NCT00368316|Secondary|Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels|Age-related homologous IgG anti-LPS levels|Injections were administered 6 weeks apart and IgG anti-LPS levels determined >2 weeks after second vaccine dose. Each of the 15 sites also took a sample/week randomly chosen, for 2 years of follow up and blood samples from patients with disease||||ELISA units||95% Confidence Interval|Geometric Mean
2822186|NCT00368316|Primary|Number of Participants With Adverse Events|Number of participants with events per vaccine type and dose occuring in >=5% of participants|Monitored for 7 days per participant following each injection for initial group of 500, 2 days for extended study of up to 5500 additional children||||participants|||Number
2822187|NCT00368290|Primary|Cocaine Use as Measured by Urine Drug Screen|The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.|8 weeks||||Percentage of Participants|||Number
2822188|NCT00368290|Primary|Percent of Participants Reporting no Cocaine Craving|Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.|8 weeks||||Percent of participants|||Number
2822189|NCT00368277|Secondary|Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36||Baseline and week 36|Intent to treat (ITT), Last Observation Carried forward (LOCF)|||mm Hg||Standard Error|Least Squares Mean
2822190|NCT00368277|Secondary|Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints|Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg|Weeks 12 and 36|intent to treat (ITT), last observation carried forward (LOCF)|||Percentage of participants|||Number
2822191|NCT00368277|Secondary|Percentage of Patients With Cough||Weeks 12 and 36|Safety population|||Percentage of Participants|||Number
2822192|NCT00368277|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12||Baseline and Week 12|Intent to treat (ITT), Last Observation Carried forward (LOCF)|||mm Hg||Standard Error|Least Squares Mean
2822193|NCT00368251|Secondary|Global Evaluation Score (Investigator) at the End of Treatment Period|The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).|End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.|||percentage of participants|||Number
2822194|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)|The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.|||Percent change||Full Range|Median
2822195|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)|The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.|||Percent change||Full Range|Median
2822196|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)|The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.|||Percent change||Full Range|Median
2822197|NCT00368251|Primary|Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)|The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.|||Percent change||Full Range|Median
2822198|NCT00368108|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population|||Hours||95% Confidence Interval|Least Squares Mean
2822199|NCT00368108|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
2822200|NCT00368108|Secondary|Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2822201|NCT00368108|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)|"Patients described themselves in home diaries as OFF, ON without dyskinesias, ON with non troublesome dyskinesias, ON with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor."|Baseline and Week 20|The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF).|||Hours||95% Confidence Interval|Least Squares Mean
2822202|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population|Number of POS over the treatment period standardized to 1 week period|Treatment Period (12 weeks)|Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)|||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
2822203|NCT00368069|Secondary|Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks|The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.|over the treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period).|||Participants|||Number
2822204|NCT00368069|Secondary|50% Response in Weekly POS Frequency|A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.|Treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period)|||Participants|||Number
2822205|NCT00368069|Secondary|All (Type I+II+III) Seizures Frequency Per Week|Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)|Treatment period (12 weeks)|ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)|||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
2822206|NCT00368069|Secondary|POS Seizure Frequency Per Week Over Baseline and Treatment Period||Baseline Period (8 weeks) - Treatment Period (12 weeks)|ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for Levetiractam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures|||seizures per week||Inter-Quartile Range|Median
2822207|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population|Number of POS over the treatment period standardized to 1 week period.|Treatment period (12 weeks)|Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)|||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
2822208|NCT00367991|Secondary|Serum Markers of Apoptosis|Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.|Day 1 and Day 10|ITT|||pg/mL||Standard Deviation|Mean
2822209|NCT00367991|Secondary|Circulating Endothelial Progenitor Cells||Day 3 and Day 10|Endothelial progenitor cells could not be isolated and are therefore not reported.||||||
2822210|NCT00367991|Secondary|Serum Markers of Myocyte Damage|Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory.|Baseline|ITT|||U/L||Inter-Quartile Range|Median
2822211|NCT00367991|Secondary|Left Ventricular Ejection Fraction||Day 1 and Day 10|These data were not collected due to lack of funds.||||||
2822212|NCT00367991|Primary|Platelet Function Assay Closure Time||Change from Day 3 to Day 10|ITT|||seconds||Inter-Quartile Range|Median
2822213|NCT00367991|Primary|Bleeding Time|An integrated measure of in vivo platelet function and tissue hemostasis.|Change from Day 3 to Day 10|ITT|||seconds||Inter-Quartile Range|Median
2822214|NCT00367835|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population|||mmHg||Standard Deviation|Mean
2822215|NCT00367835|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population|||mmHg||Standard Deviation|Mean
2822216|NCT00367835|Secondary|Change From Baseline in Pulse Rate at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population|||beats/min||Standard Deviation|Mean
2822217|NCT00367835|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and up to 8 weeks|Safety population defined as all randomized subjects who received at least one dose of any investigational product during this study.|||msec||Standard Deviation|Mean
2822218|NCT00367835|Secondary|Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)|"The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of strongly agree or agree."|up to 8 weeks|FAS|||Participants|||Number
2822219|NCT00367835|Secondary|Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks|The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2822220|NCT00367835|Secondary|Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks|Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.|Baseline and up to 8 weeks|FAS|||units on a scale||Standard Deviation|Mean
2822221|NCT00367835|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS|||Participants|||Number
2822222|NCT00367835|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 8 weeks|FAS|||Participants|||Number
2822223|NCT00367835|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2822224|NCT00367835|Primary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of any investigational product during this study and with a baseline and at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2822225|NCT00367770|Primary|Number of Participants With a Change in WHO Functional Class|"Number of participants with a change in WHO functional class from baseline to week 24.~A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement."|from baseline to week 24|The analysis was done in the safety set.|||participants|||Number
2822226|NCT00367770|Primary|Change in Borg Dyspnea Index|Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.|from baseline to week 24|The analysis was done in the safety set.|||units on a scale||Standard Deviation|Mean
2822227|NCT00367770|Primary|Change in 6-minute Walk Distance||from baseline to week 24|The analysis was done in the safety set.|||m||Standard Deviation|Mean
2822228|NCT00367744|Secondary|the Change in the Carotid IMT of the Common Carotid Artery|Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available|||mm||Inter-Quartile Range|Median
2822229|NCT00367744|Primary|Change in Limb Fat at 48 Weeks|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.|||grams||Inter-Quartile Range|Median
2822230|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins|Baseline and post-therapy plasma samples were obtained from participants. Immunohistochemistry analyses were carried out using a BioPlex 200 machine (Bio-Rad) or by enzyme-linked immunoassays to evaluate levels of angiogenesis-related proteins and other relevant proteins. Post- and pre-treatment changes in cytokines and angiogenic factors in response to pazopanib were analyzed. A negative value indicates that the post-treatment level of the particular target protein was less than the pre-treatment level.|Baseline to at least two weeks and at most 6 weeks|Safety population: all participants who received at least one dose of pazopanib. Only 33 of 35 subjects had plasma samples from both pre- and post-treatment available for analysis.|||ratio||Inter-Quartile Range|Median
2822231|NCT00367679|Secondary|Semiquantitative Levels of Staining in Pre-treatment Tumor Biopsies (e.g. VEGF, VEGFR-1,VEGFR-2).|Analysis not performed as part of study. Appropriate material was not available for analysis.|Entire study interval|Safety Population: all participants who received at least one dose of pazopanib|||Relative luminescence units||Standard Deviation|Mean
2822232|NCT00367679|Secondary|Genetic Variations in Germline DNA|Plasma samples were collected from each consenting participant, generally at baseline, to permit evaluation of the presence or absence of genetic variations in select candidate genes in germline DNA. Analyses that could have been done might have examined the relationship between genetic variants and the safety or tolerability or the efficacy of pazopanib. Analyses have not yet been conducted, but a need to do so may yet be identified. The clinical study report indicated that results, if any, would be reported separately.|Baseline|Safety Population: all participants who received at least one dose of pazopanib|||Sum of changes in gene (DNA) sequences||Standard Deviation|Mean
2822233|NCT00367679|Secondary|Plasma Levels of Lactate Dehydrogenase-5 (LDH5)|LDH5 has been shown to be associated with activation of angiogenesis in lung cancer. Circulating levels of LDH5 were to have been measured at each scheduled visit through the post-treatment visit to determine if a correlation with drug effect existed. Levels of LDH5 were measured, but the team determined that greater value was to be derived from transcriptional and plasma biomarker analyses; thus, no analyses were conducted to examine the correlation of LDH5 levels with effects of pazopanib.|Baseline to at least three weeks and at most 8 weeks|Safety Population: all participants who received at least one dose of pazopanib|||Units/Liter||Standard Deviation|Mean
2822234|NCT00367679|Secondary|Intratumoral Levels of Specific Biomarkers|A pre-treatment tumor biopsy from each participant was to have been analyzed by Western blotting to semi-quantitate levels of various proteins related to angiogenesis and/or to the mechanism of action of pazopanib. These assays were not carried out due to insufficient quantity of tissue present in the pre-treatment biopsy (fine needle aspirate). The clinical study report indicates that results were to have been reported separately.|Baseline tumor biopsy|Safety Population: all participants who received at least one dose of pazopanib|||nanograms/milliliter||Standard Deviation|Mean
2822235|NCT00367679|Secondary|Gene Mutations in Pre- or Post-treatment Tumor Biopsies|Specific genes (KRAS, MYC, TP53, and others) were to have been analyzed for the presence or absence of amplifications or deletions and for the presence, absence, and sequence of point mutations in pre- or post-treatment tumor biopsies. These analyses were not conducted because the potential results were considered to provide overlapping information with those obtained in the transcriptional and proteomic profiling assays that were conducted. The clinical study report indicates that genetic measures were to have been reported separately.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Safety Population: all participants who received at least one dose of pazopanib|||Number of DNA sequence changes||Standard Deviation|Mean
2822236|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes|"Gene expression data analysis was performed with GeneSpring GX 7.3.1 (Agilent Technologies). Data were preprocessed using the RMA algorithm. The Benjamini and Hochberg false discovery rate was used for multiple testing corrections. Data below are log-transformed ratios of the post-treatment to pre-treatment expression intensity, indicating the fold increase/decrease in expression of genes. PDGF, platelet-derived growth factor; VEGFR, vascular endothelial growth factor receptor; c-KIT, a protein tyrosine kinase that is a receptor for stem cell factor or kit ligand."|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tumor tissue from Safety Population: all participants who received at least one dose of pazopanib. Only 26 of 35 subjects had sufficient tissue in both pre- and post-treatment samples for analysis.|||ratio||Standard Deviation|Median
2822237|NCT00367679|Secondary|Number of Cells Exhibiting Apoptosis in Participant Samples|Tumor cells from pre-treatment and post-operative biopsies were to have been analyzed to determine the number of cells that were exhibiting apoptosis. Due to the limited quantity of tissue in pre- and post-treatment biopsy samples, these assays were not performed.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tissue from Safety Population: all participants who received at least one dose of pazopanib|||number of cells||Standard Deviation|Mean
2822238|NCT00367679|Secondary|Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure|Increases in systolic or diastolic blood pressure values at any point in the study following baseline were summarized. mmHg = millimeters of mercury. Baseline blood pressure values as well as the change from baseline experienced are given in the category titles.|Baseline to at least three weeks and at most 8 weeks|Safety Population|||participants|||Number
2822239|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values|Shifts in chemistry values by grade were summarized based on the NIH Common Terminology Criteria for Adverse Events (Version 3.0 - definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here. ULN = upper limit of normal; Gr = grade; mg = milligrams; dL = deciliter; mmol = millimoles.|Baseline to at least three weeks and at most 8 weeks|Safety Population|||participants|||Number
2822240|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values|Shifts in hematology values by grade were summarized based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (Version 3.0 - definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here.|Baseline to at least three weeks and at most 8 weeks|Safety Population|||participants|||Number
2822241|NCT00367679|Secondary|Number of Participants Achieving a >=60% Reduction in Tumor Metabolic Activity Determined as Standard Uptake Value (SUV)|Response is the number of participants whose tumor demonstrated a 60% or greater reduction in metabolic activity (SUV) as measured by positron emission tomography (PET) or PET/computed tomography (PET/CT) at the end of treatment visit relative to baseline. This analysis was not conducted because insufficient data were collected: only three participants had PET/CT data.|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib|||participants|||Number
2822242|NCT00367679|Secondary|Number of Participants Achieving a Clinical Response Based on RECIST|Response is the number of participants achieving either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes not meeting previously given criteria. Confirmation requires at least 2 assessments (conducted by a central reviewer) of CR/PR with at least 4 weeks between the assessments.|Baseline to at least two weeks or at most six weeks|Safety population: all participants who received at least one dose of pazopanib|||participants|||Number
2822243|NCT00367679|Primary|Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume|"Tumor shrinkage was assessed as the change in tumor volume using high-resolution computed tomography scans of the thorax following treatment with pazopanib. Response is defined as the number of participants achieving at least 50% tumor volume reduction following pazopanib treatment. Responder is a participant whose tumor volume reduced at least 50% following pazopanib treatment. Non-responder is a participant whose tumor volume did not reduce at least 50% following treatment. Tumor assessments were conducted by a central reviewer."|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib|||participants|||Number
2822244|NCT00367640|Primary|Average Rhinoconjunctivitis Total Symptom Score|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.~Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 32 days in the ITT set)|The intent-to-treat (ITT) population included all patients who received at least one dose of investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.|||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
2822245|NCT00367601|Secondary|Overall Survival||12 months||||months||95% Confidence Interval|Median
2822246|NCT00367601|Secondary|Time to Progression||12 months||||months||95% Confidence Interval|Median
2822247|NCT00367601|Primary|To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician||4 months||||percentage of participants|||Number
2822248|NCT00367484|Primary|Number of Participants Testing Positive for Neutralising Antibody (NAb)|Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.|48 Weeks|Intent To Treat (ITT) population, Last Observation Carried Forward (LOCF)|||NAb+ participants|||Number
2822249|NCT00367458|Secondary|Change in Percentage of Cluster of Differentiation 8 (CD8+) Human Leukocyte Antigen DR (HLA-DR+), CD8+(CD8+HLADR+CD38+) in Peripheral Blood|CD8+HLADR+CD38+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.|Baseline and 8 weeks||||percent T cell subset||Standard Deviation|Mean
2822250|NCT00367458|Secondary|Change in Percentage of Cluster of Differentiation 8 (CD8+) Human Leukocyte Antigen DR (HLA-DR+) in Peripheral Blood|CD8+HLA-DR+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.|Baseline and 8 weeks||||percent T cell subset||Standard Deviation|Mean
2822251|NCT00367458|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 26 weeks.||||Participants|||Count of Participants
2822252|NCT00367458|Secondary|Change in Percentage of Cluster of Differentiation 4 (CD4+) Human Leukocyte Antigen DR (HLA-DR+) in Peripheral Blood|CD4+HLA-DR+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.|Baseline and 8 weeks||||percent T cell subset||Standard Deviation|Mean
2822253|NCT00367458|Primary|Change in Human Immunodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) Levels|The change in HIV viral RNA level in plasma in response to lipid lowering agents was measured as log10 plasma RNA copy number, and the change in the log10 viral RNA level is included in table.|Baseline and 8 weeks||||Log10 copies/ml plasma||Inter-Quartile Range|Median
2822254|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):~[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Other types of Seizures are all seizures except Partial Seizures (Type 1)."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures.|||Percent Reduction||Inter-Quartile Range|Median
2822255|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):~[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures.|||Percent Reduction||Inter-Quartile Range|Median
2822256|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in secondary generalized seizure frequency is given as a percent reduction computed as:~[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.~Positive values in reduction means the value decreased from Baseline during the first 16-week Period.~Secondary generalized seizures belong to one of the 3 groups:~Simple partial sz evolving to gen sz~Complex partial sz evolving to gen sz~Simple partial sz evolving to Complex partial sz evolving to gen sz"|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures.|||Percent Reduction||Inter-Quartile Range|Median
2822257|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in complex partial seizure frequency is given as a percent reduction computed as:~[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.|||Percent Reduction||Inter-Quartile Range|Median
2822258|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple partial seizure frequency is given as a percent reduction computed as:~[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures.|||Percent Reduction||Inter-Quartile Range|Median
2822259|NCT00367432|Secondary|Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)|"The percent reduction from Baseline was computed as:~[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.~Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).|||Participants|||Number
2822260|NCT00367432|Secondary|Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)|Full Analysis Set (FAS).|||Seizures Per Week||Inter-Quartile Range|Median
2822990|NCT00360724|Other Pre-specified|Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)|To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.|Baseline||||percentage of connecting nods||Standard Deviation|Mean
2822261|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study|"The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:~[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).|||Percent Reduction||Inter-Quartile Range|Median
2822262|NCT00367432|Primary|Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)|"An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.~Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE."|During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted|Safety Set includes all subjects from N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.|||participants|||Number
2822263|NCT00367380|Primary|Infection for P. Vivax|Thick blood smear was performed to patients daily on days 7 to 23, and every other day until day 29. Any prove of P. vivax infection was considered positive and confirmed later by real time polymerase chain reaction (rPCR).|Twenty eight days||||days||Standard Deviation|Mean
2822264|NCT00367341|Secondary|Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks|Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score|Measured at week 12.|completers|||participants|||Number
2822265|NCT00367341|Primary|Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks|# of study participants with Hamilton Depression-17-item score less than or equal to 7.|Measured at week 12|completed study participants in 12-week-trial|||participants|||Number
2822266|NCT00367237|Secondary|Adverse Events|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16|||||||
2822267|NCT00367237|Secondary|Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16|||||||
2822268|NCT00367237|Secondary|Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16|||||||
2822269|NCT00367237|Primary|Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16|>=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.|between baseline and week 16|Number of subjects from Intent-to-Treat population in each arm at Week 16|||participants|||Number
2822270|NCT00367133|Secondary|Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Percentage of Eyes|||Number
2822271|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Microns||Inter-Quartile Range|Median
2822272|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Microns||Standard Deviation|Mean
2822273|NCT00367133|Secondary|Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Microns||Inter-Quartile Range|Median
2822274|NCT00367133|Secondary|Distribution of Visual Acuity Change Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Percentage of Eyes|||Number
2822275|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Letter Score||Inter-Quartile Range|Median
2822276|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.|||Letter Score||Standard Deviation|Mean
2822277|NCT00367133|Secondary|Central Subfield Thickness < 250 Microns at 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.|||Percentage of Eyes|||Number
2822278|NCT00367133|Secondary|Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|Baseline to 2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.|||Percentage of Eyes|||Number
2822279|NCT00367133|Secondary|Median Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 2 Years|Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.|||Microns||Inter-Quartile Range|Median
2822280|NCT00367133|Secondary|Mean Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.|Baseline to 2 years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.|||Microns||Standard Deviation|Mean
2822281|NCT00367133|Primary|Distribution of Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|baseline to 2 years|The primary analysis included all randomized eyes and followed the intent-to-treat principle|||Percentage of Eyes|||Number
2822282|NCT00367133|Primary|Median Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.|||Letter score||Inter-Quartile Range|Median
2822283|NCT00367133|Secondary|Central Subfield Thickness at 2 Years|Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.|||Microns||Inter-Quartile Range|Median
2822284|NCT00367133|Primary|Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.|||Letter score||Standard Deviation|Mean
2822285|NCT00367055|Secondary|Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36|Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration.|Baseline and Months 18 and 36|ITT Population|||micromoles (umol)/kilogram/min/pmol/L||Standard Deviation|Mean
2822286|NCT00367055|Secondary|Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment||Baseline and Month 36|||||||
2822287|NCT00367055|Secondary|Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment||Baseline and Month 36|||||||
2822288|NCT00367055|Secondary|Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment||Baseline and Month 36|||||||
2822289|NCT00367055|Secondary|Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment||Baseline and Month 36|||||||
2822290|NCT00367055|Secondary|Mean Change From Baseline in FBG at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2822291|NCT00367055|Secondary|Mean Change From Baseline in HbA1c at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.|||percent change||Standard Deviation|Mean
2822292|NCT00367055|Secondary|Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment|Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion.|Baseline and Month 18|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."|||pmol/L*min||Full Range|Median
2822293|NCT00367055|Secondary|Median Change From Baseline in the Ratio M/I After a 36-month Treatment||Baseline and Month 36|||||||
2822294|NCT00367055|Primary|Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment|Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).|Baseline and Month 36|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."|||picomoles/L per minute (pmol/L*min)||Full Range|Median
2822295|NCT00366899|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2822296|NCT00366899|Secondary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose|Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2822297|NCT00366899|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2822298|NCT00366899|Primary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|The evaluable pneumococcal immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2822299|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Polio as measured using a polio in vitro plaque neutralization.|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||Titers||95% Confidence Interval|Geometric Mean
2822300|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2822454|NCT00365391|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, patients are followed up to 3 years after treatment|All 27 patients were analyzed.|||months||95% Confidence Interval|Median
2822301|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2822302|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose|GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.|One month after the infant series (6 months of age) and the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.|||mIU/mL||95% Confidence Interval|Number
2822303|NCT00366899|Other Pre-specified|Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 and after the toddler dose|OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group|||Titers||95% Confidence Interval|Geometric Mean
2822304|NCT00366899|Other Pre-specified|Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).|one month after infant series dose 2 and after the toddler dose|OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group|||% Achieving OPA Titer ≥1:8||95% Confidence Interval|Geometric Mean
2822305|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
2822306|NCT00366899|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose|Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.|One month after the infant series (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.|||percentage of participants||95% Confidence Interval|Number
2822307|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2822308|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2822309|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|One month after the 3-Dose Infant Series (at 5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2822310|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2822311|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2822312|NCT00366678|Primary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-Dose Infant Series (at 5 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Geometric Mean
2822313|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||EU/mL||95% Confidence Interval|Number
2822314|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Number
2822315|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Number
2822316|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2822317|NCT00366678|Secondary|Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose|GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2822318|NCT00366678|Secondary|Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
2822319|NCT00366678|Secondary|Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2822320|NCT00366678|Secondary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.|||percentage of participants||95% Confidence Interval|Number
2822333|NCT00366457|Secondary|Response Rate|Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|after at least one 28-day cycle of treatment|participants with response data available|||Participants|||Count of Participants
2823007|NCT00360698|Secondary|Daily Mean Plasma Glucose||at the end of treatment (week 24)|Modified ITT population, LOCF|||mg/dL||Standard Deviation|Mean
2822321|NCT00366678|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group|Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.|One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2822322|NCT00366626|Primary|Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed|Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.|On day 7 of treatment during limited access alcohol consuption in the bar/laboratory|All subjects who were randomized.|||Total number of drinks consumed||Standard Deviation|Mean
2822323|NCT00366626|Primary|"Natural Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period"||treatment days 1 - 5|All subjects who were randomized.|||Drinks per day||Standard Deviation|Mean
2822324|NCT00366548|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2822325|NCT00366548|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2822326|NCT00366548|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2822327|NCT00366548|Other Pre-specified|Percent of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.|||Percentage of Participants|||Number
2822328|NCT00366548|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2822329|NCT00366548|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2822330|NCT00366535|Primary|Fibromyalgia Impact Questionnaire|The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item self-administered measure to assess 3 areas of fibromyalgia (FM): function, overall impact, and symptoms. The total FIQ score was the primary outcome of the study. The total FIQ score is the sum of the 3 areas measured in the FIQ. The maximum possible total FIQ score is 100, with a minimum score of 10. The average FM patient scores about 50, severely afflicted FM patients are usually 70 and above. Data analysis is ongoing from data collected from study completers.|25 weeks|Total 56 patients enrolled, and 39 patients completed the study. 17 patients withdrawn from the study. Three of 39 patients were excluded from the data analysis because there had missing FIQ scores at Baseline and/or Week 12. The data from the study of the 36 participants with complete data sets was analyzed.|||units on a scale||Standard Deviation|Mean
2822331|NCT00366457|Secondary|Overall Survival|overall survival (OS) = time from study entry until death from any cause|5 years|participants who started treatment|||months||95% Confidence Interval|Median
2822334|NCT00366457|Primary|Time to Tumor Progression|"Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|all patients will be followed for a minimum of 4 months|participants who started treatment|||months||95% Confidence Interval|Median
2822335|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge|Day 3||||participants|||Number
2822336|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2||||participants|||Number
2822337|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1||||participants|||Number
2822338|NCT00366444|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|"Number of participants analyzed includes only the number of participants with at least a 30% reduction in pain intensity after the 1st dose (see previous outcome measure, #7).~Number of placebo patients is intentionally blank as the data (eg., upper CI) was not calculable."|||minutes||95% Confidence Interval|Median
2822339|NCT00366444|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose||||participants|||Number
2822340|NCT00366444|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hours post single dose||||units on a scale||Standard Deviation|Mean
2822341|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure, #4).~Number of patients in the placebo group is intentionally blank as the data was not calculable since less than 50% of the patients reported meaningful relief (ie, median cannot be calculated)."|||minutes||95% Confidence Interval|Median
2822342|NCT00366444|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
2822343|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous Outcome Measure #2)|||minutes||95% Confidence Interval|Median
2822344|NCT00366444|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose||||participants|||Number
2822345|NCT00366444|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy||||units on a scale||Standard Deviation|Mean
2822346|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2822347|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.|||percentage of participants|||Number
2822348|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.|||percentage of participants|||Number
2822349|NCT00366340|Primary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 months of age) and one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2822360|NCT00366249|Secondary|Number of Patients With Microbiologic Response of Eradication.|Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Microbiologically evaluable population without osteomyelitis.|||patients|||Number
2823008|NCT00360698|Secondary|Change in Glycosylated Haemoglobin (HbA1c) Value||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF|||percent||Standard Error|Least Squares Mean
2822350|NCT00366340|Primary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
2822351|NCT00366340|Primary|Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2822352|NCT00366340|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
2822353|NCT00366340|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.|||Percentage of Participants||95% Confidence Interval|Number
2822354|NCT00366340|Primary|Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
2822355|NCT00366340|Primary|Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.|Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
2822356|NCT00366340|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
2822357|NCT00366340|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
2822358|NCT00366301|Primary|Percentage Reduction in C-reactive Protein (CRP)||14 weeks|As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. Any subject having either or both 6 week and 14 week measures was included.|||Percent CRP Reduction||95% Confidence Interval|Mean
2822359|NCT00366275|Primary|Progression-free Survival|"PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first.~The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression."|every 3 months for the first year after autotransplant and every 6 months after the first year of follow up||||percent chance of PFS at 5 years||95% Confidence Interval|Number
2822361|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinical modified intent to treat population with osteomyelitis.|||patients|||Number
2822362|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinical modified intent to treat population without osteomyelitis.|||patients|||Number
2822363|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinically evaluable population with osteomyelitis.|||patients|||Number
2822364|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinically evaluable population without osteomyelitis.|||patients|||Number
2822365|NCT00366106|Secondary|Relative Dose Intensity of Bortezomib|Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.|Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)|Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.|||Relative dose intensity||Standard Deviation|Mean
2822366|NCT00366106|Secondary|Number of Participants With Treatment Response|Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.|Every 8 weeks from start of treatment until end of treatment||||Participants|||Number
2822367|NCT00366106|Secondary|Time to Progression (TTP)||TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months||||Months||Standard Deviation|Mean
2822368|NCT00366106|Primary|Incidence of Treatment-emergent Peripheral Neuropathy||Every 4 weeks from start of treatment until end of treatment||||Participants|||Number
2822369|NCT00366028|Primary|Effect Size of Improvement in Hand Hygiene Compliance|The effect size of improvement in hand-hygiene compliance was calculated by comparing the baseline three-month periods to the last three-month periods of the study. To evaluate the statistical significance of changes in proportion adherence over time, we ran a weighted least squares regression model with time (i.e. month) as the independent variable and adherence proportion as the dependent variable. The sample size in each data collection period was used as the weight. Our interest is in the statistical significance of the coefficient associated with time. To evaluate the practical significance of the change pre and post intervention, we examined the effect size associated with the change in proportion adherence in the first 3-month period of data collection and the last 3-month period. Effect size was calculated as 2*arcsin(sqr(p2)) - 2*arcsin(sqr(p1)). Using Cohen's criteria, an effect size of .2 is interpreted as small, .5 as medium and .8 as large.|3 months pre and post study intervention|This outcome measure was only assessed at the site (facility) level.|||effect size|Participants||Number
2822370|NCT00366028|Primary|Fidelity to the Organizational Model|"Final fidelity to the Organizational Model was assessed by averaging scores for each component of the model. Scores ranged from 0 (no evidence of that factor present) to 4 (factor fully present and used as intended). The 3 main components of the model included 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. Scores for each component of the model were measured by the study team using structured rating instruments based on data collected during interviews.~Sites with an overall fidelity score above 3.0 were considered to have high fidelity to the organizational model."|Fidelity was assessed at the end of the 3 year study.|This outcome measure was only assessed at the site (facility) level.|||units on a scale|Participants||Number
2822371|NCT00365989|Other Pre-specified|Number of Participants With Adverse Events||Within 1 month of treatment||||Participants|||Count of Participants
2822372|NCT00365989|Other Pre-specified|Mean Enhanced Sonication Normalized Thermal Dose Volume|The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.|During treatment|Of the 50 subjects treated, 39 were included in the thermal analysis per the protocol. Of the 11 subjects not eligible, 8 were not treated with at least 30% enhanced sonications. Three subjects received enhanced sonications at tissue depths greater that 70 mm from the skin line.|||cc/KJ/sonication||Standard Deviation|Mean
2822373|NCT00365989|Primary|Number of Adverse Events|The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.|Within 1 month of treatment||||Adverse Events|||Number
2822374|NCT00365976|Secondary|State-Trait Anxiety Inventory (STAI)|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)|Baseline, week 1, week 2, week 4|Data not collected.||||||
2822375|NCT00365976|Secondary|Short Form 36 Health Survey Questionnaire (SF-36)|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Baseline, week 1, week 2, week 4|Data not collected.||||||
2822376|NCT00365976|Secondary|Hamilton Depression Rating Scale (HAM-D-24)|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4||||units on a scale||Standard Deviation|Mean
2822377|NCT00365976|Secondary|Roland Morris Low Back Pain Inventory (RMLBPI)|"The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 yes-no items assessing potential disabilities.~Scores range from 0 (no disability) to 24 (severe disability)."|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4||||units on a scale||Standard Deviation|Mean
2822378|NCT00365976|Secondary|Patient Global Impression of Pain Ratings|Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)|postnaprosyn Baseline, Week 1, Week 2 week 4||||units on a scale||Standard Deviation|Mean
2822379|NCT00365976|Secondary|Insomnia Severity Index (ISI)|The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia).|Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4||||units on a scale||Standard Deviation|Mean
2822380|NCT00365976|Secondary|Sleep Quality Ratings|Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep|Postnaprosyn Baseline, Week 1, Week 2 week 4||||units on a scale||Standard Deviation|Mean
2822381|NCT00365976|Secondary|Number of Awakenings||Postnaprosyn Baseline, Week 1, Week 2 week 4||||awakenings||Standard Deviation|Mean
2822382|NCT00365976|Secondary|Wake Time After Sleep Onset||Postnaprosyn Baseline, Week 1, Week 2 week 4||||minutes||Standard Deviation|Mean
2822383|NCT00365976|Secondary|Mean Sleep Onset Latency (SOL)||Postnaprosyn Baseline, Week 1, Week 2 week 4||||minutes||Standard Deviation|Mean
2822384|NCT00365976|Secondary|Visual Analog Scale Pain Ratings (VAS)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain|Postnaprosyn baseline, Week 1, Week 2, Week 4||||units on a scale||Standard Deviation|Mean
2822385|NCT00365976|Primary|Mean Subjective Sleep Diary Derived Total Sleep Time (TST)|Nightly total sleep time was averaged from diary entries.|Postnaprosyn baseline, Week 1, week 2, week 4||||Minutes||Standard Deviation|Mean
2822386|NCT00365872|Other Pre-specified|Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort|To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this.|Up to 3 years|Participants evaluable for this measure|||participants|||Number
2822387|NCT00365872|Secondary|Participants With No Evidence of Disease at Follow-up|Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years.|3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
2822388|NCT00365872|Secondary|Occurrence of Postoperative Wound Complications|Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).|Up to 3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
2822389|NCT00365872|Secondary|Occurrence of Significant (>/= Grade 2) Toxicity|Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
2822390|NCT00365872|Primary|Overall Response Rate (ORR)|Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.|||participants|||Number
2822391|NCT00365859|Secondary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)|CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 96 patients did not have post-baseline evaluations for CY-BOCS, and were excluded from the efficacy analyses.|||units on a scale||Standard Deviation|Mean
2822452|NCT00365391|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|No patients were analyzed for this secondary outcome due to insufficient data.||||||
2822392|NCT00365859|Secondary|Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF|||units on a scale||Standard Deviation|Mean
2822393|NCT00365859|Secondary|Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
2822394|NCT00365859|Secondary|Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
2822395|NCT00365859|Secondary|Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF.The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
2822396|NCT00365859|Secondary|Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.|||units on a scale||Standard Deviation|Mean
2822397|NCT00365859|Secondary|CGI-Improvement Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement.|Week 52 (Endpoint, LOCF)|Efficacy Sample. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.|||units on a scale||Standard Deviation|Mean
2822398|NCT00365859|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.|||units on a scale||Standard Deviation|Mean
2822399|NCT00365859|Primary|Mean Change From Baseline By Time Period in BMI Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.|||Standard Deviations away from Population||Standard Deviation|Mean
2822400|NCT00365859|Primary|Mean Change From Baseline in Patient Body Mass Index (BMI)|The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height.|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample: Endpoint - Last Observation Carried Forward (LOCF)|||kg/m2||Standard Deviation|Mean
2822401|NCT00365859|Primary|Mean Change From Baseline by Time Period in Body Weight Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.|||Standard Deviations away from Population||Standard Deviation|Mean
2822402|NCT00365859|Primary|Mean Change From Baseline in Patient Weight||At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||kg||Standard Deviation|Mean
2822403|NCT00365859|Primary|Number of Potentially Clinically Relevant Vital Sign Abnormalities|Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample|||Participants|||Number
2822404|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities|"These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = to"|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
2822405|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities|Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
2822406|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities|Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
2822407|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities|Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males)|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample|||Participants|||Number
2822408|NCT00365859|Primary|Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2822409|NCT00365859|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2822410|NCT00365859|Primary|Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
2822411|NCT00365859|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs|Safety Population|||Participants|||Number
2822412|NCT00365846|Secondary|Kidney Allograft Survival||3 years||||participants|||Number
2822413|NCT00365846|Secondary|Incidence of Malignancies|Number of Participants Experiencing Malignancies|3 years||||participants|||Number
2822414|NCT00365846|Secondary|Incidence of Post-transplant Infection|"Event of post-transplant infection (more than one event might have been counted per participant)"|3 years||||event of infection|||Number
2822415|NCT00365846|Secondary|Patient Survival||3 years||||participants|||Number
2822416|NCT00365846|Secondary|Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)||3 years||||participants|||Number
2822417|NCT00365846|Primary|Incidence of Allograft Rejection||3 years||||participants|||Number
2822418|NCT00365794|Secondary|Change in Plasma Free Fatty Acids During Glucose Clamp||Baseline to 20 weeks||||grams||Full Range|Median
2822419|NCT00365794|Secondary|Change in Basal FFAs in Plasma|FFA (plasma free fatty acids) are measure of lipid metabolism|Baseline to week 20||||mEq/L||Full Range|Median
2822420|NCT00365794|Secondary|Change in HOMA-IR|HOMA-IR is a measure of insulin resistance|Baseline to week 20||||microU/L) x fasting glucose (nmol/L)/22||Full Range|Median
2822421|NCT00365794|Secondary|Plasma Lipids||Baseline to week 20||||mg/dL||Full Range|Median
2822422|NCT00365794|Secondary|Change in Skeletal Muscle Mass by DEXA|Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle.|Baselne to 20 weeks||||kilograms||Full Range|Median
2822423|NCT00365794|Secondary|Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO])|In the final analysis, total and regional carbohydrate metabolism during a 2-hr hyperinsulinemic euglycemic clamp (peripheral glucose disposal [Rd],hepatic glucose output [HGO]) were analyzed by mass transfer of glucose during both stages of the clamp relative to insulin levels.|Baseline and 20 weeks||||dL/min per μU/mL||Full Range|Median
2822424|NCT00365794|Secondary|Change in Percentage of Total Body Fat|Percentage of total body fat is quantified by DEXA scanning|Baseline and 20 weeks|Data not available for one subject|||percentage of total body fat||Full Range|Median
2822425|NCT00365794|Primary|Intramyocellular Lipid (IMCL)|IMCL is quantified by MR spectroscopy of the anterior tibialis muscle of the leg. The value is adjusted for creatine and reported as a ratio|Baseline to week 20|data not available for 5 subjects|||ratio||Full Range|Median
2822426|NCT00365794|Primary|Change in Hepatic Lipid|Amount of liver fat is highly predictive of insulin resistance. Hepatic fat is measured by MR spectroscopy and adjusted for H2O and results are reported as ratio of these two.|Baseline to week 20|Data not available for one subject|||ratio||Full Range|Median
2822427|NCT00365794|Primary|Change in Total Mass and Regional Adipose Adiposiy|Change in total body mass, total fat mass, trunk fat, and extremity fat|Baseline to 20 weeks|Data for one participant was not available|||kilograms||Full Range|Median
2822428|NCT00365768|Secondary|Number of Participants With Progression of Neuropathy||42 days||||participants|||Number
2822429|NCT00365768|Primary|Incidence of Vincristine-induced Peripheral Neuropathy||Up to 30 weeks from baseline while on Vincristine treatment||||participants|||Number
2822430|NCT00365716|Secondary|Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)||Through 36 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at Day 1 and PCR negative through Month 7 to the relevant HPV type, and must provide follow-up data after Month 7|||Incidence per 100 person-years|||Number
2822431|NCT00365716|Primary|Number of Subjects With Injection Site Adverse Experiences||Days 1-5 following any vaccination visit|All vaccinated subjects with adverse experience follow-up.|||Participants|||Number
2822432|NCT00365599|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|4 years, 7 months|All participants|||participants|||Number
2822433|NCT00365599|Secondary|Time to Progression (TTP)|The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 30 months|All participants|||months||Full Range|Median
2822453|NCT00365391|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, up to 3 years after treatment.|All 27 patients were included in the analysis.|||months||95% Confidence Interval|Median
2822434|NCT00365599|Primary|Number of Participants With Objective Response (OR)|The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.|24 weeks|All participants|||participants|||Number
2822435|NCT00365547|Secondary|Median Overall Survival|Defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|From Day 1 Until Death Occurred|Maximum number of days was 1349.|||Days||95% Confidence Interval|Median
2822436|NCT00365547|Secondary|Median Duration of Response|Defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to progressive disease. For subjects who do not progress or die, duration of response will be censored at the time of last contact.|Day of 1st Response Until Disease Progression of Death/Last Contact|Maximum number of days was 1277.|||Days||95% Confidence Interval|Median
2822437|NCT00365547|Secondary|Median Time to Response|Defined as the time from the start of treatment until first documented evidence of at least a partial tumor response.|From Day 1 Until Tumor Response|Maximum number of days for analysis was 104.|||Days||95% Confidence Interval|Median
2822438|NCT00365547|Secondary|Number of Tumor Responders|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).|From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year||||Participants|||Number
2822439|NCT00365547|Primary|Median Time to Disease Progression|Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.|From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)|All intent-to-treat patients enrolled were analyzed. Maximum number of days was 1349.|||Days||95% Confidence Interval|Mean
2822440|NCT00365508|Secondary|Rate of Compliance During the First 2 Weeks|Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence|2 weeks|Intent to treat|||participants|||Number
2822441|NCT00365508|Primary|24-hour Point Prevalence Abstinence at the 6-month Follow up||6-months|Intent to treat analysis (lost to follow-up = smoker)|||participants|||Number
2822442|NCT00365456|Primary|Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.|BMD was measured by Dual X-ray Absorptiometry (DXA).|12 months|All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward.|||Percentage Change||Standard Error|Least Squares Mean
2822443|NCT00365417|Secondary|Number of Patients With at Least One Surgical Complications (Wound Dehiscence, Infection, Seroma, or Hematoma).|Number of patients with at least one surgical complications (wound dehiscence, infection, seroma, or hematoma)|Two (2) years|Of the 45 patients, 43 patients had surgery and therefore 43 patients in this outcome.|||participants|||Number
2822444|NCT00365417|Secondary|Overall Survival|Percentage of patients alive.|2 years||||percentage of patients||95% Confidence Interval|Number
2822445|NCT00365417|Secondary|Progression-free Survival|Percentage of patients free from disease progression. Progression is determined using international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. At least a 20% increase in the sum of the longest diameter of the target lesions. Other manifestations of progressive disease would also be classified as disease progression, eg., appearance of one or more new lesions in the breast, regional lymph nodes or distant sites, unequivocal progression of existing non-target lesions, and appearance of inflammatory carcinoma on clinical exam.|2 years||||percentage of patients||95% Confidence Interval|Number
2822446|NCT00365417|Secondary|Cardiac Events|Events: Congestive Heart Failure; Cardiac Death|Assessments throughout; up to 18 months following study entry|Symptomatic cardiac toxicity was not observed in this study.|||cardiac events|||Number
2822447|NCT00365417|Secondary|Reported Adverse Events|Number of Adverse Events|Approximately 14 months||||events|||Number
2822448|NCT00365417|Secondary|Clinical Response Rate (cRR) of the Sequential Regimen|Clinical tumor measurements were required before study entry & before cycle 5 of chemotherapy (between AC & TX). Final tumor measurements were obtained 4-5 weeks after the last dose of chemotherapy. Clinical tumor assessments by physical examination were recommended before each chemotherapy cycle. The criteria proposed by the Response Evaluation Criteria in Solid Tumors Committee(RECIST) were used to define clinical response status. CR was defined as the disappearance of all lesions with no evidence of PD. PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions, using as reference the baseline sum longest diameter and/or the persistence of greater than or equal to 1 nontarget lesion without worsening of any other clinical manifestations of disease. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions, or unequivocal progression of existing lesions.|Approximately 6 months||||percentage of patients||95% Confidence Interval|Number
2822449|NCT00365417|Secondary|pCR in the Breast and Nodes|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel nodes|Approximately 7 months||||participants|||Number
2822450|NCT00365417|Primary|Pathologic Complete Response (pCR) in the Breast|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen|Approximately 7 months||||participants|||Number
2822451|NCT00365391|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|All 27 patients were used in this analysis.|||months||95% Confidence Interval|Median
2822455|NCT00365391|Primary|Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).|Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters.|Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment.|Four patients were inevaluable because they were off the study prior to first radiologic evaluation for objective response.|||participants|||Number
2822456|NCT00365378|Primary|Serum Anti-HPV 16 Geometric Mean Titers|"The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as 6.0."|Month 7|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide serology data at Month 7|||milliMerck units/ml (mMU/ml)||95% Confidence Interval|Geometric Mean
2822457|NCT00365378|Primary|Incidence of HPV 16-related CIN1, CIN2 or C1N3|Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide follow-up data after Month 7|||Incidence per 100 person-years|||Number
2822458|NCT00365378|Primary|Incidence of Persistent HPV 16 Infection|Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR (Polymerase chain reaction) negative to HPV 16 through Month 7, and must provide follow-up data after Month 7|||Incidence per 100 person-years|||Number
2822459|NCT00365365|Secondary|Disease-free Survival (DFS) Rate|"DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice.~For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free."|from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months|Intent-to-treat population - All randomized participants|||percentage of participants|Participants|95% Confidence Interval|Number
2822460|NCT00365365|Secondary|Safety - Number of Participants With Adverse Events (AE)|"An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment.~A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important.~Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period."|from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.|Safety population - participants who received at least one dose of study medication|||participants|||Number
2822461|NCT00365365|Primary|Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)|"Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.~Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF."|from the first dose of study medication up to the end of follow-up (up to 3 yrs)|Safety population - participants who received at least one dose of study medication|||participants|||Number
2822462|NCT00365352|Secondary|Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)|The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom.|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||hours||95% Confidence Interval|Median
2822463|NCT00365352|Secondary|Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)|RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day.|Week 12|MITT Population. The number analyzed represents participants within the MITT Population who reported no RLS symptoms at the end of Week 12.|||participants|||Number
2822505|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||percentage of labeled cells||Standard Deviation|Mean
2823009|NCT00360698|Secondary|Glycosylated Haemoglobin (HbA1c) Value||at the end of treatment (week 24)|Modified ITT population, LOCF|||percent||Standard Deviation|Mean
2822464|NCT00365352|Secondary|Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF|The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline and Week 12|MITT Population: The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822465|NCT00365352|Secondary|Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||hours||Standard Deviation|Mean
2822466|NCT00365352|Secondary|Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Basline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822467|NCT00365352|Secondary|Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822468|NCT00365352|Secondary|Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822469|NCT00365352|Secondary|Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF|"The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from 0 (Not all all) to 4 (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination)."|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822470|NCT00365352|Secondary|Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF|The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination).|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
2822471|NCT00365352|Secondary|Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF|"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week."|End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
2822472|NCT00365352|Secondary|Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Week 1 and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
2822506|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin : (N = 17 participants).|||percentage of labeled cells||Standard Deviation|Mean
2822473|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF|The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822474|NCT00365352|Secondary|Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF|"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
2822475|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF|The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822476|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF|Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Popultion. The number of participants assessed varies due to incomplete/missing data.|||minutes||Standard Deviation|Mean
2822477|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF|Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time - lights out time) - time to fall asleep - time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||hours||Standard Deviation|Mean
2822478|NCT00365352|Secondary|Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||responders|||Number
2822479|NCT00365352|Secondary|Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Basline and Week 12|Participants included in the MITT Population with a known RLS treatment history|||participants|||Number
2822480|NCT00365352|Secondary|Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and the End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822481|NCT00365352|Secondary|Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822482|NCT00365352|Secondary|Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822483|NCT00365352|Secondary|The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I|The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method.|Baseline (Day 1) to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||weeks||95% Confidence Interval|Median
2822484|NCT00365352|Secondary|Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF|"The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved."|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
2822485|NCT00365352|Secondary|Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||participants|||Number
2822486|NCT00365352|Secondary|Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2822487|NCT00365352|Primary|"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"|"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being very much worse. Participants with a response of much improved or very much improved were classified as responders."|Week 12|MITT Population|||participants|||Number
2822488|NCT00365352|Primary|Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)|The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and Week 12|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who also satisfied all of the following conditions: (1) completed the IRLS Rating Scale at Baseline; and (2) completed at least one on-treatment IRLS Rating Scale score during the treatment period|||scores on a scale||Standard Deviation|Mean
2822489|NCT00365300|Primary|Number of Patients Withdrawn From Study Due to Lack of Efficacy.|Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.|4 weeks double-blind|The analysis population was the Modified Intent to Treat, which included all GERD patients who completed the 4 week open-label treatment phase, were randomized into the 4 week double-blind phase, and took at least one dose of double-blind treatment.|||patients|||Number
2822490|NCT00365274|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Up to 5 years||||percentage of participants|||Number
2822491|NCT00365261|Secondary|Opiate Dosing From Patient Controlled Analgesia|Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.|2 days post dosing||||mg||Inter-Quartile Range|Median
2822492|NCT00365261|Primary|Patient Self-report Data on Fatigue|Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).|2 days post treatment||||scores on a scale||Standard Error|Mean
2822493|NCT00365261|Primary|Pain|"Pain was assessed with a 10-cm visual analog scale (0 = no pain at all; 10 = severe, uncontrolled pain)."|post dosing||||scores on a scale||Standard Error|Mean
2822494|NCT00365209|Secondary|Number of Participants at Each Adverse Event Grade Level||Baseline to 30 days|These participants completed the study. The data is from the final dataset which was available in 2013 following the publication.|||participants|||Number
2822495|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Plasma Concentrations|Post-treatment curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
2822496|NCT00365209|Secondary|Baseline Curcumin Conjugates Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
2822497|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcumin group and 18 participatns from 4g curcumin group). In 2g group, a total of 13 samples with detectable levels were analyzed. In 4g group, a total of 12 samples with detectable levels were analyzed.|||µg/g protein|Participants|Standard Deviation|Mean
2822498|NCT00365209|Secondary|Baseline Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 19 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin conjugates in rectal mucosa were found in 0 participants in the 2g arm and 1 participant on the 4g arm. Therefore, 0 samples from the 2g arm and 1 sample from the 4g arm are reported here.|||µg/g protein|Participants|Standard Deviation|Mean
2822499|NCT00365209|Secondary|Post-treatment Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 2 participants in the 4g arm; therefore, 2 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
2822500|NCT00365209|Secondary|Baseline Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 4 participants in the 4g arm; therefore, 4 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.|||µg/mL|Participants|Standard Deviation|Mean
2822501|NCT00365209|Secondary|Post-treatment Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcmin, and 18 participants from 4 g curcumin). In 2g group, a total of 5 samples with detectable levels were analyzed. In 4g group, a total of 3 samples with detectable levels were analyzed.|||µg/g protein|Participants|Standard Deviation|Mean
2822502|NCT00365209|Secondary|Baseline Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 18 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin in rectal mucosa were found in 1 participant in the 2g arm and none in participants on the 4g arm. Therefore, only 1 sample from the 2g arm and 0 samples from the 4g arm are reported here.|||µg/g protein|Participants|Standard Deviation|Mean
2822503|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||percentage of labeled cells||Standard Deviation|Mean
2822504|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)|||percentage of labeled cells||Standard Deviation|Mean
2822507|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g crucumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||percentage of labeled cells||Standard Deviation|Mean
2822508|NCT00365209|Primary|Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822509|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)|||percentage of labeled cells||Standard Deviation|Mean
2822510|NCT00365209|Secondary|Changes in Total Aberrant Crypt Foci (ACF) Number|Changes in total aberrant crypt foci (ACF) number = Number of ACF at pre-treatment - Number of ACF at post-treatment|Baseline to 30 days|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)|||Number of ACF||Full Range|Median
2822511|NCT00365209|Secondary|Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance|The protein levels for each enzyme will be expressed as an absolute change from baseline and graphed against % change of its enzyme product in the same individual. The degree of correlation between these parameters will be assessed by either Pearson's correlation coefficient or Spearman's rank order correlation coefficient.|Baseline to 30 days|There is not enough tissue for the analysis, so no data is provided.||||||
2822512|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822513|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822514|NCT00365209|Secondary|Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822515|NCT00365209|Secondary|Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822516|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|At 30 Day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822517|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822518|NCT00365209|Primary|Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants) and Stage2 4 g curcumin: (N = 19 participants)|||µg/g protein||Standard Deviation|Mean
2822519|NCT00365144|Secondary|Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker||21 weeks|Only patients with an elevated baseline CA19-9 (>2x ULN) were included in this analysis (n = 26).|||Participants|||Count of Participants
2822520|NCT00365144|Secondary|Time to Tumor Progression|Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease.|from initial therapy to the first objective documentation of tumor progression||||Days||95% Confidence Interval|Median
2822521|NCT00365144|Secondary|Objective Response as Measured by RECIST Criteria|Participants experiencing objecting response, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|21 weeks||||participants|||Number
2822522|NCT00365144|Primary|Safety and Toxicity|Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)|21 weeks||||participants|||Number
2822523|NCT00365144|Primary|Overall Survival Rate at 6 Months|Number of participants alive at 6 months|6 months|All participants were followed for survival|||participants|||Number
2822524|NCT00365105|Secondary|Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year|The EQ-5D-3L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Change at one year is calculated as one-year score - baseline score with positive change indicating improved quality of life.|Baseline and 1 year|Eligible patients with EQ-5D-3L scores at baseline and one year|||units on a scale||Standard Deviation|Mean
2822525|NCT00365105|Secondary|Change in Brief Pain Inventory (BPI) at One Year|"The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain. The BPI assesses severity (pain at its worst, least, average, and now), and interference (how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Patients rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function on a scale of 0 to 10, with 0=no pain/interference and 10=interferes completely/worst pain imaginable."|Baseline and 1 year|Eligible patients with baseline and one-year BPI score|||units on a scale||Inter-Quartile Range|Median
2822526|NCT00365105|Secondary|Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year|The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change score at one year is calculated as one year score - baseline score with a positive change score indicating improvement in QOL.|Baseline and 1 year|Eligible patients with FACT-G scores at baseline and one year|||units on a scale||Inter-Quartile Range|Median
2822527|NCT00365105|Secondary|Overall Survival|Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to last follow-up. Maximum follow-up at time of analysis was 101.7 months.|Eligible patients|||months||95% Confidence Interval|Median
2822528|NCT00365105|Secondary|Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year|Skeletal-related events are defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.|From randomization to 1 year|Eligible patients|||Participants|||Count of Participants
2822529|NCT00365105|Primary|Time to Development of a Malignant Skeletal-related Events (SRE)|Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.|From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.|Eligible patients|||months||95% Confidence Interval|Median
2822530|NCT00365053|Secondary|Histone Acetylation by IHC and Western Blotting|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline and at 4 hours after last dose of PXD101 on day 5|IHC data were not collected.||||||
2822531|NCT00365053|Secondary|Apoptosis by TUNEL Assay|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline|Assay data were not collected.||||||
2822532|NCT00365053|Secondary|Toxicity Profile|Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 3 years||||Participants|||Count of Participants
2822533|NCT00365053|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years||||Months||95% Confidence Interval|Mean
2822534|NCT00365053|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 3 years||||Months||95% Confidence Interval|Median
2822535|NCT00365053|Primary|Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years||||percentage of participants|||Number
2822536|NCT00364949|Primary|Infant Birth Weight (Male and Female)||birth|Birth weight of the male and female infants.|||gram||Standard Deviation|Mean
2822537|NCT00364949|Primary|Dehydroepiandrosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/ml||Standard Deviation|Mean
2822538|NCT00364949|Primary|Dihydrotestosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||pg/ml||Standard Deviation|Mean
2822539|NCT00364949|Primary|17-hydroxyprogesterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/dl||Standard Deviation|Mean
2822540|NCT00364949|Primary|Testosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/dl||Standard Deviation|Mean
2822541|NCT00364949|Primary|Androstenedione Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.|||ng/dl||Standard Deviation|Mean
2822542|NCT00364949|Primary|Estradiol Level in Female Offspring|The blood that were analyzed were taken from cord blood and not from the offspring.|One time sampling from the cord blood|The number of the participants analyzed only included the levels for the female offspring.|||pg/ml||Standard Deviation|Mean
2822553|NCT00364845|Secondary|Number of Participants With Hemoglobin (Hb) ≥ 110 g/L|Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.|Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data|||Participants|||Number
2822543|NCT00364923|Secondary|Overall Survival Per Independent Central Review|Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.|Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.|Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.|||Months||Full Range|Median
2822544|NCT00364923|Secondary|Progression-free Survival Per Independent Central Review|Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status & survival. Pts who did not have response assessments after baseline were censored at treatment day 1.|Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.|||Days||Full Range|Median
2822545|NCT00364923|Secondary|Duration of Response Per Independent Central Review|Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence & reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.|Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.|||Days||Full Range|Median
2822546|NCT00364923|Primary|Response Rate Per Independent Central Review|Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.|Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.|||of Patients who Responded|||Number
2822547|NCT00364858|Secondary|Mean Change From Baseline in Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation|The mean composite scores (0 being worst and 100 being best) for both treatment groups approximated those of the general population at baseline. Composite score - The overall composite scores were comprised of a standardized physical and mental component score.|Baseline and Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.|||Units on a scale||Standard Deviation|Mean
2822548|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation.|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Month 24/Discontinuation. The mean composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.|||Units on a scale||Standard Deviation|Mean
2822549|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Baseline|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Baseline. Composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Baseline|Quality of life was evaluated and measured by the SF-36 questionnaire.|||Units on a scale||Standard Deviation|Mean
2822550|NCT00364858|Primary|Number of Participants With Clinical Success at Month 24/Discontinuation|Patients are considered to be a clinical success if ALL of the following are met: The patient's hemoglobin does not fall more than 1.25g/dL for women or 1.5 g/dL for men below the patient's baseline value, platelet count does not fall more than 25% below the patient's baseline value or does not fall below 80,000 mm3, liver and spleen volumes are not greater than 20% above the patient's baseline value, no evidence of bone disease progression, including no incidence of pathologic fractures, medullary infarctions, lytic lesions or avascular necrosis and has had no bone crises during the study.|Month 24 (or at time of discontinuation)|Intent-to-Treat (ITT) Population. All patients who enrolled in the study and received AT LEAST ONE infusion were included in the ITT population.|||patients|||Number
2822551|NCT00364845|Secondary|Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data|||Units on a scale||95% Confidence Interval|Mean
2822552|NCT00364845|Secondary|Mean Hemoglobin During the Evaluation Period||Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data|||g/L||95% Confidence Interval|Mean
2822554|NCT00364845|Primary|Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data.|||Units on a scale||Standard Error|Mean
2822555|NCT00364832|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
2822556|NCT00364832|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
2822557|NCT00364832|Secondary|Mean Change in Pulse Rate|Mean change in pulse rate was reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug. Participants with available data at the time of evaluation were analyzed.|||Beats per minute||Standard Deviation|Mean
2822558|NCT00364832|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Millimeters of Mercury||Standard Deviation|Mean
2822559|NCT00364832|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.|||Percentage of Hct||Inter-Quartile Range|Median
2822560|NCT00364832|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.|||gram per deciliter||Inter-Quartile Range|Median
2822561|NCT00364819|Secondary|Change in Serum Alkaline Phosphatase|The difference in serum alkaline phosphatase from Baseline to Week 52|52 Weeks||||U/L||Standard Deviation|Mean
2822562|NCT00364819|Secondary|Change in Serum Immunoglobulin M|The difference in serum immunoglobulin M from Baseline to Week 52|52 Weeks||||mg/dL||Standard Deviation|Mean
2822563|NCT00364819|Secondary|Change in Serum Immunoglobulin A|The difference in serum immunoglobulin A from Baseline to Week 52|52 Weeks|1 subject with missing data.|||mg/dL||Standard Deviation|Mean
2822564|NCT00364819|Secondary|Change in Serum Immunoglobulin G|The difference in serum immunoglobulin G from Baseline to Week 52|52 Weeks||||mg/dL||Standard Deviation|Mean
2822565|NCT00364819|Primary|Number of Participants With Adverse Events||52 weeks||||Participants|||Count of Participants
2822566|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.|||percentage of CD4 cells||Inter-Quartile Range|Median
2822596|NCT00364689|Secondary|Number of Hospitalization Days for All Causes||Month 7|Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.||||||
2822567|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.|||cells/mm^3||Inter-Quartile Range|Median
2822568|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.|||log10 c/mL||Inter-Quartile Range|Median
2822569|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.|||participants|||Number
2822570|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.|||participants|||Number
2822571|NCT00364793|Secondary|Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||h||Standard Deviation|Mean
2822572|NCT00364793|Secondary|CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
2822573|NCT00364793|Secondary|CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2822574|NCT00364793|Secondary|AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
2822597|NCT00364689|Primary|Changes in Psychometric Testing During Study Period||Month 7|Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.||||||
2825132|NCT00343564|Secondary|Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1||Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose||||ng/mL||Standard Deviation|Mean
2822575|NCT00364793|Secondary|Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were <LLOQ in all age groups except >=6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were <LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2822576|NCT00364793|Secondary|Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population|PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).|Baseline to Week 48|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC<110 µM•h and number of participants with AUC>=110 µM•h.|||participants|||Number
2822577|NCT00364793|Secondary|Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound|At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.|Baseline to Week 48|Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA > 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.|||participants|||Number
2822578|NCT00364793|Secondary|Number of Participants With Hematologic Abnormalities - Treated Participants|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
2822579|NCT00364793|Secondary|Number of Participants With Serum Chemistry Abnormalities - Treated Participants|Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
2822580|NCT00364793|Secondary|Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants|Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
2822581|NCT00364793|Secondary|Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to <LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: < 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).|||participants|||Number
2822582|NCT00364793|Secondary|Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events|Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).|Baseline to Week 96|All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.|||participants|||Number
2822583|NCT00364793|Primary|Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
2822584|NCT00364793|Primary|Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2822585|NCT00364793|Primary|Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||µM•h||Geometric Coefficient of Variation|Geometric Mean
2822586|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.|||percentage of CD4 cells||Inter-Quartile Range|Median
2822587|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.|||cells/mm^3||Inter-Quartile Range|Median
2822588|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Week 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.|||log10 c/mL||Inter-Quartile Range|Median
2822589|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
2822590|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
2822591|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
2822592|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.|||participants|||Number
2822593|NCT00364793|Primary|Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2822594|NCT00364689|Secondary|Rate of Adverse Events With Rifaximin Treatment||Month 7|Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.||||||
2822595|NCT00364689|Secondary|Death or Survival to Liver Transplantation||Month 7|Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.||||||
2822598|NCT00364689|Primary|Number of Hospitalizations for Hepatic Encephalopathy (HE)||Month 7|Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.||||||
2822599|NCT00364611|Secondary|Number of Participants With Adverse Events (AE)|"An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs).~An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important."|From treatment initiation to 30 days after the last dose of study treatment|Safety population: all participants who received at least one dose of study medication|||participants|||Number
2822600|NCT00364611|Secondary|Overall Survival (OS) Time|"OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.~OS time was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.|||days|Participants|Inter-Quartile Range|Median
2822601|NCT00364611|Secondary|Duration of Response (DR)|"DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression.~Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy.~DR was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Participants with a documented response of CR or PR.|||days|Participants|95% Confidence Interval|Median
2822602|NCT00364611|Secondary|Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria|"Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD).~According to RECIST~CR was the disappearance of all tumor lesions~PR was a pre-defined decrease in the size of tumor lesions~SD was neither sufficient decrease in tumor size to qualify for PR or sufficient increase to qualify for PD.~Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD)."|From treatment initiation to June 2011|Intent-to-treat: all registered participants.|||participants|||Number
2822603|NCT00364611|Secondary|Confirmed Overall Response (OR) Based on RECIST Criteria|"Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST~CR was the disappearance of all tumor lesions~PR was a pre-defined decrease in the size of tumor lesions.~To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.|||participants|||Number
2822604|NCT00364611|Primary|Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest of the following documented dates:~PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance)~symptomatic deterioration~death.~Time to PFS was estimated from Kaplan-Meier Plots."|From treatment initiation to PFS event (up to June 2011)|Intent-to-treat population: all registered participants|||days|Participants|95% Confidence Interval|Median
2822605|NCT00364611|Primary|Progression-free Survival (PFS) Rate: Percentage of Participants With PFS|"PFS was the time from registration to first documentation of~progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance~symptomatic deterioration~death due to any cause (in absence of PD).~The Percentage of participants with PFS is reported.~For the analysis, participants were censored~on the last available tumor assessment date on study treatment if they~had no PFS event~were on anticancer therapy not related to study treatment~on the registration date if they~did not receive study drug~had no post baseline tumor assessment"|Up to 6 months and 12 months after treatment initiation|Intent to treat population: all registered participants|||percentage of participants||95% Confidence Interval|Number
2822606|NCT00364533|Secondary|The SPID at 12, 24, and 72 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|3 days|Due to termination of trial, results were not analyzed.||||||
2822607|NCT00364533|Secondary|Time to First Rescue Pain Medication.||3 days|Due to termination of trial, results were not analyzed.||||||
2822608|NCT00364533|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|48 hours|Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.|||score on a scale||Standard Deviation|Mean
2822609|NCT00364377|Primary|Lowering of Fasting Glucose|fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study|8 weeks|Analysis was per protocol - all participants completed the intervention|||mmol/l||Standard Error|Mean
2822619|NCT00364182|Secondary|HRPQ Score: Hours Lost From Work or School at 48 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|48 hours post-bleed|ITT|||hours||Standard Deviation|Mean
2823233|NCT00359788|Secondary|FVC at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2822610|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough|"Cough was assessed using Question 1 (How much did you cough) of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||Weeks||Inter-Quartile Range|Median
2822611|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea|"Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 (Were you short of breath) and Question 3 of the QLQ-C30 (Were you short of breath when you rested), Questions 4 (Were you short of breath when you walked) and 5 (Were you short of breath when you climbed stairs) of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||Weeks||Inter-Quartile Range|Median
2822612|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain|"Pain was assessed as the average score of two items: Question 9 (Have you had pain) and 19 (Did pain interfere with your daily activities) of the QLQ-C30.~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit||||Weeks||Inter-Quartile Range|Median
2822613|NCT00364351|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.|RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression||||Participants|||Number
2822614|NCT00364351|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months||||Participants|||Number
2822615|NCT00364351|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||Full Range|Median
2822616|NCT00364351|Primary|Progression-Free Survival (PFS)|"Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.~Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions."|progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.||||Weeks||Full Range|Median
2822617|NCT00364286|Primary|Participants With Objective Response|Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR.|up to 3 months|Three participants were not evaluable for response due to early discontinuation of treatment (0-3 days).|||Participants|||Number
2822618|NCT00364182|Secondary|36-Item Short-Form Health Survey (SF-36): Physical Functioning Domain|SF-36: standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The physical functioning domain score was an average of the individual physical functioning question scores across all time points, which was scaled 0-100 (100=highest level of functioning).|Weeks 16, 32, and 56|ITT; N=number of participants with evaluable data.|||units on a scale||Standard Deviation|Mean
2822620|NCT00364182|Secondary|Health-Related Productivity Questionnaire (HRPQ) Score: Hours Lost From Work or School at 24 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|24 hours post-bleed|ITT|||hours||Standard Deviation|Mean
2822621|NCT00364182|Secondary|Acute Pain After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night and included a Brief Pain Inventory (BPI): self-reported scale that measured severity of pain experienced over the past 24 hours. Questions included How much pain right now? 0 (no pain) to 10 (pain as severe as you can imagine).|24 and 48 hours post-bleed|ITT|||units on a scale||Standard Deviation|Mean
2822622|NCT00364182|Secondary|Quality of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How would you describe the quality of your sleep last night? 1=Very Good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor. Reported as quality of sleep during study.|24 and 48 hours post-bleed|ITT|||Units on a scale||Standard Deviation|Mean
2822623|NCT00364182|Secondary|Amount of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How long do you think you slept last night? Reported as average duration of sleep during study.|24 and 48 hours post-bleed|ITT|||hours||Standard Deviation|Mean
2822624|NCT00364182|Primary|Annualized Number of Bleeding Episodes|Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)|Baseline up to Week 56|Intention-to-treat (ITT) population: all enrolled participants|||episodes||95% Confidence Interval|Least Squares Mean
2822625|NCT00364156|Primary|Biochemically Verified 7-day Point Prevalence Abstinence|To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.|End of Treatment (week 24)|Intention to Treat analysis (ITT)|||Participants|||Number
2822626|NCT00364130|Secondary|Change in QCT Tibia Trabecular Volumetric BMD at 12 Months|We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)|12 months||||cm^3||Standard Deviation|Mean
2822627|NCT00364130|Secondary|Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months|We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months|12 months||||Z-score||Standard Deviation|Mean
2822628|NCT00364130|Secondary|Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA|12 months||||Z-score||Standard Deviation|Mean
2822629|NCT00364130|Secondary|Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months|12months||||Z-score||Standard Deviation|Mean
2822630|NCT00364130|Secondary|Change in Posteroanterior Lumbar Spine Areal BMD Z-score|We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA|12 months||||Z-score||Standard Deviation|Mean
2822631|NCT00364130|Primary|Change in Spine Volumetric BMD Z-score at 12 Months|We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.|||Z-score||Standard Deviation|Mean
2822632|NCT00364130|Primary|Change in Tibia Cortical Area Z-score 12 Months|We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.|||Z-score||Standard Deviation|Mean
2822633|NCT00364130|Primary|Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months|"We calculated the mean change in tibia trabecular volumetric BMD Z-score between baseline and 12 months, as measured by peripheral quantitative computed tomography (pQCT).~The Z-score, or Standard Deviation Score, is a measure of the number of standard deviations that an individual is above or below the median value in a healthy child or adolescent of the same age, sex and race. For example, a Z-score of 0 means that an individual's result is equivalent to the 50th percentile in a healthy population. A Z-score of -1.0 means that an individual's result is equovalent to the 16th percentile in a healthy population."|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.|||Z-score||Standard Deviation|Mean
2822634|NCT00364013|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.|Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX’, but received ‘FOLFOX Alone’ so is counted in that group.|||participants|||Number
2822635|NCT00364013|Secondary|Duration of Response|Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set: Responders|||months||95% Confidence Interval|Median
2822636|NCT00364013|Secondary|Time to Progression|Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.|From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
2823234|NCT00359788|Secondary|FVC at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2822637|NCT00364013|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review).|||percentage of participants||95% Confidence Interval|Number
2822638|NCT00364013|Secondary|Overall Survival|The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.|From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
2822639|NCT00364013|Primary|Progression-free Survival|Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.|From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)|||months||95% Confidence Interval|Median
2822640|NCT00363896|Primary|Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks|Week 12|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
2822641|NCT00363896|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Percentage of Patients|||Number
2822642|NCT00363896|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|"Time to first moderate or severe exacerbation:~Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation."|Week 52|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Days||95% Confidence Interval|Median
2822643|NCT00363896|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks|Week 28|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
2822644|NCT00363883|Secondary|Progression-free Survial|Will be estimated using the product-limit method of Kaplan and Meier. Progression defined using RECIST v1.0 criteria, at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions.|assessed up to 26 weeks||||months||95% Confidence Interval|Median
2822645|NCT00363883|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|Up to 26 weeks||||months||95% Confidence Interval|Median
2822646|NCT00363883|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Response assessed after every 2 cycles (6 weeks) up to 26 weeks||||percentage of patients|||Number
2822647|NCT00363805|Primary|Change in Urinary 8-F2-isoprostanes Levels|the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identity of the analyte was confirmed in the sample.|||ng/mg creatinine||Standard Deviation|Mean
2822648|NCT00363805|Primary|Change in Urinary 8-hydroxydeoxyguanosine Levels|the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identify of the analyte was confirmed in the sample.|||ng/mg creatinine||Standard Deviation|Least Squares Mean
2822649|NCT00363779|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 months||||Participants|||Number
2825150|NCT00343382|Secondary|Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|End of 6 weeks||||participants|||Number
2822650|NCT00363779|Primary|Changes in Gene Expression Patterns|The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.|Baseline and 12 weeks|This outcome measure was not performed because there were insufficient data points to provide any statistical power.||||||
2822651|NCT00363766|Secondary|Number of Participants With Adverse Events (Safety)|Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.|First treatment dose up to 25.23 months|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2822652|NCT00363766|Secondary|Duration of Stable Disease|Duration of stable disease (SD) is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented stable disease or better to first date of progressive disease up to 10.35 months|All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.|||months||90% Confidence Interval|Median
2822653|NCT00363766|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to progressive disease or death up to 10.35 months|Since there were zero participants with CR or PR, the duration of response could not be analyzed.||||||
2822654|NCT00363766|Secondary|Overall Survival Time|Defined as the time from date of first dose to the date of death due to any cause.|First treatment dose to death due to any cause up to 25.23 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
2822655|NCT00363766|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY573636||Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)|Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2822656|NCT00363766|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate is the percentage of participants with complete response (CR) + partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|First treatment dose to measured progressive disease or death due to any cause up to 10.35 months|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2822657|NCT00363766|Secondary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|First treatment dose to measured progressive disease or death from any cause up to 10.35 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
2822658|NCT00363766|Primary|Time to Progression|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|First dose to measured progressive disease or death from study disease up to 10.35 months|All enrolled participants who received at least 1 dose of study drug.|||months||90% Confidence Interval|Median
2822659|NCT00363675|Primary|Moberg Pickup Test|The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.|Seconds to pick up all 12 objects|A convenience sample was planned for this study.|||Seconds||Full Range|Median
2822660|NCT00363675|Primary|Grip Strength|This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.|Baseline|Convenience sample was planned for this study.|||Pounds||Full Range|Median
2822661|NCT00363675|Primary|Range of Motion, Total Active Motion (TAM)|Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.|Baseline|Convenience sample was planned for ths study.|||Degrees||Full Range|Median
2822662|NCT00363675|Primary|Blocks & Box (Standardized Test).|Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.|Baseline|Convenience sample was planned for this study.|||Blocks||Full Range|Median
2822663|NCT00363649|Secondary|Early Discontinuation|Number of participants unable to complete protocol-specified treatment due to toxicity.|1 year|This outcome includes all participants who were either started on an arm or crossed over to an arm.|||Participants|||Count of Participants
2822664|NCT00363649|Secondary|Disease-free Survival|Median number of days to progression of disease in participants who stopped all treatment as directed by the protocol.|Up to 8 years|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||days||Full Range|Median
2822665|NCT00363649|Secondary|Time to Complete Molecular Remission|Number of months from randomization to molecular remission as defined by polymerase chain reaction negativity.|Up to 27 months|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||months||95% Confidence Interval|Median
2822666|NCT00363649|Primary|Complete Remission Rate|Percentage of patients who achieved molecular remission as defined by polymerase chain reaction negativity.|Up to 18 months|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||percentage of participants|||Number
2822667|NCT00363649|Primary|Progression-free Survival|Number of patients alive and without disease progression or relapse|1 year after treatment has been stopped|Crossover participants were not analyzed for this outcome. This is as per the analysis plan written in this protocol.|||Participants|||Count of Participants
2822668|NCT00363545|Secondary|Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes|The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.|From the first vaccine dose (Dose 1) up to Month 4|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.|||Subjects|||Number
2822669|NCT00363545|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (from Day 0 to Month 4)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2822670|NCT00363545|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
2822671|NCT00363545|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were cough/runny nose, diarrhea, fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.|||Subjects|||Number
2822672|NCT00363545|Secondary|Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies|Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the ATP cohort for immunogenicity stool analysis subset, defined as the first 200 subjects for whom pre-vaccination stool samples were available and with available anti-rotavirus IgA antibody results at post sampling time point or with vaccine virus in stools collected after the first vaccine dose up to Month 4.|||Subjects|||Number
2822673|NCT00363545|Secondary|Concentrations of Anti-rotavirus IgA Antibodies|Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.|||U/mL||95% Confidence Interval|Geometric Mean
2822674|NCT00363545|Primary|Number of Seroconverted Subjects Against Human Rotavirus|A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.|At 1 to 2 months after the second vaccine dose (Months 3-4)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.|||Subjects|||Number
2822675|NCT00363480|Secondary|Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements|Frequencies of participants with at least one (near-) incident associated with peak flow measurements were recorded. analysis was done on safety population.|Up to Week 12|Safety Set.|||participants|||Number
2822676|NCT00363480|Secondary|Assessment of Tolerability by Change From Baseline of Pulse Rate|Pulse rate was recorded over time (Visit 1, 3, 4, 5, and 6). Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.|Baseline (Visit 3) up to Week 12|Safety Set. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
2822677|NCT00363480|Secondary|Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were recorded over time (Visit 1, 3, 4, 5, and 6). Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.|Baseline (Visit 3) up to Week 12|Safety Set. Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2823083|NCT00360360|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months||||months||95% Confidence Interval|Median
2822678|NCT00363480|Secondary|Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE|An AE is any untoward medical occurrence in a participant or clinical AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. Number of participants with at least one treatment emergent serious and, non-serious AE were reported.|Up to Week 12|Safety Set.|||Participants|||Number
2822679|NCT00363480|Secondary|Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment|AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. Number of participants with AE who lead to change in asthma treatment were reported.|Up to Week 12|Safety Set.|||Participants|||Number
2822680|NCT00363480|Secondary|Number of Participants With Emergency Visits Due to Asthma|Frequencies of emergency visits per participant were recorded during treatment period. Only the participants at risk were considered when calculating the incidence rates.|Up to week 12|Safety set comprised of participants who received study medication at least once s participants who did not administer any study medication (those who returned all study medication dispensed) were not included in the Safety Set. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2822681|NCT00363480|Secondary|Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12|Number of nights with no night time awakening were recorded at Week 12. Baseline was the last corresponding time period immediately prior to Visit 3.|Baseline (Visit 3) and week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Percent Change||Standard Deviation|Mean
2822682|NCT00363480|Secondary|Change From Baseline in Number of Additional Usage of Salbutamol at Week 12|Salbutamol was given as a rescue medicine, used on <= 2 days and at most 4 occasions per week. Change from baseline value was calculated by subtracting the baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Number of occassions||Standard Deviation|Mean
2822683|NCT00363480|Secondary|Change From Baseline in Mean 24-hour Symptom Score at Week 12|The various symptoms like wheezing, shortness of breath, coughing and chest tightness were assessed by the participants every morning using a symptom score scale which ranged from 0 (no symptoms during the past 24 hours) to 5 (symptoms so severe that participant could not go to work or carry out other normal daily activities). Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
2822684|NCT00363480|Secondary|Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12|PEF, a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. The mean morning PEF evaluated by means of the data documented in the asthma diaries. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Percentage||Standard Deviation|Mean
2822685|NCT00363480|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12|FEV1, an amount of air exhaled by a person during a forced breath in one second. FEV1 assessed at Visit 1 and at Visits 3, 4, 5, 6. Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.|Baseline (Visit 3) up to Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Litre/second (L/Sec)||Standard Deviation|Mean
2822686|NCT00363480|Secondary|Correlation of Change in AQLQ Score and Change in ACT Score|Correlation between change in the AQLQ and ACT score was tabulated using the Pearson coefficient of correlation (linear correlation). The AQLQ contained 32 items in 4 domains: activity limitation, symptoms, emotional function and environmental stimuli. Scores for the domains as well as the overall score were scaled within a range of 1 (worst) to 7 (best).|Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||participants|||Number
2822687|NCT00363480|Secondary|Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)|For the level of asthma control, baseline values were derived taking the last 8 weeks during the pre-treatment period prior to Visit 3 into consideration. Regarding derived variables based on the asthma diary, data from the last week prior to Visit 3 was taken. Visit 3, regarded as baseline. AQLQ has 32 questions regarding activities, emotions, symptoms, and environmental triggers. Each item values range from 1 (maximum impairment) to 7 (no impairment). A positive change from baseline score indicates improvement.|Baseline (Visit 3) up to Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
2822688|NCT00363480|Secondary|Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12|Well controlled or totally controlled asthma assessments were done according to the GOAL criteria. A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score >1(Range: 0= None to 5= severe), rescue salbutamol use on <= 2 days and at most 4 occasions per week, and morning peak flow >= 80% of the predicted value on each day per week. All of the criteria which included no night-time awakenings due to asthma (diary entry),no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change were fulfilled. The total ACT score was based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2823084|NCT00360360|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Median
2822689|NCT00363480|Secondary|Change From Baseline in Mean ACT Score at Visit 6|The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. In order to derive the total ACT score, all 5 questions had to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Viait 3) and Week 12|Full Analysis Set. Only those participants available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2822690|NCT00363480|Secondary|Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12|The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. In order to derive the total ACT score, all 5 questions needed to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.|Baseline (Visit 3) and Week 12|Full Analysis Set comprised of all participants with at least one post-baseline (Visit 3) efficacy measurement during clinic visits (Visit 4, 5, 6) or valid diary data documented for at least one week post-baseline was included. Only those participants available at the indicated time points were analyzed.|||Participants|||Number
2822691|NCT00363480|Primary|Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12|A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score >1 (Range: 0= None to 5= severe), rescue salbutamol use on <= 2 days and at most 4 occasions per week, and a morning peak flow >= 80% of the predicted value on each day per week. All of the criteria which includes no night-time awakenings due to asthma (diary entry), no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change are fulfilled. The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control.|Week 9 to Week 12|Modified Intent-to-Treat population, participants covering treatment period of at least 8 weeks and with assessable asthma control at the end of the treatment period by both criteria (GOAL, ACT), and without major protocol deviations. Only those participants available at the indicated time points were analyzed.|||Percentage|||Number
2822692|NCT00363467|Secondary|1 Year Overall Survival|Number of participants alive at 1 year posttransplant|1 year post transplant||||participants|||Number
2822693|NCT00363467|Secondary|1 Year Event-free Survival|Number of participants alive and without disease relapse at 1 year posttransplant|1 year post transplant||||participants|||Number
2822694|NCT00363467|Secondary|Severe Regimen-related Toxicity|Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.|up to 100 days post translant||||participants|||Number
2822695|NCT00363467|Secondary|Successful Autologous Stem Cell Collection|Number of subjects who were able to collect at least 2 million CD34+ cells/kg|At time of stem cell collection|per protocol|||participants|||Number
2822696|NCT00363467|Primary|100-day Non-relapse Mortality|100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease|100 days post transplant|"Analysis was per protocol"|||participants|||Number
2822697|NCT00363415|Post-Hoc|Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes|Number of participants with Low Density Lipoprotein <=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes).|baseline to date of death due to any cause (up to 19.6 months)|Number of randomized participants.|||participants|||Number
2822698|NCT00363415|Secondary|Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)|The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.|baseline to date of death due to any cause (up to 19.6 months)|The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.|||months||95% Confidence Interval|Median
2822699|NCT00363415|Secondary|Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)|FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.|baseline and 6 cycles (21-day cycles)|Number of randomized participants with baseline and non-missing value at respective cycle.|||units on a scale||Standard Deviation|Mean
2822700|NCT00363415|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 14.7 months)|All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.|||months||95% Confidence Interval|Median
2822701|NCT00363415|Secondary|Overall Survival (Subgroups)|The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.|baseline to date of death from any cause (up to 19.6 months)|Number of randomized participants.|||months||95% Confidence Interval|Median
2822702|NCT00363415|Primary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 19.6 months)|Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.|||months||95% Confidence Interval|Median
2822703|NCT00363311|Secondary|Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)|"The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I feel close to my friends., I get emotional support from my family., I get support from my friends., My family has accepted my illness., I am satisfied with family communication about my illness., I feel close to my partner (or the person who is my main support)., I am satisfied with my sex life. The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822704|NCT00363311|Secondary|Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)|"The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I have a lack of energy., I have nausea., Because of my physical condition, I have trouble meeting the needs of my family., I have pain., I am bothered by side effects of treatment., I feel ill., I am forced to spend time in bed. The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822705|NCT00363311|Secondary|Percent Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822706|NCT00363311|Secondary|Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822707|NCT00363311|Secondary|Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822708|NCT00363311|Secondary|Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822709|NCT00363311|Secondary|Total MAX-PC Fear of Recurrence Subscale Score|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822710|NCT00363311|Secondary|Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822743|NCT00363142|Secondary|Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.|Baseline through Week 24|Participants in the ITT-E Population who met the virologic failure definition|||Participants|||Number
2822711|NCT00363311|Secondary|Total MAX-PC Anxiety Subscale Score Related to PSA Testing|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822712|NCT00363311|Secondary|Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822713|NCT00363311|Secondary|Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Month 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.|||points on a scale||Standard Deviation|Mean
2822714|NCT00363311|Secondary|Percent Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.|||percent change||Standard Deviation|Mean
2822715|NCT00363311|Secondary|Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.|||cc||Standard Deviation|Mean
2822716|NCT00363311|Secondary|Prostate Volume (PV) LOCF|"Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.|||cubic centimeters (cc)||Standard Deviation|Mean
2822717|NCT00363311|Secondary|Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage|"All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as No Worsening."|Months 0-18|ITT Population. As the study progressed, participants dropped out of the study.|||biopsies|||Number
2822718|NCT00363311|Secondary|Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.|Baseline|ITT Population|||biopsies|||Number
2822719|NCT00363311|Secondary|Number of Participants With the Indicated Total Gleason Score|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
2822744|NCT00363142|Secondary|Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24|A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population|||Percent change||Full Range|Median
2823085|NCT00360334|Secondary|Severe Hypoglycemic Rate Per 30 Days|Number of severe hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set|||Number of episodes per 30 days||Full Range|Median
2822720|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
2822721|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Year 1.5|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
2822722|NCT00363311|Secondary|Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||millimeters||Standard Deviation|Mean
2822723|NCT00363311|Secondary|Cumulative Length of Cancer Tumor Core|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||millimeters||Standard Deviation|Mean
2822724|NCT00363311|Secondary|Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||percentage of cores||Standard Deviation|Mean
2822725|NCT00363311|Secondary|Mean Percentage of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||percentage of cores||Standard Deviation|Mean
2822726|NCT00363311|Secondary|Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||cores||Standard Deviation|Mean
2822727|NCT00363311|Secondary|Number of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.|||cores||Standard Deviation|Mean
2822728|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Years 0-3|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
2822729|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis|All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.|Baseline to Month 18|ITT Population. As the study progressed, participants dropped out of the study.|||participants|||Number
2822730|NCT00363311|Secondary|Number of Participants With Pathologic Progression|Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.|||participants|||Number
2822731|NCT00363311|Secondary|Number of Participants With Therapeutic Progression|Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.|Year 1.5 and Overall (Years 0-3)|ITT Population|||participants|||Number
2822732|NCT00363311|Primary|Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression|PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.|||participants|||Number
2822733|NCT00363298|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score|"Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as subclinical, though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed remission. A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a responder criterion in clinical trials."|At end of week 5, except 1 d-amphetamine subject rated at end of week 2|Subjects who entered the 4-week double-blind study continuation phase, including a last observation carried forward for the one d-amphetamine subject who dropped out of this phase at the end of study week 2 (end of the first week of the continuation phase) for lack of efficacy.|||units on a scale||Standard Deviation|Mean
2822734|NCT00363298|Primary|Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2|Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).|At end of week 5, except 1 d-amphetamine subject rated at end of week 2|Subjects who met the study continuation phase entry criterion of >20% decrease in Y-BOCS score after 1 week of double-blind study medication, and entered this 4-week double-blind continuation phase|||participants|||Number
2822735|NCT00363246|Primary|Wheelchair-related Falls|Wheelchair-related falls in 1 year follow-up period.|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility.|||participants|||Number
2822736|NCT00363246|Secondary|Injuries From Wheelchair-related Falls|Wheelchair-related falls that resulted in an injury in the one year follow up period|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility. Analyzed for wheelchair-related fall injury during 1-year follow-up period.|||participants|||Number
2822737|NCT00363168|Secondary|Number of Subjects Experiencing Complications Related to Drug or Its Administration|"Potential complications included:~Deterioration of best-corrected visual acuity by 3 or more lines~Development of intraocular inflammation~Development of elevated intraocular pressure~Development of other ocular or systemic adverse effects.~Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function."|12 months after last injection||||participants|||Number
2822738|NCT00363168|Secondary|Fluorescein Leakage on Fluorescein Angiography||12 months|||||||
2822739|NCT00363168|Secondary|Retinal Thickness Measured by Optical Coherence Tomography (OCT)||12 months|||||||
2822740|NCT00363168|Secondary|Retinal Changes on Funduscopy||12 months|||||||
2822741|NCT00363168|Primary|Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.|Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.|12 months||||participants|||Number
2822742|NCT00363142|Secondary|Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24|Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.|Weeks 12 and 24|PK Parameter (Ctau) Population - Participants in the ITT-E Population who underwent PK sampling and had evaluable APV or RTV Ctau data.|||micrograms/mL||95% Confidence Interval|Geometric Mean
2822745|NCT00363142|Secondary|Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24|A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population|||Percent change||Full Range|Median
2822746|NCT00363142|Secondary|Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24|The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.|Baseline through Week 24|Safety Population|||participants|||Number
2822747|NCT00363142|Secondary|Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline through Week 24|Safety Population: all randomized subjects who consumed at least one dose of study drug and was analyzed according to the treatment received.|||participants|||Number
2822748|NCT00363142|Secondary|Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis|A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24|||cells/mm3||Full Range|Median
2822749|NCT00363142|Secondary|Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24|||log10 copies/mL||Standard Deviation|Mean
2822750|NCT00363142|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA <50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population|||Percentage of participants|||Number
2822751|NCT00363142|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA <400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population|||Percentage of participants|||Number
2822752|NCT00363142|Primary|Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24|Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.|Week 24|Intent-to-Treat Exposed (ITT-E) Population. Subjects who received at least one dose of investigational product.|||Percentage of participants|||Number
2822753|NCT00363129|Secondary|Duration of Sensory Peripheral Neuropathy ≥ Grade 2|Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.|6 months post completion of chemotherapy treatment||||days||95% Confidence Interval|Median
2822754|NCT00363129|Secondary|Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2|Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.|6 months post completion of chemotherapy treatment||||days||95% Confidence Interval|Median
2822755|NCT00363129|Secondary|Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment||||percentage of participants|||Number
2822756|NCT00363129|Secondary|Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment||||percentage of patients|||Number
2822757|NCT00363129|Primary|Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2|The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.|6 months post completion of chemotherapy treatment|Participants who received at least one dose of assigned therapy.|||percentage of participants|||Number
2822758|NCT00363077|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
2822791|NCT00362648|Secondary|Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population|||Subjects|||Number
2822759|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
2822760|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
2822761|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.|||subjects|||Number
2822762|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
2822763|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
2822764|NCT00363077|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||fold increase||95% Confidence Interval|Geometric Mean
2822765|NCT00363077|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||subjects|||Number
2822766|NCT00363077|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||subjects|||Number
2822767|NCT00363077|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.|||titers||95% Confidence Interval|Geometric Mean
2822768|NCT00363051|Secondary|Effect of Octreotide Depot on the Trough Concentrations of Everolimus|The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.|Cycle 1 Day 1, Cycle 2 Day 1|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.|||ng/ml||Standard Deviation|Mean
2822792|NCT00362648|Secondary|Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|"Per Protocol Population~*N analyzed for Serotype P1A[8] is 188"|||Subjects|||Number
2822769|NCT00363051|Secondary|Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)|For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.|Cycle 1 Day 15|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included|||ng/ml||Standard Deviation|Mean
2822770|NCT00363051|Secondary|Time to Overall Survival (OS) (Stratum 2)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.~If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.|||months||95% Confidence Interval|Median
2822771|NCT00363051|Secondary|Time to Overall Survival (OS)(Stratum 1)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.~If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.|||months||95% Confidence Interval|Median
2822772|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.~Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.|||Months||95% Confidence Interval|Median
2822773|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.~Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.|||Months||95% Confidence Interval|Median
2822774|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.|||Participants|||Number
2822775|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.|||Participants|||Number
2822776|NCT00363051|Secondary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)|Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.|||percentage of participants||95% Confidence Interval|Number
2822793|NCT00362648|Primary|Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose||At least 14 days following the third vaccination|Per Protocol Population|||Subjects|||Number
2823086|NCT00360334|Secondary|Nocturnal Hypoglycemic Rate Per 30 Days|Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set|||Number of episodes per 30 days||Inter-Quartile Range|Median
2822777|NCT00363051|Secondary|Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):~Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.~Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.~Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.||||||
2822778|NCT00363051|Secondary|Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):~Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.~Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.~Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.|||Months||95% Confidence Interval|Median
2822779|NCT00363051|Primary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.|||percentage of participants||95% Confidence Interval|Number
2822780|NCT00363038|Primary|Average Bruise Change|Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).|Baseline and 2 weeks||||Units on a Scale||Standard Deviation|Mean
2822781|NCT00362882|Secondary|Progression-free Survival @ 6 Months|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months||||percent of participants|||Number
2822782|NCT00362882|Secondary|Disease Control Rate|Disease control rate was defined as the rate of partial response (PR) plus stable disease (SD; for at least 2 cycles).|Up to 4 years||||percentage of participants|||Number
2822783|NCT00362882|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From first day of treatment to time of death due to any cause, up to 4 years||||Months||95% Confidence Interval|Median
2822784|NCT00362882|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 years||||percentage of participants|||Number
2822785|NCT00362817|Secondary|Quality of Life Assessment|To determine the impact of treatment on quality of life.|up to 2 years|Quality of Life Assessment was not done.||||||
2822786|NCT00362817|Secondary|The Incidence and Severity of Centeral Nervous System (CNS) Toxicities|To determine the incidence and severity of CNS toxicity in patients treated with intra-arterial carboplatin and oral temozolomide.|up to 24 weeks||||patients|||Number
2822787|NCT00362817|Secondary|Determine the Cause of Death of Patients After Treatment|To determine the cause of death (i.e., CNS tumor versus systemic disease progression) in patients after treatment.|up to 1 year||||patients|||Number
2822788|NCT00362817|Secondary|Determine the Overall Survival of Patients|From the time of protocol initiation|up to 64 weeks||||weeks||Full Range|Mean
2822789|NCT00362817|Secondary|Analyze Patients Time to Progression|"Responses to treatment was determined by comparing new enhanced MRI scans with those obtained at the previous evaluation (i.e., 2 treatment cycles ago) or with the pre-IA chemotherapy baseline scan, if it is the first follow-up MRI scan during treatment.~MRI is the neuro-imaging modality of choice, since it is more accurate than CT for small tumors, multiple tumors, and tumors in the posterior fossa.58 The methodology used (techniques and equipment) must be identical for all scans. Lesions should be measured as the largest diameter seen on scan and the largest diameter perpendicular to that dimension."|up to 60 weeks||||weeks||Full Range|Mean
2822790|NCT00362817|Primary|Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide|Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a >50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a >25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.|up to 1 year||||percentage of patients with response|||Number
2822794|NCT00362609|Secondary|Half Life|Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.|||hours||Standard Deviation|Mean
2822795|NCT00362609|Secondary|Apparent Oral Clearance (Cl/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.|||L/hr/kg||Standard Deviation|Mean
2822796|NCT00362609|Secondary|Area Under the Concentration-time Curve (AUC)|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.|Baseline to 24 hours post dose on Day 1|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.|||ng*hr/mL||Standard Deviation|Mean
2822797|NCT00362609|Primary|Variance of Oral Bioavailability|Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2.|1 day|Single dose PK Valid-For Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and taken the test article on the date the PK samples were taken). 2 poor metabolizers were excluded from this analysis.|||ratio|||Number
2822798|NCT00362466|Secondary|Best MMR Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.|throughout study|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
2822799|NCT00362466|Secondary|Duration of CCyR and MMR|Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.|Throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.|||months|||Number
2822800|NCT00362466|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.|All treated participants|||events|||Number
2822801|NCT00362466|Secondary|Progression Free Survival (PFS)|PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.|at 36 months|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
2822802|NCT00362466|Secondary|Estimate Time to MMR and CCyR|Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.|throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.|||months|||Number
2822803|NCT00362466|Secondary|CCyR Rates|CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 3, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.|||Participants|||Number
2822804|NCT00362466|Secondary|Major Molecular Response (MMR) Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.|Month 3, Month 6, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
2822805|NCT00362466|Primary|Complete Cytogenetic Response (CCyR) Rate at Month 6|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 6|This analysis was not done. This study was terminated due to insufficient enrollment.|||participants|||Number
2822841|NCT00362375|Other Pre-specified|Number of Male Sex Partners|The number of male sex partners during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up|||Number of sex partners||Standard Deviation|Mean
2822806|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Mental Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline to 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
2822807|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Physical Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline, 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
2822808|NCT00362453|Secondary|Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.|"Self-efficacy is important for individuals to adopt and maintain a program of regular physical activity. The patient rates his/her confidence of being physically active in different types of situations on a 5-item scale with responses ranging from not at all confident to extremely confident. The total score is coputed by calculating the average of all 5 questions. A higher score indicates greater self-efficacy. Higher numbers reported here indicate more improvement from baseline."|baseline to 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
2822809|NCT00362453|Secondary|Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.|The CES-D was used to assess depressive symptoms. It included a 20-item Likert-type scale with scores ranging from 0 to 60. Higher scores indicated greater dysphoria. Negative numbers reported here indicate improvement in condition from baseline. (So -1 indicates a 1-point improvement from baseline.)|baseline to 12, 24, 48 weeks||||units on a scale||95% Confidence Interval|Mean
2822810|NCT00362453|Secondary|Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.|The standing balance test included tandem, semi-tandem, side-by-side, and one-legged stands. Patients were asked to maintain each position for 30 seconds. For each task, the research staff first demonstrated the task, asked the patient if they felt comfortable and ready and then supported the patient while positioning themselves. One point was given if they exceeded 30 seconds and none if they could not or did not attempt the test. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.|||units on a scale||95% Confidence Interval|Mean
2822811|NCT00362453|Secondary|Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.|The 6 minute walk test is a reliable measure of functional exercise capacity. Patients were asked to walk as fast and as far as possible within the 6-minute period and were accompanied by the research staff using a wheel measure that measured distance covered in inches and convereted to yards; higher scores indicated improved state. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 18 patients from Tai chi group was analyzed for 12 week timepoint. Data for 19 patients from the Attention Control group was analyzed at 48 week timepoint.|||yards||95% Confidence Interval|Mean
2822812|NCT00362453|Secondary|Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.|Timed stand tests measure the time taken to complete ten full stands from a sitting position. Patients began the chair stand seated with their arms folded across their chests, then rose to a standing position and sat back down with their back against the back rest of the chair. The test was completed when the patient stood for the tenth repetition. Chair stand time was measured in seconds, with lower scores indicating improved state. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-second improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.|||seconds||95% Confidence Interval|Mean
2822813|NCT00362453|Secondary|Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.|The study physician who was blinded to group assignment completed a global knee pain assessment VAS with scores ranging from 0 to 10cm; 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.|||cm||95% Confidence Interval|Mean
2822814|NCT00362453|Secondary|Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)|Participants completed a self-reported knee-specific global pain VAS with scores ranging from 0 to 10 centimeters (cm); 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks||||cm||95% Confidence Interval|Mean
2822815|NCT00362453|Secondary|Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The WOMAC was administered to the participants at baseline, 12, 24 and 48 weeks. The pain subscale score range was 0-500mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|baseline to 24, 48 weeks|The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.|||mm||95% Confidence Interval|Mean
2822816|NCT00362453|Secondary|Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The stiffness subscale has a score range 0-200mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|baseline to 12, 24, 48 weeks||||mm||95% Confidence Interval|Mean
2822842|NCT00362375|Other Pre-specified|Unprotected Vaginal Sex With Any Male Partner|The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up|||Percent|||Number
2822817|NCT00362453|Secondary|Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The function subscale had a score range 0-1700mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|from baseline to 12, 24, 48 weeks||||mm||95% Confidence Interval|Mean
2822818|NCT00362453|Primary|Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks|WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|between baseline and 12 weeks.|We analyzed the data on an intent-to-treat basis.|||mm||95% Confidence Interval|Mean
2822819|NCT00362440|Secondary|Body Composition (Fat Mass)||At the end of each 3 month intervention||||kg||Standard Error|Mean
2822820|NCT00362440|Secondary|Cholesterol Levels||At the end of each 3 month intervention||||mg/dl||Standard Error|Mean
2822821|NCT00362440|Primary|Insulin Resistance (HOMA Index)||At the end of each 3 month intervention||||units on a scale||Standard Error|Mean
2822822|NCT00362414|Secondary|Trail Making B Test|Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo.||||correct connections||Full Range|Median
2822823|NCT00362414|Secondary|Trail Making A Test|Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo||||correct connections||Full Range|Median
2822824|NCT00362414|Secondary|Infarct Volume Using Anatomical MRI|Measurement of infarct volume and percent change from baseline to Day 90.|3 mo||||percent change||Standard Error|Mean
2822825|NCT00362414|Secondary|Barthel Index|Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.|3 mo||||Units on a scale||Full Range|Median
2822826|NCT00362414|Secondary|Geriatric Depression Scale Short Form|Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.|3 mo||||Units on a scale||Full Range|Median
2822827|NCT00362414|Secondary|NIH Stroke Scale|Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.|3 mo||||Units on a scale||Full Range|Median
2822828|NCT00362414|Secondary|Line Cancellation Test|Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.|3 mo||||ratio of canceled lines on each side||Full Range|Median
2822829|NCT00362414|Secondary|Boston Naming Test|Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.|3 mo||||Units on a scale||Full Range|Median
2822830|NCT00362414|Secondary|Fugl-Meyer Leg Scale|"Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered normal."|3 mo.||||Units on a scale||Full Range|Median
2822831|NCT00362414|Secondary|Fugl-Meyer Arm Scale|"Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered normal with no impairments."|3 mo||||Units on a scale||Full Range|Median
2822832|NCT00362414|Secondary|Action Research Arm Test|"The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered normal."|3 mo|This number (9) is the total # subjects who could complete the test at all study time points; some subjects were unable to complete this test at one of the time points, especially the acute stroke assessment.|||Units on a scale||Full Range|Median
2822833|NCT00362414|Primary|Mortality|attributable to experimental intervention|3 mo||||participants|||Number
2822834|NCT00362414|Primary|Morbidity|attributable to experimental intervention|3 mo||||participants|||Number
2822835|NCT00362414|Primary|Safety|Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.|3 mo||||participants|||Number
2822836|NCT00362401|Primary|Intensity (Highness) of the Sound From Mechanical Heart Valves|The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient's chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.|10.06.2007|Patients with a mechanical heart valve prosthesis recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.|||dB (decibel)||Standard Deviation|Mean
2822837|NCT00362375|Secondary|Knowledge of HIV Test||current|||||||
2822838|NCT00362375|Secondary|Condom Use Self-efficacy||current|||||||
2822839|NCT00362375|Secondary|HIV Knowledge||current|||||||
2822840|NCT00362375|Secondary|HIV Testing and Receipt of Results|Percentage of women who reported testing for HIV infection and received their test results during the past 3 months|Past 3 months|Based on the number of women who provided data at the 3-month follow-up|||Percent|||Number
2822845|NCT00362336|Secondary|Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post-booster vaccination|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
2822846|NCT00362336|Secondary|Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.|Day 0 up to Day 7 post each dose|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population.|||Participants|||Number
2822847|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 540 pre-booster and Day 570, post-booster|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2822848|NCT00362336|Secondary|Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.|Day 540 pre-booster and Day 570 post-booster|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2822849|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 42 before Dose 1 and 1 month post-Dose 3|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
2822850|NCT00362336|Secondary|Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2822851|NCT00362336|Primary|Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
2822852|NCT00362297|Secondary|Number of Herpes Recurrences, Defined Clinically as >=1 Successive Day on Which Genital Lesions Are Present, in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks|||||||
2822855|NCT00362297|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.|Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression. Shedding rates were calculated by dividing the number of positive swabs by the total number of swabs for each intervention group.|15 weeks|Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis.|||percentage of swabs with HSV detected|Swabs||Number
2822856|NCT00362232|Secondary|Treatment-emergent Major Bleedings Per Safety Population.|Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)|from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).|The safety population comprised those subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
2822857|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
2822858|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
2822859|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
2822860|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
2822861|NCT00362232|Secondary|The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions|Up to 47 days after surgery|The net clinical benefit population comprised all subjects either valid for MITT analysis of major VTE or who showed treatment-emergent major bleeding.|||percentage of participants|||Number
2822862|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
2822863|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
2822864|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
2823087|NCT00360334|Secondary|Hypoglycemic Rate Per 30 Days|Number of hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set|||Number of episodes per 30 days||Inter-Quartile Range|Median
2823088|NCT00360334|Secondary|Incidence of Severe Hypoglycemic Episodes|Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study|26 weeks|Full Analysis Set|||percent|||Number
2822865|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
2822866|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
2822867|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations|||percentage of participants|||Number
2822868|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||percentage of participants|||Number
2822869|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.|||percentage of participants|||Number
2822870|NCT00362232|Primary|Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism|||Percentage of participants|||Number
2822871|NCT00362232|Primary|Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The primary efficacy analysis was based on the per protocol (PP) population and included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.|||Percentage of participants|||Number
2822872|NCT00362180|Secondary|Percent Change in Total Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.|||percent change||Inter-Quartile Range|Median
2822873|NCT00362180|Secondary|Baseline Total Cholesterol|Samples were taken following an overnight fast.|Baseline|Full analysis set|||mg/wk||Inter-Quartile Range|Median
2822874|NCT00362180|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.|||percent change||Inter-Quartile Range|Median
2822875|NCT00362180|Secondary|Baseline Low-Density Lipoprotein Cholesterol|Samples were taken following overnight fast.|Baseline|Full analysis set|||mg/wk||Inter-Quartile Range|Median
2822876|NCT00362180|Secondary|Percent Change in Apolipoprotein B From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.|||percent change||Inter-Quartile Range|Median
2822877|NCT00362180|Secondary|Baseline Apolipoprotein B|Samples were taken following an overnight fast.|Baseline|Full analysis set|||mg/wk||Inter-Quartile Range|Median
2822890|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822878|NCT00362180|Primary|Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)|Localized proton MRS was used to quantify liver TG concentration. All MRS imaging of the liver was performed using the same 1.5T scanner. The instructions were to cover the entire liver (from just above the dome to just below the inferior tip) using a qualified imaging technique (Yokoo, 2009, Radiology). Liver fat quantification was performed by determining the liver fat fraction (%) derived from MRS using selected Regions of Interest (ROI). The analyst typically looked for the branching of the right portal vein and mapped slices from one scan to the next. There were typically 2 ROIs in the right lobe and 1 in the left lobe. Magnetic resonance spectroscopy imaging ROIs between different scans were selected using anatomical landmarks for both time points.|Baseline, Day 26, Day 99|Full analysis set. In Cohort E: Placebo, Day 99 N=11 instead of 10 because participant did not have a post treatment MRS by Day 26.|||percentage of total liver content||Full Range|Median
2822879|NCT00362128|Primary|Number of Participants With Hypertension|Systolic BP above 129 or Diastolic BP above 79.|4 years||||participants|||Number
2822880|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822881|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822882|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822883|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822884|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822885|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822886|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822887|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822888|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822889|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822930|NCT00361439|Secondary|Change From Baseline in Percentage of Eosinophils at 2 Weeks|"A decrease between visits signifies a reduction in inflammation.~Calculated from cytology specimens obtained by lavage."|baseline and 2 weeks||||percentage of eosinophils||Full Range|Median
2822891|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822892|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822893|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822894|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822895|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
2822896|NCT00362115|Secondary|Change From Baseline in Standing Clinic Diastolic Blood Pressure.|The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2822897|NCT00362115|Secondary|Change From Baseline in Standing Clinic Systolic Blood Pressure.|The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2822898|NCT00362115|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure.|The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2822899|NCT00362115|Primary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure.|The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2822900|NCT00361972|Secondary|Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement|Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.|Baseline and 6 weeks||||log (pg/mL)||Inter-Quartile Range|Median
2822901|NCT00361972|Primary|Change in Lymphocyte Count|Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.|Baseline and 6 weeks||||Lymphocytes per square millimeter||Standard Deviation|Mean
2822902|NCT00361712|Primary|Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth|Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery|At birth of parturients||||pg/ml||Standard Deviation|Mean
2822903|NCT00361712|Primary|Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery|Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery|24 hours after delivery||||pg/ml||Standard Deviation|Mean
2822904|NCT00361712|Primary|Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment|Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment|Right after enrollment||||pg/ml||Standard Deviation|Mean
2822905|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 85|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 85 and from Day -28 to Day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
2822906|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 57|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 57 and from Day -28 to Day 1|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
2822931|NCT00361439|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks|An increase between visits indicates improved nasal airflow.|baseline and 2 weeks||||liters per minute||Full Range|Median
2823089|NCT00360334|Secondary|Incidence of Nocturnal Hypoglycemic Episodes|Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set|||percent|||Number
2822907|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 29|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 29 and from Day -28 to Day 1|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
2822908|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 85|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 85 and from study day -28 to study day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
2822909|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 57|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 57 and from study day -28 to study day 1.|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
2822910|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 29|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 29 and from study day -28 to study day 1.|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||percent change||Standard Deviation|Mean
2822911|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-85|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822912|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-57|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822913|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Time Curve (IAUC) From Days 1-85|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822914|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Tme Curve (IAUC) From Days 1-57|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822915|NCT00361634|Primary|Percent Change in Synovial Initial Area Under the (Contrast-time) Curve (IAUC) From Days 1-29|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822916|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-85|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 85. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, increases in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822932|NCT00361439|Secondary|Change From Baseline in Total Nasal Symptom Score at 2 Weeks|A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.|baseline and 2 weeks||||units on a scale||Full Range|Median
2822917|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-57|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 57. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822918|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-29|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822919|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 29. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available Day 29 data are included in the analysis.|||Percent change||Standard Deviation|Mean
2822920|NCT00361595|Secondary|Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months||||mcg/ml||Standard Deviation|Mean
2822921|NCT00361595|Secondary|Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months||||ng/ml||Standard Deviation|Mean
2822922|NCT00361595|Secondary|Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months|Change in bone density (grams/cm^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.|6 months and 12 months||||grams/cm^2||Standard Deviation|Mean
2822923|NCT00361595|Primary|Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)||Baseline and 12 months||||grams/cm^2||Standard Deviation|Mean
2822924|NCT00361569|Secondary|Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)|Any adverse event reported from the beginning of the 28-day screening through the subject's last report.|Up to Week 12|All randomized subjects who received at least one dose of study medication|||Participants|||Number
2822925|NCT00361569|Primary|Mean Change in Maturation Index|Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints|||Index||Standard Error|Least Squares Mean
2822926|NCT00361569|Primary|Mean Change in Vaginal pH|Change= Week 12 vaginal pH - Baseline vaginal pH|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints|||pH||Standard Error|Least Squares Mean
2822927|NCT00361569|Primary|Mean Change in the Symptom Identified by the Patient to be Most Bothersome|Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.|Baseline to Week 12|Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints|||Scores on a scale||Standard Error|Least Squares Mean
2822928|NCT00361504|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52."|Baseline, Week 52|intent-to-treat|||Scores on a Scale||Standard Deviation|Mean
2822929|NCT00361504|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized participants who took at least one dose of study medication).|||Participants|||Number
2822934|NCT00361374|Primary|Score on a Depression Severity Rating Scale Over Eight Weeks|Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.|8 weeks|We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects|||units on a scale||Standard Error|Mean
2822935|NCT00361335|Secondary|Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14|The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.|Weeks 0 to Week 14|Intent to treat (ITT). Missing components were imputed by the median component value of all patients in the same Stratum at baseline, and last observation carried forward (LOCF) at Week 14|||Units on a scale||Standard Deviation|Mean
2822936|NCT00361335|Secondary|Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A Moderate response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2"|Week 0 to Week 14|Intent to treat. Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing components were imputed by the median component value of all patients in the same stratum unless all components are missing in which case considered non-responders.|||Participants|||Number
2822937|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
2822938|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).|Week 0 to Week 24||||Participants|||Number
2822939|NCT00361335|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14|An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
2822940|NCT00361296|Secondary|Combined Immune and Clinical Response Rate|Number of participants who exhibited both an immune response as defined by Outcome 3 and a hematologic or cytogenetic response as defined by Outcomes 1 and 2, respectively.|Week 21 post-intervention||||Participants|||Count of Participants
2822941|NCT00361296|Secondary|Immune Response Rate as Assessed by Number of Participants Who Exhibit Induced Immune Response to WT-1, Survivin, or Proteinase-3|Immune response to WT-1, survivin, or proteinase-3 as defined by a 30% increase from baseline in cytotoxic T cells measured by Elispot analysis.|Baseline, week 21 post-intervention||||Participants|||Count of Participants
2822942|NCT00361296|Primary|Cytogenetic Response Rate as Assessed by Number of Participants Achieving a Cytogenetic Response|Cytogenetic response is defined as normalization of pretreatment cytogenetic abnormalities.|Week 21||||Participants|||Count of Participants
2822943|NCT00361296|Primary|Hematologic Response Rate as Assessed by Number of Participants Achieving a Major Hematologic Response|A major hematologic response is defined as any of the following: hemoglobin increase >= 2 g/dL from baseline; platelet increase >= 30k/mcL from baseline; or neutrophil increase >= 100% or >= 500/mcL from baseline.|Baseline, week 21 post-intervention||||Participants|||Count of Participants
2822944|NCT00361283|Primary|Mean Change in Level: Week 16-baseline in Ena-78|We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.|16 weeks after baseline|Power calculation|||pg/ml||Standard Deviation|Mean
2822945|NCT00361270|Secondary|Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)|The change score is the difference between pre-treatment scores on the Pittsburgh Sleep Quality Index (PSQI) and the 1-week post-treatment scores. Positive values indicate a reduction in sleep problems. The PSQI was scored on 19 items with 7 component scores ranging from 0 no difficulty falling asleep to 3 severe difficulty, then component scores added to create global score ranging from 0 no difficulty falling asleep to 21 severe difficulty falling asleep.|Subjects change on this scale from Pre-treatment to 1-week post treatment||||units on a scale||Standard Deviation|Mean
2822946|NCT00361270|Secondary|Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale|The change score measures the difference between pre-treatment scores on the Brief Pain Inventory-Interference Scale (NRS: 0 no interference - 10 complete interference) and 1- week post treatment scores for the 10 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1-week post treatment||||units on a scale||Standard Deviation|Mean
2822947|NCT00361270|Primary|Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale|The change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1 week post treatment||||units on a scale||Standard Deviation|Mean
2822948|NCT00361257|Secondary|Changes in Alternate Frontal Systems Z-Score|The alternate frontal systems was defined as a mean of age and education adjusted z score of Interference task, and age, sex, education, and African-American ethnicity adjusted z score of Trail Making Part B. The outcome was the 24 week change in alternate frontal systems z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822949|NCT00361257|Secondary|Changes in Alternate Verbal Memory Z-Score|The alternate verbal memory was defined as a mean of age and education adjusted z score of trials 1 to 3 and delayed recall tests. The outcome is the 24 week change in alternate verbal memory z-score (week 24-baseline).|At baseline and week 24|The analysis is based on observed data.|||z-score||Standard Deviation|Mean
2822950|NCT00361257|Secondary|Changes in Alternate Psychomotor Function Z-Score|The alternate psychomotor function is defined as the mean of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA), and age and education adjusted z score of Symbol Digit (SYD). The outcome is the 24 week change in alternate psychomotor function z-score (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.|||z-score||Standard Deviation|Mean
2822951|NCT00361257|Secondary|Changes in Neurotransmitter Levels (Unit = uM Only)|Neurotransmitter levels (Glutamate, Tryptophan, Anthranilic Acid, Quinolinic Acid, Kynurenin, and 3-Hydroxykynurenine). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||uM||Inter-Quartile Range|Median
2822952|NCT00361257|Secondary|Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)|Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||Pixels/mm^2||Inter-Quartile Range|Median
2822953|NCT00361257|Secondary|Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)|Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||pg/mL||Inter-Quartile Range|Median
2822954|NCT00361257|Secondary|Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)|Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.|||counts per second||Inter-Quartile Range|Median
2822955|NCT00361257|Secondary|Changes in Medication Management Test (Modified)|The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It's the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management.|At baseline and weeks 24|The analysis was based on observed data.|||scores on a scale||Standard Deviation|Mean
2822956|NCT00361257|Secondary|Changes in Instrumental Activities of Daily Living Questionnaire|The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline.|At baseline and week 24|The analysis was based on observed data.|||participants|||Number
2822957|NCT00361257|Secondary|Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load|The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (<30 copies/mL and >= 30 copies/mL).|At baseline and week 24|The summary statistics were based on observed data. No statistical analysis was conducted.|||participants|||Number
2822958|NCT00361257|Secondary|Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms|Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section.|Throughout study up to week 48|The analysis includes all randomized participants. A total of 37 minocycline and 38 placebo participants reported Grade 2 or higher toxicity and/or signs and symptoms during 48 weeks.|||participants with an event|||Number
2822959|NCT00361257|Secondary|Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)|The outcome was the 24 week change of CD8 cell counts (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||cells/mm^3||Standard Deviation|Mean
2822961|NCT00361257|Secondary|Change in Karnofsky Performance Score|"The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks.~For the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created."|At baseline and week 24|The analysis was based on observed data.|||participants|||Number
2822962|NCT00361257|Secondary|Change in Frontal Systems Function Domain Z-Score|The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822963|NCT00361257|Secondary|Change in Verbal Memory Domain Z-Score|The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822964|NCT00361257|Secondary|Change in Information Processing Function Domain Z-Score|The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822965|NCT00361257|Secondary|Change in Fine Motor/Nonverbal Function Domain Z-Score|The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822966|NCT00361257|Secondary|Change in Psychomotor Function Domain Z-Score|The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822967|NCT00361257|Secondary|Change in Fine Motor Function Domain Z-Score|The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.|||z-score||Standard Deviation|Mean
2822968|NCT00361257|Secondary|Change in Cognitive Gross Motor Function Domain Z-Score|The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.|||z-score||Standard Deviation|Mean
2822969|NCT00361257|Secondary|Change in Investigator's Clinical Global Impression Score (ICGIS)|"Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening.~For the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved."|At week 24|The analysis was based on observed data.|||participants|||Number
2822970|NCT00361257|Secondary|Change in Global Deficit Z-Score (GDS)|GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline).|At baseline and week 24|The analysis was based on the observed data.|||z-score||Standard Deviation|Mean
2822971|NCT00361257|Primary|Change in Cognitive Performance Compared to Baseline|"Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are:~Grooved Pegboard Dominant Hand (GPD)~Grooved Pegboard Non-dominant hand (GPN)~Choice Reaction Time (CRT)~Sequential Reaction Time (QRT)~Timed Gait (TIG)~Trail Making Part A (TMA)~Trail Making Part B (TMB)~Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline."|At baseline and week 24|The descriptive statistics above were based on the observed data; however, the statistical analysis was conducted by the ITT analysis and the missing outcomes at week 24 were imputed based on multiple regression imputations.|||z-score||Standard Deviation|Mean
2822972|NCT00361231|Secondary|Overall Response Rate|To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||percentage of participants|||Number
2822973|NCT00361231|Primary|Median Progression Free Survival|To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.|2 years||||months||95% Confidence Interval|Median
2823010|NCT00360698|Primary|Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%|Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|at the end of treatment (week 24)|Modified Intent to treat (ITT) population, LOCF (Last Observation Carried Forward)|||percentage of participants|||Number
2823011|NCT00360685|Secondary|Overall Survival|number of participants alive at one year|1 year|intent to treat|||participants|||Number
2822974|NCT00361218|Primary|Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response|"Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation.~Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression)."|8 weeks|QEEG data were collected, analyzed and reported as part of a larger trial. The analysis of QEEG data per protocol was only possible using the proprietary algorithm developed by a company; acquisition of that company precludes analysis for this study alone. Larger study reported in: Iosifescu DV et al. Eur Neuropsychopharmacol. 2009;19:772-7.||||||
2822975|NCT00361218|Primary|Serum Brain-derived Neurotrophic Factor (BDNF) Levels|"Pre-SSRI BDNF Level refers to the data collection point before SSRI intake and Post-SSRI BDNF Level refers to the data collection point 8 weeks after SSRI intake."|8 weeks||||pg/mL||Standard Deviation|Mean
2822976|NCT00361140|Primary|Non-relapse Mortality|The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.|100 days|Intent to treat|||participants|||Number
2822977|NCT00361140|Secondary|Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)|The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant.|100 days|Intent to treat|||participants|||Number
2822978|NCT00360971|Secondary|Time to Second Primary Tumor|An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.|From randomization to maximum follow-up at time of analysis of 21 months|Randomized patients who started protocol treatment|||Participants|||Count of Participants
2822979|NCT00360971|Secondary|Progression-free Survival|An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.|From randomization to maximum follow-up at time of analysis of 21 months|Randomized patients who started protocol treatment|||Participants|||Count of Participants
2822980|NCT00360971|Secondary|Overall Survival|An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported.|From randomization to maximum follow-up at time of analysis of 21 months|Randomized patients who started protocol treatment|||Participants|||Count of Participants
2822981|NCT00360971|Secondary|Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Twice-weekly from start of treatment up to 15 weeks after the start of treatment.|All randomized patients|||days||Standard Deviation|Mean
2822982|NCT00360971|Secondary|Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Twice-weekly from start of treatment up to 15 weeks after the start of treatment.|All randomized patients|||Participants|||Count of Participants
2822983|NCT00360971|Primary|Duration of Oral Mucositis as Measured in Terms of Days|"Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.~This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.~Statistical testing was not done due to the small sample size."|Twice-weekly from start of treatment up to 15 weeks after the start of treatment.|All eligible patients.|||Days||Standard Deviation|Mean
2822984|NCT00360828|Secondary|Overall Survival at 12 Months|Patients surviving 12 months after last dose of drug|12 months post treatment end|All participants who received at least one dose of drug|||participants|||Number
2822985|NCT00360828|Secondary|Frequency and Severity of Toxicity|Toxicities assessed through 3 months|3 months|The low accrual rate prevented us from completing the planned analysis.||||||
2822986|NCT00360828|Secondary|Progression Free Survival|Patients surviving at one year post treatment end|1 year post treatment end|The low accrual rate prevented us from completing the planned analysis.||||||
2822987|NCT00360828|Secondary|Overall Survival at 6 Months|Patients surviving 6 months after treatment end|6 months post treatment end|All participants who received at least one dose of drug|||participants|||Number
2822988|NCT00360828|Primary|Number of Participants With Objective Response After 3 Cycles of Treatment|The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.|3 cycles (21 day cycles)|All participants having stable disease|||participants|||Number
2822989|NCT00360724|Other Pre-specified|Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)|To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.|Follow up||||percentage of connecting nods||Standard Deviation|Mean
2823012|NCT00360685|Secondary|Incidence of Acute Graft-vs-host Disease (aGVHD)|incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation|100 days post transplant|intent to treat|||participants|||Number
2822991|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information"|Baseline|subjects for whom post-baseline data were available|||points on rating scale||Standard Deviation|Mean
2822992|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|Baseline|subjects for whom post-baseline data was available|||Scores on a scale||Standard Deviation|Mean
2822993|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression"|Baseline|subjects for whom data post baseline were available|||Scores on a scale||Standard Deviation|Mean
2822994|NCT00360724|Secondary|Clinical Global Impressions Improvement(CGI-I)|"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.~0 = Not assessed~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse Higher score=greatest worsening"|10 weeks|subjects for whom post-baseline data was available|||Scores on a scale||Standard Deviation|Mean
2822995|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|Week 10|subjects fro whom post-baseline data was available|||Scores on a scale||Standard Deviation|Mean
2822996|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information"|Week 10|subjects for whom post-baseline data were available|||points on rating scale||Standard Deviation|Mean
2822997|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression"|Week 10|subjects for whom data post baseline were available|||scores on a scale||Standard Deviation|Mean
2822998|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.|||Scores on a scale||Standard Deviation|Mean
2822999|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 10|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.|||Scores on a scale||Standard Deviation|Mean
2823000|NCT00360698|Secondary|Rate of Severe Symptomatic Hypoglycemia||during treatment period (12 weeks)|Safety population|||Number of hypoglycemia per patient-year||Standard Deviation|Mean
2823001|NCT00360698|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population|||Number of hypoglycemia per patient-year||Standard Deviation|Mean
2823002|NCT00360698|Secondary|Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population|||Number of hypoglycemia per patient-year||Standard Deviation|Mean
2823003|NCT00360698|Secondary|Daily Dose of Insulin Glulisine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF|||units of insulin glulisine per day||Standard Deviation|Mean
2823004|NCT00360698|Secondary|Daily Dose of Insulin Glargine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF|||units of insulin glargine per day||Standard Deviation|Mean
2823005|NCT00360698|Secondary|Change in Weight||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF|||kg||Standard Error|Least Squares Mean
2823006|NCT00360698|Secondary|Change in Daily Mean Plasma Glucose||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF|||mg/dL||Standard Error|Least Squares Mean
2823013|NCT00360685|Primary|Incidence of Severe Mucositis|Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.|2 year|Intent to treat|||participants|||Number
2823014|NCT00360672|Primary|Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses)|Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.|Following three 28-day cycles evaluated for response||||participants|||Number
2823015|NCT00360568|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (Month 12 months or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823016|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823017|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823018|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823019|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823020|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823028|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823021|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823022|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823023|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823024|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823025|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823026|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823027|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823090|NCT00360334|Secondary|Incidence of Hypoglycemic Episodes|Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set|||percent|||Number
2823091|NCT00360334|Secondary|Change in Apolipoprotein-B|Change in apolipoprotein-B from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward|||g/L||Standard Error|Least Squares Mean
2823029|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823030|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823031|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823032|NCT00360568|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment; n=number of participants with assessment at timepoint.|||units on a scale||Standard Deviation|Mean
2823033|NCT00360568|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Month 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Deviation|Mean
2823034|NCT00360568|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Deviation|Mean
2823035|NCT00360568|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Deviation|Mean
2823036|NCT00360568|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
2823037|NCT00360568|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS) Findings|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187-3-3003 LCIG infusion with a C-SSRS assessment during the study.|||participants|||Number
2823038|NCT00360568|Primary|Number of Participants With Clinically Significant Neurological Examination Findings|"The neurologic examination was to be done during On time. The neurological examination assessed: cranial nerves - assessment of cranial nerves II - XII, excluding fundoscopic examination; motor system - assessment of tone, strength, and abnormal movements; sensory system - including light touch, pinprick, joint position, and vibratory sense; reflexes - assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination - assessment of upper and lower extremities; gait - assessment of base and tandem gait; station - assessment of posture and stability."|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had a neurological examination.|||participants|||Number
2823039|NCT00360568|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|up to Month 12|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
2823040|NCT00360568|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.|||units on a scale||Standard Deviation|Mean
2823041|NCT00360568|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, Post-baseline (up to Month 12)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.|||participants|||Number
2823042|NCT00360568|Primary|Number of Participants With Sleep Attacks at Baseline and Endpoint|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
2823043|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
2823044|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment.|||participants|||Number
2823045|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with an assessment.|||participants|||Number
2823046|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f) and males (m).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had an assessment.|||participants|||Number
2823047|NCT00360568|Primary|Number of Participants With Device Complications|Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
2823048|NCT00360568|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.|||participants|||Number
2823049|NCT00360555|Primary|Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit. Potential responses included no, low, moderate, or strong and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:~0 = No desire~= Low desire~= Moderate desire~= Strong desire"|baseline to 24 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.|||units on a scale||Standard Error|Least Squares Mean
2823050|NCT00360555|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.|"For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.~For satisfying sexual events:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)"|baseline to 28 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.|||SSEs per 28 days||Standard Deviation|Mean
2823051|NCT00360529|Secondary|Patient Benefit Evaluation|"The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question (Overall, do you believe that you have experienced a meaningful benefit from the study medication?) was asked upon treatment discontinuation."|Week 24|This question was asked at Week 24 only, so did not include participants who had discontinued the trial prior to that time (e.g., analysis population includes treatment completers only).|||participants|||Number
2823052|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit|The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from '0' to '5.' The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
2823053|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit|Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
2823054|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit|Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
2823055|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit|"Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period.~The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is '52' (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||score on a scale||Standard Error|Least Squares Mean
2823070|NCT00360490|Secondary|Percent Change From Baseline MBL to End of Study MBL (Cycle 6)|The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||Percent change||Standard Deviation|Mean
2823071|NCT00360490|Primary|Percentage of Patients With Successful Treatment|End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.|At 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||Percentage of participants|||Number
2823056|NCT00360529|Primary|Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit|"Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours/since your last visit. Potential responses included no, low, moderate, or strong, scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire):~0 = No desire~= Low desire~= Moderate desire~= Strong desire~Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Least Squares Mean
2823057|NCT00360529|Primary|Satisfying Sexual Event Monthly Change From Baseline at Final Visit|Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||number of events||Standard Deviation|Mean
2823058|NCT00360490|Secondary|Percentage of Patients With Improvement in the Patients Overall Assessment Scale|"Improved is classified as 'very much improved', 'much improved', or 'improved' and not improved is classified as 'no change', 'worse', 'much worse', or 'very much worse'."|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.|||percentage|||Number
2823059|NCT00360490|Secondary|Percentage of Patients With Improvement in the Investigator Global Assessment Scale|"Improved is classified as 'very much improved', 'much improved', or 'improved' and not improved is classified as 'no change', 'worse', 'much worse', or 'very much worse'"|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.|||percentage|||Number
2823060|NCT00360490|Secondary|Percent Change in Serum Ferritin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 148 subjects (75 for LNG IUS and 73 for MPA) were available for the analysis.|||percent change||Full Range|Median
2823061|NCT00360490|Secondary|Percent Change in Hematocrit||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.|||percent change||Full Range|Median
2823062|NCT00360490|Secondary|Percent Change in Hemoglobin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.|||percent change||Full Range|Median
2823063|NCT00360490|Secondary|Total Number of Bleeding Episodes|A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||number of bleeding episodes||Standard Deviation|Mean
2823064|NCT00360490|Secondary|Total Number of Spotting Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||days||Standard Deviation|Mean
2823065|NCT00360490|Secondary|Total Number of Spotting and Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||days||Standard Deviation|Mean
2823066|NCT00360490|Secondary|Total Number of Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.|||days||Standard Deviation|Mean
2823067|NCT00360490|Secondary|Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis.|||percentage of participants|||Number
2823068|NCT00360490|Secondary|Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)|The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||Percent change||Standard Deviation|Mean
2823069|NCT00360490|Secondary|Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||milliliter (mL)||Full Range|Median
2823072|NCT00360490|Primary|The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.|||milliliter (mL)||Full Range|Median
2823073|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population|||Scores on a scale||Standard Deviation|Mean
2823074|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population|||Scores on a scale||Standard Deviation|Mean
2823075|NCT00360412|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population|||Hours||Standard Deviation|Mean
2823076|NCT00360412|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel|||Hours||Standard Deviation|Mean
2823077|NCT00360399|Secondary|Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy|The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks|Measured after 12 weeks of combined treatment|Participants who did not achieve remission during monotherapy were offered 12 weeks of combination therapy. This sample consists of those participants who consented for the combination therapy part of the trial and who completed the 12 weeks of treatment.|||participants|||Number
2823078|NCT00360399|Secondary|Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment|The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.|Measured at 6, 9, 12, 15, 18, 21, and 24 months|This population is comprised of participants who completed 12 weeks of treatment, achieved remission, and participated in a follow-up phase that lasted for up to 21 months or until recurrence occurred.|||participants|||Number
2823079|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7"|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.|||participants|||Number
2823080|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7"|Up to 12 Weeks|The population is defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment.|||participants|||Number
2823081|NCT00360399|Primary|Remission From Major Depressive Episode Among Participants Who Completed the Intervention|The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.|||percentage of participants|||Number
2823082|NCT00360399|Primary|Remission From Major Depressive Episode in Intent to Treat Sample|The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.|Up to 12 Weeks|This population consists of all participants who were randomized and returned for at least one study visit. This population was used for the intent to treat analyses and not all of these individuals completed the study.|||percentage of participants|||Number
2823099|NCT00360334|Secondary|Percent of Patients Achieving 10% Weight Loss|Percent of patients who lost at least 10% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.|||Percentage of participants|||Number
2823100|NCT00360334|Secondary|Percent of Patients Achieving 5% Weight Loss|Percent of patients who lost at least 5% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.|||Percentage of participants|||Number
2823101|NCT00360334|Secondary|Percent Change in Body Weight|Percent change in baseline body weight at endpoint|26 Weeks|Full Analysis Set|||Percentage||Standard Error|Least Squares Mean
2823102|NCT00360334|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint|26 weeks|Full Analysis Set|||kg||Standard Error|Least Squares Mean
2823103|NCT00360334|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint|26 weeks|Full Analysis Set|||Ratio||Standard Error|Least Squares Mean
2823104|NCT00360334|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint|26 Weeks|Full Analysis Set|||cm||Standard Error|Least Squares Mean
2823105|NCT00360334|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline to endpoint|26 weeks|Full Analysis Set|||kg/m^2||Standard Error|Least Squares Mean
2823106|NCT00360334|Secondary|Change in 7 Point Self Monitored Blood Glucose Profile|Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Deviation|Mean
2823107|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 6.5%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.|||Percentage of participants|||Number
2823108|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 7%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.|||Percentage of participants|||Number
2823109|NCT00360334|Secondary|Percent of Patients Achieving HbA1c ≤ 7.4%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.|||Percentage of participants|||Number
2823110|NCT00360334|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)|26 weeks|Full Analysis Set, Last Observation Carried Forward|||mmol/L||Standard Error|Least Squares Mean
2823111|NCT00360334|Secondary|Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.|||Percentage of participants|||Number
2823112|NCT00360334|Primary|Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.|||percentage of participants|||Number
2823113|NCT00360308|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population|||Hours||95% Confidence Interval|Least Squares Mean
2823114|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823115|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823116|NCT00360308|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.|||Hours||95% Confidence Interval|Least Squares Mean
2823191|NCT00359788|Secondary|Morning PEFR at Week 7|Weekly means for morning PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823117|NCT00360282|Secondary|Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus|Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.|Pre and Post Stimulus (6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.|||units on a scale||Inter-Quartile Range|Median
2823118|NCT00360282|Primary|Change From Baseline in Motion Sickness to Post Vestibular Stimulus|Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.|Pre and Post Stimulus (about 6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.|||units on a scale||Inter-Quartile Range|Median
2823119|NCT00360269|Secondary|Clinical Global Impression, Improvement Scale|The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|12 weeks||||Units on a scale||Standard Deviation|Mean
2823120|NCT00360269|Secondary|Wender-Reimherr Adult Attention Deficit Disorder Scale|The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0-2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF).|Baseline and Week 12||||Units on a scale||Standard Deviation|Mean
2823121|NCT00360269|Secondary|Urine Drug Screens|Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.|12 weeks||||Percentage of positive UDS|||Number
2823122|NCT00360269|Primary|Estimated Week 12 Self-reported Use|Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.|One week (study week 12)||||Times per day||Standard Error|Mean
2823123|NCT00360269|Secondary|Self-reported Longitudinal Use|Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back.|12 weeks||||Percentage of days used||Standard Deviation|Mean
2823124|NCT00360243|Primary|Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit. Potential responses included no, low, moderate, or strong and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:~0 = No desire~= Low desire~= Moderate desire~= Strong desire"|baseline to 24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Least Squares Mean
2823125|NCT00360243|Primary|Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.|||SSEs per week||Standard Deviation|Mean
2823126|NCT00360230|Secondary|Titers for Anti-Hepatitis B (Anti-HBs)|Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).|At Day 0 and at Month 2|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2823127|NCT00360230|Secondary|Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)|Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Day 0, at Month 2, at Month 7 and at Month 10|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2823138|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Confused State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823128|NCT00360230|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.|||Participants|||Count of Participants
2823129|NCT00360230|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2823130|NCT00360230|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2823131|NCT00360230|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 10|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.|||Participants|||Count of Participants
2823132|NCT00360126|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event is therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Only SAEs were recorded and reported in this extension study.|Up to 54 weeks|All subject population consisted of all participants enrolled into the study and received study drug.|||Participants|||Number
2823133|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tired State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823134|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tense State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823135|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Sad State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823136|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Happy State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823137|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Energetic State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823139|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Afraid State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823140|NCT00360009|Secondary|Change in Letter Fluency Tasks (LFT)|LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.|Pre-surgery baseline to 6 months of DBS stimulation||||T-score||Standard Deviation|Mean
2823141|NCT00360009|Secondary|Change in Beck Depression Inventory (BDI)|BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.|||T-score||Standard Deviation|Mean
2823142|NCT00360009|Secondary|Change in Spielberger State-Trait Anxiety Inventory (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.|||T-score||Standard Deviation|Mean
2823143|NCT00360009|Primary|Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.|||T-score||Standard Deviation|Mean
2823144|NCT00359983|Secondary|Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
2823145|NCT00359983|Secondary|hSBA-MenY Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Titer||95% Confidence Interval|Geometric Mean
2823146|NCT00359983|Secondary|Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
2823147|NCT00359983|Secondary|hSBA-MenC Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Titer||95% Confidence Interval|Geometric Mean
2823148|NCT00359983|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
2823149|NCT00359983|Secondary|Anti-PRP Geometric Mean Concentrations (GMCs)|"Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2823150|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
2823151|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
2823152|NCT00359983|Primary|Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.|||Subjects|||Number
2823153|NCT00359944|Secondary|Disability Assessment for Dementia (DAD)|"Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.~The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction."|Baseline to 16 Weeks||||units on a scale||Standard Deviation|Mean
2823154|NCT00359944|Secondary|Clinicians Interview Based Impression of Change (CIBIC)-Plus|"Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.~CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end."|Baseline to 16 weeks||||units on a scale||Standard Deviation|Mean
2823155|NCT00359944|Primary|Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)|Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.|Baseline to 16 weeks||||units on a scale||Standard Deviation|Mean
2823156|NCT00359801|Primary|Time to Persistent Decline in FEV1 Exceeding 20% From Baseline|Elapsed time, in days, from the start of subject's participation in the study to the first reading of FEV1 that is: 20% or more below the subject's latest pre-study measurement, subsequently confirmed as a >20% decline [(baseline observed value minus visit observed value)/by baseline observed value *100], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
2823157|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c taken as the latest determination prior to beginning study participation. Change = on-study value (for measurements falling within the time window associated with a given analysis set) minus the baseline value. Linear model with terms for treatment, baseline HbA1c, time on study, and subject within treatment.|Baseline to 5 years|FAS. Due to early study termination, the originally planned inferential analysis (linear model) for change from baseline was not done.|||percent|||Number
2823158|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c: the latest determination prior to beginning study participation. Change from Baseline: HbA1c at observation (falling within the time window associated with a given analysis set) minus the baseline value.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.|||percent||Standard Deviation|Mean
2823159|NCT00359801|Secondary|Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Elapsed time, in days, from the start of a subject's participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for allergic response. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
2823160|NCT00359801|Secondary|Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite or possible: anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction not otherwise specified (NOS); Insufficient: insufficient data.|Baseline through End of Study|FAS|||events|||Number
2823161|NCT00359801|Secondary|Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Elapsed time, in days, from the start of a subject's participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for cardiovascular SAE composite. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
2823162|NCT00359801|Secondary|Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event.|Baseline through End of Study|FAS|||events|||Number
2823163|NCT00359801|Primary|Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects|Confirmed FEV1 decline: any two consecutive declines that are >= 14 days apart. The pulmonary function test that established persistence occured >= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS|||participants|||Number
2823164|NCT00359801|Secondary|Time to Event: All-cause Mortality|Time to all-cause mortality: elapsed time, in days, from the start of a subject's participation in the study to the date of the event subsequently confirmed (according to protocol definition) as meeting the criteria for all-cause mortality. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
2823165|NCT00359801|Secondary|All-cause Mortality: Number of Deaths|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee.|Baseline through End of Study|FAS|||participants|||Number
2823166|NCT00359801|Secondary|Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Elapsed time, in days, from the start of a subject's participation in the study to the date of the first report of an event subsequently confirmed (according to protocol definition) as meeting the criteria for pulmonary SAE composite. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.|||days|||Number
2823167|NCT00359801|Secondary|Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data.|Baseline through End of Study|FAS|||events|||Number
2823168|NCT00359801|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Week 26, Week 52, Week 104, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.|||liters||Standard Deviation|Mean
2823169|NCT00359801|Primary|Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline|Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|Full Analysis Set: all randomized subjects.|||participants|||Number
2823170|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
2823171|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
2823172|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
2823173|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Units on a scale||Standard Error|Least Squares Mean
2823174|NCT00359788|Secondary|Evening PEFR at Week 12|Weekly means for evening PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823175|NCT00359788|Secondary|Evening PEFR at Week 11|Weekly means for evening PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823176|NCT00359788|Secondary|Evening PEFR at Week 10|Weekly means for evening PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823177|NCT00359788|Secondary|Evening PEFR at Week 9|Weekly means for evening PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823178|NCT00359788|Secondary|Evening PEFR at Week 8|Weekly means for evening PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823179|NCT00359788|Secondary|Evening PEFR at Week 7|Weekly means for evening PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823180|NCT00359788|Secondary|Evening PEFR at Week 6|Weekly means for evening PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823181|NCT00359788|Secondary|Evening PEFR at Week 5|Weekly means for evening PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823182|NCT00359788|Secondary|Evening PEFR at Week 4|Weekly means for evening PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823183|NCT00359788|Secondary|Evening PEFR at Week 3|Weekly means for evening PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823184|NCT00359788|Secondary|Evening PEFR at Week 2|Weekly means for evening PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823185|NCT00359788|Secondary|Evening PEFR at Week 1|Weekly means for evening PEFR|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823186|NCT00359788|Secondary|Morning PEFR at Week 12|Weekly means for morning PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823187|NCT00359788|Secondary|Morning PEFR at Week 11|Weekly means for morning PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823188|NCT00359788|Secondary|Morning PEFR at Week 10|Weekly means for morning PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823189|NCT00359788|Secondary|Morning PEFR at Week 9|Weekly means for morning PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823190|NCT00359788|Secondary|Morning PEFR at Week 8|Weekly means for morning PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823192|NCT00359788|Secondary|Morning PEFR at Week 6|Weekly means for morning PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823193|NCT00359788|Secondary|Morning PEFR at Week 5|Weekly means for morning PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823194|NCT00359788|Secondary|Morning PEFR at Week 4|Weekly means for morning PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823195|NCT00359788|Secondary|Morning PEFR at Week 3|Weekly means for morning PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823196|NCT00359788|Secondary|Morning PEFR at Week 2|Weekly means for morning PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823197|NCT00359788|Secondary|Morning Peak Expiratory Flow Rate (PEFR) at Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters/minute||Standard Error|Least Squares Mean
2823198|NCT00359788|Secondary|Night Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the night in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823199|NCT00359788|Secondary|Night Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the night in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823200|NCT00359788|Secondary|Night Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the night in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823201|NCT00359788|Secondary|Night Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the night in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823202|NCT00359788|Secondary|Night Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the night in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823203|NCT00359788|Secondary|Night Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the night in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823204|NCT00359788|Secondary|Night Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the night in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823205|NCT00359788|Secondary|Night Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the night in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823206|NCT00359788|Secondary|Night Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the night in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823207|NCT00359788|Secondary|Night Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the night in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823208|NCT00359788|Secondary|Night Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the night in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823209|NCT00359788|Secondary|Night Time Albuterol Use During Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per night||Standard Error|Least Squares Mean
2823210|NCT00359788|Secondary|Day Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the day in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823211|NCT00359788|Secondary|Day Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the day in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823212|NCT00359788|Secondary|Day Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the day in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823213|NCT00359788|Secondary|Day Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the day in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823214|NCT00359788|Secondary|Day Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the day in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823215|NCT00359788|Secondary|Day Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the day in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823216|NCT00359788|Secondary|Day Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the day in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823217|NCT00359788|Secondary|Day Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the day in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823218|NCT00359788|Secondary|Day Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the day in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823219|NCT00359788|Secondary|Day Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the day in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823220|NCT00359788|Secondary|Day Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the day in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823221|NCT00359788|Secondary|Day Time Albuterol Use During Week 1|Puffs of rescue albuterol used during the day in week 1|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Puffs per day||Standard Error|Least Squares Mean
2823222|NCT00359788|Secondary|FVC at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823223|NCT00359788|Secondary|FVC at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823224|NCT00359788|Secondary|FVC at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823225|NCT00359788|Secondary|FVC at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823226|NCT00359788|Secondary|FVC at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823227|NCT00359788|Secondary|FVC at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823228|NCT00359788|Secondary|FVC at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823229|NCT00359788|Secondary|FVC at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823230|NCT00359788|Secondary|FVC at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823231|NCT00359788|Secondary|FVC at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823232|NCT00359788|Secondary|FVC at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823235|NCT00359788|Secondary|FVC at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823236|NCT00359788|Secondary|FVC at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823237|NCT00359788|Secondary|FVC at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823238|NCT00359788|Secondary|FVC at 6 Hours on Day 1||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823239|NCT00359788|Secondary|FVC at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823240|NCT00359788|Secondary|FVC at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823241|NCT00359788|Secondary|FVC at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823242|NCT00359788|Secondary|FVC at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823243|NCT00359788|Secondary|FVC at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823244|NCT00359788|Secondary|FVC at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823245|NCT00359788|Secondary|FEV1 at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823246|NCT00359788|Secondary|FEV1 at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823247|NCT00359788|Secondary|FEV1 at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823248|NCT00359788|Secondary|FEV1 at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823249|NCT00359788|Secondary|FEV1 at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823250|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823251|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823252|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823253|NCT00359788|Secondary|FEV1 at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823254|NCT00359788|Secondary|FEV1 at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823255|NCT00359788|Secondary|FEV1 at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823256|NCT00359788|Secondary|FEV1 at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823257|NCT00359788|Secondary|FEV1 at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823258|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823259|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823260|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823261|NCT00359788|Secondary|FEV1 at 6 Hours on Day 1||6 hours|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823262|NCT00359788|Secondary|FEV1 at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823263|NCT00359788|Secondary|FEV1 at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823264|NCT00359788|Secondary|FEV1 at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Least Squares Mean||Standard Error|Least Squares Mean
2823265|NCT00359788|Secondary|FEV1 at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823266|NCT00359788|Secondary|FEV1 at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823267|NCT00359788|Secondary|FEV1 at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823268|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823269|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|baseline and 6 Weeks (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823270|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823271|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823272|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FVC AUC0-6 minus baseline FVC|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823273|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823274|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823275|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823276|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2827880|NCT00319982|Secondary|Safety and Tolerability of Diltiazem Treatment|Adverse events were compared between participants assigned to diltiazem and those assigned to placebo|Baseline through final study visits||||Participants Reporting Adverse Events|||Number
2823277|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823278|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823279|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823280|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FEV1 AUC0-6 minus baseline FEV1|Day 1 (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823281|NCT00359788|Secondary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823282|NCT00359788|Primary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823283|NCT00359788|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
2823284|NCT00359762|Secondary|Hypoglycemia Rate Per Year in Period III|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Start of Period III to end of study|Extension ITT Safety Population: Extension enrolled patients receiving at least one dose of study medication in Study Period III.|||events per subject-year||Standard Deviation|Mean
2823285|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy population. The analysis included patients not randomized at entry in study period III. Missing data at Year 2 was not imputed.|||percentage of total hemoglobin||Standard Deviation|Mean
2823286|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy Population: Extension enrolled patients with at least one post-baseline measurement of HbA1c in Study Period III. The analysis included patients randomized at entry in study period III. Missing data at Year 2 was not imputed.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2823287|NCT00359762|Secondary|Hypoglycemia Rate Per Year|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Baseline to end of Period II (up to 4.5 years)|ITT Safety Population.|||events per subject-year||Standard Error|Least Squares Mean
2823288|NCT00359762|Secondary|High-density Lipoprotein (HDL) Cholesterol at Year 3|HDL Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
2823289|NCT00359762|Secondary|Total Cholesterol at Year 3|Total Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
2823290|NCT00359762|Secondary|Triglycerides at Year 3|Triglycerides at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
2823291|NCT00359762|Secondary|Heart Rate at Year 3|Heart rate at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||beats per minute||Standard Error|Least Squares Mean
2823292|NCT00359762|Secondary|Diastolic Blood Pressure at Year 3|Diastolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmHg||Standard Error|Least Squares Mean
2823293|NCT00359762|Secondary|Systolic Blood Pressure at Year 3|Systolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmHg||Standard Error|Least Squares Mean
2823294|NCT00359762|Secondary|Change in Body Weight From Baseline to Year 3|Change in Body weight from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Safety Population: Enrolled patients receiving at least one dose of study medication in Study Period II with patients analyzed according to treatment actually received. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||kg||Standard Error|Least Squares Mean
2823295|NCT00359762|Secondary|Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint|Change from baseline in postprandial (2 hours) plasma glucose to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||mmol/L||Standard Error|Least Squares Mean
2823296|NCT00359762|Secondary|Postprandial (2 Hours) Plasma Glucose at Year 3|Postprandial (2 hours) plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
2823297|NCT00359762|Secondary|Change in Fasting Plasma Glucose From Baseline to Endpoint|Change in fasting plasma glucose from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||mmol/L||Standard Error|Least Squares Mean
2823298|NCT00359762|Secondary|Fasting Plasma Glucose at Year 3|Fasting plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||mmol/L||Standard Error|Least Squares Mean
2823299|NCT00359762|Secondary|Change in HbA1c From Baseline to Endpoint|Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2823300|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 3|Change in HbA1c from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2823301|NCT00359762|Secondary|Change in Disposition Index From Baseline to Endpoint|Change in disposition index from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
2823302|NCT00359762|Secondary|Disposition Index at Year 3|Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
2823303|NCT00359762|Secondary|Change in DI30/DG30 Ratio From Baseline to Endpoint|Change in DI30/DG30 ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
2823304|NCT00359762|Secondary|Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3|DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
2823305|NCT00359762|Secondary|Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.|Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
2823306|NCT00359762|Secondary|Fasting Proinsulin/Insulin Ratio at Year 3|Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
2823307|NCT00359762|Secondary|Change in HOMA-B From Baseline to Endpoint|Change in HOMA-B from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||ratio||Standard Error|Least Squares Mean
2823308|NCT00359762|Secondary|Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3|HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.|||ratio||Standard Error|Least Squares Mean
2823309|NCT00359762|Primary|Time to Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population.|||week||95% Confidence Interval|Median
2823310|NCT00359762|Primary|Number of Patients With Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population: Enrolled patients with a baseline and at least one post-baseline measurement of HbA1c in Study Period II (including only Study Period II); patients analyzed according to treatment as randomized.|||number of patients|||Number
2823311|NCT00359736|Primary|Change in 6-minute Walk Test|Distance in meters -- Distance (meters) walked in 6 minutes|0 - 6 months||||meters||Standard Deviation|Mean
2823312|NCT00359736|Secondary|Dyspnea Score (Borg Scale)|"The Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test.~The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness).~IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups."|0 - 6 months||||units on a scale||Standard Deviation|Mean
2823313|NCT00359632|Secondary|Percentage of Participants by Clinical Outcome of Infection at End of Study|Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.|At End of Study visit||||Percentage of Participants|||Number
2823314|NCT00359632|Primary|Percentage of Participants With an Adverse Event||Through and including 28 calendar days after the last administration of the investigational product||||Percentage of Participants|||Number
2823315|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.|From Month 0 to Month 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823316|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.|From Month 0 to Month 36|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823317|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.|From Month 0 to Month 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823318|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823319|NCT00359619|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823320|NCT00359619|Secondary|Number of Subjects With at Least One Medically Significant Condition (MAEs).|MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823321|NCT00359619|Secondary|Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2823322|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2823374|NCT00358917|Secondary|Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts||Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and who had CD4+ T cell counts at both the Baseline Visit and Week 48.|||cells/microliter||Standard Error|Mean
2823323|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
2823324|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL.||95% Confidence Interval|Geometric Mean
2823325|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
2823326|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2823327|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2823328|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
2823329|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2823330|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2823331|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||subjects|||Number
2823332|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|360 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <330 days or >390 days post-randomization are assigned an unfavorable outcome (mRS>2).|||participants|||Number
2823341|NCT00359424|Secondary|Incidence of Parenchymal Type II (PH2) Hematomas|a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans.|within 30 hours post IV rt-PA|Subjects were excluded if a post-baseline CT scan was not obtained within 30 hours of randomization (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window).|||participants|||Number
2823333|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|270 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <240 days or >300 days post-randomization are assigned an unfavorable outcome (mRS>2).|||participants|||Number
2823334|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 180 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <150 days or >210 days post-randomization are assigned an unfavorable outcome (mRS>2).|||participants|||Number
2823335|NCT00359424|Secondary|Trail Making Test Part B Time|"The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a trail made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes."|at 90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B.|||seconds||Standard Deviation|Mean
2823336|NCT00359424|Secondary|Trail Making Test Part A Time|"The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a trail made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes."|90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A.|||seconds||Standard Deviation|Mean
2823337|NCT00359424|Secondary|Barthel Index (BI) Dichotomized 0-90 Versus 95-100|The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing BI and BI measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (BI 0-90).|||participants|||Number
2823338|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.|The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (NIHSS score>1).|||participants|||Number
2823339|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.|"The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher~>> scores indicating greater severity of deficit."|at 24 hours post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <18 hours or >30 hours post-randomization are assigned an unfavorable outcome (NIHSS score>1).|||participants|||Number
2823340|NCT00359424|Secondary|Asymptomatic Intracranial Hemorrhage|Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site.|within 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.|||participants|||Number
2823361|NCT00359073|Primary|Mean Asthma Symptom Score|Asthma symptom scores were assessed twice per day with subjects completing a validated daytime diary card before bed and a nocturnal diary card on awakening. Subjects answered 4 questions about their asthma symptoms (0, none of the time; 6, all of the time). Daily score were calculated as the average of the 4 questions and an overall score for the week was assessed as the average of the daily scores. Time frame measurement was Day 7.|Day 7||||Asthma symptom score||Inter-Quartile Range|Median
2823342|NCT00359424|Primary|Symptomatic Intracranial Hemorrhage|Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site|within the first 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.|||participants|||Number
2823343|NCT00359424|Primary|Death Due to Any Cause||within 90 days post randomization|The intent-to-treat analysis includes all subjects who were randomized, and each subject analyzed according to the treatment group to which they were randomly assigned. Subjects who ended the study prior to 90 days post- randomization for a reason other than death (LTFU etc) (n=8 in group two; n=2 in group one) are assumed to be alive|||participants|||Number
2823344|NCT00359424|Primary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 90 days post randomization|The primary analysis was conducted according to intention to treat. All subjects were analyzed in the treatment group to which they were randomized. Subjects with missing mRS (n=9 in group two; n=4 in group one) or mRS assessed <60 days or >120 days post-randomization (n=10 in group two; n=4 in group one) are assigned an unfavorable outcome(mRS >2)|||participants|||Number
2823345|NCT00359281|Primary|AUC0-t Nicotinuric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823346|NCT00359281|Primary|AUC0-t Nicotinic Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823347|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823348|NCT00359281|Primary|AUC0-t Atorvastatin Acid (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823349|NCT00359281|Primary|AUC0-t Fenofibric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823350|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823351|NCT00359281|Primary|AUC0-t Total Ezetimibe|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823352|NCT00359281|Primary|AUC0-t Simvastatin Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823353|NCT00359281|Primary|AUC0-t Simvastatin|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin|0 to 24 hours|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823354|NCT00359281|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline to Day 8|Intention To Treat|||Percent Change||Standard Deviation|Mean
2823355|NCT00359281|Primary|Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)|0 to 24 hour|Pharmacokinetic|||Ratio||90% Confidence Interval|Geometric Mean
2823356|NCT00359216|Primary|Apnea-Hypopnea Index|Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.|change from baseline (screening) at the end of 28 days of treatment|Diary data over interval of days was derived using the mean of non-missing entries. No imputation was applied to any other missing data|||apnea-hypopnea episodes per hour||Standard Deviation|Mean
2823357|NCT00359203|Primary|Syncope Recurrence Rate|Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement|2 years|77 patients implanted with dual chamber pacemaker: 39 patients randomized to pacemaker OFF and 38 patients randomized to pacemaker ON|||percentage of participants||95% Confidence Interval|Number
2823358|NCT00359138|Primary|Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment|The number of days after treatment discontinuation until a measurable wheal and flare response.|Starting at Day 8||||Days||Standard Error|Mean
2823359|NCT00359073|Secondary|Sputum Eosinophil Count|Sputum was collected from both groups over 14 days after inoculation with the cold virus. Cell counts and differentials were made from sputum samples after treatment with 0.1% dithiothreitol. Eosinophils were counted and are expressed as as percentage of cells (percent of the total number counted) at the 14 day timepoint.|14 days||||percentage of eosinophils||Inter-Quartile Range|Median
2823360|NCT00359073|Secondary|Peak Viral Shedding|Viral shedding was measured in both groups. Viral titers from nasal lavage were calculated after 4 tissue culture tubes containing WI38 cells (human lung diploid cells) were inoculated for each serial 10-fold dilution of samples and incubated while rolling at 33 degrees Celsius for 10 days (measurement for analysis was taken at baseline and 7 days). Tubes were read at baseline and 7 days later. TCID50 was calculated as the concentration that was capable of infecting 50% of the tubes. Viral titers are expressed as TCID50 per milliliter. Time frame measurement was at baseline and 7 days.|Baseline and 7 days||||TCID50 per milliliter||Inter-Quartile Range|Median
2823411|NCT00358501|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events||Through 30 days from the last dose of Defibrotide|Safety population|||percentage of participants|||Number
2823362|NCT00359021|Secondary|Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)|In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).|Baseline, Week 24, Week 48, and Week 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.|||log10 copies/mL||95% Confidence Interval|Mean
2823363|NCT00359021|Secondary|The Percentage of Participants With Virologic Outcomes Over Time|The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).|Weeks 24, 48, and 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.|||Percentage of Participants|||Number
2823364|NCT00359021|Primary|The Number of Participants Experiencing Adverse Events|The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.|1 week to 180 weeks, with a median of 62 weeks|The safety analysis was carried out on the ITT population, which included all participants who received at least one dose of investigational medication.|||Participants|||Number
2823365|NCT00358956|Secondary|Biochemical Response Carcinoembryonic Antigen CEA)|A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation||||Participants|||Number
2823366|NCT00358956|Secondary|Biochemical Response Calcitonin (CTN )|A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters)||||Participants|||Number
2823367|NCT00358956|Secondary|Symptomatic Response|Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.|Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment.||||Participants|||Number
2823368|NCT00358956|Secondary|World Heath Organization (WHO) Performance Status|Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy - 5 dead) based on their physical capabilities|WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment.||||Participants|||Number
2823369|NCT00358956|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 24 weeks|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.||||Participants|||Number
2823370|NCT00358956|Secondary|Progression-Free Survival (PFS)|Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.||||Months||95% Confidence Interval|Median
2823371|NCT00358956|Primary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.||||Participants|||Number
2823372|NCT00358917|Secondary|Percentage of Participants With New Primary Protease Mutations at Week 48|Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).|Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and had post baseline genotypic resistance assay results.|||Percentage of Participants|||Number
2823373|NCT00358917|Secondary|Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir|Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.|Week 48 (End of Study)|Dropouts-as-censored: participants were responders if they had HIV-1 RNA <50 copies/mL at Week 48. Participants who discontinued (d/c'd) while suppressed or w/o post baseline (BL) levels were excluded. Those d/c'd <Day 85 were excluded unless they had >=1 post BL level & didn't achieve a decrease >=1.0 log10 copies/mL, then they were nonresponders.|||Percentage of Participants|||Number
2823375|NCT00358917|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48||Week 48 (End of Study)|Observed data analysis using all available Week 48 data from all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2823376|NCT00358917|Primary|Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.|Week 48 (End of Study)|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2823377|NCT00358826|Other Pre-specified|Change From Baseline in Percent Stenosis||Baseline and 24 weeks|Evaluable Population|||Percentage||95% Confidence Interval|Least Squares Mean
2823378|NCT00358826|Other Pre-specified|Change From Baseline in Mean Plaque Density|Plaque density is expressed in Hounsfield Units (HU)|Baseline and 24 weeks|Evaluable Population|||HU||95% Confidence Interval|Least Squares Mean
2823379|NCT00358826|Other Pre-specified|Change From Baseline in Noncalcified Plaque Volume||Baseline and 24 weeks|Evaluable Population|||mm^3||95% Confidence Interval|Least Squares Mean
2823380|NCT00358826|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy||Baseline and 24 weeks|Evaluable Population of the MDCT substudy|||mg/L||Inter-Quartile Range|Median
2823381|NCT00358826|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study||Baseline and 12 weeks|Evaluable Population|||mg/L||Inter-Quartile Range|Median
2823382|NCT00358826|Secondary|Change From Baseline in Leukotriene E4 (LTE4)|Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate|Baseline and 12 weeks|Core Study Evaluable Population|||pg/mg Cr||95% Confidence Interval|Least Squares Mean
2823383|NCT00358826|Primary|Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood||Baseline and 12 weeks|Core Study Evaluable Population|||pg/mL||95% Confidence Interval|Least Squares Mean
2823384|NCT00358735|Secondary|In-Patients' Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.~The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).~The compliance is expressed as percentages."|Surgery till discharge||||percentage of usage time|||Number
2823385|NCT00358735|Secondary|Serious Adverse Events|"Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.~SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures"|SAE data were collected Up to 3 months post-op||||events|||Number
2823386|NCT00358735|Post-Hoc|Composite Outcome of Major Bleeding + VTE|Major bleeding + DVT events + PE Events|Day of surgery and up to 3 months||||Events|||Number
2823387|NCT00358735|Post-Hoc|Changes in Hemoglobin Levels|Changes in Hemoglobin levels|After surgery untill discharge||||mean change (g/l)||Standard Deviation|Mean
2823388|NCT00358735|Post-Hoc|Bleeding Index ≥ 2|Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge|Surgery till discharge||||units on a scale||Standard Deviation|Mean
2823389|NCT00358735|Post-Hoc|Autologous Blood Transfusion Units|Autologous blood transfusion per patient in specific treatment Group|Up to 30 days||||Avg. Unit per patient in arm||Standard Deviation|Mean
2823390|NCT00358735|Post-Hoc|Allogeneic Blood Transfusion Units|Allogeneic blood transfusion per patient in specific treatment Group|Up to 30 days||||Avg. Unit per patient in arm||Standard Deviation|Mean
2823391|NCT00358735|Post-Hoc|Total Number of Blood Transfusion Units|Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)|Between the immediate postoperative measurement and discharge||||Units|Participants||Number
2823392|NCT00358735|Post-Hoc|Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)|Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods|Day of surgery and up to 3 months||||Events|Participants||Number
2823393|NCT00358735|Secondary|OutPatient Patients' Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.~The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).~The compliance is expressed as percentages."|10-12 days post-op||||percentage of usage time|||Number
2823394|NCT00358735|Secondary|Major Bleeding Complication|Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.|Up to 30 days||||Events|Participants||Number
2823395|NCT00358735|Primary|Clinical PE (Pulmonary Embolism) Events|Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT|Day of surgery and up to 3 months||||Events|Participants||Number
2823396|NCT00358735|Primary|Events of Deep Vein Thrombosis (DVT)|"10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.~Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods"|10-12 days post-op; and from day of surgery and up to 3 months if symptomatic||||Events|Participants||Number
2823412|NCT00358501|Secondary|Survival at Day+180 Post Hematopoietic Stem Cell Transplantation|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|180 days post hematopoietic stem cell transplant|Intent-to-Treat|||percentage of participants||95.1% Confidence Interval|Number
2823397|NCT00358670|Secondary|PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)|The PASI 12-month AUC is a time adjusted total PASI score over the 12 month (360 days) period. The AUC is a continuous measurement (not a score on a scale); and a lower value is considered better. The weighted average PASI score over 12 months (using all available PASI scores during a 12 month period [from Day 0 to 360 days]) is is obtained by using PASI 12-month AUC /360 days.|Day 0 to 360 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 330 days or more from Study P04563 randomization).|||12-month PASI AUC||Standard Error|Mean
2823398|NCT00358670|Secondary|PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)|The PASI 6-month AUC is a time adjusted total PASI score over the 6 month (180 days) period. The AUC is a continuous measurement (not a score on a scale); a lower value is considered better and a higher value is considered worse. The weighted average PASI score over 6 months (using all available PASI scores during a 6 month period [from Day 0 to 180 days]) is obtained by using PASI 6-month AUC /180 days.|Day 0 to 180 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 150 days or more from Study P04563 randomization).|||6-month PASI AUC||Standard Error|Mean
2823399|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 100|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|100 Weeks|Descriptive summary of all randomized subjects who completed 100 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 100.|||Participants|||Number
2823400|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 52|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|52 weeks|Descriptive summary of all randomized subjects who completed 52 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 52.|||Participants|||Number
2823401|NCT00358670|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128|PASI75 defined as the number of participants who achieved a >=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).|128 weeks|Due to the early termination of the study, no subjects completed 128 weeks of therapy.||||||
2823402|NCT00358644|Primary|Complete Response = Morphologic Complete Remission (mCR)||1 year|Intent-to-Treat (ITT)|||Participants|||Number
2823403|NCT00358579|Secondary|Survival to Admission.|Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital.|No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards||||Participants|||Number
2823404|NCT00358579|Secondary|Return of Spontaneous Circulation.|Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation.|during resuscitation||||Participants|||Number
2823405|NCT00358579|Secondary|Neurological Status at 1 Year.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 1 year post arrest||||Participants|||Number
2823406|NCT00358579|Secondary|Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 30 days post arrest||||Participants|||Number
2823407|NCT00358579|Primary|Survival to Hospital Discharge.|Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.|at 30 days post arrest||||Participants|||Number
2823408|NCT00358527|Primary|Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.|"Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time.~NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|29 days|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.|||Units on a scale||Standard Error|Least Squares Mean
2823409|NCT00358527|Primary|Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.|"The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12.~NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|Average of the last 7 days of treatment|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.|||Units on a scale||Standard Error|Least Squares Mean
2823410|NCT00358501|Other Pre-specified|Historical Control Group Adverse Event Information|Historical Control group was not assessed for severity|Through 30 days from the last dose of Defibrotide||||Number of patients|||Number
2823413|NCT00358501|Primary|Complete Response by Day+100 Post Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat|||percentage of participants||95.1% Confidence Interval|Number
2823414|NCT00358501|Primary|Survival at Day+100 Following Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat|||percentage of participants||95.1% Confidence Interval|Number
2823415|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of U. Parvum|In vitro susceptibilities of U. parvum|baseline|isolates|||MIC (ug/mL)||Full Range|Median
2823416|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2|In vitro susceptibilities of U. urealyticum biovar 2|baseline|isolates|||MIC (ug/mL)||Full Range|Median
2823417|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline|In vitro susceptibilities of M. genitalium to doxycycline|baseline||||MIC (ug/mL)||Full Range|Median
2823418|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin|In vitro susceptibiities of M. genitalium to azithromycin|baseline|Participants with recovered isolates that successfully underwent in vitro assessment of antibiotic susceptibilities|||Participants|||Count of Participants
2823419|NCT00358462|Secondary|Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit|Proportion of men with Ureaplasma urealyticum at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population|||participants|||Number
2823420|NCT00358462|Secondary|Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit|Proportion of men with M. genitalium at the initial study visit who had clinical cure, defined as <5 PMNs/HPF (with or without urethral symptoms) on a urethral Gram stain and absence of urethral discharge at follow-up.|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population|||participants|||Number
2823421|NCT00358462|Primary|mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit|Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit|3 weeks (allowable window 2-5)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for U. urealyticum at baseline|||participants|||Number
2823422|NCT00358462|Primary|mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit|Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for M. genitalium at baseline|||participants|||Number
2823423|NCT00358449|Secondary|Plasma Concentration of Mepolizumab|Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 to estimate the plasma concentration of mepolizumab. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.|||Microgram per milliliter (µg/mL)||Standard Deviation|Mean
2823424|NCT00358449|Secondary|Absolute Blood Eosinophils Count at the Indicated Time Points|Blood samples were obtained at Screening, pre-infusion and 24h and 72-96h post-infusion at Day 1, Weeks 4 and 8; and at Week 2, 6, 10, 12, 16, 20, 24 and 34 visits or Early Withdrawal Visit to estimate blood eosinophil count.|Screening, Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Giga cells per liter (GI/L)||Standard Deviation|Mean
2823425|NCT00358449|Secondary|Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an EGD with biopsies at Screening and at Weeks 12 and 24. Mean esophageal eosinophils were calculated as the mean number across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Cells/HPF||Standard Error|Mean
2823426|NCT00358449|Secondary|Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an esophagogastroduodenoscopy (EGD) with biopsies at Screening and at Weeks 12 and 24. Peak esophageal eosinophils were calculated as the maximum count across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Cells/HPF||Standard Error|Mean
2823427|NCT00358449|Secondary|Number of Participants With Maintenance of Response|Participants who achieved a response of <5 esophageal eosinophils/HPF at Week 12 by worst case analysis, were evaluated for maintenance of response of <20 cells/HPF at Week 24. Response categories were defined as: non-responder (did not respond at Week 12 or Week 24); delayed responder (did not respond at Week 12 but responded at Week 24); relapsed (responded at Week 12 but not at Week 24); maintained (responded at Week 12 and Week 24). The following assumptions were made for worst case: if a Participant dropped out of the study due to lack of efficacy or an adverse event and had a missing response, their response was imputed as not achieved (i.e. failure). However for Participants withdrawn for other reasons (e.g. lost to follow-up) with a missing response (i.e. did not have the biopsy) the response was made as missing and not imputed.|Week 12 and Week 24|ITT Population. Only those participants were responders at Week 12 were analyzed.|||Participants|||Number
2823542|NCT00357903|Secondary|Childhood Health Assessment Questionnaire|Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).|Month 12|All participants who received at least one dose of etanercept and had available data|||Units on a scale||Standard Deviation|Mean
2823428|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years)|The percentage of days with feeling of something stuck in throat during each analysis period (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823429|NCT00358449|Secondary|Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only)|Par. and/or parent/guardian recorded daily symptoms of the feeling like something is stuck in throat on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom of feeling of something stuck was not experienced. On days that feeling of something stuck in the throat was experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. Average bothersome score was calculated as the sum of the respective scores for that interval divided by the number of days. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
2823430|NCT00358449|Secondary|Change From Baseline in the Percentage of Days Participants Ate Solid Foods|The percentage of days with the symptom of difficulty and pain when eating solid foods during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823431|NCT00358449|Secondary|Change in Baseline in Pain With Eating Solid Foods Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned for that symptom when Par. did not eat. The severity of pain was assessed when Par. eats food as: 1=didn't hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823432|NCT00358449|Secondary|Change From Baseline in Difficulty With Eating Solid Foods|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP and FP. A score of 6 was assigned for that symptom when Par. did not eat solid foods. When Par.eat solid foods, the amount of difficulty was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interactions.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823433|NCT00358449|Secondary|Change From Baseline in Percentage of Days on Which the Participant Drank|The percentage of days with the symptom of difficulty and pain when participant drank during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823543|NCT00357903|Secondary|Health Assessment Questionnaire Disability Index|Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).|Month 12|All participants who received at least one dose of etanercept and had available data|||Units on a scale||Standard Deviation|Mean
2823434|NCT00358449|Secondary|Change From Baseline in Pain With Drinking Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned the day participant did not drink. The severity of pain was assessed as: 1=didn't hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average difficulty and pain severity scores was calculated as the sum of the respective scores for that interval divided by the number of days in the interval. . Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823435|NCT00358449|Secondary|Change From Baseline in Daily Degree of Difficulty With Drinking|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned days the participant did not drink. The amount of difficulty with drinking was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average difficulty for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the drinking difficulty scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
2823436|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Vomiting|The percentage of days with the symptom of vomiting during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823437|NCT00358449|Secondary|Change From Baseline in Frequency of Vomiting|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A participant vomiting any time was counted as one episode of vomiting, irrespective of how close they are to each other. The daily frequency of vomiting was calculated as the total number of times the participant vomited during the interval divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Occurrences of vomiting per day||95% Confidence Interval|Least Squares Mean
2823438|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores|The percentage of days with the symptom of pain in regurgitation bothersome during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823439|NCT00358449|Secondary|Change From Baseline in Regurgitation Bothersome Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom regurgitation was not experienced. The days regurgitation experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for Baseline score, treatment group, age group interactions|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823544|NCT00357903|Secondary|Swollen Joint Count|Number of swollen joints|Month 12|All participants who received at least one dose of etanercept and had available data|||Joints||Standard Deviation|Mean
2823545|NCT00357903|Secondary|Tender Joint Count|Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation|Month 12|All participants who received at least one dose of etanercept and had available data|||Joints||Standard Deviation|Mean
2823440|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Chest/Throat|The percentage of days with the symptom of pain in chest/throat during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823441|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Stomach|The percentage of days with the symptom of pain in stomach during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2823442|NCT00358449|Secondary|Change From Baseline in Pain in Chest/Throat Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in chest/throat was not experienced. If pain in chest/throat was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823443|NCT00358449|Secondary|Change From Baseline in Pain in Stomach Severity Scores|Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric Analysis of Covariance (ANCOVA) models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The observed case (OC) datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2823444|NCT00358449|Primary|Plasma Clearance (CL) of Mepolizumab|Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population|||Liters per Day (L/day)||95% Confidence Interval|Geometric Mean
2823445|NCT00358449|Primary|Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate central (V1) and periperial (V2) and Steady State (Vss) volume of distribution of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.|||Liters||95% Confidence Interval|Geometric Mean
2823446|NCT00358449|Primary|Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12|A responder was defined as a participant achieving a reduction in esophageal eosinophils to <5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. lost to follow-up) were considered non-evaluable for the primary analysis. For participants who withdrew early from the study and had a biopsy, the biopsy was used to determine their response.|Week 12|ITT Population-WC|||Participants|||Number
2823447|NCT00358449|Primary|Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit.|Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit category: results were considered as postive if the result was positive at >1 visit, and results were considered as negative if the result was negative at all visits or was positive at only one visit.|Day 1, Weeks 4, 8, 12, 24, and 34|ITT Population|||Participants|||Number
2823448|NCT00358449|Primary|Change From Baseline in Temperature at the Indicated Time Points|Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Degree Celsius (°C)||Standard Deviation|Mean
2823449|NCT00358449|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Beats per minutes||Standard Deviation|Mean
2823450|NCT00358449|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2823451|NCT00358449|Primary|Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline|"12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. any time post Baseline. Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable."|Screening, Weeks 4, 8 and 12|ITT Population|||Participants|||Number
2823452|NCT00358449|Primary|Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period.|Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)|ITT Population. Only those participants available at specified time points are analyzed.|||Participants|||Number
2823453|NCT00358449|Primary|Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period.|Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|||Participants|||Number
2823454|NCT00358449|Primary|Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE's were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related AEs are summarized by TP and FP.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|Intention-to-Treat (ITT) Population: all participants who gave informed consent, were randomized and received at least one dose of medication.|||Participants|||Number
2823455|NCT00358436|Primary|Trough FEV1 (L) at 12 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks|12 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
2823546|NCT00357903|Primary|Death|Occurrence of death on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
2823456|NCT00358436|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Percentage of Patients|||Number
2823457|NCT00358436|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Days||95% Confidence Interval|Median
2823458|NCT00358436|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks|28 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.|||Liters||Standard Error|Least Squares Mean
2823459|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 364 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823460|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 272 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823461|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 180 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823462|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 90 +/- 10 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823463|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 60 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823464|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 30 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823465|NCT00358332|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.|||Participants|||Number
2823466|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 0|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.|||log anti-FMP2.1 titer||95% Confidence Interval|Mean
2823467|NCT00358332|Primary|Number of Subjects Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|1 year after the last vaccination.|This outcome includes all enrolled subjects.|||Participants|||Number
2823468|NCT00358332|Primary|Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Day of vaccination and 30 subsequent days.|This outcome includes all enrolled subjects.|||Participants|||Number
2823469|NCT00358332|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.|||Participants|||Number
2823547|NCT00357903|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
2823470|NCT00358215|Secondary|Change From Baseline to Month 6 in KCCQ Symptom Frequency Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.|||units on a scale||Standard Error|Least Squares Mean
2823471|NCT00358215|Secondary|Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.|||units on a scale||Standard Error|Least Squares Mean
2823472|NCT00358215|Secondary|Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure|Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat|||days||Inter-Quartile Range|Median
2823473|NCT00358215|Secondary|Time to Death From Any Cause|Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat|||days||Inter-Quartile Range|Median
2823474|NCT00358215|Primary|Time to All Cause Death or First Hospitalization for Worsening Heart Failure|Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat (ITT) analysis set, defined as all randomized participants|||days||Inter-Quartile Range|Median
2823475|NCT00358150|Secondary|Lumbar Spine and Femur Z-Scores for BMD at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||Z-Score||Standard Deviation|Mean
2823476|NCT00358150|Secondary|Lumbar Spine and Femur T-Scores for Bone Mineral Density (BMD) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by dual energy X-ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-scores compares participant's bone density with that of healthy young participant of same gender. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||T-Score||Standard Deviation|Mean
2823477|NCT00358150|Secondary|Bone Marrow Infiltration: Number of Participants With Improvement From Baseline in Dark Marrow at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (EOS)|Bone marrow infiltration assessments were designed to evaluate improvements in dark marrow using MRI. Each MRI assessment was performed for both femurs and consisted of reviewing 6 different zones (the femoral head, greater trochanter, intertrochanteric region, shaft, distal metaphysis, and condyles). MRI images recorded dark marrow for each zone as either present or not present at baseline. In this outcome, number of participants (for whom dark marrow was present at baseline) with improvement from baseline in dark marrow at each specified time point were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ’n’ signifies number of participants who were presented with dark marrow at baseline and had data available at specified time points.|||Participants|||Count of Participants
2823478|NCT00358150|Secondary|Number of Participants With No Bone Crisis at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with 0= no bone crises levels at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||participants|||Number
2823479|NCT00358150|Secondary|Number of Participants With Mobility Status (MS) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Mobillity, i.e. ability to walk was assessed as a part of Gaucher disease assessment in participants.In this outcome, number of participants with their different mobility status (unrestricted mobility, walks with difficulty) at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||participants|||Number
2823480|NCT00358150|Secondary|Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain and moderate bone pain. In this outcome, number of participants with different levels of bone pain at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||participants|||Number
2823481|NCT00358150|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|The FSS is an instrument consisting of 9 self-administered questions that measures the impact of severity of fatigue symptoms on everyday functioning, based on the recall over the past week. Score range for each question ranges from 1 (minimum) to 7 (maximum), where higher score indicates greater severity. FSS total score was calculated by averaging the results of all questions. Total FSS score ranges from 9 (minimum) to 63 (maximum), where higher scores indicates greater severity.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
2823482|NCT00358150|Secondary|Change From Baseline in 36-Item Short Form (SF-36) Health Survey Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and Year 9 at End of Study|The SF-36 questionnaire, version 2, investigates the participant's health-related quality of life (HRQL). It is a 36-item questionnaire measuring 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life. Two summary scale scores were computed from the 8 domain scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
2823483|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Chitotriosidase) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
2823484|NCT00358150|Secondary|Percent Change From Baseline in Biomarker Chemokine Ligand 18 (CCL18) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
2823485|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Tartrate-Resistant Acid Phosphatase [TRAP]) Level at Year 1 and Year 2||Baseline, Year 1, Year 2|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points. As per the change in planned analysis, TRAP was not assessed after Year 2.|||percent change||Standard Deviation|Mean
2823486|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Angiotensin Converting Enzyme) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time point.|||percent change||Standard Deviation|Mean
2823487|NCT00358150|Secondary|Percent Change From Baseline in Platelet Count at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in platelet count = ([platelet count at specified time points minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
2823488|NCT00358150|Secondary|Absolute Change From Baseline in Hemoglobin at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Absolute change = hemoglobin level at specified time points minus hemoglobin level at baseline.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||g/dL||Standard Deviation|Mean
2823489|NCT00358150|Secondary|Percent Change From Baseline in Liver Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in liver volume = ([liver volume at specified time points minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
2823490|NCT00358150|Secondary|Percent Change From Baseline in Spleen Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in spleen volume = ([spleen volume at specified time points minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.|||percent change||Standard Deviation|Mean
2823491|NCT00358150|Primary|Percentage of Participants Demonstrating A Meaningful Clinical Response|A meaningful clinical response was defined as an improvement in at least 2 of the 3 main efficacy parameters: a) an increase in hemoglobin of greater than or equal to (>=) 0.5 gram/deciliter from baseline, b) an increase in platelets of >=15 percent (%) from baseline, c) reduction in total spleen volume of >= 15% from baseline. As hemoglobin, platelets, total spleen volume were abnormal at baseline, within each participant, only those parameters were used in the evaluation of meaningful clinical response which were abnormal at baseline.|Baseline, Year 1|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat.|||percentage of participants|||Number
2823492|NCT00358007|Primary|Average Residual Error Motion of Patients Undergoing Radiotherapy|To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms|Daily after each radiotherapy treatment||||millimeters||Standard Deviation|Mean
2823493|NCT00358007|Primary|Average Interfraction Shift of Patients Undergoing Radiotherapy|"Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan.~Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken."|Daily prior to radiation||||millimeters||Standard Deviation|Mean
2823494|NCT00357994|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
2823495|NCT00357994|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.|||participants|||Number
2823496|NCT00357994|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823497|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823498|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
2823499|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823548|NCT00357903|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
2823500|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.|||units on a scale||Standard Error|Least Squares Mean
2823501|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823502|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823503|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823504|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823505|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823506|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823515|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823507|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823508|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823509|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823510|NCT00357994|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823511|NCT00357994|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823512|NCT00357994|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823513|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2823514|NCT00357994|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2823527|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|From loading dose to day 15|Includes patients who received a single loading dose and had evaluable MPA measures, regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients had received 14 days of maintenance treatment but had not crossed-over to the alternate maintenance treatment.|||participants|||Number
2823549|NCT00357903|Primary|Malignancy|Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Participants|||Number
2823516|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
2823517|NCT00357994|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.|||hours||Standard Error|Least Squares Mean
2823518|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose|Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.|||ng/ml||Standard Deviation|Mean
2823519|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose|Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.|||ng/ml||Standard Deviation|Mean
2823520|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose|Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.|||IU/L||Standard Deviation|Median
2823521|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose|Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.|||IU/L||Standard Deviation|Mean
2823522|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|after 14 days of maintenance dosing|Includes patients who received a loading dose and PCI, regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)|||percent (%) platelet reactivity index||Standard Deviation|Mean
2823523|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements.|||percent (%) platelet reactivity index||Standard Deviation|Mean
2823524|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, and had evaluable VASP measurements, and did not receive a GP IIb/IIIa antagonist. Patients had received a single loading dose but had not yet received any maintenance treatment.|||percent (%) platelet reactivity index||Standard Deviation|Mean
2823525|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|2 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements. Patients had received a single loading dose but had not yet received any maintenance treatment.|||percent (%) platelet reactivity index||Standard Deviation|Mean
2823526|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|14 days after cross-over|Includes patients who received a single loading dose and had evaluable MPA measures,regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients received 14 days of maintenance treatment and then crossed-over to the alternate maintenance treatment for 14 days.|||participants|||Number
2823528|NCT00357968|Secondary|Number of Hyporesponsive Participants at 6 Hours After the Loading Dose|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|6 hours after loading dose|"Includes patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist and had evaluable pre-treatment, and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."|||participants|||Number
2823529|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|14 days after cross-over|Includes all patients who received a loading dose and underwent PCI, received a maintenance dose for 14 days, and then crossed-over to the alternate therapy for an additional 14 days of maintenance dosing.|||participants|||Number
2823530|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|after 14 days of treatment (before cross-over)|Includes all patients who received a loading dose. Patients who underwent PCI also received 14 days of maintenance treatment. Patients had not yet crossed-over to the alternate maintenance treatment.|||participants|||Number
2823531|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|14 days after cross-over|All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy.|||participants|||Number
2823532|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|after 14 days of treatment (before cross-over)|Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose.|||participants|||Number
2823533|NCT00357968|Secondary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.|2 hours after loading dose|Includes all patients who received a loading dose of study drug, did not receive a GP IIb/IIIa antagonist and had evaluable pretreatment and 2 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.|||percent inhibition||Standard Deviation|Mean
2823534|NCT00357968|Primary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment|"Measures IPA during maintenance dosing before and after cross-over for each therapy.~IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100."|after 14 days of maintenance dosing|Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)|||percent inhibition||Standard Deviation|Mean
2823535|NCT00357968|Primary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.|6 hours after loading dose|"Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."|||percent inhibition||Standard Deviation|Mean
2823536|NCT00357955|Primary|Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg|The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L).|4 months||||percentage|||Number
2823537|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 10 years|All participants who received at least one dose of etanercept|||Events per 100 participant-years|||Number
2823538|NCT00357903|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.|up to 10 years|All participants who received at least one dose of etanercept|||Observed count / expected count|||Number
2823539|NCT00357903|Secondary|JRA DOI 30 at Month 3 in Juveniles|Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.|Baseline and month 3|All participants who received at least one dose of etanercept and were evaluable for this endpoint at 3 months|||Participants|||Number
2823540|NCT00357903|Secondary|ACR20 at Month 3 in Adults|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 3|All participants who received at least one dose of etanercept and had available data at both baseline and month 3|||Participants|||Number
2823541|NCT00357903|Secondary|C-Reactive Protein|C-reactive protein at month 12|Month 12|All participants who received at least one dose of etanercept and had available data|||mg/dL||Standard Deviation|Mean
2823550|NCT00357903|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Lymphomas per 100 participant-years|||Number
2823551|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Events per 100 participant-years|||Number
2823552|NCT00357903|Primary|Total Exposure Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Deaths per 100 participant-years|||Number
2823553|NCT00357903|Primary|Total Exposure Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept|||Malignancies per 100 participant-years|||Number
2823554|NCT00357903|Secondary|Dosing Period|Duration of etanercept dosing|Up to 10 years|All participants who received at least one dose of etanercept|||Days||Standard Deviation|Mean
2823555|NCT00357903|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps|Up to 10 years|All participants who received at least one dose of etanercept|||Participant-years|||Number
2823556|NCT00357877|Secondary|Cumulative Crude D12FS Caries Increment|This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.|Visit 1, 7-month follow-up, 13-month follow-up|Intention-to-Treat sample|||caries increment units/13 months||Standard Error|Mean
2823557|NCT00357877|Secondary|Total Crude D12FS Caries Increment|Computed analogous to the total net D12FS caries increment, but ignoring reversals (essentially assigned them zero weight). Computed only using baseline to 13-month visit data.|V1-13-month follow-up|Intention-to-Treat sample|||caries increment units/13 months||Standard Error|Mean
2823558|NCT00357877|Secondary|Cumulative Net D12FS Caries Increment|This measure was computed similar to the total net D12FS increment, but separately scored and combined transitions from the baseline to 7-month visits and from the 7- to 13-month visits, rather than simply looking at the baseline to 13-month visits.|Visit 1, 7-month follow-up, 13-month follow-up|Intention-to-Treat sample|||caries increment units/13 months||Standard Error|Mean
2823559|NCT00357877|Primary|Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))|"Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis.~This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = −1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a"|(V1) to the 13 month follow-up visit|Intention to treat (ITT) sample. Multiple imputation with 8 datasets imputed via Markov Chain Monte Carlo sampling was used to handle missing data.|||weighted increment units/13 months||Standard Error|Mean
2823560|NCT00357760|Other Pre-specified|Angiogenesis-related Protein Expression||Assessed every 8 weeks during treatment and end of treatment|||||||
2823561|NCT00357760|Other Pre-specified|Circulating Levels of VEGF-Trap Complex||Assessed at baseline, 4 weeks, 6 weeks, 8 weeks and end of treatment|||||||
2823562|NCT00357760|Secondary|Progression-free Survival (PFS) Among Patients Who Undergo Dose Escalation Following Progression on Lower-dose VEGF Trap|"Patients who progressed on the 1 mg/kg dose (Arm B) at 8 weeks would have the opportunity to receive the 4 mg/kg dose. PFS is defined as the time from dose escalation to disease progression or death, whichever occurs first.~Disease progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions."|Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment|Only patients who progressed on the low dose (Arm B) and underwent dose escalation were included in this analysis.|||weeks||90% Confidence Interval|Median
2823563|NCT00357760|Secondary|Proportion of Patients With Objective Response|"Objective response is defined as complete response (CR) or partial response (PR) determined by Solid Tumor Response Criteria (RECIST).~CR: The disappearance of all target lesions without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions.~PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter without the appearance of new lesion(s) and/or unequivocal progression of existing non-target lesions.~To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|Assessed every 8 weeks while on treatment and then every 3 months until patient is 2 years from enrollment, and then every 6 months until patient is 3 years from enrollment|Eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2823564|NCT00357760|Primary|Proportion of Patients Alive and Progression-free at 8 Weeks|"Progression-free survival (PFS) was defined as time from randomization to the earlier of documentation of progression or death. The proportion of patients who are progression-free and alive at 8 weeks was estimated using the Kaplan-Meier method and the confidence interval was estimated using log transformation method.~Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameters of target lesions, or the appearance of new lesions, or unequivocal progression of existing nontarget lesions."|Assessed at 8 weeks|Eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2823565|NCT00357734|Primary|Number of Other Adverse Events (AEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||number of other AEs related to ZD1839|||Number
2823566|NCT00357734|Primary|Number of Other Adverse Events (AEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||number of other AEs|||Number
2823567|NCT00357734|Primary|Number of Serious Adverse Events (SAEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||Number of SAEs related to ZD1839|||Number
2823568|NCT00357734|Primary|Number of Serious Adverse Events (SAEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)||||number of SAEs|||Number
2823569|NCT00357734|Secondary|Overall Survival (OS)||From randomization until death (up to 120 months)||||Months||95% Confidence Interval|Median
2823570|NCT00357734|Secondary|Progression-free Survival (PFS)|Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From randomization until progression or death (up to 120 months)||||Months||95% Confidence Interval|Median
2823571|NCT00357656|Secondary|Incidence of Factor VIII Inhibitory Antibody (≥0.4 Bethesda Units Using the Nijmegen Modification of the Bethesda Assay Formation)|Number of participants that developed Factor VIII inhibitory antibody during the study.|Throughout the study period of approximately 9-26 weeks per participant|Participants in the Safety Analysis Set treated with at least one ADVATE infusion.|||Participants|||Number
2823572|NCT00357656|Secondary|Number of Adverse Events Related to the Administration of the Study Product.|All AEs from the first study drug exposure until the study completion/discontinuation date were to be recorded. Each AE was to be evaluated by the investigator for causal relationship (i.e., unrelated, possibly related or probably related) to the study product.|From first study drug exposure until study completion/discontinuation (approximately 9-26 weeks per subject)|Participants in the Safety Analysis Set treated with at least one ADVATE infusion.|||Adverse Events|||Number
2823573|NCT00357656|Secondary|Number of Units of Packed Red Blood Cells Transfused||During the first postoperative 24 hours|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||PRBC Units||Standard Deviation|Mean
2823574|NCT00357656|Secondary|Number of Bleeding Episodes During Treatment With Continuous or Bolus Infusion|To simplify the results below: Bleeding episodes were reported for 4 subjects (3 subjects on bolus infusion: 2 in Stratum A and 1 in Stratum B, and 1 subject on continuous infusion/Stratum B). The 4 subjects had 1 bleeding episode each. No bleeding episodes were reported for Stratum C.|Through Postoperative Day 7|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Bleeding Episodes||Standard Deviation|Mean
2823575|NCT00357656|Secondary|Actual Postoperative Blood Loss Compared to the Expected Average Blood Loss Until Drain Removal as Predicted Preoperatively by the Surgeon|"The total blood loss for the postoperative period (from end of surgery until drain removal) was adjusted for the expected blood loss by applying a log-transformation of the blood loss data.~The drainage volume was measured every 8 hours +/- 30 minutes during the first 24 hours. If the drainage continued beyond 24 hours, the PRBC volume and hemoglobin was to be measured cumulatively every 24 hours or whenever the drainage bottle was emptied and at the time of drain removal. Prior to surgery, the operating surgeon was to predict the estimated duration of surgery and the volume (mL) of the estimated expected blood loss for the surgery in a hemostatically normal individual of the same sex, age, and stature as the study subject for the first 24 hours postoperatively, and for the postoperative period until drain removal, if drainage continued beyond 24 hours.~Units: Milliliter of blood"|From end of surgery (application of compressive dressing and release of tourniquet, if applicable) until drain removal (up to postoperative day 7).|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Milliliter||Standard Deviation|Mean
2823576|NCT00357656|Secondary|Actual Postoperative Blood Loss During the First 24 Hours Compared With the Average Blood Loss as Predicted Preoperatively by the Operating Surgeon|"Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery. Prior to surgery, the operating surgeon was to predict the estimated duration of surgery and the volume (mL) of the estimated expected blood loss for the surgery in a hemostatically normal individual of the same sex, age, and stature as the study subject 1) for the intraoperative procedure (defined as the time period from incision to application of compressive dressing and release of tourniquet, if applicable), 2) for the first 24 hours postoperatively, and 3) for the postoperative period until drain removal, if drainage continued beyond 24 hours.~Units: Milliliter of blood"|During the first 24 postoperative hours blood loss was measured every 8 hours ± 30 minutes|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Milliliter||Standard Deviation|Mean
2823577|NCT00357656|Primary|Cumulative Packed Red Blood Cell (PRBC) Volume in the Drainage Fluid During the First 24 Hours Following Surgery in Subjects Receiving ADVATE (rAHF-PFM) by Bolus (BI) or Continuous Infusion (CI)|"Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery.~Unit of measure: Tera per Liter is the PRBC concentration in 10^12 units per 1 liter of drainage fluid."|During the first postoperative 24 hours every 8 hours ± 30 minutes the drainage fluid was to be recorded..|"All subjects who were randomized to receive BI or CI and have observed drainage volumes up to 24 hours including hematocrit results for these drainage fluids.~The overall number of participants treated by BI and CI comprises the number of participants in Stratum A, B and C for BI and CI."|||Tera per Liter||Standard Deviation|Mean
2823578|NCT00357552|Secondary|Change in CD4+ Cell Counts From Study Entry to Week 104||Study entry and week 104|All participants enrolled.|||cells/mm^3||Inter-Quartile Range|Median
2823579|NCT00357552|Secondary|Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104||At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104|All participants enrolled.|||proportion of participants|||Number
2823580|NCT00357552|Secondary|HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma|HIV-1 viral sequencing as ascertained from paired DBS and plasma|At study entry and virologic failure|HIV-1 viral sequence testing in DBS was not performed||||||
2823581|NCT00357552|Secondary|Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma|Proportion of DBS samples with HIV-1 RNA level <= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level <= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both <= 400 copies/mL or both > 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature).|At study entry and weeks 24 and 48|Participants with DBS samples available at study entry, week 24 or 48, with corresponding plasma HIV-1 RNA levels.|||proportion of samples|paired DBS and plasma samples||Number
2823582|NCT00357552|Secondary|Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification|25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From LPV/r intensification to week 104|All participants enrolled.|||weeks||95% Confidence Interval|Number
2823583|NCT00357552|Secondary|Percentage of Subjects Reporting Not Skipping Medications in the Last Month.|The percentage of subjects reporting never missing medications in the last month.|Study entry and weeks 2, 4, 8, 12, 16, 20, and 24|All participants enrolled.|||percentage of subjects with data|||Number
2823584|NCT00357552|Secondary|Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.|Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.|At time of virologic failure|16 subjects met the criteria for endpoint failure; 15 subjects were virologic failures and 1 subject intensified prior to virologic failure. Of the 15 subjects with virologic failure, 11 had sequence data, and sequencing failed for 4.|||participants|||Number
2823585|NCT00357552|Secondary|Number of Participants With Study-targeted Diagnoses and Clinical Events|Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.|Study entry to week 104|All participants enrolled.|||participants|||Number
2823586|NCT00357552|Secondary|Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.|25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.|Study entry to Week 104|All participants enrolled.|||weeks||95% Confidence Interval|Number
2823587|NCT00357552|Secondary|Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.|Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.|Screening|All screened individuals.|||number of screened subjects|||Number
2823588|NCT00357552|Primary|Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.|Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to week 24|All enrolled individuals.|||cumulative probability of grade 3 or 4||95% Confidence Interval|Number
2823783|NCT00356200|Primary|Change in Target Lesion Score at Week 4 Compared to Baseline|Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4|||units on a scale||Standard Deviation|Mean
2823589|NCT00357552|Primary|Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy|Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL.|From study entry to week 24|All enrolled individuals.|||percentage of enrolled subjects||90% Confidence Interval|Number
2823590|NCT00357500|Secondary|Best Response|As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.||||participants|||Number
2823591|NCT00357500|Secondary|27-Week Overall Survival|27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.|||Probability||95% Confidence Interval|Number
2823592|NCT00357500|Secondary|27-Week Progression-Free Survival|27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.|||Probability||95% Confidence Interval|Number
2823593|NCT00357500|Primary|Therapy Completion Rate|Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|27 weeks|The analysis dataset is comprised of all treated patients.|||proportion of patients||90% Confidence Interval|Number
2823594|NCT00357396|Primary|Overall Objective Response||2 years||||participants|||Number
2823595|NCT00357370|Secondary|Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2|Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing TDDI values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||units/day||Standard Error|Mean
2823596|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||Participants|||Number
2823597|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||Participants|||Number
2823598|NCT00357370|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||Participants|||Number
2823613|NCT00357097|Secondary|"Change From Average Baseline Scores of Subscale Sleep Disturbance of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks"|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
2823599|NCT00357370|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing FPG values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||mg/dL||Standard Error|Mean
2823600|NCT00357370|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.|From Baseline to Week 12|Chort 2 all randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.|||% of hemoglobin||Standard Error|Mean
2823601|NCT00357331|Primary|P1NP (Amino-terminal Propeptide of Type I Procollagen)|One measure of bone turnover was P1NP as a morning lab draw.|Baseline,1,3,6,12 months|The numbers analyzed reflect the number of participants evaluable at each time point.|||micrograms/L||Standard Deviation|Mean
2823602|NCT00357331|Secondary|Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.|BMD was performed at lumbar spine, total hip and femoral neck using dual-energy X-ray Absorptiometry (DXA) Hologic; Bedford, Massachusetts.|1 year||||Participants|||Count of Participants
2823603|NCT00357331|Primary|Urinary-N-telopeptide|One measure of bone turnover was urinary-NTX as a second void morning urine.|Baseline,1,3,6,12 months|The numbers analyzed reflect the number of participants evaluable at each time point.|||nml BCE/nmol creatinine||Standard Deviation|Mean
2823604|NCT00357214|Primary|Biochemical Markers of Bone Turnover|Change in 24-hr urinary N-telopeptide/creatinine measured at baseline and 3 months|3 month change in 24-hr urine values||||nmol/mmol||Standard Error|Mean
2823605|NCT00357162|Secondary|Toxicity of Belinostat in Patients With Myelodysplastic Syndrome|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Reporting events deemed at least possibly related to study treatment.|Prior to each course (every 21 days), and every 3 months for up to 3 years after completion of study treatment||||participants|||Number
2823606|NCT00357162|Secondary|Duration of Response|Estimated using the method of Kaplan-Meier.|From the date of documented response until the date of progression or last follow-up, assessed up to 3 years|One participant had a confirmed Hematologica Improvement. For patient confidentiality, we are not reporting response data.||||||
2823607|NCT00357162|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From date of registration to the date of last follow-up or death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2823608|NCT00357162|Secondary|Time to Progression|Estimated using the method of Kaplan-Meier.|Time from registration to the date of progression or last follow-up, assessed up to 3 years||||months||95% Confidence Interval|Median
2823609|NCT00357162|Primary|Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart|"Complete Response (CR)~A CR is defined as a participant with bone marrow showing less than 5% myeloblasts with no evidence of dysplasia and with adequate peripheral blood counts for at least 2 months (hemoglobin > 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3) and with no blasts in the peripheral.~Partial Response (PR)~All the CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment, or a less advanced WHO classification than pretreatment.~Hematologic Improvement (HI)~A 2g/dl increase in hemoglobin for participants with <11g/dl hemoglobin at pretreatment, or an increase of >30,000/mm^3 platelets for participants with <100,000/mm^3 at pretreatment, or a 100% increase in neutrophil counts for participants with <1500/mm^3 at pretreatment"|12 weeks||||participants|||Number
2823610|NCT00357110|Primary|Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)|Number of patients event-free|12 month period following randomisation||||Participants|||Number
2823611|NCT00357097|Secondary|"Change From Average Baseline Scores of Subscale Sleep Quantity (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks"||Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
2823612|NCT00357097|Secondary|"Change From Average Baseline Scores of Subscale Sleep Adequacy of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks"|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
2823636|NCT00357006|Secondary|Scores on Adverse Symptom Checklist at Trial Completion||Baseline and weeks 1, 2, 4, 6, 8|||||||
2823637|NCT00357006|Secondary|Scores on MADRS at Trial Completion||Baseline and week 8|||||||
2823638|NCT00357006|Secondary|Cognitive Performance (RBANS Scores)||baseline and week 8|||||||
2823614|NCT00357097|Secondary|"Change From Average Baseline Score of Subscale of Somnolence in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks"|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
2823615|NCT00357097|Secondary|"Percentage of Participants With Much Improved or Very Much Improved on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks"|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score range: 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5- minimally worse, 6-much worse, to 7-very much worse.|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Percentage of Participants|||Number
2823616|NCT00357097|Secondary|Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Percentage of Participants|||Number
2823617|NCT00357097|Secondary|Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Baseline, Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)|||Score on a Scale||Standard Deviation|Mean
2823618|NCT00357097|Secondary|Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 91 and Placebo 34. High/Low BDI scores for this population were 46/2.|||Score on a Scale||Standard Deviation|Mean
2823619|NCT00357097|Secondary|Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 90 and Placebo 31.|||Score on a Scale||Standard Deviation|Mean
2823620|NCT00357097|Secondary|Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 93 and Placebo 34|||Score on a Scale||Standard Deviation|Mean
2823621|NCT00357097|Secondary|"Percentage of Participants (Responder) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18)"|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29|||Percentage of Participants|||Number
2823622|NCT00357097|Secondary|"Percentage of Participants (Responder) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline"|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).|||Percentage of Participants|||Number
2823623|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15.|||Percentage of Participants|||Number
2823675|NCT00356759|Secondary|Secondary Efficacy Outcomes: Thromboembolic Events|Number of patients with any objectively verified, independently adjudicated thromboembolic event during the 12-month study period|12 months|Intention to treat|||participants|||Number
2823624|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).|||Percentage of Participants|||Number
2823625|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with BDI scores>=21: Ropinirole 75 and Placebo 28. High/Low BDI scores for this population were 46/2.|||Score on a Scale||Standard Deviation|Mean
2823626|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). High/Low BDI scores for this population were 46/2.|||Score on a Scale||Standard Deviation|Mean
2823627|NCT00357097|Secondary|Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54(severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15: Ropinirole 93 and Placebo 33|||Score on a Scale||Standard Deviation|Mean
2823628|NCT00357097|Secondary|Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low HAM-D scores for this population were 27/5.|||Score on a Scale||Standard Deviation|Mean
2823629|NCT00357097|Secondary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29. The high/Low scores for the mITT population were 32/11.|||Score on a Scale||Standard Deviation|Mean
2823630|NCT00357097|Primary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low scores for this population were 32/11.|||Score on a Scale||Standard Deviation|Mean
2823631|NCT00357032|Secondary|Toxicity Summary|Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 and above toxicities possibly, probably or definitely related to treatment.|Up to 1 year||||participants|||Number
2823632|NCT00357032|Secondary|Duration of Response|From time of documented treatment response (CR or PR) until progression of death. Complete Response (CR): Repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia. Partial Resonse (PR): requires the same hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to a post-treatment value of 5% to 25% in the bone marrow aspirate. (If the pre-treatment blast percentage was 50-100%, this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49%, this must decrease by at least half to a value greater than 5%.) A value ≤ 5% is also considered a PR if Auer rods are present.|Up to 1 year|There were no formal CRs or PRs seen among the first cohort of 12 patients, resulting in the study's closure. As a result data were not collected.The study was completed as planned and stopped due to futility as written per protocol. It was not terminated prematurely as accrual proceeded per protocol.||||||
2823633|NCT00357032|Secondary|Overall Survival|Survival endpoints will be summarized by the method of Kaplan-Meier|Up to 1 year||||Months||95% Confidence Interval|Median
2823634|NCT00357032|Primary|Complete Response Rate|Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles. Per International Working Group criteria: Complete Response (CR): Repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia|Up to 1 year||||percentage of subjects|||Number
2823635|NCT00357006|Secondary|Change in Hormone Levels Over Trial Duration||Baseline and weeks 1, 4 and 8.|||||||
2823639|NCT00357006|Primary|Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.|Baseline and week 8||||units on a scale||Standard Deviation|Mean
2823640|NCT00356993|Secondary|Count of Participants Not Smoking|7-day point prevalence of abstinence at 12 months post treatment|12 months post treatment|||||||
2823641|NCT00356993|Primary|Count of Participants Not Smoking|7-day point prevalence of abstinence at 6 months post treatment|6 months post treatment|Not every participant completed the 6mo and 12mo follow-up surveys|||Participants|||Count of Participants
2823642|NCT00356915|Secondary|Clinical Improvement Compared to Placebo|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.~The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.~0 = Clinical Cure: No evidence of onychomycosis.~1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months|Intent to treat (ITT)|||percentage of participants|||Number
2823643|NCT00356915|Secondary|Clinical Improvement of the Target Toenail|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.~The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.~0 = Clinical Cure: No evidence of onychomycosis.~1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months||||percentage of participants|||Number
2823644|NCT00356915|Primary|Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules|The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.|12 months|Intent to treat (ITT).|||Percentage of participants|||Number
2823645|NCT00356915|Primary|Clinical and Mycological Cure of Target Toenail|"This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.~Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail."|1 year|Intent to treat (ITT).|||Percentage of participants|||Number
2823646|NCT00356889|Secondary|Duration of Response|Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).|From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years|There were 6 patients with a confirmed Partial Response.|||months||95% Confidence Interval|Median
2823647|NCT00356889|Secondary|Time to Disease Progression|Estimated using the method of Kaplan-Meier (1958).|From registration to documentation of disease progression, assessed up to 3 years||||months||95% Confidence Interval|Median
2823648|NCT00356889|Secondary|Survival Time|Estimated using the method of Kaplan-Meier (1958).|From registration to death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2823649|NCT00356889|Primary|Number of Confirmed Tumor Responses.|"Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions.~A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint."|After 6 courses of treatment. Each course lasts 28 days.||||participants|||Number
2823650|NCT00356863|Other Pre-specified|Blood Pressure|The pooled mean of 3 blood pressure measurements taken during the interview|1 year follow up||||mm Hg||95% Confidence Interval|Mean
2823651|NCT00356863|Secondary|MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.|MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL.|1 year|The N for this outcome is the number of patients for whom there are follow-up data after one year.|||Scores on a scale||Standard Deviation|Mean
2823652|NCT00356863|Other Pre-specified|Physical Activity|"Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max. Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake"|1 year|All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire|||patients|||Number
2823676|NCT00356759|Primary|Primary Outcome Measure: Time in Therapeutic Range|Percent time in therapeutic range calculated by linear interpolation.|12 months|Intention to treat population|||percentage of time||Standard Deviation|Mean
2823653|NCT00356863|Other Pre-specified|Depression & Anxiety|Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention)|1 year|All patients who completed the Hospital Anxiety and Depression Scale (HADS)|||HADS score||Standard Deviation|Mean
2823654|NCT00356863|Other Pre-specified|Employment Status|Number of patients fully employed in each arm|1 year||||patients|||Number
2823655|NCT00356863|Other Pre-specified|Lifestyle Habits (i.e. Smoking)||1 year||||patients|||Number
2823656|NCT00356863|Other Pre-specified|Anthropometric Measures|Measurements of body mass index (BMI)|1 year||||kg/m^2||95% Confidence Interval|Mean
2823657|NCT00356863|Other Pre-specified|Medical Service Utilization|Visits to the emergency department during the year following CABG surgery|1 year||||ER visits|||Number
2823658|NCT00356863|Other Pre-specified|Biochemical Markers|glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation.|1 year||||mg/dl||95% Confidence Interval|Mean
2823659|NCT00356863|Other Pre-specified|Cardiovascular Morbidity|All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0).|1 year|All patients who were exposed to the educational intervention at baseline and who were contacted a year later and gave information regarding participation in cardiac rehabilitation during the follow up year.|||events|hospitalizations||Number
2823660|NCT00356863|Primary|Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups|The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups.|1 year|All patients alive at 1-year follow up who gave information on participation in cardiac rehabilitation programs (CRPs) at any time during the year following surgery (and before follow up assessment). This information was obtained via a face-to-face interview or by telephone interview.|||participants|||Number
2823661|NCT00356811|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the start of study medication until 28 days after the last dose (up to Study Week 381)|ITT Population|||Participants|||Number
2823662|NCT00356811|Secondary|Overall Survival|Overall survival is defined as the interval between the date of treatment start and the date of death due to any cause. For participants who did not die, follow-up was censored as the date of last contact. For participants who did not die, follow-up was censored at the date of last contact.|From the date of the first dose until the date of death due to any cause (up to Week 86)|ITT Population|||weeks||95% Confidence Interval|Median
2823663|NCT00356811|Secondary|Progression-free Survival, as Assessed by the IRC and the Investigator|Progression-free survival is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to any cause, whichever occurs first. Participants who did not progress in their disease were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)|ITT Population|||weeks||95% Confidence Interval|Median
2823664|NCT00356811|Secondary|Time to Progression, as Assessed by the IRC and the Investigator|Time to progression is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to breast cancer, whichever occurs first. Participents who did not progress or die were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population|||weeks||95% Confidence Interval|Median
2823665|NCT00356811|Secondary|Time to Response, as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||Weeks||95% Confidence Interval|Median
2823666|NCT00356811|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||weeks||95% Confidence Interval|Median
2823667|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||Weeks||95% Confidence Interval|Median
2823668|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the IRC|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.|||weeks||95% Confidence Interval|Median
2823669|NCT00356811|Secondary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per RECIST. The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the Investigator. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|ITT Population|||Participants|||Number
2823670|NCT00356811|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|Intent-to-Treat (ITT) Population: all participants who received study medication.|||Participants|||Number
2823671|NCT00356759|Secondary|Patients With Dose Changes|Number of patients with at least one change of maintenance dose during the 12-month study period|12 months|Intention to treat|||participants|||Number
2823672|NCT00356759|Secondary|Number of Extreme INR Results|Number of INRs outside the range 1.5-4.4|12 months|Intention to treat|||Number of tests|||Number
2823673|NCT00356759|Secondary|Secondary Safety Outcome: Number of Patients With Extreme INR Results|Secondary safety outcome is number of patients with at least one INR below 1.5 or above 4.4|12 months|Intention to treat|||participants|||Number
2823674|NCT00356759|Secondary|Secondary Safety Outcome: Major Bleeding|Number of patients with any objectively verified, independently adjudicated major bleeding event during the 12-month study period. Major bleeding was defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria|12 months|Intention to treat|||participants|||Number
2823677|NCT00356603|Secondary|Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate|The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.|Up to 2 months|FAS Population.|||Percentage of participants|||Number
2823678|NCT00356603|Secondary|Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product|"The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was Was the kit product easy to use?, question 2 was Do you want to use the kit product in the future? and question 3 was Do you consider that the kit product is necessary for the treatment of your illness?. The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented."|Up to 2 months|FAS Population.|||Participants|||Count of Participants
2823679|NCT00356603|Primary|Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)|Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.|30 minutes or 60 Minutes after each administration|Full Analysis Set (FAS) Population included patients who self-administered the study product and have at least one efficacy data.|||Percentage of participants||95% Confidence Interval|Number
2823680|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale|Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2|||Units on a scale||Full Range|Mean
2823681|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Erosion Subscale|Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2|||Units on a scale||Full Range|Mean
2823682|NCT00356590|Secondary|Change From Baseline to Year 2 in Total Sharp Score|Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2|||Units on a scale||Full Range|Mean
2823683|NCT00356590|Primary|Death|Death of the participant on study up to 30 days after the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
2823684|NCT00356590|Secondary|Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12|Percent improvement in the duration of morning stiffness from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823685|NCT00356590|Secondary|Percent Improvement in C-Reactive Protein From Baseline to Month 12|Percent improvement in C-reactive protein from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823686|NCT00356590|Secondary|Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12|Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823687|NCT00356590|Secondary|Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12|Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823688|NCT00356590|Secondary|Percent Improvement in HAQ DI From Baseline to Month 12|Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823689|NCT00356590|Secondary|Percent Improvement in Swollen Joint Count From Baseline to Month 12|Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823690|NCT00356590|Secondary|Percent Improvement in Tender Joint Count From Baseline to Month 12|Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823691|NCT00356590|Secondary|Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12|"Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from no pain (0 cm) to severe pain (10 cm)."|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823867|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at One Hour.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hour|All participants included.|||participants|||Number
2823692|NCT00356590|Secondary|Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and Month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823693|NCT00356590|Secondary|Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12|||Percent change||Standard Deviation|Mean
2823694|NCT00356590|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.|Up to 8 years|All participants who received at least one dose of etanercept|||Standardized incidence rate||95% Confidence Interval|Mean
2823695|NCT00356590|Secondary|ACR70 Response at Month 12|American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12|||Participants|||Number
2823696|NCT00356590|Secondary|ACR50 Response at Month 12|American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12|||Participants|||Number
2823697|NCT00356590|Secondary|ACR20 Response at Month 12|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12|||Participants|||Number
2823698|NCT00356590|Secondary|Dosing Period|Duration of etanercept dosing|Up to 8 years|All participants who received at least one dose of etanercept|||Days||Standard Deviation|Mean
2823699|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Events per 100 patient-years|||Number
2823700|NCT00356590|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
2823701|NCT00356590|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
2823702|NCT00356590|Primary|Malignancy|Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participants|||Number
2823703|NCT00356590|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Lymphomas per 100 participant-years|||Number
2823704|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Events per 100 participant-years|||Number
2823705|NCT00356590|Primary|Total Exposure-Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Deaths per 100 participant-years|||Number
2823706|NCT00356590|Primary|Total Exposure-Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Malignancies per 100 participant-years|||Number
2823707|NCT00356590|Secondary|ACR20 Response at Month 3|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)|Baseline and month 3|All enrolled participants who received at least one dose of etanercept and had available data at month 3|||Participants|||Number
2823708|NCT00356590|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.|Up to 8 years|All enrolled participants who received at least one dose of etanercept|||Participant-years|||Number
2823709|NCT00356525|Secondary|Time to Treatment Failure||baseline to stopping treatment (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.|||months||Standard Deviation|Mean
2823710|NCT00356525|Secondary|Duration of Response||time of response to progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.|||months||Standard Deviation|Mean
2823711|NCT00356525|Secondary|Time to Progressive Disease||baseline to measured progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.|||months||Standard Deviation|Mean
2823712|NCT00356525|Secondary|Overall Survival|Overall survival is the number of participants who were alive when the trial was terminated.|baseline to trial termination (17.5 months)|Number of randomized participants in each category.|||participants alive|||Number
2823713|NCT00356525|Primary|Objective Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to time of response (up to 17.5 months)|Number of randomized participants in each category.|||participants|||Number
2823714|NCT00356434|Secondary|DVT Prevention|positive DVT on ultrasound|up to 3 months|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
2823715|NCT00356434|Primary|Patient Compliance|Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded|for 1-7 days during hospitalization|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
2823716|NCT00356434|Primary|Comfort Level|Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).|once during first 7 days of hospitalization||||units on a scale||Full Range|Mean
2823717|NCT00356421|Other Pre-specified|Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||scores on scale|||Number
2823718|NCT00356421|Secondary|Change in Fasting Lipids From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl||Standard Deviation|Mean
2823719|NCT00356421|Other Pre-specified|Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||scores on scale|||Number
2823720|NCT00356421|Secondary|Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl|||Number
2823721|NCT00356421|Secondary|Change From Baseline in Prandial Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||IU||Standard Deviation|Mean
2823722|NCT00356421|Secondary|Change From Baseline in Basal Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||International Units (IU)||Standard Deviation|Mean
2823723|NCT00356421|Secondary|Change From Baseline in Body Mass Index|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||kilograms per meter squared (kg/m2)||Standard Deviation|Mean
2823724|NCT00356421|Secondary|Change From Baseline in Body Weight|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||kg||Standard Deviation|Mean
2823725|NCT00356421|Secondary|Change From Baseline in Insulin Antibody Levels|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||ml||Standard Deviation|Mean
2823726|NCT00356421|Secondary|Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl||Standard Deviation|Mean
2823727|NCT00356421|Secondary|Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||mg/dl||Standard Deviation|Mean
2823728|NCT00356421|Secondary|Change From Baseline in FPG|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||milligrams per deciliter (mg/dl)||Standard Deviation|Mean
2823729|NCT00356421|Secondary|Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
2823730|NCT00356421|Secondary|Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
2823731|NCT00356421|Secondary|Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
2823732|NCT00356421|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||percent|||Number
2823733|NCT00356408|Secondary|Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.|Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.|Week 34 in this study|All subjects in the the Intent to Treat (ITT) population are included in this analysis.|||percentage of subjects|||Number
2823734|NCT00356408|Primary|Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)|Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.|During this study (maximum 122 weeks)|All subjects in the the Intent to Treat (ITT) population are included in this analysis.|||subjects|||Number
2823735|NCT00356369|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|At Year 1, Year 2, Year 3, Year 4 and Year 5|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823736|NCT00356369|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823737|NCT00356369|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to 31 Days after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823738|NCT00356369|Secondary|Number of Subjects With AEs Resulting in Emergency Rooms Visits||From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823739|NCT00356369|Secondary|Number of Subjects With Rash||From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823740|NCT00356369|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 up to 6 Months after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823741|NCT00356369|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2823742|NCT00356369|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2823743|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||μg/mL||95% Confidence Interval|Geometric Mean
2823744|NCT00356369|Secondary|Number of Subjects With Anti-PS Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||Participants|||Count of Participants
2823745|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point..|||μg/mL||95% Confidence Interval|Geometric Mean
2823746|NCT00356369|Secondary|Number of Subjects With Anti-PS Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.|||Participants|||Count of Participants
2823747|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||μg/mL||95% Confidence Interval|Geometric Mean
2823748|NCT00356369|Secondary|Number of Subjects With Anti-PS Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||Participants|||Count of Participants
2823749|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 5|The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.|||Titer||95% Confidence Interval|Geometric Mean
2823750|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 5|The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.|||Participants|||Count of Participants
2823751|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 4|The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.|||Titer||95% Confidence Interval|Geometric Mean
2823752|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 4|The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.|||Participants|||Count of Participants
2823753|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||Titer||95% Confidence Interval|Geometric Mean
2823754|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 3|The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.|||Participants|||Count of Participants
2823755|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.|||Titre||95% Confidence Interval|Geometric Mean
2823756|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 2|The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.|||Participants|||Count of Participants
2823757|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||Titer||95% Confidence Interval|Geometric Mean
2823758|NCT00356369|Secondary|Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.|At Year 1|The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.|||Participants|||Count of Participants
2823759|NCT00356369|Secondary|Concentration of Anti-TT Antibodies|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2823760|NCT00356369|Secondary|Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2823761|NCT00356369|Secondary|Concentration of Anti-PS Antibodies|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2823762|NCT00356369|Secondary|Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies|The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2823763|NCT00356369|Secondary|rSBA Antibody Titers|Antibody titers are presented as Geometric Mean Titers (GMTs).|Prior to and 1 Month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titer||95% Confidence Interval|Geometric Mean
2823764|NCT00356369|Secondary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.|Prior to and 1 Month after vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from whom immunogenicity data were available.|||Participants|||Count of Participants
2823765|NCT00356369|Primary|Occurrence of Any Grade 3 Systemic Symptoms|"Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm).~General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C."|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.|||Participants|||Count of Participants
2823766|NCT00356369|Primary|Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)|Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.|One month post vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Percentage of subjects||95% Confidence Interval|Number
2823767|NCT00356304|Secondary|Medication Attitudes||Measured at Month 5|||||||
2823768|NCT00356304|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.~0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms."|Measured at Month 5||||units on a scale||Standard Error|Mean
2823769|NCT00356304|Secondary|Treatment Retention||Measured at Month 5|||||||
2823770|NCT00356304|Primary|Medication Adherence, as Measured by Electronic Pill Container|Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.|Measured immediately post-treatment and at Months 2 and 5 months follow-ups|We used an ITT with LOCF. These figures represent outcomes at 5 months.|||Percentage of Days||Standard Error|Mean
2823771|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823772|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823773|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823774|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823775|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823776|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823777|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823778|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823779|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823780|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data|||units on a scale||95% Confidence Interval|Mean
2823781|NCT00356265|Primary|α1-adrenoceptor Vasoreactivity With Endogenous ADMA||up to 8 hours|The main goal of the study was to compare vasoreactivity across the three groups. Given the fact that we struggled to recruit matched hypertensive and normotensive control population, we were not able to achieve the goals of the study and therefore, ADMA levels were not measured.||||||
2823782|NCT00356265|Primary|α1-adrenoceptor Vasoreactivity With L-NMMA|"Vasoreactivity is defined as Forearm blood flow, dose response curve; ml per minute per log of phenylephrine, or FABF ml/min/logPE;~The x axis is the ml/min value and the y axis is the log Phenylephrine concentration."|up to 8 hours|Based on the data from the 12 participants, and the early termination, no analysis was performed on the two hypertensive participants' data.|||ml/min x 1/log[PE]||Standard Error|Mean
2823784|NCT00356200|Secondary|Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 4 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4|||mm||Standard Deviation|Mean
2823785|NCT00356187|Secondary|Clinical Outcome Measurements|Ventilator days, ICU and hospital days, and in-hospital mortality|ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
2823786|NCT00356187|Secondary|Alterations in Neuroendocrine and Immunoinflammatory Measurements|blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction|ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
2823787|NCT00356187|Secondary|Changes in Protein Metabolism Measurements|net nitrogen balance, fat-free mass, and fat mass|ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
2823788|NCT00356187|Primary|Change in REE vs. Controls||ICU admission date to ICU discharge or death|Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.||||||
2823789|NCT00356148|Secondary|Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).||1 month||||Monetary unit in Turkish Liras||Standard Error|Mean
2823790|NCT00356148|Primary|Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).||1 month|Analysis was intent-to-treat|||participants|||Number
2823791|NCT00356135|Secondary|Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.|End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug|Safety Population - all randomized participants.|||Participants|||Number
2823792|NCT00356135|Secondary|Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week|Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.|1 week after randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||correlation coefficient|||Number
2823793|NCT00356135|Secondary|Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||percent residual platelet aggregation||Standard Deviation|Mean
2823794|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event|Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.|End of 14 day open label|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event.|||percent maximum platelet aggregation (%)||Standard Deviation|Mean
2823795|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||percent maximum platelet aggregation (%)||Standard Deviation|Mean
2823796|NCT00356135|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)|Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|1 week after first dose of randomized study drug|The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.|||percent maximum platelet aggregation (%)||Standard Error|Least Squares Mean
2823797|NCT00356122|Secondary|Number of Participants With Treatment-related Toxicities|"Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator.~AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator."|From baseline up to 30 days after treatment discontinuation|All participants who received at least one dose of study treatment|||Participants|||Number
2823798|NCT00356122|Secondary|Overall Survival (OS)|OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.|Baseline to OS (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Months||95% Confidence Interval|Median
2823799|NCT00356122|Secondary|Time-to-treatment Failure (TTF)|"Treatment failure was defined as an event which lead to the participant's withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy.~TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method."|Baseline to treatment failure (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Months||95% Confidence Interval|Median
2823800|NCT00356122|Secondary|Objective Response Rate|"Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR.~CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks."|Baseline to CR or PR (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Percentage of participants||95% Confidence Interval|Mean
2823801|NCT00356122|Primary|Progression-free Survival (PFS)|"PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first.~Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline to PFS (up to 24 months after the first treatment)|All participants registered to receive study treatment|||Months||95% Confidence Interval|Median
2823802|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||mL||Standard Error|Mean
2823803|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||mL||Standard Error|Mean
2823804|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||grams||Standard Error|Mean
2823805|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||mL||Standard Error|Mean
2823806|NCT00356057|Secondary|Mortality Rate||At six months post-procedure|Subjects enrolled|||percentage of participants analyzed|||Number
2823807|NCT00356057|Secondary|Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations||At six months post-procedure|Subjects successfully implanted with investigational system.|||percentage of participants analyzed|||Number
2823808|NCT00356057|Secondary|Changes in New York Heart Association (NYHA) Classification|"The purpose is to evaluate the change in the participant's NYHA classification.~There are four NYHA classes:~Class I: Patients with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Change from baseline to six months post-procedure|"Subjects with paired baseline and 6-month NYHA classification data. The outcome of Improved at least 1 Class represents a numerically higher NYHA class at baseline than at 6 months (e.g. NYHA class III at baseline changed to NYHA class II at 6 months)."|||Participants|||Count of Participants
2823809|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction||Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month echocardiography data.|||percent||Standard Error|Mean
2823810|NCT00356057|Secondary|Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months|Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. This outcome was calculated as QOL score at baseline minus QOL score at 6 months. Therefore, a positive change in QOL score represents an improvement in quality of life, while a negative change in QOL score represents a worsening.|Change from baseline to six months post-procedure|Subjects with paired baseline and 6-month QOL data. A positive score represents improvement from baseline to 6-months.|||units on a scale||Standard Error|Mean
2823811|NCT00356057|Secondary|Change in Six-minute Walk Test||Change from baseline to 6 months post-procedure|Subjects with paired baseline and 6-month six-minute walk test data.|||Meters||Standard Error|Mean
2823868|NCT00355394|Primary|The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours|All participants included.|||participants|||Number
2823812|NCT00356057|Primary|Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.|At six months post-procedure||||Participants|||Count of Participants
2823813|NCT00356057|Primary|Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.|At six months post-procedure||||Participants|||Count of Participants
2823814|NCT00356057|Primary|Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months|Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))|Change from baseline to six months post-procedure|Patients included in this analysis are those patients with complete six minute walk test and Quality of Life data at both baseline and the six-month follow-up.|||Percent Change||Standard Error|Mean
2823815|NCT00356031|Secondary|Disease Free Survival|The median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.|3 years||||Months||Full Range|Median
2823816|NCT00356031|Secondary|Distant Recurrence|The number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.|3 years||||Participants|||Count of Participants
2823817|NCT00356031|Secondary|Local Control Rate|The number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.|3 years||||Participants|||Count of Participants
2823818|NCT00356031|Secondary|Average Change in Blood Flow, Blood Volume,and Permeability Surface Area|The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.|3 years||||Percent Reduction||Full Range|Mean
2823819|NCT00356031|Secondary|Change in Median Microvessel Density (MVD) After Bevacizumab Alone|The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone|baseline and 3 years||||percentage of change in MVD||95% Confidence Interval|Median
2823820|NCT00356031|Primary|Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.|The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.|3 years||||participants|||Number
2823821|NCT00355914|Primary|Oswestry Disability Index|Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).|Baseline, 3, 6, 12, 18, and 24 months post-treatment.|An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.|||units on a scale||Standard Deviation|Mean
2823822|NCT00355914|Primary|Average Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|Baseline, 3, 6, 12, 18, and 24 months post-treatment||||units on a scale||Standard Error|Mean
2823823|NCT00355797|Primary|Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)|Patients completing the orthostatic test in all three pacing modes and that had at least 80% pacing during the test in the CLS and R pacing modes are included in the analysis. The mean pulse pressure is provided.|within 45 days of enrollment||||mmHg||Standard Deviation|Mean
2823824|NCT00355797|Secondary|Change in 6-minute Walk Test Distance|Change in number of 10 foot repetitions between baseline and 12-month visit were examined.|baseline and 12 months|Subjects completing the 6 minute walk at both enrollment and at the 12-month visit were included in intention to treat analysis.|||repetitions||Standard Deviation|Mean
2823825|NCT00355797|Secondary|Change in New York Heart Association (NYHA) Class|Number of subjects with improved, no change, or worsened NYHA classification at the 12-month visit, as compared to baseline. NYHA classifications (I to IV) are used to assess the various stages of heart failure, with Class I relating to mild heart failure and Class IV relating to severe heart failure.|baseline and 12 months|Subjects with NYHA classifications at both enrollment and at the 12-month visit were analyzed using intention to treat.|||participants|||Number
2823826|NCT00355797|Secondary|Cardiac Symptoms|Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.|12 months|All subjects answering questions about current cardiac symptoms at the 12-month visit were included in this intention to treat analysis.|||participants|||Number
2823827|NCT00355797|Secondary|Atrial Fibrillation (AF) Burden|AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.|12 months|Percentage of atrial burden was collected for subjects utilizing dual chamber pacing that completing a 12-month follow-up visit.|||percentage of atrial beats||Standard Deviation|Mean
2823828|NCT00355797|Secondary|Mode Reprogramming|Number of subjects with device reprogramming from dual (atrial and ventricular pacing) to single chamber (ventricular pacing only) or from single (ventricular pacing only) to dual chamber (atrial and ventricular pacing) during the 12 month follow-up.|12 months|Subjects completing at least one follow-up visit were analyzed using intention to treat.|||participants|||Number
2823829|NCT00355797|Secondary|Change in Quality of Life|Change in Quality of life (QOL) score was determined from baseline to the 12 month follow-up visit. The QOL utilized the physical functioning scale of the SF-36 v2, in which a higher score indicates a better health perception. Best possible score was 57.03 while the worst possible score was 14.94.|baseline and 12 months|Subjects completing a QOL at both baseline and 12 month follow-up were included in an intention to treat analysis.|||score||Standard Deviation|Mean
2823830|NCT00355797|Primary|Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)|Six-minute walk test and sweep test results for subjects completing tests in all three pacing modes and requiring at least 80% pacing during both tests in the CLS and R pacing modes. The mean composite of repetitions (six minute walk plus sweep) are presented.|within 45 days of enrollment|Patients requiring at least 80% pacing during both tests in the CLS and accelerometer pacing modes are included.|||repetitions||Standard Deviation|Mean
2823831|NCT00355784|Primary|Changes in Fat-free Mass||2 weeks||||kg||Standard Error|Mean
2823832|NCT00355784|Primary|Changes in Fat Mass||2 weeks||||kg||Standard Error|Mean
2823833|NCT00355784|Primary|2 Week Skeletal Muscle Protein Synthesis|after an overnight fast|2 weeks|per protocol|||skeletal muscle protein%/hour||Standard Error|Mean
2823834|NCT00355784|Primary|Whole Body Protein Turnover After 2 Week Intervention|whole body proteolytic rate (leucine Ra)|2 weeks|per protocol|||µmol/kg fat free mass/min||Standard Error|Mean
2823835|NCT00355784|Primary|Lipolytic Rate||2 weeks|per protocol|||µmol/min||Standard Error|Mean
2823836|NCT00355784|Primary|Baseline Skeletal Muscle Protein Synthesis|after an overnight fast|baseline|per protocol|||skeletal muscle protein%/hour||Standard Error|Mean
2823837|NCT00355784|Primary|Baseline Whole Body Protein Turnover|Whole body proteolytic rate (Leucine Ra)|baseline|per protocol|||μmol/kg fat free mass/min)||Standard Error|Mean
2823838|NCT00355784|Primary|Changes in Body Weight||2 weeks|per protocol|||kg||Standard Error|Mean
2823839|NCT00355784|Primary|24 Hour Average Plasma Growth Hormone Concentration||2 weeks|per protocol|||ng/mL||Standard Error|Mean
2823840|NCT00355706|Primary|Oswestry Disability Index|Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).|24 months||||units on a scale||Standard Deviation|Mean
2823841|NCT00355706|Other Pre-specified|Opioid Intake|Opioid intake(morphine equivalence mg)|24 months||||mg/day||Standard Deviation|Mean
2823842|NCT00355706|Primary|Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|2 years||||units on a scale||Standard Deviation|Mean
2823843|NCT00355615|Secondary|Percent Change in Non-HDL-C/HDL-C|Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
2823844|NCT00355615|Secondary|Percent Change in TC/HDL-C|Percent change in the ratio of TC/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
2823845|NCT00355615|Secondary|Percent Change in LDL-C/HDL-C|Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment|After 12 week of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
2823846|NCT00355615|Secondary|Percent Change in ApoB/ApoA-1|Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
2823847|NCT00355615|Secondary|Percent Change in Apolipoprotein B (ApoB)|Percent change in ApoB after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
2823848|NCT00355615|Secondary|Percent Change in Apolipoprotein A-1 (ApoA-1)|Percent change in ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||mean percent change||Standard Deviation|Mean
2823849|NCT00355615|Secondary|Percent Change in Total Cholesterol (TC)|Percent change from baseline in total cholesteral after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
2823869|NCT00355368|Secondary|Number of Participants With an Failed First Intubation Attempts|defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt|within the first 90 sec following the start of induction||||participants|||Number
2823850|NCT00355615|Secondary|Percent Change in Triglycerides (TG)|Percent change in tryglycerides (TG) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
2823851|NCT00355615|Secondary|Percent Change in Non-HDL-C at 12 Weeks|Percent change in non-HDL-C at 12 weeks|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
2823852|NCT00355615|Secondary|Percent Change in HDL-C|Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percent change||Standard Deviation|Mean
2823853|NCT00355615|Secondary|Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment|Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||Percent of Participants|||Number
2823854|NCT00355615|Secondary|Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)|Percent change from baseline in LDL-C after six week of treatment|6 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percentage||Standard Deviation|Mean
2823855|NCT00355615|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase|Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.|||percentage||Standard Deviation|Mean
2823856|NCT00355472|Secondary|Time to Progression (TTP)|TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.|Baseline to response||||days||Full Range|Median
2823857|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).|t1/2|||hours||Standard Deviation|Mean
2823858|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0-7 days post final dose|AUC0-7 days|||ng·h/mL||Standard Deviation|Mean
2823859|NCT00355472|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.|0-7 days post final dose||||ng/mL||Standard Deviation|Mean
2823860|NCT00355472|Secondary|Antitumor Effect|The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).|50 days||||participants|||Number
2823861|NCT00355472|Primary|Maximum Tolerated Dose (MTD)|The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.|28 days||||mg/kg|||Number
2823862|NCT00355472|Primary|Incidence of Dose-Limiting Toxicities (DLTs)|Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.|28 days||||participants|||Number
2823863|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours||||NRS Score||Standard Deviation|Mean
2823864|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours||||NRS Score||Standard Deviation|Median
2823865|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hours|All participants included.|||NRS Score||Standard Deviation|Mean
2823866|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at 24 Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours||||participants|||Number
2823870|NCT00355368|Secondary|Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.|"The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.~Units: measure on a scale"|during laryngoscopy and the first minute after completion of intubation||||score points||Standard Deviation|Mean
2823871|NCT00355368|Secondary|Time to Completion of Intubation|time interval between the injection of the induction agent and the first appearance of endtidal CO2|time interval between the injection of the induction agent and the first appearance of endtidal CO2||||seconds||Standard Deviation|Mean
2823872|NCT00355368|Secondary|Haemodynamic Sequelae of Intubation|any new haemodynamic alteration requiring immediate intervention|between start of induction sequence and 5 min after completion of intubation|||||||
2823873|NCT00355368|Primary|Number of Participants Exhibiting Desaturation >5%|decrease of >5% in oxygen saturation measured continuously using pulse oxymetry|at any time between the start of the intubation sequence and 2min after the completion of intubation|ITT|||participants|||Number
2823874|NCT00355342|Secondary|Percent Change From Baseline in BMD at the Total Hip|BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.|Baseline and Week 26, 52, 78, 104, 130, and 156|Safety Population. Only those participants available at the specified time points were analyzed.|||Percent Change||Standard Error|Mean
2823875|NCT00355342|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4|BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.|Baseline and Week 26, 52, 78, 104, 130, and 156|The Safety population - Safety population was defined as all randomized participants who are at least 50% compliant with taking study drug and have a post-Baseline BMD scan. Only those participants available at the specified time points were analyzed.|||Percent Change||Standard Error|Mean
2823876|NCT00355199|Secondary|Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14||Through completion of salvage therapy|||||||
2823877|NCT00355199|Secondary|Toxicity|Percentage of participants with at least one reported episode of CTC grade III or IV toxic events|Through therapy completion an average of 8 months||||percentage of participants|||Number
2823878|NCT00355199|Secondary|Overall Survival|OS was defined from the time of the study entry to death as a result of any cause or date of the last follow-up visit|36 months from end of therapy||||percentage of OS at 3 years follow-up||95% Confidence Interval|Number
2823879|NCT00355199|Secondary|Disease Free Survival|DFS was defined from the time of documentation of CR to time to relapse or death as a result of lymphoma or acute toxicity of treatment or date of the last follow-up visit|36 months from end of therapy||||percentage of DFS at 3 years follow-up||95% Confidence Interval|Number
2823880|NCT00355199|Secondary|Complete Remission|Clinical response was assessed by complete restaging according to Cheson criteria. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-86, 2007|Through therapy completion an average of 8 months||||participants|||Number
2823881|NCT00355199|Primary|Event Free Survival|EFS was defined from the time of the study entry to any treatment failure including disease progression or discontinuation of treatment for any reason or date of the last follow-up visit|36 months from end of therapy||||percentage of EFS at 3 years follow-up||95% Confidence Interval|Number
2823882|NCT00355147|Secondary|Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)~Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%."|Baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.|||participants|||Number
2823883|NCT00355147|Secondary|Medication (Statins) for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).~Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%."|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.|||participants|||Number
2823884|NCT00355147|Secondary|Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment|"Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)~Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%"|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.|||participants|||Number
2823885|NCT00355147|Primary|Self-Efficacy to Manage Stroke Symptoms|Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.|6 months|We hypothesized the intervention group would report significantly greater self-efficacy to manage stroke symptoms than the control group. Level of significance was set to .05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, & time.|||units on a scale||Standard Deviation|Mean
2823886|NCT00355147|Primary|Stroke Specific Health Related Quality of Life|"Stroke Specifc, Health Related Quality of Life (SSQoL)~Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.~Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.~We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05."|6 months for (SSQoL) and 3 months for Perceived Energy Subdomain|We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, and time.|||units on a scale||Standard Deviation|Mean
2823887|NCT00355134|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with non-missing data at each time point."|||units on a scale||Standard Deviation|Mean
2823888|NCT00355134|Secondary|Percentage of Participants Relapse-free up to End of Study|Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|From Baseline until the end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||percentage of participants||95% Confidence Interval|Number
2823889|NCT00355134|Secondary|Percentage of Participants Relapse-free up to Month 24|Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2823890|NCT00355134|Secondary|Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||percentage of participants||95% Confidence Interval|Number
2823891|NCT00355134|Secondary|Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||percentage of participants||95% Confidence Interval|Number
2823892|NCT00355134|Secondary|Change From Baseline in Lesion Volume at Month 24 (Core Phase)|Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.|Baseline and Month 24|Full analysis set for whom data were available. N=the number of patients with non-missing baseline and post-baseline values.|||mm^3||Standard Deviation|Mean
2823893|NCT00355134|Secondary|Number of Gadolinium-enhanced T1 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with evaluable MRI data for the specified time point."|||lesions||Standard Deviation|Mean
2823946|NCT00354744|Primary|Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy|Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy.|From enrollment to up to 2 years|Percentage of patients experiencing a grade 3/4/5 toxicity in a course.|||percentage of patients||95% Confidence Interval|Number
2823894|NCT00355134|Secondary|Number of New or Newly Enlarged T2 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.|From Baseline until Month 48|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with MRI data available for the specified time period."|||lesions||Standard Deviation|Mean
2823895|NCT00355134|Secondary|Percent Change From Baseline in Brain Volume|Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with data available for the specified time period."|||percent change||Standard Deviation|Mean
2823896|NCT00355134|Secondary|Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.~A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).~ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|From Baseline until end of study (up to approximately 54 months).|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.|||relapses per year||95% Confidence Interval|Number
2823897|NCT00355134|Primary|Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.~A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).~ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|24 months|Full analysis set, including all patients who were randomized and took at least one dose of study drug.|||relapses per year||95% Confidence Interval|Number
2823898|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2823899|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
2823900|NCT00355121|Other Pre-specified|Geometric Mean Titers Against Poliovirus After IPOL Vaccination.|Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.|Day 30 post-vaccination|Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2|||Titers||95% Confidence Interval|Geometric Mean
2823901|NCT00355121|Secondary|Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine|Fever was defined as a maximum oral temperature of ≥ 100.4ºF.|Day 0 through Day 7 post-vaccination at Visit 1|Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2823902|NCT00355121|Secondary|Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination|Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.|||Titers||95% Confidence Interval|Geometric Mean
2823903|NCT00355121|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1|Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).|Day 30 post-vaccination 1|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)|||EU/mL||95% Confidence Interval|Geometric Mean
2823904|NCT00355121|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)|||Titers||95% Confidence Interval|Geometric Mean
2824022|NCT00353704|Secondary|Morphine (Opioid) Consumption Cumulated|"Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as  cumulated opioid consumption (milligram)"|240 minutes||||mg||Standard Deviation|Mean
2823905|NCT00355121|Primary|Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination|Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)|||Participants|||Number
2823906|NCT00355082|Secondary|The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)|Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.|Baseline and entire Continuation phase (24 Weeks)|All participants who entered the Continuation Phase|||participants|||Number
2823907|NCT00355082|Secondary|Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase|Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.|Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase|All participants who began the Continuation Phase|||percent change in seizures||Full Range|Median
2823908|NCT00355082|Secondary|Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase|The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn|The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators|||participants|||Number
2823909|NCT00355082|Secondary|Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)|Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.|Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators|||percent change in seizures||Full Range|Median
2823910|NCT00355082|Secondary|Percentage of Participants Meeting Escape Criteria in the Treatment Phase|The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.|Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators|||percentage of participants|||Number
2823911|NCT00355082|Secondary|Time to Discontinuation in the Treatment Phase|Time (days) until the participant discontinued the study|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug|||Days||Standard Deviation|Mean
2823912|NCT00355082|Secondary|The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators|||percentage of participants|||Number
2823913|NCT00355082|Primary|The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)|All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators|||percentage of participants|||Number
2823914|NCT00355030|Secondary|Bone Age|Bone age measured using the X-Ray of left hand and wrist.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.|||years||Standard Deviation|Mean
2823915|NCT00355030|Secondary|Percentage of Children With Normal Adult Height SDS|Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.|||percentage of participants|||Number
2823916|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.|||standard deviation score||Standard Deviation|Mean
2823917|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Predicted Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height [calculated using the Bayley-Pinneau method based on height and bone age] for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.|||standard deviation score||Standard Deviation|Mean
2823918|NCT00355030|Secondary|Difference Between Adult Height SDS and Target Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height [calculated as (mother's height (SDS) + father's height (SDS))/2] for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End of Study (up to 9 years)|All participants who received who reached final height.|||standard deviation score||Standard Deviation|Mean
2823919|NCT00355030|Secondary|Height SDS|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.|||standard deviation score||Standard Deviation|Mean
2823920|NCT00355030|Secondary|Height Velocity|Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.|||centimeter per year||Standard Deviation|Mean
2823921|NCT00355030|Primary|Adult Height Standard Deviation Score (SDS)|The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.|||standard deviation score||Standard Deviation|Mean
2823922|NCT00355030|Primary|Number of Participants With One or More Drug-related Adverse Events|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population).|||participants|||Number
2823923|NCT00354978|Primary|Median Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.|From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months|Analysis per protocol.|||Months||95% Confidence Interval|Median
2823924|NCT00354913|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.|69 Months|Intent-to-treat|||percentage of participants|||Number
2823925|NCT00354913|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.|Intent-to-treat|||months||95% Confidence Interval|Median
2823926|NCT00354913|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.|Intent-to-treat|||months||95% Confidence Interval|Median
2823927|NCT00354913|Primary|Progression-free Survival at 6 Months|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2823964|NCT00354341|Secondary|Left Ventricular End Systolic Volume Index (LVESVI)|LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2).|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||mL/m^2||Standard Deviation|Mean
2823928|NCT00354887|Primary|Number of Participants With Overall Response|Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.|Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses|Analysis was intent-to-treat; One patient developed an acute flare of Crohn’s disease after one cycle of study treatment and was removed from study without undergoing restaging scans.|||participants|||Number
2823929|NCT00354835|Secondary|Incidence of Bladder Dysfunction|Number of patients with a summary score greater than 8.5|3-6 years after enrollment|470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.|||Participant|||Number
2823930|NCT00354835|Secondary|Event Free Survival (EFS) by PAX Status||4 years|Only eligible patients who were tested for their fusion status and PAX partners.|||Probability||95% Confidence Interval|Number
2823931|NCT00354835|Secondary|Toxicity With GSTA1 and CYP2C9 Genotypes|Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes.|During the study|The analysis was abandoned due to low incidence of toxicity. Data were not collected.||||||
2823932|NCT00354835|Secondary|Toxicity With CYP2B6 Genotypes|Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes.|During the study|The analysis was abandoned due to low incidence of toxicity. Data were not collected.||||||
2823933|NCT00354835|Secondary|Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype|Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.|Weeks 4-9 (the first exposure to VI)|Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.|||Counts|||Number
2823934|NCT00354835|Secondary|Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15|4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study)|4 years|421 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 15.|||Probability||95% Confidence Interval|Number
2823935|NCT00354835|Secondary|Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4|4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study).|4 years|452 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 4.|||Probability||95% Confidence Interval|Number
2823936|NCT00354835|Secondary|Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC|The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.|Up to 43 weeks|Number of patients with specific adverse events.|||participants|||Number
2823937|NCT00354835|Secondary|Incidence of Toxicity|Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.|Up to 15 weeks||||Probability||95% Confidence Interval|Number
2823938|NCT00354835|Secondary|Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison|Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70.|4 years|17 ineligible participants were excluded.|||Probability||95% Confidence Interval|Number
2823939|NCT00354835|Secondary|Local Failure|Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.|2 years|17 ineligible participants were excluded.|||Proportion of participants||95% Confidence Interval|Number
2823940|NCT00354835|Secondary|Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison|Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65.|4 years|17 ineligible participants were excluded.|||Probability||95% Confidence Interval|Number
2823941|NCT00354835|Primary|Overall Survival (OS)|Probability of being alive after 4 years in the study.|4 years||||Probability||95% Confidence Interval|Number
2823942|NCT00354835|Primary|Response Rate (RR)|Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR.|Reporting Period 1 (Weeks 1 - 15)||||Proportion||95% Confidence Interval|Number
2823943|NCT00354835|Primary|Event Free Survival (EFS)|Probability of no relapse, secondary malignancy, or death after 4 year in the study|4 years||||Probability||95% Confidence Interval|Number
2823944|NCT00354770|Primary|Massachusetts General Hospital Hairpulling Scale|There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.|Baseline and final visit after 12 weeks||||units on a scale||Standard Deviation|Mean
2823945|NCT00354744|Secondary|Percentage of Patients Event Free at 4 Years Following Study Entry|Event-free survival: Time to recurrence, second malignancy, or death as a first event, estimated from a Kaplan Meier curve|4 years|All eligible patients|||Percentage of patients||95% Confidence Interval|Number
2823947|NCT00354744|Primary|Number of Patients With Complete or Partial Response Assessed by RECIST Criteria|"Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the measurable mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as non-measurable. Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning."|Protocol week 6 evaluation|All eligible patients with protocol week tumor assessment (N=102)|||percentage of participants|||Number
2823948|NCT00354679|Primary|Evaluation of Safety and Toxicity|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years||||participants|||Number
2823949|NCT00354640|Secondary|Change in Serum Estradiol Levels|The change in serum concentrations of estradiol at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.|||pmol/l||Full Range|Median
2823950|NCT00354640|Primary|Change in Blood Concentrations|The change in blood concentrations of anastrozole at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.|||ng/ml||Full Range|Median
2823951|NCT00354614|Primary|Sensitivity and Specificity|Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater|Simultaneous single night recording||||percentage|||Number
2823952|NCT00354601|Primary|Objective Tumor Response|The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines|8 weeks|unable to measure due to failure to complete||||||
2823953|NCT00354601|Secondary|Quality of Life|comparison of treatment end to pre entry and day 1 of each treatment cycle.|Pre-entry, day 1, treatment end|neither patient completed study||||||
2823954|NCT00354601|Secondary|Number of Participants With Grade 3 or Higher Toxicity|summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)|tracked during incomplete treatment period|||participants|||Number
2823955|NCT00354601|Secondary|Time to Progression|Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter|Evaluated every 8 weeks during treatment|unable to analyze due to failure to complete treatment or study||||||
2823956|NCT00354484|Primary|Reported Adverse Events||anytime between baseline and end of study or time to intervention|||||||
2823957|NCT00354484|Primary|Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL||anytime between baseline and end of study or time to intervention||||participants|||Number
2823958|NCT00354432|Secondary|Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.|12 weeks|Participants with baseline and 12 week quality of life data.|||units on a scale||Standard Error|Least Squares Mean
2823959|NCT00354432|Primary|Hot Flash Symptom Severity Score|The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.|12 weeks|All randomized participants were analyzed in a repeated measures mixed model. This allowed inclusion of all study participants.|||percent of baseline score||Standard Error|Least Squares Mean
2823960|NCT00354341|Secondary|Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL||Week 26 up to Week 64|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2823961|NCT00354341|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||percentage of LVEDV||Standard Deviation|Mean
2823962|NCT00354341|Secondary|Fractional Myocardial Shortening (FS)|FS was calculated as: ([LVEDD - LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here “n”= participants who were evaluable for each category, for respective arm groups.|||percentage of LVEDV||Standard Deviation|Mean
2823963|NCT00354341|Secondary|Left Ventricular End Diastolic Volume Index (LVEDVI)|LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||mL/m^2||Standard Deviation|Mean
2824139|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
2823965|NCT00354341|Primary|Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15|LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 - (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2).|Baseline, Month 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||g/m^2||Standard Deviation|Mean
2823966|NCT00354224|Secondary|Progression-free Survival||Every 6 weeks through study completion for up to about 18 weeks|data was not collected for this endpoint.||||||
2823967|NCT00354224|Secondary|Number of Adverse Events||From the start of study treatment through study completion for up to about 18 weeks||||Serious Adverse Events|||Number
2823968|NCT00354224|Primary|Response Rate as Determined by RECIST.|Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 6 weeks through study completion for up to about 18 weeks|this data was not collected.||||||
2823969|NCT00354172|Secondary|Chimerism After Double Umbilical Cord Blood Transplant (UCBT)|Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient).|Day 21, Day 100, 6 Months|1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate.|||Percentage of Engrafted Cells||Full Range|Median
2823970|NCT00354172|Secondary|Number of Participants (Patients) With Successful Natural Killer Cell Expansion|Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population|10-13 Days Post Infusion||||Participants|||Number
2823971|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 24 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|2 Years Post transplant||||Participants|||Number
2823972|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 12 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|1 Year Post Transplant||||Participants|||Number
2823973|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 24 Months|Number of patients who died after receiving treatment within 24 months post transplant.|2 years post-transplant||||Participants|||Number
2823974|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 12 Months|Number of patients who died after receiving treatment within 12 months post transplant.|1 year Post Transplant||||Participants|||Number
2823975|NCT00354172|Secondary|Number of Participants (Patients) With Chronic Graft-Versus-Host Disease|The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival.|Day 100 through 1 Year Post Transplant||||Participants|||Number
2823976|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 post transplant||||Participants|||Number
2823977|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 Post Transplant||||Participants|||Number
2823978|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Platelet Engraftment|Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.|1 Year Post Transplant||||Participants|||Number
2823979|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Neutrophil Engraftment|"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)."|Day 42 Post Transplant||||Participants|||Number
2823980|NCT00354172|Secondary|Number of Participants (Patients) Who Died Due to Transplant.|Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.|6 Months Post Transplant||||Participants|||Number
2823981|NCT00354172|Secondary|Number of Patients Who Were Disease-free and Alive at 24 Months|Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.|24 Months Post transplant||||Participants|||Number
2823982|NCT00354172|Secondary|Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months|Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.|12 Months Post transplant||||Participants|||Number
2823983|NCT00354172|Primary|Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months|Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.|6 Months Post Transplant|One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.|||Participants|||Number
2823984|NCT00354159|Secondary|Characterize Arrhythmic Events|The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm|12 months post implant|All 399 subjects successfully implanted with the Chronicle ICD were included in the analysis.|||VT/VF episodes per subject month||95% Confidence Interval|Number
2823985|NCT00354159|Secondary|Characterize Quality of Life at Baseline and 12-month Visit|The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.|baseline to 12 months post implant|Subjects were required to respond to the baseline and 12-month follow-up visit to be included in the analysis.|||scores on a scale||Standard Deviation|Mean
2823986|NCT00354159|Secondary|Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)|The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin|Implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing.|||percentage of subjects||95% Confidence Interval|Number
2823987|NCT00354159|Secondary|Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)|Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.|implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing as part of their ICD implant procedure.|||Percentage of subjects with waveforms||95% Confidence Interval|Number
2823988|NCT00354159|Secondary|Characterize Renal Function at the Baseline and 12-month Visit|Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.|baseline to 12 months post implant|Subjects were required to have creatinine values available at the baseline and 12-month visit to be included in the analysis of this objective.|||mL/min/1.73 m^2||Standard Deviation|Mean
2823989|NCT00354159|Secondary|Characterize Distance Walked in Six Minutes|The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.|baseline to 12 months post implant|Subjects were required to complete the 6-minute hall walk test at both the baseline and 12-month visit to be included in the analysis of this objective.|||distance walked in 6-minutes (meters)||Standard Deviation|Mean
2823990|NCT00354159|Secondary|Characterize NYHA Functional Class|The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.|baseline to 12 months post implant|Subjects were required to have an NYHA functional class assessment at the baseline and 12-month follow-up visit to be included in this analysis.|||percentage of subjects|||Number
2823991|NCT00354159|Secondary|Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.|12 months post implant|All Control Arm subjects with at least 90 days of pressure data available during the 12-month randomized follow-up period.|||ePAD mm Hg||Standard Deviation|Mean
2823992|NCT00354159|Secondary|Characterize Intracardiac Pressure|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.|12 months post implant|At least 90 days of ePAD data were required for each subject during the 12-month randomized period to be included in the analysis.|||ePAD mm Hg||Standard Deviation|Mean
2823993|NCT00354159|Secondary|Characterize Medication Usage|The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.|12 months post implant|All randomized subjects.|||Medication changes per subject month|||Number
2823994|NCT00354159|Secondary|Characterize Subject Survival|Death from any cause during the 12-month randomization period|12 months post implant|All randomized subjects.|||number of deaths|||Number
2823995|NCT00354159|Secondary|Characterize Randomized Days Alive Out of Hospital|Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.|12 months post implant|All randomized subjects.|||Days||Standard Deviation|Mean
2823996|NCT00354159|Secondary|Characterize Health Resource Utilization|Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.|12 months post implant|All randomized subjects.|||percentage of randomized days||Full Range|Mean
2824011|NCT00353977|Primary|Cellular Immune Response in Vaccine Recipients|Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating cytomegalovirus (CMV)-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors.|Day 45|11 subjects were CMV seropositive and 3 subjects were seronegative.|||participants|||Number
2824140|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
2823997|NCT00354159|Secondary|Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.|"The definitions of worsened, improved, and unchanged are as follows:~Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF.~Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score.~Unchanged: Subject is neither worsened nor improved."|12 months post implant|All randomized follow-up from all randomized subjects were included.|||Percent of Subjects|||Number
2823998|NCT00354159|Secondary|Relative Risk of All-cause Events|All-cause events were defined as hospitalizations, hospitalizations <24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.|12 months post-implant|All randomized follow-up from all randomized subjects|||All cause event rate per year||95% Confidence Interval|Mean
2823999|NCT00354159|Secondary|Freedom From All Cause Death or Heart Failure Hospitalization|Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period|12 months post-implant|All randomized subjects|||Number of subjects meeting endpoint|||Number
2824000|NCT00354159|Secondary|Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group|The rate of CV-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized follow-up for all randomized subjects.|||Cardiovascular related events per year||95% Confidence Interval|Mean
2824001|NCT00354159|Secondary|Cumulative Days in the Hospital for Heart Failure|The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.|12 months post-implant|All follow-up from all randomized subjects were included in this analysis.|||Percent days in hospital||Full Range|Median
2824002|NCT00354159|Primary|Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group|The rate of HF-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized subjects|||Heart failure related events per year||95% Confidence Interval|Mean
2824003|NCT00354159|Primary|Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant|A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.|6 months post implant|All subjects with an attempted implant of the Chronicle IHM system were included in this analysis. At the time the study stopped, there was only one subject with an attempted Chronicle IHM implant. Thus this objective was not analyzed.|||Percent of Chronicle IHM subjects||Full Range|Mean
2824004|NCT00354159|Primary|Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.|A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.|Within 6 months post-implant|All 406 subjects with an attempted implant of the Chronicle ICD system.|||Percentage of Chronicle ICD Subjects||95% Confidence Interval|Number
2824005|NCT00354107|Secondary|Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)|NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|At baseline and weeks 5 and 11|These data were not collected to assess this study aim and will never be collected.||||||
2824006|NCT00354107|Secondary|Development of Human Antichimeric Antibodies by Using ELISA Method|Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|Change from baseline to week 11|These data were not collected to assess this study aim and will never be reported.||||||
2824007|NCT00354107|Secondary|CD30 Concentrations Levels as Assessed by ELISA|Summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals. Although the limited sample size precludes formal hypothesis testing, exploratory analysis of the association between soluble CD30 levels and PK parameters and response will be performed.|At baseline|These data were not collected to assess this study aim and will never be reported.||||||
2824008|NCT00354107|Secondary|Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods||At baseline, at weeks 1, 2, 5, 6, and 11|These data were not collected to assess this study aim and will never be reported.||||||
2824009|NCT00354107|Primary|Response|Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive.|Week 4||||percent|||Number
2824010|NCT00354029|Primary|NRS Pain = Numeric Rating Scale (0-10)|The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.|24 hours||||Units on a scale||Standard Deviation|Mean
2824012|NCT00353873|Secondary|Number of Participants Who Achieved WC Asthma|WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as 'WC', 'Not Controlled' or 'Unevaluable'. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period.|Week 5 up to Week 12|ITT Population. Only participants with analyzable data at the indicated time point were assessed.|||Participants|||Number
2824013|NCT00353873|Secondary|Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma|TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as 'TC', 'Well Controlled' (WC), 'Not Controlled' or 'Unevaluable'. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period.|Week 5 up to Week 12|ITT Population. Only participants with analyzable data at the indicated time point were assessed.|||Participants|||Number
2824014|NCT00353873|Primary|Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population|PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.|Baseline; Week 1 up to Week 12|PP Population: All participants in the ITT Population who did not have any protocol violations which could impact treatment effect. Only participants with analyzable data at the indicated time point were assessed.|||L/min||Standard Error|Least Squares Mean
2824015|NCT00353873|Primary|Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population|PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.|Baseline; Week 1 up to Week 12|ITT Population: All participants randomized to treatment who received at least one dose of randomized study medication. Only participants with analyzable data at the indicated time point were assessed.|||Liters/Minute (L/min)||Standard Error|Least Squares Mean
2824016|NCT00353834|Secondary|Fourth Will be Changes in Insulin, Glucose, C-peptide, Lipids, and FFA Responses Following the MTT in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurement||Baseline and end of study|||||||
2824017|NCT00353834|Secondary|Third Will be the Changes in Markers of Endothelial Function, Inflammation, Fibrinolysis, and Oxidative Stress in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline||Baseline and end of study|||||||
2824018|NCT00353834|Secondary|Second Will be the Change in Arterial Stiffness, as Measured by PWA, in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements.||Baseline and end of study|||||||
2824019|NCT00353834|Secondary|First Will be the Changes in TNG Stimulated Arterial Dilation (Endothelial-independent) in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements|Trinitroglycerin (TNG) response evaluates endothelium independent vasodilation. The brachial artery was scanned before and 5 minutes after sublingual administration of 400 ug of trinitroglycerin. This was performed only at 4 hours following the test meal and fifteen minutes after completion of the FMD study to allow for the brachial artery to return to baseline. This was performed at both the baseline and 3 month visits.|Baseline and end of study||||Percentage dilation||Standard Deviation|Mean
2824020|NCT00353834|Primary|The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus.|Flow mediated dilation (FMD) of the brachial artery was measured at rest and during reactive hyperemia using a high-resolution 10.0 MHz linear array transducer and an HOI Ultramark 9 system. Reactive hyperemia was produced by inflating a pneumatic tourniquet on the forearm distal to the brachial artery to 50 mmHg above the systolic BP for 5 minutes, then deflating it . Brachial artery diameter was measured before inflation of the cuff and 1-2 minutes after cuff deflation and expressed as the percentage change. This protocol is described in detail elsewhere. This was performed fasting, 2, and 4 hours after the meal challenge at baseline and 3 months.|Baseline and End of Study||||Percentage dilation||Standard Deviation|Mean
2824021|NCT00353795|Primary|Mean Coronary Wall Thickness|Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).|n/a (cross sectional analysis)||||mm||Standard Deviation|Mean
2824023|NCT00353704|Primary|Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)|The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.|120 minutes after surgery||||Units on a scale||Standard Deviation|Mean
2824024|NCT00353652|Secondary|Sympathetic Baroreflex Sensitivity|slope relating percent change in SNA (% change in total activity from baseline) to diastolic BP.|3 months||||% change from baseline per mmHg||Standard Deviation|Mean
2824025|NCT00353652|Secondary|HOMA-IR|assessment of insulin resistance calculated by multiplying fasting plasma insulin (mU/l) with fasting plasma glucose (mmol/l) divided by 22.5.|3 months|unequal randomization by chance|||mU/l*mmol/l||Inter-Quartile Range|Median
2824026|NCT00353652|Secondary|Insulin|fasting plasma insulin|3 months||||mU/liter||Inter-Quartile Range|Median
2824027|NCT00353652|Secondary|24-hour Ambulatory Systolic Blood Pressure||Measured at 3 months||||mmHg||Standard Error|Mean
2824028|NCT00353652|Primary|Sympathetic Nerve Activity||Measured at 3 months||||bursts/min||Standard Error|Mean
2824029|NCT00353522|Primary|Percent Change From Baseline in HDL-C||Baseline and Week 24||||Percent Change||Standard Error|Least Squares Mean
2824030|NCT00353522|Secondary|Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity||Baseline and 48 Weeks||||percent change in pMOL/mcL/hr||Standard Error|Least Squares Mean
2824031|NCT00353522|Secondary|Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)||Baseline and 48 Weeks||||Percent change in mg/dL||Standard Error|Least Squares Mean
2824032|NCT00353522|Secondary|Change in Mesenteric Lymph Nodes||Baseline and 48 Weeks||||Number of Nodes|Number of Mesenteric Lymph Nodes||Number
2824033|NCT00353522|Secondary|Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass||Baseline and Weeks 24||||Percent change||Standard Error|Least Squares Mean
2824034|NCT00353522|Primary|Absolute Change From Baseline in HDL-C||Baseline and Week 24||||mg/dL||Standard Error|Least Squares Mean
2824035|NCT00353496|Secondary|Percentage of Patients Still Alive Based on Available Overall Survival Data|Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.|Randomisation to death or last visit, up to 321 weeks|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.|||percentage of participants|||Number
2824036|NCT00353496|Secondary|Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels||Week 12 to Week 96 (last visit)|Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis.|||percentage of participants|||Number
2824037|NCT00353496|Secondary|Change in the Global Health Status Quality of Life Assessment|Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12 to Week 96 (last visit)|Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment.|||score on a scale||Standard Error|Least Squares Mean
2824038|NCT00353496|Secondary|Pharmacokinetic Profile of Lanreotide|Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints|Week 4, 12, 24, 36, 48, 72, 96|Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide|||ng/mL||Standard Deviation|Mean
2824039|NCT00353496|Secondary|Percentage of Patients Alive & Without Disease Progression|Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.|Week 48 & 96|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.|||Percentage of participants|||Number
2824040|NCT00353496|Primary|Progression-Free Survival (PFS)|Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0|From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.|||Weeks||95% Confidence Interval|Median
2824041|NCT00353431|Secondary|Frequency of Hypokalaemia|Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)|during observation of 48 hours||||participants|||Number
2824042|NCT00353431|Secondary|Frequency of Severe Hypoglycaemia|Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours||||participants|||Number
2824043|NCT00353431|Secondary|Frequency of Hypoglycemia|absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours||||participants|||Number
2824044|NCT00353431|Secondary|Time to Reach the Target Range|Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).|24 h|Intension to treat|||hours||Standard Deviation|Mean
2824045|NCT00353431|Primary|Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours|Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)|48 h|Intension to treat|||hours||Standard Deviation|Mean
2824046|NCT00353418|Primary|Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia|Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.|Up to Week 72|The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.|||Percentage of participants|||Number
2824114|NCT00352417|Primary|Percent Cross-sectional Area of Macrophages in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody|12 weeks|Evaluable Population with histological sections available|||Percent Area||95% Confidence Interval|Mean
2824047|NCT00353418|Secondary|Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12|EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.|Week 12|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
2824048|NCT00353418|Secondary|Rapid Virological Response (RVR) by Week 4|RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.|Week 4|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
2824049|NCT00353418|Secondary|Relapse of Virological Response|Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.|Weeks 48 and 72|Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients.|||Percentage of participants|||Number
2824050|NCT00353418|Secondary|Virological Response at Weeks 4, 12 and 24|Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.|Weeks 4, 12 and 24|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
2824051|NCT00353418|Secondary|Virological Response at End of Treatment Period|Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.|Week 48|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
2824052|NCT00353418|Primary|Sustained Virological Response (SVR)|SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.|Week 72|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.|||Percentage of participants|||Number
2824053|NCT00353366|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that : results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Throughout the study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Participants|||Number
2824054|NCT00353366|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited Adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During 31 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Subjects|||Number
2824055|NCT00353366|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhea, fever, irritability, loss of appetite and vomiting.|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Subjects|||Number
2824056|NCT00353366|Primary|Number of Subjects Reporting Grade 2 or 3. Grade 2 : An AE Which Was Sufficiently Discomforting to Interfere With Normal Everyday Activities. Grade 3: an Unsolicited AE That Prevented Normal Everyday Activity.|Grade 2 or 3 assessed include fever, vomiting and diarrhea|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.|||Subjects|||Number
2824057|NCT00353301|Secondary|Overall Survival|For all subjects who had not died at the time of statistical analysis, duration of survival will was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the magnitude of the treatment effect as described for progression-free survival.|Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.|||Weeks||95% Confidence Interval|Median
2824115|NCT00352365|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.|Up to 5 years|Eligible patients who began protocol therapy|||percentage of participants||95% Confidence Interval|Number
2824058|NCT00353301|Primary|Progression-free Survival|Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma.|Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.|||Weeks||95% Confidence Interval|Median
2824059|NCT00353275|Secondary|Hypoglycemia||Duration of hospital stay|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
2824060|NCT00353275|Secondary|Organ Failure||Duration of hospital stay|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
2824061|NCT00353275|Primary|Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)||Duration of hospital stay|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
2824062|NCT00353275|Primary|Infectious Morbidity||Duration of hospital stay, an average of 2 weeks|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.||||||
2824063|NCT00353262|Secondary|Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous).|Up to 28 days after last chemotherapy administration|All 36 participants who received at least one dose of capecitabine.|||Participants|||Number
2824064|NCT00353262|Secondary|Number Of Participants With Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during the study were also to be reported as AEs.|Approximately 3 Years (up to 28 days after the last intake of study medication)|All 36 participants who received at least one dose of capecitabine.|||Participants|||Number
2824065|NCT00353262|Secondary|Clearance of Total And Free Platinum|CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour).|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||mL/Hr||Geometric Coefficient of Variation|Geometric Mean
2824066|NCT00353262|Secondary|Volume of Distribution at Steady State (VSS) of Total And Free Platinum|VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||mL||Geometric Coefficient of Variation|Geometric Mean
2824067|NCT00353262|Secondary|T1/2 Beta of Total And Free Platinum|T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||hour||Geometric Coefficient of Variation|Geometric Mean
2824068|NCT00353262|Secondary|Cmax of Total And Free Platinum|Cmax is defined as maximum observed analyte concentration of Total And Free Platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2824069|NCT00353262|Secondary|AUC0-last of Total And Free Platinum|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum.|pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
2824134|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824135|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824070|NCT00353262|Secondary|AUC0-infinity for Total Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
2824071|NCT00353262|Secondary|Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL)|t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||hour||Geometric Coefficient of Variation|Geometric Mean
2824072|NCT00353262|Secondary|Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)|Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2824073|NCT00353262|Secondary|AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
2824074|NCT00353262|Secondary|AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL)|AUC0-infinity represents the area under the concentration-time curve of the analytes (5'-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5'-deoxy-5-fluorocytidine (5'-DFCR), which is then converted to 5'-DFUR, and then catalytically activated to 5-FU.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
2824075|NCT00353262|Primary|AUC0-inf for Free Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity.|Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL * hr||Geometric Coefficient of Variation|Geometric Mean
2824076|NCT00353262|Primary|Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR)|AUC0-infinity represents the area under the concentration-time curve of the analyte (5'-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5'-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.|||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
2824077|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Percentage change||Standard Deviation|Mean
2824078|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|24 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Percentage change||Standard Deviation|Mean
2824136|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824137|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824138|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824079|NCT00353119|Secondary|Number of Adverse Events|Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.|28 weeks|Patients that crossed over from placebo to etanercept are included in the Etanercept group. The placebo group only included adverse events from the first 12 weeks prior to the crossover. The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Adverse Events|||Number
2824080|NCT00353119|Primary|Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover|"Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.|||Percentage change||Standard Deviation|Mean
2824081|NCT00352911|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 56|Mean log change in HIV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.|Baseline (Day 1) to Day 56||||copies/mL on log scale||Standard Deviation|Log Mean
2824082|NCT00352885|Secondary|Genetic Polymorphisms||Screening and After Cycle 4 (up to 14 weeks)|Genetic polymorphisms were not analyzed due to the small sample size and insufficient funds.||||||
2824083|NCT00352885|Secondary|Hamilton Depression Rating Scale (HAM-D) Score|Hamilton Depression Rating Scale (HAM-D) is a 21-item, observer-rated scale which quantifies the severity of depressive symptoms, including depressed mood, loss of interest in usually pleasurable activities, insomnia, anorexia, fatigue, weight loss, and psychomotor retardation or agitation. Participants rate the severity of their symptoms on a scale of 0-2 or 0-4 (depending on the item), where 0 means that the symptom is absent. Total scores are calculated by summing the first 17 items for a total score between 0 and 50. For this study a score of 0-6 indicates a normal state, a score of 7-17 indicates mild depression, a score of 18-24 indicates moderate depression, and a score of greater than 25 indicates severe depression. The HAM-D was administered at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants completing the HAM-D at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||units on a scale||Standard Error|Mean
2824084|NCT00352885|Secondary|Plasma Concentrations of Cortisol|Cortisol is a steroid hormone made in the adrenal glands in response to fear or stressful situations. A typical reference range is 6-23 micrograms/deciliter (mcg/dL) from blood drawn in the morning. Low levels of cortisol can indicate Addison's disease or a problem with the pituitary gland, while high levels may indicate tumors of the adrenal gland, among other illnesses, or increased stress. Chronic elevation of cortisol is associated with reduced immune function and increased risk of heart disease. IL-2 treatment stimulates the release of cortisol and this stimulation is dose dependent (rising as the dose of IL-2 increases) and tends to increase further with repeated exposure to IL-2. Blood was drawn for measuring cortisol at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants with cortisol measurements at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||mcg/dL||Standard Error|Mean
2824085|NCT00352885|Secondary|Plasma Concentrations of Interleukin 6 (IL-6)|Immune system functioning was assessed by measuring plasma concentrations of interleukin 6 (IL-6). IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, in patients with advanced or metastatic cancer, and is also implicated in mood disorders. IL-2 treatments are associated with increased IL 6 levels, in a dose response manner. IL-6 values in healthy individuals are generally less than 16 pg/ml. Blood was drawn for measuring IL-6 at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants with IL-6 measurements at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||pg/ml||Standard Error|Mean
2824086|NCT00352885|Secondary|Plasma Concentrations of Adrenocorticotropic Hormone (ACTH)|Adrenocorticotropic hormone (ACTH) is a stress hormone that is synthesized by the pituitary in response to corticotropin-releasing hormone (CRH). ACTH stimulates adrenal cortisol production. ACTH levels vary throughout the day and are highest between 6am and 8am. A typical reference range is 10-50 picograms per milliliter (pg/ml) from blood drawn in the morning. Low levels of ACTH can indicate adrenal insufficiency (including adrenal cancers) while high levels may indicate several diseases or stress. IL-2 treatment stimulates the release of ACTH and this stimulation is dose dependent (rising as the dose of IL-2 increases) and tends to increase further with repeated exposure to IL-2. Blood was drawn for measuring ACTH at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments.|Screening and Cycles 1 - 4 (up to 14 weeks)|The population in this analysis includes participants with ACTH measurements at the indicated study visit. Participants withdrew or were terminated from the study early depending on their ability to continue IL-2 treatment.|||pg/ml||Standard Error|Mean
2824087|NCT00352885|Primary|Number of IL-2 Treatments Tolerated|The mean number of IL-2 doses tolerated (out of the possible 60 total doses) are presented for each study arm. The standard high dose regimen of IL-2 includes 15 doses per cycle. The dose of IL-2 is reduced, or treatment is stopped entirely, if the side effects become severe. This analysis includes the total number of doses taken at the end of Cycle 4, by all participants who began the trial, regardless of how many cycles each participant completed.|Cycle 4 (up to 12 weeks of IL-2 treatment)||||IL-2 treatments||Standard Deviation|Mean
2824088|NCT00352846|Primary|Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months|The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score >= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores <= -2.5 indicate osteoporosis.|From baseline to 12 Months|BMD data available on 53 evaluable participants upon treatment completion.|||Percentage Change of BMD||Standard Deviation|Mean
2824089|NCT00352794|Primary|Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)|Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death.|6 months||||Participants|||Count of Participants
2824090|NCT00352781|Secondary|Smoking Cessation|7-day point prevalence of abstinence|12 months after end of treatment|Number of participants who completed the 12m follow-up|||percentage of participants abstinent|||Number
2824091|NCT00352781|Primary|Smoking Cessation|7-day point prevalence of abstinence|6 months after end of treatment|Number of participants that completed the 6m follow-up (i.e. per protocol)|||percentage of participants abstinent|||Number
2824092|NCT00352755|Secondary|Overall Survival||Median follow-up was 32 months||||months||Full Range|Median
2824093|NCT00352755|Secondary|Progression-free Survival||Median follow-up was 32 months||||months||Full Range|Median
2824094|NCT00352755|Secondary|Number of Participants Who Experience Surgical Complications Associated With This Regimen||Median follow-up was 32 months||||participants|||Number
2824095|NCT00352755|Secondary|Progression Rate|-Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median follow-up was 32 months||||percentage of participants|||Number
2824096|NCT00352755|Primary|Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events||30 days after end of treatment||||participants|||Number
2824097|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Pneumonitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0.|||participants|||Number
2824098|NCT00352690|Primary|Overall Survival (OS)|OS = time from patient registration to death of all causes|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown expiration dates were censored at the date of last clinical contact.|||months||95% Confidence Interval|Median
2824099|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Esophagitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0|||participants|||Number
2824100|NCT00352690|Secondary|Response Rates|Overall best response using RECIST 1.0|4 years||||participants|||Number
2824101|NCT00352690|Secondary|Failure-free Survival (FFS)|The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown event dates were censored at the date of last clinical contact.|||months||95% Confidence Interval|Median
2824102|NCT00352690|Secondary|Failure-free Survival (FFS) Rate|"The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)~Estimated using Kaplan Meier"|6 months|Participants with unknown event dates were censored at the date of last clinical contact.|||percentage of participants|||Number
2824103|NCT00352690|Primary|Overall Survival (OS) Rate|"OS = time from patient registration to death of all causes~Estimated using Kaplan Meier"|6 months|Participants with unknown expiration dates were censored at the date of last clinical contact.|||percentage of participants|||Number
2824104|NCT00352664|Primary|Sedation Mean Scores at 1-Week|"Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing not drowsy and 10 representing worst possible drowsiness."|Baseline and Day 7|Analysis was intention to treat (ITT), and population analyzed was that treated. Study closed early due to low patient accrual and insufficient supply of drug. No patients were randomized to Placebo Arm.|||Scores on a Scale||Standard Deviation|Mean
2824105|NCT00352612|Primary|Clinical Improvement at the 48-72 Hour Clinical Follow-up|Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.|48-72 hour clinical follow-up||||participants|||Number
2824106|NCT00352534|Secondary|Incidence of Renal Failure|Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up|During follow-up|Very low risk patients that have metachronous relapse.|||Incidents|||Number
2824107|NCT00352534|Secondary|Incidence of Contralateral Kidney Lesions|Number of contralateral kidney lesions during follow-up.|During follow-up|Very low risk patients treated by nephrectomy and observation only.|||Lesions|||Number
2824108|NCT00352534|Primary|Overall Survival (OS) Probability|Probability of being alive after 4 years in the study.|4 years|Eligible very low risk or standard risk patients|||Probability||95% Confidence Interval|Number
2824109|NCT00352534|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 4 year in the study.|4 years|Eligible very low risk or standard risk patients|||Probability||95% Confidence Interval|Number
2824110|NCT00352417|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)||Baseline and 12 weeks|Evaluable population with both baseline and visit 8 results|||mg/L||95% Confidence Interval|Least Squares Mean
2824111|NCT00352417|Secondary|Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine||Baseline and 12 Weeks|Evaluable Population|||Percent Change||95% Confidence Interval|Geometric Mean
2824112|NCT00352417|Secondary|Change From Baseline in Whole Blood Leukotriene B4 Production||Baseline and 12 weeks|Evaluable Population|||pg/ml||95% Confidence Interval|Least Squares Mean
2824113|NCT00352417|Secondary|Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue|12 weeks|Evaluable Population with histological sections available|||Percent Area||95% Confidence Interval|Mean
2824116|NCT00352365|Secondary|Total Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.|Up to 5 years|Eligible patients who began protocol therapy|||percentage of participants||95% Confidence Interval|Number
2824117|NCT00352365|Secondary|Cytogenetic Abnormalities|Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.|Up to 5 years||||Number of abnormalities||Full Range|Median
2824118|NCT00352365|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2824119|NCT00352118|Secondary|Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824120|NCT00352118|Secondary|Swallowing Ability - Quality of Life Scores|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).|Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824121|NCT00352118|Secondary|Time to Treatment Failure|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.|Number of Days from Complete or Partial Response to First Date of Recurrence or Progression|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824122|NCT00352118|Secondary|Number of Days With Disease Free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.|From Date of Registration to Date of First Treatment Failure or Death|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824123|NCT00352118|Secondary|Number of Days - Overall Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of death.|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824124|NCT00352118|Secondary|Number of Days With Progression-free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of first treatment failure or death.|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824125|NCT00352118|Primary|Number of Patients With Feeding Tube Dependency|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|at 12 months|All patients were non-evaluable - did not receive radiation dose per protocol.||||||
2824126|NCT00352105|Primary|Number of Participants With No Distant Metastatic Disease at 1 Year|1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.|1 year|5 early deaths were not evaluable|||participants|||Number
2824127|NCT00352105|Secondary|Number of Participants Who Completed 2 Years of Therapy||at 2 years after start of treatment||||participants|||Number
2824128|NCT00352105|Secondary|Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.|Complete response rate per RECIST Criteria (CTC V3)|3 years|5 early deaths were not evaluable|||participants|||Number
2824129|NCT00352105|Secondary|Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity|Any toxicity greater than or equal to Grade 1= mild|at 1 year after start of treatment||||participants|||Number
2824130|NCT00352105|Secondary|Number of Participants With No Local Disease at 1 Year|Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.|at 1 year after start of treatment|5 early deaths not evaluable|||participants|||Number
2824131|NCT00352105|Primary|Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival|To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival|at 1 year after start of treatment||||participants|||Number
2824132|NCT00352053|Secondary|Percentage of Participants With Virologic Failure Through Week 48|"Virologic failure was defined as either nonresponse or viral rebound.~Nonresponse (failure to achieve response). Response was defined as either~A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or~HIV-1 RNA < 400 copies/mL at 2 consecutive visits.~Viral rebound was defined as either~Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or~Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.~The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase."|Up to 48 weeks|ITT Analysis Set. 1 participant without time to respond [6 days of treatment]) was excluded. Nonresponders were counted as failures at time 0. Rebounders were counted as failures on study day of the first of 2 assessments meeting criteria. Otherwise, they were censored at last double-blind HIV measurement.|||Kaplan-Meier percentage|||Number
2824133|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method||||||
2824147|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
2824148|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
2824149|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
2824150|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824151|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824152|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824153|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824154|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||Percentage of participants|||Number
2824155|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
2824156|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||Percentage of participants|||Number
2824157|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Percentage|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
2824158|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824159|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824160|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824161|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824162|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824163|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 48 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824164|NCT00352053|Secondary|Change From Baseline to Week 24 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 24 weeks|ITT Analysis Set, missing = excluded method|||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
2824165|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Count|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
2824166|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Count||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
2824167|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Count||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
2824168|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Count||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
2824169|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Count||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method|||cells/mm^3||Inter-Quartile Range|Median
2824170|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Count||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method|||cells/mm3||Inter-Quartile Range|Median
2824171|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Count||Baseline to 48 weeks|ITT Analysis Set, missing = excluded method|||cells/mm3||Inter-Quartile Range|Median
2824172|NCT00352053|Secondary|Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count||Baseline to 24 weeks|ITT Analysis Set, missing = excluded method|||cells/mm3||Inter-Quartile Range|Median
2824173|NCT00352053|Secondary|Change From Baseline to Week 336 in HIV-1 RNA|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method||||||
2824179|NCT00352053|Secondary|Change From Baseline to Week 48 in HIV-1 RNA||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.|||log10 copies/mL||Inter-Quartile Range|Median
2824180|NCT00352053|Secondary|Change From Baseline to Week 24 in HIV-1 RNA||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the last observation carried forward (LOCF) method (includes the participant’s last available postbaseline value for missing data). The Placebo/TDF groups were analyzed using the missing = excluded method (participants with missing data were excluded from the analysis).|||log10 copies/mL||Inter-Quartile Range|Median
2824181|NCT00352053|Secondary|Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA|"DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed)."|Baseline to 48 weeks|ITT Analysis Set|||log10 copies/mL||Inter-Quartile Range|Median
2824182|NCT00352053|Primary|Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA|"DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed)."|Baseline to 24 Weeks|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least 1 dose of study drug, with baseline HIV-1 RNA ≥ 1000 copies/mL and who had no major eligibility criteria violations.|||log10 copies/mL||Inter-Quartile Range|Median
2824183|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Stage|Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up||||events|||Number
2824184|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Histology|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up||||events|||Number
2824185|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Gender|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up||||events|||Number
2824186|NCT00352027|Secondary|Toxicities With Grade >1|Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years|Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date.|||adverse events|||Number
2824187|NCT00352027|Secondary|3-year Local Failure-free Survival Probability|Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years||||probability||95% Confidence Interval|Number
2824188|NCT00352027|Secondary|3-year Overall Survival (OS) Probability|Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3-years||||probability||95% Confidence Interval|Number
2824189|NCT00352027|Secondary|3-year Event-free Survival (EFS) Probability|Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years||||probability||95% Confidence Interval|Number
2824190|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824263|NCT00352001|Primary|PHASE I: Maximum Tolerated Dose of Azacitidine|"Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard 3+3 design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here."|After 1 courses (1 months)|Participants in Phase I|||mg/m2 subcutaneously for 5 days|||Number
2824191|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824192|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824193|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824194|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824195|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824196|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824197|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824264|NCT00351936|Primary|Change From Baseline in Triglycerides|Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
2824198|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824199|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824200|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824201|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824202|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824203|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824204|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.|||beta coefficient||95% Confidence Interval|Number
2824228|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824205|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824206|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824207|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824208|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824209|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824210|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824211|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824267|NCT00351936|Primary|Change From Baseline in Fasting Total Cholesterol|Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
2824212|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824213|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824214|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824215|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824216|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824217|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824218|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824229|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824219|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824220|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824221|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824222|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824223|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824224|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824225|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824226|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824227|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824230|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824231|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824232|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824233|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824234|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824235|NCT00352027|Secondary|Patient Quality of Life (QoL), Symptom Distress Scale|"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824236|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Communication|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824237|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824238|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824248|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824239|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Worry|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824240|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824241|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824242|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Nausea|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824243|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824244|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824245|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824246|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824247|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824265|NCT00351936|Primary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
2824249|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824250|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.|||units on a scale||Standard Deviation|Mean
2824251|NCT00352027|Secondary|Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy||1, 2, 5, and 10 years post therapy|||||||
2824252|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Age|Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up||||events|||Number
2824253|NCT00352027|Secondary|Local and Distant Failure for Children Treated With Tailored-field Radiation|The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.|from first enrollment date up to 3 years follow-up||||probability that the event occurs||95% Confidence Interval|Number
2824254|NCT00352027|Secondary|Disease Failure Rate Within Radiation Fields|Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).|3 years||||proportion of participants||95% Confidence Interval|Number
2824255|NCT00352027|Primary|3-year Event-Free Survival Probability|The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.|3 years||||probability||95% Confidence Interval|Number
2824256|NCT00352001|Secondary|Overall Survival Among Patients With Complete Response|Time (in months) patients who achieved a complete response using the RECIST criteria were alive on study|After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months|Only patients with complete response|||months||Full Range|Median
2824257|NCT00352001|Primary|PHASE I: Maximum Tolerated Dose of Lenalidomide|"Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard 3+3 design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here."|After 1 courses (1 months)|Participants in Phase I|||mg orally for 21 days|||Number
2824258|NCT00352001|Secondary|Number of Patients That Experience Grade 3 or 4 Treatment Related Non-hematologic Adverse Events||After 7 months|Intention to Treat|||participants|||Number
2824259|NCT00352001|Secondary|Time to Relapse After Achieving Complete Response||After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months|Only patients with a complete response were analysed|||months||Full Range|Median
2824260|NCT00352001|Secondary|Time to Transformation to Acute Myeloid Leukemia or Death|Time (in months) patients took to evolve to myeloid leukemia or death after achieving a complete response using the RECIST criteria|After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months|Patients who achieved a complete response|||months||Full Range|Median
2824261|NCT00352001|Primary|PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)|"For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement)~Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones.~Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality.~Hematologic Improvement (HI) is defined as: red blood cell increase of >=1.5g/dL, a platelet response of >=30X10^9/L or by at least 100% for values starting <20X10^9/L, or a neutrophil response of at least 100% and absolute increase of >0.5X10^9/L"|After 7 courses (months)|Intention to Treat|||participants|||Number
2824262|NCT00352001|Primary|PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)|"For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement.~Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones.~Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality.~Hematologic Improvement (HI) is defined as: red blood cell increase of >=1.5g/dL, a platelet response of >=30X10^9/L or by at least 100% for values starting <20X10^9/L, or a neutrophil response of at least 100% and absolute increase of >0.5X10^9/L"|After 4 courses (4 months)|Intention to Treat|||participants|||Number
2824266|NCT00351936|Primary|Change From Baseline in Low-density Lipoprotein (LDL)|Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||mg/dL||Standard Deviation|Mean
2824268|NCT00351936|Primary|Change From Baseline in Waist-hip Ratio (WHR)|Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||cm||Standard Deviation|Mean
2824269|NCT00351936|Primary|Change From Baseline in Body Mass Index (BMI)|Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||kg/m^2||Standard Deviation|Mean
2824270|NCT00351936|Primary|Change From Baseline in Weight (Lbs)|Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4||||lbs||Standard Deviation|Mean
2824271|NCT00351819|Other Pre-specified|Insomnia Severity Index (ISI) at Week 14|ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
2824272|NCT00351819|Other Pre-specified|C-reactive Protein (CRP) at Week 14|High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6%|Week 14 after intervention|All available data expressed as absolute values at week 14.|||mg/L||Standard Deviation|Mean
2824273|NCT00351819|Other Pre-specified|Leptin at Week 14|Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA).|Week 14 after intervention|All available data expressed as absolute values at week 14.|||ug/L||Standard Deviation|Mean
2824274|NCT00351819|Other Pre-specified|Adiponectin at Week 14|Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore).|Week 14 after intervention|All available data expressed as absolute values at week 14.|||ug/mL||Standard Deviation|Mean
2824275|NCT00351819|Other Pre-specified|HOMA IR Score at Week 14|Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose * insulin / 22.5.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||HOMA IR score||Standard Deviation|Mean
2824276|NCT00351819|Other Pre-specified|Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14|All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading.|Values at week 14 after intervention|All available data expressed as absolute values at week 14.|||pmol/L||Standard Deviation|Mean
2824277|NCT00351819|Other Pre-specified|Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14|All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||mmol/L||Standard Deviation|Mean
2824278|NCT00351819|Other Pre-specified|HbA1c at Week 14||Week 14 after intervention|All available data expressed as absolute values at week 14.|||percentage of glycosylated hemogobin||Standard Deviation|Mean
2824279|NCT00351819|Other Pre-specified|Lipid Profile at Week 14|Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||mmol/L||Standard Deviation|Mean
2824280|NCT00351819|Other Pre-specified|Body Composition at Week 14|Body composition was measured using dual-energy X-ray absorptiometry scan.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||kg||Standard Deviation|Mean
2824281|NCT00351819|Other Pre-specified|Inflammatory Cytokines at Week 14|The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha).|Week 14 after intervention|All available data expressed as absolute values at week 14.|||pg/mL||Standard Deviation|Mean
2824282|NCT00351819|Other Pre-specified|Luteinizing Hormone Values at Week 14|Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||U/L||Standard Deviation|Mean
2824283|NCT00351819|Other Pre-specified|Sex Hormone Binding Globulin (SHBG) at Week 14|Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||nmol/L||Standard Deviation|Mean
2824284|NCT00351819|Other Pre-specified|Free Testosterone Values at Week 14|Free testosterone was calculated using a law of mass action equation.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||pg/mL||Standard Deviation|Mean
2824285|NCT00351819|Other Pre-specified|Total Testosterone Values at Week 14|Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||ng/dL||Standard Deviation|Mean
2824286|NCT00351819|Secondary|Pain Catastrophizing Scale (PCS) at Week 14|PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences.|Values at week 14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
2824287|NCT00351819|Secondary|Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14|The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.|Week 14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
2824288|NCT00351819|Secondary|Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.|Week14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
2824289|NCT00351819|Primary|Ice Water-induced Cold Pain and Its After-sensation at Week 14|Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.|Week 14 after intervention||||seconds||Standard Deviation|Mean
2824290|NCT00351819|Primary|Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14|Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain.|Week 14 after intervention||||watts||Standard Deviation|Mean
2824291|NCT00351819|Primary|Algometer-induced Pressure Pain at Week 14|A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.|Week 14 after intervention||||kPa/cm2||Standard Deviation|Mean
2824292|NCT00351819|Primary|Brief Pain Inventory (BPI) at Week 14|BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).|Week14 after intervention|All available data expressed as absolute values at week 14.|||units on a scale||Standard Deviation|Mean
2824293|NCT00351741|Secondary|Ventilator Associated Tracheobronchitis (VATB)|Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission|checked daily||||Participants|||Number
2824294|NCT00351741|Secondary|Barotrauma|Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele >2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis.|28 days||||Participants|||Number
2824295|NCT00351741|Secondary|Need for Rescue Ventilator|Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation.|28 days||||Participants|||Number
2824296|NCT00351741|Secondary|Ventilator Associated Pneumonia|Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.|28 days||||Participants|||Number
2824297|NCT00351741|Secondary|Death|In-hospital death.|during hospitalization||||Participants|||Number
2824298|NCT00351741|Secondary|Days Free From Nonpulmonary Organ Failure|days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.|28||||Days||Standard Deviation|Mean
2824299|NCT00351741|Primary|Ventilator-free Days During the First 28 Days|The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.|28 days||||Days||Standard Deviation|Mean
2824300|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824301|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824302|NCT00351533|Secondary|Change in Plasma Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824303|NCT00351533|Secondary|Change in Plasma Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824304|NCT00351533|Secondary|Change in Plasma Interleukin-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824305|NCT00351533|Secondary|Change in BALF Neutrophil Count|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||# of cells/mm^3||Inter-Quartile Range|Median
2824306|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2825195|NCT00342563|Primary|Percent Heavy Drinking Days During Active Treatment Phase|Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) average during 90 days of treatment.|12 weeks||||days||Standard Error|Mean
2824307|NCT00351533|Secondary|Change in BALF Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824308|NCT00351533|Secondary|Change in BALF Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824309|NCT00351533|Secondary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9||||pg/mL||Inter-Quartile Range|Median
2824310|NCT00351533|Secondary|60-day Mortality||60 days from day of enrollment into study||||Participants|||Number
2824311|NCT00351533|Secondary|Hospital Mortality||At end of hospitalization||||Participants|||Number
2824312|NCT00351533|Secondary|Hospital Length of Stay||At end of hospital admission||||Days||Standard Deviation|Mean
2824313|NCT00351533|Secondary|ICU-free Days During First 28 Days After Study Enrollment|ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.|28 days||||Days||Standard Deviation|Mean
2824314|NCT00351533|Secondary|Ventilator-free Days During First 28 Days After Study Enrollment|Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.|28 days||||Days||Standard Deviation|Mean
2824315|NCT00351533|Secondary|Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment|"Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.~Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs."|Throughout hospital stay||||Scores on a scale||Standard Deviation|Mean
2824316|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824317|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824318|NCT00351533|Secondary|Change in Plasma Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824319|NCT00351533|Secondary|Change in Plasma Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824320|NCT00351533|Secondary|Change in Plasma Interleukin-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824321|NCT00351533|Secondary|Oxygenation|PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5||||PaO2/FiO2||Standard Deviation|Mean
2824322|NCT00351533|Secondary|Static Lung Compliance|30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5||||L/cm H20||Standard Deviation|Mean
2824323|NCT00351533|Secondary|Change in BALF Neutrophil Count|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||# of cells/mm^3||Inter-Quartile Range|Median
2824324|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824325|NCT00351533|Secondary|Change in BALF Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824326|NCT00351533|Secondary|Change in BALF Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5||||pg/mL||Inter-Quartile Range|Median
2824403|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||micromoles per liter (µmol/l)||Standard Deviation|Mean
2824327|NCT00351533|Primary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|The primary outcome was >=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).|||pg/mL||Inter-Quartile Range|Median
2824328|NCT00351468|Secondary|Best Post-Baseline Change in the FACT-TH6 at Any Time Point Compared to Baseline|The FACT-TH6 consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Although the six items do not constitute a formal domain or subscale of the FACT‑Th assessment tool, these items had been identified by focus groups of patients with chronic ITP as important indicators of their HRQoL. Items were reverse-scored as necessary such that higher scores represent higher HRQoL. Total scores ranged from 0 to 24. Recall period is not specified. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years||||Points on a scale||95% Confidence Interval|Mean
2824329|NCT00351468|Secondary|Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline|"The FACIT-Fatigue consists of 13 questions in which patients rate the frequency (0-4) of symptoms of fatigue, in terms of tiredness, weakness, and fatigue Items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 52.Using anchor-based estimates, the minimally important difference in this subscale is 3.0 points.~Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group"|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years|ITT|||Points on a scale||95% Confidence Interval|Mean
2824330|NCT00351468|Secondary|Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline|The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy, and social motivation, either as symptoms of chronic ITP or as a side effect of pharmacotherapy. Minimal clinically important differences are estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 108 points. Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years||||Points on a scale||95% Confidence Interval|Mean
2824331|NCT00351468|Secondary|Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline|The SF-36v2 assessment tool was used to obtain information about subjects' general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group|Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years||||Points on a scale||95% Confidence Interval|Mean
2824332|NCT00351468|Secondary|Maximum ITP Bleeding Score at Any Time During the Study During All Stages.|The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding|Baseline up to 2 years||||Participants|||Number
2824333|NCT00351468|Secondary|Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.|Rescue treatment is defined as a composite of: new ITP medication, increased dose of a concomitant ITP medication, platelet transfusion, and splenectomy. Subjects may have received more than 1 type of rescue therapy|Baseline up to 2 years||||Participants|||Number
2824334|NCT00351468|Secondary|Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.|Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.|Baseline up to 2 years||||Participants|||Number
2824335|NCT00351468|Secondary|Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL|Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.|Baseline up to 2 years|ITT|||Participants|||Number
2824336|NCT00351468|Secondary|Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication|"If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses.~Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses."|Baseline up to Year 7/Week 364|ITT population|||Participants|||Number
2824337|NCT00351468|Secondary|Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication|"Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses.~Platelet counts within 7 days after a platelet transfusion are not classed as responses.~Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses."|Baseline up to 2 years|ITT population|||Participants|||Number
2824338|NCT00351468|Primary|Overall Summary of On-Therapy Adverse Events (Safety Population)|All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.|Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364||||Participants|||Number
2824339|NCT00351416|Primary|FSH Level|Difference in FSH peak following letrozole administration compared with control cycle|EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mm||||IU/L||Standard Error|Mean
2824340|NCT00351377|Secondary|Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient|"Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.|||Participants|||Number
2824341|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Patient|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant's GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.|||Participants|||Number
2824342|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Physician|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant's GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the physician."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.|||Participants|||Number
2824343|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
2824344|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium|The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
2824345|NCT00351377|Secondary|Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
2824346|NCT00351377|Secondary|Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium|Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
2824347|NCT00351377|Secondary|Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium|Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
2824493|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824348|NCT00351377|Primary|Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)|Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.|Baseline and 6 - 8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.|||Scores on a scale||Standard Deviation|Mean
2824349|NCT00351351|Primary|Kidney Stone Clearance Rate|stone clearance rate calculated in mm^2/min per protocol specification|6 months|Sample size calculations were performed using a two-sided Student’s t-test with a power of 90% and a significance level of α = 0.05|||mm^2/min||Full Range|Mean
2824350|NCT00351299|Secondary|In-hospital Mortality|Did patient die while in the hospital? (Yes/No)|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end||||Participants|||Count of Participants
2824351|NCT00351299|Secondary|Ease of Management for the Nursing Staff|"Subjective measure rating 3 categories for ease of management:~Mostly easy~Easy to manage 75% of the time~Not easy to manage"|Up to initial 48 hours||||Participants|||Count of Participants
2824352|NCT00351299|Secondary|Length of Intensive Care Unit (ICU) Stay|Number of days intensive care unit (ICU) stay|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end||||days||Inter-Quartile Range|Median
2824353|NCT00351299|Secondary|Length of Ventilator Support|Number of days on mechanical ventilation|Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end||||days||Inter-Quartile Range|Median
2824354|NCT00351299|Primary|Resolution of Delirium|"Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments.~The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking."|Up to 7 days||||Participants|||Count of Participants
2824355|NCT00351273|Secondary|78 Tender Joint Count (TJC)|Comparison of modified 78 Tender Joint Count (TJC) between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of tender joing in each of the 78 joints was determined by examination. Each tender joint receives a value of 1, ranging from 0-78 as a possible score.|Baseline, Month 1, 3, 6 and 9||||Tender Joints||Full Range|Mean
2824356|NCT00351273|Secondary|Swollen 76 Joint Count (SJC)|Comparison of modified Swollen Joint Counts between combination antibiotic and placebo groups at Baseline, Month 1, 3, 6 and 9. Determination of swelling in each of the 76 joints was determined by any swelling or absence of swelling. Each swollen joint receives a value of 1, ranging from 0-76 as a possible score.|Baseline, month 1,3,6 and 9||||Swollen Joints||Full Range|Mean
2824357|NCT00351273|Secondary|PhGA Assessment|Comparison of Physician's global assessment of disease activity (PhGA) using 0-100mm visual analog scale (VAS) , where 0 indicates the best possible outcome and 100 indicates the worst possible outcome, in combination antibiotic vs placebo groups at Baseline, month 1,3,6 and 9|Baseline, month 1,3,6 and 9||||units on a scale||Full Range|Mean
2824358|NCT00351273|Secondary|HAQ DI Score|"Comparison of HAQ-DI score of combination antibiotic group vs placebo group at Baseline, Month 1,3,6 and 9 The Health assessment questionnaire disability index (HAQ-DI) is a questionnaire for the assessment of Rheumatoid Arthritis. The questionnaire is a patient reported outcome (PRO) which is usually self-administered by the patient There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. If the section score is already 2 or more then no modification is made.~The 8 scores of the 8 sections are summed and divided"|Baseline, Month 1,3,6 and 9||||score on a scale||Full Range|Mean
2824359|NCT00351273|Secondary|hsCRP|Comparison of high sensitivity C-reactive protein measurement in combination antibiotic group vs placebo group at Baseline, Month 1, 3, and 6|Baseline, Month 1, 3, and 6||||mg/litre||Full Range|Mean
2824360|NCT00351273|Secondary|Erythrocyte Sedimentation Rate (ESR)|Comparison of mean ESR rates of combination antibiotic group vs placebo group at Baseline, Month 1, 3, 6 and 9|Baseline Month 1, 3, 6 and 9||||millimeters/hour||Full Range|Mean
2824361|NCT00351273|Secondary|Number of Patients With a Complete Response (Resolution of All Symptoms)|Patients who completed full 6 months of treatment that reported feeling complete resolution of symptoms at month 6 visit and had no worsening of condition at the month 9 follow up visit.|Months 6 and 9|Patients randomized to combination antibiotics who believed that their disease went into complete remission during the trial|||Participants|||Count of Participants
2824362|NCT00351273|Primary|Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.|The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo.|Month 6|Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders.|||participants|||Number
2824363|NCT00351039|Secondary|Overall Survival (Median Survival [MS])|Secondary Objective: Determine the Overall Survival (median survival[MS]) in patients with advanced NSCLC treated with this regimen. Patients were to be followed until death and survival curves were to be generated.|26 Months|Had the study been completed as planned we would have measured Overall Survival described as Median Survival. This study was closed early due to poor accrual.||||||
2824364|NCT00351039|Primary|Progression Free Survival (PFS)|The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.|26 months|No patients proceeded to Phase II for evaluation.||||||
2824365|NCT00351039|Secondary|Number of Participants With Grade 3 and Grade 4 Adverse Events|By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines.|26 Months|This study was initially intended to be a Phase I/II study with a brief Phase I Run-in. After the brief Phase I Run-in the study was closed without initiating the Phase II component.|||Participants|||Number
2824366|NCT00351039|Secondary|Quality of Life (QOL)|"The Scales we were intending to use were:~Instrumental Activities of Daily Living (IADL): Range of Scale 0 (Best) to 8 (Worst).~Cumulative Illness Rating Scale-Geriatric (CIRS-G): Range of Scores 1(Best) to 18 (Worst).~Functional Assessment of Cancer Therapy-Lung (FACT-L): Range of Scores 0 (Best) to 48 (Worst).~Fatigue Symptom Inventory (FSI): Range of Scores 0(Best) to 121 (Worst).~Each scale would have been evaluated independently. Since the study was not completed and closed early due to poor accrual, none of the QOL parameters were analyzed."|26 Months|Since no patients were accrued to the Phase II component of the trial, 0 patients were analyzed for these scales.||||||
2824367|NCT00351039|Secondary|Number of Patients Who Responded to Treatment|"Phase I:~Response Evaluation Criteria In Solid Tumors (RECIST)Criteria was used for Response. Partial Response (PR) is defined as at least a 30% decrease in the sum of Longest Dimention (LD) of target lesions taking as reference the baseline sum LD."|26 Months|8 patients were accrued to the Phase I component of the trial. No patients were accrued to the Phase II component of the trial.||||||
2824368|NCT00351039|Secondary|One-year Survival(1-year S)|Secondary Objective: One-year survival(1-year S) in patients with advanced NSCLC treated with this regimen.|26 Months|Had the study been completed as planned we would have measured the One-year Survival. This study was closed early due to poor accrual.||||||
2824369|NCT00351000|Primary|Change From Baseline on Fasting Insulin|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6||||microIU/L||Standard Deviation|Mean
2824370|NCT00351000|Primary|Change From Baseline in Fasting Glucose|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6||||mg/dL||Standard Deviation|Mean
2824371|NCT00350870|Primary|Change in Cocaine Use by Urine Toxicology Results|We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.|12 weeks||||percentage of negative urines||Standard Deviation|Mean
2824372|NCT00350870|Primary|Change in Cocaine Use by Self Report|Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.|12 weeks||||percentage of days abstinent||Standard Deviation|Mean
2824373|NCT00350844|Secondary|Compliance|Secondary outcome measures included compliance; laboratory measures of therapy-related toxicity; laboratory biomarkers for hemolysis, oxidative stress and endothelial injury; and quality of life measures by Child Health Questionnaire (CHQ).|Throughout study|||||||
2824374|NCT00350844|Primary|Tricuspid Regurgitant Jet Velocity|Primary outcome measure was tricuspid regurgitant jet velocity (TRJV) by echocardiogram after 6 and 12 months of hydroxyurea therapy.|6 and 12 months after HU therapy begins|Study was terminated and 0 participants were analyzed.||||||
2824375|NCT00350792|Secondary|Estimated Probability of One Year Progression-free Survival|Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.|baseline to measured progressive disease or death, 1 year|Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.|||percentage of patients||95% Confidence Interval|Median
2824376|NCT00350792|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 14.5 months)|Twenty patients were censored as they were still alive at the time of the data cut-off.|||months||95% Confidence Interval|Median
2824377|NCT00350792|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.|||weeks||95% Confidence Interval|Median
2824378|NCT00350792|Other Pre-specified|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.|||weeks||Standard Error|Mean
2824379|NCT00350792|Primary|Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)|Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured objective tumor response (up to six 21-day cycles)|Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).|||percentage of participants|||Number
2824494|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824380|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
2824381|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
2824382|NCT00350779|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.|||Percent||95% Confidence Interval|Least Squares Mean
2824383|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and Week 18|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.|||mg/dL||95% Confidence Interval|Least Squares Mean
2824384|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.|||mg/dL||95% Confidence Interval|Least Squares Mean
2824385|NCT00350779|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.|||Percent||95% Confidence Interval|Least Squares Mean
2824386|NCT00350727|Primary|Progression-free Survival at 6 Months|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. The participants who are still alive and whose follow-up extends to at least 6 months are considered At Risk.|Date of the first dose of study drug to 6 months|All-treated Population for Phase II|||participants|||Number
2824387|NCT00350727|Primary|Overall Response (OR) in Phase II Based on an Independent Radiologist's Review|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment|||participants|||Number
2824388|NCT00350727|Secondary|Time to Disease Progression or Death Due to Any Cause||Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II|||days||95% Confidence Interval|Median
2824389|NCT00350727|Secondary|Progression-free Survival|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used.|Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II|||participants|||Number
2824390|NCT00350727|Primary|Overall Response (OR) in Phase II Based on the Investigator-assigned Response|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment.|||participants|||Number
2824404|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||Units per liter (U/L)||Standard Deviation|Mean
2824391|NCT00350727|Primary|Overall Response (OR) in Phase II Based GlaxoSmithKline's Evaluation|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population in Phase II who also had a response assessment|||participants|||Number
2824392|NCT00350727|Primary|Number of Participants Experiencing a Dose-limiting Toxicity at the Indicated Dose|A dose-limiting toxicity (DLT) is defined as predefined adverse events or events that prevented participants from receiving 75% of their scheduled doses or from starting their next treatment period. The dose at which no more than 1 out of 6 participants experiences a DLT is defined as the optimally tolerated regimen. The OTR is important because it determines the highest dose combination that can be given without significant toxicity.|Cycle 1 in Phase I (up to Day 28)|All-treated Population for Phase I|||participants|||Number
2824393|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||seconds (sec)||Standard Deviation|Mean
2824394|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phases I and II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||ratio||Standard Deviation|Mean
2824395|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
2824396|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||percent||Standard Deviation|Mean
2824397|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||grams per Liter (g/L)||Standard Deviation|Mean
2824398|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.|||nanomoles per liter (nmol/l)||Standard Deviation|Mean
2824399|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||milliunits per liter (mU/L)||Standard Deviation|Mean
2824400|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.|||picomoles per liter (pmol/l)||Standard Deviation|Mean
2824401|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroxine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||picomoles per liter (pmol/l)||Standard Deviation|Mean
2824402|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||millimoles per liter (mmol/l)||Standard Deviation|Mean
2824440|NCT00350519|Secondary|Number of pRBC Units Transfused During Study||Baseline (Day -10) to end of study (Day 32)|ITT, No formal analysis was conducted due to early termination and small sample size|||units||Standard Deviation|Mean
2824405|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||International Units per Liter (IU/L)||Standard Deviation|Mean
2824406|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||grams per liter (g/L)||Standard Deviation|Mean
2824407|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||seconds (sec)||Standard Deviation|Mean
2824408|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||ratio||Standard Deviation|Mean
2824409|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
2824410|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||percent||Standard Deviation|Mean
2824411|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.|||grams per liter (g/L)||Standard Deviation|Mean
2824412|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||nanomoles per liter (nmol/l)||Standard Deviation|Mean
2824413|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||milliunits per liter (mU/L)||Standard Deviation|Mean
2824414|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroxine and Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||picomoles per liter (pmol/l)||Standard Deviation|Mean
2824415|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||millimoles per liter (mmol/l)||Standard Deviation|Mean
2824416|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||micromoles per liter (µmol/l)||Standard Deviation|Mean
2824417|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||Units per liter (U/L)||Standard Deviation|Mean
2824441|NCT00350519|Secondary|Hemoglobin Change From Baseline to End of Study|End of Study Hemoglobin minus baseline Hemoglobin|Baseline (Day-10) to end of study (Day 32)|All Subjects, No formal analysis was conducted due to early termination and small sample size|||g/dL||Standard Deviation|Mean
2824418|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||International Units per Liter (IU/L)||Standard Deviation|Mean
2824419|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.|||grams per liter (g/L)||Standard Deviation|Mean
2824420|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. bpm, beats per minute.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.|||participants|||Number
2824421|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Diastolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.|||participants|||Number
2824422|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Systolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population (all participants who were given any dose of study medication) for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.|||participants|||Number
2824423|NCT00350727|Secondary|Phase II: Plasma Concentrations of the Circulating Biomarkers VEGF, sVEGFR-1, and sVEGFR-2.||Completed during first cycle of treatment.|||||||
2824424|NCT00350727|Secondary|Phase II: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, Tmax, and C24 of Pazopanib and Lapatinib, as Appropriate, When Administered Together in Combination With Non-EIAC.||Completed during first cycle of treatment.|||||||
2824425|NCT00350727|Secondary|Phase I: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, the Time to Maximum Observed Concentration (Tmax) and C24 of Pazopanib and Lapatinib When Administered in Combination With EIAC.||Completed during first cycle of treatment.|||||||
2824426|NCT00350636|Secondary|Change From Baseline in Average Urine Void Volume|Change from baseline to Week 12 in average urine void volume|Change from Baseline to Week 12||||mL||Standard Deviation|Mean
2824427|NCT00350636|Secondary|Baseline Average Urine Void Volume|Baseline average urine void volume|Baseline||||mL||Standard Deviation|Mean
2824428|NCT00350636|Primary|Change From Baseline in Average Daily Number of Incontinence Episodes|Change from Baseline to Week 12 in average daily number of incontinence episodes|Baseline to Week 12||||Number of episodes||Standard Deviation|Mean
2824429|NCT00350636|Secondary|Change From Baseline in Average Daily Urinary Frequency|Change from baseline in average daily urinary frequency|Baseline to 12 weeks||||Number of urinary episodes||Standard Deviation|Mean
2824430|NCT00350636|Secondary|Baseline Average Daily Urinary Frequency|Number of daily urinary voids|Baseline||||Number of urinary episodes||Standard Deviation|Mean
2824431|NCT00350636|Primary|Baseline Average Number of Daily Incontinence Episodes|Average number of daily incontinence episodes at baseline|Baseline||||Number of episodes||Standard Deviation|Mean
2824432|NCT00350623|Primary|Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks||30 weeks|No data analysis was performed.||||||
2824433|NCT00350545|Secondary|Overall Survival|Overall survival at 6 and 12 months|6 and 12 months||||Participants|||Count of Participants
2824434|NCT00350545|Secondary|Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation|Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment.|6 and 12 Months|At initiation of therapy, all patients were on high dose of steroids (1mg/kg/day). Failure-free survival (FFS) rate for the 31 patients at 6 and 12 months post-rituximab initiation.|||Participants|||Count of Participants
2824435|NCT00350545|Secondary|Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial|Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began|1 year||||Participants|||Count of Participants
2824436|NCT00350545|Secondary|Number of Participants With Complete and/or Partial GVHD Response|To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began|6 months||||Participants|||Count of Participants
2824437|NCT00350545|Primary|Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.|Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse.|6 months|Participants who have complete or partial clinical response to therapy as well as a steroid dose, tapered to <0.25 mg/kg/day within 6 months after initiation of rituximab|||Participants|||Count of Participants
2824438|NCT00350532|Primary|Acetylcholine Concentration in Cerebrospinal Fluid|Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).|60 minutes|There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain|||picograms per milliliter (pg/ml)||Full Range|Mean
2824439|NCT00350519|Secondary|Hospital Length of Stay||Surgery to hospital discharge|ITT, No formal analysis was conducted due to early termination and small sample size|||days||Standard Deviation|Mean
2824443|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [On Dopamine Medication]|Outcome is entropy change from baseline to immediate completion of 4 week intervention when participants remained on their normal dosage of dopamine medication. Entropy is quantitative index of facial movement that is computed from changes in pixel intensity as the face moves. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity. Greater expressivity is desired outcome.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Based on individuals who completed baseline and post-treatment assessment following 4 weeks of intervention. One individual from each treatment group dropped out during the first week of intervention and were not included in analyses.|||Units on a scale||Standard Deviation|Mean
2824444|NCT00350402|Other Pre-specified|Change From Baseline in Maximal Inspiratory Pressure (MIP)|The dependent variable is the change in maximal inspiratory pressure (MIP) from baseline to immediate completion of 4-week intervention. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible. This was measured over 5-7 trials by placement of lips around a mouthpiece attached to a calibrated fluke digital pressure gauge. From these trials, an average maximum inspiratory pressure (MIP) was computed. This was done at baseline and post-treatment. Greater MIP changes correspond to greater treatment-related effects of exercise.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Included participants who underwent baseline, intervention, and post-treatment assessment. Two individuals dropped out during the first week of intervention, one from each intervention group. Additionally, there was faulty data, due to equipment failure for one individual in the sham group, thereby reducing N in this group to 19.|||units of pressure (cmH20)||Standard Deviation|Mean
2824445|NCT00350402|Secondary|Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)|The PDQ-39 is a widely used quality of life measure that is specific to Parkinson disease. Total raw score on the PDQ-39 ranges from 0 to 156. Higher scores reflect worse quality of life rating. Total score on PDQ-39 was used to compute pre-post treatment changes.|Baseline and 4 weeks (i.e., immediate post-intervention)|Participants who completed baseline,intervention, and post-intervention testing. Two individuals, one from each group, dropped out of the study during the first week of intervention.|||units on a scale||Standard Deviation|Mean
2824446|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [Off Dopamine Medication]|"Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition (off dopamine), entropy scores were obtained when participants were tested off their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period."|Baseline and 4 weeks (i.e., immediate after 4-week treatment)|All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.|||units on a scale||Standard Deviation|Mean
2824447|NCT00350363|Primary|Number of Participant With Positive Culture||2 weeks||||participants|||Number
2824448|NCT00350337|Secondary|Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose.|"For vireimia:~Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is >= LOD"|throughout study||||participants|||Number
2824449|NCT00350337|Secondary|Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued)|"Sero-response defined as:~For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer"|throughout study||||percentage of responders||95% Confidence Interval|Number
2824450|NCT00350337|Secondary|Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose|"Sero-response defined as:~For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer"|throughout study||||percentage of responders||95% Confidence Interval|Number
2824451|NCT00350337|Secondary|Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort)|"The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with suspected dengue occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered confirmed dengue. The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination."|Days 0-30 post vaccination periods (total vaccinated cohort)||||% of participants||95% Confidence Interval|Number
2824452|NCT00350337|Secondary|Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose|"Abnormal findings at DEN physical examination were defined as:~rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion."|throughout the 202 day study||||participants|||Number
2824453|NCT00350337|Secondary|Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period;|MA type = H0|up to 202 days||||participants|||Number
2824454|NCT00350337|Secondary|Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose|Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort)|within 31 days of study vaccine||||Number of AEs|||Number
2824455|NCT00350337|Secondary|Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine;||within 21 days after vaccination||||participants|||Number
2824476|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5|Diastolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
2824456|NCT00350337|Primary|Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine|Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded.|21 days following 1st vaccination dose||||participants|||Number
2824457|NCT00350337|Primary|Percentage of Subjects With Seropositivity Rates for Dengue Serotypes 1, 2, 3 and 4|Serpositivity rates for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1|Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3||||% participants with seropositivity rates||95% Confidence Interval|Number
2824458|NCT00350337|Primary|N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4|GMTs for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1|Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3|Number of subjects with titer within specified range|||GMT value||95% Confidence Interval|Mean
2824459|NCT00350272|Primary|The Safety Profile of Elvucitabine.|Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events and the frequency of Grade 3 and Grade 4 laboratory abnormalities.|12 Weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug.|||participants|||Number
2824460|NCT00350272|Primary|The Proportion of Subjects With Virologic Response for 10 mg/Day Elvucitabine in HIV-1-infected Subjects by 12 Weeks Compared With the Proportion of Subjects With Lamivudine 300 mg/Day.|Proportion of subjects having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected subjects over 12 weeks compared with the proportion of subjects having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.|12 Weeks|This primary outcome measure used the intent-to-treat population, defined as all randomized subjects who took at least 1 dose of study drug and had both a baseline HIV-1 RNA result and at least 1 HIV-1 RNA result after baseline assessment. For this analysis, all subjects who discontinued from the study before Week 12 were considered as NC=F.|||percentage of participants|||Number
2824461|NCT00350220|Primary|Peak Arterial Lactate Level|Peak arterial lactate level for the 48 hour post-op study period.|48 hours||||mmol/l||Standard Deviation|Mean
2824462|NCT00350220|Secondary|Mortality Before Hospital Discharge||30 days|||||||
2824463|NCT00350220|Secondary|Volume of Blood Transfused||3 days|||||||
2824464|NCT00350220|Secondary|Length of Vasoactive Agent Administration||3 days|||||||
2824465|NCT00350220|Secondary|Length of Oxygen Use||3 days|||||||
2824466|NCT00350220|Secondary|Length of Mechanical Ventilation||3 days|||||||
2824467|NCT00350220|Secondary|Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.||3 days|||||||
2824468|NCT00350220|Primary|Mean Arterial Lactate Level|Mean arterial lactate for the first 48 hours post-op.|48 hours||||mmol/L||Standard Deviation|Mean
2824469|NCT00350207|Secondary|Mean PEF Variability at Week 16|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 16 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
2824470|NCT00350207|Secondary|Mean PEF Variability at Week 12|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 12 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
2824471|NCT00350207|Secondary|Mean PEF Variability at Week 8|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 8 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
2824472|NCT00350207|Secondary|Mean PEF Variability at Week 4|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 4 weeks of treatment|FAS|||ratio expressed in percent||Standard Error|Least Squares Mean
2824473|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 5|Pulse rate collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||bpm||Standard Deviation|Mean
2824474|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 4|Pulse rate collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||bpm||Standard Deviation|Mean
2824475|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 3|Pulse rate collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||bpm||Standard Deviation|Mean
2824477|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4|Diastolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
2824478|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3|Diastolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
2824479|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 5|Systolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
2824480|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 4|Systolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
2824481|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 3|Systolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits|||mmHg||Standard Deviation|Mean
2824482|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 5|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824483|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 4|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824484|NCT00350207|Secondary|Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 6 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824485|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5|Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824486|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4|Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824487|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3|Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824488|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824489|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824490|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824491|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824492|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824495|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824496|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824497|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824498|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824499|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824500|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824501|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824502|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824503|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824504|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824505|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824506|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824507|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824508|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824509|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824510|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824511|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 16 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824512|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 12 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824513|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 8 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824514|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 4 weeks of treatment|FAS|||Unit on a scale||Standard Error|Least Squares Mean
2824515|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16|Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824516|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12|Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824517|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8|Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824518|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4|Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824519|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16|Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824520|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12|Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824521|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8|Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824522|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4|Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS|||L||Standard Error|Least Squares Mean
2824523|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 16|Mean weekly evening peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824524|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 12|Mean weekly evening peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824525|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 8|Mean weekly evening peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824526|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 4|Mean weekly evening peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824527|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 16|Mean weekly morning peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824528|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 12|Mean weekly morning peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824529|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 8|Mean weekly morning peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824530|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 4|Mean weekly morning peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS|||L/min||Standard Error|Least Squares Mean
2824531|NCT00350207|Primary|Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial|Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit|baseline and after 16 weeks of treatment|The Full analysis set (FAS) included patients who received at least one dose of randomised study medication and who had at least four patient diary records for at least one efficacy endpoint in any week after the first administration of the randomised treatment and baseline data for the corresponding efficacy endpoint.|||L/min||Standard Error|Least Squares Mean
2824532|NCT00350142|Secondary|Median Overall Survival Time|The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.|up to 3 years||||months||Full Range|Median
2824533|NCT00350142|Primary|Rate of Local Control|"The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.~Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression."|up to 3 years||||participants|||Number
2824534|NCT00350025|Secondary|Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging||Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)|Overall Survival|||weeks||95% Confidence Interval|Median
2824535|NCT00350025|Primary|Progression Free Survival||Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.||||weeks||95% Confidence Interval|Median
2824536|NCT00349973|Primary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Baseline and Follow-Up|Participants completing cognitive testing.|||units on a scale||Standard Deviation|Mean
2825009|NCT00345033|Primary|Change in Body Mass Index (BMI)|A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).|||kg/m^2||Standard Deviation|Mean
2824537|NCT00349973|Primary|Change in Negative Symptoms by Treatment Assignment|The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Mean SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline and Follow-Up|Participants completing SANS assessment.|||units on a scale||Standard Deviation|Mean
2824538|NCT00349973|Primary|Change in Positive Symptoms by Treatment Assignment|"The Brief Psychiatric Rating Scale (BPRS) consists of 20 items, with 6 of these items used to assess positive symptom change. The BPRS positive symptom items are: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, and unusual thought content. Each scale ranges from 1=Not Present to 7=Very Severe. A higher score indicates a more severe positive symptom rating."|Baseline and follow-up|Participants completing the BPRS assessment.|||units on a scale||Standard Deviation|Mean
2824539|NCT00349921|Primary|Number Meeting Success Criterion|Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection|baseline and 2 hours|The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain.|||participants meeting success criterion|||Number
2824540|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (Post Procedure)|Percent Stenosis assessed immediately post procedure from pre procedure|Post Procedure|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.|||Percentage Change from PreProcedure||Standard Deviation|Mean
2824541|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (6 mo Post Procedure)|Percent Stenosis assessed 6 mo Post Procedure from pre-procedure|6 mo|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.|||Percentage change from PreProcedure||Standard Deviation|Mean
2824542|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)|Successful stent/coil placement assessed at 6 mo post|6 mo||||Percentage of stable stent/coil placemen|||Number
2824543|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)|6 Months post|6 mo|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.|||percent occlusion||Full Range|Mean
2824544|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (Post Procedure)|Occlusion evaluated immediately post procedure|post procedure|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.|||percent occlusion||Full Range|Mean
2824545|NCT00349908|Secondary|The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.|An adverse event was defined as any untoward medical occurrence in a subject.|6 months|Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects.|||Number of adverse events|||Number
2824546|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)|Successful placement of the product assessed immediately post procedure|post procedure||||percentage of stable placement|||Number
2824547|NCT00349778|Secondary|Number of Participants That Relapse After Autologous Transplantation|Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation|5 years||||Participants|||Count of Participants
2824548|NCT00349778|Secondary|Overall Participant Survival (OS)|Survival status was assessed 5 years after transplant.|5 years||||Participants|||Count of Participants
2824549|NCT00349778|Primary|Number of Participants With Pulmonary Toxicity|Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis.|2 years||||Participants|||Count of Participants
2824550|NCT00349752|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab Pegol 400 mg) subjects randomized, 23 and 26 subjects respectively had available values at Baseline and Week 38 and are included in the summary based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2824551|NCT00349752|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 23 and 27 subjects respectively had available values at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2824552|NCT00349752|Secondary|Change From Baseline in CDAI Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively had available values at Baseline and at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2824553|NCT00349752|Secondary|Crohn's Disease Activity Index (CDAI) Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively are included in the summary of the Week 38, based on the intention-to-treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2824950|NCT00345579|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824554|NCT00349752|Secondary|Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.|6-week run-in period, 38-week double-blind treatment period|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 86 in each group had available values at the 6-week run-in period and over the 38-week double-blind treatment period.|||mg per week||Standard Deviation|Mean
2824555|NCT00349752|Secondary|Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period|The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.|Over the 48-week study period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.|||mg||Standard Deviation|Mean
2824556|NCT00349752|Secondary|Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.|Over the 38-week double-blind treatment period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.|||mg per week||Standard Deviation|Mean
2824557|NCT00349752|Secondary|Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|During the 38-week double-blind treatment period|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0|||days||Standard Deviation|Mean
2824558|NCT00349752|Secondary|Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|Week 38|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0|||percentage of subjects|||Number
2824559|NCT00349752|Secondary|Percentage of Subjects With Continuous Remission Off Steroids at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.|||percentage of subjects|||Number
2824560|NCT00349752|Primary|Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.|||percentage of subjects|||Number
2824561|NCT00349713|Secondary|Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time|Proportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90|90 Days||||number of participants with increase|||Number
2824562|NCT00349713|Secondary|Geometric Mean Antibody Titers Over Time|Measurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90|90 Days||||Geometric Mean of Antibody Titers||95% Confidence Interval|Geometric Mean
2824563|NCT00349713|Secondary|Anti-AMA1 Log Antibody Titers Over Time|Summary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90|90 Days||||log antibody titers||Standard Deviation|Mean
2824564|NCT00349713|Secondary|Antibody Response to FMP2.1 Over Time|Measurement of anti-AMA1 antibody titers over time|90 Days|Anti-AMA1 Antibody titers on days, 0, 14, 30, 44, 60, 74, and 90|||Antibody Titers||Standard Deviation|Mean
2824565|NCT00349713|Primary|Safety and Reactogenicity (SAEs and AEs)|The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.|12 months|Summary of Adverse Events by Group and Immunization Group|||Number of events|||Number
2825010|NCT00345033|Primary|Change in Weight|A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).|||kg||Standard Deviation|Mean
2824566|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.~HHD analysis was performed using Percent Change from Baseline. Each subject's baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||Percent change per 12 weeks||Standard Error|Mean
2824567|NCT00349622|Secondary|Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year|"The ALS-Specific Quality of Life Scale (ALSQOL). was developed, tested, and validated in subjects with ALS, and is not a health-related quality of life scale. The scale consists of 59 questions that ask about severity of the symptoms of ALS, mood and affect, intimacy, and social issues. Each question for the ALSQOL is scored from 0-10. With 59 questions, total score ranges from 0-590 with scores simply added, with 590 representing highest quality of life. However since 10 is maximally weighted towards negative values on some questions and positive values on others, the following questions must have results transposed (Simply reverse the scale, for instance 10=0 and 0=10) prior to analysis: 1-10, 11, 16, 19, 24, 26, 28, 32, 35, 36, 38, and 41. Optional items are 50, 53, 56, and 59. These questions are not included on any scale or in any quantitative analyses.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||units on a scale per 12 weeks||Standard Error|Mean
2824568|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.~HHD analysis was performed using Percent Change from Baseline. Each subject's baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||Percent change per 12 weeks||Standard Error|Mean
2824569|NCT00349622|Secondary|Change in % Vital Capacity From Screening to One Year|"Vital Capacity is measured as the percent predicted per subject based on age, gender, and height, and is performed as a Slow Vital Capacity.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year||||percent change in VC per 12 weeks||Standard Error|Mean
2824570|NCT00349622|Primary|Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year|"Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised (ALSFRS-R) is a quickly administered (five minute) ordinal rating scale used to determine patients' assessment of their capability and independence in 12 functional activities/questions. The 12 functional activities/questions are rated on a scale of 0 to 4 for a total scoring range of 0-48, with 48 representing optimal function. All 12 activities are relevant in ALS.~This outcome measure calculation is based on measurements every 8 weeks from the Baseline Visit up until one year."|Every 8 weeks for one year||||units on a scale per 8 weeks||Standard Error|Mean
2824571|NCT00349622|Primary|Survival|Survival is presented as median day of survival for each group. Survival is defined as time to death, tracheostomy or the initiation of permanent assisted ventilation (PAV).|From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)||||days||95% Confidence Interval|Median
2824572|NCT00349466|Secondary|Use of Artificial Tears|daily use of REFRESH TEARS® Lubricant Eye Drops artificial tears supplied to each patient was recorded in diaries provided to patients|12 weeks|||||||
2824573|NCT00349466|Secondary|Tear Meniscus (TM) Height|Indicator of tear volume. TM was recorded on a scale from 0-3, with 0=none, 1=trace, 2=normal, and 3=high.|12 weeks|||||||
2824574|NCT00349466|Secondary|Dry Eye Symptom Score|consists of 12 questions designed to assess the symptoms of ocular irritations, covering three areas: ocular symptoms, environmental triggers and vision-related function|12 weeks||2021-12-31|12/2021||||
2824575|NCT00349466|Secondary|Proportion of Clinical Success|improvement of ≥25% over baseline at Week 12 in tear breakup time (BUT), superficial punctate keratitis as assessed by fluorescein staining (FS), or ST|12 weeks||2021-12-31|12/2021||||
2824576|NCT00349466|Primary|Fluorescein Staining of the Cornea|Severity of corneal epithelial loss as graded by Fluorescein Staining of the cornea, assessed on a 0-4+ scale with 0 = none and 4+ = severe de-epithelialization, expressed as number of participants with >25% improvement at Week 12 relative to baseline|Baseline and 12 weeks|Per protocol, observed values|||Participants|||Number
2824577|NCT00349466|Primary|Tear Break-Up Time|time elapsed between a complete blink and the development of the first random dry spot on the tear film|12 weeks|||||||
2824578|NCT00349466|Primary|Schirmer Test (ST)|involved placing a standardized paper tear strip inside the lower eyelid for 5 minutes. The tear strip was then removed and the length of the strip that was wet from tears was measured in millimeters|12 weeks|||||||
2824579|NCT00349388|Secondary|Improved Medication Compliance.|Not applicable : unable to measure secondary outcome because no one was enrolled in once a day dose arm. Therefore, no comparisons can be made to see if once a day dosing would have higher compliance than taking medication BID or TID|overall study|Not applicable: unable to measure secondary outcome because no one was enrolled in once a day dose arm. Therefore, no comparisons can be made to see if once a day dosing would have a higher compliance than taking medication BID or TID. Study was terminated due to lack of enrollment.|||Participants|||Count of Participants
2824580|NCT00349388|Primary|Once Daily Dosing Works as Well a Multiple Dosing a Day.|subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported|overall study|cannot analysze primary outcome because no subjects were enrolled in the once a day dose arm. Study was terminated due to lack of enrollment||||||
2824581|NCT00349349|Secondary|Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2824582|NCT00349349|Secondary|Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
2824583|NCT00349349|Secondary|Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Half-life ( t1/2) is defined as the terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7) and Visit14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
2824584|NCT00349349|Secondary|AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. AUC(0-tau) is AUC from the start of infusion over the dosing interval.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.|||Milligrams x hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
2824585|NCT00349349|Secondary|Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the trough serum concentration (measured concentration at the end of a dosing interval [taken directly before the next administration]). No drug was present before the first infusion; therefore, there are no Ctrough results for Dose 1|Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
2824586|NCT00349349|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up)|FAS|||participants|||Number
2824587|NCT00349349|Secondary|Number of Participants With Complete Resolution of Splenomegaly|"Participants with complete resolution of enlarged spleen (splenomegaly) were defined as those with an enlarged palpable spleen at baseline followed by the absence of splenomegaly post-baseline (i.e., the spleen was of normal size). Spleen size was assessed by physical examination and documented as centimeters under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines)."|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with splenomegaly at baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline splenomegaly and a post-baseline assessment are included.|||participants|||Number
2824588|NCT00349349|Secondary|Number of Participants With Improvement in Neutropenia|Low levels of neutrophils (neutropenia) may increase the risk of developing serious infections and may be considered an adverse condition and evaluated on the NCI CTC with a grade. Improvement in neutropenia is defined as a decrease from Visit 2 (baseline) by at least one NCI CTC grade. Improvement is defined as a decrease from Visit 2 by at least one NCI CTC grade.|Baseline (Visit 2) to Week 28|FAS. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.|||participants|||Number
2824589|NCT00349349|Secondary|Number of Participants With Complete Resolution of Hepatomegaly|"Participants with complete resolution of enlarged liver (hepatomegaly) were defined as those with an enlarged palpable liver at baseline followed by the absence of hepatomegaly post- baseline (i.e., the liver was of normal size). Liver size was assessed by physical examination and documented as centimeters under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines)."|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with hepatomegaly from baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline hepatomegaly and a post-baseline assessment are included.|||participants|||Number
2824590|NCT00349349|Secondary|Number of Participants With Improvement in Thrombocytopenia (Thromb.)|Improvement in thromb. is defined as a decrease from Visit 2 by >=1 National Cancer Institute Common Terminology Criteria (NCI CTC) grade. Thromb. is defined as low platelet counts resulting from refractory CLL, damage from prior treatment, advanced age, or reduced bone marrow function and can be considered as an adverse condition. Adverse events (AEs) such as thromb. in a cancer indication are graded on a scale determined by the NCI called the NCI CTC: lowest, grade 1; highest, grade 5 (death). Changes in this grading can assess improvements or declines in the severity of the AE.|Baseline (Visit 2) to Week 28|FAS. Only those participants remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.|||participants|||Number
2825011|NCT00345033|Primary|Change in Total Cholesterol|A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N = 30).|||mg/dL||Standard Deviation|Mean
2824591|NCT00349349|Secondary|Number of Participants With Improvement in Hemoglobin|The number of participants (par.) who had improvement in hemoglobin levels >=11 grams (g)/deciliter (dl) (6.8 millimoles/liter) or 50% improvement over baseline was measured.|Baseline (Visit 2) to Week 28|FAS. Par. were excluded from analysis if they received treatment of red blood cells (RBCs), received transfusions or a RBC growth factor (erythropoietin), died, withdrew from the trial, or began next CLL treatment. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.|||participants|||Number
2824592|NCT00349349|Secondary|Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening|The number of participants (par.) who were positive, negative, or had missing data for the following prognostic factors indicative of altered responsiveness to treatment and/or survival was measured: 17p-, 11q-, +12q, 6q-, 13q-. Par. were assessed by FISH for these chromosomal abnormalities known tobe prognostic for time to treatment and survival when detected at diagnosis. Par. were categorized by the chromosomal abnormality detected: 17 p deletion, 11q deletion (but not 17 p deletion), 12 q trisomy (but not 17 p or 111q deletion), 13q deletion only, and no chromosomal abnormalities found.|Screening (Visit 1, <=14 days prior to Visit 2)|FAS. Par. were categorized hierarchically (by severity of abnormality): par. with a 17 p deletion (D); par. with an 11q D, but not a 17 p D; par. with 12q trisomy, but not a 17p or 11q D; par. with no aberrations found; par. with a 13q D as the sole aberration; and par. with 6q D (and not any of the above categories). Some par. had missing data.|||participants|||Number
2824593|NCT00349349|Secondary|Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24|ECOG performance status is a measure of the participant's ability to carry out activities of daily living on 6-point scale (0=fully active, 1=restricted in physically activity, ambulatory, 2=ambulatory [>50% of waking hours], 3=capable of only limited self care, 4=completely disabled, 5=Dead). Improvement in ECOG performance status is defined as a decrease from baseline by at least one score on the ECOG scale.|Baseline (Visit 2) and Week 24|FAS. Data were provided for participants (par.) with an ECOG score >0 at baseline attending each visit. Par. withdrawn from the study were not analyzed. (55 par. had an ECOG performance status of 0 at baseline and therefore did not have the opportunity to improve. No par. with an ECOG score of 0 at baseline worsened during the trial.)|||participants|||Number
2824594|NCT00349349|Secondary|Number of Participants With Complete Resolution of Lymphadenopathy|Participants with complete resolution of lymphadenopathy (disease involving the lymph nodes) were defined as those in whom all observed lymph nodes were of normal size (all nodes <1 centimeters) as determined by physical examination assessed by the investigator. All palpable lymph node sizes were recorded.|Baseline (Visit 2) to end of study (up to Week 24)|FAS. Data were provided for the number of participants with lymphadenopathy at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline lymphadenopathy remained free of lymphadenopathy during the trial.)|||participants|||Number
2824595|NCT00349349|Secondary|Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24|Participants with complete resolution of constitutional symptoms were those in whom no constitutional symptoms, such as night sweats, weight loss, and fever or extreme fatigue, were observed.|Baseline (Visit 2) and Week 24|FAS. Data were provided for the number of participants with constitutional symptoms at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline constitutional symptoms did not experience new constitutional symptoms during the trial period.)|||participants|||Number
2824596|NCT00349349|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)|Tumor size and change in tumor size will be measured by the absolute value of and the percent change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24 (Visit 14). Percent change from Visit 2 (Baseline, Week 0) = (value at Week 24 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 24 (Visit 14)|FAS|||percent change in tumor size||Full Range|Median
2824597|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts|"The peripheral blood for each participant was collected and analyzed for CD5+CD20+ cell counts. CD is cluster of differentiation, is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100."|Baseline (Visit 2) until Week 7 (Visit 9)|FAS|||percent change in cell counts||Full Range|Median
2824598|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts|"The peripheral blood for each participant was collected and analyzed for CD5+CD19+ cell counts. CD is cluster of differentiation, is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100."|Baseline (Visit 2) until Week 7 (Visit 9)|FAS|||percent change in cell counts||Full Range|Median
2824599|NCT00349349|Secondary|Overall Survival|OS is defined as the time from allocation to death. OS will also be subgrouped for responders and non-responders.|Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks)|FAS|||months||95% Confidence Interval|Median
2824600|NCT00349349|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months])|FAS|||months||95% Confidence Interval|Median
2824628|NCT00348790|Secondary|Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas|"Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal"|Every week while on study treatment until 30 days after last treatment.|Toxicities determined to be either grade 3 or grade 4 and at least possibly related to study drug are reported here.|||participants|||Number
2824601|NCT00349349|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression/death. Per the IRC, if the participant had progression between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity/other reason, new anti-cancer treatment, and death/progression after 2 or more missed visits in a row, the endpoint was censored. Clinical progression is not considered as progression endpoint.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS|||months||95% Confidence Interval|Median
2824602|NCT00349349|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS|||months||95% Confidence Interval|Median
2824603|NCT00349349|Primary|Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) were classified as responders, while those with stable disease (SD) and progressive disease (PD) were classified as non-responders. Per the NCIWG guideline (1996): CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, bone marrow sample as normocellular for age, <30% lymphocytes (LC), no lymphoid nodule; PR: a >=50% decrease in LC/lymphadenopathy; nPR: persistent nodules in bone marrow; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0 of Visit 2) until Week 24|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Participants not evaluable (NE) were due to patient withdraw, refusal, non-trial drug related AEs, and death|||participants|||Number
2824604|NCT00349336|Secondary|Terminal Half-life of Bevacizumab|Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||hr||Standard Deviation|Mean
2824605|NCT00349336|Secondary|Volume of Distribution of Bevacizumab at Steady State|Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||L||Standard Deviation|Mean
2824606|NCT00349336|Secondary|Time of Maximum Serum Concentration of Bevacizumab|Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||hr||Standard Deviation|Mean
2824607|NCT00349336|Secondary|Serum Clearance of Bevacizumab|Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||L/day||Standard Deviation|Mean
2824608|NCT00349336|Secondary|Minimum Serum Concentration of Bevacizumab at Steady State|Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||ug/ml||Standard Deviation|Mean
2824609|NCT00349336|Secondary|Maximum Serum Concentration of Bevacizumab at Steady State|Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||ug/mL||Standard Deviation|Mean
2824610|NCT00349336|Secondary|Steady-state Exposure of Bevacizumab From Time Zero to Tau|Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||day*ug/mL||Standard Deviation|Mean
2824611|NCT00349336|Primary|Weekly Steady-state Exposure of Bevacizumab|Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||day*ug/mL||Standard Deviation|Mean
2824612|NCT00349336|Secondary|Time Zero to Last Measurable Plasma Concentration of Bevacizumab|Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.|||day*ug/mL||Standard Deviation|Mean
2824613|NCT00348933|Secondary|Change in RBC Folate||Baseline, 1 year|Analysis per protocol|||ng/mL||Standard Deviation|Mean
2824614|NCT00348933|Secondary|Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine.||Baseline, 1 year|analysis per protocol|||mmol/L||Standard Deviation|Mean
2824615|NCT00348933|Primary|Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills|"Primary:~Bayley Scales of Infant Development measures Mental Developmental Index standard scores 0 (least skilled) - 100 (most skilled) Psychomotor Developmental Index standard scores 0 (least skilled - 10 (most skilled) Vineland Adaptive Behavior Scales (VABS), Communication standard scores 0 (least skilled) - 100 (most skilled) Daily Living Skills standard scores 0 (least skilled) - 100 (most skilled) Socialization standard scores 0 (least skilled) - 100 (most skilled) Motor Skills standard scores 0 (least skilled) - 100 (most skilled) Preschool Language Scale (PLS), Auditory Comprehension 0 (least skilled) - 100 (most skilled) Expressive Communication 0 (least skilled) - 100 (most skilled)"|Baseline, 1 year|Analysis per protocol|||units on a scale||Standard Deviation|Mean
2824616|NCT00348881|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.~Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received.|||Participants|||Number
2824617|NCT00348881|Primary|Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.|Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.|Day 0 to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.|||Participants|||Number
2824618|NCT00348881|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.|1 month post third vaccination|GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2824619|NCT00348881|Primary|Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.~Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.|||Participants|||Number
2824620|NCT00348816|Secondary|Correlation Between Velocity of Subsequent PSA Failure and Survival||5 years|N/A no study data was recorded for this outcome||||||
2824621|NCT00348816|Secondary|Overall Survival||5 years|N/A no data recorded||||||
2824622|NCT00348816|Secondary|Progression-free Survival Based on PSA Progression|Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.|5 years|One subject was not included in analysis due to taken off study due to non-compliance|||Participants|||Count of Participants
2824623|NCT00348816|Primary|Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.|Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..|5 years|Exceptions to group description: (1) one subject non-compliant and taken off study (not included in analysis); (2) one subject did not receive docetaxel #7 during radiation due to change in performance status; (3) one subject received only 1 post radiation docetaxel; (4) two subjects did not receive post radiation docetaxel #4.|||Participants|||Count of Participants
2824624|NCT00348790|Other Pre-specified|To Use the FACT BR Questionnaire to Measure Quality of Life|FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment|At baseline and then every time an MRI is performed while on study treatment.|Data not collected or analyzed.||||||
2824625|NCT00348790|Other Pre-specified|Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels|Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment|MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment|Data not collected and analyzed.||||||
2824626|NCT00348790|Secondary|Overall Survival (OS)|Overall Survival will be measured from the first treatment on study until death of any cause.|Every 2 months for up to 1 year after study treatment.|Number of patients with WHO grade II or WHO grade III meningioma.|||Months||Full Range|Median
2824627|NCT00348790|Secondary|Number of Months Patients Survive After Being Treatment on the Study.||From the date the first patient began treatment until the date the last patient became deceased.||||months||95% Confidence Interval|Median
2824629|NCT00348790|Secondary|To Correlate the Response Rates With Expression of Certain Types of Genes|Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes|At the end of study treatment|Data not collected and analyzed.||||||
2824630|NCT00348790|Secondary|Best Overall Response Rate (ORR)|"Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply.~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition"|Every 2 months for up to 1 year after study treatment.|3 patients not evaluable.|||Participants|||Count of Participants
2824631|NCT00348790|Secondary|Determine Efficacy (Radiographic and Clinical Improvement)|Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment|At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment|Data not collected. Statistical design of study was based on participation of patients with WHO grade I meningioma. Most patients enrolled in the study were WHO grade II and WHO grade III.||||||
2824632|NCT00348790|Primary|Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.|Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.|From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment||||Participants|||Count of Participants
2824633|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 91 patients are available for analysis|||percent change||Full Range|Median
2824634|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 201 patients are available for analysis.|||percent change||Full Range|Median
2824635|NCT00348686|Secondary|Change of Diastolic Blood Pressure (DBP)|"Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.~Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data."|At Baseline and 24 weeks|Last Observational carried forward|||mmHg||Full Range|Median
2824636|NCT00348686|Secondary|Change of Systolic Blood Pressure (SBP)|Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.|||mmHg||Full Range|Median
2824637|NCT00348686|Secondary|LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index|Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.|At Baseline and 24 weeks|Only 245 patients who have reliable Echocardiac data were analyzed.|||g/m^2||Full Range|Median
2824638|NCT00348686|Primary|Percent Change of B Type Natriuretic Peptides (BNP) Level|Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.|At Baseline and 24 weeks|Followed Intent-to-treat analysis|||Percent Change||Full Range|Median
2824639|NCT00348673|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.|||hrs||Full Range|Median
2824640|NCT00348673|Other Pre-specified|Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.|||ng/mL||Standard Deviation|Geometric Mean
2824641|NCT00348673|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)|AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.|0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2824642|NCT00348673|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.|Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.|||participants|||Number
2825012|NCT00344968|Secondary|Retinal Thickness|Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.|36 months||||microns||Standard Deviation|Mean
2824643|NCT00348673|Primary|Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8|Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.|Baseline, Day 8|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.|||log10 copies/mL||Standard Deviation|Mean
2824644|NCT00348595|Secondary|Plasma Concentration of Revilimid at Steady State|Mean plasma concentration (ng/mL) of Revilimid at steady state (Day 21 of second treatment cycle)|Day 21 of second treatment cycle|Data was only evaluable in 20/26 and 27/34 participants from the 5mg and 25mg arms, respectively.|||ng/mL||95% Confidence Interval|Mean
2824645|NCT00348595|Primary|Change in of PSA Slope|Mean change in PSA slope from baseline to 6 months. PSA slope was calculated using the regression of log PSA over 6 months in each patient. A negative mean change in PSA slope reflects a better outcome.|Change from baseline to 6 months post-intervention||||log PSA||95% Confidence Interval|Mean
2824646|NCT00348595|Primary|Number of Participants With Prostate-specific Antigen (PSA) Progression|Number of participants with greater than or equal to 25% increase in PSA at 6 months|6 months post-intervention||||Participants|||Count of Participants
2824647|NCT00348595|Primary|Safety, Feasibility and Tolerance of Revlimid as Assessed by Number of Participants Experiencing Grade 3 and 4 Adverse Events.|Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0|6 months post-intervention||||Participants|||Count of Participants
2824648|NCT00348556|Secondary|Change in Urinary Sodium Excretion at 24 Hours|The fractional excretion of sodium (FENa) measures the percent of filtered sodium that is excreted in the urine. This calculation is widely used to help differentiate prerenal disease (decreased renal perfusion) from acute tubular necrosis (ATN) as the cause of acute kidney injury (AKI, formerly called acute renal failure).|baseline, 24 hours after start of infusion|The data from the 3 subjects were incomplete and could not be analyzed.||||||
2824649|NCT00348556|Primary|Change in Glomerular Filtration Rate (GFR) at 24 Hours|Kidney function was to be measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|baseline, 24 hours after start of infusion|The data from the 3 subjects were incomplete and could not be analyzed.||||||
2824650|NCT00348374|Secondary|Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824651|NCT00348374|Secondary|Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824652|NCT00348374|Secondary|Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24|"Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction.~Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24."|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.|||scores on scale||Standard Deviation|Mean
2824653|NCT00348374|Secondary|Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)|Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.|||scores on scale||Standard Deviation|Mean
2824654|NCT00348374|Secondary|Crude Hypoglycemic Event Rate|Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||events per subject months|||Number
2824757|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment|Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration|Baseline, Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.|||mmHg||Standard Deviation|Mean
2824655|NCT00348374|Secondary|Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment|Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated * days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||subject months of treatment|||Number
2824656|NCT00348374|Secondary|Number of Total Hypoglycemic Events|Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||events|||Number
2824657|NCT00348374|Secondary|Number of Subjects With Hypoglycemic Events|Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||participants|||Number
2824658|NCT00348374|Secondary|Baseline Prandial Insulin Dose (at Each Meal) at Each Visit|Dose of inhaled insulin prior to each meal at each visit.|Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||mg||Standard Deviation|Mean
2824659|NCT00348374|Secondary|Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)|Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; Lispro international units (IU) were converted to milligrams (mg) equivalent; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||IU||Standard Deviation|Mean
2824660|NCT00348374|Secondary|Change From Baseline in Fasting Plasma Lipids|Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824661|NCT00348374|Secondary|Change From Baseline Weight at Each Visit|Change = mean body weight at observation minus mean body weight at Baseline.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF (all visits except Baseline); N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||kilograms||Standard Deviation|Mean
2824662|NCT00348374|Secondary|Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests|Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)[mg/L], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.|Week 12, Week 24|Due to cancellation of the EXUBERA program, too few patients participated to explore the markers of cardiovascular (CV) risks so these markers were not summarized.|||participants|||Number
2824663|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests|Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824664|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24|Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824665|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12|Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 12|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824802|NCT00346697|Secondary|Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks||||mg/dl||Inter-Quartile Range|Median
2824803|NCT00346697|Secondary|Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks||||mg/dl||Inter-Quartile Range|Median
2824804|NCT00346697|Secondary|Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks||||mg/dl||Inter-Quartile Range|Median
2824666|NCT00348374|Secondary|Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles|Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.|Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||mg/dL||Standard Deviation|Mean
2824667|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24|Number of subjects that attained HbA1c target levels of <7%, < 6.5%,and <6.0% at Week 24 without an episode of severe hypoglycemia.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||participants|||Number
2824668|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24|Number of subjects acheiving glycemic control: HbA1c target levels of <7.0%, <6.5%, and <6.0% at Week 24.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||participants|||Number
2824669|NCT00348374|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit|Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.|||percent||Standard Deviation|Mean
2824670|NCT00348374|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment|Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.|Baseline, Week 24 (End of Treatment)|Full analysis set (FAS): subjects who received at least one dose of study medication, had a baseline glycosylated hemoglobin A1c (HbA1c%) measurement, and had a post-baseline HbA1C measurement; last (post-baseline) observation carried forward (LOCF). Number of subjects with HbA1c values at Baseline and Week 24: Exubera® n=81, Lispro n=90.|||percent||Standard Deviation|Mean
2824671|NCT00348348|Secondary|Microbial Eradication|Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
2824672|NCT00348348|Secondary|Clinical Resolution|Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
2824673|NCT00348348|Primary|Microbial Eradication|eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 5 (+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
2824674|NCT00348348|Primary|Clinical Resolution|Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)|Day 5(+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated|||Participants|||Number
2824675|NCT00348309|Secondary|Change From Baseline in Alzheimer's Carer Quality of Life Instrument (ACQLI) Total Score|The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer's quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0-30 range. The total score ranged from 0 to 30, where 0 indicated absence of symptoms and higher score indicated worse outcomes; a negative change from baseline indicated improvement. Change from baseline was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 12, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824676|NCT00348309|Secondary|Number of Participants With Laboratory Potential Clinical Concern (PCC) Values|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Hematocrit 0.8, 1.2; hemoglobin 10-11, 16.5-18; Red blood corpuscles(RBC) 0.8, 1.2; mean corpuscular volume (MCV) 0.8, 1.2; mean corpuscular hemoglobin (MCH) 0.8, 1.2; White blood corpuscles (WBC) 3- absolute value, 15-absolute value, Red Cell Distribution Width (RDW) 0.8, 1.2; Lymphocytes 0.75, 1.5; Monocytes NA, 2; Eosinophil NA, 2; platelet count 100-absolute, 500-absoulte; segmented neutrophil (SN) 0.75, 1.5 and Total Neutrophil (TN) 0.75, 1.5.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Only those participants available at the specified time points were analyzed.|||participants|||Number
2824677|NCT00348309|Secondary|Change From Baseline in HbA1c at Week 12, Week 24 and Week 36|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Change from Baseline in HbA1c was calculated as the value at time point minus the value at Baseline.|Baseline (Week 0) and Week 12, 24 and 36|Safety population. Week 12, Week 24 and Week 36 assessments of HbA1c were only needed in participants whose HbA1c was >= 6.5% at screening or who had known Type 2 diabetes. Only those participants available at the specified time points were analyzed.|||Percent of total hemoglobin||Standard Deviation|Mean
2824689|NCT00348309|Secondary|Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48|ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2824805|NCT00346697|Primary|Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks||||mg/dl||Inter-Quartile Range|Median
2824678|NCT00348309|Secondary|Mean Change From Baseline in Short Term Memory Assessment Score|Short term memory assessment score was based on ADAS-Cog questionnaire (Question 1 and 7). ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in participants with AD. Question 1 (Word Recall) and Question 7 (Word Recognition) of the ADAS-Cog questionnaire were summed to get a short term memory assessment score. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). The total score ranged from 0 to 22 with 0 indicating absence of symptoms and higher scores indicating greater dysfunction; a negative change from baseline indicated improvement. Change from Baseline in short term memory assessment was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24, 36, 48 and 56|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2824679|NCT00348309|Secondary|Change From Baseline in Hematocrit Values|Blood samples of participants were collected for Hematocrit . Change from baseline in Hematocrit was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 36 and 48|Safety population. Only those participants available at the specified time points were analyzed.|||litre||Standard Deviation|Mean
2824680|NCT00348309|Secondary|Change From Baseline in Hemoglobin Values|Blood samples of participants were collected for Hemoglobin. Change from baseline in Hemoglobin was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 16, 36 and 48|Safety population. Only those participants available at the specified time points were analyzed.|||grams per litre (g/L)||Standard Deviation|Mean
2824681|NCT00348309|Secondary|Mean Change From Baseline in Weight|Body weight was measured at all visits, without shoes and wearing light clothing. Mean Change From Baseline in Weight was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Here, n=number of participants with observed data contributing to the analysis. Data for Site 040449 was not included in analysis due to audit finding.|||kilogram (kg)||Standard Deviation|Mean
2824682|NCT00348309|Secondary|Mean Change From Baseline in Heart Rate|Mean Change From Baseline in heart rate was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Only those participants available at the specified time points were analyzed. Data for Site 040449 was not included in analysis due to audit finding.|||beats per min (bpm)||Standard Deviation|Mean
2824683|NCT00348309|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP)|The plethysmographic method was used to measure BP throughout the study. Change in Systolic and Diastolic BP was calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56|Safety population. Only those participants available at the specified time points were analyzed. Data for Site 040449 was not included in analysis due to audit finding.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2824684|NCT00348309|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.|Up to Week 54|The safety population included all participants randomized to treatment and received at least one dose of study medication.|||Participants|||Number
2824685|NCT00348309|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Change from Baseline in HbA1c was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
2824686|NCT00348309|Secondary|Change in CDR-SB Total Score at Week 54 Compared to Week 48|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change was calculated as endpoint value (Week 54) minus Week 48 value.|Week 48 and 54|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824687|NCT00348309|Secondary|Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48|ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change was calculated as endpoint value (Week 54) minus Week 48 value.|Week 48 and 54|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824688|NCT00348309|Secondary|Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 12, 24, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2824837|NCT00346268|Secondary|Amount of Blood Loss|Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.|48 hours post surgery|FAS|||g/dL||Standard Deviation|Mean
2824690|NCT00348309|Secondary|Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility|"The EQ-5D Proxy is a two part scale that evaluated the participant's health status via Thermometer and Utility scores. The Thermometer score was the caregiver's rating of the participant's overall health status on a VAS (0 [worst possible status] to 100 [best imaginable status]). The Utility score was a caregiver rating of health status on dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression] where '1' indicated better health state (no problems); '3' indicated worst health state (confined to bed). Total possible score was the sum of individual items, ranged from 5 to 15; lower score indicated a better health state and higher score indicated greater severity of symptoms. A positive change from baseline indicated improvement in the Thermometer score and a negative change from baseline indicated improvement in the Utility score. Change from baseline is calculated as endpoint value minus the baseline value."|Baseline (Week 0), Week 12, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824691|NCT00348309|Secondary|Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented patients. RUD assessd both formal and informal resource use of the patient and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 corresponds to the number of hours during the last month the caregiver spent assisting the patient with toilet visits, eating, dressing, grooming, walking and bathing and Q2 corresponds to the number of hours during the last month the caregiver spent assisting the patient with shopping, food preparation, housekeeping, laundry, transportation, taking medication and managing financial matters. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented.|Baseline (Week 0), Week 12, 24, 36 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||hours||Standard Error|Least Squares Mean
2824692|NCT00348309|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Total Score|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. The scale was completed by the investigator, based on the performance of the participant, and took approximately 5 to 10 minutes to administer. The scores from 11 tests were combined to obtain the total score. The total scores range from 0 to 30, with lower scores indicating greater cognitive impairment and higher score indicating better outcome; a positive change from screening indicated an improvement. The total MMSE score for participants at screening was between 10 and 26, inclusive, in order to be eligible to participate in the trial. Change from screening is calculated as endpoint value minus the screening value.|Screening (Week -4) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824693|NCT00348309|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824694|NCT00348309|Secondary|Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The scale includes 23 items relating to instrumental activities of daily living and 17 items relating to basic self-care. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. Total score was obtained by adding the rating for each question and converting this total score out of 100. The total score ranged from 0 to 100, where higher score indicated better function and lower score indicated greater severity of symptoms; a positive change from baseline indicated an improvement. Change from baseline is calculated as endpoint value minus the baseline value.|Baseline (Week 0), Week 8, 16, 24 and 48|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2824695|NCT00348309|Primary|Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4's: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824717|NCT00348140|Secondary|Change in CDR-SB Total Score for Observed Cases at Week 54 Compared to Week 48|"The CDR-SB was a validated clinical assessment of global function in participants with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). It was of interest to compare the single blind phase data between the treatment groups defined based on the double blind treatment group. This analysis only included participants who received at least one dose of single-blind medication. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented."|Week 48 and Week 54|ITT population. Only those participants available at that particular time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2824696|NCT00348309|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48|ADAS is a performance-based test that measures specific cognitive and behavioral dysfunctions in participants with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. Change from baseline is calculated as Week 48 value minus the baseline value. APOE4 negative, All except E4/E4's: comprised of APOE4 negative and E4 heterozygote and full population was analyzed for this outcome measure. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the genetic subgroups. Least square mean is entered for adjusted mean.|Baseline (Week 0) and Week 48|ITT population included all the participants who were randomized to treatment, who had received at least one dose of study medication and who had at least one post baseline efficacy assessment. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2824697|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Weeks 12 and 52|ITT set. NRI method was used to impute the missing values.|||Subjects|||Number
2824698|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at both Week 12 and Week 52.|Weeks 12 and 52|Analysis was on ITT subjects who completed the Double Blind period and had Week 52 evaluations while in the Double Blind period. NRI method was used to impute the missing values.|||Subjects|||Number
2824699|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 52|ITT set. NRI method was used to impute the missing values.|||Subjects|||Number
2824700|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at Week 52.|Week 52|The secondary efficacy analysis included the ITT subjects who had mucosal ulceration at screening. NRI method was used to impute the missing values.|||Subjects|||Number
2824701|NCT00348283|Secondary|Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12|Clinical remission is defined as a CDAI less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 12|ITT set. NRI method was used to impute the missing values.|||Subjects|||Number
2824702|NCT00348283|Primary|Number of Subjects Without Mucosal Ulceration at Week 12|Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.|Week 12|Analysis was on ITT subjects with mucosal ulceration at Screening. Subjects who did not have endoscopy at Week 12 were considered to have mucosal ulceration at Week 12 (NRI). If subjects had endoscopy at Week 8, the endoscopy results from Week 8 were carried forward to Week 12 for the primary efficacy analysis.|||Subjects|||Number
2824703|NCT00348140|Secondary|Change From Baseline in Short Term Memory Assessment|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Questions 1 (word recall) and 7 (word recognition) of ADAS-Cog questionnaire was summed to get a short term memory assessment. The score for Question 1 was calculated as the mean number of words not recalled over the trials for which data was available. If data for all three trials was missing, or if the score for Question 7 was missing then the short term memory score will also be set to missing. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented.|Baseline (Week 0) and upto Week 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on an scale||Standard Error|Least Squares Mean
2824704|NCT00348140|Secondary|Change From Baseline in HbA1c up to Week 54|Blood samples were collected for assessments of HbA1c levels at Baseline, Weeks 12, 24, 36, 48, 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0.|Baseline (Week 0) and Weeks 12, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
2824705|NCT00348140|Secondary|Changes From Baseline in ECG Parameters- RR Interval, QT Interval, QTcB, QTcF, PR Interval and QRS Duration|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the participant had rested in the supine position in a quiet room (no TV, minimal talking) for atleast 10 minutes. The ECG parameters includes PR interval, QRS duration, QT - uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval. The assessments were performed at Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||MSEC||Standard Deviation|Mean
2824706|NCT00348140|Secondary|Changes From Baseline in Electrocardiogram (ECG) Parameters- HR|Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the participant had rested in the supine position in a quiet room (no TV, minimal talking) for atleast 10 minutes. The ECG parameters includes HR. The assessments were performed at Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value . Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Beats per minute (BPM)||Standard Deviation|Mean
2824707|NCT00348140|Secondary|Any Time on Treatment Differences in Frequencies of Clinical Chemistry Data Outside the Reference Range|Clinical chemistry parameters were identified as of PCC (High, Low), if values were out of RR: Alanine amino transferase (ALT,none-120 [250percent upper limit of RR, ULRR ]),Album in (0.75-2),Aldolase(1.1-1.1),Aspartate amino transferase (AST,none-105 (3-64y),137.5(65+y),>250 percent ULRR), Alkaline phosphatase(ALP,none-312.5 (20+y),>250percent ULRR),blood urea nitrogen(BUN)/Creatinine ratio(none-1.25),BUN(none-11),Chloride(80-115),Calcium (0.75-1.25),Carbon dioxide(CO2,15-40) content,Creatinine (22,<50percent lower limit of RR [LLRR ]-155, >125percent ULRR),Creatine phosphokinase(CPK,none-1.25),Gamma glutamyl transferase(GGT,none-2.5),Glucose (3.6-7.8),HbA1C, High density lipoprotein (HDL,0.65-none),Lactate dehydrogenase (LDH,none -2), Low density lipoprotein(LDL,none-1.25),Magnesium (0.5-2),Potassium (3-5.5),Phosphorus inorganic(0.5-1.5), Sodium (130-150), Total protein (0.8-1.5),Total cholesterol(none -1.5),Direct Billirubin.|Upto Week 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2824708|NCT00348140|Secondary|Any Time on Treatment Differences in Frequencies of Hematology Data Outside the Reference Range|Haematology parameters were identified as of PCC (high [H], low [L]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC , 0.8-1.2), hemoglobin (L: female [F]:10, male [M]:11; H: F:16.5-AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), Total neutrophils (ANC- absolute Neutrophil count) (0.75-1.5), lymphocytes (0.75-1.5), monocyte s (0.75-2), eosinophils (none -2), basophils (none -2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC , 0.8-1.2), red cell distribution width (RDW, 0.8-1.2), Neutrophil bands (none-1) and segmented neutrophils (0.75-1.3). Full population data was presented.|Up to Week 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2824709|NCT00348140|Secondary|Change From Baseline in Hematocrit|Hematology parameters were assessed at Baseline and up to Week 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0.|Baseline (Week 0) and Weeks 4, 16, 36, 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
2824710|NCT00348140|Secondary|Change From Baseline in Hemoglobin|Hematology parameters were assessed at Baseline, Weeks 4, 16, 36, 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 16, 36, 48|Safety population. Only those participants available at the indicated time points were analyzed.|||Gram\Liter (G\L)||Standard Deviation|Mean
2824711|NCT00348140|Secondary|Change From Baseline in Weight|Body weight was measured at all visits, without shoes and wearing light clothing. The assessment was performed at Baseline, Weeks 4, 8, 12, 16, 24, 36, 48, 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 24, 36, 48, 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Kilograms (Kg)||Standard Deviation|Mean
2824712|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Heart Rate (HR)|HR of participants were recorded in sitting posture as vital sign at each visit. The HR values were identified as of potential clinical concern if the values were out of the reference range (50 to 100 beats per minute) or meet a change from baseline criterion. The change from baseline criterion for HR, was increase from Baseline (high) if increased by more than or equal to (>=) 30 from Baseline; decrease from Baseline (low) if decreased by >= 30 from Baseline. Baseline was defined as value at Week 0. Full population data was presented.|Upto Week 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2824713|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP of participants were recorded in sitting posture as vital sign at each visit. The blood pressure (BP) values were identified as of potential clinical concern if the values were out of the reference range (for SBP, 90 to 140 mmHg and DBP, 50 to 90 mmHg) or meet a change from baseline criterion. The change from baseline criterion for SBP, was increase from Baseline (high) if increased by more than or equal to (>=) 40 mm Hg from Baseline; decrease from Baseline (low) if decreased by >= 30 mmHg from Baseline. For DBP, increase from baseline (high) if increased by >=30 mmHg from baseline; decrease from Baseline (low) if decreased by >= 20 mmHg from Baseline. Baseline was defined as value at Week 0.|Upto Week 54|Safety population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2824714|NCT00348140|Secondary|Number of Participants With Change From Baseline in Vital Signs of Clinical Concern at Any Time on Treatment- Weight|Body weight was measured at all visits, without shoes and wearing light clothing. The assessment was performed a t Baseline and up to Week 54. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Upto Week 54|Safety population. Only those participants available at the indicated time point were analyzed.|||Participants|||Count of Participants
2824715|NCT00348140|Secondary|Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Severity of AEs|AE was defined as any untoward medical occurrence in a participant temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that, at any dose results in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was considered as medically significant.|Upto Week 48|Safety population consisted of all participants randomized to treatment who had taken at least one dose of study medication. This population was used for analysis of safety data.|||Participants|||Count of Participants
2824716|NCT00348140|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48|Blood samples were collected for assessments of HbA1c levels at Baseline and up to Week 48. Change from Baseline was calculated as value at scheduled time point minus Baseline value . Baseline was defined as value at Week 0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Full population data was presented.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at that particular time point were analyzed.|||Percentage||Standard Error|Least Squares Mean
2824718|NCT00348140|Secondary|Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. It was of interest to compare the single blind phase data between the treatment groups defined based on the double blind treatment group. This analysis only included participants who received at least one dose of single-blind medication. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Week 48 and Week 54|ITT population. This analysis will only include participants who received at least one dose of single-blind medication. Only those participants available at that particular time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2824719|NCT00348140|Secondary|Change From Baseline in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score|The ACQLI is an assessment of caregiver quality of life. This instrument consisted of 30 questions exploring various aspects of carer's quality of life. Each of the questions had two point response, and the 30 questions were summed to provide a total score. Items were assumed to be unidimensional (i.e., represent a single variable) and were scored 0/1 (false/true) before summation into a total score with a 0-30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0-100 (100: worse). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824720|NCT00348140|Secondary|Change From Baseline in EQ-5D Scale Total Score- Utility Score|The EQ-5D Proxy is an assessment of quality of life and utility benefit. The EQ-5D Proxy is composed of two parts: part one is the five dimensional Health State Classification. The Utility score is a caregiver rating of health status on dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Answers to each question were responded to on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824721|NCT00348140|Secondary|Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Scale Total Score- Thermometer Score|The EQ-5D Proxy is an assessment of quality of life and utility benefit. The EQ-5D Proxy is composed of two parts: part two is the visual analogue scale 'Thermometer'. Caregivers are asked to respond as they feel the participant would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 'Thermometer' has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824722|NCT00348140|Secondary|Change From Baseline in Domains of the Resource Utilization in Dementia Scale (RUD)- Q1 and Q2 Caregiver Hours|The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented patients. RUD assessd both formal and informal resource use of the patient and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 corresponds to the number of hours during the last month the caregiver spent assisting the patient with toilet visits, eating, dressing, grooming, walking and bathing and Q2 corresponds to the number of hours during the last month the caregiver spent assisting the patient with shopping, food preparation, housekeeping, laundry, transportation, taking medication and managing financial matters. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Baseline (Week 0) and Week 12, 24, 36, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Caregiver hours||Standard Error|Least Squares Mean
2824723|NCT00348140|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|"NPI is an assessment of frequency and severity of behavioral disturbances in dementia that comprised of 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety, aberrant motor activity. Participant's caregiver asked about behavior in participant. If Yes, informant then rated both severity on a 3-point scale, 1-mild to 3-severe (total range: 0-36) and frequency using a 4-point scale, 1-occasionally to 4-very frequently. Total score was frequency × severity. Distress was scored on 5-point scale, 0-no distress to 5-very severe or extreme. Total NPI score was calculated by adding all domain scores; NPI total score: 0-144 and NPI distress score: 0-60, higher scores indicated more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Adjusted means were presented. Full population data was presented."|Baseline (Week 0) and Week 8, 16, 24, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824743|NCT00347919|Secondary|Time to Response (Complete or Partial Response) in Cohort 1 and Cohort 2|Time to response is defined as the time from randomization to the time of first documented evidence of a complete (CR) or partial response (PR). The time to response will depend on when the response is counted as starting. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the target dimensions of the target lesions taking as a reference the baseline sum.|The time from randomization to the time of first documented evidence of complete or partial response (up to 81.14 weeks for Cohort 1 and 44.29 weeks for Cohort 2)|MITT Population|||weeks||95% Confidence Interval|Median
2824724|NCT00348140|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score|The DAD assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assessed a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD Total score /Total number of applicable items) multiplied by 100. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 48|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824725|NCT00348140|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Total Score|The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the participant. Change from screening was calculated as value at scheduled time point minus screening value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Full population data was presented.|Screening (Week -4) and Week 48|ITT population. Only those participants available at that particular time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2824726|NCT00348140|Secondary|Change From Baseline in CDR-SB Score at Weeks 12, 24 and 36|"The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. It was calculated at Weeks 12, 24 and 36. Full population data was presented."|Baseline (Week 0) and Week 12, 24, 36|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824727|NCT00348140|Secondary|Change From Baseline in ADAS-Cog Total Score at Weeks 8, 16, 24 and 36|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. It was calculated at Weeks 8, 16, 24 and 36. Full population data was presented.|Baseline (Week 0) and Week 8, 16, 24, 36|ITT population. Number of participants with observed data contributing to the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2824728|NCT00348140|Primary|Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort|"The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups."|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
2824729|NCT00348140|Primary|Change From Baseline in CDR-SB Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort|"The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups."|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
2824730|NCT00348140|Primary|Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort|"The CDR-SB was a validated clinical assessment of global function in patients with AD. Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, can be added together to give the CDR-Sum of Boxes which ranges from 0 to 18 (severe impairment). Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. Primary inference will be based on the week 48 treatment differences obtained from the MMRM model. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups."|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
2824838|NCT00346268|Secondary|Time to Last Administration of Morphine|Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).|baseline (end of surgery) to 48 hours post surgery|FAS; Number of participants analyzed (N)=participants with evaluable data|||hours||Full Range|Median
2824731|NCT00348140|Primary|Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in Full Population Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
2824732|NCT00348140|Primary|Change From Baseline in ADAS-Cog Total Score at Week 48, as a Function of APOE ε4 Status in All Except E4/E4s Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value a t Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
2824733|NCT00348140|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 48, as a Function of APOE ε4 Status in APOE4 Negatives Cohort|The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores range from 0 to 70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Week 0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for statistical tests in the two RSG dose groups and the genetic subgroups.|Baseline (Week 0) and Week 48|ITT population comprised of all participants randomized to treatment, who had taken at least one dose of study medication and who had at least one post baseline efficacy assessment. Number of participants with observed data contributing to the analysis have been presented.|||Scores on a scale||Standard Error|Least Squares Mean
2824734|NCT00347958|Other Pre-specified|Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®|Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.|Day 28 post-vaccination|Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.|||Percentage of Participants|||Number
2824735|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2824736|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2824737|NCT00347958|Primary|Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination|Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.|0-14 days post-vaccination|"Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.~The solicited systemic reaction, malaise was not collected in the previous studies."|||Percentage of Participants|||Number
2824738|NCT00347932|Secondary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized.|||Participants|||Number
2824739|NCT00347932|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized|||Participants|||Number
2824740|NCT00347932|Primary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 5 +/- 1 day|Modified Intent to treat population, culture confirmed, as randomized.|||Participants|||Number
2824741|NCT00347932|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 5 +/- 1 day|Modified intent to treat population, culture confirmed, as randomized|||Participants|||Number
2824742|NCT00347919|Secondary|Percentage of Participants With Progressive Disease at Week 12|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Participants were classified as having PD if their response at Week 12 was unknown or missing. Per Response Evaluation Criteria In Solid Tumors (RECIST), PD is defined as a >=20% increase in target lesions. IRC, independent review committee.|Week 12|Cohort 2 MITT Population|||percentage of participants|||Number
2824839|NCT00346268|Secondary|Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.|48 hours post surgery|FAS|||mL||Standard Deviation|Mean
2824744|NCT00347919|Secondary|Duration of Response in Cohort 1|Duration of response is defined as the length of time from the time from the first observation of response until progression of disease or death. Duration of response depends on two things: (1) when response is counted as starting; (2) when response is counted as ending.There were insufficient data to adequately assess duration of response for Cohort 2. IRC, independent review committee. For participants who do not progress or die, duration of response was censored at the date of last adequate assessment.|Time from first documented evidence of complete or partial response until the first documented sign of disease progression or death due to any cause (up to 106.71 weeks)|MITT Population|||weeks||Inter-Quartile Range|Median
2824745|NCT00347919|Secondary|Response at Week 12 for Cohort 1 and Cohort 2|The percentage of participants achieving either a complete (CR) or partial (PR) tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) is presented. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee. Participants with an unknown or missing response were treated as non-responders.|Week 12|MITT Population|||percentage of participants|||Number
2824746|NCT00347919|Secondary|Overall Survival for Cohort 1|Overall survival (OS) is defined as the time from randomization until death due to any cause. Participants who are alive as of the date of last contact are censored. There was insufficient follow-up to adequately assess OS for Cohort 2. Median OS cannot be presented for the lapatinib arm because the upper bound of the 95% confidence interval is undefined due to insufficient follow-up.|Randomization until death due to any cause (up to 106.43 weeks)|MITT Population|||weeks||95% Confidence Interval|Median
2824747|NCT00347919|Primary|Percentage of Participants With Progressive Disease at Week 12 in Cohort 1|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.|Week 12|Cohort 1: Modified Intent-to-Treat (ITT) Population (all randomized, centrally confirmed, ErbB2 FISH-positive participants).|||percentage of participants|||Number
2824748|NCT00347776|Secondary|Adverse Events|At 6 weeks participants/family members were asked about any hospitalization,death,ocular complaints, gastrointestinal illness or other specific illness or any clinic visit within six weeks of receiving surgery.|6 weeks||||Participants|||Count of Participants
2824749|NCT00347776|Secondary|Surgical Failure|The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.|6 weeks||||Participants|||Count of Participants
2824750|NCT00347776|Primary|Recurrent Trichiasis Between Two Azithromycin Arms|"Recurrence of trichiasis :Clinical assessment for recurrence was done by looking for one or more eye lashes touching globe or evidence of epilation.~If there was evidence of epilation or if one or more eye lashes were touching the globe, it was considered as recurrence of trichiasis."|Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery||||Participants|||Count of Participants
2824751|NCT00347776|Primary|Recurrent Trichiasis in Tetracycline and Azithromycin Groups|Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.|Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery|Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants)|||Participants|||Count of Participants
2824752|NCT00347438|Primary|Complete Pathologic Response Rate (cPR)|Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||percentage of participants|||Number
2824753|NCT00347438|Primary|Complete Clinical Response Rate (CCR)|Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||percentage of participants|||Number
2824754|NCT00347438|Primary|Partial Clinical Response Rate (PR)|Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||participants|||Number
2824755|NCT00347438|Primary|Overall Clinical Response Rate (OCR)|Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.|||percentage of participants|||Number
2824756|NCT00347360|Secondary|Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)||Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.|||participants|||Number
2824840|NCT00346268|Primary|Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.|24 hours post surgery|Full Analysis Set Population (FAS): participants who were randomized to treatment|||mL||Standard Deviation|Mean
2824758|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.|Night BP, Baseline, Week 6|: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
2824759|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM|Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.|Afternoon BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
2824760|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.|Morning BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
2824761|NCT00347360|Secondary|Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.|Refer to Adverse Event section for safety information.|Weeks 1 through 48|||||||
2824762|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)|Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak > 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||trough:peak ratio x 100%|||Number
2824763|NCT00347360|Secondary|Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)|Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Error|Mean
2824764|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough Systolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
2824765|NCT00347360|Secondary|Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
2824766|NCT00347360|Primary|Change From Baseline to Week 6 in Trough Diastolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population|||mmHg||Standard Deviation|Mean
2824767|NCT00347360|Primary|Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).|Baseline, Week 6.|ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population.|||mmHg||Standard Deviation|Mean
2824768|NCT00347308|Primary|Eyebrow Position|Position of eyebrow at the medial canthus relative to orbital rim|At time of evaluation||||mm||Standard Deviation|Mean
2824769|NCT00347269|Secondary|Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9||Measured at Month 18|||||||
2824770|NCT00347269|Primary|BSI-12 (Anxiety and Somatization Subscales)|12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms|Measured at Month 18||||number of responders|||Number
2824771|NCT00347022|Primary|Creatinine Clearance|The variation of creatinine clearance before and after the product injection was measured|between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration||||percent change||Standard Deviation|Mean
2829095|NCT00308711|Secondary|Duration of Stay in Minutes in Labor and Delivery Suite|Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.|5760 minuts||||minutes||Standard Deviation|Mean
2824772|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Per Protocol Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Per Protocol (PP) Population: all participants in the ITT Population with interpretable liver biopsies at baseline and at the 36-month follow-up visit and without major violations of the protocol|||participants|||Number
2824773|NCT00347009|Secondary|Number of Participants Who Were HBsAg Positive at Baseline, With HBsAg Seroconversion at Months 12, 24, and 36|HBsAg seroconversion was defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb).|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
2824774|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Surface Antigen (HBsAg) Positive at Baseline and Developed Undetectable Levels of HBsAg at Months 12, 24, and 36|HBsAg positive was defined as the presence of a detectable level of HBsAg.|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
2824775|NCT00347009|Secondary|Number of Participants Who Were HBeAg Positive at Baseline, With HBeAg Seroconversion at Months 12, 24, and 36|HBeAg seroconversion was defined as a decrease in HBeAg to undetectable levels and a gain of detectable levels of Hepatitis B envelope antibody (HBeAb).|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
2824776|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Envelope Antigen (HBeAg) Positive at Baseline and Developed Undetectable Levels of HBeAg at Months 12, 24, and 36|HBeAg positive was defined as the presence of a detectable level of HBeAg.|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
2824777|NCT00347009|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Months 12, 24, and 36|ALT levels were measured as part of the liver function tests. Participants with ALT normalization at each visit were defined as those with a value below the upper limit of the normal (ULN) range for ALT provided by that site at the respective visit.|Months 12, 24, and 36|ITT Population|||participants|||Number
2824778|NCT00347009|Secondary|Number of Participants With Virological Breakthrough at Months 12, 24, and 36|Virological breakthrough was defined as an increase in serum HBV DNA levels by more than 1 log10 copies/ml from treatment nadir, i.e., the lowest HBV DNA value during the study.|Months 12, 24, and 36|ITT Population|||participants|||Number
2824779|NCT00347009|Secondary|Number of Participants With Undetectable HBV DNA at Months 12, 24, and 36|Undetectable HBV DNA was defined as an HBV DNA level below the lower limit of detection (LLOD) of 300 copies/ml.|Months 12, 24, and 36|ITT Population|||participants|||Number
2824780|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^4 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^4 copies/ml.|Months 12, 24, and 36|ITT Population|||participants|||Number
2824781|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^3 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^3 copies/ml.|Months 12, 24, and 36|ITT Population|||participants|||Number
2824782|NCT00347009|Secondary|Change From Baseline in Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level at Months 12, 24, and 36|The levels of HBV DNA in serum were measured using the Amplicor Cobas assay by Roche Diagnostics (detection limit 300 copies/milliliter [ml]). Changes from baseline in the serum HBV DNA level at Months 12, 24 and 36 were calculated as Month 12 minus baseline, Month 24 minus baseline, and Month 36 minus baseline respectively. Change is reported in log10 units.|Baseline and Months 12, 24, and 36|ITT Population|||log10 copies/ml||Standard Deviation|Mean
2824783|NCT00347009|Secondary|Number of Participants With a Reduction From Screening of at Least 2 Points in the Knodell Necroinflammation Score at Month 36|The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) periportal and/or bridging necrosis (scores from 0 to 10); (II) intralobular degeneration and focal necrosis (scores from 0 to 4); (III) portal inflammation (scores from 0 to 4); (IV) fibrosis (scores from 0 to 4). The Knodell necroinflammation score is the sum of scores from Parts I-III, hence a range of 0 to 18, and measures the degree of acute necroinflammatory activity in the liver.|Screening and Month 36|ITT Population|||participants|||Number
2824784|NCT00347009|Secondary|Number of Participants With a Reduction From Baseline in the Child-Pugh Score by 2 Points or More at Months 12, 24, and 36|The Child-Pugh score (modified version for scoring prothrombin time against reference range) was used in the study to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease: encephalopathy, ascites, albumin, prothrombin time, and bilirubin. Each measure is scored on a scale of 1-3, with 1 being normal and 3 indicating most severe derangement. The total score for the Child-Pugh assessment was calculated as the sum of the 5 contributing scores, with a score range of 5 (best prognosis) to 15 (worst prognosis).|Baseline and Months 12, 24, and 36|ITT Population|||participants|||Number
2824785|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication, regardless of whether the participants completed the planned duration of the study|||participants|||Number
2824841|NCT00346216|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)|"VAS question How much pain do you have was graded on a scale from 0 to 100 with 0 indicating No pain and 100 indicating Worst possible pain."|ITT and MITT Population - Baseline to 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Number of participants||Standard Deviation|Mean
2824786|NCT00346905|Primary|Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.|Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction.|3 years either baseline to 12m, baseline to 24m, baseline to 36m|Overall Number of Participants Analyzed (16) will differ at 12m, 24m, and 36m intervals due to patients who were available at the given follow-up interval.|||% of Participants|||Number
2824787|NCT00346775|Secondary|Number or Participants With Preference of Nasal Sprays (Nasarel or Beconase AQ) at the End of the Last Cross-over Period Using the Preference Module of the EARNS-Q|The participants with preference of nasal sprays (Nasarel or Beconase AQ) at the end of the last cross-over period was planned to be analyzed using the preference module of the EARNS-Q. The data for this outcome measure was not collected and the result summary was not generated.|Up to Day 23|Efficacy Population. No participants were analyzed for this outcome measure.||||||
2824788|NCT00346775|Secondary|Mean rTNSS Over Period|The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a 4 point scale ranging from 0 to 3. Each individual symptom was evaluated using a scale of 0 (none; symptom is not present), 1 (mild; sign/symptom clearly present but minimal awareness; easily tolerated), 2 (moderate; definite awareness of sign/symptom that is bothersome but tolerable), or 3 (severe; sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The rTNSS ranges from 0 (none) to 12 (severe). Higher score represents greater severity of symptoms. The reflective assessment of the TNSS scores the four nasal symptoms over the previous 12 hours and are assessed in the morning and evening. The participants themselves scored nasal symptoms in a diary card. The analysis was done based on the rTNSS averaged over the two weeks of the treatment period.|Day 1 to 8 of each treatment period|Efficacy population was defined as all participants who completed both treatment periods, who had efficacy and questionnaire data recorded in both treatment periods, and who had recorded sufficient efficacy data to calculate daily rTNSS.|||Score on scale||Standard Error|Least Squares Mean
2824789|NCT00346775|Primary|Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores|The 28 items of the EARNS-Q experience module assess 14 attributes with regard to their product rating and their importance of efficacy, SP, DC and SD. The EARNS-Q preference module consists of additional 15 items that evaluate preference by comparing two products based on the same 14 experience attributes as well as on OPP. Change in EARNS-Q Experience Module domain scores was calculated as scores in TP2 minus scores in TP1. If the change in EARNS-Q Experience Module domain scores is +ve, product in TP2 is preferred and vice-versa. A higher product rating for one of the sprays lead to a preference for that spray. The EARNS-Q preference module was assessed only once, at the end of TP2. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product).|Day 1 to Day 23|ITT Population. Pearson correlations was used in correlational analyses.|||correlation coefficient|||Number
2824790|NCT00346775|Primary|Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores|EARNS-Q Preference Module consists of efficacy, sensory perception (SP), device characteristic (DC), spray delivery (SD), overall product preference (OPP) and total domain. TSQM consists of global satisfaction (GS), convenience, effectiveness and side-effects (SE) domains. Positive (+ve) correlation of EARNS-Q preference scores with change on TSQM domains indicate that preference for a product is associated with better TSQM scores. Negative (-ve) correlation with mean daily rTNSS indicate that preference for a product is associated with lower mean daily rTNSS. Change in TSQM domain scores and mean daily rTNSS was calculated as scores in Treatment Period (TP) 2 minus scores in TP1; change in TSQM is +ve, product in TP2 is preferred, vice-versa; change in rTNSS is -ve, product administered in TP2 is preferred, vice-versa.|Day 1 to Day 23|Intent- to- Treat (ITT) Population was defined as all the participants who were randomized to the study drug. Pearson correlations was used in correlational analyses.|||correlation coefficient|||Number
2824791|NCT00346697|Secondary|Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||seconds||Inter-Quartile Range|Median
2824792|NCT00346697|Secondary|Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||seconds||Inter-Quartile Range|Median
2824793|NCT00346697|Secondary|Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||mcg/L||Inter-Quartile Range|Median
2824794|NCT00346697|Secondary|Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||ng/mL||Inter-Quartile Range|Median
2824795|NCT00346697|Secondary|Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
2824796|NCT00346697|Secondary|Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
2824797|NCT00346697|Secondary|Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
2824798|NCT00346697|Secondary|Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||pg/mL||Inter-Quartile Range|Median
2824799|NCT00346697|Secondary|Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data|||ng/ml||Inter-Quartile Range|Median
2824800|NCT00346697|Secondary|Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data|||cells/cc||Inter-Quartile Range|Median
2824801|NCT00346697|Secondary|Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data|||units on a scale||Inter-Quartile Range|Median
2824806|NCT00346632|Secondary|Disease Response|"Disease response (i.e., complete or partial remission) based on standard criteria:~Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.~Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.~VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) [updated March 2002; cited 2005 Nov 16]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf"|Day 14 (Arm A) or Day 28 (Arm B) for all cycles||||number of responders|||Number
2824807|NCT00346632|Secondary|Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)||Day 1 and either Day 14 or Day 28 of Cycle 1||||Ratio of hr*ng/mL||Standard Deviation|Mean
2824808|NCT00346632|Secondary|Terminal Half Life (t 1/2)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||hours||Standard Deviation|Mean
2824809|NCT00346632|Secondary|Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||hr*ng/mL||Standard Deviation|Mean
2824810|NCT00346632|Secondary|Time to Peak Plasma Concentration (Tmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||hours||Standard Deviation|Mean
2824811|NCT00346632|Secondary|Observed Peak Plasma Concentration (Cmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1||||ng/mL||Standard Deviation|Mean
2824812|NCT00346632|Primary|Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0|In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.|Baseline up to Cycle 2, Day 1||||participants|||Number
2824813|NCT00346476|Primary|Number of Participants With HIV Infection||At Year 5||||participants|||Number
2824814|NCT00346476|Secondary|Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants||At Year 5|||||||
2824815|NCT00346476|Secondary|Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants||Year 1 to Year 5|||||||
2824816|NCT00346476|Secondary|Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART||Year 1 to Year 5|||||||
2824817|NCT00346476|Secondary|Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants||Year 1 to Year 5|||||||
2824818|NCT00346476|Primary|Number of Participants With Microbiologically Confirmed Tuberculosis Infection||At Year 5||||participants|||Number
2824819|NCT00346398|Secondary|Time to First Onset of Asthma|Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.|From Treatment Initiation to Month 36 Status Post Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial|||Months||Standard Error|Mean
2824820|NCT00346398|Secondary|Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion|Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial|||participants|||Number
2824821|NCT00346398|Primary|Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion|"Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.~A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.~A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization."|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial|||participants|||Number
2824822|NCT00346333|Secondary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity|Annual change in number of letters read.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis and included all reliable, non-missing values. The unit of analysis was the eye.Each patient contributed 2,1, or 0 eyes with non-missing data.|||Change in letters read per year||Standard Error|Mean
2824823|NCT00346333|Secondary|Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.|Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;analyses of 30 Hz ERG data included those who had an initial amplitude of 0.68 microvolts or greater in at least 1 eye and data were censored when values declined to less than 0.34 microvolts. The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.|||ln (microvolts)/year||Standard Error|Mean
2824857|NCT00346164|Primary|Probability for Event Free Survival.|Probability of no relapse, secondary malignancy or death after 5 years since enrollment.|5 years|Ineligible patients are excluded as well as patients who were treated on the incorrect arm.|||Probability of EFS at 5 years||95% Confidence Interval|Number
2824858|NCT00346151|Secondary|Proportion of Participants With Post-transplant Diabetes Mellitus||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2824824|NCT00346333|Secondary|Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target obtained with the 30-2 and 60-4 programs of the Humphrey Field Analyzer combined for those patients on whom both measures were available.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis. A total field was calculated for each eye using the 30-2 and 60-4 conditions after applying the eligibility criteria for each component. Total field for a given eye was not calculated if either was missing. The unit of analysis was the eye.Each patient contributed 2, 1, or 0 eyes with non-missing data.|||annual change in dB vf sensitivity||Standard Error|Mean
2824825|NCT00346333|Secondary|Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target from the 30 degree meridian to the 60 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;lower sample sizes for this endpoint reflect instances where test results were not available for this outcome variable.The ability to perform this test was not a criterion for study entry.Eyes with an initial score ≥ 10 were included. Values were set to zero for all visits after an initial value of zero.|||annual change in dB vf sensitivity||Standard Error|Mean
2824826|NCT00346333|Primary|Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).|Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|Intention to treat analysis;sample of 215 patients with all 4 years of followup and reliable, non missing data at all 4 years was analyzed. Eyes with an initial 30-2 total point score >= 250 dB were included.The eye was the unit of analysis. Each patient contributed 2,1, or 0 eyes with non-missing data.|||annual change in db vf sensitivity||Standard Error|Mean
2824827|NCT00346268|Other Pre-specified|Total Amount of Postoperative Drainage Fluid|After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.|24 hours post surgery|Data not analyzed due to study termination.|||mL|||Number
2824828|NCT00346268|Other Pre-specified|Hemoglobin Concentration||24 hours post surgery|Data not analyzed due to study termination.|||g/dL|||Number
2824829|NCT00346268|Other Pre-specified|Overall Analgesic Benefit Score (OABS)|Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.|24 and 48 hours post surgery|Data not analyzed due to study termination.|||scores on a scale|||Number
2824830|NCT00346268|Other Pre-specified|Number of Participants With Health Care Resource Utilization (HCRU)|"Supervising physician or nurse answered question in the presence of participant, In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist."|24 and 48 hours post surgery|Data not analyzed due to study termination.|||participants|||Number
2824831|NCT00346268|Other Pre-specified|Number of Participants With Rating of Global Evaluation of Study Medication|"Participants asked, How would you rate the study medication you received for pain since your surgery? choices included: Poor, Fair, Good, and Excellent."|48 hours post surgery|FAS; N=participants with evaluable data.|||participants|||Number
2824832|NCT00346268|Secondary|Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score|Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.|24 and 48 hours post surgery|FAS; N=participants with evaluable data.|||scores on scale||Standard Deviation|Mean
2824833|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.|||scores on a scale||Standard Deviation|Mean
2824834|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method.|||scores on a scale||Standard Deviation|Mean
2824835|NCT00346268|Secondary|Pain Intensity Score|"Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).~Movement defined as sitting up from a lying into a sitting position in bed."|12, 24, 36, and 48 hours post surgery|FAS; N=participants with evaluable data|||scores on a scale||Standard Deviation|Mean
2824836|NCT00346268|Secondary|Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units||48 hours post surgery|FAS|||participants|||Number
2824859|NCT00346151|Secondary|Proportion of Participants With Delayed Graft Function||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2829096|NCT00308711|Secondary|Minutes to Rupture of Membranes (ROM)|Interval from study drug insertion to ROM.|2880 minutes||||minutes||95% Confidence Interval|Median
2824842|NCT00346216|Secondary|The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)|CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer|ITT Population - 30 months; MITT Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Percentage of Participants|||Number
2824843|NCT00346216|Secondary|The First Occurrence of a Major Adverse Cardiovascular Events (MACE)|MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA|ITT Population - 30 months; MITT Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Percentage of Participants|||Number
2824844|NCT00346216|Primary|The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).|APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).|Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months|"ITT - The ITT population will consist of all subjects randomized for participation in the study.~MITT - The MITT analysis population consisted of all randomized subjects who had received at least one dose of study drug, and contributed at least one post-baseline visit."|||Percentage of Partcipants|||Number
2824845|NCT00346164|Secondary|Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems|POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.|At diagnosis|Ineligible patients, as well as patients without histologic grade determined by POG or FNCLCC were excluded. The OM evaluates the degree of agreement of two pathology grading systems applied at diagnosis. The time frame “At diagnosis” reflects the OM.|||Participants|||Count of Participants
2824846|NCT00346164|Secondary|Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers|Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.|At Diagnosis|Ineligible patients, as well as patients without histologic grade determined by enrolling institution or central pathology reviewers were excluded. The OM evaluates the degree of agreement of two pathology grading reviews at diagnosis. The time frame “At diagnosis” reflects the OM.|||Participants|||Number
2824847|NCT00346164|Secondary|Genetic and Gene Expression Profiles|The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.|At diagnosis|None of the tumors were analyzed for genetic and gene expression profiles. The analysis will not be completed. The time frame “At diagnosis” is the time frame for the gene expression profiles.||||||
2824848|NCT00346164|Secondary|Incidence of Distant Metastasis|Percent of patients who had distant metastasis.|Up to 10 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Percentage of participants||95% Confidence Interval|Number
2824849|NCT00346164|Secondary|Incidence of Distant Metastasis|Percent of patients who had distant metastasis.|Up to 10 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Percentage of participants||95% Confidence Interval|Number
2824850|NCT00346164|Secondary|Overall Survival Probability Extent of Resection of the Primary Tumor|Probability of survival after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
2824851|NCT00346164|Secondary|Overall Survival Probability Disease Extent|Probability of survival after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
2824852|NCT00346164|Secondary|Event Free Survival Probability Histologic Grade|Probability of no relapse, secondary malignancy or death after 5 years since enrollment|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
2824853|NCT00346164|Secondary|Event Free Survival Probability Disease Extent|Probability of no relapse, secondary malignancy or death after 5 years since enrollment.|5 years|94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.|||Probability||95% Confidence Interval|Number
2824854|NCT00346164|Secondary|Percent Tumor Necrosis|Percent tumor necrosis by pathology review.|13 weeks|Only Arm D patients were evaluated at week 13 for percent tumor necrosis. Ineligible and inevaluable Arm D patients were excluded.|||percentage of tumor necrosis||Standard Deviation|Mean
2824855|NCT00346164|Secondary|Complete or Partial Response Rate|Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.|13 weeks|Only Arm D patients were evaluated for imaging response at week 13 after surgery. Ineligible and inevaluable Arm D patients were excluded.|||percentage of patients||95% Confidence Interval|Number
2824856|NCT00346164|Secondary|Toxicity Rate|Percentage of Arm D patients experiencing grade 4+ adverse events.|13 weeks|Excluding ineligible patients and patients not treated based on the protocol.|||percentage of participants||95% Confidence Interval|Number
2829174|NCT00308308|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population|||Number of events/subject-month|||Number
2824864|NCT00346151|Secondary|Proportion of Participants With Post-transplant Infections|Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2824865|NCT00346151|Secondary|Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection|"Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample|||Participants|||Number
2824866|NCT00346151|Secondary|Time From Transplant to Acute Rejection|"Time (days) from transplant to occurrence of acute rejection[1]~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation until rejection occurs (participants followed up to four years post-transplantation)|Intent to treat sample participants with rejection|||Days||Full Range|Median
2824867|NCT00346151|Secondary|Graft Survival at 12 Months Post-transplant||12 months post-transplant|Intent to treat sample participants not terminating prior to 12 months|||Participants|||Number
2824868|NCT00346151|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks|"GFR utilizing clearance of iothalamate.~GFR is an index of level of kidney function. A higher value means better kidney function."|24 weeks post-transplant|Intent to Treat Sample|||mL/min/1.73m^2||Standard Deviation|Mean
2824869|NCT00346151|Secondary|Tolerance Induction|Time from transplantation to initiation of sirolimus withdrawal.|48 months|Intent to treat sample that initiated sirolimus withdrawal|||Days|||Number
2824870|NCT00346151|Secondary|Acute Rejection at 12-Months|"Incidence of acute rejection[1] at 12 months post-transplant~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|12 months post-transplant|Intent to Treat Sample|||Participants|||Number
2824871|NCT00346151|Secondary|Participant Survival at 12 Months Post-Transplant||12 months post-transplant|Intent to Treat Sample participants not terminating prior to 12 months.|||Participants|||Number
2824872|NCT00346151|Primary|Acute Rejection at 6-Months|"Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|6 months post-transplant|Intent to Treat|||Participants|||Number
2824873|NCT00346073|Secondary|Number of Subjects Reporting the Onset of New Chronic Illnesses|New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.|During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.|||Participants|||Count of Participants
2824874|NCT00346073|Secondary|Number of Subjects Reporting Emergency Room Visits|Emergency room visits refer to AEs requiring immediate medical attention.|During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.|||Participants|||Count of Participants
2824875|NCT00346073|Secondary|Number of Subjects Reporting Hospitalizations|Hospitalization signified that the subject had been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out patient setting.|During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.|||Participants|||Count of Participants
2824876|NCT00346073|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. Two subjects were not contacted after the active phase of study, but had SAEs reported in the ESFU period.|||Participants|||Count of Participants
2824877|NCT00346073|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the active phase of the study (Day 0 - Day 30)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2825013|NCT00344968|Primary|Visual Acuity|The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).|36 months|Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.|||percentage of subjects|||Number
2824878|NCT00346073|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day period (Days 0-30) following vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2824879|NCT00346073|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as temperature measured orally, greater than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [gastro sympt.] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day period (Day 0-14) following vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2824880|NCT00346073|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 15-day period (Day 0-14) following vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
2824881|NCT00346073|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824882|NCT00346073|Secondary|Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)|Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 0.1 IU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥ 0.4 IU/mL), one month after vaccination; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination.|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2824883|NCT00346073|Secondary|Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies|A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to (≥) 1.0 international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2824884|NCT00346073|Primary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and < 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. The primary outcome results only refer to subjects who received a Boostrix vaccination.|||Participants|||Count of Participants
2824885|NCT00346073|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available. The primary outcome results only refer to subjects who received a Boostrix vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824886|NCT00346073|Primary|Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies|A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2825014|NCT00344773|Secondary|Safety Profile: Participants With Adverse Events|Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.|baseline to end of study|||||||
2829175|NCT00308308|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population|||Number of events/subject-month|||Number
2824887|NCT00346073|Primary|Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
2824888|NCT00346034|Primary|Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score|"Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 no pain to 100 worst possible pain. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind."|Week 12 (end of treatment)|This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.|||mm||Standard Deviation|Mean
2824889|NCT00346034|Primary|Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score|"Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 no pain to 100 worst possible pain. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind."|Week 4|This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.|||mm||Standard Deviation|Mean
2824890|NCT00345969|Secondary|Change in Serum Testosterone Level|Total Serum Testosterone Level (ng/mL)|Baseline and Six Months|Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up.|||ng/mL||Standard Deviation|Mean
2824891|NCT00345969|Other Pre-specified|Change in Serum LDL Cholesterol Level||Baseline and Six Months|Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for LDL cholesterol measurements at baseline and 6 months.|||mg/dL||Standard Deviation|Mean
2824892|NCT00345969|Other Pre-specified|Change in Serum HDL Cholesterol Level||Baseline and Six Months|Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for HDL cholesterol measurements at baseline and 6 months.|||mg/dL||Standard Deviation|Mean
2824893|NCT00345969|Other Pre-specified|Change in Serum Total Cholesterol Level||Baseline and Six Months|Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for cholesterol measurements at baseline and 6 months.|||mg/dL||Standard Deviation|Mean
2824894|NCT00345969|Other Pre-specified|Change in Hematocrit|Percentage of the volume of whole blood composed of Red Blood Cells|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided hematocrit measurements at baseline and 6-month follow-up.|||percent||Standard Deviation|Mean
2824895|NCT00345969|Other Pre-specified|Change in Serum Prostate Specific Antigen (PSA) Level||Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum PSA level measurements at baseline and 6 month follow-up.|||ng/mL||Standard Deviation|Mean
2824896|NCT00345969|Secondary|Change in Total Modified Physical Performance (mPPT) Score|The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements.|||units on a scale||Standard Deviation|Mean
2824897|NCT00345969|Secondary|Change in Femoral Bone Mineral Density (BMD)|Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 10 participants in the Exercise+Testosterone group, provided femoral bone density measurements at baseline and the 6 month follow-up.|||g/cm2||Standard Deviation|Mean
2824898|NCT00345969|Secondary|Change in Total Body Fat Mass|Total Body Fat Mass as measured by DXA|Baseline and Six Months||||kg||Standard Deviation|Mean
2824899|NCT00345969|Secondary|Change in Leg Extension Torque at 60 Deg/Sec|Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec|Baseline and Six Months|Only 10 participants in the Exercise+Placebo group, and 8 participants in the Exercise+Testosterone group, provided Leg extension torque measurements at baseline and 6 month follow-up.|||ft/lb||Standard Deviation|Mean
2824900|NCT00345969|Secondary|Change in Isokinetic Leg Extension Torque at 0 Deg/Sec|Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec|Baseline and Six Months|Only 10 participants in Exercise+Placebo group, and 8 participants in Exercise+Testosterone group, provided Leg Extension torque measurements at baseline and 6-month follow-up.|||ft/lb||Standard Deviation|Mean
2824901|NCT00345969|Primary|Change in Skeletal Muscle Strength by 1-RM|One-repetition maximum strength for leg extension|Baseline and Six Months|Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up.|||lbs.||Standard Deviation|Mean
2824902|NCT00345969|Primary|Mean Change in Total Lean Body Mass|Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)|Baseline and Six Months||||kg||Standard Deviation|Mean
2824903|NCT00345878|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
2825015|NCT00344773|Secondary|Overall Survival (OS)|Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.|baseline to 12 months||||Percent of Participants|||Number
2824904|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|"NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes, allergies,...~Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or SAEs that are not related to common diseases."|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
2824905|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days after any vaccination||||Participants|||Count of Participants
2824906|NCT00345878|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days after each vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2824907|NCT00345878|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 0 and Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824908|NCT00345878|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
2824909|NCT00345839|Secondary|Time to Parathyroidectomy|Time to Parathyroidectomy. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824910|NCT00345839|Secondary|Time to Bone Fracture|Time to Bone Fracture. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824911|NCT00345839|Secondary|Time to Stroke|Time to Stroke. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824912|NCT00345839|Secondary|Time to Cardiovascular Mortality|Time to Cardiovascular Mortality. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824913|NCT00345839|Secondary|Time to Peripheral Vascular Event|Time to Peripheral Vascular Event. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824914|NCT00345839|Secondary|Time to Heart Failure|Time to Heart Failure. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824915|NCT00345839|Secondary|Time to Hospitalization for Unstable Angina|Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824916|NCT00345839|Secondary|Time to Myocardial Infarction|Time to Myocardial Infarction. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824917|NCT00345839|Secondary|Time to All-cause Mortality|Time to All-cause Mortality. Stratified by history of diabetes and country.|From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824951|NCT00345579|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824918|NCT00345839|Primary|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.|From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.|||Months||Inter-Quartile Range|Median
2824919|NCT00345683|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824920|NCT00345683|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824921|NCT00345683|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824922|NCT00345683|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824923|NCT00345683|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824924|NCT00345683|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824925|NCT00345683|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824926|NCT00345683|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.|||Subjects|||Number
2824927|NCT00345631|Secondary|Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events|Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse|From end of vessel closure procedure to 30 days post-procedure|Intent to treat population|||Percentage of participants|||Number
2824928|NCT00345631|Secondary|Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure|Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint's closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.|From catheterization procedure to 30 day post-procedure follow up|Intent to Treat Population|||Percentage of participants|||Number
2824929|NCT00345631|Secondary|Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure|Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.|Within 5 minutes post-procedure|Intent to treat population (ITT) excluding the Manual Compression (MC) patients since MC Patients didn't deploy the device.|||Percentage of participants|||Number
2824930|NCT00345631|Secondary|Time to Device Deployment, up to 5 Minutes|Time to device deployment is defined as from the time device inserted to the time sheath removed|From device inserted to introducer sheath removal|Intent to Treat population with non-missing time data, excluding MC patients. Patients in the MC arm didn't deploy the device.|||Hour||Standard Deviation|Mean
2824931|NCT00345631|Secondary|Time to Hospital Discharge|Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge|From introducer sheath removal to patient discharge|Intent to Treat population with non-missing time data|||Hour||Standard Deviation|Mean
2824932|NCT00345631|Secondary|Time to Eligibility for Hospital Discharge|Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient's physician.|From introducer sheath removal to hospital discharge, up to 284 hours|Intent to treat population with non-missing time data|||Hour||Standard Deviation|Mean
2824952|NCT00345540|Secondary|Progression Free Survival (PFS)||From time of treatment start to time of disease progression||||Weeks||Full Range|Mean
2824953|NCT00345540|Secondary|Safety of NOV-002 and Carboplatin||Duration of trial and through 30-day follow-up period after final treatment||||Adverse Events|||Number
2824954|NCT00345540|Primary|Response Rate||At treatment completion (8 weeks) and monthly until disease progression||||Participants|||Number
2824933|NCT00345631|Primary|Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure|Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.|From post-procedure to 30 days follow up|Intent to treat population|||Percentage of participants|||Number
2824934|NCT00345631|Primary|Time to Ambulation (TTA)|Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.|From when the introducer sheath was removed to 30 days post-procedure|Intent to Treat (ITT)Population with non-missing time to ambulation data.|||Hours||Standard Deviation|Mean
2824935|NCT00345631|Primary|Time to Hemostasis (TTH)|Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.|From when the introducer sheath was removed to the time hemostasis was first observed|Intent to treat population (ITT) with non-missing time to hemostasis data. ITT population consists of all randomized (VCD and MC) patients where a femoral artery closure procedure is attempted post-randomization.|||Minutes||Standard Deviation|Mean
2824936|NCT00345605|Primary|Measures of Liver Function: INR|The result (in seconds) for a prothrombin time performed on a normal individual will vary according to the type of analytical system employed. This is due to the variations between different batches of manufacturer's tissue factor used in the reagent to perform the test. The INR was devised to standardize the results. Each manufacturer assigns an ISI value (International Sensitivity Index) for any tissue factor they manufacture. The ISI value indicates how a particular batch of tissue factor compares to an international reference tissue factor. The ISI is usually between 1.0 and 2.0. The INR is the ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the ISI value for the analytical system being used.|Measured after each 1-week treatment period||||seconds||Inter-Quartile Range|Mean
2824937|NCT00345605|Primary|Measures of Liver Function: Coagulation Factors|Plasma levels of coagulation factors I and IX were used as measures of hepatic synthetic function since the treatment duration was short.|Measured after each 1-week treatment period||||mg/dL||Standard Deviation|Mean
2824938|NCT00345605|Primary|Measures of Liver Function: PT and PTT|Prothrombin time (PT) and partial thromboplastin time (PTT) were measured PT measures factors I (fibrinogen), II (prothrombin), V, VII, and X, while PTT is a performance indicator of the efficacy of the common coagulation pathways.|Measured after each 1-week treatment period||||seconds||Inter-Quartile Range|Mean
2824939|NCT00345605|Secondary|Urea Production Rate||Measured after each 1-week treatment period||||micromoles/kg/hr||Standard Deviation|Mean
2824940|NCT00345605|Secondary|Arginine Levels||Measured after each 1-week treatment period||||micromoles/L||Inter-Quartile Range|Median
2824941|NCT00345605|Secondary|Argininosuccinic Acid Levels||Measured after each 1-week treatment period||||micromole/l||Inter-Quartile Range|Median
2824942|NCT00345605|Primary|Measures of Liver Function: AST and ALT|Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were measured.|Measured after each 1-week treatment period||||IU/L||Standard Error|Mean
2824943|NCT00345592|Primary|Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation||3 years from randomization (39 months total)||||participants|||Number
2824944|NCT00345579|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER)||From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824945|NCT00345579|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824946|NCT00345579|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824947|NCT00345579|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824948|NCT00345579|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)||From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2824949|NCT00345579|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.|||Subjects|||Number
2825016|NCT00344773|Secondary|Progression Free Survival (PFS)|Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.|baseline to 4 months||||Percent of Participants|||Number
2824955|NCT00345397|Primary|Change in Bowel QoL|"Spinal Cord Injury (SCI) -Specific, 20-Question QoL Instrument used a Visual Analog Scale (VAS) for each item.~These were scored by measurement and recording 1-10 along the scale (1 being best, 10 being worst) An average of the scores for the 20-items was calculated for each subject before and after Percutaneous Endoscopic Colostomy (PEC) Tube placement.~A Global SCI-QoL Score was also recorded using the same VAS. The difference between these Intake and Exit scores was used to define change in SCI-Specific Quality of Life."|Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement|Subjects completing both Intake and Exit assessments|||units on a scale||Standard Deviation|Mean
2824956|NCT00345384|Secondary|Measure the Amount of Respiratory Depression in Each Groups|Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.|Hours 6 to 16||||mmHg||Standard Deviation|Mean
2824957|NCT00345384|Primary|Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.|To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.|An average of 24 hours, up to 30 hours per patient|Participants completing the study were analyzed as per protocol|||IV morphine equivalency in mg||95% Confidence Interval|Number
2824958|NCT00345371|Secondary|Abstinence (Weeks 1 - 12)|Number of participants who abstained from methamphetamine from weeks 1 through 12|Weeks 1 through 12||||Participants|||Count of Participants
2824959|NCT00345371|Primary|Abstinence (Weeks 6 - 12)|The number of participants who abstained from methamphetamine from weeks 6 through 12|weeks 6 through 12||||Participants|||Count of Participants
2824960|NCT00345358|Secondary|Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination)|"Titers of antibodies are presented as geometric mean titers. Seroprotection status, defined as: Anti-polio type 1/2/3 titers >= 8. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix <6M & 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.|||Titers||95% Confidence Interval|Geometric Mean
2824961|NCT00345358|Secondary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination)|"Concentrations of antibodies are presented as geometric mean concentrations expressed as enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status, defined as: Anti-PT, anti-FHA & anti-PRN antibody concentrations >=5 EL.U/mL. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix <6M & 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824962|NCT00345358|Secondary|Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Booster Vaccination)|"Concentrations of antibodies are presented as geometric mean concentrations expressed as micrograms per milliliter (µg/mL). Seroprotection status, defined as: anti-PRP antibody concentrations >= 0.15 µg/mL and >= 1.0 µg/mL. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix <6M & 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.|||μg/mL||95% Confidence Interval|Geometric Mean
2824963|NCT00345358|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination)|"Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per milliliter (IU/mL). Seroprotection status, defined as: Anti-D & anti-T antibody concentrations >= 0.1 IU/mL.. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix <6M & 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.|||IU/mL||95% Confidence Interval|Geometric Mean
2824971|NCT00345358|Secondary|Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination)|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 3 doses (D1, D2 and D3) of the Synflorix™ vaccine co-administered with Infranrix™ in the <6 months priming group; across the 2 doses of the Synflorix™ vaccine in the 7-11 months priming group; across the 2 doses of the Synflorix™ vaccine in the 12-23 months priming group and in the 1 dose of Synflorix™ vaccine in the ≥24 months priming group.|Within 4-day (Days 0-3) following the primary vaccination|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).|||Participants|||Count of Participants
2825028|NCT00344487|Primary|Absolute Change in CD4 Cell Count From Baseline, and at 6 and 12 Months||6 and 12 months|||||||
2824964|NCT00345358|Secondary|Number of Subjects With Solicited General Symptoms (Primary Vaccination)|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 3 doses (D1, D2 and D3) of the Synflorix™ vaccine co-administered with Infranrix™ in the <6 months priming group; across the 2 doses of the Synflorix™ vaccine in the 7-11 months priming group; across the 2 doses of the Synflorix™ vaccine in the 12-23 months priming group and in the 1 dose of Synflorix™ vaccine in the ≥24 months priming group.|Within 4-day (Days 0-3) following the primary vaccination|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).|||Participants|||Count of Participants
2824965|NCT00345358|Secondary|Number of Subjects With Serious Adverse Events (SAEs). (Booster Vaccination)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the booster vaccination course|The analysis was performed on the Booster Total Vaccinated, which cohort included all subjects from the Synflorix <6M & Synflorix 7-11M groups, who received the booster dose.|||Participants|||Count of Participants
2824966|NCT00345358|Secondary|Number of Subjects With Serious Adverse Events (SAEs) (Primary Vaccination)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the Primary vaccination course up until start of Booster vaccination course|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).|||Participants|||Count of Participants
2824967|NCT00345358|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs). (Booster Vaccination)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within 31 day (Days 0-30) following the booster vaccination|The analysis was performed on the Booster Total Vaccinated, which cohort included all subjects from the Synflorix <6M & Synflorix 7-11M groups months groups, who received the booster dose.|||Participants|||Count of Participants
2824968|NCT00345358|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs). (Primary Vaccination)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within 31-day (Days 0-30) post primary vaccination|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects (e.g. all subjects who received at least one primary dose).|||Participants|||Count of Participants
2824969|NCT00345358|Secondary|Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination)|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within 4 day (Days 0-3) following the booster vacination|The analysis was performed on the Booster Total Vaccinated, which cohort included all subjects from the Synflorix <6M & Synflorix 7-11M groups months groups, who received the booster dose.|||Participants|||Count of Participants
2824970|NCT00345358|Secondary|Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination)|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within 4-day (Days 0-3) following the booster vaccination||||Participants|||Count of Participants
2824972|NCT00345358|Secondary|Booster Vaccine Response to PT, FHA and PRN|"Booster vaccine response to PT, FHA and PRN, defined as appearance of antibodies in subjects who were seronegative (S-) prior to the booster dose (i.e., with concentrations < 5 EL.U/mL), and at least two-fold increase of pre-booster vaccination antibody concentrations in those who were seropositive (S+) prior to the booster dose (i.e., with concentrations >= 5 EL.U/ mL). Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|Before and one month after the booster dose with Synflorix™|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects (from Synflorix <6M & 7-11M groups) for whom assay results were available for at least one study vaccine antigen after the booster vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, only that group was assessed for this Outcome.|||Subjects|||Number
2824973|NCT00345358|Secondary|Anti-polio Type 1, 2 and 3 Titers. (Primary Vaccination)|Titers of antibodies are presented as geometric mean titers. Seroprotection status, defined as: Anti-polio type 1/2/3 titers >= 8.|At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.|||Titers||95% Confidence Interval|Geometric Mean
2824974|NCT00345358|Secondary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Primary Vaccination)|"Concentrations of antibodies are presented as geometric mean concentrations expressed as enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status, defined as: Anti-PT, anti-FHA & anti-PRN antibody concentrations >= 5 EL.U/mL. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|At 1 month after the administration of the primary vaccination course(Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824975|NCT00345358|Secondary|Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Primary Vaccination)|"Concentrations of antibodies are presented as geometric mean concentrations expressed as micrograms per milliliter (µg/mL). Seroprotection status, defined as: anti-PRP antibody concentrations >=0.15 µg/mL and >= 1.0 µg/mL. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.|||μg/mL||95% Confidence Interval|Geometric Mean
2824976|NCT00345358|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations. (Primary Vaccination)|"Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per milliliter (IU/mL). Seroprotection status, defined as: Anti-D & anti-T antibody concentrations >=0.1 IU/mL. Since only Synflorix <6M Group had received DTPa-IPV/Hib, therefore only that group was assessed for this Outcome."|At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available for at least one study vaccine antigen component and at least one time point after primary vaccination. Only Synflorix <6M Group received DTPa-IPV/Hib, thus only that group was assessed for this Outcome.|||IU/mL||95% Confidence Interval|Geometric Mean
2824977|NCT00345358|Secondary|Antibody Concentrations Against Protein D. (Booster Vaccination)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. Seropositivity = Anti-PD antibody concentrations >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups|The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix <6M & 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824978|NCT00345358|Secondary|Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination)|OPA titers against pneumococcal serotypes 6A, 19A (Opsono-6A, 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups|The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix <6M & 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||Titers||95% Confidence Interval|Geometric Mean
2824979|NCT00345358|Secondary|Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination)|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups|The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix <6M & 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||Titers||95% Confidence Interval|Geometric Mean
2825007|NCT00345033|Primary|Change in Triglycerides||Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)|||mg/dL||Standard Deviation|Mean
2825008|NCT00345033|Primary|Change in Glucose Metabolism|A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).|||min^-1||Standard Deviation|Mean
2824980|NCT00345358|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination)|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A, 19A (ANTI-6A, -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).Seropositivity = Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 μg/mL.|Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups|The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix <6M & 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||μg/mL||95% Confidence Interval|Geometric Mean
2824981|NCT00345358|Secondary|Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination)|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per millilitre (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as Anti-pneumococcal serotypes antibody concentrations >=0.05 µg/mL.|Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups|The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix <6M & 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||μg/mL||95% Confidence Interval|Geometric Mean
2824982|NCT00345358|Secondary|Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination)|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per millilitre (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity = Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥0.05 µg/mL.|Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups|The analysis was performed on the Booster According-To-Protocol(ATP) cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available(subjects from the Synflorix <6M & 7-11M groups for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||Subjects|||Number
2824983|NCT00345358|Secondary|Antibody Concentrations Against Protein D (Anti-PD). (Primary/Full Vaccination)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. Seropositivity = Anti-PD antibody concentrations >= 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination|||EL.U/mL||95% Confidence Interval|Geometric Mean
2824984|NCT00345358|Secondary|Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination)|OPA titers against pneumococcal serotypes 6A, 19A (Opsono-6A, 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination|||Titers||95% Confidence Interval|Geometric Mean
2824985|NCT00345358|Secondary|Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination)|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. Seropositivity = Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination|||Titers||95% Confidence Interval|Geometric Mean
2824986|NCT00345358|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination)|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 6A, 19A (ANTI-6A, -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Seropositivity = Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 µg/mL.|At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination|||μg/mL||95% Confidence Interval|Geometric Mean
2824987|NCT00345358|Secondary|Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination)|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Seropositivity = Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥0.05 µg/mL.|At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination|||μg/mL||95% Confidence Interval|Geometric Mean
2824988|NCT00345358|Primary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination)|Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microg/mL.|At one month after primary (Synflorix <6M & Synflorix 7-11M Groups) or after the full (Synflorix 12-23M & Synflorix >=24M Groups) vaccination course with Synflorix™, that is Month (M)3 for Synflorix <6M & 12-23M groups, M2 for Synflorix 7-11M Group, & M1|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available.This included subjects with assay results available for antibodies against at least one study vaccine antigen component and at least one bloodsampling time point after primary vaccination|||Participants|||Count of Participants
2824989|NCT00345345|Primary|Hematological Response|The primary endpoint was haematologic response at three months after treatment. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to >500/µL, and in those with anaemia, any increase in haemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions.|3 months|The analyses included only those subjects who were given Alemtuzumab.|||Participants|||Count of Participants
2824990|NCT00345332|Secondary|Number of Incontinence Pads Used Per Day|The number of incontinence pads used per day per day was recorded by each participant in a diary.|week 13||||pads per day||Standard Error|Geometric Least Squares Mean
2824991|NCT00345332|Primary|Incontinent Episodes Per Day|The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.|week 13||||incontinence episodes per day||Standard Error|Geometric Least Squares Mean
2824992|NCT00345293|Secondary|Clinical Response||Post treatment|This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant.||||||
2824993|NCT00345293|Secondary|Immunogenicity|The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).|pre and post treatment|One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay.|||counts per minute||Full Range|Median
2824994|NCT00345293|Primary|Toxicity|adverse events|through week 29||||events|||Number
2824995|NCT00345254|Primary|Umbilical Cord pH||immediately after delivery||||pH||Standard Deviation|Mean
2824996|NCT00345176|Other Pre-specified|Genetics for the Progression of AMD and Cataract||5 years of follow-up|||||||
2824997|NCT00345176|Other Pre-specified|Genetics for the Association of AMD and Cataract||5 years of follow-up|||||||
2824998|NCT00345176|Other Pre-specified|Prevalence of Peripheral Changes as Measured Using OPTOS Imaging|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina|5 years of follow-up|||||||
2824999|NCT00345176|Other Pre-specified|Cognition as Measured by a Telephone Battery|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function|5 years of follow-up|||||||
2825000|NCT00345176|Other Pre-specified|Incident Cardiovascular Disease|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease|5 years of follow-up|||||||
2825001|NCT00345176|Secondary|Progression to Cataract Surgery|The study examined the effects of lutein/zeaxanthin on progression to cataract surgery with data collected during regular telephone contacts and the annual study visits.|5 years of follow-up|Includes participants who were phakic in at least 1 eye at baseline|||Eyes|Participants||Number
2825002|NCT00345176|Secondary|Adverse Events|Safety outcomes included serious adverse events and mortality.|5 years of follow-up|Number of deaths in 5 years|||Participants|||Number
2825003|NCT00345176|Secondary|Progression to Moderate Vision Loss|Loss defined as >/= 3 lines of letters from baseline or treatment for choroidal neovascularization|5 years of follow-up||||Eyes|Participants||Number
2825004|NCT00345176|Primary|Development of Advanced AMD in People at Moderate to High Risk for Progression.|Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.|5 years of follow-up|Intention to Treat. Participants lost to follow-up during the course of the study were censored at the time of last contact.|||Eyes|Participants||Number
2825005|NCT00345046|Primary|Percent Change in Flare at Resolution||2 months||||Percent change in flare||Standard Deviation|Mean
2825006|NCT00345033|Primary|Change in Insulin Resistance|A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)|||HOMA score||Standard Deviation|Mean
2825017|NCT00344773|Primary|Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|"Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.~RECIST criteria:~CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria"|baseline to 12 months||||Percent of Participants|||Number
2825018|NCT00344682|Secondary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6 on 10 items. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in response rate and remission rate were assessed for secondary measures.|baseline and week 8|Secondary outcome examines a change in response rates,when 50% change from baseline, & remission rates, when MADRS scores of 12 or less were observed.Fischer exact tests assessed efficiency in each treatment group. Intent-to-treat rates at baseline minus week 8 through last observed data carried forward (LOCF) were used;no data values were imputed|||units on a scale||Standard Deviation|Mean
2825019|NCT00344682|Secondary|Hamilton Anxiety Rating Scale (HARS)|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Scores > 30 indicate severe anxiety.|baseline & week 8|Secondary outcome examines a change in mean HARS scores observed at baseline & week 8 through last observed data carried forward (LOCF);no values were imputed for missing assessments.Efficacy data analysis used intent-to-treat measures & computes final study score minus baseline averaged among participants to evaluate treatment group differences|||units on a scale||Standard Deviation|Mean
2825020|NCT00344682|Secondary|Modified Quick Inventory of Depressive Symptoms Self Report Scale (QIDS-SR)|The 16 item Quick Inventory of Depressive Symptomatology (QIDS-SR16) (Rush et al. 2003) is designed to assess the severity of depressive symptoms, with higher scores representing more severe forms of depression. When complete, the QIDS are scored by summing responses to obtain a total score ranging from 0 to 27. Either appetite increase or decrease, but not both, are used to calculate the total score. Weight increase or decrease, but not both, are used to calculate the total score. Scores 0-5 indicate no severity of depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; 21-27 is very severe levels of depression. Participants were evaluated at baseline and at weeks 1, 2, 3, 4, 6 & 8.|baseline & week 8|The secondary outcome examines a change over in mean QID-SR scores at baseline & week 8 through last observed data carried forward (LOCF); no values were imputed for missing assessments. Data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.|||units on a scale||Standard Deviation|Mean
2825021|NCT00344682|Primary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in MADRS score was a primary measure.|Baseline & week 8|The primary outcome examines a mean change in MADRS scores at baseline & week 8 through last observation carried forward (LOCF); no values were imputed for missing assessments. The primary data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.|||units on a scale||Standard Deviation|Mean
2825022|NCT00344500|Primary|Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis|Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months||||Body Fat Percentage Change|||Number
2825023|NCT00344500|Primary|Change in Predicted Trajectory of Mean BMI Per GLMM Analysis|General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months||||kg/m^2|||Number
2825024|NCT00344500|Primary|Mean Weight|Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.|Weekly/Monthly, up to 1 year|All subjects who enrolled in this research program. Subjects were assessed weekly, when able. Since some were not able to do every weekly assessment, N varies weekly, and the weekly assessments below are the means of the number of subjects out of the total in the group who were assessed at that point.|||Pounds||Standard Deviation|Mean
2825025|NCT00344487|Primary|Baseline Will be Defined as the Mean of 2 Values Obtained Prior to the Medication Switch (for Analysis Purposes, the CD4 Cell Counts at 6 and 12 Months Will be Defined by the Mean of the CD4 Cell Counts Obtained at Months 3, 6 or 9, 12, Respectively).||3, 6, 0r 9, 12 months respectively|||||||
2825026|NCT00344487|Primary|Changes From Baseline in CD4 Cell Count at 6 and 12 Months||6 and 12 months|||||||
2825027|NCT00344487|Primary|Changes From Baseline in CD4 Cell Percentage at 6 and 12 Months||Baseline, 6 and 12 months||||Percentage of CD4 Cells||Standard Deviation|Mean
2825034|NCT00344461|Primary|Number of Participants With Sustained Virologic Response|The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks.|96 Weeks|HIV-1 infected Males: cluster of differentiation 4 (CD4) cell count less than 400 cells/mm3 and viral load greater than 5,000c/ml) Females: CD4 cell count less than 250 cells/mm3 and viral load greater than 5,000 c/mL at time of enrollment. Treatment naive|||Participants|||Count of Participants
2825035|NCT00344448|Primary|Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks|"Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one.~Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry.~Salivary gland biopsy:~at least 2 points improvement in the focus score on MSG biopsy~Tear flow:~at least 30% improvement in ophthalmic Oxford grading scheme or normalization of the scale as defined by score of 0 or 2mm improvement in Schirmer test as compared with the baseline in either eye."|3 months||||participant|||Number
2825036|NCT00344370|Secondary|Percent Change From Baseline in LDL-C|Percent change from baseline in LDL-C at 44 weeks|Basseline to 44 weeks||||percent change||Standard Deviation|Mean
2825037|NCT00344370|Primary|NCEP LDL-C Target Attainment|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.|44 weeks|The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment|||Participants|||Number
2825038|NCT00344318|Secondary|Number of Subjects With Vaccine Response to Bordetella Pertussis|Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations < 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825039|NCT00344318|Secondary|Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations|Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2825040|NCT00344318|Secondary|Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)|Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825041|NCT00344318|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers|Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2825042|NCT00344318|Secondary|Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8|Titers were expressed as geometric mean titres (GMTs).|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825043|NCT00344318|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2825044|NCT00344318|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)|Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825074|NCT00344305|Secondary|Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day|Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||log (TCID50)/mL||Standard Deviation|Mean
2825045|NCT00344318|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2825046|NCT00344318|Secondary|Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)|Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825047|NCT00344318|Secondary|Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations|Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2825048|NCT00344318|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825049|NCT00344318|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)|Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825050|NCT00344318|Secondary|Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)|Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825051|NCT00344318|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2825052|NCT00344318|Secondary|Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825053|NCT00344318|Secondary|Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2825054|NCT00344318|Secondary|Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)|Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825085|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 44|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.|44 Weeks||||Participants|||Number
2825055|NCT00344318|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2825056|NCT00344318|Secondary|Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825057|NCT00344318|Secondary|Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2825058|NCT00344318|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)|Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825059|NCT00344318|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)|Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2825060|NCT00344318|Secondary|Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™|The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2825061|NCT00344318|Secondary|Number of Subjects With Serious Adverse (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2825062|NCT00344318|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2825063|NCT00344318|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|Within 31 days (Days 0-30) after each vaccination|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2825064|NCT00344318|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination."|Within 4-day (Days 0-3) after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
2825065|NCT00344318|Secondary|Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|Within 4 day (Days 0-3) after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
2825066|NCT00344318|Primary|Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)|Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.|Within 4 day (Days 0-3) after each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in. For reasons of safety analysis related to rectal temperature, subjects were pooled to form the Synflorix Pooled Group and Prevenar Group.|||Participants|||Count of Participants
2825067|NCT00344305|Secondary|Number of Participants With REs in Relation to Any Vaccine Virus Shedding|REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.|Days 0-28 after study vaccination (up to Day 28)|Safety population included all participants who received any study drug and had experienced any follow-up for safety. Here, number of participants analyzed signified those participants who had REs.|||participants|||Number
2825068|NCT00344305|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism).|Days 0-180 after vaccination (up to 6.5 months)|Safety population included all participants who received any study drug and had experienced any follow-up for safety.|||participants|||Number
2825069|NCT00344305|Secondary|Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination|REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Days 0-28 after vaccination (up to Day 28)|Safety population included all participants who received any study drug and had experienced any follow-up for safety.|||participants|||Number
2825070|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||participants|||Number
2825071|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||participants|||Number
2825072|NCT00344305|Secondary|Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus|The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes. Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.|Days 1-28 after study vaccination (up to Day 28)|Shedding population: all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||participants|||Number
2825073|NCT00344305|Secondary|Quantitation of Confirmed B Shed Vaccine Virus on Any Day|Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||log (TCID50)/mL||Standard Deviation|Mean
2825075|NCT00344305|Secondary|Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day|Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||log (TCID50)/mL||Standard Deviation|Mean
2825076|NCT00344305|Secondary|Duration of Confirmed B Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed B strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
2825077|NCT00344305|Secondary|Duration of Confirmed A/H3N2 Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
2825078|NCT00344305|Secondary|Duration of Confirmed A/H1N1 Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
2825079|NCT00344305|Secondary|Duration of Any Vaccine Virus Shedding|The number of days of shedding was summarized for all participants who shed any vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.|||days||Standard Deviation|Mean
2825080|NCT00344305|Primary|Percentage of Participants Who Shed B Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2825081|NCT00344305|Primary|Percentage of Participants Who Shed A/H3N2 Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2825082|NCT00344305|Primary|Percentage of Participants Who Shed A/H1N1 Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2825083|NCT00344305|Primary|Percentage of Participants Who Shed Any Vaccine Virus|Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Days 1-28 after study vaccination (up to Day 28)|Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
2825084|NCT00344175|Secondary|Percent Change From Baseline in LDL-C||Baseline to 44 weeks||||percent change||Standard Deviation|Mean
2825086|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 16|Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.|16 weeks|All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment.|||particpants|||Number
2825087|NCT00344032|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
2825088|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|Throughout the study period (up to Month 7)||||Participants|||Count of Participants
2825089|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Days 0 - 29) after each vaccination||||Participants|||Count of Participants
2825090|NCT00344032|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days (Days 0 - 6) after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2825091|NCT00344032|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2825092|NCT00344032|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.|||Participants|||Count of Participants
2825093|NCT00344019|Secondary|Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours|||||||
2825094|NCT00344019|Secondary|Inflammatory Markers (CRP)|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours|||||||
2825095|NCT00344019|Secondary|Other Biomarkers of Myocyte Injury (CK, CK-MB)|No data was analyzed due to small numbers. Collected data no longer available as retention period has passed|24 hours|||||||
2825096|NCT00344019|Primary|Peri-procedural Myonecrosis|As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT|24 hours|Study closed due to slow recruitment and data was not analyzed. Collected data is no longer available as retention period has passed and investigator has left the institution.||||||
2825097|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|At Month 30, Month 42, Month 54 & Month 66|LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point.|||Participants|||Number
2825098|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Month 0 to Month 66)|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group.|||Subjects|||Number
2825099|NCT00343915|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) follow-up period after each vaccination and overall|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group|||Subjects|||Number
2825100|NCT00343915|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.|||Subjects|||Number
2825101|NCT00343915|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.|||Subjects|||Number
2825102|NCT00343915|Secondary|Number of Subjects Seroprotected for Anti-HBs Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Months 1, 2 and 6|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
2825103|NCT00343915|Secondary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Months 1, 2, 6 and 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||mIU/mL||95% Confidence Interval|Geometric Mean
2825104|NCT00343915|Primary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2825105|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.|||Subjects|||Number
2825106|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
2825107|NCT00343889|Secondary|Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after each vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.|||Participants|||Number
2825108|NCT00343889|Secondary|Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).~Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination."|1 month post third vaccination|Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population.|||Participants|||Number
2825109|NCT00343889|Secondary|Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.~Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.|||Participants|||Number
2825110|NCT00343889|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).|1 month post third vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2825111|NCT00343889|Primary|Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.~Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection to hepatitis H Antigen was assessed in the per-protocol population.|||Participants|||Number
2825112|NCT00343889|Secondary|Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.~Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.|||Participants|||Number
2825113|NCT00343863|Secondary|Quality of Life||Up to 3 months||||FLIE questionnaires|FLIE questionnaires||Count of Units
2825114|NCT00343863|Secondary|Severity of Nausea|Count of participants with severe nausea|Up to 3 months||||Participants|||Count of Participants
2825115|NCT00343863|Secondary|Side Effects of Antiemetic Medications Used||Up to 3 months||||Participants|||Count of Participants
2825116|NCT00343863|Secondary|Number of Doses of Rescue Medications Used||Days 1-7 of each cycle|Patients were unable to consistently complete this part of the FLIE questionnaire and thus we did not retain data from any of the participants.||||||
2825133|NCT00343564|Primary|Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.|Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).|28 days|Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations. Efficacy evaluable; any patient who received both cycles of treatment.|||mg/m2|||Number
2825134|NCT00343512|Secondary|Tumor Response as Measured by Ultrasound|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At screening, 8 weeks and at surgery (within 14-21 days)||||participants|||Number
2825135|NCT00343512|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Through 30 days after completion of treatment||||participants|||Number
2825136|NCT00343512|Primary|Number Participants to Achieve Pathologic Complete Response|whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)|3 month||||participants|||Number
2825137|NCT00343460|Secondary|Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1|Subject who were very satisfied on Day 1|0- 24 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825138|NCT00343460|Secondary|Quality of Life and the Impact of Nausea and Vomiting on Day 5|Functional Living Index|5 days|Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi)|||participants|||Number
2825139|NCT00343460|Secondary|Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses|"Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles~Complete Response is defined as no emetic episodes and no use of rescue medications"|0-120 Hours|Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles|||participants with overall CR|||Number
2825140|NCT00343460|Secondary|Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)|Maximum severity of nausea, days 1-5|0-120 Hours|Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825141|NCT00343460|Secondary|First and Overall Use of Rescue Medication||0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825142|NCT00343460|Secondary|Time to First Treatment Failure|Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration|0-120 Hours|Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population|||Proportion of subjects event free|||Number
2825143|NCT00343460|Secondary|Number of Emetic Episodes|Number of Emetic Episodes - days 1-5|Days 1-5|Cycle 1 - Modified Intent-to-Treat Population|||Number of Emetic Episodes||Standard Deviation|Mean
2825144|NCT00343460|Secondary|Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1|"TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.~TR during delayed-onset phase is defined as Complete Response with no nausea during >24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1."|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825145|NCT00343460|Secondary|Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1|Complete control is defined as complete response with no more than mild nausea.|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825146|NCT00343460|Primary|Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|24-120 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825147|NCT00343460|Primary|Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|0-24 Hours|Cycle 1 - Modified Intent-to-Treat Population|||participants|||Number
2825148|NCT00343382|Secondary|Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.|Baseline and Week 6|Includes all participants who completed both baseline and week 6 assessments.|||units on a scale||Standard Deviation|Mean
2825149|NCT00343382|Secondary|Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).|||units on a scale||Standard Deviation|Mean
2825151|NCT00343382|Primary|Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics|Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).|||units on a scale||Standard Deviation|Mean
2825152|NCT00343291|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rate)|Functional Assessment of Cancer Therapy for Patients With Lung Cancer (FACT-L) measures domains of health-related quality of life (HR-QL): physical wellbeing (WB), social/family WB, emotional WB, functional WB, and additional lung cancer concerns. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item Lung cancer subscale (LCS) score maintained for 2 consecutive assessments. Scores range from 0-28 with higher scores indicating fewer symptoms. Patients with a score of >26 were not evaluable for symptom response, since a score of 28 is the maximum possible.|From date of partial response until progression of disease up to 31.8 months|Included all enrolled, randomized participants with a score of ≤26 at baseline. All participants were analyzed as part of the treatment group to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2825153|NCT00343291|Secondary|Duration of Overall Response|The duration of response, in participants with best overall response of CR or PR, is measured from the date criteria are met for CR/PR (whichever is first recorded), until the first date that the criteria for PD is met or death. CR, PR, and PD, as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions; PD≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Time of first response to the first date of PD or death due to any cause up to 31.8 months|Included all enrolled, randomized participants with a best overall response of CR or PR (responders). All participants were analyzed as part of the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2825154|NCT00343291|Secondary|Percentage of Participants Achieving an Objective Overall Response (Overall Response Rate)|The best objective overall response rate (ORR) is the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR), as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions. ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated in that arm, multiplied by 100. Participants with no post-baseline evaluation will be considered as a non-responder.|Randomization to measured progressive disease up to 31.8 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2825155|NCT00343291|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death. Participants who are alive will be censored on the last known alive date.|Randomization to the date of death from any cause up to 42.7 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2825156|NCT00343291|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Randomization to PD or date of death from any cause up to 33.1 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2825157|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.|||units on a scale||Standard Error|Least Squares Mean
2825158|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.|||units on a scale||Standard Error|Least Squares Mean
2825159|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Baseline through 18 Months|Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.|||participants|||Number
2825160|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Baseline through 18 Months|Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.|||participants|||Number
2825161|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.|||participants|||Number
2825162|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.|||participants|||Number
2825163|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 18 Months|Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 18 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.|||participants|||Number
2825164|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 12 Months|Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 12 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.|||participants|||Number
2825165|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2825166|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2825167|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2825168|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2825196|NCT00342355|Primary|Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.|Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.|January 2004 until March 31 2008||||participants|||Number
2825197|NCT00342355|Secondary|Serious Adverse Events|Safety outcomes in four different randomly assigned regimens|January 2004 until March 31, 2008||||participant|||Number
2825169|NCT00343252|Secondary|Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 3 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2825170|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825171|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.|||participants|||Number
2825172|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825173|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825174|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825175|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825176|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825177|NCT00343252|Primary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.|||participants|||Number
2825178|NCT00343083|Secondary|Clinical Complete Response Rate of This Regimen in the Population|What is the the complete response (CR) rate at the completion of therapy.|3 months||||percentage of participants|||Number
2825179|NCT00343083|Secondary|Percentage of Participants With Grade 3 Toxicities of Cetuximab|"One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible.~Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity."|9 weeks||||percentage of participants|||Number
2825180|NCT00343083|Secondary|Pathological Response to Cetuximab|Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing|2 years||||participants|||Number
2825181|NCT00343083|Secondary|Overall Survival and Disease-free Survival||3 years (overall) 2 years disease-free||||percentage of participants|||Number
2825182|NCT00343083|Secondary|Local Regional Control at 2 Years||2 years||||percentage of participants|||Number
2825183|NCT00343083|Primary|The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.|The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.|3 months||||participants|||Number
2825184|NCT00343044|Secondary|Number or Participants With Toxicity||measured at each treatment cycle||||participants|||Number
2825185|NCT00343044|Secondary|Objective Response Rate|RECIST criteria|Response||||participants|||Number
2825186|NCT00343044|Secondary|Evaluation of Overall Survival|Overall survival was defined as the number of months after commencing study treatment to death.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|The planned enrollment of 40 participants was determined using a median PFS of 9 months (based on a median PFS of 7.2 months in a previous trial).|||months||95% Confidence Interval|Median
2825187|NCT00343044|Primary|Progression Free Survival|Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|This was determined assuming a median progression free survival of 9 months and an analysis calculating the sample size at which the narrowing of its 95% confidence interval became greater than .20 for every 2 patients added. Progression free survival and overall survival were estimated by using the Kaplan Meier method.|||months||95% Confidence Interval|Median
2825188|NCT00342628|Secondary|Antibody Responses to Hib CP|IgG anti-Hib CP was measured by ELISA in sera of 30 randomly chosen infants per group|Cord sera and infant sera at 7, 12, and 13 months|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.|||mcg/ml||Inter-Quartile Range|Geometric Mean
2825189|NCT00342628|Secondary|Antibody Responses to Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Toxin|IgG anti-diphtheria toxoid (DT), -tetanus toxoid (TT) and -pertussis toxin (PT) were measured by ELISA in sera of 30 randomly chosen infants per group.|Cord sera, and infants' sera at 7, 12 and 13 months of age|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.|||U/ml||Inter-Quartile Range|Geometric Mean
2825190|NCT00342628|Secondary|IgG Anti-Vi Levels|IgG anti-Vi was measured by ELISA and expressed as ELISA units (EU)in all sera.|cord sera, infants' sera at 7, 12 and 13 months|Only participants with available cord sera are included in the analyses|||ELISA units||Inter-Quartile Range|Geometric Mean
2825191|NCT00342628|Primary|Number of Infants With Adverse Reactions After Vaccination|Number of infants with Fever>=38.0 C, Induration>=2.5cm at DTP site, Induration>=2.5cm,Vi-rEPA/Hib-TT site, Erythema>=2.5cm, at DTP site, Erythema>=2.5cm, Vi-rEPA/Hib-TT site, Inconsolable crying<4hr, Inconsolable crying>=4hr per injection with Vi conjugate vaccine given in conjunction with DTP in infants.|at 2, 4, 6 and 12 months|The number of infants injected in each group for each injection was used to determine the rate of adverse reactions.|||participants|||Number
2825192|NCT00342563|Primary|Self-report Average Number of Cigarettes Per Day|self-report from only the smoking population for cigarettes per day|12 weeks|only smokers|||cigarettes||Standard Error|Mean
2825193|NCT00342563|Primary|Self-report Weekly Smoking Craving|Questionnaire of smoking urges (QSU). It has 32 questions that range from 1 to 7, there are 8 questions per sub-scale. The total range is 32 to 224. Each sub-scale ranges from 8- 56, with a higher score indicating higher craving.|12 weeks|Smokers only|||units on a scale||Standard Error|Mean
2825194|NCT00342563|Primary|Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|12 weeks|Scores presented are total, and then by subgroup.|||units on a scale||Standard Error|Mean
2825198|NCT00340834|Secondary|Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2825199|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Month 12 to end of study (up to approximately 3.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||T2 lesions||Standard Deviation|Mean
2825200|NCT00340834|Secondary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Month 0 to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.|||Estimated relapses per year||95% Confidence Interval|Number
2825201|NCT00340834|Secondary|Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2825202|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.|||T2 lesions||Standard Deviation|Mean
2825203|NCT00340834|Primary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Baseline to Month 12|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.|||Estimate relapses per year||95% Confidence Interval|Number
2825204|NCT00340704|Secondary|RA,Cmax|The accumulation ratio was calculated from the patients who were randomised to the low dose group and for whom both parameters at first dose and steady state dose were available. Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as: Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2825205|NCT00340704|Secondary|Vz/F,ss,W,Norm|Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2825206|NCT00340704|Secondary|CL/F,ss,W,Norm|Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
2825207|NCT00340704|Secondary|MRTpo,ss|Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||hours||Geometric Coefficient of Variation|Geometric Mean
2825208|NCT00340704|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||hours||Geometric Coefficient of Variation|Geometric Mean
2825209|NCT00340704|Secondary|λz,ss|Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||1/hours||Geometric Coefficient of Variation|Geometric Mean
2825210|NCT00340704|Secondary|AUCτ ,ss ,DW ,Norm|Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng*h/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
2825211|NCT00340704|Secondary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2825212|NCT00340704|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||hours||Full Range|Median
2825213|NCT00340704|Secondary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2825214|NCT00340704|Secondary|Cmax,ss, DW, Norm|Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
2825215|NCT00340704|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2825216|NCT00340704|Secondary|Cpre,ss|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS): This set includes subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2825217|NCT00340704|Secondary|Cmax, 1 ,DW ,Norm|Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)|||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
2825218|NCT00340704|Secondary|Tmax, 1|Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)|||hours||Full Range|Median
2825219|NCT00340704|Secondary|Cmax,1|Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD): This set includes subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK at Visit 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2825220|NCT00340704|Secondary|Vision Testing for Group D-527.51 Rollover|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 52|Treated Set (TS)|||Participants|||Number
2825276|NCT00339040|Secondary|CD4 Count Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4 counts at the respective time point.|||cells/µL||95% Confidence Interval|Mean
2825221|NCT00340704|Secondary|Vision Testing for Group D-Denovo|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided.|Baseline, Week 26 and Week 52.|Treated Set (TS)|||Participants|||Number
2825222|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 450 days|Treated Set (TS)|||Participants|||Number
2825223|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 395 days|Treated Set (TS)|||Participants|||Number
2825224|NCT00340704|Secondary|LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover|Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Week 1 to Week 52 (described study wise in the Description).|Full analysis set (FAS-LPP)|||participants|||Number
2825225|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 Rollover. Hydronephrosis response is defined as an improvement or stabilization based upon ultrasound grading at the end of the study. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL). This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|||Participants|||Number
2825226|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in the Group D-527.51 Rollover. Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at end of treatment compared to baseline. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL): Includes all patients in the Treated set who received one dose of treatment and had one on treatment renal measurement.|||Participants|||Number
2825227|NCT00340704|Secondary|Percent Change From Baseline in LPP for Group D-527.51 Rollover|Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 1|Full analysis set (FAS-LPP)|||percent change||Standard Deviation|Median
2825274|NCT00339040|Secondary|HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing HIV-1 viral load at the respective time point.|||Log10 (copies/mL)||95% Confidence Interval|Log Mean
2825228|NCT00340704|Secondary|Change From Baseline in LPP for Group D-527.51 Rollover|Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and week 1|Full analysis set (FAS-LPP)|||cm H2O||Standard Deviation|Median
2825229|NCT00340704|Secondary|Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover|Early responders who maintained their detrusor leak point pressure (LPP) below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2,3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was not analysed for Group D-527.51 Rollover as very limited data were collected due to early termination of the study & no alternative endpoint was defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided.|Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).|Full analysis set (FAS-LPP)|||Participants|||Number
2825230|NCT00340704|Primary|Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.|Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.|Full analysis set (FAS-LPP)|||Participants|||Number
2825231|NCT00340704|Primary|Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover|Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure <40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.|Full analysis set (FAS-LPP): This subject set includes all subjects in the Treated set who received one dose of treatment and had one on treatment LPP measurement.|||percentage of responders|||Number
2825232|NCT00340678|Secondary|Glomerular Volume||6 years after first treatment|Intention-to-treat|||*10^6 cubic microns||Standard Deviation|Mean
2825233|NCT00340678|Primary|Number of Participants With Decline in GFR|Participants were monitored for up to 6 years. This is the number of participants who had a decline in GFR to less than or equal to 60 ml/min or to half the baseline value in subjects that enter the study with a GFR of less than 120 ml/min during the time of observation.|Up to 6 years|Intention-to-treat|||participants|||Number
2825234|NCT00340379|Primary|Brief Psychiatric Rating Scale at 12 Weeks|A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.|12 weeks||||units on a Psychiatric Rating scale||Standard Deviation|Mean
2825235|NCT00340379|Primary|Clinical Global Impression Improvement Scale|A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).|12 weeks||||units on a Clinical Impressions Scale||Standard Deviation|Mean
2825236|NCT00340379|Primary|21 Item Hamilton Depression Rating Scale|The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).|12 week|Number of participants was ITT and imputed by LOCF|||Units on Hamilton Depression Scale||Standard Deviation|Mean
2825237|NCT00339833|Primary|Change in the Average Serum Insulin Concentration During the Last 40 Min of Clamp||last 40 min of clamp||||l/min||Standard Deviation|Mean
2825238|NCT00339833|Primary|Change in Fasting Plasma Glucose Concentration||7 days||||mmol/l||Standard Deviation|Mean
2825249|NCT00339144|Secondary|Mean Urine Concentration of Deoxypyridinoline (Dpyr) Biological Marker|Urine levels of DPyr is a measure of bone resorption. A decrease in Dpyr relative to the baseline indicates decrease in bone metabolism. Mean urine concentration of Dpyr biological marker was determined using ELISA.|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6 12 and 24 hours post dose on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||nanomol (nmol)/mL||Standard Deviation|Mean
2825239|NCT00339183|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.|Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.|||participants|||Number
2825240|NCT00339183|Secondary|Duration of Response|"Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Central Tumor Response Analysis Set: Responders|||months||95% Confidence Interval|Median
2825241|NCT00339183|Secondary|Time to Disease Progression|"Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
2825242|NCT00339183|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.|KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.|||percentage of participants||95% Confidence Interval|Number
2825243|NCT00339183|Primary|Overall Survival|Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
2825244|NCT00339183|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)|||months||95% Confidence Interval|Median
2825245|NCT00339144|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Within 4 weeks of first study drug administration, thereafter recorded every 4 or 8 weeks.|All treated participants with measurable disease at baseline and received at least one dose of the study drug (efficacy population).|||participants|||Number
2825246|NCT00339144|Secondary|Number of Participants With Sarcoma (Src) and Phosphorylated Src (pSRc) Protein Expression in Peripheral Blood Mononuclear Cells (PBMC)|Src and pSrc protein expression was planned to be evaluated in PBMC for establishing PK/PD relationship between Src/pSrc protein expression in PBMC and exposure of BMS-354825.|Plasma samples were collected on baseline (Day -1), 0 hour (pre-dose), 1 and 4 hours (post-dose) on Days 1, 14 and 28|All treated participants with adequate pharmacodynamic profiles. Participants could not be evaluated as the test was discontinued due to difficulty in appropriate measurements.|||participants|||Number
2825247|NCT00339144|Secondary|Mean Serum Concentration of Bone Alkaline Phosphatase (BAP) Biological Marker|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism. Serum BAP was quantified with ELISA.|Serum samples were assessed on baseline (Day -1), and pre-dose on Days 14, 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||U/L||Standard Deviation|Mean
2825248|NCT00339144|Secondary|Mean Serum Concentration of Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP-5b) Biological Marker|TRACP-5b is a measure of bone metabolism. A decrease in TRACP-5b relative to the baseline indicates decrease in bone metabolism. Serum TRACP-5b was quantified with enzyme-linked-immunosorbent serologic assay (ELISA).|Serum samples were assessed at baseline (Day -1) and on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||U/L||Standard Deviation|Mean
2825250|NCT00339144|Secondary|Mean Urine Concentration of Urinary N-telopeptide Type 1 Collagen (NTx) Biological Marker|Urine NTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism. Mean urine concentration of NTx biological marker was determined using enzyme linked immuno-sorbent assay (ELISA).|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28.|All treated participants with adequate pharmacodynamic (PD) profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||nmol*bone collagen equivalent (BCE)/mmol||Standard Deviation|Mean
2825251|NCT00339144|Secondary|Tmax of the Metabolite BMS-582691|Tmax of the metabolite was obtained using plasma concentration versus time data of metabolite BMS-582691.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||hours||Full Range|Median
2825252|NCT00339144|Secondary|AUC (0-t) of Metabolite BMS-582691|AUC (0-t) was calculated using plasma concentration values of metabolite at time 0 to the time of the last measurable concentration (t).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ng*hr/mL||Full Range|Geometric Mean
2825253|NCT00339144|Secondary|Cmax of Metabolite BMS-582691|Maximum plasma concentration was obtained from plasma concentration versus time data of metabolite (BMS-582691).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ng/ml||Full Range|Geometric Mean
2825254|NCT00339144|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib|Apparent volume of distribution after oral dosing was obtained from plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||L||Full Range|Geometric Mean
2825255|NCT00339144|Secondary|Mean Apparent Oral Clearance (CLo) of Dasatinib|Apparent oral clearance was obtained from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||L/hour||Full Range|Geometric Mean
2825256|NCT00339144|Secondary|Accumulation Index (AI) of Dasatinib|AI of Dasatinib was calculated as ratio of geometric mean of AUC(TAU) (area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration) on Day 14 or Day 28 on Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ratio||Full Range|Geometric Mean
2825257|NCT00339144|Secondary|Terminal Elimination Half-life (T-half) of Dasatinib|T-half of dasatinib was calculated using plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||hours||Standard Deviation|Mean
2825258|NCT00339144|Secondary|Time to Reach Maximum Observed Plasma Concentration of Dasatinib (Tmax)|Tmax, time to reach maximum observed plasma concentration of dasatinib was obtained directly from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||hours||Full Range|Median
2825259|NCT00339144|Secondary|AUC[TAU] of Dasatinib|Area under the plasma concentration-time curve within the dosing interval was determined. AUC(TAU), from time 0 to the time of the last measurable concentration (24 hours) was calculated for Day 1, 14, 28 respectively.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ng*hours/ml||Full Range|Geometric Mean
2825260|NCT00339144|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of Dasatinib on Day 1|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Day 1|All treated participants with adequate PK profiles (PK population).|||ng*hours/ml||Full Range|Geometric Mean
2825261|NCT00339144|Secondary|Maximum Plasma Concentration (Cmax) of Dasatinib|Cmax was obtained from the plasma concentration versus time data after oral administration of dasatinib.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate pharmacokinetic (PK)profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||nanograms (ng)/ml||Full Range|Geometric Mean
2825262|NCT00339144|Secondary|Number of Participants With Clinically Significant Change in QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial ECGs.|Baseline, Day 1, Day 14 and Day 28|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
2825275|NCT00339040|Secondary|CD4 Percent Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4%.|||percentage of total lymphocytes||95% Confidence Interval|Mean
2825263|NCT00339144|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Standard 12-lead ECG was used to record selected ECG parameters like RR interval (the time between the two R waves in ECG), PR interval (interval measured from the beginning of the P wave to the beginning of the QRS complex; QRS complex is the name for some of the deflections seen on a typical ECG)), QRS duration, QT interval (time between onset of ventricular depolarization and end of ventricular repolarization), QT interval corrected for heart rate using Bazett's (QTcB) and Fridericia's (QTcF) formulas.|From screening Day -1, and at pre-dose, 1 and 4 hours (post-dose) on Days 1, 14 and 28 in first treatment course, at pre-dose, 1 and 4 hours (post-dose) during the second and fourth week in subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
2825264|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Vital Signs|Vital signs measurements (including blood pressure, body temperature and pulse rate) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs were clinically significant.|From screening, Day 1 , 8, 15 and 22 in the 1st treatment course, Day 8 and 22 in the second and subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
2825265|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Physical Examination Measures|Interim and final physical examinations were performed. The investigator used his/her clinical judgment to decide whether or not physical examination findings were clinically significant.|From screening, Day 1 in each treatment course and at the end of study|All participants who received at least one dose of the study drug (safety population). Analysis for significant physical examination findings was not done.|||participants|||Number
2825266|NCT00339144|Secondary|Most Frequent Serum Chemistry Laboratory Abnormalities Occurring in >=10% Participants: High Magnesium|Abnormalities were graded according to the NCI-CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent (>=10%) serum laboratory abnormalities were recorded. The following definitions specify the NCI-CTC AE criteria for serum laboratory abnormalities in the data presented: magnesium: Grade 3: >3.0 - 8.0 mg/dL or >1.23 - 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
2825267|NCT00339144|Secondary|Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=10% Participants: Low Lymphocyte Count|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent hematology Grade 3 and 4 abnormalities occurring in >=10% participants were recorded. Grade 3 and 4 criteria are as follows: lymphocyte count: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All treated participants who received at least one dose of the study drug.|||participants|||Number
2825268|NCT00339144|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; magnesium: Grade 3: >3.0 - 8.0 mg/dL or >1.23 - 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L; albumin: Grade 3: <2 g/dL or <20 g/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.|||participants|||Number
2825269|NCT00339144|Secondary|Number of Participants With Grade 3 or 4 Hematology Abnormalities|Hematology abnormalities were graded per the National Cancer Institute (NCI) Common. Terminology Criteria (CTC) version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L; lymphocytes: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.|||participants|||Number
2825270|NCT00339144|Secondary|Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs (SAEs), Drug Related AEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs: events with a relationship to the study therapy of certain; probable; possible; not likely or unrelated.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).|||participants|||Number
2825271|NCT00339144|Primary|Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment|MAD: highest dose level at which >=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade >=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia <500 cells/mm^3 for >=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia <25,000 cells/mm^3 or Grade 3 bleeding requiring platelet transfusion.|From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)|All treated participants who received at least one dose of the study drug and were evaluable for DLT.|||participants|||Number
2825272|NCT00339079|Secondary|Columbia Heightened Illness Concern - Obsessive-Compulsive Scale|The Columbia Heightened Illness Concern - Obsessive-Compulsive Scale was the name for an earlier version of the H-YBOCS-M. The H-YBOCS-M is an expanded version and has additional items not included in the Columbia Heightened Illness Concern OCS. We did not administer the CHIC-OCS to patients in this study.|Not measured|||||||
2825273|NCT00339079|Primary|25% Improvement on Both Whiteley Index and H-YBOCS-M|Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis|Measured at Week 24||||Participants|||Count of Participants
2825277|NCT00339040|Primary|Serum Anti-HPV Antibody Titers (cLIA)|Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)|Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline as well as any participants with any missing values at any time points.|||milli-Merck units [mMU]/mL||95% Confidence Interval|Geometric Mean
2825278|NCT00339040|Primary|Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion|Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.|At week 28 after beginning the vaccination series|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.|||percent of participants||95% Confidence Interval|Number
2825279|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, Treatment related, Non-treatment related, Baseline, Possibly treatment related."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis|||percent of participants||95% Confidence Interval|Number
2825280|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. All grade 3 and higher signs, symptoms, and laboratory toxicities were included."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis.|||percent of participants||95% Confidence Interval|Number
2825281|NCT00338988|Primary|Number of Participants With Objective Response|Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline with restaging every 3 cycles (cycle=21 days)|Analysis was per protocol. One participant was found ineligible and received no treatment.|||participants|||Number
2825282|NCT00338962|Primary|Mean Number of Side Effects|Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.|12 weeks||||side effects||Standard Error|Mean
2825283|NCT00338962|Primary|Hamilton Depression Rating Scale (HAM-D)|The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression)|beginning of treatment (week 1), and end of treatment (13 weeks)||||units on a scale||Standard Error|Mean
2825284|NCT00338962|Primary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to:~Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD"|beginning of treatment (week 1), and end of treatment (13 weeks)||||units on a scale||Standard Error|Mean
2825285|NCT00338962|Primary|Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|beginning of treatment (week 1), and end of treatment (13 weeks)||||units on a scale||Standard Error|Mean
2825286|NCT00338884|Secondary|Cancer Related Symptoms, Well-Being, and Concerns|FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.|||scores on a scale||Standard Deviation|Mean
2825287|NCT00338884|Secondary|Patient-Assessed Fatigue|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.|||scores on a scale||Standard Deviation|Mean
2825288|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
2825289|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
2825290|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.|||ratio||Standard Deviation|Mean
2825291|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
2825292|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
2825293|NCT00338884|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.|||pg/mL||Standard Deviation|Mean
2825294|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
2825295|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.|||ratio||Full Range|Median
2825296|NCT00338884|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.|||ratio||Standard Deviation|Mean
2825297|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
2825298|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL||Full Range|Median
2825299|NCT00338884|Secondary|Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.|||picograms (pg)/mL||Standard Deviation|Mean
2825300|NCT00338884|Secondary|Ctrough Correlated With Serious Adverse Events (SAEs)|Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.||||||
2825301|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
2825302|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
2825303|NCT00338884|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.|||ng/mL||Standard Deviation|Mean
2825304|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
2825305|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
2825306|NCT00338884|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.|||ng/mL||Standard Deviation|Mean
2825307|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
2825308|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.|||ng/mL||Full Range|Median
2825309|NCT00338884|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2825310|NCT00338884|Secondary|1-Year Survival|One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year|Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.|||percent chance of survival||95% Confidence Interval|Median
2825311|NCT00338884|Secondary|Progression-Free Survival (PFS)|Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death|Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.|||months||95% Confidence Interval|Median
2825312|NCT00338884|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.|||months||95% Confidence Interval|Median
2825313|NCT00338884|Secondary|Duration of Response (DR)|Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause|Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.|||months||95% Confidence Interval|Mean
2825314|NCT00338884|Primary|Number of Subjects With Overall Confirmed Objective Response (OR)|OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.|||participants|||Number
2825315|NCT00338806|Secondary|Treatment Credibility Scale|Treatment Credibility Questionnaire. Participant and parent's expectancy about the perceived benefit of treatment will be assessed following the first intervention session after the treatment rationale is given. Adolescents were asked to rate how logical the treatment seemed to them, how confident they were that it would be successful, and how confident they would be in recommending the treatment to a friend. A 0- to 2-point rating scale (0 = none, 1 = some, 2 = a lot) was used (range of possible overall score 0-6, higher score indicating higher treatment credibility)|Measured at Week 1|An ECM participant did not fill out her form|||units on a scale||Standard Deviation|Mean
2825329|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|6 months||||units on a scale||Standard Deviation|Mean
2825316|NCT00338806|Secondary|Social Rhythm Metric Short Form|The Social Rhythm Metric Short Form (SRM-Short Form) measures habitual time at which 5 daily events occur in a person's life over a one-week interval: what time the adolescent gets out of bed, makes first contact with another person, starts school, has dinner, and goes to bed.|Measured at Week 12 and Months 6, 12, and 18 post-treatment|Participants were not filling out form (it required documentation during the week) and reconstructing it in the meetings with the clinician proved to be too time consuming. Measure was withdrawn from the assessment battery||||||
2825317|NCT00338806|Secondary|Social Adjustment Scale - Self Report for Adolescents|(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.|12 months and 18 months|At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)||||||
2825318|NCT00338806|Secondary|Social Adjustment Scale - Self Report for Adolescents|(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.|Measured at Week 12||||units on a scale||Standard Deviation|Mean
2825319|NCT00338806|Secondary|Patient Health Questionnaire|"The PHQ-9 is a depression screen, administered to the adolescents parents in this study. The PHQ-9 scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). Scores can range from 0-27, with higher score indicating higher depression levels."|Measured at Week 1||||units on a scale||Standard Deviation|Mean
2825320|NCT00338806|Secondary|Mood Disorder Questionnaire|A self-report inventory for the participant' parent that screens for history of a manic or hypomanic syndrome by including 13 yes/no items. A score >7 indicate possible history of mania/hypomania (coded as 1), <7 indicates potential absence of mania/hypomania (coded as 0)|Week 1|This measure reflects parental mood.expressed as number of participants whose parent with BDI or BDII endorsed > 7(1)|||participants|||Number
2825321|NCT00338806|Secondary|Family History Screen|A clinician-administered instrument to the adolescent' parent, designed to screen for mood, anxiety, and other disorders in parent's first-degree relatives (parents, spouse).|Measured at Week 1 (baseline)||||participants|||Number
2825322|NCT00338806|Secondary|Family Assessment Device|The General Functioning scale, that assesses the overall health/pathology of the family, is used for the study. The 12 item scores are averaged to calculate the total score, which ranges from 1-4, with higher scores reflecting worse functioning|Measured at Week 12||||units on a scale||Standard Deviation|Mean
2825323|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).~Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|12 months and 18 months|At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)||||||
2825324|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self-report10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).~Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|6 months||||units on a scale||Standard Deviation|Mean
2825325|NCT00338806|Secondary|Emotion Regulation Questionnaire|"A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).~Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression)."|Measured at Week 12|Data were not collected for 6 and 12 month time points|||units on a scale||Standard Deviation|Mean
2825326|NCT00338806|Secondary|Attitudes Toward Treatment Questionnaire|A 4 item measure to evaluate attitudes towards: length of treatment, helpfulness of therapist, effects of participating in research, and additional services desired. Each item had 3 response options: 1.positive (or longer treatment) 2.neutral (or length just right) 3. negative (or shorter treatment). Scores are summed with potential range from 4-12. Lower number indicates more positive attitude|Measured at Week 12||||units on a scale||Standard Deviation|Mean
2825327|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|18 months|At the 18 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
2825328|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|12 months|At the 12 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
2825486|NCT00336973|Primary|Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)|||percentage|||Number
2825330|NCT00338806|Primary|Young Mania Rating Scale (YMRS)|An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
2825331|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|18 months|At the 18 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
2825332|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|12 months|At the 12 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
2825333|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|6 months||||units on a scale||Standard Deviation|Mean
2825334|NCT00338806|Primary|Children's Global Assessment Scale (C-GAS)|C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.|Week 12||||units on a scale||Standard Deviation|Mean
2825335|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|18 months|At the 18 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
2825336|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|12 months|At the 12 month time point 1 participant was available /willing to be assessed|||units on a scale||Standard Deviation|Mean
2825337|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|6 months||||units on a scale||Standard Deviation|Mean
2825338|NCT00338806|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.|Week 12||||units on a scale||Standard Deviation|Mean
2825339|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|18 months|At the 18 month follow up point only 1 participant was available and willing be assessed.|||participants|||Number
2825340|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|12 months|At the 12 month follow up timepoint only 1 participant was available and willing to be assessed.|||participants|||Number
2825341|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|6 months||||participants|||Number
2825342|NCT00338806|Primary|K SADS-Present Version (KSADS-P)|A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.|12 weeks||||participants|||Number
2825343|NCT00338741|Secondary|Fetal Death/Stillbirth|Fetal death/stillbirth|Up to 10 months||||Participants|||Number
2825344|NCT00338741|Primary|Spontaneous Abortion|Number of participants having spontaneous abortion|Up to 9 months|Population includes all subjects for whom data is available|||Participants|||Number
2825345|NCT00338728|Primary|Overall Survival of Participants|This sample size would provide an estimate of the objective response rate (ORR) 95% confidence intervals for the ORR and CBR were calculated using the exact binomial method. Among patients with CR or PR as the best overall response, duration of response (DOR) was defined as the time from which measurement criteria were met for CR or PR until the date of progression. Progression-free survival (PFS) was defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. PFS data were censored at the time of removal from study. Overall survival (OS) was defined as the time from study registration to death from any cause. Information on vital status was collected following study completion through July 23, 2018 and was used in the determination of OS. Among patients with SD as the best overall response, duration of SD was defined as the time from study enrollment to disease progression or removal from study.|From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months||||months||95% Confidence Interval|Median
2825390|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure|Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5- visit 9) visits.|||mm Hg||Standard Deviation|Mean
2825346|NCT00338728|Primary|Objective Response Rate (ORR)|Among participants with CR or PR as the best overall response, duration of response (DOR) was defined as the time from which measurement criteria were met for CR or PR until the date of progression. Progression-free survival (PFS) was defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. PFS data were censored at the time of removal from study. Overall survival (OS) was defined as the time from study registration to death from any cause. Information on vital status was collected following study completion through July 23, 2018 and was used in the determination of OS. Among patients with SD as the best overall response, duration of SD was defined as the time from study enrollment to disease progression or removal from study.|From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months|Five participants was non evaluable due participants did not complete the first 2 cycles. (8 weeks)|||Participants|||Count of Participants
2825347|NCT00338598|Secondary|Baseline and End of Treatment Neurophysiological Measures||12 weeks|Data was not collected||||||
2825348|NCT00338598|Secondary|Baseline and End of Treatment Quality of Life||12 weeks|Data was not collected||||||
2825349|NCT00338598|Secondary|Weekly Drug Use||12 weeks|Data was not collected||||||
2825350|NCT00338598|Primary|Baseline and End of Treatment Cognitive Functioning Measures (Hopkins)|Hopkins Verbal Learning Test Assesses short term verbal learning and memory. Subscales include immediate recall (0-36), delayed recall (0-12) , and recognition (0-12). A higher score indicates better memory performance.|12 weeks||||units on a scale||Standard Error|Mean
2825351|NCT00338598|Primary|Weekly Ratings of Negative/Positive Psychotic Symptoms|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms for each scale.|12 weeks||||units on a scale||Standard Error|Mean
2825352|NCT00338598|Primary|Self Reported Weekly Alcohol Craving|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|12 weeks||||units on a scale||Standard Error|Mean
2825353|NCT00338598|Primary|Self Reported Weekly Alcohol Consumption|Percentage of drinking days and heavy drinking days using timeline follow back|12 weeks||||percentage of days||Standard Error|Mean
2825354|NCT00338455|Secondary|Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
2825355|NCT00338455|Secondary|All Cause Mortality||Day 30 and Months 2 and 6|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
2825356|NCT00338455|Secondary|Changes in Pulmonary Capillary Wedge Pressure (PCWP)||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
2825357|NCT00338455|Primary|Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment)|Number of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (termination of treatment or early discontinuation of treatment, whichever occurred first). The endpoint was not normalized for time on study.|28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.||||||
2825358|NCT00338286|Secondary|Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)|Suspected TVEs were identified by investigators and relevant clinical information was collected.|up to 8.4 years|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Percentage of participants|||Number
2825359|NCT00338286|Secondary|Overall Response Rate (ORR)|Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.|every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Percentage of participants|||Number
2825360|NCT00338286|Secondary|Time to Tumor Progression|The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).|From date of randomization to the date of the first documented PD (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Months||95% Confidence Interval|Median
2825361|NCT00338286|Secondary|Overall Survival|Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the final database lock, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the final database lock, OS was censored at the date of final database lock.|From randomization up to death from any cause (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Months||95% Confidence Interval|Median
2825362|NCT00338286|Primary|Progression Free Survival|Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.|From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.|||Months||95% Confidence Interval|Median
2825363|NCT00338104|Secondary|Percentage of Glucose Levels > 180 mg/dL|Percentage of blood glucose levels > 180 mg/dL|First 24 hours after conversion||||percentage of blood glucose values|||Number
2825364|NCT00338104|Secondary|Percentage of Glucose Values < 50 mg/dL|Percentage of blood glucose values < 50 mg/dL|First 24 hours after conversion||||percentage of blood glucose values|||Number
2825365|NCT00338104|Primary|Percentage of Blood Glucose Values Between 80 - 140|Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL|First 24 hours after conversion||||percentage of blood glucose values|||Number
2825366|NCT00338039|Primary|Median Overall Survival|Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.|Baseline to disease progression or death, up to 4 years||||Months||95% Confidence Interval|Median
2825367|NCT00338039|Primary|Overall Survival Rate|1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.|1 to 4 years||||percentage of participants|||Number
2825368|NCT00337987|Primary|Number of Patients That Achieved a Complete Response (CR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years||||participants|||Number
2825369|NCT00337987|Primary|Number of Patients That Achieved a Complete Response or a Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years||||participants|||Number
2825370|NCT00337935|Secondary|Time to Hemoglobin Response|Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.|||Days||95% Confidence Interval|Median
2825371|NCT00337935|Secondary|The Number of Patients Achieved a Hemoglobin Response.|Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.|||participants|||Number
2825372|NCT00337935|Primary|Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)||Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.|||g/dL||Standard Deviation|Mean
2825373|NCT00337818|Secondary|Number of Subjects Reporting SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort of each time point.|||Subjects|||Number
2825374|NCT00337818|Secondary|Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.|||Subjects|||Number
2825375|NCT00337818|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 24, 36 and 48|Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2825376|NCT00337818|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At months 24, 36, and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2825377|NCT00337818|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).~*Data for Month 18 outcome variables were incorporated into the Month 24 analyses."|At months 18*, 24, 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2825378|NCT00337779|Secondary|The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).|"The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an offset variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates."|12 months|Frequent MRI cohort|||T1 Enhancing Lesions||Standard Deviation|Log Mean
2825379|NCT00337779|Secondary|The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.|The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.|12 months||||T2 Lesions||Standard Deviation|Mean
2825380|NCT00337779|Primary|The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).|A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.|12 months|ITT|||Number of relapses per patient||Standard Deviation|Mean
2825381|NCT00337727|Secondary|Number of Patients Who Reported Complete Response|The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.|Overall phase (0-120 hours post initiation of MEC) in Cycle 1|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received MEC, (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.|||Participants|||Number
2825382|NCT00337727|Primary|Number of Patients Who Reported No Vomiting|"The number of patients who reported No Vomiting in the overall phase in Cycle~1"|Overall phase (0-120 hours post initiation of MEC) in Cycle 1.|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderately Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.|||Participants|||Number
2825383|NCT00337675|Secondary|Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes|Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.|1 Year|Patients with at least one episode culminating in an attack were included; therefore, 1120 patients were included in the analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2825384|NCT00337675|Secondary|Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode|Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.|1 Year|Only patients who experienced an asthma attack within an episode and did not start their intermittent study medication on the day of the attack could be included. Therefore, a total of 452 patients were included in this analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2825385|NCT00337675|Primary|Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period|The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.|1-year treatment period|Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population.|||Asthma attacks within episodes per year||95% Confidence Interval|Mean
2825386|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight|Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||kilograms||Standard Deviation|Mean
2825387|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure|Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||mm Hg||Standard Deviation|Mean
2825388|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate|Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||beats per minute||Standard Deviation|Mean
2825389|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure|Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||mm Hg||Standard Deviation|Mean
2825471|NCT00337168|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle|Eligible patients who started therapy|||Participants with a given type of AE|||Number
2825391|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate|Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||beats per minute||Standard Deviation|Mean
2825392|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score|A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||units on a scale||Standard Deviation|Mean
2825393|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score|Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||units on a scale||Standard Deviation|Mean
2825394|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale|Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||units on a scale||Standard Deviation|Mean
2825395|NCT00337662|Secondary|Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants|Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.|Week 2 to Week 12|Total number of patients with the lab test at baseline and post-baseline.|||participants|||Number
2825396|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||kilogram per square meter||Standard Deviation|Mean
2825397|NCT00337662|Secondary|Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups|Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
2825398|NCT00337662|Secondary|Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
2825399|NCT00337662|Secondary|Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
2825400|NCT00337662|Secondary|The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
2825401|NCT00337662|Secondary|The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.|||participants|||Number
2825428|NCT00337467|Secondary|Percentage of Participants With Treatment Failure Through Week 96|Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.|||percentage of participants|||Number
2825402|NCT00337662|Secondary|Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).|Weeks 2, 3, 4, 6, 8, 12|Intention to treat patients with both baseline and postbaseline assessment|||units on a scale||Standard Error|Least Squares Mean
2825403|NCT00337662|Primary|Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).|Weeks 0, 3, 4, 6, 8, 12|Intention to treat for patients with both baseline and any postbaseline assessment|||units on a scale||Standard Error|Least Squares Mean
2825404|NCT00337610|Secondary|Change From Baseline in A1C at Week 30|A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.|Baseline and Week 30|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.|||Percent||95% Confidence Interval|Least Squares Mean
2825405|NCT00337610|Secondary|Change From Baseline in 2 Hr-PMG at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2825406|NCT00337610|Secondary|Change From Baseline in FPG at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2825407|NCT00337610|Primary|Change From Baseline in A1C at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward (LOCF) method.|||Percent||95% Confidence Interval|Least Squares Mean
2825408|NCT00337571|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF.|||kilograms||Standard Error|Mean
2825409|NCT00337571|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuously throughout the study|Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent.|||participants|||Number
2825410|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825411|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825412|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825413|NCT00337571|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||Participants|||Number
2825472|NCT00337168|Secondary|Number of Patients With Very Poor Risk Cytogenetics||On average, 2 weeks before treatment started|Eligible patients with acceptable centrally reviewed cytogenetics|||participants|||Number
2825414|NCT00337571|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825415|NCT00337571|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825416|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 96|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.|||participants|||Number
2825417|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 48|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.|||participants|||Number
2825418|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 96|n=number of treated participants with baseline measure and measure at Week 96|||percent change||Standard Deviation|Mean
2825419|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 48|n= number of treated participants with baseline measure and measure at Week 48|||percent change||Standard Deviation|Mean
2825420|NCT00337467|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).|From Baseline through Week 96|Treated Participants|||percentage of participants|||Number
2825421|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|n=number of participants with CD4 cell count at baseline and at Week 96.|||cells /mm3||Standard Deviation|Mean
2825422|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|n=number of participants with CD4 cell count at baseline and at Week 48.|||cells /mm3||Standard Deviation|Mean
2825423|NCT00337467|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24||Baseline, Week 24|n=number of participants with CD4 cell count at baseline and at Week 24|||cells /mm3||Standard Deviation|Mean
2825424|NCT00337467|Secondary|Proportion of Participants With Virologic Rebound Through Week 96|Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.|Through Week 96|This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.|||proportion of participants|||Number
2825425|NCT00337467|Secondary|Cumulative Proportion of Participants Without Treatment Failure Through Week 100|This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).|Through Week 100|treated participants; n= the number at risk entering interval|||proportion of participants|||Number
2825426|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 96|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.|||percentage of participants|||Number
2825427|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 48|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 48|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.|||percentage of participants|||Number
2825429|NCT00337467|Primary|Percentage of Participants With Treatment Failure Through Week 48|Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.|Week 48|Treated participants|||Percentage of Participants|||Number
2825430|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
2825431|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
2825432|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
2825433|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||ELISA units/mL||95% Confidence Interval|Mean
2825434|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
2825435|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
2825436|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
2825437|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
2825438|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.|||participants|||Number
2825439|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
2825440|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
2825441|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
2825442|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||participants|||Number
2825443|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
2825454|NCT00337272|Secondary|Daytime Function - Despair|The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
2825444|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
2825445|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
2825446|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||milliMerck units/mL||95% Confidence Interval|Mean
2825447|NCT00337350|Primary|Change From Baseline in Acute Insulin Response to Glucose (AIRG)|Acute insulin response to glucose (AIRG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. AIRG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. AIRG measures the acute(0-10 min) beta\ cell response to a glucose load calculated by the areas under the curve higher than basal insulin values. The AIRG was assessed as the incremental area under the curve (calculated by the trapezoid rule) from 0 to 10 min of the FSIVGTT.|baseline, week 8||||Units/mL per 10 minutes||Standard Deviation|Mean
2825448|NCT00337350|Primary|Change From Baseline on Glucose Utilization (SG)|Glucose utilization (SG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. SG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SG represents the net fractional glucose clearance rate because of the increase in glucose independent of any increase in circulating insulin concentrations above baseline.|baseline, week 8||||min^-1||Standard Deviation|Mean
2825449|NCT00337350|Primary|Change From Baseline in Insulin Sensitivity|Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit change in serum insulin concentration after the intravenous glucose load (microUnits/mL).|baseline, week 8||||microUnits/mL||Standard Deviation|Mean
2825450|NCT00337285|Secondary|Change in PSQI Total Score From Baseline at Up to One Year|Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.|up to 1 year|Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.)|||Units on a scale||Standard Deviation|Mean
2825451|NCT00337285|Secondary|Number of Participants With Improvement on CGI-I|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.|Up to 1 year|ITT|||Participants|||Number
2825452|NCT00337285|Primary|Change in ADHD-RS-IV Total Score From Baseline at Up to One Year|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|up to one year|Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score)|||Units on a scale||Standard Deviation|Mean
2825453|NCT00337272|Secondary|Daytime Function - Distress|The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
2825455|NCT00337272|Secondary|Daytime Function - Fatigue|The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
2825456|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Quality of Sleep|The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Units on a Scale||Standard Deviation|Mean
2825457|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Global Sleep Impression|"The Patient Global Impression is a 7-point scale which asks How much has your sleep improved? with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement."|Once during the withdrawal period||||Participants|||Number
2825458|NCT00337272|Secondary|Quantitative Sleep Parameters - Number of Awakenings|The subject reports how many times she woke up during the night.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Awakenings||Standard Deviation|Mean
2825459|NCT00337272|Secondary|Quantitative Sleep Parameters - Total Sleep Time|The subject reports how many hours of sleep she got.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Hours||Standard Deviation|Mean
2825460|NCT00337272|Primary|Sleep Efficiency|Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.|||Percent sleep efficiency||Standard Deviation|Mean
2825461|NCT00337207|Primary|Tumoral Blood Flow Changes|To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.|Before and after treatment|This was an optional outcome measure. Data was not collected or analyzed for this outcome measure.||||||
2825462|NCT00337207|Primary|Progression-free Survival at 6 Months|The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.|After all patients have surpassed the 6 month post-treatment timepoint|1 patient became deceased due to toxicity prior to the 6 month time point and thus, was not evaluable for the 6 month progression free survival endpoint.|||Participants|||Number
2825463|NCT00337207|Primary|Safety of Treatment|"Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.|All patients that receive at least one dose of study treatment are evaluable for toxicity|||participants|||Number
2825464|NCT00337194|Other Pre-specified|Fc Gamma Receptor Polymorphisms|Fisher's exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a|Baseline|Fc gamma receptor polymorphisms were assessed in 28 participants.|||participants|||Number
2825465|NCT00337194|Other Pre-specified|sCD30 Levels|A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.|Up to day 21 of course 6|Nine participants submitted pretreatment sCD30 samples.|||U/ml||Full Range|Median
2825466|NCT00337194|Other Pre-specified|Peak Serum Level of Monoclonal Antibody SGN-30|Record the highest serum level of monoclonal antibody SGN-30 achieved.|Up to day 21 of course 6|Data was only available on 10 participants from Arm 1. (No participants from Arm II were evaluable for this endpoint as they did not receive SGN-30 per protocol.)|||mg/ml||Full Range|Median
2825467|NCT00337194|Secondary|Overall Survival (OS) At 1 Year|Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.|1 year||||percentage of participants||95% Confidence Interval|Median
2825468|NCT00337194|Secondary|Event Free Survival (EFS)|Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 10 years||||months||95% Confidence Interval|Median
2825469|NCT00337194|Primary|Number of Participants With Overall Response (OR)|The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions.|Up to 10 years||||participants|||Number
2825470|NCT00337181|Primary|Number of Participants Reaching Clinical Long Term Component Endpoints|Evaluate the vaccine effect on clinical long term endpoints: CD4 is for CD4<350 endpoint; ART is for initiation of highly-active antiretroviral therapy (HAART) endpoint; ADI is for AIDS-defining illness endpoint; A combination of multiple endpoints is listed in order of occurrences of the endpoints|66 months|Participants analyzed correlates to responders of endpoints|||Participants|||Count of Participants
2825473|NCT00337168|Secondary|Expression of Nucleoside Transporters|Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.|On average, two weeks before treatment started|Eligible patients who submitted paraffin-embedded tissue|||participants|||Number
2825474|NCT00337168|Primary|Number of Patients With Complete Remission|Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease|Between day 28 and day 35 inclusive|Eligible patients who started therapy|||participants|||Number
2825475|NCT00337129|Secondary|Participants With a Given Type of AE|The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.|Every 3 weeks while on protocol therapy, up to 3 years.|All eligible patients who started protocol treatment are included in analysis of toxicity|||participants|||Number
2825476|NCT00337129|Secondary|Overall Survival|Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.|Only eligible patients were included in the analysis.|||months||95% Confidence Interval|Median
2825477|NCT00337129|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration.||||months||95% Confidence Interval|Median
2825478|NCT00337129|Primary|Response Probability (Confirmed Complete and Partial Responses)|Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration|Only eligible patients were included in the analysis|||participants|||Number
2825479|NCT00337103|Primary|Progression Free Survival (PFS)|PFS was defined as the time (in days) from the date of randomization to the date of the first sign of disease progression based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v 1.1) or date of death, regardless of cause. Disease progression was measured by computed tomography (CT) and magnetic resonance imaging (MRI) performed on lesions targeted at baseline for tumor assessment. Disease progression (as assessed by independent review of the imaging scans) per RECIST v 1.1 was defined as at least a 20% increase in the sum of the diameters of the target lesions (taking as reference the smallest sum on study, including the baseline sum if that is the smallest), and an absolute increase of at least 5 mm. Note that the appearance of one or more new lesions was also considered as PD.|From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date 12 Mar 2012 or up to approximately 6 years|Data was analyzed using Safety Population defined as all subjects who received at least one dose of study treatment.|||Days||Full Range|Median
2825480|NCT00337103|Primary|Overall Survival (OS)|OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant died during the study, the date of death was considered the end date, 2) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 3) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.|From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years|Data was analyzed using the Intent-to-Treat Population defined as all participants who were randomized.|||Days||Full Range|Median
2825481|NCT00337077|Secondary|Proportion of Patients With Measurable Disease Response|Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.|Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry|Eligible and treated patients with measurable disease at baseline are included in this analysis.|||Proportion of participants||90% Confidence Interval|Number
2825482|NCT00337077|Primary|Proportion of Patients With PSA Response|PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.|Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years|Eligible and treated patients are included in this analysis.|||Proportion of participants||90% Confidence Interval|Number
2825483|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)|||percentage|||Number
2825484|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)|||percentage|||Number
2825485|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)|||percentage|||Number
2825487|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)|"The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21.~Higher values represent more severe discomfort."|12 weeks||||units on a scale||Standard Deviation|Mean
2825488|NCT00336895|Primary|Number of Participants With Cytomegalovirus Infection or Disease||12 weeks||||participants|||Number
2825489|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)|"The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.~The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)~The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
2825490|NCT00336856|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 30 months||||months||95% Confidence Interval|Median
2825491|NCT00336856|Secondary|Time to Progression|time from start of protocol therapy until objective tumor progression|Up to 30 months||||months||95% Confidence Interval|Median
2825492|NCT00336856|Primary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|every 6 - 8 weeks, up to 30 months||||percentage of participants||95% Confidence Interval|Number
2825493|NCT00336817|Other Pre-specified|Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period|number of patients with ACR|12 weeks||||participants|||Number
2825494|NCT00336817|Other Pre-specified|Incidence of Graft Loss or Death During the Study Period|number of patients|12 weeks||||participants|||Number
2825495|NCT00336817|Secondary|Number of Participants With Neurotoxicity||12 weeks||||participants|||Number
2825496|NCT00336817|Secondary|Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12|Creatinine levels|12 weeks||||participants|||Number
2825497|NCT00336817|Secondary|Drug Discontinuation Due to Side Effects|Drug discontinuation due to drug side effects regarding Cellcept and Myfortic.|12 weeks||||Participants|||Count of Participants
2825498|NCT00336817|Primary|Incidence of Cytomegalovirus Infection or Disease During the Study Period|number of participants|12 weeks||||participants|||Number
2825499|NCT00336817|Primary|Number of Participants With Bone Marrow Suppression|Number of participants with: Thrombocytopenia (<50,000 mm3), Leukopenia (< 2000 mm3), absolute neutrophils count ( <1000 mm3) or hemoglobin ( < 7.0 g/dL)|12 weeks||||participants|||Number
2825500|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~Constipation subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
2825501|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~The Diarrhea subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
2825502|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~The Indigestion subscale range is 4 to 28 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
2825503|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~Reflux subscale range is 2 to 14 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
2825504|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale)|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~The abdominal Pain subscale range is 3 to 21 with higher scores means worst symptoms"|screening, 2, 6 and 12 weeks||||units on a scale||Standard Deviation|Mean
2825505|NCT00336817|Primary|GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil|"The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).~The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total GSRS range of scores is 15 to 105 with higher scores meaning the worst of symptoms."|screening, 2, 6 and 12 weeks|One participant in the myfortic group was ineligible|||units on a scale||Standard Deviation|Mean
2825506|NCT00336700|Secondary|KRAS Mutational Status|KRAS mutation status in resected tumor specimens.|Up to 60 months||||percentage of participants|||Number
2825507|NCT00336700|Secondary|Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)|Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).|Up to 60 months||||percentage of participants|||Number
2825508|NCT00336700|Secondary|Estimated 1&2 Year Overall Survival (OS)|Time from from date of first study therapy to to death from any cause.|Up to 60 months||||percentage of participants||95% Confidence Interval|Number
2825509|NCT00336700|Primary|2-year Recurrence Free Survival (RFS)||Up to 60 months||||percentage of participants||95% Confidence Interval|Number
2825510|NCT00336700|Primary|1-year Recurrence Free Survival (RFS)||Up to 60 months||||percentage of participants||95% Confidence Interval|Number
2825511|NCT00336700|Primary|Recurrence Free Survival (RFS)|The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.|Up to 60 months||||months||95% Confidence Interval|Median
2825512|NCT00336583|Secondary|Worst Toxicity Grade by Patient|graded by National Cancer Institute Common Toxicity Criteria of Adverse Event version 3.0|up to 24 weeks|The 27 patients received a total of 103 cycles of the ESHAOx treatment, with a median number of four cycles per patient. Except one who was lost to follow-up after one cycle, 26 patients were assessable for toxicity.|||participants|||Number
2825513|NCT00336583|Primary|Overall Response Rate|The Overall Response Rate was measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response was evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.|up to 24 weeks|25 patients who had completed at least 3 cycles of ESHAOx study treatment were analyzed. 2 patients who did not complete 3 cycles of study treatment were excluded from the response analysis.|||pariticipants|||Number
2825514|NCT00336544|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
2825524|NCT00336479|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2825596|NCT00335829|Primary|Median Progression-free Survival|This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.|Time through study completion, an average of 1 year|PFS analysis was not conducted.||||||
2825515|NCT00336544|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations|||Participants|||Number
2825516|NCT00336544|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
2825517|NCT00336544|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.|||Participants|||Number
2825518|NCT00336505|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
2825519|NCT00336505|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations|||Participants|||Number
2825520|NCT00336505|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.|||Participants|||Number
2825521|NCT00336505|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.|||Participants|||Number
2825522|NCT00336492|Secondary|The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54|Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.|Week 54|PUCAI remission at Week 54 analysis was based on all participants randomized at Week 8 who were evaluable for PUCAI. Fifteen participants discontinued Infliximab treatment.|||Participants|||Number
2825523|NCT00336492|Primary|The Number of Participants With Clinical Response at Week 8|Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by >=30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.|Week 8|The primary efficacy endpoint analysis was based on all treated participants.|||Participants|||Number
2825525|NCT00336479|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).|||participants|||Number
2825526|NCT00336479|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||participants|||Number
2825527|NCT00336479|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
2825528|NCT00336479|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.|||percentage of participants|||Number
2825529|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
2825530|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
2825531|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
2825532|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
2825533|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
2825534|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks||||participants|||Number
2825564|NCT00336284|Primary|Home Monitoring Effectiveness|Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.|12 months|Only participants who completed at least one follow-up visit are included in the analyses.|||In-office ICD follow-up per patient year||Full Range|Mean
2825535|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|There were no participants with a change in central subfield thickness from 3 to 6 weeks in this treatment group that had a >11% increase in change of central subfield thickness from baseline to 3 weeks.||||||
2825536|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had Within a ±11% Change in Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||participants|||Number
2825537|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||Participants|||Number
2825538|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||Participants|||Number
2825539|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had Within a ±11% Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks||||participants|||Number
2825540|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg Bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Duration of effect of Bevacizumab was based on additional improvement versus maintained improvement versus worsening within 3 to 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in the DRCR.net paper, Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema.Ophthalmology 2007;114:1520-25.|3 to 6 Weeks||||Participants|||Number
2825541|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825542|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825543|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825565|NCT00336232|Primary|Plasma Phylloquinone|Plasma phylloquinone in response to phylloquinone depletion and repletion|2 months||||nmol/L||Standard Deviation|Mean
2825644|NCT00335452|Secondary|Occurrence of Major Bleeding - ASA Dose Level Comparison||30 days|The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.|||participants|||Number
2825544|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825545|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825546|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825547|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Visual Acuity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825548|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Central Subfield Thickness at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks||||letters||Inter-Quartile Range|Median
2825549|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825550|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825551|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks + laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. Retinopathy severity based on investigator discretion on clinical examination.|baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825552|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825577|NCT00336024|Secondary|Patterns of Failure|The patterns of failure for relapse/disease progression will be provided for patients treated with/without methotrexate drug in three categories, namely local, distant, and both local and distant. The number of patients with each type of failure will be listed per arm. The two groups will be compared to determine if the pattern of failure distribution is different between the two arms using Fisher exact test.|Baseline to up to 5 years|All Eligible Participants who relapsed/disease progressed in the study.|||Participants|||Count of Participants
2825553|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825554|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825555|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Visual Acuity Letter Score|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825556|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Central Subfield Thickness|Pooled Bevacizumab groups include the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks||||microns||Inter-Quartile Range|Median
2825557|NCT00336323|Secondary|Distribution of Change in Visual Acuity Over All Study Visits|Visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant.|Baseline to 3,6,9, and 12 weeks||||participants|||Number
2825558|NCT00336323|Primary|Percentage of Participants With <250 Microns or ≥ 50% Reduction in Retinal Thickening From Baseline Over All Study Visits|Central subfield retinal thickness measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading.|Baseline to 3,6,9, and 12 Weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.|||percentage of participants|||Number
2825559|NCT00336323|Secondary|Change in Visual Acuity Letter Score From Baseline Over All All Study Visits|Change in visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; positive change represents an improvement in letter score.|Baseline to 3,6,9, and 12 weeks||||letters||Inter-Quartile Range|Median
2825560|NCT00336323|Primary|Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits|Change in central subfield retinal thickness from baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading. Negative changes represent a decrease in retinal thickening.|Baseline to 3,6,9, and 12 weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.|||microns||Inter-Quartile Range|Median
2825561|NCT00336284|Secondary|Patient Initiated Follow-up|Percentage of total patient initiated inqueries that result in ER or office follow-up visits.|12 months|Only participants with at least one follow-up are included in the analyses|||percent of patient initiated follow-ups|||Number
2825562|NCT00336284|Secondary|Early Detection of Cardiac Events|Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).|12 months|Only participants with at least one follow-up are included in the analyses.|||Days||Full Range|Mean
2825563|NCT00336284|Primary|Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.|Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.|12 months|Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up.|||Percentage of participants|||Number
2825566|NCT00336024|Secondary|Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).|"Three tools are used to assess intelligence (IQ) depending on age. The range of IQ scores is 40-160 (mean=100, SD=15); range for the Processing Speed Index (PSI)=45-155. Higher scores represent better functioning. (1) Wechsler Preschool and Primary Scale of Intelligence-4th Edition (WPPSI-IV) is used for ages 2.5 to 6 years. Bug Search and Cancellation subtests are summed to calculate PSI. (2) Wechsler Intelligence Scales for Children-5th Edition (WISC-V) is used for ages 6 - 16 years. Symbol Search and Coding subtests are summed to calculate PSI. (3) Wechsler Adult Intelligence Scales-4th Edition (WAIS-IV) is used for ages 16 and older. Symbol Search and Coding subtests are summed to calculate PSI.~The Pediatric Quality of Life Inventory Version 4 (PedsQL) measures health-related quality of life (QOL). Parents complete the measure for children ages 2-17, and patients > 18 complete a self-report version. Total scores range from 0-100, with higher scores representing better QOL."|60 months (+/- 3 months)|Of the 77 eligible participants in ACNS0334, only 4 patients completed assessments in ALTE07C1 study. The targeted number of participants to achieve target power and statistically reliable results was not achieved and therefore the data is statistically uninterpretable.|||scores on a scale||Full Range|Median
2825567|NCT00336024|Secondary|Rates of Nutritional Toxicities|Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|Beginning of treatment to the end of consolidation|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825568|NCT00336024|Secondary|Rates of Gastrointestinal Toxicities|Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|Beginning of treatment to the end of consolidation|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825569|NCT00336024|Secondary|Number of Participants With Chronic/Late Hearing Loss and No Chronic/Late Hearing Loss|The number of patients who are reported to have abnormal hearing, graded according to CTCAE 4.0 or not, with onset while on therapy or when off therapy which persisted after off therapy will be reported and will be compared using Fisher exact test.|Off-treatment up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825570|NCT00336024|Secondary|Number of Participants With Secondary Malignancies|The number of patients who had secondary malignancy will be reported for this analysis due to small numbers.|Off-treatment up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825571|NCT00336024|Secondary|Number of Participants With Chronic Diabetes Insipidus|"The number of patients who had Diabetes Insipidus and on DDAVP will be reported for this analysis due to small numbers.."|Beginning of off-treatment to up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825572|NCT00336024|Secondary|Number of Participants With Chronic Low Somatomedin C|Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run.|Off-treatment up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825573|NCT00336024|Secondary|Number of Participants With Chronic Central Hypothyroidism|"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than Institutional Normal with TSH less than or equal to Institutional Normal."|Off-treatment up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825574|NCT00336024|Secondary|Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism|"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than Institutional Normal or equal to Institutional Normal with TSH level greater than Institutional Normal."|Off-treatment up to 9 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825575|NCT00336024|Secondary|Number of Participants With Acute Hearing Loss and No Acute Hearing Loss|Per protocol, hearing was assessed pretreatment and at regular specified intervals during treatment and off therapy, using DPOAE, audiogram or Brainstem Evoked Auditory. Per CTCAE V4.0 grade 3 Hearing impaired is defined as follows; Pediatric (on a 1,2,3,4, 6 and 8 kHz audiogram): hearing loss sufficient to indicate therapeutic intervention, including hearing aids, threshold shift >20 dB at 3 kHz and above in at least one ear, additional speech-language related services as indicated. Per CTCAE V4.0 grade 4 Hearing impaired is defined as follows; Pediatric Audiologic indication for cochlear implant and additional speech-language related services as indicated.|Beginning of treatment to the end of consolidation|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||Participants|||Count of Participants
2825576|NCT00336024|Secondary|Percentage of Participants With Any Acute Adverse Events|Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test.|Beginning of treatment to the end of consolidation|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2825595|NCT00335829|Primary|Time to Tumor Progression (TTP) of Targeted Lesions|Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.|6 months and 1 year||||months|||Number
2825578|NCT00336024|Secondary|Percentage of Participants With Event Free Survival (EFS)|EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1.|Baseline to up to 5 years|Per protocol all eligible patients randomized to treatment should be included in the analysis.|||percentage of participants with EFS||90% Confidence Interval|Number
2825579|NCT00336024|Secondary|Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort|The number of patients will be reported for this analysis by Molecular Sub-types of MB, CNS-PNETs/EBTs|At baseline||2020-06-30|06/2020||||
2825580|NCT00336024|Primary|Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate|At the end of consolidation, the number of evaluable patients treated with intensive chemotherapy with methotrexate who achieved CR or not will be compared to those who achieved CR or not after treated with the same intensive chemotherapy without methotrexate. The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test. Complete Response (CR) requires: CR for target lesions: disappearance of all target lesions, CR for non-target lesions: disappearance of all non-target lesions and no new lesions. No CR is any response not fitting the definition of CR.|At the end of consolidation treatment|Per protocol, only evaluable patients are included.|||Participants|||Count of Participants
2825581|NCT00335972|Primary|Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery|intravenous morphine equivalents (mg)|During Post-anesthesia care unit after surgery,an average of 4 hours||||mg||Inter-Quartile Range|Median
2825582|NCT00335972|Primary|Visual Analogue Scale (VAS) Pain Score|"Using a ruler, the score is determined by measuring the distance on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-10. 0 = no pain and 10 = worst"|pain score measured at 15, 30, 45, 60, and 90 minutes after extubation||||cm||Standard Deviation|Mean
2825583|NCT00335972|Primary|Mean Arterial Pressure||mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation||||mmHg||Standard Deviation|Mean
2825584|NCT00335959|Primary|Pathologic Complete Response|Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.|17-19 weeks|Eligible patients who completed pre-operative therapy were assessed for response.|||participants|||Number
2825585|NCT00335959|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.|Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
2825586|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycles 2 and 3|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy|6 months|14 out of the original 26 study participants completed 2 or 3 cycles of TACE and bevacizumab therapy - adverse events associated with these patients for cycles 2 and 3 assessed.|||adverse events|Adverse events||Number
2825587|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycle 1 Post-TACE|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy|Cycle 1 post-TACE - 5 weeks|1 out of the initial 26 patients did not complete the first TACE on protocol and was not included in this assessment.|||adverse events|Adverse events||Number
2825588|NCT00335829|Secondary|Safety and Treatment Toxicity - Cycle 1 Pre-TACE|Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy.|Cycle 1 pre-TACE - 2 weeks||||adverse events|Adverse events||Number
2825589|NCT00335829|Secondary|Response Rate - Based on Tumor Enhancement|"Efficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria:~Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression.~The overall response rate (ORR = CR + PR) was 60%. Disease control rate (DCR = CR + PR + SD) was 100%."|6 months||||Participants|||Count of Participants
2825590|NCT00335829|Secondary|Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle.~Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|6 months||||Participants|||Count of Participants
2825591|NCT00335829|Secondary|Overall Survival (OS)|OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.|1 year||||months||95% Confidence Interval|Median
2825592|NCT00335829|Secondary|TTP Rate at 6 Months and 1 Year|Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year|6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
2825593|NCT00335829|Secondary|Overall TTP|Overall TTP assessed via Kaplan-Meier methodology.|1 year||||months||95% Confidence Interval|Median
2825594|NCT00335829|Secondary|TTP of Nontargeted Lesions Within the Liver|TTP of nontargeted lesions assessed via Kaplan-Meier methodology.|1 year||||months||95% Confidence Interval|Median
2825597|NCT00335777|Primary|Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.|"Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). Pain free is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe)."|2 hours post treatment with study medication|Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)|||participants|||Number
2825598|NCT00335777|Secondary|Use of Rescue Therapy for Each Attack Treated Per Subject||number subjects using rescue used between 2 and 24 hrs after study drug|||||||
2825599|NCT00335777|Secondary|Subjects Historical Response to Triptan Therapy and Ergot Therapies||baseline|||||||
2825600|NCT00335777|Secondary|Pain and Associated Symptoms Assessments as Measured at Pre-dose, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose||baseline, 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr. 8 hr, 24 hr|||||||
2825601|NCT00335777|Secondary|Allodynia Assessments as Performed at Pre-dosing, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose Has Been Adminis||baseline, 15 minutes, 30 min., 1 hr., 1.5 hr, 2 hr, 4 hr, 8 hr, 24 hr|||||||
2825602|NCT00335764|Other Pre-specified|Molecular Targeted Combinations Correlative Study Initiative|Determine the relationship between tumor and blood biomarkers and clinical outcome of patients this was more an exploratory correlative and was not completed due to the negative outcome of other parts of the study|28 days|This was more an exploratory correlative and as per the pre-specified protocol, was only to be performed if the outcome of other parts of the study indicated positive results.||||||
2825603|NCT00335764|Other Pre-specified|Exploratory Correlative Laboratory Studies (Phase II)|Examination of tissue markers of signal transduction pathways by immunohistochemical analysis this was an exploratory measure and it was not explore due to the negative results of the rest of the study|28 days|this was more an exploratory correlative and as per the pre-specified protocol, was only to be performed if the outcome of other parts of the study indicated positive results.||||||
2825604|NCT00335764|Primary|Objective Response Rate in Patients With Measurable Disease (Phase II)|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|Up to 5 years||||Participants|||Count of Participants
2825605|NCT00335764|Primary|Progression-free Survival at 6 Months (Phase II)|Patients with a scan at 6 months without progressive disease Progressive disease defined as Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.|6 months|Group 3 did not reach an MTD not complete the Phase 2 portion of study, combination treatment too toxic. End points not followed for group 3 Phase 2|||weeks||95% Confidence Interval|Mean
2825606|NCT00335764|Primary|Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase 2)||1 year||||events|||Number
2825607|NCT00335764|Primary|Number of High Grade (3 and 4) Related Adverse Events of Each Combination Agent Combined With BAY 43-9006 (Phase I)|CTCAE 3.0|28 days||||Events|||Number
2825608|NCT00335764|Primary|12 Month Survival Rate (Phase II)|number of patients alive at 12 months|12 months|Group 3 did not reach an MTD Hence, did not complete the Phase 2 portion of study, combination treatment too toxic.|||Participants|||Count of Participants
2825609|NCT00335764|Primary|Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg BID (Level 1)|Group 3: PKs for Dose level 1 Tipifarnib 100mg BID|Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)|Group 3: PKs for Dose level 1 Tipifarnib 100mg BID|||ng*hr/mL||Standard Deviation|Mean
2825610|NCT00335764|Primary|Plasma Time Curve (AUC) of Group 3 Phase I Sorafenib and Tipifarnib 100mg QD (Level -1)|"Group 3: PKs for Dose level -1 100mg QD~Note that although 9 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference"|Cycle 1 (D1, D15, D28) (0,1,2,4,6,8,12,24hr post drug administration)|Group 3: PKs for Dose level -1 Tipifarnib 100mg QD Sorafenib started day 2|||ng*hr/mL||Standard Deviation|Mean
2825611|NCT00335764|Primary|Pharmacokinetic CpMax Concentration of Group 3 Sorafenib and Tipifarnib (Phase I) 100mg BID|"Group 3: patients were studied for their day 1 Cmax, and day 15 Cmax Tipifanib and Day 15 and Day 28 sorafenib~Group 3: Only PKs for Dose level 1 and -1 were collected."|Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)|"Group 3: patients were studied for their day 1 Cmax, day 15 Cmax. and Day 28 Cmax PKs for 100mg BID Tipifarnib Note that although 10 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference~Level 1 (n=10): Day 1 n=6 (4 samples not evaluable) and D15 n=5 (5 samples not evaluable)"|||ng/mL||Standard Deviation|Mean
2825612|NCT00335764|Primary|Pharmacokinetic Cpmax Group 3 Sorafenib and Tipifarnib (Phase I) 100 mg QD (Level -1)|Group 3: Only PKs for Dose level 1 and -1 were collected.|Cycle 1 = 28 day PKs D1, D15,D28 (0,1,2,4,6,8,12,24hr post drug administration)|Group 3: Only PKs for Dose level 1 and -1 were collected. Note that although 6 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ng/mL||Standard Deviation|Mean
2825645|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup||30 days|The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.|||participants|||Number
2825613|NCT00335764|Primary|Plasma Time Curve (AUC) of Group 2 Sorafenib and Temsirolimus (Phase I)|"Day 1 = 12 patients (1 sample not evaluable) Day 15 = 5 patients (8 samples not evaluable)~AUC - Area Under Curve~8 samples collected over 24 hours - 28 day PKs"|Cycle 1 (D1, D15, D28) (0,1,2,4,6,8,12,24hr post drug administration)|13 patients temsirolimus 25mg and Sorafenib at either 200mg or 400mg. 1 patient withdrew early hence specimens not analyzed in other cases samples were either missing or not enough to analyze if numbers are not 12|||mcg*hr/mL||Standard Deviation|Mean
2825614|NCT00335764|Primary|Trough Concentration Group 2 Sorafenib and Temsirolimus (Phase I)|Group 2: 12 patients were analyzed for Day 1 (1 patient not evaluable), 5 patients were analyzed for Day 15 (8 patients not evaluable)|15 days|Group 2: 12 patients were analyzed for Day 1, 5 patients were analyzed for Day 15. In both cases samples were either missing or not enough to analyze.|||ng/mL||Standard Deviation|Mean
2825615|NCT00335764|Primary|Pharmacokinetic AUC 0-12 Group 1 Sorafenib and Erlotinib (Phase I)|"8 samples collected over 24 hours on Day 1, day 15 and day 28~16 patients Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference AUC - Area Under Curve"|28Days (D1, D15, D28) (0,1,2,4,6,8,12,24hr post administration) AUC 0-12|8 samples collected over 24 hours on Day 1, day 15 and day 28 AUC 0-12 16 patients treated at 100mg erlotinib,and Sorafenib at either 200 or 400mg Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ug xhr/mL||Standard Deviation|Mean
2825616|NCT00335764|Primary|Pharmacokinetic cMax Group 1 Sorafenib and Erlotinib (Phase I)|"8 samples collected over 24 hours on Day 1, day 15 and day 28~13 total patients treated 100mg Erlotinib and either 200mg or 400mg of Sorafenib"|28days (D1, D15, D28) (0,1,2,4,6,8,12,24hr post administration)|8 samples collected over 24 hours on Day 1, day 15 and day 28 (0,1,2,4,6,8,12hr, & 24hr post administration). Note that although 16 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ng/mL||Standard Deviation|Mean
2825617|NCT00335764|Primary|Pharmacokinetic Max Concentration (Cmax) of Group 2 Sorafenib and Temsirolimus (Phase I)|Group 2: 13 patients received temsirolimus 25mg IV and 7 patients treated with 200mg Sorafenib and 6 patients treated with 400mg Sorafenib|cycle 1 ((Day1, Day15, Day28)|Group 2: total 13 patients were studied for their day 1 Cmax ,day 15 Cmax and day 28 Cmax Note that although 13 patients were accrued/analyzed some samples were incomplete or inevaluable or missing hence number analyzed difference|||ng/mL||Standard Deviation|Mean
2825618|NCT00335764|Primary|Maximum Tolerated Dose (MTD) of the Each Combination Agent Combined With a Fixed Dose of BAY 43-9006 Determined by Dose-limiting Toxicities (DLT) (Phase I)|DLT defined as: any grade 4 hematologic toxicity; grade 3 thrombocytopenia > 7 days, any grade 3/4 non-hematologic toxicity (despite maximal medical therapy), any intolerable grade 2 non-hematological, ro grade 3 hematological toxicity requiring deduction during first 28 days of treatment, any toxicity resulting in delay of >1week during first 28 days of treatment|28 days|3+3 design due to excessive toxicities of Group 3 no DLT was defined for Group 3|||mg|||Number
2825619|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)|Proportion of patients who had ciliary body infiltration at enrollment.|At Enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with CBI||95% Confidence Interval|Number
2825620|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Iris Infiltration (II)|Proportion of patients who had iris infiltration at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with II||95% Confidence Interval|Number
2825621|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)|Proportion of patients who had anterior chamber seeding at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with ACS||95% Confidence Interval|Number
2825622|NCT00335738|Secondary|Pathological Features Present at Diagnosis - Scleral Invasion (SI)|Proportion of patients that had scleral invasion at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with SI||95% Confidence Interval|Number
2825623|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding|Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with LC||95% Confidence Interval|Number
2825624|NCT00335738|Secondary|Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)|Proportion of patients who had posterior uveal invasion at enrollment.|At enrollment|Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.|||Proportion of patients with PVI||95% Confidence Interval|Number
2825625|NCT00335738|Secondary|Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.|During planned six cycles of chemotherapy|Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332.|||participants|||Number
2825626|NCT00335738|Primary|Overall Survival (OS)|OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.|At 2 Years|Only eligible patients are considered for this outcome measure. This is calculated as the total number of patients enrolled in each group with the number ineligible in each group subtracted as reported on the participant flow template.|||Estimated Probability||95% Confidence Interval|Number
2825627|NCT00335738|Primary|Event-free Survival (EFS)|EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.|At 2 years|Only eligible patients are considered in the characterization of EFS at 2 years.|||Estimated Probability||95% Confidence Interval|Number
2825628|NCT00335725|Secondary|Clinical Pregnancy Rate|clinical pregnancy rate defined as the presence of gestation sac and heart beat.|6 weeks after treatment start|patients who started the FSH treatment|||percentage of treated patients|||Number
2825629|NCT00335725|Primary|Total Number of Oocytes Retrieved|Total number of oocytes retrieved|10 days after stimulation start|patients who started the stimulation with FSH|||oocytes||Standard Deviation|Mean
2825630|NCT00335556|Secondary|Frequency of TP53 Mutations||At baseline|The analysis was supplanted by an analysis done as part of the TARGET initiative on NWTS-5 sample as a result no TP53 data was collected on AREN0321.||||||
2825631|NCT00335556|Secondary|Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization||At baseline|Eligible patients with reported INI1 mutation data.|||Count participants|||Number
2825632|NCT00335556|Primary|Toxicity Rate|Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.|Up to 4 years|Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.|||Percentage of patients||95% Confidence Interval|Number
2825633|NCT00335556|Primary|Event Free Survival Probability|Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).|4 years|Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.|||Percent Probability 4 Year EFS||95% Confidence Interval|Number
2825634|NCT00335556|Primary|Response Rate|Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non‐index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.|Up to 2 months||||Percentage of participants||95% Confidence Interval|Number
2825635|NCT00335556|Primary|Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors|The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).|4 years|Eligible patients with Stage I-IV rhabdoid tumor.|||Percentage of 4-year OS||95% Confidence Interval|Number
2825636|NCT00335556|Primary|Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)|Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS‐5 (NCT00002610).|4 years|Eligible patients with Stage II-IV DAWT.|||Percentage of 4-year OS||95% Confidence Interval|Number
2825637|NCT00335517|Primary|Number of Patients Enrolled and Recieving Injection||0-48 hours postoperatively||||participants|||Number
2825638|NCT00335504|Secondary|Adverse Events.|Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in a study, whether or not related to that participation. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 3.0. Number of adverse events per grade level.|Up to 30 days after completion of study treatment||||adverse events|||Number
2825639|NCT00335504|Secondary|Effects on Apoptosis (Caspase-3 Expression).|Tissue is examined by immunohistochemistry for cleaved caspase-3. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.|||Percent change of caspase-3||Standard Deviation|Mean
2825640|NCT00335504|Secondary|Effects on Proliferation (Ki67 Expression).|Tissue is examined by immunohistochemistry for Ki67. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.|||Percent change||Standard Deviation|Mean
2825641|NCT00335504|Primary|Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy|At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.|6 months|The population used for the analysis is patients having at least 5 rectal ACF and completing both the pre- and post-intervention MCE assessments and using intention to treat principles.|||percent change in number of ACF||Standard Deviation|Mean
2825642|NCT00335478|Primary|Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.|"If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.~Complete Response: Resolution of fever and clinical signs/symptoms of infection.~Partial Response: Resolution of fever without resolution of clinical signs of infection."|Within 72 hours of starting daptomycin||||participants|||Number
2825643|NCT00335452|Post-Hoc|Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison|This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
2825646|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level||30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
2825647|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison||30 days|The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.|||participants|||Number
2825648|NCT00335452|Secondary|Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison|Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
2825649|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison|"The primary endpoint is the first occurrence of any of the following events:~Cardiovascular death (any death with a clear cardiovascular or unknown cause),~Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)~Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal)~reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC)."|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.|||participants|||Number
2825650|NCT00335322|Secondary|Time Weighted Mean Change From Baseline Plasma HIV-RNA||144 weeks|Intent to Treat|||log copies/mL||95% Confidence Interval|Mean
2825651|NCT00335322|Primary|Time-weighted Mean Change From Baseline Plasma HIV-RNA.||48 weeks|Modified ITT; all randomised pts who started drug|||log copies/mL||95% Confidence Interval|Mean
2825652|NCT00335283|Secondary|Quality of Life Questionnaire (QOLRAD)|The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
2825653|NCT00335283|Secondary|Sino Nasal Outcome Test (SNOT-20)|SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
2825654|NCT00335283|Secondary|Rhinosinusitis Outcome Measure(RSOM-31)|RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.|Baseline, 8 weeks, and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
2825655|NCT00335283|Primary|Post Nasal Drainage Symptom Response|The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.|8 and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.|||Scores on a Scale||Inter-Quartile Range|Median
2825656|NCT00335257|Primary|Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.|Within 60 months|Study participants that were not excluded due to protocol violation|||participants|||Number
2825657|NCT00335257|Primary|Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.|Within 60 months|Study participants that were not excluded due to protocol violation|||participants|||Number
2825658|NCT00335153|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include those started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
2825911|NCT00332241|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuous throughout the study|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Data set is LOCF.|||participants|||Number
2825659|NCT00335153|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination or end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
2825660|NCT00335153|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825661|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state'.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825662|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825663|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825664|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825665|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825673|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825666|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825667|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825668|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825669|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825670|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825671|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825672|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825674|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825675|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825676|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825677|NCT00335153|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||units on a scale||Standard Deviation|Mean
2825678|NCT00335153|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||hours||Standard Deviation|Mean
2825679|NCT00335153|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||hours||Standard Deviation|Mean
2825680|NCT00335153|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.|||hours||Standard Deviation|Mean
2825689|NCT00335153|Primary|Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods|Complications of the infusion device were collected during the PEG-J Surgery and Post-PEG Long-Term Treatment periods. Pump, PEG-J, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
2825681|NCT00335153|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions regarding issues with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment at timepoint.|||units on a scale||Standard Deviation|Mean
2825682|NCT00335153|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with an assessment at timepoint.|||participants|||Number
2825683|NCT00335153|Primary|Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded) who had an assessment.|||participants|||Number
2825684|NCT00335153|Primary|Number of Participants With Sleep Attacks at Baseline|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|Baseline|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
2825685|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with given assessment.|||participants|||Number
2825686|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|up to 56 weeks|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.|||participants|||Number
2825687|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include aspartate aminotransferase (AST), upper limit of normal (ULN), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), female (f), and male (m).|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.|||participants|||Number
2825688|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Potentially clinically significant values for red blood cells (RBCs), hemoglobin, and hematocrit are specified for females (f) and males (m) separately in the category rows.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.|||participants|||Number
2825702|NCT00334815|Primary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to one year|All eligible patients, both low-risk and high-risk strata combined, who received protocol therapy.|||Participants|||Number
2825703|NCT00334802|Secondary|Pharmacokinetics - Half Life (t½)|Apparent elimination half-life.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.|||hours||Full Range|Geometric Mean
2825690|NCT00335153|Primary|Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period|Complications of the infusion device were collected during the NJ Test period. Pump, intestinal tube, NJ tube, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|NJ Test Period (from 2 to 14 days)|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
2825691|NCT00335153|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|Screening through Day 378 + 30 days|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).|||participants|||Number
2825692|NCT00335140|Primary|Complete Response Rate - Locally Reviewed|"Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.~Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks."|For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).|Eligible, treated patients|||percentage of participants||95% Confidence Interval|Number
2825693|NCT00334958|Secondary|Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase|RRATIO= 100*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase|Baseline, Days 13 to 96|ITT population|||RRATIO||Standard Deviation|Mean
2825694|NCT00334958|Secondary|Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase|Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.|Days 13 to 96|ITT population|||Seizures per 28-days (log-transformed)||Standard Deviation|Mean
2825695|NCT00334958|Secondary|Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|ITT population|||Percentage of Participants|||Number
2825696|NCT00334958|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|Intent-to-treat (ITT) population: All randomized subjects who had baseline Patient Seizure Diary data and had at least completed the titration period|||Percentage change||Full Range|Median
2825697|NCT00334893|Secondary|Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer|Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided. Please see adverse events.|From the time of their first treatment with eribulin mesylate|Data were not collected||||||
2825698|NCT00334893|Primary|Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to a total of a year||||participants|||Number
2825699|NCT00334815|Secondary|Response Rate (Confirmed or Unconfirmed Partial Response)|Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration|Only patients with measurable disease at baseline were included in the analysis of response. Among 15 patients on the Low Risk stratum, 14 had measureable disease at baseline. Among 11 patients on the High Risk stratum, 10 had measureable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2825700|NCT00334815|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every week, up to 4 years||||Months||95% Confidence Interval|Median
2825701|NCT00334815|Secondary|Progression-free Survival|From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.||||Months||95% Confidence Interval|Median
2825704|NCT00334802|Secondary|Pharmacokinetics - Area Under the Concentration Curve (AUC)|Area under the concentration curve from time zero to infinity.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.|||nanograms*hour per milliliter (ng*hr/mL)||Full Range|Geometric Mean
2825705|NCT00334802|Secondary|Pharmacokinetics - Maximum Plasma Concentration (Cmax)|Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.|||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
2825706|NCT00334802|Secondary|Number of Participants Alive at One Year (1-Year Survival)||baseline to date of death from any cause, evaluated at 1 year||||participants|||Number
2825707|NCT00334802|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease||||days||Full Range|Median
2825708|NCT00334802|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease||||months||Full Range|Median
2825709|NCT00334802|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Responders are patients with complete response or partial response."|baseline to measured progressive disease||||participants|||Number
2825710|NCT00334737|Secondary|Incidence of Retinopathy of Prematurity Stage 3 or Greater||From birth to 36 weeks gestational age||||participants|||Number
2825711|NCT00334737|Secondary|Overall Neurodevelopmental Impairment at 18-22 Months (Visual Impairment, Hearing Impariment, Cerebral Palsy, or Cognitive Score <85/<70 (NDI/Moderate NDI)||18-22 months||||participants|||Number
2825712|NCT00334737|Secondary|Object Permanence Scores at 18-22 Months|Scores are 0-3, with 3 being the best score.|18-22 months||||units on a scale||Standard Deviation|Mean
2825713|NCT00334737|Secondary|Epo Concentrations||peak from birth to 36 weeks gestational age|One hospital participating in the trial lost their samples. The number analyzed only includes those with samples.|||mU/mL||Standard Deviation|Mean
2825714|NCT00334737|Secondary|Volume of Transfusions||From birth to 36 weeks gestational age||||mL/kg||Standard Deviation|Mean
2825715|NCT00334737|Secondary|Reticulocyte Count|absolute retic count measured at the end of study|at day 60 of study||||1000 cells per microliter||Standard Error|Mean
2825716|NCT00334737|Secondary|Hematocrit||From birth to 36 weeks gestational age||||L/L||Standard Deviation|Mean
2825717|NCT00334737|Primary|Composite Cognitive Score at 18-22 Months Corrected Age|Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.|18-22 months||||BSID III compositie cognitive score||Standard Deviation|Mean
2825718|NCT00334737|Primary|Number of Transfusions During Hospitalization||From birth to 36 weeks gestational age||||number of transfusions||Standard Deviation|Mean
2825719|NCT00334633|Secondary|Recurrence of BV||baseline to 4 weeks||||Participants|||Count of Participants
2825720|NCT00334633|Primary|Cure of Bacterial Vaginosis|resolution of Amsel criteria for bacterial vaginosis|one month|ITT|||participants|||Number
2825721|NCT00334542|Secondary|Prevalence of Akt and p-Akt Activation by Contralateral Core Breast Biopsies||Baseline and week 24|Enough tissue was not collected to assess this outcome measure.||||||
2825722|NCT00334542|Secondary|Prevalence of Breast Gene (Estrogen Receptor [ER]-α and ER-β, Cyclin D2, RAR-β, Twist, RASSF1A, and HIN-1) Hypermethylation|Median change in gene promotor methylation (%M) in the contralateral breast of women with breast cancer after six months of therapy|Change from Baseline to week 24|Methylation values at both time points were only evaluable in 17 participants.|||percent methylation (%M)||95% Confidence Interval|Median
2825723|NCT00334542|Primary|Change in a Panel of Biomarkers (Contralateral Breast Density) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment mammograms for evaluation of breast density were available for 43 participants.|||percentage of change||95% Confidence Interval|Median
2825724|NCT00334542|Primary|Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment fasting lipid samples were available for 47 participants, including 45 women who completed the study and from two who discontinued the drug prior to the completion of the 24–28 weeks of drug, and are integrated in the intention-to-treat analyses|||mg/dl||95% Confidence Interval|Median
2825725|NCT00334295|Secondary|Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)|Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).|ICF (Baseline) up to 12 months (12 visits)|FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.|||units on a scale||95% Confidence Interval|Mean
2825726|NCT00334295|Secondary|Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities|number of adverse events|ICF to Last Patient Out (LPO)||||adverse events|||Number
2825727|NCT00334295|Secondary|Determination (for ITT Set): Median Survival|median overall survival (OS)|ICF to the date of death||||months||95% Confidence Interval|Median
2825728|NCT00334295|Secondary|Time to Progression of Disease (TTP-Time To Progression, for ITT Set)|median TTP|ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)||||months||95% Confidence Interval|Median
2825729|NCT00334295|Primary|Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant|Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.|up to 1 year||||participants|||Number
2825730|NCT00334282|Secondary|Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants|Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.|Baseline|Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses.|||picograms per milliliter||Standard Deviation|Mean
2825731|NCT00334282|Secondary|Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3|The concentration of pazopanib in the plasma was measured.|Day 1 and Week 3|Subgroup of enrolled participants who agreed to have blood samples collected for analysis of pazopanib in plasma. Data were missing or not collected at Week 3 for 8 participants for whom data were available on Day 1. No samples were collected at Week 3 from 2 participants.|||nanograms per milliliter||Full Range|Median
2825732|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant's self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.|||points on a scale||Standard Deviation|Mean
2825733|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (<0).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.|||points on a scale||Standard Deviation|Mean
2825734|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 [very poor quality of life] to 7 [excellent quality of life]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.|||points on a scale||Standard Deviation|Mean
2825735|NCT00334282|Secondary|Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator|Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).|Randomization until CR or PR (assessed for up to 2 years)|ITT Population. Only participants with a complete or partial response were analyzed. Only results for pazopanib are given because there were not enough placebo responders. The different number of participants analyzed is due to differences in clinical judgement, measurement, and the selection of target lesions.|||weeks||95% Confidence Interval|Median
2825736|NCT00334282|Secondary|Duration of Response|Duration of response is defined as the time from first observation of response until progression of disease or death.|Time from response until progression (up to 2 years)|ITT Population. Only results for pazopanib are given because there were not enough placebo responders.|||weeks||95% Confidence Interval|Median
2825737|NCT00334282|Secondary|Participants With Complete Response, Partial Response, or 6 Months of Stable Disease|This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a >=20% increase in target lesions. IRC, independent review committee.|Baseline until 6 months post-Baseline or progressive disease|ITT Population|||participants|||Number
2825738|NCT00334282|Secondary|Overall Response|Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.|Baseline until either response or progression (up to 2 years)|ITT Population|||participants|||Number
2825739|NCT00334282|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.|Randomization until death (up to 2 years)|ITT Population|||months||95% Confidence Interval|Median
2825740|NCT00334282|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.|Randomization until progression (up to 2 years)|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
2825741|NCT00334204|Primary|Need for Blood Transfusion||12||||participants requiring PRBC Transfusion|||Number
2825742|NCT00334204|Primary|Hemoglobin/Hematocrit After Biopsy||12 hours||||participants with hematuria|||Number
2825743|NCT00334204|Primary|Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy||12 hours||||participants with hematoma|||Number
2825744|NCT00334113|Primary|7-Day Physical Activity Recall (PAR)|A self-report measure of minutes of physical activity over the previous 7 days.|six months|Participants analyzed varies from completed participants since the completed number comes from those who stayed in the study through the 12 months (6 months post intervention). In TAU, the number who completed exceeds the number analyzed since 1 participant did not show for the 6 month assessment but did show for the 12 month follow up assessment.|||minutes per week||Standard Deviation|Mean
2825745|NCT00334074|Secondary|Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine|Patients will be monitored clinically and diagnostically using measures including blood test, bone marrow aspiration and MUGA. Toxicity assessment every week using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be performed.|Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug|Intention To Treat|||participants; with adverse events|||Number
2825746|NCT00334074|Primary|Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity|"Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia:~Complete Response (CR) was defined as normalization of marrow blasts (< 5%), recovery of normal heamtopoiesis (absolute neutrophil count >1 X 10^9/l, platelet count ≥100 X10^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support.~Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts.~Treatment failure was defined as a <25% change in marrow blasts within 30 days of starting therapy"|Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.|Intent to Treat analysis; per eligible participants enrolled in the study.|||participants|||Number
2825747|NCT00334061|Secondary|Percentage of Participants With Symptomatic Hemorrhage|All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.|24-Hour Post-Procedure||||Percentage of Participants|||Number
2825748|NCT00334061|Secondary|Percentage of Participants With All Cause Mortality||90-Days Post-Treatment||||Percentage of Participants|||Number
2825749|NCT00334061|Secondary|Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment|The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.|90-Day||||Percentage of Participants|||Number
2825750|NCT00334061|Secondary|Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment|"NIHSS is a 42 point scale to describe the neurological status of the patients:~0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death."|Discharge or 30-Days Post-Procedure||||Percentage of Participants|||Number
2825751|NCT00334061|Primary|Percentage of Participants With Device-related and Procedure-related Serious Adverse Events||3-Month Post-Procedure|All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.|||Percentage of Participants|||Number
2825752|NCT00334061|Primary|Percentage of Participants With Revascularization of the Occluded Target Vessel|"Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.~TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow."|3-Month Post-Procedure|Intention to Treat|||Percentage of Participants|||Number
2825753|NCT00333983|Primary|Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment|"The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002).~Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.~The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome."|Baseline to Final Training (6 weeks)|The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.|||units on a scale||Standard Deviation|Mean
2825754|NCT00333970|Primary|Cognitive Performance|Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).|baseline and 2 months|individuals who were randomized and completed 2 month assessments|||units on a scale||Standard Error|Mean
2825755|NCT00333879|Secondary|Accuracy in Selecting Appropriate Time to Cross Street|"Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion.~The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject."|4 trials over 30 minutes after 30 minutes of training||||participants|||Number
2825756|NCT00333879|Primary|Accuracy in Judging Direction of Traffic at Traffic Intersection|"Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me.~Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject.~The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant."|4 trials over 30 minutes after 30 minutes of training|Initial pilot study design called for 16 subjects to provide data of significance based on a power analysis. Study terminated at 4 subjects when none of the subjects could identify the location of traffic vehicles when using the intervention across multiple (4) trials.|||participants|||Number
2825757|NCT00333866|Secondary|Total Daily Acetaminophen Dose|Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||mg/day||Standard Error|Least Squares Mean
2825758|NCT00333866|Secondary|Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14|Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||mm||Standard Error|Least Squares Mean
2825759|NCT00333866|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
2825760|NCT00333866|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14|MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
2825761|NCT00333866|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
2825762|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
2825923|NCT00332202|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Number of participants with treatment-emergent adverse events.|First dose through 30 days post-study treatment discontinuation (up to 81.30 months)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2825763|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
2825764|NCT00333866|Secondary|Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group.|||Units on a scale||Standard Error|Least Squares Mean
2825765|NCT00333866|Secondary|Percentage of Participants With Optimal Sleep Assessed Using MOS-SS|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Percentage of participants|||Number
2825766|NCT00333866|Secondary|Change From Baseline in Weekly Mean Sleep Quality Score|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively.|||Units on a scale||Standard Error|Least Squares Mean
2825767|NCT00333866|Secondary|Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
2825768|NCT00333866|Primary|Patient Global Impression of Change (PGIC)|Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2825769|NCT00333866|Primary|Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)|Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.|Baseline, Week 14|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Units on a scale||Standard Error|Least Squares Mean
2825770|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (Second-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. No participants in the imatinib to IFN-a + Ara-C arm were available for testing.|||Percentage of participants|||Number
2826055|NCT00330733|Secondary|Plasma Interleukin 6|Plasma IL-6 was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.|8 and 12 weeks|Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication|||pg/ml||95% Confidence Interval|Median
2825771|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (First-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2825772|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.|||Participants|||Number
2825773|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.|||Participants|||Number
2825774|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.~Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.|||Percentage of participants|||Number
2825775|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (First-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.~Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.|||Percentage of participants|||Number
2825776|NCT00333840|Secondary|Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)|Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval|||Percentage of participants|||Number
2825777|NCT00333840|Secondary|Percentage of Participants With Event Free Survival Events (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:~progression to Accelerated Phase (AP) or Blast Crisis (BC)~loss of Complete Hematological Response (CHR)~loss of Major Cytogenic Response (MCyR) confirmed~loss of Major Cytogenic Response (MCyR) unconfirmed~increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)~death (due to any cause when reported as primary reason for discontinuation of treatment).~The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|144 months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2825778|NCT00333840|Secondary|Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:~progression to Accelerated Phase (AP) or Blast Crisis (BC)~loss of Complete Hematological Response (CHR)~loss of Major Cytogenetic Response (MCyR) confirmed~loss of Major Cytogenetic Response (MCyR) unconfirmed~increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)~death (due to any cause when reported as primary reason for discontinuation of treatment).~Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval|||Percentage of participants|||Number
2825779|NCT00333840|Primary|Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)|Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval|||Percentage of participants|||Number
2825780|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score|Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).|Week 8|Intent to Treat|||Percentage of Patients|||Number
2825781|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)|Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Week 8|Intent to Treat|||Percentage of Patients|||Number
2825782|NCT00333814|Primary|Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero|Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).|Week 8|Intent to Treat|||Percentage of Patients|||Number
2825783|NCT00333801|Secondary|Employment Outcomes (Total Gross Income From All Sources|total gross income from all sources of work including noncompetitive and competitive jobs|one year|All randomized participants (intent-to-treat)|||US dollars||Standard Deviation|Mean
2825784|NCT00333801|Secondary|Employment Outcomes (Gross Income Competitive)|total gross income (US dollars) from all competitive wages, salary, commissions|one year|All randomized participants (intent-to-treat)|||US dollars||Standard Deviation|Mean
2825785|NCT00333801|Secondary|Employment Outcomes (Hours Competitively Employed)|hours employed in a competitive (not set-aside) job|one year|All randomized participants (intent-to-treat)|||hours||Standard Deviation|Mean
2825786|NCT00333801|Secondary|Employment Outcomes (Days Competitively Employed|Number of days employed in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)|||days||Standard Deviation|Mean
2825787|NCT00333801|Secondary|Employment Outcomes (Weeks Competitively Employed)|Number of weeks employed for any time in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)|||weeks||Standard Deviation|Mean
2825788|NCT00333801|Secondary|PTSD, Depression, Disability Outcomes|Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score - lowest possible raw score) / (possible raw score range)] x 100.|one-year|All randomized participants (intent-to-treat)|||units on a scale||Standard Deviation|Mean
2825789|NCT00333801|Primary|Obtain Competitive Employment|The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.|1 calendar year|All randomized participants were included in the analysis (intent-to-treat)|||participants|||Number
2825790|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
2825791|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
2825792|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
2825793|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
2825794|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
2826056|NCT00330733|Secondary|Endothelial Function|Endothelial-mediated arterial responses using peripheral arterial tonometry (PAT; Itamar Medical, Caesarea, Israel).|Baseline and 12 weeks|Analysis was performed on all participants with available baseline and final clamp studies|||index||Standard Error|Mean
2825795|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||participants|||Number
2825796|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825797|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825798|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825799|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825800|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825801|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825802|NCT00333788|Secondary|Length of Hospital Stays During the Overall Period|Overall period corresponds to both treatment and follow-up periods in C87046.|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||days||Standard Deviation|Mean
2825803|NCT00333788|Secondary|Length of Hospital Stays During the Follow-Up Period|Follow-up period starts the day after the last injection up to 84 days after last injection.|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||days||Standard Deviation|Mean
2825804|NCT00333788|Secondary|Length of Hospital Stays During the Treatment Period|The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||days||Standard Deviation|Mean
2825805|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825806|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.~Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825910|NCT00332241|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Includes all participants with weight measurement at baseline and timepoint. Data set is LOCF.|||kilograms||Standard Error|Mean
2825807|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825808|NCT00333788|Secondary|Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study|"Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)~Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed)."|Maximum 154 weeks|Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).|||days||Full Range|Median
2825809|NCT00333788|Secondary|Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||score on a scale||Standard Deviation|Mean
2825810|NCT00333788|Secondary|Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points~CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects in remission at Last visit."|Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825811|NCT00333788|Secondary|Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).~CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects achieving clinical response at Last visit."|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825812|NCT00333788|Secondary|Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).~Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.~A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects maintaining response at Last visit."|Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825813|NCT00333788|Primary|Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)|"Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.~Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.|||percentage of participants|||Number
2825814|NCT00333775|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.|||Months||95% Confidence Interval|Median
2825815|NCT00333775|Secondary|Time to Treatment Failure|Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.|||months||95% Confidence Interval|Median
2825816|NCT00333775|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline who had a complete response or a partial response were included in the analysis.|||Months||95% Confidence Interval|Median
2825817|NCT00333775|Secondary|Percentage of Participants With a Complete Response or a Partial Response|Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2825818|NCT00333775|Primary|Progression-free Survival|Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.|||Months||95% Confidence Interval|Median
2825819|NCT00333762|Primary|Time to Complete Trial Wheelchair Course|Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.|Two years|No data was collected.||||||
2825820|NCT00333710|Primary|Hepatitis C Virus Knowledge Questionnaire|This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge|pre-treatment, post-treatment||||units on a scale||Standard Deviation|Mean
2825821|NCT00333619|Primary|Sleep Efficiency|Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.|3-month follow-up||||percentage of time asleep while in bed||Standard Deviation|Mean
2825822|NCT00333619|Primary|Pittsburgh Sleep Quality Index|The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality).|3-month follow-up||||units on a scale; 0-21||Standard Deviation|Mean
2825823|NCT00333606|Secondary|Pain Intensity|Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain|30 min||||mm||Inter-Quartile Range|Median
2825824|NCT00333606|Primary|Latencies of Auditory Evoked Potentials||before acupuncture stimulation||||ms||Standard Deviation|Mean
2825825|NCT00333437|Secondary|Mean Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO was measured before beginning and after completion of study therapy|12 months||||Liters||Standard Deviation|Mean
2825826|NCT00333437|Secondary|Mean Change in Six Minute Walk Distance|Comparison of 6-minute walk distance before beginning and after completing study therapy|12 months||||Feet||Standard Deviation|Mean
2825827|NCT00333437|Secondary|Change in Shortness of Breath (Self-reported)|Participants reported frequency of shortness of breath experienced with exertion|Baseline, 12 months||||participants|||Number
2825828|NCT00333437|Secondary|Mean Change in Bronchoalveolar Lavage (BAL) Components (Neutrophils, Eosinophils)|BAL samples were colleected from the affected lobe (as determined by lung CT scans) before beginning and after completing study therapy.|Baseline, 12 months||||Cells/uL||Standard Deviation|Mean
2825829|NCT00333437|Primary|Mean Change From Baseline in Forced Vital Capacity (FVC)|compare pre- and post-therapy FVC (post- minus pre-). Forced vital capacity (FVC) is the volume of air (liters) that can forcibly be blown out after full inspiration.|Baseline, 12 months||||Liters||Standard Deviation|Mean
2825830|NCT00333359|Secondary|Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).|Baseline and Weeks 24 and 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Results include only observed cases and do not include early termination values; as such the number of participants analyzed at each week differs from the number of participants in the Baseline characteristics summary.|||points on a scale||Standard Deviation|Mean
2825831|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||hours||Standard Deviation|Mean
2825832|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||percent change||Standard Deviation|Mean
2825833|NCT00333359|Secondary|Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||points on a scale||Standard Deviation|Mean
2825834|NCT00333359|Secondary|Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||hours||Full Range|Median
2825835|NCT00333359|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data|In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).|Week 52|Safety Population. Results at Week 52 include only Week 52 observed cases and do not include early termination values; as such, the number of participants with data at each time point differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
2825836|NCT00333359|Secondary|Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
2825837|NCT00333359|Secondary|Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
2825838|NCT00333359|Secondary|Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
2825839|NCT00333359|Secondary|Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.|Weeks 0, 1, 4, 12, 24, and 36|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||points on a scale||Standard Deviation|Mean
2825840|NCT00333359|Primary|Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||participants|||Number
2825841|NCT00333359|Primary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.|Baseline and Week 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Week 52 (end of treatment) results included only Week 52 observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.|||points on a scale||Standard Deviation|Mean
2825842|NCT00333229|Secondary|Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months||2 years|||||||
2825843|NCT00333229|Secondary|Pathologic Fractures During 24 Month||2 years|||||||
2825844|NCT00333229|Secondary|Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)||2 years|||||||
2825845|NCT00333229|Secondary|Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months||2 years|||||||
2825846|NCT00333229|Primary|Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.||24 months|Analysis was not completed as study was not adequately powered due to premature study termination.||||||
2825847|NCT00333177|Secondary|Change in Coping Strategies|Coping Response Inventory, which rates extent to which active coping strategies were used after a significant stressful life event. Range of possible scores is 1 to 4. Higher scores are better.|Baseline to 12 months|Participants with Coping Response Inventories completed for a comparable stressful life event at baseline and 12 months. This was so rare in practice that this outcome was not feasible to evaluate.||||||
2825848|NCT00333177|Secondary|Change in Motivation for Work/School|The Work Motivation scale is a factor score from the Work Personality Profile. The Work Personality Profile is a set of ratings based on interviewing the participant. Scores at each occasion can range from 8 to 32, with higher indicating better motivation. Scores reported here are changes from baseline to 12 months, which could range from -24 to 24 with higher being better.|Baseline to 12 months|Participants in school or jobs at baseline and 12 months, which allows change in Work Personality Profile ratings to be assessed.|||score on a scale||Standard Deviation|Mean
2825849|NCT00333177|Secondary|Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)|Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.|12 months after randomization|All participants with SUMD-R data at 12-month point.|||score on a scale||Standard Deviation|Mean
2825850|NCT00333177|Secondary|Retention in Treatment|Days after randomization that a participant continued to receive at least the assigned CT or HBT psychosocial treatment. If a participant needed to end the assigned medication condition (RLAI vs. Oral Ris), they continued in the psychosocial treatment so this outcome focused on the days in the assigned psychosocial treatment. Possible range is 1 to 365, with higher being a better outcome.|12 months|All participants who received Individual Placement and Support|||days||Standard Deviation|Mean
2825851|NCT00333177|Secondary|Exacerbation or Relapse of Psychotic Symptoms|Dichotomous measure: Presence of any of 3 psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring after randomization and until end of study participation (up to 12 months post baseline). BPRS was administered every two weeks throughout study participation.|Occurence after randomization and until end of study participation (up to 12 mos.)|A priori hypothesis was that RLAI would lead to fewer psychotic exacerbations/relapses than Oral Ris. No effect of CT vs. HBT was hypothesized, so CT and HBT conditions were merged within each medication administration condition.|||participants|||Number
2825852|NCT00333177|Secondary|Maintenance of Work/School Attendance|Modified Work Section of the Social Adjustment Scale (SAS) was used to calculate the total number of weeks in school or competitive work. Range of possible values is 0 to 52, with higher numbers being better outcome.|12 months|Participants who were served by the Individual Placement and Support specialist|||weeks||Standard Deviation|Mean
2825853|NCT00333177|Secondary|Work Behavior Inventory (WBI) Quality of Work/School Performance|Change in rating on quality of work/school performance based on patient, employer, and/or teacher reports. The Quality of Work rating at baseline was subtracted from the same rating at 12 mos. Higher scores are better outcome.|Baseline to 1 year|This measure could be rated only for individuals who were in school or working at baseline and at 12 months, so it proved not to be useful due to the infrequent return to school or work by baseline.|||score on a rating scale||Standard Deviation|Mean
2825854|NCT00333177|Primary|Work/School Functioning (Global Functioning Scale: Role)|Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.|Baseline to 12 months|Participants who received services from the Individual Placement and Support specialist.|||Changes on a 10-point scale||Standard Deviation|Mean
2825855|NCT00333177|Primary|Average Medication Non-adherence|5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.|Averaged over study participation (up to 12 months)|A priori hypothesis was that long-acting injectable risperidone would result in better medication adherence than oral risperidone, so CT and HBT groups were merged within each medication administration condition.|||units on a 5-point scale||Standard Deviation|Mean
2825856|NCT00333177|Primary|Work/School Functioning (Global Functioning Scale: Role)|Change in role functioning from baseline to the 6 month point (rated on a scale from 1= Extreme Role Dysfunction to 10 = Superior Role Functioning) is presented here.|Baseline to 6 months|Participants who received services from the supported education/employment specialist|||Changes on a 10-point scale||Standard Deviation|Mean
2825857|NCT00333177|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)|Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.|Measured at baseline and 12 months|All participants with MCCB outcome data.|||T scores||Standard Error|Mean
2825858|NCT00333138|Secondary|Mean Trough Blood Concentrations of FTY720|For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient's steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.|Month 3 and 6|Pharmacokinetics population included all the patients who had sample collected and analysis was performed|||ng/mL||Standard Deviation|Mean
2825859|NCT00333138|Secondary|Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients|The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6,12,60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. A patient at risk are those continuing in the study without an event before the specified timepoint The n denotes number of patients at risk."|||percentage of participants||95% Confidence Interval|Number
2825860|NCT00333138|Secondary|Change From Baseline in Volume of Total T2-weighted Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.|Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"|||mm^3||Standard Deviation|Mean
2825861|NCT00333138|Secondary|Volume of T2-weighted Lesions|Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"|||mm^3||Standard Deviation|Mean
2825862|NCT00333138|Secondary|Mean Number of New T2-weighted Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"|||GD enhanced T2 lesions||Standard Deviation|Mean
2825863|NCT00333138|Secondary|Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit|A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6 and 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during core study were included in the ITT population. The n number of patients with T2 and T1 information recorded at scan"|||percentage of paticipants|||Number
2825864|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Last observation (Up to 80 months in average)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
2825865|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 60 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
2825866|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 12 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
2825867|NCT00333138|Secondary|Percentage of Participants Free of T1-weighted Lesions|A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis. The n in each category indicates number of patients wih information recorded at scan"|||percentage of participants|||Number
2825868|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 6 (Core)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.|||GD- enhanced T1 lesions||Standard Deviation|Mean
2825869|NCT00332839|Secondary|Changes in Proteinuria|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months|||||||
2825870|NCT00332839|Secondary|Changes in Cardiovascular Risk|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months|||||||
2825871|NCT00332839|Secondary|Number of Participants Who Experienced Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths thorughout the prospective and follow-up phases of the study.|12 months|The safety set, which included all randomized participants, comprised the analysis population.|||Participants|||Number
2825872|NCT00332839|Secondary|Evolution of Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months|||||||
2825873|NCT00332839|Secondary|Occurrence of Treatment Failures|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months|||||||
2825874|NCT00332839|Secondary|Biopsy Proven Acute Rejection, Graft Loss, and Death|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months|||||||
2825875|NCT00332839|Primary|Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months|||||||
2825876|NCT00332722|Secondary|Neck Disability Index (NDI)|Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.|2 years||||units on a scale||Standard Deviation|Mean
2825877|NCT00332722|Primary|Numeric Rating Scale (NRS)|Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.|over 2 years|A sample size of 60 patients for each group was chosen.|||units on a scale||Standard Deviation|Mean
2825878|NCT00332709|Secondary|Change in Z-Score From Baseline to Month 12|(DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis|||Z-Score||Standard Deviation|Mean
2825879|NCT00332709|Secondary|Change in T-Score From Baseline to Month 12|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis.|||T-Score||Standard Deviation|Mean
2825880|NCT00332709|Primary|Change in Z Score From Baseline to Month 36|Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis.|Baseline, month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||Z-Score||Standard Deviation|Mean
2825881|NCT00332709|Primary|Change in T-score From Baseline to Month 36|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline and Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy.Participants with observations at both baseline and endpoint were included in the analysis.|||T-Score||Standard Deviation|Mean
2825882|NCT00332709|Primary|Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36|"Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA) scan.~ANCOVA model was used in the analysis where: Variable = Baseline, Center, Treatment BMD = (Month 36 BMD-Baseline BMD)/Baseline BMD*100."|Baseline, Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||Percent Change in BMD||Standard Deviation|Mean
2827210|NCT00323635|Secondary|Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;|State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.|2 weeks|No data collected or analyzed for the outcome measures.||||||
2825883|NCT00332709|Secondary|Median Disease Free Survival (DFS)|Disease Free Survival is measured in days and represents the number of days participants were progression free. Progression free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Median disease free survival is the time when 50% of the patients had a recurrence.|36 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. The median disease free survival was not observed because patients in the combination therapy did not have any recurrences.|||Months||95% Confidence Interval|Median
2825884|NCT00332709|Secondary|Number of Participants With Any Kind of Fractures, by Visit.|Number of participants with fractures of any type since the last visit|Baseline, Month 6, 12, 18, 24 , 30 and 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations from baseline to month 36 were included in this analysis.|||Participants|||Number
2825885|NCT00332709|Secondary|Change in Bone Mineral Density From Baseline to 12 Months|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|Baseline, 12 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||g/cm^2||Standard Deviation|Mean
2825886|NCT00332709|Primary|Change in Bone Mineral Density (BMD) From Baseline to Month 36|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|at 36 months as compared to baseline|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.|||Percent||Standard Deviation|Mean
2825887|NCT00332696|Secondary|Participant's Quality of Life Using the Edmonton Scale|The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.|Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3|"Intent-to-treat population consisted of all participants who received at least one dose of study drug. n in each of the categories is the number of participants who had Quality of Life data at that time point."|||Scores on a scale||Standard Deviation|Mean
2825888|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 3|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.|||Participants|||Number
2825889|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 2|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.|||Participants|||Number
2825890|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|1 Month|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.|||Participants|||Number
2825891|NCT00332696|Secondary|Number of Participants With Relief From Obstruction at Day 7 and Day 14|Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.|Day 7 and Day 14|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2825892|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14.|Day 14|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.|||Participants|||Number
2825893|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7.|Day 7|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.|||Participants|||Number
2825894|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.|Day 1|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2825895|NCT00332696|Secondary|Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14|The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.|Day 1, Day 7 and Day 14|"Intent-to-treat population consisted of all randomized participants who received study drug. n in each of the categories is the number of participants with data at the given time point."|||Vomiting episodes||Standard Deviation|Mean
2825896|NCT00332696|Secondary|Number of Participants With Treatment Success From Day 5 to Day 7|Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).|Day 5 to Day 7|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2827211|NCT00323635|Primary|Relationship of Incontinence to Urge or Stress|4-grade scale|Duration of study|No data collected or analyzed for the outcome measures.||||||
2825897|NCT00332696|Primary|Number of Participants With Treatment Success From Day 10 to Day 13|"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause."|Day 10 to Day 13|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
2825898|NCT00332644|Primary|7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed|"Smoking status was assessed both as 7-day point-prevalence abstinence (Have you smoked at all, even a puff, in the last 7 days?) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia)."|6 months post quit date||||participants with<10 ppm exhaled CO|||Number
2825899|NCT00332605|Primary|Penn Craving Scale|used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.|beginning and at each visit until the end of their participation in the study|Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).|||units on a scale||Standard Deviation|Mean
2825900|NCT00332579|Primary|Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)|The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).|K-YBOCS is done at each visit by the investigator.|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
2825901|NCT00332488|Secondary|Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)||Week 24|Intent to Treat: Subjects who stayed on original treatment|||percentage of total hemoglobin||Standard Deviation|Mean
2825902|NCT00332488|Secondary|Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue|(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)|Baseline to Week 12|Intention to Treat (ITT) Population for patients with available data|||Percentage of total hemoglobin||Standard Deviation|Mean
2825903|NCT00332488|Primary|Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue||Baseline to Week 12|Intention to Treat (ITT) Population with Last Observation Carried Forward|||Percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
2825904|NCT00332462|Secondary|Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation|The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.|3 or 6 months after transplantation|Intention-to-treat (ITT) population.|||Participants|||Number
2825905|NCT00332462|Primary|Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation|Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.|3 months|Intention to treat (ITT) population|||Participants|||Number
2825906|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score|Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).|||Percent change||95% Confidence Interval|Mean
2825907|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis|Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).|||Percent change||95% Confidence Interval|Mean
2825908|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Patient Global Assessment|Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).|||Percent change||95% Confidence Interval|Mean
2825909|NCT00332332|Primary|Participants With a Status of Mild or Better on Physician Global Assessment at Month 12|The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.|Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.|||Participants|||Number
2827212|NCT00323635|Primary|Number of Incontinence Episodes;|Number|Duration of Study|No data collected or analyzed for the outcome measures.||||||
2825912|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Deviation|Mean
2825913|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units of a scale||Standard Error|Mean
2825914|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825915|NCT00332241|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||participant|||Number
2825916|NCT00332241|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825917|NCT00332241|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.|||units on a scale||Standard Error|Mean
2825918|NCT00332202|Secondary|Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte||Month 2, Month 4: Predose|All participants who received at least one dose of the study drug and had evaluable PK data.|||nanomole/liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2825919|NCT00332202|Secondary|Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression|Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining).|Baseline to 94.5 months|All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.|||percentage of participants||95% Confidence Interval|Number
2825920|NCT00332202|Secondary|Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells|Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.|Baseline to 24 months (2 years)|All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.|||percentage of participants||95% Confidence Interval|Number
2825921|NCT00332202|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) Score|The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.|Baseline, Month 6; Baseline, Month 24; Baseline, Month 33|All randomized participants who completed at least one EQ-5D assessment.|||Units on a Scale||Standard Error|Mean
2825922|NCT00332202|Secondary|Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score|The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.|Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36|All randomized participants who completed at least one FACT-Lym assessment.|||Units on a Scale||Standard Error|Mean
2825924|NCT00332202|Secondary|Overall Survival|Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.|Baseline to Date of Death from Any Cause (up to 80.30 months)|All randomized participants. Overall survival is censored at the last date of contact for participants who have no reported death. The number of censored participant data for enzastaurin and placebo is 404 (80.2%) and 205 (80.7%), respectively.|||Month|||Number
2825925|NCT00332202|Secondary|Event-Free Survival at 2 Years|Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.|Baseline to 2 Years|All randomized participants.|||Proportion of participants||95% Confidence Interval|Number
2825926|NCT00332202|Secondary|Event-Free Survival|Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.|Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)|All randomized participants. EFS is censored at the last assessable disease-free assessment for participants who are alive, have not progressed or started new anticancer treatment. The number of censored participant data for enzastaurin and placebo is 364 (72.2%) and 176 (69.3%), respectively.|||Month|||Number
2825927|NCT00332202|Secondary|Disease Free Survival at 2 Years|Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.|Baseline to 2 Years|All randomized participants.|||proportion of participants||95% Confidence Interval|Number
2825928|NCT00332202|Primary|Overall Disease-Free Survival|Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)|All randomized participants. DFS is censored at the last assessable disease free assessment for participants who are alive or have not progressed. The number of censored participant data for enzastaurin and placebo is 369 (73.2%) and 180 (70.9%), respectively.|||Month||95% Confidence Interval|Median
2825929|NCT00332189|Secondary|Following Blood Phe Levels.|There were no pre-specified efficacy analysis, blood Phe samples were taken at each visit. Blood Phe concentrations remained within levels consistent with local clinical site recommendations for blood Phe control.|Baseline through Final Visit (a Maximum of 30 months) with blood phe samples taken at months 3 and 6 then at 6 month intervals|The population includes all subjects who received at least one dose of study drug during the study and had at least one measurement of blood Phe level.|||micromoles per liter||Standard Deviation|Mean
2825930|NCT00332189|Primary|Tabulation of the Incidence and Frequency of All AEs and SAEs That Occur Throughout the Study.|Safety was assessed with regards to the rate and type of AEs, clinically significant changes to vital signs and/or physical examination findings, and clinically significant changes in laboratory test results.|Baseline through Final Visit (a Maximum of 30 months) with AEs collected at month 3 and 6 then at 6 month intervals|Percentage of total population who experienced an AE or SAE presented here. For full list of SAEs, and AEs experienced with a frequency of greater than 5%, see the Reported Adverse Event section.|||percentage of subjects reporting events|||Number
2825931|NCT00332163|Secondary|Change From Baseline in Overall Dermatologic Quality of Life Index (DLQI) Score|Skin-related quality of life was assessed using the DLQI. The DLQI questionnaire asks participants to evaluate the degree that their skin condition has affected their quality of life in the last week. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); The DLQI score is calculated by summing the scores for all questions, resulting in a maximum of 30 and a minimum of 0; higher scores indicate a more impaired quality of life.|Baseline and Weeks 2, 3, 4, 5, 6 and 7|Patient Reported Outcomes (PRO) Analysis Set (randomized participants who signed informed consent before protocol-specified procedures, received at least 1 dose of panitumumab, with a non-missing baseline overall DLQI score and who had at least 1 post-baseline non-missing overall DLQI score) with available data at each time point.|||units on a scale||Standard Deviation|Mean
2825932|NCT00332163|Secondary|Progression-free Survival|Defined as the time from the date of randomization to the first date of observed disease progression or death due to any cause (whichever comes first). Participants who were alive and had not progressed while on study were censored at the date of last progression-free tumor assessment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
2825933|NCT00332163|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to the date of death. Participants who did not die while on study or who were lost-to-follow-up were censored at their last contact date. Overall survival was analyzed using all data regardless of whether it was collected during second- or third-line treatment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
2825941|NCT00332163|Secondary|Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|The percentage of participants with a most severe grade of 2, 3 or 4 specific skin toxicity of interest reported during the 6-week skin treatment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
2825934|NCT00332163|Secondary|Time to Progression|"Time from the date of randomization to the date of observed disease progression or death due to disease progression. Participants who did not have documented disease progression were censored at the date of last tumor assessment; participants who died for reasons other than disease progression while on study were censored at the date of death. PD: At least a 20% increase in the size of target lesions, recorded since the treatment started, or at least a 25% increase in size of non-target lesions and the lesion(s) measure > 10 mm in one dimension, or the appearance of one or more new lesions.~Time to progression was analyzed using the Kaplan-Meier method. This analysis excludes any data collected during follow-up for participants who began third-line treatment."|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
2825935|NCT00332163|Secondary|Time to Treatment Failure|Time-to-treatment failure is defined as the time from the date of randomization to the first date of any of the following events: discontinuation of study therapy due to any reason (except for complete response and curative surgery), progression of disease, or death due to any cause. Participants who did not discontinue, who were still alive, and who did not have disease progression were censored at the date of last contact. Time to treatment failure was analyzed using the Kaplan-Meier method.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set|||months||95% Confidence Interval|Median
2825936|NCT00332163|Secondary|Rate of Disease Control at First Scheduled Assessment|Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Disease control rate is defined as the percentage of participants with a CR, PR or stable disease (SD) at the Week 9/10 assessment visit and a corresponding response (CR or PR) confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. SD: Neither sufficient shrinkage or increase in target lesions to qualify for PR or PD, with no progression of non-target lesions and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who prematurely discontinued without a postbaseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13 or 14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2825937|NCT00332163|Secondary|Best Overall Response Rate|Best overall response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) while on study. Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified RECIST criteria. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or PD (≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Response was assessed at Weeks 9 and 13 and then every 8 weeks for the Q2W regimen, or at Weeks 10, 14, 22 and then every 9 weeks for the Q3W regimen until the end of treatment; median treatment duration was 13 and 17 weeks in each group respectively.|Primary Analysis Set; participants who prematurely discontinued without a post-baseline tumor assessment or with an observed CR or PR that was not confirmed were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2825938|NCT00332163|Secondary|Response Rate at First Scheduled Assessment|Tumor response was assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) at the Week 9/10 assessment visit and a corresponding CR or PR confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD; ≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who discontinued prematurely without a post-baseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13/14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2825939|NCT00332163|Secondary|Percentage of Participants With Panitumumab Dose Reductions Due to the Specific Skin Toxicities of Interest||6 weeks|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
2825940|NCT00332163|Secondary|Time to First Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|Time to the first most severe grade ≥ 2 of all the specific skin-related toxicities of interest was defined as the time from the first dose of panitumumab to the date of the first occurrence of the most severe specific ≥ grade 2 skin toxicity of interest during the 6-week skin treatment period. Participants who did not experience any specific skin-related toxicity of grade ≥ 2 were censored at their last skin toxicity assessment during the 6-week skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set|||weeks||95% Confidence Interval|Median
2825998|NCT00331422|Secondary|Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration|Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.|From Baseline to up to 12 weeks (4 courses of therapy)||||Participants|||Number
2825942|NCT00332163|Secondary|Time to First Occurrence of Specific Grade 2 or Higher Skin Toxicities of Interest|The time to the first occurrence of specific grade 2 or higher skin toxicities of interest was defined as the time from the first dose of panitumumab to the date of first occurrence of specific ≥ grade 2 skin toxicities of interest. Participants who did not experience specific skin-related toxicities were censored at their last skin toxicity assessment during the skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set|||weeks||95% Confidence Interval|Median
2825943|NCT00332163|Secondary|Percentage of Participants With Any Grade 2 or Higher Skin Toxicity of Any Type During the 6-week Skin Treatment Period|"The percentage of participants who developed at least 1 incidence of ≥ grade 2 skin toxicities of any type during the 6-week skin treatment period. Analysis of this endpoint was based on adverse event data associated with the Skin and Subcutaneous Tissue Disorders system organ class. Adverse events were graded according to the National Cancer Institute (NCI) CTCAE version 3.0."|6 weeks|Primary Analysis Set|||percentage of participants||95% Confidence Interval|Number
2825944|NCT00332163|Primary|Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period|Skin toxicities were assessed by the study clinician and graded according to the modified Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary analysis set (all randomized participants who provided informed consent before protocol-specific procedures and who received at least 1 dose of panitumumab)|||percentage of participants||95% Confidence Interval|Number
2825945|NCT00331864|Primary|Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye|"Grade 3 targeted AEs included:~4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days~≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection~sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days~new retinal tear or detachment involving the macula~new vitreous hemorrhage >2+ severity not resolving within 14 days~new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea"|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.|||Percentage of Participants|||Number
2825946|NCT00331864|Secondary|Total Number of Treatments|Total number of treatments administered during the entire treatment period (Month 0 to 11).|Baseline (Month 0) to Month 11|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.|||Treatments||Standard Deviation|Mean
2825947|NCT00331864|Secondary|Time to the First Retreatment After Month 2|"Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.~Criteria for re-treatment:~a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)~a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)"|Month 2 to Month 11|Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis.|||Months||Inter-Quartile Range|Median
2825948|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Micrometers||Standard Deviation|Mean
2825949|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Micrometers||Standard Deviation|Mean
2825950|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.~BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
2825951|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.~BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.|||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
2825952|NCT00331864|Primary|Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye|Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.|||Percentage of Participants|||Number
2825953|NCT00331799|Primary|Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks|CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2825954|NCT00331773|Other Pre-specified|Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses||From baseline to 5 years from the start of treatment.|||||||
2825955|NCT00331773|Secondary|Statistical Modeling of Genomic Biomarkers||Baseline biomarker collection. Analysis would occur after the primary endpoint analysis.|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2825956|NCT00331773|Secondary|Assessment of Trade-off Between Disease-free Survival and Quality of Life.|To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou's multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D.|From baseline to 5 years from the start of treatment|This analysis was not conducted because there were no differences in EQ-5D scores. See results presented for Outcome Measure 10: Evaluation and Comparison of the Cost-utility of Each Treatment Arm Using EQ-5D.||||||
2825957|NCT00331773|Secondary|EQ-5D Scores|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 ―Worst health stat and 1 ―Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.|Baseline, 6 months, 12 months, 24 months, and 5 years|Eligible patients with a baseline or follow-up EQ-5D score who did not withdraw consent|||units on a scale||Inter-Quartile Range|Median
2825958|NCT00331773|Secondary|Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25|"Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response (Not at all, A little, Quite a bit, Extremely, rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value."|Baseline, 6 months, 12 months, 24 months, and 5 years|Eligible patients with a follow-up HSCL-25 who did not withdraw consent|||units on a scale||Standard Deviation|Mean
2825959|NCT00331773|Secondary|The Utilization of Sexual Medications/Devices Questionaire|"The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of Yes responses to the following questions are reported: Do you have a penile prosthesis, Have you used an medications or devices to aid or improve erections?."|Baseline, 6, 12, and 24 months, and 5 years|Eligible patients answering the questionaire, who did not withdraw consent|||percentage of participants|||Number
2825960|NCT00331773|Secondary|Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC|Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.|Baseline, 6, 12, and 24 months, and 5 years|Eligible patients with both a baseline and follow-up EPIC domain score, who did not withdraw consent|||units on a scale||Standard Deviation|Mean
2825961|NCT00331773|Secondary|Frequency of Patients With GU and GI Acute and Late Toxicity|The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.|Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.|All eligible patients who started study treatment and did not withdraw consent|||participants|||Number
2825962|NCT00331773|Secondary|Five-year Overall Survival Rate|Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2825963|NCT00331773|Secondary|Five-year PSA Failure Rate|"Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint Freedom from biochemical recurrence, it defines the endpoint as The time to PSA failure. An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/dl. Time to biochemical failure was measured from study entry until the date of failure."|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2825964|NCT00331773|Secondary|Five-year Disease-specific Survival Rate|"An event was death in association with any of the following conditions:~Primary cause of death certified as due to prostate cancer~Further clinical tumor progression occurring after initiation of salvage anti-tumor (e.g., (androgen suppression) therapy~A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy~Disease progression in the absence of any anti-tumor therapy~Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events."|Analysis occurs after all patients have been followed for five years.|All eligible patients|||percentage of participants||95% Confidence Interval|Number
2825965|NCT00331773|Secondary|Five-year Local Progression Rate|Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.|Analysis occurs after all patients have been followed for five years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2825966|NCT00331773|Primary|Five-year Disease-free Survival (DFS) Rate|Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.|Analysis occurs after all patients have been followed for five years.|Eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2825967|NCT00331760|Secondary|Rate of Overall Survival at Five Years|Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to five years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825968|NCT00331760|Secondary|Rate of Disease-free Survival at Five Years|Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.|From registration five years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825969|NCT00331760|Secondary|Rate of Distant Metastases at Five Years|Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.|From registration to five years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825970|NCT00331760|Secondary|Rate of Local-regional Failure at Five Years|Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.|From registration to five years.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825971|NCT00331760|Secondary|Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant|Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.|From start to end of chemotherapy, approximately five weeks from registration.|Eligible patients in the chemotherapy group (cervical cancer patients) who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825999|NCT00331422|Secondary|Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Week 16 (4 weeks after 4th course)||||Participants|||Number
2825972|NCT00331760|Secondary|Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.|From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825973|NCT00331760|Secondary|Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.|From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825974|NCT00331760|Secondary|Percentage of Patients With Grade 2+ Bowel Adverse Events|Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.|From the start of treatment to 90 days.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2825975|NCT00331760|Primary|Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)|"Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.~For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%."|IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.|All eligible patients.|||participants|||Number
2825976|NCT00331682|Secondary|Overall Survival|Will be computed using Kaplan-Meier methods.|Between the start of treatment until patient death, assessed up to 2 years||||months||Full Range|Median
2825977|NCT00331682|Secondary|Time to Progression|Will be computed using Kaplan-Meier methods.|Between the start of treatment until the criteria for progression are met, assessed up to 2 years||||weeks||Full Range|Median
2825978|NCT00331682|Primary|Objective Response Rate as Measured by RECIST Criteria|Objective response rate as measured by RECIST criteria|Up to 2 years||||participants|||Number
2825979|NCT00331630|Other Pre-specified|Circulating Tumor Cell Measurement|Circulating tumor cell measurement will be assessed by lab tests done at baseline, then before each study treatment cycle begins (1 cycle = 21 days)|At baseline, then before each study treatment cycle begins (1 cycle = 21 days)|||||||
2825980|NCT00331630|Secondary|Side Effects From the Combination of Abraxane and Lapatinib|"Side effects from the combination of Abraxane and Lapatinib will be assessed using CTCAE 3.0. Side effects that were related to study treatment and grade 3 or higher were collected where:~Grade 1= Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death"|At baseline, then before the start of each study treatment cycle (1 cycle = 21 days) begins||||participants|||Number
2825981|NCT00331630|Secondary|Epidermal Growth Factor Receptor (EGFR), and Matrix Metalloproteinases (MMPs), Measured at Baseline and After Completion of Study Treatment|"Epidermal growth factor receptor (EGFR), HER2/neu, matrix metalloproteinases (MMPs), and transforming growth factor (TGF-β) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days) with expressions analyzed by light microscopy in invasive breast cancer regions.~MMP2 cytoplasmic staining intensity was assigned a score:~0=no reactivity,~=1-10% of tumor cells reactive,~=11-25% of tumor cells reactive,~= 26-50% of cells reactive,~= more than 50% of cells reactive~Greater than or equal to 2+ score was considered positive for expression.~EGFR membrane staining was assigned a score:~0 = no staining or faint staining in less than 10% of cells~= faint incomplete membrane staining in more than 10% of cells~= weak to moderate complete membrane staining of more than 10% of cells~= strong complete membrane staining in more than 10% of tumor cells"|At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )|Data for HER2/neu and transforming growth factor (TGF-β) was not collected or analyzed.|||participants|||Number
2825982|NCT00331630|Secondary|Angiogenesis (vW, CD34) Markers as Measured at Baseline and After Completion of Study Treatment|"Angiogenesis (vW, CD34) markers will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Expressions were analyzed by light microscopy in invasive breast cancer regions.~Tumor cells were assigned a score:~0 = no staining~weak staining less than 1% of tumor cells~= medium staining in 1-10% of tumor cells/weak staining in less than 1% of tumor cells~= medium or strong staining in more than 10% of the tumor cells. Capillary density was assessed in breast sections stained for CD34 at a x200 magnification by counting the number of capillaries per field with five fields per slide and results expressed as the average number of capillaries per field."|At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )||||average number of capillaries per field||Standard Deviation|Mean
2827213|NCT00323635|Primary|Urgency|Level of urgency for 7 days, graded 1 to 4,|Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;|No data collected or analyzed for the outcome measures.||||||
2825983|NCT00331630|Secondary|Apoptosis (Cleaved Caspase-3) Measured at Baseline and After Completion of Study Treatment|Apoptosis/cleaved caspase-3 (CC3) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Scoring was based on the degree of staining (0=more than 90% of tumor cells with no staining, 1= more than 90% of tumor cells have weak staining, 2= more than 90% of tumor cells have moderate staining, 3= more than 90% of tumor cells have strong staining). CC3 scores were counted on a maximum of 10 randomly selected x40 high-power fields with an eyepiece grid of 10x10 squares containing representative sections of tumor and calculated as percentage of positively stained cells to total tumor cells (Percent Score method) CC3 labeling Index (LI) as assessed by counting a maximum of 1,000 malignant cells at x400 magnification.|At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )||||Labeling Index||Standard Deviation|Mean
2825984|NCT00331630|Secondary|Proliferation (Ki67) Measured at Baseline and After Completion of Study Treatment|Correlation of proliferation (Ki67) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days). Ki67 scoring was performed based on degree of staining (0= no staining, 1=weak nuclear staining, 2=moderate nuclear staining, 3=strong nuclear staining). Ki67 scores were counted on a maximum of 10 randomly selected x40 high-power fields with an eyepiece grid of 10x10 squares containing representative sections of tumor and calculated as percentage of positively stained cells to total tumor cells (Percent Score method) Ki67 labeling Index (LI) as assessed by counting a maximum of 1,000 malignant cells at x400 magnification.|At baseline, then after 4 cycles of study treatment (1 cycle = 21 days )||||Labeling Index||Standard Deviation|Mean
2825985|NCT00331630|Secondary|Pathologic Complete Response (pCR)|Pathologic Complete Response (pCR) will be assessed by breast biopsy at baseline and after 4 cycles of study treatment (1 cycle = 21 days) and at surgery. This will be defined as the number of patients that show a pCR after surgery. pCR is defined as the absence of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|At baseline, then after 4 cycles of study treatment (1 cycle = 21 days ) and at surgery|One patient did not have an ultrasound after 4 cycles of treatment prior to surgery and one patient was lost to follow up before undergoing surgery|||Count of Participants|||Number
2825986|NCT00331630|Primary|Clinical Response Rate (cRR)|"cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum.~Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study.~Progressive Disease <=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)|One patient did not have an ultrasound after 4 cycles of treatment prior to surgery|||participants|||Number
2825987|NCT00331552|Secondary|Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II)|Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).|Up to 24 weeks||||Participants|||Count of Participants
2825988|NCT00331552|Secondary|Overall Survival (Phase II)|Kaplan-Meier estimate assessed at 18 months|18 months||||survival probability||95% Confidence Interval|Number
2825989|NCT00331552|Secondary|Progression-free Survival (Phase II)|Kaplan-Meier estimate assessed at 18 months|18 months||||progression free survival probability||95% Confidence Interval|Number
2825990|NCT00331552|Secondary|Time to Progression (Phase II)|Median time to progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or new effusions.|Up to 2 years||||months||95% Confidence Interval|Median
2825991|NCT00331552|Secondary|Treatment-related Toxicity (Phase I)|Count of phase I participants with treatment related toxicity.|Up to 24 weeks||||Participants|||Count of Participants
2825992|NCT00331552|Primary|Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation|Count of participants with grade 1, 2, 3, 4, fatal toxicity, need for dose reduction, treatment interruption, or treatment discontinuation|Periodically during study treatment, up to 24 weeks||||Participants|||Count of Participants
2825993|NCT00331552|Primary|Efficacy as Assessed by the Overall Clinical Benefit Rate|Count of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).|18 months||||Participants|||Count of Participants
2825994|NCT00331552|Primary|Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)|The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment|Up to 24 weeks||||mg/m^2|||Number
2825995|NCT00331422|Secondary|Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy|"Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked.~Unable to evaluate; patients did not consistently complete the questionnaires."|Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)|||||||
2825996|NCT00331422|Secondary|Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density|Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.|Week 18 (At surgery)|||||||
2825997|NCT00331422|Secondary|Change in Drug Resistance After Neoadjuvant Chemotherapy|As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.|Day 1 to Time to Surgery (Approximately Week 18)|||||||
2826000|NCT00331422|Primary|Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy|These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.|Week 18 (After 4 cycles of chemotherapy)|Includes those patients that received 4 cycles of therapy before removal of cancerous tissue. Evaluation of overall response is not possible due to low number of patients and therefore could not obtain statistical significance.|||Participants|||Number
2826001|NCT00331409|Secondary|Number of Participants With Adverse Events|"Toxicity assessments will be obtained as follows:~Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles~Safety assessments will consist of evaluating adverse events and serious adverse events."|Duration of study, Up to 4 years||||participants|||Number
2826002|NCT00331409|Secondary|Number of Subjects That Demonstrated a Reduction in Tumor Measurements.|Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|Up to 4 years|2 subjects were not evaluable. Reduction in target lesion sum did not meet the criteria for Partial Response (PR) for any of the subjects. Partial Response, per RECIST, includes at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|||Participants|||Count of Participants
2826003|NCT00331409|Secondary|Median Time to Progression||Time to progression||||months||95% Confidence Interval|Median
2826004|NCT00331409|Primary|Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months||Up to 4 years||||participants|||Number
2826005|NCT00331409|Primary|Progression-free Survival at 3 Months||3 months post 1st dose||||months||95% Confidence Interval|Median
2826006|NCT00331344|Secondary|Time to Progression (Phase II)|Measured from the start of protocol therapy until RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.0 progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 3 months until cancer progression/excessive toxicity or death||||months||95% Confidence Interval|Median
2826007|NCT00331344|Primary|Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I).|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the maximum tolerated dose (MTD). If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m^2. Toxicities will be tabulated by grade for each dose cohort and overall for all patients accrued to the phase I study.|Course 1 (first 21 days)|Dose escalation safety study (Phase I)|||Participants|||Count of Participants
2826008|NCT00331344|Primary|Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I)|This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The cumulative grade 3 or higher adverse events for all dose levels are noted below and in the table of adverse events.|Every 21 days until cancer progression/excessive toxicity or death|Phase I dose escalation study participants|||Adverse Events (above threshold)|||Number
2826009|NCT00331344|Primary|Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II)|"Descriptive statistics will be calculated to characterize the disease and treatment factors including the proportion responding with a 95% confidence interval. If accrual is completed and more than 15 of 58 patients show > 50% Prostate Specific Antigen (PSA) declines after 3 courses, then the null hypothesis of a 20% response proportion will be rejected. PSA declines for individual patients will be plotted in the form of a waterfall diagram of maximal PSA declines.~58 patients were enrolled for phase II, two were ineligible so 56 patients were analyzed."|Every 3 courses until cancer progression/excessive toxicity or death||||Participants|||Count of Participants
2826010|NCT00331162|Secondary|Health Status and Quality of Life||2 years|No data was collected.||||||
2826011|NCT00331162|Secondary|Cost||2 years|No data was collected||||||
2826012|NCT00331162|Secondary|Other Adverse Events|Number of patients with other adverse events (posttransplant lymphoproliferative disorder (PTLD), and nonskin malignancy), were reported.|2 years||||Participants|||Count of Participants
2826013|NCT00331162|Secondary|Infectious Adverse Events|Number of events for infectious adverse events were reported (Polyoma virus nephropathy (PVD), cytomegalovirus (CMV), bacterial and fungal infections).|2 years||||number of events|||Number
2826014|NCT00331162|Secondary|Hematologic Adverse Events||2 years|No data was collected||||||
2826015|NCT00331162|Primary|Acute Rejection|The number of patients with acute rejection after transplantation was reported.|5 years||||Participants|||Count of Participants
2826016|NCT00331162|Primary|Graft Survival|The number of patients with graft survival after kidney alone, simultaneous pancreas-kidney (SPK), and pancreas after kidney (PAK) transplant.|5 years|Number the analyzed in one or more rows differs from overall number analyzed because there were subgroups for transplantation.|||Participants|||Count of Participants
2826017|NCT00331162|Primary|Patient Survival|The number of patients that survived after transplantation occurred was reported.|5 years||||Participants|||Count of Participants
2826018|NCT00331006|Secondary|Proportion of Rituximab Infusions in Which a Reaction to the Infusion Was Reported|Proportion of rituximab infusions in which a reaction to the infusion was reported|Measured at Week 1 through Week 4|All rituximab infusions given to study participants|||proportion of rituximab infusions|Participants|95% Confidence Interval|Number
2826054|NCT00330733|Secondary|Plasma sVCAM|Plasma soluble VCAM was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.|8 and 12 weeks|Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication|||ng/ml||95% Confidence Interval|Median
2826019|NCT00331006|Secondary|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
2826020|NCT00331006|Secondary|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
2826021|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
2826022|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Meeting the Criteria of a Serious Adverse Event|Median number of bleeding events per subject meeting the criteria of a serious adverse event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.|||participants||Inter-Quartile Range|Median
2826023|NCT00331006|Secondary|Percent Change in Inhibitor Titer on Challenge With Factor VIII From Baseline Challenge to Post-treatment Challenge|percent change=100%*(A-B)/B where A=inhibitor titer measured within 5-7 days following FVIII rechallenge and B=inhibitor titer measured within 5-14 days following baseline FVIII challenge. A FVIII rechallenge was performed within 10-18 days of the first monthly study visit in which an inhibitor titer result <5 BU/mL was obtained beginning 2 weeks and continuing through 18 weeks following the last rituximab infusion.|Measured within approximately 22 weeks|All subjects who received a post-treatment rechallenge and had at least a minor response.|||percentage change||Inter-Quartile Range|Median
2826024|NCT00331006|Secondary|Proportion of Subjects With at Least Minor Response, i.e. Inhibitor Level Falls to <5 BU/mL Between Weeks 6-22 and Either Remains <5 BU/mL 5-7 Days Following FVIII Rechallenge or Titer Following FVIII Rechallenge is 5-10 BU/mL & <50% of Original Peak|Presence or absence of at least a minor response in each participant|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab|||proportion of participants||95% Confidence Interval|Number
2826025|NCT00331006|Primary|Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following Re-challenge With FVIII|Presence or absence of a major response in each participant. Major response is defined as occurring when inhibitor level falls to less than 5 BU/mL between Weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with FVIII|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab|||proportion of participants||95% Confidence Interval|Number
2826026|NCT00330967|Primary|JNK MAPK Expression With Femoral Lipid and Insulin Infusions|JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826027|NCT00330967|Primary|Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826028|NCT00330967|Primary|ERK MAPK Expression With Femoral Lipid and Insulin Infusions|ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826029|NCT00330967|Primary|Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826030|NCT00330967|Primary|p38 MAPK Expression With Femoral Lipid and Insulin Infusions|p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826031|NCT00330967|Primary|Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826032|NCT00330967|Primary|Insulin Signaling With Lipid Infusion|IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.|4 h||||ratio||Standard Deviation|Mean
2826033|NCT00330928|Secondary|Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.|1 year|||||||
2826034|NCT00330928|Secondary|Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.|Baseline to 7 day|All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.|||participants|||Number
2826035|NCT00330928|Secondary|Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics||Baseline|||||||
2826036|NCT00330928|Secondary|Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes|This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.|Baseline|||||||
2826037|NCT00330928|Primary|Spectral Similarity|Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was >=67%, on a continuous range of 0%(different) to 100%(identical) similarity.|Baseline|58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if >80% of the NIRS data for a subject was similar to the autopsy NIRS set.|||percent similarity||95% Confidence Interval|Mean
2826038|NCT00330915|Secondary|Number of Participants Receiving Sphincter Saving Surgery||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.|||participants|||Number
2826039|NCT00330915|Secondary|Number of Participants With Complete Tumor Resection||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.|||participants|||Number
2826040|NCT00330915|Secondary|Pathological Complete Response (pCR)|Pathological complete response was defined as the absence of any tumor cells.|surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.|||participants|||Number
2826041|NCT00330915|Primary|Feasibility of Pemetrexed Prior to Surgery|Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.|3 cycles (21-day cycles)|Number of participants enrolled.|||participants|||Number
2826042|NCT00330876|Secondary|Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol (TC)|Baseline to 60 weeks|Subjects with a measurement at Week 60|||percent change||Standard Deviation|Mean
2826043|NCT00330876|Primary|Change From Baseline in LDL-C|percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|Baseline to 60 weeks|Subjects with measurement at Week 60|||percent change||Standard Deviation|Mean
2826044|NCT00330863|Secondary|Side Effects and Metabolic Measures|The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse.|Measured throughout study up to 30 months||||units on a scale||Standard Deviation|Mean
2826045|NCT00330863|Secondary|Quality of Life Measures|Scale of Functioning (SOF)|Measured throughout study up to 30 months|No data displayed because Outcome Measure has zero total participants analyzed. Data not collected.||||||
2826046|NCT00330863|Secondary|Control of Psychiatric Symptoms|Brief Psychiatric Rating Scale (BPRS) total score|Measured throughout study up to 30 months|These data were not collected. No data displayed because Outcome Measure has zero total participants analyzed.||||||
2826047|NCT00330863|Secondary|Number of Days in Hospital||Measured throughout study up to 30 months|These data were not collected.||||||
2826048|NCT00330863|Secondary|Number of Patients Discontinuing From the Study||Measured throughout study up to 30 months||||participants|||Number
2826049|NCT00330863|Primary|Substantial Clinical Deterioration Measured by Psychotic Symptoms|Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.|Measured throughout study up to 30 months|We conducted a mixed model regression analysis with two treatment groups X time psychosis cluster scores at each 3 monthly observation from baseline to 30 months. Missing data were treated as MAR|||units on a scale||95% Confidence Interval|Least Squares Mean
2826050|NCT00330759|Secondary|Time to the First-and-Subsequent On-Study Skeletal-Related Event|"Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.~This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|up to 33 months|Full Analysis Set, composed of all randomized participants|||Events|||Number
2826051|NCT00330759|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.|||Days||95% Confidence Interval|Median
2826052|NCT00330759|Primary|Time to the First On-Study Skeletal-Related Event (Non-Inferiority)|Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.|||Days||95% Confidence Interval|Median
2826053|NCT00330733|Secondary|Plasma Adiponectin|Plasma soluble Adiponectin was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.|8 and 12 weeks|Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication|||μg/ml||95% Confidence Interval|Median
2826057|NCT00330733|Secondary|Plasma CRP|Plasma C-reactive protein was measured by PVAHS clinical laboratory. Data are reported as change from baseline at 8 and 12 weeks.|8 and 12 weeks|Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication|||mg/l||95% Confidence Interval|Median
2826058|NCT00330733|Secondary|Glucose Area Under the Curve in These Subjects||3 months|analysis was performed on all participants with available baseline and final clamp studies|||mmol/l/hr||Standard Deviation|Mean
2826059|NCT00330733|Primary|Change in Systemic Glucose Disposal- Glucose Infusion Rates|Participants were admitted to the Clinical Research Units at 06:00-08:00 hours after an overnight fast. Euglycaemic-hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm−2 min−1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.|3 months|analysis was performed on all participants with available baseline and final clamp studies|||percent change from baseline||95% Confidence Interval|Median
2826060|NCT00330681|Secondary|Percentage of Participants With Abnormal Changes in Sensory Examinations||24 weeks||||percentage of participants|||Number
2826061|NCT00330681|Secondary|Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group||24 weeks|"1 patient with missing data was excluded from the FAS in the Placebo of MCI-186 group."|||percentage of participants|||Number
2826062|NCT00330681|Secondary|Percentage of Participants With Adverse Drug Reactions||24 weeks||||percentage of participants|||Number
2826063|NCT00330681|Secondary|Percentage of Participants With Adverse Events||24 weeks||||percentage of participants|||Number
2826064|NCT00330681|Secondary|Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks|The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40|baseline and 24 weeks|"1 patient with diseases other than ALS, 1 patient who did not reach the end of cycle 3 and 5 patients with missing data were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 and 4 patients with missing data were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
2826065|NCT00330681|Secondary|Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks|The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102|baseline and 24 weeks|"1 patient with diseases other than ALS, 1 patient who did not reach the end of cycle 3 and 5 patients with missing data were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 and 2 patients with missing data were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
2826066|NCT00330681|Secondary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks||baseline and 24 weeks|"1 patient with diseases other than ALS and 1 patient who did not reach the end of cycle 3 were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."|||percentage of FVC||Standard Error|Least Squares Mean
2826067|NCT00330681|Secondary|Death or a Specified State of Disease Progression|"Any of death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding was defined as an event."|24 weeks|"1 patient with diseases other than ALS was excluded from the FAS in the MCI-186 group."|||participants|||Number
2826068|NCT00330681|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|ALSFRS-R Score: 0=worst; 48=best|baseline and 24 weeks|"1 patient with diseases other than ALS and 1 patient who did not reach the end of cycle 3 were excluded from the FAS in the MCI-186 group.~5 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
2826069|NCT00330668|Secondary|Height SD Score||during the course of the study||||SD score||Standard Deviation|Mean
2826070|NCT00330668|Secondary|Height Velocity Standard Deviation (SD) Score||during the course of the study||||SD score||Standard Deviation|Mean
2826071|NCT00330668|Secondary|Height Velocities During Subsequent Years of rh IGF-1 Treatment|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after 2, 3 and 5 years of treatment||||cm/year||Standard Deviation|Mean
2826072|NCT00330668|Primary|Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after one year of treatment||||cm/year||Standard Deviation|Mean
2826073|NCT00330616|Secondary|Serious Adverse Events||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.|||Participants|||Number
2826074|NCT00330616|Secondary|Adverse Events (>=5% Incidence)||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.|||Participants|||Number
2826075|NCT00330616|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8|The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
2829322|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 48|Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive HBeAg at Baseline. Non-Completers=Failure|||participants|||Number
2826076|NCT00330616|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Responders|||Number
2826077|NCT00330616|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
2826078|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
2826079|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
2826080|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
2826081|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
2826082|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Remitters|||Number
2826083|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Remitters|||Number
2826084|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Responders|||Number
2826085|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Responders|||Number
2826157|NCT00329784|Secondary|Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.|60 months|Intent-to-treat with data available|||Participants|||Count of Participants
2826086|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
2826087|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Percentage of Change||Standard Deviation|Mean
2826088|NCT00330616|Primary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.|||Scores on a scale||Standard Deviation|Mean
2826089|NCT00330564|Primary|Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL)|Safety evaluation = Number of participants with treatment terminating toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Early stopping rules applied when treatment terminating toxicity occurred in the first 6 week cycle. Recurring grade 3 toxicity requires dose reduction, with no more than 2 dose reductions permitted. If no improvement after 4 weeks, patient is taken off drug and off study, and the event recorded as treatment terminating toxicity.|12 weeks|Intent to treat once the first dose was taken.|||participants|||Number
2826090|NCT00330564|Secondary|Number of VHL Lesion Complete + Partial Responses|Response of VHL lesions (number) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): 20% increase in LD sum and Stable Disease (SD): Insufficient shrinkage to qualify for PR nor increase to qualify for PD. Degree and timing of response in affected organs evaluated in order to determine organ specific kinetics of therapy.|Baseline to 12 months (evaluations at 6 and 12 months)|Secondary end point of efficacy showed response of renal cell carcinomas, which responded better to sunitinib therapy than other VHL related lesions using RECIST measure.|||VHL lesion|Participants||Number
2826091|NCT00330551|Secondary|Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R)|Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.|Baseline to 12 months|All participants with ratings at baseline and 12 months, with 6-month rating carried forward if no 12-month rating was completed.|||Changes on a 4-point rating scale||Standard Deviation|Mean
2826092|NCT00330551|Secondary|Retention in Treatment|Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better retention in treatment.|From baseline to 12 months|All participants randomized to oral vs. long-acting injectable risperidone|||days||Standard Deviation|Mean
2826093|NCT00330551|Secondary|Emotional Reactivity on Psychophysiological Measures|Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity.|Measured from Baseline to Month 12|No data were available because this part of the initial proposal was not funded.||||||
2826094|NCT00330551|Secondary|MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score|The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome.|Measured at baseline and 12 months|All participants with MCCB Overall Composite scores at baseline and 12 months|||Changes in T scores||Standard Deviation|Mean
2826095|NCT00330551|Primary|Global Functioning Scale: Role|Change on a 10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months.|Measured from Baseline to Month 12|All participants with Global Functioning Scale: Role ratings at baseline and 12 months|||Changes on a 10-point scale||Standard Deviation|Mean
2826096|NCT00330551|Primary|Maintenance of Work/School Attendance (SAS)|Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks.|Measured from Baseline to Month 12|All participants with data on duration of work or school|||weeks||Standard Deviation|Mean
2826097|NCT00330551|Primary|Return to Work or School (SAS Work Section)|The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment.|Measured from Baseline to Month 12|All participants with data regarding return to work or school|||Participants|||Count of Participants
2826171|NCT00329719|Secondary|Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement|The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.|Up to 5 years||||proportion of patients||90% Confidence Interval|Number
2826098|NCT00330551|Primary|Exacerbation or Relapse of Psychotic Symptoms|Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.).|Occurrence after randomization and until end of study participation (up to 12 mos.)|All participants randomized to long-acting injectable or oral risperidone|||Participants|||Count of Participants
2826099|NCT00330551|Primary|Medication Adherence|5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation|Averaged over study participation (up to 12 months)||||units on a scale||Standard Deviation|Mean
2826100|NCT00330460|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2826101|NCT00330460|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2826102|NCT00330460|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2826103|NCT00330460|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2826104|NCT00330460|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Randomized subjects who have a nonmissing baseline and at least 1 nonmissing postbaseline evaluation at or prior to month 12. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2826105|NCT00330421|Primary|Incidence of Adverse Events||Up to 1 month|||||||
2826106|NCT00330421|Primary|Clinical Benefit, Measured by Any Reduction in Tumor Dimensions on CT Scan as Measured by RECIST Criteria||Up to 1 month|||||||
2826107|NCT00330421|Primary|Clinical Benefit as Measured by 50% Reduction in IFP||Baseline to surgery|||||||
2826108|NCT00330421|Primary|Change in Pericyte Coverage of Endothelial Cells (Alpha-SMA)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|||||||
2826109|NCT00330421|Primary|Change in White Blood Cell Count (WBC)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|||||||
2826110|NCT00330421|Primary|Change in Interstitial Fluid Pressure (IFP)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.|||mm Hg||Full Range|Mean
2826111|NCT00330421|Primary|Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|||||||
2826112|NCT00330382|Secondary|Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months||Baseline to 6 months|The participants whose data are available and complete are included in the analysis.|||percentage change||95% Confidence Interval|Median
2826113|NCT00330382|Secondary|Number of Participants Report at Least 1 Adverse Event During the Study|The onset of adverse event is between the randomizaiton date and off-study date|Randomized date to Off-study date, up to 21 months||||participants|||Number
2826114|NCT00330382|Secondary|Relative Percent Change in Protease Activity (Delta RFU/Min/µg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||95% Confidence Interval|Median
2826115|NCT00330382|Secondary|Relative Percent Change in Serum Neu Protein (ng/ml)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||95% Confidence Interval|Median
2826116|NCT00330382|Secondary|Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||95% Confidence Interval|Median
2826117|NCT00330382|Secondary|Clinical Impression From Photographs|"A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, top photo shows a complete response relative to the bottom photo, through, the same degree of disease is shown by top photo and bottom photo, to bottom photo shows a complete response relative to the top photo. Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo."|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.|||score||Standard Deviation|Mean
2826118|NCT00330382|Primary|Number of Participants by Category of Clinical Response at 6 Months|Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease.|6 months|The participants who have complete data are analyzed in this outcome measure.|||participants|||Number
2826119|NCT00330382|Secondary|The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen|The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period.|Baselie to 6 months|The participants who have complete data are analyzed in this outcome measure.|||score||Standard Deviation|Mean
2826120|NCT00330382|Primary|Relative Percent Change in Total Lesion Area After 6 Months on Study|Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.|6 months|The participants who have complete data are analyzed in this outcome measure.|||percentage change||Standard Deviation|Mean
2826121|NCT00330343|Primary|Number of Participants With Naloxone Side Effects|incidence of nausea, vomiting, pruritus following naloxone infusion|0-48 hours after infusion begins||||participants||95% Confidence Interval|Number
2826122|NCT00330187|Primary|Biologically-verified 7-day Point Prevalence Smoking Abstinence|Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL|End of treatment (week 6)|Intent-to-treat analysis|||participants|||Number
2826123|NCT00330174|Secondary|Hospital Anxiety and Depression Scale|This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.|12 weeks||||units on a scale||Standard Error|Mean
2826124|NCT00330174|Secondary|Liebowitz Social Anxiety Scale|The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.|12 weeks||||units on a scale||Standard Error|Mean
2826125|NCT00330174|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.|12 weeks||||units on a scale||Standard Error|Mean
2826126|NCT00330174|Primary|Percent Days Drinking|Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.|12 weeks|The primary outcome measure is difference in cumulative days abstinent. Based on the meta-analysis by Mann et al (2004). A total sample of 90 participants would be able to detect a difference of 11 (+/- 18) days between acamprosate and placebo groups with 80% power, and Type 1 error rate of 0.05.|||percentage of days drinking||Standard Error|Mean
2826127|NCT00330161|Secondary|Objective Response Rate|Percentage of participants that obtain the best objective response, stable disease.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.|||percentage of participants|||Number
2826128|NCT00330161|Secondary|Median Survival|Median overall survival.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis. Of the 27 patients analyzed, one patient was censored with an outlying overall survival of 15.1 months.|||months||Full Range|Median
2826129|NCT00330161|Secondary|Progression-free Survival|Median time to progression was determined.|From the start of treatment to time of progression, assessed up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.|||months||Full Range|Median
2826130|NCT00330161|Secondary|Rate of PSA Decline|Rate of Prostate Specific Antigen (PSA) decline of greater than or equal to 50%.|Up to 3 years|No PSA declines of greater than or equal to 50% were observed, therefore the rate could not be determined.||||||
2826131|NCT00330161|Secondary|Incidence of Toxicity|The percentage of eligible participants that experience grade 3 or 4 toxicities.|Up to 3 years|Of the 29 patients enrolled, 2 were deemed ineligible after treatment and therefore excluded from outcome analysis.|||percentage of participants|||Number
2826132|NCT00330161|Primary|Proportion of Patients Who do Not Demonstrate Disease Progression|Fisher's Exact Test will be used.|At 6 months|The primary objective was to determine the number of patients wtih progression-free survival at 6 months. Unfortunately all eligible patients were off therapy before the 6 month time point. 13 (48%) were removed due to progression, 11 (41%) secondary to toxicity, and 3 (11%) for other reasons.||||||
2826133|NCT00329901|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo|The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.|Throughout the study (Day 1 to Day 181)|This analysis was done on the safety population.|||Participants|||Number
2826134|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo|Day 1-7 after any vaccination|Analysis was done on the safety population|||Participants|||Number
2826135|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.|Day 1-7 after any vaccination|Analysis was done on the safety population|||Participants|||Number
2826136|NCT00329901|Secondary|Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.~Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2826137|NCT00329901|Secondary|Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Ratios||95% Confidence Interval|Geometric Mean
2826138|NCT00329901|Secondary|The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2826139|NCT00329901|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.~The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA)."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2826140|NCT00329901|Secondary|Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2826141|NCT00329901|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
2826142|NCT00329901|Secondary|Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2826143|NCT00329901|Primary|Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|"To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of~the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and~the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA)."|1 month after vaccination (Day 29)|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding|||Percentages of subjects||95% Confidence Interval|Number
2826144|NCT00329849|Secondary|Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS|Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 to 7 postvaccination|Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age.|||participants|||Number
2826145|NCT00329849|Secondary|The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS|Day 181|Analysis was performed on the PP dataset for persistence analysis at day 181.|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
2826172|NCT00329719|Secondary|Overall Survival|The overall survival distribution will be estimated using the method of Kaplan-Meier.|From start of study registration to death due to any cause or until last follow-up, up to 5 years||||months||95% Confidence Interval|Median
2826146|NCT00329849|Secondary|Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 181|Analysis was performed on PP dataset for persistence analysis at day 181.|||Percentage of subjects||95% Confidence Interval|Number
2826147|NCT00329849|Secondary|The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.|||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
2826148|NCT00329849|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.|||Percentage of subjects||95% Confidence Interval|Number
2826149|NCT00329849|Primary|Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination|Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.|Day 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2826150|NCT00329849|Primary|Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine.~Seroresponse was defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8;~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|1 month after vaccination (day 29)|Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.|||Percentage of subjects||95% Confidence Interval|Number
2826151|NCT00329836|Primary|Prevalence of Allodynia in Subjects With Cluster Headache|Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.|Allodynia was assessed at the screening visit|N/A. No lost to follow-up or missing data. All enrolled subjects were analyzed|||participants|||Number
2826152|NCT00329797|Secondary|Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival|The EQ-5D is a standardized instrument for measuring generic health status used to generate health utilities, used to derive quality adjusted survival. Quality adjusted survival is computed using the weighted sum of times in different health states added up to a total quality-adjusted survival time. The log-rank test is used to compare quality-adjusted survivals between the treatment arms.|From pre-treatment to 3 years from start of treatment|Eligible patients with baseline and follow-up EQ-5D scores, resulting in only 59 patients (no deaths), less than half of enrolled patients (and less than 5% of planned enrollment), which is extremely problematic as it can lead to selection bias, especially with even fewer patients with follow-up scores. Therefore analysis was not conducted.||||||
2826153|NCT00329797|Secondary|Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years|The FACT-G is a validated, 27-item measure. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for the physical, social and functional subscales, and 0-24 for the emotional subscale. Certain items, identified on the FACT-G scoring guides, must be reversed before it is added by subtracting the response from 4. All subscale totals are added together to form the FACT-G total score. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL.|Baseline, 3 years from start of treatment|Eligible patients with baseline and 3-year FACT-G data|||units on a scale||Full Range|Mean
2826154|NCT00329797|Secondary|Percent Change in Bone Mineral Density at 3 Years|Bone mineral density (BMD) was measured by DXA scan (Dual X-ray absorptiometry) for five locations: lumbar, right total hip, left total hip, right femoral neck, and left femoral neck. The percent change at 3 years was calculated for each location by the following formula: Percent Change BMD = (BMD_3 years - BMD_Baseline)/ BMD_Baseline * 100.|Baseline, 3 years from start of treatment|Eligible patients with baseline and 3-year BMD data at respective location|||percentage of baseline value||Full Range|Mean
2826155|NCT00329797|Primary|Freedom From Any Bone Fracture (FABF) Rate at Three Years|The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone. The three-year FABF rate will be estimated by the Kaplan-Meier method.|From randomization to 3 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2826156|NCT00329784|Secondary|Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.|60 months|Intent-to-treat with data available|||Participants|||Count of Participants
2826707|NCT00328172|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks|An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.|Baseline, week 12|FAS patients with baseline HbA1c > 7.0%. Non-completers were considered as failure imputation (NCF).|||participants|||Number
2826158|NCT00329784|Secondary|Number of Participants With Rhinitis at 60 Months|At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).|60 months|Intent-to-treat with rhinitis data available|||Participants|||Count of Participants
2826159|NCT00329784|Secondary|Number of Participants With Asthma at 60 Months|At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.|60 months|Intent-to-treat with asthma data available|||Participants|||Count of Participants
2826160|NCT00329784|Secondary|SCORAD at 60 Months|At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child's eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.|60 months|Intent-to-treat with SCORAD data available|||units on a scale||Standard Deviation|Mean
2826161|NCT00329784|Primary|Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat – all randomly assigned participants who were evaluable for peanut allergy at age 60 months|||Participants|||Count of Participants
2826162|NCT00329784|Primary|Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat – all randomly assigned participants who were evaluable for peanut allergy at age 60 months|||Participants|||Count of Participants
2826163|NCT00329771|Primary|Proportion of Subjects With Allodynia During a Migraine Attack|Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS).|allodynia assessed within 4 hours from onset of migraine head pain|Participants who completed allodynia test|||participants|||Number
2826164|NCT00329745|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the end of the primary study up to Year 3||||subjects|||Number
2826165|NCT00329745|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|"Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample.~Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary."|From Year 2 up to Year 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy.|||subjects|||Number
2826166|NCT00329732|Secondary|Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes|||||||
2826167|NCT00329732|Secondary|Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.||30 minutes|||||||
2826168|NCT00329732|Secondary|Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes|||||||
2826169|NCT00329732|Primary|Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.||30 minutes|No analysis was done. Study was terminated.||||||
2826170|NCT00329719|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to estimate progression-time distributions.|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years||||months||95% Confidence Interval|Median
2826173|NCT00329719|Primary|Progression-free Survival|"The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation.~If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group.~The 'success' probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the 'success' probability will be calculated according to the approach of Duffy and Santner.~Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|At 6 months||||Proportion of Successes||95% Confidence Interval|Number
2826174|NCT00329641|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)|Eligible patients who started therapy|||Participants with a given type of AE|||Number
2826175|NCT00329641|Secondary|6-month Progression-free Survival|Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact|Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death||||Percent of population||95% Confidence Interval|Number
2826176|NCT00329641|Secondary|One-year Overall Survival|Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact|Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death|Eligible patients who received some treatment|||Percentage of population||95% Confidence Interval|Number
2826177|NCT00329641|Primary|Response Rate (Complete and Partial Response)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression|Eligible patients who received some treatment|||participants|||Number
2826178|NCT00329602|Post-Hoc|Post-hoc Analysis of Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 12 and 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of CGI-I, exploring the variation in treatment effects across center groups by excluding the same two center groups as in the IRLS post-hoc analysis, was conducted. Centers were grouped into five center groups.|Weeks 12 and 26|ITT Population excluding the same two center groups as in the IRLS post-hoc analysis. Analysis is based on the observed cases for each visit.|||Number of responders|||Number
2826179|NCT00329602|Post-Hoc|Post-hoc Analysis of Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of the primary outcome measure, exploring the variation in treatment effects across center groups by excluding those with the most extreme treatment effects, was conducted. Centers were grouped into five center groups.|Baseline and Weeks 12 and 26|ITT Population excluding the two center groups with the most extreme treatment effects. Analysis is based on the observed cases for each visit.|||Points on a scale||Standard Error|Least Squares Mean
2826180|NCT00329602|Secondary|Mean Change From Baseline in the IRLS Rating Scale Total Score at Week 67|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4, with 0 representing the absence of a problem and 4 reflecting a very severe problem. The best and worst possible scores are 0 and 40, respectively. The primary assessment was made by calculating the difference in the average score obtained at Baseline with score at Week 67.|Baseline and Week 67|Open-Label ITT Population: all participants who were enrolled into the Open-Label Phase of the study, received at least one dose of Open-Label study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Deviation|Mean
2826181|NCT00329602|Primary|Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases|Clinically meaningful augmentation and early morning rebound (EMR) were assessed and confirmed by an independent Adjudication Board. EMR describes the development of RLS symptoms during the early morning, following therapeutic intervention. EMR is differentiated from augmentation, in which the earlier onset of symptoms occurs in the evening.|During 15-month study duration at scheduled (Weeks 16, 20, 26, or early withdrawal for DB phase; Weeks 39, 47, 55, 63, 67, or early withdrawal for the OL phase) and unscheduled (26-week DB phase and 40-week OL phase) visits|Safety Population: all participants who received at least one dose of study medication|||participants|||Number
2826182|NCT00329602|Secondary|Number of Participants With a Score of Much/Very Much Improved on the CGI-I Scale at Week 67|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Week 67|Open-Label (OL) ITT Population: all participants who were enrolled into the OL Phase of the study, received at least one dose of OL study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Data are presented for participants still in the study and assessed at Week 26, which is less than those randomized at baseline.|||participants|||Number
2826208|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826183|NCT00329602|Secondary|Median Time to First CGI-I Response of Much/Very Much Improved During the Double-blind Phase|The median time to first CGI-I response of much/very much improved was calculated. The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available|||days||95% Confidence Interval|Median
2826184|NCT00329602|Secondary|Number of Participants Rated as Normal or Borderline Ill on the CGI Severity of Illness (CGI-S) Scale at Week 26|The CGI-S scale is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-S allows the investigator to rate the severity of the participant's illness considering their total clinical experience with the subject population being studied and on all information available at the time of rating. The scale is rated from 1-7 (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severly ill; 7 = among the most extremely ill participants).|Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Data are presented for the participants still in the study and assessed at Week 26, which is less than those randomised at baseline.|||participants|||Number
2826185|NCT00329602|Secondary|Number of Participants Withdrawing Due to Lack of Efficacy During the First 26 Weeks of the Study|Lack of efficacy is defined as up to a 10% improvement in the IRLS Rating Scale total score from the participant's Baseline value and at least 12 weeks of treatment during the double-blind phase.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available|||participants|||Number
2826186|NCT00329602|Secondary|Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 1, 12 and 26|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Weeks 1, 12 and 26|Intention-to-Treat (ITT) Population. Analysis is based on the observed cases for each visit.|||percentage of participants|||Number
2826187|NCT00329602|Secondary|Change From Baseline in the Domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26|The MOS SF-36 is a generic QoL instrument measuring functional status and well-being. Positive change from baseline for all domains indicates improvement. For all MOS SF-36 domains, the minimum and maximum scores are 0 and 100, respectively, for the transformed scale. Scores were adjusted for baseline domain score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
2826188|NCT00329602|Secondary|Change From Baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire Overall Life Impact Score at Weeks 12 and 26|The Johns Hopkins RLS QoL Questionnaire is a disease-specific instrument that assesses the impact of RLS on the daily life, emotional well-being, social life, and work life of participants. The overall life impact score for the John Hopkins RLS QoL scale ranges from a lowest possible score of 0 to a highest possible score of 100. Higher scores represent better quality of life. Scores were adjusted for baseline RLS Quality of Life score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
2826189|NCT00329602|Secondary|Change From Baseline in Sleep Quantity, a Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale, at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population.Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||hours||Standard Error|Least Squares Mean
2826190|NCT00329602|Secondary|Change From Baseline in the Domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population. Domain values are presented on a 0-100 scale, where a higher score means a greater degree of the attribute implied by the scale name. Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
2826209|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 26||Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826191|NCT00329602|Secondary|Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20|A 10-item, participant-reported scale covering different RLS symptoms. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. The primary assessment from this study was made by calculating the difference in the average score obtained at Baseline with scores at Weeks 1, 4, 8, 16, and 20. Scores were adjusted for baseline IRLS total score, treatment group, visit, visit by treatment group interaction, and center group.|Baseline and Weeks 1, 4, 8, 16, and 20|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
2826192|NCT00329602|Primary|Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. A negative change from baseline indicates improvement, and a negative treatment difference indicates a benefit of Ropinirole IR over placebo. The primary assessment was made by calculating the difference in the average score obtained at Baseline with scores at Week 12 and then Week 26.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.|||points on a scale||Standard Error|Least Squares Mean
2826193|NCT00329550|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:~an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,~use of rescue therapy, or,~subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here.|||subjects|||Number
2826194|NCT00329550|Secondary|Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826195|NCT00329550|Secondary|Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826196|NCT00329550|Secondary|Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826197|NCT00329550|Secondary|Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826210|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826198|NCT00329550|Secondary|Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826199|NCT00329550|Secondary|Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826200|NCT00329550|Secondary|Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826201|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0||Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826202|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0||Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826203|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0||Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826204|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0||Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826205|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0||Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826206|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0||Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826207|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0||Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||ratio||Full Range|Geometric Mean
2827046|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2826211|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826212|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826213|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826214|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||mg/L||Full Range|Geometric Mean
2826215|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826216|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826217|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826218|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826219|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826220|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2827047|NCT00325130|Secondary|Acceptable Safety Profile||15 days post injection|||||||
2826221|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826222|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
2826223|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826224|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826225|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826226|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826227|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826228|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826298|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826229|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
2826230|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826231|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826232|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826233|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826234|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826235|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826236|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
2826299|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826237|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826238|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826239|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826240|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826241|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826242|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826243|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
2826244|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826312|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826245|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826246|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826247|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826248|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826249|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826250|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
2826251|NCT00329550|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:~time to an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,~time to use of rescue therapy, or,~time to subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.||||||
2826252|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826253|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 26|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826254|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 24|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826255|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 20|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826256|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 16|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826257|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 12|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826258|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 8|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826259|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826260|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826261|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826497|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|36 months|FAS|||Participants|||Number
2826262|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826263|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826264|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826265|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826266|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826267|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826268|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826269|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826498|NCT00329160|Secondary|Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points||Baseline - 76Weeks||||Percent change||Standard Deviation|Mean
2826270|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826271|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8|CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].|||score on a scale||Standard Deviation|Mean
2826272|NCT00329550|Primary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.|||Percentage of subjects|||Number
2826273|NCT00329524|Secondary|Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx|Rating of tinnitus loudness using a scale of 0-100 for|immediately following active and sham TMS||||analog rating||Standard Deviation|Mean
2826274|NCT00329524|Secondary|Psychomotor Vigilance|Change in simple auditory reaction time after treatment|Immediately after treatment|per protocol|||milliseconds||Standard Deviation|Mean
2826275|NCT00329524|Primary|Change in PET Asymmetry Index|Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx|After active treatment week||||ratio||Standard Deviation|Mean
2826276|NCT00329433|Secondary|The Incidence of Bleeding in Each Group.||Up to 30 days after surgery|Intention to treat.|||Participants|||Count of Participants
2826277|NCT00329433|Secondary|The Incidence of DVTs in Each Group.||7 days after surgery|61 in Desirudin group and 59 in heparin group.|||Participants|||Count of Participants
2826278|NCT00329433|Primary|The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.|Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.|30 days after surgery|Intent-to-treat analysis was performed according to initial group assignment.|||participants|||Number
2826279|NCT00329420|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:~an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,~use of rescue therapy, or,~subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here|||subjects|||Number
2826280|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826281|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826282|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826283|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826284|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826285|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826286|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826287|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826288|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826313|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826289|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826290|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8|70-point responders are subjects achieving a reduction in Crohn's Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."|||percentage of subjects|||Number
2826291|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826292|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826293|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826294|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826295|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826296|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826297|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826499|NCT00329160|Secondary|Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）||Baseline - 76Weeks||||Percent change||Standard Deviation|Mean
2826300|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826301|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||ratio||Full Range|Geometric Mean
2826302|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826303|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 34||Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826304|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 32||Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826305|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 28||Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826306|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826307|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826308|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826309|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 14||Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826310|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826311|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 10||Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||mg/L||Full Range|Geometric Mean
2826314|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826315|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826316|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826317|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826318|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826319|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826320|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826321|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826322|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826323|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826324|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826325|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826326|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826327|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826328|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826329|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826330|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826424|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 8 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826331|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826332|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826333|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826334|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826335|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826336|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826337|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826338|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826425|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 6 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826339|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826340|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826341|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826342|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826343|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826344|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826345|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826346|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826356|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826347|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826348|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826349|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826350|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826351|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826352|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826353|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826354|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826355|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826357|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826358|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826359|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826360|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826361|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826362|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826363|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826364|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826365|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826366|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826367|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826368|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.|||score on a scale||Standard Deviation|Mean
2826369|NCT00329420|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:~time to an increase from Week 14 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,~time to use of rescue therapy, or,~time to subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented.||||||
2826370|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826371|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826372|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826373|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826374|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826375|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826376|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826377|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826378|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826379|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826380|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.|||Percentage of subjects|||Number
2826381|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826382|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826466|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Re-treatment Baseline in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826383|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826384|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826385|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826386|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826387|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826388|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826389|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826423|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 10 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826390|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.|||Percentage of subjects|||Number
2826391|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826392|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826393|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826394|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826395|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826396|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826397|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826500|NCT00329160|Secondary|Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion|Target Lesion indicates Coronary plaque composition of culprit lesions.|Baseline - 76Weeks||||mg/dL||Standard Deviation|Mean
2826398|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826399|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826400|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826401|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.|||score on a scale||Standard Deviation|Mean
2826402|NCT00329420|Primary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study.|||Percentage of subjects|||Number
2826403|NCT00329407|Secondary|Phonetic Portion of the Controlled Word Association Test (COWAT)|Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores|Baseline compared to Week 10||||Number of words||Standard Error|Mean
2826404|NCT00329407|Primary|The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method|The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.|70 days|An ITT approach was used in the analysis. Least squares value for the baseline and 10 week of treatment were compared using a t test with Dunnett-Hsu adjustment. Differences between these means are presented as the result.|||Standard Drink (14 g alcohol)||Standard Error|Mean
2826405|NCT00329303|Secondary|Time to Withdrawal From the Treatment Due to Lack of Efficacy or Due to AE ('Worsening or Exacerbation of Psoriasis') During the 12 Week Re-treatment Period in This Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the 12 week re-treatment Period in this study|Intention-To-Treat (ITT) population.|||days||Inter-Quartile Range|Median
2826406|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to last re-treatment visit in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826524|NCT00328861|Secondary|Safety|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11/30/2006 - 7/31/2007||||Participants|||Number
2826407|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826408|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826409|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826410|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826411|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826412|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826413|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826414|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826415|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826416|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826417|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826418|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826419|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826420|NCT00329303|Secondary|Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|From first treatment Baseline in C87040 to re-treatment Baseline in this study|Intention-To-Treat (ITT) population.|||percent of total Body Surface Area||95% Confidence Interval|Median
2826421|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Last re-treatment visit in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826422|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 12 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826467|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 12 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826426|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 4 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826427|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 2 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826428|NCT00329303|Secondary|BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Re-treatment Baseline in this study|Intention-To-Treat (ITT) population.|||percentage of Body Surface Area||95% Confidence Interval|Median
2826429|NCT00329303|Secondary|Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 12 of re-treatment in this study|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2826430|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Last re-treatment visit in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826431|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 12 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826432|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 10 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826433|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 8 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826434|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 6 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826435|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 4 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2827898|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: III|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with Stage III disease|||percentage of participants|||Number
2826436|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 2 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826437|NCT00329303|Secondary|Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Re-treatment Baseline in this study|Intention-To-Treat (ITT) population.|||Participants|||Count of Participants
2826438|NCT00329303|Secondary|Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|12 week re-treatment Period in this study|Intention-To-Treat (ITT) population.|||weeks||95% Confidence Interval|Median
2826439|NCT00329303|Secondary|Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|12 week first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||weeks||95% Confidence Interval|Median
2826440|NCT00329303|Secondary|Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|12 week re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826441|NCT00329303|Secondary|Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|12 week first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826442|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From re-treatment Baseline in this study to Week 12 of re-treatment in this study|Intention-To-Treat (ITT) population.|||percentage of Baseline value||95% Confidence Interval|Median
2826443|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826444|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage of Baseline value||95% Confidence Interval|Median
2826445|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826468|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 10 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826446|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826447|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826448|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826449|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826450|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to re-treatment Baseline in this study|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826451|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040|Intention-To-Treat (ITT) population.|||percentage of Baseline value||95% Confidence Interval|Median
2826452|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826453|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826454|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826469|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 8 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826455|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826456|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826457|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826458|NCT00329303|Secondary|Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline."|From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040|Intention-To-Treat (ITT) population.|||percentage change||95% Confidence Interval|Median
2826459|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Last re-treatment visit in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826460|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 12 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826461|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 10 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826462|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 8 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826463|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 6 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826464|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 4 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826465|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 2 of re-treatment Period in this study|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826585|NCT00328627|Secondary|Change From Baseline to Week 8 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
2826470|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 6 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826471|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 4 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826472|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 3 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826473|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 2 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826474|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|Week 1 of first treatment Period in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826475|NCT00329303|Secondary|Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity."|First treatment Baseline in study C87040|Intention-To-Treat (ITT) population.|||units on a scale||95% Confidence Interval|Median
2826476|NCT00329303|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 90 %."|Week 12|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2826477|NCT00329303|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 90 %."|Week 12|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2826478|NCT00329303|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 50 %."|Week 12|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2826479|NCT00329303|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 50 %."|Week 12|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2826480|NCT00329303|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 75 %."|Week 12|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2826481|NCT00329303|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 75 %."|Week 12|Intention-To-Treat (ITT) population.|||percentage of subjects|||Number
2827899|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIB|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB|||percentage of participants|||Number
2826482|NCT00329303|Primary|Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study|The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'.|Week 12 in C87040 [NCT00245765] and Week 12 in this study|Intention-To-Treat (ITT) population with Last Observation Carried Forward (LOCF).|||units on a scale||95% Confidence Interval|Median
2826483|NCT00329238|Secondary|Number of Participants With Definite Acute Coronary Syndrome (ACS)|All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.|day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination|FAS as treated|||participants|||Number
2826484|NCT00329238|Secondary|Laboratory Analysis|Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).|18 months + 30 days follow up|FAS as treated|||participants|||Number
2826485|NCT00329238|Secondary|Number of Participants With Bleeding Events|"MBE (major bleeding event) if it fulfilled at least one of the following criteria~Fatal bleeding~Symptomatic bleeding in a critical area or organ.~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.~Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs~CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria~Spontaneous skin haematoma ≥25 cm2~Spontaneous nose bleed >5 min duration~Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h~Spontaneous rectal bleeding~Gingival bleeding >5 min~Bleeding leading to hospitalisation or requiring surgical treatment~Bleeding leading to a transfusion of <2 units of whole blood or red cells~Any other bleeding event considered clinically relevant by the investigator"|first intake of study drug until 6 days following last intake of study drug|FAS as treated|||participants|||Number
2826486|NCT00329238|Secondary|Deaths of All Causes at 18 Months|Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|18 months|FAS|||Participants|||Number
2826487|NCT00329238|Secondary|Deaths of All Causes at 36 Months|Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|36 months|FAS|||Participants|||Number
2826488|NCT00329238|Secondary|Deaths Related to VTE at 18 Months|Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|18 months|FAS|||Participants|||Number
2826489|NCT00329238|Secondary|Deaths Related to VTE at 36 Months|Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|36 months|FAS|||Participants|||Number
2826490|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 18 Months|Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|18 months|FAS|||Participants|||Number
2826491|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 36 Months|Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|36 months|FAS|||Participants|||Number
2826492|NCT00329238|Secondary|DVT at 18 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|18 months|FAS|||Participants|||Number
2826493|NCT00329238|Secondary|Deep Vein Thrombosis (DVT) at 36 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|36 months|FAS|||Participants|||Number
2826494|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|18 months|FAS|||Participants|||Number
2826495|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|36 months|FAS|||Participants|||Number
2826496|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|18 months|FAS|||Participants|||Number
2826501|NCT00329160|Primary|Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)|Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.|Baseline and 76 weeks||||Percent Change||Standard Deviation|Mean
2826502|NCT00329108|Secondary|Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.||6 months|||||||
2826503|NCT00329108|Secondary|Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.||6 weeks|||||||
2826504|NCT00329108|Secondary|Time to Symptomatic Remission in the Double Blind Phase.||up to 10 weeks|||||||
2826505|NCT00329108|Secondary|Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.||4, 6 and 10 weeks|||||||
2826506|NCT00329108|Secondary|Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.||6 months|||||||
2826507|NCT00329108|Secondary|Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.||up to 10 weeks|||||||
2826508|NCT00329108|Primary|Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.|YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.|4 weeks|Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||score on scale|||Number
2826509|NCT00329030|Secondary|Neutrophil Recovery|Time to neutrophil recovery will be the first of two consecutive days of > 500 neutrophils/μL following the expected nadir.|Day 28 and Day 60||||percentage of participants||95% Confidence Interval|Number
2826510|NCT00329030|Secondary|Treatment-related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
2826511|NCT00329030|Secondary|Immune Reconstitution of Quantitative Immunoglobulins|Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.|1 year||||mg/dL||Standard Deviation|Mean
2826512|NCT00329030|Secondary|Immune Reconstitution|Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.|1 year||||cells/uL||Standard Deviation|Mean
2826513|NCT00329030|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.|Day 21||||scores on a scale||Full Range|Median
2826514|NCT00329030|Secondary|Incidence of Infection||1 year|67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.|||participants|||Number
2826515|NCT00329030|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1,500 neutrophils/μL, hemoglobin > 10 g/dL without transfusion support, and platelet count > 100,000/μL without transfusion support.|100 days, 1 year||||percentage of participants||95% Confidence Interval|Number
2826516|NCT00329030|Secondary|Platelet Recovery to 20,000 Cells/μL||100 and 180 days||||percentage of participants||95% Confidence Interval|Number
2826517|NCT00329030|Secondary|Complete Response (CR) and Partial Response (PR) Proportion||Day 100 and 2 years||||percentage of participants||95% Confidence Interval|Number
2826518|NCT00329030|Secondary|Incidence of Relapse/Progression|The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
2826519|NCT00329030|Secondary|Overall Survival|The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
2826520|NCT00329030|Primary|Progression-free Survival (PFS)|Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.|1 and 2 years||||percentage of participants||95% Confidence Interval|Number
2826521|NCT00328926|Secondary|Percentage of Participants With Cumulative Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles.|Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])|ITT population included all participants who were treated to trial treatment.|||Percentage of participants|||Number
2826522|NCT00328926|Secondary|Percentage of Participants With Cumulative Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who received study treatment.|||Percentage of participants|||Number
2826523|NCT00328926|Primary|Time to Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Full Range|Median
2826525|NCT00328861|Primary|Objective Response|Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.||||Participants|||Number
2826526|NCT00328783|Secondary|Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.|To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.|30 days post-treatment||||Participants|||Count of Participants
2826527|NCT00328783|Secondary|Change in Organs at Risk (OAR) Dosimetric Paramaters|To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.|30 days post-treatment||||Gy||95% Confidence Interval|Mean
2826528|NCT00328783|Secondary|Toxicity Evaluation|Number of participants that experienced grade three toxicity or higher as a result of treatment.|30 days post-treatment||||Participants|||Count of Participants
2826529|NCT00328783|Primary|Proportion of Patients With Reduction in Radiation||30 days||||proportion of patients||95% Confidence Interval|Number
2826530|NCT00328783|Primary|Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues|"To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.~The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose."|At time of radiation||||Gy||95% Confidence Interval|Mean
2826531|NCT00328770|Secondary|Sirolimus Toxicity/Intolerance|Sirolimus toxicity/intolerance requiring discontinuation of sirolimus|1 year||||participants|||Number
2826532|NCT00328770|Primary|Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant|Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant|1 and 4 years||||percentage of participants|||Number
2826533|NCT00328770|Primary|Percentage of Participants Surviving at One and Four Years After Liver Transplant|Percent of Patients Surviving at One & Four years after Liver Transplant was calculated|1 & 4 years|Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients|||percentage of participants|||Number
2826534|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826535|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826536|NCT00328627|Secondary|Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826537|NCT00328627|Secondary|Change From Baseline to Week 26 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μmol/L||Standard Error|Least Squares Mean
2826538|NCT00328627|Secondary|Change From Baseline to Week 12 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μmol/L||Standard Error|Least Squares Mean
2826539|NCT00328627|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μMOL/L||Standard Error|Least Squares Mean
2826540|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826541|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826542|NCT00328627|Secondary|Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826543|NCT00328627|Secondary|Change From Baseline to Week 26 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826544|NCT00328627|Secondary|Change From Baseline to Week 12 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826545|NCT00328627|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826546|NCT00328627|Secondary|Change From Baseline to Week 26 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826547|NCT00328627|Secondary|Change From Baseline to Week 12 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826548|NCT00328627|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826549|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826550|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2827048|NCT00325130|Primary|Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2826551|NCT00328627|Secondary|Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nm||Standard Error|Least Squares Mean
2826552|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates"|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826553|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826554|NCT00328627|Secondary|Change From Baseline in VLDL Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826555|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826556|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826557|NCT00328627|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826558|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826559|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826560|NCT00328627|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||nmol/L||Standard Error|Least Squares Mean
2826573|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826561|NCT00328627|Secondary|Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826562|NCT00328627|Secondary|Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826563|NCT00328627|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)|"Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826564|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826565|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826566|NCT00328627|Secondary|Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826567|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826568|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826569|NCT00328627|Secondary|Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826570|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826571|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826572|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2827049|NCT00325078|Other Pre-specified|Gut Immune Cell Types and Their Cytokine Profile|Gut Immune cell types and their cytokine profile|1 year|||||||
2826574|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826575|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826576|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
2826577|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
2826578|NCT00328627|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)|"The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B).~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage beta cell function||Standard Error|Least Squares Mean
2826579|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
2826580|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
2826581|NCT00328627|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)|"HOMA IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||insulin resistance||Standard Error|Least Squares Mean
2826582|NCT00328627|Secondary|Change From Baseline to Week 26 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
2826583|NCT00328627|Secondary|Change From Baseline to Week 20 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
2826584|NCT00328627|Secondary|Change From Baseline to Week 12 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
2826586|NCT00328627|Secondary|Change From Baseline in Body Weight Over Time (Grouped Analysis)|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Weeks 8, 12, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||kg||Standard Error|Least Squares Mean
2826587|NCT00328627|Secondary|Change From Baseline to Week 26 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
2826588|NCT00328627|Secondary|Change From Baseline to Week 12 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
2826589|NCT00328627|Secondary|Change From Baseline in Adiponectin Over Time (Grouped Analysis)|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||μg/mL||Standard Error|Least Squares Mean
2826590|NCT00328627|Secondary|Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
2826591|NCT00328627|Secondary|Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
2826592|NCT00328627|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)|"Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/L||Standard Error|Least Squares Mean
2826593|NCT00328627|Secondary|Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826594|NCT00328627|Secondary|Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826595|NCT00328627|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)|"Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826596|NCT00328627|Secondary|Change From Baseline to Week 26 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
2826597|NCT00328627|Secondary|Change From Baseline to Week 12 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
2826625|NCT00328627|Secondary|Change From Baseline to Week 4 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2827094|NCT00324675|Secondary|Renal Function||at abseline and after 6 and 12 mo|||||||
2826598|NCT00328627|Secondary|Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mmol/L||Standard Error|Least Squares Mean
2826599|NCT00328627|Secondary|Change From Baseline to Week 26 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826600|NCT00328627|Secondary|Change From Baseline to Week 20 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826601|NCT00328627|Secondary|Change From Baseline to Week 16 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826602|NCT00328627|Secondary|Change From Baseline to Week 12 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826603|NCT00328627|Secondary|Change From Baseline to Week 8 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826604|NCT00328627|Secondary|Change From Baseline to Week 4 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826605|NCT00328627|Secondary|Change From Baseline in Triglycerides Over Time (Grouped Analysis)|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826606|NCT00328627|Secondary|Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826607|NCT00328627|Secondary|Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826608|NCT00328627|Secondary|Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826609|NCT00328627|Secondary|Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826610|NCT00328627|Secondary|Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826611|NCT00328627|Secondary|Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826612|NCT00328627|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826613|NCT00328627|Secondary|Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826614|NCT00328627|Secondary|Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826615|NCT00328627|Secondary|Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826616|NCT00328627|Secondary|Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826617|NCT00328627|Secondary|Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826618|NCT00328627|Secondary|Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826619|NCT00328627|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826620|NCT00328627|Secondary|Change From Baseline to Week 26 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826621|NCT00328627|Secondary|Change From Baseline to Week 20 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826622|NCT00328627|Secondary|Change From Baseline to Week 16 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826623|NCT00328627|Secondary|Change From Baseline to Week 12 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826624|NCT00328627|Secondary|Change From Baseline to Week 8 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826666|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826626|NCT00328627|Secondary|Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826627|NCT00328627|Secondary|Change From Baseline to Week 26 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826628|NCT00328627|Secondary|Change From Baseline to Week 20 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826629|NCT00328627|Secondary|Change From Baseline to Week 16 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826630|NCT00328627|Secondary|Change From Baseline to Week 12 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826631|NCT00328627|Secondary|Change From Baseline to Week 8 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826632|NCT00328627|Secondary|Change From Baseline to Week 4 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826633|NCT00328627|Secondary|Change From Baseline in C-peptide Over Time (Grouped Analysis)|"C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ng/mL||Standard Error|Least Squares Mean
2826634|NCT00328627|Secondary|Change From Baseline to Week 26 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826635|NCT00328627|Secondary|Change From Baseline to Week 20 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826636|NCT00328627|Secondary|Change From Baseline to Week 16 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826637|NCT00328627|Secondary|Change From Baseline to Week 12 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826638|NCT00328627|Secondary|Change From Baseline to Week 8 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826692|NCT00328562|Secondary|Progression-free Survival||Baseline to date of progression||||months||Full Range|Median
2826639|NCT00328627|Secondary|Change From Baseline to Week 4 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826640|NCT00328627|Secondary|Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||ratio||Standard Error|Least Squares Mean
2826641|NCT00328627|Secondary|Change From Baseline to Week 26 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826642|NCT00328627|Secondary|Change From Baseline to Week 20 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826643|NCT00328627|Secondary|Change From Baseline to Week 16 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826644|NCT00328627|Secondary|Change From Baseline to Week 12 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826645|NCT00328627|Secondary|Change From Baseline to Week 8 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826646|NCT00328627|Secondary|Change From Baseline to Week 4 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826647|NCT00328627|Secondary|Change From Baseline in Insulin Over Time (Grouped Analysis)|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||µIU/mL||Standard Error|Least Squares Mean
2826648|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826649|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826650|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826651|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826652|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826653|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826654|NCT00328627|Secondary|Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||pmol/L||Standard Error|Least Squares Mean
2826655|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826656|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26.|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826657|NCT00328627|Primary|Change From Baseline to Week 26 in HbA1c|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826658|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826659|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826660|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826661|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826662|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826663|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826664|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826665|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2827095|NCT00324675|Secondary|Renal Hemodynamic||at baseline and after 6 and 12 mo of tretament|||||||
2826667|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826668|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826669|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
2826670|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26|Full analysis set including patients with at least 1 postbaseline visit.|||percentage of participants|||Number
2826671|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26.|Full analysis set including patients with at least 1 postbaseline visit. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.|||percentage of participants|||Number
2826672|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.|||percentage of participants|||Number
2826673|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)|"Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.|||percentage of participants|||Number
2826674|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826675|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826676|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826677|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826678|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826679|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2827096|NCT00324675|Primary|Proteinuria||at baseline and after 6 and 12 mo of treatment|per protocol|||g/24hr||Standard Error|Mean
2826680|NCT00328627|Secondary|Change From Baseline to Week 2 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 2|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826681|NCT00328627|Secondary|Change From Baseline to Week 1 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 1|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826682|NCT00328627|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)|"The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates."|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||mg/dL||Standard Error|Least Squares Mean
2826683|NCT00328627|Secondary|Change From Baseline to Week 20 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826684|NCT00328627|Secondary|Change From Baseline to Week 16 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826685|NCT00328627|Secondary|Change From Baseline to Week 12 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826686|NCT00328627|Secondary|Change From Baseline to Week 8 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826687|NCT00328627|Secondary|Change From Baseline to Week 4 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826688|NCT00328627|Secondary|Change From Baseline in HbA1c Over Time (Grouped Analysis)|"The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates."|Baseline and Weeks 4, 8, 12, 16 and 20.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826689|NCT00328627|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)|"The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone)."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2826690|NCT00328614|Primary|Maximum Tolerated Dose of Samarium-153|"To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT).~Dose levels:~Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV~Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose."|5 months (1 month HT, administration of drug, 4 months HT and RT)||||mCi/kg|||Number
2826691|NCT00328562|Secondary|Survival From Starting Gefitinib||Baseline to date of expiration||||months||Full Range|Median
2826693|NCT00328562|Secondary|Tumor Response|"Definitions of objective tumor response~Complete response - disappearance of all target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions~Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started"|Baseline, 1, 3, and 5 months post-treatment||||participants|||Number
2826694|NCT00328562|Primary|Patients Affected by Treatment-related Morbidities|"See Adverse Events section for specific toxicities"|Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy||||participants|||Number
2826695|NCT00328510|Primary|Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability|This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.|Measurements taken during SRT||||millimeters|Participants|Standard Deviation|Mean
2826696|NCT00328263|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics|Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1|Up to 40 days|||||||
2826697|NCT00328263|Secondary|Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients||Up to 40 days|||||||
2826698|NCT00328263|Secondary|Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.|Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.|Up to 40 days|||||||
2826699|NCT00328263|Primary|The Incidence of Antibiotic-associated Diarrhea.|Presence of at least one diarrhea episode within 24 hours.|Up to 40 days||||participants|||Number
2826700|NCT00328198|Primary|Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.|up to 44 weeks|Full analysis set. 95% confidence interval calculated using exact binomial method.|||percentage of participants||95% Confidence Interval|Number
2826701|NCT00328198|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.|up to 18 weeks of treatment plus 45 days|Full analysis set|||participants|||Number
2826702|NCT00328198|Secondary|Participants With a Minimal Residual Disease (MRD) Status of Negative|MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.|44 weeks|Full analysis set|||participants|||Number
2826703|NCT00328198|Secondary|Kaplan-Meier Estimates of Overall Survival|Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.|up to 5 years|Full analysis set|||months||95% Confidence Interval|Median
2826704|NCT00328198|Secondary|Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)|"Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.~Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Participants who had a complete response or a partial response|||months||95% Confidence Interval|Median
2826705|NCT00328198|Secondary|Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)|"Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.~Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Full analysis set|||months||95% Confidence Interval|Median
2826706|NCT00328198|Primary|Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|up to 44 weeks|Full analysis set|||participants|||Number
2827097|NCT00324649|Secondary|Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.||48 weeks|Treated participants.|||Percentage of participants|||Number
2826708|NCT00328172|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
2826709|NCT00328172|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12|The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Least Squares Mean
2826710|NCT00328094|Primary|Composite (Myocardial Infarction and CHF)||hospital length of stay||||Number of patients|||Number
2826711|NCT00328094|Secondary|Incidence of Wound Infections||postoperative||||participants|||Number
2826712|NCT00328042|Secondary|Hepatitis C Knowledge Questionnaire|The measure consists of 15 questions covering Hepatitis C-specific information related to disease self-management. Each correct response is scored as one point, with total scores range from 0 to 15. Higher scores indicate higher levels of Hepatitis C-specific knowledge. There are no subscales.|Base Line, 6 weeks||||units on a scale||Standard Deviation|Mean
2826713|NCT00328042|Primary|Quality of Well-being Scale - Self-Administered (QWB-SA)|The QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life.|Base Line, 12 months||||units on a scale||Standard Deviation|Mean
2826714|NCT00328016|Secondary|End Tidal CO2 (PetCO2)|End tidal CO2 was monitored continuously using a respiratory gas monitor|After 15 minutes of guided breathing or control task||||mmHg||Standard Error|Mean
2826715|NCT00328016|Secondary|Minute Ventilation|Minute Ventilation was continuously monitored via inductive plethysmography|After 15 minutes of guided breathing or control task||||L/min||Standard Error|Mean
2826716|NCT00328016|Primary|Breathing Rate|Breathing rate was monitored continuously via inductive plethysmography.|After 15 minutes of guided breathing or control task||||Breaths/minute||Standard Error|Mean
2826717|NCT00327717|Secondary|Drop - Out Rate|Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.|16 weeks|FAS Population|||Number of Participants|||Number
2826718|NCT00327717|Secondary|Percentage of Seizure-free Participants During Fixed-dose Phase|Percentage of seizure-free participants during fixed-dose phase|16 weeks|FAS Population|||Percentage of Participants|||Number
2826719|NCT00327717|Secondary|Mean Time to First Seizure (Days)|Mean time to first seizure during fixed dose phase|16 weeks|FAS Population|||Days||Standard Deviation|Mean
2826720|NCT00327717|Secondary|Mean Percentage of Change in Seizure Free Days||16 weeks|FAS Population|||Percent Change||Standard Deviation|Mean
2826721|NCT00327717|Secondary|Mean Number of Seizure Free Days|Mean number of seizure free days per 28 day period during fixed dose phase|12 weeks|FAS Population|||Days||Standard Deviation|Mean
2826722|NCT00327717|Secondary|Responder Rate|Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.|Baseline and 16 weeks|FAS Population|||Percentage of Participants|||Number
2826723|NCT00327717|Secondary|The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)|The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Secondary generalization patients|||Percent Change||Standard Deviation|Mean
2826724|NCT00327717|Secondary|The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency|The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Simple partial seizure patients|||Percent Change||Standard Deviation|Mean
2826725|NCT00327717|Secondary|The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency|The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS population. Complex partial seizure patients|||Percent Change||Standard Deviation|Mean
2826726|NCT00327717|Primary|Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase|The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.|Baseline and 16 weeks|Full analysis set (FAS)|||Percent Change||Full Range|Median
2826727|NCT00327470|Secondary|Mean Change in Euro QoL Questionnaire (EQ-5D) Score|"The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (no problem, some problems and extreme problems). A subject's responses to these domains were mapped to a corresponding score of the EQ-5D index."|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Scores on a scale||Standard Deviation|Mean
2826728|NCT00327470|Secondary|Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score|Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Scores on a scale||Standard Deviation|Mean
2827121|NCT00324415|Secondary|Overall Survival|Percentage of participants who are alive at one year|1 year||||percentage of participants||95% Confidence Interval|Number
2826729|NCT00327470|Secondary|Mean Change From Baseline in Contrast Sensitivity|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline through Week 54, Baseline through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Correctly read letters||Standard Deviation|Mean
2826730|NCT00327470|Secondary|Mean Change in Reading Speed|For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Correctly read words per minute||Standard Deviation|Mean
2826731|NCT00327470|Secondary|Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions|Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.|Baseline through Week 54, Baseline through Week 102|MITT LOCF. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.|||Scores on a scale||Standard Deviation|Mean
2826732|NCT00327470|Secondary|Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.|Baseline through Week 102, Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.|||Scores on a scale||Standard Deviation|Mean
2826733|NCT00327470|Primary|Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.|Baseline through Week 54|The modified intent-to-treat (MITT) population included all subjects in the safety population who had a Baseline distance VA measurement and at least 1 post-Baseline VA measurement. Last observation carried forward (LOCF). Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.|||Scores on a scale||Standard Deviation|Mean
2826734|NCT00327444|Secondary|Plasma Levels of Free and VEGF-bound Aflibercept|"Free aflibercept and VEGF-bound aflibercept plasma concentrations were measured by separate enzyme-linked immunosorbent assay (ELISA). The limit of quantitation of free aflibercept was 15.6 ng/mL, and of VEGF-bound aflibercept was 43.9 ng/mL.~Peak free aflibercept was estimated at the end of Cycle 1 (C1) administration. The median free and VEGF-bound trough concentrations were determined for each participant beyond Cycle 3 (C3), then mean values were estimated from these median values."|Following every biweekly treatment administration up to 60 days after treatment discontinuation|The analysis was performed using the safety population with evaluable blood samples. 42 participants were evaluated.|||μg/mL||Standard Deviation|Mean
2826735|NCT00327444|Secondary|60-Day Frequency of Paracentesis (FOP)|60-Day FOP was defined as the total number of paracenteses performed within the first 60 days after randomization during the double blind treatment period.|From Day 1 up to 60 days from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.|||paracentesis||Standard Error|Least Squares Mean
2826736|NCT00327444|Secondary|Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)|"AIM 4 symptoms (abdominal discomfort, abdominal bloating, abdominal pain, and ability to move normally) are scored from 0 to 5, where higher scores represent worst outcomes. An AIM total score ranges from 0-20.~A plot for (The AIM questionnaire total score - Baseline score) versus time were generated. AIM AUC represents the overall improvement (scored positive) if the area is below the baseline value or worsening (scored negative) if the area is above the baseline. AIM AUC for a participant is the sum of individual areas representing improvement (+) or worsening (-)."|From Day 1 up to 60 days from randomization to the first postrandomization paracentesis|The intent-to-treat (ITT) population - all participants who were randomized in the study, and had evaluable AIM scores.|||(units on a 4-symptom scale)*day||Standard Error|Least Squares Mean
2826737|NCT00327444|Primary|Time to Repeat Paracentesis (TRP)|"TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis.~For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period."|From Day 1 up to 6 months from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.|||days||Standard Error|Least Squares Mean
2826738|NCT00327392|Primary|Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures||2 hours|Number of patients requiring specified types of airway assistance|||particpants|||Number
2827122|NCT00324415|Secondary|Colostomy-free Survival at 1 Year|Percentage of participants who are alive and have not had a colostomy|1 year||||percentage of participants||95% Confidence Interval|Number
2826739|NCT00327340|Secondary|Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.|Serum clusterin samples were collected prior to receiving OGX-011 loading dose 1, prior to study treatment on Day 1 of each cycle, and at the end of treatment. PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit, and during off-treatment follow-up. PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.|Enrollment until disease progression (up to 13 months)|All 69 subjects were included. Data are presented for the 20 subjects who achieved a 50% decline in PSA (6 subjects who received mitoxantrone and prednisone in combination with OGX-011 and 14 subjects who received docetaxel and prednisone in combination with OGX-011)|||percentage of participants|||Number
2826740|NCT00327340|Secondary|Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression|Time to pain progression was defined as the time (months) from the first dose of OGX-011 to the first documentation of pain or analgesic progression or initiation of palliative radiation therapy. Pain response was defined as either a decrease of at least two points on the 11-point Worst Pain Scale, without an increase in analgesic level, maintained for at least two consecutive measurements approximately three weeks apart -or- a decrease in analgesic level, without an increase in pain score, maintained for at least two consecutive measurements approximately three weeks apart.|Enrollment until pain progression (up to 21 months)|Subjects were evaluable for pain response if they had a baseline Worst Pain Score ≥ 2 or were on opioid analgesics at baseline.|||months||95% Confidence Interval|Number
2826741|NCT00327340|Secondary|Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response|PSA or prostate specific antigen is a marker for prostate cancer. A PSA response was defined as a decrease in PSA values of ≥ 50% relative to baseline on two or more consecutive measurements that were 4-6 weeks apart.|PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months)|"Subjects were evaluable for PSA response if they had baseline PSA and at least two post baseline PSA values.~One subject was not evaluable for PSA response; he had only one post baseline PSA value. A PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart."|||percentage of participants||95% Confidence Interval|Number
2826742|NCT00327340|Primary|Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.|"Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).~The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE."|Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)|The total analysis population was 69 subjects: 70 subjects were enrolled; 45 were randomly assigned to treatment (24 to OGX-011/mitoxantrone and 21 to OGX-011 /docetaxel). An additional 25 subjects were assigned to OGX-011/docetaxel. One subject in the mitoxantrone arm was ineligible and did not receive study treatment.|||percentage of participants|||Number
2826743|NCT00327171|Secondary|Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire|The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome.|On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2|All randomized participants who had evaluable FACT-O questionnaires.|||score on a scale||Standard Deviation|Mean
2826744|NCT00327171|Secondary|Overall Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse event|Safety population: All randomized participants who received at least part of one dose of study treatment.|||participants|||Number
2826745|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.~Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||participants|||Number
2826746|NCT00327171|Secondary|Overall Survival (OS) Time|"OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves~A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||weeks|Participants|95% Confidence Interval|Median
2826747|NCT00327171|Secondary|Progression-free Survival (PFS) Time Based on Analysis by the IRC|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves.~For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||weeks|Participants|95% Confidence Interval|Median
2826748|NCT00327171|Secondary|Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier.~The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||participants|||Number
2826749|NCT00327171|Secondary|Time to Tumor Marker (CA-125) Progression (TTMP)|"TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves.~For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Participants with a valid assessment of CA-125 (requiring at least one pretreatment sample and 2 post-treatment samples).|||weeks|Participants|95% Confidence Interval|Median
2826750|NCT00327171|Secondary|Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC|"TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves.~For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||weeks|Participants|95% Confidence Interval|Median
2826751|NCT00327171|Secondary|Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition|TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =< 110% of the post-treatment serum sample.|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Randomized participants who received at least part of one dose of aflibercept, had a baseline tumor assessment, had a valid CA-125 assessment (requiring at least two pretreatment sample and 2 post-treatment samples), did not receive mouse antibodies and had no medical or surgical interference with their peritoneum or pleura in the previous 28 days.|||percentage of participants||95% Confidence Interval|Mean
2826752|NCT00327171|Secondary|Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC)|"DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier.~Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.|||days||Standard Deviation|Mean
2826753|NCT00327171|Secondary|Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC|"CBR was defined as having a Stable disease (SD) for >= 6 months or a confirmed OR (PR or CR). Based on RECIST:~SD was neither a sufficient shrinkage of the target lesions to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), the persistence of non-target lesions or the maintenance of tumor marker level above the normal limits (for non-target lesions)~CR was the disappearance of all target or non-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.|||participants|||Number
2826765|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2827123|NCT00324415|Secondary|Relapse-free Survival|Percentage of participants who are alive and have not experienced progressive disease and have not relapsed|1 year||||percentage of participants||95% Confidence Interval|Number
2826754|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.~Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.|||participants|||Number
2826755|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.|||Percentage of participants|||Number
2826756|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.|||Percentage of participants|||Number
2826757|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
2826758|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of Participants|||Number
2826759|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
2826760|NCT00327015|Primary|Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||percent||Standard Error|Mean
2826761|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
2826762|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
2826763|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
2826764|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2826766|NCT00327015|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||percent||Standard Error|Mean
2826767|NCT00326963|Secondary|Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events|The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.|Up to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||participants|||Number
2826768|NCT00326963|Secondary|Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.|Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up. Maximum number of participants available at the particular time point were analysed and reported.|||participants|||Number
2826769|NCT00326963|Secondary|Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||Percentage of participants|||Number
2826770|NCT00326963|Secondary|Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||participants|||Number
2826771|NCT00326963|Secondary|Percentage of Participants Adhering to ENF|"Adherence to ENF treatment regimen was calculated using the participant's response to the query on the Participant Adherence Questionnaire case report form (CRF) about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24."|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||Percentage of Participants|||Number
2826772|NCT00326963|Secondary|Number of Participants Adhering to Enfuvirtide (ENF)|"Adherence to ENF treatment regimen was calculated using the participant's response to the query on the Participant Adherence Questionnaire case report form (CRF) about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24."|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population.The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||participants|||Number
2826783|NCT00326963|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
2826784|NCT00326950|Secondary|Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.||3 weeks|||||||
2826785|NCT00326950|Primary|Maximum Tolerated Dose (MTD)|MTD was the lowest dose at which a dose limiting toxicity occurred.|3 Weeks||||mg/m^2|||Number
2826773|NCT00326963|Secondary|Percentage of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of participants|||Number
2826774|NCT00326963|Secondary|Number of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
2826775|NCT00326963|Secondary|Change From Baseline in CD4+ Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) - (CD4+ count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||cells/mm^3||Standard Deviation|Mean
2826776|NCT00326963|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.|Up to Week 28|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.|||participants|||Number
2826777|NCT00326963|Secondary|Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load|Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) - (plasma HIV-1 RNA count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.|||copies/mL||Standard Deviation|Mean
2826778|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
2826779|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
2826780|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of Participants||95% Confidence Interval|Number
2826781|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||participants|||Number
2826782|NCT00326963|Primary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.|||Percentage of Participants||97.5% Confidence Interval|Number
2826786|NCT00326950|Primary|Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)|DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.|3 weeks||||participants|||Number
2826787|NCT00326924|Secondary|Number of Participants Using Mechanical Ventilation.|Number of Participants using Mechanical Ventilation|whether a mechanical ventilation was used at any time point during 90 days||||participants|||Number
2826788|NCT00326924|Secondary|Length of Stay|Length of Stay in neonatal intensive unit|until last participants left neonatal intensive care unit||||number of days||Inter-Quartile Range|Mean
2826789|NCT00326924|Secondary|Clinically Suspected Infection and Culturally Confirmed Infections|Infection was categorized as clinically suspected and positive cultures.|90 days||||number of participants|||Number
2826790|NCT00326924|Primary|1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality|The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage.|2 weeks, 4 weeks, 12 weeks, 90 days||||participants|||Number
2826791|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826792|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826793|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826794|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826795|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826796|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Legal Concerns question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826797|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826798|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population|||Scores on a scale||Standard Deviation|Mean
2826799|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population|||Scores on a scale||Standard Deviation|Mean
2826857|NCT00326716|Primary|Infant Gender||At the time of delivery|All infants.|||Participants|||Number
2826800|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population|||Scores on a scale||Standard Deviation|Mean
2826801|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826802|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population|||Scores on a scale||Standard Deviation|Mean
2826803|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826804|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population|||Scores on a scale||Standard Deviation|Mean
2826805|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826806|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826807|NCT00326911|Secondary|Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population|||Scores on a scale||Standard Deviation|Mean
2826808|NCT00326911|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|All patients who received any quantity of study therapy were included in the safety evaluation (safety population, as treated).|||Participants|||Number
2826809|NCT00326911|Secondary|Time to Progression (TTP)|Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date.|Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)|The TTP was based on the mITT population. For patients lost to follow-up, they were censored at the next scheduled visit.|||months||95% Confidence Interval|Median
2826858|NCT00326716|Primary|Infant Gestational Age at Delivery||At the time of delivery|All infants.|||Weeks||Standard Error|Mean
2826810|NCT00326911|Secondary|Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).|CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm.|First day of treatment to the end of Cycle 2, Week 1|The CA19-9 response rate was calculated for at least the 15 patients in each arm of the study at the end of the first two cycles of therapy (8 weeks) in the mITT population who had elevated CA19-9 levels at baseline.|||Percentage of participants|||Number
2826811|NCT00326911|Secondary|The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The best overall response was based on the mITT population for those patients who either had a CR or PR.|||Participants|||Number
2826812|NCT00326911|Secondary|Overall Survival (OS)|This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).|The overall survival was based on the mITT population.|||Months||95% Confidence Interval|Median
2826813|NCT00326911|Primary|Progression-free Survival (PFS)|Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.|Time from randomization to disease progression or death from any cause (Range: 0 -10 months)|The PFS was based on the modified Intent-to-Treat (mITT) population, which included any patient who enrolled, was randomized, and received any quantity of study drug.|||months||95% Confidence Interval|Median
2826814|NCT00326898|Other Pre-specified|Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0||Assessed every 6 weeks while on treatment and for 30 days after the end of treatment|||||||
2826815|NCT00326898|Other Pre-specified|The Association Between Scan Frequency and Development of Congestive Heart Failure||Assessed at 3, 6 and 12 months|||||||
2826816|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form|PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue|Assessed at baseline, 10 weeks and 22 weeks|||||||
2826817|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale||Assessed at baseline, 10 weeks and 22 weeks|||||||
2826818|NCT00326898|Other Pre-specified|The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
2826819|NCT00326898|Other Pre-specified|The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
2826820|NCT00326898|Other Pre-specified|The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
2826821|NCT00326898|Other Pre-specified|The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
2826822|NCT00326898|Other Pre-specified|The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
2826823|NCT00326898|Other Pre-specified|The Association Between Angiogenesis Markers and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|||||||
2826824|NCT00326898|Secondary|5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|Patients with clear cell histology were included in this analysis.|||proportion of participants||97.5% Confidence Interval|Number
2826825|NCT00326898|Secondary|Proportion of Patients With Cardiac Events|Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|Patients with at least 1 follow-up MUGA scan were included in this analysis.|||Proportion of participants||90% Confidence Interval|Number
2826826|NCT00326898|Secondary|5-year Overall Survival Rate|Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|All randomized patients|||proportion of participants||97.5% Confidence Interval|Number
2826827|NCT00326898|Primary|Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients|||years||97.5% Confidence Interval|Median
2826828|NCT00326885|Primary|Increase of Paracentesis/Puncture-free Interval (Ratio)|The parameter to be tested is the ratio of the post-treatment puncture/paracentesis-free interval divided by the pre-treatment puncture/paracentesis-free interval. The pre-treatment interval is defined as the length of time between the patient`s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|180 days||||fold||Full Range|Median
2826829|NCT00326885|Secondary|Ascites Volume|Ascites volume measurement were to be performed at screening (= prior to baseline), at baseline (= before start of therapy with catumaxomab) and during the 6-month follow-up period when the patient had recurrence of symptomatic ascites requiring therapeutic paracentesis. At each paracentesis, drainage to dryness was to be achieved and the exact volume was to be measured and documented.|6 months||||mL||Full Range|Median
2826830|NCT00326885|Secondary|Ascites Signs and Symptoms|"Patient-reported ascites symptoms were to be assessed using the patient questionnaire, Functional Assessment of Chronic Illness Therapy - Ascites Index (FACIT-AI). At 6 months following catumaxomab administration, the patient was requested to assess the severity of the following parameters during the past week using a 5-point scale with scores from 0 = not at all to 4 = very much: anorexia, insomnia, decreased mobility, dyspnea, nausea, vomiting, abdominal pain, abdominal distention, fatigue, early satiety, urinary frequency, constipation, and emotional distress. For the parameters anorexia, insomnia, and decreased mobility, high scores mean good response, for the other parameters low scores mean good response."|6 months||||units on a scale||Full Range|Median
2826831|NCT00326885|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of first dose to the date of death.|≥ 6 months||||months||95% Confidence Interval|Median
2826832|NCT00326885|Secondary|Puncture/Paracentesis-free Survival (PuFS)|Puncture/Paracentesis-free Survival (PuFS), Defined as the Number of Days Between the Date of Last Dose and the Date of Documented End of Study (EoS) Paracentesis or Death, Whichever Occurred First|≥6 months|Full analysis set (FAS) Per protocol (PP)|||weeks||Full Range|Median
2826833|NCT00326885|Primary|The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.|The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient's most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|6 months||||proportion of patients|||Number
2826834|NCT00326872|Secondary|Reduction in Self Reported Worst Pain Per Cycle.|Reduction in self reported worst pain per cycle as measured by the Worst Pain scale from the North Central Cancer Treatment Group Brief Pain Inventory (short form). The worst pain scale is from 0-10 (10 is worst pain possible). The per-cycle average reduction in worst pain will be analyzed using generalized linear models to account for repeated measures within patients.|At baseline, prior to each subsequent course (q 28+/- 3 days), and at end of treatment up to 51 months||||units on a scale of 0-10||Standard Error|Mean
2826835|NCT00326872|Secondary|Time to Treatment Failure as Assessed Using the Method of Kaplan-Meier|"Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment.~Time to treatment failure will be estimated using the method of Kaplan-Meier."|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal up to 51 months.||||Months||95% Confidence Interval|Median
2826836|NCT00326872|Secondary|Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response is defined for all evaluable patients who have achieved a confirmed tumor objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be estimated using the method of Kaplan-Meier.|From time of confirmed tumor objective response as CR or PR to the date of progression max 51 months|There was only 1 response and due to patient confidentiality we are not reporting this endpoint.||||||
2826837|NCT00326872|Secondary|Time to Disease Progression as Measured Using Kaplan-Meier Method|"Progression (PD): At least a 20% increase in the sum of volumes of target lesions taking as reference the smallest volume recorded since the treatment started or the appearance of one or more new lesions.~If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death."|From registration to documentation of disease progression up to 26 cycles (28 days/cycle).||||Months||95% Confidence Interval|Median
2826838|NCT00326872|Secondary|Survival Time as Measured Using Kaplan-Meier Method|Survival time is defined as the time from registration to death due to any cause.|From registration to death (due to any cause) max 51 months||||Months||95% Confidence Interval|Median
2826839|NCT00326872|Primary|Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])|"Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the volume of target lesions taking as reference the baseline volume."|Baseline to end of treatment, maximum of 26 cycles (28 days/cycle).||||Proportion of patients||95% Confidence Interval|Number
2826840|NCT00326781|Secondary|Verified 7-day Point Prevalence Abstinence at End Of Treatment.|"End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.~This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey."|End of Treatment||||participants|||Number
2826841|NCT00326781|Primary|Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)|A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).|End of Treatment (8-weeks after quit date)|Analysis was intention to treat (ITT)|||Participants|||Number
2826842|NCT00326716|Primary|Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||Hours||95% Confidence Interval|Geometric Mean
2826843|NCT00326716|Primary|Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||Hours||95% Confidence Interval|Geometric Mean
2826844|NCT00326716|Primary|Mean RTV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set|||Hours||95% Confidence Interval|Geometric Mean
2826845|NCT00326716|Secondary|Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose|The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum|All treated participants were included in this evaluation.|||Participants|||Number
2826846|NCT00326716|Secondary|Mean Atazanavir Plasma Protein Binding|Atazanavir Plasma Protein Binding Percentage measured at specified time points.|Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery||||Percentage Bound||Standard Deviation|Mean
2826847|NCT00326716|Secondary|Median Infant Total Bilirubin Level|Median infant total bilirubin level as measured at specified time points.|Birth (Day 1), Day 3, Day 5, and Day 7 of Life||||mg / dL||Inter-Quartile Range|Median
2826848|NCT00326716|Secondary|Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration|Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.|At Time of Delivery||||ng / mL||Standard Deviation|Mean
2826849|NCT00326716|Primary|Mean ATV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||Hours||95% Confidence Interval|Geometric Mean
2826850|NCT00326716|Primary|Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
2826851|NCT00326716|Primary|Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
2826852|NCT00326716|Primary|Mean RTV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
2826853|NCT00326716|Primary|Mean ATV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||ng•h / mL||95% Confidence Interval|Geometric Mean
2826854|NCT00326716|Primary|Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.|||ng / mL||95% Confidence Interval|Geometric Mean
2826855|NCT00326716|Primary|Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the pharmacokinetic (PK) concentration data set.|||ng / mL||95% Confidence Interval|Geometric Mean
2826856|NCT00326716|Primary|Infant Race||At the time of delivery|All infants.|||Participants|||Number
2826859|NCT00326716|Secondary|SAEs in Enrolled Infants|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|Birth Through Week 16 of Life|SAEs were recorded for all enrolled infants.|||Participants|||Number
2826860|NCT00326716|Secondary|SAEs in Enrolled Mothers|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|During Study Period and 30 Days Post-Study.|Data were analyzed for all treated and untreated mothers.|||Participants|||Number
2826861|NCT00326716|Secondary|Number of Participants With Grade 2 to Grade 4 AEs and SAEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal [ULN] [mild], Grade 2=1.6 to 2.5 ULN [moderate], Grade 3=2.6 to 5.0 ULN [severe], Grade 4= > 5.0 ULN [potentially life threatening]).|During Study Period and 30 Days Post-Study.|Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants. The number of AEs and SAEs is based on enrolled participants.|||Participants|||Number
2826862|NCT00326716|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE =any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|During study period and 30 days post-study.|The number of SAEs is based on enrolled participants. Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants.|||Participants|||Number
2826863|NCT00326716|Secondary|Infant HIV Status|The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).|Birth Through 6 Months on Study|All infants.|||Participants|||Number
2826864|NCT00326716|Secondary|Mean CD4 Cell Count at Baseline||Baseline|All treated participants.|||cells / mm^3||Standard Error|Mean
2826865|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count|The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median CD4 Cell Count Change From Baseline was calculated based on all treated mothers. The maternal CD4 cell count at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.|||cells / mm^3||Inter-Quartile Range|Median
2826866|NCT00326716|Secondary|Mean HIV RNA Level at Baseline||Baseline|All treated participants.|||log10 cm / mL||Standard Error|Mean
2826867|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level|The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median maternal HIV RNA Level Change From Baseline was calculated for all treated mothers at the time of delivery. The maternal HIV RNA level at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.|||log10 c / mL||Inter-Quartile Range|Median
2826868|NCT00326716|Secondary|Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery|The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Day of Delivery ± 2 Days|The analysis for the proportion of HIV RNA < 400 and < 50 c/mL at delivery is based on the Virologic Response - Observed Cases (VR-OC). VR-OC classifies subjects who remain on study therapy as responders according to a single HIV RNA measurement < 400 c/mL (or < 50 c/mL) closest to delivery and within delivery date ± 2 days.|||Participants|||Number
2826869|NCT00326612|Secondary|Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.|Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.|24 hours|Analysis was per protocol|||participants|||Number
2826870|NCT00326612|Secondary|Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication||12 hours||||participants|||Number
2826871|NCT00326612|Secondary|Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.||24 hours||||participants|||Number
2826872|NCT00326612|Secondary|Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.||24 hours||||participants|||Number
2826873|NCT00326612|Secondary|Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours||24 hours||||participants|||Number
2826874|NCT00326612|Secondary|Respiratory Depression Requiring Intubation|Respiratory depression was defined as intubation at Emergency Department discharge.|24 hours|Analysis was per protocol|||participants|||Number
2826875|NCT00326612|Primary|Length of Seizure After Study Medication Administration|Length of seizure.|24 hours|Analysis was per protocol|||Minutes||Inter-Quartile Range|Median
2826890|NCT00326209|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.|Baseline, up to follow-up visit (Month 24.5)|Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2826876|NCT00326599|Secondary|Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)|DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.|Cycle 1 (up to 3 weeks)|The first 6 participants treated on Arm I (lead-in phase).|||participants|||Number
2826877|NCT00326599|Secondary|Overall Survival (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All phase II participants who met eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
2826878|NCT00326599|Secondary|Overall Survival at 1 Year After Randomization (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.|1 year|All phase II participants who met eligibility criteria and started the treatment.|||percentage of participants||95% Confidence Interval|Number
2826879|NCT00326599|Secondary|Time to Treatment Failure (Phase II Patients Only)|Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 15 months|All phase II participants who met the eligibility criteria and have ended the study treatment.|||months||95% Confidence Interval|Median
2826880|NCT00326599|Secondary|Progression-free Survival (Phase II Patients Only)|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.|||months||95% Confidence Interval|Median
2826881|NCT00326599|Secondary|Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|6 months|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
2826882|NCT00326599|Primary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)|"A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
2826883|NCT00326495|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|96 months, 26 days|Although 51 patients were accrued, only 50 were on study long enough for assessment.|||Participants|||Count of Participants
2826884|NCT00326495|Primary|Overall Rate of Response|Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|4 months|Although 51 patients were accrued, only 50 were on study long enough for assessment.|||percentage of participants|||Number
2826885|NCT00326417|Secondary|Overall Survival (OS)|OS is defined as alive at 1 year, the event is death from any cause. Patients alive at the time of last observation, for statistical purposes, will have a survival time which is censored.|Day 365||||percentage of participants||95% Confidence Interval|Number
2826886|NCT00326417|Secondary|Chronic GVHD|Chronic GVHD is scored according to the BMT CTN MOP. The first day of chronic GVHD onset will be used to calculate cumulative incidence curves.|Day 365||||percentage of participants||95% Confidence Interval|Number
2826887|NCT00326417|Secondary|Acute Graft vs Host Disease (GVHD)|All GVHD grades 2-4 will be graded according to the BMT CTN Manual of Procedures (MOP)|Day 100||||percentage of participants||95% Confidence Interval|Number
2826888|NCT00326417|Secondary|Cumulative Incidence of Graft Failure|Primary and secondary graft failure are included, secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in the ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days, unresponsive to growth factor.|Day 365||||percentage of participants|||Number
2826889|NCT00326417|Primary|Disease-free Survival (DFS)|DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant.|Day 100||||participants|||Number
2826986|NCT00325416|Other Pre-specified|DNA Topoisomerase I Amount, Activity, or Subcellular Distribution|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)|||||||
2826891|NCT00326209|Primary|Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities|Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and ≥3 decrease, or >20; hematocrit (%): <30 and ≥10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): ≥3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): ≤50.|Baseline up to follow-up (24.5 months)|Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2826892|NCT00326209|Primary|Number of Participants Who Prematurely Discontinued Treatment|Number of participants who prematurely discontinued treatment due to any reason were reported.|Baseline up to Month 24|Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2826893|NCT00326209|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 1) up to follow-up (24.5 months)|Safety population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2826894|NCT00326196|Primary|The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.|Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.|Date of Death and non-fatal MI|The number of participants for analysis was determined by intent to treat principal.|||participants|||Number
2826895|NCT00326183|Primary|Participants With Elevated Temperature (>=102.2F/39.0C)||Days 1 to 5 After Any Vaccination|Includes all subjects who provided body temperature follow-up data after any dose of vaccine.|||participants|||Number
2826896|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
2826897|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
2826898|NCT00326183|Primary|Participants With Rubella-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
2826899|NCT00326183|Primary|Participants With Rubella-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
2826900|NCT00326183|Primary|Participants With Mumps-Like Symptoms After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.|||participants|||Number
2826901|NCT00326183|Primary|Participants With Mumps-Like Symptoms After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.|||participants|||Number
2826902|NCT00326183|Primary|Participants With Measles-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.|||participants|||Number
2826903|NCT00326183|Primary|Participants With Measles-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.|||participants|||Number
2826904|NCT00326183|Primary|Participants With 1 or More Injection-Site Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.|||participants|||Number
2826905|NCT00326183|Secondary|Participants With 1 or More Systemic Adverse Experiences||Days 1 to 14 After Any Vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.|||participants|||Number
2826906|NCT00326183|Primary|Participants With 1 or More Serious Vaccine-Related Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.|||participants|||Number
2826907|NCT00326170|Primary|Number of Participants With Response|Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/L or more and platelet count of 100x10^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CRp).|Up to 12 cycles of treatment (28 day cycles)||||Participants|||Number
2826908|NCT00326118|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.~For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually."|Throughout the entire study period (up to year 5)|Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.|||Subjects|||Number
2826909|NCT00326118|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Day 0 - Day 30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.|||Subjects|||Number
2826910|NCT00326118|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite."|Within 4 days (Day 0 -Day 3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.|||Subjects|||Number
2826911|NCT00326118|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2826912|NCT00326118|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values|Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
2826913|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2826914|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2826915|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
2826916|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
2826917|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2826918|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2826919|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
2826920|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|"rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.~Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition."|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.|||Subjects|||Number
2826921|NCT00326118|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer|rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.|||Subjects|||Number
2826922|NCT00326118|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.|||Subjects|||Number
2826923|NCT00326001|Secondary|Number of Patients With Charred Catheter Tips|Char or coagulum formation on the catheter tip|ablation procedure|per protocol|||Patients|||Number
2826924|NCT00326001|Secondary|Number of Patients With Long-term Treatment Success|No recurrence of atrial flutter after ablation|6 months after ablation|per protocol|||Patients|||Number
2826925|NCT00326001|Secondary|Ablation Success With the First Catheter|"Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N).~Positive final bidirectional cavotricuspid isthmus condution block test means ablation successful.~Negative final bidirectional cavotricuspid isthmus condution block test means ablation unsuccessful; ablation should be continued until success or terminated and classified as unsuccess."|ablation procedure|per protocol|||Patients|||Number
2826926|NCT00326001|Primary|Duration of Energy Application|Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.|ablation procedure|Per protocol|||minute||Standard Deviation|Mean
2826927|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from some participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|During Course of Study (either month 3, 6, 9, or 12)|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.|||participants|||Number
2826928|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from 68% of the participants in the azithromycin group and 70% in the placebo group who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|Baseline|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.|||Participants|||Number
2826929|NCT00325897|Secondary|Change in Age-adjusted Hearing Threshold|Assessed by audiometry for four sound frequencies (1000, 2000, 3000, 4000 Hz). The maximum was computed for each threshold in each ear for all frequencies, then the differences between visits were assessed.|Baseline and 12 months|Participants with both baseline and one-year audiometry data available were analyzed.|||Decibels (db)||Standard Deviation|Mean
2826930|NCT00325897|Secondary|Number of Hospital Admissions as a Result of Acute Exacerbations||Measured monthly for 12 months||||Hospitalizations|||Number
2826931|NCT00325897|Secondary|Number of Emergency Department Visits as a Result of Acute Exacerbations||Measured monthly for 12 months||||Visits|||Number
2826932|NCT00325897|Secondary|Exacerbations/Patient Year|"Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly until 13 months|Participants with any follow-up data were analyzed.|||exacerbations/patient year|||Number
2826933|NCT00325897|Primary|Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly through 13 months|Participants that had any follow-up data were included in analysis.|||Days||95% Confidence Interval|Median
2826934|NCT00325819|Secondary|Parent Time Lost From Work|Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.|Through the day after vaccination|Refers to the number of participants for whom parents reported that they were scheduled to work on the day of the vaccination visit or the day following the child's vaccination visit.|||percentage of participants|||Number
2826935|NCT00325819|Secondary|Infant Time Lost From Sleep|Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations||||percentage of participants|||Number
2826936|NCT00325819|Secondary|Parent Time Lost From Sleep|Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations||||percentage of participants|||Number
2826937|NCT00325819|Secondary|Infant Fussiness|Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.|Within 32 hours of vaccination||||percentage of participants|||Number
2826938|NCT00325819|Secondary|Medical Utilization|Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.|Within 32 hours of vaccination.||||percentage of participants|||Number
2826939|NCT00325819|Secondary|Study Assignment Unblinded|The need for unblinding at any time during the study|At any time during participation in the study||||percentage of participants|||Number
2826940|NCT00325819|Secondary|Fever >=39C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=39C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.|||percentage of participants|||Number
2826941|NCT00325819|Primary|Fever >=38C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=38C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.|||percentage of participants|||Number
2826942|NCT00325780|Secondary|Change From Baseline in Total Cholesterol|Mean percent change from baseline in total cholesterol|Baseline to 52 weeks|Patients who had an observation at Week 52|||percent change||Standard Deviation|Mean
2826943|NCT00325780|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)|Baseline to 52 Weeks|Patients who had an observation at Week 52|||percent change||Standard Deviation|Mean
2826944|NCT00325754|Secondary|Mid-day Activity Monitoring at 6 Months|Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM.|6 months||||Vector magnitude units (VMU)/min||Standard Deviation|Mean
2826945|NCT00325754|Secondary|Average Mid-day Activity Monitoring at 3 Months|Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.|3 Months||||Vector magnitude units (VMU)/min||Standard Deviation|Mean
2826946|NCT00325754|Primary|Stationary Oxygen Use Daily||Baseline||||Hours||Standard Deviation|Mean
2826947|NCT00325754|Primary|Ambulatory/Portable Oxygen Use Daily||6 months||||Hours||Standard Deviation|Mean
2826948|NCT00325754|Primary|Stationary Oxygen Use Daily||6 Months||||Hours||Standard Deviation|Mean
2826949|NCT00325598|Secondary|Distant Control Rate|-Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes.|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826950|NCT00325598|Secondary|Regional Control Rate|-Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826951|NCT00325598|Secondary|Local Control Rate|-Local control rate for this study is the number of participants who remained free of disease in their breast.|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826952|NCT00325598|Secondary|Cosmetic Outcome|"Excellent: little or no observable change~Good: minimal but identifiable changes~Fair: significant results of radiotherapy noted~Poor: severe normal tissue sequelae"|Up to 5 years|4 patients in Cohort 1 were not evaluable for this outcome measure because 2 patients did not have the cosmetic outcome performed, 1 patient withdrew consent, and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826953|NCT00325598|Secondary|Incidence of Fat Necrosis|-Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat.|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826954|NCT00325598|Secondary|Incidence of Breast Fibrosis||Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826955|NCT00325598|Secondary|Incidence and Severity of Cutaneous Toxicity|"Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme~Grade 0 = none~Grade 1 = slight atrophy; pigmentation change; some hair loss~Grade 2 = patch atrophy; moderate telangiectasia; total hair loss~Grade 3 = marked atrophy; gross telangiectasia~Grade 4 = ulceration~Worst cutaneous toxicity grade is noted"|Up to 5 years|2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.|||Participants|||Count of Participants
2826956|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity|-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity|Within 1 year of protocol registration||||percentage of participants|||Number
2826957|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan|-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.|Within 1 year of protocol registration||||percentage of participants|||Number
2826958|NCT00325572|Primary|Copper/Zinc Ratio of Children With Autism Compared to Typically Developing Children Phase 2: Change in Copper/Zinc Ratio With Supplementation of Zinc and Vitamin C|Phase 2 was not initiated; no data was collected.|16 weeks|Phase 2 was not initiated; no data was collected.||||||
2826959|NCT00325468|Secondary|Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||Inter-Quartile Range|Median
2826960|NCT00325468|Primary|Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||95% Confidence Interval|Least Squares Mean
2826961|NCT00325468|Primary|Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||95% Confidence Interval|Least Squares Mean
2826962|NCT00325468|Secondary|Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||Inter-Quartile Range|Median
2826963|NCT00325468|Primary|Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8|||percent||95% Confidence Interval|Least Squares Mean
2826964|NCT00325442|Secondary|Change in Symptoms of PAH From Baseline to Week 16|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.|Baseline and 16 weeks||||units on a scale||Standard Error|Mean
2826965|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA and PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA and PDE5-I for 90 days or greater at the time of randomization.|||meters||Inter-Quartile Range|Median
2826966|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with a PDE5-I for 90 days or greater at the time of randomization.|||meters||Inter-Quartile Range|Median
2826967|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA for 90 days or greater at the time of randomization.|||meters||Inter-Quartile Range|Median
2826968|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomization: Study Drug Dose 0.25 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.25 mg for initiation of study drug dosing and dose titration.|||meters||Inter-Quartile Range|Median
2826969|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomizaiton: Dose Strength 0.5 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.5 mg for initiation of study drug dosing and dose titration.|||meters||Inter-Quartile Range|Median
2826970|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Dose Strength Available at Randomization: Smallest Dose Available 1 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 1 mg for initiation of study drug dosing and dose titration.|||meters||Inter-Quartile Range|Median
2826987|NCT00325416|Other Pre-specified|Amount, Activity and Subcellular Distribution of Topoisomerase I With Clinical Response and Toxicity|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (no specific time points)|||||||
2826971|NCT00325442|Post-Hoc|Change in Six Minute Walk Distance (6MWD) From Baseline in Subjects Who Received Oral Treprostinil by Last Study Drug Dose and Reason for Discontinuation|In general, the dose of study drug was increased in 0.5 mg increments every 3 days, in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.|Baseline and 16 weeks|Of 174 subjects randomized to receive oral treprostinil, 153 subjects who completed the study and 6 additional subjects who did not complete the study but discontinued the study due to adverse events were included in this analysis.|||meters||Inter-Quartile Range|Median
2826972|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 4 (398 - 450 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 4 (398 - 450 meters).|||meters||Inter-Quartile Range|Median
2826973|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 3 (363 - 397 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 3 (363 - 397 meters).|||meters||Inter-Quartile Range|Median
2826974|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 2 (303 - 362 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 2 (303 - 362 meters).|||meters||Inter-Quartile Range|Median
2826975|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartiles: Quartile 1 (126-302 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 1 (126 - 302 meters).|||meters||Inter-Quartile Range|Median
2826976|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 4 weeks||||meters||Inter-Quartile Range|Median
2826977|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 8 weeks||||meters||Inter-Quartile Range|Median
2826978|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 12 weeks||||meters||Full Range|Median
2826979|NCT00325442|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Week 16||||participants|||Number
2826980|NCT00325442|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and 16 Weeks|Five subjects in the placebo arm and three subjects in the active arm did not have a Baseline dypsnea-fatigue index score.|||units on a scale||Standard Deviation|Mean
2826981|NCT00325442|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening required one of the following:~Death (all causes excluding accident)~Transplantation or atrial septostomy~Clinical deterioration as defined by:~Hospitalization as a result of PAH, or~≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And~Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin)."|Baseline and 16 Weeks||||participants|||Number
2826982|NCT00325442|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and 16 Weeks|One subject in the placebo arm did not have a Baseline Borg score value.|||units on a scale||Standard Deviation|Mean
2826983|NCT00325442|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 16 Weeks||||meters||Inter-Quartile Range|Median
2826984|NCT00325416|Other Pre-specified|Breast Cancer Resistance Protein (BCRP) Expression|BCRP function will be assayed in multiple myeloma patient bone marrow aspirates obtained before and during high dose chemotherapy. BCRP function is expressed as the change in relative fluorescence in topotecan versus control cells. The distribution of paired differences in BCRP, a continuous variable, will be summarized using descriptive statistics and will be correlated with response and toxicity.|Laboratory study (N/A)|||||||
2826985|NCT00325416|Other Pre-specified|Genomic DNA Sequence Variations and Correlate With Toxicity to Melphalan and Topotecan|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)|||||||
2826988|NCT00325416|Other Pre-specified|Pharmacokinetic Profiles of High Dose Topotecan and Melphalan|Evaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.|Predetermined time points in protocol|||||||
2826989|NCT00325416|Secondary|Phase II Overall Survival (OS)|Time from start of treatment until death from any cause.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis|||months||95% Confidence Interval|Median
2826990|NCT00325416|Secondary|Phase II Event Free Survival (EFS)|Time to treatment failure, which is defined as the time from day 0 to the time of progressive disease. Progressive disease is defined by unequivocal objective evidence and constitutes any of the following: 1). an increase in the total amount of monoclonal protein (M-component from Serum Protein Electrophoresis (SPEP) and/or Urine Protein Electrophoresis (UPEP) with immunofixation) by more than 100% from the lowest level of serum myeloma protein seen after high-dose chemotherapy by serum protein electrophoresis; 2). an increase in the total amount of monoclonal protein above the remission level of the myeloma peak (i.e., an increase of >25% above the lowest level in a 24 hour urine or serum protein; 3). the reappearance of the M-protein if the patient had entered a CR: 4). definite increase in the size (> 1 cm) or number of lytic bone lesions. Compression fractures do not constitute a relapse.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis|||months||95% Confidence Interval|Median
2826991|NCT00325416|Primary|Phase II Participants - Overall Response Rate|Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) participants with responsive disease prior to transplant.|||percentage of participants|||Number
2826992|NCT00325416|Primary|Phase I - Maximum Tolerated Dose (MTD) Level|"MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety.~Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2"|Phase I - 5 years, 2 months|Phase I Dose Escalation participants.|||mg/m^2|||Number
2826993|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
2826994|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
2826995|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration. This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at the time of randomization.~The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
2826996|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data collected from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Wk 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference i"|Baseline and Week 12|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.|||meters||Inter-Quartile Range|Median
2826997|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) by PAH Etiology: Idiopathic or Heritable PAH|"Exploratory efficacy analyses were to determine the effect of PAH etiology (idiopathic/heritable, associated with collagen vascular disease, and other etiologies) on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12||||meters||Inter-Quartile Range|Median
2826998|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification: I or II|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12||||meters||Inter-Quartile Range|Median
2826999|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification III or IV|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12||||meters||Inter-Quartile Range|Median
2827000|NCT00325403|Secondary|Symptoms of PAH|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.|Baseline and Week 12||||units on a scale||Standard Deviation|Mean
2827001|NCT00325403|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 12|Two subjects (one in the placebo arm and one in the oral treprostinil arm) from the primary analysis population (n=228) did not have a Baseline dyspnea-fatigue index score and were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2827002|NCT00325403|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 12||||units on a scale||Inter-Quartile Range|Median
2827003|NCT00325403|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 12|Subjects with a WHO functional classification assessment at Week 12.|||participants|||Number
2827004|NCT00325403|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:~Death (all causes excluding accident)~Transplantation or atrial septostomy~Clinical deterioration as defined by:~Hospitalization as a result of PAH, or~greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And~Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)"|Baseline and Week 12||||participants|||Number
2827013|NCT00325234|Secondary|Duration of Response (DOR)|DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.|Time of response to progressive disease (up to 19 months)|All randomized participants with CR or PR.|||Months||95% Confidence Interval|Median
2827005|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|Analyses were conducted using the modified intention to treat (mITT), which includes subjects who had access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
2827006|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
2827007|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.~The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
2827008|NCT00325403|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).|||meters||Inter-Quartile Range|Median
2827009|NCT00325234|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is presented in the Reported Adverse Event Module.|every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)|All randomized participants who received at least one dose of study drug.|||participants|||Number
2827010|NCT00325234|Secondary|Time to Response|Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.|Baseline to response (up to 7.8 months)|All randomized participants with CR or PR.|||Months||95% Confidence Interval|Median
2827011|NCT00325234|Secondary|Time To Treatment Failure (TTTF)|TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.|Baseline to end of treatment (up to 21.9 months)|All randomized participants|||Months||95% Confidence Interval|Median
2827012|NCT00325234|Secondary|Time to Progressive Disease (PD)|Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.|Baseline to measured PD (up to 25.1 months)|All randomized participants.|||Months||95% Confidence Interval|Median
2827026|NCT00325143|Secondary|Number of Subjects Reporting Any Large Swelling Reactions|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 15, post-booster dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2827014|NCT00325234|Primary|Tumor Response Rate|Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.|Baseline up to 30 days of follow-up after 21 cycles of treatment|All randomized patients who qualified for tumor response analysis by the following criteria: Females with histologic or cytologic diagnosis of advanced breast cancer previously treated with anthracyclines and taxanes. No concurrent antitumor therapy. Presence of measurable disease as defined by RECIST. Treatment with at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2827015|NCT00325195|Secondary|Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life|Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.|Baseline to Final Visit (Month 6 or LOCF)|Number of participants analyzed was based upon the number who had baseline and at least one follow-up assessment, with the final visit for each subject included (LOCF).|||Units on a scale||Standard Deviation|Mean
2827016|NCT00325195|Secondary|Change in Number of Tender Joints|Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.|||Tender joints||Standard Deviation|Mean
2827017|NCT00325195|Secondary|Change in Number of Swollen Joints|Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.|||Swollen joints||Standard Deviation|Mean
2827018|NCT00325195|Secondary|Percentage of Subjects With Gout Flare Per 3-month Period|Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.|Months 1-3 and Months 4-6|Number analyzed in each period was based upon number of participants remaining in study during the assessed treatment period: 85/84/43 in Months 1-3 and 69/69/43 in Months 4-6|||Percent subjects reporting flares|||Number
2827019|NCT00325195|Secondary|Reduction in Tophus Burden|percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.|Baseline and Final Visit (6 months or LOCF)|Number of participants analyzed was based upon the number of patients who had one or more tophus at Baseline, as determined by the PI, AND who had at least one follow-up assessment, with the final visit for each subject included (last observation carried forward).|||Percent subjects with resolved tophus|||Number
2827020|NCT00325195|Primary|Plasma Uric Acid (PUA) Responder|PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.|Months 3 and 6|Modified ITT (all patients receiving at least one dose of study drug). Participants dropping out before Week 25 were imputed as Non-Responders|||Participants|||Number
2827021|NCT00325156|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2827022|NCT00325156|Secondary|Number of Subjects Reporting Large Injection Site Swelling|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 18, post-booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.|||Subjects|||Number
2827023|NCT00325156|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2827024|NCT00325156|Primary|Number of Subjects Reporting Any Solicited Local and General Symptoms|Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.|||Subjects|||Number
2827025|NCT00325143|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 21)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2827027|NCT00325143|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2827028|NCT00325143|Primary|Number of Subjects Reporting Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.|||Participants|||Count of Participants
2827029|NCT00325143|Primary|Number of Subjects Reporting Any Solicited Local Symptoms|Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and who filled in their symptom sheet.|||Participants|||Count of Participants
2827030|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
2827031|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
2827032|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
2827033|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."|||ELISA units/mL||95% Confidence Interval|Geometric Mean
2827034|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have~post-vaccination data."|||mMU/mL||95% Confidence Interval|Geometric Mean
2827035|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have~post-vaccination data."|||mMU/mL||95% Confidence Interval|Geometric Mean
2827036|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||mMU/mL||95% Confidence Interval|Geometric Mean
2827037|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||mMU/mL||95% Confidence Interval|Geometric Mean
2827038|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
2827039|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
2827040|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
2827041|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
2827042|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
2827043|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.|||Participants|||Number
2827044|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2827045|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2827050|NCT00325078|Primary|Efficacy of Treatment With Study Drug|Measured participant Crohn's disease Activity Index (CDAI) values. The CDAI is a tool comprised of clinical and laboratory factors such as stool frequency, consistency, abdominal pain, general well being, weight and blood profile as an objective measure of disease activity. A higher score corresponds to greater severity of inflammatory bowel disease; severe disease conventionally defined as >450, a remission as <150, and a response to treatment as a fall of CDAI of >70 points. Infections and IBD are not expected in healthy control subjects. The greater the score, the more severe the disease, and a score of less than 5 represents clinical remission.|Baseline, 1 year|All participants in the Treatment and Observation Arms with collected CDAI data. The CDAI, a tool validated for Crohn’s disease is not applicable to healthy donors or CGD patients without IBD, and therefore not measured in the Control participants.|||Crohn's disease activity Index|||Number
2827051|NCT00325078|Primary|Safety of Study Drug|Number of Infections from Baseline to 1 year|Baseline to 1 year|The volunteer group includes patients with chronic granulomatous disease as well as healthy normal volunteers as controls. Infection rates only pertain to and are counted in subjects with underlying immunodeficiency (chronic granulomatous disease).|||infections|||Number
2827052|NCT00325039|Secondary|Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months|Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)|12 months|This is the number of participants who had complete UDI information at the 12 month visit.|||units on a scale||Standard Deviation|Mean
2827053|NCT00325039|Secondary|Change in Quality of Life From Baseline to 12 Months|Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).|Baseline - 12 months|These are the number of patients with available quality of life data at the 12 month visit.|||units on a scale||Standard Deviation|Mean
2827054|NCT00325039|Primary|Subjective Treatment Success at 12 Months|Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm).|||percentage of participants|||Number
2827055|NCT00325039|Secondary|Patient Satisfaction at 12 Months|"Patient satisfaction was assessed at the 12 month visit with the questions, how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage? Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as satisfied and neutral, most dissatisfied and completely dissatisfied as not satisfied."|Follow-Up|This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm)|||percentage of participants analyzed|||Number
2827056|NCT00325039|Primary|Objective Treatment Success at 12 Months|"Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures~A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs."|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively).|||percentage of participants|||Number
2827057|NCT00324987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 7 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
2827058|NCT00324987|Secondary|Central-review Based Progression-free Survival (CRb-PFS)|From date of registration (defined as date of randomization) to date of first documentation of one of the following events: death; first documentation of progression based on central review of the appropriate computed tomography (CT) or magnetic resonance imaging (MRI) scans; development of new lesions or disease not identified on CT or MRI; or symptomatic deterioration. Patients not experiencing any of these events will be censored at last date of contact.|up to 7 years|Data not collected as study accrued only 2% of the 572 patients planned. No scientific conclusions were forthcoming because of the small number of patients entered in the study.||||||
2827059|NCT00324987|Secondary|Overall Survival|From date of registration (defined as date of randomization) to date of death due to any cause. Patients last known to be alive are censored at last date of contact. Note: median was not reached in the Imatinib arm due to limited follow-up data.|up to 7 years|No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||months||95% Confidence Interval|Median
2827060|NCT00324987|Primary|Progression Free Survival|From date of registration (defined as date of randomization) to date of first observation of progressive disease, death due to any cause or symptomatic deterioration. Patients last known to be alive and progression free are censored at last date of contact. Progression is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), provided at least one target lesion does NOT demonstrate uniform hypoattenuation over > 90% of maximal cross sectional area; unequivocal progression of non-measurable disease; appearance of new lesion/site that is not uniformly hypoattenuating; a hyperattenuating region within a previously cystic/uniformly hypoattenuating lesion will be considered progressive disease if hyperattenuating region is either >= 1 cm in longest diameter or round/oval and forms acute margins with border of target lesion; death due to disease.|Up to 7 years|No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||months||95% Confidence Interval|Median
2827139|NCT00324259|Secondary|Frequency of Response to Re-treatment With the Same Aromatase Inhibitor That Immediately Preceded Treatment With Estradiol on Protocol.|Best overall response|12 weeks post-treatment termination|Only offered to patients experiencing clinical benefit on estradiol.|||participants|||Number
2827061|NCT00324987|Secondary|Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 7 years|Only eligible and evaluable patients included. No scientific conclusions were forthcoming because of the small number of patients entered in the study.|||Participants|||Count of Participants
2827062|NCT00324961|Secondary|Time to Protocol-defined Complete Response Over a 104-week Treatment Period|Time to response was defined as the time to participants achieving protocol-defined complete response at week 104 from baseline. Protocol-defined complete response was an HBV DNA level ≤ 300 copies/mL by Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Baseline to Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||days||Standard Deviation|Mean
2827063|NCT00324961|Secondary|Number of Participants Achieving Complete Response at Week 104|Complete response was defined as an HBV DNA level ≤ 300 copies/mL by the Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
2827064|NCT00324961|Secondary|Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. Missing data were not included in statistical analysis.|||participants|||Number
2827065|NCT00324961|Secondary|Number of Participants With ADV-associated Resistance at Week 104|Week 104 serum samples from participants who reached a HBV DNA breakthrough were assessed for the development of ADV (Adefovir dipivoxil) mutations (N236T and A181V) in the HBV polymerase. HBV DNA breakthrough was defined as an increase in HBV DNA level by 1 log10 copies/mL or more from the treatment nadir during Weeks 0 to 104.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.|||participants|||Number
2827066|NCT00324961|Secondary|Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104|HBsAg loss and HBsAg seroconversion (HBsAg loss and HBsAb detected) were assessed for all participants who were HBeAg negative at Weeks 0 and 104. Confirmed HBsAg loss was defined as undetectable HBeAg.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once|||participants|||Number
2827067|NCT00324961|Secondary|Number of Participants Achieving ALT Normalization at Week 104|Serum alanine aminotransferase (ALT) normalization was defined as a serum ALT level at or below the upper limit of the normal (ULN) range after a baseline value above the ULN, as determined using central laboratory ranges.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once. A total of 435 participants had a baseline ALT value above the ULN.|||participants|||Number
2827068|NCT00324961|Secondary|Change From Baseline in Median Serum HBV DNA Over Time|The HBV DNA level was tested in blood serum by real-time PCR with the LLD as 300 copies/mL at baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 in a central laboratory.|Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once.|||log10 copies/mL||Full Range|Median
2827069|NCT00324961|Secondary|Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks|The Knodell/histological activity index (HAI) scoring system that represents the sum of scores for periportal bridging necrosis (0-10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0-4: none=0, marked=4); portal inflammation (0-4: none=0, marked=4) and fibrosis (0-4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two independent pathologists in the HBeAg negative participants with 2 sequential liver biopsies during the period of 104 weeks.|Baseline to Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 48|||Points on a scale||Standard Deviation|Mean
2827070|NCT00324961|Secondary|Number of Participants Achieving Histological Improvement After the 104-week Treatment|Histological improvement (defined as ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was assessed by 2 independent pathologists in the HBeAg-negative participants who underwent 2 sequential liver biopsies at baseline and week 104/withdrawal. The Knodell/histological activity index (HAI) scoring system represents the sum of scores for periportal, bridging necrosis (0-10: none=0, multilobular necrosis=10), interlobular degeneration and focal necrosis (0-4: none=0, marked=4), portal inflammation (0-4: none=0, marked=4), and fibrosis (0-4: none=0, cirrhosis=4)|Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 104|||participants|||Number
2827071|NCT00324961|Primary|Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg participants who actually received the study medication at least once. Participants with missing data were not included in the analysis.|||participants|||Number
2827072|NCT00324896|Secondary|WASO|Wake after sleep onset in minutes|6 weeks|intent to treat|||minutes||Standard Deviation|Mean
2827073|NCT00324896|Primary|TST|Total sleep time in hours|6 weeks|intent to treat approach|||hours||Standard Deviation|Mean
2827074|NCT00324870|Other Pre-specified|Clinical Response Rate of SAHA and Bevacizumab|To determine the clinical response rate of SAHA and Bevacizumab in patients with metastatic renal cell carcinoma.|7 years|||||||
2827075|NCT00324870|Other Pre-specified|Maximum Tolerated Dose|Determine the maximum tolerated dose of SAHA|18 months from first patient dosing|||||||
2827205|NCT00323635|Secondary|Whether She Used Any Pads.|Yes/No|Duration of Study|No data collected or analyzed for the outcome measures.||||||
2827076|NCT00324870|Primary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)|Estimated by Kaplan-Meier method|At 6 months|Progression free survival was summarized for the entire sample (n=37). The median survival times and 6-month survival rates are estim. based on the KP curve,w/ corresp. 95% confidence intervals using the log-log method. Conducted in SAS v9.3(Cary, NC). Progr.free survival time is calc. from date of first tx until date of progres./death or last fu.|||percent||95% Confidence Interval|Number
2827077|NCT00324857|Secondary|To Examine and Compare the Effectiveness of the Proposed Intervention Strategies to Increase AA Patient Likelihood of Receiving Knee Replacement Within 12 Months of the Intervention.||12 months|The data were not collected and therefore not analyzed.||||||
2827078|NCT00324857|Primary|Change in Willingness.|"Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from definitely not willing to definitely willing which was later dichotomized for analysis. Responses definitely and probably willing were combined and compared to unsure, probably not willing, and definitely not willing combined."|Follow-Up|Study sample reflects the African American, predominantly male population of the VA health care system|||participants|||Number
2827079|NCT00324805|Other Pre-specified|To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB - IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting.||From registration to death, up to 10 years|Data were not collected||||||
2827080|NCT00324805|Other Pre-specified|Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC.||From registration to death, up to 10 years|Data for these studies were not collected||||||
2827081|NCT00324805|Other Pre-specified|Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|If the difference in the rate of a particular category of toxicities between the 2 arms (N=750 per arm) is at least 5% (4% vs. 9%), 96% power can be attained assuming a significance level of 5% (two-sided Chi Square test) and that the lower toxicity rate for one arm is 4%. A difference in the rates of grade 3-5 arterial thromboembolic events and bleeding events will be monitored and assessed between the treatment arms.|Up to 1 year post-treatment|||||||
2827082|NCT00324805|Secondary|Disease-free Survival|Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment.|From registration to death, up to 10 years|All enrolled patients|||months||95% Confidence Interval|Median
2827083|NCT00324805|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint.|From registration to death, up to 10 years|All enrolled patients|||months||95% Confidence Interval|Median
2827084|NCT00324753|Primary|Communication Content|PCP Explains CRC screening to my satisfaction|immediately after the patient visit||||Participants|||Count of Participants
2827085|NCT00324753|Primary|Quality of Communication|Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).|immediate after the patient visit||||Participants|||Count of Participants
2827086|NCT00324753|Primary|Completion of Colorectal Cancer Screening Tests|A survey collected data on patient demographic characteristics, family history of colorectal cancer or polyp, and provider recommendation for colorectal cancer screening, if any. In addition, we asked patients whether colorectal cancer screening was discussed at the visit. If the response was yes, we then asked patients how satisfied they were with the PCP communication during the visit in general using a 5-point Likert scale to a number of items describing the communication. A medical record review was conducted to collect data on provider ordering and patient completion of the following colorectal cancer screening tests during the study period (i.e., 6 months from the time of the clinical encounter): fecal occult blood testing, sigmoidoscopy, or colonoscopy.|6-12 months||||Participants|||Count of Participants
2827087|NCT00324740|Primary|Objective Response Rate|The phase II portion of the study ended early therefore the primary outcome of the objective response rate was not assessed.|Tumor measurements every 8 weeks until disease progression|||||||
2827088|NCT00324740|Primary|Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin|Hematologic: Any Grade 3/4 Thrombocytopenia and/or Grade 3/4 Neutropenia Non-Hematologic: Any >/= Grade3 non-hematologic toxicity considered by the investigator to be possibly related to study drug and/or any non-hematologic toxicity that results in a dose-delay of more than three weeks.|Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD).|The recommended phase II dose is vorinostat (300 mg bid) + Isotretinoin (0.5 mg/kg PO bid) three days per week|||mg/kg BID|||Number
2827089|NCT00324740|Primary|Dose Limiting Toxicities Associated With Vorinostat Concurrently Administered With Isotretinoin|Defined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Course 1, up to 28 days||||participants|||Number
2827090|NCT00324701|Secondary|SCID: Structured Clinical Interview for the DSM-IV|Structured clinical interview for the DSM-IV (SCID) administered by raters blind to subject condition. Structured interviews included psychiatric assessment for depression, PTSD, panic, generalized anxiety disorder (GAD) evaluated using the DSM-IV.|12 months|Participants completing 12 month assessment|||% participants with treatment response||95% Confidence Interval|Number
2827091|NCT00324701|Primary|At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)|The Geriatric Depression Scale (GDS) is a 30-item self-report assessment designed specifically to identify depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past week. Higher scores indicate more severe depression.|8 week & 12 months|Participants completing 8 week and 12 month assessments.|||% participants with treatment response||95% Confidence Interval|Number
2827092|NCT00324675|Secondary|HbA1c||at baseline and after 6 and 12 mo|||||||
2827093|NCT00324675|Secondary|Adverse Event||every month or at occurence|||||||
2827098|NCT00324649|Secondary|Percentage of Participants With Any Adverse Event|"Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.~Treatment-emergent adverse events were events that met one of the following criteria:~Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.~Had no recorded start date."|72 weeks|Treated participants.|||Percentage of participants|||Number
2827099|NCT00324649|Secondary|Change From Baseline in Waist Circumference/Hip Circumference Ratio|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded. Assessment of waist and hip circumference was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.|||Ratio||Inter-Quartile Range|Median
2827100|NCT00324649|Secondary|Percent Change From Baseline in Hematocrit|Change = Week 48 value minus baseline value expressed as median percent change.|Baseline to Week 48|Treated participants. Missing values were excluded.|||Percent change in hematocrit||Inter-Quartile Range|Median
2827101|NCT00324649|Secondary|Change From Baseline in Hemoglobin|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||g/dL||Inter-Quartile Range|Median
2827102|NCT00324649|Secondary|Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
2827103|NCT00324649|Secondary|Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
2827104|NCT00324649|Secondary|Change From Baseline in Fasting Total Cholesterol|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
2827105|NCT00324649|Secondary|Change From Baseline in Fasting Serum Triglycerides|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mg/dL||Inter-Quartile Range|Median
2827106|NCT00324649|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||cells/mm^3||Inter-Quartile Range|Median
2827107|NCT00324649|Secondary|Percentage of Participants With Virologic Failure|Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL.|48 weeks|Treated participants.|||Percentage of participants|||Number
2827108|NCT00324649|Secondary|Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL||48 weeks|Treated participants.|||Percentage of participants|||Number
2827109|NCT00324649|Secondary|Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL||48 weeks|Treated participants. Missing values were treated as failure (i.e., as HIV-1 RNA greater than or equal to 50 copies/mL).|||Percentage of participants|||Number
2827110|NCT00324649|Secondary|Percentage of Days for Which Participants Were Compliant With Study Drug|Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated.|Baseline to Week 72|Treated participants.|||Percentage of days with compliance||Inter-Quartile Range|Median
2827111|NCT00324649|Secondary|Change From Baseline in Lactate Concentration|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||mmol/L||Inter-Quartile Range|Median
2827112|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
2827113|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
2827114|NCT00324649|Primary|Change From Baseline in Limb Fat at Week 48|Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Number of participants analyzed is those with baseline and post-baseline DEXA data. Last post-baseline observation carried forward (LOCF) method was used if the Week 48 limb fat value was missing.|||grams (g)||Inter-Quartile Range|Median
2827115|NCT00324415|Secondary|Objective Response Rate (Complete and Partial)|Number of participants with complete and partial responses based on the RECIST criteria|3 years following treatment discontinuation||||participants|||Number
2827116|NCT00324415|Secondary|Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology||6 months following treatment discontinuation|||||||
2827117|NCT00324415|Secondary|Incidence of Opportunistic Illnesses|Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment|1 year following treatment discontinuation||||participants|||Number
2827118|NCT00324415|Secondary|Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment|Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment|1 year following treatment discontinuation|The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion|||cells/mm3||Full Range|Median
2827119|NCT00324415|Secondary|Toxicity|Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion|90 days following treatment discontinuation||||events|||Number
2827120|NCT00324415|Secondary|Quality of Life|EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life|1 year|The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year.|||units on a scale||Standard Deviation|Mean
2827124|NCT00324415|Secondary|Progression-free Survival|Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions.|1 year||||percentage of participants||95% Confidence Interval|Number
2827125|NCT00324415|Primary|Local Failure Rate at 3 Years|Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders|3 years following treatment discontinuation||||participants|||Number
2827126|NCT00324350|Secondary|Number of Participants With > 2 cm of Height Loss|Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing >2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity|5 years|Among participants in the BONE ancillary study, 6,979 participants had at least one height measurement during follow-up and were included in these analyses.|||participants|||Number
2827127|NCT00324350|Primary|Number of Participants With at Least One Fall|"At each annual visit starting in January 2006, participants were also asked about falling: In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair? Those who answered yes were also asked how many times they had fallen in the previous 12 months."|Average follow-up of 2.0 years|These analyses include results from the annual visits that occurred before Feb 5, 2008, the close of the intensive glycemia arm. Of those in the BONE ancillary study, 6,782 participants answered at least one question about falls.|||participants|||Number
2827128|NCT00324350|Primary|Number of Participants With at Least One Non-vertebral Fracture|The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.|Average follow-up of 3.8 years|As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended.|||participants|||Number
2827129|NCT00324272|Secondary|Death.|Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident).|From day of surgery until end of study follow-up period (1st June 2010)||||Participants.|||Number
2827130|NCT00324272|Secondary|Disease Recurrence.|This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010).|From date of surgery until end of study follow-up period (1st June 2010)||||Participants.|||Number
2827131|NCT00324272|Secondary|Post Operative Pain Score Measured on 1st Post-operative Day.|Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record.|During the immediate post-operative period.||||Units on a scale.||Inter-Quartile Range|Median
2827132|NCT00324272|Secondary|Number of Patients With Post-operative Complications (Excluding Lymphoedema).|Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded.|Until wound healing complete.||||Participants|||Number
2827133|NCT00324272|Secondary|Length of Time Drains Remain in Situ.|The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery until date of wound drain removal.||||Days||95% Confidence Interval|Median
2827134|NCT00324272|Secondary|Length of Hospital Inpatient Stay.|The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.|From date of surgery until date of discharge from hospital.|As the length of hospital stay was affected by numerous factors other than those related to the surgery itself (e.g. the patient's social circumstances), the results for this secondary outcome measure have not been presented.|||Days||Standard Deviation|Mean
2827135|NCT00324272|Primary|Post-operative Wound Drainage.|The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery to date of wound drain removal (typically a period of approximately one week).||||ml||95% Confidence Interval|Median
2827136|NCT00324259|Post-Hoc|Metabolic Flare on FDG-PET/CT as Compared to Response||Baseline and 24 hours after administration of the first dose of estradiol|"The data was combined as the outcome was not based on comparison of the two groups but comparing the overall FDG-PET/CT metabolic flare to the overall responses.~10 participants were not evaluable because early toxicity prevented response assessment and the PET data was not considered technically adequate or not available in 8 participants."|||participants|||Number
2827137|NCT00324259|Secondary|Overall Survival (OS)||Until patient death|This outcome measure was not analyzed as the overall survival was not reported.||||||
2827138|NCT00324259|Secondary|Frequency of Response to Re-treatment With Estradiol for Patients Who Have a Secondary Response to an Aromatase Inhibitor After the First Response to Estradiol.||Every 3 months|At the time that the study was powered there was not any information on any patients who were re-treated with estradiol after having a secondary response to a aromatase inhibitor after the first response to estradiol.||||||
2827140|NCT00324259|Secondary|Quality of Life (FACT-B Mean Score)|"Surveyed using the multidimensional Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire~The FACT-B (version 4) questionnaire consists of 36 items with five-point scale, ranging from 0-4, where a total score ranges from 0-144 and higher scores indicate better QoL. The total FACT-B score is the sum of scores for five subscales including: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and specific breast cancer concerns (9 items)."|Day 28|25 out of 34 participants in Arm 1 and 23 out of 32 participants completed the FACT-B questionnaire at Day 28 (4 weeks).|||units on a scale||Standard Deviation|Mean
2827141|NCT00324259|Secondary|Quality of Life|"Surveyed using a 6 item estrogen adverse effect questionnaire (headaches, bloating, breast tenderness, retention of fluid, nausea, and vomiting).~Used a 5-point scale ranging from 0 (not at all) to 4 (very much).~The scores from the 6 estrogen adverse effect items were summed to produce a single score, ranging from 0-24, with higher scores indicating higher adverse effects."|Baseline and Day 28|27 out of 34 participants in Arm 1 and 22 out of 32 participants in Arm 2 completed both the baseline and Day 28 (4 week) 6 item adverse effect questionnaire.|||units on a scale||Standard Deviation|Mean
2827142|NCT00324259|Secondary|Progression-free Survival (PFS)|"Defined as the time from treatment initiation to disease progression or death.~Time of last observation for patients remaining in the study and the time at which dose reductions, study drug termination, and withdrawal of consent occurred were treated as censored data.~Indicated as number of participants who had not progressed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.~Progression per RECIST 1.0 = at least a 20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Up to 48 weeks||||participants|||Number
2827143|NCT00324259|Primary|Clinical Benefit Rate (CR Plus PR Plus SD)|"Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0~CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter~SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease~SD is defined as lack of disease progression by 24 weeks."|24 weeks after start of treatment||||participants|||Number
2827144|NCT00324233|Secondary|Subjectively Measured Insertion of the Catheter|||||||||
2827145|NCT00324233|Secondary|Subjectively Measured Handling|||||||||
2827146|NCT00324233|Primary|Residual Urine Measured by Ultra Sound||2||||ml||Standard Deviation|Mean
2827147|NCT00324168|Secondary|Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size|Best-spectacle visual acuity (BSCVA) at 3 months from enrollment is stratified by categories of infiltrate/scar size and examined by treatment arm|3 months from enrollment||||logMAR||Standard Deviation|Mean
2827148|NCT00324168|Secondary|Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth|BSCVA measured in logMAR will be examined by categories infiltrate depth (categorized by depth percentage) by mean and standard deviation as well as in a regression model.|3 months from enrollment||||logMAR||Standard Deviation|Mean
2827149|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group|Best spectacle-corrected visual acuity (BSCVA) for this subgroup analysis was measured in logMAR and then categorized by equivalent Snellen fractions|3 months from enrollment||||logMAR||Standard Deviation|Mean
2827150|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism|BSCVA measured in logMAR will be estimated by causative organism (either Nocardia spp, Streptococcus pneumoniae, Moraxella spp, or Pseudomonas aeruginosa). BSCVA will be examined for each causative organism by mean and standard deviation as well as in a regression model.|3 months after enrollment||||logMAR||Standard Deviation|Mean
2827151|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate|Best spectacle-corrected visual acuity (BSCVA) for this outcome is measured in logMAR (logarithm of the Minimum Angle of Resolution) in which smaller values indicate better visual acuity. Minimum inhibitory concentration (MIC) to moxifloxacin was measured by E test and a log2-transformation of MIC was used in all analyses. In this analysis we add MIC to the model examining BSCVA at 3 months.|3 months after enrollment|The study population analyzed for this outcome includes only those study subjects for whom an MIC value was available.|||logMAR||95% Confidence Interval|Mean
2827152|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|12 months from enrollment||||logMAR||95% Confidence Interval|Mean
2827153|NCT00324168|Secondary|Ocular Perforations||At the time of perforation||||participants|||Number
2827154|NCT00324168|Secondary|Time to Resolution of Epithelial Defect|This outcome measured time from enrollment to resolution of the epithelial defect in days for up to 21 days. For three weeks patients were examined every 3 days for size of epithelial defect until the defect was gone.|From enrollment up to 21 days||||days||Standard Deviation|Mean
2827155|NCT00324168|Secondary|Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
2827156|NCT00324168|Secondary|Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment||3 months from enrollment||||mm||95% Confidence Interval|Mean
2827157|NCT00324168|Primary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
2827206|NCT00323635|Secondary|Hyperarousal|Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.|At baseline and 8 weeks later|No data collected or analyzed for the outcome measures.||||||
2827158|NCT00324155|Secondary|Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had a specific event that resolved|||Weeks||95% Confidence Interval|Median
2827159|NCT00324155|Secondary|Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had this specific event|||Participants|||Number
2827160|NCT00324155|Secondary|Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs|AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.|Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of randomized ipilimumab or placebo and/or dacarbazine|||Participants|||Number
2827161|NCT00324155|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.|Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months|All randomized participants whose survival follow-up was current (defined as having died or last known alive date occurring on or after the data cutoff date, which was when a total of 414 deaths occurred).|||Months||95% Confidence Interval|Median
2827162|NCT00324155|Secondary|Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff|Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.|Date of randomization up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
2827163|NCT00324155|Secondary|Duration of Stable Disease (SD): Randomized Participants With Stable Disease|Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.|Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had SD|||Months||95% Confidence Interval|Median
2827164|NCT00324155|Secondary|Time to Response: All Randomized Participants With Response to Treatment|Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.|First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and who had a response of CR or PR|||Months||Full Range|Median
2827900|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIA|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIA|||percentage of participants|||Number
2827165|NCT00324155|Secondary|Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)|DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.|Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had a response of CR, PR, irCR, or irPR. n=number of participants who responded by mWHO criteria and irRC.|||Months||95% Confidence Interval|Median
2827166|NCT00324155|Secondary|Best Overall Response Rate (BORR)|BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.|First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
2827167|NCT00324155|Secondary|Progression-free Survival (PFS) Rate Truncated at Week 12|PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators.|Day 78|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
2827168|NCT00324155|Secondary|Median Number of Months of Progression-free Survival (PFS)|PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions.|Randomization to date of progression or death to approximately 5 years|All participants who were randomized to a treatment group|||Months||95% Confidence Interval|Median
2827169|NCT00324155|Secondary|Disease Control Rate (DCR)|DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.|First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)|All participants who were randomized to a treatment group|||Percentage of participants|||Number
2827170|NCT00324155|Secondary|Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years|The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.|Date of randomization to 3 years following randomization|All participants who were randomized to a treatment group|||Percentage of participants||95% Confidence Interval|Number
2827171|NCT00324116|Secondary|Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).|Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, 54 weeks or at early termination|FAS; n=number of subjects with evaluable data.|||score on scale||Standard Deviation|Mean
2827172|NCT00324116|Secondary|Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)|"Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.~Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54."|54 weeks|FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)|||participants|||Number
2827173|NCT00324116|Secondary|Number of Subjects With Severe Visual Loss|Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS|||participants|||Number
2827174|NCT00324116|Secondary|Number of Subjects Maintaining Vision|Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS|||participants|||Number
2827175|NCT00324116|Secondary|Number of Subjects Gaining Vision|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS|||participant|||Number
2827176|NCT00324116|Secondary|Change From Baseline in Visual Acuity|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.|Baseline, 6 weeks, 12 weeks, 54 weeks|FAS; n=number of subjects with evaluable data.|||score on scale||Standard Deviation|Mean
2827177|NCT00324116|Primary|Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.|Baseline, 54 Weeks|The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.|||participants|||Number
2827178|NCT00324038|Primary|Average Daily Pain Scores - BS11 Pain Scores.|The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.|every day over a 12 week study duration.||||Box Scale 11 boxes||Standard Deviation|Mean
2827179|NCT00323882|Secondary|Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants|HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.|Day 1 up to 2 years|All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.|||participants|||Number
2827180|NCT00323882|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants|12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).|Baseline up to 2 years|All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.|||participants|||Number
2827181|NCT00323882|Secondary|Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Amylase U/L: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN. Creatinine µmol/L: Gr1: > 1.0 - 1.5*ULN; Gr2: > 1.5 - 3.0*ULN; Gr3: > 3.0 - 6.0*ULN; Gr4: > 6.0*ULN.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.|||participants|||Number
2827207|NCT00323635|Secondary|Cognitive Function|Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)|Two 20-minute sessions during 2 months|No data collected or analyzed for the outcome measures.||||||
2827182|NCT00323882|Secondary|Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. White blood cells(WBC) 10^9 cells per liter (c/L): Gr1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Lymphocytes (absolute) 10^9 c/L: Gr1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Neutrophils (absolute) 10^9 c/L: Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Platelets 10^9 c/L: Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.|||participants|||Number
2827183|NCT00323882|Secondary|Overall Survival at Completion of Follow Up Period - Treated Participants|Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.|Day 1 to 5 years post treatment|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.|||Months||95% Confidence Interval|Median
2827184|NCT00323882|Secondary|Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants|Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.|Day 1 to 5 years post treatment|Treated participants population included all participants in the study who received either ipilimumab or radiation.|||participants|||Number
2827185|NCT00323882|Primary|Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants|Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA < 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 85|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.|||participants|||Number
2827186|NCT00323882|Secondary|PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy|PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration < 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is < 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.|Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2827187|NCT00323882|Secondary|Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy|Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.|||percentage of participants||95% Confidence Interval|Number
2827188|NCT00323882|Secondary|Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85|Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.|Day 1 to Day 85|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab, had a baseline PSA, and had a confirmed Complete Response (CR) or Partial Response (PR) at Day 85.|||Months||Full Range|Median
2827208|NCT00323635|Secondary|Sleep Quality||2 months|No data collected or analyzed for the outcome measures.||||||
2827209|NCT00323635|Secondary|Quality of Life, Scores on the Women's Health Questionnaire.|Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.|2 weeks|No data collected or analyzed for the outcome measures.||||||
2827189|NCT00323882|Secondary|Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants|For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 to last day of study treatment (+70 days) up to 2 years|Tumor-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had measurable disease at baseline, were analyzed.|||participants|||Number
2827190|NCT00323882|Secondary|Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants|Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 1 to last day of study treatment (+70 days) up to 2 years|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.|||participants|||Number
2827191|NCT00323882|Primary|Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation were analyzed.|||participants|||Number
2827192|NCT00323869|Secondary|Overall Survival (OS) at 24 Months|Number of subjects surviving 2 years after treatment initiation|24 months|Includes all subjects who initiated treatment|||participants|||Number
2827193|NCT00323869|Secondary|Overall Survival (OS) at 12 Months|Number of subjects surviving 1 year after treatment initiation|12 months|Includes all subjects who initiated treatment|||participants|||Number
2827194|NCT00323869|Secondary|Time-to-First Event|Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation|18 months|Includes all subjects who initiated treatment|||months||95% Confidence Interval|Median
2827195|NCT00323869|Secondary|Stable Disease (SD)|Number of subjects with SD per RECIST criteria|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
2827196|NCT00323869|Secondary|Complete Response (CR)|Number of subjects with CR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
2827197|NCT00323869|Secondary|Partial Response (PR)|Number of subjects with PR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
2827198|NCT00323869|Secondary|Overall Survival (OS)|To evaluate the safety of the combination regimen.|36 months|Includes all subjects who initiated treatment|||months||95% Confidence Interval|Median
2827199|NCT00323869|Secondary|Response Rate (CR + PR + SD)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE~Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.~Complete Response (CR) = disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions~Stable Disease (SD): No significant effect, does not meet criteria for PR or PD."|6 weeks|Includes all subjects who initiated treatment|||participants|||Number
2827200|NCT00323869|Primary|Progression-free Survival (PFS)|Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.|18 months|Includes all subjects who initiated treatment|||months||Full Range|Median
2827201|NCT00323739|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||Months||95% Confidence Interval|Median
2827202|NCT00323739|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months||||Months||95% Confidence Interval|Median
2827203|NCT00323635|Other Pre-specified|Sleep / Wake Pattern|Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.|Two weeks|No data collected or analyzed for the outcome measures.||||||
2827204|NCT00323635|Secondary|Pads Used|Pads used|Duration of Study|No data collected or analyzed for the outcome measures.||||||
2827214|NCT00323635|Primary|Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;|Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.|2 months|No data collected or analyzed for the outcome measures.||||||
2827215|NCT00323622|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||Subjects|||Number
2827216|NCT00323622|Secondary|Number of Subjects With Anemia.|"Anemia was indicated by a hematocrit level (HL) below (<) 25%. The numbers of subjects with HL below (<) and above or equal (≥) 25 %, and with missing HL results were tabulated. In the tabulation below, the number of subjects falling into the HL ≥25% category corresponds to the number of subjects with anemia as asked per outcome. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges."|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||Subjects|||Number
2827217|NCT00323622|Secondary|Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)|PFMI was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The number of PFMI episodes (EPFMI) per person-year (pyr) was tabulated, using as unit EPFMI episode per pyr. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||EPFMI episode per pyr|||Number
2827218|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 3 was defined as the presence of P. falciparum asexual parasitaemia above 15000 per microliter (µL) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
2827219|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 2 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films in an unwell child brought for treatment with a history of fever (axillary temperature equal or above 37.5 degrees Celsius) within 24 hours or documented fever. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
2827229|NCT00323609|Secondary|Change in Posterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.|||mm|treated vertebrae|Standard Deviation|Mean
2827230|NCT00323609|Secondary|Change in Middle Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.|||mm|treated vertebrae|Standard Deviation|Mean
2827220|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 1 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
2827221|NCT00323622|Secondary|Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition|Malaria infection by Plasmodium falciparum was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).|||n/PYAR|||Number
2827222|NCT00323622|Secondary|Anti-hepatitis B (HBs) Antibody Concentrations.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). Anti-HBs antibody concentration levels were measured in blood samples from Cohort 2 only.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens,with blood sample within protocol-defined time limits and available antibody measurements.|||mIU/mL||95% Confidence Interval|Geometric Mean
2827223|NCT00323622|Secondary|Anti-circumsporozoite Protein (CS) Antibody Concentrations.|Concentrations for anti-CS antibodies are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 0.5 EL.U/mL. Subjects were pooled across age ranges for this outcome measure.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens, with blood sample within protocol-defined time limits and available antibody measurements|||EL.U/mL||95% Confidence Interval|Geometric Mean
2827224|NCT00323622|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the Total Vaccinated cohort, which included all subjects vaccinated in the primary NCT00197041 study, and re- enrolled in this follow-up NCT 00323622 study, and for whom data were available.|||Subjects|||Number
2827225|NCT00323609|Secondary|VCF-related Health Care Utilization|Health care utilization assessments conducted by monthly phone call to participating patients.|Monthly for 24 months post-op|Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.||||||
2827226|NCT00323609|Secondary|Change in Global Sagittal Balance.|Change in global sagittal balance as measured by sagittal vertical axis.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.||||||
2827227|NCT00323609|Secondary|Change in Vertebral Body Local Cobb Angle (LCA)|The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.|||degree|treated vertebrae|Standard Deviation|Mean
2827228|NCT00323609|Secondary|Change in Vertebral Body Kyphosis Angle|The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.|||degree|treated vertebrae|Standard Deviation|Mean
2827231|NCT00323609|Secondary|Change in Anterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.|||mm|treated vertebrae|Standard Deviation|Mean
2827232|NCT00323609|Secondary|Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days|Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.|||percentage of participants|||Number
2827233|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months||24 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.|||percentage of participants|||Number
2827234|NCT00323609|Secondary|Rate of Serious Adverse Events at 30 Days|Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.|||percentage of participants|||Number
2827235|NCT00323609|Secondary|Quality of Life -- EQ5D Index|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
2827236|NCT00323609|Secondary|Quality of Life by SF-36|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
2827237|NCT00323609|Secondary|Back Function-Oswestry Disability Index|The Oswestry Disability Index (ODI) Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
2827238|NCT00323609|Secondary|Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|7 days, 30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.|||units on a scale||Standard Deviation|Mean
2827239|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months||12 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.|||percentage of participants|||Number
2827240|NCT00323557|Primary|Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine|Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of >0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.|Baseline and at 1 month after vaccine.||||participants|||Number
2827241|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48||48 weeks|ITT. Missing values were treated as failure.|||Percentage of participants|||Number
2827242|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12||12 weeks|ITT. Missing values were excluded. Any subjects with plasma HIV-1 RNA greater than or equal to 400 copies/mL at Week 12 were to have virologic genotyping performed.|||Percentage of participants|||Number
2827243|NCT00323492|Secondary|Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12||12 weeks|ITT. Missing values were treated as failure.|||Percentage of participants|||Number
2827244|NCT00323492|Secondary|Change From Baseline to Week 48 in CD4 Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|ITT. Missing values were excluded.|||cells/mm^3||Inter-Quartile Range|Median
2827245|NCT00323492|Secondary|Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count|Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||cells/mm^3||Inter-Quartile Range|Median
2827246|NCT00323492|Secondary|Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12|Centralized laboratory assessment|12 weeks|ITT. Missing values were excluded.|||Percentage of participants|||Number
2827268|NCT00323414|Secondary|Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values|Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.|48 weeks||||HOMA-IR index||Standard Deviation|Mean
2827247|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)|Local laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded. Assessment of us-CRP was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.|||mg/L||Inter-Quartile Range|Median
2827248|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
2827249|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||Ratio||Inter-Quartile Range|Median
2827250|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||mmol/L||Inter-Quartile Range|Median
2827251|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.|||mmol/L||Inter-Quartile Range|Median
2827252|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.|||mmol/L||Inter-Quartile Range|Median
2827253|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Triglycerides|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.|||mmol/L||Inter-Quartile Range|Median
2827254|NCT00323479|Secondary|Percentage of Participant With Therapeutic Maintenance Under Anastrozole|Treatment compliance. results based on 109 patients due to missing values|12 months||||percentage of participants|||Number
2827255|NCT00323479|Secondary|Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole|X ray assessment on hands and wrists based on 99 patients due to missing values|12 months||||millimeter||Standard Deviation|Median
2827256|NCT00323479|Secondary|Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole|X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values|12 months||||Units on scale||Standard Deviation|Mean
2827257|NCT00323479|Secondary|Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole|Results are based on 97 patients due to missing values|12 months||||Ng/mL||Standard Deviation|Mean
2827258|NCT00323479|Secondary|Functional Index of Cochin at 12 Months in Patients Under Anastrozole.|Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.|12 months||||Units on scale||Standard Deviation|Mean
2827259|NCT00323479|Primary|Number of Participants With New Events of Arthralgia||12 months||||Participants|||Number
2827260|NCT00323453|Primary|Post-operative Wound Infection, After Open Appendectomy|Wound infections will be documents in both the traditional retraction arm and the wound protections device arm. The severity of appendicitis between the two groups will be matched.|21 post operative days||||Participants|||Count of Participants
2827261|NCT00323427|Primary|Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Non-verbal Strategies subscale describe adaptive coping strategies but they describe unobtrusive, nonverbal behaviors that the individual can use to maximize communication effectiveness.~8 week change score from baseline value.~Larger values of the change score indicate more use of adaptive non-verbal behaviors.~Larger group mean change score indicates BETTER performance on this scale.~The CPHI Non-verbal strategies score ranges from 1 (worse) to 5 (better) usage of non-verbal strategies."|8-weeks post-baseline relative to baseline|Intent-to-Treat|||score on a scale.||Standard Deviation|Mean
2827262|NCT00323427|Primary|Communication Profile for Hearing Impaired: Verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Verbal Strategies subscale describe adaptive strategies for coping with the effects of hearing impairment on communication.~8 week change score from baseline value.~Larger values of the change score indicate more use of adaptive Verbal Strategies.~Larger group mean change score indicates BETTER performance on this scale.~CPHI Verbal Strategies scores vary from 1 (worse) to 5 (best) strategy usage."|8 weeks post-baseline relative to baseline|Intent to treat|||score on a scale||Standard Deviation|Mean
2827263|NCT00323427|Primary|Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems.~8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale.~CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage."|8 weeks post-baseline relative to baseline|Intent-to-treat (ITT)|||score on a scale||Standard Deviation|Mean
2827264|NCT00323414|Secondary|HbA1C Levels|Hemoglobin A1c|48 weeks||||mg/dL||Standard Deviation|Mean
2827265|NCT00323414|Secondary|Blood Glucose Levels|Fasting blood glucose|48 weeks||||mg/dL||Standard Deviation|Mean
2827266|NCT00323414|Secondary|Alanine Amino Transferase (ALT) Levels|Alanine amino transferase (IU/dL) ay 48 weeks|48 weeks||||IU/dL||Standard Deviation|Mean
2827267|NCT00323414|Secondary|Aspartate Amino Transferase (AST) Levels|Aspartate amino transferase (IU/dL) at 48 weeks|48 weeks||||IU/dL||Standard Deviation|Mean
2827901|NCT00319735|Secondary|Perform Exploratory Molecular Correlates.|To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.|36 months|No data was collected or analyzed for this secondary objective.||||||
2827269|NCT00323414|Primary|Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS)|The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) is a score based on the liver biopsy. It represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8, with high scores indicating more activity.|48 weeks||||Participants|||Count of Participants
2827270|NCT00323362|Secondary|1-year Survival|Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.|3 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.|||percentage of patients|||Number
2827271|NCT00323362|Secondary|Time to Progression||2 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.|||months||Standard Deviation|Mean
2827272|NCT00323362|Primary|Percentage of Patients Who Meet Critieria for Response|"Response is considered Partial Response or Complete Response as per RECIST criteria.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years|Fourteen subjects were evaluable for response. Three subjects were not assessed.|||percentage of patients who responded|||Number
2827273|NCT00323310|Primary|The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events||up to 72 hours post dose|Included all dosed patients (safety population).|||Participants|||Number
2827274|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827275|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827276|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827277|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827278|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827287|NCT00323297|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class.|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the LOCF approach.|||Participants|||Number
2827279|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827280|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827281|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827282|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.|||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
2827283|NCT00323297|Secondary|One Year Survival From the Start of Sildenafil Treatment.|The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.|||Participants who died|||Number
2827284|NCT00323297|Secondary|One Year Survival Probability From the Start of Sildenafil Treatment.|The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.|||Probability of death||90% Confidence Interval|Number
2827285|NCT00323297|Secondary|Change From Baseline in Borg Dyspnea Score at Week 12|"Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);~(very slight);~(slight breathlessness);~(moderate); 4 (some what severe);~5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum)."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach.|||Units on a scale||Standard Deviation|Mean
2827286|NCT00323297|Secondary|Clinical Worsening Events|"No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead.~Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication.|||Participants|||Number
2827302|NCT00323115|Secondary|Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Mean|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as mean.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||spots||Standard Deviation|Mean
2827288|NCT00323297|Primary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12|6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Week 12|Intent-to-Treat (ITT) Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward (LOCF) approach. Statistical analysis was carried out on LOCF values.|||Meters||Standard Deviation|Mean
2827289|NCT00323284|Secondary|Efficacy|Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months|12 months|Intent to treat population using non-responder approach|||percent||95% Confidence Interval|Number
2827290|NCT00323284|Primary|Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds|Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months|12 months|Intent to treat analysis of all enrolled subjects using non-responder approach|||percent of subjects achieving endpoint||95% Confidence Interval|Number
2827291|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|Baseline to Post Treatment (12 weeks)|Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|||units on a scale||Standard Deviation|Mean
2827292|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|baseline||||units on a scale||Standard Deviation|Mean
2827293|NCT00323258|Secondary|Death in Intervention Patients Compared to Usual Care|Number of patients who died in each treatment group prior to the 6 month follow-up time point.|6 months||||participants|||Number
2827294|NCT00323258|Secondary|Percent of Patients Adherent to Statin Via Refill Records|"According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.~% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.|||percentage of patients with >or=75%|||Number
2827295|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker Via Refill Records|"According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.~% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.|||percentage of patients with PDC >or=75%|||Number
2827296|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records|Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.|||percentage of participants|||Number
2827297|NCT00323258|Primary|Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months|Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist|6 months|Those participants alive and able to speak to pharmacist on 6 month follow up phone call. Missing (n=35)- Could not be reached: 12 intervention and 11 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Died during call period: 2 intervention and 1 usual care, refused to participate in call: 1 intervention and 5 usual care.|||percentage of participants|||Number
2827298|NCT00323193|Secondary|Impact of Weight on Quality of Life Survey (IWQOL)|Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.|baseline and six months||||units on a scale||Standard Deviation|Mean
2827299|NCT00323193|Primary|Weight Measurement|Weight taken at the baseline assessment and again at the 6 month assessment|baseline and six months||||pounds||Standard Deviation|Mean
2827300|NCT00323115|Secondary|Immunohistochemistry|"Pathologic specimen obtained from patients who require of another surgical resection after vaccination will be examined to determine the characteristics of infiltrating tumor cells.~Paraffin sections of tumor specimen will be stained by immunohistochemistry with antibodies to identify the components of the inflammatory response. This specimen will be compared to the one obtained at the time of initial surgery and changes in inflammation and inflammatory cellular components will be noted."|Approximately 42 months|Number of patients with pre- and post-tumor tissue procured, to undertake a meaningful analysis of the tumor immunohistochemistry slides inflammatory cells was insufficient. No data was collected.||||||
2827301|NCT00323115|Secondary|Evaluation of T Cell Characteristics|Peripheral blood obtained before starting radiation/ temozolomide (TMZ), and at first and second leukapheresis will be used to do lymphocyte phenotyping. We will determine percentages of CD3+/CD8+/CD45RO+ (memory T-cells), CD3+/CD8+/CD28- (CD8 suppressor T cell phenotype), and CD4+/CD25+ cells at those 3 time points. An anti-human Foxp3 antibody will be used to determine if the CD4+/CD25+ cells are T regulatory cells (TREG) and how the compartmental shift correlates with immunoresponse by other immune parameters as well as to efficacy.|Before starting radiation/Temozolomide and at Day 7 and Day 42.||||percentage of cells||Standard Deviation|Mean
2827303|NCT00323115|Secondary|Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Mean|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as median. IFN = interferon.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||percentage of cells||Standard Deviation|Mean
2827304|NCT00323115|Secondary|Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Mean|Pre- and post-vaccine immune assay results (Tumor-specific T-cells ) are summarized on a continuous scale as mean.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)|proportion of cells responding to GBM; GBM = glioblastoma multiforme|||proportion of cells||Standard Deviation|Mean
2827305|NCT00323115|Secondary|Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Median|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as mean.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||spots||Full Range|Median
2827306|NCT00323115|Secondary|Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Median|Pre- and post-vaccine immune assay results (Tumor-specific T-cell Responses) are summarized on a continuous scale as median.|Day 7 (pre-vaccination) and Day 42 (post-vaccination)||||percentage of cells||Full Range|Median
2827307|NCT00323115|Secondary|Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Median|Pre- and post-vaccine immune assay results (Tumor-specific T-cells ) are summarized on a continuous scale as median.|Day 7 (pre-vaccination) and Day 42 (post-vaccination).|proportion of cells responding to GBM; GBM = glioblastoma multiforme|||proportion of cells||Full Range|Median
2827308|NCT00323115|Secondary|Overall Survival Duration: Efficacy Parameters|Overall survival will also be followed. Survival will be assessed from the date of surgery to the date of patient death, due to any cause, or to the last date the patient was known to be alive.|Approximately 42 months|There were 4 patients alive when data collection ended, including the patient the longest overall survival.|||Months||Full Range|Median
2827309|NCT00323115|Secondary|Number of Participants With Significant Difference in Tumor Volume Size Pre- and Postvaccination: Neuroimaging and Tumor Assessment|Patients with evidence of evaluable enhancing disease on contrast-enhanced MRI performed within four weeks of study entry will be evaluated for response rate. Patients will be evaluated for objective tumor assessments by gadolinium-enhanced magnetic resonance imaging (Gd-MRI). Comparisons of objective assessments, excluding progressive disease, are based upon major changes in tumor size on the Gd-MRI compared to the baseline scan. Determination of progressive disease is based upon comparison to the previous scan with volumetric analysis.|baseline and 4 weeks||||Participants|||Count of Participants
2827310|NCT00323115|Secondary|Progression Free Survival (PFS)|Progression-free survival will be assessed for each patient as the time from surgery until the patient reaches objective disease progression by MRI criteria. Death will be regarded as a progression event in those patients that die before disease progression. Patients without documented objective progression at the time of the analysis will be censored at the date of their last objective tumor assessment. Since disease free survival and overall survival are secondary endpoints all patients will be followed until death or for a period of 5 years following enrollment.|Approximately 42 months||||Months||Full Range|Median
2827311|NCT00323115|Secondary|Number of Participants With Evaluable Data: Feasibility of Vaccination|To determine the feasibility of this approach, the investigators hypothesize that at least 2/3 of the patients included in the study will be evaluable, meaning that the participants would have received the 3 vaccinations with immunologic outcome parameters measured before and after vaccination. Therefore a maximum of 15 patients would be enrolled in the study to obtain 10 evaluable patients. If after enrolling 15 patients the investigators are unable to obtain 10 evaluable patients, the investigators would consider this approach not feasible.|Through enrollment, approximately 2 years||||Participants|||Count of Participants
2827312|NCT00323115|Secondary|Number of Adverse Events: Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination|Adverse events attributed to vaccination. Collected and attributed adverse events at each study visit; monitored participants for adverse events for two hours following vaccination procedure.|Until death or approximately 24 months after diagnosis|Participants were monitored for adverse events at each visit and observed for 2 hours after intranodal injections. Toxicities were graded using the Common Terminology Criteria for Adverse Events (version 3.0) and Common Toxicity Criteria (version 3.0).|||attributable adverse events|||Number
2827313|NCT00323115|Primary|Tumor-specific Cytotoxic T-cell Response|MRI & pheresis post vaccine|Day 42|All participants who received all 3 vaccine administrations were used in this data analysis.|||10^9 cells/L||Full Range|Median
2827314|NCT00323063|Secondary|Overall Survival||5 years|This study was prematurely closed so overall survival was not analyzed.||||||
2827315|NCT00323063|Secondary|Response Rate (Complete and Partial Response)|Overall response rate was evaluated every 2 cycles (six weeks) for both groups using international criteria by the Response Evaluation Criteria in Solid Tumors (RECISTv1.0) for target lesions and were assessed by CT or MRI. Response rates were defined as complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response(OR) defined as OR=CR + PR|5 years||||percentage of participants||95% Confidence Interval|Number
2827316|NCT00323063|Primary|Time to Progression|Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).|5 years||||months||95% Confidence Interval|Median
2827317|NCT00323037|Secondary|Drug Compliance||Up to 32 weeks (titration and maintenance phases)|||||||
2827318|NCT00323037|Secondary|Safety and Tolerability of Coreg CR||24 weeks after entry into the maintenance phase (after unblinding)|||||||
2827319|NCT00323037|Secondary|Drug Dose Tolerability||Up to 32 weeks (titration and maintenance phases)|||||||
2827320|NCT00323037|Secondary|Hospitalizations From All Causes||Up to 32 weeks (titration and maintenance phases)|||||||
2827321|NCT00323037|Secondary|Incidence of Hospitalizations From Exacerbation of Heart Failure||Up to 32 weeks (titration and maintenance phases)|||||||
2827322|NCT00323037|Secondary|Change From Baseline in BNP Levels||24 weeks after entry into the maintenance period|||||||
2827325|NCT00323037|Primary|Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography|Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.|24 weeks after entry into the maintenance period|Analysis was performed on the modified intent to treat population (mITT), which were those subjects with both a Baseline and an evaluable End of Study echocardiogram.|||mL/m^2||Standard Deviation|Mean
2827326|NCT00322881|Primary|Therapy Completion Rate|The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.|6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
2827327|NCT00322868|Primary|Sputum IL-8|Concentration of Interleukin-8 log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
2827328|NCT00322868|Primary|Sputum IL-6|The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
2827329|NCT00322868|Primary|Sputum IL-1ß|The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
2827330|NCT00322868|Primary|Sputum TNFα|The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (pg/mL)||Standard Deviation|Mean
2827331|NCT00322868|Primary|Sputum Active Elastase|Log 10 of Concentration of active Elastase in mcg/mL|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (mcg/mL)||Standard Deviation|Mean
2827332|NCT00322868|Primary|Sputum Neutrophil Percent|Neutrophils as a percent of the total white cells.|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||Percent (%) of white blood cells||Standard Deviation|Mean
2827333|NCT00322868|Primary|Sputum Neutrophil Count|sputum neutrophils log 10 (cells/mL)|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (cells/mL)||Standard Deviation|Mean
2827334|NCT00322868|Primary|Sputum White Cell Count|The total number of white cells log 10 cells/mL|Day 0 and Day 29|Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples.|||log 10 (cells/mL)||Standard Deviation|Mean
2827335|NCT00322855|Primary|To Review the Outcome of Patients With Soft Tissue Sarcoma Treated With Chemotherapy From 2004 and 2005||up to one year|Study was terminated due to low accrual. This is not an applicable trial; no results to report||||||
2827336|NCT00322842|Secondary|Increase in Peripheral Blood (PB) CD34+ Cells From Steady-state Hematopoiesis to Pre-leukapheresis in G-CSF+Plerixafor Treated Participants Compared to Historical Controls Treated With G-CSF Alone or Chemotherapy and G-CSF|A comparison of the effectiveness in mobilizing peripheral blood CD34+ cells between this study's treatment regimen (G-CSF plus plerixafor) to other treatment options: G-CSF alone, and chemotherapy with G-CSF.|up to day 8|Analysis was not performed. Historical data was not available.||||||
2827337|NCT00322842|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who had transplants and engraftment data 12 months after transplantation|||participants|||Number
2827338|NCT00322842|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants.|||number of transplants|Participants||Number
2827339|NCT00322842|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.|||number of transplants|Participants||Number
2827340|NCT00322842|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis as measured by a central lab.|Days 5-8|Intent to treat population. Samples from two participants were not analyzed by the central lab.|||CD34+ cells (*10^6 / kg)||Full Range|Median
2827341|NCT00322842|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL After First Dose of Plerixafor|The fold increase was measured using local lab values and is the ratio of post first dose (pre-apheresis) PB CD34+ cells/µL)/pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population|||ratio||Full Range|Median
2827342|NCT00322842|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 step scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.|||participants|||Number
2827343|NCT00322777|Secondary|Remission|Remission of depression was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). Remission was based on a HAM-D score of less than 7. Remission is indicated as a percentage of participants at each time point whose scores were below 7.|baseline, 8 weeks, 16 weeks, and 24 weeks||||percentage of participants score < 7|||Number
2827344|NCT00322777|Secondary|Response Rate|Response rate was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). A response was determined as a reduction in the HAM-D score by at least 50% from the baseline score. The data are presented as the percentage of participants with response at each time point as compared to baseline.|baseline, 8 weeks, 16 weeks, and 24 weeks||||percentage of participants with response|||Number
2827345|NCT00322777|Primary|Hamilton Depression Rating Scale - Depression Severity|"Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. Total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression.~The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants' allocation."|baseline, 8 weeks, 16 weeks, and 24 weeks||||units on a scale||Full Range|Mean
2827346|NCT00322712|Primary|Time to Death|Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.|From date of treatment until time of death||||Months||Full Range|Median
2827347|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||kilograms (kg)||Standard Deviation|Mean
2827348|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||mm Hg||Standard Deviation|Mean
2827349|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||mm Hg||Standard Deviation|Mean
2827350|NCT00322621|Secondary|Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.|||beats per minute||Standard Deviation|Mean
2827351|NCT00322621|Secondary|Number of Participants Discontinuing in Maintenance / Rescue Phase||Baseline (Week 8) to Week 34|Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)|||participants|||Number
2827352|NCT00322621|Secondary|Number of Participants Discontinuing in the Acute Phase||Baseline (Week 0) to Week 8|Participants in Acute Phase (through Week 8).|||participants|||Number
2827353|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827354|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827355|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827356|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827357|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827358|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827359|NCT00322621|Secondary|Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827360|NCT00322621|Secondary|Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827361|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827362|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827363|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827364|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827365|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827366|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827367|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827368|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827369|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827370|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827371|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827372|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827373|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827374|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827375|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827376|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827377|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827378|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827379|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827380|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827775|NCT00320424|Secondary|Summary of Units Transfused|Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||mL|||Number
2827381|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827382|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827383|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827384|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827385|NCT00322621|Secondary|Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||participants|||Number
2827386|NCT00322621|Secondary|Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||participants|||Number
2827387|NCT00322621|Primary|Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint|Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2827388|NCT00322556|Primary|Number of Subjects With Clinically Significant Changes in Vital Signs.|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Before, during, and after each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.|||Participants|||Number
2827389|NCT00322556|Secondary|Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.|Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.|Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.|The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available.|||g/L||Full Range|Mean
2827390|NCT00322556|Secondary|Annualized Rate of Any Infection.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Infections were classified as all AEs with the system organ class infections and infestations and AEs with the preferred term conjunctivitis."|For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug.|||Infections per subject year|Participants||Number
2827391|NCT00322556|Secondary|Number of Days of Hospitalization.||For the duration of the study, up to approximately 29 months|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.|||Days||Full Range|Median
2827392|NCT00322556|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.||For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.|||Days||Full Range|Median
2827393|NCT00322556|Secondary|Annualized Rate of Acute Serious Bacterial Infections.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 29 months|The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug|||Infections per subject year|Participants||Number
2827394|NCT00322556|Primary|Rate of AEs by Severity and Relationship|"The AE rate was the number of AEs over the number of infusions administered.~Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs."|For the duration of the study, up to approximately 29 months|The SDS comprised all subjects treated with the study drug.|||AEs per infusion|Participants||Number
2827395|NCT00322556|Primary|Influence of Infusion Rate on Temporally-Associated AEs|"The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).~AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion."|Within 72 hours after each infusion|'New subjects’ could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 [study number ZLB03_002CR, NCT00168025]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator.|||Infusions|Participants||Number
2827396|NCT00322556|Primary|The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).|AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.|During each infusion, and within 48 or 72 hours after the end of each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.|||Proportion of infusions|Participants||Number
2827397|NCT00322491|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.|||participants|||Number
2827398|NCT00322491|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.|||number of transplants|Participants||Number
2827399|NCT00322491|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who received a transplant. Two participants in the MM group received a second transplant.|||number of transplants|Participants||Number
2827400|NCT00322491|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median cumulative total number of CD34+ cells collected during apheresis.|Days 5-8|Participants who received at least one dose of plerixafor|||CD34+ cells (*10^6 / kg)||Full Range|Median
2827401|NCT00322491|Secondary|Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor|The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).|||participants|||Number
2827402|NCT00322491|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population – all participants who received at least 1 dose of plerixafor.|||participants|||Number
2827403|NCT00322465|Secondary|Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis|Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis|Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|||||||
2827404|NCT00322465|Primary|Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.~Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).~Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo|||Percentage of participants|||Number
2827405|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
2827406|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
2827407|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset|At all study visits, unsolicited adverse events were recorded.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
2827408|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.|||Participants|||Number
2827409|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis|Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.|||Participants|||Number
2827410|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures.|||Participants|||Number
2827411|NCT00322465|Secondary|Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)|Baseline (enrollment)|All study participants with evaluable baseline test results.|||Percentage of participants|||Number
2827412|NCT00322465|Secondary|Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.|||Percentage of participants|||Number
2827413|NCT00322465|Secondary|Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.|||Percentage of participants|||Number
2827414|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.|||Percentage of participants|||Number
2827415|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.|||Percentage of participants|||Number
2827416|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.|||Percentage of participants|||Number
2827417|NCT00322465|Secondary|Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.~Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).~Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Percentage of participants|||Number
2827902|NCT00319735|Secondary|Evaluate Toxicity|To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|Grade 3 toxicities occurring in >5% of participants are reported. Safety data is presented in totality in the adverse events section.|||participants|||Number
2827418|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
2827419|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo|||Participants|||Number
2827420|NCT00322452|Secondary|Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.|||Participants|||Number
2827421|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.|||Participants|||Number
2827422|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.|||Participants|||Number
2827423|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases|Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827424|NCT00322452|Secondary|Vomiting|Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827425|NCT00322452|Secondary|Nausea|Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827426|NCT00322452|Secondary|Diarrhoea|Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827903|NCT00319735|Secondary|Time to Relief of Dysphagia|To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab|36 months|No data was collected or analyzed for this secondary objective.||||||
2827427|NCT00322452|Secondary|Rashes/Acnes|Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827428|NCT00322452|Secondary|Neurotoxicity|Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827429|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia|Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827430|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia|Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827431|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia|Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827432|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia|Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|||Participants|||Number
2827433|NCT00322452|Secondary|Objective Tumour Response Rate According to RECIST|Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.|||Participants|||Number
2827434|NCT00322452|Secondary|Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)|Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.|Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.|Analysis was carried out on Intention-to-treat (ITT) population.|||Months||95% Confidence Interval|Median
2827435|NCT00322452|Primary|Median Progression Free Survival (PFS) in Months|PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.|||Months||95% Confidence Interval|Median
2827436|NCT00322439|Secondary|Percentage of Body Surface Area Affected by Psoriasis|Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of body surface area||Standard Error|Mean
2827437|NCT00322439|Secondary|Work Productivity and Activity Impairment (WPAI)|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores).|||units on a scale||Standard Error|Mean
2827438|NCT00322439|Secondary|Healthcare Resource Use|"This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:~How many times have you been to any physician's office or urgent care clinic, not including your dermatologist?~How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?~How many times have you received care from a health professional (HP) in your home?~How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?~How many times have you had a friend or family member take time off work to provide care or transportation?"|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||times||Standard Error|Mean
2827439|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||units on a scale||Standard Error|Mean
2827440|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Total Score|EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||units on a scale||Standard Error|Mean
2827441|NCT00322439|Secondary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of participants|||Number
2827442|NCT00322439|Secondary|Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1|The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of participants|||Number
2827443|NCT00322439|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).|||percentage of participants|||Number
2827444|NCT00322439|Secondary|Five-year Cumulative Incidence for Events of Medical Interest (EMIs)|Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.|5 years|Full analysis set|||proportion of participants||95% Confidence Interval|Number
2827505|NCT00322049|Primary|Reactogenicity in Terms of Solicited Symptoms After Dose 1 of the Dengue Vaccine vs. Control Vaccine.|Local and general solicited reactogenicity using diary cards for 21 days (days 0-20) after the first dose of dengue/control vaccine|21-day follow-up period after Dose 1|Format of results is consistent with how data was presented in the Final Clinical Study Report. Combining of cohorts B and C was due to both cohorts being full dose|||specified events|||Number
2827445|NCT00322439|Primary|Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events|A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).|5 years||||proportion of participants||95% Confidence Interval|Number
2827446|NCT00322387|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population. Six participants with MM had 2 transplants.|||transplants|Participants||Number
2827447|NCT00322387|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.|||ratio||Standard Deviation|Mean
2827448|NCT00322387|Primary|Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant|Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|13 months|Safety population who received at least one dose of plerixafor.|||participants|||Number
2827449|NCT00322374|Secondary|Number Of Participants With Tumor Response by Duration of Response Category|Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.|||participants|||Number
2827450|NCT00322374|Secondary|Duration of Tumor Response|Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.|||months||Full Range|Median
2827451|NCT00322374|Secondary|Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease|Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria.|From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.|||participants|||Number
2827452|NCT00322374|Secondary|Epirubicin Vss|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||liters||Standard Deviation|Mean
2827453|NCT00322374|Secondary|Epirubicin CLT|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||L/h||Standard Deviation|Mean
2827454|NCT00322374|Secondary|Epirubicin T-Half|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||hours||Standard Deviation|Mean
2827543|NCT00321906|Secondary|Severity of Acute Rejection at 12 Months|"Raw proportion of patients that experienced rejection at or above grade A2 by 12 months.~Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos||||percentage of participants|||Number
2827455|NCT00322374|Secondary|Epirubicin AUC(INF)|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng·h/mL||Standard Deviation|Mean
2827456|NCT00322374|Secondary|Epirubicin Cmax|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng/ml||Standard Deviation|Mean
2827457|NCT00322374|Secondary|Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||liters||Standard Deviation|Mean
2827458|NCT00322374|Secondary|Clearance (CLT) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||L/h||Standard Deviation|Mean
2827459|NCT00322374|Secondary|Terminal Half-life (T-Half) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||hours||Standard Deviation|Mean
2827460|NCT00322374|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng·h/mL||Standard Deviation|Mean
2827461|NCT00322374|Secondary|Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone|Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.|||ng/ml||Standard Deviation|Mean
2827462|NCT00322374|Secondary|Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.|All participants who received at least 1 cycle of therapy were evaluable for safety; adverse events and other symptoms were graded according to CTCAE Version 3.0.|||participants|||Number
2827463|NCT00322374|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.|Day 21 of Cycle 1|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and were observed for ≥21 days following the first dose or the participant experienced DLT.|||mg^m2|||Number
2827464|NCT00322374|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks|From Baseline to the end of Cycle 1 (Day 21)|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and was observed for ≥21 days following the first dose or the participant experienced DLT.|||Participants|||Number
2829323|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 48|Subjects with elevated ALT at baseline that return to normal by Week 48.|48 Weeks|RAT Analysis Set - subjects with ALT above ULN at baseline. Non-Completers=Failure|||percentage of participants|||Number
2827465|NCT00322348|Secondary|Area Under the Plasma Concentration Curve (0-12 Weeks)|Area under the plasma concentration curve (0-12 weeks) derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set|||ng/mL||Full Range|Geometric Mean
2827466|NCT00322348|Secondary|Time to Maximum Plasma Concentration, Tmax (Hours)|Time to maximum plasma concentration, Tmax (hours), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set|||hours||Full Range|Geometric Mean
2827467|NCT00322348|Secondary|Maximum Plasma Concentration, Cmax (ng/mL)|Maximum plasma concentration, Cmax (ng/mL), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the pharmacokinetic (PK) subgroup|||ng/mL||Full Range|Geometric Mean
2827468|NCT00322348|Secondary|Oestradiol (E2) Serum Concentrations at Week 24|A comparison of mean E2 serum concentrations at timepoint(s) post Day 1 performed using analysis of covariance (ANCOVA), with treatment group, baseline E2 serum concentrations and country as covariates. Data analysed on the log scale; log scale mean and pooled log scale standard deviation from Analysis of Covariance (ANCOVA) presented.|Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presented||||pmol/L||Standard Deviation|Log Mean
2827469|NCT00322348|Secondary|Objective Response Rate (ORR) at Week 24|Number of participants who were objective responders at Week 24 over the number of participants evaluable for response x 100. An objective responder = a participants whose best unconfirmed response is either CR (Complete Response Disappearance of all target lesions) or PR (Partial Response At least a 30% decrease in target lesions)|Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.||||Percentage of participants|||Number
2827470|NCT00322348|Primary|Percentage of Participants With Progression Free Survival (PFS) at Week 24|The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.|Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).||||Percentage of participants|||Number
2827471|NCT00322335|Primary|Number of Subjects With Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)|Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up.|||subjects|||Number
2827472|NCT00322335|Primary|Anti-PSC Concentrations|Concentrations for anti-PSC antibody were expressed as GMCs.|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
2827473|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2827474|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2827475|NCT00322335|Primary|Anti-PRP Concentrations|Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
2827476|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2829324|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 48|ULN for males = 43 U/L; 34 U/L for females|48 Weeks|RAT Analysis Set Non-Completers=Failure|||percentage of participants|||Number
2827477|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2827478|NCT00322335|Primary|rSBA-MenC Titers|"Titers are expressed as Geometric Mean Titers (GMTs).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||titer||95% Confidence Interval|Geometric Mean
2827479|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128|"The cut-off value for the rSBA-MenC titers was equal to or above 1:128.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2827480|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32|"The cut-off value for the rSBA-MenC titers was equal to or above 1:32.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2827481|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8|"The cut-off value for the rSBA-MenC titers was equal to or above 1:8.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).|||subjects|||Number
2827482|NCT00322309|Secondary|Percent Urines Positive for Riboflavin|This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.|Weeks 1-11||||Percentage of total urines examined||Standard Deviation|Mean
2827483|NCT00322309|Secondary|Pill Count|Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.|Weeks 1 to 11||||Percentage of dispensed capsules||Standard Deviation|Mean
2827484|NCT00322309|Secondary|Hamilton Depression Rating Scale|Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.|Week 11||||Scores on a scale||Standard Deviation|Mean
2827485|NCT00322309|Secondary|The Clinical Global Impression Observer (CGI-O)Comparison for Week 11|Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.|Week 11|Data was analyzed fof all subjects for whom data from the second evaluation visit was available|||Scores on a scale||Standard Deviation|Mean
2827486|NCT00322309|Primary|Ln Benzoylecgonine Concentration||Week 11|Data was analyzed for all subjects who provided data for the second assessment visit.|||ln (ng/ml)||Standard Deviation|Mean
2827487|NCT00322231|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|Per-protocol population|||Geometric mean fold rise||95% Confidence Interval|Number
2827488|NCT00322231|Secondary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination|4 weeks postvaccination|Per-protocol population|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2827489|NCT00322231|Primary|Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event|To Day 28 postvaccination|All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.|||Participants|||Number
2827504|NCT00322049|Primary|Geometric Mean Titers (GMT) for N Antibody to All Four Serotypes and Japanese Encephalitis (JE) Vaccine|Assess the immunogenicity of the dengue vaccine in terms of GMTs 30 days post-Dose 2 of dengue vaccine for all four serotypes (DEN-1, 2, 3, 4 and JE (Japanese encephalitis)). Analysis of immunogenicity was performed on the ATP cohort.|30 days post Dose 2|GMT calculated on all subjects. Dil = Dilution; P1(M1) = blood sampling on month after dose 1, at study month 1; PII(M7) = blood sampling one month after dose 2, at study month 7; PII(M8.5) = blood sampling 2 1/2 months after dose 2, at study month 8.5. Combining of cohorts B and C was due to both cohorts being full dose|||titers||95% Confidence Interval|Mean
2829325|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48||48 Weeks|RAT Analysis Set Non-Completers=Failure|||percentage of participants|||Number
2827490|NCT00322153|Secondary|Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)|The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).|Baseline to week 24|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
2827491|NCT00322153|Primary|Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)|"The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating marked improvement to a score of 4, indicating no change to a score of 7, indicating marked worsening."|Week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Mean
2827492|NCT00322153|Primary|Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)|The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.|Baseline to week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.|||Units on a scale||Standard Error|Least Squares Mean
2827493|NCT00322101|Secondary|Incidence and Severity of Acute and Chronic Graft-vs-host Disease||After transplantation||||participants|||Number
2827494|NCT00322101|Secondary|Incidence of Disease Progression/Relapse|Disease progression/relapse was defined by IWG criteria|After stem cell infusion to date of last follow up.||||participants|||Number
2827495|NCT00322101|Secondary|Donor Cell Engraftment|Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.|After stem cell infusion to day 28|2 patients who were randomized to receive nonmyeloablative conditioning did not undergo transplant due to relapse and withdrawal of consent|||participants|||Number
2827496|NCT00322101|Secondary|Non-relapse Mortality||At 100 days|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent|||participants|||Number
2827497|NCT00322101|Secondary|Progression-free Survival|IWG criteria was used to determine disease progression|After stem cell infusion to date of last follow up.|2 patients in the nonmyeloablative arm did not receive a transplant due to relapse and withdrawal of consent|||participants|||Number
2827498|NCT00322101|Primary|Overall Survival||At 2 years|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent|||participants|||Number
2827499|NCT00322049|Secondary|Percentage of Subjects With a Dengue Viremia 10 Days Post Booster Dose|"Percentage of subjects with a dengue viremia 10 days after each dose of vaccine.~RT PCR = Reverse-transcriptase polymerase chain reaction Nested PCR - Nested polymerase chain reaction~Per protocol, all participants receiving a Dengue Vaccine were combined for Dengue Viremia assessment via RT-PCR and Nested PCR"|10 days after post dose 1 and 2|All participants with evaluable results are reported via RT-PCR and Nested PCR analysis. Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia by RT-/nested PCR, for seven subjects (2 in cohort B and 5 in cohort C).|||% of subjects|||Number
2827500|NCT00322049|Secondary|Incidence of Dengue Specific Symptoms|Percentage of subjects showing incidence of dengue specific symptoms during the 30-day follow-up period after vaccinations|30-day follow-up period after dose 1 and 2||||% of subjects with specified symptoms||95% Confidence Interval|Mean
2827501|NCT00322049|Primary|JE Vaccine Response|Seropositivity rates and GMTs for N lg to JEV antibodies. Pre= Pre vaccination, blood sampling prior to the first vaccine dose; PI(M1)= Post 1, month 1, blood sampling one month after dose 1 at study month 1; PI(M6)= Post 1, month 6, blood sampling 6 months after dose 1 at study month 6; PII(M7)= Post II, month 7, blood sampling one month after dose 2 at study month 7; PIV(M8.5)= Post IV, month 8.5, blood sampling after 2 doses of dengue/control and 2 doses of JE vaccines at study month 8.5|Pre-vaccination, 1, 6, 7 and 8.5 months after two doses of dengue vaccine|Combining of cohorts B and C was due to both cohorts being full dose|||% of subjects with titer within range||95% Confidence Interval|Mean
2827502|NCT00322049|Primary|Percent of Participants With Seronegative Neutralizing (N) Antibody Titers to Each DEN Serotype After Dengue Dose 2 (and 2 Doses of JE|"Seropositivity for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2 (and 2 doses of JE).~Seronegative (antibody titer <10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination."|month 8.5||||% of responders||95% Confidence Interval|Mean
2827503|NCT00322049|Primary|Percent of Participants With Seronegative Neutralizing (N) Antibody Titers to Each DEN Serotype After Dose 2|"Seronegative for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2.~Seronegative (antibody titer <10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination."|month 7 after dose 2||||% of responders||95% Confidence Interval|Mean
2829326|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48||48 Weeks|RAT Analysis Set|||U/mL||Standard Deviation|Mean
2827506|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Standard Deviation|Mean
2827507|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Inter-Quartile Range|Median
2827508|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.|||percentage of days||Standard Deviation|Mean
2827509|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.|||percentage of days||Inter-Quartile Range|Median
2827510|NCT00321971|Primary|Depressive Symptoms|Depressive symptoms were measured with Center for Epidemiological Studies - Depression Scale (CES-D). The CES-D was designed as a self-report measure of depressive symptoms in nonpsychiatric subjects and has been used with spousal dementia caregiving populations with no report of negative psychological effects. It is composed of 20 items, each rated on a 4-point response scale corresponding to the frequency of the symptom in the preceding week. The possible range of CES-D scores is 0-60, with a higher score indicating more severe symptoms. A cutoff score of 16 or greater is indicative of individuals at high risk for clinical depression. The CES-D was chosen because of its relatively high internal reliability (Cronbach's alpha = .88) and predictive validity for the diagnosis of depression.|Baseline and 1-, 3-, 6-, and 12- months post-treatment|Using an intention-to-treat approach, we performed a repeated-measures linear mixed effects analysis for each study outcome. This analysis included group assignment (PST-MCI/AD Caregiving vs NT), type of caregiver (MCI versus dementia), and time (baseline, 1-, 3-, 6-, and 12-month follow-up). The depression data were log-transformed for analysis.|||units on a scale||Standard Deviation|Mean
2827511|NCT00321932|Secondary|Mean Change in Total Testosterone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning.|From Time of Transplant to 12 Months Post-Transplant||||ng/dL||Standard Deviation|Mean
2827512|NCT00321932|Secondary|Mean Change in Ultrasensitive Estradiol|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics.|From Time of Transplant to 12 Months Post-Transplant||||pg/ml||Standard Deviation|Mean
2827513|NCT00321932|Secondary|Mean Change in Thyroid Function Test 4|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem.|From Time of Transplant to 12 Months Post-Transplant||||ng/dL||Standard Deviation|Mean
2827514|NCT00321932|Secondary|Mean Change in Follicle-Stimulating Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant||||IU/L||Standard Deviation|Mean
2827515|NCT00321932|Secondary|Mean Change in Luteinizing Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant||||IU/L||Standard Deviation|Mean
2827516|NCT00321932|Secondary|Mean Change in Urinary N-terminal Telopeptide|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover.|From Time of Transplant to 12 Months Post-Transplant||||nM Bone Collagen Equivalents/mM creatini||Standard Deviation|Mean
2827517|NCT00321932|Secondary|Mean Change in Serum Bone Specific Alkaline Phosphate|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women.|From Time of Transplant to 12 Months Post-Transplant||||U/L||Standard Deviation|Mean
2827518|NCT00321932|Secondary|Mean Change in Serum Osteocalcin|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process.|From Time of Transplant to 12 Months Post-Transplant||||ng/ml||Standard Deviation|Mean
2827776|NCT00320424|Secondary|Number of Transfused Participants|Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
2827519|NCT00321932|Primary|Mean Change in Bone Mineral Density|"Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months.~This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline."|From Time of Transplant to 12 Months Post-Transplant||||percent||Standard Deviation|Mean
2827520|NCT00321919|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche's standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10^9 cells/liter [L]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter [mmol /L]) and potassium (reference range is 3.4-4.8 mmol /L).|Baseline, every 3 months up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment. The ‘’n” represents the number of participants assessed for each laboratory parameter.|||participants|||Number
2827521|NCT00321919|Secondary|Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs|Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.|Up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment.|||participants|||Number
2827522|NCT00321919|Secondary|Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire|The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.|Baseline, Year 1, and Year 2|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||units on a scale||Standard Error|Least Squares Mean
2827523|NCT00321919|Secondary|Mean Values of Body Surface Area|The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.|Baseline, Year 1, Year 2, Year 3, and Year 4.|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for Body surface area through echocardiogram at Baseline, Year 1, Year 2, Year 3 and Year 4.|||Square meter||Standard Deviation|Mean
2827524|NCT00321919|Secondary|Mean Values of Echocardiography Parameters|Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.|Baseline, Year 1, Year 2, Year 3, and Year 4|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for each echocardiography parameter at Baseline, Year 1, Year 2, Year 3 and Year 4.|||centimeters||Standard Deviation|Mean
2827525|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Volume (LV Volume )|Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LV Volume at Baseline, Week 12, Week 24, Week 36 and Week 48.|||milliliters per meter square||Standard Deviation|Mean
2827526|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)|LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVEF and FS at Baseline, Week 12, Week 24, Week 36, and Week 48.|||percentage||Standard Deviation|Mean
2827527|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Mass Index (LVMI)|LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVMI at Baseline, Week 12, Week 24, Week 36, and Week 48.|||gram/square meter||Standard Deviation|Mean
2828364|NCT00315731|Secondary|Duration of Response|Duration of response is defined as the time from first documented response (CR, CRu, or PR) until disease progression.|Week 7 to Week 260 post treatment|ITT-E Population. Only participants who had a response (CR, CRu, or PR) were evaluated.|||months||95% Confidence Interval|Median
2827528|NCT00321919|Secondary|Duration of Hospitalization for Cardiovascular Events|The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. Data for the participants present at the time of assessment was used for analysis.|||days||Standard Deviation|Mean
2827529|NCT00321919|Secondary|Median Time to First Hospitalization Due to Cardiovascular Events|Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
2827530|NCT00321919|Secondary|Total Number of Cardiovascular Intervention|Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||number of cardiovascular intervention|||Number
2827531|NCT00321919|Secondary|Median Time to First Cardiovascular Intervention|Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
2827532|NCT00321919|Secondary|Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)|The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for shifts in NYHA class from baseline.|||participants|||Number
2827533|NCT00321919|Secondary|Number of Participants Who Died Due to All Causes|Number of participants who died due to all causes are presented in table below.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||participants|||Number
2827534|NCT00321919|Secondary|Median Time to Death Due to All Causes|Time to death due to all causes is the time determined between randomization and death due to all causes.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
2827535|NCT00321919|Secondary|Number of Participants Who Died Due to Cardiovascular Events|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||participants|||Number
2827536|NCT00321919|Secondary|Median Time to Death Due to Cardiovascular Events|Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
2827537|NCT00321919|Primary|Median Time to First Cardiovascular Event|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.|||days||Inter-Quartile Range|Median
2827538|NCT00321906|Secondary|Overall Survival at 36 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 36 months.|36 mos||||percentage of participants|||Number
2827539|NCT00321906|Secondary|Overall Survival at 24 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 24 months.|24 mos||||percentage of participants|||Number
2827540|NCT00321906|Secondary|Overall Survival at 12 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 12 months.|12 mos||||percentage of participants|||Number
2827541|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 36 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 36 months.|36 mos||||percentage of participants|||Number
2827542|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 24 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 24 months.|24 mos||||percentage of participants|||Number
2827544|NCT00321906|Secondary|Acute Rejection-free Survival at 12 Months|"Kaplan-Meier estimate of proportion of patients that had not experienced acute rejection by 12 months. Acute rejection is defined as rejection at any of the following grades.~Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos|The analysis population included patients who underwent at least one transbronchial biopsy.|||percentage of participants|||Number
2827545|NCT00321906|Primary|Acute Rejection Rate at 12 Months|Raw proportion of patients that experienced acute rejection at or before 12 months.|12mos||||percentage of participants|||Number
2827546|NCT00321893|Primary|Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months|Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.|||participants|||Number
2827547|NCT00321893|Primary|Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months|For single nodules >5 mm, clinical meaningful shrinkage of 30% or > longest diameter (LD) considered treatment success after 1 year treatment; for <5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target & non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% > sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.|||participants|||Number
2827548|NCT00321893|Primary|Size of CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years|Baseline assessment|Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.|||lung nodules|Participants||Number
2827549|NCT00321893|Primary|Number CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.|Baseline assessment|Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.|||lung nodules|Participants||Number
2827550|NCT00321854|Secondary|Clinically Significant Abnormalities in Vital Signs||Baseline and Month 15|Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.|||percentage of participants|||Number
2827551|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates||Baseline and Month 15|Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.|||percentage of participants|||Number
2827552|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes||Baseline and Month 15|Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX|||percentage of participants|||Number
2827553|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes||Baseline and Month 15|Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX|||percentage of participants|||Number
2827554|NCT00321854|Secondary|Percentage Change From Baseline in the Striatum Uptake at Month 15|The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).|Baseline and Month 15|The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.|||Percentage change||Standard Error|Least Squares Mean
2828406|NCT00315588|Primary|Insulin Independence.|Number of Participants who Achieved Insulin Independence at 1 Year|1 year||||Participants|||Count of Participants
2829327|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 48||48 Weeks|RAT Analysis Set|||log10 copies/mL||Standard Deviation|Mean
2827555|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827556|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827557|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827558|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827559|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827560|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827561|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827562|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827563|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827564|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827565|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827566|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827567|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827568|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827569|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.|||Participants|||Number
2827570|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
2827571|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
2827572|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
2827573|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
2827574|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Inter-Quartile Range|Median
2827575|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.|||Units on a scale||Inter-Quartile Range|Median
2827576|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827577|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827578|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827579|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.|||Units on a scale||Standard Error|Least Squares Mean
2827580|NCT00321854|Secondary|Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15|The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.|||Participants|||Number
2827581|NCT00321854|Secondary|Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.|||Participants|||Number
2827582|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827583|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827584|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827585|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827586|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
2827587|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827588|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827589|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827590|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827591|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
2827592|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827593|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827594|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827595|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827596|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
2827597|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827598|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827599|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827600|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827601|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
2827602|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827603|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827604|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827605|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.|||Units on a scale||Standard Error|Least Squares Mean
2827606|NCT00321854|Primary|Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial|||Units on a scale||Standard Error|Least Squares Mean
2827607|NCT00321828|Secondary|Overall Survival as Measured by Death From Any Cause||Time from start of study through year 5|||||||
2827608|NCT00321828|Secondary|Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0||Time from start of study through year 5|||||||
2827609|NCT00321828|Secondary|Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery||Time from start of study through year 5|||||||
2827610|NCT00321828|Secondary|Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery||Time from start of study through year 5|||||||
2827611|NCT00321828|Secondary|Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery||Time from start of study through year 5|||||||
2827612|NCT00321828|Secondary|Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration||Time from start of study through year 5|||||||
2827613|NCT00321828|Primary|Major Morbidity Related to the Intact Primary Tumor|Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.|24 months||||probability of major morbidity (%)||95% Confidence Interval|Number
2827614|NCT00321789|Secondary|Number of Participants Prescribed Cholesterol Medication|This was assessed via electronic medical record abstraction. Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).|11-month follow-up||||participants|||Number
2827615|NCT00321789|Secondary|Number of Participants With Goal LDL-C|Assessed via non-fasting blood test. Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).|11-month follow-up||||participants|||Number
2827616|NCT00321789|Secondary|Saturated Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||percentage of calories||Standard Deviation|Mean
2827617|NCT00321789|Secondary|Total Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||percentage of calories||Standard Deviation|Mean
2827618|NCT00321789|Secondary|Duration of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up||||hours per week||Inter-Quartile Range|Median
2827619|NCT00321789|Secondary|Frequency of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up||||times per week||Inter-Quartile Range|Median
2827620|NCT00321789|Secondary|Fiber Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire.|11-month follow-up||||grams per day||Standard Deviation|Mean
2827621|NCT00321789|Secondary|Cholesterol Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||milligrams per day||Standard Deviation|Mean
2827622|NCT00321789|Secondary|Total Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||grams per day||Standard Deviation|Mean
2827623|NCT00321789|Secondary|Saturated Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||grams per day||Standard Deviation|Mean
2827624|NCT00321789|Secondary|Caloric Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up||||kcal/day||Standard Deviation|Mean
2827625|NCT00321789|Primary|Low-density Lipoprotein Cholesterol|assessed with non-fasting blood test|11-month follow-up||||mg/dL||Standard Deviation|Mean
2827626|NCT00321763|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2827627|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2828437|NCT00315328|Primary|Mean Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||ETDRS letter score||Standard Deviation|Mean
2827628|NCT00321763|Primary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2827629|NCT00321763|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
2827630|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .|||subjects|||Number
2827631|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .|||subjects|||Number
2827632|NCT00321763|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
2827633|NCT00321763|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
2827634|NCT00321763|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
2827635|NCT00321763|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
2827636|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
2827637|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
2827638|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.|||Percentage of Subjects|||Number
2828467|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
2827639|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
2827640|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
2827641|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.|||Percentage of Subjects|||Number
2827642|NCT00321711|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks)|Study day 1 through the interim follow-up visit (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2827643|NCT00321711|Secondary|Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2827644|NCT00321711|Secondary|Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2827645|NCT00321711|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants|||Participants|||Number
2827646|NCT00321698|Secondary|Clinical Progression-free Rate as Determined by <0.1ng PSA Results|The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.|3, 6, 9, 12 months and annually, up to 5 years||||percentage of participants||95% Confidence Interval|Number
2827647|NCT00321698|Secondary|Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures|"Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score.~AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe.~EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL."|Baseline and 12 Months Post-Prostatectomy|Scores not available for some participants|||units on a scale||95% Confidence Interval|Mean
2827648|NCT00321698|Secondary|Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:~The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body."|5 weeks|For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.|||Participants|||Count of Participants
2827649|NCT00321698|Secondary|Clinical Response to Treatment as Measured by Urologic Examination||Regular intervals (clinical contact)||2020-12-31|12/2020||||
2827650|NCT00321698|Secondary|Long-term Safety||Regular intervals (clinical contact)||2020-12-31|12/2020||||
2827651|NCT00321698|Secondary|Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA|"All participants were combined for this assessment as pre-specified in the protocol.~The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported.~PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years"|Baseline (pre-treatment) and 1 month after surgery (post-treatment)|Pre- and post-treatment PSA values were available in 22 of 25 patients.|||percentage change||95% Confidence Interval|Mean
2827652|NCT00321698|Primary|Pathologic Response Rate at the Phase II Dose|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:~The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b."|4-6 weeks after study treatment||||participants|||Number
2827653|NCT00321698|Primary|Maximum Tolerated Dose (MTD)|"Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel.~The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling).~MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped."|5 weeks||||mg/m^2|||Number
2827654|NCT00321685|Secondary|5-year Recurrence-free Survival Rate|Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.|recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients who underwent surgery after neoadjuvant therapy|||percentage of participants||90% Confidence Interval|Number
2827655|NCT00321685|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method.|survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2827656|NCT00321685|Secondary|Resection Rate for T4 Rectal Cancers|Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers|Assessed at surgery time|eligible and treated patients with T4 rectal cancers|||percentage of participants||90% Confidence Interval|Number
2827657|NCT00321685|Secondary|Resection Rate for T3 Rectal Cancers|Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers|Assessed at surgery time|eligible and treated patients with T3 rectal cancers|||percentage of participants||90% Confidence Interval|Number
2827658|NCT00321685|Primary|Pathologic Complete Response Rate|Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients|Assessed at surgery time|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2827659|NCT00321672|Secondary|"Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12"||Weeks 2-12||||Percentage of Participants|||Number
2827660|NCT00321672|Secondary|"Absolute Change in the Mean Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12."||Weeks 2-12.||||Numeric Pain Rating Scale (0 to 10)||Standard Error|Least Squares Mean
2827661|NCT00321672|Primary|"The Primary Measure of Efficacy Was the Percent Change in the Average Pain for the Past 24 Hours Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12."|"Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing average pain for the past 24 hours for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain."|Weeks 2-12|Analyses were intention to treat (ITT). A modified last observation carried forward (LOCF) approach was used to impute missing data. Each NGX-4010 group was compared with its respective control group.|||Percent Change from baseline||Standard Error|Least Squares Mean
2827662|NCT00321646|Secondary|PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.|The rate of PSA decline by 50% compared to baseline PSA.|after 6 months of ajuvant chemotherapy.||||proportion of participants||95% Confidence Interval|Number
2827663|NCT00321646|Primary|Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy|A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.|after 6 months of neoadjuvant chemotherapy.||||proportion of participants||95% Confidence Interval|Number
2827664|NCT00321620|Secondary|Time to the First-And-Subsequent On-Study SRE|"Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.~This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|Up to 40.5 months|Full Analysis Set, composed of all randomized participants|||Events|||Number
2827665|NCT00321620|Secondary|Time to the First On-Study SRE (Superiority)|Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants|||Days||95% Confidence Interval|Median
2827666|NCT00321620|Primary|Time to the First On-Study SRE (Non-inferiority)|Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants|||Days||95% Confidence Interval|Median
2827667|NCT00321594|Primary|Tumor Response in Patients With Inoperable HCC Using Belinostat (Phase II)|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The 95% confidence intervals should be provided.|Every 2 courses (approximately 6 weeks)||||Participants|||Count of Participants
2827668|NCT00321594|Primary|Dose-limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) of Belinostat in Patients With Inoperable HCC (Phase I)|DLT is defined as any grade 4 hematological toxicity and any grade 3 or 4 non hematological toxicity during cycle 1, excluding alopecia. Specifically, grade 3 nausea, vomiting, or diarrhea that does not respond to therapy is considered dose-limiting. Also, delays in treatment greater than 2 weeks are also dose-limiting. MTD is defined as the dose below which >= 2 of 3 or >= 2 of 6 patients experience DLT. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Course 1||||Participants|||Count of Participants
2827669|NCT00321555|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 83 months and 15 days.||||Participants|||Count of Participants
2827670|NCT00321555|Secondary|Duration of Response|Duration of response is the duration that the patients qualifies for at least a Partial Response (PR). Partial response requires all of the following for a period of at least 4 weeks: ≥50% decrease in hairy cell count from pretreatment baseline value by flow cytometry. ≥50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam. No growth in lymphadenopathy. Neutrophils ≥1,500/µL or 50% improvement over baseline without growth factors for at least 4 weeks. Platelets ≥100,000/µL or 50% improvement over baseline. Hemoglobin ≥11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks.|Participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months||||months||95% Confidence Interval|Median
2827671|NCT00321555|Primary|Number of Patients Who Obtain Partial Response/Complete Remission|Partial response requires all of the following for a period of at least 4 weeks: ≥50% decrease in hairy cell count from pretreatment baseline value by flow cytometry. ≥50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam. No growth in lymphadenopathy. Neutrophils ≥1,500/µL or 50% improvement over baseline without growth factors for at least 4 weeks. Platelets ≥100,000/µL or 50% improvement over baseline. Complete remission requires all of the following: no evidence of leukemic cells by routine hematoxylin and eosin stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy (not >2 cm in short axis) by physical examination and appropriate radiographic techniques. Normal complete blood count as exhibited by Neutrophils ≥1,500/µL, Platelets ≥100,000/µL, and Hemoglobin ≥11.0g/dL without transfusions or growth factors for at least 4 weeks.|6 months||||Participants|||Count of Participants
2827672|NCT00321464|Secondary|Time to First and Subsequent On-Study Skeletal-Related Event|Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events.|Up to 34 months|Full Analysis Set, composed of all randomized participants|||Events|||Number
2827673|NCT00321464|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.|||Participants|||Number
2827674|NCT00321464|Primary|Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)|Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.|||Participants|||Number
2827675|NCT00321373|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Day 0 to Day 180)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
2827676|NCT00321373|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
2827677|NCT00321373|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) follow up period after vaccination|The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed.|||Subjects|||Number
2827815|NCT00320385|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.|Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population||||||
2827678|NCT00321373|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed.|||Subjects|||Number
2827679|NCT00321373|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Day 180 post-vaccination.|The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.|||titer||95% Confidence Interval|Geometric Mean
2827680|NCT00321373|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 21 post-vaccination|The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.|||titer||95% Confidence Interval|Geometric Mean
2827681|NCT00321321|Primary|Insulin Secretion|area under the curve AUC and insulin secretion rate|0 - 90 minutes||||pmol/l * 90 minutes|||Number
2827682|NCT00321269|Secondary|Health-Related Quality of Life|Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.|Measured at week 1, week 8|Older Veterans with Congestive Heart Failure|||units on a scale||Standard Deviation|Mean
2827683|NCT00321269|Primary|Beck Depression Inventory II|Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.|Depression and psychological health will be assessed at week 1, week 8|Older Veterans with Heart Failure|||units on a scale||Standard Deviation|Mean
2827684|NCT00321048|Primary|Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score|Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.|6 months post-radiation||||Mean Perfusion Score||Standard Deviation|Mean
2827685|NCT00320801|Primary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).|Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)|The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study.|||Participants|||Number
2827686|NCT00320788|Post-Hoc|Mean Change in BCVA as Measured by ETDRS From Baseline at Week 16|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at Week 16|FAS used for analysis, LOCF|||letters read||Standard Deviation|Mean
2827687|NCT00320788|Post-Hoc|Mean Change of CR/LT From Baseline at Week 16|CR/LT measured in micrometers (µm); lower individual values represent better outcomes|Baseline and at Week 16|FAS used for analysis, LOCF|||µm||Standard Deviation|Mean
2827688|NCT00320788|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|At Week 12|FAS used for analysis, LOCF|||percentage of participants|||Number
2827689|NCT00320788|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at week 12|FAS used for analysis, LOCF|||letters read||Standard Deviation|Mean
2827690|NCT00320788|Secondary|Mean Percent Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome|Baseline and at Week 12|FAS used for analysis, LOCF|||percent change||Standard Deviation|Mean
2827691|NCT00320788|Primary|Mean Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); lower individual values represent better outcomes.|Baseline and at Week 12|Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF)|||μm||Standard Deviation|Mean
2827692|NCT00320749|Secondary|Therapeutic Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks, up to 24 weeks|3 patients were non-evaluable for response or progression free survival as they withdrew consent after cycle 1 of therapy.|||percent of patients|||Number
2827693|NCT00320749|Secondary|Common Toxicities|The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.|Weekly up to 24 weeks|grade 3 and grade 4 toxicities according to National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0|||percent of patients|||Number
2827694|NCT00320749|Primary|Maximum Tolerated Dose (MTD)|MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).|Weekly up to 24 weeks||||mg/m^2|||Number
2828468|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
2827695|NCT00320710|Secondary|Skeletal Morbidity Rate|"An SMR for a patient was defined as the number of occurrences of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the time at risk in years. The number of occurrences and the time at risk were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as at risk. For example, if a patient had 1 SRE during the study, the time at risk was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as time at risk. This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE)."|52 weeks|This population included all participants who were in the zoledronic acid q 4 weeks and zoledronic acid q 12 weeks treatment groups.|||Number of events per year||Standard Deviation|Mean
2827696|NCT00320710|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase|Serum samples were collected to obtain bone specific alkaline phosphatase values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.|||mcg/L||Standard Deviation|Mean
2827697|NCT00320710|Secondary|Change From Baseline in Urinary N-telopeptide / Creatinine Ratio|Urine samples were collected to obtain n-telopeptide and creatinine values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.|||ratio||Standard Deviation|Mean
2827698|NCT00320710|Secondary|Change From Baseline in Mean Analgesic Score|The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.|||score||Standard Deviation|Mean
2827699|NCT00320710|Secondary|Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score|Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.|||scores on a scale||Standard Deviation|Mean
2827700|NCT00320710|Secondary|Time to First Individual Type of SRE|Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.|||Weeks||95% Confidence Interval|Median
2827701|NCT00320710|Secondary|Time to First SRE|An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.|||Days||95% Confidence Interval|Median
2827702|NCT00320710|Primary|Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)|An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.|||Percentage of participants|||Number
2827703|NCT00320671|Primary|Percentage of Participants That Responded to Treatment|Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28|this outcome was assessed throughout the study.|BPRS-A and CGI scores for each group were analysed to determine the percentage of participants that responded to apriprazole and risperidone. The threshold for significance was p=.05|||percentage of response||95% Confidence Interval|Number
2827704|NCT00320606|Secondary|Percent Change From Baseline in Diastolic Blood Pressure|Diastolic blood pressure (BP) measures the pressure in the arteries when the heart is a rest and is thus filled with blood. This outcome assesses the percent change from baseline (diastolic blood pressure measurement at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-to-treat with diastolic blood pressure data available at visit|||Percent change||Inter-Quartile Range|Median
2827843|NCT00320281|Primary|Numerical Rating Scale-NRS|"The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the worst possible pain they have experienced and 0 being no pain."|6 weeks post-injection||||units on a scale||95% Confidence Interval|Mean
2827705|NCT00320606|Secondary|Percent Change From Baseline in Systolic Blood Pressure|Systolic blood pressure (BP) measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. This outcome assesses the percent change from baseline (systolic blood pressure measurement at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-to-treat with systolic blood pressure data available at visit|||Percent change||Inter-Quartile Range|Median
2827706|NCT00320606|Secondary|Percent Change From Baseline in Blood Glucose|Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. The outcome looks at the percent change from baseline (glucose level at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat with glucose data available at visit|||Percent change||Inter-Quartile Range|Median
2827707|NCT00320606|Secondary|Percent Change From Baseline in Total Cholesterol|Percent change from baseline in total serum cholesterol. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. This outcome looks at the percent change from baseline (cholesterol level at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat with cholesterol data available at visit|||Percent change||Inter-Quartile Range|Median
2827708|NCT00320606|Secondary|Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR)|Percent change from baseline at each annual visit. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in the equation, defined as the creatinine value at the start of IS tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS tapering. Serum creatinine measurements and height measurements at the annual visits were used to calculate the annual GFR. When height value was not available, the height collected prior to the annual visit was used in the GFR calculation. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat with GFR data at visits available for analysis|||Percent change||Inter-Quartile Range|Median
2827709|NCT00320606|Secondary|Number of Participants Experiencing Adverse Events by Severity|The results provide the total number of participants experiencing adverse events (AEs). Participants experiencing AEs are stratified into five severity categories: mild, moderate, severe, life-threatening, and death, based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.|Enrollment through end of study (up to 9.5 years)|Intent-To-Treat|||Participants|||Count of Participants
2827710|NCT00320606|Secondary|Distribution of Histologic Severity Among Rejection Episodes|The number of participants within each level of histologic severity based on BANFF grading criteria (Mild, Moderate, Severe).|Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years)|Participants from the Intent-to-treat group who experienced a biopsy-proven rejection episode|||Biopsy Proven rejection episodes|||Number
2827711|NCT00320606|Secondary|Immunosuppression-Free Duration|The number of months between the end of immunosuppression withdrawal and either the end of trial participation or the time of restarting immunosuppression|Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression|Intent-to-Treat participants who completed withdrawal|||Months||95% Confidence Interval|Mean
2827712|NCT00320606|Secondary|Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection|The number of days between the start of immunosuppression (IS) withdrawal and the first episode of acute rejection (either clinical rejection or based on BANFF criteria), second episode of rejection that did not require treatment, or the first diagnosis of chronic rejection.|From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years)|Intent-to-Treat participants who experienced acute rejection or were diagnosed with chronic rejection.|||Days||95% Confidence Interval|Mean
2827713|NCT00320606|Secondary|Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal|Participants who died while on the study for any reason as well as participants that experienced the loss of their transplant while a participant in the study.|Enrollment through end of study (up to 9.5 years)|Intent-to-Treat|||Participants|||Count of Participants
2827714|NCT00320606|Primary|Proportion of Participants Successfully Withdrawn From Immunosuppression|Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function.|1 year after completion of immunosuppression withdrawal|Intent-to-Treat|||Proportion of participants|||Number
2827715|NCT00320593|Secondary|Excellent Spectacle Compliance|Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.|Baseline to 3 years|The analysis followed the intent-to-treat principle. Two patients had no compliance data because they had no follow-up visits (one single vision lenses, and one progressive-addition lenses).|||percent of participants|||Number
2827716|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 2 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 2 years|The analysis followed the intent-to-treat principle|||diopters||Standard Deviation|Mean
2827717|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 1 year, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 1 year|The analysis followed the intent-to-treat principle.|||diopters||Standard Deviation|Mean
2827718|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.|||diopters||Standard Deviation|Mean
2827719|NCT00320593|Secondary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.|||participants|||Number
2827720|NCT00320593|Primary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|3 years|All analyses followed the intent-to-treat principle. The Monte Carlo Markov Chain (MCMC) method of multiple imputation was used to impute data for subjects who did not complete the 3-year visit.|||diopters||Standard Deviation|Mean
2827721|NCT00320593|Secondary|Mean Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.|||diopters||Standard Deviation|Mean
2827722|NCT00320593|Primary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.|||participants|||Number
2827723|NCT00320593|Secondary|Distribution of Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.|||participants|||Number
2827724|NCT00320541|Secondary|Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy|The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2827725|NCT00320541|Secondary|Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy|The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2827726|NCT00320541|Secondary|Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy|The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2828469|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 Weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
2827727|NCT00320541|Secondary|Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy|The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2827728|NCT00320541|Secondary|Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy|The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2827729|NCT00320541|Secondary|Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy|The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2827730|NCT00320541|Secondary|Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment|||units on a scale||Standard Deviation|Mean
2827731|NCT00320541|Secondary|Overall Survival|Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.|baseline to death from any cause (up to 35 months)|Intent-To-Treat (ITT) population=all randomized participants, eligible & ineligible. Number of participants with events: PB=35; PB+G=34. Censored participants: PB=59;PB+G=59.|||months||Full Range|Median
2827732|NCT00320541|Secondary|Progression-free Survival (PFS)|PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.|baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)|ITT population=all randomized participants, eligible & ineligible. Participants with events: PB=74; PB+G=72. Censored participants: PB=20 PB+G=21.|||months||Full Range|Median
2827733|NCT00320541|Primary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).|baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)|Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.|||proportion of responders||95% Confidence Interval|Mean
2827734|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
2827735|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)|The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).|Baseline, 12 Weeks|Number of child patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2827774|NCT00320424|Secondary|Rate of Symptomatic DVT|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Safety population used.|||% of normalized events per participant|||Number
2827736|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)|Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).|Baseline, 12 Weeks|Number of adolescent patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2827737|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale|Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
2827738|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
2827739|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
2827740|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains|Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||T-Score||95% Confidence Interval|Mean
2827741|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
2827742|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||units on a scale||95% Confidence Interval|Mean
2827743|NCT00320528|Primary|Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain|Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.|||T-Score||95% Confidence Interval|Mean
2827744|NCT00320515|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measurable disease at baseline. Thirty-five participants were censored.|||months||95% Confidence Interval|Median
2827745|NCT00320515|Secondary|Progression Free Survival|The period from study entry until disease progression or death on study, whichever occurred first.|baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measureable disease at baseline. Twenty-six participants were censored.|||months||95% Confidence Interval|Median
2827746|NCT00320515|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug, had measureable disease at baseline, and had confirmed complete or partial responses. There were 16 patients qualified for the analysis of duration of response. Twelve participants were censored.|||months||95% Confidence Interval|Median
2827747|NCT00320515|Primary|Objective Best Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug. One participant was excluded from analysis because of no measurable disease at baseline.|||participants|||Number
2827748|NCT00320489|Secondary|Participants Discontinuing Because of an Adverse Event (AE) or Death||Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827749|NCT00320489|Secondary|Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin|Treatment-emergent (TE) high ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to >=3 times the ULN at endpoint. TE high AST is defined as a baseline value of <5 times the ULN to >=5 times the ULN at endpoint. TE high total bilirubin is defined as a baseline value of <2 times the ULN to >=2 times the ULN at endpoint. Hy's Rule is defined as ALT >=3 times the ULN and total bilirubin >=2 times the ULN.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827750|NCT00320489|Secondary|Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks|The prolactin reference Range is: Female: 2.0 - 29.0 nanograms per milliliter (ng/mL); Male: 2.0 - 20.0 ng/mL. A treatment-emergent abnormally high value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827751|NCT00320489|Secondary|Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides|Normal to high fasting glucose = <100 milligrams per deciliter (mg/dL) baseline; >=126 mg/dL any time post baseline (or endpoint). Normal to high fasting total cholesterol =<200 mg/dL baseline; >=240 mg/dL any time post baseline or endpoint. Fasting triglycerides <150 mg/dL baseline; >=200 mg/dL and <500 mg/dL any time post baseline or endpoint.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827752|NCT00320489|Secondary|Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks|PCS weight gain is defined as a >=7% increase in weight from baseline at 104 weeks.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827753|NCT00320489|Secondary|Change From Baseline in Weight at 104 Weeks||Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Kilograms||Standard Deviation|Mean
2827754|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization|Number of outpatient surgeries during the study, post-baseline through 104 weeks.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Surgeries||Standard Deviation|Mean
2827755|NCT00320489|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks|BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. For this study, the BPRS total score was derived from 18 PANSS questions. To calculate the score, the score of the 18 questions was added then 18 was subtracted from the total. As an example, if a subject had a score=1 (absent) on all 18 items, the resulting total=zero. Responses range from 0 (absent) to 6 (extremely severe); the Total Score range is 0-108.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a scale||Standard Error|Least Squares Mean
2827756|NCT00320489|Secondary|Number of Participants Experiencing Relapse|Relapse is defined as any one of the following: 1) hospitalization for symptoms related to schizophrenia; 2) an increase of 25% from baseline in the total score on the PANSS (if the baseline score was >40), or an increase of 10 points (if baseline score was <=40) and >=1-point increase from baseline score on the CGI-S score, provided that the increase results in a CGI-S score >=4; 3) deliberate self-injury or injury to others that is deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827757|NCT00320489|Secondary|Median Time to Relapse|Relapse is defined as any 1 of the following: 1) hospitalization for symptoms related to schizophrenia; 2) increase of 25% from baseline in PANSS total score (range:30-210) (if baseline score was >40) or increase of 10 points (if baseline score was ≤40), and ≥1-point increase from baseline on CGI-S score (range:1-7), provided that increase results in CGI-S ≥4; 3) deliberate self-injury or injury to others deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis. On PANSS and CGI-S higher scores indicate greater illness.|Baseline to time of relapse (up to 104 weeks)|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Inter-Quartile Range|Median
2827758|NCT00320489|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827759|NCT00320489|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827760|NCT00320489|Secondary|Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)|Number of participants who discontinued study participation for any reason (excluding sponsor decision).|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Participants|||Number
2827761|NCT00320489|Secondary|Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks|Self-rated scale which measures patient's subjective feelings about taking medications. Each of 10 items is rated as true or false. For items 1, 3, 4, 6, 7, 9, and 10, true is scored as 1; false is scored as 0. For items 2, 5, and 8, true is scored as 0; false is scored as 1. Possible total scores range from 0-10. A subject who answers all 10 questions false will have a score of 3; a subject who answers all 10 questions true will have a score of 7. For 7 out of 10 questions, false is represented by 0, the other 3 questions false is represented by a value=1.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827762|NCT00320489|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)|Self-rated scale which measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1-'very dissatisfied' to 5-'very satisfied'), preference comparing current study medication versus previous medications (scored from 1-'much prefer previous medication' to 5-'much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1-'much less side effects' to 5-'much more side effects'). Range of possible scores is 3-15.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827763|NCT00320489|Secondary|Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks|Interviewer-rated 49-item scale used to assess 4 functional domains in patients with schizophrenia : 1) living situation, 2) instrumental activities of daily living, 3) productive activities and role functioning, and 4) social/recreational functioning. Possible responses and scoring vary by item and by domain, with higher scores representing better functioning. Range of possible scores is 1-100. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827764|NCT00320489|Secondary|Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks|Self-rated scale assessing patients' level of alliance with their therapist, including agreement on goals, tasks, and emotional bond. Each of 12 items is rated from 1 ('never') to 7 ('always'), with higher scores indicating greater alliance. Total Scores range from 12-84. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827765|NCT00320489|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks|Interviewer-rated scale that assesses patients' awareness of and insight into their illness. SUMD can either be based on 4 items or 5 items. Items 1 through 4 are rated from 1 (aware) to 5 (unaware); item 5 assesses correct attribution of symptoms to a mental disorder and is rated from 1 (symptoms correctly attributed) to 5 (symptoms incorrectly attributed). Total Scores for Items (1-4) range from 4 to 20 and Total Scores for Items (1-5) range from 5 to 25. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827766|NCT00320489|Secondary|Number of Hospitalization Days|Mean - calculated based on total number of hospitalization days per patient within reporting interval.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Standard Deviation|Mean
2827767|NCT00320489|Secondary|Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study|Number of days of unpaid care, number of days of workdays missed, number of days of paid care per week during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Standard Deviation|Mean
2827768|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Physician Visits During the Study|Number of outpatient physician visits during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Outpatient physician visits||Standard Deviation|Mean
2827769|NCT00320489|Secondary|Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks|"Self-rated scale completed by patient's caregiver which measures level of burden placed on the caregiver by caring for the patient. Each of 19 items is rated on a scale from 0 (no impact) to 3 (high negative impact). Total Score range is 0-57. If any of the 19 questions were answered not applicable, then a Total Score of 9 was entered. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline."|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827770|NCT00320489|Secondary|Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks|Generic, multidimensional, health-related, quality-of-life instrument. Overall health status is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827771|NCT00320489|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores|SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains. Domains and scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. There are 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827772|NCT00320489|Secondary|Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks|Interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning). Total score range is 0-126. Least Squares Mean (LS Mean) values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data were analyzed on ITT basis. ITT analysis: analysis of all randomized patients allocated to the randomized treatment even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on mixed-model repeated measures (MMRM) methodology.|||Units on a Scale||Standard Error|Least Squares Mean
2827773|NCT00320489|Primary|Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)||Baseline up to 104 weeks|All data was analyzed on an intent-to-treat (ITT) basis. An ITT analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Days||Inter-Quartile Range|Median
2827777|NCT00320424|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
2827778|NCT00320424|Secondary|Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)|Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
2827779|NCT00320424|Secondary|Number of Participants With Major Bleeding During Treatment Period|Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).|From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)|Safety population used.|||Participants|||Count of Participants
2827780|NCT00320424|Secondary|Rate of Distal Only DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed.|||% of normalized events per participant|||Number
2827781|NCT00320424|Secondary|Rate of Proximal DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed.|||% of normalized events per participant|||Number
2827782|NCT00320424|Secondary|Rate of DVT During Treatment Period|Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Efficacy evaluable participants used consisted of a subpopulation of safety population who were judged to be evaluable for all DVT and proximal DVT or distal only DVT by the site of occurrence (total/side of operation/opposite side of operation/both sides). Only those participants with data available at the indicated time points were analyzed.|||% of normalized events per participant|||Number
2827783|NCT00320424|Secondary|Rate of PE During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.|Up to Day 17|Safety population used which consisted of all participants who received at least one dose of study drug.|||% of normalized events per participant||95% Confidence Interval|Number
2827784|NCT00320424|Primary|Rate of Major Bleeding During Treatment Period|Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).|From the first study drug injection up to Day 17|Full analysis set used which consisted of all participants who were assigned to study drug with the exception of those who did not receive study drug at all and those with no valid efficacy data (example no evaluable venogram).|||% of normalized events per participant||95% Confidence Interval|Number
2827785|NCT00320411|Secondary|Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants|Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827786|NCT00320411|Secondary|Mean Survivin H Score for All Participants|Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827787|NCT00320411|Secondary|Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants|Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827788|NCT00320411|Secondary|Mean Heregulin H Score for All Participants|Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827789|NCT00320411|Secondary|Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants|Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827790|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants|Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827791|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants|Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827792|NCT00320411|Secondary|Mean Bcl-2 H Score for All Participants|Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2827793|NCT00320411|Secondary|Mean p-BAD H Score for All Participants|Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation|||units on a scale||Standard Deviation|Mean
2828470|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 Weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
2827794|NCT00320411|Secondary|Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants|Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation.|||units on a scale||Standard Deviation|Mean
2827795|NCT00320411|Secondary|Overall Survival|Overall survival was measured as the time between the start of dosing until death, regardless of cause.|Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.|ITT Population|||weeks||Inter-Quartile Range|Median
2827796|NCT00320411|Secondary|6-month Progression Free Survival|The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.|Baseline to Month 6 (Week 24)|ITT Population|||percentage of participants|||Number
2827797|NCT00320411|Secondary|4-month Progression Free Survival|The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.|Baseline to Month 4 (Week 16)|ITT Population|||percentage of participants|||Number
2827798|NCT00320411|Secondary|Time to Response|Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.|Participants in the ITT Population achieving a partial or complete response|||Days||Full Range|Median
2827799|NCT00320411|Secondary|Clinical Benefit|Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.|ITT Population|||percentage of participants|||Number
2827800|NCT00320411|Secondary|Time to Progression|Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.|Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.|ITT Population|||weeks||Inter-Quartile Range|Median
2827801|NCT00320411|Secondary|Duration of Response|Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.|First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Participants who achieved defined efficacy|||weeks||Inter-Quartile Range|Median
2827802|NCT00320411|Primary|Overall Tumor Response|Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.|Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product|||participants|||Number
2827803|NCT00320398|Secondary|Volume of Transfusion|The total volume of transfusion (RBCs or WB) received by the participant was reported.|Up to Day 17|Safety population.|||mL||Standard Deviation|Mean
2827804|NCT00320398|Secondary|Number of Transfused Participants|The number of participants who received RBCs or WB after the total hip replacement surgery within 48 hours of bleed were reported.|Up to Day 17.|Safety population.|||participants|||Number
2827805|NCT00320398|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.|Safety population.|||participants|||Number
2827806|NCT00320398|Secondary|Percentage of Participants With Pulmonary Embolism During Efficacy Period|The percentage of participants with pulmonary embolism (pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia ) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|Safety population.|||percentage of participants|||Number
2827904|NCT00319735|Secondary|Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy.~Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|Up to 36 months|Participants who underwent esophagectomy|||percentage of participants||95% Confidence Interval|Number
2827807|NCT00320398|Secondary|Percentage of Participants With Symptomatic DVT During Main Efficacy Period|The percentage of participants with different symptoms of DVT (proximal) like pain or tenderness, swelling, warmth, redness or discoloration, and distention of surface veins, post the total hip replacement surgery were reported, where analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|Safety population.|||percentage of participants|||Number
2827808|NCT00320398|Secondary|Percentage of Participants With Distal Only DVT|The percentage of participants with distal only DVT were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|EEP population. Only those participants with data available at the indicated time points were analyzed.|||percentage participants|||Number
2827809|NCT00320398|Secondary|Percentage of Participants With Proximal DVT|The percentage of participants with DVT (proximal) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|EEP population. Only those participants with data available at the indicated time points were analyzed.|||percentage of participants|||Number
2827810|NCT00320398|Secondary|Percentage of Participants With All Deep Vein Thrombosis (DVT)|The percentage of participants with All DVT were reported, where the analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.|Up to Day 17|Efficacy Evaluable Patients (EEP) included subpopulation of safety participants judged to be evaluable for all DVT, proximal DVT or distal only DVT by site of occurrence (total/ side of operation/ opposite side of operation/ both sides). Only those participants with data available at the indicated time points were analyzed.|||percentage of participants|||Number
2827811|NCT00320398|Secondary|Percentage of Participants With Minor Bleeding|Minor bleeding was defined as the clinically overt bleeding not meeting the criteria for major bleeding like: (Fatal bleed; Including retroperitoneal and intracranial bleeding, or bleed in critical organ [eye, adrenal gland, pericardium, spine]; c) Reoperation due to bleeding or hematoma at operative site; d) Bleeding leading to hemoglobin (Hb) fall > = 2 g/dL(1.6 mmol/L) within 48 hour of the bleed; e)Bleeding that required transfusion of RBCs or WB derived from >= 900 mL of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2), and which were considered more than expected in the clinical context. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.|Up to Day 17|Safety population.|||percentage of participants||95% Confidence Interval|Number
2827812|NCT00320398|Primary|Percentage of Participants With Major Bleeding|Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall > = 2 gram per deciliter (g/dL)(1.6 millimole per litre [mmol/L]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from >= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.|Up to Day 17|The safety population consisted of all participants who received at least one dose of randomized study drug.|||percentage of participants||95% Confidence Interval|Number
2827813|NCT00320398|Primary|Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period|The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).|Up to Day 17|The Full Analysis Set (FAS) population consisted of all participants who were randomized to either treatment with the exception of: those who did not receive study drug at all; and those with no valid post-randomization efficacy data (e.g., no evaluable venogram).|||percentage of participants||95% Confidence Interval|Number
2827814|NCT00320385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.|Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)|Safety Population: all randomized participants who received >=1 dose of investigational product. The Safety Population was based on the actual treatment received, if this differed from that to which the participant was randomized. Only participants whose overall item response rate was greater than 80% for the FACT-B total score were considered (n).|||scores on a scale||Standard Deviation|Mean
2827816|NCT00320385|Secondary|Duration of Response (DR)|DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.|Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population||||||
2827817|NCT00320385|Secondary|Time to Response (TTR)|TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.|Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)|ITT Population||||||
2827818|NCT00320385|Secondary|Clinical Benefit Response (CBR)|CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population|||percentage of participants|||Number
2827819|NCT00320385|Secondary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.|||percentage of participants|||Number
2827820|NCT00320385|Secondary|Overall Survival (OS)|OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.|Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.|||weeks||95% Confidence Interval|Median
2827821|NCT00320385|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.|Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)|Intent-to-Treat (ITT) Population: all randomized participants irrespective of whether or not they actually received study treatment. Only participants with progesterone receptor status were considered for evaluation.|||weeks||95% Confidence Interval|Median
2827822|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE|This assessment was completed by the physician at the screening visit. The physician decided which DSM-IV Diagnosis (as shown in outcome measure data table) best characterized the patient's primary diagnosis of MDE.|Screening|D-23 Original + TAU [(n= 330) + (n= 276)]. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
2827823|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's intent of their most recent suicidal gesture or attempt.~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
2827824|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's medical threat to life of their most recent suicidal gesture or attempt.~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
2827825|NCT00320372|Post-Hoc|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Change From Baseline by Visit Month|The Q-LES-Q-SF is a self-report scale to assess the degree of enjoyment and satisfaction experienced by the patient during the past week. There are 2 forms of this instrument: the short form and the long form. The short form employs the 14 general activities included in the long form, as well as 2 global items. Five-point item scores (1 to 5) are aggregated, with higher scores indicative of greater enjoyment or satisfaction in each domain. The scoring of the Q-LESQ-SF involves summing only the first 14 items to yield a raw total score. The last 2 items are not included in the total score but stand alone. The raw total score ranges from 14 (worst score) to 70 (best score). Higher Q-LES-QSF score indicates more enjoyment and satisfaction (Endicott, Nee et al. 1993).|3-Month Through 60-Month (Post Baseline)|ITT Population minus D-21 Subjects: VNS Therapy Population (D-23=330) + (n= 276) TAU population. The total number of patients in each group is lower than ITT due to missing assessment data, for which a large portion is that of D-21 subjects. The Q-LES-Q-SF was not collected in the D-21 Study.|||units on a scale||Standard Deviation|Mean
2827905|NCT00319735|Primary|Complete Pathologic Response (pCR)|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas.~Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|36 months||||percentage of participants|||Number
2827826|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation|"This assessment was completed telephonically by a third party rater (Central Rater Group). The rating was based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones, which allowed a precise rating of severity. The rater decided whether the rating lied on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then checked the appropriate selection on the MADRS Item 10 Suicidal Thoughts (Ideation).~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|1 Week Pre-Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 2 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.|||Percentage of Patients|||Number
2827827|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Suicides/1000 Person Years)|The number of suicides per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Number of Suicides Per 1000 Person Years|||Number
2827828|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Number of Suicides)|The number suicides on the study were collected from the baseline visit.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Number of Suicides|||Number
2827829|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (All-Cause Mortality/1000 Person Years)|All cause mortality is defined as the number of deaths per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Deaths Per 1000 Person Years|||Number
2827830|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Patient Years Exposed)|Treatment exposure time in years for all patients for all treatment groups were calculated in 1000 person year measure.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Exposure Per 1000 Patient Years|||Number
2827831|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Number of Deaths)|The number of deaths on the study were collected from the baseline visit.|3-Month (baseline or implantation) Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population|||Number of Deaths|||Number
2827832|NCT00320372|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline)|Remission is a binary outcome response variable (Yes/No Inremission) defined as MADRS total score < 9 at visit month assessment post-baseline. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen and in general it is accepted that a score between 0-6 is indicative of a normal/symptom-free individual; 7-19 is indicative of a patient with mild depression; 20-34 is indicative of a patient with moderate depression; and >34 is indicative of a patient with severe depression. Total number of patients in each group may be lower than ITT in a case of missing assessment data.|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population|||Percentage of Participants|||Number
2827833|NCT00320372|Secondary|Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)|"Recurrence based on MADRS is defined as first time attained MADRS total score ≥ 20 after achieving remission. Remission is a binary outcome response variable (Yes/No in-remission) defined as MADRS total score </= 9 at visit month assessment post-baseline. Duration of remission Computed as recorded date of the first recurrence/relapse (MADRS score >/= 20) minus the recorded date of first achieved remission (MADRS score </=9). Only a subpopulation that achieved remission will be included in the summary.~Time-to-event analyses were summarized using Kaplan-Meier curves. Patients who did not achieve recurrence at the end of the study were censored on the last visit date recorded. Additionally, patients who discontinued early were censored on last date of contact. Censored observations and confidence intervals for the estimated median times were calculated."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population|||Months|Participants|95% Confidence Interval|Median
2827834|NCT00320372|Primary|Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline)|"Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was considered a Responder (Yes = 1) if achieved ≥ 50% reduction from baseline in MADRS total score at visit month assessment post-baseline. A Non-Responder (No = 0) was any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at visit month assessment post-baseline.~Total number of patients in each group may be lower than ITT in a case of missing assessment data."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population|||Percentage of Participants|||Number
2827835|NCT00320281|Secondary|Rehabilitation Interference Scale (RIS)||2 weeks and 6 weeks post-injection|||||||
2827836|NCT00320281|Secondary|Respiratory Function Measures||2 weeks and 6 weeks post-injection|||||||
2827837|NCT00320281|Secondary|Patient Global Outcome Ratings||2 weeks, 6 weeks, and 6 months post-injection|||||||
2827838|NCT00320281|Secondary|Cervical Range of Motion Measurements||2 weeks and 6 weeks post-injection|||||||
2827839|NCT00320281|Secondary|Beck Depression Inventory||2 weeks and 6 weeks post-injection|||||||
2827840|NCT00320281|Secondary|Modified Leeds Neuropathic Symptoms and Signs Scale||2 weeks, 6 weeks, and 6 months post-injection|||||||
2827841|NCT00320281|Primary|Short-Form McGill Pain Questionnaire||2 weeks, 6 weeks, and 6 months post-injection|||||||
2827842|NCT00320281|Primary|Brief Pain Inventory-SF||2 weeks, 6 weeks, and 6 months post-injection|||||||
2827844|NCT00320255|Primary|Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding|"Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:~A decrease in hemoglobin of 20 g/L or more or~Required transfusion of 2 or more units of packed red blood cells or whole blood, or~Occurred in a critical site~Contributed to death.~CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:~Skin hematoma~Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention~Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract~Any other bleeding type that was considered to have clinical consequences."|From first dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827845|NCT00320255|Secondary|Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2827846|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827847|NCT00320255|Secondary|Number of Participants With Distal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827848|NCT00320255|Secondary|Number of Participants With Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827849|NCT00320255|Secondary|Number of Participants With Nonfatal Pulmonary Embolism|"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug||||Participants||95% Confidence Interval|Number
2827850|NCT00320255|Secondary|Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)|"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827851|NCT00320255|Secondary|Number of Participants With All-Cause Death||First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827852|NCT00320255|Secondary|Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death|"VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827861|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 32|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Particpants|||Number
2828471|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 Weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
2827853|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827854|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 30 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827855|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants||95% Confidence Interval|Number
2827856|NCT00320242|Secondary|Percentage Change in Falls|The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.|1 to 2 months|10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue|||% change in fall frequency||Standard Deviation|Mean
2827857|NCT00320242|Secondary|Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.|Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).|2-3 months|10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue|||falls per week||Standard Deviation|Mean
2827858|NCT00320242|Secondary|Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature|Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period|2-3 months|All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue|||seconds||Standard Deviation|Mean
2827859|NCT00320242|Primary|Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.|The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.|2-3 months|These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.|||change in FOGQ score||Standard Error|Mean
2827860|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 28|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Participants|||Number
2827874|NCT00320112|Primary|Change in Glycemic Control (HbA1c)|The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.|6 months (baseline to 6 months)|Peer Support group: 117 of the 125 provided 6 month data and 113 provided physiologic measures. Nurse Case management participants: 114 of 119 provided 6 month data and 103 provided follow-up physiologic measures.|||percent HbA1c||Standard Deviation|Mean
2827862|NCT00320216|Secondary|Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12|Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score.|Week 12|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Participants|||Number
2827863|NCT00320216|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.|||Participants|||Number
2827864|NCT00320190|Secondary|Median Time to Progression-free Survival|Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression or death (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
2827865|NCT00320190|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression, death, or discontinuation (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
2827866|NCT00320190|Secondary|Percentage of Participants With Complete Cytogenetic Response|Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample.|At 6 and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
2827867|NCT00320190|Secondary|Median Time to MMolR|Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline.|At 3, 6, 9, and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
2827868|NCT00320190|Secondary|Percentage of Participants With On-study AEs of Special Interest|GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.|||Percentage of Participants|||Number
2827869|NCT00320190|Secondary|Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.|||Percentage of participants|||Number
2827870|NCT00320190|Primary|Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR)|MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.|At 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.||||||
2827871|NCT00320112|Secondary|Number of Participants With Insulin Starts at 6 Months|the number of insulin starts at 6 months from baseline.|6 months (baseline to 6 months follow-up)|medical charts were reviewed to obtain this information and all participant charts were reviewed|||participants|||Number
2827872|NCT00320112|Secondary|Change in Diastolic Blood Pressure|change in diastolic blood pressure was measured at 6 months|6 months from baseline|As noted earlier, for physiologic measures only 113 of the 125 peer support participants were able to provide 6 month follow-up data and 103 of 119 nurse management group provided 6 month follow-up data.|||mmHg||Standard Deviation|Mean
2827873|NCT00320112|Secondary|Change in Systolic Blood Pressure Measure|secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months|change in blood pressure at 6 months|comparison of blood pressure measure taken at baseline and then again at 6 months among the two groups. as noted, 113 peer support participants provided physiologic measures at 6 months and 103 of 119 from the nurse management group provided physiologic measures at 6 months.|||mmHg||Standard Deviation|Mean
2827875|NCT00319982|Secondary|Impact of Diltiazem on Systolic Blood Pressure|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits||||mmHg||Standard Error|Mean
2827881|NCT00319982|Primary|Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity|The change in E' velocity (difference between final value - baseline value) was compared between participants who received diltiazem and those who received placebo to gauge treatment response. Please note that the total duration on treatment varied between study subjects to maximize time on treatment for the trial. Specifically, subjects that enrolled earliest had the longest duration of treatment; those who enrolled latest had the shortest duration of treatment with a minimum treatment duration of 1 year. All analyses examine the final study visit on treatment to the baseline visit.|Baseline and final study visits||||cm/sec (difference final-baseline)||Standard Error|Mean
2827882|NCT00319956|Other Pre-specified|Participant Mortality|Data will be collected on the number of participants that did not survive to discharge from the NICU. Data are presented as the percent of participants that did not survive.|Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks||||percentage of mortality|||Number
2827883|NCT00319956|Other Pre-specified|Number of Days on Mechanical Ventilation|Participants will be placed on mechanical ventilation as necessary based on standard of care. Data are presented as the percent of participants in each group receiving mechanical ventilation.|Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks||||days||Standard Deviation|Mean
2827884|NCT00319956|Other Pre-specified|Postnatal Steroid Use|Steroids will be provided as needed based on Standard of Care. Data are presented as the percent of participants that received steroids between birth and discharge from the NICU.|Duration of NICU stay, up to 16 weeks, average stay is about 10 weeks||||percentage of participants|||Number
2827885|NCT00319956|Primary|Incidence of Bronchopulmonary Dysplasia (BPD)|comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.|diagnosis of BPD at 36wks corrected gestational age|Mortality was 18% in the Azithromycin group and 22% in the Placebo group, thus 91 participants in the Azithromycin group and 85 participants in the Placebo group were analyzed.|||percentage w/ BPD|||Number
2827886|NCT00319839|Secondary|Overall Survival and Progression-free Survival in Patients||3 years|||||||
2827887|NCT00319839|Secondary|Frequency and Severity of Toxicities|To assess the frequency and severity of toxicities associated with this treatment.|3 years|Analysis was not completed as the study was terminated early due to low accrual and of the 7 subjects who went on study, only 1 completed treatment.||||||
2827888|NCT00319839|Primary|Overall Response Rate (Complete and Partial Response)|To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.|3 years|Analysis was not completed as the study was terminated early due to low accrual and of the 7 subjects who went on study, only 1 completed treatment.||||||
2827889|NCT00319748|Secondary|Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)|Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 9 patients had recorded values at 6 hours after treatment and were included in analysis.|||pg/mL||95% Confidence Interval|Mean
2827890|NCT00319748|Secondary|Mean Difference Values for Soluble CD40 Ligand (sCD40L)|Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have recorded value at 6 hours after treatment and cannot be included in analysis.|||pg/mL||95% Confidence Interval|Mean
2827891|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)|Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Two patients did not have recorded values at 6 hours after treatment so cannot be included in analysis.|||pg/mL||95% Confidence Interval|Mean
2827892|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)|Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 5 patients had a value reported at 6 hours after treatment.|||pg/mL||95% Confidence Interval|Mean
2827893|NCT00319748|Secondary|Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)|Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have a value reported at 6 hours after treatment so cannot be included in analysis.|||pg/mL||95% Confidence Interval|Mean
2827894|NCT00319748|Secondary|Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)|Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 hours after Dose 1|One patient did not have value reported at 6 hours after treatment, so cannot be included.|||pg/mL||95% Confidence Interval|Mean
2827895|NCT00319748|Primary|Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.|Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.|after 12 weeks (24 doses of 852A)|Includes only patients that received all 24 doses of 852A.|||Participants|||Number
2827896|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Squamous Cell|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB|||percentage of participants|||Number
2827897|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB|||percentage of participants|||Number
2827906|NCT00319696|Secondary|Serious Adverse Events up to 28 Days After Last Study Medication|Number of patients with at least one treatment-emergent serious adverse event (TESAE) were reported. TESAEs are serious AEs that occurred after study drug initiation and up to 28 days after study drug discontinuation. More details on the SAEs are provided in the specific Adverse Events Section|80 weeks||||Participants|||Number
2827907|NCT00319696|Secondary|Adverse Events Leading to Permanent Discontinuation of the Study Medication|Number of patients with an adverse event leading to permanent discontinuation of the study treatment|80 weeks|Study population|||participants|||Number
2827908|NCT00319696|Secondary|Adverse Events up to 24 Hours After Last Study Medication|Number of patients with at least one treatment-emergent adverse event. All adverse events that occurred after study drug initiation and up to 24 hours after study drug discontinuation were to be recorded.|80 weeks|Study population|||participants|||Number
2827909|NCT00319696|Primary|Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits|The total number of new DUs per patient observed by the investigator at planned visits and new transient DUs recorded in the patient diary (a patient diary was used to record DUs that might appear and disappear between two planned visits) were assessed at each clinic visit|At planned visits up to week 80|One patient did not have a DU at baseline (number of patients assessed at Weeks 0-4,4-8,8-16,16-24,24-32,32-40,40-48,48-56,56-64,64-72, and 72-80 were 114, 107, 103, 100, 97, 94, 88, 87, 86, 86, and 83, respectively.|||number of new digital ulcers|||Number
2827910|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS)|"UKFS relates to upper and lower extremity function and muscle weakness. For each item, the patient indicated the responses that best described their current ability: able to perform in a normal manner, able to perform with alteration in style, can only manage with difficulty, and impossible to achieve. Each response was given an integer from 0 (able to perform in a normal manner) to 3 (impossible to achieve), and the sum of individual responses provided an overall score of 0 to 33. Missing values were replaced with the worst value the patient reported on the other items at that visit."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 98, 93, 84, 82, and 78, respectively|||score on a scale||Standard Deviation|Mean
2827911|NCT00319696|Primary|Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers|"Overall hand pain related to finger ulcers was assessed by the patient using a Visual Analogue Scale. Patients were instructed to score their pain by marking on the continuous 10-cm scale, where 0 (left) was no pain and 100 (right) very severe pain, in response to the question, How much pain have you had because of your finger ulcers in the past week? The investigator measured the distance in millimeters between 0 and the patient mark with the ruler provided and recorded the distance."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 110, 94, 89, 81, 76, and 73, respectively|||mm||Standard Deviation|Mean
2827912|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827913|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827914|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827915|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827916|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827917|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827918|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827919|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively|||scores on a scale||Standard Deviation|Mean
2827920|NCT00319696|Primary|Time to Complete Healing of Each New DU||New DU occurence to healing|Complete healing of each new DU was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on DU healing originally planned time to complete healing of new DUs was not evaluated.||||||
2827921|NCT00319696|Primary|Time to Complete Healing of Each Baseline DU||Baseline to healing|Complete healing of each baseline was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on time to complete healing of baseline DUs was not evaluated.||||||
2827922|NCT00319644|Primary|Antibiotics Exposure Days|We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure|15 days|Random|||days||Standard Deviation|Mean
2827923|NCT00319644|Primary|Change in Antibiotic Usage or Exposure|We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have >80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).|It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics|Of the 37 adult critically ill patients, 21 belonged to the tracheal aspirate (TA) group and 16 patients were classified as mini-BAL (MB) group.|||days||Standard Deviation|Mean
2827924|NCT00319592|Primary|Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®|Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.|Day 0 up to Day 6 post-vaccination|Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).|||Participants|||Number
2827925|NCT00319592|Primary|Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) up to month 12 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).|||1/dilutions||Standard Deviation|Mean
2827926|NCT00319592|Primary|Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']|Day 0 (Pre-vaccination) and up to Month 12 After First Dose|Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).|||Participants|||Number
2827927|NCT00319592|Primary|Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 up to Day 56 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population).|||1/dilutions||Standard Deviation|Mean
2828472|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
2827928|NCT00319592|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.|Day 0 (pre-vaccination) and up to Day 56 post-vaccination|Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).|||Participants|||Number
2827929|NCT00319553|Primary|Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population|||EU/mL||95% Confidence Interval|Geometric Mean
2827930|NCT00319553|Primary|Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Diphtheria antitoxin concentrations were analyzed in the per-protocol population|||Percentage of Participants|||Number
2827931|NCT00319553|Primary|Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Tetanus antitoxin concentrations were analyzed in the per-protocol population.|||Percentage of Participants|||Number
2827932|NCT00319553|Primary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®|"Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities."|Day 0 to 7 post-vaccination|Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population|||Participants|||Number
2827933|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Open-label Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for evaluation.|||Units on a scale||Standard Deviation|Mean
2827934|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Open-label Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for participation.|||Units on a scale||Standard Deviation|Mean
2827935|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.|||Participants|||Number
2827936|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Open-label Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient's diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.|||Participants|||Number
2827937|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Open-label Period|Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode.|From 15 minutes to 12 hours after study drug administration during the Open-label Period|All randomized participants in whom an attempt (successful or not) was made to administer study drug for an ARS episode during the Open-label Period of the study.|||Participants|||Number
2828007|NCT00318708|Secondary|Methacholine Provocative Concentration (PC20)|Logarithm-base 2 transformed Methacholine provocative concentration (PC20) based on FEV1|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||logarithm-base 2 of mg/mL||Standard Error|Least Squares Mean
2827938|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Double-blind Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes. The physician global evaluation is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|At Visit 2 and subsequent visits in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.|||Units on a scale||Standard Deviation|Mean
2827939|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.|||Units on a scale||Standard Deviation|Mean
2827940|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.|||Participants|||Number
2827941|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Double-blind Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient's diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.|||Participants|||Number
2827942|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Double-blind Period|If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the acute repetitive seizure (ARS) episode. Each patient's specific criteria for seizure and an episode of ARS were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS during the Double-blind Period.|||Participants|||Number
2827943|NCT00319501|Primary|Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.|||Percentage of participants|||Number
2828008|NCT00318708|Secondary|Forced Expiratory Volume in One Second (FEV1)|Forced expiratory volume in one second (FEV1) from spirometry|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||Liters||Standard Error|Least Squares Mean
2827944|NCT00319501|Primary|Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.|||Hours||95% Confidence Interval|Median
2827945|NCT00319449|Secondary|High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.|6 weeks post treatment|Participants who completed the study.|||mg/dL||95% Confidence Interval|Mean
2827946|NCT00319449|Secondary|Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.|6 weeks post treatment|Participants who completed the study.|||Participants|||Number
2827947|NCT00319449|Primary|Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.|Baseline and 6 weeks|Participants who completed the study.|||mg/dL||95% Confidence Interval|Mean
2827948|NCT00319436|Secondary|Maternal Substance Abuse (Assessed With Urine Toxicology Screens)|"Maternal substance use was monitored weekly using results from weekly urine toxicology (UTOX) screens testing for presence of opiate, cocaine, and cannabis metabolites in urine samples collected at the outpatient clinic. For each month of the mother's participation in the study, a mother received a score of 0 if no drug metabolites were present in any of her urine toxicology screens during that month or a score of 1 if one or more of her urine toxicology screens tested positive for a drug metabolite during that month. A percentage was calculated by= number of positive substance tests/number of total test *100 for each patients during each month."|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||% positive utox screens/month||Standard Error|Mean
2827949|NCT00319436|Secondary|Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)|The Brief Symptom Inventory (BSI; Derogatis, 1993) was used to assess maternal global psychiatric distress. The BSI is a standardized, widely used, 53-item, 5-point, self-report measure of psychopathology. The composite Global Severity Index (GSI) measures current overall symptomatology across multiple domains and has demonstrated good reliability and validityT-scores have a mean of 50 and a standard deviation of 10. Scores within one standard deviation (ie. a T-score of 10) above the mean on any dimension are regarded as being within the normal range on that dimension (Derogatis, 1993). These scores were converted to T-scores using data from the scoring manual. The higher the scores are worse.T scores above 60 on the GSI indicate risk for a clinical disorder.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
2827950|NCT00319436|Secondary|Maternal Depression (Measured With the Beck Depression Inventory)|The Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
2827951|NCT00319436|Secondary|Child Behavior (Assessed With the NCAST Teaching Scales)|Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales (23 items) with scores ranging from 0 to 23. The Child Contingency Score is the sum of 12 contingent items from the 2 scales (with scores ranging from 0 - 12). The 2 subscores are summed to arrive at the composite score. Higher scores are better. The normative means for the children of high school educated mothers reported in the scoring manual: Total Child Score = 15.44 (4.29), Clarity of Cues = 7.99 (1.49), Responsiveness to Parent = 7.45 (3.16).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
2827952|NCT00319436|Secondary|Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)|Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, & Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores (73 items) with scores ranging from 0 to 73. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver's contingent response to child cues (scores range from 0 to 20). Higher score are better and lower scores are worse. For mothers with high school education (which a majority in our sample had) here are the normative means (SDs) reported in the scoring manual: Total Caregiver Score = 40.69 (6.85), Sensitivity to Cues = 9.16 (1.62), Response to Distress = 10.04 (1.78), Social-Emotional Growth = 8.99 (1.83), Cognitive Growth = 12.51 (3).|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
2827953|NCT00319436|Primary|Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)|The Working Model of the Child Interview (WMCI; Zeanah & Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother's perceptions of her child and their relationship. The rater was trained to reliably code 6 qualitative subscales: Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
2827954|NCT00319436|Primary|Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)|The Parent Development Interview (PDI) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.|post-treatment and 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.|||units on a scale||Standard Deviation|Mean
2827955|NCT00319254|Other Pre-specified|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24|||||||
2827956|NCT00319254|Secondary|Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment|KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.|Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.||||||
2827957|NCT00319254|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.|Day 1 up to end of treatment (Week 77)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.||||||
2827958|NCT00319254|Secondary|Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations|Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate >25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of >=7% in body weight.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."|||participants|||Number
2827959|NCT00319254|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG)|Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate >=120 beats per minute (bpm) or increase >=15 bpm; QT interval corrected using Bazett's formula (QTcB) >60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."|||participants|||Number
2828009|NCT00318708|Secondary|AM Peak Expiratory Flow (PEF)|daily AM peak expiratory flow (PEF) measured in liters per minute|the week-16 average minus the baseline-week average|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||liters per minute||Standard Error|Least Squares Mean
2827960|NCT00319254|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin >3*ULN micromole/L; sodium <130, magnesium <0.4 and >1.23 millimole/L; lipase >2*ULN microkats/L; neutrophils <1*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."|||participants|||Number
2827961|NCT00319254|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD >24 weeks at any time while on study was counted in the numerator.|Baseline up to end of treatment (Week 77)|ITT population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2827962|NCT00319254|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline up to Year 1|ITT population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2827963|NCT00319254|Secondary|Overall Survival (OS)|OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.|Baseline up to Year 2|ITT population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2827964|NCT00319254|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 30 days after last dose of study treatment|Safety population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2827965|NCT00319254|Primary|Progression-Free Survival (PFS) Rate|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.|Baseline up to Week 16|Intent-To-Treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2827966|NCT00319111|Secondary|Occurrence of Liver Function Test and Hemoglobin Abnormality|Number of patients with an increase in liver aminotransferases to >3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to ≤10 g/dL|Until discontinuation of study drug, up to 3.3 years|study population|||participants|||Number
2827967|NCT00319111|Secondary|Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation||28 days after discontinuation of study drug, up to 3.3 years|Study population|||participants|||Number
2827968|NCT00319111|Secondary|Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication||Until discontinuation of study drug, up to 3.3 years|Study population|||participants|||Number
2827969|NCT00319111|Primary|Time to Clinical Worsening up to End-of-study|An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier.|Until discontinuation of study drug, up to 3.3 years|Study population|||participants|||Number
2827970|NCT00319111|Primary|Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)|"Disease severity was assessed by WHO classification of PH criteria:~Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope.~Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.~Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.~Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA."|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 138, 129, 123, 109, and 139 respectively|||participants with improved WHO class|||Number
2827971|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in Borg Dyspnea Index|Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 [nothing at all], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 [maximum ever experienced]).|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 136, 127, 120, 105, and 136 respectively|||Scores on a scale||Standard Deviation|Mean
2827972|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance|Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period.|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 137, 128, 121, 106, and 137 respectively|||walk distance change from baseline (m)||Standard Deviation|Mean
2827973|NCT00319098|Secondary|Number of Seroprotected Subjects Against A/Vietnam Influenza Strain|Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.|At Day 0 (PRE), Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Participants|||Count of Participants
2827974|NCT00319098|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.|At Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Titer fold increase||95% Confidence Interval|Geometric Mean
2827975|NCT00319098|Secondary|Number of Seroconverted Subjects Against H5N1|Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.|At Day 21 and Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Participants|||Count of Participants
2827976|NCT00319098|Secondary|Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1|Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).|At Day 0 (PRE), 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2827977|NCT00319098|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Day 51|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available at Day 51.|||Participants|||Count of Participants
2827978|NCT00319098|Primary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180|The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.|||Participants|||Count of Participants
2827979|NCT00319098|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Day 180|The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.|||Participants|||Count of Participants
2827980|NCT00319098|Primary|Number of Subjects With AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.|During the 30 Day (Days 0-29) post Dose 2|The analysis was performed on the TVc which included all subjects who had received the second dose and for whom data were available.|||Participants|||Count of Participants
2827981|NCT00319098|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.|During the 21st Day (Days 0-20) post Dose 1|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in at Day 51.|||Participants|||Count of Participants
2828010|NCT00318708|Secondary|Asthma Rescue Medication Use|number of rescue puffs per day|the week-16 average minus the baseline-week average|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||rescue puffs per day||Standard Error|Least Squares Mean
2827982|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Across Doses)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) post vaccination across dosses|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
2827983|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Dose 2)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) after Dose 2|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
2827984|NCT00319098|Primary|Number of Subjects With Solicited General Symptoms (Dose 1)|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.|During the 7-day (Days 0-6) after Dose 1|The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
2827985|NCT00319098|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter|During a 7 day follow-up period after each dose of vaccine and overall.|The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.|||Participants|||Count of Participants
2827986|NCT00319046|Secondary|Mean Percent Change From Baseline in Spleen Volume|"Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging.~Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the 'worst' within-patient value not more than 2 days after the end of treatment was used to impute the missing value."|End of treatment (Month 24)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat|||Percentage change||Standard Deviation|Mean
2827987|NCT00319046|Secondary|Spleen Volume at Baseline and End of Treatment|"Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging.~Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the 'worst' within-patient value not more than 2 days after the end of treatment was used to impute the missing value."|Baseline and end of treatment (Month 24)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat|||cm^3||Standard Deviation|Mean
2827988|NCT00319046|Primary|Mean Within-patient Percent Change From Baseline in Liver Volume|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging. Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the 'worst' within-patient value not more than 2 days after the end of treatment was used to impute the missing value.|End of treatment (Month 24)|One patient was excluded from analysis as the baseline liver volume not available|||Percentage change||Standard Deviation|Mean
2827989|NCT00319046|Primary|Liver Volume at Baseline and at End of Treatment|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging. Imputation methods for patients with missing values at Month 24 were applied as follows: if a patient had at least 640 days of treatment with the study drug, the last observation that was not more than 2 days after the end of treatment was carried forward. If a patient had discontinued study drug before Day 640, the 'worst' within-patient value not more than 2 days after the end of treatment was used to impute the missing value.|Baseline and end of treatment (Month 24)|One patient was excluded from analysis as the baseline liver volume not available|||cm^3||Standard Deviation|Mean
2827990|NCT00319020|Primary|Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment||From the first study drug administration in FUTURE 1, for an average of 31 months||||Participants|||Number
2827991|NCT00319020|Primary|Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities|"The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities.~Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here."|After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Percentage of participants|||Number
2828473|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
2827992|NCT00319020|Primary|Proportion of Patients With Treatment-emergent Liver Function Abnormalities|"The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes.~Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here."|After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Percentage of participants|||Number
2827993|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Pulse Rate|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in pulse rate.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Beats per minutes||Full Range|Median
2827994|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP)|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||mmHg||Full Range|Median
2827995|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP)|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||mmHg||Full Range|Median
2827996|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Body Weight|The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height.|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||kg||Full Range|Median
2827997|NCT00319020|Primary|Change From Baseline to End of Study (EOS) in Height for Age.|"In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula:~Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population"|From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average|All-treated analysis set (all patients who received at least one dose of study drug in the combined FUTURE 1 / FUTURE 2 trial periods). Missing or incomplete data were treated as missing.|||Z-score||Full Range|Median
2827998|NCT00318929|Secondary|Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)|Seizure Severity Questionnaire summary score, on a scale of 1 to 7 with one being the least severe and 7 being the most severe, components of seizures include; warning, activity and recovery|24 weeks|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.||||||
2827999|NCT00318929|Secondary|Number of Seizures Per Month|Count of seizures per month determined by seizures recorded in diaries.|24 weeks|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.||||||
2828000|NCT00318929|Secondary|Patient's Compliance With Once a Day Dosing.|Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.|24 weeks|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.||||||
2828001|NCT00318929|Primary|Effectiveness of Medication as Measured by Participation Through the End of the Trial.|Number of participants completing the trial|24 weeks||||participants|||Number
2828002|NCT00318812|Secondary|Transferrin Saturation|Comparison of Transferrin Saturation between the Groups|6 Months||||percentage of bound iron sites||Inter-Quartile Range|Median
2828003|NCT00318812|Secondary|Ferritin|Comparison of Ferritin at 6 months between the 2 Groups|6 months||||ug/L||Inter-Quartile Range|Median
2828004|NCT00318812|Primary|Hemoglobin Concentration at 6 Months||6 months||||g/L||Inter-Quartile Range|Median
2828005|NCT00318708|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 questions, with each question ranging from 1 (worst) to 7 (best). The 32 questions are averaged to yield an overall score, which is reported here. Therefore, a positive change between the 16-week score and the baseline score represents improvement.|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||units on a scale (1 through 7)||Standard Error|Least Squares Mean
2828006|NCT00318708|Secondary|Exhaled Nitric Oxide (eNO)|Exhaled nitric oxide (eNO) measured in parts per billion|the week-16 value minus the baseline-value|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||parts per billion||Standard Error|Least Squares Mean
2828474|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 weeks||||SF-36 General Health Score||Inter-Quartile Range|Median
2828011|NCT00318708|Primary|Juniper Asthma Control Questionnaire (ACQ) Results|The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.|Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).|||units on a scale||Standard Error|Least Squares Mean
2828012|NCT00318656|Secondary|Glycaemia According to CGMS (MAGE), mg/dL|Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828013|NCT00318656|Secondary|Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828014|NCT00318656|Secondary|Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828015|NCT00318656|Secondary|Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828016|NCT00318656|Secondary|Glycaemia According to CGMS (Dawn), mg/dL|"Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia at dawn measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time."|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828017|NCT00318656|Secondary|Glycaemia According to CGMS (Diurnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828018|NCT00318656|Secondary|Glycaemia According to CGMS (Nocturnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)|||mg/dL||Standard Error|Mean
2828019|NCT00318656|Secondary|8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate|8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)|||pg/mL||Standard Error|Mean
2828020|NCT00318656|Secondary|HbA1c (Glycosylated Hemoglobin)|Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital|Baseline and 12 weeks|ITT (randomized)|||Percentage||Standard Error|Mean
2828021|NCT00318656|Secondary|Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
2828022|NCT00318656|Secondary|Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Hours||Standard Error|Mean
2828023|NCT00318656|Secondary|Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
2828024|NCT00318656|Secondary|Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Hours||Standard Error|Mean
2828025|NCT00318656|Secondary|Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
2828026|NCT00318656|Secondary|Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Hours||Standard Error|Mean
2828027|NCT00318656|Primary|Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)|||Episodes||Standard Error|Mean
2828126|NCT00317109|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Months 15-18 and up to Months 25-31 post vaccination|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.|||Subjects|||Number
2828028|NCT00318656|Primary|Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized): This Intent-to-treat (ITT) population included all subjects who had been randomised, who had received at least one dose of study medication, and for whom at least one efficacy criteria on treatment period was available. The ITT population was the primary population for the efficacy analysis.|||Hours||Standard Error|Mean
2828029|NCT00318591|Secondary|Number of Participants With One or More Urinary Tract Infection||4-6 months||||participants|||Number
2828030|NCT00318591|Secondary|Device-related or Possibly Device-related AEs||4-6 months||||Events|||Number
2828031|NCT00318591|Secondary|Nurse Time Spent on Catheterization Procedure||4-6 months|ITT-population|||seconds||Standard Deviation|Mean
2828032|NCT00318591|Secondary|Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|ITT population|||scores on a scale||Standard Deviation|Mean
2828033|NCT00318591|Secondary|Nurse Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|Analysis were done on evaluations of the ITT-population. Evaluations were made at discharge from hospital. Since some participants discontinued the study prior to discharge and since some did not fill in the evaluation form, the total number of evaluations (132) do not add up to the total of the ITT population (219)|||scores on a scale||Standard Deviation|Mean
2828034|NCT00318591|Secondary|UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml|UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis|4-6 months|Descriptive only|||UTI|||Number
2828035|NCT00318591|Primary|Occurrence of Symptomatic Urinary Tract Infections (UTIs)|Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI|4-6 months|ITT-population, symptomatic urinary tract infections treated with antibiotics|||participants|||Number
2828036|NCT00318565|Primary|Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.|The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.|7 Days||||percentage of participants||95% Confidence Interval|Mean
2828037|NCT00318565|Primary|Percentage of Subjects With Complete Bidirectional Conduction Block.|Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.|During the procedure|"Per protocol analysis. Number differs from Participant Flow because only 253 subjects were considered for the efficacy cohort."|||percentage of participants||95% Confidence Interval|Mean
2828038|NCT00318474|Secondary|Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level||12 months|||||||
2828039|NCT00318474|Primary|Change in Proteinuria - Uprotein/Creatinine Ratio|Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.|Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.||||ratio||Standard Deviation|Mean
2828040|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 104|Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-104|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.|||episodes|||Number
2828041|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.|||episodes|||Number
2828042|NCT00318461|Secondary|Change in Beta-cell Function at Week 104|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point (%point)||Standard Error|Least Squares Mean
2828043|NCT00318461|Secondary|Change in Beta-cell Function at Week 26|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point (%point)||Standard Error|Least Squares Mean
2828074|NCT00318149|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm).|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
2828044|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
2828045|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
2828046|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
2828047|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 104|Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage of total haemoglobin||Standard Error|Least Squares Mean
2828048|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/l||Standard Error|Least Squares Mean
2828049|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 104|Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
2828050|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mmol/L||Standard Error|Least Squares Mean
2828051|NCT00318461|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
2828052|NCT00318461|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
2828053|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
2828054|NCT00318409|Primary|Acceptability: Proportion of Participants Discontinuing Medication in Both Arms|Proportion of participants who discontinued study medication for at least one week prior to study completion.|12 weeks||||percentage of discontinuations|||Number
2828055|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report|Proportional of reported days taking study drug during the 12 weeks of study.|12 weeks||||percentage of self-reported adherence|||Number
2828056|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings|Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.|12 weeks||||percentage adherence by MEMS|||Number
2828057|NCT00318409|Primary|Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.||throughout study||||number of adverse events|||Number
2828058|NCT00318409|Primary|Feasibility: Participants Who Completed the Trial||12 weeks||||participants who completed the trial|||Number
2828059|NCT00318409|Primary|Feasibility: Proportion of Urine Samples Collected||12 weeks||||Urine samples collected|Participants||Number
2828060|NCT00318409|Primary|Feasibility: Proportion of Scheduled Study Visits Completed||12 weeks||||Scheduled study visits completed|Participants||Number
2828061|NCT00318409|Primary|Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled||At Enrollment||||Eligible persons screened who enrolled|||Number
2828062|NCT00318370|Secondary|Percentage of Participants Who Had a Prolongation of Remission|Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator's assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.|||percentage of participants||95% Confidence Interval|Number
2828063|NCT00318370|Secondary|Progression-free Survival (PFS)|PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 >2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.|||Months||95% Confidence Interval|Median
2828064|NCT00318370|Secondary|Overall Response Rate|"The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR."|Baseline to response (up to 44 months)||||percentage of participants|||Number
2828065|NCT00318370|Secondary|Duration of Serologic Response (CA-125)|Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being >2 X ULN on two occasions.|Baseline to response (up to 44 months)|All participants enrolled to initial chemotherapy plus farletuzumab.|||Months||95% Confidence Interval|Median
2828066|NCT00318370|Secondary|Time to Serologic Response (Change in CA-125 Level)|Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.|Baseline to response (up to 27 weeks)|All participants enrolled to intial chemotherapy plus farletuzumab.|||Weeks||95% Confidence Interval|Median
2828067|NCT00318370|Primary|Serologic Response (Change in Cancer Antigen [CA-125] Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 27 weeks)|All participants enrolled to chemotherapy plus farletuzumab.|||participants|||Number
2828068|NCT00318370|Primary|Serologic Response (Change in CA125 Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 30 weeks)|All participants enrolled to initial farletuzumab only.|||participants||95% Confidence Interval|Number
2828069|NCT00318357|Primary|All Cause Mortality|"Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial.~The patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000."|8-year|Data from the CARE-HF and CARE-HF Long-Term Follow-Up studies were combined for analysis|||percentage of participants|||Number
2828070|NCT00318292|Primary|Visual Analogue Scale (VAS) Pain Score|Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.|30 minutes post-op||||points on a scale||Standard Deviation|Mean
2828071|NCT00318149|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
2828072|NCT00318149|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination.|During the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
2828073|NCT00318149|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever >39°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.|||Participants|||Count of Participants
2828085|NCT00318136|Secondary|Adverse Events That Led to Discontinuation of Bevacizumab|Any treatment-emergent adverse event leading to study treatment discontinuation|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients|||Patients|||Number
2828075|NCT00318149|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Participants|||Count of Participants
2828076|NCT00318149|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 0 and at Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Participants|||Count of Participants
2828077|NCT00318149|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Fold change||95% Confidence Interval|Geometric Mean
2828078|NCT00318149|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Fold change||95% Confidence Interval|Geometric Mean
2828079|NCT00318149|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Participants|||Count of Participants
2828080|NCT00318149|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Participants|||Count of Participants
2828081|NCT00318149|Secondary|Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).~Seropositivity was defined as a serum HI titer of ≥ 1:10."|At Day 90 and Day 180|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.|||Titers||95% Confidence Interval|Geometric Mean
2828082|NCT00318149|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).~Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10."|At Day 0 and at Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||Titers||95% Confidence Interval|Geometric Mean
2828083|NCT00318149|Primary|Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers|The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).|||T-cells/million cells||Standard Deviation|Geometric Mean
2828084|NCT00318136|Secondary|Progression-free Survival|"Progression−free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab.~Summary of PFS (median) was estimated from Kaplan−Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley."|Length of study|Enrolled patients|||Months||95% Confidence Interval|Median
2828086|NCT00318136|Secondary|Selected Adverse Events|"Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions.~Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients|||Patients|||Number
2828087|NCT00318136|Primary|Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events|"To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients|||Percentage of patients|||Number
2828088|NCT00317941|Secondary|Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants|"if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction.~An injection site is seen as developing no reaction if the patient's score for this site is of a reaction intensity = 0."|Up to 3 months assessed every 48 hours after each injection||||Percentage of sites|Participants||Number
2828089|NCT00317941|Secondary|Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants||Up to 3 months assessed every 24 hours after each injection||||Percentage of sites|Participants||Number
2828090|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|24h after injection||||Scores on a scale||Full Range|Mean
2828091|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|1h after injection||||Scores on a scale||Full Range|Mean
2828092|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|30 min after injection||||Scores on a scale||Full Range|Mean
2828093|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|Immediately after injection||||Scores on a scale||Full Range|Mean
2828094|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection||||Percentage of injection sites|Participants||Number
2828095|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Physicians||Up to 3 months||||Percentage of injection sites|Participants||Number
2828096|NCT00317941|Secondary|Percentage of Participants Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection||||Percentage of participants|||Number
2828097|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 48 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 48 hours after each injection||||Percentage of sites|Participants||Number
2828098|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 24 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 24 hours after each injection||||Percentage of sites|Participants||Number
2828099|NCT00317941|Secondary|Percentage of Participants Without ISR Reported by Participants||Up to 3 months assessed every 24 hours after each injection||||Percentage of participants|||Number
2828100|NCT00317941|Secondary|Percentage of Injection Sites Per Participant With Reaction Reported by Physicians||Up to 3 months||||Percentage of ISR|Participants||Number
2828101|NCT00317941|Secondary|Percentage of Injection Sites With Pain Reported by Physicians||Up to 3 months||||Percentage of sites|Participants||Number
2828102|NCT00317941|Other Pre-specified|Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months||||Scores on a scale|Participants|Standard Deviation|Mean
2828103|NCT00317941|Primary|Mean Scores of Reaction After Injection Reported by Participants|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months assessed every 24 and 48 hours after injection||||Scores on a scale|Participants|Standard Deviation|Mean
2828104|NCT00317941|Primary|Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection|An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 48 hours after each injection||||Percentage of sites|Participants||Number
2828105|NCT00317941|Primary|Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection|An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 24 hours after each injection||||Percentage of sites|Participants||Number
2828123|NCT00317473|Primary|Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination|Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period|40 days||||events|||Number
2828124|NCT00317239|Primary|Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL||anytime during the study|Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²|||participants|||Number
2828106|NCT00317720|Primary|Clinical Benefit Response Rate (CBR)|Efficacy measured by the clinical benefit response rate (CBR), defined as confirmed Complete Response (CR) plus Partial Response (PR) at any time plus Persistent Stable Disease (pSD). Confirmed CR is defined as disappearance of all target lesions at the time of radiographic evaluation; pSD was defined as SD lasting 24 weeks. Complete Response (CR): disappearance of all target lesions, and Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as a reference the baseline sum LD. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started.|6 weeks||||percentage of partcipants|||Number
2828107|NCT00317720|Primary|Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)|"In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized.~Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common Terminology Criteria (CTC) version 3.0 except fatigue. Participants underwent clinical evaluation every 3 weeks (one cycle) and radiologic evaluations every 6 weeks. After the second cycle, participants underwent a radiologic evaluation using the same imaging technique used at initial evaluation (ie, computed tomography or magnetic resonance imaging)."|Following two 3 week cycles of therapy|At MDACC, sixteen participants total treated at 10 mg (dose level 1) in the Phase I portion of the study with the remainder thirty-four registered in Phase II. At DFCI/BIDMC, the first three participants were included in the Phase I portion of the study, the remaining four of seven registered were in Phase II.|||mg|||Number
2828108|NCT00317642|Secondary|Participants With Adverse Events (CSR 7-April-11)|"Number of participants with treatment emergent adverse events (TEAEs) or death due to related AE. Related AEs for the combination arm can be related to either clofarabine or cytarabine.~Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life Threatening AE, Grade 5 = Death"|Day 1 up to a maximum of 4 years (includes up to a maximum of 3 cycles of therapy plus 45 days follow up. Related AEs are followed to resolution.)|Safety Set - Participants in the Full Analysis Set (FAS) who received at least 1 dose of study drug.|||participants|||Number
2828109|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, that is the strata include the IVRS mistakes.|||percentage of participants|||Number
2828110|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||percentage of participants|||Number
2828111|NCT00317642|Secondary|Event-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
2828112|NCT00317642|Primary|Overall Survival - Overall and by Randomized Strata (CSR 9-July-12)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 randomized strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS) - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
2828113|NCT00317642|Secondary|Event-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||months||95% Confidence Interval|Median
2828114|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.~See Outcome #3 for definition of CR and CRi.~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
2828115|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.~See Outcome #3 for definition of CR and CRi.~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.|||months||95% Confidence Interval|Median
2828116|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Randomized Strata (CSR 9-July-12)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.|||months||95% Confidence Interval|Median
2828117|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Calculated Strata (CSR 7-April-11)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.|||months||95% Confidence Interval|Median
2828118|NCT00317642|Secondary|Best Response Per Independent Response Review Panel (IRRP) Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Percentage of participants whose best response was assessed by the IRRP as complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) using the revised International Working Group for Response Criteria (Cheson 2003).~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 up to approximately 6 months|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||percentage of participants|||Number
2828119|NCT00317642|Primary|Overall Survival - Overall and by Calculated Strata (CSR 7-April-11)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.|||months||95% Confidence Interval|Median
2828120|NCT00317473|Secondary|Anti-FMP1 Antibody Titer Responses|Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine|364 days||||titers||95% Confidence Interval|Geometric Mean
2828121|NCT00317473|Primary|Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine|Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine|8 months||||events|||Number
2828122|NCT00317473|Primary|Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination|Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)|90 days||||events|||Number
2828125|NCT00317226|Primary|Incidence of Treatment-emergent Adverse Events||44 week study duration||||each event|||Number
2828127|NCT00317109|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.|||Subjects|||Number
2828128|NCT00317109|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.|During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.|||Subjects|||Number
2828129|NCT00317109|Secondary|Number of Subjects With Solicited Local Symtoms|Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.|During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine|The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines and had the symptoms sheet filled in.|||Subjects|||Number
2828130|NCT00317109|Secondary|Number of Subjects With Fever|Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.|During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine|The analysis was performed on the Booster Total Vaccinated Cohort which included all subjects who received at least one of the two vaccines.|||Subjects|||Number
2828131|NCT00317109|Secondary|Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135|Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.|At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2828132|NCT00317109|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2828133|NCT00317109|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).|Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2828134|NCT00317109|Secondary|Anti-PSW Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2828135|NCT00317109|Secondary|Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody concentrations were ≥ 0.3 µg/mL.|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2828136|NCT00317109|Secondary|Anti-PSA and Anti-PSC Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2828137|NCT00317109|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values|Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2828138|NCT00317109|Secondary|Anti-rSBA-MenA, C, W-135 Antibody Titers|Antibody titers were expressed as geometric mean titers (GMTs).|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2828139|NCT00317109|Secondary|Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs|Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.|Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2828140|NCT00317109|Primary|Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies|Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.|At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)|The analysis were performed on the Booster ATP cohort for immunogenicity which included all evaluable subjects who received the 3 vaccine doses in the primary vaccination study, received one of the two vaccines according to the protocol in this booster study and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2828141|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months||||Inhalations||Standard Error|Least Squares Mean
2828142|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months||||Scores on a scale||Standard Error|Least Squares Mean
2828143|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months||||Scores on a scale||Standard Error|Least Squares Mean
2828144|NCT00317044|Secondary|Number of Severe Adverse Events||Up to 6 months||||Events|||Number
2828145|NCT00317044|Secondary|Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7|The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.|Randomization (Visit 3) to Visit 7||||Scores on a scale||Standard Error|Least Squares Mean
2828146|NCT00317044|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7|The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).|From randomization (Visit 3) to Visit 7||||Scores on a scale||Standard Error|Least Squares Mean
2828147|NCT00317044|Secondary|Number of Patients With Severe Asthma Exacerbations.||Up to 6 months||||Participants|||Number
2828148|NCT00317044|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.|Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.|From randomization (Visit 3) to visit 7.||||Liters||Standard Error|Least Squares Mean
2828149|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma|Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.|Baseline to 6 months||||Percent of nights||Standard Error|Least Squares Mean
2828150|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months|This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.|Baseline to 6 months||||Inhalations||Standard Error|Least Squares Mean
2828151|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total|Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.|Baseline to 6 months||||Scores on a scale||Standard Error|Least Squares Mean
2828152|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.|Baseline to 6 months||||L/minute||Standard Error|Least Squares Mean
2828153|NCT00317044|Primary|Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.|Baseline to 6 months||||L/minute||Standard Error|Least Squares Mean
2828154|NCT00316914|Secondary|Change From Baseline in Quality of Life (QOL) at One Month|Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.|||Units on a scale||Standard Deviation|Mean
2828155|NCT00316914|Secondary|Change From Baseline in Fatigue Score at One Month|Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.|||units on a scale||Standard Deviation|Mean
2828156|NCT00316914|Secondary|Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL)|Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom).|127 days|Data was collected but not analyzed for this outcome.||||||
2828157|NCT00316914|Secondary|Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event|Adverse Events were measured using CTCAE V3.0.|127 days|Analyses of adverse events includes all patients. Adverse event data is not available on one patient in Placebo arm, which leads to the total of 51 in Placebo arm for analysis.|||Percentage of Participants|||Number
2828158|NCT00316914|Secondary|Percentage of Patients With Acute Neuropathic Adverse Event|Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy.|127 days|Includes all patients that reported at least one value after baseline.|||Percentage of participants|||Number
2828159|NCT00316914|Secondary|Average Duration of Oxaliplatin-containing Treatment||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.||||||
2828160|NCT00316914|Secondary|Average Cumulative Oxaliplatin Dose||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.||||||
2828161|NCT00316914|Secondary|Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity|Neurotoxicity were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||Percentage of Participants|||Number
2828162|NCT00316914|Secondary|Average Duration of Chronic Neuropathic Toxicity|Neuropathic adverse events were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||days||95% Confidence Interval|Median
2828163|NCT00316914|Secondary|Time to Onset of Grade 3+ Chronic Neurotoxicity|Neurotoxicity was assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||Days||95% Confidence Interval|Median
2828164|NCT00316914|Secondary|Time to Onset of Grade 2+ Chronic Neurotoxicity|Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|127 days|Includes all patients that reported at least one value after baseline.|||Days||95% Confidence Interval|Median
2828165|NCT00316914|Primary|Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event|Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4)|127 days|Efficacy analyses use all patients that reported at least one value after baseline.|||Percentage of participants|||Number
2828166|NCT00316888|Secondary|3-year Colostomy-free Survival Rate|Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients who did not have permanent colostomy at study entry|||proportion of participants||95% Confidence Interval|Number
2828167|NCT00316888|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2828168|NCT00316888|Secondary|3-year Progression-free Survival Rate|Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2828169|NCT00316888|Secondary|3-year Overall Survival Rate|Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2828170|NCT00316888|Primary|Local Failure Rate at 3 Years|Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients|||proportion of participants||80% Confidence Interval|Number
2828171|NCT00316862|Secondary|Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity|Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0|Up to 5 years|1 participant was not evaluated for adverse events.|||percentage of participants|||Number
2828172|NCT00316862|Secondary|Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis|Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 5 years|1 participant was not evaluated for adverse events.|||percentage of participants|||Number
2828173|NCT00316862|Secondary|Patterns of Failure||Up to 5 years|||||||
2828174|NCT00316862|Secondary|Overall Survival||Up to 5 years|||||||
2828175|NCT00316862|Secondary|Disease-free Survival||Up to 5 years|||||||
2828176|NCT00316862|Secondary|Utility of Early PET Imaging in Predicting Response to Treatment||Up to 55 days|||||||
2828177|NCT00316862|Primary|Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery|A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor|Up to 5 years|27 participants with adenocarcinoma were recruited and evaluated for the primary outcome per protocol design.|||percentage of participants||95% Confidence Interval|Number
2828178|NCT00316719|Secondary|Rate of Emergence of Resistant Virus at Week 52|Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene|Week 52|PPS|||Percentage of participants|||Number
2828179|NCT00316719|Secondary|Time to Onset of ALT Normalization|Time to onset of ALT normalization was summarized using the Kaplan-Meier method.|From Baseline to Week 52|PPS: Participants with abnormal ALT value (>ULN) at baseline|||Week 52||95% Confidence Interval|Median
2828180|NCT00316719|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52|ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline|Week 52|PPS: Participants with an abnormal ALT value (>ULN) at baseline|||Percentage of participants|||Number
2828181|NCT00316719|Secondary|Mean Alanine Aminotransferase (ALT) Level at Week 52|Summary statistics were displayed for serum ALT.|Week 52|PPS|||Units per Liter||Standard Deviation|Mean
2828182|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg and negative for HBsAb at baseline|||percentage of participants|||Number
2828183|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg at baseline|||percentage of participants|||Number
2828184|NCT00316719|Secondary|Time to Onset of HBeAg/Ab Seroconversion|Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52|||||||
2828185|NCT00316719|Secondary|Time to Onset of HBeAg Loss|Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52|||||||
2828186|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBeAg and negative for HBeAb at baseline|||Percentage of participants|||Number
2828187|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method|Week 52|PPS: participants who were positive for HBeAg at baseline|||percentage of participants|||Number
2828188|NCT00316719|Secondary|Time to Onset of HBV DNA Loss (< 400 Copies/mL)|Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0|From Baseline to Week 52|||||||
2828189|NCT00316719|Secondary|Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52|The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52|Week 52|PPS|||Percentage of participants|||Number
2828190|NCT00316719|Primary|Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52|Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52|Baseline and Week 52|Per Protocol Set (PPS): participants in the Full Analysis Set (all subjects who entered the study, received at least one dose of investigational product, and had at least one efficacy assessment after the treatment initiation) population with no major protocol violations|||log10 copies/mL||Standard Deviation|Mean
2828191|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up|"Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 24 to Month 48|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.|||Subjects|||Number
2828192|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 18 to Month 24|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point.|||Subjects|||Number
2828193|NCT00316706|Secondary|Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Month 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2828194|NCT00316706|Secondary|Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2828195|NCT00316706|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At 18, 24, 36 and 48 months|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2828196|NCT00316693|Secondary|Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples|"Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows:~Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+).~Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+).~Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).~Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).~Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+).~Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).~Normal ranges indicated by asterix*."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
2828197|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters|"Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined.~Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH)."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
2828198|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters|"Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.~Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
2828199|NCT00316693|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|Throughout the study period (up to Month 24)|Analysis was performed on those subjects reporting pregnancy during the study period.|||Participants|||Count of Participants
2828200|NCT00316693|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
2828201|NCT00316693|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
2828202|NCT00316693|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Total Vaccinated Cohort.|||Participants|||Count of Participants
2828203|NCT00316693|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.|Within 7 days after each and any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.|||Participants|||Count of Participants
2828204|NCT00316693|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0, 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2828205|NCT00316693|Secondary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value|Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.|At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.|||Participants|||Count of Participants
2828206|NCT00316693|Secondary|Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828207|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828208|NCT00316693|Secondary|Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6].~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828209|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828210|NCT00316693|Secondary|Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection|Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828211|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection|Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828212|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828251|NCT00316524|Primary|Number of Participants With ECG Changes|Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6).|within 2 weeks after each vaccination|Safety dataset|||participants|||Number
2828213|NCT00316693|Primary|Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6].|Throughout the study period (up to Month 24)|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.|||Participants|||Count of Participants
2828214|NCT00316602|Secondary|Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination|Occurrence of unsolicited non-serious AEs by relationship to study vaccine|within 29 days after any vaccination|Safety Analysis Set|||events|||Number
2828215|NCT00316602|Secondary|Number of Unsolicited Non-serious Adverse Events: Intensity|Occurrence of unsolicited non-serious AEs by Intensity|within 29 days after any vaccination|Safety Analysis Set|||events|||Number
2828216|NCT00316602|Secondary|Number of Participants With Solicited General AEs|Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Safety Analysis Set|||Participants|||Count of Participants
2828217|NCT00316602|Secondary|Number of Participants With Solicited Local Adverse Events|Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Safety Analysis Set|||Participants|||Count of Participants
2828218|NCT00316602|Secondary|Number of Participants With Related Grade >=3 Adverse Events|Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.|within 29 days after vaccination|Safety Analysis Set|||Participants|||Count of Participants
2828219|NCT00316602|Secondary|Number of Participants With SAEs|Occurrence, relationship and intensity of any serious AE (SAE)|within 32 weeks|Safety Analysis Set|||Participants|||Count of Participants
2828220|NCT00316602|Secondary|ELISPOT IFN-γ Values|Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay|within 6 weeks|ELISPOT Analysis Set|||Spot Forming Units / 10^6 PBMC||Full Range|Median
2828221|NCT00316602|Secondary|PRNT GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.|within 32 weeks|Per Protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2828222|NCT00316602|Secondary|Percentage of Participants With Seroconversion by PRNT|Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 32 weeks|Per Protocol Set|||percentage of subjects||95% Confidence Interval|Number
2828223|NCT00316602|Secondary|ELISA GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.|within 32 weeks|Per Protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2828224|NCT00316602|Secondary|Percentage of Participants With Seroconversion by ELISA|Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 32 weeks|Per Protocol Set|||percentage of subjects||95% Confidence Interval|Number
2828225|NCT00316602|Primary|Percentage of Participants With Seroconversion by ELISA|Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|week 6|Per Protocol Set|||percentage of subjects||95% Confidence Interval|Number
2828226|NCT00316589|Secondary|ELISPOT IFN-γ: SFU|Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.|within 32 weeks|Elispot Analysis Set (subset of the Per-protocol Set with ELISPOT data available)|||Spot Forming Units / 10^6 PBMC||Full Range|Median
2828227|NCT00316589|Secondary|ELISPOT IFN-γ: Response Rate|Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.|within 32 weeks|Elispot Analysis Set (subset of the Per-protocol Set with ELISPOT data available)|||percentage of subjects||95% Confidence Interval|Number
2828228|NCT00316589|Secondary|ELISA GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.|within 32 weeks|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2828229|NCT00316589|Secondary|ELISA Seroconversion Rate|Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 32 weeks|Per-protocol set|||percentage of subjects||95% Confidence Interval|Number
2828230|NCT00316589|Secondary|PRNT GMT|Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.|within 32 weeks|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2828475|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data|||RMDQ Scale||Inter-Quartile Range|Median
2828231|NCT00316589|Secondary|PRNT Seroconversion Rate|Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 32 weeks|Per-protocol set|||percentage of subjects||95% Confidence Interval|Number
2828232|NCT00316589|Secondary|Viral Load|Viral load (HIV-1 RNA levels) over time|within 32 weeks|Full Analysis Set (HIV infected subjects)|||Participants|||Count of Participants
2828233|NCT00316589|Secondary|CD8+ T-cell Counts|Median CD8+ T-cell counts over time|within 32 weeks|Full Analysis Set (HIV infected subjects)|||CD8 count (cells/µL)||Full Range|Median
2828234|NCT00316589|Secondary|CD4+ T-cell Counts|Median CD4+ T-cell counts over time|within 32 weeks|Full Analysis Set (HIV infected subjects)|||CD4 count (cells/µL)||Full Range|Median
2828235|NCT00316589|Secondary|Unsolicited Adverse Events: Relationship to Vaccination|Occurrence of unsolicited adverse events by relationship to study vaccine|within 29 days after any vaccination|Full Analysis Set|||events|||Number
2828236|NCT00316589|Secondary|Unsolicited Adverse Events: Intensity|Occurrence of unsolicited adverse events by Intensity|within 29 days after any vaccination|Full Analysis Set|||events|||Number
2828237|NCT00316589|Secondary|Unsolicited Adverse Events: Incidence|Incidence of any unsolicited adverse events|within 29 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2828238|NCT00316589|Secondary|Solicited General Adverse Events|Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2828239|NCT00316589|Secondary|Solicited Local Adverse Events|Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2828240|NCT00316589|Secondary|Related Grade >=3 Adverse Events|Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine|within 29 days after any vaccination|Full Analysis set|||Participants|||Count of Participants
2828241|NCT00316589|Primary|Serious Adverse Events|Incidence, relationship and intensity of any Serious Adverse Event (SAE)|within 32 weeks|Full Analysis Set|||Participants|||Count of Participants
2828242|NCT00316524|Secondary|Number of Participants With Unsolicited Non-serious Adverse Events|Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0).|within 4 weeks after any vaccination|Safety dataset|||Participants|||Count of Participants
2828243|NCT00316524|Secondary|Number of Participants With Related Grade>=3 Adverse Events|Number of participants with any Grade >=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs.|within 4 weeks after any vaccination|Safety dataset|||Participants|||Count of Participants
2828244|NCT00316524|Secondary|Number of Participants With Solicited General Adverse Events|Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Safety dataset|||Participants|||Count of Participants
2828245|NCT00316524|Secondary|Number of Participants With Solicited Local Adverse Events|Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.|within 8 days after any vaccination|Safety dataset|||Participants|||Count of Participants
2828246|NCT00316524|Secondary|Number of Participants With Related Serious Adverse Events|Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study|within 32 weeks|Safety dataset|||Participants|||Count of Participants
2828247|NCT00316524|Secondary|Percentage of Participants With Seroconversion by PRNT|Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)|Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination)|||percentage of subjects|||Number
2828248|NCT00316524|Secondary|Percentage of Participants With Seroconversion by PRNT|Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)|Full Analysis Set|||percentage of subjects|||Number
2828249|NCT00316524|Secondary|Percentage of Participants With Seroconversion by ELISA|Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)|Full Analysis Set (includes subjects with data available 4 weeks following the last vaccination)|||percentage of subjects|||Number
2828250|NCT00316524|Primary|Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI])|Occurrence and relationship of any other cardiac symptom at any time during the study|within 32 weeks|Safety dataset|||events|||Number
2828252|NCT00316524|Primary|Percentage of Participants With Seroconversion by ELISA|Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)|Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2828253|NCT00316355|Primary|Treatment-related Total Cost Estimates|total estimated costs calculated based upon the fixed-dose schedule|Posttreatment|Treatment completers|||dollars||Standard Deviation|Mean
2828254|NCT00316355|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score|The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.|Pretreatment, Posttreatment, and 3-month follow-up|Randomized participants|||units on a scale||Standard Deviation|Mean
2828255|NCT00316303|Primary|Referral for Medical Care|For participants infected with hepatitis C, their self-report of being referred for medical care.|6 Months||||participants|||Number
2828256|NCT00316303|Primary|Tested for HIV|Participant self-report of being tested for HIV|6 Months||||participants|||Number
2828257|NCT00316303|Primary|Tested for Hepatitis B|Participant self-report of being tested for hepatitis B|6 Months||||participants|||Number
2828258|NCT00316303|Primary|Tested for Hepatitis C|Participant self-report of being tested for hepatitis C|6 Months||||participants|||Number
2828259|NCT00316303|Primary|Change in Immunization Status|Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.|Measured at 6 Months relative to Baseline||||participants|||Number
2828260|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment|In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.|12 weeks in Phase 2 period (i.e., 24 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.|||participants|||Number
2828261|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks||||participants|||Number
2828262|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks|Participants randomized to Phase 1 were stratified by two variables: current chronic pain and lifetime heroin use.|||participants|||Number
2828263|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks||||participants|||Number
2828264|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks|379 identified as having chronic pain at baseline in Phase 1.|||participants|||Number
2828265|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up|A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks.|24 weeks in Phase 2 period (i.e., 36 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.|||participants|||Number
2828266|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1|In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.|12 weeks|653 study participants randomized to Phase 1 were included in analysis.|||participants|||Number
2828267|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Any Time|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828268|NCT00316264|Secondary|The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final pose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828282|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828269|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 150|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828270|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 60|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828271|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 0|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828272|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Any Time|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828273|NCT00316264|Secondary|The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828274|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 150|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828275|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 60|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828276|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 0|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||participants with detected antibody|||Number
2828277|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828278|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828279|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828280|NCT00316264|Secondary|The Serum Concentrations of Palivizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828281|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828283|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828284|NCT00316264|Secondary|The Serum Concentrations of Motavizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.|||μg/mL||Standard Deviation|Mean
2828285|NCT00316264|Primary|Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.|Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.|Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.|||participants|||Number
2828286|NCT00316264|Primary|Number of Subjects Reporting Adverse Events (AEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.|||participants|||Number
2828287|NCT00316264|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.|||participants|||Number
2828288|NCT00316225|Primary|Overview of Adverse Events|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
2828289|NCT00316225|Secondary|Discontinuations Due to Adverse Events|Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
2828290|NCT00316225|Other Pre-specified|Overall Tumor Response|"Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments.~CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions.~PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions.~SD (stable disease) = small changes that do not meet above criteria."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
2828291|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics: Volume of Distribution|Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.|||Liters (L)||Standard Deviation|Mean
2828292|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics (PK): Clearance|Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.|||milliliter per minute (mL/min)||Standard Deviation|Mean
2828293|NCT00316225|Secondary|Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities|"Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening.~NOS = Not otherwise specified."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.|||participants|||Number
2828294|NCT00316199|Secondary|Overall Survival Probability|Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.|baseline to date of death from any cause|All enrolled participants. Fifty-two participants were censored.|||percent|||Number
2828295|NCT00316199|Secondary|Duration of Response|Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.|time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|Enrolled participants who were considered responders (had either a complete response or partial response).|||months||95% Confidence Interval|Median
2828318|NCT00316082|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2828296|NCT00316199|Secondary|Progression-Free Survival|Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.|baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants. Forty-two participants were censored.|||months||95% Confidence Interval|Median
2828297|NCT00316199|Secondary|Time to Treatment Failure|Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.|baseline to stopping treatment|All enrolled participants. Time to treatment failure for participants who are still participating in the study without treatment failure at the time of analysis will be treated as censored at thte date of the last tumor assessment (3 participants censored).|||months||95% Confidence Interval|Median
2828298|NCT00316199|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants diagnosed with metastatic breast cancer, had measurable disease at baseline, and received at least one dose of study drug. Two participants were excluded from analysis because they received chemotherapy for locally advanced/metastatic breast cancer within 6 months prior to enrollment.|||participants|||Number
2828299|NCT00316186|Secondary|Grade 4 (Life-threatening or Disabling) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)|||participants|||Number
2828300|NCT00316186|Secondary|Grade 3 (Severe) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)|||participants|||Number
2828301|NCT00316186|Secondary|Grade 2 (Moderate) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT Population (i.e., participants who had at least one dose of study medication)|||participants|||Number
2828302|NCT00316186|Secondary|Grade 1 (Mild) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity)|ITT Population (i.e., participants who had at least one dose of study medication)|||participants|||Number
2828303|NCT00316186|Secondary|Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up|Overall survival is defined as the time from the start of treatment until death due to any cause. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage of the study was not conducted.|Week 1 up to maximum of Day 519|||||||
2828304|NCT00316186|Secondary|Time to Progression|Time to progression is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From start of treatment to disease progression/death|||||||
2828305|NCT00316186|Secondary|Response Duration|Duration of response is calculated as the time from first documented partial or complete response until first documented sign of disease progression or death. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From time of partial or complete response to disease progression/death|||||||
2828306|NCT00316186|Secondary|Time to Response|Time to response is calculated as the time from the start of treatment until first documented evidence of partial or complete response. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage was not done.|From start of treatment to evidence of partial or complete response|||||||
2828319|NCT00316082|Secondary|Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||percent||Standard Error|Mean
2828307|NCT00316186|Primary|Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response|The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.|Baseline until up to Day 169|ITT (Intent to Treat): participants that received at least one dose of study drug|||Participants|||Number
2828308|NCT00316173|Secondary|Time to Disease Progression|"Although Time to Disease Progression was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of Progression-free Survival. As such, Progression-free Survival was measured, not Time to Disease Progression. See the outcome measure entitled Progression-free Survival for data pertaining to time to disease progression."|From start of treatment to disease progression/death|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||||||
2828309|NCT00316173|Secondary|The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)|"CA-125 is a tumor marker, found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline."|Baseline to end of study (up to 54.7 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||participants|||Number
2828310|NCT00316173|Secondary|Number of Participants Who Died From the Start of Treatment to Follow-up|"The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was censored."|From start of treatment to death (up to 110.4 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||participants|||Number
2828311|NCT00316173|Secondary|Progression-free Survival|"Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Although Time to Disease Progression was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of PFS. As such, PFS was measured, not Time to Disease Progression."|From start of treatment to disease progression/death (up to 67.7 weeks)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||weeks||95% Confidence Interval|Median
2828312|NCT00316173|Primary|Number of Participants With the Indicated Response|Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).|From start of treatment to evidence of CR or PR (up to 39.3 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||participants|||Number
2828313|NCT00316173|Secondary|Duration of Response|"Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored."|From time of PR or CR to disease progression/death (up to 56.0 weeks)|All participants who showed a tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
2828314|NCT00316173|Secondary|Time to Response|Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; >50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).|From start of treatment to evidence of PR or CR (up to 39.3 weeks)|All participants who showed a tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
2828315|NCT00316121|Primary|Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)|Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).|24 months|Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset.|||Subjects|||Number
2828316|NCT00316082|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
2828317|NCT00316082|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
2828320|NCT00316082|Primary|Change From Baseline in Hemoglobin A1 (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.|||percent||Standard Error|Mean
2828321|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days||||participants|||Number
2828322|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital||||participants|||Number
2828323|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died in Field or ED|This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received 911 call to the time of death in the field or ED||||participants|||Number
2828324|NCT00316017|Secondary|Greater Than 10 Units PRBC in First 24 Hours|This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours||||participants|||Number
2828325|NCT00316017|Secondary|1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days||||participants|||Number
2828326|NCT00316017|Secondary|1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital||||participants|||Number
2828327|NCT00316017|Secondary|1-9 Units PRBC and Died in Field or ED|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.|From the time dispatch received 911 call to the time of death in the field or ED||||participants|||Number
2828328|NCT00316017|Secondary|1-9 Units PRBC in First 24 Hours|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours||||participants|||Number
2828329|NCT00316017|Secondary|Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.|From the time dispatch received the 911 call to 28 days||||participants|||Number
2828330|NCT00316017|Secondary|Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.|The first 6 hours from the time of admission to the hospital||||participants|||Number
2828331|NCT00316017|Secondary|Zero Units PRBC and Died in Field or Emergency Department (ED)|This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.|From the time dispatch received 911 call to the time of death in the field or ED||||participants|||Number
2828332|NCT00316017|Secondary|Zero Units PRBC in First 24 Hours|This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours||||participants|||Number
2828333|NCT00316017|Secondary|Survival at Hospital Discharge|Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.|Duration of hospital stay through to discharge||||participants|||Number
2828334|NCT00316017|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|First 28 days from the time of 911 call||||days||Standard Deviation|Mean
2828335|NCT00316017|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|First 28 days from the time of 911 call||||days||Standard Deviation|Mean
2828336|NCT00316017|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day O through day 28 that the patient did not require mechanical ventilation"|Duration of hospital stay through day 28||||days||Standard Deviation|Mean
2828337|NCT00316017|Secondary|Total Fluids First 24 Hours|The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call|First 24 hours from the time of of 911 call||||Liters||Standard Deviation|Mean
2828338|NCT00316017|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The numbers of units of packed red blood cells transfused in the first 24 hours|First 24 hours from the time of 911 call||||units of packed red blood cells||Standard Deviation|Mean
2828339|NCT00316017|Secondary|Presence of Nosocomial Infection Through Day 28|Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection|Within 28 days of injury, while hospitalized||||participants|||Number
2828340|NCT00316017|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28|"Multiple Organ Dysfunction Score is described as:~Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score."|28 days from time of ED arrival||||Scores on a scale||Standard Deviation|Mean
2828342|NCT00316017|Primary|28 Day Survival|"The day of episode is counted as Day 0. So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28)."|28 days from time of Emergency Department (ED) arrival|Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.|||participants|||Number
2828343|NCT00316004|Secondary|Discharge Disposition|Disposition of patient at the time of discharge from the acute care hospital|Duration of hospital stay|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Participants|||Number
2828344|NCT00316004|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.|||Unit of PRBC||Standard Deviation|Mean
2828345|NCT00316004|Secondary|Total Fluids in First 24 Hours|The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.|||Liters||Standard Deviation|Mean
2828346|NCT00316004|Secondary|Presence of Nosocomial Infections|Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection|From day of injury to 28 days after injury|"An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. Percentages were based on population at risk.~Row 1 nosocomial infections; Row 2 pneumonia; Row 3 bloodstream infections; Row 4 urinary tract infections; and Row 5 wound infections"|||Diagnoses|||Number
2828347|NCT00316004|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Days||Standard Deviation|Mean
2828348|NCT00316004|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Days||Standard Deviation|Mean
2828349|NCT00316004|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day 0 through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Days||Standard Deviation|Mean
2828350|NCT00316004|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Through Day 28|Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Scores on a scale||Standard Deviation|Mean
2828351|NCT00316004|Secondary|Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28|The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.|||Participants|||Number
2828352|NCT00316004|Secondary|Survival at Hospital Discharge up to 6 Months From Date of Injury|The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.|Date of hospital discharge up to 6 months from date of injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.|||Participants|||Number
2828353|NCT00316004|Secondary|28 Day Survival|The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.|28 days after injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who did not refuse or were lost to follow-up prior to discharge.|||Participants|||Number
2828476|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data|||RMDQ Scale||Inter-Quartile Range|Median
2828354|NCT00316004|Secondary|Disability Rating Score (DRS) Categories of Disability|The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
2828355|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
2828356|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
2828357|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|||Participants (with imputed values)|||Number
2828358|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis|Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.|6 months after injury|The primary analysis was designed as modified intent-to-treat, with all patients who had fluid connected to intravenous (IV) tubing included regardless of how much fluid was administered. Per the a priori trial design, patients for whom the fluid bag was opened but not connected to the IV were not considered enrolled in the trial.|||Participants|||Number
2828359|NCT00315939|Primary|Frequency of Severe Hypoglycemia|"Severe hypoglycemia (SH) was defined to subjects as blood glucose so low that you could not treat yourself because you were stuporous or unconscious."|1 year (each level lasted 3 months)|"All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using dropout as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown."|||episodes/month/person|||Number
2828360|NCT00315939|Primary|Hemoglobin A1c||1 year (each level lasted 3 months)|All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using “dropout” as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2828361|NCT00315822|Primary|Proportion of Patients With Collapsed Composite Complications|Proportion of patients with the collapsed composite complications, including surgical wound infection, anastomotic leak, intra-abdominal abscess, peritonitis without leak, sepsis, wound dehiscence, intestinal obstruction, bleeding, and death during 60 days after surgery|60 days after surgery||||Participants|||Count of Participants
2828362|NCT00315731|Secondary|Overall Survival|Time to death is defined as the time from the dosimetric dose to the date of death.|Week 7 to Week 260 post treatment|ITT-E Population|||months||95% Confidence Interval|Median
2828363|NCT00315731|Secondary|Progression-free Survival|Progression-free survival, or time to progression, is defined as the time from the dosimetric dose to the first documented disease progression (PD) or death. PD is defined as a >= 50% increase from nadir in the SPPD for all measurable disease.|Week 7 to Week 260 post treatment|ITT-E Population|||months||95% Confidence Interval|Median
2828365|NCT00315731|Secondary|Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)|Evaluation based on the Int'l Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma (NHL). CR, complete disappearance of all detectable clinical/radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to NHL. CRu, complete response unconfirmed, included complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. PR, >=50% decrease in sum of perpendicular diameters (SPD) of all measurable lesions determined at baseline. SD, less than a PR but not progressive disease (>=50% increase from nadir in SPD for all measurable disease or the appearance of any new lesion that was >=1.4 cm x 1.4 cm by radiographic evaluation or >=1.0 cm by palpation per physical examination).|From Baseline up to 99 Months|ITT-E Population. The individual categories for confirmed CR, confirmed CRu, etc. counts those participants who had their response confirmed by the exact same response, not those who had their response confirmed by a better response (for example, Cru to CR; PR to CR; PR to CRU; etc.).|||percentage of participants|||Number
2828366|NCT00315731|Secondary|Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.|Expected biodistribution (images): most radioactivity (RA) in blood pool, with uptake in normal liver and spleen less than the heart. Later time points, RA in blood pool decrease and uptake in normal liver and spleen decrease. Images may show uptake by the thyroid gland, kidneys, urinary bladder, and lungs. Altered biodistribution: Blood pool not visualized or diffuse, intense uptake in the liver and/or spleen, or uptake suggestive of urinary obstruction, diffuse lung uptake greater than the blood pool|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points.|||participants|||Number
2828367|NCT00315731|Secondary|Mean Absorbed Dose in the Source Organs and the Target Organs|The radiation absorbed dose to source organs were determined with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software using residence times directly determined by an independent reviewer for kidneys, liver, lungs, spleen, urinary bladder, and total body; the radiation absorbed dose for the remaining target organs was based on a mathematical model used to calculate source organ radiation dose estimates using the same OLINDA/EXM software. OLINDA/EXM is a registered proprietary computer program.|0 to 7 days from dosimetric dose|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).|||mGy/MBq||95% Confidence Interval|Mean
2828368|NCT00315731|Secondary|Mean Residence Times From Day 0 to Day 7|Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. Assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the total body residence times. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).|||hours||95% Confidence Interval|Mean
2828369|NCT00315731|Secondary|Maximum Concentration (Cmax) Values|Maximum observed concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after the dose.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID/mL||95% Confidence Interval|Geometric Mean
2828370|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)|Ratio and 90% CI for AUC (0 to infinity) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose is given.|0 to infinity h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
2828371|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 168 Hours|Ratio and 90% confidence interval for AUC(0-168) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium-derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose.|0-168 h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
2828372|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours|Area under the concentration-time curve from time 0 to 120 hours after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
2828373|NCT00315731|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||milliliters (ml)||95% Confidence Interval|Geometric Mean
2828374|NCT00315731|Primary|Clearance (CL) Values|Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||milliliters per hour (ml/hr)||95% Confidence Interval|Geometric Mean
2828375|NCT00315731|Primary|Terminal Phase Half-life (t½)|The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||hours||95% Confidence Interval|Geometric Mean
2828376|NCT00315731|Primary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID/mL||95% Confidence Interval|Geometric Mean
2828377|NCT00315731|Primary|Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours|Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.|||%ID.h/mL||95% Confidence Interval|Geometric Mean
2828378|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
2828379|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 2|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase 2 portion of study)|All participants|||participants|||Number
2828380|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
2828381|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|Phase 2 participants who achieved overall remission. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
2828382|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 2|The weeks between start of intervention and remission as assessed by the investigator in Phase 2. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 2 portion of study)|Participants in phase 2 who had an overall remission.|||weeks||Standard Deviation|Mean
2828383|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 2|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 2 portion of study)|All phase 2 participants|||participants|||Number
2828384|NCT00315705|Primary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ≥75/ ≥0.75 [x 10^9/L] 2) CR in absence of plt recovery (CRp): plt ≥20 to <75 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 28-56 days (Phase 2 portion of study)|All phase 2 participants|||percentage of total participants|||Number
2828385|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants|||weeks||95% Confidence Interval|Median
2828386|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 1|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase I portion of study)|All participants|||participants|||Number
2828387|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
2828519|NCT00314353|Secondary|Duration of Response||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
2828388|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|Phase 1 participants who achieved overall remission. Data are censored at date of last known follow-up visit.|||weeks||95% Confidence Interval|Median
2828389|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 1|The weeks between start of intervention and remission as assessed by the investigator in Phase 1. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 1 portion of study)|Participants in phase 1 who had an overall remission.|||weeks||Standard Deviation|Mean
2828390|NCT00315705|Secondary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ALL ≥75/ ≥0.75 [x 10^9/L]; AML ≥100/ ≥1.0 [x 10^9/L] 2) CR in absence of plt recovery (CRp): ALL plt ≥20 to <75 x 10^9/L; AML plt ≥20 to <100 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 2 months (Phase 1 portion of study)|All phase 1 participants|||percentage of total participants|||Number
2828391|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 1|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 1 portion of study)|All phase 1 participants|||participants|||Number
2828392|NCT00315705|Primary|Participants With Dose Limiting Toxicity in Phase 1|The number of participants in each cohort that had dose limiting toxicity is summarized. Toxicities were reviewed by an independent Data Safety Monitoring Board (DSMB) who determined if additional participants should be added to the cohort and the criteria for escalating to the next cohort.|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants|||participants|||Number
2828393|NCT00315705|Primary|Maximum Tolerated Dose (MTD) in Phase 1|"The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D.~The rating scale used is 0 = not the MTD, 1 = the MTD."|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants|||units on a scale|||Number
2828394|NCT00315627|Secondary|Restoration of Hypoglycemia Awareness 1 Year After Transplantation|The number of subjects with restoration of hypoglycemia awareness 1 year after islet transplantation|1 year||||Participants|||Count of Participants
2828395|NCT00315627|Secondary|Elimination of Severe Hypoglycemia|The number of subjects with severe hypoglycemia after transplantation|1 year||||Participants|||Count of Participants
2828396|NCT00315627|Secondary|Improvement in Metabolic Control as Evidenced by Hemoglobin A1c < 6.5%|Number of subjects with a hemoglobin A1c < 6.5% at 1year after islet transplantation|1 year||||Participants|||Count of Participants
2828397|NCT00315627|Secondary|Islet Allograft Function|Number of subjects with basal C-peptide greater than 0.5 ng/ml|1 year||||Participants|||Count of Participants
2828398|NCT00315627|Primary|Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia|Number of subjects at 1 year with HbA1c < 6.5% and absence of severe hypoglycemia|1 year||||participants|||Number
2828399|NCT00315614|Secondary|Number of Subjects With Reduction of Severe Hypoglycemia and Improvement in Hypoglycemia Awareness|Number of subjects with reduction of episodes of severe hypoglycemia and the presence of awareness of hypoglycemia|for the duration of islet graft function||||Participants|||Count of Participants
2828400|NCT00315614|Secondary|Number of Subjects With Basal C-peptide Greater Than 0.5 ng/ml|Number of subjects with basal C-peptide greater than 0.5 ng/ml prior to weaning of immunosuppression;|for the duration of islet graft function||||Participants|||Count of Participants
2828401|NCT00315614|Primary|A Reduction or Absence of Rejection Episodes|Number of rejection episodes after transplantation. Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.|for the duration of islet graft function|IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.||||||
2828402|NCT00315614|Primary|The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.|Immunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint.|for the duration of islet graft function|IImmunosuppression was never discontinued. Patients elected to move to other trials to receive additional islet infusions. Since immunosuppression was never discontinued we were not able to evaluate the primary endpoint. No data available to analyze.||||||
2828403|NCT00315588|Secondary|Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness|Elimination or reduction in the incidence of hypoglycemic coma or unawareness|1 years||||Participants|||Count of Participants
2828404|NCT00315588|Secondary|Reduction of Insulin Requirements|Reduction in insulin requirements in those patients who do not achieve insulin independence|1year||||Participants|||Count of Participants
2828405|NCT00315588|Secondary|Stimulated C-peptide Greater Than 0.5 ng/ml|Partial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml|1 year||||Participants|||Count of Participants
2828407|NCT00315458|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.|483 days|The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.|||participants|||Number
2828408|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828409|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828410|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828411|NCT00315445|Post-Hoc|"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828412|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF"|"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it. Primary back pain was measured."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828413|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)"|"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it."|Baseline to days 21 - 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828414|NCT00315445|Secondary|The Time to Discontinuation Due to Lack of Efficacy|Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.|Time after dosing to dropout due to lack of efficacy|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data."|||Days||Inter-Quartile Range|Median
2828520|NCT00314353|Secondary|Overall Survival||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
2828415|NCT00315445|Secondary|Time to Stable Pain Management|"For each subject, time to stable pain management is defined as the first (post-baseline) time during the titration period when his/her diary pain was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the pain on the average (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline)."|Start of study to day 21.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Days||Inter-Quartile Range|Median
2828416|NCT00315445|Secondary|Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)|"The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = No response to 3 = Marked response."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828417|NCT00315445|Secondary|Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)|"The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = Worse than prestudy medicine to 2 = Better than prestudy medicine."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828418|NCT00315445|Secondary|Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)|"The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = No response to 3 = Marked response."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828419|NCT00315445|Secondary|Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)|"The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = No response to 3 = Marked response."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828420|NCT00315445|Secondary|"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Mental Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828421|NCT00315445|Secondary|"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Emotional Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828422|NCT00315445|Secondary|"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Social Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828423|NCT00315445|Secondary|"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Vitality is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828424|NCT00315445|Secondary|"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. General Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828436|NCT00315328|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||participants|||Number
2828425|NCT00315445|Secondary|"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Bodily Pain is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828426|NCT00315445|Primary|Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)|"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it. Pain right now is presented as the LSmean [change from baseline] (SE)."|Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Least Squares Mean
2828427|NCT00315445|Secondary|"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"|"The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. Physical Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828428|NCT00315445|Secondary|"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"|"The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. Physical Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84, or, if applicable, at early termination|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."|||Units on a scale||Standard Error|Mean
2828429|NCT00315445|Primary|Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])|"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it."|On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy.|||Units on a scale||Standard Error|Least Squares Mean
2828430|NCT00315341|Primary|Hepatic Safety|"Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:~A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study~B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN~C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN~D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study"|24 Weeks|evaluable subjects stayed in treatment for 24 weeks and gave at least 4 blood samples for liver function tests during the treatment period|||participants|||Number
2828431|NCT00315328|Secondary|Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||ETDRS letter score||Standard Deviation|Mean
2828432|NCT00315328|Secondary|Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||participants|||Number
2828433|NCT00315328|Secondary|Mean Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||ETDRS letter score||Standard Deviation|Mean
2828434|NCT00315328|Secondary|Distribution of Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks||||participants|||Number
2828435|NCT00315328|Primary|Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks||||ETDRS letter score||Standard Deviation|Mean
2828438|NCT00315328|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.|||participants|||Number
2828439|NCT00315328|Secondary|Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)|Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.|||Units on a scale||Standard Deviation|Mean
2828440|NCT00315328|Secondary|Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)|Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.|||Units on a scale||Standard Deviation|Mean
2828441|NCT00315328|Secondary|Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)|Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.|||Units on a scale||Standard Deviation|Mean
2828442|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|"Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as within one level meaning change was -1, 0, or +1."|17 or 19 weeks||||Participants|||Number
2828443|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks||||Participants|||Number
2828444|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks||||Participants|||Number
2828445|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks||||Participants|||Number
2828446|NCT00315302|Secondary|Visual Acuity Distribution in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks||||Participants|||Number
2828447|NCT00315302|Secondary|Distribution of Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||Participants|||Number
2828448|NCT00315302|Secondary|Mean Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||logMAR units||Standard Deviation|Mean
2828521|NCT00314353|Secondary|Toxicity - Adverse Events||Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
2828449|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia|||Participants|||Number
2828450|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia|||Participants|||Number
2828451|NCT00315302|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||Participants|||Number
2828452|NCT00315302|Primary|Mean Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks||||logMAR units||Standard Deviation|Mean
2828453|NCT00315302|Primary|Visual Acuity Distribution in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks||||Participants|||Number
2828454|NCT00315302|Primary|Visual Acuity Mean Score in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.|||logMAR units||Standard Deviation|Mean
2828455|NCT00315146|Secondary|Lean Body Mass||Baseline visit (pre intervention) and 4month follow up (post intervention)||||kg||95% Confidence Interval|Least Squares Mean
2828456|NCT00315146|Primary|Appendicular Non-bone Lean Mass|Change in Appendicular Non-bone Lean Mass|Baseline visit (pre intervention) and 4month follow up (post intervention)||||kg||95% Confidence Interval|Least Squares Mean
2828457|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 12)|Subjects who reported being very satisfied with back care|12 weeks||||participants||95% Confidence Interval|Number
2828458|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 8)|Subjects who reported being very satisfied with back care|8 weeks||||participants||95% Confidence Interval|Number
2828459|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 4)|Subjects who reported being very satisfied with back care|4 weeks||||participants||95% Confidence Interval|Number
2828460|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 12)|Subjects who reported being very satisfied with back care|12 weeks||||participants||95% Confidence Interval|Number
2828461|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 8)|Subjects who reported being very satisfied with back care|8 weeks||||participants||95% Confidence Interval|Number
2828462|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 4)|Subjects who reported being very satisfied with back care|4 weeks||||participants||95% Confidence Interval|Number
2828463|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
2828464|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
2828465|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
2828466|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.|||Participants who reported lost work days||95% Confidence Interval|Number
2828477|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks||||participants|||Number
2828478|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data|||RMDQ Scale||Inter-Quartile Range|Median
2828479|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data|||RMDQ Scale||Inter-Quartile Range|Median
2828480|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data|||RMDQ Scale||Inter-Quartile Range|Median
2828481|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data|||RMDQ Scale||Inter-Quartile Range|Median
2828482|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks||||participants|||Number
2828483|NCT00315055|Secondary|Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability|Day 0 to Day 7 post any dose|Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received.|||Participants|||Number
2828484|NCT00315055|Secondary|Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.|Day 90 (30 Days post-dose 3)|Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Titers||95% Confidence Interval|Geometric Mean
2828485|NCT00315055|Secondary|Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).|Day 0 (pre-vaccination) and Day 30 post-dose 3|Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
2828486|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.|Day 90 post first dose|Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
2828487|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.|Day 90 post first dose|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
2828488|NCT00315055|Primary|Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 90 post first dose|Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.|||Percentage of Participants|||Number
2828489|NCT00314951|Other Pre-specified|Global Cure|Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.|End of Study (Day 40)|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.|||Percentage of Participants|||Number
2828490|NCT00314951|Secondary|Recurrence|Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The mITT population for subjects who met the primary endpoint of cure subjects, were analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.|||Percentage of Participants|||Number
2828491|NCT00314951|Primary|Cure Rate at End of Therapy|Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2828492|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- MMSE|The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function.|baseline and 2 months|17 patients provided both a pre- and post-treatment assessment of MMSE.|||units on a scale||Standard Deviation|Mean
2828493|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FLIE|The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54.|baseline, 24 hours, and 72 hours|For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 and 72 hours.|||units on a scale||Standard Deviation|Mean
2828494|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FACT-Br|The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76.|baseline and 2 months|19 patients provided both baseline and follow-up assessments; however, only 11 patients provided adequate information to compute the score for the additional brain cancer specific concerns subscale.|||units on a scale||Standard Deviation|Mean
2828495|NCT00314808|Primary|Unacceptable Toxicity Rate|Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities|2 months|All treated patients|||percentage of participants||95% Confidence Interval|Number
2828496|NCT00314808|Primary|Tolerability Rate|Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events|Two months|25 of the 33 patients treated with Dronabinol completed 2 cycles of protocol treatment or terminated protocol treatment due to adverse events. The remaining 8 patients are excluded from this tabulation as they terminated Dronabinol treatment before completion of 2 cycles of treatment for reasons unrelated to adverse events.|||percentage of participants||95% Confidence Interval|Number
2828497|NCT00314795|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From signing of informed consent form up to Month 60|Safety analysis set included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2828498|NCT00314795|Secondary|Time to Initial Achievement of Hemoglobin (Hgb) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusions in the Previous 28 Days|The time between first dose administered and the initial achievement of a Hgb increase ≥11 g/dL for two consecutive visits was calculated for each participant as the number of days between the first dose administration date and the earlier of (1) the study termination date [i.e. censor date] and (2) the first date of an Hgb increase ≥ 11 g/dL for two consecutive visits without whole blood or RBC transfusion during the previous 28 days. Time to initial Hgb increase ≥ 11 g/dL will be calculated for each participant as the minimum of censor date and increase date minus the first dose date plus 1.|Up to 60 months|Efficacy endpoint data was not collected due to low patient enrollment and the drug was withdrawn from the market.||||||
2828499|NCT00314795|Secondary|Percentage of Participants With RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study||26 weeks prior to enrollment up to end of study (up to 60 months)|Efficacy endpoint data was not collected due to low patient enrollment and the drug was withdrawn from the market.||||||
2828500|NCT00314795|Secondary|Number of Red Blood Cells (RBCs) Transfusions During the 26 Weeks Pre-treatment Period (Prior to Enrollment) and During 13- and 26 Weeks Intervals During the Study||26 weeks prior to enrollment up to end of study (up to 60 months)|Efficacy endpoint data was not collected due to low patient enrollment and the drug was withdrawn from the market.||||||
2828501|NCT00314795|Primary|Percentage of Participants Who Experienced Increase and Maintain Hemoglobin Levels (Two Consecutive Values) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusion in the Previous 28 Days by Week 24|Percentage of participants who experienced increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit (11 g/dL) in the absence of red blood cell transfusion in the previous 28 days by week 24 were reported.|Up to Week 24|Efficacy endpoint data was not collected due to low patient enrollment and the drug was withdrawn from the market.||||||
2828502|NCT00314574|Secondary|Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events|This outcome is represented in the adverse event section of the database.|Week 48|Safety Population: The safety-evaluable population comprised 848 patients (428 Xolair group and 420 placebo group). Patients in the safety-evaluable population were analyzed according to the actual treatment received. One subject was assigned to receive placebo but inadvertently received at least one dose of xolair during the study.|||participants|||Number
2828503|NCT00314574|Secondary|Change From Baseline in Overall Asthma-related Quality of Life|Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score. The AQLQ(S) consists of 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; the overall score is the mean of these 32 items on a scale of 1 to 7 (1 = severe impairment, 7 = no impairment). Overall outcome achieved by mean visit minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.|||score on a scale||Standard Deviation|Mean
2828504|NCT00314574|Secondary|Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication|Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.|||puffs per day||Standard Deviation|Mean
2828505|NCT00314574|Secondary|Change From Baseline in Total Asthma Symptom Scores|Change from baseline to week 48 in Total Asthma Symptom Score (TASS), which included a nocturnal asthma score (0 to 4 scale), morning asthma symptoms (yes or no), and a daytime asthma symptom score (0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough. Score achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug. Ten patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.|||score on a scale||Standard Deviation|Mean
2828506|NCT00314574|Primary|Rate of Asthma Exacerbations Over the 48 Week Treatment Period|A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group.|48 weeks|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo).|||exacerbation/patient-week|||Number
2828507|NCT00314366|Secondary|Total Severity Score (Reversible)|"For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress.~Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined."|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2828522|NCT00314353|Secondary|Objective Response Rate||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
2828508|NCT00314366|Secondary|Total Severity Score (Rest)|"For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest.~Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.~Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2828509|NCT00314366|Secondary|Total Severity Score (Stress)|"For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling.~Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.~Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2828510|NCT00314366|Secondary|Echocardiography (EF) Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline and 6 months||||percentage of blood||Standard Deviation|Mean
2828511|NCT00314366|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline and 6 months|data from 9 stem cell patients at 6 months, 10 at baseline|||ml/kg/min||Standard Deviation|Mean
2828512|NCT00314366|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2828513|NCT00314366|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline and 6 months||||ml||Standard Deviation|Mean
2828514|NCT00314366|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline and 6 months||||ml||Standard Deviation|Mean
2828515|NCT00314366|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|Baseline and 6 months||||percentage of blood||Standard Deviation|Mean
2828516|NCT00314366|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).~Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2828517|NCT00314366|Secondary|New York Heart Association (NYHA) Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.~Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|Baseline and 6 months||||NYHA Functional class||Standard Deviation|Mean
2828518|NCT00314366|Primary|Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events|Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|Baseline and 6 months|The data was analyzed for all participants in control and treated groups.|||participants|||Number
2828591|NCT00313716|Secondary|Mortality Rate|mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization|up to 6 months after injury|Intention to treat analysis|||participants|||Number
2828523|NCT00314353|Primary|One-year Progression-free Survival (PFS)|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.|Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.||||||
2828524|NCT00314340|Primary|3 Scores on the Addiction Research Center Inventory (ARCI)|The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine-Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital-Chorpromazine-Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.|0, 60, 120, 180, 240, or 300 minutes|Treatment effects at baseline, 60, 120, 180, 240, and 300 min were assessed with repeated measures ANOVA. A liner mixed-effects model with inclusion of interaction terms (1) treatment and time and (2) random order visit number and time was performed.|||scores on a scale||Standard Deviation|Mean
2828525|NCT00314327|Secondary|Negative Symptoms|Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized. The negative symptoms that were going to be analyzed include: Affective Flattening, Alogia, Avolition /Apathy, and Anhedonia/Asociality|13 weeks|Zero patients were analyzed as only one subject consented to the study and dropped out of the study before they were randomized.||||||
2828526|NCT00314327|Primary|Treatment Response Based Upon BPRS and CGI Ratings||13 weeks|||||||
2828527|NCT00314262|Primary|Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.||||participants|||Number
2828528|NCT00314262|Primary|Clinical Outcome: Documented Progression|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|12 months from time of enrollment||||participants|||Number
2828529|NCT00314262|Primary|Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4|Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.|12 months from time of enrollment||||participants|||Number
2828530|NCT00314249|Secondary|Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12|"Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status.~SF-36 PCS: weighted summary of physical function using all 8 domains.~Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.~SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase, values were imputed using the Last Observation Carried Forward (LOCF) approach.|||units on scale||Standard Error|Mean
2828531|NCT00314249|Primary|Composite Pain Responder Status|"Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of very much improved or much improved."|At the end of three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).|||Pain Responder Participants|||Number
2828532|NCT00314249|Primary|Composite Syndrome Responder Status|"Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of very much improved and much improved; and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)"|At the end of the three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).|||Syndrome Responder Participants|||Number
2828533|NCT00314249|Secondary|Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.|"Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.~MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1=yes, that is true and 5=no, that is not true."|Baseline through end of week 12 (Visit TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments at the end of week 12 (Visit TX12), values were imputed using Last Observation Carried Forward (LOCF).|||units on scale||Standard Error|Mean
2828534|NCT00314249|Secondary|Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.|"Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.~PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).|||units on scale||Standard Error|Mean
2828535|NCT00314249|Secondary|Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase|"Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.~PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain)."|Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments for weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).|||units on scale||Standard Error|Mean
2828536|NCT00314236|Secondary|Frequency of Adverse Events Between Study Groups||12 months|AEs will be coded and tabulated separately by system organ class (SOC) and individual preferred terms (PTs). The number and percentage of subjects who experienced AEs will be summarized in decreasing frequency by using the medical dictionary for regulatory activities (MedDRA) dictionary.|||Percentage of participants|||Number
2828537|NCT00314236|Secondary|Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)|The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.|12 months|Secondary efficacy was evaluated based on pain, stiffness, and function, as well as the macroscopic nature of the cartilage repair. Measurements of pain, stiffness, and function were made at 3, 6, and 12 months post-treatment using the WOMAC questionnaire and SF-36v2. WORMS scoring was conducted on 12-month post-treatment MRI scans.|||Units on a scale||Standard Error|Least Squares Mean
2828538|NCT00314236|Primary|Repair Cartilage T2 Relaxation Time|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).|12 months|Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total)|||milliseconds||Standard Error|Least Squares Mean
2828539|NCT00314236|Primary|Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.|12 months|Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total)|||Percentage of lesion fill||Standard Error|Least Squares Mean
2828540|NCT00314145|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®|"Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.~Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash."|Day 0 (Pre-vaccination) up to 60 days post-first vaccination|Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).|||Participants|||Number
2828541|NCT00314145|Secondary|Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Day 60 post-first vaccination|Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).|||Participants|||Number
2828542|NCT00314145|Secondary|Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Up to Day 60 post-first vaccination|Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).|||Titers||95% Confidence Interval|Geometric Mean
2828543|NCT00314145|Primary|Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.|Up to Day 60 post-first vaccination|Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).|||Participants|||Number
2828544|NCT00314132|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo|"Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.~Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported."|Day 0 up to 30 days post-vaccination|Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).|||Participants|||Number
2828545|NCT00314132|Primary|Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo|"Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered actively solicited through Day 30."|Day 0 up to 30 days post-vaccination|Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).|||Participants|||Number
2828546|NCT00314106|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|33 months||||Participants|||Number
2828547|NCT00314106|Primary|Complete Response|"Determine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy.~Complete response (CR) is a disappearance of all target lesions."|33 months||||Participants|||Number
2828548|NCT00314093|Secondary|Toxicity Profile|Secondary objectives will determine whether changes occur in levels of CD4+CD25+ regulatory T cells (Treg cells) in peripheral blood from before to after treatment and evaluate the toxicity profile of patients treated on this trial.||Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed||||||
2828549|NCT00314093|Secondary|Determine Whether Changes Occur in Levels of CD4+CD25+ Regulatory T Cells (Treg Cells) in Peripheral Blood|Secondary objectives will determine whether changes occur in levels of CD4+CD25+ regulatory T cells (Treg cells) in peripheral blood from before to after treatment and evaluate the toxicity profile of patients treated on this trial.|Before to after treatment|Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed||||||
2828550|NCT00314093|Primary|Clinical Responses Can be Obtained in Following Administration of RFT5-dgA|The primary objective is to determine whether objective clinical responses can be obtained in patients with metastatic melanoma following administration of RFT5-dgA|up to one year|Sincere efforts were made to obtain the study data, but were unsuccessful as all study records have been destroyed||||||
2828551|NCT00313911|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable."|Day 0 up to Day 7 Post-injection|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.|||Participants|||Number
2828552|NCT00313911|Secondary|Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|"Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.~Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively."|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
2828553|NCT00313911|Secondary|Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.|||Titers||95% Confidence Interval|Geometric Mean
2828554|NCT00313911|Primary|Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.|High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.|Day 0 up to Day 7 post-injection|The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.|||Participants|||Number
2828555|NCT00313846|Secondary|"Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site"|"The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. Pain right now scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine)."|7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.|Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.|||units on a scale||Standard Error|Mean
2828556|NCT00313846|Primary|The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.|"Inadequate analgesia:~average pain over the last 24 hours score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;~>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;~ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia."|"Double-blind phase ( 28 days): reaching inadequate analgesia on any 2 days of the 7-day dosing periods"|The Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.|||days||Standard Error|Mean
2828557|NCT00313820|Secondary|QANeP - Pain Rating Scales|Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).|Baseline, Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 [LOCF].|||scores on scale||Standard Deviation|Mean
2828558|NCT00313820|Secondary|Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold|"QANeP: assessment of sensory threshold: subject responds yes when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline)."|Baseline, Week 12|ITT; Week 12 [LOCF].|||scores on scale||Standard Deviation|Mean
2828559|NCT00313820|Secondary|Clinical Global Impression of Change (CGIC)|CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
2828560|NCT00313820|Secondary|Patient Global Impression of Change (PGIC)|PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
2828561|NCT00313820|Secondary|EQ-5D - VAS|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
2828562|NCT00313820|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Week 12|ITT|||scores on scale||Standard Error|Least Squares Mean
2828563|NCT00313820|Secondary|Hospital Anxiety and Depression Scale (HADS) - ITT Population|HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Week 12|ITT; Week 12 [LOCF]|||scores on scale||Standard Error|Least Squares Mean
2828564|NCT00313820|Secondary|Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 12|ITT|||participants|||Number
2828565|NCT00313820|Secondary|Medical Outcome Study (MOS) Sleep Scale|MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2828592|NCT00313716|Secondary|Disability Rating Scale|Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status.|at 6 months|Intention to treat analysis|||units on a scale||Inter-Quartile Range|Median
2828566|NCT00313820|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.|Week 12|ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).|||scores on scale||Standard Error|Least Squares Mean
2828567|NCT00313820|Secondary|Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only|SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Week 12|ITT|||millimeters||Standard Error|Least Squares Mean
2828568|NCT00313820|Secondary|Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])|DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.|||scores on scale||Standard Error|Least Squares Mean
2828569|NCT00313820|Secondary|Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint|50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET|||participants|||Number
2828570|NCT00313820|Secondary|Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint|30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET|||participants|||Number
2828571|NCT00313820|Secondary|Pain Score as Measured by DPRS|Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 [ET]|||scores on scale||Standard Error|Least Squares Mean
2828572|NCT00313820|Primary|Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)|Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Up to Week 12|Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET|||scores on scale||Standard Error|Least Squares Mean
2828573|NCT00313781|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
2828574|NCT00313781|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
2828575|NCT00313781|Secondary|Maximum Observed Plasma Concentration (Cmax) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
2828576|NCT00313781|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871|Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.||||||
2828577|NCT00313781|Secondary|Pain Measured by the Modified Brief Pain Inventory‑Short Form (mBPI‑sf Modified Pfizer)|"The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block."|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.||||||
2828746|NCT00311623|Secondary|PTEN Loss as Measured by Immunohistochemistry (IHC)|Determine the relationship of PD target inhibition of S6 kinase activity with pretreatment PTEN loss by IHC in prostate cancer.|Change from baseline to 15 days post-intervention|Data was not collected for this outcome measure||||||
2828578|NCT00313781|Secondary|Quality of Life Measured by the Functional Assessment of Cancer Treatment‑Prostate (FACT‑P)|The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.||||||
2828579|NCT00313781|Secondary|Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs|Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.|||Number of IGF-1R positive CTCs/7.5 mL||Standard Deviation|Mean
2828580|NCT00313781|Secondary|Total Number of Circulation Tumor Cells (CTCs)|Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.|||Number of CTCs/7.5 mL||Standard Deviation|Mean
2828581|NCT00313781|Secondary|Population PK Parameters of CP-751,871|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|||||||
2828582|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at the Last Follow-up Visit|Levels of HAHA in serum were detected at the last follow-up visit.|The last follow-up visit (150 days post last dose)|All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.|||mg/dl||Standard Deviation|Mean
2828583|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)|Levels of HAHA in serum were detected at baseline.|Baseline (Day 1 of Cycle 1)|All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.|||mg/deciliter (dl)||Standard Deviation|Mean
2828584|NCT00313781|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.|Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)|Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.|||Months||95% Confidence Interval|Median
2828585|NCT00313781|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Best Response|Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.|Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)|Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.|||Percentage of participants||90% Confidence Interval|Mean
2828586|NCT00313729|Secondary|Safety Profile|Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0|Time from registration up to 13 months||||Participants|||Count of Participants
2828587|NCT00313729|Secondary|Time to Tumor Progression|Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.|time from registration until date of the first documented progression, an average of 1 year||||years||95% Confidence Interval|Median
2828588|NCT00313729|Primary|Response Rate (Complete and Partial Response)|"Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was definitely better than prior scan with stable or improved neuro exam and steroids."|12 months||||Participants|||Count of Participants
2828589|NCT00313716|Secondary|Incidence of Infection|occurrence of infection was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis|||participants|||Number
2828590|NCT00313716|Secondary|Incidence of Adult Respiratory Distress Syndrome (ARDS)|development of ARDS was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis|||participants|||Number
2828593|NCT00313716|Primary|Glasgow Outcome Scale|Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead)|at 6 months after injury|Intention to treat. Multiple imputation for missing 6-month GOS data was performed assuming data were missing at random using chained equations (R, R Foundation for Statistical Computing).The imputation was based on a logistic regression model with baseline covariates. Results were aggregated over 20 imputed sets using variance formula by Rubin.|||participants|||Number
2828594|NCT00313703|Other Pre-specified|Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal|Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.|3 months|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.|||participants|||Number
2828595|NCT00313703|Primary|Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge|Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain|24 hours after Emergency Department (ED) discharge|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.|||Participants|||Number
2828596|NCT00313612|Secondary|Time to Disease Progression by RECIST and/or CA 125|Time to disease progression by RECIST and/or CA 125|Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks||||months||95% Confidence Interval|Median
2828597|NCT00313612|Primary|Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)|Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.|Every two cycles for up to 24 weeks.|30 patients were analyzed. Eight patients discontinued treatment before 2 cycles.|||participants|||Number
2828598|NCT00313586|Primary|Proportion of Patients With Clinical Response|"Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria:~World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett)~Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.)~Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)"|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.|All treated patients are included in the analysis.|||Proportion of patients||95% Confidence Interval|Number
2828599|NCT00313560|Secondary|Time to Death|Time of overall survival.|every 2 years post-intervention, up to 12 years||2019-11-30|11/2019||||
2828600|NCT00313560|Secondary|QoL as Assessed by QLQ-PAN 26|Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline [BL]), between completion of CRT and starting maintenance chemotherapy (time 1 [t1]), and within 3 months after completion of maintenance chemotherapy (time 2 [t2]).|3 years||2019-11-30|11/2019||||
2828601|NCT00313560|Secondary|Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)|Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline [BL]), between completion of CRT and starting maintenance chemotherapy (time 1 [t1]), and within 3 months after completion of maintenance chemotherapy (time 2 [t2]).|3 years||2019-11-30|11/2019||||
2828602|NCT00313560|Secondary|Toxicity Profile of Adjuvant Therapy|Toxicity was assessed weekly during chemoradiation and during every cycle of adjuvant chemotherapy by use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version4.0|weekly during chemoradiation and during every cycle of adjuvant chemotherapy, up to 3 years||2019-11-30|11/2019||||
2828603|NCT00313560|Primary|Recurrence Free Survival|Time from surgery to recurrence|Up to 3 years||||months||95% Confidence Interval|Median
2828604|NCT00313443|Secondary|Presence of Any Adverse Effect Attributable to Amiodarone.|Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)|Cumulated time on amiodarone (varies in each patient)||||Patients|||Number
2828605|NCT00313443|Secondary|Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations|Number of patients having complications (if any) caused by fat tissue needle aspirations|24 hours after needle aspiration||||Patients|||Number
2828606|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.|Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.|Cumulated time on amiodarone (varies in each patient)||||Logistic regression OR|||Number
2828607|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.|Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.|One single measure, taken just before daily administration||||Correlation coefficient R|||Number
2828608|NCT00313443|Primary|Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.|Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.|One single measure||||Correlation coefficient R|||Number
2828609|NCT00313313|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
2828630|NCT00313170|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks.|The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.|Full analysis set|||Percentage of patients||95% Confidence Interval|Number
2828610|NCT00313313|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
2828611|NCT00313313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2828612|NCT00313313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.|||percent||Standard Error|Mean
2828613|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.|||percentage of participants||95% Confidence Interval|Number
2828614|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization up to high dose termination, 1-Oct-2007|Participants who were concomitantly randomized in Phase B were summarized.|||participants|||Number
2828615|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.|||percentage of participants||95% Confidence Interval|Number
2828616|NCT00313300|Secondary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B|Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.|||percentage of participants||95% Confidence Interval|Number
2828617|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization and ends on high dose termination date, 1-Oct-2007|Participants who were concomitantly randomized in Phase B only were summarized (start of Phase B, March 2007, to termination of high doses in Phase B, October 2007) .|||participants|||Number
2828618|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).|from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban were analyzed.|||percentage of participants||95% Confidence Interval|Number
2828619|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B|Day of randomization to 182 days after day of randomization (183 days)|Randomized participants were summarized.|||participants|||Number
2828669|NCT00312884|Primary|Days Alive and Outside of Hospital|Days alive and outside of hospital (i.e. not admitted)|From date of randomisation for 180 days||||Days||Inter-Quartile Range|Median
2828620|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.|first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban are summarized. The analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.|||percentage of participants||95% Confidence Interval|Number
2828621|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.|Randomization to 182 days after randomization (183 days)|Participants who randomized to placebo or low dose apixaban are summarized. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.|||participants|||Number
2828622|NCT00313300|Primary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.|From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the primary analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.|||percentage of participants||95% Confidence Interval|Number
2828623|NCT00313209|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
2828624|NCT00313209|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
2828625|NCT00313209|Secondary|COPD Exacerbation Rate (Mild, Moderate or Severe)|Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [ATS / ERS 2005].|24 weeks treatment period|ITT analysis|||exacerbations per patient per year||95% Confidence Interval|Mean
2828626|NCT00313209|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2828627|NCT00313209|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2828628|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report.|Baseline to 12 weeks||||Liters||Standard Error|Least Squares Mean
2828629|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean.|Baseline to 12 weeks|Participants who had PK samples only|||litres per hour||Standard Error|Least Squares Mean
2828631|NCT00313170|Secondary|Duration of Response (DoR)|DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause.|The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.|All objective responders|||Days||Inter-Quartile Range|Median
2828632|NCT00313170|Secondary|Time to Progression (TTP)|Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression.|The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.|Full analysis set|||Days||Inter-Quartile Range|Median
2828633|NCT00313170|Primary|Objective Response (ORR)|Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).|The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.|Full analysis set|||Percentage of patients||95% Confidence Interval|Number
2828634|NCT00313144|Secondary|ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening|"All IgG and IgM titers at screening were ≤ 4. A 2-dilution step increase was defined as follows:~The titer at each 6-month visit must be ≥ 4 when the screening titer = 0~Each 6-month visit titer / screening titer should be ≥ 4. 6 month window periods are: baseline to ≤6 months, >6 months to ≤12 months, >12 months to ≤18 months, and >18 months to ≤24 months"|Baseline to 24 Months|Subjects who participated in the blood draws with data available during each window period|||Participants|||Number
2828635|NCT00313144|Secondary|Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin) and renal (Blood urea nitrogen (BUN), creatinine) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period|||mg/dL||Full Range|Median
2828636|NCT00313144|Secondary|Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period|||U/L||Full Range|Median
2828637|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses'|Number of steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Steroid Pulse Courses||Standard Deviation|Mean
2828638|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses'|Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Participants|||Number
2828639|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses'|Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Antibiotic courses||Standard Deviation|Mean
2828640|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics'|Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||Participants|||Number
2828641|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital'|Mean LOS during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Participants with data available during each window period|||Days||Standard Deviation|Mean
2828642|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations'|Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period|||Participants|||Number
2828643|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits'|Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period|||ER visits per time period||Standard Deviation|Mean
2828644|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits'|Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period|||Participants|||Number
2828684|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828645|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months|SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 24 months|Participants with baseline and participating during the period from baseline to ≤24 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828646|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤18 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828647|NCT00313144|Primary|HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤12 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828648|NCT00313144|Primary|HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828649|NCT00313144|Primary|HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828650|NCT00313144|Primary|HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828651|NCT00313144|Primary|HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828652|NCT00313144|Primary|HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828653|NCT00313144|Primary|HRQoL 'Vitality (VT)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2829006|NCT00310050|Secondary|Qualitative Dose-limiting Toxicities of Pemetrexed in Combination With Radiation Therapy|Toxicity will be determined using the revised NCI Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Number of events with grade 1-5 will be reported.|42 days|Data available for 2 participants.|||events|||Number
2828654|NCT00313144|Primary|HRQoL 'General Health (GH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828655|NCT00313144|Primary|HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828656|NCT00313144|Primary|HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828657|NCT00313144|Primary|HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL|||Scores on a scale||Standard Deviation|Mean
2828658|NCT00313014|Secondary|The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.|"The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).~Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance."|Weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Error|Mean
2828659|NCT00313014|Secondary|Oswestry Disability Index (ODI) Score (V 2.0)|"The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.~The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)"|Weeks 4, 8, 12|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Error|Mean
2828660|NCT00313014|Secondary|Mean Daily Number of Supplemental Analgesic Tablets|The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase|Double-blind phase (84 days)|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||tablets||Standard Error|Mean
2828661|NCT00313014|Primary|Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.|"Subjects were evaluated during the double-blind phase for average pain over the last 24 hours prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)"|Last 24 hours score at weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Error|Mean
2828662|NCT00312923|Secondary|Triglycerides||12 weeks||||mg/dl||Standard Deviation|Mean
2828663|NCT00312923|Primary|LDL Cholesterol|Low density lipoprotein cholesterol|12 weeks||||mg/dl||Standard Deviation|Mean
2828664|NCT00312897|Secondary|Clinician's Global Improvement Scale (CGI)|a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|baseline and 10-week treatment phase|3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results|||units on a scale||Standard Deviation|Mean
2828665|NCT00312897|Primary|Children's Depressive Rating Scale - Revised (CDRS-R)|It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).|baseline and 10-weeks|3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results|||units on a scale||Standard Deviation|Mean
2828666|NCT00312884|Primary|Number of Hospitalisations (All Cause)||from randomisation for 180 days||||Number of hospitalisations|||Number
2828667|NCT00312884|Primary|Number of Days Spent in Hospital||From randomisation date for 180 days||||days||Inter-Quartile Range|Median
2828668|NCT00312884|Primary|Patients Hospitalised (All Cause)||From randomisation date to 180 days||||participants|||Number
2828670|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828671|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828672|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828673|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828674|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828675|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828676|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnar™.|||Participants|||Number
2828677|NCT00312858|Other Pre-specified|Antibody Response to Varicella - Geometric Mean Titer|Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2828678|NCT00312858|Other Pre-specified|Antibody Response to Hepatitis A - Geometric Mean Titer|Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures|||mIU/mL||95% Confidence Interval|Geometric Mean
2828679|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828680|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828681|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828682|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828683|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828685|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828686|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828687|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828688|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience.|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828689|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828690|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)|||Participants|||Number
2828691|NCT00312858|Primary|Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers|Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay|6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures|||mcg/mL||95% Confidence Interval|Geometric Mean
2828692|NCT00312858|Primary|Antibody Response to Varicella - Participants With a Serological Response|Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.|||Participants|||Number
2828693|NCT00312858|Primary|Antibody Response to Hepatitis A - Participants With a Serological Response|Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.|||Participants|||Number
2828694|NCT00312845|Secondary|Overall Response Rate|Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC.|||participants|||Number
2828695|NCT00312845|Primary|Progression Free Survival|Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|Intention to treat (ITT) population is defined as all patients randomized to the trial.|||days||95% Confidence Interval|Median
2828696|NCT00312728|Secondary|Number of Participants With Selected Adverse Events|"Number of participants with selected adverse events (all grades based on NCI CTCAE) included any grade CNS hemorrhage, any grade pulmonary hemorrhage, any grade gastrointestinal (GI) perforation, Grade ≥ 2 arterial thromboembolic event, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 non-CNS non-pulmonary hemorrhage, Grade ≥ 3 proteinuria, Grade ≥ 3 proteinuria, Grade ≥ 3 hypertension, any serious adverse event*, and any adverse event leading to study treatment discontinuation.~*For serious adverse events, please see Adverse Event Reporting Section."|From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||participants|||Number
2828697|NCT00312728|Secondary|Number of Participants With OS in First-line and Second-line Settings [1−Year or More Survival]|To assess the number of participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||participants|||Number
2829007|NCT00310050|Primary|Quantitative Toxicity of Pemetrexed When Administered With Concomitant Radiation Therapy||42 days|data were not collected||||||
2828698|NCT00312728|Secondary|OS in First-line and Second-line Settings|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||Months||95% Confidence Interval|Median
2828699|NCT00312728|Secondary|Number of Participants With Overall Survival (OS) in First-line Setting [1−Year or More Survival]|Number of Participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.|||participants|||Number
2828700|NCT00312728|Secondary|Overall Survival (OS) in First-line Setting|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.|||Months||95% Confidence Interval|Median
2828701|NCT00312728|Primary|Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage|"The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage.~Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death"|From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.|||percentage of participants||90% Confidence Interval|Number
2828702|NCT00312702|Secondary|Anti-LSA-1 Antibody Response in Titer Units|Anti-LSA-1 Antibody Response in Titer Units on days 0, 28, 42 and 84|days 0, 28, 42 (challenge day) and 84|Low dose group didn't participate in challenge (day 42) and day 84|||Titer units||Full Range|Median
2828703|NCT00312702|Primary|Safety - Most Frequently Reported Adverse Events and Grade|"An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant.~Grade 1: Mild Grade 2: Moderate Grade 3: Severe"|30 days post vaccination|The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe Infectivity Controls were not included in this analysis.|||Number of adverse events|||Number
2828704|NCT00312663|Secondary|Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84|Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84|Days 0, 28, 42, and 84|nAnti-LSA-1 Antibody Response in Titer units on Days 0, 28, 42 and 84|||Titer units||Full Range|Median
2828705|NCT00312663|Primary|Safety - Most Frequently Reported Adverse Events and Grade|An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to the study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe|30 days post vaccination|"The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Subjects from the IC group were not evaluated for AE's and there for not included in the data.~Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe"|||adverse events|||Number
2828706|NCT00312572|Primary|The Percentage of Subjects Who Completed the 14-day Double-blind Phase.|The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).|14 days|Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization.|||Percentage of Participants||95% Confidence Interval|Number
2828707|NCT00312494|Secondary|Anonymized Pharmacogenomic Blood Draw|Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.|Baseline|All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan.|||mg|||Number
2828708|NCT00312494|Secondary|Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score|LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.|||scores on scale||Standard Error|Least Squares Mean
2828709|NCT00312494|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.|||scores on scale||Standard Error|Least Squares Mean
2828730|NCT00312221|Secondary|The Mean Daily Number of Supplemental Analgesic Medication Tablets|The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.|Double-blind phase (84 days)|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Tablets||Standard Error|Mean
2828710|NCT00312494|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score|PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2828711|NCT00312494|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Scores|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.|Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2828712|NCT00312494|Secondary|Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2828713|NCT00312494|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2828714|NCT00312494|Secondary|Change From Baseline to Week 1 and Week 2 in YMRS|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 1, Week 2|ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.|||scores on scale||Standard Error|Least Squares Mean
2828715|NCT00312494|Primary|Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 3|Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations.|||scores on scale||Standard Error|Least Squares Mean
2828716|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)|"The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.~Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.~A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation||||Weeks||Inter-Quartile Range|Median
2828717|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).|"The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.~Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.~A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation||||Weeks||Inter-Quartile Range|Median
2828718|NCT00312377|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression||||Weeks||Full Range|Median
2828744|NCT00311623|Secondary|Change in Gleason Sum|pretreatment biopsy compared to post-treatment radical prostatectomy specimen|Change from baseline to 15 days post-intervention|Data was not collected for this outcome measure||||||
2828745|NCT00311623|Secondary|p27 as Measured by Immunohistochemistry (IHC)|p27 by IHC in prostate cancer.|Change from baseline to 15 days post-intervention|Data was not collected for this outcome measure||||||
2828719|NCT00312377|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression||||Participants|||Number
2828720|NCT00312377|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression||||Participants|||Number
2828721|NCT00312377|Secondary|Overall Survival (OS) in the Female Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||95% Confidence Interval|Median
2828722|NCT00312377|Secondary|Overall Survival (OS) in the Overall Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months||||Months||95% Confidence Interval|Median
2828723|NCT00312377|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months||||Weeks||95% Confidence Interval|Median
2828724|NCT00312377|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months||||Weeks||95% Confidence Interval|Median
2828725|NCT00312338|Primary|Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42||||Percent of resistant isolates|||Number
2828726|NCT00312338|Primary|Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42||||Percent of resistant isolates|||Number
2828727|NCT00312338|Primary|Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0 and Day 42||||Percent of resistant isolates|||Number
2828728|NCT00312221|Secondary|The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the Double-blind Phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Units on a scale||Standard Error|Mean
2828729|NCT00312221|Secondary|The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase|"The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.~The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst)."|Weeks 4, 8 and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Units on a scale||Standard Error|Mean
2829008|NCT00310050|Primary|Determine Maximum Tolerated Dose of Pemetrexed When Administered With Concomitant Radiation Therapy||42 days|data were not collected||||||
2828731|NCT00312221|Primary|"Average Pain Over the Last 24 Hours Scores at Weeks 4, 8, and 12 of the Double-blind Phase."|"The average pain over the last 24 hours score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12)."|Weeks 4, 8, and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.|||Units on a scale||Standard Error|Mean
2828732|NCT00312208|Secondary|Death From Any Cause (Overall Survival)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up of 65 months|The analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median survival time, median time-to-event was not reached in any group; therefore, number of participants who died was presented.|||Participants|||Number
2828733|NCT00312208|Primary|Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)|The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up 65 months|The primary efficacy analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median disease free survival time, median time-to-event was not reached in any group; therefore, number of participants with relapse was presented.|||Participants|||Number
2828734|NCT00312195|Secondary|The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).|The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.|||Tablets||Standard Error|Least Squares Mean
2828735|NCT00312195|Secondary|The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase|"Note: The total numbers of Subjects w/ineffective treatment or who discont'd for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.|||participants|||Number
2828736|NCT00312195|Secondary|Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment|"The time of ineffective treatment was calculated as the earliest of the following:~The date the subject first took >1 gram of acetaminophen,~The visit date when ineffective treatment was first determined, or~The date the last patch was removed."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.|||Days||Standard Error|Mean
2828737|NCT00312195|Primary|The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.|"Ineffective treatment was defined as:~Subject took >1 gram of acetaminophen in a 24-hour period, or~Subject required a change in transdermal patch (TDS) dose, or~Subject had difficulty in keeping the TDS on, or~Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).~Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment."|Double-blind phase (14 days)|The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase.|||participants|||Number
2828738|NCT00311766|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||70 days|The population for safety analysis included all patients who were randomized and received at least one dose of study medication and had at one safety parameter recorded.|||Participants|||Number
2828739|NCT00311766|Secondary|Number of Participants Whose Wounds Have Healed|Wound healing means that the wound has closed without any drainage|56 days|The population for efficacy analysis will be the Full Analysis (FA) population. The FA analysis included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded.|||participants|||Number
2828740|NCT00311623|Secondary|Activity of Rapamycin as Measured by Prostate Specific Antigen (PSA) Response Prior to Surgery|PSA response to daily rapamycin|Change from baseline to Day 14|Data was not collected for this outcome measure||||||
2828741|NCT00311623|Secondary|Toxicity as Per National Cancer Institute Common Toxicity Criteria v3.0|Dose-limiting toxicity was defined as grade 3/4 neutropenia with fever lasting >7 days, platelets of <100,000/mm3 or associated with bleeding, grade ≥3 non-hematologic toxicity, or irreversible grade 2 toxicity related to rapamycine.|Baseline, 14 days post-intervention, 90-days post-operative|Data was not collected for this outcome measure||||||
2828742|NCT00311623|Secondary|Reduction in Proliferation as Measured by Decrease in Ki-67|Correlate PD efficacy as measured by downstream S6 kinase activity inhibition with markers of reduction in markers of proliferation (change in Ki-67) in prostate tumor specimens.|Baseline, 14 days post-intervention, 90-days post-operative|Data was not collected for this outcome measure||||||
2828743|NCT00311623|Secondary|Increased Apoptosis as Measured by Activated Caspase 3|Correlate PD efficacy as measured by downstream S6 kinase activity inhibition with markers of increased apoptosis (activated caspase 3) in prostate tumor specimens.|Baseline, 14 days post-intervention, 90-days post-operative|Data was not collected for this outcome measure||||||
2828747|NCT00311623|Secondary|Number of Participants With Change in Akt Phosphorylation as Measured by Immunohistochemistry (IHC)|Number of participants with change (increased, decreased or no change) in Akt phosphorylation as measured by immunohistochemistry (IHC)|Change from baseline to 15 days post-intervention|Only 7 participants from the control group and 10 participants in the low-dose arm had adequate paired tissue for analysis. Participants in the high dose arm did not complete the study due to serious adverse events.|||Participants|||Count of Participants
2828748|NCT00311623|Secondary|Pharmacokinetic Response of Rapamycin 6mg as Assessed by Whole Blood Analysis|Snap-frozen prostate tissue was evaluated for tissue rapamycin levels.|Change from baseline to 15 days post-intervention|0/2 participants tolerated this dose. Therefore, data for this outcome measure was not collected.||||||
2828749|NCT00311623|Secondary|Pharmacokinetic Response of Rapamycin 3mg as Assessed by Whole Blood Analysis|Snap-frozen prostate tissue was evaluated for tissue rapamycin levels.|Change from baseline to 15 days post-intervention|Data was not collected for this outcome measure||||||
2828750|NCT00311623|Primary|Pharmacodynamic Response as Assessed by Median Post-treatment S6 Activity H-score|Pharmocodynamic response was taken as ≥60% decrease in the H-score for S6 phosphorylation in the radical prostatectomy tumor tissue compared with the pretreatment (baseline) biopsy tumor tissue. The H-score is a semiquantitative measure of the percentage of cells scoring positive (0-100) multiplied by the intensity of staining (0-3).|Change from baseline to 15 days post-intervention|Only 9 participants from the control group and 13 participants in the low-dose arm had evaluable tissue for analysis. Participants in the high dose arm did not complete the study due to serious adverse events.|||score on a scale||Full Range|Median
2828751|NCT00311623|Primary|Median S6 Kinase Inhibition in Prostate Tumor Tissue at the POD||Change from baseline to 15 days post-intervention|Only 10 participants from the low-dose arm and 8 participants from the control arm had adequate paired tissue for evaluation, due to the lack of availability or inadequacy of either biopsy or radical prostatectomy. The 2 patients from the high-dose arm did not complete due to dose-limiting toxicity.|||percentage of S6 kinase inhibition||Inter-Quartile Range|Median
2828752|NCT00311623|Primary|Pharmocodynamically Optimal Dose (POD) of Rapamycin as Determined by Number of Participants With Greater Than or Equal to 60% Tumor S6 Kinase Inhibition by Immunohistochemistry (IHC).||Day 15 post-intervention|Only 10 participants from the low-dose arm and 8 participants from the control arm had adequate paired tissue for evaluation, due to the lack of availability or inadequacy of either biopsy or radical prostatectomy. The 2 patients from the high-dose arm did not complete due to dose-limiting toxicity.|||Participants|||Count of Participants
2828753|NCT00311584|Primary|Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)|"The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as best response. Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response)."|up to 6 courses of therapy, or about 6 months|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.|||participants|||Number
2828754|NCT00311402|Post-Hoc|Number of Patients With Composite Endpoint of Stroke or Major Bleeding|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828755|NCT00311402|Post-Hoc|Number of Patients With Intracranial Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828756|NCT00311402|Post-Hoc|Number of Patients With Stroke|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828757|NCT00311402|Secondary|Number of Patients With Ischemic Vascular Event Composite Endpoint|This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828893|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 2 minus baseline||||Units on a scale||Standard Error|Mean
2828758|NCT00311402|Secondary|Number of Patients With Other Vascular Events|This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828759|NCT00311402|Secondary|Number of Patients With Acute Coronary Syndrome (ACS)|ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828760|NCT00311402|Secondary|Number of Patients With Transient Ischemic Attack (TIA)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828761|NCT00311402|Secondary|Number of Patients With Subarachnoid Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828762|NCT00311402|Secondary|Number of Patients With Brain (Cerebral) Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828763|NCT00311402|Primary|Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.|||patients|||Number
2828764|NCT00311376|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Number on a Scale (Score)||Standard Deviation|Mean
2828765|NCT00311376|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Centimeters of water (cm H20)||Standard Deviation|Mean
2828766|NCT00311376|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Millimeters (mL) of urine||Standard Deviation|Mean
2828767|NCT00311376|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)|||Number of Weekly Episodes||Standard Deviation|Mean
2828768|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
2828808|NCT00311311|Secondary|Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant|Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2828769|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
2828770|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
2828771|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
2828772|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.|||participants|||Number
2828773|NCT00311363|Secondary|Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 13 had missing data|||points on a scale||Standard Deviation|Mean
2828774|NCT00311363|Secondary|Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 12 had missing data|||hours||Standard Deviation|Mean
2828775|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.|||points on a scale||Standard Deviation|Mean
2828809|NCT00311311|Secondary|Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant|Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||micromole/liter (µmol/L)||Standard Deviation|Mean
2828776|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.|||points on a scale||Standard Deviation|Mean
2828777|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.|||points on a scale||Standard Deviation|Mean
2828778|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 3 had missing data.|||participants|||Number
2828779|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|"The CGI-I scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline."|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.|||participants|||Number
2828780|NCT00311363|Secondary|Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF|The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe.|Days 1 to 168 (Baseline to Week 24 of SB Phase)|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.|||points on a scale||Standard Deviation|Mean
2828781|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828782|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828810|NCT00311311|Secondary|Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant|IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||pg/mL||Standard Deviation|Mean
2828783|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828784|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828785|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828786|NCT00311363|Secondary|Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)|The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm.|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||hours||95% Confidence Interval|Median
2828787|NCT00311363|Secondary|Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)|In the 24-hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM)|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population Participants who were missing severity scores for more than two 30-min windows during a 4-hour period had their maximum severity rating for the 4-hour period set to missing. At Randomization (Week 24), there was one participant in each arm with missing 24-hour RLS Record data.|||participants|||Number
2828788|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
2828789|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||hours||Standard Deviation|Mean
2828811|NCT00311311|Secondary|Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant|Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||pg/mL||Standard Deviation|Mean
2828790|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
2828791|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
2828792|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
2828793|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||percentage of participants|||Number
2828794|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828795|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF|"The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||participants|||Number
2828796|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF|"The CGI-C scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline. For this endpoint, response on the CGI-C was defined as participants with a rating of no change, (score of 4) minimally improved, (score of 3) much improved, (score of 2) or very much improved (score of 1) compared to Randomization (Week 24)."|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||percentage of participants|||Number
2828880|NCT00310440|Secondary|Kyphosis|Kyphosis is evaluated in degrees.|12 months|Per protocol (PP) subjects who had images available at 12 months were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||degrees||Standard Deviation|Mean
2828797|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||points on a scale||Standard Deviation|Mean
2828798|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 184 to 252 (Weeks 26 to 36)|DB ITT Population||||||
2828799|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|DB ITT Population||||||
2828800|NCT00311363|Primary|Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period|"Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 [Week 24] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C)."|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.|||percentage of participants|||Number
2828801|NCT00311311|Secondary|Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline, and 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||mmˆ3/year||Standard Deviation|Mean
2828802|NCT00311311|Secondary|Number of Participants Who Used Anti-hypertensive Medications|"Participants who reported yes for taking anti-hypertensive medications as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||participants|||Number
2828803|NCT00311311|Secondary|Number of Participants Who Used Lipid Lowering Therapies|"Participants who reported yes for taking lipid lowering therapies as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point|||participants|||Number
2828804|NCT00311311|Secondary|Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant|Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.||||||
2828805|NCT00311311|Secondary|Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant|Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points|||µmol/L||Standard Deviation|Mean
2828806|NCT00311311|Secondary|Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant|Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points|||pmol/L||Standard Deviation|Mean
2828807|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant|Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||gram per liter (g/L)||Standard Deviation|Mean
2828812|NCT00311311|Secondary|Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant|TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||pg/mL||Standard Deviation|Mean
2828813|NCT00311311|Secondary|Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.|hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||mg/L||Standard Deviation|Mean
2828814|NCT00311311|Secondary|Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant|Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||microgram per milliliter (µg/mL)||Standard Deviation|Mean
2828815|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant|HbA1C, change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point|||percentage of glucose||Standard Deviation|Mean
2828816|NCT00311311|Secondary|Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant|Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||picomole/liter (pmol/L)||Standard Deviation|Mean
2828817|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant|Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||mmol/L||Standard Deviation|Mean
2828818|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant|Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||millimole/liter (mmol/L)||Standard Deviation|Mean
2828819|NCT00311311|Secondary|Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant|Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.|Pre-conversion baseline, 12, and 24 months post-transplant|Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.||||||
2828820|NCT00311311|Secondary|CIMT at Pre-conversion Baseline|Mean CIMT=average of left CIMT and right CIMT.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline|||mm||Standard Deviation|Mean
2828821|NCT00311311|Secondary|Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant|Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point|||millimeter/year (mm/year)||Standard Deviation|Mean
2828822|NCT00311311|Primary|TPV at Pre-conversion Baseline|TPV is the sum of the assessment in left and right distal common carotid arteries.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline|||mmˆ3||Standard Deviation|Mean
2828823|NCT00311311|Primary|Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline and 12 months post-transplant|On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant|||millimeter cube/year (mmˆ3/year)||Standard Deviation|Mean
2828824|NCT00311181|Primary|DFT (4.5 ms Waveform)||Implant||||Volts||Standard Error|Mean
2828825|NCT00311181|Primary|DFT (2.5 ms Waveform)||Implant||||Volts||Standard Error|Mean
2828826|NCT00311181|Primary|Defibrillation Thresholds (DFTs) (3.5 ms Waveform)||Implant||||Volts||Standard Error|Mean
2828827|NCT00311155|Secondary|Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||mm Hg||Standard Deviation|Mean
2828828|NCT00311155|Secondary|Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||mm Hg||Standard Deviation|Mean
2828829|NCT00311155|Secondary|Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of Participants|||Number
2828830|NCT00311155|Secondary|Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.|Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of participants|||Number
2828831|NCT00311155|Secondary|Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of participants|||Number
2828832|NCT00311155|Primary|The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.|For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.|||Percentage of participants|||Number
2828833|NCT00310856|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination|The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination|From day 1 through day 7 after any vaccination|Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.|||participants|||Number
2828834|NCT00310856|Secondary|hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2828835|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
2828836|NCT00310856|Secondary|hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2828837|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
2828838|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2830676|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2828839|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
2828840|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.|||Percentage of subjects||95% Confidence Interval|Number
2828841|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
2828842|NCT00310856|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.|||Percentage of subjects||95% Confidence Interval|Number
2828843|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.|28 days after first vaccination and 21 days after second vaccination|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.|||Subjects|||Number
2828844|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|From day 1 through day 7 after first or second vaccination(s)|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.|||Subjects|||Number
2828845|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828846|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828847|NCT00310817|Secondary|hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on PP dataset Immunogenicity of a booster dose - subset of subjects in the MITT population who received a booster dose of either MenACWY Ad+/Ad- conjugate vaccine, and provided evaluable serum samples at day 169, 358 & had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828848|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828849|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828850|NCT00310817|Secondary|hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination||||titers||95% Confidence Interval|Geometric Mean
2828851|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828852|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+ / Ad- conjugate vaccine who received a booster dose of either Novartis MenACWY Ad+/ Ad- conjugate vaccine, provided evaluable serum samples at day 169 and 358, had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828853|NCT00310817|Secondary|hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828854|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828855|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828856|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828857|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2829043|NCT00309452|Secondary|Substance Use||every 6 months|This was not a planned primary or secondary outcome in our analysis (though collected at baseline) and because of significant attrition we did not report on this outcome despite having phone call f/u data on other outcomes. We did not believe phone reports on this outcome would produce reliable data.||||||
2828858|NCT00310817|Secondary|hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828859|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828860|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828861|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-)vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828862|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828863|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subjects in the MITT who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine at either 6 or 12 months from the 1st vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the 1st vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828864|NCT00310817|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY(Ad-) vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828865|NCT00310817|Secondary|hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+/PS vaccine, provided evaluable serum samples at day 169 day 358 and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828866|NCT00310817|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2828867|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828868|NCT00310817|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.|||percentages of subjects||95% Confidence Interval|Number
2828869|NCT00310804|Secondary|Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.|Day 1 - Day 181 postvaccination|This analysis was done on safety dataset.|||subjects|||Number
2828870|NCT00310804|Secondary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV."|Day 1 to Day 7 postvaccination|Analysis was done on safety dataset.|||subjects|||Number
2828871|NCT00310804|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine|"Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after~one dose of cTIV for each of the three vaccine lots separately and~one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.~As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination."|Day 22 postvaccination|This analysis was done on PP population.|||Percentages||95% Confidence Interval|Number
2828872|NCT00310804|Primary|Percentage of Subjects With HI Titers ≥40|"Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%."|Day 22 postvaccination|This analysis was done on PP population.|||Percentages||95% Confidence Interval|Number
2828873|NCT00310804|Primary|Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5."|Day 22 postvaccination|The analysis was performed as PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2828874|NCT00310804|Primary|Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"The haemagglutinin Inhibition (HI) antibody titer response following~one dose of cTIV for each of the three lots separately and~one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).~The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.|||Titers||95% Confidence Interval|Geometric Mean
2828875|NCT00310791|Primary|Areal Bone Density by DXA||18-Months||||g/cm2||Standard Deviation|Mean
2828876|NCT00310466|Primary|Daily Rhinoconjunctivitis Rescue Medication Score|Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).|Birch pollen season 2006||||Units on a scale (0-30)||Standard Deviation|Mean
2828877|NCT00310466|Secondary|Adverse Events|An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).|Birch pollen season 2006||||Events|||Number
2828878|NCT00310466|Secondary|Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects|The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).|Birch pollen season 2006||||Participants|||Number
2828879|NCT00310466|Primary|Daily Rhinoconjunctivitis Symptom Score|A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.|Birch pollen season 2006||||Units on a scale (0-18)||Standard Deviation|Mean
2828881|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS) that are comprised of eight domains. The following domains make up the MCS: vitality, social functioning, role-emotional, mental health. The MCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||score on a scale||95% Confidence Interval|Least Squares Mean
2828882|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS) that are comprised of eight domains. The following domains make up the PCS: physical functioning, role-physical, bodily pain, general health. The PCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2828883|NCT00310440|Secondary|Success Rates Measured by Aggregated Modified Odom's Criteria|Subjects selected one of four categories: Excellent (Improvement Greater than or Equal to 80%, Deterioration Less than 10%), Good (Improvement Greater than or Equal to 70%, Deterioration Less than 15%), Fair (Improvement Greater than or Equal to 50%, Deterioration Less than 20%) or Poor (Improvement Less than 50%, Deterioration Greater than 20%).|12 months|Per protocol (PP) subjects that had data available at the 12 month visit were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||participants|||Number
2828884|NCT00310440|Secondary|Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||cm||95% Confidence Interval|Mean
2828885|NCT00310440|Secondary|Mean Change in Pain at Neck Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||cm||95% Confidence Interval|Mean
2828886|NCT00310440|Primary|Complications|Any AE within 12 months of surgery.|12 months|All enrolled subjects.|||participants|||Number
2828887|NCT00310440|Primary|Neurologic Success|The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.|12 months|The total number of observed subjects.|||participants|||Number
2828888|NCT00310440|Primary|Change in of the Overall Neck Disability Index (NDI) Score From Baseline.|The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.|12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2828889|NCT00310440|Primary|Radiologic Fusion|Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion <3mm, and angular motion <5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.|12 months|All participants that have radiological data at 12 months including imputed data.|||participants|||Number
2828890|NCT00310427|Primary|Craving for Alcohol Evoked by Alcohol-cue Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 4||||Units on a scale||Standard Error|Mean
2828891|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 2 minus baseline||||Units on a scale||Standard Error|Mean
2828892|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 1 minus baseline||||Units on a scale||Standard Error|Mean
2828894|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 1 minus baseline||||Units on a scale||Standard Error|Mean
2828895|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1 Rating 2 minus baseline||||Units on a scale||Standard Error|Mean
2828896|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1/Rating 1 minus baseline||||Units on a scale||Standard Error|Mean
2828897|NCT00310427|Primary|Craving for Alcohol (Spontaneous)|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Baseline||||Units on a scale||Standard Error|Mean
2828898|NCT00310401|Secondary|Chest X-ray Findings|Chest radiographs were scored using a radiographic score that scored each quadrant for extent of radiographic infiltrates on a scale of 0 to 4, then summed each quadrant for a total score from 0 (no infiltrates) to 16 (extensive infiltrates in all 4 radiographic quadrants).|change from enrollment to organ procurement (about ~40h after enrollment)||||units on a scale||Standard Deviation|Mean
2828899|NCT00310401|Secondary|Pulmonary Vascular Resistance||72 hours|Insufficient data available to analyze this outcome||||||
2828900|NCT00310401|Secondary|Lung Compliance|Static compliance of the respiratory system using plateau pressure (Pplat) measured at end-inspiration and calculated using the equation static compliance = tidal volume/(Pplat - PEEP)|baseline and at organ procurement (about ~40h after enrollment)||||ml/cmH2O||Standard Deviation|Mean
2828901|NCT00310401|Secondary|Number of Donor Lungs Used for Transplantation|Number of lungs procured and used for transplantation|72 hours||||Participants|||Count of Participants
2828902|NCT00310401|Primary|Donor Oxygenation|The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement|Change from enrollment to organ procurement (about ~40h after enrollment)||||cmH2O||Inter-Quartile Range|Median
2828903|NCT00310388|Secondary|Percentage of Seizure Free Days|A seizure free day is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Percentage of seizure free days is calculated as Number of seizure free days / number of applicable days × 100 percent. Only those participants with data available at the indicated time point were analyzed.|Up to 121 months|Safety Population|||Percentage of days||Standard Deviation|Mean
2828904|NCT00310388|Secondary|Number of Participants Who Were Seizure Free for Any 12 Continuous Months|Seizure free for any continuous 12 months is defined as no seizures occurring during any consecutive 360 days. Number of participants who were seizure free for 12 continuous months within the 121 month OLE period have been presented.|Up to 12 continuous months within the 121 months period|Safety Population|||Participants|||Number
2828905|NCT00310388|Secondary|Number of Participants Who Were Seizure Free for Any 6 Continuous Months|Seizure free for any continuous 6 months is defined as no seizures occuring during any consecutive 180 days between the first date (Baseline) and the last date (before tapering of dose). The number of participants who were seizure free for 6 continuous months within the 121 month OLE period have been presented.|Up to 6 continuous months within the 121 months period|Safety Population|||Participants|||Number
2828906|NCT00310388|Secondary|Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment|A Responder was defined as a participant with >=50 percent decrease from Baseline in the 28-day partial seizure frequency, i.e., a percent change from Baseline less than or equal to -50 percent. The percentage of responders from Baseline phase of the parent study (VRX-RET-E22-302) to open label treatment have been presented.|Baseline and up to 121 months|Safety Population|||Percentage of participants|||Number
2828907|NCT00310388|Secondary|Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment.|28-day partial seizure rate observed during the OLE period was compared to the 28-day partial seizure rate observed during the Baseline phase of the double-blind parent study VRX-R ET-E22-302. Percent change from Baseline in 28-day total partial seizure rate was calculated as ([28-day partial seizure frequency for the period of interest - Baseline 28-day partial seizure frequency] / Baseline 28-day partial seizure frequency) × 100 percent. A negative percent change indicated a reduction (improvement) from Baseline, so the best possible outcome was -100 percent. Only those participants with data available at the indicated time point were analyzed.|Baseline and up to 121 months|Safety Population|||Percent change||Standard Deviation|Mean
2828908|NCT00310388|Secondary|Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration|Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.|3 years and 10 months|All SFUCP Subjects Population|||Days||Full Range|Median
2828945|NCT00310375|Secondary|Percentage Change From Baseline in the 28-day Partial Seizure|Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Percent change||Standard Deviation|Mean
2828909|NCT00310388|Secondary|Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation|Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.|3 years and 10 months|All SFUCP Subjects Population|||Days||Full Range|Median
2828910|NCT00310388|Secondary|Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine|An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.|3 years and 10 months|All SFUCP Subjects Population|||Participants|||Count of Participants
2828911|NCT00310388|Secondary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. Only those participants available at the specified time points were analyzed.|3 years and 10 months|All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.|||Participants|||Count of Participants
2828912|NCT00310388|Secondary|Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination|The parameter assessed was decrease in confrontation visual field from initial examination. Only those participants with data available at the indicated time point were analyzed. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
2828913|NCT00310388|Secondary|Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination|VA refers to the clarity of vision. The parameters assessed were CSD in VA from initial examination which can be explained and CSD in VA from initial examination which cannot be explained. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
2828914|NCT00310388|Secondary|Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa|Abnormal discoloration of the skin was determined by a dermatologist. The parameters assessed were abnormal discoloration of the skin, abnormal discoloration of the lips, abnormal discoloration of the nails, abnormal discoloration of the mucosa, abnormal discoloration of sun-exposed tissue, abnormal discoloration of non sun-exposed tissue. Only those participants with at least one skin exam by the investigator or dermatologist on or before the last dose of retigabine or dermatologist-confirmed discoloration with start date on or before the date of last dose of retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
2828915|NCT00310388|Secondary|Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn)|Non-retinal ocular tissue abnormalities were determined by either an ophthalmologist or retina specialist. Non-ret. Pig. Abn is a composite endpoint assessed by its components: abnormal pigmentation (ABP) of the sclera and/or conjunctiva, ABP of the cornea, ABP of the iris and ABP of the lens. Only those participants with >=1 ophthalmology exam on or before last dose of retigabine are presented.|Up to 121 months|Safety Population|||Percentage of participants|||Number
2828916|NCT00310388|Secondary|Percentage of Participants With Retinal Pigmentary Abnormalities (RPA)|RPA was determined by either an ophthalmologist or retina specialist. RPA is the composite endpoint assessed by its components: pigmentary abnormalities (PA) in the macula, PA in the peripheral retina (PR), PA in both macula and PR and PA at location unspecified. Only those participants with >=1 ophthalmology exam on or before last dose of retigabine are presented..|Up to 121 months|Safety Population|||Percentage of participants|||Number
2828917|NCT00310388|Primary|Percentage of Participants With Abnormal Results of Neurological Examination|A complete neurological examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. Abnormal results were categorized as Abnormal-Not Clinically Significant (A-NCS) and Abnormal and Clinically Significant (A-CS). Only data for abnormal values on neurological examination have been presented. Only those participants available at the specified time points were analyzed.|Baseline and up to 122 months|Safety Population|||Percentage of participants|||Number
2828918|NCT00310388|Primary|Percentage of Participants With Abnormal Results of Physical Examination|A complete physical examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. The investigator assessed the skin at every clinic visit. If abnormal skin discoloration was confirmed, the participant continued to be followed by the dermatologist. If the abnormal skin discoloration was not confirmed, the investigator resumed assessing the participants skin at all scheduled clinic visits. Only data for abnormal values on physical examination have been presented. Only those participants available at the specified time points were analyzed.|Baseline and up to 122 months|Safety Population|||Percentage of participants|||Number
2828946|NCT00310375|Primary|Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration|Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.|2 years 9 months|All SFUCP Subjects Population|||Days||Full Range|Median
2828919|NCT00310388|Primary|Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire|The QOLIE-31-P questionnaire contained 30 items. The subscale scores (seizure worry, overall QOL, emotional well-being, energy-fatigue, cognitive, medication effects, social functioning), the final QOLIE-31-P score and the weighted total score (overall assessment) were calculated according to the scoring algorithm defined by the author. Scores range from 0 to 100 with higher scores indicating better function. Baseline was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Scores on a scale||Standard Deviation|Mean
2828920|NCT00310388|Primary|Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index)|AUA Symptom Index was completed during the first year at Months 1, 3, 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase (second, third, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 (not at all) to 5 (almost always). A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed represented by (n=x).|Baseline and up to 122 months|Safety Population|||Scores on a scale||Standard Deviation|Mean
2828921|NCT00310388|Primary|Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume|The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically. A PVR bladder ultrasound to assess urinary retention was performed during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.) in the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Milliliters||Standard Deviation|Mean
2828922|NCT00310388|Primary|Change From Baseline in Urine Potential of Hydrogen (pH)|Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Points on a scale||Standard Deviation|Mean
2828923|NCT00310388|Primary|Change From Baseline in Urine Specific Gravity|Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Ratio||Standard Deviation|Mean
2828924|NCT00310388|Primary|Change From Baseline in Hematology Parameter Red Blood Cells (RBC)|The hematology parameters included RBC. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||10^12 cells per liter||Standard Deviation|Mean
2828925|NCT00310388|Primary|Change From Baseline in Hemoglobin|The hematology parameters included hemoglobin. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Grams per liter||Standard Deviation|Mean
2828926|NCT00310388|Primary|Change From Baseline in Hematocrit|Blood samples for the assessment of clinical laboratory parameter hematocrit were collected at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Percentage of red blood cells in blood||Standard Deviation|Mean
2828927|NCT00310388|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC)|Hematology parameters included eosinophils, basophils lymphocytes, monocytes, neutrophils, platelet count , and WBC. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||10^9 cells per Liter||Standard Deviation|Mean
2828928|NCT00310388|Primary|Change From Baseline in Total Protein|Clinical chemistry parameter included total protein. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Grams per liter||Standard Deviation|Mean
2828929|NCT00310388|Primary|Change From Baseline in Creatinine, Total Bilirubin and Uric Acid|Clinical chemistry parameters included creatinine, total bilirubin and uric acid. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2828930|NCT00310388|Primary|Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea|Clinical chemistry parameters included bicarbonate, calcium, chloride, cholesterol, Non-fasting Glucose, phosphorus, potassium, sodium and urea. Approximately 7-milliliter sample of blood was drawn for clinical chemistry assays. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Millimoles per liter||Standard Deviation|Mean
2828931|NCT00310388|Primary|Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST)|Clinical chemistry parameters included Alk. Phos., ALT and AST. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||International units per liter||Standard Deviation|Mean
2828932|NCT00310388|Primary|Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia|A 12-lead ECG was performed at all study visits during the Open-Label Treatment Phase during the first year of the open-label extension study (Months 1, 3, 6, 9, 12) and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.). The ECG parameters that were assessed were PR interval, QRS interval, QRS duration, QT interval, and QTc interval. QT intervals were corrected using both Bazett's and Friedericia's formulas. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Milliseconds||Standard Deviation|Mean
2828933|NCT00310388|Primary|Change From Baseline in Body Weight|Weight in pounds or kilograms was measured in ordinary indoor clothing (without shoes) and was recorded at all study visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Kilograms||Standard Deviation|Mean
2828934|NCT00310388|Primary|Change From Baseline in Body Temperature|Vital sign measurement temperature was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Degree Celsius||Standard Deviation|Mean
2829093|NCT00308737|Primary|Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care|Change from Baseline to End of Study in FEV1 by MMRM|Baseline to Month 24|Intention to Treat (ITT)|||liters||Standard Deviation|Mean
2828935|NCT00310388|Primary|Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position|Vital sign measurement HR was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of HR was performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Beats per minute||Standard Deviation|Mean
2828936|NCT00310388|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position|Vital sign measurements (supine and standing blood pressure ) were obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of blood pressure were performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to 122 months|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2828937|NCT00310388|Primary|Kaplan-Meier Estimate of the Probability of Disc. From Study Drug|Kaplan-Meier estimate of the probability of disc. at the specified time for all participants is presented. The time frame of premature study disc. was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who had a taper dose start date, the time of withdrawal was the day before the start of taper dose. Participants who switched to commercial product were censored at the last dose of study drug (excluding taper). All participants who withdrew from the study/treatment prematurely but did not switch to commercial product were counted as an event. Number of participants continuing on retigabine at each time of withdrawal were analyzed (represented by n=x in the category titles).|Up to 122 months|Safety Population|||Percentage Probability of disc.|||Number
2828938|NCT00310388|Primary|Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of participants with treatment emergent AEs leading to treatment disc. up to 122 months have been presented.|Up to 122 months|Safety Population|||Participants|||Number
2828939|NCT00310388|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with impaired liver function. TEAEs refer to an AE for which the onset was on or after Retigabine dose in this study and on or before 30 days after the last Retigabine dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Analysis was performed on the safety population which included participants who took at least 1 dose of study medication after being enrolled in this OLE study.|Up to 122 months|Safety Population|||Participants|||Number
2828940|NCT00310375|Secondary|Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire|The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Assessed up to a maximum of 9 years|Safety Population|||Scores on a scale||Standard Deviation|Mean
2828941|NCT00310375|Secondary|Percentage of Seizure-free Days|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days|Assessed up to a maximum of 9 years|Safety Population|||Percentage of days||Standard Deviation|Mean
2828942|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 12 Continuous Months|Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828943|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 6 Continuous Months|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828944|NCT00310375|Secondary|Number of Responders|A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828947|NCT00310375|Primary|Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation|Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.|2 years 9 months|All SFUCP Subjects Population|||Days||Full Range|Median
2828948|NCT00310375|Primary|Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine|An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.|2 years 9 months|All SFUCP Subjects Population|||Participants|||Number
2828949|NCT00310375|Primary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.|2 years and 9 months|All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.|||Participants|||Number
2828950|NCT00310375|Primary|Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination|Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828951|NCT00310375|Primary|Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828952|NCT00310375|Primary|Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa|An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828953|NCT00310375|Primary|Number of Participants With Pigmentation of Retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828954|NCT00310375|Primary|Number of Participants With Pigmentation of Non-retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population|||Participants|||Number
2828955|NCT00310375|Primary|Number of Participants With Abnormal Results of Neurological Examination|Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Month 108|Safety Population|||Participants|||Number
2828956|NCT00310375|Primary|Number of Participants With Abnormal Results in Physical Examination|A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category|Up to Month 108|Safety Population|||Participants|||Number
2828957|NCT00310375|Primary|Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score|An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population|||Scores on a scale||Standard Deviation|Mean
2829009|NCT00310037|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.|Duration of treatment (up to approximately 2 years)||||participants|||Number
2828958|NCT00310375|Primary|Change From Baseline in Post-void Residual Bladder Ultrasound Volume|Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population|||Milliliter (mL)||Standard Deviation|Mean
2828959|NCT00310375|Primary|Change From Baseline in Urine Power of Hydrogen (pH)|Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||pH units||Standard Deviation|Mean
2828960|NCT00310375|Primary|Change From Baseline in Urine Specific Gravity|Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Dimensionless unit||Standard Deviation|Mean
2828961|NCT00310375|Primary|Change From Baseline in Chemistry Parameter-Total Protein|Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population|||Grams per liter (g/L)||Standard Deviation|Mean
2828962|NCT00310375|Primary|Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)|Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Micromole per Liter (umol/L)||Standard Deviation|Mean
2828963|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea|Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Millimole per liter (mmol/L)||Standard Deviation|Mean
2828964|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)|Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||International units per litre (IU/L)||Standard Deviation|Mean
2828965|NCT00310375|Primary|Change From Baseline in Haemoglobin|Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population|||Grams/Liter (g/L)||Standard Deviation|Mean
2828966|NCT00310375|Primary|Change From Baseline in Haematocrit|Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population|||Volume/Volume (v/v)||Standard Deviation|Mean
2828967|NCT00310375|Primary|Change From Baseline in Hematology Parameter-Red Blood Cell Count|Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population|||10^12 cells/Liter(L)||Standard Deviation|Mean
2829040|NCT00309452|Secondary|Economic Measures Including Service Use, Cost of Care and Forensic Data.|Total annual cost per patient|every 6 months||||dollars||Standard Error|Mean
2828968|NCT00310375|Primary|Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)|Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||10^9 cells/Liter||Standard Deviation|Mean
2828969|NCT00310375|Primary|Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population|||Degree||Standard Deviation|Mean
2828970|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population|||Seconds (sec)||Standard Deviation|Mean
2828971|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Milliseconds (msec)||Standard Deviation|Mean
2828972|NCT00310375|Primary|Change From Baseline in Weight|Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Kilograms||Standard Deviation|Mean
2828973|NCT00310375|Primary|Change From Baseline in Body Temperature|Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available|Baseline and Up to Month 108|Safety Population|||Degree Celsius||Standard Deviation|Mean
2828974|NCT00310375|Primary|Change From Baseline in Heart Rate|Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Beats per Minute||Standard Deviation|Mean
2828975|NCT00310375|Primary|Change From Baseline in Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.|Baseline and Up to Month 108|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2828999|NCT00310180|Primary|5-year Disease-free Survival|Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method, and compared between the two randomized arms (arm B vs. arm C) using stratified log rank test and stratified Cox proportional hazard model.|Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years|All eligible patients who had on-study data and follow-up data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2828976|NCT00310375|Primary|Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug|"The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as events. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title)."|Assessed up to a maximum of 9 years|Safety Population|||Percentage Probability of d/c|||Number
2828977|NCT00310375|Primary|Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug|Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population|||Participants.|||Number
2828978|NCT00310375|Primary|Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population included all participants who took at least 1 dose of study medication|||Participants|||Number
2828979|NCT00310362|Secondary|Preparation Non-adherence-flexible Sigmoidoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the flexible sigmoidoscopy procedure.|3 months|||||||
2828980|NCT00310362|Secondary|Preparation Nonadherence-colonoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the colonoscopy procedure.|3 months|||||||
2828981|NCT00310362|Secondary|Nonattendance-flexible Sigmoidoscopy|Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment|3 months|||||||
2828982|NCT00310362|Primary|Appointment Nonadherence-colonoscopy|Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment|3 months||||nonadherent participants|||Number
2828983|NCT00310310|Other Pre-specified|Epworth Sleepiness Scale (ESS)|ESS is a widely used subjective measure of excessive daytime sleepiness in research and clinical settings. Participants are asked to indicate how likely they would be to fall asleep in eight different situations on a scale from 0 (not likely) to 3 (highly likely). The situations are designed to vary in sleep-inducing capacity. The ESS scoring range is 0-24, with higher scores reflecting greater daytime sleepiness.|1 month|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.|||units on a scale||Standard Deviation|Mean
2828984|NCT00310310|Other Pre-specified|Center for Epidemiological Studies - Depression Scale (Short Form)|"The CES-D is a 10-item self-report measure of depression. The 10-item version has adequate predictive accuracy when compared to the original full-length 20-item version, as well as adequate test-retest correlations and discriminative validity.~The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed."|1 month||||units on a scale||Standard Deviation|Mean
2828985|NCT00310310|Other Pre-specified|Outcome Expectation|"Social-cognitive theory (SCT) measure~1= Not at all important 5= Extremely important 6= Not applicable"|1 month||||units on a scale||Standard Deviation|Mean
2828986|NCT00310310|Other Pre-specified|Self-Efficacy|"Social-cognitive theory (SCT) measure~1= Disagree Completely 5= Agree Completely 6= Not applicable"|1 month||||units on a scale||Standard Deviation|Mean
2828987|NCT00310310|Other Pre-specified|Quality of Well Being Scale (QWB-SA)|The QWB-SA is a generic, preference-based measure that produces a single score appropriate for cost-effectiveness estimates and has been used in veteran and other general adult populations. The advantage of having a single, scaled score instead of multiple separate subscale domains is important for comparing interventions. The QWB-SA is a comprehensive measure of health-related quality of life that consists of 78-items and five sections: (I) acute and chronic symptoms; (II) self-care activities; (III) mobility; (IV) physical activity and performance of physical functioning; and (V) social activity. The level of functioning and the subjective symptom reports are then weighted by preference, or utility, on a scale that ranges from 0 (dead) to 1.0 (optimum function).|1 month||||units on a scale||Standard Deviation|Mean
2828988|NCT00310310|Other Pre-specified|Sleep Apnea Quality of Life Index (SAQLI)|"Sleep Apnea Quality of Life Index (SAQLI) which is a 35-item clinician-administered scale composed of five domains: daily functioning, social interactions, emotional functioning, symptoms, and CPAP side effects. . It has high internal consistency, strong content and construct validity, and adequate concurrent and discriminative validity, and is responsive to changes in HRQOL. The key advantages to inclusion of the SAQLI is that it is the only clinician-administered scale in the study and it contains a CPAP side effect scale that is one of the few valid measures of the frequency and amount of CPAP side effects.~A very large, All the time~A large~A moderate to large~A moderate~A small to moderate~A small~No, None, Not at all"|1 month||||units on a scale||Standard Deviation|Mean
2829000|NCT00310076|Secondary|Number of Events of Toxicity Graded 3 and 4|Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported|up to 60 months||||number of events|||Number
2829001|NCT00310076|Secondary|Progression Free Survival||60 months after treatment||||years||95% Confidence Interval|Median
2829002|NCT00310076|Primary|Time to Progression|Time to progression after surgery was recorded.|9 hours||||years||95% Confidence Interval|Median
2829003|NCT00310050|Secondary|Number of Participants That Survived||1 year||||Participants|||Count of Participants
2828989|NCT00310310|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%).~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|6 Months|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities. We had a few Veterans who skipped this assessment when filling out the project assessment packet.|||units on a scale||Standard Deviation|Mean
2828990|NCT00310310|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%).~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|1 Month|The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.|||units on a scale||Standard Deviation|Mean
2828991|NCT00310310|Primary|CPAP Adherence|The investigators also examined the data obtained at the 6-month time point.|6 months||||hours per night||Standard Deviation|Mean
2828992|NCT00310310|Primary|CPAP Adherence|The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.|1 month||||hours per night||Standard Deviation|Mean
2828993|NCT00310180|Secondary|5-year Disease-free Survival by Individual RS Gene Groups|Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method. 5-year DFS by individual RS gene groups (Proliferation Gene Group, HER2 Gene Group, ER Gene Group, Invasion Gene Group, and Other Genes) will be estimated in each arm.|Assessed every 6 months within 5 years from registration and then annually up to 20 years|||||||
2828994|NCT00310180|Secondary|To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test|Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately.|Assessed at 10 years after study entry|Outcome will never be analyzed.||||||
2828995|NCT00310180|Secondary|5-year Disease-free Survival by Age and Recurrence Score Groups|Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. >25) and age groups (<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method.|Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years|All eligible patients who had on-study data and follow-up data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2828996|NCT00310180|Secondary|5-year Overall Survival|Overall survival (OS) is defined as time from date of randomization or registration to date of death from any cause. The distribution of OS (eg, 5-year OS rate) is estimated using Kaplan-Meier method.|Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years|All eligible patients who had on-study data and follow-up data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2828997|NCT00310180|Secondary|5-year Recurrence-free Interval|Recurrence-free interval (RFS) is defined as time from date of randomization or registration to the date of first recurrence of breast cancer (ipsilateral breast tumor recurrence, local/regional recurrence, distant recurrence) or to the date of death with recurrence, if death is the first manifestation of recurrence. The distribution of RFS (eg, 5-year RFS rate) is estimated using Kaplan-Meier method.|Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years|All eligible patients who had on-study data and follow-up data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2828998|NCT00310180|Secondary|5-year Distant Recurrence-free Interval|Distant recurrence-free interval (DRFI) is defined as time from date of randomization or registration to the date of distant recurrence of breast cancer, or of death with distant recurrence, if death is the first manifestation of distant recurrence. The distribution of DRFI (eg, 5-year DRFI rate) is estimated using Kaplan-Meier method.|Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years|All eligible patients who had on-study data and follow-up data|||percentage of participants||95% Confidence Interval|Number
2829004|NCT00310050|Secondary|Patterns of Response||1 year|Data not collected on all participants.|||Participants|||Count of Participants
2829005|NCT00310050|Secondary|Patterns of Failure||1 year|Data not collected.||||||
2829041|NCT00309452|Secondary|Medication (Including Metabolic) Side Effects||every 6 months|data no collected||||||
2829010|NCT00310037|Secondary|Number of Participants With Complete Response Intensive Chemo-immunotherapy Plus Maintenance or Consolidation Bortezomib|"Complete response is:~Complete disappearance of all detectable clinical and radiographic evidence of target lesions and disappearance of all disease-related symptoms if present prior to therapy and normalization of biochemical abnormalities definitely assignable to NHL~All lymph nodes and nodal masses must have regressed to normal size (<= 1.5 cm in the greatest transverse diameter (GTD) for nodes > 1.5 cm prior to therapy) or <= 1 cm for nodes that were 1.1-1.5 cm in the GTD prior to therapy or by more than 75% in the sum of the products of the GTD~The spleen, if enlarged before therapy, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging studies should no longer be present. Other organs enlarged prior to therapy due to involvement of lymphoma must have decreased in size~If bone marrow was involved by lymphoma prior to treatment, infiltrate must be cleared on repeat bone marrow aspirate"|Up to 10 years||||participants|||Number
2829011|NCT00310037|Secondary|Overall Survival|Overall Survival (OS) was measured from the date of study entry to date of death due to any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years||||years||95% Confidence Interval|Median
2829012|NCT00310037|Primary|Progression-free Survival Rate at 18 Months|Progression free survival (PFS) rate at 18 months was defined as the proportion of patients that were alive and progression-free 18 months after registration into the study. The Kaplan-Meier method of 18 month progression-free survival was calculated..|At 18 months||||percentage of participants||95% Confidence Interval|Number
2829013|NCT00309985|Secondary|QOL Change From Baseline to 3 Months|The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.|Assessed at baseline and 3 months|Patients with both baseline and 3-month QOL assessments are included in this analysis.|||units on a scale||Standard Error|Mean
2829014|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 12 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.|Assessed at 12 months|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2829015|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 6 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.|Assessed at 6 months|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2829016|NCT00309985|Secondary|Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)|Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.|||months||95% Confidence Interval|Median
2829017|NCT00309985|Secondary|Time to Clinical Progression|Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.|||months||95% Confidence Interval|Median
2829018|NCT00309985|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients|||months||95% Confidence Interval|Median
2829019|NCT00309959|Primary|Frequency and Severity of Observed Adverse Effects Assessed by Common Terminology Criteria for Adverse Events (CTCAE)||Up to 5 yearsAssessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up||||participants|||Number
2829020|NCT00309959|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months until disease progression for up to 5 years.|Eligible and treated patients|||participants|||Number
2829042|NCT00309452|Secondary|Subjects Who Committed Self-harm and Violence|The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.|12 months|This data was collected, numbers reflect actual data.|||participants|||Number
2829021|NCT00309946|Secondary|Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity|Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.|Week 1 of course 1|This outcome was not measured/assessed for any of the study subjects.||||||
2829022|NCT00309946|Secondary|Changes in Laboratory Correlates|Examined using paired t-test or Wilcoxon signed-ranks test.|Baseline, days 15 and 29 of course 1, and then every 28 days|This outcome was not measured/assessed for any of the study subjects.||||||
2829023|NCT00309946|Primary|Objective Response Rate, Complete (CR) or Partial (PR) Response|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|Every 8 weeks||||percentage of participants|||Number
2829024|NCT00309907|Secondary|C-reactive Protein Levels|Estimated mean and standard deviation|From baseline to days 7, 14, 21, and 28|The data for baseline were intended to be analyzed for all subjects, therefore, combined result is reported. The data for Days 7, 14, 21 and 28 were intended to be analyzed by subgroups of subjects as pre-specified in the study protocol, therefore combined result us not reported for Etanercept + corticosteroid therapy treatment arm.|||mg/dL||Standard Deviation|Mean
2829025|NCT00309907|Secondary|Plasma Cytokine IL6 Level|Estimated mean and standard error of IL6 level|From baseline to days 7 and 28|Plasma samples were available for biomarker analysis in 26 patients. The data were intended to be analyzed for all subjects, therefore, combined result is reported.|||pg/ml||Standard Error|Mean
2829026|NCT00309907|Secondary|Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0|Grade 3-5 organ toxicities attributable to etanercept.|Up to 56 days|28 patients evaluable for this outcome.|||Patients|||Number
2829027|NCT00309907|Secondary|Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy|Pulmonary response is defined as alive & come off of oxygen .|up to day 56|Total of 28 patients are evaluable for this outcome.|||percentage of participants|||Number
2829028|NCT00309907|Secondary|Survival Rate|Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS.|Up to day 56|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.|||percentage of participants||95% Confidence Interval|Number
2829029|NCT00309907|Primary|Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.|Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.|At day 28|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.|||participants|||Number
2829030|NCT00309777|Secondary|National Cholesterol Education Program (NCEP) LDL-C Target Attainment|Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12|12 week|Full Analysis Set|||Participants|||Number
2829031|NCT00309777|Primary|Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks|Baseline to 12 weeks||||Percent change||Standard Deviation|Mean
2829032|NCT00309751|Secondary|Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target|Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks|12 weeks||||Participants|||Number
2829033|NCT00309751|Primary|Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)|Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)|12 weeks||||percent change||Standard Deviation|Mean
2829034|NCT00309738|Secondary|Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)|Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)|12 weeks|Full analysis set (FAS)|||participants|||Number
2829035|NCT00309738|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|12 weeks|Subjects who completed the treatment period|||mg/dL||Standard Deviation|Mean
2829036|NCT00309608|Secondary|Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
2829037|NCT00309608|Secondary|Percentage of Patients With HbA1c<=7.0% at Week 12|Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.|week 12|This population includes the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used as the imputation rule.|||Percentage of Patients|||Number
2829038|NCT00309608|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
2829039|NCT00309465|Primary|Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery|Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.|Day 1|Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat.|||Percentage of subjects|||Number
2829044|NCT00309452|Secondary|Adherence- in Contact With Mental Health Services|Number of participants in contact with mental health services. Collected via self-report.|1 year|Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.|||participants|||Number
2829045|NCT00309452|Secondary|Treatment Satisfaction||every 6 months|Data was not collected||||||
2829046|NCT00309452|Secondary|Vocationally Engaged||1 year after enrollment|20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.|||participants|||Number
2829047|NCT00309452|Secondary|Quality of Life- Heinrich's Quality of Life Scale|"The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126.~The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health."|12 months||||units on a scale||Standard Deviation|Mean
2829048|NCT00309452|Secondary|Overall Functioning- Global Assessment of Functioning|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning.~The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning."|12 months||||units on a scale||Standard Deviation|Mean
2829049|NCT00309452|Secondary|Relapse|Data was not collected, instead Hospitalization (primary outcome) was used as a proxy|every 6 months|||||||
2829050|NCT00309452|Primary|Number of Patients Hospitalized||1 year after enrollment||||participants|||Number
2829051|NCT00309387|Secondary|Number of Participants With a Decrease in Visual Acuity|Number of participants with a decrease in best corrected visual acuity score from baseline of > 15 letters in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat|||participants|||Number
2829052|NCT00309387|Secondary|Number of Participants Undergoing Cataract Surgery|number of participants undergoing cataract surgery in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat|||participants|||Number
2829053|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities|Number of participants with a 5% increase in area of posterior subcapsular opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat|||participants|||Number
2829054|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Cortical Lens Opacities|Number of participants with a 10% increase in area of cortical opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat|||participants|||Number
2829055|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Nuclear Lens Opacities|number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat|||participants|||Number
2829056|NCT00309387|Primary|Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up|number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.|at yearly intervals from baseline for approximately ten years|Intention to treat analysis|||participants|||Number
2829057|NCT00309244|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population|||Number of events/100 subject-months|||Number
2829058|NCT00309244|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population|||Number of events/subject-month|||Number
2829059|NCT00309244|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|52 Weeks|Safety Population|||percentage of participants|||Number
2829060|NCT00309244|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|52 Weeks|Safety Population|||percentage of participants|||Number
2829061|NCT00309244|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%||Week 52|Intention to treat (ITT); participants with available data at baseline and Week 52.|||participants|||Number
2829062|NCT00309244|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.|||milligrams per deciliter||Standard Error|Least Squares Mean
2829063|NCT00309244|Secondary|Change From Baseline in Weight to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.|||kilogram||Standard Error|Least Squares Mean
2829064|NCT00309244|Primary|Change From Baseline in HbA1c to Week 52||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF); participants with available data at baseline and post-baseline.|||percent||Standard Error|Least Squares Mean
2829094|NCT00308711|Secondary|Days in Hospital for Mother and Neonate|Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.|10 days||||days||Standard Deviation|Mean
2829065|NCT00309166|Secondary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.|At Month 2 and at Month 7, post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2829066|NCT00309166|Secondary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase [ALT], basophils [BAS], creatinine [CREA], eosinophils [EOS] and hematocrit [Hem]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.|At Month 2 and Month 7, post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2829067|NCT00309166|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.|||Participants|||Count of Participants
2829068|NCT00309166|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions|NOCDs include asthma, Chron`s disease, dermatitis atopic. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.|||Participants|||Count of Participants
2829069|NCT00309166|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Day 0-29) after any vaccination, up to 7 months|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2829070|NCT00309166|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature > 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.|Within 7 days (Days 0-6) after each dose and across doses, up to 7 months|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheets.|||Participants|||Count of Participants
2829071|NCT00309166|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (>) 50 mm.|Within 7 days (Days 0-6) after each dose and across doses, up to 7 months|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.|||Participants|||Count of Participants
2829072|NCT00309166|Secondary|Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)|Titers were presented as GMTs.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2829073|NCT00309166|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||Participants|||Count of Participants
2829074|NCT00309166|Primary|Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)|Titers were presented as geometric mean titers (GMT).|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2829075|NCT00309166|Primary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL] in the serum of subjects seronegative before vaccination.|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.|||Participants|||Count of Participants
2829076|NCT00308997|Secondary|Clinical Global Improvement (CGI)Improvement|"CGI score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The range for this score is from 1 to 7.~Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2829077|NCT00308997|Secondary|Change in Total Auditory Hall Rating Scale (AHRS) Score|"Total AHRS score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The score range is from 0-42. This is reported as a difference score and a higher score is an improvement.~Total AHRS score is measured as change relative baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2829078|NCT00308997|Secondary|Change in Hallucination Frequency|"AHRS frequency scale score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The hallucination frequency range is from 0-9. The scores reported are difference scores, and an improvement is a higher score.~Hallucination frequency is one of the variables incorporated into the AHRS (Auditory Hallucinations Rating Scale). The score is measured as change relative to baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2829079|NCT00308997|Primary|Hallucination Change Score (HCS)|"HCS score assessed after 15 sessions, 16 minutes per session, delivered to both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation. For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2829080|NCT00308997|Primary|Hallucination Change Score - Left (HCS-left)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the left superior temporal gyrus.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not included in the analysis|||units on a scale||Standard Deviation|Mean
2829081|NCT00308997|Primary|Hallucination Change Score - Right (HCS-right)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the right superior temporal gyrus.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not analyzed|||units on a scale||Standard Deviation|Mean
2829082|NCT00308737|Primary|FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care|FEV1 decrease of ≥ 15% from Baseline value at last measurement|Baseline to Month 24|Intention to Treat (ITT)|||Participants|||Number
2829083|NCT00308737|Secondary|Change in Weight From Baseline at Month 24|Change from baseline in weight at Month 24|Baseline to Month 24|Safety population at Month 24|||kilograms||Standard Deviation|Mean
2829084|NCT00308737|Secondary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care|Change from baseline in HbA1c at last measurement|Baseline to Month 24|Intention to treat (ITT) with last observation carried forward (LOCF)|||percentage||Standard Deviation|Mean
2829085|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data|||Participants|||Number
2829086|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data|||Participants|||Number
2829087|NCT00308737|Secondary|Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement|TLC Decrease of ≥ 15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data|||Participants|||Number
2829088|NCT00308737|Secondary|Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement|FVC Decrease of ≥15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data|||participants|||Number
2829089|NCT00308737|Secondary|Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM|Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM|Baseline to Month 24|participants in ITT population with available data|||mL/min/mmHg||Standard Deviation|Mean
2829090|NCT00308737|Secondary|Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM|Change from baseline to Month 24 in TLC by MMRM|Baseline to Month 24|participants in ITT population with available data|||liters||Standard Deviation|Mean
2829091|NCT00308737|Secondary|Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM|Change from Baseline to Month 24 in FVC by MMRM|Baseline to Month 24|Intention to Treat (ITT)|||liters||Standard Deviation|Mean
2829092|NCT00308737|Secondary|Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care|Change from Baseline to last measurement(Month 24) in FEV1|Baseline to Month 24|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||liters||95% Confidence Interval|Least Squares Mean
2829097|NCT00308711|Secondary|Minutes to Onset of Active Labor|Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.|2880 minutes||||minutes||Standard Deviation|Mean
2829098|NCT00308711|Secondary|Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert|Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.|12 hours||||Percentage of Participants|||Number
2829099|NCT00308711|Secondary|Percentage of Participants With Pre-Delivery Oxytocin Use|Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.|2880 minutes|This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery.|||Percentage of participants|||Number
2829100|NCT00308711|Secondary|Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events|"This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the Maternal/Fetal period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods."|96 hours|Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina.|||Percentage of participants|||Number
2829101|NCT00308711|Primary|Percentage of Participants With a Cesarean Section Delivery|Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.|2880 minutes||||Percentage of participants|||Number
2829102|NCT00308711|Primary|Minutes From Drug Insertion to Vaginal Delivery|Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.|2880 minutes|This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.|||minutes||95% Confidence Interval|Median
2829103|NCT00308620|Secondary|Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks|The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.|8 weeks|Analysis of Chloroquine arms is pooled.|||percentage change||Full Range|Median
2829104|NCT00308620|Primary|HIV Viral Load Change|HIV-1 viral load change between baseline and 8 weeks|baseline and 8 weeks||||log10 copies/mL||Standard Deviation|Log Mean
2829105|NCT00308581|Secondary|CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.|Last visit on or before Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829106|NCT00308581|Secondary|CRP Level at Week 26 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829107|NCT00308581|Secondary|CRP Level at Week 24 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829108|NCT00308581|Secondary|CRP Level at Week 22 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 22 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
2829109|NCT00308581|Secondary|CRP Level at Week 20 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829110|NCT00308581|Secondary|CRP Level at Week 18 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 18 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
2829111|NCT00308581|Secondary|CRP Level at Week 16 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829112|NCT00308581|Secondary|CRP Level at Week 14 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 14 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
2829113|NCT00308581|Secondary|CRP Level at Week 12 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829114|NCT00308581|Secondary|CRP Level at Week 10 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 10 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)|||mg/L||Inter-Quartile Range|Median
2829115|NCT00308581|Secondary|CRP Level at Week 8 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829116|NCT00308581|Secondary|CRP Level at Week 6 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829117|NCT00308581|Secondary|CRP Level at Week 4 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829118|NCT00308581|Secondary|CRP Level at Week 2 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829119|NCT00308581|Secondary|C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 0|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||mg/L||Inter-Quartile Range|Median
2829120|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 26|ITTR population taking steroids at baseline|||participants|||Number
2829121|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 24|ITTR population taking steroids at baseline|||participants|||Number
2829122|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 22|ITTR population taking steroids at baseline|||participants|||Number
2829123|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 20|ITTR population taking steroids at baseline|||participants|||Number
2829124|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 18|ITTR population taking steroids at baseline|||participants|||Number
2829125|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 16|ITTR population taking steroids at baseline|||participants|||Number
2829126|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 14|ITTR population taking steroids at baseline|||participants|||Number
2829127|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 12|ITTR population taking steroids at baseline|||participants|||Number
2829128|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 10|ITTR population taking steroids at baseline|||participants|||Number
2829129|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 26|ITTR population taking steroids at baseline|||participants|||Number
2829130|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 24|ITTR population taking steroids at baseline|||participants|||Number
2829131|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 22|ITTR population taking steroids at baseline|||participants|||Number
2829310|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168|P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|168 weeks|Non-completers = failure analysis|||Percent of Participants|||Number
2829132|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 20|ITTR population taking steroids at baseline|||participants|||Number
2829133|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 18|ITTR population taking steroids at baseline|||participants|||Number
2829134|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 16|ITTR population taking steroids at baseline|||participants|||Number
2829135|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 14|ITTR population taking steroids at baseline|||participants|||Number
2829136|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 12|ITTR population taking steroids at baseline|||participants|||Number
2829137|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 10|ITTR population taking steroids at baseline|||participants|||Number
2829138|NCT00308581|Other Pre-specified|Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6|Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.|Week 6 to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||days||Full Range|Median
2829139|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829140|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829141|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829142|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829143|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829144|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829145|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829146|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829147|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829148|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829149|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829150|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829151|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829152|NCT00308581|Secondary|CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829153|NCT00308581|Secondary|CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829154|NCT00308581|Secondary|CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829155|NCT00308581|Secondary|CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829156|NCT00308581|Secondary|CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829157|NCT00308581|Secondary|CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829158|NCT00308581|Secondary|CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829159|NCT00308581|Secondary|CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829311|NCT00307489|Secondary|HBsAg Loss at Week 168|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|168 weeks||||Participants|||Number
2829160|NCT00308581|Secondary|CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829161|NCT00308581|Secondary|CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829162|NCT00308581|Secondary|CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829163|NCT00308581|Secondary|CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829164|NCT00308581|Secondary|CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)|||points on a scale||Standard Deviation|Mean
2829165|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase|||participants|||Number
2829166|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: subjects who received at least one dose of study drug in the induction phase|||participants|||Number
2829167|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase|||participants|||Number
2829168|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase|||participants|||Number
2829169|NCT00308581|Secondary|Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase|Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase|||participants|||Number
2829170|NCT00308581|Primary|Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase|"Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.~The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."|Baseline to Week 6|Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase|||participants|||Number
2829171|NCT00308555|Primary|Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use|Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.|Day 1, Day 5|The number was determined by the number of participants completing both Day 1 and Day 5 procedures.|||Geometric Mean Ratio||95% Confidence Interval|Number
2829172|NCT00308516|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months|||||||
2829173|NCT00308516|Primary|Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|24 months||||percentage of participants||95% Confidence Interval|Number
2829176|NCT00308308|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|Baseline to Week 52|Safety Population|||percentage of participants|||Number
2829177|NCT00308308|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|Baseline to Week 52|Safety population|||percentage of participants|||Number
2829178|NCT00308308|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%|Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%|Baseline to Week 52|participants in ITT population with available data|||Participants|||Number
2829179|NCT00308308|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52|Change from baseline in fasting plasma glucose at Week 52|Baseline to Week 52|participants in ITT population with available data|||mg/dl||Standard Error|Least Squares Mean
2829180|NCT00308308|Secondary|Change From Baseline in Weight to Week 52|Change from baseline in weight at Week 52|Baseline to Week 52|participants in ITT population with available data|||kilogram||Standard Error|Least Squares Mean
2829181|NCT00308308|Primary|Compare the Mean Change From Baseline to Week 52 in HbA1c||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF)|||Percentage||Standard Error|Least Squares Mean
2829182|NCT00308282|Secondary|Change From Baseline in CD20+ B Cell Number Count|CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of Rheumatoid Arthritis (RA). A reduction in CD20+ B-cell values may indicate an improvement in RA symptoms.|Baseline, Week 24|All participants who received one dose of study drug and had post baseline CD20+ cell data.|||Cells per microLiter||Standard Deviation|Mean
2829183|NCT00308282|Secondary|Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM|Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. A negative change indicates a decrease in Ig levels.|Baseline, Week 24|All participants who received one dose of study drug and had post baseline serum immunoglobulin data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2829184|NCT00308282|Secondary|European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses|EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders (NR) based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.|Baseline, Week 24|All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value.|||percentage of participants|||Number
2829185|NCT00308282|Secondary|Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A negative change indicated an improvement.|Baseline, Week 24|All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value.|||units on a scale||Standard Deviation|Mean
2829186|NCT00308282|Secondary|Percentage of Participants Achieving ACR 50 and ACR70|ACR Responder Index: composite of clinical, laboratory, and functional measures of Rheumatoid Arthritis (RA). ACR50 and ACR70 Responder: had either a ≥50% or ≥70% improvement from baseline in both tender and swollen joint counts and either a ≥50% or ≥70% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP (respectively).|Baseline through Week 24|All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value.|||percentage of participants|||Number
2829187|NCT00308282|Secondary|Evaluation of the Pharmacokinetics of LY2127399: Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose|All participants who received at least one dose of LY2127399 and had evaluable PK data.|||Liters per Hour (L/Hr)||Standard Deviation|Mean
2829188|NCT00308282|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms)|"Treatment-emergent adverse events (TEAEs) were defined as those AEs with start date and time equal to or after the start of study medication infusion. In the case of a missing onset time for an AE, an AE with a start date equal to or greater than the dosing date was considered treatment-emergent. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.~All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received."|Baseline through Study Completion (Up to 19 Months)|All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received.|||Participants|||Count of Participants
2829189|NCT00308282|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)|ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP).|Week 16|All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value.|||percentage of participants|||Number
2829190|NCT00308230|Primary|BNP Levels|Levels of B-type naturietic peptide in the blood|1 day||||pg/ml||Standard Deviation|Mean
2829191|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and not using SU at screening.|||events per subject-year||Standard Error|Mean
2829192|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and using SU at screening.|||events per subject-year||Standard Error|Mean
2829193|NCT00308139|Secondary|Ratio of Triglycerides at Week 364 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||95% Confidence Interval|Least Squares Mean
2829194|NCT00308139|Secondary|Ratio of Triglycerides at Week 30 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||Standard Error|Least Squares Mean
2829195|NCT00308139|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364|Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829196|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829197|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2829198|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 364|Change in total cholesterol from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829199|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2829200|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 364|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364|Day -3, Week 364|7-Year Completer Population using observed data.|||mmHg||Standard Deviation|Mean
2829201|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 30|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30|Day -3, Week 30|ITT Population using observed data.|||mmHg||Standard Error|Mean
2829202|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 364|Change in fasting plasma glucose from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829203|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 30|Change in fasting plasma glucose from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2829204|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 364|Change in body weight from baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
2829205|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight from baseline (Day -3) to Week 30|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||Standard Error|Least Squares Mean
2829206|NCT00308139|Secondary|Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.|Week 22|||||||
2829207|NCT00308139|Secondary|Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14|Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14|Day -3, Week 14|Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
2829208|NCT00308139|Secondary|Exenatide LAR Steady State Concentration From Week 29 to Week 30|Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.|Week 29 to Week 30|The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.|||pg/mL||Inter-Quartile Range|Geometric Mean
2829209|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0%|Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2829210|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2829211|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2829212|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2829213|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentage of subjects achieving HbA1c target value of <7% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
2829214|NCT00308139|Primary|Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval|Week 22|||||||
2829215|NCT00308139|Secondary|Change in HbA1c From Baseline to Week 364|Absolute change in HbA1c from Baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
2829216|NCT00308139|Primary|Change in HbA1c From Baseline to Week 30|Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]|Day -3, Week 30|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2829217|NCT00308113|Secondary|Compare Side Effect Profiles of the Three Study Groups|To compare side effect profiles of the three regimens to the enhanced standard of care group, to include height, weight, weight/height ratio, body mass index, cataract formation, blood glucose, blood pressure, and behavioral changes.|12 months|No analysis was performed as the study was closed with N=3 out of 120 and side effects profile between groups could not be analyzed.||||||
2829218|NCT00308113|Primary|One Year Change in Pulmonary Function (Forced Expiratory Volume, FEV1 and Forced Vital Capacity, FVC)|Comparing change from baseline levels in pulmonary function (FEV1 and FVC) in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year.|12 months|No analysis was performed as only 1 out of 3 participants completed all the pulmonary function measurements before the protocol was closed.||||||
2829219|NCT00308113|Primary|One Year Change of Left Ventricular Mean Systolic Wall Stress/Rate-corrected Velocity of Fiber Shortening Relation.|Comparing change from baseline of mean systolic wall stress and rate-corrected mean velocity of circumferential shortening in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year. The values are obtained via an echocardiogram read locally at each site.|12 months|No analysis was performed as only 1 out of 3 participants completed all echocardiogram measurements before the protocol was closed.||||||
2829220|NCT00308087|Secondary|Summary of Cost Effectiveness|A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.|24 months|No participants were analyzed because the study was terminated early due to low enrollment.||||||
2829221|NCT00308087|Secondary|Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment|Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.|24 months|Intent to treat population.|||Days||Inter-Quartile Range|Median
2829222|NCT00308087|Secondary|Kaplan-Meier Estimates of Progression-Free Survival|Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.|24 months|Intent to treat population|||Days||Inter-Quartile Range|Median
2829223|NCT00308087|Secondary|Participant Summary of Best Response Across All Visits|"Count of participants' best response within categories defined by the International Working Group (IWG):~> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),~> Complete Response Unconfirmed (unconfirmed complete disappearance),~> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),~> Stable Disease (neither response nor disease progression),~> Progression (new lesion or increase by 50% of previously involved sites from nadir)."|up to 24 months|Intent to treat population|||participants|||Number
2829224|NCT00308087|Secondary|Summary of Treatment-Emergent Adverse Events (TEAE)|Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.|up to 12 weeks|Safety population|||participants|||Number
2829225|NCT00308087|Primary|Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12|Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.|Week 8 (confirmed at Week 12)|Intent to treat population|||participants|||Number
2829226|NCT00308074|Secondary|Brief Psychiatric Rating Scale for Children (BPRS-C)|"The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician' s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from Not Present (scores 0) to Extremely Severe (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
2829227|NCT00308074|Secondary|Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
2829228|NCT00308074|Primary|Aberrant Behavior Checklist-Irritability Subscale|"Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement.~There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
2829229|NCT00308074|Primary|Clinical Global Impressions-Improvement|The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.||||units on a scale||Standard Deviation|Mean
2829312|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168|Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline.|168 weeks|Non-completer = Failure Analysis|||Participants|||Number
2829230|NCT00308061|Secondary|Geometric Mean Titers for Anti-FMP1 Antibody|Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.|Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364|Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.|||geometric mean titers||95% Confidence Interval|Geometric Mean
2829231|NCT00308061|Primary|Number of Participants With Solicited Adverse Events by Immunization and Type|Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.|Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67||||Participants|||Count of Participants
2829232|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
2829233|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
2829234|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
2829235|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
2829236|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14|The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||Units on a scale||Standard Deviation|Mean
2829237|NCT00307931|Secondary|C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14||Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||mg/L||Standard Deviation|Mean
2829238|NCT00307931|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||score on a scale|||Number
2829239|NCT00307931|Secondary|Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||score on a scale|||Number
2829240|NCT00307931|Secondary|Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 6 and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).|||participants|||Number
2829241|NCT00307931|Secondary|Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.|||participants|||Number
2829242|NCT00307931|Secondary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).|||participants|||Number
2829243|NCT00307931|Primary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline, Week 6|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).|||participants|||Number
2829244|NCT00307801|Post-Hoc|Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||mL||Standard Deviation|Mean
2829245|NCT00307801|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||Proportion of participants|||Number
2829246|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829247|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829248|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829249|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829250|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829251|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829252|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829253|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829254|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829255|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829256|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829257|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829258|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829259|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829260|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829261|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829262|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||days||Standard Deviation|Mean
2829263|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||days||Standard Deviation|Mean
2829264|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure|||Proportion of participants|||Number
2829265|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure|||Proportion of participants|||Number
2829266|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829267|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829313|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 168|Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline.|168 weeks|Non-completer = Failure Analysis|||Percent of Participants|||Number
2829314|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 168|Subjects with elevated ALT at baseline that return to normal by Week 48.|168 weeks||||Percent of Participants|||Number
2829268|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829269|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829270|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829271|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829272|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829273|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||Scores on a scale||Standard Deviation|Mean
2829274|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 196|Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure|||ng/mL||Standard Deviation|Mean
2829275|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 84|Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure|||ng/mL||Standard Deviation|Mean
2829276|NCT00307801|Secondary|Change From Baseline in Hematocrit at Treatment Day 196.|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure|||ng/mL||Standard Deviation|Mean
2829277|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure|||g/dL||Standard Deviation|Mean
2829278|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|Baseline (visit 5) and treatment day 84|ITT, all participants with assessments at baseline and day 84 for this outcome measure|||g/dL||Standard Deviation|Mean
2829279|NCT00307801|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments for baseline and efficacy phase for this outcome measure|||Sanitary protection products||Standard Deviation|Mean
2829315|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 168|ULN for males = 43 U/L; ULN for females = 34 U/L|168 weeks|Non-completers = failure analysis|||Percent of Participants|||Number
2829280|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure|||Bleeding days||Standard Deviation|Mean
2829281|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure|||Bleeding episodes||Standard Deviation|Mean
2829282|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.|||ml||Standard Deviation|Mean
2829283|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.|||ml||Standard Deviation|Mean
2829284|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.|||ml||Standard Deviation|Mean
2829285|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT consisted of all randomized subjects enrolled with excessive bleeding. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|||ml||Standard Deviation|Mean
2829286|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure|||ml||Standard Deviation|Mean
2829287|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure|||ml||Standard Deviation|Mean
2829288|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure|||ml||Standard Deviation|Mean
2829316|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168||168 weeks|Non-completers = failure analysis|||Percent of Participants|||Number
2829317|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168||168 weeks|Non-completers = failure analysis|||U/mL||Standard Deviation|Mean
2829318|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 168||168 weeks|Non-completers = failure analysis|||log10 copies/mL||Standard Deviation|Mean
2829289|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure|||ml||Standard Deviation|Mean
2829290|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196|"According to the patient´s global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 196 compared with admission to the study condition."|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure|||Proportion of participants|||Number
2829291|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84|"According to the patient's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 84 compared with admission to the study condition."|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure|||Proportion of participants|||Number
2829292|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196|"According to the investigator's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 196 compared with admission to study data."|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure|||Proportion of participants|||Number
2829293|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84|"According to the investigator's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data."|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure|||Proportion of participants|||Number
2829294|NCT00307801|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall. Cure from frequent bleeding: no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and no increase from baseline in an individual patient's total number of bleeding days occurred|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall||||||
2829295|NCT00307801|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in)|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day run-in period, as assessed by the alkaline hematin method|||Proportion of participants|||Number
2829296|NCT00307801|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects with prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days|||Proportion of participants|||Number
2829319|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48|Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure|||participants|||Number
2829320|NCT00307489|Secondary|HBsAg Loss at Week 48|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure|||participants|||Number
2829321|NCT00307489|Secondary|HBeAg Seroconversion at Week 48|Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive Baseline HBeAg. Non-Completers=Failure|||participants|||Number
2829297|NCT00307801|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) >7 days, no >4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no >1 BE increase from baseline, no increase from baseline in individual patient's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|Intent-To-Treat (ITT): all randomized subjects with ≥1 of the DUB symptoms in 90-day run-in phase: Prolonged bleeding: ≥2 bleeding episodes, each lasting ≥8 days Frequent bleeding: >5 bleeding episodes, with minimum of 20 bleeding days overall. Excessive bleeding: ≥2 bleeding episodes each with blood loss volume (=MBL) of ≥80 mL|||Proportion of participants|||Number
2829298|NCT00307736|Other Pre-specified|Pathologic Complete Response|The number of subjects who achieved a pathologic complete response as determine by pathologist, following completion of the study therapy. Pathologic complete response represents the absence of residual invasive disease in the rectum and in the regional lymph nodes.|3 years|Patients who completed study therapy.|||Participants|||Count of Participants
2829299|NCT00307736|Secondary|Post-operative Complications After Resection of Rectal Cancers Following Preoperative 5-FU, Bevacizumab, Erlotinib, and External Beam Radiation Therapy.|Surgical morbidity following R0 resection with one of the following procedures: abdominal perineal resection, low anterior resection, and low anterior resection with coloanal anastomosis.|3 years|Total study population excluding one patient who refused surgery.|||participants|||Number
2829300|NCT00307736|Secondary|Percentage of Participants With Disease-free Survival|Summary of disease free survival at 1, 2, and 3 years. Disease free survival is the length of time after primary treatment for cancer ends that the participant survives without any clinical signs or symptoms of that cancer. The data is shown of the percentage of participants still in disease free survival at one, two, and three years.|1, 2, 3 years||||percentage of participants||95% Confidence Interval|Number
2829301|NCT00307736|Secondary|Summary of Grade 3 or Greater Toxicity|"Summary of grade 3 or greater toxicity by grade and type. All adverse events were evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.~Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4 Life-threatening consequences; urgent intervention indicated."|3 years|Toxicity was grouped together for all phase I dose cohorts and the phase II cohort in order to summarize all the grade 3 or greater toxicities associated with the combined study therapy, instead of focusing on the dose limiting toxicities from the phase 1 dose escalation of Erlotinib. Grade 3 or higher AE data is not available by dose cohort.|||participants|||Number
2829302|NCT00307736|Primary|Maximum Tolerated Dose (MTD) of Erlotinib When Administered in Combination With 5-fluorouracil (5-FU), Bevacizumab, and External Beam Radiation Therapy|MTD of Erlotinib was determined using a traditional 3 + 3 dose escalation scheme of three dose levels (50,100,150mg). Successive cohorts of 3-6 patients were enrolled into dose escalation cohorts for 14 day cycles. MTD reflects the highest dose of Erlotinib that had ≤1 out of 6 patients with Dose-Limiting Toxicity (DLT) at the highest dose level below the maximally administered dose. The maximally administered dose is the first dose that causes DLT in >33% of patients. DLT was defined as: Any grade 4 neutropenia, Any grade 3 thrombocytopenia, or Any ≥ grade 3 non-hematologic toxicity that results in greater than 7 days interruption in therapy.|3 years||||mg|||Number
2829303|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score|Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104|DB baseline, DB endpoint||||units on a scale||Standard Deviation|Mean
2829304|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CGI-S Score|evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject's illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe).|DB baseline, DB endpoint|Intent to treat: all subjects who used study medication at least once|||units on a scale||Standard Deviation|Mean
2829305|NCT00307684|Secondary|Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint|Quality of life measured by Q-LES-Q best score: 100 worst score: 0|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
2829306|NCT00307684|Secondary|Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint|Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
2829307|NCT00307684|Primary|Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint|"To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.~CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54~Endpoint: last available post-baseline assessment."|DB baseline, DB endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
2829308|NCT00307684|Secondary|Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores|"Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.~Subscale scores: best value: 0, worst value: 27"|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once|||units on a scale||Standard Deviation|Mean
2829309|NCT00307684|Primary|Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)|To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)|Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks|intent-to-treat: all subjects who used the study medication at least once|||participants|||Number
2829328|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48||48 weeks|Randomized and Treated (RAT) subjects at Week 48 - Non-Completers=Failure (ie, includes subjects who switched to open-label FTC/TDF at or after Week 24)|||percentage of participants|||Number
2829329|NCT00307437|Secondary|Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52|Number of visits at which participants randomized at Week 28 achieved at least 75 percent improvement from baseline in PASI from Week 40 through Week 52 in participants randomized at Week 28. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 40 to Week 52|All participants randomized at Week 28 were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.|||Participants||Inter-Quartile Range|Median
2829330|NCT00307437|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the partcipant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Units on a scale||Inter-Quartile Range|Median
2829331|NCT00307437|Secondary|Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0 [none] to 5 [severe]) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.|||Participants|||Number
2829332|NCT00307437|Primary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12|Number of participants achieving greater than or equal to 75 percent improvement in PASI at Week 12. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.|||Participants|||Number
2829333|NCT00307333|Secondary|Mortality||120 days||||participants|||Number
2829334|NCT00307333|Secondary|Days on Antibiotics||120 days||||days||Standard Deviation|Mean
2829335|NCT00307333|Secondary|Duration of Hospital Stay||120 days||||days||Standard Deviation|Mean
2829336|NCT00307333|Primary|Number of Ventilator-free Days||120 days||||days||Standard Deviation|Mean
2829337|NCT00307294|Secondary|Time to Progression|Time from start of treatment until the disease progression per RECIST criteria.|Up to 18 months||||months||95% Confidence Interval|Median
2829338|NCT00307294|Secondary|Overall Survival||36 months||||months||95% Confidence Interval|Median
2829339|NCT00307294|Secondary|Best Overall PSA Response|PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.|4 weeks|Patients that received greater than one cycle of therapy and met criteria for stable or progressive disease according to Prostate-Specific Antigen Working Group criteria.|||percentage of patients||95% Confidence Interval|Number
2829340|NCT00307294|Primary|Response Rate|The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.|24 weeks|Patients that received greater than one cycle of therapy.|||percentage of participants||95% Confidence Interval|Number
2829341|NCT00307164|Secondary|Change in Creatine Kinase From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 creatine kinase data was missing and post-baseline creatine kinase was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||IU/L||Inter-Quartile Range|Median
2829342|NCT00307164|Secondary|Change in Leukocytes From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 leukocyte data was missing and post-baseline leukocyte was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||cells*10^3/L||Inter-Quartile Range|Median
2829343|NCT00307164|Secondary|Change in Hemoglobin From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 hemoglobin data was missing and post-baseline hemoglobin was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||g/dL||Inter-Quartile Range|Median
2829344|NCT00307164|Secondary|Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting triglyceride data was missing and post-baseline fasting triglyceride was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
2829345|NCT00307164|Secondary|Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting LDL data was missing and post-baseline fasting LDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
2829346|NCT00307164|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting non-HDL data was missing and post-baseline fasting non-HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF or due to associated triglyceride was >400 mg/dL. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
2829347|NCT00307164|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
2829348|NCT00307164|Secondary|Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting total cholesterol was missing and post-baseline fasting total cholesterol was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
2829349|NCT00307164|Secondary|Change in Fasting Glucose From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting glucose was missing and post-baseline fasting glucose was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mg/dL||Inter-Quartile Range|Median
2829350|NCT00307164|Secondary|Change in Fasting Lactate From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting lactate was missing and post-baseline fasting lactate was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||mmol/L||Inter-Quartile Range|Median
2829351|NCT00307164|Secondary|Change in CD4+ Count From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 CD4+ data was missing and post-baseline data was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||cells/mm3||Inter-Quartile Range|Median
2829352|NCT00307164|Secondary|HIV-1 RNA Level||At Week 48|Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48.|||Participants|||Number
2829353|NCT00307164|Secondary|Change in Limb Fat From Baseline (Week 24 - Baseline)|Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.|Baseline and Week 24|Intention to treat analysis with LOCF if week 24 limb fat data was missing and post-baseline before week 24 limb fat observation was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||grams||Inter-Quartile Range|Median
2829354|NCT00307164|Secondary|Number of Subjects Discontinuing Study Medication|Number of eligible subjects who discontinued study medication during the study period.|Through Week 48|Intention to treat analysis based on all subjects who started study treatment.|||Participants|||Number
2829355|NCT00307164|Secondary|Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)|Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry|Through Week 48|As-treated analysis with subjects stratified based on ART (d4T or AZT).|||weeks||Inter-Quartile Range|Median
2829356|NCT00307164|Primary|Change in Limb Fat (g) From Baseline|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|Baseline and Week 48|Intention to treat analysis with last observation carried forward (LOCF) if week 48 limb fat data was missing and post-baseline limb fat was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).|||grams||Inter-Quartile Range|Median
2829357|NCT00307151|Secondary|Time From Randomization to Death|Results report 2nd percentile of time from randomization to death|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
2829358|NCT00307151|Secondary|Time From Randomization to HIV-related Disease Progression or Death|HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
2829359|NCT00307151|Secondary|Change in CD4 Percent From Entry to Week 48|Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.|48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort|||Percent of CD4||95% Confidence Interval|Mean
2829360|NCT00307151|Secondary|Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus|Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.|||participants|||Number
2829435|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days|ITT population|||percentage of participants|||Number
2829361|NCT00307151|Secondary|Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment|Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.|On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first|||Weeks||95% Confidence Interval|Number
2829362|NCT00307151|Secondary|Time From Randomization to Virologic Failure|Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
2829363|NCT00307151|Secondary|Percent of Participants Experiencing Virologic Failure|Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population.|||Percent of participants|||Number
2829364|NCT00307151|Secondary|Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population|||Weeks||95% Confidence Interval|Number
2829365|NCT00307151|Primary|Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population|||Percent of participants|||Number
2829366|NCT00307125|Secondary|Number of Participants With Viral Replication of Polyomavirus (BKV)|Number of participants with viral replication of BKV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of a BKV infection. Polyomavirus BK is a significant pathogen in transplant recipients.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829367|NCT00307125|Secondary|Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV)|Number of participants with positive viral replication of EBV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of EBV viral replication is indicative of active infection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829368|NCT00307125|Secondary|Number of Participants With Viral Replication of Cytomegalovirus (CMV)|Number of participants with viral replication of CMV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of active CMV infection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829369|NCT00307125|Secondary|Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy|Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829370|NCT00307125|Secondary|Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD)|Number of participants with PTLD within 12 month post treatment initiation. Diagnosis of PTLD was made by B cell proliferation after therapeutic immunosuppression.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829371|NCT00307125|Secondary|Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation|Number of participants with graft loss, defined as the need for dialysis for greater than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure within 12 month post treatment initiation|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829372|NCT00307125|Secondary|Number of Deaths 12 Months Post Treatment Initiation|Number of participant deaths within 12 months post treatment initiation|12 months post treatment initiation|Intent-to-treat|||participants|||Number
2829373|NCT00307125|Primary|Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies|Number of participants with 50% decrease in circulating anti-HLA antibodies at any time within the first 12 months post kidney transplant by LuminexTM Beads Method. Luminex assays for quantitation and detection of cytokine and signal transduction proteins. Presence of circulating antibodies is indicative of the transplant recipient's immune system responding to the transplanted organ as a foreign object or infection.|1 year post treatment initiation|Intent-to-treat|||participants|||Number
2829374|NCT00307125|Primary|During Screening Phase: Timing of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. Of these, 79 (12%) developed de novo HLA-antibodies (anti-HLA Ab). This outcome looks at the average length of time (interval) from post kidney transplant until development of alloantibody. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection|During screening window of 3-60 months post kidney transplant|Screening sample|||Months||Standard Deviation|Mean
2829375|NCT00307125|Primary|During Screening Phase: Incidence of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.|During screening window of 3-60 months post kidney transplant|Screening sample|||participants|||Number
2829376|NCT00307086|Primary|Overall Survival (OS)|Median overall survival after first peripheral blood stem cell transplant (PBSCT).|40 months post transplant|All evaluable participants|||months||95% Confidence Interval|Median
2829377|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|3 years||||Percentage of participants|||Number
2829378|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|2 years||||Percentage of participants|||Number
2829379|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|270 days||||Percentage of participants|||Number
2829380|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|180 days||||Percentage of participants|||Number
2829381|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|30 days||||Percentage of participants|||Number
2829382|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||3 years||||Percentage of participants|||Number
2829383|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||2 years||||Percentage of participants|||Number
2829384|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||1 year||||Percentage of participants|||Number
2829385|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||270 days||||Percentage of participants|||Number
2829386|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||180 days||||Percentage of participants|||Number
2829387|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||30 days||||Percentage of participants|||Number
2829388|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-1123 days||||Percentage of participants|||Number
2829389|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-758 days||||Percentage of participants|||Number
2829390|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-393 days||||Percentage of participants|||Number
2829391|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|31-393 days||||Percentage of participants|||Number
2829392|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-30 days||||Percentage of participants|||Number
2829393|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-1123 days||||Percentage of participants|||Number
2829394|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-758 days||||Percentage of participants|||Number
2829395|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0 -393 days||||Percentage of participants|||Number
2829396|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|31-393 days||||Percentage of participants|||Number
2829397|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-30 days||||Percentage of participants|||Number
2829398|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||3 years||||Percentage of participants|||Number
2829399|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||2 years||||Percentage of participants|||Number
2829400|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||1 year||||Percentage of participants|||Number
2829401|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||270 days||||Percentage of participants|||Number
2829402|NCT00307047|Primary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|1 year||||Percentage of participants|||Number
2829403|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||180 days||||Percentage of participants|||Number
2829404|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||30 days||||Percentage of participants|||Number
2829405|NCT00307047|Secondary|All Cause Mortality||3 years||||Percentage of participants|||Number
2829406|NCT00307047|Secondary|All Cause Mortality||2 years||||Percentage of participants|||Number
2829407|NCT00307047|Secondary|All Cause Mortality||1 year||||Percentage of participants|||Number
2829408|NCT00307047|Secondary|All Cause Mortality||270 days||||Percentage of participants|||Number
2829409|NCT00307047|Secondary|All Cause Mortality||180 days||||Percentage of participants|||Number
2829410|NCT00307047|Secondary|All Cause Mortality||30 days||||Percentage of participants|||Number
2829411|NCT00307047|Secondary|All MI||3 years||||Percentage of participants|||Number
2829412|NCT00307047|Secondary|All MI||2 years||||Percentage of participants|||Number
2829413|NCT00307047|Secondary|All MI||1 year||||Percentage of participants|||Number
2829414|NCT00307047|Secondary|All MI||270 days||||Percentage of participants|||Number
2829415|NCT00307047|Secondary|All MI||180 days||||Percentage of participants|||Number
2829416|NCT00307047|Secondary|All Myocardial Infarction (MI)||30 days||||Percentage of participants|||Number
2829417|NCT00307047|Secondary|Acute Success (Clinical Procedure)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.|Acute: At time of index procedure|Clinical procedure success is computed per subject|||Percentage of success|||Number
2829511|NCT00306852|Secondary|Reoperations for Glaucoma|Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.|5 years||||participants|||Number
2829418|NCT00307047|Secondary|Acute Success (Clinical Device)|Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.|Acute: At time of index procedure|clinical device success is computed per lesion|||Percent of success|||Number
2829419|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|3 years||||Percentage of participants|||Number
2829420|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|2 years||||Percentage of participants|||Number
2829421|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|1 years||||Percentage of participants|||Number
2829422|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|270 days||||Percentage of participants|||Number
2829423|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|180 days||||Percentage of participants|||Number
2829424|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|30 days||||Percentage of participants|||Number
2829425|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years||||percentage of participants|||Number
2829426|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years||||percentage of participants|||Number
2829427|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year||||percentage of participants|||Number
2829428|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days||||percentage of participants|||Number
2829429|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days||||percentage of participants|||Number
2829430|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days||||percentage of participants|||Number
2829431|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years|ITT population.|||percentage of participants|||Number
2829432|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years|ITT population.|||percentage of participants|||Number
2829433|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year|ITT population.|||percentage of participants|||Number
2829434|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days|ITT population|||percentage of participants|||Number
2829436|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days|ITT population.|||percentage of participants|||Number
2829437|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|3 years|ITT, @ 3 years|||percentage of participants|||Number
2829438|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|2 years|ITT, @ 2 years|||percentage of participants|||Number
2829439|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|1 year|ITT, @ 1 yr|||percentage of participants|||Number
2829440|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|270 days||||percentage of participants|||Number
2829441|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|180 days||||percentage of participants|||Number
2829442|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|30 days||||percentage of participants|||Number
2829443|NCT00307034|Secondary|Number of Subjects With Serious Adverse Events|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the booster vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
2829444|NCT00307034|Secondary|Number of Subjects With Serious Adverse Events|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|During the primary vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
2829445|NCT00307034|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) post booster vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
2829446|NCT00307034|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) post-primary vaccination period, across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
2829447|NCT00307034|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C. Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.|During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
2829512|NCT00306852|Secondary|Visual Acuity|Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart|5 years|Participants who complete 5 years of follow-up|||Letters||Standard Deviation|Mean
2829513|NCT00306852|Primary|Rate of Complications|Complications associated with both surgical procedures|5 years||||participants|||Number
2829448|NCT00307034|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Across doses= across the 2 doses of the Synflorix™ vaccine in the Synflorix I group and across the 3 doses of the Synflorix™ vaccine in the Synflorix II group.|During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects (i.e. who had received at least one dose of study vaccine during the primary vaccination course or the booster dose).|||Subjects|||Number
2829449|NCT00307034|Secondary|Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies|Booster vaccine response to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN), defined as the appearance of antibodies in subjects who were seronegative (Pre-booster status S-) (i.e., with antibody concentrations < 5 EL.U/mL) just before booster dose, and at least two-fold increase of pre-vaccination antibody concentrations in those who were seropositive (Pre-booster status S+) (i.e., with antibody concentrations ≥ 5 EL.U/mL) just before booster dose.|One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Subjects|||Number
2829450|NCT00307034|Secondary|Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3)|Titers of antibodies are presented as geometric mean titers. Seroprotection status was defined as anti-polio types 1, 2 and 3 (Anti-polio 1, 2 and 3) antibody titers greater than or equal to (≥) the value of 8. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Titers||95% Confidence Interval|Geometric Mean
2829451|NCT00307034|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as milli international units per milliliter (mIU/mL). Seroprotection status was defined as anti-hepatitis B surface antigen (anti-HBs) antibody concentrations greater than or equal to (≥) the cut-off value of 10 mIU/mL. This outcome concerns results for the Primary and Booster Phases of the study and included only the subset of subjects who received Infanrix Hexa™ as the co-administered vaccine.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2829452|NCT00307034|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity status was defined as anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) the cut-off value of 5 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2829453|NCT00307034|Secondary|Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP)|Concentrations of antibodies are presented as geometric mean concentrations, expressed as micrograms per milliliter (μg/mL). Seroprotection status was defined as anti-polyribosyl ribitol phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) the cut-off values of 0.15 μg/mL and ≥ 1.0 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2829454|NCT00307034|Secondary|Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids|Concentrations of antibodies are presented as geometric mean concentrations, expressed as international units per milliliter (IU/mL). Seroprotection status was defined as anti-diphteria and anti-tetanus toxoid antibody concentrations greater than or equal to (≥) the value of 0.1 IU/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2829455|NCT00307034|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).Seropositivity status was defined as Anti-PD antibody concentrations greater than or equal to (≥) the value of 100 EL.U/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2829514|NCT00306852|Primary|Change in Intraocular Pressure|The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.|Baseline to 5 years|Participants who completed 5 years of follow-up|||mm Hg||Standard Deviation|Mean
2829456|NCT00307034|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophacocytic activity against pneumococcal serotypes greater than or egual to (≥) the value of 8. The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Titers||95% Confidence Interval|Geometric Mean
2829457|NCT00307034|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. This outcome concerns results for the Primary and Booster Phases of the study.|One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2829458|NCT00307034|Secondary|Number of Seroprotected Subjects Against Pneumococcal Serotypes|A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs).|One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Subjects|||Number
2829459|NCT00307034|Primary|Number of Seroprotected Subjects Against Pneumococcal Serotypes|A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.|One month post-dose 2 (Month 3) administration of Synflorix™ vaccine|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity concerning data were available.|||Subjects|||Number
2829460|NCT00306995|Secondary|Seroconversion Factor (SCF) for Influenza A Subtype H9N2.|SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain.|At Days 189 and 365|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||fold increase||95% Confidence Interval|Geometric Mean
2829461|NCT00306995|Secondary|Number of Subjects With Antibody Persistence|Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.|At Days 189 and 365|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829462|NCT00306995|Secondary|Number of Subjects With Any SAEs|A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame.|Up to 30-day post Dose 3 (Days 365-394)|The analysis was performed on the Total Vaccinated Cohort (TVc) of Subset 2, which included all vaccinated subjects (for whom the diary card was available).|||Participants|||Count of Participants
2829463|NCT00306995|Secondary|Number of Subjects With SAEs|A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).|Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)|The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).|||Participants|||Count of Participants
2829464|NCT00306995|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)|The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).|||Participants|||Count of Participants
2829465|NCT00306995|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.|During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)|The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).|||Participants|||Count of Participants
2829466|NCT00306995|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.|During the 4-Days (Day 0-3) across doses 1 and 2|The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).|||Participants|||Count of Participants
2829467|NCT00306995|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.|During the 4-days post Dose 2 (Days 21-24)|The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).|||Participants|||Count of Participants
2829468|NCT00306995|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.|During the 4-days (Day 0-3) post Dose 1|The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).|||Participants|||Count of Participants
2829469|NCT00306995|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).|During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)|The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).|||Participants|||Count of Participants
2829470|NCT00306995|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).|During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses|The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).|||Participants|||Count of Participants
2829471|NCT00306995|Primary|Number of Subjects With Seroprotection Power Against H9N2|Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.|At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829472|NCT00306995|Primary|Number of Subjects With Seroprotection Power Against H9N2|Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.|At Day 21 post Dose 2 (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829473|NCT00306995|Primary|Number of Seroprotected Subjects Against H9N2|Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.|At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829474|NCT00306995|Primary|Number of Seroprotected Subjects Against H9N2|Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.|At Day 21 post Dose 2 (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2829631|NCT00305578|Primary|Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)|Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.|8 weeks||||units on a scale||Standard Deviation|Mean
2829475|NCT00306995|Primary|Seroconversion Factor for Influenza A Subtype H9N2|Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.|At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Fold change||95% Confidence Interval|Number
2829476|NCT00306995|Primary|Seroconversion Factor for Influenza A Subtype H9N2|Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.|At Day 21 post Dose 2 (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2829477|NCT00306995|Primary|Number of Seroconverted Subjects Against Influenza A Subtype H9N2|Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer|At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829478|NCT00306995|Primary|Number of Seroconverted Subjects Against Influenza A Subtype H9N2|Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer|At Day 21 post Dose 2 (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2829479|NCT00306995|Primary|Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)|Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Titers||95% Confidence Interval|Geometric Mean
2829480|NCT00306995|Primary|Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)|Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 21 post Dose 2 (Day 42)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2829481|NCT00306995|Secondary|Cytokine-positive CD8 T-cells Frequency|Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.|At Days 10, 21 and 42 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2829482|NCT00306995|Secondary|Frequency of Antigen-specific CD8 T-cells|Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).|At Days 0, 10, 21 and 42 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2829483|NCT00306995|Secondary|Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells|Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).|At Days 0, 10, 21 and 42 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2829484|NCT00306995|Secondary|Cytokine-positive CD4 T-cells Frequency|Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.|At Days 10, 21 and 42 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2829485|NCT00306995|Secondary|Frequency of Antigen-specific CD4 T-cells|Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).|At Days 0, 10, 21 and 42 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
2829486|NCT00306995|Secondary|Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells|Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).|At Days 0, 10, 21 and 42 post vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||T-cells/million cells||Inter-Quartile Range|Median
2829487|NCT00306995|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).|From Day 0 to Day 51|The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.|||Participants|||Count of Participants
2829488|NCT00306995|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-days (Day 0-30) post vaccination|The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.|||Participants|||Count of Participants
2829489|NCT00306995|Primary|Number of Subjects With Seroprotection Power Against H9N2|Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.|At Day 21 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829490|NCT00306995|Primary|Number of Subjects With Seroprotection Power Against H9N2|Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.|At Day 10 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.|||Participants|||Count of Participants
2829491|NCT00306995|Primary|Number of Seroprotected Subjects Against H9N2|Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.|At Day 21 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2829492|NCT00306995|Primary|Number of Seroprotected Subjects Against H9N2|Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.|At Day 10 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2829493|NCT00306995|Primary|Seroconversion Factor for Influenza A Subtype H9N2|Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.|At Day 21 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2829494|NCT00306995|Primary|Seroconversion Factor for Influenza A Subtype H9N2|Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.|At Day 10 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2829495|NCT00306995|Primary|Number of Seroconverted Subjects Against Influenza A Subtype H9N2|Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer|At Day 21 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2829686|NCT00305162|Secondary|Incidence of All Cause Mortality|(excluding STEMI)|randomization through 1 year after randomization|mITT (excluding STEMI), based on 1 year completers|||participants|||Number
2829496|NCT00306995|Primary|Number of Seroconverted Subjects Against Influenza A Subtype H9N2|Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer|At Day 10 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2829497|NCT00306995|Primary|Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)|Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 21 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2829498|NCT00306995|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)|Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).|At Day 10 post Dose 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2829499|NCT00306917|Primary|Harris Hip Score (HHS)|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.|Preoperative, 6, 12, 24, 36, 48, and 60 months|Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores.|||Units on a scale||Standard Deviation|Mean
2829500|NCT00306917|Secondary|Medical Imaging||postoperative, 6, 12, 24, 36, 48 and 60 months|||||||
2829501|NCT00306891|Secondary|Part B: Progression-free Survival (PFS)|"Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).~Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.~Progression (PD) Unequivocal progression of existing non-target lesions."|Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero.|||Days||Full Range|Median
2829502|NCT00306891|Secondary|Part B: Best Overall Response Rate (ORR)|"Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.~Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions"|Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.|ITT (intention-to-treat ) patients with baseline RECIST data|||Participants|||Number
2829503|NCT00306891|Secondary|Part A: Apparent Total Body Clearance (CL/F)|Apparent total body clearance of drug from plasma|Measurements were collected up to 168 hours (following single dosing).||||L/h||Full Range|Geometric Mean
2829504|NCT00306891|Secondary|Part A: Terminal Phase Half-life (t1/2λz)|Terminal phase half-life|Measurements were collected up to 168 hours (following single dosing).||||hr||Full Range|Geometric Mean
2829505|NCT00306891|Secondary|Part A: Time to Peak or Maximum Concentration (Tmax)|Time to reach peak or maximum concentration or maximum response|Measurements were collected up to 168 hours (following single dosing).||||hr||Full Range|Geometric Mean
2829506|NCT00306891|Secondary|Part A: AUC (0-t)|Area under the curve from time 0 to the last measureable time point|Measurements were collected up to 168 hours (following single dosing).||||ng*h/mL||Full Range|Geometric Mean
2829507|NCT00306891|Primary|Part A: Maximum Plasma (Peak) Concentration (Cmax)|Maximum plasma drug concentration|Measurements were collected up to 168 hours (following single dosing).||||ng/mL||Full Range|Geometric Mean
2829508|NCT00306891|Primary|Part A: Area Under Plasma Concentration-time Curve (AUC)|Area under plasma concentration-time curve from zero to infinity|Measurements were collected up to 168 hours (following single dosing).||||ng*h/mL||Full Range|Geometric Mean
2829509|NCT00306852|Secondary|Failure Rate|Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.|5 years||||percentage of participants|||Number
2829510|NCT00306852|Secondary|Need for Supplemental Medical Therapy|The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years|5 years||||number of medications||Standard Deviation|Mean
2829515|NCT00306787|Secondary|Time to a Second Recurrence of Genital Herpes|"Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:~From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or~From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence."|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median.|||days||Inter-Quartile Range|Median
2829516|NCT00306787|Secondary|Number of Patients With a Second Recurrence of Genital Herpes|Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences.|||participants|||Number
2829517|NCT00306787|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.|72 hours after initiation of study medication up to Day 20|ITT population. If the resolution of any or all symptoms was not confirmed by a subsequent visit or diary entry, the time to resolution was censored at the time of the last diary entry. If a patient dropped out before any diary entries were created, the patient was assigned a censoring time of 0. n= number of patients with symptoms.|||hours||Inter-Quartile Range|Median
2829518|NCT00306787|Secondary|Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.|72 hours after initiation of study medication up to Day 20|ITT population. Median time was estimated by kaplan-Meier method by censoring the missing non-aborted times at last clinical observation. Patients with aborted lesions were assigned a time to healing of zero.|||days||Inter-Quartile Range|Median
2829519|NCT00306787|Secondary|Percentage of Participants With Aborted Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.|72 hours after initiation of study medication up to Day 20|ITT population. Patients who discontinued from the study before healing of non-aborted lesions was confirmed and patients who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were assumed to have non-aborted lesions in this analysis.|||Percentage of participants|||Number
2829520|NCT00306787|Primary|Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.|72 hours after initiation of study medication up to Day 20|Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment.|||days||Inter-Quartile Range|Median
2829521|NCT00306670|Primary|To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.|the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated|When 25 patients have completed the study.|2 patients with acquired hemophilia A: two patients were recruited, but the sponsor terminated the study before the patients started treatment|||Participants|||Count of Participants
2829522|NCT00306592|Primary|Number of Participants With Antibodies to Natalizumab|'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.|Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)|All participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody result after the first dose.|||participants|||Number
2829523|NCT00306592|Primary|Number of Participants With Hypersensitivity-related Adverse Events|For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.|Baseline through Week 48|Participants receiving at least 1 dose of study drug|||participants|||Number
2829687|NCT00305162|Secondary|Incidence of Stroke||randomization through 30 days after randomization|mITT (excluding STEMI), based on available data|||participants|||Number
2829524|NCT00306592|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)|AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.|Baseline through Week 48|Participants receiving at least 1 dose of study drug|||participants|||Number
2829525|NCT00306527|Primary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine|To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .|Day 1 to Day 7 postvaccination|This analysis was done on safety dataset|||Participants|||Number
2829526|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine.~Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer."|Day 22 postvaccination|This analysis was done on the immunogenicity subset.|||Percentages of subjects||95% Confidence Interval|Number
2829527|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.~European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly."|Day 22 postvaccination|This analysis was done on immunogenicity subset.|||Percentages of subjects||95% Confidence Interval|Number
2829528|NCT00306527|Secondary|Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.~The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.|||Ratio||95% Confidence Interval|Geometric Mean
2829529|NCT00306527|Secondary|Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs.~The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.|||Titers||95% Confidence Interval|Geometric Mean
2829530|NCT00306527|Secondary|Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study.|Up to 6 months postvaccination|This analysis was done on the safety dataset.|||Participants|||Number
2829531|NCT00306488|Secondary|The Change in Total Drusen Area From Baseline to Year 2.||2 years|||||||
2829532|NCT00306488|Secondary|The Change in the Number of Scotomatous Points Between Study and Fellow Eyes From Baseline to Year 2.|Scotomatous points are testing points on microperimetry examination that are centered on the macula and report a lack of retinal sensitivity within the range tested.|2 years|||||||
2829533|NCT00306488|Secondary|The Change in Contrast Sensitivity as Measured by the Pelli-Robson Chart From Baseline to Year 2.|The Pelli-Robson Chart is comprised of 10 groups of 3 large letters with levels of contrast ranging from 100% (black against white) to 1% (very light gray against white). Each eye is assigned a score based on the contrast of the last group in which two or three letters were correctly read. A score of 2 log units, which represents a normal sensitivity contrast, indicates that the eye was able to detect two of the three letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2).|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."|||Log Units|Participants|Standard Deviation|Mean
2829534|NCT00306488|Secondary|The Change in GA, as Measured on Stereoscopic Color Fundus Photography (CFP) From Baseline to Year 2.|GA was also measured using Stereoscopic Color Fundus Photography (CFP), which produces color images of the inside of the eye.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."|||mm^2|Participants|Standard Deviation|Mean
2829535|NCT00306488|Secondary|The Change in Geographic Atrophy (GA), as Measured on Fundus Autofluorescence Imaging Using a Confocal Scanning Ophthalmoscope (HRA FAF) From Baseline to Year 2.|Geographic Atrophy (GA), or the death of photoreceptors and surrounding cells in the retina, is a common condition in patients with Age-Related Macular Degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The amount of GA is measured from images produced via a non-invasive technique called Fundus Autofluorescence Imaging, which uses a Confocal Scanning Ophthalmoscope to detect the naturally-fluorescing lipofuscin (the waste that is left behind by dead photoreceptors and digested by surrounding cells) that is prevalent at the border of the lesion.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."|||mm^2|Participants|Standard Deviation|Mean
2829536|NCT00306488|Primary|The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|2 years|"Data collected from the 10 participants that completed the 24-month follow-up visit were analyzed.~Ten study eyes and 10 fellow eyes were analyzed."|||ETDRS Letters|Participants|Standard Deviation|Mean
2829537|NCT00306384|Secondary|Percentage of Participants With a Clinical Response|"Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit:~HbA1c ≤6.5%;~HbA1c ≤7.0%."|Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.|Safety set.|||percentage of participants|||Number
2829538|NCT00306384|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set for whom data was available.|||kg||Standard Deviation|Mean
2829539|NCT00306384|Secondary|Change From Baseline in C-peptide Level|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002 are not included.|||ng/mL||Standard Deviation|Mean
2829540|NCT00306384|Secondary|Change From Baseline in Insulin Level|The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Does not include patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002.|||μIU/mL||Standard Deviation|Mean
2829541|NCT00306384|Secondary|Change From Baseline in Proinsulin Level|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.~Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level."|Baseline and Year 4|Safety set where data were available.|||pmol/L||Standard Deviation|Mean
2829542|NCT00306384|Secondary|Percentage of Participants With Marked Hyperglycemia|"Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L).~The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window)."|Randomization up to 4 years.|Safety set where data were available.|||percentage of participants|||Number
2829543|NCT00306384|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data were available.|||mg/dL||Standard Deviation|Mean
2829544|NCT00306384|Secondary|Change From Baseline Over Time in Glycosylated Hemoglobin|The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.|Safety set where data were available.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2829545|NCT00306384|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.|4 years|Safety set|||percentage of participants|||Number
2829546|NCT00306293|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. No SAEs were reported in this study.|Up to 148 days|Intent to treat exposed population comprised of all participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2829547|NCT00306293|Secondary|Median Time to First Genital Herpes Recurrence (Days)|Time to first genital herpes recurrence was evaluated using Kaplan-Meier estimates of investigator-confirmed genital herpes recurrences censoring the data from participants who prematurely discontinue the study at the time of discontinuation.|Up to Day 68|First Period Efficacy Population included participants in the Intent to Treat Exposed Population and was used for efficacy analyses restricted to the First Treatment Period.|||Days||Full Range|Median
2829548|NCT00306293|Secondary|Percentage of Participants With at Least One Genital Herpes Recurrence|The proportion of participants with at least one genital herpes recurrence was defined as the number of participants with at least one investigator-confirmed genital herpes recurrence divided by the total number of participants with at least one clinic visit in the treatment period.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percetage of participants|||Number
2829628|NCT00305604|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829549|NCT00306293|Secondary|Percentage of Participants With no Shedding|The proportion of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data in the Treatment Period. Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Mean percent of days with no shedding was reported for each treatment group.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percentage of participants|||Number
2829550|NCT00306293|Secondary|Mean Percent Days Clinical Shedding (Presence of Genital Lesions)|The percent of days with clinical HSV-2 shedding was defined as the percent of all days with PCR data for which clinical HSV-2 shedding was detected (shedding in the presence of a genital lesion). Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Mean percent of days with clinical HSV-2 shedding was reported for each treatment group.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percentage of Days||Standard Deviation|Mean
2829551|NCT00306293|Secondary|Mean Percent Days Subclinical Shedding (no Genital Lesions Present)|The percent of days with subclinical HSV-2 shedding was defined as the percent of all days with PCR data for which subclinical HSV-2 shedding was detected (shedding in the absence of a genital lesion). Mean percent of days with subclinical HSV-2 shedding was reported for each treatment group. Each participant's study day was classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits.|Up to 60 days in each treatment period (Up to 148 days)|Intent-to-Treat Crossover|||Percentage of days||Standard Deviation|Mean
2829552|NCT00306293|Primary|Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2)|Each participant's study day were classified as either 'shedding' (positive HSV-2 result), 'no shedding' (negative HSV-2 result), or 'unknown' (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab are positive, the day was classified as 'shedding'. Study shedding day was classified as either 'clinical' (investigator-confirmed presence of genital lesions) or 'subclinical' (no genital lesions) by the investigator during recurrence visits. Percent of days with HSV-2 shedding was defined for each participant as the percent of days with PCR data for which HSV-2 shedding was detected by a positive PCR result, i.e., the number of days with HSV-2 PCR shedding divided by total number of days with PCR data, multiplied by 100. Sum of the percent clinical and nonclinical shedding days was reported as total shedding. Mean percent of days with HSV-2 shedding was reported for each treatment group.|Up to 60 days in each treatment period (Up to 148 days)|Intent to Treat Crossover population comprised of all participants in the Intent to Treat population who had at least one PCR swabbing result in each Treatment Period. Intent to Treat population comprised of all participants who received at least one dose of investigational product.|||Percent of days||Standard Deviation|Mean
2829553|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829554|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829555|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML|BCR-ABL = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829556|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN-8.0 mg/dL, GR2=<8.0-7.0 mg/dL, GR3=<7.0-6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN-1.2 mg/dL, GR2=<1.2-0.9 mg/dL, GR3=<0.9-0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN - 2.5 mg/dL, GR2=<2.5 - 2.0 mg/dL, GR3=<2.0 - 1.0 mg/dL, GR4=<1.0 mg/dL.|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
2829557|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.~ULN=upper limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
2829688|NCT00305162|Secondary|Incidence of IDR||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
2829558|NCT00306202|Other Pre-specified|Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. White Blood Cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.~LLN=lower limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
2829559|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML|BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829560|NCT00306202|Secondary|Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group|"Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment.~y=years"|4 hours after oral dose|"All treated participants with CSF samples available. n=number of PK parameters included.~Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||ng/mL||Standard Deviation|Mean
2829561|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2829562|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||hour||Full Range|Median
2829563|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2829564|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||hour||Standard Deviation|Mean
2829565|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2829566|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2829567|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||hour||Full Range|Median
2829568|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2829569|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
2829570|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-T] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
2829571|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||ng/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
2829572|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||hours||Geometric Coefficient of Variation|Geometric Mean
2829573|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."|||hours||Full Range|Median
2829574|NCT00306202|Secondary|Overall Survival (OS)|Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method.|From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy. Participants lost to followup were censored on the last date the participant was known to be alive.|||months||95% Confidence Interval|Median
2829575|NCT00306202|Secondary|Progression Free Survival (PFS)|"Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator.~Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment.~The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley."|From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|"All treated participants: Participants who received at least 1 dose of study therapy.~If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported."|||months||95% Confidence Interval|Median
2829576|NCT00306202|Secondary|Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay.~MMR: Ratio of the BCR-ABL to ABL <10^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL <10^-3 on the international scale in participants with p210 variant.~BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829577|NCT00306202|Secondary|Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML)|"Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay.~Major molecular response (MMR): Ratio of the BCR-ABL to ABL <10^-3 or 0.1% on the international scale.~Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is <10^-4.5 or 0.00316% on the international scale.~Confirmed MMR or CMR = Criteria met again >6 weeks. BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829578|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)|"A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.~Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR).~Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m^2.|||percentage of participants||95% Confidence Interval|Number
2829579|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)|"A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.~HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR.~The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m^2.|||percentage of participants||95% Confidence Interval|Number
2829580|NCT00306202|Secondary|Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3).~The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months).|Treated participants with CHR in strata 1 and 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.|||months||95% Confidence Interval|Median
2829581|NCT00306202|Secondary|Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed.~MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months).|All treated participants with MaHR in stratum 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.|||months||95% Confidence Interval|Median
2829582|NCT00306202|Secondary|Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval.~Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3.~Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).|All treated participants with CHR in strata 1 and 2/3.|||days||95% Confidence Interval|Median
2829583|NCT00306202|Secondary|Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)|"Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval.~MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days).|Treated participants with MaHR in stratum 2/3.|||days||95% Confidence Interval|Median
2829584|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)|HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829629|NCT00305604|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829585|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM.~Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829586|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)|"HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR):~WBC in PB: <10,000/mm^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) <5%; Basophils in PB: <5%; Platelet count (untransfused): <450,000/mm^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly.~Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829587|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks|"Defined as participants having as best response a CHR or CHRp.~Criteria:~CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).~CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm^3 ≤platelet <100,000/mm^3 and /or 500/mm^3 ≤ANC ≤1000/mm^3."|After completion of Week 6 and 24 (measured at weeks 7 and 25)|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829588|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)|"Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp).~Criteria:~CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).~CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm^3 ≤platelet <100,000/mm^3 & /or 500/mm^3 ≤ANC ≤1000/mm^3."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829589|NCT00306202|Secondary|Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]|"Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best response was CCyR).~CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.|||months||95% Confidence Interval|Median
2829590|NCT00306202|Secondary|Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])|"Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best responses were MCyR and CCyR respectively).~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.|||months||95% Confidence Interval|Median
2829591|NCT00306202|Secondary|Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method.|Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days).|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders.|||days||95% Confidence Interval|Median
2829630|NCT00305604|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2829689|NCT00305162|Secondary|Incidence of MI||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
2829592|NCT00306202|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||percentage of participants||95% Confidence Interval|Number
2829593|NCT00306202|Secondary|Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample.~Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:>65%-95% Ph+ cells in metaphase in BM. No CyR:>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases [%Ph+ <100%])."|Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|"All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy.~Stratum 2/3 dasatinib 80 mg/m^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study."|||participants|||Number
2829594|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|After completion of Week 12 and 24 (measured at Weeks 13 and 25)|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829595|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR).~CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829596|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
2829597|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN-8.0 mg/dL, GR2=<8.0-7.0 mg/dL, GR3=<7.0-6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN-1.2 mg/dL, GR2=<1.2-0.9 mg/dL, GR3=<0.9-0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN - 2.5 mg/dL, GR2=<2.5 - 2.0 mg/dL, GR3=<2.0 - 1.0 mg/dL, GR4=<1.0 mg/dL.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
2829598|NCT00306202|Secondary|Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. ANC: GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.|Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.|||participants|||Number
2829599|NCT00306202|Secondary|Number of Participants With Dose-limiting Toxicity (DLT)|"DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:-~Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days~GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution~Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829690|NCT00305162|Secondary|Incidence of All-cause Mortality||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
2829600|NCT00306202|Secondary|Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.|"AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization.~Grade 3 = Severe; Grade 4 = Life-threatening or disabling."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.|||participants|||Number
2829601|NCT00306202|Primary|Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia|The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.|From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy|||mg/m^2 QD|||Number
2829602|NCT00306189|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|All subjects who received >= 1 dose of investigational product and have a baseline and >= 1 post baseline measurement at the lumbar spine.|||Percent Change from Baseline||95% Confidence Interval|Mean
2829603|NCT00306163|Secondary|Safety and Tolerability||5 weeks|||||||
2829604|NCT00306163|Secondary|Δ (FVC/SVC) at PC20 (AMP)|Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.|Baseline and 5 weeks|||||||
2829605|NCT00306163|Primary|PC20 AMP (Post-treatment Compared to Baseline)|Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron|Baseline and 5 weeks|The analyses on treatment effects were performed on all subjects who reached a PC20<640mg/mL.|||Logarithm (mg/mL)||Standard Deviation|Mean
2829606|NCT00305942|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.|||Months||95% Confidence Interval|Median
2829607|NCT00305942|Secondary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.|18 months|All patients were assessed for time to progression.|||Months||95% Confidence Interval|Median
2829608|NCT00305942|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.~The final response category assigned represented the best response obtained during treatment."|18 months|All patients were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2829609|NCT00305877|Secondary|Two-year Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).|Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years|Eligible and treated patients.|||Proportion of patients||95% Confidence Interval|Number
2829610|NCT00305877|Secondary|Two-year Overall Survival Rate|Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.|Assessed every 3 months for 2 years|Eligible and treated patients are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2829611|NCT00305877|Primary|Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy|"Specific toxicities to be monitored pursuant to the primary endpoint include:~Any grade 5 toxicities~Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension~Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis~ECOG performance status decline by 2 or greater for >24 hours~Weight loss >10%"|Every 2 weeks while on treatment and for 30 days after the end of treatment|All treated patients were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2829612|NCT00305864|Secondary|Progression-free Survival (Phase II)|Progression will be defined as a > 25% increase in tumor area. Progression-free survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.|From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months.|All eligible patients|||months||95% Confidence Interval|Median
2829613|NCT00305864|Primary|Median Overall Survival (Phase II)|Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months|All eligible patients.|||Months||95% Confidence Interval|Median
2829691|NCT00305162|Secondary|Incidence of All-cause Mortality or MI|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
2829614|NCT00305864|Primary|Maximum Tolerated Dose of MGd (Phase I)|"Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the maximum tolerated dose (MTD). The MTD would be used for the Phase II arm.~Rating scale: 0 = not the MTD, 1 = MTD"|From start of radiation therapy to 90 days,|Eligible patients who received protocol treatment.|||units on a scale|||Number
2829615|NCT00305773|Other Pre-specified|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was defined as the time from registration to until the date of treatment discontinuation of any reason. Patients receiving treatment at the time of analysis were considered censored. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Duration of treatment (up to 17 cycles)||||days||90% Confidence Interval|Median
2829616|NCT00305773|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Duration of study (up to 2 years)||||participants|||Number
2829617|NCT00305773|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 2 years)||||days||95% Confidence Interval|Median
2829618|NCT00305773|Secondary|Time to Progression (TTP)|Time to Progression (TTP) for each patient will be calculated as the number of days from date of registration to either date when disease progression was documented or date of last evaluation without disease progression. The TTP distribution will be estimated using the method of Kaplan-Meier|Duration of study (up to 2 years)|This data was not (and will never be) analyzed. In place of this outcome, time to treatment failure, analyzed and reported as a secondary outcome.||||||
2829619|NCT00305773|Primary|Confirmed Complete Response (CR) Rate|"The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants.~According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC > 1500/mL, platelets > 100000/mL, no circulating blasts, bone marrow cellularity >20% (biopsy), trilineage maturation, < 5% bone marrow blasts, no auer rods and no extramedullary disease."|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2829620|NCT00305760|Primary|Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population||7 months||||Adverse Events|||Number
2829621|NCT00305695|Primary|Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip|To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months|18 months|Eligible and Treated patients|||g/cm2||Full Range|Mean
2829622|NCT00305695|Primary|Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip|To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months|18 months|Eligible and Treated patients|||g/cm2||Full Range|Mean
2829623|NCT00305695|Primary|Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months|To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).|18 months|Eligible and Treated Patients|||g/cm2||Full Range|Mean
2829624|NCT00305695|Primary|Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months|To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).|9 Months|Eligible and Treated Patients|||g/cm2||Full Range|Mean
2829625|NCT00305643|Secondary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.|A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.|At 16 Weeks|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.||||||
2829626|NCT00305643|Primary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.|The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.|At 16 Weeks, with evaluations and blood test every 3 weeks.|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.||||||
2829627|NCT00305604|Secondary|Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week|Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.|Week 1|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose.|||mg/dL||95% Confidence Interval|Least Squares Mean
2829692|NCT00305162|Secondary|Incidence of All-cause Mortality, MI or IDR|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers|||participants|||Number
2829632|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
2829633|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
2829634|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
2829635|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean change at week 22"|From baseline to Study Week 22||||units on a scale||Standard Deviation|Mean
2829636|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
2829637|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
2829638|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
2829639|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean change at week 22"|From baseline to Study Week 22||||units on a scale||Standard Deviation|Mean
2829640|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
2829641|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
2829642|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
2829643|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean change at week 22"|From baseline to Study Week 22||||units on a scale||Standard Deviation|Mean
2829644|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean percent change at week 50"|From baseline to Study Week 50||||mean percent change||Standard Deviation|Mean
2829645|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean change at week 50"|From baseline to Study Week 50||||units on a scale||Standard Deviation|Mean
2829646|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean percent change at week 22"|From baseline to Study Week 22||||mean percent change||Standard Deviation|Mean
2829647|NCT00305565|Post-Hoc|Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline MADRS score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior ECT history, total number of adequate drug trials and prior medication regimen).~The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers|||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
2829648|NCT00305565|Post-Hoc|Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline IDS-C score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior electroconvulsive therapy (ECT) history, total number of adequate drug trials and prior medication regimen).~The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers|||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
2829649|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50||||percentage of participants|||Number
2829650|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
2829651|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22||||percentage of participants|||Number
2829652|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
2829653|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)~In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 50||||percentage of participants|||Number
2829654|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)~In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 22||||percentage of participants|||Number
2829655|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of remitters at week 50. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 50||||percentage of participants|||Number
2829656|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the MADRS to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From Baseline to Study Week 50||||percentage of participants|||Number
2829657|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
2829658|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of remitters at week 22. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 22||||percentage of participants|||Number
2829659|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
2829660|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 50||||percentage of participants|||Number
2829661|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
2829662|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 22||||percentage of participants|||Number
2829663|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
2829664|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50||||percentage of participants|||Number
2829665|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the IDS-C to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From baseline to Study Week 50||||percentage of participants|||Number
2829666|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50||||percentage of participants|||Number
2829667|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22||||percentage of participants|||Number
2829668|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22||||percentage of participants|||Number
2829669|NCT00305565|Primary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.|From Baseline to Study Week 22||||units on a scale|Participants|Standard Error|Least Squares Mean
2829670|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy.|||Vss/F (L)||Standard Deviation|Mean
2829671|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy. The results are based on 148, 122 and 140 plasma-concentration records from patients in the 250 mg, 250 mg + LD and 500 mg treatment arms respectively.|||L/h||Standard Deviation|Mean
2829672|NCT00305448|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.||||percentage of participants|||Number
2829673|NCT00305448|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.|||||||
2829674|NCT00305448|Secondary|Time to Progression (TTP)|Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.|every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)||||days||Full Range|Median
2829675|NCT00305448|Primary|Objective Response Rate (ORR)|"An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.~Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization"|baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)||||percentage of participants|||Number
2829676|NCT00305344|Primary|Children With T1D Underwent a Single Autologous UCB Transfusion|All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insuln production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes|Baseline to Year 2|All participants received their own autologous umbilical cord blood (UCB)|||ng /ml /120 min||Inter-Quartile Range|Median
2829677|NCT00305253|Secondary|Emergency Hysterectomy|incidence of emergency hysterectomy for cases of uterine atony|within 72 hours of study enrollment|Data on emergency hysterectomy are only for women with diagnosis of uterine atony.|||participants|||Number
2829678|NCT00305253|Secondary|Blood Loss Due to Obstetric Hemorrhage|cumulative blood loss measured hourly upon study admission by calibrated blood collection drape|within 72 hours of study enrollment|Blood loss information was missing on some patients.|||mL||Standard Deviation|Mean
2829679|NCT00305253|Primary|Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)||from early pregnancy to within 3 weeks postpartum|All patients enrolled in the study were used in this analysis.|||participants|||Number
2829680|NCT00305227|Secondary|Incidence of Vaginal Discharge||4 mo|||||||
2829681|NCT00305227|Primary|Incidence of Urinary Tract Infection|Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.|10 weeks|The reported analysis was by intention to treat. All study participants were used, except for 4 participants in whom the major outcome measure was unevaluable.|||participants|||Number
2829682|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)|excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
2829683|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
2829684|NCT00305162|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
2829685|NCT00305162|Secondary|Incidence of GUSTO Severe / Life-threatening Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)|||participants|||Number
2829693|NCT00305162|Secondary|Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI|(a patient could have multiple procedural events)|during index PCI|mITT (excluding STEMI) and based on available data|||participants|||Number
2829694|NCT00305162|Secondary|Incidence of Stroke|"Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:~primary hemorrhagic - stroke with focal collections of intracranial blood~ischemic cerebral infarction - stroke without focal collections of intracranial blood~infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding~uncertain - no imaging or autopsy data are available."|randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
2829695|NCT00305162|Secondary|Individual Incidence of IDR||randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
2829696|NCT00305162|Secondary|Individual Incidence of All-cause Mortality||randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
2829697|NCT00305162|Secondary|Incidence of All-cause Mortality and MI|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
2829698|NCT00305162|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)|||participants|||Number
2829699|NCT00305110|Post-Hoc|Pain Intensity Assessed Over 2-hour Time Frame|"Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain possible). Participants are asked to rate their pain periodically over a 2 hour time period following infusion of the medication."|baseline up to 120 minutes after post infusion||||units on a scale||Inter-Quartile Range|Median
2829700|NCT00305110|Secondary|Oxygen Saturation Measured Over 2-hour Time Frame|blood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused|baseline to 120 minutes post infusion||||% oxygen saturation||Inter-Quartile Range|Median
2829701|NCT00305110|Secondary|Oxygen Desaturation Measured Over 2-hour Time Frame|blood oxygen saturation less than 95% is considered oxygen desaturation. Blood oxygen saturation is normally above 95%. Oxygen desaturation of less than 90% is dangerous because there is less oxygen throughout the body for cellular energy. Prolonged or severe blood oxygen desaturation can result in injury or death.|immediately after infusion, up to 120 minutes post infusion||||participants||95% Confidence Interval|Number
2829702|NCT00305110|Secondary|Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg|Normal systolic blood pressure is approximately 120 mmHg. A low systolic blood pressure indicates blood, and therefore oxygen, are not being distributed around the body properly. This leads to a decreased amount of oxygen for the body to use and can result in injury or death if prolonged or severe.|Immediately after infusion, up to 120 minutes post infusion||||Participants|||Count of Participants
2829703|NCT00305110|Secondary|Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute|Normal respiratory rate ranges from 12 to 20 breaths per minute. The decreased respiration results in a decreased amount of oxygen entering the body and therefore low amount of oxygen supplied to the brain. Prolonged oxygen deprivation can result in injury or death. Respiratory rates lower than 12 breaths per minute is a sign of distress. Number of participants experiencing a respiratory rate lower than 12 breaths per minute is measured.|immediately after infusion, up to 120 minutes post infusion||||Participants|||Count of Participants
2829704|NCT00305110|Primary|Number of Participants Requiring Naloxone|Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed.|immediately after infusion, up to 120 minutes post infusion||||Participants|||Count of Participants
2829705|NCT00305084|Secondary|Signs of Anticancer Activity by Standard Imaging or Clinically; When Possible Tumor Response Will be Documented According to RECIST Criteria|Response to treatment was assessed on a set of target lesions(TL) chosen before the 1st treatment administration, the list of TL must be reported on the initial measurement form before the start of treatment. Lesions had to have clearly defined borders and initially were measured in at least one dimension, and had to be repeated at each evaluation of the disease by the same method. Sum of the longest diameter (LD) was calculated as the baseline sum LD Complete Response(CR): Disappearance of all TL Partial Response(PR): At least a 30% decrease in the sum of the LD of TL, taking as reference the base line sum LD Progressive Disease(PD): At least a 20% increase in the sum of LD of TL, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|after the first 2 cycles(Follow-up 2) of treatment and then every 2 cycles (Follow-up 4,6..). In case of detection of a complete or partial response, a confirmation assessment must be performed ≥ 4 weeks after the first documentation of the response.|disease progression or until the start of another treatment|||participants|||Number
2829706|NCT00305084|Secondary|To Evaluate Phenotype Analysis and Adaptative Immune Response||during the study|No analysis was performed. No biopsy was preformed.||||||
2829747|NCT00304070|Secondary|Frequency of Tumor Spillage at the Time of Tumor Resection|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.|Up to one year or while on protocol therapy, whichever is less||||Participants|||Count of Participants
2829707|NCT00305084|Secondary|sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Eav)|Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||ng/mL||Standard Deviation|Mean
2829708|NCT00305084|Secondary|sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (ARC)|Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||ng⋅h/mL||Standard Deviation|Mean
2829709|NCT00305084|Secondary|sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Tmax)|Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||h||Standard Deviation|Mean
2829710|NCT00305084|Secondary|sTNFRs and Anti-NGR-hTNF Antibody Plasma Levels (Emax)|Pharmacodynamic calculations for sTNF-R1 and sTNF-R2 were performed on the plasma concentrations from which the baseline concentrations were subtracted (i.e. on positive and negative values). At all doses, Emax, i.e. the maximal stimulatory effect, and tmax were estimated as the coordinates of the highest point of the plasma profile (y, x axis, respectively)|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacodynamic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||ng/mL||Standard Deviation|Mean
2829711|NCT00305084|Secondary|Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (AUC0-t(Last))|Pharmacokinetic profiles of NGR-hTNF and doxorubicin was conducted in 4 sequential cohorts of patients (Three patients per each cohort were planned). The first 3 patients of the first cohort were treated with 0.2 μg/m2 of NGR-hTNF in combination with a suboptimal dose (minus 20%) of doxorubicin (60 mg/m2).Following 4 cohorts were treated with escalating dose of NGR-hTNF (0.2, 0.4, 0.8 and 1.6 μg/m2) in combination with a standard dose of doxorubicin (75 mg/m2):|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacokinetic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||pg⋅h/mL||Standard Deviation|Mean
2829712|NCT00305084|Secondary|Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Tmax)|Pharmacokinetic profiles of NGR-hTNF and doxorubicin was conducted in 4 sequential cohorts of patients (Three patients per each cohort were planned). The first 3 patients of the first cohort were treated with 0.2 μg/m2 of NGR-hTNF in combination with a suboptimal dose (minus 20%) of doxorubicin (60 mg/m2).Following 4 cohorts were treated with escalating dose of NGR-hTNF (0.2, 0.4, 0.8 and 1.6 μg/m2) in combination with a standard dose of doxorubicin (75 mg/m2):|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacokinetic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||h||Standard Deviation|Mean
2829713|NCT00305084|Secondary|Pharmacokinetic Profiles of NGR-hTNF Administrated in Combination With Doxorubicin (Cmax)|Pharmacokinetic profiles of NGR-hTNF and doxorubicin was conducted in 4 sequential cohorts of patients (Three patients per each cohort were planned). The first 3 patients of the first cohort were treated with 0.2 μg/m2 of NGR-hTNF in combination with a suboptimal dose (minus 20%) of doxorubicin (60 mg/m2).Following 4 cohorts were treated with escalating dose of NGR-hTNF (0.2, 0.4, 0.8 and 1.6 μg/m2) in combination with a standard dose of doxorubicin (75 mg/m2):|prior to infusion and 15', 30', 60', 90', 120', 134' [1 minute before the end of doxorubicin administration], 180', 240', 360' minutes|Pharmacokinetic of NGR-hTNF was conducted in 5 sequential cohorts of patients, 3 patients per each cohort were planned). All the patients treated on Cycle 1 were still in the study on Cycle2. On Cycle3 twelve out of fifteen patients were still in the study. Subjects no more included in the study were 1 patient in cohort 1 and 2 patients in cohort 5|||pg/mL||Standard Deviation|Mean
2829745|NCT00304083|Secondary|Response of Plexiform Neurofibroma to Neoadjuvant Chemotherapy Using Volumetric MRI Analysis|Evaluate the response of plexiformneurofibroma (if present) to neoadjuvant chemotherapy using WHO criteria and volumetric MRI analysis as a tool for response assessment|After 4 Cycles (1 cycle=21 days)|MRI imaging of the MPNST and plexiform neurofibroma component was not sufficient to allow for volumetric analysis over time. Reasons include differences in imaging technique over time and incomplete coverage of the entire tumor.||||||
2829714|NCT00305084|Primary|Number of Adverse Events From Escalating Doses of NGR-hTNF in Combination With a Fixed Dose of Doxorubicin|An Adverse Event (AE) is any untoward medical occurrence or experience in a patient or clinical investigation subject treated administered a pharmaceutical product and which does not necessarily have to have a casual relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Through study completion, an average of 1 year||||Adverse event|||Number
2829715|NCT00305058|Secondary|Number of Participants Satisfied With Pain Medication|"Number of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair."|30 minutes after medication infused||||Participants|||Count of Participants
2829716|NCT00305058|Secondary|Number of Participants With Pain Relief|Pain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused.|30 minutes after medication infused||||Participants|||Count of Participants
2829717|NCT00305058|Secondary|Number of Participants With a Change in Pain Score|Pain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score.|Baseline to 30 minutes after medication infused||||Participants|||Count of Participants
2829718|NCT00305058|Primary|Change in Pain Intensity|Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused|Baseline to 30 minutes after medication infused||||units on a scale||Standard Deviation|Mean
2829719|NCT00304954|Secondary|Changes in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) From Baseline to 24 Weeks||Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7||||Microns|||Number
2829720|NCT00304954|Secondary|Changes in Best-corrected Visual Acuity (BCVA) as Measured by the Standard Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol From Baseline to 24 Weeks|"The values in the table represent the denominator for the visual acuity in feet. A value of 20 represents normal 20/20 vision while increasing values for the denominator represent worsening vision."|Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7||||Feet|||Number
2829721|NCT00304954|Primary|Monthly Rates of Anti-VEGF (Vascular Endothelial Growth Factor) Injections||24 Weeks||||Injections per Month||Full Range|Median
2829722|NCT00304915|Primary|Percentage of Participants With Depression Treatment Response|Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.|6 months|intent to treat analysis|||percent response|||Number
2829723|NCT00304746|Primary|21-item Hamilton Depression Rating Scale Score (HAM-D)|The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).|9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.|||units on a scale||Standard Deviation|Mean
2829724|NCT00304746|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).|9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.|||units on a scale||Standard Deviation|Mean
2829725|NCT00304707|Primary|Smoking Abstinence|The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.|week 7, week 11 and week 24 after scheduled quit day||||participants|||Number
2829726|NCT00304512|Secondary|α-Gal A Activity In Leukocytes At Baseline, Week 12, And Week 48|Leukocytes were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hr) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.|Baseline, Week 12 (end of treatment period), Week 48 (end of extension period)|PD Population: all participants who received study drug and had at least 1 postbaseline PD parameter recorded.|||nmol 4-MU/hr/mg protein|||Number
2829727|NCT00304512|Secondary|PK: Area Under The Concentration Versus Time Curve (AUC) After Administration Of Migalastat|The AUC to the last measurable concentration (AUC0-t) was evaluated in plasma following a single oral dose of migalastat on Day 1 and following multiple oral doses on Day 14 (2 weeks) and Day 84 (12 weeks). All samples were collected on each dosing day.|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, and 10 hours (postdose)|PK Population: all participants who received study drug and had at least 1 postbaseline PK parameter recorded.|||nanograms*hours/milliliters (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2829746|NCT00304083|Primary|Number of Participants With Response Rate (Complete Response and Partial Response)|WHO criteria was used to determine responses due to the nonspherical shape of most MPNST. Complete Response (CR), Disappearance of all target lesions; Partial response (PR), >=50% decrease of target lesions.|After 4 Cycles (1 cycle=21 days)|37/48 patients total were evaluable for response.|||Participants|||Count of Participants
2829728|NCT00304512|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Week 48|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2829729|NCT00304356|Primary|Nitazoxanide|stopping of diarrhea|30 days||||participants|||Number
2829730|NCT00304278|Secondary|Survival Post Treatment|Overall Survival with a minimum follow up of 1year. Relapse/Persistent Disease Rates|22 months||||participants|||Number
2829731|NCT00304278|Primary|Number of Participants With Complete and Partial Response Using RECIST Criteria|Complete and Partial Response as defined by RECIST 1.0. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD|17 weeks||||Participants|||Count of Participants
2829732|NCT00304265|Primary|Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.~Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia."|Days 0 to 14 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
2829733|NCT00304187|Primary|Percent of Meal Remaining/Minute|percent of meal remaining/minute|Measured at Week 7||||percent of meal remaining/minute||Standard Error|Mean
2829734|NCT00304187|Primary|Binge Frequency|Binge frequency was assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.|Measured at Week 7|Participants for analysis included 13 patients in the erythromycin and 13 patients in the placebo group who completed at least 5 weeks of drug treatment.|||Binge Episodes/Week||Standard Deviation|Mean
2829735|NCT00304161|Secondary|Clinical Global Impression-Improvement Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale."|Week 8||||percentage of responders|||Number
2829736|NCT00304161|Primary|Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale|The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline.|Week 8||||percentage of improved participants|||Number
2829737|NCT00304096|Secondary|The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization||Days 1-78||||participants|||Number
2829738|NCT00304096|Primary|The Number of Participants Who Experienced Dose-limiting Adverse Events|Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity|30 days post administration of last vaccine||||participants|||Number
2829739|NCT00304083|Secondary|Provide Epidemiology and Clinical Presentation of the Number of Participants With NF1-associated MPNSTs.|Increase the knowledge of the epidemiology and clinical presentation of NF1-associated MPNSTs.|After 4 cycles|Clinical evaluation of patients with NF1 was performed at trial enrollment.|||Participants|||Count of Participants
2829740|NCT00304083|Secondary|Identify the Number of Participants With a Serum Biomarker to Predict the Presence of MPNST Versus Benign Plexiform Neurofibroma|Assess if a serum biomarker can be identified that predicts for the presence of a MPNST versus benign plexiform neurofibroma.|After 4 cycles|Data looked at response evaluable patients with MPNST and focused on the TOPO2A gene being amplified.|||Participants|||Count of Participants
2829741|NCT00304083|Secondary|Construct Tissue Microarray to Identify Novel Targets for Treatment for the Number of Participants With Available Tissue|Construct a tissue microarray from submitted tumor samples that will be used in the future to identify novel targets for treatment of MPNSTs. The tissue microarray looked at various gene deletions and amplifications.|After 4 cycles|The number of participants vary in the rows from overall number analyzed, due to the tissue that was available for testing.|||participants|||Number
2829742|NCT00304083|Secondary|Perform Pathologic Analysis of Tumor Samples to Analyze the Number of Participants With Markers as Predictors of Response|Evaluate the molecular biology of sporadic and NF1-associated MPNSTs by performing a detailed pathologic analysis of tumor samples with the goal to analyze if markers can be identified that predict for response to chemotherapy or outcome.|After 4 cycles|The rows are among three different categories: Histologic Variant, Cellularity and Necrosis.|||Participants|||Count of Participants
2829743|NCT00304083|Secondary|Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens|Correlate response evaluation using WHO, RECIST, 18 FDG-PET and volumetric MRI with percent necrosis in tumor specimens from patients who undergo surgery for local control after chemotherapy.|After 4 cycles|33 patients were evaluable for response after cycle 4, response evaluation using WHO and RECIST was performed. Response evaluation was not assessed with 18 FDG-PET and volumetric MRI.|||Participants|||Count of Participants
2829744|NCT00304083|Secondary|Utility of Fludeoxyglucose F18 Positron Emission Tomography (18FDG-PET) and Automated MRI Volumetric Tumor Analysis to Assess Response to Treatment|Evaluate the utility of fludeoxyglucose F18 positron emission tomography (18FDG-PET) and automated MRI volumetric tumor analysis as tools to assess response to treatment.|After 4 cycles|This assessment involved 18FDG-PET and MRI imaging of the MPNST and plexiform neurofibroma component. Due to technical issues with MRI imaging, data was not reliably collected from any study participant to allow for meaningful analysis.||||||
2829748|NCT00304070|Secondary|Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.|The number of eligible patients who have A43 del33bp mutation of (beta)-catenin.|Patients who had surgery at time of enrollment.|Fifty-eight eligible patients had material examined for the presence of (beta)-catenin mutations.|||Participants|||Count of Participants
2829749|NCT00304070|Secondary|Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.|The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group.|At study enrollment|The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group (Number of patients from Brazil: 23. Number of patients not from Brazil: 31)|||participants|||Number
2829750|NCT00304070|Secondary|Frequency of Lymph Node Involvement by Imaging.|The number eligible patients who have lymph node involvement by imaging at study enrollment.|At study enrollment|Seventy-five eligible patients had tumor imaging done at the time of study enrollment and evaluated for the presence of lymph node involvement|||Participants|||Count of Participants
2829751|NCT00304070|Secondary|Complications Associated With Radical Adrenalectomy and RLND|Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication.|Up to 1 month after surgery|Sixty-nine eligible patients received surgery of the primary tumor site or RPLND. Complication rates were considered over the entire population regardless of Arm/Group assignment. One patient had grade 3 abdominal pain attributed to surgery.|||participants|||Number
2829752|NCT00304070|Secondary|Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy|Up to 182 Days After Enrollment||||participants|||Number
2829753|NCT00304070|Primary|Five Year Event-free Survival (EFS)|The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure.|Up to five years after enrollment||||Estimated probability five year EFS||95% Confidence Interval|Number
2829754|NCT00304031|Secondary|Correlation of PFS With OS at 6 Months||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
2829755|NCT00304031|Secondary|Toxicity||From start of treatment to end of follow-up|||||||
2829756|NCT00304031|Secondary|Correlation of Tumor MGMT Gene Methylation Status With Treatment Response||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
2829757|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Methylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
2829758|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Unmethylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
2829759|NCT00304031|Secondary|Progression-free Survival (PFS)||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.|||||||
2829760|NCT00304031|Primary|Overall Survival (OS)||From randomization to date of death or last follow-up. Analysis occurs after 647 deaths have been reported.|Eligible patients who were randomized to an adjuvant temozolomide arm and contributed follow-up data.|||months||95% Confidence Interval|Median
2829761|NCT00303979|Secondary|Observe the Relative Change Between Baseline of Cohort A and 18 Months of Cohort C in Performance Measures and Composite Score for the Aggregate Practices.|The relative changes between baseline of cohort A and 18 months of cohort C in performance measures and composite score for the aggregate practices were calculated using mean, standard deviation and 95% CI.|baseline and 18 Months||||percentage of participants|Sites|Standard Deviation|Mean
2829762|NCT00303979|Secondary|Observe the Relative Change Between Baseline of Cohort A and 6 Months of Cohort B in Performance Measures and Composite Score for the Aggregate Practices.|The relative changes between baseline of cohort A and 6 months of cohort B in performance measures and composite score for the aggregate practices were calculated using mean, standard deviation and 95% CI.|Baseline and 6 Months||||percentage of participants|Sites|Standard Deviation|Mean
2829763|NCT00303979|Secondary|Observe the Change From Baseline to 24 Months in Each Performance Measure and Composite Score for the Aggregate Practices.|"performance measure improvement for each performance measure was analyzed at a practice level from baseline to 24 months. Performance measure adherence was calculated at the individual practice level and then combined and summarized. Mean, standard deviation, and 95% confidence intervals for performance measure adherence, composite score and relative change (24 months compared with baseline) are reported.~The Composite Score is based on the ratio of the sum of the numerators of all individual performance measures to the sum of the denominators of all individual performances measures. The numerator of a performance measure is the number of patients treated with that measure. The denomiator of a performance measure is the number of patients eligible for being treated with that measure."|24 months||||percentage|Sites|Standard Deviation|Mean
2829764|NCT00303979|Secondary|Observe the Number of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline in Cohort A.|The number of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline of cohort A is presented.|24 months||||Sites|Sites||Number
2829783|NCT00303862|Primary|Objective Response|Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)|Up to 6 weeks||||percentage of participants||95% Confidence Interval|Number
2829765|NCT00303979|Primary|To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change.|"7 performance measures: angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEI/ARB), beta-blokers, aldosterone receptor antagonists, anticoagulation for atrial fibrillation (AF), cardiac resynchronization therapy (CRT-P/CRT-D), cardioverter-defibrillator (ICD/CRT-D), heart failure (HF) education.~We first calcuated % of patients who were eligible for a performance measure that were treated by it at baseline and 24 months. We then calculated the relative change as (% treated at 24 months - % treated at baseline)/% treated at baseline. The 95% confidence interval (CI) was calculated and the relative change of each performance measure was evaluated using a z-test for one-sample proportion.~The number of performance measures with >= 20% relative improvement was determined. The intervention was considered successful if a relative 20% or greater improvement in at least 2 of the 7 performance measures at 24 months compared with baseline was achieved."|24 Month|167 practices contributed data to the baseline chart review. Twelve of the practices withdrew from the study prior to the next chart review milestone. 155 of those practices’ data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop.|||percentage of participants in aggregate||95% Confidence Interval|Number
2829766|NCT00303966|Secondary|Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25|The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early and enrolled only 5 patients. Data wasn't collected for this outcome.||||||
2829767|NCT00303966|Secondary|Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25|Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early after enrolling only 5 patients. Data wasn't collected for this outcome.||||||
2829768|NCT00303966|Secondary|Changes in Mean Microvessel Density From Baseline to Week 25|Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.|Baseline and week 25|Study terminated early with only 5 patients. Data wasn't collected for this outcome.||||||
2829769|NCT00303966|Primary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.|||months||Standard Error|Median
2829770|NCT00303966|Primary|Time to Disease Progression|Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.|||months||Standard Error|Median
2829771|NCT00303966|Primary|Objective Response Rate|Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with >50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).|Up to week 25||||percentage of participants||95% Confidence Interval|Number
2829772|NCT00303953|Secondary|Progression-free Survival|Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|assessed at week 8, then every 3 months for 3 years|Only eligible patients were included in the analyses.|||years||95% Confidence Interval|Median
2829773|NCT00303953|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|assessed every 3 months for 3 years|Only eligible patients were included in the analyses.|||years||95% Confidence Interval|Median
2829774|NCT00303953|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|assessed at week 8, and every 3 months for 3 years|All eligible patients who started treatment were included in assessing response estimates.|||participants|||Number
2829775|NCT00303901|Primary|Distant Failure Rate||at 3, 6, and 12 months||||% of participants with distant failure||95% Confidence Interval|Number
2829776|NCT00303901|Secondary|Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures||12 months after the last patient was enrolled|||||||
2829777|NCT00303901|Secondary|Correlate Procedural Parameters and Follow-up Imaging Parameters||at 3, 6, and 12 months|||||||
2829778|NCT00303901|Secondary|Rate of Complications and Adverse Reactions by Occurrences of Toxicities||at 3, 6, and 12 months|||||||
2829779|NCT00303901|Primary|Local Failure Rates by CT Scan||at 3, 6, and 12 months||||% of participants with local recurrence||95% Confidence Interval|Number
2829780|NCT00303862|Secondary|eNOS|Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.|Baseline (prior to therapy)|Because trial was closed due to poor accrual, assays were not performed.||||||
2829781|NCT00303862|Secondary|KDR|Kinase insert domain-containing vascular endothelial growth factor receptor|Day 28 after initiation of therapy|Because trial was closed due to poor accrual, assays were not performed.||||||
2829782|NCT00303862|Secondary|Performance of DCE_MRI|Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.|One month after initiating therapy|Because trial was closed due to poor accrual, MRI data were not collected.||||||
2829788|NCT00303667|Secondary|Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)|Post-transplant lymphoproliferative disorder (PTLD) is a virally-driven cancer of the lymphoid cells caused by immunosuppressive drugs taken after allogeneic stem cell transplantation to prevent or control graft versus host disease.|1 Year||||participants|||Number
2829789|NCT00303667|Primary|Disease-free Survival at 1 Year|Number of patients alive without evidence of disease at 1 year after transplant|1 Year||||participants|||Number
2829790|NCT00303667|Secondary|Number of Patients With Disease Relapse|Disease relapse is the recurrence of leukemia in patients who had cleared their leukemia after treatment. Patients with persistent leukemia are not evaluable for relapse.|1 Year|On the extended schema, 16/39 patients either did not clear their leukemia or died before relapse would have been detected (day 28), and thus were not evaluable for relapse.|||participants|||Number
2829791|NCT00303667|Secondary|Incidence of Chronic Graft Versus Host Disease|Chronic graft versus host disease is a severe long term complication created by infusion of donor cells into a foreign host|1 Year||||participants|||Number
2829792|NCT00303667|Secondary|Number of Patients With Treatment-Related Mortality|Death within the first 100 days related to treatment in patients without relapse or persistent disease.|Day 100||||participants|||Number
2829793|NCT00303667|Secondary|Incidence of Grade III-IV Acute Graft Versus Host Disease|Grade III-IV acute graft versus host disease is a severe short term complication created by infusion of donor cells into a foreign host|Month 6||||participants|||Number
2829794|NCT00303667|Secondary|Number of Patients With Graft Failure|Number of patients with graft failure defined as <500 donor neutrophils count by day 28 in the absence of residual or relapsed leukemia|Day 28|On the short schema, 1 of the 8 patients, and on the extended schema, 6 of the 39 patients, died prior to Day 28, the day on which engraftment was assessed. Thus, only 7 and 33 patients respectively were evaluable for that endpoint.|||participants|||Number
2829795|NCT00303667|Secondary|In Vivo Expansion of a Donor NK Cells NK Cell Product|Number of patients with in vivo expansion of donor NK cells. In vivo expansion of NK cell is defined as detection of >100 donor-derived NK cells per microliter of blood.|12 - 14 days after NK cell infusion|The protocol was amended to add this endpoint after the 8 subjects were enrolled on the short schema. Thus the relevant samples to determine NK expansion were not collected. On the extended schema, 3 of 39 patients died prior to the day on which in vivo donor NK cell expansion was assessed. Thus only 36 patients were evaluable for that endpoint.|||participants|||Number
2829796|NCT00303667|Primary|Disease-free Survival at 6 Months|Number of patients alive without evidence of disease at 6 months after transplant|Month 6||||participants|||Number
2829797|NCT00303628|Other Pre-specified|Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months|Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their oxaliplatin-related neurotoxicity measured using FACT/GOG Ntx subscale at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.|||scores on a scale||Standard Deviation|Mean
2829798|NCT00303628|Other Pre-specified|Change in Rectal Function Between Baseline and 12 Months|Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their rectal function measured using the Bowel Function Questionnaire at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.|||scores on a scale||Standard Deviation|Mean
2829799|NCT00303628|Secondary|Proportion of Patients Who Completed 12 Cycles of Treatment|In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy.|assessed at the end of treatment|Patients who received at least one cycle of protocol treatment|||proportion of participants|||Number
2829800|NCT00303628|Secondary|Patterns of Failure|Failure included recurrence, second primary cancer and death without recurrence.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|all randomized patients|||participants|||Number
2829801|NCT00303628|Secondary|5-year Disease-free Survival Rate|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)|||proportion of participants||95% Confidence Interval|Number
2829802|NCT00303628|Primary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)|||proportion of participants||95% Confidence Interval|Number
2829803|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale|Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
2829804|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale|Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
2829805|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
2829806|NCT00303602|Secondary|Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint|Patient meets definition of metabolic syndrome if they have >=3 risk factors: Waist circumference (men>102cm, women>88cm); triglycerides >=1.7mmol/L; HDL cholesterol (men<1.04mmol/L, women<1.30mmol/L); blood pressure >135/>=85 mmHg; Fasting glucose >=6.1mmol/L|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||participants|||Number
2829807|NCT00303602|Secondary|Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)|HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward.|||percent sensitivity||Standard Deviation|Mean
2829808|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin||Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||percent||Standard Deviation|Mean
2829809|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin|Patients should be fasting a minimum of eight hours prior to serum insulin measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||microIU/milliliter||Standard Deviation|Mean
2829810|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose|Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||millimole/Liter||Standard Deviation|Mean
2829811|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)|Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||millimole/Liter||Standard Deviation|Mean
2829812|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Blood Pressure|Sitting blood pressure, taken from the same arm.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward|||mm Hg||Standard Deviation|Mean
2829813|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale|Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat|||units on a scale||Standard Error|Least Squares Mean
2829814|NCT00303602|Secondary|Number of Participants Discontinuing the Trial by Visit (Week)|The number of participants who discontinued by visit (non-cumulative).|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat|||participants|||Number
2829815|NCT00303602|Secondary|Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period|Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat|||participants|||Number
2829816|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Waist Circumference|Waist circumference is measured on a bare abodomen just above the hip bone.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward|||centimeters||Standard Deviation|Mean
2829817|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Weight|Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Intention to treat|||kilograms||Standard Error|Least Squares Mean
2829818|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Per protocol|||kilograms/square meters||Standard Deviation|Mean
2829819|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward|||kilograms/square meters||Standard Deviation|Mean
2829820|NCT00303602|Primary|Time Course of Change From Baseline in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.|Visit 2 (Baseline) to Visit 7 (16 Weeks)|Intention to treat|||kilograms/square meters||Standard Error|Least Squares Mean
2829821|NCT00303511|Primary|Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead|The ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure|30 days||||percentage of particiapants|||Number
2829822|NCT00303485|Secondary|Number of Participants With Any Adverse Event or Serious Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 7 months|The Safety Analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment.|||Participants|||Number
2829823|NCT00303485|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 - 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 - 110 U/L), creatinine (0 - 154 µmol/L), chloride (95 - 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula.|Up to 7 months|The Safety analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment. ‘n’ denotes the number of participants who received the indicated study drug for each arm.|||Participants|||Number
2829824|NCT00303485|Secondary|Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations|Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.|Day (D)7, D14, D21 and D28 of Month 6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.|||Percent change||Full Range|Median
2829825|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.|Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percentage of participants|||Number
2829826|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percentage of participants|||Number
2829827|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent|The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percentage of participants|||Number
2829828|NCT00303485|Secondary|Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments|Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7|Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.|||Percent change||95% Confidence Interval|Median
2829829|NCT00303485|Secondary|Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time|BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.|||Percent change||95% Confidence Interval|Median
2829869|NCT00303446|Secondary|Timed 2-minute Walk, Change From Baseline|The subjects did the 2-minute walk in a 50-foot (15.2-meter) corridor three times, and the average distance was calculated. The subjects were allowed to use an assistive device and rest between the trials.|0, 12, and 24 months||||meters||Standard Deviation|Mean
2829830|NCT00303485|Secondary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time|sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. “n” denotes number of participants who received the indicated study drug for each arm.|||Percent change||95% Confidence Interval|Median
2829831|NCT00303485|Primary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day 3|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.|||Percent change||95% Confidence Interval|Median
2829832|NCT00303472|Primary|Part B: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.|Treatment period (8 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication|||Participants|||Number
2829833|NCT00303472|Primary|Part A: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.|Treatment period (4 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication|||Participants|||Number
2829834|NCT00303472|Secondary|Part B: Week 7 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 7|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||Hours||Full Range|Median
2829835|NCT00303472|Secondary|Part B: Week 1 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||Hours||Full Range|Median
2829836|NCT00303472|Secondary|Part B: Week 7 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||hr*pg/mL||Standard Deviation|Mean
2829837|NCT00303472|Secondary|Part B: Week 7 Ctrough|Measured romiplostim concentration at the end of the Week 7 dosing interval (Ctrough)|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
2829838|NCT00303472|Secondary|Part B: Week 7 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
2829839|NCT00303472|Secondary|Part B: Week 1 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||hr*pg/mL||Standard Deviation|Mean
2829840|NCT00303472|Secondary|Part B: Week 1 Ctrough|Measured romiplostim concentration at the end of the week 1 dosing interval (Ctrough)|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
2829841|NCT00303472|Secondary|Part B: Week 1 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||pg/mL||Standard Deviation|Mean
2829842|NCT00303472|Secondary|Part B: Duration of Platelet Response|Duration of platelet response per IWG criteria (absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks).|Treatment Period (8 weeks) and extension period (52 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who had a platelet response|||Weeks||Inter-Quartile Range|Median
2829843|NCT00303472|Secondary|Part B: Time to First Platelet Response|Participants achieving first platelet response according to IWG criteria, by study week. Platelet response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks. Platelet counts obtained within 72 hours of platelet transfusion were not evaluable for platelet response.|Treatment Period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase|||Participants|||Number
2829844|NCT00303472|Secondary|Part B: Peak Platelet Count|Peak platelet count (10^9/L) during the treatment period.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.|||10^9/L||Inter-Quartile Range|Median
2829870|NCT00303446|Secondary|Adult Myopathy Assessment Tool, Change From Baseline|The Adult Myopathy Assessment Tool rates physical function and muscle endurance, with higher scores indicating better performance; it includes 7 timed functional tasks and 6 endurance tasks (0=worst, 45=best).|0, 12, and 24 months||||units on a scale||Standard Deviation|Mean
2829845|NCT00303472|Secondary|Part B: Number of Participants With a Platelet Response Per IWG|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase|||Participants|||Number
2829846|NCT00303472|Secondary|Part A: Number of Participants With a Platelet Response Per IWG Criteria|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (4 weeks) and extension period (52 weeks).|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who entered the treatment extension.|||Participants|||Number
2829847|NCT00303472|Secondary|Part B: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.|||Participants|||Number
2829848|NCT00303472|Secondary|Part A: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (4 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.|||Participants|||Number
2829849|NCT00303459|Secondary|Patient Global Self Assessment (PGSA) Status at Week 16|"The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question How do you feel about your PAH today compared with your last visit? asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse."|Week 16|All randomized set, patients who completed the assessment|||participants|||Number
2829850|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0.|Baseline to Week 16|All randomized set|||units on a scale||Standard Deviation|Mean
2829851|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome).|From baseline to Week 16|All randomized set|||units on a scale||Standard Deviation|Mean
2829852|NCT00303459|Secondary|Change From Baseline to Week 16 in Borg Dyspnea Index|The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal').|Baseline to Week 16|All randomized set|||units on a scale||Standard Deviation|Mean
2829853|NCT00303459|Secondary|Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)|Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory.|Baseline to Month 20|All randomized patients with a baseline and at least one post-baseline value. Assessments considered are those where at least 60% of the patients have a post-baseline value|||Adjusted percentage ratio from baseline||95% Confidence Interval|Geometric Mean
2829854|NCT00303459|Secondary|Time to Death of All Causes From Baseline to End of Study|Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause.|Baseline to End of Study, approximately 86 months|All randomized set|||percentage of participants-Kaplan Meier|||Number
2829871|NCT00303446|Secondary|Manual Muscle Testing, Change From Baseline.|Manual muscle testing was performed using a modified Medical Research Council (MRC) scale (0=worst, 5=best); the average muscle score was based on 22 muscle groups.|0, 12, and 24 months||||MRC units on a scale||Standard Deviation|Mean
2829872|NCT00303446|Secondary|Creatine Kinase, Change From Baseline|Serum creatine kinase was determined in venous blood samples analyzed at the Department of Laboratory Medicine of the NIH Clinical Center.|0, 12, and 24 months||||Units/liter||Standard Deviation|Mean
2829855|NCT00303459|Secondary|Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16|Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.|From baseline to Week 16|All randomized set|||participants|||Number
2829856|NCT00303459|Secondary|Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)|The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period.|From baseline to week 16|All randomized set|||m||Standard Deviation|Mean
2829857|NCT00303459|Secondary|Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation|Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee.|Baseline to end of study, approximately 86 months|All randomized set|||percentage of participants-Kaplan Meier|||Number
2829858|NCT00303459|Primary|Time to First Confirmed Morbidity/Mortality Event up to the End of Study|"Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as moderately or markedly worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied no change or mildly worse on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event."|From baseline to end of study, approximately 86 months|All randomized set|||percentage of participants-Kaplan Meier|||Number
2829859|NCT00303446|Secondary|International Index for Erectile Function (IIEF), Change From Baseline|Sexual function was rated using the International Index of Erectile Function (IIEF). The total IIEF score (5-75, worst-best) was reported as the percent maximum (0-100%).|0, 12, and 24 months||||percent of maximum score||Standard Deviation|Mean
2829860|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Mental Component Summary, Percent Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their mental quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10), and percent change in the norm-based scale was calculated.|0, 12, and 24 months||||percent change||Standard Deviation|Mean
2829861|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Physical Component Summary, Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their physical quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10).|0, 12, and 24 months||||percent change||Standard Deviation|Mean
2829862|NCT00303446|Secondary|Activities of Daily Living, Change From Baseline|Subjects rated their daily activity with a modified 9-question Activities of Daily Living (ADL) questionnaire (0-4, fully impaired to normal).|0, 12, and 24 months||||units on a scale||Standard Deviation|Mean
2829863|NCT00303446|Secondary|Motor Unit Nerve Estimation, Change From Baseline|Motor unit number estimation (MUNE) was done with a statistical MUNE program, on the abductor pollicis brevis. All subjects were evaluated on the right side unless severe atrophy produced very low compound muscle action potentials; in this case, the left side was investigated or the abductor digiti minimi was substituted. A decrease in MUNE indicates a loss of motor units.|0, 12, and 24 months||||motor unit number||Standard Deviation|Mean
2829864|NCT00303446|Secondary|Peroneal Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the peroneal nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months||||mVolts||Standard Deviation|Mean
2829865|NCT00303446|Secondary|Median Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the median motor nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months||||mVolts||Standard Deviation|Mean
2829866|NCT00303446|Secondary|Sensory Nerve Action Potential Average, Change From Baseline|Nerve conduction studies were done on four sensory nerves (median, ulnar, radial, sural), and the amplitudes of the evoked responses were averaged. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months||||microVolts||Standard Deviation|Mean
2829867|NCT00303446|Secondary|Bulbar Rating Scale, Change From Baseline|The Bulbar Rating Scale includes eight domains each rated on a 1-4 scale, abnormal to normal. The original 8-32 point scale was transformed to a 0-100% scale to represent the responses as percentages.|0, 12, and 24 months||||percentage of maximum score||Standard Deviation|Mean
2829868|NCT00303446|Secondary|Swallow Score Average, Change From Baseline|Modified barium swallow studies were done at 0, 12, and 24 months. Twenty-five domains were assessed, and six were chosen for final analysis based on the abnormal findings in subjects evaluated at baseline: vallecular pooling and repeated-swallow, each assessed with thin liquids, purees, and solids (rated 1-4, abnormal to normal).|0, 12, and 24 months||||units on a scale||Standard Deviation|Mean
2829873|NCT00303446|Primary|Muscle Strength Change From Baseline|Quantitative muscle assessment (QMA) was done with a fixed frame dynamometer, a strain gauge tensiometer, and a computer-aided acquisition system. Maximal voluntary isometric muscle contractions were measured twice, the average was calculated, and the results were summed over 22 muscle groups (11 on each side). The total force was scaled for body weight and expressed as percent change from baseline. Measurements were performed at 0, 12, and 24 months. The calculated percent changes at 12 and 24 months are shown.|0, 12, and 24 months|The participants analyzed were those who were available for analysis at 12 and 24 months.|||percent change||Standard Deviation|Mean
2829874|NCT00303329|Secondary|The Absolute Change in Serum Ferritin (μg/L) Levels From Baseline to the End of the Study|Serum ferritin was monitored monthly and the dose of deferasirox was increased or decreased in steps of 5 to 10 mg/kg/day up to a maximum of 40 mg/kg/day if appropriate, every 3 months. If serum ferritin fell to 500 ng/mL or lower on two consecutive study visits, an interruption of treatment until serum ferritin was more than 500 ng/mL was considered.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||μg/L||Standard Deviation|Mean
2829875|NCT00303329|Secondary|The Absolute Change in Liver Iron Content (LIC) as Assessed by Superconducting Quantum Interference Device (SQUID) From Baseline to End of Study|Liver iron concentration was monitored at the end of the core study and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant. Pediatric participants or participants with a medical contraindication to liver biopsy were allowed the use of SQUID in the extension study.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||mg Fe/g dw||Standard Deviation|Mean
2829876|NCT00303329|Secondary|The Change in Liver Iron Content (LIC) as Assessed by Liver Biopsy at Baseline to the End of the Study|Liver iron concentration was monitored at the start of the core study, the end of the core study, and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant.|Core study Baseline to end of extension study (up to 60 months)|The full analysis Set (FAS) comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||mg Fe/g dw||Standard Deviation|Mean
2829877|NCT00303329|Primary|The Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Core study Baseline to the end of the study (up to 60 months)|The safety analysis set comprised all participants who received at least one dose of deferasirox during either the core or extension studies.|||Participants|||Number
2829878|NCT00303316|Primary|Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|"Antibody titers determination:~Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay."|Day 0 (pre-booster) and Day 30 post-booster|Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
2829879|NCT00303316|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable."|Day 0 up to Day 30 post-booster vaccination|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.|||Participants|||Number
2829880|NCT00303316|Primary|Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.|Day 30 Post-booster Vaccination|Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).|||Participants|||Number
2829881|NCT00303316|Primary|Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).|Day 0 (Before booster vaccination)|Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).|||Participants|||Number
2829913|NCT00303108|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Evaluable population|||percentage of participants||95% Confidence Interval|Number
2829882|NCT00303186|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829883|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
2829884|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829885|NCT00303186|Secondary|Health Assessment Questionnaire (HAQ)|HAQ: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829886|NCT00303186|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.|||minutes||Standard Deviation|Mean
2829887|NCT00303186|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2829888|NCT00303186|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm/hr||Standard Deviation|Mean
2829889|NCT00303186|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
2829890|NCT00303186|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
2829891|NCT00303186|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Measured using a 100 millimeter (mm) VAS ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||mm||Standard Deviation|Mean
2829892|NCT00303186|Secondary|Radiographic Score Based on Wassenberg|Radiographic score based on wassenberg consisted of 2 sub-scores, proliferation score (PS) assessing bone proliferation and destruction score (DS) assessing joint surface destruction. Score range for PS and DS was 0 to 160 (where higher score represented higher bone proliferation) and 0 to 200 (where higher score represented higher destruction), respectively. Total score = sum of PS and DS (range 0 to 360); higher score represented worse state.|Baseline, Month 12, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829893|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||percentage of participants|||Number
2829894|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||percentage of participants|||Number
2829895|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||percentage of participants|||Number
2829896|NCT00303186|Secondary|Number of Swollen and Tender Joints|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||joints||Standard Deviation|Mean
2829897|NCT00303186|Secondary|Maastricht Ankylosing Spondylitis Enthesis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829898|NCT00303186|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||cm||Standard Deviation|Mean
2829899|NCT00303186|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||cm||Standard Deviation|Mean
2829900|NCT00303186|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bend forward, knees fully extended, with spine in full flexion.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||cm||Standard Deviation|Mean
2829901|NCT00303186|Secondary|Bath Ankylosing Spondylitis Radiology Index (BASRI)|BASRI- Radiographs of participants with AS were scored using the New York criteria for the sacroiliac joints on a scale of 2 to 4, the lumbar and cervical spine on a scale of 0 to 4 (0 = normal, 1 = suspicious, 2 = mild, 3 = moderate, 4 = severe). These 3 scores were added together to produce the BASRI-spine (BASRI-s) score (range 2 to 12). Similarly, hip joints were scored on a scale of 0 to 4 to give BASRI-hip (BASRI-h). Sum of BASRI-s and BASRI-h produced BASRI-total (BASRI-t) score; total range 2 to 16, higher score represented worse health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.|||units on a scale||Standard Deviation|Mean
2829902|NCT00303186|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829903|NCT00303186|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a Visual Analog Scale (VAS) of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions. Total possible score range: 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829904|NCT00303186|Secondary|Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||units on a scale||Standard Deviation|Mean
2829905|NCT00303186|Secondary|Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)|PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||participants|||Number
2829906|NCT00303186|Secondary|Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change >= 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.|||participants|||Number
2829907|NCT00303186|Primary|Incremental Cost-effectiveness Ratio (ICER)|ICER: ratio of the incremental cost of treatment over the incremental effectiveness. Incremental cost = difference in cost between baseline and month 60. Effectiveness was defined as quality adjusted life year (QALY) gained, i.e. difference in Euro Quality of Life 5 Dimension (EQ-5D)- health state profile utility score between baseline and month 60. (EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Total score range -0.594 to 1.000; higher score indicates a better health state.)|Baseline up to Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||ratio||95% Confidence Interval|Number
2829908|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 60|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Euro/participant-month||Standard Deviation|Mean
2829909|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 12|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 12|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.|||Euro/participant-month||Standard Deviation|Mean
2829910|NCT00303108|Secondary|1-year Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year|ITT population|||probability of overall survival||95% Confidence Interval|Number
2829911|NCT00303108|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel."|30 months|ITT population|||months||Full Range|Median
2829912|NCT00303108|Secondary|Duration of Response|Duration from date of stating treatment to the date of first CR or PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Patients who achieved CR or PR.|||months||Full Range|Median
2829962|NCT00302159|Primary|Median Overall Survival|Survival is the interval from the initiation of treatment on protocol to date of death.|up to 63.8 months||||months||95% Confidence Interval|Median
2829914|NCT00303069|Secondary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination||Baseline and Day 7 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.|||Participants|||Number
2829915|NCT00303069|Primary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination||Baseline and Day 14 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.|||Participants|||Number
2829916|NCT00303069|Primary|Number of Vaccine-related Serious Adverse Experiences Following Vaccination|Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|Through Day 84 postvaccination|The population analyzed included all subjects who were randomized, vaccinated, and had safety follow-up.|||Participants|||Number
2829917|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||fL||Standard Deviation|Mean
2829918|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||pg||Standard Deviation|Mean
2829919|NCT00302952|Primary|Change From Baseline in Red Cell Distribution Width (RDW) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||% of mean corpuscle volume||Standard Deviation|Mean
2829920|NCT00302952|Primary|Change From Baseline in Hematocrit (Hct) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||% of packed red blood cells by volume||Standard Deviation|Mean
2829921|NCT00302952|Primary|Change From Baseline in Counts: White Blood Cells (WBC), Neutrophils, Bands, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, and Reticulocytes at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||10^3/uL||Standard Deviation|Mean
2829922|NCT00302952|Primary|Change From Baseline in CPK at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||U/L||Standard Deviation|Mean
2829923|NCT00302952|Primary|Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||mmol/L||Standard Deviation|Mean
2829964|NCT00302159|Primary|Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months|Percentage of participants who were progression free by 6, 12, or 24 months. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|6, 12, and 24 months||||percentage of participants|||Number
2829924|NCT00302952|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||g/dL||Standard Deviation|Mean
2829925|NCT00302952|Primary|Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||mg/dL||Standard Deviation|Mean
2829926|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum Anti-cyclic Citrullinated Peptide (Anti-CCP) by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Anti-CCP antibodies are autoantibodies frequently detected in the serum of individuals with rheumatoid arthritis. In this study, a positive value for anti-CCP was 8 IU/mL or greater; a negative value for anti-CCP was <8 IU/mL. Change= subtraction of Day 0 from Day 84 anti-CCP value. In general, high levels of the antibody indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline ( Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data|||IU/mL||Standard Error|Mean
2829927|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum IgM Rheumatoid Factor by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Rheumatoid factor (RF) is an antibody often present in the blood of a person with rheumatoid arthritis. In this study, a positive value for RF was 0.5 IU/mL or greater; a negative value for RF was <0.5 IU/mL. Change= Day 84 value minus Baseline value. In general, presence of the antibody indicates aggressive rheumatoid arthritis and higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data|||IU/mL||Standard Error|Mean
2829928|NCT00302952|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Day 84 (ACR: American College of Rheumatology)|Patients were ACR20 Responders if they had: at least 20% improvement in both tender joint count (28 examined) and swollen joint count (28 examined), and 20% improvement in at least three of the following 5 remaining ACR core measures: • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) • Patient's global assessment of disease activity (VAS 100 mm) • Physician's global assessment of disease activity (VAS 100 mm) • Patient self-assessed disability (Health Assessment Questionnaire (HAQ)) score • Acute phase reactant C-reactive protein. Participants with measurements for designated time points were included in analysis.|Day 84 (Wk 12)|Intent-to-Treat with Available Data|||Percentage of participants|||Number
2829929|NCT00302952|Secondary|Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84|The DAS28-CRP score is on a scale of 0 to 10 and indicates current activity of rheumatoid arthritis (>5.1=high disease activity; 3.2-<=5.1=moderate disease activity; <=3.2=low disease activity; <2.6=remission). The score uses a combination of four variables: 1) the number of tender joints (of the 28 that are measured); 2) the number of swollen joints (of the 28 that are measured); 3) serum C-reactive protein (CRP) lab value in mg/L , and 4) Patient Global Assessment of Disease Activity. Using a formula, the physician determines the score. Participants with measurements for designated time points included in analysis.|Baseline (Day 0) to Day 84 (Wk 12)|Intent-to-Treat with Available Data|||Scores on a scale||Standard Error|Mean
2829930|NCT00302952|Primary|Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety|||U/L||Standard Deviation|Mean
2829931|NCT00302952|Primary|Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84|Blood draw for CRP, an acute phase reactant used to identify the presence of nonspecific inflammation. Change=Day 84 value minus Baseline value. Normal serum CRP reference range in this study is 0-4 mg/L (log transformed: -4.2 to 1.4). Participants with measurements for designated time points were included in analysis. An increased CRP level indicates the presence of inflammation. Reduced CRP levels could mean a decrease in inflammation.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with available data|||mg/L||Standard Error|Mean
2829932|NCT00302848|Primary|Number of Participants With Venous Thromboembolism (VTE)||1.5 to 5 years|"The primary analysis compares the users of DRSP and LNG. Its results are presented below. The comparison of users of DRSP and OCs containing other progestins was only conducted for exploratory reasons. This secondary analysis showed similar results and is described in more detail in the publication of study results, see citations."|||Participants|||Number
2829933|NCT00302731|Secondary|Number of Participants Without Change in Baseline and Follow up Bone Density|Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below.|baseline and 12 months|Only 7 participants completed both the baseline bone density and 12-month follow up bone density resulting in a discrepancy in evaluable numbers compared to other outcome measures.|||Participants|||Count of Participants
2829934|NCT00302731|Primary|Number of Participants Without Change in Baseline and Follow up Mammograms|Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.|baseline and month 12||||Participants|||Count of Participants
2829935|NCT00302731|Primary|Endometrial Measurement|Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion.|Baseline and month 12||||mm||Standard Deviation|Mean
2829936|NCT00302731|Primary|Change in Total Cholesterol|To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion.|Baseline and month 12||||mg/dL||Standard Deviation|Mean
2829937|NCT00302718|Secondary|Beta Blocker Use|This measure reports the proportion of patients with beta blocker use at the time of the index visit for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant|Final intervention period (April-July 2009)|All patients with at least one of the following: 1) a history of diagnosis of ischemic heart disease (IHD), angioplasty, or CABG; 2) a history of myocardial infarction (MI); 3) patients who have a history of USA. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829938|NCT00302718|Secondary|Beta Blocker Use|This measure reports the proportion of patients with beta blocker use at the time of the index visit for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Baseline period (August - November 2007)|All patients with at least one of the following: 1) a history of diagnosis of ischemic heart disease (IHD), angioplasty, or CABG; 2) a history of myocardial infarction (MI); 3) patients who have a history of USA. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829939|NCT00302718|Secondary|Hemoglobin (Hb) A1c Levels|This measure reports the proportion of patients with (Hb)A1c control ((Hb)A1c ≤ 9%) for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Final intervention period (April-July 2009)|All patients with a compelling indication of diabetes, including a history of diagnosis of diabetes, was taking diabetes medications at index visit, or has a fasting blood sugar level ≥ 126 or random blood sugar ≥ 200. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829940|NCT00302718|Secondary|Hemoglobin (Hb) A1c Levels|This measure reports the proportion of patients with (Hb)A1c control ((Hb)A1c ≤ 9%) for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Baseline period (August-November 2007)|All patients with a compelling indication of diabetes, including a history of diagnosis of diabetes, was taking diabetes medications at index visit, or has a fasting blood sugar level ≥ 126 or random blood sugar ≥ 200. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829941|NCT00302718|Secondary|Low-density Lipoprotein (LDL) Cholesterol Levels|This measure reports the proportion of patients who had LDL control (LDL cholesterol < 100) for the fifth and final intervention performance period. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Final intervention period (April-July 2009)|All patients at high risk for elevated LDL. These patients have any of the following: 1) a history of ischemic heart disease, angioplasty, or coronary artery bypass grafting; 2) a history or diagnosis of peripheral artery disease or aortic aneurism; 3) a compelling indication of diabetes. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829942|NCT00302718|Secondary|Low-density Lipoprotein (LDL) Cholesterol Levels|This measure reports the proportion of patients who had LDL control (LDL cholesterol < 100) for the first performance period (baseline). We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Baseline period (August-November 2007)|All patients at high risk for elevated LDL. These patients have any of the following: 1) a history of ischemic heart disease, angioplasty, or coronary artery bypass grafting; 2) a history or diagnosis of peripheral artery disease or aortic aneurism; 3) a compelling indication of diabetes. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829943|NCT00302718|Secondary|Colorectal Cancer (CRC) Screening|This measure reports the proportion of patients who had at least one of four CRC screens in the appropriate timeframe for the fifth and final intervention performance period. Appropriate CRC screens consisted of at least one of the following: 1) fecal occult blood test every year; 2) barium enema every five years; 3) flexible sigmoidoscopy every five years; 4) colonoscopy every ten years. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Final intervention period (April-July 2009)|All patients aged 51-74 at the time of qualifying visit with no history of CRC. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829944|NCT00302718|Post-Hoc|Incidence of Hypotension Among All Patients With Hypertension|Patients had at least one primary care encounter during the interval assessed. We looked four months from the encounter for evidence of hypotension, either an outpatient systolic blood pressure (BP) < 90 mm Hg, an outpatient diagnosis of hypotension, or both.|Intervention period (February-May 2009)|All patients with hypertension from the physicians' panel who had an outpatient encounter between February and May 2009. We used data from automated processing of structured fields from electronic health records to evaluate this measure.|||percentage of all hypertensive patients|patient records||Number
2829945|NCT00302718|Secondary|Colorectal Cancer (CRC) Screening|This measure reports the proportion of patients who had at least one of four CRC screens in the appropriate timeframe for the first performance period (baseline). Appropriate CRC screens consisted of at least one of the following: 1) fecal occult blood test every year; 2) barium enema every five years; 3) flexible sigmoidoscopy every five years; 4) colonoscopy every ten years. We did not measure the pre-specified post washout period results for this secondary outcome. The pre-specified post washout period results were not to be measured if the final intervention period results were not significant.|Baseline period (August - November 2007)|All patients aged 51-74 at the time of qualifying visit with no history of CRC. We used data from chart reviews to evaluate this measure.|||percentage of physicians' patients|patient records||Number
2829946|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Patient records||Number
2829947|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Patient records||Number
2829948|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Patient records||Number
2829949|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Patient records||Number
2829963|NCT00302159|Primary|Number of Participants With Best Response|Best response recorded from the start of treatment until disease progression/recurrence. Complete response is complete resolution of all contrast enhancing tumor documented at initiation of treatment on protocol, with no appearance of new lesions. Partial response is a >50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Minor response is a >25%, but <50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Stable disease is a change in tumor size less than MR but not demonstrating progressive disease. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol. Not evaluable means the participant cannot be evaluated (e.g., quality of scan).|up to 63.8 months||||participants|||Number
2829950|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Patient records||Number
2829951|NCT00302718|Primary|Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.|||percentage of physicians' patients|Patient records||Number
2829952|NCT00302458|Primary|Peak Plasma Concentration of d-Methylphenidate|Objective measure determined from blood samples, measured 4 hours after the dose|4 hours|All subjects received each combination of medications on a separate day (total= 5 days)|||mg/L||Standard Deviation|Mean
2829953|NCT00302328|Secondary|Visual Field Defects|visual field defects measured on humphrey perimetry|6 months|from predetermined power analysis|||participants|||Number
2829954|NCT00302328|Secondary|Anatomic Success|closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)|macular hole closure at 12 months|from initial power calculation of primary end point|||participants|||Number
2829955|NCT00302328|Primary|Visual Acuity (ETDRS Letters)|Visual acuity measured as the number of ETDRS letters at last follow-up|Visual acuity at 12 months|Decided from initial power calculation|||Visual acuity in letters||Standard Error|Mean
2829956|NCT00302211|Post-Hoc|Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period|The number of participants in the double-blind treatment period who showed improvement or worsening in the 6-MWT - from baseline distance between 100-450 meters - was assessed for each treatment group. The 6-minute walks were measured in meters. Any increase in walk distance at Week 16 was considered improvement from baseline, any decrease was considered as deterioration from baseline.|Week 16|Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had a post-baseline efficacy measure at Week 16.|||Participants|||Count of Participants
2829957|NCT00302211|Other Pre-specified|Number of Participants With Any Adverse Events|This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit.|From Day 1 to Week 16 and Week 48|Safety population: All randomiized subjects who received at least one dose of the study drug|||Participants|||Count of Participants
2829958|NCT00302211|Secondary|Time to Clinical Worsening|Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported.|Week 16 and Week 48|Only participants who received at least one dose of study drug and with available data at Week 16 (for the double-blind period) and at Week 48 (for the open-label period) were included in the analysis|||Participants|||Count of Participants
2829959|NCT00302211|Secondary|Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16|This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.|Day 1 and Week 16|Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed.|||Participants|||Count of Participants
2829960|NCT00302211|Primary|Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period|The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.|Day 1 and Week 16|Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed.|||Meters||Standard Deviation|Mean
2829961|NCT00302159|Primary|Percentage of Participants With Overall Survival at 6, 12, and 24 Months|Percentage of participants who were alive at 6, 12, and 24 months.|6, 12, and 24 months||||percentage of participants|||Number
2829966|NCT00302159|Primary|Median Progression Free Survival.|Progression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|up to 51 months||||months||95% Confidence Interval|Median
2829967|NCT00302133|Secondary|% Subjects Abstinent|Proportion of subjects abstinent during the last 4 weeks of the trial|12 weeks||||percentage of participants|||Number
2829968|NCT00302133|Primary|Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial||12 weeks|One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment.|||standard drinks/drinking day||Standard Deviation|Mean
2829969|NCT00302107|Primary|Structured Interview of Posttraumatic Stress Disorder (SIP)|Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).|Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.|Randomized, took at least one dose of study medication, and returned for at least one visit post-randomization|||units on a scale||Standard Deviation|Mean
2829970|NCT00302081|Secondary|Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up.|"Virologic response is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) in the serum. A blood test is used to measure the level of ALT and AST. ALT response was defined as ALT<40 IU/L (international units per liter).~This was not a prespecified key secondary outcome."|End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.|||||||
2829971|NCT00302081|Primary|The Number of Participants Who Achieve a Sustained Virologic Response (SVR)|A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid [HCV-RNA] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.|24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.|Intent-to-Treat (ITT) population|||participants|||Number
2829972|NCT00302068|Secondary|Interleuken 6 (IL-6)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||pg/ml||Standard Deviation|Mean
2829973|NCT00302068|Secondary|Baroreflex Sensitivity (BRS)||Baseline, 16 weeks|Analysis based on 92 participants with valid baseline measurement.|||msec/mmHg||Standard Deviation|Mean
2829974|NCT00302068|Secondary|Platelet Factor 4||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||IU/ml||Standard Deviation|Mean
2829975|NCT00302068|Secondary|C-reactive Protein (CRP)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||ug/ml||Standard Deviation|Mean
2829976|NCT00302068|Secondary|Percent Change in Flow Mediated Dilation (FMD)|Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.|Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||percentage change|||Number
2829977|NCT00302068|Secondary|Heart Rate Variability (HRV)|HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R—R intervals (SDNN)|Baseline, 16 weeks|Analysis based on 93 participants with valid baseline measurements.|||millisecond||Standard Deviation|Mean
2829978|NCT00302068|Primary|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.|Measured at 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.|||Raw changes in Ham-D scores||95% Confidence Interval|Mean
2829979|NCT00302055|Secondary|Rate of Community Program Participation||6 months|||||||
2829980|NCT00302055|Secondary|Self Report Physical Activity||12 months|||||||
2829981|NCT00302055|Primary|Weight Loss|We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)|12 months||||kilograms||95% Confidence Interval|Mean
2829982|NCT00302042|Secondary|Change in Dietary Composition||Baseline, 6 months|||||||
2829983|NCT00302042|Secondary|Rate of Community Program Participation||Baseline, 6 months|||||||
2829984|NCT00302042|Secondary|Physical Activity Level||Baseline, 6 months|||||||
2829985|NCT00302042|Primary|Change in Weight|6 months minus baseline|Baseline, 6 months||||percentage of change in weight||95% Confidence Interval|Mean
2829986|NCT00302003|Secondary|Overall Survival|Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.|At 60 months|Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).|||Probability of survival||95% Confidence Interval|Number
2829987|NCT00302003|Primary|Event Free Survival (EFS)|Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).|At 60 months|Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).|||Probability of survival||95% Confidence Interval|Number
2829988|NCT00302003|Primary|Intensive Therapy Free Survival (ITFS).|Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).|||Probability of survival||95% Confidence Interval|Number
2829989|NCT00302003|Primary|Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).|Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).|||Probability of survival||95% Confidence Interval|Number
2829990|NCT00301964|Secondary|Histologic Grade|G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2829991|NCT00301964|Secondary|Initial Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2829992|NCT00301964|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients.|||months||Inter-Quartile Range|Median
2829993|NCT00301964|Secondary|Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for the first 6 months; then every 4 cycles until progression or death, up to 5 years.|Eligible and treated patients.|||months||Inter-Quartile Range|Median
2829994|NCT00301964|Primary|Number of Patients With Toxicity of Bevacizumab as Assessed by CTCAE v3.0 in This Cohort of Patients.||Up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
2829995|NCT00301964|Primary|Best Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|study entry through completion|Total number eligible and evaluable participants|||participants|||Number
2829996|NCT00301964|Primary|Progression-free Survival Greater Than 6 Months|Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|6 months|Total number of eligible and evaluable participants|||participants|||Number
2829997|NCT00301873|Secondary|Mean Change in Bone Mass Density (BMD)|Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.|6 & 12 months|59 patients were accrued to the study; however follow-up at 6 months was available from 27 patients and at 12 months data was available from 19 patients.|||T score units||Standard Deviation|Mean
2829999|NCT00301873|Primary|Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.|Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.|6 and 12 months|59 patients were accrued; however only 27 had a follow-up assessment at 6 months and 19 at 12 months.|||percentage of patients|||Number
2830000|NCT00301834|Secondary|Disease-free Survival With Correction of Disease at One Year Post Transplantation|"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation"|1 year post-transplantation||||participants|||Number
2830001|NCT00301834|Secondary|Cytomegalovirus (CMV) Viral Infection and Disease Symptoms|polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months.|Up to one year post-transplant|4 participants were incapable of producing Ab or CMV testing result was indeterminate|||participants|||Number
2830002|NCT00301834|Secondary|Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation||1 year post-transplantation||||participants|||Number
2830003|NCT00301834|Secondary|Treatment-related Mortality at 100 Days and 1 Year Post Transplantation||100 days and 1 year||||participants|||Number
2830004|NCT00301834|Primary|Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation|Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences|6 weeks post-transplant|Participants evaluable for engraftment 6 weeks post-transplant; 1 patient died of transplant-related hemorrhage prior to 6 weeks and was not evaluated for this outcome|||participants|||Number
2830005|NCT00301821|Secondary|Overall Response Rate (ORR)|Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|Baseline to first 6 cycles of treatment|Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.|||percentage of participants|||Number
2830006|NCT00301821|Secondary|Progression-free Survival (PFS)|Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|the time from study entry to 36 months|Intent To Treat (All Patients)|||percentage of participants|||Number
2830007|NCT00301821|Secondary|Overall Survival|Percentage of participants alive at different time points|time from study entry to 36 months|Intent To Treat (All Patients)|||percentage of Participants|||Number
2830008|NCT00301821|Primary|Event-free Survival After 12 Months|The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).|From Baseline to 12 months|First 76 eligible participants were included in this analysis.|||percentage of participants|||Number
2830009|NCT00301808|Secondary|Toxicity|Toxicity: total number of SAEs and other AEs|72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year||||Adverse event|||Number
2830010|NCT00301808|Secondary|Overall Survival|Overall survival using Kaplan-Meier estimates|Date of registration to the date of death||||months||95% Confidence Interval|Median
2830011|NCT00301808|Secondary|Progression-free Survival|Progression-free survival using Kaplan-Meier estimates|Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.||||months||95% Confidence Interval|Median
2830012|NCT00301808|Primary|Probability of Overall Survival at One Year|Overall Survival at one year using Kaplan-Meier product-limit analysis|at 1 year||||probability of overall survival at 1 yr.||95% Confidence Interval|Number
2830013|NCT00301756|Other Pre-specified|Relationship Between Clinical and Pharmacodynamic Effects of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors|Summarized using summary statistics, such as the mean, median, and range. Tested using one-sample t-tests or Wilcoxon rank sum tests. Logistic regression analysis will be used to test significance.|Up to 5 years|||||||
2830014|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|18 patients from Epithelian Ovarian Cancer patients were analyzed|||participants|||Number
2830015|NCT00301756|Secondary|Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years||||months||95% Confidence Interval|Median
2830016|NCT00301756|Secondary|Number of Grade 3 Adverse Events Using the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Events of Thrombosis, Hypersensitivity and ALP will be tabulated.|Up to 5 years|18 patients with Epithelial ovarian cancer (EOC) and 14 patients with Micro-papillary ovarian tumor (LMP)|||events|||Number
2830017|NCT00301756|Secondary|Overall Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years|Data were not collected||||||
2830018|NCT00301756|Secondary|Progression-free Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Duration of time from start of treatment to time of progression, assessed up to 5 years||||months||95% Confidence Interval|Median
2830019|NCT00301756|Secondary|Duration of Response|Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|No participants had an objective response out of the 32 patients analyzed.||||||
2830020|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed|||participants|||Number
2830021|NCT00301756|Secondary|Time to Disease Progression (Epithelial Ovarian Cancer Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years|Eighteen patients with Epethelial Ovarian Cancer were analyzed|||months||95% Confidence Interval|Median
2830022|NCT00301756|Primary|Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD|Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.|Up to 5 years||||participants|||Number
2830023|NCT00301418|Secondary|Overall Survival (OS)||Duration of the trial||||days||95% Confidence Interval|Median
2830024|NCT00301418|Secondary|6-month Progression Free Survival (PFS)||Duration of the trial||||days||95% Confidence Interval|Median
2830025|NCT00301418|Primary|Safety of Twice a Day Oral 150 mg Erlotinib Dosing|Greater than or equal to Grade 2 Adverse Event|duration of the trial||||participants|||Number
2830026|NCT00301366|Primary|Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.|An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.|24 weeks|38 subjects received study medication and one subject discontinued from the study due to an AE. Therefore, 37 subjects completed the study. 18 subjects were naive ((i.e., never having received previous Alpha-1 protease inhibitor augmentation therapy) and 19 subjects were non-naive.|||Participants|||Number
2830027|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections|Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830028|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4|Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830029|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4|Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830030|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3|Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830031|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2|Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830032|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1|Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830033|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0|Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830034|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830035|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4|Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830036|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830037|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2|Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830038|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1|Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <= Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830039|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0|Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830040|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ3|GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.|||subjects|||Number
2830041|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ2|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.|||subjects|||Number
2830042|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.|||subjects|||Number
2830043|NCT00301262|Secondary|Analog Scales- General Sexual Performance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830044|NCT00301262|Secondary|Analog Scales- Reliability|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830045|NCT00301262|Secondary|Analog Scales- Maintenance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830046|NCT00301262|Secondary|Analog Scales- Firmness|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830047|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- General Sexual Performance|mean change - scale of 0 (worst) to 10 (best)|baseline to week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830048|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Reliability|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830049|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Maintenance|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation|||units on a scale||Standard Deviation|Mean
2830051|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm Event Log|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830052|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830053|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation|||Percentage of occasions||Standard Deviation|Mean
2830054|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation|||percentage of occasions||Standard Deviation|Mean
2830055|NCT00301262|Secondary|Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.|Week 8, Week 14|number of subjects in the FAS population with an observation|||percentage of subjects|||Number
2830056|NCT00301262|Secondary|Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|"GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes. % of responders/non-responders was calculated based on subjects who attempted intercourse."|Week 8, Week 14|number of subjects in the FAS population with an observation|||percentage of subjects|||Number
2830057|NCT00301262|Secondary|Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|"GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering Yes. % of responders/non-responders was calculated based on subjects who attempted intercourse."|Week 8, Week 14|number of subjects in the FAS population with an observation|||percentage of subjects|||Number
2830058|NCT00301262|Secondary|Quality of Erection Questionnaire (QEQ) Total Score|QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8, Week 14|Full Analysis Set|||scores on a scale||Standard Deviation|Mean
2830059|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score|adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830060|NCT00301262|Secondary|Erectile Distress Scale (EDS) Total Score|Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830061|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score|adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830062|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830063|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830064|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830065|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830066|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830067|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830068|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830069|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830070|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830071|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830072|NCT00301262|Secondary|Patient Reported Erectile Function Assessment (PREFA) Total Score|PREFA Total Score: 8 = worst, 32 = best.|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830073|NCT00301262|Secondary|Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score|adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.|Week 8|number of subjects in the FAS population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830074|NCT00301262|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index|Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8, Week 14|number of subjects in the FAS population with an observation|||scores on a scale||Standard Deviation|Mean
2830075|NCT00301262|Primary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)|adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8|number of subjects in the Full Analysis Set (FAS) population with an observation|||scores on a scale||Standard Error|Least Squares Mean
2830076|NCT00301080|Secondary|Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment|Record the amount of opioid medication used by patients in each arm before and after the study treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
2830077|NCT00301080|Secondary|Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane|Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
2830078|NCT00301080|Secondary|Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
2830079|NCT00301080|Secondary|Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period|Compare individual patients' self-reported pain relief scores before and after the treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
2830080|NCT00301080|Primary|Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory|Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.||||||
2830081|NCT00301067|Post-Hoc|Overall Survival (OS) Stratified by Vitamin D-Receptor (VDR) Gene Polymorphisms|Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and Overall Survival (OS). VDR gene analysis was completed using PCR-RFLP based assays.|at baseline and until death from any cause up to 6 and half years|Cohort results for this outcome measure are combined as the objective was to determine the relationship between VDR gene polymorphisms and OS for patients with this drug combination (dose was irrelevant)|||Months||Inter-Quartile Range|Median
2830082|NCT00301067|Post-Hoc|Overall Survival|Overall Survival (OS) will be measured from first day of treatment until death of any cause. Patients still alive at the last data cut off point will be censored.|From the first day of treatment until death from any cause, up to a maximum of 6 and half years|Cohort results for this outcome measure are combined as the objective was to determine the OS of patients with this drug combination (dose was irrelevant)|||Months||Inter-Quartile Range|Median
2830083|NCT00301067|Post-Hoc|Time to Progression|Time to progression (TTP) is measured from the start of treatment until the time of first documentation of disease progression.|From the start of treatment, until progressive disease, up to 12 months|Cohort results for this outcome measure are combined as the objective was to determine the TTP for patients with this drug combination (dose was irrelevant)|||Months||Inter-Quartile Range|Median
2830084|NCT00301067|Post-Hoc|Overall Response Rate|"Overall Response Rate (ORR) is defined as percentage of patients who's best response to treatment is complete response plus those with partial response.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|From the start of treatment, every 2 cycles where 1 cycle equals 28 days, for a maximum of 12 cycles|Cohort results for this outcome measure are combined as the objective was to determine the ORR of patients with this drug combination (dose was irrelevant)|||Participants|||Count of Participants
2830085|NCT00301067|Secondary|The Relationship Between Vitamin D-receptor Gene Polymorphisms and Tumor Response|Investigate the relationship between vitamin D-receptor (VDR) gene polymorphisms in Taq1 and Fok1 (analyzed from baseline blood sample) and tumor response. VDR gene analysis was completed using PCR-RFLP based assays.|Baseline and at disease progression or when patient goes off study up to a maximum of 12 months|Cohort results for this outcome measure are combined as the objective was to investigate relationship of VDR gene polymorphisms present and tumor response of patients with this drug combination (dose was irrelevant) Data was not collected or analyzed for this outcome measure.||||||
2830086|NCT00301067|Secondary|Tumor Response|"Determine best tumor response during treatment. Response and progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up.~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|At baseline and every 8 weeks during treatment for a maximum of 12 cycles where one cycle equals 28 days.|Cohort results for this outcome measure are combined as the objective was to determine the tumor response of patients with this drug combination (dose was irrelevant)|||Participants|||Count of Participants
2830087|NCT00301067|Primary|Number of Patients With Toxicity|"Toxicity will be assessed for each patient on a seven-day on/seven-day off temozolomide in combination with high-dose calcitriol for every 2 weeks for up to 12 cycles where 1 cycle equals 28 days. Toxicity will be assessed during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) and defined by any toxicity determined to be at least possibly related to either study drug (temozolomide or calcitriol).~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~Grade 3 and grade 4 toxicities where relatedness to either study drug could not be ruled out were collected and recorded only."|From the start of treatment and every 2 weeks for a maximum of 12 cycles, and 30 days post last treatment, where 1 cycle equals 28 days|All patients that receive one dose of study drug were evaluable for this outcome measure.|||participants|||Number
2830088|NCT00301067|Primary|Number and Frequency of Dose Limiting Toxicities (DLTs) With High-dose Calcitriol in Combination With Temozolomide|"Determine number and frequency of dose limiting toxicities (DLT) of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 cycles of therapy, where 1 cycle equals 28 days.~3 patients per dose cohort will be entered into the trial at doses of 0.2, 0.3, and 0.5 mcg/kg of calcitriol administered orally. If 1 patient experiences dose limiting toxicity (DLT) at any dose, that dose cohort will be expanded to a maximum of 6 patients. If 1 additional patient experiences DLT at that dose stratum, further dose escalation will cease and the dose cohort immediately preceding the dose cohort where the 2 experiences of DLT occurred will be considered the MTD. If no additional patients experience DLT, dose escalation to the next higher dose stratum will take place.~DLT is defined as National Cancer Institute Common Toxicity Criteria, version 3.0 grade 3 toxicity determined to be related to calcitriol."|From start of treatment, up to 12 cycles where 1 cycle equals 28 days|1 patient enrolled in cohort 1 was not evaluable for this outcome measure as the patient only received 8 days of treatment. Patients enrolled in the expansion cohort were not evaluable for this outcome measure.|||DLT|||Number
2830089|NCT00301028|Primary|Number of Participants With Complete Response|Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.|Study period of 3 Years||||participants|||Number
2830090|NCT00300885|Secondary|Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)|Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of LCS Subscale based on the ITT population.|||Scores on a scale||Standard Deviation|Mean
2830091|NCT00300885|Secondary|Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)|"Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0=not at all to 4=very much). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation."|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of Total FACT-L based on the ITT population.|||Scores on a scale||Standard Deviation|Mean
2830478|NCT00297427|Secondary|Response to Booster Acupuncture if Needed|Change in the number of incontinent episodes per day following booster acupuncture|After the booster sessions|Participants who received booster acupuncture treatments during follow-up|||incontinent episodes/day||Standard Deviation|Mean
2830092|NCT00300885|Secondary|Duration of Response|Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of duration of response based on the ITT population.|||days||95% Confidence Interval|Median
2830093|NCT00300885|Secondary|Overall Best Response|Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of overall best response rate based on the ITT population.|||percentage of participants|||Number
2830094|NCT00300885|Secondary|Progression Free Survival (PFS)|PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|PFS (based on the ITT population) for subjects without disease progression/death at the time of analysis were censored at the last evaluation date. PFS for surviving subjects without post-baseline tumor assessments were censored at one day. In the case of an incomplete date (missing day), day 15 (the middle of the month) will be used.|||days||95% Confidence Interval|Median
2830095|NCT00300885|Primary|Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.|Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of OS based on the ITT population. Subjects alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, if the day is missing, day 15 (the middle of the month) will be used.|||days||95% Confidence Interval|Median
2830096|NCT00300781|Secondary|Duration of Response|Number of weeks between Complete Response (CR) or Partial Response (PR) and the first date of disease progression (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|From start date of response to first PD/death, up to 46 months|Subjects in Intent to Treat population with CR or PR|||weeks||95% Confidence Interval|Median
2830097|NCT00300781|Secondary|Clinical Benefit Rate|Percentage of participants who experienced Complete Response (CR), Partial Response (PR), or Stable Disease (SD) ≥ 24 weeks by independent assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From first dose date to progression or last tumor assessment, up to 46 months|Intent to Treat population|||percentage of participants||95% Confidence Interval|Number
2830098|NCT00300781|Secondary|Objective Response Rate|Percentage of participants with Partial Response (PR) or Complete Response (CR) by independent assessment of tumor per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From first dose date to progression or last tumor assessment, up to 46 months|Intent to Treat population|||percentage of participants||95% Confidence Interval|Number
2830099|NCT00300781|Primary|16-week Progression Free Survival|16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.|From first dose to 16 weeks|Intent to Treat Population|||percentage of participants||95% Confidence Interval|Number
2830100|NCT00300755|Secondary|"Number of Patients With Healed Erosive Esophagitis (EE) at End of Study"|Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).|8 weeks|The analysis population is randomized patients with erosive esophagitis at baseline.|||patients|||Number
2830101|NCT00300755|Secondary|Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline|Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question <3 times in a week.|||units on scale||Standard Deviation|Mean
2830102|NCT00300755|Secondary|Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week|Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease.|||units on scale||Standard Deviation|Mean
2830103|NCT00300755|Primary|Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)|WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.|Baseline and 8 weeks|The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period).|||units on scale||Standard Deviation|Mean
2830104|NCT00300742|Primary|Compliance With Study Requirements: Topiramate Level|Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day|up to 12 weeks|This is the number of participants who reached the dose of 300 mg of topiramate|||participants|||Number
2830105|NCT00300742|Primary|Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12|Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol|||Binge eating episodes/week||Standard Deviation|Mean
2830106|NCT00300742|Primary|Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12|Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol|||Mean percent days abstinent per week||Standard Deviation|Mean
2830107|NCT00300742|Primary|Mean Drinks Per Day at Baseline vs. Visit 12|Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary|up to 24 weeks|Per protocol|||Drinks/day||Standard Deviation|Mean
2830108|NCT00300742|Primary|Compliance With Study Requirements: Attendance at Treatment Sessions||up to 12 weeks||||participants|||Number
2830109|NCT00300677|Primary|Brain Concentrations of N-oxide Metabolite|Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
2830110|NCT00300677|Primary|Plasma Concentrations of N-oxide Metabolite|Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
2830111|NCT00300677|Primary|Brain Concentrations of Voriconazole|Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
2830112|NCT00300677|Primary|Plasma Concentrations of Voriconazole|Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).|||ng/mL||Standard Deviation|Mean
2830113|NCT00300495|Secondary|Length of Post-operative Hospital Stay|Length of hospital stay after the operation|1 week on average||||Days||Standard Deviation|Mean
2830114|NCT00300495|Primary|Incidence of Post-operative Atrial Fibrillation|Number of patients with post-operative atrial fibrillation|30 days||||Participants|||Count of Participants
2830115|NCT00300482|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF|||percent change||Inter-Quartile Range|Median
2830116|NCT00300482|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline ApoB and at least 1 postbaseline ApoB value, LOCF|||percent change||Standard Error|Mean
2830117|NCT00300482|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF|||percent change||Standard Error|Mean
2830118|NCT00300482|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF|||percent change||Standard Error|Mean
2830119|NCT00300482|Secondary|Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF|||percent change||Standard Error|Mean
2830120|NCT00300482|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward|||percent change||Standard Error|Mean
2830896|NCT00294658|Secondary|Number of Patients With at Least One Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years||||participants|||Number
2830121|NCT00300482|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward|||percent change||Standard Error|Mean
2830122|NCT00300482|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward|||percent change||Standard Error|Mean
2830123|NCT00300469|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF|||percent change||Inter-Quartile Range|Median
2830124|NCT00300469|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF|||percent change||Standard Error|Mean
2830125|NCT00300469|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF|||percent change||Standard Error|Mean
2830126|NCT00300469|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF|||percent change||Standard Error|Mean
2830127|NCT00300469|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF|||percent change||Standard Error|Mean
2830128|NCT00300469|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)|||percent change||Standard Error|Mean
2830129|NCT00300469|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbasline HDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)|||percent change||Standard Error|Mean
2830130|NCT00300469|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward (excluding one subject with an extreme outlying value)|||percent change||Standard Error|Mean
2830131|NCT00300456|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF|||percent change||Inter-Quartile Range|Median
2830132|NCT00300456|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF|||percent change||Standard Error|Mean
2830133|NCT00300456|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF|||percent change||Standard Error|Mean
2830134|NCT00300456|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF|||percent change||Standard Error|Mean
2830135|NCT00300456|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF|||percent change||Standard Error|Mean
2830136|NCT00300456|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward|||percent change||Standard Error|Mean
2830137|NCT00300456|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward|||percent change||Standard Error|Mean
2830138|NCT00300456|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward|||percent change||Standard Error|Mean
2830139|NCT00300430|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Full Range|Median
2830140|NCT00300430|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study||Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.|||percentage of participants|||Number
2830141|NCT00300430|Secondary|Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
2830142|NCT00300430|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
2830143|NCT00300430|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
2830144|NCT00300430|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study||Baseline to Week 52 in this open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
2830145|NCT00300430|Secondary|Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
2830146|NCT00300430|Secondary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Standard Deviation|Mean
2830147|NCT00300430|Secondary|Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.|||percent change||Full Range|Median
2830148|NCT00300391|Secondary|ICU Length of Stay||Daily|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||day||Inter-Quartile Range|Median
2830149|NCT00300391|Secondary|Duration of Mechanical Ventilation||daily|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||day||Inter-Quartile Range|Median
2830150|NCT00300391|Primary|90-day All-cause Mortality||90 Days from enrollment in study|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||Participants|||Count of Participants
2830151|NCT00300391|Primary|28-day All-cause Mortality||Daily|This study was pre-maturely terminated and although sincere efforts were made to locate the relevant and accurate data for results reporting, limited data could be obtained. Data are not available per-Arm (Haloperidol vs Placebo) for this Outcome Measure. The only available data are grouped by the “Delirium,” “Persistent Coma,” and “No delirium”.|||Participants|||Count of Participants
2830152|NCT00300365|Primary|Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks|Mean increase in HDL-C from baseline (week -4) to 12 weeks post randomization in non-diabetic subjects with low HDL-C and metabolic syndrome. After baseline, all subjects titrated niacin extended release (ER) to 2 grams (g) daily over 4 weeks. Subjects were also given 325 mg aspirin to take 30 minutes before the niacin ER. After 4 weeks, half of the subjects added blinded pioglitazone 30mg/day (milligrams/day) for 6 weeks followed by 45 mg/day for 6 weeks; the other half added placebo. HDL-C was was assessed at baseline and 12 weeks post randomization|Baseline, after 12 weeks of pioglitazone vs placebo|All subjects for whom HDL-C measurements were recorded at baseline (week -4) and 12 weeks post randomization to placebo, niacin ER, and aspirin or pioglitazone, niacin ER, and aspirin|||mg/dL||95% Confidence Interval|Mean
2830897|NCT00294658|Secondary|Number of Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years||||events|||Number
2830153|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2830154|NCT00300274|Secondary|Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R~C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|24 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.|||mL/min/1.73^2||Standard Deviation|Mean
2830155|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).|24 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2830156|NCT00300274|Secondary|Percentage of Participants With Composite Efficacy Failure at 24 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.~Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2830157|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment."|12 Months|Intent-to-treat population includes all randomized participants.|||Percentage of participants|||Number
2830158|NCT00300274|Secondary|Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12|Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.|12 Months|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).|||Percentage of participants|||Number
2830159|NCT00300274|Secondary|Change From Baseline in the Average Maximum Intimal Thickness at Month 12|Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.|Baseline, Month 12|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).|||mm||Standard Deviation|Mean
2830160|NCT00300274|Secondary|Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|12 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.|||mL/min/1.73^2||Standard Deviation|Mean
2830161|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).|12 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2830162|NCT00300274|Primary|Percentage of Participants With Composite Efficacy Failure at 12 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.~Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment."|12 Months|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2830163|NCT00300235|Secondary|Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol|Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.|Cross-sectional single survey visit|||||||
2830164|NCT00300235|Secondary|Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies|Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.|Cross-sectional single survey visit|||||||
2830165|NCT00300235|Secondary|Characterization of Priapism in Males With Sickle Cell Anemia With Reference to Time of Onset, Duration of Events, Frequency of Episodes, Precipitating or Associated Activities, Treatment Modalities Used, and Outcome of Treatments|Characterization of priapism in males with sickle cell anemia with reference to time of onset, duration of events, frequency of episodes, precipitating or associated activities, treatment modalities used, and outcome of treatments.|Cross-sectional single survey visit|||||||
2830166|NCT00300235|Primary|Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.|"Subject responded YES to survey Question Have you ever had priapism?. By diagnosis and age group. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia."|At time of interview|All particpants who completed survey were analyzed.|||participants|||Number
2830167|NCT00299988|Primary|CGIC|The Clinical Global Impression of Change focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. Unlike a targeted symptom scale, it takes into account a subject's overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. The CGIC range from 1 to 7, where 1=very much improved since the initiation of treatment; 4=no change from baseline; 7=very much worse since the initiation of treatment.|12 months||||units on a scale||95% Confidence Interval|Mean
2830168|NCT00299988|Primary|ADAS-Cog|"The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the gold standard for assessing antidementia treatments. The ADAS-Cog range from 0 to 70, where higher scores indicate greater cognitive dysfunction."|12 months||||units on a scale||95% Confidence Interval|Mean
2830169|NCT00299975|Secondary|Serum Glutamic Oxaloacetic Transaminase(SGOT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
2830170|NCT00299975|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
2830171|NCT00299975|Secondary|Blood Creatinine Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||μmol/L||Standard Deviation|Mean
2830172|NCT00299975|Secondary|Blood Urea Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||mmol/L||Standard Deviation|Mean
2830173|NCT00299975|Secondary|Adverse Effects (e.g. Renal and Liver Function Tests)||pre-treatment & post-treatment|||||||
2830174|NCT00299975|Secondary|Passing of Gas|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2830175|NCT00299975|Secondary|Sensation of Abdominal Pain/Cramping|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2830176|NCT00299975|Secondary|Sensation of Bloating|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2830177|NCT00299975|Secondary|Incomplete of Evacuation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2830178|NCT00299975|Secondary|Sensation of Straining|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2830179|NCT00299975|Secondary|Severity of Constipation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2830180|NCT00299975|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Week6, 10 & 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
2830181|NCT00299975|Secondary|Complete Spontaneous Bowel Movement (CSBM)|CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
2830182|NCT00299975|Secondary|Bowel Movement||Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
2830183|NCT00299975|Secondary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week11-18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
2830184|NCT00299975|Primary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week3-10|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
2830185|NCT00299741|Secondary|Objective Responses, Defined as the Number of Participants With Complete or Partial Response|The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.|Participants were followed until the time of disease progression, an average of 12 weeks||||participants|||Number
2830186|NCT00299741|Primary|The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)|were followed until disease progression, an average of 12 weeks|All participants analyzed|||participants|||Number
2830187|NCT00299702|Primary|Time in Remission|Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).|Day 1 to last PANSS measurement|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.|||days||Standard Deviation|Mean
2830188|NCT00299702|Primary|Time to Relapse|Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.|Day 1 to relapse|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.|||days||95% Confidence Interval|Median
2830189|NCT00299689|Secondary|Overall Survival||All cause mortality|||||||
2830190|NCT00299689|Primary|Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria||2 weeks after completion of second cycle||||participants|||Number
2830191|NCT00299546|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 24|Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.|From Baseline to Week 24|Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment.|||scores on a scale||Inter-Quartile Range|Median
2830192|NCT00299546|Secondary|American College of Rheumatology (ACR) 20 at Week 24|Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)|From Baseline to Week 24|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx.|||participants|||Number
2830193|NCT00299546|Secondary|Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14|DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders.|||participants|||Number
2830247|NCT00299416|Primary|Number of Participants With Catheter Related Complications During Hypothermia & Rewarming|Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.|over 36 hour period||||participants|||Number
2830194|NCT00299546|Secondary|American College of Rheumatology (ACR) 50 Response at Week 14|Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||participants|||Number
2830195|NCT00299546|Primary|American College of Rheumatology (ACR) 20 Response at Week 14.|ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||participants|||Number
2830196|NCT00299494|Secondary|Steady-state Volume (Vss) of Inotuzumab Ozogamicin Antibody Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Vss: Steady-state volume of distribution CL*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L||Geometric Coefficient of Variation|Geometric Mean
2830197|NCT00299494|Secondary|Clearance (CL) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Clearance defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK populatoin|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2830198|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830199|NCT00299494|Secondary|Average Serum Concentration (Cav) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830200|NCT00299494|Secondary|Time to Reach Maximum Concentration (Tmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830201|NCT00299494|Secondary|Peak Concentration (Cmax) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830202|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD+ Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58|AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830203|NCT00299494|Secondary|Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab on Dosing Day 30 and Day 58|"Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.~Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3."|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830204|NCT00299494|Secondary|Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830205|NCT00299494|Secondary|Area Under the Steady-state Concentration-time Curve (AUClast) of Serum Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830206|NCT00299494|Secondary|Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin Antibody in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m2 on Dosing Day 30 and Day 58|AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830207|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin+Rituximab on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830208|NCT00299494|Secondary|Time of Observed Maximum Concentration (Tmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin + Rituximab on Dosing Day 1, Day 30 and Day 58|Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830209|NCT00299494|Secondary|Peak Serum Concentration (Cmax) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830210|NCT00299494|Secondary|Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830211|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUClast) of Unconjugated Calicheamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830212|NCT00299494|Secondary|Serum Decay Half-Life (t1/2) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|"Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.~Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3."|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|Pk population|||hr||Full Range|Median
2830213|NCT00299494|Secondary|Mean Residence Time (MRT) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|MRT: AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Geometric Coefficient of Variation|Geometric Mean
2830214|NCT00299494|Secondary|Steady-state Volume (Vss) of Total Calicheamicin (Conjugated Plus Unconjugated) Distribution in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Vss: Steady-state volume of distribution CL*MRT of inotuzumab ozogamicin Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L||Geometric Coefficient of Variation|Geometric Mean
2830215|NCT00299494|Secondary|Clearance (CL) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Clearance defined as Dose/AUCinf. Corresponds to Dosing Day 30 for Cycle 2 and dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2830216|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Day 30 for Cycle 2; and Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830217|NCT00299494|Secondary|Average Serum Concentration (Cav) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cav: AUCtau/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830218|NCT00299494|Secondary|Time of Observed Maximum Concentration (Tmax) of Total Calicheamicin (Conjugated+Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|"Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence.~Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3."|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830219|NCT00299494|Secondary|Peak Serum Concentration (Cmax) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Cmax: Observed directly from data Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830220|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUCtau) for Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30, and Day 58|AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830221|NCT00299494|Secondary|Time of the Last Quantifiable Concentration in a Dosing Interval (Tlast) of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast: Time of last quantifiable concentration. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830248|NCT00299416|Secondary|Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay.|NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.|90 days|||||||
2830222|NCT00299494|Secondary|AUClast of Total Calicheamicin (Conjugated Plus Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|AUClast: AUC over dosage interval through last measurable time point, Tlast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||n*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830223|NCT00299494|Secondary|AUCinf of Total Calicheamicin (Conjugated + Unconjugated) in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|AUCinf: AUClast+(Clast/kel) where Clast is the predicted serum concentration at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830224|NCT00299494|Secondary|Serum Decay Half-Life (t1/2) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|"Termnial half-life (t½): Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.~Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3."|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830225|NCT00299494|Secondary|MRT of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|MRT: AUMCinf/AUCinf - DOF (degrees of freedom)/2, where AUMCinf is the area under the first moment curve derived using the linear/log trapezoidal method, and DOF is the duration of the IV infusion dose. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Geometric Coefficient of Variation|Geometric Mean
2830226|NCT00299494|Secondary|Steady-state Volume of Distribution (Vss) of Inotuzumab Ozogamicin in Serum in Participants Receiving Inotuzumab MTD+Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Vss of inotuzumab ozogamicin on Dosing Days 30 and 58 were reported. Vss=CL*MRT (mean residence time). Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L||Geometric Coefficient of Variation|Geometric Mean
2830227|NCT00299494|Secondary|Clearance (CL) of Serum Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58|Clearance is defined as Dose/AUCinf. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2830228|NCT00299494|Secondary|Minimum Observed Serum Trough Concentration (Cmin) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab+Rituximab on Dosing Day 30 and Day 58|Cmin: Lowest concentration observed during the dosing interval tau. Observed directly from data from Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830229|NCT00299494|Secondary|Average Serum Concentration at Steady State (Cav) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Cav: AUCtau (Area under the concentration time profile)/tau for Dosing Day 30 Cycle 2 and Dosing Day 58 Cycle 3. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830230|NCT00299494|Secondary|Time to Reach Maximum Concentration (Tmax) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tmax: Time at which Cmax occurs. Observed directly from data as time of first occurrence. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830231|NCT00299494|Secondary|Peak Serum Concentration (Cmax) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 were measured. Cmax of inotuzumab ozogamicin was reported. Cmax was observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2830232|NCT00299494|Secondary|Area Under the Steady-state Serum Concentration-time Curve (AUCtau) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Steady-state serum concentrations of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUCtau of inotuzumab ozogamicin was reported. AUCtau=AUC over dosage interval tau calculated using Linear/log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830233|NCT00299494|Secondary|Time of the Last Quantifiable Serum Concentration in a Dosing Interval (Tlast) of Inotuzumab Ozogamicin in Participants Receving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Tlast of inotuzumab ozogamicin on Dosing Days 1, 30, and 58 was reported. Tlast: Time of last quantifiable concentration of inotuzumab ozogamicin. Observed directly from data. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||hr||Full Range|Median
2830234|NCT00299494|Secondary|AUClast of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58|Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUC of inotuzumab ozogamicin was reported. AUClast is area under the serum concentration-time profile from time zero to the time of the Clast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.|Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population: all participants dosed with inotuzumab ozogamicin.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2830235|NCT00299494|Secondary|Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58|Serum concentration of inotuzumab ozogamicin on Dosing Days 30 and 58 were measured. AUCinf of inotuzumab ozogamicin was reported. AUCinf: AUClast (area under the serum concentration-time profile for inotuzumab ozogamicin from time zero to the time of the last quantifiable concentration) +(Clast [last quantifiable concentration]/kel [elimination rate constant]) where Clast is the predicted serum concentration of inotuzumab ozogamicin at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57 and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 30 for Cycle 2 and Dosing Day 58 for Cycle 3.|Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85|PK population|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2830236|NCT00299494|Secondary|Duration of Response (CR+CRu+PR)|Time from date measurement criteria met for CR, CRu, or PR (whichever occurred first) until first date relapsed disease/date of death. CR: Complete disappearance of all detectable clinical, radiographic evidence of disease, disease-related symptoms, normalization of NHL assignable biochemical abnormalities; lymph nodes, nodal masses regressed to normal size; spleen size regressed, not palpable on physical exam, size of other organs enlarged due to disease. CRu: CR but allows for: residual lymph node mass >1.5 cm in greatest transverse diameter that regressed >75% in product diameter. Individual nodes previously confluent, regressed by >75% in their product diameters; Indeterminate bone marrow. PR: ≥50% decrease in SPD of 6 largest dominant nodes/nodal masses; No increase in size of other nodes, liver, or spleen; Splenic/hepatic nodules regressed by ≥50% in SPD; Except splenic/hepatic nodules, involvement of other organs assessable and no measurable disease present.|Time from date measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the first date relapsed disease or date of death (whichever occurs first) is objectively documented.|ITT population. Calculated using Kaplan-Meier method using the number of participants that responded.|||Month||95% Confidence Interval|Median
2830237|NCT00299494|Secondary|Kaplan-Meier Estimates of the Probability of Being Event Free at 6 Months|Time-to-Tumor Progression (TTP): is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by >=50% in the size of previously involved sites, c. >= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. >= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determineTTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From enrollment to up to 6 months from 1st dose.|ITT population. Calculated using Kaplan-Meier method.|||Probability||95% Confidence Interval|Number
2830249|NCT00299416|Secondary|Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.||rewarming over 12 hours until 36.5C has been achieved|||||||
2830250|NCT00299416|Secondary|Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,|Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.|rewarming over 12 hours until 36.5C has been achieved|||||||
2830382|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 168|Biochemically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830238|NCT00299494|Secondary|Kaplan-Meier Estimates of Time to Tumor Progression (TTP)|TTP is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by >= 50% in the size of previously involved sites, c. >= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. >= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver. The Kaplan-Meier method was used to determine TTP. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From the date of first dose of test article until the first date on which disease progression or death was documented, any of which could be reported up to 5 years post last dose.|ITT population. Calculated using Kaplan-Meier method.|||Months||95% Confidence Interval|Median
2830239|NCT00299494|Secondary|Kaplan-Meier Estimates of the Probability of Survival at 6 Months|Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From the first dose to 6 months after first dose.|ITT population. Calculated using Kaplan-Meier method.|||Probability||95% Confidence Interval|Number
2830240|NCT00299494|Secondary|Kaplan-Meier Estimates of Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From the first dose up to 5 years post last dose|ITT population. Calculated using Kaplan-Meier method.|||Months||95% Confidence Interval|Median
2830241|NCT00299494|Secondary|Kaplan-Meier Estimates of the Probability of Being Progression Free at 6 Months|Progression Free Survival is defined as the time interval from the first dose of test article until the first date on which relapsed disease, progression, initiation of new anti-cancer treatment due to persistent/refractory disease, or death was documented, censored at the last tumor evaluation.|From the first dose to 6 months after first dose|ITT population; Calculated using Kaplan-Meier method.|||Probability||95% Confidence Interval|Number
2830242|NCT00299494|Secondary|Kaplan-Meier Estimates of Progression Free Survival (PFS)|The Kaplan-Meier method was used to determine PFS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by >= 50% in the size of previously involved sites, c. >= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. >= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spleen or liver.|From the date of first dose of test article until the first date on which disease progression or death was documented or new anticancer start, any of which could be reported up to 5 years post last dose|ITT population. Calculated using Kaplan-Meier method.|||Months||95% Confidence Interval|Median
2830243|NCT00299494|Secondary|Percentage of Participants With Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)|CR: a. Complete disappearance of all detectable clinical and radiographic evidence of disease, disease-related symptoms, and normalization of NHL assignable biochemical abnormalities ; b. lymph nodes and nodal masses must have regressed to normal size; c. Spleen regressed in size and not palpable on physical exam, size of other organs enlarged due to disease decreased in size; d. Repeat bone marrow infiltrate clear. CRu: CR but allows for a. Residual lymph node mass >1.5 cm in greatest transverse diameter has regressed by more than 75% in diameter. Individual nodes that were previously confluent regressed more than 75 % in their product diameters; b. Indeterminate bone marrow. PR: a. ≥50 % decrease in product of the diameters (SPD) of the 6 largest dominant nodes or nodal masses; b. No increase in size of other nodes, liver, or spleen, c. Liver or spleen nodules regressed ≥50% in the SPD; d. Other organs usually assessable, no measurable disease present.|Approximately every 2 (during treatment) or 3 (during follow-up) to 6 months for up to 5 years from 1st dose|ITT population: all participants enrolled into the intended dose scheme. Using exact method based on binomial distribution.|||Percentage of participants||95% Confidence Interval|Number
2830244|NCT00299494|Primary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|A TEAE is any event that occurred after the first dose of study drug up to 56 days post the last dose of study drug (either rituximab or inotuzumab ozogamicin).|Protocol reporting period of from informed consent to at least 28 days after the last dose. This outcome measure time frame: From the first dose of study drug to up to 56 days after the last dose of either study drug.|Safety population: All participants receiving at least 1 dose of inotuzumab ozogamicin or rituximab.|||Percentage of participants|||Number
2830245|NCT00299494|Primary|Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 )|Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, greater than 2 participants reporting DLT by Day 28 of first dose stop and prior dose level considered MTD. The worldwide medical monitor and investigators reviewed all significant study drug-related toxicities to determine if the dose escalation rules were satisfied and whether the dose escalation schedule required modification.|First 28-day cycle|Intent-To-Treat (ITT) Population: All participants included in the intended dose scheme. One additional participant was enrolled over the 6 planned participants in 1.8 mg/m^2 dose cohort because 1 participant was unevaluable for MTD evaluations.|||mg/m^2|||Number
2830246|NCT00299416|Primary|Number of Participants With Cardiorespiratory Failure|The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.|every 30 minutes during hypothermia induction||||participants|||Number
2830320|NCT00299000|Primary|Change in Haed Circumference||52 weeks||||centimeter||Standard Deviation|Mean
2830321|NCT00299000|Primary|Change in Weight||52 weeks||||kilograms||Standard Deviation|Mean
2830322|NCT00299000|Primary|Change in Height||52 weeks|Intention to treat.|||centimeters||Standard Deviation|Mean
2830251|NCT00299416|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage|Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)|from pre-dosage to 90 day followup|Number of participants were determined by intention to treat. We did not use any imputation technique.|||participants|||Number
2830252|NCT00299221|Secondary|Mean ISHLT Biopsy Score Over First Year Post-transplant|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|1 year|all pts, Intention to treat|||units on a scale||Standard Deviation|Mean
2830253|NCT00299221|Secondary|Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant|Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant|1 year|Percent of patients with allograft CAD at one year post-transplant|||patients|||Number
2830254|NCT00299221|Secondary|Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant|Number of patients developing cytomegalovirus disease by 1 year post-transplant|1 year|all patients|||participants|||Number
2830255|NCT00299221|Secondary|Percent of Patients Alive at One Year Post-transplant|Percent of patients alive at one year post-transplant. In other words, all cause mortality over time|1 year|all pts, intention to treat|||percent of participants|||Number
2830256|NCT00299221|Primary|Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|6 months|all pts, intention to treat|||units on a scale||Standard Deviation|Mean
2830257|NCT00299156|Primary|Participants With a Complete Remission (CR)|"Complete Remission (CR): Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L).~Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment.~Hematologic Improvement: meets all criteria for CR except for platelet recovery to >100 x 109/L.~Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 109/L."|After 3 courses of treatment, up to 24 weeks.||||Participants|||Number
2830258|NCT00299130|Post-Hoc|Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment|A low immunoglobulin concentration was defined as a concentration below the lower level of normal.|Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)|"Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. N indicates the number of participants with non-missing data at each time point."|||Percentage of participants|||Number
2830259|NCT00299130|Post-Hoc|Time to Repletion of Peripheral CD19+ B-cells|Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower.|Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)|Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period.|||Weeks||95% Confidence Interval|Median
2830260|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 48|"To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
2830261|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 48|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
2830262|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 48|Intent to treat population including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.|||percentage of participants|||Number
2830263|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher."|Baseline and Week 48|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.|||percentage of participants|||Number
2830264|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 48|Intent-to-treat population including participants with available data. LOCF was used.|||percentage of participants|||Number
2830265|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 24|Intent-to-treat population including participants with available data. LOCF was used.|||percentage of participants|||Number
2830266|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. Number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2830267|NCT00299130|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores|"The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830268|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830323|NCT00299000|Secondary|Change in Urinary Glycosaminoglycan Levels|Change in urinary GAG levels was calculated from baseline to week 52 of treatment.|minimum 52 weeks of dosing|Intention to treat.|||ug/mg creatinine||Standard Deviation|Mean
2830269|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830270|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830271|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830272|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830273|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830274|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830275|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."|||scores on a scale||Standard Deviation|Mean
2830276|NCT00299130|Secondary|Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A positive percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830277|NCT00299130|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate|"Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830278|NCT00299130|Secondary|Percent Change From Baseline in C-Reactive Protein|"C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830279|NCT00299130|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830280|NCT00299130|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity|"The physician's assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830281|NCT00299130|Secondary|Percent Change From Baseline in Patient's Pain Assessment|"The participant's assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as no pain and the right-hand extreme (100 mm) as unbearable pain.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830282|NCT00299130|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity|"The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830283|NCT00299130|Secondary|Percent Change From Baseline in Tender Joint Count|"Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830284|NCT00299130|Secondary|Percent Change From Baseline in Swollen Joint Count|"Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."|||percent change||Standard Deviation|Mean
2830285|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1."|Baseline and Week 24|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.|||percentage of participants|||Number
2830286|NCT00299130|Secondary|Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6."|Baseline and Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.|||scores on a scale||Standard Deviation|Mean
2830324|NCT00298896|Secondary|Best Overall Response|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started), classified as CR, PR, SD or PD per RECIST criteria.|upto 6 months|Efficacy Analysis Set|||Participants|||Count of Participants
2830287|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
2830288|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
2830289|NCT00299130|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24|"To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.|||percentage of participants|||Number
2830290|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 104|Participants from the Intent-to treat Population includes all randomized participants who received at least one dose of study drug with data at baseline and Week 104 available for analysis. Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2830291|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104|"Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.~No progression is defined as a change from score at screening to week 104 ≤0."|Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing.|||Percentage of Participants|||Number
2830292|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 104|Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 104|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing|||Percentage of Participants|||Number
2830293|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 104|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and who had both screening and post-baseline radiographic assessments at the given time point for analyses. Linear extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
2830294|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 104|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.|||Score on a scale||Standard Deviation|Mean
2830295|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Mental Health Component Score of >6.33.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.|||Percentage of Participants|||Number
2830296|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Physical Health Component Score of >5.42.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.|||Percentage of Participants|||Number
2830297|NCT00299104|Secondary|Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52|"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.~Improved:HAQ-DI score change <=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score => 0.22"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.|||Percentage of participants|||Number
2830298|NCT00299104|Secondary|Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Weeks 52, Week 104|"Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."|||Score on a scale||Standard Deviation|Mean
2830299|NCT00299104|Secondary|Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Week 52, Week 104|"Intent to treat (ITT) population includes all participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."|||Score on a scale||Standard Deviation|Mean
2830300|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 52|Intent-to treat Population includes all randomized participants who received at least one dose of study drug. Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2830325|NCT00298896|Primary|Objective Response Rate|Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR|up to 6 months|Efficacy Analysis Population|||Participants|||Count of Participants
2830301|NCT00299104|Secondary|Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Observed data.|||Score on a scale||Standard Deviation|Mean
2830302|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52|"To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
2830303|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52|"To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
2830304|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses.|||Percentage of Participants|||Number
2830305|NCT00299104|Secondary|The Percentage of Participants With Major Clinical Response at Week 52|"Major clinical response is defined as a continuous six-month period of success by the ACR70.~ACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion.|||Percentage of Participants|||Number
2830306|NCT00299104|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52|European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of > 1.2 compared with baseline, and attainment of a DAS28-ESR of < 3.2.|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing|||Percentage of Participants|||Number
2830307|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Remission at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Remission is defined as achieving a DAS28-ESR score of less than 2.6"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion with data available for analyses.|||Percentage of Participants|||Number
2830308|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52|"To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
2830309|NCT00299104|Secondary|Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52|"DAS28-ESR is calculated from the following formula:~(0.56 * TJC) + (0.28 * SJC) + (0.70 * ln ESR) + (0.014 * GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient's global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR < 2.6)."|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
2830310|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52|"To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).|||Percentage of Participants|||Number
2830311|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 24|Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 24|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing|||Percentage of Participants|||Number
2830312|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24|Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) with data available at Week 24 for analysis.|||Score on a scale||Standard Deviation|Mean
2830313|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 24|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) who had data available at Week 24 for analysis.|||Score on a scale||Standard Deviation|Mean
2830314|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 24|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 24|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time point for analysis.|||Score on a scale||Standard Deviation|Mean
2830315|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
2830316|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52|No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Percentage of Participants|||Number
2830317|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression at Week 52|Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) <= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.|||Percentage|||Number
2830318|NCT00299104|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
2830319|NCT00299104|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52|Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.|||Score on a scale||Standard Deviation|Mean
2830326|NCT00298831|Secondary|Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW)|General muscle weakness check was assessed by the investigator. The assessment of general muscle weakness was based on a scale from 0-10, with 0 representing total paralysis, 1 signifying extreme impairment, 9 for close to no impairment, and 10 for normal muscle strength. Scores of 3, 4, 5, etc. denoted increasing muscle strength in approximately 10% increments. Scores of 9 and lower were denoted as GMW. Assessment 1 occurred prior to transfer to the recovery room after extubation and assessment 2 occurred prior to discharge from the recovery room.|Up to 24 hours|The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint.|||Participants|||Count of Participants
2830327|NCT00298831|Secondary|Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL)|5-second head lift test was assessment of the ability of the participant to lift the head for 5 seconds and was performed by a blinded safety assessor. Tests were repeated every 15 minutes until the participant could successfully perform the 5-second head-lift. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.|Up to 24 hours|The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint.|||Participants|||Count of Participants
2830328|NCT00298831|Secondary|Clinical Assessment of Recovery - Participant's Level of Consciousness|The quality of recovery was assessed by asking the participant 40 questions from a validated Quality of Recovery Questionnaire (QoR-40). Participants were assessed for level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation), if applicable, by asking their name, if they are aware of where they are, and what day it is. Assessment 1 occurred prior to transfer to the recovery room after extubation and Assessment 2 occurred prior to discharge from the recovery room.|Up to 24 hours|The analysis population consisted of all participants who received investigational product and had at least one post baseline efficacy measurement for the analysis endpoint.|||Participants|||Count of Participants
2830329|NCT00298831|Secondary|Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8|"Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to approximately 15 minutes following administration of study treatment|The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.8 efficacy measurement.|||Minutes||Standard Deviation|Mean
2830330|NCT00298831|Secondary|Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7|"Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to approximately 10 minutes following administration of study treatment|The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.7 efficacy measurement.|||Minutes||Standard Deviation|Mean
2830331|NCT00298831|Primary|Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9|"Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to approximately 30 minutes following administration of study treatment|The analysis population consisted of all treated participants had at least one post baseline T4/T1 ratio to 0.9 efficacy measurement.|||Minutes||Standard Deviation|Mean
2830332|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination|Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
2830333|NCT00298766|Primary|Subjects Grade 3/4/5 Treatment Emergent Adverse Events|"Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame.~Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0."|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
2830334|NCT00298766|Primary|Subjects With Serious Treatment Emergent Adverse Events|Serious treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
2830350|NCT00298558|Secondary|Estimate the Effects of ACTIVE Training to General Population|To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.|10th Year|||||||
2830335|NCT00298766|Secondary|Best Confirmed Hematologic Responders|Hematologic response was determined by the investigator per the response criteria for immunoglobulin light chain amyloidosis by Gertz (2005). It include Complete and Partial Responders (CR+PR). CR requires serum and urine negative for a monoclonal protein by immunofixation and free light chain ratio normal. PR requires: 1. reduction in quantitative serum M-protein by 50% if baseline value is at least 0.5 g/dL, 2. if light chain is detected in the urine (with a consistent peak and >100 mg/ 24 hours), then 50% reduction is required, 3. if free light chain >10 mg/dL, reduction by 50% is required.|from first dose of study medication to end of study visit|Efficacy population included all treated subjects with an evaluable post baseline resposne assessment in the MTD cohorts (1.6 mg/m^2 QW and 1.3 mg/m^2 BIW).|||participants responded|||Number
2830336|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population|||participants|||Number
2830337|NCT00298766|Primary|Maximum Tolerated Dose|"Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts.~DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity."|5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts|Phase 1 Safety Population includes all subjects who received at least one dose of VELCADE in phase 1 dose escalation cohorts|||participants with DLT|||Number
2830338|NCT00298740|Primary|Glucose Control as Assessed by Mean Glucose Levels||End of study, approximately 5 years|It is unclear whether data was collected. No data is available and exhaustive searching has yielded no person with historical knowledge of this study or access to any data. Information obtained in other sections was from Regulatory records retrieved from long-term storage. This study closed in 2009 and the Principal Investigator is deceased.||||||
2830339|NCT00298610|Secondary|Safety - Serious Adverse Event (SAE) Relationship to Study Drug|Determine the safety (defined as relationship to study drug of SAE's)|Up to 14 days||||Number of events|||Number
2830340|NCT00298610|Secondary|Safety - Severity of Serious Adverse Events (SAE's)|Determine the safety (defined as severity of SAE's using the Common Toxicity Criteria)|up to 14 days||||Number of events|||Number
2830341|NCT00298610|Secondary|Safety - Adverse Events Relationship to Study Drug|Determine the safety (defined as relationship to study drug of AE's and SAE's)|up to 14 days||||Number of adverse events|||Number
2830342|NCT00298610|Secondary|Safety - Severity of Adverse Events|Determine the safety (defined as severity of AE's using the Common Toxicity Criteria)|up to 14 days||||Number of adverse events|||Number
2830343|NCT00298610|Secondary|Number of Subjects With Fever Clearance|Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (<37.5C) sustained for 24 hours|Within 48 hours post dose|Summary of subject with fever clearance, defined as first sustained absence of fever (<37.5C for least 24 hours)|||Participants|||Count of Participants
2830344|NCT00298610|Secondary|Percentage of Parasite Clearance|The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears|24 and 48 hours post dose|Percentage of parasite clearance within the first 24 and 48 hours post dose of intravenous artesunate|||percentage of parasite clearance||Standard Deviation|Mean
2830345|NCT00298610|Primary|Change in Percentage of Parasites Detected at 48 Hours|Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases|48 hours|Percentage of parasite change at 48 hours post dose|||percentage of parasite change||Standard Deviation|Mean
2830346|NCT00298558|Primary|Changes in Everyday Speed of Processing From Baseline to Year 10|"Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
2830347|NCT00298558|Primary|Changes in Everyday Problem Solving From Baseline to Year 10|"Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
2830348|NCT00298558|Primary|Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10|"The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
2830349|NCT00298558|Primary|Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10|"Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
2830351|NCT00298558|Primary|Changes in Cognitive Abilities of Reasoning From Baseline to Year 10|"Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
2830352|NCT00298558|Secondary|Examine Health, Genetic and Cognitive Moderators|To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.|10th Year|||||||
2830353|NCT00298558|Secondary|Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use|To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.|10th Year|||||||
2830354|NCT00298558|Primary|Changes in Cognitive Abilities of Memory From Baseline to Year 10|"Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.|||units on a scale||Standard Deviation|Mean
2830355|NCT00298389|Primary|Phagocytosis of S. Pneumoniae Concentration|Measurement of phagocytosis in vitro, Phagocytosis of S. pneumoniae concentration|1 hour||||relative fluescence||Standard Error|Mean
2830356|NCT00298389|Primary|Phagocytosis of H. Influenzae Concentration|Measurement of phagocytosis in vitro, Phagocytosis of H. influenzae concentration|1 hour||||relative fluorescence unit||Standard Error|Mean
2830357|NCT00298363|Secondary|In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results||Baseline to Week 168|Liver transplantation analysis set|||Days|||Number
2830358|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830359|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830360|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830361|NCT00298363|Primary|Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL|Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.|Baseline to Week 168|Full analysis set|||percent probability (KM estimate)||95% Confidence Interval|Number
2830362|NCT00298363|Other Pre-specified|Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with both ADV and LAM resistance mutations at baseline were included in this analysis.|||percentage of participants|||Number
2830363|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Patients in the full analysis set with LAM resistance mutation at baseline were included in this analysis.|||percentage of participants|||Number
2830364|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with ADV resistance mutation at baseline were included in this analysis.|||percentage of participants|||Number
2830365|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830366|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 168|Serologically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830367|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 144|Serologically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830368|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 96|Serologically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830369|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 48|Serologically evaluable analysis set (subjects in full analysis set with positive hepatitis B early antigen [HBeAg] at baseline); noncompleters/switch = failure|||percentage of participants|||Number
2830370|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 168|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 168|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
2830371|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 144|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 144|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
2830372|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 96|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 96|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
2830373|NCT00298363|Secondary|Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 48|Subjects in the full analysis set with an available score at the visit|||units on a scale||Inter-Quartile Range|Median
2830374|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|CPT evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830375|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|CPT evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830376|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|CPT evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830377|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|CPT evaluable analysis set (subjects with CPT scores ≥ 7 at baseline; because the minimum CPT score was 5, only these subjects were evaluable for analyses of ≥ 2-point decrease in CPT score); noncompleters/switch = failure|||percentage of participants|||Number
2830378|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830379|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830380|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830381|NCT00298363|Secondary|Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830406|NCT00298233|Secondary|In-hospital Mortality Rates|Standard therapy with oseltamivir is five days. Those patients with persistent symptoms on day five were continued on the randomized dose for an additional five days and assessments were performed up to day 10.|After up to 10 days of treatment||||participants|||Number
2830383|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 144|Biochemically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830384|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 96|Biochemically evaluable analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830385|NCT00298363|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48|Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 48|Biochemically evaluable analysis set (subjects in full analysis set with abnormal baseline alanine aminotransferase [ALT] values); noncompleters/switch = failure|||percentage of participants|||Number
2830386|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.|Week 168|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830387|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.|Week 144|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830388|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.|Week 96|Full analysis set; noncompleters/switch = failure|||percentage of participants|||Number
2830389|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.|Week 48|Full analysis set; noncompleters/switch = failure analysis (participants who did not complete treatment or changed from double-blind to open-label treatment up to the time point were considered as failing to meet efficacy response criteria [defined as not achieving viral suppression of < 400 copies/mL]).|||percentage of participants|||Number
2830390|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 168 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 168 were excluded.|||log_10 copies/mL||Inter-Quartile Range|Median
2830391|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 144 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 144 were excluded.|||log _10 copies/mL||Inter-Quartile Range|Median
2830392|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 96 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 96 were excluded.|||log_10 copies/mL||Inter-Quartile Range|Median
2830393|NCT00298363|Secondary|Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 48 weeks|Participants with HBV DNA measurements at Week 48 were included in this analysis.|||log_10 copies/mL||Inter-Quartile Range|Median
2830394|NCT00298363|Primary|Percent Probability of Tolerability Failure|Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.|Baseline to Week 168|Full analysis set (all randomized subjects who received at least one dose of study drug)|||percent probability (KM estimate)||95% Confidence Interval|Number
2830395|NCT00298272|Primary|Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings|The following immunological assessments were conducted: autoantibody concentrations for RF, anti-cyclic-citrullinated peptide (CCP) antibody concentrations, quantitative immunoglobulin levels, and lymphocyte assessments of T- and B-cell populations, determined using whole blood expanded fluorescent-activated cell sorter (FACS) analysis. The following laboratory assessments were performed: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC) with differential, and platelet counts; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, total bilirubin, blood urea nitrogen (BUN), uric acid, creatinine, random glucose, potassium, sodium, chloride, calcium, and phosphorous; blood, protein, and glucose (microscopic examination, if abnormal and applicable).|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||participants|||Number
2830431|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II Total Score at Week 12|Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
2830396|NCT00298272|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24|An AE was any sign (including an abnormal laboratory result that the investigator determined to be clinically significant), symptom, or diagnosis/disease that is unfavorable or unintended, that was new, or if pre-existing, worsened in a participant and that did not necessarily have a causal relationship with the treatment. An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||participants|||Number
2830397|NCT00298272|Primary|Maximum Duration of Infections Through Week 24|"Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). For participants with multiple infections, only the infection with the longest duration was included in this analysis."|Week 24|Participants in the Safety Population with at least 1 infection. The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||days||Standard Deviation|Mean
2830398|NCT00298272|Primary|Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24|"Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). Participants with multiple infections were calculated only once. The severity of all reported adverse events, including infections, was graded and reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events. This scale defines the severity of an adverse event as follows: Grade 1 = a mild adverse event, Grade 2 = a moderate adverse event, Grade 3 = a severe adverse event, and Grade 4 = a life-threatening or disabling adverse event."|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||participants|||Number
2830399|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24|An ACR70 response is defined as a 70% reduction in the number of both swollen and tender joints, and a 70% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.|||proportion of participants|||Number
2830400|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24|An ACR50 response is defined as a 50% reduction in the number of both swollen and tender joints, and a 50% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.|||proportion of participants|||Number
2830401|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24|An ACR20 response is defined as a 20% reduction in the number of both swollen and tender joints, and a 20% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.|||proportion of participants|||Number
2830402|NCT00298272|Primary|Proportion of Participants With at Least One Serious Infection Through Week 24|An infection was considered serious if it required intravenous (IV) antibiotics or met the regulatory definition of a serious adverse event (SAE). An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.|||proportion of participants|||Number
2830403|NCT00298233|Secondary|Median Time (Days) on Ventilation|Use of mechanical ventilation at any time for subjects with severe influenza and avian influenza.|Throughout study, 14 days||||days||95% Confidence Interval|Median
2830404|NCT00298233|Secondary|Median Time (Days) in ICU||Throughout study, 14 days||||days||95% Confidence Interval|Median
2830405|NCT00298233|Secondary|Median Time (Days) Receipt of Oxygen||Throughout study, 14 days||||days||95% Confidence Interval|Median
2830407|NCT00298233|Secondary|Participants Meeting Criteria for Day 5 Clinical Failure|"Proportion of participants that have clinical failure by day 5. Subjects that meet one of the following on Day 5 will be classified as a clinical failure:~Severe tachypnea (respiratory rate ≥ 30 for ages ≥12 years, rate ≥ 40 for ages 6 to 12 years, rate ≥45 for ages 3 to 6 years, rate ≥ 50 for ages 1 to 3 years)~Severe dyspnea (unable to speak full sentences, or use of accessory respiratory muscles)~Arterial oxygen saturation ≤92% on room air by trans-cutaneous method~Need for mechanical ventilation or intensive care unit (ICU) admission For the purpose of endpoint definition, death prior to or on Day 5 will also be considered a clinical failure at Day 5."|After 5 days of treatment|For the purpose of endpoint definition, death prior to or on Day 5 was also considered as clinical failure on day 5.In the double dose cohort, only 154 subjects completed fives days of drug and 7 died (total 161). In the standard dose cohort only 149 subjects completed 5 days of drug and 9 died (total 158).|||participants|||Number
2830408|NCT00298233|Primary|Proportion of All Participants Negative for Viral RNA on Day 5|Proportion of all participants with no detectable viral RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) in a combined nasal and throat swab sample on day 5.|After 5 days of treatment|All randomized patients with RT-PCR proven influenza.|||participants|||Number
2830409|NCT00298155|Secondary|To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT|Serum DHT|After 12 weeks of neoadjuvant androgen deprivation|Patients with clinically localized prostate cancer treated for 3 months with the treatments in Groups 1-3|||ng/dL||Standard Deviation|Mean
2830410|NCT00298155|Primary|Prostate Tissue DHT|Tissue dihydrotesterone (DHT)|After 12 weeks of neoadjuvant androgen deprivation||||ng/g||Standard Deviation|Mean
2830411|NCT00298090|Primary|Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line|Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.|up to 15 minutes|Data from 18 subjects not used due to only partial data captured resulting from logistical issues.|||StO2 percent saturation||95% Confidence Interval|Mean
2830412|NCT00298038|Secondary|Mean Change From Baseline In Venous Ammonia Concentration At End Of Treatment|Venous blood samples (10 mL) were collected at Baseline/Randomization (Day 0) and Days 28, 84, and 168. Baseline value was the last available value prior to first dose of study drug, and end of treatment value was the last available post-baseline value during the treatment period.|Baseline, Month 6 (End Of Treatment)|Randomized participants who received at least 1 dose of study drug (ITT population) with evaluable venous ammonia data.|||microgram per deciliter (ug/dL)||Standard Deviation|Mean
2830413|NCT00298038|Secondary|Mean Change From Baseline In Fatigue Domain Score On The CLDQ At End Of Treatment|The 29-item Chronic Liver Disease Questionnaire (CLDQ) questionnaire consists of the following domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry. Participants ranked their level of fatigue by using a 7-point scale from the worst response (1, high degree of fatigue) to the best response (7, minimal fatigue).|Baseline, 6 months (End Of Treatment)|Randomized participants who received at least 1 dose of study drug (ITT population) and able to complete the questionnaire at the applicable time point.|||score on a scale||Standard Deviation|Mean
2830414|NCT00298038|Secondary|Time To Any Increase From Baseline In Asterixis Grade|Time to any increase in asterixis grade was computed as the number of days from the first dose of study drug to the initial occurrence of an increase from baseline in asterixis grade. Asterixis (flapping tremor) was determined with the participant holding both arms and forearms extended with wrists dorsiflexed and fingers open for ≥30 seconds per standard practice. Asterixis grade range: Grade 0 (no abnormal movement) to Grade 4 (almost continuous flapping motions). Participants who discontinued prior to experiencing an increase in asterixis grade and prior to completion of the 6-month treatment period were censored at the time of discontinuation. The number of events of the initial occurrence of an increase from baseline in asterixis grade during the treatment interval is presented.|Baseline up to 6 months|Randomized participants who received at least 1 dose of study drug (ITT population). Assuming censored cases were at risk for half of the interval for onset of breakthrough HE episode, the censored cases only counted for half in figuring number at risk. Numbers at risk were rounded up to whole integers.|||events|||Number
2830415|NCT00298038|Secondary|Time To Any Increase From Baseline In Conn Score|Time to any increase in Conn score (mental state grade) was computed as the number of days from the first dose of study drug to the initial occurrence of an increase from baseline in Conn score. Conn score range: Grade 0 (no behavioral abnormality) to Grade 4 (coma; unable to test mental state). Participants who discontinued prior to experiencing an increase in Conn score and prior to completion of the 6-month treatment period were censored at the time of discontinuation. The number of events of the initial occurrence of an increase from baseline in Conn score during the treatment interval is presented.|Baseline up to 6 months|Randomized participants who received at least 1 dose of study drug (ITT population). Assuming censored cases were at risk for half of the interval for onset of breakthrough HE episode, the censored cases only counted for half in figuring number at risk. Numbers at risk were rounded up to whole integers.|||events|||Number
2830416|NCT00298038|Secondary|Time To First HE-related Hospitalization|Time to first HE-related hospitalization is defined as the duration (number of days) between the first dose of study drug and the date of first HE-related hospitalization. Participants who discontinued prior to hospitalization due to HE and prior to completion of the 6-month treatment period were censored at the time of discontinuation. The number of participants with their first HE-related hospitalization per interval is presented. The number of events of the first HE-related hospitalization during the treatment interval is presented.|Baseline up to 6 months|Randomized participants who received at least 1 dose of study drug (ITT population). Assuming censored cases were at risk for half of the interval for onset of breakthrough HE episode, the censored cases only counted for half in figuring number at risk. Numbers at risk were rounded up to whole integers.|||events|||Number
2830432|NCT00297778|Secondary|Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12|The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Inter-Quartile Range|Median
2830417|NCT00298038|Primary|Time To The First Breakthrough Overt HE Episode|Time to a breakthrough overt HE episode was the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. A breakthrough overt HE episode was defined as an increase of Conn score from Grade 0 or 1 to ≥2, or an increase in Conn and asterixis score of 1 grade each for those participants who entered the study with a Conn score of 0. Participants who completed the study and did not experience a breakthrough overt HE episode were censored at the time of their 6-month visit. Participants who terminated early for reasons other than a breakthrough overt HE episode were contacted at 6 months from randomization to determine if they had experienced a breakthrough overt HE event or other outcome. Participants without breakthrough overt HE were censored at the time of last contact or death, whichever was earlier. The number of events of a first breakthrough overt HE episode during the treatment interval is presented.|Baseline up to 6 Months (168 days)|Randomized participants who received at least 1 dose of study drug (ITT population). Assuming censored cases were at risk for half of the interval for onset of breakthrough HE episode, the censored cases only counted for half in figuring number at risk. Numbers at risk were rounded up to whole integers.|||events|||Number
2830418|NCT00297830|Secondary|Serum N-telopeplide Percent Change||24 months|Serum n-telopeplide percent change was not collected.||||||
2830419|NCT00297830|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months||||percent change||95% Confidence Interval|Mean
2830420|NCT00297830|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months||||percent change||95% Confidence Interval|Mean
2830421|NCT00297830|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months||||percent change||95% Confidence Interval|Mean
2830422|NCT00297778|Secondary|Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs||Baseline and Week 12||||participants|||Number
2830423|NCT00297778|Secondary|Change From Baseline in the UPDRS Part IV Total Score at Week 12|The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
2830424|NCT00297778|Secondary|Change From Baseline in the UPDRS Part I Total Score at Week 12|The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Inter-Quartile Range|Median
2830425|NCT00297778|Secondary|Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12|The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).|Baseline and Week 12|FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.|||mm||Standard Error|Least Squares Mean
2830426|NCT00297778|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12|This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Week 12|FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.|||units on a scale||Inter-Quartile Range|Median
2830427|NCT00297778|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Week 12|FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.|||units on a scale||Inter-Quartile Range|Median
2830428|NCT00297778|Secondary|Clinical Global Impressions of Global Improvement (CGI-I) at Week 12|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)|Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.|||units on a scale||Full Range|Median
2830429|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II+III Total Score at Week 12|The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
2830430|NCT00297778|Secondary|Change From Baseline in the UPDRS Part III Total Score at Week 12|The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.|||units on a scale||Standard Error|Least Squares Mean
2830433|NCT00297778|Secondary|Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12|The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.|||units on a scale||Inter-Quartile Range|Median
2830434|NCT00297778|Secondary|Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12|The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.|||units on a scale||Standard Error|Least Squares Mean
2830435|NCT00297778|Secondary|Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12|BDI clinical response was defined as a reduction of ≥50% from baseline|Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).|||participants|||Number
2830436|NCT00297778|Primary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Week 12|The Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data.|||Score on scale||Standard Error|Least Squares Mean
2830437|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
2830438|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
2830439|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
2830440|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
2830441|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease|Week 10|Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
2830442|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
2830443|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
2830444|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.|||Pearson Correlation Coefficient||95% Confidence Interval|Number
2830445|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52|The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.|Baseline, Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.|||ratio||Full Range|Geometric Mean
2830446|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52||Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.|||mg/L||Full Range|Geometric Mean
2830447|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10|Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.|||ratio||Full Range|Geometric Mean
2830448|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10||Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.|||mg/L||Full Range|Geometric Mean
2830449|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830450|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830451|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830452|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10|Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830453|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment|The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
2830454|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.|||score on a scale||Standard Deviation|Mean
2830455|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830456|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830457|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830458|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830459|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830460|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830461|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830462|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||Score on a scale||95% Confidence Interval|Mean
2830463|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830464|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100|||percentage of patients||95% Confidence Interval|Number
2830477|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 1 week post true or sham acupuncture||||seconds||Standard Deviation|Mean
2830465|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830466|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830467|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830468|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830469|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830470|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830471|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.|||percentage of patients||95% Confidence Interval|Number
2830472|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.|||score on a scale||95% Confidence Interval|Mean
2830473|NCT00297596|Secondary|Time to Progression||18 months|||||||
2830474|NCT00297596|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|18 months||||percentage of participants||95% Confidence Interval|Number
2830475|NCT00297492|Primary|Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement|Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million|6 months|This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.|||participants|||Number
2830476|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 4 weeks post true or sham acupuncture||||seconds||Standard Deviation|Mean
2830479|NCT00297427|Secondary|Need for Booster Acupuncture During Follow-up|The number of participants who were received true acupuncture (as their initial intervention or after initially receiving sham acupuncture) and were eligible to receive a booster (had a 50% or greater reduction in incontinent episodes following true acupuncture) and completed at least one month of follow-up and experienced a 30% or greater increase in incontinent episodes during follow up.|Monthly during the 6 month follow-up period|Participants who completed true acupuncture (as either their initial treatment or following sham acupuncture), had a 50% or greater reduction in incontinent episodes at 1 or 4 weeks post-true acupuncture, and completed at least one month of follow-up.|||participants|||Number
2830480|NCT00297427|Secondary|Burden Associated With the Acupuncture Treatment Protocol|Subjects' report of burden (difficulty) associated with the frequency, number and duration of treatment) and the position they had to remain in during the true and sham treatments. Subjects rate the difficulty associated with each of the four aspects of treatment on a 10-point scale ranging from 1 (not at all difficult) to 10 (extremely difficult). The burden score was calculated as the average of the scores on the 4 items with a possible range of 1 to 10 with higher scores indicating greater burden.|1 week post-treatment|The number of participants analyzed for this outcome was only those who completed the treatment protocol and the 1-week post-treatment visit. For this reason, the number is smaller than the number for the primary outcomes|||units on a scale||Inter-Quartile Range|Median
2830481|NCT00297427|Secondary|Adherence to Treatment Protocol|Percentage of acupuncture (true or sham) visits completed as scheduled|6 weeks|True and sham acupuncture subjects who completed the 6 weeks of treatment; participants who dropped out of the study during treatment were not included in this analysis|||percent of visits||Standard Deviation|Mean
2830482|NCT00297427|Secondary|Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years|Duration of urinary incontinence in years|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)|||years||Standard Deviation|Mean
2830483|NCT00297427|Secondary|Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)|Glasses/cups per day of non-caffeinated fluids (including water) at baseline|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)|||Glasses/cups per day||Standard Deviation|Mean
2830484|NCT00297427|Secondary|Urodynamic Impression of Urge Urinary Incontinence|Documentation of a diagnostic impression of urge urinary incontinence following urodynamics|Baseline and 4 weeks post true or sham acupuncture||||participants|||Number
2830485|NCT00297427|Secondary|Urodynamic Diagnostic Impression of Stress Urinary Incontinence|Documentation of a diagnostic impression of stress urinary incontinence following urodynamics|Baseline and 4 weeks post-treatment||||participants|||Number
2830486|NCT00297427|Secondary|Change in Bladder Capacity|Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.|Change from baseline to 4 weeks post-intervention|Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture.|||milliliters||Standard Deviation|Mean
2830487|NCT00297427|Primary|Duration of Any Beneficial Effects|Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)|monthly during follow-up up to 6 months|Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture|||Months||Standard Error|Mean
2830488|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.|4-weeks post-intervention|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Mean
2830489|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.|1 Week post-intervention|Intention-to-treat analysis|||percentage change relative to baseline||Inter-Quartile Range|Median
2830490|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.|4 weeks post true or sham acupuncture|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Median
2830491|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.|1 week post-intervention|Intention to treat analysis|||percentage change relative to baseline||Inter-Quartile Range|Median
2830492|NCT00297427|Primary|Physical Health-Related Quality of Life|Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.|4-weeks post-intervention|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Median
2830493|NCT00297427|Primary|Physical Health-Related Quality of Live|Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.|1 Week post-intervention|Intention-to-treat|||percentage change relative to baseline||Inter-Quartile Range|Median
2830494|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture|4 weeks post true or sham acupuncture|Intention-to-treat analysis|||percent change in incontinent episodes||Standard Deviation|Mean
2830677|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830495|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.|Baseline to 1 Week post-intervention|Intention-to-treat|||percent change in incontinent episodes||Standard Deviation|Mean
2830496|NCT00297258|Secondary|Overall Response|Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a >=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.|Baseline until either response or progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||participants|||Number
2830497|NCT00297258|Secondary|Progression Free Survival|Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.|Start of therapy until progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||years||90% Confidence Interval|Median
2830498|NCT00297258|Secondary|Overall Survival|Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.|Start of therapy until death (up to approximately 5 years)|ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||years||90% Confidence Interval|Median
2830499|NCT00297258|Primary|Progression Free Survival at Week 12|Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a >=20% increase in target lesions.|Week 12|Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken >=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.|||participants|||Number
2830500|NCT00297232|Primary|Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0|Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.|Up to 480 weeks|Participants with EDSS improvement (regardless of length of follow-up) sustained for 24 weeks.|||weeks||Inter-Quartile Range|Median
2830501|NCT00297232|Primary|Time to 48-week Confirmed EDSS Progression|Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 48 weeks.|||weeks||Inter-Quartile Range|Median
2830502|NCT00297232|Primary|Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression|Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 24 weeks.|||weeks||Inter-Quartile Range|Median
2830503|NCT00297167|Other Pre-specified|Percentage of Stools With Blood|Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||percentage of stools with blood per day||Standard Deviation|Mean
2830504|NCT00297167|Other Pre-specified|Percentage of Visible Oil or Grease in Stool|Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||percentage of visible oil or grease/day||Standard Deviation|Mean
2830517|NCT00297115|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
2830505|NCT00297167|Secondary|Mean Number of Abdominal Symptoms|Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||symptoms per day||Standard Deviation|Mean
2830506|NCT00297167|Secondary|Percentage of Stool Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||percentage of stools||Standard Deviation|Mean
2830507|NCT00297167|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.|||stools per day||Standard Deviation|Mean
2830508|NCT00297167|Secondary|Vitamin E Levels|Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||mg/L||Standard Deviation|Mean
2830509|NCT00297167|Secondary|Vitamin A Levels|Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||microgram per liter (mcg/L)||Standard Deviation|Mean
2830510|NCT00297167|Secondary|Lipid Levels|Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specific time point in each treatment arm."|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2830511|NCT00297167|Secondary|Percent Coefficient of Nitrogen Absorption (CNA%)|Percent CNA was calculated as ([nitrogen intake-nitrogen excretion]/nitrogen intake)*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||percent CNA||Standard Error|Least Squares Mean
2830512|NCT00297167|Primary|Percent Coefficient of Fat Absorption (CFA%)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."|||percent CFA||Standard Error|Least Squares Mean
2830513|NCT00297115|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
2830514|NCT00297115|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.|||mg/L||95% Confidence Interval|Least Squares Mean
2830515|NCT00297115|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.|||days||Standard Deviation|Mean
2830516|NCT00297115|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2830518|NCT00297115|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2830519|NCT00297102|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||scores on a scale||Standard Error|Least Squares Mean
2830520|NCT00297102|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.|||mg/L||95% Confidence Interval|Least Squares Mean
2830521|NCT00297102|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.|||days||Standard Deviation|Mean
2830522|NCT00297102|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2830523|NCT00297102|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
2830524|NCT00297102|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.|||mL||Standard Error|Least Squares Mean
2830525|NCT00297037|Secondary|The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.|Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.|0, 1, 2, 4, 6 weeks||||mm||Full Range|Mean
2830526|NCT00297037|Secondary|The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).|The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks||||units on a scale||Full Range|Mean
2830527|NCT00297037|Primary|The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.|The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks|ITT using last observation carried forward for missing data|||units on a scale||Full Range|Mean
2830528|NCT00296816|Secondary|Median Overall Survival Time|"Survival was the observed length of life from entry into the study to death or the date of last contact.~The median overall survival time was estimated using Kaplan-Meier Curve."|up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||days||90% Confidence Interval|Median
2830529|NCT00296816|Secondary|Overall Survival Rate|"Survival was the observed length of life from entry into the study to death or the date of last contact.~The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here."|up to up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||percentage of participants||95% Confidence Interval|Number
2830530|NCT00296816|Secondary|CA-125 Response Rate|"A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days.~The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup."|up to 12 months after treatment initiation|All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment.|||percentage of participants||95% Confidence Interval|Number
2830539|NCT00296647|Primary|6 Month Self-reported Abstinence From Smoking|Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)|6 months|intent to treat|||participants|||Number
2830651|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 52 [LOCF]||||ratio||95% Confidence Interval|Geometric Mean
2830531|NCT00296816|Secondary|Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline|"The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.~Participants were~censored on the last available CA 125 biomarker blood draw date if~left the study prior to disease progression or death~they received off-study anti-tumor medication~underwent debulking surgery~censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw."|up to approximately 1500 days following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.|||days||95% Confidence Interval|Median
2830532|NCT00296816|Secondary|Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline|"Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died.~Disease progression included the following:~the appearance of a new lesion~symptomatic deterioration~progression of non-target lesions~a predefined serum CA 125 increase.~RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS."|up to 12 months following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.|||percentage of participants||95% Confidence Interval|Number
2830533|NCT00296816|Secondary|Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)|"Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which:~Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions~Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions~Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||participants|||Number
2830534|NCT00296816|Secondary|Median Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.~Time of PFS was censored~on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery),~at Day 1, for living participants with no post-baseline tumor assessments.~Median PFS was estimated from a Kaplan-Meier curve."|up to approximately 1300 days following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||days||95% Confidence Interval|Median
2830535|NCT00296816|Secondary|Twenty Four-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).~Disease progression was recorded as any one of the following:~appearance of a new lesion~symptomatic deterioration~progression of target or nontarget lesions~death~Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 24 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||percentage of participants||95% Confidence Interval|Number
2830536|NCT00296816|Primary|Twelve-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).~Disease progression was recorded as any one of the following:~appearance of a new lesion~symptomatic deterioration~progression of target or nontarget lesions~death~Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.|||percentage of participants||95% Confidence Interval|Number
2830537|NCT00296725|Secondary|Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)|"The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1=No psychopathology 2=Minimal psychopathology 3=Mild psychopathology 4=Moderate psychopathology 5=Moderately severe psychopathology 6=Severe psychopathology 7 Extreme psychopathology. CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1=Very much improved 2=much improved 3=minimally improved 4=Unchanged 5=minimally worse 6=much worse 7=very much worse. Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define response as a CGI-I of 1 or 2; nonresponse is all other ratings (i.e., CGI-I = 3 or higher."|6 weeks.|Response Rate|||Participants|||Count of Participants
2830538|NCT00296725|Primary|Hamilton Depression Scale (HAM-D)|"The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of <=7 are accepted as indicating remission and scores that have decreased >= 50% from pre-treatment indicate positive response. Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms."|6 weeks||||score on a scale||Standard Deviation|Mean
2830540|NCT00296517|Secondary|Safety: Adverse Events by Organ System Class, Intensity, and Frequency|Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.|Baseline to Week 12|Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.|||Number of events|||Number
2830541|NCT00296517|Secondary|Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12|Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).|Week 12|Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).|||participants|||Number
2830542|NCT00296517|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Baseline to Week 8 and Week 12|Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percentage of Responders||95% Confidence Interval|Mean
2830543|NCT00296517|Secondary|Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12|The 7-point Clinical Global Impressions-Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 8, and 12|Full Analysis Set|||Points on scale||Standard Deviation|Mean
2830544|NCT00296517|Secondary|Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.|||percent change in score||Standard Deviation|Mean
2830545|NCT00296517|Secondary|Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.|||points on a scale||Standard Deviation|Mean
2830546|NCT00296517|Secondary|Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percentage of Remitters||95% Confidence Interval|Mean
2830547|NCT00296517|Secondary|Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percentage of Responders||95% Confidence Interval|Mean
2830548|NCT00296517|Secondary|Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Percent Change in score||Standard Deviation|Mean
2830549|NCT00296517|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Score in a scale||Standard Deviation|Mean
2830550|NCT00296517|Secondary|Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98|||Score in scale||Standard Deviation|Mean
2830551|NCT00296517|Primary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline and Week 12|Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160|||Score in scale||Standard Deviation|Mean
2830552|NCT00296504|Secondary|Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.|||participants|||Number
2830553|NCT00296504|Secondary|Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV or NFV in Studies APV30001 and APV30002.|||participants|||Number
2830554|NCT00296504|Secondary|Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline|The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.|||participants|||Number
2830555|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Weeks 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||log 10 copies per milliliters||Full Range|Median
2830556|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.|||log 10 copies per milliliter||Full Range|Median
2830557|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|||log 10 copies per milliliter||Full Range|Median
2830558|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 24, 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.|||cells per millimeters cubed (cells/mm^3)||Full Range|Median
2830559|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 48, 120, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|||cells per millimeters cubed (cells/mm^3)||Full Range|Median
2830560|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.|Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.|||percentage of participants|||Number
2830561|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.|Baseline and Weeks 12, 24, 48, 60, 96, and 132|All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.|||percentage of participants|||Number
2830562|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|Baseline and Weeks 48, 120, 180, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.|||percentage of participants|||Number
2830563|NCT00296504|Primary|Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||units per liter (U/L)||Inter-Quartile Range|Median
2830564|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.|||units per liter (U/L)||Inter-Quartile Range|Median
2830565|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.|||units per liter (U/L)||Inter-Quartile Range|Median
2830566|NCT00296504|Primary|Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Inter-Quartile Range|Median
2830567|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Inter-Quartile Range|Median
2830568|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216|blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Inter-Quartile Range|Median
2830569|NCT00296504|Primary|Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.|||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
2830570|NCT00296504|Primary|Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216|Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.|||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
2830571|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Final Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Post January 2006; for up to 241 weeks|All participants who remained in the study after January 31, 2006.|||participants|||Number
2830572|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Interim Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.|||participants|||Number
2830573|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of rescue-free days||Standard Error|Mean
2830574|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of rescue-free days||Standard Error|Mean
2830575|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population|Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of asthma symptom-free days||Standard Error|Mean
2830576|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Percentage of asthma symptom-free days||Standard Error|Mean
2830577|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||L/sec||Standard Error|Mean
2830578|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||L/sec||Standard Error|Mean
2830579|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)|The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.|Baseline To 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Points on a Scale||Standard Error|Mean
2830580|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).|The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)|Baseline to 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.|||Points on a Scale||Standard Error|Mean
2830581|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol.|||L/min||Standard Error|Mean
2830582|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment.|||L/min||Standard Error|Mean
2830583|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830584|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830585|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830586|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830587|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830588|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830589|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830590|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830591|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830592|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830593|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830594|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830595|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830596|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830597|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830598|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830599|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830600|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830601|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830602|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830603|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830604|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830605|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830606|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830607|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks||||Correlation coefficient|||Number
2830608|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830609|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830610|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830611|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830612|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830613|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830614|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830615|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830616|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830617|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830618|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830619|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830620|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830621|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830622|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830623|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830624|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830625|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830626|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830627|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830628|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830629|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830630|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830631|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830632|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830633|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830634|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830635|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830636|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830637|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830638|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830639|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830640|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830641|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830642|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26|"Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.~)"|Baseline and 26 weeks||||Correlation coefficient|||Number
2830643|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks||||Correlation coefficient|||Number
2830644|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|26 weeks||||Correlation coefficient|||Number
2830645|NCT00296400|Secondary|Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks||||Correlation coefficient|||Number
2830646|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks||||Correlation coefficient|||Number
2830647|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks||||Correlation coefficient|||Number
2830648|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|baseline and 26 weeks||||Correlation coefficient|||Number
2830649|NCT00296400|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]|The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.|Assessed at baseline and Week 52 [LOCF]||||mL/min||Standard Deviation|Mean
2830650|NCT00296400|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26|The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.|Assessed at baseline and Week 26||||mL/min||Standard Deviation|Mean
2830652|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 26||||ratio||95% Confidence Interval|Geometric Mean
2830653|NCT00296400|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 26||||ratio||95% Confidence Interval|Geometric Mean
2830654|NCT00296400|Primary|Urinary Protein/Creatinine Ratio at Week 52 [LOCF]|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 52 (LOCF)||||ratio||95% Confidence Interval|Geometric Mean
2830655|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830656|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830657|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830658|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830659|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830660|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830661|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830662|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830663|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830664|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830665|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830666|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830667|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830668|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830669|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks||||Correlation coefficient|||Number
2830670|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830671|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830672|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830673|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830674|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830675|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830678|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830679|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830680|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830681|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830682|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830683|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830684|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830685|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830686|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830687|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830688|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830689|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830690|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830691|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830692|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830693|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830694|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830695|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830696|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830697|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830698|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830699|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830700|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830701|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830702|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830703|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830704|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830705|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830706|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830707|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830708|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830709|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830710|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830711|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830712|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830713|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830714|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830715|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830716|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830717|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks||||Correlation coefficient|||Number
2830718|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks||||Correlation coefficient|||Number
2830719|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|Assessed at 52 Weeks||||Correlation coefficient|||Number
2830720|NCT00296374|Secondary|Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).|52 weeks||||Correlation coefficient|||Number
2830721|NCT00296374|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]||Assessed at Baseline and Week 52 [LOCF]||||mL/min||Standard Deviation|Mean
2830722|NCT00296374|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26||Assessed at Baseline and Week 26||||mL/min||Standard Deviation|Mean
2830723|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 52 LOCF||||mg/g||95% Confidence Interval|Geometric Mean
2830724|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 26||||mg/g||95% Confidence Interval|Geometric Mean
2830725|NCT00296374|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 26||||mg/g||95% Confidence Interval|Geometric Mean
2830726|NCT00296374|Primary|Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 52, Last observation carried forward (LOCF)||||mg/g||95% Confidence Interval|Geometric Mean
2830727|NCT00296335|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years|Up to 3 years||||participants|||Number
2830728|NCT00296335|Secondary|Overall Survival Rate|Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.|3 years||||percentage of participants||95% Confidence Interval|Number
2830729|NCT00296335|Primary|Relapse-free Survival Rate|"Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.~Relapse was defined as any new tumor lesion."|3 years|Intention-to treat population|||percentage of participants||95% Confidence Interval|Number
2830730|NCT00296322|Secondary|Overall Survival||3 years||||percentage of participants||95% Confidence Interval|Number
2830731|NCT00296322|Secondary|Toxicity Profile (According to NCI CTC Version 2.0)|Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.|up to 1 year||||participants|||Number
2830732|NCT00296322|Primary|Relapse-free Survival||3 years||||percentage of participants||95% Confidence Interval|Number
2830733|NCT00296296|Secondary|Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation||1 year post-transplantation||||Participants|||Count of Participants
2830734|NCT00296296|Secondary|Patient Survival at One Year Post Transplantation|Count of participants alive at one year post transplantation|Up to 1 year post-transplantation||||Participants|||Count of Participants
2830735|NCT00296296|Primary|Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation|Values of ≥60 ml/min/1.73 m^2 are considered optimal; ≥30-59 ml/min/1.73 m^2 are indicative of successful graft function; lower values are indicative or graft dysfunction.|1 year post-transplantation||||Participants|||Count of Participants
2830736|NCT00296296|Primary|Freedom From Insulin Therapy Post Transplant|The count of participants with freedom from insulin therapy post transplant is reported.|From hospital discharge to 1 year post-transplant||||Participants|||Count of Participants
2830737|NCT00296244|Secondary|New-onset Diabetes Mellitus (NODM) as Secondary Outcome|The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups.|6 months||||Percentage of participants|||Number
2830738|NCT00296244|Secondary|Incidence and Severity of HCV Recurrence Post-OLT|The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups.|6 months post-transplant|Only patients with HCV cirrhosis as the main indication for OLT were included in this analysis|||Percentage of participants|||Number
2830739|NCT00296244|Secondary|Infection as an Adverse Effect of Steroids|Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection|3 months post-transplant||||Percentage of participants|||Number
2830740|NCT00296244|Primary|Acute Rejection Rate|Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive|6 months post-transplant||||Percentage of participants|||Number
2830741|NCT00296244|Primary|Patient Survival Rate|Percentage of recipients who are still alive at the end of 1 and 2 years.|1 and 2 years||||Percentage of participants|||Number
2830742|NCT00296244|Primary|Graft Survival Rate|Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.|1 and 2 years||||percentage of participants|||Number
2830743|NCT00296231|Secondary|Transcutaneous CO2 Measurements as a Trend Throughout Intervention|We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety|2 hours||||torr||Standard Deviation|Mean
2830744|NCT00296231|Primary|pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values|Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.|2 hours||||mm Hg||Standard Deviation|Mean
2830745|NCT00296192|Secondary|"Time of First Off Reversal"|"Number of minutes to first reversal of symptoms from off to on. Estimated via Kaplan-Meier estimation method. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.|||minutes||95% Confidence Interval|Median
2830746|NCT00296192|Secondary|"Success Rate (Percentage of Subjects Achieving Off Reversals)"|"Subjects reversing from off to on following initiation of treatment. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.|||percentage of participants|||Number
2830747|NCT00296192|Secondary|Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)|One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).|Baseline and 34 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint.|||taps per minute||Standard Deviation|Mean
2830748|NCT00296192|Secondary|Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination|The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.|Baseline, and 24 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 24 minutes post-dose timepoint were not imputed; number of observations at 24 minutes post-dose timepoint may be less than that for baseline timepoint.|||score on a scale||Standard Deviation|Mean
2830749|NCT00296192|Primary|Number of Subjects Who Complete the Trial||15 days|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.|||participants|||Number
2830750|NCT00296140|Secondary|Self-efficacy|Patient-reported self-efficacy for stroke symptom management, range 1.0 - 10.0, higher scores indicate greater self-efficacy for stroke symptom management|6 months|Comparison of self-rated self efficacy for managing stroke symptoms between intervention and control subjects|||units on a scale||Standard Deviation|Mean
2830751|NCT00296140|Secondary|SS-QOL|Stroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.|6 months|Comparison of overall SS-QOL scores between intervention and control subjects|||units on a scale||Standard Deviation|Mean
2830752|NCT00296140|Primary|PHQ-9|Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms|6 months|Comparison of PHQ-9 scores between intervention and control groups|||units on a scale||Standard Deviation|Mean
2830753|NCT00296036|Secondary|Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.|A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.|First 3 weeks of treatment|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.||||||
2830754|NCT00296036|Secondary|Evaluate the Potential Toxicity of Vitamin B6.|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|up to 4, 21-day cycles|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.||||||
2830755|NCT00296036|Secondary|Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).|A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.|First 3 weeks of treatment|This endpoint is not analyzed due to the fact that Vitamin B6 had already been shown to be ineffective. Additionally, any insignificance may be due to lack of power from the smaller (Arms I, II, III and IV) than target sample size.||||||
2830756|NCT00296036|Secondary|To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream|Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 4, 21-day cycles|All patients that were evaluated for adverse events were included in this analysis.|||participants|||Number
2830777|NCT00295750|Secondary|Participants Grouped by Time to Prostate-specific Antigen Failure|The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.|12 months|ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.|||participants|||Number
2830757|NCT00296036|Primary|To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia|A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.|First 3 weeks of treatment|Eight patients from the Urea/Lactic Acid group were not included in the primary analysis (1 did not fill out the diary, 1 refused treatment, 3 had adverse events before completing the diary, and 3 for other reasons). For the placebo arm, 11 were excluded (2 refused further treatment, 2 had adverse events, and 7 went off for other reasons).|||percentage of participants|||Number
2830758|NCT00295932|Secondary|Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma|Toxicity assessed using NCI-CTC v. 3.0|2 years||||Participants|||Count of Participants
2830759|NCT00295932|Secondary|Overall Survival||2 years|Data were not collected||||||
2830760|NCT00295932|Secondary|Event-free Survival||2 years|Data were not collected||||||
2830761|NCT00295932|Secondary|Duration of Response (Mean and Median)||2 years|Data were not collected||||||
2830762|NCT00295932|Secondary|Progression-free Survival||2 years|Data were not collected||||||
2830763|NCT00295932|Primary|Maximum Tolerated Dose|Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants|2 years|This outcome is only applicable for Phase I portion of the study. The purpose of the Phase I portion of the study is to determine the Maximum Tolerated Dose and for this reason the results are not separated by dose level.|||mg/m^2 of Bortezomib|||Number
2830764|NCT00295880|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD).|Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.|1 year post transplant|Only 7 patients were at risk for chronic GVHD|||Participants|||Number
2830765|NCT00295880|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)|Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.|100 days post transplant|2 patients were not yet graded for acute gvhd|||Participants|||Number
2830766|NCT00295880|Secondary|Number of Patients Surviving at Day 100 and 1 Year.|Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.|Day 100 and 1 year||||Participants|||Number
2830767|NCT00295880|Secondary|Number of Patients With Transplant-related Mortality (TRM)|Number of patients who were deceased at days 100 and 180 from any cause other than relapse.|Day 100 and Day 180||||Participants|||Number
2830768|NCT00295880|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD)|Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.|100 days post transplant|2 patients were not graded for acute GVHD due to graft failure.|||Participants|||Number
2830769|NCT00295880|Secondary|Number of Patients With Evidence of Engraftment.|Number of patients who received both cord blood units and achieved sustained donor engraftment|1 year|1 patient was not evaluable due to graft failure|||Participants|||Number
2830770|NCT00295880|Secondary|Number of Patients Achieving Neutrophil Recovery|Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.|6 months|Patients who completed treatment.|||Participants|||Number
2830771|NCT00295880|Primary|Median Number of Days to Neutrophil Engraftment|Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.|Daily through Day 60 post transplant||||Days||Full Range|Median
2830772|NCT00295854|Primary|"Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA)"|"The primary endpoint was the GRA overall change in their condition at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved."|8 weeks||||participants|||Number
2830773|NCT00295854|Secondary|Number of Responders for GRA Assessment in Their Condition at Week 4.|Responders were defined as patients who were 'moderately improved' or 'markedly improved' and non-responders were defined as patients who were 'markedly worse', 'moderately worse', 'mildly worse', no change, or 'mildly improved' on the GRA assessments.|4 weeks||||participants|||Number
2830774|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|12 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.|||participants|||Number
2830775|NCT00295750|Secondary|The Mean Value of QTc Interval as Measured by Electrocardiogram|The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.|12 months|ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.|||milliseconds||Standard Deviation|Mean
2830776|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)|Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.|Baseline to Day 364|ITT population|||participants|||Number
2830778|NCT00295750|Secondary|Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28|Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.|Days 14 and 28|ITT population.|||percent change||Inter-Quartile Range|Median
2830779|NCT00295750|Secondary|Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252|Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.|Day 252, Day 255, and Day 259|ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.|||participants|||Number
2830780|NCT00295750|Secondary|Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3|This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.|3 days|ITT population.|||percentage of patients||95% Confidence Interval|Mean
2830781|NCT00295750|Secondary|Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment|A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).|2 weeks|ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.|||percentage of patients||95% Confidence Interval|Mean
2830782|NCT00295750|Primary|Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.|12 months|Intent-to-treat (ITT) population.|||percentage of patients||95% Confidence Interval|Mean
2830783|NCT00295633|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg*min/dL||Standard Error|Mean
2830784|NCT00295633|Secondary|Percentage of Participants Achieving A1c <7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, subjects must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||Percentage of participants|||Number
2830785|NCT00295633|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
2830786|NCT00295633|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.|||percent||Standard Error|Mean
2830787|NCT00295620|Secondary|Time to Contralateral Breast Cancer|To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of contralateral breast cancer. Subjects without contralateral breast cancer event were censored at the last date when they were known to be contralateral breast cancer free.|Risk of contralateral breast cancer was defined as the time from two years after randomization to first occurrence of new contralateral breast cancer, assessed up to a maximum of 8.5 years|All randomized patients who signed the informed consent and had no contralateral mammacarcinoma during the first two years|||Years||Inter-Quartile Range|Median
2830788|NCT00295620|Secondary|Time to Secondary Carcinoma|To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of lowering the risk of secondary carcinoma. Subjects without secondary cancer event were censored at the last date when they were known to be secondary cancer free.|Risk of secondary carcinoma was defined as the time from two years after randomization to first occurrence of new secondary cancer without new breast cancer (local or contralateral), assessed up to a maximum of 8.5 years|All randomized patients who signed the informed consent and had no secondary carcinoma (excluding contralateral mammacarcinoma) during the first two years|||Years||Inter-Quartile Range|Median
2830789|NCT00295620|Secondary|Time to First Clinical Fracture|To determine the effect of 2 years versus 5 years of additional Anastrozole after 5 years of adjuvant endocrine therapy on the time to first clinical fracture. Patients without clinical fractures where censored at their last therapy visit (approximately 5 years after randomization).|Time to first clinical fracture was defined as time to first clinical fracture, in the period from 2 years until 5 years after randomization for each patient.|All randomized patients who signed the informed consent and who had no fractures during the first two years|||Years||Inter-Quartile Range|Median
2830790|NCT00295620|Secondary|Overall Survival After Prolonged Endocrine Treatment|To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of overall survival.|Overall survival was defined as the time from two years after randomization to death due to any cause, assessed up to a maximum of 8.5 years|All randomized patients who signed the informed consent and who did not die during two first two years|||Years||Inter-Quartile Range|Median
2830791|NCT00295620|Primary|Disease-free Survival After Prolonged Endocrine Treatment|To determine whether 5 years of additional Anastrozole was more effective than 2 years of additional Anastrozole after 5 years of adjuvant endocrine therapy in terms of disease-free survival.|DFS was defined as the time from two years after randomization to the earliest occurrence of loco-regional recurrence, distant recurrence, contralateral new breast cancer, second cancer or death from any cause, assessed up to a maximum of 8.5 years|Per-Protocol (PP) Population, defined as all randomized patients who signed the informed consent who complied with the inclusion and exclusion criteria, who had at least one follow-up examination after randomization and who survived without recurrence for two years.|||Years||Inter-Quartile Range|Median
2830792|NCT00295503|Secondary|Overall Survival|overall survival was measured from time of initiation of treatment to death from any cause|from time of enrollment to death from any cause. Patients still alive at study end were censored with a minimum follow up of 6 months.||||months||95% Confidence Interval|Median
2830793|NCT00295503|Secondary|Response Rate|response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months||||percentage of participants|||Number
2830794|NCT00295503|Primary|Progression Free Survival Rate at 6 Months|This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.|patients progression free at 6 months||||percentage of participants|||Number
2830795|NCT00295490|Secondary|Adverse Event Reporting|To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.|Baseline and weeks 2,4,6,8,12 and 16|Zero participants were analysed as the study was terminated prematurely|||Participants||95% Confidence Interval|Number
2830796|NCT00295490|Secondary|Complementary and Alternative Medicine Beliefs Inventory|Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119|four monthly|Zero participants were analysed as the study was terminated prematurely|||unit on scale||95% Confidence Interval|Mean
2830797|NCT00295490|Secondary|Patient Global Assessment|To assess changes in the subject's well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely|||Unit on scale (Likert from very poor to||95% Confidence Interval|Mean
2830798|NCT00295490|Secondary|Short Form-36 (SF-36)|Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit of scale||95% Confidence Interval|Mean
2830799|NCT00295490|Secondary|Stiffness Subscale on the The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit on 100mm VAS scale||95% Confidence Interval|Mean
2830800|NCT00295490|Secondary|Disability Subscale on The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|baseline, 8 and 16 weeks|Zero participants were analysed as the study was terminated prematurely|||unit on 100mm VAS scale||95% Confidence Interval|Mean
2830801|NCT00295490|Secondary|Pain Subscale on Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit on 100mm VAS scale||95% Confidence Interval|Mean
2830802|NCT00295490|Primary|Western Ontario and Mc Master University OA Index (WOMAC)|WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.|||Unit on 100mm scale||Standard Deviation|Mean
2830803|NCT00295061|Primary|Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7|"The primary objective of this study was to demonstrate the pharmacokinetic comparability (geometric least square mean ratio of AUC between the Alpha-1 MP vs. Prolastin®, 90% confidence interval falls within 0.80-1.25, FDA Guidance as being bioequivalent between two treatments) of Alpha-1 MP to Prolastin® in subjects with alpha-1-anti-trypsin (AAT) deficiency by comparing AUC from Day 0 to Day 7 of plasma Alpha1-PI measured by the functional activity (potency) assay. AUC from Day 0 to Day 7 was calculated at steady state at the end of the first and second 8-week treatment periods during the 16-week double-blind, crossover phase."|Day 0 to Day 7||||mg*h/mL|||Number
2830804|NCT00295022|Secondary|Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season|"At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: Do you want to take the same treatment during the next pollen season? (yes or no)."|At the end of Period III (Day 2)|Only subjects with valid data were included in the analysis.|||percentage of participants|||Number
2830805|NCT00295022|Secondary|Global Satisfaction of the Subjects at the End of Period III|Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).|At the end of Period III (Day 2)|Only subjects with valid data for Global Satisfaction (VAS Score) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2830806|NCT00295022|Secondary|Variability of Action From Baseline in the MSC Score Over Period III|"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%."|Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]||||percentage of participants|||Number
2830807|NCT00295022|Secondary|Variability of Action From Baseline in the MSC Score Over Period II|"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%."|Treatment Period II [Day 2, from 9:30 am to 11:00 am]||||percentage of participants|||Number
2830808|NCT00295022|Secondary|Variability of Action From Baseline in the MSC Score Over Period I|"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%."|Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]||||percentage of participants|||Number
2830809|NCT00295022|Secondary|Intensity of Action From Baseline in the MSC Score Over Period III|The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.|Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]||||percentage of participants|||Number
2830810|NCT00295022|Secondary|Intensity of Action From Baseline in the MSC Score Over Period II|The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.|Treatment Period II [Day 2, from 9:30 am to 11:00 am]||||percentage of participants|||Number
2830811|NCT00295022|Secondary|Intensity of Action From Baseline in the MSC Score Over Period I|The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.|Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]||||percentage of participants|||Number
2830812|NCT00295022|Secondary|Onset of Action During Period I|The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.|During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]||||hours|||Number
2830813|NCT00295022|Secondary|Time to First Feeling of Improvement During Period I|During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).|During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Subjects with no first feeling of improvement were censored at 300 minutes.|||minutes||95% Confidence Interval|Median
2830814|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid individual symptom scores during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830815|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over Period III|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid individual symptom scores in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830852|NCT00294723|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
2830816|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over Period II|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid individual symptom scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830817|NCT00295022|Secondary|Change From Baseline in the Individual Symptom Scores Over Period I|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid individual symptom scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830818|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid TSC score + Nasal congestion score during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830819|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid TSC score + Nasal congestion score in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830820|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid TSC score + Nasal congestion score in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830821|NCT00295022|Secondary|Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid TSC score + Nasal congestion score in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830822|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid TSC scores during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830823|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid TSC scores in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830824|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid TSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830825|NCT00295022|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid TSC scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830826|NCT00295022|Secondary|Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid MSC scores during the Total Treatment Period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830827|NCT00295022|Secondary|Change From Baseline in the MSC Score Over Period III|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]|Only patients with valid MSC scores in Period III were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830828|NCT00295022|Secondary|Change From Baseline in the MSC Score Over Period II|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]|Only patients with valid MSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2830853|NCT00294723|Secondary|Change in Body Weight at Week 52|Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
2830829|NCT00295022|Primary|Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Efficacy variables were analyzed using the Intention-To-Treat (ITT) population. ITT consists of all randomized subjects who took at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2830830|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:~ODI score improved by at least 15% from baseline;~SF-36 score improved from baseline;~Neurologic parameters maintained or improved from baseline;~No re-operations required to modify or remove the implant; and~Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.~A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:~Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|60 Months|Patients who completed all 60 month visit analyses|||percentage of overall successes|||Number
2830831|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint.~A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:~ODI score improved by at least 15% from baseline;~SF-36 score improved from baseline;~Neurologic parameters maintained or improved from baseline;~No re-operations to modify or remove the implant; and~Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.~A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:~Same as above~Same as above~Same as above~No re-operations to modify the fusion site or correct a complication with an implant; and~Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|24 Months|Patients who completed all 24 month visit analyses|||percentage of overall successes|||Number
2830832|NCT00294762|Secondary|Duration of Tumor Response|Median length of time that tumor showed any type of response, ie, CR, PR, or SD|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).|All patients who had any type of tumor response, ie, CR, PR, or SD|||Months||Full Range|Median
2830833|NCT00294762|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment|||Percent of Patients|||Number
2830834|NCT00294762|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 29.0 months)|All patients who received at least 1 dose of study drug|||Months||Full Range|Median
2830835|NCT00294762|Secondary|Overall Survival at 12 Months|Percentage of patients alive after 12 months of study treatment|12 months from 1st dose|All patients who received at least 1 dose of study drug|||Percent of Patients||95% Confidence Interval|Number
2830836|NCT00294762|Secondary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression, as assessed every 21 days (maximum 28.8 months)|All patients who received at least 1 dose of study drug|||months||Full Range|Median
2830837|NCT00294762|Primary|6-month Progression-free Survival|Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|6 months after first dose|All patients who received at least one dose of study drug.|||Percentage of Patients||95% Confidence Interval|Number
2830838|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 104-195|Safety analysis set is all subjects who entered the year 3 extension at week 104.|||episodes|||Number
2830839|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-104|Full safety analysis set is all subjects who had been exposed to at least one dose of the study products.|||episodes|||Number
2830854|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
2830840|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830841|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830842|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830843|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
2830844|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830845|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830846|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830847|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 156|Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830848|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 104|Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830849|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 52|Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||mg/dL||Standard Error|Least Squares Mean
2830850|NCT00294723|Secondary|Change in Body Weight at Week 156|Change in body weight from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||kg||Standard Error|Least Squares Mean
2830851|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.|||percentage point of total HbA1c||Standard Error|Least Squares Mean
2830855|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin A|Vitamin A sufficiency is measured by the molar ratio of serum retinol/retinol binding protein|12 months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830856|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin E|Vitamin E sufficiency is measured as the ratio of serum vitamin E/total lipids|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830857|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin K|Vitamin K sufficiency is measured by INR (international normalized ratio)|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830858|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin D|Vitamin D sufficiency is measured by the serum level of 25-hydroxy vitamin D|12 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830859|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin A|Vitamin A sufficiency is defined as the molar ratio of serum retinol/retinol binding protein|24 months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830860|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin D|Vitamin D sufficiency is measured by the serum level of 25-hydroxy vitamin D|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830861|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin K|Vitamin K sufficiency is measured by INR (international normalized ratio)|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830862|NCT00294684|Other Pre-specified|Serum Biomarkers of Sufficiency of Fat-soluble Vitamins - Vitamin E|Vitamin E sufficiency is measured as the ratio of serum vitamin E/total lipids|24 Months|Although the protocol specified analyses of serum biomarkers as secondary outcomes, the intent was to only perform these analyses if the primary endpoint showed sufficient efficacy. Given the lack of efficacy of steroids (vs placebo), the analyses of fat-soluble vitamins were not performed; thus, data are not summarized for this assessment.||||||
2830863|NCT00294684|Secondary|Presence of Ascites at 24 Months||24 Months|Participants with their native liver at 24 months|||participants|||Number
2830864|NCT00294684|Secondary|Presence of Ascites at 12 Months||12 Months|Participants with their native liver at 12 months|||participants|||Number
2830865|NCT00294684|Secondary|Height Z-Score|Height by Age Z-score over the course of the study|HPE to age 24 Months||||Z-score||Standard Error|Mean
2830866|NCT00294684|Secondary|Weight Z-Score|weight for age Z-score (in subjects without ascites) over the course of the study|HPE until 24 months of age||||Z-score||Standard Error|Mean
2830867|NCT00294684|Secondary|Total Bilirubin Concentration at 24 Months of Age||At 24 Months of Age|Intent to treat patients with 24 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.|||mg/dL||Standard Deviation|Mean
2830868|NCT00294684|Secondary|Total Bilirubin Concentration at 12 Months||12 Months post HPE|Intent to treat patients with 12 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.|||mg/dL||Standard Deviation|Mean
2830869|NCT00294684|Secondary|Serum Total Bilirubin Concentration||Measurements will be made at 3 months after portoenterostomy|Intent to treat patients with 3 month bilirubin available are analyzed. There are no imputations for unobserved data. Patients with missing data are simply not included.|||mg/dL||Standard Deviation|Mean
2830870|NCT00294684|Secondary|Survival With Native Liver at 24 Months of Age||Measurements will be made at 24 months of age|Intent to Treat|||percentage of participants|||Number
2830871|NCT00294684|Primary|The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy||Measurements will be made at 6 months after portoenterostomy|Intent to Treat|||percentage of participants|||Number
2830872|NCT00294671|Secondary|Quality of Life Questionnaire: SF-36 Mental Component Score|The 36 item short-form health survey (SF-36) was used to assess the difference between treatment groups for change of mental component scores over 2 years treatment. Range 0-100; lower scores reflect lower quality-of-life.|Baseline, 1 and 2 years||||units on a scale||95% Confidence Interval|Mean
2830873|NCT00294671|Secondary|Quality of Life Questionnaire: SF-36 Physical Component Score|The 36 item short-form health survey (SF-36) was used to assess the difference between treatment groups for change of physical component scores over 2 years treatment. Range 0-100; lower scores reflect lower quality-of-life.|Baseline, 1 and 2 years|Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.|||units on a scale||95% Confidence Interval|Mean
2830875|NCT00294671|Secondary|Kumamoto Neurologic Scale;|Change from baseline of the Kumamoto Score (0-102 points, increasing with disease severity), a clinical neurologic scale of motor, sensory, and autonomic function combined with heart and kidney end organ measures developed to track disease progression in Familial Amyloid Polyneuropathy (ATTR-FAP)|Baseline, 1 and 2 years||||units on a scale||95% Confidence Interval|Mean
2830876|NCT00294671|Primary|Neurologic Impairment Score + 7 (NIS+7)|The primary endpoint, the difference in polyneuropathy progression between treatments, was measured by the Neuropathy Impairment Score plus 7 nerve tests (NIS+7) which ranges from 0 (no neurologic deficits) to 270 points (no detectable peripheral nerve function).|Baseline, 1 and 2 years|Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.|||units on a scale||95% Confidence Interval|Mean
2830877|NCT00294658|Secondary|Treatment Associated Symptoms (TAS)|Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Patients were in and out by visit|||Participants|||Count of Participants
2830878|NCT00294658|Secondary|Treatment Associated Complications (TAC)|Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Participants were in and out by each visit.|||Participants|||Count of Participants
2830879|NCT00294658|Secondary|Short Form-36 Standardized Mental Component|Range from 0 to 100, the higher the mental component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.|||units on a scale||Full Range|Median
2830880|NCT00294658|Secondary|Short Form-36 Standardized Physical Component|Range from 0 to 100, the higher the physical component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.|||units on a scale||Full Range|Median
2830881|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)|baseline to 3 years||||days||Standard Deviation|Mean
2830882|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)|baseline to 2 years||||days||Standard Deviation|Mean
2830883|NCT00294658|Secondary|Minimal Manifestation (MM) Status at Month 12, 24 and 36|Number of participants who were in minimal manifestation status at month 12, 24 and 36.|Month 12, 24 and 36|Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)|||participants|||Number
2830884|NCT00294658|Secondary|Intravenous Immunoglobulin Use||baseline to 3 years||||participants|||Number
2830885|NCT00294658|Secondary|Plasma Exchange Use||baseline to 3 years||||participants|||Number
2830886|NCT00294658|Secondary|Azathioprine Use||baseline to 3 years||||participants|||Number
2830887|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36|MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.|Month 12, 24, and 36|Participants were in and out at month 12, 24 and 36 visit.|||units on a scale||Standard Deviation|Mean
2830888|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL)|MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.|baseline, month 4, 6 and every 3 months through 36 months|Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.|||units on a scale||Standard Deviation|Mean
2830889|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)|For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
2830890|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)|For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
2830891|NCT00294658|Secondary|Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)|Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.|baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
2830892|NCT00294658|Secondary|Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years||||events|||Number
2830893|NCT00294658|Secondary|Cumulative Number of Hospital Days|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years||||days||Standard Deviation|Mean
2830894|NCT00294658|Secondary|Hospitalization for Exacerbation of Myasthenia Gravis||baseline to 2 years and baseline to 3 years|Number of participants who had hospitalized over 2 and 3 years|||participants|||Number
2830895|NCT00294658|Secondary|Classification of Serious Adverse Events||baseline to 3 years|One participant might had experienced more than one serious adverse event.|||participants|||Number
2830898|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.|||mg||Standard Deviation|Mean
2830899|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
2830900|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.|||mg||Standard Deviation|Mean
2830901|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.|||units on a scale||Standard Deviation|Mean
2830902|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.|||units on a scale||Standard Deviation|Mean
2830903|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.|||units on a scale||Standard Deviation|Mean
2830904|NCT00294658|Primary|Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.|||mg||Standard Deviation|Mean
2830905|NCT00294658|Primary|Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.|||units on a scale||Standard Deviation|Mean
2830906|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
2830907|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
2830908|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.|||Percentage of participants|||Number
2830909|NCT00294645|Secondary|Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
2830910|NCT00294645|Secondary|Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.|||Percentage of participants|||Number
2830911|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment||||Percentage of participants|||Number
2830912|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Analysis used subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.|||Percentage of participants|||Number
2830913|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
2830914|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
2830915|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed vs other endpoint analyses.|||Percentage of participants|||Number
2830916|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment||||Percentage of participants|||Number
2830917|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Only participants without a history of Atrial Tachycardia/Atrial Fibrillation were included in analysis of this objective.|||Percentage of participants|||Number
2830918|NCT00294645|Secondary|Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events|Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other|One year post-enrollment||||Total number actions/total number CAEs|||Number
2830919|NCT00294645|Primary|Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months|Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.|One year post-enrollment||||Percentage of participants|||Number
2830920|NCT00294632|Secondary|Objective Response Rate of Participants Treated With Lenalidomide 20 mg: Overall Response as % of Participants With Complete or Partial Response|Objective response rate defined as percentage of participants with complete or partial response after 2 cycles of therapy maintained for one month. Objective response monitored using Simon's optimal 2-stage design.|56 days|Total analyzed includes Phase 2 participants (38) which includes six participants (6) that continued from Phase 1 who were treated with 20 mg Lenalidomide.|||percentage of participants|||Number
2830921|NCT00294632|Secondary|Response of Participants Treated at Lenalidomide 20 mg|Response definitions for measurable disease from the International Workshop Standardized Response Criteria for non-Hodgkin's Lymphoma: Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of four weeks. Partial Response (PR): =/>50% decrease in sum of products of all measured lesions persisting for >four weeks. No lesion may increase in size & no new lesion may appear. Minor Response (MR): >25% but less than 50% response. Stable Disease: Steady state or response less than minor & no progression for at least 8 weeks. There may be no appearance of significant new lesions. Progressive Disease: Unequivocal increase in size of any measurable lesion or appearance of significant new.|56 days, assessed after 2 cycles|Total analyzed includes Phase 2 participants (38) which includes six participants (6) that continued from Phase 1 who were treated with 20 mg Lenalidomide.|||Participants|||Count of Participants
2830922|NCT00294632|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With Rituximab|MTD is defined as the highest dose level in which 1 or fewer participants experienced a dose limiting toxicity (DLT) in 6 participants treated. DLT is any grade III or IV toxicity during the first 28 days (first cycle) of therapy.|28 days of cycle 1||||mg|||Number
2830923|NCT00294554|Primary|CIBIC-Plus Score|"CIBIC-Plus is based upon clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. It takes into account a subject's overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. It requires the assessor to consider a number of cognitive, functional, and behavioral areas prior to providing an overall global assessment of clinical change. 7-point categorical scale that provides a single global rating of change from baseline.A score of 1 indicates marked improvement;and a score of 7, marked worsening."|24 weeks||||Participants|||Count of Participants
2830924|NCT00294554|Primary|Change in Dementia Rating Scale (DRS) Memory Subscore|The DRS is comprised of: Attention (ATT, 8 items); Initiation-Perseveration (I-P, 11 items); Construction (CONST, 6 items); Conceptualization (CONCEPT, 6 items); and Memory (MEM, 5 items). For this study, only the memory subscore was used, with score possibilities ranging from 0-5, with 5 meaning memory was perfect, 0 being no ability to recall. A negative score indicates a decrease in memory from baseline to 24 weeks.|change from baseline to 24 weeks||||units on a scale||95% Confidence Interval|Mean
2830925|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.|24 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
2830926|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.|18 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
2830927|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.|9 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
2830928|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.|6 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
2830929|NCT00294515|Primary|Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.|12 months post-transplant|Intent-to-treat population|||Percentage of patients||95% Confidence Interval|Mean
2830930|NCT00294398|Secondary|Asthma-related Quality of Life|Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.|2 months|Analysis population was based on the intention to treat number at enrollment.|||units on a scale||Standard Deviation|Mean
2830931|NCT00294398|Primary|Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)|Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.|2 months|Analysis population was based on the intention to treat number at enrollment.|||Participants|||Number
2830932|NCT00294060|Primary|Multiple In-clinic Visits|Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation|implant to one year|Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.|||participants with 2 or more visits|||Number
2830933|NCT00294060|Primary|Days Hospitalized|Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year|implant to one year|Patients with a twelve-month follow-up visit were included in the analysis.|||average days hospitalized||Standard Deviation|Mean
2830934|NCT00294060|Primary|Number of Participants With Dual Chamber Devices|Pacemaker device choice characterized by the number of patients with dual chamber devices|at original implant||||Participants with dual chamber devices|||Number
2830935|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830936|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830937|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830938|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830939|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2831001|NCT00293709|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||participants|||Number
2830940|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830941|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830942|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen||Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830943|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830944|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830945|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830946|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830947|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830948|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830949|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if~the same HPV type was found in at least one of the two (closest) preceding cytology samples, or~none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830950|NCT00294047|Secondary|Number of Subjects With Pregnancies and Their Outcomes.|Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830951|NCT00294047|Secondary|Number of Subjects Reporting Medically Significant Conditions (MAEs).|Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830952|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).||Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830953|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).|NOCDs include autoimmune disorders, asthma and type I diabetes.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830954|NCT00294047|Secondary|Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830955|NCT00294047|Secondary|Number of Subjects Reporting Related or Fatal Serious Adverse Event.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830956|NCT00294047|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.|Up to Month 48 and up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830957|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity.~A related AE = event assessed by the investigator as causally related to the study vaccination."|Within 30 days (Days 0 - 29) post-vaccination period.|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830988|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2830958|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.|||Participants|||Count of Participants
2830959|NCT00294047|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.|||Participants|||Count of Participants
2830960|NCT00294047|Secondary|Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.|"Titers are expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination.~ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%"|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Titers||95% Confidence Interval|Geometric Mean
2830961|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.|Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Participants|||Count of Participants
2830962|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).~Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2830963|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).~Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2830964|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Participants|||Count of Participants
2830989|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2831030|NCT00293293|Secondary|Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM|Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||cells/mm^3||Standard Deviation|Mean
2830965|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.|||Participants|||Count of Participants
2830966|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.~The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)"|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830967|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830968|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830969|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830970|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.~HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830971|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830972|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA status."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830973|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2830990|NCT00293722|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2830974|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830975|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~Note: Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830976|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).~Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus.~HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830977|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.~HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830978|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830979|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in:~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830991|NCT00293722|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||participants|||Number
2831031|NCT00293293|Secondary|Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from white blood cell counts collected during treatment phase of study; average applied.|Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)||||cells/mm^3||Standard Deviation|Mean
2830980|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830981|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830982|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830983|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|"CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)~Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.|||Participants|||Count of Participants
2830984|NCT00293813|Secondary|Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2830985|NCT00293813|Primary|Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months|Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2830986|NCT00293722|Other Pre-specified|Change From Baseline in Patient Global Assessment of Disease Activity at Week 52|Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||millimeter||Standard Deviation|Mean
2830987|NCT00293722|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2830992|NCT00293722|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||millimeter||Standard Deviation|Mean
2830993|NCT00293722|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2830994|NCT00293722|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2830995|NCT00293722|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||percentage of BSA||Standard Deviation|Mean
2830996|NCT00293722|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study and had safety data available.|||percentage of participants|||Number
2830997|NCT00293709|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2830998|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2830999|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2831000|NCT00293709|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2831002|NCT00293709|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||millimeter||Standard Deviation|Mean
2831003|NCT00293709|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2831004|NCT00293709|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2831005|NCT00293709|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52|PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||units on a scale||Standard Deviation|Mean
2831006|NCT00293709|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.|||percentage of BSA||Standard Deviation|Mean
2831007|NCT00293709|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study.|||percentage of participants|||Number
2831008|NCT00293579|Secondary|Overall Survival|Overall survival was measured from the time of initial study entry to death due to any cause.|Up to 2 years|All patients were deceased at the time of terminating this study.|||months||Full Range|Median
2831009|NCT00293579|Secondary|Impact of Pemetrexed Chemotherapy on Quality of Life|Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).|Baseline, End of Treatment [up to 3 years]||||Units on a scale||Standard Deviation|Mean
2831010|NCT00293579|Secondary|Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer|Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 3 years||||percent of patients|||Number
2831011|NCT00293579|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years||||patients|||Number
2831012|NCT00293540|Primary|Overall Survival|Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.|Up to 9 years|Analyzed all patients with followup data|||years||95% Confidence Interval|Median
2831013|NCT00293462|Secondary|Pain Questionnaire|Severity and quality of pain by questionnaires (0-10 with higher scores indicating more pain) at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were averages together to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.|||units on a scale||Standard Deviation|Mean
2831014|NCT00293462|Secondary|Functional Status by Karnofsky Performance Status Scale|Functional status by Karnofsky Performance Status Scale (0-100 with higher scores indicating better functional status) at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.|||units on a scale||Standard Deviation|Mean
2831015|NCT00293462|Secondary|Quality of Life During Radiation Therapy|Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Quality of Life is measured with a scale that ranges from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean.|at baseline, during radiation therapy, and once a month for 3 months after radiation therapy|Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.|||units on a scale||Standard Deviation|Mean
2831016|NCT00293462|Primary|Treatment Phase (Begins at Onset of Mucositis): Comparison of Three Groups to Evaluate the Effectiveness of the Two Mouthwashes.|To evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring. The number of days for mucositis to heal.|From onset of mucositis to healing of mucositis. Actual time variable. Mean: 95.8 days (SD 46.8)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash|||Healing Days||Standard Error|Mean
2831017|NCT00293462|Primary|Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis|Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.|Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash|||participants|||Number
2831018|NCT00293397|Primary|Efficacy - Overall Survival|Presented are the counts of patients that have survived up to 2 years.|2 Years|20 patients were assessed.|||Participants|||Count of Participants
2831019|NCT00293397|Primary|Efficacy - Overall Survival|Presented are the counts of patients that have survived up to 1 year.|1 Year|20 patients were assessed.|||Participants|||Count of Participants
2831020|NCT00293397|Primary|Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment.~Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|6 months|19 of 20 patients were assessed.|||Participants|||Count of Participants
2831021|NCT00293397|Primary|Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment.~Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|1 month|19 of 20 patients were assessed at 1 month.|||Participants|||Count of Participants
2831022|NCT00293397|Primary|Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE~Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions."|1 month|19 of 20 patients were assessed at 1 month.|||Participants|||Count of Participants
2831023|NCT00293397|Primary|Safety|Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.|6 months|19 of 20 patients were assessed at 6 months.|||Participants|||Count of Participants
2831024|NCT00293397|Primary|Safety|Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.|1 month|19 of 20 patients were assessed at 1 month.|||Participants|||Count of Participants
2831025|NCT00293384|Secondary|Toxicity Grade 3, 4, or 5||at 0-120 hours||||participants|||Number
2831026|NCT00293384|Other Pre-specified|Overall Nausea Controlled||at 0-120 hours||||participants|||Number
2831027|NCT00293384|Secondary|Delayed Vomiting Controlled||at 25-120 hours||||participants|||Number
2831028|NCT00293384|Primary|Proportion of Participants With Controlled Acute Vomiting|No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.|at 0-24 hours|Evaluable for response|||participants|||Number
2831029|NCT00293293|Secondary|Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||mg/dL||Standard Deviation|Mean
2831032|NCT00293293|Secondary|Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM|Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Participants|||Number
2831033|NCT00293293|Secondary|Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM|Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Participants|||Number
2831034|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy and CAM|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Cells per mm^3||Full Range|Mean
2831035|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy Alone|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Cells per mm^3||Full Range|Mean
2831036|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Plus CAM|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Dose (mg) per participant||Standard Deviation|Mean
2831037|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Alone|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Dose (mg) per participant||Standard Deviation|Mean
2831038|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM|Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).|||Prescriptions per participant||Standard Deviation|Mean
2831039|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone|Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients that received 6 cycles of chemotherapy alone.|||Prescriptions per participant||Standard Deviation|Mean
2831040|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Plus CAM|Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||Participants|||Number
2831041|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Alone|Number of patients who had to delay their chemotherapy treatments due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)||||participants|||Number
2831042|NCT00293293|Primary|Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM|The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy||||Scores on a scale||Full Range|Mean
2831043|NCT00293293|Primary|Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)|Measured by Functional Assessment of Cancer Therapy—Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy||||Scores on a Scale||Full Range|Mean
2831044|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831045|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831137|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.|28 days|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
2831046|NCT00293267|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
2831047|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831048|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831049|NCT00293267|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
2831050|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831051|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831052|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831053|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)|Baseline and Week 16|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-~forward for all failures/discontinued due to lack of efficacy"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831054|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants|||Number
2831055|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831056|NCT00293267|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831057|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831058|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831059|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
2831060|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
2831061|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (Cells/mm^3)||95% Confidence Interval|Mean
2831062|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)|Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831063|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831064|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
2831065|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831066|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831067|NCT00293254|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831068|NCT00293254|Secondary|Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)|Baseline and Week 16|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2831069|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants|||Number
2831070|NCT00293254|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831071|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831072|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2831073|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
2831074|NCT00293254|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
2831075|NCT00293254|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."|||Percentage of Participants||95% Confidence Interval|Number
2831076|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks||||Percentage of Participants||95% Confidence Interval|Number
2831077|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks||||Percentage of Participants||95% Confidence Interval|Number
2831078|NCT00293241|Secondary|Health State|Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.|2 years post-implant|Patients with health evaluation completed at 24 months follow-up|||units on a Health State scale||Standard Deviation|Mean
2831079|NCT00293241|Secondary|Atrial Pacing Percentage|Endpoint: Cumulative percentage atrial pacing documented in the device memory|2 years post-implant||||percentage atrial pacing||Inter-Quartile Range|Median
2831080|NCT00293241|Secondary|Patient Symptoms|Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup|Implant to 2 years post-implant||||participants|||Number
2831081|NCT00293241|Secondary|Change in PR Interval, Change in QRS Duration and Change in P-wave Duration|Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU|Implant to 2 years post-implant||||milliseconds||Standard Deviation|Mean
2831082|NCT00293241|Secondary|Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients|Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication|Implant to 2 years post-implant||||participants|||Number
2831083|NCT00293241|Secondary|Duration of Cardiovascular Related Hospitalizations|Endpoint: Duration of Cardiovascular Hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.|||Days of CV hospitalizations||Inter-Quartile Range|Median
2831084|NCT00293241|Secondary|Number of Cardiovascular Related Hospitalizations|Endpoint: Number of Cardiovascular hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.|||Number of CV Hospitalizations||Inter-Quartile Range|Median
2831085|NCT00293241|Secondary|Stroke|Endpoint: Stroke|Implant to 2 years post-implant||||participants|||Number
2831086|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant|Time to patient death from any cause|Implant to 2 years post-implant||||participants|||Number
2831087|NCT00293241|Secondary|Incidence of High Voltage Therapies|Endpoint: A high voltage therapy delivered|Implant to 2 years post-implant||||participants|||Number
2831088|NCT00293241|Secondary|Change in the Use of Cardiovascular Medication Over Time|Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant|Implant to 2 years post-implant||||participants|||Number
2831089|NCT00293241|Secondary|Change in Use of Anticoagulation|Endpoint: Use of Anticoagulation at enrollment and every follow-up visit|Implant to 2 years post-implant||||participants|||Number
2831090|NCT00293241|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.~II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.~IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases."|Baseline, one year and 2 year post-implant||||Participants|||Number
2831091|NCT00293241|Secondary|Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time|Endpoint: LVEF (%) difference between 2 year post implant and baseline|Implant to 2 years post-implant||||LVEF (%) difference||Standard Deviation|Mean
2831092|NCT00293241|Secondary|Ventricular Pacing Percentage|Endpoint: Cumulative percentage ventricular pacing documented in the device memory|Implant to 2 years post-implant||||Percentage Ventricular Pacing||Inter-Quartile Range|Median
2831093|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant|"Time to development of permanent AF fulfilling one of the following criteria:~7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or~7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient"|Implant to 2 years post-implant||||participants|||Number
2831094|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant|"Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:~7 days in a row with device diagnostic showing 20 or more hours in AT/AF or~a cardioversion was done to terminate AT/AF or~the patient is during 2 consecutive follow-up (FU) visits in AT/AF"|Implant to 2 years post-implant||||participants|||Number
2831095|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.|Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant|Implant to 2 years post-implant||||participants|||Number
2831096|NCT00293241|Primary|Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant|"Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.~Hospitalization is defined as:~admission to hospital involving one overnight stay or~emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition~Cardiovascular is defined as new or worsening:~heart failure (HF),~angina,~myocardial infarction (MI),~any arrhythmia,~stroke,~transient ischemic attack (TIA),~acute peripheral vascular emergencies,~pulmonary embolism."|Implant to 2 years post-implant|Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing > 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP|||number of participants|||Number
2831097|NCT00293059|Post-Hoc|Change in Absolute Value From Baseline MBL to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||mL||Standard Deviation|Mean
2831098|NCT00293059|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.|||Proportion of participants|||Number
2831099|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data|||g/dL||Standard Deviation|Mean
2831100|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data|||g/dL||Standard Deviation|Mean
2831101|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 196|Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data|||ng/mL||Standard Deviation|Mean
2831102|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 84|Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data|||ng/mL||Standard Deviation|Mean
2831103|NCT00293059|Secondary|Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data|||Percentage of blood volume||Standard Deviation|Mean
2831104|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831105|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196|Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831106|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831107|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831108|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831109|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831159|NCT00293033|Secondary|Episodes With Complete Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.|15 minutes|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831110|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.|treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831111|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831112|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196|Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 196|ITT, excluding participants with missing data|||days||Standard Deviation|Mean
2831113|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196|Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831114|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831115|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84|Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831116|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831117|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831118|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831119|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831120|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.|treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831121|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831122|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84|Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 84|ITT, excluding participants with missing data|||day||Standard Deviation|Mean
2831123|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84|Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831124|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented."|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831125|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented."|baseline and treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831126|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831127|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data|||scores on a scale||Standard Deviation|Mean
2831128|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831129|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831130|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 196|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831131|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 84|ITT, excluding participants with missing data|||Scores on a scale||Standard Deviation|Mean
2831132|NCT00293059|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||Sanitary protection products||Standard Deviation|Mean
2831133|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||bleeding episodes||Standard Deviation|Mean
2831134|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||bleeding days||Standard Deviation|Mean
2831135|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.|28 days|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
2831136|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.|28 days|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
2831138|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|baseline and reference period of 90 days under treatment|ITT, participants with excessive bleeding at baseline|||mL||Standard Deviation|Mean
2831139|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles|28 days|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
2831140|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles|28 days|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
2831141|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle|28 days|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
2831142|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data|||mL||Standard Deviation|Mean
2831143|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196|Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831144|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84|Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831145|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196|The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831146|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84|The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data|||Proportion of participants|||Number
2831147|NCT00293059|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with excessive bleeding.|||Proportion of participants|||Number
2831148|NCT00293059|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with frequent bleeding.|||Proportion of participants|||Number
2831149|NCT00293059|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with prolonged bleeding.|||Proportion of participants|||Number
2831150|NCT00293059|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.|during a time period of 90 days under treatment|The intent-to-treat (ITT) group consisted of all randomized participants.|||Proportion of participants|||Number
2831151|NCT00293033|Other Pre-specified|SPID in Neuropathic Pain Subpopulation|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.|60 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF])."|||Scores on a scale||Standard Error|Least Squares Mean
2831152|NCT00293033|Other Pre-specified|SPID in Neuropathic Pain Subpopulation|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.|45 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF])."|||Scores on a scale||Standard Error|Least Squares Mean
2831153|NCT00293033|Other Pre-specified|SPID in Neuropathic Pain Subpopulation|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.|30 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF])."|||Scores on a scale||Standard Error|Least Squares Mean
2831154|NCT00293033|Other Pre-specified|SPID in Neuropathic Pain Subpopulation|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.|15 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF])."|||Scores on a scale||Standard Error|Least Squares Mean
2831155|NCT00293033|Secondary|Rescue Medication Usage|Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug. Percentage of episodes when rescue medication was used per subject is analyzed.|28 Days|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831156|NCT00293033|Secondary|Episodes With Complete Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.|60 minutes|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831157|NCT00293033|Secondary|Episodes With Complete Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.|45 minutes|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831158|NCT00293033|Secondary|Episodes With Complete Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.|30 minutes|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831160|NCT00293033|Secondary|Episodes With Complete Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.|10 minutes|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831161|NCT00293033|Secondary|Episodes With Complete Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.|5 minutes|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||percentage of episodes||Standard Error|Mean
2831162|NCT00293033|Secondary|Episodes With at Least 33% Decreases in Pain|Number of episodes where the total pain score has at least a 50% reduction from baseline.|60 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831163|NCT00293033|Secondary|Episodes With at Least 33% Decreases in Pain|Number of episodes where the total pain score has at least a 33% reduction from baseline.|45 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831164|NCT00293033|Secondary|Episodes With at Least 33% Decreases in Pain|Number of episodes where the total pain score has at least a 33% reduction from baseline.|30 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831165|NCT00293033|Secondary|Episodes With at Least 33% Decreases in Pain|Number of episodes where the total pain score has at least a 33% reduction from baseline.|15 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831166|NCT00293033|Secondary|Episodes With at Least 50% Decreases in Pain|Number of episodes where the total pain score has at least a 50% reduction from baseline.|60 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831167|NCT00293033|Secondary|Episodes With at Least 50% Decreases in Pain|Number of episodes where the total pain score has at least a 50% reduction from baseline.|45 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831168|NCT00293033|Secondary|Episodes With at Least 50% Decreases in Pain|Number of episodes where the total pain score has at least a 50% reduction from baseline.|30 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831169|NCT00293033|Secondary|Episodes With at Least 50% Decreases in Pain|Number of episodes where the total pain score has at least a 50% reduction from baseline.|15 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||episodes||Standard Error|Mean
2831170|NCT00293033|Secondary|Percentage of Pain Free Episodes|A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.|60 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||percentage of episodes||Standard Error|Mean
2831171|NCT00293033|Secondary|Percentage of Pain Free Episodes|A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.|45 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||percentage of episodes||Standard Error|Mean
2831172|NCT00293033|Secondary|Percentage of Pain Free Episodes|A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.|30 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||percentage of episodes||Standard Error|Mean
2831173|NCT00293033|Secondary|Percentage of Pain Free Episodes|A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.|15 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||percentage of episodes||Standard Error|Mean
2831285|NCT00292188|Secondary|Medical Outcome Study (MOS) Optimal Sleep|Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.|Week 8|FAS, LOCF.|||participants|||Number
2831174|NCT00293033|Secondary|Percentage of Pain Free Episodes|A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.|10 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||percentage of episodes||Standard Error|Mean
2831175|NCT00293033|Secondary|Percentage of Pain Free Episodes|A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.|5 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population, however, only available data is summarized here."|||percentage of episodes||Standard Error|Mean
2831176|NCT00293033|Secondary|Subject Overall Satisfaction With Study Drug|Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent).|60 minutes or at time of rescue medication use|All efficacy analyses were conducted using the intent-to-treat (ITT) population.|||Scores on a scale|Subject Overall Satisfaction|Standard Error|Mean
2831177|NCT00293033|Secondary|Total Pain Relief|Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)|60 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831178|NCT00293033|Secondary|Total Pain Relief|Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)|45 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831179|NCT00293033|Secondary|Total Pain Relief|Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)|30 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831180|NCT00293033|Secondary|Total Pain Relief|Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)|15 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831181|NCT00293033|Secondary|Total Pain Relief|Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)|10 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831182|NCT00293033|Secondary|Total Pain Relief|Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)|5 minutes|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831183|NCT00293033|Secondary|Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.|60 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831184|NCT00293033|Secondary|Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.|45 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831185|NCT00293033|Secondary|Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.|30 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831312|NCT00291694|Secondary|Serum Estradiol Concentration|Change in serum estradiol concentration|Baseline to 12 months||||pg/ml||Standard Error|Median
2831186|NCT00293033|Secondary|Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.|15 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831187|NCT00293033|Secondary|Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.|10 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831188|NCT00293033|Secondary|Pain Relief|Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.|5 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831189|NCT00293033|Secondary|PID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.|60 minutes after dosing||||Scores on a scale|BTP Episodes|Standard Error|Mean
2831190|NCT00293033|Secondary|PID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.|45 minutes after dosing||||Scores on a scale|BTP Episodes|Standard Error|Mean
2831191|NCT00293033|Secondary|PID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.|30 minutes after dosing||||Scores on a scale|BTP Episodes|Standard Error|Mean
2831192|NCT00293033|Secondary|PID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.|15 minutes after dosing||||Scores on a scale|BTP Episodes|Standard Error|Mean
2831193|NCT00293033|Secondary|PID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.|10 minutes after dosing||||Scores on a scale|BTP Episodes|Standard Error|Mean
2831194|NCT00293033|Secondary|PID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.|5 minutes after dosing|"During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.~All efficacy analyses were conducted using the intent-to-treat (ITT) population.~Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage."|||Scores on a scale|BTP Episodes|Standard Error|Mean
2831195|NCT00293033|Secondary|SPID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.|0-60 minutes||||Scores on a scale|BTP Episodes|Standard Error|Least Squares Mean
2831196|NCT00293033|Secondary|SPID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.|0-45 minutes||||Scores on a scale|BTP Episodes|Standard Error|Least Squares Mean
2831197|NCT00293033|Secondary|SPID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.|0-15 minutes||||Scores on a scale|BTP Episodes|Standard Error|Least Squares Mean
2831268|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Total Score|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
2831198|NCT00293033|Secondary|SPID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.|0-10 minutes||||Scores on a scale|BTP Episodes|Standard Error|Least Squares Mean
2831199|NCT00293033|Secondary|SPID|Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.|0-5 minutes||||Scores on a scale|BTP Episodes|Standard Error|Least Squares Mean
2831200|NCT00293033|Primary|Summary of Pain Intensity Differences (SPID)|"Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is~-10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome."|0-30 minutes|In double-blind period, subjects received 3 doses placebo and 6 doses Onsolis. Mean SPID of Onsolis episodes and mean SPID of placebo episodes are calculated per subject and are used in analysis.Missing data were imputed on an episode-by-episode basis by carrying forward last observed data value (last observation carried forward [LOCF]).|||Score on a scale|Breakthrough Pain (BTP) Episodes|Standard Error|Least Squares Mean
2831201|NCT00293020|Primary|Percentage of Participants With Adverse Events.|After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.|Participants were followed for the duration of the study, an average of 126 days|All subjects that received at least 1 dose of study drug were included in the analysis.|||percentage of participants|||Number
2831202|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.|||hours|Participants|95% Confidence Interval|Median
2831203|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.|||hours|Participants|95% Confidence Interval|Median
2831204|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.|||hours||95% Confidence Interval|Median
2831205|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.|||hours||95% Confidence Interval|Median
2831206|NCT00292942|Secondary|Tmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (hr)|Tmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (hr)|Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion||||hr||Standard Deviation|Mean
2831207|NCT00292942|Secondary|Cmax Assessment After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)|Cmax was calculated after single 2.0, 4.0 and 8.0 mg/kg dose of Artesunate daily for 3 days (ng/mL)|Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng/mL||Standard Deviation|Mean
2831208|NCT00292942|Secondary|Range of Pharmacokinetic Parameters for Dihydroartemisinin (DHA) After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)|For DHA, AUC24, and AUClast were calculated for each dose, as well as the total area under the curve extrapolated to infinite time (AUC∞TOTAL), calculated as the sum of AUC24 for each dose +C24/λz.|Pre-dose, 5, 20, 40 minutes after infution and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng*hr/mL||Standard Deviation|Mean
2831209|NCT00292942|Secondary|Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng/mL)|For the predicted concentration at the time of dose administration (C0) was determine for each dose (ng/mL)|Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng/mL||Standard Deviation|Mean
2831210|NCT00292942|Secondary|Range of Pharmacokinetic Parameters for Artesunic Acid After Single 2.0, 4.0 and 8.0 mg/kg Dose of Artesunate Daily for 3 Days (ng*hr/mL)|For artesunic acid, AUC0-last was determine for each dose; as well as the total area under the curve (AUClastTOTAL), calculated as the sum of AUClast for each of the doses (ng*hr/mL)|Pre-dose, 5, 20, 40 minutes after infusion and 1, 2, 4, 8, 24 and 72 hours after infusion||||ng*hr/mL||Standard Deviation|Mean
2831211|NCT00292942|Secondary|Cardiovascular Responses: Number of Participants With Changes in Blood Pressure and Heart Rate After Infusion|Cardiovascular Responses: Number of participants with changes in blood pressure and heart rate after infusion to determine change from baseline|screening, on Day -1, on Days 1, 2, and 3, and at each follow-up visit||||Participants|||Count of Participants
2831212|NCT00292942|Primary|Number of Participants With AEs Occurring in Greater Frequency in the 2.0 mg/kg IV AS Group Then in the Placebo Group to Access Safety and Tolerability of AS|Comparison of number of participants with AEs reported for the placebo control and those treated with the 2.0 mg/kg of IV AS to access safety and tolerability|up to 21 days|As the intended, compassionate use dose of Intravenous Artesunate will be 2.4 mg/kg for the treatment of individuals with severe malaria, a comparison was performed between the frequency of AEs reported for the placebo control subjects and those treated with the 2.0 mg/kg dose of Intravenous Artesunate.|||Participants|||Count of Participants
2831213|NCT00292942|Primary|Number of Participants With AEs|The general strategy of the safety analysis was to examine the clinical tolerability and laboratory safety parameter data and determine if there were any trends amongst the dose levels concerning all AEs and drug related AEs.|up to 21 days||||Participants|||Count of Participants
2831214|NCT00292591|Primary|25-Hydroxyvitamin D Concentration|Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery|7 months||||ng/mL||Standard Deviation|Mean
2831215|NCT00292461|Secondary|Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.||Baseline and 16 weeks||||percentage of participants|||Number
2831216|NCT00292461|Secondary|Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period||Baseline and 16 weeks||||participants|||Number
2831217|NCT00292461|Secondary|Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period||Baseline and 16 weeks||||participants|||Number
2831218|NCT00292461|Primary|The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline|Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment|Baseline and 16 weeks|ITT (intent-to-treat)|||percent change||Full Range|Median
2831219|NCT00292370|Secondary|Change in Arizona Sexual Experience Scale (ASEX)|The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.|From Baseline (week 8) to Endpoint (week 16 or termination)|Randomized participants with an ASEX score.|||units on a scale||Standard Deviation|Mean
2831220|NCT00292370|Secondary|Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.|The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe).|Baseline (week 8) to Endpoint (week 16 or termination)|Randomized participants with an SDS score|||units on a scale||Standard Deviation|Mean
2831221|NCT00292370|Secondary|Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.|The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality.|From Baseline (week 8) to Endpoint (week 16)|Randomized participants with a PSQI score.|||units on a scale||Standard Deviation|Mean
2831222|NCT00292370|Secondary|Change in Mean Q-LES-Q Score From Baseline to Endpoint.|"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life."|From Baseline (week 8) to Endpoint (week 16 or termination)|Randomized participants with a Q-LES-Q score.|||units on a scale||Standard Deviation|Mean
2831223|NCT00292370|Secondary|Change in Total Mean Davidson Trauma Scale (DTS)|"The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D)."|From Baseline (week 8) to Endpoint (week 16 or Termination)|Randomized participants with a DTS score|||units on a scale||Standard Deviation|Mean
2831224|NCT00292370|Secondary|Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores|Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale.|From Baseline (week 8) to Endpoint (week 16 or Termination)|Randomized participants with a HAMD score.|||units on a scale||Standard Deviation|Mean
2831225|NCT00292370|Secondary|Change in Mean PANSS Total and Subscores From Baseline to Endpoint|Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms.|Baseline (week 8) to Endpoint (week 16 or termination)|Randomized participants with a PANSS score|||units on a scale||Standard Deviation|Mean
2831226|NCT00292370|Secondary|Change in CGI-I|Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse.|From Baseline (week 8) to Endpoint (week 16 or termination)|Randomized participants with CGI-I score|||units on a scale||Standard Deviation|Mean
2831269|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Frequency|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
2832538|NCT00282412|Primary|Survival|The number of participants who survived treatment|up to 5 years|The number of participants who survived treatment|||Participants|||Count of Participants
2831227|NCT00292370|Primary|Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.|The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.|From baseline (week 8) to endpoint (week 16 or termination)||||units on a scale||Standard Deviation|Mean
2831228|NCT00292318|Secondary|Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)|Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.|The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Data were not collected due medical instruments to measure this outcome were removed by VA staff causing the study to be terminated.||||||
2831229|NCT00292318|Primary|"Patient Report of Adequate Relief From FI Symptoms With a Yes Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A Responder Will be Defined as One Who Provides a Yes Answer."|Only reporting the results of participants who reported adequate relief.|The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Only participants that completed the full number of study visits were analyzed.|||participants|||Number
2831230|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831231|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831232|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831233|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831234|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831235|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831283|NCT00292188|Secondary|Clinical Global Impression of Change (CGIC)|Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF|||participants|||Number
2837090|NCT00230282|Secondary|Duration of Response||105 months||||months||Full Range|Median
2831236|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831237|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831238|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831239|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831240|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831241|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831242|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h|Safety population within the placebo patch group; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831243|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831284|NCT00292188|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF|||participants|||Number
2832628|NCT00282113|Secondary|Stool Short Chain Butyric Acid Content||4 weeks||||nmoles per mg stool||Standard Deviation|Mean
2831244|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831245|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831246|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831247|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831248|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831249|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831250|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831251|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831336|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters|Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||hours||Full Range|Median
2831252|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831253|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831254|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831255|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831256|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.|Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831257|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.|Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831258|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.|Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831259|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.|Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831438|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|1 year after treatment||||participants|||Number
2831260|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.|Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831261|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.|Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831262|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.|Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831263|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.|Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831264|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.|Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831265|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.|Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831266|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.|Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831267|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h|Safety population; only non-missing values were analyzed.|||milliseconds [ms]||Standard Deviation|Mean
2831439|NCT00290615|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.||||months||95% Confidence Interval|Median
2831440|NCT00290615|Other Pre-specified|Effect on Wound Angiogenesis||After study completion|||||||
2831270|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Severity|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.|||score on a scale||Standard Deviation|Mean
2831271|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
2831272|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
2831273|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
2831274|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.|||particpants|||Number
2831275|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
2831276|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.|||participants|||Number
2831277|NCT00292188|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score|Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.|Week 8|FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.|||percentage score on scale||Standard Error|Least Squares Mean
2831278|NCT00292188|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf)|Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.|Baseline, Week 8|Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.|||score on a scale||Standard Deviation|Mean
2831279|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Efficacy|Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
2831280|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics|Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
2831281|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on scale||Standard Deviation|Mean
2831282|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.|||score on a scale||Standard Deviation|Mean
2831441|NCT00290615|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion|||||||
2837126|NCT00229723|Secondary|Safety and Tolerability||Assessed over two years|||||||
2831286|NCT00292188|Secondary|Medical Outcome Study (MOS) Sleep Subscales|Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.|Week 8|FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.|||score on a scale||Standard Error|Least Squares Mean
2831287|NCT00292188|Secondary|Weekly Mean Sleep Interference Score|11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.|Week 8|FAS, LOCF|||score on scale||Standard Error|Least Squares Mean
2831288|NCT00292188|Secondary|Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)|Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.|Baseline, Week 8|FAS, LOCF.|||participants|||Number
2831289|NCT00292188|Secondary|Weekly Mean Pain Score From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.|Baseline through Week 8|FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively|||score on scale||Standard Error|Least Squares Mean
2831290|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.|||score on scale||Standard Error|Least Squares Mean
2831291|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.|Week 8|Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.|||score on scale||Standard Error|Least Squares Mean
2831292|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score|"Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression"|Week 8|FAS LOCF|||score on scale||Standard Error|Least Squares Mean
2831293|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|Full analysis set (FAS), last observation carried forward (LOCF)|||score on scale||Standard Error|Least Squares Mean
2831294|NCT00292188|Primary|Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.|each day of Week 8|Full Analysis Set (FAS): all randomized subjects who received >= 1 dose study drug & have post-randomization efficacy data. Last Observation Carried Forward (LOCF).|||score on a scale||Standard Error|Least Squares Mean
2831295|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at 6 Months|Plasma B-type Natriuretic Peptide (BNP)|6 months||||picograms per millilitre||Standard Deviation|Mean
2831296|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at Baseline|Plasma B-type Natriuretic Peptide (BNP) measured at basline|Baseline||||picograms per millilitre||Standard Deviation|Mean
2831297|NCT00292162|Primary|Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months|Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months|6 months||||percentage of blood ejected in one beat||Standard Deviation|Mean
2831298|NCT00292162|Primary|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %|Baseline|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study|||percentage of blood ejected in one beat||Standard Deviation|Mean
2831299|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP)|venous blood taken to assess levels of the above peptide. High evels of the peptide are associated with adverse prognosis. Blood levels are taken at baseline and 6 months. The change over 6 months is assessed, thereore it is possible to have a negative number if the level falls.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate a blood test or dropped out of the study|||picograms per millilitre||Standard Deviation|Mean
2831300|NCT00292162|Primary|Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%|left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study|||percentage of blood ejected in one beat||Standard Deviation|Mean
2840205|NCT00176891|Secondary|Donor Engraftment||Day 100 post transplant||||Participants|||Count of Participants
2831301|NCT00291876|Secondary|Number of Subjects Reporting Pregnancies After Additional Vaccination|The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.|At Months 186 and 198|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subject|||Number
2831302|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
2831303|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint.|||Subjects|||Number
2831304|NCT00291876|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
2831305|NCT00291876|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.~4 subjects received additional vaccination at Month 186 and 1 subject at Month 198."|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
2831306|NCT00291876|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||subjects|||Number
2831307|NCT00291876|Secondary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.~Please note that value 14.9 means <15."|Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||mIU/mL|||Number
2831308|NCT00291876|Primary|Number of Seropositive Subjects Against Hepatitis A Virus|A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. *The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.|||Subjects|||Number
2831309|NCT00291876|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|"Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.~* The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging."|||mIU/mL||95% Confidence Interval|Geometric Mean
2831310|NCT00291694|Secondary|Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3|Change ion ratio.|baseline to 12 months||||ratio||Standard Error|Median
2831311|NCT00291694|Secondary|Serum Sex Hormone Binding Globulin (SHBG) Concentration|Change in serum concentration|Baseline to 12 months||||nmol/L||Standard Error|Median
2831313|NCT00291694|Secondary|Mammographic Breast Density|The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.|Baseline and 12 months|Subjects completing 12 months, with baseline and 12 month mammograms suitable for density analysis, such that a change in density over time can be computed|||percentage of breast area at increased d||Standard Error|Median
2831314|NCT00291694|Primary|Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67|Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.|Baseline and 12 months||||percentage of cells staining positive||Full Range|Median
2831315|NCT00291655|Secondary|Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months||Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months|Subjects with a discontinuation visit|||kg||Standard Deviation|Mean
2831316|NCT00291655|Primary|Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase|Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).|during open-label therapy phase of 18 months|Safety population that includes all subjects that have been treated once.|||participants|||Number
2831317|NCT00291642|Secondary|Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only subjects with valid individual symptom scores in Period I and II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831318|NCT00291642|Secondary|Change From Baseline in the Individual Symptom Scores Over Period II|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]|Only subjects with valid individual symptom scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831319|NCT00291642|Secondary|Change From Baseline in the Individual Symptom Scores Over Period I|"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only subjects with valid individual symptom scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831320|NCT00291642|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid TSC scores in Period I and II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831321|NCT00291642|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]|Only patients with valid TSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831322|NCT00291642|Secondary|Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I|"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid TSC scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831335|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters|Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng/mL||Standard Deviation|Mean
2831323|NCT00291642|Secondary|Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline to Day 2|Only patients with valid MSC scores in Period I and II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831324|NCT00291642|Secondary|Change From Baseline in the MSC Score Over Period II|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]|Only patients with valid MSC scores in Period II were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831325|NCT00291642|Primary|Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I|"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline."|Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]|Only patients with valid MSC scores in Period I were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2831326|NCT00291577|Primary|Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters|Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||hours||Standard Deviation|Mean
2831327|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
2831328|NCT00291577|Primary|Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters|Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
2831329|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters|Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr.mL||Standard Deviation|Mean
2831330|NCT00291577|Secondary|Duration of Tumor Response Based on Investigator Assessment|Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Start of first confirmed CR or PR to first confirmed progression or death|ITT; subgroup of subjects with objective disease response|||weeks||95% Confidence Interval|Median
2831331|NCT00291577|Secondary|Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment|Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.|First dose of study treatment until at least 24 weeks on study|ITT; subjects with baseline assessments|||participants|||Number
2831332|NCT00291577|Secondary|Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment|Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|First dose of study treatment until at least 4 weeks after confirmed response or partial response|ITT; subjects with baseline assessments|||participants|||Number
2831333|NCT00291577|Secondary|Progression-Free Survival (PFS) Based on Investigator Assessment|Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.|First dose of study treatment until progressive disease|ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).|||weeks||95% Confidence Interval|Median
2831334|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters|Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
2831337|NCT00291577|Primary|Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.|0 hour postdose|Evaluable set of subjects for PK analysis; (n) = Number of observations above lower limit of quantification (NALQ). No participants analyzed for SU011248 C1D2 and SU012662 C1D2; standard deviation for Total drug C1D2 confirmed as 0.00 (median, minimum, and maximum = 0.20).|||ng/mL||Standard Deviation|Mean
2831338|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
2831339|NCT00291577|Primary|Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis|||ng*hr/mL||Standard Deviation|Mean
2831340|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis|||ng/mL||Standard Deviation|Mean
2831341|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).|||hours||Full Range|Median
2831342|NCT00291551|Secondary|Number of Participants Who Died|Total number of patient deaths reported prior to study closure|Study duration|per protocol|||participants|||Number
2831343|NCT00291551|Secondary|Number of Adverse Events|Total adverse events reported prior to study closure|Study duration|per protocol|||events|||Number
2831344|NCT00291551|Secondary|Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score|The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.|Baseline to 6 months|per protocol|||score on a scale||Standard Deviation|Mean
2831345|NCT00291551|Secondary|Changes in Cardiopulmonary Tests|Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months|Baseline to 6 months|per protocol|||ml/kg/min||Standard Deviation|Mean
2831346|NCT00291551|Secondary|Changes in 6 Minute Walk|Mean change in 6 minute walk distance (meters) between baseline and 6 months|Baseline to 6 months|per protocol|||meters||Standard Deviation|Mean
2831347|NCT00291551|Secondary|Change in Left Ventricular Mass|Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)|Baseline to 6 months||||grams||Standard Deviation|Mean
2831348|NCT00291551|Secondary|Change in Left Ventricular Ejection Fraction|Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol|||Percentage||Standard Deviation|Mean
2831349|NCT00291551|Secondary|Changes in Left Ventricular Volumes|Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol|||milliliters||Standard Deviation|Mean
2831350|NCT00291551|Secondary|Changes in Left Ventricular Diameters|Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol|||centimeters||Standard Deviation|Mean
2831351|NCT00291551|Secondary|Change in NYHA Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remains the same as baseline. Improved means the participant's functional class has improved (become lower in number) by at least one class. Worsened means the participatn's functional class has deteriorated (become higher in number) by at least one class."|Baseline to 6 months|per protocol|||participants|||Number
2831352|NCT00291551|Secondary|Implant Success (Number of Participants Successfully Implanted)|"Implant success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position."|1 day|per protocol|||participants|||Number
2831353|NCT00291551|Primary|Death or Additional Surgical Session at 6 Months||6 months|Per protocol|||participants|||Number
2831354|NCT00291343|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 15-24 Months of age up to Months 25-31 of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
2841163|NCT00161382|Secondary|Proportion of Students That Are Sexually Active||Measured over a period of 30 days|||||||
2831355|NCT00291343|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.|From Day 0 at months 15-24 of age to study end at Months 25-31 of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
2831356|NCT00291343|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.|During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
2831357|NCT00291343|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.|During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age|The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343.|||Subjects|||Number
2831358|NCT00291343|Secondary|Number of Subjects With Vaccine Response for rSBA-Men A, C|Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.|1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2831359|NCT00291343|Secondary|Anti-HBs Concentrations|Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to the Mencevax ACWY vaccination at 24-30 Months of age|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831360|NCT00291343|Secondary|Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs|The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).|Prior to the Mencevax ACWY vaccination at 24-30 Months of age|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2831361|NCT00291343|Secondary|Anti-PSA, Anti-PSC Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2831362|NCT00291343|Secondary|Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values|Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2831363|NCT00291343|Secondary|Anti-rSBA-MenA, C Antibody Titers|Antibody titers were expressed as Geometric Mean Titers (GMTs)|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2831364|NCT00291343|Secondary|Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values|Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128|Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.|The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2831365|NCT00291343|Primary|Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies|Antibody cut-offs were higher than or equal to (≥) 1:128|1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).|The analyses were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2831366|NCT00291330|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
2833747|NCT00268450|Secondary|Percentage of Planned Dose Received||from first treatment until end of week 12|Data for this outcome measure was not collected||||||
2831367|NCT00291330|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|"Any ACS occurring during the conduct of the study (centrally adjudicated as definite).~Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|From first intake of study drug to end of study conduct|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
2831368|NCT00291330|Secondary|Number of Participants With Bleeding Events|"Major bleeding events (MBE) were defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) was defined as~spontaneous skin hematoma >=25 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.|||participants|||Number
2831369|NCT00291330|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
2831370|NCT00291330|Secondary|Number of Participants Who Died Due to VTE|"VTE - related deaths which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
2831371|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|"Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
2831372|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic DVT|"Symptomatic DVT which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||participants|||Number
2831373|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|"VTE or any death which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||Participants|||Number
2831374|NCT00291330|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.|||Participants|||Number
2831517|NCT00290147|Secondary|Anti-dengue Antibody and T-cell and B-cell Responders|Number of participants who responded, are reported. Response or a positive ELISPOT assay was defined as >65 spot forming cells per million PBMC for T-cells and >20 spot forming cells per million PBMC for B-cells|12 months||||Participants|||Count of Participants
2841164|NCT00161382|Secondary|Communication With Parents||Measured throughout the study|||||||
2831375|NCT00291317|Primary|Change in Bone Mineral Density Measured Via DEXA Scan|Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention.|At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)||||g/cm^2||Standard Deviation|Mean
2831376|NCT00291317|Primary|Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.|The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement.|pre- and post-intervention; time frame among participants ranged from 4 to 12 months|Four of the six participants completed the PedsQL on at least 2 occasions. At minimum, each completed the PedsQL at their initial evaluation before beginning the cycling program and at or following their last cycling session.|||units on a scale||Standard Deviation|Mean
2831377|NCT00291226|Primary|Change in Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Change from Baseline at 8 Weeks||||units on a scale||Standard Deviation|Mean
2831378|NCT00291226|Primary|Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2831379|NCT00291187|Post-Hoc|Average Improvement in Latency to Non-awake (LNA)|The average improvement in latency to non-awake (length of time elapsed between lights off and first epoch of sleep determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||Minutes||Standard Error|Mean
2831380|NCT00291187|Post-Hoc|Average Improvement in Total Sleep Time (TST)|The average improvement in Total sleep time (determined by PSG and defined as the number of non-wake minutes between lights off and lights on) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||Minutes||Standard Error|Mean
2831381|NCT00291187|Secondary|Average Improvement of Wake After Sleep Onset (WASO)|The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||minutes||Standard Error|Mean
2831382|NCT00291187|Primary|Average Improvement of Latency to Persistent Sleep (LPS)|The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.|||minutes||Standard Error|Mean
2831383|NCT00291161|Primary|Veteran Outcomes|The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).|Baseline - six months|Data were collected for veterans who could be interviewed only.|||units on a scale||Standard Deviation|Mean
2831434|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|"The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: 0 representing an excellent result; 1 a good result; 2 a fair result; and 3 a poor result."|6 months after treatment||||percentage of physicians|||Number
2831384|NCT00291161|Primary|Caregiver Outcomes|The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)|Baseline and at six months|Data were collected for caregivers only|||units on a scale||Standard Deviation|Mean
2831385|NCT00291135|Primary|Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.|Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.|Baseline, 6 months|All subjects completed study and were used for analysis|||Change in % of cells positive for Ki-67||Full Range|Median
2831386|NCT00291018|Secondary|Surgery Again|% of subjects who would opt to have the surgery again if given the choice at 84 months|84 Months|Subjects who completed this questionnaire at 84 months|||% of Subjects|||Number
2831387|NCT00291018|Secondary|VAS Arm Pain Frequency|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of None of the Time [Arm] Pain at 0mm and All of the Time [Arm] Pain at 100mm."|84 Months|Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months|||% of Subjects|||Number
2831388|NCT00291018|Secondary|VAS Arm Pain Intensity|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No [Arm] Pain at 0mm and Worst [Arm] Pain Possible at 100mm."|84 Months|Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months|||% of Subjects|||Number
2831389|NCT00291018|Secondary|VAS Neck Pain Frequency|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of None of the Time [Neck] Pain at 0mm and All of the Time [Neck] Pain at 100mm."|84 Months|Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months|||% of Subjects|||Number
2831390|NCT00291018|Secondary|VAS Neck Pain Intensity|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No [Neck] Pain at 0mm and Worst [Neck] Pain Possible at 100mm."|84 Months|Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months|||% of Subjects|||Number
2831391|NCT00291018|Secondary|VAS Satisfaction|"The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of No Satisfaction [with the surgery/outcome] at 0mm and Complete Satisfaction [with the surgery/outcome] at 100mm."|84 Months|Subjects who completed the VAS Satisfaction Questionnaire at 84 Months|||||Standard Deviation|Mean
2831392|NCT00291018|Secondary|SF-36 Mental Composite Score (MCS)|"The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.~It can take patients at least half an hour to complete the SF-36.~The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions."|84 Months|Subjects who completed the SF-36 questionnaire at 84 Months|||% of Subjects|||Number
2831393|NCT00291018|Secondary|SF-36 Physical Composite Score (PCS)|"The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.~It can take patients at least half an hour to complete the SF-36.~The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions."|84 Months|Subjects who completed the SF-36 questionnaire at 84 Months|||% of Subjects|||Number
2831394|NCT00291018|Secondary|NDI|"NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain.~The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation.~Mean duration of the test is 3-8 minutes and the results can be interpreted as:~0-4 points (0-8%) no disability;~5-14 points (10-28%) mild disability;~15-24 points (30-48%) moderate disability;~25-34 points (50-64%) severe disability;~35-50 points (70-100%) complete disability"|84 months|Completed the NDI Questionnaire at 84 Months|||% of Subjects|||Number
2831395|NCT00291018|Secondary|Neurologic Success|% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)|84 months|"Subjects who were per protocol excluding device failures"|||% of Subjects|||Number
2831435|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|more than 6 months after treatment, for up to 5 years||||percentage of participants|||Number
2831396|NCT00291018|Primary|Overall Success|Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material|84 Months|Subjects with data at 84 months|||% of Subjects|||Number
2831397|NCT00290888|Secondary|Upper Extremity Strength Grading||24 months|||||||
2831398|NCT00290888|Secondary|Shoulder Range of Motion||24 months|||||||
2831399|NCT00290888|Primary|American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)|Calculated as a percentage with an increase in score reflecting an improvement in outcome.|24 months||||percentage of total score||Standard Deviation|Mean
2831400|NCT00290888|Primary|Western Ontario Rotator Cuff Index (WORC)|Calculated as percentage with an increase in score indicating an improvement in outcome.|24 months||||percentage of total score||Standard Deviation|Mean
2831401|NCT00290810|Secondary|Time to Progression|"Progression is defined as one of the following:~A ≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥2 cm) or the appearance of new palpable lymph nodes, or~A ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or the appearance of hepatomegaly or splenomegaly which was not previously present, or~The transformation to a more aggressive histology (e.g. Richter's transformation), or~A ≥ 50% increase in the absolute number of circulating lymphocytes.~The Kaplan-Meier method will be used to estimate time to progression."|From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years||||months||95% Confidence Interval|Median
2831402|NCT00290810|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate distributions in the B-CLL population.|From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years.||||months||95% Confidence Interval|Median
2831403|NCT00290810|Secondary|Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).|As per NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The number of participants experiencing grade 3 or higher toxicity will be reported here.|From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days.|All 12 participants treated will be used to analyze this endpoint.|||participants|||Number
2831404|NCT00290810|Primary|Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).|"The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart.~Complete Response:~No lymphadenopathy~No hepatomegaly or splenomegaly~Absense of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets > 100,000/ul~Hemoglobin > 11.0 gm/dl~Peripheral blood lymphocytes ≤ 4000/uL.~Confirmation by Marrow Aspirate and biopsy.~Complete Clinical Response:~-CR without bone marrow biopsy confirmation.~Nodular Partial Response:~-CR with the presence of residual clonal nodules.~Partial Response requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul~Hemoglobin >11.0 gm/dl"|Up to 5 years|All 12 patients are used in this analysis|||participants|||Number
2831405|NCT00290771|Secondary|Number of Patients With at Least 1 Adverse Event|An adverse event (AE) is any undesirable sign, symptom, or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. Study drug refers to imatinib or hydroxyurea. The study treatment is the combination of these two study drugs.|Baseline to end of study (Month 24)|Safety population: All patients who received at least 1 dose of either of the 2 study drugs and who had at least 1 post-baseline safety assessment.|||Participants|||Number
2831406|NCT00290771|Secondary|Percentage of Patients Surviving at Months 6, 12, and 24|Patients not known to have died were censored at the time of last survival follow-up.|Months 6, 12, and 24|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
2831407|NCT00290771|Secondary|Percentage of Patients With Progression-free Survival at Months 6 and 12|Progression-free survival (PFS) was defined as the time from the start of treatment to the date of the first documented disease progression (PD) or death due to any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, progression-free survival was censored at the time of the last overall response assessment.|Months 6 and 12|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
2831408|NCT00290771|Secondary|Percentage of Patients Who Had Clinical Benefit|Patients who had clinical benefit were patients with a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting for more than 6 months from the start of treatment until the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. SD was defined as insufficient tumor shrinkage to qualify for PR or CR and no increase in lesions which would qualify as PD.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
2831436|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|within 6 months of treatment||||percentage of participants|||Number
2833748|NCT00268450|Secondary|Median Overall Surivial||from first treatment until death|Data for this outcome measure was not collected||||||
2831409|NCT00290771|Secondary|Duration of Objective Overall Response (OOR)|Duration of OOR only included patients whose best overall response was complete response (CR) or partial response (PR). The start date was the date of the first documented response (CR or PR); the end date was the date of the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, the duration of OOR was censored at the time of the last OOR assessment.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Weeks||95% Confidence Interval|Median
2831410|NCT00290771|Primary|Percentage of Patients With an Objective Overall Response (OOR)|Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR).|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.|||Percentage of participants||95% Confidence Interval|Number
2831411|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2|Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 month - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in ps2 concentration available for 44 participants. Analysis performed by menopause and cancer status.|||ng/ml||Standard Deviation|Mean
2831412|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D|Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in Cathespin D concentration available for 44 participants. Analysis performed by menopause and cancer status.|||mg/ml||Standard Deviation|Mean
2831413|NCT00290758|Secondary|Plasma Concentration of Sex Hormone Binding Globulin (SHBG)||6 months - baseline|Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status.|||nmol/L||Standard Deviation|Mean
2831414|NCT00290758|Secondary|Monitor Drug Delivery by Measuring Plasma Genistein by HPLC|Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.|6 months - baseline|Analysis performed by menopause and cancer status.|||ng/ml||Standard Deviation|Median
2831415|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol|Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in estradiol concentration available for 40 participants. Analysis performed by menopause and cancer status.|||pg/ml||Standard Deviation|Mean
2831416|NCT00290758|Secondary|Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.|"Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as atypical. Mean change in the percent pixels assigned atypical is assessed from baseline to 6 month follow up."|6 months - baseline|Analysis performed by menopause and cancer status.|||Percent pixels||Standard Deviation|Mean
2831417|NCT00290758|Secondary|Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)|Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in EGF concentration available for 43 participants. Analysis performed by menopause and cancer status.|||ng/ml||Standard Deviation|Mean
2831418|NCT00290758|Primary|Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling|Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.|6 months - baseline|Participants who had more than 4,000 epithelial cells in rFNA samples at both baseline and 6 month follow up, met the criteria for compliance, and were available for evaluation of Ki-67 labeling index at both time points. Analysis performed by menopause and cancer status.|||Ki-67 labeling index||Standard Deviation|Mean
2831419|NCT00290732|Secondary|Concentrations of Doxorubicin in Tissue at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.|Day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.|||nmol/g|||Number
2831420|NCT00290732|Secondary|Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.|Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.|||nM|||Number
2831421|NCT00290732|Primary|Maximum Tolerated Dose (MTD)|Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.|Until up to 30 days after PLD administration|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.|||milligrams|||Number
2831437|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|5 years after treatment||||participants|||Number
2831422|NCT00290706|Secondary|Evaluate Safety and Tolerability of Bortezomib and Gemcitabine Therapy|"Safety and tolerability of the study drugs will be assessed on Day 1 and on either Day 8 or Day 15 of each treatment cycle (1 Cycle - 28 days) while on active treatment; and 30 days post last treatment. Adverse Events that are experienced by patients, determined to be either grade 3 or grade 4 and at least possibly related to at least one of the study drugs as assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) will be collected. In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|During treatment through a maximum of 8 Cycles (1 Cycle = 28 Days) and 30 days post last treatment|The study was terminated before total accrual was met due to lack of efficacy. Data was not collected for analysis for this outcome measure||||||
2831423|NCT00290706|Secondary|Overall Survival|Overall survival will be evaluated every 6 months while on treatment and then every 6 months while off of treatment for up to 3 years|Every 6 months while on treatment and then every 6 months while off of treatment for up to 3 years|The study was terminated early due to lack of efficacy. Data not collect for analysis of this outcome measure.||||||
2831424|NCT00290706|Secondary|Time to Treatment Failure and Duration of Response|Time to treatment failure and duration of response will be measured by CT Scan at screening and after completing cycle 3, cycle 6 and 30 days after cycle 8, then every 6 months for 3 years|At screening and after completing cycle 3, cycle 6 and 30 days after cycle 8, then every 6 months for 3 years|Study was terminated due to lack of efficacy. Data not collected for analysis of outcome measure.||||||
2831425|NCT00290706|Primary|Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.|"Response rate in patients with relapsed or refractory B- and T-cell NHL with Gemcitabine and Bortezomib combination treatment will be defined as the number of patients with Complete Remission [CR] and Partial Remission [PR]. CT scans at screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8 assessed by the Response Criteria for Non-hodgkins Lymphoma will be used to determine response where:~CR=Complete disappearance of all detectable clinical and radiographic evidence of disease PR=> 50% decrease in SPD of the six largest dominant nodes or nodal masses"|At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8|Patients must complete 3 cycles of treatment to be evaluable for this outcome measure. Only 3 patients reached Cycle 3 and the study closed before accrual was met due to lack of efficacy. Below shows response of patients that reached Cycle 3 and is not a reflection of response rate.|||participants|||Number
2831426|NCT00290693|Secondary|Number of Study Participants Experiencing Toxicity After Receiving Protocol Therapy|Number of study participants experiencing toxicity (serious adverse events or adverse events). Study participants assessed for this outcome measure must have received at least one dose of protocol therapy. Toxicity assessed according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).|Up to 1 year|Study participants who received at least one dose of protocol therapy.|||participants|||Number
2831427|NCT00290693|Secondary|Rate of Participants Achieving a 50% or More Reduction in CA 19-9 Levels|Rate of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the > 50% drop can be confirmed with at least one more CA 19-9 level thereafter with > 50% drop compared to baseline.|Up to 1 year|Participants who had available baseline CA19-9 levels above 100 U/ml.|||percentage of participants|||Number
2831428|NCT00290693|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is measured the time from the start of protocol therapy to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 1 year|Number of participants who completed at least one cycle of protocol therapy.|||months||95% Confidence Interval|Median
2831429|NCT00290693|Secondary|Overall Surival (OS)|Overall survival is measured from the time from date of initial protocol therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up.|Up to 1 year|Number of participants who completed at least one cycle of protocol therapy.|||months||95% Confidence Interval|Median
2831430|NCT00290693|Primary|Rate of Participants Achieving Complete Response or Partial Response to Therapy.|Rate of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 1 year|Number of participants evaluable for response, that is, who completed at least one cycle of protocol therapy.|||participants|||Number
2831431|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|"The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: 0 representing an excellent result; 1 a good result; 2 a fair result; and 3 a poor result."|12 months after treatment||||percentage of participants|||Number
2831432|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|"The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: 0 representing an excellent result; 1 a good result; 2 a fair result; and 3 a poor result."|6 months after treatment||||percentage of participants|||Number
2831433|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|"The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: 0 representing an excellent result; 1 a good result; 2 a fair result; and 3 a poor result."|12 months after treatment||||percentage of physicians|||Number
2831442|NCT00290615|Secondary|Progression-free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~This is the average number of months participants survived without showing progressive disease."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.||||months||95% Confidence Interval|Median
2831443|NCT00290615|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.||||participants with adverse event|||Number
2831444|NCT00290615|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who received restaging scans were analyzed.|||percentage of participants with response||95% Confidence Interval|Number
2831445|NCT00290589|Secondary|Number of Patients Using Analgesics|Use of analgesics for low back pain (within the previous 24 hours)|Assessed at 1 month||||Participants|||Count of Participants
2831446|NCT00290589|Primary|Functional Disability Scales|The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.|1 month||||units on a scale||Inter-Quartile Range|Median
2831447|NCT00290589|Primary|Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable|Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable.|1 month||||units on a scale||Standard Deviation|Mean
2831448|NCT00290537|Primary|Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)|Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.|Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).||||Participants|||Number
2831449|NCT00290472|Primary|Overall Survival|The overall survival was evaluated using the Kaplan-Meier estimator.|Up to 6 years||||Month||95% Confidence Interval|Median
2831450|NCT00290472|Primary|Duration of Response|Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|Up to 6 years||||Month||95% Confidence Interval|Median
2831451|NCT00290472|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|Up to 6 years||||percentage of participants|||Number
2831452|NCT00290407|Secondary|Blood Specimens Will be Collected to Measure Immunologic Effect||at weeks 4, 8, 12, and at month 6|||||||
2831453|NCT00290407|Primary|CT Scan to Measure Clinical Effect (Response)|Study terminated, results data not available|3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression|||||||
2831454|NCT00290355|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters|The parameters analysed were Albumin (ALB), Bicarbonate (BIC), Blood urea nitrogen (BUN), Calcium (CAL), Chloride (CHL), Cholesterol (CHO), Creatinine (CREA), Glucose (GLU), Magnesium (MAG), Phosphate (PHO), Potassium (POT), Sodium (SOD), Total protein (TPROT), Total bilirubin (TBIL), Triglycerides (TRIG) and Uric acid (UAC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.|At Month 6, Month 12, Month 18, Month 24 and Month 30|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with data available for the respective assay.|||Participants|||Count of Participants
2831455|NCT00290355|Secondary|Number of Subjects With Normal and Abnormal Hematological Parameters|The parameters analysed were Basophils (BAS), Eosinophils (EOS), Haemoglobin (HGB), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC), Sedimentations rate (SED) and White Blood Cells (WBC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.|At Month 6, Month 12, Month 18, Month 24 and Month 30|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with data available for the respective assay.|||Participants|||Count of Participants
2831518|NCT00290147|Primary|Systemic and Local Reactogenicity Rates for Ungraded Symptoms|Summary of ungraded systemic and local reactogenicity symptoms following each vaccination|Months 0, 1 and 5||||Participants|||Count of Participants
2833749|NCT00268450|Secondary|Progression Free Survival||from first treatment until time of progression or death, whichever comes first|Data for this outcome measure was not collected||||||
2831456|NCT00290355|Secondary|Number of Subjects With Normal and Abnormal Urinalysis Parameters|The parameters analysed were Protein, Red Blood Cells (RBC) and White Blood Cells (WBC), with respect to normal laboratory ranges. The subjects were grouped by status at baseline.|At Month 6, Month 12, Month 18, Month 24 and Month 30|The analyses were performed on the Total Treated cohort gene signature (GS) set, which included all subjects of the Total Treated cohort for whom ribonucleic acid (RNA) from their tumour samples was available to perform the gene signature test and with data available for the considered assay.|||Participants|||Count of Participants
2831457|NCT00290355|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study (Day 0 - Month 86)|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.|||Participants|||Count of Participants
2831458|NCT00290355|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-vaccination period|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.|||Participants|||Count of Participants
2831459|NCT00290355|Secondary|Number of Subjects With Any, Grade 2/3/4 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, myalgia, nasea, rigors/chills, sweating/diaphoresis, temperature [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 4 Fatigue = Bedridden or disabling. Grade 4 Headache, Myalgia = Disabling. Grade 3 Nausea = No significant intake, requiring i.v. fluids. Grade 3 Rigors/Chills = Not responsive to narcotic medication. Grade 2 Sweating/Diaphoresis = Frequent or drenching. Grade 4 Vomiting = Requiring parenteral nutrition; or physiologic consequences requiring intensive care; haemodynamic collapse. Grade 3 fever = fever higher than (>) 40.0 °C for more than 24 hours. Related = symptom assessed by the investigator as related to the vaccination.|During the 8-day (Days 0-7) post-vaccination period, across doses|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with a documented symptom sheet.|||Participants|||Count of Participants
2831460|NCT00290355|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 8-day (Days 0-7) post-vaccination period, across doses|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration and with a documented symptom sheet.|||Participants|||Count of Participants
2831461|NCT00290355|Secondary|Number of Patients Reporting Non-small-cell Lung Cancer (NSCLC) Recurrence by Gene Signature|Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. Gene expression profiling was performed by qRT-PCR in primary tumor samples taken at the time of resection of the tumor, and thus before any study treatment. Gene signature positive (GS+) and negative (GS-) profiles were assessed with a 61-set gene signature (GS) and a classifier which were defined in the Phase II melanoma EORTC 16032-18031 study.|Over a median follow up time of 86 months|Analysis was performed on the Total Treated cohort Gene Signature set which included all subjects of the Total Treated cohort for whom ribonucleic acid (RNA) from their tumour samples was available to perform the gene signature test.|||Participants|||Count of Participants
2831462|NCT00290355|Secondary|Number of Subjects With Cell-mediated Immunity (CMI) CD4+ or CD8+ Response|Responders are patients with at least 5x10⁻⁶ increase in minimal CD4 or CD8 precursor frequency versus baseline. Any = at least one post treatment time point.|At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Month 60|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.|||Participants|||Count of Participants
2831463|NCT00290355|Secondary|Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 8+ Response|Responders were patients with at least 5x10⁻⁶ increase in minimal CD8 precursor frequency versus baseline. Any = at least one post treatment time point.|At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.|||Participants|||Count of Participants
2831464|NCT00290355|Secondary|Number of Subjects With Cell-mediated Immunity (CMI) Cluster of Differentiation (CD) 4+ Response|Responders were patients with at least 5x10⁻⁶ increase in minimal CD4 precursor frequency versus baseline. Any = at least one post treatment time point.|At Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.|||Participants|||Count of Participants
2831465|NCT00290355|Secondary|Anti-protein D (Anti-PD) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses|||EL.U/mL||95% Confidence Interval|Geometric Mean
2831466|NCT00290355|Secondary|Number of Subjects Seropositive Against Protein D (PD) Antigens|A seropositive subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 100.000 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.|||Participants|||Count of Participants
2831467|NCT00290355|Secondary|Anti- MAGE-A3 Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses|||EL.U/mL||95% Confidence Interval|Geometric Mean
2831468|NCT00290355|Secondary|Number of Subjects Seropositive Against MAGE-A3|A seropositive subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 27.000 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Day 0, Week 6, Week 12, Month 9, Month 18, Month 24, at Month 30 and at Follow-Up (FU) visit (Post Dose 13 at Month 42 for patients with full treatment course or Post last product dose + 12 months for the other patients)|The analyses were performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable patients for whom immunogenicity post product administration data were available for the considered assay. For each patient, data collected after major protocol violation were eliminated from ATP immunogenicity analyses.|||Participants|||Count of Participants
2831469|NCT00290355|Secondary|Number of Participants Who Died - Overall Survival (OS)|Overall Survival (OS) was based on total number of deaths, irrespective of cause of death. Non-small-cell Lung Cancer Overall Survival (NSCLC-OS) was based on total number of deaths due to lung cancer; deaths due to other or to unknown causes were censored appropriately.|Over a median follow-up time of 44 months post-Dose 1|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.|||Participants|||Count of Participants
2831470|NCT00290355|Secondary|Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence or Death - Disease Free Survival (DFS)|Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.|Over a median follow-up time of 44 months post-Dose 1|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration.|||Participants|||Count of Participants
2831471|NCT00290355|Secondary|Percentage of Patients With Disease Recurrence|Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.|At 6, 12, 18, 24 and 30 months after enrolment|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration. This analysis was based on the confirmed NSCLC recurrence so that patients withdrawn before imaging were removed.|||Percentage of Patients|||Number
2831472|NCT00290355|Primary|Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence|Types of recurrence included local, regional and distant metastasis and second primary lung tumours, and comprised: Local recurrence, defined as a tumour within the same lung or at the bronchial stump; Regional recurrence, involving a clinically or radiologically manifest disease in the mediastinum or in supraclavicular nodes; and Distant recurrence, i.e., any tumour arising in the contralateral lung or outside the hemithorax. The time to recurrence was defined as the interval from the date of surgical resection to the date of recurrence. The latter was defined as the date of the first study assessment at which new lesion(s) were found and confirmed by appropriate imaging.|Over a median follow-up time of 28 months post-Dose 1|The analyses were performed on the Total Treated cohort, which included all patients who were randomised and who received at least one dose of the randomised study product administration. This analysis was based on the confirmed NSCLC recurrence so that patients withdrawn before imaging were removed.|||Participants|||Count of Participants
2833750|NCT00268450|Secondary|Urinary Cytogenitics||baseline and week 12|Data for this outcome measure was not collected||||||
2831473|NCT00290342|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 5)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2831474|NCT00290342|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
2831475|NCT00290342|Secondary|Number of Subjects Reporting Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.|||Subjects|||Number
2831476|NCT00290342|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.|||Subjects|||Number
2831477|NCT00290342|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2831478|NCT00290342|Secondary|Titers for Poliovirus Type 1, 2 and 3 Antibodies|Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2831479|NCT00290342|Secondary|Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2831480|NCT00290342|Secondary|Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)|A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).|Before (Pre) and one month after (Post) the primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2831481|NCT00290342|Primary|Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens|Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2831482|NCT00290342|Primary|Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)|Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2831520|NCT00289991|Secondary|Duration of Treatment|Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations.|||days||Full Range|Median
2832539|NCT00282347|Secondary|Change From Baseline in C3 and C4 Complement Levels at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||mg/dL||Standard Deviation|Mean
2831483|NCT00290342|Primary|Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2831484|NCT00290342|Primary|Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)|A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).|One month (Month 5) post-primary vaccination course|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2831485|NCT00290329|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831486|NCT00290329|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831487|NCT00290329|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom reported irrespective of intensity grade and causal relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831488|NCT00290329|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831489|NCT00290329|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site (Mencevax ACWY 2-5 YOA Group) and beyond 50 millimeters (mm) of injection site (Mencevax ACWY 6-17 YOA Group and Mencevax ACWY ≥ 18 YOA Group).|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831490|NCT00290329|Primary|Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831491|NCT00290290|Primary|The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.|The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.|during surgery and within the 30 days post surgery||||Percentage of Post Operative Infections|||Number
2831521|NCT00289991|Secondary|Survival: Percent of Subjects Who Died Within 1 Year|Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.|Day 1 up to 1 year (Day 365)|MITT; data from 1 site excluded due to GCP deviations. Typically, subjects received first dose study treatment on the day of their transplant; however, some subjects started treatment up to 48 hours after transplant. Data summarized with first day of study medication defined as Day 1.|||percent of participants|||Number
2831492|NCT00290251|Secondary|Quality of Life|The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.|3 months (Baseline to end of treatment 1)|All completers received a questionnaire at the end of the three-month study. One woman in the placebo group did not complete the questionnaire.|||units on a scale||Standard Error|Mean
2831493|NCT00290251|Primary|Shrinkage of Fibroids - Size of Fibroids|The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.|3 months (baseline to end of treatment)|Per protocol, including women with two MRIs regardless of whether they took all study medication|||logcm3||Standard Error|Mean
2831494|NCT00290238|Secondary|Total Expenditure Per Day on All Lower Back Pain Related Interventions|Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers' Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.|Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12|Analysis population was intention to treat (ITT).|||Dollars||Full Range|Median
2831495|NCT00290238|Primary|Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score|"Visual analog scale (VAS) for pain (100mm line with 0/No pain on the left and 100/Worst pain imaginable on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits."|Time-averaged from the first available observation to the last available observation (12 months for completed subjects)|Analysis population was intention to treat (ITT), excluding subjects who had no follow-up (after the initial 10-week treatment phase) data available.|||mm||Standard Error|Least Squares Mean
2831496|NCT00290199|Secondary|Induction to Vaginal Delivery Interval|Mean hours from time of induction to vaginal delivery interval.|time from induction to vaginal delivery, up to 24 hours||||hours||Standard Deviation|Mean
2831497|NCT00290199|Secondary|Cesarean Rate|The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.|at delivery||||percentage of subjects|||Number
2831498|NCT00290199|Secondary|Rate of Delivery (Vaginal or Cesarean)by 24 Hours|The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.|from start of induction to 24 hours post start of induction||||percentage of deliveries|||Number
2831499|NCT00290199|Primary|Hours From Placement of Foley or Initiation of Oxytocin to Delivery|The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)|Time from induction to delivery||||hours||Standard Deviation|Mean
2831500|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time Variability in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the variability in processing time in milliseconds that it takes to correctly respond to a target. Response time variability = the standard deviation of response times for correct responses. Lower values represent less variability and better responses. Range of response times = 0-2000 milliseconds.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||time in milliseconds||95% Confidence Interval|Mean
2831501|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the processing time in milliseconds that it takes to correctly respond to a target. Lower times represent better response times. Range = 0 - 2000 milliseconds|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||time in milliseconds||95% Confidence Interval|Mean
2831502|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Nonresponses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly not selected (number of times a child correctly refrains from hitting a buzzer) when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct nonresponses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||Number of correct nonresponses||95% Confidence Interval|Mean
2831522|NCT00289991|Secondary|Time to Discontinuation of Study Treatment|Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations.|||days||95% Confidence Interval|Mean
2831503|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Responses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly selected when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct responses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||number of correct responses||95% Confidence Interval|Mean
2831504|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Social Function|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 5 items of daily activity grouped under social function. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-25 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831505|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Mobility|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 7 items of daily activity grouped under mobilityare. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-35 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831506|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Self-care|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 8 items of daily activity grouped under self-care. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-40 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831507|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Social Function|Primary caregiver-reported (through structured interview) child capabilities for 65 items of functional skills grouped under social function. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-65 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831508|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Mobility|Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831509|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Self-care|Primary caregiver-reported (through structured interview) child capabilities for 73 items of functional skills grouped under self-care. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-73 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831519|NCT00289991|Secondary|Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment|Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations. Subjects who developed a breakthrough proven or probable IFI were identified only from the study database, not the EORTC/MSG worksheet. In addition, all agents identified to be antifungals were considered to be systemic.|||percent of participants|||Number
2831510|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E|Total percent score on 24 items of GMFM grouped into Dimension E) walking, running, and jumping. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension E determined by dividing score obtained by maximum possible score for that dimension (72), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. E) walking, running, and jumping: (score achieved/72)x 100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831511|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D|Total percent score on 13 items of GMFM grouped into Dimension D) standing. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension D determined by dividing score obtained by maximum possible score for that dimension (39), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. D) standing: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831512|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C|Total percent score on 14 items of GMFM grouped into Dimension C) crawling and kneeling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension C determined by dividing score obtained by maximum possible score for that dimension (42), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. C) crawling and kneeling: (score achieved/42)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831513|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B|Total percent score on 20 items of GMFM grouped into Dimension B) sitting. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension B determined by dividing score obtained by maximum possible score for that dimension (60), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. B) sitting: (score achieved/60)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831514|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A|Total percent score on 17 items of GMFM grouped into Dimension A) lying and rolling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension A determined by dividing score obtained by maximum possible score for that dimension (51), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. A) lying and rolling: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831515|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure 66-Item Subscale Score (GMFM-66).|GMFM-66: total percent score on 66-item subscale of GMFM-88: Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score determined by dividing score obtained by maximum possible score for the 66 items, and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. GMFM-66: [(total score on subset of 66 items/198)x100].|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2831516|NCT00290186|Primary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).|"GMFM-88: total percent score on 88 items (I) of motor function grouped into 5 dimensions: A) lying and rolling (17 I), B) sitting (20 I), C) crawling and kneeling (14 I), D) standing (13 I), E) walking, running, jumping (24 I). Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scores in each dimension determined by dividing score obtained by maximum possible score for that dimension, and multiplying by 100. Range is 0-100% for each: the higher the percent score, the greater the functional ability.~Dimension scores and total GMFM-88 score calculated as:~A) lying and rolling: (score achieved/51)x100 B) sitting: (score achieved/60)x100 C) crawling and kneeling: (score achieved/42)x100 D) standing: (score achieved/39)x100 E) walking, running, and jumping: (score achieved/72)x 100 GMFM-88 = (%A+%B+%C+%D+%E)/number of dimensions GMFM-66: [(total score on subset of 66 items/198)x100]"|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).|||units on a scale||95% Confidence Interval|Mean
2841165|NCT00161382|Secondary|Barriers||Measured throughout the study|||||||
2831523|NCT00289991|Secondary|Survival: Percent of Subjects Who Died at or Before Day 180|Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis does not include any deaths recorded in the long-term follow-up data (not available at time of analysis).|||percent of participants|||Number
2831524|NCT00289991|Secondary|Percent of Subjects With Occurrence of Breakthrough IFI|Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.|Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on EORTC/MSG worksheets (not on Case Report Forms or in the database).|||percent of participants|||Number
2831525|NCT00289991|Secondary|Time to Breakthrough Invasive Fungal Infection (IFI)|Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) worksheets (not on Case Report Forms or in the database). Times were summarized only for subjects who experienced a breakthrough IFI.|||days||95% Confidence Interval|Mean
2831526|NCT00289991|Secondary|Success at Day 100: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).|Day 100 (Visit 7)|MITT; data from 1 site excluded due to GCP deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.|||percent of participants|||Number
2831527|NCT00289991|Primary|Success at Day 180: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).|Day 180 (Visit 9)|Modified Intent to Treat (MITT): primary analysis population; all randomized subjects: received at least 1 dose of randomized study drug and had allogeneic HSCT; data from 1 site excluded due to Good Clinical Practice (GCP) deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.|||percent of participants|||Number
2831528|NCT00289978|Secondary|Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline|The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.|||T2 lesions|Participants|Standard Deviation|Mean
2831529|NCT00289978|Secondary|Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2831530|NCT00289978|Primary|Estimated Annualized Aggregate Relapse Rate (ARR)|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.|Baseline to end of study (Month 24)|This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.|||Relapses per year||95% Confidence Interval|Number
2831531|NCT00289913|Primary|Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™|"GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.~IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.~IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.~IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL."|4 weeks postvaccination with Infanrix™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.|||ELISA units per mL (ELU/mL)||95% Confidence Interval|Geometric Mean
2831666|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||At Year 6, 7, 8, 9 and 10|The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2831532|NCT00289913|Primary|Number of Participants With Adverse Events (AE)|"Systemic and injection site AEs were collected from participants receiving~VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)~VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)~VAQTA™ administered alone (Stage II)~Safety data was collected on a standardized Vaccination Report Card (VRC)~following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE."|Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs|Participants administered at least one dose of vaccine, for whom follow-up was available.|||Participants|||Number
2831533|NCT00289913|Primary|Antibody Response Rate to Haemophilus Influenzae Type b (Hib)|"Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.~The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™."|4 weeks postvaccination with PedvaxHIB™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2831534|NCT00289913|Primary|Seropositivity Rate (SPR) to Hepatitis A|SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).|4 weeks after dose 2 of VAQTA™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2831535|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831536|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831537|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831538|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831539|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831540|NCT00289900|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831541|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831542|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831543|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831544|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831545|NCT00289900|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831546|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831547|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2831548|NCT00289900|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.|||Percentage of Participants|||Number
2833751|NCT00268450|Secondary|Urinary Survivin Levels||Baseline, week 6 and week 12|Data for this outcome measure was not collected||||||
2841166|NCT00161382|Secondary|Perceived Norms||Measured throughout the study|||||||
2831549|NCT00289900|Secondary|Percentage Change From Baseline in TC/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831550|NCT00289900|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP)|Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Median
2831551|NCT00289900|Secondary|Percentage Change From Baseline in Lipoprotein (a) (Lp[a])|Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Median
2831552|NCT00289900|Secondary|Percentage Change From Baseline in Total Cholesterol (TC)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831553|NCT00289900|Secondary|Percentage Change From Baseline in Apo A-I|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831554|NCT00289900|Secondary|Percentage Change From Baseline in Apolipoprotein (Apo) B|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831555|NCT00289900|Secondary|Percentage Change From Baseline in LDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831556|NCT00289900|Secondary|Percentage Change From Baseline in Non-HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831557|NCT00289900|Secondary|Percentage Change From Baseline in Triglycerides (TG)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Median
2831558|NCT00289900|Secondary|Percentage Change From Baseline in HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage change||95% Confidence Interval|Least Squares Mean
2831559|NCT00289900|Primary|Percentage Change From Baseline in the LDL-C/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2831560|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
2831561|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
2831667|NCT00289744|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration||Years 6, 7, 8, 9, and 10.|The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2841167|NCT00161382|Secondary|Attitudes||Measured throughout the study|||||||
2831562|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
2831563|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
2831564|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
2831565|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."|||mm Hg||Standard Error|Least Squares Mean
2831566|NCT00289874|Secondary|"Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period"|Percent change from baseline in average daily β-agonist use over the 3-week treatment period|Baseline and Week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).|||Percent Change||Standard Deviation|Median
2831567|NCT00289874|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|Percent change from baseline in FEV1, a measure of airway function, at Week 3|Baseline and week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).|||Percent Change||95% Confidence Interval|Least Squares Mean
2831568|NCT00289848|Secondary|Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2831569|NCT00289848|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2831570|NCT00289848|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.|||Percent||95% Confidence Interval|Least Squares Mean
2831571|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831572|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831573|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits|Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2833752|NCT00268450|Primary|Complete Remission Rate||From day of first treatment until after cycle 3|Data for this outcome measure was not collected||||||
2831574|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831575|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.|Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831576|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831577|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831578|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831579|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831580|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831581|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831582|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831583|NCT00289783|Secondary|Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination|Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within 43 days (Day 0 through Day 42) after vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831584|NCT00289783|Secondary|Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)|Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0 to Day 3) after fourth dose vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831585|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831586|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831587|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C|Within the 4 days (Day 0-3) post-vaccination period following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2833753|NCT00268437|Secondary|Overall Survival|Time from registration to death due to any cause.|From baseline to 4 years||||months||95% Confidence Interval|Median
2831588|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within the 4 days (Day 0-3) following each dose of the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831589|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day0-3) follow-up period after the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.|||Participants|||Count of Participants
2831590|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day 0-3) follow-up period after primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.|||Participants|||Count of Participants
2831591|NCT00289783|Secondary|Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40|"anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based."|Prior to the fourth dose vaccination and one month after the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831592|NCT00289783|Secondary|Anti-varicella Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||Titers||95% Confidence Interval|Geometric Mean
2831593|NCT00289783|Secondary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:40|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||Participants|||Count of Participants
2831594|NCT00289783|Secondary|Anti-rubella Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||IU/mL||95% Confidence Interval|Geometric Mean
2831595|NCT00289783|Secondary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010|||Participants|||Count of Participants
2831596|NCT00289783|Secondary|Anti-mumps Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Titers||95% Confidence Interval|Geometric Mean
2831597|NCT00289783|Secondary|Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values|"Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50.~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
2831663|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|At Year 6, 7, 8, 9 and 10|The analysis was performed on the long-term (LT) total vaccinated cohort.|||Participants|||Count of Participants
2831598|NCT00289783|Secondary|Anti-measles Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831599|NCT00289783|Secondary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
2831600|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831601|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2831602|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831603|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2831604|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831605|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|"hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria ) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose|||Participants|||Count of Participants
2831606|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course and prior to the fourth dose vaccination|The Fourth dose ATP cohort for safety included eligible subjects, who met inclusion criteria, who received 3 vaccine doses in the primary vaccination course, who received the fourth vaccine dose, who did not receive a vaccine not specified or forbidden and who were not excluded from from the Primary ATP cohort for immunogenicity.|||µg/mL||95% Confidence Interval|Geometric Mean
2831993|NCT00286754|Secondary|Change in Morisky Score From Baseline to 6 Months|Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent|baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
2831607|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value|"Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose.|||Participants|||Count of Participants
2831608|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2831609|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibodies Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2831610|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831611|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831612|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2831613|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titres are expressed as Geometric Mean Titers (GMTs).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2831614|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831717|NCT00289536|Secondary|Total Area Under the Moment Curve|Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour^2/dL||Full Range|Median
2831615|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831616|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2831617|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2831618|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831619|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831620|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2831621|NCT00289783|Secondary|Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831622|NCT00289783|Secondary|Anti-poliovirus Types 1, 2 and 3 Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2831699|NCT00289718|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||subjects|||Number
2831623|NCT00289783|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831624|NCT00289783|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2831625|NCT00289783|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831626|NCT00289783|Secondary|Anti-HBS Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL)~Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831627|NCT00289783|Secondary|Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)|"Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831628|NCT00289783|Secondary|Anti-D and Anti-T Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2831629|NCT00289783|Secondary|Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831630|NCT00289783|Primary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:5|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5.~Co-administration with Varivax vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
2831631|NCT00289783|Primary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL.~Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
2831632|NCT00289783|Primary|Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50~Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
2831994|NCT00286754|Secondary|Change in Number of Cardio Exercise Hours From Baseline to 6 Months||baseline and 6 months||||hours||95% Confidence Interval|Mean
2841168|NCT00161382|Secondary|Self-efficacy||Measured throughout the study|||||||
2831633|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831634|NCT00289783|Primary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~Co-administration with MMR-II vaccine"|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.|||Participants|||Count of Participants
2831635|NCT00289783|Primary|Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831636|NCT00289783|Primary|Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Participants|||Count of Participants
2831637|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Participants|||Count of Participants
2831638|NCT00289783|Primary|hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2831639|NCT00289783|Primary|hSBA-MenC Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2831640|NCT00289783|Primary|Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers are expressen as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2831641|NCT00289783|Primary|Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers were expressed as Geometric Mean Titers (GMTs)~This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
2831642|NCT00289783|Primary|Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2831995|NCT00286754|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Baseline and 6 months||||mm Hg||95% Confidence Interval|Mean
2831643|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|up to Year 11, 12, 13, 14, 15|Analysis was performed on the long-term (LT) Total Vaccinated Cohort, this included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling time-point and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
2831644|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
2831645|NCT00289770|Primary|Number of Subjects With Unsolicited Symptoms|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
2831646|NCT00289770|Primary|Number of Subjects With Solicited Local and General Symptoms Assessed|Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, fever, gastrointestinal, headache.|During the 4-day follow-up period after additional vaccination with Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
2831647|NCT00289770|Primary|Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response|"Anamnestic response was assessed in subjects receiving an additional vaccine dose of Engerix. Two subjects were found eligible at Year 11 for this additional vaccine dose.~Anamnestic response was defined as:~post-additional vaccination anti-HBs concentration >= 10 mIU/mL in subject seronegative before additional dose.~4-fold increase post-additional dose compared to pre-additional vaccine time point."|30 days post additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||Participants|||Count of Participants
2831648|NCT00289770|Primary|Anti-HBs Antibody Concentrations|"Subjects who lost seroprotective concentrations for anti-HBs (< 10 mIU/mL) at any of the LT follow-up timepoints received an additional dose of Engerix after year 15.~Two subjects were eligible for this after Year 11.~3.29 in the table means a concentration of < 3.3 mIU/mL.~As the concentration was calculated per subject no mean concentration was calculated and also no measure of dispersion."|at Year 11, pre-additional vaccine, after additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.|||mIU/mL|||Number
2831649|NCT00289770|Primary|Anti-HAV and Anti-HBs Antibody Concentrations|"Concentrations are expressed as geometric mean concentrations (GMCs) in mIU/mL.~The laboratory assay was changed from Year 13 to Year 14 to in-house ELISA and at Year 15 to CLIA for anti-HBs GMCs.Thus for the sake of bridging, blood samples corresponding to Year 14 previously tested with ELISA were re-tested with CLIA (Year 14*)."|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831650|NCT00289770|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values were defined 3.3 mIU/mL for the in-house anti-HBs assay and 6.2 mIU/mL for the ChemiLuminescence ImmunoAssay, which was also considered as seropositivity, and 10 mIU/mL.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.|||Participants|||Count of Participants
2831651|NCT00289770|Primary|Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value|Cut-off value was defined as 15 milli-international units per milliliter (mIU/mL). This was considered as seropositivity.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.|||Participants|||Count of Participants
2831664|NCT00289744|Primary|Number of Subjects With Immune Response to the Additional Dose of Engerix™-B|"Immune response was defined as:~anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points~at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
2831652|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the follow-up period after additional vaccination up to Year 20|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
2831653|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Grade AE = produced significant impairment of functioning or incapacitation and was a definite hazard to the subject's health.~Related AE = assessed by the investigator as related to the study vaccination."|During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
2831654|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed included fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
2831655|NCT00289757|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain = symptom that prevented normal activities. Grade 3 redness and swelling = redness or swelling above 30 mm and persisting more than 24 hours.~Any = incidence of a particular symptom regardless of intensity."|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||Subjects|||Number
2831656|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term Total cohort which included all subjects who returned to the follow-up study and who had received at least 1 dose of the vaccine in the primary study.|||Subjects|||Number
2831657|NCT00289757|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies.|"Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points.~The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|From Year 11 to Year 20|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.|||Subjects|||Number
2831658|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL.|Before the additional dose, 14 days and 30 days after the additional dose|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|||mIU/mL|||Number
2831659|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).~The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831660|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
2831661|NCT00289744|Primary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
2831662|NCT00289744|Primary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.|During the 4-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.|||Participants|||Count of Participants
2831665|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||Before and 1 month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2841169|NCT00161382|Secondary|Knowledge||Measured throughout the study|||||||
2831668|NCT00289731|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed on the Long Term Total Vaccinated Cohort, which included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the current blood sample time point at one, two and three years (Month 12, 24, 36) after first vaccination.|||Participants|||Count of Participants
2831669|NCT00289731|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.|From Day 0 up to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2831670|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed on the LT ATP cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831671|NCT00289731|Secondary|Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed on the LT ATP cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.|||Participants|||Count of Participants
2831672|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).|At Month 12 (M12), Month 24 (M24) and Month 36 (M36)|The analysis was performed Long Term According-To-Protocol (LT ATP) cohort for immunogenicity, which included all subjects who were included in the ATP cohort for immunogenicity in the primary study and who came within the blood sampling time interval at Months 12, 24 and 36.|||Participants|||Count of Participants
2831673|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831674|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by concomitant medication (concomitant medication and no concomitant medication).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831675|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by alcohol consumption as follows: none or mild, moderate and heavy.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831676|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by smoking status (smokers and non-smokers).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831700|NCT00289718|Primary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination.|During the 4-day (Day 0-3) follow-up period after additional HBV vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||Subjects|||Number
2831677|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by BMI|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by BMI as follows: healthy, overweight and obese.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831678|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Age|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831679|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations, by Gender|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. The antibody concentrations were stratified by gender (females and males).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831680|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831681|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831682|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831683|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by smoking status (smokers and non-smokers).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831684|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by BMI|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831685|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Age|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831686|NCT00289731|Secondary|Number of Seroprotected Subjects Against HBs Antigen, by Gender|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. The seroprotection rates were stratified by gender (females and males).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831687|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831716|NCT00289536|Secondary|Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||mL/kg*hour||Full Range|Median
2831688|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by concomitant medication (concomitant medication and no concomitant medication).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831689|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by alcohol consumption as follows: None or Mild, Moderate and Heavy.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831690|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by smoking status (smokers and non-smokers).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831691|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by BMI as follows: healthy, overweight and obese.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831692|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831693|NCT00289731|Secondary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. The seropositivity rates were stratified by gender (females and males).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831694|NCT00289731|Secondary|Anti-HAV and Anti-HBs Antibody Concentrations|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831695|NCT00289731|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen|A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831696|NCT00289731|Primary|Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value|Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2831697|NCT00289731|Primary|Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens|Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.|At Month 7 after Twinrix vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2831698|NCT00289718|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the LT Total Cohort that included all subjects who returned at a specified follow-up study and who belonged to the Total Cohort of the primary vaccination course.|||Subjects|||Number
2831701|NCT00289718|Primary|Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.|Before the additional dose and 1 month after the additional dose|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||mIU/mL|||Number
2831702|NCT00289718|Primary|Number of Subjects Reporting Serious Adverse Events (SAE)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the follow-up period after additional vaccination (minimum 30 days)|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||subjects|||Number
2831703|NCT00289718|Primary|Number of Subjects Seroprotected for Anti-HBs Antibodies.|"A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL.~NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)"|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||Subjects|||Number
2831704|NCT00289718|Primary|Number of Subjects Seropositive for Anti-HB Antibodies|"A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL.~NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)"|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||Subjects|||Number
2831705|NCT00289718|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL.|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||mIU/mL||95% Confidence Interval|Geometric Mean
2831706|NCT00289718|Primary|Number of Subjects Seropositive for Anti-HAV Antibodies|A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml.|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||Subjects|||Number
2831707|NCT00289718|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Day 0-3) follow-up period after additional HBV vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.|||subjects|||Number
2831708|NCT00289718|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).|At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint|||mIU/mL||95% Confidence Interval|Geometric Mean
2831709|NCT00289653|Secondary|Smoking Cessation|self reported # cigarettes per day|Week 10||||cigarettes per day||Standard Deviation|Mean
2831710|NCT00289653|Primary|Carbon Monoxide Levels|Expired Co levels were measured to confirm smoking status|measured at week 10||||parts per million||Standard Deviation|Mean
2831711|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Antigen (VWF:Ag)|Percentage of VWF:Ag. Relationships between baseline VWF:Ag and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s).|||U/dL||Full Range|Median
2831712|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Ristocetin Cofactor Activity (VWF:Rco)|Percentage of normal VWF:Rco activity. Normal is a lab standard consisting of a non-hemophilic population. Relationships between baseline VWF:Rco and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s)|||Percent of normal VWF:Rco activity||Full Range|Median
2831713|NCT00289536|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration after infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU/dL||Full Range|Median
2831714|NCT00289536|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted CL * Mean Residence Time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||dL/kg||Full Range|Median
2831715|NCT00289536|Secondary|Mean Residence Time|Computed as total AUMC divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||hour||Full Range|Median
2831718|NCT00289536|Secondary|Total Area Under the Curve|Total AUC with extrapolation using the slope of the β-phase|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour/dL||Full Range|Median
2831719|NCT00289536|Secondary|Area Under the Curve|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour/dL||Full Range|Median
2831720|NCT00289536|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||hour||Full Range|Median
2831721|NCT00289536|Secondary|Area Under the Curve/Dose|Area under the plasma factor VIII concentration versus time curve (AUC) estimated by linear trapezoidal method per dose.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU*hour/dL per IU/kg||Full Range|Median
2831722|NCT00289536|Primary|Initial Recovery|Percent increase in factor VIII concentration per dose from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.|||IU/dL per IU/kg||Full Range|Median
2831723|NCT00289471|Primary|Performance Characteristics|Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment|Cross-sectional [at baseline; no longitudinal component]||||Percentage of participants||95% Confidence Interval|Number
2831724|NCT00289458|Primary|Change in Dual Task Function|change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)|baseline and 11 weeks||||unit of scale (seconds)||Standard Deviation|Mean
2831725|NCT00289458|Secondary|Change in Physical Activity|change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)|baseline and 11 weeks||||unit of scale||Standard Deviation|Mean
2831726|NCT00289458|Primary|Change in Falls-Efficacy|change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)|baseline and 11 weeks|ITT and LOCF|||unit of scale||Standard Deviation|Mean
2831727|NCT00289458|Primary|Change in Walking|change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks|baseline and 11 weeks|ITT and LOCF|||unit of scale (meters per 6 minutes)||Standard Deviation|Mean
2831728|NCT00289458|Primary|Change in Chair Stands|change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)|baseline and 11 weeks|ITT and LOCF|||number of stands per 30 seconds||Standard Deviation|Mean
2831729|NCT00289458|Primary|Change in Balance|Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)|baseline and 11 weeks|ITT and LOCF|||units on a scale||Standard Deviation|Mean
2831730|NCT00289341|Secondary|Change in PSA Slope, Pre- vs Post-vaccination.|To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used. Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase. To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model. For the general model, random effects for the intercept, slope and the first knot were considered.|pre- vs post- vaccination PSA slopes.|23 of 24 patients were analyzed. 1 patient was not evaluable.|||log₂(ng/ml)/month||95% Confidence Interval|Number
2831731|NCT00289341|Primary|"Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The Number Indicated is the Median Difference of Post-Pre, of Each Antigen Group."|The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.|pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13|The Arm/Group Title is different for this outcome. In the 1st outcome analysis, AEs were being compared between placebo and tx groups. After the blinded phase, placebo pts crossover and we compare pre-vs post vaccination T cell proliferation in all pts. 22 of 24 pts'assays were analyzed. Two were excluded as they failed internal controls.|||cells *10^3 per minute||95% Confidence Interval|Median
2831732|NCT00289341|Primary|Adverse Event|Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.|End of blinded phase (wk 9)|All AEs occurring 5 or more times during the study were analyzed. All AEs reported are grade 1 except as noted.|||Adverse Events|||Number
2831733|NCT00289315|Primary|BMI Z-score (Girls)|Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean|Baseline and three years|primary preventions, primary + secondary prevention, control group (girls)|||z score||Standard Error|Mean
2831734|NCT00289315|Primary|% Body Fat (Girls)|change in percent body fat between Baseline and 3 years for girls|Baseline and 3 years|children in primary prevention, primary + secondary prevention, and control group (girls)|||percentage of body fat||Standard Error|Mean
2831778|NCT00289185|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability, and loss of appetite. Fever was defined as axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C).|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2831735|NCT00289315|Primary|BMI Z-score (Boys)|Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean|Baseline and three years|primary preventions, primary + secondary prevention, control group (boys)|||z score||Standard Error|Mean
2831736|NCT00289315|Primary|% Body Fat (Boys)|change in percent body fat between Baseline and 3 years for boys|Baseline and 3 years|children in primary prevention, primary + secondary prevention, and control group (boys)|||percentage of body fat||Standard Error|Mean
2831737|NCT00289289|Secondary|Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden|AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.|6 months (per Intervention)|Of the 256 randomized to ON-OFF or OFF-ON programming, 225 had device data necessary for computing AT/AF burden in both randomized study periods.|||hours per day||Standard Deviation|Mean
2831738|NCT00289289|Secondary|Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)|The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.|6 months (per Intervention)|All randomized subjects with follow-up during intervention pacing feature programming period.|||Months||Standard Deviation|Mean
2831739|NCT00289289|Secondary|Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist|The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.|6 months (per Intervention)|Of the 256 randomized subjects only 211 completed the AF symptom checklist at both the 9-month and 15-month visit. Since this was a crossover study, data from both visits was required for the subject to be included in the analysis|||Scores on a scale||Full Range|Median
2831740|NCT00289289|Primary|Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month|The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed|6-months (per Intervention)|Patient Assistant data which contained markers for symptomatic atrial tachycardia or atrial fibrillation episodes obtained from save-to-disk data was required from both randomized follow-up periods (3-9 months and 9-15 months) for the subject to be included in the primary ITT analysis.|||Episodes per subject per month||Standard Deviation|Mean
2831741|NCT00289276|Secondary|Number of Adverse Events|All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|From enrollment to study exit (up to 36 months).|Number of participants analyzed for this outcome is limited to subjects who experienced at least one Adverse Event from enrollment to study exit.|||Adverse Events|||Number
2831742|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF|Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.|1 day pre and 1 day post-outpatient visit|All subjects with at least one heart failure outpatient treatment and with impedance data pre and post-outpatient treatment.|||Ohms||Full Range|Mean
2831743|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF|Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.|3 days pre-admission and 3 days post-discharge|All subjects with at least one heart failure hospitalization and with impedance data pre and post-hospitalization.|||Ohms||Full Range|Mean
2831744|NCT00289276|Primary|Number of Subjects With at Least 30 Days of Daily Impedance Measurements|Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.|Up to 36 months.|Includes all enrolled participants.|||participants|||Number
2831745|NCT00289211|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.|||mg/dL||Standard Deviation|Mean
2831746|NCT00289211|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.|||percent of functional C1INH||Standard Deviation|Mean
2831747|NCT00289211|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.|||mg/dL||Standard Deviation|Mean
2831748|NCT00289211|Secondary|Time to Complete Resolution of the HAE Attack|Randomized subjects were contacted 72-96 hours (3-4 days) after discharge from the study site to determine when complete resolution of the HAE attack occurred.|72 hours|ITT Population.|||hours||95% Confidence Interval|Median
2831996|NCT00286754|Secondary|Change in Proportion With BP Under Control From Baseline to 6 Months||6 months||||Proportion of participants|||Number
2831997|NCT00286754|Primary|Systolic Blood Pressure|Mean systolic Blood Pressure|6 months||||mm Hg||95% Confidence Interval|Mean
2831749|NCT00289211|Secondary|Number of Subjects With Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-Efficacy (ITT-E) Population (N=68; 3 of the 71 randomized [ie, ITT] subjects were excluded from the ITT-E Population, as it was later determined that they did not experience a definitive hereditary angioedema [HAE] attack).|||participants|||Number
2831750|NCT00289211|Primary|Time to Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|Intent-to-treat (ITT) Population (all randomized subjects). Since less than 50% of subjects in the placebo group achieved the endpoint, median time to event was not estimable (NE). Further, the number of censored events in the C1INH-nf and placebo groups precluded estimation of the 95% confidence interval (CI) upper bound for median time to event.|||hours||95% Confidence Interval|Median
2831751|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period|The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Liters per minute||Standard Error|Least Squares Mean
2831752|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period|PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Liters per minute||Standard Error|Least Squares Mean
2831753|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period|PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Liters per minute||Standard Error|Least Squares Mean
2831754|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period|IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831755|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period|rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831779|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the TETRActHib vaccine..|Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2831998|NCT00286754|Primary|Blood Pressure Control|Blood pressure Control at 6 months|6 months||||proportion of participants|||Number
2831756|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period|IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831757|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period|Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831758|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period|The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831759|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period|The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Deviation|Mean
2831760|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period|The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831761|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period|TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Deviation|Mean
2831762|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period|rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population|||Scores on a scale||Standard Error|Least Squares Mean
2831763|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment|INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831764|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period|The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831765|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period|The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.|Baseline (Day 1) and up to 6 weeks|ITT population. Only those participants available at the time of assessment were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2831766|NCT00289198|Secondary|Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value*100.|Baseline and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Percent change||Standard Error|Least Squares Mean
2831767|NCT00289198|Secondary|Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Percent change||Standard Error|Least Squares Mean
2831768|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831777|NCT00289185|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2842377|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12||||L||Standard Error|Mean
2831769|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831770|NCT00289198|Secondary|Number of Participants With Response to Therapy Over Entire Treatment Period|Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.|Up to 6 weeks|ITT population. Data is presented for the participants available at the time of assessment.|||Participants|||Number
2831771|NCT00289198|Secondary|Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period|The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and up to Week 6|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831772|NCT00289198|Primary|Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed|Baseline (Day 1) and up to Week 6|ITT population. Data is presented for the participants available at the time of assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2831773|NCT00289185|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (Subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 7 months after administration of Dose 3 of RTS,S or HBV vaccine (Month 9). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. This outcome for solely assessed in the Engerix-B Group, as no subject in the RTS,S/AS02D was assessed as prevalent for parasitemia.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.|||Parasite per microliter (µL)||Full Range|Mean
2831774|NCT00289185|Secondary|Number of Subjects Prevalent for Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.|||Subjects|||Number
2831775|NCT00289185|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.|||n/PYAR|||Number
2831776|NCT00289185|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study, from Week 0 to Month 20.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
2831999|NCT00286741|Secondary|Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).||one year|Analysis was not performed - project staff and data no longer available.||||||
2831780|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the RTS,S/AS02D or Engerix-B vaccine.|Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2831781|NCT00289185|Secondary|Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of 0.5 EL.U/mL.|Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||ELISA unit per milliliter||95% Confidence Interval|Geometric Mean
2831782|NCT00289185|Primary|Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subjects|||Number
2831783|NCT00289185|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subjects|||Number
2831784|NCT00289185|Primary|Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subject|||Number
2831785|NCT00289185|Primary|Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subject|||Number
2831786|NCT00289185|Primary|Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||Subject|||Number
2831787|NCT00289185|Primary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||ELISA unit per millilite||95% Confidence Interval|Geometric Mean
2831788|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 9 to Month 20.||||Subject|||Number
2831789|NCT00289185|Primary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||international unit per milliliter||95% Confidence Interval|Geometric Mean
2831790|NCT00289185|Primary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||international unit per milliliter||95% Confidence Interval|Geometric Mean
2831791|NCT00289185|Primary|Concentrations of Antibodies Against Diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||international unit per milliliter||95% Confidence Interval|Geometric Mean
2831792|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Week 0 to Month 9.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
2831793|NCT00289185|Primary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||milli-international unit per milliliter||95% Confidence Interval|Geometric Mean
2831794|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
2831795|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
2831796|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
2831797|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||percentage of knees|Knees||Number
2831798|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores (points) on a scale|Knees|Standard Deviation|Mean
2831799|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores (points) on a scale|Knees|Standard Deviation|Mean
2831800|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores on a scale|Knees|Standard Deviation|Mean
2831801|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.|||scores on a scale|Knees|Standard Deviation|Mean
2831802|NCT00289133|Primary|Survivorship (Revision of Any Component for Any Reason)|Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 years|Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.|||percentage of knees|number of knees|95% Confidence Interval|Number
2832000|NCT00286741|Primary|Systolic Blood Pressure||12 months||||mmHg||Standard Deviation|Mean
2832001|NCT00286741|Primary|Hemoglobin A1c||12 months||||percentage points||Standard Deviation|Mean
2831803|NCT00289120|Primary|The Plasma and Urine Parameters|"The Urine Parameters that were assessed at the end of cola and water (arms) phase:~Urine Parameters:~uNa (mEq per d) uK (mEq per d)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase||||mEq per d||Standard Deviation|Mean
2831804|NCT00289120|Secondary|Urinary pH|"The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase||||pH||Standard Deviation|Mean
2831805|NCT00289120|Secondary|Total Urine Volume|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Urine Parameters:~Total Urine Volume (mL/day)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase||||mL/day||Standard Deviation|Mean
2831806|NCT00289120|Primary|The Plasma Osmolarity|"The Plasma osmolarity that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~OSM (mOsm/L)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of cola and water phase||||mOsm/L||Standard Deviation|Mean
2831807|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase||||mEq/L||Standard Deviation|Mean
2831808|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL)~Urine Parameters:~uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase||||mg per dL||Standard Deviation|Mean
2831809|NCT00289107|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
2831810|NCT00289107|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
2831811|NCT00289107|Secondary|Revisions||On-going to end of study|||||||
2831812|NCT00289107|Secondary|Complications||On-going to end of study|||||||
2831813|NCT00289107|Primary|Knee Society Score|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||Scores on a scale||Standard Deviation|Mean
2831814|NCT00289094|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
2831815|NCT00289094|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||||||
2831816|NCT00289094|Secondary|Complications/Revisions||On-going to end of study.|||||||
2831817|NCT00289094|Primary|Knee Society Scores|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||Scores on a scale||Standard Deviation|Mean
2831818|NCT00289016|Secondary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).~Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days.|ITT population|||participants|||Number
2831819|NCT00289016|Secondary|Duration of Response|Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)|||days||Full Range|Median
2831820|NCT00289016|Secondary|Time to Longest Continuous Response|Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant's last response interval.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)|||days||Full Range|Median
2831821|NCT00289016|Secondary|Time to Progression|"Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease.~Median time to progression was calculated using the Kaplan-Meier method."|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population|||days||Full Range|Median
2831822|NCT00289016|Secondary|Overall Survival|Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|ITT population|||days||Full Range|Median
2831823|NCT00289016|Primary|Objective Tumor Response Rate|"Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart.~Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:~Complete response (CR): zero tumor burden~Partial response (PR): a 30% or greater decrease in tumor burden~Progressive disease (PD): a 20% or greater increase in tumor burden~Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec)|||percentage of participants|||Number
2831824|NCT00288912|Secondary|Arthritis Self Efficacy|The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2831825|NCT00288912|Secondary|AIMS 2 Affect|"The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (all days to no days). Scores can range from 0-10, with higher scores indicating worse affect."|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2831826|NCT00288912|Secondary|AIMS 2 Physical Function|"The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (all days to no days). Scores can range from 0-10, with higher scores indicating worse function."|Baseline and 12-month follow-up||||units on a scale||Standard Deviation|Mean
2831827|NCT00288912|Primary|Pain|"Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (all days to no days). The possible range of scores is 0-10, with higher scores indicating more severe pain."|Baseline and 12-month follow-up||||units on a scale||Standard Deviation|Mean
2831828|NCT00288886|Secondary|Rates of Hospitalization (Across the Prior 90 Days)|Number of days hospitalized for any reason per the previous 90 days|Assessed at Baseline, 3-, 6-, and 12-months||||days||Standard Deviation|Mean
2831829|NCT00288886|Secondary|Days of Substance Abuse (Across the Prior 90 Days)||Assessed at Baseline, 3-, 6-, and 12-month follow-up||||percentage of 90 days||Standard Deviation|Mean
2831830|NCT00288886|Secondary|Self-help Support Group Attendance||Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year||||days||Standard Deviation|Mean
2831831|NCT00288886|Secondary|Aftercare Attendance|Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment)|Assessed at 3-, 6-, 9-, and 12-months||||percentage of participants|||Number
2831832|NCT00288886|Secondary|Days Until First Use of Alcohol or Drugs||Baseline to 12 months||||days||Standard Deviation|Mean
2831833|NCT00288886|Secondary|Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 3 and 6 months||||participants|||Number
2831834|NCT00288886|Primary|Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 12 months||||participants|||Number
2831835|NCT00288860|Primary|Rehospitalization|Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program|12 months post discharge||||participants|||Number
2832002|NCT00286728|Secondary|Mental Health Services Use and Costs at 6 Months, 1 Year, and 2 Years||6 months, 1 year, 2 years|Access to data is no longer available.||||||
2831836|NCT00288860|Secondary|Depressive Symptoms, Subjective Quality of Life|Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)|12 months post-discharge (8 months post intervention)||||units on a scale||Standard Deviation|Mean
2831837|NCT00288860|Primary|Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms|"Higher scores are worse outcomes on all four measures:~Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)"|12 months post-discharge (8 months post intervention)||||Scores on a scale||Standard Deviation|Mean
2831838|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Number of Disease Flare Days|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.~A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue)."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.|||Number of Days||Standard Deviation|Mean
2831839|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that FCAS/MWS affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement.~OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.|||Units of a Scale||Standard Deviation|Mean
2831840|NCT00288704|Other Pre-specified|Summary of Mean Change From Baseline to Open-Label Extension Week 72 in KSS|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.~The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).~A negative change in mean values indicated improvement in symptoms."|From Baseline (week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.|||Units of a scale||Standard Deviation|Mean
2831841|NCT00288704|Other Pre-specified|Number of Subjects With at Least 75% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)||||Participants|||Number
2831842|NCT00288704|Other Pre-specified|Number of Subjects With at Least 50% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)||||Participants|||Number
2831843|NCT00288704|Other Pre-specified|Number of Subjects With at Least 30% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Endpoint (Week 6)||||Participants|||Number
2831844|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in Serum Amyloid A (mg/L)|An abnormal value for SAA was considered > 6.4 mg/L.|Baseline to Endpoint of Part A||||Milligrams per Liter||Standard Deviation|Median
2831845|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in C-Reactive Protein (mg/L)|An abnormal value for CRP was considered > 8.4 mg/L.|Baseline to Endpoint of Part A||||Milligrams per Liter||Standard Deviation|Median
2831846|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that Familial Cold Autoinflmatory Syndrome (FCAS) /Muckle-Wells Syndrome (MWS) affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement."|Baseline to Week 6 (Part A)||||Visual Analog Scale||Standard Deviation|Mean
2831847|NCT00288704|Other Pre-specified|Change From Baseline to Endpoint (Week 6) in Physician's Global Assessment|The Physician's Global Assessment was an evaluation at each visit on a scale of 0=no disease activity to 10=severe disease activity. A negative value in change in Physician's Global Assessment is indicative of an improvement.|Baseline to Week 6 (Part A)||||Units of a Scale||Standard Deviation|Mean
2831848|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Number of Disease Flare Days Per Patient|"A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The KSS was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was calculated for 21 Day Periods at baseline and at the endpoint (from Weeks 3 - 6). The difference in the number of flares between the two periods was averaged for all subjects.~The DHAF was used because it is a validated instrument to collect subject's self-reported responses. It was the basis for the KSS and the flare day count."|Baseline to Week 6 (Part A)||||Days||Standard Deviation|Mean
2832003|NCT00286728|Primary|Psychiatric Functioning at 6 Months|Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.|6 months|Explanation of Ns discrepant with patient flow: Ns with psychiatric severity scores at 6 months differ from those having completed the study at 2 years.|||units on a scale||Standard Deviation|Mean
2831849|NCT00288704|Primary|Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B)|"The mean Key Symptom Score (KSS --from the validated, patient-administered DHAF) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).~Subjects all received rilonacept 160 mg from week 6 through week 14. At week 15, subjects were re-randomized in a 1:1 ratio between Placebo and rilonacept 160 mg. Subjects baseline period was the 21-day period prior to week 15 randomization.~A positive score indicated a worsening of symptoms versus an active treatment rilonacept baseline period."|Week 15 through Week 24 (randomized withdrawal)|Subjects were re-randomized as part of the randomized withdrawal period (Part B). Subjects were not necessarily assigned the same treatment as in the first double-blind portion (Part A). Subjects were analyzed using last observation carried forward.|||Units of a Scale||Standard Deviation|Mean
2831850|NCT00288704|Primary|Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS)|"The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was averaged over two 21-day daily reporting periods (the 3 weeks prior to both baseline and week 6). In part A, a negative change in mean values indicated improvement under treatment with rilonacept in symptoms.~The DHAF was used because it is a validated instrument to collect subject's self-reported responses."|Baseline (Days -21 to -1) and Week 6 (Days 21-42)|Cryopyrin Associated Autoinflammatory Syndrome (CAPS) is a rare, orphan, hereditary disease. There are several hundred CAPS cases in the United States.|||Units of a Scale||Standard Deviation|Mean
2831851|NCT00288639|Secondary|Subjects Assessment of Optimal Sleep|Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.|Baseline, End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).|||participants|||Number
2831852|NCT00288639|Secondary|Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline|Count of subjects with a weight gain of at least 7 percent relative to baseline.|Baseline, End of 21-week treatment|"Safety population (all subjects who had taken at least~1 dose of study drug)."|||participants|||Number
2831853|NCT00288639|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.|Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.|Baseline, End of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."|||score on scale||95% Confidence Interval|Mean
2831854|NCT00288639|Secondary|Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores|Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1.|Baseline, end of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."|||score on scale||95% Confidence Interval|Mean
2831855|NCT00288639|Secondary|Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)|The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).|||partcipants|||Number
2831856|NCT00288639|Secondary|Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)|The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).|||participants|||Number
2831857|NCT00288639|Secondary|Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency|Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline observation period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) (all subjects who received at least 1 dose of study treatment & minimum 2 partial seizures during baseline pd). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||percentage change in events||Full Range|Median
2831858|NCT00288639|Secondary|Subjects Achieving Seizure Freedom During Observation Period|Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.|Day 147 from the first dose of study drug|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).|||participants|||Number
2831859|NCT00288639|Secondary|Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.|Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.|8 week baseline observation period & last 4 weeks of observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Patients who discontinued less than 4 weeks into the observation period (after Visit 3/week 9) will be regarded as missing. No data prior to week 9 will be used.|||participants|||Number
2836655|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Daytimes|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
2831860|NCT00288639|Secondary|Number of Subjects Seizure-free|Count of subjects seizure free during the period.|last 4 weeks & whole 12 week treatment observation period|Full analysis set(FAS)/intent-to-treat(ITT) all subjects who received >= 1 dose of study Tx & >= 2 partial seizures during baseline pd. LOCF if subjects withdrew then last 4 wks prior to last dose (but after visit 3). 12 wk subjects who withdrew were regarded as missing. n= # subjects evaluable for seizure freedom during defined observation pd.|||participants|||Number
2831861|NCT00288639|Post-Hoc|Change in Partial Seizure Frequency by Type Between the 8 Week Baseline Period and During the 12 Week Observation Period.|Change from baseline = 12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate.|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||change in median partial seizures||Full Range|Median
2831862|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.|Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure date from patients who discontinued during any of these 4 week intervals will not be included in the summary for that interval.|||percentage change of events||Full Range|Median
2831863|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.|Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||percentage change in events||Full Range|Median
2831864|NCT00288639|Primary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period|Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.|||percentage change in events||Full Range|Median
2831865|NCT00288626|Secondary|Percent Change From Screening in Brain Volume|Magnetic resonance imaging (MRI) scan techniques measured ventricular volumes and grey and white matter brain volumes. Change from screening was computed as the value at the time point minus the screening value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Percent Change||Standard Deviation|Mean
2831866|NCT00288626|Secondary|Change From Baseline in T1-Weighted Lesion Volume|A T1-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T1 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||milliliter||Standard Deviation|Mean
2831867|NCT00288626|Secondary|Change From Baseline in T2-Weighted Lesion Volume|A T2-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T2 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||milliliters||Standard Deviation|Mean
2831868|NCT00288626|Secondary|Number of New T2-Weighted Lesions From Baseline|A T2-weighted magnetic resonance imaging (MRI) scan was used to determine the number of new T2 lesions in the brain relative to Baseline. A value of 0 means that the participant didn't worsen. Values greater than 0 indicate an increase in disease activity from baseline.|6 Months to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Lesions per scan||Standard Deviation|Mean
2831869|NCT00288626|Secondary|Change From Baseline in Number of Gadolinium-Enhanced Lesions|Multiple sclerosis disease-related lesions were assessed by gadolinium-enhanced magnetic resonance imaging (MRI). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|8 weeks to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Lesions per scan||Standard Deviation|Mean
2831870|NCT00288626|Secondary|Change From Baseline in Extended Disability Status Scale (EDSS)|Kurtzke's Expanded Disability Status Scale (EDSS) assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. A change of > 0.5 in EDSS was a treatment-failure criterion.|6 months to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||units on a scale||Standard Deviation|Mean
2834488|NCT00262522|Primary|Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks||Week 8|All randomized subjects who received at least 1 dose of study drug.|||Percentage of Subjects|||Number
2831871|NCT00288626|Secondary|Disease-Modifying Therapy Survival Probability After Transplant|Treatment with disease-modifying therapy was measured by the number of days from transplant to the first treatment with an additional disease-modifying therapy. Examples of therapy include interferon beta-1a, glatiramer acetate, natalizumab, alemtuzumab, other immunosuppressive medications, or experimental therapies directed against MS activity. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error.|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2831872|NCT00288626|Secondary|MS Relapse-Free Survival Probability After Transplant|"MS clinical relapse is defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit or disability, and lasting over 48 hours. Clinical relapse was determined by the participant's neurologist and was measured as days from transplant to new or worsening neurological symptom relative to baseline.~Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error."|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2831873|NCT00288626|Secondary|MRI Activity-Free Survival Probability After Transplant|MS disease activity is measured as days from transplant to first occurrence of >= 2 new MS lesions on Magnetic resonance imaging (MRI) relative to baseline. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error.|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2831874|NCT00288626|Secondary|MS Progression-Free Survival Probability After Transplant|"MS progression is measured as number of days from transplant to first Kurtzke's Expanded Disability Status Scale (EDSS) increase of more than 0.5 relative to the baseline measurement. EDSS assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS).~Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error."|1 to 5 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2831875|NCT00288626|Secondary|Event-Free Survival Probability After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error.|1, 2, and 4 years after HCT|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2831876|NCT00288626|Secondary|Time to Platelet Engraftment|Platelet engraftment, or platelet count recovery, is defined as Platelets > 20,000/μL for two consecutive measurements on different days with no platelet transfusions in the preceding 7 days. Normal range is 150,000-450,000/μL. Reference: http://www.hopkinsmedicine.org/heart_vascular_institute/clinical_services/centers_excellence/womens_cardiovascular_health_center/patient_information/health_topics/platelets.html.|From time of graft infusion to time of engraftment, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Days||Standard Deviation|Mean
2831877|NCT00288626|Secondary|Time to Neutrophil Engraftment|Neutrophil engraftment, or neutrophil count recovery, is defined as an Absolute Neutrophil Count (ANC) > 500/ μL for 2 consecutive measurements on different days. Normal range is 1500 to 8000/μL. Reference: http://www.medicinenet.com|From time of graft infusion to time of engraftment, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Days||Standard Deviation|Mean
2831878|NCT00288626|Secondary|Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT|Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher.|From the time of Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) to 1 year after HCT.|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Percentage of Participants|||Number
2831879|NCT00288626|Secondary|Percent of Participants Who Experienced All-Cause Morbidity|Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher.|From the time of enrollment until completion of the 5-year follow-up, an average of 6 years.|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||percentage of participants|||Number
2831880|NCT00288626|Secondary|Survival From MS-Related Mortality|The probability that a participant did not experienced a MS-related death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood's formula for standard error was used to calculate 90% confidence intervals. Participants that did not experience a MS-related death were censored at the time of last follow-up. A MS-related death was defined as death that occurred at any time after study entry and that was possibly, probably, or definitely related to disease progression.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2832304|NCT00285012|Secondary|Number of Subjects With Long Term Quit Rate (LTQR)|"Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).~CO confirmed in-clinic visit."|Week 24, Week 52|All subjects population|||participants|||Number
2831881|NCT00288626|Secondary|Overall Survival|The probability that a participant did not experienced a death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood's formula for standard error was used to calculate 90% confidence intervals. Participants that did not die were censored at the time of last follow-up.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT)|||Probability||90% Confidence Interval|Number
2831882|NCT00288626|Secondary|Survival From Treatment-Related Mortality|The probability that a participant did not experienced a treatment-related death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood's formula for standard error was used to calculate 90% confidence intervals. Participants that did not experience a treatment-related death were censored at the time of last follow-up. A treatment-related death was defined as death that occurred at any time after study entry and that was possibly, probably, or definitely related to the cellular product or possibly, probably, or definitely related to mobilization of autologous peripheral blood hematopoietic progenitor cells with G-CSF and prednisone or to the high-dose immunosuppressive therapy. There were no treatment-related mortality events in the study.|From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Probability||90% Confidence Interval|Number
2831883|NCT00288626|Secondary|Event-Free Survival Probability During the 3 Years After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error.|3 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Probability||90% Confidence Interval|Number
2831884|NCT00288626|Primary|Event-Free Survival Probability During the 5 Years After Transplant|Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error.|5 years|Participants who received High-Dose Immunosuppressive Therapy (HDIT) and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT).|||Probability||90% Confidence Interval|Number
2831885|NCT00288600|Primary|Need of Exchange Transfusion|NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES|10 DAYS OF LIFE|NUMBER|||participants|||Number
2831886|NCT00288587|Secondary|Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths|Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.|Hospital discharge to 90 days after discharge|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.|||participants|||Number
2831887|NCT00288587|Secondary|Volume Removal Rate.|Hours of therapy required to remove 1 liter of fluid normalized to body weight.|Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.|||milliliters/hour/kilogram||Standard Deviation|Mean
2831888|NCT00288587|Secondary|Total Volume Removal During the Intervention Period||Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.|||milliliters||Standard Deviation|Mean
2831889|NCT00288587|Secondary|Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.||Time from admission to endpoint achievement|The analysis population was the intent-to-treat group, represented by all patients enrolled in this study.|||Days||Standard Deviation|Mean
2831890|NCT00288587|Primary|Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.||4 consecutive hours (+/- 30 minutes)|Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study.|||hours||Standard Deviation|Mean
2831891|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Yale Brown Cornell Obsessive Compulsive Scale for Eating Disorders (YBC-EDS)|The YBC-EDS is an eight item, clinician-rated instrument assessing eating related preoccupations and/or rituals. Possible scores range from 0 to 32, with higher scores indicating greater preoccupations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831892|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Perfectionism Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Perfectionism subscale is comprised of six items Indicating excessive personal expectations for superior achievement. Possible scores range from 0 to 18, with higher scores indicating greater expectations. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2832004|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2831893|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Body Dissatisfaction Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Body Dissatisfaction subscale is comprised of nine items indicating the belief that parts of the body are too large. Possible scores range from 0 to 27, with higher scores indicating greater dissatisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831894|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Bulimia Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Bulimia subscale is comprised of seven items indicating the tendency towards episodes of uncontrollable overeating (binge eating). Possible scores range from 0 to 21, with higher scores indicating greater tendency. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831895|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Eating Disorders Inventory (EDI), Drive for Thinness Subscale.|The EDI is a 64 item self-report measure of psychological and behavioral characteristics of eating disorders. The Drive for Thinness subscale is comprised of seven items indicating excessive concern with dieting, preoccupation with weight and entrenchment in an extreme pursuit of thinness. Possible scores range from 0 to 21, with higher scores indicating greater Drive for Thinness. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831896|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).|The Q-LES-Q is a 93 item self-report measure of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. Each of the 93 items is scored on a five-point scale, and the total score is converted to a percentage of the maximum score possible. The range is therefore from 0 to 100, with a higher score indicating greater enjoyment or satisfaction. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||percentage of maximum possible score||Standard Error|Mean
2831897|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With the Rosenberg Self-Esteem Scale (RSES).|The RSES is a 10 item self-report measure of self-esteem. Possible scores range from 0 - 30, with lower scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831898|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Depression Inventory (BDI)|The Beck Depression Inventory-II is a 21 question self-report measure of depressive symptoms. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms.Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831899|NCT00288574|Secondary|Change Per Month in Psychological Symptoms During Treatment, Assessed With Beck Anxiety Inventory (BAI)|The Beck Anxiety Inventory is a 21 question self-report measure of anxiety symptoms during the past week. Possible scores range from 0 - 63, with higher scores indicating more severe symptoms. Random effects regression models were used to compare fluoxetine vs placebo groups over time, using data from all patients.|12 months||||units on a scale||Standard Error|Mean
2831900|NCT00288574|Secondary|Change in Weight Per Month During Treatment||12 months||||kg per month||Standard Error|Mean
2831901|NCT00288574|Primary|Proportion of Patients Remaining in Study at 1 Year|The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.|12 months||||proportion of participants|||Number
2831902|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS pain subscale scores have been included in the pain subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS pain subscale score analyses."|||points on a scale||Standard Deviation|Mean
2831903|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS disability subscale scores have been included in the disability subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS disability subscale score analyses."|||points on a scale||Standard Deviation|Mean
2831904|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS severity subscale scores have been included in the severity subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS severity subscale score analyses."|||points on a scale||Standard Deviation|Mean
2832371|NCT00283816|Secondary|Change in Weight Post Minus Pre Intervention.|Body mass index change in adolescents enrolled in lifestyle intervention program|baseline and 24 weeks||||kg/m^2||Standard Deviation|Mean
2842378|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6||||L||Standard Error|Mean
2831905|NCT00288509|Primary|Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~Subjects with incomplete TWSTRS scores were not included in the TWSTRS total score analyses."|||points on a scale||Standard Deviation|Mean
2831906|NCT00288366|Primary|HDL Ratio|change in HDL ratio after medication switch|24 weeks from Baseline||||unit of Measure ''g/dL''||Standard Error|Mean
2831907|NCT00288080|Secondary|Validity of PSA-defined Endpoints as a Surrogate for Overall Survival||From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.||2020-09-30|09/2020||||
2831908|NCT00288080|Secondary|The Time Interval Between Biochemical Failure and Distant Metastases With Respect to Testosterone Level||From date of biochemical failure to development of distant failure. Analysis occurs after all patients have been potentially followed for 4 years.||2020-09-30|09/2020||||
2831909|NCT00288080|Secondary|Incidence of Adverse Events|Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.|From start of treatment until the end of follow-up|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants|||Number
2831910|NCT00288080|Secondary|Disease-free Survival|A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2831911|NCT00288080|Secondary|Distant Metastasis|Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.|From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2831912|NCT00288080|Secondary|Local Control|Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2831913|NCT00288080|Secondary|Biochemical Control|Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.|From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2831914|NCT00288080|Primary|Overall Survival|Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2831915|NCT00288067|Primary|Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)|The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.|Up to 7 years|No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).|||participants|||Number
2831926|NCT00288015|Secondary|Objective Response Rate in Patients Treated With Bevacizumab.|"Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.~Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.||||Participants|||Count of Participants
2831916|NCT00288067|Primary|Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)|"A group of 3 patients would start treatment ast the dose of 900mg/m^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy.~Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI:~Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses >1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD."|Number of participants that experienced a dose-limiting toxicity|7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.|||participants|||Number
2831917|NCT00288054|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease (as defined per RECIST). A confirmed complete response (CR) is defined as disappearance of all disease, confirmed by a second determination of CR at least 4 weeks later. A confirmed partial response (PR) is defined as a >= 30% decrease from baseline in the sum of longest diameters, confirmed by a second determination of PR at least 4 weeks later. A patient is considered to have measurable disease if they have at least one lesion with a longest diameter of >= 2 cm by conventional CT, or >= 1 cm by spiral CT.|Week 10 and week 22|Eligible patients who began protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2831918|NCT00288054|Secondary|Progression-free Survival.|Duration from the date of enrollment until the date of progression (as defined by RECIST: >= 20% increase over baseline in the sum of longest diameters, or appearance of new lesions, or non-measurable disease that is clearly worsening in the opinion of the treating investigator, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and free of disease progression are censored at the date of last contact.|At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.|Eligible patients who began protocol treatment were included in the analysis.|||months||95% Confidence Interval|Number
2831919|NCT00288054|Secondary|Overall Survival|The duration form the date of enrollment until the date of death due to any cause. Patients last known to be alive are censored at the date of last contact.|weekly while patient is on protocol treatment, then monthly thereafter.|Eligible patients who began protocol treatment were included in the analysis.|||months||95% Confidence Interval|Median
2831920|NCT00288054|Primary|Treatment-related Esophagitis or Pneumonitis|The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.|Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.|Eligible patients who received protocol treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2831921|NCT00288054|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.|Eligible patients who received protocol treatment.|||Participants|||Number
2831922|NCT00288015|Post-Hoc|Time to Progression|"During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment , and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage) Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.~Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); ever 3-4 months after treatment up to 2 years||||Weeks||Standard Deviation|Mean
2831923|NCT00288015|Secondary|Evaluate the Toxicity of Bevacizumab.|"Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years.|Number of participants with either grade 1 (mild), 2 (moderate),3 (severe), 4 (life-threatening) adverse event related to treatment.|||participants|||Number
2831924|NCT00288015|Secondary|Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival|After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years||||Weeks||95% Confidence Interval|Median
2831925|NCT00288015|Secondary|Duration of Response.|During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.|Data for this outcome measure was not collected. By the time the results of the study were being collected, this outcome measure was no longer relevant as Recist 1.0 was in use. As a result, data for this outcome measure was not collected or analysed. Time to progression was a more relevant data point.||||||
2831963|NCT00287586|Secondary|Change From Baseline in Paragraph Recall Test (Delayed)|Cognitive Function was assessed by the Paragraph Recall Test (Delayed). In the Paragraph Recall Test, participants were read two short paragraphs and asked to recall them immediately and after a 30 minute delay, using the exact words that were read aloud. Scoring was based on the number of items correctly recalled. More items correctly recalled is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||correct items||Standard Deviation|Mean
2831927|NCT00288015|Primary|Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.|"During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage).~Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0.~Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.||||Weeks||95% Confidence Interval|Median
2831928|NCT00287989|Secondary|Time to Progression|Median number of months until disease progression|after cycle 6 of chemotherapy||||months||95% Confidence Interval|Median
2831929|NCT00287989|Primary|Overall Response Rate|Percentage of patients who experienced complete or partial response as defined by RECIST|after 6 cycles of chemotherapy||||percentage of participants||95% Confidence Interval|Number
2831930|NCT00287872|Secondary|Quality of Life||0-6 months|Analysis not done on subject population.||||||
2831931|NCT00287872|Secondary|The Time to Response||1-6 months||||months||95% Confidence Interval|Median
2831932|NCT00287872|Secondary|Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation||1-6 months|Analysis not completed as the information was not relevant since no patients went on to transplant.||||||
2831933|NCT00287872|Secondary|Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)|Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).|1-6 months||||participants|||Number
2831934|NCT00287872|Primary|Clinical Response to Treatment|Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.|1-6 months||||percentage of participants||95% Confidence Interval|Number
2831935|NCT00287729|Secondary|Worsening of IPF|"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.|||Number of Patients Who Worsened|||Number
2831936|NCT00287729|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness.|Baseline to Week 72|"A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.~Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point."|||Change in Dyspnea Score||Standard Deviation|Mean
2831937|NCT00287729|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs|The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.|||Change in Percent Predicted DLco||Standard Deviation|Mean
2831938|NCT00287729|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.|||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
2831939|NCT00287729|Secondary|Change in the Six-Minute Walk Test (6MWT) Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.|||Change in Distance Walked in Meters||Standard Deviation|Mean
2831940|NCT00287729|Secondary|Progression-free Survival|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.|||Number of Patients with Progression|||Number
2831941|NCT00287729|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.|||Patients|||Number
2831942|NCT00287729|Primary|Absolute Change in Percent Predicted Forced Vital Capacity(FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.|||Change in Percent Predicted FVC||Standard Deviation|Mean
2831943|NCT00287716|Secondary|Worsening of Idiopathic Pulmonary Fibrosis (IPF)|"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.||||Number of Patients Who Worsened|||Number
2831944|NCT00287716|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.|Baseline to Week 72||||Change in Dyspnea Score||Standard Deviation|Mean
2831945|NCT00287716|Primary|Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.|From baseline up to 72 weeks||||Change in Percent Predicted FVC||Standard Deviation|Mean
2831946|NCT00287716|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs||Baseline to Week 72||||Change in Percent Predicted DLco||Standard Deviation|Mean
2831947|NCT00287716|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72||||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
2831948|NCT00287716|Secondary|Change in Six-Minute Walk Test (6MWT)Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).|Baseline to Week 72||||Change in Distance Walked in Meters||Standard Deviation|Mean
2831949|NCT00287716|Secondary|Progression-free Survival (PFS)|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72||||Number of Patients with Progression|||Number
2831950|NCT00287716|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.|baseline up to 72 weeks||||Patients|||Number
2831951|NCT00287690|Secondary|Serum Genistein Concentrations|Measured from serum using liquid-chromatographic tandem mass spectrometric bioanalytical assays (HFL Ltd, Fordham, Cambridgeshire, UK).|Day 3 after Supro/placebo started.||||ng/ml||95% Confidence Interval|Median
2831952|NCT00287690|Primary|Coronary Blood Flow|Measurement of diameter 4mm distal to the Doppler wire tip (measured using quantitative coronary angiography) and blood flow velocity, measured using intracoronary Doppler), were made at baseline and at peak velocity change. A quantitative estimate of coronary blood flow was calculated from the Doppler flow velocity and quantitative angiographic data using the following equation: Q = 3.14(D2/4)(APV/2)(0.6) where Q is flow (ml/min), D is vessel diameter (mm) and APV is average peak velocity (cm/s). Data below are measurements taken at peak blood flow response following an infusion of acetylcholine (10-5M).|Day 3-4 after Supro/placebo started.||||ml/min||Standard Deviation|Mean
2831953|NCT00287690|Primary|Coronary Artery Diameter|Coronary angiograms were acquired digitally using a real-time digital image acquisition system (Siemens AG, Berlin and Munich, Germany) and analysed off-line using quantitative coronary angiography (MEDIS, Leiden, The Netherlands). Basal luminal diameter of the entire coronary artery (mean luminal diameter) was measured for all subjects. Mean luminal diameter and luminal diameter approximately 4 mm distal to the tip of the Doppler wire were measured. The latter measurements were used to quantify volume flow as described previously. Data below are mean coronary artery diameter response following infusion of acetylcholine (ACh 10-5 M).|Day 3-4 after Supro/placebo started.||||mm||Standard Deviation|Mean
2831991|NCT00286754|Secondary|Exercise Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.|6 months||||participants|||Number
2831954|NCT00287586|Secondary|Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)|The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. The Overall Score is the average of the individual domain scores. A negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
2831955|NCT00287586|Secondary|Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)|IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (6 questions), orgasmic function (2 questions), sexual desire (2 questions), intercourse satisfaction (3 questions), and overall sexual satisfaction (2 questions). Each question was answered on a 5-point scale from 1 to 5 (best) with a total possible score range of 0 to 75 with higher scores representing better function. A positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
2831956|NCT00287586|Secondary|Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power|Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. A negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.|||watts||Standard Deviation|Mean
2831957|NCT00287586|Secondary|Change From Baseline in Chest Press Strength and Leg Press Strength|Maximal voluntary strength of the lower and upper extremities was assessed using the one repetition maximum (1-RM) method for the seated leg press and chest press exercises. Participants were positioned with standardized seat position and foot placement that allowed 90° of knee flexion for the leg press exercise. Seat height and handle position was standardized for the chest press. Participants were familiarized with the exercises, practiced the technique and completed a 5-minute warm-up. The 1-RM procedure consisted of a warm up set with 5 to 8 repetitions at a resistance set to about 50% of the participant's estimated 1-RM and progressed with increasing loads interspersed with standardized rest periods until the participant was able to perform only one full-range-of-motion repetition.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.|||newton||Standard Deviation|Mean
2831958|NCT00287586|Secondary|Change From Baseline in the Trail Making Test B|Cognitive function was assessed by the Trail Making Test B. Trail Making Test B involved participants connecting numbers (1-13) and letters (A-L) alternately (1-A, 2-B, etc) on a piece of paper as quickly as possible. Scores represent the time it takes the participant to complete the test. Less time is best and a negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||seconds||Standard Deviation|Mean
2831959|NCT00287586|Secondary|Change From Baseline in the Stroop Interference Test|Cognitive function was assessed by the Stroop Interference Test. In the Stroop Interference Test, participants were presented with a word list of colors printed in ink of a color different from how the printed word read. Participants were instructed to read aloud the color of the ink in which a word was printed, while not verbalizing the word itself. The time in seconds that the items were correctly identified was recorded. Less time is better and a negative change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||seconds||Standard Deviation|Mean
2831960|NCT00287586|Secondary|Change From Baseline in the Category Fluency Test|Cognitive function was assessed by the Category Fluency Test. Participants were asked to name as many items from a given category as possible. Higher number of items named is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||items||Standard Deviation|Mean
2831961|NCT00287586|Secondary|Change From Baseline in the Verbal Fluency Test|Cognitive function was assessed by the Verbal Fluency Test. Participants were asked to name as many letters from a given category as possible in 1 minute. Higher number of letters is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||letters||Standard Deviation|Mean
2831962|NCT00287586|Secondary|Change From Baseline in the Buschke Selective Reminding Test (Delayed)|Cognitive function was assessed by the Buschke Selective Reminding Test. In the Buschke Selective Reminding Test, participants were read 12 words and asked to recall as many words as possible. Subsequent trials included only those words that were not recalled in the preceding trial. Individuals were also asked to recall the list 30 minutes later. To assess phonemic and category fluency, participants were asked to name as many items from a given category as possible in 1 minute. Higher number of correct items is best and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||correct items||Standard Deviation|Mean
2832372|NCT00283816|Primary|Reduction in Abdominal Fat as Measured by Waist Circumference.|Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention|baseline and 24 weeks||||cm||Standard Deviation|Mean
2842379|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6||||L||Standard Error|Mean
2831964|NCT00287586|Secondary|Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)|Cognitive Function was assessed by Complex Figure (Immediate) and (Delayed). The Complex Figure Test consists of three tasks: copy, immediate recall, and delayed recall. Participants were presented with a complex design and then asked to draw the same figure. Subsequently, they were instructed to draw what they remembered immediately, and after a 30 minute delay. Scoring was based on the number of correct items for a total possible score of 0 (worst) to 36 (Best). A positive change from Baseline indicates improvement. A negative change from Baseline indicates a worsening.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.|||correct items||Standard Deviation|Mean
2831965|NCT00287586|Secondary|Changes in Blood Pressure||Three years|No analysis was performed. Although blood pressure measurements were standardized within a trial site, there is a possibility that measurement techniques might have varied across the three trial sites over the trial’s long duration. For this reason we decided not to include blood pressure data in the results.||||||
2831966|NCT00287586|Secondary|Changes in Biomarkers of Inflammation||Three years|No analysis was performed. No funds were left to cover the costs of the assays for inflammation biomarkers.||||||
2831967|NCT00287586|Secondary|Change From Baseline in Lipid Profiles|Laboratory tests included in the lipid profile were Total Cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides.Lower values for Total Cholesterol, LDL-C are better and a negative change from Baseline indicates improvement. Higher values for HDL-C are better and a positive change from Baseline indicates improvement.|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||mg/dL||Standard Deviation|Mean
2831968|NCT00287586|Primary|Change From Baseline in Coronary Artery Calcium Score|"A multiple detector computed tomography (MDCT) scan was performed. Proximal coronary arteries were visualized, and at least 30 consecutive images were obtained at 3-mm intervals. Coronary calcium was defined as a plaque of at least 3 contiguous pixels (area, 1.02 mm^2) with a density of more than 130 Hounsfield units.The lesion score was calculated by multiplying lesion area by a density factor derived from Hounsfield units. The Agatston method was used to determine the total calcium score by summing the lesion scores from the left main, left anterior descending, circumflex, and right coronary arteries. The Agatston score is the measure of calcification in arteries expressed on continuous scale with 0 value (better) indicating no calcification and score above 400 (worse) indicating high calcification. There is no upper limit for this measure. A positive change from baseline indicates a worsening."|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
2831969|NCT00287586|Primary|Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)|B-mode carotid artery images for IMT were acquired from the far wall of the distal centimeter of the right carotid artery with high-resolution ultrasound equipment. IMT is used as a predictor of the incidence of cardiovascular events. An increase in the IMT thickness is associated with a higher incidence of cardiovascular events. Less thickening is best. Change is expressed in millimeters (mm).|Baseline and Month 36|All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.|||mm||Standard Deviation|Mean
2831970|NCT00287469|Secondary|Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases|Number of suspected, definite, probable and not confirmed hepatitis E disease cases during surveillance period|before dose 1 thru 14 days after dose 3||||Number of Hepatitis E Cases|||Number
2831971|NCT00287469|Secondary|Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period|"Percent of participants of definite hepatitis E and vaccine efficacy by category during the follow-up period~Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting~Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)~Percent of participants = n x 100 / N"|14 days after dose 2 until 14 days after dose 3||||Percent of Participants||95% Confidence Interval|Number
2831972|NCT00287469|Primary|Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period|"Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period.~Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting~Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)~Percent of Participants = n x 100 / N"|14 days after dose 3 at 6 months||||Percent of Participants||95% Confidence Interval|Number
2831973|NCT00287365|Secondary|% Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure||||percentage of FVC predicted||Standard Error|Mean
2831974|NCT00287365|Secondary|Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure||||percentage of cells||Standard Error|Mean
2831975|NCT00287365|Primary|Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects||6 hours post exposure|Mild asthmatics exposed to ozone|||percentage of FEV1 predicted||Standard Error|Mean
2831976|NCT00287339|Primary|Change in Cough-Specific Quality of Life Questionnaire|"It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, I cannot sleep at night and I cough and it makes me retch. The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is strongly disagree, and 4 is strongly agree. The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment."|baseline and 12 weeks||||participants||Standard Deviation|Mean
2831977|NCT00287222|Primary|Number of Participants Who Remained Free of Progression at the 27th Week.||27 weeks|Per protocol|||participants|||Number
2832540|NCT00282347|Secondary|Change From Baseline in Anti-double-stranded DNA at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||IU/mL||Standard Deviation|Mean
2831978|NCT00287118|Primary|"Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of Excellent or Cleared at Week 24"|The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.|Week 24|The Intent to Treat (ITT) population consisted of all subjects who received at least 1 dose of trial medication.|||percentage of subjects||95% Confidence Interval|Number
2831979|NCT00287079|Primary|Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates|CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Two participants had negative time from stabilization and CDMS relapse and were excluded from the Kaplan-Meier analysis.|||Month||Standard Error|Mean
2831980|NCT00287079|Secondary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Up to Week 96|"Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Adverse events were not captured for No Treatment group."|||percentage of participants|||Number
2831981|NCT00287079|Secondary|Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)|CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population.|||Percentage of participants|||Number
2831982|NCT00287053|Secondary|Association of Change With a Behavioral Phenotype.||February 2006 to September 2006|||||||
2831983|NCT00287053|Secondary|Endocrine Response.||February 2006 to September 2006|||||||
2831984|NCT00287053|Secondary|Change in Body Weight.||February 2006 to September 2006|||||||
2831985|NCT00287053|Secondary|Change in Posture Allocation and Energy Expenditure.||February 2006 to September 2006|||||||
2831986|NCT00287053|Primary|Change in Food Intake.|Change in food intake from baseline to week 3.|February 2006 to September 2006||||kcal||Standard Error|Least Squares Mean
2831987|NCT00286949|Primary|Frontal Systems Behavioral Scale (FrSBe) Executive Function Subscore|Frontal Systems Behavioral Scale (FrSBe) Executive Function subscore is on of the 3 subscales of the FrSBE, a scale designed to identify and quantify behavioral problems associated with frontal lobe dysfunction. The other subscales are Apathy and Disinhibition. Each item is rated on a 5-point Likert scale. Totals are generated for each subscale and normative data is referenced (based on patient gender, age and education) and standardized T-scores are determined). For all FrSBe scales, T scores ≥ 65 are considered clinically significant and scores of 60 to 64 represent likely borderline impairment.|8 weeks||||T-score||Standard Deviation|Mean
2831988|NCT00286949|Primary|Connors Adult Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-Long Form (CAARS-L) Inattention/Memory Subscale|The CAARS-L Inattention/Memory subscale, a primary self-rated outcome measure in this study, measures the frequency of behaviors associated with executive dysfunction, such as task incompletion, disorganization, distractibility, and difficulty planning, multi-tasking, and initiating tasks. CAARS-L scores are depicted as group Mean (SD) T scores, derived from comparison to CAARS norms based on gender and age in a normative sample. Similar to the FrSBE, higher T-scores are associated with greater symptom severity and T-scores above 65 represent symptoms of clinical significance.|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2831989|NCT00286949|Primary|Clinical Global Impression of Change-Clinician Rated Score (CGIC-C)|"CGIC-C score is a clinician's rating of change (improvement or worsening) over the course of the trial in an individual's symptoms and their global impact on function and clinical status, i.e., the global impact of the intervention that the patient is better, unchanged, or worse). Scale ranges1 to 7 which equates to from very much worse to very much improved.~The CGIC-C score is not an appropriate baseline measure since it represents change after initiating an intervention. In addition, a baseline Clinical Global Impression of Severity-Clinician Rated Score (CGIS-C) is not appropriate to compare to CGIC-C, as a patient with severe disease might show clinically meaningful improvement (i.e., very much improved) from an intervention while still being severely affected on the CGIS-C score; by contrast, a patient with mild CGIS-C could have minimal or no change on the CGIC-C score. This study was not designed to assess the influence of disease severity on the primary outcome (CGIC-C)."|8 weeks||||Participants|||Count of Participants
2831990|NCT00286754|Secondary|Medication Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.|6 months||||participants|||Number
2831992|NCT00286754|Secondary|Diet Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.|6 months||||participants|||Number
2832005|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832006|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832007|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||kg||Standard Error|Least Squares Mean
2832008|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832009|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832010|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832011|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832012|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832013|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832014|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832015|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832016|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832017|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832018|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832019|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832020|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
2842380|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1||||L||Standard Error|Mean
2832021|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832022|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832023|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832024|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832025|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832026|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ratio||Standard Error|Least Squares Mean
2832027|NCT00286494|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mcIU/mL||Standard Error|Least Squares Mean
2832028|NCT00286494|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832029|NCT00286494|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832030|NCT00286494|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832031|NCT00286494|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832032|NCT00286494|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mcIU/mL||Standard Error|Least Squares Mean
2832033|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832034|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832063|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832035|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832036|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832037|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pmol/L||Standard Error|Least Squares Mean
2832038|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pmol/L||Standard Error|Least Squares Mean
2832039|NCT00286494|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.|||participants|||Number
2832040|NCT00286494|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.|||participants|||Number
2832041|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832042|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832043|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832044|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832045|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832046|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mg/dL||Standard Error|Least Squares Mean
2832047|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832048|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832064|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832049|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832050|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832051|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832052|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832053|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832054|NCT00286494|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832055|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832056|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832057|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832058|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832059|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832060|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832061|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832062|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832065|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832066|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832067|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832068|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832069|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832070|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
2832071|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
2832072|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832073|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832074|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832075|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832076|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||ratio||Standard Error|Least Squares Mean
2832077|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||ratio||Standard Error|Least Squares Mean
2832078|NCT00286468|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832302|NCT00285012|Secondary|Number of Subjects With 4-Week Point Prevalence of Abstinence|Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All subjects population|||particpants|||Number
2832079|NCT00286468|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832080|NCT00286468|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832081|NCT00286468|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832082|NCT00286468|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mcIU/mL||Standard Error|Least Squares Mean
2832083|NCT00286468|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mcIU/mL||Standard Error|Least Squares Mean
2832084|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832085|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832086|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832087|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832088|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||pmol/L||Standard Error|Least Squares Mean
2832089|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||pmol/L||Standard Error|Least Squares Mean
2832090|NCT00286468|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832091|NCT00286468|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.|||participants|||Number
2832092|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832093|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2834062|NCT00266032|Secondary|Number of Days With Bleeding Excluding Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.|up to 1 year|FAS|||Days||Standard Deviation|Mean
2832094|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832095|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832096|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832097|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832098|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832099|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832100|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832101|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832102|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832103|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832104|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at week 4 due to unavailable prior value to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832105|NCT00286468|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832106|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 26).|The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
2834112|NCT00265616|Secondary|Patients With Infectious Complications Requiring Specific Treatment||10 days||||participants|||Number
2832107|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 20).|The change between the value of glucagon collected at week 20 and glucagon collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
2832108|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 16).|The change between the value of glucagon collected at week 16 and glucagon collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
2832109|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 12).|The change between the value of glucagon collected at week 12 and glucagon collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pg/mL||Standard Deviation|Mean
2832110|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 8).|The change between the value of glucagon collected at week 8 and glucagon collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).) Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pg/mL||Standard Deviation|Mean
2832111|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 4).|The change between the value of glucagon collected at week 4 and glucagon collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pg/mL||Standard Deviation|Mean
2832112|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832113|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832114|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832115|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoint due to unavailable prior values to carry forward"|||kg||Standard Error|Least Squares Mean
2832116|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832117|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832118|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832119|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832120|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832121|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832122|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2842381|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1||||L||Standard Error|Mean
2832123|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832124|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832125|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832126|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832127|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
2832128|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ng/mL||Standard Error|Least Squares Mean
2832129|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832130|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832131|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832132|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832133|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ratio||Standard Error|Least Squares Mean
2832134|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||ratio||Standard Error|Least Squares Mean
2832135|NCT00286455|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
2832136|NCT00286455|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
2832402|NCT00283504|Secondary|Number Participants for Whom Sputum Induction Was Safe|safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved|every 4 weeks up to 32 weeks||||Participants|||Count of Participants
2832137|NCT00286455|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
2832138|NCT00286455|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||ϻIU/mL||Standard Error|Least Squares Mean
2832139|NCT00286455|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ϻIU/mL||Standard Error|Least Squares Mean
2832140|NCT00286455|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||ϻIU/mL||Standard Error|Least Squares Mean
2832141|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832142|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832143|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832144|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832145|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||pmol/L||Standard Error|Least Squares Mean
2832146|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||pmol/L||Standard Error|Least Squares Mean
2832147|NCT00286455|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).|||participants|||Number
2832148|NCT00286455|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and had at least 1 post-baseline FPG measurement.|||participants|||Number
2832149|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832150|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832151|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2834113|NCT00265616|Secondary|Clinical Outcome at Day 21|Return to baseline clinical conditions (i.e.: no new handicap, no death)|21 days||||participants|||Number
2832152|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832153|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832154|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"|||mg/dL||Standard Error|Least Squares Mean
2832155|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832156|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||mg/dL||Standard Error|Least Squares Mean
2832157|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832158|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832159|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832160|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832161|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832162|NCT00286455|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the week 26 visit. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832163|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832164|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832165|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832166|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832167|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832168|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832169|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832170|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832171|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832172|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832173|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).|||participants|||Number
2832174|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832175|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832176|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832177|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832178|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832179|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832180|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2840007|NCT00180713|Secondary|Circulating Levels of BNP|Change in NT-proBNP levels compared to baseline|6 months||||fmol/ml||Standard Deviation|Mean
2832181|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832182|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832183|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832184|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF.|||ratio||Standard Error|Least Squares Mean
2832185|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
2832186|NCT00286442|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832187|NCT00286442|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832188|NCT00286442|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832189|NCT00286442|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832190|NCT00286442|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832191|NCT00286442|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an insulin measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||mcIU/mL||Standard Error|Least Squares Mean
2832192|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a PROINSULIN measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832193|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832194|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832195|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832196|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832197|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||pmol/L||Standard Error|Least Squares Mean
2832198|NCT00286442|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.|||participants|||Number
2832199|NCT00286442|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.|||participants|||Number
2832200|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832201|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832202|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832203|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832204|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832205|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2. Missing data imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832206|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2.|||mg/dL||Standard Error|Least Squares Mean
2832207|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 1.|||mg/dL||Standard Error|Least Squares Mean
2832208|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 20.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832209|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 16.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832210|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 12.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832211|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 8.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832212|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832213|NCT00286442|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 26.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832214|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832215|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832216|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832217|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
2832218|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.~Due to no participants in the placebo arm achieved HbA1c decrease from baseline ≥2.0%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."|||participants|||Number
2832219|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
2832220|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
2832221|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
2832222|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
2832223|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.|||participants|||Number
2832224|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 HbA1c measurement after baseline.~Due to no participants in the placebo arm achieved HbA1c ≤ 6.5%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."|||participants|||Number
2840008|NCT00180713|Secondary|Change in LV Mass|Change in LV mass from baseline based on cardiac MRI|6 months||||grams||Standard Deviation|Mean
2832225|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832226|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832227|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832228|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832229|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832230|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||ng/mL||Standard Error|Least Squares Mean
2832231|NCT00286429|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.|||participants|||Number
2832232|NCT00286429|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.|||participants|||Number
2832233|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832234|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832235|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832236|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832237|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832238|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832239|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 2. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832240|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 1. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
2832241|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832242|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832243|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832244|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832245|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832246|NCT00286429|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF). ANCOVA = Analysis of covariance.|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2832247|NCT00286325|Secondary|B Cell Number at Week 24|Peripheral blood B cell number at week 24 compared to B cell number at week 0|Week 0 and at 24 weeks|excluded subject with epidermolysis bullosa acquisita diagnosed after study entry|||B cells per microliter||Full Range|Median
2832248|NCT00286325|Secondary|IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24.|IgG antibodies against BP 180 measured in units (by ELISA) for each participant at week 0 compared to value at week 24,|Week 0 and at 24 weeks|Excluded subject with diagnosis of epidermolysis bullosa acquisita made after study entry, excluded one subject with no circulating antibodies measured at either time point.|||Elisa Units||Full Range|Median
2832249|NCT00286325|Secondary|Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24|Subject systemic corticosteroid dosage at week 24 was 25% of starting dose or 10 mg/day of prednisone or less|24 weeks|Excluded subject with epidermolysis bullosa acquisita diagnosed after study entry.|||participants|||Number
2832250|NCT00286325|Primary|Primary Safety Endpoint|The primary safety endpoint is the occurrence of treatment emergent adverse events including infections, infusion reactions and disease progression. These were determined by clinical evaluation and laboratory questions. Disease progression is defined as development of new blisters despite therapy. These are reported as the number of participants with a study related SAE.|1 year|The safety analysis was performed on all subjects|||participants|||Number
2832251|NCT00286325|Secondary|Number of Days to Cessation of New Blister|The first study visit in which patient reported and was confirmed to have no new blister or lesion formation .|1 year|Excluded subject with diagnosis of epidermolysis bullosa acquisita , made after study entry.|||Days||Full Range|Median
2832252|NCT00286221|Secondary|Fentanyl Consumption|the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.|Up to 16 hours||||mcg/hour||Standard Deviation|Mean
2832253|NCT00286221|Primary|Hourly Pain Scores|Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)|Up to 16 hours||||units on a scale||Standard Deviation|Mean
2832254|NCT00286182|Primary|Change in Left Ventricular End-diastolic Volume|This outcome measure is collected using a three dimensional echocardiography.|Baseline and 6 month||||mL||Standard Error|Mean
2832255|NCT00286156|Secondary|Change in Total Kidney Volume as Measured by 3D-CT From Baseline to 12 Months|Total kidney volume measured by CT from baseline to 12 months|From baseline to 12 months||||ml||Standard Deviation|Mean
2832256|NCT00286156|Primary|Change in GFR From Baseline to 12 Months|GFR (glomerular filtration rate) was measured by iothalamate. GFR is a key indicator of renal function.|From baseline to 12 months||||ml/min/1.73m^2||Standard Deviation|Mean
2832403|NCT00283504|Secondary|Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control||32 weeks||||Participants|||Count of Participants
2847536|NCT00100698|Secondary|Change in Extremity Fat|Change in extremity fat|18 months||||kilograms||Standard Error|Mean
2832257|NCT00286091|Secondary|Overall Survival|Time from randomization to the date of death. Participants who were still alive or lost to follow-up by the primary analysis data cut-off date were censored at their last contact date (on-study or during survival follow-up) or the primary analysis data cut-off date, whichever was first.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set|||days||95% Confidence Interval|Median
2832258|NCT00286091|Secondary|Time to First Bone Metastasis|Time from randomization to the date of first occurrence of bone metastasis (either symptomatic or asymptomatic), excluding death. Participants who did not develop bone metastasis were censored at their last on-study bone assessment date or the primary analysis data cut-off date, whichever was first. Median time to first bone metastasis was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set|||days||95% Confidence Interval|Median
2832259|NCT00286091|Primary|Bone Metastasis-free Survival|The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set (all randomized participants)|||days||95% Confidence Interval|Median
2832260|NCT00286078|Primary|Frequency of Adverse Event|Cumulative frequency of adverse events from randomization to 26 weeks|26 weeks||||events|||Number
2832261|NCT00286078|Primary|Migraine Frequency at 12 Weeks|Change from baseline in migraine days/month at 12 weeks|Baseline and 12 weeks|Modified Intent to Treat|||days||Standard Deviation|Mean
2832262|NCT00285857|Secondary|Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day||6 months|Change in mean of LDL level, with standard deviation of the values at|||mg/dL||Standard Deviation|Mean
2832263|NCT00285857|Secondary|Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day||6 months||||mg/dL||Standard Deviation|Mean
2832264|NCT00285857|Secondary|Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day|"Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment.~Category 0 Need additional imaging evaluation~Negative~Benign~Probably benign~Suspicious abnormality~Highly suggestive of malignancy~Known biopsy-proven malignancy"|6 months|Outcome reported as the change in mean mammographic density with standard deviation (SD) of the post-treatment measurements.|||BI-RADS||Standard Deviation|Mean
2832265|NCT00285857|Primary|Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day|"Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day.~Cytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows:~06-10 Non-proliferative breast disease (NPBD)~11-14 Proliferative breast disease without atypia (PBD-A)~15-18 Proliferative breast disease with atypia (PBD+A)~19-24 Carcinoma in situ and invasive cancer (CIS/IC)~If no cells could be obtained after multiple RPFNA attempts, the classification was acellular.~Change from NPBD to PBD-A was considered Unfavorable.~Change from NPBD to Acellular was considered Equivocal.~Change from PBD-A to NPBD was considered Favorable."|6 months|"Participants either at least one of the following:~Deleterious germline mutation in BRCA1, BRCA2, CDH1, or TP53~Lifetime breast cancer risk of breast cancer of 20 % as estimated by the Claus model~Personal history of estrogen receptor andprogesterone receptor-negative breast cancer."|||participants|||Number
2832266|NCT00285818|Primary|Hamilton Depression Rating Scale Score|The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups.|Screening to Final Visit||||units on a scale||Standard Deviation|Mean
2832267|NCT00285779|Secondary|The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24||24 weeks|Data were not collected for this outcome measure||||||
2832268|NCT00285779|Secondary|"The Count of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of Clear) at 12 Weeks"|"A complete response is defined as a score of 0 (representing no disease) on the Physician Global Assessment. Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. This endpoint is the number of patients on placebo that had any score other than 0 on this measure."|12 weeks|Only participants in the Placebo injection group were evaluated for this outcome measure.|||Participants|||Count of Participants
2832269|NCT00285779|Secondary|The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24|A serious adverse event was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Baseline; Week 12; Week 24||||Participants|||Count of Participants
2832270|NCT00285779|Secondary|Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks|Participants were asked to indicate their rate their overall assessment of disease severity compared to where it was at their baseline visit. The scale ranges from 0-5, with lower scores correspond to more disease improvement. 0=clear/no disease, 1=much improved (>75% improved), 2=improved (25-75%), 3=minimally improved (<25%), 4=no change, 5=worsened disease.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2832404|NCT00283504|Primary|Number of Participants With Change in Sputum Markers by End of Study|sputum markers were classified as eosinophilic or non eosinophilic|32 weeks||||Participants|||Count of Participants
2840206|NCT00176891|Primary|Number of Patients Requiring Ventilator Support at One Year Post Transplant||one year||||Participants|||Count of Participants
2832271|NCT00285779|Secondary|Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks|Participants were asked to indicate their itching level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less itching, higher scores correspond to more itching.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2832272|NCT00285779|Secondary|Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks|Participants were asked to indicate their pain level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less pain, higher scores correspond to more pain.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2832273|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks|This score sums all of the 3 elements of the target lesion score (erythema, elevation, scale) described in Outcome Measures 6-8. Assessment scores range from 0-9 on a Likert scale, with higher numbers meaning more severe disease in the target skin lesion.|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2832274|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks|This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse scaling. 0=none, 1=fine/dusty scale, 2=moderate scale, 3=thick/tenacious scale.|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2832275|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks|This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse elevation. 0=flat, 1=barely palpable (<0.5 mm), 2=moderate (0.5 mm-1 mm), 3=severe (>1 mm).|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2832276|NCT00285779|Secondary|Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks|This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse erythema. 0=clear, 1=mild/pink, 2=moderately red, 3=severely red/violaceous.|Week 12; Week 24|Participants with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2832277|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks|The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2832278|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks|The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2832279|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks|The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.|Baseline; Week 12; Week 24|Participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2832280|NCT00285779|Secondary|Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks|Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.|Baseline; Week 24||||Participants|||Count of Participants
2832281|NCT00285779|Primary|The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks|Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.|12 weeks|Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
2832282|NCT00285649|Primary|Roland Morris Low Back Pain Disability Questionnaire (RMDQ)|The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.|Mean change from baseline to week 3||||units on a scale||Standard Deviation|Mean
2832283|NCT00285584|Secondary|Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.|The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment|Month 6 compared to enrollment (Month 0)||||units on a scale||Full Range|Median
2832284|NCT00285584|Secondary|Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)|Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.|Enrollment to Month 6|Self-reported and laboratory identified sexually transmitted infections|||participants|||Number
2832303|NCT00285012|Secondary|Number of Subjects With 7-Day Point Prevalence of Abstinence|Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.|Week 12, Week 24, Week 52|All subjects population|||participants|||Number
2832285|NCT00285584|Secondary|Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.|Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.|Month 6 compared to Month 0 (enrollment)|All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6|||Drug-using occasions per month||Full Range|Median
2832286|NCT00285584|Primary|The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.|The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.|Enrollment to Month 6|Subjects remaining in study through 6-Month study visit.|||Sexual partners||Full Range|Median
2832287|NCT00285467|Secondary|Systolic Blood Pressure at 3 Months|systolic blood pressure at 3 months|3 month||||mmHg||Standard Deviation|Mean
2832288|NCT00285467|Primary|Percent Reduction in PTH|Percent reduction in PTH from baseline to 3 months|3 month|The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.|||% change in PTH baseline to 3 months||Standard Deviation|Mean
2832289|NCT00285246|Primary|Health Care Utilization|This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on the healthcare utilization measure.|||number of visits in prior 12 months||Standard Deviation|Mean
2832290|NCT00285246|Primary|Mental Functional Status|Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.|pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return|Not all of the 790 completers has complete data on the mental functional status measure.|||units on a scale||Standard Deviation|Mean
2832291|NCT00285246|Primary|Physical Functional Status|Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on this physical functional status measure.|||Units on a scale||Standard Deviation|Mean
2832292|NCT00285246|Primary|Non-Specific Physical Symptoms|Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.|pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)|Not all of the 790 completers has complete data on the non-specific physical symptoms measure.|||units on a scale||Standard Deviation|Mean
2832293|NCT00285207|Secondary|Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.||over the course of the trial|||||||
2832294|NCT00285207|Secondary|Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection.||over the course of the trial|||||||
2832295|NCT00285207|Secondary|Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.||over the course of the trial|||||||
2832296|NCT00285207|Primary|Pathological Response|Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.|baseline and 4 months||||participants|||Number
2832297|NCT00285012|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).|Baseline, Week 52|Subjects with change in body weight in the All subjects population|||kg||Standard Deviation|Mean
2832298|NCT00285012|Secondary|Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen|Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).|Baseline, Week 12, Week 52|All subjects population; (n) = number of subjects with analyzable data at observation for varenicline and placebo, respectively.|||mg/dl||Standard Deviation|Mean
2832299|NCT00285012|Secondary|Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period|Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.|Day 1 through Day 21|All subjects population; (n) = number of subjects who smoked at least 1 cigarette at the given day for varenicline and placebo, respectively.|||cigarettes per day||Standard Deviation|Mean
2832300|NCT00285012|Secondary|Change From Baseline in Clinical COPD Questionnaire (CCQ)|Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.|Baseline, Week, 12, Week 24, Week 52|All subjects; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832301|NCT00285012|Secondary|Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.|Baseline, Week 12, Week 52|All subjects population; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively. Missing data imputed by carrying the last observation forward (LOCF), including baseline values.|||ml||Standard Deviation|Mean
2832305|NCT00285012|Secondary|Number of Subjects With Continuous Abstinence (CA)|Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.|Week 9 through Week 24 and Week 52|All subjects population|||participants|||Number
2832306|NCT00285012|Primary|Number of Subjects With Four Week Continuous Quit Rate (CQR)|Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory [NUI]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).|Week 9 through Week 12|All subjects population: received at least 1 dose, including partial doses, of randomized study drug.|||participants|||Number
2832307|NCT00284934|Secondary|Number of Participants With Graft and Patient Survivals at 6 Months|Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||Participants|||Number
2832308|NCT00284934|Secondary|Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months|A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||Participants|||Number
2832309|NCT00284934|Secondary|Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)|Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and 3 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||mL/min/1.73m^2||Standard Deviation|Mean
2832310|NCT00284934|Primary|Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)|Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and Month 6|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.|||mL/min/1.73m^2||Standard Deviation|Mean
2832311|NCT00284856|Secondary|Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period|PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.|||Liters/minute||Standard Deviation|Mean
2832312|NCT00284856|Secondary|Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period|4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.|||Score on a scale||Standard Deviation|Mean
2832313|NCT00284856|Primary|Percentage of Asthma-control Days Over the 6-month Treatment Period|An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.|6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication.|||Percentage of days||Standard Deviation|Mean
2832314|NCT00284739|Secondary|Duration (in Days) of Percutaneous Drainage.|The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.|Up to 30 days||||days||95% Confidence Interval|Mean
2840207|NCT00176891|Primary|Number of Patients Alive at One Year Post Transplant||one year||||Participants|||Count of Participants
2832315|NCT00284739|Secondary|Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement|This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.|3 days||||percentage of patients|||Number
2832316|NCT00284739|Primary|Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage||30 days||||participants|||Number
2832317|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 12-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|12-months post-intervention||||Z-score||Standard Deviation|Mean
2832318|NCT00284557|Secondary|"Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and Screen Time"||6- and 12-months post-intervention|||||||
2832319|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 6-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|6-months post-intervention||||Z-score||Standard Deviation|Mean
2832320|NCT00284518|Post-Hoc|Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers|The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2832321|NCT00284518|Other Pre-specified|Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain|The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||Score on a scale||Standard Deviation|Mean
2832322|NCT00284518|Secondary|Change From Baseline in Post-Void Residual|Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.|Baseline, Week 2, Week 12, Week 72|Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.|||milliliters (mL)||Standard Deviation|Mean
2832323|NCT00284518|Secondary|Change From Baseline in Transitional Zone Prostate Volume|Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||milliliters (mL)||Standard Deviation|Mean
2832324|NCT00284518|Secondary|Change From Baseline in Total Prostate Volume|Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||milliliter (mL)||Standard Deviation|Mean
2832325|NCT00284518|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||milliliters (mL)/second||Standard Deviation|Mean
2832326|NCT00284518|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||Score on a scale||Standard Deviation|Mean
2832327|NCT00284518|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.|||Score on a scale||Standard Deviation|Mean
2832328|NCT00284180|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||percentage of participants||95% Confidence Interval|Number
2834149|NCT00265330|Primary|Mean Change From Baseline for Body Weight|Mean change; body weight value at observation minus body weight value at baseline.|Week 6, Week 26||||kilogram||Standard Deviation|Mean
2832329|NCT00284154|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|All patients were assessed for progression free survival.|||Months||95% Confidence Interval|Median
2832330|NCT00284154|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.|||Months||95% Confidence Interval|Median
2832331|NCT00284154|Secondary|Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|All patients were assessed for response. Only patients with objective response were analyzed for response duration.|||Months||95% Confidence Interval|Median
2832332|NCT00284154|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.|18 months|All patients were assessed for response.|||percentage of participants||95% Confidence Interval|Number
2832333|NCT00284141|Secondary|Number of Participants With Anti-drug Antibodies|"Anti-drug antibodies in a participant's serum sample were assayed with an anti-drug ELISA assay, with a lower limit of quantitation of 238.4 ng/mL for an undiluted human serum sample.~Serum for anti-drug antibody analysis was collected pre-dose on every fourth cycle after Cycle 1 Day 1 (at 8 week intervals), at end of treatment (EOT), and during post-treatment follow-up 60 days after the last dose."|up to 2.5 years after initial treatment|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.|||participants|||Number
2832334|NCT00284141|Primary|Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator.|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).~Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.|||participants|||Number
2832335|NCT00284141|Secondary|Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap)|"Median free and VEGF-bound trough concentrations were determined at the end of each cycle beyond Cycle 2 (Steady-state) for each participant.~Plasma free aflibercept levels were estimated by a validated direct ELISA, with an LOQ of 15.6 ng/mL. Plasma VEGF-bound aflibercept levels were also estimated by a separate validated direct ELISA with an LOQ of 43.9 ng/mL.~Mean ± SD (coefficient of variation [CV%]) values were estimated from the median values calculated for each participant."|At the end of each treatment cycle (up to 2.5 years)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples on Day 1 of Cycle 3 for measurement of VEGF-bound aflibercept.|||micrograms/mL||Standard Deviation|Mean
2832336|NCT00284141|Secondary|Peak of Free Aflibercept (VEGF Trap)|Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL.|Day 1 of the first infusion of Aflibercept (cycle 1)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.|||micrograms/mL||Standard Deviation|Mean
2832337|NCT00284141|Secondary|Number of Participants With Laboratory Abnormalities|"Participants with abnormal laboratory results for~Liver and renal function (Alkaline phosphatase, Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Creatinine, Hyperbilirubinemia),~Electrolytes (Hypercalcemia, Hypocalcemia, Hypokalemia, Hypernatremia, Hyponatremia, Hypophosphatemia)~Metabolism (Hypoalbuminemia, Hyperglycemia, Hypoglycemia)~Hematology (Partial thromboplastin time, Anemia, Lymphopenia, Neutropenia, Thrombocytopenia, Leukopenia)"|Up to 2.5 years|All participants who received at least part of 1 dose of study treatment.|||Participants|||Number
2832338|NCT00284141|Secondary|Overall Safety - Number of Participants With Adverse Events|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008)|All participants who received at least part of 1 dose of study treatment.|||participants|||Number
2832339|NCT00284141|Secondary|Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale|"HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms.~The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL."|Baseline to 2.5 years|All registered participants with available questionnaires at the timepoint assessed.|||score on a scale||Standard Deviation|Mean
2832587|NCT00282256|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||participants|||Number
2832340|NCT00284141|Secondary|Overall Survival (OS)|"OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots.~A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier."|up to 2.5 years from initial treatment|All registered participants. 38 participants were censored for OS.|||months|Participants|95% Confidence Interval|Median
2832341|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Investigator|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors."|up to 2.5 years from initial treatment|All registered participants. 17 participants were censored.|||weeks|Participants|95% Confidence Interval|Median
2832342|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC)|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.~If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier."|up to 2.5 years from initial treatment|All registered participants. 18 participants were censored.|||weeks|Participants|95% Confidence Interval|Median
2832343|NCT00284141|Secondary|Duration of Response (DR)|DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR.|up to 2.5 years from initial treatment|No modified RECIST responses, as confirmed by the IRC review, were observed. Only 2 responders were reported by the Investigators. Therefore, the analyses for duration of response was not performed.||||||
2832344|NCT00284141|Primary|Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC).|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).~Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.|||Participants|||Number
2832345|NCT00284089|Secondary|Mean Change From Baseline in Total Retinal Volume of the Study Eye in Group B|Total retinal volume was assessed by Optical Coherence tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|OCT was performed in a total of 58 patients at selected sites. Group B Intent-to treat (ITT) population, observed data only are included. The assessed sample size was small for total retinal volume data because the central reading center judged “Can not grade” due to retinal pigment epithelium disruption associated with CNV secondary to AMD.|||micrometers||Standard Deviation|Mean
2832346|NCT00284089|Secondary|Mean Change From Baseline in Foveal Retinal Thickness of the Study Eye in Group B|Foveal retinal thickness was assessed by Optical Coherence Tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|The analysis includes Group B Intent-to treat (ITT) population, observed data. OCT was performed in a total of 58 patients at selected sites.|||micrometers||Standard Deviation|Mean
2832347|NCT00284089|Secondary|Percentage of Participants in Group B With Absence of Leakage in the Study Eye at Month 3, 6, 9 and 12.|Area of leakage was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed at the central reading center.|Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and for whom data was available. The Last Observation Carried Forward (LOCF) was used to impute missing data.|||Percentage of participants|||Number
2832348|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Leakage From CNV Plus Staining of Retinal Pigment Epithelium of the Study Eye in Group B|Area of leakage from CNV plus staining of retinal pigment epithelium was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The total area is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.|||disc areas||Standard Deviation|Mean
2832349|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Choroidal Neovascularization of the Study Eye in Group B|Choroidal Neovascularization was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The area of Choroidal Neovascularization is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.|||disc areas||Standard Deviation|Mean
2832405|NCT00283439|Secondary|Percentage of Subjects That Received Platelet Transfusions|Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||Percentage of participants|||Number
2832350|NCT00284089|Secondary|Extension Phase: Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Last Visit of Extension Phase in Group B|"BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The following categories were evaluated:~Participants with a BCVA score loss of fewer than 15 letters from baseline at Last Visit~Participants with a BCVA score loss of 30 or more letters from baseline at Last Visit~Participants with a BCVA score gain of 15 or more letters from baseline at Last Visit~Participants with a BCVA score of less than 34 letters at Last Visit"|Baseline and last visit of extension phase - Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|Includes patients enrolled in the extension phase, observed data.|||Participants|||Number
2832351|NCT00284089|Secondary|Extension Phase: Mean Change From Month 12 (Start of Extension Phase) in Best Corrected Visual Acuity Score of the Study Eye at Last Visit of Extension Phase in Group B.|Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Month 12 (start of extension phase) and last visit of extension phase. Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|The analysis population included all enrolled patients in the extension phase. For the analysis of the results of the extension phase, all data are presented as observed. Patients must have values both at Month 12 and Last Visit to be included.|||Letters||Standard Deviation|Mean
2832352|NCT00284089|Secondary|Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Month 6 and Month 12 in Group B|BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters.|Baseline, Month 6 and Month 12|ITT population, using LOCF.|||Participants|||Number
2832353|NCT00284089|Secondary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 12 in Group B|The efficacy assessment was based on Group B patients. BCVA was assessed during all study visits using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the efficacy variable. The Last Observation carried Forward (LOCF) was used to impute missing data at month 12 in the ITT analysis.|||Number of Letters||Standard Deviation|Mean
2832354|NCT00284089|Primary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B|The efficacy assessment was based on Group B patients. Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 6|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. The Last Observation Carried Forward (LOCF) was used to impute missing data at month 6 in the ITT analysis.|||Number of Letters||Standard Deviation|Mean
2832355|NCT00284050|Secondary|Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.|||µm||Standard Deviation|Mean
2832356|NCT00284050|Primary|Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.|||Letters||Standard Deviation|Mean
2832357|NCT00284050|Primary|Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.|||Letters||Standard Deviation|Mean
2832358|NCT00283959|Secondary|α-Galactosidase A (α-Gal A) Activity In Peripheral Blood Mononuclear Cells (PBMC) At Baseline, Week 12, And Week 48|"PBMCs were isolated from whole blood and lysed, and α-Gal A activity was measured by a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hour [hr]) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat.~α-Gal A activity in PBMCs are presented by individual participants. Values of 0 presented below represent α-Gal A activity levels that were below the lower limit of quantification."|Baseline, Week 12 (end of treatment period), Week 48 (end of extension period)|PD Population: All participants who received at least 1 dose of study drug and had at least 1 non-missing postbaseline PD parameter recorded. Participants who discontinued prior to the specified time point were not analyzed because no data were available.|||nmol 4-MU/hr/mg protein|||Number
2832359|NCT00283959|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|"TEAEs were defined as any adverse event with a start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented.~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Day 1 (after dosing) through Week 48 (end of extension period)|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2832360|NCT00283933|Secondary|α-Galactosidase A (α-Gal A) Activity In Peripheral Blood Mononuclear Cells (PBMC) At Baseline, Week 24, And Week 48|PBMC were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hour [hr]) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.|Baseline, Week 24 (end of treatment period), Week 48 (end of extension period)|PD Population: All participants who received at least 1 dose of study drug and had at least 1 non-missing postbaseline PD parameter recorded.|||nmol 4-MU/hr/mg protein|||Number
2832361|NCT00283933|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 48 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Week 48|Safety Population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2832362|NCT00283868|Secondary|Percentage of Evaluations With Technical Observations|Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.|Time of consultation||||Percentage of Evaluations|||Number
2832363|NCT00283868|Secondary|Time to Treatment Decision for Administration of Thrombolytics|time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.|potentially within 3 hours of symptom onset||||Minutes||Standard Deviation|Mean
2832364|NCT00283868|Secondary|Percentage of Total Thrombolytic Administrations|This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.|potentially within 3 hours of symptom onset||||Percentage of participants|||Number
2832365|NCT00283868|Secondary|Percentage of Participants With Intracerebral Hemorrhage (ICH)|Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.|36 hours||||Percentage of participants|||Number
2832366|NCT00283868|Primary|Appropriateness of Decision to Treat or Not Treat With Thrombolytics|"This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.~Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was appropriate to give or not give rt-PA."|potentially within 3 hours of symptom onset|Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone.|||percentage of participants|||Number
2832367|NCT00283842|Secondary|Number of Patients With ≥50% Reduction in Mean Pain Severity Score.|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.|Baseline and 13 weeks|The analysis population is the intent to treat.|||patients|||Number
2832368|NCT00283842|Primary|Change in Mean Pain Severity Score From Baseline to 13 Weeks|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.|Baseline and 13 weeks|The analysis population was the intent to treat.|||units on scale||Standard Error|Mean
2832369|NCT00283816|Secondary|Change in Sex Hormone Binding Globulin (SHBG)|SHBG concentration post minus pre-intervention|baseline and 24 weeks||||nmol/L||Standard Deviation|Mean
2832370|NCT00283816|Secondary|Total Testosterone Change|Change in total testosterone post minus pre intervention|baseline and 24 weeks||||ng/dL||Standard Deviation|Mean
2832373|NCT00283803|Primary|Number of Participants With Dose Hold, Dose Reduction, or Treatment Withdrawal for Toxicity.|Patients were monitored for toxicity related treatment modifications from the start of Exisulind through the time that there were withdrawn from study.|From date of first treatment until study withdrawal, assessed up to 10 years.|Of 32 enrolled patients, 19 met criteria to be evaluable for study.|||Participants|||Count of Participants
2832374|NCT00283803|Primary|Time to Hormone-refractory Diseases in Patients Treated With Intermittent Androgen Suppression and Exisulind|Patients were monitored for continued hormonal sensitivity of their disease from the time of the first treatment with Intermittent Androgen Suppression and Exisulind and the time at which point they were considered hormone-refractory (castrate resistant). The development of hormone-refractory disease was one of the criteria for withdraw from study treatment. For this protocol, hormone-refractory was defined as 2 consecutive rising PSAs at least 2 weeks apart while on an LHRH agonist (with or without an anti-androgen).|From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.|Out of 32 enrolled patients, 19 met criteria to be evaluable.|||Weeks||Full Range|Median
2832375|NCT00283803|Primary|"Duration of the First Off-treatment Cycle in Patients Who Have Completed One Cycle of Intermittent Androgen Suppression With the Addition of Exisulind."|Patients were monitored for the amount of time (number of weeks) that passed between the completion of a cycle of Intermittent Androgen Suppression with Exisulind and the need to re-initiate treatment with Intermittent Androgen Suppression. It was hoped that adding Exisulind to standard Androgen Suppression would extend the amount time before disease progression.|From date of first treatment until the date of first documented progression or study withdrawal, whichever came first, assessed up to 10 years.|Of the 32 patients who enrolled, 19 were evaluable.|||Weeks||Full Range|Mean
2832376|NCT00283712|Secondary|Participant Pemphigus Vulgaris Disease Activity Score|The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant's disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment|Baseline to Week 26|Safety Population|||Participants|||Number
2832377|NCT00283712|Secondary|Adverse Events Resulting in Treatment Discontinuation|Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.|Baseline to Week 26|Safety Population|||Participants|||Number
2832378|NCT00283712|Secondary|Participants Who Experienced Severe Infectious Complications|Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population|||Participants|||Number
2832379|NCT00283712|Secondary|Participants Who Experienced Severe Infusion Reactions|Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population|||Participants|||Number
2832380|NCT00283712|Secondary|Participant Duration of Clinical Response|The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.|Baseline to Week 26|Participants in the Intent-to-Treat Population Who Were Responders at Week 18|||Participants|||Number
2832381|NCT00283712|Secondary|Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18|The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.|Baseline to Week 18|Intent-to-Treat with available data|||units on a scale||Standard Deviation|Mean
2832382|NCT00283712|Secondary|Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18|The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline to Week 18|Intent-to-Treat with available data|||units on a scale||Standard Deviation|Mean
2832383|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions|Each participant's prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Erosion Healing|||mg||Standard Deviation|Mean
2832384|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters|Each participant's prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Cessation|||mg||Standard Deviation|Mean
2832406|NCT00283439|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||Day||Standard Error|Mean
2834150|NCT00265330|Primary|Mean Change From Baseline in Standing Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||beats per minute||Standard Deviation|Mean
2832385|NCT00283712|Secondary|Time to 80% Lesion Healing|Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Healing|||Days||Standard Deviation|Mean
2832386|NCT00283712|Secondary|Participant Time to Cessation of New Blisters|Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant's data was missing past that point.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Cessation|||Days||Standard Deviation|Mean
2832387|NCT00283712|Secondary|Participant Modified Response Status at Week 18|Modified responder status was defined as participants achieving a prednisone dosage <=25% of the initial starting dose or <=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat|||Participants|||Number
2832388|NCT00283712|Secondary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Per-protocol|||Participants|||Number
2832389|NCT00283712|Primary|Treatment-Related Adverse Events >= Grade 3 On or Before Week 18|"Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of Skin and Subcutaneous Tissues Disorders were excluded."|Baseline to Week 18|Safety Population|||Participants|||Number
2832390|NCT00283712|Primary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat|||Participants|||Number
2832391|NCT00283686|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat.|||annual change in units on a scale||95% Confidence Interval|Mean
2832392|NCT00283686|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat|||annual change in units on a scale||95% Confidence Interval|Mean
2832393|NCT00283686|Secondary|All-Cause Hospitalizations||Up to 96 months|Intention to treat analysis: All participants who were randomized.|||events|||Number
2832394|NCT00283686|Secondary|Renal Blood Flow|renal blood flow (mL/min/1.73 m^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI).|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat analyses for participants with at least one valid renal blood flow measure.|||annual change in mL/min/1.73 m^2||95% Confidence Interval|Mean
2832395|NCT00283686|Secondary|Left Ventricular Mass Index|Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat for participants with at least one left ventricular mass index measure.|||annual change in g/m^2||95% Confidence Interval|Mean
2832396|NCT00283686|Secondary|Aldosterone|Urinary aldosterone excretion, centrally processed, 24 hour urine collection|Up to 96 months (assessed annually)|Analysis using intention to treat|||annual % change micrograms per 24 hr||95% Confidence Interval|Mean
2832397|NCT00283686|Secondary|Albuminuria|Urine albumin excretion, centrally processed from 24 hour urine collection|Up to 96 months (assessed annually)|Analysis by intention to treat|||annual percent change in mg/24 hr||95% Confidence Interval|Mean
2832398|NCT00283686|Secondary|Kidney Function (eGFR)|The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.|Up to 96 months (6 month assessments)|Analyses were intention to treat: All participants who were randomized.|||ml/min/1.73/m2/yr||95% Confidence Interval|Mean
2832399|NCT00283686|Primary|Study A: Percent Annual Change in Total Kidney Volume|Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.|Baseline and 2-, 4- and 5-year follow-up|Analyses were conducted on all participants who had at least one total kidney volume measurement using intention to treat.|||percentage of Total Kidney Volume||95% Confidence Interval|Mean
2832400|NCT00283595|Secondary|IGF-1 Level|Change in IGF-1 level between baseline and 12 weeks|Baseline, 12 Weeks|The analysis group consisted of individuals who completed study visits after the baseline visit. The three subjects who did not continue in the study discontinued their participation after the baseline visit.|||ng/ml||Inter-Quartile Range|Median
2832401|NCT00283595|Primary|Bone Metabolism|Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks|Baseline, 12 weeks|Only subjects who completed study visits after the baseline visit were included in the analysis. The three subjects who discontinued the study only completed a baseline visit and were therefore not included in the analysis.|||ng/ml||Standard Error|Mean
2832476|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year||5 years||||percentage of participants|||Number
2832407|NCT00283439|Secondary|Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia|Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||Percentage of participants|||Number
2832408|NCT00283439|Primary|Change in Platelet Nadir|Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.|||10^9/L||Standard Error|Mean
2832409|NCT00283400|Secondary|Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1|Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1|3 months after enrollment||||participants|||Number
2832410|NCT00283400|Secondary|Serious Adverse Events|"Serious adverse events included neurological and medical complications and neurological deterioration.~Neurological deterioration was defined as a decline by more than 2 points in the Glasgow Coma Scale."|within 3 months after enrollment||||participants|||Number
2832411|NCT00283400|Primary|Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.|Tolerability outcome: Subject's ability to receive the full allocated human albumin dose without incurring frank congestive heart failure or experiencing anaphylactic reactions that required discontinuation of the treatment. Study would be terminated if 2 or more subjects developed severe or life-threatening heart failure considered to be related (probably, possibly, and definitely) to albumin treatment.|9 days after enrollment|Sample size consideration for this Phase I dose-escalation study was based on the feasibility of recruiting patients in a 3-year study period at 5 sites.The recruitment yield would be a maximum of 80 patients or 20 patients per dosage group. Statistical analyses were mainly descriptive.|||participants|||Number
2832412|NCT00283387|Primary|Urinary Oxalate Excretion|"The patients were randomly assigned oral betaine or placebo for 2 months, followed by a 2 month washout. Each patient then received the alternate study medication for 2 months.~Urinary Oxalate Excretion was measured by oxalate oxidase. Two 24 hour urine collections were obtained at baseline, and during the eighth week of each study period."|baseline, 2 months, 6 months|Per protocol analysis: 10 of 15 enrolled PHI subjects completed the study: 2 withdrew before initiation, 2 were noncompliant, in 1 symptoms led to withdrawal.|||umol/mg||Standard Deviation|Mean
2832413|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)|Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.|2 week in-home trial|Endeavor w/c|||meters/day||Standard Deviation|Mean
2832414|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)|Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.|2 week in-home trial|personal w/c|||meters/day||Standard Deviation|Mean
2832415|NCT00283296|Primary|Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle|Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.|immediately following course completion||||participants|||Number
2832416|NCT00283244|Secondary|Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)|"The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores.~A best response for TOI-L scores is based on change from baseline and coded as:~a change >=+6 improved, <= -6 worsened and otherwise no change.~A best overall score response is coded as:~Improved (2 visit resp. of improved a min. of 28 days apart w/ no interim worsened) No change (not improved; 2 visit resp. of no change or improved a min. of 28 days apart w/ no interim worsened) Worsened (not improved or no change; 2 consecutive worsened) Other (none of the above)"|After each cycle/3 weeks||||participants|||Number
2832417|NCT00283244|Secondary|Toxicity|Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade >=3, treatment related hematologic events (all) and Grade>=3 treatment related non hematologic events that occurred in >=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening.|After each cycle/3 weeks, up to 3 years||||participants|||Number
2832418|NCT00283244|Secondary|Overall Survival|Survival calculated from start of treatment to death from any cause for up to three years.|Up to 3 years||||Months||95% Confidence Interval|Median
2832419|NCT00283244|Secondary|Response Rate|The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Six months||||percentage of participants|||Number
2832420|NCT00283244|Primary|Progression-free Survival|We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Six months||||months||95% Confidence Interval|Median
2832629|NCT00282113|Secondary|Stool Colonization With Bifidobacteria|Using standard culture techniques, we measured how many of the first 11 infants in each arm of the study grew bifidobacteria in their feces after four weeks of treatment.|4 weeks||||Participants|||Number
2832421|NCT00283075|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Dose limiting toxicity (DLT) was defined as:~any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;~any Grade ≥ 3 infection and~any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.~This definition of DLT is in accord with the NCI CTCAE v3.0."|6 months||||Participants who observed DLT|||Number
2832422|NCT00283075|Other Pre-specified|Tumor Marker Response|Tumor marker response after the first implantation with RENCA macrobeads. Responders showed at least a 20% decrease from baseline in Cancer Antigen 19-9 (CA19-9) or Carcinoembryonic Antigen (CEA); Non-responders do not show at least a 20% decrease from baseline in CA19-9 or CEA.|Prior to Implantation and Day 7, Day 14, Day 21 and Day 28 after each implantation|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.|||participants|||Number
2832423|NCT00283075|Secondary|Overall Survival|Overall Survival (OS) was measured as date of first implantation to date of death of any cause, and was analyzed using the Kaplan-Meier method.|From date of RENCA macrobeads implantation until date of death from any cause||||months||95% Confidence Interval|Median
2832424|NCT00283075|Primary|Maximum Tolerated Dose (MTD) of RENCA Macrobeads|"Dose limiting toxicity (DLT) was defined as:~any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;~any Grade ≥ 3 infection and~any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.~This definition of DLT is in accord with the NCI CTCAE v3.0.~Maximum tolerated dose (MTD) was to be identified if, within a cohort, > 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a case, the MTD will have been exceeded, and the administration of the study agent was to cease. MTD would not be considered to have been reached if no DLTs were observed."|6 months||||RENCA Macrobeads/kg|||Number
2832425|NCT00283062|Secondary|Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)|Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.|from treatment initiation up to 19 months after treatment initiation|Safety population: all randomized participants who received any study drug|||participants|||Number
2832426|NCT00283062|Secondary|To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire|"The FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represents the best outcome.~Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size."|from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)|QoL population: The subset of randomized participants who had an evaluable baseline questionnaire and at least one evaluable post-baseline questionnaire. A baseline QoL questionnaire was considered evaluable if it was filled out within 30 days prior to randomization, and no later than the date of randomization.|||score on a scale||Standard Deviation|Mean
2832427|NCT00283062|Secondary|Median Metastasis-free Survival (MFS)|"MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression.~Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median MFS was not to be performed as the study was underpowered.|||participants|||Number
2832428|NCT00283062|Secondary|Median Cancer-specific Survival (CSS)|"The CSS was the time from the date of surgery to the date of death due to prostate cancer.~Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median CSS was not to be performed as the study was underpowered.|||participants|||Number
2832429|NCT00283062|Secondary|Median Overall Survival (OS)|"Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause.~Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any drug.|||participants|||Number
2832430|NCT00283062|Primary|Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression|"PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of~first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks~date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)~first radiological/ histological evidence of tumor progression~death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.|||participants|||Number
2832477|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit||5 years|Similar analysis was performed and the result is provided for the outcome measure #14. The data were collected to answer the outcome measure #14.||||||
2834151|NCT00265330|Primary|Mean Change From Baseline in Standing Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||mm Hg||Standard Deviation|Mean
2832431|NCT00283049|Secondary|Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 Weeks from Baseline|Safety Population|||events/ patient-year||Standard Deviation|Mean
2832432|NCT00283049|Secondary|Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 weeks from Baseline|Safety Population|||Participants|||Number
2832433|NCT00283049|Secondary|Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||mg/dL||Standard Deviation|Mean
2832434|NCT00283049|Secondary|Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||Percentage||Standard Deviation|Mean
2832435|NCT00283049|Secondary|Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||Percent||Standard Deviation|Mean
2832436|NCT00283049|Secondary|Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.|||Percentage|||Number
2832437|NCT00283049|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12||12 weeks from Baseline|Safety Population (excluding patients from Good Clinical Practice [GCP] non-compliant sites)|||Percentage||Standard Deviation|Mean
2832438|NCT00282984|Secondary|Number of Long-Term Quit Responders From Week 9 Through Week 24|Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 24|All Participants population|||participants|||Number
2832439|NCT00282984|Secondary|Cigarettes Smoked Per Day|Cigarettes smoked each day during the first 3 weeks of the treatment phase.|Day 21|All Participants population|||cigarettes per day||Standard Deviation|Mean
2832440|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 24|"Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) Has participant smoked any cigarettes (even a puff) since the last contact? = No AND 2) Has participant used any other tobacco products… since the last contact? = No. Non- responder if the expired CO > 10 ppm at any given timepoint."|Week 9 through Week 24|All Participants population|||participants|||Number
2832441|NCT00282984|Secondary|Number of Participants With a 4 Week Point Prevalence of Smoking Cessation|Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.|Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])|All Participants population|||participants|||Number
2832442|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52|"Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm."|Week 52||||participants|||Number
2832443|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24|"Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm."|Week 24||||participants|||Number
2832444|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12|"Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) Has the participant smoked any cigarettes in the last 7 days? = No AND 2) Has the participant used any other tobacco products in the last 7 days? = No. Participant a non-responder if expired CO > 10 ppm."|Week 12|All Participants population|||participants|||Number
2832445|NCT00282984|Secondary|Number of Long-Term Quit Responders|Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 52|All participants population|||participants|||Number
2832446|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 52|"Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) Has participant smoked any cigarettes (even a puff) since last contact? = No AND 2) Has participant used any other tobacco products… since last contact? = No. Participant a non-responder if expired CO > 10 ppm."|Week 9 through Week 52|All participants population|||participants|||Number
2832447|NCT00282984|Primary|Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)|Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.|weeks 9 through 12|"Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as All Participants population in this report."|||participants|||Number
2832448|NCT00282971|Secondary|Change From Baseline in FEV1 at Week 24 LOCF||24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward.|||Liter||Standard Deviation|Mean
2832449|NCT00282971|Secondary|Percentage of Participants Achieving Glycemic Control by Visit|2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward.|||Percentage of participants|||Number
2832450|NCT00282971|Primary|Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|[(week 24 value - baseline value)/baseline value]*100%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.|||percentage change||Standard Deviation|Mean
2832451|NCT00282919|Secondary|Parasite Clearance Time|Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.||||||
2832452|NCT00282919|Secondary|Fever Clearance Time|Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature).|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.||||||
2832453|NCT00282919|Secondary|Percentage of Participants With Gametocyte Clearance|Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.|Day 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."|||percentage of participants||90% Confidence Interval|Number
2832454|NCT00282919|Secondary|Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42|"Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here N (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28."|Day 7, 14, 21, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."|||percentage of participants||90% Confidence Interval|Number
2832455|NCT00282919|Secondary|Percentage of Participants With Clinical Cure|Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).|Day 3, 7, 28, and 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."|||percentage of participants||90% Confidence Interval|Number
2832456|NCT00282919|Secondary|Percentage of Participants With Resistance to Treatment|Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.|Days 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."|||percentage of participants|||Number
2832457|NCT00282919|Secondary|Percentage of Participants With Late Treatment Failures (LTF)|LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."|||percentage of participants||90% Confidence Interval|Number
2832669|NCT00281827|Secondary|Number of Patients Alive at 56 Months (End of Study)|Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).|Up to 56 months|Calculated from study entry date to date of death or censored at date of last contact.|||Participants|||Number
2832458|NCT00282919|Secondary|Percentage of Participants With Early Treatment Failures (ETF)|ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline).|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."|||percentage of participants||90% Confidence Interval|Number
2832459|NCT00282919|Primary|Percentage of Participants With Parasite Clearance at Day 28|"Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here N (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28."|Day 28|Parasitological per protocol (PP) population: Participants who had study drug for 3 days unless treatment failure, no concomitant anti-malarial unless designated treatment failure, had test of cure at Day 28, baseline smear with parasitemia between 1000-100000 parasites/microliter, rapid diagnostic test positive for P falciparum, history of fever.|||percentage of participants||90% Confidence Interval|Number
2832460|NCT00282867|Post-Hoc|Target Glucose Concentration|glucose in target range in first 24 hours|first 24 hours after initiation of treatment|"Per protocol no analysis of this endpoint was performed in the usual care group."|||participants|||Number
2832461|NCT00282867|Other Pre-specified|Symptomatic Hypoglycemia|symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period|up to 5 days||||participants|||Number
2832462|NCT00282867|Primary|Hypoglycemic Events|hypoglycemic events|up to 5 days||||participants|||Number
2832463|NCT00282867|Secondary|Favorable 3 Month Modified Rankin|3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.|3 months||||percentage of participants|||Number
2832464|NCT00282841|Primary|Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)|The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA.|within 24 hours after reference method|Based on the assumption that all target intracranial vessel segments could be visualized with either one of the reference methods, CTA or MRA, in all patients enrolled, the transcranial ultrasound data was analyzed to assess how many of the target vessel segments could be visualized in comparison to the reference method.|||participants|number of vessel segments visualized||Number
2832465|NCT00282828|Secondary|Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Change from Week 10 to Week 22|This analysis was conducted in Phase I non-responders, randomized to receive 12 weeks of continued sertraline plus the addition of clonazepam, switch to venlafaxine, or prolonged sertraline plus placebo.|||units on a scale||Standard Deviation|Mean
2832466|NCT00282828|Primary|Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Measured at Week 22 (Endpoint)|The present analysis was conducted in the modified ITT population (n=181), with remission based on week 22 LSAS for study completers (n=154, and last Phase II LSAS for the 27 patients who terminated early.|||participants|||Number
2832467|NCT00282815|Secondary|Barthel Index|Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).|3 months||||units on a scale (range 0-100)||Inter-Quartile Range|Median
2832468|NCT00282815|Primary|Number of Subjects Who Withdraw From Study.|Prespecified outcome.|3 months||||participants|||Number
2832469|NCT00282815|Primary|Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.||3 months|Data not available on one sham participant (lowering n from 11 to 10 in the shame group).|||Hours/participant||Inter-Quartile Range|Median
2832470|NCT00282672|Secondary|5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.||5 years||||percentage of participants|||Number
2832471|NCT00282672|Secondary|5 Year Extension: Serious Adverse Event Incidence||5 years||||participants|||Number
2832472|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year||4 years||||percentage of participants|||Number
2832473|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year||3 years||||percentage of participants|||Number
2832474|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year||4 years||||percentage of participants|||Number
2832475|NCT00282672|Secondary|5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year||5 years||||percentage of participants|||Number
2834510|NCT00262119|Secondary|Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay||2 years|||||||
2832478|NCT00282672|Secondary|For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)||5 years|41 LGD patients and 21 HGD subjects completed the 5 year study and used for analysis.|||percentage of participants|||Number
2832479|NCT00282672|Secondary|Adverse Event Incidence|Data reported in the adverse event section|12 months for Treatment and Sham Comparison||||Adverse event occurrences|||Number
2832480|NCT00282672|Secondary|Quality of Life Questionnaire (Baseline v. 12 and 24 Mos)||0, 12, and 24 months|Data had not been collected consistently to analyze the data.||||||
2832481|NCT00282672|Secondary|Subject Discomfort : Chest Pain Score on Day 1|Chest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain|Day 1 , if ablated||||Scores on a scale||Inter-Quartile Range|Median
2832482|NCT00282672|Secondary|Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)||5 year||||participants|||Number
2832483|NCT00282672|Secondary|Histological Clearance of IM (% Biopsies)|% of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated.|12 months||||percentage of participants|||Number
2832484|NCT00282672|Secondary|Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.||12 Month|16 HGD Sham procedure subjects crossed over to RFA treatment after one year|||percentage of participants|||Number
2832485|NCT00282672|Secondary|The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup||12 months||||percentage of participants|||Number
2832486|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia|5 years||||percentage of participants|||Number
2832487|NCT00282672|Primary|Durability of Eradication With no Additional Treatments||5 year|41 LGD subjects and 32 HGD subjects completed 5 year visit|||percentage of participants|||Number
2832488|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated.|5 years|patient who made it to the 5 year visit|||percentage of participants|||Number
2832489|NCT00282672|Primary|The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.|% of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated.|24 Month||||percentage of participants|||Number
2832490|NCT00282672|Primary|The % of Patients With Complete Eradication of Dysplasia at 12 Month|% of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-D at one year.|||percentage of participants|||Number
2832491|NCT00282672|Primary|The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month|% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-IM at one year.|||percentage of participants|||Number
2832492|NCT00282568|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event was defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the day of last dose plus 10 days (approximately 60 months).|Modified safety analysis set|||participants|||Number
2832493|NCT00282568|Secondary|Number of Participants Returning to Permanent Dialysis|Permanent dialysis defined as dialysis for longer than 30 days.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832494|NCT00282568|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis) or death. GBM = glomerular basement membrane.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||participants|||Number
2832495|NCT00282568|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
2832496|NCT00282568|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
2832497|NCT00282568|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832498|NCT00282568|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832499|NCT00282568|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832500|NCT00282568|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|"Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported."|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||participants|||Number
2832501|NCT00282568|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection, the median number of days from enrollment to the date of biopsy confirmation. Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||days||Full Range|Median
2832502|NCT00282568|Secondary|Time to Event for Graft Non Survival|For participants with graft loss, the median number of days from enrollment to graft loss. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||days||Full Range|Median
2832503|NCT00282568|Secondary|Time to Event for Patient Non Survival|For participants who died on study, the median number of days from enrollment to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.|||days||Full Range|Median
2832504|NCT00282568|Secondary|Change From Baseline in Creatinine Clearance|Renal function was assessed using creatinine clearance levels calculated using the Cockcroft-Gault formula, over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set|||mL/minute||Standard Deviation|Mean
2832505|NCT00282568|Secondary|Change From Baseline in Serum Creatinine|Renal function was assessed using serum creatinine levels over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. “N” indicates the number of participants with available data at each time point.”|||mg/dL||Standard Deviation|Mean
2832506|NCT00282568|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participants death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.|||percentage of participants||95% Confidence Interval|Number
2832507|NCT00282568|Primary|Patient Survival|Patient Survival defined as any participant who did not die by the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.|||percentage of participants||95% Confidence Interval|Number
2832508|NCT00282568|Primary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|The time to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.|||hours||Standard Deviation|Mean
2832509|NCT00282568|Primary|Minimum Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 24-hour time point post- dose, prior to receiving the next dose.|Days 1 and 7 (tacrolimus) and Days 14 and 21 (tacrolimus MR), 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.|||ng/mL||Standard Deviation|Mean
2832510|NCT00282568|Primary|Maximum Observed Concentration (Cmax) of Tacrolimus|The maximum concentration was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set.|||ng/mL||Standard Deviation|Mean
2832511|NCT00282568|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||percentage of participants||95% Confidence Interval|Number
2832512|NCT00282568|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the trapezoidal rule.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set, defined as patients with all five complete pharmacokinetic profiles (two tacrolimus and three tacrolimus MR).|||ng*hr/mL||Standard Deviation|Mean
2832513|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint|Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.|Baseline to Week 6 (endpoint)|Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832514|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer|Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.|Baseline to week 6 (endpoint)|Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832515|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating|Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832516|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject|Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832517|NCT00282464|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832518|NCT00282464|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score|Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.|Baseline to week 6 (endpoint)|Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832519|NCT00282464|Secondary|Change in Global Assessment of Functioning (GAF)|Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.|Baseline to week 6 (Endpoint)|Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190|||score on scale||Standard Error|Least Squares Mean
2832520|NCT00282464|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse|Baseline to Week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."|||score on scale||Standard Error|Least Squares Mean
2832521|NCT00282464|Secondary|Change in Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."|||score on scale||Standard Error|Least Squares Mean
2832522|NCT00282464|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6.|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."|||score on scale||Standard Error|Least Squares Mean
2832537|NCT00282438|Primary|Presence of Toxicity|Daily assessment will be made with regards to toxicity by one of the protocol investigators.National Cancer Institute Common Toxicity Criteria will be used to grade all non-hematologic toxicities. Toxicity grades as follows: 1 = Mild; 2 = Moderate; 3 = Severe and undesirable; 4 = life threatening or disabling ; 5 = Death|For length of hospital stay (until discharge).||||participants|||Number
2832523|NCT00282464|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
2832524|NCT00282464|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||score on scale||Standard Error|Least Squares Mean
2832525|NCT00282464|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
2832526|NCT00282464|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
2832527|NCT00282464|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
2832528|NCT00282464|Secondary|Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)|Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
2832529|NCT00282464|Secondary|Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."|||score on scale||Standard Error|Least Squares Mean
2832530|NCT00282464|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 - 6."|||score on scale||Standard Error|Least Squares Mean
2832531|NCT00282464|Secondary|Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7|Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||Participants|||Number
2832532|NCT00282464|Secondary|Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12|Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.|Week 1 to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||Participants|||Number
2832533|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Baseline to Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||Participants|||Number
2832534|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score|Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"|||participants|||Number
2832535|NCT00282438|Primary|Time to Disease Progression|Worsening symptoms, pulmonary function studies, cardiac function and arrhythmia including EKG assessments, and neurological symptoms.|Participants are to be followed at 6 months and then yearly until 5 years||||months|||Number
2832536|NCT00282438|Primary|Survival|Patient has not died.|Participants are to be followed at 6 months and then yearly until 5 years||||Participants|||Count of Participants
2832541|NCT00282347|Secondary|Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52|The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Units on a scale||Standard Deviation|Mean
2832542|NCT00282347|Secondary|Time to Achieve a Complete Renal Response||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Weeks||95% Confidence Interval|Median
2832543|NCT00282347|Secondary|British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks|The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Units on a scale||Standard Deviation|Mean
2832544|NCT00282347|Secondary|Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of > 3.0 were included in the analysis.|||Percentage of participants|||Number
2832545|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Percentage of participants|||Number
2832546|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 24 to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Percentage of participants|||Number
2832547|NCT00282347|Primary|Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52|A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).|||Percentage of participants|||Number
2832548|NCT00282334|Primary|Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months|Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups|baseline and 6 months|Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.|||mm Hg||Standard Deviation|Mean
2832549|NCT00282334|Primary|Difference in Number of Patients Who Reached Target Blood Pressure||6 months|||||||
2832550|NCT00282308|Secondary|Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|"Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate."|Week 24|Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.|||Percentage of patients|||Number
2834511|NCT00262119|Secondary|Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation||2 years|||||||
2832551|NCT00282308|Secondary|Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group B|Patients received an intradermal injection of C. albicans on the volar surface of the forearm on Day 1 and Week 24 for Group A or on Day 1 and Week 12 for Group B. Forty-eight to 72 hours after injection, patients were evaluated for a delayed-type hypersensitivity response by measuring the diameter of induration (palpable raised, hardened area of the forearm skin). A positive response to the C. albicans skin test was defined as at least 5 mm in diameter of induration.|Day 1 to Week 24 for Group A and Day 1 to Week 12 for Group B|Skin test per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion, had Day 1 and Week 24 skin tests, and who provided complete diameter of induration readings. Group B – All patients randomized to Group B who had Day 1 and Week 12 skin tests and who provided complete diameter of induration readings.|||Percentage of patients|||Number
2832552|NCT00282308|Secondary|Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin|Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.|Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||IU/mL||95% Confidence Interval|Geometric Mean
2832553|NCT00282308|Secondary|Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine|Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||µg/mL||95% Confidence Interval|Geometric Mean
2832554|NCT00282308|Secondary|Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine|Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||IU/mL||95% Confidence Interval|Geometric Mean
2832555|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
2832556|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
2832565|NCT00282295|Secondary|Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies|Antibody titers are presented as geometric mean titers (GMTs).|PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Titers||95% Confidence Interval|Geometric Mean
2832586|NCT00282256|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||participants|||Number
2832557|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
2832558|NCT00282308|Secondary|Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
2832559|NCT00282308|Primary|Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.|||Percentage of patients|||Number
2832560|NCT00282295|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Day 0 - Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2832561|NCT00282295|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.|Within the 31-day (Days 0-30) period after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2832562|NCT00282295|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms [gastro sympt]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.|Within 4-days (Days 0-3) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
2832563|NCT00282295|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).|Within 4-days (Day 0-3) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
2832564|NCT00282295|Secondary|Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies|Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.|At Month 2 (one month after vaccination with Menactra vaccine)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832566|NCT00282295|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Month 2 (one month post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol|||EL.U/mL||95% Confidence Interval|Geometric Mean
2832567|NCT00282295|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0 before (PRE) Boostrix vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2832568|NCT00282295|Secondary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.|At Month 2 (one month post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832569|NCT00282295|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||IU/mL||95% Confidence Interval|Geometric Mean
2832570|NCT00282295|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||IU/mL||95% Confidence Interval|Geometric Mean
2832571|NCT00282295|Secondary|Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|"Booster responses for anti-D and anti-T antibodies were defined as:~for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine."|At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832572|NCT00282295|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).|PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832573|NCT00282295|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 2 (one month post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832574|NCT00282295|Secondary|Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Day 0 (PRE) before Boostrix vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832575|NCT00282295|Primary|Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)|Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.|One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832576|NCT00282295|Primary|Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|"Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as:~for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine."|At Month 1 (post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832577|NCT00282295|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1 (post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol|||EL.U/mL||95% Confidence Interval|Geometric Mean
2832578|NCT00282295|Primary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).|At Month 1 (post Boostrix vaccination)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.|||Participants|||Count of Participants
2832579|NCT00282282|Secondary|Disease Response.|Disease response was assessed as 2 year progression-free survival. The median follow-up time was 1.84 years. The percentage of participants with who reached this timepoint with no disease progression are reported.|2 years||||percentage of participants||95% Confidence Interval|Number
2832580|NCT00282282|Secondary|Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation|The percentage of participants with ≥90 percent donor-derived hematopoeisis was assessed around day +100 using peripheral blood chimerism.|100 days||||percentage of participants|||Number
2832581|NCT00282282|Primary|Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus.|All participants received tacrolimus and sirolimus in this one arm study. There were no participants considered unevaluable for this measure (deceased prior to day 100). The total number of people who developed grade II-IV aGVHD before day 100 are reported here.|100 days|Participants who lived more than 30 days posttransplant were considered evaluable. Incidence of grade II-IV aGVHD was adjusted for participants who had aGVHD off-treatment.|||participants|||Number
2832582|NCT00282256|Secondary|Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests|"An adverse event (AE) is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 54 months).|Modified safety analysis set defined as all participants who took at least 1 dose of both tacrolimus and tacrolimus MR formulation during the pharmacokinetic period of the study.|||participants|||Number
2832583|NCT00282256|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.|||participants|||Number
2832584|NCT00282256|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 54 months).|||||||
2832585|NCT00282256|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 54 months).|||||||
2834152|NCT00265330|Primary|Mean Change From Baseline in Standing Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||mm Hg||Standard Deviation|Mean
2832588|NCT00282256|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||participants|||Number
2832589|NCT00282256|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||participants|||Number
2832590|NCT00282256|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||days||Full Range|Median
2832591|NCT00282256|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.|||days||Full Range|Median
2832592|NCT00282256|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set who died on study.|||days||Full Range|Median
2832593|NCT00282256|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte. necrosis|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||percentage of participants|||Number
2832594|NCT00282256|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to reach the first observed maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.|||hours||Full Range|Median
2832595|NCT00282256|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.|||percentage of participants||95% Confidence Interval|Number
2832596|NCT00282256|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the end of the study.|From enrollment until the end of study (up to 54 months).|The Modified Full Analysis Set included all patients who took at least 1 dose of tacrolimus MR formulation during the extended treatment period.|||percentage of participants||95% Confidence Interval|Number
2832597|NCT00282256|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR).|Pharmacokinetic evaluable set.|||ng/mL||Standard Deviation|Mean
2832598|NCT00282256|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.|||ng/mL||Standard Deviation|Mean
2832626|NCT00282152|Primary|Levodopa Equivalents, Change From Baseline|100 mg of levodopa with a dopa-decarboxylase inhibitor = 133 mg of controlled-release levodopa preparations = total levodopa dose + (total levodopa dose x 0.33) of levodopa with dopa-decarboxylase and entacapone = 1 mg of pergolide, pramipexole, or lisuride = 5 mg of ropinirole = 3.3 mg of rotigotine|baseline to 24 months||||mg||95% Confidence Interval|Mean
2832599|NCT00282256|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 and AUC 12-24 for the morning and afternoon doses.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The pharmacokinetic evaluable set was defined as all patients who completed both pharmacokinetic profiles: one for tacrolimus, and one for tacrolimus MR. A complete pharmacokinetic profile was considered to be a profile that was adequate to determine AUC0-24, Cmax, and Cmin.|||ng*hr/mL||Standard Deviation|Mean
2832600|NCT00282243|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 60 months).|Modified safety analysis set.|||participants|||Number
2832601|NCT00282243|Secondary|Change From Baseline in Total Bilirubin|Hepatic function was assessed by measuring total bilirubin over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set. N indicates the number of participants with available data at each time point."|||mg/dL||Standard Deviation|Mean
2832602|NCT00282243|Secondary|Change From Baseline in Aspartate Aminotransferase (AST)|Hepatic function was assessed by measuring aspartate aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set. “N” indicates the number of participants with available data at each time point.|||U/L||Standard Deviation|Mean
2832603|NCT00282243|Secondary|Change From Baseline in Alanine Aminotransferase (ALT)|Hepatic function was assessed by measuring alanine aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. N indicates the number of participants with available data at each time point."|||U/L||Standard Deviation|Mean
2832604|NCT00282243|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||participants|||Number
2832605|NCT00282243|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
2832606|NCT00282243|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).|||||||
2832607|NCT00282243|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832608|NCT00282243|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832609|NCT00282243|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||participants|||Number
2832610|NCT00282243|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||participants|||Number
2832627|NCT00282152|Primary|Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score|The primary hypothesis of this feasibility trial was focused on safety and tolerability and that the DBS+ODT group would not worsen more quickly than the ODT group.|baseline to 24 months|all 29 subjects that completed at least one follow up visit were included in the primary analysis following intent to treat principle|||months||95% Confidence Interval|Mean
2832611|NCT00282243|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.|||days||Full Range|Median
2832612|NCT00282243|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.|||days||Full Range|Median
2832613|NCT00282243|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.|||days||Full Range|Median
2832614|NCT00282243|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||percentage of participants||95% Confidence Interval|Number
2832615|NCT00282243|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to the first occurrence to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set|||hours||Standard Deviation|Mean
2832616|NCT00282243|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set|||percentage of participants||95% Confidence Interval|Number
2832617|NCT00282243|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extended treatment period of the study.|||percentage of participants||95% Confidence Interval|Number
2832618|NCT00282243|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Days 14 and 42 at 12 hours post-dose (tacrolimus) and Days 28 and 56 at 24 hours post-dose (for tacrolimus MR).|Pharmacokinetic evaluable set|||ng/mL||Standard Deviation|Mean
2832619|NCT00282243|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set|||ng/mL||Standard Deviation|Mean
2832620|NCT00282243|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 for the morning (0-12 hour) and afternoon (12-24 hour) doses.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set defined as all patients with four complete pharmacokinetic profiles (two tacrolimus and 2 tacrolimus MR).|||ng*hr/mL||Standard Deviation|Mean
2832621|NCT00282152|Secondary|Change in Total UPDRS|"The Total Unified Parkinson's Disease Rating Scale (UPDRS) is a composite scale, consisting of four sections that evaluate mood and behavior, activities of daily living, motor symptoms, and complications of medical therapy.~Range is 0 to 16, with 16 being maximal disability"|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
2832622|NCT00282152|Secondary|Change in UPDRS Part IV, Complications of Therapy|Score: 0-23 0 =no complications, 23 = most complications|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
2832623|NCT00282152|Secondary|Change in UPDRS Part III, Motor Examination, Excluding Rigidity|Score: 0-56 0 = full movement, 56 = most limited|baseline to 24 months||||change in units on a scale||95% Confidence Interval|Mean
2832624|NCT00282152|Secondary|Change in UPDRS Part II, Activities of Daily Living|Score: 0-52 0 =normal, 52 = most limited|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
2832625|NCT00282152|Secondary|Change in UPDRS Part I, Mentation Behavior and Mood|Score: 0-16 0 =normal, 16 = most disability|baseline to 24 months||||units on a scale||95% Confidence Interval|Mean
2832630|NCT00282113|Primary|Weight Gain|Weight at five weeks minus birth weight|5 weeks|Infants left the study as they were discharged from the NICU, therefore many of the infants were not available for measurement at five weeks. The number reported is the number of infants remaining in the study at 5 weeks. Weight in grams is reported.|||Grams||Standard Deviation|Mean
2832631|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)||2 years||||participants|||Number
2832632|NCT00282087|Secondary|Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)|Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)|2 years||||participants|||Number
2832633|NCT00282087|Secondary|Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable|||participants|||Number
2832634|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable|||participants|||Number
2832635|NCT00282087|Secondary|Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)|Mitotic rate is measured in mitoses per 10 high-power fields|2 years||||mitoses per 10 high-power fields||Full Range|Median
2832636|NCT00282087|Secondary|Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)|AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only|2 years||||participants|||Number
2832637|NCT00282087|Secondary|Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)||2 years||||participants|||Number
2832638|NCT00282087|Secondary|Correlation Between Age and Tumor Response to Treatment (PFS)||2 years||||years||Full Range|Median
2832639|NCT00282087|Secondary|Tolerability/Toxicity of This Regimen|Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.|Every 28 days during dosing and then every 3 months thereafter until patient comes off study||||number of major toxicity events|||Number
2832640|NCT00282087|Primary|Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS||Every 3 months up to two years||||percentage of participants||95% Confidence Interval|Number
2832641|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Overall Survival (OS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. OS is time in weeks from the start of study treatment to date of death due to any cause. Relationship of OS versus AUCss was determined as median OS in participants with high AUCss [AUCss >= median AUCss] or low AUCss [AUCss < median AUCss].|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and OS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.|||weeks||Full Range|Median
2832642|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. PFS is median time from first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Relationship of PFS versus AUCss was determined as median PFS in participants with high AUCss [AUCss greater than or equal to (>=) median AUCss] or low AUCss [AUCss less than (<) median AUCss].|Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and PFS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.|||weeks||Full Range|Median
2832643|NCT00282048|Other Pre-specified|Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)|AUCss: pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods, computed as each participant's average total daily dose (accounting for dose reductions and any recorded missed doses) divided by population estimated posthoc individual apparent clearance (CL/F), i.e., AUCss = Daily Dose/(CL/F), where F refers to the oral bioavailability, and CL refers to the systemic clearance. PR: responses with at least 30% decrease in sum of longest dimensions of target lesions using baseline (pre-treatment) sum of longest dimensions as reference. Logistic regression with general linear model was applied to data of PR using AUCss; PR was correlated with AUCss as fold increase in odds of PR with increase in AUCss. Fold increase was calculated as exponent of product of logistic regression slope coefficient and unit change of AUCss.|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both Pharmacokinetic (PK) and PR data were available were included in analysis.|||Ratio|||Number
2832644|NCT00282048|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI) Score|FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.|||Units on a Scale||95% Confidence Interval|Mean
2832645|NCT00282048|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|||||||
2832670|NCT00281827|Secondary|Number of Patients Alive at 2 Years (Survival)|Participants who were alive at 2 years from date of enrollment.|24 Months|Calculated from date of first date of enrollment to date of death.|||Participants|||Number
2832646|NCT00282048|Secondary|Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score|FKSI-DRS is a subset of FKSI which is a questionnaire for FACT -Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.|||Units on a Scale||95% Confidence Interval|Mean
2832647|NCT00282048|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the first dose for the last participant|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.|||Days||95% Confidence Interval|Median
2832648|NCT00282048|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
2832649|NCT00282048|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.|||Days||95% Confidence Interval|Median
2832650|NCT00282048|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.|||Percentage of Participants||95% Confidence Interval|Number
2832651|NCT00281957|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).|Eligible patients who had received any hydroxyurea|||Participants|||Number
2832652|NCT00281957|Secondary|One-year Overall Survival||One year after registration||||Percent of population||95% Confidence Interval|Number
2832653|NCT00281957|Primary|4-month Progression-free Survival|Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.|4 months after registration||||Percent of population||95% Confidence Interval|Number
2832654|NCT00281957|Primary|Response Rate (Complete and Partial)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 8 weeks until progression||||Percent of participants||95% Confidence Interval|Number
2832655|NCT00281918|Secondary|Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)|The time from randomization to the start of a new treatment.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, who started a new CLL treatment.|||Days||95% Confidence Interval|Median
2832656|NCT00281918|Secondary|Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.|Median observation time was approximately 66.4 months|Intent-to-treat population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2832671|NCT00281827|Secondary|Number of Patients Alive at 1 Year (Survival)|Participants who were alive at one year from date of enrollment .|12 Months|Calculated from date of first date of enrollment.|||Participants|||Number
2832657|NCT00281918|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause).|||Days||95% Confidence Interval|Median
2832658|NCT00281918|Secondary|Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death).|||Days||95% Confidence Interval|Median
2832659|NCT00281918|Secondary|Final Analysis: Time to Event-free Survival Event|Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death.|||Days||95% Confidence Interval|Median
2832660|NCT00281918|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants who died.|||Days||95% Confidence Interval|Median
2832661|NCT00281918|Primary|Final Analysis: Time to Progression-free Survival Event|Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.|||Days||95% Confidence Interval|Median
2832662|NCT00281918|Secondary|Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days to an event|||Number
2832663|NCT00281918|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days|||Number
2832664|NCT00281918|Secondary|Event-free Survival (EFS)|Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days||Full Range|Median
2832665|NCT00281918|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time at time of analysis was approximately 21 months|The Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.|||Days||Full Range|Median
2832666|NCT00281879|Primary|Number of Participants With Disease Free Survival (DFS).|"Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies.~Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer."|Duration of the study; Up to 2 years|||||||
2832667|NCT00281840|Secondary|Response Rate|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|5 years|Patients with evaluable tumors at the end of the study|||participants|||Number
2832668|NCT00281840|Primary|Time to Progression|The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.|5 yrs after treatment|Patients who received at least one treatment on study|||Months||95% Confidence Interval|Mean
2832672|NCT00281827|Secondary|Number of Patients Disease-free at 2 Years|Calculated from date of enrollment to date of recurrence or death, whichever came first|2 Years||||Participants|||Number
2832673|NCT00281827|Secondary|Number of Patients Disease-free at 1 Year|Calculated from date of enrollment to date of recurrence or death, whichever came first|1 year|Calculated from study entry date to date of recurrence or date of death, whichever came first.|||Participants|||Number
2832674|NCT00281827|Primary|Number of Patients Reporting Clinical Response|Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.|At end of 3 -21 day cycles of treatment|2 of 22 patients did not receive all 3 drugs for all 3 cycles - only 20 patients achieved this and are thereby included here in the evaluable population analysis.|||Participants|||Number
2832675|NCT00281697|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2832676|NCT00281697|Secondary|Objective Response|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2832677|NCT00281697|Secondary|One-year Survival|Percentage of patients who survived 1 year in the study.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Percentage of patients||95% Confidence Interval|Number
2832678|NCT00281697|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
2832679|NCT00281697|Secondary|Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)|Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
2832680|NCT00281697|Primary|Progression-free Survival|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
2832681|NCT00281684|Secondary|Time Prior to the First Measurable Concentration (T-lag) and Time to Maximum Observed Plasma Concentration (T-max)|Cannulation of the forearm vein was performed prior to surgery for serial pharmacokinetic blood sampling. The cannula was kept patent by means of a 0.9% saline lock. Blood was sampled via the intravenous cannula with 1 mL of blood being withdrawn prior to each sample and discarded. Venipuncture was allowed if necessary (e.g., cannulation failure).|At pre-dose (Baseline) and at between 20-40minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post randomization and at final follow-up (Day 28)|ITT Population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2832682|NCT00281684|Secondary|Plasma Concentrations: Average Concentration (C-avg) [0-rescue] and Maximum Concentration (C-max) of SB705498|Cannulation of the forearm vein was performed prior to surgery for serial pharmacokinetic blood sampling. The cannula was kept patent by means of a 0.9% saline lock. Blood was sampled via the intravenous cannula with 1 mL of blood being withdrawn prior to each sample and discarded. Venipuncture was allowed if necessary (e.g., cannulation failure).|At pre-dose on Baseline (Day 1) and at between 20-40 minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post dose and at final follow-up (Day 28)|ITT Population. Only those participants available at the specified time points were analyzed.|||Microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2833506|NCT00271544|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
2832683|NCT00281684|Secondary|Area Under Curve (AUC)(0-rescue) and AUC(0-t) of SB705498|Cannulation of the forearm vein was performed prior to surgery for serial pharmacokinetic blood sampling. The cannula was kept patent by means of a 0.9% saline lock. Blood was sampled via the intravenous cannula with 1 mL of blood being withdrawn prior to each sample and discarded. Venipuncture was allowed if necessary (e.g., cannulation failure).|At pre-dose on Baseline (Day 1) and at between 20-40 minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post dose and at final follow-up (Day 28)|ITT Population. Only those participants available at the specified time points were analyzed.|||Microgram*hour per milliliter (ug*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2832684|NCT00281684|Secondary|Number of Participants With Abnormal Urine Parameters|Urinalysis parameters included protein, glucose, ketones, bilirubin, blood, urobilinogen, urine leukocyte esterase (ULE) test for detecting WBC (via dipstick method). The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine can be read as negative, Trace, +, ++, +++ and ++++ indicating proportional concentrations in the urine sample. The results above ++ that is ++, +++ and ++++ were reported as abnormal and the corresponding parameters were considered as abnormal parameters. Number of participants with abnormal urinalysis parameters were reported.|Up to 28 days|Safety population.|||Participants|||Count of Participants
2832685|NCT00281684|Secondary|Number of Participants With Clinical Chemistry/ Hematology Values/ Serum Hormones Values of Potential Clinical Concern|Hematology parameters included hemoglobin, packed cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, red blood cell count, white blood cell (WBC) count, platelets and differential WBC count. Clinical chemistry parameters included sodium, potassium, urea, creatinine, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase (GGT), lactate dehydrogenase, calcium, magnesium, phosphate, cholesterol, high density lipoprotein cholesterol, triglycerides, glucose and creatinine kinase. Only those parameters for which at least one value of potential clinical concern was reported are presented.|Up to 28 days|Safety population.|||Participants|||Count of Participants
2832686|NCT00281684|Secondary|Change From Baseline for Vital Signs-Body Temperature|Tympanic temperature was assessed at screening, pre-dose and then at 2, 4, 6, 8, 10 and discharge (approximately 24 hours) post-Baseline. Temperature was also recorded at the follow-up visit. The Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) to 24 hours post Baseline|Safety population. Only those participants available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2832687|NCT00281684|Secondary|Change From Baseline for Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Supine SBP and DBP measurements were performed with the participant in a supine position after the participant has rested for at least 5 minutes. Assessment was completed pre-dose and then at 2, 4, 6, 8, 10 and discharge (approximately 24 hour) post randomization. Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) to 24 hours post Baseline|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2832688|NCT00281684|Secondary|Number of Participants With Second Degree Atrioventricular Block Over 24 Hours by Holter Tape|Continuous ambulatory Holter ECG monitoring was performed for a 24-hour period at screening (Day -14 to Day -1) and from pre-dose (post surgery) to approximately 20 hours post-randomization. Number of participants with second degree atrioventricular block over 24 hours by Holter tape are presented.|Up to 24 hours post-dose|Safety population.|||Participants|||Count of Participants
2832689|NCT00281684|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Paper ECG traces were recorded at a standard paper speed of 25 millimeter/second and gain of 1mVolt/10 millimeter, using 2.5x4 format with lead II rhythm strip. Cardiac intervals were checked by a physician and then transcribed into the case report form. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) ECG findings are presented.|28 days|Safety population.|||Participants|||Count of Participants
2832690|NCT00281684|Secondary|Number of Participants With Adverse Events (AE) Over Time|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|Up to Follow-up (28 days)|The Safety population which comprised of all participants who were randomized and took at least one capsule of study medication.|||Participants|||Count of Participants
2832691|NCT00281684|Secondary|Number of Participants From First Rescue Medication Use to Second Rescue Analgesic Request|Ibuprofen 400 mg was provided as rescue medication to be taken as required. The time that rescue medication was administered was recorded on the case report form. Number of participants using the second rescue medication from the time the first rescue medication was used are presented.|From first dose of rescue medication to second dose of rescue medication|ITT Population.|||Participants|||Count of Participants
2832692|NCT00281684|Secondary|Number of Participants Requiring Rescue Medication Over Time|Ibuprofen 400 mg was provided as rescue medication to be taken as required. The time that rescue medication was administered was recorded on the case report form. Number of participants requiring rescue medication up to 10 hour post-dose are presented.|Up to 10 hour post-dose|ITT Population.|||Participants|||Count of Participants
2832732|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
2832693|NCT00281684|Secondary|VAS Mean Pain Scores From the Time of Rescue Medication up to 10 Hours Post Randomization|Pain intensity was assessed using VAS. VAS was a subjective assessment of post-operative pain intensity. Participants rated the pain intensity at the time of assessment by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on extreme left, i.e., 0 mm indicated no pain and extreme right that is 100 mm indicated worst pain imaginable. This scale has no subscales.|From the time of rescue medication to 10 hours post randomization|ITT Population. Only those participants who used rescue medication were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2832694|NCT00281684|Secondary|Number of Participants With Different Global Evaluation or Overall Impression of Study Medication Use and at 10 and 24 Hours Post Randomization|Participants subjectively assessed their overall impression (global evaluation) of the study medication using a 4-point categorical scale, where 1= poor, 2= fair, 3= good and 4= excellent. Participants were provided with a list of adjectives and were asked to select the word by checking the box that best rated the study medication that they received for pain relief. The number associated with the adjective chosen by the participant constituted the global evaluation score. The study coordinator or designee transcribed the number corresponding to the selected adjective onto the case report form. The Global Evaluation was completed prior to receiving the first rescue medication, at 10 hours post-dose and prior to discharge from the unit.|Prior to first rescue medication use and at 10 and 24 hours post randomization|ITT population.|||Participants|||Count of Participants
2832695|NCT00281684|Secondary|Elapsed Time From Study Drug Administration to Rescue Analgesic Request|Duration of Analgesic Effect (Time to First Rescue medication from study drug administration) is presented. Ibuprofen 400 mg was provided as rescue medication to be taken as required. The time when the rescue medication was administered was recorded on the case report form.|Within 24 hours of administration of study drug|ITT Population.|||Hours||Full Range|Median
2832696|NCT00281684|Secondary|Change From Baseline in the Pain Intensity Based on the VAS up to 10 Hours Post-Baseline|Pain intensity was assessed using VAS. The VAS was a subjective assessment of post-operative pain intensity. The participants rated the pain intensity at the time of the assessment by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left (0 mm) indicated no pain and extreme right (100 mm) indicated worst pain imaginable. This scale has no subscales. The Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) to 10 hours post Baseline|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2832697|NCT00281684|Secondary|Change From Baseline in the Pain Intensity Based on the Verbal Rating Scale (VRS) up to 10 Hours Post Baseline|Pain intensity was assessed using VRS. Participants also used a 4-point categorical VRS for the subjective assessment of postoperative pain. The score and it corresponding intensity was such that 0= no pain, 1= mild, 2= moderate and 3= severe. The VRS was collected as an independent measure of the participant's pain and was not prospectively correlated to the study participant's numerical score (number of millimeters) on the VAS. Participants were provided with a worksheet with a list of adjectives to read and they were asked to select the word by checking the box that best described their level of pain. The number associated with the adjective chosen by the participant constituted the pain intensity. Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to 10 hours post Baseline (Day 1)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2832698|NCT00281684|Primary|Mean of Pain Intensity Based on the Visual Analogue Scale (VAS)|Pain intensity was assessed using VAS. These assessments were then summarized to give a weighted mean score. The VAS was a subjective assessment of post-operative pain intensity. The participants rated the pain intensity at the time of assessment by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left (0 mm) indicated no pain and extreme right (100 mm) indicated worst pain imaginable. This scale has no subscales. Only those participants available at the specified time points were analyzed.|Up to 10 hours post-dose|The Intent-to-Treat (ITT) population which comprised of all participants randomized to treatment, who took the study medication and who had at least one post-dose assessment. The ITT population did not include participants who took rescue medication or withdrew within the first 120 minutes after administration of study medication.|||Scores on a Scale||Standard Deviation|Least Squares Mean
2832699|NCT00281658|Secondary|Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|The original outcome measure to be analyzed was time to response; however, data are presented as the number of participants with a response at each nominal visit. Responses are based on the investigator's assessment, and only participants with a confirmed CR or PR were included in this analysis.|Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|Participants in the ITT Population with a confirmed CR or PR|||participants|||Number
2832700|NCT00281658|Secondary|Duration of Response|Duration of response is defined for the subset of participants with a confirmed CR or PR as the time from first documented evidence of CR or PR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause during the randomized phase. Only participants with a confirmed CR or PR were included in this analysis. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|Participants in the ITT Population with a confirmed CR or PR|||months||95% Confidence Interval|Median
2832701|NCT00281658|Secondary|Clinical Benefit|Clinical benefit is defined as the number of participants achieving either a confirmed CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions], taking as reference the smallest sum LD since treatment start) of >=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population|||participants|||Number
2833025|NCT00278889|Secondary|QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
2832702|NCT00281658|Secondary|Overall Response (OR)|OR, evaluated per Response Evaluation Criteria in Solid Tumors (RECIST), is defined as the number of participants achieving either a confirmed complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) of tumor, which were based on confirmed responses from the investigator assessment of best OR during the randomized phase. Participants with unknown or missing responses were treated as non-responders.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population|||participants|||Number
2832703|NCT00281658|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization until the earliest date of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population|||months||95% Confidence Interval|Median
2832704|NCT00281658|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization to death (up to maximum of Month 53)|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
2832705|NCT00281632|Secondary|Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
2832706|NCT00281632|Secondary|Mean Change From Baseline to Response in Hemoglobin and Hematocrit|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.|||g/L||Standard Deviation|Mean
2832707|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroid Stimulating Hormone|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||milliunits per liter (MU/L)||Standard Deviation|Mean
2832708|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroxine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||nanomoles per liter (nmol/l)||Standard Deviation|Mean
2832709|NCT00281632|Secondary|Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||millimoles per liter (mmol/l)||Standard Deviation|Mean
2832710|NCT00281632|Secondary|Mean Change From Baseline to Response in Total Bilirubin and Creatinine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||micromoles per liter (umol/l)||Standard Deviation|Mean
2832711|NCT00281632|Secondary|Mean Change From Baseline to Response in Amylase and Lipase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||Units per liter (U/L)||Standard Deviation|Mean
2832712|NCT00281632|Secondary|Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||International Units per liter (IU/L)||Standard Deviation|Mean
2832713|NCT00281632|Secondary|Mean Change From Baseline to Response in Albumin|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.|||grams per liter (g/L)||Standard Deviation|Mean
2832714|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate|Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.|Baseline to response (up to 3 years)|All participants|||participants|||Number
2832715|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure|Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.|||participants|||Number
2832716|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure|Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.|||participants|||Number
2832717|NCT00281632|Secondary|Overall Tumor Response|Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.|Baseline to response (up to 3 years)|All participants|||participants|||Number
2832801|NCT00281099|Secondary|Composite Mitral Regurgitation (MR) Severity Score|"Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of None to Trivial to Grade IV, with Grade IV being the worst possible score and None to Trivial being the best possible score."|Baseline, 12, and 24 month visits||||participants|||Number
2832718|NCT00281632|Secondary|Median Progression-free Survival (PFS)|Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)|All participants with PFS|||days||95% Confidence Interval|Median
2832719|NCT00281632|Secondary|Overall Response and Stable Disease (SD)|Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.|Baseline to response (up to 3 years)|All participants|||percentage of participants|||Number
2832720|NCT00281632|Secondary|CA-125 Doubling Time Prior to and During Treatment With Pazopanib|CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.|Baseline to doubling of CA-125 (up to 3 years)|All participants with confirmed CA-125 50% reduction||||||
2832721|NCT00281632|Secondary|Duration of Biochemical Response (CA-125)|Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction|||days||95% Confidence Interval|Median
2832722|NCT00281632|Secondary|Time to Biochemical Response (CA-125)|Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction|||days||Full Range|Median
2832723|NCT00281632|Primary|Best Biochemical Response (Cancer Antigen [CA-125])|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.|Baseline to response (up to 3 years)|All participants|||percentage of participants|||Number
2832724|NCT00281580|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)|Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|8 weeks|Treated set|||percentage of participants|||Number
2832725|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough pulse rate measurements included all treated patients that had at least one in-clinic pulse rate measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||bpm||Standard Deviation|Mean
2832726|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
2832727|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
2832728|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832729|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832730|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832731|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies"|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
2832907|NCT00279708|Secondary|Pulmonary Function Tests|Spirometry measurements (FVC and FEV1) obtained post-bronchodilator Diffusion, adjusted for hemoglobin|12 month treatment period||2017-09-30|09/2017||||
2832733|NCT00281580|Other Pre-specified|BP Control|Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||percentage of participants|||Number
2832734|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
2832735|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||percentage of participants|||Number
2832736|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
2832737|NCT00281580|Other Pre-specified|Change From Baseline in Seated Trough Cuff DBP|Observed results for mod-sev patients - key combination therapies|Nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
2832738|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
2832739|NCT00281580|Secondary|Change From Baseline in Seated Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
2832740|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for all patients - key combination therapies|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff Pulse Rate measurements included all treated patients that had at least one Pulse Rate measurement following treatment with target therapy (FAS-TC)|||bpm||Standard Deviation|Mean
2832741|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as moderate or severe hypertension at baseline (FAS-TC-MS), excluding patients treated with placebo|||mmHg||Standard Error|Least Squares Mean
2832742|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
2832743|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Deviation|Mean
2832744|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Error|Least Squares Mean
2832745|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)|||mmHg||Standard Deviation|Mean
2834512|NCT00262119|Secondary|Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism||2 years|||||||
2832746|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Error|Least Squares Mean
2832747|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).|||mmHg||Standard Deviation|Mean
2832748|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Deviation|Mean
2832749|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Deviation|Mean
2832750|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832751|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832752|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832753|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.|||mmHg||Standard Deviation|Mean
2832754|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies"|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
2832755|NCT00281580|Other Pre-specified|BP Control|Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy (FAS-TC).|||percentage of participants|||Number
2832756|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
2832757|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
2832758|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||percentage of participants|||Number
2832759|NCT00281580|Other Pre-specified|Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP|Observed results for key combination therapies|Baseline to nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
2832760|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Error|Least Squares Mean
2834513|NCT00262119|Secondary|Development of Atrioventricular (AV) Block and Pacemaker Dependency||2 years|||||||
2834514|NCT00262119|Secondary|Adverse Events||2 years|||||||
2832761|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Error|Least Squares Mean
2832762|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)|||mmHg||Standard Error|Least Squares Mean
2832763|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo|||mmHg||Standard Error|Least Squares Mean
2832764|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Error|Least Squares Mean
2832765|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
2832766|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Error|Least Squares Mean
2832767|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
2832768|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Error|Least Squares Mean
2832769|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).|||mmHg||Standard Deviation|Mean
2832770|NCT00281528|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|up to 56 months|Treated population|||months||95% Confidence Interval|Median
2832771|NCT00281528|Primary|The Number of Participants With a Dose Interruption of ABI-007|Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population|||Participants|||Number
2832772|NCT00281528|Primary|The Number of Participants With at Least One Dose Delay for ABI-007|Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician's discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population|||Participants|||Number
2832773|NCT00281528|Primary|The Number of Participants With at Least One Dose Reduction for ABI-007|Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population|||Participants|||Number
2832787|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin|Cmin defined as pre-dose concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2832774|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100g/L; Grade 2 = <100 - 80g/L; Grade 3 = <80 - 65g/L; Grade 4 = <65g/L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
2832775|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
2832776|NCT00281528|Primary|Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal -3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
2832777|NCT00281528|Secondary|Kaplan Meier Estimate for Participant Survival|Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.|Up to 56 months|Treated population|||Months||95% Confidence Interval|Median
2832778|NCT00281528|Secondary|Kaplan Meier Estimate for Duration of Response|Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response|Up to 43 months (until progressed)|Treated population who achieved a complete or partial response|||Months||95% Confidence Interval|Median
2832779|NCT00281528|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to 43 months (until progressed)|Treated population|||Months||95% Confidence Interval|Median
2832780|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9L; Grade 2 = <1.5 - 1.0*10^9L; Grade 3 = <1.0 - 0.5*10^9L; Grade 4 = <0.5*10^9L"|up to 54 months|Treated population who had at least one post baseline value|||participants|||Number
2832781|NCT00281528|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|"Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either~A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or~A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or~Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease."|Up to 43 months (until progressed)|Treated population|||Percent of Total Participants|||Number
2832782|NCT00281528|Primary|The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Up to 43 months|Treated population|||Percent of Total Participants|||Number
2832783|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|PAPAW (.9 m/s, 10 W)|||VO2 (ml/min)||Standard Deviation|Mean
2832784|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|personal w/c (.9 m/s, 10 W)|||VO2 (ml/min)||Standard Deviation|Mean
2832785|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12|dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng*h/mL/mg||Standard Deviation|Mean
2832786|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12|AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng*h/mL||Standard Deviation|Mean
2834515|NCT00262119|Secondary|Persistent Atrial Fibrillation (AF)||2 years|||||||
2832788|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax|dn-Cmax is defined as dose normalized peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng/mL/mg||Standard Deviation|Mean
2832789|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax|Cmax defined as peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2832790|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax|Tmax defined as time to peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.|||hours||Full Range|Median
2832791|NCT00281320|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).|up to 30 days after study medication stop date|Per protocol|||participants|||Number
2832792|NCT00281320|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).|Up to Day 42 (treatment period)|Per protocol|||Participants|||Number
2832793|NCT00281099|Secondary|ICD-indicated Patients With Class I Pacemaker Indication.|Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant|Period of time prior to patient consent when considering patient for Implant/Enrollment|Centers kept a screening log, recording for each patient considered for new ICD implant and possible trial enrollment whether the patient had a Class I pacing indication at time of implant. The analysis consisted of descriptive statistics (counts of the 2051 screened patients).|||participants|||Number
2832794|NCT00281099|Secondary|All Cause Mortality|Death from any cause|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants who died|||Number
2832795|NCT00281099|Secondary|"Quality of Life (QOL) Score"|"Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life(QOL) Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.~Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)"|Baseline, 12, 24, and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Units on a scale||Standard Deviation|Mean
2832796|NCT00281099|Secondary|Percent Ventricular Pacing|The percentage of a patients' ventricular beats that were paced by the device.|Enrollment, 6, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Percent pacing||Standard Deviation|Mean
2832797|NCT00281099|Secondary|"Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction"|Whether a subject is on each of a pre-specified set of drugs or classes of drugs.|Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Percentage of Subjects|||Number
2832798|NCT00281099|Secondary|Development of a Pacing Indication During the Study|Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants|||Number
2832799|NCT00281099|Secondary|Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History|"Persistent AF was defined as any of the following:~2 consecutive visits in which the patient presents with AF~7 consecutive days of at least 22 hours per day of AT/AF~A cardioversion prior to 7 consecutive days of at least 22 hours per day of AT/AF~Clinically Important AF was defined as more than 20 hours of AT/AF in a single day"|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|1 of 1031 randomized subjects had a history of at least 6 months of chronic AF, which was an exclusion criterion. Of the remaining 1030 randomized subjects that met all inclusion criteria, only those with no history of AF were included in the analysis (445 in the VVI 40 arm and 444 in the MVP arm). An intention to treat analysis was performed.|||participants|||Number
2832800|NCT00281099|Secondary|"Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes"|Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Annualized Episodes per Patient Month|||Number
2834516|NCT00262119|Secondary|Atrial Fibrillation Burden||2 years|||||||
2832802|NCT00281099|Secondary|Left Atrial (LA) and Mitral Regurgitation (MR) Areas|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||centimeters squared (cm2)||Standard Deviation|Mean
2832803|NCT00281099|Secondary|Hemodynamic Deceleration Time|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||milliseconds (ms)||Standard Deviation|Mean
2832804|NCT00281099|Secondary|Hemodynamic Velocity Measures|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||meters per second (m/s)||Standard Deviation|Mean
2832805|NCT00281099|Secondary|Left Ventricular (LV) Sphericity Index|"Echocardiogram measures for each endpoint were obtained at multiple time points.~LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||Ratio||Standard Deviation|Mean
2832806|NCT00281099|Secondary|Left Ventricular (LV) and Left Atrial (LA) Volumes|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||milliliters (mL)||Standard Deviation|Mean
2832807|NCT00281099|Secondary|Left Ventricular (LV) Ejection Fraction and Fractional Shortening|"Echocardiogram measures for each endpoint were obtained at multiple time points.~LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.~LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||percentage of LV unit||Standard Deviation|Mean
2832808|NCT00281099|Secondary|Heart Chamber Dimensions and Wall Thicknesses|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||centimeters (cm)||Standard Deviation|Mean
2832809|NCT00281099|Secondary|Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time|NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.|Baseline, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants|||Number
2832810|NCT00281099|Secondary|Occurrence of Worsening Heart Failure-related Adverse Events|HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||participants/events|||Number
2832811|NCT00281099|Primary|"All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations."|A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF)|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."|||events|||Number
2832812|NCT00281021|Primary|Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.||Measured every 6 weeks after baseline until disease progression, an average of 3 months||||participants|||Number
2832813|NCT00280917|Secondary|Safety|Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs|12 weeks|||||||
2833026|NCT00278889|Secondary|QOL: Time to Worsening of Clear Cell Sarcoma (CCS)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
2832814|NCT00280917|Secondary|ACR Criteria Components|ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.|12 weeks|||||||
2832815|NCT00280917|Primary|ACR Efficacy Criteria|ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population|12 weeks||||participants|||Number
2832816|NCT00280904|Primary|Number of Subjects With Shunt Infections|Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.|Implantation to Explant||||participants|||Number
2832817|NCT00280904|Secondary|Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures||April 2008||||participants|||Number
2832818|NCT00280826|Secondary|Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks||||ETDRS letters||Standard Deviation|Mean
2832819|NCT00280826|Secondary|Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks|Analysis was per protocol|||ETDRS letters||Standard Deviation|Mean
2832820|NCT00280826|Secondary|Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT).|Better eye indicates the eye with better VA.|Baseline and 16 weeks|Analysis was per protocol|||microns||Standard Deviation|Mean
2832821|NCT00280826|Secondary|Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT).|Worse eye indicates the eye with the worst visual acuity (VA).|Baseline and 16 weeks|Analysis was per protocol|||microns||Standard Deviation|Mean
2832822|NCT00280826|Primary|Number of Participants With Systemic Toxicities, Adverse Events, or Infections|Safety outcomes were recorded by observing and tabulating the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Safety assessments were made by the investigators continuously during the study, with a review of the previous visit interval performed at each scheduled visit. Each participant was also encouraged to report any apparent adverse events between scheduled visits and could return for additional evaluations or treatment between scheduled visits if needed.|16 weeks|Analysis was per protocol|||Participants|||Number
2832823|NCT00280748|Secondary|Response of Patients With Extracranial Disease Treated With Pemetrexed|Response was measured by Response Evaluation Criteria In Solid Tumors RECIST criteria v1.0. Complete Response (CR) - Disappearance of all lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing nontarget lesions.|maximum 5 months|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.|||Participants|||Count of Participants
2832824|NCT00280748|Secondary|Neurological Function by Mini Mental State Examination|The Mini Mental State Examination is a 30-point questionnaire that is used to measure cognitive impairment. Score totals range from normal cognition (24-30 points), mild impairment (19-23 points), moderate impairment (10-18 points), to severe impairment (≤9 points).|Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment).|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limited sample size. The data represents the results of patients enrolled and treated on the trial.|||score on the scale||Full Range|Mean
2832825|NCT00280748|Secondary|Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification|"A classification score defined as follows:~Able to work or to perform normal activities: neurological findings minor or absent~Able to carry out normal activities with minimal difficulties. Neurological impairment does not require nursing care or hospitalization~Seriously limited in performing normal activities. Requiring nursing care or hospitalization. Patients confined to bed or wheelchair or have significant intellectual impairment~Unable to perform even minimal normal activities. Requiring hospitalization and constant nursing care and feeding. Patients unable to communicate or in coma.A higher score indicates worse function."|At Baseline, 30 days, and at end of treatment (maximum 5 months).|This study was terminated due to slow enrollment and the planned statistical analyses could not be performed due to limit sample size. The data represents the results of patients enrolled and treated on the trial.|||scores on a scale||Full Range|Mean
2832826|NCT00280748|Secondary|Evaluate the Functional Status of Patients Treated With This Regimen.|"Functional status evaluated using the Karnofsky functional status scale. The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death."|baseline functional status only||||Participants|||Count of Participants
2834153|NCT00265330|Primary|Mean Change From Baseline in Supine Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||beats per minute||Standard Deviation|Mean
2832827|NCT00280748|Secondary|Estimate the Overall Survival of Patients Treated With This Regimen.|Patients were followed for survival from start of treatment until death from any cause (up to 4 years)|4 years|Four patients were unevaluable due to extra-cranial disease progression or decline in performance status preventing re-evaluation.|||months||Full Range|Median
2832828|NCT00280748|Secondary|Number of Subjects Experiencing Adverse Events|"Toxicities was assessed using Common Terminology Criteria for Adverse Events (CTCAE) grading scale. Only toxicities with attribution to chemotherapy of definite or probable are considered, as determined by treating physician."|maximum 5 months|All patients who received treatment were evaluated|||Participants|||Count of Participants
2832829|NCT00280748|Primary|Response of Intracranial Metastases (Complete and Partial Response)|Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|126 days|Of the 10 patients, four patients were unevaluable due to extra-cranial disease progression or decline in performance status prevent re-evaluation.|||Participants|||Count of Participants
2832830|NCT00280735|Secondary|Overall Survival|Overall survival rate at 18 months.|The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months|Participants receiving treatment|||percentage of participants|||Number
2832831|NCT00280735|Secondary|Progression Free Survival|Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.|The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months|Participants receiving treatment|||percentage of participants|||Number
2832832|NCT00280735|Secondary|Toxicity in Patients Treated With This Regimen|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).|Day 1 of treatment to 30 days after treatment discontinuation|Patients receiving treatment|||percentage of participants|||Number
2832833|NCT00280735|Secondary|Patterns of Recurrence in Patients Treated With This Regimen|Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.|Up to 5 years||||Participants|||Count of Participants
2832834|NCT00280735|Primary|Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen|Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.|12 weeks from initiating adjuvant therapy|Patients assigned to treatment|||Participants|||Count of Participants
2832835|NCT00280683|Secondary|L-arginine Serum Concentration||90 days||||pmol/100ul||Standard Error|Mean
2832836|NCT00280683|Primary|Number of Asthma Exacerbations in Three Months|Asthma exacerbation is a composite endpoint. An asthma exacerbation is defined as any of the following: a) a drop in the morning peak expiratory flow rate (PEF) >30% from baseline on 2 consecutive days, b) a need for initiation of or increased dose of inhaled corticosteroids, or the c) doubling of short-acting rescue β-agonist drug use (e.g.Albuterol) on two consecutive days. Any one of these three counts as one asthma exacerbation.|3 months|Our original power analysis was based on an expected minor exacerbation rate of 3-4 per month.|||exacerbations|||Number
2832837|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832838|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832839|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832840|NCT00280566|Secondary|Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832841|NCT00280566|Secondary|Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period|Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.|Period 2: Weeks 1 - 24 or time of early termination|Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832925|NCT00279214|Secondary|Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index|Cardiac Index = cardiac output divided by body surface area.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.|||liters/minute/meters squared||Standard Deviation|Mean
2832842|NCT00280566|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.|Period 2: Weeks 1 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832843|NCT00280566|Secondary|Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period|Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.|||scores on scale||Standard Deviation|Mean
2832844|NCT00280566|Secondary|Modified Time to Intervention for a Mood Episode (TIME)|Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: Week 24 or time of early termination|Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode|||Days||Standard Error|Mean
2832845|NCT00280566|Secondary|Time to Discontinuation for Any Reason During Double Blind Period 2|Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively.|||days||Standard Error|Mean
2832846|NCT00280566|Primary|Time to Intervention for a Mood Episode During Double Blind Period|Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.|||Days||Standard Error|Mean
2832847|NCT00280397|Secondary|To Make Exploratory Analyses of Pharmacodynamic Markers||Every 3 weeks|||||||
2832848|NCT00280397|Secondary|Evaluate the Anti-tumor Activity of E7080||Every 3 weeks|||||||
2832849|NCT00280397|Secondary|Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile||Every 3 weeks|||||||
2832850|NCT00280397|Primary|DLT of E7080 Repeatedly Administered Twice a Day|DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.|||Participants with DLT|||Number
2832851|NCT00280397|Secondary|Number of Participants With Adverse Events / Serious Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.|All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.|||Participants|||Number
2832852|NCT00280397|Primary|Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day|The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.|||mg BID|||Number
2832853|NCT00280397|Secondary|To Elucidate the Pharmacokinetic Profile of E7080||Every 3 weeks|||||||
2832854|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline).|Baseline||||EDB M-Wave Area at Baseline (mVms)||Standard Deviation|Mean
2832855|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave area reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave area reduction from baseline were presented as a percentage.|Baseline and Up to 12 Weeks||||Percentage of Reduction||Standard Deviation|Mean
2834517|NCT00262119|Secondary|Any Hospitalization||2 years|||||||
2832856|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline).|Baseline||||EDB M-Wave Amplitude at Baseline (mV)||Standard Deviation|Mean
2832857|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave amplitude reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave amplitude reduction from baseline were presented as a percentage.|Baseline and Up to Week 12||||Percentage of Reduction||Standard Deviation|Mean
2832858|NCT00280293|Primary|Positive Urine Drug Screens|Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.|10 weeks||||percentage of participants|||Number
2832859|NCT00280293|Secondary|Dollars Spent|Dollars spent on cocaine during the 7 days of week 10, or at last assessment if participant withdrew early, based on self report.|10 weeks||||Dollars||Standard Deviation|Mean
2832860|NCT00280293|Secondary|Depression Score on the Hamilton Rating Scale For Depression|Total score on the Hamilton Rating Scale for Depression at week 10 visit or at last assessment if participant withdrew early(total score values range 0 - 52. A higher score indicates more severe depression.|10 weeks||||units on a scale||Standard Deviation|Mean
2832861|NCT00280293|Primary|Days of Cocaine Use|Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.|10 weeks||||days||Standard Deviation|Mean
2832862|NCT00280241|Secondary|Duration of Response|The length of time for which the complete response is maintained.|From complete response to the time of progressive disease, death or last clinical examination||||Months||Full Range|Median
2832863|NCT00280241|Primary|Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience a complete clinical response.|Three months after the sixth cycle (9 months)||||participants|||Number
2832864|NCT00280241|Secondary|Overall Survival Rate|The percentage of participants who are still alive.|Five years after starting rituximab, cyclophosphamide and fludarabine||||percentage of participants||95% Confidence Interval|Number
2832865|NCT00280241|Primary|Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience any grade 3-5 toxicity.|Duration of treatment on study||||participants|||Number
2832866|NCT00280150|Secondary|Feasibility and Tolerability of Administering Consolidation Therapy|The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy|6 cycles|Of the initial 14 patients, only 9 (64%) patients were able to start consolidation therapy and only 5 (36%) patients were able to complete 6 cycles.|||Participants|||Count of Participants
2832867|NCT00280150|Secondary|Overall Response Rate and Survival Profile|The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression.|5 years|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.|||percentage of participants||95% Confidence Interval|Number
2832868|NCT00280150|Secondary|Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)|"Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up.~Complete Response (CR)- Disappearance of all target lesions"|5 years|43 of 45 patients received both cycles of induction C/P therapy plus bevacizumab.|||Participants|||Count of Participants
2832869|NCT00280150|Secondary|Progression-free Survival (PFS)|The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.|||Months||95% Confidence Interval|Median
2832870|NCT00280150|Primary|Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy|A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0).|6 weeks after completion of therapy|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable for toxicity. 42 patients were eligible for concurrent therapy.|||percentage of participants|||Number
2832871|NCT00280150|Primary|Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])|Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter.|6 weeks after completion of therapy|This was a phase I objective only, so the phase II participants are not included.|||DLTs|||Number
2832926|NCT00279214|Secondary|Mean Arterial Pressure||baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.|||mm Hg||Standard Deviation|Mean
2832872|NCT00280059|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.|Week 8, Week 32, and Week 56|FAS|||participants|||Number
2832873|NCT00280059|Secondary|Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment.|Baseline to Week 56|FAS; N = number of participants with a HADS measurement at baseline and Week 56.|||scores on scale||Standard Error|Least Squares Mean
2832874|NCT00280059|Secondary|Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group|Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.|Week 5 up to Week 56|FAS; N = number of participants with analyzable data.|||percentage of participants|||Number
2832875|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||28-day seizure rate||Standard Deviation|Mean
2832876|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
2832877|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||28-day seizure rate||Standard Deviation|Mean
2832878|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
2832879|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Mean
2832880|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
2832881|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Mean
2832882|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.|||seizures/28 days||Standard Deviation|Median
2834518|NCT00262119|Secondary|Cardiovascular Death||2 years|||||||
2832883|NCT00280059|Secondary|Time to First Seizure After the 4-Week Dose Escalation Phase|Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.|||days||95% Confidence Interval|Median
2832884|NCT00280059|Secondary|Exit Due to Any Reason After 4-week Dose Escalation Phase|Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.|||participants|||Number
2832885|NCT00280059|Secondary|Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase|Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500.|||participants|||Number
2832886|NCT00280059|Secondary|Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.|||participants|||Number
2832887|NCT00280059|Secondary|Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500.|||participants|||Number
2832888|NCT00280059|Secondary|Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures|Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.|||days||95% Confidence Interval|Median
2832889|NCT00280059|Primary|Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase|Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.|Week 5 up to Week 56|Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study.|||percentage of participants|||Number
2832890|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)|"Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the Follow-up Period from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion."|6 month to the 12 month visit||||participants|||Number
2832891|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)|"Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the Follow-up Period from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event."|6 month to the 12 month visit||||participants|||Number
2832892|NCT00279955|Primary|Occurrence of Heart Failure (HF) Related Adverse Event (AE)|"Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the Follow-up Period from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body."|From 6 month to the 12 month visit|Of the 1001 subjects meeting inclusion and exclusion criteria, 643 subjects had been followed longer than 6 months and had the OptiVolTM feature save-to-disk data available. Those 643 subjects were included in this analysis.|||participants|||Number
2833027|NCT00278889|Secondary|QOL: Time to Worsening of Treatment-free Survival (TFS)|Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
2832893|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
2832894|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
2832895|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
2832896|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
2832897|NCT00279916|Secondary|Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears|As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.|baseline, 6 weeks|Number of participants is based on those who completed the study and who completed a baseline and a follow-up questionnaire. 38 of the subjects randomized to Triamcinolone acetonide nasal spray and 40 of the subjects randomized to placebo had a baseline and follow-up questionnaire at 6 weeks.|||participants|||Number
2832898|NCT00279916|Secondary|Per-Ear Treatment Outcome|Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.|baseline, 6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.|||ears|||Number
2832899|NCT00279916|Secondary|Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution|For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination.|6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.|||participants|||Number
2832900|NCT00279916|Primary|Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment|Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.|6 weeks|Number of participants is based on those who completed the study and who had a follow-up tympanogram. 37 of the subjects randomized to Triamcinolone acetonide nasal spray and 37 of the subjects randomized to placebo had a follow-up tympanogram at 6 weeks.|||participants|||Number
2832901|NCT00279812|Secondary|Selenoproteins and Se-biomarkers|Plasma selenoprotein P after the supllementation|10 weeks|Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject|||ug/mL||Standard Deviation|Mean
2832902|NCT00279812|Secondary|Selenium Status|Plasma selenium concentration after supplementation|10 weeks|Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject|||ng/mL||Standard Deviation|Mean
2832903|NCT00279812|Primary|Cellular and Humoral Immune Response|Total glutathione peroxidase 1 activity in platelets after supplementation|12 weeks|Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject|||umol/min||Standard Deviation|Mean
2832904|NCT00279708|Other Pre-specified|Chest Imaging|HRCT Chest radiographs|12 month treatment period||2018-09-30|09/2018||||
2832905|NCT00279708|Secondary|Quality of Life and Dyspnea Scales|St. George's Respiratory Questionnaire SF-36 Modified MRC Dyspnea Scale|12 month treatment period||2017-09-30|09/2017||||
2832906|NCT00279708|Secondary|Exercise Performance|Cardiopulmonary Exercise Tests (VO2 peak, VO2/work, VECO2) Six minute Walk Test (distance, Borg scale)|12 month treatment period||2017-09-30|09/2017||||
2832908|NCT00279708|Secondary|Pulmonary Sarcoidosis Flares|Flare rates and relative risk: Flares (relapses) were defined as the physiological deterioration in pulmonary function due to worsened pulmonary inflammation. The criteria used for a pulmonary flare included: > 15% decline in static function (FEV1 post, FVC post); or (> 20% DLCO adj); or a > 15% decline in walk distance as measured by the six minute walk test, or via a decline in oxygen consumption collected during a cardiopulmonary exercise test (CPET). Additional factors considered included an increase in dyspnea (>15% increase in the dyspnea scale (TDI); and/or significant radiographic worsening. Clinical assessment of the patient's status may have been factored into the criteria for flare determination as well.|1 year||2017-09-30|09/2017||||
2832909|NCT00279708|Primary|The Steroid Sparing Period|The duration of steroid sparing was defined as the date when the target dose of prednisone was reached until the date at which the dose was increased and/or met the relapse (flare) criteria; or until the 12 month study phase ended if no prednisone dose increase was required. The steroid sparing period was measured in units of days. The prednisone target dose was defined as a 90% reduction of the baseline dose or an absolute prednisone dose of 4 mg/day or less.|1 year||||days||Inter-Quartile Range|Mean
2832910|NCT00279591|Secondary|Amount of Intravenous Fluid Resuscitation||At start of inter-facility transport, then every 15 minutes until arrival.||||ml/kg||Standard Deviation|Mean
2832911|NCT00279591|Secondary|Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.|The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness.|Up to two weeks|This is the total number of participants analyzed for the intervention group and the control group and the total number of days analyzed overall for the intervention group and the control group.|||units on a scale|Participants|Standard Deviation|Mean
2832912|NCT00279591|Secondary|Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure.|Total number of organ failure days is for each group as a whole.|Up to two weeks|ITT|||Days|Participants||Number
2832913|NCT00279591|Secondary|Intensive Care Unit (ICU) Length of Stay||Up to two weeks||||days||Standard Deviation|Mean
2832914|NCT00279591|Primary|The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care|This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall.|Up to two weeks|Intention to Treat|||days||Standard Deviation|Mean
2832915|NCT00279500|Primary|Number of Adverse Events From 2 Weeks Post-op Until the End of the Study|All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.|From 2 weeks post-op until end of device usage, up to 10 years.||||total number of AEs|||Number
2832916|NCT00279305|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year|"The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.~The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."|When all participants complete the 1 year visit||||pmol per mL||95% Confidence Interval|Mean
2832917|NCT00279214|Secondary|Mixed Venous Oxygen Saturation|Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.|||percent saturation mixed venous oxygen||Standard Deviation|Mean
2832918|NCT00279214|Other Pre-specified|Number of Participants With Bleeding Events|Serious bleeding event resulted in one of following outcomes, or was significant for any reason: initial/ prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly/birth defect. Intracranial hemorrhage was also considered serious bleeding event.|baseline to 7 days|All enrolled patients|||participants|||Number
2832919|NCT00279214|Secondary|Endogenous Protein C Level||Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.|||percentage of Protein C activity||Standard Deviation|Mean
2832920|NCT00279214|Secondary|7 Day All-cause In-hospital Mortality||baseline to 7 days|All enrolled patients|||partipants|||Number
2832921|NCT00279214|Secondary|Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours|CrCl = (urine creatinine*urine volume)/(plasma creatinine*time period of urine collection). Corrected CrCl = CrCl*1.73/body surface area. Change in CrCl = Endpoint minus baseline.|Baseline and 24 hours|Number of per-protocol participants with values at baseline and 24 hours.|||milliliter per minute||Standard Deviation|Mean
2832922|NCT00279214|Secondary|Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).|Baseline and 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.|||units on a scale||Standard Deviation|Mean
2832923|NCT00279214|Secondary|Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)|Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).|Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.|||units on a scale||Standard Deviation|Mean
2832924|NCT00279214|Secondary|Lactate Level|Measures of global tissue perfusion and oxygenation were assessed via lactate levels.|Baseline to 6 Hours|Number of per-protocol participants with values at baseline and 6 hours.|||millimoles per Liter||Standard Deviation|Mean
2834519|NCT00262119|Secondary|Cumulative Percentage of Ventricular Pacing||2 years|||||||
2832927|NCT00279214|Secondary|Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|Baseline, 96 hours|Number of per-protocol participants with values at baseline and 96 hours.|||units on a scale||Standard Deviation|Mean
2832928|NCT00279214|Primary|Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.|||units on a scale||Standard Deviation|Mean
2832929|NCT00279201|Secondary|ADDENDUM: HbA1c at Specified Visits and Endpoint||Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832930|NCT00279201|Secondary|ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24||Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||ug/mL||Standard Deviation|Mean
2832931|NCT00279201|Secondary|ADDENDUM: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||episodes/participant/year||Standard Deviation|Mean
2832932|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percentage of participants|||Number
2832933|NCT00279201|Secondary|ADDENDUM: Insulin Dose||Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||units/kg/day||Standard Deviation|Mean
2832934|NCT00279201|Secondary|ADDENDUM: Body Weight||Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||kilograms||Standard Deviation|Mean
2832935|NCT00279201|Secondary|ADDENDUM: Incremental Change From Baseline in Body Weight||Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||kilograms||Standard Deviation|Mean
2832936|NCT00279201|Secondary|ADDENDUM: 7-point SMPG Profiles|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||mg/dL||Standard Deviation|Mean
2832937|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%||Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percent of participants|||Number
2832938|NCT00279201|Secondary|ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint||Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.|||percent||Standard Deviation|Mean
2832939|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||mg/dL||Standard Deviation|Mean
2832963|NCT00279201|Secondary|MAINTENANCE: HbA1c at Specified Visits and Endpoint||Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2834154|NCT00265330|Primary|Mean Change From Baseline in Supine Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||millimeters mercury (mm Hg)||Standard Deviation|Mean
2832940|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||mg/dL||Standard Deviation|Mean
2832941|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||ug/ml||Standard Deviation|Mean
2832942|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||ug/mL||Standard Deviation|Mean
2832943|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
2832944|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
2832945|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
2832946|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
2832947|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832948|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832949|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
2832950|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||participants|||Number
2832951|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||years||Standard Deviation|Mean
2832952|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||years||Standard Deviation|Mean
2832953|NCT00279201|Secondary|MAINTENANCE: Change From Baseline to Endpoint in HbA1c||Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832954|NCT00279201|Secondary|MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol||Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||ug/dL||Standard Deviation|Mean
2832955|NCT00279201|Secondary|MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||episodes/participant/year||Standard Deviation|Mean
2832956|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percentage of participants|||Number
2832957|NCT00279201|Secondary|MAINTENANCE: Insulin Dose||Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||units/kg/day||Standard Deviation|Mean
2832958|NCT00279201|Secondary|MAINTENANCE: Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||kilograms||Standard Deviation|Mean
2832959|NCT00279201|Secondary|MAINTENANCE: Incremental Change From Baseline in Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||kilograms||Standard Deviation|Mean
2832960|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%||Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||percentage of participants|||Number
2832961|NCT00279201|Secondary|MAINTENANCE: Rate of Increase in HbA1c|Rate of increase: HbA1c change/time period (month).|Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||HbA1c percent increase per month||Standard Deviation|Mean
2832962|NCT00279201|Secondary|MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||mg/dL||Standard Deviation|Mean
2834520|NCT00262119|Secondary|Heart Failure Medications||2 years|||||||
2834521|NCT00262119|Secondary|Subjects' Symptoms||2 years|||||||
2832964|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline|Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||participants|||Number
2832965|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose|Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2832966|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG|Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
2832967|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group|Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||participants|||Number
2832968|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c|Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832969|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||units on a scale||Standard Deviation|Mean
2832970|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin|Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||participants|||Number
2832971|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age|Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||years||Standard Deviation|Mean
2832972|NCT00279201|Secondary|INITIATION: Insulin Dose||Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||units/kg/day||Standard Deviation|Mean
2832973|NCT00279201|Secondary|INITIATION: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||Episodes/participant/year||Standard Deviation|Mean
2832974|NCT00279201|Secondary|INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percentage of participants|||Number
2832975|NCT00279201|Secondary|INITIATION: Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||kilograms||Standard Deviation|Mean
2834522|NCT00262119|Secondary|Burden of Composite Clinical Endpoint||2 years|||||||
2832976|NCT00279201|Secondary|INITIATION: Incremental Change From Baseline in Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||kilograms (kg)||Standard Deviation|Mean
2832977|NCT00279201|Secondary|INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)||Baseline (Initiation), Endpoint (Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
2832978|NCT00279201|Secondary|INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (LOCF) (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||milligrams per 100 Milliliters (mg/dL)||Standard Deviation|Mean
2832979|NCT00279201|Secondary|INITIATION: HbA1c||Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832980|NCT00279201|Secondary|INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percentage of participants|||Number
2832981|NCT00279201|Secondary|INITIATION: Change in HbA1c From Baseline to 24 Weeks||Baseline (Initiation) to Endpoint (LOCF, Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832982|NCT00279201|Primary|ADDENDUM: 24-Week Endpoint HbA1c|HbA1c at 24-week endpoint in Intensification Addendum of the trial.|Endpoint (Addendum) (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832983|NCT00279201|Primary|MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)|HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%|Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)|Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.|||months||95% Confidence Interval|Median
2832984|NCT00279201|Primary|INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2832985|NCT00278993|Secondary|Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|12 months|Per Protocol Population|||Percentage of Participants|||Number
2832986|NCT00278993|Secondary|Overall Survival||12 months|Intent to Treat Population|||Days||Full Range|Median
2832987|NCT00278993|Secondary|Progression Free Survival|From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.|12 months|Per Protocol Population|||Days||Full Range|Median
2832988|NCT00278993|Secondary|Duration of Prostate Specific Antigen Response Based on Bubley Criteria|Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir.|12 months.|Per Protocol Population|||Days||Full Range|Median
2832989|NCT00278993|Primary|Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.|12 months|Per Protocol Population|||Percentage of Participants|||Number
2832990|NCT00278954|Secondary|The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days||||Days||Standard Deviation|Mean
2832991|NCT00278954|Secondary|The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.|||dL/kg||Standard Deviation|Mean
2832992|NCT00278954|Secondary|The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.|||mL/day/kg||Standard Deviation|Mean
2840009|NCT00180713|Secondary|Change in 6-minute Walk Distance|Change in distance achieved in 6 minute walk test from baseline|6 months||||metres||Standard Deviation|Mean
2832993|NCT00278954|Secondary|The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.|||Days||Standard Deviation|Mean
2832994|NCT00278954|Primary|Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease.|By assessing the number of serious, acute, bacterial infections per subject per year in subjects with Primary Immunodeficiency disease.|12 months|Intent to Treat (ITT).|||SABIs/subject/year|||Number
2832995|NCT00278915|Secondary|Percentage of Patients With Gsα Mutation.|McCune-Albright Syndrome(MAS) is caused by an activating mutation in the gene coding for the stimulatory subunit of the G protein, Gsα. The altered Gsα causes autonomous activation of G-protein stimulated cAMP formation, which in the gonads, results in episodic uncontrolled sex steroid production and subsequent pubertal development. For patients who provided separate specific informed consent, the percentage of patients with a Gsα mutation at screening was assessed by molecular analysis.|Screening assessment (baseline)||||Percentage of participants|||Number
2832996|NCT00278915|Secondary|Change in Predicted Adult Height (PAH) From Baseline to Month 12.|Change in PAH from baseline to Month 12/final visit for patients equal to or over 6 years of age.|6 month pre-treatment observation period (result at Screening considered as baseline) followed by 12 month treatment period (on treatment period).||||cm||Standard Deviation|Mean
2832997|NCT00278915|Secondary|Change in Pubic Tanner Stage From Baseline to Month 12.|Change in pubic Tanner stage from baseline to Month 12/last visit. Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).||||units on a scale||Full Range|Median
2832998|NCT00278915|Secondary|Change in Breast Tanner Stage From Baseline to Month 12.|Change in breast Tanner stage from baseline to Month 12/last visit. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).||||units on a scale||Full Range|Median
2832999|NCT00278915|Secondary|PK: Mean Volume of Distribution (V2/F) .|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V2/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.||||Litres||Standard Error|Mean
2833000|NCT00278915|Secondary|PK: Mean Volume of Distribution (V1/F)|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V1/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.||||Litres||Standard Error|Mean
2833001|NCT00278915|Secondary|PK: Mean Clearance.|Mean clearance is the average amount of Fulvestrant which is eliminated|Throughout the 12 month treatment period.||||Litres/hour||Standard Deviation|Mean
2833002|NCT00278915|Secondary|Hormone Assays: Testosterone.|Hormone assays: testosterone at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.||||nmol/Litres||Standard Deviation|Mean
2833003|NCT00278915|Secondary|Hormone Assays: Follicle-stimulating Hormone (FSH).|Hormone assays: follicle-stimulating hormone (FSH)at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.||||IU/Litres||Standard Deviation|Mean
2833004|NCT00278915|Secondary|Hormone Assays: Luteinizing Hormone (LH).|Hormone assays: Luteinizing hormone (LH) at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.||||IU/Litres||Standard Deviation|Mean
2833005|NCT00278915|Secondary|Hormone Assays: Serum Oestradiol.|Hormone assays: serum oestradiol at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.||||pmol/Litres||Standard Deviation|Mean
2833006|NCT00278915|Secondary|Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.||||cm^3||Full Range|Median
2833007|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.||||cm^3||Full Range|Median
2833008|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.||||cm^3||Full Range|Median
2833009|NCT00278915|Secondary|Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Month 6 and Month 12 during the treatment period.||||cm^3||Full Range|Median
2833010|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 6 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 6 during the treatment period.||||cm^3||Full Range|Median
2833011|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 12 during the treatment period.||||cm^3||Full Range|Median
2833102|NCT00276861|Secondary|Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment|Number of months from time of enrollment to the date of first documented progression or date of death.|6 months||||months||95% Confidence Interval|Number
2833012|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the full 12 month treatment period. Z-score is [(growth velocity from the previous visit to the current visit - mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||Z-Score||Standard Deviation|Mean
2833013|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the second 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit - mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||Z-score||Standard Deviation|Mean
2833014|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.|Change from pre-treatment period to the first 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit - mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)||||Z-Score||Standard Deviation|Mean
2833015|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the full 12 month treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
2833016|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the second 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
2833017|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.|Change in growth velocity (annualised growth velocity.i.e. cm/y) from the pre treatment period to the first 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
2833018|NCT00278915|Secondary|Change in Bone Age Advancement Over the Whole 12 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the full 12 month treatment period. (Using last value carried forward method for the one patient who withdrew soon after their month 6 bone scan) Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||cm/year||Standard Deviation|Mean
2833019|NCT00278915|Secondary|Change in Bone Age Advancement Over the Second 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the second 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to second 6 months of the treatment period.||||cm/year||Standard Deviation|Mean
2833020|NCT00278915|Secondary|Change in Bone Age Advancement Over the First 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the first 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to first 6 months of the treatment period||||cm/year||Standard Deviation|Mean
2833021|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for the full 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||Percentage of Participants|||Number
2833022|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for at least 180 consecutive days during the 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|This particular protocolled endpoint does not relate to all patients but only those who had baseline vaginal bleeding - N=23 rather than N=30.|||Percentage of Participants|||Number
2833023|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥50% Reduction in the Number of Vaginal Bleeding Days|Percentage of participants with baseline vaginal bleeding who experienced ≥50% reduction in the number of vaginal bleeding days during the 12 month treatment period compared to the 6 month baseline period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|Number of participants (23) = number of eligible participants who have had bleeding during the 6 month baseline period|||Percentage of Participants|||Number
2833024|NCT00278915|Primary|Change in the Frequency of Annualised Days of Vaginal Bleeding|Change in the frequency of annualised days of vaginal bleeding during the 12 month treatment period compared to the 6 month baseline period, based on a worst-case scenario calculation .i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)||||days per year||Full Range|Median
2842382|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48||||L||Standard Error|Mean
2833028|NCT00278889|Secondary|Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)|Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007||||Days||Inter-Quartile Range|Median
2833029|NCT00278889|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation to data cut-off date of 30 January 2009||||Months||Inter-Quartile Range|Median
2833030|NCT00278889|Secondary|Objective Response Rate|"Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST."|Randomisation to data cut-off date of November 2007||||Participants|||Number
2833031|NCT00278889|Primary|Progression Free Survival|Number of months from randomisation to the earlier date of objective progression or death|Randomisation to data cut-off date of November 2007||||Months||Inter-Quartile Range|Median
2833032|NCT00278876|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib|Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.||||participants|||Number
2833033|NCT00278876|Secondary|2-year Overall Survival Rate||2 years||||percentage of participants|||Number
2833034|NCT00278876|Primary|2-year Relapse Free Survival Rate||2 years||||percentage of participants|||Number
2833035|NCT00278863|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years|Up to 2 years||||participants|||Number
2833036|NCT00278863|Primary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~Response rate is defined as the proportion of patients who showed OR."|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2833037|NCT00278655|Secondary|Survival|"Data are reporting the number of participants who survived three years after the transplant~Survival of 21 participants was evaluated at three years after the transplant"|three years||||participants|||Number
2833038|NCT00278655|Primary|Disease Progression|Data are reporting number of participants with disease progression. Disease progression is defined as a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least 3 months apart.|3 years after transplant||||participants|||Number
2833039|NCT00278564|Primary|Survival|Survival|up to 5 years|All participants who underwent stem cell transplantation|||Participants|||Count of Participants
2833040|NCT00278538|Primary|Survival|The primary efficacy outcome is overall survival.|6 months, then yearly x 5 years after transplant|"The # analyzed at 6 mos.- 4 years differs from the overall participant # analyzed because 2 participants were declined HSCT due to comorbidities and 2 died within 6 mos. after HSCT unrelated to the treatment. The # analyzed at 5 years differs from the overall participants analyzed due to an unrelated treatment death at 4 years after HSCT.~."|||Participants|||Count of Participants
2833041|NCT00278525|Primary|Disease Improvement|"Data are reporting number of participants that were classified as disease improvement.~Definition of disease improvement:~Disease improvement defined by at least 25% improvement in skin score (Rodnan), or 10% improvement in pulmonary function tests [diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA), or forced vital capacity (FVC)], or in cardiac tests [pulmonary artery (PA) systolic pressure by right heart cath] that persists > 6 months or ability to wean off total parenteral nutrition (TPN)"|12 months||||participants|||Number
2833042|NCT00278525|Primary|Time to Treatment Failure|"-Data are reporting number of participants that were classified as treatment failures~Time to Treatment Failure Definition-Treatment failure will not occur until a minimum of 12 months after enrollment at which time failure is defined as:~Failure of skin score (if > 14 on enrollment) to improve or increase in skin score by a 25% above lowest post treatment value and must be documented on 2 occasion 6 months apart~Deterioration in diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA) or forced vital capacity (FVC) by 10% below enrollment level or 10% below best post treatment value, due to systemic sclerosis, and documented on 2 occasion 6 months apart~Renal failure due to systemic sclerosis and defined as chronic dialysis for more than 12 months~Gastrointestinal failure due to systemic sclerosis and defined as initiation of total parenteral nutrition(TPN) for more than 12 months"|12 months|All participants were included|||participants|||Number
2833043|NCT00278512|Primary|Survival|Survival|Up to 5 years||||Participants|||Count of Participants
2833044|NCT00278473|Secondary|Rosenberg Self-Esteem Inventory|Mean change in Rosenberg Self-Esteem Inventory score at 12 weeks as compared to baseline. The scale is a ten item Likert scale, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
2833045|NCT00278473|Secondary|Hamilton Anxiety Rating Scale|Mean Change in Hamilton Anxiety Rating Scale at 12 weeks as compared to baseline. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
2833046|NCT00278473|Secondary|Beck Depression Inventory|"Mean change in the Beck Depression Inventory Scale at 12 weeks as compared to baseline.~The Beck Depression Inventory, 2nd edition to assess Depression symptoms. BDI-II scores range between 0 and 63, with categorical depression ratings of minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63)."|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
2833047|NCT00278473|Secondary|CAARS-O:L|Change in the Conners Adult ADHD Rating Scales-Observer: Long Version (CAARS-O:L), inattention/memory subscale at 12 weeks as compared to baseline. 12 items subscale. T-score of at least 63 gives risk or possible diagnosis of ADHD. This number, lower or higher, does not indicate severity.|baseline and at 12 weeks||||T-score||Standard Deviation|Mean
2833048|NCT00278473|Primary|Time Management, Organization, and Planning Subscale|"Time management, organization, and planning subscale at posttreatment at 12 weeks as compared to baseline.~The mean difference On Time Management Organization and Planning scale which is a 24-item self-report questionnaire that uses a 7-point Likert-type scale ranging from -3 (far below average) to +3 (far above average) and subsequently totaled to obtain a composite index of proficiency (possible scores range from -102 to +102), which was developed and previously used at the ADHD program at the Icahn School of Medicine at Mount Sinai."|baseline and at 12 weeks||||units on a scale||Standard Deviation|Mean
2833049|NCT00278473|Primary|Inattention Subscale|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Inattention subscale. Mean change score at 12 weeks as compared to baseline. Each item is scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe); the maximum total score with 27 points being the most severe.|12 weeks||||units on a scale||Standard Deviation|Mean
2833050|NCT00278395|Secondary|Safety and Tolerability||1 year|Data were not collected||||||
2833051|NCT00278395|Secondary|Overall Survival (OS) and Median OS||1 year|Data were not collected||||||
2833052|NCT00278395|Secondary|Progression-free Survival||1 year|Data were not collected||||||
2833053|NCT00278395|Primary|Objective Response|"Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria.~Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The overall duration of response will be estimated using the Kaplan-Meier method for all patients who presented with an objective response.|||participants|||Number
2833054|NCT00278343|Secondary|Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0||Up to 4 years|Data were not collected.||||||
2833055|NCT00278343|Secondary|Duration of Overall CA-125 Response|Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by > 50%.|Up to 4 years|"1 confirmed PR observed in PS group. Response will be defined as reduction in level of pre-treatment sample by > 50%.~0 confirmed PR observed in PR group."|||weeks|||Number
2833056|NCT00278343|Secondary|Progression-free Survival (PFS)|The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.|Time from start of treatment to time of progression, assessed up to 6 months||||months||95% Confidence Interval|Median
2833057|NCT00278343|Secondary|Overall Survival (OS) (Discontinued as of 4/25/2014)|The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months.||||months||95% Confidence Interval|Median
2833058|NCT00278343|Secondary|Time to Disease Progression|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 4 years|Platinum sensitive cohort|||months||95% Confidence Interval|Median
2833059|NCT00278343|Primary|Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR+PR|After 16 weeks|Total # of Patients 74 PL-S (platinum sensitive) 39 patients PL-R (platinum resistant) 35 patients Confirmed PR PL-S group 9/39 patients Confirmed PR PL-R group 0/35 patients|||participants|||Number
2833060|NCT00278200|Secondary|Prevention of Primary Epstein-Barr Virus (EBV) Infection|Number of participants who were EBV-seronegative at baseline, received at least one vaccination, subsequently received a solid organ transplant (not part of this protocol), and did not develop a primary EBV infection.|Up to 5 years|Only one participant met the criteria described in the outcome description. This participant was never tested post-transplant for EBV, so no data was collected for this outcome measure.||||||
2833061|NCT00278200|Secondary|Adverse Events Associated With the Vaccine|Number of participants who received at least one vaccination and experienced at least one grade 3-4 adverse event by CTCAE 2.0 that was attributed to protocol therapy.|Up to 5 years||||Participants|||Count of Participants
2833062|NCT00278200|Primary|Efficacy of Vaccine as Assessed by T-cell Responses|Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection.|Up to 67 days|T-cell responses were uninterpretable on lab analysis; therefore, data was not collected to assess this outcome measure.||||||
2833063|NCT00278161|Primary|Event-free Survival|Percentage of participants alive without disease relapse.|5 years|Participants were split into two populations for this outcome only: mantle-cell lymphoma and other low-grade B-cell tumors.|||percentage of participants|||Number
2833064|NCT00278161|Primary|Non-relapse Mortality|Number of participants who died for reasons related to protocol treatment.|5 years||||Participants|||Count of Participants
2833065|NCT00278161|Primary|Engraftment|Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count >= 500 cells per microliter; platelet recovery is defined as untransfused platelet count >= 20 * 10^9 cells per liter.|Up to 43 days||||days||Full Range|Median
2833066|NCT00278109|Primary|Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity|"Number of participants with Grade 4 toxicity as defined by the following criteria:~Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= Necrosis"|up to 5 years|Data was only collected on participants who completed the study.|||Participants|||Count of Participants
2833067|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Measurements|"ICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode.~Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs."|Baseline||||ms||Standard Deviation|Mean
2833068|NCT00277524|Secondary|Frequencies of Subjects With OptiVol Trends and Disease Progression.|"Estimate the correlation between OptiVol trends and disease progression.~A subject's disease status was said to have progressed if:~The NYHA classification number increases (example: I to II), or~The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or~The subject expires~A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'."|4 years post implant||||participants|||Number
2833069|NCT00277524|Secondary|"Compare First Shock Rate Between Medtronic PainFREE Programming and SCD-HeFT Programming in Primary Prevention Study Participants."|"First shock rate for VF and FVT zones was estimated using Kaplan-Meier method.~OMNI PainFREE definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.~OMNI SCD-HeFT definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms."|4 years post implant||||rate||Standard Deviation|Mean
2833070|NCT00277524|Secondary|Summary of ATP Episodes Within All Treated Episodes|Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.|4 years post enrollment||||Episodes|||Number
2833071|NCT00277524|Secondary|AV Block Status by Severity of Historical AV Block|Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block|4 years post implant||||participants|||Number
2833072|NCT00277524|Secondary|AV Block Status by Device Type at 6 and 12 Months.|Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.|12 months post enrollment||||participants|||Number
2833073|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Frequencies|ICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline||||participants|Participants||Number
2833074|NCT00277524|Primary|Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.|Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline||||participants|||Number
2833075|NCT00277524|Primary|Implanted Systems Frequencies|Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).|Baseline||||participants|||Number
2833076|NCT00277446|Secondary|Forced Expiratory Volume in One Second (FEV1)|Forced expiratory volume in one second (FEV1) measured as liters/second|0 and 4 weeks||||liters/sec||Standard Deviation|Mean
2833077|NCT00277446|Secondary|Eosinophil LTC4 Synthesis|Peripheral blood eosinophils were isolated before and after treatment with Novasoy, stimulated with calcium ionophore, and the amount of leukotriene C4 (LTC4) produced was measured by EIA.|0 and 4 weeks||||ng/ml||Standard Deviation|Mean
2833078|NCT00277446|Primary|Exhaled Nitric Oxide|Exhaled nitric oxide at baseline (week 0) and at 4 weeks|0 and 4 weeks|Per protocol|||parts per billion (ppb)||Standard Deviation|Mean
2833079|NCT00277394|Secondary|Number of Patients With Major Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses|||Patients|||Number
2833103|NCT00276861|Primary|Response Rate as Measured by RECIST Criteria|Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.|4 - 6 months||||percentage of particpants||95% Confidence Interval|Number
2833080|NCT00277394|Secondary|Number of Patients With Recurrence of Venous Thromboembolism||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses|||Patients|||Number
2833081|NCT00277394|Primary|Number of Patients With Clinically Relevant Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses|||Patients|||Number
2833082|NCT00277355|Secondary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]|TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best). Regression based imputation was used to impute missing values.|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.|||units on a scale||Standard Deviation|Mean
2833083|NCT00277355|Primary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]|Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale [UHDRS] between baseline & Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.|||units on a scale||Standard Deviation|Mean
2833084|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.|||units on a scale||Standard Error|Mean
2833085|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.|||units on a scale||Standard Error|Mean
2833086|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.|||units on a scale||Standard Error|Mean
2833087|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 2||Phase 2 (52 Week Double-blind Relapse Assessment Phase)|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).|||participants|||Number
2833088|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 1||Phase 1 (9 to 24 Week Single-blind Stabilization Phase)|Phase 1 Safety Sample (all patients who take at least one dose of singleblind aripiprazole in Phase 1, as indicated on the study therapy form).|||participants|||Number
2833089|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)|Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)|Throughout Phase 2 of the study, up to Week 52|Phase 2 safety sample|||particiapnts|||Number
2833104|NCT00276744|Primary|6-month Overall Survival|Percentage of patients survived at 6 months for patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model|6 months||||percentage of participants|||Number
2833105|NCT00276614|Primary|Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses||2 months|2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.|||participants|||Number
2833090|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment|In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.|Up to 52 Weeks|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).|||participants|||Number
2833091|NCT00277212|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment|Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.|Throughout the study, up to Week 52|Participants with ECG evaluation from the phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.)|||particiapnts|||Number
2833092|NCT00277212|Secondary|Adjusted Mean Change From Baseline in BMI by Study Week|Adjusted for index mood episode and baseline assessment.|Baseline, Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.|||kg/m2||Standard Error|Mean
2833093|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Gain by Study Week|Weight gain of at least a 7% increase from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.|||Participants|||Number
2833094|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Loss by Study Week|Weight Loss of at least a 7% decrease from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.|||Participants|||Number
2833095|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Body Weight, Phase 2|Adjusted for index mood episode and baseline assessment|Baseline, Week 52|Participants from the phase 2 Safety Sample who had body weight evaluation at baseline and week 52 LOCF.|||kg||Standard Error|Mean
2833096|NCT00277212|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout Phase 2 (up to 52 weeks)|The Phase 2 Safety Sample comprises all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.|||participants|||Number
2833097|NCT00277212|Secondary|Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
2833098|NCT00277212|Secondary|Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
2833099|NCT00277212|Secondary|Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
2833100|NCT00277212|Primary|Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)|Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.|||Proportion of Participants|||Number
2833101|NCT00277095|Primary|Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.|The percentage of participants with 50% reduction in pad weight.|18 month follow-up|As followed analysis of all patients who were treated and reached the 18 month follow-up visit|||percentage of patients||95% Confidence Interval|Number
2835010|NCT00258206|Secondary|Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited||2, 3, 6, 9, and 12 months|||||||
2833106|NCT00276549|Primary|Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.|at 4 weeks after treatment completion|25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable.|||participants|||Number
2833107|NCT00276549|Primary|Objective PSA Response Rate (Number of Patients With a PSA Response)|Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.|every 4 weeks|All patients that received treatment.|||participants|||Number
2833108|NCT00276484|Secondary|Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||6 Weeks|Full Analysis Set|||Participants|||Number
2833109|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)|Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833110|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio|Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833111|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio|Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833112|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio|Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent change||95% Confidence Interval|Least Squares Mean
2833113|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio|Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks||||Percent Change||95% Confidence Interval|Least Squares Mean
2833114|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)|Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833115|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)|Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833116|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Triglycerides (TG)|Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833117|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol|Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833118|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)|Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833119|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)|Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set|||Percent Change||95% Confidence Interval|Least Squares Mean
2833120|NCT00276484|Primary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C|Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
2833121|NCT00276458|Secondary|Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6||6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Participants|||Number
2833122|NCT00276458|Post-Hoc|Percent Change in C-Reactive Protein (CRP) at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833123|NCT00276458|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||percent||95% Confidence Interval|Least Squares Mean
2833139|NCT00276406|Secondary|Heart Rate Before and After Treatment|Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)||||beats per minute||Standard Error|Mean
2835011|NCT00258206|Secondary|Complete Response (CR) Rate and Partial Response (PR) Rate||1 year|||||||
2833124|NCT00276458|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833125|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833126|NCT00276458|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833127|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833128|NCT00276458|Post-Hoc|Percent Change in Apolipoprotein A-I at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833129|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833130|NCT00276458|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833131|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol at Week 6|([6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||percent||95% Confidence Interval|Least Squares Mean
2833132|NCT00276458|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833133|NCT00276458|Secondary|Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833134|NCT00276458|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6|[(6 week value - baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.|||Percent||95% Confidence Interval|Least Squares Mean
2833135|NCT00276419|Secondary|Mean Days of Pain During the 10 Week Treatment Periods|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.|Approximately 12 weeks and at 24 weeks after randomization|||||||
2833136|NCT00276419|Primary|Severity of Breast Pain|Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks|||||||
2833137|NCT00276419|Primary|Frequency of Breast Pain|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks|||||||
2833138|NCT00276406|Secondary|QTc Interval Before and After Treatment|The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)||||Milliseconds||Standard Error|Mean
2833140|NCT00276406|Secondary|Stool Frequency Per Week|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||Number complete bowel movements per week||Standard Error|Mean
2833141|NCT00276406|Secondary|Sense of Completely Emptying Bowels|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||percentage of bowel movements||Standard Error|Mean
2833142|NCT00276406|Secondary|Stool Ease of Passage|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||units on a scale||Standard Error|Mean
2833143|NCT00276406|Secondary|Stool Form/Consistency|"During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|Daily during baseline period (9 days), Treatment period (7 days)||||units on a scale||Standard Error|Mean
2833144|NCT00276406|Secondary|Stool Frequency Per Day|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)||||Number of bowel movements||Standard Error|Mean
2833145|NCT00276406|Secondary|Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)||||units on a scale||Standard Error|Mean
2833146|NCT00276406|Secondary|Colonic Filling at 6 Hours|The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time.|Baseline period (9 days), Treatment period (7 days)||||percentage of meal||Standard Error|Mean
2833147|NCT00276406|Secondary|Gastric Emptying Half-time (GE t1/2)|The measure of time for 50 percent of a radio-labeled meal to empty from the stomach.|Baseline period (9 days), Treatment period (7 days)||||minutes||Standard Error|Mean
2833148|NCT00276406|Primary|Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours|Calculated by linear interpolation of values on the AC emptying curve.|Baseline period (days 7-9 ), Treatment period (days 14-17)||||hours||Standard Error|Mean
2833149|NCT00276406|Primary|Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)||||units on a scale||Standard Error|Mean
2833150|NCT00276380|Secondary|Mean Change From Baseline in the National Institute of Health Stroke Scale (NIHSS) Subscore for Questions 1a,1b and 1c at Day 28, Day 84 and Day 168.|"The NIHSS was to be used to objectively quantify the impairment caused by the stroke.The NIHSS is composed of 11 items, each of which score a specific ability between 0 (normal function) and 4 (high level of impairment).The minimum total score is 0 and maximum is 42. Only 8 of the NIHSS subscores were calculated for this study.~Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. Mean NIHSS subscores for questions 1a (level of consciousness),1b (asking patient the month and their age), and 1c (asking to open and close eyes) were analysed using descriptive quantitative statistics at each visit and the mean change from baseline at each time point is reported. The range for the subscore for items 1a is 0 - 3, for 1b is 0 - 2 and for 1c is 0 - 2 (best to worst), with a negative mean change from baseline indicating an improvement."|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
2833151|NCT00276380|Secondary|Mean Change From Baseline in the Mini Mental State (MMS) Test Scores at Day 28, Day 84 and Day 168.|The MMS test was used to evaluate the cognitive function of the subject. It includes tests of orientation, attention, memory, language and visual spatial skills, which are rated with a given number of points assigned to each level or ranking. The lower the score, the more important the mental deficit. The total score range is from 0 to 30 (worst to best), with a positive mean change indicating an improvement (i.e. less mental deficit). Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
2833227|NCT00274937|Secondary|Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment|Presence of EBV DNA in serum.|At study enrollment|Data was and never will be collected.||||||
2833152|NCT00276380|Secondary|Mean Change From Baseline in Barthel Index Scores at Day 28, Day 84 and Day 168.|"The performance in activities of daily living was assessed by using the Barthel scale. The Barthel scale is an ordinal scale which measures 10 performance items describing activities of daily living. Each item is rated with a given number of points from 0 indicating total dependence up to a maximum of 10 or 15 (depending on performance item) indicating complete independence. The total score range is from 0 to 100 (worst to best), with a positive mean change indicating an improvement in independence.~Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported."|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
2833153|NCT00276380|Secondary|Mean Change From Baseline in Sandoz Clinical Assessment-Geriatric (SCAG) Scores at Day 28, Day 84 and Day 168.|The SCAG scale was to be used to evaluate the psychopathological state of the subject. It is composed of 18 symptom areas and an overall global assessment, all rated on a 7-point format from 1=not present to 7=severe. The total score range is from 19 to 133 (best to worst), with a negative mean change from baseline indicating an improvement in symptoms. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168 and the mean change from baseline at each time point is reported.|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||units on a scale||Standard Deviation|Mean
2833154|NCT00276380|Secondary|Percentage of Subjects at Each Point on the Modified Rankin Scale at Baseline, Day 28, Day 84 and Day 168.|The degree of disability and dependence in daily activities was assessed using the modified Rankin scale.The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability,3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The distribution of subjects according to disability severity scores was assessed and the percentage of subjects at each point on the modified Rankin scale are reported for each time point.|Up to Day 168|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||percentage of participants|||Number
2833155|NCT00276380|Secondary|Percentage of Subjects With Modified Rankin Score of Less Than 3 at Day 28 and Day 84.|The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at each follow-up visit (not including end of study) are reported.|Up to Day 84|This analysis was performed on the ITT population which includes all subjects having at least one treatment dose.|||percentage of participants|||Number
2833156|NCT00276380|Primary|Percentage of Subjects With Modified Rankin Score of Less Than 3 at the End of Study Period.|The degree of disability and dependence in daily activities was assessed using the modified Rankin scale. The modified Rankin scale is a 6-point numerical scale (0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderately severe disability, 5=severe disability) which measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. Assessments were made at baseline (Day 0) and at each follow-up visit on Day 28, Day 84 and Day 168. The percentage of subjects having a modified Rankin Score<3 at the end of the study (Day 168) are reported.|Day 168|This analysis was performed on the Intention-To-Treat (ITT) population which includes all subjects having at least one treatment dose.|||percentage of participants|||Number
2833157|NCT00276250|Secondary|Number of Subjects With Normal Renal Function, as Measured by Serum Creatinine Levels|Renal function was assessed by measuring levels of serum creatinine. Normal values range from 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women.|24 months after transplant|One subject in the Efalizumab followed by abatacept regimen arm withdrew from the the study at 18 months post-transplantation and therefore did not have the 24-month assessments.|||participants|||Number
2833158|NCT00276250|Secondary|The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.|The number of study participants who have detectable C-peptide levels after stimulation from a Mixed Meal Test. An increase of C-peptide indicates that insulin is being released normally in response to food consumption.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm for 18 and 24 months post-transplant|||participants|||Number
2833159|NCT00276250|Secondary|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels|The number of subjects exhibiting C-peptide levels ≥ 0.5 ng/mL was recorded.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm at the 18 and 24 months post-transplant timepoints.|||participants|||Number
2833160|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 36 months after transplantation and the number of subjects with values < 6.5% was recorded which indicated better control of blood glucose levels.|36 months post-transplantation|Two participants in the Efalizumab followed by abatacept regimen arm were terminated prior to this time point due to islet graft failure; another one withdrew as they did not want to change to abatacept. The single participant in the Abatacept arm withdrew after graft failure which occurred at 6months post-transplantation.|||participants|||Number
2833161|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 24 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|24 months post-transplant|One participant in the Efalizumab followed by abatacept regimen arm had partial graft function and withdrew from the study at 18 months post-transplantation (prior to this time point of assessment).|||participants|||Number
2833162|NCT00276250|Secondary|Number of Subjects With HbA1C Levels < 6.5%|HbA1C was assessed in the subjects 12 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|12 months post-transplantation||||participants|||Number
2833163|NCT00276250|Secondary|Number of Subjects With HbA1C Less Than 6.5%|HbA1C was assessed in the subjects 6 months after transplantation and the number of subjects with values less than 6.5% was recorded which indicated better control of blood glucose levels.|6 months post-transplantation|The HbA1C for the subject in the abatacept arm was above the threshold (6.5%) for this measure.|||participants|||Number
2833164|NCT00276250|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 9, 12, 18, and 24 months following islet transplantation|1, 3, 6, 9,12,18 and 24 months post-transplantation||||participants|||Number
2833165|NCT00276250|Primary|The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation||75 days post-transplantation||||participants|||Number
2833166|NCT00276159|Secondary|Peak Concentrations of 852A|Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.|Up to Week 12|Not able to analysis due to sale of agent - unable to perform.||||||
2833167|NCT00276159|Secondary|Measure of Immune Activation With Correlative Laboratory Studies||Up to Week 12|Analysis not done to sale of agent - unable to perform.||||||
2833168|NCT00276159|Secondary|Number of Patients Who Received Steroids|Number of patients who received steroids allowing successful continuation of therapy.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.|||Participants|||Number
2833169|NCT00276159|Primary|Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors|Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.|||Participants|||Number
2833170|NCT00276094|Secondary|Change From Baseline in Urinary Symptoms||Baseline (Randomization) to Week 12||||Participants|||Number
2833171|NCT00276094|Secondary|Change From Baseline in Testosterone (Total) Levels||Baseline (Screening) to Week 12||||ng/dL||Standard Deviation|Mean
2833172|NCT00276094|Secondary|Change From Baseline in Testosterone (Free) Levels||Baseline (Screening) to Week 12||||ng/dL||Standard Deviation|Mean
2833173|NCT00276094|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||Baseline (Screening) to Week 12||||nmol/L||Standard Deviation|Mean
2833174|NCT00276094|Secondary|Change From Baseline in Luteinizing Hormone Levels||Baseline (Screening) to Week 12||||IU/L||Standard Deviation|Mean
2833175|NCT00276094|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||Baseline (Screening) to Week 12||||IU/L||Standard Deviation|Mean
2833176|NCT00276094|Primary|Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12||||percentage of superficial cells||Standard Deviation|Mean
2833177|NCT00276094|Secondary|Change From Baseline in Estradiol Levels||Baseline (Screening) to Week 12|"Analysis populations for each hormone:~Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178"|||pg/mL||Standard Deviation|Mean
2833178|NCT00276094|Secondary|Change From Baseline in Severity of VVA Symptoms|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12||||Units on a scale||Standard Deviation|Mean
2833179|NCT00276094|Secondary|Change From Baseline in Visual Evaluation of the Vagina|Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Screening) to Week 12||||Units on a scale||Standard Deviation|Mean
2833180|NCT00276094|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12||||percentage of parabasal cells||Standard Deviation|Mean
2833181|NCT00276094|Primary|Mean Change From Baseline in Vaginal pH||Baseline (Screening) to Week 12||||pH||Standard Deviation|Mean
2833182|NCT00276094|Primary|Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12||||Units on a scale||Standard Deviation|Mean
2833183|NCT00276094|Primary|Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness|This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12||||Units on a scale||Standard Deviation|Mean
2833184|NCT00276016|Secondary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.|"To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo~The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)||||Units on a scale||Standard Deviation|Mean
2833185|NCT00276016|Primary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo|"To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.~The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)||||Units on a scale||Standard Deviation|Mean
2833186|NCT00275834|Secondary|Change in Blood Pressure||Baseline, 1 year||||mm Hg||95% Confidence Interval|Least Squares Mean
2833354|NCT00272844|Primary|Number of Responders|Responders was defined as an increase in total serum cholesterol and a decrease in 7-DHC (7-Dehydrocholesterol), and 8-DHC (8-Dehydrocholesterol) were measured on all participants.|Every 3-6 months for an approximate median of 5 years||||Participants|||Count of Participants
2833187|NCT00275834|Secondary|Quality of Life as Measured by HADS_D|Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|1 year||||units on a scale||95% Confidence Interval|Least Squares Mean
2833188|NCT00275834|Secondary|Change in Lipids||baseline, 1 year||||mg/dL||95% Confidence Interval|Least Squares Mean
2833189|NCT00275834|Secondary|Inflammatory Markers (CRP)|C reactive Protein (CRP)|1 year|Participants who had CRP testing completed|||mg/L||Standard Error|Mean
2833190|NCT00275834|Secondary|Waist Circumference|Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.|1 year|intent-to-treat|||cm||95% Confidence Interval|Mean
2833191|NCT00275834|Secondary|Proportions of Patients With 10% Weight Loss|This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.|1 year||||participants|||Number
2833192|NCT00275834|Secondary|Proportions of Patients With 5% Weight Loss|These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.|1 year||||participants|||Number
2833193|NCT00275834|Primary|Change in Body Weight|The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.|1 year|intent-to-treat|||kg||95% Confidence Interval|Mean
2833194|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.|||Micrometers||Standard Deviation|Mean
2833195|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.|||micrometers||Standard Deviation|Mean
2833196|NCT00275821|Secondary|Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12|Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).|Baseline to Month 12|The intent to treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.|||mm^2||Standard Deviation|Mean
2833197|NCT00275821|Primary|Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12|Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline to Month 12|Per-Protocol (PP) population includes a subset of patients from the Intent to Treat (ITT) population who completed Month 12/Visit 15, had an assessment of Best Corrected Visual Acuity in the study eye at Month 12/Visit 15 and did not have any major study protocol deviations.|||letters||Standard Deviation|Mean
2833198|NCT00275561|Secondary|Number of Participants With Complete Histologic Response|A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field|2 weeks|Analysis was run per protocol.|||participants|||Number
2833199|NCT00275561|Secondary|Number of Participants With Partial or Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)? A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level."|2 weeks|Analysis was run per protocol.|||participants|||Number
2833200|NCT00275561|Primary|Number of Participants With Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"|2 weeks|Analysis was run per protocol.|||participants|||Number
2833201|NCT00275509|Primary|6-month Cumulative Rejection Incidence (Either CMR, AMR or Both)|Biopsy shows evidence of either AMR or CMR or evidence both.|Up to 6 months|One patient in the Thymoglobulin arm died on post-operative day #8, prior to undergoing a biopsy. There were other deaths in the study however there were incidences of CMR, AMR or both prior to death.|||Participants|||Count of Participants
2833355|NCT00272792|Secondary|Change in Phenylalanine Levels From Baseline to Week 3||Baseline to Week 3||||umol/L||Standard Error|Mean
2833356|NCT00272792|Primary|Amount of Dietary Supplemented Phenylalanine (Phe)Tolerated in Children With Phenylketonuria||at Week 10||||mg/kg/day||Standard Deviation|Mean
2833202|NCT00275509|Primary|6-month Acute Antibody-mediated Rejection Rate (AMR)|A diagnosis of AMR was based on the 2013 international Banff Classification Criteria and is defined as the presence of circulating donor-specific antibody (DSA) and either: 1) peritubular capillary staining of C4d and at least one of the following: peritubular capillaritis (ptc) score>0, glomerulitis (g) score>0, acute thrombotic microangiopathy (TMA) in the absence of any other cause, or other features consistent with AMR (endothelial injury, fibrin thrombi, microinfarctions, interstitial hemorrhage), or 2) absence of capillary staining of C4d and the presence of ptc>0 and g>0 or ptc>0 or g>0 and acute TMA, in the absence of any other cause of TMA.|Up to 6 months|One patient in the Thymoglobulin arm died on post-operative day #8, prior to undergoing a biopsy. There were other deaths in the study however there were incidences of CMR, AMR or both prior to death.|||Participants|||Count of Participants
2833203|NCT00275509|Primary|6-month Acute Cellular-mediated Rejection Rate (CMR)|Per 2007 international Banff Classification Criteria, CMR 1A was diagnosed on biopsies displaying significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2). CMR IB was diagnosed in cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of severe tubulitis (t3). CMR IIA were cases with mild-to-moderate intimal arteritis (v1), while CMR IIB were those with severe intimal arteritis comprising >25% of the luminal area (v2). CMR III were those cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3).|Up to 6 months|One patient in the Thymoglobulin arm died on post-operative day #8, prior to undergoing a biopsy. There were other deaths in the study however there were incidences of CMR, AMR or both prior to death.|||Participants|||Count of Participants
2833204|NCT00275392|Secondary|Dynamic Visual Acuity|Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.|6 weeks||||LogMAR||Standard Deviation|Mean
2833205|NCT00275392|Primary|Dynamic Gait Index|Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 20 indicates risk for falling.|6 weeks|Per-protocol analyses (i.e., only subjects who completed the intervention were included).|||units on a scale||Standard Deviation|Mean
2833206|NCT00275340|Secondary|Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)||9 weeks||2009-09-30|09/2009||||
2833207|NCT00275340|Secondary|Function (Human Activity Profile)||9 weeks||2009-09-30|09/2009||||
2833208|NCT00275340|Secondary|Interference With Activities (Brief Pain Inventory-Interference Subscale)||9 weeks||2009-09-30|09/2009||||
2833209|NCT00275340|Secondary|Pain (McGill Pain Questionnaire-Short Form)||9 weeks||2009-09-30|09/2009||||
2833210|NCT00275340|Primary|Health-related Quality of Life (SF-36v2-acute Form)|The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|9 weeks||||units on a scale||Standard Deviation|Mean
2833211|NCT00275301|Primary|Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan|The primary aim of this imaging study was to examine the effect of olanzapine on brain metabolism over the eight weeks of administration. To compare the baseline PET scan to the endpoint scan,|Baseline to 8 weeks||||Standard uptake value||Standard Deviation|Mean
2833212|NCT00275275|Secondary|Number of Dose Adjustments|Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.|Week 4||||number of adjustments||Standard Deviation|Mean
2833213|NCT00275275|Primary|Adverse Effects Experienced|Number of adverse effect experienced by participants in the different conversion ratio groups.|Week 4||||number of events|||Number
2833214|NCT00275262|Primary|Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||spots/1 million cells||Standard Deviation|Mean
2833215|NCT00275262|Primary|Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||mcg/mL||Standard Deviation|Mean
2833228|NCT00274937|Primary|Two Year Event-free Survival (EFS)|The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.|Up to Two Year After Enrollment|No patients were enrolled to Stratum 1.|||Estimated probability||95% Confidence Interval|Number
2833229|NCT00274924|Secondary|5-year Overall Survival|5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.|Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.||||probability||90% Confidence Interval|Number
2833216|NCT00275262|Secondary|Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD8+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD8+ cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010~The change from baseline is defined as posttransplant TREC/100,000 CD8+ cells minus pretransplant TREC /100,000 CD8+ cells."|Pretransplant and posttransplant (Month 12)|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||TREC /100,000 CD8+ cells||Standard Deviation|Mean
2833217|NCT00275262|Secondary|Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010~The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells."|Pretransplant and posttransplant (Month 12)|Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||TREC /100,000 CD4+ cells||Standard Deviation|Mean
2833218|NCT00275262|Primary|Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.|||mcg/mL||Standard Deviation|Mean
2833219|NCT00275028|Secondary|Progression-free Survival||Up to 2 years||||weeks||Standard Error|Mean
2833220|NCT00275028|Primary|Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST)~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Up to 12 months||||participants|||Number
2833221|NCT00275002|Secondary|Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide|Clinical and laboratory studies to assess adverse events are obtained at least every four weeks (prior to each course) with some laboratory studies obtained every 2 weeks. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Attribution of each adverse event to the treatment regimen is determined by the participant's attending physician at the enrolling institution and verified by the study chair.|From day 1 of therapy up to 49 months|Participants who received at least one day of the treatment regimen were included in the analysis of this objective.|||Participants|||Number
2833222|NCT00275002|Primary|Percentage of Participants With an Objective Response (Complete Response or Partial Response)|The primary endpoint is to assess the percentage of participants with a sustained objective response (complete response (CR) or partial response (PR)). Response is assessed by magnetic resonance imaging (MRI) per the following criteria: CR - disappearance of tumor and PR - ≥50% reduction in tumor based on the maximal cross-sectional measurements. The response must be sustained for at least 8 weeks, and the date of the confirmed sustained response is the date at which the response was first noted by MRI.|Week 8, 16, 24, 32, and 40 after starting therapy|Participants included in assessing objective response were those who completed two courses of therapy or those who died or experienced progressive disease prior to completing the second course.|||Percent of Participants||95% Confidence Interval|Number
2833223|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.|Weight of unstimulated saliva production in grams.|At study enrollment|Twenty-nine patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of unstimulated saliva production. This outcome measure was only collected for patients in Stratum 2.|||Grams of saliva||Standard Deviation|Mean
2833224|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry|Weight of stimulated saliva production in grams.|At study enrollment|Twenty-six patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of stimulated saliva production. This outcome measure was only collected for patients in Stratum 2.|||Grams of saliva||Standard Deviation|Mean
2833225|NCT00274937|Secondary|Predictive Value of the Detection of EBV DNA in the Peripheral Blood|The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial.|Up to 6 years|Funding was not obtained and results will never be reported.||||||
2833226|NCT00274937|Secondary|Prognostic Significance of EBV Viral Load|Viral load in blood.|At study enrollment|Data was and never will be collected.||||||
2835012|NCT00258206|Secondary|Safety and Toxicity||2, 3, 6, 9, and 12 months|||||||
2833230|NCT00274924|Primary|2-year Progression-Free Survival (PFS)|2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.|Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.||||probability||90% Confidence Interval|Number
2833231|NCT00274846|Secondary|Number of Patients With Complete Remission and Natural Killer Cell Expansion|Includes patients who had both a complete remission of disease and an expansion of natural killer cells.|Day 14|Unable to evaluate due to low complete remission rate.||||||
2833232|NCT00274846|Secondary|Overall Survival Time of Patients With Complete Remission|Median number of months patients were alive after NK cell infusion.|From Day 1 of Treatment until death or patient received bone marrow transplant.||||Months||Full Range|Median
2833233|NCT00274846|Secondary|Median Time to Disease Relapse (Months)|Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.|From 1st Day of treatment until death or receipt of bone marrow transplant.|Only 2 of 20 patients that received adequate Natural Killer Cells achieved complete remission, and were therefore evaluable for the time to relapse endpoint.|||Months||Full Range|Median
2833234|NCT00274846|Secondary|Number of Patients With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery).|Day 28-35||||Participant|||Number
2833235|NCT00274846|Primary|Number of Patients With Natural Killer (NK) Cell Expansion|Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).|Study Day 14||||Participants|||Number
2833236|NCT00274781|Secondary|Tolerability|Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity.|12 Weeks||||participants|||Number
2833237|NCT00274781|Secondary|Overall Survival|Patient's Overall Survival from date of enrollment to a minimum of three years for survival.|From date of enrollment to a minimum of three years for survival||||months||Full Range|Median
2833238|NCT00274781|Primary|Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)|The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is <10%. A total of >/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.|at 12 weeks post treatment|Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)|||percentage of patients|||Number
2833239|NCT00274768|Secondary|Time to Treatment Failure|Time to treatment failure in weeks|3-week cycles of treatment up to 16 cycles|Five patients did not complete cycle 1|||weeks||Full Range|Median
2833240|NCT00274768|Secondary|Adherence and Compliance to Oral Medication Using Electronic Monitoring|This was assessed by number of participants who did not miss any doses of Capecitabine during treatment using the Medication Event Monitoring System (MEMS).|3-week cycles of treatment up to 16 cycles||||Participants|||Count of Participants
2833241|NCT00274768|Secondary|Pharmacokinetics of Capecitabine and Metabolites as Assessed by Area Under the Curve (AUC)|Pharmacokinetics of Capecitabine and metabolites [5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-FU] assessed using AUC in ng*h/mL.|0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours||||ng*h/mL||Standard Deviation|Mean
2833242|NCT00274768|Secondary|Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration|Pharmacokinetics of Capecitabine and metabolites [5-fluoro-5'-deoxycytidine (5'-DFCR), 5-fluoro-5'-dexoxyuridine (5'-DFUR), and 5-fluorouracil (FU)] assessed using maximum plasma concentration (Cmax) in ng/mL.|0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours||||ng/mL||Standard Deviation|Mean
2833243|NCT00274768|Secondary|Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks|The overall clinical benefit rate as assessed by number of participants with lack of progression for at least 24 weeks.|3-week cycles of treatment up to 16 cycles|Five patients did not complete cycle 1|||Participants|||Count of Participants
2833244|NCT00274768|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Participants were followed to progression, evaluated every 12 weeks|Any participant who completed at least one (1) cycle of capecitabine administration was evaluable for response.|||participants|||Number
2833245|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (With Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease.~If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab|||participants|||Number
2833378|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96||Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.|||kg/m^2||Standard Error|Mean
2833246|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (Without Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration).~Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status.~If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab|||participants|||Number
2833247|NCT00274742|Secondary|Serum Concentration of Blinatumomab|The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis.|Up to 24 hours after the end of infusion.|Participants who received blinatumomab and had available pharmacokinetic data|||pg/mL||Standard Deviation|Mean
2833248|NCT00274742|Primary|Number of Participants With Adverse Events|Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events|From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.|All participants who received at least one infusion of blinatumomab|||participants|||Number
2833249|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
2833250|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
2833251|NCT00274716|Primary|Number of Participants Who Reported a Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
2833252|NCT00274716|Primary|Number of Participants Who Reported a Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.|||Participants|||Number
2833253|NCT00274716|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)|TG measured at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||Percent change||Standard Deviation|Mean
2833254|NCT00274716|Secondary|Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI|HDL-C measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||Percent change||Standard Deviation|Mean
2833255|NCT00274716|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)|LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||percentage change||Standard Deviation|Mean
2833507|NCT00271544|Secondary|All Medtronic Left Ventricular Leads (Attain Family)|All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted|Implant|Subjects who underwent an implant attempt.|||participants|||Number
2833256|NCT00274716|Secondary|Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI|Waist circumference measured in cm at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||cm||Standard Deviation|Mean
2833257|NCT00274716|Secondary|Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI|Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||kg||Standard Deviation|Mean
2833258|NCT00274716|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||mm Hg||Standard Deviation|Mean
2833259|NCT00274716|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.|||mm Hg||Standard Deviation|Mean
2833260|NCT00274651|Post-Hoc|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals|||participants|||Number
2833261|NCT00274651|Secondary|Duration of Response|Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.|throughout the study, or for a maximum of 2 years|Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days|||Days||Full Range|Median
2833262|NCT00274651|Secondary|Time to Response|Time to response was defined as the interval between the first date of treatment and the first notation of response.|throughout the study, or for a maximum of 2 years|Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.|||Days||Full Range|Median
2833263|NCT00274651|Secondary|Time to Progression|Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.|throughout the study, or for a maximum of 2 years|Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.|||Days||Full Range|Median
2833264|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))|Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.|throughout the study, or for a maximum of 2 years|Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama & Chen (2008) are presented|||percentage of patients with OR|||Number
2833265|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals||||||
2833266|NCT00274625|Primary|Incisional Hernia|An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.|2 years|14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.|||participants|||Number
2833267|NCT00274469|Post-Hoc|Overall Survival|Time from randomization to death (any cause)|From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled.|Full Analysis Set|||Month||Inter-Quartile Range|Median
2833268|NCT00274469|Secondary|Time to Progression (Investigator Assessed)|Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.|From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.|Full Analysis Set.|||Day||Inter-Quartile Range|Median
2833269|NCT00274469|Secondary|Time to Treatment Failure|Time from randomization to treatment discontinuation|From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.|Full analysis set.|||Day||Inter-Quartile Range|Median
2833270|NCT00274469|Secondary|Time to Progression|Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.|From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.|Full Analysis Set.|||Day||Inter-Quartile Range|Median
2833271|NCT00274469|Secondary|Objective Response Rate|For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.|From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.|Evaluable For Response Set|||Percentage of Participants|||Number
2833272|NCT00274469|Primary|Clinical Benefit Rate|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.|From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.|Full Analysis Set|||Percentage of Participants|||Number
2833273|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts|Maximal degree of myelosuppression is represented by the nadir in hemoglobin (Hb) measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.|||g/L||Standard Deviation|Mean
2833274|NCT00274456|Secondary|Participants With Treatment-Emergent, Treatment-Related Adverse Events|Summary of participants who had treatment-emergent that were treatment-related in the opinion of the investigator, and summarized in a variety of categories. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||participants|||Number
2833275|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts|Maximal degree of myelosuppression is represented by the nadir in absolute neutrophil (ANC), white blood cell (WBC), and platelet measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.|||10^9/L||Standard Deviation|Mean
2833276|NCT00274456|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Participant survival was defined as the date of randomization to the date of death. Participants that were alive at the time of analysis were censored at the last known time that the participant was alive. The final analysis of mature overall survival was conducted after 2 years of follow-up (data cutoff date 31 Jan 2010).|Day 1 to 221 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||months||95% Confidence Interval|Median
2833277|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The investigator assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|||months||95% Confidence Interval|Median
2833278|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The independent radiology assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|||months||95% Confidence Interval|Median
2833279|NCT00274456|Secondary|Kaplan-Meier Estimates for Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the start of disease progression (PD) or patient death (any cause), whichever occurred first. Patients without disease progression were censored at the last time the patient was known to be progression-free. Patients who initiated new anticancer therapy prior to documented progression or death were censored at the start of new therapy. Disease progression was assessed separately by investigators and by an independent radiologist. Both assessments are offered. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000). PD for target lesions is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||months||95% Confidence Interval|Median
2833280|NCT00274456|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response|Known as the disease control rate, this outcome measures the percentage of participants with stable disease for 16 weeks or more, or had a confirmed complete or partial response (see outcome #1 for confirmed response definitions). Assessments made by independent radiology and by investigators are reported separately|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2833281|NCT00274456|Primary|Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator|Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2833282|NCT00274287|Secondary|Median Number of GM-CSF Cycles||up to 12 months|all evaluable participants|||months||Full Range|Median
2833283|NCT00274287|Secondary|Median Overall Survival (OS)||up to 44 months|all evaluable participants|||months||Full Range|Median
2833284|NCT00274287|Secondary|Response Rate (Radiographic)|PR was defined as more than 30% decrease in the sum of the longest diameter of measurable lesions compared to baseline. SD was defined when lesions did not meet criteria for PR or PD. PD was defined as more than 20% increase in the sum of the longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions at imaging studies. The appearance of 2 or more new boney lesions on bone scan development of cord compression, and pathologic fractures constituted PD.|up to 21 months|all evaluable participants|||Participants|||Count of Participants
2833285|NCT00274287|Secondary|Response Rate (PSA)|Biochemical PR (Partial Response) was defined as a PSA that decreases by 50% and maintains by at least 3 weeks by confirmatory measurement. Biochemical SD (stable disease) was defined as a PSA that was increased by less than 25% or decreased by less than 50% Biochemical PD (progressive disease) was defined as an increase of at least 25% confirmed 3 weeks after.|up to 21 months|all evaluable participants|||Participants|||Count of Participants
2833286|NCT00274287|Primary|Time to Disease Progression (TTP)|The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported|up to 21 months|all evaluable participants|||months||Full Range|Median
2833287|NCT00274261|Secondary|Incidence of Adverse Events.|Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.|duration of the study - through 6 month or 12 months of use||||Participants|||Count of Participants
2833288|NCT00274261|Primary|The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.|Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.|6 months|Modified Intent-To-Treat (MITT): ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as “Typical-Use”) and for whom there is at least one report of pregnancy status.|||6 month probability of pregnancy||95% Confidence Interval|Number
2833289|NCT00273910|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|48 months||||Participants|||Number
2833290|NCT00273910|Primary|Immunologic Response Rate|Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.|48 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.|||Participants|||Number
2833291|NCT00273858|Secondary|Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month|PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.|||mm|||Number
2833292|NCT00273858|Secondary|Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month|PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.|||Millimetre (mm)|||Number
2835013|NCT00258206|Primary|Safety of Maintenance Rituximab Following High Dose Cyclophosphamide||2, 3, 6, 9, and 12 months|||||||
2833293|NCT00273858|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.|Baseline, Month 24|Data was not analyzed as the usage of the questionnaire was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.|||Units on a Scale|||Number
2833294|NCT00273858|Primary|Number of Participants by Reasons for Discontinuation of Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.|||Participants|||Number
2833295|NCT00273858|Primary|Number of Participants Who Discontinued Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.|||Participants|||Number
2833296|NCT00273858|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.|||Participants|||Number
2833297|NCT00273793|Secondary|Average Number Cigarettes Reported Smoked Each Day in the Past Week Measured at Follow-up Six Months After Entry Into the Study|average number cigarettes reported smoked each day in the past week at follow up six months after study entry|past week at follow-up six months after study entry||||cigarettes per day||Standard Deviation|Mean
2833298|NCT00273793|Primary|Breath Carbon Monoxide Levels Indicating Smoking Abstinence During the Study, i.e., the Number of Breath Samples With Carbon Monoxide (CO) Levels Less Than 3 Parts Per Million (Ppm)||daily for breath CO|all subjects randomized to condition|||number breath samples < 3 ppm CO||Inter-Quartile Range|Median
2833299|NCT00273754|Secondary|Hospital Discharge Time|Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.|Total time from end anesthesia to discharge home||||Minutes||Standard Deviation|Mean
2833300|NCT00273754|Secondary|Post Anesthesia Care Unit (PACU) Duration||Time spent in PACU following surgical procedure prior to discharge home or hospital admission.||||minutes||Standard Deviation|Mean
2833301|NCT00273754|Secondary|Awakening Time|A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.|Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.||||Minutes||Standard Deviation|Mean
2833302|NCT00273754|Secondary|Extubation Time.|Time from end of anesthesia until extubation.|Duration from anesthesia end until extubation time.||||minutes||Standard Deviation|Mean
2833303|NCT00273754|Secondary|Occurence of Post Extubatory Respiratory Adverse Events.|The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|Per protocol|||Participants|||Number
2833304|NCT00273754|Primary|Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.|The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|The analysis was per protocol.|||Participants|||Number
2833305|NCT00273182|Secondary|Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant|"A left ventricular lead related complication is defined as an adverse event that requires invasive intervention or leads to loss of significant device function resulting from the presence or performance of the LV lead.~Kaplan-Meier method was used to estimate complication-free rate during the three years of follow-up. Time to the first post-implant LV lead related complication was used for the calculation. Confidence intervals were calculated on a log-log scale."|36 months follow-up|The analysis included data from all subjects enrolled in the InSync Registry study.|||participants|||Number
2833306|NCT00273182|Secondary|Left Ventricular (LV) Lead Pacing Voltage Threshold|Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up|36 months follow-up||||Volts||95% Confidence Interval|Mean
2833307|NCT00273182|Secondary|Left Ventricular (LV) Lead Impedance|Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.|36 months follow-up||||ohms||95% Confidence Interval|Mean
2833308|NCT00273182|Secondary|Left Ventricular (LV) Lead R-wave Amplitude|Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.|36 month follow-up|1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system.|||mV||95% Confidence Interval|Mean
2833309|NCT00273182|Primary|Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.|Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules|36 month follow-up|The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system.|||participants|||Number
2833310|NCT00273052|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
2833311|NCT00273052|Secondary|Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||Percent Change|||Number
2833312|NCT00273052|Secondary|Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||ng/mL|||Number
2833313|NCT00273052|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||Percent Change|||Number
2833314|NCT00273052|Secondary|Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||uIU/mL|||Number
2833315|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||g/L|||Number
2833316|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
2833317|NCT00273052|Secondary|Change From Baseline in Weight by Treatment Group at Maintenance Month|Manual physical examination. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||kg|||Number
2833318|NCT00273052|Secondary|Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6|Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||bpm|||Number
2833379|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 48|Mean change from baseline in body weight at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||kg||Standard Error|Mean
2833319|NCT00273052|Secondary|Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6|Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mm Hg|||Number
2833320|NCT00273052|Secondary|Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6|Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mcmol/min/L|||Number
2833321|NCT00273052|Secondary|Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6|Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
2833322|NCT00273052|Primary|Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6|Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
2833323|NCT00273052|Primary|Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6|Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).|||mg/dL|||Number
2833324|NCT00272987|Secondary|Progression-free Survival as Assessed by the Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 164)|Safety Population|||Weeks||95% Confidence Interval|Median
2833325|NCT00272987|Secondary|Number of Participants With Clinical Benefit (CR, PR, and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator|Clinical benefit is defined as the numer of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population|||Participants|||Number
2833326|NCT00272987|Primary|Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 164)|Safety Population|||Percentage of participants|||Number
2833335|NCT00272987|Primary|Number of Events of Hepatotoxicity With the Indicated Characteristics|Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one of event of hepatotoxicity were analyzed.|||Events of hepatotoxicity|||Number
2833380|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 96|Mean change from baseline in weight at Week 96|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.|||kg||Standard Error|Mean
2833508|NCT00271544|Secondary|All Left Ventricular Leads|All left ventricular leads successfully implanted|Implant|Subjects who underwent an implant attempt.|||participants|||Number
2833327|NCT00272987|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.|||Weeks||Inter-Quartile Range|Median
2833328|NCT00272987|Secondary|Time to Response as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.|||Participants|||Number
2833329|NCT00272987|Primary|Number of Participants Who Received Any Concomitant Medications During the Study Period|Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period.|withdrawal/study completion (up to Study Week 164)|Safety Population|||Participants|||Number
2833330|NCT00272987|Primary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
2833331|NCT00272987|Primary|Number of Events of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics|Events of left ventricular ejection fraction (LVEF) decrease were characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. A participant could have been counted in more than one category.|Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only the participants with at least one of event of LVEF decrease were analyzed.|||Events|||Number
2833332|NCT00272987|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Degree Celsius||Standard Deviation|Mean
2833333|NCT00272987|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute (BPM)||Standard Deviation|Mean
2833334|NCT00272987|Primary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2840208|NCT00176878|Secondary|Number of Patients With Disease Recurrence|Number of patients who exhibited disease recurrence at 2 years.|2 years||||Participants|||Number
2833336|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values > upper limit of normal (ULN)=Hyper; values < lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if >2 milligram per deciliter [mg/dL]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is > twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
2833337|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population|||Participants|||Number
2833338|NCT00272987|Primary|Number of Events of Diarrhea With the Indicated Characteristics|Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one event of diarrhea were analyzed.|||Events of diarrhea|||Number
2833339|NCT00272987|Primary|Number of Participants Who Died Due to Any Cause|Number of participants who died due to any cause during the study or after completion of study were reported.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population|||Participants|||Number
2833340|NCT00272987|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population|||Participants|||Number
2833341|NCT00272987|Primary|Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the investigational product up to withdrawal/study completion (up to Study Week 164)|Safety Population: all participants who were randomized and received at least one dose of investigational product.|||Weeks||Standard Deviation|Mean
2833342|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
2833343|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
2833344|NCT00272961|Secondary|Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
2833583|NCT00270855|Primary|Fat Free Mass Between Groups|Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kg||Standard Deviation|Mean
2833345|NCT00272961|Secondary|Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.|||mmHg||Standard Error|Least Squares Mean
2833346|NCT00272961|Secondary|Standing Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
2833347|NCT00272961|Secondary|Sitting Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
2833348|NCT00272961|Secondary|Standing Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
2833349|NCT00272961|Secondary|Sitting Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.|||mmHg||Standard Error|Mean
2833350|NCT00272961|Primary|Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change|AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set: all participants who received at least 1 dose of study treatment. “N”(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.|||mmHg||Standard Error|Least Squares Mean
2833351|NCT00272961|Primary|Maximum Blood Pressure (BP) Increase|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
2833352|NCT00272844|Secondary|Number of Participants With Improved Neuropsychological Development|Improved neuropsychological development is defined as progressively achieving developmental milestones|Every 3-6 months for an approximate median of 5 years||||Participants|||Count of Participants
2833353|NCT00272844|Secondary|Number of Growth Responders|Growth response was defined as an increase in general health, growth, and behavior.|Every 3-6 months for an approximate median of 5 years||||Participants|||Count of Participants
2835014|NCT00258206|Primary|Event-free Survival|Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)|1 year||||percentage of participants|||Number
2833357|NCT00272779|Primary|Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
2833358|NCT00272779|Primary|Mean Change From Baseline in VAT Associated With RETN_730|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
2833359|NCT00272779|Primary|Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
2833360|NCT00272779|Primary|Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||cm^2||Standard Error|Mean
2833361|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||pg/mL||Standard Error|Mean
2833362|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||pg/mL||Standard Error|Mean
2833363|NCT00272779|Primary|Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||ng/dL||Standard Error|Mean
2833364|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
2833381|NCT00272779|Secondary|Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.|||g/cm^2||95% Confidence Interval|Mean
2833365|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
2833366|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
2833367|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
2833368|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
2833369|NCT00272779|Primary|Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.|||mg/dL||Standard Error|Mean
2833370|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96|Mean change From baseline in BMI at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and with values for this parameter.|||kg/m^2||Standard Error|Mean
2833371|NCT00272779|Secondary|Mean Changes From Baseline in Body Weight at Week 96|Mean change in body weight from baseline was determined.|Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||kg||Standard Error|Mean
2833372|NCT00272779|Secondary|Percentage of Participants With Lipoatrophy at Week 96|Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||percentage of participants|||Number
2833373|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 48|Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||ratio||Standard Error|Mean
2833374|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 48|Mean change from baseline in BMI at Week 48 was determined.|Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||kg/m^2||Standard Error|Mean
2833375|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 96|Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||ratio||Standard Error|Mean
2833376|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 48|Mean change from baseline in waist circumference at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||cm||Standard Error|Mean
2833377|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 96|Mean change From baseline in waist circumference at Week 96 was determined.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.|||cm||Standard Error|Mean
2833382|NCT00272779|Secondary|Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|DEXA scans were taken at Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||grams/ centimeters ^2 (g/cm^2)||95% Confidence Interval|Mean
2833383|NCT00272779|Secondary|Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA||Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Ratio||95% Confidence Interval|Mean
2833384|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Percentage||95% Confidence Interval|Mean
2833385|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Percentage||95% Confidence Interval|Mean
2833386|NCT00272779|Secondary|Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.|DEXA scans were taken at Baseline (Day 1) and at Weeks 48.|As-treated participants (with values for this parameter)in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.|||Ratio||Standard Error|Mean
2833387|NCT00272779|Secondary|Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96|Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 96.|"Resistance analysis are based on randomized population. 2 subjects with baseline phenotypic resistance to ATV/RTV are excluded. Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. n signifies the number of participants evaluable for each parameter."|||Participants|||Number
2833388|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833389|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833390|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96|Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833391|NCT00272779|Primary|Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis|19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].|Baseline visit|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. The Hardy-Weinberg Equilibrium test was used to check for the genotype quality. All SNPs passed the quality check.|||participants|||Number
2833392|NCT00272779|Primary|Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.|||Ratio||Standard Error|Mean
2835015|NCT00258180|Primary|Number of Participants Experiencing Intervention-related Adverse Events, as Defined by CTCAE at 1 Month||1 month||||Participants|||Count of Participants
2833393|NCT00272779|Primary|AUC (TAU) of Tenofovir at Week 4|AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng*h/mL||Full Range|Geometric Mean
2833394|NCT00272779|Primary|Cmin of Tenofovir at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833395|NCT00272779|Primary|Cmax of Tenofovir at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833396|NCT00272779|Primary|Cmin of RTV at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833397|NCT00272779|Primary|AUC (0-24) of RTV at Week 4|AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng*h/mL||Full Range|Geometric Mean
2833398|NCT00272779|Primary|Cmax of RTV at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833399|NCT00272779|Primary|Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4|IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833400|NCT00272779|Primary|Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4|EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833401|NCT00272779|Primary|Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|T-half was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||Hr||Standard Deviation|Mean
2833402|NCT00272779|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Tmax was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||Hr||Full Range|Median
2833403|NCT00272779|Primary|Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Cmin was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng/mL||Full Range|Geometric Mean
2833404|NCT00272779|Primary|Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.|||ng*h/mL||Full Range|Geometric Mean
2833405|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833466|NCT00271856|Primary|Change in CD4 T-cell Count||baseline to 12 months|Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months.|||cells/µl||95% Confidence Interval|Mean
2833406|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833407|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833408|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833409|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96|Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833410|NCT00272779|Secondary|Mean Changes in Fasting Insulin at Week 96|Mean change from baseline in fasting insulin at Week 96.|Baseline (Day 1) and Week 96.|Safety analyses of the treatment period are based on treated population with values for this parameter.|||µU/mL||Standard Error|Mean
2833411|NCT00272779|Secondary|Mean Changes in Fasting Glucose at Week 96|Mean change from baseline in fasting glucose at Week 96 was determined.|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.|||mg/dL||Standard Error|Mean
2833412|NCT00272779|Primary|Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.|All participants who completed the intensive pharmacokinetic (PK) study.|||nanogram(ng)/mL||Full Range|Geometric Mean
2833413|NCT00272779|Secondary|Mean Changes in Fasting Lipids at Week 96|Mean change from baseline in fasting lipids at Week 96 was determined.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.|||mg/dL||Standard Error|Mean
2833414|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From Day 1 through Week 96|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833415|NCT00272779|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline in CD4 count among treated participants was determined.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.|||cells/mm^3||Standard Error|Mean
2833416|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline at Week 96|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter. log10 HIV RNA changes from baseline were summarized at Week 96 using observed values.|||c/mL||Standard Error|Mean
2833417|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL) at Week 96|HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.|||Participants|||Number
2833418|NCT00272779|Secondary|Number of Participants With HIV RNA < 50 c/mL) at Week 96|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.|||Participants|||Number
2833419|NCT00272779|Secondary|Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Week 48|The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833420|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|Baseline (Day 1) and Week 24|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Error|Mean
2833421|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 12.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
2833422|NCT00272779|Secondary|Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 4.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
2833423|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48|MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 48|Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
2833424|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24|Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 24.|As-treated participants with evaluable baseline MOS-HIV . The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.|||Units on Scale||Standard Error|Mean
2833425|NCT00272779|Secondary|Mean Change in Fasting Insulin at Week 48|Mean change from baseline in fasting insulin at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.|||micro units (µU)/mL||Standard Error|Mean
2833426|NCT00272779|Secondary|Mean Change in Fasting Glucose at Week 48|Mean change from baseline in fasting glucose at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.|||mg/dL||Standard Error|Mean
2833427|NCT00272779|Secondary|Mean Change in Fasting Lipid at Week 48|Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population.|||milligrams/deciliter (mg/dL)||Standard Error|Mean
2833428|NCT00272779|Secondary|Mean Change in Body Mass Index (BMI) in Participants at Week 48|Mean change in BMI from baseline at Week 48 was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.|||kg/m^2||Standard Error|Mean
2833429|NCT00272779|Secondary|Mean Change in Weight From Baseline at Week 48|Mean change in body weight from baseline was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.|||kg||Standard Error|Mean
2833467|NCT00271856|Secondary|Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging||3, 6, and 12 months|||||||
2833430|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833431|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48|Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833432|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833433|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833434|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833435|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833436|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833437|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)|Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833504|NCT00271544|Secondary|Model 4196 Lead Placement Time|Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
2833505|NCT00271544|Secondary|Fluoroscopy Time|Fluoroscopy time was defined as the total time the fluoroscope was imaging.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
2833438|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From baseline (Day 1) to Week 48.|Safety analyses of the treatment period are based on treated population.|||Participants|||Number
2833439|NCT00272779|Secondary|Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48|Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 48|Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Participants|||Number
2833440|NCT00272779|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|Mean change from baseline in CD4 cell counts was determined.|Baseline (Day 1) and Week 48.|All treated participants with data for this parameter.|||c/mm^3||Standard Error|Mean
2833441|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline to Week 48|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 48|All treated participants with data for this parameter.|||c/mL||Standard Error|Mean
2833442|NCT00272779|Secondary|Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)|TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population.|||Participants|||Number
2833443|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL at Week 48|HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers.|||Participants|||Number
2833444|NCT00272779|Primary|Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers.|||Participants|||Number
2833445|NCT00272337|Other Pre-specified|Change in Platelet Biomarkers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)|At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted.||||||
2833446|NCT00272337|Other Pre-specified|Change in Inflammatory Markers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)|At the conclusion of the trial in 2010, due to lack of funds for analysis, analysis was not conducted.||||||
2833447|NCT00272337|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months.|Heme oxygenase a downstream target of nitric oxide formation|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data|||ng/mL||Standard Deviation|Mean
2833448|NCT00272311|Other Pre-specified|Change in Platelet Biomarkers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)|At the end of the study due to lack of funds analysis of this data was not conducted.||||||
2833449|NCT00272311|Other Pre-specified|Change in Inflammatory Markers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)|At the end of the study, due to lack of funds, analysis of this outcome was not conducted.||||||
2833450|NCT00272311|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months|Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data|||ng/mL||Standard Deviation|Mean
2833451|NCT00272168|Primary|Employment Status|Data collected included from participants: weekly wages earned|Post Treatment (approximately 3 months after completion of the baseline assessment)||||dollars/week||Standard Deviation|Mean
2833452|NCT00272168|Primary|Social Functioning|"This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score.~Very Poor~Poor~Neither good nor poor~Somewhat good~Very good"|Post Treatment||||units on a scale||Standard Deviation|Mean
2833468|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
2833453|NCT00272168|Primary|Work Performance (Work Behavior Inventory)|"This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5:~Consistently an area Needing Improvement~Occasionally an area Needing Improvement~Performance Adequate in this area~Occasionally an area of Superior Performance~Consistently an area of Superior Performance.~The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study."|Post Treatment||||rating on a scale||Standard Deviation|Mean
2833454|NCT00272168|Secondary|Psychiatric Symptoms|Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).|Post-Treatment||||scores on a scale||Standard Deviation|Mean
2833455|NCT00272168|Secondary|Cognitive Insight|"Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows:~Do not agree at all~Agree slightly~Agree a lot~Agree completely~Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning."|Post Treatment||||units on a scale||Standard Deviation|Mean
2833456|NCT00272168|Primary|Employment Status|Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.|Post Treatment (approximately 3 months after completion of the baseline assessment)||||Hours worked per week||Standard Deviation|Mean
2833457|NCT00272038|Secondary|Time to Disease Progression|"Patients were evaluated for response biochemically and radiographically at each response assessment. RECIST 1.0 criteria were used for radiographic response. PSA measurement at a central laboratory was used to assess biochemical response. Patients must have had a baseline PSA of 5 ng/ml to be evaluated for PSA response. PSA was measured every 8 weeks.~For patients with measurable disease radiographically, PSA progression was not considered as having progressive disease. Refer to study publication for details."|25 months|29 participants enrolled. only 22 were evaluable, 4 withdrew consent, 2 had rapid PSA increase & 1 had cord compression|||months||Full Range|Median
2833458|NCT00272038|Secondary|Overall Survival|One year survival rate.|during study||||% of partcipants alive at one year|||Number
2833459|NCT00272038|Primary|Overall Clinical Benefit of Tarceva in CRPC.|Overall Clinical Benefit = percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).|5 years||||percentage of pts w/clinical benefit|||Number
2833460|NCT00271947|Primary|Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores|Clinical remission defined as a CDAI less than 150 and clinical improvement defined as decline in CDI> or = 70 one year following entry. The participant was not assessed according to the criteria of the outcome measure, because the participant was lost for follow-up.|baseline|||||||
2833461|NCT00271856|Primary|Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)|We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
2833462|NCT00271856|Primary|Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
2833463|NCT00271856|Primary|Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.|baseline to 12 months|ITT analyses|||scores on the scale||95% Confidence Interval|Mean
2833464|NCT00271856|Primary|Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)|Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
2833465|NCT00271856|Primary|Change in Depression as Measured by Beck Depression Inventory (BDI)|The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.|baseline to 12 months|ITT analyses.|||scores on the scale||95% Confidence Interval|Mean
2833469|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
2833470|NCT00271817|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
2833471|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
2833472|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Deviation|Median
2833473|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.|||Percent change||Standard Error|Mean
2833474|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline|baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Deviation|Median
2833475|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
2833476|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
2833477|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline|Baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.|||Percent change||Standard Error|Mean
2833478|NCT00271739|Primary|Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol||5 years||||mg/dL||Standard Error|Mean
2833479|NCT00271739|Primary|Blood Pressure Levels||5 years||||mmHg||Standard Error|Mean
2833480|NCT00271739|Primary|Hemoglobin A1c Levels||5 years||||A1c percentage||Standard Error|Mean
2833481|NCT00271609|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years||||Participants|||Number
2833482|NCT00271609|Primary|Percentage of Participants With Progression Free Survival at 6 Months.|Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.|6 months|at the time of data cutoff for this endpoint, 31 patients in the AG arm and 48 patients in the GBM arm were evaluable for PFS.|||Percentage of participants||95% Confidence Interval|Number
2833499|NCT00271544|Secondary|Electrical Performance -Tip Electrode: Pacing Impedance|Model 4196 lead tip electrode pacing impedance|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.|||Ohms||Standard Deviation|Mean
2833500|NCT00271544|Secondary|Electrical Performance - Tip Electrode: LV Voltage Threshold|Model 4196 lead tip electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.|||Volts||Standard Deviation|Mean
2833483|NCT00271596|Secondary|Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|||units on a scale||Standard Error|Least Squares Mean
2833484|NCT00271596|Secondary|Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Total Functional Capacity (TFC) subscale from the Unified Huntington's Disease Rating Scale (UHDRS). Definition: The TFC is a score that classifies five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. Construct Measured: Activities of Daily Living. Scale Range: The TFC score ranges from 0 to 13, where lower scores indicate poorer performance in activities of daily living. Change Calculation Details: Compares change in TFC performance from Baseline (week -4) to the weighted average of visits 4 (week 6) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing baseline (week -4) to the weighted average of Visits 4 (week 6) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833485|NCT00271596|Secondary|Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: Compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing screening (intake visit) to Visit 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833486|NCT00271596|Secondary|Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|"Full Scale Name: Trail Making Test Part B (TMT-B). Definition: The TMT-B test requires participants to connect-the-dots of 25 consecutive targets on a sheet of paper where the subject alternates between numbers and letters, going in both numerical and alphabetical order. Constructs Measured: Attention, set shifting, and processing speed. Scale range: The TMT-B score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort."|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833487|NCT00271596|Secondary|Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|"Full Scale Name: Stroop Interference subtest from The Stroop Color and Word Test. Definition: Participants are asked to name the ink color in which a word is printed when the word itself (which is irrelevant to the task) is the name of a different color rather than the same color. For example, participants may be asked to say red to the word blue printed in red ink. Constructs Measured: Selective attention, response inhibition, cognitive flexibility, and processing speed. Scale Range: The Stroop Interference score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort."|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833488|NCT00271596|Secondary|Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Verbal Fluency Score (VFC). Definition: The VFC is the number of words a person can produce given a letter, including (1) Naming words that start with F, A, and S; (2) naming words that start with K, W, and R; (3) naming words that start with V, I, and P; (4) naming words that start with O, G, and B; (5) naming words that start with E, N, and T; and (6) naming words that start with J, C, and S. Construct Measured: Verbal initiation and flexibility. Scale Range: The Verbal Fluency Composite Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in verbal initiation and flexibility from visit 2 (week 0) where patients named words starting with O, G, and B to the weighted average of visits 5 (week 12) and 6 (week 15) where patients named words starting with E, N, and T, and J, C, and S respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833501|NCT00271544|Secondary|Electrical Performance - Tip Electrode: Sensing|Model 4196 lead tip electrode R-wave amplitude|12-month|Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit.|||millivolt (mV)||Standard Deviation|Mean
2833502|NCT00271544|Secondary|Assessment of Lead Handling Characteristics|"Lead handling characteristics assessed as acceptable by physicians"|Implant|All available assessments from physicians.|||participants|||Number
2833489|NCT00271596|Secondary|Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Symbol Digit Modalities Test (SDMT). Definition: The SDMT screens for organic cerebral dysfunction by having the examinee use a reference key to pair specific numbers with given geometric figures in 90 seconds. Construct Measured: Attention, processing speed, and working memory. SDMT Scale Range: Raw scores may range from 0 to 110, where lower scores indicate poorer performance. Change Calculation Details: Compares change in performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833490|NCT00271596|Secondary|Semantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Semantic Fluency Score. Definition: The Semantic Fluency Score is the number of words a person can produce given a category, including naming (1) Animal names, (2) Fruit names, (3) Boy names, (4) Girl names, and (5) Vegetable names. Construct Measured: Working memory and verbal initiation. Scale Range: The Semantic Fluency Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on working memory tasks. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) where patients named fruit names to the weighted average of visits 5 (week 12) & 6 (week 15) where patients named girl names and vegetable names respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833491|NCT00271596|Secondary|Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Letter Number Sequencing (LNS) subtest from the Wechsler Adult Intelligence Scale (WAIS) third edition. Definition: LNS is a task that requires the reordering of an initially unordered set of letters and numbers. Construct Measured: Working memory. LNS Score Range: Raw scores may range from 0 to 21, where lower scores indicate poorer performance in working memory. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833492|NCT00271596|Primary|Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.|Full Scale Name: The Executive Composite Score (ECS). Definition: Subscales were averaged to compute this composite total score. The ECS is the weighted average of performance on 6 subtests of executive function, including (1) the Controlled Oral Word Association Test, (2) Symbol Digit Modalities test; (3) Stroop Color Word Test (Interference Trial), (4) Trail Making test (Part B), (5) Letter-Number Sequencing, and (6) Animal Naming. Construct Measured: Thinking tasks involving planning, working memory, attention, problem solving, verbal reasoning, inhibition, mental flexibility, and task switching. ECS Scale Range: The ECS score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on executive functioning tasks. Change Calculation Details: Compares change in executive functioning performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort|||units on a scale||Standard Error|Least Squares Mean
2833493|NCT00271570|Primary|Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion)|The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).|before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion.||||micogram*day/ml||Inter-Quartile Range|Median
2833494|NCT00271570|Primary|Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)|The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.|2 weeks||||events|||Number
2833495|NCT00271544|Secondary|Summarize All Adverse Events|All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|Up to 18 months|All subjects enrolled into the 4196 study.|||adverse events|||Number
2833496|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Pacing Impedance|Model 4196 lead ring electrode pacing impedance|12-Month|Subjects with Model 4196 lead implanted and completed 12-month visit.|||Ohms||Standard Deviation|Mean
2833497|NCT00271544|Secondary|Electrical Performance - Ring Electrode: LV Voltage Threshold|Model 4196 lead ring electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.|||Volts||Standard Deviation|Mean
2833498|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Sensing|Model 4196 lead ring electrode R-wave amplitude|Implant|Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant.|||mV||Standard Deviation|Mean
2833503|NCT00271544|Secondary|Total Implant Time|Total implant time was defined as time from initial incision to final closure.|Implant|Subjects successfully implanted with a Model 4196 lead.|||minutes||Standard Deviation|Mean
2833509|NCT00271544|Secondary|Subjects Successfully Implanted After Cannulation|A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects with successful CS cannulation after an incision was made (implant attempt)|||participants|||Number
2833510|NCT00271544|Primary|Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)|Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|Three Months|Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit.|||volts||Standard Deviation|Mean
2833511|NCT00271544|Primary|Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)|Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|One Month|Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit.|||volts||Standard Deviation|Mean
2833512|NCT00271544|Secondary|Subjects Successfully Implanted With Model 4196 Lead|A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects who underwent Model 4196 lead implant attempt.|||participants|||Number
2833513|NCT00271544|Primary|Safety (Subjects Without a Model 4196 Lead Related Complication)|A subject who was free of a Model 4196 lead related complication by one month visit.|One Month|Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit.|||participants|||Number
2833514|NCT00271375|Secondary|Perceived Social Support|Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833515|NCT00271375|Secondary|Personal Mastery|Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833516|NCT00271375|Secondary|Caregiver Efficacy|Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833517|NCT00271375|Secondary|Caregiver Mastery|Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Median
2833518|NCT00271375|Secondary|Caregiver Satisfaction|Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833519|NCT00271375|Secondary|Caregiver Burden|Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833520|NCT00271375|Secondary|Depressive Symptoms|Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form). The CES-D is a 10 Question Scale with total scores ranging from 0-30. Mean scores were calculated by finding the total sum divided by the total number of participants. Any score equal to or above 10 is considered depressed. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833535|NCT00271154|Secondary|Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)|The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.|Baseline to 12 months||||milliliters per meters squared||Standard Deviation|Mean
2833521|NCT00271375|Secondary|Physical Function|Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities). 10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833522|NCT00271375|Secondary|Physical Role Function|Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver. 4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833523|NCT00271375|Secondary|Subjective Health|Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago. Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up||||units on a scale||Standard Deviation|Mean
2833524|NCT00271375|Primary|"To Evaluate User Satisfaction With and Perceived Utility of the Caring for You, Caring for Me Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program"|This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.|18 Months|"User evaluation of the Caring for you, Caring for me education program. Data for participants in the Caring for you, Caring for me education program only and Caring for you, Caring for me education program+ Social Work were combined during data collection. Only 71 participants provided results. No data was collected from control group."|||participants|||Number
2833525|NCT00271219|Secondary|Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score|The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.|at delivery||||Score on the scale||95% Confidence Interval|Mean
2833526|NCT00271219|Secondary|Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)|Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.|from study entry until discontinuation or delivery (min=29 days, max=239 days)|intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy|||dose increase per trimester|||Number
2833527|NCT00271219|Secondary|Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of occurrence too low to be estimated with accuracy|||percentage of HIV risk behaviors|||Number
2833528|NCT00271219|Secondary|Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy|||percentage of drug use|||Number
2833529|NCT00271219|Primary|Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS|Total amount in mg|Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)||||mg||95% Confidence Interval|Mean
2833530|NCT00271219|Primary|Child's Peak Daily Total NAS Score|NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.|minimum twice daily from birth until NAS no longer measured (min=10 days)||||Score on the scale||95% Confidence Interval|Mean
2833531|NCT00271219|Primary|Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)|Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.|From birth until hospital discharge (min=4 days, max=10, depending on site)||||participants|||Number
2833532|NCT00271219|Primary|Child's Length of Hospital Stay||delivery until hospital discharge (min=2 days, max=79 days)||||days||95% Confidence Interval|Mean
2833533|NCT00271219|Primary|Child's Head Circumference Measurement (Measured at Birth)||birth||||cm||95% Confidence Interval|Mean
2833534|NCT00271154|Primary|Percentage of Patients Worsened for Clinical Composite Response|Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.|12 Months|All randomized patients were included using Intent to Treat (ITT).|||Percentage of participants worsened|||Number
2833581|NCT00270855|Primary|Glucose Effectiveness (Sg) Between Groups|Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
2842383|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48||||L||Standard Error|Mean
2833536|NCT00271102|Secondary|The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.||4 years|Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).||||||
2833537|NCT00271102|Primary|Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery|POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.|4 years|Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).||||||
2833538|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.|4-Weeks Post Quit Date (Study Week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.|||Participants|||Number
2833539|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.|1-Week Post Quit Date (Study Week 4)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.|||Participants|||Number
2833540|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|52 Weeks Following Smoking Quit Date (Study week 55)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
2833541|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|26 Weeks Following Smoking Quit Date (Study week 29)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
2833542|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
2833543|NCT00271024|Secondary|Weight Change at End of Treatment (Regardless of Quit Status)|Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.|Weight change at 12 weeks post quit date (study week 15) from smoking quit date|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome, regardless of their abstinence status at 12 weeks post quit date (study week 15)|||Pounds||Standard Error|Mean
2833544|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
2833545|NCT00271024|Primary|Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date|Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
2833546|NCT00271024|Secondary|Weight Change at End of Treatment (Smoking Abstinent Only)|Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.|Weight change at 12 weeks post smoking quit date (study week 15)|All participants completing through smoking quit date (study week 3) and who were smoking abstinent at end of treatment (study week 15)|||Pounds||Standard Error|Mean
2833547|NCT00271024|Primary|Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date|Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.|||Participants|||Number
2833548|NCT00271011|Secondary|Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events|The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. Since accrual was not completed the proportion of patients experiencing toxicities could not be statistically determined.||||||
2833582|NCT00270855|Primary|Insulin Sensitivity (Si) Between Groups|Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
2833549|NCT00271011|Primary|Percentage of Patients With an Objective Response|The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.||||||
2833550|NCT00270998|Secondary|Satisfaction With Treatment at 12 Months|"Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise."|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
2833551|NCT00270998|Secondary|Satisfaction With Treatment at 3 Months|"Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise."|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
2833552|NCT00270998|Secondary|75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months|Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
2833553|NCT00270998|Secondary|75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months|Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
2833554|NCT00270998|Secondary|No Bothersome Stress Incontinence Symptoms at 12 Months.|"Success if participants answer either no or yes with a bother component of not at all or somewhat to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise."|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
2833555|NCT00270998|Secondary|"Much Better or Very Much Better on PGI-I at 12 Months"|"PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. Participants were considered a success if they responded much better or very much better, or a failure if they responded otherwise."|Outcome was measured at 12 months following randomization.|If participant did not attend the 12-month follow-up, missing values were imputed as a failure.|||Participants|||Count of Participants
2833556|NCT00270998|Primary|No Bothersome Stress Incontinence Symptoms at 3 Months|"Success if participants answer either no or yes with a bother component of not at all or somewhat to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise."|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
2833557|NCT00270998|Primary|"Much Better or Very Much Better on PGI-I at 3 Months"|"PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. Participants were considered a success if they responded much better or very much better, or a failure if they responded otherwise."|Outcome was measured at three months following randomization.|If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.|||Participants|||Count of Participants
2833558|NCT00270894|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Measured from day 1 of treatment until time of death, assessed up to 48 months.||||Months||95% Confidence Interval|Median
2833559|NCT00270894|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.||||Months||95% Confidence Interval|Median
2833560|NCT00270894|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.|At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36|Note that the number of participants analyzed changes with the study interval. At Screening n=30, after Epirubicin/Cyclophosphamide n=30, Pre-surgery n=28, Follow-up Month 6 n=28, Follow-up Month 12 n=20, Follow-up Month 24 n=9, and Follow-up Month 36 n=1.|||LVEF percent||Standard Deviation|Mean
2833561|NCT00270894|Secondary|Clinical Response Prior to Surgery|Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters.|Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.|Clinical response assessment was available for 27 patients at the time of surgery.|||Participants|||Number
2837872|NCT00212888|Secondary|Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml||Up to week 48|Only participants who reached 10,000 copies/ml are included in the analysis.|||days||Inter-Quartile Range|Median
2833562|NCT00270894|Secondary|Pathologic Response|Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters.|At completion of neoadjuvant treatment period, up to 24 weeks.|28 patients went to surgery, so 28 patients were included in the surgery sample. Note that 4 patients in the pathologic complete response (pCR) group had residual ductal carcinoma in situ (DCIS).|||Participants|||Number
2833563|NCT00270894|Primary|Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities|Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.|Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.||||Events|Participants||Number
2833564|NCT00270894|Primary|Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule|Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.|From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)||||percentage of participants|||Number
2833565|NCT00270855|Other Pre-specified|Resting Metabolic Rate Between Groups|Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kcal/day||Standard Deviation|Mean
2833566|NCT00270855|Other Pre-specified|Change in Resting Metabolic Rate|Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kcal/day||Standard Deviation|Mean
2833567|NCT00270855|Secondary|Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups|Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Ratio||Standard Deviation|Mean
2833568|NCT00270855|Secondary|Total Cholesterol (TC) Between Groups|Comparison of TC between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833569|NCT00270855|Secondary|Low Density Lipoprotein Cholesterol (LDL) Between Groups|Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833570|NCT00270855|Secondary|High Density Lipoprotein Cholesterol (HDL) Between Groups|Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833571|NCT00270855|Secondary|Triglycerides Between Groups|Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833572|NCT00270855|Secondary|Lower Limb Bone Mineral Content Between Groups|Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||grams||Standard Deviation|Mean
2833573|NCT00270855|Secondary|Lower Limb Bone Mineral Density Between Groups|Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||g*(cm^2)^-1||Standard Deviation|Mean
2833574|NCT00270855|Secondary|Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)|Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Ratio||Standard Deviation|Mean
2833575|NCT00270855|Secondary|Change in Total Cholesterol (TC)|Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833576|NCT00270855|Secondary|Change in Low Density Lipoprotein Cholesterol (LDL)|Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833577|NCT00270855|Secondary|Change in High Density Lipoprotein Cholesterol (HDL)|Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833578|NCT00270855|Secondary|Change in Triglycerides|Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||mg/dL||Standard Deviation|Mean
2833579|NCT00270855|Secondary|Change in Lower Limb Bone Mineral Content|Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||grams||Standard Deviation|Mean
2833580|NCT00270855|Secondary|Change in Lower Limb Bone Mineral Density|Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||g*(cm^2)^-1||Standard Deviation|Mean
2833584|NCT00270855|Primary|Fat Mass Between Groups|Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||kg||Standard Deviation|Mean
2833585|NCT00270855|Primary|%Body Fat Between Groups|Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.|16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Percent Body Fat||Standard Deviation|Mean
2833586|NCT00270855|Primary|Change in Insulin Sensitivity (Si)|Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16-weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
2833587|NCT00270855|Primary|Change in Glucose Effectiveness (Sg)|Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16-weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||min^-1||Standard Deviation|Mean
2833588|NCT00270855|Primary|Change in Fat-Free Mass|Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Kg||Standard Deviation|Mean
2833589|NCT00270855|Primary|Change in Fat Mass|Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|Baseline, 16 Weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Kg||Standard Deviation|Mean
2833590|NCT00270855|Primary|Change in % Body Fat|Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.|baseline, 16 weeks|Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.|||Percent Body Fat||Standard Deviation|Mean
2833591|NCT00270842|Secondary|Fall Self Efficacy|Fall Self Efficacy is operationalized as perceived self efficacy (i.e. self confidence) for avoiding a fall during 10 global, relatively non-hazardous activities of daily living (getting dressed and undressed, for example). Fall self efficacy manifests itself with different degrees of fear of falling, each with a unique associated risk level. The MFES is simple, quick, easy-to-administer scale that assesses a patient's self-reported ability to perform, without falling, each of 14 common activities of daily living in a Likert scale format. Total scale ranges from 0 to 140, the higher score indicated more confidence in ability to manage a fall.|10 weeks||||units on a scale||Standard Deviation|Mean
2833592|NCT00270842|Primary|Gait and Balance Measures|The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject's ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.|10 weeks||||units on a scale||Standard Deviation|Mean
2833593|NCT00270790|Secondary|Response Rates Based on the Study Regimen|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.|||participants|||Number
2833594|NCT00270790|Primary|Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine|Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.|||participants|||Number
2833595|NCT00270634|Secondary|A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up.||Six months|Per Protocol Dataset|||Percentage of patients|||Number
2833596|NCT00270634|Secondary|Hypertension, Hyperlipidemia, or Hyperglycemia||Six months|Endpoint|||Percentage of patients|||Number
2833597|NCT00270634|Secondary|Graft Survival||Six months||||Percentage of patients|||Number
2833598|NCT00270634|Secondary|Patient Survival||Six months||||Percentage of patients|||Number
2833599|NCT00270634|Secondary|The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition|"A sparse sampling protocol of whole blood samples obtained on Day 180 at time points immediately prior to drug administration and at 1, 2, and 4 hours post‐dose were utilized.~Standard non‐compartmental analysis (NCA) was performed on whole blood concentration data for voclosporin and its metabolites, tacrolimus, MPA (mycophenolic acid) and MPAG (mycophenolic acid glucuronide). Tmax and Cmax were obtained directly from the concentration‐time profiles without interpolation. AUC(0‐4)[area under the curve] was calculated using log‐linear trapezoidal rule. Cmax, AUC(0‐4), C0 and C2 were summarized using descriptive statistics."|Six months|For subjects participating in the PK/PD portion of the study, a calcineurin sample was drawn prior to drug administration in order to assess baseline calcineurin levels. Blood samples were taken at Month 6 for the assessment of pharmacokinetics and pharmacodynamics. Participation by subjects was optional.|||% Calcineurin (CNi) compared to baseline||Standard Deviation|Mean
2833600|NCT00270634|Secondary|To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)|ANOVAs to test for differences in GFR at Month 6.|Six months|Standard deviation around Iothalamate GFR made results uninterpretable, therefore Nankivell GFR was reported as it was collected a priori.|||mL/min||Standard Deviation|Mean
2833601|NCT00270634|Primary|Biopsy Proven Acute Rejection (BPAR)|The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.|Six months||||percentage of participants|||Number
2833602|NCT00270296|Primary|Number of HIV+ Infants|Number of infants with HIV-positive status|Throughout study, including breastfeeding, assessed up to 24 months|Analysis is based on actual number of available patients, and may not perfectly match the Patient Flow module.|||Infants|||Number
2833603|NCT00270296|Primary|Number of Participants With Virologic Suppression|Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter|Throughout study, including breastfeeding, assessed up to 24 months||||Participants|||Count of Participants
2833604|NCT00270257|Secondary|Incident Hepatitis B Infections|Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.|Measured through week 52||||participants with HBsAg|||Number
2833605|NCT00270257|Secondary|Incident Hepatitis C Infections for Thailand and China|"HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.~If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).~Analysis was done separately for both countries"|Measured through week 156 in Thailand and 104 weeks in China|Baseline HCV antibody negative participants.|||participants with HCV antibody|||Number
2833606|NCT00270257|Secondary|Self-reported Number of Injections in the Last Month||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.|||injections||Inter-Quartile Range|Median
2833607|NCT00270257|Secondary|Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.|||participants|||Number
2833608|NCT00270257|Secondary|Self-report of Continued Injection Opiate Use in the Last 30 Days|All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.|Measured through Week 104|Number of participants presented here applies to whom data available at week 104.|||participants|||Number
2833609|NCT00270257|Secondary|Number of Participants With Urinalysis Results Positive for Opiates|Urine drug screen were assessed monthly and semiannually.|Measured through Week 104|Number of participants presented here applies to visit 104 for whom data available.|||participants|||Number
2833610|NCT00270257|Primary|Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks|The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect.|For visits up to week 104|Data Safety Monitoring Board (DSMB) halted the study on October 4, 2011 due to futility as a result of lower than anticipated HIV incidence rates. See participant flow section for the number of participants who completed visit up to 104 by July 31, 2012.|||participants|||Number
2833611|NCT00270231|Primary|Number of Nicotine Cigarette Choices Taken During the Cigarette Choice Procedure.|"On day 4 of each study medication period, participants completed a cigarette choice procedure where the subject is asked to take 4 puffs from a nicotinized (nicotine-containing) or a denicotinized (no nicotine) cigarette every 30 minutes for 2 hours (maximum of 24 puffs). The outcome variable is the number of nicotine cigarette choices or puffs out of 24 total puffs during these cigarette choice procedures.~Subjects who had the A/A genotype took an average of 18.5 puffs from the nicotine-containing cigarettes. Subjects with the A/G or G/G genotypes took an average of 16.2 puffs from the nicotine-containing cigarettes."|2 hours|Participants were analyzed with respect to genotype regardless of intervention.|||Number of Nicotine Cigarette Puffs Taken||Standard Deviation|Mean
2833612|NCT00270205|Other Pre-specified|Breadth of HIV-1-specific Immune Response, as Determined by the Number of Overlapping HIV-1 Peptides for Which the ELISPOT Assay for IFN-gamma Production is Observed to Have Five or More Spot-forming Cells/ 10^5 PBMCs|Additional outcome measure for possible supportive exploratory analysis. The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.|From start of study vaccination to week 24|There are no data available for the analysis.||||||
2833613|NCT00270205|Secondary|Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens|The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.|From start of study vaccination to week 24|There are no data available for the analysis.||||||
2833614|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833615|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833741|NCT00268463|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study||Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy|||||||
2833616|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833617|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833618|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833619|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833620|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833621|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833622|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||percent||Inter-Quartile Range|Median
2833623|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||percent||Inter-Quartile Range|Median
2833624|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833625|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833664|NCT00269113|Secondary|Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months|Time to next treatment was defined as the interval from randomization date to the time when new treatment was needed. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
2833626|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833627|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833628|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||percent||Inter-Quartile Range|Median
2833629|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to anti-CD3 antigen were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833630|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to whole HIV-1 antigen were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833631|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.|||cells/mm3||Inter-Quartile Range|Median
2833632|NCT00270205|Secondary|Anti-dsDNA Antibody Response|Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.|From start of study vaccination to week 61|All participants who started study vaccination and who have anti-ds DNA results at baseline and week 17 or 61 were included in the analysis.|||participants|||Number
2833633|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
2833634|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs across gag p17, gag p24, gag 15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
2833635|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen as detected by the PHPC assay. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
2833665|NCT00269113|Secondary|Response Duration - Percentage of Participants Event Free at 24 Months|Response duration defined as interval from first assessment of CR/PR to PD. PD is an increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
2833636|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs detected by the PHPC (precursors with high proliferative capacity) assay across gag p17, gag p24, gag p15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.|||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
2833637|NCT00270205|Secondary|Time-averaged AUC of CD8+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD8+ T-cell count responses was used to characterize each participant's overall CD8+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD8+ T-cell count responses at all study visits were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2833638|NCT00270205|Secondary|Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD4+ T-cell count responses was used to characterize each participant's overall CD4+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD4+ T-cell count responses at all study visits were included in the analysis.|||cells/mm3||Inter-Quartile Range|Median
2833639|NCT00270205|Primary|Percent of Participants With Primary Safety Endpoint|Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely attributed to an allergic reaction to the adhesive of the tape used to adhere the vaccination patch to the skin and not the vaccine itself were not used in determination of the primary safety endpoint.|From start of study vaccination to 28 days after the last study vaccination|Only those participants who started study treatment/vaccination were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2833640|NCT00269919|Secondary|Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of risperidone long acting injection (RLAI). Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
2833641|NCT00269919|Secondary|Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score for each person at each time is the positive score minus the negative score.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2833642|NCT00269919|Secondary|Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score|"The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of red herrings to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating."|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of RLAI. Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.|||Unit on a scale||Standard Deviation|Mean
2833643|NCT00269919|Secondary|Change From Baseline in NCFT: TMT-Error at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."|||Errors||Standard Deviation|Mean
2833644|NCT00269919|Secondary|Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."|||Seconds||Standard Deviation|Mean
2837873|NCT00212888|Secondary|Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group||Up to week 48||||days||Inter-Quartile Range|Median
2833645|NCT00269919|Secondary|Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96|MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."|||MQ||Standard Deviation|Mean
2833646|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96|The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2833647|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96|The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for 'words recalled' is 15, which represents better episodic memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.|||Words recalled||Standard Deviation|Mean
2833648|NCT00269919|Secondary|Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96|The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure.|||Words generated per min||Standard Deviation|Mean
2833649|NCT00269919|Secondary|Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96|The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.|||Intelligence quotient (IQ)||Standard Deviation|Mean
2833650|NCT00269919|Secondary|Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96|The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2833651|NCT00269919|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96|GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2833723|NCT00268983|Secondary|Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||10^3/microliter (µL)||Full Range|Median
2833652|NCT00269919|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96|The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2833653|NCT00269919|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96|The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.|Baseline and Week 96|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 efficacy measurement post-baseline. Here, ‘N'=the participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2833654|NCT00269633|Primary|Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks|Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.|Averaged over Three Weeks During Treatment||||units on a scale||Standard Deviation|Mean
2833655|NCT00269477|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions|Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
2833656|NCT00269477|Primary|Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination.~Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination."|28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)|SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Participants|||Number
2833657|NCT00269399|Secondary|Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success|Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.|42 days|Participants included in this analysis were restricted to those who experienced initial clinical success at the TOC Visit following the 10-day Treatment Phase.|||Participants|||Count of Participants
2833658|NCT00269399|Primary|Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.|"Resolution or improvement of baseline signs and symptoms was assessed as~Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1);~Absence of fever (< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and~3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit."|14 days|Modified Intent-to-Treat (MITT) population included all randomized subjects who had acute diarrhea and with a positive C. difficile stool toxin assay within ± 48 hours of screening and received at least one dose of study drug.|||Participants|||Count of Participants
2833659|NCT00269152|Secondary|Overall Survival at 6 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|Baseline to date of death from any cause assessed at 6 years|All randomized participants. Intent to treat population.|||percent probability of survival (%)||95% Confidence Interval|Number
2833660|NCT00269152|Secondary|3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.|length of time disease free, assessed at 3 years|All randomized participants. Intent to Treat population.|||probability of disease-free survival (%)||95% Confidence Interval|Number
2833661|NCT00269152|Secondary|Overall Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|baseline to date of death from any cause, assessed at 3 years|All randomized participants. Intent to treat population.|||percent probability of survival (%)||95% Confidence Interval|Number
2833662|NCT00269152|Secondary|Grade III/IV Adverse Events|Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.|every 21-day cycle for 4 cycles|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).|||participants|||Number
2833663|NCT00269152|Primary|The Feasibility of Post-Surgery Chemotherapy|Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.|every 21-day cycle for 4 cycles up to 30 days after last infusion|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).|||participants|||Number
2833666|NCT00269113|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months|DFS was defined as the interval from first assessment of CR to PD. PD is an increase in the frequency and severity of disease symptoms, the occurrence of new nodal or extranodal lymphoma manifestations, the volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
2833667|NCT00269113|Secondary|Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months|EFS was defined as the interval from randomization date to therapy failure. Therapy failure was defined after 2 cycles as no change (NC) or progression of disease (PD); after 6 cycles as minimal response [MR], NC, or PD); or death from any cause. NC is defined as tumor regression of <25%, stable disease and progression ≤25%. PD was defined as the increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, and increase of splenomegaly by more than 25%. MR was defined as tumor regression between 50% (<50%) and 25% (≥25%) for at least 4 weeks without occurrence of new manifestations. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
2833668|NCT00269113|Secondary|Overall Survival (OS) - Percentage of Participants Alive at 24 Months|OS was defined as interval from randomization to date of death of any cause. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population|||percentage of participants|||Number
2833669|NCT00269113|Secondary|Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months|PFS was defined as the interval from randomization date to progression of disease or death from non-Hodgkin's Lymphoma (NHL). Progression of disease was defined as: increase in the frequency and severity of disease symptoms; occurrence of new nodal or extranodal lymphoma manifestations; volume increase of pre-existing lymphoma manifestations by more than 25%; or increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha equals (=) 5% for difference between the treatment groups.|24 months|ITTcbcc/FL Population|||percentage of participants|||Number
2833670|NCT00269113|Primary|Percentage of Participants Achieving CR or PR at the End of Therapy|CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks. This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10^9/L), hemoglobin (Hb) >7.5 millimoles per liter (mmol/L), and platelets less than (<) 100 Gpt/L. PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.|Following completion of 6 cycles (24 weeks)|The ITT centroblastic-centrocytic (cbcc)/Follicular Lymphoma (FL) (collectively, ITTcbcc/FL) population included all participants in the ITT population with cbcc lymphoma (target population).|||percentage of participants||95% Confidence Interval|Number
2833671|NCT00269087|Secondary|Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol|For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.|Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours|All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.|||Hours*picogram per milliliter||Standard Deviation|Mean
2833672|NCT00269087|Secondary|Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP|For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.|Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours|All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.|||Hours*picogram per milliliter||Standard Deviation|Mean
2833673|NCT00269087|Secondary|Median Tmax of Salmeterol|For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.|Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours|All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.|||hour||Full Range|Median
2833674|NCT00269087|Secondary|Median Time of Observed Maximum Plasma Concentration (Tmax) of FP|For analysis of PK parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.|Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours|All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.|||hours||Full Range|Median
2833724|NCT00268983|Secondary|Hematologic Nadir for Hemoglobin|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||Grams per deciliter (G/dL)||Full Range|Median
2833675|NCT00269087|Secondary|Mean Cmax of Salmeterol|For analysis of PK parameters for salmeterol, blood samples were taken just before dosing (within one hour prior to dosing), 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.|Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours|All evaluable subjects. Only those participants with data available at the indicated time points were analyzed.|||pg/mL||Standard Deviation|Mean
2833676|NCT00269087|Secondary|Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP)|For analysis of pharmacokinetic (PK) parameters for FP, blood samples were taken just before dosing (within one hour prior to dosing), 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours after dosing to determine plasma drug concentrations. The investigational product was taken in fasting condition just before each blood sampling. Parameters were calculated by a model-independent method with the plasma concentration-time profile data in individual participants.|Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours|All participants evaluable for pharmacokinetic parameters were included in PK Population. Only those participants with data available at the indicated time points were analyzed.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
2833677|NCT00269087|Secondary|Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|An exacerbation was defined as worsening of the participant's symptoms of cough, sputum production and breathlessness requiring a change in medication. When a moderate or severe COPD exacerbation was observed, details (date of onset, outcome, date of resolution/death, severity, medications provided for treatment, whether the COPD exacerbation required hospitalization, whether the COPD exacerbation required participant withdrawal from the study) were recorded.|Up to Week 56|FAS Population.|||Number of exacerbations||Standard Deviation|Mean
2833678|NCT00269087|Secondary|Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings|A participant recorded scores on the scale of 0 to 4 for breathlessness and nighttime awakenings, where 0 indicated no symptoms and 4 indicated severe symptoms; on the scale of 0 to 3 for cough and sputum production, where 0 indicated no symptoms and 3 indicated severe symptoms, in the 24 hours prior to each entry in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit2. Change from Baseline was any post Baseline value minus Baseline value.|Baseline and up to Week 52|FAS Population|||Scores on a scale||Standard Deviation|Mean
2833679|NCT00269087|Secondary|Mean Change From Baseline in Percent of Days Without Use of Rescue Medication|Rescue medication (salbutamol sulfate aerosol provided as an investigational product) was issued to a participant and, when necessary, a spacer at the start of the run-in period. At each time of entry in the Chronic Obstructive Pulmonary Disease (COPD) diary, a participant recorded the number of occasions of rescue medication inhaled in the previous 24 hours in the COPD diary. Baseline was mean value of the consecutive 7 days just before Visit 2. Change from Baseline was any post Baseline value minus Baseline value.|Baseline and up to Week 52|FAS Population.|||Percentage of days||Standard Deviation|Mean
2833680|NCT00269087|Secondary|Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity|V25 and V 50 were measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as baseline. Change from Baseline was any post Baseline value minus Baseline value.|Baseline and up to Week 52|FAS Population. Only those participants available at the specified time points were analyzed.|||Liter per second||Standard Deviation|Mean
2833681|NCT00269087|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC)|FVC was the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as Baseline. Change from Baseline was any post Baseline value minus Baseline value.|Baseline and up to Week 52|FAS Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Deviation|Mean
2833682|NCT00269087|Secondary|Mean Change From Baseline in Peak Expiratory Flow (PEF)|PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. Baseline value was the value measured at visit 2. However, when the value at Visit 2 was missing, the value at Visit 1 was used as Baseline. Change from Baseline was any post Baseline value minus Baseline value.|Baseline and up to Week 52|Full analysis set (FAS) Population included all enrolled Population excluding those who had not received investigational product at all and those who had no available data regarding efficacy after starting treatment with investigational product. Only those participants available at the specified time points were analyzed.|||Liters per second||Standard Deviation|Mean
2833683|NCT00269087|Secondary|Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings|On each assessment day at Week 24, 52 and follow up, ophthalmological examinations (vision, cornea, lens, intraocular pressure, fundus oculi) were performed to determine the presence or absence of glaucoma and cataract.|Up to Week 56|Safety Population|||Participants|||Count of Participants
2833684|NCT00269087|Secondary|Mean Change From Baseline in Weight|Body weight was measured during run-in period, at Week 24 and 52.|Baseline and up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Deviation|Mean
2833725|NCT00268983|Secondary|Hematologic Nadir for Absolute Neutrophil Count|Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population excluding participants that did not have data within the 120 days of study drug administration.|||10^3/cubic millimeter (mm^3)||Full Range|Median
2833685|NCT00269087|Secondary|Mean Change From Baseline in Bone Mineral Density (BMD)|On each assessment day at Week 52 and follow up, lumber (L1-L4) BMD was determined with a BMD meter by the dual energy X-ray absorption (DEXA) method. Baseline value was the measurement taken during run-in period. Change from Baseline was any value post Baseline minus value at Baseline.|Baseline and up to Week 56|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Grams per centimeter square||Standard Deviation|Mean
2833686|NCT00269087|Secondary|Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings|On each assessment day at Week 24, 52 and follow up 12-lead ECG was performed. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance.|Up to Week 56|Safety Population.|||Participants|||Count of Participants
2833687|NCT00269087|Secondary|Number of Participants With Abnormal Oropharyngeal Examination Findings|Oropharyngeal examination was performed in participants with suspected oral infection (candidiasis).|Up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2833688|NCT00269087|Secondary|Mean Change From Baseline in Pulse Rate|Pulse rate was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.|Baseline and up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||beats per min||Standard Deviation|Mean
2833689|NCT00269087|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Systolic and diastolic BP was measured in sitting position. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.|Baseline and up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2833690|NCT00269087|Secondary|Mean Level of Plasma Cortisol 2|On each assessment day at Week 24, 52 and follow up, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry.|Up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||µg/dL||Geometric Coefficient of Variation|Geometric Mean
2833691|NCT00269087|Secondary|Mean Change From Baseline in Level of Plasma Cortisol 1|On each assessment day at Week 24 and 52, adrenal cortical function tests were performed between 8:00-10:00 in the morning. Additional measurements were taken at follow up visit, if the measurements made at Week 52 revealed any abnormalities of clinical significance. Blood samples were taken from participants at rest before undergoing spirometry. Baseline value was the measurement taken at the start of run-in or the treatment period. Change from Baseline was any post Baseline value minus value at Baseline.|Baseline and Week 24 and 52|Safety Population. Only those participants available at the specified time points were analyzed.|||Micrograms per decilitre (µg/dL)||Standard Deviation|Mean
2833692|NCT00269087|Secondary|Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters|Urinalysis parameters: Urine protein, Glucose and Urobilinogen were presented as shift from Baseline. Only number of participants with urinalysis values more than Baseline values were presented. The plus sign increases with a higher level of glucose and proteins in the urine: 1+: slightly positive, 2+: positive, 3+: high positive and 4+: strongly positive.|Up to Week 56|Safety Population|||Participants|||Count of Participants
2833693|NCT00269087|Secondary|Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters|Clinical chemistry parameters: Total bilirubin (TB), Alkaline phosphatase (Al-P), Alanine aminotransferase (ALT), Asparate aminotransferase (AST), Gamma-glutamyl transpeptidase (GTP), Lactate dehydrogenase (LDH), Total cholesterol (TC), Glucose, Creatinine, Blood urea nitrogen (BUN), Uric acid (UA), Sodium (Na), Potassium (K), Chloride (Cl) and Calcium (Ca) were presented as the outliers from the normal range as > upper limit and < lower limit. Only number of participants with clinical chemistry values outside normal range were presented.|Up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2833694|NCT00269087|Secondary|Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters|Hematology parameters: Red blood cells (RBC), Hemoglobin (Hb), Hematocrit, Platelet count (PC), White blood cells (WBC), Basophils, Eosinophils, Neutrophils, Lymphocytes and Monocytes were presented as the outliers from the normal range as > upper limit and < lower limit. Only number of participants with hematology values outside normal range were presented.|Up to Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2833695|NCT00269087|Primary|Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Week 56|Safety Population included all participants who had received an investigational product even for once.|||Participants|||Count of Participants
2833696|NCT00268996|Secondary|Change From Baseline in Fibrous Tissue and Fibro-fatty as a Percent of IVUS-VH Plaque as IVUS-VH Assessments at Week 52|Fibro-fatty as percentage of VH plaque and Fibrous tissue as percentage of VH plaque were derived from IVUS-VH system. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as Fibro-fatty as percentage of VH plaque or Fibrous tissue as percentage of VH plaque at Week 52 minus baseline value. The data was reported based on observed cases. Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||Percentage of VH||Standard Error|Least Squares Mean
2833697|NCT00268996|Secondary|Change From Baseline in Fibrous Tissue Volume and Fibro-fatty Volume as IVUS-VH Assessments at Week 52|"Change from baseline in fibrous tissue volume and fibro-fatty volume were derived from IVUS system at each IVUS grey scale assessment recorded. Fibrous tissue volume was calculated as mean fibro-fatty area multiplied by mean of Baseline and Follow-up length. Fibro-fatty volume was calculated as mean fibrous area multiplied by mean of Baseline and Follow-up length.~The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as mean Fibrous tissue volume or Fibro-fatty volume at Week 52 minus baseline value. The data was reported based on observed cases. Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates."|Baseline and Week 52|Imaging evaluable population|||mm^3||Standard Error|Least Squares Mean
2833698|NCT00268996|Secondary|Change From Baseline in Mean Plaque Area, Mean Vessel Area, and Mean Lumen Area as IVUS-Grey Scale Assessments at Week 52.|Change from baseline in was mean plaque area, mean vessel area, and mean lumen area were derived from IVUS system at each IVUS grey scale assessment recorded. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as mean area of the parameter (plaque/vessel/lumen) at Week 52 minus baseline value. The data was reported based on observed cases. Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||mm2||Standard Error|Least Squares Mean
2833699|NCT00268996|Secondary|Change From Baseline in Vessel Volume and Lumen Volume as IVUS-Grey Scale Assessments at Week 52.|Change from baseline in vessel volume and lumen volume calculated for each IVUS grey scale assessment recorded. Vessel volume (i.e., coronary remodelling) defined by the leading edge of echogenic adventitia/external elastic membrane (EEM) and calculated as, mean vessel area multiplied mean of vessel length at Baseline and Follow-up. Lumen volume was circumscribed by the leading edge of intima/plaque and calculated as mean lumen area multiplied by mean lumen length at Baseline and Follow-up. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline was calculated as vessel volume or lumen volume at Week 52 minus baseline value.|Baseline and Week 52|Imaging evaluable population|||mm^3||Standard Error|Least Squares Mean
2833700|NCT00268996|Secondary|Mean Levels of Oxidized Non-esterified Fatty Acids (Ox-NEFA) as Target Circulating Biomarkers at the End of Week 26 and Week 52|Mean ox-NEFA levels as circulating biomarkers associated with Lp-PLA2 target-related biomarkers at Week 26 and Week 52 was planned to be assessed. However, the parameter data were not collected for this endpoint.|Week 26 and Week 52|Biomarker evaluable population||||||
2833701|NCT00268996|Secondary|Mean Levels of Oxidised Phospholipids/ Apolipoprotein B100 (oxPL/apoB) Ratio as Target Circulating Biomarkers at the End of Week 26 and Week 52.|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean OXPL/LAPO B levels as circulating biomarkers associated with Lp-PLA2 target-related biomarkers at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. OXPL/LAPO B had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of OXPL/LAPO B levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population.|||Relative light units (RLU)||95% Confidence Interval|Geometric Mean
2833702|NCT00268996|Secondary|Mean Matrix Metaloproteinases-9 (MMP-9) Levels as Circulating Biomarkers Associated With Plaque Instability at Week 26 and Week 52.|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean MMP-9 levels as circulating biomarkers associated with plaque instability at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward MMP-9 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of MMP-9 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population|||microgram per litre (mcg/L)||95% Confidence Interval|Geometric Mean
2833703|NCT00268996|Secondary|Mean sCD40L Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean sCD40L levels as circulating biomarker associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. sCD40L had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of sCD40L levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Safety Population comprised of all randomized participants who received at least one dose of study drug. Only those participants with data available at the indicated time points were analyzed.|||pg/ml||95% Confidence Interval|Least Squares Mean
2833704|NCT00268996|Secondary|Mean Myeloperoxidase (MPO) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean MPO levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. MPO had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of MPO levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population|||picomole per litre (pmol/L)||95% Confidence Interval|Geometric Mean
2833726|NCT00268983|Secondary|Time to Next Treatment|Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||||||
2833742|NCT00268463|Secondary|Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms||Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy|||||||
2833705|NCT00268996|Secondary|Mean Intercellular Adhesion Molecule-1 (ICAM-1) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean ICAM-1 levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. ICAM-1 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of ICAM-1 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population.|||nanogram per millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
2833706|NCT00268996|Secondary|Mean Interlukin 6 (IL-6) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52|Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean IL-6 levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. IL-6 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of IL-6 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26 and Week 52|Biomarker evaluable population|||Nanograms per litre (ng/L)||95% Confidence Interval|Geometric Mean
2833707|NCT00268996|Secondary|Change From Baseline in Necrotic Core as a Percent of IVUS-VH Plaque at the End of Week 52.|Change from baseline was calculated for each IVUS-VH assessment recorded at the end of study. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline in percent necrotic core was calculated as percent necrotic core at Week 52 minus baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates. Change from Baseline in necrotic core as a percent of IVUS-VH plaque at the end of week 52 was reported.|Baseline and Week 52|Imaging evaluable population|||Percent Necrotic core||Standard Error|Least Squares Mean
2833708|NCT00268996|Secondary|Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52|Change from Baseline was calculated for each IVUS-VH assessment recorded at the end of study. The necrotic core volume was calculated as mean necrotic area multiplied by mean of Baseline and follow-up length. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, Baseline value, matched segment length and treatment included as covariates. The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline in necrotic core volume as IVUS-VH assessments at Week 52 was reported.|Baseline and Week 52|Imaging evaluable population. Only those participants with data available at the indicated time points were analyzed.|||mm^3||Standard Error|Least Squares Mean
2833709|NCT00268996|Secondary|Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52|Change from Baseline in percent obstruction volume was calculated for each IVUS grey scale assessment recorded. Percent obstruction volume was calculated as (Plaque volume/ Vessel volume *100). The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||Percentage of mm^3||Standard Error|Least Squares Mean
2833710|NCT00268996|Secondary|Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52|Change from Baseline was calculated for each IVUS grey scale assessment recorded at the end of study. The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, Baseline value, matched segment length and treatment included as covariates.|Baseline and Week 52|Imaging evaluable population|||Cubic millimetre (mm^3)||Standard Error|Least Squares Mean
2833711|NCT00268996|Secondary|Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52|Lp-PLA2 is a calcium-independent phospholipase A2 enzyme associated with low density lipoprotein (LDL) in plasma. Blood samples were collected at baseline and at Week 4, 13, 26, and 52 and Lp-PLA2 activity was determined. Percentage inhibition of Lp-PLA2 activity relative to baseline was calculated as, percent inhibition = ([baseline value - post baseline value] x 100) / baseline value. The baseline value for each participant was defined as the last value prior to the first dose of study drug.|Week 26 and Week 52|The biomarker evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable biomarker assessment at 3 months (Day 77) or later.|||micromole per minute per Litre||95% Confidence Interval|Geometric Mean
2833712|NCT00268996|Secondary|Circulating Hs-CRP at the End of Week 26.|hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. LOCF data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 26 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.|Week 26|Biomarker evaluable population|||mg/L||95% Confidence Interval|Geometric Mean
2833727|NCT00268983|Secondary|Number of Participants Who Had Died by the Month Indicated|The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||participants|||Number
2833743|NCT00268463|Secondary|Survival as Measured by Time to Death From Any Cause.||Time from randomization through year 5|||||||
2833744|NCT00268463|Secondary|Liver PFI as Measured by Time to Hepatic Progression.||Time from randomization through year 5|||||||
2833745|NCT00268463|Primary|Progression-free Interval (PFI)|Time to first recurrence of colon cancer at any site|Time from randomization through year 5|||||||
2833713|NCT00268996|Primary|Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52.|The ROC grade III/IV strain spots per 10 millimetre (mm) within the ROI on intravascular ultrasound (IVUS) grey scale based palpography were assessed and change from Baseline at end of 52 was reported. Change from Baseline was calculated as the density of spots at the end of study minus the density of spots recorded at Baseline. If either value was considered missing then the change from Baseline value was missing for the participant. Between treatment group comparisons of change from Baseline were analyzed using ANCOVA adjusting for ACS status, pooled country, Baseline value, matched segment length and treatment. Adjusted means and associated standard errors for each treatment group were presented. The baseline value for each participant was defined as the last value prior to the first dose of study drug.|Baseline and Week 52|The imaging evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable baseline and end of treatment imaging assessment at 6 months (Day 154) or later. The participants available at the time of assessment were included in the analysis.|||Spots/10 mm||Standard Error|Least Squares Mean
2833714|NCT00268996|Primary|Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52.|hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. Last Observation Carried Forward (LOCF) data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 52 were reported. The levels were analyzed using analysis of co-variance (ANCOVA), with Acute Coronary Syndrome (ACS) status, pooled country and treatment included as covariates.|Week 52|The biomarker evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable biomarker assessment at 3 months (Day 77) or later.|||mg per litre (mg/L)||95% Confidence Interval|Geometric Mean
2833715|NCT00268983|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|From randomization through Week 26|ITT-Exposed Population|||Participants|||Number
2833716|NCT00268983|Secondary|Number of Participants With Myelodysplasia/Leukemia|The cumulative incidence of myelodysplasia/leukemia was estimated.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||Participants|||Number
2833717|NCT00268983|Secondary|Number of Hospitalizations|The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.|Time of treatment until 90 days post-treatment|ITT-Exposed Population||||||
2833718|NCT00268983|Secondary|Number of Participants With an Infusion Reaction|An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|First 24 hours of study drug administration.|ITT-Exposed Population|||participants|||Number
2833719|NCT00268983|Secondary|Number of Participants That Developed Hypothyroidism|Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||Participants|||Number
2833720|NCT00268983|Secondary|Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters|Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population. Participants with a Grade 3/4 toxicity level for the indicated hematological parameters were analyzed (reflected by n=X, X). Different participants may have been analyzed for different parameters; thus, the overall number analyzed reflects everyone in the ITT-Exposed Population.|||Days||Full Range|Median
2833721|NCT00268983|Secondary|Time to Recovery to Baseline Grade for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||Days||95% Confidence Interval|Median
2833722|NCT00268983|Secondary|Time to Nadir Values for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||Days||Standard Deviation|Mean
2833728|NCT00268983|Secondary|Time to Death|"Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled Number of Participants Who Had Died by the Month Indicated for data regarding time to death."|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||months||95% Confidence Interval|Median
2833729|NCT00268983|Secondary|Duration of Response|Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population. Only those participants with confirmed or unconfirmed complete response or partial response were analyzed for duration of response.|||months||95% Confidence Interval|Median
2833730|NCT00268983|Secondary|Number of Participants Achieving Response|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population|||Participants|||Number
2833731|NCT00268983|Primary|Progression-free Survival|Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population|||months||95% Confidence Interval|Median
2833732|NCT00268983|Primary|Event-free Survival (EFS)|Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|Intent-to-Treat (ITT)-Exposed Population: all participants who received at least one dose of treatment|||Months||95% Confidence Interval|Median
2833733|NCT00268905|Secondary|Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD).|From start of eribulin treatment until disease progression or death|Efficacy Evaluable Population|||percentage of subjects|||Number
2833734|NCT00268905|Secondary|Safety of Eribulin Mesylate in Combination With Carboplatin as Measured by the Number of Subjects With Treatment Emergent Adverse Events.|Adverse events were considered treatment emergent if they started on or after the date of administration of the first dose of study drug, or if they were present prior to the administration of the first dose of study drug and increased in severity during the study.|Throughout the entire study|Safety Evaluable Population|||participants|||Number
2833735|NCT00268905|Primary|Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.|MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.|21 days (first cycle)||||mg/m^2|||Number
2833736|NCT00268892|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|4.5 years||||participants|||Number
2833737|NCT00268892|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline and up to 4.5 years|The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.|||participants|||Number
2833738|NCT00268762|Secondary|Arterial Complete Recanalization at 24 Hours Post tPA Bolus|Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.|24 hours from tPA bolus||||percent of patients|||Number
2833739|NCT00268762|Secondary|Arterial Complete Recanalization at 2 Hours Post tPA Bolus|Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.|2 hours complete recanalization post tPA bolus||||percent of patients|||Number
2833740|NCT00268762|Primary|Symptomatic and Radiographic Intracerebral Hemorrhage|"Significant intracerebral hemorrhage as defined by either:~Symptomatic intracerebral hemorrhage or~Parenchymal hematoma type 2."|Within 7 days of enrollment||||percentage of patients||95% Confidence Interval|Number
2833746|NCT00268450|Secondary|Rate of Post-operative Complications||from first treatment until up to 48 hours after surgery.|Data for this outcome measure was not collected||||||
2833754|NCT00268437|Primary|Pathologic Complete Response Rate|The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.|Baseline to time of surgery (around 10 - 18 weeks post-baseline)||||percentage of participants||95% Confidence Interval|Number
2833755|NCT00268346|Primary|The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.|The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.|at 8 weeks after initiation of treatment|All patients enrolled were analyzed|||participants|||Number
2833756|NCT00268242|Secondary|Percentage of Patients Making it to Bone Marrow Transplant.|Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment.|After completion of protocol therapy||||percentage of Patients completed a BMT|||Number
2833757|NCT00268242|Primary|Duration of the First Complete Response||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|Only 5 patients had a complete response, therefore on 5 patients were analyzed for this measure.|||months||Full Range|Median
2833758|NCT00268242|Secondary|White Blood Cell Count at Time of Relapse||After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years.||||cells per microliter||Full Range|Median
2833759|NCT00268242|Secondary|Laboratory Correlates: Immunohistochemistry|"Percentage of patients who had a moderate-strong (2-3+) expression of multidrug resistance (MDR) genes by immunohistochemistry.~Multidrug resistance gene 1 (MDR1)~Equilibrative nucleoside transporter 2(SLC29A2)"|Baseline|23 of 24 patients had available blocks for Immunohistochemical (IHC) analysis; Participants with the SLC29A2 Gene Expression (n=22)|||percentage of participants|||Number
2833760|NCT00268242|Secondary|Disease-free and Overall Survival||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|1 patient died on day 1 of protocol therapy (secondary to complications from AML).|||participants|||Number
2833761|NCT00268242|Primary|Complete Response Rate|Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21%) achieved a CR and therefore, the study was terminated. Since response was assessed using the International Working Group criteria, a complete response was determined by Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL, a cytogenic CR and a morphologic CR with incomplete blood count recovery (CRi).|4 Weeks|A total of 5 patients (21%) achieved a complete response.|||participants|||Number
2833762|NCT00268203|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal.|From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)|ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact.|||Months||95% Confidence Interval|Median
2833763|NCT00268203|Primary|Time to Progression or Death|Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.|From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)|ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
2833764|NCT00268203|Primary|Duration of Response (DOR) in Confirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented CR until PD (up to 161 months)|ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
2833791|NCT00267670|Secondary|Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months|Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.|baseline and one year||||ng/mL||Standard Error|Mean
2837874|NCT00212888|Primary|Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group||Up to week 48||||days||Inter-Quartile Range|Median
2833765|NCT00268203|Primary|Duration of Response (DOR) in Unconfirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented unconfirmed CR until PD (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
2833766|NCT00268203|Primary|Duration of Response for Participants With Confirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
2833767|NCT00268203|Primary|Duration of Response for Participants With Unconfirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.|||Months||95% Confidence Interval|Median
2833768|NCT00268203|Primary|Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed.|||Participants|||Number
2833769|NCT00268203|Primary|Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed.|||Participants|||Number
2833770|NCT00267969|Secondary|Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 52 in participants randomly assigned to a treatment group at Week 40. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 52|Patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||participants|||Number
2833771|NCT00267969|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12|Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline (Week 0), Week 12|Patients were included in the analysis according to the assigned treatment groups. Zero change is imputed if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Scores on a scale||Inter-Quartile Range|Median
2834155|NCT00265330|Primary|Mean Change From Baseline in Supine Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26||||millimeters of mercury (mm Hg)||Standard Deviation|Mean
2833772|NCT00267969|Secondary|Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA is used to determine the participant's psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|Intent to treat. All patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.|||participants|||Number
2833773|NCT00267969|Primary|Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All patients randomized were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.|||Participants|||Number
2833774|NCT00267956|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant's quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The score ranges from 0 (better quality of life) to 30 (worse quality of life).|Week 0 to Week 12|All participants randomized with baseline ≥ 3% body surface area psoriatic involvement were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Scores on scale||Inter-Quartile Range|Median
2833775|NCT00267956|Secondary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12|Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis. This is a test of how bad person's psoriasis is. The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 12|All participants randomized with baseline ≥ 3% body surface area (BSA) psoriatic involvement and with evaluable measurement are included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.|||Participants|||Number
2833776|NCT00267956|Secondary|Change in Health Assessment Questionnaire (HAQ) at Week 12|The HAQ is a 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Week 0 to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.|||Scores on scale||Inter-Quartile Range|Median
2833777|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12|ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participant randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.|||Participants|||Number
2833778|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12|ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.|||Participants|||Number
2833779|NCT00267956|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.|||Participants|||Number
2837875|NCT00212758|Secondary|Change in Height at 56 Weeks||week 1, week 56||||cm||Standard Deviation|Mean
2833780|NCT00267774|Secondary|Cost Effectiveness Measured as Index Procedural and Hospitalization Costs|Costs for each strategy included the initial procedural costs and costs during the 1-year follow-up. The costs of the index procedures were calculated from the actual resource consumption by determining the amount of guiding catheters, regular wires, pressure wires, balloon dilatation catheters, stents, antiplatelet therapy, adenosine, contrast media, and hospital days used for each patient's index procedure. These were multiplied by the cost of each resource in US dollars. All costs were converted to 2008 US dollars using the consumer price index (www.bls.gov).|1 year||||US dollars||Standard Deviation|Mean
2833781|NCT00267774|Primary|Major Adverse Cardiac Events|All cause death, Documented myocardial infarction, Repeat revascularization (PCI and/or CABG) as adjudicated by the Clinical Event Committee|1 year||||participants|||Number
2833782|NCT00267748|Other Pre-specified|FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)|"FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.~The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS."|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Units on scale||Standard Deviation|Mean
2833783|NCT00267748|Other Pre-specified|Functional Assessment of Cancer Therapy-General (FACT-G)|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Units on a scale||Standard Deviation|Mean
2833784|NCT00267748|Secondary|Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Months||95% Confidence Interval|Median
2833785|NCT00267748|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.|||Months||Full Range|Median
2833786|NCT00267748|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.|||Percentage of participants||95% Confidence Interval|Number
2833787|NCT00267748|Primary|Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.|||Months||95% Confidence Interval|Median
2833788|NCT00267696|Secondary|Overall Survival for Patients Treated With the Regimen.|The period of time from study entry until disease progression or date of last contact.|To progression of Disease||||months||95% Confidence Interval|Median
2833789|NCT00267696|Primary|Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.|Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.|up to 6 months||||months||95% Confidence Interval|Median
2833790|NCT00267670|Secondary|Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months||one year||||ug/mL||Standard Error|Mean
2833792|NCT00267670|Secondary|The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH|The mean change from baseline to month 12 in proinflammatory cytokines (such as TNF-α) and gene expresssion were the secondary endpoints and were analyzed with the same analysis of covariance model and summary statistics specified for the primary endpoint. Differences were regarded as statistically significant when P < 0.05. The results for TNF-α are reported here. Interleukin-6 [IL-6], IL-10) and expression of TNF-alpha Receptors (p55 and p75) had insufficient data for statistical analysis.|one year|Intention to Treat with last observation carried forward|||pg/dL||Standard Error|Mean
2833793|NCT00267670|Primary|The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.|The primary goal of the study was to determine whether pentoxifylline (PTX) therapy improved serum ALT (> or = 30% change from baseline to month 12) compared to placebo.|baseline and 12 months|The primary analysis was done as intention to treat. A secondary analysis was performed per protocol and there were no differences between the two analyses. Intention to treat results are reported.|||participants|||Number
2833794|NCT00267644|Secondary|Minimum IVC Diameter|Minimum Inferior Vena Cava Diameter in mm|10 minutes||||mm||Full Range|Median
2833795|NCT00267644|Primary|Maximum IVC Diameter|Maximum Inferior Vena Cava diameter in mm|10 minutes||||mm||Full Range|Median
2833796|NCT00267631|Primary|Diagnosis of Infectious Disease|The Children visiting the ED having an infectious disease|30 minutes||||Participants|||Number
2833797|NCT00267488|Secondary|Safety and Tolerability as Summarized Through Adverse Event Reporting|AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.|Week 0 to week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Number of Events|||Number
2833798|NCT00267488|Secondary|Time to Response|The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98||||Hours||95% Confidence Interval|Mean
2833799|NCT00267488|Secondary|Response Duration|The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98||||Weeks||95% Confidence Interval|Mean
2833800|NCT00267488|Secondary|Overall Survival|Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.|Week 0 to Week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Weeks||95% Confidence Interval|Mean
2833801|NCT00267488|Secondary|Time to Progression|Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.|Week 0 to Week 19 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Weeks||95% Confidence Interval|Mean
2833802|NCT00267488|Primary|Best Overall Response|Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions|Week 0 to Week 98 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.|||Participants|||Number
2833803|NCT00267293|Primary|Child Temperature (Degrees C)Over 6 Hours|Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.|6 hours|Analysis was ITT per sample size calculation at 80% power.|||degrees Celcius||Standard Deviation|Mean
2833804|NCT00267202|Secondary|Number of Participants Requiring 0 to >=5 Doses of Rescue Medications for Systemic Allergic Reactions (SARs) to Specific Immunotherapy (SIT)|Epinephrine for injection, antihistamines, corticosteroids for injection, inhaled beta-agonists, and oral corticosteroids, as well as other drugs used for managing acute allergic reactions to SIT, were available during all study visits. One dose of rescue medication for SAR reactions was equivalent to 1 entry of the CRF page 'concomitant medications/significant non-drug therapies associated with immunotherapy' in response to the question 'Was this medication given in response to a SAR?'|Up to 26 Weeks|Efficacy population: Consisted of all randomized participants who completed the omalizumab or placebo treatment period, received at least one dose of immunotherapy and received rescue therapy.|||participants|||Number
2833805|NCT00267202|Secondary|Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen|During period 3, a cluster dosing protocol was utilized to initiate the allergen immunotherapy (IT). Participants received escalating doses of IT according to a cluster dosing titration regimen. Visits 5 through 13 were cluster visits for this study. The number of visits needed for completion of the cluster SIT dosing regimen was defined as the number of planned visits plus the number of unplanned visits needed to reach maintenance IT dose.|Up to 26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
2833806|NCT00267202|Secondary|Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose|Achievement of target maintenance IT dose is defined as answering 'Yes' to the question, 'Was the target maintenance SIT dose achieved?' on Visit 13, Week 16.|16 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
2833830|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 24 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.|Randomization to 24 Months||||liters per minute per squared meter||Standard Deviation|Mean
2833807|NCT00267202|Secondary|Severity of First Systemic Allergic Reaction (SAR)|Systemic reactions associated with immunotherapy (IT), defined as occurring within 1 hour following injection of SIT, were graded on a four-point scale: Grade 1: Skin symptoms (generalized urticaria, itching, or erythema), Grade 2: Gastrointestinal symptoms (stomach pain, nausea, or vomiting), Grade 3: Respiratory symptoms (clinically significant nasal symptoms and/or dyspnea, wheezing, persistent cough, etc.), Grade 4: Cardiovascular symptoms (cyanosis, hypotension, collapse, arrhythmias, or angina pectoris).|26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
2833808|NCT00267202|Primary|Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)|The number of participants with Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT). A SAR was captured and recorded as an outcome, not as adverse events (AEs) or SAEs. The primary analysis time point was the end of Period 4 (maintenance immunotherapy). Participants were observed for 1 hour after each immunotherapy (IT) injection visit. Allergic reactions were graded on a 4-point scale from Grade 1 to Grade 4. Grade 1: Skin symptoms, Grade 2: Gastrointestinal symptoms, Grade 3: Respiratory symptoms and Grade 4: Cardiovascular symptoms.|26 Weeks|Efficacy Population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.|||participants|||Number
2833809|NCT00267189|Secondary|Number of Patients With Discontinuation of Study Medication||6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.|||Patients|||Number
2833810|NCT00267189|Secondary|Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)|The composite efficacy failure endpoint encompasses at least one of: biopsy proven acute rejection, graft loss, or death for the patient. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy. Acute rejection episodes were recorded as Liver Allograft Rejection. The allograft was presumed to be lost if a patient had a liver retransplant or died.|6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.|||Percentage of patients|||Number
2833811|NCT00267189|Primary|Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)|"The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits.~CrCl[mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|From baseline to 6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication. Patients with baseline and 6 month creatinine clearance were included in analysis. Missing values at 6 months were imputed using the last observation carried forward (LOCF) approach.|||mL/min||Standard Deviation|Mean
2833812|NCT00267150|Secondary|Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy|Assessed by GI complications at baseline.|week 0|Baseline population|||Participants|||Number
2833813|NCT00267150|Primary|Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium|The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.|weeks 6-8||||Change in Score of GSRS||Standard Deviation|Mean
2833814|NCT00267111|Secondary|Visual Analogue Scale|"Parents and nurses were asked to assess the infant's pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0=no pain on the left side and 10=worst possible pain on the right side. Parents and nurses were trained to use the VAS prior to the IM injection."|During the entire procedure|Intention to treat analysis|||Cms||Standard Deviation|Mean
2833815|NCT00267111|Primary|Pain Scores Assessed by Neonatal Facial Action|The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted < 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.|For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.|Intention to treat analysis|||Percentage of time||Standard Deviation|Mean
2833816|NCT00267098|Secondary|Incidence of Ventricular Tachyarrhythmias|Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.|Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.|"Only randomized subjects in the CRT-D device group were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data recorded by CRT-D devices. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-D: Not Randomized, and all CRT-P subgroups were excluded."|||participants|||Number
2833817|NCT00267098|Secondary|CRT-P and CRT-D System Implant Success|The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.|Initial Implant Procedure|"For this outcome measure, only subjects in the No Implant Attempt subgroup were excluded."|||participants|||Number
2833818|NCT00267098|Secondary|Clinical Composite Score at 24 Months|The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 24 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833819|NCT00267098|Secondary|Clinical Composite Score at 18 Months|The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 18 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833820|NCT00267098|Secondary|Clinical Composite Score at 12 Months|The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 12 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833821|NCT00267098|Secondary|Clinical Composite Score at 6 Months|The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 6 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833822|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 24 Months||||ratio||Standard Deviation|Mean
2833823|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 18 Months||||ratio||Standard Deviation|Mean
2833824|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 12 Months||||ratio||Standard Deviation|Mean
2833825|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 6 Months||||ratio||Standard Deviation|Mean
2833826|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.|Randomization to 24 Months||||ms||Standard Deviation|Mean
2833827|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.|Randomization to 18 Months||||ms||Standard Deviation|Mean
2833828|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.|Randomization to 12 Months||||ms||Standard Deviation|Mean
2833829|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.|Randomization to 6 Months||||ms||Standard Deviation|Mean
2833831|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 18 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.|Randomization to 18 Months||||liters per minute per squared meter||Standard Deviation|Mean
2833832|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 12 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.|Randomization to 12 Months||||liters per minute per squared meter||Standard Deviation|Mean
2833833|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 6 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.|Randomization to 6 Months||||liters per minute per squared meter||Standard Deviation|Mean
2833834|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 24 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 24 Months||||percentage of left atrial area||Standard Deviation|Mean
2833835|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 18 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 18 Months||||percentage of left atrial area||Standard Deviation|Mean
2833836|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 12 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 12 Months||||percentage of left atrial area||Standard Deviation|Mean
2833837|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 6 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 6 Months||||percentage of left atrial area||Standard Deviation|Mean
2833838|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 24 Months||||cm||Standard Deviation|Mean
2833839|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 18 Months||||cm||Standard Deviation|Mean
2833840|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 12 Months||||cm||Standard Deviation|Mean
2833841|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 6 Months||||cm||Standard Deviation|Mean
2833842|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 24 Months||||cm||Standard Deviation|Mean
2833843|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 18 Months||||cm||Standard Deviation|Mean
2833844|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 12 Months||||cm||Standard Deviation|Mean
2833845|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 6 Months||||cm||Standard Deviation|Mean
2833859|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.|Randomization to 18 Months||||percentage||Standard Deviation|Mean
2833846|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 24 Months||||grams||Standard Deviation|Mean
2833847|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 18 Months||||grams||Standard Deviation|Mean
2833848|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 12 Months||||grams||Standard Deviation|Mean
2833849|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 6 Months||||grams||Standard Deviation|Mean
2833850|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 24 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833851|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 18 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833852|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 12 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833853|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 6 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833854|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 24 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833855|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 18 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833856|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 12 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833857|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 6 Months||||ml/square meter of body surface area||Standard Deviation|Mean
2833858|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.|Randomization to 24 Months||||percentage||Standard Deviation|Mean
2833860|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.|Randomization to 12 Months||||percentage||Standard Deviation|Mean
2833861|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.|Randomization to 6 Months||||percentage||Standard Deviation|Mean
2833862|NCT00267098|Secondary|Change in Quality of Life at 24 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 24 Months||||units on a scale||Standard Deviation|Mean
2833863|NCT00267098|Secondary|Change in Quality of Life at 18 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 18 Months||||units on a scale||Standard Deviation|Mean
2833864|NCT00267098|Secondary|Change in Quality of Life at 12 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 12 months||||units on a scale||Standard Deviation|Mean
2833865|NCT00267098|Secondary|Change in Quality of Life at 6 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 6 Months||||units on a scale||Standard Deviation|Mean
2833866|NCT00267098|Secondary|Cardiovascular-related Healthcare Utilizations|Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.||||participants|||Number
2833867|NCT00267098|Secondary|Frequency of Adverse Events Post-randomization|Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.||||participants|||Number
2833868|NCT00267098|Secondary|Change in Cardiovascular Medications|The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Because indications for defibrillation devices like CRT-Ds are defined by characteristics that relate to medication guidelines, medication results are presented separately for each device group. Medications were assessed only for subjects who completed visits (denoted as Subjects with Medications Assessed)."|||participants|||Number
2833869|NCT00267098|Secondary|Change in Heart Failure Stage|The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with HF Stage assessed at randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or HF Stage not assessed) are listed under the Comparative data not available category for that time point."|||participants|||Number
2833878|NCT00267059|Primary|Number of Patients in Overall Response Categories|Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.|Evaluated after three 28-day cycles of lenalidomide.|Analysis was intention to treat (ITT): Forty four patients received treatment.|||Participants|||Number
2833870|NCT00267098|Secondary|Change in New York Heart Association Classification|The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with NYHA assessed at both randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or NYHA not assessed at visit) are listed under the Comparative data not available category for that time point."|||participants|||Number
2833871|NCT00267098|Secondary|Days Hospitalized for Heart Failure|For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||Days hospitalized per patient year||Standard Deviation|Mean
2833872|NCT00267098|Secondary|First Heart Failure Hospitalization|The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833873|NCT00267098|Secondary|All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index|"The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization.~Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833874|NCT00267098|Secondary|All-Cause Mortality or Heart Failure-related Hospitalization|The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833875|NCT00267098|Secondary|All-Cause Mortality|"The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared.~This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met)."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833876|NCT00267098|Primary|Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)|Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."|||participants|||Number
2833877|NCT00267085|Primary|Response: One Log Decrease in BCR-ABL|Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.|12 months|All 10 participants on study received treatment and were included in analysis.|||Participants|||Number
2834368|NCT00263588|Secondary|Time to Progression (TTP) at Any Site|Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|Lapatinib Monotherapy MITT|||months||95% Confidence Interval|Median
2833879|NCT00267046|Primary|Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles|Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).|Within the first 2 blinded cycles (3-week cycles), up to 6 weeks.|Intention to treat (ITT).|||Units on a scale||Full Range|Median
2833880|NCT00267046|Primary|Cumulative Incidence Rate of Oral Mucositis|"Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles.~WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible."|Within 6 blinded cycles (3-week cycles), up to 18 weeks.|Intention to treat (ITT).|||Percentage of Participants||95% Confidence Interval|Mean
2833881|NCT00267007|Secondary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|baseline to Day 128|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.|||participants|||Number
2833882|NCT00267007|Primary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|Baseline to Week 12|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.|||participants|||Number
2833883|NCT00266877|Secondary|Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer|Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death, assessed up to three years.||||weeks||90% Confidence Interval|Median
2833884|NCT00266877|Secondary|Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first PD, assessed up to three years after the first randomization.|Number of subjects with PR or higher response.|||weeks||90% Confidence Interval|Median
2833885|NCT00266877|Secondary|Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer|Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From first dose date to progression/death or last tumor assessment, up to three years.||||percentage of participants||90% Confidence Interval|Number
2833886|NCT00266877|Primary|Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer|Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression/death or last tumor assessment, up to three years.|modified ITT: Subjects who were randomized and who had taken at least 1 dose of neratinib; equivalent to the safety population|||percentage of participants||90% Confidence Interval|Number
2833887|NCT00266864|Secondary|Resting Energy Expenditure|Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise.|12 months||||kcal/day||Standard Deviation|Mean
2833888|NCT00266864|Primary|Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)|"Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the on-and-off -the-table method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM."|12 months||||kilograms||Standard Deviation|Mean
2833889|NCT00266851|Secondary|Asthma Exacerbations|A steroid burst, an unscheduled or emergency visit and/or a hospitalization for asthma, reported at Weeks 0, 6, 12, 18, 24, 30, 36, 42, 48, and any time during follow up.|up to 12 months|This study was not powered to detect significant differences in exacerbation frequency.|||Participants|||Count of Participants
2834391|NCT00263328|Secondary|Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit||Months 12 and 24|Safety population|||cells/uL||Standard Deviation|Mean
2833890|NCT00266851|Secondary|Change is Asthma-specific Quality-of-Life (AQL)|Juniper Asthma Quality of Life Questionnaire is a 32-item survey, recall of the past 2 weeks, scored on a 7 point Likert scale where 1 is severely impaired, and 7 is not impaired at all. Scores are averaged for a final range of 1-7. Change from Baseline is reported here.|Within the past 2 weeks; every three months|All participants did not adhere to follow-up schedule|||score on a scale||Standard Deviation|Mean
2833891|NCT00266851|Secondary|Change in Asthma Control Over Baseline|Mini-Juniper Asthma Control Questionnaire without pulmonary function. This is a 6-item survey scored on a 7 point scale where 0 is none, or no symptoms and 6 is severe or symptoms all of the time. Answers are averaged for a final score of 0-6. Data are reported as a change from baseline.|Within the past week; every 3 months|All participants did not adhere to follow-up schedule|||scores on a scale||Standard Deviation|Mean
2833892|NCT00266851|Primary|Change in Overall Asthma Symptoms From Baseline|5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms|Within the past 24 hours; measured every 1.5 months for one year|All participants did not adhere to follow-up schedule|||units on a scale||Standard Deviation|Mean
2833893|NCT00266825|Secondary|Preterm Births|Percentage of births occurring at less than 37 weeks of gestation.|births before week 37 of gestation||||percentage of births|||Number
2833894|NCT00266825|Secondary|Head Circumference|Measure of circumference of baby's head in centimeters at time of birth.|at time of birth||||centimeters||Standard Deviation|Mean
2833895|NCT00266825|Secondary|Cord RBC-phospholipid-DHA|Percentage of total fatty acids by weight in cord RBC|at time of birth||||percentage of cord RBC||Standard Deviation|Mean
2833896|NCT00266825|Secondary|Gender of Babies||at time of birth||||percentage of babies|||Number
2833897|NCT00266825|Primary|Birth Length|Length of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||centimeters||Standard Deviation|Mean
2833898|NCT00266825|Primary|Birth Weight|Weight of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||grams||Standard Deviation|Mean
2833899|NCT00266825|Primary|Gestational Age|Gestational age of babies at time of birth in days|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||days||Standard Deviation|Mean
2833900|NCT00266825|Secondary|Ponderal Index|Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.|at time of birth||||units on a scale||Standard Deviation|Mean
2833901|NCT00266825|Primary|Percentage of Total Fatty Acids by Weight|Measure of RBC-phospholipid-DHA at Birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.|||percentage of fatty acid||Standard Deviation|Mean
2833902|NCT00266812|Primary|Number of Participants With Progression-free Survival (6 Month)|The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as <25% increase in tumor size on CT or MRI.|6 months|Intent to treat (ITT) population (31 of the 35 patients enrolled; 4 participants discontinued prior to start of treatment) was analyzed.|||Participants|||Number
2833903|NCT00266799|Secondary|Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))|QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.|From Screening to Day 1 of every Treatment Cycle up to 12 Cycles|ITT: included all randomized participants. There were only a few participants who completed more than 12 cycles due to the longer duration of each cycle.|||Percentage of Participants|||Number
2833904|NCT00266799|Secondary|Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups|Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.|From Day 1 (Cycle 1) until End of Treatment|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.|||Months||95% Confidence Interval|Median
2833905|NCT00266799|Secondary|Overall Survival Time in the PLD and Capecitabine Treatment Groups|Survival time was defined as duration time from onset of treatment with the study drug until death.|From Day 1 (Cycle 1) until Death|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.|||Months||95% Confidence Interval|Median
2833916|NCT00266708|Secondary|Bone Histomorphometry - Mineralized Bone Volume (MdV)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Bone mineralization is the process of laying down minerals on the matrix of the bone, with calcium and phosphorus as the most abundant minerals. Mineralized Bone Volume (MdV) is the percentage of mineralized bone tissue.|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833906|NCT00266799|Secondary|Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups|Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT) population included all randomized participants.|||Participants|||Number
2833907|NCT00266799|Primary|Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT): 7 in PLD group & 3 participants in Capecitabine group were missing response assessments. TTP Population: included participants in view of major protocol violations/deviations, i.e. tumor-relevant inclusion/exclusion criteria, treatment compliance, tumor assessments by RECIST with maximum 4 month interval between assessments.|||Months||95% Confidence Interval|Median
2833908|NCT00266708|Secondary|Bone Histomorphometry - Osteoid Volume (OV)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the Osteoid Volume (OV), the volume of bone that consists of unmineralized bone.|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||micron^3||Standard Deviation|Mean
2833909|NCT00266708|Secondary|Bone Histomorphometry - Bone Formation Rate|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone formation rate (BFR) indicates how much of the bone is actively mineralizing; it is determined by the number of active OB and the average work of each OB.|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||micron/day||Standard Deviation|Mean
2833910|NCT00266708|Secondary|Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secret digestive enzymes tha break up or dissolve the bone tissue. An eroded surface (ES) is the surface of the lacuna ( a cavity or depression in the bone) generated by an active OC. The reported values indicate the percent of eroded surface relative to bone surface (BS).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833911|NCT00266708|Secondary|Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secrete digestive enzymes that break up or dissolve the bone tissue. Bone mass is a balance between the osteoblasts (OB) cells that form the bone and the osteoclasts (OC) cells that break down the bone. The reported values indicate the percent of bone surface (BS) that consists of osteoclasts (OC).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833912|NCT00266708|Secondary|Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone mass is a balance between the osteoblasts (OB) that form the bone and cells called osteoclasts (OC) that break down the bone. The reported values indicate the percent of bone surface (BS) that is made up of osteoblasts (OB).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833913|NCT00266708|Secondary|Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of bone surface that consists of unmineralized bone. It is equal to Osteoid Surface (OS) divided by Bone Surface (BS).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833914|NCT00266708|Secondary|Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of tissue (bone + marrow) that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Tissue Volume (TV).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833915|NCT00266708|Secondary|Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of bone that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Bone Volume (BV).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2842384|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42||||L||Standard Error|Mean
2833917|NCT00266708|Secondary|Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Mineralized Bone Volume is the percentage of Bone Volume consisting of mineralized bone. Percent Mineralized Bone Volume is calculated as Mineralized Bone Volume (MdV) divided by Bone Volume (BV).|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833918|NCT00266708|Secondary|Bone Histomorphometry - Trabecular Thickness (TbTh)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. The ends of certain bones, known as cancellous bones, are actually not solid but are full of holes that are connected to each other by thin rods and plates of bone tissue known as trabeculae. Trabeculae of bone provide structural support to the spongy bone found at the ends of long bones. Trabeculae Trabecular Thickness (TbTh), a structural parameter, is the distance across individual trabecula.|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||micron||Standard Deviation|Mean
2833919|NCT00266708|Secondary|Bone Histomorphometry - Percent Bone Volume (BV/TV)|Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Bone Volume is the percentage of total volume occupied by calcified bone. Percent Bone volume is calculated as Bone Volume (BV) divided by Tissue Volume (TV), where TV is bone plus marrow.|Baseline and month 12 of the treatment|Calculation done on intent-to-treat population|||percent||Standard Deviation|Mean
2833920|NCT00266708|Primary|Bone Mineral Density of Forearm at 12 Months|Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.|month 12 of the treatment|Calculation done on intent-to-treat population|||gm/cm^2||Standard Deviation|Mean
2833921|NCT00266708|Primary|Bone Mineral Density of Forearm at 6 Months|Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.|month 6 of the treatment|Calculation done on intent-to-treat population|||gm/cm^2||Standard Deviation|Mean
2833922|NCT00266708|Primary|Bone Mineral Density of the Hip at 12 Months|Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.|month 12 of the treatment|Calculation done on intent-to-treat population|||gm/cm^2||Standard Deviation|Mean
2833923|NCT00266708|Primary|Bone Mineral Density of the Hip at 6 Months|Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.|month 6 of the treatment|Calculation done on intent-to-treat population|||gm/cm^2||Standard Deviation|Mean
2833924|NCT00266708|Primary|Bone Mineral Density of Spine at 12 Months|Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.|month 12 of treatment|Calculation done on intent-to-treat population|||gm/cm^2||Standard Deviation|Mean
2833925|NCT00266708|Primary|Bone Mineral Density of Spine at 6 Months|Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.|month 6 of the treatment|Calculation done on intent-to-treat population|||gm/cm^2||Standard Deviation|Mean
2833926|NCT00266695|Secondary|Number of Participants Receiving Treatment With Panretinal Photocoagulation||Baseline up to Month 24|All enrolled participants.|||participants|||Number
2833927|NCT00266695|Secondary|Number of Participants Receiving Treatment With Focal/Grid Photocoagulation||Baseline up to Month 24|All enrolled participants.|||participants|||Number
2833928|NCT00266695|Secondary|Visual Acuity|Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA.|Month 24|All enrolled participants. Last observation carried forward (LOCF).|||letters read correctly||Standard Deviation|Mean
2833929|NCT00266695|Secondary|Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval|An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed.|Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months|All enrolled participants (pts) at risk during the specified intervals. Pts who did not experience an event during the interval were censored to the last time point in the interval. Number of pts censored: 0 to 6 months = 2 pts, 6 to 12 months = 4 pts, 12 to 18 months = 9 pts, 18 to 24 months = 82 pts, and 24 to 30 months = 90 pts.|||participants|||Number
2833938|NCT00266656|Secondary|Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years|Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.|||years||Standard Error|Mean
2833939|NCT00266656|Secondary|Age at Attainment of Tanner 2 Breast Development|The Tanner 2 breast development is the age at first evidence of breast development.|Baseline through End of Study (10 years)|All participants who had a baseline visit and at least one post-baseline visit.|||years||Standard Error|Mean
2833930|NCT00266695|Secondary|Sustained Moderate Vision Loss (SMVL), Long Term|The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term)|Participants who were treated with 32 milligram (mg) ruboxistaurin once daily in Study MBCM and had at least 1 DR study eye, who were also enrolled in Study MBDV.|||participants|||Number
2833931|NCT00266695|Secondary|Vision Loss|The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months|All enrolled participants.|||participants|||Number
2833932|NCT00266695|Primary|Sustained Moderate Visual Loss (SMVL)|The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline, 18 months up to 24 months|All enrolled participants.|||participants|||Number
2833933|NCT00266656|Secondary|Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
2833934|NCT00266656|Secondary|Percentage of Participants With Prevalence of Abnormal Audiometry Results|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
2833935|NCT00266656|Secondary|Percentage of Participants With Abnormal Tympanometry Results|Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
2833936|NCT00266656|Secondary|Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events|Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||percentage of participants|||Number
2833937|NCT00266656|Secondary|Reports of Serious Adverse Events|"Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.|||events|||Number
2833977|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833940|NCT00266656|Secondary|Height SDS at Various Ages|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Age 10, Age 13, Age 16|All participants who had a baseline visit and at least one post-baseline visit.|||Standard deviation score||Standard Deviation|Mean
2833941|NCT00266656|Primary|Most Mature Height Standard Deviation Score (SDS)|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.|||standard deviation score||Standard Deviation|Mean
2833942|NCT00266630|Secondary|Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values|High density lipoprotein: males low 40 milligram/deciliter (mg/dL), high 80 mg/dL; females low 40 mg/dL, high 90 mg/dL. Low density lipoprotein (LDL): males and females low 70 mg/dL, high 139 mg/dL. Hemoglobin A1C (HBA1C): males and females low 4.3%, high 5.8%.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
2833943|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)|High QTcF: more than or equal to 450 milliseconds (msec) for males; more than or equal to 470 milliseconds (msec) for females|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements and no abnormal values in the direction at baseline (e.g. participants with an abnormally low value for a given parameter at baseline who showed an abnormally low value for the same parameter at a later visit were not included). Last observation carried forward.|||participants|||Number
2833944|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight|Low systolic blood pressure (SBP): <=90 millimeter mercury (mmHg) and decrease of >=20 mmHg; High SBP: >=180 mmHg and increase of >=20 mmHg; Low diastolic blood pressure (DBP): <=50 mmHg and decrease of >=15 mmHg; High DBP: >=105 mmHg and increase of >=15 mmHg; Low pulse: <50 beats per minute (bpm) and decrease of >=15 bpm; High pulse: >120 bpm and an increase of >=15 bpm; Low weight: decrease of >=7%; High weight: increase of >=7%;|baseline through 18 weeks|Analyzed were all study participants.|||participants|||Number
2833945|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes|Triglycerides: high limit equal to or more than 500 milligram/deciliter (mg/dL); Glucose (non-fasting): low limit 2.4975 mmol/liter (L); high limit 13.875 mmol/L; Glucose (fasting): low limit 2.4975 mmol/L; high limit 6.993 mmol/L.|baseline through 18 weeks|Analyzed were all participants without an abnormal value in the direction at baseline (for example, participants with an abnormally low value at baseline who experienced an abnormally low value at any time post baseline were not included, but were included if they experienced an abnormally high value at any time post baseline).|||participants|||Number
2833946|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dyskenisia was defined as a score of equal or more than 2 or an increase of equal to or more than 2 points from baseline on the dyskenisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
2833947|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dystonia was defined as a score equal or more than 2 or an increase of equal or more than 2 points from baseline on the dystonia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
2833948|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent akathisia was defined as a score of equal or more than 2 or an increase of equal or more than 2 points from baseline on the akathisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
2833949|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). Parkinsonism is assessed by the total points of items 1 to 5 (total score of 0 to 20). Treatment-emergent parkinsonism was defined as a score of equal or greater than 3 on 1 item, equal or greater than 2 on 2 items, or an increase of equal or greater than 3 from baseline on the parkinsonism total.|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.|||participants|||Number
2834445|NCT00262951|Secondary|Overall Survival|In all patients, measured from the date of the patient's registration in this study, until the date of the patient's death or date last known alive (if observation was censored).|Up to 5 Years or Date of Death, Whichever Occurred First||||Months||95% Confidence Interval|Median
2833950|NCT00266630|Secondary|Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by the total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by the points given to the corresponding items.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2833951|NCT00266630|Secondary|Number of Participants Who Switched to Syndromic Depression|As defined as a shift from a Manic Episode at baseline to a Major Depressive Episode, at any post baseline visit, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.|baseline through 18 weeks|Analyzed were all participants who had a manic episode at baseline.|||participants|||Number
2833952|NCT00266630|Secondary|Positive and Negative Syndrome Scale Positive Scores - Visit Data|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For the analysis, the score was converted to 0 to 6 for each item range; hence, the total score ranges from 0 to 42.|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2833953|NCT00266630|Secondary|Number of Participants Who Experienced Remission of Bipolar Disorder|Participants who had equal to or less than 12 points in YMRS total score and equal to or less than 7 points in HAMD-17 total score at 18 weeks. YMRS: 11-item scale, measures the severity of manic episodes. 4 items are rated from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total: 0 to 60. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale or a 5-point scale. HAMD-17 total score: 0 (normal) to 52 (severe).|Week 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
2833954|NCT00266630|Secondary|Number of Participants With Relapse of Depressive Symptoms|Assessed were participants meeting remission criteria for bipolar disorder in Study BMAC and have a HAMD-17 total score greater than or equal to 13 at any time. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who had 12 points or less in the YMRS total score and 7 points or less in the HAMD-17 total score at baseline.|||participants|||Number
2833955|NCT00266630|Secondary|Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)|Incidence of depressive symptoms was defined as a score of equal to or more than 13 points on the HAMD-17. The 17-item HAMD measures depression severity. Each item was evaluated and scored a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants who had equal to or less than 7 points on the HAMD-17 total score at baseline.|||participants|||Number
2833956|NCT00266630|Secondary|Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data|Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2833957|NCT00266630|Secondary|Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2833958|NCT00266630|Primary|Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only|Patients achieved remission in Study BMAC (defined as YMRS total score <=12 and HAMD-17 total score <=7) and obtained YMRS total score of >=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who were in remission at baseline (end of Study BMAC) with 12 points or less in YMRS total score and 7 points or less in the 17-item Hamilton Depression Rating Scale total score.|||participants|||Number
2833959|NCT00266630|Primary|Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only|Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
2833978|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833960|NCT00266630|Primary|Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only|Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.|||participants|||Number
2833961|NCT00266630|Primary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|The primary objective was only interested in the effects in the olanzapine monotherapy arm, thus the results for the olanzapine + mood stabilizer arm are presented as secondary outcomes. Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2833962|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Per Protocol Population (subjects of ITT population who have no major protocol violations)|||cumulative percent of responders|||Number
2833963|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period|Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
2833964|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks||8 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833965|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks||7 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833966|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks||6 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833967|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks||5 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833968|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks||4 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833969|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks||3 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833970|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks||2 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2833971|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week||1 week|ITT population, but only patients with non-missing assessments were included|||participants|||Number
2833972|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
2833973|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833974|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833975|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833976|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834762|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||ng/mL||Full Range|Median
2833979|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833980|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833981|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
2833982|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833983|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833984|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833985|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833986|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833987|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833988|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833989|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833990|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
2833991|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833992|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833993|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833994|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833995|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833996|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833997|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833998|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2833999|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
2834000|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|8 weeks|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
2834001|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|7 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834002|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|6 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834003|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|5 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834004|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|4 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834005|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|3 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834006|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.|2 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834007|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|1 week|ITT population, but only patients with non-missing values are included in the analysis|||participants|||Number
2834008|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834765|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834009|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834010|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included|||participants|||Number
2834011|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 2 weeks|ITT population, but only patients with non-missing values were included|||Participants|||Number
2834012|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||participants|||Number
2834013|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|8 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834014|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|7 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834015|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|6 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834016|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|5 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834017|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|4 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834018|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|3 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834019|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|2 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834020|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|1 week|ITT population, but only patients with a non-missing value at timepoint are included in the analysis|||participants|||Number
2834021|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied|||Units on a scale||Standard Deviation|Mean
2834022|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 8 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834023|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 7 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834059|NCT00266032|Secondary|Number of Bleeding / Spotting Episodes in 90 Day Reference Period|The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation|||Episodes||Standard Deviation|Mean
2834024|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 6 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834025|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 5 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834026|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 4 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834027|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 3 weeks|ITT population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834028|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 2 Weeks|ITT Population, only subjects with non-missing values have been included|||Units on a scale||Standard Deviation|Mean
2834029|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 1 week|ITT population, but only subjects with values at baseline and time point are included in the analysis|||Units on a scale||Standard Deviation|Mean
2834030|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Intent-to-treat population|||cumulative percent of responders|||Number
2834031|NCT00266279|Secondary|Qualitative and Quantitative Toxicity|The most common toxicities were grades 1 or 2 fatigue and anemia .|Every two 28 day treatment cycles||2018-12-31|12/2018||||
2834032|NCT00266279|Primary|Overall Response Rate|"Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.~Overall Response Rate (ORR)=PR+CR."|Every two 28 day treatment cycles until subject no longer on treatment due to disease progression||||Participants|||Number
2834033|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48|The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
2834034|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48|DAS28-ESR remission was defined as a DAS28-ESR < 2.6|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
2834035|NCT00266227|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all randomized participants, with data available for analyses.|||Score on a scale||Full Range|Median
2834036|NCT00266227|Secondary|Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2834060|NCT00266032|Secondary|Number of Bleeding / Spotting Days by 90-day Reference Period|The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.|up to 1 year|FAS (reflecting ITT), all treated subjects, no imputation|||Days||Standard Deviation|Mean
2842385|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42||||L||Standard Error|Mean
2834037|NCT00266227|Secondary|ACRn in Retreated Subjects at Week 48|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). A positive ACRn Score indicates an improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2834038|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.3 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
2834039|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.22 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Percentage of participants|||Number
2834040|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48|Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||millimeter/hour (mm/hr)||Standard Deviation|Mean
2834041|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48|Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat Population includes all participants randomized to Retreatment.|||mg/dL||Standard Deviation|Mean
2834042|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Assessment of Pain at Week 48|Patients rated their pain at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (none) to 100 (unbearable pain). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment with data available for analyses.|||millimeter (mm)||Standard Deviation|Mean
2834043|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48|A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||millimeter (mm)||Standard Deviation|Mean
2834044|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Global Assessment of Disease Activity at Week 48|Participants rated their disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||millimeter (mm)||Standard Deviation|Mean
2834045|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Score on a scale||Standard Deviation|Mean
2834046|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Tender Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 68 joints at baseline and at Week 48. A negative change from baseline in the Tender Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Joint Count||Standard Deviation|Mean
2834047|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Swollen Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 66 joints at baseline and at Week 48. A negative change from baseline in Swollen Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Joint Count||Standard Deviation|Mean
2834061|NCT00266032|Secondary|Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days|For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.|up to 1 year|FAS (reflecting ITT population), all treated subjects, no imputation|||Days||Standard Deviation|Mean
2842386|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36||||L||Standard Error|Mean
2834048|NCT00266227|Secondary|Percentage of Retreated Subjects With a European League Against Rheumatism (EULAR) Response at Week 48|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Percentage of participants|||Number
2834049|NCT00266227|Secondary|Change From Baseline in Disease Activity Score (DAS28-CRP) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population that includes all participants randomized to Retreatment with data available for analyses.|||Units on a scale||Standard Deviation|Mean
2834050|NCT00266227|Secondary|Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|48 weeks|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.|||Units on a scale||Standard Deviation|Mean
2834051|NCT00266227|Secondary|Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline|ACR50 or ACR70 response was defined as a ≥ 50% or 70% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 50% or 70% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.|||Participants|||Number
2834052|NCT00266227|Primary|Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline|ACR20 response was defined as a ≥ 20% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 20% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|48 Weeks|Intent-to-treat population includes all participants randomized to Retreatment.|||Participants|||Number
2834053|NCT00266110|Secondary|Generation of Interferon Gamma Positive CD8+T Cells|Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for interferon gamma positive CD8+ T cells|13 weeks|Three subjects had insufficient samples due to early withdraw from study, and one subject was removed from study before the vaccine was administered.|||percentage of cells||Full Range|Mean
2834054|NCT00266110|Secondary|Generation of E75/E90 Tetramer-positive CD8+ T Cells|Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for E75/E90 tetramer-positive CD8+ T cells|13 weeks|One patient failed to have blood drawn for correlative studies following second vaccine.|||Percentage||Full Range|Mean
2834055|NCT00266110|Primary|Number of Participants With Response|Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|5-6 years||||Participants|||Count of Participants
2834056|NCT00266032|Post-Hoc|Pearl Index (FDA Criteria)|Following an FDA request another PI evaluation was done for the first year of treatment only and taking into consideration also pregnancies with a conception date within 14 days after end of the study medication. Restricting the analysis to the required first year of treatment, it results in this PI estimation.|Up to one year|FAS|||Pregnancies per 100 woman years||95% Confidence Interval|Mean
2834057|NCT00266032|Post-Hoc|Number of Unintended Pregnancies Including Pregnancies Occuring Within 14 Days After End of Study Medication.|Pregnancies with conception date during treatment and within 14 days after end of study medication were included.|Up to one year|FAS|||Pregnancies|||Number
2834058|NCT00266032|Secondary|Days With Scheduled Versus Unscheduled Bleeding|Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation|||Days||Standard Deviation|Mean
2842387|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36||||L||Standard Error|Mean
2834063|NCT00266032|Primary|Adjusted Pearl Index|The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||Pregnancies per 100 woman years||95% Confidence Interval|Mean
2834064|NCT00266032|Primary|Number of Unintended Pregnancies Due to Method Failure|Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||Pregnancies|||Number
2834065|NCT00266032|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||Pregnancies per 100 woman years||95% Confidence Interval|Mean
2834066|NCT00266032|Primary|Number of Unintended Pregnancies in Yaz Flexible Arm|Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.|up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year|||pregnancies|||Number
2834067|NCT00266032|Primary|Number of Days With Bleeding Including Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.|up to 1 year|Full Analysis Set (FAS) (reflecting Intention To Treat (ITT) population), all treated subjects with data available, no imputation|||days||Standard Deviation|Mean
2834068|NCT00265980|Secondary|TEE/FFM|To measure the total energy expenditure/fat-free mass (FFM) (in kcal/kg).|Baseline, 11 weeks, 18 weeks||||kcal/kg||Standard Deviation|Mean
2834069|NCT00265980|Primary|Total Energy Expenditure (TEE)|To measure the metabolic changes associated with maintenance of a reduced body weight (in kcal/day)|Baseline, 11 weeks, 18 weeks||||kcal/day||Standard Deviation|Mean
2834070|NCT00265941|Secondary|2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response|Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy.|From randomization to 2 years|Randomized eligible N2-3 patients with follow-up and PET data|||percentage of participants||95% Confidence Interval|Number
2834071|NCT00265941|Secondary|Correlation of Pre-treatment Positron Emission Tomography (PET)/CT Maximum Standardized Uptake Value (SUVmax) With PFS, OS, and LRF|SUVmax is categorized as high (>median) and low (</=median). All times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional failure (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible N2-3 patients with follow-up and PET data|||percentage of participants||95% Confidence Interval|Number
2834072|NCT00265941|Secondary|Correlation of Expression of Epidermal Growth Factor Receptor (EGFR) With PFS, OS, and LRF|EGFR expression is categorized as high (>/=80%) and low (<80%) in order to compare outcome by favorable and unfavorable risk group, per protocol. Times are measured from randomization. Overall survival is defined as time from randomization to date of death from any cause. PFS is time to loco-regional progression (LRP), distant disease progression (DDP), or death. LRF is time to LRP, DDP, or death, with DDP considered a competing risk. Patients last known to be alive without event are censored at the date of last contact. LRP is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. DDP is defined as clear evidence of distant metastases. Three-year LRF rates were estimated by the cumulative incidence method. Three-year PFS and OS rates were estimated by the Kaplan-Meier method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up and EGFR data.|||percentage of participants||95% Confidence Interval|Number
2834073|NCT00265941|Secondary|Quality of Life as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-HN) at 12 Months|The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) is a 10-item self-report instrument designed to measure multidimensional quality of life in patients with head and neck cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-40. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-HN including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Change from baseline to 12 months (12 months - baseline) is reported.|Baseline and 12 months|Randomized eligible patients with baseline and 12-month FACT-HN data.|||units on a scale||Standard Deviation|Mean
2842388|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30||||L||Standard Error|Mean
2834074|NCT00265941|Secondary|Quality of Life as Measured by Proportion of Patients With Performance Status Scale for Head and Neck Cancer (PSS-HN) Scores ≤ 50|The PSS-HN is a clinician rated instrument consisting of assessment of three functions (subscales): Normalcy of Diet, Eating in Public, and Understandability of Speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores on each subscale range from 0-100, with higher scores indicating better performance. It has been demonstrated to be reliable and valid in head and neck cancer patients.The site research nurse or clinical research associate (CRA) will determine the score on each of the subscales by performing a clinical evaluation and unstructured interview format. The PSS-HN takes approximately 5 minutes to complete.|3 months and 12 months|Randomized eligible patients with PSS-HN data at the given time point.|||proportion of participants||95% Confidence Interval|Number
2834075|NCT00265941|Secondary|Quality of Life as Measured by European Quality of Life Questionnaire (EQ-5D)|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state).|3 months and 12 months|Randomized eligible patients with EQ-5D data at the given time point.|||units on a scale||Standard Deviation|Mean
2834076|NCT00265941|Secondary|Rate of Deaths ≤ 30 Days After Discontinuation of Protocol Treatment|Patients who died during treatment or within 30 days after the end of treatment|From start of treatment to 30 days after the end of treatment|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834077|NCT00265941|Secondary|Rate of Patients Who Tolerated Treatment|A patient was considered to have tolerated treatment if radiation therapy was scored as per protocol or with acceptable variation, they received 2 cycles of cisplatin, and for arm 2, they received the initial dose of cetuximab and at least 5 weekly doses of cetuximab .|From start of treatment to end of treatment (6-7 weeks)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834078|NCT00265941|Secondary|Rate of Other Toxicity ≥ Grade 3 (Not Mucositis)|Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 other than radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834079|NCT00265941|Secondary|Rate of Mucositis Toxicity ≥ Grade 3|Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834080|NCT00265941|Secondary|Local-regional Failure (LRF) (3-year Rate Reported)|Local-regional failure is defined as time from randomization to date of failure (local or regional progression), or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Distant disease progression is considered a competing risk. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases. Three-year rates were estimated by the cumulative incidence method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834081|NCT00265941|Secondary|Overall Survival (OS) (3-year Rate Reported)|Overall survival is defined as time from randomization to date of death from any cause. Patients last known to be alive are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834082|NCT00265941|Primary|Progression-free Survival (PFS) (3-year Rate Reported)|Progression-free survival (PFS) is defined as time from randomization to date of local, regional, or distant disease progression, or death from any cause. Patients last known to be alive without progression are censored at the date of last contact. Three-year rates were estimated by the Kaplan-Meier method. Local or regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as clear evidence of distant metastases.|From randomization until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)|Randomized eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2834083|NCT00265889|Primary|Number of Patients That Experience Pulmonary Toxicity|Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.|One year after second transplant|Analysis is per protocol, so includes patients who received treatment|||participants|||Number
2834084|NCT00265889|Primary|Response Rate|Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|One year after second transplant|Analysis is per protocol, so includes patients who received both transplants|||participants|||Number
2834085|NCT00265889|Primary|Progression-free Survival|Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|one year after second transplant|Analysis is per protocol, so includes patients who received both transplants|||participants|||Number
2834086|NCT00265850|Secondary|Duration of Tumor Response||Up to 5 years post-treatment|||||||
2834087|NCT00265850|Secondary|Time to Treatment Failure||Up to 5 years post-treatment|||||||
2834088|NCT00265850|Secondary|Progression-free Survival (PFS)|PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.|Up to 5 years post-treatment|All eligible KRAS wild type patients were included in this analysis.|||months||95% Confidence Interval|Median
2834089|NCT00265850|Primary|Overall Survival|Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.|Up to 5 years post-treatment|All eligible KRAS wild type patients that began treatment were included in this endpoint.|||months||95% Confidence Interval|Median
2834090|NCT00265798|Secondary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause.|Up to 5 years||||months||95% Confidence Interval|Median
2834091|NCT00265798|Secondary|Progression-free Survival|"Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first.~CT scans for disease reassessment will be obtained pre-therapy and every 8 weeks."|Up to 5 years||||months||95% Confidence Interval|Median
2834092|NCT00265798|Primary|Objective Response Rate|"Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response."|Up to 5 years||||percentage of partcipants||95% Confidence Interval|Number
2834093|NCT00265785|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2834094|NCT00265785|Secondary|Response (Confirmed and Unconfirmed, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.|Eligible and analyzable patients with measurable disease at baseline are included in this measure.|||percentage of participants||95% Confidence Interval|Number
2834095|NCT00265785|Primary|Overall Survival|Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.|||months||95% Confidence Interval|Median
2834096|NCT00265785|Secondary|Progression-free Survival|Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.|||months||95% Confidence Interval|Median
2834097|NCT00265759|Secondary|Overall Survival (Cohort A and B)|Overall survival (OS) will be measured from the date of randomization until the date of death. The distribution of overall survival times will be estimated using the Kaplan-Meier method.|assessed up to 10 years||2022-08-31|08/2022||||
2834098|NCT00265759|Secondary|Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)|Rate (percentage) of Improved surgical outcome for patients designated as candidates for mastectomy prior to therapy (Cohort A). Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients considered candidates for mastectomy prior to therapy.|||percentage of patients||95% Confidence Interval|Number
2834099|NCT00265759|Secondary|Clinical Response Rate (Cohort B)|The clinical response rate is defined as 100 times the number of eligible patients whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients. A 90% binomial confidence interval will be constructed for the true clinical response rate.|Up to 18 weeks|Outcome Measure Data Not Collected.||||||
2834100|NCT00265759|Secondary|The Pathologic Complete Response (pCR) Rate (Cohort A)|The pathologic complete response is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes. The pathologic complete response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgical specimen is such that there is no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the pCR between these 2 treatments.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients who had surgery performed after completion of AI therapy.|||percentage of patients||95% Confidence Interval|Number
2834101|NCT00265759|Secondary|Rate of Lymph Node Involvement (LNI) (Cohort A)|For those patients who undergo a sentinel lymph node dissection or an axillary lymph node dissection (at least 6 nodes examined with Hematoxylin & Eosin Staining), the LNI rate (percentage) is defined as 100 times the proportion of eligible patients randomized to that treatment with at least one positive node. For each neo-adjuvant endocrine treatment, a 95% binomial confidence interval will be constructed for its true LNI rate.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed include only patients who were evaluated for the number of positive nodes and not evaluated before or during AI therapy.|||percentage of patients||95% Confidence Interval|Number
2834102|NCT00265759|Secondary|Rate of Downstaging to Stage I Determined by Sentinel Node Evaluation (Cohort A)|The rate downstaging to Stage I of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgically findings are such that the maximum dimension of the invasive lesion contained in their surgical specimen is at most 2 cm and their lymph nodes are negative (by Hematoxylin & Eosin Staining) divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the rate of downstaging to Stage I between these 2 treatments.|At time of surgery up to 18 weeks|Outcome Measure Data Not Collected.||||||
2834103|NCT00265759|Secondary|Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)|The rate (percentage) of improved surgical outcome for patients considered marginal for breast conservation surgery prior to therapy for Cohort A is reported below for each treatment arm. Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.|At time of surgery up to 18 weeks|Overall Number of Participants Analyzed only includes patients considered marginal for breast conservation surgery prior to therapy.|||percentage of improved surgical outcome||95% Confidence Interval|Number
2834104|NCT00265759|Secondary|Progression-free Survival (PFS) (Cohort A and B)||assessed up to 10 years||2022-08-31|08/2022||||
2834105|NCT00265759|Secondary|Toxicity (Cohort A)|Incidence of the most common grade 3+ toxicities reported to be probably, possibly, or definitely related to treatment as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (Cohort A) At each treatment evaluation, the type, severity, and attribution of each adverse event reported will be assessed using the NCI-CTCAE definitions. For each treatment, the percentage of patients who developed a severe (grade 3+) toxicity considered possibly, probably or definitively related to treatment will be determined.|Up to 30 days after drug therapy||||percentage of patients|||Number
2834106|NCT00265759|Primary|Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)|The primary aim is to assess the anti-tumor effect in terms of pathologic CR rates of neo-adjuvant chemotherapy in patients with T2-T4c, any N, M0 breast cancer (by clinical staging) who are endocrine therapy resistant (that is, their Ki-67 level is >10 after 2-4 week of neo-adjuvant endocrine therapy alone). The pCR rate (percentage) for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.|Up to 18 weeks|The Overall Number of Participants Analyzed is a subset of the number of patients in Cohort B Arm II: Week 2 Ki67 >10% who switched to neoadjuvant chemotherapy. The remaining number of patients in this arm were not included in this analysis due to decision to either continue with AI therapy or undergo surgery directly.|||percentage of patients||95% Confidence Interval|Number
2834107|NCT00265759|Primary|Clinical Response (Complete or Partial Response) Rate (Cohort A)|The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.|Up to 18 weeks||||percentage of patients||95% Confidence Interval|Number
2834108|NCT00265616|Secondary|Intubation Time in Survivors||Up to 3 months||||days||Full Range|Median
2834109|NCT00265616|Primary|Refractory Status Epilepticus Controlled With First Course of Study Drug|Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)|after return of continuous EEG activity (typically after 36 hours - 5 days)|Number of patients fulfilling primary outcome criteria|||participants|||Number
2834110|NCT00265616|Secondary|Patients With Propofol Infusion Syndrome|Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.|10 days||||participants|||Number
2834111|NCT00265616|Secondary|Patients With Hypotension Requiring Specific Treatment||10 days||||participants|||Number
2834114|NCT00265538|Other Pre-specified|Percent of Patients Taking a Thiazide at Baseline (Subgroup 2 at BP Goal and Taking a Calcium Channel Blocker)|This was a pre-specified sub-group of patients already at their blood pressure goal, so the primary outcome was taking a thiazide at baseline (index visit).|At index visit|The number of participants analyzed represents the number of participants with available data at each time point. This was a pre-specified sub-group and there for did not have the entire study population represented.|||Participants|||Count of Participants
2834115|NCT00265538|Primary|Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months|Reported in 2 sub-groups: Subgroup 1 not at BP goal; Subgroup 2 at BP goal but taking a calcium channel blocker (see pre-specified sub group analysis below).|index visit and 6 months|Total number of patients prescribed a thiazide at time of enrollment (index visit).|||Participants|||Count of Participants
2834116|NCT00265512|Secondary|Health Related Quality of Life|Physical and mental health subscales from the 12-item Medical Outcomes Study Short-form Health Survey, adapted for Veterans (VR-12). Observed scores on the MCS ranged from 2.89 to 70.39. Scores on the PCS ranged from 13.26 to 70.10. Higher scores denote better health. The minimum and maximum scores possible are 0 and 100, respectively.|3 months, 6 months and 12 months after randomization||||score on a scale||Standard Error|Mean
2834117|NCT00265512|Secondary|Psychiatric Symptoms|3 month, 6 month and 12 month measures of psychiatric symptoms, as measured by the Brief Symptom Inventory (BSI). Minimum observed score was 22; maximum observed score was 110. Higher score is worse. Minimum score possible is 22. Maximum score possible is 110.|Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization||||score on a scale||Standard Error|Mean
2834118|NCT00265512|Primary|Rates of Substance Use|Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).|Rates of substance use measured at 3 months||||percentage of days||Standard Error|Mean
2834119|NCT00265473|Secondary|Insulin Independent Multiple-donor Subjects.|Proportion of insulin independent multiple-donor subjects at one year after final transplant. Participant received more than one islet transplant.|At one year after final transplant||||participants|||Number
2834120|NCT00265473|Secondary|Insulin Independent Single-donor Subjects.|Proportion of insulin independent single-donor subjects at day 75 after transplant|At 75 days after transplant||||Participants|||Number
2834121|NCT00265473|Secondary|Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;|Proportion of subjects with partial islet function and no episodes of severe hypoglycemia at one year after initial islet transplant.|At one year after initial transplant||||Participants|||Number
2834122|NCT00265473|Primary|Serious Adverse Events Related to Immunosuppressive Therapy.|Number of serious adverse events related to immunosuppressive therapy.|Day 0 - Day 365||||Serious Adverse Events|||Number
2834123|NCT00265473|Primary|Subjects With Full Islet Function.|Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.|At one year after initial transplant.|The number of participants was based on the participants that were actually transplanted.|||Participants|||Number
2834124|NCT00265395|Primary|Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.|LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)|48 or 72 weeks of treatment plus 24 weeks of follow-up.|According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24).|||Participants|||Number
2834125|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||participants|||Number
2834126|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||participants|||Number
2834127|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||participants|||Number
2834128|NCT00265382|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834129|NCT00265382|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision."|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834130|NCT00265382|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834131|NCT00265382|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834132|NCT00265382|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834133|NCT00265382|Secondary|Change From Baseline in Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834134|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834156|NCT00265330|Primary|Change in Hormones|Mean Change: lab value at observation minus lab value at baseline|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)|||nanogram/deciliter (ng/dL)||Standard Deviation|Mean
2834209|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Erlotinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, t1/2 could not be accurately estimated.||||||
2834135|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834136|NCT00265382|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834137|NCT00265382|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.|||scores on a scale||Standard Deviation|Mean
2834138|NCT00265382|Secondary|Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment|Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 26, Early Termination (ET)|Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135.|||participants|||Number
2834139|NCT00265382|Primary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|26 weeks|Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.|||participants|||Number
2834140|NCT00265343|Secondary|Change in Quality of Life Measured by Quality of Life Scale (QLS)|Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population|||Units on a Scale||Standard Error|Least Squares Mean
2834141|NCT00265343|Primary|Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale|Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population|||Units on a Scale||Standard Error|Least Squares Mean
2834142|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF - All Subjects|QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)||||participants|||Number
2834143|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Females|QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)||||participants|||Number
2834144|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Males|QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)||||participants|||Number
2834145|NCT00265330|Primary|Mean Change From Baseline for QTcF Intervals|QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.|Baseline to Week 26 (end of study)||||millisecond||Standard Deviation|Mean
2834146|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 26||||participants|||Number
2834147|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6||||participants|||Number
2834148|NCT00265330|Primary|Mean Change From Baseline for Body Mass Index (BMI) Z-Score|mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6, 26, early termination||||score on scale||Standard Deviation|Mean
2834157|NCT00265330|Primary|Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol|Mean Change: lab value at observation minus lab value at baseline.|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)|||milligram /deciliter (mg/dL)||Standard Deviation|Mean
2834158|NCT00265330|Primary|Incidence of Lab Abnormalities|number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.|Week 26|Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115)|||participants|||Number
2834159|NCT00265330|Primary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).|baseline and 26 Weeks; 26 Weeks LOCF|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)|||score on scale||Standard Deviation|Mean
2834160|NCT00265330|Primary|Young Mania Rating Scale (YMRS) Total Score Change From Baseline|YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.|baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)|||score on scale||Standard Deviation|Mean
2834161|NCT00265317|Secondary|Plasma Concentration of Soluble KIT (sKIT) at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||pg/mL||Full Range|Median
2834162|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-3 at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||pg/mL||Full Range|Median
2834163|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-2 at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||pg/mL||Full Range|Median
2834164|NCT00265317|Secondary|Plasma Concentration of VEGF-C at Baseline||Baseline (Cycle 1, Day 1)|FA Set|||picograms (pg)/mL||Full Range|Median
2834165|NCT00265317|Secondary|Number of Participants on Anti-hypertensive Medications|Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.|Randomization to Day 28 of Cycle 18|Per Protocol Set; data were not analyzed||||||
2834166|NCT00265317|Secondary|Number of Participants With BP Greater Than 200/110 mmHg|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set|||Participants|||Number
2834167|NCT00265317|Secondary|Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set: all participants in the Phase 2 portion (randomized) who received at least 1 dose of study medication (either erlotinib or blinded medication) with treatment assignments designated according to actual study medication received|||Participants|||Number
2834168|NCT00265317|Secondary|EORTC-QLQ-C30 Lung Cancer Module (LC13) Score|The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)|PRO Analysis Set; n is number of participants with an assessment at the specific time point|||score on a scale||95% Confidence Interval|Mean
2834169|NCT00265317|Other Pre-specified|sKIT Ratio to Baseline at Each Timepoint|Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
2834170|NCT00265317|Secondary|Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score|EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1|Patient-Reported Outcome (PRO) Analysis Set: participants from the FA Set who had at least 1 EORTC QLQ-C30 or EORTC QLQ Lung cancer (QLQ-LC13) module questionnaire assessment while on treatment; n is number of participants with an assessment at the specified time point.|||score on a scale||95% Confidence Interval|Mean
2834171|NCT00265317|Other Pre-specified|VEGFR-3 Ratio to Baseline at Each Timepoint|Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
2835016|NCT00258180|Primary|Number of Participants With Treatment-free Remission at 1 Year After Study Completion|Number of participants off therapy 1 year after study completion without relapse.|1 year||||Participants|||Count of Participants
2834172|NCT00265317|Secondary|PFS in Subgroups That Were Defined by RNA Expression Profile|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834173|NCT00265317|Other Pre-specified|VEGFR-2 Ratio to Baseline at Each Timepoint|Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
2834174|NCT00265317|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
2834175|NCT00265317|Other Pre-specified|VEGF-C Ratio to Baseline at Each Timepoint|Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle|||Ratio||Full Range|Median
2834176|NCT00265317|Secondary|Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts|A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.|Baseline (Day 1, Cycle 1)|Blood samples were collected; however, because of the small sample size that resulted in a lack of power for statistical testing, no formal statistical analyses were performed.||||||
2834177|NCT00265317|Secondary|Percentage of Participants by Tumor VEGFR Mutation|Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|Full Analysis - All Population; data were not analyzed||||||
2834178|NCT00265317|Secondary|OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population|||Months||95% Confidence Interval|Median
2834179|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population|||Weeks||95% Confidence Interval|Median
2834180|NCT00265317|Secondary|Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms|Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.|Baseline|Full Analysis - All Population|||Percentage of Participants||95% Confidence Interval|Number
2834181|NCT00265317|Secondary|Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization until death (up to Month 17)|Per Protocol Caucasian Population|||Months||95% Confidence Interval|Median
2834182|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population: all Caucasian participants in randomized phase who received at least 1 dose of study medication (either erlotinib or blinded medication), with treatment assignments designated according to actual study medication received|||Weeks||95% Confidence Interval|Median
2834183|NCT00265317|Secondary|Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms|Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.|Baseline|Full Analysis - All Population: all participants from lead-in period and Phase 2 (randomized phase)|||Percentage of Participants||95% Confidence Interval|Number
2834184|NCT00265317|Secondary|PFS in Subgroups That Were Defined by KRAS Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834185|NCT00265317|Secondary|Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations|Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set|||Percentage of Participants|||Number
2834186|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834187|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Mutation|Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set|||Percentage of Participants|||Number
2834188|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Amplification|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834189|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Amplification|The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
2834190|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase|PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834191|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Copy Number Increase|The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.|Baseline|FA Set|||Percentage of Participants|||Number
2834192|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834193|NCT00265317|Secondary|Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)|Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
2834194|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834195|NCT00265317|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff|Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set|||Percentage of Participants|||Number
2834207|NCT00265317|Secondary|Erlotinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Number of participants with calculable data in Original Lead-In; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 24 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm A.|||Liters (L)/hr||Standard Deviation|Mean
2842389|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30||||L||Standard Error|Mean
2834196|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
2834197|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
2834198|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
2834199|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||ng/mL||Standard Deviation|Mean
2834200|NCT00265317|Secondary|Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||mcg/mL||Standard Deviation|Mean
2834201|NCT00265317|Secondary|Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above lower limit of quantification (LLOQ) in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle|||mcg/mL||Standard Deviation|Mean
2834202|NCT00265317|Secondary|Tmax for Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||Hours||Full Range|Median
2834203|NCT00265317|Secondary|Tmax for SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||Hours||Full Range|Median
2834204|NCT00265317|Secondary|Tmax for Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||Hours||Full Range|Median
2834205|NCT00265317|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A|||Hours||Full Range|Median
2834206|NCT00265317|Secondary|Sunitinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Number of participants with calculable data in Original Lead-In Cohort; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 48 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm B.|||L/hr||Standard Deviation|Mean
2834208|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Sunitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, t1/2 could not be accurately estimated.||||||
2834210|NCT00265317|Secondary|AUC(0-inf) for Total Drug (Sunitinib + SU-012662)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.||||||
2834211|NCT00265317|Secondary|AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.||||||
2834212|NCT00265317|Secondary|AUC(0-inf) for Sunitinib|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.||||||
2834213|NCT00265317|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib|AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf])|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, AUC(0-inf) could not be accurately estimated.||||||
2834214|NCT00265317|Secondary|Cmax of Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||ng/mL||Standard Deviation|Mean
2834215|NCT00265317|Secondary|Cmax of SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||ng/mL||Standard Deviation|Mean
2834216|NCT00265317|Secondary|Cmax of Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B|||ng/mL||Standard Deviation|Mean
2834217|NCT00265317|Secondary|Maximum Observed Plasma Concentration (Cmax) of Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A|||mcg/mL||Standard Deviation|Mean
2834218|NCT00265317|Secondary|AUC(0-24) of Total Drug (Sunitinib + SU-012662)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B|||ng*hr/mL||Standard Deviation|Mean
2834219|NCT00265317|Secondary|AUC(0-24) of SU-012662 (Metabolite of Sunitinib)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B|||ng*hr/mL||Standard Deviation|Mean
2834220|NCT00265317|Secondary|AUC(0-24) of Sunitinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B: participants received sunitinib for 28 days each cycle (13 days in Cycle 1) and erlotinib QD for 28 days each cycle (26 days in Cycle 1).|||nanograms (ng)*hr/mL||Standard Deviation|Mean
2834221|NCT00265317|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-in Cohort Arm A: participants received sunitinib QD for 28 days each cycle (27 days in Cycle 1) and erlotinib QD for 28 days each cycle (7 days in Cycle 1)|||micrograms (mcg)*hour(hr)/milliliter (mL||Standard Deviation|Mean
2834222|NCT00265317|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of participants alive at 1 year after date of first administration of study medication.|From randomization until death (up until Month 17)|FA Set|||Percentage of Participants|||Number
2834223|NCT00265317|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.|From randomization until death (up to Month 17)|FA Set|||Months||95% Confidence Interval|Median
2834224|NCT00265317|Secondary|Duration of Response (DR)|DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA subset of participants with a confirmed objective response were to be analyzed. As only 3 and 2 responses were observed, duration of response was not analyzed.||||||
2834225|NCT00265317|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Weeks||95% Confidence Interval|Median
2834240|NCT00265109|Secondary|Scores on Beck Anxiety Inventory|The Beck Anxiety Inventory (BAI) is a reliable, valid, and widely used 21-item self-report measure of anxiety during the past week which focuses on somatic symptoms.44 The BAI has been shown to be sensitive to change. Scores range from 0-63, with higher scores reflecting more severe symptoms.|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2842390|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24||||L||Standard Error|Mean
2834226|NCT00265317|Secondary|Percentage of Participants With Objective Response|Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set|||Percentage of Participants||95% Confidence Interval|Number
2834227|NCT00265317|Primary|Progression-Free Survival (PFS)|PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Full Analysis Set (FA):all participants in randomized phase randomized with study medication assignment designated according to initial randomization, regardless of whether participants actually received study medication or received different medication from what they were randomized.|||Weeks||95% Confidence Interval|Median
2834228|NCT00265239|Primary|Nonfatal Ischemic Stroke|number of nonfatal ischemic stroke|415days||||events|||Number
2834229|NCT00265239|Primary|Refractory Angina Pectoris|number of refractory angina pectoris|415days||||events|||Number
2834230|NCT00265239|Primary|Nonfatal Myocardial Reinfarction|number of nonfatal myocardial reinfarction|415days||||events|||Number
2834231|NCT00265239|Primary|Cardiac Death|number of cardiac death|415±32 days||||events|||Number
2834232|NCT00265200|Primary|Average Percent Change From Baseline in TRAP Levels at 2 Weeks|Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline|TRAP levels at Baseline and 2 weeks after first Zometa infusion|13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.|||Percent change||Full Range|Mean
2834233|NCT00265122|Secondary|Number of Participants in Population 1 With Clinical Remission at Week 8|The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.|||participants|||Number
2834234|NCT00265122|Secondary|Number of Participants in Population 2 With a Clinical Response at Week 8|The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.|||participants|||Number
2834235|NCT00265122|Primary|Number of Participants in Population 1 With a Clinical Response at Week 8|The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.|||participants|||Number
2834236|NCT00265109|Secondary|Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Short Form, is a 14-item reliable and valid measure that is sensitive to change. Transformed scores range from 0 from 100, with lower scores reflecting poorer quality of life.The Short Form transformed score is reported.|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2834237|NCT00265109|Secondary|Scores on Social and Occupational Functioning Scale (SOFAS)|The Social and Occupational Functioning Scale (SOFAS) is a global measure of psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2834238|NCT00265109|Secondary|Scores on Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a global measure of symptom severity and psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2834239|NCT00265109|Secondary|Scores on Social Phobia Inventory|The Social Phobia Inventory (SPIN) is a 17-item self-report questionnaire that assesses fear, avoidance, and physiological arousal associated with social anxiety during the past week. This scale is reliable, valid, and sensitive to change. Scores range from 0-68, with a score ≥19 distinguishing patients with social phobia from both healthy controls and psychiatric controls without social phobia.|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2842391|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24||||L||Standard Error|Mean
2834241|NCT00265109|Secondary|Scores on Hamilton Depression Rating Scale|The 24-item Hamilton Rating Scale for Depression (HAM-D 24) is a widely used reliable and valid clinician-administered measure of current severity of depressive symptoms. Scores range from 0 to 76, with higher scores reflecting more severe depressive symptoms.|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2834242|NCT00265109|Secondary|Scores on Clinical Global Severity|The 7-point Clinical Global Severity Scale assessed current illness severity at study baseline (score of 1=normal, not at all ill, and score of 7=among the most extremely ill patients).|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2834243|NCT00265109|Secondary|Scores on Brown Assessment of Beliefs Scale|The Brown Assessment of Beliefs Scale (BABS) is a 7-item semi-structured clinician-administered scale that assesses seven components of delusionality (insight) during the past week. Scores range from 0-24, with higher scores indicating greater delusionality. Beliefs are also categorized as delusional or nondelusional using an empirically derived cutpoint.|Pre- and post-treatment (week 12)||||units on a scale||Standard Deviation|Mean
2834244|NCT00265109|Secondary|Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.|"The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement."|Last week of treatment (week 12)||||Participants|||Count of Participants
2834245|NCT00265109|Secondary|Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms|"The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD."|Last week of treatment (week 12) or last week of treatment for early dropouts||||Participants|||Count of Participants
2834246|NCT00265109|Secondary|Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.|"The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement."|Last week of treatment (week 12)||||Participants|||Count of Participants
2834247|NCT00265109|Secondary|Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms|"The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from very much worse (score of 7) to very much improved (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD."|Last week of treatment (week 12) or last week of treatment for early dropouts||||Participants|||Count of Participants
2834248|NCT00265109|Primary|Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)|The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0-48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.|Baseline to end week 12|Analyses of the primary outcome measure were intention to treat (ITT) analyses.|||Participants|||Count of Participants
2834249|NCT00265096|Secondary|American College of Rheumatology 20 at Week 24|"Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24.~ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])"|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|ITT. Patients considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. Wk 16 ACR response was used for patients with change in study treatment.|||P a r t i c ip an t s|||Number
2834250|NCT00265096|Primary|Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24|Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage.|Baseline and Week 24|Intent-to-treat analysis.|||Scores on a scale||Standard Deviation|Mean
2834251|NCT00265096|Secondary|Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14|The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Baseline and Week 14|Intention to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
2834252|NCT00265096|Secondary|Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24|Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|Intention to treat (ITT). Missing scores were imputed by LOCF. Week (Wk) 16 scores were used for patients with change in study treatment. Week 16 HAQ scores were used for patients with change in study treatment.|||scores on a scale||Inter-Quartile Range|Median
2834253|NCT00265096|Secondary|Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline|Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.|Baseline, Week 4, Week 8 and Week 14|In a subset of patients with ≥ 3 percent body surface area (BSA) psoriasis skin involvement at baseline. Missing scores were imputed by Last Observation Carried Forward (LOCF).|||Participants|||Number
2834254|NCT00265096|Primary|American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])|Baseline (Week 0), Week 4, Week 8 and Week 14|Intention to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
2834255|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14|The Bath Ankylosing Spondylitis Metrology Index (BASMI) is the sum of scores comprised of 5 measures (0=mild, 1=moderate & 2=severe): Tragus-to-wall; Lumbar flexion; Cervical rotation; Lumbar side flexion; Intermalleolar distance. BASMI ranges from 0 to 10. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASMI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASMI at Week 14 was imputed by Last Observation Carried Forward (LOCF).|||Change from baseline in BASMI Index||Standard Deviation|Mean
2834256|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14|The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the mean of 10 VAS, each of length 0 to 10 cm. Eight of the scales relate to functional capacity of patients while the other 2 relate to a patient's ability to cope with everyday life. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASFI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASFI at Week 14 was imputed by Last Observation Carried Forward (LOCF).|||Change from baseline in BASFI Index||Inter-Quartile Range|Median
2834257|NCT00265083|Secondary|Assessment in Ankylosing Spondylitis 20 Responders at Week 24|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 24 at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 24|ITT. Patients (pts) considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ASAS components were imputed by LOCF unless all ASAS components are missing in which case considered non-responders. Wk 16 ASAS response was used for pts with change in study treatment.|||P a r t i c ip an t s|||Number
2834258|NCT00265083|Primary|Assessment in Ankylosing Spondylitis 20 Responders at Week 14|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ASAS components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ASAS components are missing in which case considered non-responders.|||Participants|||Number
2834259|NCT00264875|Primary|Mean Visual Analogue Scale (VAS) Pain Scores|"Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.~Endpoint = last non-missing observation carried forward after Baseline visit."|Baseline, Week 4, Week 8, Week 12, and Endpoint|The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.|||score on scale||Standard Deviation|Mean
2834260|NCT00264849|Secondary|Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems|The Work Productivity and Activity Impairment-Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Overall work impairment due to asthma problems is derived from the proportion of hours missed from work due to asthma and the degree to which asthma problems affected productivity while working.|Baseline and Week 31|Modified Intent-to-Treat. Only patients only who worked and with values at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.|||percent impairment||Standard Deviation|Mean
2834261|NCT00264849|Secondary|Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31|"The utility-based EQ-5D questionnaire is in two parts and provides a generic measure of health for clinical and economic appraisal. The first health state classification part has 5 questions each with 3 categories (no problem, moderate problem, severe problems). The second visual analogue scale was measured from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline, Week 15, Week 31|Modified Intent-to-Treat with N count as noted in category description.|||units on a scale||95% Confidence Interval|Least Squares Mean
2834309|NCT00264303|Secondary|Mean Pruritus Severity Score Over the Four Weeks of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
2834262|NCT00264849|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit|There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|Baseline, Week 15, Week 31|mITT at Week 15 for OAT + Omalizumab is 214 patients and for OAT is 92 patients; at Week 31 for OAT + Omalizumab is 224 patients and for OAT is 97 patients except as noted in the category description. To be included in this table patients must have a AQLQ measurement for the specified timepoint.|||units on a scale||95% Confidence Interval|Least Squares Mean
2834263|NCT00264849|Secondary|Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32|The type of change for the dose of maintenance systemic steroids could be presented as removal (no more maintenance systemic steroids used), decreased, or maintained.|Weeks 16 and 32|mITT patients with systemic steroids at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6).|||participants|||Number
2834264|NCT00264849|Secondary|Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32|For the subgroup of patients requiring maintenance oral (systemic) corticosteroids throughout the screening period the dose of oral steroid (expressed as prednisolone equivalent dose) at baseline, Week 16 and Week 32 was presented by treatment group, as well as the absolute and percent change from baseline to Weeks 16 and 32. It should be noted that the dose of oral steroid at Weeks 16 and 32 was the dose the patient was maintained on and not the dose to treat an exacerbation if one occurred at that time.|Weeks 16 and 32|mITT patients with systemic steriods at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6). N counts as noted in the category description.|||percent change||Standard Deviation|Mean
2834265|NCT00264849|Secondary|Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period|A combined total of unscheduled visits due to asthma exacerbations was calculated for each patient as the total number of hospital admissions, ER visits and unscheduled outpatient clinical visits due to asthma exacerbation. Where more than one type of visit was required on a single day for an asthma exacerbation only the most serious type was included. Where there was more than one visit for a single asthma exacerbation but the visits occurred on different dates, then all were counted.|32 Weeks|Modified Intent-to-Treat (mITT)|||participants|||Number
2834266|NCT00264849|Secondary|Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period|A clinically significant exacerbation episode was defined as a worsening of asthma requiring treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the rescue systemic corticosteroids marked the start of a clinically significant asthma exacerbation episode and cessation of the rescue systemic corticosteroids regimen marked the end of a clinically significant exacerbation episode. If an exacerbation episode was duplicated, overlapped by at least one day with another episode, or nested within another exacerbation episode, only one exacerbation was counted.|32 Weeks|mITT|||participants|||Number
2834267|NCT00264849|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.|Baseline, Week 16, Week 32|mITT with N counts as noted in the category description. To be included in this table patients must have a ACQ measurement for the specified timepoint.|||units on a scale||95% Confidence Interval|Least Squares Mean
2834268|NCT00264849|Secondary|Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)|Predicted FEV1 was calculated using the Crapo formula for data at Visit 6 (time of randomization), (MALES: Predicted FEV1 (L) = 0.0414*height - 0.0244*age -2.190 and Females: Predicted FEV1 (L) = 0.0342*height - 0.0255*age - 1.578, where height is in cm).|Weeks 16 and 32|Modified Intent-to-Treat (mITT), for Week 16 N=258/106 for OAT+Omalizumab/OAT and for Week 32 N=266/121 for OAT+Omalizumab/OAT, respectively.|||percent predicted FEV1||95% Confidence Interval|Least Squares Mean
2834269|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE|Responders were defined as excellent or good based on the patient's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|mITT population and patients who were assessed for persistency of response or non-response at Week 16 and had a GETE obtained >= 4 weeks after the Week 16 assessment or discontinued prematurely or unsatisfactory therapeutic effect >= 4 weeks after the Week 16 assessment. N=187/28 for OAT+Omalizumab/OAT for responders and N=71/63 for non-responders.|||percentage of participants||95% Confidence Interval|Number
2834270|NCT00264849|Secondary|Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32|Number of participants with persistent response, based on the patient's GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. This is based on the patient's evaluation.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)|||participants|||Number
2834271|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE|Responders were defined as excellent or good based on the investigator's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)|||percentage of participants||95% Confidence Interval|Number
2842392|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18||||L||Standard Error|Mean
2834272|NCT00264849|Secondary|Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32|Number of participants with persistent response, based on the investigator's GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)|||participants|||Number
2834273|NCT00264849|Primary|Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)|Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.|Weeks 16 and 32|Modified Intent-to-Treat (mITT) was defined for efficacy analyses which included all randomized patients who had at least one post-baseline efficacy assessment.|||participants|||Number
2834274|NCT00264810|Primary|Change in Frequency of Disabling Seizures|"The outcome measure is met when a significantly greater reduction in the frequency of total disabling seizures in seen in the Treatment group when compared to the Sham group, during the Blinded Evaluation Period (BEP) relative to the Pre-Implant Period (Baseline).~The outcome measure is the group-by-time interaction term in a generalized estimating equation (GEE), longitudinal regression model, where group refers to therapy allocation (Treatment or Sham), time refers to study period (Baseline or BEP), and the dependent variable is seizure frequency. The outcome measure was a statistically significant group-by-time interaction term, which would demonstrate a significantly greater reduction in seizure frequency in the Treatment group than the Sham group during BEP compared to Baseline Period.~Primary Effectiveness Outcome Measure was met.~(Note: Disabling seizures = motor simple partial seizures or complex partial seizures with or without secondarily generalized seizures.)"|3 months pre-implant (Baseline Period) compared to months 3, 4 and 5 post-implant (Blinded Evaluation Period)||||Seizure frequency % change from Baseline||95% Confidence Interval|Number
2834275|NCT00264810|Primary|Short-term Chronic SAE Rate|"RNS® System Short-term Chronic SAE rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 42%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Oh et al., 2002; SSED, Activa Tremor Control System P960009; Beric et al., 2001; Behrens et al., 1997; Hariz, 2002; Joint et al., 2002; Koller et al., 2001).~Primary Safety Outcome Measure was met."|Initial implant through 5 months post-implant||||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
2834276|NCT00264810|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 15%; upper CI = 20%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Tanriverdi et al., 2009; Wong et al., 2009; Fountas and Smith, 2007; Hamer et al., 2002; Behrens et al., 1997).~Primary Safety Outcome Measure was met."|Initial implant through 1 month post-implant||||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
2834277|NCT00264797|Secondary|Substance Use Outcomes|The mean number of negative urine drug screens (UDS).|20 weeks|All randomized participants.|||negative UDS||Standard Deviation|Mean
2834278|NCT00264797|Secondary|OROS-MPH Abuse Liability|Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.|20 weeks|All randomized participants.|||pills||Standard Deviation|Mean
2834279|NCT00264797|Primary|Substance Use|The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.|20 weeks|All randomized participants.|||days||95% Confidence Interval|Mean
2834280|NCT00264797|Primary|ADHD Severity|DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.|baseline and 20 weeks|All randomized participants.|||units on a scale||Standard Deviation|Mean
2834281|NCT00264641|Primary|Cerebral Activation During Hypoglycaemia|To compare the high RAS activity vs low RAS activity a Z score was used.|After 4 scans on day 1|Only data available is between group analysis|||Z score|||Number
2834282|NCT00264576|Secondary|Number of Subjects Reporting Local and Systemic Reactions|"Safety and tolerability of cTIV and eTIV_f postvaccination.~Difference between demography and safety numbers was due to one misrandomization."|7 days postvaccination|Analysis was done on safety set|||Subjects|||Number
2834283|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
2834284|NCT00264576|Secondary|Percentages of Subjects With Seroconversion.|As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is >40%.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages||95% Confidence Interval|Number
2834285|NCT00264576|Secondary|Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.|"Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay.~This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Percentages||95% Confidence Interval|Number
2834286|NCT00264576|Secondary|Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method|Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
2834287|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Ratio||95% Confidence Interval|Geometric Mean
2834288|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Ratio||95% Confidence Interval|Geometric Mean
2834289|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set|||Titer||95% Confidence Interval|Geometric Mean
2834290|NCT00264550|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24|The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group|||Units on a scale||Inter-Quartile Range|Median
2834291|NCT00264550|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 14|All participants randomly assigned to each treatment group|||Units on a scale||Inter-Quartile Range|Median
2834292|NCT00264550|Secondary|Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 24|All participants randomly assigned to each treatment group|||Participants|||Number
2834293|NCT00264550|Primary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24|HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group|||Units on a scale||Inter-Quartile Range|Median
2834294|NCT00264550|Secondary|Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14|DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).|Week 14|All participants randomly assigned to each treatment group|||Participants|||Number
2834308|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the First Week of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.|over the first week of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
2834295|NCT00264550|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 14|All participants randomly assigned to each treatment group|||Participants|||Number
2834296|NCT00264537|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group who had C-reactive protein > 1.0 mg/dl at baseline.|||Scores on a scale||Standard Deviation|Mean
2834297|NCT00264537|Primary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group.|||Scores on a scale||Standard Deviation|Mean
2834298|NCT00264537|Secondary|Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Randomized participants with abnormal baseline CRP. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||Participants|||Number
2834299|NCT00264537|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||Participants|||Number
2834300|NCT00264537|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.|||Participants|||Number
2834301|NCT00264498|Primary|Progression Free Survival (PFS)|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression|Date of randomization to earliest date of objective disease progression||||Days||95% Confidence Interval|Mean
2834302|NCT00264381|Secondary|Change From Baseline to Day 14 in Pain Assessment|Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain|Day 1, Day 14|Participants available at follow up|||units on a scale||Standard Deviation|Mean
2834303|NCT00264381|Primary|Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months|Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.|3 months|Participants available for follow up|||participants|||Number
2834304|NCT00264381|Primary|Thrombosis Progression and Venous Thromboembolism (VTE)|Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing|Day 14|Total number available for follow up|||participants|||Number
2834305|NCT00264381|Secondary|Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.|Number of participants with bleeding events related to treatment|3 months||||participants|||Number
2834306|NCT00264303|Primary|Mean Pruritus Severity Score Over the First Week of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.|over the first week of treatment|ITT population|||Units on a scale||Standard Error|Least Squares Mean
2834307|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the Four Weeks of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
2835723|NCT00249249|Secondary|Apolipoprotein B (Apo B)|Apolipoprotein B at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/dL||Standard Deviation|Mean
2834310|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment|CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population|||Units on a scale||Standard Error|Least Squares Mean
2834311|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment|CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment.|over the first week of treatment|Intent to treat (ITT) population|||Units on a scale||Standard Error|Least Squares Mean
2834312|NCT00264290|Secondary|Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period||Week 12|||||||
2834313|NCT00264290|Secondary|Change in CMV DNA Shedding After a 4-week Washout Period||Week 12|||||||
2834314|NCT00264290|Secondary|%CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period||Week 12|||||||
2834315|NCT00264290|Secondary|Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8.||week 8|||||||
2834316|NCT00264290|Secondary|Change in CMV DNA Shedding From Baseline to Week 8.|Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.|week 8|||||||
2834317|NCT00264290|Primary|Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.|The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.|Baseline, 8 weeks||||percentage of activated T cells||95% Confidence Interval|Mean
2834318|NCT00264238|Secondary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2834319|NCT00264238|Primary|Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)|The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2834320|NCT00264147|Secondary|Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treated Population|||Units on a Scale||Standard Deviation|Mean
2834321|NCT00264147|Secondary|Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0 indicates very well, 4 indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population|||Units on a Scale||Standard Deviation|Mean
2834322|NCT00264147|Secondary|Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All Patients-Treated Population|||Units on a Scale||Standard Deviation|Mean
2834323|NCT00264147|Secondary|Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population|||Swollen Joint Count||Standard Deviation|Mean
2834324|NCT00264147|Secondary|Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population|||Tender Joint Count||Standard Deviation|Mean
2834325|NCT00264147|Primary|Proportion of Patients Who Met the ACR20 Responder Index Criteria|Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)|12 weeks|All-Patients-Treated Population|||Proportion of Patients|||Number
2834326|NCT00264004|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.|Randomisation until end of treatment period||||percentage of tumor size||90% Confidence Interval|Geometric Mean
2834327|NCT00264004|Secondary|Objective Response Rate|Number of patients with complete or partial response (CR/PR), based on RECIST|12 week treatment period||||Participants|||Number
2834328|NCT00264004|Secondary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171||First 6 weeks of 12 week treatment period||||Participants|||Number
2834367|NCT00263588|Secondary|Overall Survival (OS)|Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause.|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|Lapatinib Monotherapy MITT|||months||95% Confidence Interval|Median
2834329|NCT00264004|Primary|Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171|Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)|12 week treatment period||||Poportion of Planned Dose||90% Confidence Interval|Median
2834330|NCT00264004|Primary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171||12 week treatment period||||Participants|||Number
2834331|NCT00263887|Secondary|Quality of Life With a Disease Specific Instrument, the St. George's Respiratory Questionnaire||24 or 30 months|||||||
2834332|NCT00263887|Secondary|Mortality||24 or 30 months|||||||
2834333|NCT00263887|Secondary|Duration and Severity of the Exacerbations||24 or 30 months|||||||
2834334|NCT00263887|Secondary|The Deterioration of the Lung Function Will be Assessed by Measurement of the Change in Forced Expiratory Volume at One Second (FEV1) and Transfer Factor of Carbon Monoxide (KCO)||24 or 30 months|||||||
2834335|NCT00263887|Secondary|The Frequency of Exacerbations as Determined by Patient Diary.||24 or 30 months|||||||
2834336|NCT00263887|Secondary|Change in Lung Density at Each Visit as Measured by Computed Tomography||24 or 30 months|||||||
2834337|NCT00263887|Primary|The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung||24 or 30 months|The modified Intent-To-Treat Population was defined as all subjects in the Intent-To-Treat (ITT) Population (all randomized subjects) who had a valid baseline CT scan and at least one valid post-baseline CT scan measurement.|||g/L||Standard Deviation|Mean
2834338|NCT00263757|Secondary|Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, some due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, due to withdrawals."|||units on a scale||Standard Deviation|Mean
2834339|NCT00263757|Secondary|Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit|The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the ESS, and at the 12 month visit 6 participants completed the ESS, due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the ESS, and at the 12 month visit 5 participants completed the ESS, due to withdrawals."|||units on a scale||Standard Deviation|Mean
2834340|NCT00263757|Primary|Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year||1 year||||participants|||Number
2834341|NCT00263666|Secondary|Number of Subjects With the RV in Stool Samples|Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type and results not available [NA]).|From Dose 1 until post Dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available|||Participants|||Count of Participants
2834342|NCT00263666|Secondary|Enteric Pathogens Identification.|Number of gastroenteritis (GE) episodes classified by enteric pathogen tests results.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the subjects from the Total Vaccinated Cohort with gastroenteritis episodes reported between the first dose and the last visit and for whom stools were collected|||number of GE episodes|||Number
2834343|NCT00263666|Secondary|Rotavirus Vaccine Strain Identification.|"Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype.~Unknown: These samples were typed post hoc and found G1P8 vaccine type for one subject in HRV group, G3P8 and G2P4 for subjects in placebo group."|From dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort.|||Number of episodes|||Number
2834344|NCT00263666|Secondary|Rotavirus in Diarrheal Stool Samples|Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort|||Number of episodes|||Number
2834345|NCT00263666|Secondary|Rotavirus Antigen Excretion in Stool Samples|Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end|At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the According to Protocol Cohort for immunogenicity.|||Participants|||Count of Participants
2834346|NCT00263666|Secondary|Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.||Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity|||titer||95% Confidence Interval|Geometric Mean
2834347|NCT00263666|Secondary|Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value|The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
2834348|NCT00263666|Secondary|Geometric Mean Concentration for Anti-BPT Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||ELISA-Units/milliliter||95% Confidence Interval|Geometric Mean
2842393|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18||||L||Standard Error|Mean
2834349|NCT00263666|Secondary|Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter(EL.U/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
2834350|NCT00263666|Secondary|Geometric Mean Concentration for Anti-HBs Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||Milli International Units/milliliter||95% Confidence Interval|Geometric Mean
2834351|NCT00263666|Secondary|Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
2834352|NCT00263666|Secondary|Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||International Units / milliliter||95% Confidence Interval|Geometric Mean
2834353|NCT00263666|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL)|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.|||Participants|||Count of Participants
2834354|NCT00263666|Secondary|Geometric Mean Concentration for Anti-PRP Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
2834355|NCT00263666|Secondary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.|Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).|Two months after dose 3|The analysis was performed on the According To Protocol Cohort for immunogenicity|||Participants|||Count of Participants
2834356|NCT00263666|Secondary|Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.|Two months after dose 3|"The analysis was performed on the According To Protocol Cohort for immunogenicity for whom data were available.~In the placebo group, GMCs were all < 20 U/ml, hence values were not computed."|||Units/milliliter||95% Confidence Interval|Geometric Mean
2834357|NCT00263666|Secondary|Number of Subjects With Vaccine Take.|Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.|Two months after the dose 3|Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available|||Participants|||Count of Participants
2834358|NCT00263666|Secondary|Number of Subjects Who Seroconverted Against Rotavirus|A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.|Two months after dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available|||Participants|||Count of Participants
2834359|NCT00263666|Secondary|Human Immunodeficiency Virus (HIV) Viral Load|Mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).|At the screening visit and 2 months after dose 3.|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.|||base-10 logarithm of copies/milliliter||Standard Deviation|Mean
2834360|NCT00263666|Secondary|The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.|Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.|At the screening visit and 2 months after dose 3 (Visit 4).|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2834361|NCT00263666|Secondary|Number of Subjects Reporting Each Type of Solicited Symptom.|Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.|Within the 15-day solicited follow-up period after each dose|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2834362|NCT00263666|Secondary|Number of Subjects Reporting Any Serious Adverse Events.|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3).|Analysis was performed on the Total Vaccinated Cohort|||Participants|||Count of Participants
2834363|NCT00263666|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms.|An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 30 days after each dose|Analysis was performed on the Total Vaccinated Cohort|||Participants|||Count of Participants
2834364|NCT00263666|Primary|"Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea."|"Symptoms reported in the table include:~Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day."|Within the 15-day solicited follow-up period after any dose.|The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2834365|NCT00263588|Secondary|Primary Cause of Death|Summary of Overall All-cause mortality (Main Study and Extension)|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|ITT|||Participants|||Count of Participants
2834366|NCT00263588|Secondary|Summary of Site of First Progression|baseline to time of disease progression or death|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|MITT|||Participants|||Count of Participants
2834369|NCT00263588|Secondary|Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy|The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24|from Start of lapatinib to 6 months|MITT|||percentage of participants||95% Confidence Interval|Number
2834370|NCT00263588|Secondary|Duration of Central Nervous System (CNS) Objective Response|"The duration of CNS objective response, defined as the time from first CNS~Objective response until tumor progression at any site or death due to any cause.~A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms."|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|Lapatinib monotherapy MITT|||months||95% Confidence Interval|Median
2834371|NCT00263588|Secondary|Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)|Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS|baseline and weeks 8, 16, 24, 32, 40, 48|MITT|||percentage of participants||95% Confidence Interval|Number
2834372|NCT00263588|Secondary|Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet|Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, & ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline & each 4 wks. Categories below are not mutually exclusive.|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|"MITT population~Analysis was performed on combined cohorts in order to have a sufficient sample size to analyze association of CNS Volumetric Change from Baseline and NSS Improvement"|||Participants|||Count of Participants
2834373|NCT00263588|Primary|The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)|Summary of CNS Objective Response (the Complete Response + Partial Response)|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|Modified ITT (MITT) Population is defined as all subjects who received at least four doses (750 mg lapatinib 2x daily for 2 days) of study medication and who had measurable brain metastases (greater than or equal to 1cm in diameter) at baseline assessment. MITT was the primary population for analysis of efficacy data in lapatinib monotherapy arm.|||percentage of participants||95% Confidence Interval|Number
2834374|NCT00263588|Primary|The Number of Participants With Central Nervous System (CNS) Best Overall Response|"Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)~Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.~The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)~A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms"|time from baseline to data cutoff (25 Sept 2007); approximately 2 years|Modified ITT (MITT) Population is defined as all subjects who received at least four doses (750 mg lapatinib 2x daily for 2 days) of study medication and who had measurable brain metastases (greater than or equal to 1cm in diameter) at baseline assessment. MITT was the primary population for analysis of efficacy data in lapatinib monotherapy arm.|||Participants|||Count of Participants
2834375|NCT00263328|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire|HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||events||Standard Deviation|Mean
2834376|NCT00263328|Secondary|Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
2834377|NCT00263328|Secondary|End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
2835724|NCT00249249|Secondary|Non-HDL:HDL Ratio|Ratio of non-HDL to HDL at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||||Standard Deviation|Mean
2834378|NCT00263328|Secondary|Change From Baseline in SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
2834379|NCT00263328|Secondary|SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
2834380|NCT00263328|Secondary|Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety population per visit with non-missing value.|||scores on a scale||Standard Deviation|Mean
2834381|NCT00263328|Secondary|Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale|"The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.|||score on a scale||Standard Deviation|Mean
2834382|NCT00263328|Secondary|Trough Levels of Tacrolimus (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ng/mL||Standard Deviation|Mean
2834383|NCT00263328|Secondary|Tofacitinib Concentrations in Plasma (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ng/mL||Standard Deviation|Mean
2834384|NCT00263328|Secondary|Fasting Serum Glucose Levels (mg/dL) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2834385|NCT00263328|Secondary|HOMA Insulin Resistance (IR) by Visit|HOMA-IR=fasting serum insulin*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.|||HOMA-IR||Standard Deviation|Mean
2834386|NCT00263328|Secondary|AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit|The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.|||microU*h/mL||Standard Deviation|Mean
2834387|NCT00263328|Secondary|Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit|Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit.|||mg*h/dL||Standard Deviation|Mean
2834388|NCT00263328|Secondary|Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit|Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit.|||ratio of serum proinsulin to insulin||Standard Deviation|Mean
2834389|NCT00263328|Secondary|Homeostatic Model Assessment (HOMA)-%B by Visit|HOMA-%B = (20 times [*] fasting serum insulin) divided by (/) (fasting serum glucose minus [-] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit.|||%B||Standard Deviation|Mean
2834390|NCT00263328|Secondary|Hemoglobin A1c (HbA1c) Levels by Visit||Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||% HbA1c||Standard Deviation|Mean
2842394|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12||||L||Standard Error|Mean
2834392|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit|Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834393|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit|Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834394|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit|Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for â‰¥6 consecutive weeks, or death.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834395|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit|Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834396|NCT00263328|Secondary|Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Months 12, 18, 24, 36, 48, 60, 72, 84, and 96|FAS|||percentage of participants|||Number
2834397|NCT00263328|Secondary|Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR|Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.|Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)|FAS|||percentage of participants|||Number
2834398|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit|Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834399|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit|Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834400|NCT00263328|Secondary|Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834401|NCT00263328|Secondary|BK Virus (BKV) DNA Levels Determined Using PCR by Visit|Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||number of copies/PCR||Standard Deviation|Mean
2834402|NCT00263328|Secondary|Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and >1000 copies/PCR.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834403|NCT00263328|Secondary|Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit|Calculated as number of copies per 500 mg DNA.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||number of copies/500 mg DNA||Standard Deviation|Mean
2834404|NCT00263328|Secondary|Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834405|NCT00263328|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834406|NCT00263328|Secondary|Percentage of Participants Requiring Lipid-Lowering Agents by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834407|NCT00263328|Secondary|Serum Triglyceride Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2834408|NCT00263328|Secondary|Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834409|NCT00263328|Secondary|Ratio of Serum LDL Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ratio||Standard Deviation|Mean
2834410|NCT00263328|Secondary|Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834411|NCT00263328|Secondary|Ratio of Total Serum Cholesterol Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||ratio||Standard Deviation|Mean
2834412|NCT00263328|Secondary|High-Density Lipoprotein (HDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2834413|NCT00263328|Secondary|Low-Density Lipoprotein (LDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2834414|NCT00263328|Secondary|Total Cholesterol Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2834415|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit|Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels â‰¥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose â‰¥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose â‰¥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis.|||percentage of participants|||Number
2834416|NCT00263328|Secondary|Reciprocal of Serum Creatinine||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||dL/mg||Standard Deviation|Mean
2834417|NCT00263328|Secondary|Calculated GFR Using Cockcroft-Gault Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
2834418|NCT00263328|Secondary|Calculated GFR Using the Nankivell Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine [in millimoles per liter (mmol/L)]) plus (0.25*body weight [in kilograms (kg)]) minus (0.5*serum urea [mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea]) minus (100 per height [in meters] square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
2834419|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit|Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834420|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit|Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834421|NCT00263328|Primary|Percentage of Participants With Hypertriglyceridemia by Visit|Hypertriglyceridemia was defined as triglyceride levels of >200 mg/dL or 2.3 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834422|NCT00263328|Primary|Percentage of Participants With Hypercholesterolemia|Hypercholesterolemia was defined as cholesterol levels >240 mg/dL or 6.2 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2834423|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit|Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (â‰¥)30 days.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834424|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit|Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.|||percentage of participants|||Number
2834425|NCT00263328|Primary|Serum Creatinine Levels||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
2834426|NCT00263328|Primary|Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine [in milligrams per deciliter (mg/dL)])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen [BUN] concentration [mg/dL])^(-0.170) * (serum albumin concentration [in grams per dL (g/dL)])^(0.318). A normal GFR is >90 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
2834427|NCT00263211|Secondary|Progression Free Survival||Maximum of 6 months|This trial was terminated early due to futility, subjects were not followed for progression free-survival.||||||
2834428|NCT00263211|Secondary|Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups|Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups|Baseline, 2 weeks and 1 month|Mean Platelet inhibition Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for control group baseline n=24 , 2-weeks n=19, 1 month n=23|||percentage of platelet inhibition||Standard Deviation|Mean
2834429|NCT00263211|Secondary|Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups|Mean platelet inhibition vs. time plotted for Plavix & Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).|Baseline, 2 weeks and 1 month|Denominator for Plavix & Aspirin arm baseline n=22, 2 weeks n=20, 1 month n=19 Denominator for Observation only arm baseline n=24 , 2-weeks n=19, 1 month n=23|||Aspirin Reaction Units||Standard Deviation|Mean
2835725|NCT00249249|Secondary|Triglycerides (TG)|mean triglycerides at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/dL||Standard Deviation|Mean
2834430|NCT00263211|Secondary|Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time|Percent of patients with a given number/range of CTCs ( 0, 1-5 >+ 5) vs. time baseline 2-weeks and 1 month for plavix & Aspirin arm and observation only|Baseline, 2 weeks and 1 month|Denominator for Plavix & Aspirin arm at Baseline=22, at 2 weeks =20, at 4 weeks =19 Denominator for Observation only at Baseline=24, at 2 weeks=19, at 4 weeks =23|||percentage of participants|||Number
2834431|NCT00263211|Primary|Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug|Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.|Maximum of 6 months|Plavix and Aspirin: 1 patient withdrew consent prior to starting 1 patient died prior to starting|||participants|||Number
2834432|NCT00263211|Primary|Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs|Measured by number of patients who have detectable circulating tumor cells|Week 4|Plavix & Aspirin arm has 19 evaluable patients. 5 withdrew before 1-month data collection: death n=1 and withdrawal of consent n=1 prior to starting; surgery plans n=1; patient preference n=1; platelet inhibition use n=1; Observation only arm had 23 evaluable patients ; 1 patient withdrew during the first month due to disease progression.|||participants|||Number
2834433|NCT00262964|Primary|Change From Baseline in Hepatic Insulin Sensitivity Index|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index (HISI) is measured as the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
2834434|NCT00262964|Primary|Change From Baseline in Skeletal Muscle Insulin Sensitivity|Changes in skeletal muscle insulin sensitivity (SMIS). SMIS was measured as the increase in skeletal muscle glucose uptake from time zero to the end of a nine hour euglycemic clamp and insulin infusion study. This increase is the percentage change from time zero to end of insulin infusion at nine hours.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||percent increase||Standard Error|Mean
2834435|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity in Fenofibrate and Niacin Groups|The baseline and post-treatment measures of adipose tissue insulin sensitivity (ATIS) were compared. ATIS at both timepoints is the suppression from fasting levels of free fatty acid release from adipose tissue (lipolysis) during an insulin infusion as part of a euglycemic clamp study. It is the percent decrease from time zero to the end of the nine hour euglycemic hyperinsulinemic clamp|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)||||percent decrease||Standard Error|Mean
2834436|NCT00262964|Secondary|Change From Baseline in Very Low-density Lipoprotein Triglyceride Concentration|Change from baseline in very low-density lipoprotein triglyceride concentration (VLDL-Tg)|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||mmol/l||Standard Error|Mean
2834437|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Production Rate|VLDL-TG production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||(μmol/L/min)||Standard Error|Mean
2834438|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Clearance Rate|Very low density lipoprotein triglyceride (VLDL-Tg) clearance rate, a measure of VLDL-triglyceride removal from plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)||||(ml/min)||Standard Error|Mean
2834439|NCT00262964|Secondary|Change From Baseline in Very Low Density Lipoprotein Apolipoprotein B Production Rate|VLDL-apolipoprotein B (apoB) concentrations were measured as part of a VLDL metabolism study utilizing stable isotope tracers. VLDL apoB production rate, a measure of hepatic secretion of VLDL-apolipoproteinB-100 per liter of plasma per minute.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)||||nmol/l/min||Standard Error|Mean
2834440|NCT00262964|Primary|Hepatic Fat Content for Fenofibrate and Niacin Groups|Hepatic fat content as measured by magnetic resonance spectroscopy. A PRESS sequence was used. The results from three 10 cubic centimeter voxels positioned within the liver were averaged. The measure is a ratio of triglyceride signal to total signal.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|10 (or more) subjects in each group would be sufficient for detecting changes in IHTG.|||ratio||Standard Deviation|Mean
2834441|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity|The ability of insulin to suppress the release of fatty acids from adipose tissue: Adipose tissue insulin sensitivity, measured as the suppression from baseline of free fatty acid release from adipose tissue (lipolysis) during insulin infusion as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp||||percent decrease||Standard Error|Mean
2834442|NCT00262964|Primary|Percent Increase in Skeletal Muscle Insulin Sensitivity During Insulin Infusion.|A precise measure of the ability of insulin to stimulate glucose uptake by skeletal muscle. Skeletal muscle insulin sensitivity, measured as the increase from baseline in skeletal muscle glucose uptake during insulin infusion(percentage)as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp||||percent increase||Standard Error|Mean
2834443|NCT00262964|Secondary|Very Low Density Lipoprotein - Triglyceride Production Rate|Very low density lipoprotein triglyceride (VLDL-TG) production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute (μmol/L/min).|baseline cross-sectional data||||μmol/L/min||Standard Error|Mean
2834444|NCT00262964|Primary|Hepatic Insulin Sensitivity Index (HISI)|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline cross-sectional data|number of subjects determined by power calculations. Analysis was per protocol. Intrahepatic triglyceride was determined by magnetic resonance spectroscopy.|||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
2834446|NCT00262951|Primary|Number of Patients in Whom Tumor Was Resectable|Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.|Up to 5 Years or Until Disease Progression||||Participants|||Number
2834447|NCT00262925|Secondary|Overall Survival|Time from registration to death from any cause. Patients alive were censored at follow up.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry||||months||95% Confidence Interval|Median
2834448|NCT00262925|Primary|Complete Response Rate|"Complete response requires that all of the following be present for at least four weeks.~1. Peripheral Blood Counts: Neutrophil count >= 1.0 x 109/L, Platelet count >= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood.~2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines, <= 5% blasts.~3. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present."|assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry|all enrolled patients|||percentage of participants||95% Confidence Interval|Number
2834449|NCT00262873|Secondary|Average Number of Leukemia Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline bone marrow was only available on 5 participants|||number of colonies per 50000 cell plated||Standard Deviation|Mean
2834450|NCT00262873|Secondary|Average Number of Erthroid Burst Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|analysis was performed on only four participants|||number of colonies per 50000 cell plated||Standard Deviation|Mean
2834451|NCT00262873|Secondary|Average Number of Colony Forming Unit-granulocyte-macrophages in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline marrow samples were available only 5 participants|||number of colonies per 50000 cell plated||Standard Deviation|Mean
2834452|NCT00262873|Secondary|Average Percentage of Light Density Cells in Apoptosis|The CD34+ fraction of light density marrow obtained from patients at baseline and while receiving bortezomib were assessed through measurement of Annexin V (assay obtained form R&D Systems) and by flow cytometry analysis.|day 14|marrow samples were not available on all participants at baseline|||percentage of apoptotic cells||Standard Deviation|Mean
2834453|NCT00262873|Secondary|Vascular Endothelial Growth Factor (VEGF) Levels in Serum|VEGF levels were measured by ELISA (R&DSystems) in serum from participants exposed to bortezomib. Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial.|day 14|data was only available on 5 participants|||pg/ml||Standard Deviation|Mean
2834454|NCT00262873|Secondary|Interleukin 6 Levels in Serum|"interleukin-6 levels were measured by enzyme-linked immunosorbant assay ELISA in serum from participants exposed to bortezomib.~Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial."|day 14|data was only available on 5 participants|||pg/ml||Standard Deviation|Mean
2834455|NCT00262873|Primary|Number of Participants Who Experienced Cytopenias||21 Days/course for up to 12 courses|This data was not collected.||||||
2834456|NCT00262873|Primary|Number of Participants Who Experienced an Adverse Event||For 21 days/course for up to 12 courses|patients enrolled to receive study drug|||participants|||Number
2834457|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 2)|Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline and 1-2 weeks after cycle 2, day 11|Samples were not collected on one patient, so only 17 patients were analyzed.|||percentage of change in proteosome activ||Full Range|Median
2834458|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 1)|Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline to 2 hours|Samples were not collected on one patient, so only 17 patients were analyzed.|||Percentage of change in proteosome activ||Full Range|Median
2834459|NCT00262860|Primary|Response Rate After 2 Courses of Therapy|Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).|21 Days/course for up to 2 courses||||participants|||Number
2834460|NCT00262847|Secondary|Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)|Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.|At baseline, 9, 18, 36, 60, and 84 weeks|Number of valid QOL assessments do not total number of patients randomized in study.|||units on a scale||Standard Deviation|Least Squares Mean
2834461|NCT00262847|Secondary|Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Eligible and Evaluable patients|Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
2834462|NCT00262847|Secondary|Overall Survival|Median overall survival (OS)|From study entry to death or last contact, up to 6 years||||months||95% Confidence Interval|Median
2834463|NCT00262847|Primary|Progression-free Survival|Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).|From study entry until first disease progression, death or date of last contact, up to 6 years||||months||95% Confidence Interval|Median
2834464|NCT00262834|Secondary|Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment|To evaluate baseline and change in histone acetylation in polymononuclear cells in patients with primary breast cancer who received three days of SAHA 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment.|Baseline and after 3 day of Vorinostat|No data was collected for this outcome. We were not able to successfully dissolve the pellet in lysis buffer, and the samples were not subjected to histone acetylation analyses.||||||
2834465|NCT00262834|Secondary|Change in Tissue Histone Acetylation After 3 Days of Treatment|To evaluate change from baseline in tissue histone acetylation in patients with primary breast cancer who received three days of Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment. This is measured by Cumulative Methylation Index, which is reported as the sum of all %M for all genes. %M= (methylated copies divided by methylated + unmethylated copies) x 100.|Baseline and after 3 day of Vorinostat|25 matched samples were collected; however, only 19 were available for analysis as there were 6 cases that were not evaluable for Cumulative Methylation Index.|||Cumulative Methylation Index|||Number
2834466|NCT00262834|Primary|Change in Tissue Apoptosis After 3 Days of Treatment|Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups. Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).|Baseline and after 3 day of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for cleaved caspase-3 by IHC were available from 19 (71%) treated and from 12 (48%) controls.|||percentage of change|Evaluable tissue samples|Full Range|Mean
2834467|NCT00262834|Primary|Change in Tissue Proliferation After 3 Days of Treatment|Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups. Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.|After 3 days of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for Ki-67 by IHC were available from 22 (92%) treated and from 15 (60%) controls.|||percentage of change|Evaluable tissue samples|Full Range|Mean
2834468|NCT00262834|Primary|Number of Participants With Adverse Events|Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery. 17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.|After 3 days of vorinostat|Participants who received at least one dose of vorinostat.|||participants|||Number
2834469|NCT00262821|Secondary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.|All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported|All Treated Patients|||participants|||Number
2834470|NCT00262821|Secondary|Overall Survival|The observed length of life from entry into the study to death or date of last contact.|From study entry to death or last contact, up to 6 years|Eligible and evaluable patients|||percentage of patients alive|||Number
2834487|NCT00262522|Primary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48||Week 48|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.|||Percentage of Subjects|||Number
2834471|NCT00262821|Primary|Progression-free Survival - Percentage of Patients Alive and Progression Free|Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.|From study entry until first disease progression, death or date of last contact, up to 6 years|Eligible and evaluable patients|||percentage of patients|||Number
2834472|NCT00262743|Other Pre-specified|24 Month Treatment Free Survival Rate|Percentage of participants who were alive and treatment (for progressive CLL) free at 24 months. The 24 month treatment free survival, with 95% CI, was estimated using the Kaplan-Meier method.|24 months (from registration)|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||percentage of participants||95% Confidence Interval|Number
2834473|NCT00262743|Secondary|Number of Participants With a Confirmed Complete Response (CR)|A confirmed complete response is a CR which is reported on 2 consecutive cycles at least 4 weeks apart. CR is defined in Primary Outcome Measure #1.|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||participants|||Number
2834474|NCT00262743|Primary|Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart|Bio-R: A reduction in the absolute lymphocyte count (ALC) of more than 20% from the pretreatment level for at least 2 months or a >= 30% reduction in all palpable lymphadenopathy without meeting the NCIWG criteria for PR was required|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||participants|||Number
2834475|NCT00262743|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response.~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.|||participants|||Number
2834476|NCT00262730|Primary|Survival|survival time is defined from time of histological diagnosis to death occurrence.|30 months|all patients who were treated were analyzed (intent to treat)|||months||95% Confidence Interval|Mean
2834477|NCT00262639|Primary|Percent Days Abstinent|percent days abstinent during treatment|Weeks 1 to 6||||percent days||Standard Deviation|Mean
2834478|NCT00262639|Primary|Percent Subjects Completely Abstinent|percent of subjects completely abstinent during the six week medication study study|6 week trial||||percent of participants|||Number
2834479|NCT00262600|Secondary|Abnormal Liver Function Test|Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN|36 months|Safety set - all subjects who were randomized and received at least 1 dose of study drug|||participants|||Number
2834480|NCT00262600|Secondary|Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)|Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)]|||Number
2834481|NCT00262600|Secondary|Bleeding Events (Major and Minor)|"Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25~Major bleeds are adjudicated, whereas minor bleeds are investigator reported."|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
2834482|NCT00262600|Secondary|Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death|Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
2834483|NCT00262600|Secondary|Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death|Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
2834484|NCT00262600|Primary|Yearly Event Rate for Composite Endpoint of Stroke/SEE|Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.|||yearly event rate (percentage)|||Number
2834485|NCT00262522|Secondary|Mean Change From Baseline to Week 96 in CD4+ T Cell Counts||Week 96 (End of Study)|All randomized subjects who received at least 1 dose of study drug and who had CD4+ T cell counts available at both the Baseline Visit and Week 96.|||cells/microliter||Standard Error|Mean
2834486|NCT00262522|Secondary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96||Week 96 (End of Study)|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.|||Percentage of Subjects|||Number
2834489|NCT00262509|Primary|Time to Exit Building|Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.|30 minutes total, 15 minutes for each of two timed trials|Total number of participants completing study|||seconds|Participants|Standard Deviation|Mean
2834490|NCT00262314|Primary|Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses|Outcomes are presented separately above apart from adverse events which are presented in the adverse event section|up to 5 years|||||||
2834491|NCT00262314|Primary|Clinical Relapses (Annual Follow-Up Phase)|Number of clinical relapses reported during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||number of relapses|||Number
2834492|NCT00262314|Primary|Clinical Relapses (Treatment Phase)|Number of clinical relapses reported during the treatment phase of the trial|up to 36 months||||number of relapses|||Number
2834493|NCT00262314|Primary|Severe Neutropenia (Annual Follow-Up Phase)|Number of infections associated with severe neutropenia at onset during the annual follow-up phase|up to 5 years|participants with annual follow up data|||number of infections|||Number
2834494|NCT00262314|Primary|Severe Neutropenia (Treatment Phase)|Number of infections associated with severe neutropenia at onset during the treatment phase|up to 36 months||||number of infections|||Number
2834495|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase|up to 5 years|participants with annual follow up data|||participants|||Number
2834496|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase|up to 36 months||||participants|||Number
2834497|NCT00262314|Primary|Serious Infections (Annual Follow-Up Phase)|Number of serious infections during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||number of infections|||Number
2834498|NCT00262314|Primary|Serious Infections (Treatment Phase)|Number of serious infections during the treatment phase of the trial|up to 36 months||||number of infections|||Number
2834499|NCT00262314|Primary|Left Ventricular Ejection Fraction (Annual Follow-Up Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||participants|||Number
2834500|NCT00262314|Primary|Left Ventricular Ejection Fraction (Treatment Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial|up to 36 months||||participants|||Number
2834501|NCT00262314|Primary|Congestive Heart Failure (Annual Follow-Up Phase)|Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data|||participants|||Number
2834502|NCT00262314|Primary|Congestive Heart Failure (Treatment Phase)|Number of patients experiencing congestive heart failure during the treatment phase of the trial|up to 36 months||||participants|||Number
2834503|NCT00262301|Secondary|Time to Minimal Symptoms|"the time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment time-points were: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to minimal symptoms has been calculated by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of study drug administration."|||minutes||Full Range|Median
2834504|NCT00262301|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms has been assessed by using a patient-reported visual analogue scale (VAS) ranging from 0 mm (no symptoms at all) to 100 mm (extremely disabling). Time to beginning of relief of symptoms at the location that showed first VAS score decrease of at least 20 mm from baseline score (t= 0 min) to the next assessment time-point). Assessment time-points were taken on pre-scheduled time-points after drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to beginning of relief has been calculated as median time, by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."|||minutes||Full Range|Median
2834505|NCT00262223|Primary|PTSD Symptom Severity / Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).|Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up||||units on a scale||Standard Deviation|Mean
2834506|NCT00262223|Primary|Heavy Drinking Days/Week||Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up||||Days/Week||Standard Deviation|Mean
2834507|NCT00262119|Primary|Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years|The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.|2 years|Analysis was intention to treat therefore all randomized patients were considered in the analyses|||percentage of participants||95% Confidence Interval|Number
2834508|NCT00262119|Secondary|Frequency, Type, and Associated Cost of Health Care Utilization and Utility||2 years|||||||
2834509|NCT00262119|Secondary|Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients||2 years|||||||
2834523|NCT00262119|Secondary|Incidence of Cardiovascular Hospitalizations at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years|2 years|Analysis was intention to treat therefore all randomized patients were analysed|||percentage of participants||95% Confidence Interval|Number
2834524|NCT00262119|Secondary|Incidence of Permanent Atrial Fibrillation at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were analysed|||percentage of participants||95% Confidence Interval|Number
2834525|NCT00262119|Secondary|Death for All Causes at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2834526|NCT00262080|Other Pre-specified|Time to Significant Improvement in Overall Response Over Multiple Treatment Episodes|The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline (ie,immediately before treatment) using the following 5-category scale from significant improvement (Score = 100)to significant worsening (Score = -100)|4 hours post-dose (REPEAT-DOSING PART)|Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the interquartile range (IQR) was not reached by 4 hours for most episodes.|||participants|||Number
2834527|NCT00262080|Secondary|Time to Significant Improvement in Overall Response|"The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline. Patients were asked overall how are you feeling compared to how they felt before study drug. Answer options were a lot worse, a little worse, same, a little better or a lot better or resolved. Significant improvement was the first time that the patient responded to the assessment as a little better or resolved."|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated. Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the median time for placebo was not reached by 4 hours.|||participant|||Number
2834528|NCT00262080|Other Pre-specified|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose Over Multiple Treatment Episodes|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.|||units on a scale||Standard Deviation|Mean
2834529|NCT00262080|Other Pre-specified|Treatment Outcome Score at 4 Hours Post-Dose Over Multiple Treatment Episodes|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.|||units on a scale||Standard Deviation|Mean
2834530|NCT00262080|Other Pre-specified|Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART)|Patient-reported severity of symptom complexes at baseline, by symptom complex and treatment group. Patients were to have at least one symptom complex that was moderate or severe. Patients could present with multiple symptom complexes, some of which could be mild. Mild=noticeable but do not impact daily living activities; Moderate=treatment or intervention is highly desirable and activities of daily living are impacted; Severe=require treatment or intervention due to inability to perform activities of daily living. The results are for number of patients with symptom complexes including mild, moderate and severe, provided the patients have at least one symptom complex that was moderate or severe|Baseline||||participants|||Number
2834531|NCT00262080|Secondary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement (minimally important difference) was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same center were administered treatment opposite to their randomized treatment assignments. Data were analyzed based on their actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 0.0; worst possible score = 3.0.|||units on a scale||Standard Deviation|Mean
2834594|NCT00261846|Secondary|Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.|Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months|Safety population included all participants who receive at least one dose of study medication.|||participants|||Number
2834532|NCT00262080|Primary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same study center were administered treatment opposite to their randomized treatment assignment. Data were analyzed based on actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 100; worst possible score = -100.|||units on a scale||Standard Deviation|Mean
2834533|NCT00262067|Secondary|Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
2834534|NCT00262067|Secondary|1-year Survival|"1-year survival was defined as the percentage of patients who were alive 1 year after randomization.~The percentage of patients alive at 1 year was determined using Kaplan-Meier analyses and the 95% confidence intervals were computed using the Brookmeyer-Crowley method."|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Percentage of participants||95% Confidence Interval|Number
2834535|NCT00262067|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
2834536|NCT00262067|Secondary|Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from the first tumor assessment that led to a determination of an objective response to the time of disease progression or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline and who had an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2834537|NCT00262067|Secondary|Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2834538|NCT00262067|Primary|Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.|||Months||95% Confidence Interval|Median
2834539|NCT00262041|Secondary|Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination|Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|Day 1 to Day 7|Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data.|||Subjects|||Number
2834540|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.|12 months after vaccination|Analysis was done on PP population.|||Titers||95% Confidence Interval|Geometric Mean
2834595|NCT00261846|Secondary|Number of Participants With Change From Baseline in Findings of Chest X-ray|Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline.|Baseline, Week 8, and end of treatment|Safety population included all participants who received at lease one dose of study medication.|||participants|||Number
2834541|NCT00262041|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.|12 months after vaccination|Analysis was done on PP population.|||Percentages Of Subjects||95% Confidence Interval|Number
2834542|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.|1 month after vaccination|Analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2834543|NCT00262041|Primary|Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine|Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y|1 month after vaccination|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation.|||Percentages Of Subjects||95% Confidence Interval|Number
2834544|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1- Day 360 (Throughout the study)|Analysis was done on safety population.|||Subjects|||Number
2834545|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1- Day 360 (throughout the study)|Analysis was done on safety population.|||Subjects|||Number
2834546|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1 to 7 post vaccination|Analysis was done on safety population.|||Subjects|||Number
2834547|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1 to 7 post vaccination|Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.|||Subjects|||Number
2834548|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.|||Titer||95% Confidence Interval|Geometric Mean
2834549|NCT00262028|Secondary|Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.|||Subjects|||Number
2834550|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Titer||95% Confidence Interval|Geometric Mean
2834551|NCT00262028|Secondary|hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Titer||95% Confidence Interval|Geometric Mean
2834552|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2834553|NCT00262028|Secondary|Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine|Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2834554|NCT00262028|Secondary|Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).|||Percentages of subjects||95% Confidence Interval|Number
2834555|NCT00262028|Primary|Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.|||Subjects|||Number
2834556|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age|The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.|7 days after vaccination at 12 months of age|"Analysis was done on safety dataset n population."|||subjects|||Number
2834557|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-|Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.|7 days after each vaccination|"Analysis was done on safety dataset n population - subjects who received at least one study dose and had Post baseline safety data."|||subjects|||Number
2834558|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)|The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population after second vaccination."|||percentages of subjects||95% Confidence Interval|Number
2834559|NCT00262002|Secondary|ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B|To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||titers||95% Confidence Interval|Geometric Mean
2834560|NCT00262002|Secondary|Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
2834561|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine|The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.|at 12 months of age and 1 month after PS challenge|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
2834562|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine|The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
2834563|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
2834564|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
2834565|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
2834566|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
2834567|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||Titers||95% Confidence Interval|Geometric Mean
2834568|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
2834569|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.|The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
2834570|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine|The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
2834571|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||titers||95% Confidence Interval|Geometric Mean
2834572|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine|Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."|||percentages of subjects||95% Confidence Interval|Number
2834573|NCT00262002|Secondary|Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population"|||titers||95% Confidence Interval|Geometric Mean
2834574|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population."|||percentages of subjects||95% Confidence Interval|Number
2834575|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||titers||95% Confidence Interval|Geometric Mean
2834576|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
2834635|NCT00261833|Secondary|Percent Change in DLCO|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
2834577|NCT00262002|Primary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine|Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and at 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."|||percentages of subjects||95% Confidence Interval|Number
2834578|NCT00261950|Secondary|Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52||Baseline to week 52|Enrolled subjects with TRAP at week 52|||percent change||Standard Error|Mean
2834579|NCT00261950|Secondary|Percent Change From Baseline in Osteocalcin (OC) at Week 52||Baseline to week 52|Enrolled subjects with osteocalcin (OC) at week 52|||Percent change||Standard Error|Mean
2834580|NCT00261950|Secondary|Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter|"Eroded Perimeter/Bone Perimeter was calculated as Eroded Perimeter/Bone Perimeter * 100"|Baseline to week 52|Enrolled subjects with eroded perimeter/bone perimeter at week 52|||percentage of bone perimeter||Standard Error|Mean
2834581|NCT00261950|Secondary|Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area|Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)|Baseline to week 52|Enrolled subjects with Fibrosis Area/Tissue Area at week 52|||participants|||Number
2834582|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)|"Osteoclast Perimeter was calculated as Osteoclast Perimeter/Eroded Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoclast Perimeter at week 52|||percentage of eroded perimeter||Standard Error|Mean
2834583|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)|"Osteoblast Perimeter was calculated as Osteoblast Perimeter/Osteoid Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoblast Perimeter at week 52|||percentage of osteoid perimeter||Standard Error|Mean
2834584|NCT00261950|Primary|Change From Baseline to End of Study in Bone Formation Rate (BFR)||Baseline to week 52|Enrolled subjects with bone biopsy at week 52|||μm^2/mm^2/day||Standard Error|Mean
2834585|NCT00261950|Secondary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
2834586|NCT00261950|Secondary|Percent Change From Baseline in N - Telopeptide (NTx) at Week 52||Baseline to week 52|Enrolled subjects with NTx at week 52|||percent change||Standard Error|Mean
2834587|NCT00261950|Secondary|Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52||Baseline to week 52|Enrolled subjects with BALP at week 52|||percent change||Standard Error|Mean
2834588|NCT00261950|Secondary|Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
2834589|NCT00261950|Secondary|Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
2834590|NCT00261950|Secondary|Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP)|||percent change||Standard Error|Mean
2834591|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values|Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, SBP of <80 or >210 mmHg, DBP of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, Resp of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.|Post-therapy|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. PLEASE NOTE: Results were not applicable for Arms in Part 1 since all participants in Part 1 entered Part 2 and continued the study treatment.|||percentage of participants|||Number
2834592|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs|Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, respiratory rate (Resp) of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kilogram (kg).|Screening, Baseline, and end of treatment|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||percentage of participants|||Number
2834593|NCT00261846|Secondary|Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair >50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead.|Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter|Safety population included all participants who receive at least one dose of study medication.|||participants|||Number
2835726|NCT00249249|Secondary|TC:HDL-C Ratio|Ratio of mean total cholesterol to mean HDL-C at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||ratio||Standard Deviation|Mean
2834596|NCT00261846|Secondary|Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings|Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit|Safety population included all participants who receive at least one dose of study medication. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure.|||Percentage of participants|||Number
2834597|NCT00261846|Secondary|Percentage of Participants With Change From Baseline in Laboratory Tests Results|Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported.|Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter|Safety population included all participants who receive at least one dose of study medication.|||Percentage of Participants|||Number
2834598|NCT00261846|Secondary|Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)|"An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.~NA = not estimable."|Baseline up to follow-up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.|||days||Full Range|Median
2834599|NCT00261846|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to follow up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.|||percentage of participants|||Number
2834600|NCT00261846|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2|OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, <5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10^9/L > platelets > 20x10^9/L, absolute neutrophil count ≥0.5x10^9/L, <20% basophils in blood, no extramedullary involvement [including liver or spleen]), minor hematologic response (acute lymphoblastic leukemia [ALL] patients only, defined as <15% blasts in marrow & blood, <30% blasts + promyelocytes in marrow & blood, <20% basophils in peripheral blood & no extramedullary disease other than spleen & liver) or return to chronic phase (AP/BP participants, defined as <15% blasts in both peripheral blood &bone marrow, <30% blasts + promyelocytes in both peripheral blood & bone marrow, <20% basophils in both peripheral blood & bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion.|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 year|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.|||percentage of participants||95% Confidence Interval|Number
2834601|NCT00261846|Secondary|Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2|Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count ≥ 1.0×10^9/L , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed).|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.|||percentage of participants||95% Confidence Interval|Number
2834602|NCT00261846|Secondary|Overall Survival (OS) - Part 2|"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.~NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least 1 dose of study medication.|||Months||95% Confidence Interval|Median
2834603|NCT00261846|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) - Part 2|"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.~NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2834604|NCT00261846|Secondary|Progression Free Survival (PFS) - Part 2|"PFS was based on Kaplan-Meier method. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4.~NA = not estimable. One year = 12 months"|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least one dose of study medication.|||Months||95% Confidence Interval|Median
2834605|NCT00261846|Secondary|Cumulative Incidence of Progression/Death - Part 2|"The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray's method.~NA = not estimable. One year = 12 months."|Years 1, 2, 3, 4, and 5 (CP2L only)|All-treated population included all enrolled participants who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2834606|NCT00261846|Secondary|Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only.|Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment - responders only.|||weeks||95% Confidence Interval|Median
2834607|NCT00261846|Secondary|Duration of Complete Hematologic Response (CHR) - Part 2|"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7.~NA = not estimable."|From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Subgroup of participants from evaluable population who had confirmed CHR.|||weeks||95% Confidence Interval|Median
2834608|NCT00261846|Secondary|Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2|"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets ≥100×10^9/L & <450×10^9/L, <20% basophils in blood & no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only & applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L & ADV: Year 4). NA = not estimable.~NA = not estimable."|From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)|Subgroup of participants from evaluable population who had confirmed CHR.|||% estimate of maintaining response||95% Confidence Interval|Number
2834609|NCT00261846|Secondary|Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML for Responders Only - Part 2|"MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.~Time to response in weeks equals (=) (event date minus (-) first dose date plus (+) 1)divided (/)7, where the event date is the non-missing date of the first attained response for responders only."|Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 5|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.|||weeks||95% Confidence Interval|Median
2834610|NCT00261846|Secondary|Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2|MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7.|From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5|Subgroup of participants from evaluable population who had MCyR.|||% probability of retaining MCyR||95% Confidence Interval|Number
2834611|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2|CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.|Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.|||percentage of participants||95% Confidence Interval|Number
2834763|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement|||x10^9 c/L||Full Range|Median
2834612|NCT00261846|Secondary|Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1|"CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry.~NA = not estimable."|6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.|||percent change||Standard Deviation|Mean
2834613|NCT00261846|Secondary|Phosphorylation Inhibition of Crk Like (CrkL) Protein at Baseline - Part 1|CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the cluster of differentiation 3 (CD3+) (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using fluorescent activated cell sorter (FACS) flow cytometry.|0 (pre-dose) on Day 1 (Baseline)|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||mol/100 cells||Standard Deviation|Mean
2834614|NCT00261846|Secondary|Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1|bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth.|Baseline, Weeks 4, 8, 12, 24, 36, 48 and the end of the active treatment phase of Part 1 (Week 52)|Data was not summarized since inadequate data included the issue that molecular transcript analyses could not be performed, because of potential sample quality issues due to time required to transport the specimens from the few investigational sites to the central laboratory.||||||
2834615|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.|Weeks 12, 24, 36, 48 and the end of active treatment phase of Part 1 (Week 52)|Cytogenetic evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline cytogenetic assessment.|||percentage of participants||95% Confidence Interval|Number
2834616|NCT00261846|Primary|Percentage of Participants With MCyR at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2|CyR is based on the prevalence of Ph+ cells. Major cytogenetic response was categorized as either CCyR or partial CyR (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or less than (<) 1% positive cells from at least 200 cells analyzed from fluorescent in situ hybridization (FISH). PCyR was achieved when 1 to 35% Ph+ cells were present.|Week 24|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.|||percentage of participants||95% Confidence Interval|Number
2834617|NCT00261846|Primary|Accumulation Ratio (R)|R=accumulation ratio (AUCss on Day 15/AUC0-24 on Day 1)|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2834618|NCT00261846|Primary|Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearence over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||L/hr||Standard Deviation|Mean
2834619|NCT00261846|Primary|Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
2834620|NCT00261846|Primary|Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||hrs||Standard Deviation|Mean
2834621|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1|Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.|||hrs||Full Range|Median
2834766|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
2834622|NCT00261846|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1|Maximum plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2834623|NCT00261846|Primary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||liter||Standard Deviation|Mean
2834624|NCT00261846|Primary|Apparent Oral Clearance (CL/F) - Part 1|"Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.~NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||liter per hour (L/hr)||Standard Deviation|Mean
2834625|NCT00261846|Primary|Area Under the Concentration-Time Curve (AUC) - Part 1|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.~NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
2834626|NCT00261846|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1|AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.|||ng*hr/mL||Standard Deviation|Mean
2834627|NCT00261846|Primary|Plasma Decay Half-Life (t1/2) - Part 1|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.~NA = not estimable."|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.|||hrs||Standard Deviation|Mean
2834628|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.|||hours (hrs)||Full Range|Median
2834629|NCT00261846|Primary|Maximum Observed Plasma Concentration (Cmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2834630|NCT00261846|Primary|Maximum Tolerated Dose (MTD)|"MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).~NA = not estimable."|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication|||mg|||Number
2834631|NCT00261846|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2834632|NCT00261833|Other Pre-specified|Baseline Lung Density at Total Lung Capacity (TLC) and Forced Residual Capacity (FRC)||Baseline||||g/L||Standard Deviation|Mean
2834633|NCT00261833|Secondary|Severity of Pulmonary Exacerbations|"Defined as the number of participants requiring 1) antibiotic treatment for exacerbations, and 2) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.~Antibiotic treatment usage was reported by quarterly interval."|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||participants|||Number
2834634|NCT00261833|Secondary|Duration of Pulmonary Exacerbations Relative to Treatment Duration|Defined as the percentage of total treatment duration across participants for 1) exacerbations overall, 2) antibiotic treatment for exacerbations, and 3) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||percentage of total treatment duration||Standard Deviation|Mean
2834636|NCT00261833|Secondary|Percent Change in FEV1 Divided by Forced Vital Capacity|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
2834637|NCT00261833|Secondary|Percent Change in Percent Predicted FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
2834638|NCT00261833|Secondary|Frequency and Intensity of Adverse Events (AEs)|Number of participants with at least one AE, and the number of participants with mild, moderate or severe AEs. AE intensity was defined as mild (does not interfere with routine activities), moderate (interferes with routine activities), or severe (impossible to perform routine activities).|Over a 2-year period|All participants receiving at least 1 infusion of either Zemaira® or placebo.|||participants|||Number
2834639|NCT00261833|Secondary|Change in Patient-reported Symptoms|Patient-reported symptoms were measured using the symptoms score component of the St George's Respiratory Questionnaire (SGRQ). SGRQ scores range from 0 to 100, with higher scores indicating more limitations and negative values for change indicating improvement. Change from baseline to end of treatment (2 years) in SGRQ was analysed using an ANCOVA.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||units on a scale||Standard Error|Least Squares Mean
2834640|NCT00261833|Secondary|Change in Exercise Capacity|Exercise capacity was measured as distance walked, using the incremental shuttle walk test. Change from baseline to end of treatment (2 years) in exercise capacity was analysed using an analysis of covariance (ANCOVA).|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||metre||Standard Error|Least Squares Mean
2834641|NCT00261833|Secondary|Change in Lung Density|Change from baseline to Month 24 as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least 1 endpoint assessment available.|||g/L||Standard Error|Least Squares Mean
2834642|NCT00261833|Secondary|Time to First Pulmonary Exacerbation|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||Years||95% Confidence Interval|Median
2834643|NCT00261833|Secondary|Percent Change in FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.|||percent change||Standard Error|Least Squares Mean
2834644|NCT00261833|Secondary|Annual Rate of Pulmonary Exacerbations|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion. The annual rate was based on the total number of exacerbations and the total number of participant study days for all participants in the specified analysis population and adjusted to 365.25 days.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.|||exacerbations per participant year||95% Confidence Interval|Number
2834645|NCT00261833|Primary|Annual Rate of Change in Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in each treatment group.|Over a 2-year period|All randomized participants with at least 1 valid CT scan.|||g/L per year||Standard Error|Least Squares Mean
2834646|NCT00261716|Secondary|Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)|Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.|6, 12, and 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=25 analyzed at 6 months; total n= 16 analyzed at 12 months; total n = 17 analyzed at 18 months|||units on a scale||Standard Deviation|Mean
2834647|NCT00261716|Secondary|Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)|Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=26 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 17 analyzed at 18 months|||units on a scale||Standard Deviation|Mean
2834648|NCT00261716|Secondary|Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale|Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=23 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 16 analyzed at 18 months|||units on a scale||Standard Deviation|Mean
2834649|NCT00261716|Secondary|Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program|Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study|18 months of the study|Includes only participants who obtained at least one job and had at least 2 months left if they lost/left that job; 2 individuals in each condition held the same job for almost the whole program and thus could not contribute data here|||participants|||Number
2834650|NCT00261716|Primary|Average Number of Hours Worked Per Week For Those Who Worked|Average number of hours worked per week among participants who obtained a job|18 months of study|Only included hours worked for participants who obtained a job (n=19 in the entire study)|||hours/worked per week||Standard Deviation|Mean
2834651|NCT00261716|Primary|Average Number of Days Worked|Average number of total days each participant worked in the study|18 months of study||||days||Standard Deviation|Mean
2834652|NCT00261716|Primary|Obtained Employment|Number of participants who obtained a competitive job|18 months of study||||participants|||Number
2834653|NCT00261495|Primary|Equi-analgesic Dose at Steady State (ITT Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||mg per day||Standard Deviation|Mean
2834654|NCT00261495|Primary|Equi-analgesic Dose at Steady-state (PP Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)|||mg per day||Standard Deviation|Mean
2834655|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||mg per day||Standard Deviation|Mean
2834656|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)|||mg per day||Standard Deviation|Mean
2834657|NCT00261495|Secondary|Resource Utilization of Pain Management|Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Additional visits||Standard Deviation|Mean
2834658|NCT00261495|Secondary|Mode and Convenience of Drug Intake.|Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834659|NCT00261495|Secondary|Amount of add-on Pain Medication|Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.|24 weeks|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||mg||Standard Deviation|Mean
2834660|NCT00261495|Secondary|Number of Days With add-on Pain Medication|Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Days||Standard Deviation|Mean
2834661|NCT00261495|Secondary|Number of Drop-outs|Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.|baseline to week 24 (core); week 24 to week 52 (extension)|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834662|NCT00261495|Secondary|Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)|Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.|weeks 4 and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834663|NCT00261495|Secondary|Change in Dose of Study Treatment|Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834664|NCT00261495|Secondary|Clinical Global Assessment of Efficacy|Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834665|NCT00261495|Secondary|Change From Baseline in QoL at Week 52|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2842395|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12||||L||Standard Error|Mean
2834666|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834667|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834668|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834669|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 24"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834670|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834671|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834672|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834673|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834674|NCT00261495|Secondary|"Change From Baseline in QoL Bodily Pain at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834675|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834676|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834677|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834678|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 4"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834679|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834680|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834681|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834682|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834683|NCT00261495|Secondary|"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"|Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834684|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 24 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834685|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 4 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 4.|week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834686|NCT00261495|Secondary|"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"|"Change from baseline in subject diary mean pain score pain at its worst from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score pain at its worst."|baseline and weeks 4, 8, 12, 16, 20, and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834687|NCT00261495|Secondary|Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24|Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834688|NCT00261495|Secondary|Number of Subjects Indicating Optimal Sleep at Week 52|Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.|week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834689|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 52|Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834690|NCT00261495|Secondary|Number of Subjects Indicating That They Had Optimal Sleep at Week 24|Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2834691|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Quantity at Week 24|Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834692|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24|Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834693|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24|Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834694|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24|Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834695|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Snoring at Week 24|Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834696|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24|Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834697|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 24|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834698|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834699|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index I) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834700|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)|Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834701|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834702|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834764|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||percent of total white blood cell count||Full Range|Median
2834703|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834704|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834705|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834706|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834707|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834708|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834709|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834710|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834711|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834712|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834724|NCT00261495|Secondary|"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain right now (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834713|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834714|NCT00261495|Secondary|"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"|"Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834715|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24|Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834716|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834717|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834718|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834719|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4|Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834720|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834721|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834722|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its worst (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834723|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834725|NCT00261495|Secondary|Number of Subjects With Dose Escalation|Number of subjects with dose increase in study medication.|week 4 and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Subjects|||Number
2835891|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 6, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2834726|NCT00261495|Secondary|"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary morning mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834727|NCT00261495|Secondary|"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary evening mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834728|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 24|Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834729|NCT00261495|Primary|"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834730|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"|"Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)|||Units on a scale||Standard Deviation|Mean
2834731|NCT00261495|Primary|"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)|||Units on a scale||Standard Deviation|Mean
2834732|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities|ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with ECG evaluation|||Participants|||Number
2834733|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities|Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with laboratory evaluation|||Participants|||Number
2834734|NCT00261443|Secondary|Extension Phase: Adverse Events (AEs), by Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with AEs|||Participants|||Number
2834735|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities|Vital sign abnormalities considered by the investigator as clinically relevant.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample|||Participants|||Number
2834736|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase|Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of Participants Analyzed=Participants in Extension Phase Safety Sample; n=number of participants with evaluation|||Participants|||Number
2834760|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834737|NCT00261443|Secondary|Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample|||Participants|||Number
2834738|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
2834739|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point|||units on a scale||Standard Error|Mean
2834740|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point|||units on a scale||Standard Error|Mean
2834741|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
2834742|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
2834743|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point|||units on a scale||Standard Error|Mean
2834744|NCT00261443|Secondary|Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample|||participants|||Number
2834745|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834761|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834746|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834747|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834748|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834749|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834750|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||bpm||Full Range|Median
2834751|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.|Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834752|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
2834753|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
2834754|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
2834755|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
2834756|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||msecs||Full Range|Median
2834757|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample|||Participants|||Number
2834758|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement|||x 10^3 c/uL||Full Range|Median
2834759|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2835948|NCT00246376|Primary|Non-HDL-C|non-HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dl||Standard Error|Mean
2834767|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement|||proportion of 'normal function'||Full Range|Median
2834768|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement|||percentage of 'normal function'||Full Range|Median
2834769|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834770|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement|||percentage of total blood volume||Full Range|Median
2834771|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement|||g/dL||Full Range|Median
2834772|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834773|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample|The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||percent of total white blood cell count||Full Range|Median
2834774|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834775|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
2834776|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834777|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||mg/dL||Full Range|Median
2834778|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
2834779|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
2834780|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement|||U/L||Full Range|Median
2834781|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3|ULN=upper limit of normal; Hb=hemoglobin|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n=number of participants with measurement|||participants|||Number
2834782|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3||Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)|Phase 3 Safety Sample; n=number of participants with measurement at time point|||kg/m^2||Inter-Quartile Range|Median
2834783|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Loss During Phase 3|Relevant weight loss: >=7% decrease from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point|||Participants|||Number
2834784|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Gain During Phase 3|Relevant weight gain: >=7% increase from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point|||Participants|||Number
2834785|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Weight||Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)|Observed Cases Data Set, Week 52 LOCF; n= number of participants with value at time point|||kg||Standard Error|Mean
2834786|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||beats per minute||Full Range|Median
2834787|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
2834788|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
2834789|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||beats per minute ?||Full Range|Median
2834790|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
2834791|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF|||mm Hg||Full Range|Median
2834792|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)|||beats per minute (bpm)||Full Range|Median
2834793|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)|||mm Hg||Full Range|Median
2834794|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)|||mm Hg||Full Range|Median
2834795|NCT00261443|Secondary|Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n= number of participants with measurement|||Participants|||Number
2834796|NCT00261443|Secondary|Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; (n=number of participants in sample for each category)|||Participants|||Number
2834797|NCT00261443|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample|||Participants|||Number
2834798|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834799|NCT00261443|Secondary|Baseline in Barnes Akathisia Global Clinical Assessment|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834800|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834801|NCT00261443|Secondary|Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834802|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834803|NCT00261443|Secondary|Baseline Abnormal Involuntary Movement Scale (AIMS)|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline|Phase 2 Safety Sample, participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834804|NCT00261443|Secondary|Median Change From Baseline in Leukocytes at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^3 c/L||Full Range|Median
2834805|NCT00261443|Secondary|Median Baseline Leukocytes||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^3 c/L||Full Range|Median
2834806|NCT00261443|Secondary|Median Change From Baseline in Prolactin at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||ng/dL||Full Range|Median
2834807|NCT00261443|Secondary|Median Baseline Prolactin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||ng/dL||Full Range|Median
2834808|NCT00261443|Secondary|Median Change From Baseline in Platelet Count at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^9 c/L||Full Range|Median
2834809|NCT00261443|Secondary|Median Baseline Platelet Count||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||x10^9 c/L||Full Range|Median
2834810|NCT00261443|Secondary|Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||proportion of 'normal function'||Full Range|Median
2834811|NCT00261443|Secondary|Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of 'normal function'||Full Range|Median
2834812|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||proportion of 'normal function'||Full Range|Median
2834861|NCT00260962|Secondary|Obsessions|Obsessions subscale of the Yale-Brown Obsessive Compulsive Scale. Minimum score is 0 and maximum score is 20. Higher scores indicate higher levels of obsessions.|Pretreatment (Week 1) and Posttreatment (Week 13)||||units on a scale||Standard Deviation|Mean
2835729|NCT00249249|Primary|Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12||Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||percent change||Standard Deviation|Mean
2834813|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of 'normal function'||Full Range|Median
2834814|NCT00261443|Secondary|Median Change From Baseline in Hematocrit||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of total blood volume||Full Range|Median
2834815|NCT00261443|Secondary|Median Baseline Hematocrit||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||percentage of total blood volume||Full Range|Median
2834816|NCT00261443|Secondary|Median Change From Baseline in Hemoglobin||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point|||g/dL||Full Range|Median
2834817|NCT00261443|Secondary|Median Baseline Hemoglobin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point|||g/dL||Full Range|Median
2834818|NCT00261443|Secondary|Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||percent of total white blood cell count||Full Range|Median
2834819|NCT00261443|Secondary|Median Baseline Eosinophils (Relative) and Neutrophils (Relative)||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||percent of total white blood cell count||Full Range|Median
2834820|NCT00261443|Secondary|Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
2834821|NCT00261443|Secondary|Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
2834822|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||msecs||Full Range|Median
2834823|NCT00261443|Secondary|Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
2834824|NCT00261443|Secondary|Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||U/L||Full Range|Median
2834825|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.|||kg/m^2||Full Range|Median
2834826|NCT00261443|Secondary|Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.|||kg||Full Range|Median
2834827|NCT00261443|Secondary|Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||mmHg||Full Range|Median
2834828|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||beats per minute||Full Range|Median
2834829|NCT00261443|Secondary|Median Baseline and Change From Baseline in ECG Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.|||msecs||Full Range|Median
2834862|NCT00260962|Primary|Body Mass Index (BMI) (kg/m^2)|Body Mass Index (BMI) measured in kg/m^2 units. Measured at Baseline (week 2) and post-treatment (week 13).|Baseline (week 2) and post-treatment (week 13)|4 participants discontinued in placebo group and 2 did not have weight measurements at week 13. 2 participants discontinued in the olanzapine group|||kg/m^2||Standard Deviation|Mean
2842396|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6||||L||Standard Error|Mean
2834830|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2|ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point|||Participants|||Number
2834831|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
2834832|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
2834833|NCT00261443|Secondary|Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
2834834|NCT00261443|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample|||Participants|||Number
2834835|NCT00261443|Secondary|Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample|||Proportion of Participants|||Number
2834836|NCT00261443|Secondary|Number of Participants Maintaining Remission During Phase 3|Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Observed cases data set, Phase 3 Efficacy Sample|||participants|||Number
2834837|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
2834838|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834839|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
2834902|NCT00259740|Primary|Complete Response or Partial Response Based on M-Protein Assessments Only|Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab|||Participants|||Number
2834840|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834841|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
2834842|NCT00261443|Secondary|Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834843|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834844|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
2834845|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834846|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
2834847|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834848|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; N=number of participants evaluated at time point; 4 participants in the Week 4 placebo group were not evaluated.|||units on a scale||Standard Error|Mean
2834849|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point|||units on a scale||Standard Error|Mean
2834850|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3|"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)."|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; n=number of participants with measurement at time point|||units on a scale||Standard Error|Mean
2834851|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2|"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)."|Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; n=number of participants with measurement at given time point.|||units on a scale||Standard Error|Mean
2834852|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3|Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS > 16 and/or a MADRS > 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score > 16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point|||proportion of participants|||Number
2834853|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) >16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) >16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score >16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point|||proportion of participants|||Number
2834854|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|LOCF data set, phase 3 efficacy sample; n=number of participants evaluated at given time point|||units on a scale||Standard Error|Mean
2834855|NCT00261443|Primary|Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS > 16 and/or a MADRS > 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS > 16 and/or a MADRS > 16.|Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample; n=number of participants at risk at each time point|||proportion of participants|||Number
2834856|NCT00261040|Secondary|Estimated Blood Loss|Estimated blood loss during the operative procedure|Day of surgery||||Millilitres (mL)||Standard Deviation|Mean
2834857|NCT00261040|Secondary|Operating Time Duration|Duration of the surgical procedure|Day of Surgery||||minutes||Standard Deviation|Mean
2834858|NCT00261040|Secondary|Change in Timed Get-up-and-Go Test (TUG)|A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility.|3 months||||seconds||Standard Deviation|Mean
2834859|NCT00261040|Secondary|Harris Hip Score|"Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor."|24 months||||units on a scale||Standard Deviation|Mean
2834860|NCT00261040|Primary|Clinical Outcomes|Hospital length of stay|24 months||||Days||Standard Deviation|Mean
2834863|NCT00260832|Secondary|Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)|Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL.|Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)|The primary population for all efficacy analyses was the ITT population defined as all participant randomly allocated to a treatment arm.|||percentage of participants|||Number
2834864|NCT00260832|Primary|Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm.|||months||Full Range|Median
2834865|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)~Absolute neutrophil count > 500/ μL~Platelet count > 20,000/ μL~Reticulocyte count > 60,000/ μL~Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|12 months||||Participants|||Count of Participants
2834866|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)~Absolute neutrophil count > 500/ μL~Platelet count > 20,000/ μL~Reticulocyte count > 60,000/ μL~Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|6 months||||Participants|||Count of Participants
2834867|NCT00260689|Primary|Hematologic Response|"Hematologic response is defined as subjects having blood counts no longer meeting the standard (Camitta) criteria for severe pancytopenia in Severe Aplastic Anemia, equivalent to 2 of the following values obtained on 2 serial blood count measurements at least one week apart at landmark time points (3, 6 and 12 months)~Absolute neutrophil count > 500/ μL~Platelet count > 20,000/ μL~Reticulocyte count > 60,000/ μL~Improvement in counts that are dependent upon exogenously administered growth factors or transfusion will not be considered as fulfilling response criteria."|3 months||||Participants|||Count of Participants
2834868|NCT00260533|Primary|Clinical Global Impression (Change Version, Also Known as Improvement Version)|"This is a commonly used, clinician-rated measure of clinical improvement.~The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.~For purposes of analysis, subjects rated as (1) Very Much Improved or (2) Much Improved were considered responders."|10 weeks (end of study)||||participants|||Number
2834869|NCT00260429|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint|||||||
2834870|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint|||||||
2834871|NCT00260429|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint|||||||
2834872|NCT00260429|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint|||||||
2834873|NCT00260429|Secondary|Percent Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint|||||||
2834874|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint|||||||
2834875|NCT00260429|Primary|Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.~The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|30 days after the last injection||||% Joints|||Number
2834876|NCT00260208|Secondary|Mean Fibrosis Score|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. The mean score was equivalent to mean of IK at 1 and 2 years (evolution over time).|At 1and 2 years and its evolution over time|This outcome was not analyzed because of premature termination of study.|||units on a scale||Standard Deviation|Mean
2834903|NCT00259649|Primary|Change in Mean Headache Index Score Among Patients|Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy|baseline to approximately three months||||headache index score||Standard Error|Mean
2834877|NCT00260208|Secondary|Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. An increase of at least 1 stage demonstrated a worsening of the disease, i.e. the transition from one score to the next higher one.|Between 1 and 2 years|The outcome measure was not analyzed because of premature termination of study.|||Percentage of participants|||Number
2834878|NCT00260208|Secondary|Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant|HCV RNA was measured (IU/µL)centrally pre-transplant (Day 1) and at 48 hours (Day 3), Day 8 and 29, Month 6 and 12 post-transplant and concomitantly to any additional biopsies performed.|Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n in each of the categories is the number of participants with data at the given time point."|||IU/µL||Standard Deviation|Mean
2834879|NCT00260208|Secondary|Mean Value of Liver Function Tests at 1 Year Post-transplantation|"The mean value (in Units per liter, IU/L) of following tests were calculated at 1 year post-transplant:~Serum glutamic pyruvic transaminase (SGPT)~Serum Glutamic Oxaloacetic Transaminase (SGOT)~Bilirubin~Alkaline Phosphate~γ-Glutamyltransferase (GGT)"|1 year post-transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n is number participants with assessable data in each category."|||IU/L||Standard Deviation|Mean
2834880|NCT00260208|Secondary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|The Intent-To-Treat (ITT) population consisted of all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2834881|NCT00260208|Secondary|Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis|Cirrhosis was resulted due to the recurrence of the hepatitis C virus infection in the transplanted liver.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2834882|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)|BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2834883|NCT00260208|Secondary|Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection|Treated acute rejection is defined as an acute rejection, clinically suspected, whether biopsy-proven or not, which has been treated and confirmed by the investigator according to the response to therapy. BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. A sub-clinical rejection was defined as a rejection identified by center driven biopsy, i.e. a biopsy performed routinely at some pre-defined time points after transplantation as per center practice in the absence of any clinical signs of rejection.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2834884|NCT00260208|Secondary|Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation|Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2834885|NCT00260208|Secondary|Number of Participants With Fibrosing Cholestatic Hepatitis|Fibrosing cholestatic hepatitis (FCH) is characterized by progressive jaundice with a rapid decline in liver function leading to liver failure, most often associated with markedly elevated viral levels detected in the bloodstream (e.g. more than 20 times pre-liver transplantation levels) and in the liver tissue as well. The presence of FCH was reported based on the diagnosis given by the investigator.|1 year post-transplantation|Intent-to-treat population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2834886|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2|The number of participants with combined end point of death or graft loss or presented with a Ishak-Knodell fibrosis score (FS) ≥2 was calculated. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had liver retransplant or died. Assessment of hepatic fibrosis was performed with liver biopsies read centrally. Ishak-Knodell FS was used to stage liver disease; 0=none; 1=portal fibrosis (some); 2=portal fibrosis (most); 3=bridging fibrosis (few); 4=bridging fibrosis (many); 5=Incomplete cirrhosis; 6=cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.|||Participants|||Number
2835067|NCT00257660|Secondary|Number of Participants Considered by the Investigator to be Overall Treatment Successes|The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.|Week 12|Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.|||participants|||Number
2834887|NCT00260208|Primary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. Logistic regression on the presence of IK>=2 was applied based on central biopsy readings only.|1 year post-transplant|The modified intent-to-treat population (mITT) included patients treated with study drug at least up to 30 days before Month 12 visit and a liver biopsy had to be performed at this visit. Also included were patients with an earlier biopsy that showed an Ishak-Knodell fibrosis score ≥2 and treated at least up to 30 days before that biopsy was taken.|||Participants|||Number
2834888|NCT00260195|Primary|Teacher Report of Behavior Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicates more problems, with total problem area scores ranging from 0 to 40.|Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
2834889|NCT00260195|Primary|Parent Report of Behavioral Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicate more problems, with total scores for problem areas ranging from 0 to 40.|Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
2834890|NCT00260195|Primary|Depressive Symptoms|Children's Depression Inventory (CDI; Kovacs, 1981) This 27-item measure assesses children's cognitive, affective, and behavioral depressive symptoms. The scale has high internal consistency, moderate test-retest reliability, and correlates in the expected direction with measures of related constructs (e.g., self-esteem, negative attributions, and hopelessness; Kendall, Cantwell, & Kazdin, 1989). Normative data are available (Finch, Saylor, & Edwards, 1985). We used a 26-item version of the scale that omits an item about suicidal ideation. Higher scores indicate more symptoms, and total scores can range from 0 to 52.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
2834891|NCT00260195|Primary|Post-traumatic Stress Disorder Symptoms|We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, & Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach's alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).||||units on a scale||Standard Deviation|Mean
2834892|NCT00260065|Secondary|Best Response and Overall Improvement|Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)|1 year|Intent-to-treat (ITT)|||Participants|||Number
2834893|NCT00260065|Primary|Number of Participants Who Achieved Overall Response|Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)|1 year|Intent-to-treat (ITT)|||participants|||Number
2834894|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of participants with fractures at the completion of therapy.|24 months|Number of participants with fractures at study completion.|||participants|||Number
2834895|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of Participants with Atraumatic fractures before therapy.|0 months|Number of participants with fractures before therapy.|||participants|||Number
2834896|NCT00259857|Secondary|Number of Participants With Improvement in BMD of Hip|Analysis was done per protocol and intention to treat.|24 months of therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
2834897|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.|24 months therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
2834898|NCT00259857|Secondary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy||12 months of therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
2834899|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.|12 months therapy|Analysis was done per protocol and intention to treat.|||participants|||Number
2834900|NCT00259740|Secondary|Complete Response Based on M-Protein Assessments Only|Complete response based on M-protein assessments, as defined for the primary outcome measure.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab|||Participants|||Number
2834901|NCT00259740|Secondary|Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only|Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab|||Participants|||Number
2834904|NCT00259610|Secondary|Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.|Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.|Year 2, Week 102|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.|||Scores on a scale||Standard Deviation|Mean
2834905|NCT00259610|Primary|Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)|"Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour.~The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity."|Change of the Mean of DAS28-ESR between weeks 48 - 102.|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.|||Scores on a scale||Standard Deviation|Mean
2834906|NCT00259298|Primary|Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).|baseline, 18 months|All participants with a baseline observation and at least 1 post-baseline observation.|||percentage of change of plasma clearance||Inter-Quartile Range|Median
2834907|NCT00259298|Secondary|Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton|Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.|baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||participants|||Number
2834908|NCT00259298|Secondary|Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton|Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||units on a scale||Standard Deviation|Mean
2834909|NCT00259298|Secondary|Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||percentage of change of skeletal uptake||Inter-Quartile Range|Median
2834910|NCT00259298|Secondary|Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.|||percentage of change of plasma clearance||Inter-Quartile Range|Median
2834911|NCT00259285|Secondary|Relapse-free Survival|Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.|Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter||||months||Standard Deviation|Mean
2834912|NCT00259285|Secondary|Pathologic Remissions After Surgery|The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.|surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)|7 out of the 10 patients had surgery.|||participants|||Number
2834913|NCT00259285|Primary|Treatment Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 21 day cycle (3 cycles) and 3-4 weeks after last cycle||||participants|||Number
2835949|NCT00246376|Secondary|Body Composition|"Body cell mass (kg)~Fat mass (kg)"|Measured at 24 weeks|The number corresponds to the number of subjects who completed the study (see Participant flow)|||kg||Standard Error|Mean
2834914|NCT00259272|Primary|Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix|This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.|Baseline|Matrix based on data from all 141 participants.|||value|||Number
2834915|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink|To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||microvolts||Standard Deviation|Mean
2834916|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink|To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||seconds||Standard Deviation|Mean
2834917|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Skin Conductance|To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||microvolts||Standard Deviation|Mean
2834918|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Heart Rate|to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.|||beats per minute||Standard Deviation|Mean
2834919|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834920|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834921|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834922|NCT00259272|Secondary|MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment|A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834923|NCT00259272|Secondary|Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)||24 weeks|Subgroup of patients who gained more than 7% of body weight.|||participants|||Number
2834924|NCT00259272|Secondary|Weight Gain Compared to Baseline|Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline|over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.|||participants|||Number
2834925|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Weight||Baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.|||kilograms||Standard Deviation|Mean
2834926|NCT00259272|Secondary|Increases and Decreases in Lipid Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.|||participants|||Number
2834927|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Lipids|Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).|Baseline and 24 Weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.|||milligrams per deciliter||Standard Deviation|Mean
2834928|NCT00259272|Secondary|Increases and Decreases in Fasting Glucose Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.|||participants|||Number
2834929|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)||baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.|||milligrams per deciliter||Standard Deviation|Mean
2835221|NCT00256451|Secondary|Profile of Mood States - Fatigue Scale|"Change from baseline to peak of the degree of fatigue experienced after alcohol ingestion~Profile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome"|During the challenge session||||units on a scale||Standard Deviation|Mean
2834930|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834931|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834932|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834933|NCT00259272|Primary|Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score|A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline, 6 Weeks, 24 weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.|||units on a scale||Standard Deviation|Mean
2834934|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.|For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)||||Percentage change from baseline||Standard Error|Mean
2834935|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.|For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|nine patients with PgR=0 at baseline were excluded from analysis of PgR because the question of medical interest was the effect of treatment on PgR positive patients.|||Percentage change from baseline||Standard Error|Mean
2834936|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.|For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)||||Percentage change from baseline||Standard Error|Mean
2834937|NCT00259012|Primary|Normalized Area of Esophageal Hydrogen Ion Activity Over Time|Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||H*mmol/L||Standard Deviation|Mean
2834938|NCT00259012|Primary|Normalized Area of Gastric Hydrogen Ion Activity Over Time|Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||H*mmol/L||Standard Deviation|Mean
2834939|NCT00259012|Primary|Percentage of Time That Intraesophageal pH Was <4|Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||percentage of time||Standard Deviation|Mean
2834940|NCT00259012|Primary|Median Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
2842397|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6||||L||Standard Error|Mean
2834941|NCT00259012|Primary|Mean Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
2834942|NCT00259012|Primary|Percentage of Time Intragastric pH Was >4|Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||percentage of time||Standard Deviation|Mean
2834943|NCT00259012|Primary|Median Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
2834944|NCT00259012|Primary|Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.|||units on scale||Standard Deviation|Mean
2834945|NCT00259012|Primary|Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration|Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.|7 days|All patients for whom at least 2 PK samples were obtained after 5 consecutive doses. Low dose population was 19 for both 2 and 4 hours. High dose population was 17 and 18 for 2 and 4 hours respectively.|||ng/mL||Standard Deviation|Mean
2834946|NCT00259012|Primary|Apparent Oral Clearance (CL/F)|Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||L/hr/kg||Standard Deviation|Mean
2834947|NCT00259012|Primary|Area Under the Concentration-time Curve (AUC)|Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||ng*hr/mL||Standard Deviation|Mean
2834948|NCT00259012|Primary|Disposition Half-life|Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||hr||Standard Deviation|Mean
2834949|NCT00259012|Primary|Time to Peak Concentration (Tmax) Profile|Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||hr||Full Range|Median
2834950|NCT00259012|Primary|Peak Concentration (Cmax)|Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.|||ng/mL||Standard Deviation|Mean
2834951|NCT00258960|Secondary|Overall Survival (OS)|OS was defined as the time elapsed from first treatment until death from any cause.|Through study treatment, and follow up period, assessed up to 88 weeks|49 patients included but 1 is not considered due to not receive any treatment and died before start|||Months||95% Confidence Interval|Median
2834952|NCT00258960|Secondary|Response Duration|Response duration was defined as the time elapsed from the first evidence of tumor response (Complete response or Partial Response) until clinical evidence of disease progression or death occurred.|Through study treatment, and follow up period, assessed up to 88 weeks|Patients with Overall Response (see ORR objective)|||Months||95% Confidence Interval|Median
2834953|NCT00258960|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time elapsed from first treatment until patient discontinuation due to toxicity, disease progression, death or withdrawal of consent for any reason, whichever occurred first.|Through study treatment, and follow up period, assessed up to 88 weeks|49 patients included but 1 is not considered due to not receive any treatment and died before start|||Months||95% Confidence Interval|Median
2834976|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1|Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.|0 to 3 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.|||Participants|||Number
2834954|NCT00258960|Secondary|Time to Progression (TTP)|TTP was defined as the time elapsed from first treatment until clinical evidence of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Through study treatment, and follow up period, assessed up to 88 weeks|49 patients included but 1 is not considered due to not receive any treatment and died before start|||Months||95% Confidence Interval|Median
2834955|NCT00258960|Primary|Objective Response Rate (ORR)|ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.|Up to cycle 6 (24 weeks)|49 patients included but 1 is not considered due to not receive any treatment and died before start|||Participants|||Count of Participants
2834956|NCT00258908|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination|The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose|Within 8 days of vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.|||Percentage of Participants|||Number
2834957|NCT00258908|Primary|Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination|GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
2834958|NCT00258908|Primary|Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination|Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 Post-vaccination|Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population|||Percentage of participants|||Number
2834959|NCT00258895|Primary|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination||Day 0 and between Days 28-48 post-dose 5|GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.|||All units||95% Confidence Interval|Geometric Mean
2834960|NCT00258895|Primary|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.||Day 0 and between Days 28-48 Post-dose 5|Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2834961|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination|Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.|Day 28 to 48 Post-Dose 5|The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
2834962|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination|Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.|Day 28 to 48 Post-dose 5|The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.|||Percentage of Participants|||Number
2834963|NCT00258895|Primary|Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination||0 to 7 days Post-Dose 5|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Percentage of Participants|||Number
2834964|NCT00258882|Primary|Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.|||Infants|||Number
2834965|NCT00258882|Primary|Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.|||Participants|||Number
2834966|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.|Days 0 to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events per 1000 Person-months|||Number
2834967|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events Per 1000 Person-months|||Number
2834968|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.~Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study."|Days 0 up to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events Per 1000 Person-months|||Number
2834969|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.~Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination."|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.|||Events Per 1000 Person-months|||Number
2834970|NCT00258856|Primary|Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.~Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination."|7 or 14 days post-vaccination|Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Percentage of participants|||Number
2834971|NCT00258830|Other Pre-specified|Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination|Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the per-protocol population.|||Percentage of participants|||Number
2834972|NCT00258830|Other Pre-specified|Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.|Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.|21 Days post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of participants|||Number
2834973|NCT00258830|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination|GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)|21 days post-vaccination|GMT results were assessed on the per-protocol population.|||Titer||95% Confidence Interval|Geometric Mean
2834974|NCT00258830|Primary|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination||Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data.|||Participants|||Number
2834975|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2|"Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting~Note: Influenza vaccine-primed group received only dose 1"|0 to 3 days post-vaccination 2|Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.|||Participants|||Number
2835008|NCT00258310|Primary|Feasibility of Treatment as Assessed.|Compliance was taking at least 80% of the prescribed dose for one year.|within 365 days||||percentage of participants||95% Confidence Interval|Number
2835009|NCT00258206|Secondary|Overall Survival||5 years|||||||
2834977|NCT00258817|Primary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination|"GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.~Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)"|Day 14 post-vaccination|Geometric Mean Titers were assessed on the per-protocol population.|||Titer||95% Confidence Interval|Geometric Mean
2834978|NCT00258674|Secondary|"Change Score for Semiannual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for a semi-annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834979|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834980|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834981|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834982|NCT00258674|Secondary|"Change Score for Annual Renal Function Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual renal function assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834983|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medical Record Review)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834984|NCT00258674|Secondary|"Change Score for Annual Foot Exam (as Determined by Medical Record Review)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual foot exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom baseline or follow-up records were not available were excluded.|||units on a scale||Standard Deviation|Mean
2834985|NCT00258674|Secondary|"Change Score for Annual Blood Pressure Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual blood pressure assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.|||units on a scale||Standard Deviation|Mean
2834986|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.|||units on a scale||Standard Deviation|Mean
2834987|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were missing for either baseline or follow-up were excluded.|||units on a scale||Standard Deviation|Mean
2834988|NCT00258674|Secondary|"Change Score for Systolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.|||mmHg||Standard Deviation|Mean
2834989|NCT00258674|Secondary|"Change Score for LDL Level"|Change score was calculated by subtracting the follow-up LDL value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.|||mg/dL||Standard Deviation|Mean
2834990|NCT00258674|Secondary|"Change Score for Diastolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.|||mmHg||Standard Deviation|Mean
2834991|NCT00258674|Secondary|"Change Score for HbA1c Level"|Change score was calculated by subtracting the follow-up HbA1c value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up HbA1c value were excluded.|||change in percentage of glycosolated-Hb||Standard Deviation|Mean
2834992|NCT00258674|Primary|"Change Score for Blood Pressure (b.p.) <130/80 mmHg"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure <130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)|Patients missing either a baseline or follow-up blood pressure value were excluded.|||units on a scale||Standard Deviation|Mean
2834993|NCT00258674|Primary|"Change Score for LDL <100 mg/dL"|"Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL <100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm."|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.|||units on a scale||Standard Deviation|Mean
2834994|NCT00258674|Primary|"Change Score for HbA1c <9 Percent"|"Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c <9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm."|This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up values for HbA1c were excluded.|||units on a scale||Standard Deviation|Mean
2834995|NCT00258440|Secondary|Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.||On study, averaging 3 to 6 months.||||events|||Number
2834996|NCT00258440|Secondary|Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28||weeks 4,8,16,24 and 28|||||||
2834997|NCT00258440|Secondary|Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.||every other week|||||||
2834998|NCT00258440|Primary|Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks||12 weeks|Due to low accrual numbers and the discontinuation of the study early a full analysis was not completed.|||participants|||Number
2834999|NCT00258362|Secondary|Percent of Patients Estimated to be Alive|This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.|1 Year, 2 Years, 3 Years|All 41 patients were included in this analysis.|||Percentage of Patients|||Number
2835000|NCT00258362|Primary|Percent of Patients Estimated to be Progression-Free and Alive|This estimate was determined by using a statistical method of analysis (Kaplan-Meier).|1 Year, 2 Years, 3 Years|Two patients with recurrent disease at study entry were excluded from this analysis.|||Percentage of Patients|||Number
2835001|NCT00258349|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients who were alive were censored as the last date of known alive.|Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|10 eligible HER2-positive (by central review) patients|||months||95% Confidence Interval|Median
2835002|NCT00258349|Secondary|Time to Progression|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Disease progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Time to progression is defined as time from registration to disease progression.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients|||months||95% Confidence Interval|Median
2835003|NCT00258349|Primary|Response Rate|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients|||percentage of participants||95% Confidence Interval|Number
2835004|NCT00258310|Secondary|Incidence of Second Primary Tumor Occurrence||Every 12 months|||||||
2835005|NCT00258310|Secondary|Survival Rate||from time of study entry until death|||||||
2835006|NCT00258310|Secondary|Local-regional Control Rate Occurrence||within 365 days|||||||
2835007|NCT00258310|Secondary|Time to Recurrence||assessed from time of study entry until documented|||||||
2835017|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835018|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835019|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835020|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835021|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835022|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835023|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835024|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835025|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835026|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835027|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835028|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||GMT||95% Confidence Interval|Geometric Mean
2835029|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
2835030|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
2835031|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
2835032|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
2835462|NCT00252512|Secondary|Legal Status|Number of participants reporting detention or incarceration in the previous 30 days|8 weeks, 6 month and 12 month follow ups|Lower numbers of participants returned for 6 and 12 month follow up assessments compared to 8 week follow up assessment.|||Participants|||Count of Participants
2835033|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Least Squares Mean
2835034|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis|||EU/mL||95% Confidence Interval|Geometric Mean
2835035|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation numbers|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835036|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation numbers)|||IU/mL||95% Confidence Interval|Geometric Mean
2835037|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation number)|||IU/mL||95% Confidence Interval|Geometric Mean
2835038|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation number)|||IU/mL||95% Confidence Interval|Geometric Mean
2835039|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835040|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835041|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after in a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835042|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Pre-dose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835043|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa , 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835044|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen|42 days after a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||ng/mL||95% Confidence Interval|Geometric Mean
2835045|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen|Day 1 of 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||ng/mL||95% Confidence Interval|Geometric Mean
2835463|NCT00252512|Secondary|Housing|Number of participants reporting stable housing (owned or rented house, apartment or room)|8 week, 6 month and 12 month follow-ups|Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week follow up assessment.|||Participants|||Count of Participants
2835046|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen|42 days after 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
2835047|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)|||Dilution Unit||95% Confidence Interval|Geometric Mean
2835048|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1|Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen|Day 1 of a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
2835049|NCT00258128|Secondary|Adiponectin||4 weeks||||mg/ml||Standard Deviation|Mean
2835050|NCT00258128|Primary|Glucose|fasting glucose|4 weeks|Receiving one dose of study drug and with measured value|||mmol/L||Standard Deviation|Mean
2835051|NCT00258011|Secondary|Urinary Glycosaminoglycan (GAG) Excretion|Percentage change in the concentration of GAG relative to creatinine in urine (ug GAG/mg creatinine) from baseline to last study visit. Greater decrease indicates greater response.|Up to 73 Weeks|"The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat. >~* 1 patient final visit = Week 73; 1 patient final visit = Week 32; 1 patient final visit = Week 10"|||percent change in concentration of GAG||Standard Deviation|Mean
2835052|NCT00258011|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|Up to 73 Weeks|The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat.|||participants|||Number
2835053|NCT00257933|Secondary|Rate of Relapse Between Treatment Groups||2 weeks after hospitalization|||||||
2835054|NCT00257933|Secondary|Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups||Every 4 hours during hospitalization|||||||
2835055|NCT00257933|Secondary|The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups||Every 4 hours during hospitalization|||||||
2835056|NCT00257933|Secondary|Time Spent in Each Severity Level of the Asthma Care Pathway||Time spent in each severity level of pathway|||||||
2835057|NCT00257933|Secondary|Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order||Mean time from writing admit order until discharge order|||||||
2835058|NCT00257933|Primary|Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered||Median time from loading dose to home dose of albuterol||||Hours||Inter-Quartile Range|Median
2835059|NCT00257920|Primary|Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|Per-Protocol Population - all subjects who completed both Period 1 and 2 and did not have major protocol violations.|||Fractions||Standard Error|Least Squares Mean
2835060|NCT00257920|Secondary|Calcium Absorption Fractions Analyzed by Mixed Model|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|ITT Population -all randomized subjects who received at least one dose of study drug and were analyzed by the randomized treatment sequence assigned to each subject.|||Fractions||Standard Error|Least Squares Mean
2835061|NCT00257894|Primary|Minnesota Nicotine Withdrawal Questionnaire|"Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal).~These data are only available on the subset of participants who participated through Day 10."|Day 10||||units on a scale||Standard Deviation|Mean
2835062|NCT00257894|Secondary|Cigarette Choice Task|"At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed).~These data are only available on the subset of participants who participated through Day 10."|Tenth day of medication titration||||choices||Standard Deviation|Mean
2835063|NCT00257894|Secondary|Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.|"Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse).~These data are only available on the subset of participants who participated through Day 10.."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.||||units on a scale||Standard Deviation|Mean
2835064|NCT00257894|Primary|Total Score on Questionnaire of Smoking Urges|"Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge).~These data are only available on the subset of participants who participated through Day 10."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.||||units on a scale||Standard Deviation|Mean
2835065|NCT00257686|Secondary|Percent Change From Baseline in TC|Percent change from baseline in total cholesterol (TC)|Baseline to 12 weeks||||Percent change||Standard Deviation|Mean
2835066|NCT00257686|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density cholesterol (LDL-C)|Baseline to 12 weeks||||Percent change||Standard Deviation|Mean
2835068|NCT00257660|Secondary|SF-36 Physical Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835069|NCT00257660|Secondary|SF-36 Mental Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835070|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.|||points on a scale||Standard Deviation|Mean
2835071|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.|||points on a scale||Standard Deviation|Mean
2835072|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.|||points on a scale||Standard Deviation|Mean
2835073|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).|Baseline and Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.|||points on a scale||Standard Deviation|Mean
2835074|NCT00257660|Secondary|Investigator VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835075|NCT00257660|Secondary|Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835076|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 12|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835077|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 8|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835093|NCT00257556|Secondary|Participants With Varying Numbers of Oocytes Retrieved|Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter.|Approximately study day 15|All treated patients population.|||participants|||Number
2835078|NCT00257660|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 4|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.|||points on a scale||Standard Deviation|Mean
2835079|NCT00257608|Secondary|Overall Survival|Overall survival was defined as the length of time from randomization to death.|Approximately 3.5 years|Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase.|||months||95% Confidence Interval|Median
2835080|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation|Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed.|||participants|||Number
2835081|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase|Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).|Approximately 3 years|Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed.|||participants|||Number
2835082|NCT00257608|Secondary|Number of Participants With Any Adverse Events During Post-Chemotherapy Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.|Approximately 3.5 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized.|||participants|||Number
2835083|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase|Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009.|Approximately 3 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed.|||participants|||Number
2835084|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase|Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.|Approximately 3 years|Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed.|||participants|||Number
2835085|NCT00257608|Primary|Progression-free Survival (PFS)|PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.|||months||95% Confidence Interval|Median
2835086|NCT00257556|Secondary|Mean Estradiol Level|Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.|Day 7 or 9 or 11 or 13|All patient treated population|||picomoles / liter||Standard Deviation|Mean
2835087|NCT00257556|Secondary|Mean Endometrial Thickness|Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.|Day 7 or 9 or 11 or 13|All patients treated population|||millimeters||Standard Deviation|Mean
2835088|NCT00257556|Secondary|Pregnancy Outcomes|Long term follow-up to determine the outcome of the pregnancy.|Approximately 10 months|All patients treated population|||participants|||Number
2835089|NCT00257556|Secondary|Mean Number of Days Stimulated With Gonadotrophins|Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.|study days 1 - 13|All patients treated population|||days||Standard Deviation|Mean
2835090|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Frozen|Number of participants with different categories of number of embryos frozen.|Approximately study day 17|All patients treated population|||participants|||Number
2835091|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Transferred|Number of participants with various categories of numbers of embryos transferred.|Approximately study day 17|All patients treated population|||participants|||Number
2835092|NCT00257556|Secondary|Participants With Varying Numbers of Pronuclear Stage Oocytes|Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.|Approximately study day 15|All patients treated population|||participants|||Number
2835094|NCT00257556|Secondary|Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters|The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.|Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)|All treated patients population|||participants|||Number
2835095|NCT00257556|Primary|Percentage of Participants With an Ongoing Pregnancy|Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.|Approx week 13; 9 weeks or more after the first positive pregnancy test|"All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as YES for ongoing pregnancy."|||percentage of participants|||Number
2835096|NCT00257556|Primary|Number of Participants With an Ongoing Pregnancy|Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.|Approx week 13; 9 weeks or more after the 1st positive pregnancy test|All patients treated population|||participants|||Number
2835097|NCT00257322|Primary|Participants Exhibiting Immune Response|Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.|24 Months||||Participants|||Count of Participants
2835098|NCT00257322|Secondary|Response Rates and Overall Survival.|Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.|24 Months||||Participants|||Count of Participants
2835099|NCT00257309|Primary|Death/Reinfarction/Disabling Stroke at 30 Days|Incidence of Death or Reinfarction or Disabling Stroke at 30 days|30 days||||Participants|||Count of Participants
2835100|NCT00257309|Primary|Incidence of Death or Reinfarction or Disabling Stroke|Incidence of all-cause death or myocardial reinfarction or disabling stroke|30 days||||participants|||Number
2835101|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||participants|||Number
2835102|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||participants|||Number
2835103|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||participants|||Number
2835104|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835113|NCT00257192|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Week 6, ET|ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835105|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835106|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835107|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).|||scores on a scale||Standard Deviation|Mean
2835108|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).|||scores on a scale||Standard Deviation|Mean
2835109|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 2, Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835110|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835111|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835112|NCT00257192|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835114|NCT00257192|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision."|Baseline, Week 2, Week 4, Week 6, Early termination (ET)|ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward [LOCF] imputation used for Week 6 LOCF timepoint.|||scores on a scale||Standard Deviation|Mean
2835115|NCT00257192|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Week 6|CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
2835116|NCT00257192|Secondary|Change From Baseline in PANSS: Positive and Negative Subscales at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
2835117|NCT00257192|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
2835118|NCT00257192|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6|CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
2835119|NCT00257192|Primary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Week 6|Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.|||scores on a scale||Standard Error|Least Squares Mean
2835120|NCT00257166|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 1, 2, 3, 4|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2835121|NCT00257166|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).|Baseline, Week 1, 2, 3, 4|ITT population. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2835122|NCT00257166|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 1, 2, 3|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were available for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
2835123|NCT00257166|Primary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 4|Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (>=) 1 dose of study medication (ziprasidone or placebo) and had >=1 post-baseline visit. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group.|||units on a scale||Standard Deviation|Mean
2835124|NCT00257010|Secondary|Number of Headaches With Vomiting|Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with vomiting|Participants||Number
2835125|NCT00257010|Secondary|Number of Headaches With Nausea|Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with nausea|Participants||Number
2835126|NCT00257010|Secondary|Number of Headaches With Phonophobia|Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with phonophobia|Participants||Number
2835127|NCT00257010|Secondary|Number of Headaches With Photophobia|Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches with photophobia|Participants||Number
2835128|NCT00257010|Secondary|Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose|Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches|Participants||Number
2835129|NCT00257010|Primary|Number of Pain Free Headaches at 2 and 24 Hours Post-Dose|Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.|||Number of headaches|Participants||Number
2835130|NCT00256997|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and End of Study (Month 24 or Early Termination [ET])|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Units on a scale||Standard Error|Mean
2835131|NCT00256997|Secondary|Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24|"AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the value of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)."|Baseline and Month 24|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Units on a scale||Standard Deviation|Mean
2835132|NCT00256997|Secondary|Number of Participants With Response to Resource Utilization Questionnaire (RUQ)|This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Participants|||Number
2835133|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Change (CGI-C)|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|End of Study (Month 24 or Early Withdrawal [EW])|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Participants|||Number
2835134|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and End of Study (Month 24 or Early Withdrawal [EW])|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||participants|||Number
2835135|NCT00256997|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Month 24|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Units on a scale||Standard Deviation|Mean
2835136|NCT00256997|Secondary|Time in Symptomatic (Having Symptoms) Remission|Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.|Baseline up to Month 24|Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan.||||||
2835137|NCT00256997|Secondary|Time to First Clinical Exacerbation|Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Months||Standard Error|Mean
2835138|NCT00256997|Secondary|Percentage of Participants Who Experienced a Clinical Exacerbation|Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Percentage of participants|||Number
2835139|NCT00256997|Primary|Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization|Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Month 3 up to Month 24|Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.|||Percentage of participants|||Number
2835140|NCT00256984|Secondary|SF-12 QOL Change (Mental Component) at 12 Months From Baseline|SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 months||||units on a scale||Standard Deviation|Mean
2835141|NCT00256984|Secondary|SF-12 QOL Change From Baseline (Physical Component)at 12 Months|The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 Months||||units on a scale||Standard Deviation|Mean
2835142|NCT00256984|Secondary|PAC QOL Patient Assessment of Constipation (Overall)|PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol|Baseline, 12 months|Sizing consistent with primary outcome; analysis was Intent-to-Treat|||units on a scale||Standard Deviation|Mean
2835143|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|Baseline, 6 months post procedure||||percentage of change||Standard Deviation|Mean
2835144|NCT00256984|Secondary|Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).|Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2835145|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure|Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 1 month post procedure||||percentage of change||Standard Deviation|Mean
2835146|NCT00256984|Primary|Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|one year from Baseline|Per protocol|||percentage of change||Standard Deviation|Mean
2835147|NCT00256867|Secondary|Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline|The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.|Up to Week 16|Safety population|||Participants|||Count of Participants
2835148|NCT00256867|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Week 16|Safety population.|||Participants|||Count of Participants
2835149|NCT00256867|Secondary|Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine|Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.|Up to Week 16|Safety population|||Participants|||Count of Participants
2835150|NCT00256867|Secondary|On-Therapy Change From Baseline in Body Weight|Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value.|Up to Week 16|Safety Population. Only those participants available at the specified time points were analyzed.|||Kilogram||Standard Deviation|Mean
2835151|NCT00256867|Secondary|On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to Week 16|Safety Population comprised of all participants who were randomized and received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835152|NCT00256867|Secondary|Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16|Number of participants achieving ADA target of FPG< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.|Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835153|NCT00256867|Secondary|Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16|Number of participants achieving ADA target of HbA1c < 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.|Up to Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835154|NCT00256867|Secondary|Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6|Number of participants achieving American Diabetes Association (ADA) target of LDL<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.|Week 6|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835155|NCT00256867|Secondary|Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)|Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.|Baseline (Week 0) and Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Millimol per litre (mmol/L)||Standard Deviation|Mean
2835950|NCT00246376|Secondary|Insulin Sensitivity|Adiponectin (micrograms/ml)|Measured at 24 weeks|All subjects who completed 24 weeks.|||micrograms/ml||Standard Error|Mean
2835156|NCT00256867|Secondary|Mean Change From Baseline to Week 16 in HbA1c|Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.|Baseline (Week 0) and Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||mg/dl||Standard Deviation|Mean
2835157|NCT00256867|Secondary|Median Percent Change From Baseline to Week 6 in LDL-c|Percent change from Baseline = 100*(exponent [change on log scale]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.|Baseline (Week 0) and Week 6|Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.|||Percent change in LDL-c||Full Range|Median
2835158|NCT00256867|Secondary|Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy|Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.|Baseline (Week 0) and Week 16|Intent-to-Treat with LOCF. Only those participants available at the specified time point were analyzed.|||mg/dL||Standard Deviation|Mean
2835159|NCT00256867|Primary|Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy|Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100*(exponent [change on log scale]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.|Baseline (Week 0) and Week 6|Intent-to-Treat Population comprised of all participants who were randomized and had at least one On-Therapy value for an efficacy assessment. The Intent-to-Treat population with last observation carried forward (LOCF) was used for efficacy analyses. Only those participants available at the specified time points were analyzed.|||Percent change in LDL-c||Full Range|Median
2835160|NCT00256854|Secondary|Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure|"Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the post evening dose values minus the pre evening dose values at the Week 1 visit and the changes for the second conversion were the post evening dose values minus the pre evening dose values at the Week 3 visit."|Up to 5 weeks|Conversion population. Only those participants available at the time of conversion were analyzed.|||mmHg||Standard Deviation|Mean
2835161|NCT00256854|Secondary|Change From Pre-conversion in Pulse Rate to One Week Post-conversion|"Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as Week 2 values minus the Week 1 values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the Week 4 values minus the Week 3 values."|Up to 5 weeks|Conversion Populations. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
2835162|NCT00256854|Secondary|Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion|"Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as Week 2 values minus the Week 1 values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the Week 4 values minus the Week 3 values."|Up to 5 weeks|Conversion Populations. Only those participants available at the indicated time points were analyzed.|||Millimeters of mercury (mm of Hg)||Standard Deviation|Mean
2835163|NCT00256854|Secondary|Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)|The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented.|Up to 5 weeks|Conversion populations. Only those participants at the indicated conversion were analyzed. The population from Cohort A1 and A2 are pooled to a single arm Cohort A. Similarly populations B1, B2 and C1, C2 are pooled to Cohort B and Cohort C, respectively.|||Participants|||Count of Participants
2835198|NCT00256750|Secondary|Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2|Months 6, 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/min/1.73 m^2||Standard Deviation|Mean
2835164|NCT00256854|Secondary|Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion|"The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the Week 1 total score from the Week 2 total score for the first conversion and the Week 3 total score from the Week 4 total score for the second conversion."|Up to 5 weeks|Conversion populations. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2835165|NCT00256854|Secondary|Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion|"Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1=Very much improved to 7=Very much worse). Typically, a participant with a score of 1 were considered as Very much improved and 2 as Much improved responder. Positive response was given in terms of worsen to stable or stable to improved."|Up to 4 weeks|First and Second Conversion Populations. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835166|NCT00256854|Secondary|Number of Participants With SAEs and Severity of AEs|SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported.|Up to 5 weeks|Conversion population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835167|NCT00256854|Secondary|Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS|AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 5 weeks|Conversion population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835168|NCT00256854|Primary|Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period|AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.|Up to 5 weeks|Conversion population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2835169|NCT00256750|Secondary|Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835170|NCT00256750|Secondary|Percent of Participants Surviving With a Functioning Graft|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Months 24, 36|All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N>=5. Otherwise exact method is used.|||percentage of participants||95% Confidence Interval|Number
2835222|NCT00256451|Secondary|Biphasic Alcohol Effects Scale - Sedation|"Change from baseline to peak of the amount of sedation post ingestion of alcohol~Biphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes"|During the challenge session||||units on a scale||Standard Deviation|Mean
2835951|NCT00246376|Primary|Triglycerides|Triglycerides (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dL||Standard Error|Mean
2835171|NCT00256750|Secondary|Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24, and 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Error|Mean
2835172|NCT00256750|Secondary|Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24,and 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Deviation|Mean
2835173|NCT00256750|Secondary|Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population.|||Ridit score||Standard Error|Mean
2835174|NCT00256750|Secondary|Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Deviation|Mean
2835175|NCT00256750|Secondary|Mean Value of Physical and Mental Components Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population|||units on a scale||Standard Deviation|Mean
2835176|NCT00256750|Secondary|Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36|Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||participants|||Number
2842398|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1||||L||Standard Error|Mean
2835177|NCT00256750|Secondary|Percent of Participants With Subclinical Rejection at Month 12|Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835178|NCT00256750|Secondary|Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12|Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine [SCr] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12|||participants|||Number
2835179|NCT00256750|Secondary|Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36|Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants|||Number
2835180|NCT00256750|Secondary|Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36|The use of LDT (thymoglobulin or antithymocyte gamma globulin [ATGAM]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants|||Number
2835181|NCT00256750|Secondary|Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12|A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met >= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output < 250 mL/12 hours, no significant improvement (< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.|Randomization to Month 12|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835182|NCT00256750|Secondary|Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||participants|||Number
2835252|NCT00255970|Primary|Change in Probing Depth|This is the distance, measured in millimeters (mm) from the gingival margin to the maximal penetration of the probe tip. The measures were made at baseline and then at 6 months after treatment.|baseline and then at 6 months||||mm||Standard Deviation|Mean
2835183|NCT00256750|Secondary|Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36|Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835184|NCT00256750|Secondary|Mean Value of Lipid Parameters|Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).|Months 12, 24, 36|All randomized and transplanted participants, intent-to-treat (ITT) population|||mg/dL||Standard Deviation|Mean
2835185|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hyperlipidemic Medication|This analysis is based on all participants who were followed up at least 1092 days after transplantation.|Month 36|All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.|||percentage of participants||95% Confidence Interval|Number
2835186|NCT00256750|Secondary|Number of Participants With Antihyperlipidemic Medication by Intensity Level|An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.|Month 36|All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.|||participants|||Number
2835187|NCT00256750|Secondary|Percent of Participants With Controlled Dyslipidemia at Month 12|Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized and transplanted participants, intent-to-treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835188|NCT00256750|Secondary|Percent of Participants With Prevalence of Dyslipidemia at Month 12|The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835189|NCT00256750|Secondary|Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12|Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835199|NCT00256750|Secondary|Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2836815|NCT00234286|Primary|Presence of Order for Opioid Pain Medication|Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
2835190|NCT00256750|Secondary|Percent of Participants With Prevalence of Controlled Hypertension at Month 12|The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835191|NCT00256750|Secondary|Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12|Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension|||percentage of participants||95% Confidence Interval|Number
2835192|NCT00256750|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Months 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mmHg||Standard Deviation|Mean
2835193|NCT00256750|Secondary|Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12|The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835194|NCT00256750|Secondary|Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12|The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835195|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36|This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP < 130 mm Hg and a DBP < 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835196|NCT00256750|Secondary|Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36|The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is >=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)|Week 4 post-transplantation to Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835197|NCT00256750|Secondary|Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m^2|Month 6 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/Min/1.73 m^2||Standard Deviation|Mean
2835219|NCT00256698|Secondary|Percentage of Evaluable Participants With Objective Response Rate (ORR)|No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||Percentage of evaluable participants|||Number
2835200|NCT00256750|Secondary|Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline|Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835201|NCT00256750|Secondary|Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Month 3 to Month 12; Month 3 to Month 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/min/1.73m^2||Standard Deviation|Mean
2835202|NCT00256750|Secondary|Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84|Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.|Randomization to Month 84|All randomized, transplanted, and treated participants; intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835203|NCT00256750|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36|"Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L).~Hemoglobin (low): <8.0 g/dL; Platelet count: <50*10^9 c/L; Leukocytes: <2*10^3 c/µL; Alkaline phosphatase (ALP): >5.0*ULN U/L; Alanine aminotransferase (ALT): >5.0*ULN U/L; Asparate aminotransferase (AST): >5.0*ULN U/L; Bilirubin Total: >3.0*ULN mg/dL; Creatinine: >3.0*ULN mg/dL; Calcium Total: low if <7.0 mg/dL or high if >12.5 mg/dL; Bicarbonate: <11.0 mEq/L; Potassium serum: low if <3.0 mEq/L or high if >6.0 mEq/L; Magnesium serum: low is <0.8 mEq/L or high if >2.46 mEq/L; Sodium serum: low if <130.0 mEq/L or high if >155.0 mEq/L; Phosphorus inorganic: <2.0 mg/dL; Albumin: <2 g/dL; Uric acid: >10 mg/dL; Protein urine: >=3+"|Baseline to Month 36|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population|||participants|||Number
2835204|NCT00256750|Secondary|Mean Blood Pressure at Month 84|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).|||mmHg||Standard Deviation|Mean
2835205|NCT00256750|Secondary|Number of Participants With Adverse Events of Special Interest by Month 84|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)|||participants|||Number
2835206|NCT00256750|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)|||participants|||Number
2835220|NCT00256698|Primary|Time to Progression (TTP)|"RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve respond, stay the same stableor worsen progression during treatments."|RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
2836895|NCT00232739|Secondary|Average Stent Obstruction Volume at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants with Stent Obstruction Volume data at 6 months post-procedure|||mm3||Standard Deviation|Mean
2835207|NCT00256750|Secondary|Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12|Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.|||percentage of participants||95% Confidence Interval|Number
2835208|NCT00256750|Secondary|Mean Value of the Measured Glomerular Filtration Rate (mGFR)|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Months 3, 12, 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||mL/min/1.73m^2||Standard Deviation|Mean
2835209|NCT00256750|Primary|Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835210|NCT00256750|Primary|Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.|Month 12; Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component|||percentage of participants||95% Confidence Interval|Number
2835211|NCT00256750|Primary|Percent of Participants Surviving With a Functioning Graft by Month 12|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2835212|NCT00256724|Secondary|Quantity of Fluid Administration||during 10 minutes of device use||||mL||Standard Deviation|Mean
2835213|NCT00256724|Primary|Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline||every 2 minutes during 10 minutes of device use||||mm Hg||Standard Deviation|Mean
2835214|NCT00256698|Secondary|Overall Survival (OS)|Overall survival is equivalent to time to death. Time from randomisation until the date of death|All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.||||months||Full Range|Median
2835215|NCT00256698|Secondary|Time to Treatment Failure (TTF)|Time from randomisation until the date of discontinuation of randomised treatment for any reason|From randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
2835216|NCT00256698|Secondary|Duration of Clinical Benefit (DoCB)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
2835217|NCT00256698|Secondary|Duration of Response (DoR)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||months||Full Range|Median
2835218|NCT00256698|Secondary|Percentage of Clinical Benefit Rate (CBR) Responders|No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009||||Percentage of participants|||Number
2835223|NCT00256451|Primary|Subjective High From Alcohol Scale|"Change from baseline to peak for the self reported feeling of being high after drinking~Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes"|during the alcohol ingestion||||units on a scale||Standard Deviation|Mean
2835224|NCT00256451|Primary|Profile of Mood States - Vigor|"Change from baseline to peak for the amount of Vigor experienced after alcohol ingestion~Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome"|during the challenge session||||units on a scale||Standard Deviation|Mean
2835225|NCT00256451|Primary|Biphasic Alcohol Effects Scale - Stimulation|"Change from baseline to peak for the feeling of stimulation after alcohol ingestion~Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome."|During challenge sessions||||units on a scale||Standard Deviation|Mean
2835226|NCT00256308|Secondary|Sites of Relapse|Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.|2 years|4 participants completed the study without any signs of disease. Only 1 participant had progressive disease but does not appear to be a relapse. No information provided to indicate whether other expired participant experienced a relapse.|||Participants|||Count of Participants
2835227|NCT00256308|Secondary|Overall Survival Rate|"Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.~From date of registration to date of death due to any cause"|2 years|4 participants completed follow up period. 2 participants expired in the follow up period. 1 due to progressive disease and 1 due to staph infection and secondary cause of death due to disease complications.|||Participants|||Count of Participants
2835228|NCT00256308|Secondary|Disease-free Survival Rate|"Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.~Progression-free survival: from date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration~Progression: Appearance of any new lesion/site. The site of the new lesion will be recorded. Death due to disease without prior documentation of progression and without symptomatic deterioration Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Efforts should be made to obtain objective evidence of progression after discontinuation"|2 years|4 participants completed survival follow-up. 1 patient had progressive disease and stopped study drug, discovered during follow-up that patient had expired in hospice care. 1 patient completed study treatment but expired in follow up due to staph infection and complications from disease in hospice care.|||Participants|||Count of Participants
2835229|NCT00256308|Secondary|Locoregional Control Rate|Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.|2 years|Study was terminated by funding source for slow accrual. Upon termination notification, all research procedures stopped, inclusive of completing any analysis of data collected. Specific information about collection of data could not be located.||||||
2835230|NCT00256308|Primary|Frequency and Severity of Toxicities|Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.|2 years|Although data were collected, events were not analyzed at the time of collection for relatedness to treatment and this analysis cannot be performed retrospectively due to lack of access to complete patient records.||||||
2835231|NCT00256295|Secondary|Overall Survival and Time to Treatment Failure||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.||||||
2835232|NCT00256295|Secondary|Frequency and Severity of Toxicities||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.||||||
2835233|NCT00256295|Primary|Overall Response Rate (Complete and Partial Response)|"Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline.~Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline."|5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.||||||
2835234|NCT00256282|Secondary|Percentage of Patients Alive at One Year||1 year||||Participants|||Count of Participants
2835235|NCT00256282|Primary|Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy|The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.|Six months from initial treatment||||days||95% Confidence Interval|Median
2835236|NCT00256243|Secondary|Microscopic Pathological Response Rate|pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.|||Participants|||Count of Participants
2835237|NCT00256243|Primary|Clinical Response Rate|Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.|||Participants|||Count of Participants
2835238|NCT00256204|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase|Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|36 weeks||||Scores on a scale||Standard Deviation|Mean
2835239|NCT00256204|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline|The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w||||Scores on a scale||Standard Deviation|Mean
2835240|NCT00256126|Secondary|Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Units per liter (U/L)||Standard Deviation|Mean
2835241|NCT00256126|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1|HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.|Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||picomole per liter *millimole per liter||Standard Deviation|Mean
2835242|NCT00256126|Secondary|Change From Baseline in Fasting Insulin Levels at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2835243|NCT00256126|Secondary|Change From Baseline in Fasting Glucose Levels at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2835244|NCT00256126|Secondary|Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1||Baseline, Month 1|The ITT population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||milligram per liter (mg/L)||Standard Deviation|Mean
2835245|NCT00256126|Primary|Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1|IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.|Baseline, Month 1|The Intention to Treat (ITT) population included all subjects who received at least 1 dose of study medication. Here “Overall Number of Subjects Analyzed” signifies those subjects who were evaluable for this outcome measure.|||Standard deviation score (SDS)||Standard Deviation|Mean
2835246|NCT00255970|Secondary|Mobility Index|"Tooth mobility was recorded using Miller's Index:~— up to 1 mm of movement in a horizontal direction~— greater than 1 mm of movement in a horizontal direction~— excessive horizontal movement and vertical movement. Manual evaluation of mobility was carried out clinically using the handles of two instruments to move the teeth buccally and lingually and note their movement."|6 months|A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study. The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|||Units on a scale||Standard Deviation|Mean
2835247|NCT00255970|Secondary|Bleeding on Probing|"The variable measured the presence of bleeding when the osseus defect was probed. The presence and character of gingival bleeding will be determined by gently probing to the base of the pockets.~0 - No bleeding.~1 - Bleeding when probing."|6 months|The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).|||Units on a scale||Standard Deviation|Mean
2835248|NCT00255970|Secondary|Plaque Index|"0- No plaque~A film of plaque adhering to gingival margin & adjacent area of tooth~Moderate accumulation of soft deposits, visible with the naked eye~Abundance of soft matter Each gingival region of the individual tooth will be scored 0-3 The scores from the 6 areas of the tooth are averaged to give the plaque index for the tooth."|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm|||Categorical index score||Standard Deviation|Mean
2835249|NCT00255970|Secondary|Gingival Index|"Scores:~0 Normal gingiva~Mild inflammation~Moderate inflammation~Severe inflammation Gingival units (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of each tooth were scored 0-3. Scores from the 6 areas of the tooth were added and divided by 6 to give the gingival index for the entire tooth."|6 months|As stated in the protocol, the power analysis (threshold=0.05, power>0.8) noted 18 subjects would be needed per group.|||Units on a scale||Standard Deviation|Mean
2835250|NCT00255970|Primary|Recession|CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm|||mm||Standard Deviation|Mean
2835251|NCT00255970|Primary|Clinical Attachment Level|The amount of space between attached periodontal tissues and a fixed point, usually the cementoenamel junction. A measurement used to assess the stability of attachment as part of a periodontal maintenance program.|6 months||||mm||Standard Deviation|Mean
2835253|NCT00255840|Primary|Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).|Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.|96 weeks|The primary analysis was an intention-to-treat analysis of any treatment failure with use of Cox proportional hazards regression.|||Percentage of participants||95% Confidence Interval|Number
2835254|NCT00255840|Secondary|To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site.||Throughout study|||||||
2835255|NCT00255840|Secondary|To Compare the Overall Clinical Safety of Antiretroviral Therapy, as Measured by the Occurrence of Clinical and Laboratory Grade 3 and 4 Adverse Events, Between Primary Health Care Monitoring Arms.||Throughout study|||||||
2835256|NCT00255840|Secondary|Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure||Throughout the study|||||||
2835257|NCT00255840|Secondary|To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.||Throughout study|||||||
2835258|NCT00255801|Secondary|Maximum Therapeutic Response|"CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT~CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.~CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.~Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease"|2 years||||Participants|||Count of Participants
2835259|NCT00255801|Primary|Median Progression-free Survival|"CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT~CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment.~CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome.~Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) [12, 13]; the Composite Assessment of Index Lesion Severity (CA) [9, 14] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease"|3 years||||months||Full Range|Median
2835260|NCT00255723|Primary|Overall Objective Response|"Overall objective response to therapy Complete remission/unconfirmed (CRu)~This includes patients who meet criteria for CR with the following exceptions:~1. A residual lymph node mass > 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR)~Any decrease in lymph nodes and nodal-based masses~Any decrease in PET avidity (however, residual FDG uptake is present)~Involving organs involved prior to therapy must have diminished in size.~No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease~1. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy"|3 years||||participants|||Number
2835261|NCT00255684|Secondary|Number of Participants Who Developed Acute Graft Versus Host Disease||3 months||||participants|||Number
2835262|NCT00255684|Primary|Number of Participants Who Survived 100 Days or Longer||100 days||||participants|||Number
2835263|NCT00255346|Secondary|Duration of Response (Survival)|Response date to loss of response or last follow up.|Baseline, once a week for a month, thereafter monthly, up to 10 years|The number of participants analyzed for duration of response reflects the number of participants with a response for each arm.|||Months||Full Range|Mean
2835264|NCT00255346|Primary|Participant Response Rate|"Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows:~Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase <20, and no organomegaly. PR is the improvement of C-Findings.~Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. PR is bone marrow blasts 6-25% but decreased by > 50% and absolute neutrophil count, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100.~Primary Myelofibrosis (PMF): CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. CR is PR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%.~HES/CEL: CR is disappearance of eosinophilia </= 10%, PR is reduction of eosinophilia by >/= 50%"|Baseline to completion of 4 week cycle or until disease progression||||Participants|||Count of Participants
2835265|NCT00255190|Primary|Changes From Baseline to Final Visit in Fundus Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing.|||subjects|||Number
2835266|NCT00255190|Primary|Changes From Baseline to Final Visit in Antrum Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing.|||subjects|||Number
2842399|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1||||L||Standard Error|Mean
2835267|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835268|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835269|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835270|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835271|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835272|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835273|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835274|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835275|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Pulse Rate||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||beats per minute||Standard Deviation|Mean
2835276|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Diastolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mm Hg||Standard Deviation|Mean
2835277|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Systolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mm Hg||Standard Deviation|Mean
2835278|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Serum Gastrin Levels||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||pg/mL||Standard Deviation|Mean
2835279|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||U/L||Standard Deviation|Mean
2835280|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||U/L||Standard Deviation|Mean
2835281|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||U/L||Standard Deviation|Mean
2835282|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Total Bilirubin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
2835283|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
2835284|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Calcium Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
2835285|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Creatinine Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
2835286|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||mg/dL||Standard Deviation|Mean
2835287|NCT00255190|Primary|Mean Change From Baseline to Month 12 for White Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||White Blood Cell count x10 to the 3/mcL||Standard Deviation|Mean
2835288|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Platelet Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||Platelet Count x10 to the 3/mcL||Standard Deviation|Mean
2835289|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||g/dL||Standard Deviation|Mean
2835290|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Red Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||Red Blood Cell count x10 to the 6/μL||Standard Deviation|Mean
2835291|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.|||score on a scale||Standard Deviation|Mean
2835292|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-QOL Total Score|Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses.|||score on a scale||Standard Deviation|Mean
2835293|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hematocrit Values|Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.|Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||percentage||Standard Deviation|Mean
2835294|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hemoglobin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.|||g/dL||Standard Deviation|Mean
2835295|NCT00255177|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 28|Mean log change in HCV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint|Baseline (Day 1) to Day 28||||copies/mL on log scale||Standard Deviation|Log Mean
2835296|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
2835297|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
2835298|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.|||Percentage of Subjects|||Number
2835313|NCT00255047|Primary|Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.||30 Days post-dose 3 vaccination.|Geometric mean titers were evaluated in the per-protocol immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
2835299|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
2835300|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
2835301|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.|||Percentage of Subjects|||Number
2835302|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
2835303|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
2835304|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.|||Percentage of Subjects|||Number
2835305|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Standard Deviation|Mean
2835306|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.|||Percentage of Days||Inter-Quartile Range|Median
2835307|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.|||Percentage of Subjects|||Number
2835308|NCT00255125|Secondary|Molecular Effects of Soy Supplementation Compared to Placebo.|Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.|One year|Data and project staff no longer available to determine results.||||||
2835309|NCT00255125|Secondary|Effect of Soy Isoflavones on Estrogen Receptor Status|Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.|Two weeks||||pg/mL||Standard Deviation|Mean
2835310|NCT00255125|Primary|Effect of Soy Isoflavones on Serum Testosterone Levels.|Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.|Two weeks||||ng/ml||80% Confidence Interval|Mean
2835311|NCT00255086|Secondary|Mean Change on the ADAS-Cog Score After 1 Year|Progression of cognitive functioning as measured by performance on the Alzheimer's Disease (AD) Assessment Scale-cognitive subscale (ADAS-Cog). ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics, and measures disturbances of of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Responses are summed for an overall score which can range from 0-70. The greater the dysfunction, the higher the score. A typical score for a person without dementia is 5.|Baseline; Year 1|Participants who could tolerate study medication and who completed the study were included in the analysis.|||units on a scale||Standard Deviation|Mean
2835312|NCT00255086|Primary|NAA/Cr Ratio|To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.|Baseline; Year 1|Participants who could tolerate study medication and who completed the study were included in the analysis.|||Ratio||Standard Deviation|Mean
2835314|NCT00255047|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3|Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.|7 days post-vaccination 3|Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population|||Participants|||Number
2835315|NCT00255047|Primary|Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)||30 Days post-dose 3 vaccination|Four-fold rise titers (seroconversion) were evaluated in the per-protocol population|||Percentage of participants|||Number
2835316|NCT00255047|Primary|Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.|Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.|30 Days post-dose 3 vaccination|The vaccine response to pertussis antigens were determined in the per-protocol population.|||Percentage of Participants|||Number
2835317|NCT00255034|Primary|Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy|No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.|24 weeks after completion of either up to 24 or 48 weeks of therapy|"Data were missing for 1 subject in the 48 weeks of therapy treatment arm."|||Participants|||Number
2835318|NCT00255008|Primary|Number of Subjects Who Achieved a Sustained Virologic Response (SVR)|SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.|24 weeks after completion of either up to 24 or 48 weeks of therapy|The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution. No data was available at 24 weeks after therapy for the Genotype 1 Caucasian treatment group.|||Participants|||Number
2835319|NCT00254995|Other Pre-specified|Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination|Only persons who received Menactra vaccine during the study period were included in this outcome.|Day 0 up to Determination of Pregnancy Outcome|Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.|||Paticipants|||Number
2835320|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
2835321|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only all persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
2835322|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2835323|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2835324|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2835367|NCT00254397|Secondary|Summary of Adverse Events by Grade/Relationship|Summary of adverse events( AE) collected during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grade 0-Sign/symptom within normal limits, Grade 1-Mild AE, Grade 2-Moderate AE, Grade 3-Severe AE, Grade 4- Life threatening or disabling AE.|Baseline up to 48 weeks during vaccine treatment||||occurences|||Number
2835325|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2835326|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2835327|NCT00254995|Primary|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
2835328|NCT00254982|Primary|Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score|PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).|Baseline and Week 22|Per Protocol Population - All participants in the intent to treat population who completed the study without major protocol violations. For missing data, the last observation carried forward (LOCF) was applied.|||Proportion of participants|||Number
2835329|NCT00254592|Primary|Overall Clinical Response to the Dose Dense Regimen|Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).|3 years||||Participants|||Count of Participants
2835330|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score|1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at TOC will be imputed by carrying forward the last post-baseline observation; Domain score is calculated by deriving the simple average of the relevant items, both mental state items must be non-missing to derive a mental state score|||Score on Scale||Standard Error|Least Squares Mean
2835331|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score|1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score|||Score on Scale||Standard Error|Least Squares Mean
2835332|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score|1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score|||Score on Scale||Standard Error|Least Squares Mean
2835333|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score|CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.|||Score on Scale||Standard Error|Least Squares Mean
2835464|NCT00252512|Secondary|VHA Healthcare Service Utilization|Cost of total healthcare utilization for six month period between baseline and 6 month follow up and six month period between 6 month and 12 month follow up.|Baseline to 6 month follow up and 6 month follow up to 12 month follow up.||||Dollars||Standard Deviation|Mean
2835334|NCT00254566|Secondary|Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence|Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.|Number of Days|Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.|||Days|||Number
2835335|NCT00254566|Secondary|Percentage of Bacteriologic Response at Test of Cure Visit|Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline|Test of Cure (TOC) Visit (Day 12-19)|Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.|||Percent|||Number
2835336|NCT00254566|Secondary|Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)|Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S&S, & a neg chest radiograph for pneumonia based on radiologist opinion|||Percent|||Number
2835337|NCT00254566|Secondary|Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)|Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.|||Percent|||Number
2835338|NCT00254566|Primary|Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)|Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.|||percent|||Number
2835339|NCT00254540|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.~n=Number of subjects with analyzable data."|||pg/mL||Full Range|Median
2835340|NCT00254540|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.~n=Number of subjects with analyzable data."|||pg/mL||Full Range|Median
2835341|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
2835342|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
2835343|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
2835344|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
2835746|NCT00248833|Primary|Safety: Severity Summary of Solicited and Unsolicited Adverse Events|Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination|7 day f/u period after each vaccination||||AEs|||Number
2835345|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3."|||ng/mL||Full Range|Median
2835346|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."|||ng/mL||Full Range|Median
2835347|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)|"Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline.~The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n=Number of subjects with analyzable data."|||Scores on a scale||Standard Deviation|Mean
2835348|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score|Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n=Number of subjects with analyzable data."|||Scores on a scale||Standard Deviation|Mean
2835349|NCT00254540|Secondary|Overall Survival Time|Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.|once year. Up to 3 years after the completion of subject registration.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||Full Range|Median
2835350|NCT00254540|Secondary|Time to Tumor Response (TTR)|Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.|||Weeks||Full Range|Median
2835351|NCT00254540|Secondary|Duration of Response (DR)|Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.|||Weeks||Full Range|Median
2835352|NCT00254540|Secondary|Time To Tumor Progression (TTP)|Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||Full Range|Median
2835353|NCT00254540|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||Weeks||Full Range|Median
2835354|NCT00254540|Primary|Number of Subjects With Objective Response|Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.|||participants|||Number
2835368|NCT00254397|Secondary|Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms|Maximum Grade reported for participant adverse events. collected study wide during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).|Baseline up to 48 weeks during vaccine treatment|Only 91 participants' data was available for classification in analysis.|||participants|||Number
2835747|NCT00248807|Secondary|Cerebral Blood Flow|Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt|acute testing||||cm/sec||Standard Deviation|Mean
2835355|NCT00254501|Secondary|Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months|"Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):~Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment~Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers.~Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent)."|From baseline to 12 months|The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys.|||units on a scale||95% Confidence Interval|Mean
2835356|NCT00254501|Secondary|Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months|"Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:~Total cost of care~Costs of diabetes medications~Costs of diabetes supplies"|baseline to 12 months|Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline.|||US dollars||95% Confidence Interval|Mean
2835357|NCT00254501|Secondary|Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides|"Changes from baseline in LDL, HDL, total cholesterol, triglycerides.~Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):~LDL~HDL~Total cholesterol~Triglycerides"|baseline and 12 months|The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.|||mg/dl||95% Confidence Interval|Mean
2835358|NCT00254501|Primary|Change in Hemoglobin A-1C From Baseline|Compare changes in Hemoglobin A-1C from baseline between the two groups.|baseline and 12 months|Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.|||percentage of glycolsylated hemoglobin||Standard Deviation|Mean
2835359|NCT00254488|Primary|Young Mania Rating Scale (YMRS) Scores|The Young Mania Rating Scale is an eleven item interviewer-rated instrument. Four items are scored 0-8, the others 0-4. The total score therefore ranges from 0-60, with higher values reflecting greater severity.|Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9|The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.|||units on a scale||Standard Deviation|Mean
2835360|NCT00254488|Primary|Sedation Score|The Sedation Item score of the UKU (Norwegian for Committee of Clinical Investigations) Side Effect Rating Scale. A higher value indicates greater severity. Range is 0-3 (not present, mild, moderate, or severe).|Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9|The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.|||units on a scale||Standard Deviation|Mean
2835361|NCT00254462|Secondary|Change in Total ADHD-IV Teacher|Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.|Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.||||units on a scale||Standard Error|Mean
2835362|NCT00254462|Primary|Change in ADHD-IV Rating Scale Total Score|"Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.~The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27."|Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.||||units on a scale||Standard Error|Mean
2835363|NCT00254410|Secondary|Molecular Response Rate at 6 Months|Molecular response rate (PCR for IgH rearrangements) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of 6 months|One participant showed progression while on therapy and was taken off study after 3 courses. Of the 30 participants who started therapy, one participant was not analyzed at the end of cycle 6.|||Participants|||Count of Participants
2835364|NCT00254410|Secondary|Molecular Response Rate at 3 Months|Molecular response rate (PCR for immunoglobulin heavy chain (IgH) rearrangements) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of cycle 3||||Participants|||Count of Participants
2835365|NCT00254410|Primary|Clinical Response Rate at 6 Months|Clinical Response Rate (combined morphological [NCI WG criteria] + flow cytometry criteria) at 6 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of Cycle 6|One participant showed progression while on therapy and was taken off study after 3 courses. Of the 30 participants who started therapy, one participant was not analyzed at the end of cycle 6.|||Participants|||Count of Participants
2835366|NCT00254410|Primary|Clinical Response Rate at 3 Months|Clinical Response Rate (combined morphological [NCI Working Group (WG) criteria] + flow cytometry criteria) at 3 months following treatment. Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.|End of cycle 3||||Participants|||Count of Participants
2835748|NCT00248807|Primary|Systolic Blood Pressure|Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention|acute testing|convenience sample|||mmHg||Standard Deviation|Mean
2835369|NCT00254397|Secondary|Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study|Summary of most frequent adverse events collected study wide during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).|Baseline up to 48 weeks during vaccine treatment|Although our immunologic analysis was based on participants HLA type in order to determine reactivity against particular peptides, all participants received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed participants within these two groups.|||occurences|||Number
2835370|NCT00254397|Primary|Number of Participants With T-cell Response to Peptide Vaccine|"Reactivity to the gp100 peptide in each participant defined as >10 tetramer positive cells per 10^4 CD8+ T-cells as determined by the tetramer analysis at 3 months following initial vaccine. Number of participants with response as defined reported.~The primary end point of this clinical study was the comparison of tumor-specific immune responses to melanoma-specific peptide vaccines, gp100 and MAGE-3 in the presence or absence of Leuprolide.~Gp209-2M/HLA-A*0201 tetramers that are commercially available employed to analyze levels of gp209-2M specific CD8+ cytolytic T cells. The levels of peptide/ HLA-A*0201 tetramer between participants' peripheral blood mononuclear cells (PBMCs) with Leuprolide injection and without Leuprolide injection compared."|At 3 months following initial vaccine.|Although all participants did not receive all doses of the vaccine due to tumor progression and other reasons, if samples were available after two or more vaccinations, analyses were performed.|||Participants|||Count of Participants
2835371|NCT00254293|Secondary|Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies|Assessment of positive antibody response based upon analysis using a validated enzyme-linked immunosorbent assay (ELISA) with a cut-off value. CTLA4 is a protein receptor that downregulates the immune system. Short Term (ST) period was initial 12 Weeks of the study. Overall LTE includes both the variable and fixed abatacept dosing periods and was from the end of the ST period (Day 85) up to 168 days post last dose (treatment in LTE ranged from 4.4 to 74.2 months. Data in the ST period are summarized by the treatment the participants actually received, while the LT period data are summarized by treatment the participant was randomized to receive.|ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dose|In the ST period, only subjects treated with abatacept (51) were evaluated for antibodies. In LTE, 61 participants were analyzed for anti-abatacept antibodies, and 62 participants were analyzed for CTLA4-T antibodies. Participants were analyzed during treatment and post-treatment (28, 56, 85, and 168 days post-treatment).|||participants|||Number
2835372|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)|On Day 85 participants rolled over into the LTE with variable dose phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight. This summary includes AEs reported during entire LTE treatment plus 56 days post last dose; includes all deaths reported during the LTE including those that occurred greater than 56 days after last dose. MedDRA version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 533 to 56 Days Post last dose|total number of participants in the Long Term Extension Period.|||participants|||Number
2835373|NCT00254293|Secondary|Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. Heart Rate was reported in beats per minute (bpm). In no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 65 had results at screening and 53 had results at Discharge (Day 85) for Heart Rate.|||bpm||Standard Deviation|Mean
2835374|NCT00254293|Primary|Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)|LTE period with variable abatacept dosing starting on Day 85 and continuing until Day 533 when LTE fixed dosing started. AEs of special interest: infection and/or infestation; neoplasms (malignant); pre-specified autoimmune disorder; infusional AEs (peri-infusional: pre-specified AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: pre-specified AEs occurring during the first hour after the start of the IV loading dose; systemic injection site reactions (SIR): pre-specified AEs for SIR; local injection site reaction: pre-specified AEs for local site reaction. Data are presented by treatment the participant was randomized to and not what they actually received.|Day 85 to Day 533|All 63 participants who completed the ST period enrolled into the LTE variable dosing period and were analyzed.|||participants|||Number
2835375|NCT00254293|Secondary|Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. QT interval, PR interval and QRW Width were reported in milliseconds (msec). If no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 66 had results at screening and 52 had results at Discharge (Day 85) for QT interval and QRS Width; 65 and 51 participants had PR interval results at Screening and Discharge (Day 85), respectively.|||msec||Standard Deviation|Mean
2835376|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Pulse rate was taken while participant was seated. Pulse rate was recorded during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, vital signs were recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Pulse rate measured in beats/min (bpm). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28, 6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively|||bpm||Standard Deviation|Mean
2835377|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Blood pressure (systolic and diastolic) was recorded while the participant was seated during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, blood pressure was recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Blood pressure was measured in millimeters of mercury (mm Hg). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28,6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively|||mm Hg||Standard Deviation|Mean
2835378|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85|Screening, BL, Days 15, 29, 57, 85 or discharge. Upper limit of normal (ULN). CTC grade (Gr): Alanine transaminase Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase Gr 1: >ULN to 2.5*ULN; Gr 2:>2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. G-Glutamyl Transferase (U/L) Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Alkaline phosphatase (U/L) Gr 1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4: >20.0*ULN; creatinine (mg/dL) Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 6.0*ULN; Gr 4: >10.0*ULN. Albumin (g/dL) Gr 1:<LLN to 3.0; Gr 2:<3.0 to 2.0; Gr 3: <2.0. Uric Acid (mg/dL)Gr 1: >1.0 x ULN to 10.0; Gr 4: >10.0. Sodium (mEq/L) Gr 1: >ULN to 150; Gr 2: >150 to 155; Gr 3: >155 to 160; Gr 4: > 160. Potassium (mEq/L) Gr 1: >ULN to 5.5; Gr 2: >5.5 to 6.0; Gr 3: >6.0 to 7.0; Gr 4: >7.0. Data presented by treatment participant actually received.|Day 1 to Day 85 (or early termination)|All participants treated with abatacept or placebo in the short term period. Participant is counted once in total but could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)|||participants|||Number
2835379|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)|Blood samples were obtained: At screening, within 24 hours prior to study drug administration on Day 1, on Days 15, 29, 57 and at study discharge. Baseline (BL) defined as Day 1 prior to treatment. Common toxicity criteria (CTC), Version 3 used to assess parameters. lower limit of normal (LLN). ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Lymphocytes Gr 1: <LLN to 3.0, Gr 2: 2.0 < 3.0, Gr 3: 1.0 to < 2.0, Gr 4; < 1.0. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Hematocrit (%): <0.75*pre-treatment. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants treated with either abatacept or placebo. Participant counted once in total for each arm but participant could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)|||participants|||Number
2835380|NCT00254293|Secondary|Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration|Serum samples were obtained on Days 1, 8, 15, 29, 57 and day of discharge (Day 85 or earlier) for determination of presence of rheumatoid factor (RF). Baseline was defined as Day 1 to calculate percent change. Lower limit of quantitation (LLQ) was 5 Units/milliliter (U/mL). Values below LLQ were set to 2.5 U/mL. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|Analysis set included all available data from participants who received abatacept or placebo. For RF analysis in Group 1 Day 1/Day 85 number of participants = 7/7; Group 2 = 3/3; Group 3 = 29/29; Group 4 = 6/6; Group 5 = 5/5; Placebo = 17/15 participants.|||percentage of change from baseline||Standard Deviation|Mean
2835381|NCT00254293|Secondary|Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks|AEs of special interest: infection and/or infestation; neoplasms (benign, malignant, unspecified; autoimmune disorder; infusional AEs (peri-infusional: AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: AEs occurring during the first hour after the start of the IV loading dose; injection site AEs: AEs occurring at the site of the SC injection. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All subjects treated were analyzed for safety.|||participants|||Number
2835409|NCT00253643|Primary|Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention|Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.|End of study|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.|||%age of cells & nuclei stained||Full Range|Median
2836896|NCT00232739|Secondary|Average Lumen Volume (mm3) at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants who had Lumen Volume data at 6 months post-procedure|||mm3||Standard Deviation|Mean
2835382|NCT00254293|Secondary|Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo|Number of Participants with Adverse events (AEs), Serious AEs, discontinuations due to AEs, or Deaths occurring while participant was on treatment from Day 1 (treatment) to Day 85 or early termination from the study. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)||||participants|||Number
2835383|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)|AEs during variable dose phase of LTE + 56 days post last dose in the variable dose phase or start of the fixed dose phase, which ever came first; includes deaths reported during the variable dose phase including those that occurred greater than 56 days after last dose. Medical Dictionary for Regulatory Activities (MedDRA) version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug. Data presented by treatment the participant was randomized to and not what they actually received.|Day 85 to 56 days post last dose|Participants included those that rolled over into the LTE, receiving variable SC dosing of abatacept in the Variable Dose Period.|||participants|||Number
2835384|NCT00254293|Secondary|Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS|The steady-state pharmacokinetic parameter AUC(TAU) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78 (TAU=7 days). Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001; Upper limit of quantification (ULOQ) was 0.030. AUC(TAU) measured in in micrograms*hours per milliliter (µg*h/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2835385|NCT00254293|Secondary|Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS|Peak serum concentration (Cmax) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78. Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001, Upper limit of quantification (ULOQ) was 0.030. Cmax measured in micrograms per milliliter(µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2835386|NCT00254293|Primary|Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)|Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Days 71 to 85|50 of the 51 abatacept-treated subjects were included. One subject who discontinued after receiving only Day 1 dosing was not included in this analysis.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2835387|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 2-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months after registered.|Per protocol population|||Probability of Progression-free Survival||95% Confidence Interval|Number
2835388|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 1-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date|12 months after registered.|Per protocol population|||probability of Progression-free Survival||95% Confidence Interval|Number
2835389|NCT00254163|Secondary|Objective Remission Rate (ORR)|"Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.~≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.~≥50% reduction in lymphadenopathy.~≥50% reduction in the size of the liver and/or spleen.~Polymorphonuclear leukocytes ≥ 1,500/mm^3 or 50% improvement over baseline.~Platelets >100,000/mm^3 or 50% improvement over baseline.~Hemoglobin >11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2835426|NCT00253370|Secondary|Overall Survival (OS)|Overall survival was defined as the time from registration to death from any cause.|Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.|||Months||90% Confidence Interval|Median
2836111|NCT00244985|Secondary|Overall Survival (OS) Rate at 2 Years|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|2 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2835390|NCT00254163|Secondary|Complete Remission (CR)|"Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.~Complete remission (CR) requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be <1 cm.~No evidence of hepatomegaly or splenomegaly.~Absence of constitutional symptoms.~Normal CBC as exhibited by:~Polymorphonuclear leukocytes ≥ 1,500/mm^3~Platelets > 100,000/mm^3~Hemoglobin > 11.0 g/dL (untransfused)~Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.~Lymphoid nodules should be absent."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2835391|NCT00254163|Secondary|Mean Absolute Neutrophil Count (ANC) at Post-treatment|mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment|2 months post-treatment|Per protocol population|||10^3 cells/mm^3||Standard Deviation|Mean
2835392|NCT00254163|Secondary|Hematologic Recovery|defined as Hb >11g/dL and a platelet count >100 × 10^3/mm^3|2 months post-treatment|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2835393|NCT00254163|Secondary|Percentage of Patients Hospitalized|Percentage of patients who were hospitalized due to any reasons during the study period.|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants|||Number
2835394|NCT00254163|Secondary|Infective Event Rate|infective events=temperature >101 without symptoms or temp <101 with symptoms|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of infective events|||Number
2835395|NCT00254163|Primary|Infection Rate|infection=febrile events requiring treatment|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2835396|NCT00254072|Primary|Number of Participants With Postoperative Gastrointestinal Hemorrhage||30 days||||participants|||Number
2835397|NCT00253981|Primary|Visual Analog Scale|Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.|4 weeks|||||||
2835398|NCT00253890|Primary|Sleep Quality, as Measured by Total Sleep Time|Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.|Baseline to 1-month|Intent to Treat|||minutes||Standard Deviation|Mean
2835399|NCT00253747|Secondary|Point-prevalence Abstinence|A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level <8 ppm.|Week 11|Evaluable population determined as for primary outcome.|||participants|||Number
2835400|NCT00253747|Secondary|Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale|A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0[none]-3[severe]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant's ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale.|Baseline and Study weeks 1,4,7,9,11|Evaluable participants determined using criteria for same in the primary outcome.|||DSM IV ADHD Score||Standard Deviation|Mean
2835401|NCT00253747|Primary|Prolonged Abstinence|"The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. Smoking days were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports."|Weeks 7-10|Randomized participants who complete at least two visits during the first four weeks following randomization, who reach the full dose of OROS-MPH /Placebo, who have a OROS-MPH /placebo medication compliance rate of at least 75% each week for study weeks 4 through 10, and who attend at least one meeting after initiating the nicotine patch.|||participants|||Number
2835402|NCT00253708|Secondary|Sleep|Sleep (Richards-Campbell) 0 = best sleep to 50 = worst sleep|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
2835403|NCT00253708|Secondary|Quality of Life: McGill Total|Quality of Life (McGill Total); Mean of five sub-measures (but not overall) (0 = negative to 10 = positive)|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
2835404|NCT00253708|Secondary|Quality of Life: Psychological Well-being|Psychological well-being over past 2 days (depressed, nervous/worried, sad, terrified of future) (0= always/extremely to 10= never/not at all; in other words: 0=negative/worst to 10= positive/best)|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
2835405|NCT00253708|Secondary|Quality of Life: Physical Well-being|Physical well-being over past 2 days (0= physically terrible to 10= physically well)|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
2835406|NCT00253708|Primary|Alertness|0=not at all alert to 10=most alert|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
2835407|NCT00253708|Primary|Anxiety|0=no anxiety to 10=most severe anxiety|From baseline to 1 week and from baseline to 1 month||||units on a scale||Inter-Quartile Range|Median
2835408|NCT00253708|Primary|Pain|0=no pain to 10=most severe pain|From baseline to 1 week and from baseline to one month||||units on a scale||Inter-Quartile Range|Median
2835410|NCT00253643|Primary|Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)|Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.|Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.|||units on a scale||Standard Deviation|Mean
2835411|NCT00253630|Secondary|2-Year Progression Free-Survival|Estimated using the product-limit method of Kaplan and Meier. Progression defined as any new lesion or increase by greater than 50% of previously involved sites from nadir.|Until death or progression, up to 2 years||||percentage of participants||95% Confidence Interval|Number
2835412|NCT00253630|Secondary|2-Year Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until Death from any cause, up to 2 years||||percentage of participants||95% Confidence Interval|Number
2835413|NCT00253630|Secondary|Change in Histone Acetylation by Western Blot (WB)|Histone acetylation by WB will be recorded as the ratio of acetylated histone (measured by photodensitometry) divided by the total histone (H3 or H4), in order to control for the amount of protein loaded. Analysis will be descriptive, with the goal of describing baseline distributions and estimating the frequency and degree of changes from baseline.|Baseline to up to day 14|Western Blot data was not collected and is not available for analysis.||||||
2835414|NCT00253630|Secondary|Change in Histone Acetylation by Immunohistochemistry (IHC)|Histone acetylation by IHC will be scored as -, +, ++, or +++, reflecting both the intensity of staining as well as the number of cells stained. Analysis will be descriptive, with the goal of describing baseline distributions and estimating the frequency and degree of changes from baseline.|Baseline to up to day 14|Immunohistochemistry data was not collected and is not available for analysis.||||||
2835415|NCT00253630|Primary|Number of Participants With Adverse Events|Grades 3 & 4 adverse events definitely, probably or possibly related to treatment, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|Up to 3 years||||Participants|||Count of Participants
2835416|NCT00253630|Primary|Response Rate|Radiological assessment by CT and/or PET scan after every three cycles (every 3 months). Response assessed by the standard Cheson criteria (Cheson et al, J Clin Oncol 17:1244, 1999). Complete Remission (CR) - (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT; Partial Remission (PR) - 50% or greater decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. Response Rate = CR + PR.|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
2835417|NCT00253513|Secondary|Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.||One year||||participants|||Number
2835418|NCT00253513|Primary|Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)|NRM (Non relapse mortality) - death not attributed to the primary cancer.|200 days||||percent of participants||95% Confidence Interval|Number
2835419|NCT00253513|Primary|Number of Patients Experiencing Graft Failure|Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.|42 days|For graft failure 2 of the 60 patients were not evaluable because they exeperienced another event (relapsed) before they could be evaluable for graft failure.|||participants|||Number
2835420|NCT00253513|Primary|Number of Patients Experiencing Regimen-related Toxicity Events in Study Population|Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal|34 days and 2 years||||participants|||Number
2835421|NCT00253448|Primary|Overall Survival After Treatment|Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years|Minimum of 5 years.||||months||95% Confidence Interval|Median
2835422|NCT00253435|Secondary|Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS|"Dose limiting veno-occlusive disease (VOD) defined as:~the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin > grade 1, PLUS~the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution"|Between start of MIBG treatment and 60 days post stem cell infusion|All patients who began treatment|||participants|||Number
2835423|NCT00253435|Secondary|Engraftment DLT|"• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:~neutrophils (ANC) < 500/μL by day 28 post transplant, or~platelets < 20,000 /μL by day 56 post transplant, or~if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets."|From treatment start until 60 days post stem cell infusion|All patients who began treatment|||participants|||Number
2835424|NCT00253435|Secondary|Event-free Survival (EFS) at 3 Years|EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.|3 years since start of treatment|Estimated probability of 3-year progression free survival for all patients enrolled in each risk group.|||Estimated probability|||Number
2835425|NCT00253435|Primary|Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion|Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).|Response assessed 60 days post stem cell infusion|One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response.|||participants|||Number
2835427|NCT00253370|Secondary|Progression-free Survival (PFS)|"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions."|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.|||Months||90% Confidence Interval|Median
2835428|NCT00253370|Primary|The Proportion of Patients With Objective Response (Complete Response or Partial Response)|Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.|||Proportion of patients||90% Confidence Interval|Number
2835429|NCT00253019|Primary|Continuation Rates|We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.|3 months|It was a convenience sample.|||participants|||Number
2835430|NCT00252967|Secondary|Comparison of Tumor Necrosis Factor Alpha Values||Baseline and 30 days||||ng/mL||Inter-Quartile Range|Median
2835431|NCT00252967|Secondary|Comparison of High Sensitivity C-reactive Protein||Baseline and 30 days||||mg/L||Inter-Quartile Range|Median
2835432|NCT00252967|Secondary|Comparison of Interleukin-1 Values||Baseline and 30 days||||ng/mL||Inter-Quartile Range|Median
2835433|NCT00252967|Secondary|Comparison of Interleukin-6 Values||Baseline and 30 days||||ng/mL||Inter-Quartile Range|Median
2835434|NCT00252967|Secondary|Comparison of Isoprostanes Values||Baseline and 30 days||||pg/mL||Inter-Quartile Range|Median
2835435|NCT00252967|Secondary|Comparison of Derivatives of Reactive Oxygen Metabolites Values||Baseline and 30 days||||Carr||Inter-Quartile Range|Median
2835436|NCT00252967|Secondary|Comparison of Redox Potential for Glutathione Values||Baseline and 30 days||||mV||Inter-Quartile Range|Median
2835437|NCT00252967|Secondary|Comparison of Redox Potential for Cysteine Values||Baseline and 30 days||||mV||Inter-Quartile Range|Median
2835438|NCT00252967|Primary|Time of Atrial Fibrillation Recurrence||Upon recurrence, up to 12 months||||days||Inter-Quartile Range|Median
2835439|NCT00252733|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
2835440|NCT00252733|Primary|Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.|Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
2835441|NCT00252720|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randimized patients with any post-randomization data.|||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
2835442|NCT00252720|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population whick includes all randomized patients with any post-randomization data.|||Participants|||Number
2835443|NCT00252720|Secondary|Number of Participants With a Regression of Diabetic Retinopathy.|Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to the end of the study, i.e., 5 years|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
2835444|NCT00252720|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention to Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
2835445|NCT00252694|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.|From Baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||log (µg/min)/1000 year||95% Confidence Interval|Least Squares Mean
2835446|NCT00252694|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
2835447|NCT00252694|Secondary|Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
2835448|NCT00252694|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.|||Participants|||Number
2835449|NCT00252629|Primary|The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.|"IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.~We expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans."|On a full night polysomnogram||||percentage of flow limited breaths||Standard Deviation|Mean
2835450|NCT00252629|Secondary|Change of Cognitive Dysfunction|Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.|3 weeks treatment with either therapeutic or sham CPAP||||units on a scale||Standard Deviation|Mean
2835451|NCT00252629|Secondary|Change of Pain Complaint|"Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.~We compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP"|3 weeks of treatment on either therapeutic or sham nasal CPAP||||units on a scale||Standard Deviation|Mean
2835452|NCT00252629|Primary|Change of Fatigue Symptom|Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.|3 weeks treatment with either therapeutic or sham CPAP||||units on a scale||Standard Error|Mean
2835453|NCT00252590|Secondary|Percentage of Days Abstinent From All Substances|Percentage of days abstinent from both alcohol and drugs|4 months||||percentage of days abstinent||Standard Deviation|Mean
2835454|NCT00252590|Primary|Percentage of Days Abstinent From Alcohol||4 months||||percentage of days abstinent alcohol||Standard Deviation|Mean
2835455|NCT00252577|Primary|Time to Relapse|The primary outcome measure was time to relapse in months following stabilization on lithium.|every 2 months for 2 years|outpatients at VA San Diego Healthcare System|||months||95% Confidence Interval|Mean
2835456|NCT00252564|Secondary|Objective Response Rate|"Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all per-protocol population patients."|12 months|This analysis included all eligible and treated patients, i.e. per-protocol population. A patient will be considered in the arm he/she is actually treated, not randomized.|||percentage of participants||95% Confidence Interval|Number
2835457|NCT00252564|Secondary|Overall Survival (OS)|"From randomization to death (event); or last follow-up date if alive (censoring).~Kaplan-Meier OS median time."|up to 4 years|ITT population.|||Months||95% Confidence Interval|Median
2835458|NCT00252564|Primary|Progression-free Survival (PFS) Rate at 1 Year.|From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).|12 months|ITT population.|||proportion of participants w/ PFS at 1yr||95% Confidence Interval|Number
2835459|NCT00252564|Primary|Progression-Free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).~Kaplan-Meier median PFS time and PFS rate (at 12 months)"|12 months|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.|||months||95% Confidence Interval|Median
2835460|NCT00252538|Primary|Phenotype and Genotype Based on Presence of Interferon Induced MDD.|"Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings.~Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study.~In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression."|The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.|This is an observational study that segregates patients with HCV and on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD. total sample from multiple sites.|||participants|||Number
2835461|NCT00252512|Secondary|Employment Status|Number of participants identifying themselves as unemployed.|8 week, 6 month and 12 month follow up|Fewer participants completed 6 and 12 month follow up assessments compared to 8 week follow up assessment.|||Participants|||Count of Participants
2835465|NCT00252512|Secondary|Psychiatric Status|"Kessler Psychological Distress Scale (K10) - score range 10 to 50.~score under 20 are likely to be well~score 20-24 are likely to have mild psychological distress~score 25-29 are likely to have moderate psychological distress~score 30 and over are likely to have a severe psychological distress"|8 weeks, 6 months, 12 months|Fewer participants completed 6 and 12 month follow-up assessments than completed 8 week assessment.|||units on a scale||Standard Deviation|Mean
2835466|NCT00252512|Primary|Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16||8 weeks||||negative alcohol and drug screens||Standard Deviation|Mean
2835467|NCT00252499|Secondary|Change in Hepatic Insulin Sensitivity From Baseline to 6 Months|Hepatic insulin sensitivity was determined as the percent suppression of endogenous glucose production (EGP) at the end of the low dose insulin clamp.|6 months||||percent of baseline EGP||Standard Error|Mean
2835468|NCT00252499|Secondary|Changes in Intra-abdominal Fat Area From Baseline to 6 Months|Unenhanced CT scan images were obtained on a General Electric Discovery HD750 CT scanner. Intra-abdominal (IAF) areas were measured at the top of the iliac crest and quantified using the Tomovision program (SliceOMatic V4.3) by one trained technologist.|6 months||||mm2||Standard Error|Mean
2835469|NCT00252499|Secondary|Change in Peripheral Insulin Sensitivity From Baseline to 6 Months|A two-step stable isotope labeled, hyperinsulinemic-euglycemic clamp procedure was performed with a low dose insulin infusion (20 mU/m2/min) for 3 hours followed by a primed high dose insulin infusion (160 mU/m2/min x 5 minutes then 80 mU/m2/min) for two hours. D20 was infused and adjusted to maintain the blood glucose at 90 mg/dl. Samples for glucose, insulin and 6,6 2d glucose were drawn every 15 minutes during the final half hour of the basal, low dose and high dose insulin periods. Whole body insulin sensitivity was calculated as the rate of glucose disposal (Rd)/lean body mass during the high dose insulin infusion.|6 months|One person in Arm 1 dropped out and thus is lacking 6 month data. The 6 month isotope data to calculate the rate of glucose disposal was not available for one subject in Arm 3.|||mg/min/kg||Standard Error|Mean
2835470|NCT00252499|Secondary|Change in the Liver Spleen Ratio by CT Scan From Baseline to 6 Months as a Measure of Fat in the Liver||6 months||||ratio||Standard Error|Mean
2835471|NCT00252499|Secondary|Change in Alanine Aminotransferase (ALT) Levels From Baseline to 6 Months||6 months||||U/L||Standard Error|Mean
2835472|NCT00252499|Primary|Liver/Spleen Ratio at 6 Months|Liver fat was estimated by non-contrast CT scan measuring the density ratio between the liver and spleen by Hounsfield units (liver/spleen ratio), which has been previously correlated with liver fat quantification by magnetic resonance spectroscopy.Ten separate measurements equally distributed throughout the liver and spleen were obtained and the Hounsfield units averaged. In subjects with more than one slice through the liver and spleen, the values for all slices were averaged.|6 months||||ratio||Standard Error|Mean
2835473|NCT00252382|Secondary|Best Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (PD); Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).|168 days|Efficacy Analysis Population|||Participants|||Count of Participants
2835474|NCT00252382|Primary|Objective Tumor Response Rate|ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|168 days|Efficacy Analysis Population|||Participants|||Count of Participants
2835475|NCT00252239|Primary|Functional Handicap (Modified Rankin Score)|The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported.|3 months||||percentage of participants|||Number
2835476|NCT00252187|Secondary|Change in Left Ventricular Ejection Fraction at 8 Weeks|Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).|Baseline and 8 weeks|Per protocol population|||percentage||Standard Deviation|Mean
2835477|NCT00252187|Secondary|Change in Blood Pressure at 8 Weeks|Blood pressure was measured during the MRI|Baseline and 8 weeks|Per protocol population|||mmHg||Standard Deviation|Mean
2835478|NCT00252187|Secondary|Change in Heart Rate at 8 Weeks|Heart rate was measured when MRI was performed|Baseline and 8 weeks|Per protocol population|||beats per minute||Standard Deviation|Mean
2835479|NCT00252187|Primary|Change in Left Ventricular (LV) Mass Index at 8 Weeks||Baseline and 8 weeks|Per protocol population|||mg/m^2||Standard Deviation|Mean
2835480|NCT00252187|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks|Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body-surface area. A lower GFR means the kidney is not filtering normally.|Baseline and 8 weeks|Per protocol population|||ml/min/1.73 m^2 of body-surface area||Standard Deviation|Mean
2835481|NCT00252187|Secondary|Change in Plasma Renin Activity at 8 Weeks|Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.|Baseline and 8 weeks|Per protocol population|||nanograms per milliliter per hour||Standard Deviation|Mean
2835482|NCT00252187|Secondary|Change in Left Ventricular (LV) Filling Pressure at 8 Weeks|Filling pressure determined by ratio of E/e' [Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio]|Baseline and 8 weeks|Per protocol population|||E/e'||Standard Deviation|Mean
2835483|NCT00252187|Primary|Change in Left Ventricular (LV) Volume Index at 8 Weeks|LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.|Baseline and 8 weeks|Per protocol population|||ml/m^2||Standard Deviation|Mean
2835484|NCT00252174|Secondary|Beck Hopelessness Scale (BHI)|Established self-report measure of depression and hopelessness, consisting of 20 true-false questions, with scores ranging from 0 to 20, with scores of 0-3 indicating minimal hopelessness and scores of 15-20 severe hopelessness.|Obtained over 3 months of study|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835485|NCT00252174|Secondary|Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS)|Daily self-report measure for anxiety.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835486|NCT00252174|Secondary|The Hospital Anxiety and Depression Scale (HADS)|"Standardized assessment of anxiety and depression consisting of a 7-item anxiety scale and a 7-item depression scale. Each scale score ranges from 0 to 21, with 0-7 being normal and 11-21 being abnormal [e.g. severely depressed or anxious]"|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835487|NCT00252174|Secondary|Daily Experience of Pain - Visual Analog Pain Scale (VAPS)|daily measure of self-reported pain.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835488|NCT00252174|Secondary|Daily Use of Anxiolytics - Daily Diary|daily log of anxiolytic medication usage.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835489|NCT00252174|Secondary|Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD)|standardized questions to evaluate extent of depression and thoughts of death.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835490|NCT00252174|Secondary|Hamilton Depression Rating Scale (HAM-D)|Standardized interview assessing of depression, with higher scores indicative of greater depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835491|NCT00252174|Secondary|Quality of Life - Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (FACIT-Sp),Karnofsky Performance Rating Scale (KPRS), Memorial Symptom Assessment Scale (MSAS), Mini-Mental Status Exam (MMSE), Self-Expansiveness Level Form|paper pencil tests capturing data on spiritual well-being, overall functioning living with cancer, psychiatric mental status, and on spiritual self-perception.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835492|NCT00252174|Secondary|Anxiety - Hamilton Anxiety Rating Scale (HAM-A)|standardized assessment of anxiety|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835493|NCT00252174|Primary|Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)|"Self-report instrument assessing quality of life with five functional scales, and nine symptom scales. Higher functional scores indicate better quality of life and higher symptom scores indicate poorer quality of life. Scales include Yes / No responses and four-point Likert scales, with transformations performed on scores so that all scale scores range from 0 to 100."|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835494|NCT00252174|Primary|Spielberger State-Trait Anxiety Inventory (STAI)|Established self-report measure of anxiety containing a State and Trait subscale and scored on a four-point Likert scale. Scores for each subscale range from 10 to 40 and combined from 20 to 80 with higher scores indicative of greater anxiety.|Obtained over the 3 months of active participation|Data has been damaged/lost in a flood that destroyed the office that contained much of the primary source material||||||
2835495|NCT00252057|Primary|Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.|The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.|30 days after discharge||||Total number of rehospitalizations|||Number
2835496|NCT00251979|Secondary|Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period||Within 30 days||||days|||Number
2835497|NCT00251979|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days||||blood units|||Number
2835498|NCT00251979|Secondary|Number of Blood Units Transfused Within 72 Hours||Within 72 hours||||blood units|||Number
2835499|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 30 Days||Within 30 days||||Participants|||Number
2835500|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 72 Hours||Within 72 hours||||Participants|||Number
2835501|NCT00251979|Secondary|Requirement for Surgery Within 30 Days||Within 30 days||||Participants|||Number
2835502|NCT00251979|Secondary|Requirement for Surgery Within 72 Hours||Within 72 hours||||Participants|||Number
2835503|NCT00251979|Secondary|Death Related to Rebleeding Within 30 Days as Judged by the EpC||Within 30 days||||Participants|||Number
2835504|NCT00251979|Secondary|Death Within 30 Days||Within 30 days||||Participants|||Number
2835505|NCT00251979|Secondary|Death Within 72 Hours||Within 72 hours||||Participants|||Number
2835506|NCT00251979|Secondary|Clinically Significant Rebleeding Within 30 Days||Within 30 days||||Participants|||Number
2835507|NCT00251979|Secondary|Clinically Significant Rebleeding Within 7 Days||Within 7 days||||Participants|||Number
2835508|NCT00251979|Primary|Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo||Within 72 hours||||Participants|||Number
2835509|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn|At 5 year visit||||participants|||Number
2835510|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn|At 5 year visit||||participants|||Number
2835511|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn|At 5 year visit||||participants|||Number
2835512|NCT00251927|Secondary|Los Angeles (LA) Grade C at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
2835513|NCT00251927|Secondary|Los Angeles (LA) Grade 'B' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
2835514|NCT00251927|Secondary|Los Angeles (LA) Grade 'A' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
2835515|NCT00251927|Secondary|Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit|Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included|At 5 year visit||||percentage of time recorded||Standard Deviation|Mean
2835516|NCT00251927|Secondary|Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit|The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included|At 5 year visit||||units on a scale||Standard Error|Mean
2835517|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn|At 5 year visit||||participants|||Number
2835518|NCT00251927|Secondary|Los Angeles (LA) Grade 'Normal' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit||||participants|||Number
2835519|NCT00251927|Primary|Number of Participants With Treatment Failure at 5 Years|Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.|During 5 years||||participants|||Number
2835520|NCT00251862|Secondary|Screening Intentions|"Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for not at all sure to 5 for completely sure."|Immediate post-intervention study visit||||units on a scale||Standard Deviation|Mean
2835521|NCT00251862|Secondary|Patient Satisfaction With Decision Making Process|"Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for strongly disagree (or poor) to 5 for strongly agree (or excellent). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data."|Immediate post-intervention primary care provider (PCP) visit||||units on a scale||Standard Deviation|Mean
2835522|NCT00251862|Secondary|Patient Knowledge|Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.|Immediate post-intervention study visit||||units on a scale||Standard Deviation|Mean
2835523|NCT00251862|Primary|Patient Adherence (Test Completion)|Completion of a screening test within 12 months of the study visit.|12 months post-intervention|Intention to treat|||participants|||Number
2835524|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Standard Deviation|Mean
2835547|NCT00251641|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|16 weeks|All subjects who were randomized were included in the efficacy analysis (intent-to-treat [ITT]).|||Proportion of participants|||Number
2842400|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48||||L||Standard Error|Mean
2835525|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Inter-Quartile Range|Median
2835526|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Standard Deviation|Mean
2835527|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Inter-Quartile Range|Median
2835528|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Standard Deviation|Mean
2835529|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.|||percentage of days||Inter-Quartile Range|Median
2835530|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Standard Deviation|Mean
2835531|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.|||percentage of days||Inter-Quartile Range|Median
2835532|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
2835533|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
2835534|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
2835535|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
2842401|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48||||L||Standard Error|Mean
2835536|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|Week 8|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
2835537|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analysis were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment that was performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
2835538|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||Percentage of subjects|||Number
2835539|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||Percentage of subjects|||Number
2835540|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|8 weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||Percentage of subjects|||Number
2835541|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.|||percentage of subjects|||Number
2835542|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||percentage of subjects|||Number
2835543|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.|||Percentage of subjects|||Number
2835544|NCT00251641|Secondary|Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|26 weeks|ITT|||Proportion of participants|||Number
2835545|NCT00251641|Secondary|Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|16 weeks|ITT|||Proportion of participants|||Number
2835546|NCT00251641|Secondary|PASI75 Response at Week 26|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|26 weeks|Intent-to-treat|||Proportion of participants|||Number
2835548|NCT00251589|Secondary|Progression-free Survival|Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).|Day 1 to disease progression or death|"All patients as treated population with post-baseline data available to determine progression free survival.~Cohort A, Dose Level 1 (Amended), Cohort B, Dose Level 2 and Cohort A, Dose Level 1 (Original) are not represented in the below table as post-baseline data were not available to determine progression free survival."|||Days||Full Range|Mean
2835549|NCT00251589|Secondary|Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)|First documentation of Progressive Disease (PD) occurring > 8 weeks on study.|Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Disease Progression After Week 8.|||Participants|||Number
2835550|NCT00251589|Secondary|Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Progressive Disease as Best Response.|||Participants|||Number
2835551|NCT00251589|Secondary|Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Stable disease is defined as less than a radiographic partial response, but not progressive disease|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients treated population with post-baseline data available to determine Stable Disease as Best Response.|||Participants|||Number
2835552|NCT00251589|Post-Hoc|Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study.|After day 28 in the Phase II portion of the study|All patients as treated population in Cycles 2 and beyond of the Phase II portion of the study.|||Participants|||Number
2835553|NCT00251589|Primary|Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.|Day 1 to 28 in the Phase II portion of the study|All patients as treated population in Cycle 1 of the Phase II portion of the study.|||Participants|||Number
2835554|NCT00251589|Secondary|Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)|An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Unconfirmed Partial Response as Best Response.|||Participants|||Number
2835555|NCT00251589|Primary|Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.|Day 1 to 28 in the Phase I portion of the study|All patients as treated population in Cycle 1 of the Phase I portion of the study.|||Participants|||Number
2835556|NCT00251316|Primary|The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.||1 year||||Participants|||Number
2835557|NCT00251303|Primary|Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS)|CY-BOCS is a 0-40 point scale of obsessive-compulsive symptom severity, higher number indicates more severe obsessive-compulsive symptoms. Comparison of 12 weeks scores for placebo and riluzole groups.|12 weeks||||units on a scale||Standard Deviation|Mean
2835558|NCT00251303|Primary|Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I)||12 weeks||||participants|||Number
2835559|NCT00251238|Primary|Change From Baseline in Severity of Vasospastic Attacks|"Severity of the complains due to Vasospastic Attacks was measured using a 10-steps likert scale.~The scale ranged between 0 and 10, with higher scores indicating more severe attacks."|Baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2835560|NCT00251238|Primary|Duration of Vasospastic Attacks||minutes per day||||minutes||Standard Deviation|Mean
2835561|NCT00251238|Primary|Frequency of Vasospastic Attacks||Number of Vasospastic Attacks per day, for up to 10 weeks||||attacks per day||Standard Deviation|Mean
2835562|NCT00251225|Secondary|Overall Survival (OS)|OS is the amount of time in months from the date of registration to the date of death from any cause.|Up to 60 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib|||months||95% Confidence Interval|Median
2835563|NCT00251225|Secondary|Prostate-Specific Antigen (PSA) Response Rate|PSA response rate is the number of participants who experienced a best response of: complete response, CR (PSA less than or equal to 0.2 ng/mL, documented two or more times, a minimum of four weeks apart), partial response, PR (a decline in PSA by at least 50%, confirmed by a second PSA value four or more weeks later) or stable disease (does not qualify for CR, PR, Progression or Symptomatic Deterioration, at least 6 weeks after registration) / total number of analyzable patients.|Up to 12 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib|||percentage of patients|||Number
2835576|NCT00250835|Secondary|Progression-free Survival (PFS)|"The Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (Version 1.0) will be used to determine tumor response and progression. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions. Time to progression will be measured from the time of surgery or clinically documented down staging if surgery for whatever reason is not carried in the subject until there is evidence of PD.~Progression-free survival is reported as the percentage of patients who have not experienced progression of disease at three years post-surgery"|3 years after surgery||||percentage of evaluable participants||95% Confidence Interval|Number
2835564|NCT00251225|Primary|Overall Time To Progression (TTP)|TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 24 months|Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib|||months||95% Confidence Interval|Median
2835565|NCT00251004|Secondary|Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|at 12 months|Intention to treat (ITT) population.|||mL/min/1.73m^2|||Number
2835566|NCT00251004|Primary|Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.|12 months|Intention-to-treat population|||Percentage of Participants|||Number
2835567|NCT00251004|Secondary|Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation|"Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.~A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316."|12 months|Intention-to-treat (ITT) population.|||Percentage of participants|||Number
2835568|NCT00251004|Primary|Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.|12 months|Intention-to-treat (ITT) population|||Participants|||Number
2835569|NCT00250926|Primary|Time to Progression|Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|42 months|The median time to progression was not achieved as follow-up ended before half the participants had a PD event.|||months||Full Range|Median
2835570|NCT00250926|Primary|Time to Best Response||33.2 months||||Months||Full Range|Median
2835571|NCT00250926|Primary|Response Rate|"This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows.~A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed."|33.2 months|all enrolled patients|||participants|||Number
2835572|NCT00250926|Primary|Number of Participants With Adverse Events|This outcome measure was to assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.|33.2 months|All enrolled patients|||participants|||Number
2835573|NCT00250835|Secondary|Pelvic Local Control Rate|Pelvic local control rate is defined as the proportion of subjects who have no evidence of pelvic recurrence (by standard clinical assessment, including CT scan and clinical examination) at the final follow-up evaluation, out of all evaluable patients|Up to 3 years after surgery||||percentage of evaluable participants|||Number
2835574|NCT00250835|Secondary|Surgical Downstaging Rate|Downstaging rate after neoadjuvant treatment with combination oxaliplatin, capecitabine, celecoxib and concurrent radiation is defined as the proportion of patients whose pathological stage (stage at surgery) is different from their clinical stage (stage at baseline)|At surgery (up to 6 weeks after treatment)||||percentage of evaluable participants||95% Confidence Interval|Number
2835575|NCT00250835|Secondary|Incidence of Sphincter-sparing Surgery|Incidence of sphincter-saving surgery is defined as the proportion of subjects who do not have permanent colostomy at the final follow-up out of all evaluable patients.|At surgery (up to 6 weeks after end of treatment)||||percentage of evaluable participants||95% Confidence Interval|Number
2835577|NCT00250835|Secondary|Toxicity|"All toxicities encountered during the study will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.~Toxicity will be reported as the proportion of subjects experiencing Grades 3,4, and 5 adverse events (AEs) out of all evaluable patients"|Up to 3 years||||percentage of participants|||Number
2842562|NCT00143598|Secondary|Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding||During 2-year follow up||||participants|||Number
2835578|NCT00250835|Primary|Pathologic Complete Response (PCR)|The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes.|At surgery (up to 6 weeks after end of treatment)|Patients who continue on at least two of the three drugs for a minimum of 14 days are considered evaluable for the primary objective|||percentage of evaluable participants||95% Confidence Interval|Number
2835579|NCT00250718|Secondary|Toxicity||End of 2 cycles (cycle = 28 days)|Trial was terminated early due to low accrual; no data to report. Adverse event data for enrolled patients is reported in the adverse event results section.||||||
2835580|NCT00250718|Primary|Overall Response Rate (ORR), the Sum of Complete and Partial Responses|"Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0).~For CLL: complete remission (CR) requires the following for>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count<4,000/µL, 4) ANC>1,500/µL, 5) platelets>100,000/µL, 6) hemoglobin>11 g/dL, 7) bone marrow lymphocytosis<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for >=2 months 1) decrease in previously enlarged nodes, spleen, and liver by >=50%, 2) ANC>=1,500/µL or platelets>=100,000/µL, 3) hemoglobin>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets.~For MM, CR is no monoclonal protein (M-protein) in blood and urine and <5% plasma cells in bone marrow on >=2 determinations >=6 wk apart & stable bone disease & calcium levels. PR is>50% and >90% decreases in serum & urine M-protein, respectively, on >=2 occasions for >=6 wk, stable bone disease & calcium."|Up to 6 months after first on-study treatment|Trial was terminated due to low accrual; no data to report. An insufficient number of subjects were accrued to report data accurately.||||||
2835581|NCT00250705|Secondary|Secondary Outcome Measures Were the Clinical Global Impression--Improvement (CGI-I) Scales (NIMH, 1985a).|The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; or 7. Much worse)|6 weeks||||units on a scale||Standard Deviation|Mean
2835582|NCT00250705|Primary|Children's Aggression Scale-Parent Version|"CAS-P is a 33 item scale representing 5 domains of aggression: Items in a domain were computed based on two reference points. The first was based on a 5 point frequency range with 0 being best (never) and 4 (> 10 times being) worst. These same items were then adjusted such that more severe acts would be weighted more heavily compared to less severe aggressive behaviors. Within a domain, 0 was the best score. Worst score for the various aggression domains were: Verbal 26.16, Against Objects and Animals 11.8, Provoked 15.84, Initiated 17.84, and Use of Weapons 13.16."|6 weeks|ITT|||units on a scale||Standard Deviation|Mean
2835583|NCT00250705|Secondary|Secondary Outcome Measures Were the Clinical Global Impression-Severity (CGI-S) Scale (NIMH, 1985a).|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1. Normal, not at all ill; 2. Borderline mentally ill, 3. Mildly ill; 4. Moderately ill; 5. Markedly ill; 6. Severely ill; or 7. Among the most extremely ill patients.|6 weeks||||units on a scale||Standard Deviation|Mean
2835584|NCT00250705|Primary|Overt Aggression Scale-Modified (OAS-M)|"OAS-M divides aggressions into 4 subtypes: 1) verbal aggression, 2) property aggression, 3) self aggression (autoaggression), and 4) physical aggression. Each subtype has an initial score ranging from 0 (least aggressive) to 4 (most aggressive). The score for each subscale is further weighed (multiplied) by a constant: verbal scale's constant is 1 (max adjusted score of 4); property scale's constant is 2 (max adjusted score 8); self scale's constant is 3 (max adjusted score 12); and physical scale's constant is 4 (max adjusted score of 16). Within a given scale, 0 is the best score and maximum adjusted scale score is worst."|6 weeks|ITT|||units on a scale||Standard Deviation|Mean
2835585|NCT00250705|Primary|The Primary Outcome Efficacy Measure: Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993)|Rating of Aggression Against People and/or Property Scale (RAAPP) (Kemph et al 1993) is a global rating scale of aggression completed by clinicians. Score given based on following severity scale with subject assigned 1 number: Intolerable behavior-frequently physically attacks others and destroys property (5); Severe-occasionally physically attacks people and destroys property (4); Moderately 21); and No aggressiveness reported (1). A minimum score of 1 is best and a maximum score of 5 is worst. There are no subscale scores.|6 weeks|ITT|||units on a scale||Standard Deviation|Mean
2835586|NCT00250679|Secondary|Mean Values for Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second|Baseline (Visit 2), weeks 3, 13, 26||||Liters||Standard Deviation|Mean
2835587|NCT00250679|Secondary|Mean Values for Inspiratory Capacity|Inspiratory capacity is the maximum volume that can be inhaled.|Baseline (Visit 2), Weeks 3, 13, 26||||Liters||Standard Deviation|Mean
2835588|NCT00250679|Secondary|Mean Values for Subject Global Evaluations|The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), weeks 13, 26|ITT Population|||units on a scale||Standard Deviation|Mean
2835589|NCT00250679|Secondary|Mean Values for St. George's Respiratory Questionnaire|A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status.|Baseline (Visit 2), weeks 13, 26|ITT population|||units on a scale||Standard Deviation|Mean
2835590|NCT00250679|Secondary|Mean Values for Investigator Global Evaluations|The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), Weeks 13, 26|ITT population|||units on a scale||Standard Deviation|Mean
2835591|NCT00250679|Secondary|Mean Values for the 6-Minute Walk Test: Distance Walked in Meters|This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.|Baseline (Visit 2), week 13, week 26|ITT population|||meters||Standard Deviation|Mean
2837255|NCT00227305|Primary|Change From Baseline in Supine Pulse|Change from OL baseline to week 26 in supine pulse (bpm)|OL baseline to week 26|Number of participants with OL baseline and post treatment visits|||bpm||Standard Deviation|Mean
2835592|NCT00250679|Secondary|Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire|Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status.|visit 4 (week 13), visit 5 (week 26)|ITT population|||percent of participants|||Number
2835593|NCT00250679|Secondary|Percent (%) of Participants With an Improved Transitional Dyspnea Index|The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|visits 4 (week 13), visit 5 (week 26)|"ITT population. Percentages were based on the number of subjects with non-missing data.~Visit 4 n=115, 113, 114 Visit 5 n=108, 102, 103"|||percent of participants|||Number
2835594|NCT00250679|Secondary|Modified Medical Research Council Dyspnea Questionaire|Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.|Baseline (visit 2), weeks 13, 26|ITT Population|||units on a scale||Standard Deviation|Mean
2835595|NCT00250679|Secondary|Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire|Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status.|Visit 4 (week 13) , Visit 5 (week 26)|ITT Population|||Participants|||Number
2835596|NCT00250679|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire|Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
2835597|NCT00250679|Secondary|6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes|Mean change from baseline in distance walked (meters)|Post-Dose weeks 0, 13, 26|ITT Population|||meters||95% Confidence Interval|Mean
2835598|NCT00250679|Secondary|BODE Index|The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit.|Baseline (visit 2), weeks 13, 26|ITT Population|||units on a scale||Standard Deviation|Mean
2835599|NCT00250679|Secondary|Investigator Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
2835600|NCT00250679|Secondary|Subject Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
2835601|NCT00250679|Secondary|Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)|The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.|weeks 0,3,13,26|ITT Population|||Liters||95% Confidence Interval|Mean
2835602|NCT00250679|Secondary|Number of Participants With an Improved Transitional Dyspnea Index|The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|weeks 13, 26|ITT Population. Visit 4 n=115,113,114 Visit 5 n=108,102,103|||Participants|||Number
2835603|NCT00250679|Secondary|Transitional (Relative Change in) Dyspnea Index|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|weeks 13, 26|ITT Population|||units on a scale||95% Confidence Interval|Mean
2835604|NCT00250679|Secondary|Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline|Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method.|weeks 0,3,13,26|ITT Population. Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.|||Liter||95% Confidence Interval|Mean
2835605|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Actuations/Day||95% Confidence Interval|Mean
2835606|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Rescue medication usage during the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Days Used / Week||95% Confidence Interval|Mean
2835607|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Actuations / Day||95% Confidence Interval|Mean
2835608|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population|||Days Used / Week||95% Confidence Interval|Mean
2835609|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Heart Rate|Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm)|visit 6 (week 27)||||Participants|||Number
2837276|NCT00227266|Primary|Efficacy, Measured Through Motor Function Assessments||-4wks, 0, 3 mo, 6 mo, 12 mo|||||||
2835610|NCT00250679|Secondary|6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)|The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.|weeks 0,3,13,26|ITT population. An available cases analysis was performed with no imputation for missing data.|||Liter||95% Confidence Interval|Mean
2835611|NCT00250679|Secondary|Inspiratory Capacity Changes From Baseline|Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.|weeks 0,3,13,26|ITT Population This outcome was added as an amendment after the study was initiated; therefore approximately half of the ITT population had these assessments at baseline. An available cases analysis was performed with no imputation for missing data.|||Liter||95% Confidence Interval|Mean
2835612|NCT00250679|Secondary|Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts|New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.|visit 6 (week 27)|ITT Population|||Participants|||Number
2835613|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Potassium Evaluations|Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population|||Participants|||Number
2835614|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Glucose Evaluations|Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population|||Participants|||Number
2835615|NCT00250679|Secondary|Number of Participants With New 24-Hour Holter Monitoring Alerts|New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.|Visit 6 (week 27)|ITT Population|||Participants|||Number
2835616|NCT00250679|Primary|Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations|"Percent of participants with the adverse event specified.~SOC = system organ class."|Six months|ITT Population|||percent of participants|||Number
2835617|NCT00250588|Secondary|Asthma Symptoms|Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.|||participants|||Number
2835618|NCT00250588|Secondary|Counts of Patients With One or More Asthma-related Emergency Department Visits.|Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3.|||participants|||Number
2835619|NCT00250588|Primary|Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)|The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, & Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a 'problem' in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.|||units on a scale||Standard Error|Mean
2835620|NCT00250497|Secondary|Body Satisfaction|Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.|One year||||units on a scale||Standard Deviation|Mean
2835621|NCT00250497|Secondary|Unhealthy Weight Control Behaviors|Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.|One Year||||percentage of participants|||Number
2835622|NCT00250497|Secondary|Sedentary Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day|One Year||||average number of 30-minute blocks/day||Standard Deviation|Mean
2835623|NCT00250497|Secondary|Fruits and Vegetables||One year||||Servings/day||Standard Deviation|Mean
2835624|NCT00250497|Secondary|Level of Physical Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.|One year||||average number of 30-minute blocks/day||Standard Deviation|Mean
2835625|NCT00250497|Primary|Percent Body Fat|Measured with DEX-A at baseline and 1 year follow-up|Baseline and One year||||% body fat (DXA)||Standard Deviation|Mean
2835728|NCT00249249|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change in total cholesterol from baseline to Week 12|Baseline to 12 Weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||percent change||Standard Deviation|Mean
2835626|NCT00250484|Secondary|Medication Use (Medication Diary)|Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.|Baseline and end of treatment at approximately 1 year|Data was not collected. Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.||||||
2835627|NCT00250484|Secondary|Cognitive Assessment - Neuropsychological Battery|"Beck Depression Inventory (BDI), and Visual Analog Scale (VAS) for anxiety were assessed in subjects both as a baseline score before treatment was initiated as and upon conclusion of treatment.~BDI is a 0-63 scale increasing with depression severity. A score from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 28-63 indicates severe depression. Higher values represent a worse outcome.~VAS is a pain assessment ranging from 0-10 increasing with pain severity. High values represent a worse outcome."|Baseline and end of treatment at approximately 1 year||||units on a scale||Standard Deviation|Mean
2835628|NCT00250484|Primary|Pain (Visual Analog Scale, CGI, PGA)|Pain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.|1 year||||number of participants w/ reduced pain|||Number
2835629|NCT00250458|Secondary|Participants With Pain Relief at 2 Hours Postdose|Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.|2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2835630|NCT00250458|Primary|Participants With Elimination of Nausea at 2 Hours Postdose|Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.|At 2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).|||Participants|||Number
2835631|NCT00250432|Secondary|Number of Patients With a Favorable Overall Response.|"Number of patients with a favorable overall response, defined as a clinical response of cure or apparent cure along with a microbiological response of eradication or presumptive eradication at the End of Caspofungin Therapy."|90 Days|Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol.|||Participants|||Number
2835632|NCT00250432|Primary|Number of Patients Who Develop Significant Drug-related Adverse Events.|Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.|90 Days|All patients as treated population|||Participants|||Number
2835633|NCT00250276|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2835634|NCT00250276|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2835635|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Day 0-29) post vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835636|NCT00250276|Secondary|Number of Subjects With MSAEs|MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835637|NCT00250276|Secondary|Number of Subjects With (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Month 0 to Month 12|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835683|NCT00249769|Secondary|Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination|Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.|Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)|Per-protocol population; the analysis includes participants with valid serology results for measles antibody during retesting.|||mIU/mL||95% Confidence Interval|Geometric Mean
2835638|NCT00250276|Secondary|Number of Subjects With Medically Significant Adverse Events (MSAEs)|MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835639|NCT00250276|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Month 0 to Month 7|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835640|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835641|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835642|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.|||Participants|||Count of Participants
2835643|NCT00250276|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2835644|NCT00250276|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.|During the 7-days (Day 0-6) post-vaccination|The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2835645|NCT00250276|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18|Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .|At Month 2|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.|||Participants|||Count of Participants
2835646|NCT00250276|Secondary|Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 2|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.|||Participants|||Count of Participants
2835647|NCT00250276|Primary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18|Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.|At Month 7|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.|||Participants|||Count of Participants
2835648|NCT00250276|Primary|Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.|At Month 7|The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.|||Participants|||Count of Participants
2835649|NCT00249873|Secondary|Adjudicated Major Bleedings|The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug).|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
2835650|NCT00249873|Secondary|Death From Any Cause (Cardiovascular and Noncardiovascular)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
2835651|NCT00249873|Secondary|Occurrence of Stroke|The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
2835652|NCT00249873|Primary|First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication|"The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :~stroke (nonfatal or fatal)~myocardial infarction (nonfatal or fatal)~non-CNS systemic embolism~vascular death~The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group."|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient’s compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.|||participants|||Number
2835653|NCT00249834|Secondary|Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate|Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|35-42 days post r-hCG administration|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||Percentage of subjects|||Number
2835654|NCT00249834|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|35-42 days post r-hCG administration|"ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here overall number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Percent sacs per embryo||Standard Deviation|Mean
2835655|NCT00249834|Secondary|Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose|As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||IU/day||Standard Deviation|Mean
2835656|NCT00249834|Secondary|Number of Subjects Needing Dose Adjustment|Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|6 days post r-hFSH treatment|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||subjects|||Number
2835657|NCT00249834|Secondary|Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH|As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||Percentage of cycles|||Number
2835658|NCT00249834|Secondary|Mean Number of Ovarian Stimulation Days|The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||Days||Standard Deviation|Mean
2835659|NCT00249834|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)|As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|up to end of stimulation cycle (approximately 31 days)|ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.|||International Units (IU)||Standard Deviation|Mean
2835660|NCT00249834|Primary|Number of Oocytes Retrieved|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.|Ovum pick up day (34 to 38 hours post r-hCG administration)|"Intention-To-Treat (ITT) population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here overall number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Oocytes||Standard Deviation|Mean
2835661|NCT00249821|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP).|Baseline (randomization) until Month 12|The safety population included all the participants who received at least 1 dose of study medication.|||participants|||Number
2835662|NCT00249821|Secondary|Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."|||milligram/L (mg/L)||Standard Deviation|Mean
2835663|NCT00249821|Secondary|Insulin Like Growth Factor-1 (IGF-1) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."|||microgram/liter (mcg/L)||Standard Deviation|Mean
2835664|NCT00249821|Secondary|Change From Baseline in Bone Age at Month 12|Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method.|Baseline (randomization) and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."|||years||Standard Deviation|Mean
2835665|NCT00249821|Secondary|Change From Baseline in Height at Month 6||Baseline (randomization) and Month 6|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.|||cm||Standard Deviation|Mean
2835666|NCT00249821|Secondary|Height Velocity-Standard Deviation Score (HV-SDS)|Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity.|Month 6 and Month 12|"FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Here n signifies number of participants analyzed at that particular time point for each arm group respectively. LOCF was used to impute missing values."|||standard deviation score||Standard Deviation|Mean
2835667|NCT00249821|Secondary|Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12|Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) [age and sex-matched reference]. Greater H-SDS indicates greater height.|Baseline (randomization), Month 6 and Month 12|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.|||standard deviation score||Standard Deviation|Mean
2835668|NCT00249821|Primary|Height Velocity|Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely: HV = {(h-hp)/(d-dp)} * 365.25 [centimeter (cm)/year] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years. HV is the mean height velocity over the interval between d and dp but is displayed as HV at d.|Month 12|Full Analysis (FA) set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Last observation carried forward (LOCF) was used to impute missing values.|||centimeter (cm)/year||Standard Deviation|Mean
2835669|NCT00249808|Secondary|Percentage of Participants With Psoriasis Exacerbation|Exacerbation was defined as disease worsening either during or after treatment which was more inflammatory in nature compared to baseline and occurred either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease.|During study (40 weeks)|ITT population. Here, overall number of participants analyzed = participants who failed to respond (PGA less than good) at Week 12.|||percentage of participants|||Number
2835684|NCT00249769|Secondary|Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination|Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).|Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2835727|NCT00249249|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|percent change from baseline in high density lipoprotein-cholesterol (HDL-C)|Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||percent change||Standard Deviation|Mean
2835670|NCT00249808|Secondary|Percentage of Participants With Psoriasis Rebound|Rebound was defined as worsening of disease as assessed by Psoriasis Area and Severity Index (PASI) score >125% of baseline or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 2 months of stopping therapy. PASI is an instrument used to assess the extent of cutaneous psoriasis and to measure the effects of therapy. The PASI divides the body into four anatomical regions: head, trunk, upper limbs, and lower limbs. For each region, the evaluator assesses the severity of erythema, induration/thickness and scaling and determines the percentage of the region affected by disease. A numerical PASI score is derived that evaluates the severity of symptoms in terms of the total body surface area affected. Total PASI score ranges from 0 to 72, with higher scores indicating more severe disease.|Up to 8 weeks after end of FT (up to Week 20)|Observation population included all participants had stopped treatment with efalizumab following the FT (Week 12) and who had responded to treatment during (PGA good or better ) FT. Here, overall number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2835671|NCT00249808|Primary|Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT)|The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant's present condition to baseline. PGA response includes: Cleared (100 percent [%] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported.|Week 12|ITT population.|||percentage of participants||95% Confidence Interval|Number
2835672|NCT00249795|Secondary|First Hospitalisation for Other Cardiovascular (CV) Cause|The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
2835673|NCT00249795|Secondary|First Hospitalisation for Heart Failure (HF)|The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
2835674|NCT00249795|Secondary|First Occurrence of Any Heart Failure (HF) Episode|The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
2835675|NCT00249795|Secondary|Death From Any Cause|The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.|||participants|||Number
2835676|NCT00249795|Secondary|First Occurrence of Stroke|The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
2835677|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication|The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.|||participants|||Number
2835678|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication|The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient's compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.|||participants|||Number
2835679|NCT00249769|Secondary|Number of Participants Experiencing Unsolicited Adverse Events (AE)||Up to 7 days post-vaccination|Safety population|||Participants|||Count of Participants
2835680|NCT00249769|Secondary|Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine|Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.|Up to 7 days after measles vaccination|Participants who received measles vaccine|||Participants|||Count of Participants
2835681|NCT00249769|Secondary|Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)|Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.|Up to 7 days after LJEV administration|Participants who received LJEV|||Participants|||Count of Participants
2835682|NCT00249769|Secondary|Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination|Assayed by plaque reduction neutralization test (PRNT).|Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)|Per-protocol population|||titer||95% Confidence Interval|Geometric Mean
2835721|NCT00249249|Secondary|Apo-B:Apo-A1 Ratio|Ratio of Apo-B to Apo-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||ratio||Standard Deviation|Mean
2845511|NCT00115297|Secondary|The Number of Participants Requiring Rescue Beta Agonist Use||Measured during the daytime||||participants|||Number
2835685|NCT00249769|Primary|Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination|Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.|Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)|The per-protocol population includes randomized participants who received at least one vaccine dose excluding participants who did not meet the inclusion/exclusion criteria or were found non-compliant to the immunization or blood sampling schedule. The analysis includes participants with valid serology results for measles antibody during retesting.|||percentage of participants||95% Confidence Interval|Number
2835686|NCT00249613|Primary|Any Substance Use Past 30 Days|Substance use in past 30 days at 12 months post intake|12 Months||||Odds ratio||95% Confidence Interval|Number
2835687|NCT00249613|Secondary|Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model|Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models|12 month post intake||||Beta coefficient||95% Confidence Interval|Number
2835688|NCT00249613|Primary|Predictors of Criminal Activity at 12 Months Post Intake||12 Months||||Odds ratio||95% Confidence Interval|Number
2835689|NCT00249613|Primary|Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment||baseline and 1-year follow-up|Intention to treat (ITT)|||Percentage reporting criminal activity|||Number
2835690|NCT00249496|Secondary|HIV Risk Behaviors|Percentage of people reporting that they traded sex for drugs or money|1 year|intent to treat|||percentage of participants||Full Range|Mean
2835691|NCT00249496|Secondary|Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates|"(The number of Monday, Wednesday and Friday urine samples negative for opiates/total number of urine samples) x 100.~We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial."|1 year|This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data.||||||
2835692|NCT00249496|Secondary|Percentage of 30-day Assessment Urine Samples Negative for Opiates|(The number of monthly urine samples negative for opiates/total number of urine samples) x 100|1 year|intent to treat|||percentage of opiate negative||Full Range|Mean
2835693|NCT00249496|Secondary|Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine|"(The number of Monday, Wednesday and Friday urine samples negative for cocaine/total number of urine samples) x 100.~We have not confirmed the accuracy/completeness of the Mon, Wed, Fri urine data at this point. In addition, the monthly data had less missing data than the Monday, Wednesday and Friday data and were sufficient to show the main results of the trial."|1 year|This measure was not analyzed due to limited funding to confirm the accuracy/completeness of the Mon, Wed, Fri urine data||||||
2835694|NCT00249496|Primary|Percentage of Monthly Urine Samples That Are Negative for Cocaine|The percentage of urine samples collected at monthly assessments that are negative for cocaine.|1 year||||percentage of urine samples||Full Range|Mean
2835695|NCT00249470|Secondary|HIV Risk Behaviors|Report no injection drug use or crack cocaine use.|every month for 6 months|The data represent the mean percentage of participants that reported no injection drug use or crack cocaine use. Missing assessments were considered positive (i.e., injection drug or crack cocaine use).|||percentage of participants||Full Range|Mean
2835696|NCT00249470|Secondary|Percent Opiate Negative|(total number of opiate-negative urine samples divided by the total number of urine samples provided)*100|every month for 6 months|intent to treat|||percentage of opiate negative||Full Range|Mean
2835697|NCT00249470|Primary|Cocaine Abstinence|Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine|6 months||||percentage of cocaine negative||Full Range|Mean
2835698|NCT00249444|Primary|Depression Score on Hamilton - Depression 25 Item|Participants those who had a 50% decrease in HAM-D scores from baseline at end of study. The outcome measured is 50% drop in Hamilton score at week 8 or last week of study participation compared to baseline. We looked at the difference between baseline score and score at week 8 or last week of study participation.|End of 8 week study or last week of participation||||participants|||Number
2835699|NCT00249444|Primary|Cocaine Abstinence During Last Three Weeks of Study|measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation|measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation||||participants|||Number
2835700|NCT00249379|Secondary|Recidivism Rates|Number of participants returning to jail during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
2835701|NCT00249379|Secondary|Retention in Drug Court|Number of participants remaining in drug treatment court program during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
2835702|NCT00249379|Primary|Level of Acceptance|Number of participants taking study medication during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
2835703|NCT00249379|Primary|Drinking and Other Drug Use|Number of participants using alcohol and other drugs during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."|||participants|||Number
2835722|NCT00249249|Secondary|Apolipoprotein-A1 (Apo-A1)|Apolipoprotein-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/dL||Standard Deviation|Mean
2844195|NCT00127439|Primary|Kinematics: Minimum Hip Angle - Extension|Hip angle at maximal hip extension during stepping|12 weeks||||degrees||Standard Deviation|Mean
2835704|NCT00249288|Secondary|Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients|Baseline blood homocysteine lab levels are reported by deficit syndrome status.|Baseline|One participant without deficit syndrome is missing homocysteine. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are compared across deficit syndrome status.|||micromoles/liter||Standard Deviation|Mean
2835705|NCT00249288|Secondary|Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients|Baseline blood B12 lab levels are reported by deficit syndrome status.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across deficit syndrome status.|||picograms/mL||Standard Deviation|Mean
2835706|NCT00249288|Secondary|Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients|Baseline blood folate lab levels are reported by deficit syndrome status.|Baseline|One deficit syndrome participant and one participant without deficit syndrome are missing RBC folate values. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across deficit syndrome status.|||nanograms/mL||Standard Deviation|Mean
2835707|NCT00249288|Primary|Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake|Baseline blood folate and B12 lab levels and dietary intake levels are reported.|Baseline|All participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, folate and B12 levels are described for all baseline participants.|||micrograms||Standard Deviation|Mean
2835708|NCT00249288|Primary|Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake|Baseline blood homocysteine lab levels and dietary intake levels are reported.|Baseline|All study participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are described for all baseline participants.|||micromoles/liter||Standard Deviation|Mean
2835709|NCT00249288|Primary|Correlation Between Baseline Serum B12 Levels and Dietary Intake|Baseline serum B12 lab levels and dietary intake levels are reported.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are described for all baseline participants.|||picograms/mL||Standard Deviation|Mean
2835710|NCT00249288|Primary|Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype|Baseline blood homocysteine lab levels are reported by MTHFR genotype.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, homocystein levels are compared across MTHFR genotype.|||micromoles/liter||Standard Deviation|Mean
2835711|NCT00249288|Primary|Correlation Between Baseline Blood B12 Levels and MTHFR Genotype|Baseline blood B12 lab levels are reported by MTHFR genotype.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across MTHFR genotype.|||picograms per milliliter||Standard Deviation|Mean
2835712|NCT00249288|Primary|Correlation Between Baseline Homocysteine Levels and Smoking Status|Baseline blood homocysteine lab levels are reported by smoking status.|Baseline|1 participant who have never smoker status is missing plasma homocysteine values. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are compared across smoking status.|||micromoles per liter||Standard Deviation|Mean
2835713|NCT00249288|Primary|Correlation Between Baseline Serum B12 Levels and Smoking Status|Baseline serum B12 lab levels are reported by smoking status.|Baseline|For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across smoking status.|||picograms per milliliter||Standard Deviation|Mean
2835714|NCT00249288|Primary|Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total|The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score). The SANS modified total score is the SANS total score minus the Attention subscale.|Baseline score vs. week 12 score||||Units on a scale||Standard Deviation|Mean
2835715|NCT00249288|Primary|Correlation Between Baseline Blood Folate Levels and Dietary Intake|Baseline blood folate lab levels and dietary intake levels are reported.|Baseline|All study participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, folate levels are described for all participants at baseline.|||nanograms/mL||Standard Deviation|Mean
2835716|NCT00249288|Primary|Correlation Between Baseline Blood Folate and MTHFR Genotype|Baseline blood folate lab levels are reported by MTHFR genotype.|Baseline|One participant with CC genotype is missing RBC folate value. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across MTHFR genotype.|||nanograms/mL||Standard Deviation|Mean
2835717|NCT00249288|Primary|Correlation Between Baseline Blood Folate and Smoking Status|Baseline blood folate lab levels are reported by smoking status.|Baseline|1 past smoker and 1 never smoker are missing RBC folate values. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across smoking status.|||nanograms per milliliter||Standard Deviation|Mean
2835718|NCT00249249|Secondary|National Cholesterol Education Program [NCEP]LDL-C Target Attainment|Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)|up to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||Patients|||Number
2835719|NCT00249249|Secondary|Oxidized LDL at 12 Weeks|oxidized low density lipoprotein at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||U/L||Standard Deviation|Mean
2835720|NCT00249249|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks|high sensitivity C-reactive protein (hs-CRP) at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.|||mg/L||Standard Deviation|Mean
2837277|NCT00227266|Primary|Safety Labs|Participants will have labs drawn regularly to maintain appropriate dosing and monitor liver function|-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs|||||||
2835730|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 months|Treated population of participants with a non-index lesion.|||percentage of stenosis|||Number
2835731|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 9|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|9 months|Treated population of participants with a non-index lesion.|||percentage of stenosis||Standard Deviation|Mean
2835732|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 24|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|24 weeks|Treated population of participants with a non-index lesion.|||percentage of stenosis||Standard Deviation|Mean
2835733|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 weeks|Treated population of participants with a non-index lesion.|||percentage of stenosis||Standard Deviation|Mean
2835734|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 months|Treated population of participants with an index lesion at this site.|||percentage of stenosis|||Number
2835735|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|9 months|Treated population of participants with an index lesion at this site.|||percentage of stenosis||Standard Deviation|Mean
2835736|NCT00249002|Secondary|Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks|The patency (unblocking) for index lesions is defined as <50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as <50% of stenosis and no new non-index lesions at 24 weeks.|24 weeks|Treated Population of evaluable participants|||percentage of participants|||Number
2835737|NCT00249002|Secondary|Kaplan Meier Estimates for Time to Graft Failure or Intervention|The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.|up to 12 months|Treated population|||weeks||95% Confidence Interval|Median
2835738|NCT00249002|Secondary|Participants With Arthrosclerotic Cardiovascular Complications|Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.|up to week 25|Treated population|||participants|||Number
2835739|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|24 weeks|Treated population of participants with an index lesion at this site.|||percentage of stenosis||Standard Deviation|Mean
2835740|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 weeks|Treated population of participants with an index lesion at this site.|||percentage of stenosis||Standard Deviation|Mean
2835741|NCT00249002|Primary|Percentage of Participants Without Graft Failure or Need for Intervention|Graft failure is defined as graft thrombosis, loss of vascular access function, or >50% stenosis of the index lesion at the time of a regularly scheduled angiographic assessment.|24 weeks|Evaluable participants who were treated|||percentage of participants|||Number
2835742|NCT00249002|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 21|Treated population|||percentage of participants|||Number
2835743|NCT00248833|Secondary|Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion|Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion|26 weeks|Number of participants analyzed represents subjects who experienced increases from baseline|||% of subjects|||Number
2835744|NCT00248833|Secondary|Weeks to Serconversion|Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development.|26 weeks|Number analyzed are subjects that seroconverted|||Weeks||Standard Deviation|Mean
2835745|NCT00248833|Primary|Safety: Adverse Event Type Summarized by Dose|Adverse events summarized by type and dose|7 days after each vaccination|Both 25ug groups (1 and 2) were grouped for this analysis as both groups received the same dosage|||Number of AEs|||Number
2845512|NCT00115297|Secondary|Wheezing at Day 7||Study day 7||||participants|||Number
2835749|NCT00248794|Primary|Independent Living Skills Survey|"Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as washes hair twice a week, and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning."|16 weeks after intake||||units on a scale||Standard Error|Mean
2835750|NCT00248794|Primary|Hopkins Verbal Learning Test- Total Recall Variable|This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.|16 weeks post intake assessment||||units on a scale (T-scores)||Standard Deviation|Mean
2835751|NCT00248794|Primary|Continuous Performance Task X/A Version|CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.|16 weeks after intake assessment||||units on a scale (standardized units)||Standard Deviation|Mean
2835752|NCT00248794|Primary|Bell Lysaker Emotion Recognition Test|21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.|16 weeks from intake|Two way ANOVA using baseline and completion of intervention data|||total correct||Standard Deviation|Mean
2835753|NCT00248794|Primary|Wisconsin Card Sort Percent Perseverative Errors (Standard Score)|"This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects density of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance."|16 weeks after intake||||standard score units||Standard Deviation|Mean
2835754|NCT00248781|Secondary|Six-minute Walk (Durability)|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|12 months||||m||Standard Deviation|Mean
2835755|NCT00248781|Secondary|Tandem Stance (Durability)|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|12 months||||s||Standard Deviation|Mean
2835756|NCT00248781|Secondary|Single Leg Stance With Eyes Open (Durability)|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|12 months||||s||Standard Deviation|Mean
2835757|NCT00248781|Secondary|Knee Flexion Strength (Durability)|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|12 months||||kg||Standard Deviation|Mean
2835758|NCT00248781|Primary|Six-minute Walk|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|6 months|The number of subjects completing 6 month evaluations|||m||Standard Deviation|Mean
2835759|NCT00248781|Primary|Tandem Stance|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|6 months|The number of subjects completing 6 month evaluations|||s||Standard Deviation|Mean
2835760|NCT00248781|Primary|Single Leg Stance With Eyes Open|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|6 months|The number of subjects completing 6 month evaluations|||s||Standard Deviation|Mean
2835761|NCT00248781|Primary|Knee Flexion Strength|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|6 months|Number of subjects completing 6 month evaluations|||kg||Standard Deviation|Mean
2835762|NCT00248781|Secondary|Knee Extension Strength (Durability)|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|12 months||||kg||Standard Deviation|Mean
2835763|NCT00248781|Primary|Knee Extension Strength|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|6 months|number of subjects completing 6 month evaluations|||kg||Standard Deviation|Mean
2835764|NCT00248651|Secondary|Dyspepsia-Specific Quality of Life|The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life.|12 Weeks|The intent-to-treat analysis included all randomized subjects.|||units on a scale||95% Confidence Interval|Mean
2835765|NCT00248651|Secondary|Maximum Tolerated Volume by Nutrient Drink Test|The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure.|12 weeks|The intent-to-treat analysis included all randomized subjects.|||ml||Standard Deviation|Mean
2835766|NCT00248651|Secondary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|12 weeks|The intent-to-treat analysis included all randomized subjects.|||minutes||Standard Deviation|Mean
2844196|NCT00127439|Primary|Kinematics: Minimum Thigh Angle|Greatest thigh angle for hip flexion during stepping|12 weeks||||degrees||Standard Deviation|Mean
2835767|NCT00248651|Primary|Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment|The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.|3 weeks through 12 weeks|The intent-to-treat analysis included all randomized subjects.|||percentage of participants|||Number
2835768|NCT00248638|Secondary|Mean Heat Shock Proteins Level, HSP27|Levels of the heat shock protein, HSP27, will be measured in pg/mL from baseline to day 28. Higher levels indicate a higher protein presence.|Baseline, Day 3, Day 7, Day 14, Day 21, Day 28|The number of participants currently hospitalized are included in each time point analysis.|||pg/mL||Standard Deviation|Mean
2835769|NCT00248638|Secondary|Mean Heat Shock Proteins Level, HSP70|Levels of the heat shock protein,HSP70, will be measured in ng/mL from baseline to day 28. Higher levels indicate a higher protein presence.|Baseline, Day 3, Day 7, Day 14, Day 21, Day 28|The number of participants currently hospitalized are included in each time point analysis.|||ng/mL||Standard Deviation|Mean
2835770|NCT00248638|Secondary|Mean Glutathione Level|Glutathione (GSH) levels will be measured in µM (micro moles) from baseline to day 28. Higher levels indicate a higher GSH presence.|Baseline, Day 3, Day 7, Day 14, Day 21, Day 28|The number of participants currently hospitalized are included in each time point analysis.|||µM||Standard Deviation|Mean
2835771|NCT00248638|Primary|Percentage of Patients Who do Not Develop Hospital Infections|Subjects remaining infection-free during the hospitalization.|Current Hospitalization (Up to 6 Months)||||percentage of participants|||Number
2835772|NCT00248638|Primary|Hospital Mortality Rate|Number of participants who died during hospitalization.|Current Hospitalization (Up to 6 Months)||||participants|||Number
2835773|NCT00248625|Secondary|Infectious Complication||Within 7 days of randomization||||Participants|||Number
2835774|NCT00248625|Secondary|Highest Coma Grade of Hepatic Encephalopathy|West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants > 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing.|Within 7 days of randomization|All enrolled participants where coma grade could be assessed. Four participants (two in each randomization arm) could not have coma grade assessed during the 7 days after randomization.|||participants|||Number
2835775|NCT00248625|Secondary|Number of Organ Systems Failing||Within 7 days of randomization||||participants|||Number
2835776|NCT00248625|Secondary|Categorized Length of ICU Stay|The length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases.|Within 7 days of randomization||||participants|||Number
2835777|NCT00248625|Secondary|Length of Hospital Stay||Randomization to hospital discharge|All participants enrolled in study with hospital stay information, 2 participants (1 in each arm) did not have hospital discharge information.|||days||Inter-Quartile Range|Median
2835778|NCT00248625|Secondary|Cumulative Percent Incidence of Transplantation by 1 Year||Within 1 year of randomization||||percentage of participants|||Number
2835779|NCT00248625|Secondary|Spontaneous Recovery|Survival without liver transplantation|One year following randomization|All participants enrolled in study|||participants|||Number
2835780|NCT00248625|Primary|Survival|Spontaneous survival without transplant plus survival following transplantation|One year following randomization|All participants who were enrolled in the study were included in the survival analysis|||Participants|||Number
2835781|NCT00248612|Secondary|HAM-D Scale|HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression.|Session 1 (baseline), Session 8 (8 weeks of treatment)||||units on a scale||Standard Deviation|Least Squares Mean
2835782|NCT00248612|Secondary|HAM-A Scale|The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where <17 indicates mild anxiety, 18-24 moderate anxiety and 25-30 severe anxiety. Higher scores reflect more anxiety.|Session 1 (baseline), Session 8 (8 weeks of treatment)||||units on a scale||Standard Deviation|Least Squares Mean
2835783|NCT00248612|Secondary|DASS Stress Subscale Score|DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress.|Session 1 (baseline), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Least Squares Mean
2835784|NCT00248612|Secondary|Medication Compliance Rates|The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts.|12 months||||percentage of participants|||Number
2835785|NCT00248612|Secondary|Treatment Completion|The number and percent of participants that completed the treatment in each arm of the study.|12 months||||Participants|||Count of Participants
2835786|NCT00248612|Primary|Number of Participants Abstinent|Abstaining from the consumption of intoxicating beverages.|Session 8 (8 weeks of treatment)||||Participants|||Count of Participants
2835807|NCT00248495|Primary|Pathologically Complete Response|Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.|1 year|ll treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2835787|NCT00248612|Primary|Craving Desire Scale (CDS)|"The Craving Desire Scale (CDS) is a 3-item scale (1. I do want to drink now, 2. I crave a drink right now, 3. I have a desire for a drink right now) used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol."|1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Mean
2835788|NCT00248612|Primary|Clinical Global Impression Scale-S (CGI-S)|"Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time?~(1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)"|1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Mean
2835789|NCT00248612|Primary|Clinical Global Impression Scale-I (CGI-I)|"Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed?~(1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)"|Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)||||units on a scale||Standard Deviation|Mean
2835790|NCT00248560|Secondary|Toxicity as Measured by Number and Grade of Adverse Events|Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event|Every 2 weeks||||participants|||Number
2835791|NCT00248560|Secondary|Survival|Overall Survival using the Kaplan-Meier method|Every 8 weeks||||months||95% Confidence Interval|Median
2835792|NCT00248560|Secondary|Response Duration|Response duration in months|Every 8 weeks|Only those patients that have a recorded CR or PR|||months||80% Confidence Interval|Median
2835793|NCT00248560|Primary|Response (Complete Response [CR] + Partial Response [PR])|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks for approximately 8 - 48 weeks||||participants|||Number
2835794|NCT00248547|Secondary|Pharmacokinetic Interaction|To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.|Up to three weeks|||||||
2835795|NCT00248547|Secondary|Effects on Nausea, Appetite and Taste Changes|To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.|Up to three weeks|||||||
2835796|NCT00248547|Secondary|Safety in Transplant Population|To assess the safety of aprepitant in the bone marrow transplant population|Up to three weeks|||||||
2835797|NCT00248547|Primary|Number of Emesis Free Participants During the Study Period.|To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period|Up to three weeks||||Participants|||Number
2835798|NCT00248534|Secondary|6-month Progression-free Survival|"Scan at 6 months~Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks~Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression"|6 months||||percentage of participants||95% Confidence Interval|Number
2835799|NCT00248534|Secondary|1 Year Overall Survival Rate||1 year||||percentage of participants||95% Confidence Interval|Number
2835800|NCT00248534|Secondary|Number of Participants Alive at 3 Years|The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.|3 years|One patient died prematurely, one patient withdrew consent before first scan (during induction), 13 patients came off study due to progression of disease.|||Participants|||Count of Participants
2835801|NCT00248534|Primary|Percentage of Participants With Objective Response|Objective response rate of the combination of Rituximab and TMZ|2 months|2 patients were not evaluable, one died prematurely and the other withdrew consent before the first scan (during induction cycle)|||percent of participants||95% Confidence Interval|Number
2835802|NCT00248495|Secondary|Percent Change in SUV Level Between Pre and Post Chemotherapy|Percent change of PET/SUV levels between baseline and post-chemotherapy.|Baseline and post-chemotherapy|All treated and eligible patients|||Percentage change in SUV level||Standard Deviation|Mean
2835803|NCT00248495|Secondary|Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT||1 year|No participants were analyzed as there was no budget left to do the analysis.||||||
2835804|NCT00248495|Secondary|Disease Free Survival|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first.|At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months|All treated and eligible patients|||months||95% Confidence Interval|Median
2835805|NCT00248495|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|Every 6 months until the time of death up to 126 months|All treated and eligible patients|||months||95% Confidence Interval|Median
2835806|NCT00248495|Secondary|Number of Participants With Adverse Events|Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail.|1 year|All treated and eligible patients|||Participants|||Count of Participants
2835808|NCT00248287|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population|||months||95% Confidence Interval|Median
2835809|NCT00248287|Secondary|Median Time of Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|2 years|ITT population|||months||95% Confidence Interval|Median
2835810|NCT00248287|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|||months||Full Range|Median
2835811|NCT00248287|Primary|Objective Response Rates (ORR)|To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable population|||Percentage of Participants||95% Confidence Interval|Number
2835812|NCT00248170|Secondary|Percentage of Participants Who Experienced Cardiovascular Events|The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.|||Percentage of participants|||Number
2835813|NCT00248170|Secondary|Percentage of Participants Who Experienced Clinical Fracture Events|The incidence of clinical fractures was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.|||Percentage of participants|||Number
2835814|NCT00248170|Secondary|Change From Baseline in Serum Lipid Profiles|Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.|baseline, 6, 12, 24, 36, 48 and 60 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.|||mg/dL||95% Confidence Interval|Mean
2835815|NCT00248170|Secondary|Distant Disease-free Survival|Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
2835816|NCT00248170|Secondary|Time to Development of Contra Lateral Breast Cancer|Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
2835817|NCT00248170|Secondary|Time to Development of Distant Metastases|Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
2835818|NCT00248170|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
2835819|NCT00248170|Primary|Disease Free Survival|Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.|||Months||95% Confidence Interval|Median
2835820|NCT00248040|Secondary|Graft Survival Rate|Graft failure was defined as the failure of graft function for any reason, ultimately requiring renal replacement therapy and/or retransplantation (United States Renal Data System [USRDS] 2017.|at Month 1, Month 6 and Month 12|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||number of grafts|||Number
2835821|NCT00248040|Secondary|Patient Survival Rate|Numbers of patients alive, dead, and lost to follow up are reported.|at Month 1, Month 6 and Month 12|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||Participants|||Count of Participants
2835822|NCT00248040|Secondary|Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12|Acute rejection defined as an increase in serum creatinine level after exclusion of other causes of graft dysfunction, accompanied by a sudden decline in glomerular filtration rate and renal function and well-established diagnostic features on kidney allograft biopsy which can be either antibody-mediated and/or T cell-mediated and can occur at any time after transplant.|at Month 6 and between Month 6 and Month 12|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||episodes|||Number
2835823|NCT00248040|Secondary|Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12|Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a rapid and cost-effective method for the measurement of renal function.|at Month 1, Month 6 and Month 12|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||mL/min||Standard Deviation|Mean
2835824|NCT00248040|Secondary|Serum Creatinine at Month 1, Month 6 and Month 12|Serum creatinine (SrCr) was measured at Month 1, Month 6 and Month 12.|at Month 1, Month 6 and Month 12|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||mmo/L||Standard Deviation|Mean
2835825|NCT00248040|Secondary|Mortality|Mortality in the first 30 days post-transplant was evaluated.|first 30 days post-transplant|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||Participants|||Count of Participants
2835826|NCT00248040|Secondary|Duration of Hospital Stay|The mean duration of hospital stay was evaluated.|first 30 days post-transplant|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||days||Standard Deviation|Mean
2835827|NCT00248040|Secondary|Number of Patients With Immediate, Slow and Delayed Graft Function|"The number of patients who required dialysis within 7 days post-transplant was evaluated.~Immediate graft function: SrCr ≤3 mg/dL on post operative day 5) Slow graft function: SrCr >3 mg/dL dL on post operative day 5, no need of dialysis) Delayed graft function: Dialysis needed in the first week)"|day 5 post-transplant|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||Participants|||Count of Participants
2835828|NCT00248040|Secondary|Number of Days on Dialysis Before Resuming Kidney Function|the number of days on dialysis before resuming kidney function was evaluated.|up to Day 7 post-transplant|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||days||Standard Deviation|Mean
2835829|NCT00248040|Secondary|Number of Patients Requiring Dialysis Within 7 Days Post-transplant|The number of patients who required dialysis within 7 days post-transplant was evaluated.|up to day 7 post-transplant|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||Participants|||Count of Participants
2835830|NCT00248040|Secondary|Renal Function Tests - Urine Output|Urine output, measured in the interval from transplant to 8:00 of Day 1, and then daily from Day 2 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier|from Day 1 up to 7 days post-transplant or up to hospital discharge|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||mL||Standard Deviation|Mean
2835831|NCT00248040|Secondary|Renal Function Tests - Calculated Glomerular Filtration Rate|Calculated glomerular filtration rate (GFR) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis|from Day 1 up to 7 days post-transplant or up to hospital discharge|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||mL/min||Standard Deviation|Mean
2835832|NCT00248040|Secondary|Renal Function Tests - Serum Creatinine|Serum creatinine (SrCr) was measured daily from Day 1 up to 7 days post-transplant or up to hospital discharge, whichever occurred earlier; in patients undergoing dialysis, SrCr values were measured immediately before dialysis.|daily up to day 7 post-transplant or hospital discharge|The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||mmol/L||Standard Deviation|Mean
2835833|NCT00248040|Primary|Creatinine Clearance (CrCl) in the Immediate Post-transplant Period|"CrCl was determined by two 60 minute urine collections, during the time intervals 1-3 and 10-12 hours of allograft reperfusion. Blood was withdrawn at the midpoint of each urine collection. CrCl at each timepoint was calculated according to the formula:~creatinine clearance (mL/minutes) = urine creatinine (mmol/L) x urine volume (mL) / serum creatinine (mmol/L) x time of collection (minutes) An average was to be calculated from the two 60 minute values in each interval."|1-3 and 10-12 hours post allograft reperfusion|ITT population. The ITT population consisted of all randomized patients who received any Investigational Product(s) and a kidney transplant.|||mL/min||Standard Deviation|Mean
2835834|NCT00247962|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline|"ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a Yes (scored as 1) or No (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL)."|Baseline and 16 Weeks|The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.|||units on a scale||Standard Deviation|Mean
2835835|NCT00247962|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|16 weeks|All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.|||participants|||Number
2835836|NCT00247676|Secondary|Plasma Concentration of Soluble KIT (sKIT)|Plasma concentrations of sKIT that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
2835837|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
2835838|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline). Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
2835839|NCT00247676|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||pg/mL||Full Range|Median
2835840|NCT00247676|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of VEGF that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by e nzyme-linked immunosorbent assay (ELISA). Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT|||picograms (pg)/mL||Full Range|Median
2835841|NCT00247676|Secondary|Tissue Tumor Markers Assessed by Tumor Biopsy|Provision of previously collected tumor paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block) for correlative laboratory analysis was optional. For all subjects showing OR on study, it was highly recommended to provide previously collected paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block). These samples were to be analyzed for markers that may be associated with tumor proliferation or angiogenesis.|Day 28 of Cycle 1 (optional)|ITT. Tumor biopsy results were collected optionally in 5 subjects; however, no evaluations were performed.|||intensity score||Standard Deviation|Mean
2835842|NCT00247676|Secondary|Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)|Blood samples for the assessment of CECs and circulating CEPs were planned to be obtained for subjects in Part 1 of the study, and for a subset of subjects in Part 2 of the study to complete the angiogenic profile of unresectable hepatocellular carcinoma, in addition to the soluble protein evaluation.|Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1)|ITT. Blood samples for CECs and CEP cells were collected during the study, but evaluations of these samples were not performed.|||cells/mL||Standard Deviation|Mean
2835843|NCT00247676|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
2835844|NCT00247676|Secondary|Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
2835845|NCT00247676|Secondary|Dose-Corrected Ctrough of Sunitinib|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
2835846|NCT00247676|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
2835847|NCT00247676|Secondary|Ctrough of SU-012662 (Metabolite of Sunitinib)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK|||ng/mL||Standard Deviation|Mean
2835848|NCT00247676|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|Pharmacokinetic (PK) = All subjects enrolled in the study who at least 1 PK sample collected.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2835849|NCT00247676|Secondary|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year.|ITT|||Probability|||Number
2835850|NCT00247676|Secondary|Overall Survival (ITT Child Pugh Class A Subject Population)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT Child Pugh Class A (assessment of liver function) subject population|||Weeks||95% Confidence Interval|Median
2835851|NCT00247676|Secondary|Overall Survival (Overall ITT)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT|||Weeks||95% Confidence Interval|Median
2835852|NCT00247676|Secondary|Time to Tumor Progression (ITT Child Pugh Class A Subject Population)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT Child Pugh Class A (assessment of liver function) subject population|||Weeks||95% Confidence Interval|Median
2835853|NCT00247676|Primary|Objective Response (CR or PR)|Number of patients with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in patients with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT|||participants|||Number
2835854|NCT00247676|Secondary|Time to Tumor Progression (Overall ITT)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT|||Weeks||95% Confidence Interval|Median
2835855|NCT00247676|Secondary|Progression-Free Survival (ITT Child Pugh Class A Subject Population)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT Child Pugh Class A (assessment of liver function) subject population = subjects enrolled in the study with Child-Pugh Class A that received at least 1 dose of study medication.|||Weeks||95% Confidence Interval|Median
2844197|NCT00127439|Primary|Propulsion: Propulsive Impulse|Push-off force at toe off in N-s during treadmill stepping|12 weeks||||N-s||Standard Deviation|Mean
2835856|NCT00247676|Secondary|Progression-Free Survival (Overall ITT)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT|||Weeks||95% Confidence Interval|Median
2835857|NCT00247676|Secondary|Best Overall Response of PR or SD With Duration ≥12 Weeks|Number of patients with best overall response of PR or SD with duration ≥ 12 weeks. Best overall response was defined as the time from the first documentation of tumor response that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer|ITT|||participants|||Number
2835858|NCT00247676|Secondary|Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR, or SD for at least 12 weeks on study according to RECIST. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study|ITT|||participants|||Number
2835859|NCT00247676|Primary|Best Overall Response|Number of subjects with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ≥ 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of ≥ 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.|||participants|||Number
2835860|NCT00247676|Secondary|Duration of Objective Response (CR or PR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer|From the Overall ITT population, only 1 subject had Objective Response for evaluation of duration of objective response.|||Weeks|||Number
2835861|NCT00247624|Secondary|Insomnia Severity Index (ISI)|The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score, range 0-28. Lower scores represent better outcomes. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).|9 weeks||||units on a scale||Standard Deviation|Mean
2835862|NCT00247624|Primary|Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q is scored from 0-100, with higher scores better than lower. Measured weekly for 9 weeks. Reported as mean of 9 weeks.|9 weeks||||units on a scale||Standard Deviation|Mean
2835863|NCT00247624|Primary|Relation to Self/Others (RSO) Basis-32 Subscale Ratings|"The BASIS 32 psychometric includes several subscales, including relation to self and others (RSO). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension. Measured weekly for 9 weeks. Reported as mean of 9 weeks."|9 weeks||||units on a scale||Standard Deviation|Mean
2835864|NCT00247624|Primary|Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings|"The BASIS 32 psychometric includes several subscales, including daily living and role functioning (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks."|9 weeks||||units on a scale||Standard Deviation|Mean
2835865|NCT00247611|Post-Hoc|Percentage of Participants Unemployed and on Disability||Data collected at Baseline||||percentage of participant|||Number
2835866|NCT00247611|Primary|Visual Analog Scale Measure of Adherence to ART|"This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated.~See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77"|Measured at each clinical visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparisons replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.|||percent with 100% adherence|||Number
2835867|NCT00247611|Secondary|Viral Load Count|Viral load data extracted from medical records beginning 30 days prior to baseline.|Measured over 18 months||||percentage with undetectable viral load|||Number
2835887|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2835888|NCT00247273|Secondary|Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population|ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT|||ug / L||95% Confidence Interval|Least Squares Mean
2835889|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2835890|NCT00247273|Secondary|Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT|||ng / mL||95% Confidence Interval|Least Squares Mean
2845513|NCT00115297|Primary|Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)||First 56 days of study||||Days||Inter-Quartile Range|Median
2835868|NCT00247611|Primary|AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken|"This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained.~See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee & adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266."|Measured at each clinical care visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparison replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.|||percent with 100% adherence|||Number
2835869|NCT00247416|Secondary|Progression-free Survival|progression-free survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days||||days||95% Confidence Interval|Median
2835870|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Overall Survival.|Overall survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days||||days||95% Confidence Interval|Median
2835871|NCT00247416|Primary|Percentage of Participants With Reduction in Grade 3/4 Neutropenia|Reduction grade 3/4 neutropenia|continuous throughout treatment, up to 25 weeks||||percentage of participants|||Number
2835872|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Response Rate.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment||||percentage of responders out of total||95% Confidence Interval|Number
2835873|NCT00247377|Secondary|Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation|change in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835874|NCT00247377|Secondary|Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835875|NCT00247377|Secondary|Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835876|NCT00247377|Secondary|Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale.|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835877|NCT00247377|Secondary|Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835878|NCT00247377|Secondary|Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835879|NCT00247377|Secondary|Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835880|NCT00247377|Secondary|Cost of Procedure to the Medical Facility on Date of Procedure|operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery.|date of surgery||||dollars per patient||Standard Deviation|Mean
2835881|NCT00247377|Primary|Excess Weight Loss From Pre-operation to 5 Years Post-operation|weight loss as measured by change in percent of excess body weight|Baseline to 5 years|Availability of subjects and protocol design|||percent change||Standard Deviation|Mean
2835882|NCT00247377|Secondary|Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response where 0 is non-functioning and 100 is fully functioning|Baseline to 12 months||||units on a scale||Standard Deviation|Mean
2835883|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 24, ITT Population|At least 1 new fractured vertebra|Baseline to Month 24|ITT|||Participants|||Number
2835884|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 12, ITT Population|At least 1 new fractured vertebra|Baseline to Month 12|ITT|||Participants|||Number
2835885|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2835886|NCT00247273|Secondary|Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT|||ug / L||95% Confidence Interval|Least Squares Mean
2845779|NCT00113425|Secondary|Change From Baseline in Closed Comedones at Week 16||Baseline and Week 16||||closed comedones||95% Confidence Interval|Mean
2835892|NCT00247273|Secondary|Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population|ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT|||ng / mL||95% Confidence Interval|Least Squares Mean
2835893|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2835894|NCT00247273|Secondary|Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT|||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
2835895|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 6|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2835896|NCT00247273|Secondary|Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine|Baseline to Month 6|ITT|||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
2835897|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT|||g/cm^2||95% Confidence Interval|Least Squares Mean
2835898|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT|||Percent Change||95% Confidence Interval|Least Squares Mean
2835899|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).|Baseline to Month 24 - Endpoint|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2835900|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT|||g/cm^2||95% Confidence Interval|Least Squares Mean
2835901|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2835902|NCT00247273|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).|Baseline to Month 12 - Endpoint|ITT (intent to treat) Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2835903|NCT00246805|Primary|Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)|Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.|June 2009||||participants|||Number
2835904|NCT00246805|Secondary|Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization||January 2009|||||||
2835905|NCT00246805|Secondary|Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate||January 2009|||||||
2835906|NCT00246805|Secondary|Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation||January 2009|||||||
2835907|NCT00246805|Secondary|Evaluation of Rate Irregularity Indicators and Patient's Symptoms||January 2009|||||||
2835908|NCT00246753|Secondary|Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)|To assess the correlation between expression of molecular markers and patient response to treatment with GW572016|4 years|Data were not collected.||||||
2835909|NCT00246753|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.|4 years||||days||95% Confidence Interval|Median
2835910|NCT00246753|Primary|Number of Patients Experiencing Decline in Prostate-specific Antigen|Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.|4 years||||Participants|||Count of Participants
2835911|NCT00246740|Secondary|Venous Plasma Concentration of IL-6|Measurement of inflammation marker interleukin-6 in plasma|Before surgery and up to 72 h reperfusion after surgery||||pg/ml||Standard Error|Mean
2835912|NCT00246740|Secondary|Venous Plasma Concentration of C-reactive Protein|Measurement of inflammation marker C-reactive protein in plasma|Before surgery and up to 72 h reperfusion after surgery||||ng/ml||Standard Error|Mean
2835913|NCT00246740|Secondary|Cleaved TroponinI/GAPDH Ratios in Right Atrial Biopsy|Measurement of the ratios of cleaved TnI (troponin-I) versus GAPDH in biopsies collected from right atria. Measure is the ratio TnI/GAPDH|Before surgery and 10 minutes reperfusion after surgery||||Arbitrary units-Cleaved TnI/GAPDH||Standard Error|Mean
2835914|NCT00246740|Secondary|Venous Plasma Concentration of Troponin-I|Measurement of levels of TnI (troponin-I), a marker of cardiac cell damage|Before surgery and 10 minutes reperfusion after surgery||||pg/ml||Standard Error|Mean
2836799|NCT00234494|Primary|Progression Free Survival|- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.|36 months||||months||95% Confidence Interval|Median
2835915|NCT00246740|Secondary|Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion|Biochemical activity of MMP-2 activity in venous plasma, measured before surgery and up to 72h of reperfusion after surgery.|Before surgery and up to 72 h reperfusion after surgery||||Arbitrary units||Standard Error|Mean
2835916|NCT00246740|Secondary|Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion|Biochemical activity of MMP-9 activity in venous plasma, measured before surgery and up to 72h of reperfusion after surgery.|Before surgery and up to 72 h reperfusion after surgery||||Arbitrary units||Standard Error|Mean
2835917|NCT00246740|Secondary|Cardiac Matrix Metalloproteinase-2 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion|Biochemical activity of MMP-2 activity in right atrial biopsies, measured at 10 minutes of reperfusion after surgery.|Before surgery and 10 minutes reperfusion after surgery||||Arbitrary units||Standard Error|Mean
2835918|NCT00246740|Secondary|Cardiac Matrix Metalloproteinase-9 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion|Biochemical activity of MMP-9 activity in right atrial biopsies, measured at 10 minutes of reperfusion after surgery. To determine MMP-9 activity, 20 μg of total protein from both myocardial extracts and plasma were analyzed by gelatin zymography. For detailed methodology consult Cheung PY, Sawicki G, Wozniak M, et al: Matrix metalloproteinase-2 contributes to ischemia-reperfusion injury in the heart. Circulation 2000; 101:1833-1839|Before surgery and 10 minutes reperfusion after surgery||||Arbitrary units||Standard Error|Mean
2835919|NCT00246740|Primary|Left Ventricular Stroke Work Index (LVSWI)|Measure of global left ventricular function. The formula used for calculation is: LVSWI= SI x MAP x 0.0144 LVSWI = Left Ventricular Stroke Work Index (g*m/m2) SI = Stroke Index (mL/beat/m2) MAP = Mean Arterial Pressure (mmHg) 0.0144 is a conversion term to equalize units.|Before surgery up to 24h of reperfusion||||g*m/m2||Standard Error|Mean
2835920|NCT00246571|Secondary|Circulating Tumor Cells (CTC)|Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||cells/7.5 mL||Standard Deviation|Mean
2835921|NCT00246571|Secondary|Circulating Endothelial Cells (CEC)|Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||cells/mL||Standard Deviation|Mean
2835922|NCT00246571|Secondary|Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor|Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
2835923|NCT00246571|Secondary|Plasma Concentration of Soluble Placental Growth Factor (sPlGF)|Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
2835924|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)|Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
2835925|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)|Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.|||pg/mL||Standard Deviation|Mean
2835926|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. This outcome measure was not analyzed.|||pg/mL||Standard Deviation|Mean
2835927|NCT00246571|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)|Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
2835928|NCT00246571|Secondary|Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)|Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
2835929|NCT00246571|Secondary|Dose-corrected Ctrough of Sunitinib|Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
2835930|NCT00246571|Secondary|Ctrough of Total Drug (Sunitinib + SU012662)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
2835931|NCT00246571|Secondary|Ctrough of SU012662 (Metabolite of Sunitinib)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
2835932|NCT00246571|Secondary|Observed Plasma Trough Concentrations (Ctrough) of Sunitinib||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.|||ng/mL||Standard Deviation|Mean
2835933|NCT00246571|Secondary|HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.|||score on a scale|||Number
2835934|NCT00246571|Secondary|Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.|||score on a scale|||Number
2835935|NCT00246571|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to 3 years after first dose of study medication)|ITT population|||months||95% Confidence Interval|Median
2835936|NCT00246571|Secondary|Survival Probability at 1 Year|Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.|Baseline until death (up to 3 years after first dose of study medication)|ITT population|||ratio||95% Confidence Interval|Number
2835937|NCT00246571|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Time from first response to disease progression up to 3 years from first dose|ITT population|||months||95% Confidence Interval|Median
2835938|NCT00246571|Secondary|Proportion of Participants With Objective Response|Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population|||percentage of participants||95% Confidence Interval|Number
2835939|NCT00246571|Primary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)|Intent-to-Treat (ITT) population: all participants who were randomized.|||Months||95% Confidence Interval|Median
2835940|NCT00246519|Secondary|Adverse Metabolic Responses||9-18 weeks of treatment|||||||
2835941|NCT00246519|Primary|Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).||baseline to 18 weeks of treatment|A total 768 patients had at least monotherapy response data. Of the 386 patients assigned to the atenolol arm, 357 completed both drugs. Of the 382 assigned to the HCTZ arm, 355 completed both drugs. The delta blood pressure below is for patients who completed both drugs.|||mmHg||Standard Deviation|Mean
2835942|NCT00246441|Primary|Drinking to Cope|Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.|16 weeks treatment||||proportion of drinking days||Standard Error|Mean
2835943|NCT00246441|Primary|Alcohol Use, Quantity and Frequency|Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is >0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).|16 weeks treatment||||units on a scale||Standard Error|Mean
2835944|NCT00246441|Primary|Social Anxiety Severity|Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.|16 weeks treatment||||units on a scale||Standard Deviation|Mean
2835945|NCT00246376|Primary|Total Cholesterol : HDL-C Ratio|Total cholesterol : HDL-C ratio: Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||ratio||Standard Error|Mean
2835946|NCT00246376|Primary|Total Cholesterol|Total cholesterol (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dL||Standard Error|Mean
2835947|NCT00246376|Primary|HDL-C|HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.|||mg/dl||Standard Error|Mean
2835952|NCT00246337|Secondary|Sustained Pain Freedom|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."|||Participants|||Number
2835953|NCT00246337|Secondary|Sustained Pain Relief|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing"|||Participants|||Number
2835954|NCT00246337|Secondary|Pain Freedom at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."|||Participants|||Number
2835955|NCT00246337|Primary|Pain Relief at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."|||Participants|||Number
2835956|NCT00246324|Secondary|Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay||8 months|||||||
2835957|NCT00246324|Secondary|Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline||8 months|||||||
2835958|NCT00246324|Secondary|Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes|Only 1 patient relapsed. Correlations between decrease serum metalloproteinase 9 levels and enhancing lesion activity reduction. Transendothelial migration of monocytes was suppressed. Adverse effects were mild. No adverse synergistic effects of combination therapy.|8 months||||participants|||Number
2835959|NCT00246324|Primary|Gadolinium-enhancing (Gd+)Lesion Number Change.|Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.|8 months||||Gd+ lesions||95% Confidence Interval|Median
2835960|NCT00246259|Other Pre-specified|Abnormal Involuntary Movement Scale (AIMS)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none, 4=severe). Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dental status. Total scores range from 0 to 42 with higher values indicating more severity.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Units on a scale||Standard Deviation|Mean
2835961|NCT00246259|Other Pre-specified|Simpson Angus Scale (SAS)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The 10 items are rated on a 5-point scale (0=complete absence, 4=extreme presence) after a brief neurological examination and observation of the participants' gait (slow, shuffling walk). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Units on a scale||Standard Deviation|Mean
2835962|NCT00246259|Other Pre-specified|Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment|The BARS evaluates akathisia (feeling of restlessness) associated with the use of antipsychotic medications, including an objective and a subjective component plus a global impression. Components are rated on a scale of 0 (normal or absence of restlessness)-3 (intense restlessness) and 0 (absent)-5 (severe akathisia) for the global clinical assessment. Number of participants in each global clinical assessment scale are reported.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Participants|||Number
2835984|NCT00246025|Secondary|Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)|Number of Participants expressing DVT with symptoms|2 weeks|FAS−op - FAS−op includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.|||Percentage of participants|||Number
2835985|NCT00246025|Secondary|Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Proximal DVT during treatment period|2 weeks|FAS−pDVT - FAS−pDVT includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT.|||percentage of participants|||Number
2845780|NCT00113425|Secondary|Change From Baseline in Cysts at Week 16||Baseline and Week 16||||cysts||95% Confidence Interval|Mean
2835963|NCT00246259|Secondary|Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV|The SF-36 is a survey of participant health. It calculates two standardized scales: the standardized mental component scale and the standardized physical component scale. The standardized scales are calculated as weighted sums of the 8 scores, which are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range; and standardized mental component scale score is calculated as weighted average of individual item scores on a 0-100 range, where 100 signify highest level of functioning. The change from baseline in mental component scale score was reported.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2835964|NCT00246259|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV|The DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2835965|NCT00246259|Secondary|Total Words Score Over Time|Controlled Word Association Test (COWAT) was used to assess verbal fluency. Participants are given 3 different letters of the alphabet and asked to say as many words beginning with each letter within a controlled time. Participants are then asked to identify as many words as possible in 3 different categories (animals, fruits and vegetables) within a specified period of time. The total score is a sum of all three categories scores. The total score ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline, Week 104 or LRV|The ITT population:all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' signifies participants evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.|||Units on a scale||Standard Deviation|Mean
2835966|NCT00246259|Secondary|Number of Participants With Cognitive Assessments Using Trail B|Cognitive assessments were done using Trail test B, which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. In Trail B, 2 sets of circles contain numbers and letters, and the participant must connect them in alternating order. Trail B is also a measure of executive functions as it requires planning and decision-making.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.|||Participants|||Number
2835967|NCT00246259|Secondary|Number of Participants With Cognitive Assessment Using Trail A|Cognitive assessments were done using Trail test A which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. Participants must connect numbered circles in a variety of orders.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.|||Participants|||Number
2835968|NCT00246259|Secondary|Percentage of Participants With Relapse|"Relapse was defined according to Csernansky: Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as CGI-C score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) = participants evaluable for this measure.|||Percentage of participants|||Number
2835969|NCT00246259|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV|The HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. Total score ranges from 0 to 56. Lower score indicates less affected.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2835970|NCT00246259|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV|Co-morbid symptoms of mania are evaluated by change in YMRS Score which is an 11-item scale to assess symptoms of mania, Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (the least) to 60 (the worst).|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2835986|NCT00246025|Secondary|Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality|Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality|2 weeks|FAS-major - FAS-major includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT, PE, or VTE-related death.|||percentage of participants|||Number
2836342|NCT00242567|Secondary|Overall Survival at 18 Months and 3 Years|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.|month 18, year 3|The ITT Population will consist of all patients randomized to treatment.|||participants|||Number
2835971|NCT00246259|Secondary|Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV|Co-morbid depressive symptoms are evaluated by change in CDSS Score which was developed to assess symptoms of depression in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). It consists of 9 items, each scored from 0 (absent) to 3 (severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2835972|NCT00246259|Primary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV|The SOFAS focused exclusively on participants' level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2835973|NCT00246259|Primary|Time to Relapse|"Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment.|||Weeks||Standard Deviation|Mean
2835974|NCT00246259|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 104 or LRV|Intent-to-treat (ITT) analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. One participant was missing as reported in oral antipsychotic arm. 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2835975|NCT00246090|Secondary|Duration of Response|Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.|From first documented complete or partial response until disease progression or death|Eligible Population|||Days||Full Range|Median
2835976|NCT00246090|Primary|Objective Response Rate|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Every two cycles|Eligible Population|||Percentage of Participants|||Number
2835977|NCT00246025|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study||||participants|||Number
2835978|NCT00246025|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 0|Safety set|||mL||Standard Deviation|Mean
2835979|NCT00246025|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 0|Safety set|||participants|||Number
2835980|NCT00246025|Secondary|Number of Participants With Bleeding Events During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|2 weeks|Safety set - Safety set includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.|||participants|||Number
2835981|NCT00246025|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee.|2 weeks|FAS−op|||percentage of participants|||Number
2835982|NCT00246025|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.|2 weeks|FAS−op|||percentage of participants|||Number
2835983|NCT00246025|Secondary|Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Total DVT during treatment period|2 weeks|FAS−tDVT - FAS−tDVT includes all patients who were randomised, treated, operated, and had evaluable venogram or confirmed symptomatic DVT.|||percentage of participants|||Number
2836800|NCT00234286|Secondary|Individuals With a Palliative Care Consultation|Palliative Care Consultation based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2835987|NCT00246025|Primary|Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.|number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality|2 weeks study medication|Full analysis set (FAS) - Full analysis set includes all patients who were randomly assigned to the treatment, received at least one oral dose, went through surgery, had an evaluable venogram for distal and proximal DVT, or had confirmed symptomatic DVT or PE, or died.|||percentage of participants|||Number
2835988|NCT00246012|Other Pre-specified|Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.|Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
2835989|NCT00246012|Other Pre-specified|Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)|The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg*day/mL||Standard Deviation|Mean
2835990|NCT00246012|Secondary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.||||||
2835991|NCT00246012|Secondary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/kg||Standard Deviation|Mean
2835992|NCT00246012|Secondary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/day/kg||Standard Deviation|Mean
2835993|NCT00246012|Secondary|Half-life of Intetumumab - Phase 1 (Part 2)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
2835994|NCT00246012|Secondary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg*day/mL||Standard Deviation|Mean
2835995|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2835996|NCT00246012|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2|The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2835997|NCT00246012|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2|The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2845781|NCT00113425|Secondary|Change From Baseline in Pustule Acne Lesions at Week 16||Baseline and Week 16||||pustule acne lesions||95% Confidence Interval|Mean
2835998|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.|||mcg/mL||Standard Deviation|Mean
2835999|NCT00246012|Secondary|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2|Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.|Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.|||Days||95% Confidence Interval|Median
2836000|NCT00246012|Secondary|Duration of Response - Phase 2|Time duration required to achieve a CR or PR.|From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant’s listings, but not statistically summarized.||||||
2836001|NCT00246012|Secondary|Overall Survival (OS) - Phase 2|The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.|Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.|||Days||95% Confidence Interval|Median
2836002|NCT00246012|Secondary|Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2|The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
2836003|NCT00246012|Secondary|Percentage of Participants Who Achieved CR - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
2836004|NCT00246012|Secondary|Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.|||Percentage of Participants|||Number
2836005|NCT00246012|Primary|Progression-Free Survival (PFS) - Phase 2|The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.|From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication|The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment.|||Days||95% Confidence Interval|Median
2836006|NCT00246012|Primary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.||||||
2836007|NCT00246012|Primary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/kg||Standard Deviation|Mean
2836008|NCT00246012|Primary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/day/kg||Standard Deviation|Mean
2836057|NCT00245518|Primary|Body Pain as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836009|NCT00246012|Primary|Half-life of Intetumumab - Phase 1 (Part 1)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
2836010|NCT00246012|Primary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcg*day/mL||Standard Deviation|Mean
2836011|NCT00246012|Primary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2836012|NCT00246012|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1|The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.|Up to 21 days post-first infusion from the last treated participant in Phase 1|Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine.|||Participants|||Number
2836013|NCT00245960|Secondary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.|Efficacy measured by the number of subjects achieving Psoriatic Arthritis response criteria at 24 weeks last observed carried forward (LOCF).|24 weeks|The analysis population was the Modified Intent to Treat (mITT).|||participants|||Number
2836014|NCT00245960|Primary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis.|Efficacy measured by the number of subjects with a Physician Global Assessment of Psoriasis of clear or almost clear at 12 weeks last observation carried forward (LOCF).|12 weeks|The analysis population was the Modified Intent to Treat (mITT) population.|||participants|||Number
2836015|NCT00245856|Secondary|Bleeding Events|Total major bleeding rate|3 months|All DVT treated patients analyzed together|||participants||95% Confidence Interval|Number
2836016|NCT00245856|Primary|New Venous Thromboembolism at 3 Months|New DVT or PE at 3 months confirmed by diagnostic testing|3 months|All DVT treated patients analyzed together|||participants||95% Confidence Interval|Number
2836017|NCT00245856|Primary|Percentage of Participants That Died at 3 Months||3 months|All DVT treated patients analyzed together|||percentage of participants||95% Confidence Interval|Number
2836018|NCT00245765|Secondary|Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis||During the 12-week Treatment Period|Intention-To-Treat (ITT) population consisting of all randomized subjects.|||days||Full Range|Median
2836019|NCT00245765|Secondary|Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change."|Baseline up to Week 12|ITT population consisting of all randomized subjects. The analysis was performed for week 12 using observed case data (i.e., no imputation was performed for missing data). By week 12, there were 29 patients who had prematurely discontinued the study.|||Percent of total Body surface area||Standard Deviation|Mean
2836020|NCT00245765|Secondary|Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12|"Two methods were used for the evaluation of BSA:~The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis~The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)"|Week 12|ITT population consisting of all randomized subjects. The analysis was performed for week 12 using observed case data (i.e., no imputation was performed for missing data). By week 12, there were 29 patients who had prematurely discontinued the study.|||percentage of affected Body Surface Area||Standard Deviation|Mean
2836021|NCT00245765|Secondary|Experience of a Rebound Effect Within 2 Months After Stopping Therapy|Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy.|Within 2 months of stopping therapy|Intention-To-Treat (ITT) population consisting of all randomized subjects.|||percentage of subjects|||Number
2836022|NCT00245765|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %."|Week 12|Intention-To-Treat (ITT) population consisting of all randomized subjects.|||percentage of subjects|||Number
2836072|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function|"The domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from always to never is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836023|NCT00245765|Secondary|Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %."|Week 12|Intention-To-Treat (ITT) population consisting of all randomized subjects.|||percentage of subjects|||Number
2836024|NCT00245765|Secondary|Time to Relapse|Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).|During the 12-weeks Treatment Period|Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable.|||weeks||95% Confidence Interval|Median
2836025|NCT00245765|Secondary|Time to Psoriasis Activity and Severity Index 75 (PASI75)|"Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period.~This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12)."|During the 12-weeks Treatment Period|Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable.|||days||95% Confidence Interval|Median
2836026|NCT00245765|Secondary|Time to Psoriasis Activity and Severity Index 50 (PASI50)|"Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period.~This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12)."|During the 12-weeks Treatment Period|Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable.|||days||95% Confidence Interval|Median
2836027|NCT00245765|Primary|Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12|"The overall severity of the disease was evaluated using the following 6-point scale:~5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema~1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)"|Week 12|Intention-To-Treat (ITT) population consisting of all randomized subjects.|||percentage of subjects|||Number
2836028|NCT00245765|Primary|Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12|"Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.~PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %."|Week 12|Intention-To-Treat (ITT) population consisting of all randomized subjects.|||percentage of subjects|||Number
2836029|NCT00245635|Primary|Change in Total Score on the BDD-Y-BOCS Scale|To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.|Baseline compared to the study endpoint (week 12) [two time points]||||units on a scale||Standard Deviation|Mean
2836030|NCT00245583|Secondary|The Hamilton Anxiety Rating Scale|Hamilton Anxiety Rating Scale (HARS) - It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Higher score indicates more symptoms.|baseline and week 14|those who returned for week 14 visit included in data results|||score on a scale||Standard Deviation|Mean
2836031|NCT00245583|Secondary|Montgomery-Asberg Depression Rating Scale|"The Montgomery-Åsberg Depression Rating Scale (MADRS) is a psychological questionnaire used by clinicians to assess the severity of depression among patients who have a diagnosis of depression.~The MADRS depression test includes 10 items and uses a 0 to 6 severity scale. Total score from 0-60. Higher scores indicate increasing depressive symptoms."|baseline and week 14|those who returned for week 14 visit included in data results|||score on a scale||Standard Deviation|Mean
2836032|NCT00245583|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is an 11-item scale used to assess the severity of mania and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. YMRS total score varies between zero and 60, with higher score indicating more symptoms. A score of <= 12 indicates remission of symptoms.|baseline and week 14|those who returned for week 14 visit included in data results|||score on a scale||Standard Deviation|Mean
2836033|NCT00245583|Secondary|Barratt Impulsiveness Scale-11|"The Barratt Impulsiveness Scale (BIS-11) is a questionnaire designed to assess the personality/behavioral construct of impulsiveness, composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Subscale attentional score 8-32, subscale motor score 11-44, subscale nonplanning score 11-44, with higher scores for each subscale indicating worse outcomes. Total score from 30-120, with higher score indicating more impulsive symptoms. Items are scored on a 4-point scale:~Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4 Total scores of 72+ = high impulsiveness Total scores between 52 and 71 = within normal limits for impulsiveness Total scores lower than 52 are representative of an individual that is either extremely over-controlled or who has not honestly completed the questionnaire"|week 14||||score on a scale||Standard Deviation|Mean
2836073|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido|"The domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from always to never is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836034|NCT00245583|Secondary|Barratt Impulsiveness Scale-11|"The Barratt Impulsiveness Scale (BIS-11) is a questionnaire designed to assess the personality/behavioral construct of impulsiveness, composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Subscale attentional score 8-32, subscale motor score 11-44, subscale nonplanning score 11-44, with higher scores for each subscale indicating worse outcomes. Total score from 30-120, with higher score indicating more impulsive symptoms. Items are scored on a 4-point scale:~Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4 Total scores of 72+ = high impulsiveness Total scores between 52 and 71 = within normal limits for impulsiveness Total scores lower than 52 are representative of an individual that is either extremely over-controlled or who has not honestly completed the questionnaire"|baseline||||score on a scale||Standard Deviation|Mean
2836035|NCT00245583|Secondary|Gambling-Symptom Assessment Scale Total Score|The Gambling-Symptom Assessment Scale (G-SAS) is a 12-item self-rated measure that is designed to assess gambling symptom severity and change during treatment. Each item is scored on a 4 point scale from 0-4 with 0 meaning no symptoms and 4 meaning extreme symptoms. The total score is 0 - 48, with higher score indicating more gambling problem. Scores 7 and lower are considered normal behavior, 8-20 are considered a mild gambling problem, 21-30 are considered a moderate gambling problem, 31-40 are considered a severe gambling problem and 40-48 are considered an extreme gambling problem.|baseline and 14 weeks|those who returned for week 14 visit included in data results|||score on a scale||Standard Deviation|Mean
2836036|NCT00245583|Primary|Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)|The obsessions subscale of the Yale-Brown Obsessive Compulsive Scale modified for PG (PG-YBOCS) measures the severity and change in severity of PG symptoms such as thoughts/urges and behaviors and has been shown to be reliable and valid and correlate with global severity and South Oaks Gambling Screen scores. The scale is a clinician-rated, each item rated from 0 (no symptoms) to 4 (extreme symptoms), Each component, Obsession and Compulsion, score ranges from 0-20, yielding a total possible score range from 0 to 40, with higher score indicating more symptoms.|14 weeks||||score on a scale||Standard Deviation|Mean
2836037|NCT00245583|Primary|Obsession Component of the Yale-Brown Obsessive-Compulsive Scale for Pathological Gambling (PG-YBOCS)|The obsessions subscale of the Yale-Brown Obsessive Compulsive Scale modified for PG (PG-YBOCS) measures the severity and change in severity of PG symptoms such as thoughts/urges and behaviors and has been shown to be reliable and valid and correlate with global severity and South Oaks Gambling Screen scores. The scale is a clinician-rated, each item rated from 0 (no symptoms) to 4 (extreme symptoms), Each component, Obsession and Compulsion, score ranges from 0-20, yielding a total possible score range from 0 to 40, with higher score indicating more symptoms.|Baseline||||score on a scale||Standard Deviation|Mean
2836038|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2836039|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose|"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2836040|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2836041|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||Percent * minutes||Standard Deviation|Mean
2836042|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||Percent * minutes||Standard Deviation|Mean
2836043|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|"The measure included only the area below the pre-exercise~baseline"|0-60 minutes after the exercise challenge at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||Percent * minutes||Standard Deviation|Mean
2836058|NCT00245518|Primary|Physical Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836044|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change from Baseline||Standard Deviation|Mean
2836045|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change from Baseline||Standard Deviation|Mean
2836046|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2836047|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose||0-90 minutes after the exercise challenge performed at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2836048|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2836049|NCT00245570|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change from Baseline||Standard Deviation|Mean
2836050|NCT00245557|Primary|Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)|"The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index.~beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)"|at week 0 for both control and depressed, and at week 12 for depressed||||Spectroscopic Index||Standard Error|Least Squares Mean
2836051|NCT00245557|Primary|Geriatric Depression Scale|This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).|baseline at study entry week 0|Not all subjects included in MRS analysis had baseline GDS data.|||Units on a scale||Standard Deviation|Mean
2836052|NCT00245557|Primary|HAM-D 17 (Hamilton Depression Rating Scale)|"This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.~Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms)."|baseline at study entry week 0||||Units on a scale||Standard Deviation|Mean
2836053|NCT00245518|Primary|Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836054|NCT00245518|Primary|Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836055|NCT00245518|Primary|Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836056|NCT00245518|Primary|General Health Perceptions as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836109|NCT00245011|Secondary|Predictive Value of Imaging Studies||At Time of Tumor Resection|The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported.||||||
2836059|NCT00245518|Primary|Fatigue as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836060|NCT00245518|Primary|Physical Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836061|NCT00245518|Primary|Mental Health as Assessed by the Short Form 36 Questionnaire|The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836062|NCT00245518|Primary|Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)|Hot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836063|NCT00245518|Primary|Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836064|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836065|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836066|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836067|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836068|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836069|NCT00245518|Primary|Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score|IIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836070|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification|"The domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from always to never to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836071|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal|"The domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from always to never to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836110|NCT00245011|Primary|Tumor Response|WHO (World Health Organization) tumor measurement criteria used to determine response.|1 week after study treatment|11 subjects, heavily treated with chemotherapy with osteosarcoma metastatic to bone were enrolled; 10 evaluable for response.|||participants|||Number
2836074|NCT00245518|Primary|Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score|"The WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from always to never is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836075|NCT00245518|Primary|Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall|"The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:~Correct Image: placed properly (2 points), placed poorly (1 point)~Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point~Absent or not recognizable: 0 points~Scale ranges 0-36, with 36 representing maximum cognition ."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836076|NCT00245518|Primary|Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall|"The test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points:~Correct Image: placed properly (2 points), placed poorly (1 point)~Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point~Absent or not recognizable: 0 points~Scale ranges 0-36. with 36 being greatest cognitive function."|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836077|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops|The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks||||number of times peg dropped||Standard Deviation|Mean
2836078|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops|The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks||||number of times peg dropped||Standard Deviation|Mean
2836079|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)|The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.|baseline, 6 weeks, 12 weeks||||time in seconds||Standard Deviation|Mean
2836080|NCT00245518|Primary|Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)|The GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.|baseline, 6 weeks, 12 weeks||||time in seconds||Standard Deviation|Mean
2836081|NCT00245518|Primary|Cognitive Function as Assessed by the F-A-S Test|The F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)|baseline, 6 weeks, 12 weeks||||seconds||Standard Deviation|Mean
2836082|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836801|NCT00234286|Secondary|Individuals With an Advance Directive|Presence of advance directive based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836083|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836084|NCT00245518|Primary|Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score|The test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, & 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836085|NCT00245518|Primary|Cognitive Function as Assessed by the National Adult Reading Test (NART)|the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.|baseline, 6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2836086|NCT00245466|Secondary|Serum Levels of Testosterone After 1, 2, and 3 Years||3 years||||nanogram per milliliter||Full Range|Median
2836087|NCT00245466|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).|||participants|||Number
2836088|NCT00245466|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.|||participants|||Number
2836089|NCT00245219|Primary|Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.|Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.|||units on a scale||Standard Deviation|Mean
2836090|NCT00245219|Primary|Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.|||units on a scale||Standard Deviation|Mean
2836091|NCT00245219|Primary|Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.|||units on a scale||Standard Deviation|Mean
2836092|NCT00245128|Secondary|Reduction in Marrow Fibrosis and Decrease in Spleen Size||After 6 and 12 months of therapy|||||||
2836093|NCT00245128|Primary|Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy|"A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks.~Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period."|At 3,6, and 12 months of therapy||||percentage of participants|||Number
2836094|NCT00245102|Primary|Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST|A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.|Up to 4 weeks||||participants|||Number
2836095|NCT00245063|Primary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 weeks||||percentage of responding patients|||Number
2836096|NCT00245050|Secondary|Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)|QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL.|After Cycle 3 of chemotherapy (on average at 3 months)||||Total scores on FACT-G scale||Standard Deviation|Mean
2836097|NCT00245050|Primary|Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)|Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.|Patients were evaluable for PPE/HFS(Hand-Foot Syndrome) incidence and toxicity assessment if they received at least one course of chemotherapy. Intention to treat analysis was used.|||participants|||Number
2836098|NCT00245037|Secondary|Chronic Graft-Versus-Host Disease (cGVHD) Outcome|"Grading of Chronic GVHD:~Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD~Extensive:~One or more of the following:~Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ~Chronic GVHD Severity:~Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy.~Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy.~Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy"|Years 1, 2 and 3|This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD.|||percentage of analyzed participants|||Number
2836099|NCT00245037|Secondary|Acute Graft-Versus-Host Disease (aGVHD) Outcome|"Grading of Acute GVHD:~Severity of Individual Organ Involvement:~Skin~1 a maculopapular eruption involving less than 25% of the body surface~2 a maculopapular eruption involving 25-50% of the body surface~3 generalized erythroderma~4 generalized erythroderma with bullous formation and/or with desquamation Liver~1 bilirubin 2.0-3.0mg/100mL~2 bilirubin 3-5.9mg/100mL~3 bilirubin 6-14.9mg/100mL~4 bilirubin >15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea~1 <1000mL of liquid stool/day~2 >1,000mL of stool/day~3 >1,500mL of stool/day~4 2,000mL of stool/day, severe abdominal pain, with or without ileus~Severity of GVHD:~Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver"|Day 100, Month 6|This is cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients.|||percentage of analyzed participants|||Number
2836100|NCT00245037|Secondary|Relapse Mortality|The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate.|Years 1 and 2||||percentage of analyzed participants|||Number
2836101|NCT00245037|Secondary|Progression-Free Survival|"The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5.~Definition of Disease Progression:~MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%.~CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells.~AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate.~CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis.~MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence."|Years 1, 2, 3, and 5||||percentage of analyzed participants|||Number
2836102|NCT00245037|Secondary|Overall Survival|The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5.|Years 1, 2, 3 and 5||||percentage of analyzed participants|||Number
2836103|NCT00245037|Primary|Non-relapse Mortality|Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease.|Two years post-transplant||||Participants|||Count of Participants
2836104|NCT00245037|Primary|Regimen-Related Toxicities|Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.|5 years post-transplant||||Toxicities|||Number
2836105|NCT00245011|Secondary|Correlative Dose of Radiation by Low Dose and High Dose Samarium-153||completion of treatment|The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported||||||
2836106|NCT00245011|Secondary|Long Term Side Effects of Infusional Samarium-153 After Study Treatment||Continual|The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and is not available to be reported||||||
2836107|NCT00245011|Secondary|Toxicity at End of Study Treatment||Continual and at End of Study||||Participants|||Count of Participants
2836108|NCT00245011|Secondary|Overall and Progression-free Survival After Study Treatment||up to 4 years||||days||Full Range|Median
2836112|NCT00244985|Secondary|Progression Free Survival (PFS) Rate at 2 Years|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.|2 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2836113|NCT00244985|Secondary|Overall Response Rate (Complete and Partial Responses) at 20 Weeks|Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 before therapy. Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.|20 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2836114|NCT00244985|Secondary|Partial Response Rate at 20 Weeks|Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.|20 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2836115|NCT00244985|Primary|Complete Response Rate at 20 Weeks|Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.|20 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2836116|NCT00244933|Secondary|In Vivo Effects of Genistein in Breast Cancer Tissue Biomarkers (Ki67, TUNEL Assay, p-Akt, NF-kB, Immunohistochemistry and cDNA Microarray Analysis)||At baseline (pre-genistein treatment) and 7 days following genistein treatment|||||||
2836117|NCT00244933|Secondary|Correlate Responses With Plasma Genistein Levels||At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose)|||||||
2836118|NCT00244933|Secondary|Qualitative and Quantitative Toxicities||30 days following treatment|||||||
2836119|NCT00244933|Secondary|Duration of Survival||At 1 year following study treatment|||||||
2836120|NCT00244933|Secondary|Time to Disease Progression||From the time that treatment is initiated until the time restaging indicates progressive disease.|||||||
2836121|NCT00244933|Secondary|Overall Survival||From the time the last patient comes off study treatment for one year to monitor survival|||||||
2836122|NCT00244933|Secondary|Duration of Response||From the time the last patient comes off study treatment for one year|||||||
2836123|NCT00244933|Primary|Objective Response Rate by RECIST Criteria Following|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 2 courses until disease progression or death, up to 24 weeks||||participants|||Number
2836124|NCT00244881|Secondary|Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD||12 weeks||||percentage of participants|||Number
2836125|NCT00244881|Primary|Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria|RECIST 1.0 Criteria|Up to 7 years||||percentage of participants||95% Confidence Interval|Number
2836126|NCT00244881|Primary|Fraction of Patients With Increased Levels of Circulating Endothelial Cells|An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).|After 3 weeks of treatment||||percentage of participants|||Number
2836127|NCT00244855|Secondary|Survival|Percentage of patients remaining alive estimated according to the Kaplan-Meier method|At 6 months, 12 months and 24 months after enrollment||||Kaplan-Meier estimated % of patients||95% Confidence Interval|Number
2836128|NCT00244855|Primary|Progression-free Survival|Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method|At 3 and 6 months after enrollment||||Kaplan-Meier estimated % of patients||95% Confidence Interval|Number
2836129|NCT00244764|Secondary|Progression-free Survival|Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a >=20% increase in target lesions.|From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)|All Enrolled Population. Participants who did not progress or die were censored at their last radiologic assessment.|||weeks||95% Confidence Interval|Median
2836130|NCT00244764|Secondary|Duration of Response|Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.|First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All participants in the Enrolled Population who had a CR or PR|||weeks||95% Confidence Interval|Median
2836220|NCT00243919|Primary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|12 months post-stroke|Intention to treat analysis. Missing data were imputed using the LOCF method.|||percent of participants|||Number
2836131|NCT00244764|Primary|Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants|The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.|Week 12|Subset of the All Enrolled Population including only the first 60 participants|||participants|||Number
2836132|NCT00244764|Primary|Overall Response by RECIST Criteria|The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.|Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All Enrolled: all participants who received at least one dose of pazopanib|||participants|||Number
2836133|NCT00244751|Secondary|GI262570 Serum Concentrations on Week 2, 16, 28, 40, and Week 52|Samples for Week 2 serial group were planned to be collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. For Weeks 16 and 40 samples were planned to be collected at 0 (pre-morning dose)1 and between 1.5-6 hour post-morning dose 2. For Weeks 28 and 52 samples were planned to be collected at 0 (pre-morning dose)1 and between 6-10 hour post-morning dose 2.|Weeks 2, 16, 28, 40 and 52|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing. Data was not collected for this endpoint.||||||
2836134|NCT00244751|Secondary|Volume of Distribution Expressed as a Function of Bioavailability (V/F) of GI262570|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||milliliter||Geometric Coefficient of Variation|Geometric Mean
2836135|NCT00244751|Secondary|Terminal Elimination Half-life (T1/2), Time to First Quantifiable Concentration (Tlag) and Time to Cmax (Tmax) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||hour||Full Range|Median
2836136|NCT00244751|Secondary|DN Cmax of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Nanograms per milliliter per mg||Geometric Coefficient of Variation|Geometric Mean
2836137|NCT00244751|Secondary|Maximum Observed Concentration (Cmax), Minimum Observed Concentration (Cmin) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2836138|NCT00244751|Secondary|Apparent Clearance Following Oral Dosing (CL/F) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||milliliter per hour||Geometric Coefficient of Variation|Geometric Mean
2836139|NCT00244751|Secondary|Dose Normalized (DN) AUC (0-tau) of GI262570 on Week 2|Sample s for Week 2 serial group were collected at 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|PK parameter Population. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Hours nanograms per milliliter per mg||Geometric Coefficient of Variation|Geometric Mean
2836183|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
2836140|NCT00244751|Secondary|Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length 'Tau' (AUC [0-tau]) of GI262570 on Week 2|Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.|At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2|The Pharmacokinetic (PK) Parameter Population included all participants in the subset having the serial PK profiles performed at Week 2 and having sufficient data for the calculation of the PK parameters. Initially the doses selected were twice daily, but after implementation of Amendment 4 the dose regimen was reduced to half the original dosing.|||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2836141|NCT00244751|Secondary|Median Change From Baseline in Serum HCV RNA Levels Over Time|Serum for HCV RNA levels were collected at pre-screen, Baseline, Week 28, Week 52, and at the 4 week follow up visit. Value at Day 1 visit (day of first dose) was considered as Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|MITT Population. Only those participants available at the specified time points were analyzed.|||Log10 International unit per milliliter||Full Range|Median
2836142|NCT00244751|Secondary|Mean Change From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 52|Value at Day 1 visit (day of first dose) was considered as Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|MITT Population. Only those participants with data available at the indicated time point were analyzed.|||Log10 International unit per milliliter||Standard Deviation|Mean
2836143|NCT00244751|Secondary|Median Change From Baseline in Serum ALT Over Time|ALT was assessed as per upper limit of normal where the normal range was 0-48 international units per liter. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|MITT Population. Only those participants available at the specified time points were analyzed.|||Per upper limit normal||Full Range|Median
2836144|NCT00244751|Secondary|Mean Change From Baseline in Measures of Insulin Resistance|Insulin resistance was measured using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Belfiore Insulin Sensitivity Index (ISI) and Quantitative Insulin Sensitivity Check Index (QUICKI). HOMA-IR = fasting plasma insulin*fasting plasma glucose / 22.5 and ISI = 2 / [(fasting plasma glucose from the participant / fasting plasma glucose normal reference range)*( fasting plasma insulin from the participant / fasting plasma insulin normal reference range) + 1] and QUICKI = 1/(log[fasting plasma Insulin] + log[fasting plasma glucose]). Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|As Treated Population. Only those participants with data available at the indicated time point were analyzed.|||Units on a scale||Standard Deviation|Mean
2836145|NCT00244751|Secondary|Mean Change From Baseline in Serum ALT Levels|ALT was assessed as per upper limit of normal where the normal range was 0-48 international units per liter. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|MITT Population. Only those participants with data available at the indicated time points were analyzed.|||Per upper limit normal||Standard Deviation|Mean
2836146|NCT00244751|Secondary|Mean Change From Baseline in Serum FibroSure (FibroTest/ActiTest) Score at Week 52|FibroTest was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase. FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis. Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase. ActiTest was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis. Day 1 value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and Week 52|MITT Population. Only those participants with data available at the indicated time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2836147|NCT00244751|Secondary|Mean Change From Screening in Metavir Scores at Week 52|Metavir activity score ranged from 0 to 3 (higher score indicates severe symptoms of necrosis). 0: Piecemeal necrosis (PMN) absent and lobular necrosis (LN) absent or slight, 1: PMN slight and LN moderate, 2: PMN moderate and LN severe, 3: PMN severe. Metavir fibrosis score ranged from 0 to 4 (higher score indicates severe symptoms of necrosis). 0: No fibrosis, 1: Portal fibrosis without septa, 2: Portal fibrosis with septa, 3: Septal fibrosis without cirrhosis, 4: Cirrhosis. Change from screening was calculated as the post screening assessment minus the screening assessment for a given parameter.|Screening and Week 52|MITT Population. Only those participants available at the specified time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2836157|NCT00244751|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to 4 weeks post treatment (52 weeks)|As Treated Population consisted of all participants for whom no clear evidence was available of failure to take study medication.|||Participants|||Count of Participants
2836148|NCT00244751|Secondary|Mean Change From Screening in Total Ishak Score (Necroinflammatory Score and Fibrosis Score) at Week 52|Ishak score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The necroinflammatory score is the combined score for necrosis and inflammation domains and ranged from 0 (best) to 14 (worst). Change from screening was calculated as the post screening assessment minus the screening assessment for a given parameter.|Screening and Week 52|MITT Population. Only those participants available at the specified time point were analyzed|||Scores on a scale||Standard Deviation|Mean
2836149|NCT00244751|Secondary|Number of Participants Whose Ishak Fibrosis Score Remains Unchanged at Week 52|No change was defined as having the same score at both Baseline and at Week 52. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.|Week 52|MITT Population.|||Participants|||Count of Participants
2836150|NCT00244751|Secondary|Number of Participants Regressing at Least 1 Point on the Ishak Fibrosis Score at Week 52|Regression was defined as a decrease by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.|Week 52|MITT Population.|||Participants|||Count of Participants
2836151|NCT00244751|Secondary|Number of Participants Progressing at Least 1 Point on the Ishak Fibrosis Score at Week 52|Progression was defined as an increase by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.|Week 52|MITT Population.|||Participants|||Count of Participants
2836152|NCT00244751|Primary|Number of Participants With Fluid Retention Events|Fluid retention event was one of the AEs reported. AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 4 weeks post-treatment (52 weeks)|As Treated Population.|||Participants|||Count of Participants
2836153|NCT00244751|Primary|Mean Change From Baseline in Heart Rate|Heart rate assessment were done at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to be missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|As treated population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
2836154|NCT00244751|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSP)|SBP and DBP readings were taken at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.|Baseline and up to 4 weeks post-treatment (52 weeks)|As Treated Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury||Standard Deviation|Mean
2836155|NCT00244751|Primary|Number of Participants With Change in Toxicities Grades 3 and 4 of Laboratory Parameters Over Time|Clinical laboratory parameters: Alkaline phosphatase, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Total bilirubin, Cholesterol, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Glucose, Hemoglobin, Potassium, Low density lipid (LDL) cholesterol, Lymphocytes, Sodium, Segmented neutrophils, Platelet count, White blood cell (WBC) count were assessed for change in grade toxicities. Toxicities were graded as grade 1 to grade 4 in increasing order of severity of toxicity. Thus grade 4 indicating severe toxicity. Only those parameters with grade 3 and 4 toxicities are presented.|Up to 4 weeks post-treatment (52 weeks)|As Treated Population. Only those participants available at the specified time points for particular parameter were analyzed.|||Participants|||Count of Participants
2836156|NCT00244751|Primary|Number of Participants With Abnormal ECG Findings|A standardized 12-lead ECGs were recorded at pre-screening, and pre-dose, at Baseline/Day 1, Weeks 16, 34, and 52 or withdrawal and at the 4 week follow-up visit. Any conditions such as bundle branch block, repolarization, depolarization, abnormal sinus rhythms, atrial fibrillation etc. are considered to be clinically abnormal findings.|Up to 4 weeks post-treatment (52 weeks)|As Treated Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2836184|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.|||percentage of participants|||Number
2836158|NCT00244751|Primary|Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52|In ranked assessment (fibrosis and necroinflammation), available slides from each participant were evaluated as to whether one slide presents a globally more benign histopathology or whether the matched slides comprise globally equivalent histologic patterns. Subsequent data analysis revealed whether slides scored (within matched pairs of slides) as more benign occurred in different proportions of the Week 52 liver biopsies, according to treatment group. The number of participants with paired biopsies was based on the number with a Rank Assessment.|Week 52|MITT Population. Only those participants with paired biopsies at the indicated time point were analyzed.|||Participants|||Count of Participants
2836159|NCT00244751|Primary|Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis|A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. Morphometric analysis was performed using specimens stained with Sirius red and computerized image analysis. Sirius red was used to stain extracellular collagen in liver sections. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.|Baseline and at Week 52|MITT Population. Only those participants with data available at the indicated time point were analyzed.|||Ratio of positive area||Standard Deviation|Mean
2836160|NCT00244751|Primary|Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52|A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. The immunohistochemical marker assessed was smooth muscle alpha-actin (aSMA). Sections of the liver biopsies were stained by standard immunocytochemical techniques using a monoclonal antibody to smooth muscle actin with 'very intense purple' as the detection chromogen. This gives a reddish-purple color to the activated stellate cells, which strongly contrasts with the rest of the tissue. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.|Baseline and Week 52|Modified Intent to Treat (MITT) Population consisted of all participants with chronic hepatitis C randomized, regardless of whether or not the study drug was actually taken or if the participant completed the planned duration of the study. Only those participants with data available at the indicated time points were analyzed.|||Ratio of positive area||Standard Deviation|Mean
2836161|NCT00244725|Secondary|Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment|The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported.|Up to 12 days|ITT population. Number of participants were available at the time of analysis were included.|||Percentage of participants||95% Confidence Interval|Number
2836162|NCT00244725|Secondary|Percentage of Participants With Total VTE Any Time After Start of Treatment|Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported.|Up to Visit 9 (Day 28 post treatment)|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis|||Percenatge of participants||95% Confidence Interval|Number
2836163|NCT00244725|Secondary|Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment|A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were efficacy evaluable or reported a major bleed or VTE by the time of early withdrawal were used for the analysis|||Percentage of participants||95% Confidence Interval|Number
2836164|NCT00244725|Secondary|Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment|A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria.|Up to 12 days|ITT Population. The participants from ITT population who completed study treatment (Day-10 visit) or reported a major bleed by the time of early withdrawal were used for the analysis|||Percentage of participants||95% Confidence Interval|Number
2836221|NCT00243841|Secondary|Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events|Number of unique patients who had grade 3 or 4 adverse events that were possibly, probably or definitely related to study treatment.|up to 4 years|All patients who received treatment|||Participants|||Count of Participants
2836165|NCT00244725|Secondary|Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up|In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported.|Up to 68 days|ITT population.|||Microgram per millilitre (mcg/ml)||Standard Deviation|Geometric Mean
2836166|NCT00244725|Secondary|Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment|A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Perentage of participants||95% Confidence Interval|Number
2836167|NCT00244725|Secondary|Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment|A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2836168|NCT00244725|Secondary|Number of Death Due to VTE Over 10 ± 2 Days of Treatment|A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as 'Fatal PE'. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator's death classification was recorded as 'Fatal PE'. Number of death due to VTE over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Participants|||Number
2836169|NCT00244725|Secondary|Percentage of Participants With PE Over 10 ± 2 Days of Treatment|Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question 'Was a PE identified?' was 'Yes'. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2836170|NCT00244725|Secondary|Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment|A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of paticipants||95% Confidence Interval|Number
2836171|NCT00244725|Secondary|Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment|Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions 'Left proximal' and 'Right proximal' was 'DVT'. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported.|Up to 12 days|ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis.|||Percentage of participants||95% Confidence Interval|Number
2836802|NCT00234286|Secondary|Individuals With Pastoral Care Visit|Pastoral Care Visit based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836172|NCT00244725|Primary|Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment|Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.|Up to Visit 7 (10 ± 2 days of treatment)|ITT population comprised of all participants who were randomized and received at least one dose of study treatment. Total number of participants with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at study completion were used for analysis.|||Percentage of participants||95% Confidence Interval|Number
2836173|NCT00244712|Secondary|Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction|The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.|Baseline through 96 weeks|The Safety population which included all randomized participants who received at least one dose of study medication.|||participants|||Number
2836174|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.|||participants|||Number
2836175|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations|||participants|||Number
2836176|NCT00244712|Secondary|Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96|The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.|Baseline to Week 96|The Intent-To-Treat-Exposed (ITT-E) population|||participants|||Number
2836177|NCT00244712|Secondary|Median Change From Baseline in CD4+ Cells at Weeks 48 and 96|A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.|||cells per cmm||Full Range|Median
2836178|NCT00244712|Secondary|Median Change From Baseline in HIV-1 RNA at Week 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.|||log10 copies/mL||Full Range|Median
2836179|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
2836180|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
2836181|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
2836182|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F|||percentage of participants|||Number
2836803|NCT00234286|Secondary|Sublingual Administration|Sublingual administration of medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836185|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.|||percentage of participants|||Number
2836186|NCT00244712|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA >=50 copies/mL.|||percentage of participants|||Number
2836187|NCT00244621|Secondary|Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28||||Percent change||Inter-Quartile Range|Median
2836188|NCT00244621|Secondary|Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28||||Percent change||Inter-Quartile Range|Median
2836189|NCT00244621|Secondary|Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)||From randomisation to end of double-blind treatment (4 weeks)||||mm Hg||Standard Deviation|Mean
2836190|NCT00244621|Primary|Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)||From randomisation to end of double-blind treatment (4 weeks)||||mm Hg||Standard Deviation|Mean
2836191|NCT00244374|Secondary|HIV Vaccine Trial Knowledge|"Participants were asked if they agreed or disagreed with or were unsure of each of eight statements about HIV vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET).~Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative.~Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance).~Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies.~Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe.~Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies.~HIV vaccines will never affect a person's HIV test results.~An HIV vaccine can infect a person with HIV disease.~People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data|||Participants|||Number
2836192|NCT00244374|Secondary|HIV Vaccine Trial Willingness|"We assessed knowledge about vaccine trials and willingness to participate in preventive HIV vaccine trials by asking the question: How willing would you be to join a study of a vaccine to prevent HIV infection, if the study were to start tomorrow?. Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing)."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data|||Participants|||Number
2836193|NCT00244374|Secondary|Viral Transmission Risk Behavior Association With Travel|In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel in the 3 months prior to baseline and behaviors occurring in the 30 days prior to baseline, such as drug and alcohol and sexual behaviors, that may facilitate the spread of viral infections.|Baseline|Cross-sectional analysis of 355 subjects enrolled between 2004 and 2006|||percentage of participants|||Number
2836194|NCT00244374|Secondary|Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses|To examine the effect of hepatitis C virus (HCV) infection on vaccine effectiveness, we compared anti-HBs (antibody to the hepatitis B surface antigen) seroconversion after three vaccine doses between anti-HCV (antibody to the hepatitis C virus) positive and anti-HCV negative participants.|12 months|139 participants who completed 3 vaccine doses were included in the analysis. Enrollment for this aim continued after enrollment into the 12-month vaccine adherence trial closed; an additional 51 persons were found eligible and enrolled.|||Participants|||Number
2836195|NCT00244374|Primary|Vaccine Series Completion|The primary outcome was the completion of the four-dose vaccine series in a 12 month period.|12 months||||participants|||Number
2836196|NCT00244140|Secondary|The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of diagnostic CECTs|||Number
2836197|NCT00244140|Secondary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of participants in QOI grade|||Number
2836198|NCT00244140|Secondary|The Ability of the Investigator to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the investigators.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of diagnostic CECTs|||Number
2836222|NCT00243841|Secondary|Overall Survival|Kaplan-Meier Analysis will be used to calculate the median and 95% CI for overall survival. This will be calculated from the time of treatment until death. If a patient did not die, the patient will be censored at their last known alive date.|Up to 8 years|all patients who received treatment and had a post-baseline assessment|||months||95% Confidence Interval|Median
2836199|NCT00244140|Primary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.|||Number of participants in QOI grade|||Number
2836200|NCT00244101|Secondary|Parental Questionnaire for Health Status||at 24 months of age|||||||
2836201|NCT00244101|Secondary|Days in Hospital||prior to hospital discharge|||||||
2836202|NCT00244101|Secondary|Days of Ventilator Support||prior to hospital discharge|||||||
2836203|NCT00244101|Secondary|Complications of Prematurity||prior to hospital discharge|||||||
2836204|NCT00244101|Primary|Death||36 weeks adjusted age|||||||
2836205|NCT00244101|Primary|Death or Chronic Lung Disease||at 36 weeks postmenstrual age|intention to treat analysis|||participants|||Number
2836206|NCT00244010|Primary|Treatment Failures|The primary objective of this study is to evaluate the safety of HAPLO HSCT for patients with refractory severe aplastic anemia (SAA) or refractory cytopenias. The treatment plan would be considered unsafe if we can demonstrate that it is associated with a significantly higher treatment failure rate. The treatment failure is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft failure or death due to any cause within 100 days post HSCT or after the last cellular product infusion, if required.|100 days post transplant|Enrollment was terminated due to the PI leaving the institution. Insufficient data was generated to answer the objective.||||||
2836207|NCT00243932|Primary|Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score.|The ALSFRSr, a questionnaire-based scale assessing daily living function ranging from 48 (best score) to 0 (worst), was administered to the patient, or to a proxy if the patient could not communicate effectively. Decline was defined as ALSFRSr at baseline minus ALSFRSr at month 9. Thus a positive value indicates worsening.|9 months||||units on a scale||Standard Deviation|Mean
2836208|NCT00243932|Secondary|The Change Over 9 Months in Forced Vital Capacity; Fatigue Severity Scale; Short Form-36; and 8OH2dG (a Biomarker of Oxidative Stress Measured in a Blood Sample).||9 months|||||||
2836209|NCT00243919|Secondary|Activities Specific Balance Confidence (ABC) Score|Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
2836210|NCT00243919|Secondary|Berg Balance Score|Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
2836211|NCT00243919|Secondary|Fugl-Meyer Lower Extremity Score|Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
2836212|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Mobility|Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
2836213|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)|Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
2836214|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Participation|Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL-IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities.|Baseline, 6 months and 12 months post-stroke||||units on a scale||Standard Deviation|Mean
2836215|NCT00243919|Secondary|Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day|As measured with a step activity monitor averaged over 2 days.|Baseline, 6 months and 12 months post-stroke||||steps||Inter-Quartile Range|Median
2836216|NCT00243919|Secondary|6 Minute Walking Distance (Meters)|Distance walked in 6 minutes.|Baseline, 6 months and 12 months post-stroke||||meters||Standard Deviation|Mean
2836217|NCT00243919|Secondary|6 Month Outcome: Walking Speed: Measured During a 10-meter Walk||Baseline and 6 months post-stroke||||m/sec||Standard Deviation|Mean
2836218|NCT00243919|Secondary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|Baseline and 6 months post-stroke|Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||percent of participants|||Number
2836219|NCT00243919|Primary|Walking Speed: Measured During a 10-meter Walk||Baseline and 12 months post-stroke||||m/sec||Standard Deviation|Mean
2836804|NCT00234286|Secondary|Individuals Who Received Scopolamine|Administration of scopolamine (for death rattle) based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836223|NCT00243841|Secondary|Time to In-field Failure|Kaplan-Meier Analyses will be used to calculate the median and 95% Confidence Interval for the time until in-field failure. This will be calculated from the time of treatment until the time of in-field failure. If a patient did not have in-field failure, the patient will be censored at their last evaluation date.|up to 4 yrs|All pts who received treatment and had a post-baseline assessment|||months||95% Confidence Interval|Median
2836224|NCT00243841|Primary|6 Month Local In-field Control|Percent of patients and the 95% Binomial Confidence interval who were free of in-field progression at 6 months following treatment for the patients in Phase II|6 months|All patients who received treatment and had a post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2836225|NCT00243841|Primary|Number of Patients With DLTs|Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.|6 weeks|All patients who received treatment in Phase I|||Participants|||Count of Participants
2836226|NCT00243659|Secondary|Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge|Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit five.|||patients|||Number
2836227|NCT00243659|Primary|Number of Patients Who Achieved Hemostatic Efficacy After Surgery|Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit three.|||patients|||Number
2836228|NCT00243503|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.|||ng/mL||Standard Deviation|Mean
2836229|NCT00243503|Secondary|Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.|||ng/mL||Standard Deviation|Mean
2836230|NCT00243503|Secondary|Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The Pharmacokinetic (PK) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2836231|NCT00243503|Secondary|EORTC QLQ (BR23)|BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||scores on a scale||Standard Deviation|Mean
2836232|NCT00243503|Secondary|EORTC QLQ-C30|EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||scores on a scale||Standard Deviation|Mean
2836233|NCT00243503|Secondary|Probability of Survival at One Year|One- year survival probability was estimated using the Kaplan-Meier method.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||percentage of 1-year survival||95% Confidence Interval|Number
2836234|NCT00243503|Secondary|Overall Survival (OS)|Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||months||95% Confidence Interval|Median
2836235|NCT00243503|Secondary|Time to Progression (TTP)|Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||weeks||95% Confidence Interval|Median
2836236|NCT00243503|Secondary|Progression Free Survival (PFS)|Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||Weeks||95% Confidence Interval|Median
2836343|NCT00242567|Primary|Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer|Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.|18 months|The ITT Population will consist of all patients randomized to treatment.|||participants|||Number
2836237|NCT00243503|Secondary|Percentage of Participants With Clinical Benefit|Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||Percentage of Participants||95% Confidence Interval|Number
2836238|NCT00243503|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.|From start of treatment through 18 months|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response.|||weeks||95% Confidence Interval|Median
2836239|NCT00243503|Primary|Percentage of Participants With Overall Confirmed Objective Disease Response|Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.|From start of treatment through 18 months|The intent-to-treat (ITT) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).|||percentage of participants||95% Confidence Interval|Number
2836240|NCT00243412|Secondary|Change From Baseline in Cyclic Citrullinated Peptide (CCP) Antibodies/Cytokines|Because of the different laboratory methods that were used to measure anti-CCP antibody levels, no summary statistics were calculated.|Baseline, 24 Months||||units|||Number
2836241|NCT00243412|Secondary|Change From Baseline in Rheumatoid Factor (RF)|Serum levels of rheumatoid factor at baseline, month 24 and change from baseline to month 24.|Baseline, 24 Months|Participants from the Safety-Evaluable population for whom data was available at baseline and month 24.|||IU/mL||Standard Deviation|Mean
2836242|NCT00243412|Secondary|DAS28-4 Erythrocyte Sedimentation Rate(ESR)|The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease In this trial, CRP rather than ESR was used, unless the CRP value was missing at both Day 1 and screening, in which case ESR value was used.|24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
2836243|NCT00243412|Secondary|Change From Baseline in Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F)|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
2836244|NCT00243412|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in a certified translation of the local languages at the participating sites and was scored based on the instructions from the Stanford University Medical Center.The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
2836245|NCT00243412|Secondary|Change From Baseline in Short Form 36 (SF 36) Summary and Subscale Scores|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning (PF), Role Physical (RP), Bodily Pain(BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE),Mental Health (MH). Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.|||Units on a Scale||Standard Deviation|Mean
2836246|NCT00243412|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response and Remission Using Disease Activity Score 28-4 (DAS28-4)C-reactive Protein (CRP)|"EULAR remission = DAS28-4(CRP) < 2.6 (Fransen et al. 2004.~EULAR response categories (van Gestel et al. 1999):~Good response = final DAS28-4(CRP) < 3.2 and decreased > 1.2 points from baseline Moderate response = final DAS28-4(CRP) ≥ 3.2 but ≤ 5.1 and decreased > 0.6 points from baseline or final DAS28-4(CRP) > 5.1 and decreased > 1.2 from baseline."|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Participants|||Number
2836286|NCT00243152|Secondary|Subjective Ratings of Pain During Magnetic Resonance Scanning|"Quantitative Sensory Testing (QST)~Stimuli Type: Heat, Cold, Brush Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness~Ratings on a likert scale of 0-10 with 0 being defined as no pain and 10 being defined as worst possible pain"|week 10 (during the scan)||||scores on a pain scale||Standard Deviation|Mean
2836247|NCT00243412|Secondary|Number of Participants With American College of Rheumatology (ACR) Major Clinical Response and/or Remission|"Major clinical response is an ACR70 response defined as improvement from baseline: ≥70% in tender joint count; ≥70% in swollen joint count; ≥70% in 3 of the following: Patient Pain Assessment, Patient Global Assessment, Physician Global Assessment, Patient Self-Assessed Disability, ESR or CRP for ≥169 consecutive days.~Remission: ≥5 requirements fulfilled for ≥2 consecutive months: Duration of morning stiffness <15 minutes, No fatigue, No joint pain, No joint tenderness or pain on motion, No soft tissue swelling in joints or tendon sheaths, ESR <30 mm/hour for women and <20 mm/hour for men."|24 months|Intent−to−Treat (ITT)|||Participants|||Number
2836248|NCT00243412|Secondary|Number of Participants With American College of Rheumatology Responses (ACR20, ACR50, and ACR70)|"ACR20 response was defined as satisfying the following 3 criteria improvement from baseline: ≥ 20% in tender joint count; ≥ 20% in swollen joint count; ≥ 20% improvement from baseline in 3 of the following 5 criteria:~Subject's Global Assessment of Pain Subject's Global Assessment of Disease Activity Physician's Global Assessment Subject's Self-Assessment Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) Note: The definitions of ACR50 and ACR70 are the same as ACR20, except that the 20% value in the above definition is replaced by 50% and 70% values, respectively."|Baseline, 24 months|Intent−to−Treat (ITT)|||Participants|||Number
2836249|NCT00243412|Secondary|Change From Baseline in Disease Activity Score 28-4 C-reactive Protein (DAS28-4(CRP))|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at 24 months was analyzed for DAS28-4 (CRP).|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.|||Scores on a scale||Standard Deviation|Mean
2836250|NCT00243412|Primary|Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)|"A Grade III Adverse Event (AE) is severe; defined as considerable interference with the subject's daily activities, medical intervention/therapy required and hospitalization possible.~A Grade IV AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, hospitalization probable.~Because of the small sample size and the small number of subjects who completed Week 104, the analysis were limited to descriptive statistics only."|24 months|Safety−Evaluable Population|||Participants|||Number
2836251|NCT00243386|Post-Hoc|Median (IQR) Annualized Bleed Rates|Bleed rates (number of bleeding episodes per subject) were annualized to account for the varying number of days a subject may have actually been on each regimen.|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Per-Protocol Efficacy Analysis Set|||Bleeding episodes||Inter-Quartile Range|Median
2836252|NCT00243386|Secondary|Physical Component Scores (PCS) HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) - (End of prophylaxis regimen) A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age|||Scores on a scale||Full Range|Median
2836253|NCT00243386|Secondary|Bodily Pain HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) - (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age|||Scores on a scale||Full Range|Median
2836254|NCT00243386|Primary|Median Annualized Bleed Rate Estimates From Each of the 1 Year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):~Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.~PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat|||Bleeds per year||Full Range|Median
2836255|NCT00243386|Secondary|HRQoL Scores Change From On-Demand Treatment Regimen Period Through Prophylaxis Period|"Differences in health domain scores = (End of on-demand treatment) - (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen~Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS).~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set ≥14 Years and Older|||Scores on a scale||Full Range|Median
2836256|NCT00243386|Secondary|Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS at the End of Treatment Regimens|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set|||Scores on a scale||Full Range|Median
2836439|NCT00240227|Secondary|Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.||||||
2836257|NCT00243386|Secondary|Baseline Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline|Safety Analysis Set|||Scores on a scale||Full Range|Median
2836258|NCT00243386|Secondary|Number of Participants With Severe SAEs and Severe Non-SAEs by Preferred MedDRA Term and Treatment Regimen|This outcome is focused only on SEVERE SAEs and SEVERE non-SAEs|Throughout the study period (4 years and 5 months)|Safety Analysis Set|||participants|||Number
2836259|NCT00243386|Secondary|AEs With Onset ≤1 Hour Following the End of an Infusion, Regardless of Relatedness||Throughout study period (4 years and 5 months)|Safety Analysis Set|||Events|||Number
2836260|NCT00243386|Secondary|Number of Participants With SAEs by Preferred MedDRA Term and Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set|||participants|||Number
2836261|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to IP by Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set|||participants|||Number
2836262|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to Investigational Product (IP)|Number of treated participants with 1 or more AE regardless of relatedness to IP|Throughout study period (4 years and 5 months)|Safety Analysis Set|||Participants|||Number
2836263|NCT00243386|Secondary|Number of Participants With AEs Related to Investigational Product (IP)|Number of treated participants with AEs judged to be possibly or probably related to treatment with IP|Throughout study period (4 years and 5 months)|Safety Analysis Set|||Participants|||Number
2836264|NCT00243386|Secondary|Factor VIII Inhibitor Development|Number of treated participants who developed factor VIII inhibitors|Throughout study period (4 years and 5 months)|Safety Analysis Set|||Participants|||Number
2836265|NCT00243386|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||dL/kg||Standard Deviation|Mean
2836266|NCT00243386|Secondary|Mean Residence Time|Computed as total Area Under the Moment Curve (AUMC) divided by the total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
2836267|NCT00243386|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||mL/(kg*h)||Standard Deviation|Mean
2836268|NCT00243386|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
2836269|NCT00243386|Secondary|Adjusted Incremental Recovery (IR)|"Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.~Adjusted IR defined as:~[Cmax (IU/dL) - pre-infusion FVIII (IU/dL)]/dose (IU/kg)"|30 minutes pre-infusion to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU/dL per IU/kg||Standard Deviation|Geometric Mean
2836270|NCT00243386|Secondary|Maximum Plasma Concentration (C-max)|Maximal Factor VIII Concentration After Infusion|Within 1 hour post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU/dL||Standard Deviation|Geometric Mean
2836271|NCT00243386|Secondary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU*h/dL||Standard Deviation|Geometric Mean
2836272|NCT00243386|Secondary|Total Area Under the Curve (AUC)|Total AUC estimated by AUC 0-48h plus an area extrapolated from the log-linear regression model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set|||IU*h/dL||Standard Deviation|Geometric Mean
2836273|NCT00243386|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~8 hrs after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Hemostatic Efficacy Rating Analysis Set (Participants with bleeding episodes that were rated)|||bleeding episodes|||Number
2836274|NCT00243386|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Throughout the study period (4 years and 5 months)|Intent to Treat Efficacy Set|||Bleeding episodes|||Number
2836275|NCT00243386|Secondary|Total Weight-Adjusted Dose of rAHF-PFM Used Per Year for Each Prophylaxis Arm|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):~Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.~PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat|||IU/kg||Inter-Quartile Range|Median
2836307|NCT00243022|Secondary|Overall Survival: Percentage of Patients That Were Alive at 1 Year|Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.|1 year.|All 12 patients followed to death or censored at last visit when known alive|||percentage of particpants||95% Confidence Interval|Number
2845782|NCT00113425|Secondary|Change From Baseline in Papule Acne Lesions at Week 16||Baseline and Week 16||||papule acne lesions||95% Confidence Interval|Mean
2836276|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Any Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X' = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Any Prophylaxis Treatment TABR).~Any Prophylaxis = Standard or PK-Driven Prophylaxis~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Intent to treat|||(bleeds/year)^(1/2)||Standard Deviation|Mean
2836277|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and PK-Driven Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X' = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (PK-Driven Prophylaxis Treatment TABR)~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat|||(bleeds/year)^(1/2)||Standard Deviation|Mean
2836278|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Standard Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X' = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Standard Prophylaxis Treatment TABR).~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat|||(bleeds/year)^(1/2)||Standard Deviation|Mean
2836279|NCT00243386|Primary|Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Study Part 2):~Standard prophylaxis (20-40 IU/kg (every 48 ±6 hour), exact regimen determined by investigator)~PK-driven prophylaxis (20-80 IU/kg (every 72 ±6 hour), exact regimen determined by sponsor)~Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X = bleeds/year), X' = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test."|12 months ±2 weeks|Per Protocol|||(bleeds/year)^(1/2)||Standard Deviation|Mean
2836280|NCT00243347|Secondary|Change From Baseline in Mean Arterial Blood Pressure (MAP)|Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.|||mmHg||95% Confidence Interval|Mean
2836281|NCT00243347|Primary|Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)|Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.|||Percentage change in SUVmax||95% Confidence Interval|Geometric Mean
2836282|NCT00243269|Secondary|Health Related Quality of Life|Health-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale - General (FACT-G). The FACT-G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.|5 days||||Units on scale||Standard Deviation|Mean
2836283|NCT00243269|Primary|Five-day Nausea Diary|"Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = Not at all nauseated and at the other end by 7 = Extremely nauseated. The description Moderately nauseated was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods."|Five days|All patients who did not have protocol violations who provided evaluable data were included in the analyses. No data imputation was used.|||Units on scale||Standard Deviation|Mean
2836284|NCT00243243|Primary|Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively||24 hours||||units of blood components|||Number
2836285|NCT00243191|Primary|To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.|To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.|Prior to and after 2-weeks of imatinib therapy|Population of paired tissue samples collected from patients with confirmed diagnosis of dermatofibrosarcoma protuberans. Tissue sample will be considered evaluable if there is adequate pre-treatment and on-treatment tumor tissue available for the proposed molecular studies, and resection of DFSP was completed after receiving imatinib.|||paired tumor tissue samples|||Number
2847537|NCT00100698|Secondary|Change in Body Mass Index|Change in body mass index|18 months||||kilogram/meters squared||Standard Error|Mean
2836287|NCT00243152|Primary|Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States|fMRI scans acquired Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness fMRI scans acquired Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** fMRI scans acquired Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** Cortical, subcortical, and brain stem sensory regions Z-scores Increase or decrease in activation as affected by the drug|Week 10 during scanning session|The data's primary comparisons no longer exists per intervention.|||Z-statistic|||Number
2836288|NCT00243074|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of protocol treatment with AZD2171 (cediranib maleate)|||Participants|||Number
2836289|NCT00243074|Secondary|Adverse Event Rates|Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.|Daily during protocol treatment|All patients who received protocol treatment were assessed for adverse events. See adverse event tables for specific details.|||Participants|||Count of Participants
2836290|NCT00243074|Secondary|Objective Response Rate Per Modified RECIST for Pleural Tumors|The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.|Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171|||percentage of participants||95% Confidence Interval|Number
2836291|NCT00243074|Secondary|Disease Control Rate|The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.|Every 8 weeks until disease progression progression, up to 5 years.|Eligible patients who received AZD2171|||percentage of participants||95% Confidence Interval|Number
2836292|NCT00243074|Secondary|Progression-free Survival|From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 8 weeks until disease progression or death, up to 5 years.|Eligible patients who received AZD2171|||months||95% Confidence Interval|Median
2836293|NCT00243074|Secondary|Overall Survival|From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.|Eligible patients who received AZD2171|||months||95% Confidence Interval|Median
2836294|NCT00243074|Primary|Overall Response Rate|"confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.."|Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171|||percentage of participants||95% Confidence Interval|Number
2836295|NCT00243061|Secondary|Change in Vessel Permeability and Blood Flow by DCE-MRI||From baseline to up to 28 days after starting daily oral dosing|data were not collected||||||
2836296|NCT00243061|Secondary|Changes in Levels of Soluble Angiogenic Factors||From baseline to up to 6 years|data were not collected||||||
2836297|NCT00243061|Secondary|Clinical Benefit Response||Up to 6 years|data were not collected||||||
2836298|NCT00243061|Secondary|Time to Disease Progression||Up to 6 years|9 patients developed progressive disease|||months||95% Confidence Interval|Median
2836299|NCT00243061|Secondary|Highest Toxicity Grade Assessed by NCI CTCAE Version 3.0||Up to 6 years after completion of treatment||||highest grade|||Number
2836300|NCT00243061|Secondary|Stable Disease Duration||From the start of the treatment until the criteria for progression are met, assessed up to 6 years|Only 17 of the 24 accrued patients were evaluable for response|||months||95% Confidence Interval|Median
2836301|NCT00243061|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years|None of the patients had Partial or complete response|||months|||Number
2836302|NCT00243061|Secondary|Survival Rate||At 1 year||||percentage of participants||95% Confidence Interval|Number
2836303|NCT00243061|Secondary|Median Survival Time||Up to 6 years||||months||95% Confidence Interval|Median
2836304|NCT00243061|Primary|Prolonged Stable Disease According to RECIST||Up to 6 months||||participants|||Number
2836305|NCT00243061|Primary|Objective Tumor Response (Partial or Complete Response) According to RECIST|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [J Nat Cancer Inst 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 6 years|Out of 24 patients analyzed, 0 patients had objective response of PR or CR as defined by RECIST|||participants|||Number
2836306|NCT00243022|Other Pre-specified|Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record|The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.|At 2, 4, 6, 12, and 24 months|No data collected||||||
2836440|NCT00240227|Primary|Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.||||||
2836308|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|1 year|All 12 patients followed to progression or death, or censored at last visit when known alive|||percentage of participants||95% Confidence Interval|Number
2836309|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|6 months|All 12 patients followed to progression or death, or censored at last visit when known alive|||percentage of participants||95% Confidence Interval|Number
2836310|NCT00243022|Secondary|Quality of Life at 6 Months|Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)|At 2, 4, 6, 12, and 24 months|At baseline and the most recent post treatment point in time, the QOL data for group 1 consist of n=3 patients and for group 2, n=2. Because of low patient numbers, no analysis was done.||||||
2836311|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema.|at 6 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.|||cm^3||Standard Deviation|Mean
2836312|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up - baseline edema.|at 4 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.|||cm^3||Standard Deviation|Mean
2836313|NCT00243022|Primary|Change From Pooled Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema|at 2 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.|||cm^3||Standard Deviation|Mean
2836314|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24|BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of total hip: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.|||percent change||Standard Error|Least Squares Mean
2836315|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of lumber spine: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.|||percent change||Standard Error|Least Squares Mean
2836316|NCT00242710|Secondary|Percentage of Participants With Hyperplasia at Month 24|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 24|EE analysis population for Year 2 included all randomized participants who took at least 1 dose of test article, participated in study extension, had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had biopsy during Month 24, or had hyperplasia diagnosed before Month 24 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2836317|NCT00242710|Secondary|Percentage of Participants With Uterine Bleeding or Spotting|Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for uterine bleeding or spotting included all randomized participants who had received at least 1 dose of test article and had at least 1 day of on-therapy bleeding data. Imputation=LOCF. n=participants evaluable for this measure at specified time periods for each arm, respectively.|||percentage of participants|||Number
2836328|NCT00242658|Primary|7-Day Physical Activity Recall (7-Day PAR)|Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.|6 months||||minutes||95% Confidence Interval|Mean
2836441|NCT00240162|Secondary|Disease Free Survival||Until the patient expires|This secondary outcome was not analyzed.||||||
2836805|NCT00234286|Secondary|Individuals Who Received Benzodiazepine Medication|Administration of benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836318|NCT00242710|Secondary|Percentage of Days With Breast Pain|Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for breast pain: all randomized participants who took at least 1 dose of test article, and had data available at least for 5 of 7 days at screening and 20 days for at least 1 post-baseline interval. n=participants evaluable at specified time periods for each arm, respectively.|||percentage of days||Standard Error|Mean
2836319|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12|BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.|||percent change||Standard Error|Least Squares Mean
2836320|NCT00242710|Primary|Bone Mineral Density (BMD) of Total Hip at Screening|BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.|||g/cm^2||Standard Deviation|Mean
2836321|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of lumber spine: all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after test article administration was stopped were excluded) at Year 1. Missing values imputed using last observation carried forward (LOCF).|||percent change||Standard Error|Least Squares Mean
2836322|NCT00242710|Primary|Bone Mineral Density (BMD) of Lumbar Spine at Screening|BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|Modified intent-to-treat (MITT) population for BMD of lumber spine included all randomized participants took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1.|||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
2836323|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Month 12|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 12|Efficacy evaluable (EE) analysis population for Year 1: all participants who were randomized and took at least 1 dose of test article, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2836324|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Screening|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Screening|Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.||||||
2836325|NCT00242684|Post-Hoc|Percentage of Subjects With Average Daily Nutrient Intake <90% of Predicted Needs||While hospitalized on TCU, for up to 40 days||||percentage of subjects|||Number
2836326|NCT00242684|Primary|Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs||While hospitalized on TCU, for up to 40 days||||percentage of subjects|||Number
2836327|NCT00242658|Secondary|Change in Behavioral Processes of Change Between Baseline and 6 Months|"Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never."|Baseline and 6 months||||Scores on a Scale||95% Confidence Interval|Mean
2836806|NCT00234286|Secondary|Individuals With an Order for Benzodiazepine Medication|Order for benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836329|NCT00242632|Secondary|Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2|The Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. The mean difference in the total number of correct words generated between time 1 and time 2 is calculated below.|6 months|All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.|||correct words||Standard Deviation|Mean
2836330|NCT00242632|Primary|Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2|This tests verbal memory (word list). A list of words is presented and subjects are asked to recall as many as they can. Then a list of interference words is presented. Finally a recognition list of 44 words is presented where subjects are asked to distinguish between target words and distractors. The mean difference in the percentage of target words recalled between time 1 and time 2 is calculated below.|6 months|All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.|||percentage of target words recalled||Standard Deviation|Mean
2836331|NCT00242619|Primary|Clinical Global Impression-Severity Scale (CGI-S)|The Clinical Global Impression-Severity Scale (CGI-S) assesses depression severity. It is a 7-point scale, where 1 is the lowest level of depression severity and 7 is the highest level of depression severity.|12 weeks||||units on a scale||Standard Deviation|Mean
2836332|NCT00242619|Primary|Hamilton Depression Rating Scale (HDRS-21)|The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.|12 weeks||||units on a scale||Standard Deviation|Mean
2836333|NCT00242580|Secondary|Mean Change From Baseline in Total Area of Lesion at 12 Months|Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||mm^2||Standard Deviation|Mean
2836334|NCT00242580|Secondary|Number of Participants Requiring Verteporfin Treatment Throughout the Study|Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.|Baseline to Month 12|Observed data.|||Participants|||Number
2836335|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
2836336|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
2836337|NCT00242580|Secondary|Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
2836338|NCT00242580|Primary|Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.|||Percentage of Participants|||Number
2836339|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|36 Months|The ITT Population consisted of all patients randomized to treatment.|||Days||95% Confidence Interval|Median
2836340|NCT00242567|Secondary|Skeletal-related Event(SRE)-Free Survival|Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.|36 months|The ITT Population consisted of all patients randomized to treatment.|||Days||95% Confidence Interval|Median
2836341|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|18 Months|The ITT Population consisted of all patients randomized to treatment.|||Days||95% Confidence Interval|Median
2836344|NCT00242502|Primary|Progression-free Survival (PFS) Rate|Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 16 weeks|Six participants were not evaluable.|||percentage of participants|||Number
2836345|NCT00242385|Secondary|Adverse Events (AEs)|"Investigators assessed severity of AEs (occurring during or after infusions) based on:~MILD: Transient discomfort, does not interfere in a significant manner with participant's normal functioning level; Resolves spontaneously or may require minimal therapeutic intervention MODERATE: AE produces limited impairment of function, can require therapeutic intervention; AE produces no sequelae; SEVERE: AE results in marked impairment of function, can lead to temporary inability to resume usual life pattern; AE produces sequelae, which require prolonged therapeutic intervention"|Throughout study period (7 months)|Safety Analysis Data Set - all study subjects who had evidence of receiving at least one dose of study medication regardless of any protocol violation.|||Events|||Number
2836346|NCT00242385|Secondary|Incremental Recovery|Computed from Cmax (mg/ml) divided by dose per kg body weight (mg/kg).|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||(mg/mL) / (mg/kg)||Full Range|Median
2836347|NCT00242385|Secondary|Time to Maximum α1-PI Concentration Post-infusion (Tmax)|Time to reach C-max. Tmax is the number of days from infusion to maximum concentration. Samples drawn at the end of infusion are considered to be time zero.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days||Full Range|Median
2836348|NCT00242385|Secondary|Maximum Plasma Concentration (Cmax)|Maximum α1-PI concentration following infusion|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||mg/mL||Full Range|Median
2836349|NCT00242385|Secondary|Terminal Half-life|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations above pre-infusion level.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days||Full Range|Median
2836350|NCT00242385|Secondary|Apparent Volume of Distribution at Steady State|Computed as weight-adjusted CL * MRT|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||mL||Full Range|Median
2836351|NCT00242385|Secondary|Mean Residence Time (MRT)|Computed as total area under the moment curve (AUMC) divided by total AUC|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days||Standard Deviation|Mean
2836352|NCT00242385|Secondary|Systemic Clearance (CL)|Computed as dose divided by AUC 0-infinity (AUC 0-infinity was calculated as the sum of AUC from time 0 to the time of last quantifiable concentration plus a tail area correction)|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||mL/day||Full Range|Median
2836353|NCT00242385|Secondary|Total Area Under the Curve Per Dose|Total area under the α1-PI concentration vs. time curve from pharmacokinetic day 0 to time infinity (AUC 0-infinity) per dose|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days*kg/mL||Full Range|Median
2836354|NCT00242385|Primary|Area Under the Curve/Dose|Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|All study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis|||days*kg/mL||Full Range|Median
2836355|NCT00242216|Secondary|CD4 Cell Count Change From Baseline During Treatment.||24 weeks.||||cell/mm3||Standard Deviation|Mean
2836356|NCT00242216|Primary|Proportion of Patient With Viral Load Less Than 400 Copies/mL||24 weeks||||percentage|||Number
2836357|NCT00241969|Primary|Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up|"This outcome measure examines the change in height for age Z-score (HAZ) from baseline to follow up. Height was measured standing unless the child was unwilling to stand, then a supine measurement was obtained. All measurements were obtained in triplicate and then the mean used for analyses.~Height for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean."|18 months||||Z-score||Standard Deviation|Mean
2836358|NCT00241969|Primary|Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment|"This outcome measure examines the change in weight for age Z-score (WAZ) from baseline to post treatment. Weight was measured in kilograms, measured to the nearest 100 grams, obtained using a digital scale by trained study staff. All measurements were obtained in triplicate and then the mean used for analyses.~Weight for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean."|6 months||||z-score||Standard Deviation|Mean
2836359|NCT00241969|Primary|Change in Energy Intake From Baseline to Post Treatment|This primary outcome measure compared change in energy intake from baseline to post treatment between the behavioral and nutrition treatment and the education and attention control treatment. Energy intake was assessed using a 7-day diet diary recorded by parents and analyzed using Nutrition Data System for Research Software, Version 2011. Data were examined as average kilocalories per day over the 7 day period at baseline and post treatment. The mean (SD) change in energy intake was compared between baseline to post treatment was|6 months||||kilocalories per day||Standard Deviation|Mean
2836360|NCT00241904|Secondary|Patients' Satisfaction With Care and Health Care Utilization|Patient satisfaction with care and healthcare utilization was measured with the Patient Assessment for Chronic Illness Care Scale (PACIC). The scores range from 0-5, with 5 being the most satisfied|Measured at 1 year||||units on a scale||Standard Deviation|Mean
2836361|NCT00241904|Primary|HbA1c|Fasting for 12 hour blood sample was measured in standardized lab|Measured at 1 year|Only the participants with a diagnosis of diabetes were assessed for this outcome measure|||percentage of hemoglobin||Standard Deviation|Mean
2836362|NCT00241904|Primary|Systolic Blood Pressure|Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.|Measured at 1 year||||mmHg||Standard Deviation|Mean
2836363|NCT00241904|Primary|Low-density Lipoprotein Cholesterol|Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab|Measured at 1 year||||mg/dL||Standard Deviation|Mean
2836364|NCT00241839|Secondary|Change in Uric Acid (UA) Levels: Baseline Less End of Treatment|Subjects on allopurinol are expected to lower their uric acid levels relative to placebo.|Baseline UA levels compared to end of treatment levels (8-10 weeks on allopurinol / placebo)|Change in uric acid from baseline to end of treatment.|||mg/dl||Standard Deviation|Mean
2836365|NCT00241839|Secondary|Change in Overall Mean BP From Those Obtained by 24 Hour Ambulatory Blood Pressure Measurements (ABPM) 8-10 Weeks Minus Baseline.|Subjects had 24 hr blood pressure monitoring (ABPM) at baseline and treatment end. The readings were averaged and the changes from baseline to treatment end were compared.|Baseline and end of treatment (8-10 weeks on allopurinol / placebo)|We obtained over 90% of those with cuff measures on the 24 hour BP measures (ABPM).|||mm Hg||Standard Deviation|Mean
2836366|NCT00241839|Primary|Change in Systolic Blood Pressure by Cuff After 8-10 Weeks Minus Baseline|"The systolic BP was taken at Baseline and after 8-10 weeks of treatment on placebo, while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.~The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.~Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol or placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).|||mm Hg||Standard Deviation|Mean
2836367|NCT00241839|Primary|Change in Diastolic Blood Pressure by Cuff 8-10 Weeks Minus Baseline|"The Diastolic BP was taken at Baseline and after 8-10 weeks of treatment or placebo while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.~The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.~Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol / placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).|||mm Hg||Standard Deviation|Mean
2836368|NCT00241644|Secondary|Number of Seropositive Subjects|Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.|||subjects|||Number
2836369|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Geometric mean concentrations are given as Units per milliliter (U/mL).|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.|||U/mL||95% Confidence Interval|Geometric Mean
2836370|NCT00241644|Secondary|Number of Seroconverted Subjects|Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects.|||subjects|||Number
2836371|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects|An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose.|One month after the last vaccine dose|Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects.|||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
2836372|NCT00241644|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the first dose of vaccine or placebo up to end of the study||||subjects|||Number
2836373|NCT00241644|Secondary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From the first dose of vaccine or placebo up to end of the study||||subjects|||Number
2836374|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.|||subjects|||Number
2836375|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.|||subjects|||Number
2836376|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.|||subjects|||Number
2836377|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.|||subjects|||Number
2836378|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 1 year of age to study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the second efficacy period.|||subjects|||Number
2836379|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the combined efficacy follow-up periods.|||subjects|||Number
2836380|NCT00241644|Secondary|Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy|||subjects|||Number
2836381|NCT00241644|Secondary|Number of Subjects Reporting Severe Gastroenteritis of Any Cause|Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy.|||subjects|||Number
2836382|NCT00241644|Secondary|In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the third dose of vaccine or placebo up to 1 year of age|"Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season.~For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group)."|||subjects|||Number
2836383|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From the first vaccine or placebo dose up to 1 year of age||||subjects|||Number
2836384|NCT00241644|Secondary|Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy|||subjects|||Number
2836385|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy|||subjects|||Number
2836386|NCT00241644|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy|||subjects|||Number
2836387|NCT00241631|Secondary|Total Sputum Eosinophils|Total eosinophils cells assessed from sputum|10 weeks||||millions cells/ml||95% Confidence Interval|Mean
2836388|NCT00241631|Secondary|Interleukin 8 (IL8)|Interleukin 8 (IL8) assessed from sputum|10 weeks||||ng/mL||95% Confidence Interval|Mean
2836389|NCT00241631|Primary|Sputum Inflammatory Cell Counts|Supernatant collect, cell pellets count on slides|10 weeks|Using marginal means as results|||millions cells/ ml||95% Confidence Interval|Mean
2836390|NCT00241358|Secondary|To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity|-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion|0 to 24 hours after dose of IV AMD3100|Pharmacokinetics were not performed on 2 patients who were considered replacement patients.|||ng*hr/mL||Full Range|Mean
2836391|NCT00241358|Secondary|To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax|-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion|0 to 24 hours after dose of IV AMD3100|Pharmacokinetics were not performed on 2 patients who were considered replacement patients.|||ng/ml||Full Range|Mean
2836392|NCT00241358|Secondary|Proportion of Donors Who Experience Infusional Toxicity (Donor Only)|-Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion|Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)||||Participants|||Count of Participants
2836393|NCT00241358|Secondary|Quality of Life During Stem Cell Mobilization (Recipients Only)||48-72 hours after last dose of AMD3100|-Quality of life questionnaires were not collected from the recipients.||||||
2836394|NCT00241358|Secondary|Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)|-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause|100 days after transplant|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.|||Participants|||Count of Participants
2836395|NCT00241358|Secondary|Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)|-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria|Between Day +100 and +365 post-transplant|Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100.|||Participants|||Count of Participants
2836396|NCT00241358|Primary|Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)|-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir|Day +21|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.|||Participants|||Count of Participants
2836397|NCT00241358|Primary|Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)|-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria|By Day 100 after transplant|Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.|||Participants|||Count of Participants
2836398|NCT00241358|Primary|Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)|-Defined as the proportion of donors collecting >2.0x106 CD34+ cells/kg [recipient weight]|Day 1-3||||Participants|||Count of Participants
2836399|NCT00241280|Primary|Rate of Contact Lens Related Serious and Significant Events (SSE)|The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.|Throughout the duration of the study (1 Year)|All subjects that were dispensed a study lens.|||percentage of Subjects|||Number
2836400|NCT00241280|Primary|Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40|Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.|Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks|The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.|||Percentage of Subjects Eyes|Participants||Number
2836442|NCT00240162|Secondary|Safety and Tolerability of PTK787/ZK 222584|Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.|30 days after treatment ends [median of 15 cycles (11-32)]|Only 13 out of the 21 participants experienced a grade 3 or 4 adverse event.|||adverse events|||Number
2836807|NCT00234286|Secondary|Individuals Administered Antipsychotic Medication|Administration of antipsychotic medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836401|NCT00241176|Secondary|Clinical Global Impression Severity Scores|The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)|24 Months||||units on a scale||Standard Deviation|Mean
2836402|NCT00241176|Primary|Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)|The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.|8 Weeks||||units on a scale||Standard Deviation|Mean
2836403|NCT00240994|Primary|The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation|Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.|Up to one year post kidney transplantation procedure|Intent-to-treat|||Proportion of participants|||Number
2836404|NCT00240981|Secondary|50-Meter Walking Speed (With a Load)|Change from baseline 50-Meter Walking Speed (with a load) at 6 months|baseline and 6 months|Participants with a baseline and one post baseline measure.|||meters/second||95% Confidence Interval|Mean
2836405|NCT00240981|Secondary|Total Fat Mass||baseline, 3 months, and 6 months||||Kilograms||Standard Deviation|Mean
2836406|NCT00240981|Secondary|Total Lean Mass||baseline, 3 months, and 6 months||||Kilograms||Standard Deviation|Mean
2836407|NCT00240981|Secondary|Late Life Functional Disability Index (LLFDI)|Percent change from baseline in the late life functional disability index at 6 months|baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
2836408|NCT00240981|Secondary|Stair-climbing Test (Loaded)|Change from baseline in Stair-climbing Test (loaded)|baseline and 6 months|Participants with one baseline and one post baseline measure.|||Watts||95% Confidence Interval|Mean
2836409|NCT00240981|Secondary|50-Meter Walking Speed (Without a Load)|Change from baseline 50-Meter Walking Speed (without a load) at 6 months|baseline and 6 months|Participants with a baseline and one post baseline measure.|||meters/second||95% Confidence Interval|Mean
2836410|NCT00240981|Secondary|Grip Strength|Change from baseline in grip strength in the dominant hand.|baseline and 6 months|The participants with baseline and one post baseline measure are included.|||Kilograms||95% Confidence Interval|Mean
2836411|NCT00240981|Secondary|Stair-climbing Test (Without a Load)|Change from baseline in the stair-climbing test (without a load) at 6 months.|baseline and 6 month|Participants with baseline and one post baseline measure.|||Watts||95% Confidence Interval|Mean
2836412|NCT00240981|Secondary|Chest-Press|Change from baseline in chest press strength at 6 months|baseline and 6 months|Participants with baseline and 1 post baseline measure.|||Newtons||95% Confidence Interval|Mean
2836413|NCT00240981|Primary|Changes in Physical Performance Measured by an Exercise Testing Regimen|Primary outcome was a change from baseline in leg-press strength at 6 months.|baseline and 6 months|Participants with baseline and at least one post baseline measure.|||Newtons||95% Confidence Interval|Mean
2836414|NCT00240539|Primary|Number of Subjects With Chronic and With Clinical HBV Infection|"Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points.~Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point."|From year 16 through to year 20||||subjects|||Number
2836415|NCT00240539|Primary|Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus|Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).|At Years 16, 17, 18,19 and 20 after primary vaccination|The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20.|||subjects|||Number
2836416|NCT00240539|Primary|Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.|At Years 16, 17, 18, 19 and 20 after primary vaccination|The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) & HBeAg(-) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group were analyzed.|||subjects|||Number
2836417|NCT00240526|Primary|Number of Subjects With Different Hepatitis B Infection Statuses|"Categories hepatitis B (HB) infection:~Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples~False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg.~Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples.~Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg"|Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)|Analysis was performed on the Long Term Total Cohort (LT total cohort). The maximum amount of subjects who have participated in any of the time points in this study has been given as number of participants analyzed.|||subjects|||Number
2836418|NCT00240526|Primary|Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection|Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker.|||subjects|||Number
2836808|NCT00234286|Secondary|Individuals With an Order for Antipsychotic Medication|Order for antipsychotic medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836419|NCT00240526|Primary|Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)|"Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.~Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||Subjects|||Number
2836420|NCT00240526|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||subjects|||Number
2836421|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).~Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||mIU/mL||95% Confidence Interval|Geometric Mean
2836422|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).~Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL."|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||mIU/mL||95% Confidence Interval|Geometric Mean
2836423|NCT00240500|Primary|Clinical Review for Hepatitis B Infection Status|Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points|Over the entire 4 year follow up period (17 - 20 years)||||participants|||Number
2836424|NCT00240500|Primary|Prevalence of Serological Markers for Hepatitis B Infection|It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe|Years 17, 18, 19 and 20.||||Percentage of participants (%)|||Number
2836425|NCT00240500|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.|Years 17, 18, 19 and 20.||||mIU/mL||95% Confidence Interval|Mean
2836426|NCT00240487|Primary|Mean PaO2/FiO2 Ratio|Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared|8 hours||||mmHg||Standard Deviation|Mean
2836427|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836428|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836429|NCT00240331|Secondary|Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836430|NCT00240331|Secondary|Number of Randomised Participants That Died From Non Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||||||
2836431|NCT00240331|Secondary|Number of Randomised Participants That Died From Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836432|NCT00240331|Secondary|Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836433|NCT00240331|Secondary|Number of Randomised Participants That Died From Any Cause.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836434|NCT00240331|Primary|Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||Participants|||Number
2836435|NCT00240227|Secondary|Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods||4 weeks|Study was terminated early. No final analyses completed.||||||
2836436|NCT00240227|Secondary|Change in Self-reports of Substance Use Between Study Medication and Placebo Periods||4 weeks|Study was terminated early. No final analyses completed.||||||
2836437|NCT00240227|Secondary|Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving||During lab session|Study was terminated early. No final analyses completed.||||||
2836438|NCT00240227|Secondary|Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.||||||
2836443|NCT00240162|Secondary|Time to Progression|"Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met.~25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation.~25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation.~35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.~Increase in the size of existing bone lesions or soft tissue plasmacytomas~New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression).~Hypercalcemia - corrected serum calcium > 11.5 mg/dL"|Until the patient progresses or expires (up to 457 days)|Participants were evaluable for time to progression if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.|||days||Full Range|Median
2836444|NCT00240162|Primary|Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug||Day 90|Participants were evaluable for response if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.|||participants|||Number
2836445|NCT00240110|Secondary|Change From Baseline in Percentage of Money Spent on Cocaine|Change from baseline in percentage of the amount of money spent on cocaine|week 12|All subjects with available data after assignment to study medications|||Percentage of Money Spent on Cocaine||Standard Deviation|Mean
2836446|NCT00240110|Primary|Change From Baseline in Percentage of Cocaine-abstinent Days|Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)|Week 12|All subjects with available data after assignment to study medications|||percentage of days cocaine abstinent||Standard Deviation|Mean
2836447|NCT00240097|Primary|Response Rate After Relapse|The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|3 weeks after 3rd cycle of starting therapy after relapse or refractory disease|All subjects dropped out or died prior to experiencing relapse||||||
2836448|NCT00240097|Secondary|Overall Survival (Part I)|Length of subject survival after starting study treatment|baseline to 2 years||||months||95% Confidence Interval|Median
2836449|NCT00240097|Primary|Objective Response Rate (Part I)|The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|baseline to 18 months||||Participants|||Number
2836450|NCT00240097|Secondary|Progression Free Survival (Part I)|Time to progressive disease|baseline to five years||||months||95% Confidence Interval|Median
2836451|NCT00240071|Secondary|Objective Response Rate (Defined as the Rate of Complete and Partial Responses).||From date of registration until disease progression or death, whichever occurs first||||participants|||Number
2836452|NCT00240071|Primary|Progression Free Survival (PFS)|Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.|From date of registration until disease progression or death, whichever occurs first|All participants entered onto study (intention to treat) (ITT) were analyzed.|||days||95% Confidence Interval|Median
2836453|NCT00239928|Primary|Summary of Adverse Events|Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events|Week 54 (initiation of A5751015 study) up to Week 198|Intent-to-treat|||participants|||Number
2836454|NCT00239928|Secondary|Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)|Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
2836455|NCT00239928|Secondary|Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)|Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
2836456|NCT00239928|Secondary|Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
2836457|NCT00239928|Secondary|Number of Responders|Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward"|||participants|||Number
2836458|NCT00239928|Secondary|Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point|"Value at each observation time point minus value at Week 54 (initiation of current study).~Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Weeks 54, every 18 weeks from Week 54 up to Week 198|"Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72.~Last Observation Carried Forward"|||letters||Standard Deviation|Mean
2836459|NCT00239928|Secondary|Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point|"Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202).~Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward"|||letters||Standard Deviation|Mean
2836460|NCT00239837|Secondary|Decision Making|"Cups task (Weller et al., 2007). On each trial, participants see 2 arrays with equal number of X cups (2, 3, or 5) each. On gain trials, participants informed that under each cup in one array is 1 quarter, and the other array includes 1 cup with Y quarters (either 2, 3, or 5), but the other cups have 0 quarters. Choosing from the riskless side leads to a sure gain of 1 quarter while choosing the risky side can lead to gain of Y quarters or no quarters. On loss trials, participants shown that choosing cup from 1 array will lead to 1 quarter taken away while choosing cup from other array will lead to no quarters or Y quarters taken. Cups task consists of 54 trials of 3 trials each of all combinations of 2 levels of domain (gain, loss). Expected Value Sensitivity (EV) calculated by subtracting proportion of risky choices made when EV actually favored the sure choice from proportion of risky choices made on trials where EV favored risky option. Score can range from -1.0 to -1.0."|Measured at age 15-17||||units on a scale||Standard Deviation|Mean
2836461|NCT00239837|Primary|Marijuana Use|The girls were asked how many times in the past year they had used marijuana. The response scale ranged from 1 (never) through 9 (daily). Units on a scale. Log transformed.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||log(units on a scale)||Standard Deviation|Mean
2836462|NCT00239837|Primary|Tobacco Use|The girls were asked how many times in the past year they had smoked cigarettes or chewed tobacco. The response scale ranged from 1 (never) through 9 (daily). Units on a scale.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||log(units on a scale)||Standard Deviation|Mean
2836463|NCT00239837|Secondary|Placement Changes|Child welfare system records were collected at each assessment to determine the girls' placement changes (including the number and type of changes). Placement changes since the start of the study through 12 months were summed for each girl. The number of placement changes ranged from 0 to 7 during this period. Units on a scale. Higher scores indicate more placement changes.|Measured at Months 6 and 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||placement changes||Standard Deviation|Mean
2836464|NCT00239837|Secondary|Social Competence|"Prosocial behavior was measured with a subscale from the Parent Daily Report (PDR; Chamberlain & Reid, 1987). The PDR was administered individually by telephone to foster parents on 3 consecutive or closely spaced days (1-3 days apart) at each assessment. A trained interviewer asked the foster parent whether a list of prosocial behaviors took place during the previous 24 hr (yes/no format). The prosocial scale was computed based on nine items, such as cleans up after herself and do a favor for someone. The PDR was designed to avoid the potential bias of aggregate recall of frequency estimates. Studies have reported concurrent and predictive validity of the PDR checklist. The scores were averaged (mean) across calls from 3 days. Scores on prosocial behavior at 6 and 12 months were averaged and the mean across both time points was used in analysis. Units on a scale. Range = 0-9. Higher scores indicate more prosocial behavior."|Measured at Months 6, 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||units on a scale||Standard Deviation|Mean
2836465|NCT00239837|Secondary|Participation in Risky Sexual Behaviors|Eight items from the girls' in-person interviews were used to assess health risking sexual behavior at the 36-month followup. The girls reported on items such as touching a boy's body above or below the waist, having sexual intercourse, having sex with someone who they just met, or having sex with someone using drugs in the past 12 months. Positive answers to these items were totaled to represent the cumulative number of health-risking sexual behaviors. The frequency of the cumulative number of risky sexual acts ranged from 0 to 7. Units on a scale. Higher scores indicate more health-risking sexual behaviors.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present|||units on a scale||Standard Deviation|Mean
2836466|NCT00239837|Secondary|Mental Health Problems|Internalizing and externalizing symptoms at 12 and 24 months were measured with caregiver report on the Achenbach System of Empirically Based Assessment (ASEBA). This widely used checklist for psychopathological behaviors includes scales for behaviors such as Anxious/Depressed; Withdrawn; Somatic Complaints; Thought Problems; Attention Problems; Aggressive Behavior; Rule-Breaking Behavior; and Intrusive. The ASEBA has been shown to have both construct and content validity in the literature. For the present study, raw scores for the internalizing and externalizing symptoms subscales were used. Scores at 12 and 24 months were combined and averaged (mean). Units on a scale. Range = 0-66. Higher scores indicate higher levels of internalizing or externalizing problems.|Measured at Months 12 and 24|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present|||units on a scale||Standard Deviation|Mean
2836539|NCT00238615|Other Pre-specified|Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen|This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.|Specimen collected at time of surgery|Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis.||||||
2836467|NCT00239837|Primary|Delinquency|36 items from the general delinquency scale from the Self-Report Delinquency Scale (SRD; Elliott, Huizinga, & Ageton, 1985). Units on a scale. Girls were asked to rate how many times they had committed various delinquent acts (e.g., damaging or destroying properties, and stealing) in the past year, using an open-ended format. The mean of frequencies across these items was used to represent the level of delinquency for girls. The general delinquency scale scores ranged from 0 to 24 (full scale) and from 0 to 13 (log transformed). Higher scores indicate higher levels of delinquency.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present|||log(units on a scale)||Standard Deviation|Mean
2836468|NCT00239733|Primary|Absolute Change in Platelet Count From Baseline||Through Week 12||||Participants|||Count of Participants
2836469|NCT00239733|Primary|Frequency and Severity of Adverse Events||Throughout study, for up to 12 weeks||||Participants|||Count of Participants
2836470|NCT00239720|Primary|Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months|"Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment~The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2].~Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20."|6 Months|Intent-to-treat||||||
2836471|NCT00239681|Secondary|Time to Bone Fracture|Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|Up to 5 years|Intention to treat population|||Days||Standard Error|Mean
2836472|NCT00239681|Secondary|Time to Venous Thromboembolic Event|Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
2836473|NCT00239681|Secondary|Time to Development of Diabetes Mellitus|Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
2836474|NCT00239681|Secondary|Time to Non-cardiovascular Death|Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
2836475|NCT00239681|Secondary|Time to Death Due to Any Cause|Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||days||Standard Error|Mean
2836476|NCT00239681|Primary|Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)|Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population|||Days||Standard Error|Mean
2836477|NCT00239642|Secondary|Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
2836478|NCT00239642|Secondary|Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects|||participants|||Number
2836479|NCT00239642|Secondary|Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive|Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
2836480|NCT00239642|Secondary|Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive|Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects|||participants|||Number
2836481|NCT00239642|Secondary|Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
2836482|NCT00239642|Secondary|Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12-week post-baseline period|mITT subjects|||participants|||Number
2836483|NCT00239642|Secondary|Percentage (%) of Subjects Achieving Clinical Success|Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects|||percentage of subjects|||Number
2836484|NCT00239642|Secondary|Number of Subjects Achieving Clinical Success|Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects|||participants|||Number
2836485|NCT00239642|Primary|Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event|Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm|baseline through week 12|Safety Population - Subjects who received at least 1 dose of study drug.|||participants|||Number
2836569|NCT00238108|Primary|Sleep Quality|Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)|Measurement after 3 weeks of supplementation|One subject was removed from analysis because of an unstable dose of prescription medication.|||% (% asleep during 8 hour opportunity)||Standard Error|Mean
2836486|NCT00239590|Secondary|Endothelial Function|The endothelium is a single layer of cells that line all blood vessels and regulates arterial function. Coronary artery disease causes dysfunction of the endothelium but some substances/drugs help to reverse this dysfunction. In this study, endothelial function was measured by radial applanation tonometry which measures the blood pressure waveform during each cardiac cycle (heart beat). Radial artery pulse recordings were acquired, with an averaged waveform generated from 20 sequential waveforms. Augmentation index (AIx) is derived from this averaged waveform, and is the ratio of the pulse pressure at the second systolic arterial pressure waveform peak to that of the first systolic peak. The change in AIx before and after salbutamol (400mcg) is a measure of endothelial function.|Testosterone versus placebo (8 week treatment period)|A total of 17 patients had endothelial function assessments - the same patients took both interventions in a randomized cross-over design.|||Augmentation index||Standard Deviation|Mean
2836487|NCT00239590|Primary|Myocardial Perfusion|"Myocardial perfusion (blood flow in the heart muscle) in subendocardial myocardial segments (one of the inner layers of heart muscle), supplied by coronary arteries without significant obstruction. This was measured using Cardiovascular Magnetic Resonance (CMR) imaging and a dual-bolus gadnolinium infusion protocol.~Myocardial perfusion index = the ratio between myocardial perfusion measurements following adenosine-induced stress and rest measurements."|Testosterone versus placebo (8 week treatment period)|22 patients had assessable CMR data for both evaluation visits.|||myocardial perfusion index||Standard Deviation|Mean
2836488|NCT00239577|Secondary|Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype|Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer <10 ED50 for any DEN type at pre-vaccination.|Before (PRE) and one month after the booster vaccination (Month 1)|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who completed the primary vaccination course, who had received the booster dose according to their random assignment and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2836489|NCT00239577|Secondary|Number of Subjects With Measurable Dengue Viremia|The number of subjects with measurable dengue viremia at specified timepoints.|At study Visit 12 (Days 2, 5, 8 or 12) (FU1), study Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) (FU2) and at study Visit 14 (Month 1 post-booster vaccination)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836490|NCT00239577|Secondary|Number of Subjects With Suspected and Confirmed Dengue|The number of subjects with suspected and confirmed Dengue post-booster vaccination.|During the 31-day (Days 0-30) follow-up after the study vaccine booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836491|NCT00239577|Secondary|Number of Subjects With Abnormal Findings at Dengue Physical Examination|The abnormal findings at Dengue physical examination included: Conjunctival hemorrhage, Conjunctival injection, Generalized lymphadenopathy, Generalized rash, Hepatomegaly, Lymphadenopathy, Mucosal hemorrhage, Rash, Skin hemorrhage and Splenomegaly. Rash involved < 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations. Note: Results only available during the 31-day follow-up period (Month 1) after the booster dose, instead of at each booster phase visit [pre-vaccination, study Visit 12 post-booster vaccination (Days 2, 5, 8 or 12), Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) and at Months 1 and 6 post-booster vaccination].|At Month 1 post-booster vaccination|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836492|NCT00239577|Secondary|Number of Subjects With Alert Values for Safety Laboratory Determinations|Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet).|During the 31-day (Days 0-30) follow-up after the study vaccine booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836493|NCT00239577|Secondary|Number of Subjects With Hematological and Biochemical Determinations Within and Outside the Normal Ranges|Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Note: No blood sample was taken for these laboratory tests at Month 6 post-booster vaccination.|At each booster phase visit [pre-booster vaccination (PRE), study Visit 12 post-booster vaccination (Days 2, 5, 8 or 12) (FU1), study Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) (FU2) and at Months 1 and 6 post-booster vaccination]|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836494|NCT00239577|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole booster phase of the study (from pre-vaccination up to Month 6 post-vaccination with the booster dose)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836809|NCT00234286|Secondary|Individuals Administered of Opioid Medication|Administration of opioid medication based on abstraction of medical record|Pre and Post Intervention||||participants|||Number
2836495|NCT00239577|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up after the study vaccine booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) for whom data were available.|||Participants|||Count of Participants
2836496|NCT00239577|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = oral fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 21-day (Days 0-20) follow-up after the study vaccine booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) with the symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2836497|NCT00239577|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 21-day (Days 0-20) follow-up after the study vaccine booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) with the symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2836498|NCT00239577|Secondary|Number of Subjects With Sero-response to Each DEN Type|Sero-response defined as: For initially seronegative subjects (antibody titer < 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer ≥ 10 ED50 at post-vaccination; For initially seropositive subjects (antibody titer ≥ 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.|At Months 1 and 7|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2836499|NCT00239577|Secondary|Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes|The antibody titers and pre-vaccination status were determined by MN50 with a cut-off value equal to 1:10.|At Months 1 and 7|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2836500|NCT00239577|Secondary|Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype|Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.|At Months 0, 1 and 7|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2836501|NCT00239577|Secondary|Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4|Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.|At Month 0 and Month 1|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||ED50||95% Confidence Interval|Geometric Mean
2836502|NCT00239577|Secondary|Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges|Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836503|NCT00239577|Secondary|Number of Subjects With Measurable Dengue Viremia|The number of subjects with measurable dengue viremia at specified timepoints. Negative = Genome equivalent (GEQ)/µL result is equal to zero; Undetermined = GEQ/µL result is below limit of detection (LOD); Positive = GEQ/µL result is ≥ LOD.|During the 31-day (Days 0-30) follow-up after each vaccine dose|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836504|NCT00239577|Secondary|Number of Subjects With Suspected and Confirmed Dengue|The number of subjects with suspected and confirmed Dengue post-vaccination.|During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836570|NCT00237809|Secondary|UCSD Performance-Based Skills Assessment (UPSA)|The UCSD Performance-Based Skills Assessment (UPSA) is a role-play test designed to evaluate a person's functional capacity in two selected areas of basic living skills. These areas include Finance and Communication. Subjects being tested utilize props to demonstrate how they perform everyday activities and are assessed on their actual performance. The higher the score, the better the performance of an individual. The scores range from 0 to 100.|12 weeks||||units on a scale||Standard Deviation|Mean
2849206|NCT00089141|Secondary|Bronchiolitis Obliterans|Development of bronchiolitis obliterans during treatment|within 4 years||||participants|||Number
2836505|NCT00239577|Secondary|Number of Subjects With Abnormal Findings at Dengue Physical Examination|The abnormal findings at Dengue physical examination included: Rash, Generalized Rash, Skin Hemorrhage, Conjunctival Hemorrhage, Conjunctival Injection, Mucosal Hemorrhage, Lymphadenopathy, Generalized Lymphadenopathy, Hepatomegaly and Splenomegaly. Rash involved < 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations.|During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836506|NCT00239577|Secondary|Number of Subjects With Alert Values for Safety Laboratory Determinations|Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet).|During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836507|NCT00239577|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole primary phase of the study (from Day 0 up to Month 9)|The analysis was performed on the Primary Total Vaccinated Cohort, included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836508|NCT00239577|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up after any study vaccine dose|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836509|NCT00239577|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 21-day (Days 0-20) follow-up after each dose of the study vaccine|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836510|NCT00239577|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 21-day (Days 0-20) follow-up after each dose of the study vaccine|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836511|NCT00239577|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) with the symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2836512|NCT00239577|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) with the symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2836513|NCT00239577|Primary|Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status|Titers for DEN 1, DEN 2, DEN 3 and DEN 4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer <10 ED50 for any DEN type at pre-vaccination.|At Month 1 post-booster dose of the study vaccine|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who completed the primary vaccination course, who had received the booster dose according to their random assignment and for whom data concerning immunogenicity outcome measures were available.|||ED50||95% Confidence Interval|Geometric Mean
2836613|NCT00237458|Primary|Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||participants|||Number
2836514|NCT00239577|Primary|Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status|Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer <10 ED50 for any DEN type at pre-vaccination.|At 5 to 12 months post-Dose 2 of the study vaccine|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who completed the primary vaccination course, who had received the booster dose according to their random assignment and for whom data concerning immunogenicity outcome measures were available.|||ED50||95% Confidence Interval|Geometric Mean
2836515|NCT00239577|Primary|Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4|Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.|At 30 days (Month 7) after Dose 2 of the study vaccine|The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||ED50||95% Confidence Interval|Geometric Mean
2836516|NCT00239577|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836517|NCT00239577|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine|The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.|||Participants|||Count of Participants
2836518|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population|Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline.|Baseline to end of study (Week 348|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each ECG parameter and includes those treated participants with ECG measurements.|||participants|||Number
2836519|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population|Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each vital sign parameter and includes those treated participants with vital sign measurements.|||participants|||Number
2836520|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.|||participants|||Number
2836538|NCT00238615|Primary|2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.|Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.|Two years|All patients alive and not censored at 2 years|||participants|||Number
2836810|NCT00234286|Secondary|Number of Individuals Who Died in Restraints|Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
2836521|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.|||participants|||Number
2836522|NCT00239356|Secondary|Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population|Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.|Day 1 to Day 1170|N=number of participants receiving drug at Days indicated.|||mg/day||Full Range|Mean
2836523|NCT00239356|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Baseline to Week 348|Safety Population: all participants with at least 1 dose of study drug.|||participants|||Number
2836524|NCT00239356|Primary|Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.|Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.|Baseline to Week 348|Safety Population - all participants who received at least one dose of drug. N=number of participants who were analyzed at each specific time point. Baseline N=97, 20 for first and second arms, respectively.|||units on a scale||Standard Deviation|Mean
2836525|NCT00239226|Secondary|Ventricular Pacing Percentage||January 2009|||||||
2836526|NCT00239226|Secondary|AF Burden||January 2009|||||||
2836527|NCT00239226|Secondary|Number of Episodes/Day||January 2009|||||||
2836528|NCT00239226|Secondary|Time to First Persistent Episode of Atrial Fibrillation (AF)||January 2009|||||||
2836529|NCT00239226|Secondary|Heart Failure: Comparison Between All Groups||January 2009|||||||
2836530|NCT00239226|Secondary|Number of Cardioversion: Comparison Between All Groups||January 2009|||||||
2836531|NCT00239226|Secondary|Symptom Scale Questionnaire: Comparison Between All Groups||January 2009|||||||
2836532|NCT00239226|Secondary|Number of Patients With Permanent Atrial Fibrillation (AF)||January 2009|||||||
2836533|NCT00239226|Secondary|Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups||January 2009|||||||
2836534|NCT00239226|Primary|Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group|Persistent Atrial Fibrillation (AF) incidence|1 year|97 pts completed the study after a mean fu period of 15±7 months.|||Number of patients with persistent AF|||Number
2836535|NCT00239005|Secondary|Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).|Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GIQLI questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.|||Units on a scale||Standard Error|Least Squares Mean
2836536|NCT00239005|Secondary|Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).|The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion—each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GSRS questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.|||Units on a scale||Standard Error|Least Squares Mean
2836537|NCT00239005|Primary|Mycophenolic Acid (MPA) Maintenance Treatment|The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.|at week 13 (last visit)|The intent-to-treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable.|||Percentage of Patients||95% Confidence Interval|Number
2836614|NCT00237458|Primary|Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||participants|||Number
2836540|NCT00238615|Secondary|Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival|The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.|baseline, 5 weeks after combined chemo-radiation|All enrolled patients were analyzed in the published manuscript|||standardized uptake value (SUV)max||Standard Deviation|Mean
2836541|NCT00238433|Primary|Therapy-Related Toxicities|The table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section.|Through 24 months post transplantation||||Participants|||Count of Participants
2836542|NCT00238433|Primary|Disease-Free Survival|The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points.|3, 6, 9, 12, 18, and 24 months post transplantation||||Participants|||Count of Participants
2836543|NCT00238420|Secondary|Five-year Overall Survival|Calculated using the Kaplan-Meier method.|From the date of treatment started to death, assessed up to at least 5 years||2020-10-31|10/2020||||
2836544|NCT00238420|Secondary|Five-year Disease-free Survival|Calculated using the Kaplan-Meier method.|From start of treatment progression to progression or death, assessed up to at least 5 years||2020-10-31|10/2020||||
2836545|NCT00238420|Secondary|Complete Response to Treatment|The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.|At 12 weeks from treatment start|All eligible patients who started treatment and had an evaluation to assess response by 12 weeks|||percentage of participants||95% Confidence Interval|Number
2836546|NCT00238420|Secondary|Treatment Completion|The number of patients within each group who completed all elements of protocol treatment are reported.|"From registration to end of treatment; up to 64 days."|All eligible patients who started study treatment|||participants|||Number
2836547|NCT00238420|Primary|Acute Treatment-related Toxicity|In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.|From start of protocol treatment to 90 days|All eligible patients who started study treatment|||participants|||Number
2836548|NCT00238355|Secondary|Safety||duration of study|||||||
2836549|NCT00238355|Secondary|Duration of Survival up to 12 Weeks||up to 12 weeks|||||||
2836550|NCT00238355|Primary|Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.|Patients will be followed through day 84 (12 weeks), regardless of continuation of study drugs. Complete response: Resolution of all clinical signs and symptoms and more than 90 percent of the lesions due to invasive fungus that were visible by radiology. Partial response: Clinical improvement and greater than 50 percent improvement in the lesions due to invasive fungus that were visible by radiology.|12 weeks after starting treatment||||Participants|||Number
2836551|NCT00238303|Secondary|Time to Progression|"Estimated using Kaplan-Meier survival curve.~Definition of progression:~Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|From registration to disease progression (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up.|||months||Full Range|Median
2836552|NCT00238303|Secondary|Confirmed Tumor Response|"A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method.~Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|"Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.~Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed."|||percentage of participants||95% Confidence Interval|Number
2836553|NCT00238303|Secondary|Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up.|||months||Full Range|Median
2847538|NCT00100698|Secondary|Change in Carotid Intima Media Thickness (IMT)|change in carotid intima media thickness (IMT)|18 months||||millimeter||Standard Error|Mean
2836554|NCT00238303|Primary|Proportion of Successes (Patients Alive and Progression-free)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method.~Definition of progression:~Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|At 6 months|68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.|||percentage of participants||95% Confidence Interval|Number
2836555|NCT00238264|Secondary|Correlation MIB-1 Labeling Index With PFS|The primary methods of analysis will be via stratified Cox regression|Up to 10 years|All eligible patients with MIB-1 data available were included in this analysis. Per protocol, patients were stratified by age and tumor location. Based on a predefined cutoff, patients were categorized as MIB high or low (high: >= 2; low: < 2). The hazard ratio below is for patients with MIB high (low is the reference level).|||Hazard ratio||95% Confidence Interval|Number
2836556|NCT00238264|Secondary|MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods|The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.|At baseline|All eligible patients with MIB-1 labeling index available.|||percentage of tumor nuclei||95% Confidence Interval|Number
2836557|NCT00238264|Secondary|Quality of Life (QOL)|QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).|Up to 5 years|The QOL assessments were removed from the protocol as part of Amendment #1A (as of 10/27/2010) due to extremely low compliance. No QOL data were available for statistical analysis.||||||
2836558|NCT00238264|Secondary|Overall Survival Probability|To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.|3 years|All eligible patients were included in the analysis, per protocol.|||Percentage 3-year OS rate||95% Confidence Interval|Number
2836559|NCT00238264|Secondary|Event-free Survival Probability|To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation|3 years|All eligible patients were included in the analysis, per protocol.|||Percentage 3-year EFS rate||95% Confidence Interval|Number
2836560|NCT00238264|Secondary|Progression-free Survival Probability|To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.|3 years|All eligible patients were included in the analysis, per protocol.|||Percentage 3-year PFS rate||95% Confidence Interval|Number
2836561|NCT00238264|Primary|Marginal-failure Rate|Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.|Up to 5 years|All evaluable patients were included in this analysis (n = 84). One eligible patient was deemed to be not evaluable due to progression during treatment, and was excluded from the analysis per protocol.|||percentage of failure rate|||Number
2836562|NCT00238238|Primary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.|||years||95% Confidence Interval|Median
2836563|NCT00238238|Primary|Overall Response Rate|Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.|Duration of treatment (12 cycles)|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.|||percentage of participants||95% Confidence Interval|Number
2836564|NCT00238121|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years||||Month||Full Range|Mean
2836565|NCT00238121|Secondary|Progression Free Survival|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years||||Month||95% Confidence Interval|Median
2836566|NCT00238121|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|Up to 5 years||||Month||95% Confidence Interval|Median
2836567|NCT00238121|Primary|Objective Overall Response Rate|Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.|Up to 5 years||||participants|||Number
2836568|NCT00238108|Secondary|Change in Systolic Blood Pressure|Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring|Measurement after 3 weeks of supplementation compared to baseline||||mmHg||Standard Error|Mean
2836811|NCT00234286|Secondary|Individuals With an Intravenous Line|Presence of intravenous line infusing at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
2836571|NCT00237809|Secondary|Simpson-Angus Neurological Rating Scale|Simpson-Angus Scale (SAS) is a 10-item rating scale that has been used widely for assessment in both clinical practice and research settings. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The highest possible score is 40.|12 weeks||||units on a scale||Standard Deviation|Mean
2836572|NCT00237809|Secondary|Heinrichs-Carpenter Quality of Life Scale|The Heinrichs-Carpenter Quality of Life Scale is a testing device. It has a range of possible scores, 0-126 used to evaluate social functioning & behavior in patients with schizophrenia-lower scores represent poorer mental health.|12 weeks||||units on a scale||Standard Deviation|Mean
2836573|NCT00237809|Primary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.|12 weeks||||units on a scale||Standard Deviation|Mean
2836574|NCT00237809|Primary|Spatial Span- Total Score|The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.|12 weeks||||units on a scale||Standard Deviation|Mean
2836575|NCT00237809|Primary|Hopkins Verbal Learning Test|The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.|12 weeks||||units on a scale||Standard Deviation|Mean
2836576|NCT00237809|Primary|Wisconsin Card Sorting Test (WCST)|"The WCST allows the clinician to speculate to the following frontal lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability."|12 weeks||||percentage of correct responses||Standard Deviation|Mean
2836577|NCT00237796|Secondary|Beck Anxiety Inventory (BAI)|The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.|baseline, mid-treatment, end of treatment, mid follow-up, and follow up||||units on a scale||Standard Deviation|Mean
2836578|NCT00237796|Secondary|Beck Depression Inventory-II (BDI-II)|The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up||||units on a scale||Standard Deviation|Mean
2836579|NCT00237796|Secondary|The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up||||units on a scale||Standard Deviation|Mean
2836580|NCT00237796|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).|baseline, mid treatment, end of treatment, mid follow-up, and follow up||||units on a scale||Standard Deviation|Mean
2836581|NCT00237796|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.|baseline, mid-treatment, end of treatment, mid follow-up, and followup||||units on a scale||Standard Deviation|Mean
2836582|NCT00237796|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up||||units on a scale||Standard Deviation|Mean
2836583|NCT00237796|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up||||units on a scale||Standard Deviation|Mean
2836584|NCT00237770|Primary|Systolic Blood Pressure During Head-up Tilt|Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.|Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.||||mmHg||Standard Deviation|Mean
2847539|NCT00100698|Secondary|Change in Adiponectin|Change in adiponectin|18 months||||mcg/mL||Standard Error|Mean
2836585|NCT00237744|Primary|M1 Activation Absolute Change Score|A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.|at baseline and following 3 months of treatment|This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group).|||voxels||Standard Deviation|Mean
2836586|NCT00237744|Primary|AMAT|The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.|prior to treatment and following 3 months of treatment||||seconds||Standard Deviation|Mean
2836587|NCT00237718|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.|||pg/ml||Standard Deviation|Mean
2836588|NCT00237718|Primary|F2-isoprostane (F2-iso)|F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.|||ng/ml||Standard Deviation|Mean
2836589|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at 12 month.~BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|12-month||||mmHg||Standard Deviation|Mean
2836590|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at Baseline.~BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|Baseline||||mmHg||Standard Deviation|Mean
2836591|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 18 Months|When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|18 month||||% of particpants with controlled SBP|||Number
2836592|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 12 Months|When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|12 month||||% of particpants with controlled SBP|||Number
2836593|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 6 Months|When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|6month||||% of particpants with controlled SBP|||Number
2836594|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at Baseline|When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|Baseline||||% of particpants w/ controlled BP|||Number
2836595|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)|Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
2836596|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
2836597|NCT00237666|Secondary|Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint|Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Score on a scale||Standard Deviation|Mean
2836598|NCT00237666|Secondary|Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2|"Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.~18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial."|Week 8||||percentage of subjects with CGI-I </=2||95% Confidence Interval|Number
2836599|NCT00237666|Secondary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale|Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
2836600|NCT00237666|Secondary|Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)|Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
2836601|NCT00237666|Primary|The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores|Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.|||Scores on a scale||Standard Deviation|Mean
2836602|NCT00237458|Secondary|"Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration and Treatment Phases."|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|From Titration Phase through Treatment Phase (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis.|||percentage of days||Standard Deviation|Mean
2836603|NCT00237458|Secondary|"Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration Phase."|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|Titration Period (approximately 6 weeks)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.|||percentage of days||Standard Deviation|Mean
2836604|NCT00237458|Secondary|"Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Baseline Phase."|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|Baseline Period (approximately 1 week)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.|||percentage of days||Standard Deviation|Mean
2836605|NCT00237458|Secondary|Investigator's Global Impression of Change In Pain During The Treatment Period.|"The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:~Much better~Moderately better~Mildly better~No change~Mildly worse~Moderately worse~Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||percentage of participants|||Number
2836606|NCT00237458|Secondary|Subject's Global Impression of Change In Pain During The Treatment Period.|"The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:~Much better~Moderately better~Mildly better~No change~Mildly worse~Moderately worse~Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||percentage of participants|||Number
2836607|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.|"Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).~Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful."|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2836608|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2836609|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2836610|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2836611|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2836612|NCT00237458|Secondary|Within-Subject Change In Average Daily Pain Score During the Treatment Period.|The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.|||units on a scale||Standard Deviation|Mean
2836615|NCT00237185|Secondary|Time to Progression (Core + Extension)|Time to progression was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2836616|NCT00237185|Secondary|Time to Onset of Response (Core + Extension)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2836617|NCT00237185|Secondary|Time to Onset of Response (Core)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||weeks||95% Confidence Interval|Median
2836618|NCT00237185|Secondary|Time to Treatment Failure (Core + Extension)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2836619|NCT00237185|Secondary|Time to Treatment Failure (Core)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis ate the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.|||weeks||95% Confidence Interval|Median
2836620|NCT00237185|Secondary|Progression Free Survival (PFS) (Core + Extension)|Progression free survival was analyzed as a time to event for each participant. If a participant had no event, then the PFS was censored at the last tumor assessment.|Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||months||95% Confidence Interval|Median
2836621|NCT00237185|Secondary|Duration of Response (Core + Extension)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.|||months||95% Confidence Interval|Median
2836622|NCT00237185|Secondary|Duration of Response (Core)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.|||weeks||95% Confidence Interval|Median
2836623|NCT00237185|Secondary|Overall Survival (Core + Extension)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||months||95% Confidence Interval|Median
2836624|NCT00237185|Secondary|Overall Survival (Core)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||months||95% Confidence Interval|Median
2836642|NCT00236938|Primary|Mean Change From Baseline to the Highest Hemoglobin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.|||g/dL||Standard Deviation|Mean
2836656|NCT00236197|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population|The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.|First 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.|||Participants|||Number
2836625|NCT00237185|Primary|Best Tumor Response (Core + Extension)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 156|Treatment population: the treatment population included all participants who had at least one dose of study medication.|||participants|||Number
2836626|NCT00237185|Primary|Best Tumor Response (Core)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 36|Treatment population: The treatment population included all randomized participants who received at least one dose of study medication.|||participants|||Number
2836627|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|12 months|Participants with 12 month follow up data. Intention to treat analysis.|||participants|||Number
2836628|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|12 months|Participants with 12 month follow up data. Intention to treat analysis.|||Units on a scale||Standard Deviation|Mean
2836629|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|6 Months|Participants with 6 month follow up data. Intention to treat analysis.|||participants|||Number
2836630|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|6 months|Participants with 6 month follow up data. Intention to treat analysis.|||units on a scale||Standard Deviation|Mean
2836631|NCT00236977|Secondary|Mean Change From Baseline in Hemoglobin (g/dL) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||g/dL||Standard Deviation|Mean
2836632|NCT00236977|Secondary|Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||percentage of change||Standard Deviation|Mean
2836633|NCT00236977|Secondary|Mean Change in Ferritin (ng/mL) From Baseline to Day 56||Change from Baseline at Day 56||||ng/mL||Standard Deviation|Mean
2836634|NCT00236977|Secondary|Highest Change From Baseline in Ferritin (ng/mL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.|||ng/mL||Standard Deviation|Mean
2836635|NCT00236977|Secondary|Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.|||g/dL||Standard Deviation|Mean
2836636|NCT00236977|Secondary|Number of Subjects With a Clinical Response|Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)|Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||participants|||Number
2836637|NCT00236977|Primary|Patients With an Increase in Hemoglobin >= 1gm/dL.||Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.|||participants|||Number
2836638|NCT00236951|Primary|Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).|The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).|During Stage 2 (week 9 through week 21)|intention to treat (ITT)|||g/dL||Standard Deviation|Mean
2836639|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)|||percentage of change||Standard Deviation|Mean
2836640|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Ferritin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)|||ng/mL||Standard Deviation|Mean
2836641|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)|||percentage of change||Standard Deviation|Mean
2836643|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.|||participants|||Number
2836644|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.|||participants|||Number
2836645|NCT00236899|Secondary|Number of Participants With Serious and Nonserious Adverse Events (AEs)|Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as the population of all randomized participants.|||participants|||Number
2836646|NCT00236899|Secondary|Overall Response Rate(ORR) by Treatment Drug|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.|||percentage of responses|||Number
2836647|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Drug|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.|||months||95% Confidence Interval|Median
2836648|NCT00236899|Secondary|Overall Response Rate (ORR) by Treatment Schedule|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.|||percentage of responses|||Number
2836649|NCT00236899|Secondary|Overall Survival (OS) by Treatment Drug|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.|||months||95% Confidence Interval|Median
2836650|NCT00236899|Secondary|Overall Survival (OS) by Treatment Schedule|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.|||months||95% Confidence Interval|Mean
2836651|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Schedule|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.|||months||95% Confidence Interval|Median
2836652|NCT00236197|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period|||||||
2836653|NCT00236197|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period|||||||
2836654|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Nighttimes||14-day randomized treatment period|||||||
2836657|NCT00236184|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.|"Subject was considered complete relief if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity."|first 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.|||participants|||Number
2836658|NCT00236184|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
2836659|NCT00236184|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
2836660|NCT00236184|Secondary|Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
2836661|NCT00236184|Secondary|Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.|||||||
2836662|NCT00236080|Primary|Psychomotor Vigilance Task (PVT)|The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.|Endpoint (Visit 4) change from baseline (Visit 2)|Of the patients who completed the study, 1 patient in the PROVIGIL 200 mg/day treatment group and 1 patient in the Armodafinil 150 mg/day treatment group did not complete their PVT assessment.|||Milliseconds||Standard Deviation|Mean
2836663|NCT00236080|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.|Endpoint (Visit 4) change from baseline (Visit 2)|"1 Placebo Patient did not have an MSLT but did complete the other Primary Measure (PVT) and other requirements. This patient was termed a Completer.~1 Patient in the Armodafinil 200 mg/day group had an MSLT performed but then discontinued the study drug before reaching the study endpoint and was termed a Non-Completer for the Study."|||Minutes||Standard Deviation|Mean
2836664|NCT00235989|Secondary|Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b|Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).|At End of Study Visit (week 234)|For the NAb analyses data were provided for 40 patients instead of 61 for week 234. Twenty-one patients had no data at this visit.The entries in the table are the number of patients with positive titer in the extension treatment cohorts for the three cutoff titer values. The analyses provide frequencies of positive titers.|||participants|||Number
2836665|NCT00235989|Primary|Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities|Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.|At End of Study Visit (week 234)|The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.|||participants|||Number
2836666|NCT00235872|Secondary|Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit|Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||IU/mL||Standard Deviation|Mean
2836667|NCT00235872|Secondary|Presence of Rheumatoid Factor (RF)|The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||participants|||Number
2836722|NCT00235495|Secondary|Symptomatic Intracerebral Hemorrhage (ICH) Within 24 Hours||within 24 hours|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 24 hours.|||Participants|||Count of Participants
2836812|NCT00234286|Secondary|Individuals With a Nasogastric Tube|Presence of nasogastric tube based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
2836668|NCT00235872|Secondary|Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit|Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||minutes||Standard Deviation|Mean
2836669|NCT00235872|Secondary|Presence of Morning Stiffness|The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||participants|||Number
2836670|NCT00235872|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mg/dL||Standard Deviation|Mean
2836671|NCT00235872|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on a scale||Standard Deviation|Mean
2836672|NCT00235872|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on unit scale||Standard Deviation|Mean
2836673|NCT00235872|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on unit scale||Standard Deviation|Mean
2836674|NCT00235872|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit|Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||mm on a scale||Standard Deviation|Mean
2836675|NCT00235872|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||SJC||Standard Deviation|Mean
2847540|NCT00100698|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure|18 months||||mm Hg||Standard Error|Mean
2836676|NCT00235872|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||TJC||Standard Deviation|Mean
2836677|NCT00235872|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.|||participants|||Number
2836678|NCT00235833|Secondary|Number of Subjects With Morning Stiffness at Each Visit|The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.|||participants|||Number
2836679|NCT00235833|Secondary|Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)|Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)|Every 6 weeks up to Week 24 and every 12 weeks thereafter||||Weeks||Standard Deviation|Mean
2836680|NCT00235833|Secondary|Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mg/dL||Standard Deviation|Mean
2836681|NCT00235833|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).], a component the of ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||units on a scale||Standard Deviation|Mean
2836682|NCT00235833|Secondary|Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mm on scale||Standard Deviation|Mean
2836683|NCT00235833|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mm on scale||Standard Deviation|Mean
2836684|NCT00235833|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||mm on scale||Standard Deviation|Mean
2836685|NCT00235833|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit|Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||SJC||Standard Deviation|Mean
2836686|NCT00235833|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)||||TJC||Standard Deviation|Mean
2836813|NCT00234286|Secondary|Number of Patients Who Died in ICU|Location of death (ICU vs. other) based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
2836687|NCT00235833|Primary|Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)|Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts [TJC or SJC, respectively] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity [PGA], [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein [CRP]) at each visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Analysis was based on observed data.|||participants|||Number
2836688|NCT00235755|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.|||participants|||Number
2836689|NCT00235755|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.|Baseline (Week -7 through 0), Weeks 8 and 16|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.|||milliliters||Full Range|Median
2836690|NCT00235755|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 16|Safety Population|||participants|||Number
2836691|NCT00235755|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 16|Safety Population|||participants|||Number
2836692|NCT00235755|Secondary|Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 4, 8, and 16|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Only participants with QOLIE-31-P data were included in the analysis.|||scores on a scale||Standard Deviation|Mean
2836693|NCT00235755|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population. Only participants with post-baseline PGI scores were included in the analysis.|||scores on a scale||Standard Deviation|Mean
2836694|NCT00235755|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population|||scores on a scale||Standard Deviation|Mean
2836695|NCT00235755|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.|Week 5 through Week 16|ITT EMEA Population|||percentage of days||Full Range|Median
2836696|NCT00235755|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 16|ITT FDA Population. Only participants who had post-baseline seizure data were included in the analysis.|||percentage of days||Full Range|Median
2836697|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 5 through Week 16|ITT EMEA Population|||participants|||Number
2836723|NCT00235495|Secondary|Shortness of Breath Within 48 Hours||within 48 hours|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 48 hours.|||participants|||Number
2836698|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 16|ITT FDA Population. Only participants with post-baseline seizure data were included in the analysis.|||participants|||Number
2836699|NCT00235755|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population|||participants|||Number
2836700|NCT00235755|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population|||participants|||Number
2836701|NCT00235755|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population|||participants|||Number
2836702|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population|||participants|||Number
2836703|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the No reduction category."|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population|||participants|||Number
2836704|NCT00235755|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population|||Percent change in seizure frequency||Full Range|Median
2836705|NCT00235755|Secondary|Number of Participants Who Were Responders and Non-responders During the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 16|ITT FDA Population|||participants|||Number
2836706|NCT00235755|Primary|Number of Participants Classified as Responders and Non-responders During the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 5 through Week 16|ITT European Medicines Evaluation Agency (EMEA) Population: all randomized participants who had received at least 1 dose of study drug in the Maintenance Phase and had at least 1 seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase.|||participants|||Number
2836707|NCT00235755|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)|Intent-to-Treat Food and Drug Administration (ITT FDA) Population: all randomized participants (P) who received at least 1 dose of study drug. Only participants with post-BL seizure data are included in this analysis.|||percent change in seizure frequency||Full Range|Median
2836708|NCT00235716|Other Pre-specified|All-cause Mortality|Survival analysis of death from any cause.|up to 4 years|Intention-to-treat analysis that includes all randomized participants.|||participants|||Number
2836724|NCT00235495|Secondary|Pulmonary Edema Within 48 Hours||within 48 hours|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 48 hours.|||participants|||Number
2836814|NCT00234286|Secondary|Do Not Resuscitate Order|Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record|Pre and Post Intervention||||participants|||Number
2836709|NCT00235716|Primary|Caregiver Activity Survey Change From Baseline|The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||hours per day||Standard Error|Least Squares Mean
2836710|NCT00235716|Primary|Neuropsychiatric Inventory Change From Baseline|The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
2836711|NCT00235716|Primary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline|The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
2836712|NCT00235716|Primary|Mini-Mental State Examination Change From Baseline|The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
2836713|NCT00235716|Secondary|Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)|The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5).|Every 6 months to a maximum of 4 years|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||participants|||Number
2836714|NCT00235716|Primary|Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline|The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.|||units on a scale||Standard Error|Least Squares Mean
2836715|NCT00235573|Secondary|Total Transcobalamin Measured at Intervals From Baseline to 48 Hours.||Baseline through 48 hours at intervals of 0, 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6, 7, 8, 9, 10, 11, 11.5, 12.5, 24, 48|||||||
2836716|NCT00235573|Primary|Change in Holo-transcobalamin|Holo-TC is a vitamin B12 carrier protein. Only vitamin B12 bound to holo-TC can be taken up by cells. Changes in holo-TC after an oral dose of vitamin B12 may provide a clinical test to assess vitamin B12 absorption. The change in holo-transcobalamin (holo-TC) from baseline was measured at timed intervals in response to supplemental vitamin B12 and compared to baseline. The purpose was to ascertain the time point at which holo-TC reaches the maximum concentration in the blood following a dose of vitamin B12 in subjects without defects in vitamin B12 absorption.|Holo-transcobalamin measured at 24 hours after baseline|The number of participants for analysis was per protocol.|||pmol/L||Standard Deviation|Mean
2836717|NCT00235547|Secondary|Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment|An effective method is defined as a hormonal method or intra-uterine device|six months post enrollment||||Participants|||Count of Participants
2836718|NCT00235547|Primary|Number of Participants Who Use Patch After Abortion, by Study Arm|we will also describe what participants were using two months post-abortion|six months after enrollment/abortion|randomized subjects who completed the six month survey|||Participants|||Count of Participants
2836719|NCT00235495|Secondary|Death Within 90 Days||within 90 days|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 90 days.|||participants|||Number
2836720|NCT00235495|Secondary|Death Within 30 Days||within 30 days|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 30 days.|||participants|||Number
2836721|NCT00235495|Secondary|Asymptomatic ICH Within 24 Hours||within 24 hours|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 24 hours.|||Participants|||Count of Participants
2836725|NCT00235495|Secondary|Atrial Fibrillation Within 48 Hours||within 48 hours|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 48 hours.|||participants|||Number
2836726|NCT00235495|Secondary|Recurrent Ischemic Stroke Within 30 Days||within 30 days|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 30 days.|||participants|||Number
2836727|NCT00235495|Secondary|Neurological Death Within 7 Days||within 7 days|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 7 days.|||participants|||Number
2836728|NCT00235495|Secondary|Number of Participants With Neurological Deterioration Within 48 Hours|This is assessed as the number of participants with a neurological adverse event.|within 48 hours|The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 48 hours.|||Participants|||Count of Participants
2836729|NCT00235495|Secondary|Trailmaking B|"The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a trail made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete ach part. Normally, the entire test (A and B) can be completed in 5-10 minutes."|at 90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Minutes||Inter-Quartile Range|Median
2836730|NCT00235495|Secondary|Trailmaking A|"The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a trail made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete ach part. Normally, the entire test (A and B) can be completed in 5-10 minutes."|at 90 days|Participants were excluded if the Tail Making Test was not assessed.|||Minutes||Inter-Quartile Range|Median
2836731|NCT00235495|Secondary|Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3|Stroke, specific, health-related quality of life (SSQoL) is a self-reported survey that includes 12 domains and 49 items which are scored on a 5pt Likert response format with a lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. Each Domain Score and the Overall Total Score all range from 1-5 with 1 being worst and 5 being the best. We have presented data here for the number of participants that have an unweighted average of domain scores of 3 or greater.|at 90 days||||Participants|||Count of Participants
2836732|NCT00235495|Secondary|Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78|The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores.|at 90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836733|NCT00235495|Secondary|Barthel Index (BI) 95-100|The Barthel Index (BI) is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables - feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. the highest total score for fully independent subjects equals 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence.|at 90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||participants|||Number
2836734|NCT00235495|Secondary|Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS)|"Assessed as the final global disability level on the modified Rankin scale (mRS) at 90 days better than expectation (sliding dichotomy analysis) ) assessed in the intention to treat population.~mRS Scale:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836735|NCT00235495|Secondary|The Number of Participants With a Score on the mRS of 0-2 at 90 Days.|The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead.|at 90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2848301|NCT00094900|Secondary|Mean Change in Prednisone Dose||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
2836736|NCT00235495|Secondary|The Number of Participants With a Score on the mRS 0-1 at 90 Days.|The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead.|at 90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836737|NCT00235495|Secondary|Number of Participants With a NIHSS 0-1 at 90 Days.|The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit.|at 90 days|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836738|NCT00235495|Secondary|Number of Participants With a NIHSS of 0-1 at 24 Hours|The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit.|at 24 hours|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836739|NCT00235495|Secondary|Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points||at 3 months|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836740|NCT00235495|Primary|The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1.|The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. The mRS ranges from 0-6 representing perfect health without symptoms to death. A score of 0 is no symptoms at all and a score of 1 is no significant disability. Able to carry out all usual duties and activities.|at 3 months|Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.|||Participants|||Count of Participants
2836741|NCT00235456|Secondary|Hospital Length of Stay|The number of days patient stayed in the hospital after surgery.|time to hospital discharge after surgery||||days||Standard Deviation|Mean
2836742|NCT00235456|Secondary|Staples Removed|Time to staples removed, measured in days|time to event after surgery||||days||Standard Deviation|Mean
2836743|NCT00235456|Secondary|First Solid Food Intake|Time to restarting feeding after surgery, measured in days.|time to event after surgery||||days||Standard Deviation|Mean
2836744|NCT00235456|Secondary|Return to Ambulation|time to return to ambulation after surgery, measured in days|time to event after surgery||||days||Standard Deviation|Mean
2836745|NCT00235456|Secondary|Return of Bowel Function|Time to return of bowel function, measured in days.|time to event after surgery to discharge from hospital||||days||Standard Deviation|Mean
2836746|NCT00235456|Primary|Incisional Surgical Wound Infection|Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.|0 to 14 days after surgery||||participants|||Number
2836747|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)|Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836748|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)|Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836749|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)|Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836750|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)|Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836751|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836752|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836796|NCT00234494|Secondary|Duration of Response for Responding Patients|To estimate duration of response for responding patients.|36 months|Data for this secondary outcome measure was not collected or analyzed.||||||
2836753|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable (intolerable)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836754|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable (like poison oak)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836755|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable (raw skin)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836756|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable (freezing)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836757|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836758|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable (on fire)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836759|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable (like a knife)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836760|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836761|NCT00235443|Secondary|Patient's Global Impression of Change (PGIC) From Baseline in Pain.|Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Participants|||Number
2836762|NCT00235443|Secondary|Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).|Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836763|NCT00235443|Secondary|Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).|Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Units on a scale||Standard Deviation|Mean
2836764|NCT00235443|Primary|Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.|Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).|Throughout the study up to a maximum study period of 2.8 years|Safety population are subjects who took at least one dose of lacosamide (LCM).|||Participants|||Number
2836765|NCT00235391|Secondary|The Change in Serum Ferritin Values From Baseline Through Completion of the Study|The number of participants with Improvement, No Change or Worsening in Serum ferritin category levels at the end of the study compared to baseline. Serum ferritin levels in µg/L were divided into to 6 categories: (<1000), (1000-<2500), (2500-<4000), (4000-<5500), (5500-<7000) and (>=7000). Improvement was defined as a shift to a lower category at the end of study compared to the category at baseline. Worsening was defined as a shift to a higher category at the end of the study compared to the category at baseline. No change was no change in category at end of study from baseline.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|Safety population defined as all participants who received at least one dose of study drug. This analysis did not include participants with unknown status at baseline and/or at the end of the study.|||Participants|||Number
2836766|NCT00235391|Primary|Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events|Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|The safety population, comprising all participants who received at least one dose of deferasirox during the study, was used in the analyses.|||Participants|||Number
2836767|NCT00235326|Primary|Number of Participants With Post Infectious Irritable Bowel Syndrome||8 years||||participants|||Number
2836768|NCT00234884|Primary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||units on a scale||Standard Deviation|Mean
2836769|NCT00234884|Primary|American College of Rheumatology 70% (ACR70) Response Rate|ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||participants|||Number
2836770|NCT00234884|Primary|American College of Rheumatology 50% (ACR50) Response Rate|ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||percentage of participants|||Number
2836771|NCT00234884|Primary|American College of Rheumatology 20% (ACR20) Response Rate|ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||percentage of participants|||Number
2836772|NCT00234884|Primary|Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)|DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.|||units on a scale||Standard Deviation|Mean
2836773|NCT00234832|Secondary|Risk of Experiencing Cardiovascular Death Included in the POE|For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
2836774|NCT00234832|Secondary|Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE|For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
2836775|NCT00234832|Secondary|Risk of Experiencing a Nonfatal Stroke Included in the POE|For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
2836776|NCT00234832|Secondary|Risk of Experiencing a Nonfatal MI Included in the POE|For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
2836777|NCT00234832|Secondary|Risk of Experiencing a POE or a Revascularization Procedure|This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
2836778|NCT00234832|Secondary|Risk of Death From Any Cause (All-cause Mortality)|For each subject who died, the time to death was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.|||Participants|||Number
2836797|NCT00234494|Secondary|Estimate Response Rates|To estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR).|36 months||||percentage of participants|||Number
2836798|NCT00234494|Secondary|Overall Survival Time|To estimate overall survival time in months.|36 months||||months||95% Confidence Interval|Median
2836779|NCT00234832|Primary|Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)|For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.|From randomization up to 6 years|Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.|||Participants|||Number
2836780|NCT00234533|Secondary|Extent of Exposure to NutropinAq Throughout the Study|The extent of treatment exposure throughout the study is presented as the mean number of daily injections performed.|Up to Week 24|The Safety Population consisted of all patients who received at least one injection of treatment.|||days||Standard Deviation|Mean
2836781|NCT00234533|Secondary|Posology of NutropinAq at Baseline (Visit 1) Summarised as Mean Dose|It was intended that the posology (mg/kg/day) of NutropinAq would remain constant throughout the study. The mean posology adopted at Visit 1 is presented.|Visit 1 (Baseline)|The Safety Population consisted of all patients who received at least one injection of treatment.|||mg/kg/day||Standard Deviation|Mean
2836782|NCT00234533|Secondary|Percentage of Patients Rating the Overall Handling of the Administration Device, NutropinAq Pen, to Assess the Acceptability and Tolerance of NutropinAq and Its Pen|"The acceptability was evaluated by a questionnaire at Month 5. The users (parents and/or child) of NutropinAq pen and compliance aid booklet were asked to describe and rate the pen, cartridge, compliance aid booklet and their ease of use.~The percentage of patients responding to each category for the assessment of the overall handling of the NutropinAq pen are presented. The categories are: Very easy, Easy, Moderately difficult, Difficult, Very difficult and Missing."|At Month 5|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||Percentage of patients|||Number
2836783|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity SDS|"The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Annualised GV SDS = (annualised GV - reference mean annualised GV (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth velocity, therefore, a favorable outcome.~Change from baseline in the annualised growth velocity SDS at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||SD Score||Standard Deviation|Mean
2836784|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Annualised Growth Velocity|"The auxological parameter, annualised growth velocity, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24).~Change from baseline in the measured annualised growth velocity at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||cm/year||Standard Deviation|Mean
2836785|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Calculated Weight SDS|"The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Weight SDS = (weight - reference mean weight (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in weight, therefore, a favorable outcome.~Change from baseline in the calculated weight SDS at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||SD Score||Standard Deviation|Mean
2836786|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Weight|"The auxological parameter, weight, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24).~Change from baseline in measured weight at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||kg||Standard Deviation|Mean
2836787|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Calculated Height SDS|"The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24). The French growth charts were used for the calculation of SDS parameters: the charts provide for each age range and sex a mean parameter and SD value, from which the SDS parameter can be derived assuming a normal distribution. For example: Height SDS = (height - reference mean height (age, sex)) / reference SD (age, sex). The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A positive change in SDS indicates an improvement in growth, therefore, a favorable outcome.~Change from baseline in the calculated height SDS at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||SD Score||Standard Deviation|Mean
2836788|NCT00234533|Secondary|Change From Baseline at Week 24 in the Auxological Parameter Height|"The auxological parameter, height, was measured at Visit 1 (Baseline measurement), Visit 2 (Week 12) and Visit 3 (Week 24).~Change from baseline in measured height at Visit 3 (Week 24) for the overall ITT population is presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||cm||Standard Deviation|Mean
2836789|NCT00234533|Secondary|Change From Baseline at Week 12 and Week 24 in Insulin-Like Growth Factor Binding Protein 3 (IGFBP3) Measurements|"The LWPES recommends that treatment for any indication with recombinant GH therapy in children be accompanied by regular monitoring of IGF-I and IGFBP3 concentrations. IGFBP3 binds circulating IGF-I and serum samples were taken at Visit 1 (Week 0), Visit 2 (Week 12) and Visit 3 (Week 24) in order to measure IGFBP3.~Change from baseline (Visit 1) at Visits 2 and 3 in IGFBP3 is presented."|Baseline to Week 12 and Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Evaluable subjects with data available at each timepoint are presented.|||ng/mL||Standard Deviation|Mean
2836790|NCT00234533|Secondary|Change From Baseline at Week 24 in the IGF-I Levels as Measured by Capillary Blood Spot Method and Serum IGF-I Assay|"3 simultaneous IGF-I measurements were taken at Weeks 0 (baseline), 12 and 24 by serum and capillary assay to determine the precision profile of the capillary blood spot method versus the serum IGF-I assay.~Change from baseline at Week 24 in the IGF-I measurements by capillary blood spot method and serum assay are presented."|Baseline to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Evaluable subjects with data available at Week 24 are presented.|||ng/mL||Standard Deviation|Mean
2836791|NCT00234533|Secondary|Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Time of Year, Calculated Age at Enrolment and Disease Condition|"A multivariate linear regression analysis of factors on WCV using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of the time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition on the IGF-I value were assessed.~Parameter estimates from the statistical model are presented as least squares means for the categories of time of the year (1st, 2nd, 3rd and 4th quarters), calculated age at enrolment and disease condition (GHD and TS)."|Up to Week 24|The Per Protocol Population consisted of all patients in the ITT Population for whom no major protocol violations/deviations occurred. Only evaluable subjects within each of the individual subgroups are presented for each category.|||Regression coefficient||Standard Error|Least Squares Mean
2836792|NCT00234533|Secondary|Multivariate Linear Regression Analyses to Assess Factors Affecting the Variability of IGF-I Levels: Categorised by Disease Condition and Location|"A multivariate linear regression analysis of factors on within-subject coefficient of variation (WCV) using a stepwise forward-backward elimination was used to determine the effect of individual factors on IGF-I values as measured using the capillary blood spot method (p=0.15 for a variable to enter and remain in the model). The WCV was computed from the series of 6 measurements (2 samplings in each of Weeks 21, 22 and 23). The influence of disease condition and country clusters on the IGF-I value were assessed.~Country clusters: cluster 1: France; cluster 2: Spain, Greece, Romania and Italy; cluster 3: UK, Belgium, Czech Republic, Denmark, Germany, Slovakia, Austria and Finland ; cluster 4: Russia ; cluster 5: Ukraine.~Parameter estimates from the statistical model presented as least squares means for categories of disease condition (GHD and TS) and location (Clusters 1, 2, 3, 4 and 5) are presented."|Up to Week 24|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Only evaluable subjects within each of the individual subgroups are presented for each category. As there was only 1 patient with CRI, no analysis was performed for this disease condition.|||Regression coefficient||Standard Error|Least Squares Mean
2836793|NCT00234533|Secondary|Assessment of IGF-I Levels: Categorised by Sex and Prepubertal Status|The influence of sex and prepubertal status on the IGF-I value as measured using the capillary blood spot method was analysed. Parameter estimates from the statistical model are presented as least squares means for the categories of sex (male and female) and prepubertal status (pubertal and prepubertal). The values reported represent average IGF-I levels as determined from the 6 measurements taken (i.e. morning and evening samples at Weeks 21, 22 and 23).|At Weeks 21, 22 and 23|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||ng/mL||95% Confidence Interval|Least Squares Mean
2836794|NCT00234533|Secondary|Assessment of IGF-I Levels: Categorised by Weekly Timing (Weeks 21-23) and Daily Timing (Morning and Evening)|The influence of daily and weekly timing on the IGF-I value as measured using the capillary blood spot method was analysed. A 3-way analyses of variance (ANOVA) was performed with patient, day and daily timing as factors after appropriate transformation to obtain normally distributed parameters. The interaction day*time was tested and kept in the model only if p-value<0.1. Parameter estimates from the statistical model are presented as least squares means for the categories of daily timing (Morning and Evening) and weekly timing (Week 21, Week 22 and Week 23). The values reported for Week 21, 22, and 23 represent the average IGF-I levels from the morning and evening samples at each week. The values reported for Evening represent the Evening IGF-I levels averaged across Weeks 21, 22, and 23, and similarly for the Morning values.|At Weeks 21, 22 and 23|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data.|||ng/mL||95% Confidence Interval|Least Squares Mean
2836795|NCT00234533|Primary|Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples|"Fingertip capillary blood was collected using filter paper cards for the assay of capillary blood spot IGF-I in line with the monitoring recommendations of the Lawson Wilkins Paediatric Endocrine Society (LWPES) for treatment with recombinant GH therapy in children.~Capillary IGF-I assays were performed by the patient at home one day per week during Weeks 21, 22 and 23 only (same week day). The samples were scheduled in the evening prior to the injection of NutropinAq and between 7:00 and 9:00 the following morning. An extended window from 6:00 to 12:00 was allowed for defining protocol deviations.~The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients was assessed. IGF-I measurements for the morning and evening sampling are presented."|At Weeks 21, 22 and 23|The ITT Population consisted of all treated patients (enrolled patients who received at least one injection of treatment) and who provided any follow-up data. Only evaluable subjects with an assessment at the specified timepoint were included in each individual analysis.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2836816|NCT00234104|Primary|Body Weight|The body weight change from baseline following final trial drug administration|Baseline, at the time of final trial drug administration|1 Subject of Placebo arm who experienced a serious adverse event was excluded from efficacy analysis set because the emergency code was broken.|||Kg||Standard Deviation|Mean
2836817|NCT00234078|Post-Hoc|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Week 12|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. The CFB in the LGCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett's t-test.|Baseline, 12weeks|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis|||scores on a scale||Standard Deviation|Mean
2836818|NCT00234078|Post-Hoc|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Week 12|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The CFB in the FCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett's t-test|Baseline, 12week|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis|||scores on a scale||Standard Deviation|Mean
2836819|NCT00234078|Primary|Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)|POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 12 weeks||||scores on a scale||Standard Deviation|Mean
2836820|NCT00234078|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|baseline, 12 weeks||||scores on a scale||Standard Deviation|Mean
2836821|NCT00234065|Other Pre-specified|Number of Patients With First Occurrence of Haemorrhagic Event|The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
2836822|NCT00234065|Secondary|Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
2836823|NCT00234065|Secondary|Number of Deaths From Any Cause|Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
2836824|NCT00234065|Secondary|Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|||participants|||Number
2836825|NCT00234065|Secondary|Number of Patients With First Recurrence of Cerebral Infarction||From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])||||participants|||Number
2836826|NCT00234065|Primary|Numbers of Patients With First Occurence of Stroke|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|||participants|||Number
2836827|NCT00234052|Post-Hoc|Overall Survival Rate at 6, 12, 18, and 24 Months|"Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment will be defined as the percentage of patients with documentation of status of alive at the following timepoints from registration to the study:~6 months 12 months 18 months 24 months"|6, 12,18, and 24 months from treatment initiation||||percentage of patients alive|||Number
2836873|NCT00233324|Secondary|Received Surfactant Treatment|Received any surfactant treatment.|From birth through 120 days of life.|1312 participants had known surfactant treatment. 4 were excluded due to unknown surfactant treatment: 2 infants in the low oxygen group, 2 infants in the high oxygen group.|||Participants|||Count of Participants
2836828|NCT00234052|Post-Hoc|Progression Free Survival at 6, 12, 18, 24 Months|"Progression Free Survival (PFS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined as the percentage of patients without progression at the following time points from registration to the study:~6 months 12 months 18 months 24 months."|6, 12,18, and 24 months from treatment initiation|One patient received less than one cycle and was determined to not be evaluable for this objective.|||percentage of patients with PFS|||Number
2836829|NCT00234052|Secondary|Duration of Response|Duration of Response for patients treated with the combination of carboplatin, pemetrexed and bevacizumab is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date of documented progressive disease.|From documentation of response, every two cycles (1 cycle = 21 days) until progressive disease with range of cycles completed 1-51.|Patients with response were included in this outcome measure.|||Months||95% Confidence Interval|Median
2836830|NCT00234052|Secondary|Overall Survival Rate|Overall Survival (OS) Rate of carboplatin, pemetrexed and bevacizumab combination treatment is defined from the time of registration to the study until death from any cause. Patients that are lost to follow up will be censored from last documentation of survival status.|During treatment and then every 3 months x 2 years, then every 6 months x 3 years or until death.||||Months||95% Confidence Interval|Median
2836831|NCT00234052|Secondary|Toxicity of Carboplatin, Pemetrexed and Bevacizumab Combination Treatment|"To characterize the toxicity profile of carboplatin, pemetrexed and bevacizumab combination treatment.~Toxicity data will be collected from initiation of treatment, every cycle, until 30 days post last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). Only toxicity determined to be a least possibility related to at least one study drug and grade 3 or 4 was collected for this outcome measure.~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|From treatment initiation, at the beginning of each cycle where one cycle equals 21 days until 30 days post treatment (range of cycles 1-51)|This includes AEs observed before there was an amendment of the protocol to exclude patients with histories of diverticulitis or clinically significant diverticular disease. Any patient that received one dose of study drug is evaluable for this objective.|||Participants|||Count of Participants
2836832|NCT00234052|Secondary|Overall Response Rate|"Overall Response Rate (ORR) of patients treated with carboplatin, pemetrexed, and bevacizumab combination is defined as the number of patients who's best response is a Complete Response (CR) plus Partial Response (PR)as recorded from the start of treatment until disease progression as assessed by RECIST 1.0.~CR=Disappearance of all target lesions for a minimum of 4 weeks. PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions for a minimum of 4 weeks, taking as reference the baseline sum LD. No simultaneous increase in the size of any lesion or the appearance of a new lesion may occur."|Every two cycles until disease progression. Median follow up of 13 months (range 0.8 to 34.4 months)|One patient received less than one cycle and was determined to not be evaluable for this outcome measure.|||Participants|||Count of Participants
2836833|NCT00234052|Primary|Median Progression Free Survival|Progression Free Survival (PFS) in patients treated with the combination of carboplatin, pemetrexed and bevacizumab is defined as the time from registration to the time of documented disease progression or death from any cause. Patients that were lost to follow up or withdrew consent were censored at that point.|Approximately every 3 weeks until disease progression or death. Median follow up of 13 months (range 0.8 to 34.4 months)||||Months||95% Confidence Interval|Median
2836834|NCT00234039|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2836835|NCT00234039|Secondary|Recurrence-free Survival (RFS)|Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.|1 year|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2836836|NCT00234039|Primary|Complete Response Rate at the End of Induction|Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy|Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2836837|NCT00234039|Secondary|Overall Survival (OS)|Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.|1 year|All eligible patients who started treatment were included in the analysis|||percentage of participants|||Number
2836838|NCT00233987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2836839|NCT00233987|Secondary|Overall Survival|Measured from date of registration to date of death due to any cause or last contact|At day 60, then every 6 months for 2 years, then annually for a total of 7 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2836894|NCT00232739|Secondary|Percentage of Participants Who Achieved Lesion Success at Post-procedure|Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method|At post-procedure|Number of Participants without missing lesion success data|||Percentage of participants||95% Confidence Interval|Mean
2836840|NCT00233987|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded.|||participants|||Number
2836841|NCT00233987|Primary|2-year Progression-free Survival|Measured from date of randomization to date of first observation of progressive disease, or death due to any cause|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2836842|NCT00233948|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 3 cycles of treatment, up to 2 years.|Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.|||participants|||Number
2836843|NCT00233948|Primary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. If PK analysis of 3 patients treated at 4250 mg bid and 3 patients at 3000 mg bid confirms that the first dose area under the curve and Cmax of nelfinavir does not increase appreciably at doses greater than 1875 mg BID then 3000 mg BID will be deemed the MTD.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg|||Number
2836844|NCT00233948|Primary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
2836845|NCT00233519|Primary|The Number of Study Participants Who Safely Tolerated Somatokine|Safety and tolerability was measured via interval laboratory studies,electrocardiograms, echocardiograms, ultrasounds of the abdomen and pelvis, dual energy x-ray absorptiometry (DEXA) studies, chest and neck x-rays, and serial physical examinations. The participants had six inpatient evaluations at the University of Rochester General Clinical Research Center (Weeks 0, 8, 16, 24, 28, and 40) and nine outpatient evaluations. Patients also completed side effects diaries to record any adverse events in the interval time between inpatient and outpatient evaluations.|24 weeks||||participants|||Number
2836846|NCT00233480|Secondary|Cardiac Troponin I (cTnI)|Participants with cTnI ≥0.04 ng/mL|Baseline, Three months||||percent of participants|||Number
2836847|NCT00233480|Secondary|High-sensitivity C-reactive Protein (hsCRP) as a Cardiac Biomarker||Baseline, Three months||||mg/L||Full Range|Mean
2836848|NCT00233480|Secondary|Cardiac Biomarker Level BNP|B-type natriuretic peptide, measured pg/mL at baseline and post-treatment|Baseline, 3 months||||pg/mL||Full Range|Mean
2836849|NCT00233480|Secondary|Left Ventricular End-diastolic Dimension (LVEDD)|The end-diastolic dimension of the left ventricle (in mm) was measured with 2D echocardiography performed by experienced technicians using Acuson Sequoia Echocardiography System|Baseline and three months||||Millimeters (mm)||Standard Error|Mean
2836850|NCT00233480|Primary|Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography)||Baseline and three months|Eighteen subjects had baseline and final sympathetic microneurographic tracings that were technically adequate for analysis. Reasons for inadequate microneurographic tracing were: 1) inability of investigators to locate sympathetic nerve on baseline or final study; or 2) inability of patient to tolerate discomfort of the procedure.|||bursts per minute||Standard Error|Mean
2836851|NCT00233480|Primary|LVEF (Left Ventricular Ejection Fraction)|Left ventricular ejection fraction was assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).|baseline and three months||||percent ejection fraction||Standard Error|Mean
2836852|NCT00233454|Secondary|Overall Survival (OS)|Overall survival was assessed as the median duration of survival at the time of data cut-off, and reported with 95% confidence interval.|40 months||||months||95% Confidence Interval|Median
2836853|NCT00233454|Secondary|Overall Survival (OS)|Overall survival will be assessed after 12 cycles of treatment, with each cycle being 28 days (4 weeks) in length. 12 cycles of treatment is considered to be about 11 months.|11 months||||participants|||Number
2836854|NCT00233454|Primary|Subjects With Clinical Response [Partial Response (PR) + Complete Response (CR)]|"Clinical Response [PR + CR] will be assessed after 2 cycles of treatment, with each cycle being 28 days (4 weeks) in length.~Except as otherwise noted, the minimum criteria for PR is improvement by at least 50% from the baseline value towards the indicated value for one or more of the criteria below:~BONE MARROW & BLOOD~ANC <1000/uL~Hb <10 g/dL~Platelets >100,000/uL LIVER~If hepatomegaly with ascites, decrease in frequency of paracenteses by 50%~Elevated enzyme levels > upper limit of normal (ULN)~Hypoalbuminemia < ULN~Portal hypertension > ULN SPLEEN~If palpable splenomegaly with hypersplenism/thrombocytopenia, hypersplenism markers improved GI TRACT~If malabsorption with hypoalbuminemia and/or weight loss, albumin improved BONES~If huge osteolyses or/and severe osteoporosis with pathologic fractures, partial resolution of osteolyses~Subjects with PR or greater continue, those without response discontinue."|2 months||||participants|||Number
2836855|NCT00233402|Secondary|Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.||Day 0||||percentage of participants||95% Confidence Interval|Number
2836856|NCT00233402|Secondary|Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.|"The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).~The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately."|Day 0||||Percetange of lesion||95% Confidence Interval|Number
2836857|NCT00233402|Primary|Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.||9 months|ITT population|||percentage of participants|||Number
2836858|NCT00233402|Primary|Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light||Day 0|Analysis was based on ITT population|||percentage of participants||95% Confidence Interval|Number
2836859|NCT00233324|Other Pre-specified|Apgar Scores at 5 Minutes|"Apgar stands for Appearance, Pulse, Grimace, Activity, and Respiration and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth."|5 minutes after birth.|All 1316 participants had APGAR scores at 5 minutes.|||scores on a scale||Inter-Quartile Range|Median
2836860|NCT00233324|Secondary|Cerebral Palsy|Incidence of cerebral palsy.|18-22 months|990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.|||Participants|||Count of Participants
2836861|NCT00233324|Secondary|Necrotizing Enterocolitis (NEC)|Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.|From birth through first 120 days of life.|1290 participants had known NEC statuses. 26 were excluded due to missing NEC data: 13 infants in the low oxygen group, 13 infants in the high oxygen group.|||Participants|||Count of Participants
2836862|NCT00233324|Secondary|Received Postnatal Steroids|Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.|From birth through first 120 days of life.|1280 participants had information regarding whether they received postnatal steroids. 36 participants were excluded due to missing data: 18 infants in the low oxygen group, 18 infants in the high oxygen group.|||Participants|||Count of Participants
2836863|NCT00233324|Secondary|Blindness in at Least One Eye|Blindness in at least one eye by 18-22 months of life.|18-22 months|990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.|||Participants|||Count of Participants
2836864|NCT00233324|Secondary|Pulse Oximetry Values > 90%|Percentage of time spent above 90% oxygen saturation.|From birth through first 120 days of life.|90 were excluded due to incomplete data: 48 from the low oxygen saturation group and 42 from the high oxygen saturation group.|||percentage of time||Inter-Quartile Range|Median
2836865|NCT00233324|Secondary|Duration of Oxygen Supplementation|The length of time in days that a participant had oxygen supplementation.|From birth through first 120 days of life.|1078 participants survived to discharge and they all had information available regarding the duration of their oxygen supplementation.|||days||Inter-Quartile Range|Median
2836866|NCT00233324|Secondary|Endotracheal Intubation|Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.|Delivery Room, post-delivery|1312 participants had non-missing data on whether they experienced endotracheal intubation. 4 participants were excluded due to missing information: 2 infants in the low oxygen group, 2 infants in the high oxygen group.|||Participants|||Count of Participants
2836867|NCT00233324|Secondary|Threshold Retinopathy of Prematurity (ROP) Requiring Surgery|Diagnosis of retinopathy of prematurity which resulted in requiring surgery.|From birth through first 120 days of life.|997 surviving participants with ROP data were included. 319 total participants were excluded due to death (N=224) or missing ROP data (N=95): 171 in the low oxygen group, 148 in the high oxygen group.|||Participants|||Count of Participants
2836868|NCT00233324|Secondary|Periventricular Leukomalacia (PVL)|Increased echogenicity or cysts in periventricular region.|From birth through first 120 days of life.|1272 participants had known PVL statuses. 44 were excluded due to unknown PVL status: 23 infants in the low oxygen group, 21 infants in the high oxygen group.|||Participants|||Count of Participants
2836869|NCT00233324|Secondary|Severe Intraventricular Hemorrhage (IVH)|There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV.|From birth through first 120 days of life.|1270 participants had known IVH grades. 46 were excluded due to unknown IVH status: 24 infants from the low oxygen group, 22 infants from high oxygen group.|||Participants|||Count of Participants
2836870|NCT00233324|Secondary|Death|Participants who died by their follow-up visit at 18-22 months.|18-22 months|1281 participants with confirmed deaths or survivals by follow-up. 35 were excluded due to incomplete follow-up visits: 21 in low oxygen group, 14 in high oxygen group.|||Participants|||Count of Participants
2836871|NCT00233324|Secondary|Physiological Bronchopulmonary Dysplasia|Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen <27% and had majority saturation >90%, or they were receiving effective oxygen 27-30% and had majority saturation >96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge.|36 weeks post menstrual age.|1108 participants survived to 36 weeks and had BPD information. 208 participants did not survive to 36 weeks and were excluded: 114 from the low oxygen group, 94 from the high oxygen group.|||Participants|||Count of Participants
2836872|NCT00233324|Secondary|Number of Participants With Air Leaks|Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.|From birth through first 14 days of life.|All 1316 participants had data on incidence of air leaks.|||Participants|||Count of Participants
2836874|NCT00233324|Secondary|Survival Without Ventilation|Surviving the first 7 days of life without any need for ventilation by day 7|From birth through first 7 days of life.|1307 participants had known survival and ventilation statuses. 9 participants were excluded due to unknown ventilation status from birth through 7 days of life: 6 infants in the lower oxygen group, 3 infants in the high oxygen group.|||Participants|||Count of Participants
2836875|NCT00233324|Secondary|Duration of Mechanical Ventilation|The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.|Entire NICU stay, up to 120 days|1078 participants survived to discharge and they all had information available for regarding use of mechanical ventilation.|||days||Inter-Quartile Range|Median
2836876|NCT00233324|Secondary|Death or Neurodevelopmental Impairment||18-22 months||||participants|||Number
2836877|NCT00233324|Primary|Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)||55 weeks|49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome|||participants|||Number
2836878|NCT00233324|Primary|Survival Without Bronchopulmonary Dysplasia (BPD)||36 weeks||||Participants|||Number
2836879|NCT00233103|Primary|Depression at End of Treatment|"Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention.~The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression."|end of treatment, average of 10 weeks||||units on a scale||Standard Deviation|Mean
2836880|NCT00233103|Secondary|Life-3|Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7.|Immediately post-intervention at 10 weeks||||units on a scale||Standard Deviation|Mean
2836881|NCT00233103|Secondary|BAI|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression|Immediately post-intervention||||units on a scale||Standard Deviation|Mean
2836882|NCT00233103|Primary|Depression at Baseline|"The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.~Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline."|baseline||||units on a scale||Standard Deviation|Mean
2836883|NCT00233090|Secondary|Quality of Life|quality of life|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836884|NCT00233090|Secondary|Participation|participation|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836885|NCT00233090|Secondary|Health Status|health status|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836886|NCT00233090|Secondary|Sleep Quality|sleep quality|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836887|NCT00233090|Secondary|Pain|pain|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836888|NCT00233090|Secondary|Mood|mood|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836889|NCT00233090|Secondary|Cognitive Performance|Cognitive performance|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836890|NCT00233090|Primary|Fatigue|Self-report of fatigue|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.||||||
2836891|NCT00233064|Primary|Number and Percentage of Participants With Immune Reactivity|Presence of anti-palivizumab antibodies|Day 240-300 follow up|Participants who received at least 2 doses of study drug and had at least 1 blood sample collected (at baseline or Study Day 240-300) were included in the analysis. This included 206 subjects in Arm 1 and 200 subjects in Arm 2. Of these subjects, 191 (Arm 1) and 188 (Arm 2) had adequate blood samples for analysis. This analysis was per protocol.|||Participants|||Number
2836892|NCT00232739|Secondary|Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge|Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay|From post-procedure to hospital discharge|Number of participants without missing procedure success data|||Percentage of participants||95% Confidence Interval|Mean
2836893|NCT00232739|Secondary|Percentage of Participants Who Achieved Device Success at Post-procedure|Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used|At post-procedure|All participants|||Percentage of participants||95% Confidence Interval|Mean
2838658|NCT00201240|Secondary|Chronic Graft Versus Host Disease (GVHD)|Incidence and severity of chronic GVHD will be scored according to the BMT CTN MOP.|Year 2||||percentage of participants||95% Confidence Interval|Number
2836897|NCT00232739|Secondary|Average Stent Obstruction Volume at Post-procedure|Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected|At post-procedure|Number of participants who had Stent Obstruction Volume data at post-procedure|||mm3||Standard Deviation|Mean
2836898|NCT00232739|Secondary|Average Lumen Volume (mm3) at Post-procedure||At Post-procedure|The number of participants who had lumen volume data at post-procedure|||mm3||Standard Deviation|Mean
2836899|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure|TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.|||Percentage of participants||95% Confidence Interval|Mean
2836900|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.|TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.|||Percentage of participants||95% Confidence Interval|Mean
2836901|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.|"TLR was defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel."|From post-procedure to 6 months and 9 months|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.|||Percentage of participants||95% Confidence Interval|Mean
2836902|NCT00232739|Secondary|Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.||From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.|||mm||Standard Deviation|Mean
2836903|NCT00232739|Secondary|Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.|In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.|||Percentage of participants||95% Confidence Interval|Mean
2836904|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up|The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure to 4 years|The number of participants who had four years post-procedure follow up or who had at least one event prior to the end of follow-up.|||Percentage of participants||95% Confidence Interval|Mean
2836905|NCT00232739|Primary|Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure|In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.|||Percentage of participants||95% Confidence Interval|Mean
2836906|NCT00232596|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.|||participants|||Number
2836907|NCT00232596|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 18 minus the value at Baseline.|Baseline (Week -7 through Week 0), Weeks 10 and 18|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.|||milliliters||Full Range|Median
2836908|NCT00232596|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 24|Safety Population|||participants|||Number
2836909|NCT00232596|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 24|Safety Population|||participants|||Number
2836932|NCT00232583|Secondary|Quality of Life Survey (QoL) - Social or Vocational Worry|Social or vocational worry was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.|72 months||||score on a scale||Standard Deviation|Mean
2836910|NCT00232596|Secondary|Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 6, 10, and 18|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Participants who were cognitively impaired and could not complete the QOLIE-31-P assessment were not analyzed. The number of participants analyzed differs by week because not all participants completed the questionnaire at the indicated weeks.|||scores on a scale||Standard Deviation|Mean
2836911|NCT00232596|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had a PGI score were analyzed.|||scores on a scale||Standard Deviation|Mean
2836912|NCT00232596|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had CGI-I scores were analyzed.|||scores on a scale||Standard Deviation|Mean
2836913|NCT00232596|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in the DB period x 100%.|Week 7 through Week 18|ITT Population for EMEA review|||percentage of days||Full Range|Median
2836914|NCT00232596|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.|||percentage of days||Full Range|Median
2836915|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 7 through Week 18|ITT Population for EMEA review|||participants|||Number
2836916|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.|||participants|||Number
2836917|NCT00232596|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
2836918|NCT00232596|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review.|||participants|||Number
2836919|NCT00232596|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review|||participants|||Number
2836920|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
2837118|NCT00229957|Secondary|HOME Falls and Accident Screening Tool (FAST)|This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.|baseline, 15 months||2009-08-31|08/2009||||
2836921|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data were included in the No reduction category."|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
2836922|NCT00232596|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review|||percent change in seizure frequency||Full Range|Median
2836923|NCT00232596|Secondary|Number of Participants Who Were Responders and Non-responders in the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 18|ITT Population for FDA review|||participants|||Number
2836924|NCT00232596|Primary|Number of Participants Who Were Responders and Non-responders in the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 7 through Week 18|Intent-to-Treat (ITT) Population for European Medicines Agency (EMEA) review: all randomized participants who received at least one dose of study drug in the Maintenance Phase and had at least one seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase|||participants|||Number
2836925|NCT00232596|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 1 through Week 18|Intent-to-Treat (ITT) Population for Food and Drug Administration (FDA) review: all randomized participants (par.) who received at least one dose of the study drug. Only par. with baseline and post-baseline measures were analyzed. Two par. in each treatment arm did not have post-baseline measures and were thus not included in this analysis.|||percent change in seizure frequency||Full Range|Median
2836926|NCT00232583|Secondary|Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment|Willingness to continue insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.|72 months|"Data were not collected from participants in the Metfomin, Pioglitazone & Glyburide Arm/Group since patients did not receive insulin."|||score on a scale||Standard Deviation|Mean
2836927|NCT00232583|Secondary|Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment|Satisfaction with insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.|72 months|"Data were not collected from participants in the Metfomin, Pioglitazone & Glyburide Arm/Group since patients did not receive insulin."|||score on a scale||Standard Deviation|Mean
2836928|NCT00232583|Secondary|Quality of Life Survey (QoL) - Social Stigma|Social stigma was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1- strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.|72 months||||score on a scale||Standard Deviation|Mean
2836929|NCT00232583|Secondary|Quality of Life Survey (QoL) - Lifestyle Flexibility|Lifestyle flexibility was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.|72 months||||score on a scale||Standard Deviation|Mean
2836930|NCT00232583|Secondary|Quality of Life Survey (QoL) - Glycemia Control Perception|Glycemia control perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled.|72 months||||score on a scale||Standard Deviation|Mean
2836931|NCT00232583|Secondary|Quality of Life Survey (QoL) - Hypoglycemia Fear|Hypoglycemia fear was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry|72 months||||score on a scale||Standard Deviation|Mean
2837011|NCT00231894|Primary|Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample||pre-treatment and during 3 months of treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of triglycerides at baseline and three months followup. See table 2 of published paper given in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2836933|NCT00232583|Secondary|Quality of Life Survey (QoL) - Treatment Impact|Treatment impact was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|72 months||||score on a sale||Standard Deviation|Mean
2836934|NCT00232583|Secondary|Quality of Life Survey (QoL) - Treatment Satisfaction|Treatment satisfaction was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|72 months||||score on a scale||Standard Deviation|Mean
2836935|NCT00232583|Secondary|Quality of Life Survey (QoL) - Current Health Perception|Current health perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.|72 months||||score on a scale||Standard Deviation|Mean
2836936|NCT00232583|Secondary|Inflammatory Markers - PAI-1|Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)|72 months||||IU/L||Standard Deviation|Mean
2836937|NCT00232583|Secondary|Inflammatory Markers -Fibrinogen|Inflammatory markers - Fibrinogen|72 months||||mg/dL||Standard Deviation|Mean
2836938|NCT00232583|Secondary|Inflammatory Markers - hsCRP|Inflammatory markers - hsCRP (C reactive protein)|72 months||||mg/L||Standard Deviation|Mean
2836939|NCT00232583|Secondary|Weight|Body Weight|72 months||||kg||Standard Deviation|Mean
2836940|NCT00232583|Secondary|Bet-cell Function Measured by Disposition Index|Disposition index was measured by multiplying the insulin secretion (C-peptide AUC/C-peptide AUC glucose) by the Matsuda index. Disposition index reflects the beta-cell function adjusted for total body insulin sensitivity|72 months||||index||Standard Deviation|Mean
2836941|NCT00232583|Secondary|Insulin Sensitivity as Measure be Matsuda Index|C-peptide-based Matsuda index using following formula: Matsuda index = 500,00 / root square [(fasting c-peptide x fasting glucose x 333) x (average c-peptide 0-120 mins x average glucose 0-120 mins x 333). Higher the Matsuda index, better the insulin sensitivity.|72 months||||index||Standard Deviation|Mean
2836942|NCT00232583|Primary|Beta-cell Function - C-peptide AUC (Area Under the Curve)|C-peptide AUC during a 3-hours mixed meal challenge testing|72 months||||ng*min/mL||Standard Deviation|Mean
2836943|NCT00232557|Secondary|Participants With Oral Corticosteroid Use|Number of participants found to have any use of oral corticosteroids related to asthma during one year|1 year||||participants|||Number
2836944|NCT00232557|Primary|Participants With Unscheduled Asthma-related Visits|Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.|1 year||||participants|||Number
2836945|NCT00232544|Secondary|Daytime Vigilance|A measure of behavioral alertness. Specifically the metric we used was the mean reaction time, the time it took for a subject to respond to a visual stimulus (light displayed on a screen at random intervals) by hitting a button.|12 months||||ms||95% Confidence Interval|Mean
2836946|NCT00232544|Primary|Objective CPAP Use|Mean nightly hours of CPAP use over 12 months|12 months||||log(hours/night)||95% Confidence Interval|Mean
2836947|NCT00232505|Secondary|Progression-Free Survival|Time to disease progression of cetuximab or cetuximab + carboplatin as indicated by radiographic assessment|Every four months until progression, death of any cause, or end of data collection up to 40 months||||participants|||Number
2836948|NCT00232505|Secondary|Overall Survival|Subjects will be contacted every 4 months after discontinuation of active treatment to assess survival.|Every four months until death of any cause or end of data collection up to 40 months||||participants surviving|||Number
2836949|NCT00232505|Primary|Overall Disease Response Rate|Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|5 years||||Participants|||Count of Participants
2836950|NCT00232479|Secondary|Safety and Tolerability|the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability|from the first dose of chemotherapy until surgery which was approximately 16 weeks.|48 patients signed an initial informed consent. 2 withdrew consent before treatment. 2 withdrew after starting treatment. Only 44 are evaluable for primary endpoint because 2 did not go for surgery.|||participants|||Number
2836951|NCT00232479|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.|determined at the time of surgery which is approximately 16 weeks from the beginning of treatment|48 patients signed consent but only 44 were evaluable. To be evaluable the patient must have received at least one dose of chemo and then had surgery. Two patients withdrew consent before treatment and two patients did not have surgery. So 44 are evaluable for the primary endpoint|||participants|||Number
2836996|NCT00232141|Secondary|Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores|"Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from no pain (0) to pain as bad as you can imagine (10)"|Baseline, Week 14|ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836952|NCT00232180|Secondary|Number of Participants With New Onset Diabetes Mellitus (DM)|The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of diabetes mellitus at baseline and “n” signifies participants evaluated at that time point.|||participants|||Number
2836953|NCT00232180|Secondary|Number of Participants With New Onset Atrial Fibrillation or Flutter|New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of atrial fibrillation at baseline and “n” signifies participants evaluated at that time point.|||participants|||Number
2836954|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)|First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836955|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)|First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836956|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)|First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836957|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)|First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836958|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836959|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836960|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)|First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836997|NCT00232141|Secondary|Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales|Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).|Baseline, Week 14|ITT population|||score on scale||Standard Error|Least Squares Mean
2836961|NCT00232180|Secondary|Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836962|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)|Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836963|NCT00232180|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)|First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836964|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)|Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836965|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836966|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)|Death due to any cause.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836967|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.|||participants|||Number
2836968|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol.|||participants|||Number
2836981|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2837119|NCT00229957|Secondary|Falls and Injuries|self-reported number of falls in last 6 months|baseline, 15 months||2009-08-31|08/2009||||
2836969|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)|Full analysis set (FAS) using intent-to-treat (ITT) principle: All randomized participants, followed for mortality, other major endpoints for duration of double blind treatment period, regardless of compliance with study drug and protocol. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2836970|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table|Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).|Baseline-Week 14 (Endpoint)|ITT Population|||participants|||Number
2836971|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table|Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)|Baseline-Week 14 (Endpoint)|ITT Population; Pregabalin weight range- 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived. Placebo weight range- 2.83, 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived|||participants|||Number
2836972|NCT00232141|Secondary|Gracely Pain Scale Score|The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.|Week 14|ITT Population|||score on scale||Standard Deviation|Mean
2836973|NCT00232141|Secondary|Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population|||participants|||Number
2836974|NCT00232141|Secondary|Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population|||participants|||Number
2836975|NCT00232141|Secondary|Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks|Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population|||participants|||Number
2836976|NCT00232141|Secondary|Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain|Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population|||participants|||Number
2836977|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836978|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836979|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836980|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2837012|NCT00231842|Primary|Cycles With Hematologic Toxicities|Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.|2 years||||Cycles|||Number
2836982|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836983|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836984|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836985|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836986|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836987|NCT00232141|Secondary|Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836988|NCT00232141|Secondary|Shift in Hospital Anxiety and Depression (HADS) Subscales|Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.|Baseline, Week 14|ITT Population|||participants|||Number
2836989|NCT00232141|Secondary|Change in NRS-Sleep Interference Scores|Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.|Baseline, Weeks 1-14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836990|NCT00232141|Other Pre-specified|Duration Adjusted Average Change From Baseline in NRS Pain Scores|Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed).|Weekly: Week 1 - Week 14|ITT Population|||score on scale||Standard Error|Least Squares Mean
2836991|NCT00232141|Secondary|Change in Quantitative Assessment of Neuropathic Pain (QANeP)|Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836992|NCT00232141|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836993|NCT00232141|Secondary|Patient Global Impression of Change (PGIC) Rating|PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Baseline, Week 14, Endpoint-LOCF|ITT Population|||participants|||Number
2836994|NCT00232141|Secondary|Categorized Patient Global Impression of Change (PGIC)|The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).|Baseline, Week 14|ITT Population|||participants|||Number
2836995|NCT00232141|Secondary|Change From Baseline for NRS-Sleep Interference Scores|11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])|Baseline, Week 14|ITT Population|||score on scale||Standard Error|Least Squares Mean
2836998|NCT00232141|Secondary|Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices|"Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales sleep adequacy, quantity of sleep and optimal sleep low scores reflect impairment."|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2836999|NCT00232141|Other Pre-specified|Responders - Decreases of at Least 30% in Mean Weekly Pain Score|Number of subjects that experienced at least 30% decrease in mean weekly pain.|Weeks 1-14 endpoint BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward|||participants|||Number
2837000|NCT00232141|Other Pre-specified|Responders- Decreases of at Least 50% in Mean Weekly Pain Score|Number of subjects that experienced at least a 50% decrease in mean weekly pain.|Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward|||participants|||Number
2837001|NCT00232141|Other Pre-specified|Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)|Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)|Baseline, Weeks 1 - 14 and Endpoint-BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2837002|NCT00232141|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 14|ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose & had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).|||score on scale||Standard Error|Least Squares Mean
2837003|NCT00231894|Secondary|Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site||pretreatment and during 3 months of drug treatment|Data is from participants at china. site N=10, Pioglitazone =5, Placebo =5, who had values of HDL at baseline and three months followup. See of published paper and its supplementary data paper cited in reference for further details|||mg/dL||Standard Error|Least Squares Mean
2837004|NCT00231894|Secondary|2 Hour Glucose From Glucose Tolerance Test China Sample|difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment|between baseline and 3 months of study drug treatment|Data is from participants at china site N=10, Pioglitazone =5, Placebo =5, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2837005|NCT00231894|Secondary|Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample||pretreatment and during 3 months of drug treatment|Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of triglycerides at baseline and three months followup. See published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2837006|NCT00231894|Secondary|Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample||pretreatment and during 3 months of drug treatment|Data is from participants at China site N=10, Pioglitazone =5, Placebo =5, who had values of fasting glucose at baseline and three months follow-up. See published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2837007|NCT00231894|Secondary|Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample|The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measure cognitive function in patients with schizophrenia. Range for list learning sub-score is 0 to 20 . Higher values indicate better performance. For change score (3 months -baseline) positive values indicate improved performance for this cognitive function and negative values indicate poorer performance on this cognitive function.|pre-treatment and 3 months of treatment|Data is from participants at U.S. sites N=43, Pioglitazone =25, Placebo =18, who had scores of RBANS List learning at 2-hour point at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||Units on RBANS scale||Standard Error|Least Squares Mean
2837008|NCT00231894|Primary|2 Hour Glucose From Glucose Tolerance Test US Sample|difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment|between baseline and 3 months of study drug treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at 2-hour point in glucose tolerance test at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2837009|NCT00231894|Primary|Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample||pretreatment and during 3 months of drug treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of serum glucose at baseline and three months follow-up. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2837010|NCT00231894|Primary|Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample|serum high density lipoprotein (HDL)|pre-treatment and during 3 months of treatment|Data is from participants at U.S. sites N=44, Pioglitazone =25, Placebo =19, who had values of HDL at baseline and three months followup. See table 2 of published paper and its supplementary data paper cited in reference for further details.|||mg/dL||Standard Error|Least Squares Mean
2837120|NCT00229957|Secondary|Functional Limitations|Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.|baseline, 15 months||2009-08-31|08/2009||||
2837013|NCT00231816|Other Pre-specified|GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP|||titers||95% Confidence Interval|Geometric Mean
2837014|NCT00231816|Other Pre-specified|GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.|||titers||95% Confidence Interval|Geometric Mean
2837015|NCT00231816|Other Pre-specified|Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.|||titers||95% Confidence Interval|Geometric Mean
2837016|NCT00231816|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination|"GMFR of the VZV gpELISA antibody titers from prevaccination~to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine"|prevaccination to 4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid GMFR results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)|||ratio||95% Confidence Interval|Geometric Mean
2837017|NCT00231816|Primary|Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses|The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.|4 weeks|The primary analysis was based on the per protocol population defined as participants who had valid GMT results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP).|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2837018|NCT00231777|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.|||Participants|||Number
2837019|NCT00231777|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.|||Participants|||Number
2837020|NCT00231777|Primary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline and 24 hours|"All patients as treated (APaT) which included all patients who received active study therapy.~patients in the MK0517 40 mg treatment group were randomized but did not have at least one post-baseline laboratory test and therefore were not counted as part of the N analyzed."|||Participants|||Number
2837021|NCT00231777|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.|||Participants|||Number
2837022|NCT00231478|Secondary|Adverse Experiences|The adverse events are captured in the AE and SAE section of this database|infusion to 15 days post treatment|Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period.|||Number of participants assessed|||Number
2837023|NCT00231478|Secondary|Time to First Vomiting Episode|Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up.|0-24h after time of extubation|Evaluable Patients|||hours||Standard Error|Mean
2837024|NCT00231478|Secondary|Number of Patients With no Vomiting|No vomiting describes no emesis during the first 24 hours|0-24h after time of extubation|Evaluable Patients|||participants|||Number
2837025|NCT00231478|Primary|Number of Patients With no Vomiting|Number of patients with no vomiting is described as no emesis up to 2 hours after surgery|0-2h after end of surgery (time of extubation)|Evaluable Patients|||participants|||Number
2837026|NCT00231465|Secondary|Overall Survival (OS) Rate|OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005|||Months||95% Confidence Interval|Median
2837127|NCT00229723|Secondary|Overall Survival|Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).|Overall survival assessed at 2 years||||Percentage of participants|||Number
2837027|NCT00231465|Secondary|Progression Free Survival (PFS) Rate|PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005|||Months||95% Confidence Interval|Median
2837028|NCT00231465|Primary|Overall Response Rate (ORR)|ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Duration of time on study, an average of 19 months|Response was evaluable in 42 of the 44 patients.|||percentage of participants||95% Confidence Interval|Mean
2837029|NCT00231413|Secondary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological [basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.|At Month 2 and Month 7|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available at the specified time points.|||Participants|||Count of Participants
2837030|NCT00231413|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.|From Day 0 up to Month 12|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2837031|NCT00231413|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)|NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.|From Day 0 up to Month 12|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2837032|NCT00231413|Secondary|Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies|Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.|From Day 0 to Month 12|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2837033|NCT00231413|Secondary|Number of Subjects With Any SAEs During the Extended Safety Follow-up|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Month 12|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2837034|NCT00231413|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Month 7|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2837035|NCT00231413|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination."|During the 30-day post-vaccination period|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2837036|NCT00231413|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 7 day post-vaccination period following each dose and across doses|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented, for whom data were available at the specified time point and had symptom sheets completed.|||Participants|||Count of Participants
2837121|NCT00229957|Secondary|Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)|Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)|baseline, 15 months||2009-08-31|08/2009||||
2837037|NCT00231413|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.|During the 7 day post-vaccination period following each dose and across doses|The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented, for whom data were available at the specified time point and had symptom sheets completed.|||Participants|||Count of Participants
2837038|NCT00231413|Secondary|Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7|Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.|At Month 2 and Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2837039|NCT00231413|Secondary|Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7|Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.|At Month 2 and Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2837040|NCT00231413|Secondary|Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7|Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.|At Month 2 and Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2837041|NCT00231413|Secondary|Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7|Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.|At Month 2 and Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2837042|NCT00231413|Secondary|Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2|Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.|At Month 2|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2837043|NCT00231413|Secondary|Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2|Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.|At Month 2|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2837044|NCT00231413|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 at Month 2|Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.|At Month 2|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2837045|NCT00231413|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 at Month 2|Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.|At Month 2|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2837046|NCT00231413|Primary|Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7|Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.|At Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2837047|NCT00231413|Primary|Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7|Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.|At Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2837075|NCT00231114|Secondary|Number of Puffs of Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Puffs/7 Days||Standard Deviation|Mean
2837048|NCT00231413|Primary|Number of Seroconverted Subjects for Anti-HPV-18 at Month 7|Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.|At Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2837049|NCT00231413|Primary|Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7|Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 7|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures, seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2837050|NCT00231309|Secondary|Hospital Length of Stay|hospital length of stay of each patient enrolled, an average of 5 weeks.|inpatient hospital stay||||average days||Standard Deviation|Median
2837051|NCT00231309|Primary|Numbers of Participants With Disease-free Survival.|Evaluate the numbers of participants with disease-free survival|260 days||||participants|||Number
2837052|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 12 months|Patients who had at least 330 days clinical follow-up.|||Percentage of participants|||Number
2837053|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge|||Percentage of participants|||Number
2837054|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 30 days|Patients who had 30 days clinical follow-up.|||Percentage of Participants|||Number
2837055|NCT00231283|Primary|Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge|Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge|||Percentage of Participants|||Number
2837056|NCT00231179|Primary|Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants|"Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal)."|child age 5 years (plus or minus 1 month)||||Percentage of participants|||Number
2837057|NCT00231179|Primary|Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants|"Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal)."|at child age of 5 years (plus or minus 1 month)||||Percentage of participants|||Number
2837058|NCT00231179|Primary|Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants|"Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal)."|at child age of 5 years (plus or minus 1 month)||||percentage of participants|||Number
2837059|NCT00231179|Primary|Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants|"Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal)."|at child age of 5 years (plus or minus 1 month)|Number of mothers/caregivers evaluated at 60 month visit.|||percentage of participants|||Number
2837088|NCT00230802|Primary|Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation|The proportion of patients in each treatment arm euthyroid through gestation|9 months|proportion of patients in each treatment arm euthyroid through gestation|||participants|||Number
2837060|NCT00231179|Primary|Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)|Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).|5 years of age (plus or minus 1 month)|Number of children evaluated at 60 month visit.|||Scores on a scale||Standard Deviation|Mean
2837061|NCT00231153|Secondary|Catheter Colonization (CC)|CC was defined as a positive culture of any catheter segment >= 15 CFU (roll-plate method) or >999 CFU/ml (sonication method) or a positive blood culture drawn via the catheter where the time-to-positivity difference of catheter line vs. peripheral blood >120 minutes (catheter positive first).|study completion|MITT Among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for catheter colonization prior to death (as determined EC adjudication).|||Events|||Number
2837062|NCT00231153|Secondary|Microbiologically-confirmed LCSI|MCLCSI is a subset of EC-adjudicated LCSI for any catheter where there is (1) growth of a recognized pathogen from a culture or any purulence or exudate from the same insertion site, or (2) a positive culture of the subcutaneous segment of the catheter meeting criteria for significant colonization.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for MCLCSI prior to death (as determined by EC adjudication).|||Events|||Number
2837063|NCT00231153|Primary|Local Catheter Site Infection (LCSI)|LCSI was defined as a study catheter showing any 2 of the following criteria: erythema >= 2; edema >= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for LCSI prior to death (as determined by EC adjudication).|||Events|||Number
2837064|NCT00231114|Other Pre-specified|Hospitalizations for Respiratory Symptoms||12 Months||||Events/Subject/Year|||Number
2837065|NCT00231114|Other Pre-specified|Emergency Room Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Events/Subject/Year||Standard Deviation|Mean
2837066|NCT00231114|Other Pre-specified|Unscheduled Physician Office Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Events/Subject/Year||Standard Deviation|Mean
2837067|NCT00231114|Other Pre-specified|Days Lost From Work/School/Other Activities Due to Asthma||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Days/Subject/Year||Standard Deviation|Mean
2837068|NCT00231114|Other Pre-specified|Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids|Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent of Subjects|||Number
2837069|NCT00231114|Other Pre-specified|Rate of Severe Exacerbations Requiring Systemic Corticosteroids|Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Events/Subject/Year||Standard Deviation|Mean
2837070|NCT00231114|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
2837071|NCT00231114|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
2837072|NCT00231114|Secondary|Morning Peak Expiratory Flow (amPEF) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||L/Min||Standard Deviation|Mean
2837073|NCT00231114|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Units on a scale||Standard Deviation|Mean
2837074|NCT00231114|Secondary|Percent Days Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
2837089|NCT00230737|Primary|Peak Melatonin Level|Pharmacokinetic analysis of maximum melatonin level|day 42||||pg/ml||Standard Error|Mean
2837076|NCT00231114|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Units on a scale||Standard Deviation|Mean
2837077|NCT00231114|Secondary|Percent Symptom-Free Days (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Percent Change||Standard Deviation|Mean
2837078|NCT00231114|Primary|Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|"Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the Integrated AQLQ Score."|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.|||Units on a scale||Standard Deviation|Mean
2837079|NCT00231062|Secondary|Number of Participants Experiencing Relief of Sinus Symptoms|To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.|Week 24|All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire|||Participants|||Number
2837080|NCT00231062|Primary|Number of Participants With Adverse Events Following Sinuplasty Procedure|Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).|24 weeks|Analysis per protocol; based on subjects not lost to follow-up at 24 weeks|||Participants|||Number
2837081|NCT00231062|Primary|Number of Sinuses With Patency of Sinus Ostium After Sinuplasty|Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.|24 weeks|Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks|||Sinuses|Participants||Number
2837082|NCT00230971|Secondary|Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure|Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization|up to 6 weeks|All patients who received at least 1 dose of study drug.|||days||Standard Deviation|Mean
2837083|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
2837084|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit|ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
2837085|NCT00230971|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit|CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study drug who had clinical evidence of a complicated intra-abdominal infection (cIAI) and completed the test-of-cure (TOC) assessment of cure or failure within 8 to 44 days after the last administration of study article. Patients with an indeterminate assessment were excluded.|||participants|||Number
2837086|NCT00230802|Secondary|Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.||9 months||||participants|||Number
2837087|NCT00230802|Secondary|the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State||9 months||||participants|||Number
2837091|NCT00230282|Primary|Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)|"Response criteria as per the NCI-WG Revised Guidelines for B-CLL~Complete remission:~No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes > 1,500/uL, Platelets > 100,000/uL, Hemoglobin > 11.0 g/dL Bone marrow aspirate and biopsy normocellular with < 30% lymphocytes Absent lymphoid nodules~Partial remission:~50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value~50% reduction in lymphadenopathy and/or ≥ 50% reduction in the size of the liver and/or spleen AND one or more of the following Polymorphonuclear leukocytes > 1,500/uL or 50% improvement over baseline Platelets > 100,000/uL or 50% improvement over baseline Hemoglobin > 11.0 g/dL or 50% improvement over baseline"|24 weeks||||participants|||Number
2837092|NCT00230178|Secondary|Time to Uric Acid Control|Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.|Day 1 to Day 7|The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.|||Hours||95% Confidence Interval|Median
2837093|NCT00230178|Secondary|Plasma Uric Acid|Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values|Day 1 to Day 7|The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.|||mg*h/dL||Standard Deviation|Mean
2837094|NCT00230178|Primary|Plasma Uric Acid Responder|Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.|Day 3 through Day 7||||Participants|||Number
2837095|NCT00230126|Primary|1-year Survival Rate||12 months||||percentage of patients|||Number
2837096|NCT00230126|Primary|Time to Progression||Every 12 weeks||||months||95% Confidence Interval|Median
2837097|NCT00230126|Primary|Disease Control Rate at 12 Weeks|no progression of disease at 12 weeks from starting treatment|12 weeks||||participants|||Number
2837098|NCT00230100|Other Pre-specified|Baseline Addiction Severity Index Alcohol Composite Score for Women|The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status.|Baseline|Only women were included in this analysis.|||units on a scale||Standard Error|Mean
2837099|NCT00230100|Other Pre-specified|Baseline Drinks Per Drinking Day for Women|The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.|||Drinks per drinking day||Standard Error|Mean
2837100|NCT00230100|Other Pre-specified|Baseline Substance Use Data for Women|The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.|||Days||Standard Error|Mean
2837101|NCT00230100|Post-Hoc|Client Satisfaction for Women|"Participant satisfaction with the groups was assessed using the Client Satisfaction Questionnaire (CSQ-8) plus four additional questions about the helpfulness of the therapist, group content, and group composition. Questions were answered on a 4-point scale where 1 reflected negative feelings and 4 reflected positive feelings. Participants' scores are calculated by adding up the numbers assigned to their chosen answers. Therefore, scores can range between 12 and 48, with higher scores reflecting greater satisfaction.~The CSQ was administered at week 3, 6, 9, and 12 while participants were in treatment. Scores represent calculated averages of the group averages for week 3, week 6, week 9, and week 12."|In treatment phase (week 1-12)|Only women were included in this analysis.|||units on a scale||Full Range|Mean
2837102|NCT00230100|Secondary|Change in Mean Addiction Severity Index Alcohol Composite Score for Women|"This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.~The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity."|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||units on a scale||Standard Error|Mean
2837103|NCT00230100|Secondary|Change in Mean Number of Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||Drinks per drinking day||Standard Error|Mean
2837122|NCT00229957|Secondary|Use of Hospital Services|self report use of hospital service|baseline, 15 months||2009-07-31|07/2009||||
2837123|NCT00229957|Primary|SF-36 Physical Component|health related quality of life. Minimum: 0; Maximum 100.|15 months||||units on a scale||Standard Deviation|Mean
2837124|NCT00229931|Secondary|Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.||3 years|Data were not collected||||||
2837125|NCT00229931|Primary|Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.||3 years|Due to lack of follow up from patients, this outcome was not analyzed; data were not collected||||||
2837104|NCT00230100|Primary|Change in Mean Number of Drinking Days for Women|This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||Drinking days||Standard Error|Mean
2837105|NCT00230100|Primary|Change in Mean Days of Any Substance Use for Women|This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.|||Days of any substance use per month||Standard Error|Mean
2837106|NCT00230048|Primary|Treatment Engagement|Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.|3 months|ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services)|||participants|||Number
2837107|NCT00230048|Primary|Number of Participants With Drug Use at 3 Months|The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.|3 months|Intent to treat, treating participants lost to follow-up as positive.|||participants|||Number
2837108|NCT00230022|Primary|Motivation to Change Substance Use|An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.|One month|A total of 30 participants were included in this pilot trial, based primarily on convenience and timeframe. The primary goal was effect-size estimation, so power was not a primary concern. Last Observation Carried Forward(LOCF) was utilized for 8 participants lost to follow-up.|||units on a scale||Standard Deviation|Mean
2837109|NCT00230009|Primary|Treatment Engagement|The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).|at 3 month follow-up||||participants|||Number
2837110|NCT00230009|Secondary|Depression|Depression was measured by using the Center for Epidemiologic Studies Depression Scale (CES-D) at the 3 month follow-up. CES-D total scores can range from 0 to 60. Scores at 16 or higher indicate clinical significance. Higher scores represent higher risk for depression.|at 3 month follow-up||||units on a scale||Standard Deviation|Mean
2837111|NCT00230009|Primary|Child Abuse Potential|Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).|baseline and 3 month follow-up||||units on a scale||Standard Deviation|Mean
2837112|NCT00230009|Primary|Drug Use|Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.|||units on a scale||Standard Deviation|Mean
2837113|NCT00230009|Primary|Alcohol Use|Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.|||units on a scale||Standard Deviation|Mean
2837114|NCT00229970|Primary|The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)|The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor|baseline over the first 60 minutes|Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)|||Liter||95% Confidence Interval|Least Squares Mean
2837115|NCT00229957|Secondary|Patient Satisfaction Questionnaire - 18 (Modified)|Patient satisfaction with the care they received. (Score range 0-5)|15 months|||||||
2837116|NCT00229957|Secondary|Physical Abilities (Strength, Balance)|Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).|baseline, 15 months||2009-08-31|08/2009||||
2837117|NCT00229957|Secondary|Self-management and Self-efficacy|Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).|baseline, 15 months||2009-08-31|08/2009||||
2837128|NCT00229723|Secondary|Progression Free Survival|Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).|Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)||||Percentage of participants|||Number
2837129|NCT00229723|Secondary|Tumour Response (Complete Response + Partial Response)|A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression||||Participants|||Number
2837130|NCT00229723|Secondary|Complete Response|A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.||||Participants|||Number
2837131|NCT00229723|Secondary|Local Disease Control Rate at 1 Year|A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).||||Participants|||Number
2837132|NCT00229723|Primary|Local Disease Control Rate at 2 Years|A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).||||Participants|||Number
2837133|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 6|Mean change in body weight from baseline at month 6|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||kg||Standard Error|Mean
2837134|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 3|Mean change in body weight from baseline at month 3|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||kg||Standard Error|Mean
2837135|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 6|Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||percent||Standard Error|Mean
2837136|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 3|Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses|||percent||Standard Error|Mean
2837137|NCT00229658|Secondary|Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Events per patient year|||Number
2837138|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Incidence (%)|||Number
2837139|NCT00229658|Secondary|The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|0-3 months|Intent-to-Treat|||Events per patient year|||Number
2837140|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat.|||Incidence (%)|||Number
2837141|NCT00229658|Secondary|The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Events per patient year|||Number
2848302|NCT00094900|Secondary|Mean Change in Prednisone Dose||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
2837142|NCT00229658|Secondary|The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)|||Incidence (%)|||Number
2837143|NCT00229658|Primary|Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|0-3 months|Intent-to-Treat|||Events per patient year|||Number
2837144|NCT00229658|Primary|Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat|||Incidence (%)|||Number
2837145|NCT00229619|Secondary|Response Rates at 12 Months (After the First Dose of Study Med)||12 months||||Participants|||Count of Participants
2837146|NCT00229619|Secondary|Response Assessment at 3 Months||3 months||||Participants|||Count of Participants
2837147|NCT00229619|Primary|Response to Rituximab|"Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.~Primary endpoint will determine immune response by evaluating changes in peripheral blood counts (platelets, absolute neutrophil count, reticulocyte count, hemoglobin) and transfusion requirements at 6 months. The response wil be will be categorized as complete, partial or no response. Subjects will be categorized as complete responders if their blood counts return to normal. Subjects will categorized as partial responders if there is an improvement in 2 or 3 of the depressed baseline blood counts."|6 months||||participants|||Number
2837148|NCT00229203|Secondary|Number of Patients With Overall Survival (OS)|Overall Survival (OS): time from the date of first infusion to the date of documented death|Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.|||percentage patients|||Number
2837149|NCT00229203|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death|Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)|||months||Full Range|Median
2837150|NCT00229203|Secondary|Time to Progression (TTP)|Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as >25 percentage increase in level of serum monoclonal paraprotein.|Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)|||months||Full Range|Median
2837151|NCT00229203|Primary|Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response|"Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: >25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.~Treatmen failure: Reappearance of serum or urinary paraprotein"|Every 2 weeks until progression or death occurs.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)|||percentage patients|||Number
2837152|NCT00228943|Primary|Objective Subject Hot Flash Frequency|Mean of the 24 hour monitoring sessions for each patient based on one 24 hour monitoring session after each intervention using an electronic monitor.|One 24 hour monitoring session per week for 8 weeks|Subjects with completed hot flash data during both arms of study.|||frequency of hot flashes||Standard Deviation|Mean
2837153|NCT00228943|Primary|Serum Tryptophan Levels|Mean serum tryptophan levels (blood draw) at the end of the nadir period.|baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours|The number of subjects with complete serum data for both arms of the study were analyzed.|||nmol/ml||Standard Deviation|Mean
2837154|NCT00228917|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination|This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.|||Subjects|||Number
2837167|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.|3 years||||percentage of subjects||95% Confidence Interval|Number
2837155|NCT00228917|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) following booster vaccination|This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.|||Subjects|||Number
2837156|NCT00228917|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after booster vaccination|This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.|||Subjects|||Number
2837157|NCT00228917|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after vaccination|This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.|||Participants|||Count of Participants
2837158|NCT00228917|Primary|Number of Subjects With Fever >39°C (Rectal Route).|Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.|During the 4-day (Day 0-3) follow-up period after booster vaccination|This analysis was performed on Booster Total Vaccinated cohort which included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets.|||Participants|||Count of Participants
2837159|NCT00228813|Primary|Incidence of Chronic Graft-versus-host Disease|The number of participants diagnosed with chronic graft-versus-host disease (GVHD).|Duration of Study (Up to two years)|Participants who survived beyond Day 100 post bone marrow transplant.|||participants|||Number
2837160|NCT00228813|Primary|Incidence of Acute Graft-versus-host Disease|The number of participants diagnosed with new acute graft-versus-host disease (GVHD).|Day 100|Participants who who developed acute GVHD was measured at Day 100 post bone marrow transplant.|||participants|||Number
2837161|NCT00228813|Primary|Engraftment Rate|The number of participants who received in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donor who reached engraftment by Day 45.|Day 45||||particpants|||Number
2837162|NCT00228566|Primary|Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings|A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.|Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.||||Participants|||Number
2837163|NCT00228553|Primary|Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)|An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year|Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.|||Participants|||Number
2837164|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.|||percentage of participants|||Number
2837165|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.|2 years|The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.|||percentage of participants|||Number
2837166|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.|1 year|The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.|||percentage of particpants|||Number
2837182|NCT00227994|Primary|Physical Function (Measured by the FIM-motor)|Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence|Measured at weeks 0 and 12||||units on a scale||Standard Deviation|Mean
2837168|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.|3 years||||percentage of subjects||95% Confidence Interval|Number
2837169|NCT00228384|Secondary|Change in Ankle-Brachial Index (ABI)|"This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.~A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal.~An outcome of a higher mean ABI is considered a success."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.|||ABI Value||Standard Deviation|Mean
2837170|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.~The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.|||Score||Standard Deviation|Mean
2837171|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.~The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.|||Score||Standard Deviation|Mean
2837172|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)|"The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire.~Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline."|3 years|Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.|||Score||Standard Deviation|Mean
2837173|NCT00228384|Secondary|Improvement in Rutherford Classification (Clinical Success)|"The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|3 years|The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.|||percentage of participants|||Number
2837174|NCT00228384|Secondary|Target Lesion Revascularization (TLR)|This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.|3 years||||percentage of participants|||Number
2837175|NCT00228384|Secondary|Target Vessel Revascularization (TVR)|This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.|3 years||||percentage of participants|||Number
2837176|NCT00228384|Secondary|Technical Success at Initial Procedure|"Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow.~The results show the percentage of study subjects that had technical success."|Time of implant procedure|The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.|||percentage of subjects|||Number
2837177|NCT00228384|Secondary|Secondary Patency|Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.|3 years||||percentage of subjects||95% Confidence Interval|Number
2837178|NCT00228384|Secondary|Primary Assisted Patency|Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.|3 years||||percentage of subjects||95% Confidence Interval|Number
2837179|NCT00228384|Primary|Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)|Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.|30 days||||percentage of subjects|||Number
2837180|NCT00228384|Primary|Efficacy: Primary Patency at Three Years|"Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention.~The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years)."|3 years||||percentage of subjects||95% Confidence Interval|Number
2837181|NCT00227994|Secondary|Medication Tolerability|Number of participants who withdrew due to side effects.|Measured throughout the study||||participants|||Number
2837183|NCT00227903|Other Pre-specified|Attendance of Treatment Outside the Study|The number of patients who attended outside treatment in the 30 days prior to each assessment.|30 days prior to assessment|all randomized participants with data availabe at time frames|||participants|||Number
2837184|NCT00227903|Other Pre-specified|Adequacy of Received Services|Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.|After prenatal care initiation|All randomized participants, 6 women had unkown attendance.|||participants|||Number
2837185|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.|||proportion of participants|||Number
2837186|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.|||proportion of participants|||Number
2837187|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.|||proportion of participants|||Number
2837188|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.|||proportion of participants|||Number
2837189|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.|||proportion of participants|||Number
2837190|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.|||proportion of participants|||Number
2837191|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.|||proportion of participants|||Number
2837192|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.|||proportion of participants|||Number
2837193|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.|||proportion of participants|||Number
2837194|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence.|||proportion of participants|||Number
2837195|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.|||proportion of participants|||Number
2837196|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence.|||proportion of participants|||Number
2837197|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine, or opioids.|Delivery to 3 months post-delivery|All randomized participants with both self-report and urine data available during the time frame.|||proportion of participants|||Number
2837198|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.|||percentage of days||Standard Deviation|Mean
2837199|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence.|||percentage of days||Standard Deviation|Mean
2837200|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.|||percentage of days||Standard Deviation|Mean
2837201|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug use or dependence.|||percentage of days||Standard Deviation|Mean
2837202|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with both self-report and urine data available.|||proportion of participants|||Number
2837203|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine, or opioids|Delivery to 3 months post-delivery|All randomized participants for whom urine data was available during the time frame.|||proportion of participants|||Number
2837204|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine||intake to delivery, an average of 21 weeks|All randomized participants for whom urine test data was available.|||proportion of participants|||Number
2837205|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with data available from the time frame.|||proportion of participants|||Number
2837206|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants|||proportion of participants|||Number
2837207|NCT00227903|Secondary|Incidence of Low Birth Weight||At delivery|Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.|||low weight births|||Number
2837208|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||delivery to 3 months post-delivery|all randomized participants with data from delivery and 3 months post-delivery|||percentage of days||Standard Deviation|Mean
2837209|NCT00227903|Secondary|Incidence of Preterm Births||At delivery|A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.|||preterm births|||Number
2837210|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|all randomized participants|||percentage of days||Standard Deviation|Mean
2837211|NCT00227877|Secondary|Any Risky Riding or Driving at 12 Months - Prague, CZR|Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic|Past-90-days at 12 months post-baseline|12-18 year old primary care patients in Prague, CZR|||Participants|||Count of Participants
2837212|NCT00227877|Secondary|Any Risky Riding or Driving at 3 Months - Prague, CZR|Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic|Past-90-days at 3 months post-baseline|12-18 year old primary care patients in Prague, CZR|||Participants|||Count of Participants
2837213|NCT00227877|Secondary|Any Risky Riding or Driving at 12 Months - New England, USA|Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England|Past-90-days at 12 months post-baseline|12-18 year old primary care patients in New England, USA|||Participants|||Count of Participants
2837214|NCT00227877|Secondary|Any Risky Riding or Driving at 3 Months - New England, USA|Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England|Past-90-days at 3 months post-baseline|12-18 year old primary care patients in New England, USA|||Participants|||Count of Participants
2837215|NCT00227877|Primary|Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic|Past-12-months at 12 months post-baseline|12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in Prague, CZR|||Participants|||Count of Participants
2837216|NCT00227877|Primary|Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic|Past-12-months at 12 months post-baseline|12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in Prague, CZR|||Participants|||Count of Participants
2837217|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR|Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic|Past-90-days at 3 months post-baseline|12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in Prague, CZR|||Participants|||Count of Participants
2837218|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic|Past-90-days at 3 months post-baseline|12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in Prague, CZR|||Participants|||Count of Participants
2837219|NCT00227877|Primary|Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA|Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA|Past-12-months at 12 months post-baseline|12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in New England, USA|||Participants|||Count of Participants
2837220|NCT00227877|Primary|Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA|Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA|Past-12-months at 12 months post-baseline|12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA|||Participants|||Count of Participants
2848303|NCT00094900|Secondary|Mean Change in Prednisone Dose||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
2837221|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA|Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.|Past-90-days at 3 months post-baseline|12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in New England, USA|||Participants|||Count of Participants
2837222|NCT00227877|Primary|Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA|Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.|Past-90-days at 3 months post-baseline|12-18 year old primary care patients who report past-12-month drug or alcohol use at baseline in New England, USA|||Participants|||Count of Participants
2837223|NCT00227760|Secondary|Progression Free Survival||Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years|Total patients|||months||95% Confidence Interval|Median
2837224|NCT00227760|Primary|Objective Response, Evaluated Using RECIST|Partial response as assessed by RECIST criteria|4 weeks|Evaluable patients|||participants|||Number
2837225|NCT00227760|Primary|Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)|4 weeks|Evaluable patients|||particip[ants|||Number
2837226|NCT00227721|Secondary|Progression-free Survival||Every two cycles|||||||
2837227|NCT00227721|Primary|Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.||Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).||||percentage of participants with CR or PR||90% Confidence Interval|Number
2837228|NCT00227617|Secondary|Biochemical Marker Response|Biochemical marker response is defined as >=50% reduction in marker or hormone(s) that were elevated at baseline. Markers/hormones tested are: Chromagranin A (CGA), 5-HIAA, Insulin, Proinsulin, C-peptide, Pancreatic polypeptide, Gastrin, Glucagon, and Vasointestinal Peptide.|From Baseline until end of treatment, up to 8 years|Percentages of participants who met criteria of a biochemical marker response are also displayed|||percentage of participants|||Number
2837229|NCT00227617|Secondary|Overall Time to Treatment Failure|Time to treatment failure is defined as the time from the initial complete or partial response to documented disease progression or death (whichever occurs first) across treatment groups and inclusive of drug holidays and estimated using Kaplan-Meier survival analysis methods|From initial complete or partial response to disease progression, up to 8 years|Intent-to-Treat population used for analysis|||months||95% Confidence Interval|Median
2837230|NCT00227617|Secondary|Overall Median Survival|The overall survival is defined as the time from baseline until death (Carcinoid, PNET, PDNEC) using Kaplan-Meier Survival analysis methods.|until death, up to 8 years|Intent-to-Treat population used for analysis|||months||95% Confidence Interval|Median
2837231|NCT00227617|Secondary|Time to Progression|Time to disease progression will be defined as the time from baseline until documented disease progression or death (whichever occurs first).|From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years|A reliable median and 95% confidence interval for time to progression could not be computed for participants with Poorly Differentiated Neuroendocrine Carcinoma (PDNEC) due to the insufficient number of participants with this condition (N=2)|||months||95% Confidence Interval|Median
2837232|NCT00227617|Primary|Best Objective Response|Best Objective Response by RECIST with Exact 95% Binomial CIs across all tumor types. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria Target lesions response + Non-Target lesions response + Evaluation of non-target lesions (Yes / No) = Overall response|From Baseline until disease progression, up to 8 years|Intent-to-Treat population used for analysis|||percentage of participants||95% Confidence Interval|Number
2837233|NCT00227617|Primary|Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment|Rates of discontinuation were calculated as counts and percentages of patients whom discontinued treatment due to adverse events possibly related to the investigational treatments not including neuropathy.|From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years|Study terminated early due to low accrual. UCSF moved its clinical research database from Velos to OnCore in July 2010 and some of the data for this study was not transferred. Results reported accurate to date|||Participants|||Count of Participants
2837234|NCT00227591|Primary|Overall Response Rate|"Response was evaluated for Anemia and Spleen:~Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess spleen size by ultrasound. Complete remission (CR): complete resolution of disease-related symptoms, splenomegaly, normalization of peripheral blood count, white cell differential and smear, and normalization of bone marrow histology. Partial remission (PR): a major or minor response in anemia or splenomegaly. Overall Response (OR)=CR + PR, assessed among eligible, treated patients."|Assessed at the end of cycle 3|6 ineligible patients were excluded from the analysis.|||Proportion of participants||95% Confidence Interval|Number
2837252|NCT00227344|Primary|Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).|Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.|within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.|||percentage of participants|||Number
2837253|NCT00227305|Primary|Change From OL Baseline in Supine Diastolic BP.|Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits|||mmHg||Standard Deviation|Mean
2837235|NCT00227539|Secondary|Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate|The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Up to 4 weeks after last dose of chemotherapy|One patient was excluded from the efficacy analysis because they were subsequently found to be ineligible. Three patients were unevaluable because they did not have have a CT scan after the completion of chemotherapy.|||Participants|||Count of Participants
2837236|NCT00227539|Secondary|Safety of Neoadjuvant Chemotherapy|The number of patients that experienced a grade 3 or higher adverse event.|Up to 4 weeks after last dose of chemotherapy||||Participants|||Count of Participants
2837237|NCT00227539|Primary|Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy|Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy|Between days 18 and 22 prior to second chemotherapy infusion|Only 19 patients had PET scans at both baseline and day 18-22 available for review.|||Participants|||Count of Participants
2837238|NCT00227370|Secondary|Ganciclovir Resistance|UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance|over the course of 300 days post randomization|intention to treat|||participants|||Number
2837239|NCT00227370|Secondary|Severity of Viremia|upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR|over the course of 300 days after randomization|intention to treat|||CMV copies/mL||Inter-Quartile Range|Median
2837240|NCT00227370|Secondary|Non-CMV Infection|non cmv opportunistic infections|over the course of 300 days after randomization|intention to treat|||participants|||Number
2837241|NCT00227370|Secondary|Biopsy Proven Acute Lung Rejection||over the course of 300 days of randomization|intention to treat|||participants|||Number
2837242|NCT00227370|Secondary|Any CMV Infection|Inclusive of CMV syndrome, disease, or infection not meeting primary end point.|over the course of 300 days post randomization|intention to treat|||participants|||Number
2837243|NCT00227370|Primary|Incidence of CMV Syndrome|CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)|over the course of 300 days after randomization|intention to treat analysis|||participants|||Number
2837244|NCT00227370|Primary|Incidence of CMV End Organ Disease|The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.|over the course of 300 days after randomization|Intention to treat analysis was conducted.|||participants|||Number
2837245|NCT00227344|Secondary|Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor||at each patients last follow-up visit|Intention to Treat (ITT)analysis of sinus rhythm was performed for subjects with available Holter Monitor data.|||percentage of participants|||Number
2837246|NCT00227344|Secondary|Health-economics Parameters (Days of Hospitalization)||at 26 months and at each patients last follow-up visit|Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.||||||
2837247|NCT00227344|Secondary|Quality of Life||at 14, 26 and 38 months|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."||||||
2837248|NCT00227344|Secondary|Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs||at 26 months and at each patients last follow-up visit|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."||||||
2837249|NCT00227344|Secondary|Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase||day 61 through 790|"Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. The upper bound of the confidence interval for the drug treatment group could not be calculated because of the high censoring rate. Therefore, NA is more appropriate in place of the maximum duration of follow-up (790.0) as the upper bound."|||days||95% Confidence Interval|Median
2837250|NCT00227344|Secondary|Percentage of Procedural Success|"Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:~Has a validation of the lesions been performed by taking 3 points inside each circular lesion?~If YES to #1, did you observe that none of them exceed 0.1 mV?~Did you observe any adverse event during the procedure?~If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success."|The day of the procedure|"Procedural success was only calculated for the catheter ablation group. Intention to Treat (ITT) analysis of procedural success for the catheter ablation group was performed using available data. The 0 below the Antiarrhythmic Drug treatment group represents not available."|||percentage of participants|||Number
2837251|NCT00227344|Secondary|Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)||within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.|||percentage of participants|||Number
2837254|NCT00227305|Primary|Change From OL Baseline in Supine Systolic BP.|Changes from OL baseline to the final visits in Supine systolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits|||mmHg||Standard Deviation|Mean
2851997|NCT00036738|Secondary|Transplant-related Mortality|Number of patients with TRM within 100 days post-transplant.|At day 100||||Participants|||Count of Participants
2837256|NCT00227305|Primary|Change From Baseline in Weight|Number with 7% or more increase (without adjustment for normal growth)|26 weeks of treatment|Number of participants is based on patients with both baseline values and post-baseline values.|||Participants|||Number
2837257|NCT00227305|Primary|Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score|"Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.~Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score."|26 weeks of treatment|Number of patients with BARS score at OL baseline and week 26.|||Participants|||Number
2837258|NCT00227305|Primary|Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score|"Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).~Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score."|OL baseline to week 26|Number of patients with SAS score at OL baseline and week 26.|||Participants|||Number
2837259|NCT00227305|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS) Score|Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).|OL Baseline to Week 26|Number of patients with CGAS score at OL baseline and week 26.|||units on a scale||Standard Deviation|Mean
2837260|NCT00227305|Secondary|Changes in Tanner Stage|"Category shift in Tanner stage. Number of subjects who experienced the change is presented.~Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger."|Change from OL baseline to week 26 in the Tanner stage|Number of patients with Tanner stagging data at OL baseline and week 26 (final visit)|||Participants|||Number
2837261|NCT00227305|Primary|Changes in Laboratory Test Results (Prolactin)|"Clinical important shift to high prolactin from open-label (OL) baseline to week 26.~High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male."|Duration of study participation||||Participants|||Number
2837262|NCT00227305|Primary|Number of Patients Withdrawn Due to AEs.|Number of subjects who withdrew from the study due to AEs.|during 26 weeks of treatment||||Participants|||Number
2837263|NCT00227305|Primary|Incidence and Nature of Adverse Events (AEs)|Number of participants that had AE which occurred from first dose date to last dose date + 30 days.|from open label to week 26+ 30 days||||Participants|||Number
2837264|NCT00227266|Secondary|Max CMAP Area (Median)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mVms||Full Range|Median
2837265|NCT00227266|Secondary|Max CMAP Area (Mean)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mVms||Standard Deviation|Mean
2837266|NCT00227266|Secondary|DEXA||0, 6mo, 12mo|||||||
2837267|NCT00227266|Primary|Modified Hammersmith Change From Baseline to 6 Months|Comparison of Modified Hammersmith Change from baseline to 6 months. Scores range from 0 to 40. A higher score indicates a better outcome. This scale is used to assess gross motor abilities of non-ambulant children with SMA in multiple research trials as well as in clinical settings.|0 months, 6 months|Analysis only pertains to cohort 1a and 1b.|||Score||Standard Deviation|Mean
2837268|NCT00227266|Post-Hoc|Modified Hammersmith Extend Baseline|"Baseline Modified Hammersmith Extend testing. The baseline test is the score they receive during their screening visits. This scale ranges from 0 to 56. A higher score indicates a better outcome.~This scale is used to assess gross motor abilities of children with SMA in multiple research trials as well as in clinical settings."|1 month prior to enrollment, at enrollment (0 months)|Analysis was determined per protocol|||Score||Full Range|Mean
2837269|NCT00227266|Secondary|Nutritional Status||-4 wks, 0, 3mo, 6mo, 12mo|||||||
2837270|NCT00227266|Secondary|Growth and Vital Sign Parameters||-4 wks, 0, 3mo, 6mo, 12mo|||||||
2837271|NCT00227266|Secondary|Ulnar MUNE||-4 wks, 0, 3 mo, 6 mo, 12 mo|||||||
2837272|NCT00227266|Secondary|Max CMAP Amplitude Median|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mV||Full Range|Median
2837273|NCT00227266|Secondary|Max CMAP Amplitude (Mean)|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)||||mV||Standard Deviation|Mean
2837274|NCT00227266|Secondary|Peds QL™ Assessment: Parental Version (All), Child Versions (> 5yrs)||-4wks, 0, 3mo, 6mo, 12mo|||||||
2837275|NCT00227266|Secondary|Quantitative Assessment of SMN mRNA From Blood Samples||-4wks or 0, 3 mo, 6 mo, 12 mo|||||||
2837278|NCT00227019|Secondary|Overall Survival (OS)|"Overall Survival (OS) is defined as the duration of time from start of treatment to deat.~Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)."|18 months||||months||95% Confidence Interval|Median
2837279|NCT00227019|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death.~Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)."|18 months||||months||95% Confidence Interval|Median
2837280|NCT00227019|Primary|Incidence of Central Nervous System (CNS) Hemorrhagic Events|Number of events of brain or central nervous system (CNS) bleeding|18 months|All participants in this study are included in the analysis population|||CNS hemorrhagic events|||Number
2837281|NCT00226941|Secondary|Survival at 5 Years|Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment.|5 years|This outcome is defined per protocol as study phase 2, which did not occur. However, data are available from the phase 1 participants (only), and are provided for completeness. This study was terminated before all patients reached 5 years from study entry. Only patients known to be alive at 5 years are reported.|||Participants|||Count of Participants
2837282|NCT00226941|Secondary|Overall Survival (OS)|Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months.|72 months|This outcome is defined per protocol as study phase 2, which did not occur. However, data are provided for phase 1 participants, for completeness. This study was terminated before all patients reached 5 years on study. Some patients are reported as the last known alive date.|||months||Standard Deviation|Mean
2837283|NCT00226941|Secondary|Time-to-Progression (TTP)|Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review.|5 years|This study was terminated before all patients reached 5 years from the date of surgical resection. Only patients that progressed are reported, and since no patients progressed in Group 2, median and range are not reportable.|||years||Full Range|Median
2837284|NCT00226941|Secondary|Tumor Downstaging at Surgical Resection|Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression.|12 to 14 weeks after radiotherapy|This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.|||Participants|||Count of Participants
2837285|NCT00226941|Secondary|Pathologic Response Rate|After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation.|12 to 14 weeks after radiotherapy|This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.|||Participants|||Count of Participants
2837286|NCT00226941|Primary|Dose-limiting Toxicity (DLT) - Number of Participants Affected|Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT.|10 weeks|All participants were formally part of the phase 1 portion of this study.|||Participants|||Count of Participants
2837287|NCT00226941|Primary|Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group|Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group.|10 weeks|All participants were formally part of the phase 1 portion of this study.|||DLTs|||Number
2837288|NCT00226811|Primary|Objective Response (Complete Response (CR) or Partial Response (PR))|Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population|||participants|||Number
2837289|NCT00226811|Secondary|Overall Survival|Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.|From start of study treatment until death|ITT population|||weeks||95% Confidence Interval|Median
2837290|NCT00226811|Secondary|Time to Tumor Progression (TTP)|Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population|||weeks||95% Confidence Interval|Median
2837291|NCT00226811|Secondary|Progression-Free Survival|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT population|||weeks||95% Confidence Interval|Median
2851998|NCT00036738|Secondary|Overall Survival|Number of patients surviving up to five years post-transplant.|Assessed up to 5 years||||Participants|||Count of Participants
2837292|NCT00226811|Secondary|Duration of Response (CR or PR)|Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer|ITT population|||weeks||Full Range|Mean
2837293|NCT00226811|Secondary|Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study|ITT population|||participants|||Number
2837294|NCT00226811|Primary|Best Overall Response|Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.|||participants|||Number
2837295|NCT00226655|Primary|Long Term Safety and Tolerability of hCRF|Number of patients reporting adverse events|Prospective|Intent to Treat|||Participants|||Number
2837296|NCT00226590|Secondary|Treatment Completion|The number of participants who completed all treatment on schedule without dose reductions or delays.|Ranging from 2 weeks up to 4 years, 9 months|per protocol|||participants|||Number
2837297|NCT00226590|Secondary|Overall Survival|To determine median Overall Survival rate|Ranging from 2 weeks up to 4 years, 9 months||||months||95% Confidence Interval|Median
2837298|NCT00226590|Secondary|Progression Free Survival|To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|per protocol|||months||95% Confidence Interval|Median
2837299|NCT00226590|Primary|Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation|Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|Per Protocol|||participants|||Number
2837300|NCT00226577|Secondary|Toxicity|Number of participants with toxicity ≥ Grade 3 after gemcitabine plus pemetrexed induction chemotherapy.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A total of 52 eligible patients, 26 men and 26 women, between the ages of 41 and 83 years received at least one dose of chemotherapy. Only 49 patients were evaluable because 3 patients had only the first cycle.|||participants|||Number
2837301|NCT00226577|Secondary|Survival - Overall|Median range of number of participants with Overall Survival. Overall survival (OS) will be defined as the period of time from the first day of drug treatment to the date of death of the patient. Patients taken off study will be followed quarterly until death for survival data.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|All patients|||months||Full Range|Median
2837302|NCT00226577|Secondary|Survival - Disease Free|Disease-free survival (DFS) is defined as the period of time from surgery to the time when disease recurrence is clearly documented. A histologic confirmation is required in equivalent cases.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|40 patients with complete tumor resection.|||months||Full Range|Median
2837303|NCT00226577|Secondary|Disease Response - Pathologic|Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen, which consists of equal to or more than 95% fibrosis and necrosis.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A pathologic response evaluation was possible in 43 of 52 patients.|||participants|||Number
2837304|NCT00226577|Primary|Disease Response - Radiographic|"Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan.~Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of >30% in the sum of the largest diameters of all measurable lesions and absence of new lesions."|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A radiographic response evaluation was possible in 49 of 52 patients.|||participants|||Number
2837305|NCT00226499|Secondary|Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness|Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).|During Phase B|The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.|||Hours||Standard Deviation|Mean
2837354|NCT00225784|Secondary|Number of Participants Assessed for Adverse Events|Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0|Participants were followed during treatment and for 30 days after completion of treatment|All participants were evaluated for toxicity.|||participants|||Number
2837306|NCT00226499|Secondary|Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.|From the beginning of Phase B (Year 2) up to study end (Year 10)|The analysis was performed on the Total enrolled cohort in Phase B, which included all subjects from the Total Vaccinated cohort in Phase A who returned for at least one visit in Phase B|||Participants|||Count of Participants
2837307|NCT00226499|Secondary|Phase B: Characteristics of Zoster Cases|Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.|From 6 weeks after Dose 2 until study end (Year 10)|The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2 and from the period when Phase A was completed.|||Participants|||Count of Participants
2837308|NCT00226499|Secondary|Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value|The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).|||Participants|||Count of Participants
2837309|NCT00226499|Secondary|Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations|Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).|||IU/mL||95% Confidence Interval|Geometric Mean
2837310|NCT00226499|Secondary|Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value|The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).|||Participants|||Count of Participants
2837311|NCT00226499|Secondary|Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations|Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).|||U/mL||95% Confidence Interval|Geometric Mean
2837312|NCT00226499|Secondary|Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value|The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).|||Participants|||Count of Participants
2837313|NCT00226499|Secondary|Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations|Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).|||mIU/mL||95% Confidence Interval|Geometric Mean
2837314|NCT00226499|Secondary|Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value|The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort (Adapted ATP cohort for each specific time point).|||Participants|||Count of Participants
2837315|NCT00226499|Secondary|Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations|Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).|At Year 4, Year 6, Year 8 and Year 10 time points|The analysis was performed on the Adapted persistence cohort (Adapted ATP cohort for each specific time point).|||mIU/mL||95% Confidence Interval|Geometric Mean
2837316|NCT00226499|Secondary|Phase B: Characteristics of Varicella Cases|Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.|From the beginning of Phase B (Year 2) up to study end (Year 10)|The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.|||Participants|||Count of Participants
2837317|NCT00226499|Secondary|Phase B: Number of Subjects With Probable or Confirmed Varicella Case|Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (‑)] AND was not epidemiologically linked [Epi (‑)] to another probable or confirmed case.|From the beginning of Phase B (Year 2) up to study end (Year 10)|The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.|||Participants|||Count of Participants
2837318|NCT00226499|Secondary|Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case|Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).|From the beginning of Phase B (Year 2) up to study end (Year 10)|The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.|||Participants|||Count of Participants
2837386|NCT00224874|Secondary|Cumulative Incidence of Systemic Infections||Measured at Day 270||||percentage of participants||95% Confidence Interval|Number
2837319|NCT00226499|Secondary|Phase B: Number of Subjects With Confirmed Varicella Case|Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.|From the beginning of Phase B (Year 2) up to study end (Year 10)|The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.|||Participants|||Count of Participants
2837320|NCT00226499|Secondary|Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness|Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).|During Phase A (from Day 0 up to Year 2)|The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.|||Hours||Standard Deviation|Mean
2837321|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.|From Day 0 until the end of Phase A (Year 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2837322|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE assessed included any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Within 43 days (Day 0-42) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837323|NCT00226499|Secondary|Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions|Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.|Within 43 days (Day 0-42) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837324|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Rash|Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = > 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.|Within 43 days (Day 0-42) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837325|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Parotitis|Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.|Within 43 days (Day 0-42) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837326|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Meningism|Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.|Within 43 days (Day 0-42) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837327|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (>) 20 mm.|4 days post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837328|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Fever|All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.|Within 15 days (Day 0-14) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837387|NCT00224874|Secondary|Number of Patients Surviving at 6 and 9 Months Post Randomization||Measured at 6 and 9 months|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
2837329|NCT00226499|Secondary|Phase A: Number of Subjects Reporting Fever|All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.|Within 43 days (Day 0-42) post-vaccination period following each dose|The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.|||Participants|||Count of Participants
2837330|NCT00226499|Secondary|Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster|The number of subjects with confirmed cases of herpes zoster is reported.|From Day 0 until the end of Phase A (Year 2)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2837331|NCT00226499|Secondary|Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects|Seronegative (S-) = Subjects with antibody concentration < 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||Participants|||Count of Participants
2837332|NCT00226499|Secondary|Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects|Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||IU/mL||95% Confidence Interval|Geometric Mean
2837333|NCT00226499|Secondary|Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects|Seronegative (S-) = Subjects with antibody concentration < 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||Participants|||Count of Participants
2837334|NCT00226499|Secondary|Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects|Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||U/mL||95% Confidence Interval|Geometric Mean
2837335|NCT00226499|Secondary|Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects|Seronegative (S-) = Subjects with antibody concentration < 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||Participants|||Count of Participants
2837336|NCT00226499|Secondary|Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects|Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||mIU/mL||95% Confidence Interval|Geometric Mean
2837337|NCT00226499|Secondary|Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV|Seronegative (S-) = Subjects with antibody concentration less than (<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||Participants|||Count of Participants
2837338|NCT00226499|Secondary|Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations|Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).|At Day 0, Day 42, Day 84, Year 1 and Year 2 time points|The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.|||mIU/mL||95% Confidence Interval|Geometric Mean
2837339|NCT00226499|Secondary|Phase A: Number of Subjects With Probable or Confirmed Varicella Case|Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (‑)] AND was not epidemiologically linked [Epi (‑)] to another probable or confirmed case.|From 42 days post dose 2 until the end of Phase A|The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.|||Participants|||Count of Participants
2837388|NCT00224874|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD)|Number of patients with limited and extensive chronic GVHD at 9 months|Measured at 9 months|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
2851999|NCT00036738|Secondary|Leukemia-free Survival|Number of patients surviving in CR up to five years post-transplant.|Assessed up to 5 years||||Participants|||Count of Participants
2837340|NCT00226499|Secondary|Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case|Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).|From 42 days post dose 2 until the end of Phase A|The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.|||Participants|||Count of Participants
2837341|NCT00226499|Primary|Phase A: Number of Subjects With Confirmed Varicella Case|Confirmed varicella case = A case that met the clinical case definition [an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause] at least in the opinion of the investigator and was confirmed by laboratory test [Polymerase Chain Reaction (PCR) (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.|From 42 days post dose 2 until the end of Phase A|The analysis was performed on the According-to-Protocol (ATP) Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.|||Participants|||Count of Participants
2837342|NCT00226239|Other Pre-specified|EGFR-related Serum Markers|Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.|Up to 36 months|||||||
2837343|NCT00226239|Secondary|Quality of Life (QOL)|"Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy-General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days. The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state."|Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE|Analysis was completed using all responses actually obtained.|||units on a scale||Standard Deviation|Mean
2837344|NCT00226239|Secondary|3-year Overall Survival (OS)|Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.|Up to 36 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.|||percentage of participants||95% Confidence Interval|Number
2837345|NCT00226239|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|Up to 24 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.|||percentage of participants||95% Confidence Interval|Number
2837346|NCT00226239|Secondary|Progression-free Survival (PFS)|PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.|Up to 36 months|All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.|||percentage of participants||95% Confidence Interval|Number
2837347|NCT00226239|Secondary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.|Up to 36 months|Docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE).|||percentage of participants||95% Confidence Interval|Number
2837348|NCT00226239|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.|Up to 36 months|Treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles.|||percentage of participants||95% Confidence Interval|Number
2837349|NCT00225784|Secondary|Pattern of Failure After Therapy|Local recurrence, distant recurrence, or both.|Five years post treatment|All participants who completed treatment and underwent resection|||participants|||Number
2837350|NCT00225784|Secondary|Overall Length of Survival After Therapy|Length of survival after therapy in all participants enrolled.|Five years post treatment|All participants enrolled regardless of evaluability for primary outcome measure.|||months||Full Range|Median
2837351|NCT00225784|Secondary|Disease-Free Survival After Therapy|Time to disease progression after therapy.|Five years post treatment|All evaluable participants who completed treatment, and had confirmed progression of disease.|||months||Full Range|Median
2837352|NCT00225784|Secondary|Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.|Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.|One month post-therapy|All EGFR (-) subjects who completed therapy were evaluated.|||percent|||Number
2837353|NCT00225784|Secondary|Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy|Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).|1 month after completion of treatment|Surviving participants who completed therapy and were determined to be resectable.|||participants|||Number
2837355|NCT00225784|Primary|Objective Response of Tumor by RECIST 1.0 Criteria|Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.|one month post-therapy|Completion of treatment|||participants|||Number
2837356|NCT00225758|Secondary|Determine Whether Changes in Plasma DNA Concentrations Are Predictive Markers of an Early Response to Lapatinib||14 weeks|Plasma DNA assays were not done due to difficulty obtaining plasma specimens from the outside sites, and technical problems with the assay in the specimens collected at our institution..||||||
2837357|NCT00225758|Secondary|Determine Changes in Activation of Tumor Cell ERK and Akt, as Between the Hormonal Agent and Lapatinib Contributes to the Molecular Pharmacodynamic Effect Postulated Above.||4 weeks|None of the patients had the recommended biopsies done as the biopsies were optional, and over half the patients had either bone-only disease or only non-biopsiable soft tissue disease.||||||
2837358|NCT00225758|Secondary|Determine the Toxicities of the Combination of the Hormonal Agent and Lapatinib in Patients With Metastatic Breast Cancer||26 weeks|All 27 subjects are evaluable for toxicity|||Participants|||Count of Participants
2837359|NCT00225758|Primary|Progression-free Survival|Progression-free survival is the time between date on study and progression based on RECIST criteria.|Up to 575 days||||days||Inter-Quartile Range|Median
2837360|NCT00225758|Primary|Determine the Response Rate and Progression Free Survival of Hormone Therapy-resistant Patients With Metastatic Breast Cancer Treated With the Same Continued Hormonal Agent With the Addition of Lapatinib.|A response is defined as stable disease or better at 26 weeks. Twenty two patients are evaluable for response|26 weeks|Of the 27 enrolled subjects, five subjects came off study due to toxicity prior to week 14, at the time of the first restaging. The remaining 22 subjects are evaluable for response.|||Participants|||Count of Participants
2837361|NCT00225732|Primary|Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery|Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery|24 Hours||||milligrams||Standard Error|Least Squares Mean
2837362|NCT00225498|Primary|Working Memory|"California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome.~The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner."|3 months|The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.|||units on a scale||Standard Deviation|Mean
2837363|NCT00225420|Secondary|Biochemical Progression-free Survival (PFS)|Measure of the activity of a treatment on a disease. In this study it is measured from the date of enrollment to the date on which the prostate cancer progresses or the date the patient dies. Survival curves were estimated using the Kaplan-Meier technique. Biochemical (PSA) failure is defined, in accordance to the American Society for Therapeutic Radiology and Oncology consensus definition, as three consecutive rise in PSA. The date of biochemical failure is considered to be the midpoint between the last non-rising PSA and the first rising PSA.|Average follow up of 2 years||||percentage of patients||95% Confidence Interval|Mean
2837364|NCT00225420|Primary|Number of Patients Experiencing Dose-Limiting Toxicities|Determine the number of patients experiencing dose-limiting toxicities (DLT) at each dose level. DLT was defined as grade 3-4 non-haematological or grade 4 haematological toxicity, using the Common Terminology Criteria for Adverse Events, version 3.0.|Average follow up of 2 years||||Participants|||Count of Participants
2837365|NCT00225277|Other Pre-specified|Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee|The incidence of cardiovascular events and composite endpoints occurring within 30 days of last dose as adjudicated by the Clinical Endpoint Committee. Abbreviations: PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure.|Up to 72 weeks|Safety Population|||Number of Events|||Number
2837366|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint C cardiovascular events is being reported instead of time to first occurrence. Endpoint C conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.|||participants|||Number
2837367|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint B cardiovascular events is being reported instead of time to first occurrence. Endpoint B conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.|||Participants|||Number
2837368|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint A cardiovascular events is being reported instead of time to first occurrence. Endpoint A conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.|||Participants|||Number
2837443|NCT00224003|Primary|Transferrin Saturation|Change from baseline to 2 weeks after last dose|14 weeks|Per protocol (completer) population|||%||Standard Deviation|Mean
2837369|NCT00225277|Secondary|Nominal Change From Baseline in Normalized Total Atheroma Volume|The nominal change in normalized total atheroma volume as measured by the average of plaque areas for all slices of anatomically comparable segments of the target coronary artery multiplied by the mean number of matched slices in the population. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.|||Percent volume||Standard Error|Least Squares Mean
2837370|NCT00225277|Primary|Nominal Change From Baseline in Percent Atheroma Volume|The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.|||Percent volume||Standard Error|Least Squares Mean
2837371|NCT00225251|Secondary|Global Assessment of Functioning Scale (GAFS)|A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)|10 weeks||||units on a scale||Standard Deviation|Mean
2837372|NCT00225251|Secondary|Clinical Global Improvement (CGI)|A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)|10 weeks||||units on a scale||Standard Deviation|Mean
2837373|NCT00225251|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|10 weeks||||units on a scale||Standard Deviation|Mean
2837374|NCT00225251|Secondary|Cornell Dysthymia Rating Scale (CDRS)|A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression|10 weeks||||units on a scale||Standard Deviation|Mean
2837375|NCT00225251|Primary|Hamilton Depression Rating Scale, 24 Items (HDRS)|"Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.~This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)"|10 weeks||||units on a scale||Standard Deviation|Mean
2837376|NCT00225212|Secondary|Overall Survival (OS)||24 months||||percentage of subjects remaining alive||95% Confidence Interval|Number
2837377|NCT00225212|Primary|Event-free Survival (EFS)|"Events for EFS were defined as the earlier of post-ASCT relapse or death."|24 months||||percentage of not experiencing EFS event||95% Confidence Interval|Number
2837378|NCT00225147|Secondary|Time to Minimal Symptoms|"The time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment timepoints were: baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to minimal symtoms has been calculated by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."|||minutes||Full Range|Median
2837379|NCT00225147|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms at the location that showed the first visual analogue scale (VAS) score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."|||minutes||Full Range|Median
2837380|NCT00225017|Secondary|Changes in LDL Particle Number From Baseline to Week 24|Change in LDL particle number|Baseline to 24 weeks||||nmol/l||Inter-Quartile Range|Median
2837381|NCT00225017|Secondary|Change in Total Cholesterol Levels From Baseline to Week 24|Total cholesterol level changes within and between arms|Baseline to 24 weeks||||mg/dL||Inter-Quartile Range|Median
2837382|NCT00225017|Primary|Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24|Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen|Baseline to week 24||||percentage change||Inter-Quartile Range|Median
2837383|NCT00224952|Secondary|Age-related Changes in Bioactivation|2. To determine if age-related differences exist regarding the ability of pediatric patients to bioactivate carbamazepine or valproate to reactive metabolites. Data provided below reflect the slope of the least squares regression.|urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years|Change in Carbamazepine detoxification as a function of age is determined only in patients in the Carbamazepine Phase 2 arm. Changes in Valproic Acid detoxification as a function of age are determined only in patients in the Valproic Acid Phase 2 arm.|||years^(-1)|||Number
2837384|NCT00224952|Primary|Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine|1. To examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine the identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species (e.g., through conjugation with detoxifying compounds such as glutathione).|urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years|Carbamazepine detoxification product (MTHIS) was only measured in the Carbamazepine Phase I and 2 arms. Valproic Acid (NAC) detoxification products were only measured in the Valproic Acid Phase 2 arm. Units of measure for all analytes are nmol per mg creatinine.|||nmol per mg creatinine||Standard Deviation|Mean
2837385|NCT00224874|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||Measured at 9 months|No data collected||||||
2837389|NCT00224874|Secondary|Number of Patients Discontinuing Immune Suppression Without Flare|Immunosuppression discontinuation was defined as the discontinuation of corticosteroids and all additional immunosuppressives, except cyclosporine or tacrolimus, for treatment of acute GVHD without subsequent flare by Day 90 post-initiation of therapy and later by discontinuation of all immunosuppressive medications, including cyclosporine or tacrolimus.|Measured at Days 90, 180, and 270 post-treatment|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
2837390|NCT00224874|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90|Flares were defined as any increase in symptoms of or therapy for acute GVHD after an initial response (i.e., progression from an earlier CR or PR).|Measured at Day 90|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
2837391|NCT00224874|Secondary|Proportion of Treatment Failure||Measured at Day 56||||percentage of participants||95% Confidence Interval|Number
2837392|NCT00224874|Secondary|Number of Partial Response (PR), Mixed Response (MR), and Progression|Partial response, mixed response, and progression at Day 28 after randomization. Partial response was defined as improvement in one or more organs involved with Graft-Versus-Host Disease (GVHD) symptoms without progression in others. Mixed response was defined as improvement in one or more organs with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ. Progression was defined as deterioration in at least one organ without any improvement in others.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
2837393|NCT00224874|Primary|Number of Complete Response (CR) at Day 28 of Therapy|Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis|||participants|||Number
2837394|NCT00224770|Primary|Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180|Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead|180 days from randomization||||percentage of participants||90% Confidence Interval|Number
2837395|NCT00224770|Secondary|Post-operative Clot Size Reduction|The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.|Time from post-operation until end of treatment, up to 10 days|Analysis population only includes surgical patients.|||percentage of blood clot resolved||Inter-Quartile Range|Median
2837396|NCT00224770|Secondary|Clot Size Reduction by End of Treatment|The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.|Time from randomization until end of treatment, up to 10 days||||percentage of blood clot resolved||Inter-Quartile Range|Median
2837397|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 365|Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|365 days from randomization||||units on a scale||Inter-Quartile Range|Median
2837398|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 180|Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|180 days from randomization||||units on a scale||Inter-Quartile Range|Median
2837399|NCT00224770|Primary|Safety Outcome Number 4: Rate of Symptomatic Rebleeding|The difference in the rate of symptomatic rebleeding 72 hours post last dose.|72 hours post last dose||||percentage of participants||90% Confidence Interval|Number
2837400|NCT00224770|Primary|Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis|Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.|30 days from randomization||||percentage of participants||90% Confidence Interval|Number
2837401|NCT00224770|Primary|Safety Outcome Number 2: Rate of Procedure-related Mortality|Percentage of participants who died during the first 7 days after randomization.|7 days from randomization||||percentage of participants||90% Confidence Interval|Number
2837402|NCT00224770|Primary|Safety Outcome Number 1: Rate of Mortality|Percentage of participants who died during the first 30 days after randomization.|30 days from randomization||||percentage of participants||90% Confidence Interval|Number
2837444|NCT00224003|Secondary|Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.||14 weeks|||||||
2837445|NCT00224003|Primary|Serum Ferritin|Change from baseline to 2 weeks after last Fe dose|14 weeks|Per protocol (completer) population|||ng/mL||Standard Deviation|Mean
2837403|NCT00224484|Secondary|Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). The subset of subjects used for this analysis was 50% of the pre-defined subset of subjects that underwent assessment of biochemical and hematological parameters.|At months 0, 7 and 12|The analyses were performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects included in the immunogenicity subset for whom data concerning immunogenicity outcome measures were available (for whom assay results were available for antibodies against the study vaccine antigen component after Vaccination).|||EU/mL||95% Confidence Interval|Geometric Mean
2837404|NCT00224484|Secondary|Anti-glycoprotein D (Anti-gD) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). Analysis was based on an immunogenicity subset, stratified by initial serostatus: HSV seronegative (-)/ seropositive (+), this included gD2-AS04 vaccine recipients, as follows: HSV 1 and HSV 2 seronegative (HSV1-/2-) and HSV 1 seropositive and HSV 2 seronegative (HSV1+/2-)|At months 0, 7 and 12|"The analysis was performed on the ATP cohort for immunogenicity, in a predefined immunogenicity subset of HSV vaccine recipients (gD2-AS04 Group) who underwent assessment of biochemical and hematological parameters. Data from participants in the Havrix Group and Saline Group were not collected."|||EU/mL||95% Confidence Interval|Geometric Mean
2837405|NCT00224484|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.|Up to month 18 (during active phase and ESFU period)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. For the purpose of this analysis, the subjects from Havrix Group and Saline group were pooled into one group: Pooled Group.|||Participants|||Count of Participants
2837406|NCT00224484|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.|During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. For the purpose of this analysis, the subjects from Havrix Group and Saline group were pooled into one group: Pooled Group.|||Participants|||Count of Participants
2837407|NCT00224484|Secondary|Number of Subjects With Medically Significant Conditions (MSC)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.|During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. For the purpose of this analysis, the subjects from Havrix Group and Saline group were pooled into one group: Pooled Group.|||Participants|||Count of Participants
2837408|NCT00224484|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.|Starting from Day 30 until the end of study (Month 18)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837409|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents WBC results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837410|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents UREA results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837446|NCT00223977|Secondary|Responders by Treatment Group|Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.|Baseline to 5 weeks and 9 weeks||||participants|||Number
2837447|NCT00223977|Secondary|Change From Baseline in Serum Ferritin.|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks||||ng/mL||Standard Deviation|Mean
2837411|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents RBC results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837412|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents PLA results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837413|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents Hct results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837414|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents CREA results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837415|NCT00224484|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed|Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents ALT results.|At months 7 and 12|The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837416|NCT00224484|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|During the active phase (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837417|NCT00224484|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.|Within the 30 Day (Day 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837418|NCT00224484|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.|Within 30 days (Day 0-29) after any vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837448|NCT00223977|Secondary|Change From Baseline in Transferrin Saturation (TSAT).|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks||||percent||Standard Deviation|Mean
2837419|NCT00224484|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.|Within 7 days (Days 0-6) after each and any vaccination|The analyses were performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed, who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837420|NCT00224484|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (>) 30mm diameter and persisting more than 24 hours.|Within 7 days (Days 0-6) after each and any vaccination|The analyses were performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed, who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837421|NCT00224484|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 12|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2837422|NCT00224289|Primary|Post-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|8 Weeks||||mm Hg||Standard Deviation|Mean
2837423|NCT00224289|Primary|Pre-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|At baseline (before treatment)||||mm Hg||Standard Deviation|Mean
2837424|NCT00224133|Secondary|International Prostate Symptom Score (IPSS)|The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.|9 months||2010-03-31|03/2010||||
2837425|NCT00224133|Primary|Adverse Events|All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.|9 months|Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.|||participants|||Number
2837426|NCT00224120|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks||Baseline and 12 weeks||||mL/min||Standard Deviation|Mean
2837427|NCT00224120|Primary|Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms|Baseline and 12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
2837428|NCT00224107|Secondary|Maximum Urine Flow Rate (Qmax)|Change from baseline in maximum urine flow rate (Qmax)at Week 12|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||mL/sec||Standard Deviation|Mean
2837429|NCT00224107|Primary|International Prostate Symptom Score (IPSS)|Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a 0 to 35 scale||Standard Deviation|Mean
2837430|NCT00224055|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||ng/mL||Standard Deviation|Mean
2837431|NCT00224055|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||g/dL||Standard Deviation|Mean
2837432|NCT00224042|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||ng/mL||Standard Deviation|Mean
2837433|NCT00224042|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation|||g/dL||Standard Deviation|Mean
2837434|NCT00224042|Secondary|Baseline Serum Ferritin Concentration||Baseline||||ng/mL||Standard Deviation|Mean
2837435|NCT00224042|Primary|Baseline Hemoglobin Concentration||Baseline||||g/dL||Standard Deviation|Mean
2837436|NCT00224029|Secondary|Urinary Leakage and Catheterization Data||8 weeks|||||||
2837437|NCT00224029|Secondary|Urodynamic Measurements||8 weeks|||||||
2837438|NCT00224029|Secondary|Patch Adhesion||8 weeks|||||||
2837439|NCT00224029|Primary|Average Number of Catheterizations Without Leaking Per Day|Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.|8 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF.|||Number of Dry Catheterizations per Day||Standard Deviation|Mean
2837440|NCT00224016|Secondary|Urine Volume After First Awakening|Change from baseline in average volume of urine collected after first morning awakening|14 weeks|||||||
2837441|NCT00224016|Secondary|Catheterizations Without Leakage|Percentage of catherizations without leakage|14 weeks|mITT, LOCF|||% of participants||Standard Deviation|Mean
2837442|NCT00224016|Primary|Average Catheterization Urine Volume|Change from baseline in average volume of urine collected by catheterization|14 weeks|Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation|||mL||Standard Deviation|Mean
2837449|NCT00223977|Secondary|Change From Baseline in Hematocrit (Hct)|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks||||percent||Standard Deviation|Mean
2837450|NCT00223977|Primary|Hemoglobin|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|modified intent to treat (mITT) with last observation carried forward (LOCF) imputation|||ng/mL||Standard Deviation|Mean
2837451|NCT00223821|Secondary|Change in Incontinent Episodes at 12-month Follow-up|Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries|Baseline and 12 months post-treatment|Intention to treat|||percent change||Standard Deviation|Mean
2837452|NCT00223821|Primary|Change in Incontinent Episodes Immediately Post-treatment|Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.|Baseline and immediately post-treatment - week 8|Intention to treat|||percentage change||Standard Deviation|Mean
2837453|NCT00223808|Secondary|Change in FIM Score at 6-months|"Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63~."|Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.|||units on a scale||Standard Error|Mean
2837454|NCT00223808|Secondary|Change in FIM Score Immediately Following Study Intervention.|Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.|After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.||||units on a scale||Standard Error|Mean
2837455|NCT00223808|Primary|Fugl-Meyer Score Change at 6 Months|Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.|FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.|||units on a scale||Standard Error|Mean
2837456|NCT00223808|Primary|Fugl-Meyer Score Change Immediately Following Study Intervention.|Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.|After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.||||units on a scale||Standard Error|Mean
2837457|NCT00223795|Primary|Peak Vertical Force on Affected Limb|An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).|Baseline and end of first intervention period (2 months)||||N/kg||Standard Deviation|Mean
2837458|NCT00223704|Secondary|Fibrinolytic Response as Measured by D-dimer|D-dimer concentrations were measured at baseline, 30min and 60min of bypass, post-bypass and postoperative day 1|Patients were followed from the start of surgery until postoperative day 1||||ng/ml||Standard Error|Mean
2837459|NCT00223704|Secondary|Inflammatory Response as Measured by Interleukin-6|Interleukin-6 was measured at baseline, post-bypass and on postoperative day 1 and 2.|Patients were followed from the start of surgery until postoperative day 2||||pg/ml||Standard Error|Mean
2837460|NCT00223704|Secondary|Units of Plasma Transfused During Hospitalization|Units of plasma transfused|Patients were followed for the duration of hospital stay, an average of 6 days||||units||Standard Error|Mean
2837461|NCT00223704|Secondary|Units of Packed Red Blood Cells Transfused During Hospitalization|Units of Packed Red Blood Cells Transfused|Patients were followed for the duration of hospital stay, an average of 6 days||||units||Standard Error|Mean
2837462|NCT00223704|Primary|Allogenic Blood Product Transfusion Risk|Blood product transfusion during hospitalization that included packed red blood cells, plasma, platelets and cryoprecipitate.|Patients were followed for the duration of hospital stay, an average of 6 days||||percentage of participants|||Number
2837463|NCT00223678|Primary|Graft Survival||3 years||||participants||95% Confidence Interval|Median
2837464|NCT00223665|Secondary|Score on Verbal Ability/Fluency Testing During First Cycle of IAS|Verbal Ability/Fluency was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. Participants were asked to verbally generate as many words beginning with a particular letter (e.g. P) within a 60 second period. Two trials were administered with two different letters. The total number of words generated was recorded for each letter and summed and analyzed.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of words generated||Standard Deviation|Mean
2837465|NCT00223665|Secondary|Score on Spatial Memory Testing During First Cycle of IAS|Spatial Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT using the Puget Sound Route Learning Test. This test measured the ability to navigate a short route within a room. Three trials were administered followed by three trials of a new route using pictures placed on the floor as landmarks. A delayed recall is administered after twenty minutes. Performance was assessed based on number of correctly recalled sequences after a delay.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||number of correctly recalled sequences||Standard Deviation|Mean
2837466|NCT00223665|Secondary|Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS|Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via Story Recall. This task is based on the well known Wechsler Memory Scale -Revised Logical Memory task. Participants listened to two brief narratives (stories) and were asked to recall as much as possible immediately after hearing each story and following a 20-minute delay. Assessment was based on number of correctly recalled pieces of information after a delay.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||number of correctly recalled data points||Standard Deviation|Mean
2837467|NCT00223665|Secondary|Score on Visual Working Memory Test During First Cycle of IAS|Visual Working Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This task is based on the Subject Ordered Pointing Task (SOPT). The participant is shown a grid array of 10, 12 or 16 abstract designs and they must choose a new design with each refresh of the screen. Assessment is based on total number of errors.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||total number of errors||Standard Deviation|Mean
2837468|NCT00223665|Secondary|Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS|Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via the Proactive Interference (PI) task. The PI task involves participants listening to a list of 10 words from the same semantic category (e.g., articles of clothing), and then recalling as many of these words as possible.The procedure is repeated for a total of 4 trials. Assessment is based on the total number of words recalled.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of correctly recalled words||Standard Deviation|Mean
2837469|NCT00223665|Secondary|Score on Executive Function Testing (Stroop Task) During First Cycle of IAS|Executive Function was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Stroop Color Word Interference Task. Subjects are asked to read 100 color words (red, green, blue), followed by identification of color blocks followed by reading the color of the ink and ignoring the word (e.g., the word 'blue' printed in green letters). Assessment was based on the amount of time needed to time to complete the assessment.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||minutes to complete the assessment||Standard Deviation|Mean
2837470|NCT00223665|Secondary|Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS|Spatial Ability (Mental Rotation) was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Vandenberg & Kuse (1978) Mental Rotation Test. Subjects are presented with line drawings of complex, three dimensional cubes on a computer screen. The subject must compare the two drawings and decide if they match. Score is based on number of correctly identified figures.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of correctly identified figures||Standard Deviation|Mean
2837471|NCT00223665|Secondary|Score on Spatial Ability Test (Block Design) During First Cycle of IAS|Spatial Ability was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Wechsler Adult Intelligence Scale-Revised, Block Design sub-test and measures participants' ability to analyze and construct abstract figures from their component parts. The test allows a time limit of 3 minutes per design, for a total of nine designs. Score is based on total number of designs completed (max 9, min 0).|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having these neuro-psychological assessments at each of the listed time points.|||Number of correctly completed designs||Standard Deviation|Mean
2837472|NCT00223665|Secondary|Estradiol Levels During First Cycle of IAS|Estradiol was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having estradiol measurements at each of the listed time points.|||pg/ml||Standard Deviation|Mean
2837473|NCT00223665|Secondary|Testosterone Levels During IAS|Testosterone was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.|Baseline, Month 3, Month 9, and Month 12|Sub-population of 20 evaluable patients, defined as having completed first cycle of ADT (9 months), having at least a 3 month treatment break afterwards, and having testosterone measurements at each of the listed time points.|||ng/ml||Standard Deviation|Mean
2837559|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.|||hr||Standard Deviation|Mean
2837474|NCT00223665|Secondary|Development of Osteopenia (Bone Loss) During IAS|Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm^2 as a indicator of bone health for each patient at each time point. This measure was defined as the percentage of participants with normal BMD scores at baseline who developed Osteopenia after the first cycle of ADT.|From screening prior to first dose of ADT through the start of the second cycle of ADT.|38 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2; having baseline DEXA BMD within normal range at both spine and left hip.|||percent of participants|||Number
2837475|NCT00223665|Secondary|Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS|Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm^2 as a indicator of bone health. Percent change was assess for each patient at each time point.|From screening prior to first dose of ADT through the start of the second cycle of ADT.|Out of 102 enrolled subjects, 56 were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), no prior or concurrent use of bisphosphonates, and a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2.|||Percent change of BMD|||Number
2837476|NCT00223665|Secondary|Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS|Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm^2 as a indicator of bone health for each patient at each time point.|From screening prior to first dose of ADT through the start of the second cycle of ADT.|56 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2.|||Percent change in BMD|||Number
2837477|NCT00223665|Primary|Effect of IAS on Overall Survival.|Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause.|From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years.|62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient data to assess survival status.|||years||Full Range|Median
2837478|NCT00223665|Primary|Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)|Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels <50 ng/dL.|From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years.|62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient PSA measurements to assess androgen independence.|||years||Full Range|Median
2837479|NCT00223652|Secondary|Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up|"Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE).~A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up."|6-month follow up at week 44 post treatment||||participants|||Number
2837480|NCT00223652|Secondary|Maintenance of Treatment Effect|"6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9).~Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9.~PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively."|6-month post treatment follow-up||||units on a scale||Standard Deviation|Mean
2837481|NCT00223652|Primary|Number of Participants Meeting Criteria for Major Depressive Disorder|Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.|Baseline to week 12, and week 20||||participants|||Number
2837482|NCT00223652|Primary|Change in Severity of Depression Using the Patient Health Questionnaire-9|"Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9).~Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.~PHQ-9 score ranges from 0-27, higher values indicate more severe depression."|Baseline, Week 12, Week 20||||units on a scale||Standard Deviation|Mean
2837483|NCT00223652|Secondary|Maintenance of Treatment Effect|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.~Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|6 month follow-up (week 44)||||units on a scale||Standard Deviation|Mean
2837484|NCT00223652|Primary|Change in Severity of Depression Using Hamilton Depression Rating Scale|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D).~Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D).~Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.~Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|Baseline, 12 weeks, 20 weeks||||units on a scale||Standard Deviation|Mean
2837485|NCT00223496|Primary|Primary Measure:Reduction in Depression Symptoms|Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).|up to 12 weeks||||participants|||Number
2837486|NCT00223262|Primary|Rey Auditory Verbal Learning Test (RAVLT)|Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.|24 weeks||||T-scores||Standard Deviation|Mean
2837487|NCT00223236|Secondary|Rey Auditory Verbal Learning Test(RAVLT)|The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).|Change in T scores between baseline and exit (exitT score - baseline T score).|number of participants are calculated based on those who completed baseline and at least one treatment visit.|||T score||Standard Deviation|Mean
2837488|NCT00223236|Secondary|Young Mania Rating Scale(YMRS).|The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Baseline to exit (exit score - baseline score)|Numbers of participants are those who completed baseline assessment and at least one treatment visit.|||units on a scale||Standard Deviation|Mean
2837489|NCT00223236|Secondary|Inventory of Depressive Symptomatology Self Report (IDS-SR).|The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Change in scores between baseline and exit (exit - baseline).|Number of participants reported are those who completed baseline assessment and at least one treatment visit.|||units on scale||Standard Deviation|Mean
2837490|NCT00223236|Primary|Cocaine Use Determined by Urine Analysis|Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.|Biweekly (visit) urine drug screens|Number of participants are those who completed baseline assessment and at least one treatment visit followed by baseline.|||percentage of participants no cocaine|||Number
2837491|NCT00223080|Secondary|Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)|"Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question Do you think that your everyday behavior puts you at risk for HIV infection? Modified intent to treat population (MITT)"|Week 182|Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded|||participants|||Number
2837492|NCT00223080|Secondary|Safety Assessment (SAE's and AEs)|The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized|Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u period|intent-to-treat population|||adverse events|||Number
2837493|NCT00223080|Primary|Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population|Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.|42 months|Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.|||log [HIV-1 viral load (unitless)]||Standard Error|Mean
2837494|NCT00223080|Primary|Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population|Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.|42 months|Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study|||log [HIV-1 viral load (unitless)]||Standard Error|Mean
2837495|NCT00223080|Secondary|Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population|Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.|42 weeks|Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded|||cells / µL||Standard Error|Mean
2837496|NCT00223080|Primary|Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population|Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.|42 Months|Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.|||Percentage of subjects||95% Confidence Interval|Number
2837497|NCT00223080|Primary|Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population|HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.|42 Months|Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study|||Percetage of subjects||95% Confidence Interval|Number
2837498|NCT00222729|Secondary|Overall Survival (OS)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg|||months||90% Confidence Interval|Median
2837499|NCT00222729|Secondary|Disease Control Rate (DCR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg|||percentage||90% Confidence Interval|Median
2837500|NCT00222729|Secondary|Objective Response Rate (ORR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2|||percentage||90% Confidence Interval|Median
2837501|NCT00222729|Primary|Time-to-progression (TTP)|TTP was calculated from treatment initiation to disease progression or last follow-up.|Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2|||months||90% Confidence Interval|Median
2837502|NCT00222131|Secondary|Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours|Time (minutes) gastric pH remained >4.0 during 24-hours gastric pH monitoring.|8 Weeks||||minutes||Standard Error|Mean
2837503|NCT00222131|Primary|Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms|"Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked Please state for each day if you have experienced pain or discomfort in the stomach. Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period."|8 Weeks||||percentage of participants|||Number
2837504|NCT00222105|Secondary|Toxicity|Count of Participants with adverse events.|End of study, up to 12 months||||Participants|||Count of Participants
2837505|NCT00222105|Primary|Overall Response Rate|Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.|At End of Cycle 1, 28 Days|Five subjects did not complete first cycle.|||percentage of participants|||Number
2837506|NCT00221299|Primary|Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.|In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.|BMD changes from year 1 to year 2|Per protocol|||percent change||Standard Deviation|Mean
2837507|NCT00221195|Primary|Number of Bleeds During 6 Month Treatment Period||6 months||||bleeds||Standard Deviation|Mean
2837508|NCT00221117|Secondary|Spinal Cord Independence Measure (SCIM).|Score range from 0-100. Higher score represent a better outcome.|30 min||||units on a scale||Standard Deviation|Mean
2837509|NCT00221117|Secondary|Rehabilitation Engineering Laboratory Hand Function Test(REL Test)|The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) evaluates gross motor function of unilateral grasp (also referred to as the Rehabilitation Engineering Laboratory Hand Function Test). Hand functions that are assessed with TRI-HFT include the following: lateral or pulp pinch and palmar grasp.Score range from 0-70. Higher values represent a better outcome.|45 min|The subject’s impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data.|||units on a scale||Standard Deviation|Mean
2838659|NCT00201240|Secondary|Acute Graft Versus Host Disease (GVHD)|Incidence and severity of acute GVHD will be graded according to the BMT CTN MOP.|Day 100||||percentage of participants||95% Confidence Interval|Number
2837510|NCT00221117|Primary|Functional Independence Measure (FIM)|Functional Independent Measure was employed to measure the degree of disability for daily self care. It capture data on self-care, sphincter management, transfers,locomotion,communication,and social cognition.The scale is divided according to no helper category (level 6 and 7) where no other person is required to help with the activity and a hel;per category(level 1 through 5)where the patient needs minimal to total assistance from another person to accomplish the activity Score range from 18-126. Higher values represent a better outcome.|35 min||||units on a scale||Standard Deviation|Mean
2837511|NCT00221104|Secondary|Incidence Rate of Intracranial Hemorrhage|Incidence rate of patients with intracranial hemorrhage|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
2837512|NCT00221104|Secondary|Incidence Rate of Cardioembolic Infarction|Incidence rate of patients with cardioembolic infarction|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
2837513|NCT00221104|Secondary|Incidence Rate of Lacunar Infarction|Incidence rate of patients with lacunar infarction|up to 5 years|intention to treat|||events /100 person years||95% Confidence Interval|Number
2837514|NCT00221104|Secondary|Incidence Rate of Atherothrombotic Infarction|Incidence rate of patients with atherothrombotic infarction|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
2837515|NCT00221104|Primary|Incidence Rate of Stroke and TIA|Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)|up to 5 years|intention to treat|||events /100 person-years||95% Confidence Interval|Number
2837516|NCT00220961|Secondary|Change in Atherosclerosis|carotid intima thickness|Baseline versus 2.4 years||||percentage of intima||Standard Deviation|Mean
2837517|NCT00220961|Secondary|Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)|Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.|Baseline versus 2.4 years||||matsuda index||Standard Deviation|Mean
2837518|NCT00220961|Secondary|Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test|Insulin secretion|Baseline versus 2.4 years||||nmol||Standard Deviation|Mean
2837519|NCT00220961|Secondary|Change From Baseline in Fasting Plasma Glucose of 2.4 Years|Fasting Plasma Glucose|Baseline versus 2.4 years||||mg/dl||Standard Deviation|Mean
2837520|NCT00220961|Primary|Prevention of Type 2 Diabetes|Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization|2.4 years||||percentage of participants|||Number
2837521|NCT00220805|Secondary|Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center||At end of treatment (12 weeks)|Intent to Treat|||Disk Diameter||Standard Deviation|Mean
2837522|NCT00220805|Secondary|Presence of Fibrosis and Location Assessed by Slit-lamp||Last measurement at or later than Week 8|Intent to Treat|||participants|||Number
2837523|NCT00220805|Secondary|Proportion of Subjects With an Increase ≥ 2 or More Points in Lens Opacity Classification System (LOCS III) for Nuclear Opalescence, Nuclear Color, Cortical Cataract or Posterior Subcapsular Cataract Categories|The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.|Last measurement at or later than Week 8|Intent to Treat subjects with cataract|||participants|||Number
2837524|NCT00220805|Secondary|Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)|The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.|Last measurement at or later than Week 8|Intent to Treat|||LogRAD||Standard Deviation|Mean
2837525|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR||Last measurement at or later than Week 8|Intent to Treat|||percentage of participants|||Number
2837526|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR||Last measurement at or later than Week 8|Intent to Treat|||percentage of participants|||Number
2837527|NCT00220805|Primary|Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)|Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.|At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period|The Intent-to-Treat (ITT) Population consisted of all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (LogMAR score) at Week 8 or later and at Baseline.|||LogMAR||Standard Deviation|Mean
2837528|NCT00220779|Primary|Percentage of Relapse Free Subjects (no Relapse)|A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.|12 months|Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population.|||percentage of participants|||Number
2837529|NCT00220779|Secondary|Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)||1 year|||||||
2837560|NCT00219557|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)|Tmax was based on the actual time points when the samples were collected.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.|||hr||Full Range|Median
2837530|NCT00220740|Secondary|Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period||6 months|In the Randomized Withdrawal Period, 43 subjects were randomized to IGIV-C, but only 31 out of the 41 subjects were prior IGIV-C responders or rescue successes. Similarly, 31 subjects were randomized to Placebo, but only 26 out of the 31 subjects were prior IGIV-C responders or rescue successes.|||weeks||Standard Deviation|Mean
2837531|NCT00220740|Secondary|Mean Change in Grip Strength During the Efficacy Period||6 months|Intent-to-treat|||kilopascal||Standard Deviation|Mean
2837532|NCT00220740|Secondary|Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period|Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)|6 months|Intent-to-treat|||Millivolts||Standard Deviation|Mean
2837533|NCT00220740|Primary|Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period|"The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.~Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.~INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.~INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help"|6 months|The Intent-to-Treat Population was defined as all randomized subjects. This population was the primary efficacy population to be analyzed.|||percentage of responders|||Number
2837534|NCT00220727|Primary|Change From Baseline in Platelet Levels||24 hours Post infusion and Day 7||||Giga/L||Standard Deviation|Mean
2837535|NCT00220727|Primary|Red Blood Cells|Red blood cells as a measure to assess hemolysis|24 hrs after treatment||||10^12 cells/L||Standard Deviation|Mean
2837536|NCT00220727|Primary|Hematocrit|Hematocrit as a measure to assess hemolysis|24 hrs after treatment||||percentage of blood||Standard Deviation|Mean
2837537|NCT00220727|Secondary|Number of Subjects With Infusion Related Adverse Events||48 hours after treatment||||participants|||Number
2837538|NCT00220727|Primary|Free Hemoglobin|Free hemoglobin as a measure to assess hemolysis.|24 hours after treatment||||g/dL||Standard Deviation|Mean
2837539|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Week 12||||units on a scale||Standard Deviation|Mean
2837540|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Baseline||||units on a scale||Standard Deviation|Mean
2837541|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Baseline||||units on a scale||Standard Deviation|Mean
2837542|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Baseline||||units on a scale||Standard Deviation|Mean
2837543|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Week 12||||units on a scale||Standard Deviation|Mean
2837544|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Week 12||||units on a scale||Standard Deviation|Mean
2837545|NCT00220636|Secondary|Change in Beck Depression Inventory (BDI) Score|"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.~Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment."|baseline and 12 weeks|Number of participants for whom data was available after starting aripiprazole augmentation|||points on BDI scale||Standard Deviation|Mean
2837546|NCT00220636|Secondary|Change in Global Assessment of Functioning Scale (GAFS)|Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.|baseline and 12 weeks|All subjects (14/15) for whom data was available after starting aripiprazole augmentation|||points on GAFS scale||Standard Deviation|Mean
2837547|NCT00220636|Secondary|Clinical Global Impressions Improvement Scale (CGI)|clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)|12 weeks|all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects)|||units on CGI scale||Standard Deviation|Mean
2837548|NCT00220636|Primary|Hamilton Depression Rating Scale (HDRS)|"Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression responded after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12."|12 weeks|Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects).|||participants|||Number
2837558|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) of Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2837549|NCT00219557|Secondary|Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.|Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.|||units on a scale||Standard Deviation|Mean
2837550|NCT00219557|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. ''n'' signifies the number of participants evaluable for the respective scale at the respective time point.|||units on a scale||Standard Deviation|Mean
2837551|NCT00219557|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.|Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Percent chance of survival||95% Confidence Interval|Number
2837552|NCT00219557|Secondary|Progression-free Survival (PFS)|"Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Days||95% Confidence Interval|Number
2837553|NCT00219557|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks|Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
2837554|NCT00219557|Secondary|Percentage of Participants With Overall Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non-target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2837555|NCT00219557|Secondary|Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks|||||||
2837556|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Gemcitabine|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2837557|NCT00219557|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2837561|NCT00219557|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.|||ng*hr/mL||Standard Deviation|Mean
2837562|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2837563|NCT00219557|Secondary|Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 Baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2837564|NCT00219557|Secondary|Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2837565|NCT00219557|Primary|Overall Survival (OS)|Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant|Phase 2 intent to treat (ITT) population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.|||Days||95% Confidence Interval|Median
2837566|NCT00219544|Secondary|Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components|two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)|Week 9||||score on scale||Standard Error|Least Squares Mean
2837567|NCT00219544|Secondary|Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.|Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.|Week 9|FAS population|||score on scale||Standard Error|Least Squares Mean
2837568|NCT00219544|Secondary|Patient Global Impression of Change (PGIC) Categories by Number of Subjects|"Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from~1 (very much improved) to 7 (very much worse)."|Week 9|FAS Population|||participants|||Number
2837569|NCT00219544|Secondary|Change in Pain Treatment Satisfaction Scale (PTSS)|"Mean Change: score from observation minus score from randomization: PTSS Impact module of 8-items & Satisfaction module of 6-items; item scores 1-5.~Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100~=best possible response: Score =[(5 - mean non-missing items)*100]/4."|Week 9||||score on scale||Standard Error|Least Squares Mean
2837570|NCT00219544|Secondary|Change in Hospital Anxiety and Depression Scale Responses|Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.|Week 9|FAS population|||score on scale||Standard Error|Least Squares Mean
2837571|NCT00219544|Secondary|Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)|Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 4, Week 9||||scores on a scale||Standard Error|Least Squares Mean
2837572|NCT00219544|Secondary|Change in Sleep Interference Scores During Double Blind Treatment Phase|"Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|9 weeks|Full Analysis Set (FAS)|||score on scale||Standard Error|Least Squares Mean
2837573|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase|"Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|Week 9||||score on scale||Standard Deviation|Mean
2837630|NCT00218439|Other Pre-specified|Plasma Epinephrine Concentration Response to Stress|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||pg / ml||Standard Error|Mean
2837574|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase|"Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|0 and 4 weeks|Last observation carried forward (LOCF) approach for patients who do not complete the study will be adopted. This is defined as the mean of the last 7 diary scores while on Double-Blind study drug, up to and including the day after the last day on drug (excluding the taper phase).|||score on scale||Standard Deviation|Mean
2837575|NCT00219544|Secondary|Mean Sleep Interference Score|"Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|Week 9|FAS population.|||score on scale||Standard Error|Least Squares Mean
2837576|NCT00219544|Secondary|Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)|Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .|Week 9||||participants|||Number
2837577|NCT00219544|Secondary|Categorized Daily Pain Score|Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)|Week 9|Number of subjects analyzed for each pain category.|||days||Standard Deviation|Mean
2837578|NCT00219544|Secondary|Mean Pain Score for Non-responders at End of Single-blind Treatment Phase|"Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 (no pain) to 10 (worst possible pain). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline."|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.|||score on scale||Standard Deviation|Mean
2837579|NCT00219544|Secondary|Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.|"Daily Pain Rating Score:11-point numerical scale 0 (no pain) to 10 (worst possible pain). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline."|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.|||score on scale||Standard Deviation|Mean
2837580|NCT00219544|Secondary|Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment|"Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)."|Week 4 (end of single-blind treatment phase)|256 subjects entered the single-blind treatment phase, one subject did not have enough DPRS assessments for calculation.|||participants|||Number
2837581|NCT00219544|Secondary|Change in Pain Scores During Double Blind Treatment Phase|"Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)."|9 weeks|Full Analysis Set (FAS)|||score on scale||Standard Error|Least Squares Mean
2837582|NCT00219544|Secondary|Weekly Mean Pain Scores During the Double Blind Treatment Phase|"Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)."|Week 4 - 9|FAS population.|||score on scale||Standard Deviation|Mean
2837583|NCT00219544|Secondary|Weekly Mean Pain Scores During the Single-blind Treatment Phase|"Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)."|0 and 4 weeks|Full Analysis Set (FAS)|||score on scale||Standard Deviation|Mean
2837584|NCT00219544|Primary|Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase|"Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)."|9 weeks|Full Analysis Set (FAS) = Intent-to-Treat (ITT) population, defined as all subjects who are randomized into the Double-Blind treatment phase, who receive at least one dose of Double-Blind study medication and complete at least one postrandomization efficacy assessment.|||score on scale||Standard Error|Least Squares Mean
2837585|NCT00219349|Secondary|Change in Beck Depression Inventory-II|total score ranges from 0 (not depressed) to 63 (most severe)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
2837586|NCT00219349|Secondary|Change in Hamilton Rating Scale for Depression|24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
2837587|NCT00219349|Secondary|Clinical Global Impressions-Improvement Index|This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)|week 26||||units on a scale||Standard Deviation|Mean
2837588|NCT00219349|Primary|Change in State-Trait Anxiety Inventory, State Subscale|only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
2837589|NCT00219349|Primary|Change in Penn State Worry Questionnaire|total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)|week 14 to week 26||||units on a scale||Standard Deviation|Mean
2837590|NCT00219349|Primary|Change in Generalized Anxiety Disorder Severity Scale|measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.|week 14 to week 26||||units on a scale||Standard Deviation|Mean
2837591|NCT00219349|Primary|Change in Clinical Global Impressions-Severity Index|7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.|week 14 to week 26||||units on a scale||Standard Deviation|Mean
2837592|NCT00219349|Primary|Change in Hamilton Anxiety Rating Scale Score|The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.|week 14 to week 26|see above: Patients who completed the CBT phase and started escitalopram treatment|||units on a scale||Standard Deviation|Mean
2837593|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQ-39 scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837594|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment|Quality of life was assessed with the Parkinson's Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQUALIF scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837595|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment UPDRS part III scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837596|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQ-39 scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837597|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQ-39 scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837598|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5-point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 UPDRS part III scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837599|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8|Quality of life was assessed with the Parkinson's Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQUALIF scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837600|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to Week 4|Quality of life was assessed with the Parkinson's Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQUALIF scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837601|NCT00219284|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 UPDRS part III scores were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2837602|NCT00219141|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.|Baseline the end of study (Week 36)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mm Hg||Standard Error|Least Squares Mean
2837603|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.|||mm * ms||Standard Deviation|Mean
2837604|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.|||mm||Standard Deviation|Mean
2837605|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mL||Standard Deviation|Mean
2837606|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||percent||Standard Deviation|Mean
2837607|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||g||Standard Deviation|Mean
2837608|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mm||Standard Deviation|Mean
2837609|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mm||Standard Deviation|Mean
2837610|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mm||Standard Deviation|Mean
2837611|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mL||Standard Deviation|Mean
2837631|NCT00218439|Other Pre-specified|Heart Rate Response to Stress|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||beats/minute||Standard Error|Mean
2837612|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||mL||Standard Deviation|Mean
2837613|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||g/m^2||Standard Deviation|Mean
2837614|NCT00219141|Primary|Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)|Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.|Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.|||g/m^2||Standard Error|Least Squares Mean
2837615|NCT00218634|Secondary|CD4+ Lymphocyte Count at 3-month Follow-up Assessment.|CD4+ lymphocyte cell count at 3-month follow-up assessment.|3-month assessment|We used intent to treat for all analysis.|||cells/mm3||Standard Deviation|Mean
2837616|NCT00218634|Secondary|HIV Viral Load at 3-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.|3-month assessment|We used intent to treat for all data analysis.|||"log10 copies/mL"||Standard Deviation|Mean
2837617|NCT00218634|Secondary|Clinician-assessed Depression at 12-month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|12-month follow-up assessment|We used intent to treat for all data analysis.|||Units on scale||Standard Deviation|Mean
2837618|NCT00218634|Primary|Percent Medication Adherence at 12-month Follow-up Assessment|Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|12-month follow-up assessment|We used intent to treat for all data analysis.|||percent (doses taken/doses prescribed)||Standard Deviation|Mean
2837619|NCT00218634|Secondary|CD4+ Lymphocyte Count at 12-month Follow-up Assessment.|CD4+ lymphocyte cell count at 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.|||cells/mm^3||Standard Deviation|Mean
2837620|NCT00218634|Secondary|HIV Viral Load at 12-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.|||log10 copies/mL||Standard Deviation|Log Mean
2837621|NCT00218634|Secondary|Clinician-assessed Depression Rating at 3 Month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|3 month follow-up|We used intent to treat for all data analysis.|||Units on scale||Standard Deviation|Mean
2837622|NCT00218634|Primary|Percent Medication Adherence at 3-month Follow-up Assessment|Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|3-month assessment|We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.|||percent (doses taken/doses prescribed)||Standard Deviation|Mean
2837623|NCT00218543|Primary|ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)|Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.|measured during 12 weeks or length of study participation|Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed|||scores on a scale||Standard Deviation|Mean
2837624|NCT00218543|Primary|the Adult ADHD Rating Scale (AARS) (30% Reduction)|AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.|baseline compared to rating at week 12 or last rating during study participation|All participants|||percent of participants|||Number
2837625|NCT00218491|Primary|Number of Participants That Achieved Study Compliance|Drug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml|8 weeks||||Participants|||Count of Participants
2837626|NCT00218465|Primary|Days to Relapse Within the 60 Days Following Randomization||60 days||||days||Standard Deviation|Mean
2837627|NCT00218465|Primary|Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial||5 weeks||||participants|||Number
2837628|NCT00218465|Primary|Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.||5 weeks||||days||Standard Deviation|Mean
2837629|NCT00218439|Other Pre-specified|Plasma Norepinephrine Concentration Response to Stress|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||pg / ml||Standard Error|Mean
2837632|NCT00218439|Other Pre-specified|Diastolic Blood Pressure Response to Stress|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||mm Hg||Standard Error|Mean
2837633|NCT00218439|Primary|Systolic Blood Pressure Response to Stress|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo||||mmHg||Standard Error|Mean
2837634|NCT00218426|Secondary|Benzodiazepine Drug Use|Number of subjects with benzodiazepine drug use in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).|baseline||||Participants|||Count of Participants
2837635|NCT00218426|Secondary|Marijuana Drug Use|Number of subjects with Marijuana use in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).|baseline||||Participants|||Count of Participants
2837636|NCT00218426|Secondary|Cocaine Drug Use|Number of subjects with cocaine drug use in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).|baseline||||Participants|||Count of Participants
2837637|NCT00218426|Secondary|Amphetamine Drug Use|Number of subjects who used Amphetamine in the past 90 days at baseline as measured by the TimeLine Follow-back Form (TLFB) . The TLFB is an instrument that assesses substance use over a specified period of time (Sobel & Sobel, 1992).|baseline||||Participants|||Count of Participants
2837638|NCT00218426|Secondary|Global Assessment Form (GAF)|Assessment of overall psychiatric function comprises Axis V in the DSM-IV (DSM-IV, 1994). GAF scores range from 0 to 100. A reasonably well-functioning person will score above 70; serious impairment is below 50.|baseline||||score on a scale||Standard Deviation|Mean
2837639|NCT00218426|Secondary|HIV Risk (Baseline)|The Risk Assessment Behavior (RAB), is an HIV risk Scale. The Total Score is scored by adding the values that correspond to the responses selected by the subject for the items asked. This highest total score is 40 (highest risk), and the lowest score = 0 (no risk). This assessment has 2 Subsections: 1) Drug Risk = 8 questions (lowest Drug Risk score = 0 (no risk), and highest drug risk score = 22 =(greatest risk), 2) 10 Sex Risk questions: scores are 0 = no risk, and 18 = highest risk). Total RAB Score = Drug Risk Total + Sex Risk Total (0 = no risk, 40 = highest). See: Risk Assessment Battery (RAB) Scoring System, https://www.med.upenn.edu/hiv/assets/user-content/.../RABScoringv2.112.21.95.doc|baseline||||score on a scale||Standard Deviation|Mean
2837640|NCT00218426|Secondary|Composite Score of Psychiatric Problems|composite score is a decimal score; with 0 = no problems, 1 = the most problems based on the Addiction Severity Index composite score of 11 indexed questions.|6 months|mean of composite score|||composite score||Standard Deviation|Mean
2837641|NCT00218426|Secondary|Use of Alcohol|use of alcohol grams per day|6 months||||grams per day||Standard Deviation|Mean
2837642|NCT00218426|Secondary|Positive Opioid Urine Test|missed urine tests were imputed to be positive for opiates|6 months|missing = positive; results negative for opioids|||urine tests|urine tests|95% Confidence Interval|Number
2837643|NCT00218426|Secondary|Number of Subjects Who Dropped Out of Treatment|Kaplan-Meier survival curves for the event of subjects who dropped out of treatment|6 months||||participants|||Number
2837644|NCT00218426|Primary|Retention Without Relapse to Heroin Addiction (Measured at Month 6)|Survival analysis (Kaplan-Meier survival functions with log-rank Cox-Mantel criteria for group comparison was used to determine the primary outcome of retention, defined as not missing 2 consecutive counseling sessions and not having a relapse. Because this outcome combined patients who failed to keep appointments with those who kept appointments but relapsed, the proportion of non-survivors attributable to proven relapse.|6 months|Subjects who remained in treatment without relapse. remaining in treatment = 6 months manualized clinical counseling, plus medication.|||Participants|||Count of Participants
2837645|NCT00218387|Primary|Percent of Participants With New Use|New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.|8 weeks|The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.|||Percentage of participants|||Number
2837646|NCT00218387|Primary|Number of Cocaine Non-use Days|Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.|8 weeks|The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.|||Number of Days||Standard Error|Mean
2837647|NCT00218335|Primary|Talked About Hepatitis to Drug Buddies||18 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837648|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837649|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in Past Month)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837650|NCT00218335|Primary|Injecting Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837651|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837652|NCT00218335|Primary|Shared Cooker When Preparing Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837653|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837654|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837655|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837656|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837657|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837658|NCT00218335|Primary|Talked About Responding to Overdose to Drug Buddies||6 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837659|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837660|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837661|NCT00218335|Primary|Any Sex Risk||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.|||participants|||Number
2837662|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 32|Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks||||percentage of randomized|||Number
2837663|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks||||percentage of randomized|||Number
2837664|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 26|Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|26 weeks|Intent to treat|||percentage of randomized|||Number
2837665|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)|26 week||||percentage of randomized|||Number
2837666|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 12|Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks||||percentage of randomized|||Number
2837667|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)|No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks|Intent to treat|||percentage of randomized|||Number
2837668|NCT00218062|Secondary|Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples||16 weeks||||% of riboflavin-positive urine samples|||Number
2837669|NCT00218062|Secondary|Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report||16 weeks||||percentage of pills taken|||Number
2837670|NCT00218062|Primary|Retention as Indicated by the Number of Participants Who Remained in the Study||16 weeks||||participants|||Number
2837671|NCT00218062|Primary|Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment||16 weeks||||participants|||Number
2837672|NCT00218062|Primary|Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment||16 weeks|All participants who received the first dose of study medication were included in this analysis.|||number of cocaine negative urines||Standard Deviation|Mean
2837673|NCT00218036|Secondary|Medication Compliance||12 weeks of treatment|The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.||||||
2837674|NCT00218036|Secondary|Retention||12 weeks of treatment|The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.||||||
2837675|NCT00218036|Primary|Confirmed Abstinence From Cocaine||12 weeks of treatment|The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.||||||
2837676|NCT00218023|Primary|Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline|Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.|3 times per week (Monday, Wednesday, and Friday) for 12 weeks||||Mean % of cocaine-positive urines||Standard Error|Mean
2837677|NCT00218023|Primary|Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline|Cocaine use was determined by assessing for the presence of benzoylecgonine in urine.|3 times per week (Monday, Wednesday, and Friday) for 12 weeks||||Mean % of cocaine-positive urines||Standard Error|Mean
2837678|NCT00217971|Primary|Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial|Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.|weeks 7 and 8||||participants|||Number
2837679|NCT00217724|Secondary|Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2||Duration of participation on study (up to one year)|||||||
2837680|NCT00217724|Primary|Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy|Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores|2 courses of chemotherapy (6 weeks)|Fourteen of the 18 patients enrolled received both cycles of therapy and were thus evaluable for the primary endpoint|||participants|||Number
2837681|NCT00217672|Secondary|Comparison of Safety and Toxicity|Evaluated using adverse event (AE) information. Detailed AE information is provided in the AE section.|When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study||||subjects|||Number
2837682|NCT00217672|Secondary|Comparison of Response Rates, Duration of Response, and Overall Survival||Time of death, up to 3 years|Response rate – the percentage of patients assigned to a treatment arm who experience a CR or PR. Duration of response – the interval from date of initial documented response (CR or PR) to the first documented date of disease progression. Overall survival – the interval from the date of registration and the date of death.|||months||95% Confidence Interval|Median
2837683|NCT00217672|Primary|Antitumor Activity Based on Time to Tumor Progression (TTP).||From randomization until tumor progression|76 participants were registered to the Treatment, 7 to arm A and 69 to arm B. 6 participants randomized to arm A elected to cross over to arm B once Avastin became available. 2 out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. Thus, the efficacy analysis performed on 67 patients.|||months||95% Confidence Interval|Median
2837684|NCT00217620|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2837685|NCT00217620|Primary|Objective Response (Confirmed, Complete and Partial)|Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.|Assessment performed every eight weeks until progression.|Eligible patients who had received any treatment were included in this analysis.|||participants|||Number
2837686|NCT00217620|Secondary|Four-month Progression-free Survival Rate||0 - 4 months|Eligible patients who had received any treatment were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2837687|NCT00217594|Primary|Response to Treatment - Hematologic Improvement or Complete Response|"Response to treatment at 3 months after the first dose of alemtuzumab. The parameters for hematologic improvement (HI) and complete response (CR) were defined according to the International Working Group (IWG) criteria. The IWG criteria for HI define specific responses of cytopenias in the 3 hematopoietic lineages: erythroid (HI-E), platelet (HI-P), and neutrophil (HI-N).7 The HIs are measured in patients with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or RBC-transfusion dependence, platelet count less than 100 × 109/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 × 109/L.~The parameters for CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more (in patients not receiving erythropoietin or transfusions), a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L."|3 months||||Participants|||Count of Participants
2837688|NCT00217581|Secondary|Overall Survival|Overall survival using the Kaplan-Meier method|Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years||||months||95% Confidence Interval|Median
2837689|NCT00217581|Secondary|Time to Treatment Failure|Time to treatment failure using the Kaplan-Meier method|Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months||||months||95% Confidence Interval|Median
2837690|NCT00217581|Secondary|Toxicity Profile|Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.|At 21 days following completion of study treatment||||Participants|||Count of Participants
2837691|NCT00217581|Secondary|Response Rate by RECIST Criteria|Percentage of Participants with response by RECIST criteria until progression|After every 2 cycles (1 cycle =21 days)||||percentage of responders||95% Confidence Interval|Number
2837692|NCT00217581|Primary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months||||months||95% Confidence Interval|Median
2837693|NCT00217490|Primary|Change in Percentage of Fat Consumed|Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.|Baseline and 3 months|Participants who returned for follow up visit|||Percentage of fat consumed||Standard Deviation|Mean
2837694|NCT00217490|Primary|Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months|Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.|Baseline and 3 months|Participant who returned for follow up visit|||number of servings per day||Standard Deviation|Mean
2837695|NCT00217464|Secondary|Number of Participants With Progressive Disease at Day +90|Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients|||participants|||Number
2837696|NCT00217464|Primary|Proportion of Patients Who Respond to Treatment.|Response is defined to be the clear slowing of the rate of increase of PSA levels with time|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2837697|NCT00217438|Secondary|Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2|Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|Up to day 56 after transplant|Patients who were treated per protocol.|||Grade 3-4 adverse events|||Number
2837698|NCT00217438|Primary|CR and Near CR Rates|"Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. Near Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey."|Up to 120 days after transplant|Per protocol, patients who completed the day 80-120 evaluation assessments.|||percentage of participants|||Number
2837699|NCT00217425|Secondary|3-Year Overall Survival|3-year overall survival is defined as the probability of patients surviving at 3 years from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
2837700|NCT00217425|Secondary|Overall Response Rate|Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Chesen, 1999).|Assessed after cycle 3, cycle 6, and cycle 8 (if given).|Eligible and treated|||proportion||95% Confidence Interval|Number
2837701|NCT00217425|Primary|12-Month Progression-Free Survival (PFS)|12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
2837702|NCT00217399|Secondary|Tumor Marker Analysis|Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-).|1 year|14 subjects had blood specimens available for analysis|||participants|||Number
2837703|NCT00217399|Secondary|Number of Participants With Adverse Events|Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0|1 year|All 35 patients enrolled in the study were assessed for adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0.|||participants|||Number
2837704|NCT00217399|Primary|Complete Response + Partial Response + Stable Disease > 24 Weeks|"Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking.~A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks."|24 weeks|Female patients with advanced or metastatic breast cancer. The protocol was initiated with intention to treat every patient enrolled with a sorafenib and anastrozole combination.|||participants|||Number
2837705|NCT00217087|Primary|Change in Quality of Life|Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36|end of study|25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis.|||participants|||Number
2837706|NCT00217087|Primary|Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.|"Whether or not positive fish markers measured by polysomy were associated with outcomes.~Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented."|12 months post therapy|4 participants in the PDT group completed at least 3 months of follow up but not 12 months|||participants|||Number
2837707|NCT00217087|Primary|Level of Dysplasia on Histology at 12 Months|All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus|12 months post therapy|4 participants in the photodynamic therapy group completed at least 3 but less than 12 months follow up post therapy, so they were not included in this analysis.|||paricipants|||Number
2837870|NCT00212888|Secondary|Magnitude of Viral Rebound|Magnitude of viral rebound is the amount of HIV viral load an infected person who was previously on ART and suppressed below clinical detection rebounds to following ART stoppage. This will typically be compared to the viral load before starting ART or Viral set-point discussed earlier.|Up to week 48||||log10 copies/ml||Inter-Quartile Range|Median
2837708|NCT00217022|Secondary|Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies|"The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale (normal (0), mildly increased (1), moderately increased (2), severely increased (3))."|Baseline (day 1 of study) and at eight weeks (approximately)|Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure.|||participants|||Number
2837709|NCT00217022|Primary|Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks|"Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of satisfactory control of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks."|Three out of last four weeks that the subject was on the study||||participants|||Number
2837710|NCT00216736|Post-Hoc|Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours|Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours|48 hours||||Participants|||Number
2837711|NCT00216736|Secondary|Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.|Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.|48 hours||||Participants|||Number
2837712|NCT00216736|Primary|Proportion of Patients With Recurrent Headache Within 48 Hours.|Proportion of patients who report recurrent headache within 48 hours, on telephone followup.|48 hours||||Partcipants|||Number
2837713|NCT00216736|Primary|Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.|Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.|48 hours||||Participants|||Number
2837714|NCT00216671|Secondary|Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12|Short Form Health Survey: A generic dual-ie, mental and physical health-scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.An additional 9 and 11 patients in the respective groups had missing SF-12 data.|||scores on a scale||Standard Deviation|Mean
2837715|NCT00216671|Secondary|Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)|Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initation group has missing GAF data.|||scores on a scale||Standard Deviation|Mean
2837716|NCT00216671|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a subject's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject's condition at a given time.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initiation group has missing CGI-S data.|||scores on a scale||Standard Deviation|Mean
2837717|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 12|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 12.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 9 and 23 patients in the respective groups had missing PANSS data.|||scores on a scale||Standard Deviation|Mean
2837718|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 6|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 6.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 3 and 5 patients in the respective groups had missing PANSS data at week 6.|||scores on a scale||Standard Deviation|Mean
2837719|NCT00216671|Primary|Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210.|at baseline and Week 26 or at premature discontinuation|Per Protocol analysis: all randomized patients who had no violation on eligibility criteria or no major protocol violation. This excluded 42 patients in the early and 34 in the late initiation group. 1 patient in the early initiation group had no PANSS at endpoint. The endpoint is the last post-baseline value of the patient.|||scores on a scale||Standard Deviation|Mean
2837734|NCT00216125|Secondary|Progression Free Survival|"A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival.~Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion."|Participants were monitored from treatment initiation until disease progression per RECIST or death||||months||95% Confidence Interval|Median
2837720|NCT00216476|Secondary|Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores|Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL.|Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. An additional 32, 32, and 2 subjects in the respective arms did not have SF-12 data.|||units on a scale||Standard Deviation|Mean
2837721|NCT00216476|Secondary|Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score|The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject's psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects).|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm, 11 of the quetipaine arm, and 1 of the aripiprazole arm. One additional subject in the risperidone LAI arm did not have CGI data.|||units on a scale||Standard Deviation|Mean
2837722|NCT00216476|Secondary|Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score|"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).~Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme)."|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. One additional subject in each the risperidone LAI and quetiapine arm did not have PANSS data.|||units on a scale||Standard Deviation|Mean
2837723|NCT00216476|Secondary|Mean Relapse Free Period (Exploratory/Aripiprazole)|As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 1 subject of the aripiprazole arm.|||days||Standard Error|Mean
2837724|NCT00216476|Primary|Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)|Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm and 11 of the quetiapine arm.|||days||Standard Deviation|Mean
2837725|NCT00216320|Primary|10 Meter Walking Speed Before and After Intervention.|Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks||||meters/second||Standard Deviation|Mean
2837726|NCT00216320|Primary|Physiological Cost Index Before and After Intervention.|PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks||||beats/minute||Standard Deviation|Mean
2837727|NCT00216320|Primary|Figure 8 Walking Speed Before and After Intervention.|Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks||||meters/second||Standard Deviation|Mean
2837728|NCT00216320|Secondary|Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO|Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference|12 weeks|per protocol (completers) analysis|||participants|||Number
2837729|NCT00216203|Secondary|Clinical Benefit Rate|Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)|12 months|Data was not collected or analyzed for this secondary objective.||||||
2837730|NCT00216203|Secondary|Toxicity and Safety Profile||12 months||||percentage of particpants|||Number
2837731|NCT00216203|Secondary|Median Survival Time||24 Months|27 participants had data sufficient to complete Median Survival Time analysis|||weeks||95% Confidence Interval|Median
2837732|NCT00216203|Primary|Time To Progression (TTP)|The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 Months|27 participants had enough data to complete TTP analysis|||Weeks||95% Confidence Interval|Median
2837733|NCT00216203|Primary|Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab|The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab|12 months|12 participants participated in the phase I portion of the trial.|||mg/m^2 every 21 days|||Number
2837735|NCT00216125|Primary|Overall Survival|A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.|Participants were measured from treatment initiation to death|The analysis cohort for the results reported below are based on a planned interim DSMB evaluation conducted in 2006. This evaluation concluded that further accrual was futile and the study should be terminated. The 203 subjects included in this analysis had data sufficiently mature at the time of the DSMB analysis.|||Months||95% Confidence Interval|Median
2837736|NCT00216099|Secondary|Time to Prostate-Specific Antigen (PSA)/Serological Progression|Serological Progression (sPD) - increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline|From study enrollment to progression per PSA criteria (for life)||||months||95% Confidence Interval|Median
2837737|NCT00216099|Secondary|Time to Progression|Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached*|Study enrollment until progression per RECIST or PSA (for life)||||months||95% Confidence Interval|Median
2837738|NCT00216099|Secondary|RFC1 G80A Genotype|Samples for RFC1 G80A pharmacogenetic analysis were collected at screening|Screening|Samples were available from 46 patients|||participants|||Number
2837739|NCT00216099|Secondary|Safety and Tolerability|Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.|18 months||||percentage of participants||95% Confidence Interval|Number
2837740|NCT00216099|Secondary|Rate of Clinical Benefit|"A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other:~> 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status."|Any time among evaluable subjects (for life)||||percentage of participants||95% Confidence Interval|Number
2837741|NCT00216099|Secondary|OBJECTIVE Overall Response Rate|"Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR)~Per RECIST:~CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits"|Start of treatment until disease progression/recurrence (for life)|Patients who had measurable disease per RECIST 1.1 at baseline. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan.|||percentage of participants||95% Confidence Interval|Number
2837742|NCT00216099|Secondary|Overall Survival||From study enrollment until death (for life)||||months||95% Confidence Interval|Median
2837743|NCT00216099|Primary|Best Overall PSA Response|"Best overall Prostate-Specific Antigen (PSA) response~PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline"|Start of treatment until disease progression/recurrence (for life)||||percentage of participatns||95% Confidence Interval|Number
2837744|NCT00216086|Secondary|Disease-Free Survival|The three year rate of Disease-Free Survival|36 months||||percentage||95% Confidence Interval|Number
2837745|NCT00216086|Secondary|Rate of Clinical Response|To determine the rate of clinical response following induction chemotherapy with capecitabine and irinotecan, and also the overall clinical response after the completion of chemoradiation with capecitabine.|36 months|Data for this secondary objective was not captured or analyzed due to the withdrawal of funding and subsequent termination of the study.||||||
2837746|NCT00216086|Secondary|Local and Distant Disease Recurrence Rates|To determine the rates of local and distant disease recurrence after treatment.|36 months||||percentage of particpants|||Number
2837747|NCT00216086|Primary|Pathological Complete Response (pCR) Rate|"· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.~Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients."|36 months||||percentage of patients||95% Confidence Interval|Number
2837748|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum Osteocalcin (OC)|Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration.|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||ug/L||Standard Deviation|Median
2837749|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum BAP|Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||ng/mL||Standard Deviation|Median
2837750|NCT00216060|Secondary|Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median|"Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing.~The bound HRP conjugate is measured by a luminescent reaction."|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||nmol BCE/mmol creatinine||Standard Deviation|Median
2837751|NCT00216060|Secondary|Three- Year Survival Rate||36 months||||percentage of participants||95% Confidence Interval|Number
2837752|NCT00216060|Secondary|Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)|"Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24.~Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution.~The compounds are detected as a result of their natural fluorescence with a fluorescence detector"|24 weeks|Number of Participants Analyzed reflects participants who had data available prior to study termination.|||nmol/mmol creatinine||Standard Deviation|Median
2837753|NCT00216060|Secondary|Time to Development of Hormone Refractory Disease||36 months|No data were collected for this Outcome Measure due to low accrual and subsequent study termination.||||||
2837754|NCT00216060|Secondary|Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL||36 months||||percentage of participants|||Number
2837755|NCT00216060|Primary|Numbers of SRE or Death Occurred Cumulatively|Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)|36 months||||participants|||Number
2837756|NCT00215943|Secondary|Overall Survival (OS), by Treatment Arm|"Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive.~Investigators had planned to accrue 176 participants to calculate median overall survival."|Up to 10 Years|All participants with evaluable follow-up data.|||months||Full Range|Median
2837757|NCT00215943|Secondary|Number of Participants With Progression Free Survival (PFS), by Treatment Arm|"Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; > 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.~> 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation.~>25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium > 11.5 mg/dL not attributable to other causes)."|4 Months|All evaluable participants|||participants|||Number
2837758|NCT00215943|Secondary|Number of Participants With Adverse Events, by Group|Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM).|4 Years, 7 Months|All evaluable participants|||participants|||Number
2837759|NCT00215943|Primary|Response Rates of VAD vs. Thalidomide/Dexamethasone|Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart.|End of Cycle 4 - 4 Months per Participant|All evaluable participants|||participants|||Number
2837760|NCT00215930|Secondary|Progression Free Survival (PFS)|PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants for Number at risk, Number of events, Number censored.|||Months||Full Range|Median
2837810|NCT00214539|Primary|Respiratory Adverse Events Per Subject|Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.|Baseline, 12 Months||||Respiratory Adverse Events/Subject|||Number
2837761|NCT00215930|Secondary|Overall Survival (OS)|Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants per protocol for Number at risk, Number of events, Number censored.|||Months||Full Range|Median
2837762|NCT00215930|Primary|Best Disease Response After a Maximum of Six Cycles.|Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.|24 Months|All participants were analyzed according to Response Evaluation Criteria in Solid Tumors (RECIST).|||Participants|||Number
2837763|NCT00215787|Primary|Presence of Reflux in Patients With Polyposis|Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.|one year||||participants|||Number
2837764|NCT00215683|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.|||participants|||Number
2837765|NCT00215683|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.|||participants|||Number
2837766|NCT00215657|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).|||participants|||Number
2837767|NCT00215657|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A|||participants|||Number
2837768|NCT00215644|Secondary|Matuzumab Serum Concentration||Baseline up to approximately 3 years|Data for this outcome was not collected from any of the participant; hence, no data available for reporting.||||||
2837769|NCT00215644|Secondary|Percentage of Participants With Anti-Matuzumab Antibodies||Baseline up to approximately 3 years|Data for this outcome was not collected from any of the participant; hence, no data available for reporting.||||||
2837770|NCT00215644|Secondary|Protein Biomarkers Levels||Baseline up to approximately 3 years|Data for this outcome was not collected from any of the participant; hence, no data available for reporting.||||||
2837771|NCT00215644|Secondary|Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score|EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported.|Baseline (Day 1), Post Baseline (Up to 3 Years)|"ITT population. Here, overall number of participants analyzed = participants who were evaluable for this outcome and Number analyzed = participants evaluable for specified timepoint for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2837772|NCT00215644|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.|Baseline until death due to any cause (up to approximately 3 years)|ITT population.|||months||95% Confidence Interval|Median
2837773|NCT00215644|Secondary|Progression-Free Survival|PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.|Baseline up to PD or death due to any cause (up to approximately 3 years)|ITT population.|||months||95% Confidence Interval|Median
2837774|NCT00215644|Secondary|Duration of Objective Response Assessed by Independent Review Committee|Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.|From first documented objective response to PD or death due to any cause (up to approximately 3 years)|ITT population.|||months||95% Confidence Interval|Median
2837775|NCT00215644|Primary|Percentage of Participants With Objective Response Assessed by Independent Review Committee|Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.|Baseline up to PD or death due to any cause (up to approximately 3 years)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2837776|NCT00215553|Secondary|Days in ICU|Number of days in ICU|Through 28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."|||days||Standard Deviation|Mean
2837777|NCT00215553|Secondary|Mortality||Through 28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."|||participants|||Number
2837778|NCT00215553|Primary|Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.||Through 28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."|||participants|||Number
2837779|NCT00215540|Secondary|Days in Hospital|The number of days spent in the hospital through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||days||Standard Deviation|Mean
2837780|NCT00215540|Secondary|Incidence of Death or BPD at 28 Days|Death or BPD, defined as oxygen requirement at 28 days of life|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
2837781|NCT00215540|Secondary|Area Under the Curve for Mean Arterial Pressure (MAP)|AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||arterial pressure (mm Hg)*hour||Standard Deviation|Mean
2837782|NCT00215540|Secondary|Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||Percent O₂*hour||Standard Deviation|Mean
2837783|NCT00215540|Secondary|Duration of Supplemental Oxygen|Number of days receiving supplemental oxygen through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||days||Standard Deviation|Mean
2837784|NCT00215540|Secondary|Days Receiving Mechanical Ventilation (MV)|Number of days receiving mechanical ventilation|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||days||Standard Deviation|Mean
2837785|NCT00215540|Secondary|BPD at 36 Weeks|BPD at 36 weeks PMA as determined by the need for supplemental oxygen|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
2837786|NCT00215540|Secondary|BPD at 28 Days|BPD at 28 days of life, as determined by the need for supplemental oxygen|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
2837787|NCT00215540|Primary|All-cause Mortality||36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
2837788|NCT00215540|Primary|Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks|Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age|36 weeks post-menstrual age (PMA)|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)|||participants|||Number
2837789|NCT00215150|Primary|Brief Social Phobia Scale(BSPS)|An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.|Baseline, 8 and 16 weeks|The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.|||units on a scale||Standard Deviation|Mean
2837790|NCT00215137|Primary|Yale Brown Obsessive Compulsive Scale|The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.|Open Label Phase Baseline,Randomization Phase Baseline or Beginning||||units on a scale||Standard Deviation|Mean
2837791|NCT00214903|Primary|Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)|Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
2837792|NCT00214903|Primary|Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)|Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.|||participants|Participants||Number
2837793|NCT00214786|Secondary|The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey|Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome.|12 months after transplantation||||Scores on a scale||Full Range|Median
2837794|NCT00214786|Secondary|Morbidity Related to the Islet Cell Infusion|Number of participants who experienced serious adverse events related to islet cell infusion|12months after transplantation||||participant|||Number
2837795|NCT00214786|Secondary|Morbidity Related to the Immunosuppression Regimen|Number of participants who experienced serious adverse events related to immunosuppression regimen|12 months after transplantation||||participant|||Number
2837796|NCT00214786|Secondary|Renal Function|Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL)|12 months after transplantation||||ml/min||Standard Error|Mean
2837797|NCT00214786|Secondary|The Number of Islet Cell Infusions Needed to Achieve Insulin Independence||12 months after transplantation||||number of infusion||Standard Error|Mean
2837798|NCT00214786|Secondary|Islet Cell Mass Obtained After Remote Site Processing|The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight.|At transplantation||||Islet Equivalent per kilogram||Standard Error|Mean
2837799|NCT00214786|Secondary|Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent|Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation.|12 months after transplantation||||Percent decrease compared to baseline||Standard Error|Mean
2837800|NCT00214786|Secondary|Incidence of Hypoglycemic Episodes|Blood glucose <70 mg/dl, number of times reported per month|12 months after transplantation||||episodes per month||Standard Error|Mean
2837801|NCT00214786|Secondary|Presence or Absence of Hypoglycemic Unawareness|Number of patients who achieved absence of hypoglycemic unawareness|12 months after transplantation||||participants|||Number
2837802|NCT00214786|Primary|Achievement of Insulin Independence at 12-month Post Transplant|To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation|12 months post transplant||||participant|||Number
2837803|NCT00214539|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Quality of Life Questionnaire (AQLQ) score. The AQLQ is a self-administered patient questionnaire that assesses four aspects or domains of daily life for patients with asthma: symptoms, emotional function, activity limitations, and environmental stimuli. The AQLQ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
2837804|NCT00214539|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Control Questionnaire (ACQ) score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). The ACQ is based on a one-week recall period. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
2837805|NCT00214539|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
2837806|NCT00214539|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
2837807|NCT00214539|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Total Symptom Score. The Total Symptom Score comprises the sum of six asthma symptom measurements recorded in a Daily Diary. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom Score represents better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
2837808|NCT00214539|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in use of rescue medications. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months||||Puffs/7 Days||Standard Deviation|Mean
2837809|NCT00214539|Secondary|Use of Maintenance Medications (Change From Baseline)|Percent Change from Baseline at 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visit in dose of inhaled and/or oral corticosteroids.|Baseline, 12 Months||||Percent||Standard Deviation|Mean
2837811|NCT00214526|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
2837812|NCT00214526|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID).|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
2837813|NCT00214526|Secondary|Use of Maintenance Medications (Change From Baseline)|Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists).|Baseline, 12 Months||||Subjects|||Number
2837814|NCT00214526|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study.|Baseline, 12 Months||||Puffs/7 Days||Standard Deviation|Mean
2837815|NCT00214526|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months||||Units on a scale||Standard Deviation|Mean
2837816|NCT00214526|Secondary|Peak Expiratory Flow (Morning and Evening) (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months||||L/min||Standard Deviation|Mean
2837817|NCT00214526|Secondary|Methacholine PC20 (Change From Baseline)|"Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in PC20 - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more responsive or hyperresponsive the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive."|Baseline, 12 Months||||mg/mL||95% Confidence Interval|Geometric Mean
2837818|NCT00214526|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
2837819|NCT00214526|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months||||Percent Change||Standard Deviation|Mean
2837820|NCT00214526|Primary|Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)|Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.|Baseline, 12 Months||||Exacerbations/Subject/Week||Standard Deviation|Mean
2837821|NCT00214500|Secondary|α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96|Leukocytes were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole [nmol] 4-MU/hr) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.|Baseline, Week 12 (end of treatment period), Week 96 (end of extension period)|PD Population: all eligible-enrolled participants who received at least 1 dose of study drug on Day 1, and who had a non-missing baseline and at least 1 non-missing postbaseline PD parameter recorded. Participants who discontinued prior to the specified time point were not analyzed because no data were available.|||nmol 4-MU/hr/mg protein|||Number
2837822|NCT00214500|Secondary|PK: Area Under The Concentration Versus Time Curve (AUC) After Administration Of Migalastat|The AUC from time zero to 12 hours (hr) postdose (AUC0-12) was evaluated in plasma following a single dose of migalastat 25, 100, and 250 mg on Days 1, 15, and 29, respectively. In addition, AUC0-12 was assessed following multiple doses (14 days) of migalastat 25, 100, and 250 mg on Days 14, 28, and 42, respectively.|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, and 10 hr (postdose)|PK Population: all eligible-enrolled participants who received study drug and had at least 1 postbaseline PK parameter recorded. One participant discontinued prior to receiving doses of migalastat 100 and 250 mg.|||nanograms*hr/milliliters (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2837869|NCT00212888|Secondary|HIV-specific Immune Function||at week 48|Data not collected for this assessment.||||||
2837871|NCT00212888|Secondary|Viral Set-point|Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.|Up to week 48|Only participants whose viral loads reached a steady state are included in the analysis.|||log10 copies/ml||Inter-Quartile Range|Median
2837823|NCT00214500|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 96 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through Week 96|Safety Population: all eligible-enrolled participants who received at least 1 dose of study drug. 6 participants were dosed screen failures, and were not included in the safety analysis.|||Participants|||Count of Participants
2837824|NCT00214487|Secondary|Changes in Axial Length at One Year.||One year|||||||
2837825|NCT00214487|Secondary|Changes in Cycloplegic Subjective Refraction in One Year||One year|||||||
2837826|NCT00214487|Secondary|Relationship Between Residual Fixation Disparity and Myopia Progression.||One year|||||||
2837827|NCT00214487|Secondary|Changes in Manifest Refraction at One Year.||One year|||||||
2837828|NCT00214487|Secondary|Keratometric Changes at One Year.||One year|||||||
2837829|NCT00214487|Primary|Changes in Cycloplegic Autorefraction in One Year.||One year||||Diopters||Standard Deviation|Mean
2837830|NCT00214461|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post first vaccination|Safety assessments were on the safety population.|||Participants|||Number
2837831|NCT00214461|Secondary|Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.|Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject's specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).|Day up to Day 236 post first vaccination|Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.|||Participants|||Number
2837832|NCT00214422|Secondary|Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria|Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage.|At median follow-up, approximately 28 months following radiation||||Participants|||Count of Participants
2837833|NCT00214422|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 8 years and 3.5 months.||||Participants|||Count of Participants
2837834|NCT00214422|Secondary|Number of Participants With a Dose Limiting Toxicity (DLT)|An acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.|Within 3 months after completion of radiation||||Participants|||Count of Participants
2837835|NCT00214422|Secondary|Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria|Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium).|At median follow-up, approximately 28 months following radiation||||Participants|||Count of Participants
2837836|NCT00214422|Primary|Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3|Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.|Completion of Treatment, an average of 8.5 weeks|The MTD of this study was not reached. The original principal investigator left the National Institutes of Health and we are unable to determine why the outcome was not met.||||||
2837837|NCT00214422|Primary|Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)|Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days.|At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy|6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.|||Participants|||Count of Participants
2837838|NCT00214383|Secondary|Improvement in Asthma Control|A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.|||Likert scale||95% Confidence Interval|Mean
2837839|NCT00214383|Primary|Number of Symptom-free Days|A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.|||Days||95% Confidence Interval|Mean
2837840|NCT00214383|Primary|Percentage Changed in Adherence Score|A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.|||Percent change||95% Confidence Interval|Mean
2837841|NCT00214201|Other Pre-specified|WBC|White Blood Cell count|36 months +/- 60 days||||K/ul||Standard Deviation|Mean
2837842|NCT00214201|Secondary|Serum Creatinine at 36 Months (End of Study)||36 months +/- 60 days||||mg/dl||Standard Deviation|Mean
2837843|NCT00214201|Primary|Number of Participants With Biopsy Proven Rejection||3 years||||participants|||Number
2837844|NCT00214149|Secondary|To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years||3 years|No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.||||||
2837845|NCT00214149|Primary|To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT||5 years|No data are available as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed. Sincere efforts were made to obtain the data for reporting, however, no data are available.||||||
2837846|NCT00214136|Secondary|To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival|Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.|5 years|Data was not collected for this outcome measure. Results can not be reported or analyzed.||||||
2837847|NCT00214136|Primary|Number of Participants Experiencing Expected Toxicities|Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.|Up to 5 years|Only 25 of 30 participants met the minimum follow up thresholds at the time of analysis; the 5 most recently accrued participants' data was not analyzed and is not reflected.|||Participants|||Count of Participants
2837848|NCT00214097|Secondary|Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years|The SQLI is composed of five items (activity, daily living, health, support, outlook) scored utilizing a numerical scale of 0-2. Standard scoring was also used for the SQLI survey (total score range 0-10) where higher score indicate increased QoL.|Baseline and 3 years|Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included.|||scores on a scale||Standard Deviation|Mean
2837849|NCT00214097|Secondary|International Index of Erectile Function (IIEF) Score at Baseline and 3 Years|The IIEF is a 15-item survey where 9-items are scored 0-5 and 6-items are scored 1-5 with a total range of 6-75. The standard scoring mechanism was used for IIEF, where the QoL items corresponded to the following domains: erectile function (score range 1-30), orgasmic function (score range 1-10), sexual desire (score range 2-10), intercourse satisfaction (score range 0-15), and overall satisfaction (score range 2-10). Higher numbers indicate increased QoL.|Baseline and 3 years|Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included.|||scores on a scale||Standard Deviation|Mean
2837850|NCT00214097|Secondary|Fox Chase Bladder Survey at Baseline and 3 Years|The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life. Results for the Bladder Section are reported here.|Baseline and 3 years|Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included.|||scores on a scale||Standard Deviation|Mean
2837851|NCT00214097|Secondary|Fox Chase Bowel Survey at Baseline and 3 Years|The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life (QoL). Results for the Bowel Section are reported here.|Baseline and 3 years|Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included.|||scores on a scale||Standard Deviation|Mean
2837852|NCT00214097|Secondary|Biochemical Progression-free Survival Based on PSA Surveillance|Patients will be considered to be without biochemical recurrence if either the Prostate-specific antigen (PSA) is still declining or the PSA nadir has been reached and is below 1.0ng/ml|up to 15 years from enrollment||||percentage of participants||95% Confidence Interval|Number
2837853|NCT00214097|Primary|Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up|To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate|from 90 days post XRT through last follow-up visit (up to 3 years)||||Participants|||Count of Participants
2837854|NCT00214097|Primary|Number of Participants Who Experience Grade 3 or Higher Acute Toxicities|To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher.|90 days post radiation treatment||||Participants|||Count of Participants
2837855|NCT00214045|Primary|Visual Analog Scale for Pain|The Visual Analog Scale for pain ranges from 1 to 5, with higher scores indicating higher pain. Results report the average of two measures, taken during procedure and 1 week post-procedure.|During procedure and 1 week post-procedure|Per protocol.|||Units on a Scale||Standard Deviation|Mean
2837856|NCT00214019|Primary|Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge|Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.|Eosinophils are measured 24 hours after the subject has an antigen challenge|Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.|||Eosinophil percentage||Standard Deviation|Mean
2837857|NCT00213980|Secondary|Clinical Toxicity of ZA|Tolerability and side effects of ZA, measured by the number of participants experiencing adverse events.|Up to 1 year|Data was collected for the ZA arm at 9 time points, and for the Observation arm at 2 time points.|||Participants|||Count of Participants
2837858|NCT00213980|Secondary|Overall Survival|Number of participants who survived from the start of treatment through off treatment, up to 10 years.|Up to 10 years|Only participants who completed the trial (ZA = 29 and Observation = 26) were analyzed for this outcome measure.|||Participants|||Count of Participants
2837859|NCT00213980|Secondary|Rates of Metastases|Determine whether zoledronate is associated in rates of bone, visceral, and all distant metastases.|Up to 1 year|Data for this outcome measure was not collected.||||||
2837860|NCT00213980|Primary|Change in Bone Mineral Density (BMD) From Baseline to 1 Year|To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.|Up to 1 year|Fifty-six participants (ZA = 29, Observation = 27) were evaluable based on completing DXAs at 0, 6, and 12 months.|||grams per cubic centimeter||95% Confidence Interval|Mean
2837861|NCT00213239|Secondary|Incidence of Adverse Events.||Followed for the length of the procedure.||||Participants|||Count of Participants
2837862|NCT00213239|Primary|Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion|Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion|Movement measured at the time of lumbar puncture needle insertion.|Minimum effective dose of remifentanil to prevent movement during lumbar puncture insertion|||micrograms/kg||Standard Deviation|Mean
2837863|NCT00213148|Secondary|Number of Subjects With Clinical Pregnancy in Cycle 1|Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.|Up to 1 month|All Treated population included all treated subjects who received at least one tablet of study drug (CC or anastrozole).|||subjects|||Number
2837864|NCT00213148|Primary|Ovulation Rate in Cycle 1|Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy).|Up to 1 month|All Treated population included all treated subjects who received at least one tablet of study drug (clomiphene citrate or anastrozole).|||percentage of subjects|||Number
2837865|NCT00213135|Secondary|Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan|Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all participants who were randomized in the study.|||lesions||Standard Error|Least Squares Mean
2837866|NCT00213135|Secondary|Time to Disability Progression|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Tenth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|The ITT population included all participants who were randomized in the study.|||months|||Number
2837867|NCT00213135|Secondary|Percentage of Relapse-free Participants|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the EDSS or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Week 96|The ITT population included all participants who were randomized in the study.|||percentage of participants|||Number
2837868|NCT00213135|Primary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|The intention-to-treat (ITT) population included all participants who were randomized in the study.|||relapses per year||95% Confidence Interval|Number
2837876|NCT00212758|Primary|The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)|We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).|Day 1 & Day 8||||mcg/L||Standard Deviation|Mean
2837877|NCT00212446|Secondary|Gestational Age at Discharge|Gestational age at discharge.|until after childbirth||||weeks||Standard Deviation|Mean
2837878|NCT00212446|Secondary|The Length of NICU Stay|The length of Neonatal intensive care unit (NICU) stay|up to one month||||days||Standard Deviation|Mean
2837879|NCT00212446|Secondary|Apgars Score|"The 1-minute score determines how well the baby tolerated the birthing process. The 5-minute score tells the health care provider how well the baby is doing outside the mother's womb.~Five factors: Appearance (skin color), Pulse (heart rate), Grimace response (reflexes), Activity (muscle tone), Respiration (breathing rate and effort) are used to evaluate the baby's condition and each factor is scored on a scale of 0 to 2, with full scale from 0 to 10 being the best score"|1 minute and 5 minute after childbirth||||units on a scale||Standard Deviation|Mean
2837880|NCT00212446|Secondary|Pain During the Birthing Process||Until birthing process is complete|not collected||||||
2837881|NCT00212446|Secondary|Latency of Birth|Latency is defined as the time from admission into hospital until birth|Time until delivery, up to 4 weeks||||hours||Standard Deviation|Mean
2837882|NCT00212446|Primary|Number of Newborn With Fetal Heart Arrhythmias|Number of newborn with fetal heart arrhythmias noted|60 minutes||||newborns with fetal heart arrhythmias|||Number
2837883|NCT00212446|Primary|Uterine Contractions|The first 20 minutes are the control contraction period (C1). The second 20 minutes are the EI period, with a 10-second burst of current administered just prior to each expected contraction; expected contractions are determined by the timing of the C1 contractions and/or by the rise of the subjective tocodynamometer tracing above baseline levels. The third 20 minutes is the post-intervention control contraction period (C2).|20 minutes, 40 minutes, 60 minutes||||minutes||Standard Deviation|Mean
2837884|NCT00212355|Primary|Safety and Efficacy|Number of patients who have at least one adverse events. ALT Change|During study period (up to 96W )|The analysis was performed based on FAS population|||participants|||Number
2837885|NCT00212264|Primary|Percent Change in Incontinence Episodes Per Week on Bladder Diary|[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%|1 year|This outcome was to measure treatment durability. The no-treatment control group completed the study after the primary outcome was collected at 2 months. At that time, they were offered treatment for this burdensome condition outside the study. Only the 2 active treatment groups continued in the study for 1 full year.|||% change in episodes per week||95% Confidence Interval|Mean
2837886|NCT00212264|Primary|Percent Change in Incontinence Episodes on Bladder Diary|[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%|2 months||||% change in episodes per week||95% Confidence Interval|Mean
2837887|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252|Phase 1 - Age 12 Months|All those who completed the PSI 3 months after surgery and the PSI at age 12 months|||units on a scale||Standard Deviation|Mean
2837888|NCT00212134|Secondary|Adherence to Occlusion Therapy|Parental report of the number of hours children wore an patch to occlude the fellow eye.|Phase 1 - 12 months follow-up|Analysis is limited to those with at least 3 reports of adherence before 12 months of age.|||Hours patched per day||Standard Deviation|Mean
2837889|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.|Phase 1 - 3 months post surgery|All those who completed the PSI 3 months after surgery.|||units on a scale||Standard Deviation|Mean
2837890|NCT00212134|Secondary|Percent of Patients With 1 or More Adverse Events||Study enrollment to age 5 years||||percentage of patients||95% Confidence Interval|Number
2837891|NCT00212134|Secondary|Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery|Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery|Cataract surgery immediately after enrollment||||percentage of patients||95% Confidence Interval|Number
2837892|NCT00212134|Primary|Visual Acuity - Subjective Assessment at Age 10 Years.|Visual acuity assessment using the E-ETDRS protocol will be performed by certified site personnel; patients should be in their best optical correction as determined by the PI either recently or just before the EVA test|Phase 3 Age 10 Years||2020-09-30|09/2020||||
2837893|NCT00212134|Primary|Visual Acuity - Subjective Assessment at Age 4.5 Years.|Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.|Phase 2 - Age 4.5 Years|One patient in the intraocular lens group was lost to follow-up.at age 18 months. A second patient in that group had developmental delay and the visual acuity could not be assessed. Therefore, the visual acuity measurements at 4.5 years of age are reported for 55 of the 57 patients randomized to the intraocular lens group.|||logMAR units||Inter-Quartile Range|Median
2837919|NCT00211510|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks||||mmol/dl*min||Standard Deviation|Mean
2837920|NCT00211510|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26|Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.|Baseline and 26 weeks||||hypoglycemic events|||Number
2837894|NCT00212134|Primary|Visual Acuity|Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.|Phase 1 - Age 12 months|The number of participants was determined by the sample size estimate necessary to detect a 0.2 logMAR difference (2 lines on the Snellen chart) in the visual acuity between the two groups.|||logMAR units||Inter-Quartile Range|Median
2837895|NCT00211887|Secondary|Change in MRI Composite Score|MRI composite score (Z4 score) - the unweighted sum of the individual Z scores for enhanced tissue volume, T2 lesion burden, equivalence of the T1 hypointense lesion burden, normalized CSF (an inverse measure of atrophy with the appropriate sign so that all scores are directionally compatible - larger is worse) MRI enhancement status at baseline (0, 1-4, and 5 or more enhancing lesions)|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.|||z score||Standard Deviation|Mean
2837896|NCT00211887|Secondary|Change in the Multiple Sclerosis Functional Composite|"positive indicates improvement~The Multiple Sclerosis Functional Composite (MSFC) is a scale measuring pyramidal functions, sensory functions, cerebellar functions, bowel & bladder functions,brain stem functions, mental functions, and visual functions from 0 to 6.~0= normal 6= severe loss"|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.|||units on a scale||Full Range|Median
2837897|NCT00211887|Secondary|Confirmed Progression on the Expanded Disability Status Scale|"% with EDSS progression~Confirmed progression in a participant was defined as a 1.0 increase in the EDSS from baseline, when baseline <=5.0; or an increase of 0.5 from baseline, when baseline >=5.5, sustained for 6 months (2 successive quarterly visits), as assessed by the blinded EDSS examiner and confirmed centrally."|Baseline to Month 36||||percentage of participants|||Number
2837898|NCT00211887|Primary|ARR - PDEs|Annualized relapse rate of protocol-defined exacerbations Protocol defined relapse - an relapse seen within 7 days of onset, verified by the treating physician and independently observed as a change in EDSS by the examining physician. This relapse is defined as: the appearance of a new symptom or worsening of an old symptom, attributable to MS; accompanied by a change in the neurologic examination (defined as a 0.5 or greater increase in the EDSS over the last scheduled or unscheduled visit or a 2 point change in one functional system or a 1 point change in two functional systems, except bladder and cognitive changes); lasting at least 24 hours in the absence of fever; and preceded by stability or improvement for at least 30 days.|Baseline to Month 36||||relapses per year|||Number
2837899|NCT00211809|Secondary|Beck Anxiety Inventory|The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.|Baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
2837900|NCT00211809|Secondary|Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.|Baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
2837901|NCT00211809|Secondary|Brown Assessment of Beliefs Scale|The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.|Baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
2837902|NCT00211809|Primary|Body Dysmorphic Disorder Clinical Global Impressions Scale|The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
2837903|NCT00211809|Primary|Yale Brown Obsessive Scale|Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.|baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
2837904|NCT00211809|Primary|Body Dysmorphic Disorder Examination|Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.|baseline and up to 16 weeks||||units on a scale||Standard Deviation|Mean
2837905|NCT00211757|Primary|Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores|The Aberrant Behavior Checklist is designed to objectively identify five behavior sub scales through observation by the primary caregiver: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. The ABC was filled out by parents on a scale from 0-3 for each category. (0 being not a problem, 3 being severe problem). Scores from all sub scales were added (scoring 0-45 for Irritability subscale, 0-48 for Lethargy subscale, 0-21 for stereotypy scale, 0-48 for hyperactivity sub-scale, and 0-12 for inappropriate speech sub-scale) to obtain a total score.|Baseline and End of Study (week 15)||||units on a scale||Standard Deviation|Mean
2837906|NCT00211757|Primary|Number of Participants Reporting Improvement on the Clinical Global Impression|The CGI-I is a 7-point improvement scale. Ratings of 1 or 2 (responders) indicate a substantial reduction in symptoms. A rating of 3 (minimally improved) on the CGI is defined as a slight symptomatic improvement that is not deemed clinically significant; patients with such an improvement were not considered responders. Two versions of this test were used, one focused on irritability (primary outcome measure) and a general version CGI-I-autism focused on all symptoms including core symptom domains. The CGI-I irritability took into consideration the scores from the ABC-Irritability subscale, the OAS-M aggression and irritability subscales and information from open-ended questioning related to the degree of interference, nature, and range of behavioral problems at school and at home|Baseline to end of study (week 15)||||Participants|||Count of Participants
2837907|NCT00211692|Secondary|Overall Number of Serious Adverse Events||through end of study up to 72 weeks||||participants|||Number
2837908|NCT00211692|Secondary|Participants Achieving SVR Categorized by Time of Response|rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks|24 weeks after end of treatment|participants with analyzable data for this outcome|||participants|||Number
2837909|NCT00211692|Secondary|Number of Participants Discontinuing Early From Study Treatment||through end of study up to 72 weeks||||participants|||Number
2837910|NCT00211692|Primary|The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.|Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study|24 weeks after the end of treatment|Convenience sample for pilot trial. Analysis is intention to treat.|||participants|||Number
2837911|NCT00211536|Secondary|Low Blood Glucose Index (LBGI);|4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||mg/dL||95% Confidence Interval|Mean
2837912|NCT00211536|Secondary|Mean Amplitude of Glycemic Excursions (MAGE)|MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||mg/dL||95% Confidence Interval|Mean
2837913|NCT00211536|Secondary|Average Daily Blood Glucose|For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||mg/dL||95% Confidence Interval|Mean
2837914|NCT00211536|Primary|Incidence of Severe Hypoglycemia Events|The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.|12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.|||events|||Number
2837915|NCT00211536|Primary|Change in HbA1c and Compared Between Groups|To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.|Baseline and 12 months|The primary efficacy analysis set is the As treated data set and includes all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values.|||percent HbA1c||Standard Deviation|Mean
2837916|NCT00211510|Secondary|Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups|Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.|Baseline and 26 weeks||||Scores on a scale||Standard Deviation|Mean
2837917|NCT00211510|Secondary|Glucose Sensor Accuracy as Measured in the 722 Group|Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).|Baseline and 26 weeks||||percent of agreement|||Number
2837918|NCT00211510|Secondary|Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks||||mmol/dl*min||Standard Deviation|Mean
2837921|NCT00211510|Primary|Change in A1c From Baseline to 26 Weeks|Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 26 weeks||||Percent glycated hemoglobin||Standard Deviation|Mean
2837922|NCT00211237|Secondary|Rate of Subsequent Vertebral Body Fractures|Based on patients with at least 7 analyzable vertebrae.|1 month and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837923|NCT00211237|Secondary|Rate of Subsequent Vertebral Body Fractures||1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837924|NCT00211237|Secondary|Rate of Study Treatment-related Adverse Events Till Study Completion|"The study treatment-related AEs were defined as follows:~Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.~Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.~Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.~Unknown defined as the relationship of the AE to a Sponsor device could not be determined."|12 months|All of randomized subjects were included in safety population analysis.|||percentage of participants|||Number
2837925|NCT00211237|Secondary|Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline|"The study treatment-related AEs were defined as follows:~Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.~Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.~Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.~Unknown defined as the relationship of the AE to a Sponsor device could not be determined."|1 month|All of the randomized subjects were included in safety population analysis.|||percentage of participants|||Number
2837926|NCT00211237|Secondary|Change in Neurological Status From Baseline (Limb Strength)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837927|NCT00211237|Secondary|Change in Neurological Status From Baseline (Limb Strength)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837928|NCT00211237|Secondary|Change in Neurological Status From Baseline (Reflex Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:~absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3"|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837929|NCT00211237|Secondary|Change in Neurological Status From Baseline (Reflex Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:~absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3"|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837930|NCT00211237|Secondary|Change in Neurological Status From Baseline (Sensory Examination)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.|1 months, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837931|NCT00211237|Secondary|Change in Neurological Status From Baseline (Sensory Examination)|The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2838005|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
2837932|NCT00211237|Secondary|Change in Neurology Status From Baseline (Motor Strength)-Per Protocol|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:~absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5"|1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837933|NCT00211237|Secondary|Change in Neurology Status From Baseline (Motor Strength)|"The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:~absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5"|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837934|NCT00211237|Secondary|Back Pain Analgesics Used||Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837935|NCT00211237|Secondary|Back Pain Analgesics Used||Baseline, 7 days, and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837936|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.|Baseline, post-operation, 1 month, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||ratio||Standard Deviation|Mean
2837937|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||ratio||Standard Deviation|Mean
2837938|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Angles|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.|Baseline, post-operation, 1 month, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||degrees||Standard Deviation|Mean
2837939|NCT00211237|Secondary|Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month|Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||degrees||Standard Deviation|Mean
2837940|NCT00211237|Secondary|Ambulatory Status Change|Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.|Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837941|NCT00211237|Secondary|Ambulatory Status Change From Baseline to One Month|Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.|1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837942|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||days||Standard Deviation|Mean
2837943|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||days||Standard Deviation|Mean
2837944|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||days||Standard Deviation|Mean
2837945|NCT00211237|Secondary|Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||days||Standard Deviation|Mean
2837946|NCT00211237|Secondary|Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||percentage of participants|||Number
2837947|NCT00211237|Secondary|Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks|The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||percentage of participants|||Number
2837948|NCT00211237|Secondary|Change in Quality of Life|The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
2837949|NCT00211237|Secondary|Change in Quality of Life.|The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||units on a scale||Standard Deviation|Mean
2837950|NCT00211237|Secondary|Change in Back Pain|Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
2837951|NCT00211237|Secondary|Change in Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||units on a scale||Standard Deviation|Mean
2837952|NCT00211237|Secondary|Change in Functional Status Assessed With the Karnofsky Performance Scale|The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
2837972|NCT00211081|Primary|Change in Flow Mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||Percentage of brachial artery diameter||Standard Deviation|Mean
2837953|NCT00211237|Secondary|Change in Functional Status Assessed With the Karnofsky Performance Scale|The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).|Baseline and 1 month|Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.|||units on a scale||Standard Deviation|Mean
2837954|NCT00211237|Secondary|Change in Roland-Morris Disability Questionnaire Score|Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).|Baseline, 1 month, 3 months, 6 months, and 12 months|The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.|||units on a scale||Standard Deviation|Mean
2837955|NCT00211237|Primary|The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month|"The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.~The best score is 0 (no disability) and worst is 24 (maximum disability)"|Baseline and 1 Month|The analyses of change from Baseline included only patients in the modified Intent-to-Treat (mITT) population who provided evaluable data at both Baseline and at 1 month after receipt of the initially assigned study treatment.|||score on a scale||95% Confidence Interval|Mean
2837956|NCT00211185|Secondary|Percentage of Participants With Overall Survival|Overall Survival (OS) was defined as the time from the date of registration to the date of the participant's death. OS was determined by reviewing all participant's records every 6 months until the study was administratively closed or all participants died, whichever occurred first. Participants who were lost to follow-up but were still alive at the date of last contact were censored at the date of last contact. Participants who did not have a recorded date of death were censored for OS at the last date at which they were known to be alive.|From date of randomization until death, or administrative close of study, whichever came first, assessed up to 5 years 9 months|ITT population|||Percentage of participants|||Number
2837957|NCT00211185|Secondary|Progression-Free Survival|PFS was defined as the period of time from treatment start to the first documentation of PD, recurrence, or death. PD was defined as a greater than or equal to 50% increase from baseline in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or non-responders, or the appearance of any new lesions during or at the end of therapy. PFS was censored at the last date for which the response assessment resulted in the absence of PD for participants who did not demonstrate objective progression or recurrence. Participants who withdrew prior to evidence of disease progression or recurrence, PFS was censored at the last date assessment showed an absence of PD.|From the date of first dose of study drug until date of first documentation of PD, recurrence, or death from any cause, assessed up to 5 years 9 months|ITT population|||Weeks||Standard Deviation|Mean
2837958|NCT00211185|Secondary|Duration of Response|Duration of response was defined as the length of time from the first date at which the response criteria were met (taking the earliest date at which a PR, CRu, or the confirmed CR occurred) until the date that recurrent or PD or death was accurately documented, per the criteria defined for progression-free survival (PFS). All participants within the EA population who achieved a response per the criteria defined were included in the duration of the response analysis. Participants lost to follow-up prior to PD or death were censored at the date they were last known to still be responding to treatment. Duration of response was estimated using the Kaplan-Meier method with the median duration of response summarized.|From the date of the first documented CR (confirmed or unconfirmed) or PR until the date of first documentation of recurrent or PD or death, assessed up to 5 years 9 months|EA population|||Months||Standard Deviation|Median
2837959|NCT00211185|Secondary|Overall Response in the Efficacy Analyzable (EA) Population|Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.|From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months|EA population includes all participants who received at least 2 cycles of study drug treatment, were eligible to participate or ineligible with an exception granted by the principal investigator (PI), had bidimensional lesions at baseline, and had at least 1 disease response assessment form submitted following cycle 2.|||Percentage of participants|||Number
2837960|NCT00211185|Secondary|Overall Response in the Intent To Treat (ITT) Population|Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (PR). The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.|From the start of the treatment to the date of participant's death assessed up to 5 years 9 months|Intent to treat (ITT) population included all participants who signed an informed consent and were deemed eligible to participate by the investigator based on the screening assessments, and started at least 1 cycle of study treatment. It is the same as the Safety Population (SP) for this study.|||Percentage of participants|||Number
2838001|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
2837961|NCT00211185|Primary|Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events|A serious adverse event (SAE) was any AE that occurred at any dose and resulted in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that did not result in death, were life-threatening, or required hospitalization were considered a SAE when based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Possibly Related (Poss Rel) applied to AEs judged to be perhaps related to study medication, Probably Related (Prob Rel) applied to AEs judged to have a high degree of certainty as related to study medication, and Definitely Related (Def Rel) related applied to AEs that were judged to be without a doubt related to study medication.|From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months|Safety population|||Participants|||Number
2837962|NCT00211185|Primary|Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class|Treatment-related AEs were medical occurrences determined to be possibly, probably, or definitely related to study treatment. Severity grading of the AE was according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity scale (grades 1 - 5) with grade 3 representing a severe AE. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit.|From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months|Safety population|||Percentage of participants|||Number
2837963|NCT00211185|Primary|Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants|A treatment-related adverse event was any medical occurrence in a participant who was administered denileukin diftitox and CHOP and was determined to be possibly, probably, or definitely related to study treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit.|From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months|Safety population|||Percentage of participants|||Number
2837964|NCT00211185|Primary|Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants|An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit.|From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months|The Safety Population was used and defined as all treated participants. Participants who did not receive at least one dose of study medication were excluded from this population. For this study, the safety population is the same as the Intent to Treat (ITT) population.|||Percentage of participants|||Number
2837965|NCT00211172|Primary|Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date|The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription|9 months||||Adjusted monthly % of days covered||Standard Deviation|Mean
2837966|NCT00211081|Secondary|Change in 6 Minute Walk Test Score||Baseline, Post-Intervention (4 Weeks)|This assessment was not completed during the study.||||||
2837967|NCT00211081|Secondary|Tumor Necrosis Factor-Alpha (TNF-a) Level|The normal result for TNF-a is <5.6 pg/mL.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||pg/mL||Inter-Quartile Range|Median
2837968|NCT00211081|Secondary|Interleukin-10 (IL10) Level|The normal result for IL-10 for Interleukin 10 is < 18pg/ml.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||18pg/ml||Inter-Quartile Range|Median
2837969|NCT00211081|Secondary|Interleukin 1 Beta (IL1b) Level|The normal result for IL1b is <3.9 pg/mL.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||pg/mL||Inter-Quartile Range|Median
2837970|NCT00211081|Secondary|Interleukin-6 (IL-6) Level|The normal result for IL-6 for Interleukin 6 is < 5pg/ml.|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||pg/ml||Inter-Quartile Range|Median
2837971|NCT00211081|Secondary|C-Reactive Protein Level|The normal reference range for C-reactive protein is as follows: CRP: 0-10mg/L|Baseline, Post-Intervention (4 Weeks)|Subjects that completed all study visits.|||mg/L||Inter-Quartile Range|Median
2838002|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
2837973|NCT00210639|Primary|Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase|"The criteria used to assess Musculoskeletal Adverse Event is based on system organ class Musculoskeletal and connective tissue disorders of MedDRA 13.0."|Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)|Participants (207) who were followed up during the MSD Follow-Up Phase.|||Participants|||Number
2837974|NCT00210626|Secondary|Return to Usual Activity (RTUA)|Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.|Hospital Discharge to Post-Hospital Discharge Week 24|Intention to Treat(ITT)population and completed Week 24 Post-Hospital discharge.|||Participants|||Number
2837975|NCT00210626|Primary|SF-36 PF Score|Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.|Hospital Discharge to Post-Hospital Discharge Week 24|ITT (Intent to Treat), The number of subjects analyzed includes all ITT subjects that did not withdraw from the study prior to hospital discharge.|||Units on a scale.||Standard Deviation|Mean
2837976|NCT00210470|Secondary|Correlation of Tumor Response or Immune Competence (Lymphocyte Infiltration) With Disease-Free Survival or Overall Survival|Investigate whether clinical or histological tumor response or improvement in immune competence correlate with DFS and OS|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||2012-09-30|09/2012||||
2837977|NCT00210470|Secondary|Overall Survival|Estimate overall survival (OS) in patients receiving the IRX-2 regimen|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||2012-09-30|09/2012||||
2837978|NCT00210470|Secondary|Disease-free Survival|Estimate disease-free survival (DFS) (defined as time from cyclophosphamide administration and time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy; margins of resection positive for tumor will not be considered disease recurrence)|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||2012-09-30|09/2012||||
2837979|NCT00210470|Secondary|Immune Competence as Measured by Lymphocyte Infiltration|To assess measures of immune competence following administration of the IRX-2 regimen, including total lymphocyte count, peripheral T-cell count and subpopulation studies, and skin test reactivity|At approx. 21 days, prior to surgery||2012-09-30|09/2012||||
2837980|NCT00210470|Secondary|Evaluate Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;||Following surgery and post-operative therapy||2012-09-30|09/2012||||
2837981|NCT00210470|Secondary|Clinical and Histological Tumor Responses||At approx. 21 days, prior to surgery||2012-09-30|09/2012||||
2837982|NCT00210470|Primary|Number of Participants With Adverse Events and Serious Adverse Events|The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described. The number of deaths during study and their relatedness (or not) to treatment, as well as changes in laboratory measures, were published (see referenced publication for details: Wolf, 2011).|Enrollment through 30 days post-surgery|"27 participants were entered into study and treated. All participants were included in the safety analysis.~Based on safety results, the treatment regimen was tolerated. Further clinical study was recommended to evaluate efficacy."|||participants|||Number
2837983|NCT00210353|Secondary|Overall Survival|Percentage of patients alive after 5 years from trial registration|5 years|Evaluable Patients|||percentage of patients||95% Confidence Interval|Number
2837984|NCT00210353|Secondary|Progression-free-survival (PFS)|Percentage of patients without disease progression after 5 years from trial registration|5 years|Evaluable Patients|||percentage of patients||95% Confidence Interval|Number
2837985|NCT00210353|Secondary|Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration|"Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma.~Complete response (CR). Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters)."|5 years|Evaluable patients|||percentage of patients||95% Confidence Interval|Number
2837986|NCT00210353|Secondary|Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment|"Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma.~Complete response. Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters).~Partial response. Decrease by at least 50% in SPD of the six largest measurable lesions. It is not necessary for all lesions to have regressed to qualify for partial response, but no lesion should have progressed and no new lesion should appear.~For primary gastric sites, response was based on GELA histologic grading system."|End of treatment (after 24 weeks of therapy)|Evaluable patients|||percentage of patients||95% Confidence Interval|Number
2837987|NCT00210353|Primary|Event-free-survival (EFS)|Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration|5 years|Evaluable patients|||percentage of patients||95% Confidence Interval|Number
2837988|NCT00209560|Secondary|Time to Fully Alert From the End of the Procedure|Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized.|At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status|The primary analysis for the secondary efficacy endpoint was based on the mITT population. Missing values or incomplete data were not imputed.|||minutes||Standard Deviation|Mean
2837989|NCT00209560|Primary|Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation|"The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined.~Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze"|Sedation success was assessed at 2 minute intervals until the end of the procedure|The pP1 and mITT population included all subjects randomized,received either fospropofol disodium or midazolam, had at least 1 postdose clinical assessment, and were not terminated due to the Investigator’s decision for nonstudy drug related findings. A 95% confidence interval for the sedation success rate was calculated for each treatment group.|||participants||95% Confidence Interval|Number
2837990|NCT00209417|Secondary|Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.|"Overall Image Quality rated as Excellent, Good, Sufficient or Insufficient Poor by radiologists blinded to the contrast administration."|Within 2, 3 and 7 days post contrast administration.||||Number of images|Participants||Number
2837991|NCT00209417|Primary|Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.|"The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).~Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction."|From baseline up to 3 days post contrast administration.|To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group.|||percentage of subjects||95% Confidence Interval|Number
2837992|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|60 months|"NYHA functional class was evaluated in 15 patients at the 48-month follow-up visit. NYHA assessment is missing in 40 patients due to:~30 withdrawals~4 deaths~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2837993|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|48 months|"NYHA functional class was evaluated in 19 patients at the 48-month follow-up visit. NYHA assessment is missing in 36 patients due to:~23 withdrawals~3 deaths~1 missed visit~3 NYHA assessments not done~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2837994|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 months|"NYHA functional class was evaluated in 21 patients at the 36-month follow-up visit. NYHA assessment is missing in 34 patients due to:~19 withdrawals~2 deaths~3 missed visits~4 NYHA assessments not done~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2838003|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
2838004|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min/m^2||95% Confidence Interval|Mean
2839012|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2837995|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|"NYHA functional class was evaluated in 28 patients at the 24-month follow-up visit. NYHA assessment is missing in 27 patients due to:~18 withdrawals~2 deaths~1 missed visit~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2837996|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|18 months|"NYHA functional class was evaluated in 27 patients at the 18-month follow-up visit. NYHA assessment is missing in 28 patients due to:~15 withdrawals~2 deaths~5 missed visits~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2837997|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|"NYHA functional class was evaluated in 39 patients at the 12-month follow-up visit. NYHA assessment is missing in 16 patients due to:~8 withdrawals~1 death~NYHA assessment not done in 1 patient~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2837998|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|"NYHA functional class was evaluated in 47 patients at the 30-day follow-up visit. NYHA assessment is missing in 8 patients due to:~2 withdrawals~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2837999|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|"NYHA functional class was evaluated in 41 patients at the 6-month follow-up visit. NYHA assessment is missing in 14 patients due to:~7 withdrawals~1 death~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."|||participants|||Number
2838000|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline||||participants|||Number
2839013|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2838006|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
2838007|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
2838008|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
2838009|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
2838010|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||L/min||95% Confidence Interval|Mean
2838011|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
2838012|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
2838013|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
2838014|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
2838015|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||mmHg||95% Confidence Interval|Mean
2838016|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838017|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838018|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838019|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT~PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838020|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838021|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2839014|NCT00195715|Secondary|Percentage of Subjects With Nonmelanoma Skin Cancer||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2838022|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838023|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838024|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838025|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||cm^2||95% Confidence Interval|Mean
2838026|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838027|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838028|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838029|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838030|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838031|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838032|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838033|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838034|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838035|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.|||Milliliter||95% Confidence Interval|Mean
2838036|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 6 months||||percentage of participants|||Number
2838037|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 30 days||||percentage of participants|||Number
2838038|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 6 Months||||percentage of participants|||Number
2838039|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 30 days||||percentage of participants|||Number
2838040|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 5 years||||Percentage of participants||95% Confidence Interval|Number
2838041|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 4 years||||Percentage of participants||95% Confidence Interval|Number
2838042|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 3 years||||Percentage of participants||95% Confidence Interval|Number
2838043|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 24 months||||Percentage of participants||95% Confidence Interval|Number
2838044|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 12 months||||Percentage of participants||95% Confidence Interval|Number
2838045|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||Within 30 days of the procedure||||Percentage of participants|||Number
2838046|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 5 Years||||Percentage of participants||95% Confidence Interval|Number
2838047|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 4 Years||||Percentage of participants||95% Confidence Interval|Number
2838048|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 3 Years||||Percentage of participants||95% Confidence Interval|Number
2838049|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 24 months||||Percentage of participants||95% Confidence Interval|Number
2838050|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 12 months||||Percentage of participants||95% Confidence Interval|Number
2838051|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At baseline||||Percentage of participants|||Number
2838052|NCT00209339|Secondary|MitraClip Device Embolizations and Single Leaflet Device Attachment|MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.|Post index procedure through 5 years|Of the 55 patients enrolled in the EVEREST I study, 6 patients did not have a MitraClip device implanted.|||Participants|||Number
2838053|NCT00209339|Secondary|Second Intervention to Place a Second MitraClip Device||Post index procedure through 5 years||||Participants|||Number
2838054|NCT00209339|Secondary|Post-procedure Hospital Stay||Post-index procedure until hospital discharge (1 to 19 days)||||Days||Standard Deviation|Mean
2838055|NCT00209339|Secondary|Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration||Post index procedure within 30 days||||Hours||Standard Deviation|Mean
2838056|NCT00209339|Secondary|Intra-procedural Major Adverse Events|Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure|At day 0 (on the day of index procedure)||||percentage of participants|||Number
2838057|NCT00209339|Secondary|Number of Mitraclip Devices Implanted||At day 0 (on the day of index procedure)||||Percentage of participants|||Number
2838058|NCT00209339|Secondary|Fluoroscopy Duration|Mean fluoroscopy duration during the MitraClip procedure.|At day 0 (on the day of index procedure)|Mean fluoroscopy duration was not recorded in one patient. Therefore, mean fluoroscopy data is available for 54 of the 55 patients.|||Minutes||Standard Deviation|Mean
2838059|NCT00209339|Secondary|Contrast Volume|Mean contrast volume utilized during the MitraClip procedure.|At day 0 (on the day of index procedure)|Contrast volume was not recorded in one patient. Therefore, contrast volume data is available for 54 of the 55 patients.|||Milliliters||Standard Deviation|Mean
2838060|NCT00209339|Secondary|Device Time|Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.|At day 0 (on the day of index procedure)||||Minutes||Standard Deviation|Mean
2839015|NCT00195715|Secondary|Percentage of Subjects With Lymphoma||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2838061|NCT00209339|Secondary|Procedure Time|"Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours.~The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device."|At day 0 (on the day of index procedure)||||Minutes||Standard Deviation|Mean
2838062|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 6 Months||||Percentage of participants|||Number
2838063|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 30 days||||Percentage of participants|||Number
2838064|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 5 years|Of total 55 patients population 15 patients were analysed, as 40 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
2838065|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 4 years|Of total 55 patients population 19 patients were analysed, as for 4 patients Echocardiogram was not performed and 32 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
2838066|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 3 years|Of total 55 patients population 23 patients were analysed, as for 5 patients Echocardiogram was not performed and 27 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
2838067|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 24 months|Of total 55 patients population 28 patients were analysed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
2838068|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 12 months|Of total 55 patients population 39 patients were analyzed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.|||Percentage of participants|||Number
2838069|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At discharge or within 30 days of the procedure|Based on the number of patients who have not died or withdrawn, and have reached the scheduled visit window|||Percentage of participants|||Number
2838070|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At baseline|Of total 55 patients,for 1 patient Echocardiogram was not evaluable.|||Percentage of participants|||Number
2838071|NCT00209274|Secondary|Number of Participants With Incidence of Mitral Valve Replacement||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838072|NCT00209274|Secondary|Number of Participants With Incidence of Mitral Valve Replacement||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838073|NCT00209274|Secondary|Number of Participants With Non-cerebral Thromboembolism.|Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.|30 days|ITT population.|||Participants|||Count of Participants
2838074|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838075|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838076|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838077|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838078|NCT00209274|Secondary|Number of Participants With MR Severity|MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838079|NCT00209274|Secondary|Number of Participants With MR Severity|"MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.~Discharge refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838080|NCT00209274|Secondary|Number of Participants With Non-cerebral Thromboembolism.|Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.|12 months|ITT population.|||Participants|||Count of Participants
2838081|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 5 years|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
2838082|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 4 years|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
2838083|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device|12 months to 3 years|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
2838084|NCT00209274|Secondary|Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment|Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.|12 months|The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
2838085|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838086|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838087|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838088|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838089|NCT00209274|Secondary|Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838090|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838091|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838092|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838093|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838094|NCT00209274|Secondary|Number of Participants With Freedom From Mitral Valve Surgery/Re-operation|Durability estimates: Freedom from Mitral Valve Surgery/Re-operation|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838095|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838096|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838097|NCT00209274|Secondary|Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+|Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838098|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|24 months-3 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838099|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|18-24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838100|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|12-18 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838101|NCT00209274|Secondary|Number of Participants With Durability of the MitraClip Device and Surgery.|"Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.~Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838102|NCT00209274|Secondary|Number of Participants With New Coumadin (Warfarin) Usage||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838103|NCT00209274|Secondary|Number of Participants With New Coumadin (Warfarin) Usage||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838104|NCT00209274|Secondary|Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838105|NCT00209274|Secondary|Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838106|NCT00209274|Secondary|Number of Participants With Hospital Re-admissions|Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838107|NCT00209274|Secondary|Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||hours||Standard Deviation|Mean
2838108|NCT00209274|Secondary|Post-procedure Length of Hospital Stay||30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||days||Standard Deviation|Mean
2838109|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2838110|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|4 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2838111|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|3 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2838112|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2838113|NCT00209274|Secondary|Transvalvular Mitral Mean Pressure Gradient (Mean MVG)|Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2838114|NCT00209274|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.|At Discharge (≤ 14 days following index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2839016|NCT00195715|Secondary|Percentage of Subjects With Malignancy||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2838115|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2838116|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2838117|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2838118|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838119|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838120|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838121|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838122|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838123|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838124|NCT00209274|Secondary|Mitral Valve Area by Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|At Discharge (≤14 days of index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838125|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2838126|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2838127|NCT00209274|Secondary|Mitral Valve Area by Planimetry Index|Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2838128|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838129|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838130|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838131|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838132|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838133|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838134|NCT00209274|Secondary|Mitral Valve Area by Planimetry|Mitral valve area as measured by core lab echocardiography.|At Discharge (≤14 days of index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2838135|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|"Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A confirmed case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A conservative case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms."|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838136|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|"Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A confirmed case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A conservative case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838766|NCT00197392|Secondary|Hospital Locations for EVD Catheter Placement|Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).|Implantation of subject||||Participants|||Number
2838137|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|"Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A confirmed case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A conservative case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838138|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838139|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|12 months|ITT population.|||Participants|||Count of Participants
2838140|NCT00209274|Secondary|Number of Participants With Mitral Valve Stenosis|Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.|30 days|ITT population.|||Participants|||Count of Participants
2838141|NCT00209274|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|12 months|ITT population.|||Participants|||Count of Participants
2838142|NCT00209274|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD).|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|30 days|ITT population.|||Participants|||Count of Participants
2838143|NCT00209274|Secondary|Number of Participants With Hemolysis|"Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:~Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.~Minor: Does not require intervention."|12 months|ITT population.|||Participants|||Count of Participants
2838144|NCT00209274|Secondary|Number of Participants With Hemolysis|"Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:~Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.~Minor: Does not require intervention."|30 days|ITT population.|||Participants|||Count of Participants
2838145|NCT00209274|Secondary|Number of Participants With Thrombosis.|Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.|12 months|ITT population.|||Participants|||Count of Participants
2838146|NCT00209274|Secondary|Number of Participants With Thrombosis.|Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.|30 days|ITT population.|||Participants|||Count of Participants
2838147|NCT00209274|Secondary|Number of Participants With Endocarditis.|Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.|12 months|ITT population.|||Participants|||Count of Participants
2838148|NCT00209274|Secondary|Number of Participants With Endocarditis.|Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.|30 days|ITT population.|||Participants|||Count of Participants
2838149|NCT00209274|Secondary|Number of Participants With Dysrhythmia||12 months|ITT population.|||Participants|||Count of Participants
2838150|NCT00209274|Secondary|Number of Participants With Dysrhythmia||30 days|ITT population.|||Participants|||Count of Participants
2838151|NCT00209274|Secondary|Number of Participants With MAE in Patients Over 75 Years of Age.||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838152|NCT00209274|Secondary|Number of Participants With MAE in Patients Over 75 Years of Age.||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838153|NCT00209274|Secondary|Number of Participants With Major Adverse Events (MAE)||12 months.|Intent to treat (ITT) population.|||Participants|||Count of Participants
2838154|NCT00209274|Secondary|Number of Participants With Major Bleeding Complications.|Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.|12 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838155|NCT00209274|Secondary|Number of Participants With Major Bleeding Complications.|Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838767|NCT00197392|Secondary|Time Point of Introduction of Systemic Antibiotic Therapy|Time points of then patients received systemic antibiotic therapy|Within 48 hours of implant of subjects to explant||||Paticipants|||Number
2838156|NCT00209274|Secondary|Number of Participants With Major Vascular Complications|"Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arteriovenous (AV) fistula;~Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;~Vascular Surgical Repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838157|NCT00209274|Secondary|Number of Participants With Major Vascular Complications|"Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arteriovenous (AV) fistula;~Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;~Vascular Surgical Repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838158|NCT00209274|Secondary|Number of Participants With MAE: Surgery After Device and First Time Surgery Control||30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838159|NCT00209274|Secondary|Number of Participants With Procedural Freedom From In-hospital MAE||Day 30|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838160|NCT00209274|Secondary|Number of Participants With Procedural Freedom From In-hospital MAE.||Day 0|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838161|NCT00209274|Secondary|Number of Participants With Mitral Valve Repair Success.|Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838162|NCT00209274|Secondary|Number of Participants With Mitral Valve Repair Success.|Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838163|NCT00209274|Secondary|Number of Participants With Successful Clip Implant and Acute Procedural Success|Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.|30 days|The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
2838164|NCT00209274|Secondary|Number of Participants With Acute Surgical Success|Defined as successful mitral valve repair or replacement surgery.|30 Days|The number of participants analyzed in control group includes subjects who had available follow up data at that time frame. Not applicable for Device group patients as device was not implanted. The population includes all patients who underwent the index surgical procedure and excludes 15 patients who were randomized, but not treated.|||Participants|||Count of Participants
2838165|NCT00209274|Secondary|Number of Participants With Acute Procedural Success|Defined as successful MitraClip implantation with resulting MR of 2+ or less.|30 Days|ITT population. The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.|||Participants|||Count of Participants
2838166|NCT00209274|Secondary|Number of Participants With Clip Implant Rate|Defined as the rate of successful implantation of MitraClip(s).|Day 0|The number of participants analyzed includes subjects who had available follow up data at that time frame. MitraClip was not implanted in control group, hence overall number of patients analyzed will remain 0.|||Participants|||Count of Participants
2838167|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of LV stroke volume||Standard Deviation|Mean
2838168|NCT00209274|Secondary|Regurgitant Fraction|Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of LV stroke volume||Standard Deviation|Mean
2838169|NCT00209274|Secondary|Regurgitant Fraction (RF)|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of LV stroke volume||Standard Deviation|Mean
2838170|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2838171|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2838172|NCT00209274|Secondary|Regurgitant Volume|Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|30 Days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2838173|NCT00209274|Secondary|Cardiac Index|Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2838174|NCT00209274|Secondary|Cardiac Index (CI)|Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2838175|NCT00209274|Secondary|Cardiac Index|Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2838176|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2838177|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2838178|NCT00209274|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2838179|NCT00209274|Secondary|Short Form (SF)-36 Quality of Life Questionnaire.|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||scores on a scale||Standard Deviation|Mean
2838180|NCT00209274|Secondary|Short Form (SF)-36 Quality of Life Questionnaire.|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|"The SF-36 questionnaire consists of 36 questions in relation to eight health concepts:~Physical functioning, role limitations due to physical health, bodily pain,general health perceptions,vitality (energy/fatigue),social functioning,role limitations due to emotional health and general mental health (psychological distress/wellbeing)."|||scores on a scale||Standard Deviation|Mean
2838181|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838182|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838183|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838768|NCT00197392|Secondary|Non-infectious Catheter Failure in the MITT Population|Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.|Implant of subject to explant||||Participants|||Number
2838184|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838185|NCT00209274|Secondary|Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838186|NCT00209274|Secondary|New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838187|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838188|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838189|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838190|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2839769|NCT00185640|Secondary|Event-free Survival (EFS)|Reports the proportion of subjects who neither died due to any cause nor experienced relapse.|3 and 5 years||||percentage of participants|||Number
2838191|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838192|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838193|NCT00209274|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline|ITT population.|||Participants|||Count of Participants
2838194|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838195|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838196|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838197|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838198|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838199|NCT00209274|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838200|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838201|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838202|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838203|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838204|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838205|NCT00209274|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2838206|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2838207|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2838208|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2838209|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2838210|NCT00209274|Secondary|Left Ventricular Status- LVEDV, LVESV|Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2838211|NCT00209274|Secondary|Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)|Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2838212|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
2838213|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
2838214|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
2838215|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
2838216|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
2838217|NCT00209274|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.|At discharge (≤ 14 days following index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of volume ejected||Standard Deviation|Mean
2838218|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2838219|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).||24 months|Per-protocol population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838220|NCT00209274|Secondary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.||12 months|Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838221|NCT00209274|Secondary|Freedom From All-Cause Mortality||5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838222|NCT00209274|Secondary|Freedom From All-Cause Mortality||4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838223|NCT00209274|Secondary|Freedom From All-Cause Mortality||3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838224|NCT00209274|Secondary|Freedom From All-Cause Mortality||24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838225|NCT00209274|Secondary|Freedom From All-Cause Mortality||12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of participants|||Number
2838226|NCT00209274|Primary|Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).||12 months|Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838227|NCT00209274|Primary|Number of Participants With Major Adverse Events (MAE)|Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2838769|NCT00197392|Secondary|Diagnosis Requiring EVD Implantation|Primary diagnosis for implantation of EVD system|Implantation of EVD system|Analysis consisted of combining both Arm/Group (Bactiseal and Standard)|||Participants|||Number
2838228|NCT00209170|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24|"The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, week 24|Last Observation Carried Forward|||participants|||Number
2838229|NCT00209131|Secondary|Medical Evaluation|Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.|2 weeks and 3 months|||||||
2838230|NCT00209131|Primary|Time to Passage of Stone Fragments|Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.|2 weeks and 3 months|No analysis was conducted.||||||
2838231|NCT00209092|Secondary|Long Term Follow up Data on Recurrence and Survival|Number of Patients remained alive and relapse free|2 years||||participants|||Number
2838232|NCT00209092|Primary|Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.~Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)~Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.~Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site."|1 year||||participants|||Number
2838233|NCT00209027|Primary|BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task|fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.|Baseline and 12 weeks|Prespecified data not collected because the study was terminated before subjects received aripiprazole.||||||
2838234|NCT00208975|Primary|Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab.|"Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor.~Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period.~Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed"|6 months||||participants|||Number
2838235|NCT00208949|Secondary|Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.|Median overall survival|5 years||||months||Full Range|Median
2838236|NCT00208949|Primary|Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft||at transplant (1 day)|Sample size determinations for this randomized trial were based on a baseline frequency of mDCs(myeloid dendritic cells) and pDCs( plasmacytoid dendritic cells)within the peripheral blood of 0.5% with a SD equal to the mean (0.5%).|||x10 ^ 6 cells/kg||Standard Error|Median
2838237|NCT00208767|Primary|Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years|The PI will measure carotid artery thickening with magnetic resonance imaging.|Baseline, 2 years||||mm2||Standard Deviation|Mean
2838238|NCT00208507|Secondary|Complication Rates||On-going to end of study|||||||
2838239|NCT00208507|Primary|Harris Hip Total Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.|6 weeks, 6, 12 months and last follow up at 24 months or greater||||Units on a scale||Standard Deviation|Mean
2838240|NCT00208494|Primary|Composite Success/Failure|The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.|At 24 months|Out of the 390 subjects, 84 subjects were removed from the analysis for the following reasons: 2 deaths (1 in each arm); 3 protocol violations (2 COM, 1 MOM); 28 bilateral (12 COM, 16 MOM); 39 subjects had no 24-month Harris Hip score (22 COM, 17 MOM); and 12 subjects had no 24-month x-ray (4 COM, 8 MOM).|||Participants|||Number
2838241|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 62 subjects in the PFC Sigma Fixed Bearing and 60 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838660|NCT00201240|Secondary|Graft Failure|Primary graft failure is defined as the failure to achieve an ANC > 500 cells/µL by Day +30. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in neutrophil counts < 500 cells/µL, unresponsive to growth factor therapy.|Day 100||||participants|||Number
2838242|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 60 subjects in the PFC Sigma Fixed Bearing and 62 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838243|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 77 subjects in the PFC Sigma Fixed Bearing and 70 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838244|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 75 subjects in the PFC Sigma Fixed Bearing and 71 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838245|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838246|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838247|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838248|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838249|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838250|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838770|NCT00197392|Secondary|Average Subject Age|The average subject age|Implant to subject||||Years||Standard Deviation|Mean
2838251|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838252|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838253|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants||95% Confidence Interval|Number
2838254|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants||95% Confidence Interval|Number
2838255|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants||95% Confidence Interval|Number
2838256|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838257|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838258|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838259|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838661|NCT00201240|Secondary|Platelet Engraftment|Time to platelet engraftment is measured by determining the first of three consecutive measurements of platelet count ≥ 20,000/uL without platelet transfusion support for seven days, starting from Day 0.|6 Months||||days||Full Range|Median
2838260|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838261|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 122 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838262|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 153 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838263|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 141 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838264|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838265|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838266|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838294|NCT00208091|Primary|Note Errors (Related to Errors in Duration)|Note errors (related to errors in duration in msec) were obtained as measures of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note output from four musical sequences of 8 to 16 notes played. It was calculated by averaging the sequences for each hand, and deriving the square root of the mean of the square of the differences (root mean square error, in msec) in MIDI.|Baseline and 6 weeks post-injection||||msec||Standard Error|Median
2838267|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838268|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838269|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838270|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838271|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838272|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838273|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838274|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838376|NCT00206076|Primary|Number of Biopsy Proven Rejections at 12 Months|assessed by liver biopsy using Banff International Consensus Schema|12 months||||participants|||Number
2838275|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||percentage of participants|||Number
2838276|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 124 subjects in the PFC Sigma Fixed Bearing and 125 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838277|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 146 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838278|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 155 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838279|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 120 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838280|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838281|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838282|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 114 subjects in the PFC Sigma Fixed Bearing and 111 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838283|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 134 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838377|NCT00205881|Secondary|HINT Sentences in Noise|20 sentences presented in noise at fixed levels|8 months of bilateral cochlear implant use|||||||
2838771|NCT00197392|Secondary|Number of Days With Indwelling Catheter|Days catheter was implanted in subjects|Implant of subjects to day of explant||||Days||Standard Deviation|Mean
2838284|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 145 subjects in the PFC Sigma Fixed Bearing and 138 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
2838285|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 123 subjects in the PFC Sigma Fixed Bearing and 124 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838286|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838287|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 156 subjects in the PFC Sigma Fixed Bearing and 148 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838288|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 153 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838289|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 164 subjects in the PFC Sigma Fixed Bearing and 164 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838290|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 155 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838291|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 168 subjects in the PFC Sigma Fixed Bearing and 167 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.|||degrees||Standard Deviation|Mean
2838292|NCT00208091|Secondary|Subjective Assessment Ratings of Change|Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).|Baseline to 6 weeks after injection||||percentage change||Standard Deviation|Mean
2838293|NCT00208091|Primary|Note Errors (Related to Errors in Loudness)|Note errors (related to errors in loudness) were obtained as a measure of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note loudness data (decibels) from four musical sequences of 8 to 16 notes. It was calculated by averaging sequences for each hand and taking the square root of the mean of the square of the differences (root mean square error, in decibels) in MIDI notes.|Baseline and 6 weeks post-injection||||decibels||Standard Error|Median
2838662|NCT00201240|Secondary|Neutrophil Engraftment|Time to neutrophil engraftment is measured by determining the first of three consecutive measurements of absolute neutrophil count ≥ 500/uL following conditioning regimen induced nadir, starting from Day 0.|28 day||||days||Full Range|Median
2838295|NCT00208026|Primary|Blood Pimecrolimus Levels|At each scheduled visit, blood concentration of pimecrolimus were obtained. This value reflects the amount of pimecrolimus in the blood. This is measured directly from the blood and provides an estimate of the degree of absorption of the treatment medication through the skin into the blood.|Each visit up to 18 months: Study Days 1, 7, 14, 28, 56, 84, 175, 360, and 520||||ng/mL|||Number
2838296|NCT00207883|Secondary|Time to Successful Central Line Placement|Time, in seconds, till successful guide wire placement was achieved.|immediate|Critically ill children requiring central venous access.|||seconds||Inter-Quartile Range|Median
2838297|NCT00207883|Primary|Central Line Placement Success|Success was defined as central venous catheter being able to thread into the vessel over the guide wire.|immediate|Population consisted of critically ill children requiring placement of a central venous catheter.|||participants|||Number
2838298|NCT00207740|Secondary|Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects|The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR— Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward (LOCF).|||L/min||Standard Deviation|Mean
2838299|NCT00207740|Secondary|Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline|The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.|Baseline and Week 52|Analysis of this endpoint includes only pts who received OCS at baseline.Wk 52 OCS dose is the daily OCS dose in the last period, defined as between 2 consecutive visits, in which no change in total daily dose of OCS occurred, prior to Wk 52 visit.Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various timepoints.|||mg/day P. Eq.||Inter-Quartile Range|Median
2838300|NCT00207740|Secondary|Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24|The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24|Week 24 to Week 52|Analysis of this endpoint only includes patients (pts) who did not discontinue study participation prior to Wk 24. For the dropouts during the period between Wks 24- 52, worst case in similar pts was used as the number of severe exacerbations. Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various study timepoints|||Events per patient from Wk 24 thru Wk 52||Standard Deviation|Mean
2838301|NCT00207740|Secondary|Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients|The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.|||Puffs/day||Inter-Quartile Range|Median
2838302|NCT00207740|Primary|Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months|The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. For the dropouts, the worst case in similar patients was used as the number of severe exacerbations.|||Events per patient through week (Wk) 24||Standard Deviation|Mean
2838303|NCT00207740|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients|The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.|||Points on scale||Inter-Quartile Range|Median
2838304|NCT00207740|Primary|Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second|The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.|Baseline and Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using Last Observation Carried Forward (LOCF).|||Percent predicted||95% Confidence Interval|Least Squares Mean
2838305|NCT00207727|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|The EDSS is based on an independent neurologist's examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.|Baseline, Week 23|Intent to treat. Missing data was imputed. Missing EDSS scores was replaced with the last non-missing EDSS value observed (last observation carried forward).|||Units on a scale||Inter-Quartile Range|Median
2838306|NCT00207727|Secondary|Relapses of Multiple Sclerosis (MS) Through Week 23|Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.|Week 23|Missing data remained missing. No treatment failure rule was implemented.|||Relapses||Inter-Quartile Range|Median
2838307|NCT00207727|Primary|The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.|A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.|Week 23|Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated.|||Lesions||Inter-Quartile Range|Median
2839770|NCT00185640|Secondary|Overall Survival (OS)||3 and 5 years||||percentage of participants|||Number
2838308|NCT00207714|Secondary|Summary of ACR-N, Index of Improvement at Week 16|The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.|Week 16|Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied.|||Scores on scale||Inter-Quartile Range|Median
2838309|NCT00207714|Primary|Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 16|Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.|||Participants|||Number
2838310|NCT00207142|Secondary|Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase|Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.|Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase). Analysis used last observation carried forward (LOCF) to replace missing values.|||percent change||95% Confidence Interval|Mean
2838311|NCT00207142|Secondary|Summary of Adverse Events During Rescue Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.|Participants who received at least 1 dose of Rescue Phase study therapy|||Participants|||Number
2838312|NCT00207142|Secondary|Summary of Adverse Events During Maintenance Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase).|||Participants|||Number
2838313|NCT00207142|Secondary|Summary of Adverse Events During Induction Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).|Participants who received at least 1 dose of Induction Phase study therapy.|||Participants|||Number
2838314|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase|Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 30-32||||Participants|||Number
2838315|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase|Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 38-40, Week 64-66||||Participants|||Number
2838316|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.|Baseline, Week 48 of Rescue Phase||||Participants|||Number
2838317|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.|Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.||||Participants|||Number
2838318|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.|\Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 48 of Rescue Phase)|||log10 c/mL||Standard Error|Mean
2838319|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 24 of Induction Phase).|||log10 c/mL||Standard Error|Mean
2838320|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase|Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and Week 48 of Rescue Phase).|||cells/mm3||Standard Error|Mean
2838321|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase|Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and at the end of Induction Phase).|||cells/mm3||Standard Error|Mean
2838322|NCT00207142|Secondary|Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase|Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.|End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization). Analysis uses observed values (participants included are those with CD4 measurements at end of Induction Phase and at Week 48 of Maintenance Phase).|||cells/mm3||Standard Error|Mean
2838323|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)|||Proportion of participants|||Number
2838324|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).|||Proportion of participants|||Number
2838325|NCT00207142|Secondary|Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)|||Percentage of participants|||Number
2838326|NCT00207142|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).|||Percentage of participants|||Number
2838327|NCT00207090|Secondary|Number of Participants With Identified ECG Abnormalities|Triplicate 12-lead serial ECGs were performed pre-dose (just prior to infusion), 1.5, 3 (just prior to end of the infusion even if infusion lasted for less than or more than planned 3 hrs), 4, 6, 8 and 24 hrs after start of ixabepilone infusion. Triplicate 12-lead serial ECGs were also to be performed on the date prior to dosing at times approximating post-dose schedule (pre-dose triplicate set of ECGs also qualified as the 24-hr baseline ECGs). Normal ranges for ECG are as follows: heart rate: 40 - 125 bpm; PR: 0.1 - 0.2 msec; QRS: 0.06 - 0.12 msec; QTC: 0.3 - 0.45 msec; QT: 0.3 - 0.5 msec.|Data collected at screening, Day -1 and Day 1 (at 0, 1.5, 3, 4, 6, 8 and 24 hours) after start of infusion.|All participants treated with ixabepilone.|||Participants|||Number
2838328|NCT00207090|Secondary|QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial electrocardiograms (ECGs) that were performed at selected times after the first dose of ixabepilone without rifampin and at matched times prior to the first dose of ixabepilone. Abnormalities occurring at any time during the study were recorded.|Data collected at 0, 1.5, 3, 4, 6, 8 and 24 hours after start of infusion.|All participants treated with ixabepilone. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||millisecond||90% Confidence Interval|Mean
2838378|NCT00205881|Primary|Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.|Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.|8 months of bilateral cochlear implant use|Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation.|||percent of words correct||Standard Deviation|Mean
2838329|NCT00207090|Secondary|Number of Participants With Abnormal Physical Examination Findings|"Physical examination included height (screening only),weight,BSA,Eastern Cooperative Oncology Group Performance Status (ECOG PS),tendon reflexes,sensory function,motor strength. ECOG PS used to assess disease severity:score of 0 is fully active;1 is restricted physically strenuous activity;2 is ambulatory but unable to work;3 is capable of only limited self care;4 is completely disabled;5 is dead. Normal ranges:height:137-200cm or 54-79 inches;weight:40-135kg or 88-298 pounds (lbs);ECOG Scale:0-4. Abnormalities displayed here are those considered clinically significant by the investigator."|From screening to the off treatment visit.|All treated participants.|||participants|||Number
2838330|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Ratio||Standard Deviation|Median
2838331|NCT00207090|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|"Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. Normal ranges for the above are as follows: heart rate: 40 - 125 beats per minute (bpm); systolic BP: 65 - 200 millimeters of mercury (mmHg); diastolic BP: 40 - 120 mmHg; respiratory rate: 10 - 25 breaths per minute; temperature: 95 - 105F or 35 - 40.5C. The abnormalities displayed here are those considered clinically significant by the investigator and include abnormalities recorded at any time during study."|From screening to the off treatment visit.|All treated participants.|||participants|||Number
2838332|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.|All treated participants who were evaluable for PK analysis.|||Ratio||Standard Deviation|Mean
2838333|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])|AUC (0-T) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||nanogram (ng)*hr/mL||Standard Deviation|Mean
2838334|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.|Abnormalities occurring at any time during the study were graded per NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows:Calcium: Grade 3: 6-<7 or >12.5-13.5mg/dL, Grade 4:<6 or >13.5mg/dL. Magnesium: Grade 3:0.6-<0.8 or >2.46-6.6mEq/L, Grade 4:<0.6 or >6.6mEq/L. Potassium: Grade 3:2.5-<3 or >6-7mmol/L, Grade 4:<2.5 or >7.0 mmol/L. Sodium: Grade 3:120-<130 or >155-160 mEq/L, Grade 4:<120 or >160mEq/L. Glucose: Grade 3:30-<40 or >250-500mg/dL, Grade 4:<30 or >500mg/dL. Uric acid: Grade 3:>ULN-10mg/dL with physiologic consequences, Grade 4:>10mg/dL.|Screening, Days 2 and 22.|All treated participants.|||Participants|||Number
2838335|NCT00207090|Primary|Time to Reach Maximum Observed Concentration (T Max)|T max was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Hrs||Full Range|Median
2838336|NCT00207090|Primary|Volume of Distribution at Steady-state (Vss)|Vss was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||L||Standard Deviation|Mean
2838337|NCT00207090|Primary|Total Body Clearance (CLT)|CLT was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Litres(L)/hr||Standard Deviation|Mean
2838338|NCT00207090|Primary|Mean Residence Time Adjusted for Infusion Time (MRT [INF])|(MRT [INF]) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Hrs||Standard Deviation|Mean
2838339|NCT00207090|Primary|Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)|T half was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||Hrs||Standard Deviation|Mean
2838340|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous|Abnormalities occurring at any time during the study were graded per the NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows: Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN. Bilirubin: Grade 3: >3-10 x ULN, Grade 4: >10 x ULN. Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC). Creatinine: Grade 3: >3-6 x ULN, Grade 4: >6 x ULN. Phosphorous: Grade 3: 1-<2mg/dL, Grade 4: <1mg/dL.|Screening, Days 1 and 22.|All treated participants.|||participants|||Number
2838663|NCT00201240|Secondary|Leukemia Relapse|To assess the incidence of acute leukemia relapse from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval. Death prior to relapse will be considered as a competing risk.|Months 12 and 36||||percentage of participants||95% Confidence Interval|Number
2838341|NCT00207090|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities occurring at any time during the study were graded per NCI CTC, v3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are given below. Neutrophils: Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Leukocytes: Grade 3: 1.0 - <2.0x10^9/L, Grade 4: <1.0x10^9/L. Neutrophils + bands (absolute): Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Lymphocytes: Grade 3: 0.2 - <0.5x10^9/L, Grade 4: <0.2x10^9/L. Platelets: Grade 3: 25.0 - <50.0x10^9/L, Grade 4: <25.0x10.|Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.|All treated participants.|||participants|||Number
2838342|NCT00207090|Secondary|Number of Participants Who Died and Who Experienced Other Serious AEs (SAEs), Grade 3-4 AEs, Drug-related AEs and AEs Leading to Study Drug Discontinuation|AEs:new untoward medical occurrences/worsening of pre-existing medical condition,whether or not related to study drug.SAE:AE resulting in death;life threatening;resulted in persistent/significant disability/incapacity;resulted in/prolonged existing hospitalization;a congenital anomaly/birth defect;overdose.Drug-related AEs: relationship to drug of certain;probable;possible;or missing.Participants who discontinued study due to AE were also recorded.AEs graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC),v3:Grade 1=mild,2=moderate, 3=severe,4=life threatening,5=death.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.|||participants|||Number
2838343|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])|AUC (INF) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.|||nanogram (ng)*hour(hr)/mL||90% Confidence Interval|Geometric Mean
2838344|NCT00207090|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|Of the 15 patients in each group, only those with evaluable pharmacokinetic (PK) results are presented.|||nanogram (ng)/millilter(mL)||90% Confidence Interval|Geometric Mean
2838345|NCT00206726|Secondary|Number of Participants With Minimal Residual Disease (MRD)|Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.|When CR is confirmed|All participants for whom CR was confirmed|||participants|||Number
2838346|NCT00206726|Secondary|Percentage of Participants With Overall Response at Different Observation Times|Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier|Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR|||percentage of participants in response|||Number
2838347|NCT00206726|Secondary|Progression-free Survival (PFS)|Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population.|||percentage alive without progression|||Number
2838348|NCT00206726|Secondary|Overall Survival (OS)|Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|Safety Population (all subjects treated)|||Percentage of participants alive|||Number
2838349|NCT00206726|Secondary|Overall Response (OR)|Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|28 days after last cycle with confirmation 2 months later|ITT Population (all subjects enrolled and registered).|||Percentage of participants with CR or PR|||Number
2838350|NCT00206726|Primary|Complete Response (CR)|Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.|28 days after last cycle with confirmation 2 months later|ITT population (all enrolled and registered subjects).|||Percentage of participants with CR|||Number
2838351|NCT00206518|Secondary|Overall Survival||10 years||||participants|||Number
2838352|NCT00206518|Secondary|Disease Relapse|Data associated with relapse and progression will be obtained over the course of 10 years. Relapse/progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|10 years||||participants|||Number
2838379|NCT00205855|Primary|Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.|"The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS."|2 weeks post initial fitting||||participants with > 50% VAS improvement|||Number
2838353|NCT00206518|Primary|Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)|"The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as:~Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR)~Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR)~Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively > 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively < 25% therapeutic effect OR Grade 4~No or few modification of tumoral appearance (pNR)."|10 years||||participants|||Number
2838354|NCT00206440|Primary|Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication|Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy. Thus, we will look at esomeprazole when used to decrease the incidence,severity and duration of nausea/vomiting/retching in breast cancer patients who are receiving anthracycline-based chemotherapy.|2-7 days following chemotheraphy||||Proportion of patients who exhibit no mo|||Number
2838355|NCT00206427|Primary|Clinical Response|Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).|at the end of week 6.|All patients finished 6-week therapy were included. Two patients dropped off therapy early were excluded.|||participants|||Number
2838356|NCT00206427|Secondary|If GW572016 Inhibits HER1 and HER2 Signaling in Situ.||5 years|||||||
2838357|NCT00206336|Primary|Change in TTS|A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).|baseline to Day 70||||units on a scale||Standard Deviation|Mean
2838358|NCT00206323|Primary|Change From Baseline in Total Tic Score at Day 70|"A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint.~The Total Tic Score (TTS) is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)."|baseline and Day 70||||units on a scale||Standard Deviation|Mean
2838359|NCT00206102|Secondary|Number of Participants With Potential Extrapyramidal Symptoms (EPS)|Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor|From start of the study treatment to last dose plus 30 days|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||Participants|||Number
2838360|NCT00206102|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||units on scale||Standard Deviation|Mean
2838361|NCT00206102|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||units of scale||Standard Deviation|Mean
2838362|NCT00206102|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication|||units on scale||Standard Deviation|Mean
2838363|NCT00206102|Secondary|Number of Relapses of Schizophrenia or Schizoaffective Disorder|Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects.|At Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||Relapses|||Number
2838364|NCT00206102|Secondary|Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score|PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838461|NCT00205699|Secondary|Change in Insulin-stimulated Glycerol Rate of Appearance (Glycerol Ra)|This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at adipose tissue, as measured by the insulin-stimulated rate of disappearance of glycerol (glycerol Ra), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||percentage of % change||Standard Deviation|Mean
2838365|NCT00206102|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score|Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838366|NCT00206102|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization.|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838367|NCT00206102|Secondary|Change in the PANSS Psychopathology Subscale Score|"PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= absent psychosis symptom, 7= extreme symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838368|NCT00206102|Secondary|Change in the PANSS Negative Subscale Score|"PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838369|NCT00206102|Secondary|Change in the PANSS Positive Subscale Score|"PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838370|NCT00206102|Secondary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score|"PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.|||units on scale||Standard Deviation|Mean
2838371|NCT00206102|Primary|Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.|||Participants with P type event|||Number
2838372|NCT00206102|Primary|Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.|||Participants with N type event|||Number
2838373|NCT00206102|Primary|Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale|Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.|||Participants with C type event|||Number
2838374|NCT00206076|Secondary|Number of Participants With Adverse Events Including Infections at 12 Months||12 months|everyone enrolled who completed the study|||participants|||Number
2838375|NCT00206076|Secondary|Patient and Graft Survival at 12 Months||12 months|everyone enrolled who completed the study|||participants|||Number
2838380|NCT00205803|Secondary|Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the Toddler Dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
2838381|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the toddler dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
2838382|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
2838383|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||EU/mL||95% Confidence Interval|Geometric Mean
2838384|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.|||titer||95% Confidence Interval|Geometric Mean
2838385|NCT00205803|Secondary|Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||IU/mL||95% Confidence Interval|Geometric Mean
2838386|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||milli International Units (mIU)/mL||95% Confidence Interval|Geometric Mean
2838387|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.|||μg/mL||95% Confidence Interval|Geometric Mean
2838388|NCT00205803|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.|One month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.|||Percentage of participants||95% Confidence Interval|Number
2838419|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mm^2||Standard Error|Least Squares Mean
2838389|NCT00205803|Secondary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)|All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2838390|NCT00205803|Secondary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype.|||μg/mL||95% Confidence Interval|Geometric Mean
2838391|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|One month after the toddler dose (at 13 to 16 months of age)|The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2838392|NCT00205803|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.|||percentage of participants||95% Confidence Interval|Number
2838393|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.|||percentage of participants|||Number
2838394|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.|||percentage of participants|||Number
2838395|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
2838396|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
2838397|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||mm||Standard Error|Least Squares Mean
2838398|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||millimeter (mm)||Standard Deviation|Mean
2838399|NCT00205777|Secondary|Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Error|Least Squares Mean
2838400|NCT00205777|Secondary|European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
2838401|NCT00205777|Secondary|Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Error|Least Squares Mean
2838402|NCT00205777|Secondary|Women's Health Questionnaire (WHQ)|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.|||Units on a scale||Standard Deviation|Mean
2838438|NCT00205777|Secondary|Change From Baseline in Height at Month 60|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.|||mm||Standard Error|Least Squares Mean
2838403|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
2838404|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
2838405|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||ratio/mm||Standard Error|Least Squares Mean
2838406|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||ratio/millimeter (ratio/mm)||Standard Error|Least Squares Mean
2838407|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mcm/d||Standard Error|Least Squares Mean
2838408|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mcm/days (mcm/d)||Standard Error|Least Squares Mean
2838409|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||days||Standard Error|Least Squares Mean
2838410|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||days||Standard Error|Least Squares Mean
2838439|NCT00205777|Secondary|Change From Baseline in Height at Month 36|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.|||millimeter (mm)||Standard Error|Least Squares Mean
2838411|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||Activation of bone formation/year||Standard Error|Least Squares Mean
2838412|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||Activation of bone formation/year||Standard Error|Least Squares Mean
2838413|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
2838414|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
2838415|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
2838416|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
2838417|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||yrs||Standard Error|Least Squares Mean
2838418|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||years (yrs)||Standard Error|Least Squares Mean
2839198|NCT00194675|Secondary|Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.||Baseline, 3-months, 6-months|per protocol|||ng/ dL||Standard Deviation|Mean
2838420|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||Square millimeter (mm^2)||Standard Error|Least Squares Mean
2838421|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TSG|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||mm||Standard Error|Least Squares Mean
2838422|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.|||millimeter (mm)||Standard Error|Least Squares Mean
2838423|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||mcm||Standard Error|Least Squares Mean
2838424|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||micrometer (mcm)||Standard Error|Least Squares Mean
2838425|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||Percentage of indices||Standard Error|Least Squares Mean
2838426|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.|||Percentage of indices||Standard Error|Least Squares Mean
2838712|NCT00200161|Primary|12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.||until death or date of last follow up, an average of 12 months||||percentage of participants|||Number
2838427|NCT00205777|Secondary|Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36|Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).|Baseline, Months 6, 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
2838428|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Percent change||Inter-Quartile Range|Median
2838429|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
2838430|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
2838431|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 72 and 84|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Percent change||Inter-Quartile Range|Median
2838432|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 36 and 60|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
2838433|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||Percent change||Inter-Quartile Range|Median
2838434|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 72, 84|Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.|||Percent change||Standard Deviation|Mean
2838435|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 48, 60|mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percent change||Standard Error|Least Squares Mean
2838436|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Months 6, 12, 18, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percent change||Standard Error|Least Squares Mean
2838437|NCT00205777|Secondary|Change From Baseline in Height at Month 84|Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||mm||Standard Deviation|Mean
2839199|NCT00194675|Secondary|Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume||Baseline, 3-months, 6-months||||cc||Standard Deviation|Mean
2838440|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 84|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.|||Percentage of participants||95% Confidence Interval|Number
2838441|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 60|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.|||Percentage of participants||95% Confidence Interval|Number
2838442|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 36|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.|||Percentage of participants||95% Confidence Interval|Number
2838443|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 84|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2838444|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 60|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2838445|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 36|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2838446|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 84|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2838447|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 60|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2838448|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 36|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2838460|NCT00205699|Secondary|Change in Insulin-stimulated Glucose Rate of Appearance (Glucose Ra)|This study hypothesized that antipsychotic treatment would decrease hepatic insulin sensitivity, as measured by the rate of appearance of glucose (glucose Ra), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||percentage of % change||Standard Deviation|Mean
2838449|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 84|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 84|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Breast cancer per 1000-women years|||Number
2838450|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 60|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 60|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Breast cancer per 1000-women years|||Number
2838451|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 36|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 36|Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Breast cancer per 1000-women years|||Number
2838452|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 84|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 84|Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.|||Percentage of participants||95% Confidence Interval|Number
2838453|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 60|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percentage of participants||95% Confidence Interval|Number
2838454|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 36|New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 36|Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.|||Percentage of participants||95% Confidence Interval|Number
2838455|NCT00205712|Secondary|Visual Analog Scale (VAS) Anxiety Rating|Anxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up||||Scale of 1-10||Standard Deviation|Mean
2838456|NCT00205712|Secondary|Visual Analog Scale (VAS) Pain Intensity|Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.|||Scale of 1-10||Standard Deviation|Mean
2838457|NCT00205712|Primary|Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score|Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)|Before Ketamine, During Ketamine|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.|||Scale of 0-6||Standard Deviation|Mean
2838458|NCT00205699|Secondary|Change in MRI-measured Subcutaneous Abdominal Fat|This study hypothesized that antipsychotic treatment would increase subcutaneous abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||Change in cm-squared||Standard Deviation|Mean
2838459|NCT00205699|Secondary|Change in MRI-measured Visceral Abdominal Fat|This study hypothesized that antipsychotic treatment would increase visceral abdominal fat, as measured by abdominal magnetic resonance imaging (MRI), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||Change in cm-squared||Standard Deviation|Mean
2838462|NCT00205699|Primary|Change in Insulin-stimulated Glucose Rate of Disappearance (Glucose Rd)|This study hypothesized that antipsychotic treatment would decrease insulin sensitivity at muscle, as measured by the insulin-stimulated rate of disappearance of glucose (glucose Rd), with larger adverse effects for olanzapine.|12 weeks|Children ages 6-18 with a Diagnostic and Statistical Manual Text Revision (DSM-IV-TR) diagnosis and clinically significant aggression or irritability|||percentage of % change||Standard Deviation|Mean
2838463|NCT00205699|Primary|Change in DEXA % Body Fat|This study hypothesized that antipsychotic treatment would increase percent total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.|12 weeks|Modified Intent to Treat (ITT) sample with week 0 and week 12 data.|||percent body fat||Standard Deviation|Mean
2838464|NCT00205660|Primary|Change in Whole Body Sensitivity (mg/kg/Min)|This study hypothesized that switching to aripiprazole treatment will be associated with statistically significant improvements in whole body sensitivity (mg/kg/min) in comparison to chronic pretreatment with olanzapine.|12 Weeks|"The analysis was per protocol and included subjects that completed both a baseline and endpoint assessment, which in this case, was a hyperinsulinemic euglycemic clamp."|||change in mg/kg/min||Standard Deviation|Mean
2838465|NCT00205660|Primary|Change in Total Body Fat (kg).|This study hypothesizes that switching to aripiprazole treatment will be associated with reductions in adipose tissue mass in comparison to olanzapine.|12 Weeks|"The analysis was per protocol and included subjects that completed both a baseline and endpoint assessment, which in this case, was a DEXA scan."|||change in kilograms||Standard Deviation|Mean
2838466|NCT00205504|Secondary|Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).|Baseline and 6 months||||ng/mL||Standard Deviation|Mean
2838467|NCT00205504|Secondary|Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months||||cm||Standard Deviation|Mean
2838468|NCT00205504|Secondary|Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Body Mass Index is a calculation of height and weight: kg/m²|Baseline and 6 months||||kg/m²||Standard Deviation|Mean
2838469|NCT00205504|Secondary|Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months||||mm Hg||Standard Deviation|Mean
2838470|NCT00205504|Secondary|Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).|Baseline and 6 months||||pg/mL||Standard Deviation|Mean
2838471|NCT00205504|Secondary|Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.|Baseline and 6 months||||ratio||Standard Deviation|Mean
2838472|NCT00205504|Secondary|Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months||||pg/mL||Standard Deviation|Mean
2838473|NCT00205504|Secondary|Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.|Baseline and 6 months||||ng/mL||Standard Deviation|Mean
2838474|NCT00205504|Secondary|Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women|The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).|Baseline and 6 months||||mg/dL||Standard Deviation|Mean
2838475|NCT00205504|Primary|Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women|Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).|Baseline and 6 months||||mIU/L||Standard Deviation|Mean
2838476|NCT00205374|Secondary|12-month Change in Voice Handicap Index (VHI) Score|"Voice Handicap Index. This scale rates a patient's perception of voice related handicap in the domains of functional, physical, and emotional. There are 10 questions for each domain. Each question is rated by the subject on a 5-point scale, never =0, almost never =1, sometimes =2, almost always =3, always =4). A lower total score or domain score indicates improved, or less, voice handicap. Thus, the maximum total score is 4 X 30 = 120. For each domain, the maximum score is 4 X 10 = 40. Scores of 0 are the lowest possible score. In the paper we say that the Maximum score is 100, but obviously is it actually 120. Complete scale = 0-120.~Lower score indicates improved perceived voice-realted quality of life."|2 months, and 12 months|[raw data no longer exist for this study, there a no data to report for a Baseline measure]|||scores on a scale||Full Range|Mean
2838477|NCT00205374|Primary|Change in Papilloma Severity|"Derkay Severity Score. Minimum Score is Zero. Maximum score is 86. Treatment of RRP with cidofovir injection will be considered efficacious if drug group patients experience clinically or statistically significant changes in papilloma severity and inter-surgery time intervals (relative to pre-treatment assessments), when compared with placebo group patients.~The scale rates - Voice (normal 0, abnormal 1, aphonic 2) Stridor (absent 0, present with activity 1, present at rest 2) Urgency of the intervention (scheduled 0, elective 1, urgent 2, emergent 3) Respiratory distress (none 0, mild 1, mod 2, severe 3, extreme 4).~For multiple anatomical sites (18 or more) in the upper airway, left and right sides, lesions are rated as 0=none, 1=surface lesion, 2=raised lesion, and 3=bulky lesion).~A higher rating value indicates more advanced disease and a worse outcome."|Baseline, 2 months, and 12 months||||scores on a scale||Full Range|Mean
2838501|NCT00205179|Primary|Measure of Selective Attention: Time to Complete Stroop Color Word Test|"Selective attention was evaluated with the Stroop Color Word Interference Test. In the interference portion of this test, the subject identifies the color of ink in which words (red, green, or blue) are printed, requiring the subject to inhibit their natural tendency to read the word. A subject's score is the time taken to identify 50 stimulus items.~The time taken to complete the maze is inversely proportional to the cognitive function."|6 months||||Seconds||Standard Error|Mean
2839200|NCT00194675|Secondary|Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)||Baseline, 3-months, 6-months|per protocol|||cc/sec||Standard Deviation|Mean
2838478|NCT00205348|Primary|Swallowing Quality of Life|The swallowing quality of life (SWAL-QOL) validated outcomes assessment tool will be used before and one year after surgery to measure changes in swallowing-related QOL in patients undergoing thyroid surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function. A score of 0 represents the least favorable state, and 100 the most favorable. It has been validated and has favorable psychometric properties, including high internal-consistency reliability and reproducibility. The scales of the instrument differentiate patients with oropharyngeal dysphagia from normal swallowers and are sensitive to clinically-relevant differences in dysphagia severity in patients with medically and surgically treated conditions.|One year|All data will be analyzed using standard statistical tools including student T-test and ANOVA.|||units on a scale||Full Range|Mean
2838479|NCT00205179|Secondary|Plasma Concentrations of Estradiol at 6 Month|Estradiol assay will be performed on non-fasting blood samples collected at baseline using an enzyme immunoassay kit.|At 6 month|Estradiol analysis done by the same investigator as part of another project with different subjects (PMID: 9054783 linked in the citation), did not show any change in the estradiol levels. Based on that, investigators did not see the justification for running these analyses in the current study. No estradiol analyses were performed for this study.||||||
2838480|NCT00205179|Secondary|Plasma Concentrations of Estradiol at 3 Month|Estradiol assay will be performed on non-fasting blood samples collected at baseline using an enzyme immunoassay kit.|At 3 month|Estradiol analysis done by the same investigator as part of another project with different subjects (PMID: 9054783 linked in the citation), did not show any change in the estradiol levels. Based on that, investigators did not see the justification for running these analyses in the current study. No estradiol analyses were performed for this study.||||||
2838481|NCT00205179|Secondary|Plasma Concentrations of Estradiol at Baseline|Estradiol assay will be performed on non-fasting blood samples collected at baseline using an enzyme immunoassay kit.|baseline|Estradiol analysis done by the same investigator as part of another project with different subjects (PMID: 9054783 linked in the citation), did not show any change in the estradiol levels. Based on that, investigators did not see the justification for running these analyses in the current study. No estradiol analyses were performed for this study.||||||
2838482|NCT00205179|Secondary|Plasma Concentrations of Isoflavones at Month 6|"Isoflavone assays will be performed on non-fasting blood samples collected at month 6.~Novasoy capsules predominantly contain purified glycoside forms of isoflavones known genistein and diadzein. The plasma level of genistein and diadzine will be measured in the participants plasma.There is large inter-individual variations in the extent of intestinal metabolism, even when the quantity of isoflavone intake is standardized. Equol is a metabolite of isoflavones. Equol has high biological efficacy. Therefore, along with genistein and diadzein, plasma levels of equol will be measured to understand the isoflavone metabolism in the participants."|At month 6|Data is unavailable for 1 subject from placebo group and 3 subjects from Novasoy group|||ng/ml||Standard Deviation|Mean
2838483|NCT00205179|Secondary|Plasma Concentrations of Isoflavones at Month 3|"Isoflavone assays will be performed on non-fasting blood samples collected at month 3.~Novasoy capsules predominantly contain purified glycoside forms of isoflavones known genistein and diadzein. The plasma level of genistein and diadzine will be measured in the participants plasma.There is large inter-individual variations in the extent of intestinal metabolism, even when the quantity of isoflavone intake is standardized. Equol is a metabolite of isoflavones. Equol has high biological efficacy. Therefore, along with genistein and diadzein, plasma levels of equol will be measured to understand the isoflavone metabolism in the participants."|At month 3|Data is unavailable for 1 subject from each group|||ng/ml||Standard Deviation|Mean
2838484|NCT00205179|Secondary|Plasma Concentrations of Isoflavones at Baseline|"Isoflavone assays will be performed on non-fasting blood samples collected at baseline.~Novasoy capsules predominantly contain purified glycoside forms of isoflavones known genistein and diadzein. The plasma level of genistein and diadzine will be measured in the participants plasma.There is large inter-individual variations in the extent of intestinal metabolism, even when the quantity of isoflavone intake is standardized. Equol is a metabolite of isoflavones. Equol has high biological efficacy. Therefore, along with genistein and diadzein, plasma levels of equol will be measured to understand the isoflavone metabolism in the participants."|baseline|Data is unavailable for 2 subject from placebo group and 1 subjects from Novasoy group|||ng/ml||Standard Deviation|Mean
2838485|NCT00205179|Secondary|Number of Participants With ApoE4 Allele|"The epsilon-4 allele of the apolipoprotein E gene (APOE4) has been consistently associated with a greater risk of Alzheimer's disease (AD) as well as an earlier onset of AD.~Determination of apolipoprotein E (APOE) genotype was performed on a non-fasting blood sample collected at Baseline, using standard Polymerase chain reaction (PCR) and DNA sequencing techniques in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. DNA extracted from whole blood was amplified by PCR using specific primers for the ApoE gene and the DNA then sequenced and analyzed for genotype using the FinchTV program (Version 1.3; Geospiza, Inc.)"|Baseline|Older adults with Alzheimer's disease|||Participants|||Count of Participants
2838486|NCT00205179|Secondary|Geriatric Depression Scale-Study Partner Report|"Study partner is someone who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to all clinic visits for the duration of the protocol.~Study partner will report a short form GDS consisting of 15 questions. Out of 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively.~Scores of 0-4 are considered normal, depending on age, education, and complaints; Scores of 5-8 indicate mild depression; 9-11 indicate moderate depression; and Scores of 12-15 indicate severe depression.~The Short Form is more easily used by physically ill and mildly to moderately demented patients who have short attention spans and/or feel easily fatigued. It takes about 5 to 7 minutes to complete."|6 months||||score on a scale||Standard Error|Mean
2838502|NCT00205179|Primary|A Test of Planning: Time to Complete Mazes|Time to complete mazes is a test of planning. Subjects are asked to complete a set of 3 mazes. The time taken to complete the maze is inversely proportional to the cognitive function.|6 months||||Seconds||Standard Error|Mean
2839771|NCT00185640|Secondary|Incidence of Relapse|Reports the overall rate of disease relapse, occurring any time within 3 years after transplant|3 years||||percentage of participants|||Number
2838487|NCT00205179|Secondary|Geriatric Depression Scale-Subject Report|"Geriatric Depression Scale (GDS) has been tested and used extensively with the older population to measure depression.~Subject will self-report a short form GDS consisting of 15 questions. Out of 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively.~Scores of 0-4 are considered normal, depending on age, education, and complaints; Scores of 5-8 indicate mild depression; 9-11 indicate moderate depression; and Scores of 12-15 indicate severe depression.~The Short Form is more easily used by physically ill and mildly to moderately demented patients who have short attention spans and/or feel easily fatigued. It takes about 5 to 7 minutes to complete"|6 months||||score on a scale||Standard Error|Mean
2838488|NCT00205179|Secondary|Multiple Mood States: Profile of Mood States (POMS)-Confusion Scale|Confusion scale is one of the subscale of POMS. Confusion scale has 7 items and scores ranges from 0-28. Higher score indicates more severe outcomes.|6 months||||score on a scale||Standard Error|Mean
2838489|NCT00205179|Secondary|Multiple Mood States: Profile of Mood States (POMS)-Vigor Scale|Vigor scale is one of the subscale of POMS. Vigor scale has 8 items and scores ranges from 0-32. Higher score indicates more severe outcomes.|6 months||||score on a scale||Standard Error|Mean
2838490|NCT00205179|Secondary|Multiple Mood States: Profile of Mood States (POMS)-Fatigue Scale|Fatigue scale is one of the subscale of POMS. Tension scale has 7 items and scores ranges from 0-28. Higher score indicates more fatigue.|6 months||||score on a scale||Standard Error|Mean
2838491|NCT00205179|Secondary|Multiple Mood States: Profile of Mood States (POMS)-Anger Scale|Anger scale is one of the subscale of POMS. Tension scale has 12 items and scores ranges from 0-48. Higher score indicates more anger issues.|6 months||||score on a scale||Standard Error|Mean
2838492|NCT00205179|Secondary|Multiple Mood States: Profile of Mood States (POMS)-Tension Scale|Tension scale is one of the subscale of POMS. Tension scale has 9 items and scores ranges from 0-36. Higher score indicates more severe outcomes.|6 months||||score on a scale||Standard Error|Mean
2838493|NCT00205179|Secondary|Multiple Mood States: Profile of Mood States (POMS)-Depression Scale|Depression scale is one of the subscale of POMS. Depression scale has 15 items and scores ranges from 0-60. Higher score indicates more severe depression.|6 months||||score on a scale||Standard Error|Mean
2838494|NCT00205179|Secondary|Cognitive Outcomes-Global Cognition : Mini-Mental State Examination (MMSE) Score|"During the MMSE, a health professional asks a participant a series of questions designed to test memory, ability to solve simple problems and other thinking skills.~The maximum MMSE score - 30 points. Score of 20 to 24 - mild dementia, 13 to 20 - moderate dementia, and <12 indicates severe dementia.~On average, the MMSE score of a person with Alzheimer's declines about 2 to 4 points each year."|6 months||||score on a scale||Standard Deviation|Mean
2838495|NCT00205179|Secondary|Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Non-Dominant Hand|The Grooved Pegboard is a dexterity test consisting of 25 holes with randomly positioned slots. Pegs with a key on one side must be rotated to match the hole before they can be inserted. Participants are instructed to place all pegs into the 25 holes, picking up one at a time, and using just one hand. They use their non-dominant hand. Time taken to finish the test inversely correlates to the cognitive ability.|6 months||||time in seconds||Standard Error|Mean
2838496|NCT00205179|Secondary|Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Dominant Hand|The Grooved Pegboard is a dexterity test consisting of 25 holes with randomly positioned slots. Pegs with a key on one side must be rotated to match the hole before they can be inserted. Participants are instructed to place all pegs into the 25 holes, picking up one at a time, and using just one hand. They use their dominant hand. Time taken to finish the test inversely correlates to the cognitive ability.|6 months||||time in seconds||Standard Error|Mean
2838497|NCT00205179|Secondary|Cognitive Outcomes - Visual Motor : Complex Figure Copy; Number of Points|Visual memory will be evaluated by Complex Figure copy test. The Complex Figure Test assesses the subject's ability to copy a 2-dimensional figure. The scoring system used include scores related to location, accuracy and organization. Higher score correlates to better visual memory.|6 months||||number of points||Standard Error|Mean
2838498|NCT00205179|Primary|Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors|"The Benton Visual Retention Test is an individually administered test for people aged from 8 years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory. The individual examined is shown 10 designs, one at a time, and asked to reproduce each one as exactly as possible on plain paper from memory. The test is untimed, and the results are professionally scored by form, shape, pattern, and arrangement on the paper.~For the 'test of number of errors' score is calculated based on the number and type of errors made for each design. The major categories for these errors are omissions, distortions, perseverations, rotations, misplacements, and size errors.These scores are then be compared to several sets of normative data available in the manual, each representing different demographic characteristics, and conclusions can be drawn by the examiner."|6 months||||Number of errors||Standard Error|Mean
2838499|NCT00205179|Primary|Visual Memory : Benton Visual Retention Test: Number of Correct Figures|"The Benton Visual Retention Test (or simply Benton test or BVRT) is an individually administered test for people aged from 8 years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory. The individual examined is shown 10 designs, one at a time, and asked to reproduce each one as exactly as possible on plain paper from memory. The test is untimed, and the results are professionally scored by form, shape, pattern, and arrangement on the paper.~For the 'test of number of correct figures' score is calculated based on an all-or-nothing approach; points are awarded if the reproduction of the design matches the original."|6 months||||number of correct figures||Standard Error|Mean
2838500|NCT00205179|Primary|Visual Memory Test: Complex Figure Delayed Recall; Number of Points|Visual memory will be evaluated by complex figure delayed recall test. In this test , a two dimensional figure is shown to the subjects. After a delay of 30 min, they are asked to draw the same figure based on their memory. The Complex Figure Test assesses the subject's ability to remember a 2-dimensional figure presented briefly. The scoring system used includes scores related to location, accuracy and organization. Higher score correlates to better visual memory.|6 months||||number of points||Standard Error|Mean
2838503|NCT00205179|Primary|Measure of Divided Attention: Time to Complete Trail Making Test B|"Trail Making Test-Version B (TMT B) [113], a measure of divided attention, the subject is asked to draw lines to connect consecutively numbered and lettered circles, alternating between the 2 sequences. The time needed to complete the task is recorded.~More time taken to complete the test or higher score indicates lower executive function/higher impairment."|6 months||||Seconds||Standard Error|Mean
2838504|NCT00205179|Primary|Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled|In the logical delayed memory test, participants are read a logically organized story. Approximately 20 minutes later, the participants are asked to recall the story from memory (Delayed Recall). The version used in this study uses only one story (Story A) read once to participants at each study visit. Possible scores for delayed recall trials range from 0 to 25, with higher scores reflecting more details recalled.|6 months||||Number of story elements recalled||Standard Error|Mean
2838505|NCT00205179|Primary|Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled|List of 15 semantically unrelated words is presented verbally to the participants once, after which they are asked to free recall as many words as possible. Subsequently, this presentation‐test routine (learning trials) is repeated four more times. A total recall score is determined by adding the number of recalled items for the five learning trials. After presentation of a distractor list and a delay of approximately 20 minutes, participants are asked to freely recall items from the original word list. A delayed recall score is then derived from this test.|6 months||||Number of words recalled||Standard Error|Mean
2838506|NCT00205179|Primary|Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute|Participants are given 1 min to produce as many words as possible starting with a given letter (letter fluency). More number of words per minute correlates to better phonemic fluency/verbal fluency|6 months||||number of words generated per minute||Standard Error|Mean
2838507|NCT00205179|Primary|Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min|Participants are given 1 min to produce as many unique words as possible within a category (category fluency). More words per minute will correlates to better category fluency|6 months||||number of words generated per minute||Standard Error|Mean
2838508|NCT00205049|Primary|Survival at 28 Days||28 days|Study was terminated before any data was gathered/analyzed.||||||
2838509|NCT00204932|Secondary|Total Fat Oxidation|24 hour respiratory gas analysis|6 months|||||||
2838510|NCT00204932|Primary|Fat Mass|loss of fat mass, kg|6 months||||kg||Standard Deviation|Mean
2838511|NCT00204373|Secondary|The Median Survival From the Time of Diagnosis.|The median survival from the time of diagnosis|survival or up to 240 months||||years||Standard Deviation|Median
2838512|NCT00204373|Primary|Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.|number of participants with control of gastric acid production|up to 240 months from study enrollment||||participants|||Number
2838513|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|3 nights|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.|||mU/(liter x min)||Standard Error|Mean
2838514|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|Baseline|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.|||mU/(liter x min)||Standard Error|Mean
2838515|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||nanogram/milliliter||Standard Error|Mean
2838516|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||nanogram/milliliter||Standard Error|Mean
2838517|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||microgram/deciliter||Standard Error|Mean
2838678|NCT00200967|Secondary|Exhaled Nitric Oxide (eNO)|Change between placebo salmeterol and active salmeterol for eNO|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||parts per billion||95% Confidence Interval|Geometric Mean
2838518|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
2838519|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
2838520|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||microgram/deciliter||Standard Error|Mean
2838521|NCT00203996|Secondary|Aim 1: Visceral Adiposity [After Treatment]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.||||||
2838522|NCT00203996|Secondary|Aim 1: Visceral Adiposity [Baseline]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.||||||
2838523|NCT00203996|Secondary|Aim 1: Blood Pressure [After Treatment]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|8 weeks|No participants were randomized to these study arms.||||||
2838524|NCT00203996|Secondary|Aim 1: Blood Pressure [Baseline]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|baseline (0 weeks)|No participants were randomized to these study arms.||||||
2838525|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
2838526|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.|||mU/(liter x min)||Standard Error|Mean
2838527|NCT00203996|Primary|Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]|Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|8 weeks|No participants were randomized to these study arms.||||||
2838528|NCT00203996|Primary|Aim 1: Apnea-Hypopnea Index (AHI) [Baseline]|Apnea-hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|baseline|No participants were randomized to these study arms.||||||
2838529|NCT00203931|Secondary|Progression-free Survival Based on Serum Biomarker Status|Progression-free survival in this analysis looking at the association between a serum proteomic biomarker and progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 10 patients did not have a pre-treatment/baseline serum marker classification and thus were excluded from this analysis.|||months||95% Confidence Interval|Median
2838530|NCT00203931|Secondary|Overall Survival|Overall survival will be defined as the time from the start of treatment until death from any cause.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)|||months||95% Confidence Interval|Median
2838531|NCT00203931|Secondary|Objective Response Rate|Objective response (complete response [CR] + partial response [PR]) will be evaluated using RECIST criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter of target lesions.|up to 2 years|Includes evaluable patients (those that received at least 3 doses of cetuximab).|||percentage of participants||95% Confidence Interval|Number
2838611|NCT00201877|Primary|Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Day 1 of each cycle|grade 3 neurotoxicity which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension|||patients|||Number
2838532|NCT00203931|Secondary|Progression-free Survival Based on Rash Development|Progression-free survival in this landmark analysis looking at the utility of early rash in predicting progression-free survival will be defined as the time from day 22 of study therapy until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first. Patients last known to be alive and progression-free were censored at the date of the last scan without evidence of progression.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 2 patients died or progressed prior to day 22 of cetuximab therapy and thus were excluded from this analysis.|||months||Standard Error|Median
2838533|NCT00203931|Primary|Progression-free Survival|Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)|||months||95% Confidence Interval|Median
2838534|NCT00203892|Secondary|Evidence of Dose Limiting Toxicities of Immunization With Modified CEA (Carcinoembryonic Antigen) Peptide.|Dose-limited toxicity included Grade 2 or higher hemorrhage or allergic reaction or clinical evidence of autoimmune disease. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v2.0.|participants were followed while they were on study treatment, a median of 8 weeks||||participants|||Number
2838535|NCT00203892|Primary|Maximum T Cell Response From Baseline|"T cell frequency (spots per 10^4 CD8+ cells) was measured by ELISPOT (Enzyme-linked immunosorbent spot) assay. Blood was collected for this assay at baseline and every 4 weeks for the first 8 cycles. After the eighth cycle, a blood sample was collected at the time of disease progression. The maximum T cell response was calculated as: peak value on treatment - baseline value.~A positive value indicates an increase from baseline."|baseline and every 4 weeks on treatment|The analysis population for the primary outcome included the 14 patients who received at least 3 doses of the CEA vaccine and had a ELISPOT at least at baseline and after the 3rd cycle.|||spots per 10^4 CD8+ cells||Full Range|Median
2838536|NCT00203502|Secondary|Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer|pCR rate for triple negative patients--percent|at surgery, one day|Patients with triple negative breast cancer|||% pCR among triple negative pts||90% Confidence Interval|Number
2838537|NCT00203502|Secondary|To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline|Absolute change in LVEF, where LVEF values are measured in percentage units|Immediately before treatment and 1 year after start of treatment||||Percentage of LVEF||Standard Deviation|Mean
2838538|NCT00203502|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events|Percent of participants who had at least one grade 3 or 4 adverse event|After each chemotherapy infusion, approximately one hour||||percentage of pts w/ grade 3/4 AE||90% Confidence Interval|Number
2838539|NCT00203502|Secondary|Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.|Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy|At completion of chemotherapy treatment, an average of one hour|All participants evaluated surgically|||percentage of pts w/ cCR||90% Confidence Interval|Number
2838540|NCT00203502|Primary|Percentage of Participants With Pathological Complete Response.|Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.|Participants were assessed during surgery, an average of one hour||||percentage of evaluable patients||90% Confidence Interval|Number
2838541|NCT00203476|Secondary|Change in HDL From Baseline to 12 Weeks.||baseline and 12 weeks|Change in HDL|||mg/dl||Standard Deviation|Mean
2838542|NCT00203476|Secondary|Incidents of Rhabdomyolysis||12 weeks||||participants|||Number
2838543|NCT00203476|Secondary|LFT Elevation||12 weeks||||participants|||Number
2838544|NCT00203476|Primary|LDL Goal Attainment|Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.|12 weeks|intention to treat|||participants|||Number
2838545|NCT00203424|Secondary|Overall Survival||Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment||||participants|||Number
2838546|NCT00203424|Primary|Time to Tumor Recurrence||Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment||||days||Full Range|Mean
2838547|NCT00203424|Secondary|Time to Tumor Progression.|Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence|Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment||||days|||Number
2838548|NCT00203424|Primary|To Evaluate the Efficacy of Bevacizumab Plus Erlotinib||Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.|Of the 23 subjects registered for treatment, 19 were analysed for efficacy, 4 subjects were excluded from analysis because of withdrawal of subjects prior to first tumor assessment.|||participants|||Number
2838549|NCT00203411|Secondary|Quality of Life of Patients|"Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) - a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.~The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.~The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 'Best imaginable health state' and 100 'Worst imaginable health state'."|Baseline, Cycle 2, and End of Study||||score on a scale||Standard Deviation|Mean
2838612|NCT00201877|Primary|Overall Response Rate|To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™.|Every 3 months||||percentage of patients|||Number
2838550|NCT00203411|Secondary|Response Rates|Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|every 21 days up to 12 months||||participants|||Number
2838551|NCT00203411|Primary|Number of Subjects Requiring Dose Modifications|Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.|3 months|all subjects that received chemotherapy|||participants|||Number
2838552|NCT00203411|Primary|Time to Disease Progression|Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date|12 months||||months||95% Confidence Interval|Median
2838553|NCT00203307|Secondary|Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.||84 day period on olanzapine compared to 84 day period on placebo|||||||
2838554|NCT00203307|Secondary|Reduction of Migraine Attack Frequency During Each 28-day Interval of the Active Treatment Period as Compared to Each 28-day Interval of the Placebo Treatment Period, Per Subject. Individual Migraine Attacks Are Separated by 48-hours Pain Free Time. A||each 28 day interval of active treatment c ompared to placebo|||||||
2838555|NCT00203307|Primary|Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.|"Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present*.~Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112."|84 day period on placebo compared to 84 day period on olanzapine||||headache periods||Standard Deviation|Mean
2838556|NCT00203294|Secondary|To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes|||||||
2838557|NCT00203294|Secondary|To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes|||||||
2838558|NCT00203294|Primary|Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.||20 minutes|||||||
2838559|NCT00203294|Primary|Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain|Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment|20 minutes|There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).|||units on a scale||Standard Deviation|Mean
2838560|NCT00203268|Primary|Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.|Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.|2 hours post treatment and 4 hours post treatment||||participants|||Number
2838561|NCT00203242|Secondary|Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days.||Baseline compared to maintenance (up to 47 days)|||||||
2838562|NCT00203242|Secondary|Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values.||Compare Baseline through 47 days|||||||
2838563|NCT00203242|Primary|Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.|Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency.|baseline (day 0) through 47 days after first infusion||||days||Standard Deviation|Mean
2838564|NCT00203229|Primary|Average Number of Pain Attacks|The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.|Day 150 Visit #7||||Pain attacks||Standard Deviation|Mean
2838565|NCT00203216|Secondary|Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.||Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.|||||||
2838566|NCT00203216|Secondary|Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period||Baseline period compared to 28 day interval prior to Visit 4-7.|||||||
2838567|NCT00203216|Secondary|Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days)"|Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.|||||||
2838568|NCT00203216|Primary|The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI"|Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).||||migraine attacks per month||Standard Deviation|Mean
2838569|NCT00203203|Secondary|Linear Local Shortening (LLS)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.|baseline and 6 months||||percentage of linear local shortening||Standard Deviation|Mean
2838570|NCT00203203|Secondary|Endocardial Unipolar Voltages (UPV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.|baseline and 6 months|The data was analyzed for all participants in control and treated groups.|||Unipolar voltage (mV)||Standard Deviation|Mean
2838571|NCT00203203|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||ml||Standard Deviation|Mean
2838572|NCT00203203|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline, 3 months and 6 months||||Volume in left ventricle (milliliters)||Standard Deviation|Mean
2838573|NCT00203203|Secondary|Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the gold standard."|baseline and 6 months|The data was analyzed for all participants in control and treated groups.|||Angiography LVEF (%)||Standard Deviation|Mean
2838574|NCT00203203|Secondary|Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||Left Ventricular Ejection Fraction (%)||Standard Deviation|Mean
2838575|NCT00203203|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.|||Wall Motion Score Index||Standard Deviation|Mean
2838576|NCT00203203|Secondary|Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.|||VE/VCO2 slope||Standard Deviation|Mean
2838577|NCT00203203|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||Ejection Fraction %||Standard Deviation|Mean
2838578|NCT00203203|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||Percentage of Oxygen Saturation||Standard Deviation|Mean
2838613|NCT00201864|Secondary|Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels||Prestudy, Day 7 and Day 120|Increase in mean levels from baseline to day 120. Not all patients had the IGF-1 and IGFBP-3 levels present.|||ng/mL||Standard Deviation|Mean
2838579|NCT00203203|Secondary|New York Heart Association (NYHA)Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.~Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||NYHA Functional Class||Standard Deviation|Mean
2838580|NCT00203203|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).~Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.|||units on a scale||Standard Deviation|Mean
2838581|NCT00203203|Primary|Safety of Autologous-bone-marrow Injections|Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|up to 2 weeks post-procedure, 3 months and 6 months|Adverse events which occurred in all participants.|||participants|||Number
2838582|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions|"Results represent the database as of January 29, 2009.~The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage."|Day 0, Month 36 or early termination visit|Treated population of participants with an MRI at the stated time frames.|||cm^3||Standard Deviation|Mean
2838583|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions|"Results represent the database as of January 29, 2009.~The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden."|Day 0, Month 36 or the early termination visit|Treated population of participants with an MRI at the stated time frames.|||cm^3||Standard Deviation|Mean
2838584|NCT00203047|Secondary|Cumulative Number of Enhancing Lesions at Months 12, 24 and 36|"Results represent the database as of January 29, 2009.~Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered."|Months 12, 24, and 36|Treated population who had at least a 12 month MRI|||lesions||Standard Deviation|Mean
2838585|NCT00203047|Primary|Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method|"Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change.~Adjusted (least square) mean values are presented."|Day 0, latest scan at month 24, 36 or early termination visit|Treated population of participants who had both a baseline MRI and an MRI at least one of the three during study time frames. The latest MRI was used if more than one during study MRI was available.|||percent change of baseline brain volume||Standard Error|Least Squares Mean
2838586|NCT00203021|Primary|Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288|The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis).|Baseline, Month 288|01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.|||units on a scale||Standard Deviation|Mean
2838587|NCT00203021|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section.|Baseline up to Month 288|01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.|||participants|||Number
2838597|NCT00202644|Secondary|Change From Baseline in White Blood Cell Count Over Time|White blood cell count was evaluated throughout the study.|Baseline and Month 6, 12, 18, 24, 30 and 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively.|||10^9 cells per liter||Standard Deviation|Mean
2838614|NCT00201864|Secondary|Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant|5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.|Day 7 and Day 120|Only 9 patients had evaluable PK data collected and analyzed|||ng/ml||Standard Deviation|Mean
2838588|NCT00202878|Secondary|Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
2838589|NCT00202878|Secondary|Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
2838590|NCT00202878|Secondary|Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
2838591|NCT00202878|Primary|Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction [MI], documented unstable angina [UA] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
2838592|NCT00202839|Secondary|The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.|Virologic response was defined as undetectable HCV-RNA level in the blood.|48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)|Intention to treat [ITT] population|||Percentage of Participants|||Number
2838593|NCT00202839|Primary|The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy|24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy|Intention to treat [ITT] population defined as participants who received at least one dose of study medication.|||Percentage of participants|||Number
2838594|NCT00202722|Secondary|Patient Satisfaction|Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.|From start of remifentanil treatment until delivery||||Participants|||Number
2838595|NCT00202722|Primary|Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)|Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.|From start with remifentanil treatment until delivery, up to 8 hours.|Per protocol|||millimeters||Standard Deviation|Mean
2838596|NCT00202644|Secondary|Change From Baseline in Red Blood Cell Count Over Time|Red blood cell count was evaluated throughout the study.|Baseline and Month 6, 12, 18, 24, 30 and 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively.|||10^12 cells per liter||Standard Deviation|Mean
2838633|NCT00201734|Secondary|One Year Survival for Patients|For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial.|Up to 1 year||||percent of patients||95% Confidence Interval|Number
2838598|NCT00202644|Secondary|Number of Participants With Thrombotic and Haemorrhagic Events|Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment.|From the signing of informed consent until the last study-related visit (Month 36)|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||participants|||Number
2838599|NCT00202644|Secondary|Time to Partial Response|Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||days||95% Confidence Interval|Median
2838600|NCT00202644|Secondary|Time to Complete Response|Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||days||95% Confidence Interval|Median
2838601|NCT00202644|Secondary|Percentage of Participants With Partial Response|A partial response is defined as a platelet count of 400-600 x 10^9/Liter and a reduction in platelet count of at least 200 x 10^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart.|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||percentage of participants|||Number
2838602|NCT00202644|Secondary|Percentage of Participants With Complete Response|A complete response was defined as a platelet count of less than (<) 400x10^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart.|Baseline up to Month 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded.|||percenatge of participants|||Number
2838603|NCT00202644|Secondary|Change From Baseline in Platelet Counts at Month 3 and 36|Platelet count was evaluated throughout the study.|Baseline and Month 3 and 36|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded with last observation carried forward (LOCF). Here, n=number of participants analysed for specified category at specified time points in each arm respectively.|||10^9 platelets per liter||Standard Deviation|Mean
2838604|NCT00202644|Primary|Platelet Count at Month 6|Platelet count was evaluated.|Month 6|The FAS population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, N = Number of participants analysed in each arm for this outcome measure.|||10^9 platelets per liter||Standard Deviation|Mean
2838605|NCT00202644|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time|The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.|Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36|The Full Analysis Set (FAS) population included all randomized participants who received at least 1 dose of study medication and who had a pretreatment and at least 1 post baseline LVEF measurement recorded. Here, n = Number of participants analysed for specified category at the specified time points in each arm respectively.|||percentage of ejection fraction||Standard Deviation|Mean
2838606|NCT00202449|Primary|Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from baseline to Week 12.|Baseline to Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).|||scale points||Standard Deviation|Mean
2838607|NCT00202449|Primary|Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 12.|Baseline to Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at Week 12 (e.g., completed the study).|||scale points||Standard Deviation|Mean
2838608|NCT00202449|Primary|Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12. Minimum = 0 Maximum = 8"|Baseline and Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).|||scale points||Standard Deviation|Mean
2838609|NCT00201877|Secondary|Correlative Studies||During induction (weeks 1-15); PK every 2 months during maintenance.|Data not collected and analyzed||||||
2838610|NCT00201877|Secondary|Progression-free Survival(PFS)|To correlate serial plasma rituximab levels with response and progression-free survival.|2 years||||percentage of patients||95% Confidence Interval|Number
2838657|NCT00201240|Secondary|Transplant Related Mortality|Death occurring in a patient in continuing complete remission.|Months 12, 24, and 36||||percentage of participants||95% Confidence Interval|Number
2838615|NCT00201864|Secondary|Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)|"Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.~Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR"|Every 2 cycles, up to 1 year||||patients|||Number
2838616|NCT00201864|Primary|Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.|TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 2 cycles up to 2 years||||months||95% Confidence Interval|Median
2838617|NCT00201851|Primary|Disease-free Survival|5-year disease-free survival|two- to three-year accrual and initial two or more years of follow-up period||||percentage of participants|||Number
2838618|NCT00201838|Secondary|Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines||up to 6 months|Compare CBR with responders and non responders with available blood samples.|||delta Ct values||Standard Deviation|Mean
2838619|NCT00201838|Secondary|Median Overall Survival Rates for Patients|Median survival is defined as the time of initiation of the first dose of intervention to the date of death|up to 1 year|all evaluable patients|||months||95% Confidence Interval|Median
2838620|NCT00201838|Secondary|Percentage of Patients With Clinical Benefit Response|A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life).|Up to 12 months|All evaluable patients|||percentage of patients|||Number
2838621|NCT00201838|Secondary|Number of Patients With Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 months|"2 patients in the control group were non evaluable for disease response due to patient withdrawal and another no baseline imaging for comparison.~5 patients in experimental group were non evaluable for response."|||percentage of patients|||Number
2838622|NCT00201838|Primary|Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis.|up to 6 months|5 patients of the experimental group were non evaluable and 2 patients in the control group were non evaluable for disease progression.|||percent of patients with PFS|||Number
2838623|NCT00201825|Secondary|Pharmacokinetics||Cycle 2|No Pharmacokinetics were conducted for this trial.||||||
2838624|NCT00201825|Secondary|One Year Survival||one year||||months||95% Confidence Interval|Median
2838625|NCT00201825|Secondary|Time to Tumor Progression||Every 35 days||||months||95% Confidence Interval|Median
2838626|NCT00201825|Primary|Determine Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 35 days|One patient was not evaluable for response because the patient was removed from study afer an adverse event.|||patients|||Number
2838627|NCT00201773|Secondary|Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, <30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 16 weeks|Clinical Response was determined by physical exam and breast Ultrasound at baseline and repeated at 8 weeks and 16 weeks, and pathological response by histopathological examination of primary tumor and axillary nodes after definitive breast cancer surgery.|||patients|||Number
2838628|NCT00201773|Primary|Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane|Collected from postmenopausal women that receive neoadjuvant exemestane.|up to 16 weeks|Comparison of immunohistochemistry (IHC) Allred Differences with Neoadjuvant Therapy|||patients|||Number
2838629|NCT00201760|Secondary|Number of Participants With Grades 3 and Grade 4 Toxicity Profiles of the Drug Combinations|Adverse Events will be graded in accordance with the CTCAE Version 3.0 Toxicity grading criteria|Up to 24 months|Grades 3 and Grade 4|||patients|||Number
2838630|NCT00201760|Secondary|Measure Response Rate of Each Drug Combination|Response rate of the of the triple drug combination therapy and the double drug combination therapy regimens.|Up to 24 months||||patients|||Number
2838631|NCT00201760|Primary|Disease Progression|Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment|6 months||||Participants|||Count of Participants
2838632|NCT00201734|Secondary|Time to Tumor Progression for Patients|For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression.|Up to 6 years||||months||95% Confidence Interval|Median
2838634|NCT00201734|Secondary|Progression-Free Survival at 6 Months for Patients|For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 6 years||||percent of patients||95% Confidence Interval|Number
2838635|NCT00201734|Secondary|Phase I: To Determine Side Effects|The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0|Every 3 weeks, for up to 24 weeks|Three patients enrolled on Phase I portion of trial were not evaluable for toxicity.|||percent of patients|||Number
2838636|NCT00201734|Primary|Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 3 weeks, for up to 24 weeks|The Phase II study was prematurely terminated at 25 patients due to cessation of funding|||percent of patients||95% Confidence Interval|Number
2838637|NCT00201734|Primary|Maximum Tolerated Dose in Phase I Portion of Study|Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin.|Every 3 weeks, for up to 24 weeks||||mg/m2|||Number
2838638|NCT00201643|Secondary|Maternal Infectious Morbidity.|Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth|Up to 28 days after giving birth|ITT|||participants|||Number
2838639|NCT00201643|Secondary|Number of Neonates With Pneumothorax|Total number of neonates with pneumothorax diagnosed postpartum.|birth to 28 days of life|ITT|||participants|||Number
2838640|NCT00201643|Secondary|Number of Neonates Who Required Surfactant Therapy After Birth.|The Number of neonates who required surfactant therapy within the first 28 days after birth.|Birth to 28 days of life|ITT|||participant|||Number
2838641|NCT00201643|Secondary|Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.|The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day.|birth to 28 days of life|Intent to treat (ITT)|||participants|||Number
2838642|NCT00201643|Secondary|Neonatal Head Circumference Taken at Time of Birth.|Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group.|Birth|Intent to treat|||centemeters (cm)||Standard Deviation|Mean
2838643|NCT00201643|Secondary|Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.|Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth.|Measured at birth.|Intent to Treat|||paticipants|||Number
2838644|NCT00201643|Secondary|Neonatal Birth Weight Reported in Grams|Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record.|At time of Birth|Intent to treat protocol|||grams||Standard Deviation|Mean
2838645|NCT00201643|Secondary|Gestational Age at (@) Delivery|Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo).|gestational age at delivery in weeks of gestation|Modified intent to treat|||Weeks||Standard Deviation|Mean
2838646|NCT00201643|Primary|Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.|This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death|From birth to 28 days of life|This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%).|||participants|||Number
2838647|NCT00201448|Primary|Immunology Response|The primary objective of the study is to evaluate safety and immune responses induced by the Towne vaccine in in seronegative women with children in daycare|Urine, saliva, will be collected every 2 months for 12 months and serum will be collected 1,2,4,6, 9, 12, 18, 24, 30 and 36 months after vaccination.|Study was terminated (suspended due to lack of funding). PI is no longer with the institution; data and results cannot be accessed, analyzed, and reported.||||||
2838648|NCT00201448|Primary|Participants With Adverse Events||One year|per protocol and randomized|||participants|||Number
2838649|NCT00201409|Secondary|Days Without Organ Failure|Non-respiratory|Measured at Day 28||||days||Standard Deviation|Mean
2838650|NCT00201409|Secondary|Oxygenation Index Change at Day 15 From Day 1|The oxygenation index is a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body. It is calculated as the fraction of inspired oxygen times Mean airway pressure)/Partial pressure of oxygen in arterial blood Day 15 minus first day drug or placebo administered (Day 1).|Day 1, Day 15||||oxygenation index||Standard Deviation|Mean
2838651|NCT00201409|Primary|Ventilator-free Days During Days 1-28||Measured at Day 28||||Days||Standard Deviation|Mean
2838652|NCT00201240|Secondary|Post-transplant Lymphoproliferative Disorder (PTLD)|PTLD is defined as increased Epstein Barr Virus viremia requiring clinical intervention.|Year 2||||participants|||Number
2838653|NCT00201240|Secondary|CD34+ and CD3+ Cell Doses|Total CD34+ and CD3+ cell doses will be calculated based on results of flow cytometric analysis.|Day 0||||cells per kilogram||Full Range|Median
2838654|NCT00201240|Secondary|Overall Survival|Overall survival is defined as time from transplant to death or last follow-up.|Months 12 and 36||||percentage of participants||95% Confidence Interval|Number
2838655|NCT00201240|Secondary|Disease-free Survival (DFS)|DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow-up, from the time of transplant.|Months 6, 12, and 36||||percentage of participants||95% Confidence Interval|Number
2838656|NCT00201240|Secondary|Determination of Infusional Toxicity||28 day|No data collected||||||
2838664|NCT00201240|Primary|Probability of Disease-free Survival (DFS) at 6 Months Post-transplant (Death or Relapse Will be Considered Events for This Endpoint)|The primary analysis will consist of estimating the 6-month DFS (from day of enrollment) probability based on the Kaplan-Meier product limit estimator. The 6-month DFS probability and confidence interval will be calculated. All registered patients will be considered for this analysis.|6 months|All transplanted patients|||percentage of patients||95% Confidence Interval|Number
2838665|NCT00201201|Secondary|Satisfaction With the APRN Provider Relationship|"The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:not at all easy to 5: very easy)."|Measured at 0, 12 weeks on visit 1 and 4|There 69 participants in the control group and 82 participants in the education intervention group who chose to complete the satisfaction with the APRN provider on visit one and 65 in the control group and 75 in the education intervention group who chose to complete the survey on visit 4.|||units on a scale of 1-5||Standard Deviation|Mean
2838666|NCT00201201|Secondary|Satisfaction With the PEP-NG|"The PEP-NG user Satisfaction scale is a 14-item instrument - with eight items addressing the ease of program use, program content, and suitability of program content - and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, strongly disagree to 5, strongly agree) were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG."|Measured at 12 weeks||||units on a scale||Standard Deviation|Mean
2838667|NCT00201201|Secondary|Prescription/Over the Counter (Rx-OTC) Knowledge|The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.|Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4||||percentage of questions correct||Standard Deviation|Mean
2838668|NCT00201201|Secondary|Self-efficacy for Avoiding Adverse Self-medication Behaviors|"The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, Not Sure to 5, Totally Sure). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors."|Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4||||units on a scale||Standard Deviation|Mean
2838669|NCT00201201|Primary|Blood Pressure (BP) Readings: Systolic Blood Pressure|BP measurements were taken by the APRN at each of 4 visits - at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.|Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4||||mm Hg||Standard Deviation|Mean
2838670|NCT00201201|Primary|Behaviors Risk Score|"Using a five-point scale from 1, very unlikely to 5, very likely, a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors."|Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4||||units on a scale||Standard Deviation|Mean
2838671|NCT00201123|Secondary|Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.|||cells/mL||Inter-Quartile Range|Median
2838672|NCT00201123|Secondary|Chest Cavity Size||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.|||millimeters||Standard Deviation|Mean
2838673|NCT00201123|Primary|Sputum Conversion||Measured at 16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.|||percentage of participants|||Number
2838674|NCT00201006|Primary|Change in Body Weight.|Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.|one year|Data from all randomized participants were analyzed according to the Intent to Treatment principle. Missing data (6%) were completed based on known pattern of weight regain (i.e., 0.3 kg per month).|||kg||Standard Error|Mean
2838675|NCT00200967|Secondary|Asthma Control Questionnaire (ACQ)|Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control).|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2838676|NCT00200967|Secondary|Methacholine Provocative Concentration 20 (PC20)|Change between placebo salmeterol and active salmeterol for methacholine PC20|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||milligrams per milliliter||95% Confidence Interval|Geometric Mean
2838677|NCT00200967|Secondary|Exhaled Breath Condensate (EBC)|Change between placebo salmeterol and active salmeterol for EBC|Clinic visits at weeks 0, 10, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||pH||95% Confidence Interval|Least Squares Mean
2838679|NCT00200967|Secondary|Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters per minute||95% Confidence Interval|Least Squares Mean
2838680|NCT00200967|Secondary|Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters||95% Confidence Interval|Least Squares Mean
2838681|NCT00200967|Secondary|Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters||95% Confidence Interval|Least Squares Mean
2838682|NCT00200967|Secondary|Rescue Medication (Ipratropium and Albuterol) Use|Change between placebo salmeterol and active salmeterol for rescue medication use|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||puffs per day||95% Confidence Interval|Mean
2838683|NCT00200967|Secondary|Asthma Symptoms|Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe).|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||units on a scale||95% Confidence Interval|Mean
2838684|NCT00200967|Secondary|Peak Expiratory Flow (PEF) Variability|Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF)|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||percentage||95% Confidence Interval|Least Squares Mean
2838685|NCT00200967|Secondary|Evening (PM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for PM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters per minute||95% Confidence Interval|Least Squares Mean
2838686|NCT00200967|Primary|Morning (AM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for AM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An intention-to-treat (ITT) paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.|||liters per minute||95% Confidence Interval|Least Squares Mean
2838687|NCT00200902|Primary|Change in HAMD Score|Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.|Baseline,Week 8||||HAMD score||Standard Deviation|Mean
2838688|NCT00200902|Primary|Average Change in 3 Weeks of Participant Treatment Expectations|Patient Attitudes and Expectations Form PAEF) used for assessing expectation. The California Pharmacotherapy Alliance Scale (CALPAS), a measure associated with outcomes of antidepressant pharmacotherapy, was used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Scoring ranges from a minimum of 0 and a maximum of 120. The CALPAS score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A higher score indicates a positive outcome.|Averaged over 3 time points (Baseline, randomization, and end of lead-in)|88 participants who completed the first 3 time points in the study|||units on a scale||Standard Deviation|Mean
2838689|NCT00200902|Primary|Response as Assessed by Participants' Change in Depression Rating|Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.|Baseline, Week 8|Participants completing the Week 8 visit were included in the analysis (n=67)|||Participants|||Count of Participants
2838690|NCT00200850|Primary|Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment|Antigen challenge was performed using the antigen house dust mite. Increasing doses of antigen were inhaled and then lung function (using the procedure Spirometry, measuring Forced Expiatory Volume in the 1st second FEV1) was measured after each dose. The challenge was stopped once the lung function (FEV1) was dropped by 20% of percent predicted. The dose of antigen that caused a 20% drop in lung function is considered the bronchial threshold. The higher the dose of antigen that causes the drop in lung function, the higher tolerance a participant has of inhaling house dust mite. This dose was measure at baseline and then again after 12-18 months of treatment with sublingual house dust mite antigen.Cumulative breath units is the unit of measure to indicate how much antigen is tolerated before the FEV1 is dropped by 20%. Cumulative breath units is also known as breath units.|baseline and after 12-18 months treatment||||cumulative breath units||Standard Deviation|Mean
2838691|NCT00200785|Secondary|Electrical Impedance in Ohms|Electrical impedance (ohms) was measured using 0.5 mL of whole blood plus 0.5 mL saline in a Chronolog Whole Blood aggregometer. Ten mL of whole blood were collected and tested every week. There is no mathematical correlation between impedance (ohms) and percent aggregation.|4 weeks|"Nine persons participated in the high allicin test. Six of the same persons participated in the no allicin test."|||ohms||Standard Deviation|Mean
2838692|NCT00200785|Primary|Percent Platelet Aggregation|percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)|4 weeks||||percent platelet aggregation||Standard Deviation|Mean
2838693|NCT00200356|Secondary|Modified Rankin Scale Score|The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|6 months||||participants|||Number
2838694|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 3 Months|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.|3 months||||units on a scale||Standard Deviation|Mean
2838695|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 1 Month|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.|1 month||||units on a scale||Standard Deviation|Mean
2838696|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 14 Days|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.|14 days||||units on a scale||Standard Deviation|Mean
2838697|NCT00200356|Secondary|NIH Stroke Scale Score at 3 Months|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.|3 months||||participants|||Number
2838698|NCT00200356|Primary|the Rate of Patients With a Modified Rankin Scale Score of 0-1|The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months||||participants|||Number
2838699|NCT00200356|Secondary|NIH Stroke Scale Score at 1 Month|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.|1 month||||participants|||Number
2838700|NCT00200356|Secondary|NIH Stroke Scale Score at 14 Days|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.|14 days||||participants|||Number
2838701|NCT00200356|Secondary|Baseline NIH Stroke Scale Score|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).|Before treatment initiation||||scores on a scale||Standard Deviation|Mean
2838702|NCT00200356|Secondary|Barthel Index Score|"The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.~The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation."|3 months||||participants|||Number
2838703|NCT00200343|Secondary|Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|||Percentage of change||Full Range|Median
2838704|NCT00200343|Primary|Percentage Change of Alanine Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|||Percentage of change||Full Range|Median
2838705|NCT00200343|Secondary|Gamma-glutamyl Transpeptidase at Baseline||0 week||||IU/L||Standard Deviation|Mean
2838706|NCT00200343|Secondary|Percentage Change of Aspartate Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)||||Percentage of change||Full Range|Median
2838707|NCT00200343|Secondary|Aspartate Aminotransferase at Baseline||0 week||||IU/L||Standard Deviation|Mean
2838708|NCT00200343|Primary|Alanine Aminotransferase at Baseline||0 week|10 patients were excluded from analysis population due to luck of sufficient data.|||IU/L||Standard Deviation|Mean
2838709|NCT00200161|Secondary|To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.||through study completion, an average of 1 year|Data were not collected||||||
2838710|NCT00200161|Secondary|Prognostic Impact of Methylated MGMT Status.|MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.|through study completion, an average of 1 year|Data were not collected||||||
2838711|NCT00200161|Secondary|Progression Free Survival at 6 Months||6 months||||percentage of participants|||Number
2838713|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months."|Baseline and 12 months|All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.|||proportion of subjects||95% Confidence Interval|Mean
2838714|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
2838715|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
2838716|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
2838717|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.|||units on a scale||Standard Deviation|Mean
2838718|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.|||proportion of subjects||95% Confidence Interval|Mean
2838719|NCT00200057|Primary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week|"The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.|||proportion of subjects||95% Confidence Interval|Mean
2838720|NCT00199914|Secondary|Adverse Events||3 weeks|||||||
2838721|NCT00199914|Secondary|Patient's Satisfaction to the Treatment||3 weeks|||||||
2838722|NCT00199914|Secondary|Global Improvement||3 weeks|||||||
2838723|NCT00199914|Secondary|Gait Speed (Calculated From the Time Spending for 100-meter Walk)||3 weeks|||||||
2838758|NCT00198029|Primary|The Disabilities of the Arm, Shoulder and Hand Outcome Measure|The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.|26 weeks (6 months)||||units on a scale||Standard Deviation|Mean
2838759|NCT00197496|Secondary|Lower Extremity Functional Scale||discharge||||units on a scale||Standard Deviation|Mean
2838760|NCT00197496|Secondary|2 Minute Walk Test||discharge||||metres||Standard Deviation|Mean
2838724|NCT00199914|Primary|The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index|The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The total score ranges from 0 (best outcome possible) to 10 (worst outcome possible).|3 weeks|Statistical analyses to test the superiority were based on the intention-to-treat (ITT) population, and those chosen to demonstrate the equivalence were based on the per protocol population. The “worst –case-scenario” was applied to the dropouts in the ITT analyses.|||units on a scale||95% Confidence Interval|Mean
2838725|NCT00199875|Secondary|Number of Patients With Samples Collected for Evaluation of Human Antichimeric Antibody|"Blood samples were drawn for evaluation of the human antichimeric antibody (HACA) at screening, between Days 22 and 28, between Days 36 and 42, between Days 43 and 57 or at the end of study, and during long-term follow-up (approximately 12 weeks later). Serial dilutions were tested by the enzyme-linked immunosorbent assay (ELISA) using the double antibody sandwich technique and pretreatment serum as negative control."|Up to 6 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2838726|NCT00199875|Secondary|Number of Patients Who Met Protocol-Specified Criteria to Receive ^90-Y-DOTA-cG250 Following ^111In-DOTA-cG250 Administration|In order to receive the therapeutic ^90Y-DOTA-cG250 injection on Day 8, 9, or 10, patients must have demonstrated tumor targeting to lesions > 2 cm detected by CT scan and must not have exhibited the following characteristics following the nontherapeutic injection of ^111In-DOTA-cG250: excessive liver and/or spleen uptake; excessive uptake in the normal kidney; non-visualization of the cardiac blood pool in the first imaging set; whole body clearance half-life (t1/2) < 1.5 days; serum t1/2 < 2 days; rapid clearance of the radiopharmaceutical from the blood pool with prominent marrow uptake on the first image.|Up to 5 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2838727|NCT00199875|Primary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as follows for the purposes of dose escalation: Grade 4 hematopoietic toxicity in excess of 5 days or Grade 3 or greater nonhematopoietic toxicity.|Continuously for up to 5 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2838728|NCT00199381|Primary|Safety as Measured by Adverse Events|Investigation of the long-term tolerability and safety of istradefylline|Every 2 months up to 32 months|Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set.|||participants|||Number
2838729|NCT00198822|Secondary|Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gestation)||||micromoles per liter||Standard Deviation|Mean
2838730|NCT00198822|Primary|All-cause, Pregnancy-related Mortality|Mortality evaluated on intent-to-treat basis|Deaths during pregnancy through 12 weeks postpartum|As the study ended on the advice of the Data and Safety Monitoring Board, based on evidence of no difference, all enrolled women who had a chance of being followed through 84 days after the end of their pregnancy were included in the trial. The cohort included pregnancies identified between August 17, 2001 and January 5, 2006.|||Participants|||Number
2838731|NCT00198822|Secondary|Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gesatation)||||Plasma beta-carotene micromoles / liter||Standard Deviation|Mean
2838732|NCT00198822|Secondary|Infant Morbidity Through 3 Months of Age||within 24 weeks after birth|||||||
2838733|NCT00198822|Secondary|Fetal Growth and Postnatal Infant Growth Through Three Months of Age||through the 1st 12 weeks after birth|||||||
2838734|NCT00198822|Secondary|Gestational Age at Birth||within 24 weeks after birth|||||||
2838735|NCT00198822|Secondary|Maternal Morbidity, Including Obstetric Complications||through the 1st 24 weeks following termination of pregnancy|||||||
2838736|NCT00198822|Secondary|All-cause 3-month Infant Mortality||Deaths through the 1st 12 weeks of life|Mortality evaluated on intent-to-treat basis|||participants|||Number
2838737|NCT00198133|Secondary|Grade 3/4 Treatment Related Adverse Events|To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).|Up to 3 years|All patients enrolled and received treatment|||participants|||Number
2838738|NCT00198133|Secondary|Duration of Remission|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|Time from the date of remission until progression or death, assessed up to 3 years|All patients with at least one post baseline measurement who had a response of CR or PR|||months||95% Confidence Interval|Median
2838739|NCT00198133|Primary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.|Up to 3 years|All patients with at least one post baseline measurement. (26 evaluable – 15 T and 11 TC patients)|||percentage of participants||95% Confidence Interval|Number
2838761|NCT00197496|Secondary|Falls Self Efficacy||discharge||||units on a scale||Standard Deviation|Mean
2838762|NCT00197496|Secondary|Timed up and Go||discharge||||seconds||Standard Deviation|Mean
2838740|NCT00198107|Secondary|Mean Social Reciprocity Scale (SRS) Total Score, Week 8|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total score results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates.|Week 8|All randomized study participants. For 9 participants who exited the double-blind phase prior to week 8 but completed an exit interview (8 assigned to placebo and 1 to aripiprazole), week 8 scores were imputed using a last observation carried forward approach.|||units on a scale||95% Confidence Interval|Mean
2838741|NCT00198107|Secondary|Mean Autism Diagnostic Observation Schedule (ADOS) Social Affect and Restricted and Repetitive Behaviors Total Score, Week 8|Autism Diagnostic Observation Scale (ADOS) (Lord), Modules 1-3 yields scores in 2 scales: Social Affect and Restricted and Repetitive Behavior. The ADOS has been repeatedly evaluated as a diagnostic measure, it has also been used as an outcome measure of autism severity (Aldred et al., 2004; Gutstein, 2007; Owly et al, 2001, Green et al, 2010). For modules 1-3, scores ranging from 0-2 on 14 items are summed to arrive at the Social Affect and Restricted and Repetitive Behavior Total Score, which ranges from 0 to 28. Higher scores indicate greater autism severity. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates|Week 8|All randomized study participants. For 9 participants who exited the double-blind phase prior to week 8 but completed an exit interview (8 assigned to placebo and 1 to aripiprazole), week 8 scores were imputed using a last observation carried forward approach.|||units on a scale||95% Confidence Interval|Mean
2838742|NCT00198107|Secondary|Mean Vineland Maladaptive Behavior Subscales Total Score, Week 8|The Vineland Adaptive Behavior Scales, (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. An increase in standard scores from Baseline to the Final Visit indicates improvement. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates.|Week 8|All randomized study participants. For 7 participants who exited the double-blind phase prior to week 8 but completed an exit interview (all assigned to placebo), week 8 scores were imputed using a last observation carried forward approach.|||units on a scale||95% Confidence Interval|Mean
2838743|NCT00198107|Secondary|Mean Post-baseline Score on a Modified Version of the Compulsion Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CYBOCS- PDD is a semi-structured clinician-rated scale designed to rate the current severity of repetitive behavior in children with idiopathic autism spectrum disorders. Once the current repetitive behaviors are identified, they are rated on: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored from 0 (least symptomatic) to 4 (most symptomatic), yielding a Total score from 0 to 20. Higher scores indicate higher severity. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.|Weeks 2, 4, 6 and 8|All randomized study participants with at least one post-baseline CY-BOCS score. Two participants assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2838744|NCT00198107|Secondary|Mean Post-baseline Aberrant Behavior Checklist Stereotypy Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicates greater severity. Seven item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total stereotypy scale score ranging from 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6, and 8|All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2838745|NCT00198107|Secondary|Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicates greater severity. Sixteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total social withdrawal scale score ranging from 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6, and 8|All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2838763|NCT00197496|Primary|Feasibility - # With > or = 60% Compliance, # Agreeing to Participate, # Returning for 3 Month Follow-up|Compliance to BWSTT only,|3 months||||Participants|||Count of Participants
2838764|NCT00197392|Secondary|Number of Catheter Insertion Attempts|Number of insertions needed to place catheter|Implantation of subject||||insertions|||Number
2838765|NCT00197392|Secondary|Length of Catheter Tunneling Into the Brain|Length of tunneling of EVD catheter in the brain for each analysis population.|Implant of subject||||cm||Standard Deviation|Mean
2838746|NCT00198107|Secondary|Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Four item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total inappropriate speech scale score ranging from 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6, and 8|All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2838747|NCT00198107|Secondary|Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity, impulsiveness, inattention and noncompliance. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscale is that higher scores, indicate greater severity. Sixteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total score ranging from 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2838748|NCT00198107|Primary|Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)|Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds were estimated using a repeated measures logistic regression model with treatment group, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average log odds across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.|Weeks 1, 2, 3, 4, 6 and 8|All randomized study participants with at least one post-baseline CGI-I rating. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline ratings.|||odds||95% Confidence Interval|Number
2838749|NCT00198107|Primary|Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Fifteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total irritability scale store ranging from 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting|Weeks 1, 2, 3, 4, 6, and 8|All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.|||units on a scale||95% Confidence Interval|Mean
2838750|NCT00198081|Primary|Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
2838751|NCT00198081|Primary|Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
2838752|NCT00198081|Primary|Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
2838753|NCT00198081|Secondary|Number of Participants With Clinical Changes in IPMN Progression.|Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.|Baseline, 6 months, 1 year|Data never collected for surgical arm; medical arm of study never initiated.||||||
2838754|NCT00198081|Primary|Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months||||pg/ml|||Number
2838755|NCT00198042|Other Pre-specified|Bone Tunnel Cross Sectional Area||2 years|||||||
2838756|NCT00198042|Primary|Bone Tunnel Diameter|Bone tunnel diameter measured on MRI|2 years|MRI measurement of tunnel dimensions.|||mm||Standard Deviation|Mean
2838757|NCT00198029|Secondary|Visual Analog Scale for Pain|The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.|26 weeks (6 months)||||mm||Standard Deviation|Mean
2838772|NCT00197392|Secondary|Device Related Adverse Events|Number of Device Related Adverse Events|Implanted subjects to time of explant|There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.|||events|||Number
2838773|NCT00197392|Secondary|Intraluminal Colonization on Catheters|Number of catheters with Bacterial colonization verified using fluorescence.|Implant of subjects to post implant||||catheters|||Number
2838774|NCT00197392|Secondary|Class of Bacterial Agent Causing Proven Infection|Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD|Implantation of subject to post implant|All subjects included in the MITT, Evaluable and Per-Protocol population.|||participants|||Number
2838775|NCT00197392|Secondary|Days to Proven Infection|Number of days to proven infection.|Implantation of EVD System to explant of EVD catheter, an average of ten days||||Days||Standard Deviation|Mean
2838776|NCT00197392|Primary|Number of Infections|The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).|Duration of implanted EVD system to 2 week post implant||||Infections|||Number
2838777|NCT00197236|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events|Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.|Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.|The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase.|||Participants|||Count of Participants
2838778|NCT00197236|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|31-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort|||Participants|||Count of Participants
2838779|NCT00197236|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2838780|NCT00197236|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2838781|NCT00197236|Secondary|Number of Subjects With Vaccine Response to Havrix™.|Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.|31 days following the second dose|Analysis was performed on the According-to-Protocol cohort for immunogenicity|||Participants|||Count of Participants
2838782|NCT00197236|Secondary|Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838783|NCT00197236|Secondary|Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838784|NCT00197236|Secondary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.|||Participants|||Count of Participants
2838785|NCT00197236|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)|Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||Participants|||Count of Participants
2838786|NCT00197236|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as microgram/milliliter (µg/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||µg/mL||95% Confidence Interval|Geometric Mean
2838787|NCT00197236|Secondary|Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as International Units per milliliter (IU/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||IU/mL||95% Confidence Interval|Geometric Mean
2838851|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2838788|NCT00197236|Primary|Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)|Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||Participants|||Count of Participants
2838789|NCT00197236|Primary|Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects|Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.|||Participants|||Count of Participants
2838790|NCT00197236|Primary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
2838791|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|At least one month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
2838792|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day follow-up period after additional vaccination.|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
2838793|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.~Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination"|During the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
2838794|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.~Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful"|during the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||Participants|||Count of Participants
2838795|NCT00197184|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From last study visit of the primary study up to Year 5 long term follow-up|The analysis was performed on the Long term Total vaccinated cohort wich included all subjects who returned at a specified follow-up study|||Participants|||Count of Participants
2838796|NCT00197184|Primary|Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).|Before and One month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838797|NCT00197184|Primary|Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.|Before and one month after additional vaccination|None of the subjects became seronegative for anti-HAV antibodies during the Year 2 to Year 5 long term follow-up. Hence none of the subjects received an additional Havrix dose.||||||
2838798|NCT00197184|Primary|Anti-hepatitis B (HBs) Antibody Concentrations|Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.|||mIU/mL||95% Confidence Interval|Geometric Mean
2839129|NCT00195442|Primary|Mean Number of Bleeding-related Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||days per year||Standard Deviation|Mean
2838799|NCT00197184|Primary|Anti-hepatitis A (HAV) Antibody Concentrations|Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838800|NCT00197145|Secondary|Number of Participants With the Impact on Health Related Quality of Life Measured by Euro Quality of Life (Qol) Questionnaire During the Randomized Treatment Phase|The EuroQol is a standardized instrument for use as a measure of health related quality of life. It consists of two pages comprising the EuroQoL 5 Dimension 5 level (EQ-5D5) descriptive system and the EQ visual analogue scale (VAS). The EQ-5D5 comprises of five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety). Each dimension comprises five levels of response (no problems, mild problems, moderate problems, moderate to extreme problems, and extreme problems). The EQ VAS records the respondents self-rated health status on a vertical graduated (0 to 100) VAS. Higher score represented greater severity of diseases.|Up to Week 48|ITT Population. Data for this outcome measure were not collected due to early termination of the study.||||||
2838801|NCT00197145|Secondary|Number of Participants Who Were Bothered by Each of Several Specific Symptoms Evaluated Using the HIV Symptom Index Questionnaire During the Randomized Treatment Phase|The HIV Symptom Index Questionnaire was planned to be used to evaluate how bothersome certain symptoms were during the conduct of this clinical study. The participant self-report instrument had 20 items, each of which asked about a specific symptom or group of related symptoms that participants might have had during the past 4 weeks and the degree to which the participant is bothered by the symptom. The symptom index comprised 32 common and HIV-specific symptoms scored in terms of presence/absence (1, 0) and severity on a 4-point scale (0 = not at all to 3 =quite a bit). Higher score represented greater severity of symptoms.|Upto Week 48|ITT Population. Data for this outcome measure were not collected due to early termination of the study.||||||
2838802|NCT00197145|Secondary|Investigational Product Adherence Measured by Pill Counts|Adherence to investigational product was planned to be evaluated using pill counts of unused investigational product (blinded GW873140 or placebo, open-label GW873140 for open label phase). This assessment was planned to be conducted at each time the participant received a new (refill) supply of study medication.|Up to Week 48 of Randomized Treatment phase and up to Switch + 24 Weeks of the Open Labeled phase|ITT Population. Data for this outcome measure were not collected due to early termination of the study.||||||
2838803|NCT00197145|Secondary|Plasma GW873140 400 mg BID PK Parameter of Concentration at End of Dosing Interval (Trough Concentration [Cτ]) During the Randomized Treatment Phase|Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|PK Population. Data were not collected for this outcome measure due to early termination of the study.||||||
2838804|NCT00197145|Secondary|Plasma GW873140 400 mg BID PK Parameter of Time of Maximum Observed Plasma Concentration (Tmax) During the Randomized Treatment Phase|Tmax is defined as the time at which Cmax is observed, determined directly from the raw concentration-time data. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|PK Population. Data were not collected for this outcome measure due to early termination of the study.||||||
2838805|NCT00197145|Secondary|Plasma GW873140 400 mg BID PK Parameter of Maximum Observed Plasma Concentration (Cmax) During the Randomized Treatment Phase|Cmax is defined as the first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|PK Population. Data were not collected for this outcome measure due to early termination of the study.||||||
2838815|NCT00197145|Secondary|Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Femtoliter (FL)||Standard Deviation|Mean
2838816|NCT00197145|Secondary|Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Giga cells (GI)/L||Standard Deviation|Mean
2838806|NCT00197145|Secondary|Plasma GW873140 400 mg BID Pharmacokinetic (PK) Parameter of Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length (Tau) (AUC [0-tau]) During the Randomized Treatment Phase|AUC (0- tau) GW873140 was defined as the area under the plasma concentration-time curve from time 0 to tau. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24. It was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)|The PK Population was defined as all participants who received GW873140 and underwent plasma PK sampling during the study. Participants for whom plasma a PK sample was obtained and assayed were planned to be included in analyses of the PK population. Data were not collected for this outcome measure due to early termination of the study.||||||
2838807|NCT00197145|Secondary|Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline|The IC50 is a measure of the effectiveness of a substance in inhibiting a specific biological or biochemical function. IC50 was collected for abacavir (ABC), atazanavir (ATV), delavirdine (DLV), didanosine (DDI), efavirenz (EFV), emtricitabine, enfuvirtide , fosamprenavir (AMP), GW873140 (APL), indinavir (IDV), indinavir rooted with ritonavir (IDV/r), lamivudine, lopinavir rooted with ritonavir (LPV/r), nelfinavir (NFV), nevirapine (NVP), ritonavir (RTV), saquinavir (SQV), stavudine, tenofovir (TFV), tipranavir rooted with ritonavir (TPV/r), zidovudine (ZDV). Data is categorized for number of participants with each IC50 concentration of the individual drugs at Baseline (Day 1).|Baseline (Day 1)|ITT Population.|||Participants|||Count of Participants
2838808|NCT00197145|Secondary|Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs|Assessment for the development of antiretroviral resistance was performed at each visit up to Follow-up. The genotypic analysis of viral resistance associated mutations was done using protease and reverse transcriptase enzymes. The number of participants with treatment emergent changes in reverse transcriptase and protease genotypic mutations were reported.|Up to Follow-up (Week 52)|Virologic Failure Population was defined as the number of participants with protocol defined virologic failure criteria.|||Participants|||Count of Participants
2838809|NCT00197145|Secondary|Time to Centres for Disease Control and Prevention (CDC) Class C Acquired Immune Deficiency Syndrome (AIDS)-Defining Event or Death|The time to CDC class C AIDS-defining event or death was planned to be assessed as per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|Up to Week 12 Follow-up of the Randomized phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase|ITT Population. Data were not collected for this outcome measure due to early termination of the study.||||||
2838810|NCT00197145|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase|The CD4 cell count is an indication of the strength of the immune system. The assessment of CD4 cell count was done by flow cytometry. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12, 24 and 40) values.|Baseline (Day 1), Week 12, Week 24 and Week 40|ITT Population. Only those participants available at the specified time points were analyzed.|||Cells/Cubic millimeter (mm^3)||Standard Deviation|Mean
2838811|NCT00197145|Secondary|Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase|12-lead ECG assessments were obtained at Day 1 (triplicate measurements), Week 4 and Week 24. The assessments were done using an ECG machine that automatically measured RR, PR, QRS, uncorrected QT, QTc (Bazette) and QTc (Fridericia) intervals. Baseline was defined as the mean of the triplicate assessment done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 4 and Week 24) values.|Baseline (Day 1), Week 4 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
2838812|NCT00197145|Secondary|Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase|12-lead ECG assessments were obtained at Day 1 (triplicate measurements), Week 4 and Week 24. The assessments were done using an ECG machine that automatically calculated the heart rate. Baseline was defined as the mean of the triplicate assessment done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 4 and 24) values.|Baseline (Day 1), Week 4 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Beats per minute (Bpm)||Standard Deviation|Mean
2838813|NCT00197145|Secondary|Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2838814|NCT00197145|Secondary|Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of red blood cells||Standard Deviation|Mean
2838817|NCT00197145|Secondary|Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||U/L||Standard Deviation|Mean
2838818|NCT00197145|Secondary|Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed|||Gram (g)/L||Standard Deviation|Mean
2838819|NCT00197145|Secondary|Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Micromole (UMOL)/L||Standard Deviation|Mean
2838820|NCT00197145|Secondary|Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimole (MMOL)/L||Standard Deviation|Mean
2838821|NCT00197145|Secondary|Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase|Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.|Baseline (Day 1), Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||International unit per liter (IU/L)||Standard Deviation|Mean
2838822|NCT00197145|Secondary|Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline|The participants with treatment emergent toxicities of laboratory abnormalities for chemistry data is reported . Participants with toxicities were categorized according to the division of AIDS (DAIDS) toxicity grading scale. Scale ranges from grade 1(mild)=symptoms causing no or minimal interference with usual social & functional activities, grade 2 (moderate)=symptoms causing greater than minimal interference with usual social & functional activities, grade 3 (severe)=symptoms causing inability to perform usual social & functional activities and grade 4 (potentially life threatening)=symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Scale ranges from 1-4, where higher grade reflects greater severity of symptoms. Baseline was defined as assessments done at Day 1. Only those parameters for which at least one value of toxicity grade was reported are summarized.|Up to Week 40|ITT Population.|||Participants|||Count of Participants
2838823|NCT00197145|Secondary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, hypersensitivity reaction to abacavir. AEs were classified as potentially drug-related, based on the investigator's judgment.|Up to Follow-up (Week 52)|ITT Population.|||Participants|||Count of Participants
2838824|NCT00197145|Secondary|Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48|Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by PCR analysis. Data is reported for number of participants with plasma HIV-1 RNA <50 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.|Week 24|ITT Population. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.|||Participants|||Count of Participants
2838825|NCT00197145|Primary|Number of Participants With >= 1.0 log10 Copies/mL Decrease in Plasma HIV-1 RNA From Baseline Over Time|The plasma HIV-1 RNA polymerase chain reaction (PCR) assessments were planned at pre-Baseline (between 1 and 14 days prior to Day 1), up to Week 12 Follow- up of the Randomized Phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase, however the study was early terminated at Week 40. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values.|Day 1 up to Week 12 Follow-up of the Randomized Treatment phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase|ITT Population. Data were not collected for this outcome measure due to early termination of the study.||||||
2838826|NCT00197145|Primary|Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period|The area under the plasma HIV-1 RNA curve (AUC) was computed using the trapezoidal rule for all assessments (scheduled and unscheduled) at their actual time points. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Participants without a Baseline assessment was removed from the analysis. The AAUCMB was computed by the AUC divided by the duration of the profile (i.e., the number of days on randomized therapy) minus the Baseline measurement. Data is reported up to Week 40 only due to early termination of the study.|Up to Week 40|ITT Population. Only those participants available at the specified time points were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2839219|NCT00194116|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS total scores range from 0-60, where higher scores are indicative of more depression.|Acute phase (week0-week6)||||units on a scale||Standard Error|Least Squares Mean
2838827|NCT00197145|Primary|Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48|Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by polymerase chain reaction (PCR) analysis. Data is reported for number of participants with plasma HIV-1 RNA <400 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.|Week 24|Intent to Treat (ITT) Population comprised of all participants randomized with evidence of receiving at least one dose of study medication. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.|||Participants|||Count of Participants
2838828|NCT00197119|Primary|Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Year 6 through to Year 10||||subjects|||Number
2838829|NCT00197119|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.|||subjects|||Number
2838830|NCT00197119|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value|Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.|||subjects|||Number
2838831|NCT00197106|Secondary|Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||||||
2838832|NCT00197106|Secondary|Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||||||
2838833|NCT00197106|Secondary|Cumulative Number of Symptom-free Weeks Until the End of Treatment|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||||||
2838834|NCT00197106|Secondary|Frequency of Asthma Exacerbations (Discriminated on Severity)|The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.|26 weeks|||||||
2838835|NCT00197106|Secondary|Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)|Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.|26 weeks|||||||
2838836|NCT00197106|Secondary|Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres|Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.|26 weeks|||||||
2838837|NCT00197106|Secondary|Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26|PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. From this population, only participants who had measurements at both baseline and Week 26 have been used for analysis.|||ratio||95% Confidence Interval|Log Mean
2838838|NCT00197106|Secondary|Number of Asthma Exacerbations Per Treatment Group at Week 26|An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.|Week 26|Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication)|||number of exacerbations|||Number
2838839|NCT00197106|Secondary|Percent Change From Baseline in RINT Measurements at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.|Baseline and Week 26|PP Population: Intent-to-Treat (ITT) Population participants who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26). For some participants, the data for the RINT measurement are missing, either at Baseline or at Week 26. As a result, fewer subjects have been included in the analysis.|||percent|||Number
2838840|NCT00197106|Secondary|Geometric Means of Nitric Oxide (NO) at Week 26|Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26)|||parts per billion||Full Range|Geometric Mean
2838852|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2838841|NCT00197106|Secondary|Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. For some participants, the data for the MEF 50 measurements are missing, resulting in a smaller number of participants analyzed.|||liters/second||Standard Deviation|Mean
2838842|NCT00197106|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.|||liters||Standard Deviation|Mean
2838843|NCT00197106|Secondary|Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.|||percent predicted change||Standard Deviation|Mean
2838844|NCT00197106|Secondary|Percentage of Symptom-free Days During the Entire Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary|Baseline to Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations|||percentage of days||Standard Deviation|Mean
2838845|NCT00197106|Primary|Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.|Last 10 weeks of the treatment period (Weeks 16-26)|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations|||percentage of days||Standard Deviation|Mean
2838846|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2838847|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2838848|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2838849|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2838850|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.|||subjects|||Number
2839220|NCT00194077|Primary|Time in Weeks to Discontinuation|Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.|up to 72 weeks||||time in weeks to discontinuation||95% Confidence Interval|Mean
2838853|NCT00197028|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.|||Parasites per µL||Full Range|Mean
2838854|NCT00197028|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum)|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.|||subjects|||Number
2838855|NCT00197028|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.|||n/PYAR|||Number
2838856|NCT00197028|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2838857|NCT00197028|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 15 EL.U/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2838858|NCT00197028|Secondary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2838859|NCT00197028|Secondary|Concentrations of Antibodies Against Anti-diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2838860|NCT00197028|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL.|Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2838861|NCT00197028|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL.|Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838862|NCT00197028|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|Throughout the entire study period (from Month 0 to Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||subjects|||Number
2838863|NCT00197028|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||subjects|||Number
2838864|NCT00197015|Secondary|Number of Subjects Reporting Medically Significant Events|Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).|||Participants|||Count of Participants
2838865|NCT00197015|Secondary|Number of Subjects Reporting New Chronic Illnesses|New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).|||Participants|||Count of Participants
2838866|NCT00197015|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
2838867|NCT00197015|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|During the 31-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
2838868|NCT00197015|Secondary|Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events|Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.|During the 43-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects from MMR+V→HAV and HAV+MMR+V groups.|||Participants|||Count of Participants
2838869|NCT00197015|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.|||Participants|||Count of Participants
2838870|NCT00197015|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, rash (local), redness and swelling.|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.|||Participants|||Count of Participants
2838871|NCT00197015|Secondary|Number of Subjects With Vaccine Response to Havrix®|Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||Participants|||Count of Participants
2838872|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.|||Participants|||Count of Participants
2838873|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group|Concentrations are given as geometric mean concentrations (GMCs).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2838874|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.|||Participants|||Count of Participants
2838875|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups|Concentrations are given as geometric mean concentrations (GMCs).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
2839023|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 100 (CR-100)|A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
2838876|NCT00197015|Secondary|Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups|Titers are given as geometric mean titers (GMTs).|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.|||titers||95% Confidence Interval|Geometric Mean
2838877|NCT00197015|Primary|Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).|42 days following administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.|||Participants|||Count of Participants
2838878|NCT00197015|Primary|Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.|||Participants|||Count of Participants
2838879|NCT00197015|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.|||Participants|||Count of Participants
2838880|NCT00197015|Primary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.|Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V Groups.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838881|NCT00197002|Secondary|Number of Subjects With SAEs, NCIs and MSEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose)|The analysis was performed on the ESFU cohort, which included all vaccinated subjects for whom safety data were available during the extended safety follow-up period (from Day 30 up to 6 months after last vaccine dose).|||Participants|||Count of Participants
2838882|NCT00197002|Secondary|Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. NCIs include autoimmune disorders, asthma, type I diabetes, allergies. MSEs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
2838883|NCT00197002|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Day 0-30) follow-up period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
2838884|NCT00197002|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2839017|NCT00195715|Secondary|Percentage of Subjects With Serious Infection|Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.|Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2838885|NCT00197002|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2838886|NCT00197002|Secondary|Number of Subjects With Vaccine Response to Anti-HAV Antibodies|"The vaccine response was defined as:~a detectable anti-HAV antibody concentration one month after Dose 2 in subjects who were initially seronegative (antibody concentrations < 15 mIU/mL for anti-HAV); or~a 2-fold increase above the pre-vaccination concentration one month after Dose 2 in subjects who were initially seropositive (antibody concentrations ≥ 15 mIU/mL for anti-HAV)."|One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
2838887|NCT00197002|Secondary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).|At one month after Dose 2 of Havrix® vaccine (Month 8-11)|The analysis was performed on the ATP Cohort for Immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838888|NCT00197002|Secondary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.|At one month after Dose 2 of Havrix® vaccine (Month 8-11)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
2838889|NCT00197002|Secondary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli international units per milliliter (mIU/mL).|At one month after Dose 1 of Havrix® vaccine (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838890|NCT00197002|Secondary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 mIU/mL in the sera of subjects seronegative before vaccination.|At one month after Dose 1 of Havrix® vaccine (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
2838891|NCT00197002|Secondary|Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|The immune response was defined, with respect to anti-pneumococcal response rates, as an antibody concentration equal to or above (≥) 0.05 μg/mL.|At one month after Prevnar™ vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
2838892|NCT00197002|Secondary|Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations|Antibody concentrations against pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL).|At one month after Prevnar™ vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||μg/mL||95% Confidence Interval|Geometric Mean
2838893|NCT00197002|Primary|Concentrations for Anti-HAV Antibodies|Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At one month after Dose 2 of Havrix® vaccine (Month 7-10)|The analysis was performed on the ATP cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
2838894|NCT00197002|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies|Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.|At one month after Dose 2 of Havrix® vaccine (Month 7-10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all vaccinated subjects for whom immunogenicity data were available and who complied with the eligibility criteria as defined in the protocol.|||Participants|||Count of Participants
2838895|NCT00196976|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.|||Participants|||Count of Participants
2838896|NCT00196976|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the primary vaccination study (from Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2839018|NCT00195715|Secondary|Percentage of Subjects With Infection||Up to 262 weeks of adalimumab treatment|Safety population, defined as all subjects who received at least 1 dose of study drug|||Percentage of participants|||Number
2839221|NCT00194025|Secondary|Tolerability as Measured by Mean Serum Level at Study Endpoint||Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||ug/mL||Standard Deviation|Mean
2838897|NCT00196976|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after the booster vaccination|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.|||Participants|||Count of Participants
2838898|NCT00196976|Secondary|Number of Subjects With Any Unsolicited AEs During the Primary Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2838899|NCT00196976|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after the primary meningococcal vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2838900|NCT00196976|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period following booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.|||Participants|||Count of Participants
2838901|NCT00196976|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period following booster dose|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.|||Participants|||Count of Participants
2838902|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||μg/mL||95% Confidence Interval|Geometric Mean
2838903|NCT00196976|Secondary|Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||Participants|||Count of Participants
2838904|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||Titers||95% Confidence Interval|Geometric Mean
2838905|NCT00196976|Secondary|Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups|A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.|Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.|||Participants|||Count of Participants
2838915|NCT00196976|Secondary|Number of Toddlers With Any Solicited Local Symptoms|The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
2838906|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||µg/mL||95% Confidence Interval|Geometric Mean
2838907|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|At one month (M1) and 12 months (M12) post primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
2838908|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides|A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
2838909|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Titers||95% Confidence Interval|Geometric Mean
2838910|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Serogroups|A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
2838911|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Serogroups|A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.|At one month (M1) and 12 months (M12) post-primary vaccination|The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.|||Participants|||Count of Participants
2838912|NCT00196976|Secondary|Number of Children With Any Solicited General Symptoms|The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
2838913|NCT00196976|Secondary|Number of Toddlers With Any Solicited General Symptoms|The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
2838914|NCT00196976|Secondary|Number of Children With Any Solicited Local Symptoms|The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.|||Participants|||Count of Participants
2838916|NCT00196976|Secondary|Antibody Concentrations Against Tetanus (Anti-T)|Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2838917|NCT00196976|Secondary|Number of Seropositive Subjects for Anti-tetanus (Anti-T)|A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2838918|NCT00196976|Secondary|Antibody Concentrations Against Different Meningococcal Polysaccharides|The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2838919|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides|A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2838920|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides|A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2838921|NCT00196976|Secondary|Antibody Titers Against Different Meningococcal Serogroups|Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2838922|NCT00196976|Secondary|Number of Seropositive Subjects for Different Anti-meningococcal Serogroups|A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.|Prior to (Month 0) and one month after (Month 1) after the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2838923|NCT00196976|Secondary|Number of Seroprotected Subjects Against Different Meningococcal Serogroups|A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.|Prior to (Month 0) and one month after (Month 1) the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2838924|NCT00196976|Primary|Number of Subjects With an Immune Response to Different Meningococcal Serogroups|A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.|One month after the first vaccine dose (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2838925|NCT00196937|Secondary|Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies|Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown.|During the entire study period (from Day 0 up to Month 48)|The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented and for whom data were available.|||Participants|||Count of Participants
2838926|NCT00196937|Secondary|Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects|Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA.|At Months 18 and 24|The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study.|||Participants|||Count of Participants
2838927|NCT00196937|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples|Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA.|At Months 18 and 24|The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2839222|NCT00194025|Secondary|Tolerability as Assessed by Weight Change||Baseline to 12 weeks|All available data was used implementing LOCF.|||kilograms||Standard Deviation|Mean
2838928|NCT00196937|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.|During the entire study period (from Day 0 up to Month 48)|The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.|||Participants|||Count of Participants
2838929|NCT00196937|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)|NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.|During the entire study period (from Day 0 up to Month 48)|The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.|||Participants|||Count of Participants
2838930|NCT00196937|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above.|During the entire study period (from Day 0 up to Month 48)|The analysis was based on the TVC (up to Month 7), which included all subjects with at least one study vaccine administered and on the Extended Follow-up (EFU) Vaccinated cohort (Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.|||Participants|||Count of Participants
2838931|NCT00196937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and for whom data were available.|||Participants|||Count of Participants
2838932|NCT00196937|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.|During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available.|||Participants|||Count of Participants
2838933|NCT00196937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses|The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available.|||Participants|||Count of Participants
2838934|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group.|At Month 2 and Month 12|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.|||Participants|||Count of Participants
2838935|NCT00196937|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12|Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL. Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol.|At PRE and Months 2, 7 and 12|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2838936|NCT00196937|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1.|At Month 7|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.|||Participants|||Count of Participants
2839019|NCT00195715|Secondary|Percentage of Subjects With Fistula Remission|Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.|Week 156|Intent-to-treat, Subjects with fistulas present at baseline of the preceding study, Observed Cases|||Percentage of participants|||Number
2838937|NCT00196937|Primary|Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48|Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL. Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol.|At Months 18, 24, 36 and 48|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2838938|NCT00196937|Primary|Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age|Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol.|At Month 7|The analysis was based the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.|||Participants|||Count of Participants
2838939|NCT00196716|Secondary|Urine Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24 and Week 96. Urine GL-3 is often elevated in the urine of patients diagnosed with Fabry disease. This outcome measure evaluated the mean urine GL-3 in first morning void urine for all patients to see if it decreased while on Fabrazyme. Normal Urine GL-3 threshold was < 8.8 μg/mg.|Throughout study, 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||μg/mg||Standard Deviation|Mean
2838940|NCT00196716|Secondary|Plasma Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24, Week 48, Week 72 and Week 96. Plasma GL-3 is often elevated in the plasma of patients diagnosed with Fabry disease. This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level was <= 7.03 µg/mL.|Throughout study; 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||μg/mL||Standard Deviation|Mean
2838941|NCT00196716|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Evaluated at Baseline, Week 24 and Week 96. eGFR is an estimation of the glomerular filtration rate of the kidneys (how much blood the kidneys are filtering). For this study, normal eGFR was defined as greater than 90 mL/min/1.73 m2|Throughout study; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||ml/min/1.73 m2||Standard Deviation|Mean
2838942|NCT00196716|Secondary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 24, Week 48, Week 72, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study ; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||Participants|||Number
2838943|NCT00196716|Primary|Globotriaosylceramide (GL-3) Clearance in Kidney Interstitial Capillary Endothelium|Kidney biopsies were taken at Baseline, Week 24, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study; 96 weeks|Intent-to-Treat (ITT) Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.|||Participants|||Number
2838944|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.~The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.~Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.~Three denominators are reported;~excluding cycles where other birth control methods (BCMs) was used~all complete cycles~compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.|||pregnancies per 100 woman years exposure|||Number
2838945|NCT00196326|Secondary|Participants With Treatment-Emergent Adverse Events|Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.|Day 1 up to one year|The safety cohort consisted of all patient who took at least one dose of study medication|||participants|||Number
2838960|NCT00195819|Secondary|Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Weeks 12 and 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.|||score on a scale||Standard Error|Mean
2838946|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.~The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.~Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.~Three denominators are reported;~excluding cycles where other birth control methods (BCMs) was used~all complete cycles~compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.|||pregnancies per 100 woman years exposure|||Number
2838947|NCT00196313|Secondary|Analgesic Use|number of days analgesic (pain) medication was used over the 13 week treatment period|13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||Days Analgesic was used over 13 weeks||Standard Deviation|Mean
2838948|NCT00196313|Secondary|Number of Days Missed From School/Work or Other Activities||13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||Days||Standard Deviation|Mean
2838949|NCT00196313|Secondary|Incidence of Menstrual Bleeding and /or Spotting||Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||Days of bleeding/spotting over 13 weeks||Standard Deviation|Mean
2838950|NCT00196313|Secondary|Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain|"Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.~The severity of the pain was assessed using a 4-points scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe)"|Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||units on a scale||Standard Error|Least Squares Mean
2838951|NCT00196313|Primary|Mean Change in Average Severity for Abdominal/Pelvic Pain|"Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe)"|Baseline to end of 13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.|||units on a scale||Standard Error|Least Squares Mean
2838952|NCT00196196|Secondary|Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds|Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = >20 mmH20)|Day 1||||Percentage of agreement|||Number
2838953|NCT00196196|Primary|"Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading"|"Up to 5 attempts to achieve Adjustment Complete using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered consensus X-ray. All participants included achieved Adjustment Complete and a consensus X-ray reading."|Day 1||||Percentage of participants|||Number
2838954|NCT00196105|Primary|Time to Death|Overall Survival|up to 32 months||||Days||Inter-Quartile Range|Median
2838955|NCT00196105|Primary|Number of Deaths||up to 32 months||||Participants|||Number
2838956|NCT00196105|Primary|Number of Days to Occlusion||up to 32 months||||Days||Full Range|Median
2838957|NCT00196105|Primary|Closure or Blockage of the Stent (Occlusion)|"Biliary stents may become closed or blocked. This is also termed Occlusion. Data for this outcome measure involve stent occlusions that required re-intervention."|up to 32 months||||Stent Occlusions|||Number
2838958|NCT00196105|Primary|Patency|Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).|up to 32 months||||Days||Full Range|Median
2838959|NCT00195819|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Baseline and Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.|||score on a scale||Standard Error|Mean
2839020|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free CR-100|Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with corticosteroid use at baseline of preceding study, Observed Cases|||Percentage of participants|||Number
2838961|NCT00195819|Secondary|Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Week 12 and Week 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.|||score on a scale||Standard Error|Mean
2838962|NCT00195819|Secondary|Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage degradation and bone resorption were assessed by evaluating changes in NTx. A decrease in NTx represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||NM BCE||Standard Deviation|Mean
2838963|NCT00195819|Secondary|Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in CTX-II. A decrease in CTX-II represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||ng/mmolcr||Standard Deviation|Mean
2838964|NCT00195819|Secondary|Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in MMP-3. A decrease in MMP-3 represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||ng/mL||Standard Deviation|Mean
2838965|NCT00195819|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The MCIS was a patient reported outcome where the subjects were expected to respond (yes/no) to the following question:~Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory? An increase in PASS indicates improvement.~During earlier weeks of the study PASS was measured/reported as minimal clinically important state (MCIS)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838966|NCT00195819|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life comprised of 18 questions to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are subjects with MCID <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838967|NCT00195819|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2838968|NCT00195819|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|Change from baseline in Health Utility Index Mark 3 (HUI-3) was reported. The HUI-3 is a generic approach to the measurement of health status and assessment of HRQL. The HUI-3 was comprised of two complementary components. The first component was a multi-attribute health status classification system that was used to describe health status. The second component was a multi-attribute utility function that was used to value health status as measured within the corresponding multi-attribute health status classification system. An increase in the HUI-3 score represents improvement.|Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
2838969|NCT00195819|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey completed by Subject, evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Responders are subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838970|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Change from Baseline in the SF-36 Health Survey Index was completed by Subject. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
2838971|NCT00195819|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning)to 100 (highest level of functioning).~Responders were subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838972|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure|Change from Baseline in the SF-36 Health Survey Index completed by Subject to help subject keep track of how he/she was feeling and how well he/she was able to do usual activities. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicate improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
2838973|NCT00195819|Secondary|Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260|The FACIT-Fatigue scale: overall score of 13 general questions divided into four primary Quality of Life (QoL) domains: 1) Physical Well-Being, 2) Social/Family Well-Being, 3) Emotional Well-Being, and 4) Functional Well-Being. For each question subject rates his/her condition for the past week on a 5-point scale ranging from 0 (not at all) to 4 (very much). The score ranges from 0 (highest level of fatigue) to 52 with 52 being the lowest level of fatigue.|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||unit on a scale||Standard Deviation|Mean
2838974|NCT00195819|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2838975|NCT00195819|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a VAS scale with 0 being very good and 100 being very bad.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2839021|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free Clinical Remission|Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with steroid use at baseline of preceding study, Observed Cases|||Percentage of participants|||Number
2840259|NCT00176644|Secondary|To Evaluate Measurable Disease Response in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
2838976|NCT00195819|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
2838977|NCT00195819|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||score on scale||Standard Deviation|Mean
2838978|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G consisted of two questions that asked the subject to indicate, on a 10 cm VAS, the effect the disease had on their well being over 1) last week, and 2) last 6 months. BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported. The mean of the two scores give a BAS-G score of 0-10.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2838979|NCT00195819|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||Units on a scale||Standard Deviation|Mean
2838980|NCT00195819|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.~An increase in chest expansion represents improvement"|Weeks 12, 24, 52,104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2838981|NCT00195819|Secondary|Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260|The EDASMI is a composite spinal mobility index comprised of 4 measures: 1) cervical rotation, 2) lumbar side flexion, 3) chest expansion, and 4) hip internal rotation spread. A grade of 0-4 scoring system was developed for each of the measures. The sum of 4 items (range 0 to 16) provide the EDASMI score. Decrease in EDASMI represents improvement. All EDASMI measures were done with a simple tape measure and recorded in centimeters (cm) by a rheumatologist and a clinician nurse.|Weeks 12, 24, 52, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2838982|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2839022|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 70 (CR-70)|A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
2838983|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in BASDAI in subjects with adalimumab exposure from Baseline through 5 years for the effect of adalimumab on structural damage. Partial remission was calculated as follows: A value below 20 on a 0 - 100-point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838984|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.~ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 16, 20, 24, 30, 36, 42, 48, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838985|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responder: improvement of >= 40% and absolute improvement of >= 20 units (on a scale of 0 to 100) in >= 3 of the 4 domains: Patient global assessment (VAS score [0-100 scale]); Pain (Total Back Pain VAS score 0-100 scale); Function (BASFI score 0-100 scale); Inflammation (the mean of the two morning stiffness-related BASDAI VAS scores (i.e. the average of items 5 and 6 of the BASDAI. Applied to each scale. In addition, absence of deterioration in the potential remaining domain, where deterioration is defined as a net worsening of > 0 units (on a scale of 0 to 100).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244 and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838986|NCT00195819|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicate reduction in inflammation. A decrease in CRP indicates improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mg/dL||Standard Deviation|Mean
2838987|NCT00195819|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2838988|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838997|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2840646|NCT00168844|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2838989|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838990|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100(very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||Participants|||Number
2838991|NCT00195819|Secondary|Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe].|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||particpants|||Number
2838992|NCT00195819|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI) of 0 (none) to 10 (very severe). A decrease in inflammation represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2838993|NCT00195819|Secondary|Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 128, 152, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838994|NCT00195819|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2838995|NCT00195819|Secondary|BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2838996|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 10 cm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 10 (impossible).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2838998|NCT00195819|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2838999|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100[severe]) Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; 1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2839000|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity; (0[none]-100[severe]) VAS scale; Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; (1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2839001|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2839002|NCT00195819|Primary|Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Week 12|Full analysis set - includes all subjects who were randomized and received at least one injection of study medication. The full analysis set was analyzed by treatment group.|||participants|||Number
2839003|NCT00195715|Secondary|Percentage of Subjects With Fatal Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839004|NCT00195715|Secondary|Percentage of Subjects With Hematologic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839005|NCT00195715|Secondary|Percentage of Subjects With Lupus-like Syndrome||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839006|NCT00195715|Secondary|Percentage of Subjects With Allergic Reaction-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839007|NCT00195715|Secondary|Percentage of Subjects With Hepatic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839008|NCT00195715|Secondary|Percentage of Subjects With Demyelinating Disease||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839009|NCT00195715|Secondary|Percentage of Subjects With Congestive Heart Failure||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of subjects|||Number
2839010|NCT00195715|Secondary|Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)||Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839011|NCT00195715|Secondary|Percentage of Subjects With Injection Site Reaction-related Adverse Event|"An injection site reaction is any adverse event corresponding to a preferred term beginning with injection site excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration."|Up to 262 weeks of adalimumab treatment|Safety population|||Percentage of participants|||Number
2839024|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 204|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
2839025|NCT00195715|Primary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, defined as all subjects who received at least 1 dose of study drug; Observed Cases|||Percentage of participants|||Number
2839026|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 108|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
2839027|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 48|Intent-to-treat, Observed Cases|||Percentage of participants|||Number
2839028|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 520|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 520|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
2839029|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 416|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 416|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
2839030|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 520|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
2839031|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 260|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||units on a scale||Standard Deviation|Mean
2839032|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||participants|||Number
2839042|NCT00195702|Other Pre-specified|Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.|||participants|||Number
2839223|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)|The best and worst possible overall scores are 40 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839033|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 260|Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).|||participants|||Number
2839034|NCT00195702|Other Pre-specified|Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10|Patients were responders if they had: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Baseline through Week 520|Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).|||participants|||Number
2839035|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
2839036|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
2839037|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
2839038|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).|||participants|||Number
2839039|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).|||participants|||Number
2839040|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).|||Participants|||Number
2839041|NCT00195702|Other Pre-specified|Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.|||participants|||Number
2839224|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)|The best and worst possible overall scores are 0 and 28 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839043|NCT00195702|Secondary|Estimated Yearly Progression of Rheumatoid Arthritis|Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.|||Units on a scale||Standard Deviation|Mean
2839044|NCT00195702|Secondary|Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.|||Participants|||Number
2839045|NCT00195702|Secondary|Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.|||Participants|||Number
2839046|NCT00195702|Secondary|Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.|||Participants|||Number
2839047|NCT00195702|Secondary|Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.|||Participants|||Number
2839048|NCT00195702|Secondary|Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.|||Participants|||Number
2839049|NCT00195702|Secondary|Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.|||Participants|||Number
2839050|NCT00195702|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.|||Units on a scale||Standard Deviation|Mean
2839051|NCT00195702|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.|||Units on a scale||Standard Deviation|Mean
2839052|NCT00195702|Secondary|Change From Baseline in Modified Total Sharp X-ray Score at Week 24|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.|||Units on a scale||Standard Deviation|Mean
2839053|NCT00195702|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.|||Participants|||Number
2839054|NCT00195702|Primary|Change From Baseline in Modified Total Sharp X-ray Score at Week 52|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.|||Units on a scale||Standard Deviation|Mean
2839055|NCT00195702|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.|||Participants|||Number
2839056|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who did not relapse (did not have a PGA greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.|||percentage of participants|||Number
2839057|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who had relapsed (had a PGA of greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.|||percentage of participants|||Number
2839058|NCT00195676|Other Pre-specified|Time to Relapse in Period W|Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).|Period W|Participants in the Period W Modified Intent-to-Treat Population who had relapsed (defined by a PGA of greater than or equal to 3) during Period W and had at least one post-baseline PGA assessment in Period W.|||days||95% Confidence Interval|Median
2839081|NCT00195663|Secondary|Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase|ACR-N is a composite, continuous variable which measures the percentage of improvement from Baseline in individual participants based on the 7 core set variables of the ACR. ACR-N is defined as the smallest percent change from Baseline of 3 measures: tender joint counts (TJC), swollen joint counts (SJC), and the median percent improvement in the 5 remaining measures (Patient's Assessment of Pain, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Health Assessment Questionnaire - Disability Index [HAQ-DI], and C-Reactive Protein). A positive ACR-N value indicates improvement; a negative ACR-N value indicates worsening; ACR-N of 0 indicates no change.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.|||percent change||Standard Deviation|Mean
2839059|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 120|A subset of the the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
2839060|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
2839061|NCT00195676|Primary|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|The Period R Modified Intent-to-Treat population included 178 participants who relapsed and 107 participants who did not relapse in Period W when therapy was withdrawn; all received Period R adalimumab 40 mg every other week (after an 80 mg initial dose). Results were analyzed using non-responder imputation (NRI) for missing values.|||percentage of participants|||Number
2839062|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 120|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
2839063|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.|||percentage of participants|||Number
2839064|NCT00195663|Secondary|Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A decrease in the HAQ-DI score represents an improvement in physical function; a clinically significant improvement is defined as a decrease of least 0.22 from Baseline in the HAQ-DI score. The number of participants with improvement in HAQ-DI of at least 0.22 and 0.5 units from Baseline is reported.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing HAQ-DI scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."|||participants|||Number
2839065|NCT00195663|Secondary|Number of Participants With a Major Clinical Response Over 10 Years by Adalimumab Exposure|"A major clinical response was defined as maintenance of an ACR70 response for at least a 6-month continuous period at any time during the study following the first dose of adalimumab. A participant was a responder if the following criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein)."|From the first dose of adalimumab (at Week 1 or Week 106 for patients initially randomized to methotrexate in the DB phase) to Year 10|ITT Analysis Set for participants with non-missing ACR data.|||participants|||Number
2839066|NCT00195663|Secondary|Composite Score of ACR50 Plus No Change in Modified Total Sharp Score||Year 10|This outcome measure was not analyzed due to a protocol amendment.||||||
2839866|NCT00183625|Secondary|Body Mass Index|Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months.|First 18 months of study||||kg/m^2||Standard Error|Least Squares Mean
2839067|NCT00195663|Secondary|Number of Participants With No Radiographic Progression Over 10 Years|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. The number of participants with change from Baseline ≤ 0.5 and ≤ 0 is reported as a measure of no disease progression.|Baseline (prior to first study drug treatment) and Years 2 and 10.|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."|||participants|||Number
2839068|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years|The modified TSS (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (prior to first study drug treatment) and Years 2 and 10|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."|||units on a scale||Standard Deviation|Mean
2839069|NCT00195663|Secondary|Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|After 1, 2, 5, and 10 years of adalimumab exposure|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing DAS28 scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."|||participants|||Number
2839070|NCT00195663|Secondary|Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at Baseline and the specified time point."|||units on a scale||Standard Deviation|Mean
2839071|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at each time point."|||units on a scale||Standard Deviation|Mean
2839072|NCT00195663|Secondary|Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available data. N indicates patients with non-missing data at each time point."|||participants|||Number
2839079|NCT00195663|Secondary|Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21-40% joint involvement; 3 = 3 separate quadrants with erosion or 41-60% joint involvement; 4 = all 4 quadrants with erosion or 61-80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion)to 230 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.|||units on a scale||Standard Deviation|Mean
2839867|NCT00183625|Primary|Total Weeks Worked||24 months|Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine)|||Weeks||Standard Deviation|Mean
2839073|NCT00195663|Secondary|Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available ACR data. N indicates patients with non-missing data at each time point."|||participants|||Number
2839074|NCT00195663|Secondary|Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For participants randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"Intent-to-treat (ITT) Analysis Set (all patients who received at least 1 dose of adalimumab during the study, including patients who received their first dose during the DB phase and those who received MTX during the DB phase and adalimumab in the OL phase) with available ACR data. N indicates patients with non-missing data at each time point."|||participants|||Number
2839075|NCT00195663|Secondary|Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104|"Number of participants with non-involved joints at Baseline and no newly involved joints at Weeks 52 and 104, where involved joints or no newly involved joints are defined as modified Total Sharp Score (mTSS) = 0.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease])."|Baseline and Weeks 52 and 104|Full analysis set participants with non-involved joints at Baseline and non-missing data.|||participants|||Number
2839076|NCT00195663|Secondary|Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104|"The number of participants with no erosions at Baseline and no erosions at Weeks 52 and 104, where no erosions and no new erosions are defined as an erosion score = 0.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21-40% joint involvement; 3 = 3 separate quadrants with erosion or 41-60% joint involvement; 4 = all 4 quadrants with erosion or 61-80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 230 (worst)."|Baseline and Weeks 52 and 104|Full analysis set participants with no erosions at Baseline and non-missing data.|||participants|||Number
2839077|NCT00195663|Secondary|Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase|"The number of participants with no worsening in the modified Total Sharp Score (mTSS) and in erosion and joint space narrowing (JSN) scores, where no worsening is defined as a change from Baseline of ≤ 0 in mTSS, erosion score and JSN score, at Weeks 52 and 104.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline and Weeks 52 and 104|Full analysis set. Participants with missing data or who withdrew early were considered non-responders.|||participants|||Number
2839078|NCT00195663|Secondary|Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (16 joints) and each forefoot (5 joints) on a 5-point scale (0 = no narrowing; 1 = up to 25% narrowing; 2 = 26-65% narrowing; 3 = 66-99% narrowing; and 4 = complete narrowing). Scores were summed to calculate the total score ranging from 0 (no narrowing) to 168 (maximum narrowing). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.|||units on a scale||Standard Deviation|Mean
2839080|NCT00195663|Secondary|Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839082|NCT00195663|Secondary|Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component and items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Weeks 26 and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839083|NCT00195663|Secondary|Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase|"The HUI 2/3 is an assessment of various aspects of participants' health and ability to perform various tasks on a day-to-day basis, including reading, seeing, hearing, speaking, general outlook on life, pain/discomfort, ability to walk, use of hands, memory, ability to think/solve, and ability to perform basic activities such as eating, bathing, and dressing. The HUI 2/3 is a combined 15-item questionnaire based on a recall period of the previous 4 weeks. HUI-2 and HUI-3 scores are calculated independently. The HUI-2 score includes 6 attributes: Sensation, Mobility, Emotion, Cognition, Self-Care, and Pain. The HUI-3 score is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition, and Pain.~The range of each score is from 0 (dead) to 1 (perfect health). An increase from Baseline indicates improvement."|Baseline and Weeks 26, 52, and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839084|NCT00195663|Secondary|Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Missing values were considered to be < 0.3.|||participants|||Number
2839085|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Weeks 12, 26, 76, and 104|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839086|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR70 or who withdrew early were considered non-responders.|||participants|||Number
2839087|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR20 or who withdrew early were considered non-responders.|||participants|||Number
2839088|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26 and 76|Full analysis set. Participants with insufficient data to calculate ACR50 or who withdrew early were considered non-responders.|||participants|||Number
2839114|NCT00195494|Secondary|Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death|Safety report for entire trial where participants reported a serious adverse event that led to death.|12 and 24 months|The analysis population is the modified intent to treat for year 1 (542 overall baseline participants) and year 2 (411 overall baseline participants).|||participants|||Number
2839089|NCT00195663|Secondary|Change From Baseline in the Mental Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839090|NCT00195663|Secondary|Number of Participants With Major Clinical Response After 104 Weeks of Treatment|"Major clinical response was defined as an American College of Rheumatology 70% (ACR70) response for any six continuous months, over 104 weeks of treatment. A participant was a responder if the following criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were non-responders."|Any 6 continuous months from Baseline to Week 104|Full analysis set.|||participants|||Number
2839091|NCT00195663|Secondary|Change From Baseline in the Physical Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839092|NCT00195663|Secondary|Number of Participants Who Achieved Clinical Remission, Defined as a Disease Activity 28 (DAS28) Score < 2.6 at Week 52|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 52|Full analysis set. Participants with insufficient data to calculate DAS28 at Week 52 or who withdrew early were considered non-responders.|||participants|||Number
2839093|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 104|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 104 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 104|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.|||units on a scale||Standard Deviation|Mean
2839094|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 104|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Week 104|Full analysis set. Participants with insufficient data to calculate ACR50 at Week 104 or who withdrew early were considered non-responders.|||participants|||Number
2839095|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 52|Full analysis set with available data.|||units on a scale||Standard Deviation|Mean
2839096|NCT00195663|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 52 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 52|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.|||units on a scale||Standard Deviation|Mean
2839225|NCT00194025|Secondary|Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839097|NCT00195663|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~Acute phase reactant value (C-Reactive Protein).~Participants who withdrew early were considered non-responders."|Baseline and 52 Weeks|The Full Analysis Set consisted of all patients who were randomized and who received at least one dose of double-blinded study medication. Participants with insufficient data to calculate ACR50 at Week 52 or who withdrew early were considered non-responders.|||participants|||Number
2839098|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260|All participants who received at least 1 dose of open-label adalimumab (Full Analysis Set) in the continuation study and had a Week 260 visit. Analysis used observed data (no imputation).|||units on a scale||Standard Deviation|Mean
2839099|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||units on a scale||Standard Deviation|Mean
2839100|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
2839101|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
2839102|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
2839103|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
2839115|NCT00195494|Primary|Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.|The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.|||participants|||Number
2839104|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
2839105|NCT00195650|Secondary|Reported Adverse Events|Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.|Duration of study (up to 520 weeks [10 years])|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set).|||participants|||Number
2839106|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
2839107|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).|||participants|||Number
2839108|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).|||participants|||Number
2839109|NCT00195624|Primary|Hematological Response Rate at 6 Months|Hematological response is defined as no longer satisfying blood count criteria for Severe Aplastic Anemia. Patients were classified as responders if they met two of the following three criteria: ANC greater than 500/ mm'; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3 (60,000/mm3 after January 1993).|6 months||||Participants|||Count of Participants
2839110|NCT00195507|Secondary|"Number of Patients With Survey Response of Somewhat Satisfied or Better"|Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation.|||participants|||Number
2839111|NCT00195507|Secondary|"Time to Achieve a Physician Global Assessment of Psoriasis Score of Clear or Almost Clear"|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases).|||days||95% Confidence Interval|Median
2839112|NCT00195507|Secondary|Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline|Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).|||percentage improvement|||Number
2839113|NCT00195507|Primary|Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).|||units on scale||Standard Deviation|Mean
2839116|NCT00195494|Primary|The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.|Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.|||participants|||Number
2839117|NCT00195442|Secondary|Number of Participants for Days of Sick Leave Per Month|Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839118|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Handling of ReFacto|Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839119|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Handling of ReFacto|Subjective assessment by the physician to evaluate the participants' handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839120|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Tolerance|Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839121|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Tolerance|Subjective assessment by the physician to evaluate the participants' tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839122|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Efficacy|Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839123|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Efficacy|Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839124|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success|Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.|||participants|||Number
2839125|NCT00195442|Secondary|Mean Annual ReFacto Consumption Per Patient Year|ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||International units per year||Standard Deviation|Mean
2839126|NCT00195442|Secondary|Number of Participants With de Novo Inhibitor Formation|The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit.|||participants|||Number
2839127|NCT00195442|Secondary|Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit; (n)=number of participants with events.|||events|||Number
2839128|NCT00195442|Primary|Mean Number of Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||days per year||Standard Deviation|Mean
2839130|NCT00195442|Primary|Mean Number of Bleeding Episodes Per Patient Year|Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.|||episodes per year||Standard Deviation|Mean
2839131|NCT00195429|Secondary|Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|12 months|The population that was used for this analysis was patients who completed 12 months.|||ml/min||Standard Deviation|Mean
2839132|NCT00195429|Primary|Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.|Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).|12 months|The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.|||participants|||Number
2839133|NCT00195403|Secondary|Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9|Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Month 3, 9|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis.|||joints||Standard Deviation|Mean
2839134|NCT00195403|Primary|Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3|PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.|Baseline, Month 3|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration.|||cm||Standard Deviation|Mean
2839135|NCT00195403|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.|Baseline up to Day 832|Safety population included all participants who received >= 1 dose of study medication and had the safety assessment through appropriate follow-up.|||participants|||Number
2839136|NCT00195351|Secondary|Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.|Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
2839137|NCT00195351|Secondary|Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.|||participants|||Number
2839138|NCT00195351|Primary|Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose of study drug, who had clinical evidence of complicated intra-abdominal infection, met all inclusion and exclusion criteria, and completed TOC assessment within 8-44 days after last dose of study drug. Patients with an indeterminate assessment were excluded.|||participants|||Number
2839139|NCT00195338|Secondary|Mean Dose of Concomitant Methotrexate (MTX) and Steroids||Baseline up to Month 66|Data was not analyzed due to low number of participants.|||milligram (mg)||Standard Deviation|Mean
2839226|NCT00194025|Secondary|Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|The number of participants for analysis was based on available data. Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839140|NCT00195338|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty = 0), 'adequate' (some difficulty = 1), 'limited' (much difficulty = 2), and 'unable to do' (= 3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total possible score ranged from 0 (no difficulty) to 60 (unable to do).|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
2839141|NCT00195338|Secondary|Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66|Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.|||joints||Standard Deviation|Mean
2839142|NCT00195338|Secondary|Percentage of Participants With Completion of Study Treatment||Month 12 through Month 72|FAS included all recruited participants who were either initiated or were already receiving etanercept.|||percentage of participants|||Number
2839143|NCT00195338|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 66|Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept.|||percentage of participants|||Number
2839144|NCT00195273|Secondary|Mean Creatinine Clearance Rate - 3 Months|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|3 months|All patients who completed 3 months of study drug.|||ml/min||Standard Deviation|Mean
2839145|NCT00195273|Secondary|Patient and Graft Survival|Graft survival is measured by graft loss which is defined as removal of the transplant.|12 months|All patients who received at least one dose of study drug.|||patients|||Number
2839146|NCT00195273|Secondary|Number of Patients With Acute Rejection|The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.|3 and 12 months|All patients who received at least one dose of study drug.|||patients|||Number
2839147|NCT00195273|Primary|Mean Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|12 months|All patients who completed 12 months of study drug.|||ml/min||Standard Deviation|Mean
2839148|NCT00195260|Other Pre-specified|Gene Expression at Baseline|Gene expression profile was evaluated by measuring transcript levels of messenger RNA (mRNA) in peripheral blood samples. Expression profiling of mRNA: done to measure the expressed genome of mRNA transcripts or done in a gene-specific targeted manner.|Baseline|Data was not analyzed as the analysis was cancelled due to lack of samples provided from sites.||||||
2839149|NCT00195260|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Steady state concentration was achieved at Day 15.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||ng*hour/mL||Standard Deviation|Mean
2839150|NCT00195260|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||hours||Standard Deviation|Mean
2839151|NCT00195260|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||hours||Full Range|Median
2839152|NCT00195260|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2839153|NCT00195260|Secondary|Progression Free Survival (PFS) in Part 2|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD, or from death CRFs).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||weeks||95% Confidence Interval|Median
2839154|NCT00195260|Secondary|Overall Survival (OS) in Part 2|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from death case report forms (CRFs) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||weeks||95% Confidence Interval|Median
2839155|NCT00195260|Secondary|Number of Participants With Change From Baseline in Opthalmologic Examination|Ophthalmologic evaluation included visual acuity, funduscopic examination, and any clinically-significant abnormality.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
2839156|NCT00195260|Secondary|Number of Participants With Change From Baseline in Physical Examination|Physical examinations included body weight, height and vital signs and only finding that exceeded the criterion for PCS was weight. Criteria for weight was: an increase or decrease of >=10% from baseline.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure for each group respectively.|||participants|||Number
2839157|NCT00195260|Secondary|Change From Baseline in Karnofsky Performance Score|Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (complete healthy status). Higher score means higher ability to perform daily tasks.|Baseline up to end of treatment (Week 95)|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.||||||
2839158|NCT00195260|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Day 1 up to end of treatment (Week 95) as a management of an AE was to be reported.|Day 1 up to end of treatment (Week 95)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.||||||
2839159|NCT00195260|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray|Number of participants with PCS ECG findings is reported on-therapy (OT) and at final visit (FV). Criteria for PCS ECG findings: heart rate (HR) =<45 beats/minute (bpm) and decrease (Dec) >15/>=120 bpm and decrease of >15 bpm; PR interval (Int) >=220 millisecond (msec), increase (Inc) >=20 msec, QRS Int >=120 msec, corrected QT (QTc) and QTc using fridericia formula(QTcF) Int >500 msec, increase >60 msec; no sinus rhythm; overall ECG abnormal. Participants with at least 1 measurement exceeding the criteria for PCS are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure and 'n' represents participants evaluable under each category for each group respectively.|||participants|||Number
2839160|NCT00195260|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Criteria for potentially clinically significant (PCS) laboratory values: albumin <20, hemoglobin <80 gram/liter(g/L); alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); bilirubin total, creatinine>3*ULN micromole/L; calcium <1.75 and >3.1,potassium <3 and >6, sodium <130, glucose <2.2,phosphorous <0.6 millimole/L; international normalized ratio >2*ULN, partial thromboplastin time, prothrombin time >2*ULN seconds; platelet count <50*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy laboratory assessment) for this measure for each group respectively.|||participants|||Number
2839161|NCT00195260|Secondary|Maximum Tolerated Dose (MTD) for Prolonged Use|MTD for prolonged use was the highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1) and was selected as recommended dose in Phase 2, due to substantial number of Grade 2 gastrointestinal toxicities observed in the MTD lead-in cohort (500 mg).|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.|||mg|||Number
2839162|NCT00195260|Primary|Maximum Tolerated Dose (MTD) in Part 1|MTD: highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.|||mg|||Number
2840117|NCT00179413|Secondary|Evaluation of Safety and Tolerability of Long Term Maintenance PEG-Intron in Patients With Cirrhosis|Defined as the number of patients who discontinued therapy due to an adverse event side|4 years||||Participants|||Count of Participants
2839163|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 2|BOR: investigator assessment by modified RECIST, recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 2 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||participants|||Number
2839164|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 1|BOR:investigator assessment by modified Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response:disappearance of all lesions. Partial Response (PR):>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 1 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.|||participants|||Number
2839165|NCT00195260|Primary|Duration of Most Frequently Observed Adverse Events (AEs)|The most frequently observed treatment-emergent AEs were gastrointestinal disorders which included diarrhea, nausea and vomiting. Duration of AE per event is calculated as AE stop date minus AE start date plus 1.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.|||days||Full Range|Median
2839166|NCT00195260|Primary|Number of Participants With Adverse Events (AEs) by Seriousness|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
2839167|NCT00195260|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Part 1|DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Baseline up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.|||participants|||Number
2839168|NCT00195039|Secondary|Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.||Scans will be performed between day 6 and 8.||||Participants|||Count of Participants
2839169|NCT00195039|Secondary|Assess the Survival Rate of Patients Following Treatment.||From baseline through study completion||||months||95% Confidence Interval|Median
2839170|NCT00195039|Secondary|Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).|Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.|Bone scan will be performed at baseline and Day 85.||||participants|||Number
2839171|NCT00195039|Secondary|Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.||HAHA samples will be drawn at baseline and Day 85.|Samples were collected but data necessary to summarize this outcome measure was not collected because the study team felt that there was adequate data from previous phase I studies, including repeating dosing of the study drug in this study and others that were performed prior to this study’s completion.||||||
2839172|NCT00195039|Secondary|Define the Toxicity of 177Lu-J591 Given as Single Dose.|"Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL*.~Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.~Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|From baseline until end of treatment phase (12 weeks)||||Participants|||Count of Participants
2839173|NCT00195039|Secondary|Define the Duration of Biochemical PSA and/or Measurable Disease Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A </=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A >/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions|At baseline, and up to death||||months||95% Confidence Interval|Median
2839197|NCT00194779|Primary|Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)|"Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.~Count of participants with either a pCR or mCR."|Up to 16 weeks||||Participants|||Count of Participants
2839174|NCT00195039|Primary|Define the Measurable Disease Response Rate.|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|Disease will be assessed at baseline and day 85.|Only 12 patients had measurable disease|||Participants|||Count of Participants
2839175|NCT00195039|Primary|Define the PSA Response Rate.|PSA response rate corresponds to change form baseline in PSA at any of the time points specified.|At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks||||Participants|||Count of Participants
2839176|NCT00195013|Primary|Change in Peripheral Neuropathy Score|"Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result).~Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity."|Duration of study, approximately 10 weeks per subject||||Change in Total Neuropathy Score||Full Range|Mean
2839177|NCT00194987|Secondary|Number of Fetal Platelet Counts > 50,000/uL|Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined|32 +/- 2 weeks||||number newborns with >50,000 pats|||Number
2839178|NCT00194987|Secondary|Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study|number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation|time of ICH (range 20-40 wks)||||number of newborns with ICH|||Number
2839179|NCT00194987|Primary|Number of Newborns With a Birth Platelet Count > 50,000/uL|this uses the birth platelet count of the fetuses from the study when they are born|32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40||||number of newborns with >50,000 pets|||Number
2839180|NCT00194896|Secondary|Patients Positive for T Cell Responses to Islet Proteins at 36 Months.|Number of participants positive for T cell reactivity to islet proteins at 36 months.|36 months||||participants|||Number
2839181|NCT00194896|Primary|Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.|Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.|36 months|Analysis per protocol|||ng per ml||Standard Deviation|Mean
2839182|NCT00194792|Secondary|Correlation of Molecular Markers With Response, Time to Progression, and Survival||Weekly during CHB and XMN and pacitaxel|Molecular marker data was not collected for this cohort and thus not possible to report results for this outcome.||||||
2839183|NCT00194792|Primary|Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation|Count of patients with dose reduction, treatment interruption, or treatment discontinuation.|During adjuvant and neoadjuvant chemotherapy||||Participants|||Count of Participants
2839184|NCT00194792|Primary|Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities|Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities|Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)||||events|||Number
2839185|NCT00194792|Primary|Overall Survival|From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.|Up to 5 years||||survival probability||95% Confidence Interval|Number
2839186|NCT00194792|Primary|Disease-free Survival|Kaplan-Meier estimate assessed at 5 years|Up to 5 years||||disease free survival probability||95% Confidence Interval|Number
2839187|NCT00194792|Primary|Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response|Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.|From date of treatment start to surgery||||Participants|||Count of Participants
2839188|NCT00194792|Primary|Number of Participants With Clinical Response|Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.|1 month||||Participants|||Count of Participants
2839189|NCT00194779|Secondary|Clinical Response to Paclitaxel||Up to 24 weeks||||Participants|||Count of Participants
2839190|NCT00194779|Secondary|Clinical Response to Neoadjuvant Therapy||Up to 12 weeks||||Participants|||Count of Participants
2839191|NCT00194779|Secondary|Disease-free Survival|Kaplan-Meier estimate of disease-free survival, assessed at 1, 2, and 5 years.|1, 2, and 5 years||||disease-free survival probability||95% Confidence Interval|Number
2839192|NCT00194779|Secondary|OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN|Kaplan-Meier estimate of overall survival, assessed at 1, 2, and 5 years.|1, 2, and 5 years||||survival probability||95% Confidence Interval|Number
2839193|NCT00194779|Secondary|Time to Progression|Median time to progression free survival.|Up to 5 years||||months||95% Confidence Interval|Median
2839194|NCT00194779|Secondary|Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy|Count of patients that relapsed.|Up to 8 years||||Participants|||Count of Participants
2839195|NCT00194779|Secondary|Correlation of Molecular Markers With Response||After completion of neoadjuvant therapy|Due to lack of funding, none of the tissue specimens from participants were tested for EGFR, AR, P53 and Topo2alpha expression, as originally intended by the protocol.||||||
2839196|NCT00194779|Secondary|Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation||From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if received||||Participants|||Count of Participants
2839201|NCT00194675|Secondary|The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)|International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.|Baseline, Month 3, Month 6|per protocol|||score||Standard Deviation|Mean
2839202|NCT00194675|Secondary|Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)||Baseline, Month 6|per protocol|||ng/ ml||Standard Deviation|Mean
2839203|NCT00194675|Primary|Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.||Baseline, Month 6|per protocol|||cubic centimeters||Standard Deviation|Mean
2839204|NCT00194610|Primary|Chronic Prostatitis Symptom Index (CPSI-F)|CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.|3 months|Total number of subjects was based on clinical volume, and subjects were randomized into each of two arms.|||Total CPSI-F||Standard Deviation|Mean
2839205|NCT00194532|Secondary|Microbiologic Cure|Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up|1-15 days post therapy|Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.|||participants|||Number
2839206|NCT00194532|Primary|Clinical Cure|Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin|28-30 days post therapy|modified ITT|||participants|||Number
2839207|NCT00194129|Secondary|Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex|Number of subjects who no longer met criteria for active cocaine abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex|Baseline to Month 6|This only includes subjects who were using cocaine at the time of study entry. The purpose of this analysis was to see if treatment with both open-label lithium & divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of cocaine use disorders.|||Participants|||Count of Participants
2839208|NCT00194129|Secondary|Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex|Number of subjects who no longer met criteria for active cannabis abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex|Baseline to Month 6|This only includes subjects who had a cannabis use disorder at study entry. The purpose of this analysis was to see if treatment with both open-label lithium and divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of cannabis use disorders.|||Participants|||Count of Participants
2839209|NCT00194129|Secondary|Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex|Number of subjects who no longer met criteria for active abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex|Baseline to Month 6|This only includes subjects who had an alcohol use disorder at study entry. The purpose of this analysis was to see if treatment with both open-label lithium and divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of alcohol use disorders.|||Participants|||Count of Participants
2839210|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Depressive Episode||Up to 6 months|Due to the heavily censored nature of this data, the median survival for time to treatment for emerging depression symptoms in both arms is not evaluable. Statistics software was unable to analyze the data.||||||
2839211|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode||Up to 6 months|Due to the heavily censored nature of this data, the median survival for time to treatment for emerging manic/hypomanic/mixed symptoms in both arms is not evaluable. Statistics software was unable to analyze the data.||||||
2839212|NCT00194129|Primary|Time to Treatment for Emerging Symptoms of a Mood Relapse|A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.|Up to 6 months||||weeks||95% Confidence Interval|Median
2839213|NCT00194116|Secondary|Change in Hamilton Anxiety Rating Scale (HAMA) Total Score|HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.|Acute phase (week0-week6)||||units on a scale||Standard Deviation|Mean
2839214|NCT00194116|Secondary|Change in Short Form Health Survey (SF-36) Mental Component Summary Score|SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.|Acute phase (week0-week6)|Not all subjects completed the SF-36 at study end point|||units on a scale||Standard Deviation|Mean
2839215|NCT00194116|Secondary|Change in Short Form Health Survey (SF-36) Physical Component Summary Score|SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.|Acute phase (week0-week6)|Not all subjects completed the SF-36 at study end point|||units on a scale||Standard Deviation|Mean
2839216|NCT00194116|Secondary|Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score|GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.|Acute phase (week0-week6)|Not all subjects completed the GBI at study end point|||units on a scale||Standard Deviation|Mean
2839217|NCT00194116|Secondary|Change in General Behavior Inventory (GBI) Depression Scale Score|GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.|Acute phase (week0-week6)|Not all subjects completed the GBI at study end point|||units on a scale||Standard Deviation|Mean
2839218|NCT00194116|Secondary|Change in Young Mania Rating Scale (YMRS) Total Score|YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.|Acute phase (week0-week6)||||units on a scale||Standard Deviation|Mean
2840199|NCT00176904|Primary|Overall Survival|Number of patients alive at designated timepoints after transplant.|100 Days, 1 Year and 3 Years||||Participants|||Number
2839227|NCT00194025|Secondary|Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)|The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839228|NCT00194025|Secondary|Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)|The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839229|NCT00194025|Secondary|Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)|The best and worst possible overall scores are 31 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839230|NCT00194025|Primary|Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)|The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.|||scores on a scale||Standard Deviation|Mean
2839231|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 17 of those 21 completed the ARS-IV and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
2839232|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
2839233|NCT00194012|Secondary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)|The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
2839234|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CGI-S and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
2839235|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
2839236|NCT00194012|Secondary|Clinical Global Impressions Scale (CGI-Severity)|Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||units on a scale||Standard Deviation|Mean
2839237|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis."|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 19 of those 22 and 18 of those 21 completed the CGAS and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
2839238|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis."|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2839239|NCT00194012|Secondary|Children's Global Assessment Scale (CGAS)|"Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 Doing very well to 1-10 Extremely impaired.~The score should be calculated separate from diagnosis, treatment or prognosis."|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2839240|NCT00194012|Secondary|CDRS-R Children's Depression Rating Scale-Revised|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CDRS-R and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
2839241|NCT00194012|Secondary|CDRS-R Children's Depression Rating Scale-Revised|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|12 weeks|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2839242|NCT00194012|Secondary|Children's Depression Rating Scale-Revised (CDRS-R )|The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.|Baseline|There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2839243|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|Open-Label Extension - 6 weeks|22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the YMRS and were available and included the analysis.|||Scores on a scale||Standard Deviation|Mean
2839244|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|12 weeks||||Scores on a scale||Standard Deviation|Mean
2839245|NCT00194012|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|Baseline||||Scores on a scale||Standard Deviation|Mean
2839246|NCT00193609|Secondary|Overall Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|18 months||||months||95% Confidence Interval|Median
2839247|NCT00193609|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months||||months||95% Confidence Interval|Median
2839248|NCT00193596|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|12 months||||months||95% Confidence Interval|Median
2839249|NCT00193596|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months||||months||95% Confidence Interval|Median
2839250|NCT00193492|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death or Disease Progression from NHL. Progression is defined using International Workshop Response Criteria for Non-Hodgkin's Lymphoma as - enlargment of liver/spleen, new sites, new or increased malignancy in lymph nodes, new or increased lymph node masses or reappearance of disease in bone marrow.|18 months||||months||95% Confidence Interval|Median
2839251|NCT00193492|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||percentage of participants||95% Confidence Interval|Number
2839252|NCT00193479|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months||||percentage of patients|||Number
2839253|NCT00193453|Secondary|Response Duration|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.|||Months||95% Confidence Interval|Median
2839254|NCT00193453|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.|18 months|All patients were assessed for progression-free survival.|||Months||95% Confidence Interval|Median
2839255|NCT00193453|Primary|Overall Clinical Response Rate|Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2839256|NCT00193427|Secondary|Overall Survival (OS)|Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.|18 months|All patients were assessed for overall survival after a median follow-up of 19 months.|||Months||95% Confidence Interval|Median
2839257|NCT00193427|Secondary|Overall Response Rate (ORR)|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|Patients who were assessable after completion of 9 weeks of treatment were evaluated and assigned a response category.|||Percent of patients with CR or PR|||Number
2839258|NCT00193427|Secondary|Progression Free Survival (PFS)|Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.|19 months|All patients were assessed for progression free survival after a median follow up of 19 months.|||Months||95% Confidence Interval|Median
2839259|NCT00193427|Primary|Pathologic Complete Response Rate|A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.|18 months|All patients who underwent a thoracotomy were assigned a pathologic response category.|||Percent of participants with pCR|||Number
2839260|NCT00193414|Secondary|Overall Survival (OS)|OS was measured from the date of study entry until the date of death.|18 months|All patients were assessed for OS.|||Months||95% Confidence Interval|Median
2839261|NCT00193414|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months|All patients were assessed for PFS.|||Months||95% Confidence Interval|Median
2840647|NCT00168844|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2839262|NCT00193414|Primary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|All patients were assessed for response.|||Percentage of participants with CR/PR||95% Confidence Interval|Number
2839263|NCT00193375|Primary|Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)|Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.|18 months|Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.|||Grade 3/4 Toxicity Events|||Number
2839264|NCT00193375|Secondary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 month|All patients were evaluated for response by RECIST v. 1 criteria. All patients with major responses had confirmation of response on repeat scans by the same technique(s) 4 weeks (or longer) later.|||percentage of participants||95% Confidence Interval|Number
2839265|NCT00193375|Secondary|2-Year Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.|24 months|All patients were assessed for progression free survival.|||percentage of participants|||Number
2839266|NCT00193258|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||24 months|All patients enrolled in the study|||months||95% Confidence Interval|Median
2839267|NCT00193258|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months|All patients enrolled in the trial|||months||95% Confidence Interval|Median
2839268|NCT00193258|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Eighty-seven of 94 patients (93%) received ≥ 2 months of treatment and were fully evaluable for response. Seven patients discontinued treatment during the first 8 weeks. One of these 7 patients had evidence of rapid tumor progression, whereas the remaining 6 patients discontinued treatment because of toxicity or for personal reasons.|||percentage of participants||95% Confidence Interval|Number
2839269|NCT00193219|Secondary|Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab||18 months|||||||
2839270|NCT00193219|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Measured from the date of first treatment until the date of death from any cause|36 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.|||months||95% Confidence Interval|Median
2839271|NCT00193219|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.|||months||95% Confidence Interval|Median
2839272|NCT00193219|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.|||percentage of patients||95% Confidence Interval|Number
2839273|NCT00193206|Secondary|Rates of Breast Preservation||18 months|||||||
2839274|NCT00193206|Secondary|Time to Disease Progression||18 months|||||||
2839275|NCT00193206|Secondary|Clinical Response Rates||18 months|||||||
2839276|NCT00193206|Primary|Pathologic Complete Response||18 months||||participants|||Number
2839277|NCT00193180|Secondary|Overall Survival (OS)|Defined as the time from first protocol treatment to date of death due to any cause.|18 months||||months||95% Confidence Interval|Median
2839278|NCT00193180|Secondary|Progression Free Survival (PFS)|PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|18 months||||Months||95% Confidence Interval|Median
2839279|NCT00193180|Primary|Overall Response Rate (ORR)|Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.|18 months||||percentage of participants||95% Confidence Interval|Number
2839280|NCT00193128|Secondary|Overall Survival (OS)|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|36 months|||||||
2839281|NCT00193128|Secondary|Disease-Free Survival (DFS)|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months|||||||
2839282|NCT00193128|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery|The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response|18 months|Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy|||percentage of participants|||Number
2839283|NCT00193063|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|24 months||||months||95% Confidence Interval|Median
2839284|NCT00193063|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|21 Months||||months||95% Confidence Interval|Median
2839285|NCT00193063|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months||||percentage of participants||95% Confidence Interval|Number
2839286|NCT00193050|Secondary|Overall Survival (OS)||48 months|||||||
2839287|NCT00193050|Secondary|Time to Treatment Failure (TTF)||69 months|||||||
2839288|NCT00193050|Primary|Pathologic Complete Response (pCR)||18 Months||||percentage of participants||95% Confidence Interval|Number
2839289|NCT00193037|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.|PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.|18 Months||||months||95% Confidence Interval|Median
2839290|NCT00193037|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.|18 Months|Patients who were removed from treatment before evaluation were not included in analysis|||percentage of patients||95% Confidence Interval|Number
2839291|NCT00192647|Secondary|Change From Baseline in Log10 HCV RNA Values|The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.|Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)|ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.|||Log 10 IU/mL||Standard Deviation|Mean
2839292|NCT00192647|Secondary|Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response|The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.|Weeks 4, 12, and 72|ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.|||percentage of participants|||Number
2839293|NCT00192647|Secondary|Percentage of Participants With Relapse of End-of-treatment Virological Response|Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.|Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)|ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up.|||percentage of participants|||Number
2839294|NCT00192647|Secondary|Percentage of Participants With Virological Responses Over Time|Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.|Weeks 4, 8, 12, and 24|ITT analysis population|||percentage of participants|||Number
2839295|NCT00192647|Secondary|Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period|Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.|Weeks 48|ITT analysis population|||percentage of participants|||Number
2840200|NCT00176891|Secondary|Patients With Improvement in Obstructive Apnea (Breathing) by Polysomnography||Baseline, 12 weeks after laronidase, after transplant|Data was not collected on this outcome measure and is not available for reporting.||||||
2839296|NCT00192647|Primary|Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period|Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.|Week 72|ITT analysis population|||percentage of participants|||Number
2839297|NCT00192296|Secondary|Terminal Phase Elimination Rate (Vz)|Vz of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Liters||Geometric Coefficient of Variation|Geometric Mean
2839298|NCT00192296|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Hours||Geometric Coefficient of Variation|Geometric Mean
2839299|NCT00192296|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Milliter per day||Geometric Coefficient of Variation|Geometric Mean
2839300|NCT00192296|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Percentage of Projected AUC||Geometric Coefficient of Variation|Geometric Mean
2839301|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Microgram times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2839302|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2839303|NCT00192296|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2839304|NCT00192296|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528|||Hours||Full Range|Median
2839305|NCT00192296|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants who had ADA detected at each time point|Days 14, 28, 42, and 84|All subjects who received MEDI-528|||Participants|||Number
2839306|NCT00192296|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528|||Participants|||Number
2839307|NCT00192296|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)|Days 0, 7, 14, 21, and 28|All subjects who received MEDI-528|||Participants|||Number
2839308|NCT00192296|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528|||Participants|||Number
2839309|NCT00192075|Other Pre-specified|Duration of Response - A+FOLFOX4 - Avastin Subgroup|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.|||months||95% Confidence Interval|Median
2839310|NCT00192075|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
2839311|NCT00192075|Other Pre-specified|Toxicity - Avastin Subgroup|Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events|every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.|||participants|||Number
2839312|NCT00192075|Other Pre-specified|Survival at 12 Months and 24 Months - Avastin Subgroup|Percentage of participants who were alive at 12 months and 24 months.|randomization to the date of death from any cause (up to 24 months)|The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.|||percentage of participants alive||95% Confidence Interval|Number
2839324|NCT00192036|Primary|Tumor Response at End of Treatment|Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)|All enrolled participants.|||participants|||Number
2839313|NCT00192075|Other Pre-specified|Progression-Free Survival - Avastin Subgroup|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.|||months||95% Confidence Interval|Median
2839314|NCT00192075|Other Pre-specified|Time to Progressive Disease - Avastin Subgroup|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.|||months||95% Confidence Interval|Median
2839315|NCT00192075|Other Pre-specified|Tumor Response - Avastin Subgroup|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.|||participants|||Number
2839316|NCT00192075|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
2839317|NCT00192075|Secondary|Progression-Free Survival|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
2839318|NCT00192075|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.|||months||95% Confidence Interval|Median
2839319|NCT00192075|Primary|Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent-to-Treat Population|||participants|||Number
2839320|NCT00192036|Secondary|Safety of Chemo-radiotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy|All enrolled participants receiving chemo-radiotherapy (Cycle 4).|||participants|||Number
2839321|NCT00192036|Secondary|Safety of Induction Chemotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|every cycle (21 days) for 3 cycles (up to 10 weeks)|All enrolled participants.|||participants|||Number
2839322|NCT00192036|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)|All enrolled participants.|||months||Full Range|Median
2839323|NCT00192036|Secondary|Time to Progressive Disease|Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.|Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);|All enrolled participants.|||months||Full Range|Median
2839325|NCT00192023|Other Pre-specified|Open-Label Phase Nonserious Adverse Events|Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.|||participants|||Number
2839326|NCT00192023|Other Pre-specified|Open-Label Phase Serious Adverse Events|Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.|||participants|||Number
2839327|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||units on a scale||Standard Deviation|Mean
2839328|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form|Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||standard deviation units||Standard Deviation|Mean
2839329|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||units on a scale||Standard Deviation|Mean
2839330|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
2839331|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score|The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.|||units on a scale||Standard Deviation|Mean
2839332|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale|Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
2839333|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
2839334|NCT00192023|Primary|Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.|||units on a scale||Standard Deviation|Mean
2839335|NCT00191984|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||days||95% Confidence Interval|Median
2839371|NCT00191854|Secondary|Overall Survival|Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up.|baseline to date of death from any cause (up to 34 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 23; Gemcitabine + Carboplatin = 24; Gemcitabine + Cisplatin = 22.|||months||Full Range|Median
2839336|NCT00191984|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||days||95% Confidence Interval|Median
2839337|NCT00191984|Secondary|Progression-Free Survival (PFS)|Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.|baseline to measured progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||days||95% Confidence Interval|Median
2839338|NCT00191984|Secondary|Duration of Response|"The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.~Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions."|time of response to progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least completed cycle and who had a complete or partial response.|||days||95% Confidence Interval|Median
2839339|NCT00191984|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.~Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.|||participants|||Number
2839340|NCT00191945|Secondary|Vital Signs - Weight||Baseline and 12 weeks|All randomized participants.|||kilograms||Standard Deviation|Mean
2839341|NCT00191945|Secondary|Vital Signs - Pulse||Baseline and 12 weeks|All randomized participants.|||beats per minute||Standard Deviation|Mean
2839342|NCT00191945|Secondary|Vital Signs - Diastolic Blood Pressure||Baseline and 12 weeks|All randomized participants.|||mmHg||Standard Deviation|Mean
2839343|NCT00191945|Secondary|Vital Signs - Systolic Blood Pressure||Baseline and 12 weeks|All randomized participants.|||mmHg||Standard Deviation|Mean
2839344|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 107|Intention to Treat analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2839345|NCT00191945|Secondary|Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)|The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.|Baseline|Intention to Treat analysis. All randomized participants who took at least one dose of study drug.|||participants|||Number
2839346|NCT00191945|Secondary|Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)|Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.|Baseline to 12 weeks|Intention to Treat analysis. Last observation carried forward.|||standard deviation units||Standard Deviation|Mean
2839347|NCT00191945|Secondary|Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)|The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.|Baseline and Week 12|Intention to Treat analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2839348|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and Open-Label Endpoint (107 weeks)|Intention to Treat analysis. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2839349|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 12 weeks|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
2839350|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|week 6 and week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
2840201|NCT00176891|Secondary|Development of Anti-iduronidase Antibodies in Serum||1 Year|Data was not collected on this outcome measure and is not available for reporting.||||||
2839351|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 4|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
2839352|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 6|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
2839353|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 9|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
2839354|NCT00191945|Primary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total Scores range from 0 to 54.|Week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.|||units on a scale||Standard Deviation|Mean
2839355|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
2839356|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
2839357|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
2839358|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
2839359|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2839360|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2839361|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||T-Score of units on a scale||Standard Error|Least Squares Mean
2839362|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale|Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2839363|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale|Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2839364|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2839365|NCT00191906|Secondary|Working Memory by Corsi Block Tapping Test (CBTT)|Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||blocks correctly sequenced||Standard Error|Least Squares Mean
2839366|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Pseudo Words|Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
2839367|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Correct Words|Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
2839368|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
2839369|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds||Standard Deviation|Mean
2839370|NCT00191906|Primary|Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.|||milliseconds (msec)||Standard Error|Least Squares Mean
2839372|NCT00191854|Secondary|Duration of Response|Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression.|time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Randomized patients who had either a complete response or partial response. Censored patients: Gemcitabine + Paclitaxel = 4; Gemcitabine + Carboplatin = 4; Gemcitabine + Cisplatin = 14.|||months||95% Confidence Interval|Median
2839373|NCT00191854|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 20; Gemcitabine + Carboplatin = 18; Gemcitabine + Cisplatin = 28.|||months||95% Confidence Interval|Median
2839374|NCT00191854|Secondary|Number of Participants With a Time to Treatment Failure (TTTF) Event|TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation.|randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 34; Gemcitabine + Carboplatin = 26; Gemcitabine + Cisplatin = 30.|||participants|||Number
2839375|NCT00191854|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)|Number of all randomized participants.|||participants|||Number
2839376|NCT00191815|Secondary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through eight 21-day cycles|Safety Population: all enrolled participants who received study drug.|||participants|||Number
2839377|NCT00191815|Secondary|Number of Deaths||Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|All enrolled participants.|||participants|||Number
2839378|NCT00191815|Secondary|Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades|Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.|||participants|||Number
2839379|NCT00191815|Secondary|Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination|The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.|||participants|||Number
2839380|NCT00191815|Secondary|Survival Time|Overall survival is the duration from enrollment to death due to any cause.|first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||weeks||95% Confidence Interval|Median
2839381|NCT00191815|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.|first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||weeks||95% Confidence Interval|Median
2839382|NCT00191815|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression.|first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||weeks||95% Confidence Interval|Median
2839383|NCT00191815|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Response population: all enrolled participants who had either a complete or partial response.|||weeks||95% Confidence Interval|Median
2839384|NCT00191815|Primary|Objective Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.|||participants|||Number
2839385|NCT00191789|Post-Hoc|Number of Participants With Time to Treatment Failure at Various Time Points|This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point.|baseline to stopping treatment (up to 68 months)|Intent to treat population.|||participants|||Number
2839386|NCT00191789|Post-Hoc|Number of Participants Who Died From Any Cause at Various Time Points|The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.|||participants|||Number
2839387|NCT00191789|Post-Hoc|Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study|The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.|||participants|||Number
2839388|NCT00191789|Secondary|Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery|The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery.|baseline, after eight 21-day cycles of study drug||||participiants|||Number
2839389|NCT00191789|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.|baseline to stopping treatment (up to 68 months)|Upper limit of 95% Confidence Interval of median survival was not calculable.|||weeks||95% Confidence Interval|Median
2839390|NCT00191789|Secondary|Overall Survival|Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.|baseline to date of death from any cause up to 68 months|Median was not reached|||months||95% Confidence Interval|Median
2839391|NCT00191789|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.|baseline to measured progressive disease or death from any cause (up to 68 months)|Median was not reached.|||months||95% Confidence Interval|Median
2839392|NCT00191789|Secondary|Summary of Deaths During Study||baseline through last cycle on study drug (eight 21-day cycles)|Intent to treat population.|||participants|||Number
2839393|NCT00191789|Primary|Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)|Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.|tumor assessment at baseline and during surgery after eight 21-day treatment cycles|Intent to treat population.|||participants|||Number
2839394|NCT00191724|Secondary|Difference in Pulmonary Artery (PA) Pressure|Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.|baseline, day 6, day 90|Data were not collected.|||mm Hg||Standard Deviation|Mean
2839395|NCT00191724|Secondary|Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)|Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).|baseline and day 90 (follow-up)|Population was all randomized patients who received any study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline assessment were excluded from the analyses.|||units on a scale||Standard Deviation|Mean
2839396|NCT00191724|Secondary|Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios|Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography|baseline, day 6, day 90|Population is all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline measure at Day 6 or Day 90 were excluded from the analysis of change from baseline to day 6 or day 90, respectively.|||ratio||Standard Deviation|Mean
2839441|NCT00191282|Secondary|Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839397|NCT00191724|Primary|Number of Participants With Major Bleeding Events|Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.|baseline through day 6|The population analyzed was all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo].|||participants|||Number
2839398|NCT00191646|Secondary|Overall Survival|Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to death from any cause up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored.|||months||95% Confidence Interval|Median
2839399|NCT00191646|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to stopping treatment up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored.|||months||95% Confidence Interval|Median
2839400|NCT00191646|Secondary|Proportion of Participants With Response (Response Rate)|Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).|Baseline to measured progressive disease up to 82 months|All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis.|||proportion of responders||95% Confidence Interval|Mean
2839401|NCT00191646|Primary|Progression Free Survival (PFS)|Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to measured progressive disease or death up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.|||Months||95% Confidence Interval|Median
2839402|NCT00191477|Secondary|Tumor Recurrence Type|Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition).|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.|||participants|||Number
2839403|NCT00191477|Secondary|Recurrence-Free Survival (RFS) in Subgroups|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.|||months||Full Range|Median
2839404|NCT00191477|Secondary|Time to Recurrence|Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.|||months||Full Range|Median
2839443|NCT00191282|Secondary|Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839405|NCT00191477|Post-Hoc|Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months|RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.|||percentage of participants|||Number
2839406|NCT00191477|Post-Hoc|Percentage of Participants Without Tumor Recurrence|Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.|||percentage of participants|||Number
2839407|NCT00191477|Primary|Recurrence-Free Survival (RFS)|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo.|||Months||Full Range|Median
2839408|NCT00191451|Secondary|Percentage of Patients With Overall Survival at 1 Year and 2 Years|Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.|1 Year, 2 Years|Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+).|||percentage of participants|||Number
2839409|NCT00191451|Secondary|Time to Disease Progression (TTP)|If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.|randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)|Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+).|||months||95% Confidence Interval|Median
2839410|NCT00191451|Secondary|Number of Patients Who Experienced Alopecia||Baseline to 3.5 years|Number of patients who received at least one dose of study drug.|||participants|||Number
2839411|NCT00191451|Secondary|Duration of Response|Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.|date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)|Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+).|||months||Full Range|Median
2839412|NCT00191451|Primary|Overall Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to disease progression/recurrence (up to 3.5 years)|Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy.|||participants|||Number
2839413|NCT00191386|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM.|Over 1 year|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.|||Participants|||Number
2839414|NCT00191386|Secondary|Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)|Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.|||Units on a scale||Standard Deviation|Mean
2839442|NCT00191282|Secondary|Number of Participants Who Experienced Congestive Heart Failure|Occurrence of congestive heart failure (newly diagnosed after Visit 2).|Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839415|NCT00191386|Secondary|Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.|||Units on a scale||Standard Deviation|Mean
2839416|NCT00191386|Primary|Number of Participants With Adverse Events for Long Term Safety and Tolerability|Details on the actual adverse events are presented in the Reported Adverse Events Section.|Baseline through 4 years|All patients who took at least one dose of study medication were included in the analyses of safety data.|||Participants|||Number
2839417|NCT00191334|Secondary|Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade|Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).|every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||participants|||Number
2839418|NCT00191334|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||weeks||95% Confidence Interval|Median
2839419|NCT00191334|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||weeks||95% Confidence Interval|Median
2839420|NCT00191334|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up||||weeks||95% Confidence Interval|Median
2839421|NCT00191334|Primary|Best Overall Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up||||participants|||Number
2839422|NCT00191308|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.|Treatment start to death from any cause (up to 47.6 months)|OS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2839423|NCT00191308|Secondary|Disease Free Survival (DFS)|DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.|Treatment start to disease progression or death from any cause (up to 45.5 months)|DFS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.|||months||95% Confidence Interval|Median
2839424|NCT00191308|Secondary|Duration of Response|The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.|Time of response to disease progression (up to 44.4 months)|Duration of response was analyzed on responders treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy; responder.|||months||95% Confidence Interval|Median
2839425|NCT00191308|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate)|Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.|Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)|Tumor response rate and 95% confidence interval (CI) of best CR or PR were evaluated on all qualified enrolled participants treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.|||percentage of participants||95% Confidence Interval|Number
2839426|NCT00191308|Primary|High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood|Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.|Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)|Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted.|||participants|||Number
2839427|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized participants with self-reported hypoglycemia during Month 18.|||episodes of hypoglycemia|||Number
2839428|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
2839429|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized participants with self-reported hypoglycemia during Month 12.|||episodes of hypoglycemia|||Number
2839430|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
2839431|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized participants with self-reported hypoglycemia during Month 9.|||episodes of hypoglycemia|||Number
2839432|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
2839433|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized participants with self-reported hypoglycemia during Month 6.|||episodes of hypoglycemia|||Number
2839434|NCT00191282|Other Pre-specified|Summary of Reasons for Deaths||Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839435|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
2839436|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized participants who self-reported hypoglycemia during Month 3.|||episodes of hypoglycemia|||Number
2839437|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized patients who took at least one dose of study drug and who were still in the study.|||participants|||Number
2839438|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized participants who self-reported hypoglycemia during Month 1.|||episodes of hypoglycemia|||Number
2839439|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839440|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Angiography Planned After Randomization||Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839444|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Revascularization Procedures|Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.|Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839445|NCT00191282|Secondary|Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)||Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839446|NCT00191282|Secondary|Number of Participants Who Experienced Stroke|Occurrence of stroke (fatal, nonfatal, any).|Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839447|NCT00191282|Secondary|Number of Participants Who Experienced Myocardial Infarction (MI)|Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).|Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839448|NCT00191282|Secondary|Number of Participants Who Experienced Cardiovascular (CV) Death||Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839449|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause||Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839450|NCT00191282|Secondary|Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors|Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839451|NCT00191282|Secondary|Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control|Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839452|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes|Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.|Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.|||participants|||Number
2839453|NCT00191282|Primary|Number of Participants Who Experienced a Primary Combined Outcome|The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.|Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug|||participants|||Number
2839454|NCT00191269|Secondary|Pharmacokinetics - Normalized Area Under the Curve|Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.|cycle 1|Pharmacokinetic data were available on 12 participants.|||nanograms times hour per milliliter||Full Range|Geometric Mean
2839455|NCT00191269|Secondary|Pharmacokinetics - Normalized Cmax|maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.|cycle 1|Pharmacokinetic data were available from 12 patients.|||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
2839456|NCT00191269|Secondary|Survival at 1 Year|Results are reported as number of participants alive at one year.|baseline to date of death from any cause, evaluate at 1 year||||participants|||Number
2839457|NCT00191269|Secondary|Time to Progressive Disease|Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|baseline to measured progressive disease||||days||95% Confidence Interval|Median
2839458|NCT00191269|Secondary|Duration of Response|For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|time of response to progressive disease|The 5 responding participants (complete response and partial response) at Dose Level 2.|||months||95% Confidence Interval|Median
2839459|NCT00191269|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease||||participants|||Number
2839460|NCT00191191|Secondary|Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)|FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
2839461|NCT00191191|Secondary|Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)|20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
2839462|NCT00191191|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||months||95% Confidence Interval|Median
2839463|NCT00191191|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.|time of response to progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||months||95% Confidence Interval|Median
2839464|NCT00191191|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.|||participants|||Number
2839465|NCT00191165|Secondary|Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient's height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|24 Months|All enrolled participants with at least one post-baseline height velocity measurement, using the last observation available prior to the 24-month visit if the 24-month height velocity was not available.|||standard deviation score||Standard Deviation|Mean
2839466|NCT00191165|Secondary|Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS)|This was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient's height and then dividing this value by the age-and-gender-matched population height SD.|Baseline, 12-Months, 24-Months|All enrolled participants with at least one post-baseline height measurement, using last observation available prior to 12-month and 24-month visits respectively, if 12-month or 24-month height was not available.|||standard deviation score||Standard Error|Least Squares Mean
2839467|NCT00191165|Primary|Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient's height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|12-Months|All enrolled participants with baseline and 12-month height measurements.|||standard deviation score||Standard Deviation|Mean
2839468|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)|Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment|||units on a scale||Standard Deviation|Mean
2839469|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|Baseline until crossover treatment began (up to 82 months)|Participants with RSCL at baseline and end of initial treatment.|||units on a scale||Standard Deviation|Mean
2839470|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)|Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment|||units on a scale||Standard Deviation|Mean
2839471|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|Baseline until crossover treatment began (up to 82 months)|Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.|||units on a scale||Standard Deviation|Mean
2839472|NCT00191152|Secondary|Best Overall Response (Crossover Treatment)|Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|Only included participants who crossed over from initial treatment to crossover treatment.|||participants|||Number
2839473|NCT00191152|Secondary|Best Overall Response (Initial Treatment)|Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|ITT population.|||participants|||Number
2839474|NCT00191152|Secondary|Overall Survival|Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.|Date of randomization to date of death from any cause (up to 82 months)|Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
2839475|NCT00191152|Secondary|Duration of Response (Crossover Treatment)|At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.|Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)|ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.|||months||95% Confidence Interval|Median
2839476|NCT00191152|Secondary|Duration of Response (Initial Treatment)|Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.|Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)|ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
2839477|NCT00191152|Primary|Time to Disease Progression (Initial Treatment)|Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.|Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)|Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
2839478|NCT00191152|Secondary|Progression-Free Survival (Crossover Treatment)|For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.|First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.|||months||95% Confidence Interval|Median
2839479|NCT00191152|Secondary|Progression-Free Survival (Initial Treatment)|For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.|Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)|ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.|||months||95% Confidence Interval|Median
2839494|NCT00191113|Secondary|Maximum Fasting Glucose Value|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2839868|NCT00183469|Primary|Mania Rating Scale|Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.|up to 8 months|all randomized subjects|||units on a scale||Standard Error|Mean
2839480|NCT00191152|Secondary|Time to Disease Progression (Crossover Treatment)|For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.|Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.|||months||95% Confidence Interval|Median
2839481|NCT00191139|Secondary|Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization|LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.|baseline to 3 months after last dose of study treatment (three 21-day cycles)|as-treated population|||participants|||Number
2839482|NCT00191139|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause up to 2057 days|ITT population|||days||95% Confidence Interval|Median
2839483|NCT00191139|Secondary|Progression-Free Survival|Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.|baseline to measured progressive disease up to 2057 days|ITT population|||days||95% Confidence Interval|Median
2839484|NCT00191139|Secondary|Number of Patients With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).|randomization and every 3 months up to 2 years of post-study followup|ITT population|||participants|||Number
2839485|NCT00191139|Primary|2-Year Survival|Percentage of participants alive at 2 years.|2 years|Intention to treat (ITT) population|||percentage of participants|||Number
2839486|NCT00191113|Secondary|Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data.|||participants|||Number
2839487|NCT00191113|Secondary|Maximum Glycosylated Hemoglobin|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||percent (%)||Standard Deviation|Mean
2839488|NCT00191113|Secondary|Glycosylated Hemoglobin, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.|||percent (%)||Standard Error|Least Squares Mean
2839489|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value|Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data. Calculated only for patients with fasting blood <100 mg/dL.|||participants|||Number
2839490|NCT00191113|Secondary|Minimum Fasting Glucose/Insulin Ratio Values|Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||milligrams per 10^-4 Units (mg/[10^-4]U)||Standard Deviation|Mean
2839491|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Insulin Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data|||participants|||Number
2839492|NCT00191113|Secondary|Maximum Fasting Insulin Values|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.|||micro International Units per milliliter||Standard Deviation|Mean
2839493|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data|||participants|||Number
2839869|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||18 months||||participants|||Number
2839870|NCT00183456|Primary|Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)||18 months||||participants|||Number
2839495|NCT00191113|Secondary|Fasting Glucose, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.|||mg / dL||Standard Error|Least Squares Mean
2839496|NCT00191113|Secondary|Number of Participants With Hearing Loss, Audiologist Assessment|Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.|at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination for whom Audiologist responded to Hearing Loss question|||participants|||Number
2839497|NCT00191113|Secondary|Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination|||participants|||Number
2839498|NCT00191113|Secondary|Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination|||participants|||Number
2839499|NCT00191113|Secondary|Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination|||participants|||Number
2839500|NCT00191113|Secondary|Height (Centimeters [cm])|Most mature measurement available, at or after attainment of Final Height.|every 3 months during core study, and at start and end of 4-year addendum||||centimeters (cm)||Standard Error|Least Squares Mean
2839501|NCT00191113|Secondary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|every 3 months during core study, and at start and end of 4-year addendum||||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
2839502|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.|at completion of core study, or at end of 4-year addendum|Population of patients for whom Final Height measurements are available. Efficacy analysis with as-treated treatment groups, at most mature measurement available at or after attainment of Final Height.|||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
2839503|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|Baseline, and end of 4-year addendum|Population of all randomized patients. Intent to treat analysis with as-randomized treatment groups, at most mature measurement available.|||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
2839504|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points|Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.|||participants|||Number
2839505|NCT00191100|Secondary|Number of Participants Who Died From Any Cause at Various Time Points|Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.|baseline to date of death from any cause (includes 60 month follow-up period)|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.|||participants|||Number
2839506|NCT00191100|Secondary|Tumor Response|Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned.|||participants|||Number
2839507|NCT00191100|Secondary|Local Failure Rate|Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received.|||proportion of participants with PD|||Number
2839508|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points|Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.|||participants|||Number
2839509|NCT00191100|Primary|Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years|"Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented."|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned.|||participants|||Number
2839510|NCT00190983|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause (up to 5 years)||||months||Full Range|Median
2839511|NCT00190983|Secondary|Progression-Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline until documented tumor progression (up to 5 years)|All enrolled participants who experienced disease progression.|||months||Full Range|Median
2839512|NCT00190983|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 5 years)|All enrolled participants who had either a complete response (n=0) or partial response (n=4).|||months||Full Range|Median
2839513|NCT00190983|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (up to 5 years)||||participants|||Number
2839514|NCT00190775|Secondary|Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, after 2-week titration period beginning at Week 24|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839515|NCT00190775|Secondary|Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 2 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839516|NCT00190775|Secondary|Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 1 week|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839517|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)|"Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants."|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839871|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)||18 months||||participants|||Number
2839872|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)||18 months||||participants|||Number
2839518|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)|The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839519|NCT00190775|Secondary|Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician's assessment of the severity of ADHD symptoms in relation to the clinician's total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site.|Baseline, 8 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839520|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores|18-item scale that captures the 18-item DSM-IV symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839521|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839522|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839523|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags|Items 19-26 of the CDBRS assess the presence of Oppositional Defiant Disorder (ODD) (yes if participant answers >=4 items as 2 [often] or 3 [very often]). Items 1-26 are rated on a 0-3 scale (0=never/rarely, 1=sometimes, 2=often, 3=very often). 15 yes/no items assess the presence of Conduct Disorder (yes if >3 items answered yes). Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Participants|||Number
2839524|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form|Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839525|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 24 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839526|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 12 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839873|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)||18 months||||participants|||Number
2839527|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839528|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 12 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839529|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics' subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839530|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics' subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839531|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839532|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics' subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839533|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics' subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839534|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||Units on a scale||Standard Deviation|Mean
2839535|NCT00190775|Primary|Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 12 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included. The protocol was amended to extend the open-label portion of the study from 8 weeks to 12 weeks, and the primary objective was modified to include the CAARS-IV:SV at 12 weeks.|||Units on a scale||Standard Error|Least Squares Mean
2839536|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839537|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839538|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839539|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839540|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839541|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839554|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
2839874|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)||18 month||||participants|||Number
2839542|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839543|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.|||T-scores of units on a scale||Standard Deviation|Mean
2839544|NCT00190775|Primary|Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 24 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.|||Units on a scale||Standard Error|Least Squares Mean
2839545|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses|Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.|baseline and 12 weeks.|Mean change from baseline, all randomized patients, double-blind treatment period|||nanomoles per Liter (nmol/L)||Standard Deviation|Mean
2839546|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides|Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2839547|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)|Fasting lipid parameters including HDL change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2839548|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)|Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2839549|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol|Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2839550|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores|Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
2839551|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores|Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
2839552|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores|The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
2839553|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores|A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
2839875|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||12 months||||participants|||Number
2839876|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)||12 months||||participants|||Number
2839555|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores|Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.|baseline and 12 weeks|BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period|||units on a scale||Standard Deviation|Mean
2839556|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area|Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||ratio in square centimeters (cm2)||Standard Deviation|Mean
2839557|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area|Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations|||square centimeters (cm2)||Standard Deviation|Mean
2839558|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Visceral Fat Area|Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations|||square centimeters (cm2)||Standard Deviation|Mean
2839559|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Waist Circumference|Waist circumference change from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||centimeters||Standard Deviation|Mean
2839560|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Weight change from baseline to last visit (last observation carried forward)|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||kilograms||Standard Deviation|Mean
2839561|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Body Mass Index|Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||kilograms per square meter (kg/m2)||Standard Deviation|Mean
2839562|NCT00190749|Secondary|Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839563|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839564|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||correlation|||Number
2839565|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations|||correlation|||Number
2839566|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839567|NCT00190749|Secondary|Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839568|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839569|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839570|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.|Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839571|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839572|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839573|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.|||correlation|||Number
2839574|NCT00190749|Primary|Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate|Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]|baseline and 12 weeks|N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.|||Mffm/I||Standard Deviation|Mean
2839575|NCT00190684|Primary|Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group|"Tanner Stage:~I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs~Age Groups:~age<11.0 (female) and age<12 (male)~11=<age<12 (female) or 12<=age<13 (male)~12=<age<15 (female) or 13=<age<15 (male)~age>=15 (female and male)"|1 year through 5 years|The analysis population is defined as patients with at least two Tanner measurements.|||participants|||Number
2839576|NCT00190684|Primary|Number of Participants With Abnormal Laboratory Analytes During the Study|Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10^12 units/liter; Giga/liter (GI/L)or 10^9 units/liter; femtoliters (fL); urinalysis (UA)|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||participants|||Number
2839577|NCT00190684|Primary|Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is <430 ms, Borderline is >=430 ms and <450 ms, Prolonged is >=450 ms. For Females: Normal is <450 ms, Borderline is >=450 ms and <470 ms, Prolonged is >=470 ms.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||participants|||Number
2839578|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test|Only patients who took the Stroop Color Word Test in a previous atomoxetine study were required to complete the Stroop in this study. Stroop measures inhibition of dominant response and interference control. Patients were given tasks of recognition (colors), reading (where a word represents a color), and interference (reading words written in different colors). There were 100 items for each of the three categories and if they made it through 100 words with time remaining, they would repeat the list. Only a small number of patients had Stroop tests in this study, so no analysis was done.|baseline, 5 years|There were not enough participants with prior Stroop Word Color tests to analyze the data.|||number of correct answers||Standard Deviation|Mean
2839579|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||units on a scale||Standard Deviation|Mean
2839580|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||units on a scale||Standard Deviation|Mean
2839581|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||units on a scale||Standard Deviation|Mean
2839582|NCT00190684|Primary|Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||participants|||Number
2839583|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Heart Rate|Patients were assessed for changes in heart rate using electrocardiogram.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||beats per minute (bpm)||Standard Deviation|Mean
2839584|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)|Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||milliseconds (msec)||Standard Deviation|Mean
2839585|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile|Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement.|||percentiles||Standard Deviation|Mean
2839586|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Height||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||centimeters (cm)||Standard Deviation|Mean
2839587|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Body Weight||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||kilograms (kg)||Standard Deviation|Mean
2839588|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Pulse||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||beats per minute (bpm)||Standard Deviation|Mean
2839589|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in BP||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.|||millimeters of Mercury (mmHg)||Standard Deviation|Mean
2839590|NCT00190684|Primary|Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study|Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.|Baseline through 5 years|For each vital sign, the number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug. Number of subject analyzed for each vital sign is provided.|||participants|||Number
2839591|NCT00190671|Secondary|Pharmacokinetics - Half-Life (t½)|The half-life associated with the terminal elimination rate constant.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||hours||Full Range|Geometric Mean
2839592|NCT00190671|Secondary|Pharmacokinetics - Volume of Distribution|Central volume (V1) and peripheral volume (V2) of distribution.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||Liters||Full Range|Geometric Mean
2839593|NCT00190671|Secondary|Pharmacokinetics - Clearance (CL)|Total body clearance of drug calculated after intravenous administration.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||milliliters per minute||Full Range|Geometric Mean
2839594|NCT00190671|Secondary|Pharmacokinetics - Area Under the Curve (AUC)|Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||hour times microgram per milliliter||Full Range|Geometric Mean
2839595|NCT00190671|Secondary|Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)||cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.|||micrograms per milliliters||Full Range|Geometric Mean
2839669|NCT00187096|Secondary|Percent of Detectable Donor NK Cells at Day 28|The percent of detectable donor NK cells in recipients at 28 days after NK cell infusion. Three of 10 participants had detectable donor cells at week 4. The results report the percent of detectable cells in the 3 participants.|At 28 days|Three of 10 participants continued to have detectable donor NK cells at week 4.|||percent of donor NK cells||Full Range|Median
2839596|NCT00190671|Secondary|Progression Free Survival|Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). The Progression Free Survival date was censored for 22 (35.07%) participants.|||months||95% Confidence Interval|Median
2839597|NCT00190671|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). Time to disease progression was censored for 26 (42.6%) participants.|||months||95% Confidence Interval|Median
2839598|NCT00190671|Primary|Best Tumor Response|Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.|baseline to measured progressive disease|Number of randomized participants.|||participants|||Number
2839599|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)|||mm Hg / mm Hg||Standard Error|Mean
2839600|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)|||mm Hg / mm Hg||Standard Error|Mean
2839601|NCT00189540|Secondary|Number of Subjects Who Undergo a Major Amputation||Month 3 and Month 6||||participants|||Number
2839602|NCT00189540|Secondary|Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)|The mean VAS score where 0 = no pain; 10 = worst possible pain.|Baseline, Month 3 and Month 6|"Per protocol population or Efficacy Evaluable EE"|||cm||Standard Error|Mean
2839603|NCT00189540|Secondary|Percentage of Participants Where All Ulcers Healed|This outcome is a percentage of participants where all of their baseline ulcers healed.|Month 3 and Month 6|"Per protocol population Efficacy Evaluable EE"|||Percentage of Participants|||Number
2839604|NCT00189540|Primary|Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)|Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6|Baseline, Month 3, Month 6|Per protocol population - Efficacy Evaluable or EE|||total wound area (cm^2)||Standard Error|Mean
2839605|NCT00189488|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The modified Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS.~The modified OMDQ was completed once daily beginning with the first day of study drug administration through day 28.~The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness)."|The first day of study drug administration through Day 28.|Primary analysis set|||MTS score * days||Standard Deviation|Mean
2839606|NCT00189488|Secondary|Duration of Hospitalization|Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant.|From transplant (Day 0) until Day 100|Primary analysis set|||days||Standard Deviation|Mean
2839607|NCT00189488|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|From transplant (Day 0) until Day 100|Primary Analysis Set|||Participants|||Number
2839608|NCT00189488|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis.|From transplant (Day 0) until Day 100|Primary Analysis Set|||days||Standard Deviation|Mean
2839609|NCT00189488|Secondary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|"Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed:~while participants were hospitalized, including the day of discharge (maximum until day 28);~after discharge until the oral mucositis grade returns to a WHO grade ≤ 2.~The WHO oral toxicity criteria are: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|From transplant (Day 0) until Day 100|Primary Analysis Set|||Participants|||Number
2839610|NCT00189488|Secondary|Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration|Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2, respectively.|Day 11|Primary Analysis Set|||Participants|||Number
2839611|NCT00189488|Primary|Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.~Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.~Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.~Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment.|||Participants|||Number
2839764|NCT00185692|Primary|Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning|number achieving donor cell engraftment (>95%) by day 90 after transplant.|100 days||||Participants|||Count of Participants
2839612|NCT00189488|Secondary|Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.~Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.~Grade 2 GVHD = > 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence.~Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.~Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments.|||Participants|||Number
2839613|NCT00189475|Primary|Nasal Secretion Weights||6 days after naturally acquiring an upper respiratory infection||||grams||Standard Error|Mean
2839614|NCT00189462|Primary|Incidence of Acute Otitis Media||16 weeks||||participants with AOM|||Number
2839615|NCT00189436|Secondary|Spirometry Readings||3 weeks|||||||
2839616|NCT00189436|Secondary|Urinary Cortisol||3 weeks|||||||
2839617|NCT00189436|Primary|Wheezing/Asthma/Bronchospasm Relapse Rate|Asthma relapse rate was 6.5% and 4% in the nebulized budesonide and standard care groups, respectively|3 weeks||||percentage of cases of asthma relapse|||Number
2839618|NCT00189423|Secondary|Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)]|CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores.|One year after index arrest||||units on a scale||Standard Deviation|Mean
2839619|NCT00189423|Secondary|Survival to 365 Days|Number of patients who are alive 365 days after the index cardiac arrest.|365 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria.|||patients|||Number
2839620|NCT00189423|Secondary|Survival to 90 Days|Number of patients who are known to be alive 90 days after the index cardiac arrest.|90 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria.|||patients|||Number
2839621|NCT00189423|Secondary|Survival to Hospital Discharge||cardiac arrest to hospital discharge||||patients|||Number
2839622|NCT00189423|Secondary|Survival to 24 Hours|Number of patients who were alive 24 hours after the initial cardiac arrest.|24 hours following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria.|||patients|||Number
2839623|NCT00189423|Secondary|Survival to Hospital (e.g., Intensive Care Unit) Admission|Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.|Time of hospital admission, up to 1 day after cardiac arrest|Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met final inclusion criteria.|||patients|||Number
2839624|NCT00189423|Secondary|Return of Spontaneous Circulation (ROSC)|Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.|Time of cardiac arrest until discontinuation of efforts|Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria.|||patients|||Number
2839625|NCT00189423|Secondary|Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events|Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury.|Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge|Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria.|||patients|||Number
2839626|NCT00189423|Primary|Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3|favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention.|When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge|The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria.|||patients|||Number
2839627|NCT00189306|Secondary|Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks|Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)|12 week posttreatment visit|Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen.|||participants|||Number
2839628|NCT00189306|Primary|Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)|Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.|5 years|2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required|||participants|||Number
2839644|NCT00187889|Secondary|Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group|Coronary flow reserve is a ratio of coronary blood flow velocity before and after adenosine. The outcome measure is the difference between the coronary flow reserve at 16 weeks adjusted for coronary flow reserve at baseline.|16 weeks|See Primary Outcome. The studied was only powered for the primary outcome. All completers are included per protocol analysis.|||difference of ratios (unitless)||Standard Deviation|Mean
2839877|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||6 months||||participants|||Number
2839629|NCT00189228|Primary|Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution|Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. This is measured by ELISA and expressed as ELISA units which are derived by dilution of serum samples until the result falls on a linear portion of the response curve. Final values are derived from ELISA units and the serum dilution|6 months|Anti-KLH antibody levels of the groups (asthmatics treated with Xolair and placebo) were compared. Both parametric and non parametric statistical techniques were used. There were no differences between the groups.|||Units of anti-KLH antibody||Standard Error|Mean
2839630|NCT00189202|Secondary|Blood Pressure Control|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication|12 months||||Participants|||Count of Participants
2839631|NCT00189202|Secondary|Drug-treated Dyslipidemic Syndrome|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome|12 months||||Participants|||Count of Participants
2839632|NCT00189202|Secondary|Incidence of Post Transplant Diabetes|To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus|12 months||||Participants|||Count of Participants
2839633|NCT00189202|Primary|One-year Patient Survival|To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival|12 months||||Participants|||Count of Participants
2839634|NCT00189202|Primary|One-year Graft Survival|To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival|12 months||||Participants|||Count of Participants
2839635|NCT00189202|Primary|Cumulative One-year Acute Rejection Rates|To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant|12 months||||Participants|||Count of Participants
2839636|NCT00189137|Secondary|The Percentage of Patients Alive Without Disease at 2 Years|Disease-free survival|2 years||||percentage of patients|||Number
2839637|NCT00189137|Primary|Percentage of Patients Hospitalized in Each Arm.|To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.|12 weeks||||percentage of patients hospitalized|||Number
2839638|NCT00189098|Secondary|Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.|After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|between 12 weeks and 1 year follow-up||||participants|||Number
2839639|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.|Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 12 weeks and 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.|||participants|||Number
2839640|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.|Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 6 and 12 weeks follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.|||participants|||Number
2839641|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up|Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.|between 12 weeks to 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.|||participants|||Number
2839642|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up|Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.|Between 6 to12 week follow up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.|||participants|||Number
2839643|NCT00189098|Primary|Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear|The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.|6, 12 weeks and 1 year follow-up.|intention to treat|||participants|||Number
2839645|NCT00187889|Primary|Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group|The primary measure was the relative change in coronary diameter to acetylcholinem (ACH) at 16 weeks adjusted for baseline reactivity to acetylcholine. Change in coronary artery diameter after ACH was measured in mm at baseline and 16 weeks. Percent change at 16 weeks - percent change at baseline was the outcome.|16 weeks|power analysis: Study planned to detect a 12% difference in change from baseline to 16 weeks between treatment groups (SD=14%), in the primary outcome leading to a planned sample size of 22 per group (44 total) for 80% power, P=0.05 2-sided. Study allowed for 6 dropouts, leading to a final N=50 planned (25 per group). Per protocol analysis used.|||% change wk16-%change wk0- unitless||Standard Deviation|Mean
2839646|NCT00187876|Primary|International Knee Documentation Committee (IKDC) Form|The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.|24 month period||||score||95% Confidence Interval|Mean
2839647|NCT00187720|Primary|Renal Clearance of Metformin|To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.|0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours|Analysis was per protocol. The sample size of 23 subjects will enable us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the renal clearance of metformin between individuals who are homozygous for the reference OCT2 and those who carry the OCT2 variant A270S allele.|||mL/min||Standard Deviation|Mean
2839648|NCT00187681|Primary|Glucose Lowering Response to Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered glucose lowering response to metformin we will measure the difference in area under the glucose concentrations-time curve (Glucose AUC) following oral glucose tolerance test.|0 to 180 minutes|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacodynamics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.|||min * mg/dL||Standard Deviation|Mean
2839649|NCT00187681|Primary|Area Under the Curve (AUC) of Blood Concentration-time of Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered pharmacokinetics of metformin, the difference in AUC of blood concentration-time of metformin between reference and variant groups will be measured.|0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacokinetics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.|||hour * µg/L||Standard Deviation|Mean
2839650|NCT00187655|Primary|Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype|Participants were stratified by their OCT3 genotype, heterozygous vs homozygous. The renal clearance of cefotaxime was measured by urine content of cefotaxime metabolites in participants after the single IV push administration of 2 grams of cefotaxime.|post dose up to 24 hours|The OAT3 Ile305Phe variant was determined to be heterozygous or homozygous for each healthy participant.|||mL/min||Standard Deviation|Mean
2839651|NCT00187486|Secondary|Progression Free Survival|Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion|every 2 months measure by MR imaging, up to 39 months||||months||Full Range|Median
2839652|NCT00187486|Primary|Overall Survival|Patients were monitored until death|assessment of survival was every 2 months, up to 181 weeks|The analysis was per protocol, and intention to treat. Median overall survival measured from the date of registration was the primary endpoint.|||months||Full Range|Median
2839653|NCT00187226|Primary|Local Tumor Control|Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.|12 months after the enrollment of the last therapeutic patient|Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis.|||Proportion of patients||95% Confidence Interval|Log Mean
2839654|NCT00187200|Secondary|Left Ventricular Ejection Fraction (LVEF)|Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).|Randomization and 9 months||||percentage||Standard Deviation|Mean
2839655|NCT00187200|Secondary|6 Minute Hall Walk Distance Test (6-MHWD)|Patients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.|6 months||||participants|||Number
2839656|NCT00187200|Secondary|NYHA Class Progression|New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.|6 months|Per protocol analysis|||participants|||Number
2839657|NCT00187200|Primary|CRT Responder Rate|Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.|6 months|Per protocol analysis.|||participants|||Number
2839765|NCT00185679|Secondary|Platelet Recovery|Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions|40 days||||participants|||Number
2839658|NCT00187135|Secondary|Movement|Movement (yes/no) measured during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
2839659|NCT00187135|Secondary|20% or Greater Change in Blood Pressure|Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
2839660|NCT00187135|Secondary|20% or Greater Change in Respiratory Rate|Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
2839661|NCT00187135|Secondary|20% or Greater Change in Heart Rate|Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.|||Participants|||Number
2839662|NCT00187135|Primary|Pain (Yes/No)|"During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded pain, and score of 0 was coded no pain, yielding one score for each participant's procedure."|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.|||Participants|||Number
2839663|NCT00187135|Primary|Pain(Yes/No)|"During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded pain, and score of 0 was coded no pain, yielding one score for each participant's procedure."|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.|||Participants|||Number
2839664|NCT00187096|Secondary|Overall Survival|"Overall survival is defined as the time relapse from on study date to death with those alive at last follow up date censored. The Kaplan-Meier method was used to compute survival probability estimates and confidence interval was determined by binomial distribution (for no events or all events) or by log hazard method. The binomial interval is based on the number of patients at risk.~The confidence intervals for Arm 1 and Arm 2a were determined by binomial distribution.~The confidence interval for Arm 2b was determined by log hazard method."|Up to 2 years post NK cell transplantation||||Percent probability||95% Confidence Interval|Number
2839665|NCT00187096|Secondary|Relapse-free Survival|For Arm 1, the efficacy of NK cell transplantation will be reported as the proportion of participants who achieve complete or partial remission. Kaplan-Meier estimates of relapse-free survival and confidence interval was determined by binomial distribution because no events were observed. The binomial interval is based on the number of patients at risk.|Up to 2 years post NK cell transplantation||||Percent probability||95% Confidence Interval|Number
2839666|NCT00187096|Secondary|Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)|NK cells in recipient achieving ability to lyse target cell line (K562) within normal range established by donor NK cells.|Days 2, 7, 14, 21, and 28 after NK cell transplantation|All 10 participants received NK donor cells; 9 of the 10 participants received KIR-mismatched NK donor cells.|||participants|||Number
2839667|NCT00187096|Secondary|Number of KIR-mismatched NK Cells|Number of KIR-mismatched donor NK cells in recipients' blood at day 2 and day 14 post NK cell infusion.|Day 2 and day 14 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.|||cells/µl||Full Range|Median
2839668|NCT00187096|Secondary|Day That Maximum NK Cell Engraftment Was Reached|The time elapsed after transplantation in days until peak KIR-mismatched donor NK cell expansion was reached in recipients|Day 0 through Day 28 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.|||number of days||Full Range|Median
2839878|NCT00183456|Primary|Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)|Number of participants that had 2 or more sex partners in the past 90 days.|6 months||||participants|||Number
2839670|NCT00187096|Secondary|Percent of Peak NK Cell Chimerism|The maximum percent of donor NK cell in recipients during a four-week period after NK cell infusion.|Days 2, 7, 14, 21 and 28 after NK cell transplantation|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.|||percent of NK cells||Full Range|Median
2839671|NCT00187096|Secondary|Duration of Engraftment of Natural Killer (NK) Cells|NK cell engraftment defined as NK cell chimerism in recipients.|Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.|||Days||Full Range|Median
2839672|NCT00187096|Primary|Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.|||proportion of patients|||Number
2839673|NCT00187096|Primary|Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.|||participants|||Number
2839674|NCT00186901|Secondary|Mean QCT Z-Score by Bsm 1 Vitamin D Receptor Genotype|The Bsm1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Bsm 1 vitamin D receptor, only 41 had the BB genotype, 65 had the Bb genotype, and 77 had the bb genotype.|||QCT Z-Score||Standard Deviation|Mean
2839675|NCT00186901|Secondary|Mean QCT Z-Score by Apa1 Vitamin D Receptor Genotype|The Apa1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Apa 1 vitamin D receptor, only 68 had the AA genotype, 104 had the Aa genotype, and 49 had the aa genotype.|||QCT Z-Score||Standard Deviation|Mean
2839676|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 180 patients were assessed at 36 months by the QCT method and 89 were evaluated using the DXA methods to assess Bone Mineral Density. 89 patients received both scans.|36 months|180 patients were assessed at the 36 months interval and received a QCT Scan. 89 patients were also assessed using the DEXA Scan. Comparison of the two methods produced 89 paired studies to arrive at a correlation.|||Z-score||Standard Deviation|Median
2839677|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 188 patients were assessed at 24 months by the QCT method and 90 were evaluated using the DXA methods to assess Bone Mineral Density. 90 patients received both scans.|24 months|188 patients were assessed at the 24 months interval and received a QCT Scan. 90 patients were also assessed using the DXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation.|||Z-score||Standard Deviation|Mean
2839678|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 218 patients were assessed at 12 months for QCT. 94 were evaluated using DXA. 94 patients received both scans.|12 months|218 patients were assessed at the 12 months interval and received a QCT Scan. 94 patients were also assessed using the DXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation.|||Z-score||Standard Deviation|Mean
2839679|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 121 patients at baseline were assessed by both method the QCT and DXA methods to assess Bone Mineral Density.|Baseline|275 patients were assessed at baseline and received a QCT Scan. 121 patients were also assessed using the DEXA Scan. Comparison of the two methods used 121 paired studies to arrive at a correlation coefficient.|||Z-score||Standard Deviation|Mean
2839680|NCT00186901|Primary|Bone Mineral Density by Age Group of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (age groups) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether age was a contributing factor in bone mineral density.|||Z-score||Standard Error|Median
2839681|NCT00186901|Primary|Bone Mineral Density by Race of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (race) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether race contributed to bone mineral density.|||Z-score||Standard Error|Median
2839682|NCT00186901|Primary|Bone Mineral Density in Male and Female ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (gender) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Baseline participants were assessed to determine whether gender was a pre-disposing factor for bone mineral density.|||Z-score||Standard Error|Median
2839766|NCT00185679|Secondary|Acute GvHD (Grade II-IV)|Number of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).|within 100 days post-transplant||||participants|||Number
2839683|NCT00186901|Primary|Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)|The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient's Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits.|Baseline, 12 months, 24 months, and at 36 months or study end|Of the 275 pts identified with BMD z-scores < 0, 134 were randomized to the placebo group and 141 to the supplement group. Bone Mineral Density QCT Z-scores were calculated at baseline, 12 months, 24 months, and at 36 months or study end.|||Z-Score||Full Range|Median
2839684|NCT00186888|Secondary|Mean Primary Visual Cortex Function: Maximum T-value|"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neurology, London). The maximum t-statistic in activated cluster (negative BOLD) is provided.~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time."|At diagnosis through 6 years after last patient enrollment||||Maximum t-statistic (negative BOLD)|Number of exams|Standard Deviation|Mean
2839685|NCT00186888|Post-Hoc|Number of Patients Recommended for and Utilizing Rehabilitation Services|"Participants were evaluated by Occupational Therapy at diagnosis, and at 3, 6, 9, and 12 months from diagnosis with a battery of standardized and non-standardized measures. Assessments including the Battelle Developmental Inventory, the Sensory Profile, the Oregon Project for Visually Impaired Preschoolers, Pediatric Evaluation of Disability Inventory, and the Greenspan Social Emotional Growth Scale were utilized for developing the participants plan of care and making referrals for services in the home community. Recommendations for rehabilitation services in the home community were made based on the results of the occupational therapists evaluation.~A subsequent review of February 2013 subgroup definitions resulted in the reclassification of evaluable participants and subgroups in May 2015. This reclassification applies to the data for this outcome only."|At diagnosis, and at 3, 6, 9, and 12 months from diagnosis|Objective was added after the protocol started. Due to the late start, 33 of the 105 overall participants were eligible. Of the 33, 1 family declined to participate; 1 was removed from the protocol, 5 were lost to follow-up, and 4 patients were unable to complete the developmental assessment. In total, 22 have complete data sets.|||participants|||Number
2839686|NCT00186888|Secondary|Mean Primary Visual Cortex Function: Cluster Size|"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neuology, London).~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time."|At diagnosis through 6 years after last patient enrollment||||number activated voxels (negative BOLD)|Number of exams|Standard Deviation|Mean
2839687|NCT00186888|Secondary|Change in Distortion Product Otoacoustic Emissions (DPOAEs)|For DP_amplitude to be considered valid, a baseline DP_SNR (Distortion Product for Signal-to-noise ratio) for each frequency (1000-8000 Hz) and for each ear (left and right) must be = 6 dB. Any ear with invalid amplitude at baseline for each frequency should be excluded. The DPOAEs amplitude levels were averaged across the right and left ears at each frequency in the patients exhibiting valid DPOAE amplitudes in both ears, resulting in mean DPOAE levels. Subsequently, comparisons between baseline and most recent evaluation (collapsed across ears) for each frequency were made to evaluate if a significant decrease in DPOAE amplitude exists between the two time points.|From Diagnosis through 5 years after completion of therapy|A total of 14 patients had “Incomplete data” and were not included in the analysis.|||dB||Standard Deviation|Mean
2839688|NCT00186888|Secondary|Number of Participants With Change in Size of Pineal Gland|The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in pineal gland size is reported here.|From diagnosis through 6 years after last patient enrollment|Pineal gland size was measured during routine MRI screening. Measurements were compared over time to quantify any change in size. Measurements were compared with standard pediatric norms to determine “prominence” or “mild enlargement” (subjective comparison).|||Participants|||Count of Participants
2839689|NCT00186888|Secondary|Number of Participants With Development of Pineal Cysts|The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in primary visual cortex function from diagnosis through 6 years after last patient enrollment is reported here.|At diagnosis through 6 years after last patient enrollment|A patient may be included in more than one category due to having more than one cyst.|||Participants|||Count of Participants
2839690|NCT00186888|Secondary|Assessment of School Readiness|The Bracken Basic Concepts Scale was used to assess school readiness. It is an examiner-administered measure that assesses per-academic skills including letter and number recognition, shapes, colors, and understanding of sizes and comparisons. Raw scores are converted into age-normed scaled scores (normative mean = 10, SD = 3) for the School Readiness Composite. Higher scores are indicative of stronger pre-academic skills, with scores from 7 to 13 within the Average range.|Patients were assessed at 5 years of age|All patients were included, regardless of treatment strata.|||units on a scale||Standard Deviation|Mean
2839728|NCT00186485|Secondary|Beck Depression Inventory Score; Baseline to End of Week 4|The Beck Depression Inventory Scale (BDI) measures the severity of depression based on the patients response to 21 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 3 (most severe); total scores range from 0 (no depressive symptoms), to 63 (very severe depression). A decrease in the score reflects a reduction of the severity of depression.The scores are from Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward|||units on a scale||Standard Deviation|Mean
2839691|NCT00186888|Secondary|Change in Parenting Stress Index (PSI)|The PSI is a commonly used measure of parenting stress. In 101 questions, the PSI delineates between stress as a function of child characteristics (e.g., adaptability, demandingness, mood; Child Domain) and stress as a function of parent characteristics (e.g., depression, sense of competence, social isolation; Parent Domain), as well as an overall stress score (Total Stress). Raw scores are calculated (normative means: Child Doman = 98.4; Parent Domain = 122.7; Total Stress Score = 221.1). This measure was given at all time points. Scores range from 131-320 for Total Stress, 69-188 for Parent Domain, and 50-145 for Child Domain, with higher scores indicative of greater stress (Total: >260; Parent: >153, Child: >122).|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
2839692|NCT00186888|Secondary|Change in Parent Report of Social-Emotional Factors|This outcome was measured using the Ages and Stages Questionnaire which is a parent-completed measure of a child's social-emotional functioning. Raw scores are calculated and compared to cut-off points by age (6 months = 45; 1 year = 48; 2 years = 50; 3 years = 59; 5 years =70). Higher scores are indicative of more problems with scores above the cut-off indicating significant concerns warranting additional follow-up. Possible scores range from 0 to 200+, depending on the number of items administered, which varies by the age of the child (19 to 33 items). However, the primary use of this tool is as a screener. Thus, typically, scores are interpreted as they compare to the identified cut-offs, with children who score above the cut-off referred for further evaluation. This measure was given at all time points.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
2839693|NCT00186888|Secondary|Change in Relevant Daily Living Skills|The Adaptive Behavior composite was measured using the Vineland Scales of Adaptive Behavior (VABS) which is an examiner-administered semi-structured interview that assesses adaptive functioning from birth through adulthood. Subscales including motor skills, communication, socialization, and daily living skills combine into an overall adaptive behavior composite which is an age-normed standard score (normative mean = 100, SD = 15). This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
2839694|NCT00186888|Secondary|Change in Cognitive Functioning|The Early Learning Composite was assessed with Mullen Scales of Early Learning, a measure of developmental functioning appropriate for use with children from birth through age 5. It is an examiner-administered instrument that uses toys, games, pictures, and other objects to elicit information about a child's language, fine and gross motor skills, and overall early learning capabilities. Raw scores are converted to an age-normed standard score (normative mean = 100, SD = 15) for the overall Early Learning Composite. This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry) and at ages 6 months, 1 year, 2 years, 3 years and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.|||units on a scale||Standard Deviation|Mean
2839695|NCT00186888|Secondary|Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma . The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.|||probability|Number of Eyes|95% Confidence Interval|Number
2839696|NCT00186888|Secondary|Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year event-free survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.|||probability|Eyes|95% Confidence Interval|Number
2839697|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed.For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.|||probability|Eyes|95% Confidence Interval|Number
2839698|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year event-free survival of the eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.|||probability|Number of Eyes|95% Confidence Interval|Number
2839699|NCT00186888|Secondary|Ocular Survival of Eyes of Stratum B Patients|"To estimate the 5-year ocular survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).|||probability|Eyes|95% Confidence Interval|Number
2839700|NCT00186888|Secondary|Event-free Survival of Eyes of Stratum B Patients|"To estimate the 5-year event-free survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).|||probability|Eyes|95% Confidence Interval|Number
2839701|NCT00186888|Secondary|Ocular Survival of Stratum A Patients|"To estimate the 5-year ocular survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.|||probability||95% Confidence Interval|Number
2839702|NCT00186888|Secondary|Event-free Survival of Stratum A Patients|"To estimate the 5-year event-free survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.|||probability||95% Confidence Interval|Number
2839703|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
2839704|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
2839705|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
2839706|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.||||||
2839707|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival of eye will be defined per eye as the time interval from date on study to date of enucleation or date of last follow-up. Ocular survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.|||probability|Eyes|95% Confidence Interval|Number
2839708|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free survival (EFS) of eyes of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year EFS."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.|||probability|Eyes|95% Confidence Interval|Number
2839709|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival"|From date on-study to an event or last follow-up|From the total of 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Thus, the Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.|||probability||95% Confidence Interval|Number
2839710|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free (EFS) survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|Of the total 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.|||probability||95% Confidence Interval|Number
2839711|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.~Only wild-type was present in BCRP 15994, therefore, statistical analysis was not done for these alleles."|||Liters/hour/m^2||95% Confidence Interval|Median
2839712|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.~Only wild-type was present in CYP3A5*6, therefore, statistical analysis was not done for these alleles."|||Liters/hour/m^2||95% Confidence Interval|Median
2839713|NCT00186888|Secondary|Stratum B Response Rate of Early Stage Eyes to Window Therapy|To estimate the proportion of early stage eyes defined as Reese-Ellsworth Group I, II, or III eyes, that responded to 2 courses of window therapy which consisted of vincristine and topotecan|Six weeks post window therapy.|Among the 27 stratum B patients with 54 eyes with retinoblastoma, 12 eyes were early stage (Reese-Ellsworth group I, II, or III). The remaining 42 eyes were advanced stage and were not included in this analysis.|||Participants|||Number
2839729|NCT00186485|Primary|Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4|The HDRS - 17 is a scale that measures the severity of depression based on the patients response to 17 questions on the presence and severity of the symptoms found in depression. The severity of a symptom is scored from 0 (not present) to 4 (most severe); total scores range from 0 (no depressive symptoms), to 68 (very severe depression). A decrease in the HDRS score reflects a reduction in depression severity.The scores are Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward|||units on a scale||Standard Deviation|Mean
2839714|NCT00186888|Primary|Stratum B Response to Window Therapy|The primary outcome is to estimate the proportion of stratum B patients responding to 2 courses of window therapy consisting of vincristine and topotecan. Complete Response is the complete regression of all apparent tumor masses in the funduscopic examination and by MRI and ultrasound (US). Partial Response is defined as greater than 50% (but less than 100%) reduction of the tumor masses in the funduscopic examination and by US and MRI, without the appearance of any new lesions. The response must persist for at least 4 weeks. Stratum A and C did not receive window therapy.|Six weeks post window therapy|The primary objective related to stratum B patients only, as these were the patients who were given window therapy consisting of 2 courses of vincristine and topotecan. Of the 27 stratum B patients enrolled, all were included in the analysis of the primary objective.|||Participants|||Number
2839715|NCT00186875|Other Pre-specified|Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)|The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives.|End of Block B therapy (Day 19)|Protocol information for the comparison group of TOTXV Participants, including Participant Flow, Baseline Characteristics, and Adverse Events, is available on ClinicalTrials.gov under registration ID NCT00137111.|||Participants|||Count of Participants
2839716|NCT00186875|Other Pre-specified|Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)|The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives.|End of Block Block C therapy (Day 46)|Protocol information for the comparison group of TOTXV Participants, including Participant Flow, Baseline Characteristics, and Adverse Events, is available on ClinicalTrials.gov under registration ID NCT00137111.|||Participants|||Count of Participants
2839717|NCT00186875|Primary|Overall Survival (OS)|OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given.|2 years after last patient completes therapy (approximately 4 years after enrollment)||||probability||Standard Deviation|Mean
2839718|NCT00186875|Primary|Response Rate|"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology."|End of re-induction Block C (approximately 1 month after the start of therapy)|Response is defined as morphological complete remission after re-induction Block C. Participants who begin re-induction phase but fail to reach the end of Block C for whatever reason will be regarded as an induction failure.|||proportion of participants|||Number
2839719|NCT00186628|Secondary|Overall Survival||4 years|35 total participants were analyzed. No data is available for the withdrawn participant.|||Percentage of participants by disease||95% Confidence Interval|Number
2839720|NCT00186628|Secondary|Mortality|Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse.|Day 100 and 1 year|35 total participants were analyzed. No data is available for the withdrawn participant.|||Participants|||Number
2839721|NCT00186628|Secondary|Incidence of Relapse|Subjects who Relapsed following after Allogeneic HSCT|4 years|35 total participants were analyzed. No data is available for the withdrawn participant.|||Participants|||Count of Participants
2839722|NCT00186628|Primary|Chronic Graft-vs-Host Disease (cGvHD)|The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)|4 years|35 total participants were analyzed. No data is available for the withdrawn participant.|||percentage of participants||95% Confidence Interval|Number
2839723|NCT00186537|Primary|Pre- and Post-Intervention HDL Cholesterol Levels|Compare the change in mean HDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|HDL Cholesterol|||mg/dL||Standard Deviation|Mean
2839724|NCT00186537|Primary|Pre- and Post-Intervention LDL Cholesterol Levels|Compare the change in mean LDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|LDL cholesterol|||mg/dL||Standard Deviation|Mean
2839725|NCT00186537|Primary|Pre- and Post-Intervention Triglyceride Levels|Compare the change in mean triglyceride levels between groups after the interventions|Baseline, 12 weeks|Triglycerides|||mg/dL||Standard Deviation|Mean
2839726|NCT00186498|Primary|Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.|The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function.|30 days|The subjects enrolled in the study had signed a consent to receive ECT treatment.|||units on a scale||Standard Deviation|Mean
2839727|NCT00186485|Secondary|Clinical Global Impression - Severity; Baseline to End of Week 4|The Clinical Global Impression of Severity (CGI-S) is a measure of depression severity and disability based on the clinicians overall impression of the severity of depression based on the patients response to open ended questions and self report of the presence and severity of the symptoms and level of disability found in depression. The CGI-S assesses the severity of illness (depression) and is scored from 1 (well, not at all ill) to 7 (among the most severely ill patients); a decrease in the CGI-S score reflects a reduction of the symptoms and disability due to depression. The scores are from Baseline and End of Week 4|4 weeks|Subjects received 4 weeks of right sided dorsolateral prefrontal cortex 1Hz TMS, last observation carried forward|||units on a scale||Standard Deviation|Mean
2839730|NCT00186446|Primary|Can Depression and Smoking Cessation be Treated Simultaneously|This was measured by the drop out rate during the study.|Dropouts over course of study|Number dropped out of the study|||Participants|||Count of Participants
2839731|NCT00186446|Primary|Cessation of Smoking|Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.|Week 10|Carbon monoxide levels available on 8 subjects at week 10.|||Participants|||Count of Participants
2839732|NCT00186446|Primary|Hamilton Depression Scale Score|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.|baseline to week 10|9 patients did not complete the study and we used last observation carried forward|||percentage of change in depression||Standard Deviation|Mean
2839733|NCT00186186|Secondary|Response to the Divalproex-ER in Acute Bipolar 2 Depression.|A reduction greater than or equal to 50% in MADRS total score from baseline to the endpoint.|7 weeks||||participants|||Number
2839734|NCT00186186|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|"The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.~Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression."|Baseline, 7 weeks||||units on a scale||Standard Deviation|Mean
2839735|NCT00186121|Secondary|Serious Adverse Events|The toxicity of the treatment regimen of goserelin followed by anastrozole is estimated by the rate of Serious Adverse Events (SAEs) that occurred during the course of the study.|6 months||||Serious Adverse Events (SAEs)|||Number
2839736|NCT00186121|Secondary|Estradiol Suppression|Plasma estradiol determinations were performed at baseline, 1 month, 3 months, and 6 months using the Coat-A-Count Estradiol competitive binding assay system, which has a calibrated range for estradiol of 20 to 3,600 pg/mL with an analytical sensitivity of 10 pg/mL.|6 months||||pg/mL estradiol||Standard Deviation|Mean
2839737|NCT00186121|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed as the median observed in the participants receiving goserelin followed by anastrozole.|up to 63 months||||months||Full Range|Median
2839738|NCT00186121|Secondary|Time-to-Progression (TTP)|"Time-to-progression (TTP) was assessed as the median observed in the participant group.~Progression of disease was considered, per protocol, to be ≤ 25% increase in the area of any malignant lesion greater than 2 square cm, or ≤ 25% increase in the sum of the products of the longest perpendicular diameters of individual lesions in a given organ, when compared to baseline values or after therapeutic response."|up to 63 months||||months||Full Range|Median
2839739|NCT00186121|Secondary|Response Rates|"The numbers of participants with metastatic breast cancer experiencing Complete Response (CR); Partial Response (PR); or Stable Disease (SD) after treatment with goserelin followed by anastrozole are reported.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~SD = No significant change in measurable or evaluable disease for at least 4 weeks.~All measurements by ruler or calipers."|6 months||||Participants|||Count of Participants
2839740|NCT00186121|Secondary|Clinical Benefit Rate|"The overall clinical benefit rate of goserelin followed by anastrozole was evaluated, as determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~SD = No significant change in measurable or evaluable disease for at least 4 weeks.~All measurements by ruler or calipers."|6 months||||percentage of participants||95% Confidence Interval|Number
2839741|NCT00186121|Primary|Objective Response Rate (ORR)|"ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.~CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.~PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion.~All measurements by ruler or calipers."|3 months||||percentage of participants||95% Confidence Interval|Number
2839742|NCT00186069|Secondary|Neonatal Apgar Score at 5 Minutes|The median Apgar score at 5 minutes. Apgar score scale is from 0 to 10 with score 0 expressing the worst neonatal status and score 10 the best status.|At 5 minutes after birth||||Apgar score||Full Range|Median
2839743|NCT00186069|Secondary|Gestational Age at Delivery (Weeks)|Median gestational age at delivery (in full weeks)|Time of delivery||||weeks of gestation||Full Range|Median
2839744|NCT00186069|Primary|Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours|The primary outcome was the proportion of women undelivered at 48 hours with resolution of vaginal bleeding and uterine contractions.|48 hours after the randomization||||participants|||Number
2839745|NCT00186056|Primary|Hamilton Depression Rating Scale|"Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).~Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline."|Baseline and Day 35 HAMD scores||||units on a scale||Standard Deviation|Mean
2839746|NCT00186043|Primary|Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)|"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|Week 8|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.|||percentage of participants|||Number
2839762|NCT00185731|Primary|Tumor Apoptosis|Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment|1 year|24 participants had tumors sampled for primary endpoint as per protocol. However, 1 withdrew, and only 22 of remaining participants had adequate tumor samples for analysis of apoptosis at baseline and at subsequent time points.|||Participants|||Count of Participants
2839763|NCT00185692|Secondary|Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant|GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant.|90 days||||Participants|||Count of Participants
2839767|NCT00185679|Primary|Neutrophil Engraftment|Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L|30 days post-transplant||||participants|||Number
2839747|NCT00186043|Secondary|Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores|MADRS assesses change from baseline to endpoint. Higher score indicates more severe depression; each item yields a score of 0 to 6. Overall score ranges: 0 to 60. Questions following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Cutoff points:0 to 6- normal/symptom absent; 7 to 19- mild depression; 20 to 34- moderate depression; >34- severe depression. YMRS:a 11-item clinician-admin instrument assesses severity of mania. Symptoms rated: Elevated mood, Increased motor activity/energy, Sexual interest, Sleep, irritability, Speech, language/thought disorder, Content, Disruptive/aggressive behavior, Appearance, Insight. Each composed of five explicitly defined levels of severity. Severity ratings based on patient's subjective report of clinical condition during past 48 hours and clinician's observations.|Baseline and 8 weeks|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.|||percentage of participants|||Number
2839748|NCT00186043|Primary|Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity|"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|Baseline and 8 weeks|One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.|||percentage of participants|||Number
2839749|NCT00186017|Secondary|Mean Change in Hamilton Anxiety Rating Scales (HAM-A)|"The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A does not provide any standardized probe questions. Despite this,the reported levels of interrater reliability for the scale appear to be acceptable.~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe."|Baseline, 1 Week||||units on a scale||Standard Deviation|Mean
2839750|NCT00186017|Secondary|Mean Change in MADRS After 1 Week of Treatment.|Montgomery-Asberg Depression Rating Scales (MADRS) is a multi-item clinician tool assessing depression. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.|Baseline, 1 week||||units on a scale||Standard Deviation|Mean
2839751|NCT00186017|Secondary|Mean Change in YMRS After 1 Week of Treatment|"The Young Mania Rating Scale (YMRS) scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Responses to each item are summed with a higher score indicating more mania symptoms endorsed.~Scale:0-60 0=Good 60=Bad"|Baseline, 1 week||||units on a scale||Standard Deviation|Mean
2839752|NCT00186017|Primary|Mean Change in CGI-BP-OS After 1 Week of Treatment|The Clinical Global Impression - bipolar version - overall severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not ill; 2, minimally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, very severely ill|Baseline, 1 Week||||units on a scale||Standard Deviation|Mean
2839753|NCT00185965|Primary|Objective Response Rate (ORR)|Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)|12 weeks||||percentage of treated subjects|||Number
2839754|NCT00185900|Secondary|Composite Neonatal Morbidity|Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.|From delivery until discharge from the hospital, up to 30 days of age|Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed.|||Participants|||Count of Participants
2839755|NCT00185900|Secondary|Serious Maternal Adverse Effect|A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.|From study enrollment until discharge from delivery hospital, up to 30 days after delivery.||||Participants|||Count of Participants
2839756|NCT00185900|Secondary|Neonatal Birth Weight|Presented as grams|Until delivery, up to 42 weeks of gestation|Data included twins, so the group totals are greater than seen in the Overall Number of Participants Analyzed|||grams||Standard Deviation|Mean
2839757|NCT00185900|Secondary|Gestational Age at Delivery|Presented as weeks|Until delivery, up to 42 weeks of gestation||||weeks||Standard Deviation|Mean
2839758|NCT00185900|Secondary|Time to Uterine Quiescence|Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.|Until delivery, up to 42 weeks of gestation||||hours||Standard Deviation|Mean
2839759|NCT00185900|Primary|Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence|Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.|48 hours after administration of study medication.||||Participants|||Count of Participants
2839760|NCT00185731|Secondary|Atorvastatin Toxicity|Assessed as the number of study participants with atorvastatin-related serious adverse events (SAEs).|1 year|All study participants who received atorvastatin|||Participants|||Count of Participants
2839761|NCT00185731|Secondary|Correlation of Tumor Apoptosis to Clinical Response|The validity of tumor apoptosis as a biologic endpoint was assessed by correlation to clinical response. A correlation substantially less than 1 is interpreted as a poor correlation, while a correlation near +1 or -1 is interpreted as a strong correlation.|1 year|24 participants had tumors sampled for primary endpoint as per protocol. However, 1 withdrew and 1 had an inadequate tumor samples for analysis, leaving only 22 remaining participants for analysis of apoptosis at baseline and at subsequent time points.|||Pearson Correlation Coefficient|||Number
2839768|NCT00185640|Secondary|Transplant-related Mortality|Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant.|1 year||||percentage of participants|||Number
2839772|NCT00185640|Secondary|Acute Graft vs Host Disease (GvHD), All Evaluable|"The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.~Skin manifestations Skin Stages~0: No rash~1: Maculopapular (MP) rash <25% of body surface area~2: MP rash on 25-50% of body surface area~3: Generalized erythroderma (ED)~4: Generalized ED with bullous formation and desquamation~Liver Stages (Bilirubin in mg/dL)~0: <2~1: 2-3~2: 3.01-6~3: 6.01-15.0~4: >15~Gastrointestinal (GI) Stages (diarrhea)~0: None or < 500 mL/day~1: 500-999 mL/day~2: 1000-1499 mL/day~3: >1500 mL/day~4: Severe abdominal pain, with or without ileus~Glucksberg Overall grade~Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.~Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80~Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60~Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40"|100 days post-transplant||||percentage of participants|||Number
2839773|NCT00185640|Primary|Acute Graft vs Host Disease (GvHD)|"The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages.~Skin manifestations Skin Stages~0: No rash~1: Maculopapular (MP) rash <25% of body surface area~2: MP rash on 25-50% of body surface area~3: Generalized erythroderma (ED)~4: Generalized ED with bullous formation and desquamation~Liver Stages (Bilirubin in mg/dL)~0: <2~1: 2-3~2: 3.01-6~3: 6.01-15.0~4: >15~Gastrointestinal (GI) Stages (diarrhea)~0: None or < 500 mL/day~1: 500-999 mL/day~2: 1000-1499 mL/day~3: >1500 mL/day~4: Severe abdominal pain, with or without ileus~Glucksberg Overall grade~Grade 1: Skin 1/2; GI 0; Liver 0; Karnofsky performance scale (KPS) 90-100%.~Grade 2: Skin 1-3; GI 1; Liver 1; KPS 70-80~Grade 2: Skin 2/3; GI 2/3; Liver 2-4; KPS 50-60~Grade 4: Skin 2-4; GI 2-4; Liver 2-4; KPS 30-40"|100 days post-transplant|Reports the incidence of Grades 2 to 4 acute GvHD, as observed for the initial 37 participants treated on this study, who constitute the Primary Analysis for the study. See linked citation Lowsky, et al. NEJM. 29Sep2005;353(13)1321-1331.|||percentage of participants|||Number
2839774|NCT00185614|Secondary|Chronic Graft-vs-Host-Disease (cGvHD)|"Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as Extensive cGvHD; cGvHD, Not Extensive; or No cGvHD, as determined by investigator judgement (no protocol-specified criteria)."|3 years|Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT.|||Participants|||Count of Participants
2839775|NCT00185614|Secondary|Acute Graft-vs-Host-Disease (aGvHD)|Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.|6 months|Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria).|||Participants|||Count of Participants
2839776|NCT00185614|Secondary|Overall Survival (OS)|Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.|3 years|"The outcome data are reported as the number of participants who could be documented as remaining alive through 3 years from the date of the last transplant, for the Auto-HCT only population, the Auto-HCT then Allo-HCT population, and the overall study population (ie, Auto-HCT only plus +Auto-HCT then Allo-HCT)."|||participants|||Number
2839777|NCT00185614|Secondary|Relapse Rate|Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase).|3 years|The outcome data are reported as the number of participants who relapse per criteria within 3 years.|||participants|||Number
2839778|NCT00185614|Primary|Event-free Survival (EFS)|"Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. Event was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years."|3 years|"The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the Auto-HCT only population, the Auto-HCT then Allo-HCT population, and the overall study population (ie, Auto-HCT only plus +Auto-HCT then Allo-HCT)."|||Participants|||Count of Participants
2839779|NCT00185588|Secondary|Time-to-Progression, Evaluable Patients|Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.|12 months|"Evaluable subset of subjects that terminated from the study due to disease progression (endpoint).~No participants were analyzed in the Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group because no evaluable participants progressed within 12 months."|||months||Full Range|Median
2839780|NCT00185588|Primary|Time-to-Treatment Failure (Intent-To-Treat Analysis)|"For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)."|12 months||||months||Full Range|Median
2839781|NCT00185458|Secondary|Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839782|NCT00185458|Secondary|Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839783|NCT00185458|Secondary|Climacteric Symptom 6: Breast Tension (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839784|NCT00185458|Secondary|Climacteric Symptom 5: Irritability (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839785|NCT00185458|Secondary|Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839786|NCT00185458|Secondary|Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839787|NCT00185458|Secondary|Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839788|NCT00185458|Secondary|Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839789|NCT00185458|Secondary|Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839790|NCT00185458|Secondary|Progestogenic Symptom 5: Edema (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839791|NCT00185458|Secondary|Progestogenic Symptom 4: Nausea (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839792|NCT00185458|Secondary|Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839793|NCT00185458|Secondary|Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839794|NCT00185458|Secondary|Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839795|NCT00185458|Secondary|Continuation Rates|Percentage of subjects continuing in the study at the given time points.|At entry, at 2 years, at 4 years|ITT. Kaplan-Meier estimator given.|||Percentage of participants continuing|||Number
2839796|NCT00185458|Secondary|Assessment of QOL as Measured by Women's Health Questionnaire|Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||score on a scale||Standard Deviation|Mean
2839797|NCT00185458|Primary|Percentage of Participants With Successful Treatment|"Definition of successful treatment:~Completion of HRT phase, and~Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and~The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT"|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects eligible for the HRT|||Percentage of participants with success|||Number
2839798|NCT00185458|Primary|Number of Spotting Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||Spotting days||Inter-Quartile Range|Median
2839799|NCT00185458|Primary|Number of Bleeding Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase|Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.|||Bleeding days||Inter-Quartile Range|Median
2839800|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 12|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 991 to day 1080|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
2839801|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 4|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 271 to day 360|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
2839802|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 3|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 181 to day 270|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
2839803|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 2|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 91 to day 180|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
2839804|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 1|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 1 to day 90|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.|||days||Standard Deviation|Mean
2839805|NCT00185380|Secondary|Number of Subjects With Total or Partial Expulsions|The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.|Up to 3 years|The analysis was performed on the FAS (all subjects who had an IUS inserted).|||participants|||Number
2839806|NCT00185380|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.|Up to 3 years|All randomized women with a successful insertion were analyzed according to the treatment actually received and were included in the FAS, which was the set used for all safety and efficacy analyses. The PPS was identical to the FAS.|||Number per 100 women years||95% Confidence Interval|Median
2839807|NCT00185211|Secondary|MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60|Two-timepoint percentage brain volume change was estimated with Structural Image Evaluation, using Normalisation, of Atrophy (SIENA) software. The measurements describe the percentage change from screening in brain volume at month 60.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available. There were several missing values in both treatment arms regarding the percentage brain volume change.|||Percentage of brain volume||Inter-Quartile Range|Median
2839808|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60|Absolute change of volume of black holes from screening MRI to month 60 was calculated as volume of black holes at month 60 minus volume of black holes at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.|||cubic millimeter||Inter-Quartile Range|Median
2839809|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60|Absolute change of T2 lesion volume from screening MRI to month 60 was calculated as T2 lesion volume at month 60 minus T2 lesion volume at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.|||cubic millimeter||Inter-Quartile Range|Median
2839810|NCT00185211|Secondary|MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60|Newly active lesions are defined as displaying either new Gadolinium (Gd)-enhancement on T1-weighted scans or non-enhancement on T1-weighted scan but new on T2-weighted scan. The numbers of newly active lesions on yearly MRI scans were summed up to the cumulative number.|up to 60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available.|||cumulative number of lesions||Inter-Quartile Range|Median
2839811|NCT00185211|Secondary|Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60|"The MSFC score consists of three sub-tests (Timed-25-Foot-Walk, 9-Hole-Peg-Test, 3 Paced Auditory Serial Addition Test [PASAT]). Standardized results (Z-scores) of the sub-tests and the overall MSFC Z-score as an average of the three Z-scores were derived using baseline data pooled over both treatment arms as reference population. Higher Z-scores reflect a better neurological status."|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MSFC results at month 60 available.|||Z-scores||Inter-Quartile Range|Median
2839896|NCT00183391|Secondary|SES (Hollingshead)|Measure of socioeconomic status, score calculated from averaging likert responses, lower = worse|up to 14 weeks|data not collected||||||
2839812|NCT00185211|Secondary|Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate|The annualized relapse rate is defined as total number of relapses up to month 60 divided by the total observation time (last clinical visit minus first day of study treatment administration plus 1 of all participants) in years.|up to 60 months after start of treatment|The analysis followed the ITT principle. For each treatment arm, the relapse rate is defined as total number of relapses up to month 60 divided by the total observation time in years.|||number of relapses per patient and year||95% Confidence Interval|Mean
2839813|NCT00185211|Secondary|Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses|A relapse was defined as the appearance of a new neurological abnormality or the reappearance of a neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The time to the onset of recurrent relapses was determined for each subject according to the counting process representation for recurrent events. Time to a relapse was right-censored if a relapse-risk period ended without relapse. Based on the Andersen-Gill model the hazard ratio for recurrent relapses was estimated. Annualized relapse rates are provided as another outcome measure.|up to 60 months after start of treatment|The analysis followed the Intention-To-Treat (ITT) principle. The hazard for recurrent relapses was modelled by an extension of the Cox Proportional Hazards (PH) regression model (Andersen-Gill Model).|||Ratio|||Number
2839814|NCT00185211|Secondary|Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria|MS according to the criteria by McDonald was reached if, in addition to the single clinical demyelinating event, both dissemination in space and dissemination in time were established by MRI-criteria or a new relapse. Time to McDonald MS is the difference of date of McDonald MS to the date of Day 1 + 1. For subjects without McDonald MS, time to McDonald MS is the difference from the maximum (date of last magnetic resonance imaging scan, date of last clinical visit) to the date of Day 1 + 1 (right-censored observation).|up to 60 months after start of treatment|The analysis followed the ITT principle. After five years, in the initial placebo arm 151 participants and in the initial IFNB-1b arm 224 participants had reached McDonald MS diagnosis.|||months||95% Confidence Interval|Median
2839815|NCT00185211|Primary|Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60|As an index of health related quality of life in people diagnosed with MS, the FAMS Trial Outcome Index covers overall physical health (sum of sub-scale scores Mobility, Symptoms, Thinking/Fatigue, Additional Concerns) with a score range from 0 to 148. A higher score reflects a higher overall physical health as reported by patients.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients who completed the follow-up study could be included at month 60 as subject to copyright constraints and to the availability of validated language versions, FAMS assessments could not be conducted in all patients.|||units on a scale||Inter-Quartile Range|Median
2839816|NCT00185211|Primary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time|"EDSS progression was defined as an increase in the expanded disability status scale (EDSS) of 1.0 point compared to the lowest EDSS score obtained during the screening or baseline visit, if this score was &lt;= 5.5. A confirmed EDSS progression status was defined as an EDSS progression observed at two consecutive scheduled visits at least 140 days apart from each other. The EDSS scale is a method of quantifying disability in multiple sclerosis in eight functional systems and values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on a scale."|up to 60 months after start of treatment|The analysis followed the ITT principle. The 25%-percentile for time to confirmed EDSS progression was 908 days in the initial placebo arm but was not estimable in the initial IFNB-1b arm. After five years, in the initial placebo arm 47 participants and in the initial IFNB-1b arm 65 participants had reached confirmed EDSS progression.|||percentage of particip. with EDSS progr.|||Number
2839817|NCT00185211|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time|"CDMS could be reached due to a qualifying relapse or sustained progression of 1.5 points on the expanded disability status scale (EDSS) as compared to the lowest EDSS obtained during screening or Day 1. The validity of CDMS diagnoses was confirmed by a central committee. The EDSS scale quantifies disability in MS in 8 functional systems, values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on an ordinal scale. Time to CDMS = date of CDMS - date of Day 1 + 1 or time to CDMS = date of last clinical visit - date of Day 1 + 1 (right-censored)"|up to 60 months after start of treatment|The analysis followed the intention to treat (ITT) principle. After five years, in the initial placebo arm 94 participants and in the initial IFNB-1b arm 124 participants had reached CDMS diagnosis.|||cum. percentage of particip. with CDMS|||Number
2839818|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 4 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-208|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Subjects|||Number
2839819|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 5 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-260|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Subjects|||Number
2839897|NCT00183391|Secondary|Vital Signs - Pulse|Heartbeats per minute. Range varies from 50-205 depending on age and level of activity.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||beats per minute||Standard Deviation|Mean
2839820|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||years||Standard Deviation|Mean
2839821|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks - Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||years||Standard Deviation|Mean
2839822|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2839823|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2839824|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
2839825|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity|||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
2839826|NCT00184600|Secondary|Number of Participants Having an 'Other' Adverse Event||Up to month 37 (36 months of treatment plus 1 month follow-up)|Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).|||participants|||Number
2839827|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||units on a scale||95% Confidence Interval|Mean
2839828|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||units on a scale||95% Confidence Interval|Mean
2839829|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||mg/dL||Standard Deviation|Mean
2839830|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||mg/dL||Standard Deviation|Mean
2839831|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 36||Week 0 (baseline), month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||kilograms||Standard Deviation|Mean
2839832|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 12||Week 0 (baseline), month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||kilogram||Standard Deviation|Mean
2839833|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 36|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
2839834|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 12|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
2839835|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
2839836|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
2839837|NCT00184600|Secondary|Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%|Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
2839838|NCT00184600|Secondary|Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%|Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage of participants|||Number
2839898|NCT00183391|Secondary|Vital Signs - Diastolic Blood Pressure|Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg|up to 14 weeks|see participant flow section for participants that did not complete blocks|||mm HG||Standard Deviation|Mean
2839839|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 36|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
2839840|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 12|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
2839841|NCT00184548|Secondary|Number of Units of All Allogeneic Transfusions From Time of First Dose|The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set, including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Units of allogeneic transfusions||Standard Deviation|Mean
2839842|NCT00184548|Secondary|Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury|The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Participants|||Number
2839843|NCT00184548|Secondary|Number of Units of Transfused Red Blood Cells From Time of First Dose|The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Units of transfused red blood cells||Standard Deviation|Mean
2839844|NCT00184548|Secondary|Time to Death From Time of First Dose|The time of first dose refers to the time of the first dose of rFVIIa or placebo.|from day 0 to day 30|There is no measure summary for time to event type of endpoint as this would be a Kaplan-Meier graph.||||||
2839845|NCT00184548|Secondary|Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention|The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.|from day 0 to day 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Days||Standard Deviation|Mean
2839846|NCT00184548|Primary|Morbidity|Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.|from day 0 to day 30|Blunt trauma patient population: According to protocol, morbidity is not part of the primary endpoint since non-inferiority test of mortality was not passed. Penetrating Trauma patient population: No analysis done due to low statistical power.||||||
2839847|NCT00184548|Primary|Mortality|Number of participants to die from day 0 to day 30 from all causes.|from day 0 to 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Patients who discontinued (withdrawn or lost to follow up) before day 30 were excluded from analyses. Penetrating Trauma patient population: No analysis done due to low statistical power.|||Participants|||Number
2839848|NCT00184093|Secondary|Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|"Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.~Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.~Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline."|Baseline to response (up to 24 months)||||Participants|||Count of Participants
2839849|NCT00184093|Primary|Toxicity (Number of Participants With Serious Adverse Events)|Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)|Every 3 weeks from start of study until 30 days after the last dose of treatment||||Participants|||Count of Participants
2839850|NCT00184054|Secondary|Number of Participants With Severe (Grades 3-5) Adverse Events|Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.|Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy)||||Participants|||Number
2839851|NCT00184054|Primary|Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi)|Complete Remission (CR): ANC >=1000/mcl, Platelet count >=100,000/mcl, Bone marrow <5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response.|Up to 1 year|All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response.|||participants|||Number
2839852|NCT00184028|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|At end of every cycle|All participants who started treatment|||Participants|||Number
2839899|NCT00183391|Secondary|Vital Signs - Systolic Blood Pressure|Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg|up to 14 weeks|see participant flow section for participants that did not complete blocks|||mm HG||Standard Deviation|Mean
2839853|NCT00184028|Primary|Tumor Response|"All eligible patients who received the first dose of Taxotere will be included in the analysis.~Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease.~Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 months after the last subject enrolled has gone off study||||Participants|||Number
2839854|NCT00184002|Secondary|Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability|Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.|At end of every cycle||||Participants|||Count of Participants
2839855|NCT00184002|Primary|Percentage of Patients With Complete Response to the Combination Chemotherapy|"Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.~Response to the study treatment will be determined according to the criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al (23)."|At completion of cycle 4, 6, and 8||||Percentage of participants|||Number
2839856|NCT00183963|Secondary|Number of Participants With Changes in Mammographic Density|The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.||||||
2839857|NCT00183963|Primary|Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment|Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.||||||
2839858|NCT00183872|Secondary|Progression Free Survival|Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause. If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.|every 2 cycles|Population analyzed included all participants who received at least 6 weeks of treatment (or who were discontinued due to progressive disease or for reason of toxicity within the first 6 weeks of study). Two subjects had no tumor evaluation and follow up data available. Analysis was per protocol.|||Months||95% Confidence Interval|Median
2839859|NCT00183872|Primary|Objective Response (Complete, Partial, Stable and Progression)|Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.|every 2 cycles|Population analyzed included all participants who received at least 6 weeks of treatment (or who were discontinued due to progressive disease or for reason of toxicity within the first 6 weeks of study). Two subjects had no tumor evaluation and follow up data available. Analysis was per protocol.|||participants|||Number
2839860|NCT00183794|Secondary|Median Time to Progression (Months)|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)|6 months after enrollment of last patient|All participants who receive the first course of treatment are included in the summary of PFS.|||Months||Full Range|Median
2839861|NCT00183794|Primary|Tumor Response Type: CR, PR, SD or PD|Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.|6 months after enrollment of last participant|Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.|||Participants|||Number
2839862|NCT00183729|Secondary|Functional Recovery|Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)|week 0, week 12|intent to treat analysis; data presented are the week 12 data from the mixed effect model|||units on a scale||Standard Error|Least Squares Mean
2839863|NCT00183729|Secondary|Incidence of Major Depressive Disorder|cumulative incidence over 12 weeks of follow-up|week 12||||Participants|||Count of Participants
2839864|NCT00183729|Primary|Depressive Symptoms|Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)|week 0, week 12||||units on a scale||Standard Deviation|Mean
2839865|NCT00183677|Primary|Responder and Remission Status (%), Based on the Depression Rating Scale Score|The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as > 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score < 8 at endpoint (week 12 visit).|Measured at Week 12|97 patients with MDD (42 Female) enrolled in the 12 week study, 53 patients (27 Female) completed. Only completers were included in the primary outcome measure.|||participants|||Number
2839951|NCT00182689|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0 - 2 years||||months||95% Confidence Interval|Median
2839879|NCT00183443|Secondary|Social and Occupational Functioning Assessment Scale (SOFAS)|The Social and Occupational Functioning Assessment Scale (SOFAS) provides a rating of global social and occupational function independent of clinical symptoms. SOFAS is provided in the Diagnostic and Statistical Manual (DSM-IV) as an Axis V measure. The SOFAS is a global rating of current functioning, which is scored positively on a scale from 0 to 100. Higher scores represent higher levels of functioning. This instrument is a one-item rating of consumer functioning.|Week 12||||units on a scale||Standard Deviation|Mean
2839880|NCT00183443|Secondary|Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).|Week 12||||units on a scale||Standard Deviation|Mean
2839881|NCT00183443|Secondary|Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)|The Clinical Global Impression (CGI) rating scale was modified by Spearing and colleagues (1997) for use in bipolar disorder. CGI scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The revised CGI-Bipolar Version (CGI-BP) is effective in rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. The CGI-BP is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal, not ill) to 7 (very severely ill). Each component of the CGI is rated separately; the instrument does not yield a global score. Only severity of illness scores are reported. Increased scores represent increased illness severity|Week 12||||units on a scale||Standard Deviation|Mean
2839882|NCT00183443|Secondary|Hamilton Rating Scale for Depression (HAM-D,17)|The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The 17-item Likert-type scale (range 0-50) includes eight questions with a 5-point scale (ranging from 0=not present to 4=severe) and nine items scored from 0 to 2. Higher scores indicate increased depression severity. The total sum of these 17 answers is used to arrive at the final score: normal (0-7), mild (8-13), moderate (14-18), severe (19-22), or very severe (>=23).|Week 12||||units on a scale||Standard Deviation|Mean
2839883|NCT00183443|Primary|Symptoms of Mania, as Measured by Young Mania Rating Scale|Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
2839884|NCT00183430|Primary|Change in Sleep Assessed by the Pittsburgh Sleep Quality Index|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.|||Units on a Scale||Standard Deviation|Mean
2839885|NCT00183430|Primary|Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS|"Item B-2 recurrent distressing dreams of the event is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8."|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 4.|||Units on a Scale||Standard Deviation|Mean
2839886|NCT00183430|Primary|Clinical Global Impression of Change|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.|||Units on a Scale||Standard Deviation|Mean
2839887|NCT00183391|Secondary|HALP Rebound Effects Questionnaire|Questionnaire, qualitative assesses symptoms of rebound (moodiness, irritability, aggression, and ADHD symptoms) when the medication wears off at night.|up to 14 weeks|data not collected||||||
2839888|NCT00183391|Secondary|Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire|Questionnaire, qualitative designed to collect family history, prenatal environmental influences, and developmental history.|Measured at screening|data not collected||||||
2839889|NCT00183391|Secondary|Sleep Logs|Questionnaire, qualitative|Measured daily throughout the study|data not collected||||||
2839890|NCT00183391|Secondary|Actigraphy|Measure of physical activity|Measured daily throughout the study|data not collected||||||
2839891|NCT00183391|Secondary|Permanent Mathematics Product Test (PERMP)|Measure of fluency in performance of simple mathematics, sum, lower = worse|up to 14 weeks|data not collected||||||
2839892|NCT00183391|Secondary|Social Skills Rating Scale (SSRS)- Teacher Version|Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.|up to 14 weeks|data not collected||||||
2839893|NCT00183391|Secondary|Child Behavior Checklist (CBCL)|CBCL Total Score, measure of psychosocial problems, higher is worse.|Measured at screening|data not collected||||||
2839894|NCT00183391|Secondary|Conners Teacher Rating Scale- Short|Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse|up to 14 weeks|data not collected||||||
2839895|NCT00183391|Secondary|Conners-Wells Adolescent Self Report|Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse|up to 14 weeks|data not collected||||||
2839900|NCT00183391|Secondary|Tics: Total Impairment|Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839901|NCT00183391|Secondary|Tics: Total Phonic|Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839902|NCT00183391|Secondary|Tics: Total Motor|Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839903|NCT00183391|Secondary|Assessment of Affective Range (AAR)|Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839904|NCT00183391|Secondary|Children's Sleep Questionnaire|Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839905|NCT00183391|Secondary|Continuous Performance Test (CPT)|CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||T-scores||Standard Deviation|Mean
2839906|NCT00183391|Secondary|Child Conflict Index (CCI)|Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839907|NCT00183391|Secondary|Social Skills Rating Scale (SSRS)- Parent Version|Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||t-score||Standard Deviation|Mean
2839908|NCT00183391|Secondary|Clinical Global Impressions (CGI)- Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839909|NCT00183391|Secondary|ADHD-RS Inattention|Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839910|NCT00183391|Secondary|ADHD - H/I|Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839911|NCT00183391|Secondary|Treatment Preference Survey||Measured at ends of treatments one and two||||percentage of participants|||Number
2839912|NCT00183391|Primary|ADHD-RS Total Score|ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis.|up to 14 weeks|see participant flow section for participants that did not complete blocks|||units on a scale||Standard Deviation|Mean
2839913|NCT00183339|Secondary|Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)|The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score > or = to 18 is generally considered clinically significant.|12 months||||units on a scale||Standard Deviation|Mean
2839914|NCT00183339|Secondary|Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire|This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.|12 months||||units on a scale||Standard Deviation|Mean
2839915|NCT00183339|Secondary|Rate of Attrition|The percentage of participants who discontinued treatment prior to completion of the 12 month study|Measured at Month 12||||percent of group that discontinued early|||Number
2839916|NCT00183339|Primary|Rate of Recruitment|In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment* 2sites ) /[ # participants randomized ] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.|19 months||||months/participant at 1 site|||Number
2839917|NCT00183274|Secondary|Clinical Global Impressions, Severity of Illness|"The CGI provides an overall clinician-determined summary measure that takes into account a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.~The CGI is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~Results of the Placebo After Placebo group in Phase 3 were not entered due to sample size limitations."|Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)|The primary efficacy analytic method was time to relapse analyses estimated using a discrete time Cox proportional hazards model.Chisquare analyses were used to contrast relapse or responder rates. In the case of small cell sizes, Fisher exact test replaced chisquare analysis.|||Severity Score||Standard Deviation|Mean
2839918|NCT00183274|Primary|Hamilton Rating Scale for Anxiety|"Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe."|Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)|The primary efficacy analytic method was time-to-relapse analyses estimated using a discrete-time Cox proportional hazards model.|||HAM-A Rating Score||Standard Deviation|Mean
2839919|NCT00183248|Secondary|Number of Graft-versus-host Disease (GVHD) Events|A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease.|Three years post kidney transplant|Intent-to-Treat|||GVHD Events|||Number
2839920|NCT00183248|Secondary|Number of Chronic Allograft Nephropathies|"Number of chronic allograft nephropathies[1,2,3] at 3 years post kidney transplant.~Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater[2] with higher numeric scores indicating more severe nephropathy~The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification[3]~Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced nephropathies|||Nephropathy Events|||Number
2839921|NCT00183248|Secondary|Number of Kidney Biopsy-proven Acute Rejection|"Biopsy-proven acute renal (kidney) rejection[1,2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced an acute rejection|||Rejection Events|||Number
2839922|NCT00183248|Secondary|Graft Survival at Three Years Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at three years post-transplant~[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|Three years post kidney transplant|Intent-to-Treat|||participants|||Number
2839923|NCT00183248|Secondary|Participant Survival at Three Years Post Kidney Transplant||Three years post kidney transplant|Intent-to-Treat|||participants|||Number
2839924|NCT00183248|Primary|Overall Kidney Graft Survival at One Year Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at one year post-transplant~[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|One year post kidney transplant|Intent-to-treat|||participants|||Number
2839925|NCT00183248|Primary|Overall Participant Survival at One Year Post Kidney Transplant||One year post kidney transplant|Intent-to-Treat|||participants|||Number
2839926|NCT00183196|Primary|Time to Relapse to Drinking|Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.|16 weeks|Subjects who entered the analysis were all people with any drinking data post randomization. There was 2 people in naltrexone plus gabapentin, 1 person in naltrexone alone and 1 person in placebo group that had no post-randomization drinking data and were therefore not included in the intent to treat analysis presented.|||days||Standard Error|Mean
2839927|NCT00183092|Secondary|Change in Semantic Verbal Fluency (Naming Animals)|Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (naming animals) is semantic. Higher scores indicate better cognition.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at month 2 visit.|||number of words generated||Full Range|Mean
2839928|NCT00183092|Secondary|"Change in Phonemic Fluency (Words Beginning With Letter D)"|"Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (words beginning with letter D) is phonemic. Higher scores indicate better cognition."|Baseline, 2 months|Subject still alive and able to tolerate cognitive testing at month 2 visit|||number of words generated||Full Range|Mean
2839929|NCT00183092|Secondary|ADAS-Cog Change After 2 Months Among Survivors|ADAS-cog measures cognitive performance by combining ratings of 11 components (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering instruction, spoken language, word finding, comprehension) representing six areas of cognition: memory; language; orientation to time, place and person; construction of simple designs and planning; and performing simple behaviors in pursuit of a basic, predefined goal. Seven components are scored as the 'number incorrect'. For example, in the commands component, the number of five commands performed incorrectly (range: 0-5). Four components are scored from 0 (no limitations) to 5 (max limitations) as the examiner's perception of remembering instructions, spoken language ability, word finding and comprehension. Component scores are summed into a total ADAS-cog score ranging from 0-75, with low scores indicating better cognitive performance.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at Month 2 visit.|||units on a scale||Full Range|Mean
2839930|NCT00183092|Secondary|Change in Rankin Score After 2 Months|"The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. For subjects unable to return for the 2-month visit, Rankin score was assessed via telephone."|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone|||units on a scale||Full Range|Mean
2839931|NCT00183092|Secondary|Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months|Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB). The CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The global CDR score is computed via an algorithm. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. A higher value and/or positive change is worse. For subjects unable to return for month-2 visit, CDRS-SB was performed via telephone.|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone|||units on a scale||Full Range|Mean
2839932|NCT00183092|Secondary|Barthel Score Change After 2 Months|An ordinal scale used to measure performance in activities of daily living. Scores range from 0 (worst, fully dependent) to 100 (best, independent); higher score associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. 10 individual items are scored and summed to derive the overall Barthel index score. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The amount of time and physical assistance required to perform each item are considered in scoring each item. For subjects unable to return for month-2 visit, Barthel Index was performed via telephone.|baseline, 2 months|One surviving subject in the quinacrine arm did not attend the 2-month visit and was lost-to-followup; for a second surviving subject in the quinacrine arm, the Barthel Index was inadvertently not performed at the 2-month visit.|||units on a scale||Full Range|Mean
2839933|NCT00183092|Secondary|Change in Mini-Mental State Examination (MMSE) After 2 Months|The mini-mental state examination (MMSE) is a brief 30-point questionnaire that is used to screen for cognitive impairment. In about 10 minutes it samples functions including arithmetic, memory and orientation. A score greater than or equal to 25 points (out of 30) indicates a normal cognition. Lower scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment. Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing.|Baseline to Month-2|Subjects still alive, who attended the month-2 visit and were willing and able to tolerate cognitive testing. 1 subject in each arm did attend the 2-month visit but did not cooperate fully with the MMSE, which was therefore not scored.|||units on a scale||Full Range|Mean
2839934|NCT00183092|Primary|Primary Survival|Participants alive after 2 months on study treatment|Randomization to Month-2||||participants|||Number
2839935|NCT00182793|Primary|5-Year Overall Survival Rate|Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up|From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.|Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.|||percentage of participants||95% Confidence Interval|Median
2839936|NCT00182793|Primary|5-Year Relapse-free Survival Rate|Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.|From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment|Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.|||percentage of participants||95% Confidence Interval|Median
2839967|NCT00182091|Secondary|Change in Visceral Abdominal Adipose Tissue|Change in visceral abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||millimeters squared||Standard Deviation|Mean
2839937|NCT00182767|Primary|Maximum Tolerated Dose|The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details|Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD).|The phase I component of the study included 30 patients with breast and ovarian cancer.|||mg/m2|||Number
2839938|NCT00182767|Secondary|Progression-free Survival|We will summarize progression-free survival by Kaplan-Meier survival analysis.|The time from start of treatment to time of progression or death, assessed up to 2 years||||months||95% Confidence Interval|Median
2839939|NCT00182767|Secondary|Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)||Up to 2 years||||participants|||Number
2839940|NCT00182767|Primary|Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I)|Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities|28 days||||participants|||Number
2839941|NCT00182754|Secondary|Average Quality-of-life|Quality of life will be recorded and analyzed in a descriptive, exploratory fashion. We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites. The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo. Quality of life scores from the CLDQ will be summed for all patients on a monthly basis. Again we anticipate high patient drop out rates over time within these two cohorts. With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';|Up to 2 years||||QOL score||Full Range|Median
2839942|NCT00182754|Secondary|Number of Paracenteses|We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.|Up to 2 years||||number of paracenteses per patient||Full Range|Median
2839943|NCT00182754|Primary|Median Time to Paracentesis|Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.|Up to 2 years||||days||Full Range|Median
2839944|NCT00182728|Secondary|Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT||3 months|No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.||||||
2839945|NCT00182728|Secondary|Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT||3 months|No data were collected for this biomarker. Although samples were obtained from patients, they were never processed and analyzed.||||||
2839946|NCT00182728|Secondary|Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT||3 months|No data were collected for any of these biomarkers. Although samples were obtained from patients, they were never processed and analyzed.||||||
2839947|NCT00182728|Primary|Ipsilateral Breast Recurrence|Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).|5 years|"There were 71 patients who received IORT. Of those 71 patients, 18 received further local therapy due to high risk pathology. The results include the 53 patients who received IORT without further local therapy."|||percentage of participants||95% Confidence Interval|Number
2839948|NCT00182728|Primary|Incidence of Grade 3/4 Toxicity|"Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline:~Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event"|3 months||||Participants|||Count of Participants
2839949|NCT00182728|Primary|Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients|"Rates of good/excellent cosmesis was evaluated using the following criteria:~Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.~Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape."|1 year follow up visit|Patients who received IORT alone. 42 patients assessed their cosmetic outcome.|||Participants|||Count of Participants
2839950|NCT00182728|Primary|Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician|"Rates of good/excellent cosmesis was evaluated using the following criteria:~Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.~Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape."|1 year follow up visit|Patients who received intraoperative radiation therapy (IORT) alone. 56 patients were assessed.|||Participants|||Count of Participants
2839952|NCT00182689|Primary|Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|8 weeks to 2 years|All eligible patients who received treatment were included in this measure.|||percentage of participants||95% Confidence Interval|Number
2839953|NCT00182689|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after completion of every 28-day cycle.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
2839954|NCT00182637|Secondary|Toxicity||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.||||||
2839955|NCT00182637|Secondary|Time to Progression||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.||||||
2839956|NCT00182637|Primary|Overall Response Rate After 2 Courses of Treatment||2 months|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.||||||
2839957|NCT00182325|Primary|Helped me Remember Appointments|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839958|NCT00182325|Primary|Helped me Make Decisions|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839959|NCT00182325|Primary|Helped me Understand Tests|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839960|NCT00182325|Primary|Helped me Learn About Risks|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839961|NCT00182325|Primary|Helped me Stay Healthy|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839962|NCT00182325|Primary|Easy to Find Information|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839963|NCT00182325|Primary|Learned Something New|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839964|NCT00182325|Primary|Information Easy to Understand|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839965|NCT00182325|Primary|Easy to Log on|Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.|11 months|The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.|||score on a scale||Standard Deviation|Mean
2839966|NCT00182325|Primary|Uptake of Service|Number of log-ins|11 months|An intention-to-treat analysis was conducted. Participants were included in the analysis that started or completed the survey and excludes participants that were lost to follow-up or had a miscarriage.Intervention group: 63 completed survey + 22 partially complete survey =85). Control group: 53 completed survey + 43 partially complete survey = 96).|||Log-ins||Standard Deviation|Mean
2839968|NCT00182091|Secondary|Change in Total Abdominal Adipose Tissue|Change in total abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||millimeters squared||Standard Deviation|Mean
2839969|NCT00182091|Secondary|Change in Total Fat Mass|Change in total fat mass in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||kilograms||Standard Deviation|Mean
2839970|NCT00182091|Primary|Change in High-sensitivity C-reactive Protein|Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.|||mg/liter||Standard Deviation|Mean
2839971|NCT00182078|Primary|Diagnostic Interview for Children and Adolescents (DICA) - Child|The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.|||units on a scale||Standard Deviation|Mean
2839972|NCT00182078|Secondary|The Child Depression Inventory (CDI)|The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined.|Baseline to Week 12|Intention to treat (ITT). Analysis was conducted on participants with available data.|||units on a scale||Standard Deviation|Mean
2839973|NCT00182078|Primary|Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent|The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.|||units on a scale||Standard Deviation|Mean
2839974|NCT00182000|Secondary|Disability Inventory||Post-treatment (week 5)|||||||
2839975|NCT00182000|Secondary|Short-Form Health Survey (SF-36)||Post-treatment (week 5)|||||||
2839976|NCT00182000|Secondary|Obsessional Beliefs Questionnaire (OBQ)||Post-treatment (week 5)|||||||
2839977|NCT00182000|Secondary|Beck Anxiety Inventory (BAI)||Post-treatment (week 5)|||||||
2839978|NCT00182000|Secondary|Beck Depression Inventory (BDI)||Post-treatment (week 5)|||||||
2839979|NCT00182000|Secondary|Clinical Global Impressions Scale (CGI)||Post-treatment (week 5)|||||||
2839980|NCT00182000|Primary|Yale-Brown Obsessive Compulsive Scale (YBOCS)|A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).|Post-treatment (week 5)|Thirty-three participants were enrolled. Four participants decided not to participate in between enrolling and beginning treatment. Six participants withdrew from the study before the mid-treatment evaluation; 1 participant withdrew from the study after the mid-treatment evaluation, and this participant's data was carried forward.|||units on a scale||Standard Deviation|Mean
2839981|NCT00181961|Primary|Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores|"Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24~*One item on the measure is for men only~A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction."|baseline to endpoint (8 weeks)||||score on a scale||Standard Deviation|Mean
2839982|NCT00181883|Primary|Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score|The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.|Baseline to 8 weeks||||Units on a scale||Standard Deviation|Mean
2839983|NCT00181844|Primary|Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)|Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.|baseline to 12 weeks||||Units on a scale||Standard Deviation|Mean
2839984|NCT00181766|Primary|The Adult AISRS|The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.|baseline and 6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.|||scores on a scale||Standard Deviation|Mean
2839985|NCT00181766|Primary|ADHD-Clinical Global Impression|The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.|6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.|||subjects|||Number
2839986|NCT00181714|Primary|Cigarette Smoking|Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)|24 months|Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months|||percent|||Number
2839987|NCT00181623|Secondary|Breast Milk Prolactin Levels|Treatment group|28 days||||mcg/L||Standard Error|Mean
2839988|NCT00181623|Primary|Breast Milk Production|Treatment group|28 days|One subject did not qualify after screening.|||mL/day||Standard Error|Mean
2839989|NCT00181610|Secondary|Breast Milk Prolactin Levels||7 days||||mcg/L||Standard Error|Mean
2839990|NCT00181610|Primary|Change in Breast Milk Volume Baseline to 7 Days||7 days||||% change from baseline||Standard Error|Mean
2839991|NCT00181363|Primary|Dose Homogeneity 3: V95 %|PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position|1 day after treatment planning|To investigate dose homogeneity V105% (volume of tissue receiving more than 105% of the prescribed dose) and V107% (volume of tissue receiving more than 107% of the prescribed dose) were calculated for prone position versus supine position.|||cc||Standard Deviation|Mean
2839992|NCT00181363|Secondary|PTV Coverage in Organs at Risk: Heart V30|Doses in organs at risk: heart V30: the volumes (%) of the heart that received >= 30Gy|during treatment planning||||percentage of V30||Standard Deviation|Mean
2839993|NCT00181363|Secondary|PTV Coverage in Organs at Risk: MLD (Gy)|Doses in organs at risk: lung MLD (Mean Lung Dose)|during treatment planning||||Gy||Standard Deviation|Mean
2839994|NCT00181363|Primary|Dose Homogeneity 2: V105% and V107%|Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position|1 day after treatment planning|To investigate dose homogeneity V105% (volume of tissue receiving more than 105% of the prescribed dose) and V107% (volume of tissue receiving more than 107% of the prescribed dose) were calculated for prone position versus supine position.|||cc||Standard Deviation|Mean
2839995|NCT00181363|Primary|Dose Homogeneity 1: PTV|Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position|1 day after treatment planning|To investigate dose homogeneity and maximum doses, Dmin (minimum Dose), Dmax (maximum Dose) and Dmean (mean Dose) were calculated for prone position versus supine position.|||Gy||Standard Deviation|Mean
2839996|NCT00181285|Primary|Number of Participants Who Considered the Pneumatic Vest Convenient to Use|The study vest was convenient to use.|After four treatments of 15 minutes each|1 participant in the Sham group and 1 participant in the Active group had missing data for the question regarding the convenience of the pneumatic vest, therefore these participants were not included in the number analyzed for the outcome measure data table below.|||Participants|||Count of Participants
2839997|NCT00181285|Primary|Patient Adherence to High Frequency Chest Wall Oscillation|Patient adherence to therapy after four treatments.|After four treatments of 15 minutes each||||Percent of 60 minutes prescribed||Standard Deviation|Mean
2839998|NCT00181207|Secondary|Quality of Life|The SF-36 is used to measure health related quality of life. It assesses eight health concepts and provides physical and mental health summary scores. The summary scores range from 0 to 100, with 0 representing the worst and 100 the best quality of life.|Change from baseline to 12 weeks||||units on a scale||Inter-Quartile Range|Mean
2839999|NCT00181207|Primary|The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.|count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms.|12 weeks||||exacerbations per 12 weeks||Inter-Quartile Range|Mean
2840000|NCT00181168|Secondary|Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity||21 Days|||||||
2840001|NCT00181168|Primary|PET-CT Fusion Scanning Sensitivity|PET/CT was performed before (basal PET) and 24-48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.|21 Days||||percentage of participants||95% Confidence Interval|Number
2840002|NCT00181155|Secondary|Cardiac PCr/ATP Post Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.|||ratio||Standard Deviation|Mean
2840003|NCT00181155|Primary|Myocardial CK Flux Post Intravenous Allopurinol Infusion.|The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.|||umol/g/sec||Standard Deviation|Mean
2840004|NCT00181155|Secondary|Cardiac PCr/ATP Pre Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|Onset of image acquisition.|Data were analyzed for all participants who completed the MRS per protocol.|||ratio||Standard Deviation|Mean
2840005|NCT00181155|Primary|Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion|Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion|Onset of imaging acquisition.|Data were analyzed for all participants who completed the MRS per protocol.|||umol/g/sec||Standard Deviation|Mean
2840006|NCT00180713|Secondary|Change in Quality of Life Score|Change in quality of life score from baseline as measured by Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) scored from 1-25, with higher scores indicating worse quality of life, the investigator reported the score change.|6 months||||change of score||Standard Deviation|Mean
2840010|NCT00180713|Primary|Change in Right Ventricular Mass From Baseline|As measured by cardiac magnetic resonance (the study is powered to detect an 8.5g difference in RV mass between the two treatments, based on reproducibility measurements of RV mass in healthy volunteers and patients)|6 months post study treatment||||grams||Standard Deviation|Mean
2840011|NCT00180687|Secondary|Postoperative Morphine Use|The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events|24 Hoiurs||||mg||Full Range|Mean
2840012|NCT00180687|Secondary|Hours Needed for Safe Mobilization|Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.|24 Hours||||Hours needed for safe mobilization||Full Range|Mean
2840013|NCT00180687|Secondary|Number of Vomiting / Nausea Episodes|Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.|24 hours||||Number of vomitting / Nausea episodes||Full Range|Mean
2840014|NCT00180687|Primary|Reduction in Postoperative Pain|Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.|0 hours, 6 hours, 12 hours, 24 hours||||units on a scale||Full Range|Mean
2840015|NCT00180661|Secondary|Sputum Eosinophils||Once|No data collected||||||
2840016|NCT00180661|Secondary|Biopsy Eosinophils||Once|No data collected||||||
2840017|NCT00180661|Secondary|Exhaled NO||1 day|No data collected||||||
2840018|NCT00180661|Primary|Effect of Corticosteroids on Release of Cytokines From Macrophages||Once|No data collected||||||
2840019|NCT00180661|Primary|Suppression of Monocyte Activation and Alveolar Macrophage Activation by Dexamethasone Ex-vivo|IL8 - Interleukin-8 (IL-8) is a cytokine produced by many normal cells including monocytes, neutrophils, fibroblasts, and endothelial cells|1 day||||% of supression||Full Range|Mean
2840020|NCT00180661|Primary|Lung Function FEV1|FEV1, or forced expiratory volume, is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second.|1 day||||% of predicted||Standard Deviation|Mean
2840021|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840022|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840023|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840024|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840025|NCT00180479|Secondary|In-segment % Diameter Stenosis (% DS)|Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percent of in-segment diameter stenosis||Standard Deviation|Mean
2840026|NCT00180479|Secondary|In-stent % Diameter Stenosis (% DS)|In-stent: Within the margins of the stent, the value calculated as 100 * (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percent diameter stenosis||Standard Deviation|Mean
2840027|NCT00180479|Secondary|% Volume Obstruction (% VO)|Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percent of volume obstruction||Standard Deviation|Mean
2840028|NCT00180479|Secondary|In-stent Late Loss|In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||millimeters||Standard Deviation|Mean
2840029|NCT00180479|Secondary|Distal Late Loss|Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||millimeters||Standard Deviation|Mean
2840030|NCT00180479|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||millimeters||Standard Deviation|Mean
2840031|NCT00180479|Secondary|Acute Success: Clinical Procedure|Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital||||percentage of participants|||Number
2840032|NCT00180479|Secondary|Acute Success: Clinical Device|Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital||||percentage of participants|||Number
2840033|NCT00180479|Secondary|Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection|"Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.~Persisting dissection @ follow-up, present post-procedure."|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percentage of participants|||Number
2840034|NCT00180479|Secondary|In-segment % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percentage of participants|||Number
2840035|NCT00180479|Secondary|In-stent % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.|||percentage of participants|||Number
2840036|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840037|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840038|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event(MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840039|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840115|NCT00179478|Primary|Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years|Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.|10 years||||Percent cumulative probability||95% Confidence Interval|Number
2840040|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840041|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840042|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840043|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|4 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840044|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|3 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840045|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840046|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840047|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840048|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840049|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840116|NCT00179413|Secondary|Development of Portal Hypertension|Number of patients who develop endoscopic evidence of varices over 4 year period|4 years|The number of patients at risk include only those patients who at the baseline endoscopy had no evidence of portal hypertension or varices|||Participants|||Count of Participants
2840050|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840051|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840052|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840053|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|1 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840054|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840055|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840056|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840057|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840058|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840059|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|2 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840089|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12|The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-F data.|||units on a scale||Standard Deviation|Mean
2840060|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840061|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840062|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.|||percentage of participants|||Number
2840063|NCT00180479|Secondary|Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2840064|NCT00180479|Primary|Primary Endpoint: In-segment Late Loss (LL)|In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.|240 days|Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.|||millimeters||Standard Deviation|Mean
2840065|NCT00180323|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up|implant (baseline), 3 Months, 6 Months||||% of cardiac volume||Standard Deviation|Mean
2840066|NCT00180323|Secondary|6 Minute Walk Test|6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.|implant (baseline), 3 months and 6 months Follow-up||||meter||Standard Error|Mean
2840067|NCT00180323|Primary|Optimal AV-Delay (AVD)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.|Implant (baseline), 3 months and 6 months Follow-up||||ms||Standard Deviation|Mean
2840068|NCT00180323|Primary|Aortic Velocity Time Integral (VTI)|Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).|At implant (baseline), 3 months and 6 months Follow-up||||cm||Standard Deviation|Mean
2840069|NCT00180271|Secondary|Recurrent Heart Failure Events|"The MADIT-CRT secondary outcome evaluated the effects of CRT-D, relative to ICD, on the recurrence of heart failure events over the full study period An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:~administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or~administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay."|Time of event, DSMB review||||Participants|||Count of Participants
2840070|NCT00180271|Primary|Mortality From Any Cause or First Heart Failure (HF) Event|"MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:~administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or~administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay."|Outcome measured at average follow-up duration of 2.4 years.|"Analysis was performed on an intention-to-treat basis and counted the time to first event. The category Patients with Death at Any Time, includes deaths that occurred after the first heart failure event."|||Participants|||Number
2840071|NCT00179998|Secondary|Antibiotic Treatment Days|Total number of days treated with IV, oral or nebulized antibiotics over 6 initial month interval|per 6 month interval|Subjects included children < 30 months of age who were newly diagnosed with Cystic Fibrosis. Subjects were recruited from Nationwide Children's (AKA Columbus Children's) and Dayton Children's Hospitals.|||days||Standard Deviation|Mean
2840072|NCT00179998|Primary|Infant Pulmonary Function Tests (FEV0.5)|Change in FEV0.5 from initiation of intervention to 6 months|6 months|Children < 30 months of age with cystic fibrosis who were given either the study drug followed by the placebo or given placebo followed by study drug. Data is not available for the second period, as the PI has retired and is no longer associated with NCH.|||z score||Standard Deviation|Mean
2840088|NCT00179621|Secondary|Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period|"Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to week 52|Safety population.|||participants|||Number
2840073|NCT00179998|Primary|Chest CT (High Resolution Computed Tomography (HRCT) Score)|"Change in Total HRCT Score from initiation of intervention to 6 months~Modified Maffessanti HRCT Scoring System~Airways~Bronchial Wall Thickening:1 = mild, 2 = moderate, 3 = severe~Bronchiectasis:1 = mild, 2 = moderate, 3 = severe~Axial extent of 1 or 2: 1 = central/middle, 2 = also periphery~Regional extent of 1 or 2: x 1 if < 50 %, x 2 if > 50 %~Gas trapping score:0 if 1 sub-segment, 1 if < 25 %, 2 if 25 - 50 %, 3 if 50 - 75 %, 4 if > 75 % Multiply (# 1 + # 2 + # 3) by # 4 then add # 5~Parenchyma~Airspace disease: 0 = none, 1 = present~Ground glass opacity: 0 = none, 1 = present~Mucous Plugging: 0 = none, 1 = present~Total Score = Airway + Parenchymal Scores for RUL, LUL, RLL, and LLL Sections. The Total Score ranges from 12 to 92, with higher scores indicating greater impairment.~Maximum Score = 4 x 23 = 92"|6 months|Subjects will include children with CF < 30 months old and never treated with Pulmozyme. Patients available for recruitment will include 12 newly diagnosed children <30 months old from Nationwide Children's Hospital and 4 from Dayton Children's.|||Score points||Standard Deviation|Mean
2840074|NCT00179959|Primary|Change in Eczema Area and Severity Index (EASI)Scores According to Location|The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician's Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).|Baseline and 3 months|Analysis was per protocol.|||Change in EASI Score||Standard Deviation|Mean
2840075|NCT00179673|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.|Safety Population, which includes all participants who received at least one dose of study drug.|||participants|||Number
2840076|NCT00179673|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent to treat population|||months||95% Confidence Interval|Median
2840077|NCT00179673|Secondary|The Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Includes participants with a response to treatment|||months||95% Confidence Interval|Median
2840078|NCT00179673|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders|||percentage of participants||95% Confidence Interval|Number
2840079|NCT00179673|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2840101|NCT00179621|Secondary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days|Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.|||Participants|||Number
2840080|NCT00179660|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 15.2 months.|Safety Population, which includes all participants who received at least one dose of study drug.|||participants|||Number
2840081|NCT00179660|Secondary|Progression-free Survival|"Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.~Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population|||months||95% Confidence Interval|Median
2840082|NCT00179660|Secondary|Duration of Tumor Control|The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with tumor control (CR, CRu, PR or SD).|||months||95% Confidence Interval|Median
2840083|NCT00179660|Secondary|Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with a response = CR, CRu or PR.|||months||95% Confidence Interval|Median
2840084|NCT00179660|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2840085|NCT00179660|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2840086|NCT00179647|Primary|Overall Incidence of Adverse Events|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks|Subjects who received study drug|||Participants|||Number
2840087|NCT00179647|Primary|Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks|||||||
2840648|NCT00168844|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840090|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12|The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-An data.|||units on a scale||Standard Deviation|Mean
2840091|NCT00179621|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12|"The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL).~In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL."|Baseline, Week 12|Participants who had both Baseline and Week 12 FACT-An data.|||units on a scale||Standard Deviation|Mean
2840092|NCT00179621|Secondary|Participant Count of Deaths During Double-blind and Open-label by Randomized Group|Count of participant deaths throughout the entire study and reported by the original treatment assignment.|up to 3 years|Safety Population|||Participants|||Number
2840093|NCT00179621|Secondary|Kaplan Meier Estimates of Overall Survival by Randomized Group|Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study.|up to 3 years|Safety population: All randomized participants who received any Lenalidomide or placebo.|||Months||95% Confidence Interval|Median
2840094|NCT00179621|Secondary|Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study|Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe.|up to 3 years|Intent to treat population. Participants represented in the treatment groups to which they were randomized.|||Participants|||Number
2840095|NCT00179621|Secondary|Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review|The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented.|up to 52 weeks|Modified intent to treat population, which is defined as participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Participants had to have had more than 1 post-baseline assessment in order to be evaluable for cytogenetic response.|||Participants|||Number
2840096|NCT00179621|Secondary|Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period|The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) <5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with <5% blasts pretreatment with an on study blast increase of 50% which is now >5% showed bone marrow progression.|up to 52 weeks|Intent to treat population. Participants represented in the treatment groups to which they were randomized. Placebo response is limited to the double-blind phase. There were 10 responders in the placebo group who achieved their response under lenalidomide treatment after crossover to open-label.|||Participants|||Number
2840097|NCT00179621|Secondary|Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase <500/mm^3.|up to week 52|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline absolute neutrophil counts (ANC) < 1,000/mm^3.|||Participants|||Number
2840098|NCT00179621|Secondary|Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of <100,000/mm^3 as an absolute increase of ≥30,000/mm^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm^3 but less than 30,000/mm^3.|up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline platelet count of <100,000/mm^3 to be included in the analysis.|||Participants|||Number
2840099|NCT00179621|Secondary|Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days|For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized.|Baseline, up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. MITT participants who were transfusion independent for >= 182 study days are included.|||g/dL||Standard Deviation|Mean
2840100|NCT00179621|Secondary|Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days|Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included.|up to 3 years|The modified intent-to-treat (mITT) population included all participants who achieved RBC transfusion independence for at least 182 days.|||Weeks||Standard Deviation|Mean
2840102|NCT00179621|Primary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)|The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.|||Participants|||Number
2840103|NCT00179517|Secondary|Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).|Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better.|Assessed for 3 months||||Scores on a scale||Standard Deviation|Mean
2840104|NCT00179517|Secondary|Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).|The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T-A) and depotestosterone plus placebo (T-P) were reported.|Assessed for 3 months||||number of seizures||Standard Deviation|Mean
2840105|NCT00179517|Secondary|Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).|Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged for the three months. The ratio between the average estradiol levels and average luteinizing hormone levels were reported.|Assessed for 3 months||||Ratio||Standard Deviation|Mean
2840106|NCT00179517|Secondary|Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).|Bioavailable Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged for the three months. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported.|Assessed for 3 months||||Ratio||Standard Deviation|Mean
2840107|NCT00179517|Secondary|The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.|Bioavailable testosterone and estradiol levels were measured once a month over the three month study in subjects taking anastrozole and subjects taking placebo. The bioavailable testosterone and estradiol levels for the three months were averaged for each subject. The ratio between the average bioavailable testosterone level and average estradiol levels were reported.|Assessed for 3 months||||Ratio||Standard Deviation|Mean
2840108|NCT00179517|Secondary|Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).|Estradiol levels were measured once a month over the three month study in subjects taking anastrozole (T-A) and in subjects taking placebo (T-P). The average change in estradiol levels was reported.|Assessed for 3 months||||pg/mL||Standard Deviation|Mean
2840109|NCT00179517|Secondary|Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).|Bioavailable testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported.|Assessed for 3 months||||ng/dl||Standard Deviation|Mean
2840110|NCT00179517|Secondary|The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo|The proportion of men who achieve normalization of sexual scores (scores greater than or equal to 16/20) on anastrozole (T-A) and those on placebo (T-P) are reported. Both Men who achieve normalization of sexual scores and those who did not achieve normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group. Sexual scores were gathered once per month for three months with the average of the three months reported.|Assessed for 3 months||||Participants|||Count of Participants
2840111|NCT00179517|Primary|Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.|S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better.|3 month average||||Scores on a Scale||Standard Deviation|Mean
2840112|NCT00179478|Secondary|The Number of New or Enlarging MRI T2 Lesions at 10 Years|These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity|10 years|Analysis restricted to those participants with MRI scans able to evaluate at 10 years|||# of new or enlarging T2 lesions||Inter-Quartile Range|Median
2840113|NCT00179478|Secondary|Number of Participants With an EDSS > 3.5 at Study Completion|The EDSS is an ordinal scale of neurological impairment in Multiple Sclerosis with a range of 0 to 10 with 0.5 increments. A score of 0 is normal and 10 is death from MS. Scores from 1 to 3.5 are considered mild impairment , 4.0 to 6.5 is moderate and greater than 6.5 is severe impairment.|10 years|Numbers of patients completing 10 year evaluations|||Participants|||Count of Participants
2840114|NCT00179478|Secondary|Annualized Relapse Rate|annualized # of relapses between years 0 and 10|10 years|Analysis only in 10 year completers|||annualized relapses per year||Standard Deviation|Mean
2840118|NCT00179413|Primary|Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on:|number of patients with a liver related outcomes including: mortality, liver transplant, variceal or portal hypertensive bleeding,Development of jaundice, ascites or encephalopathy with an increase in CPT of > 2 points and development of hepatoma|4 years||||Participants|||Count of Participants
2840119|NCT00179309|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|80 months||||Participants|||Number
2840120|NCT00179309|Primary|Progression-free Survival (PFS)|Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.|19.7 months||||Months||95% Confidence Interval|Median
2840121|NCT00179127|Secondary|Total Hospital Stay|Unable to find any data on this study. PI left Vanderbilt and there was not a publication.|Days|||||||
2840122|NCT00179127|Secondary|Time on Insulin Drip|Unable to find any data on this study. PI left Vanderbilt and there was not a publication.|Minutes|||||||
2840123|NCT00179127|Primary|Time of Acidosis Correction|Unable to find any data on this study. PI left Vanderbilt and there was not a publication.|Minutes|||||||
2840124|NCT00179010|Other Pre-specified|Forearm Blood Flow||End of each stage (minute 15) of the study (baseline and each dose of adenosine or AMP ia infusions)|This was an exploratory Outcome and was abandoned.||||||
2840125|NCT00179010|Primary|Interstitial Adenosine Levels||Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)|13 subjects received both treatments. 3 subject did not complete the study and were excluded. We are reporting data in only 10 subjects that have collected samples.|||nM||Standard Error|Mean
2840126|NCT00178919|Primary|Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition|Systolic blood pressure at the highest tolerated dose of IV infusion of L-NMMA during autonomic nervous system blockade with trimethaphan. Trimethaphan, infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|End of 15 minutes of infusion of L-NMMA at the highest tolerated dose||||mm Hg||Standard Deviation|Mean
2840127|NCT00178919|Primary|Change in Systolic Blood Pressure|L-NMMA (nitric oxide synthase inhibitor) was infused intravenously at different doses for 15 minutes each, after blocking the autonomic nervous system with trimethaphan. The change in systolic blood pressure at the end of the highest tolerated dose is the main outcome. Trimethaphan infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|At the end of the highest tolerated dose of IV infusion of L-NMMA||||mm Hg||Standard Error|Mean
2840128|NCT00178841|Secondary|Pruritus Score|10-cm visual analog scale, 10= worst, 1=best|16 weeks||||units on a scale||Full Range|Mean
2840129|NCT00178841|Secondary|Quality of Life Evaluations|FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best|baseline and every 4 weeks||||units on a scale||Full Range|Mean
2840130|NCT00178841|Primary|Number of Participants With a 50% Improvement in Baseline Skin Score|mSWAT scoring. Range 0 to 400. Measured every 4 weeks.|16 weeks||||participants|||Number
2840131|NCT00178711|Other Pre-specified|Controlled Oral Word Association Test||0-12 months|||||||
2840132|NCT00178711|Other Pre-specified|Grooved Pegboard||0-12 months|||||||
2840133|NCT00178711|Other Pre-specified|Verbal Selective Reminding Test Trails B||0-12 months|||||||
2840134|NCT00178711|Other Pre-specified|Rey Osterrieth Complex Figure||0-12 months|||||||
2840135|NCT00178711|Other Pre-specified|Symbol Digit Modalities Test||0-12 months|||||||
2840136|NCT00178711|Other Pre-specified|Neurological Outcome Scale for Traumatic Brain Injury||0-12 months|||||||
2840137|NCT00178711|Other Pre-specified|Neurobehavioral Rating Scale - Revised||0-12 months|||||||
2840138|NCT00178711|Other Pre-specified|Disability Rating Scale||assessed 0-12 months|||||||
2840139|NCT00178711|Other Pre-specified|Glasgow Outcome Scale - Extended||0-12 months|||||||
2840140|NCT00178711|Primary|The Dichotomized Glasgow Outcome Scale|The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.|6 months with a window of plus or minus one month|Intention to Treat|||participants with a poor outcome|||Number
2840141|NCT00178685|Secondary|7 Day Point Prevelence (7DPP)|"Seven-day point prevalence abstinence (7DPP) was assessed by asking: Have you smoked a cigarette, even a puff, in the last 7 days?16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users."|12 months after the intervention|820 individuals were randomized to condition, of those, 12 died during the course of the study (all deaths were found to be unrelated to the study). Final analysis number included all those randomized and excluded those who died during the study.|||participants|||Number
2840142|NCT00178685|Primary|12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.|The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.|12 months after subject completes intervention.|A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.|||participants|||Number
2840649|NCT00168844|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840143|NCT00178633|Secondary|Change in Left Ventricular Mass|Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.|0-9 Months|broken out into 0-3months and 3-9months below|||g/m^2.7||95% Confidence Interval|Mean
2840144|NCT00178633|Secondary|Change in Tissue Doppler Diastolic Velocity|Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.|0-9 Months|Analysis broken down into 0-3 months and 3-9 months|||cm/s||95% Confidence Interval|Mean
2840145|NCT00178633|Secondary|Change in Glucose|Change in glucose. Negative values represent a decrease in glucose levels.|0-9 Months|broken out into 0-3months and 3-9months below|||mg/dL||95% Confidence Interval|Mean
2840146|NCT00178633|Primary|Change in Weight|Change in weight. Negative values represent weight loss.|0 to 9 months|broken out into 0-3months and 3-9months below|||kg||95% Confidence Interval|Mean
2840147|NCT00178503|Secondary|Mean Conners' Parent ADHD Index T Score by Week|The ADHD Index of the Conners' Parent Rating Scale-Revised (CPRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)||||Units on a scale (T-scores)||Standard Deviation|Mean
2840148|NCT00178503|Primary|Mean Continuous Performance Test (CPT)-Commission Errors by Dose|CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items.|Measured at each dosing week of the drug trial (placebo, low, medium, high)||||Total Errors||Standard Deviation|Mean
2840149|NCT00178503|Primary|Mean Conners' Teacher ADHD Index T Score by Dose|The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|Although there were 24 participants who completed the trial, teacher ratings were only available for 18 participants due to 6 children being seen during the summer months.|||Units on a scale (T-scores)||Standard Deviation|Mean
2840150|NCT00178477|Primary|Tumor Motion Related to Breathing as Determined From MRI Images|"Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location~Determine the reproducibility of target position over multiple breath-holds~Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds"|20 - 30 seconds|Data were not analyzed due to study termination.||||||
2840151|NCT00178464|Primary|Number of Adverse Events|Occurrence of individual adverse events and relationship to aspirin|12 months|Intention to treat|||events|||Number
2840152|NCT00178464|Secondary|# of Subjects Recruited Over Time, Screening Failures, Withdrawal Rates;Compliance (Pill Counts & Labs);Changes in Performance on Neurocognitive Tests; Changes in MRI/MRA; Changes in TCD;Incidences of Stroke, Acute Chest Crises, and Pain Crises||12 months|||||||
2840153|NCT00178464|Primary|Number of Serious Adverse Events|Occurrence of individual serious adverse events and relationship to aspirin|12 months|Intention to treat|||events|||Number
2840154|NCT00178399|Secondary|Analyze Impact of Disease Bulk and Number of Sites Involved.|Analysis or response and progression.|From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years|No data was collected for this outcome measure.||||||
2840155|NCT00178399|Secondary|Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles|Correlation of data from QOL questionnaires and blood markers.|30 months from date of registration.|No data was collected for this outcome measure.||||||
2840156|NCT00178399|Primary|Percentage of Palliatively Treated Patients With Progression-free Survival|Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.|24 months|Only palliative patients were included in this analysis|||percentage of participants|||Number
2840157|NCT00178399|Primary|Percentage of Curatively Treated Patients With Progression-free Survival|Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.|24 months|Only curative patients were included in this analysis|||percentage of participants|||Number
2840158|NCT00178256|Secondary|Median Survival|This is median survival for all subjects enrolled.|86 months||||months||Full Range|Median
2840159|NCT00178256|Primary|Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.||5 years||||Percentage subj w dose limiting toxicity|||Number
2840160|NCT00178191|Primary|Episodes/Day|number of incontinence episodes/day|9 months||||number||Standard Error|Mean
2840161|NCT00178178|Primary|Pain|Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.|3 day||||participants that experienced pain|||Number
2840162|NCT00178126|Primary|Sitting-induced Pressure Ulcers||6 months||||participants|||Number
2840163|NCT00177970|Secondary|6) Patients' Length of Hospital Stay|During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840164|NCT00177970|Secondary|5) Normalization of Body Temperature During a 24 Hour Period|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840165|NCT00177970|Secondary|4) Normalization of Neutrophil Count on CBC With Diff.|During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840166|NCT00177970|Secondary|3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea|A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840167|NCT00177970|Secondary|2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea|The quantity of anti-C. difficile antibodies with improve in relationship with recovery|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840168|NCT00177970|Secondary|1) 75% Reduction in Abdominal Pain/Tenderness|During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840169|NCT00177970|Primary|2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment|During the course of the study, we expect the IVIG group compared to the placebo group will have fewer number of stools per day (<3 per day).|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840170|NCT00177970|Primary|1) Normalization of WBC's|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM|during the course of the study|No results available record destroyed due to age of study. no publications||||||
2840171|NCT00177866|Secondary|Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment|No results or publication, data destroyed due to age of study.|completion of all study participants|||||||
2840172|NCT00177866|Primary|Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment|Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment|completion of all study participants|No results or publication, data destroyed due to age of study.||||||
2840173|NCT00177671|Post-Hoc|Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.|Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria.|2 year|This is the percent of participants with mild cognitive impairment (MCI) in each arm of the study.|||Percent of Participants|||Number
2840174|NCT00177671|Primary|Number of Participants With Recurrence of Major Depression|Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment.|2 years||||participants||95% Confidence Interval|Number
2840175|NCT00177671|Primary|Cognitive Instrumental Activities of Daily Living (IADL)|The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent).|baseline, year 1 and year 2|Some participants refused this testing.|||Percentage of participants|||Number
2840176|NCT00177671|Primary|Global Cognitive Performance|Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score.|Measured at baseline and Years 1 and 2 in maintenance||||Z-score||Standard Deviation|Mean
2840177|NCT00177307|Secondary|1-, 2-, and 3-year Overall Survival|Probability of being alive at 1-, 2-, and 3-years from start of protocol therapy|Up to 40 months||||percent chance|||Number
2840178|NCT00177307|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 40 months||||Months||95% Confidence Interval|Median
2840179|NCT00177307|Secondary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|Up to 27 months||||percentage of participants|||Number
2840180|NCT00177307|Primary|Progression Free Survival (PFS)|time from start of protocol therapy until objective tumor progression or death|Up to 27 Months||||Months||95% Confidence Interval|Median
2840181|NCT00177294|Primary|Remission|Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.|Measured at Week 6 or 22||||Percentage of participants||95% Confidence Interval|Number
2840182|NCT00177255|Secondary|Overall Response Rate|The number of responders (complete responders + partial responders) divided by the number of evaluable patients.|Every 2 cycles (6 weeks)||||percentage of participants||95% Confidence Interval|Number
2840183|NCT00177255|Primary|Overall Survival|The time interval between the date on which a patient first received protocol treatment and the documented date of death.|2 years||||Months||95% Confidence Interval|Median
2840202|NCT00176891|Secondary|Toxicity (Adverse Events) Associated With Infusions of Laronidase|Data was not collected on this outcome measure and is not available for reporting.|1 year post transplant|Data was not collected on this outcome measure and is not available for reporting.||||||
2840203|NCT00176891|Secondary|Reduction in Glycosaminoglycans (GAG)|Data was not collected on this outcome measure and is not available for reporting.|Prior to, During and After ERT|Data was not collected on this outcome measure and is not available for reporting.||||||
2840204|NCT00176891|Secondary|Patients With Grade III-IV Acute GVHD||Day 100 post transplant||||Participants|||Count of Participants
2840184|NCT00177216|Primary|Change in Diary Sleep Efficiency|The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment.|post treatment minus baseline. This averaged 69 days.|The number of subjects with sleep diaries at baseline and after at least 5 weeks of treatment. Not all of these participants 'completed' the protocol|||diff score of diary Sleep Efficiency||Standard Deviation|Mean
2840185|NCT00177216|Primary|Change in Pittsburgh Sleep Quality Index|Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.|post treatment minus baseline assessment battery. This averaged 100 days.|Number of subjects who had total PSQI scores after at least 5 weeks of treatment. The PSQI requires that all questions be answered for a total score to be calculated. This analysis includes participants who did not complete the protocol and also omits those who has missing total scores due to missing items on the PSQI|||difference score of PSQI total||Standard Deviation|Mean
2840186|NCT00177216|Secondary|Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint|Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep at all) to 100 (asleep the second the sleep recording starts (GNT) until the sleep recording ends (GMT) in the morning). The values below are post treatment SE minus pre treatment SE. A positive number means that the SE was higher (better) post treatment.|post treatment minus baseline PSG sleep studies. This averaged 70 days|Number of subjects who had polysomnography at Week 9 and at pretreatment. Some of the participants who 'completed' the protocol did not have follow up sleep studies.|||difference score for SE||Standard Deviation|Mean
2840187|NCT00177164|Secondary|Number of Participants With Treatment Emergent Hyperlipidemia|Number of participants with Hyperlipidemia as determined by safety labs|from baseline to end of 15 months|patients with bipolar disorder|||participants|||Number
2840188|NCT00177164|Secondary|Number of Participants With Treatment - Emergent Hyperglycemia|Number of participants with hyperglycemia based on safety labs|from baseline to end of 15 months|patients with bipolar disorder|||participants|||Number
2840189|NCT00177164|Secondary|BMI|BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups|baseline to end of 15 months|Patients with bipolar disorder|||kg / m^2||Standard Deviation|Mean
2840190|NCT00177164|Primary|Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.||Upto 15 months|2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.|||Number of clinical events||Standard Deviation|Mean
2840191|NCT00176917|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (aGVHD).|Toxicity (undesireable effect) of this stem cell transplant preparative regimen due to acute graft-versus-host disease.|Day 100 Post Transplant||||Participants|||Number
2840192|NCT00176917|Secondary|Number of Patients Who Failed Engraftment.|Toxicity (undesireable effect) of hematologic donor cell engraftment is determined by failure to engraft at Day 42.|Day 42 Post Transplant|1 patient of 41 failed engraftment - per protocol.|||Participants|||Number
2840193|NCT00176917|Secondary|Number of Patients Surviving on Study|Number of patients surviving (alive) at specified timepoints.|at 100 days, 1 year, and 3 years post transplant|Day 100 and 1 Year timepoints include all 41 patients. Year 3 includes 36 patients (5 pts not yet at followup timepoint.)|||Participants|||Number
2840194|NCT00176917|Primary|Mean Percentage of Donor Cells in Study Population (Chimerism).|Donor-derived engraftment determined by restriction fragment length polymorphism (RFLP).|at 21 days, 42 days, 60 days, 100 days, 6 months, and 1 year|Day 21 (24 patients included), Day 42 (15 pts), Day 60 (29 pts), Day 100 (25 pts), 6 Months (18 pts), 1 Year (16 pts).|||Percentage||Standard Deviation|Mean
2840195|NCT00176904|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease|Number of patients who exhibited chronic graft-versus-host disease by 1 Year post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Chronic GVHD is an extension of this syndrome.|1 Year Post Transplant||||Participants|||Number
2840196|NCT00176904|Secondary|Number of Patients With Grade III-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100||||Participants|||Number
2840197|NCT00176904|Secondary|Number of Patients With Grade II-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100||||Participants|||Number
2840198|NCT00176904|Secondary|Overall Donor Engraftment|Number of patients with full donor chimerism (state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease) by Day 100 post-transplant of at least 90%.|Day 100|1 Patient not included due to early death (before day 40).|||Participants|||Number
2840209|NCT00176878|Secondary|Number of Patients With Chronic Graft Versus Host Disease|Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands.|2 years||||Participants|||Number
2840210|NCT00176878|Secondary|Number of Patients With Grade 2-4 Acute Graft Versus Host Disease|Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening.|100 Days||||Participants|||Number
2840211|NCT00176878|Secondary|Number of Patients With Succcessful Engraftment After Transplantation|"Number of patients who received non-genotypic identical marrow or cord blood cells using a non-myeloablative preparative regimen and exhibited engraftment at Day 42."|42 Days||||Participants|||Number
2840212|NCT00176878|Secondary|Number of Patients Alive at Three Years (Survival)|Number of subjects who survived 3 years post-transplant.|3 years||||Participants|||Number
2840213|NCT00176878|Primary|Number of Patients Alive (Survival) at 2 Years|Calculated from day 1 of transplant to last contact.|2 years||||Participants|||Number
2840214|NCT00176865|Secondary|Compare Quality of Life (QOL)||Pretransplant, 1 year, 2 years and 5 years|PI made decision after IRB approval, but before opening the study to accrual, to not collect QOL data .||||||
2840215|NCT00176865|Secondary|Number of Subjects Alive at One Year||Day 365||||participants|||Number
2840216|NCT00176865|Secondary|Number of Subjects Alive at 100 Days||Day 100||||participants|||Number
2840217|NCT00176865|Secondary|Incidence of Chronic Graft Versus Host Disease (cGVHD)|Chronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs.|6 months and 1 year||||participants|||Number
2840218|NCT00176865|Secondary|Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)|Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.|Day 100||||participants|||Number
2840219|NCT00176865|Secondary|Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)|Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.|Day 100||||participants|||Number
2840220|NCT00176865|Secondary|Percentage of Donor Chimerism at 365 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 365|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||percentage of donor cells||Standard Deviation|Mean
2840221|NCT00176865|Secondary|Percentage of Donor Chimerism at 180 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 180|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||percentage of donor cells||Standard Deviation|Mean
2840222|NCT00176865|Secondary|Percentage of Donor Chimerism at 100 Days|The percent of recipient bone marrow and blood cells that are of donor origin.|Day 100|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||percentage of donor cells||Standard Deviation|Mean
2840223|NCT00176865|Primary|Number of Subjects With Mixed Chimerism|>10% Donor Cells at Day 100|Day 100|"Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.~Arm 3: 2 of 6 patients not evaluable due to early death."|||participants|||Number
2840224|NCT00176852|Secondary|Disease Free Survival|Number of patients alive without disease 1 year after transplant.|1 year||||Participants|||Count of Participants
2840225|NCT00176852|Secondary|Disease Free Survival|Number of patients alive without disease 100 days after transplant.|100 days||||Participants|||Count of Participants
2840226|NCT00176852|Secondary|Overall Survival|Number of patients alive 1 year after transplant.|1 year||||Participants|||Count of Participants
2840227|NCT00176852|Secondary|Overall Survival|Number of patients alive 100 days after transplant.|100 days||||Participants|||Count of Participants
2840228|NCT00176852|Secondary|Determine the Concentration of Campath in the Serum||Day 0|The Principal Investigator removed this as a study objective and therefore Campath concentrations were not collected.||||||
2840229|NCT00176852|Secondary|Determine Physical Characteristics and Biologic Effects of Mixed Populations of Donor and Host Red Blood Cells||During study|data were not collected||||||
2840230|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|2 years|Two of the 14 patients treated on Arm A2 died before 2 years and 2 failed their 2 year clinic appointment.|||units on a scale||Full Range|Median
2840231|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|1 year|Two of the 14 patients treated on Arm A2 died before 1 year.|||units on a scale||Full Range|Median
2840232|NCT00176852|Secondary|Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment|"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death."|pre-transplant||||units on a scale||Full Range|Median
2840260|NCT00176644|Secondary|To Measure Quality of Life of Patients Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
2840233|NCT00176852|Secondary|The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)|The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|1 year||||Participants|||Count of Participants
2840234|NCT00176852|Secondary|The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)|The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant.|6 months||||Participants|||Count of Participants
2840235|NCT00176852|Secondary|The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD)|The number of patients who experienced grades 3-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. IGrades 3-4 equate to moderate to severe disease. Symptoms typically appear within weeks after transplant.|100 days||||Participants|||Count of Participants
2840236|NCT00176852|Secondary|The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD)|The number of patients who experienced grades 2-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Grades 2-4 equate to mild to severe disease. Symptoms typically appear within weeks after transplant.|100 days||||Participants|||Count of Participants
2840237|NCT00176852|Secondary|The Incidence of Chimerism at 1 Year|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|1 year|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 1 year.|||Participants|||Count of Participants
2840238|NCT00176852|Secondary|The Incidence of Chimerism at 6 Months|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|6 months|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 6 months.|||Participants|||Count of Participants
2840239|NCT00176852|Secondary|The Incidence of Chimerism at 100 Days|The number of patients whose blood and/or bone marrow contains > 10% donor cells.|100 days|One of the 3 patients treated on Arm A was retreated at Day 40 and was not evaluable. One of the 14 patients on Arm A2 died before 100 days.|||Participants|||Count of Participants
2840240|NCT00176852|Primary|Number of Patients Who Experienced Grade 3-5 Treatment Related Toxicity|In general, grade 3 equates to moderate, grade 4 to severe and grade 5 to death.|1 year||||Participants|||Count of Participants
2840241|NCT00176839|Secondary|Incidence of Relapse|Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year||||participants|||Number
2840242|NCT00176839|Secondary|Incidence of Regimen-related Toxicity 100 Days Post Transplant|Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant||||participants|||Number
2840243|NCT00176839|Secondary|Incidence Chronic Graft-versus-host Disease (GVHD)|Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year||||participants|||Number
2840244|NCT00176839|Secondary|Incidence of Acute Graft-versus-host Disease (GVHD)|Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant||||participants|||Number
2840245|NCT00176839|Secondary|Probability of Engraftment|Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..|1 year||||participants|||Number
2840246|NCT00176839|Primary|Probability of Long-term Disease-free Survival (DFS)|Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year||||participants|||Number
2840247|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||3 years||||participants|||Number
2840248|NCT00176826|Secondary|Number of Patients With III-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant||||participants|||Number
2840249|NCT00176826|Secondary|Number of Patients With Graft Failure||Day 100 Post transplant||||participants|||Number
2840250|NCT00176826|Secondary|Number of Patients With Grade II-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant||||participants|||Number
2840251|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||1 year||||participants|||Number
2840252|NCT00176826|Secondary|Number of Patients With Treatment Related Mortality.||Day 100 Post Transplant||||participants|||Number
2840253|NCT00176826|Primary|Time to Transplant Engraftment||Day 100 Post Transplant||||days||Standard Deviation|Mean
2840254|NCT00176800|Secondary|Percentage of Patients That Require Dose Modification Due to Toxicity||8 years||||percentage of patients|||Number
2840255|NCT00176800|Secondary|Median Overall Survival Time|To measure the survival time in patients treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years||||months||95% Confidence Interval|Median
2840256|NCT00176800|Primary|Median Recurrence Free Survival Time|To measure the time recurrence in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years||||months||95% Confidence Interval|Median
2840257|NCT00176644|Secondary|To Assess the Plateau Level of Estradiol That is Attained With the Dose of 0.4mg/Day Given Via Transdermal Estradiol Patch and in Addition, Assess the Response on Testosterone in the Androgen Resistant Population.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
2840258|NCT00176644|Secondary|To Evaluate Time to Progression.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).||||||
2840261|NCT00176644|Primary|To Evaluate the Antitumor Activity, as Measured by PSA Response Rate in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years||||Response rate (percentage)|||Number
2840262|NCT00176631|Secondary|Proportion of Patients With a Decrease in BCL-2 Levels in PBMC and in the Degree of Plasma ER Receptor, Between Patients Who Responded to Treatment and Patients Who Did Not||7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
2840263|NCT00176631|Primary|Percentage of Patients With PSA Response|Decline from baseline value by > 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.|7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
2840264|NCT00176605|Secondary|Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.|All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.|5 years|No subjects experienced serious adverse events related to the intervention.|||participants|||Number
2840265|NCT00176605|Primary|PSA Response Rate|The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.|5 years||||percentage of participants|||Number
2840266|NCT00176501|Secondary|Rate of Graft-vs-host Disease||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.||||||
2840267|NCT00176501|Secondary|Rate and Kinetics of Clinical/Radiological Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.||||||
2840268|NCT00176501|Primary|Response Rate|With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.|5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.||||||
2840269|NCT00176488|Secondary|Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).||10 years|Study was closed prematurely and insufficient data was collected.||||||
2840270|NCT00176488|Secondary|Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.||10 years|Study was closed prematurely and insufficient data was collected.||||||
2840271|NCT00176488|Primary|Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.||10 years|Study was closed prematurely and insufficient data was collected.||||||
2840272|NCT00176462|Secondary|To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis||5 years|We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.||||||
2840273|NCT00176462|Primary|Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years|This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.|5 years|Number of high risk ALL patients treated.|||percentage of participants|||Number
2840274|NCT00176436|Secondary|Chemistry Panel||baseline, 10 weeks and 24 weeks|||||||
2840275|NCT00176436|Secondary|Vital Signs||Weekly for 24 weeks|||||||
2840276|NCT00176436|Secondary|Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.||24 weeks|||||||
2840277|NCT00176436|Primary|Change From Baseline in Weight|Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.|Weekly for 24 weeks||||kilograms||Standard Deviation|Mean
2840278|NCT00176306|Primary|Plasma Concentration of Levofloxacin|A peripheral intravenous catheter will be placed in each arm for drug administration and serial blood sampling. Pre-existing intravenous access will be utilized when possible. Subjects will rest in a supine position while receiving a 750 mg intravenous dose of levofloxacin over 90 minutes. Serial blood samples will be obtained 1.5, 3, 4, 5, 8, 12, and 24 hours after the beginning of administration of levofloxacin. Data will be presented as mean area under the curve +/- standard deviation.|24 hours|pilot study|||mg/L*hr||Standard Deviation|Mean
2840279|NCT00176254|Secondary|5 Year Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years||||participants|||Number
2840280|NCT00176254|Secondary|5 Year Disease-specific Survival|Outcome is calculated from the time of enrollment to the time of death due to disease under study or survival to 5 years without death from disease under study, whichever occurs first.The 5-year rates of disease-specific survival were calculated using the Kaplan-Meier method.|5 years||||participants|||Number
2840281|NCT00176254|Secondary|5 Year Overall Survival Rates||5 years post study||||participants|||Number
2840282|NCT00176254|Secondary|Frequency of Severe (>/= Grade 3) Toxicities||assessed starting on day 1 through study day 58 or until toxicity resolves|Intent to Treat|||adverse events|||Number
2840650|NCT00168844|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840283|NCT00176254|Primary|Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|assessed pre-study and once between days 36-57||||participants|||Number
2840284|NCT00176228|Secondary|Child Depression Rating Scale (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children's Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|weekly at baseline and each week during osing (8 weeks) and dose stabilized phase (6 weeks)||||units on a scale||Standard Deviation|Mean
2840285|NCT00176228|Primary|Young Mania Rating Scale (YMRS),|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|Weekly during the 8 week lamotrigine dose titration and 6 week full dose phase.||||units on a scale||Standard Deviation|Mean
2840286|NCT00176202|Secondary|Clinical Global Improvement in Bipolar Disorder Overall (CGI-BP Overall)|Severity of Illness and Global Improvement are rated on a 7-point scale by the clinician. In addition to rating the overall illness with the CGI-BP, severity and improvement are considered on various other dimensions such as mania, depression, attention deficit/hyperactivity, psychosis, aggression and sleep difficulties. Score of 1, 2 and 3 would mean there is clinically observed symptom improvement where 1 is the best outcome than 2 or 3. The point 4 is the point where the subject presents at baseline of that specific individual. If they become worse on clinical symptoms, they are rated as 5, 6 or 7 where 7 is worse than 5.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).||||units on a scale||Standard Deviation|Mean
2840287|NCT00176202|Secondary|Child Mania Rating Scale (CMRS)|Child Mania rating scale is a parent rated measure to screen for symptoms of mania. It includes 21 items reflecting the DSM-IV criteria for a manic episode. Each item is answered on a four-point Likert type scale anchored by 0 (Never/Rare), 1 (Sometimes), 2 (Often), and 3 (Very Often). Maximum score possible is 63. Score higher than 20 is considered clinically significant, and this is a dimensional score of manic severity.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).||||units on scale||Standard Deviation|Mean
2840288|NCT00176202|Secondary|Child Depression Rating Scale- Revised (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children's Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation are measured in this study to illustrate outcome at baseline and when the subject ended the study.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).||||units on a scale||Standard Deviation|Mean
2840289|NCT00176202|Primary|Young Mania Rating Scale (YMRS)|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. We show the mean and standard deviation at week 0 and 6.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|Inclusion criteria were a DSM-IV diagnosis of bipolar disorder Type I (mixed or manic episode); 8 to 18 years old; and medication free or currently clinically unstable on medication, justifying termination of the ineffective regimen.|||units on a scale||Standard Deviation|Mean
2840290|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.|||units on a scale||Standard Deviation|Mean
2840291|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.|||units on a scale||Standard Deviation|Mean
2840292|NCT00175877|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.|||percentage of participants|||Number
2840293|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.|||units on a scale||Standard Deviation|Mean
2840294|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects.|||hours||Standard Deviation|Mean
2840295|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects.|||units on a scale||Standard Deviation|Mean
2840296|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects.|||units on a scale||Standard Deviation|Mean
2840297|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.|||percentage of participants||95% Confidence Interval|Number
2840298|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240|The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.|||percentage of participants||95% Confidence Interval|Number
2840299|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192|The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.|||percentage of participants||95% Confidence Interval|Number
2840330|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.|The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.|||percentage of subjects|||Number
2840300|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144|The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.|||percentage of participants||95% Confidence Interval|Number
2840301|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96|The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.|||percentage of participants||95% Confidence Interval|Number
2840302|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48|The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.|||percentage of participants||95% Confidence Interval|Number
2840303|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.|||percentage of participants||95% Confidence Interval|Number
2840304|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240|The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.|||percentage of participants||95% Confidence Interval|Number
2840305|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192|The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.|||percentage of participants||95% Confidence Interval|Number
2840306|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144|The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.|||percentage of participants||95% Confidence Interval|Number
2840328|NCT00175825|Secondary|Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period|Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.|Baseline, during the 7-week Treatment Period||||percentage of change||Inter-Quartile Range|Median
2840307|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96|The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.|||percentage of participants||95% Confidence Interval|Number
2840308|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48|The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.|||percentage of participants||95% Confidence Interval|Number
2840309|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.|||percentage of participants||95% Confidence Interval|Number
2840310|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240|The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.|||percentage of participants||95% Confidence Interval|Number
2840311|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192|The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.|||percentage of participants||95% Confidence Interval|Number
2840312|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144|The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.|||percentage of participants||95% Confidence Interval|Number
2840313|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96|The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.|||percentage of participants||95% Confidence Interval|Number
2840329|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.|The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized.|After Month 12 to Final Visit|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.|||percentage of subjects|||Number
2840314|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48|The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.|||percentage of participants||95% Confidence Interval|Number
2840315|NCT00175877|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.|From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)|Safety Set|||percentage of participants|||Number
2840316|NCT00175877|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"A SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalisation or prolongation of existing hospitalisation~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above~First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set|||percentage of participants|||Number
2840317|NCT00175877|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set|||percentage of participants|||Number
2840318|NCT00175825|Primary|Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period|Calculated as 7-day partial onset seizure frequency.|During the 7-week Treatment Period||||Seizures per week||Inter-Quartile Range|Median
2840319|NCT00175825|Secondary|Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period|Number of days to first, fifth, and tenth seizure after baseline.|During the 7-week Treatment Period||||days||95% Confidence Interval|Median
2840320|NCT00175825|Secondary|Number of Seizure-free Days Per 4 Weeks|A day was considered seizure-free, if no seizure was reported during 24 hours.|Baseline, during the 7-week Treatment Period||||Days/4 Weeks||Inter-Quartile Range|Median
2840321|NCT00175825|Secondary|Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period|A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.|During the 7-week Treatment Period||||percentage of participants|||Number
2840322|NCT00175825|Secondary|Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period|Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.|During the 7-week Treatment Period||||percentage of participants|||Number
2840323|NCT00175825|Secondary|Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period|A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.|During the 7-week Treatment Period||||percentage of participants|||Number
2840324|NCT00175825|Secondary|Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period|Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.|During the 7-week Treatment Period||||percentage of change||Inter-Quartile Range|Median
2840325|NCT00175825|Secondary|Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period|Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.|During the 7-week Treatment Period||||seizures per week||Inter-Quartile Range|Median
2840326|NCT00175825|Secondary|Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period|Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.|During the 7-week Treatment Period||||seizures per week||Inter-Quartile Range|Median
2840327|NCT00175825|Secondary|Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period|Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.|During the 7-week Treatment Period||||seizures per week||Inter-Quartile Range|Median
2840651|NCT00168844|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840331|NCT00175019|Secondary|Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.|The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline who also had their tophi counted while receiving their final stable treatment were included in the analysis.|||percent change from baseline||Standard Deviation|Mean
2840332|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
2840333|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized.|Month 36|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
2840334|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized.|Month 24|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
2840335|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.|The percentage of subjects whose serum urate was <6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.|||percentage of subjects|||Number
2840336|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
2840337|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
2840338|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
2840339|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.|Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 1 visit was summarized.|Month 1|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis.|||percentage of subjects|||Number
2840340|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis.|||percent change from baseline||Inter-Quartile Range|Median
2840341|NCT00175019|Secondary|Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.|The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.|||percent change from baseline||Standard Deviation|Mean
2840652|NCT00168844|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840342|NCT00175006|Primary|Average Percent Difference in Area Between Raters|Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.|Visit 1 (Day 1 ) and Visit 2 (Day 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled.|||mm²||Standard Deviation|Mean
2840343|NCT00175006|Primary|Average Percent Difference in Area Between Visits|The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected.|||mm²||Standard Deviation|Mean
2840344|NCT00174967|Secondary|Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.|24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. Missing data was not imputed|||percent change from baseline||Standard Deviation|Mean
2840345|NCT00174967|Secondary|Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.|Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.|Baseline and Any visit (Day 7, 14, 21,or 28)|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL.|||percent change from baseline||Standard Deviation|Mean
2840346|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
2840347|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit|Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.|Baseline and Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
2840348|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.|Baseline and Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
2840349|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.|Baseline and Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percent change from baseline||Standard Deviation|Mean
2840350|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.|Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.|Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percentage of subjects|||Number
2840351|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.|Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percentage of subjects|||Number
2840352|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.|Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.|||percentage of subjects|||Number
2840353|NCT00174967|Primary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized.|Day 28.|Analysis performed on intent-to-treat (ITT) subjects, defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no postbaseline visits were available.|||percentage of subjects|||Number
2840354|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volume Between Readers|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit.|||cm³||Standard Deviation|Mean
2840355|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volument Between Visits|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected.|||centimeters³ (cm³)||Standard Deviation|Mean
2840356|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Final Visit.|The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840357|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.|The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.|Baseline and Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840358|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.|Baseline and Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840359|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.|Baseline and Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840360|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.|Baseline and Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840361|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.|Baseline and Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840362|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.|Baseline and Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects||Standard Deviation|Mean
2840363|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840364|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.|Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.|Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840365|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.|Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840390|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.|||centimeters||Standard Error|Least Squares Mean
2840366|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840367|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840368|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.|Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840369|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840370|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percent change from baseline||Standard Deviation|Mean
2840371|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.|||percentage of subjects|||Number
2840372|NCT00174915|Secondary|Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.|Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 28|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 28.|||percentage of subjects|||Number
2840373|NCT00174915|Secondary|Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit|Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
2840374|NCT00174915|Secondary|Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
2840375|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
2840376|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
2840413|NCT00174447|Secondary|Number of Participants With Scores on Patient Preference Scale (PPS)|Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.|Baseline, up to 5 years (End of Study)|ITT|||participants|||Number
2840377|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percent change||Standard Deviation|Mean
2840378|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percent change||Standard Deviation|Mean
2840379|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject.|Final Visit (up to 28 weeks).|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
2840380|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on intend to treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
2840381|NCT00174915|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).|Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 visits (any last 3 visits up to week 28)|Analysis was performed on all randomized subjects who took at least 1 dose of study drug and had a baseline serum urate ≥8.0 mg/dL. If subject prematurely discontinued from study before at least 3 serum urate levels were obtained, subject was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used.|||Percentage of subjects|||Number
2840382|NCT00174785|Other Pre-specified|Adjudicated Cardiovascular Death|The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
2840383|NCT00174785|Secondary|Cardiovascular Death|The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
2840384|NCT00174785|Secondary|First Hospitalization for Cardiovascular Reason|The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
2840385|NCT00174785|Secondary|Death From Any Cause|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population|||participants|||Number
2840386|NCT00174785|Primary|First Hospitalization for Cardiovascular Reason or Death From Any Cause|The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|"All efficacy analyses were performed on the all randomized patients population including all patients randomized irrespective of whether the patient actually received any drug or complied with the study protocol."|||participants|||Number
2840387|NCT00174460|Secondary|Growth Curve Comparison Based on Height: Control Arm|Growth curve comparison with height in centimeters as the dependent variable.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.|||centimeters||Standard Error|Least Squares Mean
2840388|NCT00174460|Secondary|Growth Curve Comparison Based on Height|Growth curve comparison with height in centimeters as the dependent variable.|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.|||centimeters||Standard Error|Least Squares Mean
2840389|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS: Control Arm|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.|||centimeters||Standard Error|Least Squares Mean
2840653|NCT00168844|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840391|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Control Arm|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 36|FAS; Control group received Somatropin from Month 12 onwards.|||participants|||Number
2840392|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Somatropin|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 24|FAS|||participants|||Number
2840393|NCT00174460|Secondary|Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years|Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants ≥6 years of age with evaluable data at observation for Somatropin and Control Arm, respectively. SDS reference values used were for the right hand but the hand grip strength measured for this study was for the dominant hand (may not have been the right hand).|||z-score||Standard Error|Least Squares Mean
2840394|NCT00174460|Secondary|Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)|Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
2840395|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)|Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Marrow Area was not analyzed as planned.||||||
2840396|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)|Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Cortical thickness was not analyzed as planned.||||||
2840397|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)|Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
2840398|NCT00174460|Secondary|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)|Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
2840414|NCT00174447|Primary|Change From Baseline in CGI-I at End of Study (up to 5 Years)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.|||score on a scale||Standard Deviation|Mean
2840654|NCT00168844|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/Litre (L)||Standard Deviation|Mean
2840399|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)|Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
2840400|NCT00174460|Primary|Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year|Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters per year||Standard Error|Least Squares Mean
2840401|NCT00174460|Secondary|Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years|Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.|||z-score||Standard Error|Least Squares Mean
2840402|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac|Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.|||millimeters||Standard Error|Least Squares Mean
2840403|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular|Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.|||millimeters||Standard Error|Least Squares Mean
2840404|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps|Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.|||millimeters||Standard Error|Least Squares Mean
2840405|NCT00174460|Secondary|Change From Baseline in Height SDS After 2 Years|Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters||Standard Error|Least Squares Mean
2840406|NCT00174460|Secondary|Change From Baseline in Height After 1 Year and After 2 Years||Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters||Standard Error|Least Squares Mean
2840407|NCT00174460|Secondary|Change From Baseline in Growth Velocity SDS After 2 Years|Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters per year||Standard Error|Least Squares Mean
2840408|NCT00174460|Secondary|Change From Baseline in Growth Velocity After 1 Year and After 2 Years|Growth velocity measured as centimeters per year.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.|||centimeters per year||Standard Error|Least Squares Mean
2840409|NCT00174460|Primary|Change in Height Standard Deviation Score (SDS) After 1 Year|Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|Full Analysis Set (FAS; all randomized subjects who had at least 1 post-baseline efficacy measurement); Control group received Somatropin from Month 12 onwards.|||centimeters||Standard Error|Least Squares Mean
2840410|NCT00174447|Primary|Change From Baseline in CGI-S at End of Study (up to 5 Years)|CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.|||score on a scale||Standard Deviation|Mean
2840411|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|ITT. LOCF.|||participants|||Number
2840412|NCT00174447|Secondary|Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)|DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study)|ITT. n= number of participants with analyzable data.|||score on a scale||Standard Deviation|Mean
2840655|NCT00168844|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^12/Litre (L)||Standard Deviation|Mean
2840415|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).|||participants|||Number
2840416|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I) Dichotomized Response|Scale measures subject's (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more|Baseline, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy. LOCF = Last Observation Carried Forward. Week 24 n=116; Week 24 LOCF n=136|||Particpants|||Number
2840417|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I)|Scale measures subject's clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Week (wk) 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with value (Week 24 n=116; Week 24 LOCF n=136)|||Participants|||Number
2840418|NCT00174382|Secondary|Clinical Global Impressions Severity (CGI-S)|Scale measures subject's clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).|Baseline|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with a value|||Participants|||Number
2840419|NCT00174382|Secondary|Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)|Scale measures subject's clinical condition at baseline for severity (CGI-S) & for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Baseline, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. Subjects with Baseline = 136; week 24 n = 116; week 24 LOCF n = 136|||Score on a scale||Standard Deviation|Mean
2840420|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)|The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114|||Score on a scale||Standard Deviation|Mean
2840421|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)|NPI-Q measures severity of behavioural manifestations of dementia & the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores & ranges from 0 to 36|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=137; weeks 12, 24 n = 124, 114|||Score on scale||Standard Deviation|Mean
2840422|NCT00174382|Secondary|Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)|The number of words a particpant can generate in 1 minute.|Baseline, 12 weeks, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=136; weeks 12, 24 n = 123, 113|||score on scale||Standard Deviation|Mean
2840423|NCT00174382|Secondary|CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)|CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF N=131; weeks 12, 24 n = 117, 106|||Score on a scale||Standard Deviation|Mean
2840424|NCT00174382|Secondary|Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)|The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF N=131; weeks 12, 24 n = 117, 106|||Score on scale||Standard Deviation|Mean
2840425|NCT00174382|Secondary|Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)|The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; weeks 12, 24 n = 123, 111|||Score on a scale||Standard Deviation|Mean
2840426|NCT00174382|Secondary|Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)|DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n = 124, 114|||score on a scale||Standard Deviation|Mean
2840427|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.|IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance & correspondence, medications, leisure & housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124,114|||score on a scale||Standard Deviation|Mean
2840428|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.|The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose of donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124, 114.|||score on a scale||Standard Deviation|Mean
2840429|NCT00174382|Primary|Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set|Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; Weeks 12, 24 n=124, 114|||Score on a scale||Standard Deviation|Mean
2840430|NCT00174291|Secondary|Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mg||Full Range|Median
2840431|NCT00174291|Secondary|Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||SDS||Full Range|Median
2840432|NCT00174291|Secondary|Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||grams||Full Range|Median
2840433|NCT00174291|Secondary|Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.||||||
2840434|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.||||||
2840435|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||milligram per deciliter (mg/dL)||Full Range|Median
2840436|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
2840437|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
2840438|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
2840439|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
2840440|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|Data was not analyzed because of change in planned analysis after early termination of the study.||||||
2840441|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Full Range|Median
2840442|NCT00174265|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.|Baseline of A7501013 to Day 365|ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model.|||Units on a Scale||Standard Error|Least Squares Mean
2840443|NCT00174265|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.|Baseline of A7501013 to Day 365|Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.|||Units on a Scale||Standard Error|Least Squares Mean
2840444|NCT00174252|Secondary|IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.|||ratio||Standard Deviation|Mean
2840445|NCT00174252|Secondary|IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.|||ratio||Standard Deviation|Mean
2840446|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 - reference mean) / reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.|||SD||Standard Deviation|Mean
2840447|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.|||SD||Standard Deviation|Mean
2840448|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable BA/CA data at 12 and 24 months.|||ratio||Standard Deviation|Mean
2840656|NCT00168844|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
2840449|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable BA/CA data at 12 and 24 months.|||ratio||Standard Deviation|Mean
2840450|NCT00174252|Other Pre-specified|Change in BA From Baseline at 12 and 24 Months|Change in BA was calculated as: (12 or 24 months minus Screening)|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BA data at 12 and 24 months.|||year||Standard Deviation|Mean
2840451|NCT00174252|Secondary|ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (BA) at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 24 months.|||SD for BA||Standard Error|Mean
2840452|NCT00174252|Secondary|ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (BA) was calculated as:~Height SD (BA) at 12 months minus Height SD (BA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 12 months.|||SD for BA||Standard Error|Mean
2840453|NCT00174252|Secondary|ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (CA) at 24 months.|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 24 months.|||SD for CA||Standard Error|Mean
2840454|NCT00174252|Secondary|Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (CA) was calculated as:~Height SD (CA) at 12 months minus Height SD (CA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 12 months.|||SD for CA||Standard Error|Mean
2840455|NCT00174252|Other Pre-specified|Summary of Body Mass Index (BMI) at 12 and 24 Months|BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BMI data at 12 and 24 months.|||kg/meters squared (m2)||Standard Deviation|Mean
2840456|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 12 months. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 24 months.|||SD for BA||Standard Deviation|Mean
2840457|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 24 months.|||SD for BA||Standard Deviation|Mean
2840458|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 12 months.|||SD for CA||Standard Deviation|Mean
2840459|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD CA data at 12 and 24 months.|||SD for CA||Standard Deviation|Mean
2840460|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 12 months. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 24 months.|||SD for CA||Standard Deviation|Mean
2840461|NCT00174252|Other Pre-specified|Growth Rate at 12 and 24 Months|"Growth Rate was calculated at 12 months as:~(Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25}~Growth Rate was calculated at 24 months as:~(Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable growth rate data at 12 and 24 months.|||cm/year||Standard Deviation|Mean
2840462|NCT00174252|Secondary|Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 12 or 24 months minus height in SD at Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 or 12 months with evaluable height SD BA data at 12 and 12 months.|||SD for BA||Standard Deviation|Mean
2840463|NCT00174252|Secondary|Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 24 months minus height in SD at Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 24 months.|||Height in SD||Standard Deviation|Mean
2840464|NCT00174252|Secondary|Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 12 months minus height in SD at Baseline."|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 12 months.|||SD for BA||Standard Deviation|Mean
2840465|NCT00174252|Secondary|Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 12 or 24 months minus height in SD at Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable Height SD CA data at 12 and 24 months.|||SD for BA||Standard Deviation|Mean
2840466|NCT00174252|Secondary|Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 24 months minus height in SD at Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 24 months.|||SD for CA||Standard Deviation|Mean
2840467|NCT00174252|Secondary|Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at 12 months minus height in SD at Baseline."|Baseline, 12 months|The full analysis set (FAS) included all patients who received at least one dose of assigned treatment and had at least one subsequent rating of IGF-1. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 12 months.|||SD for CA||Standard Deviation|Mean
2840468|NCT00174252|Primary|Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months|Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.|9 and 12 months|The safety analysis set (SAS) was defined as all patients who received at least one dose of GH treatment. Number of Participants Analyzed = Number of children treated.|||percentage of participants|||Number
2840469|NCT00174252|Other Pre-specified|Change in Height From Baseline|The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with evaluable height data at 12 and 24 months.|||centimeters (cm)||Standard Deviation|Mean
2840470|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3||Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)|FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.|||milligram per deciliter (mg/dL)||Full Range|Median
2840471|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3||Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||nanogram per milliliter (ng/mL)||Full Range|Median
2840472|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])|GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840473|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])|GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840474|NCT00174187|Other Pre-specified|Growth Velocity (GV)|Growth velocity measures the annual rate of increase in height.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||cm/year||Inter-Quartile Range|Median
2840700|NCT00168831|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||millimoles per litre (mmol/L)||Standard Deviation|Mean
2840475|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840476|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840477|NCT00174187|Secondary|Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Inter-Quartile Range|Median
2840478|NCT00174187|Secondary|Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percent change||Inter-Quartile Range|Median
2840479|NCT00174187|Secondary|Bone Mineral Content of Total Body (BMC [TB])|DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||gram||Inter-Quartile Range|Median
2840480|NCT00174187|Secondary|Bone Mineral Density of Lumbar Spine (BMD [LS])|BMD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||g/cm^2||Inter-Quartile Range|Median
2840481|NCT00174187|Secondary|Bone Mineral Density of Total Body (BMD [TB])|BMD (TB) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||gram per square centimeter (g/cm^2)||Inter-Quartile Range|Median
2840482|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840483|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840484|NCT00174187|Secondary|Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])|BMAD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||gram per cubic centimeter (g/cm^3)||Inter-Quartile Range|Median
2840485|NCT00174187|Secondary|Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840486|NCT00174187|Secondary|Fat Mass as Percentage of Total Weight|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percentage of total weight||Inter-Quartile Range|Median
2840487|NCT00174187|Secondary|Percent Change From Baseline in Fat Mass at Year 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Inter-Quartile Range|Median
2840488|NCT00174187|Secondary|Annual Percent Change in Fat Mass at Year 1, 2 and 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percent change||Inter-Quartile Range|Median
2840489|NCT00174187|Secondary|Fat Mass|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||kg||Inter-Quartile Range|Median
2840490|NCT00174187|Secondary|Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||SDS||Inter-Quartile Range|Median
2840491|NCT00174187|Secondary|Lean Body Mass as Percentage of Total Weight|Lean body mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percentage of total weight||Inter-Quartile Range|Median
2840492|NCT00174187|Secondary|Percent Change From Baseline in Lean Body Mass at Year 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Inter-Quartile Range|Median
2840493|NCT00174187|Secondary|Annual Percent Change in Lean Body Mass at Year 1, 2 and 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||percent change||Inter-Quartile Range|Median
2840494|NCT00174187|Secondary|Lean Body Mass|Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.|||kilogram (kg)||Inter-Quartile Range|Median
2840495|NCT00174187|Secondary|Bone Age|Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|||years||Inter-Quartile Range|Median
2840592|NCT00169442|Secondary|Anti-D and Anti-T Antibody Concentrations.|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2840496|NCT00174187|Primary|Puberty Stage at Final Height|Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.|When final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.|||participants|||Number
2840497|NCT00174187|Primary|Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.|||SDS||Full Range|Median
2840498|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.|||SDS||Full Range|Median
2840499|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.|||Standard Deviation Score (SDS)||Inter-Quartile Range|Median
2840500|NCT00172185|Secondary|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)|6 months|Response Status is Yes or No|||participants|||Number
2840501|NCT00172185|Primary|Number of Subjects Achieving a 20% Reduction at Week 28|"For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use.~For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use."|28 weeks|Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures.|||Participants|||Number
2840502|NCT00172042|Primary|Percentage of Participants With Progression-Free Survival Events|Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants|||Number
2840503|NCT00172042|Primary|Kaplan-Meier Estimates for Progression-free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2840504|NCT00172042|Secondary|Kaplan-Meier Estimates for Overall Survival||Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2840505|NCT00172042|Secondary|Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)|Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event|Months 6,12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.|||Percentage of participants||95% Confidence Interval|Number
2840506|NCT00172042|Secondary|Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry|Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.|Months 12 and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants|||Number
2840568|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840507|NCT00172042|Secondary|Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases|Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.|||Percentage of participants||95% Confidence Interval|Number
2840508|NCT00172042|Secondary|Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months|Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18 and 24|Intent-to-Treat Population consisting of all randomized participants.|||Percentage of participants|||Number
2840509|NCT00172042|Primary|Progression-Free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.|||Months||95% Confidence Interval|Median
2840510|NCT00171925|Secondary|The Number of Participants With the Development of Skeletal Complications|"Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline~Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography~Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression~Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression~Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl"|48 months|Intent to treat population|||Participants|||Number
2840511|NCT00171925|Secondary|Number of Patients With Progression by Individual Criteria|Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon & Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.|48 months|Intent to Treat Population|||Participants|||Number
2840512|NCT00171925|Primary|Days of Progression Free Survival|"Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events:~progression to stage II or III according to Salmon & Durie classification~skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia)~unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically."|48 months|Intent to Treat Population|||Days||Standard Error|Mean
2840513|NCT00171873|Secondary|Survival||at least on a monthly basis|||||||
2840514|NCT00171873|Secondary|Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study||at three-month intervals|||||||
2840515|NCT00171873|Secondary|Symptom Control at 3 Month Intervals||at 3 month intervals up to 18 moths|||||||
2840516|NCT00171873|Secondary|Biochemical Response at 3 Month Intervals||at 3 month intervals up to 18 moths|||||||
2840517|NCT00171873|Secondary|Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals||at 3 month intervals|||||||
2840518|NCT00171873|Primary|Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)|Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.|Up to 7 years|Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.|||Months||95% Confidence Interval|Median
2840519|NCT00171834|Secondary|Duration of Overall Response -Phase I and Phase II|Duration of overall response (CR or PR) measured by RECIST was measured from the first documented CR or PR to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
2840520|NCT00171834|Secondary|Time to Overall Response -Phase I and Phase II|Time to overall response (CR or PR) measured by RECIST was the time between study start until date of first documented response (CR or PR).|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
2840593|NCT00169442|Secondary|Anti- PRP Antibody Concentrations.|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2840521|NCT00171834|Secondary|Duration of Stable Disease-Phase I and Phase II|Duration of stable disease (CR, PR, or SD) by RECIST was defined as the time from start of study drug to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
2840522|NCT00171834|Primary|Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator's assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks.|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Participants|||Number
2840523|NCT00171834|Primary|Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m^2 until MTD in steps of 0.5 mg/m^2 until 12 mg/m^2, then in steps of 1 mg/m^2 till 13.0 mg/m^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m^2, thus, the MTD as defined by the protocol was not reached in this study.|Cycle 1 (21 days)|Maximum tolerated dose (MTD) determining population.included all patients who completed the first treatment cycle (Cycle 1) according to protocol or discontinued due to a DLT. The first cycle data from this patient population were used to determine the MTD in the Phase I part of the study.|||Dose Limiting Toxicity (DLT)|||Number
2840524|NCT00171834|Secondary|Time to Progression (TTP)-Phase I and Phase II|Time to progression was measured from the start of study drug to the date of first documented disease progression by RECIST, discontinuation due to disease progression, or death from underlying cancer, whichever event occurred first. If a patient had not progressed by RECIST, discontinued due to disease progression, or died from underlying cancer, TTP was censored at the time of last adequate tumor assessment. However, if a patient took any new cancer therapy prior to PD or death, then TTP was censored at the date of last adequate tumor assessment prior to the start date of new cancer therapy.|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
2840525|NCT00171834|Secondary|Overall Survival Time-Phase I and Phase II|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Data was collected post treatment every 3 months until approximately 70% of patients have reached the survival endpoint (Phase I + Phase II).|From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Months||95% Confidence Interval|Median
2840526|NCT00171834|Secondary|Number of Participants With Best Overall Response-Phase I|This was defined as the number of participants whose best overall response was CR or PR by RECIST. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.|||Participants|||Number
2840527|NCT00171704|Secondary|Time to Overall Survival Events|Overall survival was measured from date of randomization to date of death.|60 Months|All randomized patients constituted the ITT Population, unless withdrawal of consent occurred after randomization but before the start of study treatment assigned.|||days||Inter-Quartile Range|Median
2840528|NCT00171704|Secondary|Time to Disease Recurrence or Death|Disease-free survival was defined as the interval between randomization and earliest confirmed event of loco-regional recurrence, distant metastases, invasive contralateral breast cancer, or death from any cause.|60 months|Analysis of disease-free survival was based on the ITT principle, with all enrolled (and randomized) patients included. The Kaplan-Meier product-limit approach was used.|||Days||Inter-Quartile Range|Median
2840701|NCT00168831|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840529|NCT00171704|Secondary|Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. Numbers are not additive, as patients could be included in multiple rows.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients with pre-defined clinically relevant changes in serum lipids over the course of 5 years in each treatment arm is presented.|||Participants|||Number
2840530|NCT00171704|Secondary|Percentage Change From Baseline in Serum Lipids at 5 Years|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of serum lipids was on the treatment group median percent change from baseline (and range) at 5 years.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis.|||Percent Change||Full Range|Median
2840531|NCT00171704|Secondary|Median Percent Change From Baseline of Serum Markers of Bone Turnover|Bone turnover markers (fasting serum procollagen-I extension peptide [P1NP], C-telopeptide [CTX], skeletal bone-specific alkaline phosphatase [BSAP, N-telopeptide [NTX]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of bone markers was based on analysis of variance of the regression slopes calculated for each individual patient and each bone marker over time. In the following summary, only the median treatment group percent change from baseline (and range) at 5 years is presented for each bone marker.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis. The analysis of bone markers over time consisted of patients with measurements of specific markers at each time point.|||Percent Change||Full Range|Median
2840532|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip|Total hip BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis of BMD at 5 years included all patients enrolled with centrally assessed measurements of total hip BMD.|||Percent Change||Full Range|Median
2840533|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine|Lumbar spine (L2-L4)BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis at 5 years included all patients enrolled and who had centrally assessed measurements of lumbar spine and/or total hip BMD.|||Percent change||Full Range|Median
2840534|NCT00171704|Primary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)|Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 24 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients in each treatment arm who had completed 2 years of the study and had centrally assessed measurements of lumbar spine or total hip BMD.|||Percent Change||Full Range|Median
2840535|NCT00171340|Secondary|Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline|At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.|Baseline,3 years|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.|||Percentage of Participants|||Number
2840536|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.|||Percentage change in BMD||Standard Deviation|Mean
2840537|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.|||Percentage change in BMD||Standard Deviation|Mean
2840538|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.|||Percentage change in BMD||Standard Deviation|Mean
2840539|NCT00171340|Primary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).|Baseline, 12 months|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.|||Percentage change in BMD||Standard Deviation|Mean
2840702|NCT00168831|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840540|NCT00171314|Secondary|Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3|Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.|Year 3|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at Year 3 were included in this analysis.|||Percentage of Participants|||Number
2840541|NCT00171314|Secondary|Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. During different time points, participants with observations at that time point were included in the analysis.|||Percent Change||Standard Deviation|Mean
2840542|NCT00171314|Secondary|Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization.|||Percent Change||Standard Deviation|Mean
2840543|NCT00171314|Secondary|Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 2, Year 3, Year 4, Year 5|"Analysis of safety:safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. n in each category indicates participants with data at baseline and each corresponding timepoint."|||Percent Change||Standard Deviation|Mean
2840544|NCT00171314|Primary|Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline - 12 months|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at baseline and 12 months were included in this analysis.|||Percent Change||Standard Deviation|Mean
2840545|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level for All Participants Measured From Core Study Baseline (BL) to End of Extension Study, by Baseline Liver Iron Content (LIC)|Serum Levels were assessed at core study baseline (BL) and then 1 year and 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study). Serum Ferritin is reported in micrograms per Liter. Absolute change in Serum Ferritin from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw.|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.|||µg/L||Standard Deviation|Mean
2840546|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level Measured From Core Study Baseline (BL) to End of Extension Study|Serum Levels were assessed at core study baseline (BL), 1 year, 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study) in monthly intervals. Serum Ferritin is reported in micrograms per Liter (µg/L).|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study.|||µg/L||Standard Deviation|Mean
2840547|NCT00171301|Primary|Absolute Change in Liver Iron Concentration (LIC)Measured by Liver MRI or Liver Biopsy From Core Study Baseline (BL) to End of Extension Study, by LIC Category|"Liver MRI or Liver Biopsy was performed at the core study baseline (BL) and then 1 year and 2 years in the core study, baseline of the extension study and time of discontinuation from the extension visit (end of study). Liver iron content (LIC) is reported in milligram Iron per gram dry weight (mg Fe/g dw).~Absolute change in LIC from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw."|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom LIC data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.|||mg Fe/g dw||Standard Deviation|Mean
2840548|NCT00171301|Primary|Percentage of Participants With Treatment Success From Core Baseline (BL) to Extension End of Study, by Baseline LIC Level and Age|Success was defined as the percentage of participants with decreased liver iron content (LIC) at the end of extension study compared to core baseline (BL) LIC. Success Criteria: For participants with Baseline LIC from 1 - <7 mg Fe/g dw, success was achieved if LIC level maintained at 1 - <7 mg Fe/g dw. For participants with Baseline LIC ≥7 - <10 mg Fe/g dw, success was achieved if LIC dropped to between 1 and < 7 mg Fe/g dw. For participants with Baseline LIC ≥10 mg Fe/g dw, success was achieved if LIC dropped by at least 3 mg Fe/g dw. LIC was measured by biopsy or magnetic resonance imaging.|From Core Study Baseline, to Extension End of Study, Up to 3 Years|The primary analysis will be on the intent-to-treat (ITT) population. ITT population includes all participants who performed the core end of study (EOS) visit evaluation and assessments and were included in the extension study. “n” is the number of participants analyzed in each category.|||percentage of participants||95% Confidence Interval|Mean
2840549|NCT00171210|Secondary|Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study|Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||mg/kg/day||Full Range|Median
2840550|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID|Relative change in liver iron content (LIC) measured by Superconducting Quantum Interfering Device (SQUID), calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.|||percent of start value||Full Range|Median
2840551|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID|Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Full Range|Median
2840552|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.|||percent of start value||Full Range|Median
2840553|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Full Range|Median
2840554|NCT00171210|Secondary|Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study.~(Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Percent change||Standard Deviation|Mean
2840555|NCT00171210|Secondary|Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study.~(Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Percent change||Standard Deviation|Mean
2840556|NCT00171210|Secondary|Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study.~(Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Percent change||Standard Deviation|Mean
2840557|NCT00171210|Secondary|Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study|Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||μg/L||Standard Deviation|Mean
2840578|NCT00170846|Post-Hoc|Change in mGFR by Baseline Calculated Creatinine Clearance (Cockcroft-Gault Formula)|"Cockcroft-Gault formula (CrCl):~Creatinine Clearance [mL/min] = CrCl (males) = (140 - A) * W / (72 * C) (males), CrCl (females) = CrCl (males) * 0.85,~Where:~A is age [years]~W is body weight [kg]~C is the serum concentration of creatinine [mg/dL]"|Baseline and 24 months|Per Protocol Population. The per-protocol (PP) population consisted of the ITT patients excluding those patients with major protocol deviations and those patients who were not able to initiate their randomized regimens as scheduled.|||mL/min||Standard Deviation|Mean
2840558|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID|Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Standard Deviation|Mean
2840559|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy|Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.|||mg Fe/g dw||Standard Deviation|Mean
2840560|NCT00171210|Primary|Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event|Adverse events results are based on preferred terms with at least 7% of participants in any group.|up to 5 years|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.|||Participants|||Number
2840561|NCT00171054|Secondary|Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38|Central Blood Pressure was measured via applanation tonometry recordings of the common carotid artery and from brachial oscillometric recordings. The Simultaneously obtained carotid artery pressure and standard brachial artery blood pressure are computed to obtain the central systolic pressure.|Baseline, Week 12 and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||mm Hg||Standard Error|Least Squares Mean
2840562|NCT00171054|Secondary|Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38||Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840563|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||EP||Standard Error|Least Squares Mean
2840564|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||EP||Standard Error|Least Squares Mean
2840565|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840566|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840567|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840594|NCT00169442|Secondary|Anti- PRP Antibody Concentrations|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2840569|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840570|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||percent||Standard Error|Least Squares Mean
2840571|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||Perfusion units||Standard Error|Least Squares Mean
2840572|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||Perfusion units||Standard Error|Least Squares Mean
2840573|NCT00171054|Primary|Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)|PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)|||m/s||Standard Error|Least Squares Mean
2840574|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.|For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group|||Percentage of Patients with an Event|||Number
2840575|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event|Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).|For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]|Intent-to-treat population: All randomized patients by assigned treatment group|||Percentage of Patients with an Event|||Number
2840576|NCT00170950|Primary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event|CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.|For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group|||Percentage of Patients with an event|||Number
2840577|NCT00170846|Secondary|Number of Participants With Safety Parameters|The selected safety parameters (such as hypertension, hyperlipidemia, diabetes mellitus, anemia, malignancies ) were derived based on adverse events preferred terms defined in the analysis plan.|24 months|Safety Population. The Safety Population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2840657|NCT00168844|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)|Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Percentage of erythrocytes||Standard Deviation|Mean
2840579|NCT00170846|Primary|Renal Function Assessed by Measured GFR (mGFR)|The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.|24 months|The modified ITT population included all ITT patients who had mGFR or calculated GFR (cGFR) at Month 24 based on all values including those collected after discontinuation of study medication.|||mL/min/1.73m^2||Standard Deviation|Mean
2840580|NCT00170625|Secondary|Progression-free Survival|progression-free survival according to kaplan-meier-estimator|after every third cycle, for up to one year||||months||95% Confidence Interval|Median
2840581|NCT00170625|Primary|Toxicity|hematological adverse events and non-hematological adverse events grade 3/4|after each cycle for up to one year||||participants|||Number
2840582|NCT00170157|Secondary|Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response|Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).|3 months|105 participants had follow-up PSA information; those without a follow-up PSA were excluded from this analysis.|||percentage of participants|||Number
2840583|NCT00170157|Primary|Number of Participants Progression-free at 18 Months|PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart.|18 months from the start of AA therapy||||participants|||Number
2840584|NCT00169442|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 9.5)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2840585|NCT00169442|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-Day (Day 0-30) follow-up period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2840586|NCT00169442|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-Day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2840587|NCT00169442|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-Day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2840588|NCT00169442|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-Day (Days 0-3) post-PRP challenge|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2840589|NCT00169442|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-Day (Days 0-3) post-PRP challenge|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2840590|NCT00169442|Secondary|Anti-BPT Antibody Concentrations.|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2840591|NCT00169442|Secondary|Anti-HBs Antibody Concentrations.|Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2840619|NCT00168844|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)|||Points on a scale||Standard Error|Mean
2840595|NCT00169442|Secondary|Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840596|NCT00169442|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840597|NCT00169442|Secondary|Seroprotection Rates for Anti-D Antibodies|The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Proportion||95% Confidence Interval|Number
2840598|NCT00169442|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value|The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840599|NCT00169442|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840600|NCT00169442|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.|At Month 0, prior to the PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840601|NCT00169442|Primary|Anti-BPT Antibody Concentrations|Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2840602|NCT00169442|Primary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2840603|NCT00169442|Primary|Anti-D and Anti-T Antibody Concentrations|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2840604|NCT00169442|Primary|Anti-PRP Antibody Concentrations.|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2840605|NCT00169442|Primary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.|At Month 1, post-PRP challenge|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2840606|NCT00169442|Primary|Number of Subjects With Booster Response to BPT Antigen|"The booster response was defined as:~an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or~at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose."|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840607|NCT00169442|Primary|Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)|A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840620|NCT00168844|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
2840608|NCT00169442|Primary|Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840609|NCT00169442|Primary|Seroprotection Rates for Anti-D Antibodies|The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Proportion||95% Confidence Interval|Number
2840610|NCT00169442|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840611|NCT00169442|Primary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.|At Month 1, post-booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840612|NCT00169442|Primary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL|The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.|At Month 1, post-PRP challenge|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
2840613|NCT00169104|Secondary|Safety of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer|"Adverse events were graded per RECIST v4.0. There were two severe adverse events: Grade 3 mental status changes in one subject on the G-CSF arm, and Grade 3 febrile neutropenia in one subject on the Placebo arm.~Refer to Adverse Events Table for specifics."|14 weeks|19 subjects (11 on the G-CSF arm and 8 on the placebo arm) received at least two weeks of treatment on study and were evaluable for toxicity.|||Participants|||Count of Participants
2840614|NCT00169104|Secondary|Clinical Response Rate of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer|"19 subjects (11 on the G-CSF arm and 8 on the placebo arm) completed 14 weeks of treatment and completed restaging at that time.~Responses were evaluated by RECIST criteria."|14 weeks|19 subjects completed 14 weeks of treatment and underwent restaging at that timepoint.|||Participants|||Count of Participants
2840615|NCT00169104|Secondary|Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Chemotherapy, Trastuzumab, and G-CSF Against a Her-2 Overexpressing Target in Vitro|"Buffy coat effector cells were isolated by centrifugation from heparinized blood, washed, and counted. SKBR3 target cells were labeled with 51-Cr at 100 uCi per 5 x 105 cells for 1 hour at 37 C, washed and effector cells and target cells were plated at a ratio of 70:1 in 96 well microtiter plates, with trastuzumab 2 ug/ml and with no antibody. After addition of the target cells, the plate was centrifuged gently at 1200 rpm to pellet cells, the plate was incubated for 4 hours at 37C, and 100 uL of supernatant was measured on a gamma counter set for 51Cr counting for 1 minute per tube. Specific lysis in % is defined as follows:~% specific lysis = (counts released into the supernatant under experimental conditions - spontaneous counts released into the supernatant) / (maximum counts released into the supernatant - spontaneous counts released into the supernatant)~Specific lysis at Week 14 was compared to specific lysis at baseline for 17 patients with week 14 samples available."|Baseline and 14 weeks|17 of 19 subjects had results from ADCC assays from baseline and at week 14. Because subjects on both arms of the trial received the identical treatment with 12 weeks of vinorelbine and G-CSF after the initial two week randomization, it is appropriate to pool the results of the ADCC assays at the 14 week timepoint from both arms.|||percentage of specific lysis||Standard Deviation|Median
2840616|NCT00169104|Primary|Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Trastuzumab With Either G-CSF or a Saline Placebo Against a Her-2 Overexpressing Target in Vitro|"Buffy coat effector cells were isolated by centrifugation from heparinized blood, and washed and counted. SKBR3 target cells were labeled with 51-Cr at 100 uCi per 5 x 105 cells for 1 hour at 37 C, washed and effector cells and target cells were plated at a ratio of 70:1 in 96 well microtiter plates, with trastuzumab 2 ug/ml and with no antibody. After addition of the target cells, the plate was centrifuged gently at 1200 rpm to pellet cells, the plate was incubated for 4 hours at 37C, and 100 uL of supernatant was measured on a gamma counter set for 51Cr counting for 1 minute per tube. Specific lysis in % is defined as follows:~% specific lysis = (counts released into the supernatant under experimental conditions - spontaneous counts released into the supernatant) / (maximum counts released into the supernatant - spontaneous counts released into the supernatant)~Specific lysis at Day 12 was compared to specific lysis at baseline between the G-CSF group and the placebo group."|Baseline and 12 days|19 subjects were evaluable for response and toxicity, but only 17 subjects had evaluable specific lysis laboratory outcomes at baseline and at Day 12.|||percentage of specific lysis||Standard Deviation|Mean
2840617|NCT00168844|Secondary|PGR Score|"Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)|||Points on a scale||Standard Error|Mean
2840618|NCT00168844|Secondary|PGE Scores|"Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)|||Points on a scale||Standard Error|Mean
2840621|NCT00168844|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.~Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
2840622|NCT00168844|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Puffs||Standard Error|Mean
2840623|NCT00168844|Secondary|Weekly Mean Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
2840624|NCT00168844|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
2840625|NCT00168844|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840626|NCT00168844|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840627|NCT00168844|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840628|NCT00168844|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840629|NCT00168844|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||g/L||Standard Deviation|Mean
2840630|NCT00168844|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
2840631|NCT00168844|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
2840632|NCT00168844|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
2840633|NCT00168844|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||micromoles per litre (umol/L)||Standard Deviation|Mean
2840634|NCT00168844|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
2840635|NCT00168844|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
2840636|NCT00168844|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
2840637|NCT00168844|Secondary|Change From Baseline in Lactic Dehydrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
2840638|NCT00168844|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
2840639|NCT00168844|Secondary|Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
2840640|NCT00168844|Secondary|Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Units per litre (U/L)||Standard Deviation|Mean
2840641|NCT00168844|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
2840642|NCT00168844|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||millimoles per litre (mmol/L)||Standard Deviation|Mean
2840643|NCT00168844|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840644|NCT00168844|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840645|NCT00168844|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840658|NCT00168844|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
2840659|NCT00168844|Secondary|Change From Baseline in VPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
2840660|NCT00168844|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
2840661|NCT00168844|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
2840662|NCT00168844|Secondary|Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
2840663|NCT00168844|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
2840664|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||bpm||Standard Deviation|Mean
2840665|NCT00168844|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840666|NCT00168844|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840667|NCT00168844|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840668|NCT00168844|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840669|NCT00168844|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||milliseconds (msec)||Standard Deviation|Mean
2840670|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||beats per minute (bpm)||Standard Deviation|Mean
2840671|NCT00168844|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.~For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.|||Number of exacerbations per patient year||Standard Deviation|Mean
2840672|NCT00168844|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9~For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
2840673|NCT00168844|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
2840674|NCT00168844|Primary|Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)|Trough Forced Expiratory Volume in 1 second (FEV1)|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840675|NCT00168831|Secondary|PGR Scores|Patient's Global rating (PGR) scores over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)|||Points on a scale||Standard Error|Mean
2840676|NCT00168831|Secondary|PGE Scores|Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)|||Points on a scale||Standard Error|Mean
2840677|NCT00168831|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period.~Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)|||Points on a scale||Standard Error|Mean
2840678|NCT00168831|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
2840679|NCT00168831|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.~Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
2840680|NCT00168831|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Puffs||Standard Error|Mean
2840681|NCT00168831|Secondary|Weekly Mean Morning Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
2840682|NCT00168831|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)|||Litres/minute||Standard Error|Mean
2840683|NCT00168831|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840684|NCT00168831|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840685|NCT00168831|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840686|NCT00168831|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840687|NCT00168831|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||g/L||Standard Deviation|Mean
2840688|NCT00168831|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
2840689|NCT00168831|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
2840690|NCT00168831|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||umol/L||Standard Deviation|Mean
2840691|NCT00168831|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||micromoles per litre (umol/L)||Standard Deviation|Mean
2840692|NCT00168831|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
2840693|NCT00168831|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
2840694|NCT00168831|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
2840695|NCT00168831|Secondary|Change From Baseline in Lactic Dehyrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
2840696|NCT00168831|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
2840697|NCT00168831|Secondary|Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||U/L||Standard Deviation|Mean
2840698|NCT00168831|Secondary|Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Units per litre (U/L)||Standard Deviation|Mean
2840699|NCT00168831|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||mmol/L||Standard Deviation|Mean
2840703|NCT00168831|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840704|NCT00168831|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840705|NCT00168831|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840706|NCT00168831|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840707|NCT00168831|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840708|NCT00168831|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840709|NCT00168831|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840710|NCT00168831|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||percentage of white blood cell count||Standard Deviation|Mean
2840711|NCT00168831|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/L||Standard Deviation|Mean
2840712|NCT00168831|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^9/Litre (L)||Standard Deviation|Mean
2840713|NCT00168831|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||10^12/Litre (L)||Standard Deviation|Mean
2840714|NCT00168831|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||grams per litre (g/L)||Standard Deviation|Mean
2840715|NCT00168831|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)||Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set|||Percentage of erythrocytes||Standard Deviation|Mean
2840716|NCT00168831|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
2840717|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
2840718|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
2840719|NCT00168831|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||pairs per 24 hours||Standard Deviation|Mean
2840720|NCT00168831|Secondary|Change From Baseline in SVPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||events per 24 hours||Standard Deviation|Mean
2840721|NCT00168831|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||premature beats per 24 hours||Standard Deviation|Mean
2840722|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||bpm||Standard Deviation|Mean
2840723|NCT00168831|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840724|NCT00168831|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840725|NCT00168831|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840726|NCT00168831|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||msec||Standard Deviation|Mean
2840727|NCT00168831|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||milliseconds (msec)||Standard Deviation|Mean
2840728|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)|||beats per minute (bpm)||Standard Deviation|Mean
2840729|NCT00168831|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year~For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.|||Number of exacerbations per patient year||Standard Deviation|Mean
2840730|NCT00168831|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9~For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)|||Points on a scale||Standard Error|Mean
2840731|NCT00168831|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|||Points on a scale||Standard Error|Mean
2840732|NCT00168831|Primary|Change From Baseline in Trough FEV1 After 48 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)|||Litres||Standard Error|Mean
2840733|NCT00168818|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients|||participants|||Number
2840734|NCT00168818|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1||||mL||Standard Deviation|Mean
2840735|NCT00168818|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1||||participants|||Number
2840736|NCT00168818|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 31-38 days|Treated set|||Participants|||Number
2840737|NCT00168818|Secondary|Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|end of treatment to day 91±7|Patients with any data available during follow-up|||Participants|||Number
2840738|NCT00168818|Secondary|Death During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
2840739|NCT00168818|Secondary|Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
2840740|NCT00168818|Secondary|Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
2840741|NCT00168818|Secondary|Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
2840742|NCT00168818|Secondary|Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
2840743|NCT00168818|Secondary|Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)|||Participants|||Number
2840759|NCT00168454|Secondary|Maximum Cystometric Capacity (MCC) by Urodynamic Measurements|Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters|Baseline, Week 12|Intent to Treat|||milliliters|||Number
2840760|NCT00168454|Secondary|Change in Number of Nocturia Episodes|Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.|Baseline, Week 12|Intent to Treat|||episodes|||Number
2840744|NCT00168818|Primary|Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 31-38 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)|||Participants|||Number
2840745|NCT00168805|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients|||participants|||Number
2840746|NCT00168805|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1||||mL||Standard Deviation|Mean
2840747|NCT00168805|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1||||participants|||Number
2840748|NCT00168805|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 6-10 days|Treated set|||Participants|||Number
2840749|NCT00168805|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up|||Participants|||Number
2840750|NCT00168805|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op|||Participants|||Number
2840751|NCT00168805|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op|||Participants|||Number
2840752|NCT00168805|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
2840753|NCT00168805|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
2840754|NCT00168805|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
2840755|NCT00168805|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)|||Participants|||Number
2840756|NCT00168805|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 6-10 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)|||Participants|||Number
2840757|NCT00168454|Post-Hoc|Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes|Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36|Intent to Treat|||Percentage of patients|||Number
2840758|NCT00168454|Secondary|Incontinence Quality of Life Instrument (I-QOL)|Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.|Baseline, Week 2, Week 6, Week 12|Intent to Treat|||Units on a scale|||Number
2840761|NCT00168454|Secondary|Change in Number of Micturitions|Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.|Baseline, Week 2, Week 6, Week 12|Intent to Treat|||micturitions|||Number
2840762|NCT00168454|Primary|Change in Number of Urinary Urge Incontinence Episodes|Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12|Intent to Treat|||episodes|||Number
2840763|NCT00168428|Secondary|Percentage of Patients With Severe HIT-6 Impact Category Scores|Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).|Week 24|Intent to Treat|||Percentage of Patients|||Number
2840764|NCT00168428|Secondary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat|||Headache Episodes||Standard Deviation|Mean
2840765|NCT00168428|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting the ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat|||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
2840766|NCT00168428|Secondary|Change in Frequency of Moderate/Severe Headache Days|Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with >= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.|Baseline, Week 24|Intent to Treat|||Moderate/Severe Headache Days||Standard Deviation|Mean
2840767|NCT00168428|Secondary|Change in Total Cumulative Hours of Headache Occurring on Headache Days|Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] when the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat|||Hours||Standard Deviation|Mean
2840768|NCT00168428|Primary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat|||Headache Days||Standard Deviation|Mean
2840769|NCT00168389|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2840770|NCT00168389|Secondary|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Days|||Number
2840771|NCT00168389|Secondary|Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients with data at the time point|||Microns||Standard Deviation|Mean
2840772|NCT00168389|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2840773|NCT00168389|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
2840774|NCT00168389|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
2840803|NCT00168038|Secondary|Time to Platelet Response|Median time to reach a platelet count ≥ 50 x 10^9/L.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.|||days||Inter-Quartile Range|Median
2840775|NCT00168389|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2840776|NCT00168337|Post-Hoc|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2840777|NCT00168337|Post-Hoc|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Days|||Number
2840778|NCT00168337|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Microns||Standard Deviation|Mean
2840779|NCT00168337|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2840780|NCT00168337|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
2840781|NCT00168337|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients|||Letters||Standard Deviation|Mean
2840782|NCT00168337|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
2840783|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2840784|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2840785|NCT00168324|Primary|Cumulative Response Rate of 15 or More Letter Improvement|The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.|Up to 180 Days|Intent-to-Treat: all randomized patients|||Kaplan-Meier Estimate|||Number
2840786|NCT00168324|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients|||Microns (µm)||Standard Deviation|Mean
2840787|NCT00168324|Secondary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.|Day 90, Day 180|Intent-to-Treat: all randomized patients|||Number of Participants|||Number
2840788|NCT00168311|Primary|Scale for the Asessment of Negative Symptoms (SANS)|Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity.|3 weeks||||Scores on a scale||Standard Deviation|Mean
2840789|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2840790|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2840791|NCT00168298|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients|||Microns (µm)||Standard Deviation|Mean
2840792|NCT00168298|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Day 180|Intent-to-Treat: all randomized patients|||Number of Participants|||Number
2840793|NCT00168103|Secondary|Number of Vomiting Episodes||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Episodes per subject||Full Range|Median
2840794|NCT00168103|Other Pre-specified|Number of Subjects Receiving Rescue Study Medication||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Subjects|||Number
2840795|NCT00168103|Other Pre-specified|Time to Complete Resolution of All HAE Symptoms, Including Pain|Complete resolution of symptoms was determined by subject self-assessment.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Hours||Full Range|Median
2840796|NCT00168103|Secondary|Number of Subjects With Worsened Intensity of Clinical HAE Symptoms|Includes any worsening of intensity of at least 1 of the HAE symptoms present at baseline. Routinely checked symptoms included pain, nausea, vomiting, cramps, and diarrhea.|Baseline and between 2 and 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Subjects|||Number
2840797|NCT00168103|Primary|Time to Start of Relief of Symptoms From HAE Attack|The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.|||Hours||Full Range|Median
2840798|NCT00168064|Secondary|Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)|Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.|Baseline to end of therapy||||Percent of participants|||Number
2840799|NCT00168064|Secondary|Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks||Assessment made at Day 1 and every subsequent visit during treatment|||||||
2840800|NCT00168064|Primary|Ratio of Response Rates Based on CAILS|The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment|Assessment made at Day 1 and every subsequent visit during treatment|ITT|||percentage of participants|||Number
2840801|NCT00168038|Secondary|Maximum Platelet Level|Maximum absolute platelet count achieved over the duration of the study.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.|||10^9/L||Full Range|Median
2840802|NCT00168038|Secondary|Duration of Platelet Response|The number of days the platelet count remained ≥ 50 x 10^9/L.|up to 29 days|Analyzed for responders in the ITT population, i.e., only subjects with at least one platelet measurement ≥ 50 x 10^9/L after start of treatment|||days|Participants|Inter-Quartile Range|Median
2840804|NCT00168038|Secondary|Regression of Hemorrhage (Internal)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with internal bleeding at baseline and respective post-baseline assessment.|||participants|||Number
2840805|NCT00168038|Secondary|Regression of Hemorrhage (Nose)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with nose bleeding at baseline and respective post-baseline assessment.|||participants|||Number
2840806|NCT00168038|Secondary|Regression of Hemorrhage (Genitourinary Tract)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with genitourinary tract bleeding at baseline and respective post-baseline assessment.|||participants|||Number
2840807|NCT00168038|Secondary|Regression of Hemorrhage (Oral Cavity)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with oral cavity bleeding at baseline and respective post-baseline assessment.|||participants|||Number
2840808|NCT00168038|Secondary|Regression of Hemorrhage (Skin)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|up to 29 days|The number of participants analyzed represents the number of subjects in the ITT population with skin bleeding at baseline and respective post-baseline assessment.|||participants|||Number
2840809|NCT00168038|Primary|Platelet Response|The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.|7 days|Intention to treat (ITT) analysis. The ITT population comprised all subjects who received at least once study medication.|||Percent of participants||95% Confidence Interval|Number
2840810|NCT00167934|Primary|Effects of Medication on Insulin Secretion at Skeletal Muscle (Glucose Disposal)||Measured at baseline and Week 12||||percent change||Standard Deviation|Mean
2840811|NCT00167934|Primary|Change From Baseline in Total Body Fat Composition Using Dual Energy X-ray Absorptiometry at 12 Weeks|Change in body composition (total body fat) was assessed using dual energy x-ray absorptiometry|Measured at baseline and Week 12||||percent change||Standard Deviation|Mean
2840812|NCT00167778|Secondary|How Bothersome Was Your Pain?|"The residual limb pain grade scores ranged from 0 No Pain/ Interference to 10 Severe Pain/Interference."|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
2840813|NCT00167778|Secondary|Pain Interference With Activities?|"The residual limb pain grade scores ranged from 0 No Pain/ Interference to 10 Severe Pain/Interference."|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
2840814|NCT00167778|Secondary|Least Residual Limb Pain?|"The residual limb pain grade scores ranged from 0 No Pain/ Interference to 10 Severe Pain/Interference."|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
2840815|NCT00167778|Secondary|Worst Residual Limb Pain?|"The residual limb pain grade scores ranged from 0 No Pain/ Interference to 10 Severe Pain/Interference."|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
2840816|NCT00167778|Secondary|Average Residual Limb Pain?|"The residual limb pain grade scores ranged from 0 No Pain/ Interference to 10 Severe Pain/Interference."|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
2840817|NCT00167778|Secondary|Residual Limb Pain at Present?|"The residual limb pain grade scores ranged from 0 No Pain/ Interference to 10 Severe Pain/Interference."|Measurements were taken after wearing the study prostheses for four weeks|10 participants wore both study prostheses but only 7 participants presented with pain.|||units on a scale||Standard Error|Mean
2840818|NCT00167778|Secondary|Six-minute Walk Distance|Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps.|Six minutes after wearing the study prostheses for four weeks.|Each participant wore both study prostheses.|||m||Standard Error|Mean
2840819|NCT00167778|Secondary|Activity Level|Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter)|One week|Each participant wore both study prostheses.|||Steps/day||Standard Error|Mean
2840820|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
2840821|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
2840822|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
2840823|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
2840824|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
2840825|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||N*mm/kg||Standard Deviation|Mean
2840826|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840827|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840828|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840829|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840830|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840831|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840852|NCT00167245|Primary|Number of Heavy Drinking Days|Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women|13 weeks||||number of heavy drinking days||Standard Error|Mean
2840853|NCT00167245|Primary|Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial|Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.|Last 3 weeks of 13 week trial||||Percent of participants|||Number
2840832|NCT00167778|Primary|Local Dynamic Stability (Ankle During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840833|NCT00167778|Primary|Local Dynamic Stability (Knee During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840834|NCT00167778|Primary|Local Dynamic Stability (Hip During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.|||dimensionless||Standard Deviation|Mean
2840835|NCT00167544|Secondary|Survival Without Severe Bronchopulmonary Dysplasia (BPD)|Using the NIH Consensus definition (Jobe A, 2001)|36 weeks postmenstrual age||||participants|||Number
2840836|NCT00167544|Secondary|Duration of Oxygen Requirement||Up to 36 weeks PMA||||days||95% Confidence Interval|Mean
2840837|NCT00167544|Secondary|Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure)||Up to 36 weeks PMA||||days||95% Confidence Interval|Mean
2840838|NCT00167544|Secondary|Regional Brain Volumes|Cerebral white matter volume|38-weeks postmenstrual age|In addition to the reasons cited for the primary outcome, one infant in the hydrocortisone group and two in the placebo group had artifacts on brain MRI precluding cerebral white matter segmentation and volume determination.|||cm^3||Standard Deviation|Mean
2840839|NCT00167544|Primary|Total Cerebral Volume as Measured by Volumetric Brain MRI|Total cerebral volume included all brain gray matter and white matter, including cerebellum.|38 weeks postmenstrual age (PMA)|Eight infants died in each group prior to term MRI precluding a determination of brain volumes. Additionally, four infants had poor quality MRI scans that could not be analyzed for brain volumes.|||cm^3||Standard Deviation|Mean
2840840|NCT00167414|Secondary|Number of Participants Who Experienced a Grade 4 or 5 Toxicity|Number of participants who experienced a grade 4 or 5 toxicity|6 years||||Participants|||Count of Participants
2840841|NCT00167414|Secondary|Percent of Patients With Lesion Local Control|Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.|6 years||||percentage of participants|||Number
2840842|NCT00167414|Primary|Overall Survival|The percent of patients that survived from date of enrollment until 6 year follow-up visit|6 years||||percentage of participants|||Number
2840843|NCT00167414|Primary|Overall Survival|The percent of patients that survived from date of enrollment until 4 year follow-up visit|4 years||||percentage of participants|||Number
2840844|NCT00167414|Primary|Overall Survival|The percent of patients that survived from date of enrollment until 2 year follow-up visit.|2 years||||percentage of participants|||Number
2840845|NCT00167388|Primary|Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States|Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion|1 hour|the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion)|||cm/sec||Standard Deviation|Mean
2840846|NCT00167310|Secondary|Plasma Cholesterol Levels in Various Lipoprotein Fractions|Biochemical Measures: Plasma levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Lp(a) cholesterol, IDL-cholesterol, HDL3-cholesterol, VLDL1,2-cholesterol, and VLDL3-cholesterol.|4 months||||mg/dL||Standard Deviation|Mean
2840847|NCT00167310|Primary|Plasma Levels of Triglycerides and Lipoprotein Cholesterol|Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.|4 months|Plasma triglyceride levels|||mg/dL||Standard Deviation|Mean
2840848|NCT00167245|Secondary|The Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale During the Medication Treatment Phase, Compared to Placebo-treated Subjects.||13 weeks|||||||
2840849|NCT00167245|Secondary|Days Abstinent From Drinking, Frequency of Heavy Drinking Days, and Cocaine Use (Confirmed by Urine Drug Screen) as Measured by the Time Line Follow-Back During the Treatment Phase, Compared to Less Topiramate-adherent (<80% Pills Taken).||13 weeks|||||||
2840850|NCT00167245|Secondary|Fewer Days of Cocaine Use as Measured by the Time Line Follow Back in the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks|||||||
2840851|NCT00167245|Secondary|Days Abstinent From Drinking and Frequency of Heavy Drinking Days as Measured by the Time Line Follow-Back During the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks|||||||
2840854|NCT00167206|Secondary|Number of Patients Alive at 2 Years|Calculated from Day 1 of hematopoietic cell transplant to 2 years post-transplant.|2 years after transplant||||Participants|||Number
2840855|NCT00167206|Secondary|Number of Patients Alive at 1 Year|Calculated from Day 1 of hematopoietic cell transplant to 1 year post-transplant.|1 year after transplant||||Participants|||Number
2840856|NCT00167206|Secondary|Immune Reconstitution - Mean Value (2 Years)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 2 years post-transplant.|at 2 years after transplant||||Number of CD4 cells per microliter||Standard Deviation|Mean
2840857|NCT00167206|Secondary|Immune Reconstitution - Mean Value (1 Year)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 1 year post-transplant.|1 year post-transplant.||||Number of CD4 cells per microliter||Standard Deviation|Mean
2840858|NCT00167206|Secondary|Number of Patients Who Exhibited Regimen-related Toxicity (RRT)|Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. Regimen-related toxicity involves harmful effects in an organism through exposure to the treatment given.|1 year after hematopoietic cell transplant||||Participants|||Number
2840859|NCT00167206|Secondary|Number of Patients With Chronic Graft Versus-Host Disease (GVHD)|"Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|1 year after hematopoietic cell transplant||||Participants|||Number
2840860|NCT00167206|Secondary|Number of Patients With Acute Graft Versus-Host Disease (aGVHD)|"Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|Day 100 after hematopoietic cell transplant||||Participants|||Number
2840861|NCT00167206|Secondary|Number of Patients Who Exhibited Secondary Graft Failure|Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. A complication after Bone Marrow Transplant in which the transplanted stem cells do not grow in the recipient's bone marrow and thus do not produce new blood cells.|Day 100 after hematopoietic cell transplant||||Participants|||Number
2840862|NCT00167206|Primary|Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment|Calculated from Day 1 of hematopoietic cell transplant to Day 42 post-transplant. Hematopoietic recovery and engraftment is defined as the first of three consecutive days the patient's absolute neutrophil count is greater than or equal to 0.5X10^9/Liter.|Day 42 after hematopoietic cell transplant||||Participants|||Number
2840863|NCT00167180|Secondary|Number of Patients With Bone Marrow Aplasia|"Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells.~In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat."|Day 100||||Participants|||Count of Participants
2840864|NCT00167180|Secondary|Number of Patients With Acute Graft-Versus-Host Disease|Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100||||Participants|||Count of Participants
2840865|NCT00167180|Secondary|Number of Participants With Complete Remission|In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.|one year||||Participants|||Count of Participants
2840866|NCT00167180|Secondary|Number of Patients Alive Without Disease|The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|1 Year||||Participants|||Count of Participants
2840867|NCT00167180|Primary|Number of Patients Alive|"The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.~Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive."|1 Year||||Participants|||Count of Participants
2840868|NCT00167102|Primary|Number of Adverse Events|Number of any adverse event reported throughout the study, regardless of relation to study drug|24 weeks||||adverse events|||Number
2840869|NCT00167102|Primary|The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values|Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period in subjects with chronic severe scalp alopecia|24 weeks||||percentage of participants|||Number
2840870|NCT00166712|Secondary|Patient and Graft Survival Rates at 6 and 12 Months Post-transplant||At 6 & 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.||||||
2840871|NCT00166712|Secondary|Incidence of Donor Specific Hyporesponsiveness Allowing for the Conversion to Monotherapy|The proportion of subjects for both groups determine this measure: 1) Patients in tacrolimus arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesonsiveness at 9 months post-transplant (those staying on TAC+MMF) or 3 months post-convertion (converted from TAC+MMF to Sirolimus+MMF) will be weaned to MMF monotherapy; 2) Those in the sirolimus+MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.|At 6 & 9 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.||||||
2840872|NCT00166712|Secondary|Renal Function at 12 Months Post-transplant|Laboratory tests for renal function include creatinine or iothalamate glomerular filtration rate (GFR).|At 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.||||||
2840873|NCT00166712|Secondary|Severity of Acute Rejection During the First 6 and 12 Months Post-transplant|The diagnosis of rejection will be based on clinical symptoms and signs, laboratory tests, and confirmed by core renal allograft biopsy.|Months 6-12 post-transplant|Study was terminated due to efficacy and there is no data was collected for this outcome measure.||||||
2840874|NCT00166712|Primary|The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.|The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.|Within 12 months post kidney transplant|33 total subjects reached the 12 month participation mark.|||Participants|||Number
2840875|NCT00166517|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in~SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population|||Participants|||Number
2840876|NCT00166517|Primary|Serum Anti-Rotavirus IgA Response|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in~Serum IgA 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population|||Participants|||Number
2840877|NCT00166504|Primary|LDL-C Lowering Efficacy|LDL-C = low density lipoprotein cholesterol, measured in mg/dl.|6 weeks|Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.|||Percent Change from Baseline||Standard Deviation|Least Squares Mean
2840878|NCT00166439|Secondary|Progression-free Survival|The progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined by the NCI Sponsored IWG as a ≥ 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or nonresponders and/or Appearance of any new lesion during or at the end of therapy.|Up to 10 years||||months||95% Confidence Interval|Median
2840879|NCT00166439|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 10 years||||months||95% Confidence Interval|Median
2840880|NCT00166439|Primary|Overall Response Rate After Two Cycles of ROAD|The overall response rate is defined as the percentage of patients who achieve a response after two cycles of oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD). A response was considered a Complete Response (CR) or Partial Response (PR) as defined by the NCI Sponsored International Working Group (IWG). CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses.|Up to 42 days||||percentage of patients||95% Confidence Interval|Number
2840881|NCT00166361|Primary|Mean Stent Dwell Time|Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.|baseline to 59 months after placement of stent||||months||Full Range|Mean
2840882|NCT00166296|Secondary|Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.|"The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.~We present data of de depression subscale. The seven-item Depression subscale yields a score of 0-21, with higher scores meaning higher levels of depressive symptoms."|12 weeks after interferon treatment onset||||Scores on a Scale||Standard Error|Mean
2840883|NCT00166296|Secondary|Total Score in the Montgomery-Asberg Depression Rating Scale|"The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.~Items are rated on a scale of 0-6. Scores range from 0 to 60, higher scores meaning higher levels of depression."|12 weeks after interferon treatment onset||||Scores on a scale||Standard Error|Mean
2840884|NCT00166296|Primary|Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).|"Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).~Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction."|Six months after the end of interferon treatment|Patients with available data for viral response 6 months after completion of interferon treatment were compared between treatment groups.|||Participants|||Number
2840885|NCT00166296|Primary|Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.|"At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.~At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation."|First three months of interferon treatment.|One of 67 patients allocated to the escitalopram group and 3 of 66 in placebo did not receive the first dose of study medications. Consequently, 66 patients treated with escitalopram and 63 with placebo were included in the intention to treat analysis, with a procedure of last observation carried forward (LOCF).|||Participants|||Number
2840886|NCT00166205|Secondary|Changes in Total Cholesterol|Changes in Total Cholesterol, at three-years post-operative minus baseline.|3 years||||Mg/dl||Standard Deviation|Mean
2840887|NCT00166205|Secondary|Changes in Low Density Lipoproteins (LDL)|Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.|3 years||||Mg/dl||Standard Deviation|Mean
2840888|NCT00166205|Secondary|Changes in High Density Lipoproteins (HDL)|Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.|3 year||||Mg/dl||Standard Deviation|Mean
2840889|NCT00166205|Primary|Percent Excess Weight Loss|Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.|3 Years Post Operative|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)|||Percent Excess Weight Loss||95% Confidence Interval|Mean
2841972|NCT00148733|Secondary|The Efficacy of Zinc in Malnourished and Non-malnourished Children|We will compare the efficacy of zinc in those that are stunted, wasted or underweight with those who are not.|Within 2 weeks after enrollment||2019-12-31|12/2019||||
2840890|NCT00166205|Secondary|Number of All Adverse Events of Subjects Implanted With the SAGB|The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).|3 Years||||Total Number of Adverse Events|||Number
2840891|NCT00166205|Secondary|Changes in Glycosylated Hemoglobin (HbA1c)|Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.|3 years||||Percent of total hemogloobin||Standard Deviation|Mean
2840892|NCT00166205|Secondary|Changes in Quality of Life (QOL) Measures|Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.|3 years||||Units on a scale||Standard Deviation|Mean
2840893|NCT00166205|Secondary|Change in Absolute Weight|Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.|3 years||||Pounds||Standard Deviation|Mean
2840894|NCT00166205|Secondary|Changes in Body Mass Index (BMI)|Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.|3 years||||kg/m2||Standard Deviation|Mean
2840895|NCT00166205|Secondary|Changes in Excess Body Weight (EBW)|Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.|3 years||||Pounds||Standard Deviation|Mean
2840896|NCT00166205|Primary|Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)|Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.|3 years|Intent to Treat (ITT)|||Percent of Subjects|||Number
2840897|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|60 minutes, 90 minutes|Only 10 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
2840898|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 11 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
2840899|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 18 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
2840900|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min|Baseline, 30 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.|||ng/mL||Standard Error|Mean
2840901|NCT00166166|Secondary|Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed.|5 minutes|Only 80 of the original 174 subjects were treated for this portion of the study.|||mL min^-1 * 100 mL^-1||Standard Error|Mean
2840902|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration.|5 minutes, 10 minutes|Only 19 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
2840903|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration.|5 minutes, 10 minutes|Only 15 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
2840904|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration.|Baseline, 5 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
2841291|NCT00159965|Secondary|Quality of Life in Epilepsy-31 (QOLIE-31)|This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2840905|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration.|5 minutes, 10 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
2840906|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
2840907|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.|||percent change||Standard Error|Mean
2840908|NCT00166114|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8|"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.~The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, Week 8||||participants|||Number
2840909|NCT00166036|Secondary|Change in Flow-mediated Dilatation (FMD)|Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline & 12 Weeks||||Percentage of brachial artery diameter||Standard Error|Mean
2840910|NCT00166036|Primary|Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels|Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline &12 Weeks||||nmol/mL||Standard Error|Mean
2840911|NCT00165984|Primary|Survival|Follow-up study designed to determine the impact of genetic factors on survival in single ventricle patients|7 yr mean follow-up|All patients enrolled were genotyped|||percentage of patients alive/nontrans|||Number
2840912|NCT00165984|Primary|To Evaluate the Incidence of the Pre-proendothelin SNP at Nucleotide 5665||7 years|165 enrolled patients were analyzed for this polymorphism|||participants|||Number
2840913|NCT00165958|Primary|Number of Participants With Cyst Recurrence|Recurrence of cyst after removal|16 months||||participants|||Number
2840914|NCT00165841|Secondary|The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month|6-month maintenance phase|||||||
2840915|NCT00165841|Secondary|The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase|6-month maintenance phase|||||||
2840916|NCT00165841|Primary|The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).|The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.|6 months double-blind maintenance phase|Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow.|||Percentage of Days||Standard Deviation|Mean
2840917|NCT00165789|Primary|Number of Participants With Any TEAE|Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.|Through end of study|Safety Population was the primary population for analysis defined as all subjects who completed the Baseline Phase and who received at least 1 dose of double-blind study medication.|||Participants|||Number
2840918|NCT00165789|Secondary|Duration of Dyskinesia From UPDRS at Baseline and Day 70|The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population|||Participants|||Number
2840919|NCT00165789|Secondary|Disability of Dyskinesia From UPDRS at Baseline and Day 70|The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population|||Participants|||Number
2840920|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Percentage of the Day||Standard Deviation|Mean
2840921|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Percentage of the Day||Standard Deviation|Mean
2840922|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Percentage of the Day||Standard Deviation|Mean
2840923|NCT00165789|Secondary|Change From Baseline to Day 70 in Goetz/Rush Score|The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks.|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Scores on a Scale||Standard Deviation|Mean
2840924|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Hours||Standard Deviation|Mean
2840925|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Hours||Standard Deviation|Mean
2840926|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Hour||Standard Deviation|Mean
2841024|NCT00163020|Primary|Use of Oxygen Therapy at 28 Days of Newborn Life|Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.|Measured at 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150))|||Twins|||Number
2840927|NCT00165789|Secondary|"Change From Baseline to Day 70 in on State of UPDRS Scores"|"The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the on and off state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the on fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease)."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.|||Scores on a Scale||Standard Deviation|Mean
2840928|NCT00165776|Secondary|Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment|Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline, Week 4|FAS|||Millimeters||Standard Error|Mean
2840929|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS|||Points on a Scale||Standard Error|Mean
2840930|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS|||Points on a Scale||Standard Error|Mean
2840931|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS|||Points on a Scale||Standard Error|Mean
2840932|NCT00165776|Primary|Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, Week 4|Full Analysis Set (FAS) population: All subjects who received study treatment|||Points on a Scale||Standard Error|Mean
2840933|NCT00165776|Secondary|Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment|Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Week 4|FAS|||Millimeters||Standard Error|Mean
2840934|NCT00165776|Secondary|Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment|"Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: Considering all the ways your cervical dystonia affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 4|FAS|||Millimeters||Standard Error|Mean
2840935|NCT00165698|Secondary|Height (Meter)||Baseline and 12 months|Per Protocol Set (PPS)|||meters||Standard Deviation|Mean
2840936|NCT00165698|Secondary|New Fracture and Fall||12 months|Per Protocol Set (PPS)|||participants|||Number
2840937|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of UCOC/OC||Inter-Quartile Range|Median
2840938|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of UCOC||Inter-Quartile Range|Median
2840939|NCT00165698|Secondary|Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of OC||Inter-Quartile Range|Median
2840940|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMC||Full Range|Median
2840941|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMC||Full Range|Median
2840942|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMD||Full Range|Median
2840943|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMD||Full Range|Median
2840944|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)|||percentage of BMD||Full Range|Median
2840945|NCT00165672|Primary|The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).|Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.|Baseline and 4 weeks|The major endpoint of this study was analysed in the population for clinical pharmacology data (observation period and treatment period)|||Percent Time||Standard Deviation|Mean
2841572|NCT00154297|Secondary|Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period|A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.|Month 12|Intention to treat (ITT) population.|||Participants|||Number
2840946|NCT00165646|Primary|Percentage of Participants With Complete Relief of Heartburn at Final Evaluation|"Heartburn diary will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days"|4 weeks|The major endpoint of this study was between-group comparison of the complete relief of heartburn (at the completion of the treatment period) in the full analysis set (FAS).|||Percentage of participants|||Number
2840947|NCT00165503|Primary|Adjuvant Chemotherapy Completion Rate|Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.|Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.|None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.||||||
2840948|NCT00163657|Primary|Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure|Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence|12 month post transplant||||participants|||Number
2840949|NCT00163657|Primary|Freedom From Acute Rejection or HCV Recurrence or Treatment Failure|"Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"|12 months||||participants|||Number
2840950|NCT00163293|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
2840951|NCT00163293|Secondary|Number of Participants With Clinically Significant Laboratory Values|Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin <9.5 g/dL; Erythrocytes <3.0 x 10^6/μL or >6.5 x 10^6/μL; White Blood Count <3000/mm^3 or >20000/mm^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose >2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase >3 times ULNR; Creatinine >1.5 times ULN; Potassium >5.0 mmol/L or <3.0 mmol/L; and Sodium >150 mmol/L or 130 mmol/L.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
2840952|NCT00163293|Secondary|Number of Participants With Clinically Significant Physical Examination Findings|A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
2840953|NCT00163293|Secondary|Number of Participants With Clinically Significant Vital Signs Findings|Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure >130 mmHg or <80 mmHg or a >20 mmHg difference from Baseline; Diastolic Blood Pressure > 85 mmHg; and Resting Heart Rate >140 bpm or <60 bpm or a >30 bpm difference from Baseline.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||participants|||Number
2840954|NCT00163293|Secondary|Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)|"The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby 1 indicated maximum impairment and 7 indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best)."|Months 2, 6 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2840955|NCT00163293|Secondary|Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])|"The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where 1 indicated maximum impairment and 7 indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best)."|Months 2, 6 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2842402|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42|Estimated FEV1 after bronchodilator at Month 42|Month 42||||L||Standard Error|Mean
2840956|NCT00163293|Secondary|Percentage of Asthma Symptom Free Days|Days without Asthma Symptom documented in the participant's diary were reported.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percentage of days||Standard Deviation|Mean
2840957|NCT00163293|Secondary|Percentage of Rescue Medication Free Days|Days without use of rescue medication documented in the participant's diary were reported.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percentage of days||Standard Deviation|Mean
2840958|NCT00163293|Secondary|Rescue Medication Use Per Day|Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||puffs/day||Standard Deviation|Mean
2840959|NCT00163293|Secondary|Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms|Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percentage of nights||Standard Deviation|Mean
2840960|NCT00163293|Secondary|Total Asthma Symptom Score by Diary Entries|Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2840961|NCT00163293|Secondary|Change From Baseline in Diurnal PEF Fluctuation|Diurnal PEF Fluctuation is equal to [(Higher PEF - Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percent fluctuation||Standard Deviation|Mean
2840962|NCT00163293|Secondary|Change From Baseline in PEF by Diary Entries|PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||liters/second||Standard Deviation|Mean
2840963|NCT00163293|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries|PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.|Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||liters/second||Standard Deviation|Mean
2840964|NCT00163293|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)|FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||percent predicted FEV1||Standard Deviation|Mean
2840965|NCT00163293|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)|FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.|Baseline and Months 1, 2, 4, 6, 8, 10 and 12|"ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. n in the category is the number of participants with data available at the given time-point."|||liters||Standard Deviation|Mean
2840966|NCT00163293|Secondary|Percentage of Participants Who Dropped-out Due to Asthma Exacerbation||Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||percentage of participants|||Number
2840967|NCT00163293|Secondary|Number of Exacerbations Per Participant|The mean number of asthma exacerbations per participant is reported.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||exacerbations||Standard Deviation|Mean
2842403|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42||Month 42||||L||Standard Error|Mean
2840968|NCT00163293|Secondary|Duration of Exacerbations|Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||days||Standard Deviation|Mean
2840969|NCT00163293|Secondary|Mean Rate of Asthma Exacerbations Per Year|Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||number of exacerbations per year||Standard Deviation|Mean
2840970|NCT00163293|Secondary|Growth Velocity as Assessed by Stadiometric Height Measurement|Standing height measured in millimeters (mm) with a wall-mounted stadiometer.|Up to 12 months|Safety analysis set included all randomized participants who received at least 1 dose of trial medication.|||mm/year||Standard Deviation|Mean
2840971|NCT00163293|Primary|Exacerbations (Post-hoc Analysis of Annual Rates)|A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [years] and race were identified to be important beside treatment. The parameters centre and age [years] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.|Up to 12 months|ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||number of events per year||Standard Error|Least Squares Mean
2840972|NCT00163293|Primary|Time to First Asthma Exacerbation|Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.|Up to 12 months|Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.|||days||Standard Error|Mean
2840973|NCT00163215|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies those participants evaluated at that time point.|||ratio||Standard Deviation|Mean
2840974|NCT00163215|Secondary|Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||years||Standard Deviation|Mean
2840975|NCT00163215|Secondary|Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||kg/m^2||Standard Deviation|Mean
2840976|NCT00163215|Secondary|Body Mass Index (BMI)|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2840977|NCT00163215|Secondary|Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840978|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Standard Deviation|Mean
2841573|NCT00154297|Secondary|Duration of Dialysis|The mean duration in days of any dialysis session that occurred within the 12 month treatment period.|12 months|The number of patients analyzed includes those with any dialysis in the 12 month period|||Days||Standard Deviation|Mean
2840979|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population|Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||SDS||Standard Deviation|Mean
2840980|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36|Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height-reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840981|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840982|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36|Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height - reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement - Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840983|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840984|NCT00163215|Secondary|Change From Baseline in Height at Month 12, Month 24 and Month 36|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||cm||Standard Deviation|Mean
2840985|NCT00163215|Secondary|Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|"ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here n signifies those participants evaluated at that time point."|||cm||Standard Deviation|Mean
2840986|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||cm/year||Standard Deviation|Mean
2840987|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||centimeter per year (cm/year)||Standard Deviation|Mean
2840988|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840989|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y[x-1])/([date of Yx-date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.|||SDS||Standard Deviation|Mean
2840990|NCT00163189|Other Pre-specified|Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60|Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT).|Screening, Month 12, 24, 36, 48, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||milli mole per liter (mmol/L)||Standard Deviation|Mean
2840991|NCT00163189|Other Pre-specified|Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels||Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2840992|NCT00163189|Other Pre-specified|Number of Participants Who Received Concomitant Medications||Baseline up to Month 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
2840993|NCT00163189|Other Pre-specified|Number of Participants With at Least 1 Medical or Surgical History||Screening|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
2840994|NCT00163189|Other Pre-specified|Number of Participants With Significant Changes in Physical Examinations|Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement;|Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
2840995|NCT00163189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs.|Baseline up to 28 days after last study treatment|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.|||participants|||Number
2840996|NCT00163189|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||ratio||Standard Deviation|Mean
2840997|NCT00163189|Secondary|Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||months||Standard Deviation|Mean
2840998|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
2841022|NCT00163020|Primary|Newborn Pneumonia|Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia|measure during the first 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154))|||Twins|||Number
2840999|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.|Baseline, Month 12, 24, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
2841000|NCT00163189|Secondary|Change From Baseline in Height at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||cm||Standard Deviation|Mean
2841001|NCT00163189|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||kg/m^2||Standard Deviation|Mean
2841002|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)|GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
2841003|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)|GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.|Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
2841004|NCT00163189|Secondary|Annual Growth Rate (AGR)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx-height Y{x-1}] / ([date of Yx - date of Y{x-1}] /365.25). Yx refers to the value at particular timepoint x.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||cm/year||Standard Deviation|Mean
2841005|NCT00163189|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||SDS||Standard Deviation|Mean
2841006|NCT00163189|Secondary|Mean Height|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||centimeters (cm)||Standard Deviation|Mean
2841007|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.|Baseline, Month 36|"PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. n=participants evaluable at the specified time point."|||SDS||Standard Deviation|Mean
2841023|NCT00163020|Primary|Newborn Sepsis|Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.|measured during the first week following birth|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol.|||participants|||Number
2841574|NCT00154297|Secondary|Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period|The number of patients who underwent any dialysis within the 12-month treatment period.|Month 12|Intention to treat (ITT) population.|||Participants|||Number
2841008|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12.|Baseline, Month 36|"Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2841009|NCT00163020|Primary|Perinatal Death|Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.|measured from randomization to 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156))|||Twins|||Number
2841010|NCT00163020|Secondary|Participant Side Effects Requiring Cessation of Therapy|Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy.|anytime from initial injection to final injection at 34 weeks.|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)|||participants|||Number
2841011|NCT00163020|Secondary|Participant Drop-out Rates|Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy).|any time from randomization to completion of final dose of study medication|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)|||participants|||Number
2841012|NCT00163020|Secondary|Newborn Birthweight|Newborn Birthweight within the twins group was measure following delivery and noted in grams.|measure following delivery|Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80)|||grams||Standard Deviation|Mean
2841013|NCT00163020|Secondary|Newborn Gestational Age (GA) at Delivery|Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.|determined at the time of birth|Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80)|||weeks of age for twin pregnancy||Standard Deviation|Mean
2841014|NCT00163020|Secondary|Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks|Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)|noted at delivery|Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80)|||Triplet Pregnancies|||Number
2841015|NCT00163020|Secondary|Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks|Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks)|Gestational age noted at time of birth|Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80)|||Twin Pregnancies|||Number
2841016|NCT00163020|Secondary|Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)|Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death).|measured as any event noted in the first 28 day following birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155))|||Twins - Components of Neonatal Morbidity|||Number
2841017|NCT00163020|Primary|Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver|Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).|measured during the first 28 days after delivery|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130))|||Twins|||Number
2841018|NCT00163020|Primary|Newborn Retinopathy of Prematurity (ROP)|Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.|measured during the first 28 day after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145))|||Twins|||Number
2841019|NCT00163020|Primary|Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery|Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.|measured in the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152))|||Twins|||Number
2841020|NCT00163020|Primary|Newborn Periventricular Leukomalacia (PVL)|Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.|measured in the first 28 days after birth.|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol.|||participants|||Number
2841021|NCT00163020|Primary|Newborn Intraventricular Hemorrhage Grade 3 or 4|"Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation.~Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension."|measured during the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152))|||Twins|||Number
2841025|NCT00163020|Primary|Newborn Respiratory Distress Syndrome (RDS)|"Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support.~Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used.~Morbidity measures were based on live births with data available for the outcomes."|Measured from delivery until 30 days after baby was discharged from the hospital|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153))|||Twins|||Number
2841026|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 7|MITT population, baseline evaluations compared to Week 7 evaluations.|||participants|||Number
2841027|NCT00162981|Primary|A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 4-week maintenance period|MITT population|||Percent Reduction||Full Range|Median
2841028|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 3|MITT population, baseline evaluations compared to Week 3 evaluations.|||participants|||Number
2841029|NCT00162981|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period||||Percent of participants|||Number
2841030|NCT00162981|Primary|Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period|Modified Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period.|||Percent Reduction||Standard Deviation|Mean
2841031|NCT00162942|Post-Hoc|Clinical Response Based on no Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who did not use 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841032|NCT00162942|Post-Hoc|Clinical Response Based on Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who used 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medication were considered a treatment failure.|||percentage of participants|||Number
2841033|NCT00162942|Post-Hoc|Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who have not used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841034|NCT00162942|Post-Hoc|Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and previously used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841035|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score less than or equal to 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841036|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Greater Than 300|A clinical response is defined as a 70-point decrease in CDAI score.|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score greater than 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841037|NCT00162942|Secondary|Mean Change in C-Reactive Protein||Baseline to week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 value or Last Observation Carried Forward was used for the analysis.|||milligrams/liter||Standard Deviation|Mean
2841038|NCT00162942|Secondary|Mean Change in Subject Global Rating|7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841039|NCT00162942|Secondary|Mean Change in Crohn's Disease Endoscopic Index of Severity|26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|Endoscopic evaluations were to be performed at baseline and Week 12 on a subset of study subjects.|||units on a scale||Standard Deviation|Mean
2841040|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (WLQ Index)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841041|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Output Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841042|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841043|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Physical Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841044|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Time Management)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841045|NCT00162942|Secondary|Mean Change in EuroQol Score (Visual Analog Scale)|101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841046|NCT00162942|Secondary|Mean Change in EuroQol Score (Single Index)|A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841047|NCT00162942|Secondary|Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)|193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841048|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841049|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.|||units on a scale||Standard Deviation|Mean
2841629|NCT00153803|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed up to 50 months|NA = not available; The data cannot be located/provided due to the PI leaving the institution.|||Months||Full Range|Median
2841050|NCT00162942|Secondary|Clinical Response|Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12|Baseline to Week 12|All subjects who received at least one apheresis session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 CDAI score or Last Observation Carried Forward was used for the analysis. Subjects with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841051|NCT00162942|Secondary|CDAI Score Change From Baseline|601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score was used for the analysis. If no week 12 score, then the week 9 score was be used. If no week 9 score, the subject was considered a treatment failure.|||units on a scale||Standard Deviation|Mean
2841052|NCT00162942|Primary|Frequency and Severity of Adverse Events Through Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.|Baseline through Week 12 Visit|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.|||percentage of participants|||Number
2841053|NCT00162942|Primary|Clinical Remission|Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT was used for effectiveness analysis. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.|||percentage of participants|||Number
2841054|NCT00162773|Primary|Changes in Free Serum IgE Levels From Baseline||baseline to 2 weeks|Data, if any, are not available as this study has been terminated as the PI has left the institution. The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.||||||
2841055|NCT00162370|Secondary|Determine the Cost-effectiveness of Using Stress Echocardiography in Screening Peri- and Post-menopausal Women at Intermediate Risk for Coronary Artery Disease.||End of Study|||||||
2841056|NCT00162370|Secondary|Determine the Relative Values of Exercise Echocardiography, Exercise ECG Testing, Cardiac Peptides and Brachial Artery Reactivity for Identifying Patients at Risk of Cardiac Events.||End of Study|||||||
2841057|NCT00162370|Secondary|Determine the Value of Brachial Artery Reactivity for Identifying Patients With Cardiac Events During Follow-up.||End of Study|||||||
2841058|NCT00162370|Secondary|Determine the Value of Exercise Induced Changes in Levels of Cardiac Peptides; Brain Natriuretic Peptide (BNP) in Identifying Patients With Cardiac Events During Follow-up.||2 year or 5 year follow up|||||||
2841059|NCT00162370|Secondary|Percent of Subjects With Abnormal Stress ECG Testing for Identifying Patients With Major Adverse Cardiac Events (MACE)|Stress ECG test interpretation will be summarized using number and percentage of patients with normal and abnormal ECG with and without MACE|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up|||percent of MACE|||Number
2841060|NCT00162370|Primary|Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE)|Determine the prognostic value of stress echocardiography as a screening examination in peri- or post-meopausal female patients with an intermediate pre-test likelihood of coronary artery disease (CAD) to identify patients at higer risk of experiencing future cardiac events.|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up|||% of subjects with MACE|||Number
2841061|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841062|NCT00162266|Secondary|Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841089|NCT00162266|Primary|Mean Change From Baseline (BL) in IgM in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
2841063|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841064|NCT00162266|Secondary|Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841065|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841066|NCT00162266|Secondary|Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841067|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841068|NCT00162266|Secondary|Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841069|NCT00162266|Secondary|Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841090|NCT00162266|Secondary|Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period|Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||IU/mL||Standard Error|Mean
2841070|NCT00162266|Secondary|Mean BL General Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841071|NCT00162266|Secondary|Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.|BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841072|NCT00162266|Secondary|Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841073|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841074|NCT00162266|Secondary|Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841075|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841076|NCT00162266|Secondary|Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841103|NCT00162266|Primary|Baseline Immunoglobulin M (IgM) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.|Baseline (Day 0) and Days 360, 720,1080,1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
2841077|NCT00162266|Secondary|Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.|Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841078|NCT00162266|Secondary|Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period|SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841079|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2841080|NCT00162266|Secondary|Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2841081|NCT00162266|Secondary|Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period|Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
2841082|NCT00162266|Secondary|Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period|Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
2841083|NCT00162266|Secondary|Mean Change From Baseline in sIL2-r Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||pg/mL||Standard Error|Mean
2841084|NCT00162266|Primary|Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
2841085|NCT00162266|Secondary|Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||pg/mL||Standard Deviation|Mean
2841086|NCT00162266|Primary|Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
2841087|NCT00162266|Primary|Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
2841088|NCT00162266|Primary|Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
2841643|NCT00153101|Secondary|TRANSCEND. New Microalbuminuria|TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841091|NCT00162266|Secondary|Baseline Level of Serum Rheumatoid Factor Over Time in OL Period|Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.|||IU/mL||Standard Deviation|Mean
2841092|NCT00162266|Secondary|Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period|The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.|Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N =number of participants analyzed; n=the number of participants with measurements for that time point.|||Participants|||Number
2841093|NCT00162266|Secondary|Number of ACR 70 Responders in the OL Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.|||Participants|||Number
2841094|NCT00162266|Secondary|Number of ACR 50 Responders in the OL Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.|||Participants|||Number
2841095|NCT00162266|Secondary|Number of ACR 20 Responders in OL Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2841096|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||ng/mL||95% Confidence Interval|Mean
2841097|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||ng/mL||95% Confidence Interval|Mean
2841098|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||ng/mL||95% Confidence Interval|Mean
2841099|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||pg/mL||95% Confidence Interval|Mean
2841100|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||pg/mL||95% Confidence Interval|Mean
2841101|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||IU/mL||95% Confidence Interval|Mean
2841102|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||participants|||Number
2842404|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36||||L||Standard Error|Mean
2841104|NCT00162266|Primary|Mean Change From Baseline (BL) in IgG Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
2841105|NCT00162266|Primary|Baseline Immunoglobulin G (IgG) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.|Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
2841106|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||participants|||Number
2841107|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||titers||Standard Deviation|Geometric Mean
2841108|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.|||titers||Standard Deviation|Geometric Mean
2841109|NCT00162266|Secondary|Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods||Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)|Treated Participants|||participants|||Number
2841110|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.|||Participants|||Number
2841111|NCT00162266|Primary|Mean Change From Baseline (BL) in IgA Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
2841112|NCT00162266|Primary|Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.|Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in DB study. n=the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
2841113|NCT00162266|Primary|Number of Participants With AEs of Special Interest in OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.|Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
2841114|NCT00162266|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.|Day 360 to Day 3060|All treated OL participants.|||Participants|||Number
2841115|NCT00162266|Primary|Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period|The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.|Day 360 to Day 3,060|All treated participants.|||Participants|||Number
2841116|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.|||Participants|||Number
2841117|NCT00162266|Secondary|Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.|From the start of study through the end of the double-blind period (at 12 months)|All treated participants|||Participants|||Number
2841118|NCT00162266|Secondary|Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360||Day 180, Day 360|All treated participants|||participants|||Number
2841119|NCT00162266|Secondary|Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360|A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||Percentage of Change on mHAQ scale||Standard Error|Mean
2841120|NCT00162266|Secondary|Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.|||units on a scale||Standard Error|Mean
2841121|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360|Percentage change = 100*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 360|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.|||percentage change||Standard Error|Mean
2841122|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180|Percentage change = 100*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 180|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.|||percentage change||Standard Error|Mean
2841123|NCT00162266|Secondary|ACR-N Area Under The Curve (AUC) on Day 180 and Day 360|The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.|Baseline and Day 180; Baseline and Day 360||||percentage*days||Standard Error|Mean
2841124|NCT00162266|Secondary|ACR Numeric Values (ACR-N)|The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication|||units on a scale||Standard Deviation|Mean
2841125|NCT00162266|Secondary|Number of ACR 70 Responders in DB Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication|||Participants|||Number
2841126|NCT00162266|Secondary|Number of ACR 50 Responders in DB Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication|||Participants|||Number
2841127|NCT00162266|Secondary|Number of ACR 20 Responders in DB Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360|Participants who received at least 1 infusion of study medication|||Participants|||Number
2841148|NCT00162097|Primary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])|The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||mcg*h/mL||Full Range|Geometric Mean
2841973|NCT00148733|Secondary|The Efficacy of Zinc According to Breast Feeding Status and in Different Age Categories|We will measure to what extent breastfeeding status modifies the effect of zinc on pneumonia|Within 2 weeks after enrollment||2019-12-31|12/2019||||
2841128|NCT00162266|Primary|Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 180|Intent-to-treat population. Participants who discontinued the study due to lack of efficacy (ie, worsening rheumatoid arthritis) were considered ACR 20 nonresponders at all subsequent time points. For all subjects who discontinued for other reasons, their last ACR 20 response was carried forward.|||Participants|||Number
2841129|NCT00162136|Secondary|Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.|At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.||||Participants|||Number
2841130|NCT00162136|Secondary|Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level|Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)|through 72 hours after start of infusion|All participants treated at the 40 mg/m2 dose level.|||ng/mL||Standard Deviation|Mean
2841131|NCT00162136|Secondary|Hematology Results - Worst On-Study Grade|Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.||||Participants|||Number
2841132|NCT00162136|Secondary|Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.||||Participants|||Number
2841133|NCT00162136|Primary|Number of Participants With Dose Limiting Toxicities at Dose Level|Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.|Measures taken at Cycle 01 (21-day cycle)|All treated participants|||participants|||Number
2841134|NCT00162123|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.|From day of first reinduction in current study to date of progression or death, whichever occurred first.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study|||Months||95% Confidence Interval|Median
2841135|NCT00162123|Secondary|Number of Participants With On-study Immune-related Adverse Events (irAEs)|irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.|From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study 10 mg/kg current study|||Participants|||Number
2841136|NCT00162123|Secondary|Percentage of Participants Surviving at 1, 1.5, and 2 Years|Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.|From first dose of study drug in parent study to up to 2 years after reinduction|All participants who received study drug as reinduction or extended maintenance from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study and those patients who were followed-up.|||Percentage of participants|||Number
2841137|NCT00162123|Secondary|Overall Survival (OS)|OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.|From first dose of study drug in parent study to death or date of last censoring.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study|||Months||95% Confidence Interval|Median
2841149|NCT00162097|Primary|Minimum Plasma Concentration (Cmin)|Cmin was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||mcg/mL||Full Range|Geometric Mean
2841210|NCT00160680|Secondary|Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During month 1 of the 6 months treatment period|Only patients with a valid T4SS at month 1 were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841138|NCT00162123|Primary|Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study|||Participants|||Number
2841139|NCT00162097|Secondary|Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)|The physical examination included an evaluation of the participant's height and body mass index (BMI) (at screening only), and weight. Abnormal physical examination are findings that are clinically meaningful by the judgment of the investigator|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis. Physical examination findings were not analysed at discharge.|||participants|||Number
2841140|NCT00162097|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. The investigator used his/her clinical judgement to decide whether or not abnormalities in vital signs were clinically meaningful.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
2841141|NCT00162097|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||hours||Full Range|Median
2841142|NCT00162097|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities are findings that are clinically meaningful by the judgment of the investigator. A 12-lead ECG was performed and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
2841143|NCT00162097|Secondary|Number of Participants With Urinalysis MAs|"MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following urinalysis MA definitions specify the criteria for MAs in the data presented. The presence of white blood cells (WBCs) and red blood cells (RBCs) in the urine was graded on a scale: 0 = no cells present (negative); trace =a small number of cells present; then 1+, 2+, 3+ and 4+, denoting increasingly positive urine results (ie, WBCs/RBCs present in the urine). The MA for both WBCs and RBCs was >= 2+ (or, if pre-treatment value >=2+, then >= 4+)."|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.|||participants|||Number
2841144|NCT00162097|Secondary|Number of Participants With Serum Chemistry MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify the criteria for MAs in the data presented. High bilirubin (total): >1.1 x ULN (or if pre-treatment value >ULN, then >1.25 x pre-treatment value). High creatinine: >1.33 x pre-treatment value. Low albumin: <0.9 x LLN (or if pre-treatment value <LLN, then <0.9 x pre-treatment value). High amylase (total): >2 x pre-treatment value.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 were included in the analysis. The 'n' signifies those participants who received study drug and were evaluated for this measure, for each group respectively.|||participants|||Number
2841145|NCT00162097|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Low platelet count: <0.85 x lower limit of normal (LLN) (or if pre-treatment value <LLN, then <0.85 x pre-treatment value). Low leukocytes: <0.9 x LLN (or if pre-treatment value <LLN, then <0.85 x pre-treatment value. If pre-treatment value >upper limit of normal [ULN], then <LLN). Low neutrophils+bands (absolute): <=1.500 10^3 cells/microliter (uL). Low lymphocytes (absolute): <0.750 10^3 cells/uL.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.|||participants|||Number
2841146|NCT00162097|Secondary|Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product. Participants who discontinued the study due to an AE were recorded.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
2841147|NCT00162097|Secondary|Number of Participants Who Experienced AEs|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.|||participants|||Number
2841162|NCT00161473|Primary|Mean Clinical Global Impression of Change (CGIC) at Last Observation|"The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates markedly improved, 4 indicates no change, and 7 indicates markedly worse."|Week 8|Participants with at least one follow-up behavioral assessment visit were included in this analysis|||units on a scale||Standard Deviation|Mean
2841150|NCT00162097|Secondary|Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)|An SAE was defined as any adverse event (AE) occurring at any dose that; resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.|All data from participants who signed the informed consent and enrolled in the study is included in the data set used for evaluating SAEs.|||Participants|||Number
2841151|NCT00162097|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.|||micrograms (mcg)/mL||Full Range|Geometric Mean
2841152|NCT00162032|Secondary|Predictive Value of Cardiolite For Cardiac Events|Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.|6 months|Efficacy Evaluable Population|||Participants|||Count of Participants
2841153|NCT00162032|Secondary|Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography|Sensitivity, specificity, PPV, and NPV of SDS for myocardial perfusion corresponding to the left anterior descending (LAD) for the diagnosis of IHD in the distribution of the left anterior descending (LAD) artery relative to coronary angiography based diagnosis were determined. Coronary stenoses of ≥ 50% for arteries associated with LAD territories were classified as LAD disease. SDS LAD > 1 was classified as positive for IHD for the LAD distribution.|24 hours||||proportion||95% Confidence Interval|Number
2841154|NCT00162032|Secondary|Incidence of Hard Cardiac Events|Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans.|3 years|All subjects who had undergone stress cardiac MPI studies|||participants|||Number
2841155|NCT00162032|Secondary|Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography|Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of myocardial perfusion imaging (MPI) for the diagnosis of ischemic heart disease (IHD) relative to coronary angiography. Coronary stenoses of ≥ 50% were classified as disease. SSS > 4 in MPI was classified as positive for IHD.|6 months|Per-protocol population of pooled adolescents and children who underwent coronary angiography|||proportion||95% Confidence Interval|Number
2841156|NCT00162032|Primary|Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.|The proportion of all patients who experienced cardiac events among patients with abnormal (SSS >=4, high risk) and normal (SSS <4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.|3 years|Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event|||proportion of participants||95% Confidence Interval|Number
2841157|NCT00161616|Secondary|Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)|"Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, healed (see primary outcome), and radiographically united by independent, blinded radiology panel, united. Patients deemed not healed or not united were assessed as failures."|1 year|All patients randomized were analyzed.|||patients|||Number
2841158|NCT00161616|Primary|Number of Patients With Healed Fractures|Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed.|13 and 20 weeks|All patients randomized were analyzed.|||patients|||Number
2841159|NCT00161473|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation|"The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms.~A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.~The mean group change was determined by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."|||units on a scale||Standard Deviation|Mean
2841160|NCT00161473|Secondary|Number of Behavioral Assessment Visits Completed|This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.|Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)||||number of visits||Standard Deviation|Mean
2841161|NCT00161473|Primary|Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation|"The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms.~A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.~The mean group change was calculated by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."|||units on a scale||Standard Deviation|Mean
2841170|NCT00161382|Primary|Initiation of Sexual Intercourse|The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.|Measured throughout the study, and at 2006/2007 school year||||participants|||Number
2841171|NCT00161213|Secondary|Overall Survival||5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.|||months||95% Confidence Interval|Median
2841172|NCT00161213|Secondary|1-year Survival Rate|Percentage of subjects who survive up to 1 year|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.|||percentage of total evaluable subjects||95% Confidence Interval|Number
2841173|NCT00161213|Secondary|Response Rate|"Response rate as defined by a best response of Stable Disease or better."|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response. Seven subjects were not assessed for response as they discontinued therapy treatment before response was assessed.|||percentage of total evaluable subjects||95% Confidence Interval|Number
2841174|NCT00161213|Primary|Progression-free Survival|Progression-free survival in months.|4 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.|||months||95% Confidence Interval|Median
2841175|NCT00160706|Secondary|Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256||Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 280 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||µg/g stool||95% Confidence Interval|Geometric Mean
2841176|NCT00160706|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||mg/L||95% Confidence Interval|Geometric Mean
2841177|NCT00160706|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)|Of the 310 subjects in the Safety Population, 309 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
2841178|NCT00160706|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|Of the 310 subjects in the Safety Population, 307 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||µg/mL||95% Confidence Interval|Geometric Mean
2841179|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 299 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
2841180|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 307 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
2841644|NCT00153101|Secondary|TRANSCEND. Progression to ESRD|TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m²|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841181|NCT00160706|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
2841182|NCT00160706|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
2841183|NCT00160706|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
2841184|NCT00160693|Secondary|Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years|This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
2841185|NCT00160693|Secondary|Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years||From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
2841186|NCT00160693|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Of the 402 subjects in the Safety Set (SS), 400 subjects are included in this analysis, because they had available data at Baseline and Completion or early Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
2841187|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).|||percentage of subjects||95% Confidence Interval|Number
2841188|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).|||percentage of subjects||95% Confidence Interval|Number
2841189|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).|||percentage of subjects||95% Confidence Interval|Number
2841198|NCT00160680|Secondary|Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During month 6 of the 6 months treatment period|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 6 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841190|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316|"The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 316|Of the 402 subjects in the Safety Set (SS), 140 subjects are included in this analysis, because they had available data at Baseline and Week 316.|||percentage of subjects||95% Confidence Interval|Number
2841191|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256|"The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 256|Of the 402 subjects in the Safety Set (SS), 211 subjects are included in this analysis, because they had available data at Baseline and Week 256.|||percentage of subjects||95% Confidence Interval|Number
2841192|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208|"The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 208|Of the 402 subjects in the Safety Set (SS), 223 subjects are included in this analysis, because they had available data at Baseline and Week 208.|||percentage of subjects||95% Confidence Interval|Number
2841193|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160|"The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 160|Of the 402 subjects in the Safety Set (SS), 247 subjects are included in this analysis, because they had available data at Baseline and Week 160.|||percentage of subjects||95% Confidence Interval|Number
2841194|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100|"The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 100|Of the 402 subjects in the Safety Set (SS), 275 subjects are included in this analysis, because they had available data at Baseline and Week 100.|||percentage of subjects||95% Confidence Interval|Number
2841195|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52|"The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 52|Of the 402 subjects in the Safety Set (SS), 370 subjects are included in this analysis, because they had available data at Baseline and Week 52.|||percentage of subjects||95% Confidence Interval|Number
2841196|NCT00160693|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
2841197|NCT00160693|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP up to 8 years|Safety Set (SS).|||percentage of subjects|||Number
2841209|NCT00160680|Secondary|Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During month 2 of the 6 months treatment period|Only patients with a valid T4SS at month 2 were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841199|NCT00160680|Secondary|Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During month 5 of the 6 months treatment period|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 5 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841200|NCT00160680|Secondary|Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During month 4 of the 6 months treatment period|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 4 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841201|NCT00160680|Secondary|Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During month 3 of the 6 months treatment period|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 3 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841202|NCT00160680|Secondary|Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During month 2 of the 6 months treatment period|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 2 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841203|NCT00160680|Secondary|Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During month 1 of the 6 months treatment period|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 1 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841204|NCT00160680|Secondary|Mean Weekly Individual Symptoms Scores During the Treatment Period|"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity."|During the treatment period until week 24|31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean weekly individual symptoms scores were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.|||units on a scale||Standard Error|Least Squares Mean
2841205|NCT00160680|Secondary|Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During month 6 of the 6 months treatment period|Only patients with a valid T4SS at month 6 were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841206|NCT00160680|Secondary|Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During month 5 of the 6 months treatment period|Only patients with a valid T4SS at month 5 were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841207|NCT00160680|Secondary|Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During month 4 of the 6 months treatment period|Only patients with a valid T4SS at month 4 were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841208|NCT00160680|Secondary|Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During month 3 of the 6 months treatment period|Only patients with a valid T4SS at month 3 were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841645|NCT00153101|Secondary|TRANSCEND. Doubling of Serum Creatinine|TRANSCEND. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841211|NCT00160680|Primary|Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period|The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.|During the treatment period until week 24|Only patients with a valid mean weekly T4SS during the treatment period were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2841212|NCT00160667|Secondary|Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Area Measured by the Investigator|Allodynia is pain due to a normally non-painful stimulus. The brush-evoked allodynia areas were assessed by the Investigator (location and contour of the allodynic regions drawn on a standard dermatomal map). Areas (mm²) of the allodynic regions drawn by the Investigator were afterwards computed by means of appropriate tools and calibrated templates. The larger the area in square centimeters the more allodynia. A negative value in percent change in the brush-evoked allodynia area indicates improvement.|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.|||percentage of change||Standard Deviation|Mean
2841213|NCT00160667|Secondary|Percent Change From Randomization Visit to the Evaluation / Early Discontinuation in the Brush-evoked Allodynia Intensity Rated by the Patient|"Brush-evoked allodynia intensity was assessed by the subject on an 11-point numerical rating scale, ranging from 0= no pain to 10= unbearable Pain.~A negative value in percent change indicates an improvement in brush-evoked allodynia intensity."|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.|||percentage of change||Standard Deviation|Mean
2841214|NCT00160667|Secondary|Percentage of Subjects With Categorized Change in Post-herpetic Neuralgia Assessed by Investigator's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit|Investigator´s global assessment of change was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.|||percentage of participants|||Number
2841215|NCT00160667|Secondary|Percentage of Subjects With Categorized Change in Pain Assessed by Patient's Global Evaluation Scale at the Evaluation / Early Discontinuation Visit|Patient´s global assessment of change in pain was performed using a seven-point scale (7= Marked improvement, 6= Moderate improvement, 5= Slight improvement, 4= No change, 3= Slight worsening, 2= Moderate worsening, 1= Marked worsening).|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects with valid data at the Evaluation / Early Discontinuation visit are included in the analysis.|||percentage of participants|||Number
2841216|NCT00160667|Secondary|Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Visual Analog Scale (VAS) of the SF-MPQ|Pain burden was rated by the subject using the visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). A negative value in absolute change indicates an improvement in pain burden.|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.|||units on a scale||Standard Deviation|Mean
2841217|NCT00160667|Secondary|Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Present Pain Intensity (PPI) Score of the SF-MPQ|Present pain intensity (PPI) was rated by the subject. The score ranges from 0 (no pain) to 5 (excruciating). A negative value in absolute change indicates an improvement in PPI.|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.|||units on a scale||Standard Deviation|Mean
2841218|NCT00160667|Secondary|Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Affective Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~The affective score ranges from 0 to 12. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.~A negative value in absolute change indicates an improvement."|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.|||units on a scale||Standard Deviation|Mean
2841219|NCT00160667|Secondary|Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Sensory Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~The sensory score ranges from 0 to 33. Change = observation mean at Evaluation / Early Discontinuation visit minus Randomization mean.~A negative value in absolute change indicates an improvement."|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects having values at randomization and at Evaluation (V5) / Early Discontinuation are included.|||units on a scale||Standard Deviation|Mean
2841220|NCT00160667|Secondary|Absolute Change From the Randomization Visit to the Evaluation / Early Discontinuation Visit in the Total Pain Score of the Short-Form McGill Pain Questionnaire (SF-MPQ)|The SF-MPQ has three components: the first one consists of 15 subscales (descriptors: 11 sensory, 4 affective) which are rated on an intensity scale with 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total subscales (descriptors). The SF-MPQ also includes a Present Pain Intensity (PPI) index and a visual analogue scale (VAS). Each of the 15 subscales is rated from 0=none to 3=severe pain. The Total Pain Score of the SF-MPQ is the sum of all 15 ratings and can hence vary from 0 (15*0=0: no pain) to 60 (15*4=60: severe pain). The mean change in total score is reported.|Randomization visit, Evaluation / Early Discontinuation visit (up to Week 4)|Only subjects having values at randomization and at evaluation (V5) / early discontinuation are included.|||units on a scale||Standard Deviation|Mean
2842405|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36||||L||Standard Error|Mean
2841221|NCT00160667|Secondary|Percent Change From the Baseline Period to Each Weekly Mean of the Treatment Period in the Sleep Interference Score|"Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.~A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline."|Baseline, each Evaluation visit (up to Week 4)|ITT set included 50 subjects treated with Placebo, 51 subjects treated with brivaracetam (BRV) 200 mg/day, 51 subjects treated with BRV 400 mg/day. Only subjects with valid data for Sleep Interference Score at the respective visit (week) are included in the analysis. Number of participants analyzed is given separately per visit (week).|||percentage of change||Standard Deviation|Mean
2841222|NCT00160667|Secondary|Percent Change From the Baseline Period to the Last Week of the Treatment Period in the Sleep Interference Score|"Sleep interference was scored on a 11-point numerical sleep interference rating scale, ranging from 0 to 10 where 0 = 'pain does not interfere with sleep', 10 = 'pain completely interferes with sleep'.~A negative value in percent change from Baseline indicates a decrease in average sleep interference score from Baseline."|Baseline, last assessment during the 4-week Treatment Period|Only subjects with valid data for Sleep Interference Score are included in the analysis.|||percentage of change||Standard Deviation|Mean
2841223|NCT00160667|Secondary|Percent Change From the Baseline Period to Each Weekly Mean in the Pain Intensity Score|"Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.~A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline."|Baseline, each Evaluation visit (up to Week 4)|Intention-To-Treat set included 50 subjects treated with Placebo, 51 subjects treated with brivaracetam (BRV) 200 mg/day, 51 subjects treated with BRV 400 mg/day. Only subjects with valid data for pain intensity score at the respective visit (week) are included in the analysis. Number of participants analyzed is given separately per visit (week).|||percentage of change||Standard Deviation|Mean
2841224|NCT00160667|Secondary|Responder Rate in Average Pain Intensity Score at the Last Week of the Treatment Period Compared to the Baseline Period|A responder is defined as a subject with a >= 30 % reduction in average pain intensity score at the Evaluation Week (last week of the Treatment Period) compared to the Baseline Period.|Baseline, last week of the 4-week Treatment Period|Only subjects with valid data for average pain intensity score at Baseline and the last week of the 4-week Treatment Period are included in the analysis.|||percentage of participants|||Number
2841225|NCT00160667|Primary|Percentage Change in Average Pain Intensity Score From Baseline to the Last Week of the 4-week Treatment Period|"Pain intensity was scored on a 11-point numeric pain rating scale, ranging from 0 to 10 where 0= no pain and 10= worst possible pain.~A negative value in percent change from Baseline indicates a decrease in average pain intensity score from Baseline."|Baseline, last week of the 4-week Treatment Period|Only subjects with valid data for average pain intensity score at Baseline and the last week of the 4-week Treatment Period are included in the analysis.|||percentage of change||Standard Deviation|Mean
2841226|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.|||units on a scale||Standard Deviation|Mean
2841227|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.|||units on a scale||Standard Deviation|Mean
2841228|NCT00160641|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.|||percentage of participants|||Number
2841229|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/ hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.|||units on a scale||Standard Deviation|Mean
2841230|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 subjects.|||hours||Standard Deviation|Mean
2841231|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 subjects.|||units on a scale||Standard Deviation|Mean
2841232|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 104 of the open-label study|Of the 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 subjects.|||units on a scale||Standard Deviation|Mean
2841233|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.|||percentage of participants||95% Confidence Interval|Number
2841234|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244|The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.|||percentage of participants||95% Confidence Interval|Number
2841235|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196|The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.|||percentage of participants||95% Confidence Interval|Number
2841236|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148|The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.|||percentage of participants||95% Confidence Interval|Number
2841237|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100|The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.|||percentage of participants||95% Confidence Interval|Number
2841253|NCT00160641|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set|||percentage of participants|||Number
2842406|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30||||L||Standard Error|Mean
2841238|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.|||percentage of participants||95% Confidence Interval|Number
2841239|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.|||percentage of participants||95% Confidence Interval|Number
2841240|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244|The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.|||percentage of participants||95% Confidence Interval|Number
2841241|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196|The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.|||percentage of participants||95% Confidence Interval|Number
2841242|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148|The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.|||percentage of participants||95% Confidence Interval|Number
2841243|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100|The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.|||percentage of participants||95% Confidence Interval|Number
2841244|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.|||percentage of participants||95% Confidence Interval|Number
2841254|NCT00160615|Secondary|Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit|"Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline."|From Baseline up to 54 months|Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Percent change||Inter-Quartile Range|Median
2841245|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.|||percentage of participants||95% Confidence Interval|Number
2841246|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244|The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.|||percentage of participants||95% Confidence Interval|Number
2841247|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196|The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.|||percentage of participants||95% Confidence Interval|Number
2841248|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148|The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.|||percentage of participants||95% Confidence Interval|Number
2841249|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100|The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.|||percentage of participants||95% Confidence Interval|Number
2841250|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.|||percentage of participants||95% Confidence Interval|Number
2841251|NCT00160641|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.~The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)|Safety Set|||percentage of participants|||Number
2841252|NCT00160641|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|"A SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalisation or prolongation of existing hospitalisation~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above~First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set|||percentage of participants|||Number
2841255|NCT00160615|Secondary|Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit|"Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline."|From Baseline up to 54 months|Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Percent change||Inter-Quartile Range|Median
2841256|NCT00160615|Secondary|Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit|"Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline."|From Baseline up to 54 months|Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Percent change||Inter-Quartile Range|Median
2841257|NCT00160615|Secondary|Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit|"Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.~Negative values indicate improvement from Baseline."|From Baseline up to 54 months|Full Analysis set included 151 subjects. Only subjects with valid data for Partial (Type I seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Percent change||Inter-Quartile Range|Median
2841258|NCT00160615|Primary|Partial (Type IC) Seizure Frequency Per Week by Analysis Visit|Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.|From Baseline up to 54 months|Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Number of Seizures (Type IC) per week||Inter-Quartile Range|Median
2841259|NCT00160615|Primary|Partial (Type IB) Seizure Frequency Per Week by Analysis Visit|Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.|From Baseline up to 54 months|Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Number of Seizures (Type IB) per week||Inter-Quartile Range|Median
2841260|NCT00160615|Primary|Partial (Type IA) Seizure Frequency Per Week by Analysis Visit|Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.|From Baseline up to 54 months|Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Number of Seizures (Type IA) per week||Inter-Quartile Range|Median
2841261|NCT00160615|Primary|Partial (Type I) Seizure Frequency Per Week by Analysis Visit|Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.|From Baseline up to 54 months|Full Analysis set included 151 subjects. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.|||Number of Seizures (Type I) per week||Inter-Quartile Range|Median
2841262|NCT00160563|Secondary|Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.||18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.||||||
2841263|NCT00160563|Primary|Time to Onset of Asthma||36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.||||||
2841264|NCT00160524|Secondary|Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258||Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||μg/g stool||95% Confidence Interval|Geometric Mean
2841265|NCT00160524|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||mg/L||95% Confidence Interval|Geometric Mean
2841266|NCT00160524|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)|Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
2841267|NCT00160524|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||μg/mL||95% Confidence Interval|Geometric Mean
2842407|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30||||L||Standard Error|Mean
2841268|NCT00160524|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit|All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
2841269|NCT00160524|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.|||percentage of subjects||95% Confidence Interval|Number
2841270|NCT00160524|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
2841271|NCT00160524|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].|||percentage of subjects|||Number
2841272|NCT00160251|Primary|Percent of Participants Who Achieved Sustained Virologic Response (SVR)|"SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed."|Baseline up to Week 73 [24 weeks after end of treatment (EoT)]|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.|||Percent of participants|||Number
2841273|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73) (up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.|||Participants|||Number
2841274|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.|||Participants|||Number
2841275|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.|||Participants|||Number
2841276|NCT00160251|Secondary|Change in Alanine Aminotransferase (ALT) Levels|Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.|Baseline up to dosing change (> 25 weeks)|Only participants with at least one value for the laboratory test were included.|||Participants|||Number
2841277|NCT00160251|Secondary|Trough Plasma Concentration Level|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.|||ng/mL||Standard Error|Mean
2841646|NCT00153101|Secondary|TRANSCEND. Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841278|NCT00160251|Secondary|Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period|"All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.~The dosing interval of 8 hours is represented as the hr in the unit of measure."|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.|||ng*hr/mL||Standard Error|Mean
2841279|NCT00160251|Secondary|Peak Plasma Concentration of Boceprevir (BOC)|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.|||ng/mL||Standard Error|Mean
2841280|NCT00160251|Secondary|Percent of Participants With Virologic Response Prior to Amendment 2|Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.|Week 3, Week 5, Week 13||||Percent of participants|||Number
2841281|NCT00160251|Secondary|Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop|"For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:~Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).~Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group."|Week 1 and Week 49|N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).|||Percent of participants|||Number
2841282|NCT00160251|Secondary|Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA|Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.|Baseline up to Week 73 [24 weeks after EoT]|Number of participants across all treatment arms who achieved negative HCV-RNA|||Percent of participants|||Number
2841283|NCT00160251|Primary|Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)|"Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed."|Baseline up to Week 49|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.|||Percent of participants|||Number
2841284|NCT00160199|Secondary|Time to Withdrawal Bleeding After Second Treatment Cycle|The number of days between the second cycle of treatment and the withdrawal bleeding|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
2841285|NCT00160199|Secondary|Time to Withdrawal Bleeding After First Treatment Cycle|The number of days between the first cycle of treatment and the withdrawal bleeding.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
2841286|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After Second Treatment Cycle|The numbers of days the subjects actually bled after the end of the second treatment cycle|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
2841287|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After the First Treatment Cycle|The numbers of days the subjects actually bled after the end of the first treatment cycle.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||Days||Standard Deviation|Mean
2841288|NCT00160199|Secondary|Maximum Intensity of Withdrawal Bleeding After Any Cycle|The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy|Duration of withdrawal bleed|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||participants|||Number
2841289|NCT00160199|Primary|Number of Subjects With Withdrawal Bleeding|This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.|After first and second cycle (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||participants|||Number
2841290|NCT00160199|Primary|Secretory Conversion of the Endometrium|Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.|End of the study (Days 85)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.|||participants|||Number
2841647|NCT00153101|Secondary|TRANSCEND. Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841292|NCT00159965|Secondary|Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|"The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a 1 (very good/ no impairment) to 5 (very poor/ severe impairment) scale, and interpersonal relations is rated on a 1 (very good) to 7 (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2841293|NCT00159965|Secondary|Family Assessment Device (FAD)|"The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a 1 to 4 scale, with a higher mean score relating to a worse general functioning."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||General Functioning Subscale Score||Standard Deviation|Mean
2841294|NCT00159965|Secondary|Clinical Global Impressions - Improvement (CGI-I)|"The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved (1) to very much worse (7). A lower score represents a higher improvement."|Weeks 2, 6, 10||||Units on a scale||Standard Deviation|Mean
2841295|NCT00159965|Secondary|Clinical Global Impressions - Severity (CGI-S)|"The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal (1) to among the most extremely ill patients (7). A higher score relates to a higher severity of illness."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2841296|NCT00159965|Secondary|Oxford Handicap Scale (OHS)|"The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from 0 (no symptoms) to 5 (severe handicap). A higher score relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2841297|NCT00159965|Secondary|Symptom Checklist 90 (SCL-90)|"The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from 0 (not at all bothered) to 4 (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2841298|NCT00159965|Secondary|Dissociative Experiences Scale (DES)|"The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% (This never happens to you) to 100% (This always happens to you). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||units on a scale||Standard Deviation|Mean
2841299|NCT00159965|Secondary|Barratt Impulsivity Scale (BIS)|"The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from rarely/ never to almost always with a score of 1 to 4 possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2841300|NCT00159965|Secondary|Davidson Trauma Scale (DTS)|The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||units on a scale||Standard Deviation|Mean
2841301|NCT00159965|Secondary|Global Assessment of Functioning (GAF)|This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||Units on a scale||Standard Deviation|Mean
2841302|NCT00159965|Secondary|Modified Hamilton Depression Scale (MHRS)|"The MHRS assesses the severity of Depression-related symptoms from 0 (not present) to 2, 3 or 4 (severe) on each question. The highest possible score is 72, relating to the worst outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)||||units on a scale||Standard Deviation|Mean
2841303|NCT00159965|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II assesses depression severity from 0 (no Depression-related symptom) to 3 (severe) on each question. The highest possible score is 51, relating to the worst outcome."|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12||||Units on a scale||Standard Deviation|Mean
2841304|NCT00159965|Primary|Number of Nonepileptic Seizures (NES)|psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12||||seizures||Standard Deviation|Median
2841305|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|Per Protocol Population|||percent change||Standard Deviation|Mean
2841306|NCT00159913|Secondary|Change From Baseline to Week 16 in World Health Organization (WHO) Pulmonary Hypertension (PH) Functional Class|WHO PH functional class definitions adapted from New York Heart Association Criteria for Functional Capacity and Therapeutic Class Definitions. Class I = PH without resulting limitation of physical activity, Class II = PH resulting in slight limitation of physical activity, Class III = PH resulting in marked limitation of physical activity, Class IV = PH with inability to carry out any physical activity without symptoms. Improved by 1 class = Class 4 to 3, Class 3 to 2, Class 2 to 1. Improved by 2 classes = Class 4 to 2, Class 3 to 1. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF|||units|||Number
2842095|NCT00147199|Primary|Peak 6-minute Walk Distance|Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation|12 weeks|Intention to treat analysis|||meters||Inter-Quartile Range|Median
2841307|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Psychosocial Scales|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5years with a valid questionnaire available in the subject's first language.|||score on scale||Standard Deviation|Mean
2841308|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5 years with a valid questionnaire available in the subject's first language.|||score on scale||Standard Deviation|Mean
2841309|NCT00159913|Secondary|Change From Baseline to Week 16 in Right Atrial Pressure (RAP)|RAP was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for missing data.|||mm Hg||Standard Deviation|Mean
2841310|NCT00159913|Secondary|Change From Baseline to Week 16 in Cardiac Index (CI)|CI is observed value at Week 16 minus Baseline value. Calculated as cardiac output in systemic circulation (COsys) / body surface area (BSA).|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data.|||liters/minute/meters squared||Standard Deviation|Mean
2841311|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)|Change calculated as (mean PAP - PCWP)/COpulm in PVR is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data|||wood units||Standard Deviation|Mean
2841312|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2)|Time to maximum VO2 was assessed on the subset of subjects who are developmentally able to perform the exercise test. Percent change is [(value at Week 16 minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.|||percent change||Standard Deviation|Mean
2841313|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER)|RER is the ratio of carbon dioxide produced to oxygen consumed [VCO2/VO2]). Percent change is [(Week 16 value minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.|||percent change||Standard Deviation|Mean
2841314|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI)|PVRI equals Pulmonary Vascular Resistance (PVR) times Body Surface Area (BSA). Wood unit = 80dyn•s/cm5. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF|||wood units. m2||Standard Deviation|Mean
2841315|NCT00159913|Secondary|Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP)|mPAP, a hemodynamic parameter, was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using a LOCF (end-of-treatment) approach for handling missing data.|||mm Hg||Standard Deviation|Mean
2841316|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|ITT population included all subjects randomised and who received at least one dose of study medication. All subjects developmentally able to perform the exercise test. Subjects assumed developmentally able if they had a CPX exercise assessment at any visit during study using a LOCF (end-of-treatment)approach for handling missing data.|||percent change||Standard Deviation|Mean
2841317|NCT00159874|Secondary|Physician Global Assessment at Year 1|The physician global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants with markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841318|NCT00159874|Secondary|Participant (Parent) Global Assessment at Year 1|The participant (parent) global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841319|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.|||Units on a scale||Standard Deviation|Mean
2841320|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.|||Units on a scale||Standard Deviation|Mean
2841321|NCT00159874|Secondary|Additions From Baseline in Background Therapy up to the End of Study|This was defined as an addition or discontinuation in the class(es) of drugs used as background medication (e.g., anticoagulants, oxygen, diuretics, calcium channel blockers, and digoxin) compared to baseline of Study A1481131 (NCT00159913).|Up to the end of study|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841322|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 4|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841323|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 (NCT00159913) baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 3|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841324|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 2|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841325|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarized at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.|||Participants|||Number
2841341|NCT00159874|Primary|Discontinuation Due to Intolerability|Participant who experienced drug-related intolerance, the participant's dose was reduced by 50%. If, after a dose reduction, the participant continued to appear intolerant, they were discontinued from study treatment.|Throughout the treatment duration (median treatment duration 1689 to 1744 days)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
2841342|NCT00159874|Primary|Number of Deaths Reported During This Study|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Last follow-up visit or 30 days after the last administration of study drug|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
2841326|NCT00159874|Secondary|Percentage Change From Baseline in Anaerobic Threshold at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the anaerobic threshold at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841327|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal CO2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841328|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal O2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841329|NCT00159874|Secondary|Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the total ventilation. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841330|NCT00159874|Secondary|Percent Change From Baseline in Respiratory Exchange Ratio at Year 1|This is the ratio of carbon dioxide (CO2) produced to O2 consumed [VCO2/VO2]. Exercise Tolerance Test was performed on developmentally able participants to determine the respiratory exchange ratio on week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913).|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841331|NCT00159874|Secondary|Percent Change From Baseline in Time to Maximum VO2 at Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the time to maximum VO2. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841343|NCT00159874|Primary|Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Pre-DMC Recommendation dose down titration (04 August 2011)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
2842096|NCT00147082|Primary|Effective Concentration of MCP-1|Migration response of PBMC to Chemokine|2 hours||||ng/ml||Standard Error|Mean
2841332|NCT00159874|Secondary|Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the percent predicted peak VO2 at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||Percent||Standard Deviation|Mean
2841333|NCT00159874|Secondary|Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX)|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the peak volume of VO2 consumed. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant|1 year|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.|||mL/kg/min||Standard Deviation|Mean
2841334|NCT00159874|Primary|Pediatric Motor Development Status at Week 52|Participant's motor development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
2841335|NCT00159874|Primary|Pediatric Motor Development Status at Week 16.|Participant's motor development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
2841336|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 52.|Participant's cognitive development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
2841337|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 16.|Participant's cognitive development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant's age group is this participant's cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.|||Participants|||Number
2841338|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests.|Colour vision was measured where appropriate via the Farnsworth-Munsell D-15 Hue test. This test was performed in both eyes simultaneously or just in a single specific eye. If using a single eye the same eye was used throughout the study. In case of young participants an age-and-ability-appropriate evaluation such as the Ishihara Test for Unlettered Persons were conducted.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
2841339|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests|Visual Acuity is measured either using the reduced Snellen test or via Teller cards, and was assessed in the left and right eyes separately. There were 9 lines on the reduced Snellen chart which were coded as 6/60, 6/36, 6/24, 6/18, 6/12, 6/9, 6/6, 6/5, 6/4 (where 6/60 was the easiest to read and 6/4 was the most difficult to read). If a participant experienced a visual adverse event the investigator was asked to perform additional ocular assessments either at the visit when the participant reported the visual adverse event or at an unplanned visit.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
2841340|NCT00159874|Primary|Downtitration in Dose Due to Intolerability.|Based on review of the survival data, DMC concluded that the high dose of sildenafil was associated with a harmful effect on survival when compared to the low dose. The DMC also expressed concern as to the potential dose-response relationship between increasing dose and mortality. Therefore, on 04 August 2011, the DMC recommended discontinuation of the 40 mg and 80 mg three times a day (TID) doses, as well as the 20 mg TID dose in children with body weight ≤20 kg. The protocol was amended per DMC recommendations.|Pre-DMC recomendation (04 August 2011)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).|||Participants|||Number
2842408|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24||||L||Standard Error|Mean
2841344|NCT00159874|Primary|Number of Participants Reporting Treatment-related Serious Adverse Events|All serious adverse events regardless of treatment group or suspected relationship to study drug were reported. Investigators were to provide independent determination of possible causality of any serious adverse event.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
2841345|NCT00159874|Primary|Number of Participants Reporting at Least One Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the serious adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
2841346|NCT00159874|Primary|Number of Participants Reporting Treatment-related Adverse Events|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
2841347|NCT00159874|Primary|Number of Participants Reporting at Least One Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).|||Participants|||Number
2841348|NCT00159861|Secondary|Change From Baseline in BORG Dyspnea Score|BORG Dyspnea score: change from core study Baseline. Subject rating of maximum degree of dyspnea experienced at any time during the 6-Minute Walk Test. Range: 0 (no breathlessness at all) to 10 (maximum breathlessness).|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.|||scores on scale||Full Range|Median
2841349|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score|Subject-rated measure of health status (36 items): 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, mental health), 2 summary scores (physical component, mental component), and a self-evaluated change in health status. Change from Baseline in SF-36 Health Transition score at each visit. I=much better than 1 year ago; II=somewhat better than 1 year ago; III=about the same as 1 year ago; IV=somewhat worse than 1 year ago; V=much worse than 1 year ago|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study. BL=Baseline.|||participants|||Number
2841350|NCT00159861|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study.|||scores on scale||95% Confidence Interval|Mean
2841351|NCT00159861|Secondary|Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study.|||scores on scale||95% Confidence Interval|Mean
2841352|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with SF-36 score at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study. Phys = physical.|||scores on scale||95% Confidence Interval|Mean
2841372|NCT00159783|Primary|Concomitant Medications|"Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of~last dose of double-blind study drug."|Up to 40 weeks||||Participants|||Number
2842097|NCT00147082|Primary|Effective Concentration of IL-8|Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro|2 hours||||ng/ml||Standard Error|Mean
2841353|NCT00159861|Secondary|Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class|Pulmonary hypertension (PH) criteria: Class I: PH without limitation of physical activity (PA) (no undue dyspnea, fatigue, chest pain, near syncope); Class II: PH with slight limitation in PA, comfortable at rest, ordinary PA causes undue dyspnea, fatigue, chest pain, near syncope; Class III: PH with marked limitation in PA, comfortable at rest, less than ordinary activity causes undue dyspnea, fatigue, chest pain or syncope; Class IV: PH with inability to carry out PA without symptoms, signs of right heart failure, dyspnea or fatigue may be present at rest, discomfort increased by any PA.|1 Year, 2 Year, 3 Year|FAS; N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects in core study and in extension study. Scores for categorized changes for missing visits imputed as worse score of its non-missing neighbors; missing visits with no subsequent score: score coded to missing.|||participants|||Number
2841354|NCT00159861|Primary|Categorized Change From Baseline in 6-Minute Walking Distance|Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.|1 Year, 2 Year, 3 Year|FAS. m = meters. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.|||participants|||Number
2841355|NCT00159861|Secondary|Survival Status|Yearly survival status: number of subjects who survived, discontinued, and died. Analysis includes post-treatment visit data from subjects who discontinued study treatment. Time to death was taken relative to the first dose of study treatment in A1481141, and was censored on the last day the subject was known to be alive in A1481141 or A1481153.|1, 2, 3, 4, and 5 years|Full analysis set: all randomized and treated subjects recruited into core study. N=number of subjects with evaluable data at core study Baseline.|||participants|||Number
2841356|NCT00159861|Other Pre-specified|Change in Epoprostenol Dose From Baseline Maintained for 6 Months|Number of subjects with changes in Epoprostenol dose from baseline maintained continuously for 6 months. Increased = Epoprostenol dose continuously more than 20% greater than core study Baseline for at least 6 months. Decrease = Epoprostenol dose continuously more than 20% less than core study Baseline for at least 6 months. No change = Epoprostenol dose change met neither Increase or Decrease criteria. Stopped = Epoprostenol dose stopped for at least 6 months.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69|Safety population: all subjects who took at least one dose of study medication in core study. N=number of subjects with evaluable data at core study Baseline. Includes subjects who were only treated in the core study and those who continued into the extension study.|||participants|||Number
2841357|NCT00159822|Secondary|Number of Subjects With Complete or Partial Serological Response|Serological response: normalization (complete response) defined as return to normal values (≤ 1 arc); partial response defined as significant decrease but not complete (decrease of 2 or more arcs compared to baseline). Complete or partial response summarized as Improvement; based on arc values at visit compared to arc values at baseline (inclusion).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT (with serology at inclusion); 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available. Data summarized as Worsening (failure), No change (stabilization), or Improvement (complete or partial response) due to large number of missing results values.|||participants|||Number
2841358|NCT00159822|Secondary|Number of Subjects With Mycological Response of Eradication|Mycological response: eradication: absence of aspergillus species (spp) in bronchopulmonary samples: sputum, bronchial aspirate or bronchoalveolar lavage (BAL) (negative direct examination [exam] and negative culture), and negative histological exam when available; persistence (no eradication): presence of aspergillus spp in any relevant bronchopulmonary samples. Not done (presumed eradication): case reviewed by DRC for any mycological exams not performed to assess if case should constitute presumed eradication (no sputum due to clinical improvement).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available.|||participants|||Number
2841359|NCT00159822|Secondary|Number of Subjects With Complete or Partial Radiological Response|Radiological response: based on chest TDM except for tracheo-bronchialaspergillosis which was assessed by bronchoscopy. Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; End of treatment (EOT) or at last visit available [LVA](EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months).|||participants|||Number
2841360|NCT00159822|Secondary|Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire|Subject administered questionnaire to measure improvement in QOL; 50 questions exploring 3 different areas: symptoms, impact on activity profile (activity), and impact on daily life (impacts). Each item in an area is weighted based on empirical data; scores range from lowest possible weight 0 to highest possible weight 100. Scores for each section and total score calculated using score calculation algorithms with higher scores indicating poor health. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation.|||scores on scale||95% Confidence Interval|Mean
2841361|NCT00159822|Secondary|Global Survival: Number of Subjects With an Outcome of Death|Number of subjects with an outcome of death (adverse event with a fatal outcome) through end of study.|Baseline through EOS (EOT + 6 months)|Safety population (SAF): all subjects who took at least 1 dose of voriconazole.|||participants|||Number
2841428|NCT00158379|Primary|Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%|Time to progression|every 3 months for up to 3 years||||months||95% Confidence Interval|Median
2841362|NCT00159822|Secondary|Time to Relapse After EOT|Time (months) to relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.|||months|||Number
2841363|NCT00159822|Secondary|Number of Subjects With Relapse|Relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.|||participants|||Number
2841364|NCT00159822|Secondary|Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)|Subject assessment of improvement of respiratory clinical signs and symptoms as indicated by the subject placing a mark on a 10 cm VAS scored 0 (better state of health) to 100 (poor state of health) for cough, dyspnea, sputum, hemoptysis, chest tightness, and nocturnal awakening. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation. Subject may be represented in >1 category.|||scores on scale||95% Confidence Interval|Mean
2841365|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT|||paticipants|||Number
2841366|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT|||participants|||Number
2841367|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete (resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline) or partial (reduction in diameter ≥ 50 percent on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion) radiological response and mycological eradication after 3 months of treatment and after 9 or 12 months (in case of extension of treatment period beyond 6 months); no success=criteria not met. Assessment determined by DRC.|Month 3 and End of Treatment (Month 9 or Month 12)|mITT; End of treatment (EOT) or at last visit available [LVA] (EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months). Month 6 analysis is reported in the primary outcome measure.|||participants|||Number
2841368|NCT00159822|Primary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|Modified Intent to Treat (mITT): all subjects in ITT population (took at least 1 dose of voriconazole and had at least 1 post-inclusion efficacy assessment) who had diagnosis of chronic bronchopulmonary aspergillosis confirmed by the Data Review Committee (DRC); 5 subjects excluded from mITT population due to unproven diagnosis.|||participants|||Number
2841369|NCT00159783|Primary|Number of Participants With Laboratory Values Outside Normal Range|"Normal ranges were provided by the central laboratory.~Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin~Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin~Endocrinology/miscellaneous = insulin, prolactin~Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils"|Week 40 or endpoint|"Number at risk = participants with either normal or abnormal baseline value and a non-missing value at endpoint.~Actual at risk: 20-32 for placebo/asenapine arm; 50-78 for asenapine arm; 63-106 in olanzapine arm."|||Participants|||Number
2841370|NCT00159783|Primary|Number of Participants With Markedly Abnormal Vital Sign Changes|"Vital signs measured: sitting blood pressure, heart rate.~Definitions:~Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.~Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg."|Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)||||Participants|||Number
2841371|NCT00159783|Primary|Abdominal Girth|Change in abdominal girth from baseline|Baseline to Week 40 or endpoint||||Centimeters (cm)||Standard Deviation|Mean
2841373|NCT00159783|Primary|Extrapyramidal Symptoms [EPS]|"EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.~AIMS score range 0-4; higher scores indicate greater symptom severity.~BARS score rang 0-9; higher scores indicate greater severity of akathisia.~SARS score range 0-40; higher scores indicate greater degree of Parkinsonism."|Week 40 or endpoint||||Units on a scale||Standard Deviation|Mean
2841374|NCT00159783|Primary|Body Weight|Weight change from baseline|Baseline to Week 40 or endpoint||||Kilograms||Standard Deviation|Mean
2841375|NCT00159783|Primary|Number of Participants With Abnormal Electrocardiogram|This is the number of participants with electrocardiogram (ECG) adverse events.|Week 40 or endpoint||||Participants|||Number
2841376|NCT00159783|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm & rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Week 40 or endpoint||||Participants|||Number
2841377|NCT00159783|Primary|Participants Who Experienced Adverse Event(s)|"Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.~An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.~An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect."|Up to 40 weeks||||Participants|||Number
2841378|NCT00159432|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.|||Participants|||Number
2841379|NCT00159432|Primary|Median Time for Progression Free Survival|Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.|Up to 6 years|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.|||Months||95% Confidence Interval|Median
2841380|NCT00159419|Primary|Bone Mineral Density|"By Dual-energy x-ray absorptiometry. Results were reported as z-scores as well as as absolute values. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome, or similar, as accurate and appropriate."|2 years||||z-score||Standard Deviation|Mean
2841381|NCT00159263|Primary|IL8 mRNA|Measured by PCR|1-2h||||IL8/GNB2L1 ratio||Inter-Quartile Range|Median
2841382|NCT00159263|Primary|Changes in MKP-1 mRNA|Changes in MKP-1 mRNA measured by PCR|1-2h||||MKP1/GNB2L1 ratio||Inter-Quartile Range|Median
2841383|NCT00159263|Primary|Changes in GR-GRE Binding|The GR-GRE binding is the glucocorticoid receptor (GR) DNA binding affinity. GR-GRE activity as assed by enzyme-immunosorbent assay|1-2h|Crossover, each patient had all treatments|||GRE activity (OD)||Inter-Quartile Range|Median
2841384|NCT00159250|Secondary|Number of Participants With Restoration of Dystrophin Protein Expression Measured by Western Blot Analysis||Day 14 to Day 28||||Participants|||Count of Participants
2841385|NCT00159250|Secondary|Number of Participants With Restoration of Dystrophin Protein Expression Measured by Immunocytochemistry||Day 14 to Day 28||||Participants|||Count of Participants
2841386|NCT00159250|Secondary|Number of Participants With Induced Skipping of Exon 51 in the Treated Extensor Digitorum Brevis (EDB) Muscle Determined by Reverse Transcription Polymerase Chain Reaction|Induced Skipping of Exon 51 in the Treated Extensor Digitorum Brevis (EDB) Muscle Determined by Reverse Transcription Polymerase Chain Reaction was assessed by Sequencing of the RT-PCR products|Day 14 to Day 28||||Participants|||Count of Participants
2841387|NCT00159250|Primary|Number of Subjects With Clinically Significant Change From Baseline in Laboratory Values|Assessed by light microscopy and immunocytochemistry to detect the differences in inflammatory infiltrates between the AVI-4568 and placebo-treated EDB muscles|From the Day of Screening up to Day 28||||Participants|||Count of Participants
2841388|NCT00159250|Primary|Number of Participants With Injection Site Reactions||From the Day of Screening to Day 3||||Participants|||Count of Participants
2841389|NCT00159250|Primary|Number of Participants With Adverse Events Related to AVI-4568|Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|Baseline up to Day 120||||Participants|||Count of Participants
2841390|NCT00158925|Secondary|Lead Implant Time|The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.|Implant|Although 96 subjects were implanted/attempted, lead implant time was only collected for 69 subjects.|||h.min||Standard Deviation|Mean
2841391|NCT00158925|Primary|Lead-related Complication-free Rate at 3 Months|The estimated target value for this endpoint is 80%.|3 months||||% of complication free-rate||95% Confidence Interval|Mean
2841392|NCT00158925|Primary|Chronic Sensing Amplitudes at 3 Months|The expected mean is 10mV.|3 months|Although 96 subjects were implanted/attempted, for 67 subjects still in follow up at the end of the 3M fu period, chronic sensing amplitude was measured.|||mV||Standard Deviation|Mean
2841393|NCT00158925|Primary|Chronic Pacing Impedances at 3 Months|The expected mean impedance is 500 Ohms.|3 months|Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu period, the mean impedance was measured.|||Ohms||Standard Deviation|Mean
2841394|NCT00158925|Primary|Chronic Pacing Thresholds at 3 Months|The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.|3 months|Although 96 subjects were implanted/attempted, for 80 subjects still in follow up at the end of the 3M fu periodm the mean pacing threshold was obtained.|||V||Standard Deviation|Mean
2841395|NCT00158860|Secondary|Number of Isolates With Resistance to Acyclovir (ACV)|Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV.|Day 168|ITT population.|||Number of isolates|||Number
2841396|NCT00158860|Secondary|Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months|Diary cards were issued to the participants during randomization visit for recording HSV outbreak within 6-momths. HSV outbreak was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported.|Day 168|ITT population|||Percentage of participants|||Number
2841397|NCT00158860|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant.|Upto Day 168|ITT population|||Participants|||Count of Participants
2841398|NCT00158860|Secondary|Mean Number of GH Recurrences Per Month Within the 6-month Study Period|Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant.|Up to Day 168|ITT population. Only those participants available at the specified time points were analyzed.|||Number of recurrences||Standard Deviation|Mean
2841399|NCT00158860|Primary|Percentage of Participants With Time to First GH Recurrence|Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.|Day 168|ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product.|||Percentage of participants|||Number
2841400|NCT00158756|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 4|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
2841401|NCT00158756|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"Number of subjects with any unsolicited adverse events (AEs)~An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|During the 31-day (Days 0-30) follow-up period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
2841402|NCT00158756|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were diarrhea, drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability, loss of appetite [loss of appet.] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.|During the 8-day period (Days 0-7) post-vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
2841403|NCT00158756|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).|During the 8-Day (Days 0-7) follow-up period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
2841404|NCT00158756|Secondary|Anti-Polio Type 1, 2, 3 Antibody Titers|Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2841405|NCT00158756|Secondary|Concentrations of Anti-RV Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.|At 2.5 months post dose 2 of Rotarix [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.lysis|||U/mL||95% Confidence Interval|Geometric Mean
2841444|NCT00158054|Secondary|Level of Depressive Symptoms|Depressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).|6 months||||units on a scale||95% Confidence Interval|Mean
2841406|NCT00158756|Secondary|Concentrations of Anti-BPT Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2841407|NCT00158756|Secondary|Concentrations of Anti-T Antibodies|Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2841408|NCT00158756|Secondary|Concentrations of Anti-DT Antibodies|Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2841409|NCT00158756|Secondary|Concentrations of Anti-HBs Antibodies|Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2841410|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)|A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841411|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen|A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841412|NCT00158756|Secondary|Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values|A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).|At 2.5 months after dose 2 of Rotarix [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841413|NCT00158756|Secondary|Number of Subjects With Vaccine Response to BPT Antigen|Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841414|NCT00158756|Secondary|Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values|A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841415|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).|At one most post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841416|NCT00158756|Secondary|Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA|A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.|At one month post dose 3 [PIII(M4)]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Subjects|||Number
2841445|NCT00158054|Primary|Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.|Number of participants who rated their depression care as excellent or very good as a percentage.|6 months||||percentage of participants|||Number
2841446|NCT00157950|Secondary|Number of Participants With Adverse Experiences|Number of participants who reported 1 or more adverse experience.|Overall study including 14 calendar days after the last vaccination visit.|All participants who received at least 1 dose of injection.|||Participants|||Number
2841417|NCT00158756|Primary|Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies|Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.|At one month post dose 3 [PIII(M4)]|The analysis were performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2841418|NCT00158743|Primary|Change in Creatinine Clearance|change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab|Baseline to 24-48 hours.||||milliliters/minute||Standard Deviation|Mean
2841419|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax)|Time to maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.|||hours||Standard Deviation|Mean
2841420|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax)|Maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.|||ng/mL||Standard Deviation|Mean
2841421|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 16 hours after the end of infusion. Blood sample time points were 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12 and 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.|||ug*h/mL||Standard Deviation|Mean
2841422|NCT00158600|Secondary|Health-related Quality of Life Survey Values Related to Physical Components as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Scores (PCS) report the four domains of physical functioning, role-physical, bodily pain, and general health. Higher scores are associated with better quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The PCS scores are reported.|weeks 0, 78|ITT population. Last observation carried forward.|||Units on a scale||Standard Deviation|Mean
2841423|NCT00158600|Secondary|Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and is an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|weeks 0, 78|ITT population. Last observation carried forward.|||percent predicted QMT||Standard Deviation|Mean
2841424|NCT00158600|Primary|Percent of Predicted Forced Vital Capacity (FVC)|Forced vital capacity is a standard pulmonary function test used to quantify respiratory muscle weakness. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|weeks 0, 78|ITT population. Last observation carried forward.|||percent predicted FVC||Standard Deviation|Mean
2841425|NCT00158600|Primary|Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline|Mean distance walked gives an indication of functional endurance. The greater the distance, the greater the endurance. Mean values of distance walked in a six-minute walk test are offered for baseline, week 78 (or last available observation), and the mean change from baseline (at week 78 or last available post-baseline observation).|weeks 0, 78|Intent-to-Treat (ITT) population. Last observation carried forward. The last available distance walked for one patient was the Baseline visit; therefore, this patient was excluded from the change from baseline calculation.|||meters||Standard Deviation|Mean
2841426|NCT00158600|Primary|Summary of Patients Reporting Treatment-Emergent Adverse Events|Overall safety summary of patients experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment, i.e., alglucosidase alfa or placebo.|weeks 0-78|"All patients who received any amount of study treatment comprise the safety population. Patients were considered, for safety analysis, to be in the treatment group of the treatment they actually received.~Missing or invalid safety or resource utilization data were not replaced."|||participants|||Number
2841427|NCT00158379|Secondary|Toxicity|defined as hematological and non-hematological adverse events of grade >= grade 1|after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years||||participants|||Number
2842409|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24||||L||Standard Error|Mean
2841429|NCT00158262|Primary|Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven mental imagery of traumatic events (two exemplars) that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD were used to calculate each participant's posterior probability of being classified as PTSD.|Month 3|All randomized participants with data available for analysis at Month 3. Data were missing in 6 placebo and 5 propranolol participants.|||percent probability||Standard Deviation|Mean
2841430|NCT00158262|Secondary|Clinician-Administered PTSD Scale (CAPS) Total Score|The clinician evaluated the overall frequency and intensity/severity of the participant's PTSD symptoms using the CAPS. 17 Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) PTSD symptoms were assessed using a 5-point scale for intensity where 0=none to 4=extreme and a 5-point scale for frequency where 0=never to 4=most or all of the time. The intensity score and the frequency scores were added together for a total possible score of 0 (best) to 136 (worst).|Months 1 and 3|All randomized participants with CAPS data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2841431|NCT00158262|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven mental imagery of traumatic events (two exemplars) that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD were used to calculate each participant's posterior probability of being classified as PTSD.|Month 1|All randomized participants with data available for analysis at Month 1. Data were missing in 2 placebo and 2 propranolol participants.|||percent probability||Standard Deviation|Mean
2841432|NCT00158249|Secondary|Neurocognitive Function|Multiple Source Interference Test (MSIT)|Before and after 8 weeks of treatment||||Accuracy percent improvement||Standard Error|Mean
2841433|NCT00158249|Primary|Marijuana Use||Measured for 8 weeks of treatment||||Reported uses per day||Standard Error|Mean
2841434|NCT00158223|Primary|Negative Syndrome Scale (PANSS) Total Score|Severity of negative schizophrenic symptoms, The Negative Syndrome scale is compromised of seven items, each scored on severity with numeric assignments ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The items which comprise the Negative Syndrome Scale of the PANSS measure things such as emotional withdrawal, apathy, difficulty in abstract thinking, etc. The seven items which comprise the PANSS Negative Subscale has an aggregate range of 7 (absent) to 49 (extreme psychopathology), a higher score indicating more severe symptoms.|Variable change from baseline to week 12||||units on a scale||Standard Deviation|Mean
2841435|NCT00158223|Secondary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression-improvement (CGI-improvement) scale is a research rating tool, developed for use in NIMH-sponsored clinical trials provides a brief assessment of the clinician's view of the patient's overall clinical improvement prior to and after initiating a study medication. The CGI-change is rated on a seven point scale ranging from 1= very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment. Therefore, a lower score indicates more improvement in symptoms over time.|variable change from baseline to week 12||||units on a scale||Standard Deviation|Mean
2841436|NCT00158223|Primary|Positive Syndrome Scale (PANSS) Total Score|Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.|Variable change from baseline to week 12||||units on a scale||Standard Deviation|Mean
2841437|NCT00158197|Primary|Methamphetamine Use, Follow-Up|Drug use measured by urine toxicology conducted by on site EMIT assay over time|1x/month for 4 months||||percentage of negative urine samples|Participants||Number
2841438|NCT00158197|Primary|Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence|Drug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual|16 Weeks||||days||Standard Deviation|Mean
2841439|NCT00158197|Primary|Methamphetamine Use During Intervention|Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.|3x/week for 16 weeks|All individuals randomized were included in the analysis (i.e., intention to treat).|||percentage of negative urine samples|Participants||Number
2841440|NCT00158184|Secondary|Drug Liking|"Subjective rating of drug Liking on a scale of 0 to 100. Greater numbers indicate greater subjective report of Liking."|Highest rating obtained following adminstration of each of the 3 test doses.||||units on a scale||Standard Error|Mean
2841441|NCT00158184|Primary|Breakpoint|"Maximum number of finger presses on a computer mouse completed. The Breakpoint is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability."|Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session||||Mouse Clicks||Standard Error|Mean
2841442|NCT00158054|Secondary|All-cause Mortality|All- cause mortality|18 months||||participants|||Number
2841443|NCT00158054|Secondary|Number of Participants Experiencing Major Adverse Cardiovascular Events|The table represents the number of participants experiencing major adverse cardiovascular events|6 months||||participants|||Number
2841447|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 18.|Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2841448|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 16.|Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2841449|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 11.|Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2841450|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 6.|Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.|||Participants|||Number
2841451|NCT00157820|Secondary|Number of Each of the Components of the CSAE|"The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.~Number of each of the components of CSAE, counts the number of events for each pre-determined level."|17 months||||events|||Number
2841452|NCT00157820|Primary|CSAE-score Rate(Clinical Significant Adverse Events Score Rate)|Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.|17 months|ITT|||score/month|CSAE||Number
2841453|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percent retention||Inter-Quartile Range|Median
2841454|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percent retention||Inter-Quartile Range|Median
2841455|NCT00157755|Other Pre-specified|Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.|||Scores on a scale||Standard Deviation|Mean
2841456|NCT00157755|Other Pre-specified|Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.|||Scores on a scale||Standard Deviation|Mean
2841496|NCT00157157|Secondary|Assessment of Blood Loss During Surgical Procedures|Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records)|Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded|Number of participants who underwent a surgical procedure with blood loss assessments|||Percentage Blood Loss||Full Range|Median
2842410|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18||||L||Standard Error|Mean
2841457|NCT00157755|Other Pre-specified|Change in Symptom Score at 12 Months Compared to Baseline.|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.|||Scores on a scale||Standard Deviation|Mean
2841458|NCT00157755|Other Pre-specified|Percentage of Responders at 12 Months|Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percentage of responders|||Number
2841459|NCT00157755|Secondary|Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.|||Percent reduction in WVF||Full Range|Median
2841460|NCT00157755|Secondary|Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.|||Percent reduction in symptom score||Full Range|Median
2841461|NCT00157755|Primary|Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.|||percent reduction in WVF||Full Range|Median
2841462|NCT00157573|Other Pre-specified|Change From Baseline of Anti-Trag Antibodies||Up to 60 months|This outcome measure was originally posted as a secondary outcome measures but was actually an exploratory endpoint. No data was collected.||||||
2841463|NCT00157573|Secondary|Number of Participants With Adverse Events (Toxicity) Grade 3 or 4|Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported.|Up to 460 days|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.|||Participants|||Count of Participants
2841464|NCT00157573|Secondary|Tumor Response Rate (RR)|RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of > 50% over baseline, confirmed by a higher value 21 days later.|Up to 60 months|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.|||Participants|||Count of Participants
2841465|NCT00157573|Secondary|Median Time to Progression (TTP)|TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of > 50% over Baseline, confirmed by a subsequently higher value at least 21 days later.|Up to 60 months|No analysis was performed. No data was reported for TTP in the clinical chart that was found to be reliable or consistent in the absence of proper computed tomography (CT) surveillance.||||||
2841536|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/mL||Standard Deviation|Mean
2841466|NCT00157573|Primary|Median Time to Treatment Termination (TTT)|TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant.|Up to 460 days|After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual white cell count (WCC) was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis.|||days||Full Range|Median
2841467|NCT00157248|Secondary|Laboratory Analyses|"Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Alanine aminotransferase (ALT): 5-45 [U/L]~Aspartate aminotransferase (AST): 10-40 [U/L]~Bilirubin, total: 0.2-1.0 [mg/dL]"|5 years|All treated patients.|||participants|||Number
2841468|NCT00157248|Primary|Yearly Event Rate for Minor Bleeding|"Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.~Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841469|NCT00157248|Secondary|Severe Adverse Event|Frequency of patients with severe adverse events.|5 years|All treated patients.|||participants|||Number
2841470|NCT00157248|Secondary|Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality|"Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841471|NCT00157248|Primary|Yearly Event Rate for Any Bleeding|Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841472|NCT00157248|Primary|Yearly Event Rate for Major + Minor/Relevant Bleeding|Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841473|NCT00157248|Primary|Yearly Event Rate for Major Bleeding|"Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841474|NCT00157248|Secondary|Yearly Event Rate of Death|Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841475|NCT00157248|Secondary|Yearly Event Rate of Other Major Adverse Cardiac Events|Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841476|NCT00157248|Secondary|Yearly Event Rate of Myocardial Infarction|Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841477|NCT00157248|Secondary|Yearly Event Rate for Systemic Thromboembolism|"Time to first occurrence of any non-central nervous system systemic thromboembolism.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841478|NCT00157248|Secondary|Yearly Event Rate for Transient Ischaemic Attacks|Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841479|NCT00157248|Secondary|Yearly Event Rate of Haemorrhagic Stroke|Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841480|NCT00157248|Secondary|Yearly Event Rate of Ischaemic Stroke|Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841481|NCT00157248|Secondary|Yearly Event Rate for Stroke|Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841482|NCT00157248|Primary|Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.|Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.|||yearly event rate (percentage)|||Number
2841483|NCT00157209|Secondary|Number of Participants With Elevated CA27-29 Antigen Levels|CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.|Study entry, Week 8|"Analysis population included all randomized participants. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."|||participants|||Number
2841484|NCT00157209|Secondary|Number of Participants With Positive T-cell Proliferation|T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.|Time from randomization until cut-off date (15 March 2006)|"Analysis population included all randomized participants. N signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment."|||participants|||Number
2841497|NCT00157157|Secondary|Assessment of Postoperative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale:~Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure~Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure~Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen~None: bleeding from inadequate response with proper dosing, necessitating a change in regimen"|Assessed at the time of discharge from hospital or clinic|Number of participants who underwent a surgical procedure with a postoperative assessment of hemostatic efficacy|||Procedures|||Number
2842098|NCT00147082|Primary|Effective Concentration (EC 50) of GRO Alpha|Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro|2 hours||||ng/ml||Standard Error|Mean
2841485|NCT00157209|Secondary|Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score|"Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL."|At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.|"Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."|||Units on a scale||Standard Deviation|Mean
2841486|NCT00157209|Primary|Overall Survival Time|Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)|Analysis population included all randomized participants.|||months||95% Confidence Interval|Median
2841487|NCT00157209|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.|From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)|Analysis population included all participants randomized in the study.|||participants|||Number
2841488|NCT00157196|Secondary|Progression Free Survival (PFS) Time|PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.|||months||95% Confidence Interval|Median
2841489|NCT00157196|Secondary|Survival Time|Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.|||months||95% Confidence Interval|Median
2841490|NCT00157196|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.|||participants|||Number
2841491|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Number of Participants With Intensive Treatment and High Dose (≤20 Exposure Days (EDs))|Immunogenicity Analysis Set- Participants with 5 consecutive study days of a mean infusion dose of FVIII >50 IU/kg within ≤20 EDs who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM|||Participants|||Number
2841492|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Race|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM|||Participants|||Number
2841493|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM|||Participants|||Number
2841494|NCT00157157|Secondary|Development of Antibodies to Heterologous Proteins|Percentage of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF)|Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit.|Participants who received at least 1 infusion of rAHF-PFM and had assessments of heterologous antibodies|||Percentage of Participants|||Number
2841495|NCT00157157|Secondary|Adverse Events Deemed Related to Treatment|Percentage of participants who reported AEs deemed related to treatment with rAHF-PFM|Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM|||Percentage of Participants|||Number
2841648|NCT00153101|Secondary|TRANSCEND. Non-fatal Myocardial Infarction|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841498|NCT00157157|Secondary|Assessment of Intra-operative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale:~Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals~Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals~Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved~None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen"|Assessed at the time of discharge from recovery room|Number of participants who underwent a surgical procedure with an intraoperative assessment of hemostatic efficacy|||Procedures|||Number
2841499|NCT00157157|Secondary|In Vivo Incremental Recovery|Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.|30 minutes pre-infusion to 30 minutes post-infusion|Participants who received pharmacokinetic rAHF-PFM infusions, did not develop inhibitors, and had assessments|||IU/dL per IU/kg||Full Range|Median
2841500|NCT00157157|Secondary|Weekly rAHF-PFM Utilization|"Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management.~rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on-demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution's standard of care.~rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period|||IU/kg||Full Range|Median
2841501|NCT00157157|Secondary|Annualized Rate of Bleeding Episodes|Number of bleeding episodes per subject annualized over 1 year for all etiologies|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period|||bleeding episodes per subject per year||Full Range|Median
2841502|NCT00157157|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or~None: No improvement or condition worsens."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|"Participants who received at least 1 infusion of rAHF-PFM and had at least 1 treated bleeding episode. The 1 rating of none was for the first 2 infusions, the last infusion was rated as good."|||bleeding episodes|||Number
2841503|NCT00157157|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM for the treatment of bleeding episodes|||Bleeding episodes|||Number
2841504|NCT00157157|Primary|Factor VIII Inhibitor Development|Percentage of treated participants who developed factor VIII inhibitors|Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM|||percentage||95% Confidence Interval|Number
2841505|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
2841506|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
2841507|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||MCAR per patient||Standard Deviation|Mean
2841508|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)|A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
2841509|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)|Severe Acute Rejection was defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
2841510|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.|||Days||Standard Deviation|Mean
2841511|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one rejection episode."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
2841512|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
2841513|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
2841514|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||nM||Standard Deviation|Mean
2841515|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
2841516|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
2841517|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
2841518|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||MCAR per patient||Standard Deviation|Mean
2841519|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment|The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
2841520|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection|Severe Acute Rejection is defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Patients|||Number
2841521|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.|||Days||Standard Deviation|Mean
2842099|NCT00147069|Primary|Number of Matrix Metalloproteases (MMPs) MMP8|MMPs determined using paired antibody quantitative ELISAs|1 year||||ng/ml||Standard Error|Mean
2841522|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one acute rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Rejection Episodes|||Number
2841523|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
2841524|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
2841525|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~IL= Interleukin"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
2841526|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||g/L||Standard Deviation|Mean
2841527|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/mL||Standard Deviation|Mean
2841528|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ug/L||Standard Deviation|Mean
2841529|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~BNP= Brain Natriuretic Peptide"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/L||Standard Deviation|Mean
2841530|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~GSH/GSSG= ratio of reduced to oxidised glutathione"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Ratio||Standard Deviation|Mean
2841531|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||nM||Standard Deviation|Mean
2841532|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~T-bars = thiobarbituric acid reactive substances"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||nmol/mL||Standard Deviation|Mean
2841533|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
2841534|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~hsCRP= high-sensitivity C Reactive Protein"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||mg/L||Standard Deviation|Mean
2841535|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||μmol/L||Standard Deviation|Mean
2841537|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~s-ICAM= soluble-intracellular adhesion molecule"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||ng/mL||Standard Deviation|Mean
2841538|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~MCP-1= monocyte chemoattractant protein-1"|Pre-Transplant and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||pg/mL||Standard Deviation|Mean
2841539|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)|"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
2841540|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies|"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.|||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
2841541|NCT00156936|Primary|Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 3 years|Safety population includes all enrolled subjects who received at least 1 dose of study drug (VIVITROL 380 mg) in this extension study.|||Participants|||Number
2841542|NCT00156923|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).|Up to 3.5 years of monthly treatment|Subjects who received at least 1 injection of study drug were included in the safety analyses|||Participants|||Number
2841543|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Episodes|Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat|||Migraine/Prob Migraine Headache Episodes||Standard Deviation|Mean
2841544|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat|||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
2841545|NCT00156910|Secondary|Change in Frequency of Acute Headache Pain Medication Intakes|Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time.|Baseline, Week 24|Intent to Treat|||Medication Intakes||Standard Deviation|Mean
2841546|NCT00156910|Secondary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache|Baseline, Week 24|Intent to Treat|||Headache Days||Standard Deviation|Mean
2841547|NCT00156910|Primary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat|||Headache Episodes||Standard Deviation|Mean
2841548|NCT00156819|Primary|Treatment Failure|The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.|16 weeks||||participants|||Number
2841562|NCT00156013|Primary|Phase I Maximum Tolerated Dose|Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.|days 1 -28, maximum 6 cycles|Per protocol guidelines for accrual to the cohorts.|||mg/m^2|||Number
2841549|NCT00156715|Secondary|Clinical Symptoms|The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in this analysis. Participants from Site 2 were all admitted to the study directly from the hospital, which could have affected their behavior.|||Units on a scale||Standard Deviation|Mean
2841550|NCT00156715|Primary|Mean Number of Drinking Days Per Week|Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in the analysis. Participants from Site 2 were all admitted to the study directly from the hospital which could have affected their alcohol consumption.|||Drinking Days per Week||Standard Deviation|Mean
2841551|NCT00156533|Secondary|Wake After Sleep Onset (WASO)|Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-Treatment (12 weeks)|Completers|||participants|||Number
2841552|NCT00156533|Primary|Sleep Latency (SL)|Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-treatment (12wks)|Completers Only|||participants|||Number
2841553|NCT00156390|Secondary|Echocardiographic Changes|These parameters compared the echocardiographic measures at baseline prior to device implantations to those obtained 6 to 12 months after device implantation. Data for ESV and EF are presented as percent relative change (standard deviation)|1 year|Echo Results. The numbers in the outcome measure data table represent the patients who had both baseline and follow-up echo data. Patients who died or were lost to follow-up before having their follow-up echocardiogram are not included in this analysis.|||percent change||Standard Deviation|Mean
2841554|NCT00156390|Primary|Minnesota For Living With Heart Failure Questionnaire|"Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = no heart failure did not prevent one from living as they want and 5= yesheart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life."|1 year||||units on a scale||Standard Deviation|Mean
2841555|NCT00156247|Secondary|Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|6 months||||percent|||Number
2841556|NCT00156247|Secondary|Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months||||percent|||Number
2841557|NCT00156247|Primary|Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months||||percent|||Number
2841558|NCT00156065|Primary|Median Survival Time of Effect|"Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension.~PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.~Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|52 Weeks|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.|||Days||95% Confidence Interval|Median
2841559|NCT00156065|Primary|Loss of Effect Over Time|"Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension.~PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.~Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|Throughout the 52 weeks of the trial.|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.|||Participants|||Number
2841560|NCT00156013|Secondary|Toxicity|Number of Participants with Toxicity|5 years||||Participants|||Count of Participants
2841561|NCT00156013|Primary|Phase II Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|5 years||||Participants|||Count of Participants
2841563|NCT00154466|Secondary|Angiogenic Cytokines at Baseline and 3-month Follow-up|Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at −70°C. High-sensitivity ELISA (Bender MedSystems, R&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer's protocols.|3 months|We calculated that we would need 18 patients in each group to achieve a power of at least 80% to detect a 20% difference in MBF change between study groups, with a two-sided significance level of p<0.05, and a 20% increase for the stress MBF change from baseline to 3 months' follow-up. The analysis was intention-to-treat.|||pg/ml||Standard Deviation|Mean
2841564|NCT00154466|Primary|Myocardial Blood Flow at Baseline and 3-month Follow-up|First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.|3 months|Eligible patients were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. Healthy controls underwent the test of myocardial perfusion only at baseline. The analysis was intention-to-treat.|||ml/min/g||Standard Deviation|Mean
2841565|NCT00154375|Secondary|Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations|National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|6 months - 1 year|The safety population consisted of randomized patients with at least one dose of randomized medication.|||Participants|||Number
2841566|NCT00154375|Primary|Percentage of Participants With Progression Free Survival (PFS) During the Study Duration|PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).|6 months -1 year|The ITT population consists of all randomized patients, analyzed according to their randomized treatment.|||Percentage of Participants||95% Confidence Interval|Number
2841567|NCT00154310|Secondary|Number of Participants Who Experienced an Adverse Event or Serious Adverse Event|Additional information about the number of participants who experienced Adverse Events (greater than 5%) or Serious Adverse Events can be found in the Adverse Event section.|Aes from end of core study period (month 12) to end of follow-up period (month 60)|Safety Population consisted of all participants in whom transplantation was performed and who were treated with at least one dose of any immunosuppressive medication.|||Participants|||Number
2841568|NCT00154310|Secondary|Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12|An updated 1991 Framingham coronary prediction algorithm was used to estimate the total risk of developing coronary heart diseases (CHD) over the course of 10 years. Risk was calculated separately for male and females. To calculate risk, points were assigned for each of the following risk factors: age, levels of LDL cholesterol, HDL cholesterol, blood pressure, cigarette smoking, and diabetes mellitus. The sum of the individual risk factor points gives a total point score, which ranges from -5 to 18 for men and -16 to 24 for women. Higher points indicate a higher risk for CHD.|Month 4.5 and Month 12|Safety Population for whom data was available at Month 4.5 and end of treatment.|||Points||Standard Deviation|Mean
2841569|NCT00154310|Secondary|Number of Participants With Occurrence of Treatment Failures|Treatment failures defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity, or conversion to another regimen (at least one condition must be present).|up to or at Month 12|Intention to treat (ITT) population (Randomized Patients).|||Participants|||Number
2841570|NCT00154310|Secondary|Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death|The number of participants with occurrence of biopsy proven acute rejection (BPAR), graft loss, or death up to Month 12 during the randomized treatment period. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III according to Banff 97 classification. A graft core biopsy was performed prior to 24 hours following initiation of graft rejection therapy. The allograft is presumed to be lost on the day the patient starts dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|Up to Month 12|Intent to Treat Population (Randomized Patients)|||Participants|||Number
2841571|NCT00154310|Primary|Renal Function (Nankivell Formula) at Month 12 Post Transplantation.|Renal function at the end of the trial assessed as mean absolute values of the glomerular filtration rate (GFR) calculated by Nankivell formula 12 months after renal transplantation. The Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^2 + C ; where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. Estimated GFR is expressed in mL/min per 1.73m^2.|at Month 12 post transplantation|Intent to Treat Population (randomized patients); Last Observation Carried Forward (LOCF). One patient in|||mL/min /1.73m^2||Standard Deviation|Mean
2841649|NCT00153101|Secondary|TRANSCEND. Cardiovascular Death|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841575|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.|"The primary efficacy variable was the primary failure endpoint at 12 months defined as the occurrence of one or more of the following events within the first 12 months:~delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation~efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)~wound healing disorder related to initial transplant surgery"|at 12 Month post-transplantation|Intention to treat (ITT) population.|||Participants|||Number
2841576|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.|"The primary efficacy variable was the primary failure endpoint at 6 months defined as the occurrence of one or more of the following events within the first 6 months:~delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation~efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)~wound healing disorder related to initial transplant surgery"|at 6 Month post-transplantation|Intention to treat (ITT) population.|||Participants|||Number
2841577|NCT00154297|Primary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months|"In Failure, is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed)."|Month 3|Intention to treat (ITT) population.|||Participants|||Number
2841578|NCT00154284|Secondary|Calculated Creatinine Clearance at 6 Month and 12 Month|"Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:~CrCl[mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|6 month and 12 months|Intention to treat (ITT) population.|||mL/min||Standard Deviation|Mean
2841579|NCT00154284|Secondary|Serum Creatinine at Month 6 and 12|serum creatinine summarized by mean and standard deviation|6 month and 12 months|Intention to treat (ITT) population.|||µmol/L||Standard Deviation|Mean
2841580|NCT00154284|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up|Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.|Month 12|Intention to treat (ITT) population.|||Participants|||Number
2841581|NCT00154284|Primary|Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)|"Nankivell's formula for calculated GFR is shown below:~GFR [mL/min] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min]."|At Month 3 and Month 12|Intention to treat (ITT) population.|||mL/min per 1.73 m^2||Standard Deviation|Mean
2841582|NCT00154102|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|Safety Population|||participants|||Number
2841583|NCT00154102|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population|||scores on a scale||Standard Error|Least Squares Mean
2841584|NCT00154102|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire & were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96|||scores on a scale||Standard Error|Least Squares Mean
2841585|NCT00154102|Secondary|Participants With No Residual Tumor After Metastatic Surgery|Participants with no residual tumor after on-study surgery for metastases|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|ITT population (allocation to treatment groups as randomized and treated)|||Participants|||Number
2841651|NCT00153101|Secondary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841586|NCT00154102|Secondary|Duration of Response - Independent Review Committee (IRC) Assessments|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)|||months||95% Confidence Interval|Median
2841587|NCT00154102|Secondary|Disease Control Rate - Independent Review Committee (IRC) Assessments|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)|||percentage of participants||95% Confidence Interval|Number
2841588|NCT00154102|Secondary|Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009|||percentage of participants||95% Confidence Interval|Number
2841589|NCT00154102|Secondary|Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009|||percentage participants||95% Confidence Interval|Number
2841590|NCT00154102|Secondary|Best Overall Response Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)|||percentage of participants||95% Confidence Interval|Number
2841591|NCT00154102|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
2841592|NCT00154102|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
2841593|NCT00154102|Secondary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|ITT population (allocation to treatment groups as randomized and treated)|||months||95% Confidence Interval|Median
2841594|NCT00154102|Primary|Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
2841595|NCT00154102|Primary|Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009|||months||95% Confidence Interval|Median
2841596|NCT00154102|Primary|Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
2841671|NCT00153101|Secondary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke|56 months|FAS of the ONTARGET trial|||participants|||Number
2841597|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants.|Week 5 to Week 19|ITT Population|||Percentage of Participants|||Number
2841598|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Week 5 to Week 19|ITT Population|||Percentage of Participants|||Number
2841599|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
2841600|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
2841601|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
2841602|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
2841603|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
2841604|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||Days||Standard Deviation|Mean
2841605|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.|||units on a scale||Standard Deviation|Mean
2841606|NCT00154063|Secondary|Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF)|"The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from very much improved with a score of 1 to very much worse with a score of 7. A responder is defined as being very much improved or much improved. The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment)"|Baseline to Week 23|ITT Population|||Participants|||Number
2841607|NCT00154063|Secondary|Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF)|A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error.|Baseline to Week 19|ITT Population|||Days||Standard Error|Mean
2841705|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 12-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
2841608|NCT00154063|Secondary|Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF)|The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error.|Baseline to Week 19|ITT Population|||Days||Standard Error|Mean
2841609|NCT00154063|Primary|Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)|Baseline to Week 19|The efficacy analysis was performed on the Intention to treat (ITT) Population, which was defined as all randomized subjects who received at least 1 dose of double-blind study medication, and had baseline and postbaseline migraine assessments in at least 1 phase.|||Migraine period||Standard Error|Mean
2841610|NCT00154063|Secondary|Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline.|Baseline, Week 11 to Week 19|ITT Population|||Migraine period||Standard Error|Mean
2841611|NCT00154063|Secondary|Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Baseline to Week 19|ITT Population|||Migraine attack||Standard Error|Mean
2841612|NCT00154063|Secondary|Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF)|The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule.|Baseline to Week 19|ITT Population|||Units on a Scale||Standard Error|Mean
2841613|NCT00154063|Secondary|Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF)|The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error.|Baseline to Week 19|ITT Population|||Hours||Standard Error|Mean
2841614|NCT00153985|Secondary|The Incidence of Grade II-IV Acute Graft vs. Host Disease.|Outcome was measured by incidence and severity of acute and chronic GVHD following donor stem cell infusion.|3 years|All patients enrolled.|||participants|||Number
2841615|NCT00153985|Secondary|Solid Organ Toxicity Related to the Conditioning Regimen.|Outcome was measured by the assessment of organ toxicity related to Busulfex, fludarabine and alemtuzumab.|3 years|All patients enrolled.|||participants|||Number
2841616|NCT00153985|Primary|Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy.|Outcome was measured by ANC >500 for three consecutive days prior to day 30 after PBSC infusion, >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion.|3 years|All patients enrolled.|||participants|||Number
2841617|NCT00153920|Secondary|Number of Participants With Treatment-Emergent Neuropathic Pain|Number of participants experiencing any grade treatment-emergent neuropathic pain events based on CTCAEv3 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||participants|||Number
2841618|NCT00153920|Secondary|Number of Participants With Treatment-Emergent Sensory Neuropathy|Number of participants experiencing any grade treatment-emergent sensory neuropathy events based on CTCAEv3 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||participants|||Number
2841650|NCT00153101|Primary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841619|NCT00153920|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.|The analysis population is comprised of eligible and treated participants.|||months||95% Confidence Interval|Median
2841620|NCT00153920|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.|The analysis population is comprised of eligible and treated participants.|||months||95% Confidence Interval|Median
2841621|NCT00153920|Secondary|Very Good Partial Response (VGPR) Rate|Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a >90% decrease in the difference between involved and uninvolved FLC levels.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||proportion of participants||95% Confidence Interval|Number
2841622|NCT00153920|Primary|Objective Response (OR) Rate|Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; <5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.|||proportion of participants||95% Confidence Interval|Number
2841623|NCT00153842|Primary|Bexarotene Oral Capsules Safety at Two Dose Levels (300 mg/m2 and 400 mg/m2) in Combination With Carboplatin and Taxol®.|At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. For the purpose of this protocol, an initial-dose-limiting toxicity (IDLT) is defined as a clinical observation that is, in the judgment of the Investigator, both attributable to the administration of bexarotene and necessitates a reduction in dose, suspension or discontinuation of study drug because of a NCI CTC Grade 3 or 4 level toxicity (with the exception of elevated lipids).|36 months||||participants experiencing IDLT|||Number
2841624|NCT00153816|Secondary|Advanced Colorectal Lesions|Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.|1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and sufficient histology available to ascertain the endpoint.|||percentage of subjects||95% Confidence Interval|Number
2841625|NCT00153816|Primary|Colorectal Adenomas||1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and had sufficient histology available to ascertain the endpoint.|||percentage of subjects||95% Confidence Interval|Number
2841626|NCT00153803|Secondary|Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo|Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.|18 months||||Participants|||Count of Participants
2841627|NCT00153803|Secondary|Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation|Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.|18 months||||Participants|||Count of Participants
2841628|NCT00153803|Secondary|Percent of Participants Surviving 3 Years||36 months||||percentage of participants|||Number
2842411|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18||||L||Standard Error|Mean
2841630|NCT00153803|Primary|Progression Free Survival|Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.|5 years|NA = not available; The data cannot be located/provided due to the PI leaving the institution.|||Months||Full Range|Median
2841631|NCT00153179|Primary|Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo|Insulin sensitivity (M) is measured by using a hyperinsulinaemic-euglycaemic clamp. Insulin sensitivity (M) was calculated as the average glucose infusion rate (mg/kg of body weight per min) over the last 30 min of the clamp. Higher values indicate better outcomes (more insulin sensitive), while lower values indicate more insulin resistance.|baseline, 7 days|The data for this outcome measure was lost when the investigator left the institution, so the measure was not analyzed.||||||
2841632|NCT00153179|Primary|Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome|Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation.|7 days||||Flow mediated dilation||Standard Deviation|Mean
2841633|NCT00153166|Secondary|'M' = Whole Body Insulin Sensitivity|"A hyperinsulinemic-euglycemic clamp was performed prior to and during FDG-PET imaging to measure insulin sensitivity and to standardize metabolic conditions. Subjects were required to fast for 8 hours prior to the study. Patients were given a primed insulin infusion of 2 mU/kg/min. Serum glucose measurements were made at five-minute intervals from an arterialized venous sample achieved by placing the hand in a warming box at 50°C. Blood glucose levels are checked every 5 minutes and 20% dextrose infusion is adjusted to maintain a serum glucose level of approximately 80 mg/dL. Subjects were considered to have achieved steady state when the dextrose infusion rate required to maintain a serum glucose level of 80 mg/dL varied by no greater than 5%. To compute the steady-state glucose disposal rate, we averaged the glucose infusion rates over the last 20 minutes of the clamp and applied a space correction to account for small changes in serum glucose levels over that time period."|every 5 minutes for 20 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.|||mg/kg/min||Inter-Quartile Range|Median
2841634|NCT00153166|Primary|Lower Extremity Skeletal Muscle Glucose Uptake|Net calf skeletal muscle glucose uptake determined by Patlak modeling.|60 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.|||umol/kg/min||Standard Deviation|Mean
2841635|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841636|NCT00153101|Secondary|TRANSCEND. Cardiovascular Revascularization Procedure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841637|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Diabetes|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.|||participants|||Number
2841638|NCT00153101|Secondary|TRANSCEND. Cognitive Decline|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.|||participants|||Number
2841639|NCT00153101|Secondary|TRANSCEND. New Onset of Atrial Fibrillation|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841640|NCT00153101|Secondary|TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841641|NCT00153101|Secondary|TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841642|NCT00153101|Secondary|TRANSCEND. New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial|||participants|||Number
2841652|NCT00153101|Secondary|ONTARGET. New Onset of Atrial Fibrillation|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.|||participants|||Number
2841653|NCT00153101|Secondary|ONTARGET. Cognitive Decline|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.|||participants|||Number
2841654|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Diabetes|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.|||participants|||Number
2841655|NCT00153101|Secondary|ONTARGET. Cardiovascular Revascularization Procedure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).|56 months|FAS of the ONTARGET trial|||participants|||Number
2841656|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841657|NCT00153101|Secondary|ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841658|NCT00153101|Secondary|ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria|ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria|56 months|FAS of the ONTARGET trial|||participants|||Number
2841659|NCT00153101|Secondary|ONTARGET. New Macroalbuminuria|ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841660|NCT00153101|Secondary|ONTARGET. New Microalbuminuria|ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841661|NCT00153101|Primary|ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients|"ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.~These renal outcomes were not adjudicated (apart from death)."|56 months|Subset of the Full Analysis Set (FAS [DN]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial.|||participants|||Number
2841662|NCT00153101|Secondary|ONTARGET. Progression to ESRD|ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m².|56 months|FAS of the ONTARGET trial|||participants|||Number
2841663|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine|ONTARGET. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the ONTARGET trial|||participants|||Number
2841664|NCT00153101|Secondary|ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial|||participants|||Number
2841665|NCT00153101|Secondary|ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients|ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial|||participants|||Number
2841666|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial|||participants|||Number
2841667|NCT00153101|Secondary|ONTARGET. Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841668|NCT00153101|Secondary|ONTARGET. Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841669|NCT00153101|Secondary|ONTARGET. Non-fatal Myocardial Infarction|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841670|NCT00153101|Secondary|ONTARGET. Cardiovascular Death|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841672|NCT00153101|Primary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial|||participants|||Number
2841673|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)||time since randomization; follow-up period is 1.5 to 4.4 years||||Participants|||Number
2841674|NCT00153062|Secondary|Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)||Randomization to final patient contact|Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
2841675|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)|Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
2841676|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)|Number of patients with any of stroke, myocardial infarction, vascular death|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
2841677|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)||time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.|||Participants|||Number
2841678|NCT00152971|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 12-15 days|Treated set|||Participants|||Number
2841679|NCT00152971|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up|||Participants|||Number
2841680|NCT00152971|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op|||Participants|||Number
2841681|NCT00152971|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op|||Participants|||Number
2841682|NCT00152971|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op (all patients who are treated and operated)|||Participants|||Number
2841683|NCT00152971|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
2841684|NCT00152971|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)|||Participants|||Number
2841685|NCT00152971|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)|||Participants|||Number
2841706|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at Baseline|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Baseline|Intention to treat analysis although data for participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2842100|NCT00147069|Primary|Number of Matrix Metalloproteases (MMPs) MMP3|MMPs determined using paired antibody quantitative ELISAs|1 year||||ng/ml||Standard Error|Mean
2841686|NCT00152971|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 12-15 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)|||Participants|||Number
2841687|NCT00152763|Secondary|Percentage of Participants Who Received ICD Therapies|Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.|12-months follow-up||||Percentage of participants|||Number
2841688|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 12-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
2841689|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 6-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
2841690|NCT00152763|Secondary|SF-36 Physical Component Summary Score at Baseline|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Baseline||||units on a scale||Standard Deviation|Mean
2841691|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
2841692|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
2841693|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
2841694|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
2841695|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
2841696|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at Baseline|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
2841697|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Twelve-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis|||units on a scale||Standard Deviation|Mean
2841698|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Six-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis|||units on a scale||Standard Deviation|Mean
2841699|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at Baseline|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Baseline|Intention to treat analysis although data from participants who died were omitted from analysis|||units on a scale||Standard Deviation|Mean
2841700|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Twelve-months follow-up||||units on a scale||Standard Deviation|Mean
2841701|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
2841702|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at Baseline|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
2841703|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 12-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Twelve-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841704|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 6-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Six-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841707|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841708|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841709|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841710|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841711|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 6-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Six-months follow-up||||units on a scale||Standard Deviation|Mean
2841712|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841713|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at Baseline|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Baseline||||units on a scale||Standard Deviation|Mean
2841714|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at Baseline|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.|||units on a scale||Standard Deviation|Mean
2841715|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.|||Number of subjects|||Number
2841716|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.|Visit 5 (week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.|||Number of subjects|||Number
2841717|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.|||Number of subjects|||Number
2841718|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.|Visit 5 (Week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.|||Number of subjects|||Number
2842101|NCT00147069|Primary|Number of Matrix Metalloproteases (MMPs) MMP1|MMPs determined using paired antibody quantitative ELISAs|1 year||||ng/ml||Standard Error|Mean
2842412|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12||||L||Standard Error|Mean
2841719|NCT00152516|Secondary|Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)|The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.|Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)|At baseline there were 98 subjects with valid Memory Screen composite scores (mean=85.5, standard deviation=18.7). Of these 98 subjects, 87 had valid scores at Visit 5 (week 24) and 80 at Visit 7 (week 48).|||Score on a scale||Standard Deviation|Mean
2841720|NCT00152516|Secondary|Subject (>=8 Years Old) Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects >= 8 years old for whom the assessment was performed|||Percentage of Participants|||Number
2841721|NCT00152516|Secondary|Parent/Guardian Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed|||Percentage of Participants|||Number
2841722|NCT00152516|Secondary|Investigator Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed|||Percentage of Participants|||Number
2841723|NCT00152516|Secondary|Percent of Subjects With Each Seizure Type During the Evaluation Period|"Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).~Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).~Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).~A subject could experience more than one seizure type."|Evaluation period (48 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data.|||Percentage of Participants|||Number
2841724|NCT00152516|Secondary|Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period|"The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.~The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks."|greater than or equal to 24 weeks, greater than or equal to 40 weeks|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.|||Percentage of Participants|||Number
2841725|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) subjects with > 24 weeks of exposure and treatment period seizure data|||Percentage of Days||Inter-Quartile Range|Median
2841726|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) Subjects with <= 24 Weeks of Exposure and treatment period seizure data|||Percentage of Days||Inter-Quartile Range|Median
2841727|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) Subjects with > 24 Weeks of Exposure and treatment period seizure data|||Percentage of days||Inter-Quartile Range|Median
2841728|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) subjects with <= 24 Weeks of Exposure and treatment period seizure data|||Percentage of Days||Inter-Quartile Range|Median
2841729|NCT00152516|Secondary|Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase|"The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.~Note: Rates were reported as percentages."|Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.|||Percentage of Participants|||Number
2841743|NCT00152464|Secondary|Percentage of Days With Symptoms of Wheezing|The caring person was to note on the diary card each each wheezing event occurring at any time.|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||percentage of days||Standard Deviation|Mean
2842413|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12||||L||Standard Error|Mean
2841730|NCT00152516|Secondary|Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
2841731|NCT00152516|Secondary|Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
2841732|NCT00152516|Secondary|Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
2841733|NCT00152516|Secondary|Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.|||Seizures Per Week||Inter-Quartile Range|Median
2841734|NCT00152516|Secondary|Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 2 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 248. Of these 248 subjects 227 continued into the maintenance period.|||Percent Reduction in Seizures per Week||Inter-Quartile Range|Median
2841735|NCT00152516|Primary|Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.|||percent reduction in seizures Per Week||Inter-Quartile Range|Median
2841736|NCT00152464|Secondary|Number of Episodes of Urticaria Per Subject|Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger.|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||Number of episodes||Standard Deviation|Mean
2841737|NCT00152464|Secondary|Percentage of Subjects With Urticaria|Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger.|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||percentage of participants|||Number
2841738|NCT00152464|Secondary|Percentage of Days of Use of Medication for Atopic Dermatitis|The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non‐steroidal anti‐inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics|During the treatment period (18 months)|255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category.|||percentage of days||Standard Deviation|Mean
2841739|NCT00152464|Secondary|Percentage of Subjects Using Medication for Atopic Dermatitis|The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non‐steroidal anti‐inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||percentage of subjects|||Number
2841740|NCT00152464|Secondary|Percentage of Days of Use of Asthma Medication|The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists|During the treatment period (18 months)|255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category.|||percentage of days||Standard Deviation|Mean
2841741|NCT00152464|Secondary|Percentage of Subjects Using Asthma Medication|The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||percentage of participants|||Number
2841742|NCT00152464|Secondary|Percentage of Days With Symptoms of Nocturnal Cough|The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||percentage of days||Standard Deviation|Mean
2841744|NCT00152464|Secondary|Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough|The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms.|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||percentage of days||Standard Deviation|Mean
2841745|NCT00152464|Primary|Time to Onset of Asthma During the Treatment Period|"The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma.~Instead of the median the first Quartile is reported since the median (50%) was not reached."|During the treatment period (18 months)|Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.|||months||95% Confidence Interval|Median
2841746|NCT00152009|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 5 weeks|ITT|||Units on a scale||Standard Error|Least Squares Mean
2841747|NCT00152009|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT|||Participants|||Number
2841748|NCT00152009|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT|||Participants|||Number
2841749|NCT00152009|Secondary|Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks|The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT|||Units on a Scale||Standard Error|Least Squares Mean
2841750|NCT00152009|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT|||Units on a Scale||Standard Error|Least Squares Mean
2841751|NCT00152009|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 5 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the baseline and at least one post-randomization primary efficacy measurement.|||Units on a Scale||Standard Error|Least Squares Mean
2841752|NCT00151996|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100 for each. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2841753|NCT00151996|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Participants|||Number
2841754|NCT00151996|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks|The Conner's Parent Rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|FAS|||Units on a Scale||Standard Deviation|Mean
2841755|NCT00151996|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Participants|||Number
2841756|NCT00151996|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects with a baseline and at least one post-baseline efficacy measurement.|||Units on a Scale||Standard Deviation|Mean
2841757|NCT00151892|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score|Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.|6 Months|Intent to treat (ITT) population defined as all randomized subjects who received at least 1 dose of investigational product. Analysis includes patients who completed an SIBDQ questionnaire at 6 months.|||Units on a scale||Standard Deviation|Mean
2842414|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6||Month 6||||L||Standard Deviation|Mean
2841758|NCT00151892|Secondary|Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months|The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.|Baseline and 6 months|PP|||Units on a scale||Standard Deviation|Mean
2841759|NCT00151892|Secondary|Endoscopic Remission of UC With No or Mild Symptoms at 6 Months|Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|6 Months|PP|||percent of participants|||Number
2841760|NCT00151892|Secondary|Withdrawal Due to Relapse of UC|Relapse is defined as withdrawal from the study due to lack of efficacy.|Over 6 Months|PP|||percent of participants|||Number
2841761|NCT00151892|Primary|Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|6 Months|Per Protocol Population (PP) defined as all subjects who either completed the study or withdrew for reasons related to efficacy or AEs and who were deemed to be protocol-compliant.|||percent of participants|||Number
2841762|NCT00151814|Primary|For Olmesartan, the Apparent Oral Volume of Distribution||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||L||Standard Deviation|Mean
2841763|NCT00151814|Primary|For Olmesartan, the Apparent Oral Clearance||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||L/hr||Standard Deviation|Mean
2841764|NCT00151814|Primary|For Olmesartan, the Elimination Half-life of the Drug in Plasma||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||hr||Standard Deviation|Mean
2841765|NCT00151814|Primary|Foe Olmesartan, the Time of Maximum Plasma Concentration||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||hr||Standard Deviation|Mean
2841766|NCT00151814|Primary|For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||ng/mL||Standard Deviation|Mean
2841767|NCT00151814|Primary|For Olmesartan, the Elimination Constant Rate||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||L/hr||Standard Deviation|Mean
2841768|NCT00151814|Primary|For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||ng/mL*hr||Standard Deviation|Mean
2841769|NCT00151814|Primary|For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.|||ng/mL*hr||Standard Deviation|Mean
2841770|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.|Day 0 to week 51 week (end of study)|57=the number of participants who received medication in Period 4|||mm Hg||Standard Deviation|Mean
2841771|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 to week 51 (end of study)|Intent to treat population includes participants with at least one visit in Period 4.|||mm Hg||Standard Deviation|Mean
2841772|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.|||mm Hg||Standard Deviation|Mean
2841773|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.|||mm Hg||Standard Deviation|Mean
2841842|NCT00150345|Secondary|Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned||Day 28|MITT; data not summarized as planned; data insufficient for analysis due to missing data.|||participants|||Number
2841774|NCT00151775|Primary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)|Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 (baseline) to 3 weeks|The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used|||mm Hg||Standard Deviation|Mean
2841775|NCT00151775|Primary|Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)|The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.|Day 0 to 3 weeks|The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.|||mm Hg||Standard Error|Least Squares Mean
2841776|NCT00151476|Secondary|Rectal or Pouch Adenoma Burden Based on Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).|Baseline, 6 to 14 months post-baseline, EOS|All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.|||particpants|||Number
2841777|NCT00151476|Secondary|Duodenal Adenoma Burden as Measured by Spigelman Stage|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing.|||participants|||Number
2841778|NCT00151476|Post-Hoc|Duodenal Adenoma Burden as Measured by Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.|||participants|||Number
2841779|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).|||months||Full Range|Median
2841780|NCT00151476|Secondary|Time From Post IRA to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).|||months||Full Range|Median
2841781|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.|||months||Full Range|Median
2841782|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Up to 15 years prior to baseline|All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).|||months||Full Range|Median
2841783|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype [with no prior FAP-related surgery], and start of study follow-up).|||months||Standard Deviation|Mean
2841784|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.|||months||Standard Deviation|Mean
2841785|NCT00151476|Primary|Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).|||months||Standard Deviation|Mean
2841786|NCT00151476|Primary|Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.|Up to 15 years prior to baseline|All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).|||months||Standard Deviation|Mean
2841787|NCT00151476|Primary|Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).|||months||Full Range|Median
2841788|NCT00151476|Primary|Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.|Up to 8 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.|||months||Standard Deviation|Mean
2841789|NCT00151411|Secondary|Change in Insulin Sensitivity Index After 6 Months of Treatment||baseline and 6 months||||index||95% Confidence Interval|Least Squares Mean
2841790|NCT00151411|Secondary|Ovulation Rate|Count of ovulations per subject during the treatment period.|6 months|A total of 76 patients with daily urine collections.|||Participants|||Count of Participants
2841791|NCT00151411|Primary|Change in Testosterone After 6 Months of Treatment||baseline and 6 months||||ng/dL||95% Confidence Interval|Least Squares Mean
2841792|NCT00151372|Secondary|Hamilton Depression Rating Scale|The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."|||points on a scale||Standard Deviation|Mean
2841793|NCT00151372|Primary|Composite Antidepressant Score Scale (CAD)|The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."|||Participants|||Number
2841794|NCT00151320|Primary|ORR|Overall Response Rate|6 cycles (18 weeks)||||percentage of patients|||Number
2841795|NCT00151281|Secondary|The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment|"QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.~ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below."|baseline, every 2 months until Month 6, and every 6 months until disease progression||||FACT-G score||Full Range|Mean
2841796|NCT00151281|Secondary|Dynamic Levels of Plasma VEGF|Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1.|38 months|subjects with evaluable VEGF level at baseline|||pg/mL||Full Range|Median
2841797|NCT00151281|Secondary|Asses the Toxicity Profiles|Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.|38 months|patients treated with study drug|||Participants|||Count of Participants
2841798|NCT00151281|Primary|Overall Survival and Progression Free Survival|measured by overall Response Rate (ORR), which includes Complete response and partial response.|38 months|Twenty-five patients were enrolled, and 22 of those patients were assessable for response (3 patients were enrolled but received no therapy)|||percentage of patients|||Number
2841799|NCT00150969|Secondary|Difference in Number of New Clinical Fractures by Treatment Arm.|these included fragility fractures|up to 48 months||||events|||Number
2841800|NCT00150969|Secondary|Difference in Number of New Cancers by Treatment Arm.||up to 48 months||||events|||Number
2841801|NCT00150969|Secondary|Difference in Serious Adverse Events|These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.|up to 48 months||||events|||Number
2841802|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
2841803|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
2841804|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
2841805|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
2841806|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months||||percentage change in BMD||Standard Deviation|Mean
2841807|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin|measured by osteocalcin hydroxyapatite binding assay|0 to 24 months||||percentage of undercarboxylated OC||Standard Deviation|Mean
2841808|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)|measured by CTX Elisa assay on elecsys platform|0-24 months||||ng/ml||Standard Deviation|Mean
2841809|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker|measured by osteocalcin on elecsys platform|0-24 months||||ng/ml||Standard Deviation|Mean
2841810|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
2841811|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
2841812|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.|||percentage change in BMD||Standard Deviation|Mean
2841813|NCT00150813|Primary|Percentage Participants With Treatment Emergent Adverse Events|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks|Safety Set|||percentage of participants|||Number
2841814|NCT00150800|Secondary|Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period|A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.|From Baseline of the previous study to the Evaluation Period (up to 11 years)|The Partial Onset Seizures (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.|||percentage of participants|||Number
2841815|NCT00150800|Secondary|Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period|"The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:~(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines."|From Baseline of the previous study to the Evaluation Period (up to 11 years)|The Partial Onset Seizures (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.|||percent change||Inter-Quartile Range|Median
2841816|NCT00150800|Secondary|Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period|"Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].~A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28."|From Baseline of the previous study to the Evaluation Period (up to 11 years)|The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.|||Seizures per 28 days||Inter-Quartile Range|Median
2841843|NCT00150345|Secondary|Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned||Day 28|MITT|||participants|||Number
2841817|NCT00150800|Primary|Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period|A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.|Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
2841818|NCT00150800|Primary|Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period|Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.|Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
2841819|NCT00150800|Primary|Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period|Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.|Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
2841820|NCT00150618|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
2841821|NCT00150618|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT|||Participants|||Number
2841822|NCT00150618|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT|||Participants|||Number
2841823|NCT00150618|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|ITT|||Units on a Scale||Standard Error|Least Squares Mean
2841824|NCT00150618|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement.|||Units on a Scale||Standard Error|Least Squares Mean
2841825|NCT00150592|Secondary|Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks|The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.|Baseline and 6 weeks|FAS|||Units on a Scale||Standard Deviation|Mean
2841826|NCT00150592|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and 6 weeks|FAS|||Units on a Scale||Standard Deviation|Mean
2841827|NCT00150592|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Participants|||Number
2841828|NCT00150592|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who received at least one dose of investigational product.|||Units on a Scale||Standard Deviation|Mean
2841829|NCT00150592|Secondary|Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks|"The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue tokens in various displayed boxes and use the tokens to fill a column on the right side of the screen. Subjects can only find tokens in new boxes, therefore they must remember where previous tokens were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance."|Baseline and 6 weeks|PP|||Units on a scale||Standard Deviation|Mean
2841830|NCT00150592|Secondary|Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP|||Units on a scale||Standard Deviation|Mean
2841831|NCT00150592|Secondary|Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP|||Units on a scale||Standard Deviation|Mean
2841832|NCT00150592|Primary|Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks|Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.|Baseline and 6 weeks|Per protocol (PP) defined as all subjects who completed the study and were deemed to be protocol-compliant.|||msec||Standard Deviation|Mean
2841833|NCT00150462|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||ng*minute/mL||Standard Deviation|Mean
2841834|NCT00150462|Primary|Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||ng*minute/mL||Standard Deviation|Mean
2841835|NCT00150462|Primary|Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||minutes||Standard Deviation|Mean
2841836|NCT00150462|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population|||days||Full Range|Median
2841837|NCT00150462|Secondary|Time to Progression|"Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.~Median time to progression was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population|||days||Full Range|Median
2841838|NCT00150462|Secondary|Duration of Response|"Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.~Median duration of response was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable participants with an objective response|||days||Full Range|Median
2841839|NCT00150462|Secondary|Best Clinical Response to Treatment|"Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows:~Complete response: total resolution of measurable disease parameters.~Partial response: a ≥ 50% resolution without the appearance of new disease.~Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.~Progressive disease: an increase of > 25% in measurable disease parameters.~Best clinical response is the best response observed from the start of study treatment until disease progression or death."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.|||participants|||Number
2841840|NCT00150462|Primary|Maximum Observed Plasma Concentration of Carfilzomib (Cmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.|||ng/mL||Standard Deviation|Mean
2841841|NCT00150462|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"A DLT was defined as any of the following occurring in the first 28 days of study participation:~Nonhematologic:~> Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support~Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)~Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.~Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0."|28 days|Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib|||participants|||Number
2841844|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Died). A participant must have died before Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR: no participants met this criteria within the category Died."|||percent of positive PCR assessments|||Number
2841845|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Alive). A participant must be evaluable until Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR. N=number of participants for category Alive."|||percent of positive PCR assessments||Standard Deviation|Mean
2841846|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841847|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841848|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence|Percent of positive panfungal PCR assessments during treatment phase of study in association with time to defervescence. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with time to defervescence was not summarized as planned.|||percent of positive PCR assessments||Standard Deviation|Mean
2841849|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
2841850|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
2841851|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 5 (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 5 (96 hours through 120 hours after start of study treatment)|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841852|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28|Percent of positive panfungal PCR assessments during treatment phase of study in association with proven or probable IFI (complete cases) between Day 2 and Day 28 (Yes or No). Complete case analysis: participant must be evaluable until Day 28 (final visit) or have developed a proven or probable IFI by the final visit. Participant considered evaluable until Day 28 if participant completed the study and completed an assessment of IFI at Day 28 or final visit. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841853|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
2842102|NCT00147069|Primary|Total Number of Inflammatory Cells Recovered in Sputum|Sputum was induced via inhalation of hypertonic saline as previously described, and was processed for differential counts of inflammatory cells.|1 year||||10^6 cells/ml||Standard Error|Mean
2841854|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841855|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)|Percent of positive panfungal PCR assessments during treatment phase of study in association with c-reactive protein level (measured in milligrams per liter [mg/L]) >1.25 x ULN (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with c-reactive protein level was not summarized as planned.|||percent of positive PCR assessments||Standard Deviation|Mean
2841856|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL|Percent of positive panfungal PCR assessments during treatment phase of study in association with neutrophil count >500 uL (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841857|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole|Percent positive panfungal PCR assessments during treatment phase of study in association with use of concomitant (prophylaxis) fluconazole (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841858|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants|Percent of positive panfungal PCR assessments during treatment phase of study in association with allogeneic bone marrow transplant or allogeneic peripheral stem cell transplant (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841859|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease|Percent of positive panfungal PCR assessments during treatment phase of study in association with primary underlying neoplastic disease. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841860|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender|Percent of positive panfungal PCR assessments during treatment phase of study in association with gender (Female or Male). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.|||percent of positive PCR assessments||Standard Deviation|Mean
2841861|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age|Percent of positive panfungal PCR assessments during treatment phase of study in association with age for participants who completed the study and have a non-missing value for percent of positive panfungal PCR.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with age was not summarized as planned.|||percent of positive PCR assessments||Standard Deviation|Mean
2841862|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=No). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
2841863|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=Yes). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.|||percent of positive PCR assessments||Standard Deviation|Mean
2841876|NCT00149890|Secondary|Number of Participants With Bacterial, Viral and Fungal Infections During Six Months|To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.|6 months|Safety Population|||Participants|||Number
2841864|NCT00150345|Secondary|Time to Negative Panfungal Polymerase Chain Reaction (PCR)|Time (in days) from start of study medication to negative panfungal PCR; assessed for participants whose most recent panfungal PCR result prior to start of study medication was positive. Defined as negative if at least 2 successive and all following panfungal PCR assessments from start of study medication until 24 hours after end of treatment are negative. Measured as first quartile of time (point in time measurement; no median or measure of dispersion calculated); median time was not estimable for deferred voriconazole treatment group.|Day 2 through Day 28|MITT; N=number of participants whose most recent panfungal PCR result prior to start of study medication was positive.|||days|||Number
2841865|NCT00150345|Secondary|Number of Participants That Died on or Before Day 28 (Mortality)|Number of participants that died on or before Day 28 after start of study treatment. A participant must be evaluable until Day 28 (final visit) or have died before the final visit.|Day 2 through Day 28|MITT; N=number of participants evaluable until Day 28 (final visit) or died before the final visit.|||participants|||Number
2841866|NCT00150345|Secondary|Number of Participants Per Reason for Lack of Defervescence||Day 2 through Day 28|MITT|||participants|||Number
2841867|NCT00150345|Secondary|Time to Continuous Defervescence|Time (in days) from start of study medication to continuous defervescence. Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours.|Day 2 through Day 28|MITT|||days||95% Confidence Interval|Median
2841868|NCT00150345|Secondary|Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participant's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 9 (192 hours through 216 hours after start of study treatment)|MITT|||particpants|||Number
2841869|NCT00150345|Secondary|Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participants's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 5 (96 hours through 120 hours after start of study treatment)|MITT|||participants|||Number
2841870|NCT00150345|Primary|Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis|Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.|Day 2 through Day 28|Modified Intent-to-Treat population (MITT): participants in ITT population (at least 1 dose of study treatment) with valid post-baseline proven or probable IFI, did not have fungemia or other IFI at screening or randomization, no antipyretic analgesics on Day 5 (or Day 9 of open-label voriconazole). N=number of complete case evaluable participants.|||participants|||Number
2841871|NCT00150176|Secondary|Time to Early Discontinuation for Any Reason|The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).|time of discontinuation up to Day 182 (double blind phase)|Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial.|||participants|||Number
2841872|NCT00150176|Primary|Time to Relapse or an Impending Relapse|"A relapse or impending relapse was declared if a subject meets 1 of 3 symptomatic relapse criteria which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary."|time of first relapse up to Day 182 (double blind phase)|ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed & subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing >3 days after last dose also excluded.|||relapses|||Number
2841873|NCT00149994|Primary|Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.|A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months.|Month 3|Intention to treat (ITT) population.|||Percentage of Participants|||Number
2841874|NCT00149890|Secondary|Percentage of Participants With Treatment Failure Within Three and Six Months|To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.|3 and 6 months|Intention to treat population|||Percentage of participants||95% Confidence Interval|Number
2841875|NCT00149890|Secondary|Time of Onset of a First Biopsy Proven Acute Rejection|"Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension~."|6 months|safety/Intent to Treat (ITT) population|||Months||95% Confidence Interval|Median
2841877|NCT00149890|Secondary|Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation|Graft loss is defined as being listed for a re-transplantation.|3 months and 6 months|safety/Intent to Treat (ITT) population|||Percentage of participants|||Number
2841878|NCT00149890|Secondary|Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months|To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.|3 and 6 months|safety/Intent to Treat (ITT) population|||Participants|||Number
2841879|NCT00149890|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months|At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.|3 months|safety/Intent to Treat (ITT) population|||Participants|||Number
2841880|NCT00149890|Primary|Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation|Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.|3 months after treatment|safety/Intent to Treat (ITT) population|||Participants|||Number
2841881|NCT00149838|Primary|Depression Remission, as Measured by the Hamilton Rating Scale for Depression|The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8|Measured at the end of Phases 1, 2, and 3|Remission|||number of remitted patients|||Number
2841882|NCT00149825|Secondary|Remission of Insomnia|Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.|After 12 weeks or at the last available time point|Included in the analysis were all participants who attended at least one post randomization visit.|||percent|||Number
2841883|NCT00149825|Primary|Remission of Depression (%)|"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.~The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.~The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)."|After 12 weeks or at the last available time point||||percent of participants|||Number
2841884|NCT00149799|Secondary|Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)|Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.|Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)|28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.|||Percentage score||Standard Deviation|Mean
2841885|NCT00149799|Secondary|Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)|Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.|Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)|28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.|||units on a scale||Standard Deviation|Mean
2841886|NCT00149799|Secondary|Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)|Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.|Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40|A total of 58 participants who had responded to open-label Escitalopram (phase 1) were randomized to receive either Escitalopram (n=28) or placebo (n=30) in the double-blind relapse prevent trial (phase 2). Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.|||units on a scale||Standard Deviation|Mean
2841887|NCT00149799|Secondary|Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)|We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.|Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14||||percentage of subjects who responded|||Number
2842103|NCT00147043|Secondary|Improvement in Liver Function|Number of participant that have liver function improvement in liver function|Day 1 to Day 60||||Participants|||Count of Participants
2841888|NCT00149799|Primary|Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)|We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.|Phase II: Biweekly for six months after randomization|Intent-to-treat analysis of all 58 patients randomized to Phase II.|||percentage of subjects who relapsed|||Number
2841889|NCT00149747|Secondary|Peak Exercise Oxygen Consumption|Peak oxygen consumption measured during symptom limited treadmill exercise stress test|12 months||||mL of 02 per Kg per minute||Standard Deviation|Mean
2841890|NCT00149747|Secondary|Sleep Disturbances|"Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance.~All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances."|12 months|Intent to treat|||units on a scale||Standard Deviation|Mean
2841891|NCT00149747|Primary|% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline|Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).|baseline, 12 months|Intent to Treat|||percentage of sleep time||Standard Deviation|Mean
2841892|NCT00149669|Other Pre-specified|Cocaine Positive Urine Samples|The number of urine samples that were positive for cocaine|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
2841893|NCT00149669|Other Pre-specified|Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse|The percentage of urine and breath samples that are negative for other drugs of abuse|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
2841894|NCT00149669|Other Pre-specified|Cost Benefit Analysis|The costs and economic benefits of the intervention|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
2841895|NCT00149669|Other Pre-specified|HIV Risk Behaviors|Behaviors that place participants at risk for acquiring or transmitting HIV|6 months|These data were not analyzed due to limited funding. Funding this project has ended and we have no money to continue any summary or analyses.||||||
2841896|NCT00149669|Secondary|Percentage of Urine Samples Negative for Opiates|The number of urine samples negative for opiates divided by the total number of urine samples times 100.|6 months|intent to treat|||Percentage of Urine Samples||Full Range|Mean
2841897|NCT00149669|Secondary|Percentage of Urine Samples Negative for Cocaine|the number of urine samples that were negative for cocaine divided by the total number of urine samples) x 100|6 months|intent to treat|||Percentage of Urine Samples||Full Range|Mean
2841898|NCT00149669|Primary|Percentage of Urine Samples Positive for Naltrexone|The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.|6 months|intent to treat|||Percentage of Urine Samples||Full Range|Mean
2841899|NCT00149643|Secondary|Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.|Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.|12 Weeks||||Number of DSM-IV criterion||Standard Deviation|Mean
2841900|NCT00149643|Primary|Depression Symptoms at Week 12|Average of Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10 and 12. The BDI is a subject reported measure that has a minimim score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scare (63). Each DSM-IV criteron asses a different depressive symptom.|12 Weeks||||BDI Total||Standard Deviation|Mean
2841901|NCT00149643|Primary|Days Per Week of Cannabis Use.|The number days out of the last seven days that cannabis was used.|12 Weeks||||Days of cannabis use per week||Standard Deviation|Mean
2841902|NCT00149630|Secondary|Retention by Treatment Condition.|Treatment retention for full 12 weeks of study.|12 weeks|74 cocaine and opioid-codependent(DSM-V)subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250 mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduced DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.|||% of subjects who complete 12 wks study|||Number
2841903|NCT00149630|Primary|Urine Toxicology for Cocaine.||Thrice weekly, baseline through week 14.|74 cocaine and opioid-codependent (DSM-V) subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduces DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.|||% cocaine + urines over 2 week blocks||Standard Error|Mean
2841904|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)|Median change from baseline of tumor necrosis factor (TNF-alpha) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)|Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)||||pg/mL||Full Range|Median
2841905|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)|Median change from baseline of Interleukin-6 (IL-6) 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)|Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)||||pg/mL||Full Range|Median
2841906|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)|Median change from baseline of Interferon (INF) gamma 8 hours post NV1020 infusion (Visits 1, 3, 5, 7)|Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7)||||pg/mL||Full Range|Median
2841907|NCT00149396|Primary|Clinical Laboratory Safety - Coagulation|Number of patients with post-baseline clinically significant laboratory coagulation abnormalities by NV1020 dose cohort|Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment||||participants|||Number
2841908|NCT00149396|Primary|Clinical Laboratory Safety - Chemistry|Number of patients with post-baseline clinically significant laboratory chemistry abnormalities by NV1020 dose cohort|Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment||||participants|||Number
2841909|NCT00149396|Primary|Clinical Laboratory Safety - Hematology|Number of patients with clinically significant hematology laboratory abnormalities by NV1020 dose cohort (Post baseline)|Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment||||participants|||Number
2841910|NCT00149396|Primary|NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin|Number of patients with NV1020 detected in saliva, skin, and/or mucosal surfaces; Analysis by polymerase chain reaction (PCR)|Daily for 2 weeks after the first and last NV1020 infusions||||participants|||Number
2841911|NCT00149396|Secondary|Time to Disease Progression; Survival Time|Progression assessed from CT and PET measurements and is determined as an increase of greater than or equal to 25% in the sum of the products of perpendicular diameters of all tumors, or the appearance of any new lesion.|Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patient||||months||95% Confidence Interval|Median
2841912|NCT00149396|Secondary|Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay|Mean change from baseline in NV1020 neutralizing antibody titer by dose cohort|Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)||||antibody titer||Standard Deviation|Mean
2841913|NCT00149396|Secondary|Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment|Maximum percentage changes in tumor diameter after administration of NV1020 followed by chemotherapy as measured by CT scan and Modified Response Evaluation Criteria in Solid Tumors (RECIST) assessment|Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M)||||percentage|||Number
2841914|NCT00149396|Secondary|Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy||Screening (baseline), Chemo visit 1, Chemo visit 2, Follow-up Visit 1 (1 week after end of treatment), Follow-up Visit 2 (+6M), Follow-up Visit 3 (+9M), Follow-up Visit 4 (+12M)|"Number of participants analyzed decreases through the follow-up visits. Thus the Number of Participants Analyzed indicated here refer to the number at baseline."|||ng/mL||Standard Deviation|Mean
2841915|NCT00149396|Primary|Incidence of Adverse Events and Dose Limiting Adverse Events|Incidence of adverse events for all patients (N=32); Overall incidence ≥20%; Adverse events listed by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term|From start of treatment through 12 months after completion of treatment||||percentage of participants|||Number
2841916|NCT00149227|Secondary|Uncontrolled Blood Pressure, Etc.||five years|||||||
2841917|NCT00149227|Secondary|New Onset or Worsening of Diabetes Mellitus or IGT|"Diabetes mellitus was defined as fasting plasma glucose >=126 mg/dl, causal blood glucose >= 200 mg /dl, HbA1C >= 6.5%, and/or plasma glucose 2hr after 75g glucose load >= 200 mg/dl. The first of these events, new onset diabetes or worsening diabetes following IGT, occurring in a specific patient was classified as an event to be counted in the secondary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years||||event number|||Number
2841918|NCT00149227|Secondary|New Onset or Worsening of Arrhythmias||five years|||||||
2841919|NCT00149227|Secondary|Worsening of Cardiac Function||five years|||||||
2841920|NCT00149227|Secondary|All Cause Mortality||five years||||patients|||Number
2841921|NCT00149227|Primary|Transition to Dialysis, Doubling of Plasma Cr Levels|"The first of any events, transition to dialysis or doubling of plasma Cr levels compared to the entry, occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years||||event number|||Number
2841922|NCT00149227|Primary|New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans|Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
2841923|NCT00149227|Primary|New Onset of Acute Dissecting Aneurysm of the Aorta|Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
2841924|NCT00149227|Primary|Operation of PCI or Bypass Operation||five years|||||||
2841925|NCT00149227|Primary|Hospitalization Due to the New Onset, Occurrence or Worsening of Angina Pectoris and Additional Concomitant Use of Other Anti-anginal Agents or Increase of Dosage|Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
2842104|NCT00147043|Primary|Number of Participants With Serious Adverse Events Related to Injection|Incidence of serious adverse event related to injection with the study participants|Day 1 to Day 60||||Participants|||Count of Participants
2841926|NCT00149227|Primary|Hospitalization Due to the New Onset, Recurrence or Worsening of Heart Failure and Additional Concomitant Use of Other Anti-heart Failure Agents or Increase of Dosage|Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
2841927|NCT00149227|Primary|New Onset or Recurrence of Acute Myocardial Infarction|Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
2841928|NCT00149227|Primary|New Onset or Recurrence of Transient Ischemic Attack|Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years||||event number|||Number
2841929|NCT00149227|Primary|New Onset or Recurrence of Stroke|Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|Analyses were made by the independent Statistical Analysis Organization based on the intention-to-treat principle.|||event number|||Number
2841930|NCT00149214|Secondary|Disease-free Survival|Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.|baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)|All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.|||months||95% Confidence Interval|Median
2841931|NCT00149214|Secondary|Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery|Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy~Specimen for evaluation of pathological response obtained upon surgery~Treatment with at least one dose of study drug of the assigned study regimen."|||participants|||Number
2841932|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.|Cycles 5-8 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy up to surgery~Presence of measurable disease as defined by RECIST.~Treatment with at least one dose of study drug of assigned study regimen."|||participants|||Number
2841933|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.|Cycles 1-4 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy up to surgery~Presence of measurable disease as defined by RECIST.~Treatment with at least one dose of study drug of assigned study regimen."|||participants|||Number
2841934|NCT00149214|Primary|Number of Participants With a Pathological Complete Response|pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy~Specimen for evaluation of pathological response obtained upon surgery~Treatment with at least one dose of study drug of the assigned study regimen."|||participants|||Number
2841935|NCT00148954|Secondary|Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode||Time of event|||||||
2841936|NCT00148954|Secondary|Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)||Time of event|||||||
2841937|NCT00148954|Secondary|Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)||Time of event|||||||
2841938|NCT00148954|Primary|Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit|An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.|From date of pre-discharge until a minimum of 12 months follow-up until study closure||||Participants|||Number
2841939|NCT00148941|Secondary|Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits|Among assessed chronic illness(es) were: autoimmune disorders, asthma, type I diabetes, and allergies. AEs leading to emergency room (ER) visits or to physician office visits that were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis, and gastroenteritis.|During the extended safety follow-up phase (i.e. 5 months following the active phase [from Day 31 up to minimum 182 days post-vaccination])|The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all vaccinated subjects who had a follow-up contact during the ESFU period/who reported an unsolicited AE as specified in the protocol/onset of a chronic illness/SAE beyond Day 30, after the last vaccination.|||Participants|||Count of Participants
2841940|NCT00148941|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) that were assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination])|The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2841941|NCT00148941|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) post-vaccination period|The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2841942|NCT00148941|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination|Solicited general symptoms specific to M-M-R II vaccination were fever [≥ 37.5 degrees Celsius (°C)], rash/exanthem, parotid/salivary gland swelling, and suspected signs of meningism including febrile convulsions . Any = any symptom regardless of intensity grade. Grade 3 = symptom that prevented normal everyday activity. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever >39°C.|During the 15-day (Day 0-14) post-vaccination period|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.|||Participants|||Count of Participants
2841943|NCT00148941|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever (orally) [≥ 37.5 degrees Celsius (°C)] and loss of appetite. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever >39°C.|During the 4-day (Day 0-3) post-vaccination period|The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.|||Participants|||Count of Participants
2841944|NCT00148941|Secondary|Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site|Assessed specific symptom was increase in mid upper arm circumference (at the SB213503 & Infanrix injection sites). Any = any symptom regardless of intensity grade. Grade 3 increase in mid upper arm circumference = mid upper arm circumference greater than 30 mm.|During the 4-day (Day 0-3) post-vaccination period|The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.|||Participants|||Count of Participants
2841945|NCT00148941|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, and swelling (at the SB213503 & Infanrix vaccination sites). Any = any symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading up to or beyond 50 mm diameter.|During the 4-day (Day 0-3) post-vaccination period|The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.|||Participants|||Count of Participants
2841946|NCT00148941|Secondary|Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects|A seroprotected subject is defined as a vaccinated subject with anti-H1N1, anti-H3N2, and anti-B antibody titers greater than or equal to (≥) 1:40.|At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841967|NCT00148798|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT|||months||95% Confidence Interval|Median
2841968|NCT00148759|Primary|24-hr LPV AUC|Steady state(2 weeks after therapy change)|24 hours||||ng*hr/mL||Inter-Quartile Range|Geometric Mean
2841969|NCT00148759|Secondary|24-hr LPV Cmax|LPV Cmax at Steady State|24 hours||||ng/mL||Inter-Quartile Range|Geometric Mean
2841947|NCT00148941|Secondary|Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects|Seroconversion was defined as a post-vaccination haemagglutination-inhibition (HI) titer of ≥ 1:40 in an initially HI antibody seronegative subject (pre-vaccination HI titer < 1:10), or a ≥ 4 fold rise in HI titer in an initially HI antibody seropositive subject (pre-vaccination HI titer ≥ 1:10) The 3 flu strains assessed were H1N1, H3N2, and B.|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841948|NCT00148941|Secondary|Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects|GMTs were measured by hemagglutination inhibition assay and expressed in titers.|At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.|||Titers||95% Confidence Interval|Geometric Mean
2841949|NCT00148941|Secondary|Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects|Vaccine response defined as: For initially seronegative subjects (pre-booster antibody titer below cut-off of 1:8), an antibody titer ≥ 1:32 at one month after vaccination. For initially seropositive subjects (pre-booster antibody titer ≥1:8), an increase at least four times the pre-booster antibody titer at one month after vaccination.|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841950|NCT00148941|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL|The number of subjects with anti-D and anti-T antibody concentrations greater than or equal to (≥) 1 IU/mL is reported.|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841951|NCT00148941|Secondary|Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841952|NCT00148941|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody titers greater than or equal to 1:8.|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841953|NCT00148941|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841954|NCT00148941|Primary|Number of Subjects With Circumferential Swelling at the Injection Site|Swelling (at the SB213503 & Infanrix injection sites) was categorized as an increase of > or ≤ 30 mm in mid upper arm circumference compared to baseline measurement or with an increase in mid upper arm missing; extent of swelling > or ≤ 50 % of upper arm length, or diameter of injection site missing.|Within 4 days (Day 0-3) after vaccination|The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2841955|NCT00148941|Primary|Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects|Vaccine response defined as: For initially seronegative subjects [pre-booster antibody concentration below (<) cut-off of 5 EL.U/mL] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination.|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841970|NCT00148733|Secondary|Folate, Cobalamin and Vitamin D Status of the Enrolled Children|And whether or not these vitamins predict treatment failure and duration of illness.|14 days||2019-12-31|12/2019||||
2841971|NCT00148733|Secondary|Will Presence of a RNA Virus Modify the Effect of Zinc|We will compare the efficacy of zinc according to virus detected in nasopharyngeal secretions|14 days||2019-12-31|12/2019||||
2841956|NCT00148941|Primary|Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects|Vaccine response defined as: For initially seronegative subjects [pre-booster antibody concentration below (<) cut-off of 0.1 international units per milliliter (IU/mL)] with an increase of at least four times the cut-off one month after vaccination [post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination.|At Month 1 (i.e. one month after vaccination)|The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Participants|||Count of Participants
2841957|NCT00148941|Primary|Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects|GMTs were measured by Neutralization assay and expressed in titers.|At Month 1 (i.e. one month after vaccination)|The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||Titers||95% Confidence Interval|Geometric Mean
2841958|NCT00148941|Primary|Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects|GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL).|At Month 1 (i.e. one month after vaccination)|The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2841959|NCT00148941|Primary|Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects|GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).|At Month 1 (i.e. one month after vaccination)|The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2841960|NCT00148798|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|Safety Population|||participants|||Number
2841961|NCT00148798|Secondary|A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations|Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.|Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.||||ug/mL||Standard Deviation|Mean
2841962|NCT00148798|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 280/275; cycle 3 185/153; 6 month 101/97|||scores on a scale||Standard Error|Least Squares Mean
2841963|NCT00148798|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96|||scores on a scale||Standard Error|Least Squares Mean
2841964|NCT00148798|Secondary|Disease Control Rate|The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT|||percentage of participants||95% Confidence Interval|Number
2841965|NCT00148798|Secondary|Best Overall Response Rate|The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007||||percentage of participants||95% Confidence Interval|Number
2841966|NCT00148798|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT|||months||95% Confidence Interval|Median
2842960|NCT00140205|Primary|Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg|72-hour fasting Day 3 Leptin dose 0.1 mg/kg|3 DAY||||HR||Standard Deviation|Mean
2841974|NCT00148733|Secondary|Effect Modifiers for the Effect of Zinc Given During Pneumonia|We will also measure of there are factors at baseline that modifies the effect of zinc. Whether the following are modifiers for the above-mentioned effect of zinc given during pneumonia: i.severe inflammation, reflected in: high fever and/or elevated plasma C-reactive protein (CRP) concentration|Within 2 weeks after enrollment||2019-12-31|12/2019||||
2841975|NCT00148733|Primary|Adverse Effects|Vomiting, regurgitation, pain in abdomen for 15 minutes after zinc or placebo administration.|14 days||2019-12-31|12/2019||||
2841976|NCT00148733|Primary|Difference in Growth and Thymic Size Between the Treatment Groups Measured at Three and Six Months After the Zinc Supplementation|Thymus size will be measured using ultrasonography and compared between the two groups. at two occasions 2.5 and 6 months after end of supplementation|six months||2019-12-31|12/2019||||
2841977|NCT00148733|Primary|Active and Passive Morbidity Surveillance for Six Months After the 14-day Supplementation Period is Completed|We will measure to what extent short term zinc administration has an impact on growth and morbidity for up to 6 months after end of supplementation|six months||2019-12-31|12/2019||||
2841978|NCT00148733|Primary|Non-injury Clinic Visits and Hospital Admissions After Treatment Has Been Initiated|We will measure to what extent the intervention can reduce the number of severe events.|Within 2 weeks after enrollment||2018-12-31|12/2018||||
2841979|NCT00148733|Primary|Risk of Treatment Failure.|Enrolled children will be followed and given zinc or placebo for 14 days. We will compare the proportion with treatment failure (i.e. lack of improvement within 3 days) between the two groups|Within 2 weeks after enrollment||||participants|||Number
2841980|NCT00148668|Primary|Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer|Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery|12 weeks|Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.|||percentage of participants|||Number
2841981|NCT00148343|Secondary|Gait Speed||baseline, 12, 24 and 36 weeks||||meters/sec||Standard Deviation|Mean
2841982|NCT00148343|Secondary|Stroke-Specific Quality of Life Scale (SS-QOL)|"The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales.~Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245."|Weeks 0, 12, 24, 36||||Summary Score||Standard Deviation|Mean
2841983|NCT00148343|Secondary|Modified Emory Functional Ambulation Profile(mEFAP)|"The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the timed up-and-go test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds."|Weeks 0, 12, 24, 36||||seconds||Standard Deviation|Mean
2841984|NCT00148343|Secondary|Steps Per Minute|The number of steps taken by participants in one minute|Weeks 0, 12, 24, 36||||Steps/Min||Standard Deviation|Mean
2841985|NCT00148343|Primary|Fugl-Meyer Motor Assessment (FMA)|Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).|Weeks 0, 12, 24, 36|For intent-to-treat analysis, all participants who were randomized and completed baseline assessments were included in the analysis|||units on a scale||Standard Deviation|Mean
2841986|NCT00148317|Secondary|Progression Free Survival|"Response was assessed using IMWG guidelines, which for progressive disease are as follows:~Increase of > 25% from lowest response value in any one or more of the following:~Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*~Urine M-component and/or (the absolute increase must be > 200 mg/24 h)~Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL~Bone marrow plasma cell percentage; the absolute percentage must be > 10%~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is > 5g/dL, then absolute increase of 1g is sufficient for progression."|Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)||||months||Full Range|Median
2841987|NCT00148317|Secondary|Yield of CD34+ Stem Cells|This is the yield of CD34+ stem cells collection after high dose cyclophosphamide.|Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection||||10^6 cells/kg||Full Range|Median
2841988|NCT00148317|Primary|Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)|Myeloma response criteria developed by Bladé et al. was used to categorize response.|Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization|All 38 patients were treated with DoVeD consolidation therapy (Vel + DEX with or without DOXIL). Of the 38 patients enrolled, 27 proceeded to mobilization (11 did not undergo mobilization). Responses were assessed prior to mobilization (post DoVED), and again after mobilization, to see if mobilization improved patient response.|||participants|||Number
2842029|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
2841989|NCT00148122|Secondary|Probability of Progression Free Survival|The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval).|1 year post treatment|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.|||percentage of patients||95% Confidence Interval|Number
2841990|NCT00148122|Secondary|Frequency of Grade III/IV Toxicities Experienced by Participants|The frequency of grade 3 and grade 4 adverse events experienced by all treated participants.|30 days post treatment|40 patients were enrolled. 2 patients withdrew consent, therefore only 38 were included in the toxicity analysis.|||participants|||Number
2841991|NCT00148122|Primary|Overall Response Rate at 4 Months|Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 months|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.|||percentage of participants|||Number
2841992|NCT00148109|Secondary|Overall Survival|Time of cetuximab administration to clinically documented death assessed for four months|months||||months||95% Confidence Interval|Median
2841993|NCT00148109|Secondary|Progression Free Survival.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months|survival||||months||95% Confidence Interval|Median
2841994|NCT00148109|Primary|Number of Patients With Sarcoma Who Are Tumor Progression Free and Alive at Four Months From Start of Treatment With Single-agent Cetuximab.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy|4 months|per protocol all patients that received drug were evaluated for the primary endpoint|||participants|||Number
2841995|NCT00147966|Primary|American College of Rheumatology (ACR) 20 at Week 12|ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).|0 and 12 weeks||||participants|||Number
2841996|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks|Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
2841997|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Weeks|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
2841998|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 3 Months|Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
2841999|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 3 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
2842000|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Months|Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
2842001|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
2842002|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 12 Months|Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
2842030|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
2842003|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 12 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
2842004|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 18 Months|Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of trabeculation||Full Range|Mean
2842005|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 18 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.|||percentage of resorption||Full Range|Mean
2842006|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 24 Months|Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. .|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs at this time point.|||percentage of trabeculation||Full Range|Mean
2842007|NCT00147823|Primary|Resorption of Graft Material (GR) Compared at 24 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this timepoint.|||percentage of resorption||Full Range|Mean
2842008|NCT00147745|Primary|Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose|Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.|Baseline (Day -4) to first dose (Day 1)|The entire study population was included in this analysis|||mg*hr/dL||Standard Deviation|Mean
2842009|NCT00147745|Secondary|Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks|The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.|Baseline to 12 weeks|"One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.~The least squares mean is adjusted for baseline values. This corrects for differences in baseline values between treatment groups."|||percent||Standard Error|Least Squares Mean
2842010|NCT00147745|Secondary|The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks|The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.|Baseline to 12 weeks|One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.|||mg*hr/dL||Standard Error|Least Squares Mean
2842011|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.|The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.|||mg/kg/min||Standard Error|Least Squares Mean
2842012|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.|The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.|||mg/kg/min||Standard Error|Least Squares Mean
2842013|NCT00147537|Secondary|Duration of Response (DR) in Phase 2|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, duration of response was not analyzed.||||||
2842014|NCT00147537|Secondary|Time to Progression (TTP) in Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, time to progression was not was not analyzed.||||||
2842028|NCT00147537|Secondary|Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b|Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||ratio||Standard Deviation|Mean
2842015|NCT00147537|Secondary|Progression-Free Survival (PFS): Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments.|||months||90% Confidence Interval|Median
2842016|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Cmax was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.||||||
2842017|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2|Concentration at 504 hours post dose|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|C504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.||||||
2842018|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|AUC504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.||||||
2842019|NCT00147537|Secondary|Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2|Systemic clearance.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Clearance (CL) were not calculated based on the status of the program and the limited value this further PK analyses would provide.||||||
2842020|NCT00147537|Secondary|Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|Volume of distribution (Vd) was not calculated based on the status of the program and the limited value this further pharmacokinetic analyses would provide.||||||
2842021|NCT00147537|Secondary|The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2|"The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with '1' representing not at all and '4' very much. Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100."|Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for EORTC-QLQ-C30/-LC13 in phase 2.||||||
2842022|NCT00147537|Secondary|M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2|"The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was at its worst. Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was as bad as you can imagine or interfered completely with their life. Total average score range: 0 to 10."|Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for MDASI in phase 2.||||||
2842023|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2|HAHA are indicators of immunogenicity to CP-751,871|Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion|All participants who received any of the study treatments. N=number of participants who were analyzed for HAHA|||number of participants|||Number
2842024|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
2842025|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
2842026|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
2842027|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
2842081|NCT00147277|Secondary|Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention||one year|||||||
2842031|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||Day||Standard Deviation|Median
2842032|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||Day||Standard Deviation|Mean
2842033|NCT00147537|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
2842034|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg.hr/L||Standard Deviation|Mean
2842035|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||milligram.hour/Liter (mg.hr/L)||Standard Deviation|Mean
2842036|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b||Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||mg/L||Standard Deviation|Mean
2842037|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b||Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics|||milligram/liter (mg/L)||Standard Deviation|Mean
2842038|NCT00147537|Secondary|Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b|Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression|Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CTCs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.||||||
2842039|NCT00147537|Secondary|Number of Circulating Endothelial Cells (CECs): Phase 1b||Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CECs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.||||||
2842040|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b|HAHA are indicators of immunogenicity to CP-751,871.|Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)|All participants who received at least one dose of any agent. N=number of participants who were analyzed for HAHA|||number of participants|||Number
2842041|NCT00147537|Secondary|Objective Response Rate: Phase 1b|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received at least one dose of any agent. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment|||percentage of participants|||Number
2842042|NCT00147537|Primary|Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment|||percentage of participants||90% Confidence Interval|Number
2842093|NCT00147199|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a patient reported number between 0 (no perceived shortness of breath) and 10 (maximum perceived shortness of breath), obtained at the completion of each 6MWT.|12 weeks|Intention to treat population. A Week 12 observation was not present for one subject and that data point is not included in the analysis.|||score||Standard Deviation|Mean
2842415|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6|Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6|Month 6||||L||Standard Error|Mean
2842043|NCT00147537|Primary|Objective Response Rate: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment|||percentage of participants||90% Confidence Interval|Number
2842044|NCT00147537|Primary|Recommended Phase 2 Dose (RP2D): Phase 1b||Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.|||mg/kg|||Number
2842045|NCT00147537|Primary|Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b|The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.|Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.|||mg/kg|||Number
2842046|NCT00147498|Secondary|Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||participants|||Number
2842047|NCT00147498|Secondary|Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all participants who were randomized to study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for a particular time-point for each treatment arm, respectively.|||units on a scale||Standard Deviation|Mean
2842048|NCT00147498|Secondary|Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2842049|NCT00147498|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
2842050|NCT00147498|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mg/L||Standard Deviation|Mean
2842051|NCT00147498|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Mean
2842094|NCT00147199|Secondary|Clinical Worsening Events|Clinical worsening was defined as the first incidence of clinical worsening from randomization to the first occurrence of death, transplantation, hospitalization for PAH, or initiation of additional approved PAH therapy.|12 weeks|Intention to treat population|||clinical worsening events|||Number
2842416|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1|Month 1||||L||Standard Error|Mean
2842052|NCT00147498|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Error|Mean
2842053|NCT00147498|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
2842054|NCT00147498|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
2842055|NCT00147498|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
2842056|NCT00147498|Secondary|Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
2842057|NCT00147498|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
2842058|NCT00147498|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Error|Mean
2842059|NCT00147498|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Error|Mean
2842060|NCT00147498|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||swollen joints||Standard Error|Mean
2842061|NCT00147498|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Error|Mean
2842062|NCT00147498|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||tender joints||Standard Error|Mean
2842063|NCT00147498|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 6|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale*weeks||Standard Deviation|Mean
2842064|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2842065|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2842066|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||percentage of participants|||Number
2842067|NCT00147498|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2842068|NCT00147446|Secondary|No.of New or Enlarged T2 Lesions From Week 8 to Week 24|T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24||||participants|||Number
2842069|NCT00147446|Primary|No.of Gd+ Lesions From Week 8 to Week 24|Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24|A total of 121 patients with relapsing forms of MS were randomized to SMT-MS or WLC. Participants were enrolled at MS specialty clinics at 3 sites in the United States (UCSF; Evergreen Hospital Medical Center, and the Feinberg School of Medicine at Northwestern University, Chicago, Illinois) and through local chapters of the National MS Society.|||participants|||Number
2842070|NCT00147316|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours||||participants|||Number
2842071|NCT00147316|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months|The number of patients with a mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|at 3 months||||participants|||Number
2842072|NCT00147290|Secondary|Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF||one year|||||||
2842073|NCT00147290|Secondary|Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT||one year|||||||
2842074|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT||one year|||||||
2842075|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate FVT||one year|||||||
2842076|NCT00147290|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with GEE method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year||||Percent of VT episodes terminated|||Number
2842077|NCT00147277|Secondary|Evaluate Different Possible Predictors of ATP Success||one year|||||||
2842078|NCT00147277|Secondary|Compare Likelihood of Syncopal Events Associated With FVT||one year|||||||
2842079|NCT00147277|Secondary|Percent Reduction in Shocks Delivered Per Patient for Treating FVT||one year|||||||
2842080|NCT00147277|Secondary|Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms||one year|||||||
2842082|NCT00147277|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year|934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.|||Percentage of FVT episodes terminated|||Number
2842083|NCT00147238|Primary|Sensitivity of MRI Per Patient|Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).|MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI|Primary outcome measure was not assessed due to early study termination (e.g. patients did not receive assigned treatment).||||||
2842084|NCT00147225|Primary|Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.|||participants|||Number
2842085|NCT00147225|Primary|Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.|||participants|||Number
2842086|NCT00147212|Primary|The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response|Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)|Participants were followed until disease progression, an average of 6 months|Intent to treat|||participants|||Number
2842087|NCT00147199|Secondary|N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)|Change in NT pro-BNP from Baseline to Week 12. Plasma samples were collected from patients at Baseline and Week 12 in order to measure any change over time in circulating plasma levels of this biomarker.|12 weeks|Per protocol|||pg/mL||Inter-Quartile Range|Median
2842088|NCT00147199|Secondary|Change in Signs and Symptoms of PAH|"Signs and symptoms of PAH (Loud P2 sound, Ascites, Right ventricular S3 sound, Dyspnea, Right ventricular S4 sound, Orthopnea, Right ventricular heave, Dizziness, Murmur of tricuspid insufficiency, Syncope, Murmur of pulmonic insufficiency, Chest pain, Hepatomegaly, Palpitations, Jugular venous distension at 45 degrees, Fatigue, Edema) were assessed at Baseline and Week 12. The status of each sign and symptom (absent or present) was assessed at each visit. To assess overall change from baseline in signs and symptoms, a 1 was assigned for each sign and symptom that was present at the Week 12 but was absent at baseline, a -1 was assigned for each sign and symptom that was absent at Week 12 but was present at baseline, and a 0 was assigned for no change. An overall change score at each post-baseline assessment was then calculated by summing these values for all signs and symptoms. The overall change score had the potential to range from -17 to 17."|12 weeks|Intention to treat population.|||units on a scale||Full Range|Median
2842089|NCT00147199|Secondary|Quality of Life (Minnesota Living With Heart Failure)|Quality of life as measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire was evaluated at baseline and at Week 12. The MLWHF questionnaire consists of 21 questions assessing how the patient's heart failure has prevented them from living the way they wanted during the defined time period. Each question was graded by the patient with a numeric value between 0 (No/none) and 5 (very much). These scores were then summed across the 21 questions for a Global Score. Global scores ranged from 0 to 105. These questions were further grouped into Physical (8 of the questions) and Emotional (5 of the questions) dimensions to further characterize the effect of heart failure on the patient's life. Physical scores ranged from 0 to 40, and emotional scores ranged from 0 to 25. For all 3 categories, the lower the score, the better the outcome. Values presented as change from Baseline.|12 weeks|Intention to treat population.|||units on a scale||Inter-Quartile Range|Median
2842090|NCT00147199|Secondary|Peak 6MWD at Week 6|Change in peak 6MWD between Baseline and Week 6.|6 weeks|Intention to treat|||meters||Inter-Quartile Range|Median
2842091|NCT00147199|Secondary|Trough 6MWD at Week 12|Change in 6MWD from Baseline to trough 6MWD at Week 12. Trough was defined as a 6MWT conducted at least 4 hours following study drug inhalation.|12 Weeks|Intention to treat population|||meters||Inter-Quartile Range|Median
2842092|NCT00147199|Secondary|New York Heart Association (NYHA) Functional Classification|"Change in NYHA functional class at Week 12. NYHA classifications:~Class I - Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.~Class II - Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III - Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class IV - Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|12 weeks|Intention to treat population|||participants|||Number
2842105|NCT00147030|Secondary|Microcephaly|Head circumference at follow-up >2 standard deviations below the mean|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
2842106|NCT00147030|Secondary|Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment)||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
2842107|NCT00147030|Secondary|Sensorineural Hearing Loss|Normal or near normal hearing, no sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
2842108|NCT00147030|Secondary|Bayley Psychomotor Developmental Index Score (PDI)|Bayley Psychomotor Developmental Index score (PDI) <70|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
2842109|NCT00147030|Secondary|Multiple Handicap|defined as the presence of any two of the following in an infant; neuromotor disability (Level 3-5 on Gross Motor Function classification), mental delay (Bayley Mental Developmental Index (MDI) score < 70), epilepsy, cortical visual impairment, sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
2842110|NCT00147030|Secondary|Severe Neurodevelopmental Disability||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.|||participants|||Number
2842111|NCT00147030|Secondary|Mortality||18 months||||participants|||Number
2842112|NCT00147030|Secondary|Duration of Hospitalisation|Total duration of hospital care|Duration of hospital stay, on average 22 days||||days||Inter-Quartile Range|Median
2842113|NCT00147030|Secondary|Pulmonary Airleak||Duration of hospital stay, on average 22 days||||participants|||Number
2842114|NCT00147030|Secondary|Pneumonia||Before discharge from hospital||||participants|||Number
2842115|NCT00147030|Secondary|Renal Failure Treated With Dialysis||Duration of hospital stay, on average 22 days||||participants|||Number
2842116|NCT00147030|Secondary|Major Venous Thrombosis||Duration of hospital stay, on average 22 days||||participants|||Number
2842117|NCT00147030|Secondary|Thrombocytopenia||Duration of hospital stay, on average 22 days||||participants|||Number
2842118|NCT00147030|Secondary|Cardiac Arrhythmia|Arrhythmia identified on electrocardiogram (ECG), e.g. sinus bradycardia <80 beats per minute, ventricular arrhythmia.|Duration of hospital stay, on average 22 days||||participants|||Number
2842119|NCT00147030|Secondary|Necrotising Enterocolitis||Duration of hospital stay, on average 22 days||||participants|||Number
2842120|NCT00147030|Secondary|Culture Proven Sepsis||Duration of hospital stay, on average 22 days||||participants|||Number
2842121|NCT00147030|Secondary|Prolonged Blood Coagulation Time||Duration of hospital stay, on average 22 days||||participants|||Number
2842122|NCT00147030|Secondary|Pulmonary Hypertension||Duration of hospital stay, on average 22 days||||participants|||Number
2842123|NCT00147030|Secondary|Pulmonary Haemorrhage||Duration of hospital stay, on average 22 days||||participants|||Number
2842124|NCT00147030|Secondary|Persistent Hypotension|Hypotension was defined as a mean blood pressure of 40 mm Hg or less and was persistent if causes of hypotension had been sought and appropriate treatment provided, without success.|Duration of hospital stay, on average 22 days||||participants|||Number
2842125|NCT00147030|Secondary|Intracranial Haemorrhage|Intracranial hemorrhage was identified on magnetic resonance imaging (MRI).|Duration of hospital stay, on average 22 days||||participants|||Number
2842126|NCT00147030|Primary|Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors|Severe neurodevelopmental disability was defined as a score of less than 70 on the Mental Developmental Index of the Bayley Scales of Infant Development II (BSID-II) (on which the standardization mean [± standard deviation (SD)] is 100±15 and higher scores indicate better performance), a score of 3 to 5 on the Gross Motor Function Classification System (GMFCS) (on which scores can range from 1 to 5, with higher scores indicating greater impairment), or bilateral cortical visual impairment with no useful vision.|18 months||||participants|||Number
2842127|NCT00147017|Primary|Interleukin, IL-8||20 hours||||ng/ml||Standard Error|Mean
2842128|NCT00147017|Primary|Macrophage Activation, GM-CSF|GM-CSF, granulocyte macrophage-colony stimulating factor|20 hours||||ng/ml||Standard Error|Mean
2842129|NCT00147017|Primary|Macrophage Activation, TNF-a|measure release of inflammatory mediators from isolated macrophages|20 hours||||ng/ml||Standard Error|Mean
2842130|NCT00146848|Secondary|Change in Self Assessed Physical Activity|Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.|From randomization (6-weeks) through 12-month visit|Physical activity was assessed using the Physical Activity Scale for the Elderly and was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups. Postive values for changes denote improvements.|||units on a scale||Standard Deviation|Mean
2842131|NCT00146848|Primary|Clinical Composite Score|The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.|From randomization (6-weeks) through 12-month visit|This analysis is intention to treat (ITT) in terms of patient's being analyzed according to their randomized group. Last observation carried forward (LOCF) method was used for missing NYHA and global assessment measures at 12 months.|||participants|||Number
2842132|NCT00146848|Secondary|Change in Quality of Life|Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.|From randomization (6-weeks) through 12-month visit|Quality of Life was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups.|||units on a scale||Standard Deviation|Mean
2842133|NCT00146770|Other Pre-specified|Change From Baseline to Week 182 in Urinary GAG Level|Urinary Glycosaminoglycan (GAG) Levels: >> Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||ug GAG/mg Creatinine||Standard Deviation|Mean
2842134|NCT00146770|Secondary|Change From Baseline to Week 182 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one's arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Degrees||Standard Deviation|Mean
2842135|NCT00146770|Secondary|Change From Baseline to Week 182 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Units on a scale||Standard Deviation|Mean
2842136|NCT00146770|Secondary|Change From Baseline to Week 182 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Cubic centimeters (cm3)||Standard Deviation|Mean
2842137|NCT00146770|Secondary|Change From Baseline to Week 182 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.|||Events per Hour||Standard Deviation|Mean
2842138|NCT00146770|Primary|Change From Baseline to Week 182 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.|||Meters||Standard Deviation|Mean
2842139|NCT00146770|Primary|Change From Baseline to Week 182 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity: the maximal exhaled breath volume following a maximal inhaled breath. Overall change from Baseline to Week 182 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 182|This study enrolled patients who completed the Phase 3 Double-Blind Study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.|||percent predicted FVC||Standard Deviation|Mean
2842140|NCT00146757|Other Pre-specified|Investigator's Clinical Assessment at Week 52 Compared With Baseline|The Investigator's impression of the patient's overall clinical status at Week 52 compared with Baseline.|Baseline to 52 weeks|The analysis was intent-to-treat.|||participants|||Number
2842141|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Height|Change in Z-scores for standing height/lying-length-for-age from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Units on a scale||Standard Deviation|Mean
2842142|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Left Ventricular Mass (LVM) Z-Score|Change in LVM Z-scores as measured by echocardiography from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Units on a scale||Standard Deviation|Mean
2842143|NCT00146757|Other Pre-specified|Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline|Independent experts provided a global assessment for each sleep study visit as well as the degree of clinically meaningful change over the course of the study. Assessment was based on AHI, severity and frequency of oxygen desaturations and sleep quality.|Baseline to 52 weeks|The analysis was intent-to-treat.|||participants|||Number
2842144|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Apnea/Hypopnea Index (AHI)|Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events per hour indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Events per hour||Standard Deviation|Mean
2842145|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Liver Size (Hepatomegaly)|Percent change in extent of Liver Edge Below Right Costal Margin (BRCM) measured in centimeters from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Percentage of change||Standard Deviation|Mean
2842146|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Urinary Glycosaminoglycan (uGAG) Level|Percentage change in the concentration of GAG relative to creatinine (ug GAG/mg creatinine) in urine from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.|||Percentage of change||Standard Deviation|Mean
2842147|NCT00146757|Primary|Pharmacokinetics - Volume of Distribution (Vz)|Vz is the volume that relates the amount of drug in the body after absorption is complete to the concentration of drug in the plasma.|52 weeks|The analysis was intent-to-treat.|||liters/kilograms||Standard Deviation|Mean
2842148|NCT00146757|Primary|Pharmacokinetics - Total Plasma Clearance (CL)|CL is volume of the body fluid cleared of the drug per unit of time.|52 weeks|The analysis was intent-to-treat.|||(milliliters/minute)/kilograms||Standard Deviation|Mean
2842149|NCT00146757|Primary|Pharmacokinetics - Elimination Half Life (t1/2)|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|52 weeks|The analysis was intent-to-treat.|||hours||Standard Deviation|Mean
2842150|NCT00146757|Primary|Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)|AUC∞ is a measure of the total exposure to a drug.|52 weeks|The analysis was intent-to-treat.|||hours units/milliliters||Standard Deviation|Mean
2842151|NCT00146757|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|52 weeks|The number of participants was determined as adequate to assess the safety of Aldurazyme in young children with mucopolysaccharidosis I (MPS I). The analysis was intent-to-treat.|||participants|||Number
2842152|NCT00146640|Secondary|Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2842153|NCT00146640|Secondary|Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2842154|NCT00146640|Secondary|Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2842155|NCT00146640|Secondary|Relative Change From Baseline in Quality of Sleep at Week 12|Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2842156|NCT00146640|Secondary|Relative Change From Baseline in Pain Intensity at Week 12|Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2842157|NCT00146640|Secondary|Percentage of Participants With Recurrence of Joint Stiffness at Week 12|Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data. Percentage of participants who selected Yes for recurrence of joint stiffness, are reported.|Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
2842158|NCT00146640|Secondary|Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total DAS28 score range from 0 to approximately 10. DAS28 less than or equal to (≤) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 >5.1 = severe disease activity. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Mean
2842224|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Age of Donor at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||Years||Full Range|Median
2842159|NCT00146640|Primary|Relative Change From Baseline in Duration of Morning Stiffness at Week 12|Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.|Baseline, Week 12|ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2842160|NCT00146328|Secondary|Change From Baseline in CD4 Cell Count (LOCF)|Change from baseline in CD4 cell count with last observation carried forward(LOCF).|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4,1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed.|||cells/mm3||Standard Deviation|Mean
2842161|NCT00146328|Secondary|Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)|Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and rolled into 1182.17|||Log 10 copies/mL||Inter-Quartile Range|Median
2842162|NCT00146328|Primary|Number of Patients With Adverse Events Leading to Death|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842163|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842164|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842165|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842166|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842167|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842168|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842169|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842170|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17|||participants|||Number
2842227|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Engraftment Failure|Engraftment failure is defined as <10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost.|100 days post-transplantation||||proportion of engraftment failures||95% Confidence Interval|Number
2842171|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842172|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842173|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842174|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842175|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842176|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842177|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842178|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842179|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842180|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842181|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842182|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842228|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality|The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice.|100 days post-transplantation||||participants|||Number
2842417|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated FEV1 before bronchodilator at Month 1|Month 1||||L||Standard Error|Mean
2842183|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842184|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842185|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.|||participants|||Number
2842186|NCT00146172|Primary|Maximum Tolerated Dose (MTD)|If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.|From first dose date to day 14|All patients receiving neratinib in the dose escalation part of the study.|||mg|||Number
2842187|NCT00146172|Secondary|Clinical Benefit Rate|Patients with PR or higher responses or SD>=24 weeks, evaluable population|From first dose date to progression/death or last assessment, up to 39 weeks.|Breast, Lung and other solid tumors included in the efficacy evaluable population|||percentage of participants||95% Confidence Interval|Number
2842188|NCT00146172|Secondary|Objective Response Rate|Patients with PR or higher responses, evaluable population|From first dose date to progression/death or last assessment, up to 39 weeks|Breast, Lung and other solid tumors included in the efficacy evaluable population|||percentage of participants||95% Confidence Interval|Number
2842189|NCT00146172|Secondary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression or death, up to 39 weeks.|All subjects who were assigned to treatment, received at least 14 days of continuous dose administration of test article, and who had undergone at least 1 follow-up tumor assessment, evaluable population|||months||95% Confidence Interval|Median
2842190|NCT00146172|Secondary|Duration of Response|Duration of response of responders (PR+) by Kaplan-Meier estimate|From start date of response to first PD, up to 39 weeks.|Subjects responses classified as complete response or partial response in evaluable population|||months||95% Confidence Interval|Median
2842191|NCT00146172|Secondary|Number of Participants With Best Overall Response|Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), >=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start. The best overall response was the best response recorded from start of treatment until PD/recurrence. In general, the subject's best response assignment depended on achievement of both measurement and confirmation criteria.|From first dose date to progression or last tumor assessment, up to 39 weeks.|Subjects who had received at least 14 days of continuous dose administration of test article and who had undergone at least 1 follow-up tumor assessment, evaluable population|||Participants|||Count of Participants
2842192|NCT00146172|Primary|Dose Limiting Toxicity (DLT)|DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.|From first dose date to day 14|Subjects in the dosing groups 40 mg through 400 mg, excluding the selection of MTD.|||Participants|||Count of Participants
2842193|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24|The Percent Change in Radiographic Texture Analysis (RTA) spectral density coefficient beta (BETA) from Baseline to Month 24 is an analysis of spectral density vs. the spacial frequency on a log-log plot. BETA is the coefficient (slope) of this plot. Higher values of beta correspond to rougher (strong bone) and lower values to smoother, higher-frequency texture pattern (washed out bone).|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842194|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24|The Percent Change in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) from Baseline to Month 24 is a description of the similarity of texture of the images at different magnifications. The Minkowski fractal dimension is calculated from the slope of the least -square fitted line relating log volume and log magnification.|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842225|NCT00145626|Secondary|Number of Incidences of Chronic GVHD.|"Chronic GVHD was graded according to Seattle Criteria: limited or extensive. Limited is defined as localized skin and/or hepatic dysfunction. Extensive is defined as one or more of the following:~generalized skin involvement~liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis~eye dryness with Schirmer's test <5 mm wetting~oral: involvement of salivary glands or oral mucosa~other: another target organ involvement"|Up to 5 years after transplant||||Participants|||Count of Participants
2842195|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24|To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals and FMP is calculated for each segment. We use minFMP (minimum FMP) to represent the lowest value of FMP across the 24 angular sectors corresponding to the special frequency in the most washed-out direction. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure.|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842196|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24|To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and FMP is calculated for each segment. We use iFMP (integrated FMP) as a measure of overall special frequency of the radiographic pattern. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure.|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842197|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24|"Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater.~To derive a measure of variability in the RMS in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. We use sdRMS (standard deviation of the RMS across the segments) as a measure of the direction dependence (anisotropy) of the trabeculae in the bone image."|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842198|NCT00145977|Secondary|Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24|"Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater.~To derive a measure of variability in the RMS in the region of interest in the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. The iRMS (integrated RMS) roughly corresponds to RMS averaged across all 24 angular sectors"|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842199|NCT00145977|Secondary|Changes in Total Hip BMD +/- Treatment With Alendronate|Percent Change in total hip BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842200|NCT00145977|Secondary|Changes in Femoral Neck BMD +/- Treatment With Alendronate|Percent Change in femoral neck BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842201|NCT00145977|Secondary|Changes in Peripheral Heel BMD +/- Treatment With Alendronate|Percent Change in peripheral heel BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842202|NCT00145977|Primary|Changes in Lumbar Spine BMD +/- Treatment With Alendronate|Percent Change in lumbar spine BMD from Baseline to Month 24|Baseline to Month 24|Three missing values in Alendronate group and five missing values in control group were not imputed.|||Percent Change||Standard Deviation|Mean
2842203|NCT00145795|Secondary|Rates of Virologic Failure|Virologic failure defined as HIV RNA > 2,000 copies/mL|6 months||||percentage of randomized subjects|||Number
2842204|NCT00145795|Secondary|Clinical HIV-related Events|"Number of participants experiencing clinical HIV-related events as defined by category A, category B, and Appendix B in the 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults (http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm)."|6 months||||number of participants with event(s)|||Number
2842205|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [6 Months]||6 months||||percent apoptosis||Standard Deviation|Mean
2842206|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [3 Months]||3 months||||percent apoptosis||Standard Deviation|Mean
2842207|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [6 Months]||6 months||||percent apoptosis||Standard Deviation|Mean
2842208|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [6 Months]||6 months||||percent apoptosis||Standard Deviation|Mean
2842226|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD)|The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice.|100 days post-transplantation||||Number of Deaths|||Number
2842209|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months||||percent apoptosis||Standard Deviation|Mean
2842210|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months||||percent apoptosis||Standard Deviation|Mean
2842211|NCT00145795|Primary|Immune Reconstitution [6 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 6 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|6 months||||cells per cubic millimeter||Standard Deviation|Mean
2842212|NCT00145795|Primary|Immune Reconstitution [3 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 3 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|3 months||||cells per cubic millimeter||Standard Deviation|Mean
2842213|NCT00145704|Primary|Change in Total Body Bone Mineral Density During an 18 Month Period|For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.|18 months|Data analyis halted, due to low enrollment,no outcomes to report||||||
2842214|NCT00145626|Secondary|Kinetics of Lymphohematopoietic Reconstitution|The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|From 0-3 months after HSCT through 4-5 years after HSCT|Data was not available for analysis for all patients at all time points.|||cells *10^3/µl||Full Range|Median
2842215|NCT00145626|Secondary|Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation|The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately.|Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT|MRD data was collected on only four participants during at least one time point.|||Participants|||Count of Participants
2842216|NCT00145626|Secondary|Incidence of and Risk Factors for Long-term Neurocognitive Deficit.|The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant|There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study.||||||
2842217|NCT00145626|Secondary|Incidence of and Risk Factors for Organ Dysfunction.|The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant|There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study.||||||
2842218|NCT00145626|Secondary|Factors Affecting One-year Survival: Minimal Residual Disease (MRD)|Detection of leukemia blasts in bone marrow by flow cytometry|Up to one year after transplant|Only four of the 14 participants had MRD measured at the one-year time point.|||participants|||Number
2842219|NCT00145626|Secondary|Factors Affecting One-year Survival: Match N/6 HLA Loci|HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||participants|||Number
2842220|NCT00145626|Secondary|Factors Affecting One-year Survival: Donor Type|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||participants|||Number
2842221|NCT00145626|Secondary|Factors Affecting One-year Survival: Disease Status at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||participants|||Number
2842222|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of NK Cells|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||NKcells X 10^6/kg||Full Range|Median
2842223|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of CD34|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant||||CD34 X 10^6/kg||Full Range|Median
2842229|NCT00145626|Primary|One-year Survival|"The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system.~The Kaplan-Meier estimate for one-year survival is reported."|One year after transplant||||percentage of participants|||Number
2842230|NCT00145600|Other Pre-specified|Event-free Survival Probability by Risk Group at 10-year Follow-Up|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|10-year follow-up after protocol enrollment|||||||
2842231|NCT00145600|Secondary|Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842232|NCT00145600|Secondary|Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842233|NCT00145600|Secondary|Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842234|NCT00145600|Secondary|Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842235|NCT00145600|Secondary|Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842961|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg|72-hour fasting Day 3 Leptin dose 0.01 mg/kg|3 DAY||||NG*H/ML||Standard Deviation|Mean
2842236|NCT00145600|Secondary|Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842237|NCT00145600|Secondary|Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842238|NCT00145600|Secondary|Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842239|NCT00145600|Secondary|Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.|||units on a scale||Standard Deviation|Mean
2842240|NCT00145600|Secondary|Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
2842241|NCT00145600|Secondary|Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
2842242|NCT00145600|Secondary|Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
2842243|NCT00145600|Secondary|Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
2842244|NCT00145600|Secondary|Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
2842245|NCT00145600|Secondary|Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.|||units on a scale||Standard Deviation|Mean
2842246|NCT00145600|Primary|Event-free Survival Probability by Risk Group|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|Median 6.4 year follow-up|Nine patients were ineligible for analysis.|||probability of 5 yr. event free survival||95% Confidence Interval|Number
2842247|NCT00145587|Primary|Engraftment|To determine the need for blood or platelet transfusions and the presence of donor cells being present in the transplant recipient's bone marrow or peripheral blood by 100 day after transplantation for children with malignant infantile osteopetrosis who have received a haploidentical stem cell graft.|100 days post-transplant|From September 2004 to March 2009, 5 consecutive MIOP patients were treated using mismatched family member donors. Favorable engraftment refers to the transplant patient not requiring blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood.|||Participants|||Number
2842248|NCT00145574|Secondary|Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842249|NCT00145574|Secondary|Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842265|NCT00145509|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).|up to 52 weeks||||Participants|||Number
2842250|NCT00145574|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842251|NCT00145574|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842252|NCT00145574|Secondary|Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.|Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842253|NCT00145574|Secondary|Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842254|NCT00145574|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent-to-Treat (ITT) Population. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842255|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.|Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842256|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.|Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842257|NCT00145574|Secondary|Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842258|NCT00145574|Secondary|Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842259|NCT00145574|Secondary|Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.|Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842260|NCT00145574|Secondary|Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.|Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842261|NCT00145574|Primary|Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.|||percent change from baseline||Standard Deviation|Mean
2842262|NCT00145509|Primary|Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score|The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.|||Score on a scale||Standard Deviation|Mean
2842263|NCT00145509|Primary|Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score|The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.|||Score on a Scale||Standard Deviation|Mean
2842264|NCT00145509|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Participants who discontinued study medication due to adverse events.|40 weeks||||participants|||Number
2842266|NCT00145496|Secondary|Change From Baseline in Body Weight||Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.|||kg||Standard Error|Mean
2842267|NCT00145496|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.|||Units on a Scale||Standard Error|Mean
2842268|NCT00145496|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.|||Units on a Scale||Standard Error|Mean
2842269|NCT00145470|Secondary|Least Squares Mean Change From Baseline at Day 84 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2)|Least squares mean change from baseline at day 84 in quality of life was assessed, as determined by SF-36v2. The SF-36v2 is a self-administered questionnaire, measuring 8 domains: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); and Mental Health (MH). These 8 concepts are further organized into a Physical Component Summary (PCS; composite of PF, RP, BP, and GH) and a Mental Component Summary (MCS; composite of VT, SF, RE, and MH). The SF-36v2 domains and composite summaries were scored using a norm-based scoring approach, yielding a mean of 50 and standard deviation of 10 based on the norms from the 1998 SF-36 United States general population norms. For the PCS and MCS, scores range from 0 to 100, with higher scores indicating better quality of life. Further, decreases in quality of life (by PCS and MCS) are reflected by a negative change from baseline.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842270|NCT00145470|Secondary|Least Squares Mean Change From Baseline at Day 21 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2)|Least squares mean change from baseline at day 21 in quality of life was assessed, as determined by SF-36v2. The SF-36v2 is a self-administered questionnaire, measuring 8 domains: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); and Mental Health (MH). These 8 concepts are further organized into a Physical Component Summary (PCS; composite of PF, RP, BP, and GH) and a Mental Component Summary (MCS; composite of VT, SF, RE, and MH). The SF-36v2 domains and composite summaries were scored using a norm-based scoring approach, yielding a mean of 50 and standard deviation of 10 based on the norms from the 1998 SF-36 United States general population norms. For the PCS and MCS, scores range from 0 to 100, with higher scores indicating better quality of life. Further, decreases in quality of life (by PCS and MCS) are reflected by a negative change from baseline.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842271|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 84|The least squares mean change from baseline in Q-LES-Q score at day 84 was assessed. The Q-LES-Q is a participant-completed questionnaire to assess general satisfaction with activities such as physical health, mood, work, household tasks, social and family relationships, leisure activities, and overall satisfaction, composed of 16 items. For each of the 16 items, scores range from 0 (very poor) to 5 (very good), with scores for all items adding to a total score (range: 0-80); higher scores indicate better quality of life. Further, decreases in quality of life are reflected by a negative change from baseline.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842272|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 21|The least squares mean change from baseline in Q-LES-Q score at day 21 was assessed. The Q-LES-Q is a participant-completed questionnaire to assess general satisfaction with activities such as physical health, mood, work, household tasks, social and family relationships, leisure activities, and overall satisfaction, composed of 16 items. For each of the 16 items, scores range from 0 (very poor) to 5 (very good), with scores for all items adding to a total score (range: 0-80); higher scores indicate better quality of life. Further, decreases in quality of life are reflected by a negative change from baseline.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842279|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 21|The least squares mean change from baseline in HAM-A score at day 21 was assessed. The HAM-A is a clinician-rated instrument for assessing anxiety symptoms, composed of 14 items. For the 14 items, scores range from 0 (not present) to 4 (severe). Scores for individual items add to a total score (range: 0-56), with higher scores indicating greater severity of anxiety. Further, decreases in anxiety severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842273|NCT00145470|Secondary|Percentage of Participants Determined to be Ready to Discharge at Day 84 (Kaplan-Meier Estimation)|"The percentage of participants determined to be ready to discharge at day 84 was estimated (Kaplan-Meier), using the readiness to discharge questionnaire (RDQ). The RDQ is clinician-rated scale to assess readiness for discharge, composed of 7 items. Of the 7 items, only the first 5 items were utilized:~Not actively suicidal/homicidal;~Adequate control over aggression and impulsivity;~Able to carry out basic activities of daily life;~Able to take medicine independently; and~Delusions and hallucinations do not significantly interfere with functioning.~For the 5 items, the clinician provided a response (Strongly Disagree; Disagree; Agree; or Strongly Agree) at each pre-specified visit. The first visit at which the responses to the first 5 items on the RDQ are Strongly Agree or Agree, was defined as the point a participant was ready to discharge."|Day 84|Per protocol, the analysis population for this endpoint includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment.|||Percentage of Participants||95% Confidence Interval|Number
2842274|NCT00145470|Secondary|Mean Change From Baseline (CFB) at Day 84 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery|"Nine neurocognitive tests with higher scores indicating better performance:~Verbal Memory test: recognize/remember/retrieve words (range 0-60)~Visual Memory test: recognize/remember/retrieve geometric figures (range 0-60)~Speed of Processing: recognize/process information. No min./max. score. Normative average (NA); correct answers: 65.1, avg. errors: 1.37~Social Acuity/Perception of Emotions test: perceive/respond to emotional cues. Min. score: -64/Max. score: 16~Reasoning: reason/respond to non-verbal, visual-abstract stimuli; scores range: -15 to 15~Executive Function: recognize rules/categories/decision making. No min./max. score. NA correct answers: 55.01/avg. errors: 5.28~Working Memory/Continuous Performance Task (CPT): perceive/attend to symbols. Min. score: -45/Max. score: 15~Sustained Attention: direct/focus on specific stimuli: Max. score (raw score); 45; Min. score: -170~Composite Memory: working+verbal+visual memory, Range 0-135."|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Deviation|Mean
2842275|NCT00145470|Secondary|Mean Change From Baseline (CFB) at Day 21 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery|"Nine neurocognitive tests with higher scores indicating better performance:~Verbal Memory test: recognize/remember/retrieve words (range 0-60)~Visual Memory test: recognize/remember/retrieve geometric figures (range 0-60)~Speed of Processing: recognize/process information. No min./max. score. Normative average (NA); correct answers: 65.1, avg. errors: 1.37~Social Acuity/Perception of Emotions test: perceive/respond to emotional cues. Min. score: -64/Max. score: 16~Reasoning: reason/respond to non-verbal, visual-abstract stimuli; scores range: -15 to 15~Executive Function: recognize rules/categories/decision making. No min./max. score. NA correct answers: 55.01/avg. errors: 5.28~Working Memory/Continuous Performance Task (CPT): perceive/attend to symbols. Min. score: -45/Max. score: 15~Sustained Attention: direct/focus on specific stimuli: Max. score (raw score); 45; Min. score: -170~Composite Memory: working+verbal+visual memory, Range 0-135."|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Deviation|Mean
2842276|NCT00145470|Secondary|Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 84|The least squares mean change from baseline in ISST-Modified score at day 84 was assessed. The ISST-Modified is a clinician-rated scale for rating suicidality, composed of 12 items (score range: 0-2). Scores for the 12 items add to a total ISST-Modified score (range: 0-24), with higher scores indicating increased severity of suicidal thinking. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842277|NCT00145470|Secondary|Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 21|The least squares mean change from baseline in ISST-Modified score at day 21 was assessed. The ISST-Modified is a clinician-rated scale for rating suicidality, composed of 12 items (score range: 0-2). Scores for the 12 items add to a total ISST-Modified score (range: 0-24), with higher scores indicating increased severity of suicidal thinking. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842278|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 84|The least squares mean change from baseline in HAM-A score at day 84 was assessed. The HAM-A is a clinician-rated instrument for assessing anxiety symptoms, composed of 14 items. For the 14 items, scores range from 0 (not present) to 4 (severe). Scores for individual items add to a total score (range: 0-56), with higher scores indicating greater severity of anxiety. Further, decreases in anxiety severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842280|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 84|The least squares mean change from baseline in PANSS score at day 84 was assessed. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and add to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842281|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 21|The least squares mean change from baseline in PANSS score at day 21 was assessed. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and add to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842282|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 84|The least squares mean change from baseline in MADRS score at day 84 was assessed. The MARDS is a clinician-rated scale for assessing the severity of symptoms of depression, composed of 10 items. For the 10 items, scores range from 0 (symptoms absent) to 6 (severe). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater severity of depression. Further, decreases in depression severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842283|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 21|The least squares mean change from baseline in MADRS score at day 21 was assessed. The MARDS is a clinician-rated scale for assessing the severity of symptoms of depression, composed of 10 items. For the 10 items, scores range from 0 (symptoms absent) to 6 (severe). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater severity of depression. Further, decreases in depression severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842284|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 84|The least squares mean change from baseline in CGI-BP severity of severity of overall bipolar illness score at day 84 was assessed. The CGI-BP severity of overall bipolar illness scale is a clinician-rated scale for assessing the severity of overall symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842285|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 21|The least squares mean change from baseline in CGI-BP severity of severity of overall bipolar illness score at day 21 was assessed. The CGI-BP severity of overall bipolar illness scale is a clinician-rated scale for assessing the severity of overall symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842332|NCT00145041|Primary|T 1/2|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.|cycle 1 day 1|all patients enrolled|||hr||Standard Deviation|Mean
2842286|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 84|The least squares mean change from baseline in CGI-BP severity of depression score at day 84 was assessed. The CGI-BP severity of depression scale is a clinician-rated scale for assessing the severity of depressive symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842287|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 21|The least squares mean change from baseline in CGI-BP severity of depression score at day 21 was assessed. The CGI-BP severity of depression scale is a clinician-rated scale for assessing the severity of depressive symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842288|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 84|The least squares mean change from baseline in CGI-BP severity of mania score at day 84 was assessed. The CGI-BP severity of mania scale is a clinician-rated scale for assessing the severity of manic symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842289|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 21|The least squares mean change from baseline in CGI-BP severity of mania score at day 21 was assessed. The CGI-BP severity of mania scale is a clinician-rated scale for assessing the severity of manic symptoms of bipolar disorder, with scores ranging from 1 (normal) to 7 (very severely ill). Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Per protocol, the overall analysis population includes all randomized participants receiving ≥1 dose of study treatment, with ≥1 post-dose Y-MRS assessment. For Baseline / Change from Baseline data, includes only participants of the overall analysis population with an observation at the time indicated for the respective endpoint.|||Score on a Scale||Standard Error|Least Squares Mean
2842290|NCT00145470|Secondary|Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Remitter Status|The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. At pre-specified time points, the number of participants achieving Y-MRS remitter status was assessed, defined as the number of participants with a Y-MRS total score of 12 or lower. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Up to Day 84|Includes all randomized participants receiving ≥1 dose of study treatment, having ≥1 post-dose Y-MRS assessment.|||Participants|||Count of Participants
2842291|NCT00145470|Secondary|Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Responder Status|The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. At pre-specified time points, the number of participants achieving Y-MRS responder status was assessed, defined as the number of participants with a 50% decrease from baseline in Y-MRS total score. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Up to Day 84|Includes all randomized participants receiving ≥1 dose of study treatment, having ≥1 post-dose Y-MRS assessment.|||Participants|||Count of Participants
2842292|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 84|The least squares mean change from baseline in Y-MRS score at day 84 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 84|Includes all randomized participants receiving ≥1 dose of study treatment, having ≥1 post-dose Y-MRS assessment.|||Score on a Scale||Standard Error|Least Squares Mean
2842372|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24||||L||Standard Error|Mean
2842373|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24||||L||Standard Error|Mean
2842293|NCT00145470|Secondary|Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 42|The least squares mean change from baseline in Y-MRS score at day 42 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a LOCF analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 42|Includes all randomized participants receiving ≥1 dose of study treatment, having ≥1 post-dose Y-MRS assessment.|||Score on a Scale||Standard Error|Least Squares Mean
2842294|NCT00145470|Secondary|Number of Participants Discontinuing Study Treatment Due to an AE|The number of participants discontinuing study treatment due to an AE was assessed. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the use of the investigational product, whether or not considered related to the investigational product.|Up to Day 84|Includes all randomized participants receiving ≥1 dose of study treatment.|||Participants|||Count of Participants
2842295|NCT00145470|Secondary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing an AE was assessed. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the use of the investigational product, whether or not considered related to the investigational product.|Up to Day 114|Includes all randomized participants receiving ≥1 dose of study treatment.|||Participants|||Count of Participants
2842296|NCT00145470|Primary|Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21|The least squares mean change from baseline in Y-MRS score at day 21 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a last observation carried forward (LOCF) analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.|Baseline and Day 21|Includes all randomized participants receiving ≥1 dose of study treatment, having ≥1 post-dose Y-MRS assessment.|||Score on a Scale||Standard Error|Least Squares Mean
2842297|NCT00145418|Secondary|Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.|Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.|day one of cycle one until participant removed from trial|all participants had adverse events|||participants|||Number
2842298|NCT00145418|Secondary|Duration of Response|Duration of response is a measure of how long the participants response to therapy was maintained.|0 -12 months||||months||Full Range|Median
2842299|NCT00145418|Secondary|Time to Progression|Progression is measured from each participants start of study until removal from treatment.|<1 cycle to 6 cycles of treatment||||months||Full Range|Median
2842300|NCT00145418|Primary|Response Rate|Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.|Response is measured every 2 cycles until disease progression||||Participants|||Number
2842301|NCT00145327|Secondary|The Number of Participants With Clinically Significant Laboratory Parameters|Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||Participants|||Number
2842302|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||μmol/L||Standard Deviation|Mean
2842303|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||μmol/L||Standard Deviation|Mean
2842304|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.|||μmol/L||Standard Deviation|Mean
2842305|NCT00145327|Secondary|Qualitative Bone Biopsy Parameters|Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).|End of Study Visit at Year 6|Bone Biopsy sub-population.|||Participants|||Number
2842374|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18||||L||Standard Error|Mean
2842306|NCT00145327|Secondary|Number of Participants With Incidence of Clinical Fracture|Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.|Extension Baseline (Year 3; Month 36) to Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. n = the number of patients with measurements at Year 6 as determined by the analysis window.|||Participants|||Number
2842307|NCT00145327|Secondary|Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures|Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 as determined by the analysis window.|||Percentage of patients|||Number
2842308|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
2842309|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
2842310|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
2842311|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
2842312|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.|||Percentage change in BMD||Standard Error|Mean
2842313|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.|||Percentage Change in BMD||Standard Error|Mean
2842314|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 6: P1NP|The amount of serum P1NP as determined by the central laboratory|Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The Number of patients analyzed = the number of patients with measurements in Year 6 as determined by the analysis window.|||ng/mL||Standard Error|Mean
2842315|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP|The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.|Year 4.5|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 as determined by the analysis window.|||ng/mL||Standard Error|Mean
2842316|NCT00145327|Primary|Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3|The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 − femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)|Modified intent-to-treat (MITT) population. The MITT population included all patients in the ITT population who had DXA measurements of the femoral neck at Year 3 and Year 6. This was the primary population for primary efficacy parameter.|||Percentage Change in BMD||Standard Error|Mean
2842375|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18||||L||Standard Error|Mean
2842317|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 168|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 168|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
2842318|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 70|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 70|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
2842319|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 42|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 42|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
2842320|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 14|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 14|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.|||Scores on a scale||Standard Deviation|Mean
2842321|NCT00145249|Secondary|Number of Cryptococcal Isolates With Antifungal Susceptibility|Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.|Days 14 and 70|The study team has since determined that the assay that was to be utilized did not have sufficient sensitivity/specificity for its intended purpose and therefore these results will not be generated.|||Isolates|||Number
2842322|NCT00145249|Secondary|Mean Days of Hospitalization|Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.|7, 14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.|||Days||Standard Deviation|Mean
2842323|NCT00145249|Secondary|Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)|"Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment.~Day = Day relative to first dose of study drug"|14, 42, and 70 days|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data|||Subjects|||Number
2842324|NCT00145249|Secondary|Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success|Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive|14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.|||Subjects|||Number
2842325|NCT00145249|Secondary|Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points|Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.|Baseline, 14, 42, and 70 days|The modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.|||Subjects|||Number
2842326|NCT00145249|Secondary|Number of Deaths|"Number of deaths occurring on study.~Day = Day relative to the first dose of study drug."|14, 42, and 70 days|The Regulatory Safety Population was used in this analysis, which includes all subjects who were randomized, who received at least 1 dose of study drug, and who have any on-study data.|||Subjects|||Number
2842327|NCT00145249|Primary|Number of Dose-limiting Toxicities Attributed to Treatment Regimens|"Events are reported by MedDRA Preferred Term.~Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.|||Events|||Number
2842328|NCT00145249|Primary|Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug|"Events are reported by MedDRA Preferred Term.~Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention.~Grade 4 - Life-threatening. AE is life-threatening.~Grade 5 - Death. AE causes death."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.|||Events|||Number
2842329|NCT00145119|Primary|ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)|ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)|2 year||||participants|||Number
2842330|NCT00145041|Primary|Volume of Distribution|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour|cycle 1 day 1|all patients enrolled|||mL/m2||Standard Deviation|Mean
2842331|NCT00145041|Primary|Clearance|The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2|Day 1 of Cycle 1|All subjects enrolled|||ml/h/m2||Standard Deviation|Mean
2842333|NCT00144963|Primary|MTD of VSLI|Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.|6 weeks|This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.|||mg/m2|||Number
2842334|NCT00144781|Secondary|Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.|||meters||95% Confidence Interval|Mean
2842335|NCT00144781|Secondary|Percent Change From Baseline to Week 26 in Liver Organ Volume|A greater decrease in liver volume indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.|||Percentage of Change in Liver Volume||95% Confidence Interval|Mean
2842336|NCT00144781|Primary|Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Level|Urinary GAG Level - Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to 26 Weeks|Based on the changes in urinary GAG levels observed in the Phase 3 double-blind study, a sample size of 8 patients per group would have sufficient power to detect a 29 percentage point difference between groups in the mean change in urinary GAG levels as being statistically significant. The analysis was intention to treat.|||Percentage of Change in GAG Level||95% Confidence Interval|Mean
2842337|NCT00144391|Primary|Fatigue Impact Scale|change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated|6 months||||units on a scale||Standard Deviation|Mean
2842338|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842339|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842340|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842341|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842342|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842343|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842344|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842345|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842346|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842347|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842348|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842349|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Angina)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842376|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12||||L||Standard Error|Mean
2842350|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days||||Number of patients with event|||Number
2842351|NCT00144339|Secondary|Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)|The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used|Day 1 to day 1470||||Participants|||Number
2842352|NCT00144339|Secondary|Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)|The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days||||Participants|||Number
2842353|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)|All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.|Day 1 to day 1470||||Participants|||Number
2842354|NCT00144339|Post-Hoc|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)||Day 1 to day 1440||||Participants|||Number
2842355|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)|On-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days||||Participants|||Number
2842356|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 48||||Units on a scale||Standard Error|Mean
2842357|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 42||||Units on a scale||Standard Error|Mean
2842358|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 36||||Units on a scale||Standard Error|Mean
2842359|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 30||||Units on a scale||Standard Error|Mean
2842360|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 24||||Units on a scale||Standard Error|Mean
2842361|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 18||||Units on a scale||Standard Error|Mean
2842362|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 12||||Units on a scale||Standard Error|Mean
2842363|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 6||||Units on a scale||Standard Error|Mean
2842364|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48||||L||Standard Error|Mean
2842365|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48||||L||Standard Error|Mean
2842366|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42||||L||Standard Error|Mean
2842367|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42||||L||Standard Error|Mean
2842368|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36||||L||Standard Error|Mean
2842369|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36||||L||Standard Error|Mean
2842370|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30||||L||Standard Error|Mean
2842371|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30||||L||Standard Error|Mean
2842418|NCT00144339|Secondary|Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)|From Day 1 to 4 years||||days/patient year||Standard Error|Mean
2842419|NCT00144339|Secondary|Number of Exacerbation Leading to Hospitalization|Estimated number of exacerbations leading to hospitalizations per patient year|From Day 1 to 4 years||||Number per patient year|||Number
2842420|NCT00144339|Secondary|Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization||From Day 1 to 4 years||||Participants|||Number
2842421|NCT00144339|Secondary|Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)||Day 1 to 4 years||||months||95% Confidence Interval|Median
2842422|NCT00144339|Secondary|Number of Exacerbation Days Per Patient Year|Number of exacerbation days normalized by treatment exposure|Day 1 to 4 years||||days/patient year||Standard Error|Mean
2842423|NCT00144339|Secondary|Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation||Day 1 to 4 years||||Participants|||Number
2842424|NCT00144339|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year||Day 1 to 4 years||||number per patient year||Standard Error|Mean
2842425|NCT00144339|Secondary|Time to First Exacerbation|Chronic obstructive pulmonary disease (COPD) exacerbation|From Day 1 to 4 years||||months||95% Confidence Interval|Median
2842426|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
2842427|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
2842428|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
2842429|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.||||ml/year||Standard Error|Median
2842430|NCT00144339|Secondary|Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).|From month 6 to 4 years||||Score on scale per year||Standard Error|Mean
2842431|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
2842432|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
2842433|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
2842434|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years||||ml/year||Standard Error|Mean
2842435|NCT00144339|Secondary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days||||ml/year||Standard Error|Median
2842436|NCT00144339|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.||||ml/year||Standard Error|Median
2842437|NCT00144339|Primary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years||||ml/year||Standard Error|Mean
2842458|NCT00144300|Secondary|Expert Panel Overall Assessment Following 1 Year on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 1 years|FAS LOCF - full analysis set with last observation carry forward|||Participants|||Number
2842438|NCT00144339|Primary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years||||ml/year||Standard Error|Mean
2842439|NCT00144300|Secondary|Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs|Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.|Screen (Baseline) and final visit (24 months)|TSlab - treated set with non-missing laboratory evaluations|||participants|||Number
2842440|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 2 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842441|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|2 years|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842442|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842443|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842444|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842445|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 2 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842446|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|2 years|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842447|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842448|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842449|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842450|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 2 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842451|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|2 years|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842452|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842453|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|1 year|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842454|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline|TS - treated set|||Score on a scale||Standard Deviation|Mean
2842455|NCT00144300|Secondary|Hoehn and Yahr Scale at 2 Years|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 2 years|TS - treated set|||Participants|||Number
2842456|NCT00144300|Secondary|Hoehn and Yahr Scale at 1 Year|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 1 year|TS - treated set|||Participants|||Number
2842457|NCT00144300|Secondary|Hoehn and Yahr Scale at Baseline|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Baseline|TS - treated set|||Participants|||Number
2842459|NCT00144300|Primary|Expert Panel Overall Assessment Following 2 Years on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 2 years|FAS LOCF - full analysis set with last observation carry forward|||Participants|||Number
2842460|NCT00144170|Secondary|Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.|"Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.~The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time."|up to 75 weeks of treatment|Safety Set (SAF), included all patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2842461|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 96)||Baseline to Week 96|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842462|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 88)||Baseline to Week 88|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842463|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 80)||Baseline to Week 80|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842464|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 72)||Baseline to Week 72|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842465|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 64)||Baseline to Week 64|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842466|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 56)||Baseline to Week 56|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842467|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 48)||Baseline to Week 48|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842468|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 40)||Baseline to Week 40|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842469|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 32)||Baseline to Week 32|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842470|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 24)||Baseline to Week 24|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842471|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 16)||Baseline to Week 16|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842472|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 8)||Baseline to Week 8|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842473|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 4)||Baseline to Week 4|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842474|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 2)||Baseline to Week 2|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count|||Cells/mm3||Standard Deviation|Mean
2842475|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<50 copies/mL|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842476|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<50 copies/mL|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842477|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<50 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842478|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<50 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842479|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<50 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842480|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<50 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842481|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<50 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842482|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<50 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842483|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<50 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842484|NCT00144170|Secondary|Virologic Response at Week 24|Viral Load < 50 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842485|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<50 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842486|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<50 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842487|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<50 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842488|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<50 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842489|NCT00144170|Secondary|Virologic Response|Virologic response defined as Viral Load<50 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842490|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<400 copies/mL|week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842491|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<400 copies/mL|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842492|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<400 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842493|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<400 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842494|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<400 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842495|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<400 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842496|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<400 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842497|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<400 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842498|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response defined as Viral Load<400 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842499|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<400 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842500|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<400 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842501|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<400 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842502|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<400 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842503|NCT00144170|Secondary|Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks|Virologic response defined as Viral Load<400 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842504|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<400 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842505|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 96)||Baseline to Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842506|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 88)||Baseline to Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842507|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 80)||Baseline to Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842508|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 72)||Baseline to Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842509|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 64)||Baseline to Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842510|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 56)||Baseline to Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842511|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 48)||Baseline to Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842512|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 40)||Baseline to Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842513|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 32)||Baseline to Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842514|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 24)||Baseline to Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842515|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 16)||Baseline to Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842516|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 8)||Baseline to Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842517|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 4)||Baseline to Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842518|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 2)||Baseline to Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2842519|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842520|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842521|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842522|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842523|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842524|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842525|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842526|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842527|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842528|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842529|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842530|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842531|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842532|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842533|NCT00144170|Secondary|Virologic Response|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842534|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2842535|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2842536|NCT00144170|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2842537|NCT00144170|Secondary|Treatment Response at Week 96|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842538|NCT00144170|Secondary|Treatment Response at Week 88|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842539|NCT00144170|Secondary|Treatment Response at Week 80|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842540|NCT00144170|Secondary|Treatment Response at Week 72|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842541|NCT00144170|Secondary|Treatment Response at Week 64|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842542|NCT00144170|Secondary|Treatment Response at Week 56|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842543|NCT00144170|Secondary|Treatment Response at Week 40|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842544|NCT00144170|Secondary|Treatment Response at Week 32|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842545|NCT00144170|Secondary|Treatment Response at Week 24|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842546|NCT00144170|Secondary|Treatment Response at Week 16|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842547|NCT00144170|Secondary|Treatment Response at Week 8|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2842548|NCT00144170|Secondary|Treatment Response at Week 4|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842549|NCT00144170|Secondary|Treatment Response at Week 2|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842550|NCT00144170|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2842551|NCT00144170|Primary|Treatment Response at Week 48|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2842552|NCT00144027|Primary|Antipsychotic Medication Adherence|The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.|6-months|"Percent of participants who reported never missed taking my medication at 6-months"|||percentage of participants|||Number
2842553|NCT00143845|Secondary|Percentage of Patients Alive at 2 Years|To estimate the overall survival of patients progression following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.|2 Years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.|||percentage of participants|||Number
2842554|NCT00143845|Primary|Percentage of Participants With Progression Free Survival|"The second primary objective was to determine the percentage of participants with progression free survival following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.~We define disease progression as disease recurrence within 180 days of transplant."|two years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.|||percentage of participants|||Number
2842555|NCT00143845|Primary|Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4|"The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows:~Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement"|100 days|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.|||percentage of participants|||Number
2842556|NCT00143819|Secondary|Photography of Target Lesions|Number of participants with photographs taken|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||Participants|||Count of Participants
2842557|NCT00143819|Secondary|Change in Target Lesion Scoring|The subjects' target lesions (ie, a pair of roughly symmetrical bilateral lesions) on each side of the body were scored by the investigator at each visit. Percent change from baseline was calculated.|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||percent change||Standard Deviation|Mean
2842558|NCT00143819|Secondary|Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels|For subjects with eczema, a global assessment (scale of 0-5: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe) was performed and a score recorded for each side of the subject's body, at each visit.|8 weeks|The five (5) subjects in the study who had eczema were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||Participants|||Count of Participants
2842559|NCT00143819|Secondary|Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels|For subjects with psoriasis, a global assessment (scale of 0-5: 0 = clear except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe) was performed and a score recorded for each side of the subject's body, at each visit.|8 weeks|The eight (8) subjects in the study who had psoriasis were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||Participants|||Count of Participants
2842560|NCT00143819|Primary|Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks|Subjects assessed the level of pruritus (itching) on the left and right sides of their body at each visit, ticking the values on a 100-mm scale (0 mm = no itching; 100 mm = worst possible itching) for each side. Percent change from baseline was calculated.|8 weeks|Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body.|||percent change||Standard Deviation|Mean
2842561|NCT00143598|Secondary|Quality of Life|"The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.~The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale."|24 months|Patients who completed the SF-36 and VEINES-QOL at 24 months follow-up.|||Scores on a scale||Standard Deviation|Mean
2842563|NCT00143598|Secondary|Severity of PTS, Including Incidence of Venous Ulcer|"Highest Villalta at or after 6 month visit~The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score >4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; >14 points or presence of an ulcer, severe).~Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score."|6-24 months.|Highest Villalta score at or after 6 month visit (missing for 48 patients in each group).|||participants|||Number
2842564|NCT00143598|Primary|Incidence of Post-thrombotic Syndrome (PTS)||During 2-year follow up|Intention to treat.|||participants|||Number
2842565|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.||||participants|||Number
2842566|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
2842567|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
2842568|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
2842569|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.||||participants|||Number
2842570|NCT00143507|Secondary|Hospitalisation for Unstable Angina||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||participants|||Number
2842571|NCT00143507|Secondary|Hospitalisation for Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||participants|||Number
2842572|NCT00143507|Secondary|Coronary Artery Disease Death|Death due to heart failure, acute myocardial infarction or cardiac procedure|From the date of randomisation to death, up to 3 years.||||participants|||Number
2842573|NCT00143507|Secondary|All-cause of Mortality||From the date of randomisation to death, up to 3 years.||||participants|||Number
2842574|NCT00143507|Secondary|Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||participants|||Number
2842575|NCT00143507|Secondary|Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of first occurrence of the event, up to 3 years.||||Participants|||Number
2842576|NCT00143507|Secondary|Cardiovascular Death|Cardiovascular death including sudden death of unknown cause|From the date of randomisation to death, up to 3 years.||||participants|||Number
2842577|NCT00143507|Primary|Primary Composite Endpoint|First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).|From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.||||participants|||Number
2842578|NCT00143455|Secondary|Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)|Improvement of ≥ 1 tumor related symptom = clinical benefit responder. Pain improvement = decrease of ≥ 1 National Cancer Institute (NCI) grade from baseline of ≥ 1 symptom of NCI pain category, without pain symptom worsening. Cough, dyspnea and hemoptysis improvement = decrease of ≥ 1 NCI grade from baseline. Positive weight change ≥ 5 percent gain from baseline. Positive analgesic consumption = change from baseline from opioid to non-opioid category.|Every 3 weeks for up to 6 months on study treatment|Data were not analyzed.|||participants|||Number
2842579|NCT00143455|Secondary|European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)|The EORTC QLQ-C30 scales include 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/QL scale and 9 symptom scales: nausea and vomiting, pain, fatigue, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QL represents a high QL (better patient state), and for a symptom scale/item represents a high level of symptomatology/problems (worse patient state).|Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up|Data were not analyzed.|||scores on a scale||Standard Deviation|Mean
2842580|NCT00143455|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to the date of the first documentation of tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.|Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.|||months||95% Confidence Interval|Median
2842581|NCT00143455|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients) of Cohort 2 (after the 29 September 2003 protocol amendment), analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer.|||months||95% Confidence Interval|Median
2842582|NCT00143455|Primary|Overall Survival for the Per Protocol (PP) Population|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|PP population = a subset of the Cohort 2 FAP. The subjects had to be eligible (subject had no major protocol deviations from inclusion and noninclusion criteria), evaluable for response, without any major protocol deviations during the study.|||months||95% Confidence Interval|Median
2842583|NCT00143455|Secondary|Number of Subjects With Overall Confirmed Response|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.|||participants|||Number
2842584|NCT00143455|Primary|Overall Survival (OS) for the Full Analysis Population (FAP)|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.|||months||95% Confidence Interval|Median
2842585|NCT00143403|Secondary|Overall Survival Rates|Probability of being alive was calculated in a yearly increment.|Median follow-up time (42 months)|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).|||survival rate|||Number
2842586|NCT00143403|Primary|Disease Free Survival (DFS)|time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|last tumor assessment date or cut-off date, whichever is earlier.|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).|||months||95% Confidence Interval|Median
2842587|NCT00143390|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||95% Confidence Interval|Median
2842588|NCT00143390|Secondary|Overall Survival (OS)|OS is defined as time from the date of randomization to the date of death.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||95% Confidence Interval|Median
2842589|NCT00143390|Secondary|Number of Participants With Clinical Benefit - Investigator Assessment|Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.|||participants|||Number
2842590|NCT00143390|Secondary|Number of Participants With Objective Response - Investigators Assessment|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.|||participants|||Number
2842613|NCT00142935|Secondary|Drug Use|Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews||||participants|||Number
2842591|NCT00143390|Secondary|Time to Progression (TTP) - Investigators Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||90% Confidence Interval|Median
2842592|NCT00143390|Primary|Time to Progression (TTP) - Expert Evaluation Committee Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.|||months||95% Confidence Interval|Median
2842593|NCT00143312|Secondary|Survival Without Proven or Probable Invasive Fungal Infection (IFI)|Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits|6 months, 12 months|Complete case analysis using MITT population (ie, all subjects who had at least 1 dose of study medication & at least 1 post-enrollment efficacy assessment & a previous diagnosis of proven or probable IFI, confirmed by Data Review Committee) & either provided an IFI assessment at follow-up visit, died or experienced an IFI before that visit.|||participants|||Number
2842594|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)|Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Two subjects experienced a recurrent proven or probable IFI.|||days|||Number
2842595|NCT00143312|Secondary|Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. One subject in the MITT population experienced a new IFI.|||days|||Number
2842596|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Three subjects in the MITT population experienced an IFI.|||days|||Number
2842597|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit|150 days|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).|||participants|||Number
2842598|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up|6 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).|||participants|||Number
2842599|NCT00143312|Primary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up|12 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).|||participants|||Number
2842600|NCT00143247|Primary|Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||mL/min/mm Hg||Standard Deviation|Mean
2843761|NCT00129727|Secondary|Response Rate (RECIST-1)|To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.|5 years||||Percentage of Participants||95% Confidence Interval|Number
2842601|NCT00143247|Secondary|Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.|6 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||participants|||Number
2842602|NCT00143247|Secondary|Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||participants|||Number
2842603|NCT00143247|Secondary|Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment|Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||participants|||Number
2842604|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)|Observed values by duration of treatment.|6 to 120 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent binding||Full Range|Median
2842605|NCT00143247|Primary|Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||liters||Standard Deviation|Mean
2842606|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)|observed values by duration of treatment.|36 to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent binding||Full Range|Median
2842607|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes|Observed values by duration of treatment.|36 months to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent binding||Full Range|Median
2842608|NCT00143247|Secondary|Severe Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.|0-132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||severe events / 100 subject-months|||Number
2842609|NCT00143247|Secondary|Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.|0 to 132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||events / subject-month|||Number
2842610|NCT00143247|Secondary|Change in Glycosylated Hemoglobin by Duration of Exubera Treatment|Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.|||percent HbA1C||Standard Deviation|Mean
2842611|NCT00142935|Secondary|Non-fatal Overdose|Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews||||participants|||Number
2842612|NCT00142935|Secondary|Fatal Overdose|Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.|Within six months from release of incarceration||||participants|||Number
2845568|NCT00114634|Secondary|ABC Total Score|ABC total score includes all the questions from subscales, with range of 0 to 174. Higher the score , the greater the problem.|2 weeks||||units on a scale||Standard Error|Mean
2842614|NCT00142935|Primary|HIV Risk Behaviors - Self Report|Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews||||participants|||Number
2842615|NCT00142935|Primary|Time to MMT Initiation Post Release Based on Clinic Chart Review|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.|within 30 days post release from incarceration|Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.|||days||Standard Deviation|Mean
2842616|NCT00142935|Primary|Treatment Engagement|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.|within 30 days post release of incarceration|We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.|||participants|||Number
2842617|NCT00142909|Secondary|Diastolic Blood Pressure||12 weeks||||mm Hg||Standard Deviation|Mean
2842618|NCT00142909|Secondary|Diastolic Blood Pressure||1 Week||||mm Hg||Standard Deviation|Mean
2842619|NCT00142909|Secondary|Systolic Blood Pressure||12 weeks||||mm Hg||Standard Deviation|Mean
2842620|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|12 weeks||||units on a scale||Standard Deviation|Mean
2842621|NCT00142909|Secondary|Systolic Blood Pressure||1 Week||||mm Hg||Standard Deviation|Mean
2842622|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|1 Week||||units on a scale||Standard Deviation|Mean
2842623|NCT00142818|Secondary|Naltrexone/Modafinil-treated Subjects Will Have Fewer Days of Cocaine Use, More Abstinent Days From Alcohol, and Fewer Heavy Drinking Days During the Follow up Period Compared to Placebo-treated Subjects.||4+13 weeks|||||||
2842624|NCT00142818|Secondary|Modafinil-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks|||||||
2842625|NCT00142818|Secondary|Naltrexone-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks|||||||
2842626|NCT00142818|Primary|Number of Days of Abstinence From Drinking and Number of Days of Clinically Significant Drinking (Measured by Timeline Follow Back at Week 14 and the 6-month Evaluation)||4+13 weeks|||||||
2842627|NCT00142818|Primary|Cocaine Use (Measured by Timeline Follow Back and Urine Screen at Week 14)||13 weeks||||number of cocaine negative urine samples||Standard Deviation|Mean
2842628|NCT00142792|Secondary|Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation|The AMAT assesses upper limb specific tasks and does not allow for compensation. The AMAT consists of 13 compound ADL tasks composed of 1 to 3 component tasks, with a total of 28 component tasks. Each task was rated on the functional ability ordinal scale from 0-5 and an average is calculated, so the final score remains 0-5, with higher scores indicating lesser activity limitation. Total range of reported data is between 0 and 5 because the average is reported. 0 refers to no function. 5 refers to normal function.|AMAT will be administered on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.|All cases, intent to treat|||units on a scale||95% Confidence Interval|Least Squares Mean
2842629|NCT00142792|Primary|Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure|"The FMA battery measures six dimensions of post-stroke impairment including upper and lower limb motor impairment, range of motion, pain, reflexes, and sensation. , Each item (33 total) is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and summed to provide a score ranging from 0 to 66, where higher scores indicate better motor function The FMA was administered with the participant seated."|FMA will be administered on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.|All cases, intent-to-treat, adjusted for site|||units on a scale||95% Confidence Interval|Least Squares Mean
2842630|NCT00142597|Primary|Change in Mu-opioid Receptor Occupancy|Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.|measured from baseline to week 5||||Unitless: binding potential is Bmax/Kd||Standard Deviation|Mean
2842631|NCT00142519|Secondary|To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.||assessed every 10 minutes|Data not collected||||||
2842962|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg|72-hour fasting Day 3 Leptin dose 0.01 mg/kg|3 DAY||||NG/ML||Standard Deviation|Mean
2842632|NCT00142519|Primary|The Primary Goal of This Study is to Compare the Analgesic Effects of a Combination of Morphine and Methadone With Morphine Alone to Determine Synergistic Activity of mu Opioid Analgesics in Patients With Post-operative Pain.||Time to the third request for the pain medication|Data not collected||||||
2842633|NCT00142506|Primary|Assessment of Erectile Dysfunction|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline, 6 months, 12 months, 24 months||||units on a scale||Inter-Quartile Range|Median
2842634|NCT00142415|Secondary|Number of Subjects With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to RECIST v1.0 at baseline and at the end of every cycle (every 12 weeks) or after recovery from toxicity. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 9 months|The Evaluable Analysis Set comprises subjects who completed Cycle 1 (ie, received both 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250) and had at least 1 post-baseline response assessment. The Evaluable Analysis Set includes 23 subjects who completed Cycle 1, 12 subjects who completed Cycle 2, and 4 subjects who completed Cycle 3.|||participants|||Number
2842635|NCT00142415|Primary|Radiation Absorbed Doses by Organ for 177-Lu-cG250|After each 177-Lu-cG250 administration, 3 whole-body scintigrams were acquired (directly after injection and 2-4 days and 5-7 days post-injection) and blood samples were drawn at 5, 30, 60, and 120 min, 2-4 days, and 5-7 days post-infusion. Estimated radiation absorbed doses were calculated according to the Medical Internal Radiation Dose scheme, which permits estimation of the factors required to calculate dose to one organ attributable to a source in another organ.|12 weeks|The Dosimetry Evaluable Analysis Set comprises all subjects who received at least 1 dose of 177-Lu-cG250.|||mGy/MBq||Standard Deviation|Mean
2842636|NCT00142415|Primary|Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1|Subjects were monitored for AEs for ≥ 8 weeks after the last infusion of 177-Lu-DOTA-cG250 before dose escalation could be implemented. Toxicity was graded in accordance with the NCI CTCAE version 3.0. DLT was defined as the following treatment-related events: ≥ Grade 3 non-hematologic toxicity; ≥ Grade 4 hematologic toxicity (platelets < 25 × 10^9/L or leukocytes < 1.0 × 10^9/L) that persisted for > 4 weeks except anemia; thrombocytopenia < 10 × 10^9/L; clinically relevant myelotoxicity that required hospitalization and/or blood product transfusion (e.g., uncontrolled bleeding, infections that had to be treated clinically).|12 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.|||participants|||Number
2842637|NCT00142415|Primary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the NCI CTCAE version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 1 year|The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.|||participants|||Number
2842638|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]|"The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.~Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated."|52 weeks,104 weeks|"In Group C: other feeder study reporting group, there were only 13 patients; hence, no summary statistics were performed. Only listings were generated."||||||
2842639|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]|The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks,104 weeks|The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint.|||Percentage of Participants||95% Confidence Interval|Number
2842640|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|52 weeks,104 weeks|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.|||Percentage of Participants||95% Confidence Interval|Number
2842692|NCT00141778|Secondary|Acute Renal Failure|Percentage of patients with a creatinine concentrations >2.5mg/dl|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average, depending on the study group.|The intention-to-treat analysis included anyone who had received any study medication.|||percentage of patients|||Number
2842641|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.|||Percentage of Participants||95% Confidence Interval|Number
2842642|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.|||Percentage of Participants||95% Confidence Interval|Number
2842643|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.|||Percentage of Participants||95% Confidence Interval|Number
2842644|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.|||Percentage of participants||95% Confidence Interval|Number
2842645|NCT00142298|Secondary|To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
2842646|NCT00142298|Secondary|To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
2842647|NCT00142298|Secondary|To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
2842648|NCT00142298|Secondary|To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment||52 weeks, 104 weeks, 156 weeks, 208 weeks|||||||
2842649|NCT00142168|Secondary|Minor Response Rate|A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.|||participants|||Number
2842650|NCT00142168|Secondary|Major Response Rate|Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.|||participants|||Number
2842651|NCT00142168|Primary|Overall Response|Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.|||participants|||Number
2842652|NCT00142168|Primary|Time to Progression|Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.|34.3 months|All enrolled patients|||months||Full Range|Median
2842653|NCT00142116|Primary|Time to Progression|Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.|49.1 months||||months||Full Range|Median
2842654|NCT00142116|Secondary|To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.||3 years|||||||
2842963|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg|72-hour fasting Day 3 Leptin dose 0.01 mg/kg|3 DAY||||HR||Standard Deviation|Mean
2842655|NCT00142116|Primary|Objective Response Rate|Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).|3 years|Intent-to-treat basis|||participants|||Number
2842656|NCT00141921|Secondary|Improvement From Study 20030211 Baseline in Joint Pain|"Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10).~Improvement from baseline = (Baseline Value - Post-baseline Value)."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264|Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2842657|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842658|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842659|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842660|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842661|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842662|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842663|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data, and with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842664|NCT00141921|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percentage of participants|||Number
2842665|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in PASI Score|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percent improvement||Standard Deviation|Mean
2842666|NCT00141921|Secondary|Percentage of Participants With a PASI 90 Response|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percentage of participants|||Number
2842667|NCT00141921|Secondary|Percentage of Participants With a PASI 75 Response|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.|||percentage of participants|||Number
2842668|NCT00141921|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)|"A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product and with available data at each time point.|||percentage of participants|||Number
2842669|NCT00141921|Secondary|Number of Participants Who Developed Anti-etanercept Antibodies|"Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay.~Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline."|264 weeks|Participants who received at least one dose of investigational product and had a post-baseline antibody result.|||participants|||Number
2842670|NCT00141921|Secondary|Number of Participants With Grade 3 and 4 Laboratory Toxicities|The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.|264 weeks|Participants who received at least one dose of investigational product.|||participants|||Number
2842671|NCT00141921|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs||264 weeks|Participants who received at least one dose of investigational product.|||participants|||Number
2842672|NCT00141921|Secondary|Exposure-adjusted Adverse Event Rates|"The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period.~Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100.~Multiple occurrences of the same event for a participant were counted as multiple events."|264 weeks|Participants who received at least one dose of investigational product.|||events per 100 patient years|||Number
2842673|NCT00141921|Secondary|Number of Participants With Injection Site Reactions|An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.|264 weeks|Participants who received at least one dose of investigational product.|||participants|||Number
2842674|NCT00141921|Primary|Number of Participants With Adverse Events|"A serious adverse events is any AE that~is fatal~is life threatening~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity).~An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer."|264 Weeks|Participants who received at least one dose of investigational product.|||participants|||Number
2842675|NCT00141817|Primary|Plasma Concentrations After Multiple Doses||Hours 2 and 4 on Day 7|Multiple-Dose Valid-for-Evaluation Population: Randomized participants who had concentration evaluations of pantoprazole either at 2 hours or at 4 hours after single dose and after at least 5 consecutive doses. n=participants who had data available at that specific time point.|||ng/mL||Standard Deviation|Mean
2842676|NCT00141817|Primary|Terminal-Phase Volume of Distribution (Vz/F)|Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||liter per kilogram (L/kg)||Standard Deviation|Mean
2842677|NCT00141817|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||liter per hour per kilogram (L/h/kg)||Standard Deviation|Mean
2842678|NCT00141817|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||hours||Standard Deviation|Mean
2842679|NCT00141817|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||ng*h/mL||Standard Deviation|Mean
2842680|NCT00141817|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population.|||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2842681|NCT00141817|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.|||hours||Standard Deviation|Mean
2842682|NCT00141817|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2842683|NCT00141778|Secondary|Perioperative C-reactive Protein (CRP) Concentrations|C-reactive protein was measured at several time points (see table) over the course of the study.|Perioperative period|CRP was measured in all subjects from the intention-to-treat analysis for which plasma was available at those time points.|||ug/mL||Standard Deviation|Mean
2842684|NCT00141778|Secondary|Perioperative Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations|Plasminogen activator inhibitor-1 (PAI-1) was measured at several time points (see table) over the course of the study.|Perioperative period|PAI-1 was measured in all subjects in the intention-to-treat analysis for which plasma was available.|||ng/mL||Standard Deviation|Mean
2842685|NCT00141778|Secondary|Perioperative Interleukin(IL)-6 Concentrations|Interleukin-6 was measured at several time points (see time points in table) over the course of the study|Perioperative period|All participants included in the intention-to-treat analysis who had available plasma samples.|||pg/ml||Standard Deviation|Mean
2842686|NCT00141778|Secondary|Stroke|Percentage of patients in each study group who experience a cerebrovascular event, confirmed by CT.|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average depending on the study arm.|The intention-to-treat analysis included all those who received any study drug.|||percentage of patients|||Number
2842687|NCT00141778|Secondary|Death|The percentage of patients in each study arm who died.|Measured until the time of hospital discharge|The intention-to-treat analysis included all patients who received any study medication.|||percentage of patients|||Number
2842688|NCT00141778|Secondary|Length of Hospital Stay (Days)||Measured from the day of surgery until the time of hospital discharge|The intention-to-treat analysis included anyone who had received any study medication.|||days||Standard Deviation|Mean
2842689|NCT00141778|Secondary|Time to Tracheal Extubation|It is the time in minutes that it took to extubate the patient after surgery.|It is the time (in minutes) from admission to the ICU until tracheal extubation|The intention-to-treat analysis included all patients who received any study medication.|||minutes||Standard Deviation|Mean
2842690|NCT00141778|Secondary|Hypokalemia|Percentage of patients who had a serum potassium concentrations <3.5 milliequivalents (mEq)/L|Measured until the time of hospital discharge, which was an average of 5.7 to 6.8 days depending on the treatment arm.||||percentage of patients|||Number
2842691|NCT00141778|Secondary|Hypotension|Percentage of patients with hypotension defined as a systolic blood pressure <90 mmHg and/or prolonged requirement for vasopressor use.|Measured during and after surgery, until discharge, from 5.7 to 6.8 days on average.|The intention-to-treat analysis included anyone who had received any medication.|||percentage of patients|||Number
2842693|NCT00141778|Primary|Postoperative Atrial Fibrillation|The primary endpoint of the study was the percentage of patients with electrocardiographically confirmed AF of at least 10 secs duration at any time following the end of surgery until hospital discharge, an average from 5.7 days in the ramipril group to 6.8 days in the placebo group. Patients were monitored continuously on telemetry throughout the postoperative period until discharge. Electrocardiograms were obtained for any rhythm changes detected on telemetry monitoring, and in addition, electrocardiograms were performed preoperatively, at admission to the intensive care unit, and daily starting on postoperative day 1. All electrocardiograms and rhythm strips were reviewed in a blinded fashion by a single cardiac electrophysiologist.|Measured from admission to the ICU until discharge from hospital|Four hundred fifty-eight patients were randomized. Of these 445 took study medication and were included in the intention-to-treat analysis.|||percentage of patients|||Number
2842694|NCT00141765|Primary|Percent of Participants With Progression Free Survival at 1 Year|The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.|1 year post transplant||||percentage of participants|||Number
2842695|NCT00141739|Secondary|The Impact of Tumor Necrosis Factor (TNF) Polymorphisms on Response to Therapy.||100 days|This was not analyzed in the population and there are no plans to analyze this in the future. The study is complete and the principal investigator has left the institution.||||||
2842696|NCT00141739|Secondary|Day +7 TNFR1 Ratio in TBI-Treated Patients vs. Non-TBI-Treated Patients|The effect of etanercept on plasma cytokine levels after Hematopoietic Stem Cell Transplantation (HSCT) was analyzed. Tumor Necrosis Factor Receptor 1 (TNFR1) ratios (TNFR1 posttransplantation day+7 / TNFR1pretransplantation baseline were calculated. Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|Day+7, post transplant|TBI versus non-TBI transplant conditioning|||TNFR1 Ratio||Full Range|Mean
2842697|NCT00141739|Secondary|The Number of Patients That Experience Idiopathic Pulmonary Syndrome (IPS)|The Effect of etanercept on the incidence of idiopathic pulmonary syndrome (IPS). Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|100 days|TBI versus Non-TBI transplant conditioning|||Participants|||Count of Participants
2842698|NCT00141739|Secondary|Number of Patients Experiencing Etanercept Toxicity|Toxicity of etanercept was evaluated by the following: the number of patients experiencing allergic reactions, the number of patients that discontinued etanercept early, the number of patients experiencing bacteremia, and the number of patients experiencing viral reactivations.|100 days||||participants|||Number
2842699|NCT00141739|Primary|The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|"In order to determine whether etanercept, given prophylactically along with a standard Graft Versus Host Disease (GVHD) prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT), the incidence of grades 2-4 and grades 3-4 GVHD were calculated.~GVHD can be clinically graded as 0, I, II, III, or IV. Definition of grades are:~Grade 0 - No stage 1-4 of any organ Grade I - Stage 1-2 rash and no liver or gut involvement Grade II - Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gastrointestinal involvement Grade III - Stage 0-3 skin, with STage 2-3 liver, or Stage 2-3 gastrointestinal involvement Grade IV - Stage 4 skin, liver, or gastrointestinal involvement"|100 days|To provide Sufficient power|||percentage of participants|||Number
2842700|NCT00141726|Secondary|Percentage of Participants That Experience Grade 3 to 4 Adverse Events|To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.|continuously (and week 4, week 8 and week 12, week 20)|34 subjects were enrolled and evaluated for adverse events.|||percentage of participants|||Number
2842701|NCT00141726|Primary|Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO|Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .|week 12 post therapy|34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing <50% of scheduled dosing.|||percent evaluable participants|||Number
2842702|NCT00141518|Other Pre-specified|EQ-5D Visual Analog Scale (VAS) Score, up to Month 36|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842703|NCT00141518|Other Pre-specified|EQ-5D Descriptive Systems Summary Index Score, up to Month 36|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842825|NCT00141271|Secondary|Change in Digit Sequencing Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases|||Number Correct||Standard Error|Least Squares Mean
2842704|NCT00141518|Other Pre-specified|UPDRS Part IV Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842705|NCT00141518|Other Pre-specified|UPDRS Part III Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842706|NCT00141518|Other Pre-specified|UPDRS Part II Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842707|NCT00141518|Other Pre-specified|UPDRS Part I Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842708|NCT00141518|Other Pre-specified|UPDRS Total Score up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842709|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842710|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of accurate taps||Standard Deviation|Mean
2842711|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||taps/20 seconds||Standard Deviation|Mean
2842712|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Tapping at increased speed - accuracy' is the percentage of accurate taps per all taps on computer-generated fields.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of accurate taps||Standard Deviation|Mean
2842713|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Free tapping' is defined as ____. 'Free tapping accuracy' is the percentage of accurate free taps per 20 seconds(?).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of tapping accuracy||Standard Deviation|Mean
2842714|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed' is a count of the number of taps per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||taps/20 seconds||Standard Deviation|Mean
2842715|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Self-assessment' scores were -3 (Off) to +3 (dyskinetic). 'Off' time is when PD symptoms are not adequately controlled by the drug. 'Dyskinetic' time is time with involuntary muscle movement. 0 is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to 0 means improvement, everything more away from 0 means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score)."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842716|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Satisfied with function' scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842826|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
2842717|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Cramps' scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842718|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842719|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Off time' is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842720|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement, and is represented as a percentage of total time of the last __ hours.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of 'dyskinetic' time||Standard Deviation|Mean
2842721|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. On time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last __ hours."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of 'on' time||Standard Deviation|Mean
2842722|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Off time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage of 'off' time||Standard Deviation|Mean
2842735|NCT00141518|Secondary|MADRS Inability to Feel Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842723|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842724|NCT00141518|Secondary|PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842725|NCT00141518|Secondary|PDQ-39 Communication Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842726|NCT00141518|Secondary|PDQ-39 Cognition Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842727|NCT00141518|Secondary|PDQ-39 Social Support Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842728|NCT00141518|Secondary|PDQ-39 Stigma Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842729|NCT00141518|Secondary|PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842730|NCT00141518|Secondary|PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842731|NCT00141518|Secondary|PDQ-39 Mobility Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842732|NCT00141518|Secondary|Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842733|NCT00141518|Secondary|MADRS Suicidal Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842734|NCT00141518|Secondary|MADRS Pessimistic Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842827|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
2842736|NCT00141518|Secondary|MADRS Lassitude Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842737|NCT00141518|Secondary|MADRS Concentration Difficulties Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842738|NCT00141518|Secondary|MADRS Reduced Appetite Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842739|NCT00141518|Secondary|MADRS Reduced Sleep Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842740|NCT00141518|Secondary|MADRS Inner Tension Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842741|NCT00141518|Secondary|MADRS Apparent Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842742|NCT00141518|Secondary|MADRS Reported Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842743|NCT00141518|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842964|NCT00140140|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive.|up to 39 months|Treated population|||months||95% Confidence Interval|Median
2842744|NCT00141518|Secondary|MMSE Language Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842745|NCT00141518|Secondary|MMSE Recall Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842746|NCT00141518|Secondary|MMSE Attention and Calculation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842747|NCT00141518|Secondary|MMSE Registration Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842748|NCT00141518|Secondary|MMSE Orientation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842749|NCT00141518|Secondary|Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.|||units on a scale||Standard Deviation|Mean
2842750|NCT00141518|Secondary|"Schwab and England Scale: Best On Period Stage From Baseline to Month 36"|"The Schwab and England scale was used to rate the subject's best on period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). On time is when PD symptoms are well controlled by the drug."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||percentage score on a scale||Standard Deviation|Mean
2842751|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36|The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2843305|NCT00135707|Secondary|Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)|HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2842752|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36|The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842753|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36|The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842754|NCT00141518|Primary|Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010|Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36|All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.|||SEK 2010||Standard Deviation|Mean
2842755|NCT00141518|Primary|Direct Monthly Non-medical Costs Per Participant, SEK 2010|Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
2842756|NCT00141518|Primary|Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010|Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
2842757|NCT00141518|Primary|Monthly Drug Costs Per Participant, SEK 2010|Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
2842758|NCT00141518|Primary|Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010|"Total monthly costs include~Direct medical costs (inpatient care, outpatient care, and drug costs [including Duodopa cost and cost of concomitant anti-PD medication]).~Direct non-medical costs (nursing home, home help, personal assistance, informal care [from family member or friend] and transportation to inpatient, outpatient visits and nursing home).~Indirect costs (sick-leave and early retirement due to PD [applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden]).~The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK."|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants||||SEK 2010|Participants|Standard Deviation|Mean
2842759|NCT00141518|Primary|EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.|||units on a scale||Standard Deviation|Mean
2842760|NCT00141518|Primary|Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2843362|NCT00135330|Secondary|Change in Fasting Proinsulin|Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||pmol/L||Standard Error|Geometric Mean
2842761|NCT00141518|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.|||units on a scale||Standard Deviation|Mean
2842762|NCT00141453|Secondary|Reciprocal (1/Serum Creatinine) of Serum Creatinine|The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.|Randomization to 5 years|Full analysis set=566|||dL/mg/year||Inter-Quartile Range|Median
2842763|NCT00141453|Secondary|The Change in Proteinuria|The median percentage change from baseline value in urinary protein:creatinine ratio|Randomization to 5 years|Full analysis set=566|||Median percentage change in ratio|||Number
2842764|NCT00141453|Secondary|Number of Participants Experiencing Cardiovascular Composite Outcomes|Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.|Within 5 years|Full analysis set=566|||participants|||Number
2842765|NCT00141453|Primary|Renal Composite Outcomes|first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease|Randomization to 5 years|Full analysis set=566|||participants|||Number
2842766|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Tumor Response|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with tumor response.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
2842767|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Exposure|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with PD 0322991 exposure.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
2842768|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With PD 0322991 Dose|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with respect to PD 0322991 dose.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
2842769|NCT00141297|Primary|Inhibition of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) Based on Phosphorylated Retinoblastoma (p-Rb) in Tumor Tissue|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue and p-Rb levels (fold decrease) were to be reported.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.||||||
2842770|NCT00141297|Primary|Number of Participants With Best Response|Number of participants with best response. Complete response (CR): disappearance of all target and non-target lesions. Partial Response (PR): >=30% decrease in sum of longest diameter (LD) of lesions taking as reference baseline sum LD and no unequivocal progression in non-target lesions. Progressive disease (PD): >=20% increase in sum of LD of lesions taking as a reference smallest sum of the LD since treatment start, or the appearance of >=1 new lesion or unequivocal progression of existing non-target lesions. Stable disease (SD): neither shrinkage for PR nor increase for PD taking as reference smallest sum of LD since treatment start. SD was assessed following the first 2 cycles of treatment (>=2 cycles), 4 cycles of treatment (>=4 cycles), and 10 cycles of treatment (>=10 cycles). Participants may be reported in more than 1 category of SD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline up to end of treatment, assessed at C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Modified Full Analysis Set included all enrolled participants who received at least 1 dose of study medication in Cycle 1 and completed a post-treatment response assessment.|||participants|||Number
2842771|NCT00141297|Primary|Percent Dose Recovered Unchanged (Percent Ae) in Urine: Food Effect|The percent Ae is defined in Outcome Measure 44. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.||||||
2842772|NCT00141297|Primary|Percent Dose Recovered Unchanged in Urine (Percent Ae): Single Dose|Percent of dose recovered unchanged in urine over the 10 hour collection interval=100*(Ae divided by dose). Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||percentage of dose||Standard Deviation|Mean
2842773|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Food Effect|The Ae is defined in Outcome Measure 42. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.||||||
2842774|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Single Dose|Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Urine PK analysis was performed only in the MTD/RP2D groups (125 mg [21/28 Days] and 200 mg [14/21 Days]).|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||microgram (mcg)||Standard Deviation|Mean
2842775|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Food Effect|Terminal phase rate constant: absolute value of slope of a linear regression during terminal phase of natural-logarithm transformed concentration-time profile. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.||||||
2842776|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile. The mean lambda (z) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||1/hour||Standard Deviation|Mean
2842777|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 8: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.||||||
2842778|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Single Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural--logarithm transformed concentration--time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase||||||
2842828|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases|||words||Standard Error|Least Squares Mean
2842779|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Rac at Day 14/21 = AUC (0-tau) at Day 14/21 divided by AUC (0-tau) at Day 1. The mean Rac for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2842780|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 8: Multiple Dose|Rac at Day 8 = AUC (0-tau) at Day 8 divided by AUC (0-tau) at Day 1.|Hour 0 (pre-dose), 1, 2, 4, 7, 10, and 24 hours post-dose on C1D1 and C1D8|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Rac.||||||
2842781|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Food Effect|Volume of distribution: theoretical volume in which total amount of drug would need to be uniformly distributed to produce desired plasma concentration. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.||||||
2842782|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. The mean Vz/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||liter||Standard Deviation|Mean
2842783|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 8: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.||||||
2842784|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Single Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.||||||
2842785|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Food Effect|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.||||||
2842811|NCT00141297|Primary|Number of Participants With Treatment Emergent Adverse Events Categorized by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. For clinical description of nature (severity) of AEs, AEs were grades as: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; and Grade 5: death related to AE. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2842786|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. The mean CL/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||liter/hour||Standard Deviation|Mean
2842787|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 8: Multiple Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.||||||
2842788|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Single Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.||||||
2842789|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Food Effect|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).||||||
2842790|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 8: Multiple Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).||||||
2842791|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Single Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).||||||
2842792|NCT00141297|Primary|Area Under the Curve From Time Zero to End of the Dosing Interval [AUC(0 to Tau)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the curve from time zero to end of the dosing interval (24 hours) [AUC (0-tau)]. The mean AUC (0-tau) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
2842812|NCT00141297|Primary|Number of Dose-Limiting Toxicities (DLTs) Categorized as Per the Nature|DLT is defined in Outcome Measure 1. Hematologic (Grade 4 [life-threatening or disabling]) and non-hematologic (Grade 3 [severe], 4 [life-threatening and disabling], 5 [resulting in death]) DLTs are reported separately. A single participant may experience more than one DLT. Both treatment-related and treatment-unrelated DLT events were reported for this outcome measure.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||DLTs|||Number
2843363|NCT00135330|Secondary|Change in Fasting Insulin|Change in fasting insulin from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||uIU/ml||Standard Error|Geometric Mean
2842793|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Food Effect|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
2842794|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The mean AUClast for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
2842795|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 8: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng*hour/mL||Standard Deviation|Mean
2842796|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Single Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.|||nanogram*hour/milliliter (ng*hour/mL)||Standard Deviation|Mean
2842797|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.||||||
2842798|NCT00141297|Primary|Terminal Half-life (t½) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The mean t1/2 for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2842799|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 8: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.||||||
2842800|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Single Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.||||||
2842813|NCT00141297|Primary|Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose Level (RP2D)|MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was <33%. Once MTD was determined, it was defined as RP2D. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||milligram|||Number
2842829|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
2842801|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Full Range|Median
2842802|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The median Tmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Full Range|Median
2842803|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||hours||Full Range|Median
2842804|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.|||hours||Full Range|Median
2842805|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Food Effect|To determine the impact of food (specifically a high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In this crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. The first 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, the next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. The high-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of the total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2842806|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The mean Cmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2842807|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2842808|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|Pharmacokinetic (PK) analysis set included all participants from FAS who had completed PK blood sampling for at least one day.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2842809|NCT00141297|Primary|Number of Participants Who Died Due to Adverse Event on the Basis of Relatedness to Study Drug|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness [to study drug] was assessed by the investigator (Yes/No).|Baseline up to 30 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2842810|NCT00141297|Primary|Number of Participants With Treatment-Related Treatment Emergent Adverse Events|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2842951|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg|24-hour fed Leptin dose 0.01 mg/kg|1 DAY||||HR||Standard Deviation|Mean
2842952|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg|24-hour fed Leptin dose 0.3 mg/kg|1 DAY||||NG*H/ML||Standard Deviation|Mean
2842814|NCT00141297|Primary|Maximum Administered Dose (MAD)|Three new evaluable participants were to be assessed at each new dose level. The minimum time that these participants were to be followed after starting treatment was 1 cycle (28 or 21 days) before a new dose level could be opened. If none of these 3 participants experienced a DLT, the next higher dose level was to be opened on that schedule. If 1 participant developed a DLT, 3 more evaluable participants were to be enrolled at that dose level; if none of these additional 3 participants developed a DLT, the next higher dose level was to be opened on that schedule. If >=2 participants experienced a first cycle DLT at the same dose level and schedule, that dose level was to be defined as the MAD for that schedule. No additional participants were to be entered at the MAD for that dosing schedule. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||milligram|||Number
2842815|NCT00141297|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|DLT: an adverse event occurring after initiation of PD 0332991 that met any following criteria: 1) Grade 4 hematologic toxicity (platelets less than [<] 25000 per microliter (mcL), absolute neutrophil count [ANC] <500/mcL, hemoglobin [Hb] <6.5 gram per deciliter [g/dL]; 2) ANC <1000/mcL associated with documented infection or fever greater than or equal to (>=) 38.5 degrees Celsius; 3) >=Grade 3 non-hematologic treatment-related toxicity. In an asymptomatic participant, Grade 3 corrected QT (QTc) prolongation (>500 millisecond) (only if persisted with repeat testing and after correction of reversible causes [electrolyte abnormalities or hypoxia]); and 4) Inability to receive next dose of PD 0332991 within 1 week (+/-1 day) of last dose due to lack of hematologic recovery (platelets <50000/mcL, ANC <1000/mcL, and Hb <8.0 g/dL) or due to prolonged non-hematologic toxicities of >=Grade 3 severity. Occurrence of a DLT necessitated immediate interruption of scheduled study treatment.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2842816|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
2842817|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
2842818|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
2842819|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6|||Words||Standard Error|Least Squares Mean
2842820|NCT00141271|Secondary|Change in Tower of London Test at Endpoint|Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
2842821|NCT00141271|Secondary|Change in Symbol Coding at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Total Correct||Standard Error|Least Squares Mean
2842822|NCT00141271|Secondary|Change in Verbal Fluency Controlled Word Association at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
2842823|NCT00141271|Secondary|Change in Verbal Fluency in Naming Categories at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number Correct||Standard Error|Least Squares Mean
2842824|NCT00141271|Secondary|Change in Token Motor Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||Number of Tokens||Standard Error|Least Squares Mean
2842953|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg|24-hour fed Leptin dose 0.3 mg/kg|1 DAY||||NG/ML||Standard Deviation|Mean
2842830|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
2842831|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
2842832|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases|||words||Standard Error|Least Squares Mean
2842833|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases|||words||Standard Error|Least Squares Mean
2842834|NCT00141271|Secondary|Change in Verbal Memory Trial Performance Total Score at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.|Baseline to 6 Weeks LOCF|Intent to Treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||words||Standard Error|Least Squares Mean
2842835|NCT00141271|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.|Baseline to 6 weeks|ITT Population Observed cases|||score on scale||Standard Error|Least Squares Mean
2842836|NCT00141271|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.|Baseline to 6 Weeks||||score on scale||Standard Error|Least Squares Mean
2842837|NCT00141271|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed Cases|||score on scale||Standard Error|Least Squares Mean
2842838|NCT00141271|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed cases|||score on scale||Standard Error|Least Squares Mean
2842839|NCT00141271|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint|Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80|Baseline to 6 Weeks|ITT Population Observed Cases.n= 142, 137, 139; number of subjects who responded to the scale. Endpoint is LOCF endpoint among Week 1 through Week 6.|||score on scale||Standard Error|Least Squares Mean
2842840|NCT00141271|Secondary|Change in Sheehan Disability Scale (SDS) Total Score at Endpoint|Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.|Baseline to Week 6|ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 - 6; n= 128, 126, 128; number of subjects who responded to the scale.|||score on scale||Standard Error|Least Squares Mean
2842841|NCT00141271|Secondary|Response as Measured by CGI-I Score Less Than or Equal to 2|Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Week 1 through Week 6 (endpoint)|"ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.~Not all subjects answered each week."|||Participants|||Number
2842842|NCT00141271|Secondary|Change in Total Score in Hamilton Depression (HAM-D 25)|Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.|Baseline to 6 Weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||score on scale||Standard Error|Least Squares Mean
2842843|NCT00141271|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Baseline to 6 weeks|ITT population Observed Cases|||score on scale||Standard Error|Least Squares Mean
2842844|NCT00141271|Secondary|Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to 6 weeks|ITT population Observed Cases|||score on scale||Standard Error|Least Squares Mean
2842845|NCT00141271|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline to 6 weeks|ITT Population|||score on scale||Standard Error|Least Squares Mean
2842846|NCT00141271|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to 6 weeks|ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6|||score on scale||Standard Error|Least Squares Mean
2842847|NCT00141271|Secondary|Change in Hamilton Depression (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.|Baseline to 6 weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.|||score on scale||Standard Error|Least Squares Mean
2842848|NCT00141271|Secondary|Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7|Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each week."|||Participants|||Number
2842849|NCT00141271|Secondary|Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12|Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6;~Not all subjects answered each week."|||participants|||Number
2842850|NCT00141271|Secondary|Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)|Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality|Baseline, 6 Weeks LOCF|Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).|||score on scale||Standard Error|Least Squares Mean
2842851|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each Week."|||participants|||Number
2842852|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases.~Not all subjects answered at each Week"|||Participants|||Number
2842853|NCT00141271|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.|Baseline to 6 weeks|Intent to treat (ITT) population observed cases|||score on scale||Standard Error|Least Squares Mean
2842854|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 observations while on study medication were carried forward (LOCF).|||score on scale||Standard Deviation|Mean
2842855|NCT00141219|Secondary|Clinical Global Impression of Change (CGIC)|CGIC is a clinician-rated instrument that assesses the subject's overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. CGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||participants|||Number
2842856|NCT00141219|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a subject-rated instrument that measured change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. PGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||participants|||Number
2842857|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Depression (HADS-D) Score|"HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression"|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842858|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score|HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842859|NCT00141219|Secondary|Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)|EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842860|NCT00141219|Secondary|Euro Quality of Life (QOL) (EQ-5D) Utility Score|EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject's level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842861|NCT00141219|Secondary|Medical Outcome Study (MOS) Overall Sleep Problems Index|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842862|NCT00141219|Secondary|Medical Outcome Study (MOS) Somnolence|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842863|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Adequacy|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842864|NCT00141219|Secondary|Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||participants|||Number
2842865|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Quantity|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842954|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg|24-hour fed Leptin dose 0.3 mg/kg|1 DAY||||HR||Standard Deviation|Mean
2842955|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg|72-hour fasting Day 3 Leptin dose 0.3 mg/kg|3 DAY||||NG*H/ML||Standard Deviation|Mean
2842956|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg|72-hour fasting Day 3 Leptin dose 0.3 mg/kg|3 DAY||||NG/ML||Standard Deviation|Mean
2842866|NCT00141219|Secondary|Medical Outcome Study (MOS) Awaken Short of Breath or Headache|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842867|NCT00141219|Secondary|Medical Outcome Study (MOS) Snoring Score|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842868|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Disturbance|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.|||score on scale||95% Confidence Interval|Least Squares Mean
2842869|NCT00141219|Secondary|Mean Sleep Score as Computed by DSIS.|DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.|Weeks 1 to 8|ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n = (pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2842870|NCT00141219|Secondary|Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).|DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily sleep interference scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||score on scale||95% Confidence Interval|Least Squares Mean
2842871|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Subjects without any post-baseline daily pain scores would have no DAAC; missing DAACs were not imputed.|||score on scale||95% Confidence Interval|Least Squares Mean
2842872|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score|DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n= (pregabalin, placebo).|||score on scale||Standard Error|Least Squares Mean
2842873|NCT00141219|Other Pre-specified|Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|"Evaluable (EVAL) Population: Subset of ITT subjects with ≥4 daily pain diaries in the 7 days before Visit 2 (randomization) with average score ≥4; ≥14 days of treatment; ≥14 days of DB daily pain diaries; not withdrawn due to Protocol violation or Did not meet entrance criteria; not previously participated in the study."|||score on scale||95% Confidence Interval|Least Squares Mean
2842874|NCT00141219|Primary|Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||score on scale||95% Confidence Interval|Least Squares Mean
2842875|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.|Endpoint- Week 8 or Early Discontination|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||participants|||Number
2842876|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.|||participants|||Number
2842877|NCT00141115|Secondary|Percent of Drinking Days|daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back|assessed daily, reported for baseline 28 days compared to last 28 days of study participation||||percentage of days||Standard Deviation|Mean
2842878|NCT00141115|Primary|Participants Who Reported Reductions in Alcohol Consumption|Number of participants who reduced drinking during the trial|over 9 weeks of study or length of participation|Number of participants who were drinking less at the end of the study compared to the beginning.|||Participants|||Count of Participants
2842879|NCT00141102|Other Pre-specified|Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.|||participants|||Number
2842880|NCT00141102|Other Pre-specified|Number of Subjects Alive at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.|||participants|||Number
2842881|NCT00141102|Secondary|Change From Baseline in C-Reactive Protein to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||mg/dL||Standard Error|Least Squares Mean
2842882|NCT00141102|Secondary|Change From Baseline in Ferretin to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||ug/dL||Standard Error|Least Squares Mean
2842883|NCT00141102|Secondary|Change From Baseline in Iron Binding Capacity to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||microgram (ug)/dL||Standard Error|Least Squares Mean
2842884|NCT00141102|Secondary|Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||IU/L||Standard Error|Least Squares Mean
2842885|NCT00141102|Secondary|Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)|GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.|6 month treatment duration|Safety population. Number of participants analyzed = number of subjects with analyzable data.|||participants|||Number
2842886|NCT00141102|Secondary|Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin|A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.|6 month treatment duration|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.|||participants|||Number
2842887|NCT00141102|Secondary|Change From Baseline in Hematocrit at Month 6/ET||Month 6/ET|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.|||percent||Standard Error|Least Squares Mean
2842888|NCT00141102|Secondary|Change From Baseline in Hemoglobin at Month 6/ET||Month 6/ET|Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.|||grams (g)/deciliter (dL)||Standard Error|Least Squares Mean
2842889|NCT00141102|Secondary|Number of Subjects Withdrawn Due to GI Adverse Events (AEs)|"GI AEs were defined using MedDRA SOC Gastrointestinal Disorders but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions."|6 month treatment duration|ITT|||participants|||Number
2842890|NCT00141102|Secondary|Number of Subjects With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to Gastrointestinal Signs and Symptoms."|6 month treatment duration|ITT|||participants|||Number
2842891|NCT00141102|Secondary|Number of Subjects With CSULGIEs by History of GD Ulceration|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|ITT. n = number of subjects who had history or no history of GD ulceration.|||participants|||Number
2842892|NCT00141102|Secondary|Number of Subjects With SUs|Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT.|||participants|||Number
2842893|NCT00141102|Secondary|Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)|"Subjects rated response to question: Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today? using a 1 to 5 grading scale where 1=very good and 5=very poor."|Month 6/Early Termination (ET)|ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.|||scores on a scale||Standard Error|Least Squares Mean
2842957|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg|72-hour fasting Day 3 Leptin dose 0.3 mg/kg|3 DAY||||HR||Standard Deviation|Mean
2842894|NCT00141102|Secondary|Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)|CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.|||participants|||Number
2842895|NCT00141102|Primary|Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.|||participants|||Number
2842896|NCT00141037|Primary|Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation|"Biopsy-proven acute renal (kidney) rejection [1, 2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Up to one year post kidney transplantation procedure|All Enrolled Subjects|||Rejection Events||95% Confidence Interval|Number
2842897|NCT00141037|Primary|The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation|Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free|One year post kidney transplantation procedure|All Enrolled Subjects|||Standard Deviation Score (SDS)||Standard Deviation|Mean
2842898|NCT00140842|Secondary|Visceral Adipose Tissue|Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)|Baseline|The analysis was completed on the 30 participants as per protocol|||grams||Standard Deviation|Mean
2842899|NCT00140842|Primary|Peak Growth Hormone (GH) on the GH Stimulation Test|Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.|Baseline|This was a cross-sectional study to compare differences in growth hormone (GH) secretory status in relation to body composition in obese versus normal-weight girls. This was a pilot study and the analysis was performed using a Student t-test to compare means across groups|||ng/ml||Standard Deviation|Mean
2842900|NCT00140621|Primary|Change From Baseline in LVM at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.|||gm||95% Confidence Interval|Least Squares Mean
2842901|NCT00140621|Primary|Percent Change From Baseline in Left Ventricular Mass (LVM) at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.|||percent change||95% Confidence Interval|Least Squares Mean
2842902|NCT00140621|Secondary|Change From Baseline in Short Form (36) Health Survey (SF-36) Scores at Week 156|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 156|EEP.|||units on a scale||Standard Deviation|Mean
2842903|NCT00140621|Secondary|Percent Change From Baseline in GL-3 Plasma Levels at Week 156||Baseline to Week 156|EEP.|||percent change||95% Confidence Interval|Least Squares Mean
2842904|NCT00140621|Secondary|Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test|Overall cardiac function assessment was assessed by tests (echocardiogram,cardiac catheterization (optional),electrocardiogram,B-type natriuretic peptide [BNP]), clinical symptoms (subjective symptoms) and the New York Heart Association (NYHA) cardiac functional classification.Overall assessment of cardiac function was assessed based on the evaluation items including interventricular septum thickness, left ventricular posterior wall thickness, left ventricular mass, clinical function tests and clinical symptoms. A subject was considered to be Improved: if Improved in 2 items or more, Unchanged: Improved in one item and unchanged in 2 items or unchanged in all 3 items, Aggravated: Aggravated in one item or more.|Baseline to Week 156|EEP.|||participants|||Number
2842905|NCT00140621|Primary|Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.|||mm||95% Confidence Interval|Least Squares Mean
2842906|NCT00140621|Primary|Percent Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.|||percent change||95% Confidence Interval|Least Squares Mean
2842907|NCT00140556|Secondary|Failure Free Survival||3 yrs|||||||
2842908|NCT00140556|Secondary|Local Regional Control||1 yr following chemoradiation|||||||
2842909|NCT00140556|Primary|Tumor Resolution|Complete response (resolution) of tumor on clinical exam.|Within 30 days of completing RT|2 participants had occult primaries, thus were not included in clinical complete response|||Participants|||Number
2842958|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg|72-hour fasting Day 3 Leptin dose 0.1 mg/kg|3 DAY||||NG*H/ML||Standard Deviation|Mean
2842910|NCT00140426|Primary|Body Image Software (BIS) - Difference Limen (DL)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.|||units on a scale||Standard Deviation|Mean
2842911|NCT00140426|Primary|Body Image Software (BIS) - Point of Subjective Equality (PSE)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.|||units on a scale||Standard Deviation|Mean
2842912|NCT00140426|Primary|Body Image Software (BIS): Average Desired Thinness|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image. The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their desired image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales."|monthly|Many patients did not complete this outcome measurement. Change from baseline to end of study were compared between arms.|||units on a scale||Standard Deviation|Mean
2842913|NCT00140426|Primary|Body Image Software (BIS): Average Distortion|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to adjust their image to how they see themselves right now, this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of how they see themselves right now"|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.|||units on a scale||Standard Deviation|Mean
2842914|NCT00140426|Primary|Color A Person Test (CAPT)|"Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation.~Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction.~Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly||||units on a scale||Standard Deviation|Mean
2842915|NCT00140426|Secondary|Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities.|0 - 18 weeks||||weeks||Standard Error|Mean
2842916|NCT00140426|Secondary|Change in Prolactin Levels|Prolactin serum blood levels, measured in nanograms / ml|week 0 and week 7||||ng/ml||Standard Deviation|Mean
2842917|NCT00140426|Secondary|Change in Leptin Levels|Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml).|Week 0 and week 7||||ng/ml||Standard Deviation|Mean
2842918|NCT00140426|Secondary|Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)|"The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms.~Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety~Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly to study end point||||units on a scale||Standard Deviation|Mean
2842919|NCT00140426|Secondary|Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks.|weekly||||weeks||Standard Error|Mean
2842920|NCT00140426|Primary|Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)|"The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28.~Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc.~EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base.~Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program."|weekly up to study endpoint: reaching target weight and maintaining for 1 month|2 patients in the placebo group were treated as inpatients and had no EOE data.|||hazard ratio||95% Confidence Interval|Number
2842959|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg|72-hour fasting Day 3 Leptin dose 0.1 mg/kg|3 DAY||||NG/ML||Standard Deviation|Mean
2842921|NCT00140426|Primary|Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)|"change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD).~Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly|1 risperidone subject was missing data for BD at this data point.|||units on a scale||Standard Deviation|Mean
2842922|NCT00140426|Primary|Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)|"Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness.~The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as usually , often, sometimes, rarely or never. Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|month||||units on a scale||Standard Deviation|Mean
2842923|NCT00140413|Primary|Change in Anthropometric Measures Over Time|Primary outcome measures included change in stature, weight, BMI, and weight-for-stature z-scores over the course of the study. Z-score indicates how many standard deviations an element is from the mean. It is calculated as z = (x - µ) σ, where µ is the mean of the population, and σ is the standard deviation of the population. A positive z-score indicates a datum above the mean, while a negative z-score indicates a datum below the mean. All z-scores were obtained using Epi Info ™ 3.5.4. (Centers for Disease Control, Atlanta, GA).|Baseline and 36 months||||Z-score||Inter-Quartile Range|Median
2842924|NCT00140244|Secondary|Hepatic Fat Content||At the end of each two month intervention||||percentage of liver volume||Standard Error|Mean
2842925|NCT00140244|Secondary|Interleukin-6 (IL-6) Levels||At the end of each two month intervention||||pg/ml||Standard Error|Mean
2842926|NCT00140244|Secondary|CD4+ Lymphocytes||At the end of each two month intervention||||cells/mcl||Standard Error|Mean
2842927|NCT00140244|Secondary|Viral Load||At the end of each two month intervention||||copies/ml||Standard Error|Mean
2842928|NCT00140244|Secondary|Lean Body Mass|lean body mass|At the end of each two month intervention||||kg||Standard Error|Mean
2842929|NCT00140244|Secondary|Insulin Levels||At the end of each two month intervention||||mcIU/ml||Standard Error|Mean
2842930|NCT00140244|Secondary|Fibrinogen|Fibrinogen|At the end of each two month intervention||||mg/dL||Standard Error|Mean
2842931|NCT00140244|Secondary|Blood Pressure|percent change in mean blood pressure|At the end of each two month intervention||||percentage change of mean blood pressure||Standard Error|Least Squares Mean
2842932|NCT00140244|Secondary|Free Fatty Acid (FFA) Levels||At the end of each two month intervention||||mEq/liter||Standard Error|Mean
2842933|NCT00140244|Secondary|Low Density Lipoprotein (LDL) Cholesterol Levels||At the end of each two month intervention||||mg/dl||Standard Error|Mean
2842934|NCT00140244|Secondary|Glycemia (as Assessed by Fasting Glucose)||At the end of each two month intervention||||mg/dl||Standard Error|Mean
2842935|NCT00140244|Secondary|Insulin Resistance (as Assessed by HOMA-IR)||At the end of each two month intervention||||units on a scale||Standard Error|Mean
2842936|NCT00140244|Primary|Serum Lipid Levels||At the end of each two month intervention||||mg/dl||Standard Error|Mean
2842937|NCT00140231|Secondary|Autonomic Function|aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1|four days||||pg/ml||Standard Error|Mean
2842938|NCT00140231|Secondary|(RMR)|Resting Metabolic rate using calorimetry|four days||||kcal/d||Standard Deviation|Mean
2842939|NCT00140231|Secondary|%Fat Mass||four days||||fat%||Standard Deviation|Mean
2842940|NCT00140231|Primary|Immune Function CD3 Count||4 days||||cells/ul||Standard Error|Mean
2842941|NCT00140231|Primary|ACTH Mean Level|Response of ACTH to leptin administration in fed and fasting state from baseline was measured|4 days||||pg/ml||Standard Error|Mean
2842942|NCT00140231|Primary|Cortisol||four days||||ug/dl||Standard Deviation|Mean
2842943|NCT00140205|Secondary|Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)|Data were collected neither in Fed nor in Fasting state for the different doses of leptin|day 3 of fasting and day 1 of fed state|||||||
2842944|NCT00140205|Secondary|Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)|Data were collected neither in Fed nor in Fasting state for the different doses of leptin|1 DAY or DAY 3|||||||
2842945|NCT00140205|Secondary|Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)|Data were collected neither in Fed nor in Fasting state for the different doses of leptin|1 DAY or DAY 3|||||||
2842946|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg|24-hour fed Leptin dose 0.1 mg/kg|1 DAY||||NG*H/ML||Standard Deviation|Mean
2842947|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg|24-hour fed Leptin dose 0.1 mg/kg|1 DAY||||NG/ML||Standard Deviation|Mean
2842948|NCT00140205|Primary|Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg|24-hour fed Leptin dose 0.1 mg/kg|1 DAY||||HR||Standard Deviation|Mean
2842949|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg|24-hour fed Leptin dose 0.01 mg/kg|1 DAY||||NG*H/ML||Standard Deviation|Mean
2842950|NCT00140205|Primary|Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg|24-hour fed Leptin dose 0.01 mg/kg|1 DAY||||NG/ML||Standard Deviation|Mean
2842965|NCT00140140|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|"PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP."|up to month 30|Treated population of participants who had disease progression or who died|||months||95% Confidence Interval|Median
2842966|NCT00140140|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated participants who had a response|||months||95% Confidence Interval|Median
2842967|NCT00140140|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated population of participants with disease progression|||months||95% Confidence Interval|Median
2842968|NCT00140140|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|up to month 30|Treated population|||percentage of participants|||Number
2842969|NCT00140140|Primary|Nadir Measurement for Hemoglobin (Hgb)|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population|||g/L||Standard Deviation|Mean
2842970|NCT00140140|Primary|Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population|||10^9/L||Standard Deviation|Mean
2842971|NCT00140140|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3.~ANC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L~WBC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L~Platelets:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L~Hemoglobin:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100 g/L ; Grade 2 = <100 - 80 g/L; Grade 3 = <80 - 65 g/L; Grade 4 = <65 g/L"|up to week 129 (longest treatment)|Treated population|||participants|||Number
2842972|NCT00140140|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 129|Treated population|||percentage of participants|||Number
2842973|NCT00140140|Primary|Participants With Dose Limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:~requirement of a dose adjustment during the first 4 weeks~a dose delay of >3 weeks during the first 4 weeks Grade 3 or greater toxicities attributed to the use of Herceptin were not considered dose-limiting toxicities.~The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs."|up to month 1|Treated population|||participants|||Number
2842974|NCT00140140|Primary|Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation.~Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|up to month 30|Treated population|||percentage of participants||95% Confidence Interval|Number
2842975|NCT00139997|Secondary|SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly following randomization|These participants are analyzed ITT- last observation carried forward.|||units on a scale||Standard Deviation|Mean
2842976|NCT00139997|Primary|Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.~Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization"|Week 4|These participants are analyzed ITT- last observation carried forward.|||Percentage of SIGH SAD||Standard Deviation|Mean
2842977|NCT00139776|Other Pre-specified|Serious Adverse Events in Open Label run-in Period|Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily|2 weeks prior to double blind dosing|1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.|||participants|||Number
2842978|NCT00139776|Other Pre-specified|Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments|SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)"|||scores on a scale||Standard Deviation|Mean
2842979|NCT00139776|Other Pre-specified|Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep|Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||participants|||Number
2842980|NCT00139776|Secondary|Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424"|||scores on a scale * weeks||Standard Deviation|Mean
2842981|NCT00139776|Other Pre-specified|Change in Medical Outcomes Study Sleep Scale - All Assessments|Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)|||scores on a scale||Standard Deviation|Mean
2842982|NCT00139776|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424|||scores on a scale||Standard Error|Least Squares Mean
2842983|NCT00139776|Secondary|Days on Flare Medication|Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects who did not take flare medication were calculated as 0 and included in the analysis.~Number of subjects taking flare medication: continuous use n=282; intermittent use n=339."|||days on medication per month per subject||Standard Deviation|Mean
2842984|NCT00139776|Secondary|Proportion of Days on Rescue Medication|Days on rescue medication divided by number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.~Subjects who did not take rescue medication were calculated as 0 and included in the analysis."|||proportion of days||Standard Deviation|Mean
2842985|NCT00139776|Secondary|Total Rescue Medication Taken (Mean)|Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis.~Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239."|||mg taken per month per participant||Standard Deviation|Mean
2842986|NCT00139776|Secondary|Physician's Global Assessment of Arthritis at Final Visit|Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||participants|||Number
2842987|NCT00139776|Secondary|Patient's Global Assessment of Arthritis|"Participant's response to question Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today? on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III."|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."|||scores on a scale * weeks||Standard Error|Least Squares Mean
2842988|NCT00139776|Secondary|Arthritis Pain Numerical Rating Scale (NRS)|Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."|||scores on a scale * weeks||Standard Error|Least Squares Mean
2842989|NCT00139776|Secondary|Proportion of Days in Osteoarthritis (OA) Flare|Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)||||proportion of days in OA flare||Standard Deviation|Mean
2842990|NCT00139776|Secondary|Proportion of Days Free From Osteoarthritis (OA) Flare|Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||proportion of days free from OA flare||Standard Deviation|Mean
2842991|NCT00139776|Secondary|Time to Occurrence of First Osteoarthritis (OA) Flare|Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.|||days||95% Confidence Interval|Median
2842992|NCT00139776|Primary|Number of Flare Events Per Time of Exposure to Study Medication|Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication|||flare events per month||Standard Deviation|Mean
2842993|NCT00139737|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Baseline up to 72 months|Safety Analysis Set = All subjects who took at least 1 dose of study drug|||Participants|||Number
2842994|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||mL/min/mmHg||Standard Deviation|Mean
2842995|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.|Baseline through Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS): all subjects who were randomized, had a baseline post-albuterol pulmonary function test (PFT) measurement, and had at least two post-baseline, post-albuterol PFT measurements. LOCF: last observation carried forward.|||liters||Standard Deviation|Mean
2842996|NCT00139659|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS). Due the small number of events severe hypoglycemic event rates were assessed per 100 months.|||Number of events/100 subject-months.|||Number
2842997|NCT00139659|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS)|||events / subject-months|||Number
2843364|NCT00135330|Secondary|Change in Fasting C-peptide|Change in fasting C-peptide from baseline to week 20.|Week 20|Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.||||||
2842998|NCT00139659|Secondary|Lipids: Median Change From Baseline to Last Observation|Lipids: median changes (milligrams per deciliter [mg/dL]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined.|Baseline to Last Observation|Primary analysis set (PAS); median change from Baseline to last observation. Last observation was defined as last observation while on study drug or during the lag. Full range (-999 to 999) was not calculated.|||mg/dL|||Number
2842999|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg/kg, units/kg||Standard Deviation|Mean
2843000|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Average Total Daily Insulin Dose: short-acting insulin (milligrams [mg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg, units||Standard Deviation|Mean
2843001|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|"Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg."|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg/kg, units/kg||Standard Deviation|Mean
2843002|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|"Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg. Subcutaneous Insulin reported in units."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)|||mg, units||Standard Deviation|Mean
2843003|NCT00139659|Secondary|Body Weight: Mean Baseline and Change From Baseline|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS)|||kilograms||Standard Deviation|Mean
2843004|NCT00139659|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (milligrams per deciliter [mg/dL]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS); Last Observation Carried Forward: if the end of study value was missing the last available observation for that subject was used..|||mg/dL||Standard Deviation|Mean
2843005|NCT00139659|Secondary|Glycosylated Hemoglobin (HbA1c)|Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS)|||percent||Standard Deviation|Mean
2843006|NCT00139659|Secondary|Transition Dyspnea Index (TDI): Change in Total Score|Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).|Week 4, Week 12, Week 26, Week 39, Week 52|Full analysis set (FAS)|||scores on scale||Standard Deviation|Mean
2843007|NCT00139659|Secondary|Baseline Dyspnea Index (BDI)|Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).|run-in period|Full analysis set (FAS)|||scores on scale||Standard Deviation|Mean
2843008|NCT00139659|Secondary|Asthma Control as Measured by the Asthma Control Questionnaire©|Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (>95% predicted) to 6 (<50% predicted). Overall score = mean of questions 1 - 7.|Baseline, Weeks 4, 12, 26, 39, 52|FAS; abbreviations: Eval = evaluations, BL = Baseline.|||scores on scale||Standard Deviation|Mean
2843009|NCT00139659|Primary|Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS).|||ml/min/mmHg/yr||Standard Error|Mean
2843010|NCT00139659|Secondary|Number of Systemic Corticosteroid Rescues|Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = >=2 consecutive days between the end of one event and the start of another event.|Baseline through Week 52|Full analysis set (FAS); number of subjects with systemic corticosteroid rescues = inhaled insulin: 12, and subcutaneous insulin: 14. Due to inconsistencies in data entry, the numbers of systemic corticosteroid rescues were not considered entirely accurate.|||systemic corticosteriod rescues|||Number
2843577|NCT00132132|Primary|Change in BMI (Body Mass Index)||Baseline, 12-15 months|Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment|||kg/m^2||95% Confidence Interval|Mean
2843011|NCT00139659|Secondary|Incidence of Severe Asthma Exacerbations|Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months * 100.|0 to 1 Week to > 12 Months|Full analysis set (FAS); due to inconsistencies in data entry for systemic steroids, the protocol definition for severe asthma exacerbations, which was based on systemic corticosteroid use for asthma, could not be accurately assessed. Due the small number of events the incidence of severe asthma exacerbations was assessed per 100 months.|||events/subject months*100|||Number
2843012|NCT00139659|Secondary|Incidence of Non-severe Asthma Exacerbations|Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) <80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 <60% of Baseline at any time. Percent of Baseline = 100*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.|0 to 1 week to > 12 months|FAS; review of source data for this endpoint showed excessive data variability for home-monitored FEV1 with outliers ranging from 0.01 to >100, and many subjects with random peaks and dips of 100% or more of their baseline. It is unlikely that the protocol definition is robust enough to provide real information about exacerbation frequencies.|||events/subject-months|||Number
2843013|NCT00139659|Secondary|Mean Weekly Asthma Symptom Scores|Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).|Baseline through end of study|Data for mean weekly asthma symptom scores were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.|||scores on scale||Standard Deviation|Mean
2843014|NCT00139659|Secondary|Step Classification of Asthma Severity by Medication Usage|Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for step classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.|||subjects|||Number
2843015|NCT00139659|Secondary|Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage|All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for the number of step-up and step-down changes in classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.|||subjects|||Number
2843016|NCT00139659|Secondary|Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)|All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.|Daily: Baseline to end of study|Mean weekly number of puffs of albuterol was not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.|||number of puffs||Standard Deviation|Mean
2843017|NCT00139659|Secondary|Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)|Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.|Week -3 through Week 52|Mean weekly morning and evening peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.|||liters||Standard Deviation|Mean
2843018|NCT00139659|Secondary|Methacholine Challenge|Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.|1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)|There were no methacholine challenges performed in subjects using inhaled insulin due to protocol-defined exclusion criteria for methacholine challenge testing, and methacholine provocative concentration [of methacholine] causing a 20% fall in FEV1 (PC20) data were not analyzed.|||liters||Standard Deviation|Mean
2843031|NCT00139477|Primary|Change From Baseline in Interleukin 6 (IL-6) at 6 Months|Value at 6 months minus value at baseline. IL-6 is a pro-inflammatory cytokine thought to produce a state of low-grade inflammation in obese individuals. IL-6 stimulates hepatic production of C-reactive protein (CRP), an acute phase protein which is a sensitive marker for systemic inflammation. IL-6 was measured by enzyme-linked immunosorbent assay (ELISA; R&D Systems, Minneapolis, MN, USA).|Baseline and 6 months||||pg/mL||Inter-Quartile Range|Median
2843019|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.|Baseline, Week 9, Week 51|Full analysis set (FAS)|||ml/min/mmHg||Standard Deviation|Mean
2843020|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value *100%.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||percent||Standard Deviation|Mean
2843021|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.|Baseline, Week 9, Week 51|Full analysis set (FAS)|||liters||Standard Deviation|Mean
2843022|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value *100%.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||percentage of FEV1||Standard Deviation|Mean
2843023|NCT00139659|Secondary|Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol|Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52|Full analysis set (FAS)|||percent change in FEV1||Standard Deviation|Mean
2843024|NCT00139659|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||liters||Standard Deviation|Mean
2843025|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||ml/min/mmHg||Standard Deviation|Mean
2843026|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward|Full analysis set (FAS); LOCF: last observation carried forward.|||liters||Standard Deviation|Mean
2843027|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||ml/min/mmHg||Standard Deviation|Mean
2843028|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.|||liters||Standard Error|Mean
2843029|NCT00139659|Primary|Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for forced expiratory volume in 1 second (FEV1) (liters per year [L/yr]) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration.|||L/yr||Standard Error|Mean
2843030|NCT00139477|Primary|Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months|Value at 6 months minus value at baseline. PAI-1 is the primary physiological inhibitor of fibrinolysis and proteolysis. High PAI-1 levels have been linked to thrombosis and fibrosis, insulin resistance and obesity. PAI-1 was measured by ELISA (American Diagnostica, Stamford, CT, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group and 1 Subject in the Diet/Exercise, then Diet/Exercise plus Metformin (Pubertal) Group did not have a PAI-1 level available for analysis."|||ng/ML||Inter-Quartile Range|Median
2843032|NCT00139477|Primary|Change From Baseline in Fibrinogen at 6 Months|Value at 6 months minus value at baseline. Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. Fibrinogen concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have a Fibrinogen level available for analysis."|||mg/dL||Inter-Quartile Range|Median
2843033|NCT00139477|Primary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months|Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have an hsCRP level available for analysis."|||mg/dL||Inter-Quartile Range|Median
2843034|NCT00139477|Primary|Protocol #1: Serum Marker Levels Between Obese and Lean Children|This outcome measure is from Protocol #1 (a cross-sectional study); results are not posted.|Screening Visit|||||||
2843035|NCT00139399|Secondary|Blood Flow Volume|Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.|5 years|27 of the patients who returned for the 5 year angiogram were eligible for invasive measurement of blood flow.|||ml/min||Standard Deviation|Mean
2843036|NCT00139399|Primary|Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)|Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.|5 year follow-up|Intracoronary physiology investigations (diameter and intracoronary Doppler blood flow velocity measurements) were carried out in a subgroup of patients (n=27).|||mm||Standard Deviation|Mean
2843037|NCT00139399|Primary|Patency Rates|Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography|5 years|103 of the patients randomized at the time of surgery agreed to return for the 5-year follow-up angiogram.|||Participants|||Count of Participants
2843038|NCT00138671|Secondary|Severe Hypoglcyemic Event Rates|An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events / 100 subject-months|||Number
2843039|NCT00138671|Secondary|Hypoglycemic Event Rates|A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events / subject-month|||Number
2843040|NCT00138671|Secondary|Lipids|Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.|Duration of the study||||mg/dL|||Number
2843041|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mg/kg, Units/kg||Standard Deviation|Mean
2843042|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)|Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||Units/kg||Standard Deviation|Mean
2843043|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mg, Units||Standard Deviation|Mean
2843044|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)|Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||Units||Standard Deviation|Mean
2843072|NCT00138645|Primary|Body Weight Loss (kg and Percent) at Months 3 and 6||April 2005 to May 2006|||||||
2843073|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline and Day 35|PK parameter change from baseline to day 35 for AUC4 and AUC12|Baseline through day 35||||hr*mg/L||Full Range|Median
2843045|NCT00138671|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52|FAS, HbA1c=randomized subjects with >=1 study drug dose, baseline and >=1 post-baseline HbA1c measurement. Last Observation Carried Forward (LOCF) method used. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin. Week 11 and 50 visits were part of the methacholine substudy and were not required visits for all subjects.|||kg||Standard Deviation|Mean
2843046|NCT00138671|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mg/dL||Standard Deviation|Mean
2843047|NCT00138671|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, and 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||percent||Standard Deviation|Mean
2843048|NCT00138671|Secondary|Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires|The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.|Duration of the study||||grade|||Number
2843049|NCT00138671|Secondary|Incidence of Severe COPD Exacerbations|Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events/subject-month (crude event rate)|||Number
2843050|NCT00138671|Secondary|Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||events/subject-month (crude event rate)|||Number
2843051|NCT00138671|Secondary|Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used|All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.|Duration of the study||||puffs|||Number
2843052|NCT00138671|Secondary|Methacholine PC20|Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.|Duration of the study||||mg/mL|||Number
2843053|NCT00138671|Secondary|Insulin Dose Responsiveness for DLco|DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had a FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mL/min/mmHg||Standard Deviation|Mean
2843054|NCT00138671|Secondary|Insulin Dose Responsiveness for FEV1|FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||L||Standard Deviation|Mean
2843055|NCT00138671|Secondary|Bronchodilator Responsiveness as Determined by the Change in FEV1|Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||percent change||Standard Deviation|Mean
2843056|NCT00138671|Secondary|Other PFTs (Besides FEV1 and DLco)|Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.|Duration of the study||||mL|||Number
2843074|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline Through Day 35|PK parameter change from baseline to day 35 for Cmax.|Baseline through day 35||||ng/mL||Full Range|Median
2843057|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)|DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||mL/min/mmHg||Standard Deviation|Mean
2843058|NCT00138671|Secondary|Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)|Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study||||mL/min/mmHg|||Number
2843059|NCT00138671|Secondary|Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)|Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study||||L|||Number
2843060|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|Full Analysis Set (FAS), FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.|||L||Standard Deviation|Mean
2843061|NCT00138658|Secondary|AUC-0-last|AUC-0-last is the area under the plasma concentration time curve from time 0 to the last last time point (23.5 hrs)|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011|||ng*h/mL||Standard Deviation|Mean
2843062|NCT00138658|Secondary|t1/2 of OGX-011|Plasma half life of OGX-011|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011|||hours||Standard Deviation|Mean
2843063|NCT00138658|Primary|Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen|"Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR).~The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles.~CR: disappearance of clinical/radiological evidence of tumor.~PR: >= 30% decrease in the sum of the longest diameter of target lesions.~SD: did not fulfill the criteria for CR or PR but not progressive disease."|Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.|The efficacy analysis included all 81 subjects that received at least one dose of OGX-011. Of the 25 subjects with CR or PR, 21 subjects had a confirmed response. The other 4 patients did not have confirmatory scans (n=3) or discontinued treatment (N=1).|||percentage of participants|||Number
2843064|NCT00138658|Secondary|Cmax of OGX-011|Cmax is a plasma pharmacokinetic parameter that is defined as the maximum observed concentration of drug substance in plasma.|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011|||ng/mL||Standard Deviation|Mean
2843065|NCT00138658|Secondary|Effect of OGX-011 on Serum Clusterin Levels|To measure the effect of OGX-011 on serum clusterin levels. The drug substance, OGX-011, is an antisense product designed to bind to clusterin mRNA, resulting in the inhibition of the production of human clusterin protein. Therefore, serum clusterin levels were expected to decrease.|Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1|55 evaluable subjects had baseline value and at least one post-baseline serum clusterin assessment.|||µg/mL||Standard Deviation|Mean
2843066|NCT00138658|Secondary|Overall Survival|Overall survival was defined as time from date of first treatment with OGX-011 to the date of death from any cause. Overall survival was censored at date of last contact for subjects who were still alive at end of study.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of subjects who died (n=70); n=11 subjects were censored at end of study (10 were alive and 1 was lost to follow up)|||months||95% Confidence Interval|Median
2843067|NCT00138658|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as time from first treatment with OGX-011 to documented evidence of disease progression or date of death. For subjects without disease progression based on RECIST who initiated subsequent anti-cancer therapy, date of progression was defined as date of initiating new cancer treatment. PFS was censored as of the date of first OGX-011 dose for subjects who failed to return for assessments after screening. For subjects who were still alive and without progressive disease at the time of data cut-off, PFS was censored at date of last disease assessment.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of patients who progressed or died (n=75); data for 6 patients were censored. (PFS was censored at the date of the first dose of OGX-011 for subjects who failed to return for any disease assessments after screening.)|||months||95% Confidence Interval|Median
2843068|NCT00138645|Primary|Percent Change in Body Weight (Completers).|Percent change in body weight from baseline to week 24(completers).|24 weeks||||change in percent:baseline body weight||Standard Error|Least Squares Mean
2843069|NCT00138645|Secondary|Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6||April 2005 to May 2006|||||||
2843070|NCT00138645|Secondary|Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6||April 2005 to May 2006|||||||
2843071|NCT00138645|Secondary|Change in Body Composition at Months 3 and 6||April 2005 to May 2006|||||||
2843075|NCT00138424|Primary|Number of Subjects Experiencing at Least One Laboratory Abnormality|The following lab values assessed during the 49 days of subject involvement were the following: hemoglobin, hematocrit, platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), serum creatinine, calcium, phosphorous, serum albumin, glucose, uric acid, magnesium, total protein, total bilirubin, alanine aminotransferase (ALT), asparate aminotransferase (AST) and alkaline phosphate. The outcome measure is the number of subjects experiencing at least 1 grade 1 (mild) or higher event.|Baseline through day 49||||Participants|||Number
2843076|NCT00138424|Primary|Changes Observed in the Physical Examination: Heart Rate (Per Minute)|The heart rate is the number of heart beats per minute. The outcome measure is the change from baseline heart rate to day 49 heart rate.|Baseline through day 49.|Subject's whose heart rate was measured at baseline and day 49 visit|||Change in Beats per Minute||Full Range|Median
2843077|NCT00138424|Primary|Changes Observed in the Physical Examination: Body Temperature (Fahrenheit)|The temperature is a measure of body temperature in fahrenheit (F). The measure is a change between baseline temperature and day 49 temperature.|Baseline through day 49.|Subject's last visit minus baseline visit|||Temperature (F)||Full Range|Median
2843078|NCT00138424|Secondary|Allograft Rejection.|Allograft rejection is the number of subjects that rejected their kidney by the end of the study.|Day 49.|Number of rejections|||Participants|||Number
2843079|NCT00138424|Secondary|Allograft Function at the Completion of the Study|"Glomerular filtration rate (GFR) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the tiny filters in the kidneys, called glomeruli, each minute. The normal health GFR is about 90 - 120 mL/min/1.73 m2. Older people will have lower normal GFR levels, because GFR decreases with age.~Abnormal Results are expected to be below 60 mL/min/1.73 m2 for 3 or more months are a sign of chronic kidney disease. A GFR result below 15 mL/min/1.73 m2 may be a sign of kidney failure."|Day 49.|subjects that had GFR at each visit last visit|||mL/min/1.73 m2||Full Range|Median
2843080|NCT00138424|Primary|Changes Observed in the Physical Examination: Blood Pressure (mm/hg)|"Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. Blood pressure usually refers to the arterial pressure of the systemic circulation. During each heartbeat, blood pressure varies between a maximum (systolic) and a minimum (diastolic) pressure. The measure is the difference between the baseline systolic and baseline diastolic value with the day 49 systolic and day 49 diastolic value."|Baseline through day 49.||||mm Hg||Full Range|Median
2843081|NCT00138424|Primary|Changes Observed in the Physical Examination : Respiratory Rate (Per Minute)|Respiratory rate is the number of breaths per minute.|Baseline through day 49.|subjects whose respiratory rate was measured at baseline visit and at day 49 visit.|||Change in Breaths per Minute||Full Range|Median
2843082|NCT00138424|Primary|Number of Related Adverse Events|"The investigator's assessment of an AE's relationship to study drug is part of the documentation process. All adverse events had their relationship to study product assessed using the following terms: associated (related)or not associated (not related). To help assess, the following guidelines were used.~Associated - There was a known temporal relationship and/or, if re-challenge was done, the event abates with de-challenge and reappears with re-challenge and/or the event was known to occur in association study product or with a product in a similar class of study products~Not Associated -the AE was completely independent of study product administration; and/or evidence existed that the event was definitely related to another etiology."|Baseline through day 49.|Number of Related Events|||Events|||Number
2843083|NCT00138424|Primary|Number of Adverse Events by Grade of Event|"Adverse events are reported as grades:~Toxicity Grade I: a mild event (an event that requires minimal or no treatment and does not interfere with the subject's daily activities.~Toxicity Grade II: a moderate event (an event that results in a low level of inconvenience or concern with the therapeutic measures and may cause some interference with functioning.~Toxicity Grade III: a severe event (an event that interrupts a subject's usual daily activity and may require systemic drug therapy or other treatment and may be incapacitating.~Toxicity Grade IV: Life threatening (any adverse drug experience that places the patient or subject at immediate risk of death from the reaction as it occurred)"|Baseline through day 49.||||Events|||Number
2843084|NCT00138424|Secondary|Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine||Baseline through day 49.||||Days||Full Range|Median
2843085|NCT00138424|Secondary|Subjects Achieving 50% Reduction Viral Load in Plasma and Urine||Baseline through day 49.||||Participants|||Number
2843086|NCT00138424|Secondary|Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit|The percent change in viral load from baseline to day 7, day 21 and day 49 as measured in the urine and measured in the blood. A drop is identified by use of '-', an increase in viral load has no sign in front of the number.|Baseline, and each visit: day 7, 21, 35 and 49.||||Percent Change||Full Range|Median
2843087|NCT00138424|Secondary|The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR|The outcome measure is the percent of subjects that achieved non-detectable BK virus in the urine and plasma polymerase chain reaction (PCR) at day 35 after staring study drug. Undetectable is a PCR viral load of less than 200.|Day 35.|Percentage of subjects|||percentage of subjects|||Number
2843088|NCT00138424|Primary|Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject|The measure is the number of adverse events (ie: events that are change from baseline)experienced by subjects. The median or average number of events and the range of events across all subjects is reported.|Baseline through day 49||||Event||Full Range|Median
2843089|NCT00138294|Secondary|Proportion of SAEs Detected in LAIV Recipients|Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.|pre-, post- influenza vaccination|This analyses was limited to the children enrolled in the intervention cities. 29255 doses of LAIV were administered to children 4-18 years of age. 21555 doses were seasonal LAIV and 7700 doses were pandemic LAIV.|||proportion of events|||Number
2843163|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization|The number of participants with one or more weight service appointments in the one year during implementation (implementation sites versus control sites) for those participants who were overweight at the baseline interview (e.g., eligible for weight services). This only includes participants who were overweight at the baseline interview (e.g., eligible for weight services).|1 year||||participants|||Number
2843090|NCT00138294|Primary|MAARI Rate During the Epidemic and Pandemic Period (2009-2010)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|8/25/09 to 4/3/10 (32 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.|||Number of MAARI|Person Weeks||Number
2843091|NCT00138294|Primary|MAARI Rate During the Epidemic Period (2008-2009)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|1/4/2009 to 3/21/2009 (11 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.|||Number of MAARI|Person Weeks||Number
2843092|NCT00138294|Primary|MAARI Rate During the Epidemic Period (2007-2008)|The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.|12/16/2007 to 3/29/2008 (15 weeks)|Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.|||Number of MAARI|Person Weeks||Number
2843093|NCT00138203|Secondary|Toxicity|Number of participants experiencing adverse events possibly related to SAHA from first dose of treatment until 30 days from the last dose of treatment.|From first dose of treatment until 30 days from the last dose of treatment||||Participants|||Count of Participants
2843094|NCT00138203|Secondary|Overall Survial|Overall survial of subjects from the start of treatment to the time of death|From treatment start to time of death|All subjects who were considered evaulable (received more than one treatment cycle) were included in this evaluation|||months||Full Range|Median
2843095|NCT00138203|Secondary|Time to Progression|Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|From start of treatment to progression (average was 3.7 months)|Subjects who were considered evaluable (received more than one treatment cycle) were included in these results.|||months||Full Range|Median
2843096|NCT00138203|Primary|Response Per RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)|Only 14 subjects were evaulated for response. 2 of the total 16 subjects enrolled were not evaluable due to progression after only 1 cycle of treatment.|||participants|||Number
2843097|NCT00138151|Secondary|The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.||||||
2843098|NCT00138151|Secondary|The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.||||||
2843099|NCT00138151|Primary|Response Rate (Complete and Partial)|All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.|8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.||||||
2843100|NCT00138125|Secondary|Clinical Benefit (CR + PR + SD > 6 Months)|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
2843101|NCT00138125|Secondary|Overall Survival|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
2843102|NCT00138125|Secondary|Duration of Response|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
2843103|NCT00138125|Secondary|Time to Tumor Progression|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||||||
2843104|NCT00138125|Secondary|Overall Objective Response Rate|Two patients were treated on a truncated trial. Not enough data was generated for any analysis.|5 years|||2018||||
2843105|NCT00138125|Primary|Progression-free Survival|Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.|5 years||||participants|||Number
2843106|NCT00138073|Secondary|Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide|The study was terminated before the secondary outcome could be measured. Usage data was not collected over the following year.|1 year|||||||
2843107|NCT00138073|Primary|Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation|The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test.|1 month|||||||
2843108|NCT00138034|Secondary|Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography|The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.|6 months||||participants|||Number
2843109|NCT00138034|Primary|6-month Reocclusion|Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography|6 months||||participants|||Number
2843164|NCT00137267|Secondary|Number of Days Engaged|Number of days veteran was involved with the program, from initial consent to last day of contact|8 weeks||||Days engaged in program||Standard Deviation|Mean
2843110|NCT00137969|Secondary|Number of Participants Who Achieved an MCR in The ITT Population|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From Weeks 24 to 52|ITT population|||participants|||Number
2843111|NCT00137969|Secondary|Change in SLE Expanded Health Survey Physical Function Score From Baseline|Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved.|From baseline to 52 weeks|ITT population|||score on a scale||Standard Deviation|Mean
2843112|NCT00137969|Secondary|Time to First Moderate or Severe Flare|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state.|52 weeks|Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis.|||days||95% Confidence Interval|Median
2843113|NCT00137969|Secondary|Number of Participants Who Achieved a BILAG C or Better in All Domains|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains.|24 weeks|ITT population|||participants|||Number
2843114|NCT00137969|Secondary|Number of Participants Who Achieved a PCR (Including MCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From baseline to 52 Weeks|ITT population|||participants|||Number
2843115|NCT00137969|Secondary|Number of Participants Who Achieved an MCR (Excluding PCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|ITT population|||participants|||Number
2843116|NCT00137969|Secondary|Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as: 1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks. 2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study. 3. Minus the Time-Adjusted AUC by the baseline BILAG global score|From baseline to 52 weeks|ITT population|||BILAG score unit||Standard Deviation|Mean
2843117|NCT00137969|Primary|Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period|The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|Intent-to-treat (ITT) population|||Participants|||Number
2843118|NCT00137839|Secondary|Overall Survival by EGFR Mutation Status|OS is defined as the time from study entry to death or date last known alive.|In this study cohort, participants were followed for survival up to 155 months.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
2843119|NCT00137839|Secondary|Overall Survival (OS)|OS is defined as the time from study entry to death or date last known alive.|In this study cohort, participants were followed for survival up to 155 months.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2843165|NCT00137267|Primary|Treatment Engagement|Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period|8 weeks||||number of treatment sessions attended||Standard Deviation|Mean
2843120|NCT00137839|Secondary|Overall Response Rate (ORR) by EGFR Mutation Status|ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.|In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.|The analysis dataset is comprised of all treated participants.|||percentage of participants||95% Confidence Interval|Number
2843121|NCT00137839|Primary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.|In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.|The analysis dataset is comprised of all treated participants.|||percentage of participants||95% Confidence Interval|Number
2843122|NCT00137631|Primary|Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months||||number of episodes||Standard Deviation|Mean
2843123|NCT00137631|Primary|Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months||||number of episodes||Standard Deviation|Mean
2843124|NCT00137631|Primary|Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior||6 months||||participants|||Number
2843125|NCT00137631|Primary|Number of Participants Reporting HIV Testing Behavior||6 months||||participants|||Number
2843126|NCT00137631|Primary|Any Unprotected Anal Intercourse (UAI) With Casual Partners|Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)|6 months||||Number of episodes||Standard Deviation|Mean
2843127|NCT00137449|Secondary|Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for >=10 subjects).|Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study|ITT population|||score on scale||Full Range|Median
2843128|NCT00137449|Secondary|Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)|"EQ-VAS score on the self-rated thermometer, indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for >=10 subjects."|Baseline, Day 1 &15 of each treatment cycle up to 1 year on study|ITT population.|||score on scale||Full Range|Median
2843129|NCT00137449|Secondary|Score of FACIT-Fatigue Scale|FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for >=10 subjects.|Baseline, Day 1 & 15 of each treatment cycle|ITT population|||score on scale||Standard Deviation|Mean
2843130|NCT00137449|Secondary|Overall Survival (OS) and One-year Survival [Descriptive Statistics]|Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication.|Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.|ITT population (all subjects enrolled that received at least 1 dose of study medication).|||participants|||Number
2843131|NCT00137449|Secondary|Duration of Tumor Response (DR) [Descriptive Statistics]|DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8)|||weeks||Full Range|Median
2843132|NCT00137449|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
2843133|NCT00137449|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
2843134|NCT00137449|Secondary|Duration of Stable Disease|Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||Participants|||Number
2843135|NCT00137449|Secondary|Number of Participants With Overall Confirmed Objective Disease Response (ORR)|Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
2843136|NCT00137449|Secondary|Number of Participants by Best Confirmed Response Category According to RECIST|Best confirmed response (BCR) defined as best response [confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.|||participants|||Number
2843137|NCT00137449|Primary|Number of Participants With Clinical Benefit Response (CBR) According to RECIST|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for >=24 weeks)|||participants|||Number
2843138|NCT00137436|Secondary|Preliminary Assessment of PSA Modulation by SU011248|PSA modulation analyzed by the mean change in PSA response measured as ng/mL.|Baseline to Day 28|ITT population; PSA modulation was listed as a secondary endpoint for Phase 2, however, modulation was planned for analysis only for Phase 1 portion of the study. No formal analysis was completed to determine modulation.|||ng/mL||95% Confidence Interval|Mean
2843139|NCT00137436|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)|Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.|||scores on a scale||95% Confidence Interval|Mean
2843140|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.|||scores on a scale||95% Confidence Interval|Mean
2843141|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|Patient reported outcomes (PRO) evaluable population defined as participants in the ITT population who received at least 1 dose of study medication (sunitinib or docetaxel) and had baseline data; (n)=number of participants with evaluable data at observation.|||scores on a scale||95% Confidence Interval|Mean
2843142|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3|Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT|||pg/mL||Full Range|Median
2843143|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2|Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT|||pg/mL||Full Range|Median
2843193|NCT00137046|Primary|Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)|Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.|Month 3 through Extension Follow-up 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
2843144|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC|Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT|||pg/mL||Full Range|Median
2843145|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3|Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT|||pg/mL||Full Range|Median
2843146|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2|Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT|||pg/mL||Full Range|Median
2843147|NCT00137436|Secondary|Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC|Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT|||pg/mL||Full Range|Median
2843148|NCT00137436|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type.|||percentage of participants||95% Confidence Interval|Number
2843149|NCT00137436|Secondary|Duration of PSA Response (DPR)|Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR - first PSA response + 1)/7.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; DPR only calculated for the subgroup of patients with PSA response rate.|||weeks||Full Range|Median
2843150|NCT00137436|Secondary|Time to PSA Progression|Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date - first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT|||weeks||Full Range|Median
2843151|NCT00137436|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.|Baseline, Day 1 of each 21-day cycle|The intent-to-treat (ITT) population was defined as all patients enrolled in the study that receive at least 1 dose of study medication (SU011248 or docetaxel)|||percentage of participants||95% Confidence Interval|Median
2843152|NCT00137423|Secondary|Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score|"EQ-VAS score on the self-rated thermometer indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline)."|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT|||score on scale||Full Range|Median
2843153|NCT00137423|Secondary|Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index|EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT|||score on scale||Full Range|Median
2843166|NCT00137111|Other Pre-specified|Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay|||arbitrary units||Inter-Quartile Range|Median
2843154|NCT00137423|Secondary|Summary of FACIT Fatigue Scale Overall Score|FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT; Results summarized by cohort & time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires.|||score on scale||Standard Deviation|Mean
2843155|NCT00137423|Secondary|Overall Survival|Overall survival is time from the date of first dose of medication to the date of death due to any cause|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM).|||weeks||95% Confidence Interval|Median
2843156|NCT00137423|Secondary|Progression Free Survival (PFS)|Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM).|||weeks||95% Confidence Interval|Median
2843157|NCT00137423|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM).|||weeks||95% Confidence Interval|Median
2843158|NCT00137423|Secondary|Duration of Tumor Response|Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death & calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM).|||weeks||Full Range|Median
2843159|NCT00137423|Primary|Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects|Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM)|||participants|||Number
2843160|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes|Chi-square analysis was used to examine competitive employment gained during treatment in implementation versus control groups. The dependent variable was competitive employment. Individuals included were only those who expressed interest in returning to work at both the baseline and follow-up interview time-points.|1 year||||competitive employment|||Number
2843161|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization|The number of participants with one or more Supported Employment appointments in the one year during implementation (implementation sites versus control sites) for those participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services). This only includes participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services).|1 year||||participants|||Number
2843162|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes|Analysis of Covariance (ANCOVA) was used to examine weight gained during treatment in implementation versus control groups. The dependent variable was final weight. Baseline weight, weight 6 months prior to baseline, and baseline psychotic and negative symptom subscales were included as covariates. The inclusion of weight 6 months prior to baseline served to control for subjects' weight gain/loss trajectories prior to entering the study. The two-way interactions of group by covariates were also included in the model.|1 year||||pounds||Standard Error|Least Squares Mean
2843217|NCT00136916|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Baseline through extension follow up Month 3|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned.|||L||Standard Deviation|Mean
2843167|NCT00137111|Other Pre-specified|Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.|||arbitrary units||Inter-Quartile Range|Median
2843168|NCT00137111|Secondary|Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)|"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count~Measurement: Percentage change of leukemia cells from baseline"|Immediately before the methotrexate infusion and three days after subsequent infusion|Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate’s antileukemic effects.|||Percent change||Standard Deviation|Mean
2843169|NCT00137111|Secondary|Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).|Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.|42 hours after start of high dose methotrexate infusion (HDMTX)|The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .|||pmol/1,000,000,000 cells||Standard Deviation|Mean
2843170|NCT00137111|Secondary|Minimal Residual Disease (MRD)|Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).|End of Induction (Day 46 MRD measurement)|Patients who completed induction and had successful MRD studies on day 46.|||participants|||Number
2843171|NCT00137111|Primary|Continuous Complete Remission Since Week 56 Therapy.|CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.|Median follow up time (range) 4.5 (1 to 7.8) years|Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.|||Percentage of participants|||Number
2843172|NCT00137111|Primary|Overall Event-free Survival (EFS)|EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.|Median follow-up time (range) 5.6 (1.3 to 8.9) years|498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.|||Percentage of Participants|||Number
2843173|NCT00137046|Secondary|Insulin Antibodies|Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).|Baseline through Extension Month 39|FAS; (n)= number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.|||microU/mL||Full Range|Median
2843174|NCT00137046|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the annual rate of change in DLco were not summarized as planned.|||ml/min/mmHg/yr||Standard Deviation|Mean
2843175|NCT00137046|Primary|Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Annual Rate of Change in FEV1 were not summarized as planned.|||liters per year||Standard Deviation|Mean
2843176|NCT00137046|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and TLC results were not summarized as planned.|||liters||Standard Deviation|Mean
2843177|NCT00137046|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and FVC results were not summarized as planned.|||liters||Standard Deviation|Mean
2843178|NCT00137046|Primary|Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).|Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.|Month 3 through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
2843179|NCT00137046|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Due to study termination, originally planned inferential analysis change from Month 3 to extension Month 60 was not done.|||mL/min/mmHg||Standard Deviation|Mean
2843192|NCT00137046|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||percent||Standard Deviation|Mean
2843180|NCT00137046|Secondary|Cough Questionnaire|Subject completed cough questionnaire with reference to the past 4 weeks. Six question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (subcutaneous [SC] or inhaled), and productivity of cough; range 0 (no symptoms) to 4 (severe symptoms). Questionnaire was administered at Week 0 and then at subsequent visits only if cough was identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through Extension Follow up Month 3|FAS. Due to early termination of the study a limited set of analyses were undertaken and results of the Cough Questionnaire were not summarized as planned.|||scores on scale||Standard Deviation|Mean
2843181|NCT00137046|Secondary|Lipids|Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|Full Analysis Set (FAS): received at least 1 dose of study treatment. Due to early termination of the study a limited set of analyses were undertaken and lipid results were not summarized as planned.|||mg/dL||Standard Deviation|Mean
2843182|NCT00137046|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Transition Dyspnea Index were not summarized as planned.|||scores on scale||Standard Deviation|Mean
2843183|NCT00137046|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.|Week - 1|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Baseline Dyspnea Index were not summarized as planned.|||scores on scale||Standard Deviation|Mean
2843184|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams [mg] or units divided by kilograms [kg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/kg, units/kg||Standard Deviation|Mean
2843185|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg, units||Standard Deviation|Mean
2843186|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units/kg||Standard Deviation|Mean
2843187|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units||Standard Deviation|Mean
2843188|NCT00137046|Secondary|Change From Baseline Body Weight|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight.|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||kilograms||Standard Deviation|Mean
2843189|NCT00137046|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/dL||Standard Deviation|Mean
2843190|NCT00137046|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||events / subject months * 100|||Number
2843191|NCT00137046|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||total events/subject months|||Number
2846606|NCT00107172|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause.|Up to 5 years|All intent-to-treat (ITT) participants|||years||95% Confidence Interval|Median
2843194|NCT00137046|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.|||liters||Standard Deviation|Mean
2843195|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (ITT Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.|||days||95% Confidence Interval|Median
2843196|NCT00136955|Primary|Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.|||participant|||Number
2843197|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.|||days||95% Confidence Interval|Median
2843198|NCT00136955|Primary|Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.|||participant|||Number
2843199|NCT00136916|Secondary|Insulin Antibodies|Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).|Baseline through extension Month 36|FAS; (n)=number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.|||microU/mL||Full Range|Median
2843200|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits|"Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. No response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn)."|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.|||participants|||Number
2843201|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits|Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.|||participants|||Number
2843202|NCT00136916|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TDI were not summarized as planned.|||scores on scale|||Number
2843203|NCT00136916|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.|Week -1|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of BDI were not summarized as planned.|||scores on scale|||Number
2843218|NCT00136916|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned.|||L||Standard Deviation|Mean
2843204|NCT00136916|Secondary|Cough Questionnaire|Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through extension follow up Month 3|FAS. Due to early termination of study a limited set of analyses were undertaken and results of Cough Questionnaire were not summarized as planned.|||scores on scale|||Number
2843205|NCT00136916|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval.|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||event rate (events/subject months*100)|||Number
2843206|NCT00136916|Secondary|Hypoglycemic Event Rates|Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||event rate (events/subject months)|||Number
2843207|NCT00136916|Primary|Summary of ≥ 20 % Decliners in DLco|Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
2843208|NCT00136916|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco).|||ml/min/mmHg||Standard Deviation|Mean
2843209|NCT00136916|Secondary|Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides|Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|FAS: received at least 1 dose of study treatment. Due to early termination of study a limited set of analyses were undertaken and results of Lipids were not summarized as planned.|||mg/dL||Standard Deviation|Mean
2843210|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)|Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/kg, units/kg||Standard Deviation|Mean
2843211|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg, units||Standard Deviation|Mean
2843212|NCT00136916|Secondary|Total Daily Long-acting Insulin (Adjusted for Body Weight)|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units/kg||Standard Deviation|Mean
2843213|NCT00136916|Secondary|Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)|Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||units||Standard Deviation|Mean
2843214|NCT00136916|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||kg||Standard Deviation|Mean
2843215|NCT00136916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||mg/dL||Standard Deviation|Mean
2843216|NCT00136916|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||percent||Standard Deviation|Mean
2843219|NCT00136916|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco).|||ml/min/mmHg/yr||Standard Deviation|Mean
2843220|NCT00136916|Primary|Summary of ≥ 15 % Decliners in FEV1|Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.|||participants|||Number
2843221|NCT00136916|Primary|Annual Rate of Change in FEV1|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.|||L/yr||Standard Deviation|Mean
2843222|NCT00136916|Primary|Change From Baseline in FEV1|Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.|||L||Standard Deviation|Mean
2843223|NCT00136916|Primary|Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)|Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).|Month 3 through extension Month 60|Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.|||L||Standard Deviation|Mean
2843224|NCT00136838|Other Pre-specified|Craving|Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).|immediately following cue expose||||units on a scale (0-70)||Standard Error|Mean
2843225|NCT00136838|Primary|Cigarette Choice After 3 Day Abstinence|Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices|During Day 4 experimental session||||number of cigarette choices (0-6)||Standard Error|Mean
2843226|NCT00136812|Primary|7 Day Point Prevalence of Cigarette Abstinence||3 mo, 6 mo, 12 mo, and 18 mo post-baseline||||% quit||95% Confidence Interval|Number
2843227|NCT00136760|Secondary|Cigarettes Smoked Per Day||3 weeks||||cigarettes per day||Standard Deviation|Mean
2843228|NCT00136760|Primary|Urinary Cotinine|Urinary Cotinine levels at Week 4 (average of last 3 study visits)|3 weeks||||ng/ml||Standard Deviation|Mean
2843229|NCT00136695|Primary|Lean Body Mass||1 year||||grams||Standard Deviation|Mean
2843230|NCT00136604|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to one month Post-Booster vaccination|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.|||Participants|||Count of Participants
2843231|NCT00136604|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.|||Participants|||Count of Participants
2843232|NCT00136604|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.|||Participants|||Count of Participants
2843233|NCT00136604|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) post-vaccination period|The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.|||Participants|||Count of Participants
2843234|NCT00136604|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||mIU/ml||95% Confidence Interval|Geometric Mean
2843301|NCT00135707|Secondary|Creatinine ≥1.5 mg/dl (133 μmol/Liter)||20 weeks through discharge||||Participants|||Count of Participants
2843302|NCT00135707|Secondary|Aspartate Aminotransferase ≥100 U/Liter||20 weeks through discharge||||Participants|||Count of Participants
2843235|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value|Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||Percentage|||Number
2843236|NCT00136604|Secondary|Anti-BPT Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||EL.U/ml||95% Confidence Interval|Geometric Mean
2843237|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value|Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).|One month Post-Booster vaccination|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination|||Percentage|||Number
2843238|NCT00136604|Secondary|Anti-TT Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||IU/mL||95% Confidence Interval|Geometric Mean
2843239|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||Percentage|||Number
2843240|NCT00136604|Secondary|Anti-D Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination|||IU/mL||95% Confidence Interval|Geometric Mean
2843241|NCT00136604|Secondary|Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were < 0.1 IU/ml when assessed by ELISA.|One month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination.|||Percentage|||Number
2843242|NCT00136604|Secondary|Anti-PSA Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||µg/ml||95% Confidence Interval|Geometric Mean
2843243|NCT00136604|Secondary|Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||Percentage|||Number
2843244|NCT00136604|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||µg/ml||95% Confidence Interval|Geometric Mean
2843245|NCT00136604|Secondary|Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||Percentage|||Number
2843246|NCT00136604|Secondary|Anti-rSBA-MenA Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||Titers||95% Confidence Interval|Geometric Mean
2843247|NCT00136604|Secondary|Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values|Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.|||Percentage|||Number
2843248|NCT00136604|Secondary|Anti-SBA-MenC Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||Titers||95% Confidence Interval|Geometric Mean
2843249|NCT00136604|Secondary|Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values|Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.|||Percentage|||Number
2843250|NCT00136604|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2843251|NCT00136604|Secondary|Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values|Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).|Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.|||Percentage|||Number
2843252|NCT00136604|Primary|Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value|Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).|One Month Post-Booster vaccination at 15-24 months of age|The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT versus Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix groups.|||Percentage|||Number
2843253|NCT00136604|Primary|Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value|Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).|One Month Post-Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group only.|||Percentage|||Number
2843254|NCT00136604|Primary|Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value|Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.|One month Post-Booster vaccination at 15-24 months of age|The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group versus TRITANRIX-HEPB+Mencevax + Meningitec Group.|||Percentage|||Number
2843255|NCT00136357|Primary|Harvard Trauma Questionnaire|The Harvard Trauma Questionnaire measures PTSD Symptoms. This scale has 16 items and is rated on a Likert scale from 1-4. The total score is sum of the scores divided by the number of items. Higher scores indicated higher levels of PTSD symptoms.|Baseline, 12 weeks, 3 months||||units on a scale||Standard Deviation|Mean
2843256|NCT00136318|Secondary|Safety||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment|||||||
2843257|NCT00136318|Secondary|Tolerability||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment|||||||
2843258|NCT00136318|Secondary|Sustained Virologic Response|(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)|assessed 24 weeks after end of antiviral treatment|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.|||percentage of participants||95% Confidence Interval|Number
2843259|NCT00136318|Secondary|Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)||assessed 2,4,12,24 and 48 weeks of antiviral treatment|||||||
2843260|NCT00136318|Secondary|Severe Depression Defined as a MADRS Score of 25 or Higher||severe depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.|||percentage of participants||95% Confidence Interval|Number
2843261|NCT00136318|Secondary|Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria||major depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.|||percentage of participants||95% Confidence Interval|Number
2843262|NCT00136318|Secondary|Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)|Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression|Patients free of depression during 24 or 48 weeks of antiviral therapy|Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy.|||participants|||Number
2843263|NCT00136318|Primary|Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher|"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)"|50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3|The final analysis included only patients who received at least one of escitalopram or placebo. Between group differences for the primary outcome parameters were calculated with a chi-square test. For the primary end point (MADRS score of 13 or higher), we treated missing MADRS assessments by multiple imputation.|||percentage of participants||95% Confidence Interval|Number
2843264|NCT00136214|Primary|Neurocognitive Tests for Cerebral Function|A battery of pen and paper neurocognitive tests where subject means are reported compared to the normative Z score. Data is reported at baseline (T1), week 12 on treatment (T2) and 12 weeks after treatment (week 60, T3). Improvements are increases in the test result compared to baseline as determined against the Z score. tests performed included Hopkins learning trials (HVLT), a measure of of verbal learning and memory and the Roy-Osterrieth Complex figure test (ROCF) which evaluates visio-spatal abilities, memory, planning and working memory. Improvements in the score (increases in value compared, either less negative or more positive to the Z score) shown in the table are reflective of improvements in these neurocognitive parameters.|18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline and only done in treated group and not controls||||Z-score||Standard Deviation|Mean
2843265|NCT00136214|Primary|Ratios of Cerebral Metabolites Choline (CH), Myoinisitol (MI) and N-acety Aspartate (NAA)to Creatine (Cr) in 3 Brain Regions Including Basal Ganglia, Frontal Cortex and Left Dorsolateral Prefrontal Cortex|Evaluation of changes in MR spectroscopy. reductions in ratio of Cho and MI reflect improvements in cerebral inflammation and improvement in cognition. Increases in the NAA ratio are suggestive of improvement in cognitive function.|18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline|One patient dropped out secondary to claustrophobia and was unable to complete MR portion of study|||ratio||Standard Deviation|Mean
2843266|NCT00136084|Secondary|Relationship of Inhibition of DNA Synthesis and Clinical Response|Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.|||Percent inhibition of DNA Synthesis||Standard Error|Mean
2843267|NCT00136084|Secondary|To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy|Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.|||Percent Inhibition of DNA Synthesis||Standard Error|Mean
2843268|NCT00136084|Secondary|To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy|Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up|Five Year|238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.|||Percentage of Participants|||Number
2843269|NCT00136084|Secondary|Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.|To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy|Induction II|30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.|||Participants|||Number
2843270|NCT00136084|Secondary|Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO|To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.|Induction II|Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.|||Participants|||Number
2843303|NCT00135707|Secondary|Medically Indicated Delivery Because of Hypertension||20 weeks through discharge following delivery||||Participants|||Count of Participants
2843304|NCT00135707|Secondary|Pregnancy Associated Hypertension||20 weeks through discharge following delivery||||Participants|||Count of Participants
2843271|NCT00136084|Secondary|Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)|To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)|Consolidation I|Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.|||Participants|||Number
2843272|NCT00136084|Primary|Minimal Residual Disease (MRD).|Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%).|Day 22 MRD measurement|Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.|||participants|||Number
2843273|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP)|Per-Protocol (PP) analyses of all patients. Combined Virologic Response (CVR)includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR), analysed among patients who received treatment.|Pre-transplant and 3 months post-transplant|All study patients|||participants|||Number
2843274|NCT00135798|Primary|Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation, analysed among patients who received treatment.|3 months post-transplant|Per-Protocol (PP) analyses of Transplanted patients who received treatment. Outcome is pTVR (post-transplant viral response)|||participants|||Number
2843275|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT)|Intent-to-Treat (ITT) analyses of all patients. Combined Virologic Response (CVR), which includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR)|Pre-transplant and 3 months post-transplant|All study patients|||participants|||Number
2843276|NCT00135798|Primary|Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.|3 months post-transplant|Intent-to-Treat (ITT) analyses of Transplanted patients assigned to treatment. Outcome is pTVR (post-transplant viral response)|||participants|||Number
2843277|NCT00135707|Post-Hoc|Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy|Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized before the 13th week of pregnancy.|During pregnancy||||Participants|||Count of Participants
2843278|NCT00135707|Post-Hoc|Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy|Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized on or after the 13th week of pregnancy.|During pregnancy||||Participants|||Count of Participants
2843279|NCT00135707|Secondary|Neonatal Hospital Stay||Birth through discharge from hospital|Live born infants|||days||Inter-Quartile Range|Median
2843280|NCT00135707|Secondary|Apgar Score <=3 at 5 Minutes||At birth||||participants|||Number
2843281|NCT00135707|Secondary|Retinopathy of Prematurity||Within 1 month of birth|Live born infants|||Participants|||Count of Participants
2843282|NCT00135707|Secondary|Necrotizing Enterocolitis||Delivery through discharge|Live born infants|||Participants|||Count of Participants
2843283|NCT00135707|Secondary|Sepsis||Delivery through discharge|Live born infants|||Participants|||Count of Participants
2843284|NCT00135707|Secondary|Intraventricular Hemorrhage, Grade III or IV||Delivery through discharge|Live born infants|||Participants|||Count of Participants
2843285|NCT00135707|Secondary|Respiratory Distress Syndrome||Delivery through discharge|Live born infants|||Participants|||Count of Participants
2843286|NCT00135707|Secondary|Admission to NICU|NICU denotes neonatal intensive care unit.|Delivery through discharge|Live born infants|||Participants|||Count of Participants
2843287|NCT00135707|Secondary|Birth Weight <2500 Grams||At birth|Live born infants|||Participants|||Count of Participants
2843288|NCT00135707|Secondary|Small for Gestational Age|A baby whose birth weight is less than the 3rd percentile is considered to be small for gestational age (adjusted for sex and race or ethnic group)|At birth|Live born infants|||Participants|||Count of Participants
2843289|NCT00135707|Secondary|Birth Weight||At birth|Liveborn infants|||grams||Standard Deviation|Mean
2843290|NCT00135707|Secondary|Fetal or Neonatal Death||During pregnancy or thorugh discharge||||Participants|||Count of Participants
2843291|NCT00135707|Secondary|Preterm Birth||Delivery||||Participants|||Count of Participants
2843292|NCT00135707|Secondary|Gestational Age at Delivery||Delivery||||weeks||Standard Deviation|Median
2843293|NCT00135707|Secondary|Maternal Hospital Stay||Delivery through discharge||||days||Inter-Quartile Range|Median
2843294|NCT00135707|Secondary|Hematocrit ≤24% With Transfusion||Delivery admission to discharge||||Participants|||Count of Participants
2843295|NCT00135707|Secondary|Postpartum Pulmonary Edema||After delivery through discharge||||Participants|||Count of Participants
2843296|NCT00135707|Secondary|Maternal Death||Delivery through hospital discharge|One maternal death in each group due to peripartum cardiomyopathy.|||Participants|||Count of Participants
2843297|NCT00135707|Secondary|Cesarean Delivery||Delivery||||Participants|||Count of Participants
2843298|NCT00135707|Secondary|Placental Abruption||During pregnancy||||Participants|||Count of Participants
2843299|NCT00135707|Secondary|Premature Rupture of Membranes||During pregnancy||||Participants|||Count of Participants
2843300|NCT00135707|Secondary|Antepartum Bleeding||During pregnancy||||Participants|||Count of Participants
2843306|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge or prior to discharge following delivery admission||||Participants|||Count of Participants
2843307|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2843308|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2843309|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure|Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2843310|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level|Elevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2843311|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia|Thrombocytopenia defined as a platelet count of <100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||participants|||Number
2843312|NCT00135707|Primary|Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels|Elevated liver enzyme levels are specified as an aspartate aminotransferase level of >= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2843313|NCT00135707|Primary|Severe Hypertension|Included here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death.|20 weeks through discharge following delivery||||Participants|||Count of Participants
2843314|NCT00135707|Primary|Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate|Severe hypertension (blood pressure [BP]>= 160/110) or mild hypertension (BP>= 140/90) >= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death|20 weeks through discharge following delivery|The analysis was intent to treat.|||Participants|||Count of Participants
2843315|NCT00135694|Secondary|Total Burden of Immunosuppression From Random Assignment to Month 24|Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.).|Randomization to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.|||units||Full Range|Mean
2843316|NCT00135694|Secondary|Total Immunosuppression From Month 21 to Month 24 Post-randomization|Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.)|Month 21 to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.|||units per day||Full Range|Mean
2843317|NCT00135694|Secondary|Number of Participants Experiencing Graft Loss or Death|Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation.|Randomization to 2 years post-randomization.|Randomized participants (intent-to-treat sample)|||participants|||Number
2843318|NCT00135694|Secondary|Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale|Number of subjects with a biopsy showing stage 4 fibrosis or higher on the Ishak scale. Stage 4 represents at least 13.7% fibrosis measurement with a description of fibrous expansion of portal areas with marked bridging (P-P) as well as portal to central (P-C). Stage 5 is marked bridging (P-P and/or P-C), with occasional nodules (incomplete cirrhosis) and stage 6 is cirrhosis, probable or definite.|Randomization to 2 years post-randomization.|Hepatitis C infected participants randomized.|||participants|||Number
2845371|NCT00116779|Secondary|Number of Participants With Abnormal Alanine Aminotransferase Values|Participants whose alanine aminotransferase values were at levels above the normal range.|Day 1 through day 364|ITT population|||participants|||Number
2843319|NCT00135694|Secondary|Immunosuppression-free Duration|Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion.|Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years|Participants randomized to immunosuppression withdrawal who completed withdrawal and discontinued all immunosuppression|||Days||Full Range|Mean
2843320|NCT00135694|Secondary|Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months||Randomization until study completion or participant termination (up to six years post-transplant)|Participants randomized to immunosuppression withdrawal|||participants|||Number
2843321|NCT00135694|Secondary|Number of Participants Who Qualify for Random Assignment||One to two years post-transplantation|All subjects transplanted|||participants|||Number
2843322|NCT00135694|Primary|Number of Participants With Clinical Complications Usually Attributed to Immunosuppression|This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared.|Randomization to 2 years post-randomization|Evaluable randomized subjects having a targeted event and/or having available data for calculation of eGFR|||participants|||Number
2843323|NCT00135512|Secondary|Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases|The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy and social motivation. Minimal clinically important differences were estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels and items were reverse-scored as necessary such that higher scores represent higher health-related quality of life (HRQoL) total score ranges from 0 to 108 points. Recall period was past week prior to administration. The change from Baseline in MEI-SF total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.|Baseline (Week 0) and Week 8, 52|Full analysis set was used.|||Score on a scale||Standard Deviation|Mean
2843324|NCT00135512|Secondary|Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases|"SDISS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. To get a total score, 3 individual scores were added and the total score ranged from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening. The change from Baseline in SDISS total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0."|Baseline (Week 0) and Week 8, 52|Full analysis set was used.|||Score on a scale||Standard Deviation|Mean
2843325|NCT00135512|Secondary|Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases|CGI-SI was assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill and 7, among the most extremely ill. Higher score indicated severely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.|Baseline (Week 0) and Week 8, 52|Full analysis set was used.|||Score on a scale||Standard Deviation|Mean
2843326|NCT00135512|Secondary|Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases|"The CGI-I scale was used to rate improvement in the participant's condition (benefits) since Baseline using the following 7-point scale: 1: very much improved, 2: much improved, 3: minimally improved, 4: not changed, 5: minimally worse, 6: much worse and 7: very much worse. A responder was defined as very much improved or much improved."|Week 8, 52|Full analysis set was used.|||Percentage of participant||95% Confidence Interval|Number
2843327|NCT00135512|Secondary|Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases|Each item was rated on either a 3-point scale (0 to 2; 8 questions) or a 5-point scale (0 to 4; 9 questions), with higher scores indicating greater symptom severity. The total score was calculated by summing the individual response scores. Total score ranged from 0 to 52. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. Change from Baseline in the total score was calculated as the score at Week 8 and 52 minus the score at Baseline. Baseline was defined as value at Week 0.|Baseline (Week 0) and Week 8, 52|Full analysis set was used.|||Score on a scale||Standard Deviation|Mean
2843328|NCT00135512|Secondary|Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases|The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 52 minus the value at Baseline. Baseline was defined as value at Week 0.|Baseline (Week 0) and Week 52|Full analysis set was used.|||Score on a scale||Standard Deviation|Mean
2843329|NCT00135512|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases|The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0.|Baseline (Week 0) and Week 8|Full analysis set was used.|||Score on a scale||Standard Deviation|Mean
2843330|NCT00135356|Secondary|Mean Change From Baseline in CD4 Count|Mean change from baseline in CD4 count among treated subjects|Baseline, Week 48, Week 96|Observed Cases (OC)|||cells/mm3||Standard Error|Mean
2843331|NCT00135356|Secondary|Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline|Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.|Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96|Treated subjects with HIV RNA <400 c/mL at baseline.|||Proportion of participants|||Number
2843332|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation|Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).|Through Week 96|Treated subjects|||Percent of Participants|||Number
2843333|NCT00135356|Secondary|Percentage of Participants With Abnormal Liver Function Tests|Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.|Week 48, Week 96|All treated participants|||Percentage of Participants|||Number
2843334|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Through Week 96 of study therapy|Treated participants|||Percentage of Participants|||Number
2843335|NCT00135356|Secondary|Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96|Mean changes from baseline in proportion of waist to hip measurements.|Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||ratio||Standard Error|Mean
2843336|NCT00135356|Secondary|Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||kg/m2||Standard Error|Mean
2843337|NCT00135356|Secondary|Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||cm||Standard Error|Mean
2843338|NCT00135356|Secondary|Mean Changes From Baseline in Body Weight at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint|||kg||Standard Error|Mean
2843339|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.|Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.|||mg/dL x uU/mL||Standard Error|Mean
2843340|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.|||microunits per milliliter||Standard Error|Mean
2843341|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.|||mg/dL||Standard Error|Mean
2843342|NCT00135356|Secondary|Mean Percent Changes From Baseline in Fasting Lipids|Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B|Baseline, Week 48, Week 96|Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints|||Percent change|||Number
2843343|NCT00135356|Secondary|Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans|The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint|||percent change||Inter-Quartile Range|Mean
2843344|NCT00135356|Secondary|Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans|The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint.|||percent change||Inter-Quartile Range|Mean
2843345|NCT00135356|Secondary|Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.|The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint.|||Percent change||Inter-Quartile Range|Mean
2843346|NCT00135356|Secondary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 96|Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.|||ratio||Standard Error|Mean
2843347|NCT00135356|Primary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48|Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 48|Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.|||ratio||Standard Error|Mean
2843348|NCT00135330|Secondary|Pedal Edema Score|"Pedal edema scores experienced by each patient throughout the study (1+ indicates a patient experienced a pedal edema score of 1 , 2, or 3; 2+ indicates a patient experienced a pedal edema score of 2 or 3, etc.)~Scale:~Slight pitting, no visible distortion, disappears rapidly~A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds~The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen~The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted"|20 weeks|Full Analysis Set|||participants|||Number
2843349|NCT00135330|Secondary|Hypoglycemia Rate Per 30 Days Per Patient|Average number of episodes of hypoglycemia per 30 days per patient|20 weeks|Full Analysis Set|||hypoglycemia events / 30 days / patient||Standard Deviation|Mean
2843350|NCT00135330|Secondary|Incidence of Hypoglycemia Events|Number of subjects experiencing hypoglycemia at any point during the study|20 weeks|Full Analysis Set|||participants|||Number
2843351|NCT00135330|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set|||ratio (cm/cm)||Standard Error|Least Squares Mean
2843352|NCT00135330|Secondary|Change in Hip Circumference|Change in hip circumference form baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set|||cm||Standard Error|Least Squares Mean
2843353|NCT00135330|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set|||cm||Standard Error|Least Squares Mean
2843354|NCT00135330|Secondary|Change in Lean Body Mass During a Meal Challenge Test (MCT)|Change in lean body mass from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements|||kg||Standard Error|Least Squares Mean
2843355|NCT00135330|Secondary|Change in Body Fat Mass During a Meal Challenge Test (MCT)|Change in body fat mass form baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements|||kg||Standard Error|Least Squares Mean
2843356|NCT00135330|Secondary|Change in Percent Body Fat During a Meal Challenge Test (MCT)|Change in percent body fat from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement|||percentage||Standard Error|Least Squares Mean
2843357|NCT00135330|Secondary|Change in Fasting Triglycerides|Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set|||mmol/L||Standard Error|Geometric Mean
2843358|NCT00135330|Secondary|Change in Fasting LDL Cholesterol|Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
2843359|NCT00135330|Secondary|Change in Fasting HDL Cholesterol|Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
2843360|NCT00135330|Secondary|Change in Fasting Total Cholesterol.|Change in fasting total cholestrol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
2843361|NCT00135330|Secondary|Change in Body Weight|Change in body weight from baseline to week 20.|Week 20|All patients who aave both baseline and at least one post baseline value in full analysis set.|||kg||Standard Error|Least Squares Mean
2843365|NCT00135330|Secondary|Change in Fasting Serum Glucose Concentration.|Change in fasting serum glucose concentration from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||mmol/L||Standard Error|Least Squares Mean
2843366|NCT00135330|Secondary|Change in HbA1c|Change in HbA1c from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.|||Percentage||Standard Error|Least Squares Mean
2843367|NCT00135330|Secondary|Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).|Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.|Week 20|All patients in full analysis set who have baseline and endpoint measurement.|||mmol/L||Standard Error|Least Squares Mean
2843368|NCT00135330|Secondary|Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).|Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||mmol/L||Standard Error|Least Squares Mean
2843369|NCT00135330|Secondary|Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).|Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||mmol/L||Standard Error|Least Squares Mean
2843370|NCT00135330|Secondary|Change in AUC for C-peptide During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||nmol-min/L||Standard Error|Geometric Mean
2843371|NCT00135330|Secondary|Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||uIU-min/ml||Standard Error|Geometric Mean
2843372|NCT00135330|Secondary|Change in Insulin iAUC From Baseline to Endpoint.|"Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.|||uIU-min/ml||Standard Error|Least Squares Mean
2843373|NCT00135330|Secondary|Change in Insulin AUC in the First Stage From Baseline to Endpoint.|"Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint|||uIU-min/ml||Standard Error|Least Squares Mean
2843374|NCT00135330|Secondary|Change in Insulin Sensitivity Index as Measured by M-value.|Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.|Week 20|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.|||mg/kg-min||Standard Error|Least Squares Mean
2843375|NCT00135330|Secondary|Change in AUC for Glucose During a Meal Challenge Test (MCT).|Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.|||mmol-min/L||Standard Error|Least Squares Mean
2843376|NCT00135330|Primary|Change in ASIiAUC During a Hyperglycemic Clamp Test.|Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.|20 weeks|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.|||uIU-min/ml||Standard Error|Least Squares Mean
2843377|NCT00135226|Other Pre-specified|Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only)|Includes fatal and non-fatal events, excludes atrial fibrillation.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843378|NCT00135226|Other Pre-specified|Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only)|Includes fatal and non-fatal events.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843379|NCT00135226|Other Pre-specified|Number of Participants With Event: Unspecified Cancer|Includes fatal and non-fatal cancers of unknown type.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843380|NCT00135226|Other Pre-specified|Number of Participants With Event: Other Cancer|Includes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known).|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843381|NCT00135226|Other Pre-specified|Number of Participants With Event: Melanoma|Includes fatal and non-fatal melanomas.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843382|NCT00135226|Other Pre-specified|Number of Participants With Event: Breast Cancer|Includes fatal and non-fatal cancers.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843383|NCT00135226|Other Pre-specified|Number of Participants With Event: Hematological Cancer|Includes fatal and non-fatal cancers. Includes leukaemia and lymphoma.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843384|NCT00135226|Other Pre-specified|Number of Participants With Event: Genitourinary Cancer|Includes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843385|NCT00135226|Other Pre-specified|Number of Participants With Event: Respiratory Cancer|Includes fatal and non-fatal cancers. Includes lung and larynx cancer.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843386|NCT00135226|Other Pre-specified|Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only)|Includes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843578|NCT00132028|Secondary|Overall Survival|Measured from date of registration to death, or last contact date|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing overall survival.|||months||95% Confidence Interval|Median
2843387|NCT00135226|Other Pre-specified|Number of Participants With Event: Any Cancer|"Incidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization.~A single participant may have had multiple cancers."|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843388|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: Unknown Cause|Any death for which the cause is not known.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843389|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: External Cause|Fatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843390|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: Other Medical|Fatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843391|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: Respiratory|Fatal 'Respiratory' events include any death attributed to respiratory causes.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843392|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: Cancer|Fatal 'Cancer' events include any death attributed to cancer.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843393|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: Other Vascular|Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD).|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843394|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: All Stroke|Fatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction).|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843395|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: Coronary|Fatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease).|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843396|NCT00135226|Other Pre-specified|Number of Participants With Fatal Event: All-cause Mortality|'All-cause mortality' includes all recorded deaths.|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843397|NCT00135226|Secondary|Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only)|"Secondary efficacy assessments of aspirin involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of:~Any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up."|Randomized treatment phase during a mean of 7.4 years|Participants taking aspirin|||Participants|||Count of Participants
2843398|NCT00135226|Secondary|Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations|"Secondary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 versus placebo on the first occurrence of the expanded vascular endpoint of SVE or revascularization (including coronary and non-coronary revascularizations)."|Randomized treatment phase during a mean of 7.4 years|A single participant may have had multiple events.|||Participants|||Count of Participants
2843399|NCT00135226|Primary|Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)|"The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of any major bleed, defined as:~any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or~sight-threatening eye bleeding; or~any other serious bleeding episode."|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843400|NCT00135226|Primary|Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)|"The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any Serious Vascular Event (SVE), defined as:~non-fatal myocardial infarction; or~non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or~vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision [ICD-10] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage [I60], intracerebral hemorrhage [I61], and other non-traumatic intracranial hemorrhage [I62])."|Randomized treatment phase during a mean of 7.4 years||||Participants|||Count of Participants
2843401|NCT00135200|Secondary|Time to Treatment Failure|Of patients who initially responded (completely or partially) to treatment, at what subsequent point (measured in months) did they have progression of disease or begin a different treatment|up to approximately 15 years after treatment|||||||
2843402|NCT00135200|Secondary|Progression Free Survival Time|Disease progression or death from Multiple Myeloma from start of study treatment|up to approximately 15 years after treatment|||||||
2843403|NCT00135200|Secondary|Duration of Response|Progressive Disease (PD)-Free Interval (Duration of Response): measured, in a responder, from the date when a Complete Response, Complete Response, unconfirmed (CRu), or Partial Response (PR) is first noted to the first date at which progressive disease is observed. An ongoing PD-free interval occurs when there is a responder for whom progressive disease has not been noted.|up to approximately 15 years after treatment|||||||
2843477|NCT00134017|Secondary|Non-relapse Mortality|Percentage of participants who died for BMT-related reasons.|Day 100, 2 years|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. NRM data was not collected on the remaining 25 participants.|||percentage of participants||95% Confidence Interval|Number
2843404|NCT00135200|Secondary|Number of Participants With Complete Response (CR)|"Determine the rate of conversion to complete response (CR). CR requires all of the following:~Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.~Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation.~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).~Disappearance of all soft tissue plasmacytomas.~Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied."|6 months||||participants|||Number
2843405|NCT00135200|Primary|Percentage of Patients With an Objective Response|"The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level.~An objective response may be:~Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations.~Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations.~Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation."|3 months||||percentage of patients||95% Confidence Interval|Number
2843406|NCT00134901|Primary|Weekly Cocaine Use|Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.|weekly use during length of study participation||||days||Standard Deviation|Mean
2843407|NCT00134901|Secondary|Cocaine Abstinence Based on Daily Self Reported Cocaine Use|A binary indicator of sustained abstinence, defined as three consecutive weeks of no cocaine use, obtained by self-report and verified using negative urine toxicology results, at any point of the trial;|reported weekly cocaine use for 12 weeks/ or study participation|All analyses were performed on an intent-to-treat basis|||participants|||Number
2843408|NCT00134784|Primary|Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images|The use of SPECT to measure striatal dopamine-transporter density with the use of [123I]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.|40 weeks|Per protocol|||percent change of B-CIT Uptake|Participants|Standard Deviation|Mean
2843409|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age|Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.|||Participants|||Count of Participants
2843410|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From enrolment through the day preceding the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.|||Participants|||Count of Participants
2843411|NCT00134719|Secondary|Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine|Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.|During a 43-day (Day 0-42) after the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.|||Participants|||Count of Participants
2843412|NCT00134719|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.|||Participants|||Count of Participants
2843413|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after the fourth dose vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.|||Participants|||Count of Participants
2843478|NCT00134017|Secondary|Chimerism|Number of patients who achieved 100% donor chimerism.|Day 30, Day 60|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Chimerism data was not collected on the remaining 25 participants. One participant died prior to Day 30 and was not analyzed for this outcome.|||Participants|||Count of Participants
2843414|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.|||Participants|||Count of Participants
2843415|NCT00134719|Secondary|Anti-varicella Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2843416|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843417|NCT00134719|Secondary|Anti-mumps Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2843418|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843419|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|42 days after the fourth dose|Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843420|NCT00134719|Secondary|Anti-rubella Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
2843421|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843422|NCT00134719|Secondary|Anti-measles Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
2843423|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843424|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenY|Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843479|NCT00134017|Secondary|Days to Engraftment|Median number of days to neutrophil and platelet engraftment.|Up to one year|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Engraftment data was not collected on the remaining 25 participants. Recipients of related-donor (n=78) and unrelated-donor (n=39) transplants were reported separately.|||days||Full Range|Median
2843425|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenC|Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843426|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5|The cut-off value assessed was a titer of 1:5.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point|||Participants|||Count of Participants
2843427|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL|The cut-off value assessed was 4 IU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843428|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843429|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL|The cut-off value assessed was 150 mIU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843430|NCT00134719|Secondary|Anti-PRP Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2843431|NCT00134719|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843432|NCT00134719|Secondary|Anti-PSY Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2843433|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843434|NCT00134719|Secondary|Anti-PSC Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2843444|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-varicella Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
2843435|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843436|NCT00134719|Secondary|hSBA-MenY Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2843437|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843438|NCT00134719|Secondary|hSBA-MenC Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2843439|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843440|NCT00134719|Secondary|rSBA-MenY Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2843441|NCT00134719|Secondary|Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843442|NCT00134719|Secondary|rSBA-MenC Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||titer||95% Confidence Interval|Geometric Mean
2843443|NCT00134719|Secondary|Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843500|NCT00133952|Secondary|Time to Focal Photocoagulation||Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||months||95% Confidence Interval|Median
2843445|NCT00134719|Primary|Number of Subjects With an Anti-rubella Seroresponse|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
2843446|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-mumps Antibodies|"The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination.~ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent."|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
2843447|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-measles Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.|||Participants|||Count of Participants
2843448|NCT00134719|Primary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843449|NCT00134719|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.|||Participants|||Count of Participants
2843450|NCT00134563|Secondary|Changes From Baseline in Fatigue Impact Scale [FIS] Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||units on a scale||Standard Error|Least Squares Mean
2843451|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||mililiters (mL)||Standard Deviation|Mean
2843452|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, baseline EDSS stratum and baseline number of Gd-enhancing T1-lesions as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||lesions per scan||95% Confidence Interval|Number
2843453|NCT00134563|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||mililiters (mL)||Standard Deviation|Mean
2843475|NCT00134043|Primary|Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Up to 3 years|Per RECIST (Response Evaluation Criteria in Solid Tumors)|||percentage of participants|||Number
2843454|NCT00134563|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.~Probability of disability progression at 24, 48 and 108 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||percent probability||95% Confidence Interval|Number
2843455|NCT00134563|Primary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in EDSS score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).|||relapses per year||95% Confidence Interval|Number
2843456|NCT00134381|Secondary|Effect of 4-6% Caffeine on UVB-Induced Erythema|Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The erythema scores at 6, 8, and 24 hr post-UVB were averaged.|24 hr|Sixty-two (62) subjects received caffeine on one test site and placebo on the other site after exposure to 0.5-1.5 times individual subjects' minimal erythema dose (MED) of UVB.|||units on a scale||Standard Error|Mean
2843457|NCT00134381|Secondary|Effect of Green Tea Compounds on UVB-Induced Erythema|Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.|48 hrs|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.|||units on a scale||Standard Error|Mean
2843458|NCT00134381|Primary|Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells|The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).|||percentage of p-p53 (Ser15) pos. cells||Standard Error|Mean
2843459|NCT00134381|Primary|Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells|The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).|||percentage of caspase-3-positive cells||Standard Error|Mean
2843460|NCT00134381|Primary|"Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic Sunburn Cells"|"The percentage of apoptotic sunburn cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure."|48 hr|Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).|||"percentage of sunburn cells"||Standard Error|Mean
2843461|NCT00134381|Primary|"Change in UVB-Induced Apoptotic Sunburn Cells by Green Tea Compounds"|"The mean change in number of apoptotic sunburn cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure."|48 hr|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.|||cells/mm||Standard Error|Mean
2843476|NCT00134017|Secondary|Relapse|Percentage of participants who developed relapse or progressive disease.|2 years|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Relapse data was not collected on the remaining 25 participants.|||percentage of participants||95% Confidence Interval|Number
2843462|NCT00134381|Primary|Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds|The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.|48 hrs|Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.|||cells/mm||Standard Error|Mean
2843463|NCT00134082|Secondary|Days to Neutrophil and Platelet Engraftment|Median number of days to absolute neutrophil count (ANC) >= 500/mcL and platelet count >=20000/mcL.|Up to 46 days||||days||Full Range|Median
2843464|NCT00134082|Secondary|Survival|Median number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival).|Up to 6 years||||months||Full Range|Median
2843465|NCT00134082|Primary|Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells|Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells. Increase in frequency is defined as at least one order of magnitude higher than baseline measurement.|Change from 3 months to 6 months|Although the specimens were collected per protocol, they were not interpretable and therefore no data was collected to assess this outcome measure||||||
2843466|NCT00134082|Primary|Number of Participants With Grade 3-5 Adverse Events|Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention.|Up to 36 months||||Participants|||Count of Participants
2843467|NCT00134056|Other Pre-specified|Number of Patients With a Change in Functional Status|Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment.|up to 18 months study period||||Participants|||Count of Participants
2843468|NCT00134056|Other Pre-specified|Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)|"Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of 0 will be defined as stable if their WPS remains 0 for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment"|up to 18 months study period|There was a large amount of missing data points due to the difficulty of data collection of pain medication logs in addition to a questionnaire.The study team and site staff were only able to obtain complete data for the patients included in this analysis.|||Participants|||Count of Participants
2843469|NCT00134056|Secondary|Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.|Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Up to 52 weeks|450 (225 in each arm) of 461 patients with measurable disease at trial enrollment were assessable for response by RECIST.|||Participants|||Count of Participants
2843470|NCT00134056|Secondary|Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.|PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.|Up to 7 years after study opens||||Participants|||Count of Participants
2843471|NCT00134056|Secondary|Compare Qualitative and Quantitative Toxicity Between the Two Study Arms|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Assessed every 3 weeks up to 52 weeks|patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo|||Participants|||Number
2843472|NCT00134056|Secondary|Compare Pain Progression Between the Two Study Arms.|Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.|Up to 52 weeks|Only those patients who progressed on study were included in this analysis. The proportion of patients with pain progression is calculated using number of patients with pain progression as the numerator and the total number of patients who progressed on study as the denominator.|||Participants|||Count of Participants
2843473|NCT00134056|Primary|Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.|Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.|Up to 7 years after study opens||||months||95% Confidence Interval|Median
2843474|NCT00134056|Primary|Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.|Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.|Up to 7 years after study opens||||months||95% Confidence Interval|Median
2843480|NCT00134017|Primary|Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)|Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).|Day 100|The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. GVHD data was collected on 15 additional participants for a total of 132. GVHD data was not collected on the remaining 10 participants.|||Participants|||Count of Participants
2843481|NCT00134004|Secondary|Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation|Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.|1 year||||percentage of participants|||Number
2843482|NCT00134004|Secondary|Graft Failure Rate|Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.|Cumulative incidence for the entire study, up to 11 years||||percentage of participants|||Number
2843483|NCT00134004|Primary|Progression-free Survival|Percentage of participants who do not experience disease relapse, disease progression, or death.|2 years||||percentage of participants|||Number
2843484|NCT00134004|Primary|Relapse Rate|Percentage of participants who experience disease relapse.|Cumulative incidence for the entire study, up to 11 years||||percentage of participants|||Number
2843485|NCT00134004|Primary|Transplant-related Mortality|Percentage of participants who die for any reason other than recurrence of disease.|Cumulative incidence for the entire study, up to 11 years||||percentage of participants|||Number
2843486|NCT00133991|Secondary|Relapse Pattern|Percentage of participants experiencing central nervous system (CNS) and systemic relapse.|Up to 6 months|The 4 participants who died during treatment were not analyzed for this outcome.|||Participants|||Count of Participants
2843487|NCT00133991|Primary|Percentage of Participants Experiencing Grade 3-5 Toxicity|Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria).|Up to 2 years||||Participants|||Count of Participants
2843488|NCT00133991|Primary|Event-free Survival|Percentage of participants alive without relapse at 1 year and 3 years.|1 year and 3 years||||percentage of participants||95% Confidence Interval|Number
2843489|NCT00133991|Primary|Overall Survival|Percentage of participants alive at 1 year and at 3 years.|1 year and 3 years||||percentage of participants||95% Confidence Interval|Number
2843490|NCT00133991|Primary|Overall Response Rate|Number of participants who have a complete or partial remission (2007 International Working Group criteria).|Up to 3 months|The 4 participants who died during treatment were not analyzed for this outcome.|||Participants|||Count of Participants
2843491|NCT00133978|Secondary|Hospital Length of Stay|Measure of the duration of the participant's hospital stay|6 months (from ICU admission)||||days||Inter-Quartile Range|Median
2843492|NCT00133978|Secondary|ICU Acquired Infection|We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for 'Definite', 'Probable', and 'Possible' for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.|Day 28||||participants|||Number
2843493|NCT00133978|Secondary|ICU Length of Stay|Measure of the duration of participant stay in the ICU|Day 28||||days||Inter-Quartile Range|Median
2843494|NCT00133978|Primary|28-day Mortality|28-day mortality/status: at 28 days after randomization;|Day 28||||participants|||Number
2843495|NCT00133952|Secondary|Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24|Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||participants|||Number
2843496|NCT00133952|Secondary|Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||participants|||Number
2843497|NCT00133952|Secondary|Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.|||participants|||Number
2843498|NCT00133952|Secondary|Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula||Baseline, up to 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements, last observation carried forward (LOCF).|||micrometer (µm)||Standard Deviation|Mean
2843499|NCT00133952|Secondary|Change From Baseline to Month 24 in Contrast Sensitivity|Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline contrast sensitivity measurements.|||letters read correctly||Standard Error|Least Squares Mean
2843501|NCT00133952|Secondary|Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24|Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline macular edema measurements.|||Eyes|Participants||Number
2843502|NCT00133952|Secondary|Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula|Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements.|||micrometer (µm)||Standard Error|Least Squares Mean
2843503|NCT00133952|Primary|Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48|SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.|||percent of participants|||Number
2843504|NCT00133809|Secondary|The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels at 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months after islet cell transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation||||participants|||Number
2843505|NCT00133809|Secondary|Number of Subjects With HbA1C ≤ 6.5%|HbA1C was assessed in subjects 1, 3, 6, 9,12,18,24, 36, 48 and 60 months after transplantation and the number of subjects with values ≤ 6.5% was recorded which indicated better control of blood glucose levels.|1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation||||participants|||Number
2843506|NCT00133809|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months following islet transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation||||participants|||Number
2843507|NCT00133809|Primary|The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation|Independence from insulin injections is measured by the actual use of insulin by the study participants.|one year after transplant||||participants|||Number
2843508|NCT00133705|Primary|Uterine Volume|Uterine volume is measured in mLs|6 months||||mL||Standard Deviation|Mean
2843509|NCT00133575|Secondary|Assessment of Dryvax Take Category|"Restricted to participants who received Dryvax 6-15 months after MVA. A take is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction"|3 weeks after Dryvax challenge||||Participants|||Number
2843510|NCT00133575|Secondary|Peak Titer of Viral Shedding Post Dryvax Challenge|Median Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.|Until vaccination site lesion has scabbed||||Titers||Full Range|Median
2843511|NCT00133575|Secondary|Peak T-cell Gamma Interferon Responses (ELISPOT)|Median T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10^6 peripheral blood mononuclear cells (SFU/10^6 PBMC).|Approximately Day 42 after first vaccination||||SFU/10^6 PBMC||Inter-Quartile Range|Median
2843512|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to Vaccinia|Median binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
2843513|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to ACAM3000 MVA|Median binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
2843514|NCT00133575|Secondary|Peak Neutralizing Antibodies to Vaccinia|Median neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
2843515|NCT00133575|Secondary|Peak Neutralizing Antibodies to ACAM3000 MVA|Median neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination||||Titers||Inter-Quartile Range|Median
2843516|NCT00133575|Primary|Number of Participants With Signs of Possible Myopericarditis|Number of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study|Within 360 days after vaccination||||Participants|||Number
2843517|NCT00133575|Primary|Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination|Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination||||Participants|||Number
2843518|NCT00133575|Primary|Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination|Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions|28 days after vaccination||||Participants|||Number
2843519|NCT00133575|Primary|Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination|Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination||||Participants|||Number
2843520|NCT00133575|Primary|Number of Participants With Hematologic Laboratory Abnormalities After Vaccination|Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination||||Participants|||Number
2843521|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions|Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination||||Participants|||Number
2843522|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Local Reactions|Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination||||Participants|||Number
2843523|NCT00132964|Secondary|Health Economic Outcomes|parent reported costs and health care system costs|12 weeks|||||||
2843524|NCT00132964|Secondary|Range of Motion at 4 Weeks|Goniometer measured by a physiotherapist|4 weeks|||||||
2843525|NCT00132964|Secondary|Pain at 4 Weeks|Bieri Face Pain Scale. This is scored as 0, 2, 4, 6, 8, 10. Higher scores indicate more pain.|4 weeks||2019-09-30|09/2019||||
2843526|NCT00132964|Primary|Functional Outcome as Measured by the Activities Scale for Kids at 4 Weeks From the Time of the Initial Injury|Activities Scale for Kids (ASKp) measured by a physiotherapist at 4 week visit and is a validated 38-questionnaire that targets activities of children. The minimal scores are 0 and maximum are 100. Higher score indicates higher function.|4 weeks||||percentage of questions||Standard Error|Mean
2843527|NCT00132873|Primary|Vital Signs|Average Respiratory Rate at 1 year.|At 1 year||||Breaths per minute||Standard Deviation|Mean
2843528|NCT00132873|Primary|Adverse Experiences|Number of Subjects with treatment-emergent adverse events.|continuous||||participants|||Number
2843529|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum|Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.|||ng/mL||Standard Deviation|Mean
2843530|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum|Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.|||ng/mL||Standard Deviation|Mean
2843531|NCT00132808|Secondary|Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum|Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.|||ng/mL||Standard Deviation|Mean
2843532|NCT00132808|Secondary|Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.|||Percentage change in BMD||Standard Error|Least Squares Mean
2843533|NCT00132808|Secondary|Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.|||Percentage change in BMD||Standard Error|Least Squares Mean
2843534|NCT00132808|Primary|Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum|The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).|Baseline, Month 24|Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data.|||Percentage change in BMD||Standard Error|Least Squares Mean
2843535|NCT00132769|Secondary|Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein|C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.|||ratio||95% Confidence Interval|Least Squares Mean
2843536|NCT00132769|Secondary|Patient's Assessment of Pain|"At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from No pain (0) to Extreme pain (100). A lower score indicates less pain."|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
2843537|NCT00132769|Secondary|Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
2843538|NCT00132769|Secondary|Patient Global Assessment of Response to Therapy|Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
2843539|NCT00132769|Secondary|Investigator Global Assessment of Disease Activity|At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
2843540|NCT00132769|Secondary|Patient Global Assessment of Disease Activity|"At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing. The VAS ranges from Very Well (0) to Very Poor (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity."|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
2843541|NCT00132769|Secondary|Change From Baseline in Tender Joint Count|Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.||||||
2843542|NCT00132769|Secondary|Percentage of Participants With American College of Rheumatology 20% Response [ACR20]|Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.|||percentage of participants|||Number
2843543|NCT00132769|Primary|Change From Baseline in Swollen Joint Count|Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|The All Patients Treated (APT) population consisted of all participants with a baseline and at least one postbaseline observation.|||score on a scale||95% Confidence Interval|Least Squares Mean
2843544|NCT00132730|Secondary|Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)|FVC is a measure, in liters and using a spirometer, of the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. The values averaged during the placebo run-in period were used for the baseline measurement and the values averaged over Treatment Weeks 8, 10 and 12 were used for the on-treatment measurement. A higher value indicates greater lung exiratory function.|Predose at Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||liters||95% Confidence Interval|Least Squares Mean
2843545|NCT00132730|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration (at investigator's discretion) of systemic corticosteroids (above participant's usual dose) and/or antibiotics, or an unscheduled COPD-related hospitalization, emergency room visit, or doctor visit. The number of participants who experienced at least one COPD exacerbation during the 12-week treatment period is reported.|Baseline through Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||participants|||Number
2843546|NCT00132730|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response|The SOBQ is a validated 24-item measure of dyspnea associated with activities of daily living in patients with moderate to severe chronic lung disease. Twenty-one items ask patients about how frequently they experience shortness of breath (SOB) on a 6-point scale of 0 (never) to 5 (activity given up due to dyspnea) when performing various tasks. Three additional questions about limitations due to SOB, fear of harm from overexertion and fear of SOB are included for a total of 24 items. If patients do not routinely perform the activity indicated in the questionnaire, they are asked to estimate the degree of SOB anticipated. The SOBQ total score is calculated by summing responses across all 24 items. The total score ranges from 0 to 120, with a higher score indicating greater frequency of and limitations due to SOB. The score assessed at the baseline visit was used for the baseline score and the mean score assessed at Treatment Weeks 8 and 12 was used as the on-treatment score.|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
2843547|NCT00132730|Secondary|Transition Dyspnea Index (TDI) Focal Score|The baseline dyspnea index (BDI) was measured at the randomization visit as a 3-domain score with a scale of 0 to 4 in each domain, with a total focal score of 12 indicating no dyspnea limitation and 0 indicating severe dyspnea. After 12 weeks of treatment, the investigator-administered TDI was completed, with a change in each of the 3 domains being rated from -3 (major deterioration) to +3 (major improvement), so that the TDI focal score could range from -9 to +9. A higher TDI focal score indicates improvement.|Baseline and Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
2843548|NCT00132730|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response|"The SGRQ consists of 76 items in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impacts (social functioning, psychological disturbances resulting from airways disease). Scores for each domain and a total score are calculated; each questionnaire response has a unique empirically dervied weight. Scores range from 0 to 100, with higher scores indicating poor health. Each domain of the questionnaire is scored separately in 2 steps: 1) The weights for all items with a positive response are summed; 2) The score is calculated by dividing the summed weights by the maximum possible weight for that domain and expressing the results as a percentage. The mean SGRQ scores were calculated during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
2843549|NCT00132730|Secondary|Change From Baseline in Total Daily Beta-agonist Use|The total daily beta-agonist use was measured in puffs per day and was recorded on daily diary cards by participants. It is defined as the sum of beta-agonist use between when participants arose from and went to bed. The total daily beta-agonist use values were the recorded mean during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||Puffs per day of beta-agonist||95% Confidence Interval|Least Squares Mean
2843550|NCT00132730|Secondary|Change From Baseline in Overall Daytime Symptoms Score|"On a daily diary card, participants rated their responses to the question Overall, how much of the time did you have symptoms from your lung disease today? (0=none of the time; 5=all of the time). Scores range from 0 to 5, with higher scores indicating more time with symptoms. The overall daytime symptoms score value was the mean daily diary score during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.|||score on a scale||95% Confidence Interval|Least Squares Mean
2843551|NCT00132730|Primary|Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.|Pre-dose at Baseline and Treatment Weeks 8, 10 and 12|The modified intention-to-treat (ITT) population includes all participants who had a baseline and at least one posttreatment measurement.|||liters||95% Confidence Interval|Least Squares Mean
2843552|NCT00132691|Secondary|Mortality||24 months||||percentage of participants||95% Confidence Interval|Number
2843553|NCT00132691|Secondary|Diabetes Mellitus||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.|||percentage of participants||95% Confidence Interval|Number
2843554|NCT00132691|Secondary|Hypertension Diagnosis Requiring Treatment||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.|||percentage of participants||95% Confidence Interval|Number
2843555|NCT00132691|Secondary|Hyperlipidemia - Incident|LDL greater than or equal to 160 mg/mL|24 months|Number of participants at risk were included in the analysis|||percentage of participants at risk||95% Confidence Interval|Number
2843556|NCT00132691|Secondary|Change in SF-36 Physical Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.|24 months||||units on a scale||Standard Error|Mean
2843557|NCT00132691|Secondary|Change in SF-36 Mental Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.|24 months||||units on a scale||Standard Error|Mean
2843558|NCT00132691|Secondary|Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months|The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.|24 months||||units on a scale (composite score)||Standard Error|Mean
2843559|NCT00132691|Secondary|Cataract - Incident Cataract||24 months|Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843560|NCT00132691|Secondary|Intraocular Pressure - IOP-lowering Surgery||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843561|NCT00132691|Secondary|Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.|The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843562|NCT00132691|Secondary|Glaucoma - Incident|Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843563|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843564|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843565|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.|||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
2843566|NCT00132691|Secondary|Uveitis Activity|Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy).|||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
2843567|NCT00132691|Secondary|Macular Edema|center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy)..|||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
2843568|NCT00132691|Primary|Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis|Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.|24 months|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 255 randomized participants were used in the analytic model. 232 of the 255 completed the 2 year outcome visit."|||letters||Standard Error|Mean
2843569|NCT00132678|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS)|Measure of depression; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)|||units on a scale||Standard Deviation|Mean
2843570|NCT00132678|Secondary|Change in Young Mania Rating Scale (YMRS) Scores.|Measure of mania; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)|||units on a scale||Standard Deviation|Mean
2843571|NCT00132678|Primary|Number of Participants Who Had a Mood Relapse.|"Mood Relapse was defined as:~The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score >12 or a CGI-S score >4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator."|24 months|Intention to treat. 28 subjects from a Good Clinical Practice noncompliant site and 1 site with alleged research misconduct were excluded from efficacy analyses. The median (interquartile range) for time to relapse (d): Risperdal Consta: NA (173, NA) & Placebo: 219 (82, NA) [NA = not available; Risperdal Consta relapse percent < 50% & Placebo <75%]|||Participants|||Number
2843572|NCT00132496|Primary|Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group|Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.|8 weeks from randomization and end of treatment|Safety population (all patients who received at least one dose of study treatment) was the primary analysis population.|||Participants|||Number
2843573|NCT00132314|Primary|Hazard Ratio for Hospitalization|Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.|24 months||||participants|||Number
2843574|NCT00132314|Primary|Hospitalization-free Survival - Time to Event|A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.|From randomization until date of first re-hospitalization, assessed up to 24 months||||years||95% Confidence Interval|Median
2843575|NCT00132301|Primary|Number of Participants With Progression-Free Survival|The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.|Up to 100 months (centralized follow-up)|One participant in Arm 1 was excluded from analysis by the Data Monitoring Committee (DMC), making the analysis population in Arm 1 140 participants.|||Participants|||Count of Participants
2843576|NCT00132132|Primary|Percentage of Participants With BMI Reduction||Baseline, 12-15 months|Per protocol|||percentage of participants|||Number
2843579|NCT00132028|Secondary|Progression-Free Survival|Measured from date of registration to date of first observation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing progression-free survival.|||months||95% Confidence Interval|Median
2843580|NCT00132028|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|after every 3 cycles on treatment|All patients who started treatment were included in assessing response estimates.|||participants|||Number
2843581|NCT00132002|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment to the time of documented progression, assessed up to 5 years||||Months||95% Confidence Interval|Median
2843582|NCT00132002|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From the initial date of treatment to time of death, up to 5 years.||||Months||95% Confidence Interval|Median
2843583|NCT00132002|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 8 weeks||||percentage of participants|||Number
2843584|NCT00131937|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.||||months||90% Confidence Interval|Median
2843585|NCT00131937|Secondary|Progression-Free Survival (PFS)|"PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as:~Appearances of any new lesions/sites during or after therapy~Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site~Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node >1.0 cm in its short axis"|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years||||months||90% Confidence Interval|Median
2843586|NCT00131937|Primary|Overall Response (OR) Rate|"Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass >1.5 cm in greatest diameter that has decreased by >75%. Indeterminate bone marrow.~PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites."|Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.||||Proportion of participants||90% Confidence Interval|Number
2843587|NCT00131911|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from attaining a response (PR or CR) to the date of progression. Participants without progression were censored at the date of their most recent disease assessment. The median DOR was estimated using simple summary statistics.|Time from response to progression (up to 2 years)|There were 4 confirmed responses in Group A and 5 confirmed responses in Group B used in analyzing this endpoint.|||months||Full Range|Median
2843588|NCT00131911|Secondary|Progression Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST) as a 20% increase in the su of longest diameter of target lesions. Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Participants who were progression free were censored at the date of their most recent disease assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 2 years)||||months||95% Confidence Interval|Median
2843589|NCT00131911|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|From registration to death (up to 2 years)||||months||95% Confidence Interval|Median
2843590|NCT00131911|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of participants reporting a grade 3 or higher toxicity are reported.|Up to 2 years||||participants|||Number
2843591|NCT00131911|Primary|Confirmed Response Rate|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. > > Complete Response (CR) is defined as the disappearance of all target lesions. > Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions; >~> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method."|Duration of Treatment (Up to 2 years)|Nine of the 50 carcinoid patients and 6 of the 42 Islet cell patients did not continue treatment past cycle 1. Therefore, these patients were not evaluated on consecutive cycles and were excluded from this endpoint.|||percentage of participants||95% Confidence Interval|Number
2843592|NCT00131885|Secondary|Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||IU/mL||Standard Deviation|Mean
2843593|NCT00131885|Secondary|Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||pg/mL||Standard Deviation|Mean
2843594|NCT00131885|Primary|Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.|Average and standard deviation for Clearance (L/hr) of Levonorgestrel study for each dosage group and each study session.|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||L/hr||Standard Deviation|Mean
2843595|NCT00131885|Secondary|Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)||||IU/mL||Standard Deviation|Mean
2843596|NCT00131885|Primary|Number of Participants With Progesterone Levels Above 3.0 ng/ml at Time 1 (Baseline) and Time 2 (After Intervention With St John's Wort or Placebo).|"Serum progesterone levels were drawn at the time of dosing with levonorgestrel and then at weekly intervals until menses occurred. This was done at Time 1 (baseline), and again at Time 2 (after 5 weeks of dosing with St. John's Wort or placebo).~Possible ovulation was defined as a serum progesterone >3ng/ml within 2 weeks of Days 9-12 of the menstrual cycle."|Progesterone levels drawn at weekly intervals after dosing with levonorgestrel between Days 9 and 12 of the menstrual cycle, at each time point until menses||||Participants|||Number
2843597|NCT00131885|Primary|Area Under the Concentration Versus Time Curve for 0 to 24 Hours After Drug Administration, Done Between Days 9 and 12 of the Menstrual Cycle at Time 1 (Before) and Time 2 (During Treatment With St. John's Wort or Placebo)|"Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Serum samples drawn at 0, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, and 24 hours, following oral administration of a dose of levonorgestrel.~Treatment between the two time periods was with St. John's Wort or placebo herb, beginning after the Time 1 (baseline) and continued for 5 weeks until Time 2.~Estimates of levonorgestrel clearance were made using a two stage non-compartmental approach to determine individual and group parameters."|Area Under the Concentration versus Time curve for 0 to 24 hours after drug administration, between Days 9 and 12 of the menstrual cycle, done at Time 1 and at Time 2||||ng*hr/mL||Standard Deviation|Mean
2843598|NCT00131677|Other Pre-specified|>5% Bone Mineral Density Decline at Femoral Neck|Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug. In addition, this analysis population includes only those participants for whom bone density analyses were performed.|||percentage of participants|||Number
2843599|NCT00131677|Primary|Clinical Safety--Hypophosphatemia|Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.|||participants|||Number
2843600|NCT00131677|Secondary|Behavioral Safety--Unprotected Anal Sex (UAS)|Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.|Nine months||||percentage of ppts reporting UAS|||Number
2843601|NCT00131677|Secondary|Adherence to Study Drug|Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.|24 months (immediate arm) and 15 months (delayed arm)||||percentage of doses|||Number
2843602|NCT00131677|Secondary|Number of Breakthrough HIV Infections|Number of participants with HIV seroconversions occuring while on study drug|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.|||participants|||Number
2843627|NCT00131508|Secondary|Change in Height Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height percentile in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Percentile||Full Range|Median
2843603|NCT00131677|Primary|Clinical Safety--Creatinine Elevations|Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined. Participants entered the TE cohort with first dispense and exited with the first occurrence of: (1) completion of follow-up, (2) 30 days after permanent drug interruption, or (3) 30 days after last visit. For delayed arm participants,time before initiation of drug was excluded.|||Participants|||Number
2843604|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||µg/mL||Standard Error|Mean
2843605|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||microgram per millilitre (µg/mL)||Standard Error|Mean
2843606|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. CRP was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||mg/dL||Standard Deviation|Mean
2843607|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. CRP was only done at baseline, months 6 and 8. The test was optional and performed only by participating sites.|Baseline and Month 6|All Primary and secondary endpoints were calculated on the Intent to Treat (ITT) population where each patient had at least one dose of the medication and at least one valid observation. Missing values were carried forward (using Last Observation Carried Forward method) except for the calculation of the composite variables.|||milligram per decilitre (mg/dL)||Standard Error|Mean
2843608|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12|"Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2. The UKPDS (U.K. Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to HDL ratio at a specified visit.~The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||percent||Standard Error|Mean
2843609|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6|"Change from baseline was calculated as the Month 6 value minus the baseline value, with LOCF from Month 2. The UKPDS (United Kingdom Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) ratio at a specified visit.~The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||percent||Standard Error|Mean
2843610|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 12|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||participants|||Number
2843611|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 6|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||participants|||Number
2843612|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 4|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||participants|||Number
2843628|NCT00131508|Secondary|Change in Height Z-score From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height Z-score in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Z-score||Full Range|Median
2843613|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||millimoles per litre (mmol/L)||Standard Error|Mean
2843614|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.|||millimoles per litre (mmol/L)||Standard Error|Mean
2843615|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||millimoles per litre (mmol/L)||Standard Error|Mean
2843616|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 12|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||participants|||Number
2843617|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 6|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline Month 6 were analyzed.|||participants|||Number
2843618|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 4|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||participants|||Number
2843619|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.|||percent||Standard Error|Mean
2843620|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.|||percent||Standard Error|Mean
2843621|NCT00131664|Primary|Mean Change From Baseline in A1C at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with a value at baseline and at Month 6 were analyzed.|||percent||Standard Error|Mean
2843622|NCT00131573|Primary|Freedom From Major Complications||5 years||||Number of Adverse Events|||Number
2843623|NCT00131573|Primary|Average Number of Voids Per Day||12 months||||Average Number of Voids||Standard Deviation|Median
2843624|NCT00131508|Secondary|Change in Hand Grip From Baseline to 12 Months.|"To investigate the clinical effects of oral glutamine and placebo on hand grip in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.~Hand grip strength is a measure of muscle strength.Units are measured in Kg.Muscle strength is measured using a hydraulic hand-held dynamometer.Change was defined as 12 Month measure minus baseline.Muscle strength is measured using the hand grip strength via a hydraulic hand-held dynamometer (Kg)."|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||kg||Full Range|Median
2843625|NCT00131508|Secondary|Change in Pulse Rate From Baseline to 12 Months|To investigate the clinical effects of oral glutamine and placebo on pulse rate in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Beats per minute (BPM)||Full Range|Median
2843626|NCT00131508|Secondary|Change in Weight Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on weight in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Basline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.|||Percentile||Full Range|Median
2845372|NCT00116779|Secondary|Median Testosterone Levels at Various Days During the Study|Testosterone levels at baseline and days 1, 3, 7, 14 and 364|Baseline, Days 1,3,7,14,364|ITT population|||nanograms / milliliter||Full Range|Median
2843629|NCT00131508|Secondary|Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports.|Evaluation of quality of life at baseline and 12 months in the glutamine versus placebo group using the PedsQL Version 4.0 inventory. This instrument measures individual well being across physical, emotional, social, and school function categories using patient self-reports and/or parent reports. The tool contains a 15-question, age-specific, self-report inventory (for children age 5-7 years, 8-12 years, and 13-18 years) and a corresponding parent inventory. Lower scores indicate a better quality of life.|Baseline and 12 Months||||Units on a scale||Full Range|Median
2843630|NCT00131508|Secondary|Change in Red Blood Cell Glutamine From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo in children with Sickle Cell Anemia (SCA) by comparing the difference in the levels of red blood cell glutamine between baseline and 12 months of treatment in the two groups.|Baseline and 12 months||||nmol/mg creatinine||Full Range|Median
2843631|NCT00131508|Secondary|Change in Body Mass Index From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMI) between baseline and 12 months of treatment in the two groups.|Baseline and 12 months||||kg/m2||Full Range|Median
2843632|NCT00131508|Primary|Change in Resting Energy Expenditure From Baseline to 12 Months|To compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months. REE was measured by indirect calorimetry, using a metabolic cart.REE Ratio =(REE Measured/REE Predicted)x 100).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.The REE Ratio was evaluated at baseline and 12 months.The REE Ratio is calculated as (REE Measured / REE Predicted) x 100).REE units are measured as (Kcal / day).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.|Baseline and 12 months||||REE ratio||Full Range|Median
2843633|NCT00131469|Secondary|Total Hip BMD|bone density by dual energy xray absorptiometry|baseline and 18 months||||percentage of change in g/cm2||Standard Error|Mean
2843634|NCT00131469|Primary|Spine Bone Mineral Density (BMD)|bone density by dual energy xray absorptiometry|baseline and 18 months||||percentage of change in g/cm2||Standard Error|Mean
2843635|NCT00131456|Primary|Two Consecutive Weeks of Marijuana Abstinence|The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.|measured daily by self report for 12 weeks of the trial or length of study participation|All analyses were conducted based on the intent-to-treat principle.|||participants|||Number
2843636|NCT00131378|Primary|Abdominal Fat|6 month change in visceral abdominal fat (primary body composition endpoint)|Measured at baseline and month 6||||cm^2||Standard Error|Mean
2843637|NCT00131378|Primary|Total Abdominal Fat|6 month change in total abdominal fat (primary body composition endpoint)|Measured at baseline and month 6||||cm^2||Standard Error|Mean
2843638|NCT00131378|Secondary|Insulin-like Growth Factor-1 (IGF-1) Levels|6-month change in IGF-1 levels|Measured at baseline and month 6||||ng/mL||Standard Error|Mean
2843639|NCT00131378|Secondary|Measure of Insulin Resistance|6 month change in 2-hour glucose (primary insulin resistance endpoint)|Measured at baseline and month 6||||mg/dL||Standard Error|Mean
2843640|NCT00131378|Primary|HsCRP|6 month change in HsCRP (primary cardiovascular risk endpoint)|Measured at baseline and month 6|ITT|||mg/L||Standard Error|Mean
2843641|NCT00131365|Post-Hoc|Number of Subjects With Adverse Events|Adverse events outcomes are reported in the adverse events module.|36 months||||Participants|||Count of Participants
2843642|NCT00131365|Primary|Number and Type of Adverse Events|Adverse events outcomes are reported in the adverse events module.|36 months|Adverse events outcomes are reported in the adverse events module.|||Adverse Events|||Number
2843643|NCT00131352|Secondary|Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26|"Participants were classified as a positive responder if at least one of the following two conditions were met:~A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR~Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU"|Week 26|Intent-To-Treat (ITT) population.|||participants|||Number
2843644|NCT00131352|Secondary|Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26|The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population|||participants|||Number
2843645|NCT00131352|Secondary|Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26|The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population|||participants|||Number
2843646|NCT00131352|Secondary|Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, Week 26|Intent-To-Treat (ITT) population.|||units on a scale||Standard Error|Mean
2843703|NCT00130117|Secondary|Bone Markers - Ctx and Sclerostin||36 weeks|Only for subjects participating in both phase A and phase B (n=4), bone markers were assessed to see the change over 24 month period. All these patient got metreleptin treatment|||ng/mL||Inter-Quartile Range|Median
2843647|NCT00131352|Secondary|Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, up to week 26|Intent-To-Treat (ITT) population.|||units on a scale||Standard Error|Mean
2843648|NCT00131352|Secondary|Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale|Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.|Week 26|Intent-To-Treat (ITT) population|||participants|||Number
2843649|NCT00131352|Secondary|Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.|Day 0, Week 26|Intent-To-Treat (ITT) population.|||units on a scale||Standard Error|Mean
2843650|NCT00131352|Primary|Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.|Day 0, up to week 26|Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.|||units on a scale||Standard Error|Mean
2843651|NCT00131248|Primary|Bradycardia Episodes/Day||7 days|18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed.|||episodes per day||Standard Deviation|Mean
2843652|NCT00130923|Secondary|Number of Participants With Medication Adherence|Number of participants with medication adherence (defined as taking medication at least 75% of the days in the treatment period).|6 months||||Participants|||Count of Participants
2843653|NCT00130923|Secondary|Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy)|A rater assesses social, occupational and psychological functioning on a hypothetical continuum of mental health - illness (using Global Assessment of Functioning); scores range from 100 to 1, where higher values represent a better outcome. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|6 months||||ordinal severity of impairment||95% Confidence Interval|Number
2843654|NCT00130923|Secondary|Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy)|A rater assesses positive and negative symptoms of schizophrenia using a 30-item scale (Positive and Negative Symptom Score) Scores range from 30 to 210, where higher values represent a worse outcome. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|6 months||||ordinal severity of symptoms||95% Confidence Interval|Number
2843655|NCT00130923|Secondary|Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy)|A rater assesses the severity of illness and global impression using a scale from 1 to 7 (Clinical Global Impression), where higher values represent a worse outcome. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|6 months||||ordinal unit of severity||95% Confidence Interval|Number
2843656|NCT00130923|Secondary|Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy)|Frequency of drinking days is obtained each week retrospectively as the number of drinking days during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|6 months||||drinking days per week||95% Confidence Interval|Number
2843657|NCT00130923|Primary|Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)|Frequency of heavy drinking days is obtained each week retrospectively as the number of heavy drinking days during the prior week (assessed by the Timeline Followback Scale). A heavy drinking day is defined as 4 or more drinks per day for a female and 5 or more drinks per day for a male. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|6 months||||heavy drinking days per week||95% Confidence Interval|Number
2843704|NCT00130117|Primary|the Difference Between the Placebo and Leptin Treated Groups in the Change in Bone Mineral Content(BMC) at the Anteroposterior (AP) Spine From Baseline to 36 Weeks||36 weeks||||g||Full Range|Mean
2843658|NCT00130832|Primary|Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered|Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|"Per Protocol Population~For serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350"|||GMT||95% Confidence Interval|Geometric Mean
2843659|NCT00130832|Primary|GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered|Approximately 42 days Postdose 3|Per Protocol Population|||GMT||95% Confidence Interval|Geometric Mean
2843660|NCT00130832|Primary|Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3|GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values.|||Geometric Mean Titer (GMT)||95% Confidence Interval|Geometric Mean
2843661|NCT00130793|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2843662|NCT00130793|Secondary|Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|4 weeks|All vaccinated subjects with safety follow-up are included.|||Participants|||Number
2843663|NCT00130793|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.|4 weeks|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2843664|NCT00130780|Primary|The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment.|These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas|2 years||||participants|||Number
2843665|NCT00130728|Secondary|Duration of Objective Response|Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.|Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)|Patients with an objective response|||months||95% Confidence Interval|Median
2843666|NCT00130728|Secondary|Percentage of Participants With Objective Response|Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.|The median duration of Objective response was up to 9.7 months|Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.|||Percentage of participants||95% Confidence Interval|Number
2843667|NCT00130728|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.|From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)|Randomized patients|||months||95% Confidence Interval|Median
2843668|NCT00130728|Primary|Overall Survival (OS) Among All Randomized Patients|Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.|From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)|Randomized patients|||months||95% Confidence Interval|Median
2843705|NCT00130039|Secondary|Numbers of Fatal or Major Bleeding Complications|life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|upto 7 months after randomization|this outcome analysis was done ITT method|||events|||Number
2845373|NCT00116779|Secondary|Median Luteinizing Hormone Levels at Various Study Timeframes|Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.|Baseline, Days 1, 3, 7, 14|ITT population|||international units / liter||Full Range|Median
2843669|NCT00130689|Primary|Overall Response Rate|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks).|Responses were determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|||proportion of paticipants||90% Confidence Interval|Number
2843670|NCT00130637|Primary|Number of Participants Reporting a Serious Adverse Event (SAE)|Safety of acute daclizumab use in JIA-associated uveitis was assessed through serious adverse events (SAE).|52 weeks||||participant|||Number
2843671|NCT00130637|Primary|Number of Participants With a Two-step Reduction in Inflammation|Number of participants with a two-step reduction (or down to 0 out of a scale of 0 to 4+) of anterior chamber (AC) inflammation according to Standardization of Uveitis Nomenclature (SUN) criteria, while on a topical corticosteroid schedule of less than 3 times a day. Grade 0 is the best score on this scale with <1 cell in the field and 4+ is the worst score on this scale with >50 cells in the field.|12 weeks||||participants|||Number
2843672|NCT00130533|Secondary|The Number of Participants Who Experienced Adverse Events (AE)|Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).|5 years|The analysis of toxicity was made in all study patients who had received at least 1 treatment cycle, or who had completed the observation period equivalent to 1 cycle.|||Participants|||Count of Participants
2843673|NCT00130533|Secondary|Overall Survival (OS) Event|OS event is defined as the death from any cause.|5 years||||Participants|||Count of Participants
2843674|NCT00130533|Secondary|Disease Free Survival (DFS) Events by Phenotype|DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.|5 years||||Participants|||Count of Participants
2843675|NCT00130533|Primary|Disease Free Survival (DFS) Events|DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.|5 years||||Participants|||Count of Participants
2843676|NCT00130520|Primary|Median Response Duration (Weeks)|Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration)|1 week to 96 weeks|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.|||weeks||Full Range|Median
2843677|NCT00130520|Secondary|Progression Free Survival(PFS)|PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause;|June 2005 to October 5, 2009|The population analyzed included all participants receiving at least 1 dose of study intervention and at least one assessment post-baseline. One subject was not evaluable. Analysis was per protocol|||months||Full Range|Median
2843678|NCT00130520|Primary|Objective Response (Complete Partial, Stable and Progression)|Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria|06.16.2005 to 10.05.2009|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.|||Participants|||Number
2843679|NCT00130286|Secondary|Change in Subcutaneous Adipose Tissue Volume|"Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI~Data are presented only for subjects who had MRI scans done at both time points."|12 weeks||||L||Standard Deviation|Mean
2843680|NCT00130286|Secondary|Change in Visceral Adipose Tissue Volume|"Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI~Data are presented only for subjects who had MRI scans done at both time points."|12 weeks||||L||Standard Deviation|Mean
2843681|NCT00130286|Primary|Change in Insulin Sensitivity|"Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test~This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points."|12 weeks||||uU*10^-4*min*ml^-1||Inter-Quartile Range|Median
2843682|NCT00130247|Secondary|Microbiologic: Time After Inoculation Until Culture Positive in BACTEC 460 or MGIT 960 Enriched Liquid Media After 2 Months in Treatment - Results Are Pending||Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 24, and 30|||||||
2843706|NCT00130039|Secondary|Number of Patients With Ipsilateral Ischemic Stroke Rate|ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis|upto 7 months after randomization|this outcome analysis was done ITT method|||participants|||Number
2843683|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.|||Participants|||Number
2843684|NCT00130247|Secondary|Microbiologic: Changes in Sputum Mycobacterial mRNA - Results Are Pending||At 1 and 2 months of anti-TB treatment, and upon relapse|||||||
2843685|NCT00130247|Secondary|Immunologic: Changes in Sputum Cytokine Levels - Results Are Pending||After 1 and 2 months of anti-TB treatment|||||||
2843686|NCT00130247|Secondary|Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) - Results Are Pending||Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis|||||||
2843687|NCT00130247|Secondary|Immunologic: Changes in Cytokine Levels in Mycobacterium Tubercolosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants - Results Are Pending||After 2 and 6 months of anti-TB treatment and upon relapse|||||||
2843688|NCT00130247|Secondary|Acquired Drug Resistance in Patients Who Relapsed||2 years|This analysis was per protocol and looked for acquired drug resistance among the 13 patients in the 4-Month Arm who relapsed and the 3 patients in the 6-Month Arm who relapsed.|||Participants|||Number
2843689|NCT00130247|Secondary|Relapses at 1 and 2 Years||1 and 2 years after successful completion of initial anti-TB treatment|Analysis includes the 386 patients who received the intervention, completed treatment, and started post-treatment follow-up (193 patients in each treatment arm). Two subjects were lost after completing treatment and contributed no follow-up time, and 6 subjects did not receive the intervention so were not included in the analysis.|||Participants|||Number
2843690|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.|||Participants|||Number
2843691|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.|||Participants|||Number
2843692|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.|||Participants|||Number
2843693|NCT00130208|Secondary|Change in Serum Albumin From Baseline to End of 26 Weeks||26 Weeks|Participant numbers include those with both baseline and week 26 measurements|||percent change||Standard Error|Least Squares Mean
2843694|NCT00130208|Primary|Number of Subjects With Greater Than 50% Reduction in Microalbuminuria|During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved.|26 Weeks||||Participants|||Count of Participants
2843695|NCT00130208|Primary|Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria|"The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom therapeutic success was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline"|26 Weeks||||Participants|||Count of Participants
2843696|NCT00130117|Secondary|Hip BMD||9months||||g/cm2||Inter-Quartile Range|Median
2843697|NCT00130117|Secondary|Radial BMD||9 months||||g/cm2||Inter-Quartile Range|Median
2843698|NCT00130117|Secondary|Lumbar BMD||9 months||||g/cm2||Inter-Quartile Range|Median
2843699|NCT00130117|Secondary|Total Body BMD||9 months||||g/cm2||Inter-Quartile Range|Median
2843700|NCT00130117|Secondary|Body Fat||36 weeks||||fat %||Standard Error|Mean
2843701|NCT00130117|Secondary|Total Body BMD||36 weeks||||g/cm^2||Inter-Quartile Range|Median
2843702|NCT00130117|Secondary|Body Composition BMI||36 weeks||||BMI-kg/m^2||Standard Error|Mean
2843707|NCT00130039|Secondary|Number of Participants With Overall Cardiovascular Events|including nonfatal stroke, nonfatal myocardial infarction and vascular death.|upto 7 months after randomization|this outcome analysis was done intention to treat method|||participants|||Number
2843708|NCT00130039|Secondary|Number of Participants With Stroke Events|including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke|upto 7 months after randomization|this outcome analysis performed on the intention to treat (ITT) method|||participants|||Number
2843709|NCT00130039|Secondary|Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI|number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI.|7 months after treatment|this analysis included the patients who had performed follow-up FLAIR imaging|||pariticipants|||Number
2843710|NCT00130039|Primary|Number of Participants With Progression of Symptomatic Intracranial Stenosis|"Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA.~The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA."|7 months after treatment||||participants|||Number
2843711|NCT00129987|Secondary|Number of Participants With Use of Asthma Medication|Number of participants with courses of steriod tablets|1 year|Less participants number due to missing data.|||Participants|||Count of Participants
2843712|NCT00129987|Secondary|Quality of Life Questionnaires|(MISS-21) with Quality of life questionnaires|1 year|Data not collected||||||
2843713|NCT00129987|Secondary|Lung Function|(peak flow measurement)|1 year|Data not collected||||||
2843714|NCT00129987|Primary|Number of Participants With Unscheduled Use of Healthcare|Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP|1 year|Less participants number due to missing data.|||Participants|||Count of Participants
2843715|NCT00129974|Secondary|Number of Participants With at Least One Adverse Event|Number of Participants with at least one Adverse Event|Study Termination|||||||
2843716|NCT00129974|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Study Termination|||||||
2843717|NCT00129961|Secondary|Spot Urine Protein:Creatinine Ratio|Subjects' urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. Available data, no imputations.|||ratio (mg/mg)||Full Range|Median
2843718|NCT00129961|Secondary|Number of Subjects With Biopsy-Confirmed Acute Rejection||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||subjects|||Number
2843719|NCT00129961|Secondary|Graft Survival Measured by Graft Loss|Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||graft loss|||Number
2843720|NCT00129961|Secondary|Number of Participants That Died||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
2843721|NCT00129961|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. All available data, no imputations.|||μmol/L||Standard Deviation|Mean
2843722|NCT00129961|Secondary|Nankivell-Calculated Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|At 24 months (week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. For the intention to treat analysis, a GFR of 0 was imputed for graft loss or death, and last observation carried forward (LOCF) for missing values.|||units on scale||Standard Deviation|Mean
2843723|NCT00129961|Secondary|Number of Subjects Who Discontinue Assigned Therapy||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
2843724|NCT00129961|Secondary|Death Due to NMSC||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
2843725|NCT00129961|Secondary|Subjects Reporting Incidence of Metastatic Disease Related to NMSC.|The number of subjects with metastatic disease related to NMSC.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
2843760|NCT00129727|Secondary|Toxicity|Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study|60 months||||Participants|||Number
2843726|NCT00129961|Secondary|Number of Recurrent NMSC Lesions Per Subject-year|Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||lesions per participant year|||Number
2843727|NCT00129961|Secondary|Grade Distribution of NMSC Lesions|Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
2843728|NCT00129961|Secondary|Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||Percentage of Participants|||Number
2843729|NCT00129961|Secondary|Number of Lesion Free Subjects|The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||participants|||Number
2843730|NCT00129961|Secondary|Time to First Biopsy Confirmed New NMSC Lesion.|The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||number of days||95% Confidence Interval|Median
2843731|NCT00129961|Primary|New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year|The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.|||Standardized Yearly Rate of NMSC|||Number
2843732|NCT00129935|Secondary|Quality of Life Questionnaire: Time to Taking Off the Wig|"Time to taking off the wig was assessed by a specific Hair Toxicity Questionnaire were patients answered when they stop to use the wig.~The questionnaire was evaluated up to two years after the end of chemotherapy."|Up to 30 months|There is only information about take off the wig in 241 patients: Arm A: 111 and Arm B 130|||Months||95% Confidence Interval|Median
2843733|NCT00129935|Secondary|Quality of Life Questionnaire: Number of Participants With Hair Loss Recovery|"Hair Loss Recovery was assessed by a specific Hair Toxicity Questionnaire were patients answered if the hair was less abundant than before, weaker than before or other.~The questionnaire was evaluated up to two years after the end of chemotherapy."|Up to 30 months|360 patients completed a questionnaire specifically on hair loss 1-2 years after the end of chemotherapy. Arm A: 174 and Arm B 184 patients suffer hair loss|||Participants|||Count of Participants
2843734|NCT00129935|Secondary|Quality of Life Questionnaire: Number of Participants With Hair Loss|"Hair loss was assessed by the quality of life of the patients through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 23 (EORTC QLQ-BR23) profile questionnaire, question 4. The quality of life of the patients was evaluated before each cycle and at the end of treatment.~In questionnaire, raw scores range from 0 to 100 and a high score represents a high level of functioning or Health Related Quality of Life, excluding single-item scales in which high scores represent a high level of symptoms. A difference of 10 points on the scale over baseline value was classified as the minimum clinically meaningful change in both questionnaires."|Up to 24 months|360 patients completed a questionnaire specifically on hair loss 1-2 years after the end of chemotherapy|||Participants|||Count of Participants
2843735|NCT00129935|Secondary|The Number of Participants Who Experienced Adverse Events (AE)|Safety was assessed by standard clinical and laboratory tests, and were evaluated using NCI-CTC criteria v2.0|5 years||||Participants|||Count of Participants
2843736|NCT00129935|Secondary|Number of Participants With Overall Survival (OS) Event|A participant was considered to have had a OS event if patient died from any cause.|Up to 5 years||||Participants|||Count of Participants
2843737|NCT00129935|Primary|Number of Participants With Disease-free Survival (DFS) Event|A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.|5 years||||Participants|||Count of Participants
2843738|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4|Mean serum concentrations of motavizumab at 30 days post Dose 4|30 days post Dose 4|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements|||ug/mL||Standard Deviation|Mean
2843739|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3|Mean serum concentrations of motavizumab at 30 days post Dose 3|30 days post Dose 3|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements|||ug/mL||Standard Deviation|Mean
2843740|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2|Mean serum concentrations of motavizumab at 30 days post Dose 2|30 days post Dose 2|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements|||ug/mL||Standard Deviation|Mean
2843741|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1|Mean serum concentrations of motavizumab at 30 days post Dose 1|30 days post Dose 1|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements|||ug/mL||Standard Deviation|Mean
2843742|NCT00129766|Secondary|The Serum Concentrations of Motavizumab at Day 0|Mean serum concentrations of motavizumab at Day 0|Day 0|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.|||ug/mL||Standard Deviation|Mean
2843743|NCT00129766|Secondary|The Number of Participants With Anti-motavizumab Antibodies|Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.|Day 0 - 120|N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217|||participants|||Number
2843744|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended OM Infections|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||number of prescriptions||Standard Deviation|Mean
2843745|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended LRI|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Number of prescriptions||Standard Deviation|Mean
2843746|NCT00129766|Secondary|The Incidence of Medically-attended Otitis Media (OM) Infections|Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Participants|||Number
2843747|NCT00129766|Secondary|The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups|The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.|Days 0 - 150|Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.|||Participants|||Number
2843748|NCT00129766|Secondary|The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)|LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.|Day 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Participant|||Number
2843749|NCT00129766|Primary|Number of Participants Reporting Changes in Vital Signs From Baseline|Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843750|NCT00129766|Primary|Number of Participants Who Died||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843751|NCT00129766|Primary|Number of Participants Who Discontinued Study Drug Due to AEs||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843752|NCT00129766|Primary|Number of Participants Reporting AEs by Highest Severity Grade|Adverse events events were graded by severity; Level 1, 2, 3, or 4|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843753|NCT00129766|Primary|Number of Participants Reporting Any Related SAEs|Number of participants reporting one or more SAEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843754|NCT00129766|Primary|Number of Participants Reporting Any Serious Adverse Events (SAEs)|Number of participants reporting one or more SAEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843755|NCT00129766|Primary|Number of Participants Reporting Any Related AEs|Number of participants reporting one or more AEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843756|NCT00129766|Primary|Number of Participants Reporting Any Adverse Events (AEs)|Number of participants reporting one or more AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.|||participants|||Number
2843757|NCT00129766|Primary|Incidence of RSV Hospitalization (Includes Deaths by RSV)|RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.|||Participants|||Number
2843758|NCT00129740|Secondary|Number of Participants With Complete Cytogenetic Response (CCyR)|"Complete hematologic remission classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or i Fluorescence in situ hybridization (FISH)~No cytogenetic response - Ph positive 100%~Minor cytogenetic response - Ph positive 35-90%~Partial cytogenetic response - Ph positive 1-34%~Complete cytogenetic response - Ph positive 0% Major cytogenetic response = complete + partial (Ph positive <35%)"|6 months||||Participants|||Count of Participants
2843759|NCT00129740|Primary|Participants With Complete Molecular Response (Molecular CR)|Polymerase chain reaction (PCR) Ratio BCR-Abl/Abl of 0% after 12 months of therapy with Nilotinib by international standard.|12 months||||Participants|||Count of Participants
2843762|NCT00129727|Primary|PFS|Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer|Median PFS in months - up to 5 years||||Months||95% Confidence Interval|Median
2843763|NCT00129701|Primary|Costs Associated With Traditional Face to Face Consultation|Patient costs attending hospital appointments compare to phone consultations|1 year|No data collected||||||
2843764|NCT00129701|Primary|Patients Needing Expedited Follow up|Number of participants who were telephoned and needed expedited follow-up|After phone consultation within 2 weeks|Number of participants who were telephoned at the pre-arranged time and they were available|||Participants|||Count of Participants
2843765|NCT00129701|Primary|Patient Satisfaction|"MISS-21 satisfaction scale, The 21 items are scored using a 7-point Likert scale with responses ranging from 1 (Very strongly disagree) to 7 (Very strongly agree). Maximum is 147 Very strong satisfaction - best outcome, minimum 21 very strong dissatisfaction."|After consultation within 1 months|Participants who attended both types of consultations|||score on scale||Standard Deviation|Mean
2843766|NCT00129649|Primary|Attendance Rates at Respiratory Outpatient Clinics|rates of attendance measured for scheduled clinics - attended patients|after phone call within 1 week|Lower participants number in the telephone reminder group, only participants who were could be contacted before the appointment|||Participants|||Count of Participants
2843767|NCT00129623|Secondary|Number of Participants With Marked Laboratory Abnormalities|Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].|Screening up to 12 months|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.|||participants|||Number
2843768|NCT00129623|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 15 days after end of study treatment (Approximately 2 years)|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.|||participants|||Number
2843769|NCT00129623|Secondary|Percentage of Responders|Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.|Up to 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||Percentage|||Number
2843770|NCT00129623|Secondary|Absolute Change From Baseline in sCTX|Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6, 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.|||ng/ml||95% Confidence Interval|Median
2843771|NCT00129623|Secondary|Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)|Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6 and 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.|||Percentage||95% Confidence Interval|Median
2843772|NCT00129623|Secondary|Absolute Change From Baseline in BMD of the Proximal Femur at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||g/cm^2||Standard Deviation|Mean
2843773|NCT00129623|Secondary|Relative Change From Baseline in Mean Proximal Femur BMD at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||Percentage||Standard Deviation|Mean
2843788|NCT00129441|Primary|Preparing to Overcome Prepotency Task - Error Rate|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4||||proportion of errors||Standard Deviation|Mean
2843774|NCT00129623|Secondary|Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||g/cm^2||Standard Deviation|Mean
2843775|NCT00129623|Primary|Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.|||Percentage||Standard Error|Least Squares Mean
2843776|NCT00129545|Secondary|Procedure Success|Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.|Initial implant procedure|14 subjects did not have an implant procedure attempted|||percentage of implant attempts|||Number
2843777|NCT00129545|Primary|The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events|Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.|5 years|"Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics~Roll-in subjects were not included in the primary outcome analysis per study design."|||Events per 100 pt-yrs||95% Confidence Interval|Number
2843778|NCT00129545|Primary|Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death|A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)|5 years|"event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics~Roll-in subjects were not included in the primary outcome analysis per study design."|||events per 100 pt yrs||95% Confidence Interval|Number
2843779|NCT00129480|Secondary|Adjusted Change in Health Related Quality of Life|EQ-5D. Range 3-15 with higher scores representing worse health states|12 months||||units on a scale||95% Confidence Interval|Mean
2843780|NCT00129480|Secondary|Global Impression of Change|Global impression of change score. Rated at 12 months capturing patient impression of change over past 6 months. Range 1-7 with lower scores representing greater improvement|12 months||||units on a scale||95% Confidence Interval|Mean
2843781|NCT00129480|Secondary|Adjusted Change in Pain Interference|Chronic Pain Grade interference score. Range 0 to 100 with higher scores representing greater pain interference (worse outcome)|12 month||||units on a scale||95% Confidence Interval|Mean
2843782|NCT00129480|Secondary|Adjusted Change in Depression Severity|Patient Health Questionnaire-9 depression rating scale. Range 0-27 with higher scores representing higher depression severity|12 months||||units on a scale||95% Confidence Interval|Mean
2843783|NCT00129480|Primary|Adjusted Change in Pain-related Function (Roland Disability Score)|The Roland Morris Disability Questionnaire has 24 yes or no items. Each item is scored as 0 or 1. Item scores or summed to create total score with range 0 to 24. Higher scores represent greater disability. The Roland Morris has been widely used, has content and construct validity, internal consistency, and responsiveness to change among patients with chronic pain.|12 months||||units on a scale||95% Confidence Interval|Mean
2843784|NCT00129467|Primary|Days to Remission of Depression|Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.|18 Days|The number of participants analyzed is the number of who received the intervention|||Days||Standard Error|Mean
2843785|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex|"The Delayed Memory Index consists of verbal and nonverbal recall tasks (words, drawings) that the subject views early in the evaluation and without warning, is asked to recall ~1/2 hr later. Scores are expressed as standardized scores normalized to a population mean of 100, with a standard deviation of 15 (possible scores between 40-135). Higher scores reflect better performance. Subjects received the A form at baseline and wk-4 visit and the B form at the wk-2 visit (A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.|||Standard Score||Standard Deviation|Mean
2843786|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score|"Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. All subjects received the A form at baseline and the wk-4 visit and the B form at the wk-2 visit (the A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.|||Standard Score||Standard Deviation|Mean
2843787|NCT00129441|Secondary|Brief Psychiatric Rating Scale Total Score|The Brief Psychiatric Rating Scale-anchored (BPRS; Overall and Gorham, 1962; Woerner, Mannuzza, Kane, 1988) is an 18-item scale that is among the most widely used measure of psychopathology. Scores range from 1-7, with higher scores reflecting greater pathology. A total score is derived from the sum of all 18 items (possible scores range from 18-126). It relies on clinical judgment in the assessment of key areas of psychopathology (depression, anxiety, psychosis).|Week 4|One subject dropped out prior to completing study|||Scores on a scale||Standard Deviation|Mean
2843789|NCT00129441|Primary|Preparing to Overcome Prepotency (POP) Task - Reaction Time|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4||||msec||Standard Deviation|Mean
2843790|NCT00129441|Primary|AX Continuous Performance Test Task D-prime|For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.|Week 4|Four subjects did not complete a sufficient number of trials for the AXCPT task at both testing periods, therefore 7 L-830982 and 4 placebo subjects data were analyzed.|||d-prime||Standard Deviation|Mean
2843791|NCT00129441|Primary|N-back Task - Error Rate|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.|||proportion of errors||Standard Deviation|Mean
2843792|NCT00129441|Primary|N-back Task - Reaction Time|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.|||msec||Standard Deviation|Mean
2843793|NCT00129402|Secondary|Percent Change From Baseline in HDL-C||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
2843794|NCT00129402|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
2843795|NCT00129402|Secondary|Percent Change From Baseline in Triglycerides (TG)||baseline to 6 weeks|ITT|||percent change||Standard Deviation|Median
2843796|NCT00129402|Secondary|Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
2843797|NCT00129402|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||baseline to 6 weeks|ITT|||percent change||Standard Error|Least Squares Mean
2843798|NCT00129402|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy|baseline to 6 weeks|The analysis was performed on the intent to treat (ITT) population. Although 248 subjects received randomized treatment, two of the subjects did not have at least one baseline and at least one postbaseline lipid determination and thus could not be analyzed in the ITT population. Therefore, the actual ITT population consisted of 246 subjects.|||percent change||Standard Error|Least Squares Mean
2843799|NCT00129389|Secondary|Overall Survival (OS) Event|OS event is defined as the death from any cause.|Up to 5 years||||Participants|||Count of Participants
2843800|NCT00129389|Primary|Disease-free Survival (DFS) Event|DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.|Up to 5 years||||Participants|||Count of Participants
2843801|NCT00129376|Secondary|Number of Participants With Over-expression of p27 (>75% Cells With Nuclear Staining)|Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Sections were rated according to the percentage of tumor cells nuclei with positive staining (1 = < 25%; 2 = between 25-75% and 3 = > 75%).|Up to 29 weeks|20 patient tumor sample could not be evaluated|||Participants|||Count of Participants
2843802|NCT00129376|Secondary|Number of Participants With Over-expression of Survivin (>1% Cells With Nuclear Staining)|Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Tumors with more than 1% of cells with nuclear staining were considered to be over-expressing this protein.|Up to 29 weeks|17 patient tumor sample could not be evaluated|||Participants|||Count of Participants
2843803|NCT00129376|Secondary|Number of Participants With Over-expression of Topo II (>10% Cells With Nuclear Staining)|Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Over-expression of Topo II was defined as >10% cells with nuclear staining.|Up to 29 weeks|20 patient tumor sample could not be evaluated|||Participants|||Count of Participants
2843804|NCT00129376|Secondary|Clinical Response Rate (CRR)|"CRR measured according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, where:~Complete Response (CR): disappearance of all target lesions~Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions~Progresive Disease (PD): >=20% increase from smallest sum of longest diameter recorded since treatment started (best response).~Stable Disease (SD): Neither PD nor PR"|Up to 29 weeks||||Participants|||Count of Participants
2843805|NCT00129376|Primary|Pathological Complete Response (pCR) Rate|Pathological complete response was defined by the Miller & Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.|Up to 29 weeks|2 patients did not received surgery, 1 because of disease progression, and 1 due to inacceptable toxicity.|||Participants|||Count of Participants
2843806|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||Week 8||||participants|||Number
2843807|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||6-month follow up||||participants|||Number
2843808|NCT00129285|Secondary|Cocaine Selective Severity Assessment (CSSA) Total Score|Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment.|8 weeks|patients exposed to low dose and high dose modafinil|||units on a scale||Standard Deviation|Mean
2843809|NCT00129285|Secondary|Retention; Number of Evaluation Visits Attended|Number of visits attended compared between the three conditions using anova|8 weeks||||number of evaluation sessions attended||Standard Deviation|Mean
2843810|NCT00129285|Primary|Urine Toxicology for Cocaine|Abstinent in the final 3 weeks of treatment|3 weeks||||Participants|||Count of Participants
2843811|NCT00129272|Secondary|Withdrawal Symptoms|Hughes-Hatsukami Withdrawal Scale|Nine weeks|Analyzed all participants with last observation carried forward (LOCF).|||units on a scale;range0-36;higher worse||Standard Deviation|Mean
2843812|NCT00129272|Primary|Smoking Behavior|Number of cigarettes smoked daily in the previous week|Nine weeks|Analyzed all randomized participants with last observation carried forward (LOCF).|||cigarettes/day in the previous week||Standard Deviation|Mean
2843813|NCT00129259|Secondary|Change in Average Total Insulin Dose Per Body Weight|This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data|||Units of Insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
2843814|NCT00129259|Secondary|Change in HbA1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data|||Percentage (%)||Standard Deviation|Mean
2843815|NCT00129259|Primary|Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)|C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario.|Baseline (Pre-treatment), Month 24|Intent-to-treat|||pmol/mL||95% Confidence Interval|Least Squares Mean
2843816|NCT00129246|Primary|Weight Gain|Weight gain for for the entire sample in pounds at 6 weeks.|Week 6|Per protocol analysis|||lbs||Standard Deviation|Mean
2843817|NCT00129246|Secondary|Weight Gain Abstinent Participants|Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.|Week 6|Per protocol analysis|||lbs||Standard Deviation|Mean
2843818|NCT00129246|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.|Week 6|Per protocol analysis|||participants|||Number
2843819|NCT00129246|Primary|Smoking Cessation|Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.|Week 6|Per protocol analysis|||participants|||Number
2843820|NCT00129220|Secondary|Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score|Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).|Baseline to 6 weeks|Participants in the Safety Analysis Set (participants who had baseline and post-baseline measurements). Participants were included in the treatment group for which they actually received treatment.|||units on a scale||Standard Deviation|Mean
2843821|NCT00129220|Secondary|Percentage of Participants Who Switched to Syndromic Depression|Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline.|||percentage of participants|||Number
2843822|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2843823|NCT00129220|Secondary|Percentage of Participants Who Switched to Symptomatic Depression|Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline.|||percentage of participants|||Number
2844008|NCT00128492|Primary|Serum Hematology - Number of Red Blood Cells (RBC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||number x10^6/µL||Standard Deviation|Mean
2843824|NCT00129220|Secondary|Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||percentage of participants|||Number
2843825|NCT00129220|Secondary|Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||percentage of participants|||Number
2843826|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2843827|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2843828|NCT00129220|Secondary|Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)|Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||percentage of participants|||Number
2843829|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2843830|NCT00129220|Primary|Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 3 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2843831|NCT00129129|Secondary|Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)|Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843832|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843833|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843834|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843835|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2844490|NCT00124618|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From baseline to up to 3 years||||months||95% Confidence Interval|Median
2843836|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843837|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|"Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. Any= any report of the specified symptom irrespective of intensity and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; Grade 3 for Drowsiness, Irritability/Fussiness = prevented normal activity; Grade 3 Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); Grade 2 or 3 for fever = T >39.0°C; Grade 3 for fever = T >40.0°C"|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843838|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|"Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. Any= any report of the specified symptom irrespective of intensity and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; Grade 3 for Drowsiness, Irritability/Fussiness = prevented normal activity; Grade 3 Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); Grade 2 or 3 for fever = T >39.0°C; Grade 3 for fever = T >40.0°C"|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843839|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|"Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. Any= any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling >10 millimeters (mm); Grade 3 redness/swelling = redness/swelling >30 mm; Grade 2 limb circumference (LC) = LC >20 mm; Grade 3 LC = LC >40 mm"|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.|||Participants|||Count of Participants
2843840|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|"Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. Any= any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling >10 millimeters (mm); Grade 3 redness/swelling = redness/swelling >30 mm; Grade 2 limb circumference (LC) = LC >20 mm; Grade 3 LC = LC >40 mm"|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase|||Participants|||Count of Participants
2843841|NCT00129129|Secondary|Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2843842|NCT00129129|Secondary|Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)||Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843843|NCT00129129|Secondary|Anti-PSY Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2843844|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843845|NCT00129129|Secondary|Anti-PSC Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2844518|NCT00124072|Secondary|Major Coronary Events|Non-fatal MI, coronary death or coronary revascularisation|6.7 years median follow-up|||||||
2843846|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843847|NCT00129129|Secondary|hSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2843848|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843849|NCT00129129|Secondary|hSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2843850|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843851|NCT00129129|Secondary|rSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2843852|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843853|NCT00129129|Secondary|rSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2843854|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843855|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2843856|NCT00129129|Secondary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2844519|NCT00124072|Secondary|MVEs in Presence and Absence of the Other Factorial Treatment||6.7 years median follow-up|||||||
2843857|NCT00129129|Secondary|Concentration of Antibodies Against Streptococcus Pneumonia Serotypes|"Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2843858|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843859|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843860|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843861|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):~Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),~At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,~At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843862|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):~Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),~Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843863|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):~Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),~At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,~At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843873|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|"Solicited local symptoms were pain, redness and swelling at injection site. Any = any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); Grade 3 redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups ."|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2844520|NCT00124072|Secondary|MVEs in Patients Subdivided Into 3 Groups by Baseline Low-density Lipoprotein (LDL)||6.7 years median follow-up|||||||
2843864|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):~Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),~Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.|||Participants|||Count of Participants
2843865|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843866|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843867|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843868|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843869|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843870|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843871|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|"Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Any = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; Grade 3 for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); Grade 2 or 3 fever = rectal temperature higher than (>) 39°C; Grade 3 fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups"|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843872|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|"Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Any = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; Grade 3 for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); Grade 2 or 3 fever = rectal temperature higher than (>) 39°C; Grade 3 fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups ."|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2844521|NCT00124072|Secondary|MVEs Separately in Year 1 and in Later Years||6.7 years median follow-up|||||||
2843874|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|"Solicited local symptoms were pain, redness and swelling at injection site. Any = any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); Grade 3 redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups ."|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843875|NCT00129129|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843876|NCT00129129|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
2843877|NCT00129129|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843878|NCT00129129|Secondary|Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to the primary vaccination course (at Day 0)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2843879|NCT00129129|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843880|NCT00129129|Secondary|Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||mIU/mL||95% Confidence Interval|Geometric Mean
2843881|NCT00129129|Secondary|Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843882|NCT00129129|Secondary|Anti-diphtheria and Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||IU/mL||95% Confidence Interval|Geometric Mean
2843914|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
2844009|NCT00128492|Primary|Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||percent of differential||Standard Deviation|Mean
2843883|NCT00129129|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)|The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843884|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843885|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843886|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843887|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
2843888|NCT00129129|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values|Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843889|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843890|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843891|NCT00129129|Secondary|Number of Subjects Reporting Medically Attended Visits|A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843892|NCT00129129|Secondary|Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
2843893|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values|Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843894|NCT00129129|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
2843895|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values|Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843896|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843897|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843898|NCT00129129|Secondary|Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
2843899|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values|rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843900|NCT00129129|Secondary|Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
2843901|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values|rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||Participants|||Count of Participants
2843902|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .|One month after the fourth dose (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.|||Participants|||Count of Participants
2843903|NCT00129129|Primary|Number of Subjects Reporting Any Grade 3 Symptoms|"Symptoms were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A Grade 3 symptom was defined as any symptom that prevented normal everyday activity. Any was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups ."|During the 4-day follow-up period after each primary vaccine dose|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.|||Participants|||Count of Participants
2843904|NCT00129129|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2843905|NCT00129129|Primary|Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.|||µg/mL||95% Confidence Interval|Geometric Mean
2843906|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase|||Participants|||Count of Participants
2843907|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the booster phase (up to study Month 1 - booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
2843908|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
2843909|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
2843910|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.|||Subjects|||Number
2843911|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the primary phase (up to study Month 3 - primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
2843912|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
2843913|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.|||Subjects|||Number
2843915|NCT00129116|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843916|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843917|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-hepatitis B Antibodies|Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843918|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-diphtheria Antibodies|Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843919|NCT00129116|Secondary|Anti-poliovirus Types 1, 2, 3 Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Titers||95% Confidence Interval|Geometric Mean
2843920|NCT00129116|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
2843921|NCT00129116|Secondary|Anti-diphtheria Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2843922|NCT00129116|Secondary|Anti-T Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2843923|NCT00129116|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).|Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843924|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2843925|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2843926|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843927|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843928|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Titres||95% Confidence Interval|Geometric Mean
2843929|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2843930|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128|rSBA-MenY antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843931|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128|rSBA-MenC antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843932|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2843933|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843934|NCT00129116|Secondary|Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)|Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843935|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-tetanus Antibodies|Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843936|NCT00129116|Secondary|Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||EL.U/mL||95% Confidence Interval|Least Squares Mean
2843937|NCT00129116|Secondary|Anti-tetanus Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2843938|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
2843939|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
2843940|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843941|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2846924|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population||Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2843942|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
2843943|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843944|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Titers||95% Confidence Interval|Geometric Mean
2843945|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Titers||95% Confidence Interval|Geometric Mean
2843946|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843947|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843948|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Prior to the booster vaccination (at study Month 0 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843949|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843950|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843951|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843952|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843953|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2843954|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after the booster vaccination (at study Month 1 - booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.|||Subjects|||Number
2844004|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin (MCH)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||pg||Standard Deviation|Mean
2843955|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843956|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843957|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.|||Subjects|||Number
2843958|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.|Phosphate: any Phosphate increase would refer to a positive response.|6 months||||participants|||Number
2843959|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium|Magnesium: Any Magnesium increase would refer to a positive response.|6 months||||participants|||Number
2843960|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase|Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response|6 months||||participants|||Number
2843961|NCT00128921|Secondary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin|Osteocalcin: Any Osteocalcin increase means positive response.|6 months||||participants|||Number
2843962|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium|Calcium: any Calcium increase would refer to a positive response.|6 months||||participants|||Number
2843963|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone|Parathyroid hormone: Any increase in PTH was considered response|6 months||||participants|||Number
2843964|NCT00128830|Primary|Number of Participants With Adverse Events|Number of participants who reported at least 1 of the adverse events.|Up to 3 years|Intent-to-treat population: Participants who received at least 1 dose of study medication were included|||Participants|||Number
2843965|NCT00128830|Secondary|Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)|Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant).|Baseline and Endpoint (ie, the last available time point during the treatment period)|Intent-to-treat population: Participants who received at least 1 dose of study medication were included|||Participants|||Number
2843966|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192|||x 1000000 cells/mL||Full Range|Median
2843967|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||x 1000000 cells/mL||Full Range|Median
2843968|NCT00128830|Secondary|Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||x 1000000 cells/L||Full Range|Median
2843969|NCT00128830|Secondary|Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48|||x 100000 cells/L||Full Range|Median
2843970|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192|||Participants|||Number
2843971|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||Participants|||Number
2844005|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Volume (MCV)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||fL||Standard Deviation|Mean
2843972|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96|||Participants|||Number
2843973|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48|||Participants|||Number
2843974|NCT00128713|Secondary|Highest Grade of Bleeding While on Study|Highest grade of bleeding during time on study using Platelet Dose Trial modification of World Health Organization Bleeding Scale. Grades 0-1 (no or minimal bleeding), 2 (moderate bleeding), 3 (bleeding generally requiring red cell transfusion), 4 (severe bleeding)|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|The analysis was done as intention to treat. Subjects for which highest grade of bleeding could not be determined (non-evaluable) were excluded.|||participants|||Number
2843975|NCT00128713|Secondary|Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends|No suitable scale was identified, so no analyses for this outcome were carried out|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Analysis not performed; no applicable bleeding severity scale validated and published by end of PLADO Study||||||
2843976|NCT00128713|Secondary|Number of Platelet Transfusion Episodes|Number of platelet transfusion episodes among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.|||Number of platelet transfusion episodes||Full Range|Median
2843977|NCT00128713|Secondary|Platelet Utilization|Total number of platelets transfused, based on attempted dose, among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.|||Number of platelets (x10^11)||Full Range|Median
2843978|NCT00128713|Primary|At Least One Day With Grade 2 or Higher Bleeding|Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|These analyses were done on an intention-to-treat basis. That is, patients were counted in the treatment arm to which they were randomly assigned, even if they actually received transfusions that were not according to their assigned dosing strategy.|||participants|||Number
2843979|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 30 days (Days 0-29) after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843980|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From the fourth year follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843981|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the third year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843982|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the second year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2844006|NCT00128492|Primary|Serum Hematology - Hemoglobin||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||g/dL||Standard Deviation|Mean
2844007|NCT00128492|Primary|Serum Hematology - Hematocrit||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||percent||Standard Deviation|Mean
2843983|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the first year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843984|NCT00128661|Secondary|Number of Subjects With All Possible Pregnancy Outcomes|The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.|During the entire study period (From Month 0 up to Month 48).|The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects.|||subjects|||Number
2843985|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843986|NCT00128661|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843987|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843988|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843989|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843990|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2843991|NCT00128661|Secondary|HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)|Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
2843992|NCT00128661|Secondary|HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)|Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
2843993|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort|Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
2843994|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.|Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination. Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.|||Titers||95% Confidence Interval|Geometric Mean
2843995|NCT00128661|Secondary|Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases|Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type. Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months. Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type.|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843996|NCT00128661|Secondary|Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen. Note: The assay did not distinguish between HPV types 68 and 73. CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843997|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843998|NCT00128661|Primary|Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.|CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).|||Events|||Number
2843999|NCT00128492|Primary|Serum Chemistry - Concentration of Total Protein||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||g/dL||Standard Deviation|Mean
2844000|NCT00128492|Primary|Serum Chemistry - Concentration of Chloride, Potassium, and Sodium||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||mEq/L||Standard Deviation|Mean
2844001|NCT00128492|Primary|Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||mg/dL||Standard Deviation|Mean
2844002|NCT00128492|Primary|Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||U/L||Standard Deviation|Mean
2844003|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||g/dL||Standard Deviation|Mean
2844010|NCT00128492|Primary|Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets||Baseline and end of Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI. Results obtained at the end of a 28-day treatment period are presented for selected timepoints.|||number of cells x10^3/µL||Standard Deviation|Mean
2844011|NCT00128492|Primary|Change in Respiratory Rate (RR)|"RR was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||breaths/minute||Standard Deviation|Mean
2844012|NCT00128492|Primary|Change in Temperature|"Temperature was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||degrees Celsius||Standard Deviation|Mean
2844013|NCT00128492|Secondary|Time to Intravenous (IV) Antipseudomonal Antibiotics|Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Days||95% Confidence Interval|Median
2844014|NCT00128492|Secondary|Missed School/Work Days Due to CF Symptoms|"Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.~The percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Percentage of days missed||Standard Deviation|Mean
2844015|NCT00128492|Secondary|Change in Body Weight|Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Percent change from baseline||Standard Error|Mean
2844016|NCT00128492|Secondary|Time to First Hospitalization Due to a Respiratory Event|"Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).~Time to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Days||Full Range|Median
2844017|NCT00128492|Secondary|Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Units on a scale||Standard Deviation|Mean
2844018|NCT00128492|Secondary|Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)|"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.~FEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.~The percent change from baseline is presented for each endpoint."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Percent change from baseline||Standard Deviation|Mean
2844019|NCT00128492|Secondary|Minimum Inhibitory Concentration (MIC) of Aztreonam|"The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||µg/mL|||Number
2844020|NCT00128492|Secondary|Number of Participants With Other Pathogens|"Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive [MSSA] and methicillin-resistant [MRSA] S.aureus), and fungal organisms.~Number of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Participants|||Number
2844091|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844021|NCT00128492|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum|"Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).~Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero."|Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Log10 PA CFUs/g||Standard Deviation|Mean
2844022|NCT00128492|Primary|Change in Systolic and Diastolic Blood Pressure (BP)|"BP was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||mm Hg||Standard Deviation|Mean
2844023|NCT00128492|Primary|Change in Heart Rate (HR)|"HR was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||beats/minute||Standard Deviation|Mean
2844024|NCT00128492|Primary|Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI|Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||Participants|||Number
2844025|NCT00128492|Primary|Number of Participants Reporting Adverse Events (AEs)|"Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.~Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.|||participants|||Number
2844026|NCT00128401|Secondary|Liebowitz Social Anxiety Scale (LSAS)|"Social anxiety symptoms were assessed using the Liebowitz Social Anxiety Scale (LSAS). It is a 24-item self-report instrument that measures overall social anxiety fear and avoidance symptoms. This is the baseline assessment. The 24 items are each rated twice, from a 0 to 3 scale, with 0 indicated no level of symptom and 3 indicating a high level of the system. One rating is for anxiety, and the other is for avoidance. Thus, the lowest possible score is 0, and the highest possible score is 144. The total score represents the simple sum of all 48 ratings."|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo|||units on a scale||Standard Deviation|Mean
2844027|NCT00128401|Primary|Clinical Global Improvement (CGI-S) Scale|Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures the patients' illness severity and global improvement. The minimum value for the CGI is 1=Normal, not at all ill and the maximum value is 7=Among the most extremely ill patients.|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo|||units on a scale||Standard Deviation|Mean
2844028|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 18|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 18. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844029|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 16|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 16. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844030|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 14|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 14. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844092|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844031|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 12|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 12. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844032|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 10|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 10. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844033|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 8|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 8. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844034|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 6|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 6. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844035|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 4|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 4. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844036|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 2|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 2. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844037|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 1|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 1. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844038|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 0|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 0 prior to vaccination.|Month 0|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Swabs|||Number
2844039|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits|Number of vaginal GBS III culture positive for 3+ consecutive visits was calculated from the post-vaccination visits over the 18 month follow-up. Status at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
2844040|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive.|Number of participants whose vaginal swabs were type III GBS culture positive was calculated using data from the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up/final visit was imputed from the previous visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
2844041|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study.|Number of participants who were vaginal type III GBS negative was calculated throughout the the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up /final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
2844042|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 18 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844043|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 16 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844044|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 14 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844045|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 12 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844046|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 10 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844047|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 8 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844048|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 6 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844049|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 4 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844050|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 2 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844051|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 1 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844052|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0|Blood samples were collected from participants at each scheduled clinic visit beginning with Month 0 prior to vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 0 prior to vaccination|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844053|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 18 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 18 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844054|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 16 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 16 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844055|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 14 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 14 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844056|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 12 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 12 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844057|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 10 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 10 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844058|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 8 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 8 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844059|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 6 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 6 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844060|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 4 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 4 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844061|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 2 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 2 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844062|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 1 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 1 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||participants|||Number
2844063|NCT00128219|Secondary|Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination|Fold-rises compare the IgG antibody level at post-vaccination to that obtained just prior to vaccination, for each visit during the 18-month follow-up period. Assay results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Ratio||95% Confidence Interval|Mean
2844064|NCT00128219|Secondary|Number of Participants With Any Solicited Local and Systemic Symptoms.|Participants maintained a diary card to report the occurrence of solicited local and systemic symptoms for 7 days after vaccination. Participants are counted if they indicated experiencing the symptom at any severity during the reporting period.|Safety surveillance during the 1st 7 days.|The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).|||Participants|||Number
2844065|NCT00128219|Secondary|Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination.|The GMC was calculated from IgG antibody to type III GBS assay results on serum specimens obtained at clinic visits during the 18 month post-vaccination follow-up period. Results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||µg/ml||95% Confidence Interval|Geometric Mean
2844066|NCT00128219|Primary|The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture.|Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.|Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the intention to treat (ITT) Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.|||Participants|||Number
2844067|NCT00128206|Secondary|Cost Effectiveness||course of treatment|||||||
2844068|NCT00128206|Secondary|Completion of Therapy||course of treatment|||||||
2844069|NCT00128206|Primary|Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication|Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.|up to one year|The number of participants was determined by power calculations using estimates of toxicity from the literature. The analysis was intention to treat.|||participants|||Number
2844093|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844070|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen PPD|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1 and C1b who received the antigen are included in the analysis population.|||Participants|||Number
2844071|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
2844072|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
2844073|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
2844074|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
2844075|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Groups C1 and C1b who received the antigen are included in the analysis population.|||Participants|||Number
2844076|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
2844077|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
2844078|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.|||Participants|||Number
2844079|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.|||Participants|||Number
2844080|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 28|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844081|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1, B2, C1 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844082|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844083|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Groups A1 and A2 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844084|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844085|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844086|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A2 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844087|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844088|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1b who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844089|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844090|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A1, B1 and C1 who had measurable induration at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844094|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844095|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844096|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844097|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844098|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844099|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844100|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844101|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844102|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844103|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.|||Millimeters||Standard Deviation|Mean
2844104|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
2844105|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
2844106|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
2844123|NCT00128180|Primary|The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation||28 days|Per protocol, the efficacy analysis was limited to participants with confirmed hantavirus infection.|||proportion of paticipants|||Number
2844107|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
2844108|NCT00128193|Primary|Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days||||Participants|||Number
2844109|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
2844110|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
2844111|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
2844112|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.|||Participants|||Number
2844113|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable erythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.|||Participants|||Number
2844114|NCT00128180|Secondary|Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry||6 months|Per protocol, this efficay analysis was limited to participants with confirmed hantavirus infection who did not have a serum creatinine equal or greater to 3.0 mg/dL at entry.|||participants|||Number
2844115|NCT00128180|Secondary|Length of Time on a Ventilator||6 months|Per protocol this efficacy analysis was limited to participants with confirmed hantavirus infection who were intubated and on a ventillator.|||days||Standard Deviation|Mean
2844116|NCT00128180|Secondary|Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry|Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output.|6 months|Per protocol, this efficacy analysis was limited to participants with confirmed hantavirus infection who were not already in shock at study entry.|||participants|||Number
2844117|NCT00128180|Secondary|Number of Participants Intubated and Placed on a Ventilator After Study Entry.|Participants|6 months|This efficacy this analysis was limited to participants with confirmed hantavirus infection who were not already intubated at study entry.|||participants|||Number
2844118|NCT00128180|Secondary|Duration of Shock and/or Pressor/Inotropic Support|Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output.|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.|||days||Standard Deviation|Mean
2844119|NCT00128180|Secondary|Duration of Hospital Stay in Days|Days|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantairus infection.|||days||Standard Deviation|Mean
2844120|NCT00128180|Secondary|Duration of ICU Stays||6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection, and this analysis was limited to those who were admitted to ICU. Four subjects with confirmed hantavirus infection were not admitted to ICU.|||days||Standard Deviation|Mean
2844121|NCT00128180|Secondary|Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)|number of participants|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.|||participants|||Number
2844122|NCT00128180|Primary|Number of Participants With SAEs|The Number of participants with SAEs|6 months|Per protocol, safety analysis inluded all participants, including those where hantavirus infection was not confirmed.|||participants|||Number
2844124|NCT00127933|Secondary|Participants With Overall Survival|Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.|22 - 1191 days|The analysis was done on the post-operative Response Evaluable Population.|||participants|||Number
2844125|NCT00127933|Secondary|Participants With Disease-Free Survival|Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.|30 - 1102 days|The analysis was done on the Postoperative Response Evaluable Population.|||participants|||Number
2844126|NCT00127933|Secondary|Percentage of Participants With Local Recurrence|Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.|30 - 1102 days|Postoperative Response Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2844127|NCT00127933|Secondary|Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))|The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.|post 2 and 4, 3-week cycles of treatment|Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2844128|NCT00127933|Secondary|Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2844129|NCT00127933|Primary|Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population|||percentage of participants||95% Confidence Interval|Number
2844130|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month following administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the Booster Total Vaccinated Cohort.|||Subjects|||Number
2844131|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month after the 3-dose primary vaccination course (Month 5)|The analysis was performed on the Total Vaccinated Cohort.|||Subjects|||Number
2844132|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort.|||Subjects|||Number
2844133|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort.|||Subjects|||Number
2844134|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.|||Subjects|||Number
2844135|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.|||Subjects|||Number
2844198|NCT00127439|Primary|Foot Trajectory Range (Toe Off to Heel Strike)|Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).|12 weeks||||degrees||Standard Deviation|Mean
2844136|NCT00127855|Secondary|Anti-pneumococcal Antibody Concentrations|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2844137|NCT00127855|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844138|NCT00127855|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||Titer||95% Confidence Interval|Geometric Mean
2844139|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844140|NCT00127855|Secondary|Anti- HBs Antibody Concentrations|Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
2844141|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies|Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844142|NCT00127855|Secondary|Anti- PT Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
2844143|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies|Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844144|NCT00127855|Secondary|Anti-PRN Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
2844145|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies|Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844146|NCT00127855|Secondary|Anti- FHA Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.|||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
2844147|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies|Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844148|NCT00127855|Secondary|Anti-tetanus Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
2844149|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-tetanus Antibodies|Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844150|NCT00127855|Secondary|Anti-diphtheria Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||International Units per Milliliter||95% Confidence Interval|Geometric Mean
2844151|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-diphtheria Antibodies|Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.|||Subjects|||Number
2844152|NCT00127855|Secondary|Anti-PRP Antibody Concentration|Concentrations are presented as GMCs and expressed as µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2844153|NCT00127855|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
2844154|NCT00127855|Secondary|Anti-polysaccharide Y (PSY) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2844155|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
2844156|NCT00127855|Secondary|Anti-polysaccharide C (PSC) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2844193|NCT00127530|Primary|Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)|Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.|Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.|ITT Population|||Participants|||Number
2844194|NCT00127439|Primary|Kinematics: Trunk Angle Mid-Stance|Trunk Angle Mid-Stance - position in degrees|12 weeks||||degrees||Standard Deviation|Mean
2844157|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
2844158|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Titer||95% Confidence Interval|Geometric Mean
2844159|NCT00127855|Secondary|Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
2844160|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Titer||95% Confidence Interval|Geometric Mean
2844161|NCT00127855|Secondary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.|||Subjects|||Number
2844162|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.|||Subjects|||Number
2844163|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.|||Subjects|||Number
2844164|NCT00127855|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter|The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.|||Subjects|||Number
2844165|NCT00127842|Secondary|Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24|Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||percentage of participants||95% Confidence Interval|Number
2844190|NCT00127608|Primary|Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample by Storage Condition (Dry, Liquid)|The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by storage conditions (dry, liquid). As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs.|At Visit 1 (Day 0)|Only VZV DNA-positive samples were considered in this analysis.|||VZV genome copies per sample|samples|95% Confidence Interval|Log Mean
2844166|NCT00127842|Secondary|Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)|The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||percentage of participants||95% Confidence Interval|Number
2844167|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. Change was based on paired data.|||Percentage change||Full Range|Mean
2844168|NCT00127842|Secondary|Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||Units on a scale||Standard Deviation|Mean
2844169|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Physician Global Assessment|"The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites).~Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement."|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||Percentage change||Full Range|Mean
2844170|NCT00127842|Secondary|Change From Baseline to Month 24 in the Physician Global Assessment|The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||Units on a scale||Standard Deviation|Mean
2844171|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module|"In the HLQ impediments to paid and unpaid labor module participants were asked Were you hindered by health problems at your paid work over the past two weeks? and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points.|||Units on a scale||Standard Deviation|Mean
2844172|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and month 24|"Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). n indicates the number of participants who had unpaid or paid help with their unpaid work."|||Hours||Standard Deviation|Mean
2844191|NCT00127608|Primary|Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample|The estimated means of the viral load in log10 values for each storage condition (dry and liquid) and each type of sample are presented with 95% confidence intervals|At Visit 1 (Day 0)|One subject who was Varicella Zoster Virus (VZV) deoxyribonucleic acid (DNA)-negative in all samples taken, was considered not to have varicella and was not included in the analyses.|||VZV genome copies per sample|samples|95% Confidence Interval|Log Mean
2844192|NCT00127530|Secondary|Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity||Days 14, 42, 70, 98|||||||
2844173|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module|"The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks.~Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and Month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included).|||Hours||Standard Deviation|Mean
2844174|NCT00127842|Secondary|Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and 24 months|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed.|||days||Standard Deviation|Mean
2844175|NCT00127842|Primary|Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI|The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and 24 months|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.|||percentage of participants||95% Confidence Interval|Number
2844176|NCT00127803|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post-first vaccination|Safety assessments were on the safety population.|||Participants|||Number
2844177|NCT00127803|Primary|Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.||Day 0 and up to 7 days post each vaccination|Safety assessments were on the safety population.|||Participants|||Number
2844178|NCT00127803|Secondary|Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.|"Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.~Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA)."|Days 28, 56, 70, and 236 Post First Vaccination|Serum anti-toxin levels were assessed in the Fully Evaluable (Per-Protocol) Population.|||Participants|||Number
2844179|NCT00127790|Secondary|Depression Severity|Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.|Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)|participants who completed intervention and pre and post treatment assessments|||units on a scale||Standard Error|Mean
2844180|NCT00127790|Primary|IL-6|Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|Subjects completing blood draws to obtain plasma. One subject in the CBT-I&P condition did not complete blood draws.|||pg/mL||Standard Error|Mean
2844181|NCT00127790|Primary|Pain Severity|Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)||||units on a scale||Standard Error|Mean
2844182|NCT00127790|Primary|Insomnia Severity|Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|completed the intervention and self report instruments|||units on a scale||Standard Error|Mean
2844183|NCT00127712|Secondary|Length of Hospital Stay||Duration of hospitalization||||Days||Full Range|Median
2844184|NCT00127712|Primary|Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds||7 days||||Participants|||Number
2844185|NCT00127712|Secondary|Length of Intensive Care Unit Stay||Duration of hospitalization||||Hours||Full Range|Median
2844186|NCT00127712|Primary|Incidence of Atrial Fibrillation Requiring Treatment||7 days||||participants|||Number
2844187|NCT00127660|Primary|Energy Intake|energy content of meal ordered and consumed.|After meal||||kcal/meal||Standard Deviation|Mean
2844188|NCT00127660|Primary|Total Calories of Meal Ordered||single study visit|||||||
2844189|NCT00127608|Primary|Estimated Mean Viral Load (in log10) by Sample Types (Papule Swab, Vesicle Fluid and Vesicle Swab)|"The estimated viral load was calculated by quantitative polymerase chain reaction assay (Q-PCR) in log10, as a mean number of viral copies per sample by sample types (papule swab, vesicle fluid and vesicle swab).~As throat swabs were not stored dry and the number of crust samples was lower than that of papules and vesicles, this analysis was done only on data from vesicle fluid, vesicle swabs and papule swabs."|At Visit 1 (Day 0)|Only VZV DNA-positive samples were considered in this analysis.|||VZV genome copies per sample|samples|95% Confidence Interval|Log Mean
2844199|NCT00127439|Primary|Foot Trajectory Initial Contact|Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.|12 weeks||||degrees||Standard Deviation|Mean
2844200|NCT00127439|Primary|Stepping: Foot Trajectory Toe-off % Cycle|The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.|12 weeks||||percentage of gait cycle||Standard Deviation|Mean
2844201|NCT00127439|Primary|Stepping: Foot Trajectory Toe-Off|Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.|12 weeks||||degrees||Standard Deviation|Mean
2844202|NCT00127439|Primary|Self Selected Velocity on Treadmill|Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.|12 weeks||||m/s||Standard Deviation|Mean
2844203|NCT00127413|Primary|Clinician Administered Assessment of PTSD|This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.|Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up||||units on a scale||Standard Deviation|Mean
2844204|NCT00127231|Secondary|Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex|Number of days in the past 90 days on which participants reported having unprotected vaginal sex|Baseline to 12 month follow-up|Not all subjects participated in every follow-up interview.|||days||Standard Deviation|Mean
2844205|NCT00127231|Secondary|% of Patients Currently on Antiretroviral Therapy|number of participants who are currently receiving antiretroviral therapy/total number of participants|baseline through 1 year follow-up||||percentage of participants|||Number
2844206|NCT00127231|Secondary|HIV Clinic Appointment Adherence (Kept/Scheduled Appointments)|the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point|baseline through 1 year follow-up||||percentage of kept/scheduled appointment||Standard Deviation|Mean
2844207|NCT00127231|Primary|Number of Binge Drinking Days Out of the Past 90 Days|Number of days during the past 90 days on which women drank more than 3 standard drinks|Baseline through 12 month follow-up|Not all subjects participated in every follow-up interview.|||days out of past 90 days||Standard Deviation|Mean
2844208|NCT00127231|Primary|Number of Drinking Days Out of the Past 90 Days||Baseline through 1 year follow-up|All randomized participants were included in analyses although 6 participants from each arm did not complete the study due to loss to follow up|||days||Standard Deviation|Mean
2844209|NCT00127218|Secondary|Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)|Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded|18 months|Cardiovascular event (stroke) was seen in only 1 patient and 5 patients needed myocardial revascularization|||Participants|||Count of Participants
2844210|NCT00127218|Primary|Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries|The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.|18 months||||percentage of internal carotid artery||Standard Error|Mean
2844211|NCT00127205|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.|Patients who received at least one dose of protocol treatment.|||Participants|||Number
2844212|NCT00127205|Secondary|Distributions of Sites of First Recurrence on the Three Arms.|All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.|Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence||||Participants|||Count of Participants
2844213|NCT00127205|Secondary|Overall Survival|Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.|follow up completed every 6 months for 5 years and then annually for 5 years or until death|Only eligible patients will be included in the analysis.|||percentage of analyzable patients||95% Confidence Interval|Number
2844241|NCT00126659|Other Pre-specified|Time to Progression|Time, in weeks, after treatment until disease progresses. Repeat radiologic studies to evaluate disease progression or response after 10 weeks of BAY 43 9006 therapy.|Following 10 weeks of treatment or until disease progression|||||||
2844214|NCT00127205|Primary|Disease-free Survival|Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.|Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence|Only eligible patients will be included in the analysis.|||percentage of analyzed participants||95% Confidence Interval|Number
2844215|NCT00127192|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.|||mg/dL||95% Confidence Interval|Least Squares Mean
2844216|NCT00127192|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.|||Percent||95% Confidence Interval|Least Squares Mean
2844217|NCT00127192|Secondary|Change From Baseline in Glycosylated Albumin at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.|||Percent||95% Confidence Interval|Least Squares Mean
2844218|NCT00127166|Secondary|Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
2844219|NCT00127166|Secondary|Time to Recovery to Within 5% of Baseline FEV1|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||minutes||Inter-Quartile Range|Median
2844220|NCT00127166|Secondary|Maximum FEV1 % Predicted Following First Beta-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent of predicted value||95% Confidence Interval|Least Squares Mean
2844221|NCT00127166|Secondary|Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent times Minutes||95% Confidence Interval|Least Squares Mean
2844222|NCT00127166|Primary|Maximum Post-exercise Percent (%) Fall in FEV1|The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
2844223|NCT00127101|Secondary|Number of Participants Who Responded to Treatment|"Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.~SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400"|Every 28 days for up to 6 Months of Treatment|All patients treated|||Participants|||Number
2844224|NCT00127101|Primary|Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities|Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.|Day 1 to day 28|All Patients treated|||Participants|||Number
2844225|NCT00127062|Primary|Spirometry, Percentage Change in FEV1 From Baseline||baseline, 24 hours after||||percentage change in FEV1 from baseline||95% Confidence Interval|Mean
2844242|NCT00126659|Other Pre-specified|Overall Survival|The number of participants surviving from baseline (treatment) to death due to any cause measured in days.|Up to 2 years|||||||
2846925|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population||Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2844226|NCT00127036|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella's method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%.|30 Days After End of Treatment - Average of 6 Months|All participants.|||participants|||Number
2844227|NCT00127036|Secondary|Number of Participants Per Treatment Arm, With Overall Survival (OS)|Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.||||||
2844228|NCT00127036|Primary|Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier|Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.||||||
2844229|NCT00126776|Primary|Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)||1 yr||||events per year||95% Confidence Interval|Mean
2844230|NCT00126776|Secondary|All Cause Mortality||1 year|||||||
2844231|NCT00126776|Secondary|COPD Exacerbations Requiring Antibiotics or Corticosteroids||1 year|||||||
2844232|NCT00126776|Secondary|Quality of Life||1 year|||||||
2844233|NCT00126776|Secondary|All Cause Hospitalizations||1 year|||||||
2844234|NCT00126776|Primary|Hospitalization or Emergency Department Visit for COPD||1 yr|||||||
2844235|NCT00126750|Primary|Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators|The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).|1/1/02 - 12/31/08||||percentage of provider's patients|||Number
2844236|NCT00126737|Secondary|Stair Total (Climb, Descend)|Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.|Between Base-line and 24 Weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 1 in Weight Control Nutritional Program, 1 in Home-based exercise Program and 1 in Usual Care.|||Change in Steps||95% Confidence Interval|Mean
2844237|NCT00126737|Secondary|Walking Distance|Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 2 in Weight Control Nutritional Program.|||Change in Distance (m)||95% Confidence Interval|Mean
2844238|NCT00126737|Primary|Mental Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program and 3 in Usual Care|||Change in Score||95% Confidence Interval|Mean
2844239|NCT00126737|Primary|Physical Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 3 in the Usual Care.|||Change in score||95% Confidence Interval|Mean
2844240|NCT00126737|Primary|WOMAC Function|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 1 in Home-based exercise program and 1 in Usual Care.|||Change in Score||95% Confidence Interval|Mean
2844243|NCT00126659|Other Pre-specified|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured in days.|Following 10 weeks of treatment, followed every 2 weeks or until disease progression|||||||
2844244|NCT00126659|Primary|Efficacy of BAY 43-9006 by Evaluating Response Rate|"Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): > 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease:~Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started."|Every 2 weeks during 4 week cycle|Unable to assess response due to small sample size.||||||
2844245|NCT00126594|Post-Hoc|Best Overall Response for Participants|Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|From the date response is confirmed to the date of disease progression, first assessed 2 months (8 weeks) following start of treatment and reassessed up to 36 months (on average reassessed 12 months or less).|All participants were included per intent to treat analysis.|||participants|||Number
2844246|NCT00126594|Secondary|Duration of Response for Participants With Stable Disease (N=37) Following Treatment|Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.|From the date response is confirmed to the date of disease progression, up to 12 months|"Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met Stable Disease criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II)."|||Months||95% Confidence Interval|Median
2844247|NCT00126594|Secondary|Median Overall Survival (OS)|Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.|From the start of protocol therapy to death or date of last follow-up, up to 36 months|Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.|||Months||95% Confidence Interval|Median
2844248|NCT00126594|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months|All participants were included per intent to treat analysis.|||Months||95% Confidence Interval|Median
2844249|NCT00126594|Secondary|Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.|Up to 12 months of treatment|All participants were included in adverse event reporting per intent to treat analysis.|||participants|||Number
2844250|NCT00126594|Primary|Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)|ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.|Analysis performed for the intent-to-treat population.|||percentage of participants||95% Confidence Interval|Number
2844251|NCT00126581|Other Pre-specified|Overall Response Rate With KRAS Mutational Status|Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.|Duration of study (up to 3 years)||||percentage of participants||95% Confidence Interval|Number
2844252|NCT00126581|Other Pre-specified|Progression Free Survival With KRAS Mutation Status|Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.|Duration of study (up to 3 years)||||months||95% Confidence Interval|Median
2844253|NCT00126581|Other Pre-specified|Overall Response Rate by EGFR Mutation Status|Response and EGFR mutation status are defined in previous outcome measures.|Duration of study (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.|||percentage of participants|||Number
2844254|NCT00126581|Other Pre-specified|Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.~EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome."|Duration of treatment (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.|||months||95% Confidence Interval|Median
2844255|NCT00126581|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)||||months||95% Confidence Interval|Median
2844256|NCT00126581|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Duration of study (up to 3 years)||||participants|||Number
2844257|NCT00126581|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Duration of Study (up to 3 years)||||percentage of participants||95% Confidence Interval|Number
2844258|NCT00126581|Primary|18 Weeks Progression Free Survival (PFS) Rate|"The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.~The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated."|At 18 weeks||||percentage of participants||95% Confidence Interval|Number
2844259|NCT00126568|Secondary|Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006|The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.|27 months|Any participant that received treatment was analyzed for adverse events. Detailed information is reported in the Adverse Events data table.|||Participants|||Count of Participants
2844260|NCT00126568|Secondary|Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.||27 months|All patients on study.|||months||95% Confidence Interval|Median
2844261|NCT00126568|Secondary|Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.||27 months|All patients on study|||months||95% Confidence Interval|Median
2844262|NCT00126568|Primary|Number of Patients With Response to Treatment Measured by RECIST Criteria|Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.|at 6 months after treatment|All patients that received at least one cycle of treatment|||participants|||Number
2844263|NCT00126555|Post-Hoc|Participant Treatment Following Induction Therapy|Treatment received following two 30-day cycles (60 days) of 250 mg gefitinib given by mouth daily. Participant treatment reported as percentage of total treated participants out of total treated.|Following 60 days of Gefitinib induction treatment||||percentage of participants|||Number
2844264|NCT00126555|Other Pre-specified|Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression|Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. In addition, some participants presented with regional recurrences, which were not superficially accessible. The sample size was too small to determine the EGFR-proliferative responses activated by the AKT pathway; hence, the monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed.|Baseline|Samples were not available from all participants because the protocol specified that consenting to tissue biopsies was optional. Sample size was too small to determine EGFR-proliferative responses activated by the AKT pathway;hence, monitoring of the status of activated phospho-AKT as an independent marker of EGFR activation could not be performed.||||||
2844265|NCT00126555|Secondary|Frequency and Timing of Local and Distant Failures||From study entry to first documented local recurrence or last patient contact, assessed up to 5 years|Two participants did not complete study treatment (Surgery + Radiotherapy) of 17 progressed and was removed from the study.|||participants|||Number
2844266|NCT00126555|Secondary|Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)|Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): >/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.|Up to 5 years|One participant of 23 enrolled withdrew prior to treatment.|||participants|||Number
2844267|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.|||participants|||Number
2844268|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.|||participants|||Number
2844269|NCT00126555|Primary|Number of Participants With Response Rate During Induction, Dose Escalation, and Concomitant With Radiation.|Completion Induction phase, participants are evaluated for clinical response and resectability. Resectable participants who had achieved at least stable disease and received surgery followed by radiation. Unresectable participants who had achieved at least stable disease received concomitant radiation/Gefitinib.|Up to 100 days||||Participants|||Count of Participants
2844270|NCT00126555|Primary|Early Progression Rate|Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.|Baseline to 60 days, up to 2 courses of induction therapy||||percentage of participants|||Number
2844271|NCT00126503|Primary|Objective Response|Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive|Every 8 weeks to date of progression|Patients available for measurement of response to treatment with regimen. 7 Phase I and 4 Phase II patients were not available for measurement of response, respectively: disease progression (5, 2), complicating disease (1, 0), death on-study (1, 0), toxicity (0, 1), and alternative treatment (0, 1). All were counted as clinical progression.|||participants|||Number
2844272|NCT00126503|Primary|Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)|The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab|||mg/kg|||Number
2844273|NCT00126503|Secondary|Progression-free Survival|Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.|on-study to date of progression or last date known alive without progression|All patients who underwent treatment. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.|||months||Full Range|Median
2844274|NCT00126503|Secondary|Overall Survival|Months from date on-study to expired or last date known alive|on-study to date of expired or last date known alive|All treated patients available for determination of overall survival. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.|||months||Full Range|Median
2844275|NCT00126503|Primary|Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab|||mg|||Number
2844276|NCT00126490|Secondary|Number of Participants With Possibly Related Serious Adverse Events (SAEs)|Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 30 days after completion of treatment|All Participants who received at least one treatment|||participants|||Number
2844277|NCT00126490|Secondary|Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function|Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.|At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment|This was not evaluable because there were not enough samples.||||||
2844278|NCT00126490|Secondary|Number of Evaluable Participants With Progression Free Survival (PFS)|Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 2 years|Evaluable participants|||participants|||Number
2844279|NCT00126490|Secondary|Number of Evaluable Participants With Overall Survival (OS) at 2 Years|Overall Survival tabulation at 2 years from start of treatment.|2 years from start of treatment|Evaluable participants|||participants|||Number
2844280|NCT00126490|Primary|Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year|Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|1 year|All Participants who received at least one treatment|||participants|||Number
2844281|NCT00126438|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events. Data analysis to assess the relative hazard of an adverse cardiac event was performed only on HF participants categorized into 2 groups with H/M <1.6 and H/M ≥1.6 using a Cox proportional hazards model.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population included 444 participants in HF group who received IMP and had a diagnostic (optimal/sub-optimal) 3 hour 50 minute planar image. Primary efficacy analysis was based on comparing only “Adreview HF” participants with low vs. high H/M and, therefore, did not include “Adreview Control” group.|||number of adverse cardiac events|||Number
2844282|NCT00126425|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population was 520 participants in HF group who received IMP and had a diagnostic (optimal or sub-optimal) 3 hour 50 minute planar image. Images from 2 HF participants were inadvertently not submitted and not presented to blinded readers. Here, N=efficacy population and n=number of participants assessed by specific readers.|||number of adverse cardiac events|||Number
2844283|NCT00126191|Secondary|Disease Free Survival|Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.|Until disease progression up to 120 months|One low-risk participant was lost to follow-up after 48 months of disease free survival.|||Months||Full Range|Mean
2844284|NCT00126191|Primary|Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt|"Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed.~Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable.~Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment."|3 years||||participants|||Number
2844285|NCT00126126|Secondary|Six-minute Walk Test|The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters.|8 weeks for intervention and wait list control group|Repeated Measures ANOVA|||meters||Standard Deviation|Mean
2844286|NCT00126126|Primary|Amputee Mobility Predictor|The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points.|8 weeks for intervention and for wait-list control|Repeated Measures ANOVA|||Points||Standard Deviation|Mean
2844287|NCT00126113|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome).|Day 70 (end of study)||||units on a scale||Standard Deviation|Mean
2844336|NCT00125268|Secondary|Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment|The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.|baseline, 4 weeks|||||||
2846926|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population||Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2844288|NCT00126113|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ' Always ' to ' Never ' with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability).|Day 70 (end of study)||||units on a scale||Standard Deviation|Mean
2844289|NCT00126113|Secondary|Hearing Handicap Inventory (HHI)|HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap).|Day 70 (end of study)||||units on a scale||Standard Deviation|Mean
2844290|NCT00126113|Primary|Psychosocial Impact of Assistive Devices Scale (PIADS)|PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being.|Day 70 (end of study) only||||units on a scale||Standard Deviation|Mean
2844291|NCT00125957|Primary|Hamilton Depression Rating Scale (HAM-D)|Median total depression ratings at baseline and follow-up using the HAM-D. The scale consists of 21 questions that assess depression symptoms. Questions 1-3, 7-11, 15, and 19 are rated on a scale of 0-4, with 0 being not present to and 4 being severe. Questions 4, 5, 12 - 14, 16-18 and 21 are rated from 0-2 with a score of 0 signifying the symptom is absent and a score of 2 as most severe. Item 20 is score on a scale of 0-3 with the same pattern of severity as all other questions. The total score for the HAM-D ranges from 0-63.|Baseline and follow-up||||units on a scale||Full Range|Median
2844292|NCT00125957|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Median total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.|Baseline and follow-up||||units on a scale||Full Range|Mean
2844293|NCT00125931|Secondary|YMRS Scores|Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|Each morning of the three-day study||||units on a scale||Standard Deviation|Mean
2844294|NCT00125931|Primary|Mania Symptoms Using MACS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered||||units on a scale||Full Range|Mean
2844295|NCT00125853|Secondary|BMI|Body weights and heights were taken at the beginning and end of each treatment period.|Before and after 8 weeks of treatment||||kg/m^2||Standard Deviation|Mean
2844296|NCT00125853|Secondary|HbA1c|Fasting blood samples were taken at the beginning and end of each treatment period.|Before and after 8 weeks of treatment||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2844297|NCT00125853|Secondary|Total Cholesterol|Fasting blood samples were taken at the beginning and end of each treatment period.|Before and after 8 weeks of treatment||||mmol/L||Standard Deviation|Mean
2844298|NCT00125853|Secondary|24 Hour Systolic Blood Pressure|The 24-h Ambulatory Blood Pressure Monitoring (ABPM) was recorded at the beginning and end of each beta-blocker treatment period. BP was automatically recorded for 24 h at 30 min intervals. The time periods from 0700h to 2200h and from 2200h to 0700h were defined as daytime and night-time, respectively.|Before and after 8 weeks of treatment||||mmHg||Standard Deviation|Mean
2844299|NCT00125853|Primary|Insulin Sensitivity Index (ISI)|"Patients were asked to fast for a minimum of 12 hours prior to each oral glucose tolerance test (OGTT). Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load. For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing.~For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing."|Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment|Patients with mild-to-moderate essential hypertension, aged 18 years or above, with blood pressure controlled to <140/85 mmHg on a maximum of two antihypertensive drugs, were recruited from the Peart-Rose Hypertension clinic at St Mary’s Hospital in West London and from local general practices.|||factor||Inter-Quartile Range|Mean
2844300|NCT00125762|Primary|Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4)|95% CI for Metavir Fibrosis stage 0 -1 consistent with no or mild fibrosis compared to Metavir 2 - 4 which represents significant fibrosis or cirrhosis|Liver Biopsy and VCTE within a time frame of 6 months|456 patients with matching liver biopsy and fibroscan|||ROC area||95% Confidence Interval|Mean
2844301|NCT00125762|Primary|Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)|VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.|28 days|748 patients were eligible for analysis with matching valid liver biopsies and VCTE measurements.|||ROC area||95% Confidence Interval|Mean
2844302|NCT00125658|Secondary|Movement Smoothness|"Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or jerky movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline."|baseline, 10 weeks, 20 weeks||||sub movements||Standard Deviation|Mean
2844303|NCT00125658|Secondary|Movement Accuracy (Reach Path Ratio, RPR)|Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||ratio||Standard Deviation|Mean
2844304|NCT00125658|Primary|Upper-extremity Fugl-Meyer Motor Assessment|The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||units on a scale||Standard Deviation|Mean
2844305|NCT00125658|Secondary|Movement Speed|peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||cm/s||Standard Deviation|Mean
2844306|NCT00125658|Primary|Change in Elbow Extension Range of Motion|joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||degrees||Standard Deviation|Mean
2844307|NCT00125658|Primary|Change in Shoulder Flexion|joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||degrees||Standard Deviation|Mean
2844308|NCT00125658|Primary|Change in Trunk Displacement|Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.|baseline, 10 weeks, 20 weeks||||centimeters||Standard Deviation|Mean
2844309|NCT00125619|Secondary|Berg Balance Scale|Clinical measure of balance|4 weeks||||units on a scale||Standard Deviation|Mean
2844310|NCT00125619|Secondary|Short Physical Performance Battery|Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.|4 weeks||||units on a scale||Standard Deviation|Mean
2844311|NCT00125619|Secondary|Lower Extremity Fugl-Meyer Motor Assessment|Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.|4 weeks||||units on a scale||Standard Deviation|Mean
2844312|NCT00125619|Secondary|Step Length Ratio (Abs)|measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]|4 weeks||||ratio||Standard Deviation|Mean
2844313|NCT00125619|Secondary|Six Minute Walk|distance, in meters, walked overground over a six minute interval.|4 weeks||||meters||Standard Deviation|Mean
2844314|NCT00125619|Secondary|Fast Walking Speed|Fastest comfortable walking speed measured while walking overground|4 weeks (s/p 12 training sessions)||||meters/s||Standard Deviation|Mean
2844315|NCT00125619|Primary|Self-selected Overground Walking Speed|Overground walking speed determined as rate of walking over a 10 meter distance.|4 weeks (s/p 12 sessions of locomotor training)||||meters/s||Standard Deviation|Mean
2844316|NCT00125593|Secondary|End-stage Renal Disease Among All Patients Not on Dialysis at the Time of Randomization to Simvastatin Plus Ezetimibe Versus Placebo|End-stage renal disease was defined as initiation of maintenance dialysis or renal transplantation. Temporary dialysis was excluded. All potential dialysis and transplant events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
2844317|NCT00125593|Secondary|Coronary or Non-coronary Revascularization Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Revascularization included any arterial revascularization procedure, whether surgical or percutaneous, but excluded revascularization performed for hemodialysis vascular access (e.g. fistuloplasty) or to the donor kidney transplant artery. Revascularization included amputations for vascular disease (rather than for trauma or infection). All potential revascularization events (including angiography) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
2844318|NCT00125593|Secondary|Non-hemorrhagic Stroke Among All of Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Stroke was defined as rapid onset of focal or global neurological deficit, with duration greater than 24 hours. Clinical notes and brain imaging were sought to determine the stroke etiology, and if the stroke was fatal and post-mortem examination findings were available, this information was also assessed. All potential stroke events (including transient ischemic attack and intracerebral hemorrhage) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
2844420|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|BL, Day 169|All treated participants|||IU/mL||Standard Deviation|Mean
2844319|NCT00125593|Secondary|Major Coronary Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major coronary events defined as coronary death or non-fatal myocardial infarction. Myocardial infarction adjudicated based on the presence of serial changes in cardiac biomarkers (e.g. troponin, creatine kinase), typical ECG changes and typical cardiac symptoms. If myocardial infarction was fatal and post-mortem examination findings were available, this information was also assessed. All potential coronary events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
2844320|NCT00125593|Secondary|Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome)|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|Includes only those patients initially randomized to simvastatin plus ezetimibe versus placebo (as opposed to all patients ever randomized to simvastatin plus ezetimibe versus all patients allocated placebo)|||participants|||Number
2844321|NCT00125593|Secondary|Major Vascular Events Analyzed Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
2844322|NCT00125593|Primary|Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major atherosclerotic events defined as non-fatal myocardial infarction or coronary death, non-hemorrhagic stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years||||participants|||Number
2844323|NCT00125528|Secondary|McGill Pain Questionnaire (MPQ)|Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.|6 weeks||||units on a scale||Standard Deviation|Mean
2844324|NCT00125528|Primary|Change in Numeric Rating Scale (NRS-11)|Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.|6 weeks||||units on a scale||Standard Deviation|Mean
2844325|NCT00125515|Primary|Retention in Treatment|The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.|Number of participants who complete 12 weeks of treatment|All analysis were conducted based on intent-to-treat principle.|||participants|||Number
2844326|NCT00125372|Secondary|Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response||Baseline and 9 days|The numbers analyzed are represented in the rows by EGFR status at baseline. Eight participants had wild-type EGFR at baseline, one had a mutation at Exon 21, and one participant's EGFR status was not assessed at baseline. The total of all rows matches the overall number analyzed; 10.|||Participants|||Count of Participants
2844327|NCT00125372|Secondary|Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels||At 9 days|The testing necessary to determine the correlation documented in this outcome was not performed due to budget constraints.||||||
2844328|NCT00125372|Primary|Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)||Baseline and 9 days||||Participants|||Count of Participants
2844329|NCT00125372|Primary|Number of Participants With Change in Expression Level of Cyclin D1||Baseline and 9 days||||Participants|||Count of Participants
2844330|NCT00125372|Primary|Number of Participants With Change in Expression Level of EGFR.||Baseline and 9 days||||Participants|||Count of Participants
2844331|NCT00125359|Secondary|Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses.||Through study completion, an average of 1 year|Three patients had biopsies evaluated for EGFR mutations.|||Participants|||Count of Participants
2844332|NCT00125359|Secondary|Progression-free Survival and Overall Survival||Through study completion, an average of 1 year||||Weeks||Full Range|Median
2844333|NCT00125359|Secondary|Correlation of Early PET Responses With Objective Radiographic Responses.|PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Through study completion, an average of 1 year|Number of participants analyzed is reported per achieved disease response noted in individual rows.|||Participants|||Count of Participants
2844334|NCT00125359|Primary|Radiographic Response Rates|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Through study completion, an average of 1 year||||Participants|||Count of Participants
2844335|NCT00125268|Secondary|Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment|The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.|baseline, 4 weeks|||||||
2844337|NCT00125268|Primary|Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment|Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.|baseline, 4 weeks|||||||
2844338|NCT00125242|Primary|Word Retrieval Accuracy|"Accuracy of naming of pictured treated and untreated items was assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to follow-up (6 weeks following treatment). All naming responses were scored using a 0-10 scale reflecting promptness and presence of errors; scores of 8-10 received an accuate score and scores of 0-7 received an inaccurate score. A percentage accuracy score was calculated for each experimental set of items for every probe session. Baseline probe scores were compared to end of treatment and follow-up probe scores to obtain individual effect sizes for each experimental list of items for each participant (i.e., several effect sizes were calculated for each participant). All effect sizes were utlized to obtain an average effect size for each participant; these averages were then utlized to obtain a group average."|End of treatment and at 6 weeks post treatment|SFA Treatment Participants were stroke-survivors with chronic aphasia who had significant word retrieval difficulties. Non Treatment Stimuli Development Participants were only enrolled in the study to provide data for the development of treatment stimuli. As such, they were not assessed for the outcome measure.|||d-index (effect size)|Participants|Standard Deviation|Mean
2844339|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 34 - 86 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 86 were included in the analysis.|||cm/yr||Standard Deviation|Mean
2844340|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 0 - 34 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 0 -34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 34 were included in the analysis.|||cm/yr||Standard Deviation|Mean
2844341|NCT00125190|Secondary|rhIGF-1 Doses Required to Achieve the Serum IGF-1 Targets With Measures Taken at Each Study Visit||34, 52 and 86 weeks|||||||
2844342|NCT00125190|Secondary|Percent Changes in Serum Concentration of Acid Labile Subunit (ALS) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of Serum Concentration of Acid Labile Subunit (ALS).|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.|||percent||Full Range|Median
2844343|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-3 (IGFBP-3) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.|||percent||Full Range|Median
2844344|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-2 (IGFBP-2) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-2 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.|||percent||Full Range|Median
2844345|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-1 (IGFBP-1) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-1 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 34 measurements were included in the analysis.|||percent||Full Range|Median
2844346|NCT00125190|Primary|Height Velocity Over the Study Period 34 - 86 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 to 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.|||cm/yr||Standard Deviation|Mean
2844347|NCT00125190|Secondary|Bone Age - Change From Pretreatment Minus Change in Chronological Age Over the Study Period 0 - 86 Weeks [Intent to Treat Population]|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Weeks 0 - 86|Subjects who had both baseline and week 86 measurements were included in the analysis.|||years||Standard Deviation|Mean
2844348|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 34 - 86 Weeks|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.|||SDs||Standard Deviation|Mean
2844349|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 0 - 34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.|||SDs||Standard Deviation|Mean
2844350|NCT00125190|Primary|Height Velocity Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|34 weeks|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.|||cm/yr||Standard Deviation|Mean
2844351|NCT00125164|Post-Hoc|Change From Baseline in Height Standard Deviation (SD) Score at One Year - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||SD/year||Standard Deviation|Mean
2844352|NCT00125164|Post-Hoc|Height Velocity During the First Year for Subjects - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||cm/year||Standard Deviation|Mean
2844353|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||mg/dL||Standard Deviation|Mean
2844354|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||ng/mL||Standard Deviation|Mean
2844355|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
2844356|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year|Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
2844357|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year|Blood sample was collected for measuring the level of IGF-2 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
2844358|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Percent change||Standard Deviation|Mean
2844359|NCT00125164|Secondary|Changes in Bone Age From Baseline to One Year|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||Year||Standard Deviation|Mean
2844360|NCT00125164|Secondary|Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Measured at baseline and at one year|A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||SD/year||Standard Deviation|Mean
2844421|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.|BL, Day 169|All treated participants|||mg/dL||Standard Deviation|Mean
2844361|NCT00125164|Primary|Height Velocity During the First Year - Intent to Treat (ITT)Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Measured at baseline and at one year|A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.|||cm/yr||Standard Deviation|Mean
2844362|NCT00125138|Secondary|Investigator/Caregiver Evaluations of Motor Function|The change in the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.|||Scores on a scale||Standard Deviation|Mean
2844363|NCT00125138|Primary|Patient Evaluation of Symptoms of Psychosis.|The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.|||Scores on a scale||Standard Error|Least Squares Mean
2844364|NCT00125034|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008|Safety Population|||participants|||Number
2844365|NCT00125034|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
2844366|NCT00125034|Secondary|Disease Control Rate (Cut Off Date 4 August 2006)|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||percentage of participants||95% Confidence Interval|Number
2844367|NCT00125034|Secondary|Participants With No Residual Tumor After Metastatic Surgery|No residual tumor after on-study surgery for metastases.|Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||participants|||Number
2844368|NCT00125034|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Mutant population|||months||95% Confidence Interval|Median
2844369|NCT00125034|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Wild-Type population|||months||95% Confidence Interval|Median
2844370|NCT00125034|Secondary|Overall Survival Time|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
2844371|NCT00125034|Secondary|Progression-free Survival Time (KRAS Mutant Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Mutant population|||months||95% Confidence Interval|Median
2844372|NCT00125034|Secondary|Progression-free Survival Time (KRAS Wild-Type Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Wild-Type population|||months||95% Confidence Interval|Median
2844434|NCT00124943|Secondary|Late Lumen Loss|"Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography.~Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up."|Day 0 (post-procedure baseline) and 6 months.|"Treated population for whom data was available (indicated by n)."|||mm||Standard Deviation|Mean
2844373|NCT00125034|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||months||95% Confidence Interval|Median
2844374|NCT00125034|Secondary|Best Overall Response Rate (KRAS Mutant Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Mutant population|||percentage of participants||95% Confidence Interval|Number
2844375|NCT00125034|Secondary|Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Wild-Type population|||percentage of participants||95% Confidence Interval|Number
2844376|NCT00125034|Primary|Best Overall Response Rate - Independent Review Committee (IRC)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on the Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).|||percentage of participants||95% Confidence Interval|Number
2844377|NCT00124982|Secondary|LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-813|Treated participants with available serum samples for assay|||participants|||Number
2844378|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.|BL (Day 0), Days 365, 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
2844379|NCT00124982|Secondary|Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term|SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365 and 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
2844380|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
2844381|NCT00124982|Secondary|Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements.|||participants|||Number
2846927|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population|Measured by DXA.|Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2844382|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
2844383|NCT00124982|Secondary|Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
2844384|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
2844385|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
2844386|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
2844387|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||mg/dL||Standard Error|Mean
2844388|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||mg/dL||Standard Deviation|Mean
2844435|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to Month 6.|Treated population.|||participants|||Number
2845374|NCT00116779|Secondary|Median Prostate-Specific Antigen Values at Various Study Timepoints|Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.|Baseline, Days 3, 14, 28, 84, 364|ITT population|||nanogram / milliliter||Full Range|Median
2844389|NCT00124982|Secondary|Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||swollen joints||Standard Error|Mean
2844390|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||swollen joints||Standard Deviation|Mean
2844391|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||tender joints||Standard Error|Mean
2844392|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||tender joints||Standard Deviation|Mean
2844393|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Error|Mean
2844394|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time|||units on a scale||Standard Deviation|Mean
2844395|NCT00124982|Secondary|Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. n=number of evaluable participants.|||participants|||Number
2844396|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL, Day 169|All treated participants|||units on a scale||Standard Deviation|Mean
2844397|NCT00124982|Secondary|Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL|All treated participants|||units on a scale||Standard Deviation|Mean
2844436|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to 1 Month.|Treated population.|||participants|||Number
2844398|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL, Day 169|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2844399|NCT00124982|Primary|Long-term Period: Mean Temperature (T) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable temperature readings.|||degrees Celsius||Standard Deviation|Mean
2844400|NCT00124982|Primary|Long-term Period: Mean Heart Rate (HR) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable heart rate readings.|||beats per minute||Standard Deviation|Mean
2844401|NCT00124982|Primary|Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure readings.|||mm Hg||Standard Deviation|Mean
2844402|NCT00124982|Primary|Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure measurements.|||mm Hg||Standard Deviation|Mean
2844403|NCT00124982|Primary|LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time|Na NR=132 - 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 - 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 - 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||mEq/L||Standard Deviation|Mean
2844404|NCT00124982|Primary|Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time|Bilirubin NR=0.2-1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0-24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4-1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8-10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8-4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||mg/dL||Standard Deviation|Mean
2844405|NCT00124982|Primary|Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time|HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||U/L||Standard Deviation|Mean
2844406|NCT00124982|Primary|Long-term Period: Change From Baseline in White Blood Cells Over Time|Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||10^3 c/uL||Standard Deviation|Mean
2844407|NCT00124982|Primary|Long-term Period: Change From Baseline in Platelets (PLT) Over Time|Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||10^9 c/L||Standard Deviation|Mean
2844408|NCT00124982|Primary|Long-term Period: Change From Baseline in Erythrocytes Over Time|Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||10^6 c/uL||Standard Deviation|Mean
2844409|NCT00124982|Primary|Long-term Period: Change From Baseline in Hematocrit Over Time|The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||percentage change||Standard Deviation|Mean
2844410|NCT00124982|Primary|Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time|HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.|||g/dL||Standard Deviation|Mean
2844432|NCT00124982|Primary|Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|Days 1-169|All treated participants|||participants|||Number
2844411|NCT00124982|Primary|Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
2844412|NCT00124982|Primary|Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
2844413|NCT00124982|Primary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase (GGT): >2*ULN, or if BL>ULN, use >3*BL; bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen (BUN): >2*BL; creatinine: >1.5*BL|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
2844414|NCT00124982|Primary|Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes:<0.75*BL; Platelets: <0.67*LLN/>1.5 * ULN, or if BL<LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results.|||participants|||Number
2844415|NCT00124982|Primary|Long-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants|||participants|||Number
2844416|NCT00124982|Primary|Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants|||participants|||Number
2844417|NCT00124982|Secondary|Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2844418|NCT00124982|Secondary|Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Day 169|All treated participants|||participants|||Number
2844419|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).|BL, Day 169|All treated participants|||units on a scale||Standard Deviation|Mean
2844422|NCT00124982|Secondary|Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2844423|NCT00124982|Secondary|Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2844424|NCT00124982|Primary|Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-169|Treated participants with available serum samples for assay|||participants|||Number
2844425|NCT00124982|Primary|Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure||Day 1 (Baseline) -Day 169|Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data.|||mm Hg||Standard Deviation|Mean
2844426|NCT00124982|Primary|Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
2844427|NCT00124982|Primary|Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
2844428|NCT00124982|Primary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.|||participants|||Number
2844429|NCT00124982|Primary|Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Days 1-169|Participants who received at least 1 infusion of abatacept during the short-term treatment period|||participants|||Number
2844430|NCT00124982|Secondary|Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Day 169|All treated participants.|||participants|||Number
2844431|NCT00124982|Primary|Short-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Days 1-169|All treated participants|||participants|||Number
2844433|NCT00124943|Secondary|Percentage of In-Stent Volume Obstruction at 6 Months|In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume * 100.|6 months|Treated population for whom data was available.|||Percentage of obstruction||Standard Deviation|Mean
2844437|NCT00124943|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was assessed by quantitative coronary angiography and defined as >50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.|6 months|Treated Population.|||percentage of participants|||Number
2844438|NCT00124943|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.~An SAE is any event that:~is fatal or life threatening~results in persistent or significant disability or or incapacity;~requires or prolongs existing hospitalization;~is a congenital anomaly/birth defect in the offspring of a patient who received medication;~conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above."|Up to 6 months.|Treated population.|||participants|||Number
2844439|NCT00124943|Primary|Number of Participants With Procedural Complications|"Procedural complications include the following:~Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes;~Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia;~Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema;~Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow;~Clinical changes: chest pain."|From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).|Treated population.|||participants|||Number
2844440|NCT00124943|Primary|Phase I: Number of Participants With Dose-limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting.~The maximum tolerated dose was defined as the lesser of 45 mg/m^2 or the dose at which any drug related toxicities were observed."|Up to 1 week following percutaneous coronary intervention.|Phase I treated population.|||participants|||Number
2844441|NCT00124917|Other Pre-specified|Long-term Effects and Toxicity Following Selective Intra-prostatic Dose Escalation|Acute and late toxicity will be assessed by the Radiation Therapy Oncology Group (RTOG) Acute and Late Toxicity Genitourinary (GI)/Gastrointestinal (GU) scales.|completion of therapy|This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.||||||
2844442|NCT00124917|Other Pre-specified|Correlate Toxicity With Genomic and Proteomic Analyses|Genomic and proteomic analyses will be conducted on a gene by gene basis using a 2-sample t-test at the 0.001 level and correlated with toxicity.|Completion of therapy|This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.||||||
2844443|NCT00124917|Other Pre-specified|Radiation Response With Genomic and Proteomic Analyses|Genomic and proteomic analyses will be conducted on a gene by gene basis using a 2-sample t-test at the 0.001 level and correlated with radiation response.|completion of therapy|This outcome measure was not done because the study was closed due to unanticipated toxicity and risks to subjects.||||||
2844444|NCT00124917|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTC v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|53 months and 20 days|All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards.|||Participants|||Count of Participants
2844445|NCT00124917|Primary|Maximum Tolerated Dose (MTD) of External Beam Radiation|Maximum tolerated dose is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experienced a dose limiting toxicity attributed to radiation therapy.|12 weeks after radiation therapy (RT)|This outcome measure was not done. All 6 participants enrolled in this trial received a dose of 7560 cGy and are grouped together in one Arm/Group. An attempt was made to escalate to the next higher dose but we were unable to treat patients and maintain safety standards.||||||
2844446|NCT00124748|Secondary|Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes||12 months|Due to the small number of diabetic patients enrolled into the study, the analysis was never done.|||Participants|||Number
2844447|NCT00124748|Secondary|Time to First Complete Molecular Response (CMR)]|Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene.|48 months overall|This analysis was not done because no major molecular improvement was observed in the 800mg dose compared to 400mg dose. Hence, analysis for complete molecular response was not necessary.|||Months||95% Confidence Interval|Median
2844448|NCT00124748|Secondary|Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)|A Landmark Kaplan-Meier analysis was performed for PFS at 42 months by MMR status at 6, 12, and 18 months to investigate their prognostic value.|42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment. Patients without a valid polymerase chain reaction (PCR) assessment or those who had experienced an event before the landmark were excluded from analysis|||Percent probability||95% Confidence Interval|Number
2844449|NCT00124748|Secondary|Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12|Imatinib PK trough plasma concentration (Cmin) was defined as any pre-dose Imatinib plasma concentration|Month 12|Pharmakokinetic (PK) population consisted of number of patients with a pre-dose PK sample at Month 12|||mg/mL||Standard Deviation|Mean
2844450|NCT00124748|Secondary|Mean Actual Dose Intensity Per Day|The mean actual dose intensity per day from start of treatment up to last dose or discontinuation was evaluated up to Month 36. Actual dose intensity (mg/day) = total dose/time on treatment (periods of zero dose are included)|start of treatment to Month 36|Safety analysis population (SAP): consisted of all patients who received at least one dose of study medication.Subjects are summarized according to the safety treatment allocation (the dose they actually received).|||mg/day||Standard Deviation|Mean
2844451|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)|Duration of CCyR was defined as the time between date of CCyR and the earliest of either (1) loss of CCyR OR (2) (Chronic Myeloid Leukemia) CML-related death or progression to (Accelerated Phase/Blast Crisis) AP/BC during study treatment. Estimated rate of duration of first CCyR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From first complete cytogenetic response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
2844452|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss|Duration of MMR (months) = (date of first confirmed loss or censoring - date of MMR + 1 ) / 30.4375. Estimated rate of duration of first MMR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From First major molecular response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
2844453|NCT00124748|Secondary|Estimated Rate of Overall Survival (OS) in Two Treatment Arms|OS was defined as time between randomization and death due to any cause during study treatment or during follow-up after discontinuation of treatment. Estimated rate of OS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
2844454|NCT00124748|Secondary|Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms|(Accelerated Phase/Blast Crisis) AP/BC was defined as time between randomization and either (1) (Chronic Myeloid Leukemia) CML-related death (if death was primary reason for discontinuation) or (2) progression to AP or BC (during treatment). Estimated rate of AC/BC was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
2844455|NCT00124748|Secondary|Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms|PFS on study which was defined as time between randomization and either (1) death due to any cause on treatment of during follow-up after discontinuation of treatment or (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment during follow-up after discontinuation of study treatment. Estimated rate of PFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
2844456|NCT00124748|Secondary|Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms|EFS on treatment was defined as time between randomization and either (1) death due to any cause during study treatment, (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment, (3) loss of complete hematological response (CHR), or (4) loss of major cytogenic response (MCyR) while on treatment. Estimated rate of EFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percent probability||95% Confidence Interval|Number
2844457|NCT00124748|Secondary|Time to First Complete Hematological Response (CHR)]|Complete Hematological Response (CHR) is defined is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement. Time to CHR (months) = (date of first CHR or censoring - date of randomization + 1) / 30.4375. Time to first CHR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Months||95% Confidence Interval|Median
2844458|NCT00124748|Secondary|Time to First Complete Cytogenetic Response|Cytogenetic response (CyR) is the percentage of Philadelphia positive metaphases (among at least 20 metaphase cells in Bone Marrow) with Complete Cytogenetic Response (CCyR) being 0 percent. Time to CCyR (months) = (date of first CCyR or censoring - date of randomization + 1) / 30.4375. Time to first CCyR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Months||95% Confidence Interval|Median
2844459|NCT00124748|Secondary|Time to First Major Molecular Response|"MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).~Time to MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. Time to first MMR was evaluated using the Kaplan-Meier method"|42 months overall|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment.|||Months||95% Confidence Interval|Median
2844460|NCT00124748|Secondary|Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts|"Undetectable levels or Complete molecular response is defined as Bcr-Abl ratio (%) on international scale (IS) <= 0.0032% (≥ 4.5 log reduction of BCR-Abl transcripts from a standardized baseline)."|12 , 24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized into the study.|||Percentage of Partcipants|||Number
2844461|NCT00124748|Secondary|Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months|Complete Hematologic Response (CHR) is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement.|12, 24, 36, and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of participants|||Number
2844462|NCT00124748|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months|Cytogenetic response (CyR)is the percentage of Philadelphia chromosome positive metaphases (among at least 20 metaphase cells in bone marrow (BM)) with Complete Cytogenetic Response (CCyR) being 0 percent.|12, 24, 36, 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of Participants|||Number
2844463|NCT00124748|Secondary|Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of participants|||Number
2844464|NCT00124748|Primary|Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|12 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.|||Percentage of participants|||Number
2844465|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%|The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population|||minutes||Standard Deviation|Mean
2844466|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%|The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population|||minutes||Standard Deviation|Mean
2844467|NCT00124735|Secondary|Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%|The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population|||minutes||Standard Deviation|Mean
2844468|NCT00124735|Primary|Total Dose of Zemuron (Rocuronium) Administered|Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set)|during surgery|Per protocol population|||mg/kg||Standard Deviation|Mean
2844469|NCT00124709|Secondary|Patient/Caregiver Quality of Life|Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.|From Baseline to Visit 5 , 6, 8, 10, 12, and 14|Intent-to-Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|||Scores on PIQoL-AD Scale||Standard Deviation|Mean
2844470|NCT00124709|Secondary|Atopic Dermatitis (AD) Remission Time|"Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response (yes) to the question No or almost no eczema? and a response of no treatment except emollients to the question Medication used."|36 month Double-Blind Phase|Intent-to-Treat population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|||Days||Standard Deviation|Mean
2844471|NCT00124709|Secondary|Corticosteroid and Pimecrolimus Drug Use|"Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.~Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months."|48 months|Safety population: all randomized patients who were dispensed study medication.|||Days of Exposure||Standard Deviation|Mean
2844472|NCT00124709|Secondary|Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies|"Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.~Note: The results at six years are not reported due to early termination of the study."|6 years (36 month Double-Blind Phase)|Intent to Treat Population defined as all randomized patients who were dispensed study medication and had at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
2844473|NCT00124709|Secondary|Long Term Safety in Infants and Young Children|Note: The results of this secondary outcome is not reported due to early termination of the study.|6 years|||||||
2844474|NCT00124709|Primary|Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age|Note: The results for this efficacy variable are not reported due to early termination of the study.|6 years|||||||
2844475|NCT00124709|Primary|Atopic Dermatitis (AD) Disease Control Over 36 Months|Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|36 months|Intent to Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|||Proportion of disease free days||Standard Deviation|Mean
2844476|NCT00124657|Secondary|Number of Participants Experiencing Grade 3 or 4 Toxicity Events|Adverse events were collected systematically for each of the 44 Phase II participants from the time of enrollment to the completion of therapy (approximately 2 years from start of therapy).|From start of therapy through 2 years.|All 44 Phase II participants were evaluated. Eight of 16 participants with lymphopenia received dexamethasone within 4 weeks of the recorded toxicity. In both participants with headache, there was a documented progressive disease within 3 days of the recorded headache.|||Participants|||Number
2844477|NCT00124657|Secondary|Plasma and CSF Levels of VEGF, bFGF, and SDF1|This objective was to determine the plasma and CSF levels of the VEGF, bFGF, and SDF1 at diagnosis, and the plasma levels of these factors at regular intervals during therapy, and to analyze the association of these results with tumor response.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.||||||
2846928|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population|Measured by DXA.|Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2844478|NCT00124657|Secondary|To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity||5 Years|This objective became obsolete over the course of the protocol, and data was not collected.||||||
2844479|NCT00124657|Secondary|Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment|This objective was to prospectively investigate the correlation between standard magnetic resonance imaging (MRI) and investigational radiologic techniques (MR spectroscopy, perfusion/diffusion, PET scan, DEMRI/BLAST) in assessing tumor response to this treatment.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.||||||
2844480|NCT00124657|Secondary|Ability of Erlotinib to Inhibit EGFR Signaling|"The objective was to test the ability of erlotinib to inhibit the EGFR signaling in patients with high-grade glioma who required a second surgery.~This outcome was not assessed due to insufficient availability of tumor and control samples for analysis."|5 Years|This outcome was not assessed due to insufficient availability of tumor and control samples for analysis.||||||
2844481|NCT00124657|Primary|Progression Free Survival (PFS)|"Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause.~PFS was not calculated for the other disease types."|1 and 2 years after end of therapy|Per protocol, 41 participants with either anaplastic astrocytoma or glioblastoma multiforme were analyzed for this outcome.|||years||Standard Deviation|Mean
2844482|NCT00124657|Primary|Maximum Tolerated Dose (MTD) of Erlotinib|MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD.|During the first 8 weeks of therapy.|22 participants were analyzed for MTD over 4 dose levels. One of 23 enrolled participants was not evaluable due to early disease progression.|||mg/m^2|||Number
2844483|NCT00124657|Secondary|Number of Positive Mutations of EGFR and Downstream Pathways|"Statistical analyses of genomic changes, expression profiles and validation studies should be considered in an exploratory and hypothesis-generating context.~Fresh frozen tumor tissue was obtained at the time of tumor resection and diagnosis. DNA was extracted from formalin-fixed, paraffin-embedded tissue. The entire PTEN coding sequence (exons 1-9), exons 1, 9 and 20 of PIK3CA, and exons 17-24 of EGFR were evaluated using exon-specific PCR amplification, and immunohistochemistry was done. Tumor lesions were considered positive if >25% cells were immunoreactive."|Once at tumor resection and diagnosis|Unstained slides were available for immunohistochemistry analysis in 21 of the 23 Phase I participants.|||participants|||Number
2844484|NCT00124657|Secondary|AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.|||mg*h/mL||Full Range|Median
2844485|NCT00124657|Secondary|Erlotinib Tmax|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.|||hours||Full Range|Median
2844486|NCT00124657|Secondary|Cmax of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.|||mg/mL||Full Range|Median
2844487|NCT00124657|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.|During the first 8 weeks of therapy|23 participants were enrolled on Phase I component; 22 were analyzed for DLT over 4 dose levels. 1 treated at dose level 120mg/m^2 was not assessable for DLT due to early tumor progression. 4 were treated before and 19 after the study was amended to exclude grade 3 and 4 electrolyte abnormalities that resolved to ≤ grade 2 within 7 days.|||participants|||Number
2844488|NCT00124618|Secondary|Tumor Response (Complete and Partial)|A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration||||participants|||Number
2844489|NCT00124618|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|From Baseline to up to 3 years||||months||95% Confidence Interval|Median
2844491|NCT00124618|Primary|11-month Survival Rate|"Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with success, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months."|From baseline to 11 months.|This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an NCCTG audit. This analysis includes all 57 patients. Forty of 57 patients (70%) reached the 11-month survival primary point.|||percentage of participants|||Number
2844492|NCT00124579|Secondary|Progression-Free Survival|From date of initial registration to date of progression/relapse of disease (> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years|about 12-18 months|With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.|||Months||95% Confidence Interval|Median
2844493|NCT00124579|Primary|Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).|"Responses are defined as follows:~Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.~Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein < 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.~Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level."|1 year|Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.|||percentage of participants|||Number
2844494|NCT00124579|Secondary|Toxicity Evaluation|To evaluate the qualitative and quantitative toxicities associated with this regimen.|From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years|All participants receiving at least one dose of induction therapy|||Participants|||Number
2844495|NCT00124462|Primary|Change in WOMAC Function Scale (Most Symptomatic Treated Knee)|The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.|Baseline and 12 weeks||||units on a scale change from baseline||Standard Deviation|Mean
2844496|NCT00124462|Primary|Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee)|The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.|Baseline and 12 weeks||||units on a scale change from baseline||Standard Deviation|Mean
2844497|NCT00124449|Secondary|Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies|Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.|Up to 12 months||||participants|||Number
2844498|NCT00124449|Secondary|Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths|AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely|Throughout the treatment period (6 months)|All subjects who received at least 1 dose of study medication|||Participants|||Number
2844499|NCT00124449|Secondary|Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response|This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).|||Participants|||Number
2844500|NCT00124449|Secondary|Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)|The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).|||Participants|||Number
2844501|NCT00124449|Secondary|DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline|The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).|||units on a scale||Standard Error|Mean
2844502|NCT00124449|Secondary|Frequency of Human Leukocyte Antigen (HLA) Typing|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).|Day 1|All randomized and treated participants|||participants|||Number
2844503|NCT00124449|Secondary|Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive|Day 1, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with measure at timepoint).|||Participants|||Number
2844504|NCT00124449|Secondary|Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months|To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.|Baseline, 6 Months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements).|||laboratory values||Standard Error|Mean
2844505|NCT00124449|Secondary|Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline|SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements)|||units on a scale||Standard Error|Mean
2844506|NCT00124449|Secondary|Number of Participants With Persistent Symptomatic Clinical Synovitis|Synovitis, assessed by clinical signs and symptoms|6, 12, and 24 months|All randomized and treated participants (n=number of participants with assessment at baseline and timepoint)|||Participants|||Number
2844507|NCT00124449|Secondary|Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months|Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.|Baseline, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements). MRIs were done only in participants at European Union sites.|||units on a scale||Standard Error|Mean
2844508|NCT00124449|Secondary|Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months|Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.|Baseline, 6 months, 12 months, 24 months|n=participants with a score at baseline and at timepoint|||units on a scale||Standard Error|Mean
2844509|NCT00124449|Secondary|Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease|Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|12 months, 24 months|n=Randomized and treated participants who were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in the 1- or 2-year window were excluded from the analysis).1 participant in Placebo group was excluded due to the presence of RA at baseline.|||Participants|||Number
2844510|NCT00124449|Secondary|Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|24 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 2-year window were excluded from the analysis). 1 subject in the Placebo group is excluded due to presence of RA at baseline.|||Participants|||Number
2844511|NCT00124449|Primary|Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.|12 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 1-year window were excluded from the analysis). 1 participant in Placebo group was excluded due to presence of RA at baseline.|||Participants|||Number
2844512|NCT00124176|Secondary|Serum Albuterol S Isomer Levels||After 6 hours of continuous albuterol||||ng/mL||Standard Deviation|Mean
2844513|NCT00124176|Secondary|Serum Potassium Levels||After 12 hours of continuous nebulization||||mg/dL||Standard Deviation|Mean
2844514|NCT00124176|Secondary|Heart Rate||After 12 hours of continuous nebulization||||beats per minute||Standard Deviation|Mean
2844515|NCT00124176|Secondary|Change in Pediatric Asthma Severity Score|"Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst)~Score at each time point is calculated by adding 3 elements:~Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)"|After 12 hours of continuous nebulization||||units on a scale||Standard Deviation|Mean
2844516|NCT00124176|Primary|Duration of Continuous Therapy|standard intention to treat (ITT) analysis|During hospitalization||||Hours||Inter-Quartile Range|Median
2844517|NCT00124072|Secondary|Total Strokes||6.7 years median follow-up|||||||
2844522|NCT00124072|Primary|Major Vascular Events (MVE)|Major vascular events (MVE) defined as major coronary events (MCE [non-fatal MI, coronary death or coronary revascularisation]), non-fatal or fatal stroke, or peripheral revascularization (peripheral artery angioplasty or arterial surgery, including amputations), during the scheduled study treatment period.|6.7 years median follow-up||||Participants|||Number
2844523|NCT00124020|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)~Failure - at least one of the following:~Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy~Termination of study med due to lack of efficacy~Death on or after Day 3 attributable to primary infection~Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.~Indeterminate: Inability to determine outcome"|7-14 days following end of antibiotic treatment||||participants|||Number
2844524|NCT00123955|Secondary|Left Ventricular Diastolic Stiffness|"Echocardiography Doppler measurement of left ventricular diastolic function:~Early mitral annulus velocity (lateral) (Ea; cm/s)"|Baseline, 4 month and 9 month||||cm/s||Standard Deviation|Mean
2844525|NCT00123955|Secondary|Concentric Left Ventricular Remodeling|"Left ventricle measurements by MRI:~Mass/end diastolic volume ratio: g/ml"|Baseline, 9 month||||g/ml||Standard Deviation|Mean
2844526|NCT00123955|Primary|Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score|"The Minnesota Living with Heart Failure Questionnaire (MLHF) is a self-administered disease-specific questionnaire for patients with Heart Failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.~Scale of 0-105:The higher the score the worse the heart failure related Quality of Life."|Baseline, 4 and 9 months||||units on a scale||Standard Deviation|Mean
2844527|NCT00123955|Primary|Exercise Intolerance|Peak exercise VO2|Baseline, 4 and 9 months|The outcome measure data uses data from all participants with 4 and/or 9 month follow-up. Thirty-seven participants randomized to spironolactone and 35 participants randomized to placebo completed 4 months of follow-up, and 37 participants randomized to spironolactone and 34 participants randomized to placebo completed 9 months of follow-up.|||ml/kg/min||Standard Deviation|Mean
2844528|NCT00123734|Secondary|To Provide Estimates of the Sensitivity and Specificity of [99mTc] ThromboView® for DVT at the 1-hour and 3-hour Imaging Time Points||May 2007|||||||
2844529|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Sensitivity||95% Confidence Interval|Mean
2844530|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
2844531|NCT00123734|Primary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT.||September 2005||||% Sensitivity||95% Confidence Interval|Mean
2844532|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Sensitivity||95% Confidence Interval|Mean
2844533|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
2844534|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded||May 2007|Number of participants with suspected recurrent DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
2844535|NCT00123734|Primary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images|||% Specificity||95% Confidence Interval|Mean
2844536|NCT00123682|Secondary|Self-reported Quit Attempt||6 months||||percentage of participants|||Number
2844537|NCT00123682|Secondary|Use of Cessation Medications||6 months||||percentage of participants|||Number
2844538|NCT00123682|Primary|7-day Point Prevalence Abstinence From Smoking||6 month||||percentage of participants|||Number
2844539|NCT00123643|Primary|Flow Mediated Dilation|Measure of endothelial function|change from baseline to 6 months|All completers were analyzed|||percent change||Standard Deviation|Mean
2844540|NCT00123630|Primary|Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups||16 weeks|The analysis was per protocol. There were no subjects who were withdrawn or lost to follow-up in this study.|||perecentage of eos per high power field|||Number
2844541|NCT00123604|Primary|Flow Mediated Dilation|Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.|change from baseline to 5 months||||percentage of change in dilation||Standard Deviation|Mean
2844542|NCT00123487|Secondary|Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants|A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in msec.|Baseline up to Year 2|All participants who received at least one dose of study drug and had appropriate ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
2844566|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants were summarized.|||percentage of participants||95% Confidence Interval|Number
2844543|NCT00123487|Secondary|Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants|A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).|Baseline to Year 2|All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
2844544|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase (AST) Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. Serum creatinine (H) Gr 3: >3.0 to 6.0*ULN; Gr 4: >6.0*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; Phosphorus (L): Gr 3: <2.0 - 1.0 mg/dL , Gr 4: <1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.|||participants|||Number
2844545|NCT00123487|Secondary|Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: <1.0*10^9/L. ANC: <0.5*10^9/L. Platelet count <25.0 to 10^9/L.|Day 1 up to Year 7|All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
2844546|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Baseline was laboratory value obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Those participants who did not have a parameter reported at baseline are indicated.|||participants|||Number
2844547|NCT00123487|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants|With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.|Day 1 to Year 7|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.|||participants|||Number
2844548|NCT00123487|Secondary|Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population|PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.|24 months, 36 months, 48 months, 60 months|Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.|||percentage of participants||95% Confidence Interval|Number
2844549|NCT00123487|Secondary|Median Overall Survival (OS) - Randomized Population|OS was defined as time from randomization until date of death. Participants who had not died or who were lost to follow-up were censored on the last date on which the participant was known to be alive. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.|||Months||95% Confidence Interval|Median
2844550|NCT00123487|Secondary|Median Progression Free Survival (PFS) - Randomized Population|PFS was defined as: Time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.|||Months||95% Confidence Interval|Median
2844551|NCT00123487|Secondary|Number of Participants With Best Cytogenic Response (CyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.|||participants|||Number
2844552|NCT00123487|Secondary|Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
2844553|NCT00123487|Secondary|Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population|Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and <100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Minor Hematologic Response (MiHR): <15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.|Randomization up to 6 months, 2 years|Participants were analyzed based on the treatment they were randomized to receive.|||participants|||Number
2844554|NCT00123487|Secondary|Percent of Participants With Overall Hematologic Response - Randomized Population|Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. MiHR defined as: < 15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
2844555|NCT00123487|Secondary|Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study|MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Median duration was measured in months.|Day 1 up to 5 years|Participants who achieved a MaHR during the study.|||Months||95% Confidence Interval|Median
2844556|NCT00123487|Secondary|Median Time to Major Hematologic Response (MaHR) - Randomized Population|A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.|Day 1 up to 6 months (time of primary endpoint), 2 years|Participants were analyzed based on the treatment they were randomized to receive.|||Months||95% Confidence Interval|Median
2844557|NCT00123487|Secondary|Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population|MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.|||percentage of participants||95% Confidence Interval|Number
2844565|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months|All randomized participants were summarized.|||percentage of participants||95% Confidence Interval|Number
2844558|NCT00123487|Secondary|Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population|A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive.|||percentage of participants||95% Confidence Interval|Number
2844559|NCT00123487|Primary|Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population|MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.|Randomization up to 6 months|Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.|||percentage of participants||95% Confidence Interval|Number
2844560|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.|Baseline to 30 days post last dose, up to 7 years (study closure July 2014)|All randomized participants who received at least one dose of study drug were summarized.|||participants|||Number
2844561|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.|Baseline to 30 days post last dose, up to 24 months|All randomized participants who received at least one dose of study drug were summarized.|||participants|||Number
2844562|NCT00123474|Secondary|Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.|||percentage of participants||95% Confidence Interval|Number
2844563|NCT00123474|Secondary|Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.|||percentage of participants||95% Confidence Interval|Number
2844564|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.|24 months|All randomized participants were summarized.|||percentage of participants||95% Confidence Interval|Number
2844567|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants with available data were summarized|||percentage of participants||95% Confidence Interval|Number
2844568|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up|A CHR was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-intolerant participants were summarized.|||percentage of participants|||Number
2844569|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose|CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.|6 months, 24 months|All randomized imatinib-intolerant participants with available data were summarized.|||percentage of participants||95% Confidence Interval|Number
2844570|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.|||percentage of participants||95% Confidence Interval|Number
2844571|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.|||percentage of participants||95% Confidence Interval|Number
2844572|NCT00123474|Secondary|Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants|BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).|Baseline up to 24 months|All randomized, treated participants with available mutation data were summarized.|||participants|||Number
2844573|NCT00123474|Secondary|Number of Participants With CHR Whose Disease Progressed by 24 Months|Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.|24 months|All imatinib-resistant participants who achieved CHR and then experienced disease progression were summarized.|||participants|||Number
2844584|NCT00123409|Secondary|Reduced Problems Related to Alcohol|The Short Inventory of Problmes was used to measure the number of alcohol related problems encountered in the prior 3 months. The scale has a minimum of 0 with lower as better. The max score is 15 with each problem rated as present or absent.|12 months||||# of alcohol problems||Standard Deviation|Mean
2844585|NCT00123409|Primary|Reduced Alcohol Use|Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.|12 months||||Days drinking||Standard Deviation|Mean
2844833|NCT00121472|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|baseline to 6 months|Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included.|||meters||Standard Error|Mean
2844574|NCT00123474|Secondary|Number of Participants With MCyR Whose Disease Progressed by 24 Months|Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.|24 months|All imatinib-resistant participants who had achieved MCyR and experienced disease progression were summarized.|||participants|||Number
2844575|NCT00123474|Secondary|Time to CHR in Participants With CHR At 24 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with CHR were summarized.|||Months||95% Confidence Interval|Median
2844576|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 24 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with MCyR were summarized.|||Months||95% Confidence Interval|Median
2844577|NCT00123474|Secondary|Time to CHR in Participants With CHR at 6 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with CHR and available data were summarized.|||Months||95% Confidence Interval|Median
2844578|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 6 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with MCyR and available data were summarized.|||Months||95% Confidence Interval|Median
2844579|NCT00123474|Secondary|Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up|A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-resistant participants with available data were summarized.|||percentage of participants||95% Confidence Interval|Number
2844580|NCT00123474|Secondary|Percent of Participants With MCyR At or Prior to 24 Months Follow-Up|CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|24 months|All randomized imatinib-resistant participants with available data were summarized.|||percentage of Participants||95% Confidence Interval|Number
2844581|NCT00123474|Primary|Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up|Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|6 months|All randomized imatinib-resistant participants with available data were summarized.|||percentage of Participants||95% Confidence Interval|Number
2844582|NCT00123422|Secondary|Inspiratory Capacity|Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.|14 weeks|Intent-to-treat analysis was used so data on all randomized patients were analyzed.|||Liters||Standard Deviation|Mean
2844583|NCT00123422|Primary|Exercise Endurance|Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.|14 weeks|We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.|||minutes||Standard Deviation|Mean
2844586|NCT00123162|Secondary|Improvement in Pain Severity Determined by Visual Analog Scale (VAS).|"The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, no pain and to the right, worst pain I have ever felt. The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain."|Each hour of the study (0, 1, 2, 3, 4).||||mm||Standard Deviation|Mean
2844587|NCT00123162|Primary|The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo.|The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach.|Hours 1, 2, 3 and 4.||||units on a scale||Standard Deviation|Mean
2844588|NCT00123123|Secondary|Clinical Pulmonary Infection Score (CPIS) at 48 Hours|"The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate:~0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome."|48 hours||||units on a scale||Standard Deviation|Mean
2844589|NCT00123123|Primary|Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours|Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.|Every 48 hours until discharge|All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.|||CFU/mL||Standard Deviation|Mean
2844590|NCT00123110|Secondary|Body Mass Index (BMI)||baseline and 12 weeks||||percent change||Standard Deviation|Mean
2844591|NCT00123110|Secondary|Dehydroepiandrosterone Sulfate (DHEA-S)||baseline and 12 weeks||||percent change||Full Range|Median
2844592|NCT00123110|Secondary|Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent||baseline and 12 weeks|Data were not collected and the outcome will never be analyzed.||||||
2844593|NCT00123110|Secondary|Percent Change in Systolic Blood Pressure||baseline and 12 weeks||||percent change||Standard Deviation|Mean
2844594|NCT00123110|Secondary|Percent Change in Low Density Lipoprotein (LDL)||baseline and 12 weeks||||percent change||Standard Deviation|Mean
2844595|NCT00123110|Secondary|Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)|Insulin resistance calculated from homeostasis model assessment of insulin resistance (HOMA-IR) equation: fasting insulin x fasting glucose / 405. Higher values indicate more insulin resistance.|baseline and 12 weeks||||percent change||Standard Deviation|Mean
2844596|NCT00123110|Secondary|Percent Change in Luteinizing Hormone (LH) From Baseline||baseline and 12 weeks||||percent change||Full Range|Median
2844597|NCT00123110|Primary|Change in Insulin Sensitivity|Change in insulin sensitivity (mg/kg/min) calculated from hyperinsulinemic euglycemic clamp|baseline and 12 weeks||||mg/kg/min||Standard Deviation|Mean
2844598|NCT00123110|Primary|Percent Change in Free Testosterone (T)|Percent change in free T by equilibrium dialysis between baseline and 12 weeks|Baseline to 12 weeks||||percent change||Standard Deviation|Mean
2844599|NCT00122980|Secondary|Growth and Development - Weight (Change From Baseline to Endpoint)||baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data|||kg||Standard Deviation|Mean
2844600|NCT00122980|Secondary|Growth and Development - Height (Change From Baseline to Endpoint)||Baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data|||cm||Standard Deviation|Mean
2844601|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)- Verbal Ability|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Higher scores mean better abilities/achievements. Scaled scores range from 0-100.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2844602|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)-Excluding Verbal|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Scaled scores range from 0-100. Higher scores mean better abilities/achievements.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2844603|NCT00122980|Secondary|Barthel Index (Change From Baseline)|The Barthel Index is a measure of activities of daily living (ADL) and assesses the degree of disability in a particular participant. The index records indicators of independence in terms of the disability caused by impairments, such as those that may be sequelae of stroke. The index was used as a record of what the participant did, not as a record of what the participant could do. Barthel scores range from 0 to 100, with higher scores indicating greater independence in daily living activities (caring for oneself).|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
2844604|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Child Report (Change From Baseline)|The PedsQLTM Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, midpoint (week 64), and study exit (up to 30 months of treatment)|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
2844605|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Parent Report (Change From Baseline)|The PedsQL(TM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, mid-point (week 64), and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
2844606|NCT00122980|Primary|Liver Iron Content (LIC) Change-from-baseline|LIC change-from-baseline is the second component of the composite primary endpoint. LIC was measured by quantitative liver biopsy at baseline and at 30 months or exit from the study.LIC values were transformed into Log10 values prior to computing the change from baseline.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|Intent-to-treat AND both baseline and 30-month post-treatment LICs.|||mg ferritin/gram dry weight liver||Standard Deviation|Log Mean
2844607|NCT00122980|Primary|Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period|Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|The Intent-to-Treat population included all subjects who were randomized and who received any on-study treatment.|||participants|||Number
2844608|NCT00122954|Secondary|Quality of Life (SF-36)|SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function.|baseline to 3 months|A total of 8 participants discontinued (placebo n = 2, 1 colitis, 1 swallowing problems; treatment n = 8, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off anti-depressant, 1 travel difficulties) and did not complete measures at end of study|||mean change of units on a scale||Standard Error|Mean
2844609|NCT00122954|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).|baseline to 3 months|A total of 8 participants discontinued intervention (placebo n = 2, 1 colitis and 1 swallowing problems; treatment n = 6, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off antidepressant, 1 travel issues) and did not complete outcome measures|||percentage of subjects|||Number
2844610|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
2844611|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2844612|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
2844613|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2844614|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
2846929|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population|Measured by DXA.|Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2844615|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2844616|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||Participants|||Count of Participants
2844617|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection|GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.|At Month 7|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2844618|NCT00122681|Secondary|Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|Titers were expressed as GMTs.|At month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
2844619|NCT00122681|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|"Seropositivity was defined as subjects with a titer equal to or greater than 40.~Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination."|At Month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity which included subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2844620|NCT00122681|Secondary|HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)|Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).|Month 0, 7, 12, 24|The analyses was performed on the Total Vaccinated cohort on subjects with available results.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2844621|NCT00122681|Secondary|HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)|"HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.~HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL."|Month 0, 7, 12 and 24|Analyses was performed on the Total Vaccinated Cohort on subjects with available results.|||Participants|||Count of Participants
2844622|NCT00122681|Secondary|Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset|"Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).~GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)]."|At Months 6, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2844623|NCT00122681|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus|"Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)"|At Months 6, 7, 12, 24, 36 & 48|The analyses were performed on the ATP cohort for immunogenicity on evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
2844624|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2844625|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2844626|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2844627|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2844628|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12.|||Participants|||Count of Participants
2844629|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12|||Participants|||Count of Participants
2844630|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2844631|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.~HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.|||Participants|||Count of Participants
2844632|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.~HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.|||Participants|||Count of Participants
2844650|NCT00122460|Secondary|Best Overall Response|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||percentage of participants||95% Confidence Interval|Number
2844633|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12|||Participants|||Count of Participants
2844634|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12|||Participants|||Count of Participants
2844635|NCT00122681|Secondary|Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus|Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||subjects|||Number
2844636|NCT00122681|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||Participants|||Count of Participants
2844637|NCT00122681|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study (Month 0 to 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||Participants|||Count of Participants
2844638|NCT00122681|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort. The data are presented stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus (by ELISA).|||Participants|||Count of Participants
2844639|NCT00122681|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Safety Subset of the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.|||Participants|||Count of Participants
2844640|NCT00122681|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria.~Data are presented across the 3 doses."|Within 7 days after any vaccination|Analysis was performed on a safety subset of the Total vaccinated cohort, which included vaccinated subjects from certain sites. Data are presented for the total subset (total), then stratified subject HPV-16/18 DNA & serostatus at baseline: DNA positive (DNA+) or negative (DNA-), ELISA seropositive (sero+) or seronegative (sero-).|||Participants|||Count of Participants
2844641|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.|||Participants|||Count of Participants
2848319|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
2844642|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.|||Participants|||Count of Participants
2844643|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.|||Participants|||Count of Participants
2844644|NCT00122460|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007|Safety population|||participants|||Number
2844645|NCT00122460|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23|||scores on a scale||Standard Error|Least Squares Mean
2844646|NCT00122460|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22|||scores on a scale||Standard Error|Least Squares Mean
2844647|NCT00122460|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||months||95% Confidence Interval|Median
2844648|NCT00122460|Secondary|Time to Treatment Failure|"Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment."|Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||months||95% Confidence Interval|Median
2844649|NCT00122460|Secondary|Disease Control|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||percentage of participants||95% Confidence Interval|Number
2844694|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|0 min|Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point).|||units on a scale||Inter-Quartile Range|Median
2844651|NCT00122460|Secondary|Progression-free Survival Time (PFS)|"Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.|||months||95% Confidence Interval|Median
2844652|NCT00122460|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|"Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized).~Analysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007."|||months||95% Confidence Interval|Median
2844653|NCT00122447|Other Pre-specified|AIM 2: Difference in FMD (Measure of Endothelial Function)|"Comparison of FMD (measure of endothelial function) between NGT, IGT and diabetes at baseline. FMD is a surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression.~No analysis was conducted due to under-recruitment."|Cross-sectional|||||||
2844654|NCT00122447|Primary|AIM 1: Change in Flow Mediated Dilation (FMD) (%)|Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing|||percentage of arterial dilation change||Standard Deviation|Mean
2844655|NCT00122447|Secondary|AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level|Inflammatory marker|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing|||mg/L||Standard Error|Mean
2844656|NCT00122382|Secondary|Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period|Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated in the DB period. n=Number of participants evaluated for this measure.|||participants|||Number
2844657|NCT00122382|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated participants in the Double-Blind period|||participants|||Number
2844658|NCT00122382|Secondary|Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)|Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12, Month 24|Analysis includes all treated participants in the open-label period originally randomized to abatacept. Analysis includes all participants with observed assessments collected at Baseline (Day 1), Day 365 (Month 12), and Day 729 (Month 24)|||units on a scale||Standard Error|Mean
2844659|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12|Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Month 12, Month 24|Number of Participants Analyzed=All treated participants in the open-label period. (Treatment groups represent treatment received in the double-blind period.) n=the number of subjects with observed data included in the analysis.|||Participants|||Number
2844660|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24|Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 24|All treated participants in the open-label period. Treatment groups represent treatment received in the double-blind period.|||Participants|||Number
2844767|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
2844661|NCT00122382|Primary|Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL|Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All participants treated during the open-label period; n= number of participants evaluated for this measure.|||participants|||Number
2844662|NCT00122382|Primary|Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All Treated participants in the Open-label Period; n=number of participants evaluated for this measure.|||participants|||Number
2844663|NCT00122382|Primary|Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period|There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.|Open-Label Period (Month 12 to Month 24)|All participants treated during the Open-Label period.|||Participants|||Number
2844664|NCT00122382|Primary|Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants|The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.|||number of patients/100 patient-years|||Number
2844665|NCT00122382|Primary|Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants|The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.|||Number of patients/100 patient-years|||Number
2844666|NCT00122382|Primary|Incidence Rates of Autoimmune Disorders in ABA-Treated Participants|The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.|||Number of participants/100 patient-years|||Number
2844667|NCT00122382|Primary|Number of Participants With SAEs With an Outcome of Death During the Open-label Period|Any untoward medical occurrence (SAE) that resulted in death|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.|||participants|||Number
2844668|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.|Baseline, Month 24|All treated participants in the open-label period. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied. Treatment groups represent treatment received in the double-blind period.|||units on a scale||Standard Deviation|Mean
2844669|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Baseline, Month 24|All treated participants in the Open-label period. Treatment groups represent treatment received in the Double Blind Period.|||participants|||Number
2844768|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^9 c/L||Standard Error|Mean
2844670|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|Treated participants in the open-label period were evaluated for anti-abatacept or anti-CTLA4-T responses|||participants|||Number
2844671|NCT00122382|Primary|Number of Participants With Serious Adverse Events Reported During the Open-Label Period|SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.|||participants|||Number
2844672|NCT00122382|Primary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.|||participants|||Number
2844673|NCT00122382|Primary|Mean Change From Baseline in Radiographic Total Score to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12|The analysis was intent-to-treat. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied.|||units on a scale||Standard Deviation|Mean
2844674|NCT00122382|Primary|Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12|Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.|Month 12|Intent to treat = all randomized and treated subjects. Those with missing data post-discontinuation were considered non-responders.|||participants|||Number
2844675|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.|Treated participants in the double-blind period who were evaluated for anti-abatacept or anti-CTLA4-T responses|||Participants|||Number
2844676|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value|Baseline, Month 12|Intention-to-Treat - linear extrapolation imputation. Analysis of change from baseline restricts subjects included in to the analysis to those with baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2844677|NCT00122382|Secondary|Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12|The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.|||units on a scale||Standard Error|Mean
2844769|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^6 c/µL||Standard Error|Mean
2844678|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.|||participants|||Number
2844679|NCT00122382|Secondary|Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12|DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.|||units in a scale||Standard Error|Mean
2844680|NCT00122382|Secondary|Number of Participants With Major Clinical Response (MCR) at Month 12|MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.|||participants|||Number
2844681|NCT00122382|Secondary|Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12|ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.|||participants|||Number
2844682|NCT00122369|Primary|Time Trends of Pain Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy|||logit slopes|||Number
2844683|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|110 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844684|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|100 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844685|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|90 min|Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point).|||units on a scale||Inter-Quartile Range|Median
2844686|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|80 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844687|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|70 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844688|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|60 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844689|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|50 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844690|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|40 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844691|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|30 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844692|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|20 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844693|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|10 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844695|NCT00122369|Primary|Time Trends of Anxiety Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy|||logit slopes|||Number
2844696|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|110 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844697|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|100 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844698|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|90 min|Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point)|||units on a scale||Inter-Quartile Range|Median
2844699|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|80 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844700|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|70 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844701|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|60 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844702|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|50 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844703|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|40 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844704|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|30 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844705|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|20 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844706|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|10 min|Patients remaining on procedure table|||units on a scale||Inter-Quartile Range|Median
2844707|NCT00122369|Secondary|Impact of Event Scale (IES-15)|"The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75.~≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy"|Patients were followed for up to 3 weeks after their biopsy until the time of their surgery|These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.|||Scores on a Scale||Standard Deviation|Mean
2844708|NCT00122369|Secondary|Salivary Cortisol Secretion|Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.|Patients were followed for the 5 days following their breast biopsy|Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the “known malignant” group, 37 in the “known benign” group, and 73 in the “uncertain group” totaling 126 patients.|||ln (microgram/dL)/hr||95% Confidence Interval|Mean
2844709|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.|0 min|Intention to Treat; patients on procedure table|||units on a scale||Inter-Quartile Range|Median
2844710|NCT00122317|Secondary|Incidence of Thrombosis After Eculizumab Infusion|Thrombosis was defined as occurrence of major adverse vascular events|From time of first ever dose through last dose (up to 24 months of study treatment)||||Number of events per 100 patient-years|||Number
2844770|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||percentage red blood cells||Standard Error|Mean
2844711|NCT00122317|Secondary|Quality of Life as Measured by FACIT-Fatigue Scale Change From Baseline|The FACIT-Fatigue scale is a collection of quality of life questionnaires pertaining to the management of fatigue symptoms due to a chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Patients score each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher score indicating better quality of life.|From time of first infusion through 24 months of study treatment||||units on a scale||Standard Deviation|Mean
2844712|NCT00122317|Secondary|Hemolysis as Measured by Change From Baseline in LDH Area Under the Curve||From time of first infusion through 24 months of study treatment||||U/L x Day||Standard Deviation|Mean
2844713|NCT00122317|Primary|Incidence of Treatment-emergent Adverse Events||From time of consent to a maximum of 2.5 years of study treatment||||Participants|||Count of Participants
2844714|NCT00122278|Secondary|Functional Disability at 24 Hours|No functional impairment within 24 hours of emergency department discharge|24 hours||||Participants|||Count of Participants
2844715|NCT00122278|Primary|Persistent Headache Pain Free at 24 Hours|Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge|24 hours||||Participants|||Count of Participants
2844716|NCT00122187|Primary|Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results|Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis|||percent patients with GI consult+workup|||Number
2844717|NCT00122187|Primary|Percent of Patients Receiving GI Consult for FOBT+ Results|Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis|||percent patients receiving GI consult|||Number
2844718|NCT00122135|Primary|Presence of Discussions About End of Life Care Goals/Wishes|Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes|immediate||||participants|||Number
2844719|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Post-treatment (2 weeks following last treatment session)||||units on a scale||Standard Deviation|Mean
2844720|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|6-Month Follow Up||||units on a scale||Standard Deviation|Mean
2844721|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|3-Month Follow Up||||units on a scale||Standard Deviation|Mean
2844722|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Post-treatment (2 weeks following last treatment session)||||units on a scale||Standard Deviation|Mean
2844723|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
2844724|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|6-month Follow Up||||units on a scale||Standard Deviation|Mean
2844725|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|3-month Follow Up||||units on a scale||Standard Deviation|Mean
2844726|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Baseline||||units on a scale||Standard Deviation|Mean
2844727|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Post-treatment (2 weeks following last treatment session)||||units on a scale||Standard Deviation|Mean
2844771|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||g/dL||Standard Error|Mean
2844728|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Index|Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Baseline||||units on a scale||Standard Deviation|Mean
2844729|NCT00121836|Secondary|Number of Participants With Marked Laboratory Abnormalities|The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.|until progressive disease or for up to 3 years|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Participants|||Number
2844730|NCT00121836|Secondary|Premature Withdrawal From Study Due to Adverse Events|The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Participants|||Number
2844731|NCT00121836|Secondary|Number of Subjects With Adverse Events|"The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution."|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Participants|||Number
2844732|NCT00121836|Primary|Overall Survival|Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death|approximately 505 days (Median Time to Death)|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.|||Days||95% Confidence Interval|Median
2844733|NCT00121810|Secondary|Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)|"Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.|||percent change||Standard Deviation|Mean
2844734|NCT00121810|Secondary|Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization"|baseline 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.|||percent change||Standard Deviation|Mean
2844735|NCT00121810|Secondary|Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.|||percent change||Standard Deviation|Mean
2844736|NCT00121810|Secondary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24|"A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.~percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|Baseline to 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.|||percent change||Standard Deviation|Mean
2845375|NCT00116779|Secondary|Median Di-Hydrotestosterone Levels At Various Study Timepoints|Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14|Baseline, Days 1, 3, 7, 14|ITT population|||picogram / milliliter||Full Range|Median
2844737|NCT00121810|Primary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12|"The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.~percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|baseline to 12 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.|||percent change||Standard Deviation|Mean
2844738|NCT00121719|Other Pre-specified|Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples|Based on the data in assay development stage before PD biomarker analysis in study E7080-E044-101 we did not find the appropriate PD biomarker in PBMC, therefore we did not have any biomarker analysis for PK/PD analysis.|Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatment|No appropriate PD biomarker in PBMC, therefore we did not have any biomarker analysis for PK/PD analysis.||||||
2844739|NCT00121719|Secondary|Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib||Cycle 1 Day 15 and Day 22: 0-24 hours postdose (Cycle length = 28 days)|The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.|||Hours||Full Range|Median
2844740|NCT00121719|Secondary|Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib||Cycle 1 Day 15 and Day 22: 0-24 hours postdose (Cycle length = 28 days)|The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.|||ng/mL||Standard Deviation|Mean
2844741|NCT00121719|Secondary|Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))||Cycle 1 Day 15 and Day 22: 0-24 hours postdose (Cycle length = 28 days)|The Food Effect Population consisted of all participants who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.|||ng*hr/mL||Standard Deviation|Mean
2844742|NCT00121719|Secondary|Renal Clearance (CLr) of Lenvatinib||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||L/hour||Standard Deviation|Mean
2844743|NCT00121719|Secondary|Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||Percentage of lenvatinib||Standard Deviation|Mean
2844744|NCT00121719|Secondary|Apparent Volume of Distribution (Vz/F)||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||Liter (L)||Standard Deviation|Mean
2844745|NCT00121719|Secondary|Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||Liter per hour (L/hr)||Standard Deviation|Mean
2844746|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||ng*hr/mL||Standard Deviation|Mean
2844747|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2844748|NCT00121719|Secondary|Apparent Plasma Half-life (t1/2) of Lenvatinib||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||Hours||Standard Deviation|Mean
2844749|NCT00121719|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenvatinib||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|PK population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||Hours||Standard Deviation|Mean
2844750|NCT00121719|Secondary|Maximum Plasma Concentration (Cmax) of Lenvatinib||Cycles 1 and 2 Day 1: 0-24 hours postdose (Cycle length = 28 days)|Pharmacokinetic (PK) population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle. The PK analysis set where data at specified timepoints was available.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2844751|NCT00121719|Secondary|Best Overall Response (BOR)|BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at 7 weeks or later after starting lenvatinib.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years|ITT population included all participants who received at least one dose of lenvatinib.|||Percentage of participants|||Number
2844752|NCT00121719|Secondary|Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%|Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.|First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 13 years and 8 months|Safety population (ITT population) included all participants who took at least one dose of lenvatinib.|||Percentage of participants|||Number
2844753|NCT00121719|Secondary|Dose-limiting Toxicities (DLTs)|A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.|Cycle 1 (4 weeks) of each dose level|ITT/ safety population included all participants who received at least one dose of lenvatinib.|||Participants|||Number
2844754|NCT00121719|Secondary|Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)|All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. Treatment-related AEs and SAEs are AEs considered probably or possibly related to lenvatinib.|First date of study treatment to date of last dose of study treatment, up to approximately 13 years and 8 months|Safety population (ITT population) included all participants who received at least one dose of lenvatinib.|||Percentage of participants|||Number
2844755|NCT00121719|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.|Cycle 1 (4 weeks)|ITT population included all participants who received at least one dose of lenvatinib.|||milligram (mg)|||Number
2844756|NCT00121667|Other Pre-specified|Confirmed Hypoglycemia During the ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants|||participants|||Number
2844757|NCT00121667|Other Pre-specified|All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants|||participants|||Number
2844758|NCT00121667|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206,|Number of Participants Analyzed=Treated Participants; BL n=normal or abnormal ECG status at baseline of the cohort of participants with measure at given time point|||participants|||Number
2844759|NCT00121667|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||beats/min||Standard Error|Mean
2844760|NCT00121667|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
2844761|NCT00121667|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
2844762|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
2844763|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
2844764|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
2844765|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
2844766|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||10^3 c/µL||Standard Error|Mean
2844772|NCT00121667|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period|||participants|||Number
2844773|NCT00121667|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|All treated participants|||participants|||Number
2844774|NCT00121667|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).|||mg*min/dL||Standard Error|Mean
2844775|NCT00121667|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2844776|NCT00121667|Secondary|Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).|||mg/dL||Standard Error|Mean
2844777|NCT00121667|Primary|Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24)|||percentage of glycosylated hemoglobins||Standard Error|Mean
2844778|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point|||beats per minute||Standard Error|Mean
2844779|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
2844780|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
2844781|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline|||participants|||Number
2844782|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants|||participants|||Number
2844783|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants|||participants|||Number
2844784|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants|||participants|||Number
2844785|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants|||participants|||Number
2844818|NCT00121485|Secondary|Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)|The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
2844786|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period|||participants|||Number
2844787|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|All treated participants|||participants|||Number
2844788|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline|||participants|||Number
2844789|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||beats per minute||Standard Error|Mean
2844790|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
2844791|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||mmHg||Standard Error|Mean
2844792|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
2844793|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
2844794|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
2844795|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
2844796|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
2844797|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^3 c/µL||Standard Error|Mean
2844798|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^9 c/L||Standard Error|Mean
2844799|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||x 10^6 c/µL||Standard Error|Mean
2844800|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||percentage red blood cells||Standard Error|Mean
2844801|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point|||g/dL||Standard Error|Mean
2844901|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months||||participants|||Number
2844802|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period|||participants|||Number
2844803|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|All treated participants|||participants|||Number
2844804|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||kg/m^2||Standard Deviation|Mean
2844805|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||kg||Standard Deviation|Mean
2844806|NCT00121641|Other Pre-specified|Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||participants|||Number
2844807|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline||||years||Standard Deviation|Mean
2844808|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort||Baseline, Week 24|Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF).|||mg*min/dL||Standard Error|Mean
2844809|NCT00121641|Primary|A1C Changes From Baseline at Week 24 - Open Label Cohort|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Open-label participants with both a baseline and a post-baseline (up to Week 24)|||Percentage of glycosylated hemoglobins||Standard Error|Mean
2844810|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort||Week 24|Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2844811|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort||Baseline, Week 24|Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF)|||mg/dL||Standard Error|Mean
2844812|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).|||mg*min/dL||Standard Error|Mean
2844813|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
2844814|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).|||mg/dL||Standard Error|Mean
2844815|NCT00121641|Primary|Hemoglobin A1c (A1C) Changes From Baseline at Week 24|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24).|||Percentage of glycosylated hemoglobins||Standard Error|Mean
2844816|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making B|This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||Units measured in seconds||Full Range|Median
2844817|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making A|This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||Units measured in seconds||Full Range|Median
2844819|NCT00121485|Secondary|Neurocognitive Assessments, Boston Naming Test|Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
2844820|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)|The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
2844821|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)|The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
2844822|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)|The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
2844823|NCT00121485|Secondary|Neurocognitive Assessments, Clock Drawing|Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.|||units on a scale||Full Range|Median
2844824|NCT00121485|Secondary|Reoperations|The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons|Patients were followed until outcome or up to 2 years post-implant, whichever came first||||percentage of participants|||Number
2844825|NCT00121485|Secondary|Functional Status (Patient Activity Score)|Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)|||percentage of participants|||Number
2844826|NCT00121485|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)|||Distance (meters)||Standard Deviation|Mean
2844827|NCT00121485|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|Baseline, Months 1, 6, 12|Primary Study Cohort (As Treated)|||percentage of participants in each class|||Number
2844828|NCT00121485|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)|||Units on a KCCQ score scale||Standard Deviation|Mean
2844829|NCT00121485|Secondary|Minnesota Living With Heart Failure Questionnaire(MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.|Baseline, Months 1,3,6,12|Primary Study Cohort (As Treated)|||Units on a MLWHF Score scale||Standard Deviation|Mean
2844830|NCT00121485|Primary|Composite Endpoint|Survival at two (2) years free of stroke, or reoperation to repair or replace the device|Patients' status at 2 years post-implant|Primary Study Cohort (Intent to Treat)|||percentage of participants||95% Confidence Interval|Number
2844831|NCT00121472|Secondary|Post-transplant Survival|30 day and 1 year post transplant survival|30 days, 1 year|Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival.|||percentage of participants|||Number
2844832|NCT00121472|Secondary|Reoperations|Additional surgery after the initial implant operation|continuous|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).|||Number of Events|||Number
2848320|NCT00094900|Secondary|Mean Change in C-Reactive Protein||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
2844834|NCT00121472|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.|Baseline to 6 months|Patients alive and capable of performing the test at 6 months|||units on a MLWHF Score scale||Standard Error|Mean
2844835|NCT00121472|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|baseline, 1 month, 3 months, 6 months|All patients who survived to interval are included.|||units on NYHA scale||Full Range|Mean
2844836|NCT00121472|Secondary|Kansas City Cardiomyopathy Questionaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.|baseline to 6 months|Patients alive and capable of performing the test at 6 months|||Units on a KCCQ Score scale||Standard Error|Mean
2844837|NCT00121472|Secondary|Clinical Reliability (Malfunctions/Failures)|Confirmed malfunctions/Serious Adverse Events|continuous||||Number of Serious Events|||Number
2844838|NCT00121472|Primary|Survival|Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).|180 days|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).|||participants|||Number
2844839|NCT00121238|Secondary|Mean Time to Progression of Prostate Cancer|Kaplan-Meier estimates of time to progression will be reported.|Up to 5 years|Patients were eligible if they had a histologic or cytologic diagnosis of prostate cancer with no evidence of metastatic disease or local progression on radiologic imaging and had 3 consecutive rising levels of prostate specific antigen (psa). Eligible patients who were treated on this trial were analyzed for survival|||months||95% Confidence Interval|Mean
2844840|NCT00121238|Secondary|Median Survival Time|6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.|Up to 5 years||||months||95% Confidence Interval|Median
2844841|NCT00121238|Secondary|The Number of Participants With at Least One Incident of Toxicity|Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.|Up to 5 years|All treated patients, including 2 patients who were deemed ineligible for the study's endpoints to measure efficacy.|||participants|||Number
2844842|NCT00121238|Secondary|Median PSA Slope Difference|Median PSA slope difference was calculated between baseline and 6 months.|Baseline to 6 months||||ng/mL/month||Inter-Quartile Range|Median
2844843|NCT00121238|Primary|The Number of Patients With a PSA Decline of ≥50%|"To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.~This measure defined as a drop in PSA of at least 50% from the final pre-treatment value."|Up to 5 years|Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements.|||participants|||Number
2844844|NCT00121225|Secondary|Comparison of VEGF Serum Levels to Response to Vorinostat|Blood specimens were collected from participants on Day 1 Cycle 1 prior to treatment (baseline), Day 1 3-4 hours following Vorinostat ingestion, Day 8 and Day 15. VEGF serum concentrations were detected using the Luminex multiplexed assay, where the median fluorescence intensity results were analyzed by a weighted five-parameter logistic method. The values were averaged across all time points per participant.|Baseline, Day 1, Day 8 and Day 15||||pg||Standard Deviation|Mean
2844845|NCT00121225|Secondary|Number of Patients With p53 Allelic Variations (72R or 72P)|Participants were assessed for p53 allelic variation at baseline|Baseline|Participant 32 had a pre-treatment punch biopsy that was not adequate for testing|||participants|||Number
2844846|NCT00121225|Secondary|Difference in HP1 and MacroH2A Nuclear Foci Expression Between Progressive Minus Stable Disease Outcomes|Macro H2A and HP1 expression levels were compared through analysis of log fold changes in antibody expression in a multivariate general linear model between progressive disease and stable disease outcomes.|Baseline and day 15|Patient 32 had pre-treatment punch biopsy that was inadequate for testing, thus was not included in this measurement|||log fold change||Standard Error|Mean
2844847|NCT00121225|Secondary|Time to Progression Assessed by RECIST||Up to 5 years||||months||95% Confidence Interval|Median
2844848|NCT00121225|Primary|Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)|Per Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0) for target lesions and are assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in sum of longest diameter of target lesions; Objective Response (OR) = CR+ PR.|Up to 5 years||||participants|||Number
2844849|NCT00121199|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2844850|NCT00121199|Primary|Progression-free Survival at 2 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2844851|NCT00121199|Primary|Progression-free Survival at 1 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-1 year|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2844852|NCT00121199|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.|All patients who started treatment were included in the analysis|||participants|||Number
2844853|NCT00121186|Primary|Overall Survival|OS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration||||participants|||Number
2844854|NCT00121186|Primary|Progression-free Survival|PFS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration||||participants|||Number
2844855|NCT00121173|Secondary|Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model|Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model|9 months||||Participants|||Count of Participants
2844856|NCT00121173|Secondary|Number of Participants With Correlated Measures of Immune Response With Clinical Response|Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV|9 months|All participants who received all 3 vaccinations|||Participants|||Count of Participants
2844857|NCT00121173|Secondary|Number of Participants With T-cell Immune Responses in the Blood|Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)|41 weeks|all patients who completed all 3 vaccinations|||Participants|||Count of Participants
2844858|NCT00121173|Secondary|Regression of CIN3 Lesions|Number of participants with absence of CIN3 lesions at week 15|15 weeks|per protocol; participants who had no CIN3 lesions assessed by colposcopy and biopsy(ies) at the week 15 visit|||Participants|||Count of Participants
2844859|NCT00121173|Primary|Efficacy|The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.|for the duration of the study, and whenever possible, for an additional 5 years|per protocol|||Participants|||Count of Participants
2844860|NCT00121173|Primary|Safety and Toxicity|Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.|for the duration of the study, and whenever possible, for an additional 5 years|per protocol|||Participants|||Count of Participants
2844861|NCT00121134|Primary|The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts||1 year||||percentage of participants|||Number
2844862|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844863|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844864|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844865|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844902|NCT00120289|Primary|Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.|Intention-to-treat|||participants|||Number
2844866|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844867|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844868|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.~The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844869|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844870|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844871|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.~The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844872|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844873|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844874|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844875|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2844876|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 52 weeks||||units on a scale||Standard Deviation|Mean
2844877|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 28 weeks||||units on a scale||Standard Deviation|Mean
2845000|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|24 months posttransplant|intent-to-treat population|||Mean percent change in GFR (mL/min)||Standard Deviation|Mean
2844878|NCT00120627|Post-Hoc|Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text Revision|Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment||||units on a scale||Standard Deviation|Mean
2844879|NCT00120627|Post-Hoc|Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text Revision|Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.|Pre-treatment and Post-treatment||||units on a scale||Standard Deviation|Mean
2844880|NCT00120627|Post-Hoc|Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text Revision|Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment||||units on a scale||Standard Deviation|Mean
2844881|NCT00120627|Secondary|Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization|The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.|Pre-treatment and Post-treatment||||units on a scale||Standard Deviation|Mean
2844882|NCT00120627|Primary|PTST Checklist (PCL) Civilian Version|"The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0=not at all to 5=extremely. Higher scores indicate greater severity and scores range from 17-85."|Pre-treatment and Post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
2844883|NCT00120627|Secondary|Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities|Quality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing data, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
2844884|NCT00120627|Secondary|Mindfulness Attention Awareness Scale (MAAS)|The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.|Baseline, Post-Intervention||||units on a scale||Standard Deviation|Mean
2844885|NCT00120627|Secondary|Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]|"FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of feeling peaceful, having meaning and purpose in life and finding comfort in faith or spiritual beliefs. Items are rated on a 5-point Likert scale: 0 = not at all and 4 = very much. Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being."|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
2844886|NCT00120627|Secondary|Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)|"Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include feeling calm and peaceful, having alot of energy, feeling downhearted and blue -- all rated on a frequency scale from 1= all of the time to 6=none of the time. Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) accomplishing less than you like and (2) not doing work or activies as carefully as usual (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing values; a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
2845041|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
2844887|NCT00120627|Primary|Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR|"The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0=never to 4=daily or almost everyday. The items for intensity are rated from 0=none to 4=extreme. Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis.~The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|||units on a scale||Standard Deviation|Mean
2844888|NCT00120523|Secondary|Vital Signs and Physical Examinations: Pulse|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.|||bpm||Standard Deviation|Mean
2844889|NCT00120523|Primary|Potential Effect on the Developing Immune System|number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.|throughout the 5-year study|Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).|||% of patients with positive ab titer|||Number
2844890|NCT00120523|Secondary|Vital Signs and Physical Examinations: Blood Pressure (BP)|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.|||mmHg||Standard Deviation|Mean
2844891|NCT00120523|Secondary|Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)|"PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.~For the purposes of data presentation, a Not True response was coded a value of zero and a True a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2844892|NCT00120523|Secondary|Body Surface Area Involved With Atopic Dermatitis|TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.|||percentage of TBSA affected||Standard Deviation|Mean
2844893|NCT00120523|Secondary|Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate|"IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.~Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.|||percentage of participants||95% Confidence Interval|Number
2844894|NCT00120523|Primary|Growth Velocity (Weight)||throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.|||kg||Standard Deviation|Mean
2844895|NCT00120523|Primary|Growth Velocity (Height)||throughout the 5-year study|Safety/intent-to-treat (ITT) – all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.|||cm||Standard Deviation|Mean
2844896|NCT00120523|Primary|Safety Assessed by Adverse Events|crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period|throughout the 5-year study|complete safety/ITT population of experimental and control|||percentage of participants|||Number
2844897|NCT00120406|Primary|Primary Patency|Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.|12 months||||Percentage of participants|Participants||Number
2844898|NCT00120406|Primary|Event-free Survival Rate|"Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.~Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted."|12 months||||Percentage of participants|||Number
2844899|NCT00120289|Secondary|Cardiovascular Mortality||Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months.|Intention to treat|||participants|||Number
2844900|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months|Intention to treat|||participants|||Number
2845485|NCT00115765|Secondary|Objective Tumor Response Rate (Irinotecan)|Best overall response of complete or partial response within irinotecan stratum|Overall Study|Intention-to-Treat|||Participant|||Number
2844903|NCT00120250|Secondary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is a highly detailed measure of the presence and severity of the DSM-IV PTSD criteria. The severity score was calculated by adding up the frequency score (scale 0 = none of the time to 4 = most or all of the time) and an intensity score (scale 0 = none to 4 = extreme), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology. In this case, the total score for all 17 symptom questions, which is also the sum of the three symptom clusters, is used."|Week 3||||units on a scale||Standard Deviation|Mean
2844904|NCT00120250|Secondary|Total Sleep Time|Total Sleep Time was derived from a subject-completed daily sleep diary.|8 weeks||||Minutes||Standard Deviation|Mean
2844905|NCT00120250|Secondary|Sleep Latency|Sleep Latency was derived from a subject-completed daily sleep diary.|8 weeks||||Minutes||Standard Deviation|Mean
2844906|NCT00120250|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.|8 weeks||||units on a scale||Standard Deviation|Mean
2844907|NCT00120250|Primary|Short PTSD Rating Interview (SPRINT)|The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.|8 weeks||||units on a scale||Standard Deviation|Mean
2844908|NCT00120042|Secondary|Endometrial Appearances Postpartum||3 years|||||||
2844909|NCT00120042|Secondary|Post-Delivery Blood Loss|Blood loss was assessed by weighing of pads and sheets in addition to clot|3 years||||mls||Inter-Quartile Range|Median
2844910|NCT00120042|Primary|Placental Retention Rate|If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.|3 years||||participants|||Number
2844911|NCT00119847|Secondary|Filtered QRS Duration|Signal-averaged ECG|Baseline and one year||||Milliseconds||Standard Deviation|Mean
2844912|NCT00119847|Secondary|T-wave Variability|Variability in T wave morphology, change between baseline and one year|Baseline and one year||||Microvolts||Standard Deviation|Mean
2844913|NCT00119847|Primary|Short-termed Fractal Scaling Exponent (Alpha 1)|Nonlinear measurement of heart rate variability, change between baseline and 1 year is the primary outcome.|Baseline, one year||||unit-less||Standard Deviation|Mean
2844914|NCT00119678|Secondary|OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept.|After the first dose of open-label period|Immunogenicity analysis population: participants who received abatacept and for whom baseline and at least one additional measurement during the open-label period were available.|||participants|||Number
2844915|NCT00119678|Secondary|OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent|Total exposure to glucocorticosteroid was measured by the total prednisone or prednisone equivalent AUC. Based on the recommendation of the Data Monitoring Committee, the open-label, long-term extension period was terminated by the sponsor, for failure to meet the primary outcome measure for the double-blind period and because of an increase in SAEs in the abatacept treatment group. As such, these data were not analyzed.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
2844916|NCT00119678|Secondary|OL; Total Number of BILAG A Flares Each Participant Experienced|Total number of BILAG A flares in any organ system after steroid tapering = new BILAG A features in any organ system. Scores defined as follows: None: participants with no BILAG A flare; 1: participants with 1 BILAG A flare or participants who discontinued without a new BILAG A flare were imputed as having one event. 2: participants with 2 BILAG A flares; 3 or >3: participants with 3 or more BILAG A flares.Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
2844917|NCT00119678|Secondary|OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline|SLICC/ACR damage index:measure of cumulative damage due to SLE.Damage=non-reversible change occurring since onset of lupus,ascertained by clinical assessment & present for =>6 months.Scores of SLICC/ACR index:1:single episode;2:repeated episodes at least 6 months apart.Change in score from baseline to 1 year presented as:no change,increase 1 (an increase in score of 1),increase >1 (an increase in score of >1).Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365) and on Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
2844918|NCT00119678|Secondary|OL; Number of Participants With a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious lupus features;B:more moderate features;C:mild symptomatic features;D:prior activity with no current symptoms due to active lupus;E:an organ that has never been involved.BILAG scores based on degrees of change in clinical features (1=improving,2=staying the same,3=worsening,4=new).New SLE flare means new BILAG A/B features in any organ system.Based on the recommendation of the Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||||||
2844919|NCT00119678|Secondary|DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept.|From Day 1 to Day 365|Participants who received abatacept and for whom baseline and at least one additional measurement during double-blind period were available.|||participants|||Number
2844920|NCT00119678|Primary|OL; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: all treated participants who entered the OL period and received at least 1 dose of study medication. Where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high(GFR) values and presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844921|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for either low (cholesterol, triglycerides) or high (albumin) has been presented as 0. n = number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844922|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-Rx<LLN, then <0.95x pre-Rx or >ULN. If pre-Rx >ULN, then >1.05x pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9x LLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN; Calcium (total): <0.8xLLN or >1.2xULN (if pre-Rx <LLN, then <0.75x pre-Rx or >ULN. If pre-Rx >ULN, then >1.25x pre-Rx or <LLN.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||participants|||Number
2844923|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for low values (ALP, AST, ALT, GGT, bilirubin, BUN, creatinine) and has been presented as 0."|||participants|||Number
2844924|NCT00119678|Primary|OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for either low(monocytes, basophils, eosinophils) or high(neutrophils) has been presented as 0."|||participants|||Number
2844925|NCT00119678|Primary|OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for high values (hemoglobin, hematocrit, erythrocytes) and has been presented as 0. n = number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844926|NCT00119678|Primary|OL; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||participants|||Number
2844927|NCT00119678|Primary|Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs or SAEs: events with a relationship to the study therapy of certain; probable; possible; or missing.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||participants|||Number
2844928|NCT00119678|Secondary|DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). Significant vital signs and physical examination findings are reported in the AE tables. Symptoms related to lupus were collected in British Isles Lupus Assessment Group (BILAG) assessments."||||||
2844929|NCT00119678|Secondary|DB; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high (GFR) values has been presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844930|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low or high values (albumin, cholesterol, triglycerides) has been presented as 0.n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844931|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)|MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx <LLN, then <0.95* pre-Rx or >ULN. If pre-Rx >ULN, then >1.05* pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9* LLN or >1.1* ULN (if pre-Rx <LLN, then <0.9* pre-Rx or >ULN. If pre-Rx >ULN, then >1.1* pre-Rx or <LLN; Calcium (total): <0.8* LLN or >1.2* ULN (if pre-Rx <LLN, then <0.75* pre-Rx or >ULN. If pre-Rx >ULN, then >1.25* pre-Rx or <LLN.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844932|NCT00119678|Secondary|DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low values (all parameters) and has been presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844940|NCT00119678|Secondary|DB; Number of Participants With a New SLE Flare During the Initial 6 Months|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to 6 months.|All randomized and treated participants, grouped by the treatment randomized to (ITT).|||Participants|||Number
2845073|NCT00118365|Secondary|Biomarker in Adenoma: CEA|carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.|||Adenoma|Participants||Number
2844933|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low(monocytes, basophils and eosinophils) or high values(neutrophils)has been presented as 0.n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844934|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for high values (hemoglobin, hematocrit and erythrocytes)has been presented as 0. n=number of participants with evaluable results (each arm respectively)."|||participants|||Number
2844935|NCT00119678|Secondary|DB; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).Participants grouped for randomized treatments, except where different treatment taken for entire double-blind period (which will instead be presented by first treatment actually received)."|||participants|||Number
2844936|NCT00119678|Secondary|DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs: events with a certain; probable; possible; or missing relationship to the study therapy. Participants who discontinued the study due to an AE were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match."|||participants|||Number
2844937|NCT00119678|Secondary|DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|From start of study drug treatment to Day 365|All randomized and treated participants who were available for analysis, grouped by the treatment randomized to (ITT).|||participants|||Number
2844938|NCT00119678|Secondary|DB; Median Number of Days to the First Occurrence of a New SLE Flare|Elapsed days between start of corticosteroid taper & first day of flare.Scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of corticosteroid taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period|All randomized and treated participants, grouped by the treatment randomized to (ITT).|||Days||95% Confidence Interval|Median
2844939|NCT00119678|Secondary|DB; Total Number of New SLE Flares Each Participant Experienced|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (ITT).|||Participants|||Number
2844963|NCT00119158|Primary|Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.|"Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification.~Total score 0-12"|up to 15 days|Analysis was per protocol, last observation carried forward|||units of a 0-12 scale||Standard Deviation|Mean
2844964|NCT00119041|Primary|A1c|Hemoglobin A1c is a measure of glycemic control|baseline and 18 months||||percentage of Hb that is glycosylated||Full Range|Mean
2844941|NCT00119678|Primary|Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (Intent to Treat [ITT]). Participants who were inception treatment failures were treated as having 1 new flare; participants who discontinued early without any new flares were treated as having 1 new flare.|||Participants|||Number
2844942|NCT00119405|Primary|Mitochondrial Function (mtDNA Levels)|Mitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.|96 weeks||||copies per cell||95% Confidence Interval|Mean
2844943|NCT00119392|Secondary|Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.||At day +84||||Participants|||Count of Participants
2844944|NCT00119392|Secondary|Engraftment and Hematopoietic Toxicity|Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.|At day +100||||days||Full Range|Median
2844945|NCT00119392|Secondary|Response Rates||Up to 8 years||||Participants|||Count of Participants
2844946|NCT00119392|Secondary|Overall and Progression-free Survival|Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.|Up to 8 years||||percent||95% Confidence Interval|Number
2844947|NCT00119392|Primary|Treatment Related Mortality (TRM)|Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.|At day +100||||percent||95% Confidence Interval|Number
2844948|NCT00119379|Secondary|Change in Hip Bone Mineral Density (BMD)|Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||hip BMD, g/cm^2||Inter-Quartile Range|Median
2844949|NCT00119379|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||lumbar spine BMD, g/cm^2||Inter-Quartile Range|Median
2844950|NCT00119379|Secondary|Change in Trunk Fat|Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||trunk fat (kg)||Inter-Quartile Range|Median
2844951|NCT00119379|Secondary|Change in Limb Fat|Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan|Baseline to Week 48||||limb fat (kg)||Inter-Quartile Range|Median
2844952|NCT00119379|Primary|Change in PBMC mtDNA|Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell|Baseline to Week 48||||copies/cell||Inter-Quartile Range|Median
2844953|NCT00119379|Primary|Change in Fat mtDNA Content|Subcutaneous abdominal fat mitochondrial DNA (mtDNA)|Baseline to Week 48||||copies/cell||Inter-Quartile Range|Median
2844954|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment||||percentage of participants||95% Confidence Interval|Number
2844955|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment|Patients who were treated and had baseline and DIC5 LVEF values|||percentage of participants||95% Confidence Interval|Number
2844956|NCT00119262|Primary|Congestive Heart Failure Rate|Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.|assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry|223 treated patients|||percentage of participants||95% Confidence Interval|Number
2844957|NCT00119158|Secondary|Change From Baseline in Patients' Self Assessment of Disease Severity (PSA) of Target Areas|"The patient or caregiver assessment of eczema severity (PSA) was recorded daily in a diary using a 0-4 scale similar to that of the IGA.(0 = clear,~1 = almost clear, 2 = mild disease, 3 = moderate disease,4 = severe disease).~Difference in value of PSA from baseline to end of study"|30 days|||||||
2844958|NCT00119158|Secondary|The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less|"The EASI is a measure of Atopic Dermatitis (AD) severity. A m-EASI score (0-12) was also calculated as the sum of severity (0 = mild to 3 = severe) for four separate AD symptoms: erythema, infiltration ⁄population, excoriation and lichenification.~The percentage of participants whose eczema reaches almost clear"|up to one week|||||||
2844959|NCT00119158|Secondary|The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline)|"The percentage of eczema areas that show improvement in l-IGA score.~The l-IGA were graded on a scale of 0-4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease)."|up to 15 days|||||||
2844960|NCT00119158|Secondary|The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1)|The Investigator Global Assessment (IGA) and l-IGA were graded on a scale of 0-4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe). The percentage of eczema lesions from the total population that reach almost clear|up to 15 days|||||||
2844961|NCT00119158|Secondary|The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less|Time to partial clearance of the localized eczema lesion assessed by the investigator is measured in days|up to one week|||||||
2844962|NCT00119158|Secondary|The Time to Clearance of the Disease|The time to clearance of eczema measured in days|assessed up to 30 days following drug application||||days||Standard Error|Mean
2844965|NCT00119041|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.|Base line and at18 months.|The number subjects was determined on the size of the CBOC.|||units on a scale||Full Range|Mean
2844966|NCT00119015|Secondary|Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
2844967|NCT00119015|Secondary|Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
2844968|NCT00119015|Secondary|Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
2844969|NCT00119015|Secondary|Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
2844970|NCT00119015|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24.~The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks||||units on a scale||Full Range|Median
2844971|NCT00118911|Secondary|Maintenance of Gains in CBT Condition|maintenance of gains in CBT condition for those who responded or partially responded as measured by the ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|12 month follow-up (12 months after baseline assessment)||||units on a scale of symptom severity||Standard Deviation|Mean
2844972|NCT00118911|Primary|Post-treatment ADHD Symptoms|ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|post-treatment (after receiving 12 sessions of treatment)|Analysis was based on intent to treat. We used mixed-effect modeling which automatically imputes data using the slope up to the point of discontinuation.|||units on a scale of symptom severity||Standard Deviation|Mean
2844973|NCT00118898|Secondary|Change in Fasting Triglyceride Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
2844999|NCT00118742|Secondary|Change From Baseline in Creatinine Clearance|Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation|6, 12, and 24 months posttransplantation|intent-to-treat population|||Percent change in creatinine CL (mL/min)||Standard Deviation|Mean
2845505|NCT00115349|Secondary|Initiation of or Increase in Cardiac Medications||continuous|||||||
2845506|NCT00115349|Secondary|Change in Holter Monitor Scores From Baseline to One Year.||one year|||||||
2844974|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Regimen Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||percentage of participants||95% Confidence Interval|Number
2844975|NCT00118898|Other Pre-specified|Number of Participants With Regimen Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||participants|||Number
2844976|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Treatment Modification|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||percentage of participants||95% Confidence Interval|Number
2844977|NCT00118898|Other Pre-specified|Number of Participants With Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||participants|||Number
2844978|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|At week 48 and 96|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.|||percentage of participants||95% Confidence Interval|Number
2844979|NCT00118898|Other Pre-specified|Number of Participants With a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.|||participants|||Number
2844980|NCT00118898|Primary|Time From Treatment Dispensation to Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||Weeks||95% Confidence Interval|Number
2844981|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Virologic Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|At week 48 and 96|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||percentage of participants||95% Confidence Interval|Number
2844982|NCT00118898|Primary|Time From Treatment Dispensation to a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.|||Weeks||95% Confidence Interval|Number
2844983|NCT00118898|Secondary|Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
2844984|NCT00118898|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
2844985|NCT00118898|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||Inter-Quartile Range|Median
2845144|NCT00117962|Primary|18 Month Survival|Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.|18 months (from randomization)||||percentage of participants||95% Confidence Interval|Number
2844986|NCT00118898|Secondary|Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.|"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.~http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm"|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||Participants|||Number
2844987|NCT00118898|Secondary|Number of Participants With Virologic Failure and Emergence of Major Resistance|Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.|||participants|||Number
2844988|NCT00118898|Secondary|Change in CD4 Count (Cells/mm3) From Baseline|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).|At Weeks 48 and 96|Intention to treat: All participants with CD4 data were included, complete-case approach.|||Cells/mm3||Inter-Quartile Range|Median
2844989|NCT00118898|Secondary|Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.|||Participants|||Number
2844990|NCT00118898|Secondary|The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.|||Participants|||Number
2844991|NCT00118898|Secondary|Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.|||Weeks||95% Confidence Interval|Number
2844992|NCT00118898|Other Pre-specified|Number of Participants With Virologic Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||participants|||Number
2844993|NCT00118898|Other Pre-specified|Amount of Study Follow-up|Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.|Follow-up time was variable, median follow-up was 138 weeks|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.|||Weeks||Inter-Quartile Range|Median
2844994|NCT00118898|Primary|Time From Randomization to Virologic Failure|Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.|||Weeks||95% Confidence Interval|Number
2844995|NCT00118755|Secondary|Duration of Overall Clinical Response (CR or PR)|Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.|Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days|Intent-to-treat population|||Days to event||95% Confidence Interval|Median
2844996|NCT00118755|Secondary|Best Overall Clinical Response|"Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered responders), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met."|Through follow-up phase: Approximate Median of 318 days|Intent-to-treat population|||Patients|||Number
2844997|NCT00118755|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, for any cause.|Time to death (through follow-up phase): Approximate Median of 718 days|Intent-to-treat population|||Days||95% Confidence Interval|Median
2844998|NCT00118755|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).|Time to disease progression or death (through follow-up phase)|Intent-to-treat population|||Days||95% Confidence Interval|Median
2845507|NCT00115349|Secondary|Change in ECHO LV Volume, Ejection Fraction, Shortening Fraction, and VCFc/Wall Stress Z-score From Baseline to One Year.||one year|||||||
2845001|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|6 months posttransplant|intent-to-treat population|||Percent change in GFR (mL/min)||Standard Deviation|Mean
2845002|NCT00118742|Primary|Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant|Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|12 months posttransplant|intent-to-treat population|||Percent change in GFR (mL/min)||Standard Deviation|Mean
2845003|NCT00118716|Secondary|Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ)|PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Participants responded to each question on a 7-point scale (7= not bothered at all and 1= extremely bothered). The overall PAQLQ score is the mean of all 23 responses (minimum score 1= 5+8+10/23 and maximum score 7= 35+56+70/23) and the individual domain scores are the means of the items in those domains (minimum: 5/5, 8/8, 10/10 and maximum: 35/5, 56/8, 70/10). Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Endpoint was defined from the last questionnaire collected during the double-blind treatment period or discontinuation visit (up to Week 4).|Baseline (Week 0) and up to Week 4|ITT Population. The PAQLQ was administered only to participants >=7 years old.|||Scores on a scale||Standard Error|Mean
2845004|NCT00118716|Secondary|Percent of Symptom-free Days|A symptom-free day was defined as a day with no symptoms (i.e., a score of 0, indicating no asthma symptoms during the day or previous night, recorded in the daily diary). Percent of symptom-free days was calculated as the number of symptom-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.|Up to Week 4|ITT population. Here, ‘N’ denotes participants with data available at the specified time point.|||Percentage of days||Standard Error|Mean
2845005|NCT00118716|Secondary|Percent of Rescue-free Days|A rescue-free day was defined as a day when no supplemental albuterol was taken (i.e., 0 puffs recorded for both AM and PM assessments of albuterol use in the daily diary). Percent of rescue-free days was calculated as the number of rescue-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.|Up to Week 4|ITT population. Here, ‘N’ denotes participants with data available at the specified time point.|||Percentage of days||Standard Error|Mean
2845006|NCT00118716|Secondary|Change From Baseline in Evening (PM) PEF|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication after the symptom measurement and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the evening. Change from baseline was calculated as the endpoint value minus the baseline value. Baseline was defined as the average of the values from the 7 days preceding Visit 2 (7-14 [+ or -4] days after Visit1) since these measures were derived from data collected in the evening.|Baseline and up to Week 4|ITT population. Here, ‘N’ denotes participants with data available at the specified time point.|||L/min||Standard Error|Mean
2845007|NCT00118716|Secondary|Change From Baseline in Morning Peak Expiratory Flow (AM PEF)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the morning. Change from baseline was calculated as the endpoint value minus the baseline value. For AM PEF, baseline was defined as the average of the AM PEF values recorded on the day of Visit 2 (7-14 [+ or -4] days after Visit1) plus the 6 preceding days since AM PEF was measured in the morning.|Baseline and Up to Week 4|ITT population. Here, ‘N’ denotes participants with data available at the specified time point.|||Liters/minute (L/min)||Standard Error|Mean
2845008|NCT00118716|Secondary|Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1|FEV1 AUC is mean AUC compared between treatment groups at Treatment Day 1. Baseline was defined as the pre-dose FEV1 measure from treatment Day 1. FEV1 AUC was calculated as the area of a trapezoid (calculated as the sum of the bases (top + bottom) divided by 2, then multiplied by width) above the baseline FEV1 area. For participants not completing a serial FEV1 measurement, the last observed post-dose FEV1 measurement was carried forward.|Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1|ITT population. Here, ‘N’ denotes participants with data available at the specified time point.|||Liters*hour||Standard Error|Mean
2845009|NCT00118716|Primary|Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4. FEV1 was measured 5, 10, 15, 30, and 60 minutes post-exercise. The minimum FEV1 measured across these time points, regardless of any missing time points, will be used for the calculation of maximal percent change.|Baseline and Week 4|Intent-to-Treat (ITT) population included all participants randomized to study drug. The number of participants available at that particular time point were used for analysis.|||Percent change||Standard Error|Mean
2845010|NCT00118703|Secondary|Number of Participants Based on Overall Evaluation of Response to Therapy|Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.|Week 4 (Day 29) or Early Withdrawal|ITT Population. Only participants available at the specified time point were analyzed.|||Participants|||Number
2845011|NCT00118703|Secondary|Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)|The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.|Baseline and up to Week 4|ITT population. Only participants available at the specified timepoint were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2845012|NCT00118703|Primary|Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian [PM] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.|Baseline and up to Week 4|Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2845013|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months||||participants||95% Confidence Interval|Number
2845014|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months||||participants||95% Confidence Interval|Number
2845015|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months||||participants||95% Confidence Interval|Number
2845016|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months||||participants||95% Confidence Interval|Number
2845017|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months||||participants||95% Confidence Interval|Number
2845058|NCT00118430|Primary|HSCL-20 Depression Severity|This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)|Measured at Year 1||||units on a scale||Standard Deviation|Mean
2845018|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months||||participants||95% Confidence Interval|Number
2845019|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months||||participants||95% Confidence Interval|Number
2845020|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months||||participants||95% Confidence Interval|Number
2845021|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months||||participants||95% Confidence Interval|Number
2845022|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months||||participants||95% Confidence Interval|Number
2845023|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months||||participants||95% Confidence Interval|Number
2845024|NCT00118534|Secondary|30-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months||||participants||95% Confidence Interval|Number
2845025|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months||||participants||95% Confidence Interval|Number
2845026|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months||||participants||95% Confidence Interval|Number
2845027|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months||||participants||95% Confidence Interval|Number
2845042|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months||||units on a scale||95% Confidence Interval|Mean
2845043|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months||||units on a scale||95% Confidence Interval|Mean
2845028|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months||||participants||95% Confidence Interval|Number
2845029|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months||||participants||95% Confidence Interval|Number
2845030|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months||||participants||95% Confidence Interval|Number
2845031|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months||||participants||95% Confidence Interval|Number
2845032|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months||||participants||95% Confidence Interval|Number
2845033|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months||||participants||90% Confidence Interval|Number
2845034|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months||||participants||95% Confidence Interval|Number
2845035|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months||||participants||95% Confidence Interval|Number
2845036|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months||||participants||95% Confidence Interval|Number
2845037|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months||||units on a scale||95% Confidence Interval|Mean
2845038|NCT00118534|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months||||units on a scale||95% Confidence Interval|Mean
2845039|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
2845040|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months||||units on a scale||95% Confidence Interval|Mean
2845044|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months||||units on a scale||95% Confidence Interval|Mean
2845045|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
2845046|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months||||units on a scale||95% Confidence Interval|Mean
2845047|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Mean
2845048|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months||||units on a scale||95% Confidence Interval|Mean
2845049|NCT00118534|Secondary|Clinician Administered PTSD Scale (CAPS)|"Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., Clinician-administered PTSD Scale: A Review of the First Ten Years of Research, Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline."|Baseline and 18 months||||Units on a scale||95% Confidence Interval|Mean
2845050|NCT00118534|Secondary|Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months|A secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.|between 6 and 18 months||||participants|||Number
2845051|NCT00118534|Primary|Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization|The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.|between 6 and 18 months||||participants|||Number
2845052|NCT00118482|Secondary|Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.|Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in patients on fludrocortisone vs placebo. Reported as RAND36 (Research ANd Development) score. The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Min value = 0 , Maximum value = 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 months||||score on a scale||Standard Deviation|Mean
2845053|NCT00118482|Secondary|Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.||Within 12 months|Data not analyzed because of variability of data collected on presyncope||||||
2845054|NCT00118482|Secondary|The Frequency of Syncope Will be the First Secondary Outcome Measure.|Frequency will be reported as 12- month syncope event rates (%)|Within 12 months||||rate %||95% Confidence Interval|Mean
2845055|NCT00118482|Primary|The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.|This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.|Within 12 months||||Participants|||Count of Participants
2845056|NCT00118430|Secondary|Primary Care Visits||Measured at Year 1|The no treatment group did not have depression and was followed simply as a cohort and not part of the clinical trial. Therefore we did not measure this secondary outcome of primary care visits in the no treatment group.|||number of primary care visits||Standard Deviation|Mean
2845057|NCT00118430|Secondary|Graded Chronic Pain Scale Disability Score|This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)|Measured at Year 1||||units on a scale||Standard Deviation|Mean
2845072|NCT00118365|Secondary|Biomarker in Adenoma: Sialyl-TN (B72.3)|sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.|||Adenoma|Participants||Number
2845059|NCT00118430|Primary|Brief Pain Inventory Interference|The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).|Measured at Year 1||||units on a scale||Standard Deviation|Mean
2845060|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 2 (Week 12) and Phase 3 (Week 24)||||Points on a scale||Standard Deviation|Mean
2845061|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 1 (Week 6) and Phase 2 (Week 12)||||Points on a scale||Standard Deviation|Mean
2845062|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured at baseline and after Phase 1 (6 weeks)|Analyses in each study phase were for a modified intent to treat (ITT) sample, defined as all participants who had at least one on-treatment assessment during that phase.|||Points on a scale||Standard Deviation|Mean
2845063|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)."|Measured at month 32|Intention to treat analysis|||% patients who relapsed/recurred|||Number
2845064|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 20|Intention to treat analysis|||% patients who relapsed/recurred|||Number
2845065|NCT00118404|Primary|Depressive Relapse or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 8|Intention to treat analysis|||% patients who relapsed|||Number
2845066|NCT00118378|Secondary|HIV RNA Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Log10 copies/mL||Standard Deviation|Mean
2845067|NCT00118378|Secondary|CD4 Cell Count|CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Cells/mcL||Standard Deviation|Mean
2845068|NCT00118378|Primary|Role Function Scale Outcome|The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
2845069|NCT00118378|Primary|Fatigue Severity Scale (FSS)|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
2845070|NCT00118365|Secondary|Biomarker in Adenoma: Bcl-2|bcl-2 is the anti-apoptotic protein BCL2|At the end of the study, up to 3 years|The analysis cohort is based on the participants whose data are available.|||Adenoma|Participants||Number
2845071|NCT00118365|Secondary|Biomarker in Adenoma - p53|"Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.~Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene."|At the end of the study|The analysis cohort is based on the participants whose data are available.|||percentage of cells that are positive||95% Confidence Interval|Mean
2845074|NCT00118365|Secondary|Biomarker in Adenoma - Ki-67|Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates|At the end of the study|The analysis cohort is based on the participants whose data are available.|||percentage of cells that are positive||95% Confidence Interval|Mean
2845075|NCT00118365|Secondary|Biomarker in Adenoma: Apoptosis|Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.|At the end of the study|The analysis cohort is based on the participants whose data are available.|||adenoma|Participants||Number
2845076|NCT00118365|Secondary|Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845077|NCT00118365|Secondary|At the End of the Study - Spermine Response by ODC Genotype|"Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845078|NCT00118365|Secondary|At the End of the Study - Spermidine Response by ODC Genotype|"Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845079|NCT00118365|Secondary|At the End of the Study - Putrescine Response by ODC Genotype|"Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845080|NCT00118365|Secondary|Baseline Spermine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.|||nmol/mg protein||Full Range|Median
2845081|NCT00118365|Secondary|Baseline Spermidine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.|||nmol/mg protein||Full Range|Median
2845082|NCT00118365|Secondary|Baseline Putrescine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.|||nmol/mg protein||Full Range|Median
2845083|NCT00118365|Secondary|Adverse Events With a Grade of 3 and Above|"Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.~Per protocol, not all grade 3 events are considered as serious events."|Up to 36 months||||participants|||Number
2845084|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment|Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845085|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment|Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845086|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment|PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845145|NCT00117949|Secondary|Liver Function Tests|The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months||||participants|||Number
2845087|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment|"The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.~In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.~The analysis cohort is based on the participants whose data are available and complete."|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845088|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment|The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.|||participants|||Number
2845089|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.|||participants|||Number
2845090|NCT00118365|Primary|Detection of Any Adenoma at the End of the Study|Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done.|||participants|||Number
2845091|NCT00118352|Secondary|Disease Progression/Relapse|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|Up to 5 years||||percentage of participants|||Number
2845092|NCT00118352|Secondary|Immune Reconstitution|The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.|Up to 1 year post-transplant|||||||
2845093|NCT00118352|Secondary|Incidence of Infection|Percentage patients that experienced infection(s).|Up to 5 years post-transplant||||percentage of participants|||Number
2845094|NCT00118352|Secondary|Incidence of Non-relapse Mortality|Percentage patient deaths due to non-relapse mortality|100 days after transplant||||percentage of participants|||Number
2845095|NCT00118352|Secondary|Incidence of High-dose Corticosteroid Utilization.|Percentage patients requiring steroids greater than 1 mg/kg.|100 days after transplant||||percentage of participants|||Number
2845096|NCT00118352|Secondary|Incidence of Graft Rejection|Percentage patients that experienced graft rejection.|84 days after transplant||||percentage of participants|||Number
2845097|NCT00118352|Primary|Incidence of Grade III-IV Acute GVHD|"Severity of Individual Organ Involvement~Liver:~Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml~Gut:~Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall~Severity of GVHD~Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|100 days after transplant||||percentage of participants|||Number
2845098|NCT00118287|Primary|Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria|Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.|Up to 2 years||||Participants|||Count of Participants
2845099|NCT00118248|Secondary|Toxicity|Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)|All participants were evaluable for this endpoint.|||participants|||Number
2845100|NCT00118248|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.|Every 3 months until progression, and then every 6 months up to 3 years|All patients were evaluable for this endpoint.|||years||95% Confidence Interval|Median
2845508|NCT00115349|Secondary|Change in Left Ventricular (LV) Volume From Screening to One Year.||one year|||||||
2845101|NCT00118248|Secondary|Progression-Free Survival|Defined as the time from registration to the date of progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method.|Every 3 months for up to 3 years|All participants were evaluable for this endpoint.|||months||95% Confidence Interval|Median
2845102|NCT00118248|Secondary|Overall Response|"The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0.~Complete Response (CR): Disappearance of all lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Baseline, every 3 courses, and at the end of treatment study|All participants were evaluated for response.|||participants|||Number
2845103|NCT00118248|Primary|Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)|"The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free."|1 year|All patients were evaluable for this endpoint in this group.|||percentage of participants||90% Confidence Interval|Number
2845104|NCT00118209|Other Pre-specified|Whether the Gene Expression Signatures That Were Previously Associated With Survival Following CHOP Therapy Are Associated With Survival in Either of the Treatment Arms of the Prospective Trial||Up to 5 years post-registration|||||||
2845105|NCT00118209|Secondary|Overall Survival Rate at 2 and 5 Years|Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below.|Up to 5 years post-registration||||percentage of participants||95% Confidence Interval|Number
2845106|NCT00118209|Secondary|Response Rate|The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response)|Up to 5 years post-registration||||percentage of participants|||Number
2845107|NCT00118209|Primary|Progression-Free Survival Rate at 2 and 5 Years|"Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse >~≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. >~Appearance of any new lesion during or after completion of therapy. >~PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven. >~The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below."|Up to 5 years post-registration||||percentage of participants||95% Confidence Interval|Number
2845108|NCT00118157|Secondary|Changes in Phosphorylation in Tumor Tissue of Epidermal Growth Factor Receptor (EGFR), HER2, AKT Kinase, MAPK, ER-Ser118, and ER-SER167||Baseline and at 21 days|Data were not collected due to feasibility.||||||
2845109|NCT00118157|Primary|Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)||4 weeks||||participants||95% Confidence Interval|Number
2845110|NCT00118144|Secondary|Overall Survival|Overall Suvival using the product-limit method of Kaplan and Meier.|Up to 5 years||||Months||95% Confidence Interval|Mean
2845111|NCT00118144|Secondary|Progression-free Survival|Progression Free Survival using the product-limit method of Kaplan and Meier|Up to 5 years||||Months||95% Confidence Interval|Median
2845112|NCT00118144|Primary|Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.|A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.|Up to 5 years||||percentage of responders|||Number
2845113|NCT00118131|Secondary|Median Survival Time||10 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||months||95% Confidence Interval|Median
2845114|NCT00118131|Secondary|1-year Survival Rate||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||1-year survival rate (percentage)|||Number
2845115|NCT00118131|Secondary|Time to Progressive Disease||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||months||95% Confidence Interval|Median
2845116|NCT00118131|Primary|Overall Tumor Response Rate|Patients experiencing complete or partial response|7 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.|||Response rate (percentage)|||Number
2845117|NCT00118092|Secondary|Duration of PSA Response and PSA Control|"The distribution of this response duration will be estimated using the method of Kaplan-Meier. In patients whose PSA has declined from baseline by at least 30 %, duration of PSA response will be defined as the time from PSA response to time of progression. If a patient goes on to alternate therapy, they will be censored at the date they end treatment on this study. Duration of PSA Control is defined as the time from the date of the first 30% decline in PSA until an inflection point is identified. Inflection point is defined as the time to first consistent PSA increase, the point at which PSA began what becomes a continuous increase~> (retrospectively identified). The inflection point is the point at which disease control could assume to be lost."|From PSA response to time of progression, assessed up to 1 year|No participants with PSA response or PSA control.||||||
2845243|NCT00117572|Secondary|Quality of Life (FACT H&N)|FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845118|NCT00118092|Secondary|Disease-free Survival|Disease-free survival time is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had progressed at the time of their death. In patients who have achieved a PSA response, we will assess the time to PSA progression. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 3 years|All 15 eligible patients that started treatment were evaluated.|||months||95% Confidence Interval|Median
2845119|NCT00118092|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All 15 eligible patients that started treatment were evaluated.|||months||95% Confidence Interval|Median
2845120|NCT00118092|Secondary|Proportion of Overall Responses|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions.~The proportion of confirmed responses will be estimated by the number of patients with confirmed responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|Up to 3 years|All 15 eligible patients that started treatment were evaluated.|||percentage of responses||95% Confidence Interval|Number
2845121|NCT00118092|Primary|PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group|"Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. > > 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response. >~> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only."|Up to 1 year|All 15 eligible patients that started treatment were evaluated.|||participants|||Number
2845122|NCT00118053|Secondary|Pathologic and Molecular Markers for Predicting Efficacy||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
2845123|NCT00118053|Secondary|Disease-free Survival||10 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
2845124|NCT00118053|Secondary|Pathological Complete Response||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
2845125|NCT00118053|Primary|Antitumor Activity as Measured by Response Rate||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.||||||
2845126|NCT00118040|Secondary|pMAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, pMAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of pMAP Kinase strength signa|||Number
2845127|NCT00118040|Secondary|MAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, MAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of MAP Kinase strength signal|||Number
2845128|NCT00118040|Secondary|pAKT in Tumor Tissue|"Detecting the signal of the biomarker, pAKT, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of pAKT strength signal|||Number
2845129|NCT00118040|Secondary|AKT in Tumor Tissue|"Detecting the signal of the biomarker, AKT, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of AKT strength signal|||Number
2845130|NCT00118040|Secondary|COX2 in Tumor Tissue|"Detecting the signal of the biomarker, COX2, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of COX2 strength signal|||Number
2845304|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Apoprotein B (apoB)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845131|NCT00118040|Secondary|Activated Caspase 3 in Tumor Tissue|"Detecting the signal of the biomarker, Activated Caspase 3, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of Caspase 3 strength signal|||Number
2845132|NCT00118040|Secondary|Ki-67 in Tumor Tissue|"Detecting the signal of the biomarker, Ki-67, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of Ki-67 strength signal|||Number
2845133|NCT00118040|Secondary|EGFR in Benign Tissue|"Detecting the signal of the biomarker, EGFR, in the benign tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.|||percentage of EGFR strength signal|||Number
2845134|NCT00118040|Primary|pEGFR in Benign Tissue|"Detecting the signal of the biomarker, pEGFR, in the benign tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.|||percentage of pEGFR strength signal|||Number
2845135|NCT00118040|Secondary|EGFR Mutations in Tumor Tissue|"Detecting the signal of EGFR mutations in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of EGFR strength signal|||Number
2845136|NCT00118040|Secondary|Survivin in Tumor Tissue|"Detecting the signal of the biomarker, Survivin, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of Survivin strength signal|||Number
2845137|NCT00118040|Secondary|Survivin in Urine by Visit (pg/ml)|Detecting the mean amount of the biomarker Survivin in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 16 for this outcome.|||pg/ml||Standard Deviation|Mean
2845138|NCT00118040|Secondary|BLCA-4 in Urine by Visit|Detecting the mean amount of the biomarker BLCA-4 in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 17 for this outcome.|||pg/ml||Standard Deviation|Mean
2845139|NCT00118040|Primary|Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment|Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.|||percentage of pEGFR strength signal|||Number
2845140|NCT00117988|Primary|Number of Patients With Response|Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.|Baseline to time to best response; Every 6 weeks|Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included.|||participants|||Number
2845141|NCT00117962|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 4 years)||||months||95% Confidence Interval|Median
2845142|NCT00117962|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 4 years)||||participants|||Number
2845143|NCT00117962|Secondary|Failure-free Survival|Failure-free survival (FFS) is the time from randomization to a failure event, defined as disease progression or death from any cause (which ever occurred first). The median FFS with 95% CI was estimated using the Kaplan-Meier method,|Time from randomization to failure (up to 4 years)||||months||95% Confidence Interval|Median
2845509|NCT00115349|Secondary|Evaluate Whether L1/DFO Combination Therapy is Superior to DFO Monotherapy in Lowering Myocardial Iron Burden Estimated by Myocardial T2*.||one year|||||||
2845146|NCT00117949|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).|||days||Full Range|Median
2845147|NCT00117949|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).|||days||Full Range|Median
2845148|NCT00117949|Primary|Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days|"The number of participants suppressed for at least 28 days was defined as the estimated survival probability at time=Day 28."|28 days||||participants|||Number
2845149|NCT00117949|Secondary|Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days|Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months||||participants|||Number
2845150|NCT00117949|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.|1, 3, 7, 14, 21, 28, 42 days|Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.|||days|||Number
2845151|NCT00117949|Primary|Time to Meet Insufficient Testosterone Response|Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months|Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).|||days||Full Range|Median
2845152|NCT00117845|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 72 months||||Participants|||Count of Participants
2845153|NCT00117845|Primary|Response Rate|Response rate is based on the number of patients who achieve either a complete response (CR) or partial response (PR) to therapy. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Partial response is reduction by >=50% of leukemia cell count or >=50% reduction is the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|up to 12 months||||Participants|||Count of Participants
2845154|NCT00117806|Primary|Competitive Employment-Percentage of Participants With Competitive Employment|Employment outcomes during year 1 among those subjects obtaining competitive employment.|12 months||||percentage of participants||95% Confidence Interval|Number
2845155|NCT00117806|Primary|Competitive Employment-Participants With Competitive Employment|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months||||Participants with competitive employment|||Number
2845156|NCT00117806|Primary|Competitive Employment-Total Jobs|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months||||Total Competitive Employments|||Number
2845157|NCT00117793|Secondary|Frustration (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. Frustration was assessed by frequency of occurrence and rating. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., least frustrating).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||units on a scale||Standard Deviation|Mean
2845158|NCT00117793|Secondary|Ambulation (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Ambulation scale queries the ability to walk in general, in close spaces, on stairs and ramps, in urban environments, and on slippery surfaces. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., easiest to walk on).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||units on a scale||Standard Deviation|Mean
2847760|NCT00098254|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 1/2 years||||Participants|||Number
2845159|NCT00117793|Secondary|Residual Limb Health (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Residual Limb Health scale examines: sweat, smell, volume changes, rashes, ingrown hairs, and blisters. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., most healthful).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||units on a scale||Standard Deviation|Mean
2845160|NCT00117793|Primary|Limb Pistoning|Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.|Measurements were taken after wearing the study prosthesis for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||mm||Standard Deviation|Mean
2845161|NCT00117793|Primary|Activity Level|Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).|Two weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||steps (in thousands)||Standard Deviation|Mean
2845162|NCT00117793|Primary|Limb Volume||Measurements were taken after wearing the study prostheses for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.|||liters||Standard Deviation|Mean
2845163|NCT00117715|Primary|Change in CYP1A2 Drug Metabolism Phenotype With Age|Concentrations of caffeine metabolites 5-Acetylamino-6-amino-3-methyluracil (AAMU), 1-methylxanthine (1MX), 1-methyluric acid (1MU), and 1,7-dimethyluric acid (17MU) are quantified in urine and used to estimate the activity of cytochrome P450 1A2 using the well established (AAMU+1MX+1MU)/1,7U ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. (AAMU+1MX+1MU)/1,7U ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.|||unitless ratio||Standard Deviation|Mean
2845164|NCT00117715|Primary|Change in CYP3A4 Drug Metabolism Phenotype With Age|Concentrations of dextromethorphan (DM) metabolites 3-hydroxymorphinan (3HM) and dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochrome P450 3A4 using the well established 3HM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. 3HM/DX ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.|||unitless ratio||Standard Deviation|Mean
2845165|NCT00117715|Primary|Change in CYP2D6 Drug Metabolism Phenotype With Age|Concentrations of dextromethorphan(DM) and it's metabolite dextrorphan (DX) are quantified in urine and used to estimate the activity of cytochromes P450 2D6 using the well established DM/DX ratio. The longitudinal study design allows for changes in drug metabolism activity as a function of age which can be characterized via least squares regression where the slope of age vs. DM/DX ratio is examined for deviations from zero.|every 6 months for 5 years|Participants completing each milestone visit at each 0.5 years of age.|||unitless ratio||Standard Deviation|Mean
2845166|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 433 to 480|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 432 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845167|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 385 to 432|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 384 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845168|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845169|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845305|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845170|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845171|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845172|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845173|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845174|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 96|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845175|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 48, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845176|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845177|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 96. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
2845178|NCT00117676|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion Antibody to HBs (Anti-HBs) at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed. The missing = failure approach was used.|||percentage of participants|||Number
2845179|NCT00117676|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units per liter||Standard Deviation|Mean
2845244|NCT00117572|Secondary|Quality of Life (McMaster)|McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845180|NCT00117676|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units per liter||Standard Deviation|Mean
2845181|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 432 and 480|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845182|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845183|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845184|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845185|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845186|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845187|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units on a scale||Standard Deviation|Mean
2845188|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2845189|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845190|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845191|NCT00117676|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
2845192|NCT00117676|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
2845193|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480||Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845194|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845195|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
2845196|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845197|NCT00117676|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845198|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 45 subjects in Sorafenib 400/600 mg bid group and 58 in Interferon/Sorafenib 400 mg bid group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)|||participant s|||Number
2845199|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 95 subjects in Sorafenib 400 mg bid group and 89 in Interferon group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)|||participants|||Number
2845200|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the Second Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks||||months||Full Range|Median
2845201|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks||||months||Full Range|Median
2845202|NCT00117637|Secondary|Time to Response According to the Independent Radiological Review for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 15 months later, assessed every 8 weeks||||months||Full Range|Median
2845203|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the Second Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||Full Range|Median
2845204|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||Full Range|Median
2845205|NCT00117637|Secondary|Duration of Response According to the Independent Radiological Review for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 15 months later, assessed every 8 weeks||||months||Full Range|Median
2845206|NCT00117637|Secondary|Average of All Trough Plasma Concentrations|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID).|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg or 600 mg BID) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.|||100*mg/L||95% Confidence Interval|Geometric Mean
2845207|NCT00117637|Secondary|Slope - Change in Trough Concentration/Cycle|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time.|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.|||100*(mg/L/cycle)||95% Confidence Interval|Mean
2845208|NCT00117637|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
2845209|NCT00117637|Secondary|Progression Free Survival According to the Investigator Assessment (Second Intervention Period)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
2845210|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the Second Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
2845211|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
2845212|NCT00117637|Secondary|Tumor Response According to the Independent Radiological Review for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks||||participants|||Number
2845213|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845214|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845215|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845216|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845217|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845218|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845219|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845220|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845245|NCT00117572|Secondary|Quality of Life (Speech)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845221|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the Second Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845222|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the First Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845223|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845224|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the First Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845225|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845226|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) After Intervention for the First Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2845227|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
2845246|NCT00117572|Secondary|Quality of Life (Normalcy of Diet)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845651|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 2-3 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age|||Percentage of FluMist recipients|||Number
2845228|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||participants|||Number
2845229|NCT00117637|Secondary|Disease Control (DC) According to Independent Central Review for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks||||participants|||Number
2845230|NCT00117637|Secondary|Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
2845231|NCT00117637|Primary|Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 15 months later, assessed every 8 weeks||||months||95% Confidence Interval|Median
2845232|NCT00117598|Other Pre-specified|Time to Tumor Progression (TTP)|TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT|||months||95% Confidence Interval|Median
2845233|NCT00117598|Other Pre-specified|Time to Failure (TTF)|TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT|||months||95% Confidence Interval|Median
2845234|NCT00117598|Other Pre-specified|Duration of Response|Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants who had a response|||months||95% Confidence Interval|Median
2845235|NCT00117598|Other Pre-specified|Time to Response|Time between the date of randomization and the first date of objective response for participants with a confirmed objective response.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants with a confirmed objective response|||months||95% Confidence Interval|Median
2845236|NCT00117598|Other Pre-specified|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to 5 years|ITT|||months||95% Confidence Interval|Median
2845237|NCT00117598|Secondary|Percentage of Participants With Objective Response|Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT|||percentage of participants||95% Confidence Interval|Number
2845238|NCT00117598|Primary|Progression-Free Survival (PFS)|The period from randomization until disease progression, death or date of last contact.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Intent-to-Treat (ITT) Population: All randomized participants at time of primary analysis|||months||95% Confidence Interval|Median
2845239|NCT00117585|Primary|Orthostatic Hypotension at Discharge|Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.|Last three blood pressures prior to discharge||||participants|||Number
2845240|NCT00117572|Secondary|Quality of Life (McMaster)|McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845241|NCT00117572|Secondary|Quality of Life (Speech)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845242|NCT00117572|Secondary|Quality of Life (Normalcy of Diet)|Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)|Change from baseline to 1 year (1 year-pre)|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845247|NCT00117572|Secondary|Quality of Life (FACT H&N)|FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)|Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.|Survivors who completed the questionnaire. (Patients with missing data excluded.)|||units on a scale||Standard Error|Mean
2845248|NCT00117572|Secondary|Failure Pattern (Distant Recurrence)|Percentage of patients with distant recurrence|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
2845249|NCT00117572|Secondary|Failure Pattern (Local/Regional Recurrence)|Percentage of patients with local/regional recurrence|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
2845250|NCT00117572|Secondary|Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause|Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
2845251|NCT00117572|Secondary|Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause|DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
2845252|NCT00117572|Primary|Overall Survival: Time From Randomization to Death From Any Cause|Survival rates over 6 years.|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
2845253|NCT00117559|Primary|BDI|"Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression~The Beck Depression Inventory (BDI; Beck & Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is I do not feel sad. The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, & Garbing, 1988). Cronbach's alpha was high for the present sample at both time points (a = .91 and .90)."|8 weeks||||units on a scale||Standard Deviation|Mean
2845254|NCT00117338|Secondary|Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration|Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.|120 minutes|At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint.|||mg||Inter-Quartile Range|Median
2845255|NCT00117338|Secondary|Change in FEV1 After 15 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value|Baseline and 15 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
2845256|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighted average over) 30 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
2845257|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighed average over) 45 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
2845258|NCT00117338|Secondary|Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)|Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.|120 minutes|Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model.|||Participants|||Number
2845259|NCT00117338|Secondary|Change From Baseline in Modified Pulmonary Index [mPI] Score|"Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.~The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use."|Baseline and 60 minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2845260|NCT00117338|Primary|Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration|Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time weighted average over) 60 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.|||Liters||95% Confidence Interval|Least Squares Mean
2845261|NCT00117325|Secondary|Mean Scores Changes From Baseline as a Function of Time|The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days|RITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845262|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip|The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845263|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip|The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845264|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip|The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845265|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845266|NCT00117325|Secondary|Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS|The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change in score||Standard Error|Least Squares Mean
2845267|NCT00117325|Secondary|Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS|The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change in score||Standard Error|Least Squares Mean
2845277|NCT00117156|Post-Hoc|Delayed Pneumonia Toxicity Rate|Delayed pneumonia toxicity rate is the proportion of patients who experienced significant pneumonia toxicity defined as nocardia or pneumocystis jiroveci after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
2845783|NCT00113425|Primary|Change From Baseline in Acne Severity at Week 10|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 10||||units on a scale||95% Confidence Interval|Mean
2845268|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS|The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT Population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845269|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|RITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845270|NCT00117325|Secondary|Number of Participants With Overall Evaluation of Response to Therapy|The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.|Up to 4 weeks|RITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2845271|NCT00117325|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)|The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2845272|NCT00117325|Primary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)|The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).|Baseline (4 days prior to randomization [Day 1]) and up to Week 4|Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites.|||Score on scale||Standard Error|Least Squares Mean
2845273|NCT00117312|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).|||participants|||Number
2845274|NCT00117312|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.|||participants|||Number
2845275|NCT00117286|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.|||participants|||Number
2845276|NCT00117286|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.|||participants|||Number
2845784|NCT00113425|Primary|Change From Baseline in Erythematous Macules at Week 10||Baseline and Week 10||||erythematous macules||95% Confidence Interval|Mean
2845278|NCT00117156|Post-Hoc|Delayed Bone Marrow Toxicity Rate|Delayed bone marrow toxicity rate is the proportion of patients who experienced significant bone marrow toxicity defined as aplastic anemia or myelodysplastic syndromes (MDS) after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
2845279|NCT00117156|Secondary|3.1-Year Overall Survival|3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry.|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
2845280|NCT00117156|Secondary|3.1-Year Progression-Free Survival|3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999).|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
2845281|NCT00117156|Primary|Objective Response Rate|Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).|Assessed after three- and six-cycles of therapy.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
2845282|NCT00117143|Secondary|Duration Within the Targeted Therapeutic Range|"Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L.~Platelet count data after the use of rescue medication were not included."|From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78|Participants who received at least 1 dose of romiplostim with a targeted therapeutic response.|||days||Full Range|Median
2845283|NCT00117143|Secondary|Time to Peak Platelet Count|Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included.|From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78|Participants who received at least 1 dose of romiplostim with available data.|||days||Full Range|Median
2845284|NCT00117143|Secondary|Change From Baseline to Peak Platelet Level|Platelet count data after the use of rescue medication were not included.|Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)|Participants who received at least 1 dose of romiplostim with available data.|||10⁹ cells/L||Standard Deviation|Mean
2845285|NCT00117143|Secondary|Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L|Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.|After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)|Participants who received at least 1 dose of romiplostim.|||Participants|||Count of Participants
2845286|NCT00117143|Secondary|Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L|Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.|After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants)|Participants who received at least 1 dose of romiplostim.|||Participants|||Count of Participants
2845287|NCT00117143|Secondary|Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline|Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.|Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)|Participants who received at least 1 dose of romiplostim.|||Participants|||Count of Participants
2845288|NCT00117143|Secondary|Number of Participants Who Achieved a Targeted Therapeutic Platelet Response|"Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 10⁹ cells/L.~Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders."|Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants)|Participants who received at least 1 dose of romiplostim.|||Participants|||Count of Participants
2845289|NCT00117143|Primary|Number of Participants With Positive Anti-Romiplostim Antibodies|The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.|Days 29 and 78|Participants who received at least 1 dose of romiplostim|||Participants|||Count of Participants
2845290|NCT00117143|Primary|Number of Participants With Adverse Events||From first dose through 8 weeks after last dose of study drug (11 weeks)|Participants who received at least 1 dose of romiplostim|||Participants|||Count of Participants
2845291|NCT00116857|Primary|Beck Depression Inventory-II|Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.|Measured at Baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2845303|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||Ratio||Standard Error|Mean
2845785|NCT00113425|Primary|Change From Baseline in Open Comedones at Week 10||Baseline and Week 10||||open comedones||95% Confidence Interval|Mean
2845292|NCT00116844|Secondary|Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study|Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2845293|NCT00116844|Secondary|Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding|"The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions)."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||DNA copies per day||Standard Deviation|Mean
2845294|NCT00116844|Secondary|Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding|"The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions)."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||DNA copies per day||Standard Deviation|Mean
2845295|NCT00116844|Secondary|Number of Participants With no Shedding|"The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions)."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2845296|NCT00116844|Secondary|Mean Percent Days of Total HSV-2 Shedding|"The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period."|Up to Day 60 of each treatment period (up to 160 days)|ITTC population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of days||Standard Deviation|Mean
2845297|NCT00116844|Primary|Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2|Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.|Up to Day 60 of each treatment period (up to 160 days)|The intent-to-treat crossover (ITTC) population was defined as consisting of all participants who received at least one dose of investigational product and had at least one PCR swabbing result in each treatment period. Only those participants with data available at the indicated time points were analyzed.|||Percentage of days||Standard Deviation|Mean
2845298|NCT00116831|Secondary|Number of Other Cardiovascular Events|This was one of the secondary endpoints of the study.|Baseline to Month 21|Safety Population|||Number of events|||Number
2845299|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population|||Participants|||Number
2845300|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population|||Participants|||Number
2845301|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||ratio||Standard Error|Mean
2845302|NCT00116831|Secondary|Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||ratio||Standard Error|Mean
2845306|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Triglycerides (TG)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845307|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845308|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-3|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845309|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-2|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845310|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845311|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Total Cholesterol (TC)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845312|NCT00116831|Secondary|Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.|Baseline to Month 18|ITT Population with LOCF|||percent change|||Number
2845313|NCT00116831|Secondary|Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.|Baseline to Month 18|ITT Population with LOCF|||percent change|||Number
2845314|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845315|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||percent change|||Number
2845316|NCT00116831|Secondary|Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF|||millimole/Liter (mmol/L)||Standard Error|Mean
2845317|NCT00116831|Secondary|Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.|Baseline to Month 18|Intent-to-Treat (ITT) Population without Last Observation Carried Forward (LOCF). ITT population was defined as all participants in the study who were randomized and have at least one on-therapy value for an efficacy assessment.|||Percentage||Standard Error|Mean
2845318|NCT00116831|Secondary|Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters squared (mm2)||Standard Error|Mean
2845319|NCT00116831|Secondary|Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters squared (mm2)||Standard Deviation|Mean
2845320|NCT00116831|Secondary|Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters cubed (mm3)||Standard Error|Mean
2845321|NCT00116831|Secondary|Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)|||millimeters cubed (mm3)||Standard Deviation|Mean
2845786|NCT00113425|Primary|Change From Baseline in Closed Comedones at Week 10||Baseline and Week 10||||closed comedones||95% Confidence Interval|Mean
2845322|NCT00116831|Secondary|Model Adjusted Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
2845323|NCT00116831|Primary|Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)|||percent (absolute change)||Standard Error|Mean
2845324|NCT00116831|Primary|Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)|||percent (absolute change)||Standard Deviation|Mean
2845325|NCT00116831|Secondary|Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Deviation|Mean
2845326|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters square (mm2)||Standard Error|Mean
2845327|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters square (mm2)||Standard Error|Mean
2845328|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters square (mm2)||Standard Error|Mean
2845329|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population|||millimeters squared (mm2)||Standard Deviation|Mean
2845330|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
2845331|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
2845332|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Error|Mean
2845333|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population|||millimeters cubed (mm3)||Standard Deviation|Mean
2845334|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 480 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 433 to 480|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 432 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845335|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 432 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 385 to 432|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 384 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845345|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
2845336|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845337|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845338|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845339|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845340|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845341|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845342|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 96|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845343|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.|||participants|||Number
2845344|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, 384, 432, and 480|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845369|NCT00116779|Secondary|Number of Participants With Abnormal Total Bilirubin Values|Participants with abnormal total bilirubin values|Day 1 - 364|ITT population|||participants|||Number
2845370|NCT00116779|Secondary|Number of Participants With Abnormal Aspartate Aminotransferase Values|Participants with aspartate aminotransferase values that were above the normal range.|Day 1 - 364|ITT population|||participants|||Number
2845346|NCT00116805|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with available data were analyzed.|||percentage of participants|||Number
2845347|NCT00116805|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion to Anti-HBe at Week 96|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
2845348|NCT00116805|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss/Seroconversion at Week 48|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed.|||percentage of participants|||Number
2845349|NCT00116805|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||U/L||Standard Deviation|Mean
2845350|NCT00116805|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||U/L||Standard Deviation|Mean
2845351|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 432 and 480|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845352|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845353|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Week 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845354|NCT00116805|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845355|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845356|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845787|NCT00113425|Primary|Change From Baseline in Cysts at Week 10||Baseline and Week 10||||cysts||95% Confidence Interval|Mean
2845357|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||units on a scale||Standard Deviation|Mean
2845358|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2845359|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845360|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845361|NCT00116805|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480||Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 IU/mL||Standard Deviation|Mean
2845362|NCT00116805|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.|||log10 IU/mL||Standard Deviation|Mean
2845363|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 432 and 480||Weeks 432 and 480|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added emtricitabine to their open-label TDF regimen were included in the analysis.|||percentage of participants|||Number
2845364|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845365|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who discontinued study unless the discontinuation was unrelated to protocol criteria.|||percentage of participants|||Number
2845366|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845367|NCT00116805|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2845368|NCT00116779|Secondary|Participants With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61|||participants|||Number
2845376|NCT00116779|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.|Day 0 (post dose) to Day 364|ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.|||days||Full Range|Median
2845377|NCT00116779|Secondary|Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population|||days||Full Range|Median
2845378|NCT00116779|Primary|Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28|Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.|Day 28 - Day 364|ITT population of participants who completed the study and had a testosterone level of <=0.5 nanogram per milliliter at Day 28.|||participants|||Number
2845379|NCT00116779|Secondary|Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.|Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.|Day 3|ITT population|||participants|||Number
2845380|NCT00116779|Primary|Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364|Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364|Day 28 to Day 364|ITT population of patients who completed the study and had testosterone <=0.5 nanogram per milliliter at Day 28.|||participants|||Number
2845381|NCT00116753|Secondary|Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|12 or 13 months|ITT population.|||participants|||Number
2845382|NCT00116753|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|12 or 13 months|ITT population.|||participants|||Number
2845383|NCT00116753|Secondary|Number of Participants With Testosterone <=0.5 ng/mL at Day 28|Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.|28 Days|Observed Cases in ITT population.|||participants|||Number
2845384|NCT00116753|Secondary|Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study|Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.|From after Day 28 to 12 or 13 months|Observed Cases in ITT population.|||participants|||Number
2845385|NCT00116753|Primary|Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study|Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.|From Day 28 to 12 or 13 months|Observed Cases in ITT population.|||participants|||Number
2845386|NCT00116688|Secondary|Patient Global Assessment|The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.|Week 1 and Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
2845387|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent's self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
2845388|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Index Score|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
2845389|NCT00116688|Secondary|Change From Baseline in Short Form 36 (SF-36)|The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
2845390|NCT00116688|Secondary|Change From Baseline in ITP Patient Assessment Questionnaire|The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women's Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.|||scores on a scale||Standard Deviation|Mean
2845391|NCT00116688|Secondary|Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies|The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.|Duration of treatment (up to 277 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.|||Participants|||Number
2845392|NCT00116688|Secondary|Number of Participants With a Platelet Response|Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.|Duration of treatment (up to 277 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim|||Participants|||Number
2845393|NCT00116688|Primary|Number of Participants With Adverse Events|Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.|Duration of treatment plus 8 weeks (up to 285 weeks)|Safety Analysis Set, composed of all participants who received at least one dose of romiplostim|||Participants|||Number
2845394|NCT00116649|Secondary|Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count|Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count|At Month 18|The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit|||percent reduction||Standard Deviation|Mean
2845395|NCT00116649|Primary|Number of Participants Who Experienced an Adverse Event|Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.|from first dose up to 18 months|There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.|||participants|||Number
2845396|NCT00116558|Other Pre-specified|Tolerance of NIPPV Treatment|Percent of patients achieving tolerance (>4hr/night NIPPV after 2-3 week titration period) determined by actual usage data.|one month|"No data were collected for the Standard of Care NIIPPV and Nutritional Monitoring arm."|||Participants|||Count of Participants
2845397|NCT00116558|Other Pre-specified|Total Daily Energy Expediture (TDEE) of ALS Patients|Total daily energy expenditure (TDEE) with be measured using the dual labeled water (DLW) method|Duration of study (approximately 1 year)|||||||
2845398|NCT00116558|Other Pre-specified|Compliance With NIPPV Treatment|Number of hours of NIPPV use per month|one month|||||||
2845399|NCT00116558|Other Pre-specified|Patient Survival With Early Versus Standard of Care NIPPV Treatment|Duration of patient survival|one year|||||||
2845400|NCT00116558|Primary|Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment.|Percentage of patients attempting to use NIPPV therapy within six weeks of initial offer.|6 weeks|"Data were not obtained from the Standard of Care NIPPV and Nutritional Monitoring arm."|||Participants|||Count of Participants
2845401|NCT00116428|Secondary|Percentage of Subjects Responded to Each of the Four Health Status Categories.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed the two-year health survey.|||Percentage of Participants|||Number
2845402|NCT00116428|Secondary|Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed two years follow up|||Percentage of Participants|||Number
2845403|NCT00116428|Secondary|The Percentage of Subjects Who Achieved Acute Success.|Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.|90 days post study procedure|This analysis population is based on the first study ablation procedure.|||Percentage of participants|||Number
2845404|NCT00116428|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.|Within 7 Days of Ablation Procedure|Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.|||Percentage of Participants|||Number
2845405|NCT00116428|Primary|The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)|Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.|The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.||||Percentage of participants|||Number
2845406|NCT00116337|Secondary|Trained Caregiver Support for Secretion Clearance|The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up.|baseline (pre-implant) and 1 year follow up (post-implant)|Male - 14; Female - 3|||times/week||Standard Error|Mean
2845407|NCT00116337|Secondary|Incident of Acute Respiratory Tract Infections|The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked over the 2-year period prior to implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.|baseline (pre-implant) and 1 year follow up (post-implant)|Male - 14; Female - 3|||Intections per year||Standard Error|Mean
2845408|NCT00116337|Primary|Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.|Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).|baseline (pre-implant) and 1 year follow up (post-implant)|Male - 17; Female - 3|||L/s||Standard Error|Mean
2845409|NCT00116337|Primary|Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.|Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).|baseline (pre-implant) and 1 year follow up (post-implant)|Male - 14; Female - 3|||cmH2O||Standard Error|Mean
2845410|NCT00116272|Secondary|Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)|"The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: Yes, Sometimes, Not Yet, with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported."|1 year after birth|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available.|||Percentage of infants|||Number
2845411|NCT00116272|Secondary|Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).|||Percentage of infants|||Number
2845412|NCT00116272|Secondary|Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).|||Percentage of infants|||Number
2845413|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
2845414|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Length|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
2845415|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Weight|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
2845416|NCT00116272|Secondary|Postnatal Head Circumference Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available|||percentile||Standard Deviation|Mean
2845417|NCT00116272|Secondary|Postnatal Length Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available|||percentile||Standard Deviation|Mean
2845418|NCT00116272|Secondary|Postnatal Weight Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available|||percentile||Standard Deviation|Mean
2845419|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Head Circumference|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
2845420|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Length|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
2845421|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Weight|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.|||percentage of infants|||Number
2845422|NCT00116272|Secondary|Birth Head Circumference Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available|||cm||Standard Deviation|Mean
2845423|NCT00116272|Secondary|Birth Length Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available|||cm||Standard Deviation|Mean
2845424|NCT00116272|Secondary|Birth Weight Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available|||g||Standard Deviation|Mean
2845425|NCT00116272|Secondary|Gestational Age at Delivery (GAD) of Live Births||At birth|Live births in women enrolled and exposed to etanercept prior to 37 weeks’ gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), excluding multiple births.|||weeks||Standard Deviation|Mean
2845788|NCT00113425|Primary|Change From Baseline in Pustule Acne Lesions at Week 10||Baseline and Week 10||||pustule acne lesions||95% Confidence Interval|Mean
2845426|NCT00116272|Secondary|Percentage of Participants With Pre-term Delivery|A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks' gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.|9 months|Participants enrolled and exposed to etanercept prior to 37 weeks gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), and excluding multiple births.|||percentage of participants||95% Confidence Interval|Number
2845427|NCT00116272|Secondary|Percentage of Pregnancies Ending in Spontaneous Abortion|Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.|9 months|Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls).|||percentage of pregnancies||95% Confidence Interval|Number
2845428|NCT00116272|Secondary|Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.|From birth through 1 year of age|Children born to enrolled participants who received the dysmorphological exam. Includes multiples who received the exam for consideration of pattern; co-twins with the same 3 or more minor defects could not constitute a pattern on their own. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of infants|||Number
2845429|NCT00116272|Secondary|Percentage of Infants With Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Children born to enrolled participants during the study who received the dysmorphological exam. Includes singletons and 1 randomly selected twin from twin pairs. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of infants|||Number
2845430|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in All Pregnancies|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies counted as 1 outcome; any 1 or more malformed infant counted as 1 major malformation in the numerator and 1 outcome in the denominator. Excludes 9 lost-to-follow-up in Etanercept-Exposed and 6 in Diseased Controls cohort. Only women exposed to etanercept in 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of participants|||Number
2845431|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies ending in at least 1 live-born infant; any 1 or more malformed live-born infants counted as 1 major malformation outcome in the numerator, and 1 pregnancy outcome in the denominator. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.|||percentage of participants|||Number
2845432|NCT00116207|Secondary|Inflammation|High Sensitivity CRP (nmol/L)|24 months||||nmol/L||Standard Deviation|Mean
2845433|NCT00116207|Secondary|Systemic Oxidative Stress|ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection|24 months||||ng/G creatinine||Standard Deviation|Mean
2845434|NCT00116207|Secondary|Global Coronary Flow Reserve as a Measure of Endothelial Function|global myocardial blood flow reserve as a measure of endothelial function. Measured by PET using [13N]ammonia at rest and during adenosine stimulated coronary vasodilation.|Baseline, 24 months||||ratio (rest:stress)||Standard Deviation|Mean
2845435|NCT00116207|Primary|Global [11C]HED Retention Index (RI)|"Distal defects in [11C]meta-hydroxyephedrine ([11C]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as [11C]HEDblood min -1[ml tissue]-1~PET Data of Randomized Subjects at Baseline and 24-Months~The primary outcome was the change in the global [11C]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo."|Baseline, 24 months||||Retention index||Standard Deviation|Mean
2845436|NCT00116168|Secondary|Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)|Vz/F of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Liters||Standard Deviation|Mean
2845437|NCT00116168|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Days||Standard Deviation|Mean
2845438|NCT00116168|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Liter per day||Standard Deviation|Mean
2845569|NCT00114634|Secondary|ABC Inappropriate Behavior Sub-scale|ABC Subscale V (Inappropriate speech) has 4 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 12.|2 weeks||||units on a scale||Standard Error|Mean
2845439|NCT00116168|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Percent||Standard Deviation|Mean
2845440|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528|AUC(0-infinity) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Microgram times day per milliliter||Standard Deviation|Mean
2845441|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Micrograms times day per milliliter||Standard Deviation|Mean
2845442|NCT00116168|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Micrograms per milliliter||Standard Deviation|Mean
2845443|NCT00116168|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.|||Days||Standard Deviation|Mean
2845444|NCT00116168|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 14, 28, 42, and 84|All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)|||Participants|||Number
2845445|NCT00116168|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
2845446|NCT00116168|Primary|Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain|Number of participants with changes from baseline in the Day 28 MRI of the brain|Days 0 and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
2845447|NCT00116168|Primary|Incidence of Clinically Significant Changes From Baseline in Neurologic Exam|Number of participants with clinically significant changes from baseline in neurologic exam|Days 0, 7, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
2845448|NCT00116168|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 1, 7, 14, and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
2845449|NCT00116168|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)|||Participants|||Number
2845450|NCT00115934|Secondary|Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Stage II Discharge to 14 Months of Age, an average of 8.9 months|These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.|||complications|||Number
2845451|NCT00115934|Secondary|Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Norwood Discharge to Stage II discharge, an average of 4.2 months|These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.|||complications|||Number
2845452|NCT00115934|Secondary|Complications: Total Number Experienced During Norwood Hospitalization|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|Norwood Hospitalization, an average of 36 days||||complications|||Number
2845570|NCT00114634|Secondary|ABC Stereotypy Sub-scale|ABC Subscale III (Stereotypy) has 7 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 21.|2 weeks||||units on a scale||Standard Error|Mean
2845453|NCT00115934|Secondary|Unintended Cardiovascular Interventional Procedures|Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.|From Randomization to 12 months||||procedures|||Number
2845454|NCT00115934|Secondary|Angiographic Findings: Right Pulmonary Artery Size|Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.|||mm||Standard Deviation|Mean
2845455|NCT00115934|Secondary|Angiographic Findings: Left Pulmonary Artery Size|Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.|||mm||Standard Deviation|Mean
2845456|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||Percentage of RV end-diastolic volume||Standard Deviation|Mean
2845457|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||Percentage of RV end-diastolic volume||Standard Deviation|Mean
2845458|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes used to calculate the ejection fraction.|||Percentage of RV end-diastolic volume||Standard Deviation|Mean
2845459|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
2845460|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
2845461|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
2845462|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
2845463|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
2845510|NCT00115349|Primary|Change in Left Ventricular Ejection Fraction (LVEF).|The primary outcome variable is change in left ventricular ejection fraction (blood ejected from the heart into the body) as measured by MRI from baseline to one year. The unit of primary outcome (left ventricular ejection fraction) is the percent of the blood in left ventricle.|Baseline to one year||||Percent of the blood in left ventricle||Standard Error|Least Squares Mean
2845464|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or measures were not able to be obtained to calculate the volumes.|||ml/m^2.6||Inter-Quartile Range|Median
2845465|NCT00115934|Secondary|Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial|This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.|From Randomization to the End of the Trial, an average of 32 months||||Participants|||Number
2845466|NCT00115934|Primary|Proportion of Patients Who Died or Received a Heart Transplant|The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.|Measured at 12 months|555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.|||Participants|||Number
2845467|NCT00115869|Primary|Whether or Not Smoking Daily at 2 Years After High School|"Response (from the 2-years-after-high school questionnaire) Daily: 1 to 10 cigarettes a day, Daily: 11 to 20 cigarettes a day, Daily: more than a pack a day to the Item How often do you currently smoke cigarettes?"|2 years after high school||||participants|||Number
2845468|NCT00115869|Primary|Number of Participants Smoking Daily at 12th Grade|"Response 1 to 3 cigarettes per day, 4 to 10 cigarettes per day, 11 to 20 cigarettes per day, or More than 20 cigarettes per day to the Item How often do you currently smoke cigarettes?"|12th grade||||participants|||Number
2845469|NCT00115804|Secondary|Fibromyalgia Impact Questionnaire Modified for Children|A 19 item self-report instrument that measures overall impact of fibromyalgia including assessments of function, pain, fatigue, sleep quality, stiffness, anxiety and depression. Score range from 0 (no impact) to 100 (severe impact).|Over the past week.||||units on a scale||Standard Deviation|Mean
2845470|NCT00115804|Secondary|Multidimensional Anxiety Scale for Children|A 39-item self-report inventory that assesses four areas of anxiety symptoms (emotional, cognitive, physical, and behavioral). Score ranges from 0 (no anxiety symptoms) to 117 (severe anxiety symptoms).|Over the past week.||||units on a scale||Standard Deviation|Mean
2845471|NCT00115804|Secondary|Children's Depression Inventory|A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.|Over the past 2 weeks.||||units on a scale||Standard Deviation|Mean
2845472|NCT00115804|Secondary|The Functional Disability Inventory-parent Version|Consists of the same 15 items as the child version but allows the parent to provide their perception of the child's difficulty in performing daily physical, social, and recreational activities. The score ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."||||units on a scale||Standard Deviation|Mean
2845473|NCT00115804|Secondary|The Functional Disability Inventory-child Version|A self-report inventory that assesses patients' ability to perform a variety of daily physical, social, and recreational activities. The scale ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."||||units on a scale||Standard Deviation|Mean
2845474|NCT00115804|Secondary|The Patient Global Impression of Improvement|Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).|since baseline, at the time of the assessment||||units on a scale||Standard Deviation|Mean
2845475|NCT00115804|Secondary|The Clinical Global Impression of Severity|Measures severity of illness at the time of the assessment on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).|at the time of the assessment||||units on a scale||Standard Deviation|Mean
2845476|NCT00115804|Primary|Average Pain Severity Score|"The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale.~(0=no pain and 100 = severe pain )"|Daily on average in the past week.|6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).|||mm||Standard Deviation|Mean
2845477|NCT00115778|Secondary|Number of Lymphocytic Bronchiolitis|This is to measure the effect of IVIG on lung function.|3 months||||Instances of bronchiolitis|||Number
2845478|NCT00115778|Secondary|Number of Clinically Diagnosed Fungal Infection|This is to measure the effect of IVIG on fungal infections.|3 months||||Infections|||Number
2845479|NCT00115778|Secondary|Number of Antibiotic Initiation|This is to measure the effect of IVIG on the use of antibiotics.|3 month||||Uses of antibiotics|||Number
2845480|NCT00115778|Secondary|Number of Hospital Admissions|This is to measure the effect of IVIG on hospitalizations.|3 month||||Admissions|||Number
2845481|NCT00115778|Secondary|Number of Clinically Diagnosed Viral Infections|This is to measure the effect of IVIG on viral infections.|3 month||||Number of Infections|||Number
2845482|NCT00115778|Primary|Number of Clinically Diagnosed Bacterial Infections During the Treatment Period|The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.|3 month|The crossover design, in which each subject serves as his or her own control, allows sufficient power for the detection of a clinically significant effect of IVIG with only a small number of patients. A sample size of 10 patients in a crossover trial has more power to detect differences than double the sample size using a parallel design.|||Infections|||Number
2845483|NCT00115765|Secondary|Time to Treatment Failure (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845484|NCT00115765|Secondary|Time to Progression (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845486|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Mutant KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with irinotecan|||Participant|||Number
2845487|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Wild-type KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with irinotecan|||Participant|||Number
2845488|NCT00115765|Post-Hoc|Overall Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median.|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin|||Participant|||Number
2845489|NCT00115765|Post-Hoc|Overall Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin|||Participant|||Number
2845490|NCT00115765|Post-Hoc|Progression-free Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin|||Month||95% Confidence Interval|Median
2845491|NCT00115765|Post-Hoc|Progression-free Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin|||Month||95% Confidence Interval|Median
2845492|NCT00115765|Secondary|Progression-free Survival (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845493|NCT00115765|Secondary|Overall Survival (Irinotecan)|Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.|Overall study|Intention-to-Treat|||Participant|||Number
2845494|NCT00115765|Primary|Objective Tumor Response Through Week 12 (Irinotecan)|Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum|Overall Study|Intention-to-Treat|||Participant|||Number
2845495|NCT00115765|Secondary|Time to Treatment Failure (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.|Overall study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845496|NCT00115765|Secondary|Time to Progression (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum|Overall Study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845497|NCT00115765|Secondary|Objective Tumor Response Rate (Oxaliplatin)|Best overall response of complete or partial response within oxaliplatin stratum|Overall study|Intention-to-Treat|||Participant|||Number
2845498|NCT00115765|Secondary|Overall Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin|Overall study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845499|NCT00115765|Primary|Progression-Free Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall study|Intention-to-Treat|||Month||95% Confidence Interval|Median
2845500|NCT00115739|Secondary|6 Month Survival Rate|The percentage of patients still alive at 6 months was estimated.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.|||percentage of patients||95% Confidence Interval|Number
2845501|NCT00115739|Secondary|6 Month Progression Free Survival Rate|The percentage of patients with 6 months progression-free survival was estimated. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, the appearance of new lesions, or the significant clinical deterioration related to progression of patient's disease.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.|||percentage of patients||95% Confidence Interval|Number
2845502|NCT00115739|Secondary|Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec|Number of grade 3, grade 4 and grade 5 toxicities experienced by patients with anaplastic thyroid cancer who are treated with Gleevec.|Up to 30 days post treatment|Patients receiving at least one dose of imatinib were included in toxicity analysis.|||events|||Number
2845503|NCT00115739|Primary|Overall Response (Complete and Partial Response) Rate at 8 Weeks|The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.|8 weeks|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.|||participants|||Number
2845504|NCT00115349|Secondary|Adverse Events||continous|||||||
2845514|NCT00115063|Secondary|Change in Duke Activity Status Index (DASI) Questionnaire Score|The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.|Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||units on a scale||Standard Error|Mean
2845515|NCT00115063|Secondary|Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||mg/dL||Standard Error|Mean
2845516|NCT00115063|Secondary|Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||Percent change||Standard Error|Mean
2845517|NCT00115063|Secondary|Change in Blood Pressure||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||millimeter of mercury (mm Hg)||Standard Error|Mean
2845518|NCT00115063|Secondary|Change in Weight From Baseline in Kilograms (kg)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||kg||Standard Error|Mean
2845519|NCT00115063|Primary|Percent Change From Baseline Weight||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.|||Percent change||Standard Error|Mean
2845520|NCT00115037|Primary|Percentage of Heavy Drinking Days|Percentage of days with heavy drinking, where heavy drinking is 4 (5) or more drinks for females (males) in a 24 hour period.|16 weeks||||percentage days of heavy drinking||Inter-Quartile Range|Median
2845521|NCT00115037|Primary|Count of Responders and Non-responders in Phase 1|This is the number of patients who responded to phase 1 treatment based on the definition that subjects were randomly assigned to.|8 weeks||||Participants|||Count of Participants
2845522|NCT00114972|Secondary|The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)||5 Years|||||||
2845523|NCT00114972|Secondary|Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation||1 year, 3 and 5 years post allocation|||||||
2845524|NCT00114972|Secondary|Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation||1 month after procedure and 6 months, 1, 3 and 5 years post allocation|||||||
2845525|NCT00114972|Secondary|Freedom From MACCE and Its Components at 5 Years Post-allocation||5 years post allocation|||||||
2845526|NCT00114972|Primary|Repeat Revascularization (PCI and/or CABG).|Number of participants with repeat revascularization (PCI and/or CABG).|12 Months post enrollment||||Participants|||Number
2845527|NCT00114972|Secondary|Freedom From MACCE and Its Components at 3 Years Post-allocation||3 years post allocation|||||||
2845528|NCT00114972|Secondary|Freedom From MACCE and Its Components at 1 Year Post-allocation.|Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).|1 year post allocation||||participants|||Number
2845529|NCT00114972|Secondary|Individual Components of MACCE at 1 Year Post-allocation.|Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 year post allocation|ITT analysis|||participants|||Number
2845530|NCT00114972|Secondary|Individual Components of MACCE at 6 Months Post-allocation.|Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|6 months post allocation|ITT analysis|||Participants|||Number
2845531|NCT00114972|Secondary|Individual Components of MACCE at 1 Month Post-procedure.|Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 month after procedure|ITT analysis|||participants|||Number
2845532|NCT00114972|Secondary|Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.|Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.|1 month after procedure and 6 months, 3 years, and 5 years post allocation||||participants|||Number
2845533|NCT00114972|Primary|12-month Composite Safety Endpoint.|Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.|12 months after enrollment||||participants|||Number
2845534|NCT00114972|Primary|Primary Clinical Endpoint of 12-Month Binary MACCE.|Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).|12 months post enrollment|ITT analysis. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.|||participants|||Number
2845535|NCT00114959|Secondary|Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome|"Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:~No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%"|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.||||||
2845571|NCT00114634|Secondary|ABC Lethargy Sub-scale|ABC Subscale II (Lethargy) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree,2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48.|2 weeks||||units on a scale||Standard Error|Mean
2845789|NCT00113425|Primary|Change From Baseline in Papule Acne Lesions at Week 10||Baseline and Week 10||||papule acne lesions||95% Confidence Interval|Mean
2845536|NCT00114959|Primary|Number of Participants With Adverse Experiences (AEs)|"Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.~A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:~Results in death;~Is life threatening;~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Is medically important.~The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related."|up to 3 years|All treated participants|||participants|||Number
2845537|NCT00114959|Primary|Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.~A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells < 10*10^9/L, absolute neutrophil count >=1*10^9/L, platelets >=100*10^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.||||||
2845538|NCT00114959|Primary|Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants in accelerated or blast phase who converted to at least CML-chronic phase.~CML in accelerated phase meets one or more of the following criteria: >=15% - <30% blasts in peripheral blood or bone marrow, >=30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood; platelet count <100*10^9/L unrelated to therapy or clonal evolution. CML in blast phase have >=30% blasts in the bone marrow or presence of extramedullary disease.~Meaningful responses include (in descending order of health)~Complete Hematologic Remission (CHR)~Partial Hematologic Remission (PHR)~Hematologic Improvement (HI)~Partial Response (PR)~Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts <15%, peripheral blasts and promyelocytes <30%, peripheral basophils <20%, and platelets >100*10^9/L."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.||||||
2845539|NCT00114777|Secondary|Percentage of Participants With Graft Loss or Death to Month 84|Participant and graft survival at 84 months was summarized within each treatment group.|Randomization to date of death, up to 84 months|All randomized and transplanted participants|||percentage of participants|||Number
2845540|NCT00114777|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Month 84|All randomized and transplanted participants who completed 36 months of treatment and continued into long-term extension phase|||participants|||Number
2845541|NCT00114777|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Day 1 to Month 36|All randomized and transplanted participants|||participants|||Number
2845542|NCT00114777|Secondary|Number of Participants With Laboratory Test Abnormalities up to 36 Months|Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.|Day 1 to Month 36|All randomized and transplanted participants.|||participants|||Number
2845543|NCT00114777|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months|Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.|Day 1 to Month 36|All randomized and transplanted participants|||participants|||Number
2845544|NCT00114777|Secondary|Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36|The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.|Baseline and Months 12, 24 and 36|Randomized and transplanted participants|||units on SF-36 scale||Standard Error|Mean
2845790|NCT00113399|Primary|Overall Survival||Date of death or last follow-up|This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.||||||
2845545|NCT00114777|Secondary|Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants|||participants|||Number
2845546|NCT00114777|Secondary|Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte -depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte -depletion therapy.|Months 6, 12, 24 and 36|All randomized and transplanted participants|||participants|||Number
2845547|NCT00114777|Secondary|Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84|Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845548|NCT00114777|Secondary|Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36|Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||mg/dL||Standard Deviation|Mean
2845549|NCT00114777|Secondary|Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months|Dyslipidemia was defined as triglyceride ≥ 500 mg/dL [5.65 mmol/L], low density lipoprotein (LDL) ≥ 100 mg/dL [2.59 mmol/L], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL [3.36 mmol/L]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845550|NCT00114777|Secondary|Mean Framingham Risk Score From Baseline to Months 12, 24 and 36|The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from <-3 to >14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.|Baseline and Months 12, 24 and 36|All randomized and transplanted participants|||units on a scale||Standard Deviation|Mean
2845551|NCT00114777|Secondary|Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||mmHg||Standard Deviation|Mean
2845552|NCT00114777|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.|NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).|Months 12, 24 and 36|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845553|NCT00114777|Secondary|Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 12, 24 and 36|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845554|NCT00114777|Secondary|Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months|Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Baseline and Months 12, 24 and 36|All randomized and transplanted participants|||participants|||Number
2845555|NCT00114777|Secondary|Change in Calculated GFR at Months 12, 24, 36 and 84|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Baseline and Months 12, 24, 36 and 84|All randomized and transplanted participants|||mL/min/1.73 m^2||Standard Deviation|Mean
2845556|NCT00114777|Secondary|Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|Months 6, 12, 24, 36 and 84|All randomized and transplanted participants|||participants||Standard Deviation|Mean
2845557|NCT00114777|Secondary|Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant|Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.|Month 24 and Month 36 post-transplant|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845558|NCT00114777|Secondary|Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12|Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.|At Month 12|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845559|NCT00114777|Secondary|Measured Glomerular Filtration Rate (GFR) by Month 12 and 24|GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, 'n' signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.|At Month 12 and Month 24|All randomized and transplanted participants|||mL/min/1.73 m^2||Standard Deviation|Mean
2845560|NCT00114777|Primary|Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12|GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.|From Month 3 to Month 12|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845561|NCT00114777|Primary|Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant|Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.|Month 12 post-transplant|All randomized and transplanted participants|||percentage of participants||95% Confidence Interval|Number
2845562|NCT00114738|Secondary|Clinical Response|Clinical response is assessed by the response criteria for lymphomas and is defined as a fraction of patients who have a complete response (CR) or a complete response (CR) + partial response (PR). A complete response is disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g. lactate dehydrogenase) definitely assignable to the lymphoma. Partial response is ≥50% decreased in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen, ≥50% increase in the absolute number of circulating lymphocytes.|up to 22 weeks after initiation of therapy|Participants are grouped together in one arm/group because this is the arm/group in which all participants received drug.|||Percentage of patients|||Number
2845563|NCT00114738|Secondary|Count of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 143 months and 7 days|Participants are grouped together in one arm/group because most adverse events occurred during Part B, in which all participants received drug.|||Participants|||Count of Participants
2845564|NCT00114738|Primary|Overall Survival|Overall Survival is the time between the first day of treatment to the day of death. The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test.|up to 9.9 years||||Months||95% Confidence Interval|Median
2845565|NCT00114738|Primary|Overall Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression. Progression is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes, appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, appearance of new palpable hepatomegaly or splenomegaly that was not previously present, and ≥50% increase in the absolute number of circulating lymphocytes.|up to 9.9 years||||Months||95% Confidence Interval|Median
2845566|NCT00114738|Primary|Median Overall Survival (OS)|Overall Survival is the time between the first day of treatment to the day of death. The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test.|up to 9.9 years||||Months||95% Confidence Interval|Median
2845567|NCT00114738|Primary|Progression Free Survival (PFS)|Time interval from start of treatment to documented evidence of disease progression. Progression is defined by at least one of the following: ≥50% increase in the sum of the products of at least two lymph nodes, appearance of new lymph nodes, ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, appearance of new palpable hepatomegaly or splenomegaly that was not previously present, and ≥50% increase in the absolute number of circulating lymphocytes.The primary evaluation will be a Kaplan-Meier analysis with a two tailed log rank test.|up to 5 years||||Months||95% Confidence Interval|Median
2848321|NCT00094900|Secondary|Mean Change in C-Reactive Protein||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
2845572|NCT00114634|Secondary|ABC Irritability Sub-scale|ABC Subscale I (Irritability) has 15 items, each can be rated from 0 to 3, with 0 equal to not at all a problem, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 45|2 weeks||||units on a scale||Standard Error|Mean
2845573|NCT00114634|Primary|Hyperactivity Sub-scale of the Aberrant Behavior Checklist-Community (ABC-C).|The Aberrant Behavior Checklist-Community (ABC-C) is a measure used to identify treatment efficacy among intellectually impaired individuals. ABC Subscale IV (Hyperactivity) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, one the problem is the behavior but slight in degree, to the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48. The higher the score, the worse the hyperactivity. The comparison in this study was made between the blinded phases when patients received either egg yolk (treated, +cholesterol) or egg substitute (untreated, -cholesterol). Order was randomized.|2 weeks||||units on a scale||Standard Error|Mean
2845574|NCT00114530|Secondary|Time to Absolute Neutrophil Count Engraftment|Time to absolute neutrophil count (ANC) engraftment is defined as the number of days post-transplant until required levels of ANC are attained (for the mHSCT arm only). If engraftment did not occur within 28 days post-transplant, then the variable was set to 28 days. ANC engraftment required an ANC of > 500 cells/microliter, maintained for 3 consecutive days.|28 days post-transplant|Per-protocol (PP) – mHSCT arm only. The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm.|||Days||Full Range|Median
2845575|NCT00114530|Secondary|Number of Subjects With Infectious Complications|"Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of Infections and infestations or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections."|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Participants|||Count of Participants
2845576|NCT00114530|Secondary|Infectious Complications|"Infectious complications include any events that code to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class of Infections and infestations or events that a site has classified as an infectious event. These can include bacteremia, septicemia, fungemia, fever associated with infection, infectious pneumonia, idiopathic pneumonia syndrome, clinical infection (i.e. infection diagnosed with clinical features without identification of an organism) and other local/organ site-specific infections."|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Events|||Number
2845577|NCT00114530|Secondary|Number of Subjects With Regimen-Related Toxicities|Regimen-related toxicities are defined as Grade 3 or higher adverse events reported by site physicians as possibly, probably, or definitely related to study therapy.|Randomization through end of study follow-up (up to Month 72 post-randomization).|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Participants|||Count of Participants
2845578|NCT00114530|Secondary|Regimen-Related Toxicities|Regimen-related toxicities are defined as Grade 3 or higher adverse events reported by site physicians as possibly, probably, or definitely related to study therapy.|Randomization through end of study follow-up (up to Month 72 post-randomization)|Safety population. The safety population includes all participants for whom study treatment was initiated. For the mHSCT arm, treatment was initiated with the first dose of granulocyte colony stimulating factor for mobilization, and for the cyclophosphamide arm, treatment was initiated with the first dose of IV cyclophosphamide.|||Events|||Number
2845579|NCT00114530|Secondary|Initiating Use of Disease-Modifying Antirheumatic Drugs by Month 54 (DMARDs) (PP)|Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845580|NCT00114530|Secondary|Initiating Use of Disease-Modifying Antirheumatic Drugs (DMARDs) by Month 54 (ITT)|Initiation of disease-modifying antirheumatic drugs (DMARDs). Participants were not expected to receive additional disease-modifying therapy for systemic sclerosis (SSc) in the absence of disease progression. In general, this includes the administration of any therapy clearly given for the purpose of treating the underlying SSc. It does not include concomitant treatments permitted in the protocol, such as use of methotrexate (15 g or less), anti-malarials, or minocycline for arthritis only. Systemic corticosteroids given at > 10 mg/day (prednisone or prednisone equivalent), without clearly defined non-SSc indications, and methotrexate given for non-arthritis indications are examples of qualifying DMARDs.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845791|NCT00113386|Primary|Comparison of Overall Survival||Date of death or date of last follow-up|This study terminated early with 19 out of 574 subjects accrued. Therefore no analysis was performed.||||||
2845581|NCT00114530|Secondary|Documented Myositis (PP)|Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845582|NCT00114530|Secondary|Documented Myositis (ITT)|Number of participants who experienced any event of myositis that occurred from randomization to Month 54 post-randomization. Documented myositis occurred if the participant had 1) elevated creatine phosphokinase (CPK), electromyography, and/or biopsy and 2) required > 30 mg per day prednisone for over 1 month or another therapy such as methotrexate (MTX) for treatment of myositis. Additionally, any adverse event reported as myositis was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845583|NCT00114530|Secondary|Occurrence of Scleroderma Renal Crisis (PP)|Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845584|NCT00114530|Secondary|Occurrence of Scleroderma Renal Crisis (ITT)|Documented scleroderma renal crisis (hypertensive or non-hypertensive) occurring from randomization to Month 54 post-randomization was summarized. A hypertensive scleroderma renal crisis occurred if a participant obtained both of the following: New-onset hypertension, defined as systolic blood pressure (SBP) >= 140 mmHg, diastolic blood pressure (DBP) >= 90 mmHg, a rise in SBP >= 30 mmHg compared to baseline, or a rise in DBP >= 20 mmHg compared to baseline, and one of the following features: 1) increase of >= 50 % above baseline in serum creatinine, 2) proteinuria (>= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5), 3) hematuria (>= 2+ by dipstick or > 10 RBCs/HPF, without menstruation), 4) thrombocytopenia (< 100,000 plts/mm3), or 5) hemolysis (determined by blood smear or increased reticulocyte count). Additionally, any adverse event reported as a scleroderma renal crisis was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845585|NCT00114530|Secondary|New or Worsening Pulmonary Hypertension (PP)|Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization would be done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845586|NCT00114530|Secondary|New or Worsening Pulmonary Hypertension (ITT)|Any pulmonary arterial hypertension (PAH) events that occurred between randomization and Month 54 post-randomization were summarized. Development of PAH occurred if the participant met the following criteria, where the measurement value(s) could not be explained by other causes such as congestive heart failure or pulmonary emboli: 1) a post-baseline peak systolic pulmonary artery pressure > 55 mmHg by echocardiogram or 2) a mean pulmonary artery pressure > 30 mmHg at rest measured by right heart catheterization. If the post-baseline peak systolic pulmonary artery pressure was between 40 to 55 mmHg by echocardiogram, a right heart catheterization was done to confirm a diagnosis of pulmonary artery hypertension. The endpoint was met if the mean pulmonary artery pressure was > 30 mmHg at rest by right heart catheterization. Additionally, any adverse event reported as PAH was included in the analysis.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845587|NCT00114530|Secondary|New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (PP)|Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening will be defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845588|NCT00114530|Secondary|New or Worsening Arrhythmias, Congestive Heart Failure, or Pericardial Effusion (ITT)|Any events that met the criteria outlined below or were reported as adverse events between randomization and Month 54 post-randomization are summarized. 1) Development of new or worsening arrhythmias that require medical treatment for >= 3 months or require ablative therapy or pacemaker insertion. (Note that for a participant who has medically controlled arrhythmia at randomization, worsening was defined as breakthrough episodes severe enough to prompt change in medication, an increase in the dose of a medication, or addition of a new medication to maintain control of the arrhythmia.) 2) Congestive heart failure (CHF) requiring clinical treatment for >= 3 months develops. 3) Clinically significant pericardial effusion (excess fluid around the heart) that required pericardial window.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845589|NCT00114530|Secondary|Change From Baseline to Month 54 in Modified Rodnan Skin Score (mRSS) (PP)|"The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity. Analysis was based on an ordinal response variable, defined as follows: if the baseline mRSS was <=20, a decrease >=5 points from baseline indicated disease improvement and an increase >= 5 points indicated disease worsening; if the baseline mRSS was >20, then a decrease of >25% indicated disease improvement and an increase of >25% indicated disease worsening. Participants who do not meet the disease criteria outlined above were considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845590|NCT00114530|Secondary|Change From Baseline to Month 54 in Modified Rodnan Skin Score (mRSS) (ITT)|"The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity. Analysis was based on an ordinal response variable, defined as follows: if the baseline mRSS was <=20, a decrease >=5 points from baseline indicated disease improvement and an increase >= 5 points indicated disease worsening; if the baseline mRSS was >20, then a decrease of >25% indicated disease improvement and an increase of >25% indicated disease worsening. Participants who do not meet the disease criteria outlined above were considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845591|NCT00114530|Secondary|Change From Baseline to Month 54 in Forced Vital Capacity (FVC) (PP)|"Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards. Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >10% in FVC % Predicted indicated disease improvement, a decrease of >10% indicated disease worsening, and a change of <=10% was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845592|NCT00114530|Secondary|Change From Baseline to Month 54 in Forced Vital Capacity (FVC) (ITT)|"Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards. Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >10% in FVC % Predicted indicated disease improvement, a decrease of >10% indicated disease worsening, and a change of <=10% was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845593|NCT00114530|Secondary|Change From Baseline to Month 54 in Diffusion in Liters of Carbon Monoxide (DLCO) (PP)|"Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant's hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >15% in DLCO % Predicted indicated disease improvement, a decrease of >15% indicated disease worsening, and a change of <=15% was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845603|NCT00114530|Secondary|Treatment-Related Mortality (Month 48, PP)|Death, occurring at any time between randomization and Month 48 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845594|NCT00114530|Secondary|Change From Baseline to Month 54 in Diffusion in Liters of Carbon Monoxide (DLCO) (ITT)|"Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant's hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Analysis was based on an ordinal response variable, defined as follows: an increase from baseline of >15% in DLCO % Predicted indicated disease improvement, a decrease of >15% indicated disease worsening, and a change of <=15% was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845595|NCT00114530|Secondary|Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (PP)|"The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. Each component was transformed into a 0-100 scale (higher numbers indicate greater quality of life) and normalized to have a mean of 50 and standard deviation of 10 for the 1998 general US population. Analysis was based on ordinal response, defined as follows for each component: a >= 10 point increase indicated disease improvement, a >= 10 point decrease indicated disease worsening, and a change <10 points indicated no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845596|NCT00114530|Secondary|Change From Baseline to Month 54 in Short Form 36 Health Survey (SF-36) (ITT)|"The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. Each component was transformed into a 0-100 scale (higher numbers indicate greater quality of life) and normalized to have a mean of 50 and standard deviation of 10 for the 1998 general US population. Analysis was based on ordinal response, defined as follows for each component: a >= 10 point increase indicated disease improvement, a >= 10 point decrease indicated disease worsening, and a change <10 points indicated no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845597|NCT00114530|Secondary|Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (PP)|"HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845598|NCT00114530|Secondary|Change From Baseline to Month 54 in Health Assessment Questionnaire - Disability Index (HAQ-DI) (ITT)|"HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities). The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. Analysis was based on an ordinal response variable, defined as follows: a decrease of >0.4 from baseline in the HAQ-DI score was considered disease improvement, an increase of >0.4 was considered disease worsening, and any change less than 0.4 was considered no change. Data for participants without a Month 54 assessment was imputed using a last observation carried forward approach; improvement/worsening was assessed at each participant's last available study visit that occurred prior to or at Month 54, without confirmation at the next visit."|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845599|NCT00114530|Secondary|All-Cause Mortality (Month 48, PP)|Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm|||Participants|||Count of Participants
2845600|NCT00114530|Secondary|All-Cause Mortality (Month 48, ITT)|Any death, regardless of relationship to treatment, between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845601|NCT00114530|Secondary|All-Cause Mortality (Month 54, PP)|Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm|||Participants|||Count of Participants
2845602|NCT00114530|Secondary|All-Cause Mortality (Month 54, ITT)|Any death, regardless of relationship to treatment, between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845604|NCT00114530|Secondary|Treatment-Related Mortality (Month 48, ITT)|Death, occurring at any time between randomization and Month 48 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845605|NCT00114530|Secondary|Treatment-Related Mortality (Month 54, PP)|Death, occurring at any time between randomization and Month 54 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845606|NCT00114530|Secondary|Treatment-Related Mortality (Month 54, ITT)|Death, occurring at any time between randomization and Month 54 post-randomization, which is possibly, probably, or definitely resulting from treatment given in the study.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845607|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 48, PP)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845608|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 48, ITT)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 48 post-randomization.|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845609|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 54, PP)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Participants|||Count of Participants
2845610|NCT00114530|Secondary|Event-Free Survival (EFS) (Month 54, ITT)|Event-free survival (EFS) is defined as survival without significant organ damage or death. EFS failure includes any one of the following: death, respiratory failure (decrease from baseline of >30% in diffusion in liters of carbon monoxide (DLCO) % predicted or >20% in forced vital capacity (FVC) % predicted, documented on at least 2 successive occasions at least 1 month apart), renal failure (requiring chronic dialysis > 6 months or transplantation), or the occurrence of cardiomyopathy (clinical congestive heart failure or left ventricular ejection fraction <30%, documented on at least 2 successive occasions at least 1 month apart). EFS failures include participants who failed any component of the EFS definition between randomization and Month 54 post-randomization.|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Participants|||Count of Participants
2845611|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 48, PP)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|48 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Sum of subject-pair comparison scores||Full Range|Median
2845623|NCT00114231|Secondary|Local Recurrence Rate|The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.|Up to 5 years||||percentage of patients|||Number
2845792|NCT00113373|Secondary|Prognostic Variable: Cellular Histology|Number of patients with Clear Cell Carcinoma or Mucinous Carcinoma|Baseline|Eligible and evaluable patients|||Participants|||Count of Participants
2845612|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 48, ITT)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|48 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Sum of subject-pair comparison scores||Full Range|Median
2845613|NCT00114530|Secondary|Global Rank Composite Score (GRCS) (Month 54, PP)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|54 Months Post-Randomization|Per-protocol (PP). The PP population is defined as those participants who completed the assigned treatment protocol: undergoing autologous CD34-selected hematopoietic progenitor cell transplantation in the mHSCT arm, or receiving at least 9 of 12 planned doses in the cyclophosphamide arm.|||Sum of subject-pair comparison scores||Full Range|Median
2845614|NCT00114530|Primary|Global Rank Composite Score (GRCS) (Month 54, ITT)|The GRCS is an analytic tool that accounts for multiple disease manifestations simultaneously. It does not measure clinical disease activity or severity but reflects how participants compared to one another based on a hierarchy of ordered outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Health Assessment Questionnaire - Disability Index (HAQ-DI), and Modified Rodnan Skin Score (mRSS). Participants alive ranked higher than those who died; those who survived event-free ranked higher than EFS failures. EFS failure included death, respiratory failure (decrease from baseline of >30% in DLCO % predicted or >20% in FVC % predicted ), renal failure (chronic dialysis > 6 month or renal transplant), or cardiac failure (clinical congestive heart failure or left ventricular ejection fraction <30%). The lowest 3 GRCS components are ordinal; improvement, stability, or worsening from baseline (±10% change in FVC % predicted, ±0.4 change in HAQ-DI, ±25% change in mRSS).|54 Months Post-Randomization|Intention to treat (ITT). The ITT population includes all randomized participants.|||Sum of subject-pair comparison scores||Full Range|Median
2845615|NCT00114517|Secondary|Number of Participants With Coronary Artery Calcium Measured by Cardiac Computed Tomography|measurement of coronary artery calcium at end of study|End of randomized treatment|CAC data was obtained in 380 participants. Participants who were not taking the study agents at the last follow-up visit, who had adherence to the study regimen that was lower than 80% or who had a CAC scan more than 6 months after the final study visit were not included in the analysis.|||Participants|||Count of Participants
2845616|NCT00114517|Secondary|Change in Neurocognitive Function (Global Cognition)|All neuropsychological test scores at baseline and follow-up assessments were standardized ([raw score - mean score]/standard deviation) using the baseline means and standard deviations from the entire ELITE sample. Each of three cognitive composite scores was calculated at baseline and follow-up assessments as the weighted average of the individual donor standardized test scores, weighted by the inverse correlation among tests.The change from baseline (endpoint minus baseline cognitive outcome) was computed for each of the cognitive scores (verbal memory, global cognition, and executive functions). Since the outcome is not a single test but a weighted average of multiple tests, the range is not standard and not reported. Higher scores mean better outcomes.|Baseline and at 2.5 years and 5 years|Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline. Sample size represents the number of participants with analyzable data collected at baseline, 2.5 years and 5.0 years.|||units on a scale||95% Confidence Interval|Mean
2845617|NCT00114517|Primary|Rate of Change of Distal Common Carotid Artery (CCA) Far Wall Intima-media Thickness (IMT)||Twice at baseline and then every 6 months on trial|Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline.|||mm per year||95% Confidence Interval|Mean
2845618|NCT00114504|Secondary|Circulating Inflammation Marker|Change in circulating hsCRP levels|Baseline, 3 months||||mg/dL||Standard Deviation|Mean
2845619|NCT00114504|Primary|Plaque Inflammation|Change in plaque inflammation was assessed by changes in the plaque SUV.|Baseline, 3 months||||SUV||Standard Deviation|Mean
2845620|NCT00114244|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood's standard errors will be summarized by arm.|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months||||Months||95% Confidence Interval|Median
2845621|NCT00114244|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier by arm.|From first day of treatment to time of death due to any cause, assessed up to 6 months||||Months||95% Confidence Interval|Median
2845622|NCT00114244|Primary|Objective Response (OR = CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 6 weeks.||||participants|||Number
2848322|NCT00094900|Secondary|Mean Change in C-Reactive Protein||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
2845624|NCT00114231|Secondary|Rate of Pathologic Complete Response of the Primary Tumor|The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.|Up to 5 years|Patients assessable for pathology results were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2845625|NCT00114231|Secondary|Morbidity and Mortality Rate|Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.|Up to 30 days||||percentage of patients|||Number
2845626|NCT00114231|Secondary|R0 Resection Rate (Negative Margin Rate)|The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.|At time of surgery|Patients who had local excision are included in this analysis.|||percentage of patients|||Number
2845627|NCT00114231|Primary|3-Year Disease-free Survival|The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2845628|NCT00114218|Primary|Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Count of participants with Toxicities maximum grade greater than or equal to grade 3|Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and Treated patients|||Participants|||Count of Participants
2845629|NCT00114218|Primary|Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and Treated patients|||Percentage of participants||95% Confidence Interval|Number
2845630|NCT00114166|Secondary|Reason Off Study Therapy||study entry through end of study treatment, up to 5 years|Eligible and evaluable participants|||Participants|||Count of Participants
2845631|NCT00114166|Primary|Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||Participants|||Count of Participants
2845632|NCT00114166|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal|Eligible and evaluable participants|||Participants|||Count of Participants
2845633|NCT00114140|Primary|Neurocognitive Function|"Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must connect the dots either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change."|Baseline, 6 months, and 12 months.|Eligible patients entered after QOL component amendment with baseline score and alive at 6 and 12 months for respective timepoint.|||participants|||Number
2845634|NCT00114140|Primary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR)|Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%.|Baseline, 6 months, and 12 months.|Eligible patients entered after QOL component amendment and alive at 6 and 12 months for respective post-baseline endpoints.|||units on a scale||Full Range|Median
2845650|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 14 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age|||Percentage of FluMist recipients|||Number
2848323|NCT00094900|Secondary|Mean Change in C-Reactive Protein||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/dl||Standard Error|Mean
2845635|NCT00114140|Primary|Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status|"Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on clinical deterioration including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact."|Registration to 3 years|Eligible patients with O(6)-methylguanine-DNA methyltransferase (MGMT) status|||years||95% Confidence Interval|Median
2845636|NCT00114140|Primary|Progression-free Survival|"Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on clinical deterioration including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported."|From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years.|Eligible patients|||years||95% Confidence Interval|Median
2845637|NCT00114140|Primary|Overall Survival Rate at 3 Years|Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years.|Registration to 3 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2845638|NCT00114127|Secondary|CGI-S|"The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6."|6 months||||Scores on a scale||Standard Error|Mean
2845639|NCT00114127|Primary|Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.|6 months||||Scores on a scale||Standard Error|Mean
2845640|NCT00114114|Secondary|Change in Libido / Sexual Desire|Change in libido from baseline (scale ranges from -2 to +2), with -2 being much less, -1 somewhat less, 0 same, +1 somewhat more, +2 much more|16 weeks||||units on a scale||Standard Error|Mean
2845641|NCT00114114|Secondary|Change in Erectile Function Symptoms|Based on International Index of Erectile Function (IIEF) scale, question #15, which asked subjects to rate their confidence that they could achieve and maintain an erection. Scores range from 1 to 5, with higher scores being better.|Baseline and 16 weeks||||units on a scale||Standard Error|Mean
2845642|NCT00114114|Secondary|Percentage Change in Thigh Muscle Area|Assessed by quantitative computed tomography (QCT)|Baseline and 16 weeks||||percentage change||Standard Error|Mean
2845643|NCT00114114|Secondary|Percentage Change in Body Composition: Fat Mass||Baseline and 16 weeks||||Percentage change||Standard Error|Mean
2845644|NCT00114114|Primary|Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)||Baseline and 16 weeks||||percentage change||Standard Error|Mean
2845645|NCT00114101|Post-Hoc|Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy|Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.|Duration of study (up to 10 years)||||participants|||Number
2845646|NCT00114101|Other Pre-specified|Overall Survival|Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
2845647|NCT00114101|Secondary|Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100|"Response was defined according to International Myeloma Working Group criteria (2006)~Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels~Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour~Progressive Disease: Defined in primary outcome measure~Stable Disease: Not meeting any of the criteria above"|Day 100||||participants|||Number
2845648|NCT00114101|Primary|Time to Progression|"Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.~Progression was defined per the International Myeloma Working Group definition as one more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas~Development of hypercalcemia"|Duration of study (up to 10years)||||months||95% Confidence Interval|Median
2845649|NCT00113919|Primary|Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients|maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min|three years|||||||
2848324|NCT00094900|Secondary|Mean Change in Serum Amyloid A||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
2845652|NCT00113880|Secondary|Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls|Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.|180 days|Analyses were performed by period (180 days) and age group (5-8, 9-17, 18-49 years of age), post Dose 1. recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance was observed for any hospitalization or death, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
2845653|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
2845654|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
2845655|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
2845656|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
2845657|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.|21 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.|||Cases per 1,000 person-months|Participants||Number
2845658|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospital/death setting 180 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
2845659|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospitalization/death setting, 180 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
2845678|NCT00113763|Secondary|Duration of Response|Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.|||weeks||95% Confidence Interval|Median
2845660|NCT00113880|Primary|Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
2845661|NCT00113880|Primary|Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.|||Cases per 1,000 person-months|Participants||Number
2845662|NCT00113880|Primary|Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). significance was observed for encephalitis/encephalopathy, for all age groups, across all settings within 42 days, PD1.|||Cases per 1,000 person-months|Participants||Number
2845663|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/RAD, wheezing/shortness of breath (SOB), and any ashtma or wheezing event across all settings, PD1 (all age groups) and PD2.|||Cases per 1,000 person-months|Participants||Number
2845664|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/reactive airway disease (RAD) and any ashtma or wheezing event across all settings, PD1 (all ages and 9-17 yrs) and PD2 (5-8 yrs).|||Cases per 1,000 person-months|Participants||Number
2845665|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days and 42 days (all age groups) and post Dose 2 (PD2) within 42 days (5-8 yrs).|||Cases per 1,000 person-months|Participants||Number
2845666|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days for within cohort and within 42 days for unvaccinated.|||Cases per 1,000 person-months|Participants||Number
2845667|NCT00113880|Primary|Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.|There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).|||Cases per 1,000 person-months|Participants||Number
2845668|NCT00113880|Primary|Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.|3 days|Analyses were performed by period (3 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).|||Cases per 1,000 person-months|Participants||Number
2845690|NCT00113568|Primary|Number of Subjects With Adverse Events That Led to Discontinuation From the Study|The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator|Up to 27 menstrual cycles||||participants|||Number
2845669|NCT00113880|Primary|Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.|21 and 42 days|Analyses performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (1 or 2 for ages 5-8 years). Significance observed in the clinic, 21 days post Dose 1 in 1 subj. (heart murmur, all ages combined); 18 and 19 subj.(pregnancy exam, 18-49 and all ages combined).|||Cases per 1,000 person-months|Participants||Number
2845670|NCT00113880|Primary|Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the clinic setting, 21 days post Dose 1 in 7 subjects (breast lump/cyst, 9-17 yrs) and in 22 subjects (mastitis, 18-49 yrs).|||Cases per 1,000 person-months|Participants||Number
2845671|NCT00113841|Primary|Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment|Percent change of NF-kB =[(expression at 4 weeks- expression at baseline)/expression at baseline]*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.|Baseline through 4 weeks of treatment|All participants in the two arms (Curcumin versus Curcumin plus Bioperine) who received at least 4 weeks of treatment were eligible for outcome evaluation.|||Percent reduction||Standard Deviation|Mean
2845672|NCT00113763|Post-Hoc|Progression-free Survival Time (Mutant KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group.|Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||weeks||95% Confidence Interval|Median
2845673|NCT00113763|Post-Hoc|Progression-free Survival Time (Wild-type KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with wild-type KRAS was 36.8 weeks in the panitumumab plus BSC group and 35.7 weeks in the BSC alone group.|Wild-type KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.|||weeks||95% Confidence Interval|Median
2845674|NCT00113763|Secondary|Duration of Stable Disease|Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Participants who had a best overall response of stable disease|||weeks||95% Confidence Interval|Median
2845675|NCT00113763|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)|||weeks||95% Confidence Interval|Median
2845676|NCT00113763|Secondary|Time to Disease Progression|Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat|||weeks||95% Confidence Interval|Median
2845677|NCT00113763|Secondary|Time to Response|Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.|||weeks||Inter-Quartile Range|Median
2845691|NCT00113568|Primary|Number of Subjects With at Least One Life-Threatening Adverse Event During the Study|A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2845679|NCT00113763|Secondary|Objective Tumor Response|Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)|||participants|||Number
2845680|NCT00113763|Secondary|Overall Survival|Kaplan-Meier estimates of median time from randomization to death.|From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group.|Intention-to-treat (ITT)|||months||95% Confidence Interval|Median
2845681|NCT00113763|Primary|Progression-free Survival Time|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.|Intention-to-treat (ITT)|||weeks||95% Confidence Interval|Median
2845682|NCT00113607|Secondary|Median Maximum Plasma Concentration (Cmax) of Trabectedin.|Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.|||pg/mL|||Number
2845683|NCT00113607|Secondary|Median Area Under Curve (AUC) of Trabectedin.|Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.|||ng*h/mL|||Number
2845684|NCT00113607|Secondary|Duration of Response: Independent Radiologist Review|Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.|From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years|All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.|||Months||95% Confidence Interval|Median
2845685|NCT00113607|Secondary|Objective Response Rate (ORR) - Independent Radiologist Review|Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.|||Percentage of participants|||Number
2845686|NCT00113607|Secondary|Overall Survival|Overall survival was defined as the time between the randomization and death|From the date of randomization until the date of death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not|||Months||95% Confidence Interval|Median
2845687|NCT00113607|Primary|Progression-Free Survival (PFS): Independent Radiologist Review|PFS is defined as the time between randomization and disease progression or death.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.|||Months||95% Confidence Interval|Median
2845688|NCT00113568|Primary|Number of Subjects Who Died During the Study|Number of subjects who died, for any reason, during the study|Up to 27 menstrual cycles||||participants|||Number
2845689|NCT00113568|Primary|Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study|Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2848325|NCT00094900|Secondary|Mean Change in Serum Amyloid A||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
2845692|NCT00113568|Primary|Number of Subjects With at Least One Serious Adverse Event During the Study|A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2845693|NCT00113568|Primary|Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2845694|NCT00113568|Primary|Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2845695|NCT00113568|Primary|Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2845696|NCT00113568|Primary|Number of Subjects With at Least One Adverse Event During the Study|An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.|Up to 27 menstrual cycles|intent to treat population|||participants|||Number
2845697|NCT00113555|Secondary|Provocative Pad Weight|Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.|Baseline to 12 months|Intent to Treat|||gm||Standard Deviation|Mean
2845698|NCT00113555|Secondary|Number of Pads Changed Per Day (Voiding Diary)|Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.|Baseline to 12 months|Intent to Treat|||Number of Pads Changed per Day||Standard Deviation|Mean
2845699|NCT00113555|Secondary|Number of Incontinence Episodes Per Day (Voiding Diary)|Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
2845700|NCT00113555|Secondary|Urinary Distress Inventory (UDI-6)|Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
2845701|NCT00113555|Secondary|Incontinence Impact Questionnaire (IIQ-7)|Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
2845702|NCT00113555|Secondary|Incontinence Quality of Life (IQoL) Questionnaire|Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.|Baseline to 12 months|Intent to Treat|||units on a scale||Standard Deviation|Mean
2845703|NCT00113555|Primary|Change of Stamey Grade From Baseline to 12 Months.|"The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed.~The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1."|Baseline to 12 months|Intent to Treat|||units on a scale||95% Confidence Interval|Mean
2845704|NCT00113529|Secondary|Ctrough of Gefitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.|||ng/mL||Standard Deviation|Mean
2845705|NCT00113529|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.|||ng/mL||Standard Deviation|Mean
2845706|NCT00113529|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|Pharmacokinetic (PK) = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.|||ng/mL||Standard Deviation|Mean
2845707|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845772|NCT00113490|Secondary|Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations|Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.|||participants|||Number
2845708|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845709|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845710|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845711|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845712|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845713|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845714|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845715|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845716|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845773|NCT00113490|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Assessments of SAEs were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.|||participants|||Number
2845774|NCT00113490|Secondary|Number of Subjects Reporting Adverse Events (AEs)|Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.|||participants|||Number
2845717|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845718|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||pg/mL|||Number
2845719|NCT00113529|Secondary|sVEGFR3 Ratio to Baseline at Each Time Point|sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
2845720|NCT00113529|Secondary|Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline|Concentration of sVEGFR3 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
2845721|NCT00113529|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
2845722|NCT00113529|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline|Concentration of sVEGFR2 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
2845723|NCT00113529|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
2845724|NCT00113529|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
2845725|NCT00113529|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
2845726|NCT00113529|Secondary|VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline|Concentration of VEGF at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.|||pg/mL||Standard Deviation|Mean
2845727|NCT00113529|Secondary|Probability of Survival at One Year|Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year|ITT|||probability|||Number
2845728|NCT00113529|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death|ITT. Number of participants analyzed = those who progressed or died due to any cause while on study.|||weeks||95% Confidence Interval|Median
2845729|NCT00113529|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.|From start of study treatment until death|ITT. Number of participants analyzed = subjects who died.|||weeks||Full Range|Median
2845730|NCT00113529|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who progressed on study.|||weeks||95% Confidence Interval|Median
2845731|NCT00113529|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer|ITT. Number of participants analyzed = those who had a response and subsequent progression or death due to any cause while on study.|||weeks||Full Range|Median
2845732|NCT00113529|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who had a confirmed response on study.|||weeks||95% Confidence Interval|Median
2845733|NCT00113529|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|Intent-to-treat (ITT) = all subjects enrolled in the study that received at least 1 dose of study medication (sunitinib or gefitinib).|||participants|||Number
2845734|NCT00113516|Secondary|Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)|QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.|||scores on a scale||Standard Error|Mean
2845735|NCT00113516|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.|||scores on a scale||Standard Error|Mean
2845736|NCT00113516|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib|A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.|Within 7 days of Day 1|c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient.|||pg/mL|||Number
2845737|NCT00113516|Secondary|Immunohistochemical Staining of Paraffin Embedded Tumor Tissue|Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.|Screening|Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted.|||samples|||Number
2845738|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), Cycle 4, Day 28 (< median cutpoint, > = median cutpoint)and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.|||months||95% Confidence Interval|Median
2845739|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.|||months||95% Confidence Interval|Median
2845775|NCT00113490|Primary|Number of Subjects Exhibiting Anti-motavizumab Antibodies|Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.|Day 0 through 120 days post final dose|All subjects who received any study drug were included in all summaries of immunogenicity. Day 0 n=66 mota, n=70 pali; Day 25-30 n=65 mota, n=69 pali; Day 120 n=64 mota, n=67 pali; 30 days post final dose n=65 mota, n=67 pali; 90-120 days post final dose n=64 mota, n=67 pali; at any time n=66 mota, n=70 pali.|||participants|||Number
2845740|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), median and/or CI were not able to be estimated.|||months||95% Confidence Interval|Median
2845741|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
2845742|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint), and Cycle 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
2845743|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
2845744|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|[Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
2845745|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
2845746|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.|||weeks||95% Confidence Interval|Median
2845776|NCT00113425|Secondary|Change From Baseline in Acne Severity at Week 16|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 16||||units on a scale||95% Confidence Interval|Mean
2845747|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28.|||ratio|||Number
2845748|NCT00113516|Secondary|Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL|||Number
2845749|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.|||ratio|||Number
2845750|NCT00113516|Secondary|VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL|||Number
2845751|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.|||ratio|||Number
2845752|NCT00113516|Secondary|VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.|||pg/mL|||Number
2845753|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point|Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated.|||ratio||Standard Deviation|Mean
2845754|NCT00113516|Secondary|Soluble E-Selectin at Baseline|Concentration of soluble E-Selectin at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline.|||nanograms (ng)/mL||Standard Deviation|Mean
2845755|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
2845756|NCT00113516|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline.|||pg/mL||Standard Deviation|Mean
2845757|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point|VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.|||ratio||Standard Deviation|Mean
2845758|NCT00113516|Secondary|Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline|Concentration of VEGFR3 at baseline.|Baseline (Cycle 1, Day 1) of Part 2|Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib.|||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
2845759|NCT00113516|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
2845777|NCT00113425|Secondary|Change From Baseline in Erythematous Macules at Week 16||Baseline and Week 16||||erythematous macules||95% Confidence Interval|Mean
2845778|NCT00113425|Secondary|Change From Baseline in Open Comedones at Week 16||Baseline and Week 16||||open comedones||95% Confidence Interval|Mean
2845760|NCT00113516|Secondary|Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
2845761|NCT00113516|Secondary|Dose-Corrected Ctrough of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
2845762|NCT00113516|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
2845763|NCT00113516|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.|||ng/mL||Standard Deviation|Mean
2845764|NCT00113516|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2845765|NCT00113516|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death − date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.|From start of study treatment until death|ITT|||months||95% Confidence Interval|Median
2845766|NCT00113516|Secondary|Number of Subjects With Overall Confirmed Objective Disease Response|Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT|||participants|||Number
2845767|NCT00113516|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR.|||weeks||95% Confidence Interval|Median
2845768|NCT00113516|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT|||weeks||95% Confidence Interval|Median
2845769|NCT00113516|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT|||weeks||95% Confidence Interval|Median
2845770|NCT00113516|Primary|Proportion of Subjects Surviving at One Year|Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.|From start of treatment until 1 year or death|Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin.|||proportion|||Number
2845771|NCT00113490|Secondary|Motavizumab Serum Concentrations at Each Data Collection Visit|Mean serum concentration.|Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose|All subjects who received any study drug were included in all summaries. Day 0 n= 66; Day 25-30 n=65; Day 120 n=63; 30 days post final dose n=63; 90-120 days post final dose n=62|||ug/mL||Standard Deviation|Mean
2845793|NCT00113373|Secondary|Prognostic Variables: Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2845794|NCT00113373|Secondary|Prognostic Variable: Platinum Sensitivity|Patients who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Patients who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Patients who had disease progression beyond12 months of ending their last platinum regimen were also considered platinum sensitive.|Baseline|Eligible and evaluable patients|||Participants|||Count of Participants
2845795|NCT00113373|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2845796|NCT00113373|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months and then every 6 months for up to 5 years.|Eligible and evaluable patients|||months||95% Confidence Interval|Median
2845797|NCT00113373|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Baseline, every other cycle for 6 months and then every 6 months for up to 5 years|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2845798|NCT00113373|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and evaluable|||Participants|||Count of Participants
2845799|NCT00113373|Primary|Progression-free Survival (PFS) > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2845800|NCT00113360|Primary|Progression Free Survival (PFS)|PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.|PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated|Per protocol|||Weeks||95% Confidence Interval|Median
2845801|NCT00113334|Primary|Response Rate|Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon's optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.|Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.|Three (3) patients were inevaluable for response.|||participants|||Number
2845802|NCT00113321|Primary|Overall Response|Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.|Blood tests baseline and after completing 8-12 weeks of therapy|Treated population (16 patients); No further analysis done since study terminated early due to low accrual.|||Participants|||Number
2845803|NCT00113295|Secondary|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).|The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is used to assess quality of life changes with treatment. Total scores range from 14-70, with higher levels of satisfaction yielding higher scores.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)||||units on a scale||Standard Deviation|Mean
2845804|NCT00113295|Secondary|Depressive Symptoms, Montgomery-Asberg Depression Rating Scale (MADRS)|Depressive symptoms were measured at a secondary outcome using the Montgomery-Asberg Depression Rating Scale (MADRS). Each item is scored on a scale of 1-6; The total score range is 0-60, with higher scores indicated higher levels of depression severity.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)||||units on a scale||Standard Deviation|Mean
2848326|NCT00094900|Secondary|Mean Change in Serum Amyloid A||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
2845805|NCT00113295|Secondary|Response, Clinical Global Impression of Improvement (CGI-I)|"Response was measured as a secondary outcome using the Clinical Global Impression of Improvement (CGI-I). Response was defined as a score of 1 [very much improved] or 2 [much improved] at study endpoint."|Week 18 (Phase 2 Endpoint)||||participants|||Number
2845806|NCT00113295|Primary|Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.|"Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint.~The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD."|Baseline and Week 18|Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation, and all had at least one assessment postrandomization and were included in the phase 2 efficacy analyses; of this group, six randomized to quetiapine (54.5%) and ten to placebo (90.1%) completed the trial.|||units on a scale||Standard Deviation|Mean
2845807|NCT00113295|Secondary|Remission (HAM-A ≤ 7)|Remission was measured as a secondary outcome using a score of less than or equal to 7 on the Hamilton Anxiety Scale (HAM-A).|Week 18 (Study Endpoint)||||participants|||Number
2845808|NCT00113269|Secondary|Renal Function Abnormalities Based on Serum Creatinine|"Decrease in serum creatinine usually indicates an improvement.~Change in creatinine clearance from month 1 was calculated.~Change from 1 month is calculated by month 36 - month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.|||mcmol/L||Standard Deviation|Mean
2845809|NCT00113269|Secondary|Renal Function Abnormalities Based on Creatinine Clearance|"Increases in creatinine clearance usually indicates an improvement.~Change in creatinine clearance from month 1 was calculated.~Change from 1 month is calculated by month 36 - month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.|||mL/s||Standard Deviation|Mean
2845810|NCT00113269|Secondary|Overall Patient Survival|"Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2845811|NCT00113269|Secondary|Patient Survival at 12 Months|"Patient survival is defined as not dead within 12 months after skin closure.~Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2845812|NCT00113269|Secondary|Overall Graft Survival|"Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2845813|NCT00113269|Secondary|Graft Survival at 12 Months|"Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.~Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2845814|NCT00113269|Secondary|Time to First BCAR|"Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|"The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.~Only patients who experienced BCAR were included in the analysis."|||Days||Full Range|Median
2845815|NCT00113269|Secondary|Clinically Treated Acute Rejection|"Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2846486|NCT00108628|Secondary|Pittsburgh Sleep Quality Index - Addendum|The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2845816|NCT00113269|Secondary|Efficacy Failure|"Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2845817|NCT00113269|Secondary|Overall Patient Incidence of BCAR|"Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients|||Number
2845818|NCT00113269|Primary|Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months|"A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).~Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st."|6 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.|||Percentage of Patients||95% Confidence Interval|Number
2845819|NCT00113230|Primary|Pathologic Local Tumor Response|At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.|Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)|Intention to treat analysis method. Data examination conducted upon enrollment and evaluability of 25 patients.|||Participants|||Number
2845820|NCT00113217|Secondary|Safety of Treatment|Safety measured by participant toxicities in therapy with bevacizumab for Renal Cell Carcinoma (RCC).|Following 56 days treatment|||||||
2845821|NCT00113217|Primary|Progression Free Survival (PFS)|Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years (or until disease progression)||||months||95% Confidence Interval|Median
2845822|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with moderate to severe AV valve regurgitation.|at age 14 months|ITT, no imputation|||participants|||Number
2845823|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with Moderate to severe AV valve regurgitation.|just before the pre-Glenn surgery|ITT, no imputation|||participants|||Number
2845824|NCT00113087|Secondary|Ventricular Filling Pressure|Ventricular filling pressure measured by catherization|just before the Glenn surgery|ITT, no imputation|||mmHg||Standard Deviation|Mean
2845825|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)|||g/ml||Standard Deviation|Mean
2845826|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured just before the Glenn surgery|Intention-to-treat analysis of participants completing the pre-Glenn visit|||g/ml||Standard Deviation|Mean
2845827|NCT00113087|Secondary|End-diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845828|NCT00113087|Secondary|End Diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845829|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|at 14 months of age|ITT, no imputation|||ml||Standard Deviation|Mean
2845830|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||ml||Standard Deviation|Mean
2845831|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845832|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845833|NCT00113087|Secondary|Ventricular Mass|Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40|At 14 months of age|ITT, no imputation|||g||Standard Deviation|Mean
2845834|NCT00113087|Secondary|Ventricular Mass|Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation|||g||Standard Deviation|Mean
2848327|NCT00094900|Secondary|Mean Change in Serum Amyloid A||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/liter||Standard Error|Mean
2845835|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume.|at 14 months of age|ITT, no imputation|||percent (of end diastolic volume)||Standard Deviation|Mean
2845836|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume.|just before the Glenn surgery|ITT, no imputation|||percent (of end diastolic volume)||Standard Deviation|Mean
2845837|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Produced|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Inter-Quartile Range|Median
2845838|NCT00113087|Secondary|MacArthur-Bates Inventory -Total Gestures|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845839|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845840|NCT00113087|Secondary|MacArthur-Bates Inventory -Phrases Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845841|NCT00113087|Secondary|Neurodevelopmental Status (FSII)|Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders.|at 14 months of age|ITT, no imputation|||units on a scale||Inter-Quartile Range|Median
2845842|NCT00113087|Secondary|Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score|Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score .|at 14 months of age|ITT, not imputation|||standard deviation||Standard Deviation|Mean
2845843|NCT00113087|Secondary|Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score|"Neurodevelopmental status (PDI):~the Bayley Scales of Infant Development: Psychomotor Development index z-score ."|at 14 months of age|ITT, no imputation|||standard deviation||Standard Deviation|Mean
2845844|NCT00113087|Secondary|B-type Natriuretic Peptide Level|B-type natriuretic peptide (BNP) level.|at the time of the 14 month visit|ITT, no imputation|||pg/ml||Inter-Quartile Range|Median
2845845|NCT00113087|Secondary|B-Type Natriuretic Peptide|B-Type Natriuretic Peptide (BNP) level.|Measured just prior to the Glenn surgery|ITT analysis, no imputation|||pg/ml||Inter-Quartile Range|Median
2845846|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)|||participants|||Number
2845847|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Just prior to the pre-Glenn surgery|Intention-to-treat analysis of participants measured just prior to the Glenn surgery|||Participants|||Number
2845848|NCT00113087|Secondary|Head Circumference-for-age Z-score|Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation|||standard deviation||Standard Error|Least Squares Mean
2845849|NCT00113087|Secondary|Height-for-age Z-score|Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age||||standard deviation||Standard Error|Least Squares Mean
2845850|NCT00113087|Primary|Weight-for-age Z-score at 14 Months of Age|Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation|||standard deviation||Standard Error|Least Squares Mean
2845851|NCT00113022|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a measure of depression severity examined on a weekly basis. The minimum score on the 10 item scale is 0 indicating no depression. The maximum score is 60 indicating a very severe depression. Scores of 18 and above are generally considered to suggest significant levels of depression.|8 weeks||||Scores on a scale||Standard Error|Least Squares Mean
2845852|NCT00112957|Secondary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.|Continuously for up to 20 months|The Safety Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1.|||Participants|||Count of Participants
2845873|NCT00112866|Secondary|Plasma Concentration of EMD 121974|24 hour post dose concentration plasma, at time of resection|24 hour post concentration|6 of 8 and 7 of 11 plasma samples at the 500mg and 2000mg dose level respectively, were below the lower level of quantitation (LLOQ) Of the 15 samples in the low dose group only 8 were evaluable and 11 of the 15 for the high dose group. Samples were either damaged or too small for analysis.|||ng/ml||Standard Deviation|Mean
2845853|NCT00112957|Secondary|Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination|NY-ESO-1 antigen-specific delayed-type hypersensitivity (DTH) was measured by skin test at Screening and on Days 113 and 197. All patients were tested for the NY-ESO-1 protein, with additional DTH testing as follows: patients who were HLA-A2+ had NY-ESO-1b testing, patients who were HLA-DP4+ had NY-ESO-DP4 testing, and patients who were both HLA-A2+ and HLA-DP4+ had NY-ESO-1b and NY-ESO-DP4 testing.|Up to 6 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
2845854|NCT00112957|Secondary|Number of Patients With Detectable T-cell Responses Following Vaccination|NY-ESO-1-specific CD8+ T cells (human leukocyte antigen [HLA]-A2 patients only) and NY-ESO-1-specific CD4+ T cells (HLA-DP4 patients only) were measured by interferon-gamma enzyme-linked immunosorbent spot (ELISPOT) assay. The response to the ELISPOT assay was considered to be positive if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25,000 T-cells, or less if T-cell clones were used.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
2845855|NCT00112957|Secondary|Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens|Intracellular cytokine staining assays were performed at Screening, Days 85 and 197, Month 6, and Month 12 to evaluate the release of interferon-gamma by CD4 and CD8 T cells following study injections.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
2845856|NCT00112957|Secondary|Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity|Specific antibody response to the NY-ESO-1 and LAGE-1 antigen was measured by enzyme-linked immunosorbent assay (ELISA) at Screening, Days 29, 57, 85, 113, 141, 169, 197, Month 6, and Month 12.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
2845857|NCT00112957|Secondary|Mean Absolute Cancer Antigen-125 Values Over Time on Study|Blood samples were collected to measure serum levels of tumor marker cancer antigen (CA)-125 at Screening and on Days 1, 29, 57, 85, 113, 141, 169, and 197 and every 2 months for at least 12 months following Day 197.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||U/mL||Standard Deviation|Mean
2845858|NCT00112957|Secondary|Number of Patients With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and were categorized according to RECIST (version 1.0) at Screening, on Days 85 and 197 and every 2 months thereafter for at least 12 months. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions (no evaluable disease); Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||Participants|||Count of Participants
2845859|NCT00112957|Secondary|Mean Time to Failure Among Patients Who Progressed On Study|TTF was calculated as the number of days from the first dose until the patient discontinued due to progressive disease. Patients who completed the study or discontinued for other reasons were considered censored at the day of their last study visit, including the follow-up visits after Day 197. Progression was defined using the Response Evaluation Criteria In Solid Tumors (RECIST [version 1.0]) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 20 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. TTF was calculated for the subset of patients who had disease progression at any time.|||days||Standard Deviation|Mean
2845860|NCT00112957|Primary|Percentage of Patients in Remission at 1 Year|Time to failure (TTF) was evaluated as the crude proportion of patients in remission at 1 year, calculated as: 100 x (number of patients in remission at 1 year)/(number of patients with known status at 1 year). The Kaplan-Meier cumulative estimate of the proportion of patients in remission at 1 year was also calculated.|12 months|The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
2845861|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis|An overall survival event was death due to any cause.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.|||participants|||Number
2845950|NCT00112437|Secondary|Percentage Change From Baseline in Total Body BMD at 12 Months|Percentage change in total body BMD (relative to baseline) at 12 months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845862|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.|||months||95% Confidence Interval|Median
2845863|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events|An overall survival event was death due to any cause.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.|||participants|||Number
2845864|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Number of Events|A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.|||participants|||Number
2845865|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.|||months||95% Confidence Interval|Median
2845866|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Time to Event|Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.|||months||95% Confidence Interval|Median
2845867|NCT00112905|Secondary|Best Overall Response by RECIST|"This outcome measure reports the best response a patient has ever experienced.~<Target Lesions>~Complete Response (CR):~The disappearance of all target lesions, confirmed by assessments >=4 weeks (wks) later.~Partial Response:~>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments >=4 wks later.~Progressive Disease (PD):~>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions.~Stable Disease (SD):~Neither response criteria nor progressive disease criteria are met for >=8 wks.~<Nontarget Lesions>~CR:~The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments >=4 wks later.~SD:~Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for >=8 wks.~PD:~The appearance of new lesions or unequivocal progression of existing lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in the analysis.|||Participants|||Number
2845868|NCT00112905|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.|||Months||90% Confidence Interval|Median
2845869|NCT00112905|Secondary|Progression-free Survival|"Time from registration to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.|||Months||90% Confidence Interval|Median
2845870|NCT00112905|Primary|Kaplan-Meier Estimate of Progression-free Survival at 4 Months|"Survival estimate from the Kaplan-Meier curve of the proportion of patients alive and progression-free at 4 months.~Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Per protocol, the primary analysis included eligible patients who started protocol treatment.|||Percentage of Participants||90% Confidence Interval|Number
2845871|NCT00112866|Other Pre-specified|Overall Progression Free Survival|Kaplan-meier curve|1 year|Overall survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the this objective.|||weeks||95% Confidence Interval|Median
2845872|NCT00112866|Secondary|Tumor Tissue Concentrations|a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.|at time of surgery|8 500mg dose tissue samples and 10 2000mg dose tissue samples were either too small or had large areas of necrosis and gliosis to do analysis/evaluation|||ng/g||Standard Deviation|Mean
2845951|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter BMD at 12 Months|Percentage change in trochanter BMD (relative to baseline) at 12 months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845874|NCT00112866|Secondary|Changes in Endothelial Cell Apoptosis|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and up to 4 years|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
2845875|NCT00112866|Secondary|Changes in Tumor Cell Proliferation|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
2845876|NCT00112866|Secondary|Changes in Tumor Cell Apoptosis|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
2845877|NCT00112866|Secondary|Changes in Vitronectin Expression|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations planned, unfortunately, majority of tumor samples were too small to do both measures of drug and molecular analysis or sample was inadequate for both after removal of areas of necrosis and gliosis||||||
2845878|NCT00112866|Secondary|Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells|Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.|Baseline and time of surgery|Molecular analyses evaluating alterations after cilengitide treatments were planned as a component of this clinical trial, unfortunately, the majority of tumor samples were too small to do both measures of drug and molecular analysis or the sample was inadequate for both after removal of areas of necrosis and gliosis||||||
2845879|NCT00112866|Primary|6m-Progression-free Survival|progression within 6 months (26 weeks) of treatment|6 months|6months progression free survival based on the post surgical treatment. All patients received 2000mg post surgery. The pre-surgery dose was used for correlative purposes only. All patients received surgery and the doses pre-surgery have no relation to the primary objective.|||percent|||Number
2845880|NCT00112840|Secondary|Overall Survival (Phase I and II)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants were used for this endpoint.|||months||95% Confidence Interval|Median
2845881|NCT00112840|Secondary|Time to Progression (Phase II)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants in Phase II were used for this endpoint.|||months||95% Confidence Interval|Median
2845882|NCT00112840|Secondary|Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)|"The number of participants with clinical tumor response to treatment will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 3 years from study registration|All eligible Phase II patients were used to assess this endpoint.|||percentage of participants|||Number
2845883|NCT00112840|Primary|Proportion of Progression-free Patients at 6 Months (Phase II)|Determination of progression will be made according to Response Evaluation Criteria in Solid Tumors (RECIST). A progression (PD) is defined as having at least a 20% increase in the sum of the longest dimension of target lesions taking as reference the smallest sum of the largest dimension recorded at baseline.The proportion of progression-free patients will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the success proportion will be calculated. All patients meeting the eligibility criteria who have signed a consent form and begun treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|6 months after study entry|Only Phase II participants were analyzed for this endpoint. Forty participants from Phase II were evaluable for this endpoint.|||percentage of participants||95% Confidence Interval|Number
2845884|NCT00112840|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria:~Grade 4 Absolute neutrophil count (ANC) for 5+ days.~Grade 4 anemia or thrombocytopenia of any duration.~Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal.~Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication.~Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.~The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose."|Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.||||participants|||Number
2846487|NCT00108628|Primary|Pittsburgh Sleep Quality Index|Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2845885|NCT00112736|Primary|Progression-free Survival at 6 Months (Phase II)|"Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).~Responses had to be present on 2 consecutive scans and were centrally reviewed."|Evaluated at baseline and every other cycle, till Month 6|Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% & 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%.|||participants|||Number
2845886|NCT00112736|Primary|Pharmacokinetics (Phase I)|"Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels~blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1~Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration"|Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration|per protocol|||ng/mL||Standard Deviation|Mean
2845887|NCT00112736|Primary|Efficacy - Response Phase 1|"pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan.~Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): >= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer)."|at least 8 weeks of treatment|Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)|||participants|||Number
2845888|NCT00112736|Primary|Safety/Dose Limiting Toxities Phase I|"Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade >/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy.~MTD defined as dose at which fewer than one-third of patients experienced a DLT~Outcome measure defines number of participants who had a defined dose limiting toxicity."|first 4 weeks of treatment||||participants|||Number
2845889|NCT00112736|Primary|Maximum Tolerated Dose (Phase I)|"Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed.~3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg"|based on first 4 weeks of treatment - cycle 1|Per protocol -|||mg|||Number
2845890|NCT00112723|Secondary|Pharmacokinetics (Cmax) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1||||μM||Standard Deviation|Mean
2845891|NCT00112723|Secondary|Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).|The correlation of the pharmacodynamic effects of flavopiridol on normal peripheral blood mononuclear cells (PBMCs)|Day 1|Data not available due to studies were not conducted by collaborating laboratory Investigator||||||
2845892|NCT00112723|Secondary|Induced Response in Patients Independent of p53 Mutational Status|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years|Data not available due to studies were not conducted by collaborating laboratory Investigator||||||
2845893|NCT00112723|Secondary|Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)||Up to 30 days after completion of study treatment||||patients|||Number
2845894|NCT00112723|Secondary|Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1|total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment|||hr×μM||Standard Deviation|Mean
2845895|NCT00112723|Primary|Lymphoid/Plasma Cell Malignancies|Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.|Up to 2 years|Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL|||patients|||Number
2845896|NCT00112723|Primary|Qualitative and Quantitative Toxicities in Regard to Organ Specificity|The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.|Up to 30 days after completion of study treatment|Grade 3 and 4 toxicities.|||percentage of patients|||Number
2845897|NCT00112723|Primary|Complete and Partial Response Rate (Phase II)|Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.|Up to 2 years|Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL|||patients|||Number
2845898|NCT00112723|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.|28 days||||mg/m2|||Number
2845952|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck BMD at 12 Months|Percentage change in femoral neck BMD (relative to baseline) at 12 months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845899|NCT00112723|Primary|Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)|Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.|28 days||||patients|||Number
2845900|NCT00112671|Secondary|Frequency of Common Grade 3 Adverse Events|Will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 5 years||||common grade 3 events|||Number
2845901|NCT00112671|Secondary|Progression-free Survival|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Survival estimates will be computed using the Kaplan-Meier method. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated.|From start of treatment to progression or death, assessed up to 1 year|3 months progression free survival|||percentage of participants||95% Confidence Interval|Median
2845902|NCT00112671|Secondary|Time to Progression|Progression is defined using the Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.|Up to 5 years||||months||95% Confidence Interval|Median
2845903|NCT00112671|Secondary|Number of Participants With Stable Disease for More Than 3 Months|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From the start of the treatment until the criteria for progression are met, up to 5 years|Stable disease for more than 3 months|||participants|||Number
2845904|NCT00112671|Primary|Number of Paricipants With Tumour Response Defined as Partial or Complete Response Per the RECIST 1.0 Criteria|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 5 years||||participants|||Number
2845905|NCT00112593|Secondary|Reconstitution of HIV-specific Immunity||Up to 1 year||||Participants|||Count of Participants
2845906|NCT00112593|Secondary|Progression of HIV|Count of participants with HIV progression.|Within 1 year||||Participants|||Count of Participants
2845907|NCT00112593|Secondary|Overall Survival|Kaplan-Meier estimate assessed at 1 year.|Up to 1 year||||survival probability||95% Confidence Interval|Number
2845908|NCT00112593|Primary|Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin|Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor.|Up to day 80||||Participants|||Count of Participants
2845909|NCT00112593|Primary|Death From GVHD||Within the first 360 days||||Participants|||Count of Participants
2845910|NCT00112593|Primary|Death From Regimen Toxicity or Opportunistic Infection||Within the first 100 days||||Participants|||Count of Participants
2845911|NCT00112489|Primary|Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response|"Primary outcome measured according to RECIST v1.0 Best Response:~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (q 6 weeks) until disease progression is documented.|Total eligible and treated participants|||participants|||Number
2845912|NCT00112489|Primary|Nature and Degree of Toxicity|Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0|During study treatment and up to 30 days after stopping study treatment|Eligible and Evaluable patients|||Participants|||Count of Participants
2845913|NCT00112463|Secondary|Survival|Months from first treatment until death or the last date of contact|Max of 98 months|All treated participants|||months||95% Confidence Interval|Median
2845914|NCT00112463|Primary|Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3|"The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study.~A summary of the individual toxicities can be found in the AE/SAE results."|During treatment (max of 16 months) and for 1 month following treatment|All treated participants|||Participants|||Count of Participants
2845915|NCT00112463|Primary|Time to Progression|Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.|Until disease progression - max of 48 months|All treated participants|||months||95% Confidence Interval|Median
2845953|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip BMD at 12 Months|Percentage change in total hip BMD (relative to baseline) at 12 months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2845916|NCT00112463|Primary|Objective Tumor Response (Complete and Partial)|Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR|While on treatment - max of 16 months|Participants who were evaluable for response|||Participants|||Count of Participants
2845917|NCT00112437|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Years 6-10 (up to 60 months)|All participants who received at least 1 administration of the trial drug during treatment years 6-10.|||Participants|||Number
2845918|NCT00112437|Primary|Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)|All participants who received at least 1 administration of the trial drug during treatment years 6-10|||Participants|||Number
2845919|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 120 Months|Percentage change from baseline in lumbar spine BMD at 120 Months.|Baseline and Month 120|This analysis was based on the FAS population, which included all randomized participants who took at least 1 dose of extension study drug and had the necessary extension data available for this endpoint. Missing data were not imputed.|||Percentage Change||95% Confidence Interval|Mean
2845920|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 60 Months|Percentage change from baseline in lumbar spine BMD at 60 months.|Baseline and Month 60|All participants who took at least one dose of base study medication and at least one dose of extension medication. Missing values were imputed using last observation-carried-forward principle.|||Percentage change||95% Confidence Interval|Mean
2845921|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845922|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845923|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845924|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
2845925|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845926|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2846488|NCT00108628|Primary|Weekly Nights With a Nightmare||Baseline and 1, 3, and 6 months post-treatment||||nights/week||Standard Deviation|Mean
2845927|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months|Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845928|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm BMD at 36 Months|Percentage change in distal forearm BMD (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2845929|NCT00112437|Secondary|Percentage Change From Baseline in Total Body BMD at 36 Months|Percentage change from baseline in total body BMD (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845930|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter BMD at 36 Months|Percentage change in trochanter BMD (relative to baseline) at 36 months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2845931|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck BMD at 36 Months|Percentage change in femoral neck BMD (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845932|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip BMD at 36 Months|Percentage change in total hip BMD (relative to baseline) at 36 months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845933|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 36 Months|Percentage change in lumbar spine BMD (relative to baseline) at 36 months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.|||Percent Change||95% Confidence Interval|Least Squares Mean
2845934|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months|Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
2845935|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
2845936|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
2845937|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2846258|NCT00110812|Post-Hoc|CD4+ Cell Count 2 Years Post-study||two years following close of main study|All patients for whom a CD4 count measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||cell/mm^3||Standard Deviation|Mean
2845938|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845939|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm BMD at 24 Months|Percentage change in distal forearm BMD (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845940|NCT00112437|Secondary|Percentage Change From Baseline in Total Body BMD at 24 Months|Percentage change in total body BMD (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward. No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845941|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter BMD at 24 Months|Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2845942|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck BMD at 24 Months|Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845943|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months|Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845944|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845945|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845946|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845947|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.|Baseline and 12 Months|This analysis was a geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845948|NCT00112437|Secondary|Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months|Baseline and 12 Months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845949|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm BMD at 12 Months|Percentage change in distal forearm BMD (relative to baseline) at 12 months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward|||Percentage change||95% Confidence Interval|Least Squares Mean
2845954|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine BMD at 24 Months|Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.|Baseline and 24 months|Analysis on lumbar spine BMD (g/cm2) at Month 24 used the Full-Analysis-Set Population with Last Observation Carried Forward from Month 18 to 24. No data were carried forward from the core to the extension period. Only patients who took at least one dose of extension medication were included. 17 patients were excluded from FAS.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2845955|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.|Baseline and 12 months|Analysis at Month 12 used Full-Analysis-Set Population of participants who took at least one dose of study medication and had necessary follow-up information, in their randomization treatment group, with last observation data carried forward. Seven patients had a baseline value, but no value at Month 12 for lumbar spine Bone Mineral Density.|||Percentage change||95% Confidence Interval|Least Squares Mean
2845956|NCT00112385|Secondary|Average Daily Dose of Prednisone From Baseline to Week 52|The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.|Baseline through Week 52||||mg||Standard Deviation|Mean
2845957|NCT00112385|Primary|Average Cumulative Dosage of Prednisone Over the One Year Study Period|The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.|Baseline until week 52||||mg||Standard Deviation|Mean
2845958|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52."|Screening visit, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845959|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52."|At Screening, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845960|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit."|Screening visit and Week 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845961|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845962|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845963|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845964|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845965|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845966|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845967|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845968|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2846034|NCT00112112|Secondary|Influenza A/H3N2 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846489|NCT00108628|Primary|Weekly Number of Nightmares||Baseline and 1, 3, and 6 months post-treatment||||weekly nightmares||Standard Deviation|Mean
2845969|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845970|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845971|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845972|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845973|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline.~Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2845974|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."|||participants|||Number
2846035|NCT00112112|Secondary|Influenza A/H1N1 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846537|NCT00107900|Secondary|Change From Baseline for Prothrombin Time (PT) Results|Intent to Treat (ITT) population|end of treatment|ITT population|||seconds||Standard Deviation|Mean
2845975|NCT00112385|Primary|Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.|"The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Kilograms||Standard Deviation|Mean
2845976|NCT00112385|Primary|Average Change in Pulse Comparing Baseline to Week 52|"The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||beats per minute||Standard Deviation|Mean
2845977|NCT00112385|Primary|Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.|"The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||mmHg||Standard Deviation|Mean
2845978|NCT00112385|Primary|Average Change in Systolic Blood Pressure From Baseline to Week 52|"The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||mmHg||Standard Deviation|Mean
2845979|NCT00112385|Primary|Average Change in Respiration Rate From Baseline to Week 52|"The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||breaths per minute||Standard Deviation|Mean
2845980|NCT00112385|Primary|Average Change in Oral Temperature From Baseline to Week 52|"The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week 0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||degrees Celsius||Standard Deviation|Mean
2845981|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52|"Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed during the Week 24 visit."|Screening visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Percent predicted||Standard Deviation|Mean
2845982|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52|"The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed during the Week 24 visit."|Screening Visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Percent predicted||Standard Deviation|Mean
2846036|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin M (IgM)|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846571|NCT00107575|Primary|Smoking Abstinence at 16 Weeks|7 days of smoking abstinence confirmed biochemically at 16 weeks|16 weeks||||Participants|||Number
2845983|NCT00112385|Other Pre-specified|Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.|"The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed at the Week 24 visit."|Screening Visit and Week 52.|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Percent predicted||Standard Deviation|Mean
2845984|NCT00112385|Other Pre-specified|Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52|"The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment.~The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Units on a scale||Standard Deviation|Mean
2845985|NCT00112385|Other Pre-specified|Change in Pruritis Rating From Baseline to Week 52|"This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated Not itchy at all. A score of 10.0 cm indicated Extremely itchy.~This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0), and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||cm||Standard Deviation|Mean
2845986|NCT00112385|Other Pre-specified|Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline|"Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Units on a scale||Standard Deviation|Mean
2845987|NCT00112385|Other Pre-specified|Average Change in Patient Global Activity Assessment Score From Baseline to Week 52|"Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease.~This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||cm||Standard Deviation|Mean
2845988|NCT00112385|Other Pre-specified|Average Change in Physician Global Activity Assessment From Baseline to Week 52|"Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||cm||Standard Deviation|Mean
2845989|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52|The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit.|Screening visit and Week 52.|Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.|||Z-Score||Standard Deviation|Mean
2845990|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52|"The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit).~The Screening visit was conducted within 8 weeks of the Baseline visit."|Screening and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."|||Z-score||Standard Deviation|Mean
2846037|NCT00112112|Secondary|Influenza B IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2845991|NCT00112385|Other Pre-specified|Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52|"Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Seconds||Standard Deviation|Mean
2845992|NCT00112385|Other Pre-specified|Average Change in Time to Rise From a Chair From Baseline to Week 52|"The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Seconds||Standard Deviation|Mean
2845993|NCT00112385|Primary|Tolerability|The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.|At any point between Baseline (week 0) and the end of the study (Week 52)||||Participants|||Number
2845994|NCT00112385|Other Pre-specified|Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52|"The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130.~The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline)."|At Baseline (Week 0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.|||Units on a scale||Standard Deviation|Mean
2845995|NCT00112385|Secondary|Average Prednisone Dosage After Week 24|We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).|from week 24 to 52||||mg||Inter-Quartile Range|Median
2845996|NCT00112385|Other Pre-specified|The Number of Participants Who Were Classified as Treatment Failures|Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure.|At any point during the 52 week study||||participants|||Number
2845997|NCT00112385|Primary|Occurrence of at Least One Adverse Event|"Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of mild, moderate or severe matches with the descriptions from the CTCAE dictionary.~In general, a Mild AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated.~A Moderate AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living.~A Severe AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;"|at each visit during the 12 month study|Intention- to -Treat (ITT)|||participants|||Number
2845998|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||μg/mL|Participants||Number
2845999|NCT00112359|Secondary|Number of Participants Hospitalized at Least Once Between Day 0 and Day 42|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||participants|||Number
2846000|NCT00112359|Primary|Change in CFQ-R Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||units on a scale||Standard Error|Least Squares Mean
2846001|NCT00112359|Secondary|Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug|Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received.|||participants|||Number
2846038|NCT00112112|Secondary|Influenza B IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2848328|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
2846002|NCT00112359|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
2846003|NCT00112359|Secondary|Percent Change in FEV1 (L)|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28.|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
2846004|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||μg/mL|Participants||Number
2846005|NCT00112359|Other Pre-specified|Number of Participants With Other Pathogens Present|Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.|||participants|||Number
2846006|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 42|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||units on a scale||Standard Error|Least Squares Mean
2846007|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 14|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.|||units on a scale||Standard Error|Least Squares Mean
2846008|NCT00112294|Secondary|Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures|Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals & other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study & therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.|Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).|This analysis was not performed.||||||
2846009|NCT00112294|Secondary|Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose >13.9 - 27.8 mmol/L; Grade 4 >27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium >1.23 - 3.30 mmol/L; Grade 4 >3.30 mmol/L. Hyponatremia: Grade 3, serum sodium <130 - 120 mmol/L; Grade 4 <120 mmol/L. Low albumin: Grade 3, serum albumin <20 g/L; Grade 4 not applicable.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
2846010|NCT00112294|Other Pre-specified|Median Change From Baseline in Symptoms, by Time Point|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization). n = number of participants with a score at both the baseline and at the specified time point (each arm respectively).|||Units on a scale||Inter-Quartile Range|Median
2846039|NCT00112112|Secondary|Influenza A/H3N2 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846011|NCT00112294|Secondary|Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Leukopenia: Grade 3, leukocytes <2.0 - 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L. Thrombocytopenia: Grade 3, platelets <50.0 - 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Anemia: Grade 3, hemoglobin <4.9 - 4.0 millimoles (mmol)/L, Grade 4, <4.0 mmol/L.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
2846012|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Cardiac AEs|"An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term cardiac AE were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities [MedDRA] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death."|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
2846013|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Infusion Reaction|"AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term infusion reaction were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment."|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
2846014|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Acneform Rash|"An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term acneform rash were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin."|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||Participants|||Number
2846015|NCT00112294|Secondary|Number of Participants Experiencing AEs Leading to Study Drug Discontinuation|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.|||participants|||Number
2846016|NCT00112294|Secondary|Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants. The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|||Participants|||Number
2846017|NCT00112294|Secondary|Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as >= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score greater than or equal to 2. As the median was not reached, no data are presented here (see Outcome Measure 15).||||||
2846018|NCT00112294|Secondary|Number of Participants With Improvement of Symptoms|Symptoms were assessed using the Functional Assessment of Cancer Therapy - Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as >= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of >= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, who completed a questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score of 26 or less.|||Participants|||Number
2846019|NCT00112294|Secondary|Median Number of Months of Survival|The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.|From randomization to death or date of last contact (up to 41 months).|All randomized participants (intention to treat population).|||Months||95% Confidence Interval|Median
2846040|NCT00112112|Secondary|Influenza A/H3N2 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2848329|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
2846020|NCT00112294|Secondary|Median Number of Months to Response|The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).|All randomized participants with a best response of CR or PR.|||Months||Full Range|Median
2846021|NCT00112294|Secondary|Median Number of Months of Response|Median number of months of response (time from first occurrence of CR/PR to date of PD/death, [per IRRC assessment,using modified WHO criteria]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.|Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).|All randomized participants with a best response of CR or PR.|||Months||95% Confidence Interval|Median
2846022|NCT00112294|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).|||Participants|||Number
2846023|NCT00112294|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).|||Participants|||Number
2846024|NCT00112294|Primary|Median Number of Months of Progression-free Survival (PFS)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).|All randomized participants (intention to treat population).|||Months||95% Confidence Interval|Median
2846025|NCT00112151|Secondary|Fat Free Mass (kg)|Total change in Fat free mass (kg) as evaluated by DXA|Baseline and 12 months||||kg||Standard Deviation|Mean
2846026|NCT00112151|Secondary|Fat Mass (kg)|Total change in Fat mass (kg) as evaluated by DXA|Baseline and 12 months||||kg||Standard Deviation|Mean
2846027|NCT00112151|Secondary|Power (Power Rig, Watts)|Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).|Baseline and 12 months||||Watts||Standard Deviation|Mean
2846028|NCT00112151|Secondary|Lower Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.|Baseline and 12 months||||kg||Standard Deviation|Mean
2846029|NCT00112151|Secondary|Upper Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.|Baseline and 12 months||||kg||Standard Deviation|Mean
2846030|NCT00112151|Primary|Physical Function (CS-PFP Total Score)|Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2846031|NCT00112112|Secondary|Influenza B IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846032|NCT00112112|Secondary|Influenza B IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846033|NCT00112112|Secondary|Influenza A/H3N2 IgM|Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2848005|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2846041|NCT00112112|Secondary|Influenza A/H1N1 IgG|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846042|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin G (IgG)|Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846043|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils|Mean and standard deviation results of absolute neutrophils subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Cells per 10^3/UL||Standard Deviation|Mean
2846044|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes|Mean and standard deviation results of absolute lymphocytes subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Cells per 10^3/UL||Standard Deviation|Mean
2846045|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes|Mean and standard deviation results of absolute lymphocytes subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Cells per 10^3/UL||Standard Deviation|Mean
2846046|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes|Mean and standard deviation results of lymphocytes subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
2846047|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes|Mean and standard deviation results of lymphocytes subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
2846048|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells|Mean and standard deviation results of white blood cells subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^3/UL||Standard Deviation|Mean
2846049|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells|Mean and standard deviation results of white blood cells subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^3/UL||Standard Deviation|Mean
2846050|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD56|Mean and standard deviation results of CD56 lymphocyte subsets is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percent of lymphocytes||Standard Deviation|Mean
2846051|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD56|Mean and standard deviation results of CD56 lymphocyte subsets is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percent of lymphocytes||Standard Deviation|Mean
2846052|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846053|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846054|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846055|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846056|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846057|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846058|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846059|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846060|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846061|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846062|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846063|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|14-28 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846064|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846065|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|3-5 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846066|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin A (IgA)|Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||titer||Standard Deviation|Mean
2846067|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza B Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
2846068|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
2846069|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
2846070|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
2846071|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
2846072|NCT00112112|Secondary|Number of Participants Who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported.|Baseline (pre-dosing on Day 0) and 35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the samples available for the specified days were analysed.|||participants|||Number
2846073|NCT00112112|Secondary|HLA Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
2846074|NCT00112112|Secondary|HLA Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
2846075|NCT00112112|Secondary|Human Leukocyte Antigen (HLA) Matched Tetramers CD8+|The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||Percentage of lymphocytes||Standard Deviation|Mean
2846076|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
2846077|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
2846078|NCT00112112|Secondary|Interleukin (IL)-4|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
2846079|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|35-42 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
2846080|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
2846081|NCT00112112|Secondary|Interferon (INF)-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells is reported.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||cells per 10^5 T cells||Standard Deviation|Mean
2846082|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846083|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846084|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846085|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|7-10 days after study vaccination|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846086|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846215|NCT00111475|Secondary|Change From Baseline in Peak Platelet Count in Part B|Platelet count data after administration of rescue medication were not included in the analysis.|Baseline and day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||1 × 10⁹ cells/L||Standard Deviation|Mean
2846087|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846088|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846089|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had the sample available for the specified day were analysed.|||percentage of lymphocytes||Standard Deviation|Mean
2846090|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|Unscheduled visits occurring during 0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|participants w/unsched. illness visits||Number
2846091|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.|35-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
2846092|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|14-28 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
2846093|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|7-10 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
2846094|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus are reported.|3-5 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
2846095|NCT00112112|Primary|Number of Significant New Medical Conditions (SNMCs)|A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.|43-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||events|||Number
2846096|NCT00112112|Primary|Number of Participants Who Had Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||participants|||Number
2846097|NCT00112112|Primary|Number of Participants Who Had Serious Adverse Events (SAEs)|An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.|0-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.|||Participants|||Number
2846098|NCT00112112|Primary|Number of Participants Who Had Reactogenicity Events (REs)|Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.|||participants|||Number
2846099|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Composite Score||Standard Deviation|Mean
2846100|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Composite Score||Standard Deviation|Mean
2846101|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
2846102|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
2846103|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
2846104|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
2846105|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set|||Participants|||Number
2846106|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||total body fat (kg)||Standard Deviation|Mean
2846107|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||trunk fat (kg)||Standard Deviation|Mean
2846108|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||limb fat (kg)||Standard Deviation|Mean
2846109|NCT00112047|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)|Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value|Study/Atripla baseline to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||CD4 Cell count (Cells/mm^3)||Standard Deviation|Mean
2846110|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"|||Percentage of Participants|||Number
2846111|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"|||Percentage of Participants|||Number
2846216|NCT00111475|Secondary|Peak Platelet Count in Part B|Platelet count data after administration of rescue medication were not included in the analysis.|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||1 × 10⁹ cells/L||Standard Deviation|Mean
2846112|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
2846113|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
2846114|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
2846115|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
2846116|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set|||Percentage of Participants|||Number
2846117|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.|||Percentage of Participants|||Number
2846118|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)|||total body fat (kg)||Standard Deviation|Mean
2846119|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)|||trunk fat (kg)||Standard Deviation|Mean
2846120|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)|||limb fat (kg)||Standard Deviation|Mean
2846121|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144|Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 144|AT analysis set|||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
2846122|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144|Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 144|AT analysis set|||Log10 c/mL||Standard Deviation|Mean
2846123|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT|||Percentage of Participants|||Number
2846124|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT|||Percentage of participants|||Number
2846217|NCT00111475|Secondary|Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B|Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||percentage of participants|||Number
2846125|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Week 144|MITT|||Percentage of Participants|||Number
2846126|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Week 144|MITT|||Percentage of Participants|||Number
2846127|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set (Missing Observation or Switch in ART=Failure)|||Percentage of Participants|||Number
2846128|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set|||Percentage of Participants|||Number
2846129|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit.|Week 144|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 458).|||Percentage of participants|||Number
2846130|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit.|144 weeks|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 456).|||Percentage of Participants|||Number
2846131|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value|48 weeks to 96 weeks|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)|||total body fat (kg)||Standard Deviation|Mean
2846132|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 96|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)|||trunk fat (kg)||Standard Deviation|Mean
2846133|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.|Week 48 to Week 96|ITT (whole body dual-energy X-ray absorptiometry [DEXA] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)|||limb fat (kg)||Standard Deviation|Mean
2846134|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96|Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
2846135|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96|Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||Log10 c/mL||Standard Deviation|Mean
2846136|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT|||Percentage of Participants|||Number
2846137|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT|||Percentage of Participants|||Number
2846218|NCT00111475|Secondary|Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B|Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||percentage of participants|||Number
2846138|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Week 96|MITT|||Percentage of Participants|||Number
2846139|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96|TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.|Week 96|MITT|||Percentage of Participants|||Number
2846140|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit.|Week 96|Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [465])|||Percentage of Participants|||Number
2846141|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit.|96 Weeks|Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [463])|||Percentage of Participants|||Number
2846142|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value|Study baseline to Week 48|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
2846143|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48|Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 48|As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.|||Log10 c/mL||Standard Deviation|Mean
2846144|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set|||Percentage of participants|||Number
2846145|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set|||Percentage of Participants|||Number
2846146|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Baseline to 48 Weeks|ITT analysis set|||Percentage of Participants|||Number
2846147|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48|"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1."|Baseline to 48 weeks|ITT analysis set|||Percentage of Participants|||Number
2846148|NCT00112047|Secondary|Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|48 Weeks|ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).|||Percentage of Participants|||Number
2846219|NCT00111475|Secondary|Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B|Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||percentage of participants|||Number
2846149|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|48 weeks|Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).|||Percentage of Participants|||Number
2846150|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit.|Week 48|MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])|||Percentage of Participants|||Number
2846151|NCT00112047|Primary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit.|48 weeks|Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])|||Percentage of participants|||Number
2846152|NCT00111917|Post-Hoc|BAL % Lymphocytes|% of WBCs that are lymphocytes in bronchoalveolar lavage|after 28 week infusion||||percentage of lymphocytes in BAL||Standard Deviation|Median
2846153|NCT00111917|Post-Hoc|BAL WBC/cc|WBC * 10^6/cc in bronchalveolar lavage|after 28 weeks||||absolute WBC*10^6/cc||Standard Deviation|Median
2846154|NCT00111917|Primary|A-a Gradient at End Exercise|change in end-exercise A-a gradient|after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen|Accurate measures were not obtained on all patients at both timepoints.|||mmHg||Standard Error|Median
2846155|NCT00111917|Post-Hoc|Absolute Numbers of Lymphocytes|Absolute number of lymphocytes*10^6/cc in blood|after 28 week follow-up||||absolute number*10^6/cc||Standard Error|Median
2846156|NCT00111839|Secondary|Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain] and 3 items were global items (symptom distress, interference with activity level, and global QoL). The global QoL item scores are reported here. The total global QoL item score ranged from 0 (worse QoL) to 100 (best QoL).|Baseline, Cycle 2 (Cycle length = 3 weeks)|ITT population. Here, overall number of participants analyzed = participants with available data for this outcome; number analyzed = participants with available data at specified timepoint.|||units on a scale||Standard Deviation|Mean
2846157|NCT00111839|Secondary|Duration of Objective Response Assessed by Independent Review Committee|Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (>25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.|From first documented objective response to PD or death due to any cause (up to approximately 3.5 years)|ITT population.|||months||95% Confidence Interval|Median
2846158|NCT00111839|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.|Baseline up to PD or death due to any cause (up to approximately 3.5 years)|ITT population.|||months||95% Confidence Interval|Median
2846159|NCT00111839|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.|Baseline up to PD or death due to any cause (up to approximately 3.5 years)|ITT population.|||months||95% Confidence Interval|Median
2846160|NCT00111839|Primary|Number of Participants With Objective Response Assessed by Independent Review Committee|Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. Complete response: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.|Baseline up to PD or death due to any cause (up to approximately 2 years)|ITT population.|||participants||95% Confidence Interval|Number
2846220|NCT00111475|Secondary|Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B|Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders.|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||percentage of participants|||Number
2846161|NCT00111813|Secondary|Laboratory AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.~A lab (S)AE was any lab value considered clinically significant in the investigator's judgment."|Day 1 up to disease progression, toxicity, or death, assessed up to 29 months||||Participants|||Number
2846162|NCT00111813|Secondary|Clinical AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.~A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose."|Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)||||Participants|||Number
2846163|NCT00111813|Secondary|Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months||||Days||Standard Deviation|Mean
2846164|NCT00111813|Secondary|Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug|An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months||||Participants|||Number
2846165|NCT00111813|Primary|Mean Duration of Treatment With Vorinostat|"Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.~Progressive disease was defined as:~>25% increase in the level of serum monoclonal paraprotein.~25% increase in 24-hour urinary light chain excretion.~>25% increase in plasma cells in a bone marrow aspirate or on trephine~biopsy.~Development of new bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia.~Intolerable toxicity was based on the clinical judgment of the investigator."|Day 1 to an event causing discontinuation from the study, assessed up to 29 months||||Days||Full Range|Mean
2846166|NCT00111800|Secondary|Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK|A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.|Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20|PPK Population. The data for this outcome measure was not collected.||||||
2846167|NCT00111800|Secondary|Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN|A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.|Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20|Sparse PK (PPK) Population comprised of all those participants who were assigned to the sparse (population PK) group. All consenting participants were eligible for inclusion in the sparse PK population except for those participants participating in the serial PK assessment. The data for this outcome measure was not collected.||||||
2846168|NCT00111800|Secondary|Number of Participants With Urinalysis Microscopic Result|The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).|Up to Follow-up (Week 25)|Safety Population.|||Participants|||Count of Participants
2846169|NCT00111800|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Result|The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).|Up to Follow-up (Week 25)|Safety Population.|||Participants|||Count of Participants
2846170|NCT00111800|Secondary|Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy|The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.|Up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2848330|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
2846171|NCT00111800|Secondary|Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy|The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase ([LDH] if >2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.|Up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2846172|NCT00111800|Secondary|Change From Baseline in 12-lead ECG Over Time|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
2846173|NCT00111800|Secondary|Mean Change From Baseline in Waist to Hip Ratio Over Time|Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2846174|NCT00111800|Secondary|Change From Baseline in Waist Circumference and Hip Circumference Over Time|Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Centimeter (cm)||Standard Deviation|Mean
2846175|NCT00111800|Secondary|Change From Baseline in Body Mass Index (BMI) Over Time|BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) and Week -5 to 25 (Follow-up)|Safety Population. Only those participants available at the specified time points were analyzed.|||kg/meter square (m^2)||Standard Deviation|Mean
2846176|NCT00111800|Secondary|Change From Baseline in Body Weight Over Time|The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.|Baseline (Week 0) and Week -5 to 25 (Follow-up)|Safety Population. Only those participants available at the specified time points were analyzed.|||Kilogram (kg)||Standard Deviation|Mean
2846177|NCT00111800|Secondary|Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy|The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline >30 beats per minute (bpm) and <50 or >120 bpm; SBP increase or decrease from Baseline >30 millimeter of mercury (mmHg) in the same posture and >170 or <100 mmHg; increase or decrease from Baseline >20 mmHg in same posture and >110 or <50 mmHg.|Baseline (Week 0) up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2846178|NCT00111800|Secondary|Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities.|Up to Week 25|Safety Population.|||Participants|||Count of Participants
2846179|NCT00111800|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia.|Up to Week 25|Safety population was defined as all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2846180|NCT00111800|Secondary|Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8|The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 4 and 8|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2846181|NCT00111800|Secondary|Change From Baseline in Pro-insulin to Insulin Ratio at Week 12|The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
2846182|NCT00111800|Secondary|Change From Baseline in Pro-insulin at Week 16, 20 and 24.|The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population without LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
2846183|NCT00111800|Secondary|Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8|The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
2846184|NCT00111800|Secondary|Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12|The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Picomole (pmol)/L||Standard Error|Least Squares Mean
2846185|NCT00111800|Secondary|Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24|The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||µmol/L||Standard Deviation|Mean
2846186|NCT00111800|Secondary|Change From Baseline in Fructosamine at Week 12|The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Micromole (µmol/L)||Standard Error|Least Squares Mean
2846187|NCT00111800|Secondary|Number of Participants of FPG Responders at Week 12|The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of <7 mmol/L and FPG reduction value of >=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.|Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2846255|NCT00110890|Primary|Number of Participants With Mean PTH ≤ 300 pg/mL|Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
2846188|NCT00111800|Secondary|Number of Participants Who Were HbA1c Responders at Week 12|HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of <=6.5%, <7% and HbA1c reduction of >=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.|Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2846189|NCT00111800|Secondary|Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24|The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
2846190|NCT00111800|Secondary|Change From Baseline in FPG at Week 12|The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.|Baseline (Week 0) and Week 12|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2846191|NCT00111800|Secondary|Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24|HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values.|Baseline (Week 0) up to Week 24|ITT Population with LOCF dataset was used. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
2846192|NCT00111800|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.|Baseline (Week 0) and Week 12|Intent-to Treat (ITT) Population was defined as all randomized participants who received at least one dose of randomized study medication, had a Baseline assessment and had at least one corresponding on-therapy (scheduled or unscheduled) efficacy assessment. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2846193|NCT00111761|Secondary|Time to Initial Objective Tumor Response (Part 1)|Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response.|||weeks||Inter-Quartile Range|Median
2846194|NCT00111761|Secondary|Time to Treatment Failure (Part 1)|Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||Weeks||95% Confidence Interval|Median
2846195|NCT00111761|Secondary|Survival Time (Part 1)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
2846196|NCT00111761|Secondary|Time to Disease Progression (Part 1)|Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
2846197|NCT00111761|Secondary|Progression-free Survival Time (Part 1)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
2846198|NCT00111761|Secondary|Number of Participants With Objective Tumor Response (Part 1)|Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||Participants|||Number
2846199|NCT00111761|Secondary|Number of Participants Who Died (Part 2)|The number of participants in Part 2 who died during the study.|From enrollment until last contact. Maximum follow-up was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||participants|||Number
2846200|NCT00111761|Secondary|Survival Time (Part 2)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||weeks||95% Confidence Interval|Median
2846201|NCT00111761|Secondary|Progression-free Survival Time (Part 2)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||weeks||95% Confidence Interval|Median
2846202|NCT00111761|Secondary|Time to Disease Progression (Part 2)|Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until death or diease progression. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||weeks||95% Confidence Interval|Median
2846203|NCT00111761|Secondary|Number of Participants With an Objective Tumor Response (Part 2)|Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy|||Participants|||Number
2846204|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)|The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.|||Participants|||Number
2846205|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)|The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy.|||Participants|||Number
2846206|NCT00111657|Secondary|Infusion 1: Minimum Concentration (Cmin)|The lowest drug concentration in the blood after the first infusion of study drug.|21 days after the infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.|||mU/mL||Standard Deviation|Mean
2846207|NCT00111657|Secondary|Infusion 1: Maximum Concentration (Cmax) Value|The highest drug concentration in the blood after the first infusion of study drug.|2 hours|One subject withdrew prior to completing the first infusion and is not included in this analysis.|||mU/mL||Standard Deviation|Mean
2846208|NCT00111657|Secondary|Development of Antibodies to PEG-uricase|Number of patients who developed antibodies to PEG-uricase|baseline, then prior to infusions and 7 wks after last infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.|||participants|||Number
2846209|NCT00111657|Secondary|Reduction of the Ratio of Uric Acid:Creatinine in Urine||baseline then weekly|These data were not calculated because the effect size of serum irate reduction in plasma was so robust that there was no utility in this assessment.||||||
2846210|NCT00111657|Secondary|In a Subset of Subjects Who Volunteer Separately, Change in Uric Acid Pool Size Will be Assessed by a Method That Involves Infusion of Uric Acid Labeled With N15, a Stable (Nonradioactive) Isotope of Nitrogen.||baseline and 7 weeks after last infusion|Data was not collected for this outcome as a result of a separate pilot study demonstrating that the measure was not useful.||||||
2846211|NCT00111657|Secondary|Clinical Response: Number of Swollen and Tender Joints|Count of tenderness and swelling of 68 joints|Basline and day 134|30 subject assesed at baseline. 21 subjects who completed study were assesed at day 134|||joints||Inter-Quartile Range|Median
2846212|NCT00111657|Primary|Reduction in Plasma Uric Acid to Less Than 6 mg/dL.||Baseline to Day 105||||Participants|||Number
2846213|NCT00111475|Secondary|Duration Within the Targeted Therapeutic Platelet Range in Part B|"Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 × 10⁹ cells/L and less than or equal to 450 × 10⁹ cells/L.~Platelet count data after administration of rescue medication were not included in the analysis."|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug and achieved a targeted therapeutic platelet level.|||weeks||Full Range|Median
2846214|NCT00111475|Secondary|Time to Peak Platelet Count in Part B|Platelet count data after administration of rescue medication were not included in the analysis. Time to peak platelet count was analyzed using the Kaplan-Meier method.|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||days||Inter-Quartile Range|Median
2846221|NCT00111475|Secondary|Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B|"Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10⁹ cells/L and less than or equal to 450 x 10⁹ cells/L.~Platelet count data after use of rescue medication were not included in the analysis."|Day 1 to day 78|Participants randomized in Part B who received at least 1 dose of study drug.|||percentage of participants|||Number
2846222|NCT00111475|Secondary|Duration Within the Targeted Therapeutic Platelet Range In Part A|"Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and ≥ 50 and ≤ 450 × 10⁹ cells/L.~Platelet count data after the use of rescue medication were not included."|After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim and with a platelet count ≥ 50 × 10⁹ cells/L and ≤ 450 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication.|||days||Standard Deviation|Mean
2846223|NCT00111475|Secondary|Time to Peak Platelet Count After Each Dose in Part A|Platelet count data after the use of rescue medication were not included.|After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication.|||days||Full Range|Median
2846224|NCT00111475|Secondary|Change From Baseline in Peak Platelet Count After Each Dose in Part A|Platelet count data after the use of rescue medication were not included.|Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication.|||1 × 10⁹ cells/L||Standard Deviation|Mean
2846225|NCT00111475|Secondary|Peak Platelet Count After Each Dose in Part A|Platelet count data after the use of rescue medication were not included.|After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication.|||1 × 10⁹ cells/L||Standard Deviation|Mean
2846226|NCT00111475|Secondary|Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A|Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.|After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim|||Participants|||Count of Participants
2846227|NCT00111475|Secondary|Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A|Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.|After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim|||Participants|||Count of Participants
2846228|NCT00111475|Secondary|Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A|Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders.|After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim|||Participants|||Count of Participants
2846229|NCT00111475|Secondary|Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A|"Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and between 50 to 450 x 10⁹ cells/L.~Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders."|After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78)|Participants enrolled in Part A who received each dose of romiplostim.|||Participants|||Count of Participants
2846230|NCT00111475|Primary|Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies|The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported.|Assessed on day 29 (Part A only), day 43 (Part B only), and day 78|All treated participants|||Participants|||Count of Participants
2846231|NCT00111475|Primary|Number of Participants With Adverse Events||From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days|All treated participants|||Participants|||Count of Participants
2846232|NCT00111241|Secondary|Knee Subchondral Bone Expansion|change in subchondral bone expansion area over two years|Baseline, Two years||||mm²||Standard Deviation|Mean
2846233|NCT00111241|Primary|Knee Cartilage Volume|change in medial and lateral articular tibial cartilage volume over two years|Baseline, two years||||mm³||Standard Deviation|Mean
2846234|NCT00111228|Secondary|Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline|Average blood glucose - change from baseline to end of 3 month study period, calculated as average blood glucose at 3 month - average blood glucose at baseline|baseline and 3 month after study||||mg/dL||Standard Deviation|Mean
2846235|NCT00111228|Primary|Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period|Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline|baseline and 3 month after study||||percentage of HbA1C||Standard Deviation|Mean
2846256|NCT00110812|Post-Hoc|Commencement of Continuous Antiretroviral Treatment|Number of patients commencing continuous antiretroviral treatment.|from randomization through February 28, 2011, the end of the extension phase|All randomized patients are counted. Patients who did not consent to the extension phase are censored at the end of the main study (Feb 28, 2009). Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||participants|||Number
2846321|NCT00110357|Secondary|Maximum Plasma Concentration (Cmax)|The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||µg/mL||Standard Deviation|Geometric Mean
2846236|NCT00111007|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)|Change in ECOG PS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||participants|||Number
2846237|NCT00111007|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 197 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||Full Range|Median
2846238|NCT00111007|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 126 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||95% Confidence Interval|Median
2846239|NCT00111007|Secondary|Overall Survival (OS)|Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (median time of 294 days)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||95% Confidence Interval|Median
2846240|NCT00111007|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (median time of 124 days)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.|||days||95% Confidence Interval|Median
2846241|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
2846242|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
2846243|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
2846257|NCT00110812|Post-Hoc|Undetectable HIV-RNA|Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.|24 months post-trial|All patients for whom an HIV-RNA measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||participants|||Number
2846244|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||scores on a scale||Standard Deviation|Mean
2846245|NCT00110994|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||participants|||Number
2846246|NCT00110994|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 188 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
2846247|NCT00110994|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 148 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
2846248|NCT00110994|Secondary|Number of Participants in Tumor Response Categories|Tumor response was defined as the best response (confirmed complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD. CR: Disappearance of all target lesions. SD: Does not qualify for CR or PR. PD: at least a 20% increase in SLD taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions.|Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||participants|||Number
2846249|NCT00110994|Secondary|Overall Survival (OS)|Overall Survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (the maximum treatment duration of 71.1 weeks)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
2846250|NCT00110994|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.|||days||95% Confidence Interval|Median
2846251|NCT00110890|Secondary|Number of Participants With Mean Serum P < 5.5 mg/dL|Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
2846252|NCT00110890|Secondary|Number of Participants With Mean Serum Ca < 9.5 mg/dL|Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
2846253|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
2846254|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assesment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)|||Participants|||Number
2846259|NCT00110812|Post-Hoc|Opportunistic Disease or Death During the Trial Extension Phase|Incidence of an opportunistic event (AIDS-defining infection or malignancy) or death between February 28, 2009, when the main study ended, and February 28, 2011, when the extended phase was completed.|two years following close of main study|All patients who were alive at the end of the main study and who consented to be followed for an additional 2 years in the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.|||participants|||Number
2846260|NCT00110812|Secondary|SGOT|Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal|week 32|all patients with SGOT measured at week 32|||participants|||Number
2846261|NCT00110812|Secondary|Thyroid Stimulating Hormone|Number of participants with thyroid stimulating hormone greater than the upper limit of normal|week 32|all patients with TSH measured at 32 weeks|||participants|||Number
2846262|NCT00110812|Secondary|Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12||month 12|patients for whom HIV-RNA measurement was available at baseline and month 12.|||copies/ml (log 10)||Standard Deviation|Mean
2846263|NCT00110812|Secondary|Initiation of Continuous ART|While patients were not taking ART at baseline or while undergoing IL-2 cycles (other than use of pericycle ART in one of the three groups), some chose to start an ART regimen during the study.|from randomization through February 28, 2009|all patients randomized|||participants|||Number
2846264|NCT00110812|Secondary|Disease Progression or Death|occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death|throughout study, through Feb 28 2009 (median followup of 19 months)|all randomized patients|||participants|||Number
2846265|NCT00110812|Secondary|Fasting Lipid Profile|total fasting cholesterol|week 32|all patients with laboratory data at week 32 who reported fasting|||mg/dl||Standard Deviation|Mean
2846266|NCT00110812|Secondary|HIV-1 Genotype Changes|Patients who developed mutations associated with antiretroviral drugs.|after 3rd cycle of IL-2|Per protocol, the analysis of genotypic changes associated with antiretroviral resistance was restricted patients in one arm, namely, patients assigned to take pericycle HAART who completed 3 cycles of IL-2 and who had successful genotypes.|||participants|||Number
2846267|NCT00110812|Secondary|Change in CD4 T Lymphocyte Count|change from baseline to month 12 in CD4 T lymphocyte count|At Month 12|patients for whom the month 12 CD4 count was available|||cell/mm^3||Standard Deviation|Mean
2846268|NCT00110812|Secondary|Plasma HIV RNA|change from baseline in HIV-RNA copies/ml (log10)|At Week 32|Patients for whom HIV-RNA was available at week 32|||copies/ml (log 10)||Standard Deviation|Mean
2846269|NCT00110812|Secondary|Discontinuation of IL-2|Patients receiving fewer than 3 cycles of IL-2 by week 32|week 32|all patients randomized to a study arm containing IL-2|||participants|||Number
2846270|NCT00110812|Primary|Mean Change in CD4+ T Lymphocyte Count|Change in CD4 count from baseline to week 32.|Week 32|patients for whom the week-32 CD4+ cell count was measured|||cell/mm^3||Standard Deviation|Mean
2846271|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 104 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had assessment of serum ferritin at Start of ICL670 treatment and at 104 weeks.|||mg/mL||95% Confidence Interval|Least Squares Mean
2846272|NCT00110617|Primary|The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment|The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks.|24 Weeks|Safety-1 set: All participants, except participants enrolled in Center 512, who received at least one dose of study medication during the first 24 weeks.|||participants|||Number
2846273|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had an assessment of serum ferritin at Start of ICL670 treatment and at 24 weeks or 52 weeks.|||mg/mL||95% Confidence Interval|Least Squares Mean
2846274|NCT00110617|Secondary|Absolute Change in Serum Ferritin From Baseline to Week 24|Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood.|Baseline, 24 Weeks|Per protocol- 1 defined as all participants who had study drug and had an assessment of serum ferritin at Baseline and at Week 24.|||mg/mL||95% Confidence Interval|Least Squares Mean
2846275|NCT00110513|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)|To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.|During treatment and follow up period of 7 days|Intent to treat population|||Participants|||Number
2846276|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846277|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846278|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous week, only randomized subjects who had both previous week and at least next week were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846279|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846280|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846281|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846282|NCT00110461|Secondary|Subject Response to Treatment at Week 30|"Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.|||percentage of participants|||Number
2846283|NCT00110461|Secondary|Subject Response to Treatment at Week 4|"Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.|||percentage of participants|||Number
2846322|NCT00110357|Secondary|Number of Participants With a Dose-Limiting Toxicity|Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD).|Prior to each 21-day cycle until dose-limiting toxicities|All treated subjects|||Participants|||Number
2848331|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mcg/L||Standard Error|Mean
2846284|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30|"Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846285|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846286|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4|Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846287|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30|Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846288|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846289|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846290|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846445|NCT00109031|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|Up to Day 28|Primary analysis set|||participants|||Number
2846291|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846292|NCT00110461|Secondary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30|Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846293|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846294|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846295|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846296|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846297|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846332|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 240 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
2846298|NCT00110461|Secondary|Change in Children's Global Assessment (CGAS) Total Score at Week 30|"Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846299|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4|Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846300|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846301|NCT00110461|Secondary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4|Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846302|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846303|NCT00110461|Secondary|Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4|"Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846304|NCT00110461|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30|"Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846346|NCT00110136|Secondary|Estimation of Toxicities While on St. John's Wort|Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.|Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)|All registered participants|||percentage of participants||95% Confidence Interval|Number
2848332|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
2846305|NCT00110461|Primary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4|"Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects be different number subjects included in the efficacy analysis.|||points||Standard Deviation|Mean
2846306|NCT00110396|Secondary|Number of Participants With Binding Antibodies (BAb) at Week 96|Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).|96 weeks|ITT (One participant did not have any post-baseline NAb assessments) LOCF imputation|||Participants|||Number
2846307|NCT00110396|Secondary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation|||participants|||Number
2846308|NCT00110396|Primary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation|||participants|||Number
2846309|NCT00110357|Secondary|Grade 3/4 Laboratory Abnormalities - Hypomagnesemia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
2846310|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Thrombocytopenia|Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
2846311|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Neutropenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
2846312|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Leukopenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment||||Participants|||Number
2846313|NCT00110357|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan|MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)|Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.|As-treated population|||mg/m2|||Number
2846314|NCT00110357|Secondary|Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)|Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening.|Weekly throughout the study and every 4 weeks thereafter|All treated patients|||Participants|||Number
2846315|NCT00110357|Secondary|Human Anti-cetuximab Antibody (HACA) Response|In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value > 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level.|Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle|Cohort comprises all enrolled participants who were tested for HACA. Evaluable participants had normal baseline HACA (≤ 7 ng/dL) and ≥1 postbaseline HACA levels; unevaluable participants either did not have enough sample for analysis or did not have a pre- and postinfusion sample for immunogenicity.|||Participants|||Number
2846316|NCT00110357|Secondary|Tumor Response|"Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve (respond), stay the same (stable), or worsen (progression). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam."|Every other 21-day cycle|All treated subjects|||Participants|||Number
2846317|NCT00110357|Secondary|Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||L/m2||Standard Deviation|Mean
2846318|NCT00110357|Secondary|Clearance Corrected for Body Surface Area (CL/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||L/h/m2||Standard Deviation|Mean
2846319|NCT00110357|Secondary|Terminal Half-Life (T-Half)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||hours||Standard Deviation|Mean
2846320|NCT00110357|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF])|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study||||µg•h/mL||Standard Deviation|Geometric Mean
2846323|NCT00110305|Secondary|Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles|Quartile 1, 2, 3 and 4 of AUC24h means the quartile with the lowest 25%, 26-50%, 51-75% and the highest 25% of AUC24h values, respectively, irrespective of the different doses of TMC278. For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. Virologic response was calculated by time to loss of virologic response (TLOVR) algorithm.|Up to Week 96|Analysis included participants who received TMC278 with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter. Participants who discontinued treatment for reasons other than virological failure were excluded from this analysis.|||Participants|||Number
2846324|NCT00110305|Secondary|Trough Plasma Concentration (Ctrough) for TMC278|For each participant, a single value for trough (i.e. predose) plasma concentration (Ctrough) of TMC278 was estimated from a population pharmacokinetic model, based on samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter.|||ng/mL||Standard Deviation|Mean
2846325|NCT00110305|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278|For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharmacokinetic samples in order to derive population pharmacokinetic parameter.|||ng*h/mL||Standard Deviation|Mean
2846326|NCT00110305|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as a viral load greater than 0.5 log10 copies /mL above the nadir with a minimum of 500 copies/mL. For this study, treatment-emergent mutations (for at least one treatment) are presented as Resistance associated mutation (RAMs): i) Non-nucleotide reverse transcriptase inhibitor (NNRTI) RAMs, ii) Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
2846327|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Percentage of CD4+ cells||Standard Deviation|Mean
2846328|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Cells per microliter||Standard Deviation|Mean
2846329|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat (ITT) population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.|||Percentage of CD4+ Cells||Standard Deviation|Mean
2846330|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.|||Cells per microliter||Standard Deviation|Mean
2846331|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
2846387|NCT00109772|Secondary|Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12|Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.|||units on a scale||Standard Deviation|Mean
2846333|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.|||Participants|||Number
2846334|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 96 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.|||Participants|||Number
2846335|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.|||Participants|||Number
2846336|NCT00110305|Primary|Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 48|Intent to treat population: Participants who received at least 1 dose of study medication.|||Participants|||Number
2846337|NCT00110214|Secondary|Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities|"The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death"|During treatment (up to 2 years)|Participants who did not received allocated intervention were excluded from toxicity analysis.|||percentage of participants|||Number
2846338|NCT00110214|Secondary|Progression-free Survival (PFS)|"PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
2846339|NCT00110214|Secondary|Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline|PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy.|Duration of study (up to 5 years)||||percentage of participants|||Number
2846340|NCT00110214|Primary|Overall Survival|Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
2846341|NCT00110149|Primary|EFS|Event = Death, second malignancy , disease progression.|1 year|The study was terminated early|||Participants|||Count of Participants
2846342|NCT00110149|Primary|Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks|"INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA~Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53."|14 weeks|The trial closed prematurely secondary to the company that produced the agent being sold to another company and the agent not being available to treat the full number of patients in this trial.|||Participants|||Count of Participants
2846343|NCT00110136|Secondary|Mood is Measured by the POMS Short Form.|"POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions).~Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better.~The range is 0 to 68.~Higher scores represent better overall mood."|Baseline and four weeks|All registered participants.|||units on a scale||Standard Deviation|Mean
2846344|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (PCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS.~SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.~PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health.~The range is 0 to 100.~Higher scores represent better mental health."|Baseline and four weeks|All registered participants.|||units on a scale||Standard Deviation|Mean
2846345|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (MCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS.~SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.~MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health.~The range is 0 to 100.~Higher scores represent better mental health."|Baseline and four weeks|All registered participants.|||units on a scale||Standard Deviation|Mean
2846347|NCT00110136|Secondary|Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|"The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week.~Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days.~Score ranges from 0 to infinity~Lower scores are better."|Baseline and four weeks|All registered participants|||frequency times severity||Standard Deviation|Mean
2846348|NCT00110136|Primary|Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort|Baseline and four weeks|All registered participants|||number of occurrences||Standard Deviation|Mean
2846349|NCT00110084|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 6 weeks||||participants|||Number
2846350|NCT00110084|Secondary|Overall Survival|Overall survival time was defined as the number of days from registration to the date of death or last follow-up|Death or last follow-up (up to 5 years)|Median survival time from Kaplan-meir estimate has not been attained.|||months||95% Confidence Interval|Median
2846351|NCT00110084|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 5 years)||||months||95% Confidence Interval|Median
2846352|NCT00110084|Primary|Proportion of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart|per protocol|||participants|||Number
2846353|NCT00110019|Secondary|Objective Response (Complete and Partial Response) Rate|Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.|Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.|Intention-to-treat population, n=823|||proportion||95% Confidence Interval|Number
2846354|NCT00110019|Secondary|Progression-free Survival|Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.|Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis|||months||95% Confidence Interval|Median
2846355|NCT00110019|Primary|Overall Survival|Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.|Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.|Intention-to-treat population, n=823|||months||95% Confidence Interval|Median
2846356|NCT00109967|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed for survival status for up to 5 years.||||months||95% Confidence Interval|Median
2846357|NCT00109967|Secondary|Toxicity|"As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.~In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event."|Assessed during treatment (up to 12, 28-day cycles)||||patients|||Number
2846358|NCT00109967|Secondary|Duration of Response|Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Response duration is followed up to 5 years from registration.|Of the 48 Rituximab Sensitive patients, 30 patients had a response. Of the 21 Rituximab Refractory patients, 11 patients had a response. Therefore, this endpoint uses 30 patients from the Rituximab Sensitive group and 11 patients from the Rituximab Refractory group in the analysis.|||months||95% Confidence Interval|Median
2846359|NCT00109967|Secondary|Time to Progression|Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed up to five years after registration.||||months||95% Confidence Interval|Median
2846360|NCT00109967|Primary|Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria|"Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.~Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.~Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.~We report the Overall Response Rate here."|Up to 12, 28-day cycles.||||percentage of patients||95% Confidence Interval|Number
2846604|NCT00107172|Secondary|Number of Participants Reported Regional Recurrence at 3 Years|Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.|3 years|All intent-to-treat participants.|||participants|||Number
2846361|NCT00109928|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 18 weeks of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2846362|NCT00109928|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|up to 3 years or time of disease progression|All eligible patients who started protocol treatment were included in the analysis.|||participants|||Number
2846363|NCT00109928|Secondary|2-year Progression-free Survival Rate|Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.|0-2 years|All eligible patients who started protocol treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2846364|NCT00109928|Primary|2-year Overall Survival Rate|The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.|0-2 years|All eligible patients who started protocol treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2846365|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 24|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.|Baseline and Month 24|All enrolled participants who met the eligibility criteria.|||Participants|||Count of Participants
2846366|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 3|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.|Baseline and Month 3|All enrolled participants who met the eligibility criteria.|||Participants|||Count of Participants
2846367|NCT00109876|Secondary|Incidence of Adverse Events|The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event. > Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||Participants|||Count of Participants
2846368|NCT00109876|Secondary|Number of Procedures Deemed Technical Successes|The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||number of technical successes|||Number
2846369|NCT00109876|Secondary|Overall Time to Recurrence|The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||years||95% Confidence Interval|Median
2846370|NCT00109876|Secondary|Overall Time to Local Failure|The overall time to local failure was defined as the time from registration to documentation of > local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.|Up to 2 years|All enrolled participants who met the eligibility criteria.|||years||95% Confidence Interval|Median
2846371|NCT00109876|Primary|Overall Survival at 2 Years|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration|All enrolled participants who met the eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2846372|NCT00109850|Secondary|Progression Free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 5 years|All eligible patients who started treatment were included in the analysis.|||months||95% Confidence Interval|Median
2846373|NCT00109850|Secondary|Objective Response (Confirmed and Unconfined, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|at week 16, then every 3 months until progression|All eligible patients who started treatment and were evaluable for response were included in assessing response estimates.|||percentage of participants||95% Confidence Interval|Number
2846417|NCT00109473|Secondary|Height Velocity|"Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.~It is calculated by measuring height at two points of time and then dividing the change by the amount of time."|Baseline, week 12, 24 and 48||||cm/year||Standard Error|Mean
2846374|NCT00109850|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every two cycles of chemotherapy.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2846375|NCT00109850|Primary|Overall Survival at 2 Years|Measured from time of registration to date of death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2846376|NCT00109837|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events after the induction cycle|Eligible patients who started therapy|||Participants with a given type of AE|||Number
2846377|NCT00109837|Primary|Continuous Complete Remission at 1 Year|A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.|After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year|Eligible, Ph-, treated, and evaluable patients|||participants|||Number
2846378|NCT00109772|Secondary|Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period|"Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.~AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above."|Day 1 up to week 158|Safety population|||participants|||Number
2846379|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.|||meters/second||Standard Deviation|Mean
2846380|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.|||meters/second||Standard Deviation|Mean
2846381|NCT00109772|Secondary|Participants Who Had a Change to CRPS Pain Medication During the Treatment Period|Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s).|Day 1 to week 12|Intent to treat population|||participants|||Number
2846382|NCT00109772|Secondary|Patient Global Impression of Change (PGIC) at Week 12|The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better.|Week 12|Intent to treat. Forty-five participants had no week 12 values.|||units on a scale||Standard Deviation|Mean
2846383|NCT00109772|Secondary|Change From Baseline in the Profile of Mood States (POMS) at Week 12|Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Six participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846384|NCT00109772|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12|Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846385|NCT00109772|Secondary|Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12.|Week 12|Intent to treat population. Last observation carried forward. Fifteen participants were missing values.|||units on a scale||Standard Deviation|Mean
2846386|NCT00109772|Secondary|"Change From Baseline in Mechanically Evoked (Allodynia) Numeric Rating Scale (NRS) Score at Week 12"|The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.|||units on a scale||Standard Deviation|Mean
2846418|NCT00109473|Secondary|Crohn's Disease Endoscopic Index of Severity (CDEIS)|Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline and 12 weeks||||Scores on a scale||95% Confidence Interval|Mean
2846388|NCT00109772|Secondary|Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12|Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846389|NCT00109772|Secondary|Change From Baseline in Daily Sleep Assessment Average Score at Week 12|Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846390|NCT00109772|Secondary|Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846391|NCT00109772|Secondary|Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846392|NCT00109772|Secondary|Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846393|NCT00109772|Secondary|Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12|Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat. Last observation carried forward. Three participants had no post-treatment values.|||units on a scale||Standard Deviation|Mean
2846394|NCT00109772|Primary|Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.|Day 0, Week 12|Intent to treat|||percentage of participants|||Number
2846395|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
2846396|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Limb Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
2846397|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Total Body Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
2846398|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Lean Body Mass||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
2846399|NCT00109733|Primary|Percent Change From Baseline to Week 24 in Trunk Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward|||percent change||Standard Deviation|Mean
2846400|NCT00109590|Primary|Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug/mL||Full Range|Median
2846401|NCT00109590|Primary|Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug/mL||Full Range|Median
2846419|NCT00109473|Secondary|Total Corticosteroid Use||12 weeks, 24 weeks|||||||
2846402|NCT00109590|Primary|Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug/mL||Full Range|Median
2846403|NCT00109590|Secondary|Median HIV-1 Viral Load at 24 Weeks Postpartum in Women||at 24 weeks postpartum|The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.|||log10 copies/mL||Full Range|Median
2846404|NCT00109590|Secondary|Resistance Mutations in HIV Infected Infants|Resistance mutations as identified by consensus sequencing or OLA|24 weeks postpartum|Amongst the infants who became HIV-infected.|||participants|||Number
2846405|NCT00109590|Secondary|Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.|Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.|within 72 weeks postpartum|amongst the participants who developed resistance within 8 weeks postpartum|||participants|||Number
2846406|NCT00109590|Secondary|Number of Women With Grade >=3 Events After Start of Study Treatment|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.|After start of study Treatment (postpartum)|All women who started treatment were included in an intention-to-treat analysis.|||participants|||Number
2846407|NCT00109590|Secondary|The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.||At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).|All women who started treatment were included in an intention-to-treat analysis|||percent of participants|||Number
2846408|NCT00109590|Secondary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|Includes only the Subgroup of women with Plasma HIV RNA >= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).|||percent of participants||95% Confidence Interval|Number
2846409|NCT00109590|Primary|Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.|||ug*hr/mL||Full Range|Median
2846410|NCT00109590|Primary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)|||percent of participants||95% Confidence Interval|Number
2846411|NCT00109590|Primary|The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).|The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.|within 8 weeks postpartum.|All women who started treatment were included in an intention-to-treat analysis.|||percent of participants||95% Confidence Interval|Number
2846412|NCT00109577|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)||Baseline to 8 weeks|||||||
2846413|NCT00109577|Secondary|Outcome Questionnaire --- a Self-report Questionnaire||Baseline to 8 weeks|||||||
2846414|NCT00109577|Secondary|Global Clinical Impressions||Baseline to 8 weeks|||||||
2846415|NCT00109577|Primary|Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)|Change in mood from baseline to final visit, as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale); minimum possible score is 0 and maximum possible score is 103; higher scores mean worse symptomatology|Baseline to 8 weeks|All participants were included, since the analysis was intent-to-treat with last observation carried forward|||units on a scale||Standard Deviation|Mean
2846416|NCT00109473|Secondary|Fecal Calprotectin|Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.|At 24 and 64 weeks||||micrograms per gram (microg/g)||95% Confidence Interval|Mean
2846420|NCT00109473|Secondary|Pediatric Crohn's Disease Activity Index (PCDAI)|The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.|Baseline, 12 and 24 weeks||||Scores on a scale||95% Confidence Interval|Mean
2846421|NCT00109473|Secondary|IMPACT III Score|Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.|Baseline, 12 weeks, 24 weeks||||Scores on a scale||95% Confidence Interval|Mean
2846422|NCT00109473|Secondary|Serum IGF-1 (Insulin-like Growth Factor 1)z Score|"Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.~The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean."|Baseline, 12 weeks, 24 weeks||||Z score||Standard Error|Mean
2846423|NCT00109473|Primary|Crohn's Disease Histologic Index of Severity (CDHIS)|The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16|Baseline and 12 weeks||||scores on a scale||95% Confidence Interval|Number
2846424|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846425|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846426|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846427|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846428|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846429|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846430|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
2846431|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846432|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846433|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846434|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846435|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846436|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846437|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
2846438|NCT00109343|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||Participants|||Number
2846439|NCT00109343|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
2846440|NCT00109343|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
2846441|NCT00109343|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
2846442|NCT00109031|Secondary|Number of Participants With WHO Grade 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set|||participants|||Number
2846443|NCT00109031|Secondary|Duration of WHO Grade 2, 3 or 4 Oral Mucositis|"The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study.~OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|Up to Day 28|Primary analysis set with available OM assessment data|||days||Standard Deviation|Mean
2846444|NCT00109031|Secondary|Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set|||participants|||Number
2849215|NCT00089102|Secondary|Number of Participants Who Experienced SAEs on Study||From the day of first dose until the end of study, for an average of 6 months||||Participants|||Count of Participants
2846446|NCT00109031|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS."|From the first day of study drug administration through Day 28|Primary analysis set with available MTS data|||MTS score * days||Standard Deviation|Mean
2846447|NCT00109031|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to Day 28|Primary analysis set|||days||Standard Deviation|Mean
2846448|NCT00109031|Primary|Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set|||participants|||Number
2846449|NCT00109005|Secondary|Evaluate Effects of Lenalidomide on Pathways|Tissue will be obtained to evaluate the effects of lenalidomide on pathways thought to be modulated by lenalidomide.|Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.|This outcome measure was not analyzed because the investigator left the institution.||||||
2846450|NCT00109005|Secondary|Determine Dose Level With Superior Efficacy and Acceptable Toxicity|The most efficacious dose (with greater number of responses) with acceptable toxicity profile will be considered for use in subsequent trials. iI the number of responses is tied, then toxicity criteria (Common Terminology criteria (CTC) v3.0) will be used to select the preferred dose.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.||||||
2846451|NCT00109005|Secondary|Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg|Plasma samples will be obtained and plasma concentrations will be determined by a reversed-phase high-performance liquid chromatography (HPLC) assay using mass spectrometry (MS) detection.|Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.|This outcome measure was not analyzed because the investigator left the institution.||||||
2846452|NCT00109005|Secondary|Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.||||||
2846453|NCT00109005|Secondary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.||||||
2846454|NCT00109005|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|24 months||||Participants|||Number
2846455|NCT00109005|Primary|Clinical Responses in Patients With Metastatic Ocular Melanoma|Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 months|"Response data was combined for this outcome measure. Results are available for the combined cohorts only.~Sixteen out of seventeen patients were eligible for response assessments."|||Participants|||Number
2846456|NCT00108953|Secondary|Percentage of Participants for Whom Disease Control Was Achieved|Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)|from date of randomization to end of treatment plus 30 days|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||Percentage of participants|||Number
2846457|NCT00108953|Secondary|Time to Response (TTR)|Time from date of randomization to date of first objective response (complete response [CR] or partial response [PR]) is documented and confirmed according to RECIST criteria|from date of randomization until 3 years later at end of study|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||Full Range|Median
2846458|NCT00108953|Secondary|Duration of Response|Time from date of first objective response (complete response [CR] or partial response [PR]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||Full Range|Median
2846459|NCT00108953|Secondary|Time to Symptomatic Progression (TTSP)|Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||95% Confidence Interval|Median
2846472|NCT00108862|Secondary|Percent of Participants Reporting a Grade 3 or 4 Adverse Event or Laboratory Abnormality|All eligible participants were included in this analysis. The percent of participants whose highest reported grade of adverse events and laboratory abnormalities was Grade 3 or 4 was calculated with an associated standard error, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening/disabling, and Grade 5=death.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846460|NCT00108953|Secondary|Percentage of Participants in Each Category of Best Tumor Response|Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|achieved during treatment or within 30 days after termination of active therapy|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||Percentage of participants|||Number
2846461|NCT00108953|Secondary|Progression Free Survival (PFS)|Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.|||days||95% Confidence Interval|Median
2846462|NCT00108953|Secondary|Overall Survival|The time from date of randomization to date of death|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients. The table below gives the lower and upper limit of the confidence interval; 999999999 = not estimable.|||days||95% Confidence Interval|Median
2846463|NCT00108953|Primary|Time to Progression (TTP)|TTP was defined as the time from randomization to radiological disease progression by independent assessment.|from date of randomization of the first patient until 3 years later|The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients.|||days||95% Confidence Interval|Median
2846464|NCT00108862|Secondary|Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a HIV viral load at least 400 copies/mL were grouped separately those those who died or who had HIV viral loads below 400 copies/mL. Participants missing HIV viral loads at week 48 were coded as LFU in this analysis. Percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846465|NCT00108862|Secondary|Percent of Participants With HIV IRIS.|All eligible participants were included in this analysis. The percent of participants with HIV-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846466|NCT00108862|Secondary|Percent of Participants With MTB IRIS.|All eligible participants were included in this analysis. The percent of participants with Mycobacteria tuberculosis (MTB)-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846467|NCT00108862|Secondary|Percent of Participants Whose CD4 Increased by at Least 100 Cells/mm^3 Between Baseline and Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a CD4 cell count increase of less than 100 cells/mm^3 were grouped separately those who died or whose CD4 cell count increased by at least 100 cells/mm^3. Participants missing CD4 cell counts at week 48 were coded as LFU in this analysis. The percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846468|NCT00108862|Secondary|Percent of Participants With Confirmed or Probable Tuberculosis (TB) Whose TB Resolved, or Who Required TB Treatment Through the End of Follow-up, or Died, or Were Lost to Follow-up.|TB treatment outcome was assessed in the 800 eligible participants who had confirmed or probable TB at study entry. The sites determined if the TB was resolved. If TB was not resolved, TB treatment outcome status was determined based on whether TB treatment was ongoing at the last study visit; if the participant died while TB treatment was ongoing; or if the participant was lost to follow-up, withdrew consent, or other reason for lacking TB resolution status. Percents were calculated with associated standard errors.|Through week 48|Participants with confirmed or probable TB at study entry were included in this analysis. Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846469|NCT00108862|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One Tuberculosis (TB) Medication Due to Toxicity.|All eligible participants were included in this analysis. The percent of participants who interrupted at least one TB medication for more than one day due to toxicity or discontinued at least one TB medication due to toxicity was calculated with an associated standard error.|Through week 48||||percent of participants||95% Confidence Interval|Number
2846470|NCT00108862|Secondary|Percent of Participants With Culture-confirmed Tuberculosis (TB) Who Survived Without AIDS Progression.|This analysis was based on 374 participants with culture-confirmed TB at entry. The percent with culture-confirmed TB surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846471|NCT00108862|Secondary|Time to First New AIDS-defining Illness or Death.|All eligible participants were included in this analysis. Weeks from randomization to first new AIDS-defining illness or death was analyzed using a stratified Cox proportional hazards regression model. The stratification was by screening CD4 cell count: <50 cells/mm3 versus =>50 cells/mm3.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||weeks||95% Confidence Interval|Number
2846485|NCT00108628|Secondary|Nightmare Effects Survey|This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2846473|NCT00108862|Other Pre-specified|Percent of Participants in the Greater Than or Equal to 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the =>50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846474|NCT00108862|Other Pre-specified|Percent of Participants in the Less Than 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the <50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846475|NCT00108862|Primary|Percent of Participants Who Survived Without AIDS Progression.|As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).|||percent of participants||95% Confidence Interval|Number
2846476|NCT00108732|Secondary|The Difference Between PSA Slopes Before and After Treatment|PSA slopes were assessed by multiple PSA values obtained prior to registration and during treatment. Only patients who completed at least 3 months of treatment were included in this analysis. The PSA slopes were calculated by a piecewise linear model using the three or four PSA values obtained prior to registration and PSA measurements obtained every 4 weeks for the first six months of treatment. Natural log transformed PSA levels were used in this analysis, and the difference between PSA slopes before and after treatment was calculated.|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only 31 patients who completed at least 3 months of treatment were included in this analysis.|||log PSA/month||Full Range|Median
2846477|NCT00108732|Secondary|Difference Between Day 4 PSA Level and Day 15 PSA Level|PSA level was assessed on Day 4 and Day 15 of cycle 1, and a comparison between the two measurements was done.|Assessed at day 4 and day 15 of cycle 1|Only 22 patients with both day 4 and day 15 PSA levels available were included in this analysis.|||ng/mL||Full Range|Median
2846478|NCT00108732|Secondary|Proportion of Patients With PSA Response|"PSA response is defined as complete biochemical response or partial response.~Complete Response:~A PSA < 0.2 ng/mL confirmed by a repeat PSA one month later is considered a complete biochemical response for patients with prior radical prostatectomy. A PSA < 1 ng/mL on three separate occasions taken at least one month apart is considered a complete biochemical response in patients with radiation therapy only.~Partial Response:~A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only eligible and treated patients in step I are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
2846479|NCT00108732|Primary|Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)|"For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater.~Changes in PSA below 5 ng/mL will not be considered assessable for progression.~For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL."|Assessed at 6 months|Only eligible and treated patients in step I are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
2846480|NCT00108628|Secondary|Clinician-Administered PTSD Scale (CAPS)|Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.|Baseline and 1 month post-treatment||||units on a scale||Standard Deviation|Mean
2846481|NCT00108628|Secondary|SF-36 Mental Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2846482|NCT00108628|Secondary|SF-36 Physical Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2846483|NCT00108628|Secondary|Beck Depression Inventory|Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2846484|NCT00108628|Secondary|PTSD Military Checklist|Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.|Baseline and 1, 3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
2846490|NCT00108550|Secondary|Roland and Morris Disability Index Scores Adjusted for Time|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Randomized participants who received one dose of study drug|||units on a scale||95% Confidence Interval|Mean
2846491|NCT00108550|Primary|Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time|"Self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Analysis of all randomized participants receiving study drug|||units on a scale||95% Confidence Interval|Mean
2846492|NCT00108524|Secondary|Change From Baseline in Blood Sugar at 48 Weeks|Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.|Baseline and 48 weeks||||mg/dL||95% Confidence Interval|Mean
2846493|NCT00108524|Secondary|Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks|Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.|baseline and 48 weeks||||mg/dL||95% Confidence Interval|Mean
2846494|NCT00108524|Primary|Change From Baseline in Body Weight at 48 Weeks|Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.|baseline and 48 weeks||||percentage of weight loss||95% Confidence Interval|Mean
2846495|NCT00108485|Primary|Change in Proteinuria||Baseline, 1 year|Nine participants were enrolled into this study, however baseline data is only available for 2 participants (1 from the Extended Release Niacin arm and 1 from the Placebo arm). Data was only analyzed for 2 participants.|||mg/dL|||Number
2846496|NCT00108433|Secondary|Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization|Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||Percentage of participants|||Number
2846497|NCT00108433|Secondary|Percentage of Pathogens Eradicated|Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||Percentage of Pathogens|||Number
2846498|NCT00108433|Secondary|Number of Participants With Complications During Therapy|Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.|LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||participants|||Number
2846499|NCT00108433|Secondary|Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment|Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.|EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||participants|||Number
2846500|NCT00108433|Primary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.|Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.|||participants|||Number
2846501|NCT00108355|Secondary|Development of Post-paracentesis Circulatory Dysfunction (PCD)|Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day|6 days after paracentesis|Plasma Renin Activity (lab value to measure PCD) was not available for 6 patients leaving 11 patients in Albumin (control group) and 8 patients in Vasoconstrictor (Treatment group) for this outcome analysis.|||participants|||Number
2846502|NCT00108355|Primary|Time to Recurrence of Ascites.|Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)|Variable depending on the patient, average 10 days||||days||Inter-Quartile Range|Median
2846605|NCT00107172|Secondary|Number of Participants Reported Local Recurrence at 3 Years|Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.|3 years|All intent-to-treat participants.|||participants|||Number
2846503|NCT00108342|Primary|Quit Attempts, Use of NRTs, Preference Among NRTs|In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.|At testing, at follow-up|The study was terminated and the data were not analyzed due to the small sample size.||||||
2846504|NCT00108303|Primary|Log of the ODDS of Linkage|Log of the ODDS ratio of Linkage divided by the ODDS of no linkage from a maximum likelihood analysis conducted using the statistical program LINKAGE|1 day|Probands with schizophrenia, their relatives, and controls. The log of the odds ratio summarizes data from the entire study population.|||units on a log scale|||Number
2846505|NCT00108303|Primary|Heritability Coefficient|h squared which ranges from 0 to 1. This number is similar to the more standard Pearson's correlation coefficient, except that the variable, in this case P50 sensory gating, is correlated across the statuses: schizophrenia proband (has the illness), schizophrenia relative (not ill but relative of someone who is), or control (not ill and has no known ill relative, P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds.|5 years|Schizophrenia probands and relatives and controls.|||coefficient|Participants||Number
2846506|NCT00108303|Primary|Genetic Linkage|Log of the Odds for Linkage, a standard genetic analysis metric. The number shown as a result is from a polymorphism in the promoter of the gene for the alpha7 nicotinic receptor on chromosome. Its presence in the individuals in this study, considering all three groups in one analysis, is compared to what of P50 sensory gating. P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds. The log of the odds is the common logarithm of the ratio of the odds that the gene polymorphism and P50 sensory gating are associated versus the odds that they are both distributed in the individuals at random. It is similar to the more common chi squared.|ten years|People with schizophrenia and their relatives in families and controls as members of single families were used to establish the log of the odds ratio.|||log (odds ratio)|||Number
2846507|NCT00108277|Primary|Episodic Anxiety Scale|Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).|1 month||||units on a scale||Standard Deviation|Mean
2846508|NCT00108160|Other Pre-specified|S. Aureus Re-infections (New or Recurrent)|The anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared. S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection. Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.|18 months||||participants|||Number
2846509|NCT00108160|Secondary|Acquisition of New S. Aureus Strains|In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.|18 months|Participants with S. aureus re-infection who acquired a new strain during the 18 month study period.|||participants|||Number
2846510|NCT00108160|Primary|Re-infection With S. Aureus|During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)|18 months|Re-infections with S. aureus, new or recurrent, were noted for all patients enrolled in the study and for patients who completed each study visit.|||participants with S. aureus re-infection|||Number
2846511|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12|Urinary ACR (micrograms per milligram) was determined at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (exponent (mean change on log scale) - 1. [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
2846512|NCT00108082|Secondary|Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12|Plasma lipid concentrations (milligrams per deciliter) were measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent(mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
2846513|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12|CRP concentration (milligrams per deciliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent (mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
2846514|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12|BNP concentration (picagram per milliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (mean change on log scale) -1) [Change is the Month 12 value (or value after 12 months of treatment) minus the Baseline value].|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)|||percentage of change||95% Confidence Interval|Geometric Mean
2846515|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12|Systolic and Diastolic BP were measured at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||mmHg (millimeters of mercury)||Standard Error|Mean
2846516|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||milliliters (mL)||Standard Error|Mean
2846517|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. The ejection fraction is the fraction of the blood volume available at the end of diastole that is pumped out of the ventricules during systole.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||milliliters (mL)||Standard Error|Mean
2846518|NCT00108082|Secondary|Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12|LV filling parameters, LV E-Volume and LV A-Volume, were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. These filling parameters represent the volumes of blood filling the ventricle during the passive filling phase (E-volume) and the active filling phase caused by atrial contraction (A-volume).|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||milliliters (mL)||Standard Error|Mean
2846519|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12|LV Mass was measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams||Standard Error|Mean
2846520|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12|LVMIH was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
2846521|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12|LVMI was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams per meters squared (g/m^2)||Standard Error|Mean
2846522|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12|LV Mass was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams (g)||Standard Error|Mean
2846523|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12|LVMIH was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. LV mass depends on body size. One method of determining whether an individual has LV hypertrophy relates LV mass to height raised to a power of 2.7.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
2846524|NCT00108082|Primary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12|LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)|||grams per meters squared (g/m^2)||Standard Error|Mean
2846525|NCT00108069|Secondary|Adverse Event Grades|The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts.|7.5 years|Neither cohort completed planned accrual and are small in number separately. Additionally, the underlying histological grade would not affect toxicity. Therefore, these cohorts may be combined. The Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs.|||participants|||Number
2846526|NCT00108069|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7.5 years||||Participants|||Number
2846527|NCT00108069|Primary|Response, Defined as Stable Disease or Objective (Partial or Complete) Response.|Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.|Patients were followed for an average of six weeks for assessment of response|Two patients were not able to complete follow-up neuroimaging to assess response due to clinical progression of disease.|||Participants|||Number
2846528|NCT00107991|Secondary|Dermatology Life Quality Index Score (DLQI)|"The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.~Response rates were calculated as the percentage of participants achieving a response."|12 weeks||||Response Rate - % of participants||95% Confidence Interval|Number
2846529|NCT00107991|Secondary|Patient's Pain Score|Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Response rate was calculated as the percentage of patients classified as responders.|12 weeks||||Response Rate - % of participants||95% Confidence Interval|Number
2846530|NCT00107991|Secondary|Patient Global Assessment|"The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:~Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)"|12 weeks||||participants|||Number
2846531|NCT00107991|Primary|50% Reduction in Physician's Global Assessment Score (Percent of Participants)|"Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.~PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease."|12 weeks||||percentage of participants||95% Confidence Interval|Number
2846532|NCT00107991|Secondary|50% Reduction in Number of Lesions (Percent of Participants)|A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.|12 weeks||||percentage of participants||95% Confidence Interval|Number
2846533|NCT00107978|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7 to 14 days after the last antibiotic dose|Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.|||patients|||Number
2846534|NCT00107952|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)~Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to lack of efficacy; Death on or after Day 3 attributable to primary infection~Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.~Indeterminate: Inability to determine outcome"|7 - 14 days following end of antibiotic treatment||||participants|||Number
2846535|NCT00107900|Secondary|Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results|Intent to Treat (ITT) population|end of treatment|ITT population|||seconds||Standard Deviation|Mean
2846536|NCT00107900|Secondary|Change From Baseline for International Normalized Ratio (INR) Results|Intent to Treat (ITT) population|end of treatment|ITT population|||INR ratio||Standard Deviation|Mean
2846538|NCT00107900|Primary|Prevention of Venous Thromboembolism (VTE)|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery).~Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography"|2 weeks|modified ITT population|||percentage of patients with event||90% Confidence Interval|Number
2846539|NCT00107783|Secondary|Change in 6 Minute Walk Test (6MWT)|Change from baseline of the 6MWT at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||ft||Standard Deviation|Mean
2846540|NCT00107783|Secondary|Change in Timed Get up and go|Change from baseline of timed get up and go at 36 months. In timed get up and go, the patient is asked to stand up from a standard chair and walk a distance of 3 meters, turn around and walk back to the chair and sit down. The examiner measures the time it takes for the patient to perform this series of tasks.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||seconds||Standard Deviation|Mean
2846541|NCT00107783|Secondary|Change in Functional Reach Assessment|Change from baseline of functional reach assessment at 36 months. Functional reach assessment measures the difference between the length of a person's outstretched arm and their maximal reach forward, while maintaining balance.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||cm||Standard Deviation|Mean
2846542|NCT00107783|Secondary|Change in Schober's Test|Change from baseline of Schober's test at 36 months. Schober's test measures a patient's ability to flex his/her lower back. The examiner makes a mark at L5 (fifth lumbar vertebra) and places one finger 5 cm below and another finger 10 cm above this mark. The patient is asked to touch his/her toes. The examiner measures the increase in distance between the two fingers.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.|||cm||Standard Deviation|Mean
2846543|NCT00107783|Primary|Change in Total ROM Worse Hip.|Change from baseline in the total (external + internal) hip range of motion (ROM) in the worse hip at 36 months.|Measured at baseline and at 36 months|Intention to treat.|||degrees||Standard Deviation|Mean
2846544|NCT00107744|Secondary|Body Weight at 8 Weeks|Body weight was measured by trained staff using a standard protocol at week 8.|Baseline and 8 Weeks|All participants with body weight measures at each intervention phase|||kg||95% Confidence Interval|Mean
2846545|NCT00107744|Secondary|Change From Baseline in Serum LDL-cholesterol at 8 Weeks|Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.|Baseline and 8 Weeks|All participants with lipid data|||mg/dL||95% Confidence Interval|Mean
2846546|NCT00107744|Primary|Change From Baseline in Average Systolic Blood Pressure at 8 Weeks|The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from 2 baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.|Baseline and 8 Weeks|We conducted analysis according to intention-to-treat principle. All participants with data were included in analysis.|||mmHg||95% Confidence Interval|Mean
2846547|NCT00107653|Secondary|Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities|The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.|||Participants|||Number
2846548|NCT00107653|Secondary|Number of Participants With Marked Abnormal Laboratory Parameters|The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 - 180 g/L, Platelets 150 - 350 10^9/L, White Blood Cell (WBC) 4.5 - 11.0 10^9/L, Lymphocytes 1.00 - 4.80 10^9/L, Neutrophils 1.80 - 7.70 10^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 - 55 U/L, Total bilirubin 0 - 17 μmol/L, Thyroxine T4 58 - 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 - 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 - 506 μmol/L.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment. 'n'=number of evaluable participants available at specified time point.|||Participants|||Number
2846549|NCT00107653|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.|||Participants|||Number
2846550|NCT00107653|Secondary|Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72|The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, [0=worst score (or quality of life) and 100=best score]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.|||Score on a scale||Standard Error|Mean
2846551|NCT00107653|Secondary|Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72|"The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with no fatigue ('0' being the best) and at the other end with greater fatigue ('100' being the worst). Longer distance on the scale from no fatigue indicated greater fatigue. FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale."|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.|||Score on a scale||Standard Error|Mean
2846552|NCT00107653|Secondary|Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score|The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
2846553|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72|Fat scores are categorised as Improved: > 1 category decrease in fat scale; stable: no change in fat scale; worsened: >= 1 category increase in fat scale.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
2846554|NCT00107653|Secondary|Mean Change From Baseline in Fat Score at Week 72|Grading categories for the fat scale were as follows: 1 = <5% hepatocytes; 2 = 6 - 33% hepatocytes; 3 = 34 - 66% hepatocytes; 4 = 67 - 100% hepatocytes.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Score on a scale||Standard Error|Mean
2846555|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score|METAVIR fibrosis score is categorized as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: >= 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
2846556|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score|METAVIR activity scale included activity defines as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: > = 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
2846557|NCT00107653|Secondary|Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72|METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where '0' being 'No activity' and '3' being 'the sever activity'. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; '0' being the best and '4' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Score on a scale||Standard Error|Mean
2846558|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score|Overall ISHAK Fibrosis Score is defined as Improved: >= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: >1 category increase in fibrosis scale.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
2846559|NCT00107653|Secondary|Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where '0' being the best and '6' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.|||Score on a scale||Standard Error|Mean
2846560|NCT00107653|Secondary|Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72|ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: <= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Score on a scale||Standard Error|Mean
2846561|NCT00107653|Secondary|Percentage of Participants With ISHAK Histological Activity Index Response|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: < = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.|||Percentage of participants|||Number
2846562|NCT00107653|Secondary|Percentage of Participants With Biochemical Response|Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L.|At Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
2846563|NCT00107653|Secondary|Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time|The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL.|From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.|||Log10 IU/mL||Standard Error|Least Squares Mean
2846564|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 12|Percentage of participants with an early virologic response defined as an HCV-RNA >=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL).|At Week 12|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
2846565|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 4|Percentage of participants with an early virologic response defined as an HCVRNA >=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL).|At Week 4|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
2846566|NCT00107653|Secondary|Percentage of Participants Achieving Virologic Response|Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)|At Weeks 4, 12, 24, 48, 60, and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
2846567|NCT00107653|Primary|Percentage of Participants With Sustained Virologic Response at Week 72|Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.|At Week 72|Intent-to-Treat (ITT) Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).|||Percentage of participants|||Number
2846568|NCT00107614|Primary|Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)|To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.|3 years||||participant|||Number
2846569|NCT00107575|Primary|Smoking Abstinence at 2 Weeks|7 days of smoking abstinence confirmed biochemically at 2 weeks|2 weeks||||Participants|||Number
2846570|NCT00107575|Primary|Smoking Abstinence at 8 Weeks|7 days of smoking abstinence confirmed biochemically at 8 weeks|8 weeks||||Participants|||Number
2846572|NCT00107575|Secondary|Alcohol Drinks Consumed Per Week Over a 2-week Period|Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.|At 2, 8, 16, and 26-week follow-ups|The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview|||drinks||Standard Deviation|Mean
2846573|NCT00107575|Primary|Smoking Abstinence at 26 Weeks|7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt|26 weeks|For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.|||participants|||Number
2846574|NCT00107536|Secondary|Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways||Up to 3 years||||patients with mutations|||Number
2846575|NCT00107536|Secondary|Target-EGFR/EGFR-P Protein Expression|EGFR (exons 18-21)|Up to 3 years||||patients with somatic mutations|||Number
2846576|NCT00107536|Secondary|Overall Survival||up to 12.6 months||||months||95% Confidence Interval|Median
2846577|NCT00107536|Secondary|Median Overall Survival||Up to 3 years||||months||95% Confidence Interval|Median
2846578|NCT00107536|Secondary|Toxicity Profile Assessed Using NCI CTCAE Version 3.0|Percentage of patients with Adverse events accordng to NCI CTCAE version 3.0|Up to 3 years|All 26 patients were evaluable for toxicity analysis.|||percentage of patients|||Number
2846579|NCT00107536|Secondary|Progression-free Survival||up to 6 months||||months||95% Confidence Interval|Median
2846580|NCT00107536|Primary|Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST|PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.|Up to 3 years|Only 25 patients were evaluable for response (1 patient passed away before staging).|||patients|||Number
2846581|NCT00107380|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2846582|NCT00107380|Primary|Response Rate (Complete, Complete Unconfirmed, and Partial)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|6 months|All eligible patients who started treatment were included in the analysis|||participants|||Number
2846583|NCT00107380|Primary|Progression-free Survival (PFS) at 2 Years|Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2846584|NCT00107315|Secondary|Toxicity|"Number of participants with an adverse event.~Please refer to the adverse event reporting for more detail."|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2846585|NCT00107315|Secondary|Median Survival||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2846586|NCT00107315|Secondary|Response Rate|Overall Response (OR) = CR + PR.|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2846587|NCT00107315|Primary|Time to Progression||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2846588|NCT00107276|Secondary|Toxicity|Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)|Eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)|||Participants|||Number
2846589|NCT00107276|Secondary|Progression-free Survival and Overall Survival|"Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.~Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.~Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression."|two years|All eligible patients|||months||95% Confidence Interval|Median
2846590|NCT00107276|Primary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|Eligible patients with RECIST measurable disease|||participants|||Number
2846591|NCT00107198|Secondary|Grade 3 or 4 Toxicity||Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.|Eligible patients beginning AV-PC.|||Participants|||Number
2846592|NCT00107198|Secondary|Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients|To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded. 136 patients received upfront AV-PC with or without RT per protocol. Of these 135 achieved CR with AV-PC and avoided RT. The median follow up among the 121 censored patients is 62.2 months (range 3.4-104.5).|||Probability participants||95% Confidence Interval|Number
2846593|NCT00107198|Secondary|Cure by Surgery Alone in Stage I Resected Patients|To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.|At 2 years|Of 188 patients enrolled, five ineligible patients were excluded. 52 patients with Stage IA, single node LPHL were enrolled with a confirmed total resection (TR). The median follow up among the 39 censored patients is 56.3 months (range 3.9-107.4).|||Probability participants||95% Confidence Interval|Number
2846594|NCT00107198|Secondary|Event-free Survival|Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded from this analysis. 183 patients are included. The median follow-up time for the 155 censored patients is 61.2 months (range 0.03-107.4).|||Probability participants||95% Confidence Interval|Number
2846595|NCT00107198|Primary|Failure-free Survival (FFS)|The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.|At 5 years|Of 188 patients enrolled, five ineligible patients and five patients who did not receive the upfront chemotherapy +/- RT per protocol were excluded from this analysis. 178 patients are included. The median follow-up for the 164 censored patients is 61.2 (range 3.5-107.4) months.|||Probability participants||95% Confidence Interval|Number
2846596|NCT00107172|Secondary|DLCO% Measured at Baseline and Month 3|"Pulmonary function tests included percentage predicted carbon~> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms."|3 months|All participants with complete pulmonary function test data at baseline and month 3.|||Percentage of Predicted||Full Range|Median
2846597|NCT00107172|Secondary|FEV1% Measured at Baseline and Month 3|Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms|3 months|All participants with complete pulmonary function test data at baseline and month 3.|||Percentage of Predicted||Full Range|Median
2846598|NCT00107172|Secondary|Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24|Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..|24 months|Participants who met the eligibility criteria and had SOBQ data at baseline, month 3, 12 or 24.|||units on a scale||Full Range|Median
2846599|NCT00107172|Secondary|Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24|Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.|24 months|Participants who met the eligibility criteria and had SF 36 data at baseline, month 3, 12 or 24.|||units on a scale||Full Range|Median
2846600|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection|The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.|90 days|All Intent-to-Treat (ITT) participants.|||participants|||Number
2846601|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection|Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|90 days|All Intent-to-Treat (ITT) participants.|||participants|||Number
2846602|NCT00107172|Secondary|Mortality Rates at 30- and 90-day After Sublobar Resection||90 days|All Intent-to-Treat (ITT) participants|||percentage of participants|||Number
2846603|NCT00107172|Secondary|Number of Participants Reported Distant Recurrence at 3 Years|Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant > metastatic disease (other organs).|3 years|All intent-to-treat participants.|||participants|||Number
2846607|NCT00107172|Primary|Time to Local Recurrence|Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.|Up to 3 years|All intent-to-treat (ITT) participants.|||years||95% Confidence Interval|Median
2846608|NCT00107120|Other Pre-specified|Children's Global Assessment Scale|Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).|At baseline and end of week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.|||Change in score||Standard Error|Mean
2846609|NCT00107120|Secondary|Clinical Global Impressions - Improvement|Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).|CGI-I score at the end of Week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.|||Score on scale||Standard Error|Mean
2846610|NCT00107120|Primary|Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score|Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.|Baseline to end of week 8|Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug & who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.|||Change in total score at endpoint||Standard Error|Mean
2846611|NCT00107042|Secondary|Assessment of Youth Understanding of Vaccine Trial and Informed Consent|Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.|Screening||||Number of correct answers||Standard Deviation|Mean
2846612|NCT00107042|Secondary|As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen|The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.|Week 28|Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.|||percentage of participants|||Number
2846613|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 28 and Week 76|Subjects in the Twinrix arm who had week 28 &/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered “Positive”. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was “Negative”.|||percentage of participants|||Number
2846614|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 76|Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.|||percentage of participants|||Number
2846615|NCT00107042|Secondary|Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.|Week 28|The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.|||percentage of participants|||Number
2846616|NCT00107042|Secondary|Immunogenicity to Hep B 18 Months After First Immunization|Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76|Week 76|"Participants who had a week 76 Hepatitis B antibody titer were included in this analysis.~One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer."|||Participants|||Number
2846617|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846645|NCT00106964|Primary|Sero-response to Hepatitis B Surface Antigen|The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|Participants who completed a Week 28 visit with a Hepatitis B serology result were included in this analysis.|||percentage of participants who resonded|||Number
2846618|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846619|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846620|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846621|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846622|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846623|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Age of participants' first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846624|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846633|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT|"Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a Responder if serum antibody level is >= 10 mIU/mL and a Non- Responder if a serum a'body level is < 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846625|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846626|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846627|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.|||Participants|||Number
2846628|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846629|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.|||Participants|||Number
2846630|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846631|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER|"Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum a'body level is < 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846632|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE|"Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846646|NCT00106938|Secondary|Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years||0 to 5 years||||percentage of participants|||Number
2846634|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.|"Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a Responder if serum a'body level is >= 10 mIU/mL and a Non- Responder if a serum antibody level is < 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses."|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.|||Participants|||Number
2846635|NCT00107042|Secondary|Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.|The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.|Week 28|The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).|||Participant|||Number
2846636|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)|"Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as Any vs. None. The number of participants with at least one SAE is reported."|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.|||participants|||Number
2846637|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))|"Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as Any vs. None. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported."|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.|||participants|||Number
2846638|NCT00107042|Secondary|Quantitative Vaccine Response|The Log10 titer was used as the quantitative vaccine response.|Week 28|Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.|||Log10 titer (mIU/ml)||Standard Deviation|Mean
2846639|NCT00107042|Primary|Qualitative Seroresponsiveness to Hepatitis B Surface Antigen|"Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows:~Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL."|Week (Wk) 28 (One month after the second immunization)|Participants were included if they were vaccinated at least once (Intent-to-Treat)|||Participants|||Number
2846640|NCT00106964|Secondary|Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM|Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|All participants who had a Week 28 Hepatitis B serology result|||percentage of participants who responded|||Number
2846641|NCT00106964|Secondary|Response Rates in HIV+ Youth Within Each Study Arm by Study Duration|Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.|Entry through Week 72|Population analyzed were those who had an antibody titer measured at Week 28.|||percentage of participants who responded|||Number
2846642|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY|The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.|Baseline through Week 72|All enrolled participants were included in this analysis. The following no. of participants experienced at least one Grade 2 or higher abnormal labs by study arm.|||Events|Events||Number
2846643|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED|The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of AEs that were definitely related to study drug. There were no AEs above Grade 2 considered to be definitely related to study drug.|||event|||Number
2846644|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED|The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of all AEs that were possibly or probably related to study drug. There were no AEs above Grade 3 considered to be possibly or probably related to study drug.|||Events|||Number
2846714|NCT00106639|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846647|NCT00106938|Secondary|Death or Major Stroke (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
2846648|NCT00106938|Secondary|Death or Stroke (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
2846649|NCT00106938|Secondary|Death, Stroke or Myocardial Infarction (MI) (Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
2846650|NCT00106938|Secondary|Myocardial Infarction (MI) (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
2846651|NCT00106938|Secondary|All Stroke (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
2846652|NCT00106938|Secondary|Death (Non-Hierarchical)||≤ 30 Days Post Index Procedure|Analysis population Includes only the most serious event for each subject and includes only each subject's first occurrence of the event. Subjects who did not complete 30 day follow-up and did not have any death, stroke or MI events are excluded.|||percentage of participants||95% Confidence Interval|Number
2846653|NCT00106938|Secondary|Freedom From All Stroke||0 to 1825 days||||percentage of participants|||Number
2846654|NCT00106938|Secondary|Freedom From All Stroke||0 to 1460 days||||percentage of participants|||Number
2846655|NCT00106938|Secondary|Freedom From All Stroke||0 to 1095 days||||percentage of participants|||Number
2846656|NCT00106938|Secondary|Freedom From All Stroke||0 to 730 days||||percentage of participants|||Number
2846657|NCT00106938|Secondary|Freedom From All Stroke||0 to 365 days||||percentage of participants|||Number
2846658|NCT00106938|Secondary|Freedom From Mortality||0 to 1825 days||||percentage of participants|||Number
2846659|NCT00106938|Secondary|Freedom From Mortality||0 to 1460 days||||percentage of participants|||Number
2846660|NCT00106938|Secondary|Freedom From Mortality||0 to 1095 days||||percentage of partcipants|||Number
2846661|NCT00106938|Secondary|Freedom From Mortality||0 to 730 days||||percentage of participants|||Number
2846662|NCT00106938|Secondary|Freedom From Mortality||0 to 365 days||||percentage of participants|||Number
2846663|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1825 days||||percentage of participants|||Number
2846664|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1460 days||||percentage of participants|||Number
2846665|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 1095 days||||percentage of participants|||Number
2846666|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 730 days||||percentage of participants|||Number
2846667|NCT00106938|Secondary|Freedom From Ipsilateral Stroke|Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.|31 to 365 days||||percentage of participants|||Number
2846668|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1825 days||||percentage of partcipants|||Number
2846669|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1460 days||||percentage of partcipants|||Number
2846670|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 1095 days||||percentage of partcipants|||Number
2846671|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 730 days||||percentage of partcipants|||Number
2846672|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization|Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 365 days||||percentage of partcipants|||Number
2846673|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)|Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.|0 to 180 days||||percentage of partcipants|||Number
2846674|NCT00106938|Secondary|Composite Morbidity Measure|A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.|0 to 30 Days Post-procedure|Intent-to-Treat (ITT) population|||participants|||Number
2846675|NCT00106938|Secondary|Procedural Success|Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.|0 to 30 days post procedure|The analysis population is Procedure success is per subject basis including the attempted CAS (carotid artery stenting) procedure only. CEA group is not part of analysis population for procedure success.|||percentage of participants|||Number
2846676|NCT00106938|Secondary|Acute Device Success: Embolic Protection Device System|Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.|On day 0 after index procedure|Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.|||Percentage of devices|Devices|95% Confidence Interval|Mean
2846677|NCT00106938|Secondary|Acute Device Success: Xact Carotid Stent|Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.|On day 0 after index procedure|Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.|||percentage of devices|devices|95% Confidence Interval|Number
2846678|NCT00106938|Primary|Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.||0 to 365 days||||percentage of participants|||Number
2846679|NCT00106704|Secondary|Change From Baseline in FPG at Week 24|The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data after rescue were considered missing.|||mg/dL||95% Confidence Interval|Least Squares Mean
2846680|NCT00106704|Primary|Change From Baseline in A1C at Week 24|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.|||Percent||95% Confidence Interval|Least Squares Mean
2846681|NCT00106639|Secondary|Number of Participants With Discontinuation||Month 1, 2, 3, 4, 5, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846682|NCT00106639|Secondary|Electrocardiogram (ECG) Parameters|ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.|Baseline, Month 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||millisecond||Standard Deviation|Mean
2846683|NCT00106639|Secondary|Alanine Aminotransferase (ALT) Level|ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||unit/liter||Standard Deviation|Mean
2846684|NCT00106639|Secondary|Hematocrit Level|The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||percentage of blood||Standard Deviation|Mean
2846685|NCT00106639|Secondary|Hemoglobin Level|Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||g/dL||Standard Deviation|Mean
2846686|NCT00106639|Secondary|Absolute Platelet Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.|||platelets*10^3/mm^3||Standard Deviation|Mean
2846687|NCT00106639|Secondary|Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.|||cells*10^3/mm^3||Standard Deviation|Mean
2846688|NCT00106639|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication and based on time due to lost of follow-up, or up to Month 6. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||participants|||Number
2846689|NCT00106639|Secondary|BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||Copies/20 mcL plasma||Standard Deviation|Mean
2846690|NCT00106639|Secondary|Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||Copies/500 ng DNA||Standard Deviation|Mean
2846691|NCT00106639|Secondary|Number of Participants With Drug Usage|Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||participants|||Number
2846692|NCT00106639|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)||Baseline, Day 2, 3, 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||millimeter of mercury||Standard Deviation|Mean
2846693|NCT00106639|Secondary|Number of Participants With Hypertriglyceridemia|Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.|||participants|||Number
2846694|NCT00106639|Secondary|Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||mg/dL||Standard Deviation|Mean
2846695|NCT00106639|Secondary|Number of Participants With Hypercholesterolemia|Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||participants|||Number
2846696|NCT00106639|Secondary|Fasting Serum Glucose Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||mg/dL||Standard Deviation|Mean
2846697|NCT00106639|Secondary|Number of Participants With New Onset Diabetes Mellitus (NODM)||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846698|NCT00106639|Secondary|Number of Participants With First Clinically Significant Infection|Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846699|NCT00106639|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Month 8 (2 months follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846700|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)|GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points.|||deciliter/mg (dL/mg)||Standard Deviation|Mean
2846701|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 * (serum creatinine) ^ (-0.999)*(age in years)^(-0.176)*(0.762 if female) * (1.18 if black)*(blood urea nitrogen concentration)^(-0.170)*(serum albumin concentration)^(0.318). Normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.|||mL/min/1.73 m^2||Standard Deviation|Mean
2846715|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846975|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846702|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Cockcroft-Gault|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||mL/min||Standard Deviation|Mean
2846703|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question|"Fifth question in the HCRUQ was Upon discharge from the hospital, did you return to your previous place of residence? and number of participants who responded yes or no to the question was reported."|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2846704|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ)|Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||events||Standard Deviation|Mean
2846705|NCT00106639|Secondary|End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)|"ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated questionAt the moment,how much do you suffer?for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction."|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||units on a scale||Standard Deviation|Mean
2846706|NCT00106639|Secondary|36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||units on a scale||Standard Deviation|Mean
2846707|NCT00106639|Secondary|Trough Levels of Tacrolimus (TAC)||Pre-dose on Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2846708|NCT00106639|Secondary|Reticulocyte Count|Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells*10^3 per cubic millimeter (cells*10^3/mm^3).|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||cells*10^3/mm^3||Standard Deviation|Mean
2846709|NCT00106639|Secondary|Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets|The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
2846710|NCT00106639|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6|||||||
2846711|NCT00106639|Secondary|Number of Participants With Rejection|Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846712|NCT00106639|Secondary|Number of Participants Who Died||Month 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846713|NCT00106639|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846716|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)|Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846717|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846718|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 3|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846719|NCT00106639|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the first occurrence of BPAR, graft loss, participant's death or premature discontinuation of study medication for any reason.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846720|NCT00106639|Primary|Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is >90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies those participants evaluable for this measure.|||mL/min||Standard Deviation|Mean
2846721|NCT00106639|Primary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 6|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
2846722|NCT00106626|Secondary|Safety and Tolerability as Measured by the Number of Participants With Disease Progression|Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator.|Any time during 8 cycle treatment period through 30 days after.|All participants. Treated Population includes all participants who received at least one dose and had efficacy measurements at baseline and at least one post baseline treatment.|||Participants|||Number
2846723|NCT00106626|Primary|Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level|MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.|Cycle 1 (21 days)|A total of 52 participants were enrolled in this study. Six were violations pts (1 in Cohort C Dose Level 1, 1 in Cohort C Dose Level 2, 3 in Cohort D Dose Level 1, and 1 in Cohort D Dose Level 2) and were replaced. None of the violations pts had any DLTs in the first cycle of the study.|||Participants|||Number
2846724|NCT00106535|Secondary|End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation.|||Score on a scale||Standard Deviation|Mean
2846725|NCT00106535|Secondary|End of Study: Change From Baseline in Erosion Score at Week 260|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.|||Score on a scale||Standard Deviation|Mean
2846726|NCT00106535|Secondary|End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260|Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.|||Score on a scale||Standard Deviation|Mean
2848006|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||g/L||Standard Deviation|Mean
2846727|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.|||Percentage of participants|||Number
2846728|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.|||Percentage of participants|||Number
2846729|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Pain VAS at Week 260|"The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.|||mm||Standard Deviation|Mean
2846730|NCT00106535|Secondary|End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.|||mm||Standard Deviation|Mean
2846731|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.|||mm||Standard Deviation|Mean
2846732|NCT00106535|Secondary|End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. No imputation was used for missing HAQ score.|||Score on a scale||Standard Deviation|Mean
2846733|NCT00106535|Secondary|End of Study: Change From Baseline in Tender Joint Count at Week 260|68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.|||Joint Count||Standard Deviation|Mean
2846734|NCT00106535|Secondary|End of Study: Change From Baseline in Swollen Joint Count at Week 260|66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.|||Joint Count||Standard Deviation|Mean
2846735|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.|||Percentage of participants|||Number
2849216|NCT00089102|Secondary|Duration of Response||From registration until disease progression among patients who had at least a partial response|Data is not available for this endpoint was not collected.||||||
2846736|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 ≤3.2.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.|||Percentage of participants|||Number
2846737|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Remission at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.|||Percentage of participants|||Number
2846738|NCT00106535|Secondary|End of Study: Percentage of Participants With ACR Response at Week 260|ACR20/50/70/90 response is defined as a ≥ 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Baseline and Week 260. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments.|||Percentage of participants|||Number
2846739|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 104|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score].|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846740|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 52|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.|52 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to ’Non Responder’.|||Percentage of participants|||Number
2846741|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104|The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.|||Percentage of participants|||Number
2846742|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52|The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|52 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.|||Percentage of participants|||Number
2846835|NCT00106431|Primary|The Percent of Patients (Pts) With Objective Disease Response|The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).|6 months|Efficacy analysis based on interim analysis of data for as treated population|||Percent of participants|||Number
2846743|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24|The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|24 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to ’Non Responder’.|||Percentage of participants|||Number
2846744|NCT00106535|Secondary|Percentage of Participants in Each Treatment Group Who Receive Escape Therapy|"In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.~In Escape 2, all participants received tocilizumab 8 mg/kg."|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis.|||Percentage of participants|||Number
2846745|NCT00106535|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. Data on escape therapy is excluded.|||Percentage of participants|||Number
2846746|NCT00106535|Secondary|Time to Onset of ACR70 by Treatment Group|Time in days until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR70 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.|||Days||95% Confidence Interval|Median
2846747|NCT00106535|Secondary|Time to Onset of ACR50 by Treatment Group|Time in days until ACR50 response. ACR50 response was defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR50 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.|||Days||95% Confidence Interval|Median
2846748|NCT00106535|Secondary|Time to Onset of ACR20 by Treatment Group|Time in days until ACR20 response. ACR20 response was defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR20 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.|||Days||95% Confidence Interval|Median
2846749|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||IU/mL||Standard Deviation|Mean
2846750|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||IU/mL||Standard Deviation|Mean
2846751|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||IU/mL||Standard Deviation|Mean
2846752|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 104|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846753|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846754|NCT00106535|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing FACIT-Fatigue scores. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846755|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 104|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846756|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 52|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846757|NCT00106535|Secondary|Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. . Data was set to missing for patients who received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846758|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index at Week 104|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846759|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846760|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
2846761|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
2846762|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
2846763|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.|||Percentage of participants|||Number
2846764|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Percentage of participants|||Number
2846765|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy was excluded.|||Percentage of participants|||Number
2846766|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Score on a scale||Standard Deviation|Mean
2846930|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2849217|NCT00089102|Primary|Response Proportion||From registration until time of complete response or partial response|All patients treated on study who underwent a response assessment|||Participants|||Count of Participants
2846767|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 80|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Score on a scale||Standard Deviation|Mean
2846768|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.|||Score on a scale||Standard Deviation|Mean
2846769|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846770|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
2846771|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 80|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
2846772|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data for this outcome measure. Missing Week 52 data was imputed using Linear extrapolation. Data was set to missing for patients who withdrew or received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846773|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846774|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 80|Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
2846858|NCT00106353|Primary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846775|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 24|Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
2846776|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
2846777|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|52 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
2846778|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
2846779|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
2846780|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score <2.6.|Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
2846781|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
2846971|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846782|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 104|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation was used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.|||Percentage of participants|||Number
2846783|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 52|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.|||Percentage of participants|||Number
2846784|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 24|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.|||Percentage of participants|||Number
2846785|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846786|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846787|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846788|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn Score at Week 104|The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
2848007|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||g/L||Standard Deviation|Mean
2846789|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 52|The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|52 Weeks|Participants from the Intent-to-treat population(all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Full Range|Least Squares Mean
2846790|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 24|The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale*week||Standard Deviation|Mean
2846791|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104|"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).~."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||Percentage of participants|||Number
2846792|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing for patients who received escape therapy.|||Percentage of participants|||Number
2846793|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||mm/hr||Standard Deviation|Mean
2846794|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 104|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.|||mg/dL||Standard Deviation|Mean
2846795|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 104|"The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846796|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104|"The physician's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846859|NCT00106353|Primary|Number of Participants Who Died: Part 1|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846797|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy|||Score on a scale||Standard Deviation|Mean
2846798|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 104|68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
2846799|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 104|66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
2846800|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.|||mm/hr||Standard Deviation|Mean
2846801|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was made for missing data. All assessments were set to missing from the time a patient received escape therapy.|||mg/dL||Standard Deviation|Mean
2846802|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 52|"The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. Data was set to missing for patients who received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846803|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing after the patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846804|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52|"The patient's global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||Score on a scale||Standard Deviation|Mean
2846805|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 52|68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for missing tender joint data. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
2846806|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 52|66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||Joint count||Standard Deviation|Mean
2846807|NCT00106535|Secondary|Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846808|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 104|ACR50 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846809|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 52|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846810|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 104|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846811|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 52|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846880|NCT00106249|Secondary|Motor Cortex Excitability (Short Intracortical Inhibition)|In 22 OCD patients enrolled in the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. For the paired-pulse (PP) measurements of short intracortical inhibition (SICI) the interstimulus interval (ISI) was set to 8-12 seconds on a continuous uniform distribution. The FPGA board samples the EMG data, controls the timing of the TMS stimuli, and also controls the intensity of the devices.|Through study completion|Independent sample t-test, right hemisphere SICI|||% change in conditioned/control MEP||Full Range|Mean
2846812|NCT00106535|Secondary|Percentage of Participants With ACR20 Response at Week 104|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846813|NCT00106535|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846814|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.|Baseline to Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. For patients who received escape therapy, the HAQ-DI was set to missing from the time they entered escape.|||Score on a scale*week||Full Range|Least Squares Mean
2846815|NCT00106535|Primary|Change From Baseline in the Modified Total Sharp-Genant Score at Week 104|Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or for patients on escape therapy the data is excluded. Missing data was imputed using linear extrapolation.|||Score on a scale||Standard Deviation|Mean
2846816|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.|Baseline to Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. All assessments were set to missing after a patient received escape therapy.|||Score on a scale*week||Full Range|Least Squares Mean
2846919|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population|Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data|||Participants|||Number
2846817|NCT00106535|Primary|Change From Baseline in Modified Total Sharp-Genant Score at Week 52|Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat (ITT) population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing week 52 data. Data collected after withdrawal or on escape therapy is excluded.|||Score on a scale||Standard Deviation|Mean
2846818|NCT00106535|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24|HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing HAQ-DI. All assessments were set to missing from the time a patient received escape therapy.|||Scores on a scale||Standard Deviation|Mean
2846819|NCT00106535|Secondary|Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24|The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing ESR. All assessments were set to missing from the time a patient received escape therapy.|||millimeters/hour (mm/hr)||Standard Deviation|Mean
2846820|NCT00106535|Secondary|C-Reactive Protein (CRP): Mean Change From Baseline at Week 24|The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing CRP. All assessments were set to missing from the time a patient received escape therapy.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
2846821|NCT00106535|Secondary|Patient's Pain VAS: Mean Change From Baseline at Week 24|"The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change indicated improvement."|Baseline and Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||mm||Standard Deviation|Mean
2846822|NCT00106535|Secondary|Physician's Global VAS: Mean Change From Baseline at Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity)."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||mm||Standard Deviation|Mean
2846823|NCT00106535|Secondary|Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24|"The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.|||millimeters (mm)||Standard Deviation|Mean
2846824|NCT00106535|Secondary|Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||joint count||Standard Deviation|Mean
2846825|NCT00106535|Secondary|Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.|||joint count||Standard Deviation|Mean
2846972|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
2846826|NCT00106535|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline,Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846827|NCT00106535|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846828|NCT00106535|Primary|Percentage of Participants With American College of Rheumatology-ACR20 Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 24|Intent-to-treat (ITT) population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.|||Percentage of participants|||Number
2846829|NCT00106431|Secondary|Percent of Pts With Objective Disease Control|The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population|||Percent of participants|||Number
2846830|NCT00106431|Secondary|Duration of Objective Disease Control (ODC)|For pts with confirmed ODC (pts with CR, CCR, PR, SD90 [stable disease for 90 days]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data.|Up to 10 months; median duration of follow up was 6.0 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
2846831|NCT00106431|Secondary|Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.|Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.|Up to 10 months|Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of >=30 mm)|||participants|||Number
2846832|NCT00106431|Secondary|Time to Disease Progression|Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 6.1 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
2846833|NCT00106431|Secondary|Time to Objective Disease Response|Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed).|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
2846834|NCT00106431|Secondary|Duration of Objective Disease Response|Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response [CCR], or partial response [PR]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 5.1 months|Efficacy analysis based on interim analysis of data for as treated population|||Months||Full Range|Median
2849709|NCT00084084|Primary|Patients Who Experienced At Least One Adverse Event (AE)||362 weeks|Safety Population: Patients in Cohort 1 who received at least one dose of Replagal RB in Phase 1.|||participants|||Number
2846836|NCT00106392|Secondary|Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire|Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation."|||Overall Score of Urinary Function||Full Range|Median
2846837|NCT00106392|Secondary|Time to Achieve Response to Impotence Medications|Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who had a successful response to impotence medications were included in the calculations."|||Days||Full Range|Median
2846838|NCT00106392|Secondary|Percentage of Patients Considered Successful Responders to Impotence Medications|Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who used any impotence medications were included in the calculation."|||Percentage of Participants|||Number
2846839|NCT00106392|Secondary|Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who achieved normal erectile function are included in the calculation."|||Days||Full Range|Median
2846840|NCT00106392|Secondary|Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score|"Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.~Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months."|24 months|The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.|||Percentage of Participants|||Number
2846841|NCT00106392|Primary|Erectile Function Domain Score Between Treated and Untreated Groups|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.|18 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants with complete IIEF questionnaire data at 18 months are included in the calculation."|||Erectile Function Domain Score||Full Range|Median
2846842|NCT00106353|Secondary|Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2|Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.|Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)|Data was not analyzed.||||||
2846843|NCT00106353|Secondary|Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2|Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).|Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Data was not analyzed.||||||
2846844|NCT00106353|Secondary|Clearance (CL): Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||L/hr||Standard Deviation|Mean
2846845|NCT00106353|Secondary|Area Under the Concentration-time Curve at Steady State (AUCss): Part 2|AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr*ng/mL||Standard Deviation|Mean
2846920|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 36|ITT Population|||Participants|||Number
2846846|NCT00106353|Primary|Percentage of Participants With Objective Response (OR) at Week 12: Part 2|Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.|||percentage of participants|||Number
2846847|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846848|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr*ng/mL||Standard Deviation|Mean
2846849|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for.|||hr||Standard Deviation|Mean
2846850|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2||0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr||Full Range|Median
2846851|NCT00106353|Secondary|Average Plasma Concentration (Cavg): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2846852|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2846853|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846854|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846855|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846856|NCT00106353|Primary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1|Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846857|NCT00106353|Primary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1|Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846860|NCT00106353|Primary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846861|NCT00106353|Primary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846862|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2|Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846863|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846864|NCT00106353|Secondary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846865|NCT00106353|Secondary|Number of Participants Who Died: Part 2|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846866|NCT00106353|Secondary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846867|NCT00106353|Secondary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846868|NCT00106353|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846869|NCT00106353|Secondary|Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2|Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.|||percentage of participants||95% Confidence Interval|Number
2846921|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 12|ITT Population|||Participants|||Number
2848008|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 3|Laboratory hematology hemoglobin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||g/L||Standard Deviation|Mean
2846870|NCT00106353|Secondary|Percentage of Participants With Best Overall Response: Part 1|Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.|Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)|Efficacy evaluable population included all participants who received at least 3 doses of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.|||percentage of participants|||Number
2846871|NCT00106353|Secondary|Volume of Distribution at Steady State (Vss): Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||Liter||Standard Deviation|Mean
2846872|NCT00106353|Secondary|Clearance (CL): Part 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||Liter/hr||Standard Deviation|Mean
2846873|NCT00106353|Secondary|Area Under the Concentration-Time Curve (AUC): Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr*ng/mL||Standard Deviation|Mean
2846874|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr*ng/mL||Standard Deviation|Mean
2846875|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr||Standard Deviation|Mean
2846876|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||hr||Standard Deviation|Mean
2846877|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2846878|NCT00106353|Secondary|Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1|Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.|Baseline up to Month 6|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2846879|NCT00106353|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to End of Treatment (EOT) (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2848009|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||g/L||Standard Deviation|Mean
2846881|NCT00106249|Secondary|Motor Cortex Excitability (Motor Threshold)|In 22 OCD patients, who completed the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. Specifically, the software delivers TMS pulses and automatically determines motor threshold (MT); a descending staircase method is utilized, starting at the intensity at which the optimal site selection for the MT is determined. After each stimulus in the MT experiments, the software would prompt the user to confirm the automated MEP-detection.|Through study completion|repeated measure ANOVA, time X group interaction, right hemisphere MT|||% MT change on right hemisphere||Full Range|Mean
2846882|NCT00106249|Primary|Clinical Improvement (Yale-Brown Obsessive Compulsive Scale/Y-BOCS)|Response rate was defined as a decrease >25% on the YBOCS-SR. Y-BOCS-Self Report (Baer et al. 1993) is very similar to the clinician-administered one, and has shown excellent internal consistency and test-retest reliability, performing somewhat better than the interview (Steketee et al., 1996); subjects are asked to focus on the main obsessions and main compulsions and to answer five questions: time spent, interference, distress, resistance, and control. Consistent with the interview format, subjects rate each item on a 0 (none) to 4 (extreme) scale.|Through study completion||||percentage of participants|||Number
2846883|NCT00106184|Secondary|20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI])|Number of participants with a 20% improvement in MMT over baseline on two consecutive time points.|Week 44 of treatment phase|Intention to Treat (ITT)|||Participants|||Number
2846884|NCT00106184|Secondary|Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.~Core Set Measures Included:~Manual Muscle Testing (MMT)- Muscle Strength~Physician Global Disease Activity VAS Score~Health Assessment Questionnaire Index Score - Physical Function~Patient Global Assessment of Disease Activity VAS score~Extramuscular Activity - Myositis Disease Activity Assessment Tool~2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 8 of the treatment phase|Intention to Treat (ITT)|||participants|||Number
2846885|NCT00106184|Primary|Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.~Core Set Measures Included:~Manual Muscle Testing (MMT)- Muscle Strength~Physician Global Disease Activity VAS Score~Health Assessment Questionnaire Index Score - Physical Function~Patient Global Assessment of Disease Activity VAS score~Extramuscular Activity - Myositis Disease Activity Assessment Tool~2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 44 of treatment phase|Intention to Treat (ITT)|||Weeks||Full Range|Median
2846886|NCT00106119|Secondary|Apolipoprotein B at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846887|NCT00106119|Secondary|Apolipoprotein B at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846888|NCT00106119|Secondary|Apolipoprotein A-I at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846889|NCT00106119|Secondary|Apolipoprotein A-I at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846890|NCT00106119|Secondary|Left Ventricle Mass Index at Liothyronine Treatment Phase||One month of therapy.||||g/m^2||Standard Deviation|Mean
2846891|NCT00106119|Secondary|Left Ventricle Mass Index at Levothyroxine Treatment Phase||One month of therapy.||||g/m^2||Standard Deviation|Mean
2846892|NCT00106119|Secondary|Resting Energy Expenditure at Liothyronine Treatment Phase||One month of therapy.||||kcal/24 hour||Standard Deviation|Mean
2846893|NCT00106119|Secondary|Resting Energy Expenditure at Levothyroxine Treatment Phase||One month of therapy.||||kcal/24 hour||Standard Deviation|Mean
2846894|NCT00106119|Secondary|Triglycerides at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846895|NCT00106119|Secondary|Triglycerides at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846896|NCT00106119|Secondary|Total Cholesterol at Liothyronine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846897|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase||One month of therapy||||mg/kg/min||Standard Deviation|Mean
2846898|NCT00106119|Secondary|Total Cholesterol at Levothyroxine Treatment Phase||One month of therapy.||||mg/dl||Standard Deviation|Mean
2846899|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase||One month of therapy.||||mg/kg/min||Standard Deviation|Mean
2846900|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 25||||Ratio of glutamate to creatine||Standard Error|Mean
2846922|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 36, ITT Population|Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 36|ITT Population|||Participants|||Number
2846973|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
2846901|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 4|The analysis of participants was per protocol, i.e., all subjects who completed two MRS scans(Day 4 and Day 25) and for whom there were two measures of the glutamate/creatine ratio|||Ratio of glutamate to creatine||Standard Error|Mean
2846902|NCT00106080|Secondary|Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.|We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.|Assessed 2 weeks after targeted clinic visit||||Proportion of participants reporting||95% Confidence Interval|Number
2846903|NCT00106080|Primary|Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale|The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.|Measured at enrollment and 2 weeks after targeted clinic visit||||units on a scale||95% Confidence Interval|Mean
2846904|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 36|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data|||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
2846905|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data|||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
2846906|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 36, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 36|ITT Population|||Years||95% Confidence Interval|Least Squares Mean
2846907|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 24, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 24|ITT Population|||Years||95% Confidence Interval|Least Squares Mean
2846908|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 12, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 12|ITT Population|||Years||95% Confidence Interval|Least Squares Mean
2846909|NCT00106028|Secondary|Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population|Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.|Baseline and Month 12|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2846910|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846911|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846912|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Endpoint / Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846913|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 36, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 36 Months|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846914|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 24, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 24 Months|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846915|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 12, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 12 Months|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846916|NCT00106028|Secondary|Number of Clinical Fractures, Month 12, ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|12 Months|ITT Population|||Participants|||Number
2846917|NCT00106028|Secondary|Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|Time to First Event (days) up to 12 Months|ITT Population|||Probability of Fractures|||Number
2846918|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population|Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data|||Participants|||Number
2846923|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 12, ITT Population|Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 12|ITT Population|||Participants|||Number
2846931|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2846932|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2846933|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2846934|NCT00106028|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.|Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846935|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2846936|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population|||Units on a Scale||95% Confidence Interval|Least Squares Mean
2846937|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 36, ITT Population||Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846938|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 24, ITT Population||Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846939|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 12, ITT Population||Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846940|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population||Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846941|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population||Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846942|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population||Baseline and Month 12|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846943|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 36, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 36|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2846944|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 24, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 24|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2846945|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 12, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 12|ITT Population.|||Percent Change||95% Confidence Interval|Least Squares Mean
2846946|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 36|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846947|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 24|ITT Population|||Percent Change||95% Confidence Interval|Least Squares Mean
2846948|NCT00106002|Secondary|Overall Survival Time|Defined as the time from date of first dose to time of death due to any cause.|every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up|Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)|||months||Full Range|Median
2846949|NCT00106002|Secondary|Progression-Free Survival Time|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)|||months||Full Range|Median
2846950|NCT00106002|Secondary|Duration of Tumor Response|Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Only applies to patients who had a complete or partial response|||months||Full Range|Median
2846951|NCT00106002|Secondary|Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)|Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).|every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up||||participants|||Number
2846952|NCT00106002|Primary|Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression||||participants|||Number
2846953|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase||Every Visit from Week 10 up to Week 34 (Continuation)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.|||participants|||Number
2846954|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase||Every Visit from Week 0 up to Week 10 (Acute)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.|||participants|||Number
2846955|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846956|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846957|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Units per Liter||Standard Deviation|Mean
2846958|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
2846959|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
2846960|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||femtoliters||Standard Deviation|Mean
2846961|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846962|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846963|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
2846964|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846965|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Actual count||Standard Deviation|Mean
2846966|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Units per Liter||Standard Deviation|Mean
2846967|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Tera per Liter||Standard Deviation|Mean
2846968|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846969|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
2846970|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||micromoles per Liter||Standard Deviation|Mean
2846974|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
2846976|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
2846977|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846978|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||actual count||Standard Deviation|Mean
2846979|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Units per Liter||Standard Deviation|Mean
2846980|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||Giga per Liter||Standard Deviation|Mean
2846981|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846982|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||millimoles per Liter||Standard Deviation|Mean
2846983|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||grams per Liter||Standard Deviation|Mean
2846984|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||mm Hg||Standard Error|Least Squares Mean
2846985|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||mm Hg||Standard Deviation|Mean
2846986|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||beats per minute||Standard Error|Least Squares Mean
2846987|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||beats per minute||Standard Deviation|Mean
2846988|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||kilograms||Standard Error|Least Squares Mean
2846989|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||kilograms||Standard Deviation|Mean
2846990|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2846991|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2846992|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2851700|NCT00053989|Secondary|OS|Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion|1 year||||percentage of participants||95% Confidence Interval|Number
2846993|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2846994|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis.|||hours||Standard Error|Least Squares Mean
2846995|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis.|||hours||Standard Deviation|Mean
2846996|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay. Intent to Treat analysis.|||hours||Standard Error|Least Squares Mean
2846997|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis.|||hours||Standard Deviation|Mean
2846998|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 through Week 86 (Maintenance Phase)|Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis.|||visits||Standard Error|Least Squares Mean
2846999|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 through Week10 (Acute) through Week 34 (Continuation)|"Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: Other Mental Health Care Worker wasn't included in table (1 patient in Acute). Other Health Care Worker wasn’t included in table (2 patients in Continuation)."|||visits||Standard Deviation|Mean
2847000|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847001|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847002|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2848014|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847003|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847004|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847005|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847006|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847007|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847008|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847009|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847010|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 86 (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847011|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847012|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847026|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group|7 years||||percentage of participants||95% Confidence Interval|Number
2847013|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847014|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Error|Least Squares Mean
2847015|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.|||units on a scale||Standard Deviation|Mean
2847016|NCT00105989|Secondary|Loss of Response at Any Time|Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.|||participants|||Number
2847017|NCT00105989|Secondary|Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days|Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis.|||percentage of participants|||Number
2847018|NCT00105989|Secondary|Recurrence Count|Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.|||participants|||Number
2847019|NCT00105989|Primary|Percentage of Participants With Depressive Recurrence After Time (t) in Days|Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|All randomized patients. Intent to Treat analysis.|||percentage of participants|||Number
2847020|NCT00105586|Secondary|Quality of Life|Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment).|Measured at Week 12|Quality of Life scales were collected on all participants randomized to Escitalopram and placebo|||units on a scale||Standard Deviation|Mean
2847021|NCT00105586|Primary|Response Using Clinical Global Impressions-Improvement Scale (CGI-I)|Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA).|Measured at Weeks 1-12||||participants|||Number
2847022|NCT00105560|Secondary|Overall Survival|the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group.|5 years, 7 years, 10 years|Follow-up for the 10 year follow-up is still ongoing and the data is not yet available.|||percentage of participants surviving||95% Confidence Interval|Number
2847023|NCT00105560|Secondary|Progression Free Survival|The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group.|5 years, 7 years, 10 years|Follow-up is ongoing and data is not yet available for the 10 year follow-up time point.|||percentage of participants surviving||95% Confidence Interval|Number
2847024|NCT00105560|Secondary|Mean Change Per-Year in Neurocognitive Outcomes|The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first).|Baseline, 1, 3, 5, 7 years|The study participants that were evaluated for changes in neurocognitive outcomes|||units on a scale||95% Confidence Interval|Mean
2847025|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 10 Years|percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) by the end of study follow-up (as determined by CTCAE 3.0) by hormone type and risk group.|End of follow-up||2021-12-31|12/2021||||
2847027|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group.|5 years||||percentage of participants||95% Confidence Interval|Number
2847028|NCT00105560|Secondary|Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years|Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group|3 years||||percentage of participants||95% Confidence Interval|Number
2847029|NCT00105560|Primary|Cumulative Incidence of Ototoxicity|Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.|3 Years, 5 years, 7 years, 10 years|The overall study population after the stated durations of follow-up. Follow-up is ongoing and data is not yet available for the 10 year time point.|||percentage of participants||95% Confidence Interval|Number
2847030|NCT00105534|Secondary|Participants Who Achieved Bacteriological Eradication|Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.|||Participants|||Number
2847031|NCT00105534|Primary|Participants Who Achieved Clinical Resolution|Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.|Visit 3 (Days 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.|||Participants|||Number
2847032|NCT00105521|Secondary|Change From Baseline in UPDRS Part III Total Score at Week 12|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported.|Baseline, Week 12|modified ITT population.|||units on a scale||Standard Deviation|Mean
2847033|NCT00105521|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.|Baseline, Week 12|Modified ITT population.|||units on a scale||Standard Deviation|Mean
2847034|NCT00105521|Secondary|Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12|Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported.|Baseline, Week 12|Modified ITT population.|||units on a scale||Standard Deviation|Mean
2847035|NCT00105521|Primary|Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12|On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.|Baseline, Week 12|Modified intent-to-treat (ITT) population included all randomized participants who received at least one treatment dose and who had at least one follow-up visit assessment for an efficacy target outcome.|||hours/day||Standard Deviation|Mean
2847036|NCT00105508|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline.|Baseline, Week 24|"Intent to treat population included all subjects who were randomized in the study. Here Overall Number of Participants Analyzed signifies those subjects who were evaluated for this outcome measure."|||units on a scale||Standard Deviation|Mean
2847037|NCT00105508|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12|The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline.|Baseline, Week 12|"Intent to treat population included all subjects who were randomized in the study. Here Overall Number of Participants Analyzed signifies those subjects who were evaluated for this outcome measure."|||units on a scale||Standard Deviation|Mean
2847061|NCT00105235|Primary|Proportion of Participants Who Have Graft Loss or Death|Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure.|Within 1 year of post-transplantation|Safety Sample|||Proportion of Participants|||Number
2847038|NCT00105508|Primary|Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24|Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.|Week 24|Intent to treat population included all subjects who were randomized in the study.|||percentage of subjects|||Number
2847039|NCT00105508|Primary|Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12|Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.|Week 12|Intent to treat population included all subjects who were randomized in the study.|||percentage of subjects|||Number
2847040|NCT00105482|Secondary|Cigarettes Smoked Per Day.|Average number of cigarettes smoked per day at 26 weeks.|26 weeks|Patients were analyzed per protocol.|||number of cigarettes||Standard Deviation|Mean
2847041|NCT00105482|Secondary|Point Prevalence Smoking Abstinence at 6 Weeks|The number of people that were abstinent from cigarette smoking at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.|||participants|||Number
2847042|NCT00105482|Secondary|Weight Gain at 6 Weeks.|Weight change from baseline measured at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.|||pounds||Standard Deviation|Mean
2847043|NCT00105482|Primary|Point Prevalence Smoking Abstinence at 26 Weeks.|The number of people that were abstinent from cigarette smoking at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.|||participants|||Number
2847044|NCT00105482|Primary|Weight Gain at 26 Weeks.|Weight change from baseline measured at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.|||pounds||Standard Deviation|Mean
2847045|NCT00105469|Secondary|Number of Participants Who Achieved Bacterial Eradication at Visit 3|Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."|||Participants|||Number
2847046|NCT00105469|Primary|Number of Participants Who Achieved Clinical Resolution at Visit 3|Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."|||Participants|||Number
2847047|NCT00105443|Post-Hoc|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline <8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.|||Participants|||Number
2847048|NCT00105443|Post-Hoc|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of CR, PR, or SD that is maintained at least 28 days from the first manifestation of that rating.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|The disease control rate for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors (RECIST) up to the cutoff date of 09 Feb 2007|||Participants|||Number
2847049|NCT00105443|Post-Hoc|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment|The independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments|||Days||95% Confidence Interval|Median
2847050|NCT00105443|Post-Hoc|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression|from randomization to the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment|For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.|||Days||95% Confidence Interval|Median
2847051|NCT00105443|Post-Hoc|Overall Survival|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment|The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment|||Days||95% Confidence Interval|Median
2847052|NCT00105443|Secondary|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.|from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline <8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006|||Participants|||Number
2847053|NCT00105443|Secondary|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors [RECIST])|||Participants|||Number
2847054|NCT00105443|Secondary|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment|The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006|||days||95% Confidence Interval|Median
2847055|NCT00105443|Primary|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression.|from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment|This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.|||days||95% Confidence Interval|Median
2847056|NCT00105443|Primary|Overall Survival (OS)|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.|||days||95% Confidence Interval|Median
2847057|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee, were successfully withdrawn from immunosuppressants, and remained off immunosuppressants at the time the trial ended. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks and do not restart immunosuppressant drugs after successful withdrawal.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat|||Proportion of Participants|||Number
2847058|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn From Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat|||Proportion of Participants|||Number
2847059|NCT00105235|Secondary|Number of Events: Immunosuppression-related Complications|Certain events are associated with immunosuppression. This measure looks at post-transplant infection, post-transplant malignancies, post-transplant diabetes, and post-transplant renal failure. Immunosuppression withdrawal is intended to reduce these type of events. However, reduction in immunosuppression can lead to complications in liver and renal function, as measured by acute rejection, chronic rejection, and post-transplant renal failure. Lower numbers for any of these events indicates greater success with transplantation and immunosuppression withdrawal (where applicable)|From transplantation until study completion or participant termination (participants followed up to 60 months)|Safety Sample|||Events|||Number
2847060|NCT00105235|Secondary|Proportion of Participants Who Had Graft Loss or Death|Proportion of participants who had liver graft loss or who died or terminated from the study within 2 years of initiating immunosuppression withdrawal|Within 2 years after initiation of immunosuppression withdrawal|Participants who initiated immunosuppression withdrawal|||Proportion of Participants|||Number
2847062|NCT00105196|Other Pre-specified|MADRS Remission|Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14||||participants|||Number
2847063|NCT00105196|Other Pre-specified|Clinical Global Impression (CGI)-Improvement Response|Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).|Baseline (Week 8) and Week 14||||Participants|||Number
2847064|NCT00105196|Other Pre-specified|MADRS Response|Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14||||participants|||Number
2847065|NCT00105196|Secondary|Mean Change in SDS Item Score (Work/School)|Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
2847066|NCT00105196|Secondary|Mean Change in SDS Item Score (Family Life)|Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
2847067|NCT00105196|Secondary|Mean Change in SDS Item Score (Social Life)|Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
2847068|NCT00105196|Secondary|Mean Change in Sheehan Disability Scale (SDS) Mean Score|Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
2847069|NCT00105196|Primary|Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)|Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14||||units on a scale||Standard Error|Mean
2847070|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Flow 25-75||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Liters/second||Full Range|Median
2847071|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Volume in 1 Second||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Liters||Full Range|Median
2847072|NCT00105183|Secondary|Pulmonary Function Test, Forced Vital Capacity||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Liters||Full Range|Median
2847073|NCT00105183|Secondary|Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit|||Meters||Full Range|Median
2847074|NCT00105183|Secondary|Number of Participants With Severe Adverse Events||12 months|Safety population|||participants|||Number
2847075|NCT00105183|Secondary|Number of Participants With Infections and Infestations||12 months|Safety population|||participants|||Number
2847076|NCT00105183|Secondary|Number of Participants With Acute Rejection||12 months|ITT|||participants|||Number
2847077|NCT00105183|Secondary|Number of Participants With Death or Graft Loss Post-transplant||12 months|ITT population|||participants|||Number
2847078|NCT00105183|Primary|Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)||12 months|ITT. During the interim analysis the 5 mg/kg arm was dropped and it was showed that the study was insufficiently powered so the main focus of study shifted to safety endpoints. Data is based on local lung biopsy readings for efficacy failure instead of central readings|||participants|||Number
2847079|NCT00105157|Secondary|Number of Patients Discontinued With LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847080|NCT00105157|Secondary|Number of Patients With Serious Drug-related LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847081|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847082|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847183|NCT00104572|Primary|Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density|bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo|1 year||||g/cm2||Standard Deviation|Mean
2847083|NCT00105157|Secondary|Number of Patients With Serious LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847084|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847085|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847086|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847087|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847088|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847089|NCT00105157|Secondary|Number of Patients That Died by 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847090|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847091|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847092|NCT00105157|Secondary|Number of Patients With Serious CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847093|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.|||Participants|||Number
2847094|NCT00105157|Other Pre-specified|Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
2847095|NCT00105157|Other Pre-specified|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2847096|NCT00105157|Post-Hoc|Number of Patients With Virologic Responses at Week 168 in Combined Substudies|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168.|168 weeks|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||Participants|||Number
2847097|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 96 Weeks||96 weeks|"All patients who took study medication and had~any laboratory tests performed were included in the analysis."|||Participants|||Number
2847098|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks||96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2847099|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|96 weeks||||Participants|||Number
2847100|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2847101|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847102|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847103|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847104|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847105|NCT00105157|Secondary|Number of Patients That Died by 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847106|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847107|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847108|NCT00105157|Secondary|Number of Patients With Serious CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847109|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847110|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2847111|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2847112|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2847113|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
2847114|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847115|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847116|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847117|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847118|NCT00105157|Secondary|Number of Patients That Died by 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847119|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847120|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847121|NCT00105157|Secondary|Number of Patients With Serious CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847122|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
2847123|NCT00105157|Secondary|Change From Baseline in CD4 Cell Count at Week 24|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy.|||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
2847124|NCT00105157|Secondary|Number of Patients With Virologic Responses at Week 24|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24|24 weeks|All patients who took study medication and had HIV RNA tests performed were included in the analysis.|||Participants|||Number
2847125|NCT00105157|Primary|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24|Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients|Baseline and Week 24|Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA <400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy|||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
2847126|NCT00105079|Secondary|Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters|Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported.|baseline and all study visits (Up to Week 52)|Safety population included all randomized patients who received at least one dose of study medication.|||participants|||Number
2847127|NCT00105079|Secondary|Number of Participants Assessed for Adverse Events (AEs)|Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.|reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)|Safety population included all randomized patients who received at least one dose of study medication|||participants|||Number
2847128|NCT00105079|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) - (CD4+ count at baseline).|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.|||cells/mm^3||95% Confidence Interval|Median
2847129|NCT00105079|Secondary|Change From Baseline in HIV-1 RNA Viral Load|Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline)|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.|||copies/mL||95% Confidence Interval|Mean
2847130|NCT00105079|Secondary|Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL|"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported."|Week 48|Intent-to-Treat Population|||participants|||Number
2847131|NCT00105079|Primary|Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported."|Week 48|intent-to-treat (ITT) Population|||participants|||Number
2847132|NCT00105066|Post-Hoc|Homa Insulin Sensitivity|Homeostatic Model Assessment of insulin sensitivity|4.5 months|Participants with complete data.|||HOMA Score||Standard Deviation|Mean
2847133|NCT00105066|Primary|Change in Flow Mediated Dilation (FMD)|to evaluate improvement in endothelial function|Baseline and 4.5 months|Participants with complete data.|||percentage change in diameter||Standard Deviation|Mean
2847134|NCT00105066|Primary|Change in Arterial Stiffness Compared to Baseline||Baseline and 4.5 months||||meters / second||Standard Deviation|Mean
2847135|NCT00105027|Secondary|Adverse Ocular Outcomes||12 months|Participants experiencing an adverse event|||events|||Number
2847136|NCT00105027|Secondary|Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography||12 months|Participants who attended month 12 visit|||um||Inter-Quartile Range|Median
2847137|NCT00105027|Secondary|Changes From Baseline in Best-corrected ETDRS Visual Acuity Score||12 months|Participants who attended month 12 visit|||letters read||95% Confidence Interval|Mean
2847138|NCT00105027|Primary|The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit|Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.|Change from baseline to 12 months||||Participants|||Number
2847139|NCT00105001|Secondary|Number of Participants Surviving Without Progression|"Number of patients with progression-free survival, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|2 Years post-transplant|Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.|||Participants|||Count of Participants
2847140|NCT00105001|Secondary|Number of Participants Surviving Overall|"Number of patients surviving, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|1 Year post-transplant|Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.|||Participants|||Count of Participants
2847141|NCT00105001|Secondary|Number of Participants Utilizing High-Dose Corticosteroids|"Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant|Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.|||Participants|||Count of Participants
2847142|NCT00105001|Secondary|Number of Non-Relapse Mortalities|"Percentage of NRM as estimated by cumulative incidence methods with competing risks.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|200 days after transplant|Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.|||Participants|||Count of Participants
2847143|NCT00105001|Primary|Number of Participants With Grades II-IV Acute GVHD|"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|150 days after transplant|Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.|||Participants|||Count of Participants
2847144|NCT00104884|Primary|Proportion of Patients With Response to Depsipeptide|"Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR).~Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years|The study was terminated early due to slow accrual with final accrual of 4 patients. There are no plans to conduct a formal analysis for any outcome measure.|||percentage of participants||95% Confidence Interval|Number
2847145|NCT00104871|Secondary|Progression-free Survival Assessed by RECIST|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|At 6 months|Two participants were not evaluable for response.|||Participants|||Count of Participants
2847146|NCT00104871|Primary|Participant Tumor Response Assessed by RECIST|Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))|Two participants were not evaluable for response.|||participants|||Number
2847147|NCT00104871|Primary|Objective Tumor Response Rate Assessed by RECIST|Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks|Two participants were not evaluable for response.|||participants|||Number
2847220|NCT00104104|Primary|The Number of Participants With Disease Progression||24 Months|Safety Population; enrolled patients who received at least one dose of study medication.|||Participants|||Number
2847148|NCT00104858|Secondary|Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse|Number of participants without progressive disease and surviving at one year. Participants with FCgammaRIIIa receptor vs participants without FCgammaRIIIa receptor.|1 Year|Number of patients with PK sample testing. 14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847149|NCT00104858|Secondary|Number of Patients Achieving Complete Response and Partial Response (Overall Response Rate)|"Complete Remission (CR):~Imaging studies (Xray, CT, MRI) (nodes, liver, and spleen): Normal Peripheral blood by flow cytometry: No clonal lymphocytes Bone marrow by morphology: No nodules; or if present, nodules are free from CLL cells by immunohistochemistry Duration: ≥2 months~CR with minimal residual disease Peripheral blood or bone marrow by flow cytometry: >0 - <1 CLL cells/1000 leukocytes (0.1%)~Partial Remission (PR):~Both criteria:~Absolute lymphocyte count in peripheral blood: ≥50% decrease Physical exam/Imaging studies (nodes, liver, and/or spleen): ≥50% decrease Duration: ≥2 months"|Up to 1 year|14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847150|NCT00104858|Secondary|Rituxan Concentration|Median rituxan level at days 60, 84, 180, and 1 year.|Days 60, 84, 180, and 1 year|Number of participants varies by interval based on the number of samples received.14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||ug/ml||Full Range|Median
2847151|NCT00104858|Secondary|Number of Participants With Treatment-related Mortality|Number of subjects expired without disease progression/relapse.|Up to 1 year|14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847152|NCT00104858|Secondary|Number of Participants With Regimen-related Toxicity and Infections|Reported using the adapted National Cancer Institute Common Toxicity Criteria.|Within the first 100 days|14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847153|NCT00104858|Secondary|Number of Participants With Grade II-III and III-IV Acute GVHD and Chronic GVHD|"Number of patients who developed acute GVHD post-transplant. Grade I +1 to +2 skin rash, No gut or liver involvement Grade II +1 to +3 skin rash, +1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or +2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death~The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD."|Up to 1 year|14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847154|NCT00104858|Secondary|Graft-versus-leukemia Analysis by Mechanism of Disease Resistance in Relapsed or Non-responding Patients and Isolation of Donor Cytotoxic T Lymphocytes Specific for Host Minor Histocompatibility Antigens||Day 84|Lack of funds to support sample collection and analysis||||||
2847155|NCT00104858|Secondary|Number of Participants With Relapse/Progression|"Relapse/Progression criteria for CLL~Progressive disease:~≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~Relapsed disease:~Criteria of progression occurring 6 months after achievement of complete or partial remission."|Day 84|14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847156|NCT00104858|Secondary|Comparison of Survival, Serious Adverse Events, and B-cell and T-cell Immune Reconstitution With Historical Data||At 18 months|Lack of funds to support sample collection analysis||||||
2847157|NCT00104858|Primary|Overall Survival|Number of participants surviving post-transplant|At 18 months|14 subjects were enrolled prior to the addition of rituximab. These subjects are counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2847158|NCT00104728|Secondary|Frequency of Toxicity Related to Study Treatment|Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. To estimate the safety, tolerability, and feasibility of preoperative ZD1839 in patients with resectable Stage IA/IB, II and selected IIIA NSCLC by evaluating toxicity and operability after preoperative ZD1839.|3 years|||||||
2847159|NCT00104728|Primary|Overall Response Rate (ORR)|Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.|3 years|||||||
2847160|NCT00104650|Secondary|Hypercalcemia|Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Participants|||Number
2847161|NCT00104650|Secondary|Skeletal Related Events|Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase.|||Participants|||Number
2847162|NCT00104650|Secondary|Time to First Skeletal Related Event|Time from study day 1 to first Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.|||Participants|||Number
2848015|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2847163|NCT00104650|Secondary|Percent Change of Serum CTX From Baseline to Week 25|Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx and had available data.|||Percent change||Standard Deviation|Mean
2847164|NCT00104650|Secondary|Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol|Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.|Day 1, week 25|Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.|||Participants|||Number
2847165|NCT00104650|Secondary|Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol|Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Days||Inter-Quartile Range|Median
2847166|NCT00104650|Secondary|Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25|Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Percent change||Standard Deviation|Mean
2847167|NCT00104650|Secondary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25|Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.|25 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Participants|||Number
2847168|NCT00104650|Primary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13|Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.|13 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.|||Participants|||Number
2847169|NCT00104637|Secondary|O2 Saturation at Peak Exercise|O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.|Period 1 and Period 3 ( within 8 weeks)||||percentage of oxygen saturation||95% Confidence Interval|Least Squares Mean
2847170|NCT00104637|Secondary|Oxygen Pulse|Oxygen pulse during Cardiopulmonary exercise test at peak exercise.|Period 1 and Period 3 ( within 8 weeks)||||ml/beat||95% Confidence Interval|Least Squares Mean
2847171|NCT00104637|Secondary|A-a Gradient (Alveolar-arterial Gradient)|A-a gradient was measured with ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)||||mm Hg||95% Confidence Interval|Least Squares Mean
2847172|NCT00104637|Secondary|Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)|Partial Pressure of Oxygen in ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)||||mm Hg||95% Confidence Interval|Least Squares Mean
2847173|NCT00104637|Secondary|Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)|Partial pressure of carbon dioxide in ABG performed breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)||||mm Hg||95% Confidence Interval|Least Squares Mean
2847174|NCT00104637|Secondary|Diffusing Capacity of Carbon Monoxide (DLCO)|Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.|Period 1 and Period 3 ( within 8 weeks)||||ml/min/torr||95% Confidence Interval|Least Squares Mean
2847175|NCT00104637|Secondary|Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)|Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.|Period 1 and Period 3 ( within 8 weeks)||||Scores on a scale||95% Confidence Interval|Least Squares Mean
2847176|NCT00104637|Secondary|Forced Expiratory Volume in the First Second (FEV1 )|The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.|Period 1 ( 4 weeks)||||liters||95% Confidence Interval|Least Squares Mean
2847177|NCT00104637|Primary|VO2 Peak (Oxygen Consumption at Peak Exercise)|Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.|Period 1 and Period 3 ( within 8 weeks)||||ml/kg/min||95% Confidence Interval|Least Squares Mean
2847178|NCT00104637|Primary|6 Minute Walk Distance|The distance a subject walked within 6 minutes was measured and documented.|Period 1 and Period 3 ( within 8 weeks)||||meters||95% Confidence Interval|Least Squares Mean
2847179|NCT00104637|Secondary|Pulmonary Function FVC (Forced Vital Capacity)|Data to calculate results for FVC was based on Period 1.|Period 1 (4 weeks)||||liters||95% Confidence Interval|Least Squares Mean
2847180|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function|"rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo.~Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point."|1 year||||cc||Standard Error|Mean
2847181|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism|"Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more.~Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point."|1 year||||score on a scale||Standard Error|Mean
2847182|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release|Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo|1 year||||ng/ml/8h||Standard Error|Mean
2847184|NCT00104520|Other Pre-specified|Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||μg/mL|||Number
2847185|NCT00104520|Other Pre-specified|Number of Participants With Other Pathogens|"Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.~Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported."|Day 0 and Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||Participants|||Number
2847186|NCT00104520|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
2847187|NCT00104520|Secondary|Number of Hospitalization Days|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).|Day 0 to Day 84|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.|||Days||Standard Deviation|Mean
2847188|NCT00104520|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)|"Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.~FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.~The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
2847189|NCT00104520|Secondary|Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to tx who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to AE or study drug intolerance. For all other missing data, LOCF method was used.|||Units on a scale||Standard Error|Least Squares Mean
2847190|NCT00104520|Primary|Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics|The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.|Day 0 to Day 84 (end of study)|Analysis based on intents to treat (ITT) population (all participants randomized to treatment who received at least part of one dose of study drug).|||Days||95% Confidence Interval|Median
2847191|NCT00104416|Secondary|Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine|Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.|Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)|PK Population: Number of participants analyzed for PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.||||||
2847192|NCT00104416|Secondary|Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze [0] to high chance of dozing [3]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 and 51 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847316|NCT00102960|Secondary|Time to First Hospitalization|To compare time to first hospitalization in the three randomized arms (infants who received early ART in Arms 2 and 3 and those who received deferred ART in Arm 1). Not all participants were hospitalized and thus the upper limits could not be evaluated.|From randomization up to 4.8 years||||Weeks||Full Range|Median
2847193|NCT00104416|Secondary|Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase|The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 68 and 67 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847194|NCT00104416|Secondary|Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase|The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847195|NCT00104416|Secondary|Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase|The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847196|NCT00104416|Secondary|Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants' mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847197|NCT00104416|Secondary|Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase|The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 64 and 59 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847198|NCT00104416|Secondary|Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase|The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 53 and 57 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.|||points on a scale||Standard Error|Least Squares Mean
2847199|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.|||participants|||Number
2847234|NCT00103857|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.|||Percent||95% Confidence Interval|Least Squares Mean
2847200|NCT00104416|Secondary|Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase|Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP: all participants who took at least one dose of study medication during the CP and had at least one post baseline seizure assessment during the CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.|||percent change||Full Range|Median
2847201|NCT00104416|Secondary|Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase|Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Participant satisfaction was not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.|||participants|||Number
2847202|NCT00104416|Secondary|Number of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase|The investigators rated the participants' overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration [1], moderate deterioration [2], mild deterioration [3], no change [4], mild improvement [5], moderate improvement [6], or marked improvement [7]), the investigators assessed the participants' status compared to their condition prior to initiating study medication.|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Overall clinical status not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.|||participants|||Number
2847203|NCT00104416|Secondary|Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase|Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population|||kilograms||Full Range|Median
2847204|NCT00104416|Secondary|Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase|50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a >=50% reduction in seizure frequency following exposure to at least 1 week of study drug.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|ITT Population|||participants|||Number
2847205|NCT00104416|Secondary|Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency.|Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase as a result they were not counted for this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.|||percent change||Full Range|Median
2847206|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline.|Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase, as a result they were not counted in this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.|||participants|||Number
2847207|NCT00104416|Primary|Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment in the Double-Blind Treatment Phase. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase.|||percent change||Full Range|Median
2847247|NCT00103844|Secondary|MCyR at Any Time Prior to Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.||||Participants|||Number
2847208|NCT00104299|Post-Hoc|Number of Subjects Experiencing Serious Adverse Events|Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.|Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)|Intent-to-treat|||participants|||Number
2847209|NCT00104299|Secondary|Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
2847210|NCT00104299|Secondary|Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
2847211|NCT00104299|Secondary|The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
2847212|NCT00104299|Secondary|The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat|||Days||95% Confidence Interval|Number
2847213|NCT00104299|Secondary|Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization|"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|6 months post-randomization|Safety Sample|||participants|||Number
2847214|NCT00104299|Secondary|Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy|The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident|Through common close-out (defined as 18 months after the last participant is enrolled in the trial)|Safety Sample|||participants|||Number
2847215|NCT00104299|Primary|Disease Remission|A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.|6 months post-randomization|Intent-to-treat (ITT) sample with worst case imputation|||Participants|||Number
2847216|NCT00104247|Primary|Change in Blood Phenylalanine Levels From Baseline to Week 6.||baseline to week 6||||micromole per liter||Standard Deviation|Mean
2847217|NCT00104234|Secondary|Change in Urinary Glycosaminoglycans (GAG) Level|Mean change in urinary GAG level for the first 72 weeks of rhASB treatment. For the rhASB/rhASB group, mean change was calculated for Week 72 -Baseline. For the placebo/rhASB, mean change was calculated for Week 96 - Week 24.|72 weeks|rhASB/rhASB and placebo/rhASB groups were combined for the analysis, representing 72 weeks of rhASB treatment in each group.|||microgram/mg creatinine||Standard Deviation|Mean
2847218|NCT00104234|Secondary|3-Minute Stair Climb|Mean change in number of stairs climbed per minute in 3 minutes. Mean change is the mean difference between the 3-Minute Stair Climb at 96 weeks and that measured before first ever treatment with rhASB. Mean change is calculated for Week 96 - Baseline for the rhASB/rhASB group and for Week 96 - Week 24 for the placebo/rhASB group.|Baseline ASB-03-05 through week 96 of ASB-03-06.|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except 1 subject from the placebo/rhASB group who missed the Week 96 measurement.|||stairs/min||Standard Deviation|Mean
2847219|NCT00104234|Primary|12-Minute Walk Test|Mean change in meters walked in 12 minutes. Mean change is the mean difference between the 12-Minute Walk Test at 96 weeks and that measured before first ever treatment with rhASB. For the rhASB/rhASB group, mean change is calculated for Week 96 - Baseline. For the placebo/rhASB group, mean change is calculated for Week 96 - Week 24.|Baseline of ASB-03-05 through week 96 of ASB-03-06|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except the 1 subject from the rhASB/rhASB group and 1 subject from the placebo/rhASB group who missed the Week 96 measurement.|||meters||Standard Deviation|Mean
2847221|NCT00104104|Secondary|Zoledronic Acid Concentrations|Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.|24 months|The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.|||ng/mL||Standard Deviation|Mean
2847222|NCT00104104|Secondary|Time to First Significant Increase in Serum Creatinine|Median time to event in participants who had a clinically relevant increase in serum creatinine.|Up to 24 months|Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.|||weeks||Full Range|Median
2847223|NCT00104104|Secondary|The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months|Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 24 Months|Safety Population; enrolled patients who received at least one dose of study medication.|||Participants|||Number
2847224|NCT00104104|Primary|The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months|The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 12 Months|Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.|||Participants|||Number
2847225|NCT00104052|Primary|Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment|SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment|Up to 48-week treatment duration. Follow-up of 24 weeks.|Carry Forward analysis of participants who received at least one dose of study medication. This dataset includes one subject with undetectable HCV-RNA at Follow-up Week 12 (FW 12) but missing data at FW 24; this subject was considered a sustained responder in the Carry Forward analysis.|||Participants|||Number
2847226|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
2847227|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
2847228|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104|HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.|||Percent||95% Confidence Interval|Least Squares Mean
2847229|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
2847230|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
2847231|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.|||Percent||95% Confidence Interval|Least Squares Mean
2847232|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.|||mg/dL||95% Confidence Interval|Least Squares Mean
2847233|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.|||mg/dL||95% Confidence Interval|Least Squares Mean
2847248|NCT00103844|Primary|Number of Participants With Major Cytogenetic Response (MCyR) at Week 12|Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).|Week 12|All randomized subjects|||Participants|||Number
2847235|NCT00103844|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Number of participants from which blood samples were collected for population PK studies.|Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.|Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report.|||participants|||Number
2847236|NCT00103844|Secondary|Health-Related Quality of Life Prior to Crossover|Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.|Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed.|||Units on a Scale|||Number
2847237|NCT00103844|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously from baseline through 2 years|All treated participants|||Participants|||Number
2847238|NCT00103844|Secondary|Cytogenetic Response After Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements|Participants evaluable for after crossover response|||Participants|||Number
2847239|NCT00103844|Secondary|CHR After Crossover|Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.|Participants evaluable for response after crossover|||Participants|||Number
2847240|NCT00103844|Secondary|Major Molecular Response (MMR)|Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.|Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.|Participants assessed for MMR only|||participants|||Number
2847241|NCT00103844|Secondary|Time to CHR Prior to Crossover|Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.|Number of participants achieving CHR in each treatment group|||weeks||Full Range|Median
2847242|NCT00103844|Secondary|Duration of Complete Hematologic Response (CHR)|Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|12 months, 24 months|Number of participants achieving CHR in each treatment group|||percentage of participants|||Number
2847243|NCT00103844|Secondary|Complete Hematologic Response (CHR) at Any Time Prior to Crossover|Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.||||Participants|||Number
2847244|NCT00103844|Secondary|Time to MCyR Prior to Crossover|Median time from first dosing date to date of MCyR|Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.|Population consists of the number of responders in each treatment group|||months||Full Range|Median
2847245|NCT00103844|Secondary|Duration of MCyR at 24 Months|Percentage of participants who achieved MCyR and did not progress at 24 months.|24 Months|In the imatinib group, the 24 months timepoint was beyond the maximum observed time.|||Percentage of Participants|||Number
2847246|NCT00103844|Secondary|Duration of MCyR at 12 Months and 18 Months|Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.|12 months, 18 months||||percentage of participants.|||Number
2847249|NCT00103740|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||participants|||Number
2847250|NCT00103740|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||participants|||Number
2847251|NCT00103740|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||participants|||Number
2847252|NCT00103740|Secondary|Change in Pain Interference at Day 182|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||units on a scale||Standard Deviation|Mean
2847253|NCT00103740|Secondary|Change in Pain Severity at Day 182|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||units on a scale||Standard Deviation|Mean
2847254|NCT00103740|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).|Day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.|||participants|||Number
2847255|NCT00103740|Secondary|Time to First Therapeutic Response|Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.|||days||Inter-Quartile Range|Median
2847256|NCT00103740|Secondary|Relative Change in Urine α-CTx in ug/mmol at Day 10|The percent change in urine α-CTx from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||percent change||Standard Deviation|Mean
2847257|NCT00103740|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||percent change||Standard Deviation|Mean
2847258|NCT00103740|Secondary|Relative Change in Serum Alkaline Phosphatase in U/L at Day 28|The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.|Baseline and 28 days|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.|||percent change||Standard Deviation|Mean
2847259|NCT00103740|Primary|Number of Patients Who Had Therapeutic Response at 6 Months|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.|Baseline, 6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.|||participants|||Number
2847260|NCT00103662|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant|||proportion of participants|||Number
2847261|NCT00103662|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant|||proportion of participants|||Number
2847262|NCT00103662|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant|||proportion of participants|||Number
2847276|NCT00103610|Secondary|Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-treat Population|||proportion of participants|||Number
2847263|NCT00103662|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant|||Days||Inter-Quartile Range|Median
2847264|NCT00103662|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant.|||Days||Inter-Quartile Range|Median
2847265|NCT00103662|Secondary|Median Number of Days to ≥6*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.|up to Day 8|Intent-to-treat population|||Days||Inter-Quartile Range|Median
2847266|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population|||proportion of participants|||Number
2847267|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population|||proportion of participants|||Number
2847268|NCT00103662|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.|||participants|||Number
2847269|NCT00103662|Primary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.|up to Day 6|Intent-to-Treat Population|||proportion of participants|||Number
2847270|NCT00103610|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant|||proportion of participants|||Number
2847271|NCT00103610|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant|||proportion of participants|||Number
2847272|NCT00103610|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant|||proportion of participants|||Number
2847273|NCT00103610|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant|||Days||Inter-Quartile Range|Median
2847274|NCT00103610|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant.|||Days||Inter-Quartile Range|Median
2847275|NCT00103610|Secondary|Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.|up to Day 8|Intent-to-Treat Population.|||Days||Inter-Quartile Range|Median
2847277|NCT00103610|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.|||participants|||Number
2847278|NCT00103610|Primary|Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|Days 5 to 8|Intent-to-Treat Population|||proportion of participants|||Number
2847279|NCT00103506|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)|Safety population included all the participants who received at least one dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2847280|NCT00103506|Secondary|Overall Survival|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)||||months||95% Confidence Interval|Median
2847281|NCT00103506|Primary|Time to Progression (TTP)|Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])|Intent-to-treat (ITT) included all the randomized participants.|||Months||95% Confidence Interval|Median
2847282|NCT00103376|Secondary|Disease-free Interval|This will only be analyzed if sample size warrants the analysis.|3 months after combined treatment|data was not collected for this outcome measure.||||||
2847283|NCT00103376|Secondary|Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0||From start of treatment until end of study, up to 6 months||||participants|||Number
2847284|NCT00103376|Primary|Time to PSA Progression|PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of >= 1.0 ng/ml.|From on study until time of PSA progression for up to two years|Only patients with a CR were included in the analysis. No patients in Part A had a complete response. Time to progression for Part B only and Part A+Part B was calculated together. The information for the confidence interval is not available.|||months||95% Confidence Interval|Median
2847285|NCT00103376|Primary|Prostate-specific Antigen (PSA) Response||3 months after the start of treatment||||participants|||Number
2847286|NCT00103311|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm.|From the date of registration to the date of death, assessed up to 12 months||||months||95% Confidence Interval|Median
2847287|NCT00103311|Secondary|Progression-free Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of registration to the date of documented PSA progression, assessed up to 6 months||||weeks||95% Confidence Interval|Median
2847288|NCT00103311|Primary|Objective Response (CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years||||participants|||Number
2847289|NCT00103285|Secondary|Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)|Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|Patients on the two arms being compared got similar therapy. All patients included in this analysis are MRD negative. SR-Average patients who were CNS2 at diagnosis were excluded in order to have comparable patient cohorts. SR-Low patients are TEL/Trisomy positive while SR-Average patients are TEL/Trisomy negative.|||Percent probability||95% Confidence Interval|Number
2847290|NCT00103285|Secondary|Event-free Survival (EFS) for SR-High Patients.|Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|CCR: Complete Continuous Remission, where time to event is defined as the time from start of consolidation therapy to first event or date of last follow up for those who did not experience an event. All patients enrolled on the SR-High were used in this analysis regardless of completion of therapy.|||percent probability||95% Confidence Interval|Number
2847291|NCT00103285|Secondary|Optimal Time Point for Advance Health Related Quality of Life Intervention|Percentage of patients with elevated Anxiety.|At 1 month after diagnosis and 3 months post-therapy.|Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.|||Percentage of participants||95% Confidence Interval|Number
2847292|NCT00103285|Secondary|Early Marrow Status (EMS) by MRD Status End Induction (Day 29)|Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)|Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.|Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.|||Participants|||Count of Participants
2847293|NCT00103285|Secondary|Overall Survival Probability (OS) According to Induction Day 29 MRD Status|Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.|Overall Survival Probability of 6 years|4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29.|||percent probability||95% Confidence Interval|Number
2847294|NCT00103285|Secondary|Event-Free Survival Probability According to MRD Status End Induction (Day 29)|Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|MRD at Day 29 of therapy|4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29|||Percent Probability||95% Confidence Interval|Number
2847295|NCT00103285|Secondary|Health-related Quality of Life Relative to Physical, Social and Emotional Impairment|To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.|At 1, 6 and 12 months after diagnosis and, 3 months post-therapy|This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).|||Percentage of participants||95% Confidence Interval|Number
2847296|NCT00103285|Primary|Event-free Survival (EFS) for SR-Low Patients|Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|Only eligible patients are included in the analysis.|||Percent probability||95% Confidence Interval|Number
2847297|NCT00103285|Primary|Event-free Survival (EFS) for SR-Average ALL Patients|EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.|6 years|Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.|||percent probability||95% Confidence Interval|Number
2847298|NCT00103259|Secondary|Overall Survival on Step 1|Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.|Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years|61 eligible and treated patients were included in the analysis|||months||95% Confidence Interval|Median
2847299|NCT00103259|Secondary|Progression-free Survival on Step 1|Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.|Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|61 eligible and treated patients were included in the analysis|||months||95% Confidence Interval|Median
2847300|NCT00103259|Secondary|Response Rate on Step 2|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years|10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis|||percentage of participants||90% Confidence Interval|Number
2847301|NCT00103259|Primary|Response Rate on Step 1|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years|61 eligible and treated patients were included in the analysis|||percentage of participants||90% Confidence Interval|Number
2847302|NCT00103207|Secondary|Time to Progression by Smoking Status|Medians of time to progression by smoking status are reported.|Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.|||Months||95% Confidence Interval|Median
2847317|NCT00102960|Secondary|Duration of Hospitalisation|This is the total number of days spent in hospital by the participants and is reported per arm|4.8 years, the study duration||||Days|||Number
2847303|NCT00103207|Secondary|Overall Survival by Smoking Status|Medians of overall survival by smoking status are reported.|Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.|||Months||95% Confidence Interval|Median
2847304|NCT00103207|Secondary|Time to Progression|Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in the analysis.|||Months||95% Confidence Interval|Median
2847305|NCT00103207|Secondary|Overall Survival|Overall survival is defined as the time from registration to death.|Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included.|||Months||95% Confidence Interval|Median
2847306|NCT00103207|Primary|Objective Response Rate (Proportion of Patients With Objective Response)|Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in this analysis.|||Proportion||90% Confidence Interval|Number
2847307|NCT00103194|Secondary|Relationship Between Progression-free Survival and EGFR Expression Levels|The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.|||months||90% Confidence Interval|Median
2847308|NCT00103194|Secondary|Progression-free Survival Rate at 2 Years|Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.|||percentage of participants||90% Confidence Interval|Number
2847309|NCT00103194|Secondary|The Change in PSA Slope With GW572016 (Lapatinib)|PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years|One patient who withdrew from study after receiving 4 days of treatment and did not have any follow-up PSA measurements was excluded from this analysis, so the number of participants analyzed is 34.|||log (PSA)/month||Standard Error|Mean
2847310|NCT00103194|Primary|Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level|"PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.~CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.~PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started protocol treatment|||participants|||Number
2847311|NCT00103142|Secondary|Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay|CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.|13 weeks||||participants|||Number
2847312|NCT00103142|Primary|Recurrence-free Survival at 2 Years|Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.|2 years||||participants|||Number
2847313|NCT00103116|Secondary|Number of Participants Alive Five Years Post Vaccine|Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine|five years post vaccine||||participants|||Number
2847314|NCT00103116|Primary|Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization|Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.|six months post vaccine||||participants with immunological response|||Number
2847315|NCT00103012|Primary|Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.|The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).|2 weeks|Data was analyzed from all subjects who completed a particular sampling period.|||mcg*hr/mL||90% Confidence Interval|Geometric Mean
2847318|NCT00102960|Secondary|Hospitalization Rates|Hospitalisation rates in the three arms enrolled in the CHER study|4.8 years||||Events per 100 person years|||Number
2847319|NCT00102960|Secondary|Time to Death Alone or Death Plus Life Threatening Stage C Events or HIV Events Associated With Permanent End-organ Damage.|This was a composite endpoint in which the number of children experiencing the events is reported. The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore, we report the number of participants experiencing the events per Arm.|4.8 years||||Participants|||Count of Participants
2847320|NCT00102960|Secondary|Number of Participants With Indicated Viral Resistance Mutations at the Time of Failure of First Line Therapy|Resistance testing was performed on samples with a VL≥1000 c/ml together with the matched baseline sample, if available. Reverse transcriptase (NRTI and NNRTI) and protease (PI) inhibitor mutations were analysed using a validated in-house population-based sequencing assay and the IAS 2011 mutation list.|4.8 years|Mutations presented descriptively were 1) Protease inhibitor mutations and 2) Met184Val mutations were reported. Only 32 participants with viral load above 1,000 copies/ml at their last visit while on treatment were analysed.|||Participants|||Count of Participants
2847321|NCT00102960|Secondary|Time From Randomization to Starting or Needing to Start Continuous Therapy|Time from randomization to starting (deferred therapy Arm) or needing to start continuous therapy (early therapy 40 or 96 weeks)|4.8 years||||Weeks||Full Range|Median
2847322|NCT00102960|Secondary|Total Occurrence of Grade 3 or 4 Laboratory Events||From randomization up to 4.8 years||||Count of events|||Number
2847323|NCT00102960|Secondary|Total Occurrence of Grade 3 or 4 Clinical Events|This was a secondary outcome measure that assessed the total count of Grade 3 or 4 (clinical or laboratory) adverse events.|4.8 years|This analysis was only performed on the primary groups including a total of 377 participants|||Count of events|||Number
2847324|NCT00102960|Secondary|Number of Children Experiencing Severe CDC Stage B or Stage C Disease or Death (Cumulative After 3.5 Years)|The outcome measure is defined as a number because it represents the number of children that experienced severe CDC Stage B or Stage C disease or death as defined in the outcome measure title above|Occurrence of severe CDC Stage B or Stage C disease or death (cumulative after 3.5 years), whichever came first, was assessed from randomization up to at least 3.5 years.||||Participants|||Count of Participants
2847325|NCT00102960|Primary|Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart)|This was part of the primary outcome measure that was a composite endpoint that included confirmed HIV-1 RNA value of at least 10,000 copies per/ml recorded on two consecutive separate occasions after 24 weeks of treatment (initial therapy or restart).|Virological failure was assessed from randomization through the entire study duration of 4.8 years.||||Participants|||Count of Participants
2847326|NCT00102960|Primary|Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy.|This included development of severe CDC Stage B or Stage C disease.This was part of the primary outcome measure that was a composite endpoint|Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.||||Participants|||Count of Participants
2847327|NCT00102960|Primary|Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity|Development of toxicity requiring more than one drug substitution within the same class or a switch to a new class of drugs (regimen-limiting toxicity failure) or requiring a permanent treatment discontinuation. This was part of the primary outcome measure that was a composite endpoint.|Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.||||Participants|||Count of Participants
2847328|NCT00102960|Primary|Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart)|This was part of the primary outcome measure above. The primary outcome was a composite endpoint. The primary outcome analysis only considered the initially enrolled children that were 377 in total (ART-Deferred n=125, Early therapy 40 weeks n=126 and Early therapy 96 weeks n=126). This was part of the primary outcome measure that was a composite endpoint.|This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.||||Participants|||Count of Participants
2847329|NCT00102960|Primary|Time to Failure of First Line Therapy or Death|To compare time to failure of first line ART (due to clinical, virological or immunological disease progression, or regimen-limiting ART toxicities) or death among three randomized arms (infants who receive early ART in Arms 2 and 3 and infants in whom ART is deferred until clinical or immunological disease progression in Arm 1) during the study (up to 4.8 years). The number of participants experiencing the events did not reach the 50% survival and thus median time-to-event is not be presented. Therefore we report the number of participants experiencing the events per Arm.|From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years|In the analysis of failure of first-line therapy, children enrolled in the ART-Deferred group were used as the reference category in the hazard ratio analysis.|||Participants|||Count of Participants
2847330|NCT00102804|Secondary|Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.|Baseline through 30 days post discontinuation of study treatment (up to 39 Months)|Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.|||units on a scale||Standard Deviation|Mean
2847331|NCT00102804|Secondary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 41 Months)|Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.|||participants|||Number
2847332|NCT00102804|Secondary|Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)|Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)*100.|Baseline to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2847333|NCT00102804|Secondary|Time to Worsening of Symptoms (TWS)|TWS was the elapsed time from the date of randomization to the first date of worsening [defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.|Randomization to worsening of each LCSS item (up to 39 months)|Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.|||months||95% Confidence Interval|Median
2847334|NCT00102804|Secondary|Time to Objective Progressive Disease (TPD)|TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 145, 40 participants in the pemetrexed and placebo treatment arms, respectively.|||months||95% Confidence Interval|Median
2847335|NCT00102804|Secondary|Overall Survival (OS) Time|OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.|Randomization to date of death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.|||months||95% Confidence Interval|Median
2847336|NCT00102804|Primary|Progression-Free Survival (PFS) Time|PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD or death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.|||months||95% Confidence Interval|Median
2847337|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|24 months|Intent to treat population|||infections per cycle||Full Range|Median
2847338|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|6 months|Intent to treat population|||infections per cycle||Full Range|Median
2847339|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population|||participants|||Number
2847340|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population|||participants|||Number
2847341|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population|||participants|||Number
2847342|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population|||participants|||Number
2848016|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 3|Laboratory hematology eosinophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2847343|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)|The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.|24 months|Intent to treat population|||x10^9/L||Full Range|Median
2847344|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)|The difference between ANC values at the end of the initial study period minus the ANC values at baseline.|6 months|Intent to treat population|||x10^9/L||Full Range|Median
2847345|NCT00102687|Secondary|Baseline Absolute Neutrophil Count (ANC) Values|The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population|||x10^9/L||Full Range|Median
2847346|NCT00102687|Secondary|Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)|The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.|24 months|Intent to treat population|||x10^9/L||Full Range|Median
2847347|NCT00102687|Secondary|Change From Baseline in Platelets at the End of Initial Study Period (6 Months)|The difference between platelet values at the end of the initial study period minus the platelet values at baseline.|6 months|Intent to treat population|||x10^9/L||Full Range|Median
2847348|NCT00102687|Secondary|Baseline Platelet Values|The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population|||x10(9)/L||Full Range|Median
2847349|NCT00102687|Secondary|Change From Baseline in Hemoglobin at the End of the Maintenance Study Period|The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.|24 months|Intent to treat population|||g/L||Full Range|Median
2847350|NCT00102687|Primary|Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period|Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.|24 months|Intent to treat population.|||participants|||Number
2847351|NCT00102687|Secondary|Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)|The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.|6 months|Intent to treat population|||g/L||Full Range|Median
2847352|NCT00102687|Secondary|Baseline Hemoglobin Values|The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population|||g/L||Full Range|Median
2847353|NCT00102687|Primary|Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period|Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.|Day 1 (randomization) to 6 months|Intent to treat population|||participants|||Number
2847354|NCT00102687|Primary|Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.|"IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.~Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.~Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.~(continued in Population Description)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients count only once for best response within an improvement category.~(Outcome Description continued) Neutrophil response: Major->=100% increase in neutrophil count or an absolute increase of >0.5x10^9/L. Minor->=100% increase but an absolute increase of <0.5x10^9/L."|||participants|||Number
2847355|NCT00102687|Primary|Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.|"Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).~Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients without a second bone marrow assessment could not be evaluated for hematologic response.~(Outcome Description continued)SD is a failure to achieve at least a PR, but with no evidence of progression for at least 2 months."|||participants|||Number
2847356|NCT00102596|Secondary|PR and QTc Intervals Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C|||ms||Standard Error|Least Squares Mean
2847357|NCT00102596|Secondary|Heart Rate Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C|||beats per minute||Standard Error|Least Squares Mean
2847358|NCT00102596|Secondary|Blood Plasma Levels of Octanoic Acid After 64 mg/kg 1-Octanol Dose|Octanoic Acid is a metabolite of 1-octanol. Blood plasma levels of octanoic acid were measured at 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose.|5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose|All participants who received either formulation 64 mg/kg 1-octanol in Part A or B|||ng/ml||Standard Deviation|Mean
2847359|NCT00102596|Primary|Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B|Spirography mean tremor amplitudes were measured in the right hand of each participant at 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose. Then, the scores of each participant were normalized (i.e., divided by) by their baseline tremor severity scores so that all scores are expressed as a proportion of the baseline score. Therefore, 1 is the baseline tremor severity, and lower scores indicate tremor reduction.|0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose|All participants who received both formulations of 64 mg/kg 1-octanol in Part B|||normalized score on a scale||Standard Error|Mean
2847360|NCT00102531|Primary|The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.||4 to 48 weeks||||participants|||Number
2847361|NCT00102518|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score|"Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 26||||points||Standard Deviation|Mean
2847362|NCT00102518|Secondary|Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Week 26||||points||Standard Deviation|Mean
2847363|NCT00102518|Primary|Percentage of Subjects Experiencing SAEs|Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.|Baseline and Week 23|All enrolled subjects.|||percentage of participants|||Number
2847364|NCT00102440|Secondary|Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.|The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 52|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.|||percentage of subjects|||Number
2847365|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.|Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
2847366|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
2847367|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.|||number of tophi||Inter-Quartile Range|Median
2847368|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
2847369|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
2847383|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score|"Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.~Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42||||points||Standard Error|Mean
2847370|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.|||percent change from baseline||Inter-Quartile Range|Median
2847371|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||percent change from baseline||Standard Deviation|Mean
2847372|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 52.|Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||percent change from baseline||Standard Deviation|Mean
2847373|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||percent change from baseline||Standard Deviation|Mean
2847374|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
2847375|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit|Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.|Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
2847376|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.|||Percentage of subjects|||Number
2847377|NCT00102440|Primary|Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)|Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 Visits (up to 52 weeks)|Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL.|||Percentage of subjects|||Number
2847378|NCT00102063|Other Pre-specified|Patients Achieving Remission|The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.|Baseline and Day 42||||participants|||Number
2847379|NCT00102063|Other Pre-specified|Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score|"Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward.~Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome)."|Baseline and Day 42||||points||Standard Error|Mean
2847380|NCT00102063|Secondary|Change in Children's Global Assessment Scale (CGAS) Score|"Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.~Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Day 42||||points||Standard Error|Mean
2847381|NCT00102063|Secondary|Clinical Global Impression (CGI) Improvement Score|"Last observed post-baseline value in CGI improvement score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42||||points||Standard Error|Mean
2847382|NCT00102063|Secondary|Change in Clinical Global Impression (CGI) Severity Score|"Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42||||points||Standard Error|Mean
2852061|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Matched Related Patients||up to 2 years post transplant|The number of matched related patients was analyzed as per protocol.|||participants|||Number
2847384|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score|"Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.~Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42||||points||Standard Error|Mean
2847385|NCT00102063|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward.~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Day 42||||points||Standard Error|Mean
2847386|NCT00101933|Other Pre-specified|Change in Most Severe Seizures|"Seizures were recorded on daily seizure diaries. The subject recorded the number of seizures by seizure type on the seizure diary. The subject also noted at baseline, of those they had ever experienced, which seizure they considered to be most severe."|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set. In addition, the protocol prespecified that if a subject did not experience the severe seizure in the baseline phase that they would not be included in the calculation of the blinded phase median seizure frequency percentage change from baseline."|||Percentage change from baseline||Inter-Quartile Range|Median
2847387|NCT00101933|Primary|Alternative Primary Analysis: Change in Seizure Rate|A generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. With one outlier subject removed, the GEE model for this alternative analysis included treatment effect, log of the baseline seizure count, log of age, visit (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set with one additional outlier subject removed from the active group. This subject had 210 stimulation initiated seizures within 48 hours of the device being turned on and was determined to be an outlier using both a statistical and clinical rationale."|||Percentage change from baseline||Inter-Quartile Range|Median
2847388|NCT00101933|Secondary|Proportion of Treatment Failures|A treatment failure was defined in the protocol as a subject who 1) required 3 or more doses of rescue medication within 48 hours, 3 times during the blinded phase; or 2) had 3 episodes of convulsive status epilepticus during the blinded phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||participants|||Number
2847389|NCT00101933|Secondary|Percentage Change in the Maximum Length of Seizure-free Intervals|Difference between active group and control group in percentage change in the maximum length of seizure-free intervals over the entire blinded phase as compared to the entire baseline phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||Percentage change from baseline||Inter-Quartile Range|Median
2847390|NCT00101933|Secondary|Change in Percentage of Days Seizure-free|Difference between active group and control group in percentage change in seizure-free days over the entire blinded phase as compared to the entire baseline phase. The number of seizure-free days was normalized to 84-day baseline and blinded phases for each subject.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. In addition, percentage change was not calculated for subjects who had no seizure-free days during the baseline phase."|||Percentage change from baseline||Inter-Quartile Range|Median
2847391|NCT00101933|Secondary|Seizure Responder Rate|A responder is defined as a subject with greater than or equal to 50% reduction in seizures as compared with baseline.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||Number of participants|||Number
2847392|NCT00101933|Secondary|Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)|"The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP classifications were included in the calculation.~The results shown are for the entire study follow-up after device implantation."|Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years)|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects included in this analysis.|||Number of subjects experiencing SUDEP|||Number
2847393|NCT00101933|Secondary|Adverse Events Experienced With the Medtronic DBS System|"The results are for the follow-up after device implantation through Year 2 and summarized are events that occurred in greater than 5% of subjects. Only events related to the device, therapy, or surgery are included. These abbreviations were used:~General dis...=General disorders and administration site conditions~Injury, poison...=Injury, poisoning and procedural complications~Ther.=Therapeutic.~For this summary, adverse events are reported as 'MedDRA System Organ Class - adverse event'."|Through Year 2 of the long-term follow-up phase|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects, as opposed to the 109 stated in the participant flow.|||participants|||Number
2847446|NCT00101686|Primary|Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|Intent-to-Treat Population (ITT) - all subjects who were randomized, with study drug assignment designated according to initial randomization, regardless of whether subjects received any study drug or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2847394|NCT00101933|Primary|Primary Analysis: Change in Seizure Rate|A protocol-prespecified generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. The final GEE model for the primary objective evaluation included treatment effect, log of the baseline seizure count, log of age, visit (categorical), treatment-by-visit interaction (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."|||Percentage change from baseline||Inter-Quartile Range|Median
2847395|NCT00101907|Primary|Participant Incidence of Adverse Events|The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.|From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.|Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab.|||Participants|||Number
2847396|NCT00101907|Secondary|AUC0-inf|Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.|||μg*hr/mL||Standard Deviation|Mean
2847397|NCT00101907|Secondary|AUC0-24|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.|||μg*hr/mL||Standard Deviation|Mean
2847398|NCT00101907|Secondary|Cmax|The maximum observed plasma concentration after AMG 706 dosing|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set.|||ng/mL||Standard Deviation|Mean
2847399|NCT00101907|Secondary|Tmax|Time after dosing when maximum plasma concentration was observed for AMG 706|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling).|||hours||Full Range|Median
2847400|NCT00101907|Secondary|Number of Participants With an Objective Tumor Response|The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.|From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.|Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group.|||participants|||Number
2847401|NCT00101868|Secondary|Physician Time Spent to Complete the Discharge Application||averaged over 2 years of patient enrollment|||||||
2847402|NCT00101868|Secondary|Number of Emergency Department Visits|Number of participants with at least one emergency department visit within six months after discharge|within 6 months after discharge|intention to treat|||participants|||Number
2847403|NCT00101868|Secondary|Number of Outpatient Visits||within 6 months after discharge|||||||
2847404|NCT00101868|Secondary|Discharge Physician Satisfaction With Discharge Process||6 months after using discharge process|||||||
2847405|NCT00101868|Secondary|Primary Care Physician's Perception, Satisfaction||10 days after discharge|||||||
2847406|NCT00101868|Secondary|Primary Care Physician's Perception, Effectiveness||10 days after discharge|||||||
2847407|NCT00101868|Secondary|Patient's Satisfaction With Drug Information||1 week after discharge|||||||
2847408|NCT00101868|Secondary|At Least One Adverse Event Within One Month After Discharge|Number of participants with at least one adverse event within one month after discharge|1 month after discharge|intention to treat|||participants|||Number
2847409|NCT00101868|Secondary|Pharmacist's Satisfaction With Discharge Prescription||1 day after discharge|||||||
2847410|NCT00101868|Secondary|Pharmacist Needed to Clarify the Discharge Prescription||1 day after discharge|||||||
2847411|NCT00101868|Secondary|Patients' Perception of Discharge Process, Satisfaction||1 week after discharge|||||||
2847412|NCT00101868|Secondary|Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness||1 week after discharge|||||||
2847413|NCT00101868|Primary|Hospital Readmission, at Least One|Number of participants with at least one readmission within 6 months after discharge from index hospital visit|within 6 months after discharge|Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed|||participants|||Number
2847414|NCT00101816|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.||||population pk|||Number
2847415|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
2847416|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
2847417|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng∙h/mL||Standard Deviation|Mean
2847418|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng/mL||Standard Deviation|Mean
2847419|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
2847420|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
2847421|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were < lower limit of qualtitation were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng∙h/mL||Standard Deviation|Mean
2847422|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng/mL||Standard Deviation|Mean
2847447|NCT00101660|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Blood samples were collected for PK to be included in separate population PK analyses.|Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.|No study-specific PK analyses were planned for this report.|||Participants|||Number
2852156|NCT00022672|Secondary|Overall Survival at 24 Months|Overall Survival is defined as the number of days from randomization to death.|24 Months||||Months||95% Confidence Interval|Median
2847423|NCT00101816|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period|All treated subjects|||Participants|||Number
2847424|NCT00101816|Secondary|Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment|||Participants|||Number
2847425|NCT00101816|Secondary|MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations|"MaHR and MCyR in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). Criteria for MaHR are specified in Outcome Measure 2. MCyR=rate of complete cytogenetic responses + the rate of partial cytogenetic responses, as defined in Outcome Measure 5. BCR-ABL=the fused gene found in subjects with this type of CML. This table contains those mutations observed in at least 3 participants. The categories 1 IRM w/2-4-fold increase in resistance and ≥1 IRM w/≥5-fold increase in resistance refer to increase in resistance to imatinib."|baseline, at time of disease progression|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 103 of the 109 subjects (10/10 imatinib-intolerant and 93/99 imatinib-resistant). At baseline, 39 (42%) imatinib-resistant subjects and 3 imatinib-intolerant subject had imatinib-resistant mutations|||Percentage of Participants|||Number
2847426|NCT00101816|Secondary|Number of Participants Achieving Major Molecular Response (MMR)|Number of participants who achieved an MMR at any time during the treatment period. MMR was calulated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis|treated participants with or without CCyR who were assessed for major molecular response|||participants|||Number
2847427|NCT00101816|Secondary|Number of Participants With CHR or NEL, MiHR, or no Hematologic Response|Best confirmed hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for complete hematologic response (CHR) or No Evidence of Leukemia (NEL) are specified in Outcome Measure 2. Criteria for minor hematologic response (MiHR) are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment|All treated subjects|||Participants|||Number
2847428|NCT00101816|Secondary|Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response|Best confirmed cytogenetic response. Determination of cytogenetic response is based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects|||Participants|||Number
2847429|NCT00101816|Secondary|Time to MaHR and OHR|Median time from first dosing to date of OHR and/or MaHR in subjects who achieved OHR and MaHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR and MaHR|||days||95% Confidence Interval|Median
2847430|NCT00101816|Secondary|Median Duration of Overall Hematologic Response (OHR)|OHR=best confirmed response of MaHR or MiHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1. Maintaining a response was defined as no 2 consecutive records of non-response (ie, a single record of non-response between 2 assessments of response was not considered a loss of response).|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR|||months||95% Confidence Interval|Median
2847431|NCT00101816|Secondary|Median Duration of Major Hematologic Response (MaHR)|MaHR=best confirmed response of CHR or NEL. CHR=white blood cells ≤ institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤ iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement; at least 1 of the following: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved MaHR|||months||Full Range|Median
2847515|NCT00101036|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years||||percentage of responding patients|||Number
2847432|NCT00101816|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. OHR=best confirmed response of MaHR or minor HR (MiHR). MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts + promyelocytes in bone marrow and <30% blasts + promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|All treated subjects|||Participants|||Number
2847433|NCT00101686|Secondary|Overall Relative Dose Intensity of Irinotecan|Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)|End of treatment cycle|As-Treated population|||percent dose intensity||Standard Error|Mean
2847434|NCT00101686|Secondary|Dose Reduction Due to Treatment Emergent Adverse Events|Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.|Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI|As-Treated population - all subjects who received any study medication, with treatment assignments designated according to actual study treatment received.|||participants|||Number
2847435|NCT00101686|Secondary|Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.|Last Follow-Up Visit|ITT Population.|||months||95% Confidence Interval|Median
2847436|NCT00101686|Secondary|1 Year Survival: Bevacizumab With FOLFIRI, mIFL|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.|||participants|||Number
2847437|NCT00101686|Secondary|Overall Response: Bevacizumab With FOLFIRI, mIFL|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT population.|||participants|||Number
2847438|NCT00101686|Secondary|Time to Progression: Bevacizumab With FOLFIRI, mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT population.|||months||95% Confidence Interval|Median
2847439|NCT00101686|Secondary|Survival Time: Celecoxib and Placebo|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).|||months||95% Confidence Interval|Median
2847440|NCT00101686|Secondary|Overall Response: Celecoxib and Placebo|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).|||participants|||Number
2847441|NCT00101686|Secondary|Time to Progression : Celecoxib and Placebo|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).|||months||95% Confidence Interval|Median
2847442|NCT00101686|Secondary|1 Year Survival: FOLFIRI, mIFL and CapeIRI|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.|||participants|||Number
2847443|NCT00101686|Secondary|Survival Time: FOLFIRI, mIFL and CapeIRI|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population.|||months||95% Confidence Interval|Median
2847444|NCT00101686|Secondary|Overall Response: FOLFIRI, mIFL and CapeIRI|A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population.|||participants|||Number
2847445|NCT00101686|Secondary|Time to Progression: FOLFIRI, mIFL and CapeIRI|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population.|||months||95% Confidence Interval|Median
2847516|NCT00100932|Secondary|Overall Survival|Defined as the time from the start of study medication until death from any cause.|From time of start of study medication until death|||||||
2847448|NCT00101660|Secondary|Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-resistant participants who received treatment.|||Participants|||Number
2847449|NCT00101660|Secondary|Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-intolerant participants who received treatment.|||Participants|||Number
2847450|NCT00101660|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.|Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.|Number of participants with assessments at baseline and timepoint|||Participants|||Number
2847451|NCT00101660|Secondary|Number of Participants With Major Molecular Response (MMR)|MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.|Baseline to 2 years|All participants who received treatment.|||Participants|||Number
2847452|NCT00101660|Secondary|Median Time From First Dosing Until CHR|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|Population limited to responders (those achieving CHR) only|||Months||Full Range|Median
2847453|NCT00101660|Secondary|Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|12 and 24 months|Population limited to responders (those achieving CHR) only|||Percentage of participants|||Number
2847454|NCT00101660|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|All participants who received treatment.|||Participants|||Number
2847455|NCT00101660|Secondary|Median Time From First Dosing Date to Date of MCyR|MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline (within 4 weeks of Day 1) and every 12 weeks|Population is limited to responders (those who acheived MCyR) only|||Months||Full Range|Median
2847456|NCT00101660|Secondary|Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.|12 and 24 Months|Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.|||Percentage of participants|||Number
2847457|NCT00101660|Secondary|Number of Imatinib-intolerant Participants With MCyR|Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline to 2 years|All imatinib-intolerant participants who received treatment.|||Participants|||Number
2847458|NCT00101660|Primary|Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.|2 years|All imatinib-resistant participants who received treatment.|||Participants|||Number
2847459|NCT00101647|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.||||Population PK analysis|||Number
2847460|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||hours||Standard Deviation|Mean
2847461|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|A total of 29 participants had dense PK sampling on both Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable concentration-time profiles. n=the number of participants on Day 1 and Day 8 who were included in the statistical analyses of PK parameters.|||hours||Standard Deviation|Mean
2847462|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng∙h/mL||Standard Deviation|Mean
2847463|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.|||ng/mL||Standard Deviation|Mean
2847464|NCT00101647|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).||||Participants|||Number
2847465|NCT00101647|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, and functional well-being (PWB, SWB, EWB, FWB). Total score=0 to 108; higher score=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, and FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinically important change.|Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment|||Participants|||Number
2847466|NCT00101647|Secondary|MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations|Major hematologic and cytogenetic responses (MaHR and MCyR) to dasatinib in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). BCR-ABL=the fused gene found in subjects with this type of CML. Criteria for MaHR are specified in Outcome Measure 2. MCyR=combined complete cytogenetic and partial cytogenetic response rate. Complete Cytogenetic Response= 0% Ph+ Cells in Metaphase in Bone Marrow, Partial Cytogenetic Response > 0% to 35% Ph+ Cells in Metaphase in Bone Marrow.|Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 162 of the 174 subjects (12/13 imatinib-intolerant and 150/161 imatinib-resistant). At baseline, 89 (59%) imatinib-resistant subjects and 1 imatinib-intolerant subject expressed imatinib resistant mutations.|||Percentage of participants|||Number
2847478|NCT00101582|Secondary|Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks|"The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants.~Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents."|Up to 15 weeks|Full analysis set|||mg of IV morphine equivalents||Standard Deviation|Mean
2847467|NCT00101647|Secondary|Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period|Number of participants who achieved an MMR at any time during the treatment period. MMR was calculated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of Participants Analyzed=all treated subjects who were assessed for major molecular response; n=participants with or without CCyR in cohort.|||participants|||Number
2847468|NCT00101647|Secondary|Best Confirmed Hematologic Response|Number of participants with confirmed complete hematologic response (CHR) or No Evidence of Leukemia (NEL), minor hematologic response (MiHR), or no hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for CHR and NEL are specified in Outcome Measure 2; criteria for MiHR are specified in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects|||Participants|||Number
2847469|NCT00101647|Secondary|Best Cytogenetic Response|Number of participants with complete, partial, minor, minimal, or no cytogenetic response. Determination of cytogenetic response based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects|||Participants|||Number
2847470|NCT00101647|Secondary|Time to OHR|Median time (in months) from first dosing date to date of OHR. OHR=best confirmed response of MaHR or MiHR. Criteria for MaHR specified in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response = response confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population comprised of responders only|||days||Full Range|Median
2847471|NCT00101647|Secondary|Median Time in Days From First Dosing Date to Date of MaHR|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population is comprised of responders only|||Days||Full Range|Median
2847472|NCT00101647|Secondary|Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months|Percentage of participants who achieved OHR and did not progress at specified timepoints, based on the Kaplan-Meier estimate of the duration of response. OHR=best confirmed response of MaHR or MiHR. MaHR criteria in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response= confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|12 months, 24 months|Population is comprised of responders only|||Percentage of responders|||Number
2847473|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)|Percentage of participants in the Imatinib-Resistant Group who achieved MaHR and did not progress at Month 24, based on the Kaplan-Meier estimate of the duration of response. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR and NEL are specified in Outcome Measure 2.|24 months|Population comprised of responders only. NOTE: Projected duration of MaHR at 24 months in the Imatinib-Intolerant group was beyond the maximum observed time for this cohort, and therefore only the Imatinib-Resistant group is presented.|||percentage of responders|||Number
2847474|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|12 months|Population comprised of responders only.|||percentage of responders|||Number
2847475|NCT00101647|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects|||participants|||Number
2847476|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy.|During the 7 weeks of radiotherapy|Full analysis set|||participants|||Number
2847477|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment|Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason.|During the 7 weeks of chemotherapy treatment|Full analysis set|||participants|||Number
2847479|NCT00101582|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments."|Assessed twice a week for up to 15 weeks.|"The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either:~At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or~70% or greater overall compliance for MTS until withdrawal/Week 8."|||units on a scale||Standard Deviation|Mean
2847480|NCT00101582|Secondary|Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)|The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.|Month 4|Full Analysis Set|||participants|||Number
2847481|NCT00101582|Secondary|Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis|"Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure.~Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM."|Up to 15 weeks|Full analysis set|||days||Inter-Quartile Range|Median
2847482|NCT00101582|Secondary|Duration of Severe (WHO Grade 3 or 4) Oral Mucositis|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to 15 weeks|Full analysis set|||days||Inter-Quartile Range|Median
2847483|NCT00101582|Primary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Week 15|The Full Analysis Set included all randomized participants.|||participants|||Number
2847484|NCT00101452|Primary|Hamilton Rating Scale for Depression (HAM-D)|The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.|baseline and 24 weeks|Based on having at least one post-baseline visit.|||units on a scale||Standard Deviation|Mean
2847485|NCT00101439|Secondary|Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein subfractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.|||mg/dL||Full Range|Geometric Mean
2847486|NCT00101439|Primary|Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein fractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.|||mg/dL||Full Range|Geometric Mean
2847487|NCT00101413|Secondary|Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)|HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.|From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.|||scores on a scale||Standard Deviation|Mean
2847513|NCT00101036|Secondary|Progression-free Survival|Estimated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|Up to 5 years||||Months||95% Confidence Interval|Median
2847488|NCT00101413|Secondary|Percentage of Subjects With Stable Disease (SD)|Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.|||Percentage of participants|||Number
2847489|NCT00101413|Secondary|Overall Survival|"Overall survival was calculated from the date of the first treatment until death of the subject.~Evaluation by Kaplan-Meier methodology, descriptive analysis."|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.|||days||95% Confidence Interval|Median
2847490|NCT00101413|Secondary|Duration of Stable Disease|Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.|||days||95% Confidence Interval|Median
2847491|NCT00101413|Primary|Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)|CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- >=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- >=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- >clinically meaningful cancer-related deterioration as judged by the investigator.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.|||percentage of participants|||Number
2847492|NCT00101400|Secondary|Number of Subjects With Stable Disease up to Cycle 4|Number of subjects who had not responded to treatment but had stable disease up to cycle 4.|Until 30 days after termination of active therapy|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.|||participants|||Number
2847493|NCT00101400|Secondary|Survival Time|After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).|Start of treatment to death|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.|||days||95% Confidence Interval|Median
2847494|NCT00101400|Secondary|Overall Response Duration|Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.|Time from PR or CR to progression|1 subject out of 54 achieved PR.|||days|||Number
2847495|NCT00101400|Secondary|Time to Objective Response|Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.|Until objective response occurs|1 subject out of 54 achieved PR.|||days|||Number
2847496|NCT00101400|Secondary|Time to Progression|Time from start of treatment until progression was first documented.|Until progression occurs|Of the intent to treat population, 4 subjects died before assessment of progression; for 1 subject the progression date not available; and 1 subject was lost to follow-up.|||days||95% Confidence Interval|Median
2847497|NCT00101400|Primary|Number of Subjects With Response (Complete or Partial)|Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.|Until 30 days after termination of active therapy|Intent to treat population consisted of subjects who received at least 1 dose of sorafenib.|||participants|||Number
2847498|NCT00101361|Primary|A Healed Pressure Ulcer|Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.|healing was measured from randomization to full healing or 24 weeks, whichever occured first.||||participants|||Number
2847499|NCT00101283|Secondary|Progression-Free Survival|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.|||Months||95% Confidence Interval|Median
2847500|NCT00101283|Secondary|Overall Survival|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.|||Months||95% Confidence Interval|Median
2847514|NCT00101036|Secondary|Overall Survival|Estimated by the Kaplan-Meier method.|Up to 5 years||||Months||95% Confidence Interval|Median
2847501|NCT00101283|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.|Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.|||eligible, treated participants|||Number
2847502|NCT00101192|Secondary|Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment||up to 5 years from study entry|||||||
2847503|NCT00101192|Primary|Tumor Response|"Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria:~Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.~Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease: any condition not meeting the above criteria.~Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|up to 6 months from study entry|Eligible and evaluable participants|||participants|||Number
2847504|NCT00101166|Secondary|Overall Survival (OS) in Months|Average overall survival time in months.|Average of 14 months|All 28 participants who were vaccinated on this study.|||months||95% Confidence Interval|Mean
2847505|NCT00101166|Secondary|Time to Progression (TTP) in Months|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Average of 14 months|All 28 participants who were vaccinated on this study.|||months||95% Confidence Interval|Mean
2847506|NCT00101166|Secondary|Number of Participants With Stable Disease|Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Average of 14 months|All 28 participants who were vaccinated on this study.|||participants|||Number
2847507|NCT00101166|Primary|Number of Participants With Partial Response|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Average of 14 months|All 28 participants who were vaccinated on this study.|||participants|||Number
2847508|NCT00101166|Secondary|Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment|Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).|Average of 14 months|All 28 participants who were vaccinated on this study.|||participants|||Number
2847509|NCT00101101|Secondary|Median Event Free Survival (EFS)|Vaccine Response - EFS among participants who received vaccination. Event free survival (EFS) was calculated from date of enrollment until progression or death from any cause. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|18 months|Participants who received at least one vaccine injection.|||months||95% Confidence Interval|Median
2847510|NCT00101101|Secondary|Occurrence of Related Serious Adverse Events (SAEs)|Patients were monitored for toxicity every 4 weeks in clinic throughout the 4-month vaccination phase. This included clinical and laboratory evaluation (CBC, blood urea nitrogen (BUN), creatinine, electrolytes, liver function test (LFT), and serum LDH). Toxicity was defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE-3) Version 3.0 (www.ctep.cancer.gov). Grade 3 or higher SAEs attributed to vaccination: Toxicity was assessed in the 23 patients who received at least one vaccine injection.|4 months per participant|Participants who received at least one vaccine injection.|||participants|||Number
2847511|NCT00101101|Primary|Rate of Immunological Response to Vaccination|"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.~DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.~3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist."|4 months per participant|Participants who received at least one vaccine injection.|||participants|||Number
2847512|NCT00101036|Secondary|Disease Control Rate.|"The mathematical sum of percentages of complete response, partial response and stable disease.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions"|Up to 5 years||||percentage of participants|||Number
2847517|NCT00100932|Secondary|Progression Free Survival|Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.|From start of study medication until progressive disease or death|Intent to Treat/Safety Population|||Days||Full Range|Median
2847518|NCT00100932|Secondary|Duration of Response|Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.|From time of CR or PR until recurrence or progressive disease|Intent to Treat/Safety Population|||Days||Full Range|Median
2847519|NCT00100932|Primary|Overall Objective Response Rate (ORR)|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|From start of treatment until disease progression or recurrence|Intent to Treat/Safety Population|||percentage of participants|||Number
2847520|NCT00100841|Primary|Progression Free Survival Rate||From randomization to the first documented disease progression||||months||95% Confidence Interval|Median
2847521|NCT00100841|Primary|Severe Adverse Event (SAE) Rate|The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation|The duration of the study|66 patients treated with cetuximab|||participants|||Number
2847522|NCT00100828|Primary|Response Rate|To determine the response rate of this regimen of irinotecan in patients with metastatic MTC|Every 2 cycles|Study was closed to enrollment due to low accrual. Data was not collected for this outcome measure.||||||
2847523|NCT00100815|Secondary|Overall Survival||every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients|||months||90% Confidence Interval|Median
2847524|NCT00100815|Secondary|Clinical Response|Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.|Pre-treatment and every 6 weeks from treatment.|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2847525|NCT00100815|Secondary|Percentage of Participants With Improved Quality of Life|Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.|assessed at baseline then weekly for 3 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2847526|NCT00100815|Secondary|Percentage of Participants With Grades 3-5 Treatment Related Toxicities|Grade 3, 4 or 5 toxicity rate|Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2847527|NCT00100815|Primary|Progression-free Survival|Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2847528|NCT00100802|Primary|Occurrence of Death Attributable to Complications of Protocol Therapy|Number of deaths due to complications of protocol therapy.|While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy|106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.|||patients|||Number
2847529|NCT00100802|Primary|One Year Overall Survival|Estimated one year survival using the Kaplan-Meier methodology.|One year|Population is based on 106 eligible patients out of 118 patients enrolled.|||Estimated probability||95% Confidence Interval|Number
2847530|NCT00100789|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
2847531|NCT00100789|Secondary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|9 weeks - 3 years|All eligible patients with measurable disease who started treatment were included in response measures.|||participants|||Number
2847532|NCT00100789|Primary|Overall Survival|Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.|||months||95% Confidence Interval|Median
2847533|NCT00100789|Secondary|Progression-free Survival|Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.|||months||95% Confidence Interval|Median
2847534|NCT00100698|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure|18 months||||mm Hg||Standard Error|Mean
2847535|NCT00100698|Secondary|Change in 2-hour Glucose|Change in 2-hour glucose|18 months||||mg/dL||Standard Error|Mean
2847541|NCT00100698|Secondary|Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months|Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.|18 months||||units on a scale||Standard Error|Mean
2847542|NCT00100698|Secondary|Change in Lean Body Mass|change in lean body mass|18 months||||kilograms||Standard Error|Mean
2847543|NCT00100698|Secondary|Change in Logarithm HIV Viral Load|Change in logarithm base 10 HIV viral load|18 months||||log base 10 copies of RNA/milliliter||Standard Error|Mean
2847544|NCT00100698|Secondary|Change in CD4 Cells|Change in CD4 cells|18 months||||cells/microliter||Standard Error|Mean
2847545|NCT00100698|Secondary|Change in Subcutaneous Adipose Tissue|Change in subcutaneous adipose tissue|18 months||||centimeters squared||Standard Error|Mean
2847546|NCT00100698|Secondary|Change in Triglycerides|Change in triglycerides|18 months||||mg/dL||Inter-Quartile Range|Median
2847547|NCT00100698|Secondary|Change in Trunk to Extremity Ratio|change in trunk to extremity ratio|18 months||||kilogram per kilogram||Standard Error|Mean
2847548|NCT00100698|Secondary|Change in Fasting Glucose|change in fasting glucose|18 months||||mg/dL||Standard Error|Mean
2847549|NCT00100698|Secondary|Change in Trunk Fat||18 months||||kilograms||Standard Error|Mean
2847550|NCT00100698|Secondary|Change in Insulin-like Growth Factor-I From Baseline to 18 Months|Change in insulin-like growth factor-1|18 months||||nanograms/milliliter||Standard Error|Mean
2847551|NCT00100698|Primary|Change in Visceral Adipose Tissue Area From Baseline to 18 Months|change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan|18 months||||centimeters squared||Standard Error|Mean
2847552|NCT00100659|Secondary|Adverse Events|Influenza-like, headache, and gastrointestinal symptoms|At any time up to 72 weeks||||Participants|||Count of Participants
2847553|NCT00100659|Primary|Sustained Viral Response (SVR)|SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma|at least 24 weeks after stopping treatment.||||participants|||Number
2847554|NCT00100230|Other Pre-specified|Loss of Peripheral Visual Fields|Hypothesis: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of peripheral visual fields in this 4-year trial.|4 years|Only participants completing at least one year of trial|||decibels (dB)||Standard Error|Mean
2847555|NCT00100230|Secondary|Rate of LOSS of Rod Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of rod electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)|||change in amplitude, log microvolts/year||Standard Error|Mean
2847556|NCT00100230|Primary|Rate of LOSS of 31 Hertz Cone Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of 31 hertz cone electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)|||log microvolts/year||Standard Error|Mean
2847557|NCT00100178|Primary|Mean Stimulated C-peptide Area Under the Curve|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years|Participants who completed a 4-hour mixed meal glucose tolerance test at the two-year visit were included in the analysis|||pmol/ml||95% Confidence Interval|Geometric Mean
2847558|NCT00100165|Secondary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms measures the measure negative symptoms in schizophrenia by measuring the domains of anhedonia, alogia, avolition and anhedonia in schizophrenia on a scale from 1 to 20 that sums the global scores of all 4 domains, each of which are rated on a scale of 1-5. Higher scores indicate greater severity of negative symptoms|1 month|change in the total scale score from baseline measure with administration of either drug or placebo|||units on a scale change from baseline||Standard Deviation|Mean
2847559|NCT00100165|Primary|Neurocognitive Performance|The measurement of neurocognitive performance on 6 domains, speed of processing, attention/vigilance, working memory, verbal learning, visual learning and reasoning/problem solving. Each domain is compared to a normative sample of schizophrenia subjects and the performance is determined and compared by a T-Test to the subjects baseline performance to determine the effect of drug or placebo. The scale is the National Institute of Mental Health Measurement and Treatment Research to Improve Cognition in Schizophrenia Neurocognitive Consensus Combined Battery, range 0-100. A higher score indicates better performance.|1 month|change from baseline in cognitive performance as measured by a t-test at 4 weeks after taking the drug or placebo|||t-score change from baseline||Standard Deviation|Mean
2847560|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With LAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847561|NCT00100048|Secondary|Change From Baseline in CD4 (T-helper) Cell Count at Week 240|Change in number of CD4 cells/mm^3 from baseline to Week 240.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||cells/mm^3||95% Confidence Interval|Mean
2847562|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||Log10Copies/mL||95% Confidence Interval|Mean
2847577|NCT00100048|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 Weeks|"The analysis population is based upon the All~Patients As Treated (APaT) approach."|||participants|||Number
2847563|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||Participants|||Number
2847564|NCT00100048|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.|||cells/mm3||95% Confidence Interval|Mean
2847565|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.|||copies/mL||95% Confidence Interval|Mean
2847566|NCT00100048|Secondary|Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96||96 Weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.|||participants|||Number
2847567|NCT00100048|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||cells/mm3||95% Confidence Interval|Mean
2847568|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)|Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||copies/mL||95% Confidence Interval|Mean
2847569|NCT00100048|Primary|Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.|||Participants|||Number
2847570|NCT00100048|Primary|Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)|"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose."|Week 240|The analysis population was based upon the All Patients As Treated (APaT) approach.|||Participants|||Number
2847571|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)||Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||participants|||Number
2847572|NCT00100048|Primary|Number of Patients With Serious CAEs and Non-serious CAEs at Week 144|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product~An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product"|144 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847573|NCT00100048|Primary|Number of Patients With Serious CAEs (Cohort I and II Combined)|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847574|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847575|NCT00100048|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847576|NCT00100048|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847578|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With CAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847579|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach|||participants|||Number
2847580|NCT00100048|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847581|NCT00100048|Other Pre-specified|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48||48 weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||participants|||Number
2847582|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847583|NCT00100048|Primary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)||Week 24|"The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.~All patients who took study medication and had HIV RNA tests performed were included in the analysis."|||participants|||Number
2847584|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.~Serious CAEs are any AEs occurring at any dose that; Results~in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or~prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an~overdose."|10 days|The analysis population is based upon the All Patients As Treated (APaT) approach.|||participants|||Number
2847585|NCT00100048|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)|Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)|Baseline and Day 10|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.|||copies/mL||95% Confidence Interval|Mean
2847586|NCT00099983|Primary|Change in CAPS Score From Baseline to Week 24|The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.|24 Weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2847587|NCT00099632|Secondary|Number of Participants Who Discontinued Study Treatment Prematurely|participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.|From first day of study treatment to last day of study treatment (up to 21 days)||||participants|||Number
2847588|NCT00099632|Secondary|Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12|"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death"|From first day of study treatment to week 12||||participants|||Number
2847589|NCT00099632|Secondary|Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment||||participants|||Number
2847590|NCT00099632|Secondary|Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment||||participants|||Number
2847591|NCT00099632|Primary|Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping|"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis."|2 and 6 weeks after completion of treatment|412 women with primary endpoint results available|||participants|||Number
2847592|NCT00099437|Secondary|Overall Survival (OS) - Follow-up|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)|Median time (in months) from randomisation until death (from any cause),up to 80 months|All randomised patients|||months||Full Range|Median
2847625|NCT00099021|Secondary|Patients' Clinical Response|Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= >or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= >or= 25% increase in sum of lesions|Week 16 (4 weeks post dose)||||Participants|||Number
2847593|NCT00099437|Secondary|Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study|Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.|TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)||||Scores on a scale||Standard Deviation|Mean
2847594|NCT00099437|Secondary|Overall Survival (OS)|Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)|All patients with measurable disease at baseline.|||Time (in months)||Full Range|Median
2847595|NCT00099437|Secondary|Duration of Clinical Benefit (DoCB)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||Time (in months)||Full Range|Median
2847596|NCT00099437|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||Time (in months)||Full Range|Median
2847597|NCT00099437|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.|Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||Percentage of patients|||Number
2847598|NCT00099437|Secondary|Objective Response Rate (ORR)|Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|All patients with measurable disease at baseline.|||Percentage of patients|||Number
2847599|NCT00099437|Primary|Time to Progression (TTP)|Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).|RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)||||months||Full Range|Median
2847600|NCT00099359|Secondary|NVP Pharmacokinetics|Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.|14 days||||ng/mL||Full Range|Median
2847601|NCT00099359|Secondary|Risk Factors for Perinatal HIV-1 Transmission|Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.|through age 3 months|All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model.|||participants|||Number
2847602|NCT00099359|Secondary|3TC and NFV Pharmacokinetics|Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.|through age 14 days|This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours.|||ug*h/mL||Full Range|Median
2847603|NCT00099359|Secondary|Clinical Covariates of HIV-1 Infection|Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.|through age 3 months|||||||
2847604|NCT00099359|Secondary|Participant Deaths||through age 6 months||||participants|||Number
2847605|NCT00099359|Secondary|Infant HIV-1 Infection Status|In utero HIV-1 infection rate|birth||||participants|||Number
2847606|NCT00099359|Primary|Participants With Serious Adverse Events|Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders|through age 6 months.||||participants|||Number
2847607|NCT00099359|Primary|Infant HIV Infection Status|Intrapartum HIV infection at 3 Months|3 months|All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis.|||participants|||Number
2847608|NCT00099268|Secondary|Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)|The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 156|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
2847701|NCT00098371|Primary|Response Duration|Response evaluation criteria based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response. Descriptive statistics will be computed (median, range, mean, standard deviation, minimum, and maximum) on response duration.|Up to 8 months|Duration of response was not collected for patients.||||||
2847609|NCT00099268|Secondary|Occurrence of Dyskinesia|"Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered yes to the following question: In your opinion, does this patient have dyskinesia?"|Baseline to Week 208|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded.|||Participants|||Number
2847610|NCT00099268|Secondary|Time to First Occurrence of Wearing-off|Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.|Baseline to end of study (134-208 weeks of treatment)|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||Weeks||Standard Error|Mean
2847611|NCT00099268|Secondary|Occurrence of Wearing-off|Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.|Baseline to Week 134|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded.|||Participants|||Number
2847612|NCT00099268|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)|The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline, Week 6 and Week 130|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
2847613|NCT00099268|Primary|Time to First Occurrence of Dyskinesia|"Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered yes to the following question: In your opinion, does this patient have dyskinesia? Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study."|Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.|||weeks||95% Confidence Interval|Number
2847614|NCT00099047|Primary|Changes in M-protein Levels|For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.|Baseline and 6 months|One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.|||g/dL||Standard Deviation|Median
2847615|NCT00099021|Other Pre-specified|Nf Kappa B p65|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847616|NCT00099021|Other Pre-specified|Apotosis (Cell Death)|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847617|NCT00099021|Other Pre-specified|Ki 67 Labeling Index|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847618|NCT00099021|Other Pre-specified|Piogliotazone Gamma Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847619|NCT00099021|Other Pre-specified|Cyclooxygenase-2 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847620|NCT00099021|Other Pre-specified|Cyclin D1 and p21 Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847621|NCT00099021|Other Pre-specified|Involucrin and Transglutaminase Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847622|NCT00099021|Other Pre-specified|Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847623|NCT00099021|Other Pre-specified|Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum|Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment|||||||
2847624|NCT00099021|Secondary|Patients' Histological (Tissue) Response|Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = >or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = >or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma.|Week 16 (4 weeks post dose)||||Participants|||Number
2847626|NCT00099021|Primary|Patients' Overall Response|"Overall Response= reviewing both the clinical and histological responses and assigning the worst category.~Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD"|Week 16 (4 weeks post dose)||||Participants|||Number
2847627|NCT00098956|Secondary|Adverse Events, Graded Using the CTCAE Version 3.0||Up to 5 years||||types of grade 3 / 4 toxicities reported|||Number
2847628|NCT00098956|Secondary|Overall Survival||From the date of enrollment to death or last contact, assessed up to 5 years|Data were not collected||||||
2847629|NCT00098956|Secondary|Progression-free Survival||From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years|Data were not collected||||||
2847630|NCT00098956|Secondary|Duration of Responses||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|Data were not collected||||||
2847631|NCT00098956|Secondary|Stable Disease Rate Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 5 years||||participants|||Number
2847632|NCT00098956|Primary|Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 5 years||||participants|||Number
2847633|NCT00098865|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed after treatment discontinued every 3 months up to 2 years.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2847634|NCT00098865|Secondary|Overall Response|"Overall response is the best response during 6 months of therapy measured by radiographic response.~Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive).~Partial Response (PR): > 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a < 50% reduction in tumor size.~Stable Disease (SD): < 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): > 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology"|Assessed every 8 weeks while on treatment and every 3 months for one year off-study||||participants|||Number
2847635|NCT00098865|Primary|Therapy Completion Rate|Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.|6 months|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
2847636|NCT00098839|Secondary|Pharmacokinetics|Mean trough serum concentration measured before final dose of epratuzumab.|Up to day 36|Pharmacokinetics (PK) were added to the protocol with amendment 5A for the twice weekly dosing schedule of Epratuzumab. Hence, PK studies were limited to evaluable patients on this Arm only.|||ug/mL||Standard Deviation|Mean
2847637|NCT00098839|Primary|Rate of Minimal Residual Disease (MRD) < 0.01%|Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients who had MRD measured at the end of Block 1. There were 2 ineligible patients for once weekly arm and 13 patients where MRD was not measured at the end of block 1 re-induction therapy. There were 16 patients for twice weekly arm where MRD was not measured at the end of block 1 re-induction therapy.|||Proportion of participants|||Number
2847638|NCT00098839|Primary|Event-free Survival Rate|Proportion of patients who were event free at 4 months|At 4 months after enrollment|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.|||Proportion of participants|||Number
2847639|NCT00098839|Primary|Remission Re-induction (CR2) Rate|The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.|||proportion of participants|||Number
2847640|NCT00098813|Primary|Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria||From start of treatment to 8 weeks||||participants|||Number
2847641|NCT00098787|Secondary|Overall Survival (OS)|Overall survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to death. Patients alive at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients|||months||95% Confidence Interval|Median
2848010|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 12|Laboratory hematology hematocrit|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2847642|NCT00098787|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients|||months||95% Confidence Interval|Median
2847643|NCT00098787|Primary|Objective Response Rate|Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.|Eligible and treated patients|||proportion||90% Confidence Interval|Number
2847644|NCT00098774|Secondary|4 Year Overall Survival Rate|Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.|4 years||||percentage of participants||95% Confidence Interval|Number
2847645|NCT00098774|Secondary|Change From Baseline in Mini-Mental Status Evaluation at 4 Months|Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.|Baseline & month 4|Only 14 participants had both baseline and 4 month MMSE evaluations reported.|||units on a scale||Full Range|Median
2847646|NCT00098774|Secondary|4 Year Progression Free Rate|"Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method.~Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body"|4 years||||percentage of participants||95% Confidence Interval|Number
2847647|NCT00098774|Primary|Complete Response Rate After Remission Induction|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|4 months||||percentage of participants||95% Confidence Interval|Number
2847648|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per CDC HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 48|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.|||participants|||Number
2847649|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 24|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.|||participants|||Number
2847650|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0, 1, 2, or ≥3 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week48|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.|||particpants|||Number
2847651|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0-1, 2-4, >4 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week 24|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.|||participants|||Number
2847652|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 48|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).|||participants|||Number
2847653|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 24|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).|||participants|||Number
2847654|NCT00098748|Secondary|Number of Subjects Per Genotype and Phenotype at Baseline and at Time of Failure|Number of subjects per genotype and phenotype (tests for presence of non CCR5-tropic HIV-1 and for resistance to reverse transcriptase, protease, and fusion inhibitors) at baseline and at time of failure through Week 48 visit. Sensitivity to drug categorized as 0-1, 2-4, >4; scores defined as 0=resistance, 1=sensitive or susceptible with higher number indicating greater sensitivity or susceptibility.|Baseline through Week 48|FAS-as treated dual-tropic subjects. Genotype and phenotype at screening and at time of failure were not summarized as planned.|||participants|||Number
2847655|NCT00098748|Secondary|Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA|Change from baseline of TAD in log10 HIV-1 RNA viral load calculated as [AUC of HIV-1 RNA viral load (log10 copies/mL) / time period] - Baseline HIV-1 RNA viral load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Discontinuations prior to time point of analysis imputed as 0.|||log10 copies/mL||Standard Error|Mean
2847656|NCT00098748|Secondary|Time (50% Quartile Point Estimate) to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of test drug [perm DC]; lost to follow-up [LTFU]; new anti-retroviral drug added (except background drug change to drug of same class); or on open label for early non-response or rebound). Failure: at Time 0 if level not <400 copies/mL (2 consecutive visits) before event(s) or last available visit; at time of earliest event if level <400 copies/mL (on 2 consecutive visits); failure if level ≥400 copies/mL (2 consecutive visits) or 1 visit ≥400 copies/mL followed by perm DC or LTFU.|Day 1 through Week 24 and through Week 48|FAS - as treated dual-tropic subjects; (n)=number of subjects with virologic failure at observation for maraviroc QD, maraviroc BID, and placebo, respectively; Week 48 result values (0.00)=virologic failure at Day 0.|||days||95% Confidence Interval|Median
2847657|NCT00098748|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in CD8 cell count (measured as cells/µL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.|||cells/µL||Standard Error|Mean
2847658|NCT00098748|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in CD4 cell count (measured as cells per microliter [cells/µL]). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.|||cells/µL||Standard Error|Mean
2847659|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL||Baseline, Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
2847660|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 1.0 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
2847661|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 0.5 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
2847662|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL||Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).|||participants|||Number
2847663|NCT00098748|Primary|Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/mL]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|Full Analysis Set (FAS)-as treated: all randomized subjects classified as dual-tropic by phenotype assay; received at least 1 dose of study treatment. Missing values: discontinuations (DC) imputed as baseline value (change from baseline=0); missing data imputed as Last Observation Carried Forward (LOCF).|||log10 copies/mL||Standard Error|Mean
2847664|NCT00098722|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.|||log10copies/mL||Standard Deviation|Mean
2847665|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
2847666|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
2847667|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
2847668|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
2847669|NCT00098722|Secondary|Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.|||participants|||Number
2847670|NCT00098722|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
2847671|NCT00098722|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.|||days||95% Confidence Interval|Median
2847672|NCT00098722|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/μL||Standard Error|Least Squares Mean
2847673|NCT00098722|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/μL||Standard Error|Least Squares Mean
2847674|NCT00098722|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||cells per microliter (cells/μL)||Standard Deviation|Mean
2847675|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
2848011|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 6|Laboratory hematology hematocrit|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2847676|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
2847677|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
2847678|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
2847679|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as LOCF for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
2847680|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
2847681|NCT00098722|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.|||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
2847682|NCT00098670|Secondary|Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|6 weeks beginning at study week 36|58 participants were treatment with Alemtuzumab.|||participants|||Number
2847683|NCT00098670|Secondary|2 Year Survival|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration||||percentage of participants|||Number
2847684|NCT00098670|Secondary|2 Year Progression Free Survival|Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method.|2 years from registration||||percentage of participants|||Number
2847685|NCT00098670|Secondary|Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab|"Response, as defined by the National Cancer Institute Working Group (NCIWG):~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Up to 9 months||||participants|||Number
2847686|NCT00098670|Primary|Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG):~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|Duration of treatment (up to 13.5 months)|58 participants were treated with Alemtuzumab.|||participants|||Number
2847687|NCT00098475|Secondary|Proportion of Patients With Objective Response (First Phase, Step 2)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 2|Only eligible patients were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2847713|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
2847688|NCT00098475|Primary|Proportion of Patients With Objective Response (First Phase, Step 1)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 1|Only eligible patients were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2847689|NCT00098371|Secondary|Comparison of Clinical Response and Tumor Lysis in Vivo With Drug-induced Apoptosis and Mitochondrial Perturbation in Vitro as Assessed by Flow Cytometry|CLL cells will be incubated with control or flavopiridol (1 or 2.8 microMolar) for 4-hours followed by a 20 hours in media with 10% heat-inactivated human serum. Assessment of apoptosis following exposure of human CLL cells will be performed using annexin/PI flow cytometry. Patient samples with greater than 50% live cells (annexin-/PI-) following exposure to 2.8 microMolar flavopiridol will be considered to have insensitive disease. Patients whose CLL cells have less than 50% live cells at 1 microMolar will be considered to have highly sensitive disease.|At baseline|A subset of patients who had sufficient material were analyzed according to response only.|||percentage of priming cells||Standard Deviation|Mean
2847690|NCT00098371|Secondary|Levels of Mcl-1 mRNA, Mcl-1 Protein, HIF-1alpha Protein, HIF-1alpha mRNA, NF-kappaB Activation, Total IkB, IkB Phosphorylation, GSK-beta Activity, and IL-6 Target Genes (i.e., STAT3)|Assessed by real time RT-PCR (mcl-1, HIF-1alpha), immunoblot analysis (mcl-1, HIF-1alpha, I-kappaB, I-kappaB phosphorylation, targets of IL-6), and electrophoretic mobility shift analysis (NF-kappaB activation)|At baseline, 4.5 hours (end of continuous infusion), 8 hours, and approximately 24 hours following initiation of therapy|Data was not collected and analyzed for this outcome||||||
2847691|NCT00098371|Secondary|Correlation of Adverse Prognostic Factors With Response to Flavopiridol Treatment as Assessed by Interphase Cytogenetics, VH Mutational Status, ZAP-70 Protein Expression, CD38, and p53|overall response rates (CR+PR)|up to 8 months|Data were not collected and analyzed for VH mutational status, ZAP-70 protein expression, CD38, and p53|||percentage of patients in each subgroup|||Number
2847692|NCT00098371|Secondary|Comparison of CLL Cell Samples Taken at Registration/Diagnosis to CLL Cell Samples Taken at Time of Relapse|Samples will be examined for ex vivo sensitivity to flavopiridol, expression of select anti-apoptosis proteins, BCRP mRNA and protein expression, difference in gene expression by cDNA microarray and potentially by epigenetic arrays. Comparisons will be used to evaluate mechanisms of acquired flavopiridol resistance.|At baseline and at time of relapse or when patient goes off therapy due to disease progression|Data for this outcome as not collected and analyzed||||||
2847693|NCT00098371|Secondary|Serial Levels of IL-6 as Assessed by Blood Plasma|IL-6 measures were adjusted for baseline values|4.5 hours, 8 hours, 12 hours, and 24 hours following the initiation of therapy during day 1 of course 1|IL-6 expression analysis was available for only day 1 and not day 8.|||pg/ml||95% Confidence Interval|Mean
2847694|NCT00098371|Secondary|PK as Assessed by Levels of Both Flavopiridol and Metabolites of Flavopiridol in Urine Samples|urine samples were collected in some patients during the first 24 hours after the start of the infusion on cycle 1, day 1 to isolate metabolites of flavopiridol to be used as internal standard for plasma metabolite quantification experiments.|Urine collected at 4 separate times in some patients during the first 24 hours after start of infusion on day 1 of course 1.|Data for this PK analysis was not collected and analyzed.||||||
2847695|NCT00098371|Secondary|PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol|During treatment day 1 and day 8 of course 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.|||μM||Standard Deviation|Mean
2847696|NCT00098371|Secondary|Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol using Area Under the Curve (AUC)|During treatment day 1 and day 8 of cycle 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.|||μM*hr||Standard Deviation|Mean
2847697|NCT00098371|Primary|Toxicity|Toxicity determination based on NCI Common Toxicity Criteria version 3 and modified NCI Common toxicity guidelines for evaluating hematologic toxicity in leukemia.|Measurement prior to each infusion, at end of therapy, 2 months post-completion and post-treatment follow-up every 3 months for two years.|Grade 3 to 4 infections requiring IV antibiotics and were generally related to upper or lower respiratory infections or infections of indwelling central venous catheters.|||percentage of patients|||Number
2847698|NCT00098371|Primary|Overall Survival|Overall survival data will be reported on a 3-month basis for 5 years|Up to 5 years||||months||95% Confidence Interval|Median
2847699|NCT00098371|Primary|Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT were censored at the time of transplantation.|Up to 5 years||||months||95% Confidence Interval|Median
2847700|NCT00098371|Primary|Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT (Stem cell transplantation) were censored at the time of transplantation.|Up to 5 years||||months||95% Confidence Interval|Median
2848017|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2847702|NCT00098371|Primary|Overall Response Rate (CR + PR)|CR requires all of the following: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. Patients with CR after induction but wih treatment-related persistent cytopenia is a PR. PR requires a > 50% decrease in peripheral lymphocyte count from pretreatment value, > 50% reduction in lymphadenopathy, and/or > 50% reduction in splenomegaly/hepatomegaly. These patients must have one of the following: polymorphonuclear leukocytes > 1,500/μL , platelets > 100,000/μL, hemoglobin > 11.0 g/dl (untransfused) or any with 50% improvement from pretreatment value.|Up to 8 months|Schedule was amended (cycle length) from 42 to 28 days, reduction in the number of doses per cycle from 4 to 3 and administration of prophylactic dexamethasone 20 mg IV on each treatment day.|||percent of patients||95% Confidence Interval|Number
2847703|NCT00098371|Primary|Complete Response (CR) Rate|CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent.|Up to 8 months|Patients were assessed for clinical response after two, four and six cycles.|||percent of patients|||Number
2847704|NCT00098345|Secondary|World Health Organisation (WHO) Performance Status|Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)|Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.||||Participants|||Number
2847705|NCT00098345|Secondary|Symptomatic Response|Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.|Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.||||Participants|||Number
2847706|NCT00098345|Secondary|Biochemical Response Calcitonin (CTN)|A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).|Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation||||Participants|||Number
2847707|NCT00098345|Secondary|Disease Control Rate|Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.||||Participants|||Number
2847708|NCT00098345|Secondary|Duration of Objective Response|Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.||||days||95% Confidence Interval|Median
2847709|NCT00098345|Secondary|Progression Free Survival|Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|Upper limit is a censored value|||months||Full Range|Median
2847710|NCT00098345|Primary|Objective Response Rate|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.||||Participants|||Number
2847711|NCT00098306|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm at particular time-point. LOCF was used to impute missing values.|||log10copies/mL||Standard Deviation|Mean
2847712|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
2847757|NCT00098254|Secondary|Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml|Difference in placental derived growth factor (PLGF) between day 28 and day 0 of < 11 pg/ml vs. > 12 pg/ml.|17 months||||months||95% Confidence Interval|Median
2847714|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
2847715|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.|||participants|||Number
2847716|NCT00098306|Secondary|Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.|||participants|||Number
2847717|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
2847718|NCT00098306|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
2847719|NCT00098306|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.|||days||95% Confidence Interval|Median
2847720|NCT00098306|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/µL||Standard Error|Least Squares Mean
2847721|NCT00098306|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/µL||Standard Error|Least Squares Mean
2847722|NCT00098306|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||cells per microliter (cells/µL)||Standard Deviation|Mean
2847723|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
2847724|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
2847725|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."|||percentage of participants|||Number
2847726|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."|||percentage of participants|||Number
2847727|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.|||log10 copies/mL||Standard Error|Least Squares Mean
2847728|NCT00098306|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.|||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
2847729|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 96|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
2847730|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 48|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
2847731|NCT00098293|Other Pre-specified|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
2847732|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Baseline, Week 48, Week 96|Data not analyzed because of insufficient diversity amongst participants with respect to baseline resistance due to the study entry criteria regarding baseline resistance.||||||
2847733|NCT00098293|Secondary|Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).|Screening, time of failure through Week 48, Week 96|FAS population; n=participants with treatment failure at specified time points for each arm group respectively. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination focus shifted from efficacy, safety to only safety as reflected in abbreviated set of efficacy noted in amended planned analysis.|||participants|||Number
2847734|NCT00098293|Secondary|Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.|||participants|||Number
2847758|NCT00098254|Secondary|Percent of Participants With Genotyping of CYP3A4/5 and 5 Polymorphisms|All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.|58 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||Percent of participants|||Number
2847735|NCT00098293|Secondary|Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96|Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.|||participants|||Number
2847736|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
2847737|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.|||participants|||Number
2847738|NCT00098293|Secondary|Time to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48, Week 96|FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|||days||95% Confidence Interval|Median
2847739|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells/µL||Standard Deviation|Mean
2847740|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.|||cells per microliter (cells/µL)||Standard Deviation|Mean
2847741|NCT00098293|Secondary|Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline up to Week 48 and Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued.|||log10 copies/mL||Standard Error|Least Squares Mean
2847742|NCT00098293|Secondary|Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm.|||log10 copies/mL||Standard Deviation|Mean
2847759|NCT00098254|Secondary|Overall Survival|Time between the first day of treatment to the days of death.|17 months||||months||95% Confidence Interval|Median
2847743|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
2847744|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
2847745|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population|Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Week 48|Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were >80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F.|||Percentage of participants|||Number
2847746|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).|||Percentage of participants|||Number
2847747|NCT00098254|Secondary|Secondary Pharmacoproteomic Modulation Targets|Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||mg/ml|||Number
2847748|NCT00098254|Secondary|Percent of Pts With Primary Pharmacoproteomic Modulation Targets|Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||mg/ml|||Number
2847749|NCT00098254|Secondary|Percentage of Participants With BRAF Mutations|Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||Percent of participants|||Number
2847750|NCT00098254|Secondary|Percent of Participants Who Had Cytokine Profiling for IL-6 and IL-8|Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.|||Percent of participants|||Number
2847751|NCT00098254|Secondary|Percent of Participants Who Had Immunohistochemical Analysis Performed for Raf, MEK, ERK, ERK-1 and p90RSK,ERK, E Twenty-six (ETS)-Like Transcription Factor 1 (ELK-1) and p90Ribosomal S6 Kinase (p90RSK).|Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).|59 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to br more important.|||Percent of participants|||Number
2847752|NCT00098254|Secondary|Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).|59 months||||Percentage of participants|||Number
2847753|NCT00098254|Secondary|Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|17 months||||months||95% Confidence Interval|Median
2847754|NCT00098254|Secondary|Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|42 months|14 patients with day 28 FGF >6 and 14 patients with FGF <6.|||months||95% Confidence Interval|Median
2847755|NCT00098254|Secondary|Correlation of Response to Treatment With KRAS Mutational Status|Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).|42 months|11/34 KRAS positive; 23/34 KRAS negative 5/23 EGFR positive; 18/23 EGFR negative|||percentage of participants|||Number
2847756|NCT00098254|Secondary|Cytokine Levels|Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|54 days||||pg/ml||Inter-Quartile Range|Median
2847761|NCT00098254|Primary|Progression Free Survival|"Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.~Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions."|17 months||||months||95% Confidence Interval|Median
2847762|NCT00098254|Primary|Response Rate|Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.|17 months||||percentage of participants||95% Confidence Interval|Number
2847763|NCT00098059|Primary|Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.|A patient with multiple AEs within the primary system organ class is counted only once in total row.|Administered 2 times daily over 7 days|Includes 47 patients enrolled in Part B of the study.|||participants|||Number
2847764|NCT00098059|Primary|Apparent Terminal Elimination Half-life of Penciclovir (T1/2)|PK parameter; penciclovir is the active metabolite of famciclovir|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.|||hours||Full Range|Mean
2847765|NCT00098059|Primary|Apparent Oral Clearance of Penciclovir (CL/F)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.|||L/h||Full Range|Mean
2847766|NCT00098059|Primary|Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.|||(μg/mL)h||Full Range|Mean
2847767|NCT00098059|Primary|Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.|||hours||Full Range|Median
2847768|NCT00098059|Primary|Maximum Observed Plasma Concentration of Penciclovir (Cmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.|||μg/mL||Full Range|Mean
2847769|NCT00098059|Primary|Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.|A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.|8 hours and 24 hours after study drug administration (Part A)|Includes all 27 patients enrolled in Part A of the study.|||participants|||Number
2847770|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study|Overall acceptability of study medication was determined by caretaker response.|Day 8 at home: after swallowing last dose|Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to <6 years and 6 to <=12 years groups.|||participants|||Number
2847771|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1 at clinic: after swallowing first dose|Includes all 47 patients enrolled in Part B of the study.|||participants|||Number
2847772|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1, after swallowing the dose.|Includes all 27 patients enrolled in Part A of the study.|||participants|||Number
2847773|NCT00098020|Secondary|Number of Patients Who Are in Complete Remission (CR) or Partial Remission (PR) at 6 Months or at the End of One Year.|Based on 24hour proteinuria, response outcomes are defined as CR (complete remission): <0.3 g/g PR (partial remission): 50% fall from baseline and <2.0 g/g|End of one year from baseline|Seven out of 8 subjects who were treated with isotretinoin completed Week 24. One out of the 7 subjected who completed Week 24 did not complete the whole study.|||Participants|||Count of Participants
2847774|NCT00098020|Primary|Change in Proteinuria at Week 24 From Baseline|Change of proteinuria at Week 24 compared to the baseline using protein/creatinine ratio (PCR)|Baseline and Week 24|A total of 7 patients is analyzed due to 1 withdrawal.|||g/g||Standard Deviation|Mean
2847775|NCT00097981|Secondary|Engraftment: Number of Participants Who Underwent Engraftment|Engraftment is the process of transplanted stem cells reproducing new cells.|From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation.|||Participants|||Number
2847776|NCT00097981|Secondary|Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
2847777|NCT00097981|Secondary|Overall Survival: Number of Participants Died Due to Any Cause||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
2847778|NCT00097981|Secondary|Time to Progression|Time to progression is the interval between the date of randomization until disease progression or death due to progression.|From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.|||Days||95% Confidence Interval|Median
2847779|NCT00097981|Secondary|Time to 1st Response|Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.|||Days||95% Confidence Interval|Median
2847780|NCT00097981|Secondary|Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)|Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
2847781|NCT00097981|Primary|Complete Response Rate: Number of Participants Who Achieved a Complete Response|Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.|||Participants|||Number
2847782|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
2847783|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
2847784|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
2847785|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
2847786|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
2847787|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.|||Percentage of patients|||Number
2847788|NCT00097773|Secondary|Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics|"The primary comparison is between the pooled culture-based group and the pooled cycled group. No interactions with ciprofloxacin were identified. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.~Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month time period|Intent to treat|||participants|||Number
2847789|NCT00097773|Secondary|Proportion of Participants With a Pa Positive Culture|"Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n=152)and pooled cipro groups (n=152).~Participants are included once in the cycled and culture-based columns, and once in the oral cipro and placebo columns"|Week 10 (after initial treatment course for Pa) through Month 18|Intent to treat|||Participants|||Number
2847790|NCT00097773|Primary|Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization|"The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.~Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month study|Intent to treat|||number of participants|||Number
2847814|NCT00097500|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
2847791|NCT00097721|Secondary|Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores|The FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.|At Screening, Day 1 of each cycle, and 30 days after last dose of study drug||||units on a scale||Full Range|Median
2847792|NCT00097721|Secondary|Overall Survival|Defined as the time from the start of study drug administration until death from any cause|From start of study drug administration to death|Per Protocol Population (Investigator Assessment)|||days||Full Range|Median
2847793|NCT00097721|Secondary|Progression Free Survival|Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.|From start of study drug administration to progressive disease or death|Per Protocol Population (Investigator Assessment)|||days||Full Range|Median
2847794|NCT00097721|Secondary|Duration of Response|Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).|From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease|Intent to Treat/Safety Population (Investigator Assessment)|||days||Full Range|Median
2847795|NCT00097721|Primary|Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Confirmed 4 to 8 weeks after first observed|Per Protocol Population (Independent Reviewer Assessment)|||percentage of participants|||Number
2847796|NCT00097708|Primary|Change in HAM-A Total Score|Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.|Baseline to week 8||||Units on a Scale||Full Range|Least Squares Mean
2847797|NCT00097695|Secondary|Time to Almost Complete Symptom Relief|The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom.|5 days||||Hours||Inter-Quartile Range|Median
2847798|NCT00097695|Secondary|Time to Regression (Start of Improvement) According to Patient|"This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked Report date and time when you feel that your symptoms start to improve."|5 days||||Hours||Inter-Quartile Range|Median
2847799|NCT00097695|Primary|Time to Onset of Symptom Relief (TOSR)|"The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line.~TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.~The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|5 days|Time to onset of symptom relief - Controlled phase - ITT population (patients experiencing moderate to very severe acute cutaneous and/or abdominal HAE attacks)|||Hours||Inter-Quartile Range|Median
2847800|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
2847801|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events|The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
2847802|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
2847803|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.|||Participants|||Number
2847815|NCT00097500|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).|Week 0 and week 52|Intent to treat population. Last observation carried forward.|||percent||Standard Error|Least Squares Mean
2847804|NCT00097591|Secondary|Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events|TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.|First dose of study drug up to 15 months (while at risk)|Treated subjects with adverse events were considered “at risk” from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects’ discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as “study drug related” were included in the “at risk” set.|||Participants|||Number
2847805|NCT00097591|Primary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug|||Participants|||Number
2847806|NCT00097539|Primary|Near Adult Height (NAH)|Heights were standardized with height standardized deviation scores (SDS) to enable height comparisons across ages and sexes using methods and height standards found at: http://www.cdc.gov/growthcharts/cdc_charts.htm. NAH were calculated overall and by etiology groups for participants who had both a non-missing value available height z-score and a non-missing enrollment height (EH) SDS, as well as for participants with 3 or more years of GH therapy (GHT ≥3y).|From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||SDS||Standard Deviation|Mean
2847807|NCT00097539|Primary|Third Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 730 days after baseline to the visit closest to 1095 days. Visits within 90 days of 730 and 1095 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 730 or 1095 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing third-year growth rate data were included in the analysis.|Year 3|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||cm/yr||Standard Deviation|Mean
2847808|NCT00097539|Primary|Second Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 365 days after baseline to the visit closest to 730 days. Visits within 90 days of 365 and 730 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365 or 730 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing second-year growth rate data were included in the analysis.|Year 2|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||cm/yr||Standard Deviation|Mean
2847809|NCT00097539|Primary|First Year Annualized Growth Rate|Annualized growth rates are expressed as centimeters per year (cm/yr), computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the first injection (baseline/ enrollment) to the visit closest to 365*1 days after baseline. Visits within 90 days of 365*1 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365*1 days was used. Growth rates less than (<) -1 or greater than (>) 30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing 1-year growth rate data were included in the analysis.|Year 1|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.|||cm/yr||Standard Deviation|Mean
2847810|NCT00097539|Primary|Number of Participants Who Died||From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population|||participants|||Number
2847811|NCT00097500|Secondary|M-value at Baseline, Week 52 and Week 56|M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population.|||mg/min/kg||Standard Error|Mean
2847812|NCT00097500|Secondary|Change in Body Weight|Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.|||kg||Standard Error|Least Squares Mean
2847813|NCT00097500|Secondary|Seven Point Self Monitored Blood Glucose (SMBG) Measurements|SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).|0 weeks and 52 weeks|Intent to treat population.|||mmol/L||Standard Deviation|Mean
2848018|NCT00095498|Secondary|Change From Baseline in Basophils at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847816|NCT00097500|Secondary|Change in Second Phase C-peptide Release|Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (-2 weeks), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.|||ratio||Standard Error|Least Squares Mean
2847817|NCT00097500|Secondary|Change in First Phase C-peptide Release|Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.|||ratio||Standard Error|Least Squares Mean
2847818|NCT00097500|Secondary|Beta-cell Function 4 Weeks After Cessation of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 56 weeks|Evaluable population|||ratio||Standard Error|Least Squares Mean
2847819|NCT00097500|Primary|Beta-cell Function After 52 Weeks of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 52 weeks|Evaluable population|||ratio||Standard Error|Least Squares Mean
2847820|NCT00097448|Primary|Hearing Improvement|Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.|2 months|Intention-to-treat|||dB||Standard Deviation|Mean
2847821|NCT00097370|Secondary|Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2847822|NCT00097370|Secondary|Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on the scale||Standard Deviation|Mean
2847823|NCT00097370|Secondary|Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score..|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2847824|NCT00097370|Secondary|Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on the scale||Standard Deviation|Mean
2847825|NCT00097370|Secondary|Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2|The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency.|up to approximately 6 years|ITT Population. Only those participants available at end of Stage 2 were included.|||Participants|||Number
2847826|NCT00097370|Secondary|Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3|Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included.|up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cell/uL||Standard Deviation|Mean
2847827|NCT00097370|Secondary|For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months)|up to approximately 6 years|ITT Population. Only those participants who entered Stage 1 from study MHE100185 with >10 mg prednisone were analyzed.|||Participants|||Number
2847828|NCT00097370|Secondary|For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months;|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who entered Stage 2 from study MHE100185 with a prednisone level of <=10 mg prednisone were analyzed.|||Participants|||Number
2847829|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level >10 mg were analyzed.|||Participants|||Number
2847830|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level <=10 mg were analyzed.|||Participants|||Number
2847831|NCT00097370|Secondary|Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study|The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint.|up to approximately 6 years|ITT Population|||Participants|||Number
2847832|NCT00097370|Secondary|Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study|Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis.|up to approximately 6 years|ITT Population|||Participants|||Number
2847833|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Follow-up Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)|Follow-up Population: subset of the modified ITT Population who had evidence of being in the study > length of dosing cycle + 7 days after the date of their last dose of study medication and up to and including 97 days after their last dose date.|||Participants|||Number
2847834|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Treatment Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)|Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of mepolizumab in this study.|||Participants|||Number
2847835|NCT00097253|Primary|Immune Function: Delayed Hypersensitivity to Candida(DTH)|DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.|Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.||||mm^2||Standard Deviation|Mean
2847836|NCT00097253|Primary|Skin Barrier Repair|TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6-50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5-7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15||||number tape strips||Standard Deviation|Mean
2847837|NCT00097253|Primary|Immune Function|Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45||||pg/ml||Standard Deviation|Mean
2847838|NCT00097253|Primary|Cortisol and Catecholamine Production|Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15||||pg/ml (log 10)||Standard Deviation|Mean
2847839|NCT00096993|Secondary|Duration of Survival|Duration of survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2847840|NCT00096993|Secondary|Percentage of Participants Free From Disease Progression at 4 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to Month 4|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2847841|NCT00096993|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. Only participants with an objective response were included in the analysis.|||months||95% Confidence Interval|Median
2847842|NCT00096993|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2847843|NCT00096993|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.|||months||95% Confidence Interval|Median
2847844|NCT00096954|Secondary|Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24|"Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.~The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing FEV1 data at either baseline or week 24 were excluded.|||percent change||Standard Deviation|Mean
2847845|NCT00096954|Secondary|Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24|"The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).~The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).~Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).~A negative change from baseline score indicates improvement."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing Asthma Symptom Score data at week 24 were excluded.|||score on a scale||Standard Deviation|Mean
2847846|NCT00096954|Secondary|Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period|The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).|||participants|||Number
2847847|NCT00096954|Primary|Rate of Asthma Exacerbations Over the 24 Week Treatment Period|"A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.~The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group."|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).|||exacerbations per 24 patient-week period|||Number
2847848|NCT00096941|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab.|||percentage of participants|||Number
2847849|NCT00096941|Primary|Percentage of Participants Who Experienced an Adverse Event||Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants|||percentage of participants|||Number
2847850|NCT00096785|Secondary|Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs|Laboratory abnormalities reported as clinical AEs|Week 48|As-treated population. 1 participant who was randomized to ADV, but treated with ETV was counted in the ETV group.|||Participants|||Number
2847851|NCT00096785|Secondary|Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths|AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= >2x baseline & >10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation.|cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset|As-treated population. 1 participant was randomized to ADV, but treated with ETV was counted in the ETV group.|||Participants|||Number
2847852|NCT00096785|Secondary|HBV DNA Viral Kinetics - Spline Model|This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||log10 copies/mL|||Number
2847853|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||hours|||Number
2847854|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||per day|||Number
2847899|NCT00096226|Secondary|Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy|Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.|At time of surgery (16-18 weeks)|Eligible patients who underwent surgery|||percentage of participants||95% Confidence Interval|Number
2848012|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 3|Laboratory hematology hematocrit|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2847855|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||percent effective|||Number
2847856|NCT00096785|Secondary|Alanine Aminotransferase (ALT) Normalization|Number of participants with ALT ≤ 1 x upper limit of normal (ULN)|Week 48|treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||participants|||Number
2847857|NCT00096785|Secondary|Viral Load Undetectable (HBV DNA <300 Copies/mL)|Number of Subjects with HBV DNA <300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL)|Week 48|Treated participants who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||Participants|||Number
2847858|NCT00096785|Secondary|Change From Baseline in HBV DNA by PCR Assay at Week 48|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement.|Baseline, Week 48|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.|||log10 c/mL||Standard Error|Mean
2847859|NCT00096785|Primary|Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.|Baseline, Week 12|As-randomized participants who completed 12 weeks of treatment|||log10 copies/mL||Standard Error|Mean
2847860|NCT00096681|Secondary|Number of Participants With a Positive HIV Test|Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.|HIV status at the time of the study visit||||Participants|||Number
2847861|NCT00096681|Primary|Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis|Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.|Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit||||Participants|||Number
2847862|NCT00096538|Primary|Tumor Response Rate Every 4 Weeks||2 years||||participants|||Number
2847863|NCT00096486|Primary|Overall Objective Response|Determine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|2 years||||participants|||Number
2847864|NCT00096460|Primary|Lymphoma Progression-free Survival||Three years post-Hematopoietic Stem Cell Transplant (HSCT)||||participants|||Number
2847865|NCT00096447|Secondary|Prognostic Factor (Histologic Grade)|G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.|Baseline|Eligible and evaluable|||Participants|||Count of Participants
2847866|NCT00096447|Secondary|Prognostic Factors (Performance Status)|"Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.~Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work."|Baseline|Eligible and evaluable|||Participants|||Count of Participants
2847867|NCT00096447|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||Months||95% Confidence Interval|Median
2847868|NCT00096447|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and evaluable patients|||months||Inter-Quartile Range|Median
2847869|NCT00096447|Secondary|Percentage of Patients With Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2847870|NCT00096447|Primary|Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|The frequency and severity of all toxicities are tabulated.|Every cycle during treatment and 30 days after the last cycle of therapy.|Eligible and evaluable patients|||Participants|||Count of Participants
2847978|NCT00095563|Secondary|Rate of Stable Disease|Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC)|6 months|36 assessable participants, 19 with ACC and 17 with non-ACC.|||participants|||Number
2847871|NCT00096447|Primary|Percentage of Patients With Progression-free Survival > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2847872|NCT00096382|Primary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years||||Participants|||Number
2847873|NCT00096382|Primary|Clinical Tumor Regression|Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.||||Participants|||Number
2847874|NCT00096356|Secondary|Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization|CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.|24 weeks||||units on a scale||Standard Error|Least Squares Mean
2847875|NCT00096356|Secondary|Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization|FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.|24 weeks||||units on a scale||Standard Error|Least Squares Mean
2847876|NCT00096356|Primary|Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization|POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.|24 weeks||||units on a scale||Standard Error|Least Squares Mean
2847877|NCT00096278|Other Pre-specified|Proteinuria After Completion of Bevacizumab||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months|||||||
2847878|NCT00096278|Other Pre-specified|Proteinuria With Clinical Sequelae||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months|||||||
2847879|NCT00096278|Other Pre-specified|The Risk Factors for Development of Proteinuria||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months|||||||
2847880|NCT00096278|Other Pre-specified|As Measured by Blood Pressure and Antihypertensive Medication Hypertension||Group 2, every 3 months for one year post treatment|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
2847881|NCT00096278|Other Pre-specified|Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab||Events measured regularly during chemotherapy and bevacizumab therapy|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
2847882|NCT00096278|Other Pre-specified|Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test||Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
2847883|NCT00096278|Other Pre-specified|Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab||Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy|Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.||||||
2847884|NCT00096278|Secondary|Survival|Percentage of patients who did not experience an event where events are defined as death from any cause.|5 years|Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis.|||percentage of patients|||Number
2847885|NCT00096278|Primary|Disease-free Survival|Where events are defined as recurrence, second primary cancer, or death from any cause|3 years||||percentage of patients|||Number
2847886|NCT00096265|Secondary|Cause of Death (Neurologic vs Other)|"Patients were considered to have died neurologic deaths (coded as Brain Metastases) if they had stable systemic disease and progressive neurologic disease consisting of expanding intracranial masses, CNS hemorrhages, hydrocephalus resulting in herniation or fulminant meningeal carcinomatosis."|From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|Eligible patients who died|||Participants|||Count of Participants
2847887|NCT00096265|Secondary|Change in Steroid Dependence at Six Months|Daily steroid dose will be collected at baseline and follow-up, as one of the following: 0-4 mg, >4 to ≤ 8 mg, >8 to ≤12 mg, and >12 mg. Change from baseline at six months will be evaluated to have decreased, remained stable, or increased, based on these categories.|From randomization to six months.|Eligible patients with both baseline and 6 month steroid dose|||Participants|||Count of Participants
2847888|NCT00096265|Secondary|Change in Performance Status at Six Months|Compared between two treatment arms using a two-group chi-squared test. Zubrod score will be collected at baseline and follow-up. The Zubrod performance score runs from 0 to 5, with 0 denoting perfect health and 5 death. Change from baseline is calculated as 6-month value - baseline value. Patients with a baseline score who have died by six months will be included in the analysis with a score of 5 at six months.|From randomization to six months.|Eligible patients with baseline and 6 month data|||Participants|||Count of Participants
2847889|NCT00096265|Secondary|Change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score at 3 Months|The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score, which ranges from 0 to 76. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-Br including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL. A change of 5 points will be considered a minimal clinically meaningful change. Change from baseline at three months (3 month score - baseline score) will be categorized as improvement if increased, stable if no change, or deterioration if decreased.|From randomization to three months.|Eligible patients with both baseline and 3 month data|||Participants|||Count of Participants
2847890|NCT00096265|Secondary|Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument|Quality-adjusted life years (QALY) incorporate the societal-based utilities of health states into expected life years for a health condition. The QALY model is QALY(h,y) where h is a health state and y is the years of life. Higher quality-adjusted life year values represent a better outcome. A patient's health state will be determined from the index score of the EQ-5D-5L patient questionnaire.The EQ-5D-5L is a 2-part self-assessment questionnaire, a 5-item index score and a visual analogue scale, but only the index score is used for quality-adjusted survival. The index score has 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state).|From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|Eligible patients with any follow-up EQ-5D|||Quality-adjusted life years||Standard Deviation|Mean
2847891|NCT00096265|Secondary|Rate of CNS Progression (One Year)|CNS progression is defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression). For lesions smaller than 1 cm in maximum diameter, a maximum increase of 50% in perpendicular bi-dimensional treatment area is necessary to score as progression. This caveat is included to account for potential variability in measurement, which is most susceptible to proportionate errors at smaller sizes. For greater than 1 cm lesions, the definition uses a 25% rule for change. Rates of CNS progression estimated by the cumulative incidence method, with death treated as a competing risk.|From randomization to last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2847892|NCT00096265|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.|From randomization to date of death or last follow-up, up to 48.1 months. Analysis occurs after all patients have been potentially followed for 9 months.|All eligible patients.|||months||95% Confidence Interval|Median
2847893|NCT00096226|Secondary|Distribution of Highest Grade Adverse Event|The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.|From start of treatment to end of follow-up, a maximum of 64.3 months|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2847894|NCT00096226|Secondary|Progression-free Survival at Two Years|Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.|From registration to two years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2847895|NCT00096226|Secondary|Overall Survival at Two Years|Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to two years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2847896|NCT00096226|Secondary|Distribution of R0, R1, and R2 Resections After Chemotherapy|An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.|At time of surgery (16-18 weeks)|Eligible patients who underwent surgery|||percentage of participants||95% Confidence Interval|Number
2847897|NCT00096226|Secondary|Percentage of Patients Able to Undergo Surgical Resection||At time of surgery (16-18 weeks)|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2847898|NCT00096226|Secondary|Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery|The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.|From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)|Eligible patients who underwent surgery|||percentage of participants||95% Confidence Interval|Number
2847900|NCT00096226|Primary|Mediastinal Nodal Clearance Rate|If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.|At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.|Eligible patients who had adequate pathologic information of mediastinal nodal status.|||participants|||Number
2847901|NCT00096200|Secondary|Overall Survival|Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.|up to 85 months of follow-up|Subjects that received at least 2 cycles of treatment|||months||95% Confidence Interval|Median
2847902|NCT00096200|Secondary|Evaluate the Progression-free Survival Rate|Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.|up to 85 months of follow-up|Subjects who completed at least 2 cycles of therapy|||months||95% Confidence Interval|Median
2847903|NCT00096200|Primary|Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.|after 6 weeks (2 cycles)|Patients that received 2 cycles of treatment. Includes results from patients that crossed over to Arm C.|||participants|||Number
2847904|NCT00096174|Secondary|Overall Response Rate|Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients|assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry|Eligible and treated|||proportion of participants||90% Confidence Interval|Number
2847905|NCT00096174|Secondary|2-year Overall Survival Rate|Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.|assessed very 3 months for 2 years|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
2847906|NCT00096174|Primary|2-year Progression-free Survival Rate|Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.|assessed every 3 months for 2 years|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
2847907|NCT00096161|Secondary|Survival|Percentage patients surviving.|1 year after DLI|No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.|||percentage of participants|||Number
2847908|NCT00096161|Secondary|Incidence of Relapse/Progression|"CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever >38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes >20%.~AML, ALL, CMML >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions."|1 year after DLI|No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.|||percentage of participants|||Number
2847909|NCT00096161|Secondary|Incidence of Infections||100 days after DLI|No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.|||percentage of participants|||Number
2847910|NCT00096161|Secondary|Incidence of GVHD|"Percentage patients with acute or chronic GVHD.~The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD."|1 year after DLI|No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.|||percentage of participants|||Number
2847911|NCT00096161|Primary|Incidence of Grade IV Acute GVHD|"Clinical Stage of acute GVHD according to Organ System~Skin:~- Maculopapular rash <25% of body surface~- Maculopapular rash 25-50% of body surface~- Maculopapular rash >50% body surface area or generalized erythroderma~- Generalized erythroderma with bullous formation and desquamation~Liver:~- Bilirubin 2-3 mg/dl~- Bilirubin 3.1-6 mg/dl~- Bilirubin 6.1-15 mg/dl~- Bilirubin >15 mg/dl~Gut:~- >500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD~- >1000 -1500 mL diarrhea per day~- >1500 mL diarrhea per day~- >1500 mL diarrhea per day plus severe abdominal pain with or without ileus~Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI"|Within 100 days after the last DLI|No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.|||percentage of participants|||Number
2848013|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 1|Laboratory hematology hematocrit|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2847912|NCT00096161|Primary|Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism|"A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements.~Chimerism in hematopoietic cell transplant derives from this idea of a mixed entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells."|From the time of enrollment maintained to day 56 after the last DLI, up to Day 112|No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.|||percentage of participants|||Number
2847913|NCT00096135|Primary|Event-free Survival|Monitoring of efficacy results will be performed in comparison with historical results.|3 years|The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.|||percentage of participants|||Number
2847914|NCT00096122|Primary|Number of Participants With Complete Response|Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L.|21 Day Cycle|Analysis was per protocol.|||Participants|||Number
2847915|NCT00096109|Primary|Her2/Neu Status|"Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals.~PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED."|Baseline|No participants were evaluated for her2/neu status.||||||
2847916|NCT00096109|Primary|Progression Free Survival (PFS)|PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 7 years||||months||95% Confidence Interval|Median
2847917|NCT00096109|Primary|Response Rate (Complete Response (CR) +Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 7 years||||Participants|||Count of Participants
2847918|NCT00096044|Secondary|Time to Progression for the Combination Therapy of CC-5013+Rituximab|Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.|Every month up to 6 months and every 3 months thereafter up to 5 years|All treated with combination therapy of CC-5013+Rituximab and eligible patients|||months||95% Confidence Interval|Median
2847919|NCT00096044|Secondary|Time to Progression for Single Agent CC-5013|Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.|5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2847920|NCT00096044|Secondary|Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab|Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0|Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.|All treated with combination therapy of CC-5013+Rituximab and eligible patients|||Participants|||Count of Participants
2847921|NCT00096044|Secondary|Number of Participants With Adverse Events on Single Agent CC-5013|"Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0~Please refer to the adverse event reporting for more detail."|1 year|All treated and eligible patients|||Participants|||Count of Participants
2847922|NCT00096044|Secondary|Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab|Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.|5 years|All treated with combination therapy of CC-5013+Rituximab and eligible patients|||percentage of participants||95% Confidence Interval|Number
2847923|NCT00096044|Primary|Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months|Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.|at 6 Months|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2847924|NCT00096031|Secondary|Time to Progression|Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|every 3 weeks while on treatment, then every 3 months for 3 years||||months||95% Confidence Interval|Median
2847925|NCT00096031|Secondary|Time to Treatment Failure|Time to treatment failure is measured from date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|every 3 weeks while on treatment||||months||95% Confidence Interval|Median
2847926|NCT00096031|Primary|Overall Survival at 6 Months|Time to death is measured from date of registration to date of death due to any cause.|every 3 weeks while on treatment, then every 3 months||||percentage of participants||95% Confidence Interval|Number
2847927|NCT00096018|Primary|Duration of Response||4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|Patients with Complete or Partial Response|||months||Standard Deviation|Mean
2847928|NCT00096018|Primary|Overall Responders (Complete and Partial Response)|Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)|4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|All Treated Patients|||participants|||Number
2847929|NCT00095979|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients|||months||95% Confidence Interval|Median
2847930|NCT00095979|Secondary|Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
2847931|NCT00095979|Primary|Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)||Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)|Eligible and treated patients|||Participants|||Count of Participants
2847932|NCT00095979|Primary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2847933|NCT00095940|Secondary|Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective)|Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.|||Participants|||Number
2847934|NCT00095940|Secondary|Number of Participants With Tumors Expressing Total ERBB2|Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.|||Participants|||Number
2847979|NCT00095563|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|This assessment was not performed since no participants showed a response.||||||
2847935|NCT00095940|Secondary|Maximum Concentration of Lapatinib in Plasma (Phase II Objective)|Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1.|First dose of lapatinib in course 1|The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1.|||nanogram/milliliter||Full Range|Median
2847936|NCT00095940|Secondary|Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective)|For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma.|First dose of lapatinib prior to surgery|The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib.|||percent||Full Range|Median
2847937|NCT00095940|Primary|Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective)|A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups.|From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma)|Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable.|||Participants|||Number
2847938|NCT00095940|Primary|Relative Phosphorylation of ERBB2 (Molecular Biology Objective)|Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division.|7-14 days after starting therapy and prior to surgery|Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met.|||ratio||Full Range|Median
2847939|NCT00095875|Secondary|Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years|Progression free survival was defined as the time from date of randomisation to disease progression or death from any cause without progression whichever occurred first; otherwise, patients were censored at the date last known to be free of progression.|5 years||||percent of patients||95% Confidence Interval|Number
2847940|NCT00095875|Primary|Overall Survival|To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival|3-years||||percent of patients||95% Confidence Interval|Number
2847941|NCT00095836|Secondary|Overall Survival|The median overall survival time, measured from the time of enrollment until death.|5 years||||Months||Full Range|Median
2847942|NCT00095836|Secondary|Median Progression-free Survival|"The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions."|From the time of enrollment until disease progression or death, whichever came first||||Months||95% Confidence Interval|Median
2847943|NCT00095836|Secondary|Toxicity|Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients|Through study completion, on average 12 months||||participants|||Number
2847944|NCT00095836|Primary|Objective Tumor Response Rate at 3, 6, and 12 Months|"Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year.~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|3 Months, 6 Months, 1 Year|Two patients lost to follow-up prior to assessment of tumor response|||participants|||Number
2847945|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 12|Seven patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
2848004|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 3|Laboratory hematology lymphocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2847946|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 5|Seven patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
2847947|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 1|Nine patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
2847948|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 12|Three patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
2847949|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 5|Three patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
2847950|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 1|Four patients had missing data.|||percentage of HbF||95% Confidence Interval|Mean
2847951|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 12|Eleven patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
2847952|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 5|Seven patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
2847953|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 1|Seven patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
2847954|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 12|Three patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
2847955|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 5|Three patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
2847956|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 1|Four patients had missing data.|||ratio||95% Confidence Interval|Geometric Mean
2847957|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 12|Six patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
2847958|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 5|Six patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
2847959|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 1|Five patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
2847960|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 12|Three patients had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
2847961|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 5|One patient had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
2847962|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 1|One patient had missing data.|||cells x 10^6/L||95% Confidence Interval|Geometric Mean
2847963|NCT00095784|Primary|Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|Percentage of patients experiencing any toxicity, any grade level. Additional details on adverse events are reported in Adverse Events section.|Up to 30 days of last dose of decitabine||||percentage of patients||95% Confidence Interval|Number
2847964|NCT00095784|Primary|Response Rate (Complete Response, Partial Response, or Hematologic Improvement.|"Complete response is normalization of counts and transfusion-independence.~Partial response is hemoglobin increase to normal levels, multilineage improvement including absolute neutrophil count (ANC) and/or platelets.~Hematologic improvement is red cell transfusion-independence or >50% increase in platelet levels."|Up to 36 weeks (6 cycles)|Two patients were non-evaluable for response.|||percentage of participants||90% Confidence Interval|Number
2847965|NCT00095628|Other Pre-specified|1 Year Overall Survival|Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.|12 months||||percentage of participants||95% Confidence Interval|Number
2847966|NCT00095628|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.|Up to 18 months||||months||95% Confidence Interval|Median
2847967|NCT00095628|Secondary|Median Overall Survival of SB-715992|Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.|Up to 18 months||||months||95% Confidence Interval|Median
2847968|NCT00095628|Secondary|Number of Participants With Clinical and Objective Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.|Up to 18 months||||participants|||Number
2847969|NCT00095628|Secondary|Duration of Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion|Up to 18 months|Data were not collected because 0 participants showed a response.||||||
2847970|NCT00095628|Primary|Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion|Up to 18 months|20 eligible patients were analyzed|||participants|||Number
2847971|NCT00095576|Primary|HIV-1 Viral Load in Infected Participants|Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.||||||
2847972|NCT00095576|Primary|Number of Participants With HIV-1 Infections|The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.||||||
2847973|NCT00095576|Primary|Number of Participants With Laboratory Adverse Experiences|"Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.~Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.~All laboratory AEs were collected up to 14 days after any vaccine dose."|Day 1 to Week 208||||Participants|||Number
2847974|NCT00095576|Primary|Number of Participants With Clinical Adverse Experiences|"Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.~AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).~Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose."|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)||||Participants|||Number
2847975|NCT00095563|Secondary|Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading|Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.|Up to 5 years||||participants|||Number
2847976|NCT00095563|Secondary|Overall Survival (OS)|Survival estimates will be computed using the Kaplan-Meier method.|From the date of study enrolment to death or last contact, assessed up to 5 years|20 participants with ACC, 19 participants with non-ACC.|||months||95% Confidence Interval|Median
2847977|NCT00095563|Secondary|Progression-free Survival (PFS) According to RECIST||From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years|36 assessable participants, 19 with ACC and 17 with non-ACC.|||months||95% Confidence Interval|Median
2848333|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
2847980|NCT00095563|Primary|Objective Response Rates (Partial and Complete Responses)|Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;|Up to 5 years|36 assessable participants.|||participants|||Number
2847981|NCT00095498|Secondary|Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3|"Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline:~Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE."|Month 1, month 3, month 6, month 12|Patients who received at least 1 dose of investigational product.|||Participants|||Number
2847982|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847983|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2847984|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 3|Laboratpry hematology white blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2847985|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2847986|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847987|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2847988|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 3|Laboratory hematology red blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2847989|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2847990|NCT00095498|Secondary|Change From Baseline in Platelets at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847991|NCT00095498|Secondary|Change From Baseline in Platelets at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2847992|NCT00095498|Secondary|Change From Baseline in Platelets at Month 3|Laboratory hematology platelets|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2847993|NCT00095498|Secondary|Change From Baseline in Platelets at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2847994|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847995|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2847996|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 3|Laboratory hematology total neutrophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2847997|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2847998|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2847999|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2848000|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 3|Laboratory hematology monocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2848001|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||* 10^9/L||Standard Deviation|Mean
2848002|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||* 10^9/L||Standard Deviation|Mean
2848003|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2848019|NCT00095498|Secondary|Change From Baseline in Basophils at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||* 10^9/L||Standard Deviation|Mean
2848020|NCT00095498|Secondary|Change From Baseline in Basophils at Month 3|Laboratory hematology basophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||* 10^9/L||Standard Deviation|Mean
2848021|NCT00095498|Secondary|Change From Baseline in Basophils at Month 1|Laboratory hematology basophils|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||*10^9/L||Standard Deviation|Mean
2848022|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
2848023|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
2848024|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 3|Laboratory Chemistry alanine amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
2848025|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
2848026|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
2848027|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
2848028|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 3|Laboratory chemistry aspartate amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
2848029|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
2848030|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||g/L||Standard Deviation|Mean
2848031|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||g/L||Standard Deviation|Mean
2848032|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 3|Laboratory chemistry total protein|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||g/L||Standard Deviation|Mean
2848033|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||g/L||Standard Deviation|Mean
2848034|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 12|Change From Baseline in Phosphorus at Month 12|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848035|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 6|Laboratory chemistry phosphorus|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848036|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 3|Laboratory chemistry phosphorus|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848037|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 1|Laboratory chemistry phosphorus|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848038|NCT00095498|Secondary|Change From Baseline in Sodium at Month 12|Laboratory chemistry sodium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848039|NCT00095498|Secondary|Change From Baseline in Sodium at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848040|NCT00095498|Secondary|Change From Baseline in Sodium at Month 3|Change From Baseline in Sodium at Month 3|Baseline, Month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848041|NCT00095498|Secondary|Change From Baseline in Sodium at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848042|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848043|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848044|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 3|Laboratory chemistry magnesium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848045|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848046|NCT00095498|Secondary|Change From Baseline in Potassium at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848047|NCT00095498|Secondary|Change From Baseline in Potassium at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848048|NCT00095498|Secondary|Change From Baseline in Potassium at Month 3|Laboratory chemistry potassium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848049|NCT00095498|Secondary|Change From Baseline in Potassium at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848050|NCT00095498|Secondary|Change From Baseline in Glucose at Month 12|Laboratory chemistry glucose|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848051|NCT00095498|Secondary|Change From Baseline in Glucose at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848052|NCT00095498|Secondary|Change From Baseline in Glucose at Month 3|Laboratory chemistry glucose|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848053|NCT00095498|Secondary|Change From Baseline in Glucose at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848054|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 12|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
2848055|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 6|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
2848056|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 3|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
2848057|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 1|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
2848058|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||µmol/L||Standard Deviation|Mean
2848059|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||µmol/L||Standard Deviation|Mean
2848060|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 3|Laboratory chemistry creatinine|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||µmol/L||Standard Deviation|Mean
2848061|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||µmol/L||Standard Deviation|Mean
2848062|NCT00095498|Secondary|Change From Baseline in Chloride at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848063|NCT00095498|Secondary|Change From Baseline in Chloride at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848064|NCT00095498|Secondary|Change From Baseline in Chloride at Month 3|Laboratory chemistry chloride|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848065|NCT00095498|Secondary|Change From Baseline in Chloride at Month 1|Laboratory chemistry chloride|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848066|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 12|Laboratory chemistry albumin-adjusted calcium|Baselien, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848067|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 6|Laboratory chemistry albumin-adjusted calcium|Baseline, Month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848068|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 3|Laboratory chemistry albumin-adjusted calcium|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848069|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 1|Laboratory chemistry albumin-adjusted calcium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848070|NCT00095498|Secondary|Change From Baseline in Calcium at Month 12|Laboratory chemistry calcium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848071|NCT00095498|Secondary|Change From Baseline in Calcium at Month 6|Laboratory chemistry calcium|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848072|NCT00095498|Secondary|Change From Baseline in Calcium at Month 3|Laboratory chemistry calcium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848073|NCT00095498|Secondary|Change From Baseline in Calcium at Month 1|Laboratory chemistry calcium|baseline. month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848074|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 12|Laboratory chemistry blood urea nitrogen|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848075|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848076|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 3|Laboratory chemistry blood urea nitrogen|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848077|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848078|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||umol/L||Standard Deviation|Mean
2848079|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||umol/L||Standard Deviation|Mean
2848080|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 3|Laboratory chemistry total bilirubin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||umol/L||Standard Deviation|Mean
2848081|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 1|Laboratory chemistry total bilirubin|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||umol/L||Standard Deviation|Mean
2848082|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 12|Laboratory chemistry bicarbonate|Baseline, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||mmol/L||Standard Deviation|Mean
2848083|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||mmol/L||Standard Deviation|Mean
2848084|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 3|Laboratory chemistry bicarbonate|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||mmol/L||Standard Deviation|Mean
2848085|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 1|Laboratory chemistry bicarbonate|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||mmol/L||Standard Deviation|Mean
2848086|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 12|Laboratory chemistry alkaline phosphatase|baseine, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||U/L||Standard Deviation|Mean
2848087|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 6|Laboratory chemistry alkaline phosphatase|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||U/L||Standard Deviation|Mean
2848088|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 3|Laboratory chemisrty alkaline phosphatase|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||U/L||Standard Deviation|Mean
2848089|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 1|Laboratory chemistry alkaline phoshatatse|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||U/L||Standard Deviation|Mean
2848090|NCT00095498|Secondary|Change From Baseline in Albumin at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.|||g/L||Standard Deviation|Mean
2848091|NCT00095498|Secondary|Change From Baseline in Albumin at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.|||g/L||Standard Deviation|Mean
2848092|NCT00095498|Secondary|Change From Baseline in Albumin at Month 3|Laboratory chemistry albumin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.|||g/L||Standard Deviation|Mean
2848093|NCT00095498|Secondary|Change From Baseline in Albumin at Month 1|Laboratory Chemistry Albumin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.|||g/L||Standard Deviation|Mean
2848334|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
2848094|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody|Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.|Baseline to Month 12|Patients who were positive for anti-denosumab antibodies|||Participants|||Number
2848095|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibodies|Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported.|Assessed at Baseline and at Months 1, 3, 6 and 12.|Patients who received at least 1 dose of investigational product and with at least one postbaseline sample taken.|||Participants|||Number
2848096|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12|Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848097|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6|Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848098|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3|Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848099|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 12|Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848100|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 6|Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848101|NCT00095498|Secondary|Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3|Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848102|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 12|Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848103|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 6|Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848104|NCT00095498|Secondary|Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3|Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.|||Percent change from baseline||Inter-Quartile Range|Median
2848105|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Standard Error|Least Squares Mean
2848106|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Standard Error|Least Squares Mean
2848335|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||x 10^3 cells/microliter||Standard Error|Mean
2848107|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.|||Percent change from baseline||Standard Error|Least Squares Mean
2848108|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Standard Error|Least Squares Mean
2848109|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Standard Error|Least Squares Mean
2848110|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1|"Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100.~Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic)."|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.|||Percent change from baseline||Standard Error|Least Squares Mean
2848111|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||Percent change from baseline||Standard Error|Least Squares Mean
2848112|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||Percent change from baseline||Standard Error|Least Squares Mean
2848113|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.|||Percent change from baseline||Standard Error|Least Squares Mean
2848114|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Inter-Quartile Range|Median
2848115|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||units on a scale||Inter-Quartile Range|Median
2848126|NCT00095303|Secondary|Follow Up Study, Level of Family Functioning|For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.|90 days prior assessment||||units on a scale||Standard Deviation|Mean
2848116|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 6|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Inter-Quartile Range|Median
2848117|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 12|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||units on a scale||Inter-Quartile Range|Median
2848118|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Inter-Quartile Range|Median
2848119|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.|||units on a scale||Inter-Quartile Range|Median
2848120|NCT00095498|Primary|Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6|Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism [EULAR]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.|||units on a scale||Full Range|Median
2848121|NCT00095303|Secondary|Follow Up Study, Risky Sexual Behaviors|For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.|90 days prior assessment||||units on a scale||Standard Error|Least Squares Mean
2848122|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 12 Months Post Randomization|For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.|12 months post randomization||||units on a scale||Standard Error|Least Squares Mean
2848123|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 8 Months Post Randomization|For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.|8 months post randomization||||units on a scale||Standard Error|Least Squares Mean
2848124|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 4 Months Post Randomization|For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.|4 months post randomization||||units on a scale||Standard Error|Least Squares Mean
2848125|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at Baseline|For the Main Study, the total score of the 'HIV/Sex Risk Behaviors' measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.|Baseline||||units on a scale||Standard Error|Least Squares Mean
2848501|NCT00094328|Primary|Change in Growth Rate (cm/Year)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).|Assessed after 12 months treatment|All treated (AT) set|||cm/year||Standard Deviation|Mean
2848127|NCT00095303|Secondary|Main Study, Level of Family Functioning at 12 Months Post Randomization|The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.|12 months post randomization||||units on a scale||Standard Deviation|Mean
2848128|NCT00095303|Secondary|Main Study, Level of Family Functioning at 8 Months Post Randomization|The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.|8 months post randomization||||units on a scale||Standard Deviation|Mean
2848129|NCT00095303|Secondary|Main Study, Level of Family Functioning at 4 Months Post Randomization|The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.|4 months post randomization||||units on a scale||Standard Deviation|Mean
2848130|NCT00095303|Secondary|Main Study, Level of Family Functioning at Baseline|The four components of the 'Parenting Practices Inventory' used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.|Baseline||||units on a scale||Standard Error|Mean
2848131|NCT00095303|Secondary|Follow Up Study, Externalizing Behavior|For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression|90 days prior to assessment||||units on a scale||Standard Deviation|Mean
2848132|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior to assessment||||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
2848133|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior assessment||||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
2848134|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 337-364|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 337-364. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 337-364||Inter-Quartile Range|Median
2848160|NCT00095238|Secondary|Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants|||Participants|||Number
2848135|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 309-336|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 309-336. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 309-336||Inter-Quartile Range|Median
2848136|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use from days 281-308|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 281-308. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 281-308||Inter-Quartile Range|Median
2848137|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 253-280|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 253-280. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 253-280||Inter-Quartile Range|Median
2848138|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 225-252|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 225-252. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 225-252||Inter-Quartile Range|Median
2848139|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 197-224|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 197-224. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 197-224||Inter-Quartile Range|Median
2848161|NCT00095238|Secondary|Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.||||participants|||Number
2848140|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 169-196|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 169-196. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 169-196||Inter-Quartile Range|Median
2848141|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 141 - 168|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 141-168. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 141-168||Inter-Quartile Range|Median
2848142|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 113-140|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 113-140. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from days 113-140||Inter-Quartile Range|Median
2848143|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 85-112|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 85-112. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 85-112||Inter-Quartile Range|Median
2848144|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 57-84|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 57-84. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 57-84||Inter-Quartile Range|Median
2848162|NCT00095238|Secondary|Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit|NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.|Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized participants with measurement at baseline and Month 6, Month 10, Month 14, and Final Visit|||participants|||Number
2848145|NCT00095303|Secondary|Main Study, Externalizing Behavior at 12 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.|12 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 12 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
2848146|NCT00095303|Secondary|Main Study, Externalizing Behavior at 8 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.|8 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 8 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
2848147|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days in days 29-56|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 29-56. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use in days 29-56||Inter-Quartile Range|Median
2848148|NCT00095303|Secondary|Main Study, Externalizing Behavior at 4 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.|4 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 4 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
2848149|NCT00095303|Secondary|Main Study, Externalizing Behaviors at Baseline|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: 'Total Delinquency' from the National Youth Survey; 'Oppositional Defiant Disorder' and 'Conduct Problems' from the Diagnostic Interview Schedule for Children-Predictive Scales, 'Externalizing Scale' from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.|Baseline|The number of participants analyzed represents the number of participants that completed this time point, assessing externalizing behaviors at baseline. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||units on a scale||Standard Deviation|Mean
2848150|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 1-28|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 1-28. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use from day 1-28||Inter-Quartile Range|Median
2848163|NCT00095238|Secondary|Percentage of Participants Experiencing All-cause Death at Given Time Points|Treatment comparisons for time to all-cause death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized subjects|||percentage of participants|||Number
2848151|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from 28 days prior to baseline|The number of participants analyzed represents the number of participants that completed the baseline time point, assessing for the past 28 days. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.|||days of drug use 28 days prior baseline||Inter-Quartile Range|Median
2848152|NCT00095238|Secondary|Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)|Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.|Baseline, Final Visit|Randomized subjects (total=4128) with no prior AF history or evidence of AF on baseline ECG, stratified by use of ACE-I|||participants|||Number
2848153|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 42, Month 54, Month 66|Participants with baseline score and score at timepoint.|||mL/min/1.73m2||Standard Error|Mean
2848154|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 6, Month 18, Month 30|Participants with baseline score and score at timepoint.|||mL/min/1.73m2||Standard Error|Mean
2848155|NCT00095238|Secondary|Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints|Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized participants with no prior diabetes history|||percentage of participants|||Number
2848156|NCT00095238|Secondary|Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5||||percentage of participants|||Number
2848157|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints|Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5|randomized participants|||percentage of participants|||Number
2848158|NCT00095238|Secondary|Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants|||Participants|||Number
2848159|NCT00095238|Secondary|Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants|||Participants|||Number
2848164|NCT00095238|Secondary|Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints|Treatment comparisons for time to cardiovascular death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Subjects|||percentage of participants|||Number
2848165|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints|Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants|||percentage of participants|||Number
2848166|NCT00095238|Secondary|Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14|Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.|Baseline, Month 6, Month 14|number of participants with measurement at baseline and at timepoint|||pg/mL||Standard Error|Geometric Mean
2848167|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit|Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Participants with baseline score and score at timepoint.|||units on a scale||Standard Error|Mean
2848168|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14|Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Month 6, Month 14|Participants with baseline score and score at timepoint.|||units on a scale||Standard Error|Mean
2848169|NCT00095238|Secondary|Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points|Treatment comparisons for time to heart failure mortality or heart failure hospitalization|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants|||percentage of participants|||Number
2848170|NCT00095238|Primary|Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants|||percentage of participants|||Number
2848171|NCT00095212|Secondary|Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.|||kilograms||Standard Error|Mean
2848172|NCT00095212|Secondary|Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.|||kilograms||Standard Error|Mean
2848173|NCT00095212|Secondary|"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."|This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the testing|||Units on a scale||Standard Error|Mean
2848174|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
2848175|NCT00095212|Secondary|Safety: Number of Subjects Reporting Acne|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
2848176|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
2848177|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Skin Reaction to the Patch|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months||||participants|||Number
2848178|NCT00095212|Secondary|Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function|Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the questionnaire|||Units on a scale||Standard Error|Mean
2848179|NCT00095212|Secondary|Quality of Life/Depression: Becks Depression Inventory|Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck's Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (time 0) to 18 months||||Units on a scale||Standard Error|Mean
2848180|NCT00095212|Secondary|Bone Mineral Density of the Hip|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months||||grams per centimeter squared||Standard Error|Mean
2848181|NCT00095212|Primary|Lean Body Mass|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months|Responses at 9 and 18 months were pooled as the post treatment repeated measures. All data were included in the analysis, including 9 month data from the 4 subjects who discontinued after the 9 month visit.|||kilograms||Standard Error|Mean
2848182|NCT00095199|Secondary|Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities|National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities. Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. Participants reported had grade 3 or 4 toxicities (or both potentially). Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 AEs: life-threatening consequences; urgent intervention indicated.|Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)|All randomized participants receiving at least 1 dose of study drug made up the safety population for this outcome measure. Investigators graded events using CTCAE v3.0. Mapping of investigator verbatim terms for toxicity to CTCAE terms was done by the sponsor/designee using CTCAE v4.0.|||participants|||Number
2848183|NCT00095199|Secondary|Duration of Overall Response (OR)|The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death. Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment. The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group.|Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months|All randomized participants with a best overall response of CR or PR. Censored participants: 1 in Cetuximab plus Pemetrexed arm; 2 in Pemetrexed arm; 1 in Cetuximab plus Docetaxel arm; 0 in Docetaxel arm.|||months||95% Confidence Interval|Median
2848184|NCT00095199|Secondary|Time to Symptomatic Progression|The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms. Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and <5 weeks, apart. The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline. Time to symptomatic progression = the time from randomization to the symptom progression date. For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment.|Randomization until symptomatic progression up to 48.3 months|All randomized participants with a baseline LCS >= 2 were included. Censored participants: 237 in Cetuximab plus Pemetrexed arm; 244 in Pemetrexed arm; 126 in Cetuximab plus Docetaxel arm; 131 in Docetaxel arm.|||months||95% Confidence Interval|Median
2848185|NCT00095199|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)|The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms. Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). Scores range from 0-28 and higher score indicates fewer symptoms. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not >5 weeks apart for participants, whose baseline LCS score was ≤26. Symptom response rate was the percentage of participants with symptomatic response.|At baseline, every 3 weeks and 30 days after end of therapy up to 50 months|The randomized participants with baseline LCS scores less than or equal to 26.|||percentage of participants||95% Confidence Interval|Number
2848213|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of red blood cells||Standard Error|Mean
2848186|NCT00095199|Secondary|Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)|The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2848187|NCT00095199|Secondary|Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])|The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm. Participants with no post-baseline evaluation were considered as non-responders. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization until progression of disease or death from any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.|||proportion of participants||95% Confidence Interval|Number
2848188|NCT00095199|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.|Randomization to the date of death from any cause up to 72.8 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 24 in Cetuximab + Pemetrexed arm; 43 in Pemetrexed arm; 12 in Cetuximab + Docetaxel arm; 22 in Docetaxel arm.|||months||95% Confidence Interval|Median
2848189|NCT00095199|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab & Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab & Docetaxel versus Docetaxel).|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 10 in Cetuximab + Pemetrexed arm; 25 in Pemetrexed arm; 6 in Cetuximab + Docetaxel arm; 16 in Docetaxel arm.|||months||95% Confidence Interval|Median
2848190|NCT00095173|Secondary|Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)|During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.|Period C (Day 282 to 85 days after the last dose of study medication)|All treated participants who were evaluated for immunogenicity during Period C|||participants|||Number
2848191|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)|Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,<1.00x10^3 c/uL;Abs Lymphocytes,<0.72x10^3 or>7.50x10^3 c/uL;Abs Eosinophils,>0.750X10^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,>=4;Urine Glucose,>=4;Urine Blood,>=4;Urine Red Blood Cells>=4;Urine White Blood Cells,>=4.|Period C (Day 282 to end of study)|All treated participants in Period C evaluated for a specific analyte.|||participants|||Number
2848192|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period B (Day 113 to Day 282)|All treated participants in Period B evaluated for a specific analyte.|||participants|||Number
2848201|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period B (Day 113 to Day 282)|All treated participants in Periods B|||participants|||Number
2848193|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, >=4;Urine Glucose, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period A (Day 1 to Day 113)|All treated participants in Period C evaluated for a specific analyte.|||participants|||Number
2848194|NCT00095173|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate|The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.|Day 113, Day 282, and Day 2047|All treated participants|||percentage of participants||95% Confidence Interval|Number
2848195|NCT00095173|Secondary|Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period C (Day 282 up to 56 days after the last dose of study medication)|All treated participants in Period C|||participants|||Number
2848196|NCT00095173|Secondary|Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period B (Day 113 to Day 282)|All treated participants in Period B|||participants|||Number
2848197|NCT00095173|Secondary|Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period A (Day 1 to Day 113)|All treated participants in Period A|||participants|||Number
2848198|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period C (Day 282 to end of study)|All treated participants in Period C|||percentage change from baseline||Inter-Quartile Range|Median
2848199|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period B (Day 113 to Day 282)|All treated participants in Period B|||percentage change from baseline||Inter-Quartile Range|Median
2848200|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).|Period C (Day 282 to end of study)|All treated participants in Period C|||participants|||Number
2848202|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period A (Day 1 to Day 113)|All treated participants in Periods A|||participants|||Number
2848203|NCT00095173|Secondary|Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)|"All of the following criteria must be met to be defined as a flare:~> 30% worsening in at least 3 of the 6 JRA/JIA core response variables~> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables~≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare~worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants|||participants|||Number
2848204|NCT00095173|Primary|Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)|"Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed.~All of the following criteria must be met to be defined as a flare:~> 30% worsening in at least 3 of the 6 JRA/JIA core response variables~> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables~≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare~worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants|||months||Full Range|Median
2848205|NCT00095147|Primary|OL; Mean Temperature (T) During Open Label Period|Temperature (T), units=degrees Celcius|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.|||degrees Celsius||Standard Deviation|Mean
2848206|NCT00095147|Primary|OL; Mean Heart Rate (HR) During Open Label Period|Heart Rate (HR), units=beats per minute (bpm)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.|||beats per minute (bpm)||Standard Deviation|Mean
2848207|NCT00095147|Primary|OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.|||mm mercury (Hg)||Standard Deviation|Mean
2848208|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
2848209|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
2848210|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
2848211|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
2848212|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
2848415|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population|||hours||Full Range|Median
2848214|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
2848215|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
2848216|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
2848217|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
2848218|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
2848219|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
2848220|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
2848221|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of red blood cells||Standard Error|Mean
2848222|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
2848223|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
2848224|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
2848225|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
2848432|NCT00094770|Secondary|Number of Participants With Drug-related LAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848226|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
2848227|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
2848228|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
2848229|NCT00095147|Secondary|OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 1 (Baseline), Day 729|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.|||units on a scale||Standard Error|Mean
2848230|NCT00095147|Secondary|OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.|||percentage of participants|||Number
2848231|NCT00095147|Secondary|OL; Percentage of Participants Who Achieved Major Clinical Response|Major Clinical Response was defined as a continuous ACR 70 for six months.|Defined from the date of achieving ACR 70 response to 6 months post response|Protocol-specified analyses of the proportion of participants achieving a Major Clinical Response were not performed since ACR responses in the open-label period could only be assessed at 6-month intervals due to the fact that CRP and ESR were only measured every 6 months during this period.||||||
2848232|NCT00095147|Secondary|OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197, Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of participants|||Number
2848233|NCT00095147|Secondary|OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute >5.1 or <0.6 change from BL)|DB Days 365, 533, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.|||percentage of participants|||Number
2848234|NCT00095147|Secondary|OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Efficacy data was summarized for the 3 DB treatment cohorts.n=number of participants with data available.|||percentage of participants|||Number
2848482|NCT00094497|Secondary|Progression-free Survival||every 8 weeks until progression or death up to 5 years||||months||95% Confidence Interval|Median
2848235|NCT00095147|Secondary|OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.|||units on a scale||Standard Error|Mean
2848236|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage of red blood cells||Standard Error|Mean
2848237|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
2848238|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
2848239|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||U/L||Standard Error|Mean
2848240|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mg/dL||Standard Error|Mean
2848241|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||mEq/L||Standard Error|Mean
2848242|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^6 c/uL||Standard Error|Mean
2848243|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^3 c/uL||Standard Error|Mean
2848244|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||percentage red blood cells||Standard Error|Mean
2848245|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||10^9 c/L||Standard Error|Mean
2848246|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.|||g/dL||Standard Error|Mean
2848428|NCT00094809|Secondary|Febrile Neutropenia|Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC < 1.0 x 10^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848247|NCT00095147|Secondary|DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365|Infliximab levels were measured using a microplate enzyme-linked immunosorbant assay (ELISA) with infliximab bound to immobilized recombinant tumor necrosis factor (TNF)-alpha. Bound infliximab is detected utilizing a horseradish peroxidase-conjugated anti-human IgG Fc(fragment, crystallizable region)-specific). The enzyme turns over the substrate O-phenlenediamine to a chromogenic product that is measured at 490 nm. The cut-off value was 1.40 ug/mL; this was based on the mean (+ 3 SD) value in serum samples from 40 participants who had never received infliximab.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of infliximab and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.|||percentage of participants|||Number
2848248|NCT00095147|Secondary|DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)|ECL screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of abatacept and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.|||participants|||Number
2848249|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848250|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848251|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365|Temperature (T) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|As Treated Population.|||participants|||Number
2848252|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365|Heart Rate (HR) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As Treated Population.|||participants|||Number
2848253|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As-Treated Population|||participants|||Number
2848254|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848255|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848429|NCT00094809|Secondary|Dose Delay or Reduction for Any Reason|Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848256|NCT00095147|Primary|OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
2848257|NCT00095147|Primary|OL; Number of Participants With Select Hematologic Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; monocytes: >2000 mm3; eosinophils: >0.750 x 10^3 c/uL;|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
2848258|NCT00095147|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
2848259|NCT00095147|Primary|OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.|||participants|||Number
2848260|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848261|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848262|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848263|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.|||participants|||Number
2848264|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
2848265|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
2848266|NCT00095147|Secondary|DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL)|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
2848267|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 12 months (Day 365)|ITT Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis. SF-36 component scores were not presented in tabular form.|||units on a scale||Standard Error|Mean
2848268|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 6 months (Day 197)|ITT population, all participants randomized into the study receiving study medication. Participants grouped according to the treatment to which they were randomized. All randomized participants who never received study medication were excluded. SF-36 component scores were not presented in tabular form.|||units on a scale||Standard Error|Mean
2848269|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 12 months (Day 365)|Intent-to-Treat (ITT) Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. All participants randomized but never receiving study medication excluded. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis.|||units on a scale||Standard Error|Mean
2848270|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Error|Mean
2848271|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
2848272|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||percentage of participants|||Number
2848273|NCT00095147|Secondary|DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Clinically significant response= decrease in DAS28 score of >1.2 from baseline. DAS28 AUC can be calculated from the DAS28 score versus time curve, which provides an assessment of changes in disease activity over time.|From Day 1 through Day 365 (12 months)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Deviation|Mean
2848274|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Error|Mean
2848275|NCT00095147|Primary|DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.|||units on a scale||Standard Error|Mean
2848276|NCT00095121|Secondary|Percentage of Participants With Durable HBeAg Seroconversion|A participant was defined to have durable HBeAg seroconversion only if she/he remained in a seroconverted state (HBeAg−, hepatitis B e antibody + [anti-HBe+]) from the date that she/he first seroconverted through and including her/his last study visit. This endpoint could only be assessed for participants who (HBeAg−) seroconverted on-treatment and subsequently discontinued open-label dosing.|240 weeks|Participants who discontinued treatment because of confirmed HBeAg seroconversion in Weeks 49 to 240 were to remain in the study through Week 240 to monitor the durability of seroconversion. Any participant who formally stopped drug early and restarted, by definition, did not have durable HBeAg seroconversion.|||Percentage of participants|||Number
2848277|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy|Resistance surveillance was conducted at Week 240/last on-treatment study visit for all participants who had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR while on combination ADV + lamivudine treatment.|240 weeks|32/173 added lamivudine from Weeks 108 - 144. Last on-ADV sample through Week 240 analyzed; participant omitted from cumulative Week 240 analysis if HBV DNA <169 copies/mL at Week 240/last time point or stopped study drug but remained in study. 2 ADV-ADV participants had ADV/lamivudine-specific, conserved-site mutation, and counted 2x in table.|||Participants|||Number
2848287|NCT00095121|Secondary|ADV Baseline ALT|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||U/L||Standard Deviation|Mean
2848278|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)|Resistance surveillance was conducted annually for all participants who remained on treatment and had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR. The last on-ADV sample for all participants in the study was analyzed in the cumulative Week 240 resistance surveillance analysis.|240 weeks|Last on-ADV sample through Week 240 was analyzed, and participant was excluded from the cumulative Week 240 analysis if HBV DNA value was < 169 copies/mL at Week 240/last time point or if participant discontinued study drug but remained in study. One ADV-ADV participant had an ADV-specific, conserved-site mutation and is counted twice in the table.|||Participants|||Number
2848279|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|Per protocol, participants could discontinue study medication due to HBeAg seroconversion and remain in the study in order to evaluate the durability of seroconversion. HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
2848280|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|ADV baseline = 1st ADV-dose day = Week 0 for ADV-ADV group and Week 48 for PLB-ADV group. ADV week = windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). HBeAg loss is defined per individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
2848281|NCT00095121|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)|HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and hepatitis B e antibody + (anti-HBe+) post baseline.|Study Week 0 to Study Week 48 (double-blind period)|The randomized and treated analysis set included all participants who were randomized into the study and received at least one dose of study medication. For Week 48 data; if Week 48 was missing, Week 44 was carried forward; if Week 44 was missing, missing = failure.|||percentage of participants|||Number
2848282|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)|Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
2848283|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
2848284|NCT00095121|Secondary|Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.|||percentage of participants|||Number
2848285|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for ALT||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||U/L||Standard Deviation|Mean
2848286|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for ALT|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||U/L||Standard Deviation|Mean
2848288|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for Serum HBV DNA||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||log10 HBV DNA copies/mL||Standard Deviation|Mean
2848289|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for Serum HBV DNA|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||log10 HBV DNA copies/mL||Standard Deviation|Mean
2848290|NCT00095121|Secondary|Adefovir (ADV) Baseline Serum HBV DNA|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.|||log10 HBV DNA copies/mL||Standard Deviation|Mean
2848291|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
2848292|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
2848293|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
2848294|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
2848295|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
2848296|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.|||percentage of participants|||Number
2848297|NCT00095121|Primary|Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)|In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.|Week 48|All randomized participants who received >= 1 dose study medication. If either endpoint was missing a Week 48 value, Week 44 value was substituted and used in the combined endpoint. If participant did not have serum HBV DNA value at Weeks 44 and 48 or ALT value at Weeks 44 and 48, then participant was considered a failure for the Week-48 analysis.|||percentage of participants|||Number
2848298|NCT00095056|Secondary|Safety and Tolerability of Sitagliptin Over 54 Weeks|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 54|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.|||Participants|||Number
2848299|NCT00095056|Primary|Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 12|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.|||Participants|||Number
2848300|NCT00094900|Secondary|Mean Change in Prednisone Dose||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mg/day||Standard Error|Mean
2848304|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
2848305|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
2848306|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
2848307|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||swollen joints||Standard Error|Mean
2848308|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
2848309|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
2848310|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
2848311|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||tender joints||Standard Error|Mean
2848312|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
2848313|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
2848314|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
2848315|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||units on a scale||Standard Error|Mean
2848316|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
2848317|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
2848318|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||mm/hour||Standard Error|Mean
2848336|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848337|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848338|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848339|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848340|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848341|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848342|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0-100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473-83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848343|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848344|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848345|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848346|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848347|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848348|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Deviation|Mean
2848349|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0-100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848350|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848351|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848352|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848353|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848354|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848355|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848356|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||swollen joints||Standard Error|Mean
2848357|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848358|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848359|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848360|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848483|NCT00094497|Primary|Overall Survival|participants who died among those randomized to first-line therapy|every 8 weeks until death up to 5 years||||participants|||Number
2848361|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848362|NCT00094900|Secondary|Mean Change in Tender Joint Count.|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848363|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||tender joints||Standard Error|Mean
2848364|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848365|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848366|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848367|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848368|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848369|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848370|NCT00094900|Secondary|Mean Change in Patient's Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848371|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848372|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848373|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848374|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848375|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848376|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848377|NCT00094900|Secondary|Mean Change in Patient's Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848378|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848379|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848380|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848381|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848382|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848383|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848384|NCT00094900|Secondary|Mean Change in Physician's Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848385|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848386|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848387|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848388|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848389|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848390|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848391|NCT00094900|Secondary|Mean Change in Patient's Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0-10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848392|NCT00094900|Primary|Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease|At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)|||participants|||Number
2848393|NCT00094900|Primary|Mean Change in SAA|SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||mg/liter||Standard Error|Mean
2848394|NCT00094900|Primary|Mean Change in hsCRP|hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||mg/dl||Standard Error|Mean
2848395|NCT00094900|Primary|Mean Change in ESR|ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||mm/hour||Standard Error|Mean
2848396|NCT00094900|Primary|Mean Change in Daily Scores|Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 [no symptom] to 4 [worst symptom], with an overall range score of 0-12).|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)|||units on a scale||Standard Error|Mean
2848397|NCT00094887|Secondary|Number of Participants Readmitted to Hospital Within 30 Days After Discharge|The number of participants readmitted to the hospital for any reason within 30 days after discharge|during first 24 hours and during 30 day follow-up|Intention to treat|||Participants|||Count of Participants
2848398|NCT00094887|Secondary|Number of Participants With Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion|Number of participants who required a blood transfusion before discharge because of acute chest syndrome/pneumonia|within 40 days|Intention to treat|||Participants|||Count of Participants
2848399|NCT00094887|Secondary|Total Dose of Opioids Received|The total dose (mg) of opioid medications received during the trial|within 8 hours and within 40 days|Intention to treat|||mg||Full Range|Median
2848400|NCT00094887|Secondary|Number of Participants Discharged to Home Within the First 24 Hours||within 24 hours|Intention to treat|||Participants|||Count of Participants
2848401|NCT00094887|Secondary|Length of Hospitalization|Length of hospitalization is defined as the length of time from admission to discharge order|within 40 days|Intention to treat|||Days||Full Range|Median
2848402|NCT00094887|Primary|Time to Vaso-occlusive Pain Crisis (VOC) Resolution|"VOC resolution was defined by all of the following conditions:~Pain relief - Visual Analog Scale (VAS) pain scores of 6 or less, (6 as worst and 0 as best)~Freedom from parenteral narcotic use,~Ability to walk unless the subject was not able to walk for any reason other than acute VOC prior to the onset of crisis,~Subject and/or family's belief that the painful crisis could be managed at home with or without oral analgesic use, and the physician concurred with that assessment."|within 30 days|Primary efficacy analysis set, defined as intent to treat population with VOC resolution|||Hours||Full Range|Median
2848403|NCT00094861|Secondary|Maximal Body Weight Loss|Maximal weight loss observed from Baseline through to Week 12.|Baseline through Week 12|Full analysis set with available data|||kilograms||Standard Deviation|Mean
2848404|NCT00094861|Secondary|Number of Participants Hospitalized||Baseline to Week 16|Full analysis set|||participants|||Number
2848405|NCT00094861|Secondary|Maximal Eastern Cooperative Oncology Group (ECOG) Performance Status Increase|"Maximal increase from Baseline in Eastern Cooperative Oncology Group (ECOG) performance status. ECOG is a scale to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.~Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead."|Baseline through Week 12|Full analysis set participants with available ECOG data|||units on a scale||Standard Deviation|Mean
2848406|NCT00094861|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|The number of participants with unplanned breaks in radiotherapy of ≥ 5 days or who discontinued radiotherapy during Week 1 to Week 6.|Week 1 to Week 6|Full analysis set|||participants|||Number
2848407|NCT00094861|Secondary|Number of Participants With Severe (Grade 3 or Higher) Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set|||participants|||Number
2848408|NCT00094861|Secondary|Maximal Dysphagia Grade|"The mean maximal grade of dysphagia for each participant during the study. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set participants with dysphagia assessments.|||grade||Standard Deviation|Mean
2848409|NCT00094861|Secondary|Duration of Grade 2 or Higher Dysphagia|"Duration of grade 2 or higher dysphagia was calculated in days from the onset (first occurrence of grade ≥ 2) to the resolution (grade ≤ 1 after the last grade ≥ 2) of dysphagia.~Participants with no assessments were assumed as having grade ≥ 2 dysphagia and with a duration of the mean duration of all participants."|Start of treatment through Week 16|Full analysis set|||days||Standard Deviation|Mean
2848410|NCT00094861|Primary|Number of Participants With Grade 2 or Higher Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set|||participants|||Number
2848411|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 2, Day 1, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.|||ng/mL||Standard Deviation|Mean
2848412|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2|Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.|||μg*hr/mL||Standard Deviation|Mean
2848413|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for three treatment groups for which the sample size was smaller than 3.|||hours||Standard Deviation|Mean
2848414|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2|The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population|||ng/mL||Standard Deviation|Mean
2848430|NCT00094809|Secondary|Dose Delay or Reduction Due to Neutropenia|Dose delay or reduction in chemotherapy doses due to neutropenia|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848416|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 1, Day 3, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.|||ng/mL||Standard Deviation|Mean
2848417|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1|Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.|||μg*hr/mL||Standard Deviation|Mean
2848418|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.|||hours||Standard Deviation|Mean
2848419|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1|The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population|||ng/mL||Standard Deviation|Mean
2848420|NCT00094835|Secondary|Percentage of Participants With an Overall Objective Response|Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions.|After 9 weeks of treatment (at the end of Cycle 3)|Efficacy analysis set, composed of all enrolled participants who received at least one dose of motesanib in treatment arms 1-3 or at least one dose of motesanib with one dose of panitumumab in treatmnt arms 4-7.|||Percentage of participants|||Number
2848421|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing.|||hours||Full Range|Median
2848422|NCT00094809|Primary|Grade 4 Neutropenia|Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) <0.5 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848423|NCT00094809|Secondary|Antibiotic Use Due to Febrile Neutropenia|Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848424|NCT00094809|Secondary|Survival|Death from any cause through the end of the follow-up period|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures.|||Participants|||Number
2848425|NCT00094809|Secondary|Objective Tumor Response|Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848426|NCT00094809|Secondary|Progression-Free Survival|Kaplan-Meier estimate of the median time to disease progression or death|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Days||95% Confidence Interval|Median
2848427|NCT00094809|Secondary|Hospitalization Due to a Neutropenia-Related Event|Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment|First 4 cycles of neutropenia (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848431|NCT00094809|Primary|Grade 3 or 4 Neutropenia|Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) < 1 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures|||Participants|||Number
2848433|NCT00094770|Secondary|Number of Participants With Serious LAEs at Week 104|Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848434|NCT00094770|Secondary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848435|NCT00094770|Secondary|Number of Participants With Drug-related CAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848436|NCT00094770|Secondary|Number of Participants With Serious CAEs at Week 104|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848437|NCT00094770|Secondary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848438|NCT00094770|Secondary|Hypoglycemic Events at Week 104|Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848439|NCT00094770|Secondary|Hypoglycemic Events at Week 52|Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.|Baseline to Week 52|All randomized participants who received at least 1 dose of the double-blind study therapy.|||Participants|||Number
2848440|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Baseline and Week 104|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.|||Kilograms||95% Confidence Interval|Least Squares Mean
2848441|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 52|Change from baseline at Week 52 is defined as Week 52 minus Week 0.|Baseline and Week 52|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.|||Kilograms||95% Confidence Interval|Least Squares Mean
2848442|NCT00094770|Secondary|Change From Baseline in HbA1c at Week 104|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 104|The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.|||Percent||95% Confidence Interval|Least Squares Mean
2848443|NCT00094770|Primary|Change From Baseline in HbA1c at Week 52|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 52|The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.|||Percent||95% Confidence Interval|Least Squares Mean
2848444|NCT00094757|Secondary|Change From Baseline in FPG at Week 54|The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.|||mg/dL||95% Confidence Interval|Least Squares Mean
2848445|NCT00094757|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.|||percent||95% Confidence Interval|Least Squares Mean
2848446|NCT00094757|Secondary|Change From Baseline in FPG at Week 18|The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Weeks 0-18|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing.|||mg/dL||95% Confidence Interval|Least Squares Mean
2848447|NCT00094757|Primary|Change From Baseline in A1C at Week 18|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Weeks 0-18|All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.|||percent||95% Confidence Interval|Least Squares Mean
2848891|NCT00090545|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of BAY 43-9006 (Sorafenib)|Time to maximum concentration for sorafenib.|0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose||||hours||Full Range|Median
2848448|NCT00094653|Secondary|Clinically Meaningful Changes in Vital Signs and Physical Examinations|Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.|vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter|All subjects who received at least 1 dose or any partial dose of study medication.|||participants|||Number
2848449|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Renal Abnormalities|CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.|||percentage of participants|||Number
2848450|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Liver Abnormalities|ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.|||percentage of participants|||Number
2848451|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Hematological Abnormalities|ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.|||percentage of participants|||Number
2848452|NCT00094653|Secondary|Percentage of Participants With Immune-Related Adverse Events (irAEs)|"An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of Other irAEs includes blood, eye, immune, infections, renal, and respiratory systems."|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.|||percentage of participants|||Number
2848453|NCT00094653|Secondary|Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death|An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.|||percentage of participants|||Number
2848454|NCT00094653|Secondary|Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12|The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).|Baseline (Day 1, Cycle1), Week 12|All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.|||units on a scale||95% Confidence Interval|Least Squares Mean
2848455|NCT00094653|Secondary|Delayed Response (Response Beyond Week 24)|Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed.|from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Number of subjects with BOR of PR/SD (80 subjects ipi + gp100 , 37 ipi , 15 gp100) plus number of subjects with BOR of PD that had subsequent evaluation (8 ipi + gp100, 3 ipi, 3 gp100).|||participants|||Number
2848456|NCT00094653|Secondary|Disease Control Rate (DCR)|Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
2848484|NCT00094458|Secondary|Average Corticosteroid Use|Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants taking corticosteroids for Crohn’s disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively.|||milligram per day||Standard Deviation|Mean
2848457|NCT00094653|Secondary|Duration of Response|Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).|from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment.|||months||95% Confidence Interval|Median
2848458|NCT00094653|Secondary|Time to Response|Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||Full Range|Mean
2848459|NCT00094653|Secondary|Determination of Best Overall Response Rate (BORR)|Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
2848460|NCT00094653|Secondary|Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)|Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion.|BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||participants|||Number
2848461|NCT00094653|Secondary|Time to Progression (TTP)|TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.|from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
2848462|NCT00094653|Secondary|Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24|PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|Week 12, Week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Median
2848463|NCT00094653|Secondary|Progression Free Survival (PFS)|PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment.|||months||95% Confidence Interval|Median
2848464|NCT00094653|Secondary|12-, 18-, and 24-Month Survival Rates|The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.|Month 12, Month 18, Month 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||probability||95% Confidence Interval|Number
2848465|NCT00094653|Secondary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
2848466|NCT00094653|Primary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
2848892|NCT00090545|Secondary|Geometric Mean for Exposure Area Under the Curve (AUC) 0-12|Geometric mean exposure for sorafenib.|0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, and 24 hours post-dose||||mg/L.h||95% Confidence Interval|Geometric Mean
2848467|NCT00094575|Secondary|International Index of Erectile Function (IIEF-5)|"Change (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function.~Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
2848468|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale|"Change (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
2848469|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Index Score|"Change (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0.~Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
2848470|NCT00094575|Secondary|SF-36 Physical Component Deaths Included Score (PCTD)|"Change (over time) since baseline in Physical Component Deaths included Score of SF-36.~The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
2848471|NCT00094575|Secondary|SF-36 Physical Component Score (PCS)|"Change (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
2848472|NCT00094575|Secondary|SF-36 Mental Component Score (MCS)|"Change (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and then yearly, up to 9 years||||units on a scale||95% Confidence Interval|Least Squares Mean
2848473|NCT00094575|Secondary|Secondary Therapeutic Procedures|This outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.|Participants were followed for the duration of the study, up to 9 years||||participants|||Number
2848474|NCT00094575|Primary|All-cause Mortality|Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].|Participants were followed for the duration of the study, up to 9 years||||participants|||Number
2848475|NCT00094536|Primary|Success (Reduction in Menstruation to Normal Levels)|Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.|1 Year|Intention-to-Treat Analysis|||Participants|||Count of Participants
2848476|NCT00094497|Other Pre-specified|Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate||every 8 weeks until progression or until Dec 2010|||||||
2848477|NCT00094497|Other Pre-specified|Pharmakinetics of Mitotane (Substudy)|To study the relationship between mitotane dose (daily and cumulative) and mitotane plasma concentrations using one of two pre-defined treatment regimens (high-dose and low-dose).|11 time points in the first 12 weeks|||||||
2848478|NCT00094497|Other Pre-specified|TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime||every 8 weeks until progression or until Dec 2010|||||||
2848479|NCT00094497|Secondary|Number of Disease-free Patients|complete response or disease-free by time of surgery|every 8 weeks until progression (up to 5 years)||||participants|||Number
2848480|NCT00094497|Secondary|Best Overall Response Rate|RECIST 1.0 was used to evaluate response|every 8 weeks up to 5 years||||participants|||Number
2848481|NCT00094497|Secondary|Change in Quality of Life as Measured by QLQ-C30|scale ranged from 0 to 100 with higher score meaning greater quality of life|baseline and 8 weeks|participants with data on both time points|||units on a scale||Standard Deviation|Mean
2848485|NCT00094458|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)|Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).|Baseline and Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively.|||units on a scale||Standard Deviation|Mean
2848486|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Study Extension)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 34, 42, 50|Population analyzed included all randomized participants during the Study Extension.|||percentage of participants|||Number
2848487|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Main Study)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants during the Main Study.|||percentage of participants|||Number
2848488|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Study Extension)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 34, 42 and 50|Population analyzed included all randomized participants enrolled in the Study Extension.|||percentage of participants|||Number
2848489|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Main Study)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants enrolled in the main study.|||percentage of participants|||Number
2848490|NCT00094458|Secondary|Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 50|Population analyzed included all randomized participants enrolled in Study Extension.|||percentage of participants|||Number
2848491|NCT00094458|Secondary|Percentage of Participants With Mucosal Healing|Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.|Week 26|Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, ‘N’ [number of participants analyzed] signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2848492|NCT00094458|Primary|Percentage of Participants With Corticosteriod-free Clinical Remission|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 26|Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.|||percentage of participants|||Number
2848493|NCT00094328|Secondary|Change in Average Testicular Volume|Testicular volume of both testes was measured using either ultrasound or an orchidometer. Testicular volume was measured at baseline and at 6 and 12 months. The change in testicular volume from baseline was calculated for the left and right testicle as well as the average across both testes by subtracting the baseline volume from the volumes at 6 and 12 months within each patient.|Assessed after 6 and 12 months of treatment|All treated (AT) set|||mL||Standard Deviation|Mean
2848494|NCT00094328|Secondary|Change in Predicted Adult Height (PAH)|Radiographs are used to assess the bone age, the change in predicted adult height (PAH) is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH is be calculated by subtracting the PAH at baseline from the PAH at 12 months.|Assessed after 12 months treatment|Calculated on All treated analysis set, however, if bone age is less than 6 years or bone age is less than 7 years and bone age>=(chronological age-1) then PAH cannot be calculated using the Bayley and Pinneau method.|||cm||Standard Deviation|Mean
2848495|NCT00094328|Secondary|Number of Patients With Height Between 5th and 95th Percentile|The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.|Assessed after 3, 6, 9 and 12 months of treatment|All treated (AT) set|||Participants|||Number
2848496|NCT00094328|Secondary|Change in Bone Age to Chronological Age Ratio|Change in bone age to chronological age ratio after 6 and 12 months treatment relative to the baseline ratio for all patients.|Assessed after 6 and 12 months of treatment|All treated (AT) set|||Ratio||Standard Deviation|Mean
2848497|NCT00094328|Secondary|Change in Bone Age Maturation Rate (cm/Year)|Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation after 6 months of treatment was calculated relative to the rate of change in bone age during the ≥ 6 months pre-study period.|Assessed after 6 and 12 months treatment|Calculated on All treated analysis set for those patients who had a 6-month pre study radiograph.|||cm/year||Standard Deviation|Mean
2848498|NCT00094328|Secondary|Change in Growth Rate (SD Units)|Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.|Assessed after 6 months treatment|All treated (AT) set|||SD units||Standard Deviation|Mean
2848499|NCT00094328|Secondary|Change in Growth Rate (cm/Year)|Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.|Assessed after 6 months treatment|All treated (AT) set|||cm/year||Standard Deviation|Mean
2848500|NCT00094328|Primary|Change in Growth Rate (SD Units)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).|Assessed after 12 months treatment|All treated (AT) set|||SD units||Standard Deviation|Mean
2848502|NCT00094302|Secondary|Estimated Glomerular Filtration Rate (GFR)|Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mL/min/1.73m2||Standard Error|Least Squares Mean
2848503|NCT00094302|Secondary|Chloride|Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mEq/L||Standard Error|Least Squares Mean
2848504|NCT00094302|Secondary|Sodium|Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mEq/L||Standard Error|Least Squares Mean
2848505|NCT00094302|Secondary|Serum Creatinine|Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mg/dL||Standard Error|Least Squares Mean
2848506|NCT00094302|Secondary|Potassium|Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||mEq/L||Standard Error|Least Squares Mean
2848507|NCT00094302|Secondary|Hospitalization for Any Reason|First incidence of a hospitalization for any reason|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848508|NCT00094302|Secondary|Depression Symptoms, as Measured by Patient Health Questionnaire.|"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
2848509|NCT00094302|Secondary|Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.~The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
2848510|NCT00094302|Secondary|Quality of Life, as Measured by the EuroQOL Visual Analog Scale.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
2848825|NCT00090857|Secondary|Worst Grade Nausea|Participants reported worst grade nausea grade 01: able to eat, 02: oral intake significantly decreased, 03: no significant intake, requiring IV fluids during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
2848511|NCT00094302|Secondary|Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||units on a scale||Standard Error|Least Squares Mean
2848512|NCT00094302|Secondary|Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848513|NCT00094302|Secondary|Deterioration of Renal Function|First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848514|NCT00094302|Secondary|Stroke|First incidence of stroke|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848515|NCT00094302|Secondary|Myocardial Infarction|First incidence of myocardial infarction|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848516|NCT00094302|Secondary|Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.|First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848517|NCT00094302|Secondary|New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.|First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848518|NCT00094302|Secondary|Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848519|NCT00094302|Secondary|Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848520|NCT00094302|Secondary|Cardiovascular-related Hospitalization|Hospitalization for MI, stroke or the management of heart failure, whichever occurred first|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848521|NCT00094302|Secondary|Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848522|NCT00094302|Secondary|All-cause Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848893|NCT00090545|Secondary|Maximum Observed Plasma Concentration (Cmax) of BAY 43-9006 (Sorafenib)|Plasma concentration-time profile for sorafenib.|0, 0.25, 0.50, 1, 2, 4, 6, 8, 12, AND 24 hours post dose||||mg/L||Full Range|Mean
2848523|NCT00094302|Secondary|Hospitalization for the Management of Heart Failure|First incidence of a hospitalization for the management of heart failure|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848524|NCT00094302|Secondary|Aborted Cardiac Arrest|First incidence of aborted cardiac arrest|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848525|NCT00094302|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848526|NCT00094302|Primary|Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.|||Events per 100 person-years|||Number
2848527|NCT00094211|Primary|Neighborhood Environment for Walkability Survey (NEWS) - Land Use Mix Access|The scale is land use mix access which is a mean of 7 items. The minimum value is 1 and the maximum value is 4. Higher scores indicate easier access to services which is indicative of a high walkability environment (i.e., a better outcome).|Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.||||units on a scale||Standard Deviation|Mean
2848528|NCT00094211|Primary|Neighborhood Environment for Walkability Survey (NEWS) - Walking and Cycling Facilities in Neighborhood|The scale is walking/cycling facilities which is a mean of 5 items. The minimum value is 1 and the maximum value is 4. Higher scores indicate an environment that is supportive of walking and cycling which is a better outcome.|Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.||||units on a scale||Standard Deviation|Mean
2848529|NCT00094211|Primary|Accelerometer Measured Physical Activity|Ambulatory assessment of moderate-to-vigorous physical activity using a validated Actigraph accelerometer. Participants were instructed to wear the accelerometer during waking hours for seven days at each of the two measurement points. The accelerometer was placed over the right hip. Data were cleaned and scored using MeterPlus version 4.0 software.|Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.||||minutes per day||Standard Deviation|Mean
2848530|NCT00094211|Primary|Community Healthy Activities Model Program for Seniors (CHAMPS) Self-reported Walking for Errands|A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable. (See Stewart AL, Mills KM, King AC, et al. CHAMPS Physical Activity Questionnaire for Older Adults: Outcomes for Interventions. Med Sci Sports Exerc, 33:7, 1126-1141, 2001.)|Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.||||minutes per week||Standard Deviation|Mean
2848531|NCT00094211|Primary|Physical Environment Factors Using Geographic Information Systems [GIS]|Physical environment factors measured using GIS-derived measures of street connectivity, residential density, and mixed land use in participant block groups and a network buffer around each participant's home. A walkability index was created for a 500 meter street network buffer around participant homes. The walkability index was calculated for each census block group in the regions by summing the z-scores of four macro built environment measures: 1) net residential density, 2) intersection density, 3) retail floor to land area ratio (FAR), and 4) mixed use. A higher scores indicates higher walkability. The minimum value is -4.08 and the maximum value is 12.5.|at two time points, 6 months apart, which were averaged|GIS variables were created for all participants enrolled in the study|||units on a scale||Standard Deviation|Mean
2848532|NCT00094172|Secondary|Proportion of Participants Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]~The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS~Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|18 months post-randomization|Intent-to-Treat|||Participants|||Number
2848533|NCT00094172|Secondary|Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]~The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS~Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|12 months post-randomization|Intent-to-Treat|||Participants|||Number
2848826|NCT00090857|Secondary|Worst Grade Muscle Aches/Pains|Participants reported worst grade muscle aches/pains defined as grade 01: mild, 02: moderate, 03: severe (CTCAEv3) or 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
2848534|NCT00094172|Primary|The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.|"The occurrence of ≥ T2 lesions[1] with or without gadolinium lesion (Gd+) enhancement[2] or clinical exacerbation[3] through 12 months. A higher score indicates more severe disease~A new T2 lesion is an abnormal, hyperintense white-matter area visible on T2 weighted images that were not present on the baseline scan~A Gd+ enhancement is defined as a contrast enhancement visible on a new T2 lesion~A clinical exacerbation is a new neurological symptom that lasts more than 48 hours in a participant who has been neurologically stable for 30 days following start of study medication"|12 months post-randomization|Intent-to-Treat|||Participants|||Number
2848535|NCT00094107|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 147 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||Ratio||Standard Deviation|Mean
2848536|NCT00094107|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 147 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.|||ng/mL||Standard Deviation|Mean
2848537|NCT00094107|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2848538|NCT00094107|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
2848539|NCT00094107|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.|||Days||95% Confidence Interval|Median
2848540|NCT00094107|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
2848541|NCT00094094|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 98 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||Ratio||Standard Deviation|Mean
2848551|NCT00094055|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks|ITT population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2848542|NCT00094094|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 98 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2848543|NCT00094094|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who enrolled and received treatment.|||Days||95% Confidence Interval|Median
2848544|NCT00094094|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
2848545|NCT00094094|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.|||Days||95% Confidence Interval|Median
2848546|NCT00094094|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.|||Percentage of participants||95% Confidence Interval|Number
2848547|NCT00094055|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 206 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.|||Ratio||Standard Deviation|Mean
2848548|NCT00094055|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2848549|NCT00094055|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|ITT population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2848550|NCT00094055|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks|Subgroup of participants from the ITT population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
2848552|NCT00094055|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2848553|NCT00093964|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a subject which did not necessarily have a causal relationship with the study drug. A TEAE was any AE that started on or any time after the day of first dose of cilengitide during the treatment phase or within the safety follow-up after last dose of cilengitide. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly.|From the start of treatment up to 6 years|The safety population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.|||subjects|||Number
2848554|NCT00093964|Secondary|Apparent Volume of Distribution at Steady State (Vss)|Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state.|Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2|"The PK population included the subjects who had received cilengitide and who had blood samples drawn in Week 1 and/or 5 that provided drug concentration for non-compartmental PK evaluation. Here, Number of participants analysed signifies those subjects who were evaluable for this outcome measure."|||Liter (L)||Standard Deviation|Mean
2848555|NCT00093964|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz)|Vz was calculated as Dose/(AUC0-infinity multiplied by elimination rate constant [lambda z]) following single dose.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The PK population included the subjects who had received cilengitide and who had had blood samples drawn in Week 1 and/or 5 that provided drug concentration for non-compartmental PK evaluation. Here, Number of participants analysed signifies those subjects who were evaluable for this outcome measure."|||Liter (L)||Standard Deviation|Mean
2848556|NCT00093964|Secondary|Total Body Clearance (CL) of Drug From Plasma/Cerebro Spinal Fluid (CSF)|CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose divided by AUC0-infinity.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The pharmacokinetic (PK) population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||Liter per hour (L/h)||Standard Deviation|Mean
2848557|NCT00093964|Secondary|Mean Residence Time of Drug in the Body (MRT)|MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The pharmacokinetic (PK) population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||Hour (h)||Standard Deviation|Mean
2848558|NCT00093964|Secondary|Terminal Half-life (t1/2)|The t1/2 is the time taken to eliminate half the amount of cilengitide.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||Hour (h)||Full Range|Median
2848559|NCT00093964|Secondary|Apparent Terminal Rate Constant (Lambda z)|Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||Per hour (/h)||Standard Deviation|Mean
2848560|NCT00093964|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Administration (AUC 0-infinity)|AUC 0-infinity is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration of cilengitide.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||Microgram per milliliter*hour (mcg/mL*h)||Standard Deviation|Mean
2848561|NCT00093964|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax is the time to reach the maximum plasma concentration (Cmax) of cilengitide.|Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2|"The PK population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||Hour (h)||Full Range|Median
2848827|NCT00090857|Secondary|Worst Grade Hot Flashes|Participants reported worst grade hot flashes: 01: mild (<1qd) or 02: moderate (>1qd) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
2848562|NCT00093964|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax is the maximum observed plasma concentration of cilengitide after administration.|Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2|"The pharmacokinetic (PK) population: subjects who had received cilengitide and who had blood samples drawn in Week 1 that provided drug concentration for non-compartmental PK evaluation. Here,Overall Number of participants analyzed“ = subjects evaluable for this outcome and Number analyzed = subjects evaluable for the specified category."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2848563|NCT00093964|Secondary|Percentage of Subjects With 1-year of Survival Rate|1-year survival rate was defined as percentage of subjects who survived for >=365 days with or without disease progression. Disease progression was assessed as per independent central blinded radiology assessment.|From the start of treatment up to 1 year|ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.|||percentage of subjects||95% Confidence Interval|Number
2848564|NCT00093964|Secondary|Overall Survival Time|Survival time was defined as the number of months between the date of randomization and the date of death or the last date the subject was known to be alive.|From the start of treatment until death (assessed up to a maximum of 6 years)|ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.|||months||Full Range|Median
2848565|NCT00093964|Secondary|Time to Disease Progression|Time to disease progression was defined as the number of days between the first dose and the date of first assessment of progressive disease during the study or until death. Surviving subjects without progressive disease were censored at the time of the last visit and the subject was known to be non-progressing. Disease progression was assessed as per independent central blinded radiology assessment.|From the start of treatment until disease progression (assessed up to a maximum of 6 years)|ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide.|||months||Full Range|Median
2848566|NCT00093964|Secondary|Percentage of Subjects With Overall Response Rate|Overall response rate was defined as percentage of subjects who had best response during the study which was either complete response (CR: disappearance of all tumors, no new lesions and stable or improved neurological examination) or partial response (PR: >= reduction in the sum of the products of the largest perpendicular diameters compared to the baseline sum, no worsening of evaluable lesion and stable or improved neurological examination). CR or PR was confirmed within 31 days with a repeat neuroimaging.|From the start of treatment up to 6 years|"ITT population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. Here,Number of participants analysed signifies those subjects who were evaluable for this outcome measure."|||percentage of subjects||95% Confidence Interval|Number
2848567|NCT00093964|Primary|Percentage of Subjects With Progression-free Survival|Progression-free survival was defined as subjects who survived greater than or equal to (>=) 180 days without disease progression. Disease progression was assessed as per independent central blinded radiology assessment.|Month 6|"The intention-to-treat (ITT) population included all randomized subjects who had received at least 1 intravenous administration of cilengitide. Here,Number of participants analyzed“ signifies those subjects who were evaluable for this outcome measure."|||percentage of subjects||95% Confidence Interval|Number
2848568|NCT00093847|Secondary|HDRS17 Responders|35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF|||Percentage of Responders HDRS17|||Number
2848569|NCT00093847|Primary|Hamilton Depression Rating Scale Remission Rates|The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF|||Percentage of Remitters HDRS17|||Number
2848570|NCT00093808|Secondary|Overall Survival as Assessed by Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.|||months||95% Confidence Interval|Median
2848571|NCT00093808|Secondary|Duration of Response as Measured by RECIST Criteria|Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.|||months||95% Confidence Interval|Median
2848572|NCT00093808|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or unequivocal progression of existing non-target lesions.|Up to 5 years|Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.|||months||95% Confidence Interval|Median
2848590|NCT00093756|Secondary|Confirmed Tumor Response|Response was assessed using the RECIST v1.1 criteria. Patients were evaluated at 4 weeks post-RT, 3 months post-RT, every 3 months for 1 year post-RT, and every 6 months thereafter for a maximum of 5 years from time of registration. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart.|Up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||Participants|||Count of Participants
2848573|NCT00093808|Primary|Confirmed Response Rate|A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Patients who completed the study were included in all analyses unless otherwise specified.|||proportion of patients||95% Confidence Interval|Number
2848574|NCT00093795|Secondary|Toxicity|Percentage of patients who ever experienced grade 2 or higher toxicities.|30 days after the last dose of study therapy (about 7 months after study entry)|For Arm 1 there is no follow-up data for 23 participants; for Arm 2 there is no follow-up data for 11 participants; and for Arm 3 there is not follow-up data for 18 participants.|||percentage of patients||95% Confidence Interval|Number
2848575|NCT00093795|Secondary|Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only|Percentage of patients distant recurrence-free (no distant disease recurrence only)|5 years|For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.|||percentage of patients||95% Confidence Interval|Number
2848576|NCT00093795|Secondary|Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence|Percentage of patients recurrence-free (no first local, regional, or distant recurrence)|5 years|For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.|||percentage of patients||95% Confidence Interval|Number
2848577|NCT00093795|Secondary|Overall Survival|Percentage of participants alive at 5 years|5 years|For Arm 1 there is no follow-up data for 13 participants; for Arm 2 there is no follow-up data for 10 participants; and for Arm 3 there is no follow-up data for 12 participants.|||percentage of patients alive||95% Confidence Interval|Number
2848578|NCT00093795|Primary|Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer|The percentage of patients alive and cancer-free.|5 years|For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.|||percentage of patients||95% Confidence Interval|Number
2848579|NCT00093782|Secondary|Time to Progression||Up to 8 years|At the time of publication, 5 patients were still on treatment and analysis was done on 31 patients|||months||95% Confidence Interval|Median
2848580|NCT00093782|Secondary|Number of Temsirolimus Treatment Cycle Analyzed for Toxicity|Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3|Duration of participants treatment upto 16wks (4cycles) of treatment||||treatment cycles|||Number
2848581|NCT00093782|Secondary|Response and Stable Disease|Assessed using RECIST criteria.Patients that had Stable disease for 2 months|2 months|Number of patients that had stable disease for 2 months|||patients|||Number
2848582|NCT00093782|Secondary|Survival Rate|Computed using the Kaplan-Meier method.|1 year|Out of the 25 patients alive as of Jan 2006|||percentage of participants||95% Confidence Interval|Number
2848583|NCT00093782|Secondary|Median Survival Time|Computed using the Kaplan-Meier method.|3|Out of the 25 patients alive (in 2006 at time of publication)|||months||95% Confidence Interval|Median
2848584|NCT00093782|Secondary|Stable Disease Rate Defined by RECIST Criteria|Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 8 years||||participants|||Number
2848585|NCT00093782|Primary|Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 years||||participants|||Number
2848586|NCT00093756|Secondary|Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE)|Toxicity was reported after the first 21 days of treatment and after each 28 day cycle thereafter. Events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. The number of patients reporting grade 3 and higher are tabulated.|Up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||Participants|||Count of Participants
2848587|NCT00093756|Secondary|Overall Survival|Overall Survival is defined as the time from registration to the time to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||months||95% Confidence Interval|Median
2848588|NCT00093756|Secondary|Progression-free Survival|The distribution of progression-free survival (PFS) is defined as the time from registration to the time of progression or death, whichever comes first. The PFS will be estimated using the method of Kaplan-Meier.|From study registration to the first of either death due to any cause or progression, up to 5 years|All 21 patients from Phase II and 6 patients registered to the Phase II dose level of Phase I were included in this analysis.|||months||95% Confidence Interval|Median
2848589|NCT00093756|Secondary|Time to Progression|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From study registration to date of disease progression or date of last follow-up, up to 5 years|Study team decision not to run this analysis.||||||
2849806|NCT00082407|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat|||events per 30 days per patient||Standard Error|Least Squares Mean
2848591|NCT00093756|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only.|The primary endpoint of this trial is the proportion of patients alive at 1 year (i.e., 365 days) after study registration. Proportion of successes, defined as the number of patients alive at one year divided by the total number of evaluable patients.|At 1 year|This analysis included all 21 patients enrolled in the Phase II portion of the study and 6 patients enrolled in the Phase I who were treated at the Phase II dose level.|||proportion of Participants|||Number
2848592|NCT00093496|Secondary|Toxicity|Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for adverse events.|||events|||Number
2848593|NCT00093496|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|Every 3 months until disease progression and then every 6 months for up to 5 years.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical acttivity, the interim analysis for Cohort 2 was conducted on the first 11 participants.|||months||95% Confidence Interval|Median
2848594|NCT00093496|Secondary|Times to Progression|Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical activity, the interim analysis for Cohort 2 was conducted on the first 11 participants.|||months||95% Confidence Interval|Median
2848595|NCT00093496|Primary|Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.|"Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline."|Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for the primary endpoint.|||proportion of participants|||Number
2848596|NCT00093470|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death from any cause.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients|||months||95% Confidence Interval|Median
2848597|NCT00093470|Primary|Disease-free Survival|Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients|||months||95% Confidence Interval|Median
2848598|NCT00093379|Secondary|Number of Participants With Progression-Free Survival at 2-Year||2 Years|||||||
2848599|NCT00093379|Secondary|2-Year Median Overall Survival||2 Years|||||||
2848600|NCT00093379|Secondary|2-year Local Regional Control||2 Years|||||||
2848601|NCT00093379|Secondary|Number of Participants With 2-year Colostomy-Free Survival|Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.|2 Years with median study follow up of 19 months||||participants|||Number
2848602|NCT00093379|Secondary|Number of Participants With Complete Response at 2 Years|Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 Years|Three (3) participants were not evaluable for response.|||participants|||Number
2848603|NCT00093379|Primary|2 Year Failure Free Survival|Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.|2 years||||participants|||Number
2848604|NCT00093145|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above|Day 1 up to 39 cycles|Treated population|||participants|||Number
2848605|NCT00093145|Secondary|Overall Patient Survival|Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.|From Day 1 until approximately 44 months.|Treated population|||months||95% Confidence Interval|Median
2848606|NCT00093145|Secondary|Duration of Response|Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated Population - Patients with a Confirmed Complete or Partial Overall Response|||months||95% Confidence Interval|Median
2848607|NCT00093145|Secondary|Time to Disease Progression|Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated population|||months||95% Confidence Interval|Median
2848608|NCT00093145|Secondary|Percentage of Participants With a Total Response|Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Evaluated every 2 cycles, up to a maximum of 39 cycles.|Treated population|||percentage of participants||95% Confidence Interval|Number
2848609|NCT00093145|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response|Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.|Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)|The treated population consisted of all randomized participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2848610|NCT00093041|Secondary|Overall Response, Classification|Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.|8 weeks||||participants|||Number
2848611|NCT00093041|Primary|Adverse Events|Number of participants reporting at least one adverse event|Overall Study|Number of participants reporting at least one adverse event|||participants|||Number
2848612|NCT00093015|Secondary|Time to Hospitalization Due to Acute Myocardial Ischemia|Time from randomization to hospitalization due to acute myocardial ischemia. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848613|NCT00093015|Secondary|Change in Patient Reported Fatigue Relative to Baseline at Week 25|Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) - Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue|Baseline and week 25|Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study.|||Units on a scale||Standard Deviation|Mean
2848614|NCT00093015|Secondary|Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline|GFR was estimated using the following MDRD formula: 186 x [Serum creatinine]^(-1.154) x [Age]^(-0.203) x [0.742 if subject is female] x [1.210 if subject is black]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation.|||mL/min/1.73m^2||Standard Deviation|Mean
2848615|NCT00093015|Secondary|Time to End Stage Renal Disease|Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2850081|NCT00078559|Secondary|Number of Deaths Stratified by Sirolimus Withdrawal Status|Participants who died during the study, all cause(s)|Transplantation to Death (up to four years post-transplant)|Intent-to-treat|||deaths|||Number
2848616|NCT00093015|Secondary|Time to Congestive Heart Failure|Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848617|NCT00093015|Secondary|Time to Cerebrovascular Accident|Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848618|NCT00093015|Secondary|Time to Myocardial Infarction|Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848619|NCT00093015|Secondary|Time to Cardiovascular Mortality|Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848620|NCT00093015|Secondary|Time to All-cause Mortality|Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848621|NCT00093015|Primary|Time to All-cause Mortality or End Stage Renal Disease (ESRD)|Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848622|NCT00093015|Primary|Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)|Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.|||Participants|||Number
2848623|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent Change||Standard Deviation|Mean
2848624|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent change||Standard Deviation|Mean
2848625|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent Change||Standard Deviation|Mean
2848626|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.|||Percent Change||Standard Deviation|Mean
2848627|NCT00092677|Secondary|Change From Baseline in Peak Transaortic Jet Velocity|Mean change from baseline in peak transaortic jet velocity|Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication. 180 patients were excluded from peak transaortic jet velocity due to missing measurements.|||m/sec||Standard Deviation|Mean
2848628|NCT00092677|Post-Hoc|Incident Cancer|Number of participants with incident cancer|Entire follow-up (median = 4.35 years)|One patient from the 944 patients randomized to ezetimibe/simvastatin 10/40 mg did not receive study medication and was not included.|||Participants|||Number
2848629|NCT00092677|Post-Hoc|Death Due to Cancer|Number of participants that died due to cancer|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848630|NCT00092677|Other Pre-specified|Death (Any Cause)|Number of participants that died (any cause)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848631|NCT00092677|Other Pre-specified|Nonhemorrhagic Stroke|Number of participants that experienced nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848632|NCT00092677|Other Pre-specified|Hospitalization for Unstable Angina|Number of participants that experienced hospitalization for unstable angina|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848633|NCT00092677|Other Pre-specified|Percutaneous Coronary Intervention (PCI)|Number of participants that experienced percutaneous coronary intervention (PCI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848634|NCT00092677|Other Pre-specified|Coronary Artery Bypass Grafting (CABG)|Number of participants that experienced coronary artery bypass grafting (CABG)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848635|NCT00092677|Other Pre-specified|Nonfatal Myocardial Infarction (MI)|Number of participants that experienced nonfatal myocardial infarction (MI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848636|NCT00092677|Other Pre-specified|Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)|Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848637|NCT00092677|Other Pre-specified|Aortic Valve Replacement (AVR)|Number of participants that experienced aortic valve replacement (AVR)|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848638|NCT00092677|Other Pre-specified|Cardiovascular Death|Number of participants that experienced cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848639|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)|Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848640|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)|Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848641|NCT00092677|Primary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)|Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat|||Participants|||Number
2848642|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males|The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.|||Cases per 100 person-years at risk||95% Confidence Interval|Number
2848643|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females|The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.|||Cases per 100 person-years at risk||95% Confidence Interval|Number
2848667|NCT00092534|Secondary|Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..|At 264 months since Vaccination Dose 1||2026-11-30|11/2026||||
2848644|NCT00092547|Secondary|Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848645|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848646|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)||Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848647|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)||Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848648|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)||Month 18 (Month 12 Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848649|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)||Month 7 (1 Month Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848650|NCT00092547|Secondary|Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848651|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848652|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848653|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848654|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 18 (12 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848655|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 7 (1 Month Postdose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848656|NCT00092547|Primary|Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up|"A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported."|Month 37 to Month 126|The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.|||Participants|||Number
2848657|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848658|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126||Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848659|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848660|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96||Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848661|NCT00092547|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72||Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||milliMerck units/mL||95% Confidence Interval|Geometric Mean
2848662|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.|||Percentage of participants||95% Confidence Interval|Number
2848663|NCT00092547|Primary|Number of Participants Reporting Other (Non-serious) AEs Through Month 18|Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18|Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.|||participants|||Number
2848664|NCT00092547|Primary|Number of Participants Reporting SAEs From Month 18 Through Month 37|Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37|Month 18 to Month 37|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.|||participants|||Number
2848665|NCT00092547|Primary|Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18|"Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to Month 18|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.|||participants|||Number
2848666|NCT00092534|Secondary|Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 264 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.|At 264 months since Vaccination Dose 1||2026-11-30|11/2026||||
2851443|NCT00057837|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death.|Assessed every 3 months for 2 years, then every 6 months for 1 years|Only eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
2848668|NCT00092534|Secondary|Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) ) in the Long-Term Follow-Up (LTFU) Study|Antibodies to HPV types will be measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 are 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. The percentage of participants that are seropositive for each type will be summarized.|At 216 months since Vaccination Dose 1||2026-11-30|11/2026||||
2848669|NCT00092534|Secondary|Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 216 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types will be measured using IgG LIA..|At 216 months since Vaccination Dose 1||2026-11-30|11/2026||||
2848670|NCT00092534|Secondary|Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 168 were 9, 6, 5, and 5 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 168 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||Percentage of Participants||95% Confidence Interval|Number
2848671|NCT00092534|Secondary|Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to HPV types were measured using anti-HPV IgG LIA. The serostatus cut-offs for IgG LIA anti-HPV 6, 11, 16 and 18 at Month 108 were 15, 15, 7, and 10 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 108 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.|||Percentage of Participants||95% Confidence Interval|Number
2848672|NCT00092534|Secondary|Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 168 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848673|NCT00092534|Secondary|Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types were measured using IgG LIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 108 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848674|NCT00092534|Secondary|Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by cLIA; the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 168 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||Percentage of Participants||95% Confidence Interval|Number
2848675|NCT00092534|Secondary|Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types were measured using cLIA. Seropositivity was assessed by competitive Luminex Immunoassay (cLIA); the serostatus cut-offs for anti-HPV 6, 11, 16 and 18 serum cLIA were 20, 16, 20 and 24 milliMerck units (mMU)/mL, respectively. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 108 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.|||Percentage of Participants||95% Confidence Interval|Number
2848676|NCT00092534|Secondary|Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 168 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 168 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses within 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848677|NCT00092534|Secondary|Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, and 18 at Month 108 Assessed by Competitive Luminex Immunoassay (cLIA) in the Long-Term Follow-Up (LTFU) Study|Antibodies to human papillomavirus (HPV) types were measured using cLIA. Because the objective was to demonstrate antibody persistence at 14 years following vaccination in susceptible individuals, Cohort 2 was not included in the analysis.|At 108 months since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were PCR-negative and seronegative based on cLIA to relevant type at Day 1 and PCR-negative to the relevant type through Month 7. No data were collected for Cohort 2.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848678|NCT00092534|Secondary|Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study|This measure is defined to have occurred if on a single biopsy or excised tissue, there is the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 is detected by Thin-section PCR in an adjacent section from the same tissue block.|up to 22 years since Vaccination Dose 1||2026-11-30|11/2026||||
2848679|NCT00092534|Secondary|Incidence of the Composite Endpoint of HPV 6/11/16/18-related CIN (Any Grade), AIS, Cervical Cancer, Vulvar Cancer or Vaginal Cancer the Long-term Follow-up (LTFU) Study|This measure was defined to have occurred if on a single biopsy or excised tissue, there was the NPP consensus diagnosis of CIN 1, CIN 2, CIN 3, AIS, cervical cancer, vulvar cancer or vaginal cancer AND at least 1 of HPV types 6, 11, 16 or 18 was detected by Thin-section PCR in an adjacent section from the same tissue block. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.|Up to 14 years since Vaccination Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect efficacy, had been PCR-negative and seronegative based on cLIA at Day 1 and PCR-negative through Month 7 of the Base Study to relevant HPV type(s), and had LTFU data available.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848680|NCT00092534|Secondary|Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 31/33/35/39/45/51/52/56/58/59-related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Worse in the Long-term Follow-up (LTFU) Study|This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse related to nonvaccine HPV types up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to nonvaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, or 59. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.|Up to 14 years since Vaccination Dose 1|Participants in Cohort 1 who had received ≥1 qHPV vaccination, had any follow up visit in the LTFU, and had been PCR-negative and seronegative based on cLIA to the appropriate HPV type(s) at Day 1.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848681|NCT00092534|Secondary|Number of Participants With Anti-Human Papillomavirus (HPV) 18 Titer ≥24 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study|Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 18 pseudovirions in vitro; thus, the number of participants with anti-HPV 18 ≥24 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.|Week 4 Postdose 3|Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||Number of Participants|||Number
2848682|NCT00092534|Secondary|Number of Participants With Anti-Human Papillomavirus (HPV) 16 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study|Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 16 pseudovirions in vitro; thus, the number of participants with anti-HPV 16 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.|Week 4 Postdose 3|Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||Number of Participants|||Number
2848683|NCT00092534|Secondary|Number of Participants With Anti-Human Papillomavirus (HPV) 11 Titer ≥16 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study|Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 11 virions in vitro; thus, the number of participants with anti-HPV 11 ≥16 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.|Week 4 Postdose 3|Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||Number of Participants|||Number
2848684|NCT00092534|Secondary|Number of Participants With Anti-Human Papillomavirus (HPV) 6 Titer ≥20 mMU/mL Based on Competitive Luminex Immunoassay (cLIA) in the Base Study|Anti-HPV levels >20 mMU/mL neutralize a large input load of HPV 6 pseudovirions in vitro; thus, the number of participants with anti-HPV 6 ≥20 mMU/mL 4 four weeks after the third quadrivalent HPV (qHPV) or placebo vaccination in the Base Study was determined.|Month 7 (4 weeks after Vaccination 3)|Participants who received 3 qHPV vaccine doses and had Month 7 results within acceptable ranges, had no protocol violations that could affect evaluation of vaccine immunogenicity, and were polymerase chain reaction (PCR)-negative and seronegative based on cLIA to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7.|||Number of Participants|||Number
2848931|NCT00090233|Secondary|G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus|Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.|14 days following the 3rd vaccination|Per Protocol Population among participants in Finland using Per-Protocol Case Definition|||Participants|||Number
2848685|NCT00092534|Primary|Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study|This measure is defined to have occurred when, on a single cervical biopsy, ECC, LEEP, or conization specimen, there was HPV Vaccine NPP consensus diagnosis of CIN 2 or worse up to 22 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU will be included.|up to 22 years post Vaccination Dose 1||2026-11-30|11/2026||||
2848686|NCT00092534|Primary|Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study|This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine Nordic pathology panel (NPP) consensus diagnosis of CIN 2 or worse up to 14 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, AIS or cervical cancer related to HPV 16 or 18. Only participants who received qHPV vaccine during the Base Study vaccination period and consented for inclusion in the LTFU are included. Because the objective was to demonstrate qHPV vaccine prophylactic efficacy at 14 years, Cohort 2 was not included in the analysis.|Up to 14 years since Vaccine Dose 1|Participants in Cohort 1 who received 3 qHPV vaccine doses in 1 year, had no protocol violations that could affect evaluation of efficacy, had been PCR-negative and seronegative based on cLIA at Day 1 and PCR-negative through Month 7 of the Base Study to the relevant HPV type(s), and had LTFU data available.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848687|NCT00092534|Primary|Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study|This measure is defined to have occurred when, on a single cervical biopsy, endocervical curettage (ECC), loop electrosurgical excision procedure (LEEP), or conization specimen, there was HPV Vaccine consensus diagnosis of CIN 2 or worse up to 4 years after the first vaccination. For this measure, CIN 2 or worse includes CIN 2, CIN 3, adenocarcinoma in situ (AIS) or cervical cancer related to HPV 16 or 18.|Up to 4 years|Participants who received 3 qHPV doses in 1 year, had no protocol violations that could affect evaluation of vaccine efficacy, were polymerase chain reaction (PCR)-negative and seronegative based on competitive Luminex immunoassay (cLIA) to the relevant type at Day 1 and PCR-negative to the relevant type through Month 7, and had data available.|||Incidence per 100 person-years|||Number
2848688|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]||Follow-up through end of study (4 years)|"Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."|||incidence rate per 100 person-years|||Number
2848689|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer||Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.|||incidence rate per 100 person-years|||Number
2848690|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848691|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
2848692|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848693|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||Subjects|||Number
2848694|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848695|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
2848696|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
2850224|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
2848697|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL|||Number
2848698|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848699|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
2848700|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848701|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||Subjects|||Number
2848702|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848703|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.|||Subjects|||Number
2848704|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848705|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.|||Subjects|||Number
2848706|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848707|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)|SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848708|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848709|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Clinical Adverse Experiences|A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848710|NCT00092456|Other Pre-specified|Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848711|NCT00092456|Other Pre-specified|Number of Subjects With Vaccine-Related Clinical AEs (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848712|NCT00092456|Other Pre-specified|Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)|Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up|||Participants|||Number
2848713|NCT00092456|Other Pre-specified|Number of Subjects With Clinical Adverse Experiences (CAEs)|Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|Safety Population: All subjects who were vaccinated and followed up|||Participants|||Number
2848714|NCT00092456|Other Pre-specified|Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).|Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.|||units/mL||95% Confidence Interval|Geometric Mean
2848715|NCT00092456|Primary|Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]|Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.|||dilution units||95% Confidence Interval|Geometric Mean
2848716|NCT00092443|Secondary|Number of Subjects With ≥3 Fold Rise in Antibody Titer|Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.|||Participants|||Number
2848717|NCT00092443|Primary|Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.|G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.|||Participants|||Number
2848718|NCT00092417|Other Pre-specified|Number of Participants With Fevers ≥101.0°F [≥38.3°C]|Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination.|Day 1-21 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up.|||Participants|||Number
2848719|NCT00092417|Other Pre-specified|Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
2848720|NCT00092417|Other Pre-specified|Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
2848721|NCT00092417|Primary|Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)||Day 1-5 postvaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
2848722|NCT00092417|Primary|Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)|The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.|Day 1-42 post vaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.|||Participants|||Number
2848723|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2848724|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2848725|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2848726|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
2848727|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
2848728|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
2848729|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
2848730|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
2848731|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2848732|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2848733|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2848734|NCT00092131|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
2848753|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Osteocalcin|Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848735|NCT00092118|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period|Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.|Baseline and Week 6|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available|||Score on a scale||95% Confidence Interval|Least Squares Mean
2848736|NCT00092118|Secondary|Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.|At the end of the 6 week treatment period|The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2848737|NCT00092118|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis|Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].|6 week treatment period (from baseline though the end of week 6)|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2848738|NCT00091962|Secondary|Disease-Specific Health-Related Quality of Life|The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).|8 months post CABG||||units on a scale||Standard Error|Mean
2848739|NCT00091962|Secondary|Generic Physical Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.~Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|8 months post CABG||||participants||Standard Error|Mean
2848740|NCT00091962|Secondary|Hamilton Rating Scale for Depression|The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient's mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905|8 months post CABG||||units on a scale||Standard Error|Mean
2848741|NCT00091962|Primary|Generic Mental Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.~Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|Measured 8 months post-CABG||||units on a scale||Standard Error|Mean
2848742|NCT00091949|Secondary|Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure||5 years||||participants|||Number
2848743|NCT00091949|Secondary|Decline in Cognitive Status|Change in modified mental status examination (3MS) score from baseline to exit. Theoretical range of 3MS scores is 0-100. Baseline scores ranged from 22-100.|Annual measures from baseline to exit (up to 5 years)|Participants with baseline and at least 1 follow-up modified mini-mental examination score.|||units on a scale||Standard Error|Mean
2848744|NCT00091949|Secondary|All Cause Mortality||5 years||||participants|||Number
2848745|NCT00091949|Secondary|Development of Overt Diabetes||5 years||||participants|||Number
2848746|NCT00091949|Secondary|Acute Coronary Syndrome|Fatal or non-fatal acute myocardial infarction or unstable angina|5 years||||participants|||Number
2848747|NCT00091949|Secondary|Fatal or Non-fatal Stroke Alone||5 years||||participants|||Number
2848748|NCT00091949|Primary|Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction||Up to 5 years||||participants|||Number
2848749|NCT00091832|Secondary|Number of Participants With Hypercalcemia|Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.|Day 1 to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Participants|||Number
2848750|NCT00091832|Secondary|Number of Participants With Skeletal Related Events|Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|From Day 1 to Week 25|All participants who were exposed to investigational product.|||Participants|||Number
2848751|NCT00091832|Secondary|Time to First Skeletal Related Event|Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1 to Week 25|All participants who were exposed to investigational product.|||Days||95% Confidence Interval|Median
2848752|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Osteocalcin|Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848785|NCT00091507|Primary|Progression of Acute Coronary Syndrome to Myocardial Infarction|Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.|24 hours||||participants|||Number
2848754|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848755|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848756|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848757|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848758|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in P1NP|Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848759|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)|Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848760|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)|Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848761|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)|Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848762|NCT00091832|Secondary|Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline|Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.|Baseline to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Days||Inter-Quartile Range|Median
2848763|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25|The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Participants|||Number
2848764|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13|The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a Baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Participants|||Number
2848828|NCT00090857|Primary|Change in Hip Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of hip density.|||g/cm^2||Full Range|Median
2848765|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)|Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848766|NCT00091832|Primary|Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)|Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).|||Percent change||Standard Deviation|Mean
2848767|NCT00091819|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7-14 days following end of antibiotic treatment|Data for the all-treated (AT) population are presented. the AT and clinically evaluable (CE) populations were considered co-primary.|||participants|||Number
2848768|NCT00091793|Secondary|Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848769|NCT00091793|Secondary|Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848770|NCT00091793|Secondary|Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848771|NCT00091793|Secondary|Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848772|NCT00091793|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848773|NCT00091793|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848774|NCT00091793|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848775|NCT00091793|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848776|NCT00091793|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848777|NCT00091572|Secondary|Duration of Objective Response|Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.|Treatment continued until disease progression or unacceptable toxicity.|All responders|||Months||95% Confidence Interval|Median
2848778|NCT00091572|Secondary|Objective Response Rate in Subjects With Measurable Lesions|Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.|Treatment continued until disease progression or unacceptable toxicity.|Intent to treat population with measurable disease at Baseline.|||Ratio||95% Confidence Interval|Median
2848779|NCT00091572|Primary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|The final analysis was to be performed when at least 616 deaths had occurred.|Intent to Treat Population|||Months||95% Confidence Interval|Median
2848780|NCT00091572|Secondary|Progression Free Survival|Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.|Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.|Intent to Treat Population|||Months||95% Confidence Interval|Median
2848781|NCT00091507|Secondary|Cardiac Arrest or Acute Mortality|Outcome for all participants (composite of cardiac arrest or acute mortality)|Prehospital setting through hospitalization||||participants|||Number
2848782|NCT00091507|Secondary|Mortality|Outcome for all participants (mortality at 30 days).|30 days|30 day mortality.|||participants|||Number
2848783|NCT00091507|Secondary|Heart Failure or Death|Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)|30 days||||participants|||Number
2848784|NCT00091507|Secondary|Cardiac Arrest|Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.|1 to 18 hours (From prehospital setting through hospitalization.)||||participants|||Number
2848786|NCT00091442|Primary|Time to Progression|Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.|From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled|Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.|||Months||95% Confidence Interval|Median
2848787|NCT00091442|Secondary|Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)|Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).|Up to 30 to 42 days after last dose of study medication|Evaluable population: Included all randomized participants who received at least 1 dose of study medication (DOXIL or docetaxel), and who had at least 1 postbaseline tumor assessment.|||Participants|||Number
2848788|NCT00091442|Secondary|Overall Survival|Time interval in months between the date of randomization and the participant's death from any cause.|From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled|Intent to Treat: If the date of death was unknown, the data were censored at the date that the participant was last known to have been alive.|||Months||95% Confidence Interval|Median
2848789|NCT00091390|Secondary|Clinical Progression Including Local/Regional and Distant Relapse||From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.|||||||
2848790|NCT00091390|Secondary|Disease-specific Survival||From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up.|||||||
2848791|NCT00091390|Secondary|Overall Survival||From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.|||||||
2848792|NCT00091390|Secondary|Biochemical Failure||From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.|||||||
2848793|NCT00091390|Secondary|Acute Severe GU and GI Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Within 9 Months of Starting Treatment||From registration until 9 months from the start of treatment|||||||
2848794|NCT00091390|Primary|Late Severe Genitourinary (GU) and Gastrointestinal (GI) Toxicity at 18 Months|Eighteen-month rate of late severe (grade 3-5) genitourinary (GU) and gastrointestinal (GI) toxicity, defined as starting more than 9 months from treatment start, and graded by CTCAE v3.0|Beginning nine months after start of treatment.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2848795|NCT00091273|Secondary|Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay||Days 1,8,15,22,29,36,43,50 and Month 3|All treated subjects were assessed.|||participants|||Number
2848796|NCT00091273|Primary|Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay||Day 22|All treated subjects were assessed.|||participants|||Number
2848797|NCT00091273|Primary|Safety of the Vaccine|Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.|Days 1,8,15,22,29,36,43,50|All treated subjects were assessed.|||participants|||Number
2848798|NCT00091260|Secondary|Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response||1 year||||participants|||Number
2848799|NCT00091260|Primary|Number of Patients With Hematologic Response With Single-agent CC-5013|"Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.~Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.~For patients with an elevated serum free light chain assay, a reduction of 50% or more."|3 months|Participants who received at least 3 cycles of single-agent CC-5013 and underwent subsequent evaluation.|||Participants|||Count of Participants
2848800|NCT00091260|Primary|Number of Patients Removed From Study Treatment Due to Toxicities||1 year|Number of patients who had at least one dose of CC-5013|||participants|||Number
2848801|NCT00091169|Secondary|Proportion of Patients With Stable or Improving Performance Status at 4 Weeks|Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.|assessed at baseline and 4 weeks after randomization|All randomized patients who had performance status data at baseline and 4 weeks|||proportion of participants||95% Confidence Interval|Number
2848802|NCT00091169|Secondary|Prevalence of Carnitine Deficiency at 4 Weeks|Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine > 0.4 μmol/L or free carnitine < 35 μmol/L for males and < 25 μmol/L for females.|assessed at 4 weeks after randomization|All randomized patients who had carnitine data at 4 weeks|||proportion of participants||95% Confidence Interval|Number
2848803|NCT00091169|Secondary|Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks|Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported BPI score at both baseline and 4 weeks|||units on a scale||95% Confidence Interval|Mean
2850225|NCT00076999|Secondary|Baseline Median Viral Load log10 Copies/mL||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
2848804|NCT00091169|Secondary|Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline|Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported CES-D score at both baseline and 4 weeks|||units on a scale||95% Confidence Interval|Mean
2848805|NCT00091169|Secondary|Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks|Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported FACIT-F score at both baseline and 4 weeks|||units on a scale||95% Confidence Interval|Mean
2848806|NCT00091169|Primary|Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks|Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients|||units on a scale||95% Confidence Interval|Mean
2848807|NCT00091026|Secondary|Overall Survival|Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months||||Months||95% Confidence Interval|Median
2848808|NCT00091026|Secondary|Progression-free Survival|Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months||||months||95% Confidence Interval|Median
2848809|NCT00091026|Primary|Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 6 months||||percentage of participants||95% Confidence Interval|Number
2848810|NCT00090987|Secondary|Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus||12 months|||||||
2848811|NCT00090987|Secondary|Mechanisms of Primary and Secondary Resistance to Imatinib Therapy|Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression|12 months|||||||
2848812|NCT00090987|Secondary|Pharmacokinetic Profile of Imatinib and Antiretrovirals||12 months|||||||
2848813|NCT00090987|Secondary|Cytokine Profiles Before and After Imatinib Therapy||12 months|||||||
2848814|NCT00090987|Secondary|Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry||12 months|||||||
2848815|NCT00090987|Primary|Proportion of Patients Who Achieve a Clinical Response|Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for >4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions|20-24 weeks||||proportion|||Number
2848816|NCT00090870|Secondary|Progression-free Survival||From registration until diease progression or death, whichever comes first.|Data for this endpoint was not collected||||||
2848817|NCT00090870|Secondary|Frequency of Adverse Events Assessed by NCI CTC Version 2||From the first day of treatment until the end of treatment visit, an average of 6 months|Data for this endpoint was not collected||||||
2848818|NCT00090870|Secondary|Duration of Response||time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.|Data for this endpoint was not collected||||||
2848819|NCT00090870|Primary|Response Rate|To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide|while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year|Data for this endpoint was not collected||||||
2848820|NCT00090857|Secondary|Worst Grade Fatigue|Participants reported worst grade fatigue: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
2848821|NCT00090857|Secondary|Worst Grade Headache|Participants reported worst grade headache: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
2848822|NCT00090857|Secondary|Worst Grade Bone Pain|Participants reported worst grade bone pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.||||Participants|||Count of Participants
2848823|NCT00090857|Secondary|Worst Grade Abdominal Pain|Participants reported worst grade abdominal pain: 01: mild, 02: moderate, 03: severe (CTCAEv3), 04: disabling (CTCAEv3) during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
2848824|NCT00090857|Secondary|Worst Grade Vomiting|Participants reported worst grade vomiting grade 01: 1x in 24 hours, 02: 2-5x in 24 hours, 03: >/= 6x in 24 hours, grade 04: requiring parenteral nutrition/intensive care during 12 months of treatment.|Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.|The analysis dataset is comprised of all randomized participants.|||Participants|||Count of Participants
2849207|NCT00089141|Secondary|Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy|Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease|2 years||||participants|||Number
2848829|NCT00090857|Primary|Change in Trochanter Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of trochanter density.|||g/cm^2||Full Range|Median
2848830|NCT00090857|Primary|Change in Femoral Neck Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of femoral neck density.|||g/cm^2||Full Range|Median
2848831|NCT00090857|Primary|Change in Lumbar Density From Baseline to 12 Months|The bone mineral density (BMD) test was comprised of the following 4 measurements [total density (g/cm^2)]: lumbar, femoral neck, trochanter, hip.|Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.|The analysis dataset is comprised of randomized patients with an evaluable sample for analysis of lumbar density.|||g/cm^2||Full Range|Median
2848832|NCT00090844|Secondary|Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.|5 years after end of chemotherapy|||||||
2848833|NCT00090844|Secondary|Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years.|Baseline, through chemotherapy then 5 years|||||||
2848834|NCT00090844|Secondary|Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.|Baseline, end of chemotherapy then 5 years|||||||
2848835|NCT00090844|Secondary|Chemotherapy-related Amenorrhea|Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.|Baseline, end of chemotherapy then 5 years|||||||
2848836|NCT00090844|Primary|Time to Resumption of Menses|Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years|Baseline, end of chemotherapy then 5 years||||months||Full Range|Median
2848837|NCT00090779|Secondary|Time to Treatment Initiation or Death|5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death|5 years since randomization|All eligible subjects were included except one subject in IT arm with baseline multidrug resistance.|||weeks||95% Confidence Interval|Number
2848838|NCT00090779|Secondary|Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Through database cutoff for DSMB review (by July 2, 2009). The analysis includes only those in the IT arm who continued ART through week 36 (n=49), compared to all in the DT arm (n=64).|||weeks||95% Confidence Interval|Number
2848839|NCT00090779|Secondary|Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Throughout database cutoff for DSMB review (by July 2, 2009).|||weeks||95% Confidence Interval|Number
2848840|NCT00090779|Secondary|Number of Participants in IT Arm Off Treatment Before 36 Weeks|The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm.|At Week 36|All 66 eligible subjects in IT arm were included.|||participants|||Number
2848841|NCT00090779|Secondary|Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis.|96 weeks since randomization|All 130 eligible subjects were included.|||Participants|||Number
2848842|NCT00090779|Secondary|Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm||IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)|One subject in IT arm with multidrug resistance at baseline was excluded from this analysis.|||Change in Log10 transformed CD4 Counts||Standard Deviation|Mean
2848843|NCT00090779|Primary|Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.||96 weeks since randomization||||participants|||Number
2848844|NCT00090779|Primary|Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm|"The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D."|IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)|Participants in follow-up at least 72 weeks since randomization were included.|||rank||Full Range|Median
2848845|NCT00090779|Primary|Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm|"The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D."|At Weeks 72 and 76|Participants in follow-up at least 72 weeks since randomization were included.|||rank||Full Range|Median
2848846|NCT00090766|Secondary|Number of Participants Who Experienced Episodes of Rejection Over Time|Participants with biopsy proven active rejection are reported.|Up to Week 26|The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.|||participants|||Number
2848847|NCT00090766|Secondary|Mean Elimination Half-Life of Valganciclovir Over Time|The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.|||hours||Standard Deviation|Mean
2848848|NCT00090766|Secondary|Mean Maximum Plasma Concentration of Valganciclovir Over Time|Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|||mcg/mL||Standard Deviation|Mean
2848849|NCT00090766|Secondary|Number of Participants Who Experienced Graft Loss|Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.|Up to Week 26|ITT population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.|||participants|||Number
2848850|NCT00090766|Secondary|Number of Participants With Treatment Failures|Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.|Up to Week 26|The Intent to Treat (ITT) population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.|||participants|||Number
2848851|NCT00090766|Secondary|Number of Participants With Cytomegalovirus Disease Over Time|Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848852|NCT00090766|Primary|Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848853|NCT00090766|Primary|Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848932|NCT00090233|Primary|Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo|Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.|Within 42 days following any dose of RotaTeq™/placebo|All participants in the study were followed for potential cases of intussusception.|||Participants|||Number
2848854|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848855|NCT00090766|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848856|NCT00090766|Primary|Number of Participants With Opportunistic Infections|Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848857|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Dose Interruption or Modification|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.|||participants|||Number
2848858|NCT00090766|Primary|Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|Pharmacokinetic (PK) population comprised of all participants from studies WP16296, WP16303 and WV16726 who had completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|||mcg*hr/mL||Standard Deviation|Mean
2848859|NCT00090753|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event|See the adverse events section of the results for more information.|From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)|Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.|||Percentage of participants|||Number
2848860|NCT00090753|Primary|Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation|Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.|Baseline to the end of the study (Up to 49 Months)|Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.|||g/dL||Standard Deviation|Mean
2848861|NCT00090610|Secondary|Median Overall Survival||Every 6 months starting at 12 months, to 24 months||||months||95% Confidence Interval|Median
2848862|NCT00090610|Secondary|Recurrence-Free Survival|Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.|Every 6 months starting at 12 months, to 24 months|Subjects who had a complete response.|||months||95% Confidence Interval|Median
2848863|NCT00090610|Secondary|Quality of Life|"Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)~With these instruments, a higher score indicates better health-related quality of life."|Baseline performed 14 days before first dose, then every other cycle and at study termination|The number of participants was based on QoL data available for Arm 1 and one patient withdrew on Arm 2.|||units on a scale||Standard Deviation|Mean
2848864|NCT00090610|Secondary|Objective Response Rate|"Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.~OR = CR + PR"|Every 6 months, starting at 12 months to 24 months|Same as for PFS|||percentage of participants||95% Confidence Interval|Number
2848890|NCT00090363|Primary|Time to Progression (TTP)|Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).||||Days||Inter-Quartile Range|Median
2848865|NCT00090610|Primary|Progression-free Survival (PFS)|"Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression~Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease."|Every 6 months, to 18 months|1 patient in each arm was excluded. The patient in Arm 1 did not complete 1 cycle of therapy. A patient in Arm 2 withdrew from the study|||months||95% Confidence Interval|Median
2848866|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|8 months|Participants who completed the perceived improvement item at 8 months.|||participants|||Number
2848867|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|10 weeks|Participants who completed the satisfaction item at 10 weeks.|||participants|||Number
2848868|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question How satisfied are you with your progress?"|8 months|Number of participants who completed the 8 months satisfaction questions|||participants|||Number
2848869|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question, How satisfied are you with your progress?"|10 weeks|Number of women who completed satisfaction question at 10 weeks.|||participants|||Number
2848870|NCT00090584|Secondary|Symptom Bother|Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.|baseline, 10 weeks and 8 months|Participants who completed OAB-q assessment at each time in each treatment group.|||units on a scale||Standard Deviation|Mean
2848871|NCT00090584|Secondary|Symptom Distress|Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.|baseline, 10 weeks and 8 months|All women who completed UDI at each time in each treatment group|||units on a scale||Standard Deviation|Mean
2848872|NCT00090584|Secondary|Change in Voids Per Day|Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary|baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.|||voids per day||Standard Error|Mean
2848873|NCT00090584|Secondary|Change in Incontinence Episodes|Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.|Baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.|||incontinence episodes per week||Standard Error|Mean
2848874|NCT00090584|Primary|Proportion of Women Who Meet Definition of Success|Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.|8 months|All women who completed the 8 months assessment or were known to return to drug use prior to that time.|||participants|||Number
2848875|NCT00090519|Primary|Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye|The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants with at least 1 eligible study eye analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||participants|||Number
2848876|NCT00090519|Secondary|Number of Participants With Adverse Events|Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.|Baseline through 36 Months|Safety population: all randomized participants who received at least one dose of study drug.|||participants|||Number
2848877|NCT00090519|Secondary|Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months|25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.|36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||units on a scale||Standard Deviation|Mean
2848878|NCT00090519|Secondary|Change From Baseline at Endpoint in Albumin/Creatinine Ratio||36 Months|The completer population includes participants who completed all 36 months of the treatment phase.|||micrograms/millimole (ug/mmol)||Standard Deviation|Mean
2848879|NCT00090519|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate|The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||milliliter/minute/1.73 square meter||Standard Deviation|Mean
2848880|NCT00090519|Secondary|Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography|Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||participants|||Number
2848881|NCT00090519|Secondary|Change From Baseline in Contrast Sensitivity by Pelli-Robson|Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants analyzed according to treatment group to which they were originally assigned by random allocation even if they did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.|||Letters read correctly|Participants|Standard Deviation|Mean
2848882|NCT00090519|Secondary|First Occurrence of Focal/Grid Photocoagulation|The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||participants|||Number
2848883|NCT00090519|Secondary|Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months|ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||Letters read correctly|Participants|Standard Deviation|Mean
2848884|NCT00090519|Primary|Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)|Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.|6 Months through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.|||months per participant||Standard Deviation|Mean
2848885|NCT00090493|Primary|The Number of Participants Experiencing a Response to the Peptide Vaccines.|The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.|2 week intervals|only 2 were complete per protocol. 2 were withdrawn by physician due to relapse.|||participants|||Number
2848886|NCT00090363|Secondary|Change in Number of Bone Metastases Over Time|Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.|Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.||||Percentage Change||Standard Deviation|Mean
2848887|NCT00090363|Secondary|Objective Response Rate (ORR)|Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.|For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|Only patients with measurable disease at the baseline were included in the analysis.|||percentage of participants|||Number
2848888|NCT00090363|Secondary|Change in Total Prostate Specific Antigen (PSA) Over Time|Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.|Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|The analysis population only includes patients with baseline and Week 12 PSA measurements|||Percentage Change in PSA||Standard Deviation|Mean
2848889|NCT00090363|Secondary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).||||Days||Inter-Quartile Range|Median
2848894|NCT00090545|Secondary|Overall Response Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)|Overall response was evaluated by the RECIST. Complete Response (CR) is the disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Every 2 cycles (1 cycle = 28 days)|For stage 1, not all patients were analyzed for RECIST. Some patients came off study for rising prostatic specific antigen (PSA) only.|||Participants|||Count of Participants
2848895|NCT00090545|Secondary|Median Overall Survival|Time from treatment start date until date of death or date last known alive.|Time from treatment start date until date of death or date last known alive, approximately 18.3 months.||||Months||95% Confidence Interval|Median
2848896|NCT00090545|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 49 months.||||Participants|||Count of Participants
2848897|NCT00090545|Primary|Progression Free Survival|Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.|4 months||||months||95% Confidence Interval|Median
2848898|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA|Antibodies to HPV types were measured using IgG LIA. Thresholds for seropositive were ≥9, 6, 5, and 5 IgG LIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study..|||Percentage of participants||95% Confidence Interval|Number
2848899|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)|Antibodies to HPV types were measured using Luminex immunoassay (IgG-LIA). The unit of measure for this assay is IgG LIA mMU/mL; this unit cannot be directly compared with the cLIA mMU/mL unit reported for the cLIA results.|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||IgG LIA mMU/mL||95% Confidence Interval|Geometric Mean
2848900|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
2848901|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 72|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
2848902|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 36|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
2848903|NCT00090285|Secondary|Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.|Month 7|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||Percentage of participants||95% Confidence Interval|Number
2848904|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 120|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
2848905|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 72|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
2848906|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 36|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
2848907|NCT00090285|Secondary|Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)|Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).|Month 7|All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.|||cLIA mMU/mL||95% Confidence Interval|Geometric Mean
2848908|NCT00090285|Secondary|Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection|Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed.|Base study: through Month 36|Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Detection per 100 person-years|||Number
2848909|NCT00090285|Secondary|Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection|Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed.|Base study: through Month 36|Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Infection per 100 person-years|||Number
2848910|NCT00090285|Other Pre-specified|Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)|Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up was assessed.|Base study: through Month 36|Only a subset of participants was included for this sub-study. Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Incidence per 100 person-years|||Number
2848911|NCT00090285|Primary|LTFU (EXT2): Number of Participants Who Died|The number of participants who died was assessed.|LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine|The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).|||Participants|||Count of Participants
2848912|NCT00090285|Primary|LTFU (EXT2): Number of Participants With Vaccine-Related SAEs|An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.|LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine|The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).|||Participants|||Count of Participants
2848913|NCT00090285|Primary|Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)|A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.|Base study: through Month 36|The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.|||Participants|||Count of Participants
2848914|NCT00090285|Primary|Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.|Base study: through Day 5 after any vaccination|The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.|||Participants|||Count of Participants
2848915|NCT00090285|Primary|Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer|Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.|Up to 10 years after the first dose of qHPV vaccine|Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to MSM in the Base Study qHPV vaccine group.|||Incidence per 10,000 person-years||95% Confidence Interval|Number
2848930|NCT00090233|Primary|Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination|Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.|At least 14 days following the 3rd vaccination through the first full rotavirus season|Per Protocol Population Using Per-Protocol Case Definition|||Participants|||Number
2848916|NCT00090285|Primary|Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer|Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.|Up to 10 years after the first dose of qHPV vaccine|Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.|||Incidence per 10,000 person-years||95% Confidence Interval|Number
2848917|NCT00090285|Primary|Overall Study: Incidence of HPV Type 6/11-related Genital Warts|Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.|Up to 10 years after the first dose of qHPV vaccine|Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.|||Incidence per 10,000 person-years||95% Confidence Interval|Number
2848918|NCT00090285|Primary|Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer|Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.|Base study: through Month 36|Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.|||Incidence per 100 person-years|||Number
2848919|NCT00090259|Secondary|Number of Participants That Experienced Cardiovascular Hospitalization||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
2848920|NCT00090259|Secondary|Number of Participants That Were Hospitalized for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
2848921|NCT00090259|Secondary|Number of Participants That Died (Any Cause)||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
2848922|NCT00090259|Secondary|Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization|Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.|Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
2848923|NCT00090259|Primary|Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat|||Participants|||Number
2848924|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.|||micrograms/mL||95% Confidence Interval|Geometric Mean
2848925|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.|||ELISA units/mL||95% Confidence Interval|Geometric Mean
2848926|NCT00090233|Secondary|Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo|The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria.|42 days following third dose|Per Protocol Population|||Participants|||Number
2848927|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose|Number of participants with rotavirus gastroenteritis whose clinical score was >16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition|||Participants|||Number
2848928|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.|Number of participants with rotavirus gastroenteritis whose clinical score was >8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition|||Participants|||Number
2848929|NCT00090233|Secondary|Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4|Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.|At least 14 days following the 3rd vaccination|Per Protocol Population Using Per-Protocol Case Definition|||Annual # of events per 1000 person-years|||Number
2848933|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848934|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848935|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848936|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848937|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848938|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848939|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7|||Incidence per 100 person-years|||Number
2848940|NCT00090220|Secondary|Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|||||||
2848941|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848942|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
2849092|NCT00089661|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Subjects with non-missing baseline and >= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2848943|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848944|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848945|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848946|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848947|NCT00090220|Secondary|Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7|||Incidence per 100 person-years|||Number
2848948|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848949|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848950|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848951|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2849208|NCT00089141|Secondary|Definitive Absence of Efficacy Success|Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy|2 years||||participants|||Number
2848952|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848953|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848954|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848955|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||Percentage of participants||95% Confidence Interval|Number
2848956|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848957|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848958|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848959|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2849093|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were to have been analyzed by ELISA analysis; however, no data were collected.|1 year||||pg/mL||Full Range|Mean
2848960|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848961|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848962|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848963|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.|||mMU/mL||95% Confidence Interval|Geometric Mean
2848964|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848965|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848966|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Incidence per 100 person-years||95% Confidence Interval|Number
2848967|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848968|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2849209|NCT00089141|Primary|Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy|Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy|2 years||||participants|||Number
2848969|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.|||Cumulative Incidence Probability||95% Confidence Interval|Number
2848970|NCT00090220|Primary|Number of Participants With an SAE Resulting in Death After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up|||Participants|||Number
2848971|NCT00090220|Primary|Number of Participants With Vaccine-Related SAEs After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up|||Participants|||Number
2848972|NCT00090220|Primary|Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received >=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up|||Participants|||Number
2848973|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.|Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7|||Incidence per 100 person-years|||Number
2848974|NCT00090402|Secondary|Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months|The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks.|baseline, 12 months|In the placebo group there were 2 discontinuations (1 moved, 1 death). In the fish oil group there were 2 discontinuations (1 discontinue, 1 death). In the fish oil and lipoic acid group there was 1 discontinuation (due to meds). These discontinuations did not complete the study.|||units on a scale||Standard Error|Mean
2848975|NCT00090402|Primary|Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months|The MMSE is a measure of global cognitive function, and scores range from 0-30, with a lower score indicates greater cognitive impairment.|baseline, 12 months||||units on a scale||Standard Deviation|Mean
2848976|NCT00090402|Primary|F2-isoprostane Level Urine F2-Isoprostanes|F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.|baseline, 12 months|intention to treat (ITT)|||nanogram per miligram||Standard Deviation|Mean
2848977|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2848978|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2849210|NCT00089128|Secondary|Progression-free Survival||Time between registration and disease progression or death, whichever comes first.|data for this endpoint was not collected||||||
2848979|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Minutes||Standard Deviation|Mean
2848980|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis was an MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
2848981|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
2848982|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.|||(percent change) *minutes||Standard Deviation|Mean
2848983|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
2848984|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
2848985|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Participants|||Number
2848986|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|"The secondary efficacy analysis used a modified~intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."|||Participants|||Number
2848987|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|"The secondary efficacy analysis used a modified~intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."|||Participants|||Number
2848988|NCT00090142|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.|||Percent Change||Standard Deviation|Mean
2848989|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2849094|NCT00089648|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT|||pg/mL||Full Range|Mean
2848990|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848991|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848992|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848993|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848994|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848995|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848996|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848997|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848998|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2848999|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2849000|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.|||participants|||Number
2849001|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48|The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.|Baseline and Months 12, 24, 36, 48|ITT Population. As the study progressed, participants dropped out of the study.|||points on a scale||Standard Error|Least Squares Mean
2849002|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48|The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.|||points on a scale||Standard Error|Least Squares Mean
2849003|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was yes, the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out the study.|||visits|||Number
2849004|NCT00090103|Secondary|Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was yes, the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of the study.|||visits|||Number
2849005|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of study.|||yes responses|||Number
2849006|NCT00090103|Secondary|Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.|||visits|||Number
2849007|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?."|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was yes, the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.|||yes responses|||Number
2849211|NCT00089128|Secondary|Frequency of Adverse Events as Assessed by NCI CTC Version 2.0||From the day of first dose until the end of study, an average of 6 months|data for this endpoint was not collected||||||
2849008|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was yes, the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.|||visits|||Number
2849009|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48|Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Transition zone measurements were only done on a subset of participants at sites with experience in measuring the transition zone of the prostate. Also, transition zone measurements were either not performed or missing for some participants at various timepoints.|||percent change||Standard Error|Least Squares Mean
2849010|NCT00090103|Secondary|Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48|Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints.|||percent change||Standard Error|Least Squares Mean
2849011|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48|Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes <125 ml were not included in the analysis.|||milliliters (mL)/second (sec)||Standard Error|Least Squares Mean
2849012|NCT00090103|Secondary|Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.|||points on a scale||Standard Error|Least Squares Mean
2849013|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Hematospermia|A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population|||participants|||Number
2849014|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria|A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population|||participants|||Number
2849015|NCT00090103|Secondary|Number of Events of Symptom Deterioration at the Indicated Time Periods|The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).|Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.|||events|||Number
2849016|NCT00090103|Secondary|The Number of Participants With Each of the Five Components of BPH Clinical Progression|The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.|Baseline (Day 1) to Year 4|ITT Population|||participants|||Number
2849017|NCT00090103|Primary|Number of Participants With AUR or BPH-related Surgery|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.|Baseline (Day 1) through Year 4|ITT Population|||participants|||Number
2849018|NCT00090103|Secondary|Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4|The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.|Years 1, 2, 3, and 4|ITT Population. As the study progressed, participants dropped out of the study.|||events|||Number
2849019|NCT00090103|Primary|Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.|Years 1, 2, 3, and 4|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.|||events|||Number
2849020|NCT00090051|Secondary|Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment|Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population,all randomized participants, who started a new treatment for CLL or died.|||Days||95% Confidence Interval|Median
2849021|NCT00090051|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete or partial response.|||Days||95% Confidence Interval|Median
2849022|NCT00090051|Secondary|Final Analysis: Time to Disease-Free Survival Event|Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete response. .|||Days||95% Confidence Interval|Median
2849023|NCT00090051|Secondary|Final Analysis: Percentage of Participants With Complete Response|Complete response was defined as the disappearance of all signs of cancer in response to treatment.|Median observation time was approximately 5 years|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2849024|NCT00090051|Secondary|Final Analysis: Time to Event-Free Survival Event|Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.|||Days||95% Confidence Interval|Median
2849025|NCT00090051|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.|Median observation time was approximately 5 years|The analysis included only those participants from the Intent-to-treat population,all randomized participants, who died. Participants who had not died at the time of the final analysis were censored at the date of the last contact.|||Days||95% Confidence Interval|Median
2849026|NCT00090051|Primary|Final Analysis: Time to Progression-Free Survival Event|Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact.|||Days||95% Confidence Interval|Median
2849027|NCT00090051|Secondary|Number of Participants With Disease-free Survival (DFS) Events|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population with a Best Overall Response of Complete Response.|||participants|||Number
2849028|NCT00090051|Secondary|Disease-free Survival (DFS)|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.|||Days||95% Confidence Interval|Median
2849029|NCT00090051|Primary|Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||participants|||Number
2849030|NCT00090051|Secondary|Number of Participants With Event-free Survival (EFS) Events|Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||participants|||Number
2849212|NCT00089128|Secondary|Duration of Response||From registration until disease progression among patients who had at least a partial response.|Data for this endpoint was not collected||||||
2849031|NCT00090051|Secondary|Event-free Survival (EFS)|Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||Days||95% Confidence Interval|Median
2849032|NCT00090051|Secondary|Number of Participants With Overall Survival (OS) Events|Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||participants|||Number
2849033|NCT00090051|Secondary|Overall Survival (OS)|Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||Days||95% Confidence Interval|Median
2849034|NCT00090051|Primary|Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.|||Days||95% Confidence Interval|Median
2849035|NCT00003224|Other Pre-specified|Number of Participants With a Proliferative Response to Tetanus Helper Peptide|Proliferative response measured in participants using a tritiated thymidine incorporation assay with peripheral blood mononuclear cells (PBMC) stimulated with the tetanus peptide in vitro, and measured at 5 days after in vitro culture.|during vaccination|All evaluable enrolled patients were assayed.|||participants|||Number
2849036|NCT00003224|Secondary|Immunogenicity of Each Vaccine Regimen|T cell responses to the p946 (gp100 [280-288]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.|up to 12 months since enrollment||||participants|||Number
2849037|NCT00003224|Primary|Safety: Grade 3 Adverse Events|Adverse events are monitored according to NCI/DCT Common Toxicity Criteria|Up to 24 months after last vaccine||||participants|||Number
2849038|NCT00089999|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)|Safety Population: all randomized participants who received at least one dose of investigational product.|||Participants|||Number
2849039|NCT00089999|Secondary|Time to Treatment Failure, as Assessed by IRC and Investigator|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death due any cause. For participants who did not progress, die or discontinue early, time to treatment failure was censored at the last scan date.|From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)|ITT Population|||Weeks||95% Confidence Interval|Median
2849040|NCT00089999|Secondary|Progression-free Survival, as Assessed by the IRC and Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the IRC's and investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who did not progress, or die, progression-free survival was censored at the time of the last IRC assessed radiological scan.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)|ITT Population|||Weeks||95% Confidence Interval|Median
2849041|NCT00089999|Secondary|Duration of Response (DoR), as Assessed by the IRC and Investigator|DoR is defined for the subset of par. who had a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of >= 1 non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. For par. who did not progress or die, DoR was censored on the date of the last radiological scan. If a par.had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Weeks||Inter-Quartile Range|Median
2849042|NCT00089999|Secondary|Time to Response, as Assessed by the IRC and Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Weeks||Full Range|Median
2849043|NCT00089999|Secondary|Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator|Clinical benefit is defined as the numer of participants achieving either a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD,or complete resolution of TLs and the persistence of one or more non-TLs)or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new TLs or non-TLs and/or unequivocal progressionn of existing non-target lesions], taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)|ITT Population|||Percentage of Participants|||Number
2849044|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|ITT Population|||Participants|||Number
2849045|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of investigational product.|||Participants|||Number
2849046|NCT00089986|Secondary|Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.|Day 1 (pre-infusion) up to Day 28 Follow-up|ITT Population.|||Participants|||Count of Participants
2849054|NCT00089973|Secondary|Number of Participants With Clinical Concern Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Temperature and Heart Rate|The vital sign examination included temperature, heart rate, SBP and DBP. Participant data for clinical concern vital parameters; SBP (unit: millimeter of Mercury [mmHg]: low concern (LC) and high concern (HC) values as 90 and 180 mmHg; DBP: LC and HC values as 40 and 100 mmHg; heart rate (units: beats per minute [bpm]): LC and HC as 50 and 140 bpm; and temperature (units: degree celsius): LC and HC as 36 and 41 degree Celsius; outside the mentioned range were reported. The available data for the participants from Cycle 1 (C1) Day 1 (D1); C2D1, C3D1, C4D1, C5D1, post-treatment and any visit post-screening were reported.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population.|||Participants|||Count of Participants
2849213|NCT00089128|Primary|Response Proportion||From registration until time of complete response or partial response|Data for this endpoint was not collected||||||
2849047|NCT00089986|Secondary|Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment|Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.|Baseline (Day 1, pre-infusion) up to Day 28 Follow up|ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Participants who died prior to observing a new failure are excluded from analysis.|||Participants|||Count of Participants
2849048|NCT00089986|Secondary|Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment|The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).|Baseline (Day 1, pre-infusion) up to Day 28 Follow-up|ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Subjects who die prior to observing a new organ failure are counted as a failure.|||Participants|||Count of Participants
2849049|NCT00089986|Primary|Percentage of Participants With 28-Day All Cause Mortality|Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.|Day 1 (post-infusion) up to Day 28 Follow-up|ITT Population was defined as all randomized participants from all three stages who receive any study drug.|||Percentage of participants|||Number
2849050|NCT00089973|Secondary|PK Parameter-Volume of Distribution|The assessment of volume of distribution for SB-715992 was planned to be collected on C1D1 at timepoints; pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours. Additional samples were to be collected in subsequent cycles, only if dose of study drug was adjusted for any reason following Cycle 1. However, the data for analysis of PK parameter was not collected.|Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months|Data for PK parameter 'Volume of distribution' was not collected.||||||
2849051|NCT00089973|Secondary|Pharmacokinetic (PK) Parameter-Clearance|The assessment of clearance for SB-715992 was planned to be collected on C1D1 at timepoints; pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours. However, the data for analysis of PK parameter was not collected.|Pre-dose, and post-dose 30 minute to 1 hour, 1.5 to 2.5 hours, 4 to 6 hours and 20 to 24 hours up to Cycle 10, up to 26 months|The data for the outcome 'PK parameter-clearance' was not collected||||||
2849052|NCT00089973|Secondary|Number of Participants With Toxicity Shift Grade From Baseline for Clinical Chemistry Grade Shifts|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. A total of 45 to 46 milliliter (ml) of blood over a 21-day cycle of treatment was collected. For clinical chemistry, the parameters assessed were Alanine transaminase (ALT), Aspartate transaminase (AST), Hemoglobin, lymphocytes, neutrophils, platelet count, white blood cell (WBC), albumin, alkaline phosphatase increased, total bilirubin, calcium, creatinine, glucose, potassium and sodium. The toxicities for the clinical chemistry parameters were graded according to the NCI-CTCAE, version 3.0. where; G 0= None (normal limits); G1= Mild, G2=Moderate; G3=Severe; G4= Fatal. The number of participants with toxicity shift grades for clinical chemistry were reported.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population.|||Participants|||Count of Participants
2849053|NCT00089973|Secondary|Number of Participants With Toxicity Shift Grade From Baseline for Hematology Parameters|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. A total of 45 to 46 milliliter (ml) of blood over a 21-day cycle of treatment was collected. For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, Red blood cell count, white blood cell count (WBC), lymphocytes, monocytes, granulocytes, neutrophils, ,eosinophils and basophils. The toxicities for the hematology parameters were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. Grade (G) 0= None (normal limits); G1= Mild, G2=Moderate; G3=Severe; G4= Fatal. The toxicity shift grades for Hemoglobin, Lymphocytes, Neutrophils, platelet count and WBC, were reported.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X) in the category titles).|||Participants|||Count of Participants
2849088|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849089|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849055|NCT00089973|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|From first dose of study drug (Day 1) to 30 days after the last dose (up to 26 months)|ITT population.|||Participants|||Count of Participants
2849056|NCT00089973|Secondary|Median Time-to-progression After Administration of Inspinesib|Time-to-progression was defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The PD as per RECIST criteria 1.0 was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For participants who did not progress or die, time-to-progression was censored at the time of initiation of alternative anti-cancer therapy or time of last contact, if sooner.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population|||week||95% Confidence Interval|Median
2849057|NCT00089973|Secondary|Duration of Response|For the participants who had a CR or PR, duration of response was defined as the time a CR or PR was first documented, until the first documented sign of disease progression or death. CR for TLs was defined as disappearance of all TLs and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD. The PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For participants who did not progress or die, duration of response would be censored at the time of initiation of alternative anti-cancer therapy or time of last contact, if sooner. Due to small number of participants with a response, data was not summarized; however, individual participants data is reported week wise.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population. Only those participants available at that particular timepoints were analyzed|||Weeks|||Number
2849058|NCT00089973|Secondary|Median Time to Response|Time to response was defined as the time between the start of first dose of the study drug until the first documented evidence of partial or complete tumor response (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken as the first time the response was observed. For participants who did not show a tumor response, the time was censored at the time of withdrawal from the study for any reason. It was evaluated using RECIST criteria 1.0. CR for TLs was defined as Disappearance of all TLs and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|ITT population|||weeks||95% Confidence Interval|Median
2849059|NCT00089973|Primary|Percentage of Participants With Overall Response Rate (ORR) Following Administration of Ispinesib|Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|After cycle 2 and repeated every 2 cycles up to Cycle 10, up to 26 months|Intent to treat population consisted of all participants (n=50) who received at least one dose of study drug.|||percentage of participants|||Number
2849060|NCT00089895|Secondary|Incidence of the Composite of Death/MI.||30 days after randomization|Intent to treat population|||percentage of participants|||Number
2849061|NCT00089895|Primary|Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.||96 hours after randomization|Intent to treat population|||percentage of participants|||Number
2849062|NCT00089843|Secondary|Markers of Bone Metabolism|type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.|Baseline to 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.|||percent change of CTX||95% Confidence Interval|Mean
2849063|NCT00089843|Primary|Bone Mineral Density|Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.|Baseline and 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.|||percent change||95% Confidence Interval|Mean
2849064|NCT00089791|Secondary|Number of Participants With a Hip Fracture|Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.|36 months|Full analysis set|||Participants|||Number
2849090|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849091|NCT00089661|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849214|NCT00089102|Secondary|Progression-free Survival||Time between registration and disease progression or death, whichever comes first.|Data for this endpoint was not collected||||||
2849065|NCT00089791|Secondary|Number of Participants With Nonvertebral Fractures|Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary.|36 months|Full analysis set (all randomized participants)|||Participants|||Number
2849066|NCT00089791|Primary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).|36 months|Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used.|||Participants|||Number
2849067|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.|Baseline and after 8 weeks of treatment in ITT sample|The Intent-to-Treat Sample includes all randomized patients exposed to CPAP or Sham treatment during the post randomization treatment period.|||scores on a scale||Standard Deviation|Mean
2849068|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.|Baseline and Week 8 of treatment in ITT sample.|The Intent-to-Treat Sample includes all randomized patients exposed to CPAP or Sham treatment during the post randomization treatment period.|||scores on a scale||Standard Deviation|Mean
2849069|NCT00089752|Secondary|Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test|Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.|Baseline and 8 weeks of treatment in the ITT sample|The Intent-to-Treat Sample includes all randomized patients receiving at least a 20 minute interval of Active during the post randomization treatment period and who had no clinically significant major violations of inclusion or exclusion criteria.|||number on a scale||Standard Deviation|Mean
2849070|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States|"Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects' rate themselves as they feel today using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability."|Measured at Baseline and Week 8 treatment in the ITT sample|Population who had data post-randomization following 8 wks. intervention - ITT analysis|||scores on a scale||Standard Deviation|Mean
2849071|NCT00089752|Secondary|Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment|Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories|Measured at Baseline and Week 8 treatment in the ITT sample|Population who had data post-randomization following 8 wks. intervention - ITT analysis|||mmHg||Standard Deviation|Mean
2849072|NCT00089752|Secondary|Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale|Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness|Measured at Baseline and Week 8 of treatment in ITT sample|Participants randomized and who had post-treatment data in ITT analysis|||scores on a scale||Standard Deviation|Mean
2849073|NCT00089752|Primary|Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment|The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.|8 weeks|Consented and randomized participants who completed the FOSQ with mild or moderate obstructive sleep apnea.|||scores on a scale||Standard Deviation|Mean
2849074|NCT00089778|Primary|Immunologic Response to Peptide Vaccination Pre and Post Vaccination|FGF-5 specific CTL (cytotoxic T lymphocytes) may be tested by cytokine release assay or ELISPOT (enzyme linked immunosorbent spot) assay using tumor, FGF-5 transfected or peptide-loaded target cells and compared to pre-treatment peripheral blood mononuclear cells (PBMC) to determine immune response to vaccination. In the assays, differences of 2-3 fold are indicative of true biologic difference.Due to text data entry field limitations, Pre vaccination and post vaccination will be shown in the results as Pre V and Post V, respectively. Patients entered in Group A did not complete sufficient vaccinations to permit immunological evaluation and in Group B, the co-administration of IL-2 is known to corrupt immunological evaluation (so only clinical responses are valid). Expanding information on cancer vaccines in general as wells as preliminary information from this trial on FGF-5 as a vaccine target both served to render the enrollment of additional patients to this trial obsolete.|24 hours|“1 uM A3 culture vs tranfectant” means “Immune cells cultured with the concentration of 1 uM of the A3 peptide were tested against [with] target cells into which the FGF-5 target gene was inserted [transfected with] and the release of interferon is measured to detect immune recognition”.Documentation was only available for the 4 patients.|||pg/ml/24 hrs|||Number
2849075|NCT00089778|Primary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|47 months||||Participants|||Count of Participants
2849076|NCT00089778|Primary|Response|Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|3 years and 9 months|Pts in Group C had no evaluable disease,response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).|||Participants|||Count of Participants
2849077|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 24|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|24 months|Full analysis set|||Participants|||Number
2849078|NCT00089674|Secondary|Time to First Clinical Fracture Through Month 36|A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.|36 months|Full analysis set|||Percentage of participants|||Number
2849079|NCT00089674|Secondary|Number of Participants With a New Vertebral Fracture Through Month 36|New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.|36 months|All randomized subjects who have a baseline and >= 1 postbaseline evaluation of vertebral fracture at or before 3 years.|||Participants|||Number
2849080|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 36|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|36 months|Full analysis set|||Participants|||Number
2849081|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849082|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849083|NCT00089674|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849084|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849085|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849086|NCT00089674|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849087|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months||||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
2849095|NCT00089648|Secondary|Plasma Concentration of Placental Growth Factor (PlGF)|Plasma concentrations of PlGF that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT|||pg/mL||Full Range|Mean
2849096|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT|||pg/mL||Full Range|Mean
2849097|NCT00089648|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)|Plasma concentrations of VEGF-A that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT|||pg/mL||Full Range|Mean
2849098|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)||Day 28 of Cycle 1 to Cycle 4|ITT|||ng/mL||Full Range|Median
2849099|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of SU012662||Day 28 of Cycle 1 to Cycle 4|ITT|||ng/mL||Full Range|Median
2849100|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Sunitinib||Day 28 of Cycle 1 to Cycle 4|ITT|||ng/mL||Full Range|Median
2849101|NCT00089648|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from start of study medication to first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.|||weeks||Full Range|Median
2849102|NCT00089648|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to date of death due to any cause. OS (in weeks) was calculated as [date of death minus first dose date +1]/7. For a subject not expiring, the OS time was censored on the last date of known contact that they were known to be alive. Subjects lacking data beyond the day of the first dose had their OS times censored at 1 day. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT|||weeks||95% Confidence Interval|Median
2849103|NCT00089648|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was only calculated for the subgroup of subjects with a confirmed objective response. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT subjects (i.e, all subjects enrolled in the study that received at least 1 dose of study medication) who had a confirmed CR or PR. 14 subjects who had a response were analyzed for DR.|||weeks||95% Confidence Interval|Median
2849104|NCT00089648|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of the first documentation of tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.|||weeks||95% Confidence Interval|Median
2849105|NCT00089648|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|Intent-to-treat (ITT)=all subjects enrolled in the study that received at least 1 dose of study medication.|||participants|||Number
2849106|NCT00089635|Secondary|Overall Survival|Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||months||95% Confidence Interval|Median
2849107|NCT00089635|Secondary|Duration of Stable Disease|"Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.~Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started."|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.|||weeks||95% Confidence Interval|Median
2849138|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||mL/min||95% Confidence Interval|Geometric Mean
2849108|NCT00089635|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.|||weeks||95% Confidence Interval|Median
2849109|NCT00089635|Secondary|Time to Disease Progression|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||weeks||95% Confidence Interval|Median
2849110|NCT00089635|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||weeks||95% Confidence Interval|Median
2849111|NCT00089635|Secondary|Time to Initial Objective Response|Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.|||weeks||Full Range|Median
2849112|NCT00089635|Secondary|Objective Tumor Response Throughout the Study|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||participants|||Number
2849113|NCT00089635|Primary|Duration of Response|Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.|||weeks||95% Confidence Interval|Median
2849114|NCT00089635|Primary|Objective Tumor Response Through Week 16|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment through Week 16|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).|||participants|||Number
2849115|NCT00089583|Secondary|Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population||||||
2849116|NCT00089583|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire|The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2849139|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||mL/min/kg||95% Confidence Interval|Geometric Mean
2849117|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Week 60 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable|||Participants|||Number
2849118|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through 48 Weeks|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable|||participants|||Number
2849119|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|After Week 48 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.|||Participants|||Number
2849120|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.|||participants|||Number
2849121|NCT00089583|Secondary|Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Week 2, 12, 24, 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
2849122|NCT00089583|Secondary|Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
2849123|NCT00089583|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||cells/cu mm||Inter-Quartile Range|Median
2849140|NCT00089583|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
2849124|NCT00089583|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.|||Cells per cubic millimeter (cells/cu mm)||Inter-Quartile Range|Median
2849125|NCT00089583|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||participants|||Number
2849126|NCT00089583|Secondary|Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||log10/copies||Inter-Quartile Range|Median
2849127|NCT00089583|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||log10 copies/mL||Inter-Quartile Range|Median
2849128|NCT00089583|Secondary|Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 2, 12, 24, and 48|Intent-to-Treat Exposed (ITT-E) Population. Only those par. contributing data at the indicated time points were analyzed. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||participants|||Number
2849129|NCT00089583|Secondary|Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study.|Week 48|Intent-to-Treat Exposed (ITT-E) Population: par. with documented evidence of receiving >=1 treatment dose. Only par. contributing data were analyzed. The number of par. analyzed is the sum of the PI-naïve (received <1week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.|||participants|||Number
2849130|NCT00089583|Secondary|Plasma FPV t1/2|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2849131|NCT00089583|Secondary|Plasma FPV Tmax|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2849132|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2849133|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2849134|NCT00089583|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2849135|NCT00089583|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2849136|NCT00089583|Secondary|Plasma RTV t1/2|alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||hours||95% Confidence Interval|Geometric Mean
2849137|NCT00089583|Secondary|Plasma RTV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||hours||Full Range|Median
2849141|NCT00089583|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
2849142|NCT00089583|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data were analyzed.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
2849143|NCT00089583|Primary|Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities|"A toxicity was considered TE if it was > than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells [WBCs]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is severe; Grade 4 is potentially life-threatening. ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count."|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2849144|NCT00089583|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48|Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.|||International units per liter (IU/L)||Inter-Quartile Range|Median
2849145|NCT00089583|Primary|Change From Baseline in Serum Lipase at Week 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.|||Units per liter (U/L)||Inter-Quartile Range|Median
2849146|NCT00089583|Primary|Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48|Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.|||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
2849147|NCT00089583|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.|||participants|||Number
2849148|NCT00089583|Primary|Plasma APV t1/2|The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Only those participants contributing data were analyzed.|||hours||95% Confidence Interval|Geometric Mean
2849149|NCT00089583|Primary|Plasma APV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.|Week 48|PK Population. Only those participants contributing data were analyzed.|||hours||Full Range|Median
2849150|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.|||Milliliters per minute (mL/min)||95% Confidence Interval|Geometric Mean
2849151|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
2849152|NCT00089583|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2849153|NCT00089583|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2849165|NCT00089609|Primary|Number of Participants Who Had a Prostate-specific Antigen (PSA) Response|PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.|21.6 months|The main cohort was designed to evaluate clinical progression and the expansion cohort was designed to evaluate immune response. Thus the expansion cohort is not included here.|||Participants|||Count of Participants
2849166|NCT00089544|Secondary|Response to Pre-operative Therapy Assessed Using RECIST Criteria||From start of treatment to time of surgery.|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."||||||
2849154|NCT00089583|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
2849155|NCT00089609|Secondary|Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab||Baseline and monthly|The outcome was not assessed. In the study, assessment of circulating apoptotic endothelial cells was the main outcome evaluated for assessing the treatment's antiangiogenic activity. Changes in the molecular markers of angiogenesis will not be pursued.||||||
2849156|NCT00089609|Secondary|Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer|Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions.|Baseline and at 3 month intervals until progression|The outcome was not assessed as the functionality of dynamic MRI in prostate cancer was poor at the time of this study. Earlier prostate MRI techniques suffered from poor sensitivity and specificity for monitoring progression.||||||
2849157|NCT00089609|Secondary|Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy|Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated.|Patient entry onto the study|The outcome was not assessed as the clinical significance of cytochrome P450 2C19 polymorphism in angiogenesis is undetermined. This analysis will not be pursued.||||||
2849158|NCT00089609|Secondary|Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level|"The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, significant increase is dependent upon this comparison and varies between patients."|Baseline and at 6 weeks (after two cycles of treatment)|Only 17/60 participants were evaluable for this outcome. Per protocol CAECs were not assessed in the expansion cohort.|||Participants|||Count of Participants
2849159|NCT00089609|Secondary|Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity|The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection.|Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion|The outcome was not assessed as the analysis of plasma bevacizumab concentrations was the main pharmacokinetic secondary outcome in the study. The plasma levels of docetaxel and thalidomide (without bevacizumab) had minimal significance in this study. Analysis of plasma concentrations of docetaxel and thalidomide will not be done.||||||
2849160|NCT00089609|Secondary|Number of Participants Who Died After a Follow Up of 34 Months Following Treatment|From on study date to date of death at 34 months.|34 months|Per protocol, this outcome was not assessed for the expansion cohort.|||Participants|||Count of Participants
2849161|NCT00089609|Secondary|Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)|Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions.|up to 34 months|"Only 33/60 participants had measurable disease and were evaluable for this outcome measure.~Per protocol, disease progression by clinical and radiographic criteria without the use of PSA was not assessed for the expansion cohort."|||Participants|||Count of Participants
2849162|NCT00089609|Secondary|Time to Progression Using Bubley Criteria|Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.|up to 40 months|Per protocol, time to progression using Bubley Criteria was not assessed for the expansion cohort.|||Months||95% Confidence Interval|Median
2849163|NCT00089609|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|37 months||||Participants|||Count of Participants
2849164|NCT00089609|Primary|Immune Response|Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication.|6 weeks|Cellular immune response and cytokines were not analyzed as the study outcomes were concentrated on the dual-anti-angiogenesis inhibition properties of the regimen and not immunomodulatory changes.||||||
2849203|NCT00089141|Secondary|Death or Recurrent Malignancy|Death due to any cause or development of recurrent malignancy at any time after enrollment|within 4 years||||participants|||Number
2849167|NCT00089544|Secondary|Wound Complication (Grades 2, 3, 4, and 5) as Measured by CTCAE v3.0|Will be estimated using a binomial distribution and accompanied by the associated 95% confidence interval.|From start of treatment to time of surgery|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."||||||
2849168|NCT00089544|Primary|Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation|Was to be estimated using a binomial distribution and accompanied by the associated 95% confidence interval. Due to early study closure, this endpoint could not be fully evaluated per the protocol plan.|Duration of treatment (which can continue up to approximately 15 months).|Eligible patients who started study treatment.|||participants|||Number
2849169|NCT00089505|Secondary|Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month|Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use as-treated approach.|||percent of participants|||Number
2849170|NCT00089505|Secondary|Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality|Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.|Numbers presented use the as-treated approach.|||participants|||Number
2849171|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.|The analysis was intent to treat per protocol.|||weeks||95% Confidence Interval|Number
2849172|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||weeks||95% Confidence Interval|Number
2849173|NCT00089505|Secondary|Number of Participants Who Experienced HIV-related Disease Progression or Death|Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||participants|||Number
2849174|NCT00089505|Secondary|Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.|The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use as-treated method.|||participants|||Number
2849175|NCT00089505|Secondary|CD4 Count Change From Randomization|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.|Changes were calculated using the intent-to-treat approach (i.e. ignoring changes from randomized treatment) but no imputation was done for missing values.|||cells/mm^3||Inter-Quartile Range|Median
2849176|NCT00089505|Secondary|Percent of Participants Who Experienced Virologic Failure or Died|Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||Percent of participants||95% Confidence Interval|Number
2849204|NCT00089141|Secondary|Non-relapse Mortality|Death without prior development of recurrent malignancy|within 4 years||||participants|||Number
2849205|NCT00089141|Secondary|Recurrent Malignancy|Development of recurrent malignancy after enrollment in the study|within 4 years||||participants|||Number
2849177|NCT00089505|Secondary|Number of Participants Who Experienced Virologic Failure or Died.|Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).|||participants|||Number
2849178|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Time to Event]|Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
2849179|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
2849180|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event|Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
2849181|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
2849182|NCT00089479|Secondary|Breast Cancer Free Survival [Time to Event]|Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
2849183|NCT00089479|Secondary|Breast Cancer Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.|Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .|Intent−to−Treat Population|||participants|||Number
2849184|NCT00089479|Secondary|Overall Survival [Time to Event]|Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
2849185|NCT00089479|Primary|Disease Free Survival [Time to Event]|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||months||95% Confidence Interval|Median
2849186|NCT00089479|Secondary|Overall Survival [Number of Events]|Number of patients who died/were alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
2849187|NCT00089479|Primary|Disease Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population|||participants|||Number
2849188|NCT00089414|Secondary|Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms|"The Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Total scores are interpreted per these ranges:~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression."|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.||||||
2849189|NCT00089414|Primary|Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.|The PMTS observer scales assess symptoms in ten different domains including irritability-hostility; tension; efficiency; dysphoria; moodiness; motor coordination; mental-cognitive functioning; eating habits; sexual drive and activity; physical symptoms and social impairment. They have been used to measure premenstrual symptom severity and response to treatment in several clinical trials and prevalence studies. Score ranges from no symptoms to severe symptoms on a scale of 0 to 6, with 0 being no symptoms and 6 being severely symptomatic.|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.||||||
2849190|NCT00089414|Secondary|Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.|The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication.1 The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI actually comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale, with 1 being normal/more improved and 7 being severe/worse.|Every 2 wks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior.||||||
2849191|NCT00089297|Secondary|Overall Survival|Overall survival is defined as the time from registration to death of any causes.|Weekly during treatment, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.|||Months||95% Confidence Interval|Median
2849192|NCT00089297|Secondary|Progression-free Survival|Progression-free survival was defined as the time from registration to documented progression or death without progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.|||Months||95% Confidence Interval|Median
2849193|NCT00089297|Secondary|Proportion of Patients With Objective Response by RECIST|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in this analysis.|||proportion of patients||95% Confidence Interval|Number
2849194|NCT00089297|Primary|Event-free Survival Rate at 1 Year|Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.|Assessed at 1 year.|Only eligible patients are included in the analysis.|||proportion of patients||95% Confidence Interval|Number
2849195|NCT00089284|Secondary|Correlative Laboratory Studies|To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations).|On Day 1 and 4|Data not collected for analysis of this outcome measure.||||||
2849196|NCT00089284|Secondary|Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs|To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement.|At baseline (pre-treatment) and on Day 4 of treatment|Data was not collected for analysis of this outcome measure due to lack of funding.||||||
2849197|NCT00089284|Secondary|Anti-lymphoma Efficacy|To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined.|At 1, 3 and 6 months|All phase I and phase II patients were evaluated for response to treatment (anti-lymphoma efficacy). For the cohort with ≤ 5% bone marrow involvement treated at the 5.0 mg/kg MGd dose, results are based on 6 phase I patients and 8 phase II patients. 2 patients were determined not to be evaluable as they did not reach response time points.|||Participants|||Count of Participants
2849198|NCT00089284|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients.|Weekly during treatment and continuing up through Day 90|Phase I arms were evaluable for this outcome measure.|||mg/kg|||Number
2849199|NCT00089284|Primary|Dose Limiting Toxicities (DLT)|"The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients.~All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following:~Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days—Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively)."|Weekly during treatment and continuing up through Day 90|Only patients enrolled during the phase I portion of this trial were analyzed for this outcome measure.|||Dose-Limiting Toxicities|||Number
2849200|NCT00089141|Secondary|End of Systemic Treatment|Withdrawal of all immunosuppressive treatment without recurrent malignancy|within 4 years||||participants|||Number
2849201|NCT00089141|Secondary|Withdrawal of Prednisone|Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD|within 4 years||||participants|||Number
2849202|NCT00089141|Secondary|Death|Death from any cause after enrollment in the study|within 4 years||||participants|||Number
2849218|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for the Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4-||Standard Error|Mean
2849219|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4+||Standard Error|Mean
2849220|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4-||Standard Error|Mean
2849221|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.|||percentage of change of CD3+CD4+||Standard Error|Mean
2849222|NCT00089076|Secondary|Duration of Response (Phase 2)|Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.|From response to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.||||||
2849223|NCT00089076|Secondary|Overall Survival (Phase 2)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|From registration to death (up to 2 years)|No participants proceeded to Phase 2 for evaluation.||||||
2849224|NCT00089076|Secondary|Time to Progression (Phase 2)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From registration to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.||||||
2849225|NCT00089076|Primary|Number of Overall Confirmed Responses(Complete Response or Partial Response)|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|From registration to month 7||||participants|||Number
2849226|NCT00089024|Primary|Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment|Toxicity event collected during Induction chemotherapy (CT) - two 3-week cycles, Concurrent CT and Radiation Therapy (CRT) (approximately 5.5 weeks), post CRT (4 weeks after the end of CRT), 2-3 months post CRT (8-12 weeks after the end of CRT)|From time of first dose until 30 days following final treatment, approximately 24 weeks|A total of 29 patients started induction CT. Two patients dropped out because of progressive disease (PD) and 1 died from pulmonary embolus. 27 patients continued with CRT 24 (89%) received the full radiation dose. Of 24, 5 went off study prior to surgical exploration, for remaining 19 with surgical exploration.|||Participants|||Count of Participants
2849227|NCT00089024|Primary|Surgical Exploration|Patients who completed chemotherapy & chemo-radiation had restaging imaging studies 4 weeks after completion of chemo-radiation. If there were no contraindications for surgical resection, surgical exploration was performed 6-8 weeks after completing chemo-radiation|After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.|Only 19 participants under went surgical exploration.|||Participants|||Count of Participants
2849228|NCT00089011|Secondary|Rate and Duration of Steroid Use for the Treatment of Chronic GVHD|Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.|Up to 5 years|Only those patients who received steroids for treatment of chronic GVHD.|||days||Full Range|Median
2849229|NCT00089011|Secondary|Rates of Relapse-related Mortality|Number of patients who expired with relapsed/progressive disease.|Up to 5 years||||Participants|||Count of Participants
2849230|NCT00089011|Secondary|Rates of Disease Progression|"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|Up to 5 years||||Participants|||Count of Participants
2849243|NCT00088881|Secondary|3-year Overall Survival (OS) Rate|Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
2849231|NCT00089011|Secondary|Incidences of Grades II-IV Acute GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 180 post-transplantation||||Participants|||Count of Participants
2849232|NCT00089011|Secondary|Overall Survival|Number of patients surviving post-transplant.|At 1 year after conditioning||||Participants|||Count of Participants
2849233|NCT00089011|Secondary|Incidences of Graft Rejection|Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.|Day 180 post-transplantation||||Participants|||Count of Participants
2849234|NCT00089011|Primary|Incidence of Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Day 180 post-transplantation||||Participants|||Count of Participants
2849235|NCT00089011|Primary|Incidence of Grade III/IV GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 180 post-transplantation||||Participants|||Count of Participants
2849236|NCT00088985|Secondary|Immune Response|Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy.|3 months following treatment||||Participants|||Count of Participants
2849237|NCT00088985|Primary|Overall Response Rate|"Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response)~Complete Response (CR)− Disappearance of all target lesions~Partial Response (PR)−at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter."|6 months following treatment||||Participants|||Count of Participants
2849238|NCT00088972|Secondary|Ki-67 Expression|The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).|1 year|Since the study was closed early due to insufficient accrual, the ki-67 data were never collected.||||||
2849239|NCT00088972|Primary|Mammographic Density|The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.|1 year|Counts represent number of patients for by arm for whom a 1 year mammographic density image was submitted. However, since the study was closed early due to poor accrual, there was insufficient accrual to evaluate study endpoints, and these images were never analyzed.||||||
2849240|NCT00088907|Secondary|Overall Response Rate|"Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.~Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).~All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2849241|NCT00088907|Secondary|Time to Progression|"Time to progression is defined as time from registration to disease progression. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .~Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).~All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients|||months||95% Confidence Interval|Median
2849242|NCT00088907|Primary|Overall Survival|Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients|||months||95% Confidence Interval|Median
2849244|NCT00088881|Secondary|3-year Time to Treatment Failure (TTF) Rate|Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.|Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients|||probability||95% Confidence Interval|Number
2849245|NCT00088881|Primary|Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients.|||proportion of participants||95% Confidence Interval|Number
2849246|NCT00088881|Primary|Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2849247|NCT00088829|Primary|Overall Response|Due to the early termination of the study, this data for this outcome was not collected.|3 months|||||||
2849248|NCT00088699|Primary|MADRS Score - Day 1 Following Intervention|Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|Day 1|The analyses included subjects who were given Ketamine or Placebo.|||units on a scale||Standard Deviation|Mean
2849249|NCT00088699|Primary|MADRS Score - Baseline|Antidepressant effects were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|Baseline|The analyses included subjects who were given Ketamine or Placebo.|||units on a scale||Standard Deviation|Mean
2849250|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.|||units on scale||95% Confidence Interval|Least Squares Mean
2849251|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2849252|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS|||units on a scale||95% Confidence Interval|Least Squares Mean
2849253|NCT00088634|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score|"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately."|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2849254|NCT00088621|Primary|Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study||1 year|Number of subjects that entered into the extension trial.|||participants|||Number
2849255|NCT00088595|Secondary|The Overall Safety and Tolerability of Pasireotide|Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.|At least 15 days|The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population.|||Participants|||Number
2849256|NCT00088595|Secondary|The Number of Patients (Participants) With Overall Tumor Response|The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.|At least 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.|||Participants|||Number
2849257|NCT00088595|Secondary|Duration of Partial Symptom Control (Days) by Dose Class|Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.|up to 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control|||Days||Standard Deviation|Mean
2849258|NCT00088595|Secondary|Duration of Complete Symptom Control (Days) by Dose Class|Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control.|||Days||Standard Deviation|Mean
2849259|NCT00088595|Primary|Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary|"Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.~Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.~Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level."|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.|||participants|||Number
2849260|NCT00088530|Secondary|Overall Response Rate (ORR) Lasting at Least 4 Months|The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.|approximately 24 months|Intent-To-Treat (ITT) population|||participants|||Number
2849261|NCT00088530|Secondary|Overall Survival|The time between the date of randomization and the date of death due to any cause.|18 months after 6 cycles of treatment; approximately 24 months|Intent-To-Treat (ITT) Population.|||Months||95% Confidence Interval|Median
2849262|NCT00088530|Secondary|Progression-Free Survival (PFS)|The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.|18 months after 6 cycles of treatment; approximately 24 months|Intent-to-treat patients|||months||95% Confidence Interval|Median
2849263|NCT00088530|Primary|Complete Response (CR) and Complete Response Unconfirmed (CRu)|Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)|EOT; approximately 6 months|Intent to Treat (all randomized patients)|||percentage of randomized patients||95% Confidence Interval|Number
2849264|NCT00088465|Primary|Number of Participants With Extrapyramidal Symptoms at Any Time|Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.|Randomization to end of study up to 76 months|Participants with a baseline and at least one post-baseline measurement.|||participants|||Number
2849265|NCT00088465|Primary|Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint|PCS weight gain is defined as a ≥7% increase in weight from baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
2849266|NCT00088465|Primary|Change From Baseline in Weight at Month 76 Endpoint|Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||kilogram (kg)||Standard Deviation|Mean
2849267|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline|Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
2850095|NCT00002597|Primary|Overall Survival Rate (10-year)|Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.|From date of randomization to 10 years|All eligible patients.|||percentage of patients||95% Confidence Interval|Number
2849268|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline|Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
2849269|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline|High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
2849270|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline|Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.|||participants|||Number
2849271|NCT00088465|Secondary|Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year|Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).|Randomization to end of study up to 76 months|Participants who took at least one dose of study drug and had post-baseline measurements.|||(ng/mL)/(mg/day)||Standard Deviation|Mean
2849272|NCT00088465|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint|Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.|Randomization to end of study up to 76 months|All randomized participants.|||percent of participants|||Number
2849273|NCT00088465|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint|The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849274|NCT00088465|Secondary|Days of Hospitalization|This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.|||days|||Number
2849275|NCT00088465|Secondary|Number of Psychiatric Visits|Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.|||visits|||Number
2849276|NCT00088465|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849277|NCT00088465|Secondary|Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint|Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849278|NCT00088465|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, up to 72 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Error|Mean
2849279|NCT00088465|Secondary|Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint|PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849280|NCT00088465|Secondary|Change From Baseline in PANSS Negative Scores at Month 76 Endpoint|PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849281|NCT00088465|Secondary|Change From Baseline in PANSS Positive Scores at Month 76 Endpoint|PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849282|NCT00088465|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2849283|NCT00088465|Primary|Number of Participants With Adverse Events (AE)|The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.|||participants|||Number
2849284|NCT00088413|Secondary|Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination|Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.|post vaccination (up to Day 84)|Only 3 Breast Cancer and 2 Ovarian Cancer patients had enough blood collected to perform enzyme-linked immunospot (ELISPOT) analysis.|||Participants|||Count of Participants
2849285|NCT00088413|Secondary|Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination|Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.|post vaccination (up to Day 84)|Overall number of participants analyzed reflects participants that are HLA-A2 positive.|||Participants|||Count of Participants
2849286|NCT00088413|Secondary|Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date consent signed to date off study, approximately 164 months and 10 days|Pts in these 2 cohorts rec'd the same treatment, have absence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small cohorts, a better est. of the true event rate can be determined by grouping the pts in the absence of a biological rationale and is consistent with the peer-reviewed clinical paper.|||Participants|||Count of Participants
2849287|NCT00088413|Secondary|Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts|Vaccines were administered to participants and Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. Common Terminology Criteria in Adverse Events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Approximately 2 months while on trial|The breast and ovarian cohorts received the same treatment on the same schedule, had no evidence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small trial arms, the true event rate is better determined by grouping similar patients and is consistent with the peer-reviewed clinical paper.|||percentage of participants|||Number
2849288|NCT00088413|Primary|Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group|Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Approximately 6 months while on trial|The colorectal and non-colorectal cohorts received the same treatment on the same schedule, had no immune dysfunction at baseline and are biologically equivalent. For rare events in small cohorts, a better estimate of the true event rate is determined by grouping similar patients and is consistent with the peer-reviewed clinical paper.|||Percentage of vaccines|Vaccines administered||Number
2849300|NCT00088166|Secondary|Change From Baseline in the FACT-Br Quality of Life Results|The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)|Prospective|Intent to Treat; LOCF|||Scores on a scale||Standard Deviation|Mean
2849289|NCT00088413|Primary|Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all clinical and laboratory signs and symptoms of disease for a minimum of 4 weeks during which no new lesions may appear. Partial Response is a minimum of 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable disease is neither sufficient shrinkage to qualify for partial response nor progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.|Approximately 6 months while on trial||||Participants|||Count of Participants
2849290|NCT00088374|Secondary|Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor|Dynamic images will be acquired before and after the intravenous administration of 0.1 mmol/kg of Gadolinium Diethylene triamine pentaacetic acid (DTPA). Time activity curves will be generated over a period of ten minutes. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters we had previously defined (Ktrans, Kep, etc.).|Baseline and during therapy (12 weeks)|It is not the magnitude of changes in Ktrans, Kep, and Ve that limit our abililty, but the fact that this data was available in only a small number of patients.|||participants with changes|||Number
2849291|NCT00088374|Secondary|Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake|Images were acquired after the intravenous administration of 18FDG and H2015 and used to analyze glucose uptake and estimate blood flow. The parameter to be measured is SUV (standard uptake value(s)) and/or mL/min/gm.|Baseline and at 12 weeks|Response was not the endpoint. The SUV values were in the 2-3 range and hence renal tumors could not be clearly identified by this technique in any of the patients.|||participants|||Number
2849292|NCT00088374|Secondary|The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes|Measurement of HIF, HSP90 and HSP70 levels by Western Blot in tumor tissue and/or lymphocytes to assess modulation of these biomarkers in response to 17 AAG treatment. Pretreatment tumor samples (when available) and resected tumors (in those patients who did not have a response and underwent surgical resection of their tumor) were to be used for this analysis. Levels of Hsp90, Hsp70, HIF and HIF transcriptional targets in resected tumor will be compared to respective levels in tumors previously resected from other VHL patients (not treated with 17AAG).|Baseline and 12 weeks|This analysis was not performed as it was felt that there were not a sufficient number of samples to enable a meaningful analysis.||||||
2849293|NCT00088374|Secondary|The Number of Participants With Adverse Events|"Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. For a detailed description see the link in the Protocol Link module."|1 yr, 364 days||||participants|||Number
2849294|NCT00088374|Secondary|Number of Participants With a Non-renal Tumor Response|Number of patients who have a PR or CR of non-renal lesions (pancreatic tumors, pheochromocytomas, and hemangioblastomas). The effect of treatment on the lesions will be evaluated at baseline and at the time of restaging (12 weeks) per RECIST criteria. RECIST is defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesions. Lesions are either measurable or non-measurable using the criteria. See the protocol Link module for the full criteria if desired.|Baseline and 12 weeks|There were only two patients with measurable nonrenal tumors and hence the number of participants analyzed is correct.|||participants|||Number
2849295|NCT00088374|Primary|Number of Participants With a Renal Tumor Response|Response is defined as the number of patients who experience a disease response (complete response (CR) or partial response (PR) of renal tumors)per RECIST criteria. CR is the disappearance of all target lesions. PR is at least a 20% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. See the protocol Link module for the full criteria if desired.|12 weeks|8 patients were evaluable (received at least one dose of drug and had a follow up scan).|||participants|||Number
2849296|NCT00088218|Primary|Number of Participants With Response|"Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.'~Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 109/L and platelet count > 100 x 109/L, and normal bone marrow differential (< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 109/L.~Blood draws once a week until remission then every 2 to 8 weeks during therapy."|Every 2 to 8 weeks|All treated subjects.|||Participants|||Number
2849297|NCT00088166|Secondary|Number of Patients Who Discontinued Study Drug Prior to the End of Week 5|Numbers of patients who discontinued prior to the Week 5 assessment|Prospective|Intent to Treat population|||participants|||Number
2849298|NCT00088166|Secondary|Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study|The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.|Prospective|Intent to Treat population; baseline observation carried forward|||Percent dexamethasone dose reduction||Standard Deviation|Mean
2849299|NCT00088166|Secondary|Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)|Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).|Prospective||||Scores on a scale||Standard Deviation|Mean
2849620|NCT00084838|Other Pre-specified|Grade 3-4 Blood/Bone Marrow Events|"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.~Arm Name"|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849301|NCT00088166|Secondary|Change From Baseline in the Karnofsky Performance Score|"Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment nec"|Prospective|Intent to Treat population|||Scores on a scale||Standard Deviation|Mean
2849302|NCT00088166|Secondary|Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)|Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.|Prospective|Intent to Treat population|||Scores on a scale||Standard Deviation|Mean
2849303|NCT00088166|Secondary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8|• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.|Prospective|Intent to Treat Population|||participants|||Number
2849304|NCT00088166|Secondary|Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS||Prospective|Intent to Treat Population|||participants|||Number
2849305|NCT00088166|Primary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5|"The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:~50% or greater reduction in dexamethasone dose relative to Baseline~Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline~Karnofsky Score unchanged or increased relative to Baseline"|Prospective|Intent to Treat Population|||participants|||Number
2849306|NCT00088153|Primary|Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.~The other primary outcome was the change in spine bone density Z-score from baseline to 18 months. The bone density Z-score is a standard deviation score that compares one's bone density to the mean for age and gender, and the Z-score, therefore, does not have any units. It is simply referred to as a Z-score. Change in bone density Z-score= [Bone density Z-score at 18 months- Bone density Z-score at baseline]"|Baseline and 18 months||||Z -scores||Standard Deviation|Mean
2849307|NCT00088153|Secondary|Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)|"P1NP is a surrogate marker of bone formation that is measured in serum. P1NP levels were measured at baseline, 6, 12 and 18 months.~A secondary outcome was the change in P1NP levels from baseline to 18 months: [P1NP at 18 months - P1NP at baseline). The unit is ng/ml"|Baseline and 18 months|The number of participants was determined based on our preliminary data. This analysis was based on completers only.|||ng/ml||Standard Deviation|Mean
2849308|NCT00088153|Primary|Percent Change in Spine Bone Density Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.~The primary outcome was the percent change in bone density at the spine from baseline to 18 months. Areal bone density is measured as g/cm2. The unit of measure for the percent change in bone density is 'percent' Percent change in bone density= [[Bone density at 18 months- Bone density at baseline)*100/Bone density at baseline]%"|Baseline and 18 months|The number of participants was determined using power calculations based on preliminary data. For our primary longitudinal analysis, bone mineral density (BMD) changes were analyzed using a mixed model analysis of variance (intent-to-treat model). For secondary analysis, we examined BMD changes after controlling for age and weight changes.|||Percent change||Standard Deviation|Mean
2849309|NCT00087698|Secondary|Overall Survival Time|Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).|baseline to date of death from any cause|All participants who had undergone surgery.|||months||Full Range|Mean
2849310|NCT00087698|Secondary|Time to Progressive Disease|Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.|baseline to measured progressive disease|All participants who had undergone surgery.|||months||Full Range|Mean
2849311|NCT00087698|Secondary|Time to Treatment Failure|Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.|baseline to stopping treatment|All participants who had undergone surgery.|||months||Full Range|Mean
2849312|NCT00087698|Secondary|Overall Tumor Response|The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.|baseline to measured progressive disease|Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.|||participants|||Number
2849313|NCT00087698|Secondary|The 1 and 2 Year Disease-Free Survival Rate (Percentage)|Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.|1 year and 2 years|All participants who had undergone surgery.|||percentage of participants||95% Confidence Interval|Mean
2849314|NCT00087698|Primary|Pathological Complete Response|"Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]).~Resected tissue or pleural fluid should be sent for pathological and histological evaluation."|Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)|All participants who had undergone surgery.|||participants|||Number
2849315|NCT00087685|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).|20 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.|||percentage of participants||95% Confidence Interval|Number
2849316|NCT00087685|Primary|Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)|Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|8 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.|||participants|||Number
2849317|NCT00087672|Primary|Efficacy of CC-5013 in Myelofibrosis|"Response evaluation, sustained for 2 weeks: Complete Remission (Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow); Partial Hematologic Response/Partial Remission (Increase in neutrophil by 50% + above 10^9/L for neutropenia); Hematologic Improvement (increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts) or No Response.~If nine or < patients respond to therapy (response other than 'No Response'), therapy declared ineffective. However, if 11 or > patients respond to therapy, therapy considered efficacious."|3 - 4 Months for all patients; 24 months for responders|Intention to treat: After a total of 41 patients were enrolled in study, nine or more patients responded to the therapy, therapy declared effective.|||Participants|||Number
2849318|NCT00087646|Secondary|Percentage of Participants With Relapse After End of Treatment|The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2849319|NCT00087646|Secondary|Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response|Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2849320|NCT00087646|Secondary|Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)|The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.|At Week 12 and 24|ITT population included all participants randomized who received at least one dose of study medication.|||IU/ML||95% Confidence Interval|Mean
2849321|NCT00087646|Secondary|Percentage of Participants With >=2log Drop in HCV-RNA|Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.|At Week 12 and 24|ITT population included all the participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2849322|NCT00087646|Secondary|Percentage of Participants With Undetectable HCV-RNA|"The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.~End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days)."|At Week 12, 24, 48 and EOT|ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
2849323|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.|||participants|||Number
2849324|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.|||participants|||Number
2849325|NCT00087646|Primary|Number of Participants With Sustained Virological Response Rate|Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|Up to 72 weeks (Group A) and 48 weeks (Group D)|Intent-to-treat analysis population (ITT) included, all participants randomized who received at least one dose of study medication.|||participants|||Number
2849326|NCT00087633|Secondary|Summary of Virologic Response|Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.|After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up|ITT population|||participants|||Number
2849327|NCT00087633|Primary|Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)|"Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2.~Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe.~Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis."|120 weeks postrandomization|Intent-to-treat population|||percentage of participants|||Number
2849328|NCT00087607|Secondary|Weekly AUC for IFN Concentrations for Pegasys and PEG-Intron Estimated by Population Pharmacokinetic Modeling|The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned through population pharmacokinetic modeling. A population pharmacokinetic method deals with modelling in a cohort which has many participants (usually more than 40). The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned to be studied in the population rather than the individuals in Peginterferon alfa-2a + Ribavirin and Peginterferon alfa-2b + Ribavirin groups.|Up to Week 8|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.||||||
2849329|NCT00087607|Secondary|Percentage of Participants With Each of the Identified HCV Quasispecies at Baseline and Weeks 1, 4, 8, and 12|The determination of evolution of HCV quasispecies in participants was planned through analyzing viral sequences in serum samples drawn at baseline and at Weeks 1, 4, 8, and 12 if HCV RNA tests were positive and if the levels were sufficient to do the analysis.|Baseline, Weeks 1, 4,8, and 12|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.||||||
2849330|NCT00087607|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
2849331|NCT00087607|Secondary|Area Under the Curve for Interferon in the Frequent-Sampling Cohort|Area Under the Curve (AUC) for Interferon (IFN) for Week 1 and Week 8 in the frequent-sampling cohort were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants assessed for AUC for Interferon for specified time point.|||week*pg/mL||Standard Deviation|Mean
2849332|NCT00087607|Secondary|Mean Trough Interferon Concentrations at Each Week|The weekly Interferon (IFN) concentrations were calculated using the trapezoid rule. The trough IFN concentration was analyzed using an enzyme-linked immunosorbent assay (ELISA), with limits of quantification of 250 picograms per milliliter [pg/mL] for Pegasys and 150 pg/mL for PEG-Intron respectively.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||pg/mL||Standard Error|Mean
2849333|NCT00087607|Secondary|Number of Participants With Marked Abnormalities in Thyroid Function Tests|Values outside the marked reference ranges for thyroid function test parameters that represent a defined, clinically relevant change from baseline are considered marked thyroid function test abnormalities. Roche's standard reference ranges for thyroid function test parameters were used for the analysis. The thyroid function parameters with marked abnormalities were triiodothyronine (T3) (RR is 1.20 - 3.00 nanomole/liter [nmol/L]), thyroxine (T4) (RR is 51 - 154 nmol/L) and thyroid stimulating hormone (TSH) (RR is 0.0 - 5.0 milliunits per liter [mU/L]). Summary data of number of participants with only marked abnormalities in thyroid function tests are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
2849433|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II.|Up to 6 years|Full analysis set of participants with Rai Stage I or II|||months||95% Confidence Interval|Median
2849334|NCT00087607|Secondary|Number of Participants With Marked Biochemical Test Abnormalities|Values outside the marked RR for biochemical test parameters that represent a defined, clinically relevant change from baseline are considered marked biochemical test abnormalities. Roche's standard RR for biochemical parameters were used for this analysis. The biochemical test parameters with marked abnormalities were alanine aminotransferase (ALAT) (RR is 0 - 30 units per liter [U/L]), aspartate aminotransferase (ASAT) (RR is 0 - 25 U/L), gamma-glutamyl transferase (GGT) (RR is 0 - 60 U/L), total bilirubin (RR is 0 - 17 micromole/liter [umol/L]), creatinine (RR is 0 - 133 umol/L), total protein (RR is 60 - 80 g/L), triglycerides (RR is 0.45 - 1.70 millimole/liter [mmol/L]), chloride (RR is 100 - 108 mmol/L), potassium (RR is 3.5 - 5.0 mmol/L), sodium (RR is 133 - 145 mmol/L), calcium (RR is 2.10 - 2.60 mmol/L), random glucose (RR is 3.89 - 7.83 mmol/L), uric acid (140 - 500 umol/L). Summary data of number of participants with only marked biochemical test abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
2849335|NCT00087607|Secondary|Number of Participants With Marked Hematologic Abnormalities|The values outside the marked reference range for any hematology parameter that represents a defined, clinically relevant change from baseline are considered marked hematology abnormalities. The Roche standard reference ranges for the hematology parameters for which subjects had marked abnormalities were hematocrit [(RR) is 0.42 - 0.52 (fraction)], hemoglobin (RR is 13.0 - 18.0 gram/deciliter), platelets (RR is 150 - 450 10^9 cells/L), white blood cells (WBC) (RR is 4.3 - 10.8 10^9 cells/L), basophils (RR is 0.00 - 0.15 10^9 cells/L), lymphocytes (RR is 1.50 - 4.00 10^9 cells/L), monocytes (RR is 0.20 - 0.95 10^9 cells/L), neutrophils (RR is 1.83 - 7.25 10^9 cells/L), prothrombin time (PT) (RR is 9 - 13 seconds), partial thromboplastin time (Partial Throm.) (Time) (RR is 25.0 - 38.0 seconds) and PT International normalized ratio (INR) [RR is 0.70 - 1.30 (ratio)]. Summary data of number of participants with only marked hematology abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).|||participants|||Number
2849336|NCT00087607|Secondary|Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit|The viral load was determined quantitatively and qualitatively by HCV-polymerase chain reaction (PCR). Qualitative viral titers will be assessed by Roche amplicor HCV Monitor® test v2.0 (< 600 IU/mL). The virological response was determined as the percentage of participants with undetectable HCV RNA at each week. A <60 IU/mL HCV-RNA was measured by amplicor PCR assay.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).|||percentage of participants||95% Confidence Interval|Number
2849337|NCT00087607|Secondary|Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit|The virological response was determined as the proportion/percentage of participants with a ≥ 2-log10 decrease or undetectable HCV RNA at each week. Detection of >= 2-log10 decrease of <60 IU/mL HCV-RNA was done by amplicor PCR assay at each week. Detection of >=2-log10 decrease or undetectable HCV RNA at Week 12 was considered an early virological response (EVR).|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).|||percentage of participants||95% Confidence Interval|Number
2849338|NCT00087607|Secondary|Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. For the frequent-sampling cohort, HCV AUCs over 7 days were calculated for Weeks 1 and 8, with intervals calculated beginning at the dose after which the frequent sampling began (different from the 7-day calendar period used for other AUC calculations). The AUCs for Weeks 1 and 8 in the frequent-sampling cohort (Sparse samples [SS] and frequent samples [FS]) were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log (IU*week/mL)||Standard Deviation|Mean
2849339|NCT00087607|Secondary|Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period|The area under the HCV-RNA curve (HCV AUC) was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC. The HCV AUCMB to Week 12 was the sum of the 12 weekly HCV AUCMBs divided by the time (12 weeks).|Up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).|||log10 IU/mL||Standard Deviation|Mean
2849340|NCT00087607|Secondary|Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12|The HCV AUC was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC and presented.|Baseline, Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log (IU*week/mL)||Standard Deviation|Mean
2849493|NCT00085839|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 26.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.|||months||95% Confidence Interval|Median
2849341|NCT00087607|Secondary|The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The HCV AUC to Week 12 was the sum of the 12 weekly HCV AUCs divided by the time (12 weeks). Summary of weekly HCV AUC values estimated from the two adjacent pre-dose assessments are presented.|From Week -1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log 10 IU/mL||Standard Deviation|Mean
2849342|NCT00087607|Secondary|Weekly Viral Load Assessed at Drug Trough|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The viral load levels in the serum at baseline and for each week, were expressed in terms of a logarithmic scale with base 10, and averaged for all participants.|Baseline, up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.|||log (IU/mL)||Standard Deviation|Mean
2849343|NCT00087607|Secondary|Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to week 4 and week 8, expressed in terms of a logarithmic scale with base 10 are presented.|Baseline, Week 4 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).The “n” represents the number of participants analyzed at a specified time point.|||log (IU/mL)||Standard Error|Mean
2849344|NCT00087607|Primary|Change From Baseline in Viral Load (log10 Reduction) at Week 12|The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to Week 12, expressed in terms of a logarithmic scale with base 10, are presented.|From Baseline to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). Data using ITT Population are presented below.|||log (IU/mL)||Standard Error|Mean
2849345|NCT00087594|Secondary|Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2849346|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Biochemistry)|"Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2849347|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Hematology)|"Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2850226|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849348|NCT00087594|Secondary|Number of Participants With Abnormal Vital Signs|Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%.|Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2849349|NCT00087594|Secondary|Number of Participants With Compliance to the Prescribed Treatment Regimen|Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3.|Up to Week 24 for G 2/3; up to Week 48 for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2849350|NCT00087594|Secondary|Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit|The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.|Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||units on a scale||Standard Error|Mean
2849351|NCT00087594|Secondary|Number of Participants With Degrees of Depression as Defined by the BDI-II Score|Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Up to Week 72|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2849352|NCT00087594|Secondary|Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||units on a scale||Standard Error|Mean
2849353|NCT00087594|Secondary|Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||units on a scale||Standard Error|Mean
2849354|NCT00087594|Secondary|Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12||Week 12|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
2849355|NCT00087594|Secondary|Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion|Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
2849494|NCT00085839|Primary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression (maximum 5 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.|||months||95% Confidence Interval|Median
2849356|NCT00087594|Secondary|Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion|Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
2849357|NCT00087594|Secondary|Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)|SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion.|Week 48 for G2/3 and Week 72 for G1|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.|||participants|||Number
2849358|NCT00087594|Primary|Number of Participants With Treatment Completion Rate (TCR)|TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.|Up to 24 weeks for G2/3; up to 48 weeks for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.|||participants|||Number
2849359|NCT00087568|Secondary|Mean Score for Overall Local Injection Site Reaction|Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae.|Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60|Safety Population included all enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.|||Units on a scale||Standard Deviation|Mean
2849360|NCT00087568|Secondary|Number of Participants With Abnormal Vital Signs|"Abnormal vital signs were defined as~Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%~Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.~Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat"|From screening (Day -21 to Day -1) to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).|||Participants|||Number
2849361|NCT00087568|Secondary|Number of Participants With Marked Laboratory Abnormalities|Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506|Up to Week 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.|||participants|||Number
2849362|NCT00087568|Secondary|Number of Participants With Individual Flu-like Symptom|"Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The yes/no questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered yes to the question Has the patient experienced any flu-like symptoms since the last visit? all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported."|Baseline (Week 0); Weeks 12, 36, 60 and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination data, BDI-II score, or FSS score). n = number of participants available at the particular time of assessment.|||Participants|||Number
2849370|NCT00087529|Secondary|Change From Baseline to Week 96 in Brain Volume on MRI Scan|Scheduled MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total brain volume was documented at Baseline and at visits occurring during Weeks 48 and 96. Missing Week 96 values were imputed using a LOCF approach, while participants with missing Baseline values were excluded. The change in brain volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic centimeters (cm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.|||cm^3||Full Range|Median
2849363|NCT00087568|Secondary|Mean Score of Fatigue Severity Over Time|"The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with no fatigue ('0' being the best) and at the other end with greater fatigue ('100' being the worst). Longer distance on the scale from no fatigue indicated greater fatigue. FSS values are presented based on questionnaire and visual analog scale."|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, or FSS score). n = number of participants available at the particular time for assessment.|||Units on a scale||Standard Deviation|Mean
2849364|NCT00087568|Secondary|Mean Score of Beck Depression Inventory Over Time|The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all enrolled participants who received at least one dose of study drug and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score). n = number of participants available at the particular time for assessment.|||Units on a scale||Standard Deviation|Mean
2849365|NCT00087568|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).|||Participants|||Number
2849366|NCT00087568|Secondary|Number of Participants With Normal Serum Alanine Transaminase Levels Over Time|The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84|ITT Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).|||Participants|||Number
2849367|NCT00087568|Secondary|Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time|Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses.|Weeks 4, 12, 24, 36, 48, 60, and 84|Intent to treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).|||Participants|||Number
2849368|NCT00087568|Primary|Number of Pegasys and Ribavirin Therapy Completers|Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.|36 weeks for Non-Tolerators and 60 weeks for Non-Responders|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment which defined as clinical adverse event, laboratory or vital sign data, physical examination finding, Beck Depression Inventory (BDI-II), or Fatigue severity score (FSS).|||Participants|||Number
2849369|NCT00087555|Primary|The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).|"The percentage of participants who met all 3 of the following criteria:~Reduction of >=20% from baseline to week 8 in both PVAS & FIQ total score and PGI-C response of very much better or much better. Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from very much worse to very much better"|Baseline to week 8||||Percentage of Participants|||Number
2849371|NCT00087529|Secondary|Change From Baseline to Week 96 in Total Volume of Transverse Relaxation Time (T2) Brain Lesions on Magnetic Resonance Imaging (MRI) Scan|Scheduled T2-weighted MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total volume of T2 (ie, hyperintense) brain lesions at each visit was documented. Missing Week 96 values were imputed using a last observation carried forward (LOCF) approach, while participants with missing Baseline values were excluded. The change in T2 lesion volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic millimeters (mm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.|||mm^3||Full Range|Median
2849372|NCT00087529|Primary|Percentage of Participants With CDP|Disease progression was assessed using the EDSS, a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of ≥1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score >5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. The percentage of participants with CDP was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.|||percentage of participants|||Number
2849373|NCT00087529|Primary|Time to Confirmed Disease Progression (CDP)|Disease progression was assessed using the Expanded Disability Status Scale (EDSS), a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of greater than or equal to (≥) 1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score greater than (>) 5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. Those who did not meet criteria for CDP, completed treatment with only initial progression, or received an exclusionary therapy were censored at last EDSS assessment. Time to CDP was the time from randomization to initial disease progression, estimated using Kaplan-Meier (KM) analysis.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.|||weeks||95% Confidence Interval|Median
2849374|NCT00087516|Secondary|Change From Baseline in 2-hr PMG at Week 104|Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849375|NCT00087516|Secondary|Change From Baseline in FPG at Week 104|Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849376|NCT00087516|Secondary|Change From Baseline in A1C at Week 104|A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.|Weeks 0-104|The all-patients-treated population for Week 104 included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||Percent||95% Confidence Interval|Least Squares Mean
2849377|NCT00087516|Secondary|Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849378|NCT00087516|Secondary|Change From Baseline in FPG at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849379|NCT00087516|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.|||Percent||95% Confidence Interval|Least Squares Mean
2849380|NCT00087490|Secondary|Number of Participants Using Medical Resources|Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|Data was not analyzed for the primary reporting.|||Participants|||Number
2849381|NCT00087490|Secondary|Duration of Intravenous Therapy for mITT Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. N(number of participants analyzed)=participants evaluable for the measure."|||Days||Standard Error|Mean
2849382|NCT00087490|Secondary|Duration of Intravenous Therapy for PP Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.N(number of participants analyzed) = participants evaluable for the measure."|||Days||Standard Error|Mean
2849383|NCT00087490|Secondary|Duration of Hospital Stay for mITT Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.|||Days||Standard Error|Mean
2849384|NCT00087490|Secondary|Duration of Hospital Stay for PP Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.|||Days||Standard Error|Mean
2849385|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population|"Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; 0= none, 1= mild, 2= moderate and 3= severe."|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms.|||Partcipants|||Number
2849386|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population|"Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; 0= none, 1= mild, 2= moderate and 3= severe."|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms.|||Participants|||Number
2849387|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|"Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture)."|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
2849388|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|"Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT)."|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
2849389|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|"Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture)."|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
2849420|NCT00086957|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).|||Months||95% Confidence Interval|Median
2849390|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|"Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT)."|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
2849391|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|"CR evaluated at EOT visit as success (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown: excluded from present analysis."|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
2849392|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population|"CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as success (cure: resolution of clinical signs/symptoms of infection when compared to baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown was excluded from present analysis."|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."|||Percentage of participants|||Number
2849393|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|"CR evaluated at EOT visit as success (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown: excluded from present analysis."|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
2849394|NCT00087490|Primary|Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population|"Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as success (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown was excluded from present analysis."|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."|||Percentage of participants|||Number
2849395|NCT00087438|Secondary|Rate of Overall Survival at 2 Years|Overall survival time is defined as time from start of treatment to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From the start of treatment to 2 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2849396|NCT00087438|Secondary|Rate of Disease-free Survival at 2 Years|Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.|From the start of treatment to 2 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2849397|NCT00087438|Secondary|Rate of Disseminated Recurrence at 2 Years|Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method.|From the start of treatment to 2 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2849398|NCT00087438|Secondary|Rate of Regional Recurrence at 2 Years|Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method.|From the start of treatment to 2 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2850227|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849399|NCT00087438|Secondary|Rate of Local Recurrence at 2 Years|Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored).|From the start of treatment to 2 years|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2849400|NCT00087438|Secondary|Proportion of Subjects With Specified Adverse Events|"Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events:~Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration;~Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction;~Neurologic: myelitis, neuropathy (cranial and motor)~Hemorrhage: pulmonary or upper respiratory~Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion.~Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE."|From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.|All eligible patients who started study treatment|||Participants|||Count of Participants
2849401|NCT00087438|Primary|Local Control at 2 Years|Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.|From the start of treatment to 2 years|Eligible patients who started protocol treatment.|||percentage of subjects||95% Confidence Interval|Number
2849402|NCT00087152|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Every 3 weeks while on treatment for up to 3 years.|Eligible participants who received any treatment.|||Participants|||Number
2849403|NCT00087152|Secondary|Progression-free Survival at 6 Months|Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months.|Six months|Eligible participants who received treatment.|||percentage of participants||95% Confidence Interval|Number
2849404|NCT00087152|Primary|Confirmed Response Rate (Complete and Partial)|Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.|12 weeks|Eligible participants who received treatment.|||participants|||Number
2849405|NCT00087139|Secondary|Duration of Measurable Disease Response|Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease response were included in this analysis.|||Months||95% Confidence Interval|Median
2849406|NCT00087139|Secondary|Duration of PSA Response|Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response related analysis was only done among the first cohort of patients, not including the additional patients with measurable disease.|||Months||95% Confidence Interval|Median
2849432|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV.|Up to 6 years|Full analysis set of participants with Rai Stage III or IV|||months||95% Confidence Interval|Median
2849407|NCT00087139|Secondary|Proportion of Patients With Measurable Disease Response (Best Overall Response)|"Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata.~Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease were included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2849408|NCT00087139|Primary|Proportion of Patients With PSA Response|PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response rate was only calculated among the first cohort of patients, not including the additional patients with measurable disease.|||Proportion of participants||90% Confidence Interval|Number
2849409|NCT00087126|Primary|Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event).|Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||participants|||Number
2849410|NCT00087126|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients with sufficient follow-up assessments to evaluate response|||participants|||Number
2849411|NCT00087022|Post-Hoc|Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6|"This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.~The CAIX score is determined on the basis of CAIX expression via immunohistochemistry described by a combination of tumor cell extent and staining intensity.~Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy."|Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)|This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.|||Participants|||Count of Participants
2849412|NCT00087022|Secondary|Pharmacokinetics of WX-G250|Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).|Week 8|Patients who did sign amendment #3 to the study protocol and received their cG250 infusion as scheduled in the study protocol|||µg/mL||Standard Deviation|Mean
2849413|NCT00087022|Secondary|Quality of Life - Global Health Status|Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.|At 12 months|Patients still on study who completed the questionnaire|||score on a scale||Standard Deviation|Mean
2849414|NCT00087022|Primary|Overall Survival|Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.|After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)|All patients that were enrolled were included in the ITT population used for efficacy analysis|||Participants|||Count of Participants
2849415|NCT00087022|Primary|Disease-free Survival|Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.|Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)|All patients that were enrolled were included in the ITT population used for efficacy analysis|||Participants|||Count of Participants
2849416|NCT00086996|Secondary|Progression-free Survival|measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.|0-3 years|eligible patients|||months||95% Confidence Interval|Median
2849417|NCT00086996|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0-5 years|eligible patients|||months||95% Confidence Interval|Median
2849418|NCT00086996|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2849419|NCT00086996|Primary|Pathological Complete Response|Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.|10-16 weeks after beginning study treatment|Eligible patients|||participants|||Number
2849421|NCT00086957|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.|After 3 cycles of treatment, up to 2 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.|||percentage of participants|||Number
2849422|NCT00086957|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 years.|All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).|||Months||95% Confidence Interval|Median
2849423|NCT00086957|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose.|4 weeks from start of treatment, up to 2 years|All patients observed for 21 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg/m^2|||Number
2849424|NCT00086957|Primary|Number of Participants With at Least One Dose Limiting Toxicity in Phase I|Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
2849425|NCT00086684|Secondary|Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set|||participants|||Number
2849426|NCT00086684|Primary|Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set|||participants|||Number
2849427|NCT00086619|Secondary|Change in Bone Mineral Density (BMD)|Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100*[(final - month 0)/month 0] in subjects who took study therapy for at least 12 months.|baseline and 18 months (12 months in 4 subjects)|Final BMD was measured after 18 months of study therapy in 48 subjects and measured after 12 months of study therapy in 4 others who thereafter dropped out prematurely. Of the latter 4, 3 were in the ascending dose arm and 1 was in the constant dose arm.|||percent change||Standard Deviation|Mean
2849428|NCT00086619|Primary|Changes in Indices of Bone Turnover|Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months*ng/ml) for the marker.|Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.|Because this was a physiologic study evaluating the impact of stepwise increases in teriparatide, per protocol analysis was performed as was pre-specified in our analysis plan. Outcomes data were analyzed in women who remained on teriparatide throughout the first stepwise increase (i.e. until month 12 or later).|||months*(ng/ml - baseline ng/ml)||Standard Deviation|Mean
2849429|NCT00086580|Secondary|Participants With Minimal Residual Disease (MRD)|MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome.|up to 9 months|Full analysis set|||participants|||Number
2849430|NCT00086580|Secondary|Maximum Plasma Concentration (Cmax) of Fludarabine|Cmax is the maximum plasma concentration of fludarabine observed.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2849431|NCT00086580|Secondary|Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)|AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau).|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||ng*h/mL||Standard Deviation|Mean
2849434|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV.|Up to 6 years|Full analysis set of participants with Rai stage III or IV|||months||95% Confidence Interval|Median
2849435|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II.|Up to 6 years|Full analysis set of participants with Rai stage I or II|||months||95% Confidence Interval|Median
2849436|NCT00086580|Secondary|Total Volume of Distribution (Vss) of Fludarabine|The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||liters||Standard Deviation|Mean
2849437|NCT00086580|Secondary|Mean Systemic Clearance (CL) of Fludarabine|Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population|||liters/hour||Standard Deviation|Mean
2849438|NCT00086580|Secondary|Summary of Participants With Adverse Experiences (AEs)|Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab.|Up to 6 years|Safety population|||participants|||Number
2849439|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|up to month 6 (end of treatment)|Full analysis set. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
2849440|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|Day 0 (baseline)|Full analysis set. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
2849441|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|up to month 6 (end of treatment)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
2849442|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|Day 0 (baseline)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.|||units on a scale||Standard Deviation|Mean
2849443|NCT00086580|Secondary|Kaplan-Meier Estimates for Time to Alternative Therapy|Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
2849444|NCT00086580|Secondary|Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)|Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months.|Up to 6 years|Full analysis set of participants who achieved a complete response or a partial response as determined by the IRRP.|||months||95% Confidence Interval|Median
2849445|NCT00086580|Secondary|Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)|Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
2849446|NCT00086580|Secondary|Kaplan-Meier Estimates of Overall Survival Time|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
2849447|NCT00086580|Secondary|Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|Up to 9 months|Full analysis set|||participants|||Number
2849448|NCT00086580|Primary|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.|Up to 6 years|Full analysis set|||months||95% Confidence Interval|Median
2849449|NCT00086411|Secondary|Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.||52 weeks|PI is no longer with institution. All efforts have been exhausted to locate this data, but no data is available to be reported||||||
2849450|NCT00086411|Primary|Percent Treatment Sessions Attended|"Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.~A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.~Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing."|52 weeks||||Percentage of attended tx. sessions||Standard Error|Mean
2849451|NCT00086385|Primary|Participants Abstinent From Cigarettes|Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104|Two years||||participants|||Number
2849452|NCT00086515|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849453|NCT00086515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|"Change from baseline at Week 24 is defined as FPG at~Week 24 minus FPG at Week 0."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849454|NCT00086515|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|"A1C is measured as a percent. Thus, this change from~baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2849455|NCT00086502|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||mg/dL||95% Confidence Interval|Least Squares Mean
2849456|NCT00086502|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.|||Percent||95% Confidence Interval|Least Squares Mean
2849457|NCT00086450|Secondary|Rates of Individual MACCE Endpoints|Major adverse cardiovascular and cerebrovascular events|Measured at Day 30||||percentage of participants|||Number
2849458|NCT00086450|Secondary|All-cause Mortality||Measured at Year 5||||percentage of participants|||Number
2849459|NCT00086450|Secondary|Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization||Measured at Year 1||||percentage of participants|||Number
2849460|NCT00086450|Primary|5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke|median 3.8 years of follow-up|Measured at Year 5||||percentage of participants|||Number
2849461|NCT00086346|Primary|Patient and Graft Survival|Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.|12 months|Intent to treat analysis population with stratification by antimetabolite therapy and hepatitis C status.|||patients|||Number
2849462|NCT00086346|Secondary|Mean Serum Creatinine|Observed mean values for serum creatinine.|12 months|On-therapy population; consisted of patients who were still receiving study medication at the defined endpoint.|||µmol/L||Standard Deviation|Mean
2849463|NCT00086346|Secondary|Number of Patients With a Biopsy Confirmed Acute Rejection|Overall event rate is determined as yes or no.|12 months|The analysis population is the intent to treat. Any patient whose clinical rejection data was incomplete was designated as an acute rejection in the analysis.|||patients|||Number
2849464|NCT00086346|Primary|Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.|Baseline and 12 months|The intent to treat population was analyzed and consisted of all patients randomly assigned to treatment. Patients were stratified by hepatitis C status and whether or not they were receiving antimetabolite therapy at time of randomization.|||mL/min||Standard Error|Mean
2849465|NCT00086281|Primary|The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).|The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal.|One night of PSG during one night of treatment each per arm.||||Apnea + Hypopnea episodes per hour||Standard Deviation|Mean
2849466|NCT00086307|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.|Weekly|All patients with at least one post-baseline measurement were included in the analysis.|||Score on a scale||Standard Error|Least Squares Mean
2849467|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Health|Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 Mental Health score||Standard Error|Mean
2849468|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Role-Emotional|Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 Role score||Standard Error|Mean
2849469|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Vitality|Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 vitality score||Standard Error|Mean
2849470|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Component Summary|Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in SF-36 mental score||Standard Error|Mean
2849471|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being|Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in PDQ-39 Emotional score||Standard Error|Mean
2849472|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall|Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in PDQ-39 score||Standard Error|Mean
2849473|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar|Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS-Bulbar score||Standard Error|Mean
2849474|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor|Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS-tremor score||Standard Error|Mean
2849475|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor|Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS-motor score||Standard Error|Mean
2849476|NCT00086190|Secondary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in PQSI score||Standard Error|Mean
2849477|NCT00086190|Secondary|Change in Snaith Clinical Anxiety Scale (CAS)|Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in CAS score||Standard Error|Mean
2849478|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS)|Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in UPDRS score||Standard Error|Mean
2849479|NCT00086190|Secondary|Change in Brief Psychiatric Rating Scale (BPRS)|Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in BPRS score||Standard Error|Mean
2849480|NCT00086190|Secondary|Change in Geriatric Depression Rating Scale (GDS)|Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in GDS score||Standard Error|Mean
2849481|NCT00086190|Secondary|Change in Beck Depression Inventory II (BDI-II)|Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in BDI-II score||Standard Error|Mean
2849482|NCT00086190|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in MADRS score||Standard Error|Mean
2849483|NCT00086190|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.|||Change in HAM-D score||Standard Deviation|Mean
2849484|NCT00086138|Secondary|Remission According to Cornell Scale for Depression in Dementia Scale|The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.|Measured at Weeks 12||||percentage of participants|||Number
2849485|NCT00086138|Primary|Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)|"At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 (much better) to 7 (much worse), with a score of 4 being no change."|Measured at Week 12||||participants|||Number
2849486|NCT00086047|Secondary|Depressive Symptoms||9 weeks and 6 months|||||||
2849487|NCT00086047|Secondary|Pain Intensity||9 weeks and 6 months|||||||
2849488|NCT00086047|Primary|Change in FDI (Functional Disability Inventory) Scores at End of Study|Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)|Baseline and 6 months (end of study)|Intent to treat analysis|||units on a 0-60 scale||95% Confidence Interval|Mean
2849489|NCT00085917|Secondary|Number of Participants With Adverse Events|"Adverse Events~- Anemia, Neutropenia and Psychiatric adverse events"|48 weeks||||participants|||Number
2849490|NCT00085917|Secondary|Number of Participants With Normalization of Liver Enzymes|normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L|week 24, week 48, week 72||||participants|||Number
2849491|NCT00085917|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.|72 weeks||||participants|||Number
2849492|NCT00085839|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.|While receiving study treatment (maximum 60 weeks)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.|||participants|||Number
2851622|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 16||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2849495|NCT00085735|Secondary|Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)|Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 49 - 72 months post diagnosis.|49 - 72 months post diagnosis|All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.|||Percentage of Participants||95% Confidence Interval|Number
2849496|NCT00085735|Secondary|Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)|Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 27 - 48 months post diagnosis.|27-48 months post diagnosis|All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.|||Percentage of Participants||95% Confidence Interval|Number
2849497|NCT00085735|Secondary|Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)|Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission. A patient will be compliant if the patient has metacognition index score. Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows. All eligible and evaluable patients enrolled will be used. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate. The time window is 4 - 15 months post diagnosis.|4-15 months post diagnosis|All eligible and evaluable patients enrolled. Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.|||Percentage of Participants||95% Confidence Interval|Number
2849498|NCT00085735|Secondary|Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)|Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.|49 - 72 months post diagnosis|Only eligible & evaluable patients 3-7 years of age with MI values within time window were included.|||T-score||Standard Deviation|Mean
2849499|NCT00085735|Secondary|Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)|Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.|27-48 months post diagnosis|Only eligible & evaluable patients 3-7 years of age with MI values within time window were included.|||T-score||Standard Deviation|Mean
2849500|NCT00085735|Secondary|Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)|Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction.|4 - 15 months post diagnosis|Only eligible & evaluable patients 3-7 years of age with MI values within time window were included.|||T-score||Standard Deviation|Mean
2849501|NCT00085735|Secondary|Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays|PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up. Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored. PFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.|3 years|355 patients were classified into one of the medulloblastoma subgroups by methylation arrays and included in this analysis; 74 were Group 3 medulloblastoma, 154 were Group 4 medulloblastoma, 64 were SHH medulloblastoma, and 63 were WNT medulloblastoma patients.|||Percentage probability of PFS||95% Confidence Interval|Number
2849502|NCT00085735|Secondary|Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays|OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's.|3 years|355 patients were classified into one of the medulloblastoma subgroups by methylation arrays and included in this analysis; 74 were Group 3 medulloblastoma, 154 were Group 4 medulloblastoma, 64 were SHH medulloblastoma, and 63 were WNT medulloblastoma patients.|||Percent probability of overall survival||95% Confidence Interval|Number
2849557|NCT00085631|Primary|Five-year Failure-free Survival|Five-year failure free survival (FFS) time was defined as the time from randomization until relapse/disease progression (local and/or distant) or death from any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year FFS rate is a percentage representing the fraction of randomized patients who, after 5 years, are disease free or alive.|5 Years|||||||
2849503|NCT00085735|Secondary|Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group|Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests. We report the percentage of patients with abnormal growth hormone stimulation tests.|Post-treatment up to 3 years|Only eligible & evaluable patients 3-7 years of age were included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Availability of growth hormone stimulation test results were very limited. Only 3 out of 464 eligible and evaluable patients had this data available (2 PFRT patients and 1 IFRT).|||Percentage of patients||95% Confidence Interval|Number
2849504|NCT00085735|Secondary|Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4|Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.|Up to 3 years|Eligible & evaluable pts were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable(NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 eligible/evaluable pts. However some pts (28/22) weren't followed for at least 1-yr post-off tx (e.g., withdrew consent for FU or died), leaving 199 IFRT/215 PFRT pts.|||Percentage of pts with g3+ hearing loss|||Number
2849505|NCT00085735|Secondary|Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)|Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 49-72 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.|49 - 72 months post diagnosis|Eligible and evaluable patients are reported.|||Scores on a scale||Standard Deviation|Mean
2849506|NCT00085735|Secondary|Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)|Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 27-48 months post diagnosis, only the assessments before progression date were reported. The range of FSIQ is 50 - 150. A higher FSIQ is better.|27 - 48 months post diagnosis|Only eligible & evaluable patients 3-7 years of age with FSIQ observations within time window were included.|||Scores on a scale||Standard Deviation|Mean
2849507|NCT00085735|Secondary|Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).|Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 4-15 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better.|4 -15 months post diagnosis|Only eligible & evaluable patients 3-7 years of age with FSIQ observations within time window were included.|||Scores on a scale||Standard Deviation|Mean
2849508|NCT00085735|Secondary|Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4|Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients. Eligible and evaluable patients 3-7 years of age will be used.|Up to 3 years|Only eligible & evaluable pts 3-7 years of age are included since only younger pts were randomized to either LD or SD CSI. 11 and 8 LDCSI and SDCSI pts respectively were not evaluable due to anaplastic disease or excess residual/disseminated disease, leaving 116 vs 110 patients for this analysis.|||Percentage of pts with g3+ hearing loss|||Number
2849509|NCT00085735|Secondary|Post-treatment Endocrine Function by CSI Group|Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH). The mean TSH will be reported.|Up to 3 years|Only eligible & evaluable pts 3-7 years of age were included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 11 and 8 LDSCI and SDCSI pts were NE, respectively, leaving 116 vs 110 for this comparison. Of these, 89 LDSCI and 79 SDCSI pts had post-treatment TSH values available and were included.|||uU/ml||Standard Deviation|Mean
2849510|NCT00085735|Secondary|Non-posterior Fossa (NPF) Failure Rate|NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV). The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.|||Percentage of 3 yr cumulative incidence||95% Confidence Interval|Number
2849511|NCT00085735|Secondary|Non-local Posterior Fossa (NLPF) Failure Rate|NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF). The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.|||Percentage of 3 yr cumulative incidence||95% Confidence Interval|Number
2849558|NCT00085631|Primary|Primary Tumor Response Rate at 4-6 Weeks Post Treatment|Primary tumor response rate is the proportion of subjects achieving a best response of complete (CR) or partial (PR) responses, according to the RECIST criteria for change in sum of longest diameters.|3 months from start of therapy|||||||
2849559|NCT00085566|Primary|Overall Objective Response|Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)|2 years||||participants|||Number
2849512|NCT00085735|Secondary|Local Posterior Fossa (LPF) Failure Rate|LPF failure was defined as tumor recurrence/progression within the tumor bed. The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals. Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.|3 years|Eligible and evaluable patients 3-21 yrs of age are included. Patients with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). Arms I/III/V [IFRT] are combined & arms II/IV/VI [PFRT] are combined. 26 & 23 IFRT & PFRT pts were NE and were excluded, leaving 227 and 237 eligible and evaluable pts.|||percentage 3 yr cumulative incidence||95% Confidence Interval|Number
2849513|NCT00085735|Primary|Overall Survival (OS)|OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]).|3 years|Per protocol only eligible & evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.|||Probability of 3 yr OS rate||95% Confidence Interval|Number
2849514|NCT00085735|Primary|Event-free Survival (EFS)|EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).|Assessed at 3 years|Per protocol only eligible & evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.|||probability of 3 year EFS||95% Confidence Interval|Number
2849515|NCT00085709|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.|Eligible patients who started therapy|||Participants with a given type of AE|||Number
2849516|NCT00085709|Primary|Complete Remission||After induction therapy was completed (1 or 2 months)|Eligible patients who did not withdraw consent|||participants|||Number
2849517|NCT00085709|Primary|2-year Disease-free Survival (DFS)|Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.|After completing any treatment, every 6 months for 2 years, than annually for years 3-5|Eligible patients who completed induction and consolidation therapy|||Percentage of population||95% Confidence Interval|Number
2849518|NCT00085644|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question:~Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?"|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849519|NCT00085644|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849520|NCT00085644|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849578|NCT00085410|Primary|Objective Response Rate|Objective Response Rate (ORR) was determined by best response on radiologic assessment (computed tomography or magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|Up to 1 year|Per protocol|||Participants|||Count of Participants
2849621|NCT00084838|Other Pre-specified|Grade 3-4 Auditory/Hearing Events|All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849521|NCT00085644|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is -0.36. An increase in the HUI-3 score represents improvement.|Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849522|NCT00085644|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).~Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849523|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849524|NCT00085644|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).~Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849525|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849526|NCT00085644|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2849527|NCT00085644|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2849622|NCT00084838|Other Pre-specified|Grade 3/4 Events|All Grade 3-4 events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849528|NCT00085644|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849529|NCT00085644|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849530|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849531|NCT00085644|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849532|NCT00085644|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.~An increase in chest expansion represents improvement"|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2849533|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||score on a scale||Standard Deviation|Mean
2849534|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849579|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level.These Secondary Endpoints Would Only Have Been Assessed if a Patient Had Met the Primary Endpoint, Restoration of Radioiodine Uptake to Justify Radioiodine Therapy.||3 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
2849640|NCT00084409|Other Pre-specified|Define the Genes Whose Expression is Altered by Iloprost Treatment by Gene Expression Arrays and Quantitative PCR.||Nine Years|||||||
2849535|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.~ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849536|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responders - improvement of >=40% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849537|NCT00085644|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mg/dL||Standard Deviation|Mean
2849538|NCT00085644|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2849539|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849540|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849548|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849641|NCT00084409|Other Pre-specified|To Determine the Toxicity Profile of Iloprost in Patients at High Risk to Develop Lung Cancer.||Nine Years|||||||
2849541|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849542|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|"The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.~A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe]."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849543|NCT00085644|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||cm||Standard Deviation|Mean
2849544|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849545|NCT00085644|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2849546|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849547|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2849580|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level||6 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
2849549|NCT00085644|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||mm||Standard Deviation|Mean
2849550|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 70 - Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]), Total Back Pain VAS; (0 [no pain] - 100 [severe]), BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of >= 20% and a net worsening of >= 10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849551|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849552|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS (0 [none] to 10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.|||participants|||Number
2849553|NCT00085644|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.|||score on a scale||Standard Error|Mean
2849554|NCT00085644|Primary|Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none]-100 [severe]), Total Back Pain VAS (0 [no pain]-100 [severe]), BASFI VAS (0 [easy]-100[impossible]); and Inflammation VAS (0 [none]-10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Week 12||||Participants (responders, nonresponders)|||Number
2849555|NCT00085631|Primary|Five-Year Overall Survival|Five-year overall survival (OS) time was time from date of randomization until death from any cause. The 5-year OS rate is a percentage, representing the fraction of randomized patients who, after 5 years, are still alive.|5 Years|||||||
2849556|NCT00085631|Primary|Five-Year Local Recurrence-Free Survival|Five-year local recurrence-free survival (LRFS) time was defined as the time from randomization until local progressive disease or death from any cause. Local recurrence was defined as evidence of disease progression on physical exam or radiologic study, confirmed histologically by tissue biopsy. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year LRFS rate is a percentage representing the fraction of randomized patients who, after 5 years, do not have local progression or are alive.|5 years|||||||
2849592|NCT00085202|Secondary|Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa|To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.|Annually for 6 years post irradiation|||||||
2849560|NCT00085540|Secondary|Response Rate Associated With Depsipeptide Therapy (Phase II)|"RECIST Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition"|Up to 2 years|GBM patients - no responses|||participants|||Number
2849561|NCT00085540|Primary|6 Months Progression-free Survival (Phase II)|evaluated patients with glioblastoma (GBM (35 patients)|At 6 months|evaluation of patients with GBM histology|||percentage of participants|||Number
2849562|NCT00085540|Primary|Number of Participants With Dose-limiting Toxicities Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I)|"dose limiting toxicity defined as: ANC </=1000 or Platelets <100K; SGOT >/= 3X ULN and T. Bili >/= 1.5 ULN~grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI)"|First 4 weeks of treatment||||participants|||Number
2849563|NCT00085436|Secondary|Immunity as Measured by T-cell and Antibody Responses to the Tumor|All patients receiving at least one week of treatment and have at least two time points available for assessment of immune parameters will be include in the evaluation of immune status.|monthly for 5 months||||pg/mL (picogram/milliliter)||95% Confidence Interval|Number
2849564|NCT00085436|Primary|Clinical Response as Measured by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|monthly, then every 2-3 months|Clinical response as measured by RECIST monthly and then every 2-3 months|||percentage of participants|Clinical Response|95% Confidence Interval|Number
2849565|NCT00085423|Secondary|Time to Progression as Measured by RECIST|Clinical outcome used the National Cancer Institute's Response Evaluation Criteria in Solid Tumors (RECIST)1.0.|From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months||||years||95% Confidence Interval|Mean
2849566|NCT00085423|Secondary|Number of Participants With Lymphocyte Recovery as Measured by Blood Count|Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame.|on days 1-15, weekly for 2 weeks, and then every 2-3 months|each patient's differential blood counts were used to determine the time of recovery to the lower limit of normal lymphocytes in the peripheral blood.|||participants|||Number
2849567|NCT00085423|Primary|Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST|Objective response as measured by radiological and physical examination using RECIST criteria.|Response at 12 weeks|Response was determined by physical examination and radiologic testing. Percent of the total number of patients treated was calculated.|||participants|||Number
2849568|NCT00085410|Post-Hoc|6-Month and 1-Year Survival: Patients Who Did Not Derive Clinical Benefit From Study Treatment|The time from initiation of therapy to 6 months beyond. Only patients who did not derive clinical benefit from study treatment (progressive disease or unconfirmed partial response was best response) were included.|Up to 1 year|Patients who did not derive clinical benefit from study treatment (progressive disease was best response) only.|||percentage of patients|||Number
2849569|NCT00085410|Post-Hoc|6-Month and 1-Year Survival for Patients Who Derived Clinical Benefit From Study Treatment|The time from initiation of therapy to 6 months beyond. Only patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response) were included.|Up to 1 year|Patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response)|||percentage of patients|||Number
2849570|NCT00085410|Post-Hoc|1-year Survival|The time from initiation of initiation of therapy to 1 year beyond.|1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||percentage of patients|||Number
2849571|NCT00085410|Post-Hoc|6-Month Survival|The time from initiation of therapy to 6 months beyond.|6 months|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||percentage of patients|||Number
2849572|NCT00085410|Post-Hoc|Clinical Benefit Rate|Best response to study treatment was confirmed complete response, partial response, or stable disease. Unconfirmed partial response was not included. The outcome measure data table is stratified into patients who a) received prior therapy b) did not receive prior therapy.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||percentage of patients|||Number
2849573|NCT00085410|Secondary|Correlation of Treatment With Changes in Phenotypic Expression of Molecular Markers|Phenotypic expression of molecular markers before and after study treatment|Duration of study treatment|Insufficient amount of patient samples collected for analysis||||||
2849574|NCT00085410|Secondary|Correlation of Phenotypic Expression of NF-kB, p53, and Other Molecular Markers in Biliary Washings and Tumor Biopsies With Clinical Outcomes|Evaluation of clinical outcomes with expression of molecular markers specified and others. Sufficient amount of biliary washings and tumor biopsies needed for analysis.|Once in the screening period (within 14 days of starting treatment)|Insufficient amount of patient samples collected for analysis||||||
2849575|NCT00085410|Secondary|Correlation of the Degree of Proteasome Inhibition in Peripheral Blood With the Degree of Proteasome Inhibition in Tumor Specimens|Proteasome inhibition compared between tumor specimens and peripheral blood. Sufficient tissue samples are required for this analysis.|Once in the screening period (within 14 days of starting treatment)|Insufficient amount of patient samples collected for analysis||||||
2849576|NCT00085410|Secondary|Overall Survival|The time from initiation of therapy to death or last follow-up.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||months||95% Confidence Interval|Median
2849577|NCT00085410|Secondary|Time to Disease Progression|Time from initiation of therapy to first progressive disease.|Up to 1 year|1 patient who withdrew consent prior to the first disease evaluation was excluded.|||months||95% Confidence Interval|Median
2849581|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|3 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
2849582|NCT00085293|Secondary|Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional). No Secondary Endpoints Were Measured as no Patient Met the Primary Endpoint.||Baseline to 3 weeks|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
2849583|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease.|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 months|No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.||||||
2849584|NCT00085293|Secondary|Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Summary of Adverse Events (AEs) by Maximum Grade where Grade 1 AEs >20%, Grade 2 AEs >10%, all Grade 3, Grade 4 and Grade 5 reported.|Up to 6 months||||percentage of participants|||Number
2849585|NCT00085293|Primary|Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration|"Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine.~Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera."|Week 3 following 2 weeks of Decitabine therapy|Per protocol, 1 participant interpreted by local treating investigator as responsive (increased radioiodine uptake on diagnostic scan after therapy), entered second decitabine treatment receiving radioiodine therapeutic dose. Subsequent central review of both scans for formal protocol response interpreted scans as negative for radioiodine uptake.|||participants|||Number
2849586|NCT00085254|Primary|Overall Survival (Phase II)|The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels|up to 36 months||||months||95% Confidence Interval|Median
2849587|NCT00085254|Secondary|Frequency of Hematologic and Nonhematologic Adverse Events|The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0|Up to 1 year||||Number of grade 3 or 4 events|||Number
2849588|NCT00085254|Secondary|Overall Survival Based on Dose Level - Phase 2|survival calculated from date of initial histologic diagnosis and occurence of death. Pts at 500mg dose compared against Pts treated at 2000mg dose. Calculated using median|Up to 3 years|Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study|||months||95% Confidence Interval|Median
2849589|NCT00085254|Primary|Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review any dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (safety run-in)~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~cohorts at these 3 defined doses: 500mg, 1000mg and 2000mg MTD defined as: dose producing DLT in 2 out of 6 patients or dose level below the dose which produced DLT in >/= 2 out of 3 patients, or in >/= 3 out of 6 patients If no MTD (maximum tolerable dose) was defined through 3 steps of dose escalation, phase 2 will proceed with a randomized treatment allocation of the two pre-specified dosage arms: low dose; 500mg and high dose; 2000mg"|10 weeks|at least 3 pts per cohort will be used to review MTD rate for dose escalation in stepwise fashion of 3 defined doses: 500, 1000 and 2000mg. We will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.|||mg|||Number
2849590|NCT00085254|Primary|Dose Limiting Toxicities of EMD + RT and TMZ|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"|10 weeks|at least 3 pts per cohort will be used to review DLT rate for dose escalation in stepwise fashion. we will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.|||participants|||Number
2849591|NCT00085202|Secondary|Mean RT Dose to Specified Target Tissue Volume by Rate and Pattern of Failure, e.g. Local Failure, Distant Failure, Etc.|To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects.|Once all patients have been followed for 2 years|||||||
2849593|NCT00085202|Secondary|Reading Decoding Composite Scores in the Intervention and Standard of Care Groups|To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing.|Measurements will be made at time of randomization, at 3 months from initiation of treatment, and yearly thereafter for 10 years|||||||
2849594|NCT00085202|Primary|Frequency of Mutations Associated With SHH and WNT Tumors|The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.|within 3.5 years following completion of accrual|Only patients with WNT and SHH tumors with available tissue for targeted sequencing were analyzed for frequency of mutation. WNT and SHH subgroups were identified by methylation profiling.|||Participants|||Count of Participants
2849595|NCT00085202|Primary|Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.|122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.|||percentage of participants||Standard Error|Mean
2849596|NCT00085202|Primary|Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors|The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.|||probability of PFS at 2 years||Standard Error|Mean
2849597|NCT00085098|Secondary|Quality of Life (QOL) and Neurocognitive Assessment (NP)|The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. The scores range from 0 to 100 with higher score reflecting better QoL or neurocognitive assessment.|2 years from beginning of treatment|All eligible patients who also successfully completed therapy and were assessed for quality of life and neurocognitive outcome.|||Scores on a scale||Standard Deviation|Mean
2849598|NCT00085098|Secondary|Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. The list of toxicities of interest include Anemia or Febrile Neutropenia; Nausea or Vomiting; Infections and Infestations; Neutrophil or White blood count decrease; and Hypokalemia or Hyponatremia|From the beginning of treatment, assessed up to 5 years|Patients who received any pre-radiotherapy chemotherapy in Regimen B|||Participants|||Count of Participants
2849599|NCT00085098|Secondary|Number of Participants With a Response to Regimen B|To assess the complete response rate to pre-radiotherapy chemotherapy (Reg B only). Response was determined after completing 2-4 cycles of chemotherapy on Reg B. Complete Response (CR) is defined as disappearance of all target lesions.|5 years from beginning of treatment|Patients who were treated in Regimen B and had at least one response assessment are included in this analysis. One patient in Regimen B withdrew from the pre-Radiotherapy chemotherapy and did not have any response assessment were not included for the response analysis.|||Participants|||Count of Participants
2849600|NCT00085098|Primary|Event-free Survival|"Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.~QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.~Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol's primary objective.~NOTE: Reported data are through May 2009 (see Caveats section)."|Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years|By protocol design, all eligible patients were considered in the evaluation of primary study aim. Two (2) patients were considered ineligible. All other patients (10 enrolled to regimen A and 12 enrolled to regimen B) are included in the evaluation for the primary outcome measure.|||participants|||Number
2849601|NCT00084864|Secondary|Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0|Number of Participants with Adverse Events, Graded According to NCI CTCAE v2.0|Up to 30 days of the last administration of study procedure|All treated and eligible patients|||Participants|||Count of Participants
2849602|NCT00084864|Secondary|Determine the Acute Effects of This Regimen on Serum PSA in These Patients.||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
2850228|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849603|NCT00084864|Secondary|Determine the Effect of This Regimen on the Expression of Apoptosis Markers|Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.|Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
2849604|NCT00084864|Secondary|Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
2849605|NCT00084864|Primary|Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy||Up to 30 days of the last administration of study procedure|Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.||||||
2849606|NCT00084838|Other Pre-specified|Grade 3-4 Allergy/Immunology|All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849607|NCT00084838|Other Pre-specified|Grade 3-4 Hemorrhage Events|All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849608|NCT00084838|Other Pre-specified|Grade 3-4 Dermatology Events|All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849609|NCT00084838|Other Pre-specified|Grade 3-4 Renal/Genitourinary Events|All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849610|NCT00084838|Other Pre-specified|Grade 3-4 Pulmonary Events|All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849611|NCT00084838|Other Pre-specified|Grade 3-4 Cardiovascular Events|All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849612|NCT00084838|Other Pre-specified|Grade 3-4 Hepatic Events|All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849613|NCT00084838|Other Pre-specified|Grade 3-4 Muscloskeletal Events|All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849614|NCT00084838|Other Pre-specified|Grade 3-4 Constitutional Events|All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849615|NCT00084838|Other Pre-specified|Grade 3-4 Pain Events|All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849616|NCT00084838|Other Pre-specified|Grade 3-4 Neurology Events|All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849617|NCT00084838|Other Pre-specified|Grade 3-4 Infection/Febrile Neutropenia Events|All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849618|NCT00084838|Other Pre-specified|Grade 3-4 Metabolic/Laboratory Events|All Grade 3-4 Metabolic/Laboratory events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849619|NCT00084838|Other Pre-specified|Grade 3-4 Gastrointestinal Events|All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.|||adverse events|||Number
2849623|NCT00084838|Secondary|Pre-Radiation Therapy Chemotherapeutic Response|"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.~Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples."|Assessed at study entry and pre-RT/post-CT at week 7.|The pre-RT CT response evaluable population is defined as patients who completed chemotherapy per protocol.|||proportion of evaluable patients||90% Confidence Interval|Number
2849624|NCT00084838|Primary|2-yr Overall Survival|Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up.|Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.|The analysis dataset is comprised of all eligible and treated patients.|||probability|||Number
2849625|NCT00084747|Secondary|Overall Survival||up to 5 years from time of consent||||months||Full Range|Median
2849626|NCT00084747|Primary|Progression-free Survival|Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.|signed consent to progression or end of trial. Up to 5 years.||||months||Full Range|Median
2849627|NCT00084682|Secondary|Overall Survival|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.|Up to 2 years|||||||
2849628|NCT00084682|Secondary|Time to Progression|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.|Up to 2 years|||||||
2849629|NCT00084682|Secondary|Duration of Response||Up to 2 years|||||||
2849630|NCT00084682|Primary|Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 2 years||||participation||95% Confidence Interval|Number
2849631|NCT00084617|Secondary|Overall Survival|Length of time patients survived after treatment|at 40 months from study activation|All patients enrolled in study|||months||95% Confidence Interval|Median
2849632|NCT00084617|Secondary|Complete Response (CR) and Partial Response (PR) Duration|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|at 40 months from study activation|Patients that achieved either a CR or PR.|||months||95% Confidence Interval|Median
2849633|NCT00084617|Primary|Response Rates (RR) in Metastatic Gastric/GE Junction Tumors|Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.|at 12 weeks (after 2 cycles of treatment)|Patients that completed at least 2 cycles of treatment|||participants|||Number
2849634|NCT00084487|Secondary|Overall Survival|Percentage of patients alive at 1 year|1 year|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2849635|NCT00084487|Secondary|Progression Free Survival|Percentage of patients that are progression free at 6 months.|6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2849636|NCT00084487|Primary|Overall Survival|Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
2849637|NCT00084487|Primary|Progression Free Survival|Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat|||months||95% Confidence Interval|Median
2849638|NCT00084487|Primary|Objective Response Rate Estimated as the Proportion of Responders|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.~An exact binomial 95% confidence interval will be calculated for this proportion."|Up to 4 years|Intent to treat|||participants|||Number
2849639|NCT00084409|Other Pre-specified|To Determine Whether Iloprost Can Modulate a Panel of Biomarkes.|To determine if Iloprost can modulate a panel of biomarkers including MCM-2, EGFR, Her-2/neu, RARβ, p53, FHIT, apoptotic index, and microvessel density.|9 years|||||||
2849642|NCT00084409|Other Pre-specified|To Determine Whether Iloprost Affects Prostaglandin Metabolism by Examining 4 Markers, PGIS, COX-2, PPAR and PPAR.|PGIS (Prostacyclin synthase: an enzyme in the eicosanoid pathway that catalyzes the conversion of prostaglandin H2 to prostaglandin I2 (prostacyclin). PPAR (Peroxisome proliferator-activated receptor: a group of nuclear receptor proteins that act as transcription factors regulating gene expression),|Nine years|||||||
2849643|NCT00084409|Other Pre-specified|To Determine if Iloprost Can Modulate K-67 Proliferation Index in Patients at High Risk to Develop Lung Cancer||nine years|||||||
2849644|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.|||Percentage points||Standard Deviation|Mean
2849645|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.|||WHO Units||Standard Deviation|Mean
2849646|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.|||WHO Units||Standard Deviation|Mean
2849647|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years||||Percentage points||Standard Deviation|Mean
2849648|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
2849649|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies.~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
2849650|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years||||Percentage points||Standard Deviation|Mean
2849651|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
2849652|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL (Right upper lobe: the superior region of the right lung), RML (Right middle lobe: an anatomic portion of the right lung), RB6 (The carina in the right lower lobe at the entrance to the superior segment), LUL (Left upper lobe: the superior portion of the lung), LUDB (Left upper division bronchus: the carina between the lingular orifice and the left upper lobe), and LB6 (The carina in the left lower lobe at the entrance to the superior segment).~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years||||WHO Units||Standard Deviation|Mean
2849653|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From all biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years||||Percentage points||Standard Deviation|Mean
2849654|NCT00084409|Primary|Change in Average (Follow-up - Baseline) From All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes.~WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|Nine years||||WHO Units||Standard Deviation|Mean
2849655|NCT00084383|Primary|Disease-free Survival|Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.|Participants were followed for the duration of the study, an average of 2 years||||Months||95% Confidence Interval|Median
2849656|NCT00084383|Secondary|Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines.|The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.|Continuous|||||||
2849657|NCT00084383|Secondary|To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.||4 years|||||||
2849658|NCT00084383|Primary|Overall Survival|Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.|Participants were followed for the duration of the study, an average of 2 years||||Months||95% Confidence Interval|Median
2849659|NCT00084318|Secondary|Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival||From randomization to two years|Effective and reliable assessment of nuclear expression of these receptors was not achieved and therefore no data was available for analysis.||||||
2849660|NCT00084318|Secondary|Local-regional Control|Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2849661|NCT00084318|Secondary|Frequency of Other Acute and Late Toxicity|Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.|From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants|||Number
2849662|NCT00084318|Secondary|Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)|Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was >30%. [RTOG = Radiation Therapy Oncology Group]|From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2849663|NCT00084318|Secondary|Treatment Tolerance|Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.|From start of treatment to end of treatment (protocol treatment lasts seven weeks).|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2849664|NCT00084318|Secondary|Overall Survival|Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2849707|NCT00084084|Other Pre-specified|Heart Rate Variability - Change From Baseline at Week 185 in SDNN|Heart rate variability was assessed by 2-hour Holter monitoring. Standard deviation of all filtered RR intervals over the length of the analysis (SDNN) was measured.|Week 185|Number of participants present at Visit Week 185 included for analysis.|||msec||Standard Deviation|Mean
2849665|NCT00084318|Primary|Disease-free Survival|Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2849666|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for ITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|ITT population included all participants who received at least one dose of study medication.|||Days||Standard Error|Mean
2849667|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for mITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.|||Days||Standard Error|Median
2849668|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for PP Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Days||Standard Error|Mean
2849669|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population|Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
2849670|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for PP Population|Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
2849671|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population|Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
2849672|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for PP Population|Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
2849673|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
2849674|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
2849675|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
2849676|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
2849677|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
2849678|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
2849679|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.|||Participants|||Number
2849708|NCT00084084|Secondary|Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞)|AUC0-∞ is a measure of the total exposure to a drug.|341 weeks|PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.|||min·U/mL||Standard Deviation|Mean
2849680|NCT00084266|Primary|Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.|||Participants|||Number
2849681|NCT00084149|Secondary|CD4 T Cell Levels||At Week 48||||cells/mm^3||Inter-Quartile Range|Median
2849682|NCT00084149|Secondary|Number of Patients With Viral Load Less Than 50 Copies/ml||Week 48||||Participants|||Count of Participants
2849683|NCT00084149|Secondary|HIV-1 Viral Load Levels||At Week 48||||log10(copies/mL)||95% Confidence Interval|Mean
2849684|NCT00084149|Secondary|Proviral DNA (log10)||At Week 12||||log10(copies/mL)||Inter-Quartile Range|Median
2849685|NCT00084149|Secondary|Proviral DNA Levels (log10)||At Week 24||||log10(copies/mL)||Inter-Quartile Range|Median
2849686|NCT00084149|Secondary|Adverse Events Related to Study Medication|Grade 1-4 adverse events related to study medication|Up to 48 weeks||||participants|||Number
2849687|NCT00084149|Primary|Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)||At 48 weeks after the start of treatment|All participants completing week 48 visit.|||log10(copies/mL)||Inter-Quartile Range|Median
2849688|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until study closure (May 31, 2010)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.|||weeks||95% Confidence Interval|Number
2849689|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 using follow-up through study closure on May 31,2010||||weeks||95% Confidence Interval|Number
2849690|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 using follow-up through study closure on May 31,2010||||weeks||95% Confidence Interval|Number
2849691|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 (using follow-up through to study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.|||weeks||95% Confidence Interval|Number
2849692|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up through study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.|||weeks||95% Confidence Interval|Number
2849693|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.|||participants|||Number
2849694|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)|ITT - ignoring both current treatment status and treatment history.|||cells/mm^3||Inter-Quartile Range|Median
2849695|NCT00084136|Secondary|Time to Immunologic Failure (NRTI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including all follow-up through study closure - May 31,2010)||||weeks||95% Confidence Interval|Number
2849696|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until study closed (May 31,2010)|Participants not starting study treatment excluded.|||weeks||95% Confidence Interval|Number
2849697|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)||||weeks||95% Confidence Interval|Number
2849698|NCT00084136|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.|||weeks||95% Confidence Interval|Number
2849699|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.|||participants|||Number
2849700|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.|||weeks||95% Confidence Interval|Number
2849701|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT - ignoring both current treatment status and treatment history.|||cells/mm^3||Inter-Quartile Range|Median
2849702|NCT00084136|Secondary|Time to Immunologic Failure (PI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)|ITT (ignoring current study treatment status or history)|||weeks||95% Confidence Interval|Number
2849703|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)|Participants not starting study treatment excluded.|||weeks||95% Confidence Interval|Number
2849704|NCT00084136|Primary|Time to Treatment Failure (NRTI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.|||weeks||95% Confidence Interval|Number
2849705|NCT00084136|Primary|Time to Treatment Failure (PI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.|||weeks||95% Confidence Interval|Number
2849706|NCT00084084|Secondary|Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)|Cmax is the peak plasma concentration of a drug after administration.|341 weeks||||U/mL||Standard Deviation|Mean
2849710|NCT00083915|Primary|Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.|Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)|3 years depending on start date|only 2 participants in high dose (HD) melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.||||||
2849711|NCT00083889|Secondary|Ctrough Concentrations of SU011248 and Active Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples at observation.|||ng/mL||Standard Deviation|Mean
2849712|NCT00083889|Secondary|Ctrough Concentrations of Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples|||ng/mL||Standard Deviation|Mean
2849713|NCT00083889|Secondary|Ctrough Concentrations of SU011248|Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples.|||ng/mL||Standard Deviation|Mean
2849714|NCT00083889|Secondary|Incremental Cost Effectiveness Ratio (ICER)|Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.|post study measurement||||ratio|||Number
2849715|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one PK (pharmacokinetic) sample; n = subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. Abbreviations: C = Cycle, D = Day, bFGF: basic fibroblast growth factor.|||pg/ml and ratio to Baseline||Standard Deviation|Mean
2849716|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|"Pharmacodynamic analyses performed at selected sites on AT population who had at least one pharmacokinetic sample; n= SU011248, INF-α; Abbreviations: C: Cycle, D: Day, VEGF: vascular endothelial growth factor, sVEGFR-3: soluble vascular endothelial growth factor Receptor-3, IL-8: interleukin-8, bFGF: basic fibroblast growth factor.~."|||pg/ml and ratio to Baseline||Standard Deviation|Mean
2849717|NCT00083889|Secondary|Euro-QoL Visual Analog Scale (EQ-VAS)|EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849718|NCT00083889|Secondary|EuroQoL Five Dimension (EQ-5D) Health State Index|EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849719|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale|Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT|||scores on scale||Standard Deviation|Mean
2849720|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale|Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849721|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale|Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849722|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale|Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849723|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G)|Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849724|NCT00083889|Primary|Progression-Free Survival (PFS), Investigator's Assessment|Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
2849725|NCT00083889|Secondary|FACT-Kidney Symptom Index (FKSI) Subscale|FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.|||scores on scale||Standard Deviation|Mean
2849726|NCT00083889|Secondary|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively.|||scores on scale||Standard Deviation|Mean
2849727|NCT00083889|Secondary|Duration of Response (DR), Investigator's Assessment|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
2849728|NCT00083889|Secondary|Duration of Response (DR), Core Radiology Assessement|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duraton of treatment phase|ITT|||weeks||95% Confidence Interval|Median
2849804|NCT00082381|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%).|26 weeks|Last Observation Carried Forward; Intent to Treat|||percentage of participants|||Number
2849729|NCT00083889|Secondary|Time to Tumor Progression (TTP), Investigator's Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
2849730|NCT00083889|Secondary|Time to Tumor Progression (TTP), Core Radiology Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT|||weeks||95% Confidence Interval|Median
2849731|NCT00083889|Secondary|Overall Survival (OS)|Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.|Clinic visit or telephone contact every 2 months until death|ITT|||weeks||95% Confidence Interval|Median
2849732|NCT00083889|Secondary|Objective Response, Investigator's Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT|||participants|||Number
2849733|NCT00083889|Secondary|Objective Response, Core Radiology Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT|||participants|||Number
2849734|NCT00083889|Primary|Progression-Free Survival (PFS), Core Radiology Assessment|Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||weeks||95% Confidence Interval|Median
2849735|NCT00004146|Primary|Correlation Between PK CAI and Toxicity in This pt Population|PK paramenters including steady state CAI concentrations with toxicity/or drug activity|during treatment|50 subjects had PK samples for analysis|||ug/ml||Standard Deviation|Mean
2849736|NCT00004146|Primary|Toxicity of CAI When Combined With RT|patients who experienced a grade 3 or higher event considered at least possibly related to CAI|pts were reviewed for toxicity while on treatement - median time of 2 months|pts were treated for a median time of 2 months (23 days to 46 months). patients who experienced a grade 3 or higher event considered at least possibly related to CAI|||participants|||Number
2849737|NCT00004146|Primary|Overall Survival Rate|estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death|approximately 30 months|intent to treat pt population. time from histological diagnosis to death.|||months||95% Confidence Interval|Median
2849738|NCT00083759|Secondary|American College of Rheumatology (ACR)70|≥70% reduction from baseline in painful/tender joint count and swollen joint count and ≥70% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6||||participants|||Number
2849739|NCT00083759|Secondary|American College of Rheumatology (ACR)50|≥50% reduction from baseline in painful/tender joint count and swollen joint count and ≥50% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6||||participants|||Number
2849740|NCT00083759|Primary|American College of Rheumatology (ACR)20.|≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6||||participants|||Number
2849741|NCT00083720|Primary|Number of Participants With Serious Adverse Events|Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, was life threatening, required inpatient hospitalization or caused prolongation of existing hospitalization,congenital anomaly/birth defect, or any important medical event.|A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.|||Participants|||Number
2849742|NCT00083720|Primary|Number of Participants With Adverse Events|Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.|||Participants|||Number
2849743|NCT00083720|Secondary|Overall Survival|This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months.|Overall survival was calculated from the time of the first day of therapy to the date of death for the mITT population.|||Months||95% Confidence Interval|Median
2849744|NCT00083720|Secondary|Time to Progression|This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment.|Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months).|This measure was calculated for the mITT population.|||Months||95% Confidence Interval|Median
2849745|NCT00083720|Secondary|Duration of Response|In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of response of living patients with no evidence of PD was censored on the date of their last tumor assessment.|The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months).|The duration of response was calculated for the subgroup of the mITT population who demonstrated a response.|||Months||95% Confidence Interval|Median
2849746|NCT00083720|Secondary|Percentage of Participants With Disease Control (CR, PR, or SD)|This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated.|Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.|Disease control rate was the total number of patients with best overall response of CR, PR and SD divided by the total number of patients treated.|||Percentage of participants||95% Confidence Interval|Mean
2849747|NCT00083720|Primary|Percentage of Participants With an Overall Resonse|Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.|Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The overall response rate was calculated for the modified Intent to Treat (mITT) population.|||percentage of participants||95% Confidence Interval|Mean
2849748|NCT00083616|Secondary|Overall Survival|Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||months||95% Confidence Interval|Median
2849749|NCT00083616|Secondary|Duration of Stable Disease|Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease|||Weeks||95% Confidence Interval|Median
2849750|NCT00083616|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Weeks||95% Confidence Interval|Median
2849751|NCT00083616|Secondary|Time to Disease Progression|Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Weeks||95% Confidence Interval|Median
2849752|NCT00083616|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Weeks||95% Confidence Interval|Median
2849753|NCT00083616|Secondary|Time to Response|Median time from enrollment to objective tumor response for participants who responded.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response|||Weeks||Inter-Quartile Range|Median
2849754|NCT00083616|Secondary|Number of Participants With Objective Tumor Response Throughout Study|"Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no unequivocal progression of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease."|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Participants|||Number
2849755|NCT00083616|Primary|Duration of Response|"The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no unequivocal progression of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease."|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response|||Weeks||95% Confidence Interval|Median
2849756|NCT00083616|Primary|Number of Participants With Objective Tumor Response Through Week 16|"Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no unequivocal progression of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease."|16 weeks|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)|||Participants|||Number
2849757|NCT00083551|Primary|Overall Survival|Overall Survival at six years after initiating protocol therapy|6 Years||||percentage of participants|||Number
2849758|NCT00083382|Primary|Best Response|"Best response to study treatment as defined by protocol-specific response criteria:~Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma.~Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease."|2 years||||participants|||Number
2849759|NCT00082888|Secondary|Number of Patients Who Experienced Grade 3 or 4 Toxicities|"Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0.~Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL(Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.).~Grade 4: Life-threatening consequences; urgent intervention indicated."|Up to 56 days|Only eligible participants are included in this analysis.|||Participants|||Count of Participants
2849760|NCT00082888|Secondary|Duration of Response|Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression (PD) is documented. CR:Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy PR:≥50% decrease in SPD of the six largest dominant nodes or nodal masses. PD:≥50 % increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders or appearance of any new lesion during or at the end of therapy.|up to 2 years|Patients who had a response were included in this analysis.|||months||95% Confidence Interval|Median
2849761|NCT00082888|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation. Progression is defined as ≥50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or nonresponders or appearance of any new lesion during or at the end of therapy.|up to 2 years||||months||95% Confidence Interval|Median
2849762|NCT00082888|Secondary|Overall Survival|Overall survival time was defined as the time from registration to the date of death or last follow-up.|Up to 2 years|All participants are included in this analysis.|||months||95% Confidence Interval|Median
2849763|NCT00082888|Primary|Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|During the first 6 cycles of treatment|All participants are included in this analysis.|||Proportion of participants|||Number
2849764|NCT00082810|Secondary|Median Overall Survival|The 95% confidence intervals will be used.|From randomization until death or censored at the date of last follow-up, assessed up to 4 years||||months||95% Confidence Interval|Median
2849765|NCT00082810|Secondary|Toxicity as Assessed by NCI CTCAE Version 3.0|Number of Participants with serious (grade 3) or life-threatening (grade 4) adverse events|Up to 4 years|All treated patients who received at least one dose of tipifarnib were included in the safety analysis. A total of 342 cycles of therapy were administered (median 7 cycles/patient range 1-36 cycles)|||Participants|||Count of Participants
2849766|NCT00082810|Secondary|Duration of Response|DOR was defined for responders as the time from the onset of first response to disease progression and for non-responders as zero|Up to 4 years||||months||95% Confidence Interval|Median
2849767|NCT00082810|Secondary|Time to Progression (TTP)|TTP was estimated using the Kaplan-Meier method.|From randomization until progression of the disease, assessed up to 4 years||||months||95% Confidence Interval|Median
2849768|NCT00082810|Primary|Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)|Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 24 weeks||||participants|||Number
2849769|NCT00082758|Primary|Number of Responders (Response Rate)|Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.|Up to 30 weeks|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.|||participants|||Number
2849770|NCT00082641|Primary|Peak Immune Response as Measured by Number of Spots Per Cells|This outcome measure examined the importance of vaccine timing on antigen-specific relative to the primary cytotoxic therapy on the augmentation of antigen specific immune responses by measuring the duration of immune responses of participants|6 months after last immunization|Due to the low numbers of participants analyze in each arm, 7 participants analyze in the Early vaccine administration 4 participants analyzed in the late vaccine administration the subjects were analyzed together for this outcome.|||spots per 300,000 cells||Full Range|Median
2849771|NCT00082641|Primary|Percent of Patients With an Immune Response to p53-infected Autologous Dendritic Cells||Through study completion, an average of 18 months||||percentage of patients|||Number
2849772|NCT00082641|Primary|Number of Participants Who Experienced Toxicity to the Vaccine|This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.|1 week after each vaccine dose.||||Participants|||Count of Participants
2849773|NCT00083226|Secondary|Progression Free Survival|Time from registration to disease progression or death, whichever occurred earlier. Patients alive and progression-free were censored at last follow up. 36 eligible and treated patients were included in the analysis. The other 2 eligible and treated patients had no disease status information.|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year.|eligible and treated patients with progression status information|||months||95% Confidence Interval|Median
2849774|NCT00083226|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients alive were censored at follow up. Analysis was conducted in the 38 eligible and treated patients.|assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated|||months||95% Confidence Interval|Median
2849775|NCT00083226|Primary|Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)|Tumor response was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Objective response rate included complete response (disappearance of all tumor lesions) and partial response (At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.).|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2849776|NCT00083174|Secondary|Incidences of Other Malignancies|Other malignancies includes any other malignancy which is not in breast.|Over randomization period of study (median follow-up 35 months)|Women who have received treatment|||participants|||Number
2849805|NCT00082381|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post baseline data|||percentage||Standard Error|Least Squares Mean
2849777|NCT00083174|Secondary|Incidence of Clinically Relevant Cardiac Events|Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths|During protocol treatment in randomization period (up to 5 years)|Women who received treatment during randomization period|||participants|||Number
2849778|NCT00083174|Secondary|Incidence of All Clinical Fractures||During protocol treatment over randomization period of study (up to 5 years)|Women who have received treatment|||participants|||Number
2849779|NCT00083174|Secondary|Number of Clinical Breast Biopsies||Over randomization period of study (median follow-up 35 months)|Women who had at least one clinical breast biopsy|||number of clinical breast biopsies||Full Range|Median
2849780|NCT00083174|Secondary|Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events||Over randomization period of study (median follow-up 35 months)|Intent-to-treat (ITT)|||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
2849781|NCT00083174|Secondary|Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer|It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive.|Over randomization period of study (median follow-up 35 months)|Intent-to-treat (ITT)|||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
2849782|NCT00083174|Primary|Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)|Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.|Over randomization period of study (median follow-up 35 months)|intention to treat (ITT)|||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
2849783|NCT00083174|Primary|Percentage of Women With Serious Adverse Events|Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.|5 years open-label extension period|Postmenopausal women who were randomized to exemestane in original MAP.3 study and chose to continue to receive exemestane for up to 5 years and those randomized to placebo and decided to start 5 years of exemestane.|||percentage of women||95% Confidence Interval|Number
2849784|NCT00083122|Secondary|Time to Progression|Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Time from registration to the date of progression or last follow-up, assessed up to 3 years|All 40 participants from Group 1 were analyzed. However, due to slow accrual and early closure, Group 2 was not statistically analyzed for this endpoint.|||months||95% Confidence Interval|Median
2849785|NCT00083122|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier.|Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years|All 40 participants in Group 1 were analyzed for this primary endpoint. However, due to the low accrual and early group 2 closure, Group 2 was not statistically evaluated for this endpoint.|||months||95% Confidence Interval|Median
2849786|NCT00083122|Primary|Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)|"A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers.~A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.~A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart."|24 weeks|All 45 participants were analyzed.|||Percentage of Participants|||Number
2849787|NCT00082628|Secondary|Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I|Failure rate based on VAT was assessed by CT scan at L4-L5. The failure rate was defined as the percentage of subjects who regained >50% of their VAT lost in Treatment Period I. This outcome was to be assessed for subjects who received Serostim® 4 mg in Period I.|Week 36|"The modified ITT Population for treatment period II was defined as subjects who were re-randomized into Weeks 12 to 36 of the study and who had at least one post-Week 12 efficacy evaluation. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||percentage of subjects|||Number
2849788|NCT00082628|Secondary|Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12|Lipid profile data was analyzed for Non-HDL Cholesterol.|Baseline, Week 12|"The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2849789|NCT00082628|Secondary|Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12|Body image distress was assessed on a scale ranging from 0 to 100, where 0 = Extremely Upsetting and 100 = Extremely Encouraging.|Baseline, Week 12|The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I.|||units on a scale||Standard Deviation|Mean
2849790|NCT00082628|Secondary|Treatment Period I: Change From Baseline in Trunk Fat at Week 12|Changes in trunk fat was measured as changes in mass (kg) on Dual-Energy X-Ray Absorptiometry (DXA) Scan.|Baseline, Week 12|"The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||Kilogram (Kg)||Standard Deviation|Mean
2851623|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 8||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2849791|NCT00082628|Primary|Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12|Absolute area of VAT was measured by cross-sectional computed tomography (CT) scan at the level of the L4-5 inter-vertebral disk. CT scanning was to be used to assess the cross sectional area of abdominal fat and its distribution between the visceral and subcutaneous compartments, as measured at L4-L5.|Baseline, Week 12|"The modified ITT Population was defined as all subjects who had a baseline and at least one post-baseline efficacy measurement in treatment period I. Here Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome."|||Square Centimeter (cm^2)||Standard Deviation|Mean
2849792|NCT00082433|Primary|Overall Survival (OS)|Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.|from date of randomization until death|Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.|||months||95% Confidence Interval|Median
2849793|NCT00082433|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment|Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)|||units on a scale||95% Confidence Interval|Mean
2849794|NCT00082433|Secondary|Treatment-Related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.|||Participants|||Number
2849795|NCT00082433|Secondary|Time to Response|"Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for partial or complete (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure)."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)|||weeks||Full Range|Median
2849796|NCT00082433|Secondary|Duration of Response|"Measured from the time RECIST criteria (described in previous outcome measure) were first met for complete or partial response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)|||Months||95% Confidence Interval|Median
2849797|NCT00082433|Secondary|Response Rate (RR)|"RR=number of patients in that group whose best response is partial(30% decrease in the sum of the longest diameter of target lesions) or complete (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants"|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).|||percentage of participants||95% Confidence Interval|Mean
2849798|NCT00082433|Secondary|Progression-Free Survival (PFS)|PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.|||months||95% Confidence Interval|Median
2849799|NCT00082381|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26|Baseline, week 26|Intent to Treat|||events per 30 days per patient||Standard Error|Least Squares Mean
2849800|NCT00082381|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study|26 weeks|Intent to Treat|||percentage of participants|||Number
2849801|NCT00082381|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat|||mmol/L||Standard Error|Least Squares Mean
2849802|NCT00082381|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat|||mmol/L||Standard Error|Least Squares Mean
2849803|NCT00082381|Secondary|Change in Body Weight|Change in body weight from baseline to week 26|Baseline, week 26|Intent to Treat|||kg||Standard Error|Least Squares Mean
2849807|NCT00082407|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study|52 weeks|Intent to Treat|||percentage of participants|||Number
2849808|NCT00082407|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat|||mmol/L||Standard Deviation|Mean
2849809|NCT00082407|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 52|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.|||mmol/L||Standard Error|Least Squares Mean
2849810|NCT00082407|Secondary|Change in Body Weight|Change in body weight from baseline to week 52.|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.|||kg||Standard Error|Least Squares Mean
2849811|NCT00082407|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 52 (percentage = [number of subjects with HbA1c <=7% at week 52 divided by number of subjects with HbA1c >7% at baseline] * 100%).|52 weeks|Last Observation Carried Forward; Intent to Treat|||percentage of participants|||Number
2849812|NCT00082407|Primary|Change in Glcosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post-baseline data.|||percentage||Standard Error|Least Squares Mean
2849813|NCT00082368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|69 months||||participants|||Number
2849814|NCT00082368|Primary|Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.|Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.|3 days||||% change in Tc-94m Sestamibi SUVmax||Full Range|Mean
2849815|NCT00082355|Secondary|Number of Participants That Developed Hemorrhage|The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT.|5 days|The number of participants analyzed is an Intent-to-Treat (ITT) population. The accrual target was to analyze outcomes(immediate, at 6 weeks, and at 6months) after treatment of DVT with alteplase in 25 patients. 30 patients were treated but two participants did not complete the study for 6 week and 6 month outcome assessments.|||participants|||Number
2849816|NCT00082355|Primary|Number of Participants With Restored Venous Function|The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams.|6 months|The number of participants analyzed is an Intent-to-Treat (ITT) population. The initial goal was to be able to evaluate outcomes of treatment of DVT with alteplase over a 6 month period in 25 patients. 30 patients were treated but two participants did not complete the study before being assessed for this outcome measure.|||participants|||Number
2849817|NCT00082342|Secondary|Bradykinesia Measure Before and After Real and Sham tDCS.|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post, 1 month post, 3 months post tDCS||||seconds||Standard Deviation|Mean
2849818|NCT00082342|Secondary|UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham. Subjects were assessed on medication and off medication.|baseline, 1 day post, 1 month post, and 3 months post real and sham tDCS||||units on a scale||Standard Deviation|Mean
2849819|NCT00082342|Secondary|UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall clinical rating scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score was obtained from subject examination, subject interviews and questionnaires. The UPDRS encompasses measurement of mentation, behavior, mood, activities of daily living and motor skills. The total UPDRS scores ranges from 0 (not affected) to 176 (most severely affected). The UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham, while on medication and off medication.|baseline, 1 day post, 1 month post, 3 months post-tDCS||||units on a scale||Standard Deviation|Mean
2849820|NCT00082342|Primary|Gait Speed Before and After Real and Sham tDCS.|Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.|baseline, 1 day post, 1 month post, 3 months post-tDCS|Intent to treat|||Seconds||Standard Deviation|Mean
2849821|NCT00082329|Secondary|To Examine 1) the Cellular Content and Other Immune Properties of Mobilized Cells; 2) Yields of Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis; and 3) Safety Profile of AMD3100.||Through day 7|||||||
2850229|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849822|NCT00082329|Primary|To Determine the Cytokine Polarization Status of Cluster of Differentiation 4 (CD4)+ T-cells Collected by Apheresis Following Combination of AMD3100 and G-CSF Compared to G-CSF Mobilization.|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization. The successful treatment responders will complete study treatment with cell mobilization and cell collection. Non-responders will have completed the study treatment and have cell mobilization without cell collection."|Day 1 (cells are counted 24 hours after AMD3100)||||participants|||Number
2849823|NCT00082173|Secondary|Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications|Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications|8 weeks|DAIDS Table of Adverse Events|||Participants|||Number
2849824|NCT00082173|Primary|Proportion of Patients With Sterile Sputum Cultures|Proportion of patients with sterile sputum cultures|8 weeks|Proportion of patients with sterile sputum cultures at week 8|||Participants|||Number
2849825|NCT00003726|Primary|Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer|Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.|18 months|No data were collected||||||
2849826|NCT00081939|Primary|Percentage of Participants With Progression-Free Survival (PFS) at 3 Years From Initiation of Study Treatment|In patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a >25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.|3 years||||percentage of participants|||Number
2849827|NCT00082017|Other Pre-specified|Effect of UCN-01 on Anaplastic Lymphoma Kinase (ALK) Expression in ALCL|Gene expression patterns in participants ALK positive tumors will be assessed.|Day 3-5 after drug administration|This outcome measure was not done because data were insufficient to assess for possible effects of UCN-01 on ALK expression.||||||
2849828|NCT00082017|Other Pre-specified|Evaluation of Mature T-cell Lymphoma Cells by Complementary Double-Stranded Deoxyribonucleic Acid (cDNA) Microarray|Mature T-cells will be analyzed to identify gene expression changes that correlate with loss of a tumor suppressor gene in a human melanoma cell line.|Day 3-5 after drug administration|This outcome measure was not done because there were inadequate samples to evaluate mature T cell lymphoma malignant cells by cDNA microarray.||||||
2849829|NCT00082017|Other Pre-specified|Effect of UCN-01 on Soluble TAC Cluster of Differentiation 25 (CD25)|Soluble TAC (CD25) levels will be assessed in patients with anaplastic large cell lymphoma.|Day 3-5 after drug administration|This outcome measure was not done because data were insufficient to assess for possible effects on soluble TAC (CD25) levels.||||||
2849830|NCT00082017|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|76 months||||Participants|||Number
2849831|NCT00082017|Primary|Overall Survival (OS)|OS is defined as the date of on-study to the date of death from any cause or last follow up.|55 months||||months||95% Confidence Interval|Median
2849832|NCT00082017|Primary|Progression Free Survival (PFS)|PFS is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression is assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as a ≥50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for partial response's or non-responders or appearance of any new lesion during or at the end of therapy.|3.6 months||||months||95% Confidence Interval|Median
2849833|NCT00082017|Primary|Clinical Response Rate|Clinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is >1.5cm, it must have regressed by >75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module|74.5 months||||Percentage of participants|||Number
2849834|NCT00081861|Primary|Number of Participants With Response (Complete Response or Progressive Disease)|"Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as complete disappearance of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression."|After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),|Two participants received first treatment dose but were not eligible for response.|||Participants|||Number
2849835|NCT00003270|Secondary|Progression-free Survival|time to disease progression or death due to any cause|1 year||||% of participants||95% Confidence Interval|Number
2849836|NCT00003270|Primary|Overall Response Rate|Continuous complete remission (for patients in complete remission before treatment) or induced complete remission (for patients not in complete remission before treatment)|day +100 after Cord Blood Transplant||||Participants|||Count of Participants
2849837|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 2|The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 2|ITT Population defined as subjects who received at least one dose of study medication|||Log10 IU/mL||Standard Deviation|Mean
2849838|NCT00081770|Secondary|Virologic Response Rate at Treatment Week 12|Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12|Assessed at Treatment Week 12|ITT Population defined as subjects who received at least one dose of study medication|||Percentage of participants|||Number
2850230|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849839|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 4|The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 4|ITT Population defined as subjects who received at least one dose of study medication|||Log10 IU/mL||Standard Deviation|Mean
2849840|NCT00081770|Primary|Sustained Virologic Response (SVR) Rate|SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.|Assessed at the end of a 24-week post-treatment follow-up|Intent-to-Treat [ITT] Population defined as subjects who received at least one dose of study medication|||Percentage of participants|||Number
2849841|NCT00081731|Primary|Need for Renal Replacement Therapy||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849842|NCT00081731|Primary|30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849843|NCT00081731|Primary|Stroke||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849844|NCT00081731|Primary|Hospitalization for Congestive Heart Failure||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849845|NCT00081731|Primary|Myocardial Infarction||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849846|NCT00081731|Primary|Cardiovascular or Renal Death||Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849847|NCT00081731|Primary|Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy|Only the first event per participant is included in the composite|Measured at every 3 months for the first year and annually thereafter||||participants|||Number
2849848|NCT00081653|Secondary|Relative Percent Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6,12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percent change||Standard Deviation|Mean
2849849|NCT00081653|Primary|Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)|BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population: n = number of participants analyzed for the given parameter at the specified visit.|||percent change||Standard Deviation|Mean
2849850|NCT00081653|Primary|Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD|Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.|||g/cm^2||Standard Deviation|Mean
2849851|NCT00081653|Secondary|Absolute Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6, 12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||ng/mL||Standard Deviation|Mean
2849852|NCT00081653|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline, 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.|||percent change in BMD||Standard Deviation|Mean
2849853|NCT00081653|Secondary|Absolute Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline and 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.|||g/cm^2||Standard Deviation|Mean
2849854|NCT00081497|Secondary|Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–62 patients had assessments at 6 months, 61 patients had assessments at 12 months, and 54 patients had assessments at 18 months in the open-label extension study.|||urine protein(mg/dL) / creatinine(mg/dL)||Standard Deviation|Mean
2849855|NCT00081497|Secondary|Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL00800 for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL00800; assessment prior to first Fabrazyme infusion in AGAL02503 for placebo patients who did not transition to Fabrazyme in AGAL00800.|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–64 patients had assessments at 6 and 18 months while 65 patients had assessments at 12 months in the open-label extension study.|||µg/mL||Standard Deviation|Mean
2849856|NCT00081497|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-00-800 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.|||ml/min/1.73m^2||Standard Deviation|Mean
2849857|NCT00081497|Secondary|Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.|||mg/dL||Standard Deviation|Mean
2849858|NCT00081497|Post-Hoc|Differences in Slopes of Estimated Glomerular Filtration Rate (eGFR) Comparing Randomized Placebo vs Fabrazyme Patients (Based on the Original Randomization in AGAL-008-00 (NCT00074984)) by Baseline eGFR Subgroups of >60 and ≤60 mL/Min/1.73 m^2.|Summary of differences in slopes of eGFR comparing randomized placebo vs Fabrazyme patients by baseline eGFR subgroups. Differences in slopes are the placebo slope minus the Fabrazyme slope. Therefore, a negative difference indicates a greater decline in the placebo patients relative to the Fabrazyme patients.|Throughout study; 18 months|ITT population. For subgroup Estimated Glomerular Filtration Rate (eGFR) >60, there were 9 placebo patients and 15 Fabrazyme patients. For subgroup eGFR ≤60, there were 19 placebo patients and 24 Fabrazyme patients. For randomized Fabrazyme patients, both the double-blind and open-label data was used.|||mL/min/1.73m^2/year||Standard Error|Least Squares Mean
2849859|NCT00081497|Primary|Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods|The primary efficacy analysis was the summary of change in slope of inverse serum creatinine for Placebo/Fabrazyme patients in the Intent to Treat (ITT) Population. It compared the placebo period slope with the Fabrazyme period slope.|Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)|ITT Population - Analysis compares results during the placebo period with those during the Fabrazyme period and includes only the 28 patients who were randomized to placebo in the AGAL-008-00 (NCT00074984) study; as such no formal sample size calculations were performed.|||dL/mg/year||Standard Error|Least Squares Mean
2849860|NCT00081458|Secondary|Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24|An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.|6 months of treatment||||participants|||Number
2849861|NCT00081458|Primary|A Graded Response Score in Parenteral Nutrition (PN) Reduction|"The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24.~Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%.~One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20.~Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20.~Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20."|6 months|Intent to Treat (ITT) analysis using a stepdown procedure that was stopped if the 0.10 mg/kg dose was not significantly better than placebo.|||participants|||Number
2849862|NCT00081328|Secondary|Comorbidity -- Triglycerides Dyslipidemia|A diagnosis was made by an out-of-range value >=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||participants|||Number
2849863|NCT00081328|Secondary|Comorbidity -- LDL Dyslipidemia|A diagnosis was made from out-of-range value >= 130 mg/dL sustained over 6 months or put on lipid lowering medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||participants|||Number
2849864|NCT00081328|Secondary|Comorbidity -- Hypertension|A diagnosis was made by an out-of-range value >=95th percentile or systolic >=130 or diastolic >=80 sustained over 6 months or on an anti-hypertensive medication.|Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||participants|||Number
2849865|NCT00081328|Secondary|Body Composition -- Fat Mass|Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.|||kg||Standard Deviation|Mean
2849866|NCT00081328|Secondary|Body Composition -- Bone Density|Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.|||g/cm squared||Standard Deviation|Mean
2849867|NCT00081328|Secondary|Body Composition -- Waist Circumference|Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Members of cohort measured at 24 months who had not experience treatment failure.|||cm||Standard Deviation|Mean
2849868|NCT00081328|Secondary|Body Composition -- BMI|Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Cohort measured at 24 months and had not experienced treatment failure.|||kg per meters squared||Standard Deviation|Mean
2850231|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849869|NCT00081328|Secondary|Insulin Secretion|Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experience treatment failure.|||uU/mL divided by mg/dL||Inter-Quartile Range|Median
2849870|NCT00081328|Secondary|Safety|Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.|Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.|Entire cohort.|||episodes of serious adverse event|||Number
2849871|NCT00081328|Secondary|Insulin Sensitivity|All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experienced treatment failure.|||mL/uU||Inter-Quartile Range|Median
2849872|NCT00081328|Primary|Treatment Failure (Loss of Glycemic Control)|Defined as A1c persistently >=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)|Study duration - 2 years to 6.5 years of follow up from randomization|The entire cohort of 699 participants was included in the analysis.|||participants|||Number
2849873|NCT00081289|Secondary|Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years|"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms."|Baseline and two years|Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and two years|||score on a scale||Standard Deviation|Mean
2849874|NCT00081289|Secondary|Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy|"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms."|Baseline and completion of post-operative chemotherapy, approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy|Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and completion of chemoradiation|||score on a scale||Standard Deviation|Mean
2849875|NCT00081289|Secondary|Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation|"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms."|Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization|Eligible patients enrolled after the protocol amendment who have QLQ-C38 defecation score at baseline and completion of chemoradiation|||score on a scale||Standard Deviation|Mean
2849876|NCT00081289|Secondary|Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years|The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.|Baseline and two years|Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of post-operative chemotherapy|||score on a scale||Standard Deviation|Mean
2849877|NCT00081289|Secondary|Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy|The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.|Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy|Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of post-operative chemotherapy|||score on a scale||Standard Deviation|Mean
2849878|NCT00081289|Secondary|Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation|The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms.|Baseline and completion of chemoradiation approximately 6-8 weeks from randomization|Eligible patients enrolled after the protocol amendment who have QLQ-C38 GI score at baseline and completion of chemoradiation|||score on a scale||Standard Deviation|Mean
2849879|NCT00081289|Secondary|Change From Baseline in QLQ-C30 Global Health Status Score at Two Years|"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A negative number indicates improvement in symptoms."|Baseline and two years|Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and two years|||score on a scale||Standard Deviation|Mean
2849880|NCT00081289|Secondary|Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy|"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL."|Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy|Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and completion of post-operative chemotherapy|||score on a scale||Standard Deviation|Mean
2849881|NCT00081289|Secondary|Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation|"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL."|Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization|Eligible patients enrolled after the protocol amendment who have QLQ-C30 Global Health Status score at baseline and completion of chemoradiation|||score on a scale||Standard Deviation|Mean
2849882|NCT00081289|Secondary|Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens||End of study|The data required for this analysis was not obtained and will not be obtained.||||||
2849883|NCT00081289|Secondary|Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively|Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From post-surgery to before chemotherapy (CT), or within 60 days of surgery if no postoperative CT. Approximately 10-16 weeks to 14-22 weeks from randomization based on CT starting 4-6 weeks after surgery.|Eligible patients enrolled after the protocol amendment who had surgery|||Participants|||Count of Participants
2849884|NCT00081289|Secondary|Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively|Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation. If no surgery, then <= 90 days from start of treatment.|Eligible patients enrolled after the protocol amendment|||Participants|||Count of Participants
2849885|NCT00081289|Secondary|Number of Participants With Grade 3+ Treatment-related Adverse Events|Highest grade adverse event per subject were counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to end of follow-up. Maximum follow-up is 5.2 years.|Eligible patients enrolled after the protocol amendment|||Participants|||Count of Participants
2849886|NCT00081289|Secondary|Disease-free Survival Rate at 4 Years|Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.|From randomization to four years|Eligible patients enrolled after the protocol amendment|||percentage of participants||95% Confidence Interval|Number
2849887|NCT00081289|Secondary|Second Primary Rate at 4 Years|Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method.|From randomization to four years|Eligible patients enrolled after the protocol amendment|||percentage of participants||95% Confidence Interval|Number
2849888|NCT00081289|Secondary|Distant Failure Rate at 4 Years|Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method.|From randomization to four years|Eligible patients enrolled after the protocol amendment|||percentage of participants||95% Confidence Interval|Number
2849953|NCT00002540|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
2849889|NCT00081289|Secondary|Local-regional Failure Rate at 4 Years|Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.|From randomization to four years|Eligible patients enrolled after the protocol amendment|||percentage of participants||95% Confidence Interval|Number
2849890|NCT00081289|Secondary|Survival Rate at 4 Years|Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method.|From randomization to four years|Eligible patients enrolled after the protocol amendment|||percentage of participants||95% Confidence Interval|Number
2849891|NCT00081289|Primary|Pathologic Complete Response Rate|"A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR.~Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial."|After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation|For each arm the first 48 eligible enrolled after the protocol amendment.|||percentage of participants||95% Confidence Interval|Number
2849892|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Angiogenisis (VEGF)||Up to 18 weeks|||||||
2849893|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Apoptosis Index (TUNEL Assay)||Up to 18 weeks||2099-01-31|01/2099||||
2849894|NCT00081263|Other Pre-specified|The Number of Quadrants Involving CIN||Up to 18 weeks|||||||
2849895|NCT00081263|Other Pre-specified|Proportion of Patients Whose Eligibility Can be Successfully Determined Using the Web-based Review||Baseline|||||||
2849896|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in Proliferation Index (Ki67).||Up to 18 weeks|||||||
2849897|NCT00081263|Other Pre-specified|To Determine the Feasibility of Digital Imaging Using Pathologist's Diagnosis and Diagnostic Technique (Web-based or Standard Method).||Baseline|||||||
2849898|NCT00081263|Other Pre-specified|Levels of Serum VEGF||Up to 18 weeks|||||||
2849899|NCT00081263|Other Pre-specified|Levels of Serum bFGF||Up to 18 weeks|||||||
2849900|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in the Levels of Celecoxib in Serum During Treatment.||Up to 18 weeks|||||||
2849901|NCT00081263|Other Pre-specified|HPV Viral Load Before and After Treatment||Up to 18 weeks|||||||
2849902|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in HPV Viral Load in Serum Before and After Treatment||Up to 18 weeks|||||||
2849903|NCT00081263|Other Pre-specified|To Examine the Association of Histologic Response in COX-2 in Tissue||Up to 18 weeks|||||||
2849904|NCT00081263|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients.|||participants|||Number
2849905|NCT00081263|Primary|Histologic Regression|Whether or not patients with CIN 2/3 or CIN 3 upon entry experience a complete remission (or partial regression to CIN 1) in the post-treatment excisional biopsy.|Post treatment evaluation was done 14 to 18 weeks after treatment randomization|Eligible, Treated, and Evaluable patients|||percentage of participants||90% Confidence Interval|Number
2849906|NCT00081159|Other Pre-specified|Overall Survival (OS)|Overall Survival defined as the length of time from the start of treatment till time that participants are still alive.|Up to 90 months|Intent to treat population analysis.|||Months||95% Confidence Interval|Median
2849907|NCT00081159|Secondary|Major Bone Scan Response|Bone scan performed at baseline and at Week 13 provided if baseline scan was positive for metastases. A major bone scan response was considered with a substantial resolution of participant bone metastases on the bone scans, i.e. complete resolution of the osseous metastases on the bone scan.|Week 13|Five participants in the non-Strontium arm were not evaluable for this outcome, four withdrew prior to treatment, and one had disease progression that precluded inclusion. Two participants in the Strontium arm were lost to follow up therefore excluded from analysis as well.|||participants|||Number
2849908|NCT00081159|Primary|Progression Free Survival (PFS)|Study's primary endpoint of PFS duration/time to progression was defined as the time from the date of randomization to the date of first evidence of disease progression or patient death. Prostate-specific antigen (PSA) progression is usually the first evidence of progression. PSA progression is defined as a 25% increase over the baseline or the nadir provided that the increase is a minimum of 1 ng/ml.|Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression|Intent to treat population analysis.|||Months||95% Confidence Interval|Median
2849909|NCT00080938|Secondary|Overall Survival Time|Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2849910|NCT00080938|Secondary|Time to Non-CNS (Systemic) Progression|Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2849911|NCT00080938|Secondary|1-year Neurologic (Central Nervous System, CNS) Progression Free Rate|1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease.|assessed every 3 months for 2 years|Eligible, treated patients|||percentage of participants||95% Confidence Interval|Number
2849912|NCT00080938|Primary|Number of Patients With Intracranial Response|Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR|assessed every cycle while on treatment, then every 3 months for 2 years|Eligible and treated patients|||participants|||Number
2849913|NCT00080912|Primary|Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment|The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation. A complete response was defined as a Brief Pain Inventory worst-pain score of zero with no associated increase in daily oral morphine equivalent. A partial response was defined as pain that persisted after treatment, either with a worst-pain score reduction of 2 or more and no increase in daily oral morphine equivalent consumption, or no increase in pain and a reduction in daily oral morphine equivalent consumption of at least 25%.|2 months|Intend to treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2849914|NCT00080899|Secondary|Time to PSA Progression|Was summarized using the product-limit (Kaplan-Meier) method. In patients whose PSA levels initially decreased, PSA progression was defined as a 25% increase over the nadir (postenrollment PSA value up to that point), and an increase in the absolute value in the PSA value of 5 ng/mL, relative to the lowest postenrollment PSA value up to that point, including the baseline PSA level - and which was confirmed by second value 3-4 weeks later. A best response of PSA-PD was recorded for those patients who did not achieve a confirmed PSA-N or PSA-PR and who experienced PSA progression within 3 months of start of treatment.|From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 years||||months||95% Confidence Interval|Mean
2849915|NCT00080899|Primary|PSA Response|PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.|Baseline to 5 years||||participants|||Number
2849916|NCT00080535|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.||||Participants|||Count of Participants
2849917|NCT00080535|Primary|Response Rate|Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.||||Participants|||Number
2849918|NCT00080483|Other Pre-specified|Increased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis||2 years|||||||
2849919|NCT00080483|Other Pre-specified|Improved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging||2 years|||||||
2849920|NCT00080483|Other Pre-specified|Increased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia||2 years|||||||
2849921|NCT00080483|Primary|MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.|Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia|baseline, one year, two years|All subjects who had both baseline and one year evaluations|||unitless||Standard Error|Mean
2849922|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease who had complete disease assessment data|||proportion of participants||95% Confidence Interval|Number
2849923|NCT00002525|Secondary|5-year Overall Survival Rate in Patients With Dukes' B2 Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease|||proportion of participants||95% Confidence Interval|Number
2849954|NCT00002540|Secondary|Prostate Cancer Incidence Rates|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
2849924|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease who had complete disease assessment data|||proportion of participants||95% Confidence Interval|Number
2849925|NCT00002525|Primary|5-year Overall Survival Rate in Patients With Dukes' B3/C Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease|||proportion of participants||95% Confidence Interval|Number
2849926|NCT00080470|Primary|Freedom From Major Complications||5 years||||Number of Adverse Events|||Number
2849927|NCT00080470|Primary|Number of Leaks Per Day||12 months||||Number of Leaks Per Day||Standard Deviation|Mean
2849928|NCT00080301|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.|Analysis was conducted on all randomized participants on an intent to treat basis.(Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)|||units on a scale||95% Confidence Interval|Mean
2849929|NCT00080301|Secondary|Treatment-related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.|||Participants|||Number
2849930|NCT00080301|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.|from date of randomization until death|Overall survival was analyzed on all randomized patients on an intent to treat basis.|||Months||95% Confidence Interval|Median
2849931|NCT00080301|Secondary|Time to Response Per IRRC|Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for time to response apply to only those subjects with a response (defined as complete or partial response)|||weeks||Full Range|Median
2849932|NCT00080301|Secondary|Duration of Response Per IRRC|"Computed for all patients with a best response of Partial or Complete per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death."|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for duration of response apply to only those subjects with a response (defined as complete or partial response).|||months||95% Confidence Interval|Median
2849933|NCT00080301|Secondary|Overall Response Rate (ORR) Per IRRC|"Participants with best response of Complete or Partial according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions"|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|The analysis of ORR was conducted on all randomized patients on an intent to treat basis.|||percent||95% Confidence Interval|Mean
2849934|NCT00080301|Primary|Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)|PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|PFS was analyzed on all randomized patients on an intention to treat basis.|||Months||95% Confidence Interval|Median
2849935|NCT00080288|Primary|Clinical Global Impression of Change (CGI-C)|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."|||Participants|||Number
2849955|NCT00002540|Secondary|Prostate Cancer Incidence|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2849936|NCT00080288|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
2849937|NCT00080223|Secondary|Overall Survival|Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.|First dosing of study treatment until death (up to 604 weeks)|All treated participants|||weeks||95% Confidence Interval|Median
2849938|NCT00080223|Secondary|Resting Oxygen Saturation by Pulse Oximetry (SpO2)|SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.|||percentage of oxygen saturation||Standard Deviation|Mean
2849939|NCT00080223|Secondary|Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)|DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.|||percent predicted DLco||Standard Deviation|Mean
2849940|NCT00080223|Secondary|Percent Predicted Forced Vital Capacity (FVC)|FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.|||percent predicted FVC||Standard Deviation|Mean
2849941|NCT00080223|Primary|Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.|Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)|All treated participants|||percentage of participants|||Number
2849942|NCT00002540|Secondary|T5 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T5 (five years after entry)|All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.|||Participants|||Number
2849943|NCT00002540|Secondary|T4 PSA Screening Result|Prostate-Specific Antigen (PSA) result|T4 (four years after entry)|All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.|||Participants|||Number
2849944|NCT00002540|Primary|Prostate Cancer Death Rates|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.||||Deaths per 10,000 PY|||Number
2849945|NCT00002540|Secondary|T3 DRE Screening Results|Digital Rectal examination (DRE) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.|||Participants|||Number
2849946|NCT00002540|Secondary|T3 PSA Screening Results|Prostate-Specific Antigen (PSA) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.|||Participants|||Number
2849947|NCT00002540|Secondary|T2 DRE Screening Results|Digital Rectal Examination (DRE) results|T2 (two years after entry)|All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.|||Participants|||Number
2849948|NCT00002540|Secondary|T2 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T2 (two years after entry)|All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.|||Participants|||Number
2849949|NCT00002540|Secondary|T1 DRE Screening Results|Digital Rectal Examination (DRE) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.|||Participants|||Number
2849950|NCT00002540|Secondary|T1 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.|||Participants|||Number
2849951|NCT00002540|Secondary|T0 (Baseline) DRE Screening Results|Digital Rectal Examination (DRE) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.|||Participants|||Number
2849952|NCT00002540|Secondary|T0 (Baseline) PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.|||Participants|||Number
2850232|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2849956|NCT00002540|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
2849957|NCT00002540|Secondary|Deaths From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2849958|NCT00002540|Primary|Prostate Cancer Deaths|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2849959|NCT00080119|Secondary|Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Any event of grade 3 or higher not present at entry that occurred after randomization was classified as a new event. Results report percent of participants with a new event by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting treatment. Time from randomization to first new adverse event (AE) calculated. For lab toxicities, censored at visit following permanent discontinuation of study drugs. For signs/symptoms, participants in follow-up at 96 wks (+12) with no new grade >=3 AE censored at 96 wks. Participants LTF <96 wks censored at LTF.|||Percent of participants|||Number
2849960|NCT00080119|Secondary|Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Deaths from any cause were included. Results report percent of participants dying by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to death was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks (+12 wks) censored at 96 weeks. HIVpos on study when study was discontinued were censored at their discontinuation visit.|||Percent of participants|||Number
2849961|NCT00080119|Secondary|Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB infection was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB infection were censored at 96 wks. HIVpos on study when study discontinued censored at their discontinuation visit.|||Percent of participants|||Number
2849962|NCT00080119|Secondary|Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB disease was calculated. Participants LTF <96 wks (+12 wks) censored at time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. HIVpos on study when study discontinued were censored at their discontinuation visit.|||Percent of participants|||Number
2849963|NCT00080119|Secondary|Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVneg who started study treatment. Time from randomization to the first of TB disease/death was calculated. Participants lost-to-follow-up before 96 weeks (+12 week window)were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks who were free of TB disease were censored at 96 weeks (+12 week window).|||Percent of participants|||Number
2849964|NCT00080119|Secondary|Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children|HIV disease progression was defined as any advancement in Centers for Disease Control (CDC) disease category from entry or death. If a participant was CDC disease category C at entry progression was defined as death. Results report percent of participants with HIV progression or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos starting study treatment. Time from randomization to first of disease progression/death calculated. Censored if LTF <96 wks, at 96 wks (if on study) or at discontinuation visit. Participants found to be HIVneg upon repeat testing could only progress by meeting a death endpoint.|||Percent of participants|||Number
2849981|NCT00079781|Primary|Short-term Chronic SAE Rate|"The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.~The primary safety outcome measure was met."|Initial implant through 3 months post-implant||||percentage of participants||95% Confidence Interval|Number
2849965|NCT00080119|Secondary|Time From Randomization to Development of TB Infection or Death Among HIV-infected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVpos starting study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants LTF <96 weeks (+12 wk) censored at the time LTF. Participants in follow-up at 96 wks free of TB infection censored at 96 wks. Participants on study when study discontinued were censored at discontinuation visit.|||Percent of participants|||Number
2849966|NCT00080119|Primary|Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive tuberculin skin test (TST) based on a purified protein derivative (PPD) performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVneg who started study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants lost-to-follow-up before 96 wks were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks (+12 week window) who were free of TB infection were censored at 96 weeks (+12 week window).|||Percent of participants|||Number
2849967|NCT00080119|Primary|Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children|Criteria for diagnosis with TB disease: Definite-isolation of Mycobacterium TB (M.tb) or +ve stain on cerebrospinal fluid (CSF); Probable- +ve acid fast bacilli (AFB) stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of pulmonary TB (PTB) and either a +ve tuberculin skin test (TST) or minimum score on algorithm for clinical TB. Records reviewed by Endpoint Review Group. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos who started study treatment. Time from randomization to TB disease/death was calculated. Participants lost-to-follow-up (LTF) <96 wks (+12wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. Participants on study when study discontinued censored at discontinuation visit.|||Percent of participants|||Number
2849968|NCT00079937|Primary|Percentage of Participants With at Least 1 Adverse Event|See Adverse Events module for details.|Baseline to end of the study (Week 68)|Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment.|||Percentage of participants|||Number
2849969|NCT00079937|Secondary|Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)|PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.|Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2849970|NCT00079937|Secondary|Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Puffs||Standard Deviation|Mean
2849971|NCT00079937|Secondary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.|Baseline to end of the treatment period (Week 52)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Exacerbations per patient per year||95% Confidence Interval|Mean
2849982|NCT00079781|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.~The primary safety outcome measure was met."|Initial implant through 1 month post-implant||||percentage of participants||95% Confidence Interval|Number
2849972|NCT00079937|Primary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.|Baseline to end of the fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Exacerbations per patient per 24-weeks||95% Confidence Interval|Mean
2849973|NCT00079937|Secondary|Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|"Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question How did you sleep last night?, with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement."|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.|||Units on a scale||Standard Deviation|Mean
2849974|NCT00009737|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to Week 29|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment|||Participants|||Number
2849975|NCT00009737|Secondary|Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters|Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.|Up to Week 25|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.|||Participants|||Number
2849976|NCT00009737|Secondary|Mean Change From Baseline in Global Health Status at Week 25|Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.|Baseline (Days -7 to 1) and at Week 25|The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).|||Score on a scale||Standard Error|Mean
2849977|NCT00009737|Secondary|Overall Survival|Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.|||Participants|||Number
2849978|NCT00009737|Secondary|Relapse-Free Survival|Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.|||Participants|||Number
2849979|NCT00009737|Primary|Disease-free Survival|Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.|||Participants|||Number
2849980|NCT00079781|Primary|Responder Rate|"Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more.~The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group.~The primary effectiveness endpoint was met."|Pre-implant baseline through 4 months post-implant||||Percent of participants|||Number
2849999|NCT00079391|Primary|The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30|"The proportion of patients who develop full donor CD3+ lymphocyte chimerism by day 30.~Full chimerism is defined as >95% donor alleles by molecular profiling (Short Tandem Repeat analysis)."|Day 30|Per protocol; only patients who survived to day 30 and were evaluable.|||percentage of participants|||Number
2849983|NCT00079677|Primary|Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|12 weeks or last post-baseline visit|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.~Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."|||Participants|||Number
2849984|NCT00079677|Primary|Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|Change from baseline at 12 weeks or early termination|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.~Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
2849985|NCT00002601|Secondary|5-year Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years||||percentage of participants||95% Confidence Interval|Number
2849986|NCT00002601|Secondary|5-year Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 25% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 Years||||percentage of participants||95% Confidence Interval|Number
2849987|NCT00002601|Primary|Toxicities Counts|Number of patients with grade 3 and 4 toxicities observed during cycles 1 & 2 using the Common Toxicity Criteria Version for Chemotherapy.|2 months after completion of second cycle of treatment.||||Participants|||Count of Participants
2849988|NCT00002601|Primary|Number of Participants With Grade 3 Bilirubin|Criteria for early termination of this feasibility study: > 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; > 2 patients experience grade 3 hepatic or gastrointestinal toxicity or > 3 patients are unable to receive the second cycle of treatment; > 2 patients experience grade 5 toxicity related to treatment regimen.|2 years after completion of treatment||||participants with Grade 3 Bilirubin|||Number
2849989|NCT00079417|Secondary|Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0|Participants with Grade 3 and higher reported on protocol therapy|6 months after enrollment|All eligible patients are reported. 7 patients were excluded due to ineligible status.|||Participants|||Number
2849990|NCT00079417|Secondary|Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level|EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction|2 years after enrollment|There were 15 eligible patients who responded to vincristine and carboplatin after an initial 1 cycle of therapy. 7 patients were excluded due to ineligible status.|||Proportion of participants||95% Confidence Interval|Number
2849991|NCT00079417|Secondary|Response Rate (RR) at Eye Levels After the First Course of Therapy|RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number eyes with Type I, II, III or IV response after first course of therapy|1 month after enrollment|Number of Group B eyes for the eligible patients. 4 patients were excluded due to ineligible status.|||Proportion of eyes||95% Confidence Interval|Number
2849992|NCT00079417|Secondary|Response Rate (RR) at Patient Level After the First Course of Therapy|RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number of patients with Type I, II, III or IV response after first course of therapy|1 month after enrollment|All eligible patients are reported. 7 patients were excluded due to ineligible status.|||Proportion of participants||95% Confidence Interval|Number
2849993|NCT00079417|Primary|Event-free Survival|Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.|At 2 years|All eligible patients are reported. 7 patients were excluded due to ineligible status. Of the 7 patients, 1 was determined to have only a Group A involved eye and the other 6 had an intact eye that was Group C or D.|||Proportion of participants||95% Confidence Interval|Number
2849994|NCT00079391|Secondary|Acute GVHD Overall|Incidence of acute GVHD grades II-IV (before and after T cell add back) Modified Glucksberg grading|First 100 days||||participants|||Number
2849995|NCT00079391|Secondary|Acute Graft Versus Host Disease (Before Day 60 T Cell Add Back)|"Incidence of acute Graft versus host disease (GVHD) grades II-IV (before day 60 T cell add back)~Modified Glucksberg grading"|First 60 days|Per protocol|||participants|||Number
2849996|NCT00079391|Secondary|Cumulative Incidence of Relapse|Kaplan Meier-estimate of relapse incidence|at 5 years post transplant||||percentage of participants|||Number
2849997|NCT00079391|Secondary|Non Relapse Mortality.|"Non relapse mortality: death without relapse~Kaplan Meier estimate"|at 5 years post transplant||||percentage of participants|||Number
2849998|NCT00079391|Secondary|Overall Survival|Kaplan Meier estimate of survival|at 5 years post transplant||||percentage of participants|||Number
2850000|NCT00079339|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/white matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.|||Ratio||Full Range|Median
2850001|NCT00079339|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.|||Ratio||Full Range|Median
2850002|NCT00079339|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline and within two weeks after completion of radiation.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline volume FLAIR value and a second volume FLAIR value measured at approximately 8 weeks after starting treatment.|||cubic centimeters||Full Range|Median
2850003|NCT00079339|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation.|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Diffusion values are obtained from magnetic resonance diffusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline diffusion ratio value and a second diffusion ratio value measured at approximately 8 weeks after starting treatment.|||Ratio||Full Range|Median
2850004|NCT00079339|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Perfusion values are obtained from magnetic resonance perfusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline perfusion ratio value and a second perfusion ratio value measured at approximately 8 weeks after starting treatment.|||Ratio||Full Range|Median
2850005|NCT00079339|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks.|Per protocol 40 participants who received at least one dose of tipifarnib were needed for this objective. The analysis population consists of phase I participants treated at the maximum tolerated dose (MTD) and the participants enrolled to the phase II part.|||Months||Full Range|Median
2850006|NCT00079339|Primary|Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.|Day 1 of tipifarnib therapy to week 8|Per protocol, participants included phase I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.|||Participants|||Number
2850007|NCT00079326|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.|up to 6 years||||months||95% Confidence Interval|Median
2850008|NCT00079326|Primary|Overall Response Rate|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.|Up to 6 years||||percentage of participants||95% Confidence Interval|Number
2850020|NCT00079183|Secondary|Secondary Malignancies|Proportion of participants who developed at least one secondary malignancy by 7 years|Up to 7 years||||Participants|||Count of Participants
2850021|NCT00079183|Secondary|Proportion With Infections Categorized by Organism||Approximately 7 years||||Participants|||Count of Participants
2850022|NCT00079183|Secondary|Proportion of Patients Who Discontinue Administration of Sirolimus Because of Toxicity||Approximately 7 years||||Participants|||Count of Participants
2850009|NCT00079274|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients)|The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.|Assessed up to 8 years|All patients that were mutant KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint.|||percentage of patients|||Number
2850010|NCT00079274|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients)|The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.|Assessed up to 8 years|All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint.|||percentage of patients|||Number
2850011|NCT00079274|Secondary|Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients)|Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event-free rates (percentage) are report below for mutant KRAS patients.|Up to 3 years|The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
2850012|NCT00079274|Secondary|Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients)|Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event free rates (percentage) are reported below for Wild-type KRAS Patients.|Up to 3 years|The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
2850013|NCT00079274|Secondary|Disease-free Survival (Arms A and D: Mutant KRAS Patients)|"A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.~Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
2850014|NCT00079274|Primary|Disease-free Survival (Arms A and D: Wild-type KRAS Patients)|"The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.~Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.|||percentage of participants||95% Confidence Interval|Number
2850015|NCT00079183|Secondary|Probability of Cumulative Incidence of Recurrent Malignancy|Analyzed with death as a competing risk factor. Assessed at 7 years.|Approximately 7 years||||probability||95% Confidence Interval|Number
2850016|NCT00079183|Secondary|Probability of Cumulative Incidence of Death Without Recurrent Malignancy|Analyzed with recurrent malignancy as a competing risk factor. Assessed at 7 years.|Approximately 7 years||||probability||95% Confidence Interval|Number
2850017|NCT00079183|Secondary|Probability of Overall Survival|Kaplan-Meier estimate assessed at 7 years|Approximately 7 years||||survival probability||95% Confidence Interval|Number
2850018|NCT00079183|Secondary|Probability of Survival Without Recurrent Malignancy|Kaplan-Meier estimate assessed at 7 years for probability of survival without recurrent malignancy.|Approximately 7 years||||disease free survival probability||95% Confidence Interval|Number
2850019|NCT00079183|Secondary|Duration of Treatment With Prednisone||Approximately 7 years||||Months||Full Range|Mean
2850023|NCT00079183|Primary|Number of Participants With Recurrent Malignancy|Defined as clinical or histopathologic evidence demonstrating the presence of any malignancy considered as the indication for transplant. Recurrent malignancy will also be defined as any post-transplant intervention not routinely used to prevent the development of overt recurrence, prompted by laboratory evidence of persisting malignant cells but without clinical or histopathologic evidence of recurrence.|Approximately 7 years||||Participants|||Count of Participants
2850024|NCT00079183|Primary|Number of Participants Needing Additional Systemic Therapy|Includes any intervention intended to control chronic GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not originally given under auspices of this protocol.|Approximately 7 years||||Participants|||Count of Participants
2850025|NCT00079183|Primary|Number of Participants Experiencing Treatment Failure|Defined as the initiation of additional systemic therapy, development of bronchiolitis obliterans, or death from causes other than recurrent malignancy during primary treatment for chronic GVHD, whichever occurs first.|Approximately 7 years||||Participants|||Count of Participants
2850026|NCT00079183|Primary|Number of Participants Experiencing Treatment Success|Defined as the absence of any immunosuppressive treatment, including sirolimus, with resolution of all reversible manifestations of chronic GVHD and no additional systemic therapy.|Approximately 7 years||||Participants|||Count of Participants
2850027|NCT00079040|Secondary|Best Objective Response|Number of patients with complete or partial response by RECIST criteria.|Assessed every 6 weeks|Per protocol, the analysis included all eligible, treated patients.|||Patients Responding|||Number
2850028|NCT00079040|Secondary|Overall Survival|Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|Per protocol, the analysis included all eligible, treated patients|||months||95% Confidence Interval|Median
2850029|NCT00079040|Primary|Percentage of Participants Alive and Progression-free (PF) at 6 Months|Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.|6 months|Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).|||Percentage of Participants||95% Confidence Interval|Mean
2850030|NCT00079001|Secondary|Progression-free Survival|"Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.~Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment."|Up to 10 years||||months||95% Confidence Interval|Median
2850031|NCT00079001|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years||||months||95% Confidence Interval|Median
2850032|NCT00079001|Primary|Time to First Skeletal Related Event|Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years||||months||95% Confidence Interval|Median
2850033|NCT00078949|Secondary|Toxic Effect|Number of patients affected by adverse events graded according to CTC Version 2.0. See adverse event (others) for details.|48 months|All patients who received the protocol treatment.|||Participants|||Count of Participants
2850034|NCT00078949|Primary|Event-free Survival of Patients on Maintenance Randomization (Period 2)|Number of patients who develop EFS event during maintenance randomization (period 2)|during the period 2 (up to10 years)|ITT population|||participants|||Number
2850035|NCT00078949|Primary|Transplantation Rate of Patients After 2 Courses of Chemotherapy|Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients|During period 1 (salvage chemotherapy)||||percentage of transplantation|||Number
2850036|NCT00078949|Primary|Response Rate of Patients After 2 Courses of Chemotherapy|The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).|After 2 cycle of treatment|ITT population|||percentage of response|||Number
2850037|NCT00078897|Primary|Median Selenium Blood Levels at One Year.|Adequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year.|One year||||ng/mL||Inter-Quartile Range|Median
2850038|NCT00078897|Primary|Number of Recurrent Adenomas at Surveillance Colonoscopy|Detection of metachronous colorectal adenomas during follow-up, by treatment, in the original cohort. Surveillance colonoscopy is recommended 3 to 5 years after removal of colorectal adenoma(s). Participants will remain on the study intervention until their surveillance colonoscopy. Surveillance colonoscopy is determined by participants' GI physician.|3 to 5 years after baseline colonoscopy||||Adenomas|||Number
2850039|NCT00078819|Secondary|Etanercept Serum Concentration|Serum concentrations for etanercept were measured by using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.627 ng/mL.|Day 1 (predose), week 12, week 24, and week 48|"Participants assigned to etanercept at any time during the study, with available data.~Week 12 excludes participants assigned to placebo who escaped to etanercept. Week 48 includes participants randomized to etanercept at week 36 and remaining on etanercept to week 48. Participants randomized to placebo and retreated with etanercept are excluded."|||ng/mL||Standard Deviation|Mean
2850080|NCT00078559|Secondary|Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status|"Participants who experienced graft loss[1] during study~[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation"|Transplantation to Graft Loss (up to four years post-transplantation)|Intent-to-treat|||participants|||Number
2850040|NCT00078819|Secondary|Number of Participants With Adverse Events During the Double-blind Treatment Period|"The severity assessment for adverse events and infections was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 0 = no toxicity, Grade 1 = mild toxicity, Grade 2 = moderate toxicity, Grade 3 = severe toxicity, Grade 4 = life-threatening toxicity.~Serious adverse events were any events that suggested a significant hazard or side effect, regardless of the investigator's or sponsor's opinion on the relationship to study medication. These included, but were not limited to, events at any dose that were fatal, life threatening, required in-patient hospitalization or prolonged hospitalization, were a persistent or significant disability/incapacity, or were a congenital abnormality/birth defect. Medical events that jeopardized a participant, required intervention to prevent one of the above outcomes, or resulted in urgent investigation could be considered serious."|12 weeks|The safety population included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2850041|NCT00078819|Secondary|Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12|"The percentage of participants who achieved 90% or greater improvement from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Participants who entered the escape arm or had missing data at week 12 were considered non-responders."|Baseline and week 12|Intent-to-treat population|||percentage of participants|||Number
2850042|NCT00078819|Secondary|Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12|"The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.~Participants who entered the escape arm or who had missing data at week 12 were considered to have 0% improvement from baseline."|Baseline and week 12|Intent-to-treat population with available CDLQI data at baseline|||percent improvement||Standard Error|Mean
2850043|NCT00078819|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12|"The sPGA is a static measurement based on induration, erythema, and scaling. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).~Participants who entered the escape arm or had missing data at week 12 were considered non-responders."|Week 12|Intent-to-treat population|||percentage of participants|||Number
2850044|NCT00078819|Secondary|Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12|"The percentage of participants who achieved 50% or greater improvement from baseline in PASI score after 12 weeks of treatment. PASI is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Participants who entered the escape arm or had missing data at week 12 were considered non-responders."|Baseline and week 12|Intent-to-treat population|||percentage of participants|||Number
2850045|NCT00078819|Primary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12|"The percentage of participants who achieved 75% or greater improvement (decrease) from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Participants who entered the escape arm or had missing data at week 12 were considered non-responders."|Baseline and week 12|The intent-to-treat population included all randomized participants.|||percentage of participants|||Number
2850046|NCT00078806|Secondary|Change From Baseline in C-reactive Protein (CRP) Levels in Part 2||Baseline and months 5, 6, 7, 8, and 9|Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status.|||mg/dL||Standard Deviation|Mean
2850047|NCT00078806|Secondary|Change From Baseline in C-reactive Protein (CRP) Levels in Part 1||Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point.|||mg/dL||Standard Deviation|Mean
2850048|NCT00078806|Secondary|Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2|Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do).|Baseline and months 5, 6, 7, 8, and 9|Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status.|||units on a scale||Standard Deviation|Mean
2850049|NCT00078806|Secondary|Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1|Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do).|Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2850050|NCT00078806|Secondary|Change From Baseline in Number of Joints With Limitation of Motion in Part 2||Baseline and months 5, 6, 7, 8, and 9|Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status.|||joints||Standard Deviation|Mean
2850051|NCT00078806|Secondary|Change From Baseline in Number of Joints With Limitation of Motion in Part 1||Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point.|||joints||Standard Deviation|Mean
2850052|NCT00078806|Secondary|Change From Baseline in Number of Active Joints in Part 2|Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth.|Baseline and months 5, 6, 7, 8, and 9|Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status.|||active joints||Standard Deviation|Mean
2850053|NCT00078806|Secondary|Change From Baseline in Number of Active Joints in Part 1|Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth.|Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point.|||active joints||Standard Deviation|Mean
2850054|NCT00078806|Secondary|Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2|Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).|Baseline and months 5, 6, 7, 8, and 9|Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status.|||units on a scale||Standard Deviation|Mean
2850055|NCT00078806|Secondary|Change From Baseline in Patient's/Parent's Global Assessment in Part 1|Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).|Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2850056|NCT00078806|Secondary|Change From Baseline in Physician Global Assessment of Disease Severity in Part 2|Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).|Baseline and months 5, 6, 7, 8, and 9|Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status.|||units on a scale||Standard Deviation|Mean
2850057|NCT00078806|Secondary|Change From Baseline in Physician Global Assessment of Disease Severity in Part 1|Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).|Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9|Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2850058|NCT00078806|Secondary|Time to Flare in Part 2|Time to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during Part 2.|From first dose in Part 1 to the end of Part 2 (up to 13 months)|Participants randomized in Part 2 with a flare in Part 2|||days||Full Range|Median
2850059|NCT00078806|Secondary|Number of Participants With Adverse Events||Part 1A, maximum duration on treatment was 207 days; Part 1B, maximum duration on treatment was 120 days; Part 2, maximum duration on treatment was 88 days; Part 3, maximum duration on treatment was 130 days; plus 30 days after last dose of study drug.|Participants who entered each part of the study and received study drug in each part of the study.|||Participants|||Count of Participants
2850060|NCT00078806|Primary|Number of Participants in Part 2 With Disease Flare|"Disease flare was defined as the presence of:~1 major flare criterion plus 1 minor flare criterion or 1 lab criterion, OR~2 minor flare criteria plus 2 lab criteria~Major Criteria:~Fever of SOJRA, defined as a spike in axillary temperature ≥ 100°F (38°C) for ≥ 2 days per week in the prior 2 weeks or 8 days during the prior month~Symptomatic serositis documented by x-ray or other imaging modality Minor Flare Criteria~Rash of SOJRA, documented in the daily diary~Splenomegaly defined as spleen palpable > 2 cm below the left costal margin~Lymphadenopathy defined as ≥ 1 cm in > 1 node area~Arthritis defined as ≥ 2 active joints with swelling not due to deformity, or if swelling is absent, then 2 joints with loss of motion with pain on passive motion and/or warmth.~Laboratory Criteria:~All labs should be outside the normal range and with 30% worsening:~Albumin~Platelet count~Hemoglobin~C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)"|3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)|Participants randomized into Part 2 who received at least 1 dose of study drug in Part 2 (placebo or etanercept).|||Participants|||Count of Participants
2850061|NCT00078767|Secondary|Incidence of Suicidality|Change in degree of suicidal ideation during study|Up to 39 months||||Participants|||Count of Participants
2850062|NCT00078767|Secondary|Global Impairment|Change in Children's Global Assessment Scale (CGAS) between the two groups|Up to 39 months|There were two categories of depression: participants that had clinical signs of impairment at the time of enrollment as evidenced by their CGAS scores, and participants that did not have clinical signs of depression. Participants clinical symptoms were tested to see if their status changed during the trial.|||Participants|||Count of Participants
2850063|NCT00078767|Secondary|Anxiety Symptoms|"Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial."|Up to 39 months|There were two categories of anxiety symptoms: participants that had clinical signs of anxiety at the time of enrollment as evidenced by their SCARED scores, and participants that did not have clinical signs of depression. Participants with clinical symptoms category were tested to see if their status changed during the trial.|||Participants|||Count of Participants
2850064|NCT00078767|Secondary|Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms|Change in depressive symptoms as determined by change in score|Up to 39 months|"There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial."|||Participants|||Count of Participants
2850065|NCT00078767|Primary|Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD|Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.|Up to 39 months||||Participants|||Count of Participants
2850066|NCT00078754|Secondary|Treatment Response, Assessed as a Function of the Severity of Lifetime Aggressiveness of the Participant and as a Function of the Pretreatment Status of the Central 5-HT Receptor System||Measured at Week 12|||||||
2850067|NCT00078754|Primary|Overt Aggression Scale-Modified (OAS-M)|OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.|Measured at Week 12||||units on a scale||Standard Error|Mean
2850068|NCT00078728|Primary|Child Anxiety Diagnoses|The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.|12 months||||participants|||Number
2850069|NCT00078728|Primary|Number of Children With Child Anxiety Diagnosis|Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.|12 month||||participants|||Number
2850070|NCT00078715|Primary|Hamilton Depression Rating Scale (6 Items)|The 6 item Hamilton Depression Rating Scale is a measurement of the severity of depression with a range of scores from 0 to 24, where 24 indicates the most severe depression.|Once per day, where the primary comparison involves an average over the full study after controlling for baseline||||Units on a scale||Standard Error|Mean
2850071|NCT00005947|Secondary|Overall Survival|Overall Survival|From randomization to 36 months||||Months||95% Confidence Interval|Median
2850072|NCT00005947|Primary|Time to Objective Disease Progression|The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).|36 months from randomization|all randomized participants|||Weeks||95% Confidence Interval|Median
2850073|NCT00078559|Secondary|Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status|Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 - 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||mg/dL||Standard Deviation|Mean
2850074|NCT00078559|Secondary|Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status|Side effects of conventional immunosuppression include increased body weight and hypertension|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||side effects|||Number
2850075|NCT00078559|Secondary|Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||adverse events|||Number
2850076|NCT00078559|Secondary|Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||adverse events|||Number
2850077|NCT00078559|Secondary|Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||adverse events|||Number
2850078|NCT00078559|Secondary|Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status|"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy~1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Intent-to-treat|||participants|||Number
2850079|NCT00078559|Secondary|Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status|"Participants who experienced severe acute rejections[1] during study~Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to severe acute rejection (up to four years post-transplantation)|Intent-to-treat|||Rejection Events|||Number
2850082|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period|"Time (days) to acute rejection[1] for participants occurring during the year following transplantation~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to one year post-transplant)|Participants with acute rejections for whom sirolimus withdrawal was not initiated|||Days|||Number
2850083|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated|"Time (days) to acute rejection[1] for participants where sirolimus was not initiated~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Participants for whom sirolimus withdrawal was not initiated|||Days|||Number
2850084|NCT00078559|Secondary|Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study|"Acute rejections[1] between initiation of sirolimus withdrawal and end of study~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Initiation of sirolimus to end of study (up to four years post-transplant)|Sirolimus withdrawal initiation participant sample|||Rejection Events|||Number
2850085|NCT00078559|Secondary|Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal|"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat|||Rejection Events|||Number
2850086|NCT00078559|Primary|Number of Acute Rejections in All Enrolled Participants|"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)~Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Four years post-transplant|Intent-to-treat|||Rejection Events|||Number
2850087|NCT00002597|Secondary|Positive Re-biopsy Rate at Two Years|The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.|From registration to two years|All eligible patients who had a repeat biopsy at 2 years.|||percentage of participants|||Number
2850088|NCT00002597|Secondary|Disease-free Survival Rate (10 Years)|Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850089|NCT00002597|Secondary|Second Biochemical Relapse Rate (10 Years)|Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850090|NCT00002597|Secondary|Clinical Relapse Rate (10 Years)|Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850091|NCT00002597|Secondary|Biochemical Failure Rate (10 Years)|The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of >2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850092|NCT00002597|Secondary|Distant Failure Rate (10 Years)|Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850093|NCT00002597|Secondary|Local Progression Rate (10 Years)|Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850094|NCT00002597|Secondary|Disease-specific Survival Rate (10 Years)|Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.|From registration to 10 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850096|NCT00078377|Primary|Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis."|||Participants|||Number
2850097|NCT00078377|Primary|Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
2850098|NCT00078338|Primary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.|Baseline up to 96 weeks|The ITT population consisted of all subjects who were randomized.|||days||Standard Deviation|Mean
2850099|NCT00076687|Secondary|Change From Baseline in Ashworth Scale|Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.|Baseline, Week 6|Intent to Treat|||Number on a scale||Standard Deviation|Mean
2850100|NCT00076687|Secondary|Change From Baseline in FEV1/FVC Ratio|Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.|Baseline, Week 6|Safety|||Ratio||Standard Deviation|Mean
2850101|NCT00076687|Primary|Change From Baseline in Forced Expiratory Volume (FEV1)|Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety|||Liters of air||Standard Deviation|Mean
2850102|NCT00076687|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety|||Liters of air||Standard Deviation|Mean
2850103|NCT00078403|Secondary|Weight|Participant weight in kilograms.|Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had weight available. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.|||kilograms||Inter-Quartile Range|Median
2850104|NCT00078403|Secondary|Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)|Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment|At any time after pre-assignment|All Arm A, B and C participants|||Participant|||Number
2850105|NCT00078403|Secondary|Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol|Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
2850106|NCT00078403|Secondary|Sustained Virologic Response|Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation.|24 weeks after end of treatment|All Arm A, B and C participants|||Participant|||Number
2850107|NCT00078403|Secondary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was evaluated by HOMA-IR, calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had HOMA-IR result available. In Arm C, metabolic testing was only performed on participants who enrolled under protocol version 1.0. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.|||mg/dL x uIU/mL||Inter-Quartile Range|Median
2850108|NCT00078403|Secondary|Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)|A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.|Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84|All Arm A, B, and C participants|||Participant|||Number
2850109|NCT00078403|Secondary|HCV-specific Immune Response in Intrahepatic Lymphocytes|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.||||||
2850110|NCT00078403|Secondary|HCV Polymorphisms|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.||||||
2850111|NCT00078403|Secondary|Number of Participants Adherent to Study Medications|A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.|Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.|All Arm A and Arm C participants. Arm B participants did not receive treatment.|||Participant|||Number
2850112|NCT00078403|Secondary|Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations|3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.|Up to 96 Weeks|All Arm A and C participants. Arm B participants did not receive treatment.|||Participant|||Number
2850113|NCT00078403|Secondary|Number of Participants With High-grade Signs and Symptoms or Laboratory Values|Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.|Up to 96 Weeks|All Arm A, B and C participants|||Participant|||Number
2850114|NCT00078403|Secondary|Number of Participants With Depression and/or Other Psychological Events|Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
2850115|NCT00078403|Secondary|Number of Participants With Thrombocytopenia|Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm^3; Grade 2 = 50,000 to 74,999 /mm^3; Grade 3 = 20,000 to 49,999 /mm^3; Grade 4 = below 20,000 /mm^3.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
2850116|NCT00078403|Secondary|Number of Participants With Neutropenia|Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm^3; Grade 2 = 750 to 999 /mm^3; Grade 3 = 500 to 749 /mm^3; Grade 4 = below 500 /mm^3.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
2850117|NCT00078403|Secondary|Number of Participants With Anemia|Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.|Up to 96 weeks|All Arm A, B and C participants|||Participant|||Number
2850118|NCT00078403|Secondary|Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)|Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.|Baseline and at week 72 or premature discontinuation|All participants with SCIIS available (Complete Cases)|||Ishak units per one year (52 weeks)||Inter-Quartile Range|Median
2850119|NCT00078403|Secondary|Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)|Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.|Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84|All Arm A, B and C participants|||Participant|||Number
2850120|NCT00078403|Primary|Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)|SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).|Baseline and at week 72 or premature discontinuation|62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).|||Metavir units per one year (52 weeks)||Inter-Quartile Range|Median
2850133|NCT00077974|Secondary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death|ITT|||weeks||95% Confidence Interval|Median
2850121|NCT00078325|Primary|Clinical Global Impression of Change (CGI-C)|The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)|||Participants|||Number
2850122|NCT00078325|Primary|Maintenance of Wakefulness Test (MWT)|The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.|change from baseline at 12 weeks|"Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)~Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy."|||Minutes||Standard Deviation|Mean
2850123|NCT00078312|Primary|Safety and Tolerability as Measured by Number of Participants With Adverse Events|Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter|Safety Analysis set of 323 total patients: 5 participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant)|||Participants|||Number
2850124|NCT00078286|Secondary|Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.|Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.|Measured at Week 12|Analysis was based on intent to treat (ITT).|||percentage of participants|||Number
2850125|NCT00078286|Primary|Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo|"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.~The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period."|Measured at Week 12|Analysis was based on intent to treat (ITT), using random coefficient modeling.|||HDRS Change Score||Standard Deviation|Mean
2850126|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
2850127|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
2850128|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
2850129|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite|Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
2850130|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Metabolite|Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
2850131|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib|Observed plasma trough (predose) (Cmin) concentrations of sunitinib|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population|||nanograms per milliliter||Standard Deviation|Mean
2850132|NCT00077974|Secondary|Percent Chance of Patient Survival|Probability of survival 1 year and 2 years after the first dose of study treatment|From start of study treatment until death|ITT|||percent chance of survival|||Number
2850233|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2850134|NCT00077974|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).|From start of study treatment until death|ITT|||weeks||95% Confidence Interval|Median
2850135|NCT00077974|Secondary|Duration of Response (DR)|"Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.~DR was calculated for the subgroup of patients with a confirmed objective tumor response."|Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer|ITT subgroup of patients with a confirmed objective tumor response|||weeks||95% Confidence Interval|Median
2850136|NCT00077974|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|ITT|||weeks||95% Confidence Interval|Median
2850137|NCT00077974|Primary|Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)|Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.|||participants|||Number
2850138|NCT00077857|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event Section."|First study drug intake until last study drug intake plus 28 days|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.|||Participants|||Number
2850139|NCT00077857|Secondary|Overall Survival|Overall Survival was measured as the time from the date of randomization to the date of death.|Throughout the study. Median observation time was approximately 16 months.|Intent to treat population included all randomized participants.|||Months||95% Confidence Interval|Median
2850140|NCT00077857|Secondary|Time to Treatment Failure|"The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:~adverse events~insufficient therapeutic response (disease progression)~death~failure to return~refusing treatment/being unwilling to cooperate~withdrawing consent."|Until premature withdrawal or end of primary study treatment (up to 16 cycles).|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.|||Months||95% Confidence Interval|Median
2850141|NCT00077857|Secondary|Duration of Overall Response|Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.|Until PD or death. Median duration of response was approximately 7 months.|Intent to treat population included all randomized participants.|||Months||95% Confidence Interval|Median
2850142|NCT00077857|Secondary|Time to Overall Response|For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.|Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
2850143|NCT00077857|Secondary|Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)|According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.|Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2850144|NCT00077857|Primary|Time to Progression of Disease or Death|Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.|Event driven (after 350 events). Median observation time was approximately 16 months.|Per protocol population included all participants who received at least one dose of study and who did not have any major protocol deviations.|||Months||95% Confidence Interval|Median
2850161|NCT00077649|Secondary|Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period|Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.|Week 60|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
2850145|NCT00077766|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths|An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
2850146|NCT00077766|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).|||beats per minute||Standard Deviation|Mean
2850147|NCT00077766|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
2850148|NCT00077766|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/liter [L]), platelets (100 - 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 - 220 U/L), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time points were included in the analysis (n).|||Participants|||Number
2850149|NCT00077766|Secondary|Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods|A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).|Week 1 to Week 36|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
2850150|NCT00077766|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration|The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population was defined as all randomized participants. Participants with available data at the time of evaluation were analyzed.|||Participants|||Number
2850151|NCT00077766|Primary|Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The per protocol population was all randomized and treated participants, except those who had not met criteria for stable baseline Hb,and adequate iron levels or had hemoglobinopathies/hemolysis, RBC transfusion/blood loss, <5 recorded Hb values during evaluation or missed administrations of trial drugs in week 26 to 35.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2850152|NCT00077922|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|54 months||||Participants|||Number
2850153|NCT00077922|Primary|Response Rate|Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to <1.0cm of 1-1.5cm at baseline, or <1.5cm if >1.5cm at baseline. Partial response is >=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is >=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be >=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months.||||Participants|||Number
2850154|NCT00077675|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.~Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit~Indeterminate: Inability to determine outcome."|7 to 14 days following completion of antibiotic treatment|"The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."|||participants|||Number
2850155|NCT00077649|Primary|Percentage of Participants With Predicted Sustained Virological Response|"The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under Distribution of the predicted probability of an SVR."|Week 4 and 12|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants|||Number
2850156|NCT00077649|Primary|Percentage of Participants With Virological Response Over Time to Week 24|Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.|72 hours post-dose, Weeks 1, 2, 4, 12, and 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
2850157|NCT00077649|Secondary|Total BDI-II (Beck Depression Inventory) Scores|The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.|From Baseline (Day 1) to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2850158|NCT00077649|Secondary|Percentage of Participants With Abnormal Vital Signs|Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.|Up to Week 72|"The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.~."|||percentage of participants|||Number
2850159|NCT00077649|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+).|Up to Week 60|"The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis.~."|||percentage of participants|||Number
2850160|NCT00077649|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 72|"The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.~."|||percentage of participants|||Number
2850162|NCT00077649|Secondary|Percentage of Participants With Virological Response at the End of the Treatment Period|Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.|Week 48|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
2850163|NCT00077649|Secondary|Percentage of Participants With Sustained Virological Response|SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.|Week 72|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||percentage of participants||95% Confidence Interval|Number
2850164|NCT00077649|Primary|HCV RNA Profile During The First 24 Weeks|Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).|Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.|||log 10 copies/mL||Standard Deviation|Mean
2850165|NCT00077636|Secondary|Number of Participants With Highest Triglyceride Level|Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.|Up to Week 40 and Week 48|The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||participants|||Number
2850166|NCT00077636|Secondary|Participants With Marked Abnormal Vital Signs|Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||participants|||Number
2850167|NCT00077636|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||Percentage of participants|||Number
2850168|NCT00077636|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.|||Percentage of participants|||Number
2850169|NCT00077636|Secondary|Percentage of Participants Virological Response 12 Weeks Post-Treatment|Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.|Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.|||Percentage of participants|||Number
2850170|NCT00077636|Secondary|Percentage of Participants With Virological Response at The End of Study Treatment|Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.|Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.|||Percentage of participants|||Number
2850171|NCT00077636|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.|Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)|Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.|||percentage of participants|||Number
2850182|NCT00077610|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||beats per minute (bpm)||Standard Deviation|Mean
2850172|NCT00077623|Secondary|Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants|Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.|||BpM||Standard Deviation|Mean
2850173|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.|||mm HG||Standard Deviation|Mean
2850174|NCT00077623|Secondary|Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants|Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.|||BpM||Standard Deviation|Mean
2850175|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.|||mmHG||Standard Deviation|Mean
2850176|NCT00077623|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/L), platelets (100 - 550 10^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP [0 - 220 U/L]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).|Up to week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as ‘n'.|||participants|||Number
2850177|NCT00077623|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to week 52|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
2850178|NCT00077623|Secondary|Number of Participants With Red Blood Cell Transfusions|The number of participants who received RBC transfusions were reported.|Up to Week 36|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
2850179|NCT00077623|Secondary|Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.|Evaluation period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population included all randomized participants.|||participants|||Number
2850180|NCT00077623|Primary|Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to stable baseline Hb values, inadequate iron status, hemoglobinopathies/hemolysis, RBC transfusion/blood loss, with <5 recorded Hb values during the evaluation period, with missing administrations of the study drug/ reference drug|||g/dL||Standard Deviation|Mean
2850181|NCT00077610|Secondary|Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Upto Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||participants|||Number
2850183|NCT00077610|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2850184|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||participants|||Number
2850185|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).|||participants|||Number
2850186|NCT00077610|Secondary|The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods|The number of participants who received RBC transfusions during the titration and evaluation periods were reported .|Week 1 to Week 36|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.|||participants|||Number
2850187|NCT00077610|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.|The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.|Baseline, Week 29 to Week 36|The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively.|||participants|||Number
2850188|NCT00077610|Primary|Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period|A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.|Baseline, Week 29 to Week 36|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to Hb parameters and <5 recorded Hb values during the evaluation period with missing administrations of the study drug/ reference drug. Please refer to the outcome measure description section for more details.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2850189|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for All Treated Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All treated patients|||Percentage of Participants||95% Confidence Interval|Number
2850190|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for HER2+ Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|HER2+ patients|||Percentage of Participants||95% Confidence Interval|Number
2850191|NCT00077376|Secondary|Time to Treatment Failure for All Treated Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|All treated patients|||Months||95% Confidence Interval|Median
2850192|NCT00077376|Secondary|Time to Treatment Failure for HER2+ Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|HER2+ patients|||Months||95% Confidence Interval|Median
2850193|NCT00077376|Secondary|Time to Disease Progression for All Treated Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients|||Months||95% Confidence Interval|Median
2850194|NCT00077376|Secondary|Time to Disease Progression for HER2+ Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients|||Months||95% Confidence Interval|Median
2850195|NCT00077376|Secondary|Objective Response for All Treated Patients (the Best Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.~The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients|||Participants|||Number
2850196|NCT00077376|Primary|Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.~The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients|||Participants|||Number
2850197|NCT00077207|Secondary|Total Number of Patients Experiencing a Response|Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.|Up to 18 months of protocol therapy|Sixty-five (65) eligible patients were enrolled and received protocol therapy. Of these patients, 60 had data submission sufficient to determine response.|||Participants|||Count of Participants
2850198|NCT00077207|Secondary|Percentage Probability of Event-free Survival (EFS)|Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.|Six years|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||percent probability EFS||95% Confidence Interval|Number
2850199|NCT00077207|Secondary|Percent Probability of Progression-free Survival (PFS)|Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.|3 years|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||Percent probability PFS||95% Confidence Interval|Number
2850200|NCT00077207|Secondary|Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.|Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.|Up to 18 months of protocol therapy|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||Participants|||Count of Participants
2850201|NCT00077207|Secondary|Number of Participants Who Experienced Toxic Death|Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.|Up to 6 years after the start of protocol therapy|Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.|||Participants|||Count of Participants
2850202|NCT00077207|Primary|Long Term Feasibility Success|"Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.~If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success."|60 weeks|Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.|||participants|||Number
2850203|NCT00077207|Primary|Short Term Feasibility Success|"Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.~Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure."|24 weeks|Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.|||participants|||Number
2850204|NCT00077064|Secondary|Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment|Patients who experienced a Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation were assessed to determine if the toxicity persisted for 2 years.|2 years from completion of study treatment|Randomized patients who received study drug treatment and experienced lung toxicity at 1 year|||Participants|||Count of Participants
2850205|NCT00077064|Secondary|Correlation of Quality of Life With Late Effects as Measured by European Organization for Research and Treatment of Cancer (EORTC) C-30 or EORTC Lung Cancer Module (LC-13)|Only 2 patients have the required data- only 1.2% of the planned enrollment and 2.5% of the actual enrollment- which is extremely problematic as this data cannot be generalized, leads to selection bias, and is not representative of the patient population. Therefore the analysis was not conducted.|Baseline to 18 months post treatment|Eligible patients with late effect and baseline and 12-month EORTC data|||Participants|||Count of Participants
2850206|NCT00077064|Secondary|Correlation of Lung Toxicities With Biochemical Markers|Biomarker data will not be generated from these tissue specimens, therefore this analysis will not take place.|Once all patients have been followed for at least 12 months|||||||
2850207|NCT00077064|Primary|Incidence of Therapy-induced Lung Toxicity|Incidence of Grade 2+ radiation-induced pulmonary toxicity within 1 year after completion of radiation. Assuming that the incidence of pulmonary toxicity would be 50%, based on Fisher's exact test with a one-sided significance level of 0.05,168 randomized patients would be required to have 80% statistical power to detect a 40% relative reduction (from 50% to 30%) in the incidence of pulmonary toxicity while receiving captopril. Assuming that 15% of cases would not continue to the randomization stage and 5% of patients would be found ineligible, the target sample size was 205 patients. Given the actual sample size, power would be 25% and therefore p-values were not reported.|Once all patients have been followed for at least 12 months|Randomized eligible patients who started study drug treatment and were followed for one year after completion of radiation treatment or experienced radiation-induced pulmonary toxicity.|||percentage of participants||95% Confidence Interval|Number
2850208|NCT00076999|Primary|Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.|||participants|||Number
2850209|NCT00076999|Primary|Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.|||participants|||Number
2850210|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48||week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2850211|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24||week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2850212|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16||week 16|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2850213|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8||week 8|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2850214|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
2850215|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
2850216|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
2850217|NCT00076999|Secondary|Median Baseline CD4 Percent|Percentage of lymphocytes that are CD4 cells|baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||percentage of cells||Inter-Quartile Range|Median
2850218|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
2850219|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
2850220|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
2850221|NCT00076999|Secondary|Baseline Median CD4+ Cell Count (Cells/mm3)||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||cells/mm3||Inter-Quartile Range|Median
2850222|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
2850223|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||log10 copies/mL||Inter-Quartile Range|Median
2850234|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment|||participants|||Number
2850235|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Sentinel Immunized Node (SIN) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|Analysis of this outcome measure was performed on subjects in Stage I of the trial. Sentinel immunized nodes (SIN) were not evaluable for early tumor progression (5 arm 1, 2 arm 2) and patient refusal (1 arm 2). Thus, SINs were evaluable from 8 in arm 1 and 10 on arm 2, exceeding the protocol requirement for at least 6 subjects on each arm.|||responders|||Number
2850236|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Peripheral Blood Mononuclear Cells (PBMC) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm. Some patients were not evaluable because of inadequate sample availability.|||responders|||Number
2850237|NCT00003222|Primary|Evaluation of Objective Clinical Response (CR/PR/SD)|The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.|Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm.|||participants|||Number
2850238|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm||24 months||||cells/uL||Inter-Quartile Range|Median
2850239|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm||12 months||||cells/uL||Inter-Quartile Range|Median
2850240|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)|24 months||||participants|||Number
2850241|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat|at 12 and 24 months of treatment||||participants|||Number
2850242|NCT00076752|Secondary|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)|The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score <3 and prednisone <10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome.|Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||scores on a scale.||Standard Deviation|Mean
2850243|NCT00076752|Secondary|Natural Killer Cells|The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
2850244|NCT00076752|Secondary|Cluster of Differentiation 19 (CD19) + Cells|The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
2850245|NCT00076752|Secondary|Cluster of Differentiation 8 (CD8) + Cells|The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
2850246|NCT00076752|Secondary|Cluster of Differentiation 4 (CD4) + Cells|The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
2850247|NCT00076752|Secondary|Cluster of Differentiation 3 (CD3) + Cells|The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL.|Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.|One participant was enrolled but the study was closed before the patient could be treated.|||cells/mL^3||Standard Deviation|Mean
2850248|NCT00076752|Secondary|Platelet Count|The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
2851624|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 4||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2850249|NCT00076752|Secondary|Absolute Lymphocyte Count|The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
2850250|NCT00076752|Secondary|Absolute Neutrophil Count|The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
2850251|NCT00076752|Secondary|White Blood Cells|The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||K/uL||Standard Deviation|Mean
2850252|NCT00076752|Secondary|Anti-Smith-Ribonuclear Protein Antibody|Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.||||EU||Standard Deviation|Mean
2850253|NCT00076752|Secondary|Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody|Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||IU||Standard Deviation|Mean
2850254|NCT00076752|Secondary|Extractable Nuclear Antigen (ENA)|Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||EU||Standard Deviation|Mean
2850255|NCT00076752|Secondary|Anti-Nuclear Antibody|Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU.|Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.|One participant was enrolled but the study was closed before the patient could be treated.|||EU||Standard Deviation|Mean
2850256|NCT00076752|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|18 months||||participants|||Number
2850257|NCT00076752|Primary|Relapse-free Complete Clinical Response|Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later.|60 months|Ninth participant was taken off study before proceeding with transplant per principal investigator due to decision to put study on hold.|||Months||Full Range|Median
2850258|NCT00076622|Secondary|Cognitive Function (MMSE)|The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function. Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).|Measured at Month 12||||units on a scale||Standard Deviation|Mean
2850259|NCT00076622|Primary|Number of Falls Experienced by Participants Over Twelve Months of Surveillance||Measured from Baseline through Month Twelve||||number of falls|||Number
2850260|NCT00076622|Primary|Geriatric Depression Scale (GDS) Score|The GDS scale measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).|Measured at Month 12||||units on a scale||Standard Deviation|Mean
2850261|NCT00076570|Secondary|The Rate of Significant Drug-associated Complications.||3 years||||participants|||Number
2850262|NCT00076570|Primary|The Rate of Allograft Rejection||3 years||||participants|||Number
2850263|NCT00003298|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1|||years||90% Confidence Interval|Median
2850264|NCT00003298|Secondary|Overall Survival|Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1|||years||90% Confidence Interval|Median
2850265|NCT00003298|Primary|Grade 3 or Higher Toxicity Incidence on Step 1|Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.|assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)|eligible and treated patients on step 1|||percentage of participants||95% Confidence Interval|Number
2850266|NCT00003298|Secondary|Best Confirmed Response to Neoadjuvant Therapy|Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.|Assessed at surgery time (surgery performed during week 8-10 after registration to the study)|Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here.|||percentage of participants||95% Confidence Interval|Number
2850267|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score|Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).|Baseline and Week 104|"The analysis was done on the intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."|||Participants|||Number
2850268|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104|"Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. Worsening of CTP score was defined as a 2-point or greater increase from baseline, improvement in CTP score was defined as a 2-point or greater reduction from baseline, and stabilization of CTP score was defined as a change of 1-point or less from baseline."|From Baseline to weeks 52 and 104|"The analysis was done per intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."|||Participants|||Number
2850269|NCT00076336|Secondary|Duration of Initial Clinical Response|Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response - date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.|Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only patients who achieved clinical response were considered.|||Days||Standard Error|Mean
2850270|NCT00076336|Secondary|Time to Initial Clinical Response|Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.|From Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only the observed time to initial clinical response was summarized.|||Days||Standard Deviation|Mean
2850271|NCT00076336|Primary|Number of Participants With Clinical Response|Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.|From Baseline to Week 52|The analysis was on the intention-to-treat (ITT) population.|||Participants|||Number
2850272|NCT00076258|Primary|Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)|The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).|12 weeks||||percentage of participants in remission|||Number
2850273|NCT00076245|Primary|Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD)|Dichotomous Remission Status (remitted or not) at post-treatment|Post-treatment||||participants|||Number
2850274|NCT00076245|Primary|Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version|The Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.|Post-treatment||||units on a scale||Standard Deviation|Mean
2850275|NCT00076219|Primary|60-day All-cause Mortality|60-day all-cause mortality|60 days|Number of all-cause mortality by day 60|||participants|||Number
2850276|NCT00076102|Secondary|Number of Participants Who Contributed to the Tissue Bank|Tumor specimens from patients who undergo tumor surgery or biopsies for clinical reasons.|5 years|Participants declined to contribute specimens for the tissue bank.||||||
2850277|NCT00076102|Secondary|Number of Participants With A Response Evaluation Determined by the Comparison of Three-Dimensional (3D) Magnetic Resonance Imaging|Index lesions will be followed for progression by 3D magnetic resonance imaging. Compete response is a complete resolution of all measurable or palpable soft tissue tumors for ≥4 weeks and no appearance of new lesions. Partial response is a ≥50% reduction in the sum of the volume of all index lesions for ≥4 weeks. Progression is defined as a ≥20% increase in the volume of at least one of the index plexiform neurofibromas compared to the pretreatment volume measured prior to the start of treatment. Stable disease is a <20% increase, and <25% decrease in the sum of the volume of all index lesions for ≥4 weeks. Minor response is a ≥25% but <50% reduction in the sum of the volume of all index lesions for ≥4 weeks.|Prior to cycles 1, 4, 7, and 10 and then every 6 cycles thereafter, approximately 5 years|Five patients were not analyzed due to clinical progression (n=1), plexiform neurofibroma surgery (n=1), progression in a pre-existing brain tumor (n=1), and refusal of further therapy (n=2).|||Participants|||Count of Participants
2850278|NCT00076102|Secondary|Number of Participants With A Response Evaluation Determined by the Comparison of Two-Dimensional (2D) Magnetic Resonance Imaging|Index lesions will be followed for progression by 2D magnetic resonance imaging. Progression is defined as a ≥20% increase in the volume of at least one of the index plexiform neurofibromas compared to the pretreatment volume measured prior to the start of treatment.|Prior to cycles 1, 4, 7, and 10 and then every 6 cycles thereafter until progression|This outcome measure was not done because only 3D imaging was performed. Due to a detailed comparison of 1D-2D and 3D imaging for another study (Tipifarnib R115777) the investigator determined that a detailed comparison of 1D-2D and 3D analysis would really add no new knowledge. Therefore only 3D analysis was performed for this trial.||||||
2850279|NCT00076102|Secondary|Number of Participants With A Response Evaluation Determined by the Comparison of One-Dimensional (1D) Magnetic Resonance Imaging|Index lesions will be followed for progression by 1D magnetic resonance imaging. Progression is defined as a ≥20% increase in the volume of at least one of the index plexiform neurofibromas compared to the pretreatment volume measured prior to the start of treatment.|Prior to cycles 1, 4, 7, and 10 and then every 6 cycles thereafter until progression|This outcome measure was not done because only 3D imaging was performed. Due to a detailed comparison of 1D-2D and 3D imaging for another study (Tipifarnib R115777) the investigator determined that a detailed comparison of 1D-2D and 3D analysis would really add no new knowledge. Therefore only 3D analysis was performed for this trial.||||||
2850280|NCT00076102|Secondary|Longitudinal Total Quality of Life Scores Assessed by the Impact of Pediatric Illness Scale|"Quality of life was assessed by the Impact of Pediatric Illness scale for children 6-18 years of age. The child's primary caregiver completed the proxy Parent Form and children answered either the self-report Child or Adolescent (11-18 years) Form prior to cycles 1, 4, 7 and 10. The parallel IPI Scale forms assess four domains: adaptive behavior, emotional functioning, medical/physical status, and cognitive functioning. Responses to the 43 items are made on a 3-or5-point Likert scale (1 to 5 for Parent and Adolescent Form and 1, 3, 5 for the Child Form) ranging from not at all to a lot. Item scores are transformed to a scale of 0-100, and then mean scores are calculated for the four domains and total scale with higher scores indicating better QOL."|prior to cycles 1, 4, 7 and 10.|Of the 36 pts enrolled, 28 were within the age range of the IPI Scale at baseline. 2 pts did not have any QOL forms completed; 1 did not have a baseline & 6 pts had missing f/u evals. QOL data is presented for 19 pts. Due to pts not completing forms at random f/u evals, some time points have fewer than 19 pts included in the longitudinal analysis.|||scores on a scale||Standard Deviation|Mean
2850281|NCT00076102|Secondary|Quality of Life (QOL) Using the Impact of Pediatric Illness (IPI) Scale at Baseline|"Quality of life was assessed by the Impact of Pediatric Illness scale for children 6-18 years of age. The child's primary caregiver completed the proxy Parent Form and children answered either the self-report Child or Adolescent (11-18 years) Form. The parallel IPI Scale forms assess four domains: adaptive behavior, emotional functioning, medical/physical status, and cognitive functioning. Responses to the 43 items are made on a 3-or5-point Likert scale (1 to 5 for Parent and Adolescent Form and 1, 3, 5 for the Child Form) ranging from not at all to a lot. Item scores are transformed to a scale of 0-100, and then mean scores are calculated for the four domains and total scale with higher scores indicating better QOL. Baseline comparisons between child and parent total and domain scores were performed."|Baseline|Of the 36 patients enrolled, 28 were within the age range of the IPI Scale at baseline. Two patients did not have any QOL forms completed; one did not have a baseline evaluation, and six patients had missing follow-up evaluations. Thus, QOL data is presented for 19 subjects.|||Scores on a scale||Standard Deviation|Mean
2850282|NCT00076102|Primary|Percentage of Participants Who Had an Objective Response Rate|Objective response rate is defined as a complete response (CR) or partial response (PR). Complete response is a complete resolution of all measurable or palpable soft tissue tumors for ≥4 weeks and no appearance of new lesions. Partial response is a ≥50% reduction in the sum of the volume of all index lesions for ≥4 weeks.|≥4 weeks||||percentage of participants|||Number
2850283|NCT00076102|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years||||Participants|||Count of Participants
2850284|NCT00076102|Primary|Median Time to Disease Progression|Time to progression is defined as greater than or equal to 20% increase in plexiform neurofibromas (PN) volume on magnetic resonance imaging (MRI).|5 years||||Months||95% Confidence Interval|Median
2850285|NCT00076050|Secondary|Change in Vaginal Maturation Value|The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.|baseline and 2 years||||score||Standard Error|Mean
2850286|NCT00076050|Secondary|Changes in Women's Health Questionnaire Score|This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales ('yes definitely' to 'no, not at all'). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.|baseline and 2 years||||change in score||Standard Error|Mean
2850287|NCT00076050|Primary|Change From Baseline in Bone Mineral Density||baseline and 2 years||||g/cm2||Standard Deviation|Mean
2850288|NCT00076024|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks|||||||
2850309|NCT00075829|Secondary|Interval From First to Second Transplantation|Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.|Year 1|Patients that completed second transplant|||days||Full Range|Median
2850310|NCT00075829|Secondary|Cumulative Incidence of Treatment Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression.|Year 3|Patients that completed second transplant|||percentage of participants||95% Confidence Interval|Number
2850289|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Open-label)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|Subgroup of participants from the AT population with a confirmed objective tumor response (CR or PR).|||days||95% Confidence Interval|Median
2850290|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Double-blind)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||days||95% Confidence Interval|Median
2850291|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|All treated (AT) population included participants from Phase 2 who progressed by RECIST criteria while in the placebo + docetaxel treatment group and had a baseline disease assessment and received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2850292|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.|||percentage of participants||95% Confidence Interval|Number
2850293|NCT00076024|Primary|Time to Tumor Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.|||days||95% Confidence Interval|Median
2850294|NCT00076011|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks|||||||
2850295|NCT00076011|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
2850296|NCT00076011|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
2850297|NCT00076011|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).|||Days||95% Confidence Interval|Median
2850298|NCT00076011|Secondary|Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.|||Days||95% Confidence Interval|Median
2850299|NCT00076011|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.|||Percentage of participants||95% Confidence Interval|Number
2850300|NCT00075946|Secondary|Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization|The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.|Assessed at baseline and 6 months after randomization.|Patients with patient-reported outcomes (PRO) data available.|||units on a scale||Standard Deviation|Mean
2850301|NCT00075946|Secondary|Time to First Cytotoxic Therapy (TTFC)|TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.|Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.|Patients who were correctly randomized to one of the two maintenance arms.|||probability||95% Confidence Interval|Number
2850302|NCT00075946|Primary|Time to Rituximab Failure (TTRF)|TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression < 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).|Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.|Eligible patients who were randomized to one of the two arms for maintenance therapy.|||years||95% Confidence Interval|Median
2850303|NCT00075881|Secondary|1-year Progression Free Survival Probability|Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.|Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry|42 eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2850304|NCT00075881|Secondary|Response Rate on Reinduction|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days|7 eligible and treated patients were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
2850305|NCT00075881|Secondary|Response Rate on Maintenance|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days|15 eligible and treated patients were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
2850306|NCT00075881|Primary|Response Rate on Induction|Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days|42 eligible and treated patients were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
2850307|NCT00075829|Secondary|Incidences of Chronic GVHD|Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Years 1 and 2|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
2850308|NCT00075829|Secondary|Incidences of Graft Versus Host Disease (GVHD)|Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Day 100|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
2850311|NCT00075829|Secondary|Cumulative Incidence of Progression/Relapse|Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.|Year 3|Patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
2850312|NCT00075829|Secondary|Overall Survival (OS) for High Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Year 3|Patients that completed second transplant|||percentage of participants||95% Confidence Interval|Number
2850313|NCT00075829|Secondary|Overall Survival (OS) for Standard Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Years 1, 2, and 3|Patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
2850314|NCT00075829|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die or if they progress or relapse.|Year 3|Patients that completed second transplant|||percentage of patients||95% Confidence Interval|Number
2850315|NCT00075816|Secondary|Patient Quality of Life||Measured at baseline, 6 months, and 1, 2, and 5 years|No data collected||||||
2850316|NCT00075816|Secondary|Donor Quality of Life||Measured at 1, 6, and 12 months|No data collected||||||
2850317|NCT00075816|Secondary|Donor Recovery to Baseline Toxicity Scores||Measured at 1, 6, and 12 months|No data collected||||||
2850318|NCT00075816|Secondary|Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential||Measured at 1, 6, and 12 months|No data collected||||||
2850319|NCT00075816|Secondary|Immune Reconstitution||Measured at 100 days, 6 months, and 1 and 2 years|No data collected||||||
2850320|NCT00075816|Secondary|Current Immunosuppressive (IS) Free Survival|This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.|Measured at 2 years|No data collected.||||||
2850321|NCT00075816|Secondary|Acute GVHD Grade III-IV||100 days, 180 days||||percentage of patients||95% Confidence Interval|Number
2850322|NCT00075816|Secondary|Acute GVHD Grade II-IV||100 days, 180 days||||percentage of patients||95% Confidence Interval|Number
2850323|NCT00075816|Secondary|Grades III-V Unexpected Adverse Events||Measured by 2 years||||participants|||Number
2850324|NCT00075816|Secondary|Infections|Number of infection reports per patient.|Measured at 1 and 2 years|Analysis restricted to patients who received the transplant.|||participants|||Number
2850325|NCT00075816|Secondary|Relapse|Analysis restricted to patients who received the transplant.|Measured at 2 years||||percentage of patients||95% Confidence Interval|Number
2850326|NCT00075816|Secondary|Chronic GVHD||Measured at 2 years||||percentage of participants||95% Confidence Interval|Number
2850327|NCT00075816|Secondary|Extensive Chronic Graft-versus-host Disease (GVHD)||Measured at 730 days||||percentage of patients||95% Confidence Interval|Number
2850328|NCT00075816|Secondary|Graft Failure||Measured at 28 and 100 days||||percentage of patients||95% Confidence Interval|Number
2850329|NCT00075816|Secondary|Platelet Engraftment||Measured at Day 180||||percentage of patients||95% Confidence Interval|Number
2850330|NCT00075816|Secondary|Neutrophil Engraftment||Measured at Day 28||||percentage of patients|||Number
2850331|NCT00075816|Primary|Two-year Overall Survival|Overall survival rate at 2 years according to an intention-to-treat analysis.|Measured at 2 years||||percentage of patients||95% Confidence Interval|Number
2850332|NCT00075803|Secondary|Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days||1 year||||participants|||Number
2850333|NCT00075803|Secondary|Failure to Engraft||day 42||||participants|||Number
2850334|NCT00075803|Secondary|Time to Platelet Engraftment||180 days|||||||
2850335|NCT00075803|Secondary|Time to Neutrophil Engraftment||28 days|||||||
2850336|NCT00075803|Secondary|Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy|Although there were 82 Galactomannan (GM) positives, 4 were excluded due to piperacillin/tazobactam administration, without other documentation of IFI, and were deemed false positives.|1 year||||participants|||Number
2850337|NCT00075803|Secondary|Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)||100 and 365 days||||participants|||Number
2850338|NCT00075803|Secondary|Duration of Use of Amphotericin B or Caspofungin||180 days||||days||Inter-Quartile Range|Mean
2850339|NCT00075803|Secondary|Frequency of Use of Amphotericin B or Caspofungin||1 year||||percentage of patients||95% Confidence Interval|Number
2850340|NCT00075803|Secondary|Relapse Free Survival||100, 180, and 365 days||||percentage of patients||95% Confidence Interval|Number
2850341|NCT00075803|Secondary|Overall Survival||100, 180, and 365 days||||percentage of patients||95% Confidence Interval|Number
2850342|NCT00075803|Secondary|Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days||100, 180, and 365 days||||percentage of patients||95% Confidence Interval|Number
2850343|NCT00075803|Secondary|Frequency of Invasive Fungal Infections (IFI)|Incidence of proven, probably, or presumptive IFI|1 year||||percentage of patients||95% Confidence Interval|Number
2850344|NCT00075803|Primary|Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant||180 days|All randomized patients were included in the analysis|||percentage of patients||95% Confidence Interval|Number
2850345|NCT00075764|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)|Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2850346|NCT00075764|Secondary|Overall Survival|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.||||months||95% Confidence Interval|Median
2850347|NCT00075764|Secondary|Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable >= 24 weeks|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.||||percentage of participants|||Number
2850348|NCT00075764|Primary|Time to Tumor Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.|Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.||||months||95% Confidence Interval|Median
2850349|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).|Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.|||percentage of participants||95% Confidence Interval|Number
2850350|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.|5 years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."|||percentage of participants||95% Confidence Interval|Number
2850351|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Negative.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29||||participants|||Number
2850352|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Positive.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29||||participants|||Number
2850353|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).|Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.|5 years|"Patients on Arm/Group Prednisone and High Dose Methotrexate (non randomly assigned) are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up."|||percentage of participants||95% Confidence Interval|Number
2850354|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|5 Years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."|||percentage of participants||95% Confidence Interval|Number
2850355|NCT00075725|Primary|Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions|Event Free Probability.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.|||percentage of participants||95% Confidence Interval|Number
2850356|NCT00075608|Primary|Evaluate Immune Reconstitution|Evaluate immune reconstitution based on time to engraftment|3 months after treatment and annually|No data were collected or analyzed due to study termination||||||
2850357|NCT00075608|Primary|Response and Durability of Response|Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death|3 months after treatment and annually|No data were collected or analyzed due to study termination||||||
2850358|NCT00075608|Primary|Feasibility and Tolerability|Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events|3 months after treatment and annually|No data were collected or analyzed due to study termination||||||
2850359|NCT00075582|Secondary|Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose|The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.|From enrollment up to 20 weeks|Patients with Group III vaginal primary tumor|||Estimated percentage of participants|||Number
2850360|NCT00075582|Secondary|Percentage of Patients With Delayed Surgical Procedures|The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.|At 13 weeks after induction|All eligible Stage I Group III nonorbit primary and stage III group I/II patients|||percentage of participants||95% Confidence Interval|Number
2851588|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 48|Percentage of participants with Viral Load < 400 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2850361|NCT00075582|Secondary|Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy|The local failure rate will be estimated using cumulative incidence curves.|From enrollment up to 5 years|Patients who received reduced doses of radiation therapy.|||stimated percentage of participants||95% Confidence Interval|Number
2850362|NCT00075582|Primary|Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry|Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.|From enrollment up to 5 years|All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.|||Estimated percentage of participants||95% Confidence Interval|Number
2850363|NCT00075582|Primary|Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry|Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.|From enrollment up to 5 years|All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.|||Estimated percentage of participants||95% Confidence Interval|Number
2850364|NCT00075582|Primary|Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry|Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.|From enrollment up to 5 years|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.|||Estimated percentage of participants||95% Confidence Interval|Number
2850365|NCT00075504|Secondary|Overall Survival||Up to 2 years||||months||95% Confidence Interval|Median
2850366|NCT00075504|Secondary|Progression Free Survival|PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.|Up to 2 years||||months||95% Confidence Interval|Median
2850367|NCT00075504|Primary|Response Rate According to RECIST Criteria|Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.|Up to 2 years||||participants|||Number
2850368|NCT00075478|Secondary|Progression-free Survival|Percentage of patients with progression-free survival, estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
2850369|NCT00075478|Secondary|Incidence of Graft Rejection|Donor CD3 chimerism less than 5%|1 year after transplant||||participants|||Number
2850370|NCT00075478|Secondary|Incidence of Chronic Extensive GVHD|Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
2850371|NCT00075478|Secondary|Incidence of Grades II-IV Acute GVHD|Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods|120 days after transplant||||percentage of participants|||Number
2850372|NCT00075478|Secondary|Incidence of Relapse-related Mortality|Percentage of death following relapse/progression, estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
2850373|NCT00075478|Secondary|Incidence of Relapse/Progression|Percentage of relapse estimated by cumulative incidence methods|3 years after transplant||||percentage of participants|||Number
2850374|NCT00075478|Secondary|Incidence of Non-relapse Mortality|Percentage of NRM as estimated by cumulative incidence methods with competing risks|3 years after transplant||||percentage of participants|||Number
2850375|NCT00075478|Primary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|3 years after transplant||||percentage of participants|||Number
2850376|NCT00075400|Other Pre-specified|c-KIT Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by Immunohistochemistry (IHC)|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
2850377|NCT00075400|Other Pre-specified|p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
2850378|NCT00075400|Other Pre-specified|AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
2850379|NCT00075400|Other Pre-specified|PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline|||||||
2850380|NCT00075400|Secondary|Initial Histologic Grade|G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2850381|NCT00075400|Secondary|Initial Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients|||Participants|||Count of Participants
2850409|NCT00075218|Secondary|Change From Baseline in EQ-5D Health State Profile Index|Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)|||score on scale||Full Range|Median
2850382|NCT00075400|Secondary|Duration of Progression Free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years|Eligible and treated patients.|||months||Inter-Quartile Range|Median
2850383|NCT00075400|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact|From study entry to death or last contact, up to 5 years.|Eligible and treated patients|||months||95% Confidence Interval|Median
2850384|NCT00075400|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2850385|NCT00075400|Primary|Incidence of Adverse Effects as Assessed by CTCAE v 3.0|The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.|Each cycle during treatment and 30 days after treatment ends.|Eligible and treated patients|||Participants|||Count of Participants
2850386|NCT00075400|Primary|Progression-free Survival (PFS) > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2850387|NCT00075335|Primary|Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following Plerixafor Administration|Examine plerixafor mobilization effect on cytokine polarization of T-cells. Analyze cytokine gene expression profiles using a Th1-Th2-Th3 RT-PCR plate in CD3+ T cells collected form subjects mobilized with a single injection of plerixafor. 84 cytokine genes were analyzed for significant alteration in their profiles.|1 Day|Subjects who received plexirxafor 240mcg/kg. Data was collected 6 hours after injection.|||unique cytokine genes affected|||Number
2850388|NCT00075335|Primary|Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following G-CSF Administration|Examine G-CSF mobilization effect on cytokine polarization of T-cells. Analyze cytokine gene expression profiles using a Th1-Th2-Th3 RT-PCR plate in CD3+ T cells collected form subjects mobilized with 5 injections of G-CSF. 84 cytokine genes were analyzed for significant alteration in their profiles.|1 Day|8 Subjects received G-CSF for 5 days.|||unique cytokine genes affected|||Number
2850389|NCT00075270|Secondary|Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4|The severity of adverse events was graded per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3. Grades 1 through 5 have unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1, Mild AE; Grade 2, Moderate AE; Grade 3, Severe AE; Grade 4, Life-threatening or disabling AE; Grade 5, death related to AE.|Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)|Safety Population: all randomized participants who received at least one dose of investigational product (based on the actual treatment received if this differed from that to which the participant was randomized). Two participants randomized to the placebo group actually received lapatinib.|||participants|||Number
2850390|NCT00075270|Secondary|Serum ErbB2 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB2. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||ng/mL||Standard Deviation|Mean
2850391|NCT00075270|Secondary|Serum ErbB1 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB1. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2850392|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results|"The Press Laboratory tested participants who were 2+ (weak to moderate complete staining) or 3+ (strong complete staining) for ErbB2 overexpression by IHC for ErbB2 gene amplification using the FISH assay. The results of the FISH assay can be ErbB2 gene amplification (increased number of copies of the ErbB2 gene) or non-amplification (not many copies of the ErbB2 gene). A status of Assay not done was assigned to those participants with no available samples and to those with inconclusive results (e.g., due to hybridization or staining problems)."|Baseline|ITT Population|||participants|||Number
2850427|NCT00074984|Secondary|Neuropathic Pain as Assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire (Pain at Its Worst)|Neuropathic pain was assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire on a scale of 0 (no pain) to 10 (pain as bad as you can imagine)|at 24 months|Intent-to-treat population|||units on a scale||Standard Deviation|Mean
2850393|NCT00075270|Secondary|Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening|"The Press Laboratory tested tumor tissue samples (taken at Screening, prior to randomization to study treatment) to determine intra-tumoral expression levels of ErbB1, ErbB2, and other analytes associated with these pathways by IHC, the process of detecting antigens (e.g., proteins) in cells of a tissue section. The IHC assessment is expressed as: 0, no staining (no cancer cells); 1+, faint staining; 2+, weak to moderate complete staining; 3+, strong complete staining (many cancer cells). A status of Assay not done was assigned to participants with no available samples and to those with inconclusive results. If strong staining is observed, breast cancer that has high levels of HER2 expression (overexpression) is indicated. If moderate/weak staining is observed (IHC=2+), breast cancer that has low/moderate expression levels is indicated. When no staining is observed (IHC=0), breast cancer HER2 expression may be below the level of detection of the assay."|Screening (Day -1)|ITT Population|||participants|||Number
2850394|NCT00075270|Secondary|ErbB2 Ratio|The Press Laboratory collected tumor tissues of participants for biomarker testing. All samples were analyzed by the Press Laboratory. The ratio of ErbB2 gene signals to chromosome 17 signals, which indicates the progression of breast cancer, was calculated. Low levels of amplification (few copies) may have a ratio of 2-5, whereas high levels of amplification may have a ratio >10.|Baseline|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||ratio of signals||Standard Deviation|Mean
2850395|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Status at Baseline|The Press Laboratory collected tumor tissues of participants for ErbB2 testing. ErbB2 testing is done to detect breast cancer and predict its likely outcome. All samples were analyzed by the Press Laboratory. Participants were categorized as ErbB2 positive (overexpression of the ErbB2 gene), ErbB2 negative, and assay not done (which included participants with no available samples and those with inconclusive results). ErbB2 status is determined by immunohistochemistry (ICH) assay and fluorescence in situ hybridization (FISH) testing. Negative ErbB2 status is defined as 0 or 1+ by IHC, or as 2+ by IHC and FISH.|Baseline|ITT Population|||participants|||Number
2850396|NCT00075270|Secondary|Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores|The TOI questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, functional well-being, and additional cancer concerns. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each question scored from 0 [not at all] to 4 [very much]); the breast cancer unweighted subscale scores range from 0 to 36, based on 9 questions. The total TOI score (ranging from 0 [better QOL] to 92 [worse QOL]) is the sum of the TOI subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||Scores on a scale||Standard Deviation|Mean
2850397|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|The FACT-G questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, social/family, emotional, and functional well-being. The physical, social/family, and functional well-being subscale scores range from 0 to 28, based on responses to 7 questions (each question scored from 0 [not at all] to 4 [very much]); the emotional well-being subscale score ranges from 0 to 24, based on responses to 6 questions. The FACT-G Total Score (ranging from 0 [better QOL] to 108 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.|||Scores on a scale||Standard Deviation|Mean
2850398|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores|The FACT-B questionnaire was designed to measure multidimensional quality of life (QOL) in participants with breast cancer. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each scored from 0 [not at all] to 4 [very much] for all subscales); the emotional and social/family well-being (1 question optional) subscale scores range from 0 to 24 (based on 6 questions), and the additional concerns subscale score ranges from 0 to 40, based on 10 questions. The FACT-B Total Score (0 [better QOL] to 144 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.|||Scores on a scale||Standard Deviation|Mean
2850399|NCT00075270|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization until the date of death due to any cause (average of 24 months)|ITT population. Overall survival was assessed in participants who died as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those still alive), the date of the last contact was used.|||months||95% Confidence Interval|Median
2850400|NCT00075270|Secondary|Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||participants|||Number
2850840|NCT00069576|Secondary|Number of Participants Who Underwent Labor Induction|Number of participants who underwent labor induction|From time of randomization through induction (up to 17 weeks)|Data was missing for 9 women in the treatment group and 18 women in the control group.|||Participants|||Count of Participants
2850401|NCT00075270|Secondary|Progression-Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progression disease (PD) or death due to any cause, if sooner. For TLs, progressive disease is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. par., participants.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population. PFS was assessed in par. who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored par. (those without a documented date of disease progression/death due to any cause), the date of the last radiographic assessment was used.|||weeks||95% Confidence Interval|Median
2850402|NCT00075270|Secondary|Duration of Response (DOR)|The investigator evaluated the DOR for the subset of participants who showed a CR (disappearance of all TLs and NTLs) or PR (TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion). DOR is defined as the time from the first documented evidence of PR or CR until the first documented sign of PD (TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion; NTL: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs) or death due to breast cancer, if sooner.|From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)|ITT Population. Only participants who had a CR or PR were evaluated.|||weeks||Inter-Quartile Range|Median
2850403|NCT00075270|Secondary|Number of Participants With a Response of CR or PR by the Indicated Study Week|Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR (disappearance of all TLs and NTLs) or PR (for TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; for NTLs: the persistence of >=1 lesion) (whichever status was recorded first). TTR data are displayed as the number of participants achieving a CR or PR by the indicated week. The investigator evaluated the TTR, and the analysis was based on responses confirmed at a repeat assessment, with the TTR taken as the first time the response was observed.|Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72|ITT Population|||participants|||Number
2850404|NCT00075270|Secondary|Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator|Percentage of participants. with CB is defined as the percentage of participants with evidence of CR (disappearance of all TLs and NTLs), PR (TLs: a >=30% decrease in the sum of the LD, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion), or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for >=6 months based on RECIST criteria. PD for TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion. PD for NTLs: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||Percentage of participants|||Number
2850405|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Independent Review Committee|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The RECIST criteria was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||participants|||Number
2850406|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Investigator|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The Response Evaluation Criteria in Solid Tumors (RECIST) was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||participants|||Number
2850407|NCT00075270|Primary|Time to Progression as Evaluated by the Independent Review Committee (IRC)|Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population|||weeks||Inter-Quartile Range|Median
2850408|NCT00075270|Primary|Time to Progression as Evaluated by the Investigator|Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who had received at least one dose of randomized therapy (lapatinib or placebo)|||weeks||Inter-Quartile Range|Median
2850410|NCT00075218|Secondary|Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)|"Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated thermometer, indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state."|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)|||score on scale||Full Range|Median
2850411|NCT00075218|Secondary|Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population.|||participants|||Number
2850412|NCT00075218|Secondary|Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.|||weeks (25th Quartile)||95% Confidence Interval|Median
2850413|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)|From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.|||weeks||95% Confidence Interval|Median
2850414|NCT00075218|Secondary|Duration of Performance Status Maintenance|Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.|Day 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.|||weeks||95% Confidence Interval|Median
2850415|NCT00075218|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population. Number of subjects analyzed = number of subjects with tumor response.|||weeks||95% Confidence Interval|Median
2850416|NCT00075218|Secondary|Confirmed Objective Response (CR or PR) in Subjects|Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population.|||participants|||Number
2850417|NCT00075218|Secondary|Best Overall Tumor Response During Double-blind Treatment Phase|Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population|||participants|||Number
2850418|NCT00075218|Secondary|Overall Survival Based on the Rank Preserving Structural Failure Time Method|time from date of randomization to date of death due to any cause (rank preserving structural failure time method).|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population|||weeks||95% Confidence Interval|Median
2850419|NCT00075218|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.|||weeks||95% Confidence Interval|Median
2850420|NCT00075218|Secondary|Overall Survival Status of Subjects|Number of subjects alive at end of study.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population.|||participants|||Number
2850421|NCT00075218|Secondary|Progression Free Survival (PFS)|Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population|||weeks||95% Confidence Interval|Median
2850422|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase|From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.|||weeks||95% Confidence Interval|Median
2850423|NCT00075088|Secondary|Rehospitalization and Mortality||4 years|we did not have the resources to achieve this secondary aim that required long-term follow up (a labor intensive job). The PI is now retired.||||||
2850424|NCT00075088|Primary|Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)|Mean door-to-balloon time|Day 1|42 patients with STEMI who received primary percutaneous coronary intervention|||minutes||Standard Deviation|Mean
2850425|NCT00075088|Primary|Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI|Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI|Day 1|Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis|||minutes||Standard Deviation|Mean
2850426|NCT00075023|Primary|Mean Percentage Change in Total Surface Area of Oral Ulceration.|Mean percentage change in total surface area of oral ulceration|baseline to 4 weeks||||percentage change||Standard Deviation|Mean
2850428|NCT00074984|Secondary|Slope of Inverse Serum Creatinine Values Comparing Placebo vs Fabrazyme (Agalsidase Beta)Patients|Summary of slopes of inverse serum creatinine by baseline serum creatinine subgroups (> or <= 1.5 mg/dL) comparing Placebo vs Fabrazyme (agalsidase beta) patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.|||dL/mg/year||Standard Deviation|Mean
2850429|NCT00074984|Secondary|Slope of Estimated Glomerular Filtration Rate (eGFR) Comparing Placebo vs Fabrazyme (Agalsidase Beta) Patients|Summary of slopes of eGFR by baseline eGFR subgroups (>60 and <=60 mL/min/1.73m^2/year) comparing Placebo vs Fabrazyme (agalsidase beta) Patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication|||mL/min/1.73m^2/year||Standard Deviation|Mean
2850430|NCT00074984|Secondary|Number of Participants Experiencing a Renal Event in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|Time to a clinically significant renal event (33% increase in serum creatinine, dialysis or transplant) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.|||participants|||Number
2850431|NCT00074984|Primary|Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|The primary efficacy endpoint was the time to the first occurrence of a clinically significant renal (33% increase in serum creatinine, dialysis or transplant), cardiac (myocardial infarction, significant change in cardiac status, i.e., angina, congestive heart failure or symptomatic arrhythmia requiring medication or surgery) or cerebrovascular (stroke or transient ischemic attack) event and/or death (due to any cause) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat (ITT) population consists of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.|||participants|||Number
2850432|NCT00074958|Secondary|Plasma GL-3|Plasma GL-3 values at Baseline, Week 24, and Week 48. Normal plasma GL-3 level is ≤ 7.03 µg/mL.|Baseline, Week 24 and Week 48|ITT population. 16 male patients had plasma GL-3 values at Baseline and Week 24, while 15 male patients had plasma GL-3 values at Week 48. 2 female patients had plasma GL-3 values at Baseline, Week 24 and Week 48.|||µg/mL||Standard Deviation|Mean
2850433|NCT00074958|Primary|Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin|Skin biopsies were taken at Baseline, Week 24 and Week 48 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Baseline, Week 24 and Week 48|Intent to Treat (ITT) population – male patients only. 14 patients had skin biopsies performed at Baseline and Week 24 but only 5 patients had skin biopsies performed at Week 48.|||patients|||Number
2850434|NCT00074815|Secondary|Pediatric Adverse Event Rating Scale (PAERS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up|||||||
2850435|NCT00074815|Secondary|Child Depression Inventory||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up|||||||
2850436|NCT00074815|Secondary|Child Obsessive -Compulsive Impact Scale (COIS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up|||||||
2850437|NCT00074815|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|"OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).~Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure."|Measured at baseline and Week 12.|Intent to treat (all included)|||Proportion of Participants with RESPONSE||95% Confidence Interval|Number
2850438|NCT00074802|Secondary|Quality of Life Inventory (QOLI)|The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
2850439|NCT00074802|Secondary|Liebowitz Self-Report Disability Scale (LSRDS)|The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
2850440|NCT00074802|Secondary|Brief Fear of Negative Evaluation Scale (BFNE)|The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
2850441|NCT00074802|Secondary|Social Phobia Scale (SPS)|The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
2850442|NCT00074802|Secondary|Social Interaction Anxiety Scale (SIAS)|The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
2850443|NCT00074802|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.|Responder and remitter status measured at Week 28|Responders (CGI-I=1 or 2). Remitters (CGI-I=1). Analyses based on Week 28 observations if available. if not, Week 20 or Week 12 observations were substituted. Fisher's Exact Test used for analyses.|||Participants|||Count of Participants
2850444|NCT00074802|Primary|Liebowitz Social Anxiety Scale (LSAS)|The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.|Change measured from Week 12 to Week 28|Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations.|||units on a scale||Standard Deviation|Mean
2850445|NCT00074711|Secondary|Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months||Measured at baseline and 12 months||||micromol/mmol||Standard Error|Mean
2850446|NCT00074711|Secondary|Change From Baseline in Urinary N-telopeptide at 12 Months||Measured at baseline and 12 months||||nmol bce/mmol||Standard Error|Mean
2850447|NCT00074711|Secondary|Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months||Measured at baseline and 12 months||||g/g||Standard Error|Mean
2850448|NCT00074711|Secondary|Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months||Measured at baseline and 12 months||||mg/dl||Standard Error|Mean
2850449|NCT00074711|Primary|Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).|The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).|12 months|Participants that completed study.|||g/cm2||Standard Error|Mean
2850450|NCT00074711|Primary|Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.|Bone mineral density (BMD, measured by dual X-ray absorptiometry - DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).|Measured at Baseline|Postmenopausal women with spinal osteoporosis.|||g/cm2||Standard Deviation|Mean
2850451|NCT00074581|Primary|All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.|Throughout study|Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm.|||event rate per 100 person-yr||95% Confidence Interval|Number
2850452|NCT00074581|Primary|Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.|Throughout study||||event rate per 100 person-yr|Person Years|95% Confidence Interval|Number
2850453|NCT00074490|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 5 years||||Participants|||Count of Participants
2850454|NCT00074490|Secondary|Percentage of Patients With Opportunistic Infection|Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease.|First 100 days post-transplant||||percentage of participants|||Number
2850833|NCT00069576|Secondary|Number of Children With BMI ≥ 85th Percentile for Age and Sex|Number of children with BMI ≥ 85th percentile for age and sex at the 5-10 year follow-up. BMI is measured as kg/m^2. Standards base on the 2000 Centers for Disease Control growth charts.|Age 5-10 years||||Participants|||Count of Participants
2850455|NCT00074490|Secondary|Detection of of Post-transplantation Cluster of Differentiation 4 (CD4)+ and CD8+ T-cell Production of T Helper 1 -2 (Th1-Th2)-Type Cytokines|Detection of cytokine secretion was done by enzyme-linked immunosorbent assay.|First 100 days post-transplant|This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of study.||||||
2850456|NCT00074490|Primary|Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)|GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1.|first 100 days post-transplant||||percentage of patients|||Number
2850457|NCT00074490|Primary|Percentage of Patients to Receive T Cell Infusion|T cells administered by intravenous infusion after patient received transplant.|first 100 days post-transplant||||percentage of patients|||Number
2850458|NCT00074412|Secondary|NVP Concentrations in Infants Determined to be HIV-infected and in a Sample of HIV-uninfected Infants|Samples for NVP concentration were selected from the Version 3.0 infants who were randomized to NVP at 6 weeks and whose mothers were not on 3 or more antiretrovirals at the time of randomization. All infants HIV-infected by 6 months who met this criteria were selected and matched to HIV-uninfected infants who also met this criteria in a 1:3 ratio. NVP concentrations were measured by high liquid chromatographic/mass spectroscopy from the aforementioned infants plasma samples collected at week 8 and month 3. Median NVP concentrations were compared|Week 8 and Month 3|||||||
2850459|NCT00074412|Secondary|Rates of Disease Progression as Defined by CD4 Counts, HIV-1 RNA PCR, and Mortality in Infected Infants in the Two Arms||Throughout study|||||||
2850460|NCT00074412|Secondary|Frequency and Duration of NVP-resistant HIV Strains in Plasma of HIV-infected Infants||Throughout study|||||||
2850461|NCT00074412|Secondary|Relationship Between Maternal Plasma and Breast Milk RNA Levels and the Risk of MTCT||Throughout study|||||||
2850462|NCT00074412|Secondary|Frequency and Duration of Maternal Plasma and Breast Milk NVP-resistant HIV Strains and the Relationship With HIV Transmission||Throughout study|||||||
2850463|NCT00074412|Secondary|Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms||At Month 18||||participants|||Number
2850464|NCT00074412|Secondary|Relative Rates of HIV Infection in the Two Arms||At Month 18|A total of 1527 infants were randomized to either placebo or extended NVP. 5 of these infants were later found to be infected at the time of randomization (2 in NVP and 3 in Placebo). Thus, only 1522 infants were included in the analysis.|||participants|||Number
2850465|NCT00074412|Secondary|Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms||At Months 6 and 18|There were 1522 infants randomized at 6 weeks of birth to either the extended Nevirapine arm (759) or the placebo arm (763).|||participants|||Number
2850466|NCT00074412|Primary|Frequency and Severity of Adverse Reactions Among Participating Infants|For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness.|6 weeks through 18 months|A total of 1519 infants, 758 in the NVP arm and 761 in the placebo arm, initiated study product and were thus included in the analysis for the frequency and severity of adverse reactions.|||Number of Adverse Events|Participants||Number
2850467|NCT00074412|Primary|HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study||At Month 6|All infants who were randomly allocated to either treatment or placebo at 6 weeks of age under version 3.0 of the protocol were included in the analysis of the primary endpoint, HIV infection at 6 months. 127/1700 infants were enrolled but excluded from randomization at 6 weeks for various reasons as mentioned in the flow-through.|||participants|||Number
2850468|NCT00074308|Secondary|Overall Survival (Phase II)|Kaplan-Meier estimates of overall survival and 95% confidence intervals will be calculated.|Up to 6 years|Data not collected||||||
2850469|NCT00074308|Secondary|Response Rate at 8 Weeks, Evaluated Using RECIST (Phase II)|"Response and progression was evaluated in this study using Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|8 weeks||||Participants|||Count of Participants
2850470|NCT00074308|Primary|Progression-free Survival at 16 Weeks (Phase II)|Progression Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|16 weeks||||Participants|||Count of Participants
2850471|NCT00074308|Primary|MTD, Defined as One Dose Level Below the Dose That Induced DLT in at Least One Third of Patients at a Dose Level, Graded According to NCI CTCAE Version 3.0 (Phase I)||Up to 28 days||||dose level|||Number
2850472|NCT00074282|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from registration until induction failure, institution of non-protocol therapy, relapse or death from any cause in the absence of relapse.|Up to 5 years from registration|Eligible patients who began treatment|||months||90% Confidence Interval|Median
2850473|NCT00074282|Secondary|Overall Survival (OS)|OS is defined as the time from registration until death from any cause.|Up to 5 years from registration|Eligible patients who began treatment|||months||90% Confidence Interval|Median
2850474|NCT00074282|Primary|Molecular Complete Remission (MCR) Rate|Proportion of patients who have MCR (clinical CR with flow negative and RT-PCR negative)|3 months post alemtuzumab|Patients who achieved a CR or nPR in Step 1 and were eligible for and began treatment on Step 2|||Participants|||Count of Participants
2850475|NCT00074282|Primary|Response Rate|Proportion with response (CR, nPR, PR)|8 weeks after Cycle 6|Eligible patients who began treatment|||Participants|||Count of Participants
2850476|NCT00074269|Secondary|Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting||1 month post allografting|study was closed early due to lack of accrual.|||Participants|||Count of Participants
2851589|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 40|Percentage of participants with Viral Load < 400 copies/mL|Week 40||||Percentage of participants|||Number
2850477|NCT00074269|Secondary|Response (Partial and Complete) as Measured at 12 Months Post Allografting|response assessed by CT scan|From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months|study was closed early due to lack of accrual.|||Participants|||Count of Participants
2850478|NCT00074269|Secondary|Overall Survival||1 year from the time of transplant|study was closed early due to lack of accrual.|||days||Full Range|Median
2850479|NCT00074269|Secondary|Progression-free Survival|Progression assessed by CT scan|From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months|study was closed early due to lack of accrual.|||days||Full Range|Median
2850480|NCT00074269|Primary|Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)||100 days post transplant|study was closed early due to lack of accrual.|||Participants|||Count of Participants
2850481|NCT00074269|Primary|Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes|based on cell counts of ANC >1000 for 3 consecutive days and platelet count of >50,000|30 days post transplant|study was closed early due to lack of accrual.|||Participants|||Count of Participants
2850482|NCT00074269|Primary|Number of Participants With Adverse Events||5 years post transplant|study was closed early due to lack of accrual.|||Participants|||Count of Participants
2850483|NCT00074165|Secondary|Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment||2 years|||||||
2850484|NCT00074165|Secondary|Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment||2 years|||||||
2850485|NCT00074165|Secondary|Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months||5 years|||||||
2850486|NCT00074165|Secondary|Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression||5 years|||||||
2850487|NCT00074165|Secondary|Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response|Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.|5 years|Inadequate sample size to determine overall survival||||||
2850488|NCT00074165|Primary|Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.|Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.|2 years||||Participants|||Number
2850489|NCT00074152|Secondary|Sites of First Failures|Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow|5 years after randomization||||participants|||Number
2850490|NCT00074152|Secondary|Overall Survival||5 years after randomization||||percentage of participants||95% Confidence Interval|Number
2850491|NCT00074152|Primary|Disease-free Survival||5 years after randomization||||percentage of participants||95% Confidence Interval|Number
2850492|NCT00074035|Secondary|Pharmacokinetics||At initiation of Tx and at 3 months|||||||
2850493|NCT00074035|Secondary|Overall Survival At 2 Years|Percentage of patients who were alive at 2 years.|2 year||||percentage of participants|||Number
2850494|NCT00074035|Secondary|Overall Survival At 1 Year|Percentage of patients who were alive at 1 year.|1 year||||percentage of participants|||Number
2850495|NCT00074035|Secondary|Grade 3 or Higher Non-hematologic Adverse Events|Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.|Duration of treatment (up to 5 years)||||count of participants|||Number
2850496|NCT00074035|Primary|Response Rate|"Percentage of participants who had a complete or partial response defined by the Hopkins scoring system.~A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others."|3 months|3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint|||percentage of participants|||Number
2850497|NCT00073983|Secondary|Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study|Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.|Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.|There were insufficent samples obtained to analyze pharmacokinetics.|||participants|||Number
2850498|NCT00073983|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.|Throughout the study|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.|||participants|||Number
2850499|NCT00073983|Secondary|Time to Progression|Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.|post-cycle 2, 4, 8 and 12|Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.|||months|||Number
2850834|NCT00069576|Secondary|Mean Maternal Weight Gain|Mean Maternal weight gain from enrollment in the trial until delivery|From time of randomization through delivery (up to 17 weeks)|Data was missing for 9 women in the treatment group and 18 women in the control group.|||kilograms||Standard Deviation|Mean
2850500|NCT00073983|Primary|Objective Response Rate|Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.|After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.|||participants|||Number
2850501|NCT00073957|Secondary|Event Free Survival|the median time point at which a participants experienced and event or toxicity or progression|12 months||||months||Full Range|Median
2850502|NCT00073957|Primary|Best Response|This data is the best overall response achieved by patients by the 12 month period.|12 months||||Participants|||Count of Participants
2850503|NCT00073957|Primary|Response Rate = Complete and Partial Response at 12 Weeks.|Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node > 1 cm in short axis > 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy|12 weeks||||participants|||Number
2850504|NCT00073918|Secondary|Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0|Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%|From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years|Number of Grade 3-4 toxicities.|||events|||Number
2850505|NCT00073918|Secondary|Response Rate|Response rates will be estimated as the percentage of patients|From date of transplant through date of relapse/progression or death, assessed up to 15 years|Percentage of patients|||percentage of participants|||Number
2850506|NCT00073918|Secondary|5 Year Overall Survival|Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.|Up to 15 years||||percentage of participants|||Number
2850507|NCT00073918|Primary|Progression-free Survival|Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.|At year 3||||percentage of participants|||Number
2850508|NCT00073749|Other Pre-specified|Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)|Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.|Baseline up to 42 days after last dose of study drug (Day 225)|ITT population included all enrolled participants. Here ‘N’ signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||percentage of particpants||95% Confidence Interval|Number
2850509|NCT00073749|Other Pre-specified|Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)|Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.|Baseline up to 42 days after last dose (Day 225)|Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study.|||percentage of participants||95% Confidence Interval|Number
2850510|NCT00073749|Secondary|Time-to-Tumor Progression: Part 2 (Expanded Cohorts)|Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|"Evaluable population was analyzed. Here N signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort) of the study."|||days||95% Confidence Interval|Median
2850511|NCT00073749|Secondary|Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)|Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Evaluable population was analyzed. DoR included evaluable participants who achieved CR, CRu, or PR. Here ‘N’ signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||days||95% Confidence Interval|Median
2850512|NCT00073749|Secondary|Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)|Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Evaluable population was analyzed. Participants with diffuse or follicular lymphoma were analyzed. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort).|||participants|||Number
2850513|NCT00073749|Secondary|Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)|Interval OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline up to Year 5|ITT population included all enrolled participants. Here ‘N’ signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||days||95% Confidence Interval|Median
2850514|NCT00073749|Secondary|Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)|OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline up to Year 5|Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study.|||days||95% Confidence Interval|Median
2850515|NCT00073749|Secondary|Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)|PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Intent-to-treat (ITT) population included all enrolled participants. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.|||days||95% Confidence Interval|Median
2850516|NCT00073749|Secondary|Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)|PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor computed tomography (CT) scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This was not planned to be analyzed in Part 1 of study.|||days||95% Confidence Interval|Median
2850517|NCT00073749|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.|Baseline up to Day 28|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. Here number of participant analyzed (N) signifies participants evaluable for this outcome measure.|||participants|||Number
2850528|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data|The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.|||scores on a scale||Standard Error|Mean
2850518|NCT00073749|Primary|Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.|Baseline up to Day 28|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. This outcome measure was not planned to be analyzed in Part 2 of the study.|||milligram per meter square (mg/m^2)|||Number
2850519|NCT00073749|Primary|Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported.|Baseline up to 42 days after last dose of study drug (up to Day 225)|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin.|||participants|||Number
2850520|NCT00073749|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).|Baseline up to 42 days after last dose of study drug (up to Day 225)|Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin.|||participants|||Number
2850521|NCT00073528|Secondary|Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline|EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).|Baseline|ITT Population|||participants|||Number
2850522|NCT00073528|Secondary|Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive|Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions.|Up to 46 months|HER2-Negative Population. Only those participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL were assessed.|||weeks||95% Confidence Interval|Median
2850523|NCT00073528|Secondary|Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive|Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion.|Up to 46 months|HER2-Negative Population: all randomized participants regardless of whether or not study treatment had been received and who at baseline were evaluated by the central laboratory to have retrospectively documented non-amplification or missing amplification of HER2 by FISH (<2.0) and documented IHC scores of 0, 1+, 2+, or missing in tumor tissue.|||participants|||Number
2850524|NCT00073528|Secondary|Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower|The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.|Up to 46 months|HER2-Positive Population|||participants|||Number
2850525|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity|IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period.|Up to 46 months|ITT Population|||participants|||Number
2850526|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status|Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.|Up to 46 months|ITT Population|||participants|||Number
2850527|NCT00073528|Secondary|Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores|A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores.|Up to 46 months|HER2-Positive Population. Only those participants with a baseline score and at least one post-baseline score were assessed.|||participants|||Number
2850835|NCT00069576|Secondary|Mean Maternal Body-mass Index at Delivery|Mean maternal body-mass index at the time of delivery|Delivery|Data was missing for 9 women in the treatment group and 18 women in the control group.|||kg/m^2||Standard Deviation|Mean
2850529|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data|FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.|||scores on a scale||Standard Error|Mean
2850530|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.|||scores on a scale||Standard Error|Mean
2850531|NCT00073528|Secondary|Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.|Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit|ITT Population|||participants|||Number
2850532|NCT00073528|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAEs) Related to Study Drug Reported by More Than One Participant in Either Treatment Arm|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Up to 46 months|Safety Population. Only those participants who experienced SAEs related to study drug that were reported by more than one participant in either treatment arm were assessed.|||participants|||Number
2850533|NCT00073528|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Related to Study Treatment Reported in 10% or More Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study treatment.|Up to 46 months|Safety Population: all randomized participants who had received at least 1 dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. All participants with any AE related to study treatment were assessed.|||participants|||Number
2850534|NCT00073528|Secondary|TTP for Participants From the ITT Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|ITT Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.|||weeks||95% Confidence Interval|Median
2850535|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases From the ITT Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|ITT Population|||participants|||Number
2850536|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR response were assessed.|||weeks||Inter-Quartile Range|Median
2850537|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR were assessed.|||participants|||Number
2850538|NCT00073528|Secondary|Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|ITT Population|||percentage of participants|||Number
2850836|NCT00069576|Secondary|Number of Participants Who Had Preeclampsia or Gestational Hypertension|Number of participants who had Preeclampsia or gestational hypertension|From time of randomization through delivery (up to 17 weeks)|Data was missing for 9 women in the treatment group and 18 women in the control group.|||Participants|||Count of Participants
2850539|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.|Up to 46 months|ITT Population. Only those participants with some measurable disease were assessed. Response with bone scan confirmation was required. Participants with bone-only disease were excluded from the analysis because bone-only disease is non-measurable only per RECIST 1.0.|||participants|||Number
2850540|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|ITT Population. Only those participants who achieved either a confirmed CR or PR were assessed.|||percentage of participants|||Number
2850541|NCT00073528|Secondary|Overall Survival in the ITT Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|ITT Population. Only those participants who died during the study due to any cause were assessed.|||weeks||95% Confidence Interval|Median
2850542|NCT00073528|Secondary|Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.|||weeks||95% Confidence Interval|Median
2850543|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|HER2-Positive Population|||participants|||Number
2850544|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.|||weeks||Inter-Quartile Range|Median
2850545|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.|||participants|||Number
2850546|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|ITT Population|||participants|||Number
2850547|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|HER2-Positive Population|||participants|||Number
2850548|NCT00073528|Secondary|Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|HER2-Positive Population|||percentage of participants|||Number
2850573|NCT00073021|Secondary|Percentage of Treatment Success Patients at Week 3, ITT Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|3 Weeks|ITT Patients with Moderate Disease [PGA = 2] at Baseline|||Percentage of Participants|||Number
2850549|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.|Up to 46 months|HER2-Positive Population. Only those participants with measurable disease, including bone scans, were assessed.|||participants|||Number
2850550|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|HER2-Positive Population|||percentage of participants|||Number
2850551|NCT00073528|Secondary|Overall Survival in the HER2-Positive Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|HER2-Positive Population. Only those participants who died during the study due to any cause were assessed.|||weeks||95% Confidence Interval|Median
2850552|NCT00073528|Secondary|PFS in Participants in the ITT Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.|||weeks||95% Confidence Interval|Median
2850553|NCT00073528|Secondary|Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population: all randomized participants, regardless of whether or not study treatment had been received. The ITT Population included the HER2-Positive Population, the HER2-Negative Population, and the HER2-Missing Population.|||participants|||Number
2850554|NCT00073528|Primary|Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.|||weeks||95% Confidence Interval|Median
2850555|NCT00073528|Primary|Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Her3 as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months|HER2-Positive Population: all randomized participants who had documented amplification of baseline HER2 by fluorescence in situ hybridization (FISH) (=>2.0) or 3+ immunohistochemistry (IHC) (or 2+ IHC and FISH +) in archived tumor tissue regardless of whether or not study treatment had been received.|||participants|||Number
2850556|NCT00073333|Primary|Social Phobia Remission Rate at 6 Month Follow-up|Lack of SocialPhobia Diagnosis at 6 month follow-up|6 month follow up||||participants|||Number
2850557|NCT00073333|Secondary|Score on the SPAI||Measured at Month 12|||||||
2850558|NCT00073333|Primary|Social Phobia Remission||Measured at Month 12|||||||
2850586|NCT00073008|Secondary|Overall Survival|Overall survival is measured as the time from randomization until death due to any cause. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, overall survival was not analyzed.|From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death|||||||
2850559|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment|"Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from 0=not at all to 4=very much and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2850560|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment|"Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from 0=not at all to 4=very much and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.|||Scores on a scale||Standard Error|Least Squares Mean
2850561|NCT00073307|Secondary|Best Overall Response - Independent Radiological Review|Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.|||percentage of participants|||Number
2850562|NCT00073307|Secondary|Final Progression-Free Survival (PFS) - Independent Radiological Review|PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.|||days||95% Confidence Interval|Median
2850563|NCT00073307|Primary|Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.|||days||95% Confidence Interval|Median
2850564|NCT00073307|Primary|Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.|||days||95% Confidence Interval|Median
2850565|NCT00073073|Secondary|Number of Serum and Breast Tissue Samples Collected for Exploratory Proteomic Profiles at One Year||1 year|Outcome not measured||||||
2850566|NCT00073073|Secondary|Effect of Exemestane on Autocrine Prolactin and Breast Tissue Prolactin Receptor at One Year||1 year|Outcome not measured||||||
2850567|NCT00073073|Secondary|Effect of This Drug on Breast Tissue Trefoil Factor 1 and Proliferating Cell Nuclear Antigen Expression, Prolactin, and Breast Tissue Prolactin Receptor at 1 Year||1 year|Change in breast tissue trefoil factor 1|||percent change from baseline||95% Confidence Interval|Mean
2850568|NCT00073073|Secondary|Absolute Change of Lipid Profiles on Exemestane From Baseline||1 year|Change in total cholesterol|||mg/dl||Standard Deviation|Mean
2850569|NCT00073073|Secondary|Effect of This Drug on Serum Hormones, Insulin-like Growth Factor Pathway Components, and Leptin at 3 Months and 1 Year||3 months and 1 year|Data were not collected||||||
2850570|NCT00073073|Secondary|Change in Breast Density at 2 Years||2 years||||percent change from baseline||95% Confidence Interval|Mean
2850571|NCT00073073|Secondary|Effect of This Drug on Bone Mineral Density||1 year||||percent change from baseline||95% Confidence Interval|Mean
2850572|NCT00073073|Primary|Percent Change in Mammographic Density at 1 Year on Exemestane||1 year||||percent change from baseline||95% Confidence Interval|Mean
2851590|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 32|Percentage of participants with Viral Load < 400 copies/mL|week 32||||Percentage of participants|||Number
2850574|NCT00073021|Secondary|Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Left Sided Disease = proctitis, proctosigmoiditis or left-sided colitis|||Percentage of Participants|||Number
2850575|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.|||Scores on a Scale||Standard Error|Mean
2850576|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.|3 Weeks|All Randomized Patients with Moderate Disease[PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.|||Scores on a Scale||Standard Error|Mean
2850577|NCT00073021|Secondary|Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6|PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
2850578|NCT00073021|Secondary|Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6|PFA - 0=generally well, 1=fair, 2=poor, 3=terrible|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
2850579|NCT00073021|Secondary|Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6|Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
2850580|NCT00073021|Secondary|Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6|0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
2850581|NCT00073021|Secondary|Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population|Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline|||Percentage of Participants|||Number
2850582|NCT00073021|Secondary|Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population|Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations)|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6|||Percentage of Participants|||Number
2850583|NCT00073021|Secondary|Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population|UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]|6 weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline.|||Scores on a Scale||Standard Error|Mean
2850584|NCT00073021|Primary|Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline|||Percentage of Participants|||Number
2850585|NCT00073008|Secondary|Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review|Comparison of the specific cell type (histology) of non-small cell lung cancer from participant's tissue samples, as determined by local pathologist, to the type determined by an independent pathologist. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, NSCLC histology was not analyzed.|Anytime from Baseline through end of study|||||||
2850837|NCT00069576|Secondary|Number of Participants Who Experienced Preeclampsia|Number of participants who experienced preeclampsia|From time of randomization through delivery (up to 17 weeks)|Data was missing for 9 women in the treatment group and 18 women in the control group.|||Participants|||Count of Participants
2850587|NCT00073008|Secondary|Time to Tumor Progression|Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed.|From randomization and then every 8 weeks to disease progression or death|||||||
2850588|NCT00073008|Secondary|Duration of Response|For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed.|Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death|||||||
2850589|NCT00073008|Secondary|Time to Response|Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed.|From randomization and then every 8 weeks to time of response to study drug|||||||
2850590|NCT00073008|Secondary|Quality of Life|Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed.|Baseline and then every 4 weeks through end of treatment|||||||
2850591|NCT00073008|Secondary|Pharmacogenetics (PgX)|To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed.|From randomization at every 4-week assessment through end of treatment|||||||
2850592|NCT00073008|Secondary|Pharmacokinetics (PK) of Lapatinib|To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed.|From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug|||||||
2850593|NCT00073008|Secondary|The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue|To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed.|From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples|||||||
2850594|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Non-Targeted Population|Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.|||percentage of participants|||Number
2850595|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Targeted Population|Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Targeted Population|||percentage of participants|||Number
2850596|NCT00073008|Other Pre-specified|Tumor Response in the Non-Targeted Population Through the End of Treatment|Baseline and then every 8 weeks through end of treatment (end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event or participant decision)|Baseline and then every 8 weeks through end of treatment|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.|||participants|||Number
2850597|NCT00073008|Primary|Tumor Response in the Targeted Population Through the End of Treatment|Disease progression and tumor response (number of participants achieving a complete response [CR] or partial response [PR]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment.|Baseline and then every 8 weeks through end of treatment|Targeted Population: all randomized participants who received at least one dose of study drug and had either the histological subtypes of adenocarcinoma with bronchioloalveolar carcinoma features or pure bronchioloalveolar carcinoma, or were never smokers with any histology of non-small cell lung cancer (NSCLC)|||participants|||Number
2850612|NCT00072384|Primary|Group C Eyes - Treatment Failure Within One Year|"Each Group C eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the Mean measure type."|One year|Four eligible patients had at least one Group C eye to contribute to the analysis|||Probability of treatment failure|Eyes|Standard Deviation|Mean
2851625|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 2||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2850598|NCT00072761|Primary|Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct|The primary end point was the recurrence of infarct or hemorrhage as determined by neuroimaging, clinical evidence of permanent neurologic injury, or both. A new infarct had to meet the criteria for a silent cerebral infarction; an enlarged silent cerebral infarct was defined as a previously identified silent cerebral infarct that increased by at least 3 mm along any linear dimension in any plane on MRI.|From study entry to study exit|Randomization assignments were provided by the statistical data coordinating center with the use of a permuted block design, with stratification according to site, age, and sex. Participants were assigned in a 1:1 ratio to the observation or transfusion group and were followed until study exit or study endpoint.|||infarct recurrence per 100 person years|||Number
2850599|NCT00072475|Primary|Time to Transformation to AML|Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
2850600|NCT00072475|Secondary|Progression-free Survival|"Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.~Progression is defined as~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts~For patients with 10-19% bone marrow blasts: increase to ≥20% blasts~One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent~Progression after HI: Includes one or more of the following~Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L~Reduction in HGB concentration by at least 2 g/dL~Becoming transfusion dependent"|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
2850601|NCT00072475|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)||||months||95% Confidence Interval|Median
2850602|NCT00072475|Secondary|Duration of Response|"Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method.~Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure)."|5 yrs|Per the description, only patients who achieved a response were evaluable for this outcome.|||months||95% Confidence Interval|Median
2850603|NCT00072475|Primary|Number of Participants With Response|"Response was measured by International Standardized Response Criteria for MDS~Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia~Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.~Hematologic improvement:~Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements~Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L)~Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)"|Duration of study (up to 5 years)||||participants|||Number
2850604|NCT00072449|Secondary|Toxicity|patients only received drug for 8 weeks|8 weeks - 2 cycles||||related episodes|||Number
2850605|NCT00072449|Secondary|Overall Survival|survival was evaluated q 2months|47 months||||months||95% Confidence Interval|Median
2850606|NCT00072449|Secondary|Progression-free Survival|pt had MRI every 3 months|pt had MRI q3months||||days||95% Confidence Interval|Median
2850607|NCT00072449|Primary|Radiographic Response|it at any time point patient progresses no more scans are required, patient is off study|1 month, 2 months and then q3months||||participants|||Number
2850608|NCT00072384|Secondary|Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement|The association between the probability of experiencing treatment failure vs. no failure in a C eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. The association between the probability of experiencing treatment failure vs. no failure in a D eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia.|From the date of enrollment assessed up to 12 months|According to the initial sites of involvement, 4 patients were analyzed in Group C eyes and 20 patients were analyzed for Group D eyes|||Eyes|||Number
2850609|NCT00072384|Secondary|Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence|Sites of disease recurrence for Group C and Group D eyes where treatment failure was detected|From the date of enrollment assessed up to 36 months|1 patient had at least one Group C eye and 11 patients had at least one Group D eye that experienced treatment failure. There were a total of 13 Group D eyes that experienced treatment failure.|||Eyes|||Number
2850610|NCT00072384|Secondary|Toxicity Associated With Chemotherapy|The number of patients that experience CTC Version 4 grade 3 or higher toxicities of any kind.|From date of enrollment until termination of protocol therapy assessed up to 72 weeks|22 eligible patients were evaluable for the occurrence of grade 3 or higher toxicity of any kind.|||Patients|||Number
2850611|NCT00072384|Secondary|Event-free Survival (EFS)|Proportion of patients event free at 1 year following enrollment. Event free survival time is computed as the time to study entry until disease relapse/progression, secondary malignancy, or death.|One year after study enrollment|22 eligible patients were considered for this endpoint.|||Percentage probability||95% Confidence Interval|Number
2850838|NCT00069576|Secondary|Number of Neonates Who Experienced Shoulder Dystocia|Number of neonates who experienced shoulder dystocia during labor and delivery|During the process of labor through delivery|Data was missing for 9 women in the treatment group and 18 women in the control group.|||Participants|||Count of Participants
2850613|NCT00072384|Primary|Group D Eyes - Treatment Failure Within One Year|"Each Group D eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the Mean measure type."|One year|Twenty eligible patients had at least one Group D eye to contribute to the analysis. A total of 25 Group D eyes were available for analysis.|||Probability of treatment failure|Eyes|Standard Deviation|Mean
2850614|NCT00072293|Secondary|Site of Recurrence|Site of recurrence of breast cancer|Reported after a median follow-up of 60 months|Intention-to-treat|||participants|||Number
2850615|NCT00072293|Secondary|5-year Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat|||percentage of participants|||Number
2850616|NCT00072293|Primary|5-year Disease-Free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat|||percentage of participants|||Number
2850617|NCT00072280|Primary|"Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm"|Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).|Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)|By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population.|||participants|||Number
2850618|NCT00072189|Secondary|Progression-free Survival|"Estimated using the product-limit method of Kaplan and Meier.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years||||months||95% Confidence Interval|Median
2850619|NCT00072189|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 7 years||||months||95% Confidence Interval|Median
2850620|NCT00072189|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 7 years||||percentage of responding participants|||Number
2850621|NCT00072176|Primary|Progression-free Survival (Tumor Progression)|Time to tumor progression or death|5 years|All patients who were evaluable for response|||months||95% Confidence Interval|Median
2850622|NCT00072176|Primary|Objective Clinical Response Rate|Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.|Up to 5 years|Patients who were evaluable for response.|||percentage of patients with response||95% Confidence Interval|Number
2850623|NCT00071981|Secondary|Median Overall Survival (OS)|OS was defined as the time from registration to death from any cause.|assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years|148 eligible and treated patients were included in the analysis|||months||95% Confidence Interval|Median
2850624|NCT00071981|Secondary|Objective Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.|Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination|148 eligible and treated patients were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2850625|NCT00071981|Secondary|Helper T Cell Response to Tetanus|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about HTL response to tetanus peptide were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2850626|NCT00071981|Secondary|Helper T-cells Response to 6MHP|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about helper T cell response were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2850627|NCT00071981|Primary|Cytotoxic T-cell Lymphocytes (CTL) Response Rate|Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.|Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8|140 eligible and treated patients who had CTL response data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2850628|NCT00072566|Secondary|Median Overall Survival|Calculated using the method of Kaplan-Meier.|Time from first day of treatment to time of death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2850774|NCT00070499|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.|Eligible patients who started therapy|||Participants with a given type of AE|||Number
2850629|NCT00072566|Secondary|Response Rate Based on the RECIST|Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.|Up to 3 years||||percentage of responding patients|||Number
2850630|NCT00072566|Primary|Median Time to Progression|Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.|Up to 3 years||||months||95% Confidence Interval|Median
2850631|NCT00072514|Secondary|Peripheral Blood Stem Cell Collection|Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.|Up to 12 weeks|Successful PBSC collection is only considered in those patients that attempted PBSC collection.|||Participants|||Count of Participants
2850632|NCT00072514|Secondary|Hematologic and Non-hematologic Adverse Events.|Count of participants with grade 3/4 hematologic and non-hematologic adverse events.|3-4 weeks after completion of study treatment||||Participants|||Count of Participants
2850633|NCT00072514|Secondary|Overall and Complete Response Rates|Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)|3-4 weeks after completion of study treatment||||percentage of participants||95% Confidence Interval|Number
2850634|NCT00072514|Primary|Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules|Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.|At 3-4 weeks after completion of study treatment||||Participants|||Count of Participants
2850635|NCT00071812|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 48/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBRA99/NCT00583557).|Up to 56 weeks||||percentage of participants|||Number
2850636|NCT00071812|Secondary|Mean Change in Modified Total Sharp Score at Week 24|The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a modified total Sharp score at baseline and at Week 24.|||scores on a scale||Standard Error|Mean
2850637|NCT00071812|Secondary|Time to First DAS28 Response|"DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a good or a moderate improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1."|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Full Range|Median
2850638|NCT00071812|Secondary|Mean Change in Disease Activity Score 28 (DAS28) at Week 24|DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a baseline and a Week 24 DAS28 score.|||scores on a scale||Standard Error|Mean
2850639|NCT00071812|Secondary|Time to First ACR70 Response, Based on ESR|Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.|0 to 24 weeks|||||||
2850640|NCT00071812|Secondary|Time to First ACR50 Response, Based on ESR|Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.|0 to 24 weeks|||||||
2850641|NCT00071812|Secondary|Time to First ACR20 Response, Based on ESR|The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Inter-Quartile Range|Median
2850642|NCT00071812|Secondary|Percentage of Patients With an ACR70 Response at Week 24, Based on ESR|An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percentage of participants|||Number
2850643|NCT00071812|Secondary|Percentage of Patients With an ACR50 Response at Week 24, Based on ESR|An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percentage of participants|||Number
2850644|NCT00071812|Primary|Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)|An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percentage of participants|||Number
2850645|NCT00071799|Primary|Number of Participants Who Died|Count of participants who died during the study|42 months|Intent to treat population|||participants|||Number
2850646|NCT00071799|Post-Hoc|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML) Based on the Last Bone Marrow Assessment|A sensitivity analysis of time to transformation to AML during the entire study was performed based on the last bone marrow assessment. Patients were censored based on the last bone marrow assessment.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.|||months||95% Confidence Interval|Median
2850647|NCT00071799|Secondary|Number of Participants in Different Categories of Adverse Experiences During Core Study Period|Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.|Day 1 (randomization) to 42 months|Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.|||participants|||Number
2850648|NCT00071799|Secondary|Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals|The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.|Day 1 (randomization) to 42 months|Intent to treat population|||infections per treatment year|||Number
2850649|NCT00071799|Secondary|Duration of Any Hematologic Improvement|The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. Participants showing hematologic improvement were 48 in azacitidine and 31 in conventional care.|||months||95% Confidence Interval|Median
2850650|NCT00071799|Secondary|Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause|The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. The number of participants with disease progression, relapse after remission or death from any cause is 84 for azacitidine and 79 for conventional care. Remaining participants were censored.|||months||95% Confidence Interval|Median
2850651|NCT00071799|Secondary|Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee|"IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L.~Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements.~Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase.~Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L."|Day 1 to 42 months|Intent to treat population.|||participants|||Number
2850652|NCT00071799|Secondary|Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)|"Investigator determined responses followed IWG criteria for~complete remission(CR): repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia~partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment~stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months."|Day 1 to 42 months|Intent to treat population.|||participants|||Number
2850653|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
2850654|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
2850808|NCT00069823|Secondary|Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)|Mean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
2850655|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
2850656|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population|||participants|||Number
2850657|NCT00071799|Secondary|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)|The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.|||months||95% Confidence Interval|Median
2850658|NCT00071799|Secondary|Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First|The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.|||months||95% Confidence Interval|Median
2850659|NCT00071799|Primary|Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause|"Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.~Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification."|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and those who were censored.|||months|||Number
2850660|NCT00071799|Primary|Kaplan-Meier Estimates for Median Time to Death From Any Cause|Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and participants who were censored.|||months|||Number
2850661|NCT00071890|Secondary|AIDS Events|AIDS defined events according to CDC classification|Overall study|"IL-2 arm : Oesophageal candidasis at W196~Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104"|||event|||Number
2850662|NCT00071890|Secondary|Changes in CD4 Counts at Week 72||week 72||||cells per mm3||Inter-Quartile Range|Median
2850663|NCT00071890|Primary|Proportion of Patients Without Failure of Strategy From Week 0 to Week 72|"A failure of strategy is defined on the first occurrence of one of the following events:~CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks~Planned interruption of therapy at Wk24 cannot be done for any reason;~Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason~Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I)~Subject expires between Wk0 and Wk72 (whatever the cause of death)~Subject is lost to follow up"|week 72|Intent to treat analysis, missing = failure.|||Pourcentage||95% Confidence Interval|Number
2850664|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2850665|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2850666|NCT00071760|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2850667|NCT00071760|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population||||||
2850668|NCT00071760|Secondary|Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population||||||
2850669|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10|Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.|Weeks (W) 2, 24, and 48/premature study discontinuation|Safety Population|||participants|||Number
2850670|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4|P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.|Weeks 2, 24, and 48/premature study discontinuation|Safety Population|||participants|||Number
2850671|NCT00071760|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire|A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant's last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2850672|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable|||participants|||Number
2850673|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.|||participants|||Number
2850674|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).|Week 48|PK Population. Only those participants contributing data were analyzed.|||mL/min||95% Confidence Interval|Geometric Mean
2850675|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.|||mL/min/kg||95% Confidence Interval|Geometric Mean
2850676|NCT00071760|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
2850677|NCT00071760|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
2850678|NCT00071760|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population. Only those participants contributing data were analyzed.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
2850679|NCT00071760|Secondary|Number of Participants With the Indicated Virological Outcome at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).|Week 48|ITT-E Population. Only those participants contributing data were analyzed.|||participants|||Number
2850680|NCT00071760|Secondary|Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.|||Percentage of cells||Inter-Quartile Range|Median
2850681|NCT00071760|Secondary|Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.|||Percentage of cells||Inter-Quartile Range|Median
2850682|NCT00071760|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2850683|NCT00071760|Secondary|Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.|||log10 copies/mL||Inter-Quartile Range|Median
2850684|NCT00071760|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.|||log10 copies/mL||Inter-Quartile Range|Median
2850685|NCT00071760|Secondary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|Intent-to-Treat Exposed (ITT-E) Population: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2850686|NCT00071760|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to an AE|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.|||participants|||Number
2850687|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.|||participants|||Number
2850688|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities|TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data were analyzed.|||participants|||Number
2850689|NCT00071760|Primary|Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, and 48|Safety Population. Only those participants contributing data were analyzed.|||Units per liter (U/L)||Inter-Quartile Range|Median
2850690|NCT00071760|Primary|Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48|Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population. Only those participants contributing data were analyzed.|||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
2850809|NCT00069823|Secondary|Change in Asthma Symptom Utility Index (ASUI)|Mean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
2850691|NCT00071760|Primary|Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48|Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.|||International units per liter (IU/L)||Inter-Quartile Range|Median
2850692|NCT00071760|Primary|Plasma Unbound APV Percent Protein Binding (%Cτ)|Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Percentage of total APV Cτ unbound||Standard Deviation|Mean
2850693|NCT00071760|Primary|Plasma Unbound APV Cτ|"Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or free APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state."|Week 48|PK Population. Only those participants contributing data were analyzed.|||µg/mL||Standard Deviation|Mean
2850694|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.|||mL/min||95% Confidence Interval|Geometric Mean
2850695|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
2850696|NCT00071760|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2850697|NCT00071760|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
2850698|NCT00071760|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|"Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr."|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.|||Hr per microgram/milliliter (hr*µg/mL)||95% Confidence Interval|Geometric Mean
2850699|NCT00071721|Secondary|Participant's Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)|ADCS-Clinical Global Impression of Change (ADCS-CGIC) provides a means to reliably assess global change from baseline. It provides a semi-structured format to allow clinicians to gather necessary clinical information from both the participant and informant, in order to make an overall impression of clinical change. The range of this instrument is 1 to 7 with lower numbers indicating improvement and higher numbers indicating a worsened state.|24 months||||Units on a scale||Standard Deviation|Mean
2850700|NCT00071721|Secondary|Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version|The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
2850701|NCT00071721|Secondary|Global Severity of Dementia Using the CDR Sum of Boxes|Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
2850702|NCT00071721|Secondary|Functional Performance Assessed by the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory|Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
2850703|NCT00071721|Secondary|Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)|Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|24 months||||Units on a scale||Standard Deviation|Mean
2850704|NCT00071721|Primary|Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician|NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician's judgment. In the NPI, the subject responds to 'Yes' or 'No' questions. Then it is determined how often psychosis or agitation occurs and if it is mild, moderate or severe.|24 months||||Participants|||Number
2850705|NCT00071513|Secondary|School Attachment|"School attachment measure consisted of 4 items. Item responses range from 0 (unsatisfied, rarely attended, not involved, etc.) to 6 (highly satisfied, regularly attended, very involved, etc). Scores could range from 0 to 36 with higher scores indicating more positive school attachment. Item were:~My overall satisfaction with classes was… Overall, how safe did school feel last semester… Overall, how friendly did school feel… How involved were you in school activities…"|18 months|T-test differences for HSTS versus Brief Intervention on the School Attachment scale.|||units of a scale||Standard Deviation|Mean
2850706|NCT00071513|Primary|Change in Short Moods and Feelings Questionnaire (SMFQ)|"The Short Moods and Feelings Questionnaire is a 13 item measure of level of self reported depressive symptoms. Each item in scored on a 3-point Likert scale as follows: True (0), Sometimes (1), and Not True (2) rated within the timeframe of the previous two weeks. A total score is obtained; scores can range from 0 to 26. Total scores of 12 or higher may signify that a child/adolescent is suffering from depression. Higher scores on this scale suggest a worse outcome or greater endorsement of depressive symptoms. Change is measured based on two time points baseline to the 18 months follow-up assessment."|Baseline to 18 months|The main study hypothesis was that at-risk middle school students randomly assigned to participate in the CAST-T/HSTS versus the Brief Intervention would demonstrate a greater reduction in self-reported depressive symptoms after the 8th grade intervention as well as lower rate of increase in depressive symptoms at the 18 mos. follow-up.|||units on a scale||Standard Deviation|Mean
2850707|NCT00071487|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).|Up to 84 weeks||||percentage of participants|||Number
2850708|NCT00071487|Secondary|Percentage of Patients With a Reduction in Prednisone Dose|Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.|Baseline, weeks 40 to 52|Analysis was performed on a subgroup of the MITT population, which included only patients with baseline prednisone dose > 7.5 mg/day.|||percentatge of particpants|||Number
2850709|NCT00071487|Secondary|Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks|SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Inter-Quartile Range|Median
2850710|NCT00071487|Secondary|Area Under the Curve (AUC) of BILAG Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||ratio score*days||Standard Error|Mean
2850711|NCT00071487|Secondary|Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percent change||Standard Error|Mean
2850712|NCT00071487|Secondary|Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||ratio score*days||Standard Error|Mean
2850713|NCT00071487|Secondary|Percentage Change From Baseline in SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percent change||Standard Error|Mean
2850714|NCT00071487|Primary|Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)|"The SLE Flare Index categorized SLE flare as mild or moderate or severe based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe)."|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.|||days||Inter-Quartile Range|Median
2850715|NCT00071487|Primary|Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.|||percent change||Standard Error|Mean
2850716|NCT00071396|Primary|Overall Response|Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.|After each 4 week course of treatment|Analysis treated population 41 evaluable patients (44 treated, 3 not evaluable for response).|||Participants|||Number
2850717|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||Units on a scale||Standard Deviation|Mean
2850718|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||Units on a scale||Standard Deviation|Mean
2850719|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||Units on a scale||Standard Deviation|Mean
2850720|NCT00071110|Primary|Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10|Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.|Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.|||participants|||Number
2850721|NCT00071032|Secondary|Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke)||In-hospital|||||||
2850722|NCT00071032|Secondary|Myocardial Infarction||In-hospital|||||||
2850723|NCT00071032|Secondary|Length of Stay in Hospital||In-hospital|||||||
2850724|NCT00071032|Secondary|Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy)||30 and 60 days|||||||
2850725|NCT00071032|Secondary|Disposition Status (i.e., Nursing Home Placement)||60 days|||||||
2850726|NCT00071032|Secondary|Survival||30-daym, 60- day and long term up to 5 years|||||||
2850727|NCT00071032|Secondary|Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke)||In hospital|||||||
2850728|NCT00071032|Secondary|Myocardial Infarction, Unstable Angina, or Death for Any Reason||In-hospital||||participants|||Number
2850729|NCT00071032|Primary|Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death|ascertained via telephone follow-up|60 days after randomization||||participants|||Number
2850730|NCT00071006|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment|Analysis for this particular endpoint was not conducted due to lack of efficacy.|||Days||95% Confidence Interval|Median
2850731|NCT00071006|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose) and every 4 weeks up to 35 weeks|||||||
2850732|NCT00071006|Secondary|Plasma Vascular Endothelial Growth Factor (VEGF) Concentration|VEGF promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Plasma VEGF concentration evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.|||pg/mL||Standard Deviation|Mean
2850733|NCT00071006|Secondary|Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation|Vascular endothelial growth factor (VEGF) promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Mononuclear (MNC) cell VEGF receptor expression and phosphorylation was assessed by in situ western blot analysis. VEGFR-1 and VEGFR-2 evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.|||picograms (pg)/mL||Standard Deviation|Mean
2850734|NCT00071006|Secondary|Bone Marrow Micro Vessel Density (MVD)|Bone marrow MVD in tumors is a measure of angiogenesis and a prognostic indicator that correlates with an increased risk of metastasis in various cancers and with overall and relapse free survival in participants with AML or MDS. Bone marrow biopsies and bone marrow clot samples were assessed for MVD (cluster of differentiation 31 [CD31] staining).|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks|Data was not summarized for this particular endpoint due to lack of efficacy.|||vessels/square millimeter (mm^2)||Standard Deviation|Mean
2850735|NCT00071006|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks|Analysis for this particular endpoint was not conducted due to lack of efficacy.|||Days||95% Confidence Interval|Median
2850736|NCT00071006|Secondary|Percentage of Participants With Hematologic Improvement (HI)|HI was described by the number of individual and positively affected cell lines (Erythroid response, Platelet response, Neutrophil response). Improvements must last at least 2 months.|Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Analysis for this particular endpoint was not conducted due to lack of efficacy.|||Percentage of participants||95% Confidence Interval|Median
2850737|NCT00071006|Primary|Percentage of Participants With Objective Response (OR)|Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.|||Percentage of participants||95% Confidence Interval|Number
2850738|NCT00070941|Primary|Change in Hamilton Depression Scale|very severe, >23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)|12 weeks||||units on a scale||Standard Deviation|Mean
2850739|NCT00071058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|60 months, 19 days||||Participants|||Number
2850740|NCT00071058|Primary|Percentage of Participants With a Partial or Complete Response|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all signs and symptoms of tumor for a period of at least 4 weeks. Partial response is defined as at least a 30% decrease in the sum of the longest diameter of all measured lesions lasting for a period of 4 weeks.|Every 6 weeks for up to a year||||Percentage of participants|||Number
2850741|NCT00070707|Secondary|Therapeutic Response to SAR Nasal Symptoms|On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of SAR symptoms with those noted on Day 1. Therapeutic response for SAR symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief).|Day 15 and Day 29|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2850742|NCT00070707|Secondary|Therapeutic Response to Asthma Symptoms|On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of asthma symptoms with those noted on Day 1. Therapeutic response for asthma symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief).|Day 15 and Day 29|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2850743|NCT00070707|Secondary|Change From Baseline in Weekly Average Interference With Daily Activities|Interference with daily activities was rated once each evening using a 4-point scale ranging from 0 (none) to 3 (substantially interfered with activities or not able to perform the activities at all). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850744|NCT00070707|Secondary|Change From Baseline in Weekly Average Interference With Sleep|Interference with sleep was rated once each morning using a 4-point scale ranging from 0 (none) to 3 (substantially interferes with sleep). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850745|NCT00070707|Secondary|Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma|Participants recorded the number of times during the night they awakened due to asthma. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Awakenings||Standard Error|Least Squares Mean
2850810|NCT00069823|Secondary|Change in Juniper Asthma Control Score(JACQ)|Mean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
2850746|NCT00070707|Secondary|Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used|Once daily, participants recorded in their diaries the total number of puffs of albuterol/salbutamol used in each 24-hour period. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Number of puffs||Standard Error|Least Squares Mean
2850747|NCT00070707|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%)|Measured by the investigator (or a designated assistant) using a spirometer, FEF25%-75% is the average forcibly expelled air flow rate, measured between 75% and 25% of FVC.|Baseline, Day 15 and Day 29|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Liters/sec||Standard Error|Least Squares Mean
2850748|NCT00070707|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Measured by the investigator (or a designated assistant) using a spirometer, FVC is the total volume of air forcibly expelled from the lungs after taking the deepest breath possible.|Baseline, Day 15 and Day 29|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Liters||Standard Error|Least Squares Mean
2850749|NCT00070707|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Measured by the investigator (or a designated assistant) using a spirometer, FEV1 is the volume of air forcibly expelled from the lungs in one second.|Baseline, Day 15 and Day 29|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Liters||Standard Error|Least Squares Mean
2850750|NCT00070707|Secondary|Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR)|Participants used a peak flow meter to measure the rate of air forcibly expelled from the lungs. They performed triplicate PEFR measurements in the morning prior to taking their study medication and again in the evening, and documented the highest of the three values in their diaries. A day with worsening asthma was any day during which a decrease from baseline in morning (AM) PEFR of more than 25% occurred. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Liters/min||Standard Error|Least Squares Mean
2850751|NCT00070707|Secondary|Change From Baseline in AM and PM Nasal Congestion Symptom Score|Nasal congestion is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal congestion (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal congestion for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850752|NCT00070707|Secondary|Change From Baseline in AM and PM Nasal Sneezing Symptom Score|Nasal sneezing is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal sneezing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal sneezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms a were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850753|NCT00070707|Secondary|Change From Baseline in AM and PM Nasal Itching Symptom Score|Nasal itching is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal itching (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal itching for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850754|NCT00070707|Secondary|Change From Baseline in AM and PM Rhinorrhea Symptom Score|Rhinorrhea is a symptom of seasonal allergic rhinitis (SAR) assessed by participants using diary cards to record morning and evening rhinorrhea (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her rhinorrhea for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Rhinorrhea was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850811|NCT00069823|Secondary|Pulmonary Function: Change in PC20|Mean Change in the dose of methacholine that results in a 20% drop in FEV1|Baseline to 24 Weeks||||mg/ml||95% Confidence Interval|Mean
2850812|NCT00069823|Secondary|Pulmonary Function: Change in Peak Flow Rate|Mean change from baseline to 24 weeks in the peak flow rate - how forceful patient can blow out air|Baseline to 24 Weeks||||liters/min||95% Confidence Interval|Mean
2850755|NCT00070707|Secondary|Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS)|The Total Nasal Symptom Severity (TNSS) is the sum of severity scores for 4 nasal symptoms: nasal rhinorrhea, nasal stuffiness/congestion, sneezing, and nasal itching as assessed in the participant diaries. The severity of each nasal symptom was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]); minimum TNSS=0; maximum TNSS=12. A decrease in TNSS indicated an improvement in nasal symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850756|NCT00070707|Secondary|Change From Baseline in Pulmonary Auscultation/Wheezing Assessment|Wheezing was assessed by the investigator or designee based upon pulmonary auscultation (listening with a stethoscope) and reported in the case report form as present or absent. The count of wheezing presence (yes, no) at visits was summarized.|Baseline, Day 15 and Day 29|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Participants|||Count of Participants
2850757|NCT00070707|Secondary|Change From Baseline in AM and PM Chest Tightness Symptom Score|Chest tightness is an asthma symptom assessed by participants using diary cards to record morning and evening chest tightness (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her chest tightness for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). The severity of chest tightness was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850758|NCT00070707|Secondary|Change From Baseline in AM and PM Difficulty Breathing Symptom Score|Difficulty breathing is an asthma symptom assessed by participants using diary cards to record morning and evening difficulty breathing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her difficulty breathing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Difficulty breathing was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850759|NCT00070707|Secondary|Change From Baseline in AM and PM Wheeze Symptom Score|Wheezing is a symptom of asthma. The wheezing assessment was based on participant diary data only. Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her wheezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Wheeze severity was rated on a 4-point scale (0=no wheezing [best score] to 3=wheezing was hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850760|NCT00070707|Secondary|Change From Baseline in AM and PM Cough Symptom Score|Cough is an asthma symptom assessed by participants who used diary cards to record morning and evening cough (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her coughing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Cough was rated on a 4-point scale (0=no symptoms [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). Reduction in score indicated an improvement in cough symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850761|NCT00070707|Primary|Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)|Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).|Baseline up to Week 4|All randomized participants who had at least one post-baseline assessment at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2850762|NCT00003907|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any causes.|Assessed every 3 months for 2 years, then every 6 months for 3 year.|all eligible and treated patients|||Months||90% Confidence Interval|Median
2850763|NCT00003907|Secondary|Tumor Response|Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.|Assessed every 6 weeks|all eligible and treated patients|||Proportion of participants||90% Confidence Interval|Number
2850764|NCT00003907|Primary|Time to Progression|Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions|Assessed every 3 months for 2 years, then every 6 months for 3 year.|All eligible and treated patients|||Months||90% Confidence Interval|Median
2850765|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
2850766|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years|Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
2850767|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
2850768|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years|Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
2850769|NCT00070564|Secondary|Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years|Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
2850770|NCT00070564|Secondary|Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years|Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.|||percentage of participants||95% Confidence Interval|Number
2850771|NCT00070564|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated every 4 weeks while on protocol therapy.|Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.|||Participants|||Number
2850772|NCT00070564|Primary|Overall Survival|Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.|Every 6 months for 5 years|Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
2850773|NCT00070564|Primary|Disease-free Survival|Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.|every 6 months (annually for mammograms) for 5 years|Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
2850813|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity|Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks|Baseline to 24 Weeks||||liters||95% Confidence Interval|Mean
2850775|NCT00070499|Secondary|Two Year Relapse-free Survival|Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.|every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5|Eligible, treated patients who achieved a hematologic complete remission|||Percent of population|||Number
2850776|NCT00070499|Secondary|2-year Overall Survival (OS)|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5|All eligible patients who were treated|||Percent of population|||Number
2850777|NCT00070499|Secondary|Hematologic Response|Hematologic response assesses whether patients' blood counts return to normal|1 month after starting treatment|Eligible, treated patients who were evaluable for hematologic response|||participants|||Number
2850778|NCT00070499|Primary|Molecular Response Rate at 12 Months|Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.|pretreatment and after 12 months of treatment|Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)|||participants|||Number
2850779|NCT00070317|Primary|False Negative Predictive Value (FNPV)|The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases|At the time of Surgery|Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling|||Percentage of participants||90% Confidence Interval|Number
2850780|NCT00070317|Primary|Sensitivity|Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.|At the time of surgery|Eligible and evaluable patients with lymph node metastasis and identified sentinel node|||Percentage of participants||90% Confidence Interval|Number
2850781|NCT00070291|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 1 year.|all 4 enrolled patients|||Months||95% Confidence Interval|Median
2850782|NCT00070291|Primary|Response Rate (Complete and Partial Response)|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.|Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.|all 4 enrolled patients|||Proportion of participants||95% Confidence Interval|Number
2850783|NCT00070135|Secondary|Non-relapse Mortality (NRM)|Percentage of patients who died due to causes other than relapse|Up to 5 years||||percentage of patients|||Number
2850784|NCT00070135|Secondary|2 Year DFS for All Patients|Percentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2850785|NCT00070135|Primary|2 Year Disease Free Survival In Unrelated Donor Recipient Group|"Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A relapse is defined as any of the following:~Reappearance of leukemia blasts cells in peripheral blood~>5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration)~If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with >5% blasts is necessary to meet the criteria for relapse~The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid"|2 years|Participants who received a matched unrelated donor were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2850786|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin clearance. Group 1 and group 2 patients were excluded due to not submitting specimens.|||L/hr||Standard Deviation|Mean
2850787|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin AUC. Group 1 and group 2 patients were excluded due to not submitting specimens.|||ng/(mLxh)||Standard Deviation|Mean
2850832|NCT00069576|Secondary|Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity|Child waist circumference >90th percentile for age, sex and race/ethnicity based on a study examining cross-sectional data from the Third National Health and Nutrition Examination Survey (NHANES III)|Age 5-10 years||||Participants|||Count of Participants
2850788|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin half life. Group 1 and group 2 patients were excluded due to not submitting specimens.|||hours||Standard Deviation|Mean
2850789|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate apparent volume at steady state of trabectedin of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.|||L||Standard Deviation|Mean
2850790|NCT00070109|Primary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin|The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.|From baseline up to168 hours after trabectedin infusion in course 1|Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate maximum plasma concentration of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.|||ng/mL||Standard Deviation|Mean
2850791|NCT00070109|Primary|Number of Patients With Dose-Limiting Toxicity (DLT)|Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.|1 Cycle|Two pts in Group 1 and 1 pt in Group 2 were excluded because they were removed from therapy prior to the DLT evaluation period and no DLT had been observed. No patients in Groups 3, 4, or 5 were evaluated for DLT.|||participants|||Number
2850792|NCT00070109|Primary|Response (Complete Response [CR] and Partial Response [PR])|Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.|No pts in Group 1 were evaluated for response. 1 pt in Group 3 is excluded because the pt was removed from protocol therapy after cycle 3 when a cardiac evaluation was missed. The pt was removed prior to disease assessment on protocol therapy. 1 pt enrolled in Group 4 was excluded because patient was removed from therapy prior to chemotherapy.|||participants|||Number
2850793|NCT00070018|Primary|Progression-free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter||||percentage of participants||95% Confidence Interval|Number
2850794|NCT00069953|Secondary|Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection||Analysis occurs with the primary outcome measure.|||||||
2850795|NCT00069953|Secondary|Frequency of Major (Grade 4) Acute Treatment-related Toxicities||From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).|||||||
2850796|NCT00069953|Primary|Overall Survival (1-year Rate Reported)|One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850797|NCT00069784|Other Pre-specified|Number of Patients With First Occurrence of Any Type of Cancer|Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee.|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population.|||participants|||Number
2850798|NCT00069784|Other Pre-specified|Number of Patients With Various Types of Symptomatic Hypoglycemia Events|"Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant's diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed.~Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following:~the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or~the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|on-treatment period (median duration of follow-up: 6.2 years)|The population analyzed was the safety population consisting of all randomized and treated patients (who received at least one dose of study drug) for the insulin glargine group and of all randomized patients for the standard care group.|||participants|||Number
2850799|NCT00069784|Secondary|Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG|The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2).|from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)|The analysis was based on the subgroup of the intent-to-treat (ITT) population without diabetes at randomization.|||percentage of patients|||Number
2850800|NCT00069784|Secondary|Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)|"The composite outcome used to analyze microvascular disease progression contained components of clinical events:~the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR);~the development of blindness due to DR;~the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events:~doubling of serum creatinine; or~progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine])."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."|||participants|||Number
2850801|NCT00069784|Secondary|Total Mortality (All Causes)|Number of deaths due to any cause|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population, which was all randomized participants, regardless of compliance with the protocol.|||participants|||Number
2850802|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)|"Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."|||participants|||Number
2850803|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke|"Number of participants with a first occurrence of one of the above events.~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."|||participants|||Number
2850804|NCT00069823|Secondary|Change in Number of Gastric Symptoms: No. of Symptoms|Mean change|Baseline to 24 Weeks||||symptoms||95% Confidence Interval|Mean
2850805|NCT00069823|Secondary|Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score|Mean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
2850806|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
2850807|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks||||score||95% Confidence Interval|Mean
2850839|NCT00069576|Secondary|Number of Participants Who Underwent Cesarean Delivery|Delivery by cesarean section|Delivery|Data was missing for 9 women in the treatment group and 18 women in the control group.|||Participants|||Count of Participants
2850814|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator FEV1|Mean change in pre-bronchodilator FEV1 - forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups.|Baseline to 24 Weeks|The analyses are based on data from 191 participants in the placebo group and 201 in the esomeprazole group, with the following exception: 41 participants in the placebo group and 37 in the esomeprazole group for measurement of 20% post-diluent baseline (PC20).|||liters||95% Confidence Interval|Mean
2850815|NCT00069823|Secondary|Night Awakening|Rate of awakening at night because of asthma symptoms|Baseline to 24 Weeks||||events per person-year|||Number
2850816|NCT00069823|Secondary|Use of Rescue Medications|Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.|Baseline to 24 Weeks||||events per person-year|||Number
2850817|NCT00069823|Secondary|Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists||Baseline to 24 Weeks||||events per person-year|||Number
2850818|NCT00069823|Secondary|Exacerbation Components: New Use of Oral Corticosteroids||Baseline to 24 Weeks||||events per person year|||Number
2850819|NCT00069823|Primary|Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion|Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma|Baseline to 24 Weeks||||events per person year|||Number
2850820|NCT00069823|Secondary|Exacerbation Components: Urgent Care Visit||Measured at Month 6||||events per person-year|||Number
2850821|NCT00069823|Secondary|Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days||Baseline to 24 Weeks||||events per person-year|||Number
2850822|NCT00069641|Secondary|Percent Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 53|Cardiac LVMI was determined by echocardiography. Change was calculated at Week 53 from baseline. LVMI is the LVM, in grams indexed to BSA, in square meter [m^2]. LVMI in g/m^2 = LVM divided by BSA.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||percent change||Standard Error|Mean
2850823|NCT00069641|Secondary|Mean Cardiac Left Ventricular Mass Index (LVMI) at Baseline|Cardiac LVMI was determined by echocardiography. LVMI is the left ventricular mass (LVM, in grams [g]) indexed to body surface area (BSA), in square meter [m^2]. LVMI (in gram per square meter [g/m^2]) = LVM divided by BSA.|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||gram per square meter (g/m^2)||Standard Error|Mean
2850824|NCT00069641|Primary|Ranked Adjusted 2-Component Composite Variable Score Based on Change From Baseline to Week 53|The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the change from baseline was then ranked. The lowest change value was assigned a rank of 1, the next lowest a rank of 2, etc. The composite score for each participant was the sum of the 2 ranked scores corresponding to the 2 individual components (% predicted FVC and 6MWT) for each participant. Thus, the greater the composite score (greater the sum of the ranks of the changes from baseline, where the lowest change was ranked as 1), the greater the improvement.|Baseline, Week 53|Intent-to-treat (ITT) population, Only participants receiving “Idursulfase Weekly” or “Placebo” were to be analyzed for this outcome.|||sum of the ranked scores||Standard Error|Mean
2850825|NCT00069641|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycan (GAG) Levels at Week 53|Mean normalized urine GAG was analyzed using urine testing. Change was calculated at Week 53 from baseline. The urine GAG levels were normalized to urine creatinine and were reported as microgram GAG per milligram creatinine (mcg GAG/mg creatinine).|Baseline, Week 53|ITT population.|||mcg GAG/mg creatinine||Standard Error|Mean
2850826|NCT00069641|Secondary|Percent Change From Baseline in Mean Combined Liver and Spleen Volume at Week 53|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI). Change was calculated at Week 53 from baseline.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||percent change||Standard Error|Mean
2850827|NCT00069641|Secondary|Mean Combined Liver and Spleen Volume at Baseline|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI).|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||milliliter (mL)||Standard Error|Mean
2850828|NCT00069641|Secondary|Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53|Change was calculated at Week 53 from baseline. Global JROM (% of normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.|||percentage of normal range of motion||Standard Error|Mean
2850829|NCT00069576|Other Pre-specified|Mean Gestational Age at Birth|Mean Gestational age at the time of delivery|Delivery||||weeks||Standard Deviation|Mean
2850830|NCT00069576|Secondary|Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL|Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL|Age 5-10 years|The number of children for whom glucose data is available is 390, lower than the larger follow-up sample.|||Participants|||Count of Participants
2850831|NCT00069576|Secondary|Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height|Hypertension ≥ 95th percentile for age, sex and height based on the National Heart, Lung and Blood Institute Expert Panel on Integrated Guidelines for Children and Adolescents.|Age 5 - 10 years||||Participants|||Count of Participants
2850841|NCT00069576|Secondary|Number of Neonates Who Experienced Respiratory Distress Syndrome|Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge|Delivery through hospital discharge up to 120 days|Data was missing for 8 infants in the treatment group and 18 infants in the control group.|||Participants|||Count of Participants
2850842|NCT00069576|Secondary|Number of Neonates Who Received Intravenous Glucose Treatment|Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge.|Delivery through hospital discharge up to 120 days|Data was missing for 10 infants in the treatment group and 18 infants in the control group.|||Participants|||Count of Participants
2850843|NCT00069576|Secondary|Number of Infants Admitted to NICU|Admission to the Neonatal Intensive Care Unit|Delivery through hospital discharge up to 120 days||||Participants|||Count of Participants
2850844|NCT00069576|Secondary|Mean Neonatal Birth Weight|Birth weight in grams|Assessed at delivery||||grams||Standard Deviation|Mean
2850845|NCT00069576|Secondary|Number of Neonates Who Were Small for Gestational Age|Birth weight below the 10th percentile|From time of randomization through delivery (up to 17 weeks)|There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing|||Participants|||Count of Participants
2850846|NCT00069576|Secondary|Mean Neonatal Fat Mass at Delivery||Assessed at delivery||||grams||Standard Deviation|Mean
2850847|NCT00069576|Secondary|Number Participants Who Delivered Preterm|Number of preterm deliveries before 37 weeks gestation|Delivery before 37 weeks gestation||||Participants|||Count of Participants
2850848|NCT00069576|Secondary|Number of Neonates With Macrosomia (Birth Weight > 4000 gm)||Assessed at Delivery|There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing|||Participants|||Count of Participants
2850849|NCT00069576|Secondary|Number of Neonates Who Were Large for Gestational Age at Delivery||From time of randomization through delivery (up to 17 weeks)|There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing|||Participants|||Count of Participants
2850850|NCT00069576|Primary|Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex|Number of children with BMI ≥ 95th percentile for age and sex. BMI is measured as kg / m^2. Standards based on the 2000 Centers for Disease Control growth charts.|Age 5-10 years||||Participants|||Count of Participants
2850851|NCT00069576|Primary|Number of Participants With Composite Neonatal Morbidity|The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.|Delivery through discharge of infant from hospital up to 120 days|The results of some blood tests were not available either because samples were not obtained or were not obtained according to protocol or because they could not be assayed owing to a laboratory processing error. Data were not available in some cases because some women delivered at outside institutions.|||Participants|||Count of Participants
2850852|NCT00069277|Primary|Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.||12 Weeks||||participants|||Number
2850853|NCT00069264|Primary|Determination of the Maximum Tolerated Dose||28 Days||||mg/m^2|||Number
2850854|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||mm/hour||Standard Deviation|Mean
2850855|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mm/hour||Standard Deviation|Mean
2850856|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mm/hour||Standard Deviation|Mean
2850857|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||mg/dl||Standard Deviation|Mean
2850858|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/dl||Standard Deviation|Mean
2850859|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/dl||Standard Deviation|Mean
2850860|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||mg/liter||Standard Deviation|Mean
2850861|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/liter||Standard Deviation|Mean
2850862|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||mg/liter||Standard Deviation|Mean
2850863|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
2850864|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850865|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850866|NCT00069329|Primary|Parent /Patient Pain Rating|Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
2850867|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850868|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850869|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
2850870|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850942|NCT00068601|Secondary|Rate of Ovarian Dysfunction at 2 Years|Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.|2 years|Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 2|||Participants|||Count of Participants
2850871|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850872|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.|||units on a scale||Standard Deviation|Mean
2850873|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850874|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.|||units on a scale||Standard Deviation|Mean
2850875|NCT00069238|Secondary|Clinical Response|Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease.|For patients with response:Restage sites of disease every (q) 3 months for the first year, then q4 months for the second year, and then q6 months for the next 3 years, and yearly thereafter. The timing for these visits may be adjusted + 2 months.||||Participants|||Count of Participants
2850876|NCT00069238|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|67 months and 9 days||||Participants|||Count of Participants
2850877|NCT00069238|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab|MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously every 3 weeks for up to 6 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).|Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days.||||mg|||Number
2850878|NCT00069121|Secondary|Number of Participants With at Least One Adverse Event by Most Severe Intensity|"The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms severe and serious are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details."|From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).|Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received.|||Participants|||Count of Participants
2850879|NCT00069121|Secondary|Overall Survival [Time to Event]|Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.|Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).|Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.|||months||Full Range|Median
2850880|NCT00069121|Secondary|Overall Survival [Number of Events]|Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).|Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2850881|NCT00069121|Secondary|Relapse-Free Survival (RFS) [Time to Event]|A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.|Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).|Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.|||months||Full Range|Median
2850882|NCT00069121|Primary|Disease-Free Survival (DFS) [Time to Event]|Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.|Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).|Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.|||months||Full Range|Median
2850883|NCT00069121|Secondary|Relapse-Free Survival (RFS) [Number of Events]|A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.|Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).|Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2850884|NCT00069121|Primary|Disease-Free Survival (DFS) [Number of Events]|Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.|Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).|Intent-to-Treat Population|||Participants|||Count of Participants
2850885|NCT00069108|Secondary|Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment|Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters|||participants|||Number
2850886|NCT00069108|Secondary|Time To Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters.|||days||95% Confidence Interval|Median
2850887|NCT00069108|Secondary|Duration Of Response|Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized.|||days||95% Confidence Interval|Median
2850888|NCT00069108|Secondary|Time To Response|Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||participants|||Number
2850889|NCT00069108|Secondary|Overall Survival|Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||days||95% Confidence Interval|Median
2850890|NCT00069108|Secondary|Best Overall Response, Independent Review Committee Assessment|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||participants|||Number
2850891|NCT00069108|Secondary|Best Overall Response, Investigators' Assessments|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.|||participants|||Number
2850892|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Per Population|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The PP population included randomized participants who received at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.|||days||95% Confidence Interval|Median
2850893|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Intent To Treat Population|Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent To Treat (ITT) population. Participants were analyzed according to the arm to which they were randomized.|||days||95% Confidence Interval|Median
2850894|NCT00069108|Secondary|Progression Free Survival Based on Independent Review Committee Assessment|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|PP population excluded randomized participants who did not receive at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who had a major violation of protocol inclusion or exclusion criteria.|||days||95% Confidence Interval|Median
2850943|NCT00068601|Primary|Rate of Premature Ovarian Failure at 2 Years|Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.|2 years|Patients who completed the study|||Participants|||Count of Participants
2850895|NCT00069108|Primary|Progression Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The per protocol (PP) population included randomized participants who received at least one dose of capecitabine, 5-FU, or oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.|||days||95% Confidence Interval|Median
2850896|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850897|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850898|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850899|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850900|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Week 1 to Week 54|The ITT population included all randomized participants who provided written informed consent.|||Participants|||Number
2850901|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Week 1 to Week 54|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||Participants|||Number
2850924|NCT00068822|Primary|Patient's Rating of Average Pain at 1 Month|Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.|1 month|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.|||units on a scale||Standard Deviation|Mean
2850956|NCT00068445|Primary|Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)|The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.|From baseline to week 10||||units on a scale||Standard Deviation|Mean
2850902|NCT00069095|Secondary|Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850903|NCT00069095|Secondary|Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850904|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||Percentage of responders|||Number
2850905|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||Percentage of responders|||Number
2850906|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||Percentage of responders|||Number
2850907|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||Percentage of responders|||Number
2850941|NCT00068601|Other Pre-specified|Ovarian Reserve at 1 and 2 Years|"Measurements of ovarian reserve will consist of Day 2 - 4 levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25)."|1 and 2 years|||||||
2851591|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 24|Percentage of participants with Viral Load < 400 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2850908|NCT00069095|Primary|PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850909|NCT00069095|Secondary|Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850910|NCT00069095|Secondary|Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850911|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850912|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850913|NCT00069095|Secondary|PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850914|NCT00069095|Secondary|PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850915|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.|||days||95% Confidence Interval|Median
2850916|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850917|NCT00069095|Primary|Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.|Baseline until disease progression or death, approximately 2 years 6 months|The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.|||days||95% Confidence Interval|Median
2850918|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue|99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001.|3-24 hours||||Percent||Full Range|Median
2850919|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar|A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan.|3 - 24 hours|Percent increase in sestamibi AUC in liver after tariquidar.|||percent increase in sestamibi AUC||Full Range|Median
2850920|NCT00069160|Primary|Clinical Response Rate|Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT.|4 years, 8-11 months||||Percentage of participants|||Number
2850921|NCT00069160|Primary|Geometric Mean of Area Under Curve (AUC0)-24||24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2850922|NCT00069160|Primary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 yrs 8-11 months||||participants|||Number
2850923|NCT00069160|Primary|Geometric Mean of Maximum Concentration of the Drug (Cmax)|In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.|24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable.|||Cmax (ng/mL)||95% Confidence Interval|Geometric Mean
2850957|NCT00068419|Secondary|Percentage of Patients Experiencing Short-term Endocrine Toxicity|The percentage of patients experiencing short-term endocrine toxicity between treatment groups is compared using the chi-square test|At study entry|Data not available for analysis due to no data were collected.||||||
2850925|NCT00068822|Secondary|Patient Well-being at 1 Month|"Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).~Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain).~European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL.~Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability."|Month 1|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.|||units on a scale||Standard Deviation|Mean
2850926|NCT00068822|Primary|Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month|Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.|1 month after procedure|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.|||units on a scale||Standard Deviation|Mean
2850927|NCT00068770|Secondary|Overall Survival|duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme|date pt started treatment to date pt last known alive|latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group|||months||95% Confidence Interval|Mean
2850928|NCT00068770|Primary|Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib|subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported|First dose of celecoxib through completion of radiation, 6 weeks.|"pts who had PK data for the first dose of celecoxib. observations were excluded if sample was not collected within 12 +/- 2h after taking prior dose, was drawn after dosing on same day or determine to be outlier by dixon's test.~PK data was available for 15 pts in the +EIASD group and 12 pts in the -EIASD group"|||(ng/ml)||Standard Deviation|Geometric Mean
2850929|NCT00068718|Secondary|Progression-free Survival|Percentage of patients with progression-free survival|1 year after DLI||||percentage of participants|||Number
2850930|NCT00068718|Secondary|Overall Survival|Percentage patients surviving 1 year post-transplant.|1 year after DLI||||percentage of participants|||Number
2850931|NCT00068718|Secondary|Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant|Percentage of Participants with infections.|100 days after DLI||||percentage of participants|||Number
2850932|NCT00068718|Secondary|Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant|Percentage of Participants with II-IV Acute GVHD|100 days after DLI||||percentage of participants|||Number
2850933|NCT00068718|Secondary|Incidence of Relapse/Progression|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|1 year after DLI||||percentage of participants|||Number
2850934|NCT00068718|Secondary|Incidence of Graft Rejection|Percentage patients with graft rejection.|100 days after DLI||||percentage of participants|||Number
2850935|NCT00068718|Primary|Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD|Percentage of Participants with Grade IV Acute GVHD|100 days after DLI||||percentage of participants|||Number
2850936|NCT00068692|Secondary|Failure Pattern|Type of failures (local/regional recurrence vs. distant recurrence vs. concurrent recurrence vs. second primary cancer vs. deaths) in the analysis population|assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years|All randomized patients|||Participants|||Count of Participants
2850937|NCT00068692|Secondary|Proportion of Sphincter Preservation|Proportion of sphincter preservation was defined as number of patients with sphincter preservation divided by total number of patients randomized to the arm|assessed at primary surgery time|All randomized patients|||proportion of patients||95% Confidence Interval|Number
2850938|NCT00068692|Secondary|3-year Disease Free Survival|Disease free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer and death from any cause, whichever occurred first. 3-year DFS rate was estimated using Kaplan-Meier method.|assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years|All randomized patients|||proportion of patients||95% Confidence Interval|Number
2850939|NCT00068692|Primary|3-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to death from any cause. 3-year OS rate was estimated using Kaplan-Meier method.|assessed every 3 months withihn 2 years of study entry, every 6 monhts between years 3-5 and then annually for 5 years, estimated at 3 years|All randomized patients|||proportion of patients||95% Confidence Interval|Number
2850940|NCT00068601|Secondary|Rate of Ovarian Dysfunction at 1 Year|Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.|1 year|Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 1|||Participants|||Count of Participants
2850944|NCT00068588|Primary|Response Rate of a Combination of GTI-2040 and Capecitabine|Following the dose escalation step, additional patients will be accrued at the MTD and evaluated for disease response using RECIST v1.0 criteria. Patients with confirmed complete or partial response are considered to have responded favorably to treatment.The sample size and early stopping for futility was governed by a two stage Optimum design suggested by Simon. It was assumed that a true response rate less than 25% would not warrant further study of this agent. It was also assumed that a response rate of 45% would be considered promising. In the first stage (following the dose escalation step), 15 evaluable patients were treated. Four or fewer observed responses, would stop accrual, while 5 or more observed would continue accrual for an additional 12 patients during the second stage of the study. Ten or more responses out of 27 patients will be considered evidence warranting further study of the regimen providing toxicity and survival also appear favorable.|Up to 6 years|Response Rate was only assessed at the determined MTD. Additional patients were accrued to determine treatment efficacy at the MTD.|||percentage of patients responding|||Number
2850945|NCT00068588|Primary|Maximum Tolerated Dose Determined by Dose-limiting Toxicities|1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0|21 days||||Patients experiencing DLT|||Number
2850946|NCT00068575|Primary|Median Overall Survival (OS)|Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.|Participants followed till disease progression or death (approximately 6 years)|Analysis by protocol.|||months||95% Confidence Interval|Median
2850947|NCT00068445|Secondary|Change in POMS Total Score [Week 10 Minus Baseline]|The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week. The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.|From baseline to week 10|Participants with POMS scales data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850948|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Pain Interference data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850949|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Pain Relief data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850950|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Pain Now data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850951|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Average Pain data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850952|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]|"The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.~Time Frame:~Up to 1 week post-treatment"|From baseline to week 10|Participants with BPI Least Pain data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850953|NCT00068445|Secondary|Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]|The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to week 10|Participants with BPI Worst Pain data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850954|NCT00068445|Secondary|The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10|The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below. The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.|From baseline to week 10|Participants with Uniscale QOL data at both time points available were assessed.|||units on a scale||Standard Deviation|Mean
2850955|NCT00068445|Primary|Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)|The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below. The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.|From baseline to week 10||||units on a scale||Standard Deviation|Mean
2850958|NCT00068419|Secondary|Percentage of Patients Failure Free at 2 Years by Pathological Response|The failure free survival is compared by the log-rank test between patient subgroups defined by pathological response of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression|From enrollment to up to 2 years|Data not available for analysis due to no data were collected||||||
2850959|NCT00068419|Secondary|Mean Change in Response Measured by MRI|The mean change in response measured by MRI. Response is assessed by the lesion size which is derived from the sum of the longest of the three orthogonal diameters (from MRI) of each target lesion.|From baseline to up to 5 years|Outcome not reported because the required data were not recorded.||||||
2850960|NCT00068419|Secondary|Percentage of Patients With Tumor Response From Imaging|Percentage of patients with a tumor response where tumor response is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST)|Baseline up to 5 years|All eligible patients|||Percentage of participants||95% Confidence Interval|Number
2850961|NCT00068419|Primary|Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.|The percentage of patients experiencing a grade 3 or higher adverse event as assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0|Up to 12 months|All eligible patients|||Percentage of participants||95% Confidence Interval|Number
2850962|NCT00068419|Primary|Percentage of Patients Failure Free at 2 Years Following Study Entry|Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.|Up to 2 years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2850963|NCT00068406|Primary|Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period|Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0|Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment|Eligible and treated patients|||Participants|||Count of Participants
2850964|NCT00068406|Primary|Complete Clinical and Pathologic Response|Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.|Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.|Eligible and treated patients|||Percentage of Participants||90% Confidence Interval|Number
2850965|NCT00068393|Secondary|Progression-free Survival|Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
2850966|NCT00068393|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
2850967|NCT00068393|Primary|Response Rate by Solid Tumor Response Criteria (RECIST)|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.|||Percentage of Participants||90% Confidence Interval|Number
2850968|NCT00068380|Primary|Baseline Gene Expression Levels of the Target Genes (PDGF-R and PDGF), Genes Associated With Induction of Apoptosis (Bcl-2, Bax), and Cell Cycle Regulatory Genes (p53, p21, p27|Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges - or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals. The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.|Baseline|Gene data were not collected. Due to budget constraints and recent reprioritizations, CTEP closed the study to accrual prior to collection of correlative data.||||||
2850969|NCT00068380|Primary|Time to Treatment Failure|Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From first day of treatment until discontinuation of treatment, assessed up to 30 days post treatment||||Months||95% Confidence Interval|Median
2850970|NCT00068380|Primary|Overall Survival|Will be summarized using the Kaplan-Meier product-limit estimators.|From first day of treatment to time of death due to any cause, assessed up to 5 years post-treatment||||Months||95% Confidence Interval|Median
2850971|NCT00068380|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment||||Months||95% Confidence Interval|Median
2850972|NCT00068380|Primary|Toxicity Summary|Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.|Up to 30 days post treatment||||Participants|||Count of Participants
2850973|NCT00068380|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 years||||percentage of patients responding|||Number
2850974|NCT00068367|Other Pre-specified|Feasibility of Accruing These Patients in the Cooperative Group Setting|NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY||||||||
2850975|NCT00068367|Other Pre-specified|Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.|NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY||||||||
2850976|NCT00068367|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 25 weeks|All participants receiving at least some protocol treatment|||Participants|||Number
2850977|NCT00068367|Primary|Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.|"Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values.~Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions."|25 weeks||||Participants|||Count of Participants
2850978|NCT00068341|Secondary|Pathologic Nodal Status|According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer|5 years|only 71 subjects of the 74 subjects could be analyzed for this outcome measure due to data collection error.|||participants|||Number
2850979|NCT00068341|Secondary|Clinico-histologic Predictors of pCR (Pathologic Complete Response)||5 years|ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), FISH (Fluorescence in situ hybridization), IDC (invasive ductal carcinoma), ILC (invasive lobular carcinoma),|||participants|||Number
2850980|NCT00068341|Secondary|Tumor Response Assessment|Measured by physical examination compared to breast mammography and MRI assessment|5 years|"pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for~1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]"|||participants|||Number
2850981|NCT00068341|Secondary|Clinical Tumor Response by Physical Exam and Imaging Studies||5 years|Clinical response was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]|||participants|||Number
2850982|NCT00068341|Primary|Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.|"Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).~Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen."|5 years|pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group [1 protocol violation, 1 bilateral disease] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group [protocol violation]|||participants|||Number
2850983|NCT00068250|Secondary|Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)|Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )|Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.|Eligible patients on Temozolomide 100 mg arms who started study treatment|||years||95% Confidence Interval|Median
2850984|NCT00068250|Secondary|Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)|Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )|From start of treatment to 10 weeks if RT received, to 15 weeks if not.|Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review|||Participants|||Count of Participants
2850985|NCT00068250|Primary|Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)|Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )|Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.|Eligible patients on Temozolomide 100 mg arms who started study treatment|||percentage of participants||95% Confidence Interval|Number
2850986|NCT00068250|Primary|Number of Phase I Participants Experiencing Toxicity|A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.|From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.|Eligible patients on Phase I arms who started study treatment|||Participants|||Count of Participants
2850987|NCT00068237|Secondary|Overall Survival Rate at 2 Years|Failure was defined as death due to any cause. Survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Survival rate is estimated using the kaplan-meier method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2850988|NCT00068237|Secondary|Disease-free Survival Rate at 2 Years|Failure was defined as local, regional, or distant recurrence/progression, second primary tumor, or death due to any cause. Disease-free survival time is defined as time from registration to the the date of failure or last known follow-up (censored). Disease-free survival rate is estimated using the kaplan-meier method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2850989|NCT00068237|Secondary|Percentage of Patients Experiencing Late Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy|"Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Late refers to toxicities occurring at least 91 days from the start of radiation therapy."|From 91 days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 5.6 years.|Eligible patients who started RT and had toxicity data at least 90 days from the end of RT|||percentage of participants||95% Confidence Interval|Number
2850990|NCT00068237|Secondary|Percentage of Patients Experiencing Acute Grade 3-4 Toxicity Definitely, Probably, or Possibly Related to Radiation Therapy or Chemotherapy|"Adverse events are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v2.0. Grade refers to the severity of the toxicity by assigning Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Acute refers to toxicities occurring less than or equal to 90 days from the start of radiation therapy."|From start of radiation therapy to 90 days|Eligible patients who started RT|||percentage of participants||95% Confidence Interval|Number
2850991|NCT00068237|Secondary|Percentage of Patients Experiencing Facial Edema Following Surgery|Facial edema was noted as present or absent following surgery.|From surgery to 30 days after surgery|Eligible patients who received the procedure|||percentage of participants||95% Confidence Interval|Number
2850992|NCT00068237|Secondary|Change From Baseline to One Year in Total Score on the Modified University of Washington Head and Neck Symptom Questionnaire|The University of Washington Head and Neck Symptom Questionnaire, also referred to as the University of Washington Health Related Quality of Life tool (UW-QOL) was modified for use by the Radiation Therapy Oncology Group (RTOG). The resulting UW-QOL-RTOG modification is a valid tool that can be used to assess symptom burden of head and neck cancer patients receiving radiation therapy or those who have recently completed radiation. The UW-QOL-RTOG modification consists of 15 items with response options ranging from 10-50, in multiples of 10. That is, the lowest symptom burden is rated as 10, while the highest symptom burden is rated as 50. The individual item scores are averaged to obtain the final score which also ranges from 10 to 50. This scoring results in a lower score indicating greater HR-QOL; and conversely, higher scores indicating lower health-related quality of life (HR-QOL). Change = baseline score - one year score, such that a positive change score indicates improvement.|Baseline and one year|Eligible patients with both baseline and 1-year questionnaire completed|||score on a scale||Inter-Quartile Range|Median
2850993|NCT00068237|Secondary|Percentage of Patients With Normal Functioning Transferred Submandibular Gland|"Salivary gland functioning classified as Non-functioning, Minimal function, Well-functioning but some impairment, Normal functioning, or Other is determined by central review of scintigraphy scans using sodium pertechnetate (Na-99mTcO4-) with a sialagogue (lemon juice) administered halfway through the study to determine if secretory function is maintained."|Pre-surgery, post-surgery (4-6 weeks), post radiation therapy (10-13 weeks)|Eligible patients with salivary scans submitted|||percentage of participants||95% Confidence Interval|Number
2850994|NCT00068237|Secondary|Percentage of Patients With Acute Xerostomia|The proportion of patients who experience grade 2 or higher xerostomia or start amifostine and/or pilocarpine within 90 days of the start of radiation therapy. A proportion less than or equal to 51% would be considered acceptable based on the results of the U.S. Bioscience phase III amifostine trial (this trial preceded FDAAA requirements).|From start of treatment to 90 days|Eligible patients who started RT|||percentage of participants||95% Confidence Interval|Number
2850995|NCT00068237|Primary|"Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed Per Protocol"|"Surgery will be scored as per protocol prescription if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery per protocol prescription, then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%."|At the time of the submandibular salivary gland transfer|Eligible patients who started study treatment.|||participants|||Number
2850996|NCT00068107|Secondary|Doppler Skin Blood Flow||10 years|Doppler skin blood flow was not collected in this study because it was judged to not be useful early in the study.||||||
2851013|NCT00067002|Primary|Time To Neutrophil Engraftment|Engraftment is defined as a sustained ANC > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) >/= 0.5 x 10^9/L.|First 100 days, evaluation and blood tests twice weekly||||Days||Full Range|Median
2850997|NCT00068107|Secondary|Quantitative Sensory Testing|"For quantitative sensory testing, the outcome variable (detection threshold score) was analyzed for all combinations of location (foot, hand, and thigh) and test (cold, vibration, and warm). Possible threshold scores may range from 1-25. Score values of >25 were set to 25. Higher scores indicate higher sensory detection threshold. Therefore, lower score is better. Time, measured in years, was centered at the date in which patients switched treatment regimen. All available measurements were used. A linear mixed model analysis was used to test for differences in the linear association between time and detection threshold score pre-and-post ERT regiment change while accounting for the correlation among observations from the same individual. Specifically, the model contained a subject specific random intercept with year as a fixed effect and knot at time of the treatment change."|pre-study was 2-4 years, during study sensory testing measured for approx. 4.5-5 years|Number of participants with a sufficient number of data points to estimate slope|||units on a scale/year||Standard Error|Mean
2850998|NCT00068107|Secondary|Number of Participants With a Change in Quantitative Sudomotor Axon Reflex Test|Quantitative sudomotor axon reflex test (QSART) is a measure of sweat function|Baseline and last observation (up to 10 years)||||participants|||Number
2850999|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Urine Sediment||Baseline and last observation (up to 10 years)||||nanomole/(gram of Creatinine)|||Number
2851000|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Plasma||Baseline and last observation (up to 10 years)||||nanomole/mL|||Number
2851001|NCT00068107|Primary|Estimated Glomerular Filtration Rate (eGFR)|The rate of decline in renal function, as measured by estimation of glomerular filtration rate at baseline when participants were receiving agalsidase alfa (Relagal) every 2 weeks and when participants were receiving weekly infusion of Relagal.|Relagal was administered every 2 weeks for 2-4 years pre-study, Relagal was administred weekly during the study (approx. 4.5-10 years)||||ml/min/month||Standard Deviation|Mean
2851002|NCT00067990|Secondary|Number of Participants With Cortical Interstitial Volume Expansion or Any ESRD|Number of subjects who had doubling of the interstitial or any end stage renal disease (ESRD) not attributed to interstitial fibrosis and tubular atrophy (IF/TA)|Baseline and 5 Years Post Transplant|Number of subjects who had baseline and exit biopsy samples that could be analyzed for doubling of cortical interstitial volume expansion or graft loss from IF/TA.|||Participants|||Count of Participants
2851003|NCT00067990|Primary|Doubling of Interstitium or Any ESRD|Doubling of the interstitial or any defined ESRD (including IF/TA)|Baseline to 5 years||||Participants|||Count of Participants
2851004|NCT00067808|Primary|Participant Responses|Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to >100 x 109/L; and 'No Response'.|Response to treatment after 8 weeks of therapy|As treated: 124 patients completed treatment.|||Participants|||Number
2851005|NCT00067470|Secondary|Change From Baseline in Urinary GAG (uGAG) at 24 Weeks|Glycosaminoglycan (GAG) level measured in urine|baseline and 24 weeks|Baseline uGAG level was measured for 19 rhASB-treated subjects and 20 placebo-treated subjects. However, uGAG levels at 24 weeks were measured for 19 rhASB-treated subjects and 19 placebo-treated subjects, because 1 placebo-treated subject withdrew from the study before week 24.|||micrograms per mg creatinine||Standard Deviation|Mean
2851006|NCT00067470|Secondary|Change From Baseline in 3-minute Stair Climb at 24 Weeks|Number of stairs climbed per minute in 3 minutes at 24 weeks minus number of stairs climbed per minute in 3 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placbo group who withdrew from the study prior to the week 24 assessment.|||stairs/min||Standard Deviation|Mean
2851007|NCT00067470|Primary|Change From Baseline in 12-minute Walk Test at 24 Weeks|Number of meters walked in 12 minutes at week 24 minus number of meters walked in 12 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placebo group who withdrew from the study prior to the week 24 assessment.|||meters||Standard Deviation|Mean
2851008|NCT00067236|Primary|Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)|Mean change of left ventricular end diastolic volume index (mL/m2) as evaluated via ventricular end-diastolic volume index augmentation 90 days post Myocardial Infarction (MI)|90 days|A patient was considered evaluable for the primary efficacy assessment if data were complete for at least the baseline and Day 90 visit (i.e., no data were imputed for the primary endpoint).|||mL/m2||Standard Error|Mean
2851009|NCT00067002|Secondary|Number of Participants Severity of Acute GVHD by Treatment Arm|The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. The stages of individual organ involvement is assessed using Glucksberg grade (I-IV) where Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.|Following first 100 days, up to one year|For the Acute GVHD the analysis was performed on patients with GVHD in the first 100 days.|||Participants|||Count of Participants
2851010|NCT00067002|Secondary|Rate of Chronic GVHD|Number of participants who present GVHD post-transplant and display features of chronic GVHD. Diagnostic and distinctive features of chronic GVHD are present. There are no features of acute GVHD.|Up to one year|Chronic GVHD percentage calculated using engrafted patients and alive after 100 days (n=77; expanded 40; unmanipulated 37)|||Participants|||Count of Participants
2851011|NCT00067002|Secondary|Rate of Acute Graft Versus Host Disease (GVHD)|Number of participants who display features of acute GVHD within 100 days of transplant.|Review over first 100 days|Acute GVHD percentage calculated using engrafted participants only (n=89; expanded 44; un-manipulated 45)|||Participants|||Count of Participants
2851012|NCT00067002|Primary|Number of Participants With Engraftment|Engraftment defined as a sustained absolute neutrophil count (ANC) > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC <500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination.|First 100 days, evaluation and blood tests twice weekly||||Participants|||Count of Participants
2851014|NCT00066963|Primary|Number of Caries Incident Cases|A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.|two years|intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.|||participants|||Number
2851015|NCT00066937|Secondary|Mental Health as Assessed by the Short Form 36 Healthy Survey|The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).|baseline, post-treatment, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
2851016|NCT00066937|Secondary|Worst Pain|0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week|baseline, post-treatment, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
2851017|NCT00066937|Primary|Change in Pain-related Interference|Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference|baseline, post-treatment, 3 months, 6 months||||Change in scores on a scale||Standard Deviation|Mean
2851018|NCT00066937|Primary|Average Pain|0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain|baseline, post-treatment, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
2851019|NCT00066807|Secondary|Sites of First Treatment Failure||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
2851020|NCT00066807|Secondary|Systemic Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
2851021|NCT00066807|Secondary|Overall Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
2851022|NCT00066807|Primary|Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.||||||
2851023|NCT00066781|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Time to disease progression will be calculated for all evaluable patients combined and by group (ie. for patients with or without the UGT1A1*28 polymorphism).|Up to 2 years||||Months||95% Confidence Interval|Median
2851024|NCT00066781|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due > to any cause. The distribution of survival time will be estimated using > the method of Kaplan-Meier . Overall survival will be calculated for > all evaluable patients combined and by group (ie. for patients with or > without the UGT1A1*28 polymorphism).|Up to 2 years||||Months||95% Confidence Interval|Median
2851025|NCT00066781|Primary|Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria|The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response.|Up to 2 years|All evaluable patients|||percentage of patients with response||95% Confidence Interval|Number
2851026|NCT00066742|Secondary|Progression-Free Survival|Progression was defined as a >= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.||||months||95% Confidence Interval|Median
2851027|NCT00066742|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.|A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis.|After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analysis.|||participants|||Number
2851028|NCT00066742|Primary|Overall Survival|Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.|Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analsysis.|||months||95% Confidence Interval|Median
2851029|NCT00066703|Secondary|Overall Survival|Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|8-year estimates, reported at a median follow-up of 9 years|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851030|NCT00066703|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up|5-year estimates reported at a median follow-up of 72 months|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851031|NCT00066703|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851032|NCT00066703|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851033|NCT00066690|Secondary|Overall Survival|Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|8-year estimates, reported at a median follow-up of 8 years|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851034|NCT00066690|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851035|NCT00066690|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851036|NCT00066690|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat|||percentage of participants||95% Confidence Interval|Number
2851037|NCT00066573|Secondary|Clinical Fracture Rate: Number of Participants With Bone Fractures.|Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.|8 years||||Participants|||Count of Participants
2851038|NCT00066573|Secondary|Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence|Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.|5 years|Intent to treat|||Participants|||Count of Participants
2851039|NCT00066573|Secondary|Overall Survival: Percentage of Participants Alive at 5 Years|Overall survival is defined as the time from randomization to the time of death from any cause.|5 years|Intend to treat|||Percentage of Participants||95% Confidence Interval|Number
2851040|NCT00066573|Primary|Event-free Survival|Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.|5 years||||percentage of participants||95% Confidence Interval|Number
2851041|NCT00066469|Primary|Event-free Survival|Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.|2 years|One patient out of the 55 patients enrolled was ineligible for study and therefore was excluded from analysis.|||percentage of participants analyzed||95% Confidence Interval|Number
2851042|NCT00066365|Primary|Feasibility Success|Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.|Enrollment through 21 days of protocol therapy|This outcome measure was calculated for eligible patients only. This yields 27 patients for assessment of this measure in Group 1 and 16 patients for assessment of this measure in Group 2.|||participants|||Number
2851043|NCT00066365|Primary|Event Free Survival (EFS)|EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.|Time of enrollment to Event or 5 years from enrollment, whichever occurs first|There were 4 ineligible unilateral patients and 2 ineligible bilateral patients not included in this analysis.|||years||95% Confidence Interval|Median
2851044|NCT00066365|Primary|Clusterin Status in Post Chemotherapy Sample||29 days after start of protocol therapy|This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.|||participants|||Number
2851176|NCT00064753|Primary|Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events||Up to 6 years (mean 4 years)|Censored at 3 months after return to dialysis|||participants|||Number
2851045|NCT00066365|Primary|Clusterin Status in Pre Chemotherapy Sample|The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.|||participants|||Number
2851046|NCT00066365|Primary|S100 Status in Post Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.|||participants|||Number
2851047|NCT00066365|Primary|S100 Status in Pre Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.|||participants|||Number
2851048|NCT00066365|Primary|CD1a Status in Post Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.|||participants|||Number
2851049|NCT00066365|Primary|CD1a Status in Pre Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.|||participants|||Number
2851050|NCT00066365|Primary|FAS Status in Post Chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.|||participants|||Number
2851051|NCT00066365|Primary|FAS Ligand in Post Chemotherapy Sample|FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.|||participants|||Number
2851052|NCT00066365|Primary|Presence of FAS in Pre-chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.|||participants|||Number
2851053|NCT00066365|Primary|Status of FAS Ligand in Pre-chemotherapy Sample|FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.|||participants|||Number
2851054|NCT00066222|Secondary|Tumor Response|Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From the start of treatment to 2 months following the completion of chemotherapy|Eligible patients who started study treatment and were observed for at least 2 months post-treatment|||Participants|||Count of Participants
2851055|NCT00066222|Secondary|Frequency of Treatment-related Fatalities at 2 Years|A treatment-related fatality was any death judged to be related to protocol treatment.|From the start of treatment to 2 years|Eligible patients who started study treatment|||Participants|||Count of Participants
2851056|NCT00066222|Secondary|Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis|Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to toxicity.|From start of radiation therapy until 90 days following the start of radiation therapy|Eligible patients who started study treatment|||Participants|||Count of Participants
2851073|NCT00065806|Secondary|Change in Mean-Mean Bifurcation CIMT|For the bifurcation arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right bifurcation near wall mean, right bifurcation far wall mean, left bifurcation near wall mean and left bifurcation far wall mean). These summary variables were then averaged to estimate a single mean-mean bifurcation CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851057|NCT00066222|Secondary|Median Overall Survival Time and Progression-free Survival Time|An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.|From registration to 2 years|All eligible patients who started study treatment|||months||95% Confidence Interval|Median
2851058|NCT00066222|Secondary|Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year|An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.|From registration to one year.|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2851059|NCT00066222|Primary|Overall Survival at 2 Years|Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 2 years|All eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
2851060|NCT00066170|Primary|Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.|Baseline to Week 8||||Minutes||Standard Deviation|Mean
2851061|NCT00066066|Primary|Change in Mean Clinical Attachment Level.|"Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a fixed landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases."|Baseline, 3, 6 and 12 months|Of the 146 subjects, 117 were included in the analysis, who had 2 or fewer missing monitoring visits. 84 subjects had complete data, 23 subjects had one missing visit and 10 subjects had 2 missing visits. For the 33 subjects with missing visits, data were carried forward. 68 subjects were non smokers and 49 subjects were current smokers.|||mm||Standard Error|Mean
2851062|NCT00065806|Secondary|Change in Homocysteine||Change from baseline to 36 months||||μmoles/liter||95% Confidence Interval|Mean
2851063|NCT00065806|Secondary|Change in Lipoprotein A||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
2851064|NCT00065806|Secondary|Change in Triglycerides||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
2851065|NCT00065806|Secondary|Change in LDL Cholesterol||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
2851066|NCT00065806|Secondary|Change in HDL Cholesterol||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
2851067|NCT00065806|Secondary|Change in Total Cholesterol||Change from baseline to 36 months||||mg/dl||95% Confidence Interval|Mean
2851068|NCT00065806|Secondary|Change in Natural Log of mg/L for hsCRP||Change from baseline to 36 months||||natural log of mg/L||95% Confidence Interval|Mean
2851069|NCT00065806|Secondary|Change in Mean-Mean Near Wall CIMT|For the near wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common near wall mean, right bifurcation near wall mean, right internal near wall mean, left common near wall mean, left bifurcation wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851070|NCT00065806|Secondary|Change in Mean-Max Near Wall CIMT|For the near wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common near wall max, right bifurcation near wall max, right internal near wall max, left common near wall max, left bifurcation near wall max, and left internal near wall max). These 6 summary variables were then averaged to estimate a single mean-max near wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851071|NCT00065806|Secondary|Change in Mean-Mean Far Wall CIMT|For the far wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common far wall mean, right bifurcation far wall mean, right internal far wall mean, left common far wall mean, left bifurcation far wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851072|NCT00065806|Secondary|Change in Mean-Max Far Wall CIMT|For the far wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common far wall max, right bifurcation far wall max, right internal far wall max, left common far wall max, left bifurcation far wall max, and left internal far wall max). These 6 summary variables were then averaged to estimate a single mean-max far wall CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851121|NCT00065468|Secondary|Progression-Free Survival (PFS)|PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.|Baseline, monthly until tumor progression or death (up to Month 80)|ITT|||months||95% Confidence Interval|Median
2851074|NCT00065806|Secondary|Change in Mean-Max Bifurcation CIMT|For each side and wall of the bifurcation arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right bifurcation near wall max, right bifurcation far wall max, left bifurcation near wall max and left bifurcation far wall max). These summary variables were then averaged to estimate a single mean-max bifurcation CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851075|NCT00065806|Secondary|Change in Mean-Mean Internal CIMT|For the internal carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right internal near wall mean, right internal far wall mean, left internal near wall mean and left internal far wall mean). These summary variables were then averaged to estimate a single mean-mean internal CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851076|NCT00065806|Secondary|Change in Mean-Max Internal CIMT|For each side and wall of the internal carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right internal near wall max, right internal far wall max, left internal near wall max and left internal far wall max). These summary variables were then averaged to estimate a single mean-max internal CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851077|NCT00065806|Secondary|Change in Mean-Max Common CIMT|For each side and wall of the common carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right common near wall max, right common far wall max, left common near wall max and left common far wall max). These summary variables were then averaged to estimate a single mean-max common CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851078|NCT00065806|Secondary|Change in Mean-Mean CIMT|For each side, segment and wall, mean CIMT values were averaged over the 4 angles of interrogation to produce 12 summary variables (right common near wall mean, right common far wall mean, right bifurcation near wall mean, right bifurcation far wall mean, right internal near wall mean, right internal far wall mean, left common near wall mean, left common far wall mean, left bifurcation near wall mean, left bifurcation far wall mean, left internal near wall mean and left internal far wall mean). These 12 summary variables were then averaged to estimate a single mean-mean CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851079|NCT00065806|Secondary|Change in Mean-Max CIMT|For each side, segment and wall, the maximum CIMT over the 4 angles of interrogation was selected to produce 12 summary variables (right common near wall max, right common far wall max, right bifurcation near wall max, right bifurcation far wall max, right internal near wall max, right internal far wall max, left common near wall max, left common far wall max, left bifurcation near wall max, left bifurcation far wall max, left internal near wall max and left internal far wall max). These 12 summary variables were then averaged to estimate a single mean-max CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851080|NCT00065806|Primary|Change in Mean-Mean Common Carotid IMT (CIMT)|For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit.|Change from baseline to 36 months||||mm||95% Confidence Interval|Mean
2851081|NCT00014560|Secondary|Serum Markers of Macrophage Activation|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24|||||||
2851082|NCT00014560|Primary|Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1-29|||||||
2851083|NCT00014560|Primary|Clinical Toxicity|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|day 1-29|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).||||||
2851084|NCT00065611|Secondary|CKD-EPI eGFR|Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.|48 weeks from baseline||||ml/min/1.73m^2||Standard Deviation|Mean
2851085|NCT00065611|Secondary|Urine Protein||48 weeks from baseline||||g/d||Standard Deviation|Mean
2851086|NCT00065611|Primary|Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks|Complete remission is defined as proteinuria <0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria <3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as >60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.|48 weeks from baseline|ITT|||participants|||Number
2851087|NCT00065507|Secondary|Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up||On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.|||participants|||Number
2851088|NCT00065507|Secondary|Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period|Data includes type of malignant neoplasm.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.|||participants|||Number
2851089|NCT00065507|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment|ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date.|Treated participants - as treated. The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.|||participants|||Number
2851090|NCT00065507|Secondary|Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data|Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.|Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received).|||participants|||Number
2851091|NCT00065507|Secondary|Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures.|on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received). Note that 5 additional enrolled participants died prior to initiation of treatment and are not included in this table.|||participants|||Number
2851092|NCT00065507|Secondary|Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48|HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points.|Week 48|Treated, through Week 48 - (analyzed as-treated). (Week 48 on-treatment safety data contain all on-treatment data up to study Day 336, if the subject is still on treatment. If the subject discontinued before study Day 336, then all data up to 5 days after the discontinuation date were included.) n=number of participants at risk at each timepoint.|||HCC events|||Number
2851093|NCT00065507|Secondary|Participants Achieving Platelet Count Normalization Through Week 48|Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.|||participants|||Number
2851094|NCT00065507|Secondary|Participants Achieving Total Bilirubin Normalization Through Week 48|Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.|||participants|||Number
2851095|NCT00065507|Secondary|Participants Achieving Prothrombin Time Normalization Through Week 48|Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.|||participants|||Number
2851096|NCT00065507|Secondary|Participants Achieving Albumin Normalization Through Week 48|Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects (as randomized). Excludes subjects with normal albumin at Baseline. Non-completer = failure.|||participants|||Number
2851097|NCT00065507|Secondary|Change From Baseline in Platelet Count Through Week 48|Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.|||10*9 c/L||Standard Error|Mean
2851098|NCT00065507|Secondary|Mean Change From Baseline in Total Bilirubin Through Week 48|Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.|||mg/dL||Standard Error|Mean
2851099|NCT00065507|Secondary|Mean Change From Baseline in Prothrombin Time Through Week 48|Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.|||seconds||Standard Error|Mean
2851240|NCT00063882|Secondary|Change in Health-Related Quality of Life From Baseline to 24-Months as Measured by EQ-5D and AUA-SI||Baseline and 24 months after start of radiation||2021-12-31|12/2021||||
2851100|NCT00065507|Secondary|Change From Baseline in Albumin Through Week 48|Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as randomized; n=number of participants with value at baseline and given timepoint.|||g/dL||Standard Error|Mean
2851101|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48|The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.||||||
2851102|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36)|Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.||||||
2851103|NCT00065507|Secondary|Improvement or No Worsening in MELD Score Through Week 48|Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.|||Participants|||Number
2851104|NCT00065507|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48|Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as-randomized populations; n=number of participants with assessment at baseline and timepoint. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are obtained after the start of therapy and <=5 days after the last dose of study therapy.|||units on a scale||Standard Error|Mean
2851105|NCT00065507|Secondary|Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48|Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C.|Week 24, Week 48|Treated participants (as-randomized). The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|||Participants|||Number
2851106|NCT00065507|Secondary|Change From Baseline in Child-Pugh Score Through Week 48|Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.|||units on a scale||Standard Error|Mean
2851107|NCT00065507|Secondary|Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48|Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated participants (as-randomized). Non-completer=Failure. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|||Participants|||Number
2851122|NCT00065468|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to Month 80|Intent-to-treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
2851123|NCT00065442|Secondary|Time to Objective Disease Progression|Measured by imaging studies; confirmed by independent imaging review|Analysis conducted at the time of overall survival analysis||||Weeks||95% Confidence Interval|Median
2851108|NCT00065507|Secondary|>=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48|Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects-As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after start of therapy and <=5 days after the last dose of study therapy.) Non-completer=Failure. n=number of participants with measurement at baseline and timepoint.|||Participants|||Number
2851109|NCT00065507|Secondary|Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48||Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.|||Participants|||Number
2851110|NCT00065507|Secondary|Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48|Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48|Week 24, Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).Participants in each group who achieved ALT normalization among those with baseline ALT >1.0 x ULN.|||Participants|||Number
2851111|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48||Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).|||Participants|||Number
2851112|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24||Week 24|Treated Subjects - As-Randomized population, responders only (non-completer=failure).|||participants|||Number
2851113|NCT00065507|Secondary|Change From Baseline in HBV DNA by PCR at Week 48|Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status.|Baseline, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 48 analysis window.|||log10 copies/mL||Standard Error|Mean
2851114|NCT00065507|Primary|Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24|Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.|Baseline, Week 24|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 24 analysis window.|||log10 copies/mL||Standard Error|Mean
2851115|NCT00065468|Secondary|European Quality of Life Health Questionnaire (EQ-5D) - Index Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.|Baseline|ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.|||units on a scale||Full Range|Median
2851116|NCT00065468|Secondary|Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)|"The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the dispersion of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed."|Baseline to Month 80|ITT|||months|||Number
2851117|NCT00065468|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.|Baseline, every month until tumor progression or death (up to Month 80)|ITT|||months||95% Confidence Interval|Median
2851118|NCT00065468|Secondary|Duration of Response (DR)|DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.|Baseline, every month until tumor progression or death (up to Month 80)|ITT subset of participants who had a response|||months||95% Confidence Interval|Median
2851119|NCT00065468|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT|||percentage of participants||95% Confidence Interval|Number
2851120|NCT00065468|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT|||percentage of participants||95% Confidence Interval|Number
2851124|NCT00065442|Primary|Overall Survival|Time from randomization until death due to any cause.|Event-driven timeframe. Final analysis at 331 events.||||Months||95% Confidence Interval|Median
2851125|NCT00065429|Primary|Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]|Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions|6 weeks|All patients with a baseline and follow up imaging scan were evaluated. Data represents information following the first cycle of treatment.|||participants|||Number
2851126|NCT00065429|Primary|Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)|Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.|every 6 weeks|All Phase I enrolled patients who received study drug were analyzed for DLTs.|||participants|||Number
2851127|NCT00065260|Secondary|Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia||months/years|||||||
2851128|NCT00065260|Primary|No Longer Meeting Criteria for Severe Aplastic Anemia.||6 months||||participants|||Number
2851129|NCT00065182|Secondary|Number of Participants With Clinically Significant Abnormal Vital Signs Data|Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.|Up to 16 months|mITT population.|||Participants|||Count of Participants
2851130|NCT00065182|Secondary|Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities|Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.|Up to 16 months|mITT population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2851131|NCT00065182|Secondary|Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities|Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.|Up to 16 months|mITT population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2851132|NCT00065182|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.|Up to 16 months|mITT Population was defined as all participants who were randomized and received at least one dose of study medication.|||Participants|||Count of Participants
2851133|NCT00065182|Secondary|Assessment of Quality of Life-assessed Every 4 Weeks|The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).|Every 4 Weeks post randomization|ITT population. Data was not collected for this outcome measure.||||||
2851134|NCT00065182|Secondary|Time to Response-assessed Every 8 Weeks|Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.|Every 8 Weeks post randomization|ITT population. Data was not collected for this outcome measure.||||||
2851135|NCT00065182|Secondary|Response Duration|Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.|Up to one year from Day -1 (randomization)|ITT population. Data was not collected for this outcome measure.||||||
2851136|NCT00065182|Secondary|Response Rate|Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.|Up to one year from Day -1 (randomization)|ITT population. Data was not collected for this outcome measure.||||||
2851137|NCT00065182|Secondary|Median Time to Progression|Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.|Up to one year from Day -1 (randomization)|ITT population. Data was not collected for this outcome measure.||||||
2851138|NCT00065182|Secondary|Number of Participants With One-year Survival|Number of participants with one-year survival were planned to be reported.|Up to one year from Day -1 (randomization)|ITT population. Data was not collected for this outcome measure.||||||
2851139|NCT00065182|Primary|Median Time of Overall Survival|Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.|Up to one year from Day -1 (randomization)|Intent-to-treat (ITT) population was defined as all participants randomized to one of the two treatment regimens.|||Weeks||95% Confidence Interval|Median
2851140|NCT00065156|Secondary|Participants With Bone Marrow Progression|"Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):~Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).~Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML)."|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.|||participants|||Number
2851141|NCT00065156|Secondary|Participants With Complete or Partial Bone Marrow Improvement|Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist.|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.|||participants|||Number
2851142|NCT00065156|Secondary|Participant Counts of Absolute Neutrophil Count (ANC) Response|"Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of~≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) <1 * 10^9/L.|||participant|||Number
2851143|NCT00065156|Secondary|Participant Counts of Platelet Response|"Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.~Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions."|up to 2 years|Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count <100 * 10^9/L to be included in the analysis.|||participants|||Number
2851144|NCT00065156|Secondary|Participant Counts of Cytogenetic Response|"Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least~1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits.|||participants|||Number
2851145|NCT00065156|Secondary|Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders|The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline.|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|Modified intent to treat population who achieved transfusion independence|||g/dL||Standard Deviation|Mean
2851146|NCT00065156|Secondary|Kaplan Meier Estimate for Duration of Transfusion Independence Response|Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence.|up to 2 years|Modified intent to treat population who achieved transfusion independence|||weeks||95% Confidence Interval|Median
2851147|NCT00065156|Secondary|Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study|"Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study."|up to 2 years|Modified intent to treat population who achieved transfusion independence|||participants|||Number
2851148|NCT00065156|Secondary|Time to Transfusion Independence|"Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period."|up to 2 years|Modified intent to treat population who achieved transfusion independence|||weeks||Standard Deviation|Mean
2851173|NCT00064753|Secondary|Fatal/Non-fatal Myocardial Infarction (MI)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851174|NCT00064753|Secondary|Mortality (All-cause)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851175|NCT00064753|Secondary|Renal Graft Failure||Up to 6 years (mean 4 years)|Intention-to-treat|||participants|||Number
2851149|NCT00065156|Secondary|Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study|A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment).|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|"Modified Intent to Treat (MITT)~diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation~received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period~received ≥1 dose of study drug"|||participant|||Number
2851150|NCT00065156|Secondary|Participants With Adverse Experiences|"Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|Up to 2 Years|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
2851151|NCT00065156|Primary|Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence|"Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin."|Up to 2 years|"Modified Intent to Treat (MITT)~diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation~received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period~received ≥1 dose of study drug"|||participants|||Number
2851152|NCT00065065|Secondary|Number of Participants With Endoscopic Remission at 12 Weeks||12 weeks||||Participants|||Count of Participants
2851153|NCT00065065|Secondary|Number of Participants With Clinical Remission at 12 Weeks|Mayo Score <=2 at 12 weeks post intervention|12 weeks||||participants|||Number
2851154|NCT00065065|Primary|Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks|Mayo score decrease >=2 points adjusted for age and smoking status.|12 weeks||||participants|||Number
2851155|NCT00003895|Primary|T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide|"Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients' immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods.~Pre- and post-immunization T-cell immunity to g209-2M peptide, to HPV16E7 peptide, and to a negative control HLA-A2 HIV peptide (pol) were assessed using HLA-A2/peptide tetramer-specific binding analysis. Within-subject analyses were performed to determine differences between pre- and postimmunization responses to the g209 -2M and HPV peptides and to the negative control HIV peptide after completion of 6 months of vaccination. Pre- versus postimmunization response differences were used as criterion measures in between-group (among subjects) analyses."|Baseline to 6 months|Patients were randomly assigned to two different vaccination schedules: group A received vaccinations every 2 weeks for 6 months (13 total injections), and group B received vaccinations every 3 weeks for 6 months (nine total vaccinations).|||% of CD8+ T cells||90% Confidence Interval|Mean
2851156|NCT00064987|Secondary|Fertility|Participants actively seeking to conceive.|24 months|Four subjects in Group 1 and two subjects in Group 2 were actively trying to conceive. Fertility was not tracked in subjects not trying to conceive.|||Participants|||Count of Participants
2851157|NCT00064987|Primary|Sperm Count|Average sperm count after treatment.|month 4 of GnRH treatment||||10^6 sperms/mL||Standard Deviation|Mean
2851158|NCT00064987|Primary|Testicular Size (Volume)|Average testicular volume after treatment.|at baseline and month 4 of GnRH treatment||||mL||Standard Deviation|Mean
2851159|NCT00064987|Primary|Inhibin B|Average Inhibin B Levels after treatment.|month 4 of GnRH treatment||||pg/mL||Standard Deviation|Mean
2851160|NCT00064987|Primary|Testosterone|Average Testosterone levels after treatment.|month 4 of GnRH treatment||||ng/dL||Standard Deviation|Mean
2851161|NCT00064987|Primary|FSH|Average Follicle Stimulating Hormone levels after treatment.|month 4 of GnRH treatment||||IU/L||Standard Deviation|Mean
2851162|NCT00064987|Primary|LH|Average Luteinizing Hormone levels after treatment.|month 4 of GnRH treatment||||IU/L||Standard Deviation|Mean
2851163|NCT00064844|Primary|12 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|12 months after smoking quit date||||percentage of participants abstinent|||Number
2851164|NCT00064844|Primary|6 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|6 months after smoking quit date||||percentage of participants abstinent|||Number
2851165|NCT00064753|Secondary|Renal Artery Revascularization|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851166|NCT00064753|Secondary|Abdominal Aortic Aneurysm Repair|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851167|NCT00064753|Secondary|Carotid Endarterectomy or Angioplasty|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851168|NCT00064753|Secondary|Lower Extremity Peripheral Arterial Disease (PAD)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851169|NCT00064753|Secondary|Coronary Artery Revascularization|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851170|NCT00064753|Secondary|CVD Death|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)|P was calculated with stratified proportional hazards models stratified by country|||participants|||Number
2851171|NCT00064753|Secondary|Resuscitated Sudden Death (RSD)|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851172|NCT00064753|Secondary|Fatal/Non-fatal Stroke|censored at 3 months after return to dialysis|Up to 6 years (mean 4 years)||||participants|||Number
2851177|NCT00003645|Other Pre-specified|Markers of Prognosis|To obtain blood/tissue samples from patients at high risk for failure post prostatectomy to evaluate markers of prognosis.|1 year after treatment|Due to poor study accrual there were not enough data collected to be analyzed to determine the markers of prognosis.||||||
2851178|NCT00003645|Other Pre-specified|Quality of Life for Participants|To determine the impact of one year of total androgen ablation on quality of life mentally, physically and sexual function. The following questionnaires were completed by patients in the clinic setting and used to assess HRQoL: Medical Outcomes Study 36-Item Short Form (SF-36) and University of California-Los Angeles Sexual Function Scale (UCLA-SFS). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life.|1 year||||score on a scale||95% Confidence Interval|Mean
2851179|NCT00003645|Other Pre-specified|"Number of Wives of the Participants Having Better Than or Equal to a Good Quality of Life"|To measure the differences in quality of life between wives of participants in the androgen ablation condition compared to wives of patients in the control condition by using quality of life assessments. The following questionnaires were completed in the clinic setting and used to assess Health related (HRQoL): Medical Outcomes Study 36‐Item Short Form (SF‐36), University of California‐Los Angeles Sexual Function Scale (UCLA‐SFS), and Southwest Oncology Group Treatment‐Specific Symptoms Scale (SWOG‐TSSS). The SF‐36 was analysed using a composite score for each of physical health and mental health. SF-36, UCLA-SFS, SWOGTSSS were combined to classify participants' quality of life.|2 years||||Participants|||Count of Participants
2851180|NCT00003645|Primary|Number of Participants With Disease Free Survival at 5 Years|To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.|Beginning of the study up to 5 years|The study terminated early without any participants reaching the 5 years on study analysis point.||||||
2851181|NCT00064792|Secondary|Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio|Percent of 7-dehydrocholesterol + 8-dehydrocholesterol as a fraction of the total sterols (cholesterol + 7-dehydrocholesterol + 8-dehydrocholesterol measured in cerebral spinal fluid|12 months||||percent of total sterols||Standard Deviation|Mean
2851182|NCT00064792|Primary|Serum Cholesterol to Total Sterol Ratio|Total serum cholesterol (mg/dL) divided by the sum of all sterols (cholesterol plus its precursors, 7-dehydrocholesterol - 7DHC, and 8-dehydrocholesterol- 8DHC - in mg/dL).|1 year after therapy.|The number of participants was determined by the total number of participants to complete both phases of the trial (n=18).|||percent total cholesterol||Standard Deviation|Mean
2851183|NCT00064701|Secondary|Kaplan-Meier Estimate of Graft Survival at the End of the Study|"Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was any retransplant or the permanent return to dialysis (more than 30 days) or patient death.~Graft survival was censored at the time of last follow-up contact."|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.|||percentage of participants||95% Confidence Interval|Number
2851184|NCT00064701|Secondary|Kaplan-Meier Estimate of Patient Survival at the End of the Study|Patient survival was defined as any participant who was alive at the end of the study. Patient survival was censored at the time of last follow-up contact.|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.|||percentage of participants||95% Confidence Interval|Number
2851185|NCT00064701|Secondary|Change From Month 1 in Creatinine Clearance at Month 6 and Month 12|Renal function was assessed by creatinine clearance, calculated using the Cockcroft-Gault formula.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.|||mL/min||Standard Deviation|Mean
2851186|NCT00064701|Secondary|Change From Month 1 in Serum Creatinine at Month 6 and Month 12|Renal function was assessed by the change from Month 1 in serum creatinine six months and 12 months after transplant.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.|||mg/dL||Standard Deviation|Mean
2851187|NCT00064701|Secondary|Number of Participants Who Crossed Over Due to Treatment Failure|Participants were allowed to cross over to an alternative primary immunosuppressive regimen (either to the tacrolimus or cyclosporine treatment arms) to address an adverse event which led to randomized study drug discontinuation or in the case of severe or refractory rejection. Crossover to the modified release tacrolimus treatment arm was not permitted.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
2851188|NCT00064701|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
2851189|NCT00064701|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
2851190|NCT00064701|Secondary|Number of Participants Experiencing Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
2851191|NCT00064701|Secondary|Severity of Acute Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising >25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set with a biopsy-confirmed acute rejection episode during one year.|||participants|||Number
2851192|NCT00064701|Secondary|Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice.~Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set.|||participants|||Number
2851193|NCT00064701|Secondary|Time to First Biopsy-confirmed Acute Rejection Episode|"Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~Acute rejection is defined as a grade ≥ I."|one year|The number of participants analyzed represents the full analysis set.|||days||Full Range|Median
2851194|NCT00064701|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~Acute rejection is defined as a grade ≥ I."|Six months and 12 months|The number of participants analyzed represents the full analysis set.|||percentage of participants|||Number
2851195|NCT00064701|Secondary|Graft Survival at One Year|"Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (> 30 days), patient death, or participant whose outcome at one year was unknown.~Participants were only counted once regardless of how many criteria were met."|One year|The number of participants analyzed represents the full analysis set.|||percentage of participants|||Number
2851196|NCT00064701|Secondary|Patient Survival at One Year|Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors.|One year|The number of participants analyzed represents the full analysis set.|||percentage of participants|||Number
2851197|NCT00064701|Primary|Percentage of Participants With Efficacy Failure|"Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis [> 30 days] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up.~Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set, defined as all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
2851198|NCT00064662|Primary|24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)|Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis|||% stress-specific success at 24 m||95% Confidence Interval|Number
2851199|NCT00064662|Primary|24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).|Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, <15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis.|||% success at 24 months||95% Confidence Interval|Number
2851200|NCT00064350|Secondary|Best Overall Response|The best overall response is the best response (per RECIST 1.0) recorded from randomization until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since randomization.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years||||Participants|||Number
2851201|NCT00064350|Secondary|Overall Survival|Overall survival is defined as the duration from randomization to death or last known alive. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years||||Months||95% Confidence Interval|Median
2851202|NCT00064350|Secondary|Progression-free Survival|Progression-free survival is defined as the duration from randomization to disease progression or death, whichever occurs first. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years.||||Months||95% Confidence Interval|Median
2851241|NCT00063882|Secondary|Change in Health-related Quality of Life From Baseline to 4-Months as Measured by EQ-5D (European Quality of Life-5 Domains) and AUA-SI (American Urological Association-Symptom Index)||Baseline and 4 months after start of radiation||2021-12-31|12/2021||||
2851203|NCT00064350|Primary|Number of Patients Maintaining Stable Disease or Objective Response 2 Months After Randomization|"Per RECIST Criteria (V1.0):~Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): >=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|Two months after randomization||||participants|||Number
2851204|NCT00064337|Secondary|Hematologic Response||Until off study||||Participants|||Count of Participants
2851205|NCT00064337|Primary|Overall Survival|Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.|5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years|Eligible and analyzable patients only.|||Months||95% Confidence Interval|Median
2851206|NCT00064298|Secondary|Cell Proliferation (Ki-67) at Baseline and Week 12|Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.|baseline and 12 weeks|All participants randomized. Not all participants had p27 or Ki67 data so the sample sizes for the primary and secondary analyses differ from the overall sample size.|||percentage of cells||Standard Error|Mean
2851207|NCT00064298|Primary|Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12|Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.|baseline and 12 weeks|All randomized participants. Not all participants had p27 or Ki67 determined, so the sample sizes for the two outcomes differ from the total sample size.|||percentage of cells||Standard Error|Mean
2851208|NCT00064259|Secondary|Microarray Data|This will be primarily descriptive, and will seek to compare patterns of gene expression pre- and post-treatment.|Up to 12 weeks|||||||
2851209|NCT00064259|Primary|Maximum Tolerated Dose (MTD) of Oblimersen in Combination With Cisplatin and 5-FU|Adverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria (version 2.0). DLT was defined as grade 3 to 4 hematologic toxicity lasting more than 1 week after 5-FU/cisplatin, grade 3 to 4 nausea or vomiting occurring later than 11 days after cisplatin, grade 3 to 4 diarrhea occurring later than 10 days after 5-FU, and grade 3 to 4 mucositis at the beginning of the next cycle.|21 days||||mg/kg/d|||Number
2851210|NCT00064077|Secondary|Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).|The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.|Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1|Patients who provided baseline and ≥ one follow-up assessments|||units on a scale||Standard Deviation|Mean
2851211|NCT00064077|Secondary|Pain, Assessed by Brief Pain Inventory|"Single item from the Brief Pain Inventory (BPI) assessing worst pain in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score."|Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1|Patients who provided baseline and ≥ one follow-up assessments|||units on a scale||Standard Deviation|Mean
2851212|NCT00064077|Secondary|Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)|The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.|Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1|Patients who provided baseline and ≥ one follow-up assessments|||units on a scale||Standard Deviation|Mean
2851213|NCT00064077|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)|Evaluable (treatment)|||months||95% Confidence Interval|Median
2851214|NCT00064077|Secondary|Frequency of Response Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.|Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)|Evaluable (treatment)|||Participants|||Count of Participants
2851215|NCT00064077|Primary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)|Evaluable (treatment)|||months||95% Confidence Interval|Median
2851216|NCT00064038|Primary|Progression-Free Survival|"Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.~In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs."|From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years||||percentage of participants||95% Confidence Interval|Number
2851217|NCT00064038|Secondary|Toxicity|Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.|From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years|All participants receiving at least one dose of induction therapy|||Participants|||Number
2851218|NCT00064025|Secondary|Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy , which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)|||Aggregate Score from Immunohistochemistr||Standard Error|Mean
2851219|NCT00064025|Secondary|Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)|||Aggregate Score from Immunohistochemistr||Standard Error|Mean
2851220|NCT00064025|Primary|Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative|"To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.~PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area."|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data)|||percentage of participants|||Number
2851221|NCT00063999|Secondary|Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection|Maximum grade of physician assessed neurotoxicity and infection|Assessed throughout the treatment period and for 30 days after discontinuation of treatment.|Eligible and treated patients|||Participants|||Count of Participants
2851222|NCT00063999|Secondary|Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)|The time alive in months from study entry to last contact or death.|Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.|Eligible patients with estrogen and progesterone receptor data.|||Participants|||Count of Participants
2851223|NCT00063999|Secondary|Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G|The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.|Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment|Eligible and evaluable and enrolled prior to 3/26/2006|||units on a scale||Standard Error|Least Squares Mean
2851250|NCT00063882|Secondary|Biochemical Failure (Phoenix Definition)|Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years.|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851224|NCT00063999|Secondary|Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)|The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).|Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start|Eligible and evaluable and enrolled prior to 3/26/2006|||units on a scale||Standard Error|Least Squares Mean
2851225|NCT00063999|Primary|Number of Participants Alive at Time of Last Follow-up.|The time alive in months from study entry to last contact or death.|Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.|Eligible and treated patients. Data are reported from the second interim analysis.|||Participants|||Count of Participants
2851226|NCT00063986|Secondary|Rate of Conversion to Open Operation After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.|Assessed at surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2851227|NCT00063986|Secondary|30-day Peri-operative Mortality After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.|Assessed at 30 days after surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
2851228|NCT00063986|Secondary|3-year Survival Rate|Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.|Assessed at 3 years|Eligible and treated patients are included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2851229|NCT00063986|Secondary|Total Number of Lymph Nodes Dissected|The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients.|||Lymph nodes||Full Range|Median
2851230|NCT00063986|Secondary|Overall Length of Hospital Stay|The number of days patients stayed in the hospital after surgery is reported.|Assessed after surgery until patients are out of hospital|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients.|||Days||Full Range|Median
2851231|NCT00063986|Secondary|Duration of Intensive Care Stay|Number of post-operative days in intensive care is reported.|Assessed after surgery until patients are out of intensive care|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients.|||Days||Full Range|Median
2851232|NCT00063986|Secondary|Duration of Operating Time|The length of the operation (total of thoracic and abdominal components) is recorded.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients.|||Minutes||Full Range|Median
2851233|NCT00063986|Secondary|Rate of Conversion to Open Operation|Proportion of patients who required conversion to operation will be reported.|Assessed at surgery|Eligible and treated patients are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2851234|NCT00063986|Primary|Peri-operative Mortality at 30 Days|The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.|Assessed at 30 days from surgery|Eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2851235|NCT00063934|Secondary|Bcl-2 Expression in Breast Cancer Tissue|Number of participant with Bcl-2 Expression in breast cancer tissue by protein and mRNA expression before treatment and at 3-5 days after oblimersen treatment.|before treatment and at 3-5 days after oblimersen treatment||||participants|||Number
2851236|NCT00063934|Secondary|Clinical Imaging Responses|Evaluation target lesions (clinical response) by physical exam/ultrasound measurements of primary tumor and axillary lymph nodes after 3-6 courses: Complete Response: Disappearance of all target lesions; Partial Response: >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1>new lesions; Stable Disease: Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum LD since treatment started.|After 3 and 6 courses of 21 day treatments (up to 18 weeks)||||participants|||Number
2851237|NCT00063934|Primary|Number of Participants With Pathologic Complete Response (pCR)|Pathologic complete responses (pCR), defined as no evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes, measured by microscopic evaluation of tissue specimen at time of definitive surgery (after 6 courses of neoadjuvant therapy). Neoadjuvant (preoperative) therapy administered on the first five days of every 3-week cycle. Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]|At time of definitive surgery (after 6 courses of neoadjuvant therapy in 3 week cycles), approximately 18 weeks|Intention to treat eligible participants per protocol.|||Participants|||Number
2851238|NCT00063934|Primary|Number of Participant With Toxicities||From baseline until the date of first documented toxicity or date of death from any cause, whichever came first, assessed every three weeks up to 2 years and 5 months||||Participants|||Count of Participants
2851239|NCT00063882|Other Pre-specified|Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy||Analysis occurs after all patients have been potentially followed for 5 years.|The pilot portion of the trial determined that the data required for this analysis was not able to be obtained, and therefore, there are no results for this outcome measure.||||||
2851242|NCT00063882|Secondary|Change in Health-Related Quality of Life From Baseline to 24-Months as Measured by EPIC|The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months.|Baseline and 24 months after start of radiation|Eligible patients with baseline and 24-month EPIC data|||units on a scale||Standard Deviation|Mean
2851243|NCT00063882|Secondary|Change in Health-related Quality of Life From Baseline to 4-Months as Measured by Expanded Prostate Cancer Index Composite (EPIC)|The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months.|Baseline and 4 months after start of radiation|Eligible patients with baseline and 4-month EPIC data|||units on a scale||Standard Deviation|Mean
2851244|NCT00063882|Secondary|Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]|Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring > 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported.|From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years.|Eligible patients who started study treatment and had follow-up data > 180 days from the start of treatment|||percentage of participants||95% Confidence Interval|Number
2851245|NCT00063882|Secondary|Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]|Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to based.|Zero to 180 days from the start of radiation|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2851246|NCT00063882|Secondary|Overall Survival|Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported.|From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years.|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851247|NCT00063882|Secondary|Distant Metastases|Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851248|NCT00063882|Secondary|Local Failure|Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851249|NCT00063882|Secondary|Prostate Cancer Death|Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851251|NCT00063882|Secondary|Biochemical Failure Rate (Protocol Definition)|Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851252|NCT00063882|Primary|5-Year Freedom From Progression Rate|A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.|From randomization to 5 years|All Eligible Patients|||percentage of participants||95% Confidence Interval|Number
2851253|NCT00063635|Secondary|Change in QOL- Psychosocial Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks||||units on a scale||95% Confidence Interval|Mean
2851254|NCT00063635|Secondary|Change in Quality of Life (QOL) Scores- Physical Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks||||units on a scale||95% Confidence Interval|Mean
2851255|NCT00063635|Secondary|Change in Serum Vitamin E Levels|Change in alpha-Tocopherol|baseline and 96 weeks||||mg/L||95% Confidence Interval|Mean
2851256|NCT00063635|Secondary|Change in Body Mass Index||baseline and 96 weeks||||kg/m-squared||95% Confidence Interval|Mean
2851257|NCT00063635|Secondary|Number of Participants With Improvement in Ballooning Degradation Score|Ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe ballooning. This secondary outcome measure is the number of participants that experienced a decrease in ballooning score at 96 weeks compared to baseline, which indicates improvement in ballooning.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
2851258|NCT00063635|Secondary|Number of Participants With Improvement in Lobular Inflammation Score|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score at 96 weeks compared to baseline, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
2851259|NCT00063635|Secondary|Number of Participants With Improvement in Steatosis Score|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score at 96 weeks compared to baseline, which indicates improvement in steatosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
2851260|NCT00063635|Secondary|Number of Participants With Improvement in Liver Fibrosis Score|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score at 96 weeks compared to baseline, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||participants|||Number
2851261|NCT00063635|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment|Histological activity was assessed using the NAFLD activity score on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (0-3), lobular inflammation (0-3), and hepatocellular ballooning (0-2).|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.|||units on a scale||95% Confidence Interval|Mean
2851262|NCT00063635|Secondary|Change in Serum Aspartate Aminotransferase (AST)||baseline and 96 weeks||||IU/L||95% Confidence Interval|Mean
2851263|NCT00063635|Primary|Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L|The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.|baseline and 96 weeks|All enrolled patients were included in analysis of the primary outcome, sustained reduction in ALT level. Patients missing a 96-week ALT measurement were imputed as not achieving a sustained reduction.|||participants|||Number
2851264|NCT00063622|Secondary|Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis|The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
2851265|NCT00063622|Secondary|Number of Participants With Improvement in Fibrosis|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
2851266|NCT00063622|Secondary|Number of Participants With Improvement in Hepatocellular Ballooning|Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
2851267|NCT00063622|Secondary|Number of Participants With Improvement in Lobular Inflammation|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
2851268|NCT00063622|Secondary|Number of Participants With Improvement in Steatosis|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks|||participants|||Number
2851269|NCT00063622|Primary|Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.|Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.|baseline and 96 weeks|All randomized participants were included in the analysis of the primary outcome.|||participants|||Number
2851270|NCT00063570|Secondary|Overall Survival|Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated||||months||Full Range|Median
2851271|NCT00063570|Secondary|Time to Treatment Failure|Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis|||months||Full Range|Median
2851272|NCT00063570|Secondary|Time to Progressive Disease|Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis|||months||Full Range|Median
2851273|NCT00063570|Secondary|Duration of (Confirmed) Complete Response or Partial Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Number of patients with a confirmed complete or partial response.|||months||Full Range|Median
2851274|NCT00063570|Primary|Overall Tumor Response|Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Patients who received at least one dose of study drug (pemetrexed or gemcitabine) were included in the analyses.|||participants|||Number
2851275|NCT00063362|Primary|The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response|"A marked bimodal response is defined by the following three conditions over four consecutive weeks while on triple therapy and after three weeks of ltg:~Montgomery Asberg Depression Rating Scale (MADRS) total score of <= 19~Young Mania Rating Scale (YMRS) total score of <= 12.5~Global Assessment Scale (GAS) score >= 51~The MADRS measures the severity of a subject's depression symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe depression.~The YMRS measures the severity of a subject's manic symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe mania.~The GAS measures a used to rate subjectively the social, occupational, and psychological functioning of a subject and ranges in score from 0-100, with a higher score indicating better social, occupational, and psychological functioning."|Baseline and Week 28||||participants|||Number
2851276|NCT00063258|Primary|Number of Patients With Response|Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.|5 Years to collect outcome information|Analysis limited since of 5 participants enrolled, only 1 evaluable for response.|||Participants|||Number
2851350|NCT00060528|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|77.5 months||||Participants|||Count of Participants
2851351|NCT00060528|Secondary|Overall Survival|Overall survival is defined as the date of on-study to the date of death from any cause or last follow-up.|50 months||||Months||Full Range|Median
2851277|NCT00063154|Secondary|Number of Participants Free From Disease Progression at 3, 6, and 12 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||participants|||Number
2851278|NCT00063154|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first day of pertuzumab treatment (Cycle 1, Day 1) to the time of documented disease progression (per RECIST) or death, whichever occurred first.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||weeks||95% Confidence Interval|Median
2851279|NCT00063154|Secondary|Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||participants|||Number
2851280|NCT00063154|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.|||percentage of participants|||Number
2851281|NCT00063232|Secondary|Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline|HOMA-IR is calculated from Fasting Glucose and Fasting Insulin|from baseline to 48 weeks||||unit||Standard Deviation|Mean
2851282|NCT00063232|Secondary|Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category)|Alanine transaminase <42 U/L is considered normal|from baseline to 48 weeks||||participants|||Number
2851283|NCT00063232|Primary|Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category)|Patients under went liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint is a three point improvement in the histological NASH activity index with a decrease in at least two of the component scores and no worsening of fibrosis or increase in Mallory bodies.|from baseline to 48 Weeks||||participants|||Number
2851284|NCT00062868|Secondary|Grade III-IV Toxicity Rate in Participants Receiving an Extended Dosage Regimen According to the NCI Common Toxicity Criteria (CTCAE) Version 2.0 and the Method of Przepiorka et. al. (Protocol Appendix I).|Grade III-IV toxicity rate is defined as the proportion of participants who receive an extended dose regimen and developed Grade III-IV toxicity attributable to the CTL infusions at any time during the extended dosing regimen. Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).|6 weeks after the final injection|Data is reported for participants who have received an extended dosage regimen.|||proportion of participants||95% Confidence Interval|Number
2851285|NCT00062868|Secondary|Response Rate According to the Harmonization Project (Protocol 8.5.1) or RECIST Criteria.|"Response rate is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) . All patients who receive the first infusion will be evaluable for response.~In patients with detectable tumors and/or lymphadenopathy - response and progression will be evaluated using PET based imaging studies (whenever possible) based on the Harmonization Project (protocol 8.5.1). All available non-PET imaging studies will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee."|Up to 4 months after the last infusion|Data is reported for all participants who has received at least one infusion and has available response assessment data. One participant in LMP1/2 CTLs (ALCI) - Group A Expansion is excluded because of no available response data and one was enrolled to this arm/group twice that response assessment data from the first enrollment is reported.|||proportion of participants||95% Confidence Interval|Number
2851592|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 16|Percentage of participants with Viral Load < 400 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851286|NCT00062868|Primary|Dose Limiting Toxicity (DLT) Rate by the NCI Common Toxicity Criteria (CTCAE) v2.0 and the Method of Przepiorka et al (Protocol Appendix I)|Dose limiting toxicity (DLT) rate is the proportion of participants with DLT. DLT will be defined as any toxicity that is irreversible, life threatening or Grade 3-4 considered to be primarily related to the LMP-specific cytotoxic T-lymphocytes (CTL) injection or development of Grade III-IV Graft versus host disease (GVHD). Toxicity will be evaluated according to the CTCAE Version 2.0. GVHD will be graded by the method of Przepiorka et al (protocol Appendix I).|6 weeks post second CLT infusion|Data is reported for all DLT evaluable participants who received CTL infusions and either completed the DLT assessment period or dropped off the study early due to DLT. One participant in the LMP1/2 CTLs (ALCI) - Group A Expansion was enrolled to this arm/group twice. DLT assessment data from the first enrollment is reported for this participant.|||proportion of participants||95% Confidence Interval|Number
2851287|NCT00062764|Secondary|Mean BMI Change||48 weeks||||kg/m2||Standard Deviation|Mean
2851288|NCT00062764|Secondary|Average Increase in Weight After Treatment||48 weeks||||kg||Full Range|Mean
2851289|NCT00062764|Secondary|Mean Increase of Insulin Sensitivity Index||48 weeks||||percentage||Standard Deviation|Mean
2851290|NCT00062764|Secondary|Number of Patients With Impaired Glucose Tolerance After Treatment||48 weeks||||participants|||Number
2851291|NCT00062764|Primary|Number of Patients With Improvement in Liver Histology|A histological response was defined as a reduction in the NASH activity index by 3 points or more with improvements of at least 1 point each in steatosis, parenchymal inflammation, and hepatocellular injury.|48 weeks||||participants|||Number
2851292|NCT00062751|Secondary|24-hour Trough Concentration (C Trough)|C trough in whole blood measured as nanograms per milliliter (ng/mL).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.|||ng/mL||Standard Deviation|Mean
2851293|NCT00062751|Secondary|Area Under the Concentration-time Curve (AUC) Sum|Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.|||hr*ng/mL||Standard Deviation|Mean
2851294|NCT00062751|Secondary|Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27|Number of participants with antitumor response (CR [disappearance of all target and non-target lesions with normalization of tumor marker level] or PR [at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27.|Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment)|ITT; Final analysis was not conducted.|||participants|||Number
2851295|NCT00062751|Secondary|Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23|Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.|||scores on a scale|||Number
2851296|NCT00062751|Secondary|Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.|||scores on a scale|||Number
2851297|NCT00062751|Secondary|Number of Participants With Survival|Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death|ITT; Final efficacy analysis was not conducted.|||participants|||Number
2851298|NCT00062751|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.|||days||Standard Deviation|Mean
2851299|NCT00062751|Secondary|Percentage of Participants Exhibiting Freedom From Progression|Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions]).|Baseline, 8 weeks, 6 months, 12 months, and 24 months|ITT; Final efficacy analysis was not conducted.|||percentage of participants|||Number
2851387|NCT00059215|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin."|randomization though 30 days after percutaneous coronary intervention (PCI)||||participants|||Number
2851300|NCT00062751|Secondary|Time to Treatment Failure|Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation.|Baseline until Progressive disease, death, or discontinuation of study treatment|ITT; Final efficacy analysis was not conducted.|||days||Standard Deviation|Mean
2851301|NCT00062751|Secondary|Time to Disease Progression|Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions).|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.|||days||Standard Deviation|Mean
2851302|NCT00062751|Secondary|Percentage of Participants With Best Overall Response (Clinical Benefit)|Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease [PD]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.|||percentage of participants||95% Confidence Interval|Number
2851303|NCT00062751|Primary|Percentage of Participants With Objective Response (OR)|OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression|Intent to treat population (ITT) defined as all participants randomized in the study. Final efficacy analysis was not conducted because the development of temsirolimus (CCI-779) for the treatment of breast cancer was terminated.|||percentage of participants||95% Confidence Interval|Number
2851304|NCT00062738|Secondary|Percent Responders|Percent of patients who had a 50% decrease in total HDRS at 8 weeks|8 weeks|intent to treat|||percent of patients who were responders|||Number
2851305|NCT00062738|Primary|Hamilton Depression Scale|total score on HDRS (0-54 higher score is worse)|8 weeks|intent to treat - total patients in the arm|||units on a scale||Standard Deviation|Least Squares Mean
2851306|NCT00062647|Primary|Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation|Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.|12 weeks after start of treatment|The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.|||participants|||Number
2851307|NCT00062439|Secondary|Response|Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.|After completion of induction therapy.|Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.|||percentage of participants||95% Confidence Interval|Number
2851308|NCT00062439|Secondary|Progression-Free Survival at 3 Years|Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.|Eligible patients who began the treatment regimen were included in the analysis.|||percentage of patients||95% Confidence Interval|Number
2851309|NCT00062439|Secondary|Overall Survival|The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.|Eligible patients who began the treatment regimen were included in the analysis.|||years||95% Confidence Interval|Median
2851310|NCT00062439|Primary|Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.|Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.|After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel|Eligible patients who began the treatment regimen were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2851311|NCT00062439|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.|Eligible patients who received the study intervention.|||Participants|||Number
2851312|NCT00062374|Other Pre-specified|Disease Free Survival (DFS)|Overall Survival (OS) and Disease Free Survival (DFS) are the secondary endpoints. Technical problems with measurement of OS leading to unreliable or uniterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only DFS data is being reported.|Every 3 mos for the first 2 yrs, then every 6 mos for 2 years and once a year afterwards, up to 5 years|Technical problems with measurement leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated.|||months||95% Confidence Interval|Median
2851313|NCT00062374|Primary|Histological Response Determined by FDG Uptake Correlates|"The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis.~Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated~Non-Responder= Tumor Regression Grade 3 or higher Responder=Tumor Regression Grade 1 (CR) or Grade 2 (PR)"|Day 15|Technical problems with measurement of FDG-SUV data leading to unreliable or uninterpretable data. Data adjudication was invalid, and needs to be re-adjudicated. Therefore, only histological response is reported.|||participants|||Number
2851314|NCT00062166|Secondary|Number of Participants With Missense or Non-missense Mutations|Count of participants by the type of Von Hippel-Lindau (VHL) gene mutations.|8 years||||Participants|||Count of Participants
2851315|NCT00062166|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|8 years||||Participants|||Count of Participants
2851316|NCT00062166|Secondary|Number of Participants From Which We Obtained Tissue From Pancreatic Lesions and Normal Tissue for Genetic Analysis|Count of participants from which we obtained tissue from pancreatic tumor and normal tissue (when applicable) for Deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and proteins extraction.|initiation of study therapy until 2009, approximately 6 years|Only 319/340 records are available in the database program for this outcome measure. No records are available for the remaining 21 participants.|||Participants|||Count of Participants
2851317|NCT00062166|Secondary|Percentage of Participants With Exon 3 Mutation Compared to Participants With Exon 1 or 2 Von Hippel Lindau (VHL) Mutations Who Required an Intervention|Percentage of patients by the location of germline VHL mutations.|8 years|The exon mutation information only is available in 63 patients. This protocol did not repeat the gene testing in any of the patients.|||percentage of participants|||Number
2851318|NCT00062166|Primary|Number of Patients With Pancreatic Lesions Defined by Simple Cysts, Microcystic Adenomas, Neuroendocrine Tumors & Other Solid Lesions of the Pancreas Who Had Significant Growth in Lesions or Symptoms Related to the Lesions Requiring Surgical Intervention|Pancreatic lesions defined by simple cysts, microcystic adenomas, neuroendocrine tumors and other solid lesions of the pancreas were evaluated by 18F Fludeoxyglucose (18F-FDG-PET) imaging to determine if the participant developed metastatic disease (e.g. tumor spreads to different organs).|8 years|Only 319/340 records are available in the database program for this outcome measure. No records are available for the remaining 21 participants.|||Participants|||Count of Participants
2851319|NCT00062010|Secondary|Progression-free Survival|Time from registration to documented disease progression (RECIST criteria) or death.|Assessed every 6 weeks|Eligible, treated patients|||months||95% Confidence Interval|Median
2851320|NCT00062010|Secondary|Survival|Time from registration to death.|Assessed every 3 months for 1 year then every 6 months|Eligible, treated patients|||months||95% Confidence Interval|Median
2851321|NCT00062010|Primary|Response by RECIST Criteria (v 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 6 weeks|Eligible, treated patients|||participants|||Number
2851322|NCT00061945|Post-Hoc|Number of Participants Achieving Complete Remission|A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) > 1500/μl, no circulating blasts, platelets > 100,000/μl; bone marrow cellularity > 20% with trilineage hematopoiesis, and < 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).|Duration of study (up to 10 years)|Three participants were deemed ineligible and excluded from this analysis.|||participants|||Number
2851323|NCT00061945|Secondary|Overall Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years|||||||
2851324|NCT00061945|Secondary|Disease-free Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years|||||||
2851325|NCT00061945|Secondary|Modulation of Minimal Residual Disease During Treatment With Alemtuzumab (Phase II)||Up to 10 years|||||||
2851326|NCT00061945|Primary|Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)|The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.|8 months|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.|||participants|||Number
2851352|NCT00060528|Secondary|Number of Participants With an Objective Response|Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion...|53 months|All 12 participants with measurable disease were evaluated.|||Participants|||Count of Participants
2851327|NCT00061945|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)|The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.|6 weeks|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.|||mg|||Number
2851328|NCT00061932|Secondary|Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis||Baseline to 6 years|||||||
2851329|NCT00061932|Primary|True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 6 years||||participants||95% Confidence Interval|Number
2851330|NCT00061893|Secondary|Event Free Survival||24 months after start of protocol therapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of Event Free Survival. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.|||percentage of participants||95% Confidence Interval|Number
2851331|NCT00061893|Primary|Occurrence of Severe Toxicity|An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.|The first two cycles (6 weeks) of protocol chemotherapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.|||participants|||Number
2851332|NCT00061633|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.~Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit.~Indeterminate: Inability to determine outcome."|7-14 days following end of antibiotic treatment|"The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."|||participants|||Number
2851333|NCT00061373|Secondary|Bleeding Events|Bleeding events of any type, severity and at any time throughout the 30-day trial period.|2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs|All bleeding events that occurred among all patients enrolled and throughout the 30-day trial period but not classified as a primary outcome event. Bleeding events in this category include asymptomatic ICH(aICH);major systemic bleeding after 72 hours or minor and non-significant bleeding at anytime within the 30-day period.|||participants|||Number
2851334|NCT00061373|Primary|Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)|"This is the primary response outcome measure for subjects in the non-MRI arm. A positive response is measured by a 7 point or more improvement in the NIHSS or for those with less than 7 points at baseline,complete resolution of stroke symptoms.~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|up to 24 hours from the start of study drugs|Clinical improvement on NIHSS of 7 points or greater at 72 hours is the primary response outcome for non-MRI selected patients. Clinical response outcome was analyzed on all patients enrolled; MRI selected and non-selected patients.|||participants|||Number
2851335|NCT00061373|Primary|MRI Selected Arm: Complete Brain Reperfusion|This is the primary response outcome measure for patients in the MRI arm. A positive response is measured by evidence of complete reperfusion (or restoration of blood flow)on the perfusion weighted images (PWI) and mean transit time (MTT) maps of MRIs at 2 hours and sustained at 24 hours.|up to 24 hours from the start of study drugs|Complete reperfusion at 2 and 24 hours was measured in MRI-selected patients only.|||participants|||Number
2851336|NCT00061373|Primary|Other Serious Adverse Event Related to Study Drug Administration, Including Death.|This is a primary safety outcome for all subjects.|From start of study drugs and prior to 72-hour head CT|All Patients completed 72-hour study safety evaluation|||participants|||Number
2851337|NCT00061373|Primary|Major Systemic Hemorrhage|Major systemic hemorrhage is defined bleeding associated with an adjusted decrease in hemoglobin of greater than 5 grams per diluent (g/dL), or and adjusted decrease in hematocrit greater than or equal to 15 percentage points or bleeding causing persistent or significant disability or incapacity such as hemorrhage in the eye.|From the start of study drugs and prior to 72-hour head CT|All patients completed 72-hour safety evaluation|||participants|||Number
2851388|NCT00059215|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.|randomization though 30 days after percutaneous coronary intervention (PCI)||||participants|||Number
2851338|NCT00061373|Primary|Symptomatic Intracerebral Hemorrhage (ICH)|"This is a primary safety outcome or toxicity measure for all subjects.~Symptomatic ICH is defined as the presence of two conditions: evidence of hemorrhage on the 72-hour head CT and an increase in the NIHSS score of 4 or more points from the prior examination. Hemorrhage classifications are according to European Cooperative Acute Stroke Study (ECASS).~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|From the start of study drugs and prior to the 72-hour safety head CT|All patients had a 72-hour safety head CT performed|||participants|||Number
2851339|NCT00061048|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months||||participants|||Number
2851340|NCT00061048|Secondary|Cell Surface Expression of CD52 on Tumor Cells|The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.|6 months||||ABC value||Standard Deviation|Mean
2851341|NCT00061048|Primary|Time to Progression|Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.|60 months||||months||95% Confidence Interval|Median
2851342|NCT00061048|Primary|Overall Survival|Time between the first day of treatment to the day of death.|60 months||||months||95% Confidence Interval|Median
2851343|NCT00061048|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition.~Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma.~Please see the protocol Link module for the full criteria if desired."|60 months||||percentage of participants||95% Confidence Interval|Number
2851344|NCT00060944|Secondary|Overall Survival|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||months||95% Confidence Interval|Median
2851345|NCT00060944|Secondary|Progression-Free Survival - Independent Review|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||months||95% Confidence Interval|Median
2851346|NCT00060944|Secondary|Duration of Response - Independent Review|Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed.|||Months||95% Confidence Interval|Median
2851347|NCT00060944|Secondary|Percentage of Participants Objective Response - Independent Review|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||Percentage of participants||95% Confidence Interval|Number
2851348|NCT00060944|Primary|Time to Progression- Independent Review|Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.|||months||95% Confidence Interval|Median
2851349|NCT00060840|Primary|The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.|"Failure criteria used to measure outcome includes:~Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2~Administration of ≥ 20 inotropic equivalents (IE)~Mean arterial pressure (MAP) ≤ 55 mm Hg~Central venous pressure (CVP) ≥ 16 mm Hg~Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death."|28 days|The analysis was determined for intent-to-treat population.|||Participants|||Number
2851353|NCT00060528|Secondary|Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels|PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial)|53 months|PSA was taken at multiple time points and proportion of patients (pts) who had a decrease in PSA of at least 30% was reported. This is standard reporting procedures for tumor markers (proportion of patients with a response);similar to RECIST reporting where there may be multiple scans obtained but one reports the proportion of pts with a response|||Percentage of participants|||Number
2851354|NCT00060528|Primary|Number of Participants With an Immune Response|Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.|48 months||||Participants|||Count of Participants
2851355|NCT00060424|Secondary|Transplant-related Mortality|Defined as death before day +200 not related to progression of disease.|At 200 days||||Participants|||Count of Participants
2851356|NCT00060424|Secondary|Rate and Types of Infections|Number of infections patients experienced, by infection type.|18 months||||infections|||Number
2851357|NCT00060424|Secondary|Acute Grade II-IV GVHD and Chronic (Extensive) GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.||||Participants|||Count of Participants
2851358|NCT00060424|Secondary|Rate of Relapse|Number of patients with relapsed disease post-transplant. Relapse/progression is defined as 1) Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, 2) circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, or 3) lymph node Biopsy Richter's transformation.|18 months||||Participants|||Count of Participants
2851359|NCT00060424|Primary|Overall Survival|Number of patients surviving 18 months post-transplant.|At 18 months||||Participants|||Count of Participants
2851360|NCT00060346|Primary|Objective Response to Treatment|Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.|Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry|All eligible and treated patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2851361|NCT00060333|Secondary|Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory|Fatigue Assessment: A portion of the Brief Fatigue Inventory will be used to determine fatigue changes throughout the course of radiation. Patients will fill out the questionnaire at baseline, weekly during radiation, and 3 months after the beginning of radiation. Fatigue will be defined as: minor if the patient answers 0-3 (on a 10 point scale), mild for answers of 4-6, and severe for answers of 7-10. The percentage of patients that have worsened (improved) fatigue from baseline to the radiation stage will be calculated. We will also compare fatigue levels at baseline to the 3 month visit. Worsened fatigue is defined as going from minor to mild, minor to severe, or mild to severe. Improved fatigue is defined as going from severe to mild, severe to minor, or mild to minor.|Baseline to up to 3 months||||percentage of participants analyzed|||Number
2851362|NCT00060333|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. The number of participants reporting a grade 3 or higher toxicity are reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 5 years||||number of participants|||Number
2851363|NCT00060333|Secondary|Failure Time|Failure time is defined as the time from randomization to death due to any cause or disease progression. The median failure time will be estimated using the method of Kaplan-Meier.|Time from randomization to death due to any cause or disease progression (up to 5 years)||||||95% Confidence Interval|Median
2851364|NCT00060333|Secondary|Survival Time|Survival time: Survival time is defined as the time from randomization to death due to any cause. The median survival time will be estimated using the method of Kaplan-Meier.|up to 5 years||||||95% Confidence Interval|Median
2851365|NCT00060333|Secondary|Incidence of Regional and Systemic Metastases|Incidence of regional and systemic metastasis: Incidences will be calculated for each cohort and 95% confidence intervals will be constructed using the properties of the binomial distribution.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
2851366|NCT00060333|Primary|2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence|The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.|Within 2 years after treatment||||percentage of patients with LR||95% Confidence Interval|Number
2851367|NCT00060008|Primary|Tumor Progression as Measured by Tumor Area and Volume at 1 Year.|We correlated SUVmax and change in tumor volume over the subsequent year|One year||||percentage of change|Participants|Full Range|Median
2851593|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 8|Percentage of participants with Viral Load < 400 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851368|NCT00059839|Primary|Event-free Survival (EFS)|Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.|From first enrollment up to 3 years.|64 patients from Arm I were analyzed for this outcome measure, one patient was deemed ineligible. 61 patients from Arm II were analyzed for this outcome measure, three patients were deemed ineligible.|||percentage of participants||95% Confidence Interval|Number
2851369|NCT00059787|Secondary|To Determine the Tolerability of Twelve Months of Maintenance Treatment||Twelve months of maintenance||||participants|||Number
2851370|NCT00059787|Secondary|To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin||The duration of the study||||months||95% Confidence Interval|Median
2851371|NCT00059787|Secondary|To Measure EGFR Gene Amplification in Tumor Specimens||The duration of the study for up to 7 years|Tumor specimens were evaluated for EGFR gene amplification in 20 patients|||number of tumor specimens|||Number
2851372|NCT00059787|Primary|The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen|Adverse event assessment|For the duration of the study up to 7 years|Patients enrolled on all stratums included|||percentage of participants|||Number
2851373|NCT00059787|Primary|Pathologic Complete Response Rates|Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.|Up to 7 years|Patients who had optimally debulking surgery|||participants|||Number
2851374|NCT00059475|Primary|Response Rate|Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|6 years|The number of participants analyzed and results are correct. We do not have the response rate data for all patients.|||participants|||Number
2851375|NCT00059475|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|11 months||||Participants|||Number
2851376|NCT00059475|Primary|Immunologic Response Rate|Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.|11 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.|||Participants|||Number
2851377|NCT00059332|Secondary|Mortality||3 months||||participants|||Number
2851378|NCT00059332|Secondary|Symptomatic Intracranial Hemorrhage||3 month||||participants|||Number
2851379|NCT00059332|Secondary|Serious Adverse Events||3 months||||participants|||Number
2851380|NCT00059332|Secondary|Stroke Impact Scale|"The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.~Physical problems~Memory and thinking~Mood and emotions~Communication, reading and understanding~Daily activities~Mobility at home and in the community~Affected hand use~Hobbies and activities participation"|3 months||||units on a scale||Inter-Quartile Range|Median
2851381|NCT00059332|Secondary|Barthel Index|"The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:~FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)"|3 months||||units on a scale||Inter-Quartile Range|Median
2851382|NCT00059332|Secondary|NIH Stroke Scale|"The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:~1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention"|3 months||||units on a scale||Inter-Quartile Range|Median
2851383|NCT00059332|Secondary|Modified Rankin Score ≤2|Functional independence based on modified Rankin score|3 months||||participants|||Number
2851384|NCT00059332|Secondary|Modified Rankin Score of 0 or 1|Minimal or no disability based on the modified Rankin score|3 months||||participants|||Number
2851385|NCT00059332|Primary|Modified Rankin Scale|"Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.~0 No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|3 months after stroke onset||||units on a scale||Inter-Quartile Range|Median
2851386|NCT00059215|Secondary|Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE.~Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL.~MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization"|randomization though 30 days after percutaneous coronary intervention (PCI)||||participants|||Number
2851389|NCT00059215|Primary|Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL."|randomization though 30 days after percutaneous coronary intervention (PCI)|Patients who received at least one dose of study drug|||participants|||Number
2851390|NCT00059228|Primary|Beck Depression Inventory|The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 - 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome.|Baseline|The analysis included only those subjects who had taken Estradiol and Placebo|||units on a scale||Standard Error|Mean
2851391|NCT00059228|Primary|Beck Depression Inventory|The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 - 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome.|6 weeks|The analysis included only those subjects who had taken Estradiol and Placebo|||Units on a scale||Standard Error|Least Squares Mean
2851392|NCT00058825|Secondary|Median Time to Engraftment With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days||||days||Full Range|Median
2851393|NCT00058825|Secondary|Number of Patients Who Engrafted With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days||||participants|||Number
2851394|NCT00058825|Secondary|2-year Overall Survival|Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method.|2 years||||percentage of participants||95% Confidence Interval|Number
2851395|NCT00058825|Secondary|2-year Relapse-free Survival|Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method.|2 years||||percentage of participants||95% Confidence Interval|Number
2851396|NCT00058825|Secondary|Chronic Graft Versus Host Disease|Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant|1 year||||participants|||Number
2851397|NCT00058825|Secondary|Acute Graft Versus Host Disease|Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant|100 days||||participants|||Number
2851398|NCT00058825|Secondary|Donor Chimerism Engraftment of Greater Than 50%|Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days|30 days|Patients engrafted|||participants|||Number
2851399|NCT00058825|Secondary|Time in Days to ANC Engraftment|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days||||days||Full Range|Median
2851400|NCT00058825|Primary|Transplant Related Mortality (TRM)|Percentage of patients with transplant related mortality|100 days||||percentage of participants||97.5% Confidence Interval|Number
2851401|NCT00058552|Secondary|Kaplan Meier Estimate of Percentage of Participants Who Were Free of Disease Progression at 3, 6, and 12 Months|Per RECIST v 1.1, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|3, 6, and 12 months|Efficacy Analysis Population.|||percentage of participants|||Number
2851402|NCT00058552|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population. Seventeen participants in pertuzumab 420 mg arm and 33 participants in pertuzumab 1050 mg were censored for this analysis.|||weeks||95% Confidence Interval|Median
2851403|NCT00058552|Secondary|Percentage of Participants Who Died|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population.|||percentage of participants|||Number
2851404|NCT00058552|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Only responders (CR or PR) were included in the analysis.|||weeks||95% Confidence Interval|Median
2851405|NCT00058552|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.|||weeks||95% Confidence Interval|Median
2851415|NCT00058240|Secondary|Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years||||patients|||Number
2851406|NCT00058552|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.|||percentage of participants|||Number
2851407|NCT00058552|Primary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or Cancer Antigen 125 (CA-125) Changes|Response by tumor measurement occurred if there was documented and confirmed CR or PR determined by 2 consecutive investigator assessments that were at least 28 days apart. Response was assessed by either the RECIST v 1.1 or by CA-125 changes, based on measurable or non-measurable disease at baseline. Per RECIST v 1.1 (for measurable disease), CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Per CA-125 changes (for non-measurable disease), CR: decrease in the CA-125 to within the normal limits and less than (<) 40 international units per milliliter (IU/mL) and no clinical or radiological evidence of disease, PR: a greater than (>) 50 percent (%) decrease in CA-125 values from baseline, and no clinical or radiological evidence of new lesions.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population: All participants who received at least 1 dose of study drug and either underwent at least one postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.|||percentage of participants||95% Confidence Interval|Number
2851408|NCT00058539|Secondary|Serum Concentrations of Pertuzumab||Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36|Pharmacokinetic evaluable participants|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
2851409|NCT00058539|Secondary|Percentage of Participants Who Progressed at 3, 6 and 9 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of participants who were free from disease progression was calculated by subtracting the number of participants with disease progression at that time point from the total population at risk of disease progression, multiplied by 100.|3, 6, and 9 months|Efficacy analysis population|||percentage of participants|||Number
2851410|NCT00058539|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|No participants experienced either CR or PR.||||||
2851411|NCT00058539|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.|||weeks||95% Confidence Interval|Median
2851412|NCT00058539|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with an event divided by the number of participants analyzed, multiplied by 100.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.|||percentage of participants|||Number
2851413|NCT00058539|Primary|Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.|3 months|Efficacy analysis population.|||percentage of participants|||Number
2851414|NCT00058539|Primary|Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population: All participants who received at least 1 dose of study drug and either underwent at least 1 postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.|||percentage of participants||95% Confidence Interval|Number
2851441|NCT00057863|Secondary|Progression-free Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until objective or symptomatic progression or death, assessed up to 7 years||||weeks||95% Confidence Interval|Mean
2851416|NCT00058240|Primary|Recommended Dose Level of Flavopiridol|Recommended dose determined by number of DLTs [non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1.|Up to 6 weeks||||mg/m^2|||Number
2851417|NCT00058240|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|DLTs were defined as non-hematologic toxicity of grade 3 or greater severity (excluding transient liver function abnormalities, transient electrolyte abnormalities that are not life threatening, fatigue, or diarrhea that resolve within 4 days), or in some case grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity). Hematologic toxicity were evaluated by the modified NCI criteria and followed closely. Dose limiting only if grade 4 thrombocytopenia or neutropenia persists for 7 days or greater. Inability to continue with cycle 2 by 7 weeks for reasons other than progression of disease will also be considered a DLT.The National Cancer Institute Common Toxicity Criteria will be used to characterize toxicity.|up to 7 weeks||||patients|||Number
2851418|NCT00058214|Secondary|Time to Progression|Estimated using the product-limit method of Kaplan and Meier. Progression was defined as the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months.|From the date of registration to the date of documented PSA progression, assessed up to 6 years||||months||95% Confidence Interval|Median
2851419|NCT00058214|Primary|PSA Response|A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient's best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.|Up to 6 years||||percentage of participants|||Number
2851420|NCT00058123|Secondary|Overall Survival|based on date of study entry|2 years|Survival time was known for all 45 patients and 13 patients were censored as they were alive at last contact|||weeks||95% Confidence Interval|Median
2851421|NCT00058123|Secondary|Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas|Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0|2 years||||Participants|||Count of Participants
2851422|NCT00058123|Primary|Percentage of Participants With Progression Free Survival|Participants evaluated from date of study entry to the 6 month scan for progression|6 months||||percentage of participants|||Number
2851423|NCT00058123|Primary|Proportion of Participants With Objective Response Rate (ORR)|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).~ORR = CR + PR"|2 years||||Participants|||Count of Participants
2851424|NCT00058058|Secondary|AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast|Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.|within 90 days of a negative mammogram of the study breast|All eligible participants with an analyzable MRI|||Participants|||Count of Participants
2851425|NCT00058058|Secondary|MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy|"Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the Final BI-RADs, where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4)."|within 90 days of a negative mammogram of the study breast|All eligible participants with an analyzable MRI|||Participants|||Count of Participants
2851426|NCT00058058|Primary|MRI Diagnostic Yield of Cancers in the Contralateral Breast|"To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.~the Test status was defined based on combinations of the following 4 factors:~The initial BI-RADs: from the MRI of the contralateral breast~The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).~Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI~Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI"|within 90 days of a negative mammogram of the study breast|All eligible participants with an analyzable MRI|||Participants|||Count of Participants
2851442|NCT00057863|Primary|Overall Objective Response Rate (CR+PR)|95% confidence interval will be estimated via binomial proportions.|Up to 7 years||||participants|||Number
2851427|NCT00058019|Secondary|Time to Progression|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years||||Days||95% Confidence Interval|Median
2851428|NCT00058019|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|up to 3 years||||Days||95% Confidence Interval|Median
2851429|NCT00058019|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years||||Days||95% Confidence Interval|Median
2851430|NCT00058019|Primary|Safety and Toxicity of Ixabepilone|Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.|up to 3 years||||participants|||Number
2851431|NCT00058019|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|up to 3 years||||participants|||Number
2851432|NCT00057954|Secondary|Progression-free Survival|Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.|Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression|all 6 enrolled patients|||days||95% Confidence Interval|Median
2851433|NCT00057954|Secondary|100-day Overall Survival|Proportion of patients who survived 100 days or more after enrolled on the study|Assessed at least twice a week for the first 60 days and weekly until day 100.|all 6 enrolled patients|||Proportion of participants||95% Confidence Interval|Number
2851434|NCT00057954|Primary|Proportion of Participants With Successful Engraftment||Assessed daily during inpatient stay|all enrolled 6 patients|||Proportion of participants||95% Confidence Interval|Number
2851435|NCT00057941|Primary|Clinical Benefit Rate|Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.|assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years|141 eligible and treated patients, 72 on Arm I (Anastrozole and ZD1839) and 69 on Arm II (Fulvestrant and ZD1839)|||percentage of participants||95% Confidence Interval|Number
2851436|NCT00057876|Secondary|Overall Response|Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.|assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3|Eligible patients|||participants|||Number
2851437|NCT00057876|Secondary|Progression-free Survival Time|Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|67 eligible patients with data on progression-free survival(PFS)|||Months||95% Confidence Interval|Median
2851438|NCT00057876|Primary|Overall Survival Time|Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|71 eligible patients|||Months||95% Confidence Interval|Median
2851439|NCT00057863|Secondary|Toxicities, Assessed and Graded According to CTCAE Version 3.0|Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities|Up to 7 years|There were 135 cycles administered.|||percentage of grade 3/4|||Number
2851440|NCT00057863|Secondary|Overall Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until death, assessed up to 7 years||||weeks||95% Confidence Interval|Mean
2851444|NCT00057837|Secondary|Duration of Response|Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started.|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only eligible and treated patients with response are included in this analysis.|||Months||95% Confidence Interval|Median
2851445|NCT00057837|Primary|Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only treated and eligible patients are included in this analysis.|||proportion of participants||90% Confidence Interval|Number
2851446|NCT00057811|Primary|Toxic Death|Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.|||participants|||Number
2851447|NCT00057811|Primary|Minimal Residual Disease|The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).|Not Provided|Population analyzed included patients submitting samples for minimal disease assay at end induction|||percentage of samples analyzed||95% Confidence Interval|Number
2851448|NCT00057811|Primary|Response Rate|Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..|Up to 5 years|Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).|||percentage of participants analyzed||95% Confidence Interval|Number
2851449|NCT00057811|Primary|Grade ≥ 3 Stomatitis|The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.|||participants|||Number
2851450|NCT00057785|Secondary|Chemotherapy Compliance||From start of treatment to end of treatment|||||||
2851451|NCT00057785|Secondary|Other Acute and Late Toxicities||From start of treatment to last follow-up|||||||
2851452|NCT00057785|Secondary|Whole Mouth Saliva Output Relative to Pretreatment Measurements||From start of treatment to 1 year|||||||
2851453|NCT00057785|Secondary|Rate of Locoregional Control at 2 Years||From registration to 2 years|||||||
2851454|NCT00057785|Secondary|Rate of Xerostomia at 1 Year (Grade ≥ 2)||From start of treatment to 1 year|||||||
2851455|NCT00057785|Primary|Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered|Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.|From start of treatment to end of treatment|First 57 eligible patients who started study treatment.|||participants|||Number
2851456|NCT00057746|Primary|Incidence of Chronic Neurotoxicity|Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.|From study registration to one year.||||percentage of participants||95% Confidence Interval|Number
2851457|NCT00023673|Secondary|Number of Patients With Complete Response at 3 Months After Completion of Therapy|"Complete response means no evidence of tumor on the CT scan."|From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy.|Eligible patients from Phase I and II 74 Gy arms who started study treatment.|||Participants|||Count of Participants
2851458|NCT00023673|Secondary|Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level)|Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.|From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure|||Gy (mean dose)||Full Range|Mean
2851459|NCT00023673|Secondary|Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level)|Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.|From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure|||Percent (V20)||Full Range|Median
2851460|NCT00023673|Secondary|Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities.|Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT.|Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|Eligible patients from Phase I and II 74 Gy arms who started study treatment. Additionally for late RT toxicity, those who have toxicity data at least 90 days from start of RT.|||Participants|||Count of Participants
2851461|NCT00023673|Primary|Percentage of Patients Who Survive at Least 12 Months|Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.|From registration to 1 year|Eligible patients at the MTD dose level who started protocol treatment.|||percentage of participants||95% Confidence Interval|Number
2851462|NCT00023673|Primary|Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy|"Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%.~Rating scale: 0 = not the MTD, 1 = MTD"|From start of treatment to 90 days|The first seven eligible patients who started protocol treatment at each dose level.|||units on a scale|||Number
2851463|NCT00057681|Secondary|K-SADS Mania Rating Scale|The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.|Measured at Week 8|KMRS data were analyzed for all subjects completing 8 weeks of the study.|||units on a scale||Standard Deviation|Mean
2851464|NCT00057681|Secondary|Modified Side Effects Form for Children and Adolescents|The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.|Measured at Week 8|Modified Side Effects Form for Children and Adolescents data were analyzed for all subjects completing 8 weeks of the study.|||side effects at week 8||Standard Deviation|Mean
2851465|NCT00057681|Primary|Clinical Global Impressions-Bipolar Mania Improvement|The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Measured at Week 8|CGI-BP mania improvement data were analyzed for all subjects completing 8 weeks of the study.|||units on a scale||Standard Deviation|Mean
2851466|NCT00057577|Other Pre-specified|Serious Adverse Events|Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study|Throughout study, up to 54 months||||number of SAE's|||Number
2851467|NCT00057577|Primary|Number of Participants in Recurrence According to the LIFE and HRSD|Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)|Measured up to Month 36 from recovery||||Participants|||Count of Participants
2851468|NCT00057577|Primary|Number of Participants in Recovery According to the LIFE and HRSD|Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)|Through 36 months of treatment||||number participants that reach recovery|||Number
2851469|NCT00057577|Primary|Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)|Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)|Through month 18 of treatment||||number participants that reach remission|||Number
2851470|NCT00057551|Primary|Remission|Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits|12 weeks|Refers to # of subjects who completed 12 weeks of treatment|||percentage of participants|||Number
2851471|NCT00057330|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in a subject's offspring.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
2851472|NCT00057330|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)|NOCDs included adverse events (AEs) as autoimmune disorders, asthma, type I diabetes, allergies. MSCs included AEs prompting emergency room or physician visits unrelated to common diseases or routine visits for physical examination or vaccination, or SAEs unrelated to common diseases. SAEs included medical occurrences either life-threatening, requiring hospitalization, or resulting in death, disability/incapacity or congenital anomaly/birth defect in a subject's offspring. Common diseases included upper respiratory infections (URIs), sinusitis, pharyngitis, gastroenteritis, urinary tract infection, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. The following were not reported if not considered as SAEs and occurring more than 30 days post vaccination: URIs, sinusitis, pharyngitis, gastroenteritis, injury, or visits for routine physical examination or vaccination. AEs are described, using Medical Dictionary for Regulatory Activities' preferred terms.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
2851473|NCT00057330|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs have been tabulated for a 31-day period. An unsolicited AE was any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
2851474|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed were fatigue, headache, malaise and fever (oral/axillary/tympanic).~Grade 3 headache, fatigue, malaise = symptom that prevented normal activities.~Grade 3 fever = temperature above 39.0 degrees Celsius.~Related = symptom assessed by the investigator as causally related to the vaccination"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
2851475|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.~Grade 3 pain = pain that prevented normal activities.~Grade 3 redness/swelling = redness/swelling above 30 mm and persisting for more than 24 hours"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
2851476|NCT00057330|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.~Solicited general symptoms assessed were fatigue, headache, malaise and fever (defined as oral/axillary/tympanic temperature equal to or above 37.5 degrees Celsius)."|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.|||Subjects|||Number
2851477|NCT00057330|Secondary|Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.|Titers for Anti-HSV neutralizing antibodies are presented as Geometric Mean Titers (GMTs), and are expressed in Estimated Doses (ED), that is, the reciprocal of the dilution necessary to achieve neutralization. Antibody titers below the lowest level of quantification were not calculated .|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.|||ED||95% Confidence Interval|Geometric Mean
2851478|NCT00057330|Secondary|Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). The seroprotection cut-off of the assay was 40 EU/mL|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2851479|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
2851480|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
2851481|NCT00057330|Secondary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
2851482|NCT00057330|Primary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.|||Subjects|||Number
2851483|NCT00056862|Secondary|Time to Negativity|Time from treatment initiation to the first negative HCV RNA test during treatment|24 weeks||||days||95% Confidence Interval|Median
2851484|NCT00056862|Secondary|Slope of Second Phase Decline in HCV Levels|The 2nd phase slope is defined as the slope of the logarithmic viral levels from week 1 to week 4 of treatment (see Neumann et al, Science, 1998).|day 7 to day 28||||logIU/mL||Standard Deviation|Mean
2851485|NCT00056862|Primary|Virological Response Category (Per Protocol)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after therapy|Per protocol|||participants|||Number
2851486|NCT00056862|Secondary|First Phase Decline in Logarithm of HCV RNA Level|The 1st phase decline is defined as the log difference between baseline HCV RNA level and the level on day 2 of treatment (see Neumann et al, Science, 1998).|2 days||||logIU/mL||Standard Deviation|Mean
2851487|NCT00056862|Primary|Virological Response (Intention to Treat)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after stopping therapy|Intention-to-treat|||participants|||Number
2851488|NCT00056563|Secondary|The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation|Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher score indicates that the condition is worse.|at six months||||units||95% Confidence Interval|Mean
2851489|NCT00056563|Primary|The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline.||at six months||||Hours per day||95% Confidence Interval|Mean
2851490|NCT00056550|Secondary|Local Assessment of Thromboembolism by Physical Examination.|The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.|30 days after last dose|14 patients were included in the trial and treated with rhAT.|||Participants in study|||Number
2851491|NCT00056550|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).|Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).|Baseline, last day of dosing and day 7 (+ or - 1 day)|14 patients who received at least 1 dose of rhAT were included in the Safety population. During the central review of the duplex ultrasound, 1 delivery patient was diagnosed with a DVT at baseline, and was not evaluable for efficacy, the patient was excluded from the PP population.|||participants|||Number
2851594|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 4|Percentage of participants with Viral Load < 400 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851492|NCT00056498|Secondary|Negative Symptom Total Score by Week and Treatment Group|The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change.|Baseline and every two weeks for 16 weeks.|The intent to treat analysis included all participants who received at least one dose of study medication and completed the SANS rating at the specified treatment week.|||units on a scale||Standard Deviation|Mean
2851493|NCT00056498|Secondary|Neuropsychological Testing - Overall Composite Z-score|The neuropsychological testing measured attention, executive function/problem solving, motor speed, processing speed/response generation, and verbal, visual, and working memory. The individual test raw scores were converted to z-scores and an overall composite z-score was computed from the average of the individual test z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance.|Baseline and Week 16|Two participants completed 9 or fewer of the 13 individual tests in the neurocognitive battery, and were omitted from calculation of the overall composite score|||z-score||Standard Deviation|Mean
2851494|NCT00056498|Primary|Positive Symptom Item Scores by Week and Treatment Group|"The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change."|Baseline and every two weeks for 16 weeks.|The intent to treat analysis included all participants who received at least one dose of study medication and completed the BPRS rating at the specified week.|||units on a scale||Standard Deviation|Mean
2851495|NCT00056472|Other Pre-specified|Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.|The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.|Weeks 1 to 12||||Scores on Ham-D||Standard Error|Mean
2851496|NCT00056472|Secondary|Scores on CGI-S Compared to Baseline Over the Course of the Trial|A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.|Weeks 1 to 12||||units on CGI scale||Standard Error|Mean
2851497|NCT00056472|Primary|Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial|"Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.~Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior."|Weeks 1 to 12||||participants|||Number
2851498|NCT00056407|Secondary|Mean Change From Baseline in Testosterone at Month 48|Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||percent change||Standard Deviation|Mean
2851499|NCT00056407|Secondary|Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48|Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.|Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||participants|||Number
2851500|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48|The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Error|Mean
2851501|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48|The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Error|Mean
2851514|NCT00056407|Secondary|Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment|The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).|Baseline to Year 4|Efficacy Population|||participants|||Number
2851502|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48|The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||points on a scale||Standard Error|Mean
2851503|NCT00056407|Secondary|Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48|The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||points on a scale||Standard Error|Mean
2851504|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48|The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.|||points on a scale||Standard Error|Mean
2851505|NCT00056407|Secondary|Overall Survival|Overall survival is assessed as the number of deaths reported throughout the study.|From time informed consent is signed to 4-month Safety Follow-Up period|Efficacy Population|||number of deaths|||Number
2851506|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematospermia|Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.|Baseline through Year 4|Efficacy Population|||participants|||Number
2851507|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematuria|Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.|Baseline to Year 4|Efficacy Population|||participants|||Number
2851508|NCT00056407|Secondary|Number of Participants With at Least One Urinary Tract Infection (UTI)|A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population|||participants|||Number
2851509|NCT00056407|Secondary|Number of Participants With at Least One Event of Acute Urinary Retention (AUR)|A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.|Years 1-2 and Overall (Years 1-4)|Efficacy Population|||participants|||Number
2851510|NCT00056407|Secondary|Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms|Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.|Years 1-2, Overall (Years 1-4)|Efficacy Population|||participants|||Number
2851511|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48|Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.|Baseline and Months 12, 24, 36, and 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||milliliters/second||Standard Error|Mean
2851512|NCT00056407|Secondary|Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48|Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).|Baseline, Month 24, and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.|||percent change||Standard Error|Mean
2851513|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline to Year 4 (Month 48)|Efficacy Population, last observation carried forward (LOCF). In the LOCF approach, missing values at post-baseline assessments are replaced with the participant's previous non-missing post-baseline assessment. The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Error|Mean
2851562|NCT00054847|Secondary|Myocardial Infarction||Within 1 year of bypass surgery||||participants|||Number
2851563|NCT00054847|Secondary|Death||Within 1 year of surgery.||||participants|||Number
2851515|NCT00056407|Secondary|Treatment Alteration Score|The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||points on a scale||Standard Deviation|Mean
2851516|NCT00056407|Secondary|Number of Cancer-positive Cores|The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.|Baseline to Year 4|Prostate Cancer Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||number of cores||Standard Deviation|Mean
2851517|NCT00056407|Secondary|Percentage of Core Involved at Diagnosis|The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.|Baseline to Year 4|Prostate Cancer Population: all participants in the Efficacy Population who received a post-baseline diagnosis of prostate cancer by the central pathology laboratory. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||percentage of core||Standard Deviation|Mean
2851518|NCT00056407|Secondary|Volume of HGPIN at Biopsy|The amount of prostate biopsy tissue with HGPIN was measured.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||cc*10^-3 (microliter)||Standard Deviation|Mean
2851519|NCT00056407|Secondary|Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy|"The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category (HGPIN or prostate cancer diagnosis) and again in the last category (HGPIN, ASAP, or prostate cancer diagnosis)."|Baseline to Year 4|Biopsied Population: the number analyzed is the total number in the population|||participants|||Number
2851520|NCT00056407|Secondary|Number of Participants With the Indicated Gleason Score at Diagnosis|Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.|Baseline to Year 4|Biopsied Population: all randomized participants with a negative entry biopsy who received at least 1 dose of study treatment and who had at least 1 biopsy reviewed by the central pathology lab. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.|||participants|||Number
2851521|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, restricted crude rate: the number of prostate cancer events is based on the the number of participants who had at least one biopsy during the time period. Ns at Years 1-2 and Years 3-4 are the number who had a biopsy in those time periods; the overall n is the number of participants who had 1 or more biopsy during Years 1-4.|||participants|||Number
2851522|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)|Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, modified crude rate: participants who either were diagnosed with prostate cancer during the study or had an end of time period biopsy. N for each time period is the number who either had at least 1 biopsy in the final 6 months of the time period or had a positive biopsy anytime during the time period.|||participants|||Number
2851523|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population: all randomized participants with a negative entry biopsy, as determined by the CPL, who received at least 1 dose of study drug. The crude rate approach included all participants at risk at the beginning of each time period .|||participants|||Number
2851524|NCT00056316|Secondary|Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.|||Points on a scale||Standard Deviation|Mean
2851525|NCT00056316|Primary|Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.|||Points on a scale||Standard Deviation|Mean
2851526|NCT00056316|Secondary|Negative Affect Schedule (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.|||Points on a scale||Standard Deviation|Mean
2851527|NCT00056316|Primary|Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All randomized participants|||Points on a scale||Standard Deviation|Mean
2851528|NCT00056160|Secondary|Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)|The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.|30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.|||Weeks||Standard Deviation|Mean
2851529|NCT00056160|Secondary|Myeloma Response|The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to Unblinding (07 Jun 2005)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.|||Participants|||Number
2851530|NCT00056160|Secondary|Overall Survival|Overall survival was calculated as the time from randomization to death from any cause.|170 weeks (median overall survival of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.|||Weeks||95% Confidence Interval|Median
2851531|NCT00056160|Primary|Time to Tumor Progression (TTP)|Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.|60 weeks (median Time To Progression of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.|||Weeks||95% Confidence Interval|Median
2851532|NCT00055692|Other Pre-specified|Disease Stability||At 6 months|||||||
2851533|NCT00055692|Primary|To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition||During and after treatment|No data was collected by the principal investigator for this outcome||||||
2851534|NCT00055692|Primary|Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition||During treatment|Six of eight patients were analyzed after 8 weeks of bevacizumab therapy|||pg/mL||Standard Deviation|Mean
2851535|NCT00055692|Primary|Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.||Baseline and 8 weeks after bevacizumab therapy|Eight consecutive patients enrolled at one site were evaluated before and at 8 weeks after bevacizumab therapy with DCE-MRI.|||relative MR units||Standard Deviation|Mean
2851536|NCT00055692|Primary|Disease Response|MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|MRI is required at weeks 8, 16 and then every 12 weeks until disease progression||||participants||95% Confidence Interval|Number
2851537|NCT00055692|Primary|Progression-free Survival||At 6 months||||percentage of participants||95% Confidence Interval|Number
2851538|NCT00055601|Secondary|Bladder-intact Survival Rate (5 Years)|Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method.|From the date of randomization to five years.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2851539|NCT00055601|Secondary|Complete Response After Induction|Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass.|From randomization to eight weeks|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2851585|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 72|Percentage of participants with Viral Load < 400 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851586|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 64|Percentage of participants with Viral Load < 400 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851540|NCT00055601|Primary|Treatment Completion Rate|Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction.|From randomization to 11 weeks|All eligible patients who started study treatment.|||percentage of participants||95% Confidence Interval|Number
2851541|NCT00055497|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.|||Scores on a scale||95% Confidence Interval|Mean
2851542|NCT00055497|Secondary|Number of Participants Achieving CR-70 - LOCF|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF imputation was used for missing data.|||Participants|||Number
2851543|NCT00055497|Secondary|Number of Participants Achieving CR-100 - LOCF|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.|||Participants|||Number
2851544|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56||||Participants|||Number
2851545|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.|||Participants|||Number
2851546|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 70 (CR-70)- NRI|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and to Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-70 not achieved) was used for missing data.|||Participants|||Number
2851547|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 100 (CR-100) - NRI|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.|||Participants|||Number
2851587|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 56|Percentage of participants with Viral Load < 400 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851548|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.|||Participants|||Number
2851549|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.|||Participants|||Number
2851550|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.|||Participants|||Number
2851551|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.|||Participants|||Number
2851552|NCT00055471|Secondary|Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)|Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
2851553|NCT00055471|Secondary|Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)|Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
2851554|NCT00055471|Secondary|Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)|"Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).~Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
2851555|NCT00055471|Secondary|Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)|Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
2851556|NCT00055471|Secondary|Change in Total Prostate Specific Antigen (PSA)|"Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).~Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054|||Percentage Change||Standard Deviation|Mean
2851557|NCT00055471|Secondary|Total Prostate Specific Antigen (PSA) Concentration|Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).|Baseline to Day 15.|All dosed patients.|||ng/ml||Full Range|Geometric Mean
2851558|NCT00055471|Primary|Dose Limiting Toxicities (DLTs)|"DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment.~The numbers of patients with a DLT are reported."|Baseline to Day 29.||||Participants|||Number
2851559|NCT00055237|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|70 months|"All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events.~Cohort 1 and 2 are reported together."|||Participants|||Count of Participants
2851560|NCT00055237|Primary|Response Rate|Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.|36 months|Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.|||Percentage of participants||95% Confidence Interval|Mean
2851561|NCT00054847|Secondary|Stroke||Within 1 year of bypass surgery||||participants|||Number
2851564|NCT00054847|Primary|To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.|The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.|1 year|All analyses were performed according to intention to treat. The study was designed to have 90%power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5% and an expected 1-year catheterization completion rate of 65%. .|||grafts|Participants||Number
2851565|NCT00054756|Primary|TSH Response to TRH|Serum TSH Levels in Response to TRH Administration|180 minutes from infusion|2 participants did not have results drawn at 180 minutes|||mcIU/mL||Full Range|Mean
2851566|NCT00054717|Secondary|Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities|NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|240 Weeks|Safety Analysis Set with On-Treatment data (SAF-OT), all patients treated with at least one dose of study drug and have on-treatment laboratory values|||Percentage of participants|||Number
2851567|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 96|Percentage of participants with Viral Load < 50 copies/mL|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851568|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 88|Percentage of participants with Viral Load < 50 copies/mL|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851569|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 80|Percentage of participants with Viral Load < 50 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851570|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 72|Percentage of participants with Viral Load < 50 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851571|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 64|Percentage of participants with Viral Load < 50 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851572|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 56|Percentage of participants with Viral Load < 50 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851573|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 48|Percentage of participants with Viral Load < 50 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851574|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 40|Percentage of participants with Viral Load < 50 copies/mL|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851575|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 32|Percentage of participants with Viral Load < 50 copies/mL|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851576|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 24|Percentage of participants with Viral Load < 50 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851577|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 16|Percentage of participants with Viral Load < 50 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851578|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 8|Percentage of participants with Viral Load < 50 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851579|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 4|Percentage of participants with Viral Load < 50 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851580|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 2|Percentage of participants with Viral Load < 50 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851581|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 50 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851582|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 96|Percentage of participants with Viral Load < 400 copies/mL|week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851583|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 88|Percentage of participants with Viral Load < 400 copies/mL|week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851584|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 80|Percentage of participants with Viral Load < 400 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851595|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 2|Percentage of participants with Viral Load < 400 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851596|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 400 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851597|NCT00054717|Secondary|Time to New CDC Class C Progression Event or Death.|Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death|after 48 weeks of treatment|Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2851598|NCT00054717|Secondary|Mean Change From Baseline to Week 96 in CD4+ Cell Count||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851599|NCT00054717|Secondary|Mean Change From Baseline to Week 88 in CD4+ Cell Count||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851600|NCT00054717|Secondary|Mean Change From Baseline to Week 80 in CD4+ Cell Count||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851601|NCT00054717|Secondary|Mean Change From Baseline to Week 72 in CD4+ Cell Count||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851602|NCT00054717|Secondary|Mean Change From Baseline to Week 64 in CD4+ Cell Count||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851603|NCT00054717|Secondary|Mean Change From Baseline to Week 56 in CD4+ Cell Count||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851604|NCT00054717|Secondary|Mean Change From Baseline to Week 48 in CD4+ Cell Count||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851605|NCT00054717|Secondary|Mean Change From Baseline to Week 40 in CD4+ Cell Count||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851606|NCT00054717|Secondary|Mean Change From Baseline to Week 32 in CD4+ Cell Count||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851607|NCT00054717|Secondary|Mean Change From Baseline to Week 24 in CD4+ Cell Count||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851608|NCT00054717|Secondary|Mean Change From Baseline to Week 16 in CD4+ Cell Count||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851609|NCT00054717|Secondary|Mean Change From Baseline to Week 8 in CD4+ Cell Count||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851610|NCT00054717|Secondary|Mean Change From Baseline to Week 4 in CD4+ Cell Count||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851611|NCT00054717|Secondary|Mean Change From Baseline to Week 2 in CD4+ Cell Count||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Cells/mm3||Standard Deviation|Mean
2851612|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 96||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851613|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 88||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851614|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 80||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851615|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 72||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851616|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 64||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851617|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 56||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851618|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 48||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851619|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 40||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851620|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 32||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851621|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 24||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Log(Copies/mL)||Inter-Quartile Range|Median
2851626|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 64|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851627|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 56|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851628|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 48|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851629|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 40|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851630|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 32|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851631|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 24|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851632|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 16|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851633|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 8|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851634|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 4|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851635|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 2|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851636|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851637|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2851638|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2851639|NCT00054717|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2851640|NCT00054717|Secondary|Treatment Response at Week 96|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851641|NCT00054717|Secondary|Treatment Response at Week 88|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851642|NCT00054717|Secondary|Treatment Response at Week 80|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851643|NCT00054717|Secondary|Treatment Response at Week 72|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851644|NCT00054717|Secondary|Treatment Response at Week 64|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851701|NCT00053989|Secondary|PFS|Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion|1 year||||percentage of participants||95% Confidence Interval|Number
2851645|NCT00054717|Secondary|Treatment Response at Week 56|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851646|NCT00054717|Secondary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851647|NCT00054717|Secondary|Treatment Response at Week 40|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851648|NCT00054717|Secondary|Treatment Response at Week 32|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851649|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851650|NCT00054717|Secondary|Treatment Response at Week 16|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851651|NCT00054717|Secondary|Treatment Response at Week 8|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Percentage of participants|||Number
2851652|NCT00054717|Secondary|Treatment Response at Week 4|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851653|NCT00054717|Secondary|Treatment Response at Week 2|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851654|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851655|NCT00054717|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||Days||Inter-Quartile Range|Median
2851656|NCT00054717|Primary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|At week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication|||percentage of participants|||Number
2851657|NCT00054704|Primary|Montgomery-Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of depression symptoms. Patients were rated weekly on 10 symptoms on a scale of 0 to 6 for each item, where 0 indicated no symptoms and 6 indicated the highest severity of that symptom. Total scores range from 0 to 60, where a moderate severity of depression would be present with a score of at least 20.|8 weeks|Data from all patients were included in the analysis, except for one riluzole patient with missing data.|||Units on a scale||Standard Error|Least Squares Mean
2851658|NCT00054691|Secondary|Duration of Response|Response duration was defined as the time from initial response during therapy to progression of disease.|Every 8 weeks till disease progression.|Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant.|||months||Full Range|Median
2851659|NCT00054691|Primary|Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)|Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease.|Every 8 weeks till disease progression.|Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.|||participants|||Number
2851660|NCT00054665|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|43 months||||Participants|||Number
2851698|NCT00054028|Primary|Percentage of Patients That Achieved Target Suramin Concentrations in Plasma|Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.|Up to 5 years||||percent of patients|||Number
2851661|NCT00054665|Primary|Clinical Response Rate|Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|18 weeks||||Participants|||Number
2851662|NCT00054639|Primary|Number of Patients With Objective Response|Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment|2 months following study treatment|Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.|||participants|||Number
2851663|NCT00054353|Secondary|Response Rate|Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates.|Up to 5 years||||Participants|||Count of Participants
2851664|NCT00054353|Secondary|Relapse Rate|Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates.|Up to 5 years||||Participants|||Count of Participants
2851665|NCT00054353|Secondary|Engraftment|Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion.|Up to 5 years||||Participants|||Count of Participants
2851666|NCT00054353|Secondary|OS|Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.|At 6 months and then every year thereafter, up to 5 years||||Participants|||Count of Participants
2851667|NCT00054353|Primary|Incidence of Chronic (Extensive) GVHD|Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.|Up to 5 years||||Participants|||Count of Participants
2851668|NCT00054353|Primary|Incidence of Acute GVHD (Grades III-IV)|Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.|Up to 5 years||||Participants|||Count of Participants
2851669|NCT00054353|Primary|Non-relapse Mortality|Early NRM will be monitored in a sequential fashion.|At day 100||||Participants|||Count of Participants
2851670|NCT00054353|Primary|PFS|PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.|At 1 year post-transplant|There were 4 patients who, although they did not have progression/relapse, died before the 1 year mark, and thus are not included in the 1 year PFS count.|||Participants|||Count of Participants
2851671|NCT00054327|Post-Hoc|Number of Patients With Overall Survival at 2 Years.||at 2 years from transplant||||participants|||Number
2851672|NCT00054327|Secondary|Toxicity as Measured by CTC v2.0|Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.|at 100 days post transplant||||participants|||Number
2851673|NCT00054327|Secondary|Incidence of Recurrent Disease|Number of patients that have disease recurrence.|at day 100 post transplant||||participants|||Number
2851674|NCT00054327|Secondary|Graft-versus-host Disease (GVHD)|Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.|at 100 days post transplant||||participants|||Number
2851675|NCT00054327|Primary|Rates of Durable Engraftment|Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support.|at day 42||||days||Standard Deviation|Mean
2851676|NCT00054275|Secondary|Overall Survival as of 2008|Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.|5 yrs|Including 10 patients with only 1 cycle of treatment|||months||95% Confidence Interval|Median
2851677|NCT00054275|Secondary|Progression Free Survival(PFS)|Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|3 years||||months||95% Confidence Interval|Median
2851678|NCT00054275|Primary|Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000|Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.|after 6 course (6 months) of combination therapy|Excluding 11 not evaluable cases|||participants|||Number
2851679|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGFR-2|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851680|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGF Receptor (VEGFR)-1|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851681|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for VEGF|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851682|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Tumor Protein p53 (p53)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851683|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Phosphorylated-v-akt Murine Thymoma Viral Oncogene Homolog 1 (Akt)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851684|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Phosphorylated-mitogen-activated Protein Kinase (MAP) Kinase|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851685|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for p27|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851686|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Marker of Proliferation Ki-67 (Ki-67)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851687|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for Human Epidermal Growth Factor Receptor 3 (HER3)|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851688|NCT00054132|Other Pre-specified|Percentage of Cells Staining Positive for EGFR|Associations between markers and tumor response will be assessed by logistic regression analysis. For those markers that are statistically significant, a cut-point analysis will be performed by the maximum chi-square with p-value adjustment method to determine positive values.|Up to 12 years|||||||
2851689|NCT00054132|Other Pre-specified|HER2 Status|Associations between response and HER2 will be assessed by Fisher's exact test.|Up to 12 years|||||||
2851690|NCT00054132|Secondary|Participants With Duration of Stable Disease Greater Than or Equal to 6 Months|Duration of stable disease greater than or equal to 6 months|From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years||||Participants|||Count of Participants
2851691|NCT00054132|Secondary|Number of Patients Evaluated for Toxicity|graded according to the National Cancer Institute Common Toxicity Criteria version 4.0|up to 12 years|Please see adverse events section.|||Participants|||Count of Participants
2851692|NCT00054132|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From the start of treatment until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years||||weeks||95% Confidence Interval|Median
2851693|NCT00054132|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).Evaluation of Target Lesions Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|From the time measurement criteria are met for CR and PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 12 years||||months|||Number
2851694|NCT00054132|Primary|Response Rate, Defined as Complete Response (CR) + Partial Response (PR), Using the Response Evaluation Criteria in Solid Tumors|Estimated at the end of the trial. Complete Response (CR):Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD 55 Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 12 years||||participants|||Number
2851695|NCT00054132|Primary|Level of EGFR Expression|"Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)~1+ - 3+ = positive:~faint immunoreactivity (weak staining)~intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics."|Up to 12 years||||participants|||Number
2851696|NCT00054028|Secondary|Response as Measured by RECIST Criteria|Evaluation of secondary endpoints will be primarily descriptive. Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Response rates will include 95% confidence limits.|Up to 5 years|Objective Response Rate|||percentage of patients|||Number
2851697|NCT00054028|Primary|Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 8 weeks||||patients|||Number
2851699|NCT00053989|Secondary|Acute GvHD|overall grade II-IV acute GvHD|Day +100|2 participants died before they were eligible for this outcome|||Participants|||Count of Participants
2851702|NCT00053989|Primary|Day 100 Best Response|Best disease response measured within 100 days from hematopoietic stem cell (HSC) infusion on day 0 using disease specific response criteria defined in the protocol|from start of conditioning on day -6 or -5 through day +100 after HSC infusion||||Participants|||Count of Participants
2851703|NCT00053989|Primary|Day 100 TRM|treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0|from start or conditioning (day -6 or -5) through day +100 after HSC infusion||||Participants|||Count of Participants
2851704|NCT00053898|Secondary|Quality-adjusted Survival Time|The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.|10 years||||months||95% Confidence Interval|Mean
2851705|NCT00053898|Secondary|Quality of Life-Short Form 12 (SF-12) Physical Health Component Score|The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.|5 years|The Quality of Life study was performed in a subset of B-35 participants. Participants were required to have submitted a baseline and at least one follow-up QOL form to be included in the analysis.|||units on a scale||Standard Deviation|Mean
2851706|NCT00053898|Secondary|Percentage of Patients Alive (Overall Survival)|Percentage of patients alive.|10 years|The analysis for overall survival included those whose method of contact for follow-up was by telephone.|||percentage of participants event-free|||Number
2851707|NCT00053898|Secondary|Percentage of Patients Alive and Disease-free|Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.|10 years||||percentage of participants event-free|||Number
2851708|NCT00053898|Secondary|Percentage of Patients Free From Osteoporotic Fractures|Percentage of patients free from fractures of the hip, spine, and wrist.|10 years|The analysis for osteoporotic fractures included those whose method of contact for follow-up was by telephone. Two participants were excluded from the analysis because their date of fracture was unknown.|||percentage of participants event-free|||Number
2851709|NCT00053898|Secondary|Percentage of Patients Free From Non-breast Secondary Cancer|Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.|10 years||||percentage of participants event-free|||Number
2851710|NCT00053898|Secondary|Percentage of Patients Free From Contralateral Breast Cancer|Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.|10 years||||percentage of participants event-free|||Number
2851711|NCT00053898|Secondary|Percentage of Patients Free From Ipsilateral Recurrence|Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.|10 years||||percentage of participants event-free|||Number
2851712|NCT00053898|Secondary|Percentage of Patients Free From Invasive Breast Cancer|Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.|10 years||||percentage of participants event-free|||Number
2851713|NCT00053898|Primary|Percentage of Patients Free From Breast Cancer|Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.|10 years||||percentage of participants event-free|||Number
2851714|NCT00053846|Primary|Dyspnea as Measured by Oxygen Cost Diagram (OCD)|OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.|28 days after beginning study drug or placebo||||units on a scale||Standard Deviation|Mean
2851715|NCT00053703|Secondary|Change From Baseline in Body Mass Index Change, kg/m2, at Week 8|Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||kg/m2||Standard Deviation|Mean
2851716|NCT00053703|Primary|Change From Baseline in PANSS Negative Symptom Subscale at Week 8|The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks||||units on a scale||Standard Deviation|Mean
2851717|NCT00053703|Primary|Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.|The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2851718|NCT00053703|Secondary|Change From Baseline in Barnes Akathisia Scale at Week 8|Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2851719|NCT00053703|Secondary|Change From Baseline in Weight at Week 8|change in weight from baseline to week 8 in kg|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||Kg||Standard Deviation|Mean
2851720|NCT00053703|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks|Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores > that 60 are considered clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2851721|NCT00053677|Primary|Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)|A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.|18 weeks||||units on a scale||Standard Deviation|Mean
2851722|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.|||x10-6th/μL||Standard Deviation|Mean
2851723|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.|||Percentage (%)||Standard Deviation|Mean
2851724|NCT00053495|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population|||Participants|||Number
2851725|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population|||mg/dL||Standard Deviation|Mean
2851726|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population|||IU/L||Standard Deviation|Mean
2851727|NCT00053495|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety, intent-to-treat population.|||Participants|||Number
2851728|NCT00053495|Primary|Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population.|||PRNT50 Titers||Standard Deviation|Mean
2851729|NCT00053495|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.|Days 0 to 30 post-vaccination|Adverse events were assessed in the safety, intent-to-treat population|||Participants|||Number
2851730|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population|||IU/L||Standard Deviation|Mean
2851731|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population|||mg/dL||Standard Deviation|Mean
2851732|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.|||x10^6th/µL||Standard Deviation|Mean
2851733|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.|||Percentage (%)||Standard Deviation|Mean
2851734|NCT00053482|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety intent-to-treat population.|||Participants|||Number
2851735|NCT00053482|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Post-vaccination adverse events were assessed in the safety, intent-to-treat population.|||Participants|||Number
2851736|NCT00053482|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination||||Participants|||Number
2851737|NCT00053482|Primary|The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)|Day 30 post-vaccination|The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.|||PRNT50 Titers||Standard Deviation|Mean
2851738|NCT00053417|Primary|Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test|The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).|Baseline (placebo run-in period); 12-week stable dose period||||percent change||Full Range|Median
2851739|NCT00053365|Secondary|Progression-free Survival|Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|From entry into study to death or date of last contact, assessed up to 5 years|Eligible and evaluable|||months||95% Confidence Interval|Median
2851740|NCT00053365|Primary|Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and evaluable patients|||participants|||Number
2851741|NCT00053365|Primary|Tumor Response|"Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death."|From entry into study until documented progression or death, assessed up to 5 years.||||participants|||Number
2851742|NCT00053352|Secondary|Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0|The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy|Up to 126 days after the start of chemotherapy|182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint|||patients|||Number
2851743|NCT00053352|Secondary|Days Hospitalized for Patients Who Receive Chemotherapy|Calculated to quantify the treatment cost associated with this regimen.|Up to 126 days after the start of chemotherapy|182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint|||Days in the hospital||Standard Deviation|Mean
2851744|NCT00053352|Primary|Overall Survival (OS)|Percentage probability of being alive at 3 years following enrollment.|3 Years after enrollment||||Percent Probability||95% Confidence Interval|Number
2851745|NCT00053352|Primary|Event-Free Survival (EFS)|Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.|3 Years after enrollment|181 patients were evaluated for event free survival through 3 years for patients enrolled on Arm 1. Event-free survival is not a primary outcome measure for Arm 2 patients.|||Percent probability||95% Confidence Interval|Number
2851746|NCT00053014|Secondary|Serious Adverse Events|Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.|9 months|All patients|||participants|||Number
2851747|NCT00053014|Primary|Overall Survival|measured from date of registration to study until death from any cause with patients still alive censored at date of last contact|1 year||||participants|||Number
2851748|NCT00003830|Secondary|Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.|Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|At time of surgery (within 30 days of randomization)|Data not collected for some patients. This analysis as pre-specified in the approved B-32 protocol required that both a SLN resection and an ALND be performed. The patients in Arm II were assigned to have no ALND so were excluded from the analysis.|||Participants|||Count of Participants
2851749|NCT00003830|Secondary|The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.|Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|At time of surgery (within 30 days of randomization)|Data missing or unknown for some patients. In Arm I, 19 patients did not accept the protocol and another 42 patients did not have a SLN resection leaving 2746 with a SLN resection. In Arm II, 4 declined the protocol treatment and another 10 patients did not have a SLN resection leaving 2790 with a SLN resection.|||Participants|||Count of Participants
2851750|NCT00003830|Secondary|Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence|Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|From the time of randomization until 5 years|Data missing or unknown for some patients|||percentage distant disease free at 5 yrs|||Number
2851751|NCT00003830|Secondary|Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence|Percentage of patients distant disease-free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.|From the time of randomization until 5 years|Data missing or unknown for some patients.|||percentage of patients|||Number
2851752|NCT00003830|Primary|Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.|Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.|8 years||||percentage pts disease free at 8 years||95% Confidence Interval|Number
2851808|NCT00047385|Secondary|T0 (Baseline) Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.|T0 (at study entry)|All participants randomized were analyzed.|||Participants|||Number
2851753|NCT00003830|Primary|Overall Survival|Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years|8 years|Data missing or unknown for some patients|||percentage of patients alive at 8 years||95% Confidence Interval|Number
2851754|NCT00003830|Primary|Morbidity - Number of Participants With Residual Arm Tingling|Morbidity as measured by residual arm tingling|before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients|||Participants|||Count of Participants
2851755|NCT00003830|Primary|Morbidity - Number of Participants With Residual Arm Numbness|Morbidity as measured by residual arm numbness|before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients|||Participants|||Count of Participants
2851756|NCT00003830|Primary|Morbidity - Number of Participants With Residual Arm Volume Difference|Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery|before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients.|||Participants|||Count of Participants
2851757|NCT00003830|Primary|Morbidity - Number of Participants With Residual Shoulder Abduction Deficit|Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.|Before and after surgery (within 30 days of randomization)|Data missing or unknown for some patients|||Participants|||Count of Participants
2851758|NCT00052962|Secondary|Number of Participants With an Adverse Event|Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.|2003-2008|Three participants were not included in the analysis because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.|||Participants|||Number
2851759|NCT00052962|Primary|Progression Free Survival|"CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter.~Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans."|2003-2008|Study was closed July 2008 because the PI left the institution, thus the objective was not met.||||||
2851760|NCT00052910|Secondary|Disease Free Survival|Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.|From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years||||years||95% Confidence Interval|Median
2851761|NCT00052910|Primary|Overall Survival|Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From study enrollment until death from any cause; up to 3 years||||years||95% Confidence Interval|Median
2851762|NCT00052715|Secondary|To Determine Tumor Response|Tumor response to treatment with Poly-ICLC|2 years|Data was not collected for this outcome measure due to reports of transient enlargement of contrast enhancing disease with subsequent shrinkage during Poly-ICLC treatment and the lack of central radiological review, the protocol defined criteria for radiological response could not be employed because of the risk of inconsistent results||||||
2851763|NCT00052715|Secondary|To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC|Descriptive measure per investigator to describe change in neurological status post-intervention.|1 year|Data was not collected for this outcome measure due to premature discontinuation of study agent in response to what turned out to be pseudo-progression.||||||
2851764|NCT00052715|Secondary|to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients|CTCAE 4|2 years||||participants|||Number
2851765|NCT00052715|Secondary|Determine the 12-month Survival Rate|12-month survival rate calculated from date of diagnosis|1 year||||percent of participants|||Number
2851766|NCT00052715|Secondary|To Determine 6 Months Progression Free Survival|Patients evaluated from date of diagnosis to the 6 month scan|6 months||||percentage of participants|||Number
2851767|NCT00052715|Primary|Overall Survival in Pts With Newly Diagnosed GBM|Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM|2 years|Four patents were censored for survival at 35, 114, 126, and 166 weeks|||weeks||95% Confidence Interval|Median
2851768|NCT00052429|Primary|Local Control of Participants|Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.|every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.||||percentage of participants|||Number
2851769|NCT00052429|Primary|Survival Rate of Patients|Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.|up to 77 months||||months||Full Range|Median
2851770|NCT00049543|Secondary|Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0|The incidence of toxicities will be summarized by type of adverse event and severity. A Fisher's exact test will be used to compare toxicities between the two arms.|Up to 5 years|All patients who received at least 1 dose of the treatment|||participants|||Number
2851771|NCT00049543|Secondary|Disease Free Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the disease free survival between two arms adjusting for the stratification factors. Five years disease free survival rate will be reported.|From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years|ITT population|||percentage of 5-year disease free rate||95% Confidence Interval|Number
2851829|NCT00046930|Primary|Overall Survival (OS)|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized|||Months||95% Confidence Interval|Median
2851772|NCT00049543|Primary|Overall Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.|From randomization to the time of death from any cause, assessed up to 5 years|ITT population|||percentage of 5 years survival rate||95% Confidence Interval|Number
2851773|NCT00049530|Secondary|Overall Survival|Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.|assessed every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated|||months||95% Confidence Interval|Median
2851774|NCT00049530|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients|||months||95% Confidence Interval|Median
2851775|NCT00049530|Secondary|Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)|"Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.~Non-progression rate = CR + PR + SD."|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2851776|NCT00049530|Primary|Plasma b-FGF Level Response|The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.|assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2851777|NCT00049517|Secondary|Overall Survival (Consolidation Phase)|Overall survival is defined as the time from randomization in the consolidation phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.|||Months||95% Confidence Interval|Median
2851778|NCT00049517|Primary|Disease-free Survival (Consolidation Phase)|Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.|||Months||95% Confidence Interval|Median
2851779|NCT00049517|Primary|Overall Survival (Induction Phase)|Overall survival is defined as the time from randomization in the induction phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.|All randomized patients are included in the analysis (intention-to-treat).|||months||95% Confidence Interval|Median
2851780|NCT00049504|Primary|Non-relapse-related Mortality|Number of deaths without progression or recurrence of malignant disease|Up to 200 days after transplantation||||Participants|||Count of Participants
2851781|NCT00049504|Primary|Incidence of Grades III-IV Acute GVHD|Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity|At any time within 200 days after transplantation||||Participants|||Count of Participants
2851782|NCT00049504|Primary|Donor Engraftment (Chimerism)|Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population|At day +84 after transplantation|Patients receiving haploidentical transplant who had T cell chimerism tested at day +84|||Participants|||Count of Participants
2851783|NCT00049322|Secondary|Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab||21 days after TACE||||fold change|||Number
2851784|NCT00049322|Secondary|Assess Pharmakokinetics of Bevacizumab in Liver Disease|bevacizumab serum concentrations|day 85||||micrograms/mL||95% Confidence Interval|Mean
2851785|NCT00049322|Secondary|Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment||16 weeks|subjects that completed all 16 weeks.|||participants|||Number
2851786|NCT00049322|Secondary|Progression Free Survival|Progression free survival (PFS) at 16 weeks (end of the core phase).|16 weeks|Arm I: Patients receive bevacizumab Arm II. Patients do not receive bevacizumab.|||probablility of pfs at 16 weeks|||Number
2851787|NCT00049322|Primary|Neovessel Formation as Measured by Angiogram at 14 Weeks|Angiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.|14 weeks||||participants|||Number
2851805|NCT00048997|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 12 months. Maximum follow-up at time of analysis was 96 months.|All eligible patients|||months||95% Confidence Interval|Median
2851788|NCT00049257|Secondary|Overall Survival Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Assessed every two months after completion of study treatment for 4 years||||participants|||Number
2851789|NCT00049257|Secondary|Objective Response Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Evaluated every 12 weeks during Treatment Period||||participants|||Number
2851790|NCT00049257|Primary|Time to PSA Progression|In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by >=5ng/ml, confirmed by a second value at >=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is >=5ng/ml and is confirmed by a second value at >=4 week intervals.|Evaluated every 28 days during Treatment Period||||days||Full Range|Median
2851791|NCT00049257|Primary|Prostate-specific Antigen (PSA) Response Rate|PSA response is defined as a decline from the baseline value of >=50% confirmed by a second PSA value 4 or more weeks later.|Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.||||participants|||Number
2851792|NCT00049127|Secondary|Overall Time to Death|Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.|Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years||||months||95% Confidence Interval|Median
2851793|NCT00049127|Secondary|Percentage of Patients Progression-free|"The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions.~Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years||||months||95% Confidence Interval|Mean
2851794|NCT00049127|Secondary|Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).|"Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance.~Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Up to 5 years||||percentage of confirmed responses|||Number
2851795|NCT00049127|Primary|6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.|"The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm.~Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|6 months||||percentage of patients|||Number
2851796|NCT00049036|Primary|Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment|Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma|60 days|ITT|||proportion|||Number
2851797|NCT00048997|Secondary|Number of Subjects With Central Nervous System (CNS) Metastases in the First Year|The presence of metastases were determined by computerized tomography (CT) of the brain with and without contrast or by magnetic resonance imaging (MRI) of the brain with and without gadolinium, using the same method that was done prior to study entry.|From randomization to one year (Scans given at 6 and 12 months and additionally at other times within the time frame if clinically indicated.)|Eligible patients|||Participants|||Count of Participants
2851798|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Communications Deficit From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain-20 (EORTC QLQ-B20) at One Year|"The EORTC QLQ-B20 is a 20-item self-report that assesses 11 symptom scales/items such as future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = not at all to 4 = very much. It is meant for use among brain cancer patients varying in disease stage and treatment modality (i.e. surgery, chemotherapy, radiotherapy, etc.) and should always be complemented by the QLQ-C30. The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. An increase from baseline to one year by >= 10 points was considered deterioration."|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-B20 communications deficit score|||percentage of participants||95% Confidence Interval|Number
2851806|NCT00047385|Secondary|T2 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.|T2 (two years after entry)|All participants randomized were analyzed|||Participants|||Number
2851799|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Future Uncertainty From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain-20 (EORTC QLQ-B20) at One Year|"The EORTC QLQ-B20 is a 20-item self-report that assesses 11 symptom scales/items such as future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = not at all to 4 = very much. It is meant for use among brain cancer patients varying in disease stage and treatment modality (i.e. surgery, chemotherapy, radiotherapy, etc.) and should always be complemented by the QLQ-C30. The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. An increase from baseline to one year by >= 10 points was considered deterioration."|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-B20 future uncertainty score|||percentage of participants||95% Confidence Interval|Number
2851800|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Fatigue From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year|"The EORTC QLQ is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. The QLQ Core-30 (QLQ-C30 ) is a 30-item self-report questionnaire that has patients rate the items on a 4-point scale, with 1 not at all to 4 very much and is composed of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0-100. A high score for a symptom scale/item represents a high level of symptomatology/problems. An increase from baseline to one year by >= 10 points was considered deterioration."|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-C30 cognitive fatigue score|||percentage of participants||95% Confidence Interval|Number
2851801|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Cognitive Functioning From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year|"The EORTC QLQ is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. The QLQ Core-30 (QLQ-C30 ) is a 30-item self-report questionnaire that has patients rate the items on a 4-point scale, with 1 not at all to 4 very much and is composed of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0-100. A high score for a functional status represents a high QOL. An increase from baseline to one year by >= 10 points was considered deterioration."|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-C30 cognitive functioning score|||percentage of participants||95% Confidence Interval|Number
2851802|NCT00048997|Secondary|Percentage of Subjects With Deterioration in Global Health Status From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year|"The EORTC QLQ is an integrated system for assessing the health-related quality of life (QOL) of cancer patients participating in international clinical trials. The QLQ Core-30 (QLQ-C30 ) is a 30-item self-report questionnaire that has patients rate the items on a 4-point scale, with 1 not at all to 4 very much and is composed of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The raw score is calculated as the mean of component items. This score is then standardized such that all of the scales and single-item measures range in score from 0-100. A high score for the global health status represents a high QOL. An increase from baseline to one year by >= 10 points was considered deterioration."|Baseline and one year from randomization|All eligible patients with a baseline and 12 month EORTC QLQ-C30 global health status score|||percentage of participants||95% Confidence Interval|Number
2851803|NCT00048997|Secondary|Percentage of Subjects With Deterioration in the Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recall Score at One Year|The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. The delayed recall part of the test involves memorizing a list of 12 targets and recalling them after a 20-minute delay. The raw score is derived by summing the number of targets correctly recalled and ranges from 0 to 12 with a higher score indicating better functioning. A patient was classified with deterioration if there was a statistically significant decrease in score from baseline to one year as determined by the method of reliable change index.|Baseline and one year post study entry|All eligible patients with a baseline and 12 month HVLT-R assessment.|||percentage of participants||95% Confidence Interval|Number
2851804|NCT00048997|Secondary|Percentage of Subjects With Deterioration in the Hopkins Verbal Learning Test - Revised (HVLT-R) Recall Score at One Year|The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. The recall part of the test involves memorizing a list of 12 targets for 3 consecutive trials for immediate recall. The raw score is derived by summing the number of targets correctly recalled and ranges from 0 to 36 with a higher score indicating better functioning. A patient was classified with deterioration if there was a statistically significant decrease in score from baseline to one year as determined by the method of reliable change index.|Baseline and one year post study entry|All eligible patients with a baseline and 12 month HVLT-R assessment.|||percentage of participants||95% Confidence Interval|Number
2851807|NCT00047385|Secondary|T1 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.|T1 (one year after entry)|All participants randomized were analyzed|||Participants|||Number
2851809|NCT00047385|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test.|Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If participant received 3 positive screens with documented follow-up after each one, he/she would be counted 3 times in the number of units analyzed.|||Pos. screens w/ complications|Participants||Number
2851810|NCT00047385|Secondary|Lung Cancer Diagnoses|Lung cancer diagnoses confirmed by medical record abstraction.|All events through December 31, 2009; median follow-up 6.5 years|All participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2851811|NCT00047385|Secondary|Deaths From All Causes in All Randomized Participants.|Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2851812|NCT00047385|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2851813|NCT00047320|Secondary|Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity|The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.|During chemotherapy(up to 18 weeks)|A total of 102 eligible patients treated with induction chemotherapy were included.|||participants||95% Confidence Interval|Number
2851814|NCT00047320|Secondary|Number of Patients Experiencing Toxic Death|Toxic death, defined as death predominantly attributable to treatment-related causes.|During chemotherapy (up to 18 weeks)|A total of 102 eligible patients treated with induction chemotherapy were included.|||Participants|||Count of Participants
2851815|NCT00047320|Secondary|Overall Survival (OS)|Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate.|At 3 years from study entry|Two ineligible patients were excluded. A total of 102 eligible patients were analyzed.|||Probability||95% Confidence Interval|Number
2851816|NCT00047320|Secondary|Progression-free Survival (PFS)|Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate.|At 3 years from study entry|Two ineligible patients were excluded. A total of 102 eligible patients were analyzed. one patient died without the disease progression reported. But the death was due to the disease. The death was counted as “event” when progression-free survival (PFS) was calculated. So EFS and PFS at 3 years were same.|||Probability||95% Confidence Interval|Number
2851817|NCT00047320|Secondary|The Probability of Event-free Survival (EFS)|Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate.|At 3 years from study entry|Two ineligible patients were excluded. A total of 102 eligible patients were analyzed.|||Probability||95% Confidence Interval|Number
2851818|NCT00047320|Primary|Response to Induction Chemotherapy|A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.|18 weeks|Of the 102 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used.|||Participants|||Count of Participants
2851819|NCT00047060|Primary|Efficacy of Nonmyeloablative Preparative Regimen|Proportion of subjects achieving a complete response|36 months|Received a nonmyeloablative preparative regimen of alemtuzumab 30mg iv 3x a week for 2 weeks followed by fludarabine 25mg/m2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x106 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially w/target CSA levels in the therapeutic range (200 -400 ng/ml).|||Participants|||Count of Participants
2851820|NCT00047008|Secondary|Correlation of COX-2 With Outcomes||From randomization to date of death or last follow-up|||||||
2851821|NCT00047008|Secondary|Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes||From randomization to date of death or last follow-up|||||||
2851822|NCT00047008|Secondary|Quality of Life||From randomization to 5 years|||||||
2851823|NCT00047008|Secondary|Rate of Grade 3-5 Toxicity||From start of treatment to last follow-up|||||||
2851824|NCT00047008|Secondary|Disease-free Survival|From randomization to date of failure (local or regional persistence/relapse, distant metastasis, secondary primary tumor or death) or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure|||||||
2851825|NCT00047008|Secondary|Local-regional Control|From randomization to date of failure (local or regional persistence/relapse) or death or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure|||||||
2851826|NCT00047008|Primary|Overall Survival (3-year Rate)|Time from randomization to death due to any cause or last known date alive. Median survival was not reached, therefore 3-year survival rates are reported.|From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.|Eligible patients who did not withdraw consent.|||percentage of patients||95% Confidence Interval|Number
2851827|NCT00046930|Secondary|Response|Number of eligible participants in each response category. Categories, based on peripheral blood counts and bone marrow aspirate and biopsy, include complete remission (CR), partial remission (PR), morphologic complete remission (MCR), and relapse.|Assessed at the end of induction||||Participants|||Number
2851828|NCT00046930|Secondary|Progression-free Survival (PFS)|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized. Patients who had neither documented progression nor death within 3 months of registration without disease evaluation were excluded.|||Months||95% Confidence Interval|Median
2853405|NCT00023595|Secondary|H02: All-cause Mortality||up to 5 years|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2851830|NCT00046891|Secondary|Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.|Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.|||Pearson correlation coefficient|||Number
2851831|NCT00046891|Secondary|Associations Between Self-reported Cognition and the HSCS.|Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.|||Pearson correlation coefficient|||Number
2851832|NCT00046891|Secondary|Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)|Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).|Baseline, 1st evaluation of post chemotherapy.|Secondary analyses uses all patients that reported data for baseline and post chemo visit.|||units on a scale||Standard Deviation|Mean
2851833|NCT00046891|Secondary|Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.|TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).|Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.|Secondary analysis uses all patients that reported baseline and at least one post baseline time point data.|||seconds||Full Range|Median
2851834|NCT00046891|Secondary|Median Scores for Trail Making Tests A and B (Lower Scores Are Better).|The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for all the time points.|||seconds||Full Range|Median
2851835|NCT00046891|Primary|The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.|The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.|Baseline, 12 months after starting Chemotherapy.|Efficacy analyses uses all patients that reported baseline and one value after baseline.|||units on a scale*months||Standard Deviation|Mean
2851836|NCT00046839|Primary|Overall Survival|Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|Eligible patients who started protocol treatment.|||years||95% Confidence Interval|Median
2851837|NCT00046839|Primary|Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)|"Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error).~Rating scale: 0 = not the MTD, 1 = MTD"|Start of treatment to 90 days|The first six eligible patients who started protocol treatment at each dose level.|||units on a scale|||Number
2851838|NCT00045734|Other Pre-specified|Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 years|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.||||||
2851839|NCT00045734|Other Pre-specified|Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens|insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue|- 3 years|insufficient samples to allow PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue||||||
2851840|NCT00045734|Other Pre-specified|Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.|5 years|Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.||||||
2851841|NCT00045734|Secondary|Determine Survival for Patients Treated With Imatinib Mesylate|survival determined from start of treatment to date of death|3 years|death date of 7 patients were unknown at time of analysis|||months||Full Range|Median
2851842|NCT00045734|Secondary|Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)|"Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1~result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8"|pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9|Only 14 samples available / evaluable for analysis|||ng/ml||Standard Deviation|Mean
2851843|NCT00045734|Secondary|Tumor Response as Assessed by MRI Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|Up to 5 years|response at first scan|||participants|||Number
2851844|NCT00045734|Secondary|Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0|percentage of patients who had grade 3 or grade 4 adverse events|Up to 5 years after completion of study treatment||||percentage of patients|||Number
2851845|NCT00045734|Secondary|Progression-free Survival According to Response Evaluation Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|3 years|Of the 22 eligible patients only 19 were evaluable for response|||months||Full Range|Median
2851846|NCT00045734|Primary|6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|At 6 months|Only 19 of the 23 patients were evaluable for response|||percentage of participants|||Number
2851847|NCT00045708|Secondary|Percent of Subjects With 6M Progression Free Survival at the Phase 2 Arm of Study|subjects who are progression free at 6 month scan|6 months|19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.|||percent of patients||95% Confidence Interval|Number
2851848|NCT00045708|Secondary|The Duration of Progression Free Survival (Phase 2)|only patients treated on the nonP450 MTD|1.5 years|19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.|||months||95% Confidence Interval|Median
2851849|NCT00045708|Secondary|Duration of Overall Survival||1.5 years||||months||95% Confidence Interval|Median
2851850|NCT00045708|Primary|Grade 3 and 4 Toxicity (NCI Common Terminology Criteria for Adverse Events Associated With BMS-247550 Treatment in at Least 5% of Patients|Proportion of patients with serious or life threatening toxicities in at least 5% of patients|Up to 30 days post treatment||||Participants|||Count of Participants
2851851|NCT00045708|Primary|Response Rate of Patients at the MTD|"Complete Response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable/improving neurologic exam for min4 wks.~Partial Response: Greater than or equal to 50% reduction in tumor size on volumetric MRI scan, on a stable/decreasing dose of glucocorticoids, with stable/improving neurologic examination for min 4 wks.~Progressive Disease: Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the volume of the tumor by MRI scan. If neurologic status deteriorates, on stable/increasing dose of steroids, or if new lesions appear on serial MRI, further study treatment will be discontinued.~Stable Disease: A patient whose clinical status and MRI volumetrics do not meet the criteria for Complete Response, Partial Response or Progressive Disease."|3 years|no objective responses observed. 19 patients treated at the MTD from during Phase 2 and 4 patients treated at the MTD during the Phase 1 nonP450 arm 2 were included in the response analysis.|||participants|||Number
2852000|NCT00036738|Primary|Relapse Free Survival|Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission.|Assessed up to 1 year||||Participants|||Count of Participants
2851852|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Volume of Distribution at Steady State as Related to BMS-247550 and Anticonvulsants|Vss = volume of distribution at steady-state (how widely distributed in the body the drug gets)|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set|||l/m2||Standard Deviation|Mean
2851853|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Clearance as Related to BMS-247550 and Anticonvulsant Measurements|CL = clearance (how much volume of blood is cleared of the drug per unIT of time|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set|||l/h/m2||Standard Deviation|Mean
2851854|NCT00045708|Primary|Measure Pharmacokinetic Parameters Using Estimation of Half-lives Related to BMS-247550 and Anticonvulsants|T1/2,z = terminal half-life (T1/2) --- for a 2 or 3 compartment drug, idea of how long drugs stick around|Course 1, Day 1 (pre-infusion, midpoint of infusion, 5min prior to end of infusion, 15min, 30min, 1hr, 2hr, 3hr, 4hr and 6hr post infusion|13 of the 21 samples for P450 collected day 1 sample set and 16 of the 17 samples for the nonP40 collected day 1 sample set|||h||Standard Deviation|Mean
2851855|NCT00045708|Primary|Group A (P450) Estimated MTD and Group B (nonP450) Estimated MTD of BMS-247550 in Patients With Recurrent or Progressive Malignant Glioma|Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC<500/ul, platelets<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.|21 days (1 cycle)||||mg/m2/day|||Number
2851856|NCT00045708|Primary|Number of Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) of BMS-247550 in Patients With Recurrent or Progressive Malignant Glioma|Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC<500/ul, platelets<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.|21 days (1 cycle)|4 subjects from Group B (Phase 1) were included in Group 3 (Phase 2). Only those on non-anticonvulsants at the dose of 6.8mg/m2/day were treated in Phase 2. No subjects treated at the MTD for P450, as the accrual goal for phase 2 reached before MTD for p450 was determined. P450 MTD determined as 9.6mg/m2 per CRM after all enrollment of phase 2|||DLTs|||Number
2851857|NCT00045630|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2851858|NCT00045630|Secondary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2851859|NCT00045630|Primary|Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy|Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.|up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2851860|NCT00045487|Primary|Number of Patients With Ani-tumor Activity After Taking OSI-774.|Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).|Disease progression or 52 weeks duration|Intent to treat analysis.|||participants|||Number
2851861|NCT00045435|Secondary|Incidence of Acute and Chronic GVHD|Percent patients with acute/chronic GVHD|aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.||||percentage of participants|||Number
2851862|NCT00045435|Secondary|Incidence of Rejection|Percent patients who developed infections post-transplant.|By 1 year after transplant||||percentage of participants|||Number
2851863|NCT00045435|Secondary|Incidence of Relapse|Percent patients with relapsed disease post-transplant.|By 1 year after transplant||||percentage of participants|||Number
2851864|NCT00045435|Secondary|Overall Survival|Percent patients surviving.|By 1 year after transplant||||percentage of participants|||Number
2851865|NCT00045435|Primary|Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death|Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%.|200 days after transplant||||percentage of participants|||Number
2851866|NCT00045435|Primary|Disease-free Survival-incidence of Survival Without Relapse|Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.|By 1 year after transplant||||percentage of participants|||Number
2851880|NCT00045110|Secondary|Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg-|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|AUC=area under the curve;|||ug * h/mL||Standard Deviation|Mean
2851867|NCT00045305|Secondary|Time to Engraftment for Platelet|Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients|||days||95% Confidence Interval|Median
2851868|NCT00045305|Secondary|Time to Engraftment for Neutrophil|Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients|||days||95% Confidence Interval|Median
2851869|NCT00045305|Secondary|Proportion of Graft Versus Host Disease|Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2851870|NCT00045305|Secondary|Overall Survival|Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients|||years||95% Confidence Interval|Median
2851871|NCT00045305|Secondary|Number of Patients Who Developed Disease Progression After Achieving Complete Response|Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients who achieved complete response|||participants|||Number
2851872|NCT00045305|Primary|Complete Response Rate|"Completed response is defined as:~Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation).~Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present"|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2851873|NCT00045162|Secondary|Number of Patients With a Given Type and Grade of Adverse Event.|Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.|Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.|Eligible patients who received protocol treatment.|||Participants|||Number
2851874|NCT00045162|Secondary|Confirmed and Unconfirmed Complete and Partial Responses.|Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.|Every 6 weeks while on protocol treatment for a maximum of 12 weeks||||participants|||Number
2851875|NCT00045162|Secondary|Progression-free Survival|Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.|Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.||||months||95% Confidence Interval|Median
2851876|NCT00045162|Primary|Overall Survival|Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.||||Months||95% Confidence Interval|Median
2851877|NCT00045110|Secondary|Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs|Drug administered 6 days prior to surgery|Pre-surgery and time of resection|sample 5 and 6 suspected of contamination with blood clot tumor/tissue concentration|||tumor/tissue concentration ng/g dry weig||Standard Deviation|Mean
2851878|NCT00045110|Secondary|Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs|Drug administered 6 days prior to surgery|Pre-surgery and time of resection|sample 5 and 6 suspected of contamination with blood clot|||plasma concentration ng/mL||Standard Deviation|Mean
2851879|NCT00045110|Secondary|Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|One sample on day 8 cycle 1|Cp=peak plasma concentration; tmax=time to Cp; AUC=area under the curve;|||ng/mL||Standard Deviation|Mean
2852060|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients||up to 2 years post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.|||participants|||Number
2851881|NCT00045110|Secondary|Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|tmax=time to peak plasma concentration;|||h||Standard Deviation|Mean
2851882|NCT00045110|Secondary|Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|Cpmax =peak plasma concentration;|||ng/mL||Standard Deviation|Mean
2851883|NCT00045110|Secondary|Trough Level Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|cycle 1 day eight|trough level|||ng/mL||Standard Deviation|Mean
2851884|NCT00045110|Secondary|Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|AUC=area under the curve|||ug* h/mL||Standard Deviation|Mean
2851885|NCT00045110|Secondary|Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5|Cp=peak plasma concentration;|||ng/mL||Standard Deviation|Mean
2851886|NCT00045110|Secondary|Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) -|plasma concentrations relative to erlotiniab administration and sample time and dose level|baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1.|tmax=time of peak plasma concentration|||h||Standard Deviation|Mean
2851887|NCT00045110|Secondary|Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II|Summarized by descriptive statistics.|Up to 1 year|drug related events grade 3-5 CTCAE. 5 patients were not evaluable for response/toxicity.|||percent of participants|||Number
2851888|NCT00045110|Secondary|Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II|"Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI~Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|At 1 year|recurrent malignant gliomas - anaplastic and glioblastoma|||participants|||Number
2851889|NCT00045110|Secondary|Overall Survival Newly Diagnosed GBM Post RT|Overall Survival defined as Time from Start of treatment to time of death due to any cause|2 years|not receiving Enzyme-inducing Antiepileptic Drugs, glioblastoma stable after RT|||months||95% Confidence Interval|Median
2851890|NCT00045110|Secondary|1 Year Survival - Phase II Newly Diagnosed GBM Post RT|12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT|At 1 year|not receiving Enzyme-inducing Antiepileptic Drugs; stable glioblastoma after RT|||% of participants|||Number
2851891|NCT00045110|Secondary|Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1|CTCAE|1 year|During Cycle 1 only grade 3 severity; patients on Enzyme-inducing Antiepileptic Drugs|||Participants|||Count of Participants
2851892|NCT00045110|Primary|6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)|Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|38 Glioblastoma, 15 anaplastic gliomas not receiving Enzyme-inducing Antiepileptic Drugs|||Participants|||Count of Participants
2851893|NCT00045110|Primary|Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts|standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|cycle 1 - 28 days|Cohorts/dose levels: 150mg; 200mg; 275mg; 400mg; 525mg; 650mg; 775mg patients on Enzyme-inducing Antiepileptic Drugs|||mg|||Number
2851894|NCT00045110|Primary|Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I|DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib.|28 days|Patients were eligible if they had recurrent disease or if they were newly diagnosed post RT and did NOT have tumor progression (nonprogression glioblastoma) on Enzyme-inducing Antiepileptic Drugs|||dose limiting toxicities|||Number
2851895|NCT00045032|Secondary|Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up|Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.|From Baseline until time of event (maximum up to 10 years)|Safety Population|||percentage of participants||95% Confidence Interval|Number
2851896|NCT00045032|Secondary|Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up|Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.|From Baseline until time of event (maximum up to 10 years)|Safety Population: All participants randomized/enrolled in the study according to actual treatment received. Hence, participants assigned to Herceptin who received no study treatment were analyzed in the Observation Arm.|||percentage of participants||95% Confidence Interval|Number
2851897|NCT00045032|Secondary|RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.|||percentage of participants||95% Confidence Interval|Number
2851898|NCT00045032|Secondary|Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.|||percentage of participants|||Number
2851899|NCT00045032|Secondary|DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
2851900|NCT00045032|Secondary|Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
2851901|NCT00045032|Secondary|DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851902|NCT00045032|Secondary|Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up|The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
2851903|NCT00045032|Secondary|TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
2851904|NCT00045032|Secondary|Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
2851905|NCT00045032|Secondary|TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851906|NCT00045032|Secondary|Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up|The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
2851907|NCT00045032|Secondary|DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
2851908|NCT00045032|Secondary|Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
2851909|NCT00045032|Secondary|DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851910|NCT00045032|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up|DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
2851911|NCT00045032|Secondary|RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
2851912|NCT00045032|Secondary|Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population 1Y2Y|||percentage of participants|||Number
2851913|NCT00045032|Secondary|RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851914|NCT00045032|Secondary|Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up|RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
2851915|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.|Years 3, 5, 7, 9, 10, 11, 12|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
2851916|NCT00045032|Secondary|Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 11 years)|FAS Population 1Y2Y|||percentage of participants|||Number
2851917|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.|Years 3, 5, 7, 9, 10, 11, 12|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851918|NCT00045032|Secondary|Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 11 years)|FAS Population|||percentage of participants|||Number
2851919|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Years 3, 5, 7, 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851920|NCT00045032|Secondary|Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
2851921|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
2851922|NCT00045032|Secondary|OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
2851923|NCT00045032|Secondary|Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
2851924|NCT00045032|Secondary|Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
2851925|NCT00045032|Secondary|DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Years 3, 5, 7, 8, 9, 10|FAS Population 1Y2Y|||percentage of participants||95% Confidence Interval|Number
2851926|NCT00045032|Secondary|Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (maximum of 10 years)|FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.|||percentage of participants|||Number
2851927|NCT00045032|Primary|DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 10|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851928|NCT00045032|Primary|DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 9|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851929|NCT00045032|Primary|DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851930|NCT00045032|Primary|DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 7|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851931|NCT00045032|Primary|DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 5|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851932|NCT00045032|Primary|DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.|Year 3|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851933|NCT00045032|Primary|Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (maximum of 10 years)|FAS Population|||percentage of participants|||Number
2851934|NCT00045032|Primary|DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 8|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851935|NCT00045032|Primary|DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 7|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851936|NCT00045032|Primary|DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 5|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851937|NCT00045032|Primary|DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.|Year 3|FAS Population|||percentage of participants||95% Confidence Interval|Number
2851938|NCT00045032|Primary|Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.|From Baseline until time of event (median of 8 years)|FAS Population|||percentage of participants|||Number
2851939|NCT00045032|Primary|DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
2851940|NCT00045032|Primary|DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|Year 2|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants||95% Confidence Interval|Number
2851941|NCT00045032|Primary|Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
2851980|NCT00040846|Secondary|Evaluate the Risk for Disease Progression and Relapse|Percentage patients who relapsed/progressed within 1 year post-transplant.|1 year after transplant|No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.|||percentage of participants|||Number
2851942|NCT00045032|Primary|Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up|DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.|From Baseline until time of event (median of 1 year)|"FAS Population. The Number of Participants Analyzed reflects the number with data for the endpoint."|||percentage of participants|||Number
2851943|NCT00042991|Secondary|Number of Patients With Epidermal Growth Factor Receptor (EGFR) Amplification|Epidermal growth factor receptor (EFGR) is a protein found on the surface of cells to which epidermal growth factor (EGF) binds. When EGF attaches to EGFR, it activates the enzyme tyrosine kinase, triggering reactions that cause the cells to grow and multiply.|Pre-treatment|Epidermal growth factor receptor is only possible with tumor sample, which is only potentially available from supratentorial malignant glioma patients treated on Stratum-1B and Stratum-2. Of 10 Stratum-1B and 3 Stratum-2 patients (n=13), tumor material was available from 11 patients (8 in Stratum-1A and 3 in Stratum-2).|||Participants|||Number
2851944|NCT00042991|Secondary|Gefitinib Area Under the Concentration Curve From 0-24 Hours (AUC)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||mcg/L*hr||Full Range|Median
2851945|NCT00042991|Secondary|Time of Maximum Clearance of Gefitinib (Tmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||Hour||Full Range|Median
2851946|NCT00042991|Secondary|Clearance of Gefitinib (Cl)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||L/hr/m2||Full Range|Median
2851947|NCT00042991|Secondary|Elimination Half Life of Gefitinib (t1/2)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||hour||Full Range|Median
2851948|NCT00042991|Secondary|Peak Serum Concentration of Gefitinib (Cmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.|||mcg/ml||Full Range|Median
2851949|NCT00042991|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.|||Ratio||Full Range|Median
2851950|NCT00042991|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.|||Ratio||Full Range|Median
2851951|NCT00042991|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Perfusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 20 patients had perfusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 20 patients.|||Ratio||Full Range|Median
2851952|NCT00042991|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Diffusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 29 patients had diffusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 29 patients.|||Ratio||Full Range|Median
2851981|NCT00040846|Secondary|Evaluate the Risk/Incidence of Infections|Percentage patients who experienced infections within 100 days post-transplant.|100 days after transplant|No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.|||percentage of participants|||Number
2851953|NCT00042991|Secondary|Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Volume enhancing is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, for only 19 patients, enhacing tumor was greater than zero based on brain MRI scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the enhancing volumetric data from these 19 patients.|||cc||Full Range|Median
2851954|NCT00042991|Secondary|Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. In this particular objective, the study aimed to investigate how radiation+gefitinib affect the tumor volume. Tumor volume is measured using Fluid Attenuated Inversion Recovery (FLAIR) before and after the radiation therapy.|Baseline and two weeks post completion of radiation|Out of 43 patients, 35 patients had brain MRI before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 35 patients.|||cc||Full Range|Median
2851955|NCT00042991|Primary|Median Survival in Newly Diagnosed Brain Stem Gliomas|Overall survival is defined as the interval from initiation of treatment to death or date of last contact for surviving patients|Assessed from the start of therapy until three years after initiation of gefitinib therapy||||Months||Full Range|Median
2851956|NCT00042991|Primary|Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas|Progression-free survival is defined as the interval from intiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurlogical status) or death for patients who failed or to the last date of follow-up for patients without failure|Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks|Here, we only report the results for Phase-II trial as this objective was specifically for the Phase-II trial. This cohort includes seven patients who were treated during Phase-I at Dose 250 mg/m^2 of Gefitinib.|||Months||Full Range|Median
2851957|NCT00042991|Primary|Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy|The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 patients had DLTs, then that dose level was considered to be too toxic.|Day 1 of gefitinib therapy to end of week 8|This cohort includes only the patients who were enrolled and treated on Gefitinib+Radiation during the Phase I component of the trial, where the safety of Gefitinib was assedded at Dose Levels 100 mg/m^2, 250 mg/m^2, and 375 mg/m^2.|||Participants|||Number
2851958|NCT00042939|Secondary|Proportion of Patients With Thromboembolic Events|To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered.|Assessed every 6 weeks while on treatment and for 30 days after the end of treatment|Eligible and treated patients|||Proportion of participants||90% Confidence Interval|Number
2851959|NCT00042939|Secondary|Epidermal Growth Factor Receptor (EGFR) Status|EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping.|Original tumor tissue samples submitted within one month of patient randomization|Eligible and treated patients with EGFR stain results available.|||participants|||Number
2851960|NCT00042939|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any cause.|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.|||months||90% Confidence Interval|Median
2851961|NCT00042939|Secondary|Progression-free Survival|"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occured within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.|||months||90% Confidence Interval|Median
2851962|NCT00042939|Primary|Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Assessed every 12 weeks until progression|Eligible patients who began treatment were included in the analysis.|||Proportion of participants||90% Confidence Interval|Number
2851963|NCT00041132|Secondary|Overall Survival|Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause.|assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years||||percentage of participants||95% Confidence Interval|Number
2851995|NCT00039130|Primary|Complete Response Rate|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|6 months||||percentage of participants||95% Confidence Interval|Number
2851996|NCT00036738|Secondary|Transplant-related Mortality|Number of patients with TRM within one year post-transplant.|At 1 year||||Participants|||Count of Participants
2851964|NCT00041132|Secondary|Response|Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD.|assessed after cycle 4 and after completion of treatment (168 days)||||participants|||Number
2851965|NCT00041132|Primary|Progression-free Survival|Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.|assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration||||percentage of participants||95% Confidence Interval|Number
2851966|NCT00041119|Secondary|Overall Survival (OS) for 4 vs. 6 Cycles|To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for overall survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.|from baseline up to 4 years|All patients that were eligible and received treatment were analyzed.|||percentage of patients at 4 years|||Number
2851967|NCT00041119|Secondary|Local Control|Local control will be calculated as the cumulative incidence of first local relapse.|from baseline up to 15 years|All patients that were eligible and received treatment were analyzed.|||years||Full Range|Median
2851968|NCT00041119|Secondary|Time to Distant Metastases|Local control and distant metastasis will be calculated as the cumulative incidence of first local relapse and first distant metastasis, respectively.|from baseline up to 15 years|All patients that were eligible and received treatment were analyzed.|||years||Full Range|Median
2851969|NCT00041119|Secondary|Adverse Events|To compare toxicities of short course CA and paclitaxel with long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. The percentage of patients that received a grade 3 or higher hematologic event will be reported here. We will be combining arm I with arm III, as well as arm II with arm IV. For a complete list of adverse events, please refer to the adverse events section.|from baseline up to 6 weeks post-treatment|3754 patients were considered evaluable for toxicity that occurred during treatment.|||percentage of patients|||Number
2851970|NCT00041119|Secondary|Overall Survival (OS)|To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for overall survival. OS will be measured from study entry until death due to any cause. Survivors will be censored at the date of last follow-up.. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.|from baseline up to 5 years|All patients that were eligible and treated for the study were evaluated.|||percentage of participants at 5 years|||Number
2851971|NCT00041119|Primary|Duration of Disease Free Survival (RFS)|To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. Objective progression is defined as the appearance of local (chest wall, axillary, supraclavicular nodes) or distant metastases. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.|from baseline up to 6.4 years|All eligible patients were treated and analyzed.|||months||95% Confidence Interval|Median
2851972|NCT00041119|Primary|Relapse Free Survival (RFS) 4 vs. 6 Cycles|To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.|from baseline up to 4 years|All patients that were eligible and received treatment were analyzed. 700 patients were not included due to the timing that the analysis was performed.|||years||Full Range|Median
2851973|NCT00041080|Primary|Median Progression-free Survival||from enrollment onto the study until first disease progression or death due to any cause||||months||95% Confidence Interval|Median
2851974|NCT00041067|Secondary|Toxicity|Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession|Eligible patients|||Participants|||Number
2851975|NCT00041067|Secondary|Progression-free Survival||2 years|All eligible patients|||months||95% Confidence Interval|Median
2851976|NCT00041067|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points.|response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession|patients with Response Evaluation Criteria in Solid Tumors measurable disease|||participants|||Number
2851977|NCT00041067|Primary|Survival at 1 Year||1 year|All eligible patients|||percentage of patients||95% Confidence Interval|Number
2851978|NCT00040937|Primary|Overall Survival||4-7 years||||proportion surviving at 4 years||95% Confidence Interval|Number
2851979|NCT00040937|Secondary|Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.|To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.|Induction|All participants receiving at least one dose of induction therapy|||Participants|||Number
2851982|NCT00040846|Primary|Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.|Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.|100 days after transplant|No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.|||percentage of participants|||Number
2851983|NCT00040846|Primary|Evaluate the Risk of Occurrence of Acute and Chronic GVHD|"Percentage patients who developed acute/chronic GVHD.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|1 year after transplant|No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.|||percentage of participants|||Number
2851984|NCT00040846|Primary|Evaluate the Risk of Transplant Related Mortality.|Percentage patients with Day 100 transplant related mortality.|100 days after transplant|No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.|||percentage of participants|||Number
2851985|NCT00040742|Secondary|Average Nausea Severity|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.~Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.~Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.|||units on a scale||Standard Error|Mean
2851986|NCT00040742|Primary|Change From Baseline of Peak Acute Nausea|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.~Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.~Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.|||units on a scale||Standard Deviation|Mean
2851987|NCT00039377|Secondary|5 Year Overall Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from registration|Participants who were on autologous or allogeneic transplant arms were analyzed (N=34).|||percentage of patients||95% Confidence Interval|Number
2851988|NCT00039377|Secondary|5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from CR|Participants who received autologous or allogeneic transplants were analyzed (N=34)|||percentage of patients||95% Confidence Interval|Number
2851989|NCT00039377|Primary|Disease Free Survival|"Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.~A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month."|Duration of treatment (up to 10 years)|One participant was excluded per study design as they did not achieve a complete remission. DFS Analysis was powered to include all patients.|||years||95% Confidence Interval|Median
2851990|NCT00039377|Secondary|Number of Participants Who Achieved a BCR-ABL Response at 12 Months|"BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).~Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene~MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally)."|12 months|Peripheral blood stem cells were assayed from 13 patients.|||participants|||Number
2851991|NCT00039377|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|OS Analysis was powered to include all participants.|||years||95% Confidence Interval|Median
2851992|NCT00039195|Primary|Progression Free Survival|Kaplan-Meier estimates will be used to verify the progression free survival.|2 years||||percentage of patients progression free||95% Confidence Interval|Number
2851993|NCT00039130|Secondary|2 Year Overall Survival|Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|2 years||||percentage of participants||95% Confidence Interval|Number
2851994|NCT00039130|Secondary|2 Year Event Free Survival|Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.|2 years||||percentage of participants||95% Confidence Interval|Number
2852001|NCT00033657|Secondary|Recurrence-free Survival Time|Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry||||Months||95% Confidence Interval|Median
2852002|NCT00033657|Secondary|Overall Survival Time|Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients|||Months||95% Confidence Interval|Median
2852003|NCT00033657|Primary|Pathologic Complete Response Rate|A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.|approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients|||percentage of participants||90% Confidence Interval|Number
2852004|NCT00033631|Secondary|Normal Tissue Complication Probability||From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.||2020-06-30|06/2020||||
2852005|NCT00033631|Secondary|Tumor Control Probability||From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.||2020-06-30|06/2020||||
2852006|NCT00033631|Secondary|Quality Adjusted Survival by SQLI||From randomization to 5 years.|This analysis will not be done because we are unable to find the required algorithm for converting SQLI scores into utilities, which is needed for quality adjusted survival analysis.||||||
2852007|NCT00033631|Secondary|Global Quality of Life (QOL) by Spitzer QOL Index (SQLI)||From randomization to 5 years.|||||||
2852008|NCT00033631|Secondary|Erectile Function by International Index of Erectile Function (IIEF)||From randomization to 5 years.|||||||
2852009|NCT00033631|Secondary|Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity|Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0|From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint|Eligible patients with acute adverse event data who did not withdraw consent.|||percentage of participants|||Number
2852010|NCT00033631|Secondary|Distant Metastases|Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent|||percentage of participants||95% Confidence Interval|Number
2852011|NCT00033631|Secondary|Local Progression|Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent|||percentage of participants||95% Confidence Interval|Number
2852012|NCT00033631|Secondary|Disease Specific Survival|Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.|From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2852013|NCT00033631|Secondary|Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition|Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.|From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.|All eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2852014|NCT00033631|Primary|Overall Survival|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.|All eligible patients who did not withdraw consent|||percentage of participants||95% Confidence Interval|Number
2852015|NCT00033540|Secondary|Median Survival Time for Participants With Relevant Biologic Markers|To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.|All patients will be followed until death or three years after registration, whichever is first.|Eligible patients who received genotyping were included in this analysis.|||months||95% Confidence Interval|Median
2852016|NCT00033540|Secondary|Accrual of Patients With This Disease Site|Only eligible patients who received treatment were evaluable for response and survival outcomes.|1-20 months|Patients with advanced disease accrued between September 2003 to April 2005|||participants|||Number
2852017|NCT00033540|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.|Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
2852018|NCT00033540|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|All patients will be followed until death or three years after registration, whichever is first.|All eligible patients who started treatment were included in assessing response estimates.|||months||95% Confidence Interval|Median
2852019|NCT00033540|Primary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|All eligible patients who started treatment were included in assessing response estimates.|||participants|||Number
2852020|NCT00033514|Primary|Recommended Dose for Phase II||treatment period|patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.|||participants receiving each dose|||Number
2852021|NCT00033514|Secondary|Serum Concentration of Herceptin at Specified Time-points.||4 months||||mcg/mL||95% Confidence Interval|Mean
2852022|NCT00033514|Secondary|Incidence of Adverse Events||5 years|subjects evaluated for SAEs|||participants affected by SAEs|||Number
2852023|NCT00033514|Secondary|Duration of Objective Response||5 years|Subjects that achieved objective response (4). All were from phase II.|||participants|||Number
2852024|NCT00033514|Primary|The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.|"Complete Response:~The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.~Partial Response:~A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission."|5 years|12 patients with measurable disease and no prior trastuzumab in the metastatic setting considered evaluable at the recommended phase II dose level. 2 from phase 1 and 10 from phase 2 Excluded : 14 from Phase I: no measureable disease or previous trastuzumab. Phase II: Withdrawn due to disease complications|||participants|||Number
2852025|NCT00033371|Secondary|Percent Change in the Area of Plaque-like Duodenal Polyps|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment|||||||
2852026|NCT00033371|Secondary|Change in Global Colorectal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment|||||||
2852027|NCT00033371|Secondary|Percent Change in Polyp Size in Focal Area(s) of the Colorectum|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment|||||||
2852028|NCT00033371|Secondary|Global Duodenal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Up to 2 months after completion of study treatment|||||||
2852029|NCT00033371|Primary|Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum|Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie [(6 months - baseline) x 100]/baseline (%). For each participant, first were matched polyps between baseline & 6 months by region and landmark and summed over all matched regions on number of polyps >2 mm to calculate total number of polyps >2 mm at baseline & 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline & 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.|Baseline up to 6 months|Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information.|||percentage change in polyp count||Standard Error|Mean
2852030|NCT00033293|Secondary|Tumor Outcome in Terms of Overall Survival (OS) Rate|OS rate from time of study enrollment.|Up to 3 years|All eligible randomized patients.|||3 year OS||95% Confidence Interval|Number
2852031|NCT00033293|Secondary|Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death|EFS rate for neuroblastoma event from time of study enrollment.|Up to 3 years|All eligible randomized patients.|||3 year EFS||95% Confidence Interval|Number
2852032|NCT00033293|Secondary|Long-term Prognosis for Neurologic Recovery by Neurological Examination|A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.|At diagnosis and yearly for 10 years after diagnosis|The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.||||||
2852033|NCT00033293|Secondary|Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology|Descriptive analyses on biologic variables will be performed|At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis|The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.||||||
2852034|NCT00033293|Secondary|Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing|"The Bayley Scales of infant development mental scale best score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline."|Changes from baseline to the better of 6 months or 1 year|All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year.|||Change in Bayley's score||Standard Deviation|Mean
2852035|NCT00033293|Secondary|Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)|"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated."|Changes from baseline to the better of 6 months or 1 year|All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.|||Change in VABS score||Standard Deviation|Mean
2852036|NCT00033293|Primary|Number of Responders|A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.|Changes from baseline to 2 months, 6 months, and 1 year|Eligible patients|||participants|||Number
2852037|NCT00031694|Secondary|Bryostatin 1 Pharmacokinetics||Week 1|||||||
2852038|NCT00031694|Secondary|Overall Survival|Computed using the Kaplan-Meier estimator.|Up to 8 years|||||||
2852039|NCT00031694|Secondary|Adverse Events|95% confidence intervals will be computed and presented.|Up to 8 years|||||||
2852040|NCT00031694|Primary|Response Rate of at Least 30%|Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 8 years||||participants|||Number
2852041|NCT00031590|Secondary|Long Term Survival|"Survival Endpoints:~Event free survival and overall survival were assessed at 5 years from time of study enrollment"|Up to 5 years from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.|All subjects who received radiation and started chemotherapy.|||Percentage of participants|||Number
2852042|NCT00031590|Primary|Evaluate Rate of Late Neurotoxic Effects|Evaluate the late neurotoxic effects of low dose craniospinal radiation, including neurocognitive decline as measured by serial neurocognitive testing.|3 years|The primary endpoint was not met due to lack of evaluable data from non-compliance with neurocognitive testing. Baseline neurocognitive testing was performed on 5 of 28 (18%) of study subjects. Of those 5 subjects with baseline testing, only 1 completed follow up neurocognitive testing at the protocol specified time points.||||||
2852043|NCT00030901|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|3 months after randomization and then every 3 months for 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2852044|NCT00030901|Primary|Presence of Carcinoma of the Prostate as Measured by Biopsy|The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.|3 years|All eligible randomized patients who started treatment and have prostate cancer known through an interim biopsy or a biopsy taken at +/- 90 days of the end of study were included in the analysis.|||participants|||Number
2852045|NCT00030823|Primary|Safety|By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.|2 years|All 13 participants experienced toxicities.|||participants|||Number
2852046|NCT00030264|Primary|Time to Disease Progression|"Disease progression was assessed both radiographically and clinically.~Tumor assessments to assess for radiographic disease progression were assessed by magnetic resonance imaging (MRI) measurement whenever possible or computed tomography (CT) scan and/or tumor measurement during physical examination of palpable lesions. Clinical assessments for clinical progression of disease were assessed by treating physician or designee.~Progressive disease as measured by the appearance of new lesions; an increased size of index tumor(s) by >/= 25% of the sum of the products of baseline measurements; and/or by increase in symptoms."|6 months|20 subjects were analyzed for time to progression. 3 subjects were not included in the response analysis due to lost to follow up (N=2) or progression of comorbid condition which required early termination (N=1)|||Months||Full Range|Mean
2852047|NCT00028769|Primary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-5 years|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
2852048|NCT00028769|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 5 years after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2852049|NCT00028769|Primary|Progression-free Survival|Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.|0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)|All eligible patients who started treatment were included in the analysis|||months||95% Confidence Interval|Median
2852050|NCT00028002|Secondary|FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy|"evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax <1 indicate decreased tumor metabolism while values >1 indicated an increase in tumor metabolism.~Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD."|change from baseline to 1 week post therapy||||percentage change in SUVmax||Full Range|Mean
2852051|NCT00028002|Secondary|Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)|Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.|Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.|All eligible patients who started study treatment (for pre-surgery), and who additionally had surgery (post-surgery)|||percentage of participants||95% Confidence Interval|Number
2852052|NCT00028002|Secondary|Rates of Objective Response (Complete, Partial, and Stable)|The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf.|Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
2852053|NCT00028002|Primary|Rate of Disease Progression at 2 Years|Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf|From registration to two years|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
2852054|NCT00027846|Secondary|Local Control and Patterns of Failure|Documented and analyzed qualitatively and quantitatively.|Up to 5 years after completion of study treatment|All eligible patients in the study were included.|||Participant|||Number
2852055|NCT00027846|Secondary|Event-free Survival (EFS)|EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.|At 5 years since the time of radiation therapy|Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.|||Probability of EFS at 5 years||95% Confidence Interval|Number
2852056|NCT00027846|Secondary|Event-free Survival (EFS)|EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.|At 5 years since the time of radiation therapy.|Of 64 eligible patients who had initial subtotal resection, 5 patients were off-therapy prior to radiation therapy, and 4 patients had a disease progression prior to radiation therapy. There were 55 eligible patients included in the analysis. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.|||Probability of EFS at 5 years||95% Confidence Interval|Number
2852057|NCT00027846|Secondary|Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy|The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.|At the time of second surgery|Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.|||percentage of participants||95% Confidence Interval|Number
2852058|NCT00027846|Secondary|Overall Survival|Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.|Up to 5 years after completion of study treatment|All eligible patients in the study were included. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability.|||Probability of OS at 5 years||95% Confidence Interval|Number
2852059|NCT00027846|Primary|Event-free Survival|Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.|Up to 5 years after completion of study treatment|The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.|||Probability of EFS at 5 years||95% Confidence Interval|Number
2852062|NCT00027560|Secondary|Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.|||participants|||Number
2852063|NCT00027560|Primary|Acute Graft-versus-Host Disease Matched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of matched related patients was analyzed as per protocol.|||participants|||Number
2852064|NCT00027560|Primary|Overall Survival||24 months post transplant|Population is defined as all participants who received transplant as per protocol.|||participants|||Number
2852065|NCT00027560|Primary|Overall Survival||12 months post transplant|Population is defined as all participants who received transplant as per protocol.|||participants|||Number
2852066|NCT00026494|Primary|Radiographic Response Assessed by Macdonald Criteria Every 2 Months|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.|2 years||||participants|||Number
2852067|NCT00026312|Other Pre-specified|Presence of Naturally Occurring Anti-glycan Antibodies|A Fisher's exact test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions. A Wilcoxon test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with blood levels of dinutuximab.|Up to 10 years|||||||
2852068|NCT00026312|Other Pre-specified|NKp30 Isoform Expression and SNP|Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.|1 week before first sargramostim injection (day -1 of course 1)|||||||
2852069|NCT00026312|Other Pre-specified|Levels of ADCC|Will be descriptively compared.|Up to 10 years|||||||
2852070|NCT00026312|Other Pre-specified|Isotretinoin Pharmacokinetic Parameters|To determine if there is a relationship of the peak serum concentration level with EFS, the term for this level will be tested in a Cox proportional hazards model. To determine if there is a relationship of the peak serum concentration level with toxicity rates, Kendall's Tau statistic will be calculated.|At 4 hours after administration on day 14 of course 1|||||||
2852071|NCT00026312|Other Pre-specified|Genotype of Kir/Kir-ligand|Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.|Up to 10 years|||||||
2852072|NCT00026312|Other Pre-specified|Genotype of FcR|Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.|Up to 10 years|||||||
2852073|NCT00026312|Other Pre-specified|Circulating B7-H6 Levels|Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.|1 week before first sargramostim injection (day -1 of course 1)|||||||
2852074|NCT00026312|Other Pre-specified|Change in Tumor Biology|A multivariate Cox proportional hazards regression model will test to see if the dinutuximab serum level, HACA titer, effector cell function, or serum marker for effector cell activation are associated with EFS or OS.|Baseline to up to 10 years|||||||
2852075|NCT00026312|Other Pre-specified|Change in MRD|A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS.|Baseline to up to 10 years|||||||
2852076|NCT00026312|Other Pre-specified|Cardiac Repolarization|In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate.|Up to 10 years|||||||
2852077|NCT00026312|Other Pre-specified|Average Level of HACA|The average level of HACA at each collection time point during immunotherapy will be calculated.|Up to 10 years|||||||
2852078|NCT00026312|Secondary|Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial|OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.|Three years|Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease|||Percentage of participants||95% Confidence Interval|Number
2852079|NCT00026312|Secondary|Overall Survival (OS)|Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.|Three years|Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.|||Percentage of participants||95% Confidence Interval|Number
2852080|NCT00026312|Secondary|Number of Courses of Therapy Delivered|Number of courses of therapy delivered for patients randomized to RA + Immunotherapy vs. patients non-randomly assigned to RA + Immunotherapy, excluding patients with persistent disease.|Courses 1-6|Eligible patients assigned to Regimen B, excluding patients with persistent disease.|||courses per patient||Full Range|Median
2852081|NCT00026312|Secondary|Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0|Proportion of patients experiencing at least one Grade 3 or higher toxicity.|From enrollment to follow-up|Eligible patients enrolled prior to halting of randomization.|||Proportion||95% Confidence Interval|Number
2852082|NCT00026312|Secondary|Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial|EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.|Three years|Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.|||Percentage of participants||95% Confidence Interval|Number
2852083|NCT00026312|Secondary|Event-Free Survival (EFS)|Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.|Three years|Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.|||Percentage of participants||95% Confidence Interval|Number
2852084|NCT00026312|Primary|Event-Free Survival (EFS)|Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only|Three years|Eligible, randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2852085|NCT00026221|Secondary|New Vessel Formation in Patient Tumor Samples|Evaluated using immunohistochemistry.|Up to 2 years|Data were not collected and not assessed.||||||
2852086|NCT00026221|Secondary|Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa|Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.|At baseline||||pg/mL||Full Range|Median
2852087|NCT00026221|Primary|Progression-free Survival|Defined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years||||months||Full Range|Median
2852088|NCT00026221|Other Pre-specified|Toxicity|Evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria version 2.0.|Continuously from the start of treatment to the end of study|||||||
2852089|NCT00026221|Primary|Objective Response Rate|Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 2 years||||patients|||Number
2852090|NCT00026208|Secondary|Survival at 5 and 10 Years|Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.|5 and 10 years|For overall survival at 5 and 10 years, this analysis does not include those participants known to be alive, but whose diagnosis was less than 5 or 10 years prior to current date or last date known alive, respectively.|||Participants|||Count of Participants
2852091|NCT00026208|Secondary|Overall Survival (OS)|Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.|16 years|Includes all participants, except those whose treatment was significantly modified due to accidental injury. Subjects who became lost-to-follow-up were censored at their last known value.|||years||Full Range|Median
2852092|NCT00026208|Secondary|Second Hodgkin's Disease Progression|Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis.|16 years|Data to confirm Hodgkin's disease 2nd progression was not available for some participants.|||Participants|||Count of Participants
2852093|NCT00026208|Secondary|Late Treatment-related Toxicity|Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis.|16 years||||treatment-related adverse events|||Number
2852094|NCT00026208|Secondary|Early Treatment-related Toxicity|Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment.|Within 30 days of treatment||||treatment-related adverse events|||Number
2852095|NCT00026208|Secondary|Frequency of Complete Response|"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)."|5 weeks|Participants, for whom a PET-CT scan was not conducted in week 4 to 5 of treatment, were not included.|||Participants|||Count of Participants
2852096|NCT00026208|Primary|Progression-free Survival (PFS)|Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.|up to 3 years|Does not include those participants whose treatment was significantly modified due to accidental injury; or who were lost-to-follow-up.|||percentage of participants|||Number
2852097|NCT00025662|Other Pre-specified|Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.||100 days from transplant|All 22 patients who received the selectively depleted transplant|||percentage of participants|||Number
2852098|NCT00025662|Other Pre-specified|Acute GVHD (Any Grade) Using the CIBMTR Grading System.|Proportion of patients with acute GVHD, grade 1 to 4|100 days from transplant|All 22 subjects who received the selectively depleted transplant|||percentage of participants||95% Confidence Interval|Number
2852099|NCT00025662|Secondary|Cumulative Non Relapse Mortality|Percent non relapse mortality (actuarial) at analysis in Dec 2011|Dec 2011.|All patients who received the selectively depleted transplant|||percentage of participants||95% Confidence Interval|Number
2852100|NCT00025662|Secondary|Overall Survival|Percent overall survival (actuarial) at analysis in Dec 2011.|Dec 2011.|all patients who received the selectively depleted transplant including one special exemption|||percentage of participants||95% Confidence Interval|Number
2852101|NCT00025662|Primary|Treatment-related Mortality|"Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects.~This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011."|100 days after stem cell infusion|all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria|||percentage of participants||95% Confidence Interval|Number
2852102|NCT00025506|Other Pre-specified|Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF||Up to 5 years|||||||
2852103|NCT00025506|Other Pre-specified|Serum and Plasma Concentrations of VEGF and bFGF With PFS||Up to 5 years|||||||
2852104|NCT00025506|Secondary|Initial Histologic Grade|G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.|Baseline|Eligible and evaluable patients|||Participants|||Count of Participants
2852105|NCT00025506|Secondary|Initial Performance Status|"Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction.~Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.~Performance status 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours."|baseline|Eligible and evaluable patients|||Participants|||Count of Participants
2852106|NCT00025506|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
2852107|NCT00025506|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. (average = 4 months)|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2852108|NCT00025506|Secondary|Progression Free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle until progression or death, up to 5 years.|Eligible and treated patients|||months||Inter-Quartile Range|Median
2852109|NCT00025506|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0||Each cycle during treatment and 30 days after the last treatment (average 4 months)|Eligible and evaluable patients|||Participants|||Count of Participants
2852110|NCT00025506|Primary|Progression-free Survival (PFS) > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2852111|NCT00025259|Secondary|Overall Survival|Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.|5 years|Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Probability of survival||95% Confidence Interval|Number
2852112|NCT00025259|Secondary|Grade 3 or 4 Non-hematologic Toxicity|Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.|Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Number of participants|||Number
2852113|NCT00025259|Secondary|Disease Response Assessed by Modified RECIST Criteria|Number of participants with complete response and very good partial response at the end of protocol therapy.|Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Number of participants|||Number
2852114|NCT00025259|Primary|Event-free Survival|Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.|5 years|Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).|||Probability of survival||95% Confidence Interval|Number
2852115|NCT00025233|Secondary|Age at Enrollment||Baseline|Eligible and treated patients|||Participants|||Count of Participants
2852116|NCT00025233|Secondary|Performance Status|Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Baseline|Eligible and treated patients.|||Participants|||Count of Participants
2852117|NCT00025233|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2852118|NCT00025233|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
2852119|NCT00025233|Secondary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2852120|NCT00025233|Primary|Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0|The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.|Every cycle and 30 days after the end of treatment. (average 5 months)|Eligible and treated patients|||Participants|||Count of Participants
2852121|NCT00025233|Primary|Progression-free Survival Greater Than 6 Months|Whether or not the patient survived progression-free for at least 6 months.|Every other 3-week treatment cycle for 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2852122|NCT00025155|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated participants.|||Months||95% Confidence Interval|Median
2852123|NCT00025155|Secondary|Progression Free Survival|"Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.~Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression."|From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up|Eligible and treated participants.|||Months||95% Confidence Interval|Median
2852124|NCT00025155|Primary|Number of People With Adverse Effects||Every cycle until completion of study treatment up to 30 days after stopping study treatment|Eligible and treated patients|||Participants|||Count of Participants
2852125|NCT00025155|Primary|Tumor Response|"Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval.~Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation."|Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.|Eligible and treated participants.|||percentage of participants||90% Confidence Interval|Number
2852126|NCT00024258|Primary|Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment||1 year||||participants|||Number
2852127|NCT00024167|Secondary|Overall Survival From Registration|Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from registration until death, up to 7 years.||||months||95% Confidence Interval|Median
2852128|NCT00024167|Primary|Overall Survival From Randomization|Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from randomization until death, up to 7 years.||||months||95% Confidence Interval|Median
2852345|NCT00004092|Secondary|Five-Year Overall Survival|Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five Years||||percentage of participants||95% Confidence Interval|Number
2852129|NCT00024102|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Reported during protocol treatment after each cycle||||participants|||Number
2852130|NCT00024102|Secondary|Overall Survival Rate at 2.4 Years|Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.|Time from registration to death (up to 15 years)|OS used the intent-to-treat approach.|||percentage of participants|||Number
2852131|NCT00024102|Primary|Relapse-free Survival Rates at 2.4 Years|"Percentage of participants who were alive and relapse-free at time of analysis were counted as Alive without relapse at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as relapse, first occurrence. These rates were estimated using the Kaplan Meier method"|randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)|RFS used the intent-to-treat approach|||percentage of participants|||Number
2852132|NCT00023764|Primary|Response Rate|The response probability will be estimated. The 95% confidence interval will be provided.|Up to 3 years||||participants|||Number
2852133|NCT00023712|Secondary|Progression-Free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|From study entry up to 5 years||||months||95% Confidence Interval|Median
2852134|NCT00023712|Secondary|Overall Survival||From study entry, up to 5 years following disease progression||||months||95% Confidence Interval|Median
2852135|NCT00023712|Primary|Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.|From study entry until disease progression/intolerable toxicity/study withdrawal||||participants|||Number
2852136|NCT00023712|Primary|Frequency and Severity of Observed Adverse Events||Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
2852137|NCT00023712|Primary|Tumor Response Duration|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|From study entry, up to 5 years||||months||Full Range|Median
2852138|NCT00022698|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths|An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Approximately 43 Months|The Safety Population consisted of all participants who received at least 1 dose of any study drug and had at least one post-baseline safety assessment. This included participants in Cohort 1 and Cohort 2.|||Number of participants|||Number
2852139|NCT00022698|Secondary|Duration of Overall Complete Response|The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.|||months|||Number
2852140|NCT00022698|Secondary|Duration of Overall Response|Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.|||months||95% Confidence Interval|Median
2852141|NCT00022698|Secondary|Time To Objective Response|The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
2852142|NCT00022698|Secondary|Overall Survival|Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
2852143|NCT00022698|Secondary|Percentage of Participants With One-year Survival|Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.|Up to Month 12|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||percentage of participants||95% Confidence Interval|Number
2852144|NCT00022698|Secondary|Time to Treatment Failure|Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
2852145|NCT00022698|Secondary|Time to Disease Progression|Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||months||95% Confidence Interval|Median
2852146|NCT00022698|Primary|Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)|Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.|||percentage of participants|||Number
2852147|NCT00022672|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.|Throughout the Study (Up to 5 years)|Safety population included all participants who received at least one dose of study drug.|||Participants|||Number
2852148|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|End of Study (Up to 5 years)|Full Analysis Population includes all randomized participants who received study drug.|||Percentage of participants|||Number
2852149|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|End of Study (Up to 5 years)|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.|||Percentage of participants|||Number
2852150|NCT00022672|Secondary|Time to Response at End of Study|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
2852151|NCT00022672|Secondary|Duration of Response at End of Study|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
2852152|NCT00022672|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline|"Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.~The percentage of participants in the following categories:~Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline."|Baseline, Final Visit (Up to 24 Months)|Participants from the Full Analysis Population (includes all randomized participants who received study drug) with data available for analyses.|||Percentage of participants|||Number
2852153|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.|||Percentage of participants|||Number
2852154|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.|||Percentage of participants|||Number
2852155|NCT00022672|Secondary|Percentage of Participants With Two-Year Survival||24 Months|Full Analysis Population included all randomized participants who received study drug.|||Percentage of participants|||Number
2852157|NCT00022672|Secondary|Time to Response at 24 Months|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
2852158|NCT00022672|Secondary|Duration of Response at 24 Months|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.|||Months||Full Range|Median
2852159|NCT00022672|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.|24 Months, End of Study (Up to 5 years)||||Percentage of participants|||Number
2852160|NCT00022672|Primary|Progression Free Survival (PFS)|PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.|24 Months, End of Study (Up to 5 years)|Full analysis population included all randomized participants who received study drug.|||Months||95% Confidence Interval|Median
2852161|NCT00022659|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.|Eligible and treated patients|||months||Inter-Quartile Range|Median
2852162|NCT00022659|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
2852163|NCT00022659|Primary|Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.|Eligible and evaluable patients|||Participants|||Count of Participants
2852164|NCT00022659|Primary|Tumor Response|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2852165|NCT00022659|Primary|Progression-free Survival at 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months.|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
2852166|NCT00022633|Secondary|Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||percentage of participants|||Number
2852176|NCT00022516|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
2852214|NCT00016913|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.|registration to progression, up to 5.5 years from registration|All 27 evaluable patients were used in this analysis|||months||95% Confidence Interval|Median
2852167|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||minutes||Full Range|Median
2852168|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||percentage of participants|||Number
2852169|NCT00022633|Primary|Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols|Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.|66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)|A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.|||participants|||Number
2852170|NCT00022633|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.|Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded|||Participants|||Number
2852171|NCT00022633|Secondary|Overall Survival (OS) in Patients Aged 70 Years and Older|Measured from date of registration to date of death due to any cause.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||months||95% Confidence Interval|Median
2852172|NCT00022633|Secondary|Progression-free Survival in Patients Aged 70 Years and Older|Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||months||95% Confidence Interval|Median
2852173|NCT00022633|Secondary|Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)|Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|every week for the first 4 weeks and then every 3 weeks for up to 19 weeks|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2852174|NCT00022516|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
2852175|NCT00022516|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
2852177|NCT00022516|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)|||percentage of participants||95% Confidence Interval|Number
2852178|NCT00022490|Secondary|The Rate of Complete Hematologic Responses at 6 and 12 Months||6 and 12 months|||||||
2852179|NCT00022490|Secondary|The Rate of Minor Cytogenetic Responses at 6 and 12 Months||6 and 12 months|||||||
2852180|NCT00022490|Secondary|The Rate of Complete and Major Cytogenetic Responses at 12 Months||12 months|||||||
2852181|NCT00022490|Secondary|The Rate of Complete Cytogenetic Response at 6 Months||6 months|||||||
2852182|NCT00022490|Primary|The Rate of Major Cytogenetic Response at 6 Months|Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.|6 months||||Participants|||Number
2852183|NCT00021255|Secondary|Overall Survival- Percentage of Participants Who Survived at 10 Years|Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.|From randomization until death or up to 10 years|ITT population.|||percentage of particpants||95% Confidence Interval|Number
2852184|NCT00021255|Secondary|Percentage of Participants With Disease Free Survival at 10 Years|Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 10 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
2852185|NCT00021255|Primary|Percentage of Participants With Disease Free Survival at 5 Years|Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
2852186|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.|||pg/ml||Standard Error|Mean
2852187|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.|||pg/ml||Standard Deviation|Mean
2852188|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.|||pg/ml||Standard Deviation|Mean
2852189|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.|||pg/ml||Standard Deviation|Mean
2852190|NCT00021229|Secondary|Median Overall Survival|Overall Survival (OS) is defined as the interval from initiation of treatment to death or date of last contact for surviving patients.|Assessed before radiation therapy, before the first dose of imatinib, then every 8 weeks.|The analysis population consists of the stratum I participants who received imatinib mesylate at or above the maximum tolerated dose. The median survival reported is based on these 20 participants.|||Days||95% Confidence Interval|Median
2852191|NCT00021229|Secondary|Peak Concentration (Cmax)|Peak concentration (cmax) is a pharmacokinetic measure defined as the highest concentration of a drug measured after the drug is administered. The cmax of imatinib mesylate on day 1 of course 1 is reported. Two milliliter (0.5 ml for children under the age of 5) blood samples were collected immediately prior to imatinib mesylate administration on Day 1 of Course 1 and at the following timepoints following drug administration: 0.5, 1, 1.5, 2, 4, 10 and 12 hours after the morning dose.|Day 1 of Course 1|The analysis population consists of participants who enrolled at the maximum tolerated dose (MTD) of the phase I component and who submitted day 1 course 1 samples for the PK studies. An MTD was not estimated in stratum IIB. For this stratum, reported are values at the stratum IIA MTD to allow comparison.|||µg/ml||Full Range|Mean
2852202|NCT00019682|Primary|Best Response Rate (Partial Response [PR] + Complete Response [CR])|A complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.|Up to 12 years||||Participants|||Count of Participants
2852192|NCT00021229|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of radiation (RT) on changes in various neuroimaging variables in pediatric brainstem gliomas (stratum I). Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline (pre-radiation) and within two (+/- one) weeks after completion of RT.|Baseline and two weeks post completion of radiation|The analysis population consists of Stratum I patients enrolled who had both pre and post radiation (RT) volume FLAIR measures. Stratum II participants did not receive RT and thus were not included.|||cubic centimeters||Full Range|Mean
2852193|NCT00021229|Primary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks|Per protocol, 40 participants who received at least one dose of drug were needed for this objective. The analysis population consists of stratum I participants enrolled at the maximum tolerated dose (phase 1) and the participants enrolled to the phase II part. The study was terminated because of poor accrual and the objective was not met.||||||
2852194|NCT00021229|Primary|Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consisted of phase I stratum II participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the DLT analysis population of 20 in stratum IIA was 465 mg/m2/day. An MTD was not established in stratum IIB as no DLTs were observed at the higher dose levels of 620 and 800 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum II participants who developed dose-limiting toxicities (DLT) during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs.|||Participants|||Number
2852195|NCT00021229|Primary|Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I stratum I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the 23 participants who either had a DLT during course 1 or 2 or completed courses 1 and 2 without DLT is 265 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.|||Participants|||Number
2852196|NCT00020722|Secondary|Overall Survival||Length of time from day of transplant until death.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.||||||
2852197|NCT00020722|Primary|Disease-free Survival||Length of time from day of transplant until recurrence or relapse.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.||||||
2852198|NCT00019747|Primary|Time to Progression|Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|62 months|The analysis was not done because there were not enough subjects to do any of the statistical analyses.||||||
2852199|NCT00019682|Secondary|Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)|QOL was measured before and after 2 cycles of treatment using 4 measures: FACT-G is a 27 item measure of QOL. A total score is calculated by summing across responses on a 5 point scale and ranges from 0-135, with higher scores indicating better QOL. FACT-F is 13 item measure of fatigue. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 0-52, with higher scores indicating less fatigue. SF-36 is a 36 item measure of self-reported health status. SF-36 is comprised of 8 subscales: physical function, role physical, bodily pain vitality, role emotional function, mental health, social function and general health. Summated scores range from 0-100, with higher scores indicating a better health state. SDS is a 13 item measure of symptom distress. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 13 to 65, with higher scores indicating more symptom distress.|Baseline to up to 8 weeks||||units on a scale||Standard Error|Mean
2852200|NCT00019682|Secondary|Change in T-cell Precursors|To measure change in T-cell precursors, PBMC were tested for reactivity by measuring gamma-interferon release after overnight coculture with peptide pulsed T2 cells. PBMC obtained after 4 cycles of study treatment were compared to pre treatment PBMC. A positive assay was defined as greater than 100pg/ml gamma-interferon release and at least twice the release (including all control peptides) by post treatment PBMC compared to pre treatment PBMC.|Baseline to up to 12 years|All patients with paired cryopreserved peripheral blood lymphocytes obtained before any treatment and after completing 4 cycles of treatment.|||Participants with a positive assay|||Number
2852201|NCT00019682|Secondary|Progression Free Survival|Progression free survival was compared between groups by means of Kaplan-Meier curves using the log-rank test to evaluate the significance of the difference between the arms.|From the date of randomization until documentation of progression or last follow up, assessed up to 12 years||||months||95% Confidence Interval|Median
2852203|NCT00019604|Secondary|Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)|PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852204|NCT00019604|Secondary|Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms|Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., <median change, >median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852205|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers|Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852206|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies|Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852207|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)|Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852208|NCT00019604|Secondary|Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)|Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852209|NCT00019604|Secondary|Tumor Vascular Density|Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852210|NCT00019604|Secondary|Tumor Blood Flow|Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.||||||
2852211|NCT00019604|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years, 9 months|NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.|||Participants|||Number
2852212|NCT00019604|Primary|Response|Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.||The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.|||Participants|||Number
2852213|NCT00017563|Primary|Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.|Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.|Every 3 months after surgery for up to 5 years.||||participants|||Number
2852252|NCT00009945|Primary|Disease Free Survival.|Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years|8 years||||percentage of patients|||Number
2852215|NCT00016913|Secondary|Time to Prostate-specific Antigen Failure|PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.|PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).|All 27 evaluable patients were used in this analysis.|||months||95% Confidence Interval|Median
2852216|NCT00016913|Primary|Toxicity|Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy.|90 days and 1 year post treatment|Final analyses were performed on all 27 eligible patients.|||Events|||Number
2852217|NCT00016354|Secondary|Test for Antitumor Activity in Blood and Tissue||baseline|||||||
2852218|NCT00016354|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU||8 weeks|||||||
2852219|NCT00016354|Secondary|Number of Patients With Adverse Events||every 4 weeks|||||||
2852220|NCT00016354|Primary|Determine Maximum Tolerated Dose of BPU|Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays >2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting <5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.|4 weeks (1 course of treatment for each subject)|Participants that completed at least 1 cycle of BPU.|||milligrams (mg)|||Number
2852221|NCT00015847|Primary|Major Cytogenetic Response After 6 and 12 Months of Treatment.|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:~Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%).~*Major cytogenetic response includes complete and partial cytogenetic response."|6 and 12 months after treatment||||Participants|||Number
2852222|NCT00015847|Primary|Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)|1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death|12 Months||||Participants|||Number
2852223|NCT00015847|Primary|Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II|||||||
2852224|NCT00015847|Primary|Complete Hematologic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II|||||||
2852225|NCT00015847|Primary|Minor Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II|||||||
2852226|NCT00015847|Primary|Complete Cytogenetic Response at 6 and 12 Months (Phase II)|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:~Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%)."|At 6 and 12 months during phase II||||Participants|||Number
2852227|NCT00014495|Primary|Maximum Tolerated Dose|The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.|2 years||||mCi/kg|||Number
2852228|NCT00014222|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the time of death from any cause, with censoring at longest follow-up.|13 years|Intention to treat population.|||Participants|||Count of Participants
2852229|NCT00014222|Primary|Disease Free Survival|Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence.|13 years|Intent to treat population was used for this analysis,.|||Participants|||Count of Participants
2852230|NCT00012298|Secondary|Tumor Response Rate (Phase II)|Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.|Assessed up to 5 years|All eligible phase II patients. One of the 39 phase II patients was deemed ineligible|||percentage of patients with response||95% Confidence Interval|Number
2852231|NCT00012298|Secondary|Time to Disease Progression (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to the earliest date documentation of>disease progression, assessed up to 5 years|All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible.|||years||95% Confidence Interval|Median
2852232|NCT00012298|Secondary|Survival (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|Phase II portion of the study. One patient out of the 39 was deemed ineligible and was not included in survival analysis.|||years||95% Confidence Interval|Median
2852233|NCT00012298|Secondary|Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)|Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.|At week 12|Not collected. Study team decision not to analyze this endpoint.||||||
2852234|NCT00012298|Secondary|Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)|Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals.|At week 12|Not collected. Study team decision not to analyze this endpoint.||||||
2852346|NCT00004092|Primary|Five-Year Relapse-free Survival|RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five years||||percentage of participants||95% Confidence Interval|Number
2852235|NCT00012298|Secondary|Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)|Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response.|At week 12|Not collected. Study team decision not to analyze this endpoint.||||||
2852236|NCT00012298|Primary|Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)|Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.|At 3 years|Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint.|||proportion of participants||95% Confidence Interval|Number
2852237|NCT00012298|Primary|Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)|Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.|Assessed up to week 24|All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.|||participants|||Number
2852238|NCT00012298|Primary|Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)|"This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.~> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event.~> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here."|At 8 weeks|DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.|||Patients reporting Dose-Limiting Events|||Number
2852239|NCT00012012|Secondary|Distant Metastases||From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
2852240|NCT00012012|Secondary|Pelvic Tumor Control||From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|||||||
2852241|NCT00012012|Primary|Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.|From start of treatment to 90 days|All eligible patients|||participants|||Number
2852242|NCT00012012|Primary|Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.|From start of treatment to 90 days|All eligible patients|||percentage of participants||95% Confidence Interval|Number
2852243|NCT00011986|Secondary|Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0||Up to 9 years|Eligible and treated participants|||Participants|||Count of Participants
2852244|NCT00011986|Primary|Progression-free Survival|Median duration in months of progression free survival.|From the date of enrollment to first progression or death or last contact, if alive and progression free.||||months||95% Confidence Interval|Median
2852245|NCT00011986|Primary|Overall Survival|Proportion of participants whose overall survival exceeded 5 years.|Up to 9 years|All enrolled participants.|||Proportion of participants|||Number
2852246|NCT00010257|Secondary|Duration of Response|Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria|assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Number of participants achieving a complete or partial response by RECIST criteria|||Months||95% Confidence Interval|Median
2852247|NCT00010257|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 2 cycles (6 weeks)|Analysis population included all eligible participants who received at least 1 dose of the protocol treatment|||Participants|||Number
2852248|NCT00009945|Secondary|Incidence of Non-skeletal Metastasis|Time from randomization to incidence of non-skeletal metastasis to determine the percentage of patients free from non-skeletal metastasis at 8 years|8 years||||percentage of patients|||Number
2852249|NCT00009945|Secondary|Relapse Free Survival|Time from randomization to any local, regional, or distant recurrence of breast cancer to determine the percentage of patients relapse free at 8 years|8 years||||percentage of patients|||Number
2852250|NCT00009945|Secondary|Overall Survival|Time from randomization to any death to determine the percentage of patients alive at 8 years|8 years||||percentage of patients|||Number
2852251|NCT00009945|Secondary|Skeletal Metastasis Free Survival|Time from randomization to first diagnosis of skeletal metastasis to determine the percentage of patient free of skeletal metastasis at 8 years|8 years||||percentage of patients|||Number
2852253|NCT00008385|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.|Assessed annually for 5 years after randomization|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2852254|NCT00008385|Secondary|5-year Progression-free Survival Rate|"Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate.~Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.~Different histologic type~Location in different lobe~Location in contralateral lung~Occurrence > 5 years after initial diagnosis"|Assessed annually for 5 years after randomization|All randomized patients|||proportion of participants||95% Confidence Interval|Number
2852255|NCT00008385|Primary|Incidence Rate of Second Primary Lung Tumor|Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.|Assessed annually for 10 years after randomization|all randomized patients|||cases/100 person years|||Number
2852256|NCT00008138|Primary|Progression-Free Survival|Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.|Only eligible patients were included in the analysis.|||months||95% Confidence Interval|Median
2852257|NCT00008138|Primary|Overall Survival|Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.|assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5|Only eligible patients were included in the analysis.|||months||95% Confidence Interval|Median
2852258|NCT00006916|Primary|Overall Survival|This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.|||||||
2852259|NCT00006903|Secondary|Number of Participants With Grade 3 or Greater Toxicity by Common Toxicity Criteria Version 3.0 That Were at Least Possibly Related to Study Drug.|Adverse events at least possibly related to Fulvestrant using Common Terminology Criteria version 3.0 that were grade 3 or higher with the exception of the reported Grade 5. Grade 5 adverse events were reported regardless of attribution to study treatment.|During study treatment and up to 30 days after stopping study|Eligible and evaluable patients.|||Participants|||Count of Participants
2852260|NCT00006903|Primary|Clinical Response by RECIST Criteria of Estrogen Receptor Expression|Per response evaluation criteria in Solid Tumors Criteria (RECIST 1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions. Overall Response = CR+PR|Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment, assessed up to 100 months.|Total number eligible and treated participants within groups defined by estrogen receptor status|||Participants|||Count of Participants
2852261|NCT00006903|Primary|Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks|"Primary outcome measured according to RECIST v1.0 Best Response:~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.|Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor.|||participants|||Number
2852262|NCT00006721|Primary|Overall Survival at 5 Years|Measured from date of registration to date of death due to any cause|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
2852263|NCT00006721|Primary|Overall Survival at 2 Years|Measured from date of registration to date of death due to any cause|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
2852264|NCT00006721|Primary|Progression-free Survival at 5 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
2852292|NCT00006227|Primary|Probability of Complete Clinical Response|The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma|Up to 5 years|Eligible and evaluable|||Percentage of Participants||80% Confidence Interval|Number
2852265|NCT00006721|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal|Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included|||Participants|||Number
2852266|NCT00006721|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||participants|||Number
2852267|NCT00006721|Primary|Progression-free Survival at 2 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.|||percentage of participants|||Number
2852268|NCT00006478|Secondary|Changes in Quantitative Bcl-2|To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.|1 year post transplant evaluation and then annually until disease progression|The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.||||||
2852269|NCT00006478|Secondary|Toxicity|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion|The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.||||||
2852270|NCT00006478|Secondary|Safety|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion|The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.||||||
2852271|NCT00006478|Primary|Number of Participants With Humoral and Cellular Immune Response|evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation|immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression|NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.||||||
2852272|NCT00006392|Secondary|Number of Participants With Serious Cardiovascular Events|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
2852273|NCT00006392|Secondary|Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.|||participants|||Number
2852274|NCT00006392|Secondary|Number of Participants With Any Diagnosis of Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
2852293|NCT00006110|Secondary|Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.|Percent of patients receiving and not receiving Herceptin who are alive and disease-free at 5 years.|5 years||||percentage of patients|||Number
2852367|NCT00003875|Secondary|Proportion of Patients Who Relapsed Associated With the Regimen||From date of transplant to date of death from any cause, assessed up to 178 months||||Participants|||Count of Participants
2852275|NCT00006392|Secondary|Number of Participants With Colorectal Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
2852276|NCT00006392|Secondary|Number of Participants With Lung Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.|||participants|||Number
2852277|NCT00006392|Primary|Number of Participants With Prostate Cancer|Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.|Every six months for 7 to 12 years depending on when the participant was randomized.|All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.|||participants|||Number
2852278|NCT00006389|Secondary|Progression-free Survival|Progression-free survival was estimated according to the Kaplan-Meier product-limit method|18 months||||months||95% Confidence Interval|Median
2852279|NCT00006389|Secondary|Overall Survival|Overall survival was estimated according to the Kaplan-Meier product-limit method.|18 months||||Months||95% Confidence Interval|Median
2852280|NCT00006389|Primary|Observed Response Rate.|"All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 target lesions were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference~The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval."|Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.|The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.|||Percentage of Participants||95% Confidence Interval|Number
2852281|NCT00006244|Secondary|Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity|Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by older (≥56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.|First 100 days post-transplant|Of the 36 patients, 16 patients were ≥56 years old and these 16 are used to determine this outcome measure.|||Participants|||Count of Participants
2852282|NCT00006244|Secondary|Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity|Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.|First 100 days post-transplant|Of the 36 patients, 20 patients were <56 years old and these 20 patients are used to determine this outcome measure.|||Participants|||Count of Participants
2852283|NCT00006244|Primary|Proportion of Patients Alive and in Remission||12.9 Median Years||||Participants|||Count of Participants
2852284|NCT00006244|Primary|Time to Disease Progression||12.9 years (median)|Out of 36 patients, 30 have relapsed and they are used to determine this outcome measure.|||years||Full Range|Median
2852285|NCT00006244|Primary|Initial Response to Therapy|Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)|Evaluated at Day +84-90 Post-Transplant||||Participants|||Count of Participants
2852286|NCT00006244|Primary|Overall Survival|Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.|12.9 Median Years||||Participants|||Count of Participants
2852287|NCT00006237|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.|Eligible patients who started therapy|||Participants|||Number
2852288|NCT00006237|Primary|5-year Relapse-Free Survival|Measured from date of registration to date of first observation of progressive disease or death due to any cause.|Every three months for the first year, every 6 months for years 2-5, annually for years 6-10||||Percentage of population|||Number
2852289|NCT00006237|Primary|5-year Overall Survival|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for a year, every six months for years 2-5, annual for years 5-10||||Percent of population|||Number
2852290|NCT00006227|Secondary|Overall Survival|Duration of overall survival (median) (months)|The observed length of life from entry into the study to death or the date of last contact||||Months||80% Confidence Interval|Median
2852291|NCT00006227|Secondary|Progression-free Survival|Duration of progression free survival (median) (months)|The period from study entry until disease progression, death or date of last contact||||Months||80% Confidence Interval|Median
2852294|NCT00006110|Secondary|Overall Response|Measured by the Overall Response. Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|78 weeks (1.5 years)|Protocol specifies that Response will be examined in patients who were treated neoadjuvantly. Because of this, only patients treated with Herceptin neoadjuvantly and non-Herceptin patients were included in this analysis. One patient was found unevaluable in the AC-P group and was not included in the analysis.|||Participants|||Count of Participants
2852295|NCT00006110|Primary|Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.|Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.|78 weeks (1.5 years)|LVEF data during AC-TP are complete on 50 patients. 2 are incomplete because of withdrawal (1) and progressive disease (1). 43 of the 52 patients underwent LVEF determination at 1.5 years.|||Participants|||Count of Participants
2852296|NCT00006101|Primary|Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months|Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.|Baseline and 12 months|The results reported include all men with both an entrance and exit biopsy, regardless of cancer status.|||Relative % difference||Standard Deviation|Mean
2852297|NCT00006011|Primary|Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.|"Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.~Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.~Intention to treat among eligible participants who receive random treatment allocation."|study entry up to 5 years post treatment||||participants|||Number
2852298|NCT00005957|Secondary|Disease-free Survival|Disease-free survival (including locoregional and distant disease)|10 years|Intention-to-treat|||percentage of disease-free at 10 years||95% Confidence Interval|Number
2852299|NCT00005957|Primary|Overall Survival|Duration of study|10 years|Intention-to-treat|||percentage of alive at 10 years||95% Confidence Interval|Number
2852300|NCT00005879|Primary|Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months|"Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.~Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia."|Baseline to 6 months|Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in cytomorphology category.|||Participants|||Count of Participants
2852301|NCT00005879|Primary|Change in Masood Score|"Change in the semi-quantitative score assigned by the designated cytopathologist.~Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4."|Baseline to 6 months|Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in Masood score.|||units on a scale||Standard Deviation|Mean
2852302|NCT00005803|Secondary|Progression Free-survival (PFS)|Number of patients surviving without disease by interval. Chemosensitive and chemoresistant subjects will be analyzed separately.|From the date of autologous transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, assessed up to 3 years|One patient who counted to accrual is not included here. They received conditioning for autologous transplant, but then did not receive the transplant.|||Participants|||Count of Participants
2852303|NCT00005803|Secondary|Overall Survival (OS)|Number of patients surviving by interval. Chemosensitive and chemoresistant subjects will be analyzed separately.|From the date of autologous transplant until the time of death, assessed up to 3 years|One patient who counted to accrual is not included here. They received conditioning for autologous transplant, but then did not receive the transplant.|||Participants|||Count of Participants
2852304|NCT00005803|Primary|Non-Relapse Mortality|"The rates and accompanying confidence intervals associated with transplant-related mortality will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)."|Day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting|Although 54 patients received both auto transplant & allo transplant, one patient did not survive to day 100.|||Participants|||Count of Participants
2852305|NCT00005803|Primary|Engraftment of HLA Identical PBSC Allografts|"Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)."|Day 56|Only includes patients who received allo transplant. One patient is excluded because they did not survive long enough to test for engraftment.|||Participants|||Count of Participants
2852306|NCT00005047|Secondary|Probability of Overall Survival|Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of survival were based on the Kaplan-Meier product-limit method.|5 years|This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).|||probability||Standard Error|Median
2852317|NCT00004888|Secondary|Duration of Response|Defined as time from onset of PR or CR, whichever occurred first, until objective evidence of progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|Responders|||Months||95% Confidence Interval|Median
2852307|NCT00005047|Secondary|Probability of Recurrence|"Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations.~Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care."|5 years|This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).|||probability||Standard Error|Median
2852308|NCT00005047|Secondary|Probability of Overall Survival|p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Survival is calculated from registration to death due to any cause. Probabilities of survival were based on the Kaplan-Meier product-limit method.|5 years||||probability||Standard Error|Median
2852309|NCT00005047|Primary|Probability of Recurring|"p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves.~Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care."|5 years||||probability||Standard Error|Median
2852310|NCT00005044|Secondary|Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)|Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with adverse event data in corresponding time frame (during hormone therapy and <=90 days from RT start; > 90 days from RT start)|||percentage of participants|||Number
2852311|NCT00005044|Secondary|Time to Second Biochemical Failure (SBF) (10-year Rates Reported)|Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2852312|NCT00005044|Secondary|Time to First Biochemical Failure (BF) (10-year Rates Reported)|"Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored.~Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported."|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2852313|NCT00005044|Secondary|Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)|Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2852314|NCT00005044|Secondary|Disease-free Survival (DFS) (10-year Rates Reported)|Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients without follow-up data|||percentage of participants||95% Confidence Interval|Number
2852315|NCT00005044|Secondary|Overall Survival (OS) (10-year Rates Reported)|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2852316|NCT00005044|Primary|Disease-specific Survival (DSS) (10-year Rates Reported)|Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.|From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)|Eligible patients with follow-up data|||percentage of participants||95% Confidence Interval|Number
2852343|NCT00004124|Primary|Disease Free Survival|Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.|at 10 Years|Intent-to-treat|||percentage of probability of survival|||Number
2852318|NCT00004888|Primary|Summary of Left Ventricular Ejection Fraction Values|This table summarizes the LVEF information at baseline, post Cycle 4, post Cycle 8, and 30 or more days after Cycle 8 on all treated patients and on the eligible subset. LVEF drops reported are absolute (not relative) drops.|Baseline, after cycle 4, after cycle 8, and 30 or more days after last cycle of induction therapy.|All treated patients|||LVEF percent||Standard Deviation|Mean
2852319|NCT00004888|Secondary|Progression-Free Survival|Progression-Free Survival was defined as time from study entry to progression or to death without documentation of progression. A progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis. Please note that 2 patients on Arm B died without documentation of progression. Also, 4 patients died or were taken off treatment before follow-up evaluations, and PFS was censored at zero.|||months||95% Confidence Interval|Median
2852320|NCT00004888|Secondary|Overall Survival||Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis.|||months||95% Confidence Interval|Median
2852321|NCT00004888|Secondary|Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.|Please note that overall response includes CR and PR. CR is defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. PR is greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. No change is defined as no significant change in measurable or evaluable disease for at least 4 weeks. Progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of Nov 21, 2007 is used for this report. Please note that best overall response is reported in the table.|Eligible Patients|||participants|||Number
2852322|NCT00004888|Primary|Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event|This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.|Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy|Treated patients who had a cardiotoxicity event|||participants|||Number
2852323|NCT00004859|Primary|Overall Survival Time|Survival time is defined as time from study entry to death from any cause|every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5|intent to treat analysis in the 546 eligible patients|||Months||95% Confidence Interval|Median
2852324|NCT00004859|Secondary|Response Rate at Best Response to Treatment|Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year||||Proportion of participants||95% Confidence Interval|Number
2852325|NCT00004859|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year||||Months||95% Confidence Interval|Median
2852326|NCT00004259|Secondary|(Phase III) Progression-free Survival by MGMT Status|Progression is defined as a radiographic increase in size of the lesion by > 25%, recurrence of the study lesion, or the development of new lesions, confirmed by imaging. Progression-free survival time is defined as time from randomization to date of progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue samples were analyzed for methylation status of methyl guanine methyl transferase (MGMT), classified as methylated vs. unmethylated.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible patients with MGMT data|||years||95% Confidence Interval|Median
2852327|NCT00004259|Secondary|(Phase III) Survival Time by MGMT Status|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue samples were analyzed for methylation status of methyl guanine methyl transferase (MGMT), classified as methylated vs. unmethylated.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible patients with MGMT data|||years||95% Confidence Interval|Median
2852328|NCT00004259|Secondary|(Phase III) Number of Patients With Grade 3 or Higher Toxicity|Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the AE. The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The number of patients with grade or higher toxicity was calculated overall and for non-hematologic toxicity only. Per the protocol, the pilot arms were not included in the Phase III analyses.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible randomized patients who started study treatment|||participants|||Number
2852329|NCT00004259|Secondary|(Phase III) Time to Tumor Progression (TTP)|Three-year rate is reported. Progression is defined as a radiographic increase in size of the lesion by > 25%, recurrence of the study lesion, or the development of new lesions, confirmed by imaging. Time to tumor progression was estimated using the cumulative incidence function (CIF) on tumor progression, with death as a competing risk. Per the protocol, the pilot arms were not included in the Phase III analyses.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible randomized patients|||months||95% Confidence Interval|Median
2852330|NCT00004259|Primary|(Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms|Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the adverse event (AE). The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Dose limiting toxicity (DLT) was defined as grade 3+ pulmonary toxicity, grade 4+ thrombocytopenia (< 25,000 for 5 days), neutropenia (< 500/microl for 7 days), or neutropenia of any duration with fever requiring hospital admission after one dose reduction of 50% in BCNU. A 20% rate of grade 3+ pulmonary toxicities or a 40% rate of grade 4+ thrombocytopenia and neutropenia was considered unacceptable for a treatment arm combining RT, TMZ, and BCNU.|From start of treatment to 3 months|Eligible patients who started study treatment on Pilot Arms 1 and 2|||Participants|||Count of Participants
2852331|NCT00004259|Primary|(Phase III) Overall Survival (OS)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Per the protocol, the pilot arms were not included in the Phase III analyses.|From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.|Eligible randomized patients|||years||95% Confidence Interval|Median
2852332|NCT00004228|Secondary|Percentage of Patients With Overall Survival as Assessed by Time to Death|Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.|||percentage of participants||95% Confidence Interval|Number
2852333|NCT00004228|Primary|Event-free Survival|Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.|||percentage of particpants||95% Confidence Interval|Number
2852334|NCT00004143|Primary|Number of Participants With Transplant-related Mortality|Number of patients who died due to transplant-related complications|100 days||||participants|||Number
2852335|NCT00004143|Primary|Number of Participants With Grade 3-4 Unexpected Adverse Events|An unexpected adverse event is one that differs in the nature, severity, or frequency from (a) the research procedures that are described in the protocol-related documents, (such as the IRB-approved research protocol and informed consent document) as expected, and/or (b) the characteristics of the subject population being studied.|45 days post transplant||||participants|||Number
2852336|NCT00004143|Primary|Number of Patients With Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Number of patients with Grade 3-4 acute Graft Versus Host Disease (GVHD). GVHD will be monitored at least two times per week through day 45, then weekly through day 60 and graded by 2 persons at each institution, to ensure internal consistency in grading.|60 days post transplant||||participants|||Number
2852337|NCT00004143|Secondary|Overall Survival|Number of patients alive 2 years after transplant|2 years||||participants|||Number
2852338|NCT00004143|Primary|Number of Patients With Platelet Engraftment|Number of patients with platelet engraftment - Platelets > 20,000/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant||||participants|||Number
2852339|NCT00004143|Primary|Number of Patients With Neutrophil Engraftment|Number of patients with neutrophil engraftment: Absolute Neutrophil Count (ANC) > 500/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant||||participants|||Number
2852340|NCT00004124|Secondary|PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival||Up to 10 Years|Data not collected for analysis.||||||
2852341|NCT00004124|Secondary|PSA Progression Free Survival|Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of > 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.|Up to 10 Years|Data for trial not collected for analysis.||||||
2852342|NCT00004124|Secondary|Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients|Number of patients with adverse events that are related to study drug|Up to 22 months from registration|All eligible patients who received protocol therapy|||Participants|||Number
2852344|NCT00004124|Primary|Overall Survival|Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.|at 10 Years||||percentage of probability of survival|||Number
2852347|NCT00004088|Primary|Best Response After Tandem Autologous Stem Cell Transplant and Maintenance|"Response gradations are specified in the Blade criteria, Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs."|Response after six months after day 0 of the first cycle of the tandem transplant, after administration of maintenance thalidomide if necessary, until three years post-day 0 of the first cycle of the tandem transplant.||||Participants|||Count of Participants
2852348|NCT00004088|Primary|Best Response at 6 Months Post Tandem Autologous Stem Cell Transplant|"Response gradations are specified in the Blade criteria, Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs."|Six months after day 0 of the first cycle of the tandem autologous stem cell transplant. This will be used to determine administration of thalidomide.||||Participants|||Count of Participants
2852349|NCT00004088|Primary|Progression-free Survival|"Kaplan-Meier estimate at three years post-first transplant of survival. Event of interest is the first of Death or Progression. Censoring is Alive in Continuous Complete Remission at date of last follow-up.~95 percent confidence interval of the point estimate is calculated using Greenwood's variance."|Estimate reported at three years after day 0 of the first cycle of infusion of cells of the tandem transplant.||||proportion of participants||95% Confidence Interval|Number
2852350|NCT00004088|Primary|Three-year Overall Survival|Kaplan-Meier estimate at three years post-first transplant of survival. Outcome is death or alive at follow-up (censored). 95 percent confidence interval of the point estimate is calculated using Greenwood's variance.|Estimate reported at three years after day 0 of the first cycle of infusion of cells of the tandem transplant.||||proportion of participants||95% Confidence Interval|Number
2852351|NCT00004088|Primary|Response After Tandem Autologous Stem Cell Transplant|"Response gradations are specified in the Blade criteria, Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs."|After second cycle of tandem autologous stem cell transplant: Day 0 of second transplant to 12 weeks post-cycle 2 cell infusion of the tandem transplant.||||Participants|||Count of Participants
2852352|NCT00004088|Primary|Best Response Prior to Tandem Autologous Stem Cell Transplant|"Response gradations are specified in the Blade criteria, Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs."|From enrollment in the study until day -8: before dilantin given pre-first high-dose chemo preceeding first cycle of tandem autologous cell transplant||||Participants|||Count of Participants
2852353|NCT00004054|Secondary|Disease-free Survival Rate at 5 Years|Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
2852354|NCT00004054|Secondary|Rate of Distant Metastasis at Five Years|Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
2852429|NCT00003460|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852355|NCT00004054|Secondary|Rate of Local Progression at 5 Years|Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
2852356|NCT00004054|Secondary|Rate of Biochemical Failure at 5 Years|Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method.|From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.|All randomized patients|||percentage of participants||95% Confidence Interval|Number
2852357|NCT00004054|Primary|Overall Survival (5-year Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.|From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.|All randomized patients.|||percentage of participants||95% Confidence Interval|Number
2852358|NCT00003910|Secondary|Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX|We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement.|Assessed during the first 4 months of treatment and followed until reaching full study stop date|Eligible patients who received Cy after failing to respond to MTX are included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2852359|NCT00003910|Primary|Proportion of Patients With Complete or Partial Response to Treatment With MTX|We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement.|Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.|Of the 59 pts, 4 were ineligible and excluded from the analysis.|||proportion of participants||95% Confidence Interval|Number
2852360|NCT00003901|Secondary|Disease-Free Survival in Bone Marrow Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM|||years||95% Confidence Interval|Median
2852361|NCT00003901|Secondary|Disease-Free Survival in Lymph Nodes Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM|||years||95% Confidence Interval|Median
2852362|NCT00003901|Primary|Overall Survival in Bone Marrow Examined Patients|Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM|||years||95% Confidence Interval|Median
2852363|NCT00003901|Primary|Overall Survival in Lymph Nodes Examined Patients|Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM|||years||95% Confidence Interval|Median
2852364|NCT00003896|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly during 6 weeks of protocol treatment|Paclitaxel/CDDP/Liposomal doxorubicin|||Participants|||Number
2852365|NCT00003896|Primary|Overall Survival|from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact|Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.|All eligible patients who began the treatment intervention.|||months||95% Confidence Interval|Median
2852366|NCT00003896|Primary|Progression-free Survival|From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.|Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.|Eligible patients who began the treatment intervention|||months||95% Confidence Interval|Median
2852368|NCT00003875|Primary|Toxicity Associated With Aldesleukin Treatment After Stem Cell Rescue|Toxicity during IL-2 therapy of any of the following per NCI Common Toxicity version 3: grade 2, 3, 4, or 5 CNS (except grade 0-3 malaise, fatigue, anxiety and depression) toxicity; grade 3, 4, or 5 non-CNS or non-hematologic toxicity; any grade 4 or 5 hematologic toxicity.|IL-2 administration to one month after completion of IL-2 treatment|29 patients underwent autologous transplant and 21 of these patients after transplant went on to get IL-2 treatment . Toxicity for IL-2 therapy thus was only analyzed in these later 21 patients.|||Participants|||Count of Participants
2852369|NCT00003875|Primary|Toxicity Associated With High-dose Busulfan and Etoposide Followed by Stem Cell Rescue|Toxicity is defined as any grade 3 or grade 4 toxicity per the Bearman toxicity grading criteria following Busulfan and Etoposide high-dose chemotherapy, stem cell transplant, and the inability to recover sufficiently by day 100 to start IL-2 therapy.|Day -7 of transplant to 100 days post transplant||||Participants|||Count of Participants
2852370|NCT00003875|Primary|Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin|Estimated by the method of Kaplan and Meier.|From date of transplant to date of death from any cause, assessed up to 178 months||||Participants|||Count of Participants
2852371|NCT00003869|Secondary|Number of Patients With a Confirmed Tumor Responses Treated With CAI.|"Confirmed response was defined as a complete response (CR) or partial response (PR) for patients with measurable disease or as a CR or regression (REGR) for patients with evaluable disease noted on 2 consecutive evaluations at least 4 weeks apart.~CR: total disappearance of all tumor;~PR: >=50% reduction of the sum of the products of the two greatest perpendicular diameters of all indicator lesions;~REGR: Definite decrease in tumor size and no new lesion(s)."|During Treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently due to the trial design. (Patients were required to be SD or better to be randomized to carboxyamidotriazole or placebo.)||||||
2852372|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8|The FACT-L is a 36-item Likert instrument that combines frequency of symptomatic/QOL problems with perceived relative importance of each issue. It includes 4 constructs of well being: physical, social/family, emotional and functional, and a fifth construct, additional concerns, dealing solely with tumor related symptoms. Questionnaires were completed at baseline and 8 weeks. Questions within each construct were summated to obtain a construct score. A higher score relates to higher quality of life. A 10 point or greater decline (from baseline to week 8) was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 FACT-L assessment are included in the analysis.|||participants|||Number
2852373|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8|The UNISCALE was used to assess QOL. UNISCALE is a single item global measure of QOL. Participant were to complete the questionnaire at baseline and every 8 weeks, prior to assessment by the treating physician. A high score indicates a higher quality of life while a low score represents a lower quality of life. A 10 point or greater decline (from baseline to week 8) in UNISCALE QOL score was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 UNISCALE assessment are included in the analysis.|||participants|||Number
2852374|NCT00003869|Secondary|Time to Disease Progression (TTP)|"TTP is defined as the time from randomization to first documented disease progression(PD). Patients who were lost to follow-up were censored at the time of last evaluation. For patients who died without clear documentation, PD was assumed at the midpoint of the time interval between last evaluation and death. Median TTP was estimated using the Kaplan Meier method.~Measurable PD: ≥25% increase in the sum of the products of two greatest perpendicular diameters of all indicator lesions or appearance of new lesion(s). Evaluable PD: definite increase in tumor size or appearance of new lesion(s)"|up to 5 years|TTP was analyzed on all randomized patients on an intent to treat basis.|||Months||95% Confidence Interval|Median
2852375|NCT00003869|Secondary|Participants With Severe Non-hematologic Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC version 2.0)|every cycle during treatment|All treated participants; all participants who received study treatment.|||Participants|||Number
2852376|NCT00003869|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Overall survival was analyzed on all randomized participants on an intent to treat basis.|||Months||95% Confidence Interval|Median
2852377|NCT00003820|Secondary|Overall Response Rate (ORR)|"Overall response as assessed as Complete Response (CR) + Partial Response (PR)~CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue.~PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR."|4 weeks|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.|||percentage of participants|||Number
2852378|NCT00003820|Secondary|Overall Survival (OS)|OS, assessed as the number of patients 5 years after treatment who are alive|5 years|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.|||participants|||Number
2852430|NCT00003460|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852379|NCT00003820|Primary|Progression-free Survival (PFS)|PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion|5 years|This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.|||participants|||Number
2852380|NCT00003782|Secondary|Amenorrhea in Premenopausal Women||baseline, 9 weeks, and 6, 12, 18, and 24 months|||||||
2852381|NCT00003782|Secondary|Quality of Life Among Breast Cancer Patients||baseline, 9 weeks, and 6, 12, 18, and 24 months|||||||
2852382|NCT00003782|Secondary|Toxicities Among the 3 Regimens||9 years|||||||
2852383|NCT00003782|Primary|Disease Free Survival||time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event|||||||
2852384|NCT00003782|Primary|Overall Survival||8 years||||percentage of patients alive|||Number
2852385|NCT00003702|Secondary|Number of Patients With a Decline of hCG on Day 1 of Treatment|Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.|Prior to study entry and on Day 1 of treatment|Eligible and evaluated patients|||Participants|||Count of Participants
2852386|NCT00003702|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.|Eligible and treated patients|||Participants|||Count of Participants
2852387|NCT00003702|Primary|Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay|Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.|Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.|Eligible patients who received a random treatment allocation|||Participants|||Count of Participants
2852388|NCT00003659|Secondary|Overall Survival Status|The 5 year survival rate. The survival of patients with this disease is dependent on the stage of disease. Two useful staging systems are: Three-stage Rai System Clinical Feature and the Binet System.|up to 5 years|All assessable patients as indicated in the protocol.|||participants|||Number
2852389|NCT00003659|Secondary|Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease|The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol. Immunophenotypic analysis of bone marrow and/ or peripheral blood demonstrate a normal k:λ ratio and a normal number of CD5/CD19 (or CD5/CD20) dual staining cells (<5% of the lymphocyte gate).|3 years|All assessable patients as indicated in the protocol|||participants|||Number
2852390|NCT00003659|Primary|Overall Response Rate|Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response.|3 years|There were 36 assessable patients as described in the protocol|||participants|||Number
2852391|NCT00003644|Primary|Number of Participants With Adverse Events Grade 3 or Greater|Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants|Throughout study treatment lasting up to 24 weeks|All treated participants|||Participants|||Count of Participants
2852392|NCT00003644|Primary|Overall Survival|Number of deaths during study and follow up.|up to 96 months|All eligible and treated participants|||Participants|||Count of Participants
2852393|NCT00003644|Primary|Progression-free Survival|The percent of participants with disease recurrence within 5 years|Up to 5 years|Eligible and treated participants|||percentage of participants||95% Confidence Interval|Number
2852394|NCT00003641|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients|||proportion of participants||95% Confidence Interval|Number
2852395|NCT00003641|Primary|5-year Relapse-free Survival Rate|Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients|||proportion of participants||95% Confidence Interval|Number
2852396|NCT00003631|Primary|Objective Response|Determine the overall objective response. CR rate [as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated|2 years||||participants|||Number
2852397|NCT00003590|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months|Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants with a given type of AE|||Number
2852431|NCT00003459|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852398|NCT00003590|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).|Patients treated for 2 years or progression. If responding can continue at physician's discretion.|All eligible patients who started treatment were included in assessing response estimates.|||Participants|||Number
2852399|NCT00003537|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852400|NCT00003537|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
2852401|NCT00003535|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
2852402|NCT00003535|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
2852403|NCT00003499|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
2852404|NCT00003499|Primary|Number of Participants With Objective Response|Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852405|NCT00003483|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
2852406|NCT00003483|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
2852407|NCT00003479|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of Participants|||Number
2852408|NCT00003479|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
2852409|NCT00003477|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852410|NCT00003477|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
2852411|NCT00003476|Secondary|Percentage of Participants Who Survived|Six months and Twelve months overall survival|6 months, 12 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852448|NCT00003377|Primary|Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment||up to 21 weeks||||participants|||Number
2852412|NCT00003476|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
2852413|NCT00003475|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852414|NCT00003475|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852415|NCT00003474|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852416|NCT00003474|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
2852417|NCT00003473|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852418|NCT00003473|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852419|NCT00003472|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852420|NCT00003472|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
2852421|NCT00003471|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months||||Percentage of participants|||Number
2852422|NCT00003471|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
2852423|NCT00003470|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852424|NCT00003470|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months||||Participants|||Number
2852425|NCT00003469|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852426|NCT00003469|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852427|NCT00003468|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852428|NCT00003468|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks..|12 months||||Participants|||Number
2852432|NCT00003459|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852433|NCT00003458|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852434|NCT00003458|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Number
2852435|NCT00003457|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852436|NCT00003457|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), < 50% decrease and < 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.|12 months||||Participants|||Number
2852437|NCT00003456|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy|||Percentage of participants|||Number
2852438|NCT00003456|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
2852439|NCT00003453|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months||||Percentage of participants|||Number
2852440|NCT00003453|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months||||Participants|||Count of Participants
2852441|NCT00003404|Secondary|Survival Rate|Survival will be tracked for 10 years after initial resection of first participant treated.|Approximately 5 years|All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years.|||Participants|||Count of Participants
2852442|NCT00003404|Primary|Local Recurrence Rate|Local recurrence rate of phyllodes tumors|36 months after initial excision||||Participants|||Count of Participants
2852443|NCT00003389|Secondary|Incidence of Second Cancers|Number of patients who developed second primary cancers|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years||||participants|||Number
2852444|NCT00003389|Secondary|5-year Overall Survival|Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years.|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years|Eligible patients|||Proportion of patients||95% Confidence Interval|Number
2852445|NCT00003389|Primary|Failure-free Survival at 5 Years|"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission."|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5|Eligible patients|||Proportion of patients||95% Confidence Interval|Number
2852446|NCT00003377|Secondary|Overall Survival at 2 Years|Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97)|2 years||||probability||95% Confidence Interval|Mean
2852447|NCT00003377|Secondary|Disease-free Survival at 2 Years|"Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86).~Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study."|2 years||||probability||95% Confidence Interval|Mean
2852449|NCT00003199|Secondary|Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF|IL-2/GM-CSF toxicity assessed using the NCI Toxicity Criteria. Toxicity was defined as any grade 2, 3, 4 or 5 CNS (except grade 0-3 malaise and fatigue) toxicity; any grade 3, 4, or 5 non-CNS or non-hematological toxicity (except grade 0-3 bilirubin); or any grade 4 or 5 hematological toxicity.|16 Weeks|28 (56%) of 50 patients started IL-2/GM-CSF immunotherapy. Stopping rules were not met for this study.|||Participants|||Count of Participants
2852450|NCT00003199|Secondary|Overall Survival|Overall survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.|11 years||||Participants|||Count of Participants
2852451|NCT00003199|Primary|Event-free Survival|Event-free survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.|11 years|Study-wide, 20 patients out of 50 have event-free survival.|||Participants|||Count of Participants
2852452|NCT00003138|Secondary|Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months|The FACT-G scale has 4 dimensions, including physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each subscale was added together to obtain the total FACT-G score that was evaluated on this study. The total FACT-G score ranges from 0 to 108 with higher scores reflecting better quality of life. It was administered at the time of study entry, every 4 months for the first year, and at the time patient went off treatment. Due to limited data after 4 months on treatment, the analysis was restricted to the four-month time point.|Assessed at 4 months|Only patients who completed quality of life assessment at 4 months were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
2852453|NCT00003138|Secondary|Overall Survival|Time from randomization to death from any cause. Patients alive at the time of analysis were censored at the date of last contact.|Assessed every 3 months for 2 years, every 6 months for 3 subsequent years, and annually thereafter|All patients with complete data were included in this analysis.|||Months||95% Confidence Interval|Median
2852454|NCT00003138|Primary|Proportion of Patients Free of Transfusion at 4 Months|Whether a patient required transfusion or not at 4 months was recorded.|Assessed at 4 months|Only patients with transfusion data were included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
2852455|NCT00002975|Primary|Response Rate||One Year|PI died, leaving incomplete data. Data not analyzed.||||||
2852456|NCT00002931|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.||||Months||95% Confidence Interval|Median
2852457|NCT00002931|Primary|Toxic Effects|Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy|From date of randomization until death of any cause, assessed up to 12 weeks||||participants|||Number
2852458|NCT00002931|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.|Until disease progression, up to 5 years.||||Months||95% Confidence Interval|Mean
2852459|NCT00002874|Secondary|Grade 3+ Toxicity|"Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as Acute Radiotherapy, all later toxicities are reported as Hormone therapy and late radiotherapy toxicity. The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death."|From date of randomization to four years.|Eligible patients who started protocol treatment and did not withdraw consent.|||participants|||Number
2852460|NCT00002874|Secondary|Progression-free Survival (12-year Rates Reported)|"Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. Progression-free Survival is more accurate wording for the protocol endpoint of Freedom from Progression, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2852461|NCT00002874|Secondary|Prostate Cancer Death (12-year Rates Reported)|"Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. Prostate cancer death is a more accurate wording for the protocol endpoint of disease-specific survival, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2852462|NCT00002874|Secondary|Distant Failure (12-year Rates Reported)|Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2852463|NCT00002874|Secondary|PSA Complete Response at End of Protocol Treatment|Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA < 05 ng/ml.|End of protocol treatment, which is planned to last for two years|Eligible patients who did not withdraw consent.|||Participants|||Count of Participants
2852464|NCT00002874|Secondary|Third PSA Recurrence (12-year Rates Reported)|Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From start of salvage hormone therapy to 12 years.|Eligible patients who did not withdraw consent and who started salvage hormone therapy.|||percentage of participants||95% Confidence Interval|Number
2852465|NCT00002874|Secondary|Second PSA Recurrence (12-year Rates Reported)|Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to >= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of >= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of >= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2852466|NCT00002874|Secondary|Non-Prostate Cancer Death (12-year Rates Reported)|"Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported.~Patients are followed until death. Non-Prostate cancer death is a more accurate wording for the protocol endpoint of non-disease-specific survival, and matches the protocol definition."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2852467|NCT00002874|Primary|Overall Survival (12-year Rates Reported)|"Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported.~Patients are followed until death."|From date of randomization to 12 years.|Eligible patients who did not withdraw consent.|||percentage of participants||95% Confidence Interval|Number
2852468|NCT00002850|Primary|Proportion of Patients Experiencing a Serious Bacterial Infection|This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.|First three months of chemotherapy||||percentage of participants||95% Confidence Interval|Number
2852469|NCT00002842|Primary|2 Year Disease-free Survival .|Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.|2 years after treatment||||percentage of participants||95% Confidence Interval|Number
2852470|NCT00002766|Primary|Complete Remission (CR)|complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.|2 years||||participants|||Number
2852471|NCT00002651|Other Pre-specified|General Symptoms||15 months|||||||
2852472|NCT00002651|Other Pre-specified|Role Functioning|Mean of the change in role functioning from randomization|15 months|||||||
2852473|NCT00002651|Other Pre-specified|Social Functioning|Mean of the change in social functioning from randomization|15 months|||||||
2852474|NCT00002651|Other Pre-specified|Global Perception of Quality of Life||15 months|||||||
2852475|NCT00002651|Primary|Vitality|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months.|3 months|Only eligible patients with a usable form set for Vitality both at baseline and 3 months were included in this analysis.|||units on a scale||Standard Error|Mean
2852476|NCT00002651|Primary|High Libido|"This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. High Libido is defined as very high, high or moderate interest in sexual activities."|3 months|Only eligible patients with a usable answers regarding libido both at baseline and 3 months were included in this analysis.|||percentage of participants|||Number
2852509|NCT00051363|Other Pre-specified|Functional Magnetic Resonance Imaging (fMRI)||Measured at diagnostic visit (baseline) and 6 months post intervention|fMRI was dropped as a secondary outcome measure for analysis by our Core Team.||||||
2852477|NCT00002651|Primary|Erectile Dysfunction|This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months.|3 months|Only eligible patients with a usable answers regarding erectile dysfunction both at baseline and 3 months were included in this analysis.|||percentage of participants|||Number
2852478|NCT00002651|Primary|Emotional Functioning as Measured by the SF-36 Mental Health Inventory|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months|3 months|Only eligible patients with a usable form set for SF-36 Mental Health Inventory both at baseline and 3 months were included in this analysis.|||units on a scale||Standard Error|Mean
2852479|NCT00002651|Primary|Physical Functioning as Measured by the SF-36|This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months|3 months|Only eligible patients with a usable form set for Physical Functioning portion of the SF-36 both at baseline and 3 months were included in this analysis.|||units on a scale||Standard Error|Mean
2852480|NCT00002651|Primary|Overall Survival|Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9).|Up to 15 years||||years||95% Confidence Interval|Median
2852481|NCT00002558|Primary|Overall Objective Response|Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}|2 years||||participants|||Number
2852482|NCT00052078|Primary|Clinical Global Impression - Improvement Scale|The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.|Measured at Week 12||||percentage of participants||95% Confidence Interval|Number
2852483|NCT00051636|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||Participants|||Number
2852484|NCT00051636|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||Participants|||Number
2852485|NCT00051636|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.|||Participants|||Number
2852486|NCT00051636|Secondary|Change in Pain Interference Score|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||Units on a scale||Standard Deviation|Mean
2852487|NCT00051636|Secondary|Change in Pain Severity Score|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.|||Units on a scale||Standard Deviation|Mean
2852488|NCT00051636|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.|||Participants|||Number
2852489|NCT00051636|Secondary|Time to First Therapeutic Response|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.|||Days||Inter-Quartile Range|Median
2852490|NCT00051636|Secondary|Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10|The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||Percent change||Standard Deviation|Mean
2852491|NCT00051636|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.|||percent change||Standard Deviation|Mean
2852492|NCT00051636|Secondary|Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28|The percent change in serum alkaline phosphatase from baseline to day 28 was measured.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.|||percent change||Standard Deviation|Mean
2852493|NCT00051636|Primary|Number of Patients Who Achieve Therapeutic Response at 6 Months.|Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.|6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.|||participants|||Number
2852494|NCT00051558|Secondary|Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures|Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.|36 months|For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.|||participants|||Number
2852495|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
2852496|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
2852497|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
2852498|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers.|||percent||Standard Error|Mean
2852499|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers|||percent||Standard Error|Mean
2852500|NCT00051558|Secondary|Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
2852501|NCT00051558|Secondary|Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
2852502|NCT00051558|Secondary|Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.|||grams per square centimeters||Standard Error|Least Squares Mean
2852503|NCT00051558|Secondary|Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.|||grams per square centimeters||Standard Error|Least Squares Mean
2852504|NCT00051558|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|24 and 36 months and Endpoint at 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.|||grams per square centimeters||Standard Error|Least Squares Mean
2852505|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, and 18 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
2852506|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, 18, 24, 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.|||grams per square centimeters||Standard Error|Least Squares Mean
2852507|NCT00051558|Secondary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).|||grams per square centimeters||Standard Error|Least Squares Mean
2852508|NCT00051558|Primary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients.|||grams per square centimeters||Standard Error|Least Squares Mean
2852510|NCT00051363|Secondary|Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS)|Quality of life was measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI), which is an interview-administered instrument with high internal consistency and reliability. The SAQLI was designed to assess components identified as important to patients including daily functioning, social interactions, emotional functioning, symptoms experienced, and treatment-related symptoms. Items are scored on a seven-point scale, averaged (taking into account treatment-related symptoms), to yield a composite score between 1 and 7, where higher scores represent better quality of life.|diagnostic visit (baseline)|Analyses performed for group of participants with SAQLI data. Baseline demographics were generally similar (mean age, sex ratio, proportion of white participants, average body mass index), and participants in both groups had similar SAQLI scores at baseline, which are presented below.|||Units on a scale||Standard Deviation|Mean
2852511|NCT00051363|Secondary|Mood||Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Mood was dropped as a secondary outcome measure for analysis by our Core Team.||||||
2852512|NCT00051363|Secondary|Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS)|"Subjective sleepiness/alertness was measured using the Epworth Sleepiness Scale (ESS); the outcome variable was ESS Total Score (ESS-TS).~The ESS is a validated questionnaire (8 questions) that ask the chances of dozing off in specific situations. Summing the scores produces a scaled total score between 0 and 24, with higher numbers indicating more subjective sleepiness. The ESS was administered the evening before the polysomnogram (PSG), or overnight sleep study. Data reported here include questionnaires collected at the DX, 2M, and 6M visits."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||scores on a scale||Standard Deviation|Mean
2852513|NCT00051363|Secondary|Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL)|"Objective sleepiness/alertness was measured using the Maintenance of Wakefulness Test (MWT); the outcome variable was MWT Mean Sleep Latency (MWT-MSL).~The MWT was administered using four twenty-minute trials where the participant was asked to sit in a chair, in a quiet and dimly lit room, with instructions to stay awake. Trials were performed at 10 AM, Noon, 2 PM and 4 PM. The mean sleep latency was calculated using the 4 trials from a given visit, and required that at least 3 of the 4 trials were performed and validated."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||minutes||Standard Deviation|Mean
2852514|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD), SWMT- Mid-day Activation Index (SWMT-ActMD), and Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh).~These data are for variable #3: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||number of rule changes (dichotomized)||95% Confidence Interval|Mean
2852515|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.~These data are for variable #2: SWMT- Mid-day Activation Index (SWMT-ActMD)~SWMT-ActMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline (BL) using standard deviation units. It is computed as the difference from BL relative to EEG power spectral variables (decibels) measured during the easier vs. more difficult working memory (WM) tasks. A positive activation sub-score indicates a larger cortical neuronal population was recruited to perform the more difficult WM task relative to BL, while a negative score indicates a smaller population was recruited."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||score on a scale||95% Confidence Interval|Mean
2852516|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.~These data are for variable #1: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)~SWMT-BehMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the difference from baseline relative to measures of working memory (WM) task performance accuracy (percent correct) and mean and standard deviation of reaction time (milliseconds). High-load WM tasks receive twice the weight of the low-load WM tasks."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||score on a scale||95% Confidence Interval|Mean
2852517|NCT00051363|Secondary|Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec)|The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. One of the selected variables came from the domain of Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec).|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||number of words recalled||95% Confidence Interval|Mean
2852518|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #3: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||milliseconds||95% Confidence Interval|Mean
2852519|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #2: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||milliseconds||95% Confidence Interval|Mean
2852520|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #1: Pathfinder Number- Reaction Time (PN-RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).|||seconds||95% Confidence Interval|Mean
2852521|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.|||number of words recalled||95% Confidence Interval|Mean
2852522|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.|||seconds||95% Confidence Interval|Mean
2852523|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD)~SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness)."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.|||score on a scale||95% Confidence Interval|Mean
2852539|NCT00050167|Secondary|Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes|Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.|7 years|||||||
2852524|NCT00051168|Primary|Mean Intraocular Pressure|"Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.~All IOP measurements were performed with a Goldmann applanation tonometer."|At 5 years.||||millimeters mercury (mm Hg)||Standard Deviation|Mean
2852525|NCT00051025|Secondary|Time-to-Treatment Failure||From start of first treatment|||||||
2852526|NCT00051025|Secondary|Duration of Response|The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.|From beginning of response to time of relapse|Intent-to-treat. Please note: Data represent 1 subject in each treatment group who responded.|||Days|||Number
2852527|NCT00051025|Primary|Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.|Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy|24 Weeks|Intent-to-treat|||Participants|||Number
2852528|NCT00050986|Secondary|Progression-free Survival (Phase II)|Efficacy measured by 6 month progression-free survival assessment.|6 months|||||||
2852529|NCT00050986|Primary|Maximal Tolerating Dose (MTD for Phase I)|"Phase I Dose limiting toxicity evaluation at end of first cycle based on blood tests every two weeks and participants' subjective and objective symptoms.~Start Dose Level 100 mg/m² Temozolomide once daily + 400 mg ZARNESTRA twice daily; Dose Level 1 100 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 2 150 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 3 150 mg/m² Temozolomide once daily + 600 mg ZARNESTRA twice daily; Dose Level 4 150 mg/m² Temozolomide once daily + 800 mg ZARNESTRA twice daily"|End of first cycle (4 weeks) evaluation|As treated.|||participants|||Number
2852530|NCT00050960|Primary|Overall Survival||From date of randomization to date of death|Intent-to-Treat (ITT)|||Months||Full Range|Median
2852531|NCT00050778|Secondary|Percent Change From Baseline in MRI T2 Lesion Volume at Year 3|Percent change in lesion volume at Year 3 was calculated from MRI-T2-weighted scans as: 100*([lesion volume at Year 3] minus [lesion volume at Baseline]) divided by [lesion volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T2 lesion volume at Baseline and Year 3.|||percent change||Standard Deviation|Mean
2852532|NCT00050778|Secondary|Percent Change From Baseline in T1 Cerebral Volume at Year 3|Magnetic resonance imaging (MRI) T1 was used to determine rate of cerebral atrophy (decrease in cerebral/brain volume). Partial brain volumes were measured using the technique of Losseff et al. (1996). Percent change in cerebral volume at Year 3 was calculated from MRI-T1-weighted scans as: 100*([brain volume at Year 3] minus [brain volume at Baseline]) divided by [brain volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T1 brain volume at Baseline and Year 3.|||percent change||Standard Deviation|Mean
2852533|NCT00050778|Secondary|Probability of Participants Who Were Relapse Free at 3 Years After Initial Treatment|Participants were considered relapse free at Year 3 if they did not experience a relapse between randomization and study completion at 36 months. Participants who discontinued early were considered relapse free if they did not experience a relapse prior to discontinuation. Probability of participants who were relapse free at Year 3, estimated using the KM method, was reported.|Year 3|FAS population included all randomized participants who had correct diagnosis of MS at entry.|||probability of participants||95% Confidence Interval|Number
2852534|NCT00050778|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated using a Poisson regression model with observed number of relapses as a dependent variable, the log total amount of follow-up from date of randomization for each participant as an offset variable and treatment group indicator as a covariate.|Up to 3 years|FAS population included all randomized participants who had correct diagnosis of MS at entry.|||relapses per participant per year||95% Confidence Interval|Number
2852535|NCT00050778|Primary|Probability of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseline score of 1.0 or more; and the increase persisted for at least next the 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Probability of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 3 years|Full Analysis Set (FAS) population included all randomized participants who had correct diagnosis of MS at entry.|||probability of participants with SAD||95% Confidence Interval|Number
2852536|NCT00050622|Secondary|Treatment Satisfaction|Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).|End of Treatment||||Units on scale||Standard Deviation|Mean
2852537|NCT00050622|Primary|Classroom Behavior|Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.|Daily for 45 days||||Percentage of Work Completed||Standard Deviation|Mean
2852538|NCT00050622|Primary|Social Behavior-Negative Verbalizations|Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.|Daily for 45 days||||Number of Observed Behaviors||Standard Deviation|Mean
2852540|NCT00050167|Secondary|Proportion of Participants With Pathological Complete Response|Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.|7 Years|||||||
2852541|NCT00050167|Primary|Percentage of Participants With Reoccurrence|Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).|Median of 50 months|"(WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis.~(DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis."|||participants||95% Confidence Interval|Log Mean
2852542|NCT00050089|Secondary|Number of Participants With New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years||||participants|||Number
2852543|NCT00050089|Secondary|Number of Participants With a New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years||||participants|||Number
2852544|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to one of the four interventions (339 via the 2X2 factorial design)|||participants|||Number
2852545|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to No ARDFP or ARDFP (339 via the 2X2 factorial design and 0 via the UK Option Scheme)|||participants|||Number
2852546|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to Standard-ART or Mega-ART (339 via the 2X2 factorial design and 29 via the UK Option Scheme)|||participants|||Number
2852547|NCT00050011|Secondary|Rate of Change From Baseline in Total Hip BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population|||g/sq. cm/month||95% Confidence Interval|Mean
2852548|NCT00050011|Secondary|Rate of Change From Baseline in Lumbar Spine (L1-L4) BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population|||g/sq cm/month||95% Confidence Interval|Mean
2852549|NCT00050011|Secondary|Time to Disease Recurrence/Relapse|The median time to disease progression was assessed by Kaplan-Meier analysis. The Principal Investigator assessed each participant for disease recurrence at each visit. Further testing was performed at the discretion of the Principal Investigator and as clinically indicated. Disease progression was defined as chest wall and/or regional recurrence confirmed by positive cytology or biopsy, and/or distance recurrence of the 1) skin, subcutaneous tissue, and lymph nodes (other than local or regional), 2) bone marrow, 3) lung, 4) skeleton 5) liver and 6) central nervous system confirmed by positive cytology, biopsy, aspirate or radiology as appropriate.|over 5 years|ITT population|||months||95% Confidence Interval|Median
2852550|NCT00050011|Secondary|Incidence Rate of All Clinical Fractures|The number of participants who experienced a clinical fracture at month 36 was assessed. Initial x-ray (both AP and lateral views) of the lumbar and thoracic spine were performed at baseline to exclude participants with evidence of fracture. In addition, repeated bone scan and/or x-ray were performed at the Principal Investigator's discretion during the course of the study to confirm evidence of clinical fracture, or at month 36 if there was no evidence of clinical fracture (lumbar and thoracic spine - lateral view). X-ray films were sent to a central reader.|3 years|ITT population|||Participants|||Number
2852551|NCT00050011|Secondary|Percent Change From Baseline in Biochemical Markers of Bone Turnover, Serum N-Telopeptide (sNTX) and Bone-specific Alkaline Phosphatase (BSAP)|Blood samples from a subset of participants (231 participants in total) were collected to measure the sNTX and BSAP. Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from months 6 and 9 were carried forward to month 12. Data prior to month 6 were not carried forward. Missing data beyond month 12 were not imputed by LOCF.|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population|||Percentage of biochemical markers||Standard Deviation|Mean
2852552|NCT00050011|Secondary|Percent Change From Baseline in Total Hip BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.~Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward."|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population|||Percentage of BMD||Standard Deviation|Mean
2852553|NCT00050011|Secondary|Percent Change From Baseline in Lumbar Spine (L1-L4) BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.~Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data beyond month 12 were not imputed by LOCF."|Baseline, 2 years, 3 years, 5 years|ITT population|||Percentage of BMD||Standard Deviation|Mean
2853282|NCT00029536|Secondary|Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.|Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.|9 years||||percentage of participants|||Number
2852554|NCT00050011|Primary|Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)|Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.|Baseline, 12 months|Intent to treat (ITT population) was used. The ITT population contained all patients in the safety population for whom at least one post-baseline efficacy measurement was collected.|||Percentage of BMD||Standard Deviation|Mean
2852555|NCT00049842|Secondary|Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.|"Definitions:~Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).~Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
2852556|NCT00049842|Secondary|Mean Change in the METAVIR Activity Score (Using a Continuous Scale)|"The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.~Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR activity score.|||Units on a scale||Standard Deviation|Mean
2852557|NCT00049842|Secondary|The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline|"Definitions:~Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).~Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
2852558|NCT00049842|Secondary|Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)|"The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.~Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR fibrosis score.|||Units on a scale||Standard Deviation|Mean
2852559|NCT00049842|Secondary|Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)|"Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).~Changes in liver inflammation defined as follows:~Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
2852560|NCT00049842|Primary|Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).|"Definitions:~Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).~Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is Intent-to-Treat (ITT). Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.|||Participants|||Number
2852561|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337|All DB participants treated on study who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 68 participants were not evaluated for anti-abatacept anti-bodies on study.|||participants|||Number
2852562|NCT00048932|Primary|OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 365 to Day 1821|All Treated Population.|||participants|||Number
2853051|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 12|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Inter-Quartile Range|Median
2852563|NCT00048932|Primary|OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. N=Number of Participants Analyzed, n=number of participants with measurements at time point|||participants|||Number
2852564|NCT00048932|Primary|OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for electrolyte abnormalities.|||participants|||Number
2852565|NCT00048932|Primary|OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for liver function abnormalities.|||participants|||Number
2852566|NCT00048932|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population.|||participants|||Number
2852567|NCT00048932|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 365 to Day 1821|All Treated Participants, all participants who received at least 1 dose of study medication|||participants|||Number
2852568|NCT00048932|Primary|Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 365 to Day 1,821|All Treated Participants|||participants|||Number
2852569|NCT00048932|Primary|DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.|All Treated Population.|||participants|||Number
2852570|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 29, 57, 85, 113,169, 281, 365|All participants treated during DB who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 561 participants were not evaluated for anti-abatacept anti-bodies during the DB.|||participants|||Number
2852571|NCT00048932|Primary|DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper level of normal; BL=baseline.Marked abnormality criteria: High alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; high aspartate aminotransferase (AST): >3* ULN (80 U/L), or if BL>ULN then use >4* BL; high alanine aminotransferase (ALT): >3* ULN (34-47 U/L), or if BL>ULN then use >4* BL; high G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; high bilirubin: >2* ULN, or if BL>ULN then use >4* BL; high blood urea nitrogen (BUN): >2* BL; high creatinine: >1.5* BL (ULN 14.6 pg/mg. AST ULN=80 U/L; ALT ULN=34-47 U/L;creatinine ULN=14.6 pg/mg.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. Two participants in the ABA group and 3 participants in the PLA group were not evaluated for blood chemistry abnormalities due to data unavailability (missing data).|||participants|||Number
2852572|NCT00048932|Primary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant in each group was not evaluated for hematology abnormalities due to data unavailability (missing data).|||participants|||Number
2852573|NCT00048932|Primary|DB; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication|||participants|||Number
2852574|NCT00048932|Primary|Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication|||participants|||Number
2852575|NCT00048815|Primary|Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment|We expect that subjects treated for Minor Depression for 12 weeks with either St. John's Wort or citalopram will have similar safety profiles to subjects treated with placebo, and will not differ by more than 20% in rates of adverse side effects (e.g., nausea, headache, insomnia, hypersomnia, diarrhea) from subjects treated with placebo. This was measured by the number of adverse events (physical symptoms) emerging or worsening during 12 weeks of treatment.|Change from Baseline to Week 12||||Number of events||Standard Deviation|Mean
2852576|NCT00048815|Primary|Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)|We expect that subjects with minor depression treated for 12 weeks with St. John's Wort or citalopram will have significantly greater reduction in depressive symptom severity than those treated with placebo. This will be measured by blind ratings on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) which has a total score range from 0 to 84 with 0 being not depressed at all and 84 being the most depressed. The change will be calculated by subtracting the Week 12 score from the Baseline score.|Change from Baseline to Week 12||||units on a scale||Standard Error|Least Squares Mean
2852577|NCT00048581|Secondary|Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL (Day 1) to Day 1821|All participants treated on study with at least one post-baseline immunogenicity measurement.|||participants|||Number
2852578|NCT00048581|Secondary|OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852579|NCT00048581|Secondary|OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852580|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||units on a scale||Standard Error|Mean
2852581|NCT00048581|Secondary|OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852582|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||units on a scale||Standard Error|Mean
2852583|NCT00048581|Secondary|OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852584|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852585|NCT00048581|Secondary|OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852586|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852587|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2853283|NCT00029536|Primary|Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency|Percent of women who show a greater than 50% decline in average daily seizure frequency|9 years||||percentage of participants|||Number
2852588|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852589|NCT00048581|Secondary|OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852590|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852591|NCT00048581|Secondary|OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852592|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852593|NCT00048581|Secondary|OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852623|NCT00048581|Primary|OL; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From first day of OL to 5.5 years|All treated participants|||participants|||Number
2852594|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852595|NCT00048581|Secondary|OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852596|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852597|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852598|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852599|NCT00048581|Secondary|OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852624|NCT00048581|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL to Day 169|All treated participants in the double-blind period with at least 1 post-baseline immunogenicity result|||participants|||Number
2853379|NCT00023595|Secondary|H01: All-cause Mortality, Heart Transplant or LVAD|LVAD=Left Ventricular Assist Device|10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2852600|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852601|NCT00048581|Secondary|OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852602|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||pg/ml||Standard Error|Mean
2852603|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||pg/ml||Standard Deviation|Mean
2852604|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mm/hr||Standard Error|Mean
2852605|NCT00048581|Secondary|OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mm/hr||Standard Deviation|Mean
2852606|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mg/dL||Standard Error|Mean
2852607|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mg/dL||Standard Deviation|Mean
2853380|NCT00023595|Secondary|H02: All-cause Mortality, Heart Transplant or LVAD||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2852608|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||IU/ml||Standard Error|Mean
2852609|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Time-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||IU/ml||Standard Deviation|Mean
2852610|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL|HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852611|NCT00048581|Secondary|OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852612|NCT00048581|Secondary|OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL|The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants analyzed, n=number of participants with measurements at visit.|||participants|||Number
2852613|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852614|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852615|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Error|Mean
2852616|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852617|NCT00048581|Secondary|OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
2852618|NCT00048581|Secondary|OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
2852619|NCT00048581|Primary|OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.|BL, Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.|||mg/dL||Standard Error|Mean
2852620|NCT00048581|Primary|OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.|Baseline and Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.|||mg/dL||Standard Deviation|Mean
2852621|NCT00048581|Primary|OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From first day of OL to 5.5 years|All treated participants|||participants|||Number
2852622|NCT00048581|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From first day of OL to 5.5 years|All treated participants|||participants|||Number
2852820|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE BSA Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE BSA Phase||||Participants|||Number
2852625|NCT00048581|Primary|Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From first day of OL to 5.5 years|All treated participants|||participants|||Number
2852626|NCT00048581|Secondary|DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
2852627|NCT00048581|Secondary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
2852628|NCT00048581|Secondary|DB; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
2852629|NCT00048581|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From BL up to database lock for DB period (6/2/2004)|All treated participants|||participants|||Number
2852630|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Error|Mean
2852631|NCT00048581|Secondary|DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
2852632|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||units on a scale||Standard Deviation|Mean
2852985|NCT00044512|Secondary|Time to Response|Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
2852633|NCT00048581|Secondary|DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||units on a scale||Standard Deviation|Mean
2852634|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
2852635|NCT00048581|Secondary|DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
2852636|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.|BL, Day 85|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Error|Mean
2852637|NCT00048581|Secondary|DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||Units on a Scale||Standard Deviation|Mean
2852638|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
2852639|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||ng/ml||Standard Error|Mean
2853011|NCT00043979|Secondary|Early Post Transplantation Relapse|Participants who experienced recurrence or progression of disease following transplant.|up to 300 days|One out of 23 participants did not have a recurrence, thus was excluded from analysis.|||Days||Full Range|Median
2852640|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||ng/ml||Standard Deviation|Mean
2852641|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169|The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||pg/ml||Standard Error|Mean
2852642|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169|Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||pg/ml||Standard Deviation|Mean
2852643|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852644|NCT00048581|Secondary|DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||mg/dL||Standard Deviation|Mean
2852645|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852646|NCT00048581|Secondary|DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852698|NCT00048568|Secondary|Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||pg / mL||Standard Deviation|Mean
2853012|NCT00043979|Secondary|Median Time to Reach a Platelet Count of 50,000/mm(3)|Days for participants to achieve a platelet count of 50,000/mm(3).|up to 43 days||||Days||Full Range|Median
2852647|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852648|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852649|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component|A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions evaluated on a 4-point scale:0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852650|NCT00048581|Secondary|DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component|HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852651|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component|Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852652|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component|The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
2852653|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852654|NCT00048581|Secondary|DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.|||swollen joints||Standard Deviation|Mean
2852655|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.|||percentage of change from BL||Standard Error|Mean
2852656|NCT00048581|Secondary|DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.|||tender joints||Standard Deviation|Mean
2852657|NCT00048581|Secondary|DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, and 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit|||participants|||Number
2852658|NCT00048581|Primary|DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||participants|||Number
2852659|NCT00048581|Primary|Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized participants who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.|||participants|||Number
2852660|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852699|NCT00048568|Primary|Mean Change From BL in Serum Electrolytes in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mEq/L||Standard Error|Mean
2852661|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852662|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852663|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852664|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852665|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852666|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852667|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852668|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852669|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852670|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852671|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852672|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852673|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852674|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852675|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852676|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852677|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852678|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.|||Units on a Scale||Standard Error|Mean
2852679|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852680|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852681|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2853013|NCT00043979|Secondary|Median Time to Reach Absolute Neutrophil Count of 500/mm(3)|Days for participants to achieve a neutrophil count of 500/mm(3).|up to 12 days||||Days||Full Range|Median
2852682|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852683|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852684|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852685|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852686|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852687|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852688|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852689|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852690|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852691|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852692|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852693|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852694|NCT00048568|Secondary|Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period|The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||ng / mL||Standard Error|Mean
2852695|NCT00048568|Secondary|Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||ng / mL||Standard Error|Mean
2852696|NCT00048568|Secondary|Mean Change From BL in RF in the DB Period|The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Error|Mean
2852697|NCT00048568|Secondary|Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||pg / mL||Standard Error|Mean
2852700|NCT00048568|Primary|Mean BL Serum Electrolytes in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mEq/L||Standard Deviation|Mean
2852701|NCT00048568|Primary|Mean Change From BL in Select Laboratory Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
2852702|NCT00048568|Primary|Mean BL Select Laboratory Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg/dL||Standard Deviation|Mean
2852703|NCT00048568|Primary|Mean Change From BL in Liver Function Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||U/L||Standard Error|Mean
2852704|NCT00048568|Primary|Mean BL Liver Function Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||U/L||Standard Deviation|Mean
2852705|NCT00048568|Primary|Mean Change From BL in White Blood Cells in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^3 c/uL||Standard Error|Mean
2852706|NCT00048568|Primary|Mean BL White Blood Cells in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^3 c/uL||Standard Deviation|Mean
2852707|NCT00048568|Secondary|Mean Change From BL in Limitations on Activities of Daily Living in the OL Period|The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Days||Standard Error|Mean
2852708|NCT00048568|Secondary|Mean BL Limitations on Activities of Daily Living in the OL Period|Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Days||Standard Deviation|Mean
2852709|NCT00048568|Secondary|Mean Change From BL in Sleep Quality in the OL Period|The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852731|NCT00048568|Primary|Mean BL Platelet Count in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^9 c/L||Standard Deviation|Mean
2852710|NCT00048568|Secondary|Mean BL Sleep Quality in the OL Period|Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852711|NCT00048568|Secondary|Mean Change From BL in Fatigue in the OL Period|The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852712|NCT00048568|Secondary|Mean BL Fatigue in the OL Period|Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852713|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852714|NCT00048568|Secondary|Mean BL Mental Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852715|NCT00048568|Secondary|Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852716|NCT00048568|Secondary|Mean BL Vitality Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852717|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852718|NCT00048568|Secondary|Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852719|NCT00048568|Secondary|Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852720|NCT00048568|Secondary|Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852721|NCT00048568|Secondary|Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852722|NCT00048568|Secondary|Mean BL General Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2853014|NCT00043979|Secondary|Number of Participants With Acute and Chronic GVHD|Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100.|up to 5 years or death||||participants|||Number
2853015|NCT00043979|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16.5 months||||Participants|||Number
2852723|NCT00048568|Secondary|Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852724|NCT00048568|Secondary|Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852725|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852726|NCT00048568|Secondary|Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852727|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852728|NCT00048568|Primary|Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||g/dL||Standard Error|Mean
2852729|NCT00048568|Primary|Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||g/dL||Standard Deviation|Mean
2852730|NCT00048568|Primary|Mean Change From BL in Participant Platelet Count in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||10^9 c/L||Standard Error|Mean
2852732|NCT00048568|Primary|Mean Change From BL in Participant Hematocrit in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Percentage Blood Volume Occupied by RBCs||Standard Error|Mean
2852733|NCT00048568|Primary|Mean BL Hematocrit in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Percentage of Red Blood Cells||Standard Deviation|Mean
2852734|NCT00048568|Primary|Number of Participants Experiencing AEs of Special Interest in the OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
2852735|NCT00048568|Primary|Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period|Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.|Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.|All treated participants entering the OL period.|||Participants|||Number
2852736|NCT00048568|Secondary|Mean BL Physical Function Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852737|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852738|NCT00048568|Secondary|Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852739|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2853031|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
2852740|NCT00048568|Secondary|Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852741|NCT00048568|Secondary|BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period|Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852742|NCT00048568|Secondary|Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2852743|NCT00048568|Primary|Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period|Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.|Day 1 to Day 1,821|Participants with serum samples available for evaluation of titers to abatacept.|||Participants|||Number
2852744|NCT00048568|Primary|Mean Change From BL in Immunoglobulins in the OL Period||BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).|||mg / mL||Standard Error|Mean
2852745|NCT00048568|Primary|Mean BL Immunoglobulins Over Time in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.|BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).|||mg / mL||Standard Deviation|Mean
2852746|NCT00048568|Secondary|Mean Change From BL in DAS-28 ESR Over Time in the OL Period|Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Error|Mean
2852747|NCT00048568|Secondary|Mean BL DAS-28 ESR Over Time in the OL Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Deviation|Mean
2852748|NCT00048568|Secondary|Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period|Change from baseline in participant were calculated at all study visits in the DB and OL periods.|BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Error|Mean
2853052|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 12|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12|||Percent change||Inter-Quartile Range|Median
2852749|NCT00048568|Secondary|Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period|Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Deviation|Mean
2852750|NCT00048568|Secondary|Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time|The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (> 5.1); low (≤ 3.2); remission (< 2.6).|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2852751|NCT00048568|Secondary|Number of ACR 70 Responders in the DB and OL Periods|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2852752|NCT00048568|Secondary|Number of ACR 50 Responders in the DB and OL Periods|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2852753|NCT00048568|Secondary|Number of ACR 20 Responders in the DB and OL Periods|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2852754|NCT00048568|Secondary|Participant RF Seroconversion in the OL Period|This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||Participants|||Number
2852755|NCT00048568|Secondary|Mean Change From BL in ESR in the OL Period|Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Error|Mean
2852756|NCT00048568|Secondary|Mean BL ESR and CRP Levels in the OL Period|Mean baseline values are reported for each cohort at each time point.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||IU / mL||Standard Deviation|Mean
2852757|NCT00048568|Secondary|Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Aspartate Aminotransferase (AST) >3 * ULN or if BL > ULN then use >4 *BL; Alanine Aminotransferase (ALT) >3 * ULN or if BL > ULN then use > 4 * BL; Creatinine > 1.5 * BL.|Day 1 to Day 365|All treated participants in the DB period.|||Participants|||Number
2853112|NCT00038948|Primary|Nankivell Glomerular Filtration Rate (GFR)|Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.|52 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.|||mL/min||Standard Error|Mean
2852758|NCT00048568|Secondary|Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365|All treated participants in the DB period.|||Participants|||Number
2852759|NCT00048568|Secondary|Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period||Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.|||Participants|||Number
2852760|NCT00048568|Secondary|Number of New Tender Joints and Number of New Swollen Joints in the DB Period|Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.|Day 169, Day 365|These data were not summarized as it was determined that no meaningful information would be obtained.|||Joints|||Number
2852761|NCT00048568|Secondary|Number of Participants With Immunogenicity to Abatacept in the DB Period|Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.|Day 1 to Day 365|Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.|||Participants|||Number
2852762|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.|||Units on a Scale||Standard Error|Mean
2852763|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.|||Units on a Scale||Standard Error|Mean
2852764|NCT00048568|Secondary|Mean BL Individual Components of the HAQ DI at Day 169 and Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852765|NCT00048568|Secondary|Participants Experiencing AEs of Special Interest in the DB Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 1 to Day 365|All treated participants in the DB period.|||Participants|||Number
2852766|NCT00048568|Secondary|Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period|All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.|Day 1 to Day 365|All randomized and treated participants.|||Participants|||Number
2852767|NCT00048568|Primary|Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period|Glucose: < 65 mg/dL or > 220 mg/dL; Fasting Glucose: <0.8 * LLN or > 1.5 * ULN or if BL < LLN then use < 0.8 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Total protein: < 0.9 * LLN or 1.1 * ULN or if BL < LLN then use 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Albumin: < 0.9 * LLN or if BL < LLN then use 0.75 * BL; Uric acid: > 1.5 * ULN or if BL > ULN then use > 2.0 * BL. All urinalysis abnormalities were defined as: if missing BL then use >= 2 or if value >=4, or if BL = 0 or 0.5 then use >= 2, or if BL = 1.0 then use >= 3, or if BL = 2.0 then use >=4.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
2853032|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
2852768|NCT00048568|Primary|Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period|Sodium < 0.9 * LLN or > 1.05 * ULN or if BL < LLN then use < 0.95 * BL or > ULN or if BL > ULN then use >1.05 *BL or < LLN; Potassium: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use < 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Chloride: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use <0.9 * BL or >ULN or if BL > ULN then use > 1.1 * BL or < LLN; Calcium <0.8 * LLN or > 1.2 * ULN or if BL < LLN then use <0.67 * BL or > ULN or if BL > ULN then use > 1.3 * BL or < LLN.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
2852769|NCT00048568|Primary|Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
2852770|NCT00048568|Primary|Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
2852771|NCT00048568|Primary|Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 365 to Day 2,185|All treated participants in the OL period.|||Participants|||Number
2852772|NCT00048568|Secondary|Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.|BL (Day 0), Day 365|This analysis was not completed.|||Participants|||Number
2852773|NCT00048568|Secondary|Number of Participants Discontinuing in the DB Period|Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.|Day 1 to Day 169, Day 170 to Day 365|All randomized and treated participants in the DB period.|||Participants|||Number
2852774|NCT00048568|Secondary|ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period|CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||IU / mL||Standard Deviation|Mean
2852775|NCT00048568|Secondary|ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period|Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852776|NCT00048568|Secondary|ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852777|NCT00048568|Secondary|ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852778|NCT00048568|Secondary|ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period|Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852779|NCT00048568|Secondary|ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period|The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||joints||Standard Deviation|Mean
2852780|NCT00048568|Secondary|ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period|Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Joints||Standard Deviation|Mean
2852781|NCT00048568|Secondary|Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period.|||mg / mL||Standard Error|Mean
2852782|NCT00048568|Secondary|Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Deviation|Mean
2852783|NCT00048568|Secondary|Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period|The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|BL (Day 0), Day 169, Day 365|Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.|||mg / mL||Standard Error|Mean
2852784|NCT00048568|Secondary|Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period|The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||mg / mL||Standard Deviation|Mean
2852785|NCT00048568|Secondary|Participants in the DB Period Achieving an Extended Major Clinical Response|An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 1 to Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852786|NCT00048568|Secondary|Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Error|Mean
2852796|NCT00048568|Secondary|ACR 50 Responders at Day 365|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852787|NCT00048568|Secondary|Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852788|NCT00048568|Secondary|Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Units on a Scale||Standard Deviation|Mean
2852789|NCT00048568|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to Day 365|All treated subjects in the DB period.|||Participants|||Number
2852790|NCT00048568|Secondary|Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365|The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (>5.1); low (≤3.2); remission (<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365, Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.|||Units on a Scale||Standard Deviation|Mean
2852791|NCT00048568|Secondary|Number of Participants Achieving Major Clinical Response By Day 365|A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.|Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852792|NCT00048568|Secondary|ACR 70 Responders in the DB Period|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852793|NCT00048568|Secondary|ACR 70 Responders at Day 365|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852794|NCT00048568|Secondary|ACR 70 Responders at Day 169|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852795|NCT00048568|Secondary|ACR 50 Responders in the DB Period|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852797|NCT00048568|Secondary|ACR 50 Responders at Day 169|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852798|NCT00048568|Secondary|ACR 20 Responders in the Double-Blind (DB) Period|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852799|NCT00048568|Secondary|ACR 20 Responders at Day 365|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852800|NCT00048568|Secondary|BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period|This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|BL (Day 365)|All treated participants in the OL period (treatment groups represent treatment received in the DB period).|||Participants|||Number
2852801|NCT00048568|Secondary|Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment|Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.|BL (Day 0)|All randomized and treated participants in the DB period.|||Units on a Scale||Standard Deviation|Mean
2852802|NCT00048568|Secondary|Mean Number of Tender Joints and Swollen Joints at DB BL||BL (Day 0)|All randomized and treated participants in the DB period.|||Joints||Standard Deviation|Mean
2852803|NCT00048568|Primary|Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Units on a Scale||Standard Deviation|Mean
2852804|NCT00048568|Primary|Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852805|NCT00048568|Primary|Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.|||Participants|||Number
2852806|NCT00048893|Secondary|Number of Participants With a Clinical Response|Defined as measurable disease (any solid lesion that can be measured accurately in at least one dimension), evaluable disease (disease not readily measurable but can be clinically assessed), complete response (complete disappearance of all measurable and evaluable disease), partial response (decrease of greater than or equal to 50%), stable disease (any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions), or progressive disease (greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease).|At the beginning of each cycle of chemotherapy (every 4 weeks)|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Participants|||Number
2853113|NCT00038857|Primary|Number of Participants With Absolute Neutrophil Count Engraftment|Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant.|Day 0 up to Day 30|Analysis per protocol.|||participant|||Number
2852807|NCT00048893|Secondary|Number of Participants With an Immune Response as a Result of the Salvage Immunization Schedule|Patients showing disease progression or recurrence at any point after the start of the early immunizations series may continue on study in accordance to the off study criteria and will be receiving monthly rF immunizations for a total of 12 months or until further disease progression meets the off study criteria. Immune response as evidenced by change in lymphocyte subsets in the blood.|6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapy|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Participants|||Number
2852808|NCT00048893|Secondary|Number of Months of Progression Free Survival|The time period a participant remains free from progressive disease. Progressive disease (PD) is defined as a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease or the appearance of new disease or an increase in evaluable disease.|After the immune depletion cycle|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Months|||Number
2852809|NCT00048893|Secondary|Immune Response to the Vaccine in Those Patients With Late Recovery of Thymic Function|It is expected that delayed administration of a vaccine will result in enhancement of immune response to the vaccine in those patients with later recovery of thymic function as evidenced by change in lymphocyte subsets in the blood.|2 years|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Cells/L|||Number
2852810|NCT00048893|Secondary|Log Change of CD4 CEA-specific Immune Responses and Their Kinetics as a Surrogate Marker for Clinical Anti-tumor Activity of the Vaccines|Response is evaluated by CD4 response to CEA soluble protein. The log change in precursor frequencies will be calculated between values obtained at baseline and five months post immune depletion. By flow cytometry of peripheral blood lymphocyte frequency of potential killer cells directed to the CEA protein.|Baseline and 5 months post immune depletion|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||log change of CD4 CEA specific precursor|||Number
2852811|NCT00048893|Secondary|Log Change in Precursor Frequency as Measured by Elispot.|The log change in CEA-specific T cell precursor frequency will be calculated between values obtained at baseline and 5 months post immune depletion. A change equal to 1.0 standard deviation (SD) of the log change is significant.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||log change in CEA-specific T cell precur|||Number
2852812|NCT00048893|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|91 months||||Participants|||Number
2852813|NCT00048893|Primary|Event-free Survival as Measured by Clinical Evaluation and Tumor Measurements by Imaging|Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.|||Months|||Number
2852814|NCT00048737|Primary|Number of Participants With Graft Failure|Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.|100 days||||participants|||Number
2852815|NCT00048724|Secondary|Time to Observation of the Disease Progression Experienced by a Subject|Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.|||Participants|||Number
2852816|NCT00048724|Primary|Time to Observation of the First Clinical Event Experienced by a Subject|Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.|||Participants|||Number
2852817|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE FD Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE FD Phase||||Years||Standard Deviation|Mean
2852818|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE FD Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE FD Phase||||Participants|||Number
2852819|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE BSA Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE BSA Phase||||Years||Standard Deviation|Mean
2852821|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).|Final Visit (up to 224 weeks of OLE FD phase)|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
2852822|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 112|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
2852823|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 48|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
2852824|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Baseline|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.|||Participants|||Number
2852825|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 104|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.|||Participants|||Number
2852826|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 56|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.|||Participants|||Number
2852827|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Open-Label Lead-In Phase Baseline|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.|||Participants|||Number
2852828|NCT00048542|Secondary|Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase|Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.|||mg/dL||Standard Error|Mean
2852829|NCT00048542|Secondary|Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.|||Units on a scale||Standard Error|Mean
2852830|NCT00048542|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.|||Units on a scale||Standard Error|Mean
2852831|NCT00048542|Secondary|Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 70% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
2852832|NCT00048542|Secondary|Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 50% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
2852833|NCT00048542|Secondary|Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
2852834|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum.|||Percent participants w/o disease flare|||Number
2852835|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum.|||Percent participants w/o disease flare|||Number
2852836|NCT00048542|Secondary|Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase|Subjects met criteria for disease flare if they had >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16 to Week 48 (32 Weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare.|||Participants|||Number
2852837|NCT00048542|Secondary|Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JRA core set criteria, and >= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.|||Participants|||Number
2853033|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
2852838|NCT00048542|Primary|Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase|The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.|||Participants|||Number
2852839|NCT00048347|Primary|Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)|The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).|Baseline, Week 12||||Percent of participants|||Number
2852840|NCT00048165|Secondary|Number of Participants With Malignancies and Opportunistic Infections|The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).|||participants|||Number
2852841|NCT00048165|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).|||participants|||Number
2852842|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.|||participants|||Number
2852843|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.|||participants|||Number
2852844|NCT00048165|Secondary|Median Change From Baseline for LDL/HDL Ratio||From Baseline (Day -2) to 3 months, and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||ratio||Full Range|Median
2852845|NCT00048165|Secondary|Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)|Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported.|From Baseline (Day -2) to 3 months and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified parameters are denoted by 'n'.|||mg/dL||Full Range|Median
2852855|NCT00048074|Secondary|Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.|||participants|||Number
2852846|NCT00048165|Secondary|Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT|The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.|||mg||Standard Deviation|Mean
2852847|NCT00048165|Secondary|Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT|The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
2852848|NCT00048165|Secondary|Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT|The median time to first acute rejection episode within first 6 months and 12 months PT was reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.|||days||Full Range|Median
2852849|NCT00048165|Secondary|Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT|The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
2852850|NCT00048165|Secondary|Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT|The survival of the graft and participants at 6,12 months and 3 years PT was reported|At 6 months, 12 months , 3 years PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
2852851|NCT00048165|Secondary|Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT|The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
2852852|NCT00048165|Secondary|Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up|Up to 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
2852853|NCT00048165|Primary|Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up.|Up to 6 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.|||participants|||Number
2852854|NCT00048074|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point. Only participants with data available for the indicated laboratory abnormality were analyzed.|||participants|||Number
2852856|NCT00048074|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852857|NCT00048074|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852858|NCT00048074|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852859|NCT00048074|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852860|NCT00048074|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852861|NCT00048074|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852862|NCT00048074|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percentage of participants|||Number
2852863|NCT00048074|Secondary|Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Absolute Change (ng/mL)||Standard Deviation|Mean
2852864|NCT00048074|Secondary|Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
2852865|NCT00048074|Secondary|Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Absolute Change (g/cm^2)||Standard Deviation|Mean
2852866|NCT00048074|Secondary|Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
2852867|NCT00048074|Secondary|Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Absolute Change (g/cm^2)||Standard Deviation|Mean
2852868|NCT00048074|Secondary|Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
2852869|NCT00048074|Primary|Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 12|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.|||Percent Change||Standard Deviation|Mean
2852870|NCT00048061|Secondary|Number Of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.|||Participants|||Number
2852871|NCT00048061|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Event|An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.|||Participants|||Number
2852872|NCT00048061|Secondary|Absolute Change In Baseline in Serum CTX to Months 12 and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||ng/ml||Standard Deviation|Mean
2852873|NCT00048061|Secondary|Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 3, 6, 12, 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2852874|NCT00048061|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852875|NCT00048061|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852876|NCT00048061|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852877|NCT00048061|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852878|NCT00048061|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852879|NCT00048061|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852880|NCT00048061|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
2852881|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.|Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||g/cm2||Standard Deviation|Mean
2852882|NCT00048061|Secondary|Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD|Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
2852883|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.|||g/cm2||Standard Deviation|Mean
2852884|NCT00048061|Secondary|Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.|From Baseline (Month 0) to Month 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.|||Percent change||Standard Deviation|Mean
2852885|NCT00048061|Primary|Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density|Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.|From Baseline (Month 0) to Month 12|The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.|||Percent change||Standard Deviation|Mean
2852886|NCT00048048|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure|Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1).|From Baseline (Day -28 to Day 1) to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2852887|NCT00048048|Secondary|Heart Rate Over Time|Heart rate was defined as the measure of heart beats per minute (bpm). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||bpm||Standard Deviation|Mean
2852888|NCT00048048|Secondary|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time|Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10^9 cells/L), platelets (100-550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||participants|||Number
2852889|NCT00048048|Secondary|Number of Participants With Any Serious Adverse Events and Any Adverse Events|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 125|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||participants|||Number
2852890|NCT00048048|Secondary|Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen|Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The ITT population was defined as all randomized participants. Maximum number of participants with available data was reported.|||Cells x10^3/UL||Inter-Quartile Range|Median
2852891|NCT00048048|Secondary|Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen|Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The ITT population was defined as all randomized participants. Maximum number of participants with available data was reported.|||g/dL||Inter-Quartile Range|Median
2852892|NCT00048048|Primary|The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes|The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants. Maximum number of participants with available data was reported.|||gram/deciliter (g/dL)||Inter-Quartile Range|Median
2852893|NCT00048035|Secondary|Mean Change in Pulse Rate|Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug|||BpM||Standard Deviation|Mean
2852894|NCT00048035|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||mm HG||Standard Deviation|Mean
2852895|NCT00048035|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
2852953|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
2852896|NCT00048035|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.|||Participants|||Number
2852897|NCT00048035|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.|||g/dL||Inter-Quartile Range|Median
2852898|NCT00048035|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.|||g/dL||Inter-Quartile Range|Median
2852899|NCT00047879|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 months||||Participants|||Number
2852900|NCT00047879|Secondary|Number of Participants With Complete or Partial Response|"Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan.~Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component.~Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions."|6 months|Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.|||Participants|||Number
2852901|NCT00047879|Primary|Progression-free Survival|"Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy.~Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles."|6 months|The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.|||Percent of participants|||Number
2852902|NCT00047697|Primary|Cognitive Assessment: CVLT|California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better|8 weeks||||percentage of correct answers||Standard Deviation|Mean
2852903|NCT00047697|Primary|Cognitive Assessment: EOWVT Standard Score|Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better|8 weeks||||units on a scale||Standard Deviation|Mean
2852904|NCT00047697|Primary|Cognitive Assessment: TMT|TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better|8 weeks||||seconds||Standard Deviation|Mean
2852905|NCT00047619|Primary|Pressure Ulcer Volume Measurement|Volume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing|study participation - up to 6 weeks||||cm^3||95% Confidence Interval|Mean
2852906|NCT00047619|Primary|Pressure Ulcer Geometry|Linear assessment of wounds|study participation - up to 6 weeks||||cm||95% Confidence Interval|Mean
2852907|NCT00047463|Secondary|Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea|The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization|prior to randomization|These are participants that were enrolled and assessed to determine if one night of baseline sleep study was sufficient to detect sleep apnea. This occurred prior to randomization. Five of the assessed participants were not randomized.|||Participants|||Number
2852908|NCT00047463|Secondary|Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP|Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP|10 weeks||||participants|||Number
2852909|NCT00047463|Primary|CPAP Adherence/Tolerance as Measured by Proportion of Nights Used|This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.|10 weeks||||proportion of nights used (total nights||Standard Deviation|Mean
2853114|NCT00038727|Secondary|Frailty|Description: The Cardiovascular Health Study Frailty score is based on 5 frailty characteristics: slow walking speed, low energy expenditure, exhaustion, weak grip strength, and unintentional weight loss.|Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.||2021-07-31|07/2021||||
2852910|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of US Participants With Marked/Severe Disease According to The CGI-S Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Marked or Severe disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites|||scores on a scale||Standard Deviation|Mean
2852911|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of United States (US) Participants With Mild/Moderate Disease According to The Clinical Global Impressions-Severity (CGI-S) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Mild or Moderate disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites|||scores on a scale||Standard Deviation|Mean
2852912|NCT00046475|Secondary|Convergent Validity of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA and the OHSA composite score were analyzed for convergent validity with the CGI-I-Clinician scores. The change from baseline in the CGI-I scores are correlated with the OHSA Item 1 score change from baseline and the OHSA composite score change from baseline for the subjects in the ITT population. Values shown are Spearman correlation coefficients.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||correlation coefficient|||Number
2852913|NCT00046475|Secondary|Responsiveness of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for responsiveness as a measure of validity. Assuming that subjects who received Placebo during Randomization Period 1 are stable between Visit 3A and Visit 5, and using them as the stable subjects, responsiveness was calculated as [(OH CFB in Midodrine group)-(OH CFB in Placebo group)]/(SD of OH CFB in Placebo group), where CFB is change from baseline, SD is the standard deviation of OH CFB of the stable subjects; the value reported is the quotient of this equation.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||quotient|||Number
2852914|NCT00046475|Secondary|Test Reliability of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for test-retest reliability as a measure of validity. Test-retest reliability is the Pearson product-moment correlation coefficient calculated between OHQ scores at Visit 3A (baseline measure) and OHQ scores at Visit 5 for the subjects who received Placebo during Randomization Period 1.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||correlation coefficient|||Number
2852915|NCT00046475|Secondary|Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire Scores|"The SF-36 consists of 36 items in eight domains: physical functioning, general health, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. Version 2 references one week ago for some questions. Raw scale scores for the SF-36 were transformed to a 0-100 scale with a higher score indicating a better quality of life. A positive change from baseline indicates that symptoms have improved. The SF-36 was completed at Visit 5 (Period 2) and Visit 6 (study completion) and compared to the score from Visit 3A (titration)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
2852916|NCT00046475|Secondary|Change From Baseline in Supine BP|Supine BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Supine BP was measured after the patient had been in the supine position for 5 minutes.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||mmHg||Standard Deviation|Mean
2852917|NCT00046475|Secondary|Change From Baseline in Standing Blood Pressure (BP)|Standing BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Standing BP was measured 3 minutes after the patient rose from the supine position or as soon as the patient indicated they needed to sit down. If the patient indicated he or she needed to sit down, the BP measurement was taken while in the standing position, before the patient sat down.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||mmHg||Standard Deviation|Mean
2852918|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Patient Version of The CGI-I Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||percent of participants|||Number
2852954|NCT00045942|Secondary|Summary of Midostaurin Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, was considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
2852919|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Clinician Version of The Clinical Global Impressions Improvement (CGI-I) Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||percent of participants|||Number
2852920|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Global Daily Activity Score|The OHDAS global daily activity score was calculated as the average of all daily activity item scores. The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH) to activities that required standing for a short time, standing for a long time, walking for a short time, walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
2852921|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores|The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH). Item 1 addressed activities that required standing for a short time; Item 2, activities that required standing for a long time; Item 3, activities that required walking for a short time; and Item 4, activities that required walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
2852922|NCT00046475|Secondary|Change From Baseline in The OHSA Composite Symptom Score|The OHSA composite symptom score was calculated by taking the average of the ratings for the symptoms present at Baseline. Participants were asked to rate symptoms by using a 0-10 scale (0 meaning not bothered and 10 meaning the worst). For subsequent visits, only those symptoms present at Baseline were scored. In this manner, a score was produced that represents the severity (and subsequent change in severity) of the patient's neurogenic OH symptoms, regardless of how many symptoms are presented at Baseline. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
2852923|NCT00046475|Secondary|Change From Baseline in The OHSA Items 2 Through 6 Scores|Items 2 through 6 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of the following symptoms whenever he or she was standing and that improved when he or she sat down or laid down: Item 2 addresses problems with vision (blurring, seeing spots, tunnel vision, etc); Item 3, weakness; Item 4, fatigue; Item 5, trouble concentrating; and Item 6, head or neck discomfort. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
2852924|NCT00046475|Primary|Re-analysis of The Post-treatment Score For Item 1 of The OHSA Scale, Excluding Two Sites|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement. Data for 2 sites were excluded from this re-analysis.|||scores on a scale||Standard Deviation|Mean
2852925|NCT00046475|Primary|Post-treatment Score For Item 1 of The Orthostatic Hypotension Symptom Assessment (OHSA) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.|||scores on a scale||Standard Deviation|Mean
2852926|NCT00046566|Secondary|Body Weight at 8 Weeks|Body weight was measured by trained staff using a standard protocol at week 8.|Every 8 weeks|Participants took supplementation for 8 weeks|||kg||95% Confidence Interval|Mean
2852927|NCT00046566|Secondary|Change From Baseline in Serum LDL-cholesterol at 8 Weeks|Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method.|Every 8 weeks|Participants took soy protein for 8 weeks|||mg/dL||95% Confidence Interval|Mean
2852928|NCT00046566|Primary|Change From Baseline in Average Systolic Blood Pressure at 8 Weeks|The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from two baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.|Every 8 weeks|participants took soy protein during three phases|||mmHg||95% Confidence Interval|Mean
2852929|NCT00046228|Other Pre-specified|Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7|Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.|Discharge/Day 7|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.|||participants|||Number
2852930|NCT00046228|Other Pre-specified|Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7||Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participants|||Number
2852931|NCT00046228|Other Pre-specified|Subjects With Severe Thrombocytopenia Through Discharge/Day 7|Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participants|||Number
2852932|NCT00046228|Other Pre-specified|Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7|Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participant|||Number
2852933|NCT00046228|Other Pre-specified|Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7|All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.|||participants|||Number
2852934|NCT00046228|Secondary|All-Cause Mortality Through 1 Year|All-cause mortality through 1 year from randomization.|1 year|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.|||participants|||Number
2852935|NCT00046228|Secondary|Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization||60 to 90 minutes|Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.|||participants|||Number
2852936|NCT00046228|Secondary|All-Cause Mortality Through 90 Days|All cause mortality occurred through 90 days from randomization.|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.|||participants|||Number
2852937|NCT00046228|Secondary|Complications of MI as Defined in the Primary Outcome Measure Through 90 Days|The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.|90 Days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.|||participants|||Number
2852938|NCT00046228|Primary|The Composite of All-Cause Mortality or Complications of MI at 90 Days.|Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.|||participants|||Number
2852939|NCT00045942|Secondary|Overall Survival (E2)|OS was measured from the date of the first dose of treatment to the date of death from any cause or the last date the patient was known to be alive (censored observation)|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..|||days||95% Confidence Interval|Median
2852940|NCT00045942|Secondary|Time to Disease Progression (E2)|TTP was defined as the time from the first dose date to the date of disease progression, which was defined as the study completion date for unsatisfactory treatment effect, the date of response assessment of progressive disease, or the date of death from any cause|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..|||days||95% Confidence Interval|Median
2852941|NCT00045942|Secondary|Best Clinical Response (E2)|Best clinical response was defined as CR, PR, MR, MR+BR, or BR . CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.|date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008|The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..|||Participants|||Number
2852955|NCT00045942|Secondary|Time to Disease Progression (TTP) (Core)|TTP was defined as the time from first dose date to date of disease progression which is identified as study completion date for unsatisfactory treatment effect or date of death from any cause within the 28 day cutoff post treatment.|from date of FPFV, 29-Jan-2002, to date of LPLV, 04-Sep-2003|Core primary efficacy population: The core primary efficacy population included all participants who were randomized.|||days||95% Confidence Interval|Median
2852942|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
2852943|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
2852944|NCT00045942|Secondary|Summary of PKC412 Plasma Concentration for 100 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)|The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
2852945|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration for 50 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
2852946|NCT00045942|Secondary|Summary of CGP62221 Plasma Concentration for 50 mg Bid Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
2852947|NCT00045942|Secondary|Summary of PKC412 Plasma Concentration for 50 mg Twice Daily (Bid) Arm (E1)|Blood samples were collected for analysis.|Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)|The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..|||ng/ml||Standard Deviation|Mean
2852948|NCT00045942|Secondary|Event-free Survival (E1)|Event-free survival was defined as the time from date of start of treatment to the date of death from any cause, treatment failure or relapse|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
2852949|NCT00045942|Secondary|Duration of Best Clinical Response (E1)|Duration of best clinical response was measured from the time that the measurement criteria were met for CR, PR, MR (with or without blast reduction) or BR until the first date that recurrent disease was documented (event) or until the date of last follow up.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Responders from the PEP; PEP defined as all patients who received at least 1 dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
2852950|NCT00045942|Secondary|Overall Survival (OS) (E1)|OS was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive (a censored observation).|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
2852951|NCT00045942|Secondary|Time to Disease Progression (E1)|TTP was defined as the time from the first dose date to the date of disease progression (defined as the study completion date for unsatisfactory treatment effect, date of response assessment of progressive disease, or date of death from any cause). One participant from the wild type 200 mg group did not have any assessment on treatment and therefore was not taken into account for TTP.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||days||95% Confidence Interval|Median
2852952|NCT00045942|Secondary|Summary of CGP52421 Plasma Concentration (Core)|Blood samples were collected for analysis.|Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,|The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
2853284|NCT00029172|Primary|Twelve Week Depression Outcomes|"Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%.~The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale."|Twelve week||||HAM-D depression score||Standard Deviation|Mean
2852956|NCT00045942|Primary|Summary of CGP52421 Concentration (E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Full Range|Median
2852957|NCT00045942|Primary|Summary of CGP62221 Concentration (E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Full Range|Median
2852958|NCT00045942|Primary|Summary of Midostaurin Concentration in the PKC412 Dose Escalation Arms(E2)|Blood samples were collected for analysis.|Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15|The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Full Range|Median
2852959|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
2852960|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Full Range|Median
2852961|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP52421 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
2852962|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP52421 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
2852963|NCT00045942|Primary|Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: day 22,|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For this end point, 4 participants with non-missing values were analyzed.|||hour||Standard Deviation|Mean
2852964|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP622221 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
2852965|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Full Range|Median
2852966|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
2852967|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP62221 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
2852968|NCT00045942|Primary|Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21 and 22|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Standard Deviation|Mean
2852969|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
2852970|NCT00045942|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)|Blood samples were collected for PK analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||hour||Full Range|Median
2852971|NCT00045942|Primary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||ng/ml||Standard Deviation|Mean
2852972|NCT00045942|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for PKC412 Plasma in the PKC + Itraconazole Combination Arm (E2)|Blood samples were collected for pharmacokinetic (PK) analysis.|Cycle 1: days 21, 22, 28|The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.|||h*ng/ml||Standard Deviation|Mean
2852973|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (E2)||Days 1, 28|The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.||||||
2852974|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (E1)||days 1, 28|The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.||||||
2852975|NCT00045942|Primary|Number of Participants With Overall Clinical Response (E1)|Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.|from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004|E1 primary efficacy population: all participants who received at least one dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.|||Participants|||Number
2852976|NCT00045942|Primary|Percent Decrease in Phospho-FLT3 Compared to Baseline (Core)||days 1, 28|This outcome measure was not analyzed. Assessment of FLT3 autophosphorylation in leukemic blasts was not possible at the planned time points because the blast reduction was rapid and occurred during the first week in some participants. Thus, by Day 28, the blast count in some participants were too low for autophosphorylation to be measured.||||||
2852977|NCT00045942|Primary|Number of Participants With Best Clinical Response (Core)|Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS.|from date of first patient first visit (FPFV), 29-Jan-2002, to date of last participant last visit (LPLV), 04-Sep-2003|Core primary efficacy population: The core primary efficacy population included all participants who were randomized.|||Participants|||Number
2852978|NCT00044655|Secondary|Psychiatric Symptoms, Hospitalization, and Medication Side Effects||Measured at Year 1|||||||
2852979|NCT00044655|Primary|Number Who Discontinued Medication Within First 6 Study Months||Measured at Six Months|intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy|||participants|||Number
2852980|NCT00044512|Secondary|Overall Survival|Time from the first date of receiving study medication to death.|Start of treatment to death|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
2852981|NCT00044512|Secondary|Duration of Minor Response|Time from the date that MR was first documented to the date that PD was first documented.|Time from MR to PD|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||Full Range|Mean
2852982|NCT00044512|Secondary|Time to Minor Response|Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
2852983|NCT00044512|Secondary|Duration of Stable Disease|Time from the first day of receiving study drug until there was a documented PD or response.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
2852984|NCT00044512|Secondary|Time to Progression|Time from the first date of receiving study drug until the first documented PD.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).|||days||95% Confidence Interval|Median
2852986|NCT00044512|Secondary|Duration of Response|Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and C status (positive vs negative). The 3 subjects are censored at time of evaluation. The Median is not estimable so the reported number is biased.|||days||Full Range|Median
2852987|NCT00044512|Primary|Percentage of Participants for Each Type of Response|Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.|Until 30 days after termination of active therapy|Intention to Treat (ITT) analyses were performed on subgroups of patients categorized by baseline characteristics of ECOG Performance Status, Child Pugh status, TNM stage at study entry, prior surgical procedure, hepatitis A and B status, and age.|||percentage of participants|||Number
2852988|NCT00044213|Secondary|A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.|Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median||||participants|||Number
2852989|NCT00044213|Primary|A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.|Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median||||participants|||Number
2852990|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on scale||Standard Error|Least Squares Mean
2852991|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on a scale||Standard Error|Least Squares Mean
2852992|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on a scale||Standard Error|Least Squares Mean
2852993|NCT00044044|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score|"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia."|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.|||units on a scale||Standard Error|Least Squares Mean
2852994|NCT00044005|Primary|Number of Participants With Adverse Events|The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.|6-months|No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.|||participants|||Number
2852995|NCT00044083|Secondary|Positive and Negative Syndrome Scale|Rating Scales PANSS. The Positive Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The Negative Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The General Scale ranges from 16 to 112, the higher score indicating greater severity of symptoms.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|There were 74 Healthy Volunteers and 33 Patients with Schizophrenia|||units on a scale||Standard Deviation|Mean
2852996|NCT00044083|Primary|N-Back Task Activation by Genotype in Patients With Schizophrenia|Activation beta values (N-Back vs. 0-Back) extracted from DLPFC from the contrast maps in Patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|33 patients with schizophrenia|||beta value||Standard Error|Mean
2852997|NCT00044083|Primary|N-Back Task Activation Genotype Effect in Healthy Volunteers|Activation beta values (N-Back vs. 0-Back) extracted within the Effect of Genotype cluster around the peak (p < 0.05 uncorrected) in right and left DLPFC from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)||||beta value||Standard Error|Mean
2852998|NCT00044083|Primary|N-Back Task Activation in Healthy Volunteers|Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|74 Healthy Volunteers|||beta value||Standard Error|Mean
2852999|NCT00044083|Primary|N-Back Task Activation in DLPFC in Patients With Schizophrenia|Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|33 Patients with Schizophrenia|||beta value||Standard Error|Mean
2853000|NCT00044083|Primary|N-Back Task Activation Drug Effect|Activation beta values (N-Back vs. 0-Back) extracted within the Main Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps across both groups. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|74 Healthy Volunteers and 33 Patients with Schizophrenia|||beta value||Standard Error|Mean
2853001|NCT00044083|Primary|N-Back Task Activation Diagnosis Effect|Activation beta values (N-Back vs. 0-Back) were extracted within the Main Effect of Diagnosis cluster around the peak (p < 0.05 uncorrected) from the contrast maps in the Placebo condition. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|74 Healthy Volunteers and 33 Patients with Schizophrenia|||beta value||Standard Error|Mean
2853002|NCT00044083|Primary|N-Back Task Performance|Working Memory was measured in HVs and patients with schizophrenia after a 7-day treatment with Tolcapone or placebo in a double-blind, cross-over fashion. The working memory was quantified by taking the number of trials entered correctly divided by the total number of trials multiplied by 100. Values range from 0 to 100. Zero indicates the poorest performance while 100 indicates perfect performance.|At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)|147 HV’s recruited, 8 left after signing consents, 8 excluded for other reasons, 57 excluded for excessive motion, inferior quality or not completion. 63 patients recruited, 4 removed for different reasons, 26 excluded from image analyses for not completing the second phase of the study, excessive motion or bad image quality.|||% of Correct Trials||Standard Error|Mean
2853003|NCT00043979|Other Pre-specified|Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy|Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria.|up to 6 cycles or 168 days|G1, grade 1; G2, grade 2; G3, grade 3; G4, grade 4; G5, grade 5. 23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Participants|||Count of Participants
2853004|NCT00043979|Other Pre-specified|Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)|GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy.|up to day 100|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Participants|||Count of Participants
2853005|NCT00043979|Secondary|Median Survival From Date of Progression|Median survival from date of progression is based on the time from on-study date until progression or last follow-up.|up to 77 months|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Months||Full Range|Median
2853006|NCT00043979|Secondary|Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed.|up to 10 cycles of therapy or 280 days|EPOCH-F (Etoposide, Vincristine, Prednisone, Cyclophosphamide, Doxorubicin, and Fludarabine) was modified to EOCH and administered to 12 patients for post-transplantation disease progression.|||Participants|||Count of Participants
2853007|NCT00043979|Secondary|Cluster of Differentiation 4 (CD4) Reconstitution|The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing.|Day +28-42||||mm(3)||Full Range|Median
2853008|NCT00043979|Secondary|Number of Participants to Complete Conversion to >95% Donor Chimerism|Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue.|up to 30 days|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Participants|||Count of Participants
2853009|NCT00043979|Secondary|Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant|Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant.|2 years|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||percentage of participants|||Number
2853010|NCT00043979|Secondary|Median Progression Free Survival|Progression free survival was based on the time from on-study date until progression or last follow-up.|up to 77 months|23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling.|||Months||Full Range|Median
2853016|NCT00043979|Primary|Number of Participants With Engraftment|Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients.|100 days|"E.g ...in >75% of patients, shown above is not a conclusion but refers to a hypothesis, the objective of the protocol.~23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling."|||Participants|||Number
2853017|NCT00043550|Primary|Hamilton Rating Scale for Depression-17 Item|Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin & Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.|symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16|Numbers vary from consented due to dropout prior to start of study. 156 patients consented and randomized. 11 patients did not complete at least one post-randomization measure and were therefore not included in these analyses.|||units on a scale||Standard Deviation|Mean
2853018|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Inter-Quartile Range|Median
2853019|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Inter-Quartile Range|Median
2853020|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Inter-Quartile Range|Median
2853021|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Inter-Quartile Range|Median
2853022|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Inter-Quartile Range|Median
2853023|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
2853024|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
2853025|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
2853026|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
2853027|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
2853028|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
2853029|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
2853030|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
2853285|NCT00029146|Other Pre-specified|Any Stroke or Death Within 30 Days After Surgery||within 30 days after surgery|Intention-to-treat. All assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy|||participants|||Number
2853034|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
2853035|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
2853036|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
2853037|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
2853038|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 48|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Inter-Quartile Range|Median
2853039|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 42|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Inter-Quartile Range|Median
2853040|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 36|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Inter-Quartile Range|Median
2853041|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 24|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Inter-Quartile Range|Median
2853042|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 48|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Inter-Quartile Range|Median
2853043|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 42|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participantswith non-missing Baseline and non-missing value at Month 42.|||Percent change||Inter-Quartile Range|Median
2853044|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 36|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Inter-Quartile Range|Median
2853045|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 24|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Inter-Quartile Range|Median
2853046|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.|||Percent change||Standard Error|Least Squares Mean
2853047|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.|||Percent change||Standard Error|Least Squares Mean
2853048|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.|||Percent change||Standard Error|Least Squares Mean
2853049|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.|||Percent change||Standard Error|Least Squares Mean
2853050|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
2853053|NCT00043186|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.|||Percent change||Standard Error|Least Squares Mean
2853054|NCT00042432|Secondary|Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase|Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase|Baseline, efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation|||Percent change||Standard Error|Mean
2853055|NCT00042432|Primary|Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase|Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase|Efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation|||Participants|||Number
2853056|NCT00042224|Primary|Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.|Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined (ranges 4 -28, with higher scores indicative of greater severity). A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.|8 Weeks|inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.|||Percentage of responders|||Number
2853057|NCT00041938|Other Pre-specified|Rate Per 100 Patient-years of Minor Hemorrhage.|Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization until the end of scheduled follow-up, up to 6 years|Intent-to-treat|||events per 100 patient-years|||Number
2853058|NCT00041938|Other Pre-specified|Rate Per 100 Patient Years of Major Hemorrhage|Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until end of scheduled follow-up, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
2853059|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome|Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of secondary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
2853060|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
2853061|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome|Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years|Intent-to-treat.|||events per 100 patient years|||Number
2853062|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.|Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years|Intent-to-treat.|||events per 100 patient years|||Number
2853111|NCT00038948|Secondary|First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.|Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).|52 and 104 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.|||patients|||Number
2853063|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient years|||Number
2853064|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Death|Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of primary composite outcome, up to 6 years|Intent-to-treat|||events per 100 patient-years|||Number
2853065|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Intracerebral Hemorrhage|Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years|Intent-to-treat|||rate per 100 patient years|||Number
2853066|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Ischemic Stroke|Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years|Intent-to-treat|||rate per 100 patient years|||Number
2853067|NCT00041938|Secondary|Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.|"The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.~Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25."|From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.|Intent-to-treat analysis: all enrolled patients were analyzed.|||events per 100 patient-years|||Number
2853068|NCT00041938|Primary|Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death|The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years|Intent-to-treat analysis: all enrolled patients were analyzed.|||events per 100 patient-years|||Number
2853069|NCT00041756|Primary|Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year|The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)|baseline and 12 months|An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2853070|NCT00041756|Primary|Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment|The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.|baseline and 12 months|"An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.~analysis."|||mm||Standard Error|Least Squares Mean
2853071|NCT00041717|Primary|Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment|This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|ITT|||units on a scale||Standard Error|Mean
2853072|NCT00041717|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|Intent to treat (ITT) population|||units on a scale||Standard Error|Mean
2853073|NCT00041470|Secondary|To Measure the Qualitative and Quantitative Toxicity of This Regimen.||<=18 months||||Participants|||Count of Participants
2853074|NCT00041470|Primary|To Measure Response Rates, Time to Progression and Survival in Patients so Treated.||1 year||||Participants|||Count of Participants
2853075|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Ctau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||microgram per milliliter||95% Confidence Interval|Least Squares Mean
2853076|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Cmax|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||micrograms/milliliters||95% Confidence Interval|Least Squares Mean
2853077|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: AUC0-tau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours*micrograms/milliliters||95% Confidence Interval|Least Squares Mean
2853078|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: t1/2|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours||95% Confidence Interval|Geometric Mean
2853079|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||milliliters/minute||95% Confidence Interval|Geometric Mean
2853080|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||milliliters/minute/kilogram||95% Confidence Interval|Geometric Mean
2853081|NCT00040664|Primary|Median Steady State Plasma APV Tmax|tmax: time after administration of the drug when maximum concentration is reached|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours||Full Range|Median
2853082|NCT00040664|Secondary|Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. Virologic failure is defined as HIV-1 RNA greater than or equal to 400 copies/mL.|Time of virologic failure|Participants in the ITT-E Population who met the virologic failure definition. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.|||Participants|||Number
2853083|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: Cmax|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||micrograms/milliliter||95% Confidence Interval|Geometric Mean
2853381|NCT00023595|Secondary|H01: All-cause Mortality, Heart Transplant or LVAD|LVAD=Left Ventricular Assist Device|5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853084|NCT00040664|Primary|Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.|||hours*micrograms/milliliter||95% Confidence Interval|Geometric Mean
2853085|NCT00040664|Primary|Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities|The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug|||Participants|||Number
2853086|NCT00040664|Primary|Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event|The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug|||Participants|||Number
2853087|NCT00040664|Secondary|Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.|||Cells/mm3||Inter-Quartile Range|Median
2853088|NCT00040664|Secondary|Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 12, 24, 48, 96, and 168. Change from Baseline was defined as the HIV-1 RNA level at Weeks 12, 24, 48, 96, and 168 minus the HIV-1 RNA level at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.|||log10 copies/mL||Inter-Quartile Range|Median
2853089|NCT00040664|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.|Weeks 12, 48, 96, and 168|The Intent-to-Treat Exposed (ITT [E]) Population consisted of all subjects with documented evidence of having received at least one dose of study drug. Results are stratified by previous protease inhibitor (PI) experience. Participants with previous PI experience may respond differently to FPV.|||percentage of participants|||Number
2853090|NCT00040664|Primary|Number of Participants Who Discontinued Treatment Due to Adverse Events|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug|||Participants|||Number
2853091|NCT00041392|Primary|Cognitive Function|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.|Measured at baseline and 6 weeks||||Continuous cognitive change score||Standard Deviation|Mean
2853092|NCT00040443|Primary|15-Item Word List Delayed Recall|"The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI.~The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled."|28 Days|Intent to Treat (ITT)|||units on a scale - change from baseline||Standard Deviation|Mean
2853093|NCT00040365|Secondary|Number of Participants Who Had Proctoscopic Examinations|Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis.|3 years||||Participants|||Number
2853094|NCT00040365|Secondary|Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)|Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined.|Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18||||scores on a scale||Full Range|Mean
2853314|NCT00023595|Secondary|H02: General Health Rating Scale|This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853095|NCT00040365|Secondary|Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)|The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf|18 months||||scores on a scale||Standard Deviation|Mean
2853096|NCT00040365|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 years||||Participants|||Number
2853097|NCT00040365|Secondary|Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx.|The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.||||Percentage of Participants|||Number
2853098|NCT00040365|Primary|Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx|RTOG Acute was used on week 5 and 7|Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period.|||Percentage of Participants|||Number
2853099|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12|Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants with detectable but >=2 log drop in HCV-RNA at Treatment Week 12|||Participants|||Number
2853100|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12|Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants who had undetectable HCV-RNA at Treatment Week 12|||Participants|||Number
2853101|NCT00039871|Primary|Sustained Virologic Response (SVR) Rate|Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)|Assessed at end of 24 weeks posttreatment follow-up|Participants who received at least one dose of study medication|||Participants|||Number
2853102|NCT00039741|Secondary|Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks||24 weeks|Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24.|||participants|||Number
2853103|NCT00039741|Secondary|Change in CD4% From Randomization to 4 Years||Randomization to 4 years|Intent to treat, for participants who had CD4% values available at 4 years and at baseline.|||CD4 percent (% of total lymphocytes)||Standard Deviation|Mean
2853104|NCT00039741|Secondary|Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204||Week 204|Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204.|||participants|||Number
2853105|NCT00039741|Secondary|Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy|25th Percentiles in weeks from randomization to HIV-1 RNA of 30,000 copies/ml or greater during second-line therapy or permanent discontinuation of second-line therapy|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||Weeks (25th Percentile)|||Number
2853106|NCT00039741|Secondary|Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy|25th Percentiles in weeks from randomization HIV-1 RNA of 400 copies/ml or greater during first-line therapy or permanent discontinuation of first-line therapy.|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||Weeks (25th Percentile)|||Number
2853107|NCT00039741|Secondary|Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)|25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen)|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||Weeks (25th Percentile)||Inter-Quartile Range|Median
2853108|NCT00039741|Secondary|Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death||Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||participants|||Number
2853109|NCT00039741|Secondary|Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced|"Adverse events were graded according to the following guidelines:~PACTG: The Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) dated May 6, 2004.~PENTA: International Conference for Harmonization (ICH) requirements and the EU Clinical Trials Directive 2001/20/EC (20).~A rating of Grade 3 is severe and Grade 4 is life-threatening. The rate of serious (Grade 3 or above)events is reported as the number of events per 100 child/years."|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat|||events/100 child-years||95% Confidence Interval|Mean
2853110|NCT00039741|Primary|Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml||Baseline visit and 4 years after Study Entry|Intent-to-treat analyses for those subjects who had data at baseline and 4 years. Analyses were done by collapsing groups to examine drug class (regardless of switch point) and switch point (regardless of drug class).|||log10 HIV-1 RNA||Standard Error|Mean
2853115|NCT00038727|Secondary|Short Physical Performance Battery|Physical function is measured using the short physical performance battery (SPPB), which is comprised of measures of 1) time to walk 3-4 meters, 2) balance, i.e., side-by-side stand, semi-tandem stand, and tandem stand, and 3) repeated chair stands.|Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.||2021-07-31|07/2021||||
2853116|NCT00038727|Secondary|Cognitive Function|Cognitive function defined as a composite measure constructed from tests of memory (English Spanish Verbal Learning Test) and executive function (word fluency and Digit Symbol Substitution Test ).|Outcomes were assessed in visit years starting in 2010, 2012, 2017, 2020.||2021-07-31|07/2021||||
2853117|NCT00038727|Secondary|Subclinical Atherosclerosis|Measured using coronary artery calcification (CAC).|Outcomes were assessed from 2012-2013 (approximately 2 years).|DPPOS Participants who met eligibility criteria and consented to have CAC measurements - by sex|||CAC geometric mean in AU||95% Confidence Interval|Geometric Mean
2853118|NCT00038727|Primary|Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD)|Defined as MI, stroke and CVD death. These outcomes were collected since randomization and adjudicated by an outcomes committee who are blinded to treatment assignment.|Outcomes were assessed from 1996-2025 (approximately 29 years).||2025-06-30|06/2025||||
2853119|NCT00038727|Primary|Total Cancer Except Non-melanoma Skin Cancer|All primary incident cancers except non-melanoma skin cancer|Outcomes were assessed from 1996-2020 (approximately 24 years).||2020-12-31|12/2020||||
2853120|NCT00038727|Primary|Prevalence of Aggregate Microvascular Complication|Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed).|Outcomes were assessed from 2012-2013 (approximately 2 years).|Number with microvascular outcome data and included in the primary outcome analysis|||average percentage of participants||95% Confidence Interval|Number
2853121|NCT00038727|Primary|Development of Diabetes.|Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test).|Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).||||diabetes incidence (cases per 100 person||95% Confidence Interval|Number
2853122|NCT00038649|Secondary|Participant Complete Hematologic Remission (CHR) Classified|Number of participants with Complete Hematologic Remission (CHR): normalization >4 weeks of bone marrow (<5% blasts), peripheral blood with WBC <10 x 109/L & no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. CHR further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or i Fluorescence In Situ Hybridization (FISH): No cytogenetic response - Ph positive 100% of pretreatment value; Minor cytogenetic response - Ph positive 35-90% of pretreatment value; Partial cytogenetic response - Ph positive 1-34% of pretreatment value; Complete cytogenetic response - Ph positive 0%. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.|Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.|Analysis was of the 110 participants who achieved a CHR with a cytogenetic response as described in the outcome measure descriptions.|||participants|||Number
2853123|NCT00038649|Primary|Number of Participants With Molecular Response of Complete or Partial Hematologic Remission|Complete Hematologic Remission (CHR): normalization >4 weeks of bone marrow (<5% blasts), peripheral blood with White Blood Cells (WBC) <10 x 109/L & no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly < 50% of pretreatment, or thrombocytosis >450x109/L but <50% of pretreatment. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.|Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.||||participants|||Number
2853124|NCT00038610|Primary|Disease-Free Survival Rate at 2-year and 5-year.|Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.|Baseline to 2-year and 5-year||||percentage of participants|||Number
2853125|NCT00038610|Secondary|Overall Survival Rate at 2-year and 5-year.|Overall survival (OS) was calculated from the date of initiation of therapy until death.|Baseline to 2-year and 5-year||||percentage of participants|||Number
2853126|NCT00038610|Primary|Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate|"Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.~Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.~Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease."|Baseline to 6 months|Of the 54 participants, 39 (72%) presented with de novo disease, 6 (11%) were refractory to standard induction therapy, and 9 (17%) entered the study in complete remission (CR) after one course of standard induction therapy.|||participants|||Number
2853127|NCT00038467|Secondary|Number of Participants With Histological Findings: Endometrial Sub-study||Baseline up to 24 months post-treatment|Results were not reported for this outcome measure because no data was collected as per change in planned analysis.||||||
2853128|NCT00038467|Secondary|Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study|Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.|Baseline up to 24 months post-treatment|As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.|||percentage of participants|||Number
2853159|NCT00038103|Secondary|Duration of Long-Term SD|Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV|Evaluable population. Number of participants analyzed = number of subjects with long-term SD.|||weeks||95% Confidence Interval|Median
2853129|NCT00038467|Secondary|Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study|Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively.|||participants|||Number
2853130|NCT00038467|Secondary|Uterine and Overall Ovary Volume: Endometrial Sub-study|Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.|||cubic centimeter (cm^3)||Full Range|Median
2853131|NCT00038467|Secondary|Endometrial Thickness: Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.|||mm||Full Range|Median
2853132|NCT00038467|Secondary|Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.|||percentage of participants|||Number
2853133|NCT00038467|Secondary|Number of Participants With Severe Endocrine Symptoms: QoL Sub-study|"Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories quite a bit and very much) were presented."|Baseline up to 24 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||participants|||Number
2853134|NCT00038467|Secondary|Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853135|NCT00038467|Secondary|Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853315|NCT00023595|Secondary|H01: General Health Rating Scale|"This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853136|NCT00038467|Secondary|Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853137|NCT00038467|Secondary|Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy|The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853138|NCT00038467|Secondary|Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853139|NCT00038467|Secondary|Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853140|NCT00038467|Secondary|Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853147|NCT00038467|Secondary|Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
2853141|NCT00038467|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|||units on a scale||Standard Deviation|Mean
2853142|NCT00038467|Secondary|Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not.|||units on a scale||Standard Deviation|Mean
2853143|NCT00038467|Secondary|Number of Participants With Fracture: Bone Metabolism Sub-study||Baseline up to 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.|||participants|||Number
2853144|NCT00038467|Secondary|Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
2853145|NCT00038467|Secondary|Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
2853146|NCT00038467|Secondary|Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
2853157|NCT00038103|Secondary|Time to Treatment Failure|Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population|||Weeks||95% Confidence Interval|Median
2853158|NCT00038103|Secondary|Time to Tumor Progression|Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV|Evaluable population|||weeks||95% Confidence Interval|Median
2853148|NCT00038467|Secondary|Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.|||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
2853149|NCT00038467|Secondary|Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.|||T-score||Standard Deviation|Mean
2853150|NCT00038467|Secondary|Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.|||percent change||Standard Deviation|Mean
2853151|NCT00038467|Secondary|Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.|||percent change||Standard Deviation|Mean
2853152|NCT00038467|Secondary|Number of Events of Second Breast Cancer in Contralateral Breast: Main Study|Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.|||events|||Number
2853153|NCT00038467|Secondary|Overall Survival (OS) at Month 36 Post-Randomization: Main Study|OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.|||probability of OS||95% Confidence Interval|Number
2853154|NCT00038467|Primary|Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study|DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.|Baseline up to Month 36|Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.|||probability of DFS||95% Confidence Interval|Number
2853155|NCT00038142|Primary|2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer|DFS defined as survival of participants to two years post study entry without relapse.|2 years|Data was not collected due to early termination of the protocol||||||
2853156|NCT00038103|Secondary|Survival|Time from randomization to date of death (any cause).|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death|Evaluable population|||weeks||95% Confidence Interval|Median
2853160|NCT00038103|Secondary|Duration of Objective Response (in Subjects With CR or PR)|Time from the first objective documentation of response until the first objective documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with objective response.|||weeks||95% Confidence Interval|Median
2853161|NCT00038103|Secondary|Duration of Clinical Benefit|Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.|||weeks||95% Confidence Interval|Median
2853162|NCT00038103|Secondary|Number of Subjects With Objective Response|Objective tumor response includes subjects with CR or PR according to RECIST.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population|||participants|||Number
2853163|NCT00038103|Primary|Number of Subjects With Clinical Benefit|Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.|Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)|Evaluable population|||participants|||Number
2853164|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 96|Number of subjects enrolled at this time point.|||Scores on scale||Standard Error|Mean
2853165|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 72|Number of subjects enrolled at this time point.|||Scores on a scale||Standard Error|Mean
2853166|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 48||||Scores on a scale||Standard Error|Mean
2853167|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24||||Scores on a scale||Standard Error|Mean
2853168|NCT00037830|Secondary|Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
2853169|NCT00037830|Secondary|Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
2853170|NCT00037830|Post-Hoc|Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication||Week 36 to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Mean
2853240|NCT00035555|Secondary|Percentage of Participants Who Had Chronic Allograft Nephropathy|Based on postbaseline biopsies|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation and who had at least 1 biopsy following Day 1; n=evaluable participants|||Percentage of participants|||Number
2853171|NCT00037830|Post-Hoc|Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication|Unified Parkinson's Disease Rating Scale (UPDRS) A four part scale used to assess the severity of Parkinson's disease symptoms. Part I contains questions concerning the patient's mentation, behavior and mood. Part II asks questions about the patient's ability to perform activities of daily living. Part III is the motor examination of the patient's symptoms ranging in scores from 0 to 4 with 0 equaling either normal or absence of symptoms. The minimum score on this section is 0 and the maximum is 108. Part IV asks the patient questions about any complications of therapy they have experienced within the past week. However, for this study the total UPDRS included Parts I, II, and III. A higher the score on the scale indicates more severe symptoms.|Week 6 to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Mean
2853172|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
2853173|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.|||Scores on a scale||Standard Error|Least Squares Mean
2853174|NCT00036569|Secondary|Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques|MRI of the brain will be performed at the NCI prior to cycles 1, 2, 3, 5, 7, and continuing every other month until cycle 27. Following cycle 27 the patient will have an MRI performed every third cycle until cycle 52 at which time they will have an MRI performed annually, and when clinically indicated. Baseline MR images are compared with MR images performed during the various cycles (e.g. cycles 1, 2, 3...) Imaging was exploratory and the degree of change that is considered clinically significant rather than technique related is still being explored.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.||||Participants|||Number
2853175|NCT00036569|Secondary|Mean Quality of Life (QOL) Score at Baseline and Follow-Up|QOL questionnaires will be performed prior to every cycle for patients age 6-18 years and their parents until cycle 27 and then prior to every third cycle until cycle 52 when the evaluations will become annual. The QOL (NIH Impact of Pediatric Illness Scale) is too detailed to be described and/or shown here. It is a questionnaire made up of approximately 40 questions-the answers are ranked from 1 to 5 with 5 being no impact and 1 being significant impact-For further details see the protocol.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.||||Units on a scale||Standard Error|Mean
2853176|NCT00036569|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 yrs 11 mo 22 days||||Participants|||Number
2853177|NCT00036569|Secondary|Median Time to Progression|Time between the final day of treatment to the day of disease progression.|8 yrs 11 mo 22 days||||Days|||Number
2853178|NCT00036569|Primary|Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas|Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.|8 yrs 6 mo 0 days||||Percentage of patients|||Number
2853179|NCT00036270|Secondary|Number of Participants With New Primary Non-breast Cancers|Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Participants|||Number
2853180|NCT00036270|Secondary|Number of Events for Time to Relapse|Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Events (disease relapse)|||Number
2853181|NCT00036270|Secondary|Time to New Primary Breast Cancers|New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).|Baseline (Month 0) up to 5 years|Data was not analyzed due to insufficient number of events reported for the endpoint.||||||
2853182|NCT00036270|Secondary|Number of Events for Overall Survival (OS)|Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Events (death)|||Number
2853183|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 5 years|ITT population included all participants who were randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.|||Events (disease relapse or death)|||Number
2853184|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 2.75 years|Intent-to-Treat (ITT) population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at 2.75 years.|||Events (disease relapse or death)|||Number
2853185|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||log10 c/mL||Standard Error|Mean
2853186|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 24|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
2853187|NCT00035932|Secondary|Inhibitory Quotient at Week 48|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||ratio||Standard Error|Mean
2853188|NCT00035932|Secondary|Inhibitory Quotient at Week 24|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 24|Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).|||ratio||Standard Error|Mean
2853189|NCT00035932|Secondary|HIV IC50 at Week 24|IC50: inhibitory concentration of drug required to reduce viral replication by 50%.|Week 24|Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).|||ng/mL||Standard Error|Mean
2853190|NCT00035932|Secondary|Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values|"The minimum or trough concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose."|collected at the pre-dose time point after receiving atazanavir for at least four weeks|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).|||ng/mL||Standard Error|Mean
2853191|NCT00035932|Secondary|Number of Participants Utilizing Resources for Managing Lipid Elevation|Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.|Baseline, Week 24, Week 48|Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.|||Participants|||Number
2853192|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 96||Baseline, Week 96|Randomized participants while on initial regimen|||log10 c/mL||Standard Error|Mean
2853193|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.|||units on a scale||Standard Error|Mean
2853194|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.|||units on a scale||Standard Error|Mean
2853195|NCT00035932|Secondary|Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Baseline, Week 24, Week 48|Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)|||participants|||Number
2853196|NCT00035932|Secondary|PR Interval and Change From Baseline by Analysis Time Point|The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint|||msec||Standard Error|Mean
2853197|NCT00035932|Secondary|Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint|||msec||Standard Error|Mean
2853198|NCT00035932|Secondary|Grade 3/4 Laboratory Abnormalities Through Week 48|Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4).|From Enrollment to Week 48|Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
2853199|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 48||Week 48|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).|||mg/dL||Standard Error|Mean
2853200|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 24||Baseline, Week 24|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).|||mg/dL||Standard Error|Mean
2853201|NCT00035932|Secondary|Most Common AEs and AEs of Interest Through Week 48|Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.|From Enrollment to Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
2853202|NCT00035932|Secondary|Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.|From Enrollment through Week 48|Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.|||participants|||Number
2853203|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 96, Observed Values|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 96|Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||percent change in lipid values|||Number
2853204|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 48|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 48|Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).|||percent change in lipid values|||Number
2853205|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 24|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Baseline, Week 24|Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).|||percent change|||Number
2853206|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||Pearson Correlation Coefficient|||Number
2853207|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.|Baseline, Week 24|Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).|||Pearson Correlation Coefficient|||Number
2853208|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.|||Pearson Correlation Coefficient|||Number
2853209|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.|Baseline, Week 24|Week 24: Participants with evaluable PK measurements|||Pearson Correlation Coefficient|||Number
2853210|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|Randomized participants (while on initial regimen) with evaluation at time point|||cells/mm3||Standard Error|Mean
2853211|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|Randomized participants while on initial regimen (completers censored).|||cells/mm3||Standard Error|Mean
2853212|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline, Week 24|Randomized participantsRandomized participants while on initial regimen (completers censored).|||cells/mm3||Standard Error|Mean
2853213|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored)|||participants|||Number
2853214|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participantsRandomized participants while on initial regimen (completers censored).|||participants|||Number
2853215|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
2853216|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored).|||participants|||Number
2853217|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
2853218|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants while on initial regimen Randomized participants, (completers censored).|||participants|||Number
2853219|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96||Week 96|Randomized participants while on initial regimen (completers censored).|||Participants|||Number
2853220|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.|||participants|||Number
2853221|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48||Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||Participants|||Number
2853222|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.|||participants|||Number
2853223|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24||Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||participants|||Number
2853224|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96.|Baseline, Week 96|Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.|||participants|||Number
2853225|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 48||Baseline, Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
2853226|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.|||participants|||Number
2853227|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.|||participants|||Number
2853228|NCT00035932|Secondary|Mean Change From Baseline in HIV RNA at Week 2||Baseline, Week 2|Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
2853229|NCT00035932|Primary|Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24||Baseline, Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).|||log10 c/mL||Standard Error|Mean
2853230|NCT00035815|Secondary|Rate of Change in ALS Functional Rating Scale.|The final secondary outcome measure was the rate of change in the ALS Functional Rating Scale (ALSFRS-r) score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). This is a scale from 0 to 48 assessing functional impairment in 12 clinically relevant areas in ALS. Forty-eight is normal with full function and zero is total loss of function in all clinical functions. As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.|Baseline and 24 months||||Units on a scale per month||Standard Deviation|Mean
2853231|NCT00035815|Secondary|Number of Participants Alive and Tracheostomy-free at 24 Months|Patients who elected to proceed to tracheostomy were assessed the month of their procedure. Subjects who continuously utilized non-invasive positive pressure ventilation for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous Non Invasive Positive Pressure Ventilation (NIPPV). All subjects were followed for the 24 month time period.|baseline to 24 months||||participants|||Number
2853232|NCT00035815|Primary|Rate of Change in Composite Manual Muscle Testing (MMT) Score|The primary outcome measure was the rate of change in the MMT score. MMT involved the examination of 34 muscle groups with standard positioning. The final MMT score represented an average of the 34 muscles examined, and ranged from 10 to 0(10 normal strength, 0 paralyzed). The individual muscle score was based on the medical research council (MRC) grading scale (1-5) modified to a 10 point system corresponding to the MRC modifications of plus and minus (5, 5-,4+,4,4-,3+,3, 3-,2,1,0; with 5 being normal strength and 0 paralyzed).|Baseline and 24 months||||MMT units per month||Standard Deviation|Mean
2853233|NCT00035555|Other Pre-specified|Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results|Normal laboratory values: Hemoglobin (g/dL): Males (18-64 years) 13.8-17, (65 years and older) 11.8-16.8; Females (18-64 years) 12.0-15.6, F (65 years and older) 11.1-15.5. Platelets (per mm^3) 130,000-400,000. Leukocytes (18 years and older) 3.8-10.8 1000/uL. ALT (u/L)(13 years and older) 0-48.|Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1)|All randomized participants who underwent transplantation and who received treatment|||Participants|||Number
2853234|NCT00035555|Secondary|Number of Participants With Posttransplant Diabetes Mellitus|Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of >4 weeks or hemoglobin A1c (HbA1c) >7% in a participant not known to be diabetic prior to transplantation|By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )|All randomized participants who received transplants and who were not known to be diabetic prior to transplant|||Participants|||Number
2853235|NCT00035555|Secondary|Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels|LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who received a transplant; n=evaluable participants.|||mg/dL||Standard Deviation|Mean
2853236|NCT00035555|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 (posttransplant) continuously to 56 days following last dose of study medication|All randomized participants who underwent transplantation and who received treatment|||Participants|||Number
2853237|NCT00035555|Secondary|Number of Participants With Hypertension|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Participants|||Number
2853238|NCT00035555|Secondary|Percentage of Participants Who Used Antihypertensive Medication|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
2853239|NCT00035555|Secondary|Mean Iohexol Clearance|Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who underwent transplantation|||mL/min per 1.73 m^2||Standard Deviation|Mean
2853241|NCT00035555|Secondary|Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)|Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
2853242|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).|By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
2853243|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.|Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation|||Percentage of participants|||Number
2853244|NCT00035555|Primary|Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)|No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.|By Month 6 posttransplant (From Day 1 to Month 6)|All randomized participants who underwent transplantation|||Participants|||Number
2853245|NCT00033917|Secondary|Language Outcome|"Peabody Picture Vocabulary Test (PPVT) This is a semantic language test. The mean value is 100; standard deviation is 16 points. A higher score means better language; a lower score means poorer language.~There are no subscales to the PPVT. The measurement unit is points on a scale. A score < 70 indicates severely abnormal language function."|at 8 years|Three hundred twenty eight subjects were available at age 8 years. They were tested with the PPVT.|||participants with PPVT score < 70|||Number
2853246|NCT00033917|Primary|IVH at 5 Postnatal Days|Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age|at 5 days|All subjects had negative cranial ultrasounds with no evidence for IVH at 6 - 12 postnatal hours|||IVH|||Number
2853247|NCT00032630|Primary|Long-term Composite|Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.|one-year||||Participants|||Number
2853248|NCT00032630|Primary|Short-term End Point|Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.|30 day||||participants|||Number
2853249|NCT00032591|Secondary|Health Care Costs at 2 Year||After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat|||U.S. Dollars||Standard Deviation|Mean
2853250|NCT00032591|Secondary|Cumulative Gain in Health Utilities at 2 Year|Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00.|After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat|||score||Standard Deviation|Mean
2853251|NCT00032591|Secondary|DASS at 2 Years of Follow-up|Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.|At two years of follow-up|Randomized participants with at least one day of follow-up, per intent to treat|||score||Standard Deviation|Mean
2853252|NCT00032591|Secondary|Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)|Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio|Full length of follow-up; average of 3 years|Randomized participants with at least one day of follow-up, per intent to treat|||percentage||Standard Deviation|Mean
2853253|NCT00032591|Primary|Time to First Event (Death, Stroke, Major Bleed)|"Time to first event (death, stroke, major bleed)~The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information."|Time to event|Randomized participants with at least one day of follow-up, per intent to treat|||cumulative probability of event||95% Confidence Interval|Number
2853254|NCT00032487|Secondary|Secondary Endpoint|New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.|Post baseline time to first event up to 82 months||||participants|||Number
2853255|NCT00032487|Primary|Primary Major Macrovascular Events|Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.|Post baseline time to the first major macrovascular event up to 82 months||||participants|||Number
2853376|NCT00023595|Secondary|H01: All-cause (Unplanned and Elective) Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853256|NCT00031551|Other Pre-specified|Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy|Participants selected from 14 word descriptors of sensory (S) pain and 11 word descriptors of affective (A) pain.|day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time|||percentage of participants|||Number
2853257|NCT00031551|Other Pre-specified|Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)|Subjects rated pain using the Painometer, a hand-held tool with a visual analogue scale to rate overall pain intensity and a list of 14 sensory and 11 affective pain descriptors ranked by intensity values from 1 - 5. Subjects look at the list of sensory and affective words and select words that describe their pain, including Oral Pain and Oral Pain with Swallowing. . The weighted scores assigned to the words are added to obtain a pain intensity score for the sensory and the affective components. The overall pain intensity is measured on a visual analogue scale which has a range of 1 - 10 with high scores indicating higher pain intensity. The sensory and affective pain scores are otained by adding all of the respective intensity values. The range of possible sensory scores is from 0 - 48 and the range of possible affective scores is from 0 - 37. The sensory and affective scores may be added together to obtain the total pain intensity score, which may range from 0 - 85.|Day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time|||units on a scale||Standard Deviation|Mean
2853258|NCT00031551|Secondary|What is the Toxicity of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment -Related Stomatitis?|Toxicity will be measured by the incidence of adverse events.|2 years||||event|||Number
2853259|NCT00031551|Primary|What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis?|Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain.|2 years|Participants withdrew and analyses were terminated before any data collected.||||||
2853260|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Glasgow Coma Scale (GCS).|The assessment scoring for the Glasgow Coma Scale is as follows: 15: no neuropsychological impairment; 12 - 14: mild neuropsychological impairment; 9 - 11: moderate neuropsychological impairment; 6 to 8: severe neuropsychological impairment; and <6: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.|||Participants|||Number
2853261|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days, and at 6 and 12 Months, as Measured by the Mini-Mental Status Examination (MMSE).|The assessment score for the Mini-Mental Status Examination is as follows: 27 - 30: no neuropsychological impairment; 23 - 26: mild neuropsychological impairment; 16 - 22: moderate neuropsychological impairment; 11 - 15 severe neuropsychological impairment; and <=10: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.|||Participants|||Number
2853262|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Mattis Dementia Rating Scale (MDRS)|The assessment scoring for the Mattis Dementia Rating Scale is as follows: 139 - 144: no neuropsychological impairment; 121- 138: mild neuropsychological impairment; 114 - 120: moderate neuropsychological impairment; 87 - 113: severe neuropsychological impairment; and <=86: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.|||Participants|||Number
2853263|NCT00031486|Secondary|Median Number of Reported AEs Describing Safety and Tolerance of Valacyclovir (VACV), Evaluated by the Number Adverse Events, Administered at a Dose of 2.0 Grams Given Orally 3 Times a Day for 90 Days.|The measure is the number of adverse events per subject. Adverse events were recorded from time of first dose of study drug through 6 months post start of study drug.|6 months||||Events per participants||Full Range|Median
2853264|NCT00031486|Secondary|Effect of Antiviral Therapy on Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) in Cerebral Spinal Fluid (CSF)|Few CSF specimens were collected on day 90, hence unable to calculate the difference in PCR at day 0 and day 90.[measured quantitatively by polymerase chain reaction (PCR)].|Day 0 and Day 90.|The number of participants analyzed is 0 because there specimens obtained were inadequate and insufficient to analyze.|||viral load|||Number
2853265|NCT00031486|Secondary|Effect of Study Medication on Quality of Life Measurements.|The SF-36 Questionnaire measures quality of life as reported by the subject. The questionnaire contains 36 questions, each questions can be assigned a maximum score of 100. For each subject, a perfect score would be 3600, hence the higher score is best. The calculated scores reported in the table below reflect the diffence between Day 0 (day study drug started) and Day 90, Day 0 (day study drug started) and Month 6, and Day 0 (day study drug started) and Month 12.|Day 0 and 90, Day 0 and Month 6 and Day 0 and Month 12|All subjects that were assessed at baseline and the following time points: 90 days, 6 and 12 months.|||Scores on a scale Change in SF-36||Full Range|Median
2853266|NCT00031486|Primary|Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS)|Number of subjects who were assessed to have no or mild neuropsychological impairment at 12 months using the Mattis Dementia Rating Scale. (A score of 121 or higher refects no or mild neuropsychological impairment.) Scale is: 139-144 normal; 121-139 mild; 114-120 moderate; 87-113 severe; and <=86 very severe.|One year post therapy.|All subjects that survived to 12 months and were assessed.|||Participants|||Number
2853267|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all subjects completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.||||participants|||Number
2853377|NCT00023595|Secondary|H02: All-cause (Unplanned and Elective) Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853268|NCT00031460|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by PCR at Anytime During the Initial 12 Months of Life.|Number of participants assessed to have a positive herpes simplex virus (HSV) DNA by polymerase chain reaction (PCR) in the cerebrospinal fluid (CSF) at any time during their initial 12 months of life after treatment. The PCR is a technique to help visualize copies of a piece of DNA.|post randomization - 12 months||||participants|||Number
2853269|NCT00031460|Secondary|Number of Participants With Two or Fewer Episodes of Cutaneous Recurrence of Herpes Simplex Virus (HSV) Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months||||participants|||Number
2853270|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment (Motor Scores).|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.||||participants|||Number
2853271|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: less than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Two of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment(mental); therefore, 2 placebo subject and 6 acyclovir subjects are included in the analysis.|||Participants|||Number
2853272|NCT00031447|Secondary|Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months||||participants|||Number
2853273|NCT00031447|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by Polymerase Chain Reaction (PCR) at Anytime During the Initial 12 Months of Life.|Number of participants with positive herpes simplex virus (HSV) DNA by polymerase cahin reaction (PCR) in the cerebrospinal fluid of subjects assessed during the initial 12 months of life.|post randomization at 12 months||||Participants|||Number
2853274|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Motor Scores)|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Three of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment (motor score); therefore, 1 placebo subject and 6 acyclovir subjects are included in the analysis.|||Participants|||Number
2853275|NCT00030992|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|10 years||||Participants|||Number
2853276|NCT00030992|Primary|Response Rate|Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|6 weeks||||Percentage of participants|||Number
2853277|NCT00030147|Primary|Center for Epidemiologic Studies-Depression Scale (CES-D)|Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Week 8|The analyses included those subjects who completed eight weeks of study|||Units on a scale||Standard Deviation|Mean
2853278|NCT00030147|Primary|Center for Epidemiologic Studies-Depression Scale (CES-D)|Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Baseline|The analyses included those subjects who started the study.|||Units on a scale||Standard Deviation|Mean
2853279|NCT00029536|Secondary|Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.||9 years||||mcg/mL||Standard Deviation|Mean
2853280|NCT00029536|Secondary|Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.|Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.|9 years||||ng/ml||Inter-Quartile Range|Median
2853281|NCT00029536|Secondary|Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately|Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately|9 years||||percentage of participants|||Number
2853286|NCT00029146|Secondary|Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years of randomization|On-treatment analysis removing four participants assigned to the surgical group who never underwent surgery and censoring on the day of surgery three participants assigned to the nonsurgical group who underwent EC-IC bypass surgery.|||percentage of participants||95% Confidence Interval|Number
2853287|NCT00029146|Secondary|Summary SS-QOL Score|Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||units on a scale||95% Confidence Interval|Mean
2853288|NCT00029146|Secondary|Modified Barthel Index 19-20|Modified Barthel Index dichotomized 19-20 vs <= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants|||Number
2853289|NCT00029146|Secondary|Modified Rankin 0-2|Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853290|NCT00029146|Secondary|Modified Rankin 0-1|Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853291|NCT00029146|Post-Hoc|Any Stroke or Death|2 yr Kaplan-Meier estimates of the proportions. Any stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853292|NCT00029146|Secondary|Death|2 yr Kaplan-Meier estimates of the proportions. Death of any cause|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853293|NCT00029146|Secondary|Fatal Stroke|2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator's opinion led directly to the participants death within 30 days of occurrence|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853294|NCT00029146|Secondary|Disabling Stroke|2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of <12/20 at the first scheduled return visit more than 3 months after the stroke occurred|within two years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853295|NCT00029146|Secondary|All Stroke|2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853296|NCT00029146|Primary|Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.|||percentage of participants||95% Confidence Interval|Number
2853297|NCT00029107|Primary|Percent of Patients in Remission|The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.|month 6||||percent of participants||95% Confidence Interval|Number
2853298|NCT00028262|Primary|Change in Cellular Granular Osmiophilic Deposits (GRODs) in Electron Micrographs of Peripheral White Blood Cells.|The GRODs in peripheral white blood cells from all patients before and during treatment were analyzed by transmission electron microscopy (TEM) at 30000xmagnification. Two investigators working independently of each other identified and counted the GRODs and the results were averaged.|10 years|Out of 10 enrolled subjects, one subject did not complete study and was lost to follow up.|||Average number of GRODs||95% Confidence Interval|Mean
2853299|NCT00028093|Primary|Change in Hepatitis C Virus RNA Levels During Phase I||From day 0 to day 3||||log(IU/mL)||Full Range|Median
2853300|NCT00027378|Primary|Depressive Symptoms|Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).|Average score as measured by participant's report on the Beck Depression Inventory (BDI).||||units on a scale||Standard Deviation|Mean
2853301|NCT00027378|Primary|Alcohol Use Behaviors|Alcohol use behaviors measured by drinks per week.|Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.|Participants were randomized to either fluoxetine-treated or placebo.|||standard drink (14 gr. alcohol)||Standard Deviation|Mean
2853302|NCT00027027|Secondary|Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants|||days||Standard Deviation|Mean
2853303|NCT00027027|Secondary|Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.|||days||Standard Deviation|Mean
2853304|NCT00027027|Secondary|Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.|||mL/kg||Standard Deviation|Mean
2853305|NCT00027027|Secondary|Pharmacokinetic Measurement of Volume of Central Compartment (Vc)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants|||mL/kg||Standard Deviation|Mean
2853306|NCT00027027|Secondary|Pharmacokinetic Measurement of Systemic Clearance (CL)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants|||mL/day/kg||Standard Deviation|Mean
2853307|NCT00027027|Secondary|Pharmacokinetic Measurement of Area Under the Curve (AUC)|Mean rhuMAb 2C4 serum concentrations versus nominal time profiles for the first two treatment cycles are presented for AUC micrograms per milliliters (ug/mL) by day. A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.|Days 1 (predose, 89 minutes following start of infusion and at 1.5, 4, and 8 hours postdose) 2, 5, 8 and 15 of Cycle 1; Days 1 (predose and 29 minutes following start of infusion) and 8 of Cycle 2|All enrolled participants|||ug*hr/mL||Standard Deviation|Mean
2853308|NCT00027027|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"Incidence of DLTs defined as any Grade 3 or 4 major organ toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2 or any subjectively intolerable toxicity felt by the investigator to be related to rhuMAb 2C4.~One participant in the 15.0 mg/kg dose group experienced a gastrointestinal hemorrhage on Day 16. This event was judged by the investigator to be related to study drug. The participant recovered in 3 days and continued to receive rhuMAb 2C4 beyond Cycle 2.This was the only DLT reported during the first two treatment cycles."|Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion|All enrolled participants who completed at least 2 cycles of study treatment.|||participants|||Number
2853309|NCT00027027|Primary|Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death|"For this protocol, an AE is defined any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, intercurrent illness, abnormal laboratory finding) that emerges or worsens relative to pretreatment baseline during the treatment or post-treatment periods, regardless of the suspected cause.~For this protocol an SAE was defined as any AE that occurred at any dose if:~It resulted in death (i.e., the AE caused or led to death),~It was life threatening,~It required or prolonged inpatient hospitalization,~It was disabling,~It resulted in a congenital anomaly/birth defect,~It may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above.~The primary cause of death for all reported cases was disease progression, and all of the deaths occurred following study discontinuation, with one death occurring within 4 weeks of the last treatment day."|Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)|All enrolled participants|||participants|||Number
2853310|NCT00025883|Primary|Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin||Baseline, 6 months, 12 months||||mg/dL||Inter-Quartile Range|Geometric Mean
2853311|NCT00025883|Primary|Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin|Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin|Baseline, 6 months, 12 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
2853312|NCT00023595|Secondary|H02: Cost of Care|Hospital costs and physician fees for US patients|index hospital admission|US patients with hospital bills|||2008 US Dollars||Standard Deviation|Mean
2853313|NCT00023595|Secondary|H01: Cost of Care|Hospital costs and physician fees for US patients|index hospital admission|US patients with hospital bills|||2009 US Dollars||Standard Deviation|Mean
2853316|NCT00023595|Secondary|H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale|"These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853317|NCT00023595|Secondary|H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale|"These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853318|NCT00023595|Secondary|H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale|"These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853319|NCT00023595|Secondary|H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale|"These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853320|NCT00023595|Secondary|H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale|"These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||percentage of participants|||Number
2853321|NCT00023595|Secondary|H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale|"These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||percentage of participants|||Number
2853322|NCT00023595|Secondary|H02: EQ-5D Health Status Index Score|"This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853323|NCT00023595|Secondary|H01: EQ-5D Health Status Index Score|"This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853324|NCT00023595|Secondary|H02: EQ-5D Visual Analog Scale|This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853325|NCT00023595|Secondary|H01: EQ-5D Visual Analog Scale|"Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853326|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale|These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853327|NCT00023595|Secondary|H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale|"These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853328|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale|"This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853329|NCT00023595|Secondary|H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale|"This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853330|NCT00023595|Secondary|H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale|"These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853331|NCT00023595|Secondary|H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale|"These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853332|NCT00023595|Secondary|H02: KCCQ Overall Summary Score|This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853333|NCT00023595|Secondary|H01: KCCQ Overall Summary Score|"This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853334|NCT00023595|Secondary|H02: KCCQ Clinical Summary Score|This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853335|NCT00023595|Secondary|H01: KCCQ Clinical Summary Score|"This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853336|NCT00023595|Secondary|H02: KCCQ Social Limitation|"These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853337|NCT00023595|Secondary|H01: KCCQ Social Limitation|"These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853338|NCT00023595|Secondary|H02: KCCQ Quality-of-Life Scale|These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853339|NCT00023595|Secondary|H01: KCCQ Quality-of-Life Scale|"These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853340|NCT00023595|Secondary|H02: KCCQ Total Symptoms|This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853341|NCT00023595|Secondary|H01: KCCQ Total Symptoms|"This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853342|NCT00023595|Secondary|H02: KCCQ Symptom Burden|"These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853343|NCT00023595|Secondary|H01: KCCQ Symptom Burden|"These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853344|NCT00023595|Secondary|H02: KCCQ Symptom Frequency|"These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853345|NCT00023595|Secondary|H01: KCCQ Symptom Frequency|"These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853378|NCT00023595|Secondary|H01: All-cause (Unplanned and Elective) Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853346|NCT00023595|Secondary|H02: KCCQ Symptom Stability|"This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853347|NCT00023595|Secondary|H01: KCCQ Symptom Stability|"This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853348|NCT00023595|Secondary|H02: KCCQ Physical Limitation Scale|"These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853349|NCT00023595|Secondary|H01: KCCQ Physical Limitation Scale|"Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.~."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853350|NCT00023595|Secondary|H02: SF-12 Mental Component Summary (MCS) Scale|"Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using mental regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the mental constant from the scoring table to the sum of the 35 products."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853351|NCT00023595|Secondary|H01: SF-12 Mental Component Summary (MCS) Scale|"Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using mental regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the mental constant from the scoring table to the sum of the 35 products."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853352|NCT00023595|Secondary|H02: SF-12 Physical Component Summary (PCS) Scale|"Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using physical regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the physical constant from the scoring table to the sum of the 35 products."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853353|NCT00023595|Secondary|H01:SF-12 Physical Component Summary (PCS) Scale|"Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using physical regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the physical constant from the scoring table to the sum of the 35 products."|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853354|NCT00023595|Secondary|H02: SF-36 Vitality Subscale|"These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853355|NCT00023595|Secondary|H01:SF-36 Vitality Subscale|"These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853356|NCT00023595|Secondary|H02: SF-36 Social Functioning Subscale|"These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853357|NCT00023595|Secondary|H01:SF-36 Social Functioning Subscale|"These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853358|NCT00023595|Secondary|H02: SF-36 Role Emotional Subscale|"These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853359|NCT00023595|Secondary|H01:SF-36 Role Emotional Subscale|"These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853360|NCT00023595|Secondary|H02: SF-36 Role Physical Subscale|"These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853361|NCT00023595|Secondary|H01:SF-36 Role Physical Subscale|"These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853362|NCT00023595|Secondary|H02: SF-36 Mental Health Subscale|"These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2853363|NCT00023595|Secondary|H01: SF-36 Mental Health Subscale|"Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)"|From enrollment to 3-year follow-up|Only patients with questionnaire data were analyzed.|||units on a scale||Standard Deviation|Mean
2853364|NCT00023595|Secondary|H02: B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up|From randomization to 24 months follow-up|Only patients with BNP data at baseline or 4 months were analyzed.|||pg/mL||Standard Deviation|Mean
2853365|NCT00023595|Secondary|H01: B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up|From randomization to 24 months follow-up|Only patients with BNP data at baseline or 4 months were analyzed.|||pg/mL||Standard Deviation|Mean
2853366|NCT00023595|Secondary|H02: LVEF by CMR Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.|From randomization to 24 months follow-up|Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
2853367|NCT00023595|Secondary|H01: LVEF by CMR Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.|From randomization to 24 months follow-up|Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
2853368|NCT00023595|Secondary|H02: LVEF by RN Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.|From randomization to 24 months follow-up|Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
2853369|NCT00023595|Secondary|H01: LVEF by RN Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.|From randomization to 24 months follow-up|Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
2853370|NCT00023595|Secondary|H02: LVEF by ECHO Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab|From randomization to 24 months follow-up|Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
2853371|NCT00023595|Secondary|H01: LVEF by ECHO Core Lab During Follow-up|Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab|From randomization to 24 months follow-up|Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.|||Percent ejection fraction||Standard Deviation|Mean
2853372|NCT00023595|Secondary|H02: Exercise Duration|Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test|From randomization to 24 months follow-up|Only patients with exercise duration data at baseline or 24 months were analyzed.|||meters||Standard Deviation|Mean
2853373|NCT00023595|Secondary|H01: Exercise Duration|Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test|From randomization to 24 months follow-up|Only patients with exercise duration data at baseline or 24 months were analyzed.|||minutes||Standard Deviation|Mean
2853374|NCT00023595|Secondary|H02: 6 Minute Walk Distance||From randomization to 24 month follow-up|Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.|||meters||Standard Deviation|Mean
2853375|NCT00023595|Secondary|H01: 6 Minute Walk Distance||From randomization to 24 month follow-up|Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.|||meters||Standard Deviation|Mean
2853382|NCT00023595|Secondary|H01: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853383|NCT00023595|Secondary|H02: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853384|NCT00023595|Secondary|H01: All-cause Mortality or Revascularization (CABG or PCI)|CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.|5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853385|NCT00023595|Secondary|H02: Stroke||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853386|NCT00023595|Secondary|H01: Stroke||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853387|NCT00023595|Secondary|H01: Stroke||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853388|NCT00023595|Secondary|H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853389|NCT00023595|Secondary|H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853390|NCT00023595|Secondary|H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853391|NCT00023595|Secondary|H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853392|NCT00023595|Secondary|H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853393|NCT00023595|Secondary|H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853394|NCT00023595|Secondary|H01: Cardiac Procedure: Heart Transplant||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853395|NCT00023595|Secondary|H02: Cardiac Procedure: Heart Transplant||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853396|NCT00023595|Secondary|H01: Cardiac Procedure: Heart Transplant||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853397|NCT00023595|Secondary|H01: Heart Failure Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853398|NCT00023595|Secondary|H02: Heart Failure Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853399|NCT00023595|Secondary|H01: Heart Failure Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853400|NCT00023595|Secondary|H01: All-cause Mortality or Heart-failure Hospitalization||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853401|NCT00023595|Secondary|H02: All-cause Mortality or Heart-failure Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853402|NCT00023595|Secondary|H01: All-cause Mortality or Heart-failure Hospitalization||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853403|NCT00023595|Secondary|H02: All-cause Mortality Within 30 Days After Randomization||30 days post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm|||participants|||Number
2853404|NCT00023595|Secondary|H01: All-cause Mortality Within 30 Days After Randomization||30 days post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853406|NCT00023595|Secondary|H01: Mortality or Cardiovascular Hospitalization||up to 10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853407|NCT00023595|Secondary|H01: Mortality or Cardiovascular Hospitalization||up to 5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853408|NCT00023595|Secondary|H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853409|NCT00023595|Secondary|H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853410|NCT00023595|Primary|H02: All-cause Mortality or Cardiovascular Hospitalization||5 years post randomization|The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853411|NCT00023595|Primary|H01: All Cause Mortality||10 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853412|NCT00023595|Primary|H01: All Cause Mortality||5 years post randomization|The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.|||participants|||Number
2853413|NCT00023452|Secondary|Cumulative Rate of Participants <12 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <12 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|||||||
2853414|NCT00023452|Secondary|Cumulative Rate of Participants <18 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <18 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|||||||
2853415|NCT00023452|Secondary|Cumulative Rate of HIV-Infected Participants With Culture-Confirmed or Probable TB Disease at 24 Months After Completion of Study Therapy|Cumulative TB disease rate was defined as number of HIV-infected participants with culture-confirmed TB (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)|||||||
2853416|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable TB Disease in HIV-Infected Participants Within 33 Months After Enrollment|Cumulative TB disease rate was defined as number of HIV-infected participants ≥2 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline to Month 33|||||||
2853417|NCT00023452|Secondary|Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment|Drug-susceptibility testing (DST) was performed on isolates of MTB obtained from participants who developed signs and symptoms of active TB disease (including sputum specimens or specimens from appropriate body site for extrapulmonary TB disease). DST was performed at site's local laboratory and sent to Sponsor for confirmatory susceptibility testing. DST included all drugs currently used to treat TB disease, including pyrazinamide (PZA) and fluoroquinolones. Susceptibility was tested for other drugs at the Sponsor laboratory at the following concentrations: INH, 0.02, 1.0, and 5.0 micrograms per milliliter (µg/mL) and rifampin (RIF), 1.0 µg/mL. Isolates resistant to RIF were assumed to be resistant to RPT.|Baseline up to Month 33|N equals the number of participants who developed active TB disease during the study for which DST was performed.|||percentage of participants|||Number
2853482|NCT00021541|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 years|Adverse event data is in compliance with DSMB (Data Safety Monitoring Board).|||Participants|||Count of Participants
2853418|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 33 months after enrollment (for those who completed therapy within 33 months) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Per Protocol Population: all enrolled and eligible participants (MITT Population) who completed study drug within targeted time period (11-12 3RPT/INH doses within 10-16 weeks; 240-270 INH doses within 35-52 weeks) or developed TB disease or died while on study therapy (or follow-up) but completed ≥75% of expected number of doses prior to event.|||TB cases per 100 participants w/followup|||Number
2853419|NCT00023452|Secondary|Percentage of Participants Who Completed the Treatment Regimen|Completion in the 3RPT/INH arm was defined as: received 12 doses of RPT/INH within 16 weeks (12 weeks optimal). However, participants were considered to have completed therapy if at least 11 doses of RPT/INH had been received (~90%) during the 16-week time period. Completion in the 9INH arm was defined as: received 270 doses of INH within 52 weeks (39 weeks optimal). However, participants were considered to have completed therapy if at least 240 doses of INH were received (~90%) during the 52-week period.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population|||percentage of participants|||Number
2853420|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH|Drug discontinuations for any reason associated with 3RPT/INH or 9INH included all reasons for discontinuation from study treatment, regardless of relationship to treatment.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population|||percentage of participants|||Number
2853421|NCT00023452|Secondary|Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone|Among participants concomitantly receiving methadone, the development of methadone withdrawal (defined as having >3 new symptoms for >7 days: nausea and vomiting, abdominal cramps, body aches, restlessness, irritability, dilated pupils, tremors, involuntary twitching, lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose flesh, or diarrhea).|Baseline to Month 33|||||||
2853422|NCT00023452|Secondary|Percentage of Participants With Death Due to Any Cause||Baseline up to Month 35|Safety Population|||percentage of participants|||Number
2853423|NCT00023452|Secondary|Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH|Drug toxicities (or AEs) were graded using Common Toxicity Criteria (CTC version 2.0, Publish Date April 30, 1999, Cancer Therapy Evaluation Program). Grade 3 and 4 drug toxicities associated with 3RPT/INH or 9INH were defined as treatment-related Grade 3 or 4 AEs (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population|||percentage of participants|||Number
2853424|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH|Discontinuation of study drug due to an adverse drug reaction associated with either 3RPT/INH or 9INH was defined as discontinuing treatment and/or study due to a treatment-related adverse event (AE) (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population: all participants who enrolled in the study and took at least 1 dose of study drug.|||percentage of participants|||Number
2853425|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment|Cumulative TB disease rate was defined as number of participants (regardless of age) with culture-confirmed TB disease (defined as positive culture for MTB]) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB, or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to 33 Months||||TB cases per 100 participants w/followup|||Number
2853426|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)|MITT Population|||TB cases per 100 participants w/followup|||Number
2853442|NCT00022763|Secondary|Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||hour||Standard Deviation|Mean
2853516|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-3 year intervention||||Minutes of MET-weighted MVPA˙||Standard Error|Mean
2853427|NCT00023452|Primary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment|Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis [MTB]) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, computed tomography [CT] scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for acid-fast bacilli [AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants with (w/)33 months of follow-up calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Modified Intention-to-Treat (MITT) Population: all participants who enrolled in study and were eligible (Ineligible=source TB case resistant to INH or rifampin; source TB case culture-negative for MTB; positive TST not confirmed; MTB drug susceptibility test results not available for source TB case; or TB disease at enrollment).|||TB cases per 100 participants w/followup|||Number
2853428|NCT00023322|Secondary|Histological Response at 5 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|5 years||||participants|||Number
2853429|NCT00023322|Primary|Histological Response at 3 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|3 years|Intention to treat|||participants|||Number
2853430|NCT00023309|Secondary|Histological Response|A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.|||participants|||Number
2853431|NCT00023309|Secondary|Biological Response|A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L).|week 196 from randomization|Intention to treat|||participants|||Number
2853432|NCT00023309|Secondary|Virological Response|A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL).|Week 196 from randomization|Intention to treat|||participants|||Number
2853433|NCT00023309|Secondary|HBeAg Loss at Week 196|Loss of hepatitis B surface antigen (HBsAg) at week 196|Week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.|||participants|||Number
2853434|NCT00023309|Primary|Maintained Combined Response (Virological, Biochemical and Histological Response).|A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|196 weeks from randomization|The analysis was intention to treat. Patients with missing values at week 196 were treated as random missing. No imputation was applied.|||participants|||Number
2853435|NCT00022763|Secondary|Number of Participants With Worst Local Injection Site Reactions|Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
2853436|NCT00022763|Secondary|Number of Participants Who Prematurely Withdrew Due to AE||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
2853437|NCT00022763|Secondary|Number of Participants Who Died||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
2853438|NCT00022763|Secondary|Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities|Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
2853439|NCT00022763|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Week 4 after discontinuation of therapy|Safety Analysis Population: All participants who received at least one dose of study medication were included.|||participants|||Number
2853440|NCT00022763|Secondary|AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)|The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||Ratio||Standard Deviation|Mean
2853441|NCT00022763|Secondary|Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)|Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||mcg/mL||Standard Deviation|Mean
2853443|NCT00022763|Secondary|Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||mcg/mL||Standard Deviation|Mean
2853444|NCT00022763|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.|||microgram hour per milliliter (mcg.h/mL)||Standard Deviation|Mean
2853445|NCT00016718|Primary|Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16|Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|At week 16|All Participant who enrolled in the study and with available HIV-RNA at week 16|||proportion of participants||95% Confidence Interval|Number
2853446|NCT00016718|Primary|Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16|Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|At week 16|All Participant who enrolled in the study and with available HIV-RNA at week 16|||proportion of participants||95% Confidence Interval|Number
2853447|NCT00016718|Primary|Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.~Comparisons between age groups were not required as per protocol."|At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3|All Participant who enrolled in the study|||proportion of participants||95% Confidence Interval|Number
2853448|NCT00014911|Post-Hoc|Serum Creatinine Levels for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Serum creatinine is a measure of renal function. Normal ranges are from 0.5 to 1.0 mg/dL for females and 0.7 to 1.2 mg/dL for males.|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat|||mg/dL||Full Range|Mean
2853449|NCT00014911|Post-Hoc|HbA1c Plasma Laboratory Values for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time. (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher)|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat|||HbA1c Percentage||Full Range|Mean
2853450|NCT00014911|Secondary|Percent of Participants With Detectable Fasting Basal C-Peptide Levels|C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making. C-peptide secretion is used to measure the function of transplanted islets. Higher levels indicate better islet function. Detectable fasting basal levels of C-peptide secretion are >=0.3 ng/ml.|Two years post first transplantation|Intent-to-Treat|||Percent of Participants|||Number
2853451|NCT00014911|Secondary|Percent of Participants That Achieved Insulin Independence From First Transplant|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|First transplantation until end of study (up to six years post final transplantation)|Intent-to-Treat|||Percent of Participants|||Number
2853452|NCT00014911|Secondary|Percent of Participants With Partial Islet Function One Year Post Final Islet Transplantation.|Partial islet function definition: a fasting basal C-peptide level >= 0.3 ng/mL and a continuing need for insulin or suboptimal glycemic control (Note: C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making). Adequate glycemic control is defined by: 1) a blood HbA1c level <6.5%, 2) a blood glucose level after an overnight fast not exceeding 140 mg/dL more than three times in any week and, 3) a 2-hour postprandial blood glucose level not exceeding 180 mg/dL more than four times per week|One year post receipt of final islet transplantation|Intent-to-treat|||Percent of Participants|||Number
2853480|NCT00021541|Other Pre-specified|Median Time to Progression Using the Conventional 1-Dimensional Response Evaluation Criteria in Solid Tumors (RECIST) Method|Median time to progression is defined as ≥20% increase in diameter based on volumetric analysis using the 1-dimensional RECIST method. Start of phase A or phase B to time of progression.|8 years|Phase B - Placebo group is not shown because this outcome measure only applies to the Phase A - Tipifarnib group.|||Months||95% Confidence Interval|Median
2853453|NCT00014911|Primary|Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation.|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1.) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|One year status post participant receipt of final islet transplantation|Intent-to-treat|||Percent of Participants|||Number
2853454|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||percentage of total lymphocytes||Full Range|Median
2853455|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||percentage of total lymphocytes||Full Range|Median
2853456|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 20||Baseline, Week 20|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||percentage of total lymphocytes||Full Range|Median
2853457|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||cells/mm^3||Full Range|Median
2853458|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||Cells/mm^3||Full Range|Median
2853459|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 20||Baseline, Week 20|"Participants accrued at the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."|||Cells/mm^3||Full Range|Median
2853460|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Clearance (CL/F)|Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0-24hr.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||L/hr/m^2||Inter-Quartile Range|Median
2853461|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||ng/mL||Inter-Quartile Range|Median
2853462|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24)|Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration.|Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||ng/mL||Inter-Quartile Range|Median
2853463|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h)|Pharmacokinetics were determined by non-compartmental analysis and AUC0-24hr calculated by the linear trapezoidal method.|Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.|||ng*hr/mL||Inter-Quartile Range|Median
2853464|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 96|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 96|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."|||percentage of participants||95% Confidence Interval|Number
2853481|NCT00021541|Secondary|Quality of Life (QOL)|"Parents of participants aged 6-18 years completed the Impact of Pediatric Illness (IPI) Scale about their child prior to the start of cycles 1, 4, 7, and 10 and then after every 6 cycles. The IPI Scale assesses QOL in 4 domains: adaptive behavior, emotional functioning, medical/physical status, and cognitive functioning. Responses to the 43 items are made on a 5-point Likert scale (1-5) ranging from not al all to a lot. Higher mean scores indicate better QOL. Parent total scores for participants on placebo were compared with scores from participants receiving tipifarnib on phase A."|Baseline to pre cycle 4|Participants analyzed includes only those whose parents completed the IPI Scale at baseline and pre cycle 4 on phase A.|||Total scores on a scale||Standard Deviation|Mean
2853465|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 48|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 48|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."|||percentage of participants||95% Confidence Interval|Number
2853466|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 24|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 24|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."|||percentage of participants||95% Confidence Interval|Number
2853467|NCT00006604|Primary|Number of Participants Who Died||From study entry up to week 96|Participants accrued at the final recommended dose for each group.|||participants|||Number
2853468|NCT00006604|Primary|Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV|"Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment.~The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team."|From study entry up to week 96|Patients accrued at the final recommended dose for each group.|||participants|||Number
2853469|NCT00004978|Secondary|Hepatic, Metabolic, and Cardiac Conditions|"Number of participants experiencing a serious non-AIDS event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy."|From randomization through study end - median of 7.6 years follow-up||||participants|||Number
2853470|NCT00004978|Secondary|Pattern of Use of Prophylaxis for Opportunistic Infections|Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.|last followup visit - median of 7.6 years follow-up|Intention to treat (ITT) - Medication use recorded on the last followup visit attended among all participants attending at least one followup visit.|||participants|||Number
2853471|NCT00004978|Secondary|Grade 4 Signs and Symptoms|Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section.|From randomization through study end - median of 7.6 years follow-up||||Participants|||Number
2853472|NCT00004978|Secondary|Number of Participants With Changes in Anti-retroviral Treatment (ART)|Number of participants who changed ART at least once during the study period.|From randomization through study end - median of 7.6 years follow-up||||participants|||Number
2853473|NCT00004978|Secondary|Plasma HIV RNA Levels|log10 HIV-RNA averaged throughout follow-up|From randomization through study end - median of 7.6 years follow-up|HIV-RNA measurement averaged over followup visits for all participants with at least one follow-up measurement.|||log10 HIV-RNA||Standard Deviation|Mean
2853474|NCT00004978|Secondary|Absolute CD4 Cell Counts Averaged Throughout Followup|Average of all available CD4+ cell counts measured at follow-up visits|from randomization through study end - median of 7.6 years follow-up|CD4+ cell counts averaged over all participants with at least one CD4+ measurement recorded during follow-up.|||cells/mm^3||Standard Deviation|Mean
2853475|NCT00004978|Secondary|Participants With a New Disease Progression Event or Death|Includes first new episode of: CDC Category C 1993 AIDS-defining events plus invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through 15 November 2008 - median of 7.6 years follow-up||||participants|||Number
2853476|NCT00004978|Secondary|Number of Participants Who Died From Any Cause||from randomization through study end - median of 7.6 years follow-up||||participants|||Number
2853477|NCT00004978|Secondary|New or Recurrent Serious HIV Disease Progression Event Including Death|Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease.|from randomization through study end - median of 7.6 years follow-up|ITT|||participants|||Number
2853478|NCT00004978|Primary|New or Recurrent HIV Disease Progression Event Including Death|Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through study end - median of 7.6 years follow-up|ITT|||participants|||Number
2853479|NCT00021541|Other Pre-specified|Median Time to Progression Using the 2-Dimensional World Health Organization (WHO) Solid Tumor Method|Median time to progression is defined as ≥25% increase in area based on volumetric analysis using the 2-dimensional WHO solid tumor method.|8 years|Phase B- Placebo group is not shown because this outcome measure only applies to the Phase A - Tipifarnib group.|||Months||95% Confidence Interval|Median
2853483|NCT00021541|Primary|Median Time to Progression|Median time to progression is defined as a greater than or equal to 20% increase increase in the sum of the volume of all index lesions based on volumetric analysis utilizing magnetic resonance imaging (MRI).Start of phase A or phase B to time of progression.|8 years|phase A - 62 started and 2 were ineligible = 60 phase B - 43 started|||Months||95% Confidence Interval|Median
2853484|NCT00018031|Primary|Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response|"HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects.~Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response"|Day 3 and Day 28|Participants with Virologic decline at both Day 3 and absolute HCV VL at Week 28 were analyzed|||participants with post treatment svr|||Number
2853485|NCT00015457|Secondary|Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo|Self reported duration of effect in weeks.|3 months|Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.|||weeks||Full Range|Median
2853486|NCT00015457|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score|Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.|1-2 month maximal rating|Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data|||units on a scale||Standard Deviation|Mean
2853487|NCT00013611|Secondary|New or Recurrent Serious Disease Progression Events or Death|"Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease.~A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
2853488|NCT00013611|Secondary|CD4+ Cell Count|Mean CD4+ cell count (cells per cubic mm) averaged over follow-up|Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest .||||cells per cubic mm||Standard Error|Mean
2853489|NCT00013611|Secondary|Grade 4 Clinical Events|Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|The outcome is the number of participants experiencing at least one grade 4 event.|||Participants|||Number
2853490|NCT00013611|Secondary|New or Recurrent Disease Progression Events|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease.~AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
2853491|NCT00013611|Secondary|All-cause Mortality|Number of participants who died.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
2853492|NCT00013611|Primary|New or Recurrent Disease Progression Events, as Defined, or Death.|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause.~AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier||||Participants|||Number
2853493|NCT00010803|Secondary|Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.|Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).|6 months/annually|Final test scores were imputed for participants who did not have a cognitive exam during the year before death (n=234) or dropout (n=154) or during the month before censoring for dementia (n=70). Factors in imputed model included treatment group, demographic and health history variables, study site, and other cognitive scores. Higher Z-scores worse|||Z-score units||95% Confidence Interval|Mean
2853494|NCT00010803|Secondary|Number of Participants With the Indicated Cardiovascular Disease or Mortality|Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality|6 months|Total cohort of 3069 based on same design as primary outcome, ITT.|||Participants|||Number
2853495|NCT00010803|Primary|Number of Participants With Incident Dementia|All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.|Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up|Subjects developing incident dementia during trial in each group, intention to treat (ITT).|||Participants|||Number
2853517|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-2 year intervention||||Minutes of MET-weighted MVPA˙||Standard Error|Mean
2853518|NCT00006305|Secondary|Number of Participants With Death, Myocardial Infarction, or Stroke||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)|||participants|||Number
2853496|NCT00010439|Secondary|Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.|Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.|Before and 12 months after treatment with alendronate|Per protocol|||participants|||Number
2853497|NCT00010439|Primary|Number of Participants With Increased Bone Mineral Density|Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)|at 12 months|per protocol|||participants|||Number
2853498|NCT00007644|Primary|All Cause Mortality|Number of deaths from any cause.|From date of randomization until date of death from any cause, assessed until end of study, up to 16 years||||Participants|||Count of Participants
2853499|NCT00007475|Secondary|Determine Whether Renal Transplantation in Patients Whose Elevated FPF Levels Have Been Reduced for a Sustained Period is Associated With a Reduced Prevalence of Recurrent FSGS.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants whose post-transplantation follow-up yields 1 or more assayed FPF levels||||||
2853500|NCT00007475|Secondary|Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants with FPF levels assayed following immunosuppressive therapies (currently none). Note: its assay had not yet been developed to an extent that it could be applied beyond the provisional values assayed for 3 of the first 4 enrollees using a version implemented by Dr.Virginia Savin, VA Medical Center/Kidney Institute, Kansas City, Missouri||||||
2853501|NCT00007475|Secondary|Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study||||1- albumin glomerular permeability ratio||Full Range|Mean
2853502|NCT00007475|Secondary|Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects|"No RNA expression profiles have been obtained as FSGS Permeability Factor (FPF) levels NOT available -- its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial.~Note that provisional values (targeting current candidate molecule: cardiotrophin-like cytokine 1) were assayed for 3 of the first 4 enrollees using assay by Dr. Virginia Savin, whose lab is actively investigating a molecular identification of FPF using an isolation approach based on sequential precipitation results in a 100-fold purification, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF include:~Terry Phillips at NIH developed an assay that looked promising but after his retirement it has not been possible for other researchers to get this working.~Avi Rosenberg, NCI has developed a promising ELISA-style assay, as well as some work in a mass spectrometry assay, and this is being further refined."|End of study|Participants with FPF, without FPF and control subjects who have also had RNA expression profiling done in PBMCs.||||||
2853503|NCT00007475|Primary|Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide.|"Outcomes for FSGS occurring in native kidneys:~A. Complete remission: proteinuria <0.3 g/d ; B. Partial remission: proteinuria between 0.3 and 2 g/d ; C. Incomplete response: proteinuria between 2 and 3.5 g/d ; D. Relapse: return to proteinuria ≥3.5 g/d ; Note that counts within each category A-D may be summarized relative to remaining categories, as a proportion (relative to complement of the whole group count) with calculations implicitly based on zero/one valued binary variables, whose means are proportions, so to report 95% confidence intervals calculated using an exact binomial distribution."|every 3 months up to a year followed with native kidneys|all participants, regardless of amount of follow-up|||proportion of participants with outcome||95% Confidence Interval|Mean
2853598|NCT00001959|Secondary|Proteinuria After Treatment||12 months from baseline||||g/d||Inter-Quartile Range|Median
2853599|NCT00001959|Primary|Decrease in GFR During Treatment Period||12 months from baseline|ITT|||ml/min/1.73 m2||Inter-Quartile Range|Mean
2853504|NCT00007345|Secondary|Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression|Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).|4 hours, 24 hours, and 48 hours after Romidepsin|ABCB1 expression of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.|||Fold change||Full Range|Median
2853505|NCT00007345|Secondary|Fold Change in Histone Acetylation|Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a ≥ 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).|4 hours, 24 hours, and 48 hours after Romidepsin|Global histone acetylation of all samples at pretreatment was designated as 1; values at other time points for each patient were calculated relative to the corresponding pretreatment value.|||Fold change||Full Range|Median
2853506|NCT00007345|Secondary|Time to Progression|Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|Until disease progression, or 30 days following off study date||||Months||95% Confidence Interval|Median
2853507|NCT00007345|Secondary|Median Number of Cycles of Depsipeptide Administered|Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.|83 cycles (i.e., each cycle is 21 days)||||Cycles per patient||Full Range|Median
2853508|NCT00007345|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|147 months and 5 days||||participants|||Number
2853509|NCT00007345|Primary|Duration of Response (DOR)|DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 127 months||||Months||Full Range|Median
2853510|NCT00007345|Primary|Number of Participants With a Response|A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 56.5 days|Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.|||participants|||Number
2853511|NCT00006489|Secondary|Penn Alcohol Cravings Scale|The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)||||percentage of days||95% Confidence Interval|Mean
2853512|NCT00006489|Primary|Drinking Timeline Follow-back Interview (TFBI)|The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)||||percentage of days||95% Confidence Interval|Mean
2853513|NCT00006489|Primary|Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)|The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.|Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)||||units on a scale||95% Confidence Interval|Mean
2853514|NCT00006411|Secondary|Endothelial Cell Density (ECD)|ECD (cells/mm2)was measured on a subset of the overall Cornea Donor Study cohort who participated in the Specular Microscopy Ancillary Study|10 year ECD|Of 1,090 eligible participants enrolled in the CDS, the SMAS included 609. A gradable endothelial image at 10 years was available for 176 participants. Among the other 433 participants, 105 had a graft failure, 100 died, 103 completed less than 10 years of CDS follow up, and 125 did not have a 10-year image for other reasons.|||ECD (cells/mm2)||Inter-Quartile Range|Median
2853515|NCT00006411|Primary|Graft Failure|# eyes with graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of three consecutive months. Only one eye per participant was included in the study.|Baseline to 10 Years of Follow Up||||participants|eyes||Number
2853519|NCT00006305|Primary|Number of Participants With All-Cause Mortality||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)|||participants|||Number
2853520|NCT00006289|Primary|McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.||||units on a scale||Standard Error|Mean
2853521|NCT00006289|Primary|Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.||||units on a scale||Standard Deviation|Mean
2853522|NCT00006289|Primary|Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )|"Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.||||mm||Standard Error|Mean
2853523|NCT00006184|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years||||Participants|||Count of Participants
2853524|NCT00006184|Primary|Immune Response|Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.|105 days|This outcome measure was only pre-specified to be measured in the recipient Arm/Group.|||Particpants|||Number
2853525|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure at 12 months after intervention|12 months after intervention||||mL/min||Standard Deviation|Mean
2853526|NCT00006178|Primary|Serum Creatinine Concentration|measures at 12 months after intervention|12 months after intervention||||umol/L||Standard Deviation|Mean
2853527|NCT00006178|Primary|Serum Creatinine Concentration|measures at 6 months after intervention|6 months after intervention|Analysis includes all participants in the study. Analysis was per protocol.|||umol/L||Standard Deviation|Mean
2853528|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure 6 months after intervention|6 month after intervention||||mL/min||Standard Deviation|Mean
2853529|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|12 months|Participants with available data at 12mo. All others were unable to provide data at this time point.|||percentage of participants|||Number
2853530|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|6 months|Participants with available data at 6mo. All others were unable to provide data at this time point.|||percentage of participants|||Number
2853531|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|3 months|Participants with available data at 3mo. All others were unable to provide data at this time point.|||percentage of participants|||Number
2853532|NCT00006156|Secondary|Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels||24 hours||||participants||Standard Error|Mean
2853533|NCT00006156|Primary|Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.||24 hours||||participants||Standard Error|Mean
2853534|NCT00006164|Secondary|SF-36 Mental Health Summary Score|Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.|0.5, 1.5, 2.5, and 3.5 years after randomization|At each visit the analysis population is the number who completed the questionaire|||units on a scale||Standard Deviation|Mean
2853535|NCT00006164|Secondary|SF-36 Physical Function Summary Score|Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.|0.5, 1.5, 2.5, and 3.5 years after randomization|At each visit the analysis population is the number who completed the questionaire|||units on a scale||Standard Deviation|Mean
2853536|NCT00006164|Secondary|SF-36 Vitality Summary Score|Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.|0.5, 1.5, 2.5, and 3.5 years after randomization|At each visit the analysis population is the number who completed the questionaire|||units on a scale||Standard Deviation|Mean
2853537|NCT00006164|Secondary|Presumed Hepatocellular Carcinoma (HCC)|"Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if:~A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC.~AFP> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC.~A progressively enlarging hepatic lesion starting as a new defect resulting in patient death.~A new hepatic defect with at least 1 characteristic scan and:~Increase in size over time or~Increasing AFP rising to a level of >200 ng/ml"|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853538|NCT00006164|Secondary|Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.|Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization|Numbers of participants at 1.5 and 3.5 years are the number with biopsies at those time points|||units on a scale||Standard Deviation|Mean
2853539|NCT00006164|Secondary|Serious Adverse Events|"A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following:~Death~Is life threatening (risk of death at the time of the event)~Requires in-patient hospitalization or prolongation of existing hospitalization~Results in persistent or significant disability/incapacity~Congenital abnormality or birth defect~Trial outcomes (except death) were not considered serious adverse events."|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853540|NCT00006164|Primary|Hepatic Encephalopathy|Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853541|NCT00006164|Primary|Spontaneous Bacterial Peritonitis|Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853542|NCT00006164|Primary|Ascites|"Any abdominal fluid which is:~Mild, moderate or marked on ultrasound; or~Progressive on serial physical examinations; or~Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is mild (barely detectable) on physical examination requires ultrasound confirmation that is mild, moderate or marked ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition."|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853543|NCT00006164|Primary|Variceal Hemorrhage|A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853544|NCT00006164|Primary|Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits|Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853545|NCT00006164|Primary|Development of Hepatocellular Carcinoma (HCC)|"A diagnosis of development of hepatocellular carcinoma (HCC) was based on either~Histology showing HCC (from a biopsy, surgery, or autopsy) or~A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml."|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853546|NCT00006164|Primary|Death From Any Cause||1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853547|NCT00006164|Primary|Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies|For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization|Patients with Ishak fibrosis score <5 at baseline and at least one follow-up biopsy|||Participants|||Count of Participants
2853548|NCT00006164|Primary|Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points|Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study|1400 days (3.85 years) post randomization||||Participants|||Count of Participants
2853549|NCT00006151|Primary|Abstinence Rate|The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.|1 year||||participants|||Number
2853550|NCT00005937|Primary|Red Blood Cell Transfusion Independence|Red blood cell transfusion independence was documented as time from last transfusion of red cells to last day of transfusion free follow-up. Independence or response to the intervention was assessed by weekly blood counts. Transfusion independence was defined as no transfusion requirement for a 3 month period. Complete hematologic response is defined as the normalization of affected cells lines and less than 5% marrow blasts present. Partial hematologic response is defined as greater than 50% improvement from baseline to normal levels of all cell counts and greater than 50% decrease in marrow blasts.|6 months||||participants|||Number
2853551|NCT00005908|Primary|Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years|"Specimens from 21 patients. Analysis was per protocol and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together."|||Participants|||Number
2853552|NCT00005908|Primary|Complementary Deoxyribonucleic Acid (cDNA) Expression|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years||||Participants|||Number
2853553|NCT00005908|Primary|Overall Clinical Response Rate|Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.|6 years|Combined data from 2 dose levels in 29 evaluable patients.|||Percentage of participants|||Number
2853554|NCT00005908|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|6 years||||Participants|||Number
2853555|NCT00005906|Secondary|Number of Participants With Liver Function Abnormalities|"One or more abnormality of the following liver function tests:~Alkaline phosphatase above 116 i.u.~SGPT above 41 i.u.~SGOT from 34 i.u.~Total bilirubin above 1.0 mg/dl"|Six months||||Participants|||Number
2853556|NCT00005906|Primary|Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms.|"Octreotide treatment will be considered successful if the reported pain/symptom score is reduced by at least 2 levels at termination of treatment.~A simple visual numeric distress scale ranging from zero to 10 will be employed to rate the severity of individual symptoms. The best score is zero, which means absence of symptoms and the maximal is 10, meaning that the symptoms are very severe."|Six months|Four patients with lymphangioleiomyomatosis and lymphangioleiomyomas and chylous effusions treated with octreotide injections by the subcutaneous route to determine whether the size of the tumors and effusions decrease with the therapy|||Participants|||Number
2853557|NCT00005906|Primary|Number of Participants With a Reduction in Total Tumor Volume of at Least 20%.|Octreotide treatment will be considered successful if the patient receiving treatment for six months shows a reduction in total tumor mass/ fluid collection or reaccumulation of at least 20%.|Six months||||Participants|||Number
2853558|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 6 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
2853559|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 36 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
2853560|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 30 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
2853561|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 24 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
2853562|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 18 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
2853563|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 12 months after first dose|All subjects received Pamidronate for 3 years.|||Z-score||Standard Deviation|Mean
2853564|NCT00005669|Secondary|Change in Body Fat by Bod Pod|Change in body fat mass measured by air displacement plethysmography (kg)|6 months||||kg||95% Confidence Interval|Mean
2853565|NCT00005669|Secondary|Change in Body Fat by DEXA|Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)|6 months|ITT, multiple imputation model for missing data under a missing-at-random assumption|||kg||95% Confidence Interval|Mean
2853566|NCT00005669|Secondary|Change in Body Weight|Change in body weight (kg)|6 months||||kg||95% Confidence Interval|Mean
2853567|NCT00005669|Secondary|Change in Body Weight as Determined by BMI|Change in body weight as determined by body mass index (kg/m2)|6 months||||kg/m2||95% Confidence Interval|Mean
2853568|NCT00005669|Primary|Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).|Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile_data_files.htm for details.|6 months||||Units on a scale||95% Confidence Interval|Mean
2853569|NCT00004980|Secondary|Responder Status|"Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions.~Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline"|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF|||Participants|||Number
2853570|NCT00004980|Secondary|Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions|Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)||||Units on a scale||Standard Deviation|Mean
2853571|NCT00004980|Secondary|Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions|Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF|||Score on a scale||Standard Deviation|Mean
2853572|NCT00004980|Primary|Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions|Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
2853573|NCT00004732|Secondary|Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).|4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|4 years||||Percentage||Standard Error|Mean
2853574|NCT00004732|Primary|Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.|The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|30 days and 4 years||||Percentage||Standard Error|Mean
2853575|NCT00004635|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 60 months||||Participants|||Count of Participants
2853576|NCT00004635|Primary|Time to Progression|Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.|36 months|Per protocol. First intervention phase-73 participants (thalidomide) were analyzed and 0 was excluded; 74 participants were analyzed (placebo) and 1 was excluded for discrepancy in data entry. Crossover phase-50 participants were analyzed (thalidomide)and 1 was excluded for discrepancy in data entry, 38 participants for placebo and 0 excluded.|||months||95% Confidence Interval|Median
2853577|NCT00004563|Secondary|DLCO|diffusing capacity of the lungs for carbon monoxide|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.|||% of predicted||Standard Error|Mean
2853578|NCT00004563|Secondary|Total Lung Capacity|expressed as a percentage of the predicted value|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.|||% of predicted||Standard Error|Mean
2853579|NCT00004563|Primary|Forced Vital Capacity|The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC.|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.|||% of predicted||Standard Error|Mean
2853580|NCT00004562|Secondary|Number of Participants With Secondary Outcomes (Safety Events)|Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median||||participants|||Number
2853581|NCT00004562|Primary|Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)|Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median||||participants|||Number
2853582|NCT00004547|Secondary|Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue|Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.|once during surgery|This outcome measure was not analyzed because it was not feasible.||||||
2853583|NCT00004547|Secondary|Quality of Life Questionnaire Score|"The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time.~For detailed information about the questionnaires, please see the Protocol Link module."|preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study|This outcome measure was not evaluated due to poor patient compliance.||||||
2853584|NCT00004547|Secondary|Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed|Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).|Perioperative day 7-12 after surgery|This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).||||||
2853585|NCT00004547|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|only assessed during the perioperative period (i.e. up to 90 days following surgery)|188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).|||Participants|||Number
2853586|NCT00004547|Primary|Number of Participants With a Response|Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.|Patients were assessed every three months for one year and then every 6 months||||Participants|||Number
2853587|NCT00004547|Primary|Number of Participants With Disease-free Survival|Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.|On study date until the first scan with imageable disease, assessed up to 100 months or more.|This outcome measure was not analyzed because information was not consistently available.||||||
2853588|NCT00001984|Secondary|Monocyte Count||4 day post operation||||cells/mm3||Full Range|Median
2853589|NCT00001984|Primary|Rise in Serum Creatineine Above Posttransplant Nadir||24-32 days post operation||||parcentage rise in serum creatineine||Full Range|Median
2853590|NCT00001984|Secondary|Creatinine at 2 Years|Creatinine level of donor recepient at 2 years after transplantation|2 years post operation||||mg/dL||Standard Deviation|Mean
2853591|NCT00001984|Secondary|Creatinine Level at Year 1 Post Operation||1 year post operation||||mg/dL||Standard Deviation|Mean
2853592|NCT00001984|Secondary|Creatinine Level at 6 Month Post Operation||6 month post operation||||mg/dL||Standard Deviation|Mean
2853593|NCT00001984|Primary|Rejection Day of Onset|The day on which the rejection onsets.|From day 1 to 2 years post operation||||day||Full Range|Median
2853594|NCT00001984|Primary|Number of Patients With Renal Allograft Rejection|The renal allograft tolerance was evaluated clinically, by flow cytometry, and by protocol biopsies analyzed immunohistochemically and with real-time polymerase chain reaction.|from day 1 to 24 months post operation||||participant|||Number
2853595|NCT00001962|Secondary|Change in the Transfusion Requirements, Overall Survival.||3 and 6 months|||||||
2853596|NCT00001962|Primary|Daclizumab Hematologic Response|"Daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. The Diamond Blackfan anemia arm was closed due to the lack of accrual. The hematologic response will be evaluated at 3 months.~A complete hematologic response will be considered an achievement of normal blood counts. A partial response was defined as any response less than a complete response. The primary endpoint was a hematologic response in at least one affected peripheral blood count parameter, as determined by 3 separate measurements in the first 12 weeks after completion of the infusion."|3 months|The daclizumab hematologic response was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan arm was closed due to lack of accrual.|||participants|||Number
2853597|NCT00001959|Secondary|Proportion of Patients With Positive Change in GFR||12 months from baseline||||participants|||Number
2853600|NCT00001941|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 months|Data is not available separately per cohort.|||Participants|||Number
2853601|NCT00001941|Primary|Percentage of Participants With an Overall Response Rate|Participants overall response rate was defined as complete response (CR) + partial response (PR) from study consent until progression was measured. Responses was assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; and progressive disease is a >=25% increase in leukemic cell count|up to 220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.|||Percentage of participants|||Number
2853602|NCT00001941|Primary|Overall Survival|Measured from the time the patient is consented until death.|132.6 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.|||Weeks||95% Confidence Interval|Median
2853603|NCT00001941|Primary|Duration of Response|Duration of response was defined as the interval from the time response is first achieved to the time progression from the best response is detected. Responses are assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; stable disease is patients who did not meet the criteria; and progressive disease is a >=25% increase in leukemic cell count.|21-220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.|||Weeks||Full Range|Median
2853604|NCT00000392|Secondary|Change in Neurocognitive Performance Domain z Scores From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months||||z score||Standard Error|Mean
2853605|NCT00000392|Primary|Change in Global Neurocognitive Performance z Score From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months||||z score||Standard Error|Mean
2853606|NCT00001832|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10.5 months||||Participants|||Number
2853607|NCT00001832|Primary|Clinical Response|Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.|Every three to four weeks after the treatment, for up to 5 years.||||Participants|||Number
2853608|NCT00001723|Secondary|Effect of Race on Change in Weight (kg)|Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)|baseline to 6 months|Multiple imputation analysis|||kg||Standard Error|Mean
2853609|NCT00001723|Secondary|Change in Body Fat (kg)|body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)|baseline to 6 months|Multiple Imputation analysis|||kg||Standard Error|Mean
2853610|NCT00001723|Secondary|Change in Body Mass Index|BMI is calculated in kg/m2. Change from baseline to 6 months of treatment|baseline to 6 months|Muliple imputation analysis|||kg per square meter||Standard Error|Mean
2853611|NCT00001723|Secondary|Change in Body Weight|Weight in kg|baseline to 6 months|Multiple imputation analysis|||kg||Standard Error|Mean
2853612|NCT00001723|Primary|Change in BMI Standard Deviation Score|Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.|baseline to 6 months|Multiple imputation analysis|||Standard Deviation Score||Standard Error|Mean
2853613|NCT00001703|Secondary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|88 months||||participants|||Number
2853614|NCT00001703|Primary|Percentage of Participants Who Generated an Immune Response|The immunological response was assessed by in-vitro T cell cytokine production enzyme-linked immunosorbent spot (ELISPOT). From each patients, post-vaccination peripheral blood mononuclear cells (PBMC) were compared to pre-vaccination as a baseline. A positive ELISPOT result for the patients was defined as a total number of experimental spots in the post-vaccination sample of more than twofold above the total spots in the pre-vaccination sample.|30 months||||percentage of participants|||Number
2853615|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score|minimum score = 10; maximum score = 90; lower score considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks||||scores on a scale||95% Confidence Interval|Median
2853616|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)|minimum score = 10; maximum score = 50; lower score is considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks||||scores on a scale||Full Range|Median
2853617|NCT00001656|Other Pre-specified|Change in Body Mass Index (BMI)|BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)|8 week double-blind study period; baseline and 8 weeks||||kg/m²||Standard Deviation|Mean
2853618|NCT00001656|Other Pre-specified|Change in Weight||8 week double-blind study period; baseline and 8 weeks||||kilograms||Standard Deviation|Mean
2853619|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Anxiety|Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853620|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Mania|Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853621|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Depression|Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853622|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Psychosis|Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853623|NCT00001656|Primary|Change in the Scale for the Assessment of Positive Symptoms|Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853624|NCT00001656|Primary|Change in the Brief Psychiatric Rating Scale-24|A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853625|NCT00001656|Primary|Change in the Clinical Global Impression Severity of Symptoms Scale|Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853626|NCT00001656|Primary|Change in the Scale for the Assessment of Negative Symptoms|Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome|8 week double-blind study period; baseline and 8 weeks||||Scores on a scale||95% Confidence Interval|Mean
2853627|NCT00001596|Secondary|Change in 6 Minute Walk Test (12 Months)|Change from baseline of the 6 minute walk test (6MWT) at 12 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.|||meters||Standard Deviation|Mean
2853628|NCT00001596|Secondary|Change in 6 Minute Walk Test (36 Months)|Change from baseline of the 6 minute walk test (6MWT) at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.|||meters||Standard Deviation|Mean
2853629|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (12 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 12 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.|||% of predicted volume||Standard Deviation|Mean
2853630|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (36 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 36 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.|||% of predicted volume||Standard Deviation|Mean
2853631|NCT00001596|Secondary|Change in Total Lung Capacity (12 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 12 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.|||% of predicted volume||Standard Deviation|Mean
2853632|NCT00001596|Secondary|Change in Total Lung Capacity (36 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 36 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.|||% of predicted volume||Standard Deviation|Mean
2853633|NCT00001596|Secondary|Change in Forced Vital Capacity (12 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 12 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.|||% of predicted volume||Standard Deviation|Mean
2853634|NCT00001596|Primary|Change in Forced Vital Capacity (36 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 36 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.|||% of predicted volume||Standard Deviation|Mean
2853635|NCT00001586|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|13 years, 10.5 months|The low-intermediate risk patients received no treatment so their tissue/blood was not analyzed for change.|||Participants|||Number
2853636|NCT00001586|Primary|Change in Gene Expression Post Chemo|Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.|6 hours post treatment, and 24 hours post treatment|There were only 12 patients analyzed for various reasons such as timing of treatment, ability to collect samples, and viability of samples.|||Percent change in cells|||Number
2853637|NCT00001575|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|16 yrs 18 days||||participants|||Number
2853638|NCT00001575|Primary|Clinical Response|Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.|Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle.|Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).|||participants|||Number
2853639|NCT00001575|Primary|Maximum Tolerated Dose (MTD) of 90Y-HAT|Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.|Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.|Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).|||mci|||Number
2853640|NCT00001566|Secondary|Median Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5.4 years||||Years||Full Range|Median
2853641|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation|Immune response was defined as a percent specific lysis of >10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides.|Once per enrollment||||Participants|||Number
2853642|NCT00001566|Primary|Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0.|5 years|12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides.|||Participants|||Number
2853643|NCT00001566|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years||||Participants|||Number
2853644|NCT00001566|Secondary|Percent of Participants: Event Free Survival|Event free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease.|5 years||||Percentage of participants|||Number
2853645|NCT00001566|Secondary|Percentage of Participants Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5 years||||Percentage of participants|||Number
2853646|NCT00001566|Primary|Number of Participants With an Immune Response to the Translocation Breakpoint Peptide|Immune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines.|5 years||||Participants|||Number
2853647|NCT00001566|Primary|The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy|CD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been <10 years of age and sustained a CD4 count of <300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count > 500 cells/mcl at any timepoint within 6 months of completing chemotherapy.|2 to 6 months||||Percentage of participants|||Number
2853648|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.|20 weeks post vaccination||||Participants|||Number
2853649|NCT00001305|Primary|Proportion of Subjects Who Met Criteria of Increase in Growth Rate Since Baseline.|The proportion of subjects who met the study criteria of at least 50% increase in growth rate since baseline.|1 year|The analyses included only those subjects who completed 1 year of study|||Participants|||Count of Participants
2853650|NCT00001304|Primary|Urine Calcium Excretion Level|Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/24 h||Standard Deviation|Mean
2853651|NCT00001304|Secondary|Urinary Creatinine Clearance|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||ml/min||Standard Deviation|Mean
2853652|NCT00001304|Secondary|Serum Phosphorus Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/liter||Standard Deviation|Mean
2853653|NCT00001304|Secondary|Serum Magnesium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/liter||Standard Deviation|Mean
2853654|NCT00001304|Primary|Serum Calcium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||mmol/liter||Standard Deviation|Mean
2853655|NCT00001304|Secondary|Serum 25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||ng/ml||Standard Deviation|Mean
2853656|NCT00001304|Secondary|Serum 1,25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study|||pg/ml||Standard Deviation|Mean
2853657|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile||36 months or death||||Other - Percentile||Standard Deviation|Mean
2853658|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile||36 months or death||||Other - Percentile||Standard Deviation|Mean
2853659|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile||36 months or death||||Other - Percentile||Standard Deviation|Mean
2853660|NCT00001262|Primary|Language Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate language development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - Months||Standard Deviation|Mean
2853661|NCT00001262|Primary|Personal-Social Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate personal-social development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - Months||Standard Deviation|Mean
2853662|NCT00001262|Primary|Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate fine motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - Months||Standard Deviation|Mean
2853663|NCT00001262|Primary|Gross Motor Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate gross motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death||||Other - months||Standard Deviation|Mean
2853664|NCT00001213|Primary|Number of Eyes With a Corneal Cystine Crystal Score (CCCS) Response|"Response is defined as a decrease from baseline of at least 1 in Corneal Cystine Crystal Score (CCCS) at any time on study when baseline CCCS is greater than or equal to 1, or CCCS does not increase at least 1 at any time on study when baseline CCCS is less than 1.~The CCCS is based on a library of slit-lamp photographs of corneas with increasing crystal densities (0-3). Slit-lamp photos were to be taken to assess the extent of the corneal crystal accumulation. To minimize bias when assessing the extent of corneal crystal accumulation, photos were centrally graded at the National Eye Institute (NEI) where each photo was graded independently by masked graders. If more than one CCCS was recorded in a given study year, the highest (worst) CCCS value was used for that year.~The results were obtained from a combined analyses of the NIH cysteamine studies evaluating various cysteamine ophthalmic solution formulations from 1986 through 2005."|Any Time Point Up to 19 Years|One hundred sixty-one (161) participants were analyzed in the pre-specified intent-to-treat population [defined as patients who received study medication (between 1986 and 2005), and had a baseline and a post-baseline CCCS value]. After 2005, all participants enrolled received open-label treatment and only safety data was obtained.|||eyes|Participants||Number
2853665|NCT00001213|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Since efficacy of ophthalmic cysteamine was established and a New Drug Application (NDA) filed, the post-hoc primary outcome measure is the evaluation of safety information. There was no specified time frame for this outcome measure, as safety data was being collected until the drug became available for commercial purchase in May 2013.|Any Time Point up to 27 Years||||participants|||Number
2853666|NCT00001151|Primary|Number of Participants With Normal Serum Calcium Concentrations|Normal calcium concentration 8.2-10.6 mg/dL|1 year average||||participants|||Number
2853667|NCT00000378|Primary|HAMILTON Rating Scale for DEPRESSION Range|Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement|BASELINE COMPARED TO 12 WEEK MEASUREMENT|intent to treat analysis|||units on a scale||Standard Deviation|Mean
2853668|NCT00000371|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The slope of SANS total score from baseline to week 8 in the treatment and placebo groups on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.|Baseline, Week 4, Week 8||||units on a scale/weeks||Standard Error|Mean
2853669|NCT00000620|Secondary|First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event.|||participants|||Number
2853670|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.|||participants|||Number
2853671|NCT00000620|Secondary|Stroke in the Blood Pressure Trial.|Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke.|||participants|||Number
2853672|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.|||participants|||Number
2853673|NCT00000620|Secondary|Death From Any Cause in the Glycemia Trial.|"Time to death from any cause. Secondary measure for Glycemia Trial.~A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death.|||participants|||Number
2853674|NCT00000620|Primary|First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.|"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.|||participants|||Number
2853675|NCT00000575|Secondary|Standardized Depression Scale -- Children's Depression Inventory|Change in total score on the Children's Depression Inventory from baseline to the end of treatment, 4-6 years later. The total score ranges from 0-54 with higher scores indicating greater levels of depression.|4-6 years from baseline||||units on a scale||Standard Deviation|Mean
2853676|NCT00000575|Secondary|Change in Height From Baseline to End of Treatment, 4-6 Years Later|Change in standing height from baseline to end of treatment. Standing height is measured three times without shoes using a calibrated Harpenden stadiometer; the average of the three repeated heights to the nearest 0.1 cm is the height measure at either baseline or end of treatment.|4-6 years from baseline||||cm||Standard Deviation|Mean
2853677|NCT00000575|Secondary|Mortality|Counts of deaths from asthma.|4-6 years from baseline||||participants|||Number
2853678|NCT00000575|Secondary|Need for Urgent Care for Asthma|Counts during the period of treatment (4-6 years) of visits to emergency rooms or equivalent urgent care settings for asthma treatment.|4-6 years from baseline||||rate per 100 person years|||Number
2853679|NCT00000575|Secondary|Change From Baseline in the Rate of Asthma Free Days|Change from baseline proportion of days without asthma symptoms or other asthma related events to proportion of days during the 4-6 years of follow-up. Asthma free days were determined from daily asthma diaries kept from baseline to the end of treatment, 4-6 years later.|4-6 years from baseline||||days per month||Standard Deviation|Mean
2853680|NCT00000575|Secondary|Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs|Bronchial responsiveness to serial concentrations of inhaled methacholine solution (mg/ml) as measured by serial ratios of follow-up to baseline FEV1 (forced volume of air expired from the lungs in one second). A dose-response curve is calculated from the serial ratios in relation to the serial concentrations to determine PC20, the concentration associated with a 20% drop from baseline in FEV1; this PC20 is the outcome measure with units mg/ml of methacholine.|4-6 years from baseline||||mg/ml of methacholine||Standard Deviation|Geometric Mean
2853681|NCT00000575|Primary|Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period|Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.|At the end of treatment, 4-6 years from baseline assessment||||percentage of predicted value||Standard Deviation|Mean
2853682|NCT00000479|Primary|Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer||Average follow-up 10.1 years||||participants|||Number
2853683|NCT00000479|Primary|Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)||Average follow-up 10.1 years||||Participants|||Number
2853684|NCT00004500|Secondary|Number of Participants With Air Leaks|Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."|||participants|||Number
2853685|NCT00004500|Secondary|Incidence of Death||28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."|||participants|||Number
2853686|NCT00004500|Primary|Number of Days Receiving Mechanical Ventilation (MV)|A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."|||days||Standard Deviation|Mean
2853687|NCT00004445|Secondary|Distribution of Body Weight Through the Legs and Arms While Standing|Measure of how much weight is placed on the legs and arms while standing|Discharge, 1 follow-up between 6-12 months||||percentage of body weight||Standard Deviation|Mean
2853688|NCT00004445|Primary|Standing Performance|A measure of how long an individual can maintain a standing position.|Discharge, 1 follow-up between 6-12 months follow-up||||minutes||Standard Deviation|Mean
2853689|NCT00004412|Secondary|% Ulcers Which Completely Healed in Each Group, After 3 Months|Control Arm: given option to crossover to Treatment Arm if, ulcers have not closed after 12 weeks standard local care alone.|two additional courses of 8 week cycles|Per Protocol|||percentage of completely healed ulcers|Participants||Number
2853690|NCT00004412|Primary|Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area|"Treatment Arm: The AB is given as an IV infusion at 500 mg/kg over 6-9 hrs. 5 days per week for 12 weeks. After 12 weeks of therapy, if he ulcer has decreased by 25% , the AB may be continued for additional 8 weeks (twice) or, until ulcer closes plus 2 weeks, additionally.~Ulcers photographed, traced, and ulcer areas calculated by computerized planimetry."|participants were followed for an average of 3 months|Per protocol|||percentage of healed ulcers|Participants||Number
2853691|NCT00000143|Primary|Survival||3 years||||participants|||Number
2853692|NCT00000142|Primary|Survival||All patients enrolled will be followed until a common study closing date||||participants|||Number
2853693|NCT00000136|Primary|Mortality||All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.||||participants|||Number
2853694|NCT00000135|Primary|Mortality Rate|to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .|All patients enrolled were followed for a 17 month period or until a common study closing date||||deaths per person-year|||Number
2853695|NCT00000134|Primary|Morbidity|To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.|Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial||||participants|||Number
2853696|NCT00000125|Primary|Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients|Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.|5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)|1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops.|||percent of participants|||Number
